id|nct_id|outcome_id|non_inferiority_type|non_inferiority_description|param_type|param_value|dispersion_type|dispersion_value|p_value_modifier|p_value|ci_n_sides|ci_percent|ci_lower_limit|ci_upper_limit|ci_upper_limit_na_comment|p_value_description|method|method_description|estimate_description|groups_description|other_analysis_description
1583456|NCT04336475|2912258|Superiority|||||||0.564||||||The threshold for statistical significance was p=0.05. p value stands for the comparison of final oral aperture measurements between two groups. (after 2 months' period)|ANOVA|Repeated Measures ANOVA|||
1583457|NCT04322526|2912259|Other|Mechanistic hypothesis: naltrexone will block contextual processing.||||||0.0002|||||||t-test, 2 sided|||Changes in BOLD fMRI signal from the Placebo vs. the Naltrexone session.|
1583458|NCT04322526|2912260|Other|||||||0.01|||||||t-test, 2 sided|||Changes in BOLD signal in the rACC during the processing of contextual cues (pleasant > unpleasant).|
1583459|NCT04195880|2912336|Superiority||||||<|0.05|||||||negative-binomial regression coefficient|||We assumed the average monthly pre-intervention hospitalization rates of intervention and control CLCs were equal, so only average monthly post-intervention hospitalization rates might diverge. Each CLC had its own start month and contributed 18 months pre-intervention and 18 months post-intervention. Hospitalizations rates were modeled using a multilevel negative-binomial regression because it allows for over-dispersion, which is commonly observed with medical events such as a count.|
1583460|NCT04179838|2912347|Superiority|||||||0.58|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.|
1583461|NCT04179838|2912348|Superiority|||||||0.5|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.|
1583462|NCT04179838|2912349|Superiority|||||||0.28|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.|
1583463|NCT04179838|2912350|Superiority|||||||0.08|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.|
1583464|NCT04179838|2912351|Superiority|||||||0.63|||||||t-test, 2 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.|
1583465|NCT04179838|2912352|Superiority|||||||0.021|||||||t-test, 1 sided|||Null hypothesis is that there was no change after the sleep-deprived relative to the non-sleep deprived intervention. One sample t-test on percentage change in the sleep-deprived relative to non-sleep deprived phase.|
1583466|NCT04179838|2912353|Superiority|||||||0.001||||||Corrected for multiple comparisons in piriform cortex|t-test, 1 sided|||Null hypothesis is that there was no difference in decoding accuracy between sleep-deprived and non-sleep deprived interventions. Paired t-test on decoding accuracy from both phases (sleep-deprived minus non-sleep deprived) against the null hypothesis of no difference.|
1583467|NCT04149925|2912378|Superiority|||||||0.01||||||Significant when p<0.05|t-test, 2 sided||||
1583468|NCT04123665|2912408|Superiority||Mean Difference (Net)|-0.07|||<|0.0001|2-Sided|95.0|-0.11|-0.04|||ANCOVA|Analysis of Covariance (ANCOVA) with factors for treatment group and gender, and the baseline whole mouth mean BI and whole mouth MGI as covariates.|Difference is first named treatment (experimental) minus second named treatment (control).||
1583469|NCT04109703|2912422|Other|The hypothesis is that the high level pulsed heat group will show statistically more pain relief than the low level steady heat group.|||||<|0.05|||||||Regression, Linear|Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level.||Demographic and clinical characteristics were tabulated by randomization group. The primary outcome was change in pain score from baseline to 30 minutes after treatment ended. Linear regression was used to compare differences in primary outcome between treatment and control groups adjusting for initial pain level. Unadjusted comparisons are also presented. Change in pain scores at each other post baseline time point were similarly analyzed.|
1583470|NCT04091659|2912437|Equivalence|To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.|Mean Difference (Final Values)|0.26||||0.02|2-Sided|95.0|0.02|0.5|||SEM||The control group, standard education, was the reference||
1583471|NCT04091659|2912438|Equivalence|To determine if the two training approaches were comparable to one another a margin of +/- 1 was used in differences of both OOKS and OOAS scale scores based on previously established literature. An equivalence test of differences using two one-sided tests on data from a cluster-randomized design was conducted using structural equation modeling. Sample sizes of 35 and 57 in group two, obtained by sampling 9 clusters, achieve 85% power to detect equivalence. The significance level is 0.05.|Mean Difference (Final Values)|-0.18||||0.65|2-Sided|95.0|-0.85|0.49|||SEM||||The control group, standard education was the reference for this model.
1583472|NCT04072432|2912459|Other|Analyses of variance for repeated measures (ANOVA)|Mean Difference (Final Values)|18.0||||0.05|2-Sided|||||p values were corrected for multiple comparisons by the Bonferroni test if required|ANOVA|ANOVA for repeated measures|||
1583473|NCT04035564|2912510|Superiority||Hazard Ratio (HR)|0.62||||0.57|2-Sided||||||Regression, Cox||||
1583474|NCT04035564|2912510|Superiority|||||||0.33|||||||Chi-squared||||
1583475|NCT04035564|2912511|Superiority||Risk Ratio (RR)|0.8||||0.7|2-Sided|95.0|0.266|2.448|||Chi-squared||||
1583476|NCT04035564|2912512|Superiority||Risk Ratio (RR)|1.09||||0.84|2-Sided|95.0|0.169|7.096|||Chi-squared||||
1583477|NCT04035564|2912513|Superiority||Risk Ratio (RR)|0.75||||0.55|2-Sided|95.0|0.296|1.932|||Chi-squared||||
1583478|NCT04035564|2912514|Superiority||Mean Difference (Final Values)|-39.38|Standard Error of the Mean|17.22||0.028|2-Sided|95.0|-74.18|-4.57|||ANOVA||||
1583479|NCT04035564|2912514|Superiority||Mean Difference (Final Values)|-39.38|Standard Error of the Mean|17.22||0.028|2-Sided|95.0|-74.18|-4.57|||t-test, 2 sided||||
1583576|NCT03975790|2912653|Superiority|||||||0.1226|||||||t-test|||12 months before index date|
1583480|NCT04035564|2912515|Superiority||Mean Difference (Final Values)|-3.78|Standard Error of the Mean|2.299||0.107|2-Sided|95.0|-8.43|0.85|||ANOVA||||
1583481|NCT04035564|2912515|Superiority||Mean Difference (Final Values)|-3.788|Standard Error of the Mean|2.299||0.107|2-Sided|95.0|-8.43|0.858|||t-test, 2 sided||||
1583482|NCT04035564|2912516|Superiority||Mean Difference (Final Values)|-2.86|Standard Error of the Mean|1.286||0.032|2-Sided|95.0|-5.461|-0.261|||ANOVA||||
1583483|NCT04035564|2912516|Superiority||Mean Difference (Final Values)|-2.861|Standard Error of the Mean|1.286||0.032|2-Sided|95.0|-5.461|-0.261|||t-test, 2 sided||||
1583484|NCT04035564|2912517|Superiority||Risk Ratio (RR)|1.21||||0.89|2-Sided|95.0|0.081|18.09|||Chi-squared||||
1583485|NCT04035564|2912518|Superiority||Risk Ratio (RR)|0.2||||0.71|2-Sided|95.0|0.026|1.533|||Chi-squared||||
1583486|NCT04027218|2912540|Superiority||Median Difference (Net)|-1.885||||0.059|2-Sided||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.||
1583487|NCT04027218|2912540|Superiority||Median Difference (Net)|-0.327||||0.744|2-Sided||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.||
1583488|NCT04027218|2912540|Superiority||Median Difference (Net)|-0.672||||0.502|2-Sided||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the absorbance comparing hemolysis in blood samples performed by clinical practice against to the corresponding intervention.||
1583489|NCT04027218|2912542|Superiority||Median Difference (Net)|-0.858||||0.391|2-Sided||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.||
1583490|NCT04027218|2912542|Superiority||Median Difference (Net)|-1.267||||0.205|2-Sided||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.||
1583491|NCT04027218|2912542|Superiority||Median Difference (Net)|-1.073||||0.863|2-Sided||||||Wilcoxon (Mann-Whitney)||Estimated value corresponds with the number of negative changes, which implies participants with decrease in VAS score.||
1583492|NCT04027218|2912543|Superiority||Median Difference (Net)|-4.099||||0|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1583493|NCT04027218|2912543|Superiority||Median Difference (Net)|-3.619||||0|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1583494|NCT04027218|2912543|Superiority||Median Difference (Net)|-4.179||||0|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1583495|NCT04027218|2912544|Superiority||Odds Ratio (OR)|1.9||||0.004|2-Sided|95.0|1.87|1.92|||McNemar||||
1583496|NCT04027218|2912544|Superiority||Odds Ratio (OR)|1.92||||0.002|2-Sided|95.0|1.7|2.13|||McNemar||||
1583497|NCT04027218|2912544|Superiority||Odds Ratio (OR)|2.57||||0.001|2-Sided|95.0|2.34|2.79|||McNemar||||
1583498|NCT04018001|2912552|Superiority|||||||0.4914|||||||Chi-squared||||
1583499|NCT04018001|2912553|Superiority|||||||0.0624|||||||Chi-squared||||
1583500|NCT04018001|2912554|Superiority||Odds Ratio (OR)|1.1077385||||0.451|2-Sided|95.0|0.8489444|1.4454238||To better assess true effect of treatment,analysis with participant’s baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic||||
1583501|NCT04018001|2912554|Superiority|||||||0.3584|||||||Chi-squared||||
1583502|NCT04018001|2912555|Superiority||Difference in LS Means|-0.008587||||0.6376|2-Sided|95.0|-0.044317|0.0271416||To better assess true effect of treatment,analysis with participant’s baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model||||
1583503|NCT04018001|2912555|Superiority|||||||0.9031|||||||t-test, 2 sided||||
1583504|NCT04018001|2912556|Superiority||Odds Ratio (OR)|1.4143816||||0.0364|2-Sided|95.0|1.0221455|1.9571335||To better assess true effect of treatment,analysis with participant’s baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic||||
1583505|NCT04018001|2912556|Superiority|||||||0.02|||||||Chi-squared||||
1583506|NCT04018001|2912557|Superiority||Difference in LS Means|0.0151242||||0.1194|2-Sided|95.0|-0.003908|0.0341568||To better assess true effect of treatment,analysis with participant’s baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model||||
1583507|NCT04018001|2912557|Superiority|||||||0.113|||||||t-test, 2 sided||||
1583508|NCT04018001|2912558|Superiority||Hazard Ratio (HR)|1.1225||||0.3354|2-Sided|95.0|0.8873|1.4201||To better assess true effect of treatment,analysis with participant’s baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Cox||||
1583509|NCT04018001|2912558|Superiority|||||||0.4595|||||||t-test, 2 sided||||
1583510|NCT04018001|2912559|Superiority||Odds Ratio (OR)|1.5211586||||0.0025|2-Sided|95.0|1.1594614|1.9956882||To better assess true effect of treatment,analysis with participant’s baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic||||
1583511|NCT04018001|2912559|Superiority|||||||0.001|||||||Chi-squared||||
1583512|NCT04018001|2912560|Superiority||Difference in LS Means|0.0104065||||0.6143|2-Sided|95.0|-0.030062|0.0508746||To better assess true effect of treatment,analysis with participant’s baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model||||
1583513|NCT04018001|2912560|Superiority|||||||0.4071|||||||t-test, 2 sided||||
1583514|NCT04018001|2912561|Superiority||Odds Ratio (OR)|1.7910474||||0.0002|2-Sided|95.0|1.3167136|2.4362554||To better assess true effect of treatment,analysis with participant’s baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic||||
1583515|NCT04018001|2912561|Superiority|||||||0.0002|||||||Chi-squared||||
1583516|NCT04018001|2912562|Superiority||Difference in Least Squares (LS) Means|0.0300853||||0.0047|2-Sided|95.0|0.0092322|0.0509385||To better assess true effect of treatment,analysis with participant’s baseline characteristic was adjusted to remove influence on the outcome measure.|Generalized linear model||||
1583517|NCT04018001|2912562|Superiority|||||||0.0123|||||||t-test, 2 sided||||
1583577|NCT03975790|2912653|Superiority|||||||0.0876|||||||t-test|||12 months before index date|
1583578|NCT03975790|2912653|Superiority|||||||0.7881|||||||t-test|||11 months before index date|
1583518|NCT04018001|2912563|Superiority||Hazard Ratio (HR)|0.9022||||0.2629|2-Sided|95.0|0.7534|1.0803||To better assess true effect of treatment,analysis with participant’s baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Cox||||
1583519|NCT04018001|2912563|Superiority|||||||0.3564|||||||t-test, 2 sided||||
1583520|NCT04018001|2912564|Superiority||Odds Ratio (OR)|1.410198||||0.0227|2-Sided|95.0|1.0492535|1.8953079||To better assess true effect of treatment,analysis with participant’s baseline characteristic was adjusted to remove influence on the outcome measure.|Regression, Logistic||||
1583521|NCT04018001|2912564|Superiority|||||||0.0115|||||||Chi-squared||||
1583522|NCT04012970|2912599|Superiority||||||<|0.001|||||||ANOVA|2-way, repeated measures|||
1583523|NCT04012970|2912600|Superiority||||||<|0.01|||||||ANOVA|2-way, repeated measures|||
1583524|NCT04012970|2912601|Superiority||||||<|0.05|||||||ANCOVA|||Tone change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).|
1583525|NCT04012970|2912601|Superiority||||||<|0.01|||||||ANOVA|2-way, repeated measures|||
1583526|NCT04012970|2912602|Superiority||||||<|0.05|||||||ANCOVA|||Tone change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).|
1583527|NCT04012970|2912602|Superiority||||||<|0.01|||||||ANOVA|2-way, repeated measures|||
1583528|NCT04012970|2912603|Superiority||||||<|0.01|||||||ANCOVA|||Stiffness change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).|
1583529|NCT04012970|2912603|Superiority||||||<|0.01|||||||ANOVA|2-way, repeated measures|||
1583530|NCT04012970|2912604|Superiority||||||<|0.01|||||||ANCOVA|||Stiffness change ran with covariates (baseline stiffness, BMI, ODI, waist circumference, height and gender).|
1583531|NCT04012970|2912604|Superiority||||||<|0.05|||||||ANOVA|2-way, repeated measures|||
1583532|NCT04000815|2912607|Other||||||<|0.05|||||||Bi-variate correlation analyses|Bi-variate correlation analyses were performed for all subjects in groups 1 and 2 between serum CNP and E2 using Spearman test.|||
1583533|NCT04000815|2912608|Other||||||<|0.05|||||||Bi-variate correlation|Spearman test was applied.|||
1583534|NCT04000815|2912609|Other||||||<|0.05|||||||Bi-variate correlation analysis|Bi-variate correlation analyses were performed in groups 1 and 2 between serum CNP and FSH and between serum CNP and LH using Spearman test.|||
1583535|NCT04000815|2912610|Other||||||<|0.017||||||p-value is adjusted for multiple comparisons|Kruskal-Wallis||||
1583536|NCT03992482|2912614|Other|||||||0.0002|||||||Mixed Models Analysis||||
1583537|NCT03992482|2912615|Other|||||||0.0044|||||||Mixed Models Analysis||||
1583538|NCT03992482|2912616|Other|||||||1|||||||Kruskal-Wallis||||
1583539|NCT03975790|2912653|Superiority|||||||0.5965|||||||t-test|||12 months after index date|
1583540|NCT03975790|2912653|Superiority|||||||0.7105|||||||t-test|||12 months after index date|
1583541|NCT03975790|2912653|Superiority|||||||0.5699|||||||t-test|||12 months after index date|
1583542|NCT03975790|2912653|Superiority|||||||0.6629|||||||t-test|||11 months after index date|
1583543|NCT03975790|2912653|Superiority|||||||0.6621|||||||t-test|||11 months after index date|
1583544|NCT03975790|2912653|Superiority|||||||0.1948|||||||t-test|||11 months after index date|
1583545|NCT03975790|2912653|Superiority|||||||0.2215|||||||t-test|||10 months after index date|
1583546|NCT03975790|2912653|Superiority|||||||0.0551|||||||t-test|||10 months after index date|
1583547|NCT03975790|2912653|Superiority|||||||0.6295|||||||t-test|||10 months after index date|
1583548|NCT03975790|2912653|Superiority|||||||0.8553|||||||t-test|||9 months after index date|
1583549|NCT03975790|2912653|Superiority|||||||0.1536|||||||t-test|||9 months after index date|
1583550|NCT03975790|2912653|Superiority|||||||0.0775|||||||t-test|||9 months after index date|
1583551|NCT03975790|2912653|Superiority|||||||0.5993|||||||t-test|||8 months after index date|
1583552|NCT03975790|2912653|Superiority|||||||0.9075|||||||t-test|||8 months after index date|
1583553|NCT03975790|2912653|Superiority|||||||0.3075|||||||t-test|||8 months after index date|
1583554|NCT03975790|2912653|Superiority|||||||0.3834|||||||t-test|||7 months after index date|
1583555|NCT03975790|2912653|Superiority|||||||0.3885|||||||t-test|||7 months after index date|
1583556|NCT03975790|2912653|Superiority|||||||0.9097|||||||t-test|||7 months after index date|
1583557|NCT03975790|2912653|Superiority|||||||0.3842|||||||t-test|||6 months after index date|
1583558|NCT03975790|2912653|Superiority|||||||0.1142|||||||t-test|||6 months after index date|
1583559|NCT03975790|2912653|Superiority|||||||0.0023|||||||t-test|||6 months after index date|
1583560|NCT03975790|2912653|Superiority|||||||0.5647|||||||t-test|||5 months after index date|
1583561|NCT03975790|2912653|Superiority|||||||0.9688|||||||t-test|||5 months after index date|
1583562|NCT03975790|2912653|Superiority|||||||0.2212|||||||t-test|||5 months after index date|
1583563|NCT03975790|2912653|Superiority|||||||0.0065|||||||t-test|||4 months after index date|
1583564|NCT03975790|2912653|Superiority|||||||0.0013|||||||t-test|||4 months after index date|
1583565|NCT03975790|2912653|Superiority|||||||0.0926|||||||t-test|||4 months after index date|
1583566|NCT03975790|2912653|Superiority|||||||0.4753|||||||t-test|||3 months after index date|
1583567|NCT03975790|2912653|Superiority|||||||0.6257|||||||t-test|||3 months after index date|
1583568|NCT03975790|2912653|Superiority|||||||0.2953|||||||t-test|||3 months after index date|
1583569|NCT03975790|2912653|Superiority|||||||0.7643|||||||t-test|||2 months after index date|
1583570|NCT03975790|2912653|Superiority|||||||0.9775|||||||t-test|||2 months after index date|
1583571|NCT03975790|2912653|Superiority|||||||0.7051|||||||t-test|||2 months after index date|
1583572|NCT03975790|2912653|Superiority|||||||0.6189|||||||t-test|||1 month after index date|
1583573|NCT03975790|2912653|Superiority|||||||0.2551|||||||t-test|||1 month after index date|
1583574|NCT03975790|2912653|Superiority|||||||0.0336|||||||t-test|||1 month after index date|
1583575|NCT03975790|2912653|Superiority|||||||0.9753|||||||t-test|||12 months before index date|
1583579|NCT03975790|2912653|Superiority|||||||0.3228|||||||t-test|||11 months before index date|
1583580|NCT03975790|2912653|Superiority|||||||0.501|||||||t-test|||11 months before index date|
1583581|NCT03975790|2912653|Superiority|||||||0.2679|||||||t-test|||10 months before index date|
1583582|NCT03975790|2912653|Superiority|||||||0.6748|||||||t-test|||10 months before index date|
1583583|NCT03975790|2912653|Superiority|||||||0.0316|||||||t-test|||10 months before index date|
1583584|NCT03975790|2912653|Superiority|||||||0.904|||||||t-test|||9 months before index date|
1583585|NCT03975790|2912653|Superiority|||||||0.1032|||||||t-test|||9 months before index date|
1583586|NCT03975790|2912653|Superiority|||||||0.0199|||||||t-test|||9 months before index date|
1583587|NCT03975790|2912653|Superiority|||||||0.7191|||||||t-test|||8 months before index date|
1583588|NCT03975790|2912653|Superiority|||||||0.4377|||||||t-test|||8 months before index date|
1583589|NCT03975790|2912653|Superiority|||||||0.0345|||||||t-test|||8 months before index date|
1583590|NCT03975790|2912653|Superiority|||||||0.4074|||||||t-test|||7 months before index date|
1583591|NCT03975790|2912653|Superiority|||||||0.2586|||||||t-test|||7 months before index date|
1583592|NCT03975790|2912653|Superiority|||||||0.6098|||||||t-test|||7 months before index date|
1583593|NCT03975790|2912653|Superiority|||||||0.2065|||||||t-test|||6 months before index date|
1583594|NCT03975790|2912653|Superiority|||||||0.3011|||||||t-test|||6 months before index date|
1583595|NCT03975790|2912653|Superiority|||||||0.2009|||||||t-test|||6 months before index date|
1583596|NCT03975790|2912653|Superiority|||||||0.4491|||||||t-test|||5 months before index date|
1583597|NCT03975790|2912653|Superiority|||||||0.5631|||||||t-test|||5 months before index date|
1583598|NCT03975790|2912653|Superiority|||||||0.3256|||||||t-test|||5 months before index date|
1583599|NCT03975790|2912653|Superiority|||||||0.627|||||||t-test|||4 months before index date|
1583600|NCT03975790|2912653|Superiority|||||||0.8273|||||||t-test|||4 months before index date|
1583601|NCT03975790|2912653|Superiority|||||||0.2905|||||||t-test|||4 months before index date|
1583602|NCT03975790|2912653|Superiority|||||||0.2057|||||||t-test|||3 months before index date|
1583603|NCT03975790|2912653|Superiority|||||||0.1476|||||||t-test|||3 months before index date|
1583604|NCT03975790|2912653|Superiority|||||||0.7004|||||||t-test|||3 months before index date|
1583605|NCT03975790|2912653|Superiority|||||||0.2126|||||||t-test|||2 months before index date|
1583606|NCT03975790|2912653|Superiority|||||||0.0126|||||||t-test|||2 months before index date|
1583607|NCT03975790|2912653|Superiority|||||||0.2799|||||||t-test|||2 months before index date|
1583608|NCT03975790|2912653|Superiority|||||||0.8715|||||||t-test|||1 month before index date|
1583609|NCT03975790|2912653|Superiority|||||||0.0162|||||||t-test|||1 month before index date|
1583610|NCT03975790|2912653|Superiority|||||||0.0063|||||||t-test|||1 month before index date|
1583611|NCT03975790|2912654|Superiority|||||||0.4817|||||||t-test|||12 month after index date|
1583612|NCT03975790|2912654|Superiority|||||||0.8027|||||||t-test|||12 month after index date|
1583613|NCT03975790|2912654|Superiority|||||||0.3675|||||||t-test|||12 month after index date|
1583614|NCT03975790|2912654|Superiority|||||||0.6953|||||||t-test|||11 months after index date|
1583615|NCT03975790|2912654|Superiority|||||||0.6712|||||||t-test|||11 month after index date|
1583616|NCT03975790|2912654|Superiority|||||||0.2307|||||||t-test|||11 month after index date|
1583617|NCT03975790|2912654|Superiority|||||||0.7643|||||||t-test|||10 months after index date|
1583618|NCT03975790|2912654|Superiority|||||||0.7866|||||||t-test|||10 month after index date|
1583619|NCT03975790|2912654|Superiority|||||||0.6373|||||||t-test|||10 month after index date|
1583620|NCT03975790|2912654|Superiority|||||||0.1695|||||||t-test|||9 month after index date|
1583621|NCT03975790|2912654|Superiority|||||||0.0497|||||||t-test|||9 month after index date|
1583622|NCT03975790|2912654|Superiority|||||||0.6373|||||||t-test|||9 month after index date|
1583623|NCT03975790|2912654|Superiority|||||||0.4949|||||||t-test|||8 month after index date|
1583624|NCT03975790|2912654|Superiority|||||||0.88|||||||t-test|||8 month after index date|
1583625|NCT03975790|2912654|Superiority|||||||0.0944|||||||t-test|||8 month after index date|
1583626|NCT03975790|2912654|Superiority|||||||0.5831|||||||t-test|||7 month after index date|
1583627|NCT03975790|2912654|Superiority|||||||0.4803|||||||t-test|||7 month after index date|
1583628|NCT03975790|2912654|Superiority|||||||0.3731|||||||t-test|||7 month after index date|
1583629|NCT03975790|2912654|Superiority|||||||0.4288|||||||t-test|||6 month after index date|
1583630|NCT03975790|2912654|Superiority|||||||0.7037|||||||t-test|||6 month after index date|
1583631|NCT03975790|2912654|Superiority|||||||0.0805|||||||t-test|||6 month after index date|
1583632|NCT03975790|2912654|Superiority|||||||0.6191|||||||t-test|||5 month after index date|
1583633|NCT03975790|2912654|Superiority|||||||0.9445|||||||t-test|||5 month after index date|
1583634|NCT03975790|2912654|Superiority|||||||0.4455|||||||t-test|||5 month after index date|
1583635|NCT03975790|2912654|Superiority|||||||0.9481|||||||t-test|||4 month after index date|
1583636|NCT03975790|2912654|Superiority|||||||0.1147|||||||t-test|||4 month after index date|
1583637|NCT03975790|2912654|Superiority|||||||0.0307|||||||t-test|||4 month after index date|
1583638|NCT03975790|2912654|Superiority|||||||0.4162|||||||t-test|||3 month after index date|
1583639|NCT03975790|2912654|Superiority|||||||0.5889|||||||t-test|||3 month after index date|
1583640|NCT03975790|2912654|Superiority|||||||0.2453|||||||t-test|||3 month after index date|
1583641|NCT03975790|2912654|Superiority|||||||0.7267|||||||t-test|||2 month after index date|
1583642|NCT03975790|2912654|Superiority|||||||0.8111|||||||t-test|||2 month after index date|
1583643|NCT03975790|2912654|Superiority|||||||0.8461|||||||t-test|||2 month after index date|
1583644|NCT03975790|2912654|Superiority|||||||0.335|||||||t-test|||1 month after index date|
1583645|NCT03975790|2912654|Superiority|||||||0.0776|||||||t-test|||1 month after index date|
1583646|NCT03975790|2912654|Superiority|||||||0.6674|||||||t-test|||1 month after index date|
1583647|NCT03975790|2912654|Superiority|||||||0.9374|||||||t-test|||12 months before index date|
1583648|NCT03975790|2912654|Superiority|||||||0.96|||||||t-test|||12 months before index date|
1583649|NCT03975790|2912654|Superiority|||||||0.854|||||||t-test|||12 months before index date|
1583650|NCT03975790|2912654|Superiority|||||||0.4292|||||||t-test|||11 months before index date|
1583651|NCT03975790|2912654|Superiority|||||||0.396|||||||t-test|||11 months before index date|
1583652|NCT03975790|2912654|Superiority|||||||0.0934|||||||t-test|||11 months before index date|
1583653|NCT03975790|2912654|Superiority|||||||0.7797|||||||t-test|||10 months before index date|
1583654|NCT03975790|2912654|Superiority|||||||0.626|||||||t-test|||10 months before index date|
1583655|NCT03975790|2912654|Superiority|||||||0.936|||||||t-test|||10 months before index date|
1583656|NCT03975790|2912654|Superiority|||||||0.359|||||||t-test|||9 months before index date|
1583657|NCT03975790|2912654|Superiority|||||||0.6999|||||||t-test|||9 months before index date|
1583658|NCT03975790|2912654|Superiority|||||||0.0541|||||||t-test|||9 months before index date|
1583659|NCT03975790|2912654|Superiority|||||||0.6328|||||||t-test|||8 months before index date|
1583660|NCT03975790|2912654|Superiority|||||||0.6978|||||||t-test|||8 months before index date|
1583661|NCT03975790|2912654|Superiority|||||||0.767|||||||t-test|||8 months before index date|
1583662|NCT03975790|2912654|Superiority|||||||0.4021|||||||t-test|||7 months before index date|
1583663|NCT03975790|2912654|Superiority|||||||0.5783|||||||t-test|||7 months before index date|
1583664|NCT03975790|2912654|Superiority|||||||0.3091|||||||t-test|||7 months before index date|
1583665|NCT03975790|2912654|Superiority|||||||0.2662|||||||t-test|||6 months before index date|
1583666|NCT03975790|2912654|Superiority|||||||0.2874|||||||t-test|||6 months before index date|
1583667|NCT03975790|2912654|Superiority|||||||0.7892|||||||t-test|||6 months before index date|
1583668|NCT03975790|2912654|Superiority|||||||0.4321|||||||t-test|||5 months before index date|
1583669|NCT03975790|2912654|Superiority|||||||0.5122|||||||t-test|||5 months before index date|
1583670|NCT03975790|2912654|Superiority|||||||0.5685|||||||t-test|||5 months before index date|
1583671|NCT03975790|2912654|Superiority|||||||0.7688|||||||t-test|||4 months before index date|
1583672|NCT03975790|2912654|Superiority|||||||0.9564|||||||t-test|||4 months before index date|
1583673|NCT03975790|2912654|Superiority|||||||0.6104|||||||t-test|||4 months before index date|
1583674|NCT03975790|2912654|Superiority|||||||0.1772|||||||t-test|||3 months before index date|
1583675|NCT03975790|2912654|Superiority|||||||0.6807|||||||t-test|||3 months before index date|
1583676|NCT03975790|2912654|Superiority|||||||0.1188|||||||t-test|||3 months before index date|
1583677|NCT03975790|2912654|Superiority|||||||0.153|||||||t-test|||2 months before index date|
1583678|NCT03975790|2912654|Superiority|||||||0.0435|||||||t-test|||2 months before index date|
1583679|NCT03975790|2912654|Superiority|||||||0.8641|||||||t-test|||2 months before index date|
1583680|NCT03975790|2912654|Superiority|||||||0.4432|||||||t-test|||1 months before index date|
1583681|NCT03975790|2912654|Superiority|||||||0.3041|||||||t-test|||1 months before index date|
1583682|NCT03975790|2912654|Superiority|||||||0.0051|||||||t-test|||1 months before index date|
1583683|NCT03975790|2912655|Superiority|||||||0.0535|||||||t-test||||
1583684|NCT03975790|2912655|Superiority|||||||0.0014|||||||t-test||||
1583685|NCT03975790|2912655|Superiority|||||||0.2614|||||||t-test||||
1583686|NCT03975790|2912656|Superiority|||||||0.2964|||||||t-test||||
1583687|NCT03975790|2912656|Superiority|||||||0.9431|||||||t-test||||
1583688|NCT03975790|2912656|Superiority|||||||0.0003|||||||t-test||||
1583689|NCT03975790|2912657|Superiority|||||||0.8349|||||||t-test||||
1583690|NCT03975790|2912657|Superiority|||||||0.9816|||||||t-test||||
1583691|NCT03975790|2912657|Superiority|||||||0.6963|||||||t-test||||
1583692|NCT03975790|2912658|Superiority|||||||0.374|||||||t-test||||
1583693|NCT03975790|2912658|Superiority|||||||0.9313|||||||t-test||||
1583694|NCT03975790|2912658|Superiority|||||||0.0536|||||||t-test||||
1583695|NCT03975790|2912659|Superiority|||||||0.7043|||||||t-test||||
1583696|NCT03975790|2912659|Superiority|||||||0.7391|||||||t-test||||
1583697|NCT03975790|2912659|Superiority|||||||0.8698|||||||t-test||||
1583698|NCT03975790|2912660|Superiority|||||||0.0046|||||||Chi-squared||||
1583699|NCT03975790|2912660|Superiority|||||||0.0425|||||||Chi-squared||||
1583700|NCT03975790|2912660|Superiority|||||||0.1208|||||||Chi-squared||||
1583701|NCT03975790|2912661|Superiority|||||||0.8517|||||||Chi-squared||||
1583702|NCT03975790|2912661|Superiority|||||||0.7623|||||||Chi-squared||||
1583703|NCT03975790|2912661|Superiority|||||||0.9141|||||||Chi-squared||||
1583704|NCT03975790|2912662|Superiority|||||||0.3088|||||||Chi-squared||||
1583705|NCT03975790|2912662|Superiority|||||||0.5926|||||||Chi-squared||||
1583706|NCT03975790|2912662|Superiority|||||||0.1702|||||||Chi-squared||||
1583707|NCT03975790|2912663|Superiority|||||||0.0439|||||||Chi-squared||||
1583708|NCT03975790|2912663|Superiority|||||||0.2043|||||||Chi-squared||||
1583709|NCT03975790|2912663|Superiority|||||||0.1984|||||||Chi-squared||||
1583710|NCT03975790|2912664|Superiority|||||||0.181|||||||Chi-squared||||
1583711|NCT03975790|2912664|Superiority|||||||0.0722|||||||Chi-squared||||
1583712|NCT03975790|2912664|Superiority|||||||0.7871|||||||Chi-squared||||
1583713|NCT03975790|2912666|Superiority|||||||0.395|||||||Chi-squared||||
1583714|NCT03975790|2912666|Superiority|||||||0.4184|||||||Chi-squared||||
1583715|NCT03975790|2912666|Superiority|||||||0.8035|||||||Chi-squared||||
1583716|NCT03975790|2912667|Superiority|||||||0.9676|||||||Chi-squared||||
1583717|NCT03975790|2912667|Superiority|||||||0.679|||||||Chi-squared||||
1583718|NCT03975790|2912667|Superiority|||||||0.5435|||||||Chi-squared||||
1583719|NCT03975790|2912668|Superiority|||||||0.7055|||||||Chi-squared||||
1583720|NCT03975790|2912668|Superiority|||||||0.597|||||||Chi-squared||||
1583721|NCT03975790|2912669|Superiority|||||||0.7635|||||||Chi-squared||||
1583722|NCT03975790|2912669|Superiority|||||||0.591|||||||Chi-squared||||
1583723|NCT03975790|2912669|Superiority|||||||0.8135|||||||Chi-squared||||
1583724|NCT03975790|2912670|Superiority|||||||0.9612|||||||Chi-squared||||
1583725|NCT03975790|2912670|Superiority|||||||0.4519|||||||Chi-squared||||
1583726|NCT03975790|2912670|Superiority|||||||0.361|||||||Chi-squared||||
1583727|NCT03975790|2912672|Superiority|||||||0.3336|||||||Chi-squared||||
1583728|NCT03975790|2912672|Superiority|||||||0.2105|||||||Chi-squared||||
1583729|NCT03975790|2912672|Superiority|||||||0.8966|||||||Chi-squared||||
1583730|NCT03975790|2912673|Superiority|||||||0.4434|||||||Chi-squared||||
1583731|NCT03975790|2912673|Superiority|||||||0.7121|||||||Chi-squared||||
1583732|NCT03975790|2912673|Superiority|||||||0.5146|||||||Chi-squared||||
1583733|NCT03975790|2912674|Superiority|||||||0.1897|||||||Chi-squared||||
1583734|NCT03975790|2912674|Superiority|||||||0.7315|||||||Chi-squared||||
1583735|NCT03975790|2912674|Superiority|||||||0.0654|||||||Chi-squared||||
1583736|NCT03975790|2912675|Superiority|||||||0.3336|||||||Chi-squared||||
1583737|NCT03975790|2912675|Superiority|||||||0.3278|||||||Chi-squared||||
1583738|NCT03975790|2912675|Superiority|||||||0.8424|||||||Chi-squared||||
1583739|NCT03975790|2912676|Superiority|||||||0.2109|||||||Chi-squared||||
1583740|NCT03975790|2912676|Superiority|||||||0.1231|||||||Chi-squared||||
1583741|NCT03975790|2912676|Superiority|||||||0.5157|||||||Chi-squared||||
1583742|NCT03975790|2912677|Superiority|||||||0.0065|||||||Chi-squared||||
1583743|NCT03975790|2912677|Superiority||||||<|0.0001|||||||Chi-squared||||
1583744|NCT03975790|2912677|Superiority||||||<|0.088|||||||Chi-squared||||
1583745|NCT03975790|2912678|Superiority|||||||0.9861|||||||Chi-squared|||Hydroxychloroquine|
1583746|NCT03975790|2912678|Superiority|||||||0.7309|||||||Chi-squared|||Hydroxychloroquine|
1583747|NCT03975790|2912678|Superiority|||||||0.6617|||||||Chi-squared|||Hydroxychloroquine|
1583748|NCT03975790|2912678|Superiority|||||||0.5065|||||||Chi-squared|||Sulfasalazine|
1583749|NCT03975790|2912678|Superiority|||||||0.4456|||||||Chi-squared|||Sulfasalazine|
1583750|NCT03975790|2912678|Superiority|||||||0.0225|||||||Chi-squared|||Sulfasalazine|
1583751|NCT03975790|2912678|Superiority|||||||0.2629|||||||Chi-squared|||Leflunomide|
1583752|NCT03975790|2912678|Superiority|||||||0.9978|||||||Chi-squared|||Leflunomide|
1583753|NCT03975790|2912678|Superiority|||||||0.0309|||||||Chi-squared|||Leflunomide|
1583754|NCT03975790|2912679|Superiority||||||<|0.0001|||||||t-test||||
1583755|NCT03975790|2912679|Superiority||||||<|0.0001|||||||t-test||||
1583756|NCT03975790|2912679|Superiority||||||<|0.0001|||||||t-test||||
1583757|NCT03975790|2912681|Superiority|||||||0.7095|||||||Chi-squared||||
1583758|NCT03975790|2912681|Superiority|||||||0.1336|||||||Chi-squared||||
1583759|NCT03975790|2912681|Superiority|||||||0.2036|||||||Chi-squared||||
1583760|NCT03975790|2912682|Superiority|||||||0.3336|||||||Chi-squared||||
1583761|NCT03975790|2912682|Superiority|||||||0.3278|||||||Chi-squared||||
1583762|NCT03975790|2912682|Superiority|||||||0.8424|||||||Chi-squared||||
1583763|NCT03975790|2912683|Superiority|||||||0.1204|||||||Chi-squared|||Discontinue without switch or restart|
1583764|NCT03975790|2912683|Superiority|||||||0.0024|||||||Chi-squared|||Discontinue without switch or restart|
1583765|NCT03975790|2912683|Superiority|||||||0.2241|||||||Chi-squared|||Discontinue without switch or restart|
1583766|NCT03975790|2912683|Superiority|||||||0.7095|||||||Chi-squared|||Discontinue then restart|
1583767|NCT03975790|2912683|Superiority|||||||0.1336|||||||Chi-squared|||Discontinue then restart|
1583768|NCT03975790|2912683|Superiority|||||||0.2036|||||||Chi-squared|||Discontinue then restart|
1583769|NCT03975790|2912683|Superiority|||||||0.3914|||||||Chi-squared|||Discontinue then switch|
1583770|NCT03975790|2912683|Superiority|||||||0.0552|||||||Chi-squared|||Discontinue then switch|
1583771|NCT03975790|2912683|Superiority|||||||0.3975|||||||Chi-squared|||Discontinue then switch|
1583772|NCT03975790|2912683|Superiority|||||||0.7824|||||||Chi-squared|||Switch immediately|
1583773|NCT03975790|2912683|Superiority|||||||0.9255|||||||Chi-squared|||Switch immediately|
1583774|NCT03975790|2912683|Superiority|||||||0.5944|||||||Chi-squared|||Switch immediately|
1583775|NCT03975790|2912684|Superiority|||||||0.0557|||||||Chi-squared||||
1583776|NCT03975790|2912684|Superiority|||||||0.0014|||||||Chi-squared||||
1583777|NCT03975790|2912684|Superiority|||||||0.2242|||||||Chi-squared||||
1583778|NCT03975790|2912685|Superiority|||||||0.2839|||||||Chi-squared|||Sleep disorders|
1583779|NCT03975790|2912685|Superiority|||||||0.1288|||||||Chi-squared|||Sleep disorders|
1583780|NCT03975790|2912685|Superiority|||||||0.785|||||||Chi-squared|||Sleep disorders|
1583781|NCT03975790|2912685|Superiority|||||||0.2074|||||||Chi-squared|||Liver disease|
1583782|NCT03975790|2912685|Superiority|||||||0.4371|||||||Chi-squared|||Liver disease|
1583783|NCT03975790|2912685|Superiority|||||||0.4184|||||||Chi-squared|||Liver disease|
1583784|NCT03975790|2912685|Superiority|||||||0.7824|||||||Chi-squared|||Anxiety|
1583785|NCT03975790|2912685|Superiority|||||||0.2228|||||||Chi-squared|||Anxiety|
1583786|NCT03975790|2912685|Superiority|||||||0.2596|||||||Chi-squared|||Anxiety|
1583787|NCT03975790|2912685|Superiority|||||||0.9641|||||||Chi-squared|||Depression|
1583788|NCT03975790|2912685|Superiority|||||||0.9146|||||||Chi-squared|||Depression|
1583789|NCT03975790|2912685|Superiority|||||||0.941|||||||Chi-squared|||Depression|
1583790|NCT03975790|2912685|Superiority|||||||0.9575|||||||Chi-squared|||Diabetes|
1583791|NCT03975790|2912685|Superiority|||||||0.9255|||||||Chi-squared|||Diabetes|
1583792|NCT03975790|2912685|Superiority|||||||0.9657|||||||Chi-squared|||Diabetes|
1583793|NCT03975790|2912685|Superiority|||||||0.82|||||||Chi-squared|||Kidney disease|
1583794|NCT03975790|2912685|Superiority|||||||0.7248|||||||Chi-squared|||Kidney disease|
1583795|NCT03975790|2912685|Superiority|||||||0.9148|||||||Chi-squared|||Kidney disease|
1583796|NCT03975790|2912685|Superiority|||||||0.9713|||||||Chi-squared|||Asthma|
1583797|NCT03975790|2912685|Superiority|||||||0.7483|||||||Chi-squared|||Asthma|
1583798|NCT03975790|2912685|Superiority|||||||8.33|||||||Chi-squared|||Asthma|
1583799|NCT03975790|2912685|Superiority|||||||0.8517|||||||Chi-squared|||COPD|
1583800|NCT03975790|2912685|Superiority|||||||0.5202|||||||Chi-squared|||COPD|
1583801|NCT03975790|2912685|Superiority|||||||0.5927|||||||Chi-squared|||COPD|
1583802|NCT03975790|2912685|Superiority|||||||0.8376|||||||Chi-squared|||Cardiovascular Disease|
1583803|NCT03975790|2912685|Superiority|||||||0.8021|||||||Chi-squared|||Cardiovascular Disease|
1583804|NCT03975790|2912685|Superiority|||||||0.9829|||||||Chi-squared|||Cardiovascular Disease|
1583805|NCT03975790|2912686|Superiority|||||||0.4519|||||||t-test|||RA related|
1583806|NCT03975790|2912686|Superiority|||||||0.4477|||||||t-test|||RA related|
1583807|NCT03975790|2912686|Superiority|||||||0.9439|||||||t-test|||RA related|
1583808|NCT03975790|2912686|Superiority|||||||0.153|||||||t-test|||All cause|
1583809|NCT03975790|2912686|Superiority|||||||0.439|||||||t-test|||All cause|
1583810|NCT03975790|2912686|Superiority|||||||0.293|||||||t-test|||All cause|
1583811|NCT03975790|2912687|Superiority|||||||0.0772|||||||t-test|||RA related|
1583812|NCT03975790|2912687|Superiority|||||||0.2812|||||||t-test|||RA related|
1583813|NCT03975790|2912687|Superiority|||||||0.2277|||||||t-test|||RA related|
1583814|NCT03975790|2912687|Superiority|||||||0.0041|||||||t-test|||All cause|
1583815|NCT03975790|2912687|Superiority|||||||0.4222|||||||t-test|||All cause|
1583816|NCT03975790|2912687|Superiority|||||||0.0056|||||||t-test|||All cause|
1583817|NCT03975790|2912688|Superiority|||||||0.3295|||||||t-test||||
1583818|NCT03975790|2912688|Superiority|||||||0.8744|||||||t-test||||
1583819|NCT03975790|2912688|Superiority|||||||0.1906|||||||t-test||||
1583820|NCT03975790|2912689|Superiority|||||||0.2764|||||||t-test||||
1583821|NCT03975790|2912689|Superiority|||||||0.0859|||||||t-test||||
1583822|NCT03975790|2912689|Superiority|||||||0.6908|||||||t-test||||
1583823|NCT03975790|2912690|Superiority|||||||0.5577|||||||t-test||||
1583824|NCT03975790|2912690|Superiority|||||||0.2375|||||||t-test||||
1583825|NCT03975790|2912690|Superiority|||||||0.5027|||||||t-test||||
1583826|NCT03975790|2912691|Superiority|||||||0.6496|||||||t-test||||
1583827|NCT03975790|2912691|Superiority|||||||0.6183|||||||t-test||||
1583828|NCT03975790|2912691|Superiority|||||||0.8899|||||||t-test||||
1583829|NCT03975790|2912692|Superiority|||||||0.1083|||||||t-test||||
1583830|NCT03975790|2912692|Superiority|||||||0.0467|||||||t-test||||
1583831|NCT03975790|2912692|Superiority|||||||0.8205|||||||t-test||||
1583832|NCT03975790|2912693|Superiority|||||||0.3388|||||||Chi-squared||||
1583833|NCT03975790|2912693|Superiority|||||||0.3025|||||||Chi-squared||||
1583834|NCT03975790|2912693|Superiority|||||||0.9379|||||||Chi-squared||||
1583835|NCT03975790|2912694|Superiority|||||||0.1406|||||||Chi-squared||||
1583836|NCT03975790|2912694|Superiority|||||||0.0095|||||||Chi-squared||||
1583837|NCT03975790|2912694|Superiority|||||||0.1344|||||||Chi-squared||||
1583838|NCT03975790|2912695|Superiority|||||||0.8337|||||||Chi-squared|||Post Persistency|
1583839|NCT03975790|2912695|Superiority|||||||0.7826|||||||Chi-squared|||Post Persistency|
1583840|NCT03975790|2912695|Superiority|||||||0.4876|||||||Chi-squared|||Post Persistency|
1583841|NCT03975790|2912695|Superiority|||||||0.6148|||||||Chi-squared|||During Persistency|
1583842|NCT03975790|2912695|Superiority|||||||0.7124|||||||Chi-squared|||During Persistency|
1583843|NCT03975790|2912695|Superiority|||||||0.7816|||||||Chi-squared|||During Persistency|
1583844|NCT03975790|2912696|Superiority|||||||0.8229|||||||Chi-squared|||Post Persistency|
1583845|NCT03975790|2912696|Superiority|||||||0.1344|||||||Chi-squared|||Post Persistency|
1583846|NCT03975790|2912696|Superiority|||||||0.1153|||||||Chi-squared|||Post Persistency|
1583847|NCT03975790|2912696|Superiority|||||||0.2809|||||||Chi-squared|||During Persistency|
1583848|NCT03975790|2912696|Superiority|||||||0.5247|||||||Chi-squared|||During Persistency|
1583849|NCT03975790|2912696|Superiority|||||||0.4261|||||||Chi-squared|||During Persistency|
1583850|NCT03975790|2912697|Superiority|||||||0.7827|||||||t-test||||
1583851|NCT03975790|2912697|Superiority|||||||0.2509|||||||t-test||||
1583852|NCT03975790|2912697|Superiority|||||||0.3076|||||||t-test||||
1583853|NCT03975790|2912698|Superiority|||||||0.4809|||||||t-test||||
1583854|NCT03975790|2912698|Superiority|||||||0.4806|||||||t-test||||
1583855|NCT03975790|2912698|Superiority|||||||0.8453|||||||t-test||||
1583856|NCT03975790|2912699|Superiority|||||||0.0358|||||||t-test||||
1583857|NCT03975790|2912699|Superiority|||||||0.007|||||||t-test||||
1583858|NCT03975790|2912699|Superiority|||||||0.8138|||||||t-test||||
1583859|NCT03975790|2912700|Superiority|||||||0.6962|||||||t-test||||
1583860|NCT03975790|2912700|Superiority|||||||0.2959|||||||t-test||||
1583861|NCT03975790|2912700|Superiority|||||||0.3292|||||||t-test||||
1583862|NCT03975790|2912701|Superiority|||||||0.3833|||||||t-test||||
1583863|NCT03975790|2912701|Superiority|||||||0.6356|||||||t-test||||
1583864|NCT03975790|2912701|Superiority|||||||0.3955|||||||t-test||||
1583865|NCT03975790|2912702|Superiority|||||||0.4201|||||||t-test||||
1583866|NCT03975790|2912702|Superiority|||||||0.1411|||||||t-test||||
1583867|NCT03975790|2912702|Superiority|||||||0.1461|||||||t-test||||
1583868|NCT03975790|2912703|Superiority|||||||0.4702|||||||Chi-squared||||
1583869|NCT03975790|2912703|Superiority|||||||0.5241|||||||Chi-squared||||
1583870|NCT03975790|2912703|Superiority|||||||0.7977|||||||Chi-squared||||
1583871|NCT03975790|2912704|Superiority|||||||0.3467|||||||Chi-squared||||
1583872|NCT03975790|2912704|Superiority|||||||0.3063|||||||Chi-squared||||
1583873|NCT03975790|2912704|Superiority|||||||0.9392|||||||Chi-squared||||
1583874|NCT03975790|2912705|Superiority|||||||0.7293|||||||Chi-squared||||
1583875|NCT03975790|2912705|Superiority|||||||0.6283|||||||Chi-squared||||
1583876|NCT03975790|2912705|Superiority|||||||0.9085|||||||Chi-squared||||
1583877|NCT03975790|2912706|Superiority|||||||0.7964|||||||Chi-squared||||
1583878|NCT03975790|2912706|Superiority|||||||0.5237|||||||Chi-squared||||
1583879|NCT03975790|2912706|Superiority|||||||0.2178|||||||Chi-squared||||
1583880|NCT03975790|2912707|Superiority|||||||0.9481|||||||Chi-squared|||Ibuprofen|
1583881|NCT03975790|2912707|Superiority|||||||0.1515|||||||Chi-squared|||Ibuprofen|
1583882|NCT03975790|2912707|Superiority|||||||0.0489|||||||Chi-squared|||Ibuprofen|
1583883|NCT03975790|2912707|Superiority|||||||0.3104|||||||Chi-squared|||Cephalexin|
1583884|NCT03975790|2912707|Superiority|||||||0.9549|||||||Chi-squared|||Cephalexin|
1583885|NCT03975790|2912707|Superiority|||||||0.166|||||||Chi-squared|||Cephalexin|
1583886|NCT03975790|2912707|Superiority|||||||0.9451|||||||Chi-squared|||Levofloxacin|
1583887|NCT03975790|2912707|Superiority|||||||0.8121|||||||Chi-squared|||Levofloxacin|
1583888|NCT03975790|2912707|Superiority|||||||0.6744|||||||Chi-squared|||Levofloxacin|
1583889|NCT03975790|2912707|Superiority|||||||0.3109|||||||Chi-squared|||Diclofenac Sodium|
1583890|NCT03975790|2912707|Superiority|||||||0.9702|||||||Chi-squared|||Diclofenac Sodium|
1583891|NCT03975790|2912707|Superiority|||||||0.1174|||||||Chi-squared|||Diclofenac Sodium|
1583892|NCT03975790|2912707|Superiority|||||||0.2871|||||||Chi-squared|||Duloxetine Hydrochloride|
1583893|NCT03975790|2912707|Superiority|||||||0.8251|||||||Chi-squared|||Duloxetine Hydrochloride|
1583894|NCT03975790|2912707|Superiority|||||||0.041|||||||Chi-squared|||Duloxetine Hydrochloride|
1583895|NCT03975790|2912707|Superiority|||||||0.5425|||||||Chi-squared|||Ciprofloxacin Hydrochloride|
1583896|NCT03975790|2912707|Superiority|||||||0.6355|||||||Chi-squared|||Ciprofloxacin Hydrochloride|
1583897|NCT03975790|2912707|Superiority|||||||0.7637|||||||Chi-squared|||Ciprofloxacin Hydrochloride|
1583898|NCT03975790|2912707|Superiority|||||||0.8421|||||||Chi-squared|||Fluticasone Propionate|
1583899|NCT03975790|2912707|Superiority|||||||0.7131|||||||Chi-squared|||Fluticasone Propionate|
1583900|NCT03975790|2912707|Superiority|||||||0.8578|||||||Chi-squared|||Fluticasone Propionate|
1583901|NCT03975790|2912707|Superiority|||||||0.214|||||||Chi-squared|||Cyclobenzaprine Hydrochloride|
1583902|NCT03975790|2912707|Superiority|||||||0.7961|||||||Chi-squared|||Cyclobenzaprine Hydrochloride|
1583903|NCT03975790|2912707|Superiority|||||||0.1046|||||||Chi-squared|||Cyclobenzaprine Hydrochloride|
1583904|NCT03975790|2912707|Superiority|||||||0.2973|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium|
1583905|NCT03975790|2912707|Superiority|||||||0.8542|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium|
1583906|NCT03975790|2912707|Superiority|||||||0.1984|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium|
1583907|NCT03975790|2912707|Superiority|||||||0.9358|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride|
1583908|NCT03975790|2912707|Superiority|||||||0.2588|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride|
1583909|NCT03975790|2912707|Superiority|||||||0.1079|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride|
1583910|NCT03975790|2912707|Superiority|||||||0.938|||||||Chi-squared|||Gabapentin|
1583911|NCT03975790|2912707|Superiority|||||||0.9719|||||||Chi-squared|||Gabapentin|
1583912|NCT03975790|2912707|Superiority|||||||0.8697|||||||Chi-squared|||Gabapentin|
1583913|NCT03975790|2912707|Superiority|||||||0.1851|||||||Chi-squared|||Albuterol Sulfate|
1583914|NCT03975790|2912707|Superiority|||||||0.1253|||||||Chi-squared|||Albuterol Sulfate|
1583915|NCT03975790|2912707|Superiority|||||||0.9373|||||||Chi-squared|||Albuterol Sulfate|
1583916|NCT03975790|2912707|Superiority|||||||0.8576|||||||Chi-squared|||Amoxicillin|
1583917|NCT03975790|2912707|Superiority|||||||0.9896|||||||Chi-squared|||Amoxicillin|
1583918|NCT03975790|2912707|Superiority|||||||0.7993|||||||Chi-squared|||Amoxicillin|
1583919|NCT03975790|2912707|Superiority|||||||0.451|||||||Chi-squared|||Meloxicam|
1583920|NCT03975790|2912707|Superiority|||||||0.2667|||||||Chi-squared|||Meloxicam|
1583921|NCT03975790|2912707|Superiority|||||||0.7183|||||||Chi-squared|||Meloxicam|
1583922|NCT03975790|2912707|Superiority|||||||0.4837|||||||Chi-squared|||Tramadol Hydrochloride|
1583923|NCT03975790|2912707|Superiority|||||||0.3239|||||||Chi-squared|||Tramadol Hydrochloride|
1583924|NCT03975790|2912707|Superiority|||||||0.0162|||||||Chi-squared|||Tramadol Hydrochloride|
1583925|NCT03975790|2912707|Superiority|||||||0.4384|||||||Chi-squared|||Omeprazole|
1584266|NCT03882047|2912919|Other|||||||0.53|||||||ANOVA||||
1583926|NCT03975790|2912707|Superiority|||||||0.9212|||||||Chi-squared|||Omeprazole|
1583927|NCT03975790|2912707|Superiority|||||||0.9212|||||||Chi-squared|||Omeprazole|
1583928|NCT03975790|2912707|Superiority|||||||0.992|||||||Chi-squared|||Methylprednisolone|
1583929|NCT03975790|2912707|Superiority|||||||0.2117|||||||Chi-squared|||Methylprednisolone|
1583930|NCT03975790|2912707|Superiority|||||||0.1033|||||||Chi-squared|||Methylprednisolone|
1583931|NCT03975790|2912707|Superiority|||||||0.5785|||||||Chi-squared|||Levothyroxine Sodium|
1583932|NCT03975790|2912707|Superiority|||||||0.5948|||||||Chi-squared|||Levothyroxine Sodium|
1583933|NCT03975790|2912707|Superiority|||||||0.1348|||||||Chi-squared|||Levothyroxine Sodium|
1583934|NCT03975790|2912707|Superiority|||||||0.4146|||||||Chi-squared|||Etanercept|
1583935|NCT03975790|2912707|Superiority|||||||0.7644|||||||Chi-squared|||Etanercept|
1583936|NCT03975790|2912707|Superiority|||||||0.408|||||||Chi-squared|||Etanercept|
1583937|NCT03975790|2912707|Superiority|||||||0.9505|||||||Chi-squared|||Hydroxychloroquine Sulfate|
1583938|NCT03975790|2912707|Superiority|||||||0.4882|||||||Chi-squared|||Hydroxychloroquine Sulfate|
1583939|NCT03975790|2912707|Superiority|||||||0.3116|||||||Chi-squared|||Hydroxychloroquine Sulfate|
1583940|NCT03975790|2912707|Superiority|||||||0.05|||||||Chi-squared|||Adalimumab|
1583941|NCT03975790|2912707|Superiority|||||||0.0501|||||||Chi-squared|||Adalimumab|
1583942|NCT03975790|2912707|Superiority|||||||0.7272|||||||Chi-squared|||Adalimumab|
1583943|NCT03975790|2912707|Superiority|||||||0.8143|||||||Chi-squared|||Azithromycin|
1583944|NCT03975790|2912707|Superiority|||||||0.385|||||||Chi-squared|||Azithromycin|
1583945|NCT03975790|2912707|Superiority|||||||0.4291|||||||Chi-squared|||Azithromycin|
1583946|NCT03975790|2912707|Superiority|||||||0.1165|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate|
1583947|NCT03975790|2912707|Superiority|||||||0.385|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate|
1583948|NCT03975790|2912707|Superiority|||||||0.2198|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate|
1583949|NCT03975790|2912707|Superiority|||||||0.5631|||||||Chi-squared|||Prednisone|
1583950|NCT03975790|2912707|Superiority|||||||0.049|||||||Chi-squared|||Prednisone|
1583951|NCT03975790|2912707|Superiority|||||||0.0571|||||||Chi-squared|||Prednisone|
1583952|NCT03975790|2912707|Superiority|||||||0.942|||||||Chi-squared|||Folic Acid|
1583953|NCT03975790|2912707|Superiority|||||||0.7131|||||||Chi-squared|||Folic Acid|
1583954|NCT03975790|2912707|Superiority|||||||0.55|||||||Chi-squared|||Folic Acid|
1583955|NCT03975790|2912707|Superiority|||||||0.3956|||||||Chi-squared|||MTX Sodium|
1583956|NCT03975790|2912707|Superiority|||||||0.2349|||||||Chi-squared|||MTX Sodium|
1583957|NCT03975790|2912708|Superiority|||||||0.3399|||||||Chi-squared|||Levofloxacin|
1583958|NCT03975790|2912708|Superiority|||||||0.4713|||||||Chi-squared|||Levofloxacin|
1583959|NCT03975790|2912708|Superiority|||||||0.6088|||||||Chi-squared|||Levofloxacin|
1583960|NCT03975790|2912708|Superiority|||||||0.1592|||||||Chi-squared|||Diclofenac Sodium|
1583961|NCT03975790|2912708|Superiority|||||||0.505|||||||Chi-squared|||Diclofenac Sodium|
1583962|NCT03975790|2912708|Superiority|||||||0.1615|||||||Chi-squared|||Diclofenac Sodium|
1583963|NCT03975790|2912708|Superiority|||||||0.6254|||||||Chi-squared|||Atorvastatin Calcium|
1583964|NCT03975790|2912708|Superiority|||||||0.7703|||||||Chi-squared|||Atorvastatin Calcium|
1583965|NCT03975790|2912708|Superiority|||||||0.7279|||||||Chi-squared|||Atorvastatin Calcium|
1583966|NCT03975790|2912708|Superiority|||||||0.1215|||||||Chi-squared|||Duloxetine Hydrochloride|
1583967|NCT03975790|2912708|Superiority|||||||0.4092|||||||Chi-squared|||Duloxetine Hydrochloride|
1583968|NCT03975790|2912708|Superiority|||||||0.1608|||||||Chi-squared|||Duloxetine Hydrochloride|
1583969|NCT03975790|2912708|Superiority|||||||0.3071|||||||Chi-squared|||Ciprofloxacin Hydrochloride|
1583970|NCT03975790|2912708|Superiority|||||||0.5734|||||||Chi-squared|||Ciprofloxacin Hydrochloride|
1583971|NCT03975790|2912708|Superiority|||||||0.4426|||||||Chi-squared|||Ciprofloxacin Hydrochloride|
1583972|NCT03975790|2912708|Superiority|||||||0.5631|||||||Chi-squared|||Fluticasone Propionate|
1583973|NCT03975790|2912708|Superiority|||||||0.5032|||||||Chi-squared|||Fluticasone Propionate|
1583974|NCT03975790|2912708|Superiority|||||||0.9769|||||||Chi-squared|||Fluticasone Propionate|
1583975|NCT03975790|2912708|Superiority|||||||0.7091|||||||Chi-squared|||Cyclobenzaprine Hydrochloride|
1583976|NCT03975790|2912708|Superiority|||||||0.8155|||||||Chi-squared|||Cyclobenzaprine Hydrochloride|
1583977|NCT03975790|2912708|Superiority|||||||0.367|||||||Chi-squared|||Cyclobenzaprine Hydrochloride|
1583978|NCT03975790|2912708|Superiority|||||||0.8898|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium|
1583979|NCT03975790|2912708|Superiority|||||||0.5615|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium|
1583980|NCT03975790|2912708|Superiority|||||||0.3319|||||||Chi-squared|||Amoxicillin/Clavulanate Potassium|
1583981|NCT03975790|2912708|Superiority|||||||0.3363|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride|
1583982|NCT03975790|2912708|Superiority|||||||0.8606|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride|
1583983|NCT03975790|2912708|Superiority|||||||0.0694|||||||Chi-squared|||Acetaminophen/Oxycodone Hydrochloride|
1583984|NCT03975790|2912708|Superiority|||||||0.8305|||||||Chi-squared|||Gabapentin|
1583985|NCT03975790|2912708|Superiority|||||||0.8789|||||||Chi-squared|||Gabapentin|
1583986|NCT03975790|2912708|Superiority|||||||0.9007|||||||Chi-squared|||Gabapentin|
1583987|NCT03975790|2912708|Superiority|||||||0.1215|||||||Chi-squared|||Albuterol Sulfate|
1583988|NCT03975790|2912708|Superiority|||||||0.1175|||||||Chi-squared|||Albuterol Sulfate|
1583989|NCT03975790|2912708|Superiority|||||||0.8433|||||||Chi-squared|||Albuterol Sulfate|
1583990|NCT03975790|2912708|Superiority|||||||0.9228|||||||Chi-squared|||Amoxicillin|
1583991|NCT03975790|2912708|Superiority|||||||0.6329|||||||Chi-squared|||Amoxicillin|
1583992|NCT03975790|2912708|Superiority|||||||0.6338|||||||Chi-squared|||Amoxicillin|
1583993|NCT03975790|2912708|Superiority|||||||0.5137|||||||Chi-squared|||Meloxicam|
1583994|NCT03975790|2912708|Superiority|||||||0.9255|||||||Chi-squared|||Meloxicam|
1583995|NCT03975790|2912708|Superiority|||||||0.3653|||||||Chi-squared|||Meloxicam|
1583996|NCT03975790|2912708|Superiority|||||||0.9481|||||||Chi-squared|||Tramadol Hydrochloride|
1583997|NCT03975790|2912708|Superiority|||||||0.3633|||||||Chi-squared|||Tramadol Hydrochloride|
1583998|NCT03975790|2912708|Superiority|||||||0.1956|||||||Chi-squared|||Tramadol Hydrochloride|
1583999|NCT03975790|2912708|Superiority|||||||0.9541|||||||Chi-squared|||Omeprazole|
1584000|NCT03975790|2912708|Superiority|||||||0.5785|||||||Chi-squared|||Omeprazole|
1584001|NCT03975790|2912708|Superiority|||||||0.4568|||||||Chi-squared|||Omeprazole|
1584002|NCT03975790|2912708|Superiority|||||||0.3137|||||||Chi-squared|||Methylprednisolone|
1584003|NCT03975790|2912708|Superiority|||||||0.0636|||||||Chi-squared|||Methylprednisolone|
1584004|NCT03975790|2912708|Superiority|||||||0.4166|||||||Chi-squared|||Methylprednisolone|
1584005|NCT03975790|2912708|Superiority|||||||0.5785|||||||Chi-squared|||Levothyroxine Sodium|
1584006|NCT03975790|2912708|Superiority|||||||0.6563|||||||Chi-squared|||Levothyroxine Sodium|
1584007|NCT03975790|2912708|Superiority|||||||0.1663|||||||Chi-squared|||Levothyroxine Sodium|
1584008|NCT03975790|2912708|Superiority|||||||0.158|||||||Chi-squared|||Etanercept|
1584009|NCT03975790|2912708|Superiority|||||||0.1013|||||||Chi-squared|||Etanercept|
1584010|NCT03975790|2912708|Superiority|||||||0.9654|||||||Chi-squared|||Etanercept|
1584011|NCT03975790|2912708|Superiority|||||||0.8371|||||||Chi-squared|||Hydroxychloroquine Sulfate|
1584012|NCT03975790|2912708|Superiority|||||||0.5654|||||||Chi-squared|||Hydroxychloroquine Sulfate|
1584013|NCT03975790|2912708|Superiority|||||||0.6465|||||||Chi-squared|||Hydroxychloroquine Sulfate|
1584014|NCT03975790|2912708|Superiority|||||||0.0408|||||||Chi-squared|||Adalimumab|
1584015|NCT03975790|2912708|Superiority|||||||0.057|||||||Chi-squared|||Adalimumab|
1584016|NCT03975790|2912708|Superiority|||||||0.5909|||||||Chi-squared|||Adalimumab|
1584017|NCT03975790|2912708|Superiority|||||||0.8576|||||||Chi-squared|||Azithromycin|
1584018|NCT03975790|2912708|Superiority|||||||0.2588|||||||Chi-squared|||Azithromycin|
1584019|NCT03975790|2912708|Superiority|||||||0.2315|||||||Chi-squared|||Azithromycin|
1584020|NCT03975790|2912708|Superiority|||||||0.4768|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate|
1584021|NCT03975790|2912708|Superiority|||||||0.6017|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate|
1584022|NCT03975790|2912708|Superiority|||||||0.6934|||||||Chi-squared|||Acetaminophen/Hydrocodone Bitartrate|
1584023|NCT03975790|2912708|Superiority|||||||0.5348|||||||Chi-squared|||Prednisone|
1584024|NCT03975790|2912708|Superiority|||||||0.0327|||||||Chi-squared|||Prednisone|
1584025|NCT03975790|2912708|Superiority|||||||0.0473|||||||Chi-squared|||Prednisone|
1584026|NCT03975790|2912708|Superiority|||||||0.8363|||||||Chi-squared|||Folic Acid|
1584027|NCT03975790|2912708|Superiority|||||||0.8542|||||||Chi-squared|||Folic Acid|
1584028|NCT03975790|2912708|Superiority|||||||0.5744|||||||Chi-squared|||Folic Acid|
1584029|NCT03975790|2912708|Superiority|||||||0.9861|||||||Chi-squared|||MTX Sodium|
1584030|NCT03975790|2912708|Superiority|||||||0.9978|||||||Chi-squared|||MTX Sodium|
1584031|NCT03975790|2912708|Superiority|||||||0.9758|||||||Chi-squared|||MTX Sodium|
1584032|NCT03975790|2912709|Superiority|||||||0.0691|||||||t-test||||
1584033|NCT03975790|2912709|Superiority|||||||0.2109|||||||t-test||||
1584034|NCT03975790|2912709|Superiority|||||||0.2336|||||||t-test||||
1584035|NCT03975790|2912710|Superiority|||||||0.4992|||||||Chi-squared|||Other upper respiratory disease|
1584036|NCT03975790|2912710|Superiority|||||||0.3835|||||||Chi-squared|||Other upper respiratory disease|
1584037|NCT03975790|2912710|Superiority|||||||0.8746|||||||Chi-squared|||Other upper respiratory disease|
1584038|NCT03975790|2912710|Superiority|||||||0.7089|||||||Chi-squared|||Other/unspecified benign neoplasm|
1584039|NCT03975790|2912710|Superiority|||||||0.3928|||||||Chi-squared|||Other/unspecified benign neoplasm|
1584040|NCT03975790|2912710|Superiority|||||||0.5935|||||||Chi-squared|||Other/unspecified benign neoplasm|
1584041|NCT03975790|2912710|Superiority|||||||0.7323|||||||Chi-squared|||Diabetes mellitus without complication|
1584042|NCT03975790|2912710|Superiority|||||||0.7698|||||||Chi-squared|||Diabetes mellitus without complication|
1584043|NCT03975790|2912710|Superiority|||||||0.3559|||||||Chi-squared|||Diabetes mellitus without complication|
1584044|NCT03975790|2912710|Superiority|||||||0.7454|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders|
1584045|NCT03975790|2912710|Superiority|||||||0.8118|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders|
1584046|NCT03975790|2912710|Superiority|||||||0.4246|||||||Chi-squared|||Other nutritional: endocrine/metabolic disorders|
1584047|NCT03975790|2912710|Superiority|||||||0.402|||||||Chi-squared|||Nutritional deficiencies|
1584048|NCT03975790|2912710|Superiority|||||||0.0815|||||||Chi-squared|||Nutritional deficiencies|
1584049|NCT03975790|2912710|Superiority|||||||0.3446|||||||Chi-squared|||Nutritional deficiencies|
1584050|NCT03975790|2912710|Superiority|||||||0.7089|||||||Chi-squared|||Esophageal disorders|
1584051|NCT03975790|2912710|Superiority|||||||0.7698|||||||Chi-squared|||Esophageal disorders|
1584052|NCT03975790|2912710|Superiority|||||||0.8568|||||||Chi-squared|||Esophageal disorders|
1584053|NCT03975790|2912710|Superiority|||||||0.5984|||||||Chi-squared|||Malaise/fatigue|
1584054|NCT03975790|2912710|Superiority|||||||0.3374|||||||Chi-squared|||Malaise/fatigue|
1584055|NCT03975790|2912710|Superiority|||||||0.6082|||||||Chi-squared|||Malaise/fatigue|
1584056|NCT03975790|2912710|Superiority|||||||0.4384|||||||Chi-squared|||Other bone disease/musculoskeletal deformities|
1584057|NCT03975790|2912710|Superiority|||||||0.956|||||||Chi-squared|||Other bone disease/musculoskeletal deformities|
1584058|NCT03975790|2912710|Superiority|||||||0.2857|||||||Chi-squared|||Other bone disease/musculoskeletal deformities|
1584059|NCT03975790|2912710|Superiority|||||||0.8376|||||||Chi-squared|||Thyroid disorders|
1584060|NCT03975790|2912710|Superiority|||||||0.5766|||||||Chi-squared|||Thyroid disorders|
1584061|NCT03975790|2912710|Superiority|||||||0.6626|||||||Chi-squared|||Thyroid disorders|
1584062|NCT03975790|2912710|Superiority|||||||0.6749|||||||Chi-squared|||Other skin disorders|
1584063|NCT03975790|2912710|Superiority|||||||0.4183|||||||Chi-squared|||Other skin disorders|
1584064|NCT03975790|2912710|Superiority|||||||0.6755|||||||Chi-squared|||Other skin disorders|
1584065|NCT03975790|2912710|Superiority|||||||0.791|||||||Chi-squared|||Other nervous system disorders|
1584066|NCT03975790|2912710|Superiority|||||||0.0933|||||||Chi-squared|||Other nervous system disorders|
1584067|NCT03975790|2912710|Superiority|||||||0.0745|||||||Chi-squared|||Other nervous system disorders|
1584068|NCT03975790|2912710|Superiority|||||||0.1569|||||||Chi-squared|||Other lower respiratory disease|
1584069|NCT03975790|2912710|Superiority|||||||0.1583|||||||Chi-squared|||Other lower respiratory disease|
1584070|NCT03975790|2912710|Superiority|||||||0.7575|||||||Chi-squared|||Other lower respiratory disease|
1584071|NCT03975790|2912710|Superiority|||||||0.1279|||||||Chi-squared|||Other upper respiratory infections|
1584072|NCT03975790|2912710|Superiority|||||||0.3313|||||||Chi-squared|||Other upper respiratory infections|
1584073|NCT03975790|2912710|Superiority|||||||0.3109|||||||Chi-squared|||Other upper respiratory infections|
1584074|NCT03975790|2912710|Superiority|||||||0.1859|||||||Chi-squared|||Back problems|
1584075|NCT03975790|2912710|Superiority|||||||0.1441|||||||Chi-squared|||Back problems|
1584076|NCT03975790|2912710|Superiority|||||||0.9272|||||||Chi-squared|||Back problems|
1584077|NCT03975790|2912710|Superiority|||||||0.7319|||||||Chi-squared|||Disorders of lipid metabolism|
1584078|NCT03975790|2912710|Superiority|||||||0.5732|||||||Chi-squared|||Disorders of lipid metabolism|
1584079|NCT03975790|2912710|Superiority|||||||0.8212|||||||Chi-squared|||Disorders of lipid metabolism|
1584080|NCT03975790|2912710|Superiority|||||||0.7143|||||||Chi-squared|||Residual codes; unclassified|
1584081|NCT03975790|2912710|Superiority|||||||0.8922|||||||Chi-squared|||Residual codes; unclassified|
1584082|NCT03975790|2912710|Superiority|||||||0.4626|||||||Chi-squared|||Residual codes; unclassified|
1584083|NCT03975790|2912710|Superiority|||||||0.992|||||||Chi-squared|||Essential hypertension|
1584084|NCT03975790|2912710|Superiority|||||||0.3065|||||||Chi-squared|||Essential hypertension|
1584085|NCT03975790|2912710|Superiority|||||||0.1717|||||||Chi-squared|||Essential hypertension|
1584086|NCT03975790|2912710|Superiority|||||||0.9879|||||||Chi-squared|||Osteoarthritis|
1584087|NCT03975790|2912710|Superiority|||||||0.802|||||||Chi-squared|||Osteoarthritis|
1584088|NCT03975790|2912710|Superiority|||||||0.7577|||||||Chi-squared|||Osteoarthritis|
1584089|NCT03975790|2912710|Superiority|||||||0.0751|||||||Chi-squared|||Immunizations/screening for infectious disease|
1584090|NCT03975790|2912710|Superiority|||||||0.151|||||||Chi-squared|||Immunizations/screening for infectious disease|
1584091|NCT03975790|2912710|Superiority|||||||0.4187|||||||Chi-squared|||Immunizations/screening for infectious disease|
1584092|NCT03975790|2912710|Superiority|||||||0.9796|||||||Chi-squared|||Other suspected conditions|
1584093|NCT03975790|2912710|Superiority|||||||0.4953|||||||Chi-squared|||Other suspected conditions|
1584094|NCT03975790|2912710|Superiority|||||||0.3465|||||||Chi-squared|||Other suspected conditions|
1584095|NCT03975790|2912710|Superiority|||||||0.3422|||||||Chi-squared|||Medical examination/evaluation|
1584096|NCT03975790|2912710|Superiority|||||||0.8717|||||||Chi-squared|||Medical examination/evaluation|
1584097|NCT03975790|2912710|Superiority|||||||0.8717|||||||Chi-squared|||Medical examination/evaluation|
1584098|NCT03975790|2912710|Superiority|||||||0.6453|||||||Chi-squared|||Other non-traumatic joint disorders|
1584099|NCT03975790|2912710|Superiority|||||||0.183|||||||Chi-squared|||Other non-traumatic joint disorders|
1584100|NCT03975790|2912710|Superiority|||||||0.2848|||||||Chi-squared|||Other non-traumatic joint disorders|
1584101|NCT03975790|2912710|Superiority|||||||0.2876|||||||Chi-squared|||Other connective tissue disease|
1584102|NCT03975790|2912710|Superiority|||||||0.1435|||||||Chi-squared|||Other connective tissue disease|
1584103|NCT03975790|2912710|Superiority|||||||0.7354|||||||Chi-squared|||Other connective tissue disease|
1584104|NCT03975790|2912710|Superiority|||||||0.3|||||||Chi-squared|||Other aftercare|
1584105|NCT03975790|2912710|Superiority|||||||0.3772|||||||Chi-squared|||Other aftercare|
1584106|NCT03975790|2912710|Superiority|||||||0.0036|||||||Chi-squared|||Other aftercare|
1584107|NCT03975790|2912710|Superiority|||||||0.3088|||||||Chi-squared|||Rheumatoid arthritis/related disease|
1584108|NCT03975790|2912710|Superiority|||||||0.7055|||||||Chi-squared|||Rheumatoid arthritis/related disease|
1584109|NCT03975790|2912710|Superiority|||||||0.059|||||||Chi-squared|||Rheumatoid arthritis/related disease|
1584110|NCT03975790|2912711|Superiority|||||||0.342|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions|
1584111|NCT03975790|2912711|Superiority|||||||0.8327|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions|
1584112|NCT03975790|2912711|Superiority|||||||0.2731|||||||Chi-squared|||Genitourinary symptoms/ill-defined conditions|
1584113|NCT03975790|2912711|Superiority|||||||0.1815|||||||Chi-squared|||Other/unspecified benign neoplasm|
1584114|NCT03975790|2912711|Superiority|||||||0.136|||||||Chi-squared|||Other/unspecified benign neoplasm|
1584115|NCT03975790|2912711|Superiority|||||||0.9759|||||||Chi-squared|||Other/unspecified benign neoplasm|
1584116|NCT03975790|2912711|Superiority|||||||0.5983|||||||Chi-squared|||Diabetes mellitus without complication|
1584117|NCT03975790|2912711|Superiority|||||||0.8068|||||||Chi-squared|||Diabetes mellitus without complication|
1584118|NCT03975790|2912711|Superiority|||||||0.6402|||||||Chi-squared|||Diabetes mellitus without complication|
1584119|NCT03975790|2912711|Superiority|||||||0.3336|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders|
1584120|NCT03975790|2912711|Superiority|||||||0.636|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders|
1584121|NCT03975790|2912711|Superiority|||||||0.4158|||||||Chi-squared|||Other nutritional; endocrine; and metabolic disorders|
1584122|NCT03975790|2912711|Superiority|||||||0.8331|||||||Chi-squared|||Nutritional deficiencies|
1584123|NCT03975790|2912711|Superiority|||||||0.6705|||||||Chi-squared|||Nutritional deficiencies|
1584124|NCT03975790|2912711|Superiority|||||||0.8135|||||||Chi-squared|||Nutritional deficiencies|
1584125|NCT03975790|2912711|Superiority|||||||0.9445|||||||Chi-squared|||Esophageal disorders|
1584126|NCT03975790|2912711|Superiority|||||||0.636|||||||Chi-squared|||Esophageal disorders|
1584127|NCT03975790|2912711|Superiority|||||||0.6064|||||||Chi-squared|||Esophageal disorders|
1584128|NCT03975790|2912711|Superiority|||||||0.62|||||||Chi-squared|||Malaise/fatigue|
1584129|NCT03975790|2912711|Superiority|||||||0.4182|||||||Chi-squared|||Malaise/fatigue|
1584130|NCT03975790|2912711|Superiority|||||||0.7324|||||||Chi-squared|||Malaise/fatigue|
1584131|NCT03975790|2912711|Superiority|||||||0.7349|||||||Chi-squared|||Other bone disease/musculoskeletal deformities|
1584132|NCT03975790|2912711|Superiority|||||||0.8693|||||||Chi-squared|||Other bone disease/musculoskeletal deformities|
1584133|NCT03975790|2912711|Superiority|||||||0.7637|||||||Chi-squared|||Other bone disease/musculoskeletal deformities|
1584134|NCT03975790|2912711|Superiority|||||||0.3654|||||||Chi-squared|||Thyroid disorders|
1584135|NCT03975790|2912711|Superiority|||||||0.1682|||||||Chi-squared|||Thyroid disorders|
1584136|NCT03975790|2912711|Superiority|||||||0.6103|||||||Chi-squared|||Thyroid disorders|
1584137|NCT03975790|2912711|Superiority|||||||0.0278|||||||Chi-squared|||Other skin disorders|
1584138|NCT03975790|2912711|Superiority|||||||0.5172|||||||Chi-squared|||Other skin disorders|
1584139|NCT03975790|2912711|Superiority|||||||0.0219|||||||Chi-squared|||Other skin disorders|
1584140|NCT03975790|2912711|Superiority|||||||0.4768|||||||Chi-squared|||Other nervous system disorders|
1584141|NCT03975790|2912711|Superiority|||||||0.9901|||||||Chi-squared|||Other nervous system disorders|
1584142|NCT03975790|2912711|Superiority|||||||0.2613|||||||Chi-squared|||Other nervous system disorders|
1584143|NCT03975790|2912711|Superiority|||||||0.5057|||||||Chi-squared|||Other lower respiratory disease|
1584144|NCT03975790|2912711|Superiority|||||||0.2909|||||||Chi-squared|||Other lower respiratory disease|
1584145|NCT03975790|2912711|Superiority|||||||0.717|||||||Chi-squared|||Other lower respiratory disease|
1584146|NCT03975790|2912711|Superiority|||||||0.4724|||||||Chi-squared|||Other upper respiratory infections|
1584147|NCT03975790|2912711|Superiority|||||||0.3525|||||||Chi-squared|||Other upper respiratory infections|
1584148|NCT03975790|2912711|Superiority|||||||0.8775|||||||Chi-squared|||Other upper respiratory infections|
1584149|NCT03975790|2912711|Superiority|||||||0.4094|||||||Chi-squared|||Back problems|
1584150|NCT03975790|2912711|Superiority|||||||0.4427|||||||Chi-squared|||Back problems|
1584151|NCT03975790|2912711|Superiority|||||||0.0225|||||||Chi-squared|||Back problems|
1584152|NCT03975790|2912711|Superiority|||||||0.3875|||||||Chi-squared|||Disorders of lipid metabolism|
1584153|NCT03975790|2912711|Superiority|||||||0.7725|||||||Chi-squared|||Disorders of lipid metabolism|
1584154|NCT03975790|2912711|Superiority|||||||0.3559|||||||Chi-squared|||Disorders of lipid metabolism|
1584155|NCT03975790|2912711|Superiority|||||||0.7143|||||||Chi-squared|||Residual codes; unclassified|
1584156|NCT03975790|2912711|Superiority|||||||0.4975|||||||Chi-squared|||Residual codes; unclassified|
1584157|NCT03975790|2912711|Superiority|||||||0.7356|||||||Chi-squared|||Residual codes; unclassified|
1584158|NCT03975790|2912711|Superiority|||||||0.2871|||||||Chi-squared|||Essential hypertension|
1584159|NCT03975790|2912711|Superiority|||||||0.0778|||||||Chi-squared|||Essential hypertension|
1584160|NCT03975790|2912711|Superiority|||||||0.4808|||||||Chi-squared|||Essential hypertension|
1584161|NCT03975790|2912711|Superiority|||||||0.0318|||||||Chi-squared|||Osteoarthritis|
1584162|NCT03975790|2912711|Superiority|||||||0.1009|||||||Chi-squared|||Osteoarthritis|
1584163|NCT03975790|2912711|Superiority|||||||0.2742|||||||Chi-squared|||Osteoarthritis|
1584164|NCT03975790|2912711|Superiority|||||||0.4123|||||||Chi-squared|||Immunizations/screening for infectious disease|
1584165|NCT03975790|2912711|Superiority|||||||0.1012|||||||Chi-squared|||Immunizations/screening for infectious disease|
1584166|NCT03975790|2912711|Superiority|||||||0.3529|||||||Chi-squared|||Immunizations/screening for infectious disease|
1584167|NCT03975790|2912711|Superiority|||||||0.3449|||||||Chi-squared|||Other suspected conditions|
1584168|NCT03975790|2912711|Superiority|||||||0.2243|||||||Chi-squared|||Other suspected conditions|
1584169|NCT03975790|2912711|Superiority|||||||0.8652|||||||Chi-squared|||Other suspected conditions|
1584170|NCT03975790|2912711|Superiority|||||||0.2765|||||||Chi-squared|||Medical examination/evaluation|
1584171|NCT03975790|2912711|Superiority|||||||0.3034|||||||Chi-squared|||Medical examination/evaluation|
1584172|NCT03975790|2912711|Superiority|||||||0.7661|||||||Chi-squared|||Medical examination/evaluation|
1584173|NCT03975790|2912711|Superiority|||||||0.9228|||||||Chi-squared|||Other non-traumatic joint disorders|
1584174|NCT03975790|2912711|Superiority|||||||0.8877|||||||Chi-squared|||Other non-traumatic joint disorders|
1584175|NCT03975790|2912711|Superiority|||||||0.9683|||||||Chi-squared|||Other non-traumatic joint disorders|
1584176|NCT03975790|2912711|Superiority|||||||0.0583|||||||Chi-squared|||Other connective tissue disease|
1584177|NCT03975790|2912711|Superiority|||||||0.4228|||||||Chi-squared|||Other connective tissue disease|
1584178|NCT03975790|2912711|Superiority|||||||0.0774|||||||Chi-squared|||Other connective tissue disease|
1584179|NCT03975790|2912711|Superiority|||||||0.7349|||||||Chi-squared|||Other aftercare|
1584180|NCT03975790|2912711|Superiority|||||||0.2316|||||||Chi-squared|||Other aftercare|
1584181|NCT03975790|2912711|Superiority|||||||0.0345|||||||Chi-squared|||Other aftercare|
1584182|NCT03975790|2912712|Superiority|||||||0.5375|||||||t-test||||
1584183|NCT03975790|2912712|Superiority|||||||0.348|||||||t-test||||
1584184|NCT03975790|2912712|Superiority|||||||0.6033|||||||t-test||||
1584185|NCT03975790|2912713|Superiority|||||||0.4309|||||||t-test||||
1584186|NCT03975790|2912713|Superiority|||||||0.9851|||||||t-test||||
1584187|NCT03975790|2912713|Superiority|||||||0.2514|||||||t-test||||
1584188|NCT03975790|2912714|Superiority|||||||0.9696|||||||t-test||||
1584189|NCT03975790|2912714|Superiority|||||||0.6155|||||||t-test||||
1584190|NCT03975790|2912714|Superiority|||||||0.5372|||||||t-test||||
1584191|NCT03975790|2912715|Superiority|||||||0.5117|||||||Chi-squared||||
1584192|NCT03975790|2912715|Superiority|||||||0.3586|||||||Chi-squared||||
1584193|NCT03975790|2912716|Superiority|||||||0.6258|||||||Chi-squared||||
1584194|NCT03975790|2912716|Superiority|||||||0.6078|||||||Chi-squared||||
1584195|NCT03975790|2912716|Superiority|||||||0.9215|||||||Chi-squared||||
1584196|NCT03975790|2912717|Superiority|||||||0.7293|||||||t-test||||
1584197|NCT03975790|2912717|Superiority|||||||0.0106|||||||t-test||||
1584198|NCT03975790|2912717|Superiority|||||||0.028|||||||t-test||||
1584199|NCT03975790|2912718|Superiority|||||||0.4546|||||||t-test||||
1584200|NCT03975790|2912718|Superiority|||||||0.1583|||||||t-test||||
1584201|NCT03975790|2912718|Superiority|||||||0.2864|||||||t-test||||
1584202|NCT03975790|2912719|Superiority|||||||0.8376|||||||Chi-squared||||
1584203|NCT03975790|2912719|Superiority|||||||0.8021|||||||Chi-squared||||
1584204|NCT03975790|2912719|Superiority|||||||0.9829|||||||Chi-squared||||
1584205|NCT03975790|2912720|Superiority|||||||0.8316|||||||Chi-squared||||
1584206|NCT03975790|2912720|Superiority|||||||0.7644|||||||Chi-squared||||
1584207|NCT03975790|2912720|Superiority|||||||0.4695|||||||Chi-squared||||
1584208|NCT03966365|2912725|Other|||||||0.651|||||||Wilcoxon (Mann-Whitney)||||
1584209|NCT03966365|2912727|Other|||||||0.031|||||||Chi-squared, Corrected||||
1584210|NCT03966365|2912728|Other|||||||0.253|||||||Wilcoxon (Mann-Whitney)||||
1584211|NCT03966365|2912729|Other|||||||0.49|||||||Chi-squared, Corrected|||Fluorescein treatment groups|
1584212|NCT03966365|2912729|Other|||||||0.081|||||||Chi-squared, Corrected|||Green lissamine treatment groups|
1584213|NCT03966365|2912730|Other|||||||0.622|||||||Wilcoxon (Mann-Whitney)||||
1584214|NCT03966365|2912731|Other|||||||0.706|||||||Wilcoxon (Mann-Whitney)||||
1584215|NCT03965052|2912740|Other|||||||0.019|||||||Wilcoxon (Mann-Whitney)||||
1584216|NCT03965052|2912742|Other|||||||0.977|||||||Chi-squared, Corrected|||the analysis was per protocol|
1584217|NCT03965052|2912743|Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1584218|NCT03965052|2912744|Other|||||||0.667|||||||Fisher Exact|||Fluorescein treatment groups|
1584219|NCT03965052|2912744|Other|||||||1|||||||Fisher Exact|||Lissamine green treatment groups|
1584220|NCT03965052|2912746|Other|||||||1|||||||Fisher Exact||||
1584221|NCT03961308|2912747|Other|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0465|||||2-Sided|90.0|0.9935|1.1023|||||||
1584222|NCT03961308|2912748|Other|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0824|||||2-Sided|90.0|1.0169|1.1521|||||||
1584223|NCT03961308|2912749|Other|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of covariance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0734|||||2-Sided|90.0|0.9963|1.1565|||||||
1584224|NCT03961295|2912750|Other||Ratio of Geometric LSMs|1.1978|||||2-Sided|90.0|1.0394|1.3804||||||Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|
1584225|NCT03961295|2912751|Other||Ratio of Geometric LSMs|1.3274|||||2-Sided|90.0|1.1147|1.5807||||||Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|
1584226|NCT03961295|2912752|Other||Ratio of Geometric LSMs|1.2984|||||2-Sided|90.0|1.0786|1.5486||||||Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|
1584227|NCT03949621|2912753|Other|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0162|||||2-Sided|90.0|0.9001|1.1473|||||||
1584228|NCT03949621|2912754|Other|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9606|||||2-Sided|90.0|0.798|1.1562|||||||
1584267|NCT03882047|2912919|Other||||||<|0.01|||||||ANOVA||||
1584229|NCT03949621|2912755|Other|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of covariance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9632|||||2-Sided|90.0|0.7938|1.1688|||||||
1584230|NCT03948581|2912756|Equivalence|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.006|||||2-Sided|90.0|0.942|1.0743|||||||
1584231|NCT03948581|2912757|Equivalence|Geometric LSMs were calculated by exponentiating the LSMs derived from ANCOVA with weight as a covariate. CIs were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|1.0017|||||2-Sided|90.0|0.9255|1.0841|||||||
1584232|NCT03948581|2912758|Equivalence|Geometric least-squares means (LSMs) were calculated by exponentiating the LSMs derived from analysis of variance (ANCOVA) with weight as a covariate. Confidence intervals (CIs) were calculated using treatment standard errors from the ANCOVA model and t-statistic for error degrees of freedom.|Ratio of Geometric LSMs|0.9846|||||2-Sided|90.0|0.904|1.0723|||||||
1584233|NCT03933449|2912802|Superiority||Hazard Ratio (HR)|0.84||||0.171|2-Sided|95.0|0.57|1.23||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate||
1584234|NCT03933449|2912803|Superiority||Hazard Ratio (HR)|0.81||||0.238|2-Sided|95.0|0.44|1.46||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate||
1584235|NCT03933449|2912804|Superiority||Hazard Ratio (HR)|0.84||||0.177|2-Sided|95.0|0.58|1.23||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate||
1584236|NCT03933449|2912805|Superiority||Difference in Percentages|13.3||||0.0083|2-Sided|95.0|2.8|25.2||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %>0.|Miettinen & Nurminen method||||
1584237|NCT03933449|2912806|Superiority||Difference in Percentages|17.1||||0.0403|2-Sided|95.0|-2.3|38.0||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %>0.|Miettinen & Nurminen method||||
1584238|NCT03933449|2912807|Superiority||Difference in Percentages|12.9||||0.0084|2-Sided|95.0|2.7|24.5||One-sided p-value for testing. H0: difference in %=0 versus H1: difference in %>0.|Miettinen & Nurminen method||||
1584239|NCT03933449|2912808|Superiority||Hazard Ratio (HR)|0.55||||0.0021|2-Sided|95.0|0.37|0.83||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate||
1584240|NCT03933449|2912809|Superiority||Hazard Ratio (HR)|0.34||||0.0008|2-Sided|95.0|0.17|0.69||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate||
1584241|NCT03933449|2912810|Superiority||Hazard Ratio (HR)|0.55||||0.0015|2-Sided|95.0|0.36|0.82||One-sided p-value based on log-rank test|Log Rank||Based on Cox regression model with treatment as a covariate||
1584242|NCT03923933|2912813|Superiority|||||||0.018|||||||ANOVA||||
1584243|NCT03923933|2912814|Superiority|||||||0.028|||||||ANOVA||||
1584244|NCT03923933|2912816|Superiority||||||<|0.001|||||||ANOVA||||
1584245|NCT03923933|2912817|Superiority|||||||0.371|||||||ANOVA||||
1584246|NCT03923933|2912818|Superiority|||||||0.006|||||||ANOVA|Repeated Measures|||
1584247|NCT03923933|2912819|Superiority||||||<|0.001|||||||ANOVA|anova repeated measures|||
1584248|NCT03923530|2912820|Superiority|||||||0.76|||||||t-test, 2 sided|||Change from baseline to 8 weeks|
1584249|NCT03923530|2912821|Superiority|||||||0.8|||||||t-test, 2 sided|||Change from baseline to 8 weeks|
1584250|NCT03923530|2912822|Superiority|||||||0.18|||||||t-test, 2 sided|||Change from baseline to 8 weeks|
1584251|NCT03923530|2912823|Superiority|||||||0.27|||||||t-test, 2 sided|||Change from baseline to 8 weeks|
1584252|NCT03923530|2912824|Superiority|||||||0.03|||||||t-test, 2 sided|||Change from baseline to 8 weeks|
1584253|NCT03923530|2912825|Superiority|||||||0.49|||||||t-test, 2 sided|||Change from baseline to 8 weeks|
1584254|NCT03923530|2912826|Superiority|||||||0.12|||||||t-test, 2 sided|||Change from baseline to 8 weeks|
1584255|NCT03914950|2912829|Other|||||||0.95|||||||DeLong-test|The threshold for statistical significance was p=0.05.|||
1584256|NCT03914950|2912829|Other|"The calculation of power and sample size is based on a formula that selects the sample size so that the lower limit of the 95% confidence interval by the expected specificity of the new method most probably exceeds the specificity value of the current method.~Receiver operating characteristics (ROC) analysis of the values of SUVmax of the early and delayed images with and without TOF of all pancreatic lesions was done in correlation with the histopathological findings."||||||0.78|||||||DeLong-test|The threshold for statistical significance was p=0.05.||It was calculated that 118 participants would have at least 90% power to demonstrate an improvement in specificity of 25% (to 70%) with the new method assuming a specificity of the current method of 45% at a prevalence of malignant lesions of 70% (corresponding to 30% benign lesions). Assumptions included a discontinuation rate of 25%.|
1584257|NCT03888391|2912904|Superiority|||||||0.27|||||||Mixed Models Analysis|Time: F = 1.27, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.|
1584258|NCT03888391|2912905|Superiority|||||||0.32|||||||Mixed Models Analysis|Time: F = 1.04, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.|
1584259|NCT03888391|2912906|Superiority|||||||0.6|||||||Mixed Models Analysis|Time: F = .28, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.|
1584260|NCT03888391|2912907|Superiority|||||||0.0004|||||||Mixed Models Analysis|Time: F = 15.74, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.|
1584261|NCT03888391|2912908|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Time: F = 44.47, df = 1/33||Outcomes fitted via a mixed model with time as a predictor.|
1584262|NCT03888391|2912910|Superiority|||||||0.2|||||||Mixed Models Analysis|Time: F = 1.72, df = 1/34||Outcomes fitted via a mixed model with time as a predictor.|
1584263|NCT03882047|2912918|Other|||||||0.12|||||||ANOVA||||
1584264|NCT03882047|2912918|Other||||||<|0.01|||||||ANOVA||||
1584265|NCT03882047|2912918|Other||||||<|0.01|||||||ANOVA||||
1584268|NCT03882047|2912919|Other||||||<|0.01|||||||ANOVA||||
1584269|NCT03882047|2912920|Other|||||||0.07|||||||ANOVA||||
1584270|NCT03882047|2912920|Other||||||<|0.01|||||||ANOVA||||
1584271|NCT03882047|2912920|Other||||||<|0.01|||||||ANOVA||||
1584272|NCT03882047|2912921|Other|||||||0.46|||||||ANOVA||||
1584273|NCT03882047|2912921|Other||||||<|0.01|||||||ANOVA||||
1584274|NCT03882047|2912921|Other||||||<|0.01|||||||ANOVA||||
1584275|NCT03882047|2912922|Other|||||||0.06|||||||ANOVA||||
1584276|NCT03882047|2912922|Other||||||<|0.01|||||||ANOVA||||
1584277|NCT03882047|2912922|Other||||||<|0.01|||||||ANOVA||||
1584278|NCT03882047|2912923|Other|||||||0.05|||||||ANOVA||||
1584279|NCT03882047|2912923|Other||||||<|0.01|||||||ANOVA||||
1584280|NCT03882047|2912923|Other||||||<|0.02|||||||ANOVA||||
1584281|NCT03882047|2912924|Other|||||||0.01|||||||ANOVA||||
1584282|NCT03882047|2912924|Other||||||<|0.01|||||||ANOVA||||
1584283|NCT03882047|2912924|Other||||||<|0.01|||||||ANOVA||||
1584284|NCT03882047|2912925|Other|||||||0.1|||||||ANOVA||||
1584285|NCT03882047|2912925|Other||||||<|0.01|||||||ANOVA||||
1584286|NCT03882047|2912925|Other||||||<|0.08|||||||ANOVA||||
1584287|NCT03882047|2912926|Other|||||||0.01|||||||ANOVA||||
1584288|NCT03882047|2912926|Other||||||<|0.01|||||||ANOVA||||
1584289|NCT03882047|2912926|Other||||||<|0.01|||||||ANOVA||||
1584290|NCT03882047|2912927|Other|||||||0.31|||||||ANOVA||||
1584291|NCT03882047|2912927|Other||||||<|0.01|||||||ANOVA||||
1584292|NCT03882047|2912927|Other||||||<|0.01|||||||ANOVA||||
1584293|NCT03882047|2912928|Other|||||||0.03|||||||ANOVA||||
1584294|NCT03882047|2912928|Other||||||<|0.01|||||||ANOVA||||
1584295|NCT03882047|2912928|Other||||||<|0.01|||||||ANOVA||||
1584296|NCT03881670|2912930|Other|Friedman test||||||0.4679|||||||Friedman Test|||change in ratings over time|
1584297|NCT03881670|2912930|Other|Friedman test||||||0.0023|||||||Friedman Test|||Change in ratings over time|
1584298|NCT03879772|2912932|Superiority||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584299|NCT03879772|2912932|Superiority||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584300|NCT03879772|2912932|Superiority||||||<|0.79|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584301|NCT03879772|2912932|Superiority||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584302|NCT03879772|2912932|Superiority||||||<|0.73|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584303|NCT03879772|2912932|Superiority||||||<|0.94|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584304|NCT03879772|2912932|Superiority||||||<|0.31|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584305|NCT03879772|2912932|Superiority||||||<|0.11|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584306|NCT03879772|2912932|Superiority||||||<|0.07|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584307|NCT03879772|2912932|Superiority||||||<|0.05|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584308|NCT03879772|2912933|Superiority||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584309|NCT03879772|2912933|Superiority||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584310|NCT03879772|2912933|Superiority||||||<|0.81|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584311|NCT03879772|2912933|Superiority||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584312|NCT03879772|2912933|Superiority||||||<|0.96|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584313|NCT03879772|2912933|Superiority||||||<|0.85|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584314|NCT03879772|2912933|Superiority||||||<|0.14|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584315|NCT03879772|2912933|Superiority||||||<|0.14|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584316|NCT03879772|2912933|Superiority||||||<|0.22|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584317|NCT03879772|2912933|Superiority||||||<|0.16|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584318|NCT03879772|2912934|Superiority|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584319|NCT03879772|2912934|Superiority||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584320|NCT03879772|2912934|Superiority||||||<|0.71|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584321|NCT03879772|2912934|Superiority||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584322|NCT03879772|2912934|Superiority||||||<|0.75|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584323|NCT03879772|2912934|Superiority||||||<|0.93|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584324|NCT03879772|2912934|Superiority||||||<|0.49|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584325|NCT03879772|2912934|Superiority||||||<|0.08|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584326|NCT03879772|2912934|Superiority||||||<|0.04|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584327|NCT03879772|2912934|Superiority||||||<|0.03|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584328|NCT03879772|2912935|Superiority|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584329|NCT03879772|2912935|Superiority|||||||0.09|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584330|NCT03879772|2912935|Superiority|||||||0.42|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584331|NCT03879772|2912935|Superiority|||||||0.23|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584332|NCT03879772|2912935|Superiority|||||||0.17|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584333|NCT03879772|2912935|Superiority|||||||0.6|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584334|NCT03879772|2912935|Superiority|||||||0.36|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584335|NCT03879772|2912935|Superiority|||||||0.12|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584336|NCT03879772|2912935|Superiority|||||||0.45|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584337|NCT03879772|2912935|Superiority|||||||0.8|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584338|NCT03879772|2912936|Superiority||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584339|NCT03879772|2912936|Superiority||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584340|NCT03879772|2912936|Superiority||||||<|0.46|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584341|NCT03879772|2912936|Superiority||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584342|NCT03879772|2912936|Superiority||||||<|0.33|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584343|NCT03879772|2912936|Superiority||||||<|0.81|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584344|NCT03879772|2912936|Superiority||||||<|0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584345|NCT03879772|2912936|Superiority||||||<|0.68|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584346|NCT03879772|2912936|Superiority||||||<|0.74|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584347|NCT03879772|2912936|Superiority||||||<|0.56|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584348|NCT03879772|2912937|Superiority|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584349|NCT03879772|2912937|Superiority|||||||0.02|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584350|NCT03879772|2912937|Superiority|||||||0.8|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584351|NCT03879772|2912937|Superiority|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584352|NCT03879772|2912937|Superiority|||||||0.98|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584353|NCT03879772|2912937|Superiority|||||||0.82|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584354|NCT03879772|2912937|Superiority|||||||0.01|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584355|NCT03879772|2912937|Superiority|||||||0.98|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584356|NCT03879772|2912937|Superiority|||||||0.78|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way ANOVA.|
1584357|NCT03879772|2912937|Superiority|||||||0.95|||||||ANOVA|||Pairwise comparisons were performed using least square means from two-way analysis of variance (ANOVA).|
1584358|NCT03878758|2912939|Superiority|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.4|1.2|||||||
1584359|NCT03878758|2912939|Superiority|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.4|1.2|||||||
1584360|NCT03878758|2912939|Superiority|The number and proportion of needle breaking occurrence for each pen needle type were summarized. A 95% confidence interval for difference in proportions between BD Nano Pro and the Comparator was calculated using the score method for independent proportions.|Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.4|1.2|||||||
1584361|NCT03878758|2912940|Superiority|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary. The upper bound of the confidence interval was compared to 0.|Mean Difference (Net)|-0.068||||0.003|1-Sided|95.0||-0.017|||Mixed Models Analysis|||BD NANO vs Comfort EZ 33G|
1584362|NCT03878758|2912940|Superiority|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Mean Difference (Final Values)|-0.122||||0.104|1-Sided|95.0||0.016|||Mixed Models Analysis|||BD NANO vs Artsana 33G. A significant site effect was detected at one site; the most conservative p-value is reported.|
1584417|NCT03855228|2913027|Superiority||||||<|0.41|||||||ANOVA||||
1584418|NCT03855228|2913028|Superiority|||||||0.8|||||||ANOVA||||
1584363|NCT03878758|2912940|Superiority|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Comparator PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Mean Difference (Final Values)|-0.192|||<|0.001|1-Sided|95.0||-0.141|||Mixed Models Analysis|||BD Nano Pro vs Artsana 34G|
1584364|NCT03878758|2912941|Superiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|0.3|||||2-Sided|95.0|0.13|0.49|||||||
1584365|NCT03878758|2912941|Superiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|1.0|||||2-Sided|95.0|0.8|1.16|||||||
1584366|NCT03878758|2912941|Superiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates.|Overall Mean|0.8|||||2-Sided|95.0|0.62|0.98|||||||
1584367|NCT03878758|2912942|Superiority|The average difference in percentage of occurrence with BD Nano vs.Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-0.2||||0.644|2-Sided|95.0|-1.9|0.6|||Fisher Exact||||
1584368|NCT03878758|2912942|Superiority|The average difference in percentage of occurrence with BD Nano vs. comparator was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-14.09||||0.026|2-Sided|95.0|-26.49|-1.69||Although a site difference was detected - all sites combined p-value was generated,|Fisher Exact||||
1584369|NCT03878758|2912942|Superiority|The average difference in percentage of occurrence with BD Nano vs. comparator was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-5.7|||<|0.001|2-Sided|95.0|-9.0|-3.5|||Fisher Exact||||
1584370|NCT03878758|2912943|Superiority|The average difference in percentage of occurrence with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|0.42||||0.723|2-Sided|95.0|-1.91|2.75|||Fisher Exact||||
1584371|NCT03878758|2912943|Superiority|The average difference in percentage of occurrence with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|0.13||||0.931|2-Sided|95.0|-2.8|3.06|||Fisher Exact||||
1584372|NCT03878758|2912943|Superiority|The average difference in incidence of needle bending with BD Nano vs. Comparator pen needle was calculated with 95% confidence interval and assessed for statistical significance.|Risk Difference (RD)|-0.39||||0.591|2-Sided|95.0|-1.82|1.04|||Fisher Exact||||
1584373|NCT03878745|2912946|Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-1.2|1.2|||||||
1584374|NCT03878745|2912947|Superiority|A mixed effect model was used (fixed effects of PN, abdomen site, order of pair, order of PN within pair and random subject effect) to estimate average difference (BD Nano PN - Terumo PN) in delivery time and total injection time. A Box-Cox transformation might be used to normalize the data if necessary.|Median Difference (Final Values)|-0.5|||<|0.001|1-Sided|95.0||-0.026|||Mixed Models Analysis||||
1584375|NCT03878745|2912948|Other||Mean Difference (Final Values)|-1.5|||||2-Sided|95.0|-3.6|0.1|||||||
1584376|NCT03878745|2912949|Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-1.6|1.6|||||||
1584377|NCT03878745|2912950|Superiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > 0, we can conclude in superiority.|Overall Mean|0.21|||||2-Sided|95.0|0.07|0.35|||||||
1584378|NCT03875664|2912952|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1584379|NCT03870737|2912972|Superiority|||||||0.8|||||||Mixed Models Analysis|Time: F = .06, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.|
1584380|NCT03870737|2912973|Superiority|||||||0.76|||||||Mixed Models Analysis|Time: F = .08, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.|
1584381|NCT03870737|2912974|Superiority|||||||0.67|||||||Mixed Models Analysis|Time: F = .19, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.|
1584382|NCT03870737|2912975|Superiority|||||||0.0005|||||||Mixed Models Analysis|Time: F = 14.28, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.|
1584383|NCT03870737|2912976|Superiority|||||||0.02|||||||Mixed Models Analysis|Time: F = 5.78, df = 1/39.||Outcome was fitted using a mixed model with time as predictor.|
1584384|NCT03870737|2912978|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Time: F = 24.81, df = 1/40.||Outcomes fitted via a mixed effects model with time as predictor.|
1584385|NCT03868631|2912985|Superiority||||||<|0.05|||||||multilevel models for change|||Between-group differences at baseline were compared using independent t-tests. Multilevel models for change (MLM) were used to determine differences between groups over time for study outcomes. Age, sex, and number of sessions missed were included as covariates. Time and time by group interactions were examined. Analyses were conducted using IBM SPSS Statistics version 23. Significance was set at p<0.05.|
1584419|NCT03855228|2913028|Superiority||||||<|0.01|||||||ANOVA||||
1584420|NCT03855228|2913028|Superiority||||||<|0.01|||||||ANOVA||||
1584421|NCT03855228|2913028|Superiority||||||<|0.01|||||||ANOVA||||
1584422|NCT03855228|2913028|Superiority||||||<|0.01|||||||ANOVA||||
1584423|NCT03855228|2913028|Superiority||||||<|0.29|||||||ANOVA||||
1584424|NCT03855228|2913029|Superiority|||||||0.58|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584386|NCT03866434|2912987|Equivalence|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|86.504|||||2-Sided|90.0|78.462|95.371|||||This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole [Day 8] versus anagrelide alone [Day 1]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.|
1584387|NCT03866434|2912988|Equivalence|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|73.007|||||2-Sided|90.0|62.528|85.243|||||This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole [Day 8] versus anagrelide alone [Day 1]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.|
1584388|NCT03866434|2912989|Equivalence|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|85.527|||||2-Sided|90.0|78.163|93.584|||||This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole [Day 8] versus anagrelide alone [Day 1]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.|
1584389|NCT03866434|2912990|Equivalence|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LS means|73.705|||||2-Sided|90.0|64.555|84.152|||||This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole [Day 8] versus anagrelide alone [Day 1]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.|
1584390|NCT03866434|2912991|Equivalence|90% CIs of geometric mean ratios being within 80% to 125%.|%ratio of Geometric LeastSquare(LS)means|82.203|||||2-Sided|90.0|71.501|94.507|||||This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole [Day 8] versus anagrelide alone [Day 1]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the LS mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CI were calculated.|
1584391|NCT03866434|2912992|Equivalence|90% CIs of geometric mean ratios being within 80% to 125%.|% ratio of Geometric LSmeans|64.225|||||2-Sided|90.0|53.212|77.516|||||This analysis was performed based on the ratio of geometric LS means and 90% confidence interval for ratio of geometric means expressed as percent.|The means of the log-transformed pharmacokinetic parameters were compared between the two treatments (anagrelide with omeprazole [Day 8] versus anagrelide alone [Day 1]). In order to estimate the magnitude of the treatment regimen differences, the geometric mean ratio (i.e., the least squares (LS) mean difference in the log-transformed parameters back transformed to the original scale) and their 90 percent (%) confidence intervals (CI) were calculated.|
1584392|NCT03861559|2912993|Other||||||<|0.01|||||||ANOVA||||
1584393|NCT03861559|2912994|Other||||||<|0.01|||||||ANOVA||||
1584394|NCT03861559|2912995|Other||||||<|0.01|||||||ANOVA||||
1584395|NCT03861559|2912996|Other||||||<|0.01|||||||ANOVA||||
1584396|NCT03861559|2912997|Other||||||<|0.01|||||||ANOVA||||
1584397|NCT03861559|2912998|Other||||||<|0.01|||||||ANOVA||||
1584398|NCT03861559|2913000|Other||||||<|0.01|||||||ANOVA||||
1584399|NCT03861559|2913001|Other||||||<|0.01|||||||ANOVA||||
1584400|NCT03861559|2913002|Other|||||||0.15|||||||ANOVA||||
1584401|NCT03861559|2913004|Other||||||<|0.01|||||||ANOVA||||
1584402|NCT03861559|2913005|Other|||||||0.02|||||||ANOVA||||
1584403|NCT03861559|2913006|Other|||||||0.14|||||||ANOVA||||
1584404|NCT03861559|2913008|Other||||||<|0.01|||||||ANOVA||||
1584405|NCT03861559|2913009|Other||||||<|0.01|||||||ANOVA||||
1584406|NCT03861559|2913010|Other||||||<|0.01|||||||ANOVA||||
1584407|NCT03861559|2913012|Other||||||<|0.01|||||||ANOVA||||
1584408|NCT03861559|2913013|Other||||||<|0.01|||||||Log Rank||||
1584409|NCT03859622|2913018|Other|Frequencies and percentages for categorical data.||||||||||||||||Standard methods are used for the description of data (frequencies and percentages for categorical data)|Standard methods are used for the description of data (frequencies and percentages for categorical data)
1584410|NCT03857230|2913025|Equivalence|The 90% CIs of the ratios of geometric means of log-transformed baseline Cmax were used to assess bioequivalence between Primapur and Gonal-F (bioequivalence range of 80.00% to 125.00%)|Geometric Mean Ratio (%)|87.93||||0.05|2-Sided|90.0|82.85|93.33|||ANOVA||||
1584411|NCT03857230|2913026|Equivalence|The 90% CIs of the ratios of geometric means of log-transformed baseline AUC0-192 were used to assess bioequivalence between Primapur and Gonal-F (bioequivalence range of 80.00% to 125.00%)|Geometric Mean Ratio (%)|93.31||||0.05|2-Sided|90.0|87.25|99.79|||ANOVA|||Statistical comparison of the obtained results comprised the calculation of parametric bilateral 90 % CIs for the ratios of the corresponding mean values of the pharmacokinetic parameters of the study and comparator drug. The equivalence of the pharmacokinetics of the drug products will be proven if the limits of the evaluated CIs for the ratios of the mean values are in the range of 80.00-125.00%.|
1584412|NCT03855228|2913027|Superiority|||||||0.08|||||||ANOVA||||
1584413|NCT03855228|2913027|Superiority||||||<|0.01|||||||ANOVA||||
1584414|NCT03855228|2913027|Superiority||||||<|0.01|||||||ANOVA||||
1584415|NCT03855228|2913027|Superiority||||||<|0.01|||||||ANOVA||||
1584416|NCT03855228|2913027|Superiority||||||<|0.01|||||||ANOVA||||
1584425|NCT03855228|2913029|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584426|NCT03855228|2913029|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584427|NCT03855228|2913029|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584428|NCT03855228|2913029|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584429|NCT03855228|2913029|Superiority||||||<|0.95|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584430|NCT03855228|2913030|Superiority|||||||0.92|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584431|NCT03855228|2913030|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584432|NCT03855228|2913030|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584433|NCT03855228|2913030|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584434|NCT03855228|2913030|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584435|NCT03855228|2913030|Superiority||||||<|0.65|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584436|NCT03855228|2913031|Superiority|||||||0.22|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584437|NCT03855228|2913031|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584438|NCT03855228|2913031|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584439|NCT03855228|2913031|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584440|NCT03855228|2913031|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584441|NCT03855228|2913031|Superiority||||||<|0.88|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584442|NCT03855228|2913032|Superiority|||||||0.17|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584443|NCT03855228|2913032|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584444|NCT03855228|2913032|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584445|NCT03855228|2913032|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584446|NCT03855228|2913032|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584447|NCT03855228|2913032|Superiority||||||<|0.85|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584448|NCT03855228|2913033|Superiority|||||||0.08|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584449|NCT03855228|2913033|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584450|NCT03855228|2913033|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584451|NCT03855228|2913033|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584452|NCT03855228|2913033|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584453|NCT03855228|2913033|Superiority||||||<|0.99|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584454|NCT03855228|2913034|Superiority|||||||0.45|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584455|NCT03855228|2913034|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584456|NCT03855228|2913034|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584457|NCT03855228|2913034|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584458|NCT03855228|2913034|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584459|NCT03855228|2913034|Superiority||||||<|0.77|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584460|NCT03855228|2913035|Superiority|||||||0.02|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584461|NCT03855228|2913035|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584462|NCT03855228|2913035|Superiority||||||<|0.03|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584463|NCT03855228|2913035|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584464|NCT03855228|2913035|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584465|NCT03855228|2913035|Superiority||||||<|0.35|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584466|NCT03855228|2913036|Superiority|||||||0.02|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584467|NCT03855228|2913036|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584468|NCT03855228|2913036|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584469|NCT03855228|2913036|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584470|NCT03855228|2913036|Superiority||||||<|0.01|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584471|NCT03855228|2913036|Superiority||||||<|0.36|||||||ANOVA|||This analysis compares Change From Baseline values.|
1584472|NCT03855189|2913037|Other|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584473|NCT03855189|2913037|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584474|NCT03855189|2913037|Other||||||<|0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584475|NCT03855189|2913038|Other|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584476|NCT03855189|2913038|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584477|NCT03855189|2913038|Other||||||<|0.13|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584478|NCT03855189|2913039|Other|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584479|NCT03855189|2913039|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584480|NCT03855189|2913039|Other||||||<|0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584481|NCT03855189|2913040|Other|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584482|NCT03855189|2913040|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584483|NCT03855189|2913040|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584484|NCT03855189|2913041|Other|||||||0.34|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584485|NCT03855189|2913041|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584486|NCT03855189|2913041|Other||||||<|0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584487|NCT03855189|2913042|Other|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584488|NCT03855189|2913042|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584489|NCT03855189|2913042|Other||||||<|0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584490|NCT03855189|2913043|Other|||||||0.53|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584491|NCT03855189|2913043|Other|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584492|NCT03855189|2913043|Other|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584493|NCT03855189|2913044|Other|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584494|NCT03855189|2913044|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584495|NCT03855189|2913044|Other||||||<|0.05|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584496|NCT03855189|2913045|Other|||||||0.09|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584497|NCT03855189|2913045|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584498|NCT03855189|2913045|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584499|NCT03855189|2913046|Other|||||||0.26|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584500|NCT03855189|2913046|Other|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584501|NCT03855189|2913046|Other|||||||0.25|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584502|NCT03855189|2913047|Other|||||||0.64|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584503|NCT03855189|2913047|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584504|NCT03855189|2913047|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584505|NCT03855189|2913048|Other|||||||0.96|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584506|NCT03855189|2913048|Other|||||||0.08|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584507|NCT03855189|2913048|Other|||||||0.09|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584508|NCT03855189|2913049|Other|||||||0.43|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584509|NCT03855189|2913049|Other|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584510|NCT03855189|2913049|Other|||||||0.07|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584511|NCT03855189|2913050|Other|||||||0.59|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584512|NCT03855189|2913050|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584513|NCT03855189|2913050|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584514|NCT03855189|2913051|Other|||||||0.6|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584515|NCT03855189|2913051|Other|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584516|NCT03855189|2913051|Other|||||||0.11|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584517|NCT03855189|2913052|Other|||||||0.77|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584518|NCT03855189|2913052|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584519|NCT03855189|2913052|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584520|NCT03855189|2913053|Other|||||||0.71|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584521|NCT03855189|2913053|Other|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584522|NCT03855189|2913053|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584523|NCT03855189|2913054|Other|||||||0.54|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584524|NCT03855189|2913054|Other|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584525|NCT03855189|2913054|Other|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584526|NCT03855189|2913055|Other|||||||0.6|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584527|NCT03855189|2913055|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584528|NCT03855189|2913055|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584529|NCT03855189|2913056|Other|||||||0.39|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584530|NCT03855189|2913056|Other|||||||0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584531|NCT03855189|2913056|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584532|NCT03855189|2913057|Other|||||||0.17|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584533|NCT03855189|2913057|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584534|NCT03855189|2913057|Other||||||<|0.02|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584535|NCT03855189|2913058|Other|||||||0.81|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584536|NCT03855189|2913058|Other|||||||0.03|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584537|NCT03855189|2913058|Other|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584538|NCT03855189|2913059|Other|||||||0.13|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584539|NCT03855189|2913059|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584540|NCT03855189|2913059|Other||||||<|0.05|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584541|NCT03855189|2913060|Other|||||||0.11|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584542|NCT03855189|2913060|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584543|NCT03855189|2913060|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584544|NCT03855189|2913063|Other|||||||0.5|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584545|NCT03855189|2913063|Other|||||||0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584546|NCT03855189|2913063|Other|||||||0.04|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584547|NCT03855189|2913064|Other|||||||0.06|||||||ANOVA|||Pairwise treatment comparison based on t-test from ANOVA.|
1584548|NCT03855189|2913064|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from ANOVA.|
1584549|NCT03855189|2913064|Other||||||<|0.01|||||||ANOVA|||Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).|
1584550|NCT03850444|2913088|Other||Difference in Percentage (DP)|8.0|||||2-Sided|95.0|-3.0|18.9|||||DP for pembrolizumab vs. chemotherapy based on Miettinen & Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).||
1584551|NCT03850444|2913089|Other||Difference in Percentage (DP)|11.3|||||2-Sided|95.0|-1.4|23.7|||||DP for pembrolizumab vs. chemotherapy based on Miettinen & Nurminen method stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).||
1584552|NCT03850444|2913090|Other||r Difference in Percentage (DP)|17.2|||||2-Sided|95.0|1.8|31.6|||||DP for pembrolizumab vs. chemotherapy based on Miettinen & Nurminen method stratified by ECOG PS (0 vs. 1) and histology (squamous vs. non-squamous).||
1584553|NCT03850444|2913091|Other||Hazard Ratio (HR)|1.0|||||2-Sided|95.0|0.74|1.35|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).||
1584554|NCT03850444|2913092|Other||Hazard Ratio (HR)|0.99|||||2-Sided|95.0|0.7|1.39|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).||
1584555|NCT03850444|2913093|Other||Hazard Ratio (HR)|0.85|||||2-Sided|95.0|0.57|1.28|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).||
1584556|NCT03850444|2913094|Other||Hazard Ratio (HR)|0.65|||||2-Sided|95.0|0.45|0.94|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).||
1584557|NCT03850444|2913095|Other||Hazard Ratio (HR)|0.62|||||2-Sided|95.0|0.41|0.95|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%), and histology (squamous vs. non-squamous).||
1584558|NCT03850444|2913096|Other||Hazard Ratio (HR)|0.62|||||2-Sided|95.0|0.38|1.0|||||Hazard ratio based on Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).||
1584559|NCT03849690|2913112|Other|ANOVA was performed on ln-transformed TAK-906 AUC∞ which were exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as a random effect. Each ANOVA included calculation of LSM and difference between treatment LSM. Geometric mean ratios and 90% CI were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.88||||0.3011|2-Sided|90.0|0.78|1.0|||ANOVA||||
1584560|NCT03849690|2913113|Other|ANOVA was performed on ln-transformed TAK-906 AUClast which were exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as a random effect. Each ANOVA included calculation of LSM and difference between treatment LSM. Geometric mean ratios and 90 percent (%) CI were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.88||||0.0865|2-Sided|90.0|0.77|0.99|||ANOVA||||
1584561|NCT03849690|2913114|Other|Analysis of variance (ANOVA) performed on natural log(ln)-transformed TAK-906 Cmax which exponentiated to provide estimates on original scale. ANOVA model included treatment as fixed effect and participant as random effect. Each ANOVA included calculation of least-squares means(LSM) and difference between treatment LSM. Geometric mean ratios and 90% confidence interval (CI) were determined by exponentiation of appropriate estimates for difference between treatments in log-transformed parameters.|Geometric mean ratio|0.87||||0.3011|2-Sided|90.0|0.7|1.09|||ANOVA||||
1584562|NCT03848455|2913145|Other||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of NSF gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) – CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) – CT(ref, calibrator),ΔΔCT = ΔCT(test) – ΔCT(calibrator).|
1584563|NCT03848455|2913145|Other||||||<|0.149|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of PPP3CB gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) – CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) – CT(ref, calibrator),ΔΔCT = ΔCT(test) – ΔCT(calibrator).|
1584564|NCT03848455|2913145|Other||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of SYNJ1 gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) – CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) – CT(ref, calibrator),ΔΔCT = ΔCT(test) – ΔCT(calibrator).|
1584565|NCT03848455|2913145|Other||||||<|0.001|||||||Kruskal-Wallis|||we use the method of RT-PCR to detect the relative expression level of PPP2CA gene in Parkinson's disease group(90 participants), healthy controls group(125 participants) and Parkinson-plus syndrome group(23 participants).This gene expression is relative to a house keeping gene GAPDH.The data were processed using 2-△△Ct. ΔCT(test) = CT(target, test) – CT(ref, test), ΔCT(calibrator) = CT(target, calibrator) – CT(ref, calibrator),ΔΔCT = ΔCT(test) – ΔCT(calibrator).|
1584566|NCT03848221|2913146|Equivalence|||||||0.0002|||||||ANOVA||||
1584567|NCT03848221|2913147|Equivalence|||||||0.3|||||||ANOVA||||
1584568|NCT03824236|2913329|Other|Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the disease for vaccinated people (NP-Fx Group) compared to unvaccinated people (Infectivity Control Group).|Vaccine efficacy rate|54.0||||0.002|2-Sided|95.0|29.0|70.0|||Fisher Exact|||Efficacy analysis aimed at comparing P. falciparum parasitemia incidence after sporozoite challenge between NP-Fx group and the Infectivity Control group.|
1584569|NCT03824236|2913329|Other|Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the disease for vaccinated people (P-Fx Group) compared to unvaccinated people (Infectivity Control Group).|Vaccine efficacy rate|52.0||||0.003|2-Sided|95.0|28.0|68.0|||Fisher Exact|||Efficacy analysis aimed at comparing P. falciparum parasitemia incidence after sporozoite challenge between P-Fx group and the Infectivity Control group.|
1584570|NCT03817775|2913365|Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1584571|NCT03817775|2913366|Other|||||||0.5675|||||||Wilcoxon (Mann-Whitney)||||
1584572|NCT03817775|2913367|Other|||||||0.7215|||||||Wilcoxon (Mann-Whitney)||||
1584573|NCT03817775|2913368|Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1584574|NCT03817775|2913369|Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1584575|NCT03811093|2913518|Other|||||||0.438|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.|
1584576|NCT03811093|2913518|Other|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of the Weight of Body Fat Lost or Gained is normal with mean -2.49 and standard deviation 3.71209."|
1584577|NCT03811093|2913518|Superiority||Mean Difference (Net)|4.4703|||<|0.01|2-Sided|95.0|2.3372|6.6034||p-value is computed using SPSS.|t-test, 2 sided|||Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change in body fat, measured in pounds. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. change in pounds of body fat.|
1584578|NCT03811093|2913519|Other|||||||0.44|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.|
1584579|NCT03811093|2913519|Other|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Total Inches Lost or Gained is normal with mean -7.136 and standard deviation 5.796."|
1584628|NCT03782571|2913649|Equivalence|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|6.6|Standard Error of the Mean|4.95|||2-Sided|99.1|-7.8|20.9|||||Test 2 – Control|Testing equivalence with respect to microsphere uptake rate.|
1591284|NCT03135015|2926022|Other|||||||0.8444|||||||t-test, 2 sided||||
1584580|NCT03811093|2913519|Superiority||Mean Difference (Net)|7.063|||<|0.01|2-Sided|95.0|3.829|10.296||p-value is calculated using SPSS.|t-test, 2 sided|||Designed as a superiority trial with the aim of establishing whether the intervention was superior or inferior to a placebo in effectiveness as a therapy for change over time in measured body circumference. The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. measured body circumference.|
1584581|NCT03811093|2913520|Other|||||||0.075|||||||Levene's Test for Equality of Variance|||To test that the trial participant's population variances are equal (or exhibit homogeneity of variance), a Levene's Test for Equality of Variance was conducted. It tests the null hypothesis that the population variances are equal (called homogeneity of variance or homoscedasticity). For this test if the resulting p-value of Levene's test is less than .05, the obtained differences in sample variances are unlikely to have occurred based on random sampling from a population with equal variances.|
1584582|NCT03811093|2913520|Other|||||||0.2||||||The significance value has been Lilliefors corrected and represents the lower bound of the true significance.|Kolmogorov-Smirnov Test|||"A single sample Kolmogorov-Smirnov normality test was used to examine if variables are normally distributed for the population from which the trial groups are drawn.~The null hypothesis is that the distribution of Percent of Body Fat Lost or Gained is normal with mean -.83 and standard deviation 1.50218."|
1584583|NCT03811093|2913520|Superiority||Mean Difference (Net)|2.036|||<|0.01|2-Sided|95.0|1.243|2.828||p-value is calculated using SPSS.|t-test, 2 sided|||The null hypothesis states that in the population from where the sample was obtained there was no difference between the intervention (invisa-RED Elite) and placebo groups in the mean change in the primary outcome variable, i.e. Change in Body Fat Percentage.|
1584584|NCT03808493|2913527|Equivalence|For log-transformed (natural log) λz, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0135|||||2-Sided|90.0|-0.0508|0.0238|||||||
1584585|NCT03808493|2913527|Equivalence|For log-transformed (natural log) λz, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0209|||||2-Sided|90.0|-0.0112|0.053|||||||
1584586|NCT03808493|2913528|Equivalence|For log-transformed (natural log) MRT∞,ev, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0306|||||2-Sided|90.0|-0.0003|0.0616|||||||
1584587|NCT03808493|2913528|Equivalence|For log-transformed (natural log) MRT∞,ev, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0311|||||2-Sided|90.0|0.0022|0.0599|||||||
1584588|NCT03808493|2913529|Equivalence|For log-transformed (natural log) Tmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.2142|||||2-Sided|90.0|0.0558|0.3725|||||||
1584589|NCT03808493|2913529|Equivalence|For log-transformed (natural log) Tmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.1902|||||2-Sided|90.0|0.0199|0.3605|||||||
1584590|NCT03808493|2913530|Equivalence|For log-transformed (natural log) AUC∞, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0035|||||2-Sided|90.0|-0.076|0.083|||||||
1584591|NCT03808493|2913530|Equivalence|For log-transformed (natural log) AUC∞, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0199|||||2-Sided|90.0|-0.0731|0.0333|||||||
1584592|NCT03808493|2913531|Equivalence|For log-transformed (natural log) Cmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0811|||||2-Sided|90.0|-0.1658|0.0036|||||||
1584593|NCT03808493|2913531|Equivalence|For log-transformed (natural log) Cmax, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0698|||||2-Sided|90.0|-0.1404|0.0008|||||||
1584594|NCT03808493|2913532|Equivalence|For log-transformed (natural log) AUClast, the two-sided 90% CI of the difference in the LS-Means between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|0.0019|||||2-Sided|90.0|-0.0778|0.0815|||||||
1584595|NCT03808493|2913532|Equivalence|For log-transformed (natural log) AUClast, the two-sided 90% CI of the difference in the least square means (LS-Means) between the formulations (TAK-438 OD tablet-TAK-438 tablet) was provided using the ANOVA model.|LS-Means Difference|-0.0211|||||2-Sided|90.0|-0.0752|0.0329|||||||
1584596|NCT03807700|2913541|Superiority||Mean Difference (Net)|-0.41|Standard Error of the Mean|0.58||0.4769|2-Sided|95.0|-1.56|0.74|||ANCOVA|Analysis was performed using ANCOVA model with study product as a fixed effect and Baseline overall score as a covariate.|Difference is experimental adhesive minus no adhesive.||
1584597|NCT03805971|2913559|Superiority||||||<|0.0001|||||||Fisher Exact|||"The objective is to assess if dysplastic vessels are more frequently found in the malignant pleural infiltrations group than in the benign pleura group."|
1584598|NCT03805971|2913559|Superiority||||||<|0.0052|||||||Fisher Exact|||"The objective is to assess if the pCLE feature cellular shape homogeneity is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group."|
1584599|NCT03805971|2913559|Superiority||||||<|0.0001|||||||Fisher Exact|||"The objective is to assess if the abnormal tissular architecture is significantly more frequently found in the malignant pleural infiltrations group than in the benign pleura group."|
1584600|NCT03805971|2913559|Superiority||||||<|0.0003|||||||Fisher Exact|||"The objective of the test is to assess if the pCLE feature full chia seed sign is found statistically more frequently in the benign pleura group than in the malignant pleural infiltrations group."|
1584629|NCT03782571|2913649|Equivalence|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|8.4|Standard Error of the Mean|3.24|||2-Sided|99.1|-1.0|17.8|||||Test 1 – Control|Testing equivalence with respect to microsphere uptake rate.|
1584601|NCT03801148|2913561|Equivalence|ln-transformed- AUC0_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0_infpred.|Geometric LSM ratio|1.0472|||||2-Sided|90.0|1.0029|1.0934|||||||
1584602|NCT03801148|2913561|Equivalence|ln-transformed- AUC0_infpred, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0_infpred.|Geometric LSM ratio|1.0555|||||2-Sided|90.0|1.0188|1.0935|||||||
1584603|NCT03801148|2913562|Equivalence|ln-transformed- AUC0_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0_infobs.|GMR|1.0468|||||2-Sided|90.0|1.0027|1.0929|||||||
1584604|NCT03801148|2913562|Equivalence|ln-transformed- AUC0_infobs, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUC0_infobs.|Geometric LSM ratio|1.0553|||||2-Sided|90.0|1.0186|1.0933|||||||
1584605|NCT03801148|2913563|Equivalence|ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.|Geometric LSM ratio|1.061|||||2-Sided|90.0|1.0192|1.1046|||||||
1584606|NCT03801148|2913563|Equivalence|ln-transformed- AUClast, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed AUClast.|Geometric LSM ratio|1.0455|||||2-Sided|90.0|1.007|1.0855|||||||
1584607|NCT03801148|2913564|Equivalence|ln-transformed-Cmax, was analyzed using an ANOVA model to assess the relative bioavailability of dexlansoprazole 60 mg capsule manufactured at TOB compared with dexlansoprazole 60 mg capsule manufactured at TPC. Geometric LSM ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.|Geometric LSM ratio|1.0737|||||2-Sided|90.0|1.0025|1.1501|||||||
1584608|NCT03801148|2913564|Equivalence|Natural log (ln)-transformed-Cmax, was analyzed using an analysis of variance (ANOVA) model to assess the relative bioavailability of dexlansoprazole 30 mg capsule manufactured at TOB compared with dexlansoprazole 30 mg capsule manufactured at TPC. Geometric least square mean (LSM) ratios were calculated using the exponentiation of the difference between treatment LSM from the analyses on the ln-transformed Cmax.|Geometric LSM ratio|0.98|||||2-Sided|90.0|0.9171|1.0473|||||||
1584609|NCT03801044|2913580|Other|||||||0.039|||||||Wilcoxon (Mann-Whitney)||||
1584610|NCT03800030|2913581|Superiority|||||||0.007|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 2.989|||
1584611|NCT03800030|2913582|Superiority|||||||0.54|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = -0.623|||
1584612|NCT03800030|2913583|Superiority|||||||0.02|||||||t-test, 1 sided|degrees of freedom = 22 t-statistic = 2.174|||
1584613|NCT03800030|2913584|Superiority|||||||0.04|||||||t-test, 1 sided|degrees of freedom = 22 t-statistic = 1.833|||
1584614|NCT03800030|2913585|Superiority|||||||0.935|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 0.083|||
1584615|NCT03800030|2913586|Superiority|||||||0.031|||||||t-test, 2 sided|degrees of freedom = 22 t-statistic = 2.305|||
1584616|NCT03796182|2913600|Equivalence|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|94.25|||||2-Sided|90.0|88.19|100.73|||||||
1584617|NCT03796182|2913602|Equivalence|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|88.07|||||2-Sided|90.0|80.99|95.76|||||||
1584618|NCT03796182|2913603|Equivalence|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|93.49|||||2-Sided|90.0|85.15|102.65|||||||
1584619|NCT03796182|2913604|Equivalence|The corresponding 90% confidence intervals equivalence criteria was (80%, 125%) acceptance range.|Ratio|98.5|||||2-Sided|90.0|82.09|118.2|||||||
1584620|NCT03793556|2913618|Other|||||||0.0065|||||||ANOVA||||
1584621|NCT03793556|2913620|Other|||||||0.0496|||||||Chi-squared||||
1584622|NCT03793556|2913630|Other|||||||0.0157|||||||ANOVA|The ANOVA model examined the entire curve profile.|||
1584623|NCT03793556|2913631|Other||Mean Difference (Final Values)|-2.5|Standard Deviation|9.27||0.276|2-Sided|95.0|-7.03|2.04|||Unpaired t test||||
1584624|NCT03782571|2913649|Equivalence|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-1.8|Standard Error of the Mean|4.18|||2-Sided|99.1|-13.9|10.3|||||Test 2 – Test 1|Testing equivalence with respect to microsphere uptake rate.|
1584625|NCT03782571|2913649|Equivalence|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-3.7|Standard Error of the Mean|3.1|||2-Sided|99.1|-12.6|5.3|||||Test 3 – Test 2|Testing equivalence with respect to microsphere uptake rate.|
1584626|NCT03782571|2913649|Equivalence|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|-5.5|Standard Error of the Mean|5.13|||2-Sided|99.1|-20.4|9.4|||||Test 3 – Test 1|Testing equivalence with respect to microsphere uptake rate.|
1584627|NCT03782571|2913649|Equivalence|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|2.9|Standard Error of the Mean|6.22|||2-Sided|99.1|-15.1|20.9|||||Test 3 – Control|Testing equivalence with respect to microsphere uptake rate.|
1584689|NCT03739242|2913843|Superiority||Least Square Mean difference|-5.95||||0.2595|2-Sided|95.0|-16.37|4.47|||ANCOVA||||
1584630|NCT03782571|2913650|Equivalence|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|3.0|Standard Error of the Mean|2.54|||2-Sided|99.1|-4.3|10.3|||||Test 2 – Test 1|Testing equivalence with respect to microsphere clearance rate.|
1584631|NCT03782571|2913650|Equivalence|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|3.5|Standard Error of the Mean|1.88|||2-Sided|99.1|-2.0|8.9|||||Test 3 – Test 2|Testing equivalence with respect to microsphere clearance rate.|
1584632|NCT03782571|2913650|Equivalence|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|6.5|Standard Error of the Mean|3.12|||2-Sided|99.1|-2.6|15.5|||||Test 3 – Test 1|Testing equivalence with respect to microsphere clearance rate.|
1584633|NCT03782571|2913650|Equivalence|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|8.2|Standard Error of the Mean|3.78|||2-Sided|99.1|-2.7|19.1|||||Test 3 – Control|Testing equivalence with respect to microsphere clearance rate.|
1584634|NCT03782571|2913650|Equivalence|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|4.7|Standard Error of the Mean|3.01|||2-Sided|99.1|-4.0|13.4|||||Test 2 – Control|Testing equivalence with respect to microsphere clearance rate.|
1584635|NCT03782571|2913650|Equivalence|Equivalence is concluded if the upper limit is less than 10% and the lower limit is greater than -10%.|Mean Difference (Final Values)|1.7|Standard Error of the Mean|1.97|||2-Sided|99.1|-4.0|7.4|||||Test 1 – Control|Testing equivalence with respect to microsphere clearance rate.|
1584636|NCT03780959|2913665|Superiority|||||||0.0001|||||||Log Rank||||
1584637|NCT03780959|2913666|Superiority|||||||0.003|||||||Mantel Haenszel|Stratified by study center and the number of active joints at randomization|||
1584638|NCT03772522|2913695|Superiority||Cohen's d (effect size)|0.53||||0.039|2-Sided||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 9-months post-intervention.|
1584639|NCT03772522|2913695|Superiority||Cohen's d (effect size)|0.71||||0.006|2-Sided||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 6-months post-intervention.|
1584640|NCT03772522|2913695|Superiority||Cohen's d (effect size)|0.29||||0.217|2-Sided||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and 3-months post-intervention.|
1584641|NCT03772522|2913695|Superiority||Cohen's d (effect size)|0.62||||0.014|2-Sided||||||t-test, 2 sided|||Comparison of RSS scores at baseline (pre-intervention) and immediately post-intervention.|
1584642|NCT03772522|2913695|Superiority||Cohen's d (effect size)|1.161||||0.026|2-Sided||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).|
1584643|NCT03772522|2913696|Superiority||Cohen's d (effect size)|0.37||||0.133|2-Sided||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 9-months post-intervention.|
1584644|NCT03772522|2913696|Superiority||Cohen's d (effect size)|0.33||||0.168|2-Sided||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 6-months post-intervention.|
1584645|NCT03772522|2913696|Superiority||Cohen's d (effect size)|0.42||||0.087|2-Sided||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and 3-months post-intervention.|
1584646|NCT03772522|2913696|Superiority||Cohen's d (effect size)|0.19||||0.417|2-Sided||||||t-test, 2 sided|||Comparison of SCS scores at baseline (pre-intervention) and immediately post-intervention.|
1584647|NCT03772522|2913696|Superiority||Cohen's d (effect size)|0.101||||0.834|2-Sided||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).|
1584648|NCT03772522|2913697|Superiority||Cohen's d (effect size)|-0.07||||0.762|2-Sided||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 9-months post-intervention.|
1584649|NCT03772522|2913697|Superiority||Cohen's d (effect size)|0.32||||0.197|2-Sided||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 9-months post-intervention.|
1584650|NCT03772522|2913697|Superiority||Cohen's d (effect size)|0.01||||0.956|2-Sided||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 6-months post-intervention.|
1584651|NCT03772522|2913697|Superiority||Cohen's d (effect size)|0.51||||0.038|2-Sided||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 6-months post-intervention.|
1584652|NCT03772522|2913697|Superiority||Cohen's d (effect size)|0.09||||0.688|2-Sided||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 3-months post-intervention.|
1584653|NCT03772522|2913697|Superiority||Cohen's d (effect size)|0.52||||0.037|2-Sided||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and 3-months post-intervention.|
1584654|NCT03772522|2913697|Superiority||Cohen's d (effect size)|0.2||||0.388|2-Sided||||||t-test, 2 sided|||Comparison of CIS (psychological component) scores at baseline (pre-intervention) and immediately post-intervention.|
1584655|NCT03772522|2913697|Superiority||Cohen's d (effect size)|0.6||||0.18|2-Sided||||||t-test, 2 sided|||Comparison of CIS (physical component) scores at baseline (pre-intervention) and immediately post-intervention.|
1584656|NCT03772522|2913697|Superiority||Cohen's d (effect size)|0.047||||0.923|2-Sided||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the psychological component of the CIS.|
1584657|NCT03772522|2913697|Superiority||Cohen's d (effect size)|1.792||||0.002|2-Sided||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the physical component of the CIS.|
1584658|NCT03772522|2913698|Superiority||Cohen's d (effect size)|-0.6||||0.022|2-Sided||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 9-months post-intervention.|
1584690|NCT03739242|2913844|Superiority||Least Square Mean difference|6.02||||0.2654|2-Sided|95.0|-4.66|16.69|||ANCOVA||||
1584659|NCT03772522|2913698|Superiority||Cohen's d (effect size)|-0.73||||0.005|2-Sided||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 6-months post-intervention.|
1584660|NCT03772522|2913698|Superiority||Cohen's d (effect size)|-0.4||||0.095|2-Sided||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and 3-month post-intervention.|
1584661|NCT03772522|2913698|Superiority||Cohen's d (effect size)|-0.46||||0.058|2-Sided||||||t-test, 2 sided|||Comparison of scores at baseline (pre-intervention) and immediately post-intervention.|
1584662|NCT03772522|2913698|Superiority||Cohen's d (effect size)|0.384||||0.428|2-Sided||||||t-test, 2 sided|||Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).|
1584663|NCT03772327|2913699|Superiority||Difference in proportions|0.019||||1|2-Sided|95.0|-0.237|0.276|||Chi-squared, Corrected|||Null hypothesis: Adherence in the AdhereTech bottle arm is not better than the control arm at Week 12.|
1584664|NCT03772327|2913701|Superiority||Odds Ratio (OR)|0.395||||0.294|2-Sided|95.0|0.058|2.044|||Fisher Exact||Odds ratio for change from HIV RNA ≥ 20 copies/mL at baseline to HIV RNA < 20 copies/mL at week 12 due to the intervention (AdhereTech bottle).|Null hypothesis: There is no difference in proportion of participants that go from HIV RNA ≥ 20 copies/mL to HIV RNA < 20 copies/mL between baseline to Week 12 in the AdhereTech bottle group compared the routine counseling group.|
1584665|NCT03772327|2913702|Superiority||Median Difference (Net)|-0.07||||0.328|2-Sided||||||Kruskal-Wallis|Log transformation of viral load|Difference of log viral load at Week 12 less the log viral load at baseline|Null hypothesis: Mean HIV viral load is not significantly different in the AdhereTech bottle group compared to the routine counseling only group.|
1584666|NCT03772327|2913703|Equivalence|Equivalence defined if a two-sided 2 sample proportion test accepts the null hypothesis with p > 0.05.|Difference in proportions|0.045||||0.89|2-Sided|95.0|-0.179|0.27|||Chi-squared, Corrected|degrees of freedom = 1|This is the proportion of those completing a week 12 visit less those completing a week 0 visit.|The null hypothesis is that the proportion of randomized participants that complete a week 12 visit is not lower in the AdhereTech bottle arm.|
1584667|NCT03772327|2913704|Superiority||Mean Difference (Net)|0.333||||0.07|2-Sided|95.0|-0.028|0.694|||t-test, 2 sided|A ratio of Week 12 to baseline TFV-DP levels was used rather than a raw difference as a ratio was normally distributed.|The mean difference is mean ratio (Week 12 TFV-DP level over the Week 0 TFV-DP level) in the Routine counseling + AdhereTech bottle arm less the mean ratio in the Routine counseling arm.|The power calculation was based on a null hypothesis of no difference in mean tenofovir-diphosphate (TFV-DP) concentrations between baseline versus week 12. Expected baseline mean (SD): 900 (404) fmol/punch. 12 week mean (SD): 1332 (597) fmol/punch in the AdhereTech bottle arm vs. 900 (404) fmol/punch in control arm. Type 1 error = 0.05, power = 80%, a sample size of 32 per arm (64 total) based on a two-sided t-test with equal variance.|
1584668|NCT03771560|2913705|Other||Mean Difference (Final Values)|-0.8||||0.69|2-Sided|95.0|-5.2|3.5|||Paired Sample t-test|||The parent-reported change in mean PedsQL total score from baseline to week 12.|
1584669|NCT03771560|2913706|Other||Median Difference (Final Values)|-0.5||||0.95|2-Sided|95.0|-7.0|13.5|||Wilcoxon (Mann-Whitney)|||The teacher-reported change in mean SRS total score from baseline to week 12.|
1584670|NCT03771560|2913707|Other||Mean Difference (Final Values)|-7.8||||0.095|2-Sided|95.0|-17.3|1.6|||Paired Sample t-test|||The parent-reported change in mean SRS total score from baseline to week 12.|
1584671|NCT03771560|2913708|Other||Mean Difference (Final Values)|1.2||||0.68|2-Sided|95.0|-5.2|7.6|||Paired Sample t-test|||The teacher-reported change in mean ABC total score from baseline to week 12.|
1584672|NCT03771560|2913709|Other||Mean Difference (Final Values)|-2.4||||0.56|2-Sided|95.0|-11.3|6.4|||Paired Sample t-test|||The parent-reported change in mean ABC total score from baseline to week 12.|
1584673|NCT03765502|2913719|Superiority||||||<|0.0001|||||||McNemar|Crossover design: paired test|||
1584674|NCT03765502|2913720|Superiority||||||<|0.0001|||||||McNemar|Crossover design: paired test|||
1584675|NCT03764813|2913724|Superiority||||||<|0.0001|||||||Kruskal-Wallis|||Group comparison is carried out among HbF values grouped according to the transfusion regimen (only cord blood transfusions, only adult transfusions, both cord and adult transfusions).|
1584676|NCT03764813|2913725|Superiority||Median Difference (Final Values)|0.537|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1584677|NCT03764813|2913726|Superiority||Median Difference (Final Values)|0.165|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1584678|NCT03764813|2913727|Superiority||||||<|0.0001|||||||Kruskal-Wallis|||Group comparison is carried out among HbF values grouped according to the transfusion regimen (only cord blood transfusions, only adult transfusions, both cord and adult transfusions).|
1584679|NCT03763058|2913770|Superiority||Mean Difference (Final Values)|-4.15|Standard Deviation|5.1|<|0.001|2-Sided|95.0|||||Sign test|||Total HAD score|
1584680|NCT03763058|2913771|Superiority||Mean Difference (Final Values)|-3.65|Standard Deviation|4.59|<|0.001|2-Sided|95.0|||||Sign test||||
1584681|NCT03763058|2913772|Superiority||Mean Difference (Final Values)|-1.2|Standard Deviation|2.71||0.045|2-Sided|95.0|||||Sign test||||
1584682|NCT03763058|2913773|Superiority||Mean Difference (Final Values)|-5.45|Standard Deviation|15.52||0.002|2-Sided|95.0|||||Sign test||||
1584683|NCT03763058|2913774|Superiority||Mean Difference (Final Values)|-2.8|Standard Deviation|4.19||0.012|2-Sided|95.0|||||Sign test||||
1584684|NCT03762668|2913775|Non-Inferiority|Noninferiority in VA was declared if the Upper Confidence Limit was less than 0.05.|Least Squares Mean Difference|0.0|Standard Error of the Mean|0.005|||1-Sided|95.0||0.01|||||test minus control||
1584685|NCT03742271|2913831|Superiority|Superiority was concluded in the lower limit of the 95% confidence interval was above 0.50.|Proportion|0.974|||||2-Sided|95.0|0.925|0.995||||||This study was powered to test the hypothesis that at least 50% will have an acceptable lens fitting.|
1584686|NCT03739242|2913840|Superiority||Least Square Mean difference|1.71||||0.7224|2-Sided|95.0|-7.83|11.25|||ANCOVA||||
1584687|NCT03739242|2913841|Superiority||Least Square Mean difference|-0.21||||0.1499|2-Sided|95.0|-0.49|0.08|||ANCOVA||||
1584688|NCT03739242|2913842|Superiority||Least Square Mean difference|0.003||||0.8476|2-Sided|95.0|-0.039|0.032|||ANCOVA||||
1584691|NCT03739242|2913845|Superiority||Least Square Mean difference|-0.07||||0.9266|2-Sided|95.0|-1.63|1.48|||ANCOVA||||
1584692|NCT03739242|2913846|Superiority||Least Square Mean difference|0.74||||0.5594|2-Sided|95.0|-1.76|3.24|||ANCOVA||||
1584693|NCT03739242|2913847|Superiority||Least Square Mean difference|-3.47||||0.4535|2-Sided|95.0|-12.64|5.7|||ANCOVA||||
1584694|NCT03739242|2913848|Superiority||Least Square Mean difference|-0.82|||<|0.0001|2-Sided|95.0|-1.05|-0.59|||ANCOVA||||
1584695|NCT03739242|2913849|Superiority||Least Square Mean difference|-0.91|||<|0.0001|2-Sided|95.0|-1.19|-0.62|||ANCOVA||||
1584696|NCT03739242|2913850|Superiority||Least Square Mean difference|-17.26|||<|0.0001|2-Sided|95.0|-23.54|-10.98|||ANCOVA||||
1584697|NCT03739242|2913851|Superiority||Least Square Mean difference|-7.0||||0.1924|2-Sided|95.0|-17.59|3.59|||ANCOVA||||
1584698|NCT03739242|2913852|Superiority||Least Square Mean difference|-41.7|||<|0.0001|2-Sided|95.0|-51.58|-31.82|||ANCOVA||||
1584699|NCT03739242|2913853|Superiority||Least Square Mean difference|0.09||||0.951|2-Sided|95.0|-2.87|3.05|||ANCOVA||||
1584700|NCT03739242|2913854|Superiority||Least Square Mean difference|-41.24||||0.0001|2-Sided|95.0|-51.73|-30.74|||ANCOVA||||
1584701|NCT03739242|2913855|Superiority||Least Square Mean difference|-39.16|||<|0.0001|2-Sided|95.0|-48.57|-29.75|||ANCOVA||||
1584702|NCT03735862|2913864|Superiority||||||<|0.0001|||||||McNemar|||Difference between baseline and follow-up|
1584703|NCT03735862|2913865|Other|Paired t-Test|||||<|0.001|||||||t-test, 1 sided|||Difference between baseline and follow-up|
1584704|NCT03733899|2913868|Superiority|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|-12.4|Standard Error of the Mean|4.22|||2-Sided|95.0|-20.9|-3.9|||||||mean difference was calculated as postremoval minus pre-insertion with Test and corneal region.
1584705|NCT03733899|2913869|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Mean Difference (Final Values)|7.4|Standard Error of the Mean|6.17|||2-Sided|95.0|-4.9|19.6||||||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin: 5-mintues post treatment - Pre Treatment.
1584706|NCT03733899|2913869|Superiority|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|2.9|Standard Error of the Mean|6.19|||2-Sided|95.0|-9.3|15.2||||||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin: 10-mintues post treatment - Pre Treatment.
1584707|NCT03733899|2913869|Superiority|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|7.8|Standard Error of the Mean|6.1|||2-Sided|95.0|-4.9|19.9||||||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin: 5-mintues post treatment - Pre Treatment.
1584708|NCT03733899|2913869|Superiority|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|0.8|Standard Error of the Mean|6.12|||2-Sided|95.0|-11.4|12.9||||||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin: 10-mintues post treatment - Pre Treatment.
1584709|NCT03733899|2913870|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Mean Difference (Final Values)|11.2|Standard Error of the Mean|4.82|||2-Sided|95.0|1.6|20.8||||||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin
1584710|NCT03733899|2913870|Superiority|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|6.8|Standard Error of the Mean|5.12|||2-Sided|95.0|-3.5|17.0||||||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Upper Lid Margin
1584711|NCT03733899|2913870|Superiority|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|8.5|Standard Error of the Mean|4.77|||2-Sided|95.0|-1.0|18.0||||||5-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin
1584712|NCT03733899|2913870|Superiority|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0.|Mean Difference (Final Values)|1.4|Standard Error of the Mean|5.07|||2-Sided|95.0|-8.7|11.6||||||10-Minutes Post Treatment|Mean Difference was cacluated as Corneal - Lower Lid Margin
1584713|NCT03733899|2913871|Superiority|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-8.2|Standard Error of the Mean|4.25|||2-Sided|95.0|-16.7|0.2||||||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).
1584714|NCT03733899|2913871|Superiority|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-12.3|Standard Error of the Mean|4.15|||2-Sided|95.0|-20.6|-4.1||||||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).
1584715|NCT03733899|2913871|Superiority|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-9.6|Standard Error of the Mean|4.14|||2-Sided|95.0|-17.8|-1.4||||||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).
1584716|NCT03733899|2913871|Superiority|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-16.4|Standard Error of the Mean|4.04|||2-Sided|95.0|-24.4|-8.3||||||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).
1584717|NCT03733899|2913871|Superiority|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-4.3|Standard Error of the Mean|4.85|||2-Sided|95.0|-13.9|5.3||||||10-Minutes Post Treatment|Mean difference was calculated as (10-min Post-Treatment MINUS Immediate Post-insertion).
1585108|NCT03614975|2914999|Other|||||||0.42||||||Vaccine Strain: A/H3N2: Day 0|Chi-squared||||
1591285|NCT03135015|2926023|Other|||||||0.5016|||||||t-test, 2 sided||||
1584718|NCT03733899|2913871|Superiority|Superiority was concluded if the lower limit of 95% confidence interval was greater than 0 for at least one of the three ocular regions (upper lid margin, lower lid margin, or cornea).|Mean Difference (Final Values)|-4.0|Standard Error of the Mean|4.61|||2-Sided|95.0|-13.2|5.1||||||5-Minutes Post Treatment|Mean difference was calculated as (5-min Post-Treatment MINUS Immediate Post-insertion).
1584719|NCT03733899|2913872|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-sqaure Mean Difference|7.6|Standard Error of the Mean|5.67|||2-Sided|95.0|-3.7|18.8|||||difference was calculated as Test - Placebo.|10-Mintues Post Treatment|
1584720|NCT03733899|2913872|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.9|Standard Error of the Mean|5.76|||2-Sided|95.0|-8.5|14.3|||||Difference was calculated as Test - Placebo.|5-Mintues Post Treatment|
1584721|NCT03733899|2913872|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.4|Standard Error of the Mean|5.83|||2-Sided|95.0|-9.2|14.0|||||Difference was calculated as Test - Placebo.|10-Mintues Post Treatment|
1584722|NCT03733899|2913872|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|0.3|Standard Error of the Mean|5.92|||2-Sided|95.0|-11.4|12.1|||||difference was calculated as Test - Placebo.|5-Minutes Post Treatment|
1584723|NCT03733899|2913872|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|0.4|Standard Error of the Mean|6.3|||2-Sided|95.0|-12.1|12.9|||||Difference was calculated as Test - Placebo|10-Minutes Post Treatment|
1584724|NCT03733899|2913872|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|2.1|Standard Error of the Mean|6.22|||2-Sided|95.0|-10.3|14.4|||||Difference was calculated as Test - Placebo|5-Mintues Post Treatment|
1584725|NCT03733899|2913873|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-sqaure Mean Difference|7.7|Standard Error of the Mean|4.54|||2-Sided|95.0|-1.4|16.8|||||difference was calculated as Test - Placebo.|10-Mintues Post Treatment|
1584726|NCT03733899|2913873|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|3.0|Standard Error of the Mean|4.37|||2-Sided|95.0|-5.7|11.7|||||Difference was calculated as Test - Placebo.|5-Mintues Post Treatment|
1584727|NCT03733899|2913873|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|2.9|Standard Error of the Mean|4.67|||2-Sided|95.0|-6.5|12.2|||||Difference was calculated as Test - Placebo.|10-Mintues Post Treatment|
1584728|NCT03733899|2913873|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|0.8|Standard Error of the Mean|4.67|||2-Sided|95.0|-8.2|9.8|||||difference was calculated as Test - Placebo.|5-Minutes Post Treatment|
1584729|NCT03733899|2913873|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-square Mean Difference|0.9|Standard Error of the Mean|5.3|||2-Sided|95.0|-9.6|11.5|||||Difference was calculated as Test - Placebo|10-Minutes Post Treatment|
1584730|NCT03733899|2913873|Superiority|Subjective comfort was analyzed using linear mixed model. Statistical inference was made based on the 95% confidence interval constructed for the least square mean difference.|Least-Square Mean Difference|2.6|Standard Error of the Mean|4.96|||2-Sided|95.0|-7.3|12.4|||||Difference was calculated as Test - Placebo|5-Mintues Post Treatment|
1584731|NCT03733470|2913874|Other||||||<|0.05|||||||t-test, 2 sided||||
1584732|NCT03727854|2913877|Superiority|||||||0.639|||||||t-test, 2 sided||||
1584733|NCT03727854|2913878|Superiority|||||||0.652|||||||t-test, 2 sided||||
1584734|NCT03727854|2913879|Superiority|||||||0.551|||||||t-test, 2 sided||||
1584735|NCT03727854|2913880|Superiority|||||||0.74|||||||t-test, 2 sided||||
1584736|NCT03727854|2913881|Superiority|||||||0.823|||||||t-test, 2 sided||||
1584737|NCT03727854|2913882|Superiority|||||||0.617|||||||t-test, 2 sided||||
1584738|NCT03727854|2913883|Superiority|||||||0.608|||||||t-test, 2 sided||||
1584739|NCT03727854|2913884|Superiority|||||||0.971|||||||t-test, 2 sided||||
1584740|NCT03727854|2913885|Superiority|||||||0.933|||||||t-test, 2 sided||||
1584741|NCT03724981|2913909|Superiority||||||<|0.0001|||||||Prescott test||||
1584742|NCT03724981|2913910|Superiority||||||<|0.0001|||||||Prescott test||||
1584743|NCT03724877|2913911|Other||Adjusted rate ratio|0.94|||||2-Sided|95.0|0.7|1.28|||||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|Severe exacerbation|
1584744|NCT03724877|2913911|Other||Adjusted rate ratio|0.93|||||2-Sided|95.0|0.83|1.04|||||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.|Moderate/ sever exacerbation|
1584745|NCT03724877|2913912|Other||Adjusted HR|1.46|||||2-Sided|95.0|1.03|2.07|||||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.||
1585109|NCT03614975|2914999|Other|||||||0.16||||||Vaccine Strain: A/H1N1: Day 21|Chi-squared||||
1585110|NCT03614975|2914999|Other|||||||0.42||||||Vaccine Strain: A/H1N1:Day 0|Chi-squared||||
1584746|NCT03724877|2913913|Other||Adjusted HR|0.97|||||2-Sided|95.0|0.87|1.09|||||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted FEV1.||
1584747|NCT03724877|2913914|Other||Adjusted hazard ratio (HR)|1.04|||||2-Sided|95.0|0.79|1.38|||||After matching on high-dimensional propensity scores, sex prior severe exacerbation, prior maintenance treatment and calendar time, adjusted further for the deciles of propensity score and percent predicted forced expiratory volume1 (FEV1).||
1584748|NCT03723980|2913915|Other|||||||0.17||||||"The p-value calculated is for pain score difference at day 4~Threshold for statistical significance= <0.05"|Kruskal-Wallis||||
1584749|NCT03723980|2913915|Other|||||||0.55||||||"The p-value calculated is for pain score difference at day 3~Threshold for statistical significance= <0.05"|Kruskal-Wallis||||
1584750|NCT03723980|2913915|Other|||||||0.13||||||"The p-value calculated is for pain score difference at day 2~Threshold for statistical significance= <0.05"|Kruskal-Wallis||||
1584751|NCT03723980|2913915|Other|||||||0.36||||||"The p-value calculated is for pain score difference at 12 hours~Threshold for statistical significance= <0.05"|Kruskal-Wallis||||
1584752|NCT03723980|2913915|Other|||||||0.15||||||"The p-value calculated is for pain score difference at 4 hours~Threshold for statistical significance= <0.05"|Kruskal-Wallis||||
1584753|NCT03723980|2913916|Other||Median Difference (Net)|4.3||||0.02|2-Sided|||||"The p-value calculated is for pain score difference at Day 4.~Threshold for statistical significance= <0.05"|Wilcoxon (Mann-Whitney)||||
1584754|NCT03723980|2913916|Other||Mean Difference (Net)|4.4||||0.023|2-Sided|||||"The p-value calculated is for pain score difference at Day 3~Threshold for statistical significance= <0.05"|Wilcoxon (Mann-Whitney)||||
1584755|NCT03723980|2913916|Other||Mean Difference (Net)|5.5||||0.035|2-Sided|||||"The p-value calculated is for pain score difference at Day 2~Threshold for statistical significance= <0.05"|Wilcoxon (Mann-Whitney)||||
1584756|NCT03723980|2913916|Other||Mean Difference (Net)|2.8||||0.94|2-Sided|||||"The p-value calculated is for pain score difference at 12 hours~Threshold for statistical significance= <0.05"|Wilcoxon (Mann-Whitney)||||
1584757|NCT03723980|2913916|Other||Mean Difference (Net)|-0.6||||0.412|2-Sided|||||"The p-value calculated is for pain score difference at 4 hours~Threshold for statistical significance= <0.05"|Wilcoxon (Mann-Whitney)||||
1584758|NCT03723980|2913917|Other||Mean Difference (Net)|0.77|Standard Error of the Mean|2.9||0.796|2-Sided|95.0||||"The calculated p value is for the difference between time intervals of day 3 and day 4~Threshold for statistical significance= <0.05"|ANOVA||||
1584759|NCT03723980|2913917|Other||Mean Difference (Net)|1.69|Standard Error of the Mean|2.9||0.574|2-Sided|95.0||||"The calculated p value is for the difference between time intervals of day 2 and day 3~Threshold for statistical significance= <0.05"|ANOVA||||
1584760|NCT03723980|2913917|Other||Mean Difference (Net)|5.23|Standard Error of the Mean|2.9||0.8|2-Sided|95.0||||"The calculated p value is for the difference between time intervals of 12 hours and day 2~Threshold for statistical significance= <0.05"|ANOVA||||
1584761|NCT03723980|2913917|Other||Mean Difference (Net)|-1.54|Standard Error of the Mean|2.9||0.605|2-Sided|95.0||||"The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours~Threshold for statistical significance= <0.05"|ANOVA||||
1584762|NCT03723980|2913917|Other||Mean Difference (Net)|11.8|Standard Error of the Mean|2.9||0|2-Sided|95.0||||"The calculated p value is for the difference between pre-operative time interval and 4 hours time interval~Threshold for statistical significance= <0.05"|ANOVA||||
1584763|NCT03723980|2913917|Other||Mean Difference (Net)|0.67|Standard Error of the Mean|3.0||0.828|2-Sided|95.0||||"The calculated p value is for the difference between time intervals of day 3 and day 4~Threshold for statistical significance= <0.05"|ANOVA||||
1584764|NCT03723980|2913917|Other||Mean Difference (Net)|0.94|Standard Error of the Mean|3.0||0.76|2-Sided|95.0||||"The calculated p value is for the difference between time intervals of day 2 and day 3~Threshold for statistical significance= <0.05"|ANOVA||||
1584765|NCT03723980|2913917|Other||Mean Difference (Net)|5.88|Standard Error of the Mean|3.0||0.056|2-Sided|95.0||||"The calculated p value is for the difference between time intervals of 12 hours and day 2~Threshold for statistical significance= <0.05"|ANOVA||||
1584766|NCT03723980|2913917|Other||Mean Difference (Net)|2.33|Standard Error of the Mean|3.0||0.448|2-Sided|95.0||||"The calculated p value is for the difference between time interval of 4 hours and time interval of 12 hours.~Threshold for statistical significance= <0.05"|ANOVA||||
1584767|NCT03723980|2913917|Other||Mean Difference (Net)|2.97|Standard Error of the Mean|3.0||0.334|2-Sided|95.0||||"The calculated p value is for the difference between pre-operative time interval and 4 hours time interval.~Threshold for statistical significance= <0.05"|ANOVA||||
1584768|NCT03723980|2913919|Superiority||Mean Difference (Net)|-0.72||||0.813|2-Sided|95.0||||"The calculated p value is for time interval of day 4~threshold for statistical significance= <0.05"|ANOVA||||
1584769|NCT03723980|2913919|Superiority||Mean Difference (Net)|-0.82||||0.786|2-Sided|95.0||||"The calculated p value is for time interval of day 3~threshold for statistical significance= <0.05"|ANOVA||||
1584770|NCT03723980|2913919|Superiority||Mean Difference (Net)|-1.57||||0.605|2-Sided|95.0||||"The calculated p value is for time interval of day 2~threshold for statistical significance= <0.05"|ANOVA||||
1584771|NCT03723980|2913919|Superiority||Mean Difference (Net)|-0.92||||0.764|2-Sided|95.0||||"The calculated p value is for time interval of 12 hours~threshold for statistical significance= <0.05"|ANOVA||||
1584772|NCT03723980|2913919|Superiority||Mean Difference (Net)|2.96||||0.329|2-Sided|95.0||||"the calculated p value is for time interval of 4 hours~threshold for statistical significance= <0.05"|ANOVA|For multiple comparisons between groups, post hoc (LSD) was applied|||
1584773|NCT03720938|2913928|Superiority|||||||0.543|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from training category.|
1584774|NCT03720938|2913929|Superiority|||||||0.247|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from aerobic category.|
1585111|NCT03614975|2915000|Other|||||||0.23||||||B/Phuket|Chi-squared||||
1585112|NCT03614975|2915000|Other|||||||0.64||||||B/Colorado|Chi-squared||||
1584775|NCT03720938|2913930|Superiority|||||||0.843|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the active video game group for the variable of enjoyment from balance category.|
1584776|NCT03720938|2913931|Superiority|||||||0.809|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was the absence of difference between the two genders in the Active video game group for the variable of enjoyment from sports category.|
1584777|NCT03720938|2913932|Superiority|||||||0.194||||||Tested the significance of gender between genders|Wilcoxon (Mann-Whitney)|||"Enjoyment scale of physical activity sports in intervention group between male and female genders"|
1584778|NCT03720938|2913933|Superiority|||||||0.00238||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.|
1584779|NCT03720938|2913933|Superiority|||||||0.002||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.|
1584780|NCT03720938|2913933|Superiority|||||||0.002879||||||The outcome of self-perception for global self-worth was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for global self-worth at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global self-worth.|
1584781|NCT03720938|2913934|Superiority|||||||0.00603||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.|
1584782|NCT03720938|2913934|Superiority|||||||0.005||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.|
1584783|NCT03720938|2913934|Superiority|||||||0.007061||||||The outcome of self-perception of global physical self-worth was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for global physical self-worth at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of global physical self-worth.|
1584784|NCT03720938|2913935|Superiority|||||||0.6328||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.|
1584785|NCT03720938|2913935|Superiority|||||||0.632||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.|
1584786|NCT03720938|2913935|Superiority|||||||0.638505||||||The outcome of self-perception for body attractiveness was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for body attractiveness at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of body attractiveness.|
1584787|NCT03720938|2913936|Superiority|||||||0.0534||||||The outcome of self-perception for strength competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.|
1584788|NCT03720938|2913936|Superiority|||||||0.051||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.|
1584789|NCT03720938|2913936|Superiority|||||||0.058102||||||The outcome of self-perception for strength competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for strength competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of strength competence.|
1584790|NCT03720938|2913937|Superiority|||||||0.08818||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|
1584791|NCT03720938|2913937|Superiority|||||||0.085||||||The outcome of self-perception for physical condition competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of physical condition competence.|
1584884|NCT03693989|2914138|Other|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.497|||||||Fisher Exact|||foreign body sensation eyes comparison|
1591286|NCT03135015|2926023|Other|||||||0.0509|||||||t-test, 2 sided||||
1584792|NCT03720938|2913937|Superiority|||||||0.094||||||The outcome of self-perception for physical condition competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for physical condition competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of physical condition competence.|
1584793|NCT03720938|2913938|Superiority|||||||0.60938||||||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|Linear mixed-effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of sports competence.|
1584794|NCT03720938|2913938|Superiority|||||||0.608||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||The outcome of self-perception for sports competence was tested for any difference between groups by linear mixed-effects model analysis.|
1584795|NCT03720938|2913938|Superiority|||||||0.615648||||||The outcome of self-perception for sports competence was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for self-perception for sports competence at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable self-perception of sports competence.|
1584796|NCT03720938|2913939|Superiority|||||||0.006602||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.|
1584797|NCT03720938|2913939|Superiority|||||||0.006||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.|
1584798|NCT03720938|2913939|Superiority|||||||0.008||||||The outcomes of auditory reaction time of non-dominant hand was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the auditory reaction time of non-dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of non-dominant hand.|
1584799|NCT03720938|2913940|Superiority|||||||3.67e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.|
1584800|NCT03720938|2913940|Superiority|||||||1.633e-05||||||The outcomes of auditory reaction time of dominant hand was tested for any difference between groups by linear mixed-effects analysis.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.|
1584801|NCT03720938|2913940|Superiority|||||||0||||||The outcomes of auditory reaction time of dominant hand was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the auditory reaction time of dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable auditory reaction time of dominant hand.|
1584802|NCT03720938|2913941|Superiority|||||||55||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.|
1584803|NCT03720938|2913941|Superiority|||||||9e-08||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.|
1584804|NCT03720938|2913941|Superiority|||||||0||||||The outcome of visual reaction time of non-dominant hand was tested for any difference between groups.|ANCOVA|Adjusted for the visual reaction time of non-dominant hand at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time of non-dominant hand.|
1584805|NCT03720938|2913942|Superiority||||||‬|2.82e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time.|
1584806|NCT03720938|2913942|Superiority|Adjusted for the weight at baseline and confounding variable age.|||||‬|1.196e-05||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||The outcome of visual reaction time was tested for any difference between groups by linear mixed-effects model analysis.|
1584807|NCT03720938|2913942|Superiority||||||‬|0||||||The outcome of visual reaction time was tested for any difference between groups by covariate analysis.|ANCOVA|Adjusted for the weight at baseline and confounding variable age.||Null hypothesis was the absence of difference between the two groups for the dependent variable visual reaction time.|
1584808|NCT03720938|2913943|Superiority|||||||0.250006||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.|
1584809|NCT03720938|2913943|Superiority|||||||0.22||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.|
1584810|NCT03720938|2913943|Superiority|||||||0.259||||||The outcomes of fat ratio was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the fat ratio at baseline and confounding variable age.|ANCOVA|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable fat ratio.|
1584811|NCT03720938|2913944|Superiority|||||||0.000235||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body index z score.|
1584812|NCT03720938|2913944|Superiority|||||||0.0001402||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index z score.|
1584813|NCT03720938|2913944|Superiority|||||||0||||||The outcome of body mass index z score was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the body mass index z score at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index z score.|
1584814|NCT03720938|2913945|Superiority|||||||3.67e-06||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.|
1584815|NCT03720938|2913945|Superiority|||||||3.06e-06||||||"Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.~Adjusted for cluster effect, and small sample sizes, baseline value and age."|Linear mixed effects model|Satterthwaite’s correction method for denominator degrees of freedom.||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.|
1584816|NCT03720938|2913945|Superiority|||||||0||||||The outcomes of weight was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the body mass index at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable body mass index.|
1584817|NCT03720938|2913946|Superiority|||||||0.00386||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality. Adjusted by Satterthwaite’s degrees of freedom correction method for cluster effect, and small sample sizes in addition to baseline value and age.|
1584818|NCT03720938|2913946|Superiority|||||||0.002||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight z score.|
1584819|NCT03720938|2913946|Superiority|||||||0.005||||||The outcome of weight z score was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the weight at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable weight z scores.|
1584820|NCT03720938|2913947|Superiority|||||||0.000397||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed-effects model|Adjusted by Satterthwaite’s degrees of freedom method for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.|
1584821|NCT03720938|2913947|Other|||||||0.0002535||||||Linear mixed-effects model fit by maximum likelihood since restricted maximum likelihood assumes a strong normality.|Linear mixed effects model|Adjusted for cluster effect, and small sample sizes in addition to baseline value and age.||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.|
1584822|NCT03720938|2913947|Superiority|A sample size of 26 children per group was needed with the assumption of Cohen’s d = 0.8, the alpha error of 0.05 and a power of 80%.||||||0.001||||||The outcomes of weight was tested for any difference between groups by covariate analysis (ANCOVA) adjusted for the weight at baseline and confounding variable age.|ANCOVA|||Null hypothesis was the absence of difference between the two groups for the dependent variable weight.|
1584823|NCT03720847|2913948|Superiority||Mean Difference (Final Values)|-1.32||||0.23|2-Sided||||||t-test, 2 sided|||paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|
1584824|NCT03720847|2913949|Superiority||Mean Difference (Final Values)|-1.16||||0.25|2-Sided||||||t-test, 2 sided|||paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|
1584825|NCT03720847|2913950|Superiority||Mean Difference (Final Values)|1.04||||0.073|2-Sided||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|
1584826|NCT03720847|2913951|Superiority||Mean Difference (Final Values)|3.65||||0.018|2-Sided||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual change in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|
1584885|NCT03693989|2914138|Other|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.489|||||||Fisher Exact|||Itching eyes comparison|
1585113|NCT03614975|2915000|Other|||||||0.64||||||A/H3N2|Chi-squared||||
1584827|NCT03720847|2913952|Superiority||Mean Difference (Final Values)|3.16||||0.013|2-Sided||||||t-test, 2 sided||Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|
1584828|NCT03720847|2913953|Superiority||Mean Difference (Final Values)|0.21||||0.03|2-Sided||||||t-test, 2 sided|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|Positive estimated value indicates a greater perimenstrual increase in the outcome in the placebo condition relative to the active condition.|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|
1584829|NCT03720847|2913954|Superiority||Mean Difference (Final Values)|0.26||||0.012|2-Sided||||||t-test, 2 sided|paired sample t-test comparing perimenstrual change in the placebo vs. active conditions within a given participant.|Positive estimated value indicates greater perimenstrual increase in symptoms in the placebo condition relative to the active condition.||
1584830|NCT03720119|2913956|Other|Analysis of Variance for repeated measurements.|day effect F|27.83||||0.0001|2-Sided|||||The calculated P-Value represents the repeated measurement/Day (all times versus Day 1)|Dunnett's post-hoc test||||
1584831|NCT03714672|2914030|Superiority||Mean Difference (Final Values)|-2.8|||<|0.0001|2-Sided|95.0|-3.5|-2.1|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results. The planned test was a test for non-inferiority.|
1584832|NCT03714672|2914030|Superiority||Mean Difference (Final Values)|-3.2|||<|0.0001|2-Sided|95.0|-3.9|-2.5|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results. The planned test was a test for non-inferiority.|
1584833|NCT03714672|2914030|Superiority||Mean Difference (Final Values)|-4.5|||<|0.0001|2-Sided|95.0|-5.2|-3.8|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results.|
1584834|NCT03714672|2914030|Superiority||Mean Difference (Final Values)|-4.1|||<|0.0001|2-Sided|95.0|-4.8|-3.4|||ANCOVA|ANCOVA model with treatment, baseline pain intensity, and site as covariates.|LS means, 95% CIs, and pairwise CIs and p-values comparing the combination treatment arm to the monotherapy arm.|Bonferroni-Holm procedure used for determining the statistical significance of the results.|
1584835|NCT03709823|2914035|Superiority||LS Mean Difference vs. Placebo|-9.3||||0.0518|2-Sided|95.0|-18.667|0.075||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA||||
1584836|NCT03709823|2914035|Superiority||LS Mean Difference vs. Placebo|-12.41||||0.0091|2-Sided|95.0|-21.695|-3.135||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA||||
1584837|NCT03709823|2914036|Superiority||LS Mean Difference vs. Placebo|-16.2||||0.0003|2-Sided|95.0|-24.862|-7.548||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA||||
1584838|NCT03709823|2914036|Superiority||LS Mean Difference vs. Placebo|-14.61||||0.001|2-Sided|95.0|-23.216|-6.009||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA||||
1584839|NCT03709823|2914037|Superiority||LS Mean Difference vs. Commercial Sched.|-12.17||||0.1025|2-Sided|95.0|-26.869|2.535||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA||||
1584840|NCT03709823|2914037|Superiority||LS Mean Difference vs. Placebo|-2.81||||0.6018|2-Sided|95.0|-13.438|7.82||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA||||
1584841|NCT03709823|2914037|Superiority||LS Mean Difference vs. Placebo|-5.9||||0.2708|2-Sided|95.0|-16.463|4.66||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA||||
1584842|NCT03709823|2914037|Superiority||LS Mean Difference vs. Placebo|-22.07|||<|0.0001|2-Sided|95.0|-32.791|-11.342||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA||||
1584843|NCT03709823|2914037|Superiority||LS Mean Difference vs. Placebo|-20.48|||<|0.0002|2-Sided|95.0|-31.141|-9.821||Based on analysis of variance models with percent of expected cigarettes smoked as the dependent variable, treatment and body mass index class as main fixed effects, with covariate of baseline cigarettes.|ANOVA||||
1584844|NCT03709810|2914042|Superiority||Geometric Mean Ratio|0.19|||<|0.0001|2-Sided|95.0|0.12|0.3|||ANOVA|Log10 peanuts mass as response variable, study product and period as fixed explanatory effects, and participant as a random effect.|GMR=(Experimental denture adhesive/ No Adhesive)||
1584845|NCT03708770|2914046|Other|No power calculation was performed for this study.||||||||||||||||"This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Primary Patency endpoint was calculated using a Kaplan-Meier analysis."|The primary patency rate was determined via Kaplan-Meier methods.
1584846|NCT03708770|2914047|Other|No power calculation was performed for this study.||||||||||||||||"This was not a hypothesis-driven study. Therefore, there were no primary effectiveness or safety endpoints.~The Secondary Patency endpoint was calculated using a Kaplan-Meier analysis."|The Secondary Patency rate was determined via Kaplan-Meier methods.
1585056|NCT03628885|2914896|Superiority||||||=|0||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P<.05|ANOVA||||
1584847|NCT03707821|2914065|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|8.03|Standard Deviation|2.295|||2-Sided|95.0|3.48|12.54|||||Mean difference was calculated as Test minus Control.|Sample Size was based on primary endpoints only.|
1584848|NCT03707821|2914066|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|2.5|Standard Deviation|1.94|||2-Sided|95.0|-1.3|6.3|||||Mean difference was calculated as Test minus Control.|Sample Size was based on primary endpoints only.|
1584849|NCT03707821|2914067|Non-Inferiority|A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Difference (Final Values)|0.0|Standard Deviation|0.0036|||2-Sided|95.0|-0.007|0.008|||||mean difference was calculated as Test minus Control.|It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.|
1584850|NCT03707821|2914068|Superiority|A superiority margin of 90% was used. Lower limit of 95% credible interval was compared to 90%|Mean Percentage of Acceptable Fitting|99.5|Standard Deviation|0.38|||2-Sided|95.0|98.5|100.0||||||It was calculated that 100 participants were required to show that the acceptable lens fitting for the Test lens would be superior to 90% with at least 80% power. Sample size was determined using simulations methods for repeated measures.|
1584851|NCT03707821|2914069|Non-Inferiority|A non-inferiority margin of 0.05 points was used. This margin corresponds to a half line difference.|Mean Difference (Final Values)|-0.03|Standard Deviation|0.008|||2-Sided|95.0|-0.04|-0.01|||||Mean difference was calculated as Test minus Control.|It was calculated that 30 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.|
1584852|NCT03707821|2914070|Non-Inferiority|A cumulative odds ratio non-inferiority margin of 2 was used. This margin is based on a 10% difference if the proportion of subjects that report a higher rating/experience.|Mean Difference (Final Values)|0.08|Standard Deviation|0.034|||2-Sided|95.0|0.02|0.15|||||mean difference was calculated as Test minus Control.|It was calculated that 40 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 10% difference in proportion of subjects that reported at higher rating (Strongly Agree and Agree) with the Test compared to the Control lens at the 2-week follow-up. Sample size was determined using simulation-based methods (alpha=0.05).|
1584853|NCT03707821|2914071|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores. Non-inferiority was declared in the lower limit of the 95% credible interval was above 5.|Mean Difference (Net)|3.3|Standard Deviation|2.65|||2-Sided|95.0|-2.0|8.5|||||Mean difference was calculated as Test minus Control.|It was calculated that 224 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect a 5 points difference in mean overall comfort at he 2-week follow-up. Sample size was determined using Stroup’s Method (alpha=0.05).|
1584854|NCT03706469|2914078|Equivalence|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|173.3|||||2-Sided|90.0|150.05|200.16|||||||
1584855|NCT03706469|2914078|Equivalence|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|99.8|||||2-Sided|90.0|84.94|117.27|||||||
1584856|NCT03706469|2914078|Equivalence|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|79.14|||||2-Sided|90.0|67.36|92.99|||||||
1584857|NCT03706469|2914079|Equivalence|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|172.7|||||2-Sided|90.0|149.07|200.09|||||||
1584858|NCT03706469|2914079|Equivalence|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|99.61|||||2-Sided|90.0|88.88|111.63|||||||
1584859|NCT03706469|2914079|Equivalence|Bioequivalence in the AUC∞ will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|84.29|||||2-Sided|90.0|73.92|96.11|||||||
1584860|NCT03706469|2914080|Equivalence|Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|172.73|||||2-Sided|90.0|152.55|195.58|||||||
1584861|NCT03706469|2914080|Equivalence|Bioequivalence in the AUClast will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of GMR|102.22|||||2-Sided|90.0|91.1|114.7|||||||
1584862|NCT03706469|2914080|Equivalence|Bioequivalence in the AUClast will be concluded if the 90 percent (%) confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|Percentage of Geometric Mean Ratio (GMR)|83.6|||||2-Sided|90.0|74.5|93.8|||||||
1584863|NCT03700671|2914111|Superiority||||||<|0.01||||||0.05 was used as a threshold for significance|ANOVA||||
1584864|NCT03700671|2914112|Superiority||||||<|0.01||||||A P-value of 0.05 was used as the threshold for significance|ANOVA|||A sample size of 38 using G*Power 3.1 software was calculated based on previously published data in which the mean difference between HIIT and moderate intensity continuous training (MICT) was 3.2 ml.kg-1.min-1 with a pooled standard deviation of 3 ml.kg-1.min-1. Statistical significance was set at = 0.05 and power set to 0.95. To allow for 10% attrition 42 individuals were recruited to the study|
1585114|NCT03614975|2915000|Other|||||||0.28||||||A/H1N1|Chi-squared||||
1584865|NCT03698591|2914113|Other||F-statistic|0.396||||0.535|2-Sided|||||A priori threshold of p < .05. This value reflects the test of the main effect of study arm.|ANOVA|||This analysis examined the effect of study arm specifically on distraction performance. The within-subjects factor was study arm, between-subjects factor was study arm order, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.|
1584866|NCT03698591|2914113|Other||F-statistic|3.196||||0.085|2-Sided|||||A priori threshold of p < .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.|
1584867|NCT03698591|2914113|Other||t-statistic|0.828||||0.415|2-Sided|||||A priori significance threshold of p < .05.|t-test, 2 sided|||A follow-up dependent-samples t-test was run to test the effect of study period on distraction effort.|
1584868|NCT03698591|2914113|Other||F-statistic|4.04||||0.054|2-Sided|||||P-value corresponds to the main effect of study period. A priori threshold of p < .05.|ANOVA|||A follow-up ANOVA was run with within-subjects factors of task condition and study period.|
1584869|NCT03698591|2914113|Other||F-statistic|0.031||||0.862|2-Sided|||||P-value corresponds to the two way interaction of task condition and study arm . A priori significance threshold of p < .05.|ANOVA|||The null hypothesis was that distraction self-reported effort would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.|
1584870|NCT03698591|2914114|Other||F-statistic|0.004||||0.948|2-Sided|||||A priori threshold of p < .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.|
1584871|NCT03698591|2914114|Other||t-statistic|1.282||||0.21|2-Sided|||||A priori significance threshold of p < .05.|t-test, 2 sided|||A dependent-samples t-test was used to compare distraction performance between study periods 1 and 2. The null hypothesis was that distraction performance would not differ by study period.|
1584872|NCT03698591|2914114|Other||F-statistic|5.911||||0.021|2-Sided|||||P-value corresponds to two-way interaction. A priori significance threshold of p < .05.|ANOVA|||This analysis evaluated the two-way interaction of task condition and study period. The null hypothesis was that distraction performance would not differ by study period. Within-subjects factors included task condition and study period.|
1584873|NCT03698591|2914114|Other||F-statistic|6.155||||0.019|2-Sided|||||P-value corresponds to 3 way interaction. A priori significance threshold of p < .05.|ANOVA|||The null hypothesis was that distraction performance would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.|
1584874|NCT03698591|2914115|Other||F-statistic|7.162||||0.013|2-Sided|||||A priori threshold of p < .05. This value reflects the test of the main effect of study arm.|ANOVA|||This analysis examined the effect of study arm specifically on distancing effort. The within-subjects factor was study arm, between-subjects factor was study arm order, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.|
1584875|NCT03698591|2914115|Other||F-statistic|3.196||||0.085|2-Sided|||||A priori threshold of p < .05. This value reflects the test of the main effect of study arm.|ANOVA|||Post-hoc analyses were used to explore treatment effects using covariates related to the treatment parameters. For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.|
1584876|NCT03698591|2914115|Other||t-statistic|2.694||||0.012|2-Sided|||||A priori significance threshold of p < .05.|t-test, 2 sided|||A follow-up dependent-samples t-test was run to test a potential effect of study period on distancing effort.|
1584877|NCT03698591|2914115|Other||F-statistic|4.04||||0.054|2-Sided|||||P-value corresponds to the main effect of study period. A priori threshold of p < .05.|ANOVA|||A follow-up ANOVA was run with within-subjects factors of task condition and study period.|
1584878|NCT03698591|2914115|Other||F-statistic|0.031||||0.862|2-Sided|||||P-value corresponds to the two way interaction of task condition and study arm . A priori significance threshold of p < .05.|ANOVA|||The null hypothesis was that distancing self-reported effort would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.|
1584879|NCT03698591|2914116|Other||F-statistic|0.004||||0.948|2-Sided|||||A priori threshold of p < .05. This value reflects the test of the main effect of study arm.|ANOVA|||For this analysis, study arm and task condition were used as within-subjects factors, study arm order was used as a between-subjects factor, and TMS stimulator intensity and brain-target-to-scalp distance were used as covariates.|
1584880|NCT03698591|2914116|Other||t-statistic|-1.656||||0.108|2-Sided|||||A priori significance threshold of p < .05.|t-test, 2 sided|||A dependent-samples t-test was used to compare distancing performance between study periods 1 and 2. The null hypothesis was that distancing performance would not differ by study period.|
1584881|NCT03698591|2914116|Other||F-statistic|5.911||||0.021|2-Sided|||||P-value corresponds to two-way interaction. A priori significance threshold of p < .05.|ANOVA|||This analysis evaluated the two-way interaction of task condition and study period. The null hypothesis was that distancing performance would not differ by study period. Within-subjects factors included task condition and study period.|
1584882|NCT03698591|2914116|Other||F-statistic|6.155||||0.019|2-Sided|||||P-value corresponds to 3 way interaction. A priori significance threshold of p < .05.|ANOVA|||The null hypothesis was that distancing performance would not differ by arm of the study. Within-subjects factors included task condition (distancing vs. distraction) and study arm. Study arm order was used as a between-subjects factor.|
1584883|NCT03693989|2914138|Other|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||1|||||||Fisher Exact|||blurred vision comparison|
1585057|NCT03628885|2914896|Superiority||||||<|0.02||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P<.05|ANOVA||||
1584886|NCT03693989|2914138|Other|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.346|||||||Fisher Exact|||burning eyes comparison|
1584887|NCT03693989|2914139|Other|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.045|||||||t-test, 2 sided||||
1584888|NCT03693989|2914140|Other|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.3|||||||Chi-squared, Corrected||||
1584889|NCT03693989|2914141|Other|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.047|||||||t-test, 2 sided||||
1584890|NCT03693989|2914142|Other|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.497|||||||Fisher Exact||||
1584891|NCT03693989|2914143|Other|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.246|||||||Fisher Exact||||
1584892|NCT03693989|2914144|Other|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.621|||||||Chi-squared, Corrected||||
1584893|NCT03693989|2914145|Other|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.||||||0.223|||||||t-test, 2 sided||||
1584894|NCT03693989|2914146|Other|||||||0.065|||||||t-test, 2 sided|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.|||
1584895|NCT03685643|2914335|Superiority|||||||0.19|||||||Wilcoxon (Mann-Whitney)||||
1584896|NCT03685643|2914336|Superiority|||||||0.12|||||||Wilcoxon (Mann-Whitney)||||
1584897|NCT03685643|2914337|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1584898|NCT03684265|2914342|Equivalence|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|97.04|Standard Error of the Mean|9.96|||2-Sided|90.0|92.57|101.72|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for AUC0-∞. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random|
1584899|NCT03684265|2914343|Equivalence|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|78.94|Standard Error of the Mean|14.57|||2-Sided|90.0|73.7|84.56|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for Cmax. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random|
1584900|NCT03684265|2914344|Equivalence|Bioequivalence acceptance range for the ratio of geometric means was 80- 125%|Geometric mean ratio T/R, %|92.74|Standard Error of the Mean|8.66|||2-Sided|95.0|89.02|96.62|||||Standard error of the mean is actually intra individual coefficient of variation.|Relative bioavailability comparison of Movalis® capsules (T) with Movalis® tablets (R) for AUC0-t. The analysis of variance (ANOVA) model in the log scale was used. This model included the sequence, period and type of therapy as fixed effects and the effect study subjects grouped within the sequence was considered random|
1584901|NCT03679741|2914360|Non-Inferiority|A cumulative odds ratio non-inferiority margin of 0.67 was used. This margin is based on no more than a 10% difference in proportion between the Test and the Control lenses. The odds ratio represents the cumulative odds ratio of having a higher rating/experience of the Test lens compared to the Control lens.|Odds Ratio (OR)|1.73|Standard Deviation|0.459|||2-Sided|95.0|1.0|2.82|||||Odds ratio was calculated as test over control||
1584902|NCT03679741|2914361|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|2.5|Standard Deviation|1.56|||2-Sided|95.0|-0.6|5.5|||||Mean difference was calculated as test minus control|Sample size was based on primary endpoints only.|
1584903|NCT03679741|2914362|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|5.6|Standard Deviation|1.29|||2-Sided|95.0|3.1|8.1|||||Mean difference was calculated as test minus control|Sample size was based on primary endpoints only.|
1584904|NCT03679741|2914363|Non-Inferiority|A non-inferiority cumulative odds ratio margin of 2 was used. This margin corresponds to no more than a 5% difference between the Test and Control lenses assuming the Control reference rate does not exceed 5%. Non-inferiority was declared if the upper bound of the 95% credible interval was below 2.|Mean Difference (Final Values)|0.001|Standard Deviation|0.003|||2-Sided|95.0|-0.004|0.008|||||Mean difference was calculated as Test minus Control.|It was calculated that 50 participants randomized in a 1:1 fashion between the two lens wear sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods.|
1584905|NCT03679741|2914364|Superiority|A superiority margin of 90% was used. Superiority was concluded if the lower limit of the 95% credible interval was above 90%|Mean Percentage of eyes|100.0|Standard Deviation|0.002|||2-Sided|95.0|99.0|100.0||||||It was calculated that 65 participants were required to show that the acceptable lens fitting for the Test lens would be superior to 90% with at least 80% power. Sample size was determined using simulations methods for repeated measures.|
1584906|NCT03679741|2914365|Non-Inferiority|A non-inferiority margin of 0.05 logMAR was used. This margin corresponds to a half line difference. Non-inferiority was declared if the upper bound of the 95% credible interval was below 0.05 logMAR.|Mean Difference (Final Values)|-0.034|Standard Deviation|0.0075|||2-Sided|95.0|-0.049|-0.02|||||Mean difference was calculated as Test minus Control|It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup’s method. The analysis presented below, summarizes the high illumination low contrast lighting condition.|
1591287|NCT03135015|2926024|Other|||||||0.0568|||||||t-test, 2 sided||||
1584907|NCT03679741|2914365|Non-Inferiority|A non-inferiority margin of 0.05 logMAR was used. This margin corresponds to a half line difference. Non-inferiority was declared if the upper bound of the 95% credible interval was below 0.05 logMAR.|Mean Difference (Final Values)|-0.022|Standard Deviation|0.0074|||2-Sided|95.0|-0.037|-0.008|||||Mean difference was calculated as Test minus Control|It was calculated that 4 participants randomized in a 1:1 fashion between the two lens types would have at least 80% power to detect non-inferiority with respect to visual acuity (logMAR) at the 2-week follow-up. Sample size was determined using Stroup’s method. The analysis presented below, summarizes the low luminance high contrast lighting condition.|
1584908|NCT03679741|2914366|Non-Inferiority|A cumulative odds ratio non-inferiority margin of 0.67 was used. This margin is based on no more than a 10% difference in proportion between the Test and the Control lenses. The odds ratio represents the cumulative odds ratio of having a higher rating/experience of the Test lens compared to the Control lens.|Odds Ratio (OR)|3.97|Standard Deviation|1.138|||2-Sided|95.0|2.27|6.62|||||Odds ratio was calculated as test over control||
1584909|NCT03679741|2914367|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|1.9|Standard Deviation|1.99|||2-Sided|95.0|-1.9|5.8|||||Mean difference was calculated as test minus control|It was calculated that 30 participants randomized in a 1:1 fashion between the two lens wear sequences would have at least 80% power to detect a 5 point difference between the test and control lenses with respect to overall comfort at the 2-week follow-up. Sample size was determined using Stroup’s Method (alpha=0.05).|
1584910|NCT03677245|2914383|Other|Wilcoxon signed ranks test used to compared pre-intervention to post-intervention means of the Pediatric Balance Scale. No power calculation performed or utilized.|Mean Difference (Final Values)|1.0|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1584911|NCT03676803|2914392|Other||Mean Difference (Final Values)|55.7||||0.53|2-Sided||||||t-test, 2 sided|||Comparison was made to 2 weeks minus baseline in placebo group|
1584912|NCT03676803|2914392|Other||Mean Difference (Final Values)|86.0||||0.49|2-Sided||||||t-test, 2 sided|||Comparison was made to 2 weeks minus baseline in mixed spices intervention group|
1584913|NCT03676803|2914393|Other||Mean Difference (Final Values)|8.7||||0.097|2-Sided|||||p<0.05 was defined as significant.|ANOVA|||Comparison was made to 2 weeks minus baseline changes in phylum Bacteroidetes abundance between groups.|
1584914|NCT03676803|2914393|Other||Mean Difference (Final Values)|10.6||||0.033|2-Sided|||||p<0.05 was defined as significant|ANOVA|||Comparison was made to 2 weeks minus baseline changes in phylum Firmicutes abundance between groups.|
1584915|NCT03673670|2914415|Other||Median Difference (Final Values)|0.0||||0.501|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1584916|NCT03673670|2914415|Other||Median Difference (Final Values)|0.0||||0.945|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1584917|NCT03673670|2914416|Other|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.002||||0.862|2-Sided|95.0|0.979|1.025|||ANCOVA||||
1584918|NCT03673670|2914416|Other|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.02||||0.096|2-Sided|95.0|0.997|1.043|||ANCOVA||||
1584919|NCT03673670|2914417|Other|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.061||||0.002|2-Sided|95.0|1.023|1.101|||ANCOVA||||
1584920|NCT03673670|2914417|Other|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.082||||0.001|2-Sided|95.0|1.043|1.123|||ANCOVA||||
1584921|NCT03673670|2914418|Other|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.012||||0.404|2-Sided|95.0|0.984|1.039|||ANCOVA||||
1584922|NCT03673670|2914419|Other|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.012||||0.395|2-Sided|95.0|0.984|1.042|||ANCOVA||||
1584923|NCT03673670|2914419|Other|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.027||||0.067|2-Sided|95.0|0.998|1.057|||ANCOVA||||
1584924|NCT03673670|2914420|Other|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.014||||0.303|2-Sided|95.0|0.987|1.043|||ANCOVA||||
1584925|NCT03673670|2914421|Other|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.024||||0.111|2-Sided|95.0|0.994|1.055|||ANCOVA||||
1584926|NCT03673670|2914421|Other|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.024||||0.115|2-Sided|95.0|0.994|1.055|||ANCOVA||||
1584927|NCT03673670|2914422|Other|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|0.995||||0.731|2-Sided|95.0|0.966|1.025|||ANCOVA||||
1584928|NCT03673670|2914422|Other|A hierarchical fixed-sequence testing strategy was employed to test the significance of the treatment effect for each of the two RPL554 doses against placebo, starting with the highest dose (6 mg). If a statistically significant difference was found at the 2-sided α level of 5%, the testing proceeded with the next highest dose. Otherwise, testing was stopped, and the remaining null hypotheses were accepted without testing.|GeoMean Ratio|1.021||||0.168|2-Sided|95.0|0.991|1.052|||ANCOVA||||
1584929|NCT03669081|2914425|Other|The null hypothesis was no difference between groups.|||||>|0.99|||||||Fisher Exact||||
1584930|NCT03669081|2914426|Other|The null hypothesis was no difference between groups.||||||0.002|||||||t-test, 2 sided||||
1584931|NCT03669081|2914427|Non-Inferiority|We conducted a 1-sided non-inferiority test using an alpha level of 0.025, for a comparison of the fold change of creatinine levels (pre-operative creatinine/post-operative creatinine) in the Toradol group. Our minimum non-inferiority margin was 0.5, ie the post-operative creatinine level could only increase to at most two times the pre-operative creatinine level.|||||<|0.0001||||||This p-value was compared to a significance threshold of 0.025.|Wilcoxon (Mann-Whitney)|||The safety outcome was used to power our study.To achieve 90% power at a 2.5% significance level for testing that the post-surgery creatinine increase is at most two-fold (where 1.5 fold is expected), or alternatively for the pre-surgery creatinine group to be ≥0.5 times the post-surgery, we need 17 subjects in the toradol group. This calculation was based on a non-inferiority test (one sided t-test) using a coefficient of variation of 0.25 based on preliminary data.|
1584932|NCT03669081|2914428|Other|The null hypothesis was no difference between groups.||||||0.029|||||||Exact Wilcoxon rank sum test||||
1584933|NCT03669081|2914429|Other|The null hypothesis for the test was no difference between groups.||||||0.006||||||The significance level for this test was 0.05.|Wilcoxon (Mann-Whitney)|We used an exact Wilcoxon rank sum test due to the skewed nature of the morphine equivalents data and the small sample sizes in each group.|||
1584934|NCT03662139|2914472|Superiority||Spearman's correlation coefficient (rs)|-0.673|||<|0.05|2-Sided||||||Spearman's Correlation Test||The level of relationship was classified as follows <0.30=small/negligible; 0.30–0.50=low; 0.50–0.70=moderate; 0.70-0.90=high; >0.90=very high.|Correlation between Dynamic Gait Index (DGI) and Four Square Step Test (FSST) scores in Cerebral Palsy group.|
1584935|NCT03662139|2914472|Superiority||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference|
1584936|NCT03662139|2914473|Superiority||Spearman's correlation coefficient (rs)|-0.828|||<|0.01|2-Sided||||||Spearman's Correlation Test||The level of relationship was classified as follows <0.30=small/negligible; 0.30–0.50=low; 0.50–0.70=moderate; 0.70-0.90=high; >0.90=very high.|Correlation between Dynamic Gait Index (DGI) and Timed Up and Go Test (TUG) scores in Cerebral Palsy group|
1584937|NCT03662139|2914473|Superiority||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference|
1584938|NCT03662139|2914474|Superiority||Spearman's correlation coefficient (rs)|0.724|||<|0.05|2-Sided||||||Spearman's Correlation Test|The level of relationship was classified as follows <0.30=small/negligible; 0.30–0.50=low; 0.50–0.70=moderate; 0.70-0.90=high; >0.90=very high.||Correlation between Dynamic Gait Index (DGI) and Pediatric Balance Scale (PBS) scores in Cerebral Palsy group|
1584939|NCT03662139|2914474|Superiority||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference|
1584940|NCT03662139|2914475|Superiority||ICC|0.983|||<|0.01|2-Sided|95.0|0.882|0.998|||Intraclass Correlation Coefficient(ICC)|Two-way random-effect model|Reliability estimates were interpreted as follows: >0.90=excellent; 0.75-0.90=good; 0.50-0.75=medium; <0.50=low|Interrater Reliability (Difference between 1st and 2nd evaluators in Cerebral Palsy group)|
1584941|NCT03662139|2914475|Superiority||ICC|0.97|||<|0.05|2-Sided|95.0|0.915|0.99|||Intraclass Correlation Coefficient(ICC)|Two-way random-effect model|Reliability estimates were interpreted as follows: >0.90=excellent; 0.75-0.90=good; 0.50-0.75=medium; <0.50=low|Test - Retest Reliability (Difference between 1st and 2nd assessments in Cerebral Palsy group)|
1584942|NCT03662139|2914475|Superiority||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Between group difference|
1584943|NCT03657407|2914517|Superiority||Mean Difference (Final Values)|0.85||||0.42|2-Sided|95.0|0.42|1.7|||t-test, 1 sided|||Null hypothesis that Belladonna & Opium not superior to Placebo|
1584944|NCT03657407|2914518|Superiority||Median Difference (Final Values)|-19.31||||0.05|2-Sided|95.0|-43.1|4.5|||t-test, 1 sided|||Null hypothesis that Belladonna & Opium not superior to Placebo|
1584945|NCT03657407|2914519|Superiority||Mean Difference (Final Values)|-2.02||||0.29|2-Sided|95.0|-5.4|9.5|||t-test, 1 sided|||Null hypothesis that Belladonna & Opium not superior to Placebo|
1584946|NCT03657407|2914520|Superiority||Mean Difference (Final Values)|-0.65||||0.17|2-Sided|95.0|-0.71|2.0|||t-test, 1 sided|||Null hypothesis that Belladonna & Opium not superior to Placebo|
1584947|NCT03657264|2914522|Superiority|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.65|Standard Error of the Mean|1.1|||2-Sided|90.0|8.05|13.25||||||For the timepoint 4 hours|
1591288|NCT03135015|2926024|Other||||||<|0.05|||||||t-test, 2 sided||||
1584948|NCT03657264|2914522|Superiority|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.33|Standard Error of the Mean|1.22|||2-Sided|90.0|7.7|12.95||||||For the timepoint 3 hours|
1584949|NCT03657264|2914522|Superiority|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|10.55|Standard Error of the Mean|1.16|||2-Sided|90.0|7.92|13.17||||||For the timepoint 2 hours|
1584950|NCT03657264|2914522|Superiority|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|9.4|Standard Error of the Mean|1.14|||2-Sided|90.0|7.14|11.66||||||For the timepoint 1.5 hours|
1584951|NCT03657264|2914522|Superiority|The lower limit of the adjusted confidence interval was expected upper to the margin of 5 milliseconds.|Least Squares Mean Difference|4.62|Standard Error of the Mean|1.23|||2-Sided|90.0|2.58|6.66||||||For the timepoint 1 hour|
1584952|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.21|Standard Error of the Mean|1.11|||2-Sided|90.0|-1.62|2.04||||||For the timepoint 24 hours|
1584953|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.94|Standard Error of the Mean|1.36|||2-Sided|90.0|-4.19|0.32||||||For the timepoint 8 hours|
1584954|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-0.85|Standard Error of the Mean|1.11|||2-Sided|90.0|-2.69|1.0||||||For the timepoint 4 hours|
1584955|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.33|Standard Error of the Mean|1.23|||2-Sided|90.0|-3.36|0.71||||||For the timepoint 3 hours|
1584956|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.17|Standard Error of the Mean|1.18|||2-Sided|90.0|-3.13|0.78||||||For the timepoint 2 hours|
1584957|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-1.11|Standard Error of the Mean|1.16|||2-Sided|90.0|-3.03|0.81||||||For the timepoint 1.5 hours|
1584958|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.47|Standard Error of the Mean|1.25|||2-Sided|90.0|-1.6|2.53||||||For the timepoint 1 hour|
1584959|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.43|Standard Error of the Mean|1.04|||2-Sided|90.0|-1.29|2.15||||||For the timepoint 30 min|
1584960|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.2|Standard Error of the Mean|1.16|||2-Sided|90.0|-1.71|2.12||||||For the timepoint 20 min|
1584961|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|1.93|Standard Error of the Mean|1.09|||2-Sided|90.0|0.12|3.73||||||For the timepoint 10 min|
1584962|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|4.81|Standard Error of the Mean|1.19|||2-Sided|90.0|2.84|6.78||||||For the timepoint 5 min|
1584963|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.31|Standard Error of the Mean|1.1|||2-Sided|90.0|-1.52|2.14||||||For the timepoint 24 hours|
1584964|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|1.11|Standard Error of the Mean|1.36|||2-Sided|90.0|-1.15|3.37||||||For the timepoint 8 hours|
1584965|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.27|Standard Error of the Mean|1.11|||2-Sided|90.0|-1.57|2.12||||||For the timepoint 4 hours|
1584966|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|2.39|Standard Error of the Mean|1.23|||2-Sided|90.0|0.35|4.43||||||For the timepoint 3 hours|
1584967|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|-0.03|Standard Error of the Mean|1.18|||2-Sided|90.0|-1.99|1.92||||||For the timepoint 2 hours|
1584968|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.45|Standard Error of the Mean|1.16|||2-Sided|90.0|-1.47|2.37||||||For the timepoint 1.5 hours|
1584969|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.18|Standard Error of the Mean|1.25|||2-Sided|90.0|-1.88|2.25||||||For the timepoint 1 hour|
1584970|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.63|Standard Error of the Mean|1.04|||2-Sided|90.0|-1.09|2.35||||||For the timepoint 30 min|
1584971|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.16|Standard Error of the Mean|1.16|||2-Sided|90.0|-1.76|2.08||||||For the timepoint 20 min|
1584972|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.48|Standard Error of the Mean|1.09|||2-Sided|90.0|-1.32|2.29||||||For the timepoint 10 min|
1585100|NCT03614975|2914998|Other|||||||0.1||||||Vaccine Strain: A/H3N2: Day 0|Kruskal-Wallis||||
1585101|NCT03614975|2914998|Other|||||||0.23||||||Vaccine Strain: A/H1N1: Day 21|Kruskal-Wallis||||
1584973|NCT03657264|2914523|Non-Inferiority|The upper limit of the 90% confidence interval was expected lower to the margin of 10 milliseconds for all tests.|Least Squares Mean Difference|0.73|Standard Error of the Mean|1.18|||2-Sided|90.0|-1.23|2.69||||||For the timepoint 5 min|
1584974|NCT03655301|2914528|Other||Least squares mean|1.1147|||||2-Sided|90.0|0.9772|1.2714||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of AUC|
1584975|NCT03655301|2914529|Other||Least squares mean|1.1205|||||2-Sided|90.0|1.0|1.2555||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of AUC(0-24)|
1584976|NCT03655301|2914530|Other||Least squares mean|0.9405|||||2-Sided|90.0|0.8093|1.0931||||||Day 8 (with copanlisib) to Day 1 (without copanlisib) ratio of Cmax|
1584977|NCT03651479|2914554|Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)||||
1584978|NCT03647709|2914627|Other|||||||1|||||||Fisher Exact||||
1584979|NCT03647709|2914628|Other|||||||0.0658|||||||Fisher Exact||||
1584980|NCT03647709|2914629|Other|||||||0.6398|||||||Fisher Exact||||
1584981|NCT03647709|2914630|Other|||||||0.0015|||||||Fisher Exact||||
1584982|NCT03647709|2914633|Other||mean score|0.5|||||2-Sided|95.0|0.4|0.7|||||Represents patients reported pain score post operative week 12 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584983|NCT03647709|2914633|Other||mean score|0.0|||||2-Sided|95.0|0.0|0.1|||||Represents patients reported pain score post operative week 12 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584984|NCT03647709|2914633|Other||mean score|0.2|||||2-Sided|95.0|0.1|0.2|||||Represents patients reported pain score post operative week 12 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584985|NCT03647709|2914633|Other||mean score|0.0|||||2-Sided|95.0|0.0|0.0|||||Represents patients reported pain score post operative week 12 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584986|NCT03647709|2914633|Other||mean score|1.9|||||2-Sided|95.0|1.7|2.0|||||Represents patients reported pain score post operative week 6 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584987|NCT03647709|2914633|Other||mean score|0.5|||||2-Sided|95.0|0.4|0.6|||||Represents patients reported pain score post operative week 6 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584988|NCT03647709|2914633|Other||mean score|0.7|||||2-Sided|95.0|0.5|0.8|||||Represents patients reported pain score post operative week 6 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584989|NCT03647709|2914633|Other||mean score|0.1|||||2-Sided|95.0|0.0|0.2|||||Represents patients reported pain score post operative week 6 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584990|NCT03647709|2914633|Other||mean score|3.1|||||2-Sided|95.0|2.9|3.3|||||Represents patients reported pain score post operative week 3 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584991|NCT03647709|2914633|Other||mean score|1.3|||||2-Sided|95.0|1.2|1.5|||||Represents patients reported pain score post operative week 3 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584992|NCT03647709|2914633|Other||mean score|1.5|||||2-Sided|95.0|1.3|1.7|||||Represents patients reported pain score post operative week 3 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584993|NCT03647709|2914633|Other||mean score|0.3|||||2-Sided|95.0|0.2|0.4|||||Represents patients reported pain score post operative week 3 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584994|NCT03647709|2914633|Other||mean score|4.0|||||2-Sided|95.0|3.8|4.2|||||Represents patients reported pain score post operative days 10-14 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584995|NCT03647709|2914633|Other||mean score|2.0|||||2-Sided|95.0|1.8|2.2|||||Represents patients reported pain score post operative days 10-14 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584996|NCT03647709|2914633|Other||mean score|2.1|||||2-Sided|95.0|1.9|2.3|||||Represents patients reported pain score post operative days 10-14 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584997|NCT03647709|2914633|Other||mean score|0.5|||||2-Sided|95.0|0.4|0.7|||||Represents patients reported pain score post operative days 10-14 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584998|NCT03647709|2914633|Other||mean score|5.0|||||2-Sided|95.0|4.8|5.2|||||Represents patients reported pain score post operative day 3 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1584999|NCT03647709|2914633|Other||mean score|3.3|||||2-Sided|95.0|3.1|3.5|||||Represents patients reported pain score post operative day 3 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1585000|NCT03647709|2914633|Other||mean score|2.4|||||2-Sided|95.0|2.2|2.6|||||Represents patients reported pain score post operative day 3 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1585001|NCT03647709|2914633|Other||mean score|1.0|||||2-Sided|95.0|0.8|1.2|||||Represents patients reported pain score post operative day 3 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1585002|NCT03647709|2914633|Other||mean score|5.9|||||2-Sided|95.0|5.7|6.1|||||Represents patients reported pain score post operative day 2 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1585003|NCT03647709|2914633|Other||mean score|4.2|||||2-Sided|95.0|4.0|4.4|||||Represents patients reported pain score post operative day 2 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1585004|NCT03647709|2914633|Other||mean score|3.4|||||2-Sided|95.0|3.2|3.6|||||Represents patients reported pain score post operative day 2 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1585005|NCT03647709|2914633|Other||mean score|1.8|||||2-Sided|95.0|1.6|2.0|||||Represents patients reported pain score post operative day 2 best at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1585006|NCT03647709|2914633|Other||mean score|4.6|||||2-Sided|95.0|4.4|4.8|||||Represents patients reported pain score post operative day 1 worst with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1585007|NCT03647709|2914633|Other||mean score|2.9|||||2-Sided|95.0|2.7|3.1|||||Represents patients reported pain score post operative day 1 best with activity|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity|
1585008|NCT03647709|2914633|Other||mean score|2.4|||||2-Sided|95.0|2.2|2.6|||||Represents patients reported pain score post operative day 1 worst at rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.|
1585009|NCT03647709|2914633|Other||mean score|1.0|||||2-Sided|95.0|0.9|1.2|||||Represents patients pain score post operative day 1 best with rest|Comparison of change in patient's reported pain with rest or during activity at various time intervals. Patients reported best and worst pain scores at rest and during activity.|
1585010|NCT03645421|2914653|Other||LS mean difference|-0.049|Standard Error of the Mean|0.012||0.0002|2-Sided|95.0|-0.074|-0.024|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg – Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.|
1585011|NCT03645421|2914653|Other||LS mean difference|-0.053|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|-0.077|-0.03|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg – Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.|
1585012|NCT03645421|2914653|Other||LS mean difference|-0.071|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|-0.094|-0.047|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg – Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.|
1585013|NCT03645421|2914654|Other||LS mean difference|-55.07|Standard Error of the Mean|9.55|<|0.0001|2-Sided|95.0|-74.28|-35.86|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg – Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.|
1585014|NCT03645421|2914654|Other||LS mean difference|-60.58|Standard Error of the Mean|9.92|<|0.0001|2-Sided|95.0|-80.53|-40.63|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg – Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.|
1585015|NCT03645421|2914654|Other||LS mean difference|-56.69|Standard Error of the Mean|8.75|<|0.0001|2-Sided|95.0|-74.3|-39.09|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg – Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.|
1585016|NCT03645421|2914655|Other||LS mean difference|-0.76|Standard Error of the Mean|0.19||0.0002|2-Sided|95.0|-1.15|-0.38|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg – Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.|
1585017|NCT03645421|2914655|Other||LS mean difference|-1.1|Standard Error of the Mean|0.19|<|0.0001|2-Sided|95.0|-1.49|-0.71|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg – Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.|
1585018|NCT03645421|2914655|Other||LS mean difference|-1.09|Standard Error of the Mean|0.19|<|0.0001|2-Sided|95.0|-1.48|-0.7|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg – Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.|
1585019|NCT03645421|2914658|Other||LS mean difference|-2.52|Standard Error of the Mean|0.89||0.0063|2-Sided|95.0|-4.3|-0.74|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.|
1585020|NCT03645421|2914658|Other||LS mean difference|-2.53|Standard Error of the Mean|0.92||0.008|2-Sided|95.0|-4.37|-0.69|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.|
1585021|NCT03645421|2914658|Other||LS mean difference|-1.3|Standard Error of the Mean|0.89||0.1476|2-Sided|95.0|-3.08|0.47|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.|
1585102|NCT03614975|2914998|Other|||||||0.49||||||Vaccine Strain: A/H1N1: Day 0|Kruskal-Wallis||||
1591289|NCT03135015|2926025|Other|||||||0.0331|||||||t-test, 2 sided||||
1585022|NCT03645421|2914659|Other||LS mean difference|-40.3|Standard Error of the Mean|4.57|<|0.0001|2-Sided|95.0|-49.49|-31.12|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 300 mcg - Placebo|Pair-wise comparison of MEDI0382 300 mcg versus Placebo.|
1585023|NCT03645421|2914659|Other||LS mean difference|-33.61|Standard Error of the Mean|4.69|<|0.0001|2-Sided|95.0|-43.04|-24.18|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 200 mcg - Placebo|Pair-wise comparison of MEDI0382 200 mcg versus Placebo.|
1585024|NCT03645421|2914659|Other||Least squares (LS) mean difference|-42.11|Standard Error of the Mean|4.16|<|0.0001|2-Sided|95.0|-50.47|-33.75|||ANCOVA|Analysis used treatment group as a factor and baseline as a covariate.|Treatment difference = MEDI0382 100 mcg - Placebo|Pair-wise comparison of MEDI0382 100 mcg versus Placebo.|
1585025|NCT03640052|2914721|Superiority|||||||0.12|||||||Mixed Models Analysis||||
1585026|NCT03640052|2914722|Superiority||Mean Difference (Net)|-11.7||||0.33|2-Sided||||||Mixed Models Analysis|||mean difference vs Placebo|
1585027|NCT03640052|2914722|Superiority||Mean Difference (Net)|-6.8|||>|0.5|2-Sided||||||Mixed Models Analysis|||mean difference vs Placebo|
1585028|NCT03640052|2914722|Superiority||Mean Difference (Net)|-2.0|||>|0.5|2-Sided||||||Mixed Models Analysis|||mean difference vs Placebo|
1585029|NCT03640052|2914722|Superiority||Mean Difference (Final Values)|3.6|||>|0.5|2-Sided||||||Mixed Models Analysis|||mean difference vs Placebo|
1585030|NCT03639675|2914724|Other||Mean change|-8.3||||0.0004|2-Sided|95.0|-12.2|-4.4|||one-sample t-statistics||||
1585031|NCT03637517|2914756|Equivalence|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|LEAST SQUARES MEANS FOR LOGARITHMS.|1.156||||0.1619|2-Sided|90.0|0.974|1.371|||ANOVA||||
1585032|NCT03637517|2914756|Equivalence|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|LEAST SQUARES MEANS FOR LOGARITHMS.|0.901||||0.31|2-Sided|90.0|0.759|1.069|||ANOVA||||
1585033|NCT03637517|2914757|Equivalence|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.185||||0.1105|2-Sided|90.0|0.995|1.411||For tests on regimen effects, the denominator sum of squares is the residual sum of squares for error. Within the ANOVA modeling framework, the test regimen is compared to the respective reference regimen by a test with a significance level of 0.05.|ANOVA||||
1585034|NCT03637517|2914757|Equivalence|Bioequivalence between a test regimen and the respective reference regimen will be concluded if the 90% confidence intervals from the analyses of the natural logarithms of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.866||||0.1745|2-Sided|90.0|0.727|1.032|||ANOVA|||(ANOVA) will be performed for Tmax, the terminal phase elimination rate constant β, and the natural logarithms of Cmax, AUCt, AUC168, AUCinf, and C168. The model will include the effects for regimen. For the tests on regimen effects, the denominator sum of squares will be the residual sum of squares for error. Within the ANOVA modeling framework, the test regimen will be compared to the respective reference regimen by a test with a significance level of 0.05.|
1585035|NCT03637517|2914759|Equivalence|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper & lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Least Squares Means|9.3571|Standard Error of the Mean|1.866979|||2-Sided|90.0|6.2115|12.5028|||||Regimen C to B||
1585036|NCT03637517|2914759|Equivalence|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper & lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Least Squares Means|-0.2857|Standard Error of the Mean|1.866979|||2-Sided|90.0|-3.4313|2.8599|||||||
1585037|NCT03637517|2914760|Equivalence|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper & lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.172||||0.0496|2-Sided|90.0|1.027|1.338|||ANOVA||Regimen C to B||
1585038|NCT03637517|2914760|Equivalence|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper & lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.898||||0.1759|2-Sided|90.0|0.787|1.024|||ANOVA||Regimen B to A||
1585039|NCT03637517|2914761|Equivalence|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper & lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|1.175||||0.0192|2-Sided|90.0|1.051|1.312|||ANOVA||||
1585103|NCT03614975|2914999|Other|||||||0.21||||||Vaccine Strain: B/Phuket: Day 21|Chi-squared||||
1585104|NCT03614975|2914999|Other|||||||0.33||||||Vaccine Strain: B/Phuket: Day 0|Chi-squared||||
1585105|NCT03614975|2914999|Other|||||||0.77||||||Vaccine Strain: B/Colorado : Day 21|Chi-squared||||
1585106|NCT03614975|2914999|Other|||||||0.87||||||Vaccine Strain: B/Colorado :Day 0|Chi-squared||||
1585040|NCT03637517|2914761|Equivalence|Bioavailability of each test reg. relative to each reference reg will be assessed via 90% CI obtained from the analyses of the natural logs of Cmax and AUC. These CI are obtained by taking the antilog of the upper & lower CI for the difference of the least squares means on the log scale within the ANOVA model. Bioequivalence between a test reg and the respective reference reg will be concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within the 0.80 to 1.25 range.|Sum of squares|0.899||||0.1135|2-Sided|90.0|0.805|1.004|||ANOVA||||
1585041|NCT03637517|2914762|Equivalence|2 comparisons performed: Reg. B vs. Reg. A, & Reg.C vs. Reg. B. Bioavailability of each test reg. relative to that of each reference reg. assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model. Bioequivalence between a test reg. and the reference reg. is concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within 0.80 to 1.25 range.|Least Squares Means Log scale|0.79||||0.037|2-Sided|90.0|0.658|0.95|||ANOVA||||
1585042|NCT03637517|2914762|Equivalence|2 comparisons performed: Reg. B vs. Reg. A, & Reg.C vs. Reg. B. Bioavailability of each test reg. relative to that of each reference reg. assessed via 90% CI. CI obtained by taking the antilog of the upper and lower limits of CI for the difference of the least squares means on the log scale within the ANOVA framework model. Bioequivalence between a test reg. and the reference reg. is concluded if the 90% CI from the analyses of the natural log of Cmax and AUC are within 0.80 to 1.25 range.|Least Squares Means Log scale|0.926||||0.4847|2-Sided|90.0|0.771|1.113|||ANOVA||||
1585043|NCT03633825|2914796|Superiority||Risk Ratio (RR)|1.2|||=|0|2-Sided|95.0|0.91|1.59|||Chi-squared||||
1585044|NCT03633825|2914797|Superiority||Risk Ratio (RR)|1.23|||=|0|2-Sided|95.0|1.03|1.46|||Chi-squared||||
1585045|NCT03629054|2914876|Equivalence|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|95.74|Standard Error of the Mean|7.8|<|0.0001|2-Sided|90.0|92.29|99.32|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for ‘sequence’, ‘period’ and ‘treatment’ and random effect for 'subject within sequence'.|
1585046|NCT03629054|2914877|Equivalence|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|103.57|Standard Error of the Mean|14.3|<|0.0001|2-Sided|90.0|96.9|110.71|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for ‘sequence’, ‘period’ and ‘treatment’ and random effect for 'subject within sequence'.|
1585047|NCT03629054|2914878|Equivalence|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|100.73|Standard Error of the Mean|5.1|<|0.0001|2-Sided|90.0|98.33|103.18|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for ‘sequence’, ‘period’ and ‘treatment’ and random effect for 'subject within sequence'.|
1585048|NCT03629054|2914879|Equivalence|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|104.83|Standard Error of the Mean|13.2|<|0.0001|2-Sided|90.0|98.56|111.5|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for ‘sequence’, ‘period’ and ‘treatment’ and random effect for 'subject within sequence'.|
1585049|NCT03629054|2914880|Equivalence|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|97.33|Standard Error of the Mean|16.9||0.0001|2-Sided|90.0|89.99|105.26|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for ‘sequence’, ‘period’ and ‘treatment’ and random effect for 'subject within sequence'.|
1585050|NCT03629054|2914881|Equivalence|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|92.57|Standard Error of the Mean|17.9||0.0029|2-Sided|90.0|85.21|100.57|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for ‘sequence’, ‘period’ and ‘treatment’ and random effect for 'subject within sequence'.|
1585051|NCT03629054|2914882|Equivalence|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|100.16|Standard Error of the Mean|8.6|<|0.0001|2-Sided|90.0|96.17|104.31|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for ‘sequence’, ‘period’ and ‘treatment’ and random effect for 'subject within sequence'.|
1585052|NCT03629054|2914883|Equivalence|The assessment of bioequivalence was based upon two-sided 90% CIs for the ratios of the geometric means (T/R).|Adjusted gMean ratio|95.34|Standard Error of the Mean|8.5|<|0.0001|2-Sided|90.0|91.58|99.24|||ANOVA||gMean ratio = T/R. Standard Error of the mean is actually intra-individual gCV.|An ANOVA model on the logarithmic scale including fixed effects for ‘sequence’, ‘period’ and ‘treatment’ and random effect for 'subject within sequence'.|
1585053|NCT03629054|2914884|Equivalence|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (gMean) (T/R).|Adjusted gMean ratio|100.42|Standard Error of the Mean|4.8|<|0.0001|2-Sided|90.0|98.17|102.72|||ANOVA||gMean ratio = T/R. Standard error of the mean is actually intra-individual geometric coefficient of variation (gCV).|An ANOVA model on the logarithmic scale including fixed effects for ‘sequence’, ‘period’ and ‘treatment’ and random effect for 'subject within sequence'.|
1585054|NCT03629028|2914895|Non-Inferiority|Data compared to meta-analysis conducted in Sardo et al., 2017||||||0.05|||||||Chi-squared|Chi-squared or Fisher’s test statistic was used to compare the categorical variables.||The sample size was calculated based on the study of Sardo et al. The website http://powerandsamplesize.com/Calculators was used. As a result of the sample size calculation with 90% power and 0.05 alpha error, it was planned to include 141 patients in each group.|
1585055|NCT03628885|2914896|Superiority||||||<|0.01||||||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P<.05|ANOVA|||Adjusted for mother's educational level, which differed across groups. A priori threshold for statistical significance = P<.05|
1585107|NCT03614975|2914999|Other|||||||0.94||||||Vaccine Strain: A/H3N2: Day 21|Chi-squared||||
1585058|NCT03628417|2914905|Non-Inferiority|Examined the objective response rate (ORR) that there was 20% difference between the 2 treatment arms at day 180. With a significance level of 0,05 and a power of 80% the study required 28 evaluable metastases.|Odds Ratio (OR)|0.4489629||||0.3|2-Sided|95.0|-13.3|53.3|||Fisher Exact|||After reviewing existing data from electrochemotherapy with intratumoral bleomycin on small cutaneous metastases ≤3cm , we estimated the expected response rate for electrochemotherapy to 85%. We have no clinical results for the treatment of calcium electroporation, but on the basis of preclinical studies, we decided to accept a difference in response of 20%. All statistical analysis were done using IBM SPSS v24.|
1585059|NCT03626415|2914919|Other|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|114.82|||||2-Sided|90.0|87.19|151.2||||||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)|
1585060|NCT03626415|2914919|Other|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|95.74|||||2-Sided|90.0|72.71|126.08||||||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)|
1585061|NCT03626415|2914920|Other|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|84.14|||||2-Sided|90.0|63.59|111.33||||||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)|
1585062|NCT03626415|2914920|Other|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|75.94|||||2-Sided|90.0|57.39|100.47||||||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)|
1585063|NCT03626415|2914921|Other|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Mean|153.99|||||2-Sided|90.0|99.52|238.25||||||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)|
1585064|NCT03626415|2914921|Other|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Means|133.33|||||2-Sided|90.0|86.17|206.28||||||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)|
1585065|NCT03626415|2914922|Other|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adusted Geometric Means|105.53|||||2-Sided|90.0|70.38|158.24||||||Moderate Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)|
1585066|NCT03626415|2914922|Other|The ratio and 90% confidence interval were expressed as percentages.|Ratio of Adjusted Geometric Mean|94.4|||||2-Sided|90.0|62.96|141.55||||||Mild Hepatic Impairment (Test) versus Normal Hepatic Function (Reference)|
1585067|NCT03620708|2914931|Superiority||Mean Difference (Final Values)|1.728||||0.188|2-Sided||||||ANOVA||||
1585068|NCT03620708|2914932|Superiority||Mean Difference (Final Values)|1.712||||0.19|2-Sided||||||ANOVA|||Examination of differences between groups at follow-up on a measure of self-reported readiness to quit smoking.|
1585069|NCT03620708|2914932|Superiority||Mean Difference (Final Values)|0.338||||0.715|2-Sided||||||ANOVA|||Examination of differences between groups at follow-up on a measure of self-reported importance of quitting smoking.|
1585070|NCT03620708|2914932|Superiority||Mean Difference (Final Values)|1.543||||0.227|2-Sided||||||ANOVA|||Examination of differences between groups at follow-up on a measure of confidence in ability to quit.|
1585071|NCT03620708|2914933|Superiority||Mean Difference (Final Values)|3.661||||0.032|2-Sided||||||ANOVA||||
1585072|NCT03620708|2914934|Superiority||chi-square|4.36||||0.113|2-Sided||||||Chi-squared||||
1585073|NCT03620708|2914935|Superiority||chi-square|3.492|||<|0.05|2-Sided||||||Chi-squared||||
1585074|NCT03619889|2914942|Other||Mean Difference (Net)|-0.65|||<|0.001|2-Sided||||||t-test, 2 sided||||
1585075|NCT03619889|2914942|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1585076|NCT03619889|2914949|Other||Mean Difference (Net)|-1.2|||<|0.001|2-Sided||||||t-test, 2 sided||||
1585077|NCT03619889|2914949|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1585078|NCT03616977|2914976|Equivalence|Bioequivalence will be concluded if the 2-sided 90% Confidence Interval is completely contained within the interval (0.80, 1.25).|Ratio of geometric least squares means|1.01|||||2-Sided|90.0|0.961|1.06|||||||
1585079|NCT03615534|2914990|Superiority|||||||0.966||||||Results were evaluated in terms of adjusted end line systolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: systolic blood pressure= 121.5 mmHg.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline systolic blood pressure level as a covariate.|
1585080|NCT03615534|2914990|Other|||||||0.434||||||Results were evaluated in terms of adjusted end line diastolic blood pressure levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: diastolic blood pressure= 80.0 mmHg.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline diastolic blood pressure level as a covariate.|
1585081|NCT03615534|2914991|Superiority|||||||0.511||||||Results were evaluated in terms of adjusted end line CK levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: CK= 28.0 IU/L.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline CK level as a covariate.|
1585082|NCT03615534|2914991|Superiority|||||||0.033||||||Results were evaluated in terms of adjusted end line ALT levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: ALT= 16.0 IU/L.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ALT level as a covariate.|
1585083|NCT03615534|2914991|Other|||||||0.201||||||Results were evaluated in terms of adjusted end line AST levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|"Covariates appearing in ANCOVA model are evaluated at the following baseline values: AST= 18.1 IU/L.~."||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline AST level as a covariate.|
1585084|NCT03615534|2914992|Superiority|||||||0.0001||||||Results were evaluated in terms of adjusted end line serum uric acid levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: serum uric acid= 5.0 mg/dl.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline serum uric acid level as a covariate.|
1585085|NCT03615534|2914993|Superiority|||||||0.786||||||Results were evaluated in terms of adjusted end line eGFR levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: eGFR= 88.0 ml/min per 1.73 m^2.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline eGFR level as a covariate.|
1585086|NCT03615534|2914994|Superiority|||||||0.001||||||Results were evaluated in terms of adjusted end line FSG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|ANCOVA|Covariates appearing in ANCOVA model are evaluated at the following baseline values: FSG= 95.7 mg/dl.||Analysis of Covariance (ANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline FSG level as a covariate.|
1585087|NCT03615534|2914995|Superiority|||||||0.067||||||Results were evaluated in terms of adjusted end line ApoB levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values:ApoB=133.1, RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1mg/dl||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoB level as a covariate, with further adjustments for baselineTC, Non HDL-C, dLDL-C, and RC .|
1585088|NCT03615534|2914995|Superiority|||||||0.058||||||Results were evaluated in terms of adjusted end line ApoA1 levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: ApoA1 = 144.6 mg/dl, TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline ApoA1 level as a covariate, with further adjustments for baseline TG and HDL-C levels.|
1585089|NCT03615534|2914996|Superiority|||||||0.001||||||Results were evaluated in terms of adjusted end line RC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values:RC=48.9,TC=199.9, Non HDL-C=168.0, d-LDL-C=119.1, ApoB=133.1mg/dl||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline RC level as a covariate, with further adjustments for baselineTC, Non HDL-C, d-LDL-C, and ApoB.|
1585090|NCT03615534|2914996|Superiority|||||||0.012||||||Results were evaluated in terms of adjusted end line Non HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: Non HDL-C= 168.0 mg/dl,TC=199.9 mg/dl, d-LDL-C= 119.1 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline Non HDL-C level as a covariate, with further adjustments for baseline TC and d-LDL-C.|
1585091|NCT03615534|2914996|Superiority|||||||0.334||||||Results were evaluated in terms of adjusted end line d-LDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: d-LDL-C= 119.1 mg/dl.TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl,||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline d-LDL-C level as a covariate, with further adjustments for baseline TC and Non HDL-C .|
1585092|NCT03615534|2914996|Superiority|||||||0.0001||||||Results were evaluated in terms of adjusted end line HDL-C levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: HDL-C = 31.8 mg/dL,TG= 240.4 mg/dL, ApoA1 = 144.6 mg/dL.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline HDL-C level as a covariate, with further adjustments for baselineTG, ApoA1levels.|
1585093|NCT03615534|2914996|Superiority|||||||0.06||||||Results were evaluated in terms of adjusted end line TC levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: TC=199.9 mg/dl, Non HDL-C= 168.0 mg/dl, d-LDL-C= 119.1 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TC level as a covariate, with further adjustments for baseline Non HDL-C and d-LDL-C.|
1585094|NCT03615534|2914997|Superiority|||||||0.0001||||||Results were evaluated in terms of adjusted end line TG levels, embracing the least significant difference (LSD) for pair-wise comparison. Probability of less than 0.05 was considered statistically significant.|MANCOVA|Covariates appearing in MANCOVA model are evaluated at the following baseline values: TG= 240.4 mg/dl, HDL-C = 31.8 mg/dl, ApoA1 = 144.6 mg/dl.||Multivariate Analysis of Covariance (MANCOVA), was applied to assess treatment effects among different arms, comprising the influence of the baseline TG level as a covariate, with further adjustments for baseline HDL-C, ApoA1levels.|
1585095|NCT03614975|2914998|Other|||||||0.65||||||Vaccine Strain: B/Phuket: Day 21|Kruskal-Wallis||||
1585096|NCT03614975|2914998|Other|||||||0.36||||||Vaccine Strain: B/Phuket: Day 0|Kruskal-Wallis||||
1585097|NCT03614975|2914998|Other|||||||0.67||||||Vaccine Strain: B/Colorado: Day 21|Kruskal-Wallis||||
1585098|NCT03614975|2914998|Other|||||||0.73||||||Vaccine Strain: B/Colorado: Day 0|Kruskal-Wallis||||
1585099|NCT03614975|2914998|Other|||||||0.86||||||Vaccine Strain: A/H3N2: Day 21|Kruskal-Wallis||||
1585115|NCT03613649|2915036|Non-Inferiority|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.63|||||1-Sided|98.75|8.698|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 4 h after dose.|
1585116|NCT03613649|2915036|Non-Inferiority|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.62|||||1-Sided|98.75|8.683|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 3 h after dose.|
1585117|NCT03613649|2915036|Non-Inferiority|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.79|||||1-Sided|98.75|8.86|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 2 h after dose.|
1585118|NCT03613649|2915036|Non-Inferiority|"According to ICH E14, the positive control should have an effect on the mean QT/QTc interval of about 5 ms. Comparison of the lower bound of the confidence interval to 5 ms for a 400 mg dose of moxifloxacin is standard practice for demonstrating assay sensitivity in thorough QT studies."|Least-Squares Mean Double Delta Value|10.19|||||1-Sided|98.75|8.257|||||||Null Hypothesis: The trial does not have the sensitivity to detect an effect on QTcF of regulatory concern, as produced by 400 mg moxifloxacin 1 h after dose.|
1585119|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.72|||||1-Sided|95.0||3.415||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585120|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.82|||||1-Sided|95.0||3.459||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585121|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.07|||||1-Sided|95.0||1.566||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585122|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.63|||||1-Sided|95.0||3.259||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585123|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|3.04|||||1-Sided|95.0||4.674||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585124|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.59|||||1-Sided|95.0||4.228||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585125|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.18|||||1-Sided|95.0||3.812||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585126|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|2.36|||||1-Sided|95.0||3.997||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585127|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.17|||||1-Sided|95.0||2.815||||||Null Hypothesis: Zoliflodacin administered at a 4 g dose causes a prolongation of the QTcF interval 0.5 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585128|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.53|||||1-Sided|95.0||1.131||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 24 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585129|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.03|||||1-Sided|95.0||1.65||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 12 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585583|NCT03551730|2915835|Superiority||Least Squares Means (Difference)|96385.09||||0.0032|2-Sided||||||ANCOVA||||
1585130|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|-0.83|||||1-Sided|95.0||0.79||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 8 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585131|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.45|||||1-Sided|95.0||2.074||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 6 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585132|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.17|||||1-Sided|95.0||2.792||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 4 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585133|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|1.42|||||1-Sided|95.0||3.044||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 3 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585134|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.17|||||1-Sided|95.0||1.795||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 2 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585135|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern.|Least-Squares Mean Double Delta Value|0.59|||||1-Sided|95.0||2.2||||||Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 1 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).|
1585136|NCT03613649|2915041|Non-Inferiority|Per ICH E14, an increase in the QTcF interval of 5 ms, as evidenced by the upper bound of a 95% one-sided confidence interval above 0.10, is the threshold for regulatory concern. Statistically, the test of prolongation is equivalent to a non-inferiority test versus placebo by crossover design, with an non-inferiority margin of 10 ms.|Least-Squares Mean Double Delta Value|-0.99|||||1-Sided|95.0||0.635||||||"Null Hypothesis: Zoliflodacin administered at a 2 g dose causes a prolongation of the QTcF interval 0.5 h post-dose that exceeds the criteria in the ICH Guidance E14 (5 ms).~Power Calculation:~Enrollment of 72 subjects would provide at least 84% power to conclude a negative effect, given that up to 16 subjects may withdraw early prior to beginning to replace subjects (at least 56 subjects evaluable), and assuming a standard deviation of ΔΔQTcF of 7 msec and an underlying effect of 5 msec."|
1585137|NCT03613129|2915043|Non-Inferiority|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.417|||||||t-test, 2 sided||||
1585138|NCT03613129|2915043|Non-Inferiority|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.355|||||||t-test, 2 sided||||
1585139|NCT03613129|2915043|Non-Inferiority|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.634|||||||t-test, 2 sided||||
1585140|NCT03613129|2915043|Non-Inferiority|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.618|||||||t-test, 2 sided||||
1585141|NCT03613129|2915043|Non-Inferiority|Comparing pre-treatment MCS (at Visit 3) and post-treatment MCS (at Visit 6)||||||0.587|||||||t-test, 2 sided||||
1585142|NCT03613129|2915044|Non-Inferiority|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.06|||||||t-test, 2 sided||||
1585143|NCT03613129|2915044|Non-Inferiority|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.053|||||||t-test, 2 sided||||
1585144|NCT03613129|2915044|Non-Inferiority|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.016|||||||t-test, 2 sided||||
1585145|NCT03613129|2915044|Non-Inferiority|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.191|||||||t-test, 2 sided||||
1585146|NCT03613129|2915044|Non-Inferiority|Comparing pre-treatment PCS (at Visit 3) and post-treatment PCS (at Visit 6)||||||0.039|||||||t-test, 2 sided||||
1585147|NCT03613129|2915045|Non-Inferiority|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.24|||||||t-test, 2 sided||||
1585148|NCT03613129|2915045|Non-Inferiority|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.451|||||||t-test, 2 sided||||
1585149|NCT03613129|2915045|Non-Inferiority|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.009|||||||t-test, 2 sided||||
1585150|NCT03613129|2915045|Non-Inferiority|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.136|||||||t-test, 2 sided||||
1585151|NCT03613129|2915045|Non-Inferiority|Comparing 28-day pre-treatment mean TDSS and 28-day post-treatment mean TDSS||||||0.011|||||||t-test, 2 sided||||
1585152|NCT03601715|2915089|Superiority||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).
1585153|NCT03601715|2915090|Superiority||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).
1585505|NCT03569033|2915480|Other||Difference in Least Squares Means|-0.32||||0.748|2-Sided|95.0|-2.29|1.66|||Longitudinal Data Analysis||||
1591290|NCT03135015|2926025|Other|||||||0.1234|||||||t-test, 2 sided||||
1585154|NCT03601715|2915091|Superiority||||||<|0.05||||||Bonferroni post-hoc tests.|ANOVA|||Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.|Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).
1585155|NCT03591406|2915131|Non-Inferiority|Pre-defined non-inferiority margin of −15%|Difference in proportions|1.12|||||2-Sided|95.0|-2.15|4.71|||||2-sided 95% Confidence Interval (CI) was computed using the Wilson score method with continuity correction described by Newcombe.||
1585156|NCT03587428|2915175|Superiority||Mean Difference (Final Values)|-0.7037||||0.0063|2-Sided|95.0|-1.1886|-0.2187|||ANCOVA|ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.|Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.||
1585157|NCT03587428|2915175|Superiority||Mean Difference (Final Values)|-0.3252||||0.1787|2-Sided|95.0|-0.8101|0.1596|||ANCOVA|ANCOVA for treatment and period as fixed effects and subject as random effect and two baseline terms as covariates.|Difference is first named treatment minus second named treatment; a positive difference favors the first named treatment.||
1585158|NCT03587207|2915183|Other|M07-0241084 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.82|||||2-Sided|80.0|0.65|1.03||||||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.|
1585159|NCT03587207|2915183|Other|NZ98/254 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.69|||||2-Sided|80.0|0.54|0.89||||||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.|
1585160|NCT03587207|2915183|Other|96217 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.58|||||2-Sided|80.0|0.47|0.73||||||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.|
1585161|NCT03587207|2915183|Other|M14459 strain-Between group ratio for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.91|||||2-Sided|80.0|0.71|1.15||||||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp)strain, one month after first vaccination.|
1585162|NCT03587207|2915183|Other|M07-0241084 strain-Between group ratio for comparison of rMenBOMV_ACWY_D group and rMenBOMV group|Geometrical mean ratio|0.88|||||2-Sided|80.0|0.7|1.1||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_D versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.|
1585163|NCT03587207|2915183|Other|NZ98/254 strain -Between group ratio for comparison of rMenBOMV_ACWY_D group and rMenBOMV group|Geometrical mean ratio|0.87|||||2-Sided|80.0|0.68|1.12||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_D versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.|
1585164|NCT03587207|2915183|Other|96217 strain -Between group ratio for comparison of rMenBOMV_ACWY_D group and rMenBOMV group|Geometric mean ratio|0.87|||||2-Sided|80.0|0.69|1.09||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_D versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.|
1585165|NCT03587207|2915183|Other|M14459 strain -Between group ratio for comparison of rMenBOMV_ACWY_D group and rMenBOMV group|Geometric mean ratio|0.81|||||2-Sided|80.0|0.64|1.03||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_D versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.|
1585166|NCT03587207|2915183|Other|M07-0241084 strain -Between group ratio for comparison of rMenBOMV_ACWY_S group and rMenBOMV group|Geometric mean ratio|0.95|||||2-Sided|80.0|0.76|1.19||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_S versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.|
1585167|NCT03587207|2915183|Other|NZ98/254 strain -Between group ratio for comparison of rMenBOMV_ACWY_S group and rMenBOMV group|Geometric mean ratio|0.88|||||2-Sided|80.0|0.69|1.13||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_S versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.|
1585168|NCT03587207|2915183|Other|96217 strain-Between group ratio for comparison of rMenBOMV_ACWY_S group and rMenBOMV group|Geometric mean ratio|0.8|||||2-Sided|80.0|0.64|1.0||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_S versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.|
1585169|NCT03587207|2915183|Other|M14459 strain-Between group ratio for comparison of rMenBOMV_ACWY_S group and rMenBOMV group.|Geometric mean ratio|1.05|||||2-Sided|80.0|0.83|1.32||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_S versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.|
1585170|NCT03587207|2915183|Other|Serogroup Y- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|0.98|||||2-Sided|80.0|0.7|1.38||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis serogroup Y, one month after first vaccination.|
1585171|NCT03587207|2915183|Other|Serogroup W- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|1.34|||||2-Sided|80.0|1.04|1.72||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis serogroup W, one month after first vaccination.|
1585172|NCT03587207|2915183|Other|Serogroup C- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|1.22|||||2-Sided|80.0|0.91|1.65||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis serogroup C, one month after first vaccination.|
1585470|NCT03569202|2915462|Other||Mean Difference (Final Values)|-17.0625||||0.0038|2-Sided|95.0|-27.928|-6.197||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline|
1585173|NCT03587207|2915183|Other|Serogroup A- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|0.46|||||2-Sided|80.0|0.35|0.62||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis serogroup A, one month after first vaccination.|
1585174|NCT03587207|2915183|Other|M07-0241084 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|0.86|||||2-Sided|80.0|0.68|1.07||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.|
1585175|NCT03587207|2915183|Other|NZ98/254 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|0.78|||||2-Sided|80.0|0.61|1.0||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after first vaccination.|
1585176|NCT03587207|2915183|Other|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|0.73|||||2-Sided|80.0|0.58|0.9||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.|
1585177|NCT03587207|2915183|Other|M14459 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|0.87|||||2-Sided|80.0|0.69|1.09||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.|
1585178|NCT03587207|2915183|Other|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV+ACWY_D group.|Geometric mean ratio|0.76|||||2-Sided|80.0|0.54|1.08||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis serogroup Y, one month after first vaccination.|
1585179|NCT03587207|2915183|Other|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV+ACWY_D group.|Geometric mean ratio|0.88|||||2-Sided|80.0|0.68|1.13||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis serogroup W, one month after first vaccination.|
1585180|NCT03587207|2915183|Other|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV+ACWY_D Group.|Geometric mean ratio|0.84|||||2-Sided|80.0|0.62|1.13||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis serogroup C, one month after first vaccination.|
1585181|NCT03587207|2915183|Other|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV+ACWY_D group.|Geometric mean ratio|0.77|||||2-Sided|80.0|0.58|1.03||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis serogroup A, one month after first vaccination.|
1585182|NCT03587207|2915183|Other|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV+ACWY_D group.|Odds Ratio (OR)|1.08|||||2-Sided|80.0|0.87|1.36||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after first vaccination.|
1585183|NCT03587207|2915183|Other|NZ98/254 strain- Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV+ACWY_D group.|Geometric mean ratio|1.01|||||2-Sided|80.0|0.8|1.29||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis B NZ98/254 (PorA)strain, one month after first vaccination.|
1585184|NCT03587207|2915183|Other|96217 strain- Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV+ACWY_D group.|Geometric mean ratio|0.93|||||2-Sided|80.0|0.75|1.15||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis B 96217 (NadA) strain, one month after first vaccination.|
1585185|NCT03587207|2915183|Other|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV+ACWY_D group.|Geometric mean ratio|1.29|||||2-Sided|80.0|1.02|1.63||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis B M14459 (fHbp) strain, one month after first vaccination.|
1585186|NCT03587207|2915184|Other|Between group ratio is calculated as GMT for rMenBOMV+ACWY_S Group over GMT for rMenBOMV+ACWY_D Group. 80% CI are obtained from Analysis of Covariance model fitted to pooled Serogroup B Strains. The following ANCOVA model is used: fixed-effect model including age strata, study group, strain and center as fixed effects. The pre vaccination (Baseline) log-transformed titer with centering at zero is included as a continuous covariate.|Geometric mean ratio|1.02|||||2-Sided|80.0|0.86|1.22||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the pooled B strains, one month after first vaccination.|
1585187|NCT03587207|2915188|Other|Serogroup Y- Between group ratio for comparison of MenABCWY group and MenACWY group|Geometric mean ratio|2.38|||||2-Sided|80.0|1.81|3.12||||||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.|
1585188|NCT03587207|2915188|Other|Serogroup W- Between group ratios for comparison of MenABCWY group and MenACWY group|Geometric mean ratio|3.25|||||2-Sided|80.0|2.66|3.96||||||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.|
1585189|NCT03587207|2915188|Other|Serogroup C- Between group ratios for comparison of MenABCWY group and MenACWY group|Odds Ratio (OR)|4.99|||||2-Sided|80.0|3.92|6.35||||||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.|
1585190|NCT03587207|2915188|Other|Serogroup A- Between group ratios for comparison between MenABCWY group and MenACWY group|Geometric mean ratio|2.02|||||2-Sided|80.0|1.62|2.51||||||To investigate possible effects on the immune response based on strains common to MenABCWY versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.|
1585191|NCT03587207|2915188|Other|M07-0241084 strain-Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.52|||||2-Sided|80.0|0.42|0.63||||||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.|
1585192|NCT03587207|2915188|Other|NZ98/254 strain-Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|0.62|||||2-Sided|80.0|0.5|0.76||||||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.|
1585193|NCT03587207|2915188|Other|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV group.|Geometric mean ratio|0.71|||||2-Sided|80.0|0.59|0.86||||||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.|
1585194|NCT03587207|2915188|Other|M14459- Between group ratios for comparison of MenABCWY group and rMenBOMV group|Geometric mean ratio|1.05|||||2-Sided|80.0|0.87|1.25||||||To investigate possible effects on the immune response based on strains common to MenABCWY versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.|
1585195|NCT03587207|2915188|Other|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY_D group and MenACWY group.|Geometric mean ratio|2.22|||||2-Sided|80.0|1.68|2.92||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_D versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.|
1585196|NCT03587207|2915188|Other|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY_D group and MenACWY group.|Geometric mean ratio|3.17|||||2-Sided|80.0|2.6|3.87||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_D versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.|
1585197|NCT03587207|2915188|Other|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY_D group and MenACWY group.|Geometric mean ratio|4.19|||||2-Sided|80.0|3.3|5.34||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_D versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.|
1585198|NCT03587207|2915188|Other|Serogroup A-Between group ratio for comparison of rMenBOMV+ACWY_D group and MenACWY group.|Geometric mean ratio|3.92|||||2-Sided|80.0|3.15|4.88||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_D versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.|
1585199|NCT03587207|2915188|Other|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY_D group and rMenBOMV group.|Geometric mean ratio|0.89|||||2-Sided|80.0|0.73|1.09||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_D versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.|
1585200|NCT03587207|2915188|Other|NZ98/254 strain-Between group ratio for comparison of rMenBOMV+ACWY_D group and rMenBOMV group.|Geometric mean ratio|1.01|||||2-Sided|80.0|0.82|1.24||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_D versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.|
1585201|NCT03587207|2915188|Other|96217 strain- Between group ratios for comparison of rMenBOMV+ACWY_D group and rMenBOMV group|Geometric mean ratio|0.86|||||2-Sided|80.0|0.71|1.04||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_D versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.|
1585202|NCT03587207|2915188|Other|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY_D group and rMenBOMV group.|Geometric mean ratio|1.02|||||2-Sided|80.0|0.85|1.22||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_D versus rMenBOMV study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.|
1585203|NCT03587207|2915188|Other|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY_S group and MenACWY group.|Geometric mean ratio|2.01|||||2-Sided|80.0|1.53|2.65||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_S versus MenACWY study groups, on the Meningitis serogroup Y, one month after last vaccination.|
1585204|NCT03587207|2915188|Other|Serogroup W- Between group ratio for comparison of rMenBOMV+ACWY_S group and MenACWY group.|Geometric mean ratio|3.07|||||2-Sided|80.0|2.52|3.73||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_S versus MenACWY study groups, on the Meningitis serogroup W, one month after last vaccination.|
1585205|NCT03587207|2915188|Other|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY_S group and MenACWY group.|Geometric mean ratio|4.18|||||2-Sided|80.0|3.28|5.31||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_S versus MenACWY study groups, on the Meningitis serogroup C, one month after last vaccination.|
1585206|NCT03587207|2915188|Other|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY_S group and MenACWY group.|Geometric mean ratio|3.6|||||2-Sided|80.0|2.9|4.47||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_S versus MenACWY study groups, on the Meningitis serogroup A, one month after last vaccination.|
1585207|NCT03587207|2915188|Other|M07-0241084 strain-Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV group.|Geometric mean ratio|0.71|||||2-Sided|80.0|0.58|0.86||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_S versus rMenBOMV study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.|
1585208|NCT03587207|2915188|Other|NZ98/254 strain-Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV group.|Geometric mean ratio|0.78|||||2-Sided|80.0|0.64|0.96||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_S versus rMenBOMV study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.|
1585209|NCT03587207|2915188|Other|96217 strain-Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV group.|Geometric mean ratio|0.9|||||2-Sided|80.0|0.75|1.09||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_S versus rMenBOMV study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.|
1585210|NCT03587207|2915188|Other|M14459 strain- Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV group.|Geometric mean ratio|1.02|||||2-Sided|80.0|0.85|1.22||||||To investigate possible effects on the immune response based on strains common to rMenBOMV+ACWY_S versus rMenBOMV study groups, on the Meningitis B M14459(fHbp) strain, one month after last vaccination.|
1585504|NCT03569033|2915479|Other||Difference in Least Squares Means|0.99||||0.754|2-Sided|95.0|-5.33|7.3|||ANCOVA||||
1585211|NCT03587207|2915188|Other|Serogroup Y- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|1.18|||||2-Sided|80.0|0.9|1.55||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis serogroup Y, one month after last vaccination.|
1585212|NCT03587207|2915188|Other|Serogroup W- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|1.06|||||2-Sided|80.0|0.87|1.29||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis serogroup W, one month after last vaccination.|
1585213|NCT03587207|2915188|Other|Serogroup C- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|1.19|||||2-Sided|80.0|0.94|1.52||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis serogroup C, one month after last vaccination.|
1585214|NCT03587207|2915188|Other|Serogroup A- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|0.56|||||2-Sided|80.0|0.45|0.69||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis serogrpoup A, one month after last vaccination.|
1585215|NCT03587207|2915188|Non-Inferiority|M07-0241084 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|0.73|||||2-Sided|80.0|0.6|0.88||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.|
1585216|NCT03587207|2915188|Other|NZ98/254 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|0.79|||||2-Sided|80.0|0.65|0.97||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.|
1585217|NCT03587207|2915188|Other|96217 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|0.79|||||2-Sided|80.0|0.66|0.95||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis B 96217 (NadA)strain, one month after last vaccination.|
1585218|NCT03587207|2915188|Other|M14459 strain- Between group ratio for comparison of MenABCWY group and rMenBOMV+ACWY_S group.|Geometric mean ratio|1.02|||||2-Sided|80.0|0.86|1.22||||||Other unknown interference in MenABCWY versus rMenBOMV+ACWY_S study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.|
1585219|NCT03587207|2915188|Other|Serogroup Y- Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV+ACWY_D group|Geometric mean ratio|0.91|||||2-Sided|80.0|0.69|1.19||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis serogroup Y, one month after last vaccination.|
1585220|NCT03587207|2915188|Other|Serogroup W- Between group ratios for comparison of rMenBOMV+ACWY_S group and rMenBOMV+ACWY_D group|Geometric mean ratio|0.97|||||2-Sided|80.0|0.79|1.18||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis serogroup W, one month after last vaccination.|
1585221|NCT03587207|2915188|Other|Serogroup C- Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV+ACWY_D group|Geometric mean ratio|1.0|||||2-Sided|80.0|0.78|1.27||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis serogroup C, one month after last vaccination.|
1585222|NCT03587207|2915188|Other|Serogroup A- Between group ratio for comparison of rMenBOMV+ACWY_S group and rMenBOMV+ACWY_D group|Geometric mean ratio|0.92|||||2-Sided|80.0|0.74|1.14||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis serogroup A, one month after last vaccination.|
1585223|NCT03587207|2915188|Other|M07-0241084 strain- Between group ratios for comparison of rMenBOMV_ACWY_S group and rMenBOMV+ACWY_D group|Geometric mean ratio|0.8|||||2-Sided|80.0|0.66|0.96||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis B M07-0241084 (NHBA) strain, one month after last vaccination.|
1585224|NCT03587207|2915188|Other|NZ98/254 strain-Between group ratios for comparison of rMenBOMV+ACWY_S and rMenBOMV+ACWY_D groups|Geometric mean ratio|0.78|||||2-Sided|80.0|0.64|0.95||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis B NZ98/254 (PorA) strain, one month after last vaccination.|
1585225|NCT03587207|2915188|Other|96217 strain-Between group ratios for comparison of rMenBOMV+ACWY_S and rMenBOMV+ACWY_D groups|Geometric mean ratio|1.05||||||80.0|0.88|1.26||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis B 96217 (NadA) strain, one month after last vaccination.|
1585226|NCT03587207|2915188|Other|M14459 strain-Between group ratios for comparison of rMenBOMV+ACWY_S and rMenBOMV+ACWY_D groups|Geometric mean ratio|1.0|||||2-Sided|80.0|0.84|1.2||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the Meningitis B M14459 (fHbp) strain, one month after last vaccination.|
1585227|NCT03587207|2915189|Other|rMenBOMV+ACWY_S is to be declared statistically inferior if the 2-sided 80% CIs of the between group ratio of the GMT with rMenBOMV+ACWY_D as control is lower than 1 at 1 month after last vaccination. The following ANCOVA model is used: fixed-effect model including age strata, study group, strain and center as fixed effects. The pre vaccination (Baseline) log-transformed titer with centering at zero is included as a continuous covariate.|Geometric mean ratio|0.96|||||2-Sided|80.0|0.83|1.1||||||Immune interference due to stress to lymph nodes (lymph-node effect) in rMenBOMV+ACWY_S versus rMenBOMV+ACWY_D study groups, on the pooled B strains, one month after last vaccination.|
1585228|NCT03586830|2915193|Superiority||Difference of LS Means|-7.23|Standard Error of the Mean|0.748|<|0.001|2-Sided|95.0|-8.7|-5.75|||Hochberg Approach||||
1585229|NCT03586830|2915193|Superiority||Difference of LS Means|-5.85|Standard Error of the Mean|0.755|<|0.001|2-Sided|95.0|-7.34|-4.36|||Hochberg Approach||||
1585230|NCT03586830|2915193|Superiority||Difference of least square (LS) means|-4.56|Standard Error of the Mean|0.757|<|0.001|2-Sided|95.0|-6.05|-3.06|||Hochberg Approach||||
1585285|NCT03575871|2915351|Superiority||Difference in LS mean|-2.6|||<|0.0001|2-Sided|95.0|-3.3|-1.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585231|NCT03586648|2915208|Non-Inferiority|Statistically superiority will be concluded if the lower limit of the confidence intervals of the Test lens is greater than -5 points.|Least-square Mean Difference|-11.5|Standard Error of the Mean|4.14|||2-Sided|95.0|-19.7|-3.3|||||Mean difference was calculated as Test minus Control.|The non-inferiority of the Test lens relative to the Control will be concluded if the lower confidence limit of LSM difference is above the non-inferiority margin -5.|
1585232|NCT03586648|2915209|Superiority|Statistically superiority will be concluded if the lower limit of the confidence intervals of the Test lens is greater than 32 points.|Least-square Mean|39.3|Standard Error of the Mean|3.31|||2-Sided|95.0|32.7|45.9||||||Data only from the first period will be used if period effect is significant.|
1585233|NCT03585790|2915228|Non-Inferiority|Margin acceptable mean difference (Single Vision - Multifocal) = -5 rating units (0-100 scale, 0 = optimal)||||||0.18|||||||t-test, 1 sided|||Ho: Single Vision - Multifocal >= M vs. Ho: Single Vision - Multifocal < M. Alpha = 0.05, two sided beta = 0.80|
1585234|NCT03583385|2915254|Equivalence|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric Means|106.78|||||2-Sided|90.0|98.99|115.19|||||||
1585235|NCT03583385|2915255|Equivalence|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|% Ratio of Geometric Means|103.42|||||2-Sided|90.0|95.18|112.37|||||||
1585236|NCT03582943|2915256|Superiority|Test of interaction between presence of co-morbidities and RLIC vs. sham conditioning|Mean Difference (Net)|4.12||||0.29|2-Sided||||||Mixed Models Analysis||||
1585237|NCT03582943|2915256|Superiority||Mean Difference (Net)|0.25||||0.233|2-Sided|||||Test of interaction between BMI and RLIC vs. sham conditioning|Mixed Models Analysis||||
1585238|NCT03582943|2915256|Superiority||Mean Difference (Final Values)|0.0||||0.803|2-Sided|||||Test of interaction between sex and RLIC vs. sham conditioning|Mixed Models Analysis||||
1585239|NCT03582943|2915256|Superiority||Mean Difference (Net)|-0.023||||0.455|2-Sided|||||Test of interaction between age and RLIC vs. sham|Mixed Models Analysis||||
1585240|NCT03582943|2915256|Superiority|A priori power analyses was designed to detect at least a 3 second difference in change in balance scores between groups.|Mean Difference (Net)|0.74||||0.984|2-Sided|||||Test of differences between groups.|Mixed Models Analysis||||
1585241|NCT03582813|2915258|Superiority||Odds Ratio (OR)|4.14|||<|0.01|2-Sided|95.0|1.5|11.44|||Regression, Logistic|||This mixed effects random regression analysis tested whether intervention participants would report greater likelihood of enrollment in educational classes that would be maintained longitudinally|
1585242|NCT03582813|2915259|Superiority||Odds Ratio (OR)|2.19||||0.046|2-Sided|95.0|1.01|4.74|||Regression, Logistic|||This mixed effects random regression analysis tested whether intervention participants would report greater likelihood of employment that would be maintained longitudinally|
1585243|NCT03582813|2915260|Superiority||MIXREG Estimate|0.29|Standard Error of the Mean|0.13||0.03|2-Sided||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in perceived autonomy support that would be maintained longitudinally|
1585244|NCT03582813|2915261|Superiority||MIXREG Estimate|0.12|Standard Error of the Mean|0.04|<|0.01|2-Sided||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in coping mastery that would be maintained longitudinally|
1585245|NCT03582813|2915262|Superiority||MIXREG Estimate|0.9|Standard Error of the Mean|0.42||0.031|2-Sided||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-esteem that would be maintained longitudinally|
1585246|NCT03582813|2915263|Superiority||MIXREG Estimate|4.27|Standard Error of the Mean|1.61|<|0.01|2-Sided||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-perceived Recovery and that this effect would be maintained overtime;|
1585247|NCT03581825|2915278|Non-Inferiority|The non-inferiority of the Test lens relative to the Control was concluded if the lower confidence limit of LSM difference was above the non-inferiority margin -5.|Least-Square Mean Difference|3.4|Standard Error of the Mean|2.0|||2-Sided|95.0|-0.5|7.4|||||Mean Difference was calculated as Test minus Control||
1585248|NCT03581825|2915279|Superiority|Statistically superiority was concluded if the lower limit of the confidence intervals of the Test lens are greater than 40 points.|Least-Square Mean|56.3|Standard Error of the Mean|2.55|||2-Sided|95.0|51.2|61.4|||||||
1585249|NCT03578146|2915323|Superiority||Least Squares Means (Difference)|-19.33|||<|0.0001|2-Sided||||||ANCOVA||||
1585250|NCT03578146|2915323|Superiority||Least Squares Means (Difference)|-17.05|||<|0.0001|2-Sided||||||ANCOVA||||
1585251|NCT03578146|2915323|Superiority||Least Squares Means (Difference)|-17.53|||<|0.0001|2-Sided||||||ANCOVA||||
1585252|NCT03578146|2915323|Superiority||Least Squares Means (Difference)|-15.06|||<|0.0001|2-Sided||||||ANCOVA||||
1585253|NCT03578146|2915323|Superiority||Least Squares Means (Difference)|-9.91|||<|0.002|2-Sided||||||ANCOVA||||
1585254|NCT03578146|2915324|Superiority||Least Squares Means (Difference)|270297.2|||<|0.0001|2-Sided||||||ANCOVA||||
1585255|NCT03578146|2915324|Superiority||Least Squares Means (Difference)|263236.5|||<|0.0001|2-Sided||||||ANCOVA||||
1585256|NCT03578146|2915324|Superiority||Least Squares Means (Difference)|163880.7|||<|0.0001|2-Sided||||||ANCOVA||||
1585257|NCT03578146|2915324|Superiority||Least Squares Means (Difference)|110388.3|||<|0.0001|2-Sided||||||ANCOVA||||
1585258|NCT03578146|2915324|Superiority||Least Squares Means (Difference)|52837.94|||<|0.0001|2-Sided||||||ANCOVA||||
1585259|NCT03578146|2915325|Superiority||Least Squares Means (Difference)|-231.12|||<|0.0001|2-Sided||||||ANCOVA||||
1585260|NCT03578146|2915325|Superiority||Least Squares Means (Difference)|-239.3|||<|0.0001|2-Sided||||||ANCOVA||||
1585261|NCT03578146|2915325|Superiority||Least Squares Means (Difference)|-189.57|||<|0.0001|2-Sided||||||ANCOVA||||
1585262|NCT03578146|2915325|Superiority||Least Squares Means (Difference)|-153.99|||<|0.0001|2-Sided||||||ANCOVA||||
1585263|NCT03578146|2915325|Superiority||Least Squares Means (Difference)|-73.14|||<|0.0121|2-Sided||||||ANCOVA||||
1585264|NCT03577275|2915330|Other|||||||||||||||||"The primary analysis was based on concentration-QTc modeling of the relationship between icosabutate and delta delta QTcF, with the intent to exclude an effect > 10 msec at clinically relevant icosabutate plasma concentrations.~Assay sensitivity was evaluated by concentration-QTc analysis of the effect on delta delta QTcF of moxifloxacin using a similar model as for the primary analysis."|The primary analysis was based on concentration-QTc modeling of the relationship between icosabutate and delta delta QTcF, with the intent to exclude an effect > 10 msec at clinically relevant icosabutate plasma concentrations.
1585265|NCT03575962|2915346|Other||Ratio of geometric least square mean|1.1556|||||2-Sided|90.0|0.99|1.35|||||||
1585266|NCT03575962|2915347|Other||Ratio of geometric least square mean|1.1169|||||2-Sided|90.0|0.99|1.27|||||||
1585267|NCT03575871|2915349|Superiority||Difference in LS mean|-33.4|||<|0.0001|2-Sided|95.0|-42.6|-24.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585268|NCT03575871|2915349|Superiority||Difference in LS mean|-23.1|||<|0.0001|2-Sided|95.0|-32.3|-13.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585269|NCT03575871|2915349|Superiority||Difference in LS mean|-33.6|||<|0.0001|2-Sided|95.0|-41.0|-26.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585270|NCT03575871|2915349|Superiority||Difference in LS mean|-19.4|||<|0.0001|2-Sided|95.0|-26.8|-12.1|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585271|NCT03575871|2915349|Superiority||Difference in LS mean|-35.9|||<|0.0001|2-Sided|95.0|-42.3|-29.4|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585272|NCT03575871|2915349|Superiority||Difference in LS mean|-21.6|||<|0.0001|2-Sided|95.0|-28.1|-15.2|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585273|NCT03575871|2915349|Superiority||Difference in LS mean|-32.1|||<|0.0001|2-Sided|95.0|-37.9|-26.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585274|NCT03575871|2915349|Superiority||Difference in LS mean|-20.9|||<|0.0001|2-Sided|95.0|-26.6|-15.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585275|NCT03575871|2915350|Superiority||Difference in LS mean|-1.7|||<|0.0001|2-Sided|95.0|-2.5|-1.0|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585276|NCT03575871|2915350|Superiority||Difference in LS mean|-0.9|||<|0.0164|2-Sided|95.0|-1.7|-0.2|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585277|NCT03575871|2915350|Superiority||Difference in LS mean|-2.4|||<|0.0001|2-Sided|95.0|-3.1|-1.7|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585278|NCT03575871|2915350|Superiority||Difference in LS mean|-1.6|||<|0.0001|2-Sided|95.0|-2.3|-0.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585279|NCT03575871|2915350|Superiority||Difference in LS mean|-3.0|||<|0.0001|2-Sided|95.0|-3.6|-2.3|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585280|NCT03575871|2915350|Superiority||Difference in LS mean|-1.8|||<|0.0001|2-Sided|95.0|-2.4|-1.2|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585281|NCT03575871|2915350|Superiority||Difference in LS mean|-2.4|||<|0.0001|2-Sided|95.0|-3.0|-1.8|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585282|NCT03575871|2915350|Superiority||Difference in LS mean|-1.4|||<|0.0001|2-Sided|95.0|-2.0|-0.8|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585283|NCT03575871|2915351|Superiority||Difference in LS mean|-2.2|||<|0.0001|2-Sided|95.0|-3.0|-1.4|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585284|NCT03575871|2915351|Superiority||Difference in LS mean|-1.4|||<|0.0006|2-Sided|95.0|-2.2|-0.6|||Mixed Models Analysis|||Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585286|NCT03575871|2915351|Superiority||Difference in LS mean|-1.6|||<|0.0001|2-Sided|95.0|-2.3|-0.9|||Mixed Models Analysis|||Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585287|NCT03575871|2915351|Superiority||Difference in LS mean|-3.1|||<|0.0001|2-Sided|95.0|-3.8|-2.5|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585288|NCT03575871|2915351|Superiority||Difference in LS mean|-1.9|||<|0.0001|2-Sided|95.0|-2.6|-1.3|||Mixed Models Analysis|||Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585289|NCT03575871|2915351|Superiority||Difference in LS mean|-2.9|||<|0.0001|2-Sided|95.0|-3.5|-2.3|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585290|NCT03575871|2915351|Superiority||Difference in LS mean|-1.7|||<|0.0001|2-Sided|95.0|-2.3|-1.1|||Mixed Models Analysis|||Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585291|NCT03575871|2915352|Superiority||Difference in Percentage|27.6|||<|0.0001|2-Sided|95.0|19.3|35.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585292|NCT03575871|2915352|Superiority||Difference in Percentage|16.2|||<|0.0005|2-Sided|95.0|8.8|23.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585293|NCT03575871|2915352|Superiority||Difference in Percentage|25.7|||<|0.0001|2-Sided|95.0|18.3|33.1||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585294|NCT03575871|2915352|Superiority||Difference in Percentage|11.5|||<|0.0018|2-Sided|95.0|5.5|17.5||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585295|NCT03575871|2915352|Superiority||Difference in Percentage|17.7|||<|0.0001|2-Sided|95.0|10.9|24.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585296|NCT03575871|2915352|Superiority||Difference in Percentage|7.0|||<|0.0171|2-Sided|95.0|1.8|12.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585297|NCT03575871|2915352|Superiority||Difference in Percentage|5.2|||<|0.0451|2-Sided|95.0|0.3|10.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585298|NCT03575871|2915352|Superiority||Difference in Percentage|1.9|||<|0.2261|2-Sided|95.0|-2.2|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585299|NCT03575871|2915353|Superiority||Difference in Percentage|49.6|||<|0.0001|2-Sided|95.0|38.9|60.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585300|NCT03575871|2915353|Superiority||Difference in Percentage|36.2|||<|0.0001|2-Sided|95.0|25.4|47.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585301|NCT03575871|2915353|Superiority||Difference in Percentage|46.1|||<|0.0001|2-Sided|95.0|35.2|57.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585302|NCT03575871|2915353|Superiority||Difference in Percentage|28.0|||<|0.0001|2-Sided|95.0|17.0|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585303|NCT03575871|2915353|Superiority||Difference in Percentage|52.8|||<|0.0001|2-Sided|95.0|43.2|62.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585406|NCT03575702|2915382|Other||||||=|0|||||||ANCOVA||||
1585407|NCT03575702|2915383|Other||||||=|0|||||||ANCOVA||||
1585304|NCT03575871|2915353|Superiority||Difference in Percentage|28.3|||<|0.0001|2-Sided|95.0|18.5|38.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585305|NCT03575871|2915353|Superiority||Difference in Percentage|32.6|||<|0.0001|2-Sided|95.0|24.6|40.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585306|NCT03575871|2915353|Superiority||Difference in Percentage|12.7|||<|0.0011|2-Sided|95.0|6.5|18.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585307|NCT03575871|2915354|Superiority||Difference in Percentage|30.2|||<|0.0001|2-Sided|95.0|21.4|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585308|NCT03575871|2915354|Superiority||Difference in Percentage|18.5|||<|0.0003|2-Sided|95.0|10.5|26.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585309|NCT03575871|2915354|Superiority||Difference in Percentage|25.8|||<|0.0001|2-Sided|95.0|18.1|33.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585310|NCT03575871|2915354|Superiority||Difference in Percentage|14.5|||<|0.0008|2-Sided|95.0|7.7|21.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585311|NCT03575871|2915354|Superiority||Difference in Percentage|16.8|||<|0.0001|2-Sided|95.0|10.1|23.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585312|NCT03575871|2915354|Superiority||Difference in Percentage|6.5|||<|0.0227|2-Sided|95.0|1.4|11.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585313|NCT03575871|2915354|Superiority||Difference in Percentage|5.8|||<|0.0332|2-Sided|95.0|0.8|10.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585314|NCT03575871|2915354|Superiority||Difference in Percentage|1.9|||<|0.2353|2-Sided|95.0|-2.2|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585315|NCT03575871|2915355|Superiority||Difference in LS mean|-48.2|||<|0.0001|2-Sided|95.0|-60.4|-36.0|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585316|NCT03575871|2915355|Superiority||Difference in LS mean|-39.6|||<|0.0001|2-Sided|95.0|-51.8|-27.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585317|NCT03575871|2915355|Superiority||Difference in LS mean|-40.6|||<|0.0001|2-Sided|95.0|-52.2|-28.9|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585318|NCT03575871|2915355|Superiority||Difference in LS mean|-32.9|||<|0.0001|2-Sided|95.0|-44.6|-21.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585319|NCT03575871|2915355|Superiority||Difference in LS mean|-40.5|||<|0.0001|2-Sided|95.0|-49.8|-31.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585320|NCT03575871|2915355|Superiority||Difference in LS mean|-29.7|||<|0.0001|2-Sided|95.0|-39.0|-20.4|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585321|NCT03575871|2915355|Superiority||Difference in LS mean|-34.1|||<|0.0001|2-Sided|95.0|-43.1|-25.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585465|NCT03570047|2915445|Other||Hazard Ratio (HR)|0.72||||0.0012|2-Sided|95.0|0.591|0.879|||Cox proportional hazards model||||
1585322|NCT03575871|2915355|Superiority||Difference in LS mean|-26.5|||<|0.0001|2-Sided|95.0|-35.5|-17.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585323|NCT03575871|2915356|Superiority||Difference in LS mean|-44.7|||<|0.0001|2-Sided|95.0|-56.4|-33.0|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585324|NCT03575871|2915356|Superiority||Difference in LS mean|-31.4|||<|0.0001|2-Sided|95.0|-43.1|-19.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585325|NCT03575871|2915356|Superiority||Difference in LS mean|-40.2|||<|0.0001|2-Sided|95.0|-50.0|-30.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585326|NCT03575871|2915356|Superiority||Difference in LS mean|-26.4|||<|0.0001|2-Sided|95.0|-36.2|-16.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585327|NCT03575871|2915356|Superiority||Difference in LS mean|-44.6|||<|0.0001|2-Sided|95.0|-52.8|-36.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585328|NCT03575871|2915356|Superiority||Difference in LS mean|-29.9|||<|0.0001|2-Sided|95.0|-38.1|-21.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585329|NCT03575871|2915356|Superiority||Difference in LS mean|-42.3|||<|0.0001|2-Sided|95.0|-50.3|-34.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585330|NCT03575871|2915356|Superiority||Difference in LS mean|-30.2|||<|0.0001|2-Sided|95.0|-38.1|-22.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1585331|NCT03575871|2915357|Superiority||Difference in Percentage|7.0||||0.018|2-Sided|95.0|1.8|12.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585332|NCT03575871|2915357|Superiority||Difference in Percentage|5.2||||0.0419|2-Sided|95.0|0.3|10.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585333|NCT03575871|2915357|Superiority||Difference in Percentage|3.8||||0.081|2-Sided|95.0|-0.7|8.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585334|NCT03575871|2915357|Superiority||Difference in Percentage|1.3||||0.3207|2-Sided|95.0|-2.7|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585335|NCT03575871|2915357|Superiority||Difference in Percentage|3.9||||0.081|2-Sided|95.0|-0.8|8.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585336|NCT03575871|2915357|Superiority||Difference in Percentage|1.3||||0.3207|2-Sided|95.0|-2.7|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585337|NCT03575871|2915357|Superiority||Difference in Percentage|1.3||||0.3261|2-Sided|95.0|-2.8|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585338|NCT03575871|2915357|Superiority||Difference in Percentage|0.0|||||2-Sided|95.0|-3.7|3.7||||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585339|NCT03575871|2915358|Superiority||Difference in Percentage|33.5|||<|0.0001|2-Sided|95.0|24.6|42.5|||Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585340|NCT03575871|2915358|Superiority||Difference in Percentage|20.1|||<|0.0001|2-Sided|95.0|11.9|28.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1597162|NCT02915835|2935781|Superiority|||||||0.27|||||||ANCOVA||||
1585341|NCT03575871|2915358|Superiority||Difference in Percentage|31.6|||<|0.0001|2-Sided|95.0|23.1|40.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585342|NCT03575871|2915358|Superiority||Difference in Percentage|14.6|||<|0.0013|2-Sided|95.0|7.2|22.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585343|NCT03575871|2915358|Superiority||Difference in Percentage|22.9|||<|0.0001|2-Sided|95.0|15.5|30.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585344|NCT03575871|2915358|Superiority||Difference in Percentage|9.7|||<|0.0049|2-Sided|95.0|4.0|15.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585345|NCT03575871|2915358|Superiority||Difference in Percentage|9.1|||<|0.007|2-Sided|95.0|3.4|14.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585346|NCT03575871|2915358|Superiority||Difference in Percentage|2.5|||<|0.1623|2-Sided|95.0|-1.7|6.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585347|NCT03575871|2915359|Superiority||Difference in Percentage|60.1|||<|0.0001|2-Sided|95.0|49.1|71.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585348|NCT03575871|2915359|Superiority||Difference in Percentage|48.7|||<|0.0001|2-Sided|95.0|37.2|60.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585349|NCT03575871|2915359|Superiority||Difference in Percentage|47.6|||<|0.0001|2-Sided|95.0|35.7|59.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585350|NCT03575871|2915359|Superiority||Difference in Percentage|31.5|||<|0.0001|2-Sided|95.0|18.8|44.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585351|NCT03575871|2915359|Superiority||Difference in Percentage|49.8|||<|0.0001|2-Sided|95.0|37.8|61.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585352|NCT03575871|2915359|Superiority||Difference in Percentage|30.2|||<|0.0001|2-Sided|95.0|17.5|42.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585353|NCT03575871|2915359|Superiority||Difference in Percentage|44.2|||<|0.0001|2-Sided|95.0|33.9|54.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585354|NCT03575871|2915359|Superiority||Difference in Percentage|25.0|||<|0.0001|2-Sided|95.0|14.8|35.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585355|NCT03575871|2915360|Superiority||Difference in Percentage|6.3||||0.0244|2-Sided|95.0|1.2|11.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585356|NCT03575871|2915360|Superiority||Difference in Percentage|5.2||||0.0419|2-Sided|95.0|0.3|10.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585357|NCT03575871|2915360|Superiority||Difference in Percentage|4.5||||0.0586|2-Sided|95.0|-0.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585466|NCT03570047|2915445|Other||Hazard Ratio (HR)|0.71||||0.0001|2-Sided|95.0|0.592|0.842|||Cox proportional hazards model||||
1585467|NCT03570047|2915445|Other||Hazard Ratio (HR)|0.79||||0.0291|2-Sided|95.0|0.642|0.977|||Cox proportional hazards model||||
1585358|NCT03575871|2915360|Superiority||Difference in Percentage|1.3||||0.3207|2-Sided|95.0|-2.7|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585359|NCT03575871|2915360|Superiority||Difference in Percentage|4.5||||0.0597|2-Sided|95.0|-0.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585360|NCT03575871|2915360|Superiority||Difference in Percentage|1.9||||0.2223|2-Sided|95.0|-2.2|6.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585361|NCT03575871|2915360|Superiority||Difference in Percentage|1.9||||0.2262|2-Sided|95.0|-2.2|6.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585362|NCT03575871|2915360|Superiority||Difference in Percentage|0.0|||||2-Sided|95.0|-3.7|3.7||||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585363|NCT03575871|2915361|Superiority||Difference in Percentage|26.9|||<|0.0001|2-Sided|95.0|17.0|36.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585364|NCT03575871|2915361|Superiority||Difference in Percentage|11.9|||<|0.0246|2-Sided|95.0|2.4|21.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585365|NCT03575871|2915361|Superiority||Difference in Percentage|31.8|||<|0.0001|2-Sided|95.0|23.6|39.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585366|NCT03575871|2915361|Superiority||Difference in Percentage|12.9|||<|0.0019|2-Sided|95.0|6.3|19.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585367|NCT03575871|2915361|Superiority||Difference in Percentage|14.2|||<|0.0005|2-Sided|95.0|7.8|20.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585368|NCT03575871|2915361|Superiority||Difference in Percentage|5.1|||<|0.0459|2-Sided|95.0|0.2|10.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585369|NCT03575871|2915362|Superiority||Difference in Percentage|47.4|||<|0.0001|2-Sided|95.0|36.8|58.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585370|NCT03575871|2915362|Superiority||Difference in Percentage|30.4|||<|0.0001|2-Sided|95.0|19.7|41.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585371|NCT03575871|2915362|Superiority||Difference in Percentage|44.3|||<|0.0001|2-Sided|95.0|34.8|53.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585372|NCT03575871|2915362|Superiority||Difference in Percentage|20.0|||<|0.0004|2-Sided|95.0|10.9|29.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585373|NCT03575871|2915362|Superiority||Difference in Percentage|22.7|||<|0.0001|2-Sided|95.0|15.0|30.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585374|NCT03575871|2915362|Superiority||Difference in Percentage|8.8|||<|0.015|2-Sided|95.0|2.8|14.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585375|NCT03575871|2915364|Superiority||Difference in LS mean|-2.2|||<|0.0001|2-Sided|95.0|-2.8|-1.6|||Mixed Models Analysis|||Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585376|NCT03575871|2915364|Superiority||Difference in LS mean|-1.7|||<|0.0001|2-Sided|95.0|-2.3|-1.1|||Mixed Models Analysis|||Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment by visit interaction, randomization strata (baseline disease severity and age category), baseline value and an unstructured covariance matrix.|
1585377|NCT03575871|2915365|Superiority||Difference in Percentage|38.6|||<|0.0001|2-Sided|95.0|28.1|49.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585378|NCT03575871|2915365|Superiority||Difference in Percentage|29.3|||<|0.0001|2-Sided|95.0|18.9|39.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585379|NCT03575871|2915365|Superiority||Difference in Percentage|39.8|||<|0.0001|2-Sided|95.0|28.9|50.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585380|NCT03575871|2915365|Superiority||Difference in Percentage|27.4|||<|0.0001|2-Sided|95.0|16.8|38.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585381|NCT03575871|2915365|Superiority||Difference in Percentage|46.4|||<|0.0001|2-Sided|95.0|37.2|55.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585382|NCT03575871|2915365|Superiority||Difference in Percentage|27.5|||<|0.0001|2-Sided|95.0|18.9|36.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585383|NCT03575871|2915365|Superiority||Difference in Percentage|31.2|||<|0.0001|2-Sided|95.0|22.3|40.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585384|NCT03575871|2915365|Superiority||Difference in Percentage|19.2|||<|0.0002|2-Sided|95.0|11.0|27.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585385|NCT03575871|2915366|Superiority||Difference in Percentage|50.5|||<|0.0001|2-Sided|95.0|40.0|60.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585386|NCT03575871|2915366|Superiority||Difference in Percentage|33.9|||<|0.0001|2-Sided|95.0|23.3|44.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585387|NCT03575871|2915367|Superiority||Difference in Percentage|28.7|||<|0.0001|2-Sided|95.0|18.6|38.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585388|NCT03575871|2915367|Superiority||Difference in Percentage|19.3|||<|0.0008|2-Sided|95.0|9.6|29.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1585389|NCT03575702|2915375|Other||||||=|0|||||||Chi-squared||||
1585390|NCT03575702|2915376|Other||||||=|0|||||||t-test, 1 sided|Change week 12|||
1585391|NCT03575702|2915377|Other||||||=|0|||||||t-test, 1 sided|Change week 12|||
1585392|NCT03575702|2915378|Other||||||=|0|||||||ANCOVA|Week 8 changes|||
1585393|NCT03575702|2915378|Other||||||=|0|||||||ANCOVA|Week 4 changes|||
1585394|NCT03575702|2915378|Other||||||=|0|||||||ANCOVA|Week 2 changes|||
1585395|NCT03575702|2915379|Other|||||||0.0008|||||||ANCOVA||||
1585396|NCT03575702|2915380|Other||||||<|0.0001|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 8|||
1585397|NCT03575702|2915380|Other||||||<|0.0001|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 4|||
1585398|NCT03575702|2915380|Other||||||=|0|||||||ANCOVA|Changes in nighttime number of daily incontinence episodes - week 2|||
1585399|NCT03575702|2915380|Other||||||=|0|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 8|||
1585400|NCT03575702|2915380|Other||||||=|0|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 4|||
1585401|NCT03575702|2915380|Other||||||=|0|||||||ANCOVA|Changes in daytime number of daily incontinence episodes - week 2|||
1585402|NCT03575702|2915380|Other||||||<|0.0001|||||||ANCOVA|Changes in number of daily incontinence episodes - week 8|||
1585403|NCT03575702|2915380|Other||||||=|0|||||||ANCOVA|Changes in number of daily incontinence episodes - week 4|||
1585404|NCT03575702|2915380|Other||||||<|0.0001|||||||ANCOVA|Changes in number of daily incontinence episodes - week 2|||
1585405|NCT03575702|2915381|Other||||||<|0.0001|||||||ANCOVA||||
1585408|NCT03575702|2915384|Non-Inferiority|The non-inferiority margin is considered as change in mean daily urination episodes of 0,8 episodes per day|Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.34|=|0|1-Sided|95.0||0.38|||ANCOVA|The number of urination episodes at the initiation of therapy is used as covariate, and the therapy group is used as a factor.||"The null hypothesis is that effect of Urotol according to the assessment of mean daily urination episodes exceeds effect of Uritos.~A sample containing of 222 patients (111 per study group) is considered sufficient to prove the alternative hypothesis at the significance level 0.025% and study power 80%. Given the expected drop out rate during the treatment period, the total number of patients to be randomized is 300 (150 in each group)."|
1585409|NCT03572972|2915400|Superiority||Hazard Ratio (HR)|0.882|||||2-Sided|95.0|0.754|1.032||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585410|NCT03572972|2915400|Superiority||Hazard Ratio (HR)|0.802|||||2-Sided|95.0|0.678|0.947||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585411|NCT03572972|2915400|Superiority||Hazard Ratio (HR)|0.881|||||2-Sided|95.0|0.732|1.061||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585412|NCT03572972|2915401|Superiority||Hazard Ratio (HR)|0.838|||||2-Sided|95.0|0.622|1.13|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585413|NCT03572972|2915401|Superiority||Hazard Ratio (HR)|0.64|||||2-Sided|95.0|0.534|0.766||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585414|NCT03572972|2915401|Superiority||Hazard Ratio (HR)|0.581|||||2-Sided|95.0|0.481|0.701||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585415|NCT03572972|2915402|Superiority||Hazard Ratio (HR)|0.771|||||2-Sided|95.0|0.578|1.027||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585416|NCT03572972|2915402|Superiority||Hazard Ratio (HR)|0.918|||||2-Sided|95.0|0.691|1.218||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585417|NCT03572972|2915402|Superiority||Hazard Ratio (HR)|1.204|||||2-Sided|95.0|0.871|1.666||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585418|NCT03572972|2915403|Superiority||Hazard Ratio (HR)|0.664|||||2-Sided|95.0|0.507|0.87||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585419|NCT03572972|2915403|Superiority||Hazard Ratio (HR)|0.538|||||2-Sided|95.0|0.392|0.737||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585468|NCT03570047|2915445|Other||Hazard Ratio (HR)|0.65|||<|0.0001|2-Sided|95.0|0.558|0.766|||Cox proportional hazards model||||
1585469|NCT03569202|2915462|Other||Mean Difference (Final Values)|-15.0714||||0.0011|2-Sided|95.0|-23.285|-6.8579||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline|
1585420|NCT03572972|2915403|Superiority||Hazard Ratio (HR)|0.373|||||2-Sided|95.0|0.212|0.658|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585421|NCT03572972|2915404|Superiority||Hazard Ratio (HR)|0.936|||||2-Sided|95.0|0.801|1.094||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585422|NCT03572972|2915404|Superiority||Hazard Ratio (HR)|0.697|||||2-Sided|95.0|0.586|0.83||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585423|NCT03572972|2915404|Superiority||Hazard Ratio (HR)|0.751|||||2-Sided|95.0|0.62|0.91||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585424|NCT03572972|2915405|Superiority||Hazard Ratio (HR)|1.295|||||2-Sided|95.0|0.92|1.824|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585425|NCT03572972|2915405|Superiority||Hazard Ratio (HR)|1.046|||||2-Sided|95.0|0.719|1.522|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585426|NCT03572972|2915405|Superiority||Hazard Ratio (HR)|0.6|||||2-Sided|95.0|0.492|0.731||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585427|NCT03572972|2915406|Superiority||Hazard Ratio (HR)|0.932|||||2-Sided|95.0|0.498|1.747||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585428|NCT03572972|2915406|Superiority||Hazard Ratio (HR)|0.692|||||2-Sided|95.0|0.342|1.402||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585429|NCT03572972|2915406|Superiority||Hazard Ratio (HR)|0.745|||||2-Sided|95.0|0.343|1.615||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585430|NCT03572972|2915407|Superiority||Hazard Ratio (HR)|0.422|||||2-Sided|95.0|0.247|0.722||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585431|NCT03572972|2915407|Superiority||Hazard Ratio (HR)|0.38|||||2-Sided|95.0|0.203|0.711||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585432|NCT03572972|2915407|Superiority||Hazard Ratio (HR)|0.25|||||2-Sided|95.0|0.119|0.523||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1597163|NCT02915835|2935782|Superiority|||||||0.66|||||||ANCOVA||||
1585433|NCT03572972|2915408|Superiority||Hazard Ratio (HR)|0.993|||||2-Sided|95.0|0.877|1.125||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585434|NCT03572972|2915408|Superiority||Hazard Ratio (HR)|0.966|||||2-Sided|95.0|0.848|1.1||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585435|NCT03572972|2915408|Superiority||Hazard Ratio (HR)|0.977|||||2-Sided|95.0|0.85|1.122||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585436|NCT03572972|2915409|Superiority||Hazard Ratio (HR)|0.749|||||2-Sided|95.0|0.588|0.954|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585437|NCT03572972|2915409|Superiority||Hazard Ratio (HR)|0.624|||||2-Sided|95.0|0.544|0.715||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585438|NCT03572972|2915409|Superiority||Hazard Ratio (HR)|0.64|||||2-Sided|95.0|0.556|0.738||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585439|NCT03572972|2915410|Superiority||Hazard Ratio (HR)|0.63|||||2-Sided|95.0|0.447|0.888||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585440|NCT03572972|2915410|Superiority||Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.647|1.225||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585441|NCT03572972|2915410|Superiority||Hazard Ratio (HR)|1.463|||||2-Sided|95.0|0.998|2.145||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585442|NCT03572972|2915411|Superiority||Hazard Ratio (HR)|0.747|||||2-Sided|95.0|0.548|1.018||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585443|NCT03572972|2915411|Superiority||Hazard Ratio (HR)|0.491|||||2-Sided|95.0|0.337|0.715||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585444|NCT03572972|2915411|Superiority||Hazard Ratio (HR)|0.673|||||2-Sided|95.0|0.47|0.964||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585445|NCT03572972|2915412|Superiority||Hazard Ratio (HR)|0.875|||||2-Sided|95.0|0.786|0.975||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585577|NCT03551743|2915827|Superiority||Least Squares Means (Difference)|198560.4||||0.0004|2-Sided||||||ANCOVA||||
1585446|NCT03572972|2915412|Superiority||Hazard Ratio (HR)|0.768|||||2-Sided|95.0|0.684|0.862||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585447|NCT03572972|2915412|Superiority||Hazard Ratio (HR)|0.866|||||2-Sided|95.0|0.761|0.985||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585448|NCT03572972|2915413|Superiority||Hazard Ratio (HR)|0.844|||||2-Sided|95.0|0.685|1.04|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585449|NCT03572972|2915413|Superiority||Hazard Ratio (HR)|0.754|||||2-Sided|95.0|0.597|0.953|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585450|NCT03572972|2915413|Superiority||Hazard Ratio (HR)|0.583|||||2-Sided|95.0|0.512|0.664||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585451|NCT03572972|2915414|Superiority||Hazard Ratio (HR)|0.961|||||2-Sided|95.0|0.854|1.082||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585452|NCT03572972|2915414|Superiority||Hazard Ratio (HR)|0.949|||||2-Sided|95.0|0.839|1.073||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585453|NCT03572972|2915414|Superiority||Hazard Ratio (HR)|0.993|||||2-Sided|95.0|0.87|1.134||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585454|NCT03572972|2915415|Superiority||Hazard Ratio (HR)|0.705|||||2-Sided|95.0|0.563|0.884|||||HR evaluated using extended Cox model.|Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585455|NCT03572972|2915415|Superiority||Hazard Ratio (HR)|0.604|||||2-Sided|95.0|0.53|0.687||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of HR at year 1 as an extended Cox model was used.|
1585456|NCT03572972|2915415|Superiority||Hazard Ratio (HR)|0.618|||||2-Sided|95.0|0.541|0.707||||||Cox proportional hazards model was used to compare event rates between the treatment groups. To check the proportional hazards assumption, the graphical methods and statistical tests using the time-dependent covariate were used. If there were evidence of violation in the proportional hazards assumption in graphical methods, the statistical tests were used and if the evidence of assumption violation still existed, the value of hazard ratio (HR) at year 1 as an extended Cox model was used.|
1585457|NCT03570047|2915443|Other||Hazard Ratio (HR)|1.03||||0.4404|2-Sided|95.0|0.958|1.103|||Cox proportional hazards model||||
1585458|NCT03570047|2915443|Other||Hazard Ratio (HR)|0.94||||0.064|2-Sided|95.0|0.881|1.004|||Cox proportional hazards model||||
1585459|NCT03570047|2915443|Other||Hazard Ratio (HR)|0.96||||0.2893||95.0|0.881|1.039|||Cox proportional hazards model||||
1585460|NCT03570047|2915443|Other||Hazard Ratio (HR)|0.93||||0.0127|2-Sided|95.0|0.872|0.984|||Cox proportional hazards model||||
1585461|NCT03570047|2915444|Other||Hazard Ratio (HR)|0.71||||0.0011|2-Sided|95.0|0.583|0.874|||Cox proportional hazards model||||
1585462|NCT03570047|2915444|Other||Hazard Ratio (HR)|0.74||||0.0007|2-Sided|95.0|0.618|0.879|||Cox proportional hazards model||||
1585463|NCT03570047|2915444|Other||Hazard Ratio (HR)|0.66||||0.0003|2-Sided|95.0|0.529|0.825|||Cox proportional hazards model||||
1585464|NCT03570047|2915444|Other||Hazard Ratio (HR)|0.72|||<|0.0001|2-Sided|95.0|0.614|0.843|||Cox proportional hazards model||||
1585471|NCT03569202|2915462|Other||Mean Difference (Final Values)|-1.9911||||0.764|2-Sided|95.0|-15.6117|11.6295||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline|
1585472|NCT03569202|2915464|Other||||||>|0.05||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline|
1585473|NCT03569202|2915464|Other||||||>|0.012||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline|
1585474|NCT03569202|2915464|Other||Wilcoxon Z statistic|1.044|||>|0.296|2-Sided|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline|
1585475|NCT03569202|2915465|Other|||||||0.065||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline|
1585476|NCT03569202|2915465|Other|||||||0.001||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline|
1585477|NCT03569202|2915465|Other||Wilcoxon Z statistic|0.9208||||0.357|2-Sided|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline|
1585478|NCT03569202|2915467|Other|||||||0.442||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline|
1585479|NCT03569202|2915467|Other|||||||0.043||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline|
1585480|NCT03569202|2915467|Other||Wilcoxon Z statistic|-0.5387||||0.59|2-Sided|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline|
1585481|NCT03569202|2915468|Other|||||||0.9||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline|
1585482|NCT03569202|2915468|Other|||||||0.119||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline|
1585483|NCT03569202|2915468|Other||Wilcoxon Z statistic|-0.6396||||0.522|2-Sided|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline|
1585484|NCT03569202|2915469|Other|||||||0.07||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline|
1585485|NCT03569202|2915469|Other|||||||0.014||||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Within-group change from baseline|
1585486|NCT03569202|2915469|Other||Wilcoxon Z statistic|-0.7604||||0.447|2-Sided|||||A two-sided p-value less than 0.05 was considered statistically significant.|Wilcoxon rank sum test|||Between-group comparison, change from baseline|
1585487|NCT03569202|2915470|Other||Mean Difference (Final Values)|0.05032||||0.777|2-Sided|95.0|-0.3047|0.4053||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline|
1585488|NCT03569202|2915470|Other||Mean Difference (Final Values)|0.5596||||0.0026|2-Sided|95.0|0.2046|0.9146||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline|
1585489|NCT03569202|2915470|Other||Mean Difference (Final Values)|0.5093||||0.047|2-Sided|95.0|0.007267|1.0113||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline|
1585490|NCT03569202|2915471|Other||Mean Difference (Final Values)|-2.1538||||0.2516|2-Sided|95.0|-5.8836|1.5759||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline|
1585491|NCT03569202|2915471|Other||Mean Difference (Final Values)|0.01923||||0.9918|2-Sided|95.0|-3.7105|3.749||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline|
1585492|NCT03569202|2915471|Other||Mean Difference (Final Values)|2.1731||||0.412|2-Sided|95.0|-3.1016|7.4477||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline|
1585493|NCT03569202|2915472|Other||Mean Difference (Final Values)|0.8654||||0.1134|2-Sided|95.0|-0.2132|1.944||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline|
1585494|NCT03569202|2915472|Other||Mean Difference (Final Values)|1.7115||||0.0025|2-Sided|95.0|0.633|2.7901||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline|
1585495|NCT03569202|2915472|Other||Mean Difference (Final Values)|0.8462||||0.271|2-Sided|95.0|-0.6792|2.3715||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline|
1585496|NCT03569202|2915473|Other||Mean Difference (Final Values)|-1.7692||||0.6381|2-Sided|95.0|-9.2785|5.7401||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline|
1585497|NCT03569202|2915473|Other||Mean Difference (Final Values)|-4.75||||0.2098|2-Sided|95.0|-12.2593|2.7593||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline|
1585498|NCT03569202|2915473|Other||Mean Difference (Final Values)|-2.9808||||0.575|2-Sided|95.0|-13.6005|7.639||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline|
1585499|NCT03569202|2915474|Other||Mean Difference (Final Values)|-26.5283|||<|0.0001|2-Sided|95.0|-32.6036|-20.4529||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline|
1585500|NCT03569202|2915474|Other||Mean Difference (Final Values)|-24.6445|||<|0.0001|2-Sided|95.0|-30.7199|-18.5692||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Within-group change from baseline|
1585501|NCT03569202|2915474|Superiority||Mean Difference (Final Values)|1.8837|||<|0.662|2-Sided|95.0|-6.7081|10.4756||A two-sided p-value less than 0.05 was considered statistically significant.|ANOVA|||Between-group comparison, change from baseline|
1585502|NCT03569033|2915477|Other||Difference in Least Squares Means|0.09||||0.631|2-Sided|95.0|-0.28|0.45|||ANCOVA||||
1585503|NCT03569033|2915478|Other||Difference in Least Squares Means|0.8||||0.627|2-Sided|95.0|-2.5|4.1|||ANCOVA||||
1585506|NCT03567005|2915513|Non-Inferiority|The pre-specified non-inferiority margin is 1.0. With a sample size of 48 (24 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in subjective overall vision with assumed standard deviation of 2.29 for paired differences (one-sided alpha=0.05).|LSM Difference|0.0|Standard Error of the Mean|0.15|||1-Sided|95.0|-0.3||||||||
1585507|NCT03567005|2915514|Non-Inferiority|The pre-specified non-inferiority margin is 0.05. With a sample size of 36 (18 per sequence group), there was approximately 80% power to reject the null hypothesis of inferiority in distance visual acuity with assumed standard deviation of 0.098 for paired difference (one-sided alpha=0.05).|Least Squares Mean (LSM) Difference|0.0|Standard Error of the Mean|0.008|||1-Sided|95.0||0.02|||||||
1585508|NCT03566810|2915526|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|98.08|||||2-Sided|90.0|92.37|104.14||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.|
1585509|NCT03566810|2915526|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|97.89|||||2-Sided|90.0|91.38|104.86||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.|
1585510|NCT03566810|2915528|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Median point estimate difference|0.0|||||2-Sided|90.0|-0.5|0.5||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.|
1585511|NCT03566810|2915528|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Median point estimate difference|0.0|||||2-Sided|90.0|-0.5|0.0||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.|
1585512|NCT03566810|2915529|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|96.89|||||2-Sided|90.0|89.87|104.46||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.|
1585513|NCT03566810|2915529|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|98.92|||||2-Sided|90.0|91.08|107.44||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.|
1585514|NCT03566810|2915530|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric LS Mean Percentage|99.39|||||2-Sided|90.0|93.15|106.05||||||Statistical Comparison of Test GXR Versus Reference GXR under Fed conditions.|
1585515|NCT03566810|2915530|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Ratio of Geometric Least Square(LS)Mean%|98.69|||||2-Sided|90.0|92.2|105.64||||||Statistical Comparison of Test GXR Versus Reference GXR under Fasting conditions.|
1585516|NCT03566680|2915531|Equivalence|||||||0.72|||||||t-test, 2 sided||||
1585517|NCT03566680|2915532|Equivalence|||||||0.08|||||||t-test, 2 sided||||
1585518|NCT03566680|2915533|Equivalence|||||||0.73|||||||t-test, 2 sided||||
1585519|NCT03566680|2915534|Equivalence||||||<|0.001|||||||t-test, 2 sided||||
1585520|NCT03566680|2915535|Equivalence||||||<|0.001|||||||t-test, 2 sided||||
1585521|NCT03566680|2915536|Equivalence||||||<|0.001|||||||t-test, 2 sided||||
1585522|NCT03564444|2915565|Superiority||Risk Difference (RD)|0.0|||||2-Sided|95.0|-6.7|1.9|||||||
1585523|NCT03563313|2915609|Superiority|||||||0.02|||||||Mixed Models Analysis||||
1585524|NCT03563313|2915610|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1585525|NCT03563313|2915611|Superiority|||||||0.001|||||||Mixed Models Analysis||||
1585526|NCT03563313|2915612|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1585527|NCT03563313|2915613|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1585528|NCT03563313|2915614|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1585529|NCT03563209|2915615|Other||||||<|0.001||||||p-value was adjusted for multiple comparisons. A priori threshold for statistical significance was set to 0.05/3 (0.0167)|Friedman|||Null hypothesis: no difference between dynamic components of elbow flexor spasticity (spasticity angle) in three different forearm positions. (Comparison groups were Spasticity angle in pronation, Spasticity angle in neutral position and Spasticity angle in supination)|
1585530|NCT03563183|2915625|Other|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|100.0||||||||||||||VE against the BOI due to confirmed HZ. The 95% Confidence Interval was not calculated as there were no subjects reported with a confirmed Zoster episode in the Unknown-HZ/su Group.|
1585531|NCT03563183|2915625|Other|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|85.2|||||2-Sided|95.0|62.6|100.0||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.|
1585532|NCT03563183|2915625|Other|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|92.6|||||2-Sided|95.0|86.6|98.7||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.|
1585533|NCT03563183|2915625|Other|VE against the BOI due to HZ (VE BOI ) was defined as the relative reduction in the BOI score in the vaccine group as compared with that in the placebo group and calculated as 1 - relative risk (i.e., 1- the HZ BOI score in the vaccine group divided by the HZ BOI score in the placebo group).|Vaccine Efficacy rate|98.6|||||2-Sided|95.0|97.1|100.0||||||VE against confirmed HZ BOI and 95% confidence intervals (CIs) are presented by frailty status in the mTVC.|
1585578|NCT03551743|2915827|Superiority||Least Squares Means (Difference)|151500.3||||0.0003|2-Sided||||||ANCOVA||||
1585579|NCT03551743|2915827|Superiority||Least Squares Means (Difference)|88722.37||||0.0032|2-Sided||||||ANCOVA||||
1597164|NCT02915835|2935783|Superiority|||||||0.11|||||||ANCOVA||||
1585534|NCT03563183|2915626|Other|Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|100.0||||0.069|2-Sided|95.0|14.61|100.0|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Unknown-HZ/su vs Unknown-Placebo groups.|
1585535|NCT03563183|2915626|Other|Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|90.17|||<|0.0001|2-Sided|95.0|75.36|96.65|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Frail-HZ/su vs Frail-Placebo groups.|
1585536|NCT03563183|2915626|Other|Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine group compared to placebo people.|Vaccine Efficacy rate|90.4|||<|0.0001|2-Sided|95.0|84.41|94.43|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Pre-Frail-HZ/su vs Pre-Frail-Placebo groups.|
1585537|NCT03563183|2915626|Other|Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the confimed herpes zoster for Herpes Zoster subunit vaccine Group compared to Placebo Group.|Vaccine Efficacy rate|95.81|||<|0.0001|2-Sided|95.0|91.58|98.22|||Poisson exact test|||Efficacy analysis aimed at comparing the confimed herpes zoster for Herpes Zoster incidence rate between Non-Frail-HZ/su vs Non-Frail-Placebo groups.|
1585538|NCT03559829|2915667|Other|||||||0.07|||||||paired t-test||||
1585539|NCT03559829|2915668|Other|||||||0.2|||||||paired t-test||||
1585540|NCT03559829|2915669|Other|||||||0.098|||||||paired t-test||||
1585541|NCT03559829|2915670|Other|||||||0.3|||||||paired t-test||||
1585542|NCT03559829|2915671|Other|||||||0.01|||||||paired t-test||||
1585543|NCT03559829|2915672|Other|||||||0.025|||||||paired t-test||||
1585544|NCT03559062|2915682|Other|||||||0.0546|||||||Mixed-effects model for repeated measure||||
1585545|NCT03559062|2915683|Other||||||<|0.0001|||||||Mixed-effects model for repeated measure||||
1585546|NCT03559062|2915684|Other||||||<|0.0001|||||||Mixed-effects model for repeated measure||||
1585547|NCT03558997|2915686|Superiority||Median Difference|0.84|||<|0.0001|2-Sided|95.0|0.45|1.27|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate & treatment as fixed factors. Median difference & its 95% CI estimated with Hodges-Lehmann method.||
1585548|NCT03558997|2915687|Superiority||Median Difference|-134.6|||<|0.0001|2-Sided|95.0|-205.51|-94.98|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate & treatment as fixed factors. Median difference & its 95% CI estimated with Hodges-Lehmann method.||
1585549|NCT03558997|2915688|Superiority||Median Difference|-13.325|||<|0.0001|2-Sided|95.0|-23.94|-8.36|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate & treatment as fixed factors. Median difference & its 95% CI estimated with Hodges-Lehmann method.||
1585550|NCT03558997|2915689|Superiority||Median Difference|335.3||||0.1231|2-Sided|95.0|-551.47|1746.55|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate & treatment as fixed factors. Median difference & its 95% CI estimated with Hodges-Lehmann method.||
1585551|NCT03558997|2915690|Superiority||Median Difference|0.665||||0.1449|2-Sided|95.0|-0.77|3.21|||ANCOVA||P-value was based on treatment differences of median change using rank based ANCOVA model with baseline measurement as covariate & treatment as fixed factors. Median difference & its 95% CI estimated with Hodges-Lehmann method.||
1585552|NCT03558997|2915691|Superiority||Least Square (LS) Mean Difference|-30.45||||0.0108|2-Sided|95.0|-53.874|-7.034|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs Dupilumab) of LS mean difference using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.||
1585553|NCT03558997|2915692|Superiority||Least Square (LS) Mean Difference|-0.94||||0.0414|2-Sided|95.0|-1.848|-0.037|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs Dupilumab) of LS mean difference using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.||
1585554|NCT03558997|2915693|Superiority||Least Square (LS) Mean Difference|7.25||||0.5416|2-Sided|95.0|-16.028|30.53|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab vs Placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.||
1585555|NCT03558997|2915694|Superiority||Least Square (LS) Mean Difference|0.03||||0.9559|2-Sided|95.0|-0.877|0.928|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab vs Placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.||
1585556|NCT03558997|2915695|Superiority||Least Square (LS) Mean Difference|0.3||||0.5438|2-Sided|95.0|-0.661|1.254|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs SCIT) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.||
1585580|NCT03551743|2915828|Superiority||Least Squares Means (Difference)|-46.26||||0.0002|2-Sided||||||ANCOVA||||
1585581|NCT03551743|2915828|Superiority||Least Squares Means (Difference)|-92.38||||0.0014|2-Sided||||||ANCOVA||||
1585582|NCT03551743|2915828|Superiority||Least Squares Means (Difference)|-65.02||||0.0344|2-Sided||||||ANCOVA||||
1585557|NCT03558997|2915696|Superiority||Least Square (LS) Mean Difference|4.73||||0.7185|2-Sided|95.0|-21.023|30.487|||ANCOVA|A Multiple imputation (MI) method addressed missing values in AUC (percent change from baseline) - Seeds: 16115 and 51161 with imputation size 40.|The confidence interval (CI) with p-value was based on treatment difference (Dupilumab + SCIT vs SCIT) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.||
1585558|NCT03556579|2915714|Superiority|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-15.38|Standard Error of the Mean|2.555|||2-Sided|95.0|-20.48|-10.27|||||Mean difference was calculated as Test Minus Control.||
1585559|NCT03556579|2915714|Superiority|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-30.56|Standard Error of the Mean|2.555|||2-Sided|95.0|-31.66|-25.46|||||Mean difference was calculated as Test minus Control.||
1585560|NCT03556579|2915715|Superiority|"Superiority was concluded if the lower limit of the 95% confidence interval was above 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.022|||2-Sided|95.0|0.14|0.23|||||Mean Difference was calculated as Test minus Control||
1585561|NCT03556579|2915716|Superiority|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.23|||2-Sided|95.0|-1.07|-0.15|||||Mean Difference was calculated as Test minus Control||
1585562|NCT03556579|2915717|Superiority|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Ratio|0.55|||||2-Sided|95.0|0.46|0.65|||||||
1585563|NCT03556579|2915718|Superiority|"Superiority was concluded if the lower limit of the 95% confidence interval was above 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.022|||2-Sided|95.0|0.15|0.23|||||Mean Difference was calculated as Test minus Control||
1585564|NCT03556579|2915719|Superiority|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-24.93|Standard Error of the Mean|2.173|||2-Sided|95.0|-29.24|-20.62|||||Mean difference was calculated as Test - Control||
1585565|NCT03556579|2915719|Superiority|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-8.86|Standard Error of the Mean|2.173|||2-Sided|95.0|-13.16|-4.55|||||Mean difference was calculated as Test - Control||
1585566|NCT03556579|2915720|Superiority|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-1.13|Standard Error of the Mean|0.162|||2-Sided|95.0|-1.45|-0.81|||||Mean difference was calculated as Test - Control|Without Distance Filter|
1585567|NCT03556579|2915720|Superiority|"Superiority was concluded if the upper limit of the 95% confidence interval was below 0.~No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints."|Mean Difference (Final Values)|-0.68|Standard Error of the Mean|0.162|||2-Sided|95.0|-1.01|-0.36|||||Mean difference was calculated as Test - Control|Without Distance Filter|
1585568|NCT03555890|2915781|Equivalence|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.857|||||2-Sided|90.0|0.815|0.902|||||||
1585569|NCT03555890|2915782|Equivalence|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.934|||||2-Sided|90.0|0.875|0.998|||||||
1585570|NCT03555890|2915783|Equivalence|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.978|||||2-Sided|90.0|0.958|0.998|||||||
1585571|NCT03555890|2915784|Equivalence|If the 90 percent (%) confidence interval of the geometric mean ratio (Levocetirizine ODT/ Levocetirizine IRT) was within the acceptable range of 0.80 to 1.25 then Levocetirizine ODT was to be considered bioequivalent to the Levocetirizine IRT.|Ratio of geometric mean|0.975|||||2-Sided|90.0|0.948|1.003|||||||
1585572|NCT03552549|2915794|Other||Hazard Ratio (HR)|0.71|||||2-Sided|95.0|0.28|1.77|||||Hazard ratio presented as PEG-Intron/INTRON A; HR <1 indicates treatment effect in favor of PEG-Intron.||
1585573|NCT03552536|2915813|Superiority|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. Least squares (LS) mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-0.6|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8583 and placebo at least 0.5 log10 copies/mL was 64%.||
1585574|NCT03551743|2915826|Superiority||Least Squares Means (Difference)|-49.99|||<|0.0001|2-Sided||||||ANCOVA||||
1585575|NCT03551743|2915826|Superiority||Least Squares Means (Difference)|-27.98|||<|0.386|2-Sided||||||ANCOVA||||
1585576|NCT03551743|2915826|Superiority||Least Squares Means (Difference)|-76.05|||<|0.1874|2-Sided||||||ANCOVA||||
1585584|NCT03551730|2915835|Superiority||Least Squares Means (Difference)|124993.1|||<|0.0001|2-Sided||||||ANCOVA||||
1585585|NCT03551730|2915835|Superiority||Least Squares Means (Difference)|53922.58|||<|0.1529|2-Sided||||||ANCOVA||||
1585586|NCT03551730|2915836|Superiority||Least Squares Means (Difference)|-0.23|||<|0.0001|2-Sided||||||ANCOVA||||
1585587|NCT03551730|2915836|Superiority||Least Squares Means (Difference)|-0.2|||<|0.0001|2-Sided||||||ANCOVA||||
1585588|NCT03551730|2915836|Superiority||Least Squares Means (Difference)|-0.23|||<|0.0001|2-Sided||||||ANCOVA||||
1585589|NCT03550378|2915879|Superiority||LS Mean Difference|-30.384|||<|0.001|2-Sided|90.0|-41.27|-19.498|||ANCOVA||||
1585590|NCT03550066|2915882|Non-Inferiority|The non-inferiority limit, d, is selected as the largest difference that is clinically acceptable. Here the non-inferiority limit is d=.6 (a medium to large effect size).||||||0.18||||||Threshold for statistical significance: <.05|t-test, 2 sided||||
1585591|NCT03549429|2915884|Superiority||Mean Difference (Final Values)|0.03||||0.23|2-Sided||||||t-test, 2 sided|paired|||
1585592|NCT03549429|2915885|Superiority||Percent difference|8.0||||0.03|2-Sided|95.0|1.5|14.4|||McNemar|||We compared the proportion of patients who had postoperative eyelid erythema with Tegaderm™ to those who had postop eyelid erythema with EyeGard®.|
1585593|NCT03549130|2915887|Superiority|||||||0.3487||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.|
1585594|NCT03549130|2915887|Superiority|||||||0.8285||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.|
1585595|NCT03549130|2915887|Superiority|||||||0.5591||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.|
1585596|NCT03549130|2915887|Superiority|||||||0.4741||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.|
1585597|NCT03549130|2915887|Superiority|||||||0.403||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.|
1585598|NCT03549130|2915887|Superiority|||||||0.7171||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.|
1585599|NCT03549130|2915887|Superiority|||||||0.7296||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.|
1585600|NCT03549130|2915887|Superiority|||||||0.5958||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.|
1585601|NCT03549130|2915888|Superiority|||||||0.2787||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.|
1585602|NCT03549130|2915888|Superiority|||||||0.474||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.|
1585603|NCT03549130|2915888|Superiority|||||||0.5101||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.|
1585604|NCT03549130|2915888|Superiority|||||||0.1116||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.|
1585605|NCT03549130|2915888|Superiority|||||||0.2997||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.|
1585606|NCT03549130|2915888|Superiority|||||||0.439||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.|
1585607|NCT03549130|2915888|Superiority|||||||0.4652||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.|
1585608|NCT03549130|2915888|Superiority|||||||0.8498||||||P-value are based on chi-square test|Chi-squared|||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.|
1585609|NCT03549130|2915889|Superiority||LS mean difference|-0.36||||0.1235|2-Sided|95.0|-0.83|0.1||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.|
1585610|NCT03549130|2915889|Superiority||LS mean difference|-0.01||||0.9498|2-Sided|95.0|-0.43|0.4||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.|
1585611|NCT03549130|2915889|Superiority||LS mean difference|-0.15||||0.4891|2-Sided|95.0|-0.57|0.27||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.|
1585612|NCT03549130|2915889|Superiority||LS mean difference|-0.19||||0.3034|2-Sided|95.0|-0.57|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.|
1585746|NCT03537274|2916031|Superiority||||||<|0.001|||||||Chi-squared||||
1585613|NCT03549130|2915890|Superiority||LS mean difference|-0.47||||0.0489|2-Sided|95.0|-0.94|0.0||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.|
1585614|NCT03549130|2915890|Superiority||LS mean difference|-0.55||||0.0158|2-Sided|95.0|-0.99|-0.1||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.|
1585615|NCT03549130|2915890|Superiority||LS mean difference|-0.37||||0.0743|2-Sided|95.0|-0.78|0.04||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.|
1585616|NCT03549130|2915890|Superiority||LS mean difference|-0.25||||0.2513|2-Sided|95.0|-0.68|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.|
1585617|NCT03549130|2915891|Superiority||LS mean difference|-0.81||||0.1088|2-Sided|95.0|-1.81|0.18||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for practical problems.|
1585618|NCT03549130|2915891|Superiority||LS mean difference|-0.71||||0.3325|2-Sided|95.0|-2.16|0.74||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.|
1585619|NCT03549130|2915891|Superiority||LS mean difference|-0.97||||0.2496|2-Sided|95.0|-2.64|0.69||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.|
1585620|NCT03549130|2915891|Superiority||LS mean difference|-0.47||||0.5063|2-Sided|95.0|-1.85|0.92||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.|
1585621|NCT03549130|2915892|Superiority||LS mean difference|-0.71||||0.1711|2-Sided|95.0|-1.72|0.31||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.|
1585622|NCT03549130|2915892|Superiority||LS mean difference|-1.63||||0.0345|2-Sided|95.0|-3.13|-0.12||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.|
1585623|NCT03549130|2915892|Superiority||LS mean difference|-1.8||||0.0333|2-Sided|95.0|-3.45|-0.14||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.|
1585624|NCT03549130|2915892|Superiority||Least Square (LS) mean difference|-0.77||||0.2446|2-Sided|95.0|-2.06|0.53||Between treatment p-values.|ANCOVA|Treatment,site used as factors;following variables as covariate:baseline, age,level of congestion symptoms at baseline,Berlin score,Epworth sleepiness|Difference between treatments of adjusted mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.|
1585625|NCT03549117|2915898|Superiority|||||||0.5811|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.|
1585626|NCT03549117|2915898|Superiority|||||||0.7744|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.|
1585627|NCT03549117|2915898|Superiority|||||||0.1823|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.|
1585628|NCT03549117|2915898|Superiority|||||||0.8213|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.|
1585629|NCT03549117|2915898|Superiority|||||||0.4245|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.|
1585630|NCT03549117|2915898|Superiority|||||||0.2381|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.|
1585631|NCT03549117|2915898|Superiority|||||||0.6251|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.|
1585747|NCT03537274|2916031|Superiority||||||<|0.001|||||||Chi-squared||||
1585632|NCT03549117|2915898|Superiority|||||||0.3826|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.|
1585633|NCT03549117|2915899|Superiority|||||||0.3955|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in practical problems.|
1585634|NCT03549117|2915899|Superiority|||||||0.3028|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in practical problems.|
1585635|NCT03549117|2915899|Superiority|||||||0.4141|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in symptoms on waking in AM.|
1585636|NCT03549117|2915899|Superiority|||||||0.7854|||||||Chi-squared|P-value are based on chi-square test.||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in symptoms on waking in AM.|
1585637|NCT03549117|2915899|Superiority|||||||0.9856|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep time problems.|
1585638|NCT03549117|2915899|Superiority|||||||0.4432|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep time problems.|
1585639|NCT03549117|2915899|Superiority|||||||0.2368|||||||Chi-squared|P-value are based on chi-square test.||Treatment comparison of participants showing improvement based on NRQLQ on any of the items in sleep problems.|
1585640|NCT03549117|2915899|Superiority|||||||0.9258|||||||Chi-squared|P-value are based on chi-square test||Treatment comparison of participants showing improvement based on NRQLQ on all of the items in sleep problems.|
1585641|NCT03549117|2915900|Superiority||LS mean difference|-0.06||||0.772|2-Sided|95.0|-0.47|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.|
1585642|NCT03549117|2915900|Superiority||LS mean difference|0.04||||0.8535|2-Sided|95.0|-0.39|0.47||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.|
1585643|NCT03549117|2915900|Superiority||LS mean difference|-0.06||||0.7747|2-Sided|95.0|-0.47|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.|
1585644|NCT03549117|2915900|Superiority||LS mean difference|0.03||||0.8775|2-Sided|95.0|-0.39|0.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.|
1585645|NCT03549117|2915901|Superiority||LS mean difference|-0.14||||0.4966|2-Sided|95.0|-0.54|0.26||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for time to clear nighttime drainage after waking up.|
1585646|NCT03549117|2915901|Superiority||LS mean difference|0.01||||0.9613|2-Sided|95.0|-0.38|0.4||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for congestion in sinuses.|
1585647|NCT03549117|2915901|Superiority||LS mean difference|-0.05||||0.8005|2-Sided|95.0|-0.45|0.35||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for nasal congestion or stuffy nose.|
1585648|NCT03549117|2915901|Superiority||LS mean difference|0.02||||0.9314|2-Sided|95.0|-0.38|0.42||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of Symptoms on Waking in the Morning in NRQLQ between active and placebo strip group for feel tired and unrefreshed.|
1585649|NCT03549117|2915902|Superiority||LS mean difference|-0.05||||0.8756|2-Sided|95.0|-0.87|0.75||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for practical problems.|
1585650|NCT03549117|2915902|Superiority||LS mean difference|-0.07||||0.9236|2-Sided|95.0|-1.6|1.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for symptoms on waking in the morning.|
1585651|NCT03549117|2915902|Superiority||LS mean difference|-0.86||||0.271|2-Sided|95.0|-2.41|0.68||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep time problems.|
1585652|NCT03549117|2915902|Superiority||LS mean difference|-0.18||||0.7961|2-Sided|95.0|-1.52|1.17||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.|
1585653|NCT03549117|2915903|Superiority||LS mean difference|0.15||||0.7285|2-Sided|95.0|-0.69|0.98||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Practical Problems.|
1585654|NCT03549117|2915903|Superiority||LS mean difference|-0.18||||0.7995|2-Sided|95.0|-1.61|1.25||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline; between treatment 95% CI.|Treatment comparison of NRQLQ between active and placebo strip group for Symptoms on Waking in the Morning.|
1585655|NCT03549117|2915903|Superiority||LS mean difference|-0.7||||0.369|2-Sided|95.0|-2.23|0.84||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model.|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep Time Problems.|
1585656|NCT03549117|2915903|Superiority||Least square (LS) mean difference|0.15||||0.8142|2-Sided|95.0|-1.14|1.45||Between treatment p-values.|ANCOVA|From ANCOVA model, baseline used as a covariate and site as a factor in the model|Difference between treatments of LS mean change from baseline.|Treatment comparison of NRQLQ between active and placebo strip group for Sleep problems.|
1585657|NCT03547531|2915904|Other|this data is analyzed using independent t-test|||||<|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of gingival index between groups|this data is analyzed using independent t-test
1585658|NCT03547531|2915905|Other|this data is analyzed using independent t-test|||||<|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of plaque index between groups|this data is analyzed using independent t-test
1585659|NCT03547531|2915906|Other|this data is analyzed using independent t-test|||||>|0.05|||||||t-test, 2 sided|||null hypotesis: there is no difference of mean of gingival index between groups|this data is analyzed using independent t-test
1585660|NCT03547531|2915907|Other||||||>|0.05|||||||t-test, 2 sided|independent t-test||Null hypothesis: the mean of plaque index between groups are not different|the statistical analysis used in this study is independent t-test
1585661|NCT03547154|2915908|Superiority or Other||Cox Proportional Hazard|0.859|||||2-Sided|95.0|0.429|1.721|||||Overall survival was analyzed using the log-rank statistic. The HR and 95% CI for the HR were obtained using Cox’s proportional hazards model.||
1585662|NCT03547154|2915909|Superiority or Other|||||||0.588||||||Analysis of Complete Response|Fisher Exact|Missing data considered failures|||
1585663|NCT03547154|2915910|Superiority or Other||||||>|0.999||||||Analysis of Major Response|Fisher Exact|Missing data considered failures|||
1585664|NCT03547154|2915911|Superiority or Other|||||||0.322||||||Analysis of Major Response|Fisher Exact|Missing data considered failures|||
1585665|NCT03546621|2915918|Superiority|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48|
1585666|NCT03546621|2915918|Superiority|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48|
1585667|NCT03546621|2915918|Superiority|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 48|
1585668|NCT03546621|2915918|Superiority|||||||1|||||||Bonferroni-Holm|||Week 24|
1585669|NCT03546621|2915918|Superiority|||||||1|||||||Bonferroni-Holm|||Week 24.|
1585670|NCT03546621|2915918|Superiority|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni–Holm|||"Week 24. Two-sided van Elteren tests, stratified by presence of cirrhosis, were used to test for differences compared to the control group.~Tests were performed on log-10 transformed data. Separate comparisons were made for each of the three MXB groups versus the control group, and adjusted p-values were computed using the Bonferroni–Holm method."|
1585671|NCT03546621|2915919|Superiority|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48|
1585672|NCT03546621|2915919|Superiority|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48|
1585673|NCT03546621|2915919|Superiority|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48|
1585674|NCT03546621|2915919|Superiority|||||||0.3305||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24|
1585675|NCT03546621|2915919|Superiority|||||||0.7529||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24|
1585676|NCT03546621|2915919|Superiority|||||||0.5984||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. The change from baseline to Week 24 in HBsAg was performed using van Elteren tests. Tests were performed on log-10 transformed data.~Separare comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted values were computed using the Bonferroni–Holm method."|
1585677|NCT03546621|2915920|Superiority|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48|
1585678|NCT03546621|2915920|Superiority|||||||0.9441||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48|
1585679|NCT03546621|2915920|Superiority|||||||1||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48|
1585680|NCT03546621|2915920|Superiority|||||||0.7371||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24.|
1585681|NCT03546621|2915920|Superiority|||||||0.4434||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 24|
1585682|NCT03546621|2915920|Superiority|||||||0.7416||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni–Holm|||"Week 24. Two-sided van Elteren tests, stratified by presence of cirrhosis, were used to test for differences compared to the control group.~Separate comparisons were made for each of the three MXB groups versus the control group, and adjusted p-values were computed using the Bonferroni–Holm method."|
1585683|NCT03546621|2915922|Superiority|||||||0.2388||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48|
1585748|NCT03537274|2916031|Superiority||||||<|0.128|||||||Chi-squared||||
1585684|NCT03546621|2915922|Superiority|||||||0.7157||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48|
1585685|NCT03546621|2915922|Superiority|||||||0.2388||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Boferroni-Holm|||Week 48|
1585686|NCT03546621|2915922|Superiority|||||||0.0428||||||A test is considered statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 24|
1585687|NCT03546621|2915922|Superiority|||||||0.0428||||||A test is considered statistically significant if the adjusted p-value is smaller than 0.05|Bonferroni-Holm|||Week 24|
1585688|NCT03546621|2915922|Superiority|||||||0.1642||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Week 24. The change from baseline to week 24 and week 48 in ALT levels was performed using van Elteren tests.~Fisher's exact test was used to test a null hypothesis of no difference in proportions (of patients with normal ALT values) against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computed using the Bonferroni-Holm method."|
1585689|NCT03546621|2915923|Superiority|||||||0.001||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.|
1585690|NCT03546621|2915923|Superiority|||||||0.0047||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.|
1585691|NCT03546621|2915923|Superiority|||||||0.0232||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||"Fisher's exact test was used to test a null hypothesis of no difference in proportions against a two-sided alternative hypothesis. Separate tests were performed for each of the three Myrcludex B treatment groups against the control group, at week 24 and week 48, and adjusted p-values were computered using the Bonferroni-Holm method.~This analysis, and presentation of descriptive statistics, was repeated for the subgroups of patients with normal/abnormal baseline ALT values."|
1585692|NCT03546621|2915924|Superiority|||||||0.7132||||||The threshold for statistical significance was p=0.05|Bonferroni-Holm|||Week 48. Two-sided Fisher's exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.|
1585693|NCT03546621|2915924|Superiority|||||||1||||||A test is considered as statistically significant if the adjusted p-value as smaller than 0.05|Bonferroni-Holm|||Week 48. Two-sided Fisher’s exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.|
1585694|NCT03546621|2915924|Superiority|||||||0.9818||||||A test is considered as statistically significant if the adjusted p-value is smaller than 0.05.|Bonferroni-Holm|||Week 48. Two-sided Fisher’s exact tests were used to test null hypothesis of no difference in the proportion of responders compared to the Tenofovir only group. Separate comparisons were made for each of the three Myrcludex B groups versus the control group, and the adjusted p-values were computed using the Bonferroni-Holm method.|
1585695|NCT03546621|2915925|Superiority||||||<|0.0001|||||||Bonferroni-Holm|||For each of the three Myrcludex B treatment groups, a null hypothesis of no clinically significant difference in proportion of responders compared to the control group (Tenofovir only), at week 24, were tested using the one-sided Wald test for superiority, at a one-sided overall significance level of 0.05 adjusted for multiple testing according to Bonferroni–Holm, with the superiority limit (test margin) set to 5%.|
1585696|NCT03544216|2915969|Other|||||||0.047||||||Analysis controlled for order, visit, and repeated measures|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (measured categorically as 30 to <35 years old and 35 to 40 years old, by self report)|"Post-Hoc Testing comparing CLDEQ-8 scores and the interaction between lens type and age group (denoted by lens type*age group) produced the following results:~p = 0.01 for MF*<35 age group compared to Single Vision (SV)*<35 age group p = 0.07 for MF*<35 age group compared to MF*>35 age group p > 0.05 for MF*<35 age group compared to Single Vision (SV)*>35 age group p > 0.05 for SV*<35 age group compared to SV*>35 age group p >0.05 for SV*<35 age group compared to MF*>35 age group p > 0.05 for MF*>35 age group compared to SV*>25 age group"
1585697|NCT03544216|2915969|Other|||||||0.3||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (continuous, measured in self-reported years)|
1585698|NCT03544216|2915969|Other|||||||0.7||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between magnitude in accommodative lag (measured in diopters with a 2 diopter visual target) and lens type (single vision or multifocal)|
1585699|NCT03544216|2915969|Other|||||||0.5||||||Analysis controlled for order, visit, and repeated measures.|Generalized linear model|||A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and refractive error (continuous, mean binocular spherical equivalent)|
1585700|NCT03544216|2915969|Other||||||<|0.001||||||"Results of post-hoc analyses comparing scores of each lens type to one another:~Habitual lens and multifocal contact lens: p <0.001 Habitual lens and single vision lens: p <0.001 Multifocal lens and single vision lens: p = 0.08"|Generalized linear models|||Generalized linear models (controlling for repeated measures) of crossover analyses was run to compare mean CLDEQ-8 scores with habitual, multifocal, and single vision contact lenses (controlling for order)|
1585749|NCT03537274|2916032|Superiority|||||||0.004|||||||Chi-squared||||
1585750|NCT03537274|2916032|Superiority|||||||0.005|||||||Chi-squared||||
1585701|NCT03543137|2915970|Equivalence|Bioequivalence was determined if the 90% CIs of the GMRs for Cmax fell completely within the range.|Geometric Mean Ratio|0.97|||||2-Sided|90.0|0.9|1.04|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)||
1585702|NCT03543137|2915975|Equivalence|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-inf fell completely within the range.|Geometric Mean Ratio|0.94|||||2-Sided|90.0|0.88|1.01|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)||
1585703|NCT03543137|2915976|Equivalence|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-t fell completely within the 0.80 – 1.25 range.|Geometric mean ratio|0.95|||||2-Sided|90.0|0.88|1.02|||||GMR= (Prototype mini Lozenge/ Nicorette mini Lozenge)||
1585704|NCT03541044|2915981|Equivalence|Bioequivalence was determined if the 90% CIs of the GMRs for Cmax fell completely within the 0.80 – 1.25 range.|Geometric Mean Ratio|0.89|||||2-Sided|90.0|0.82|0.98|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)||
1585705|NCT03541044|2915982|Equivalence|Bioequivalence was determined if the 90% CIs of the GMRs for AUC(0-inf) fell completely within the 0.80 – 1.25 range.|Geometric Mean Ratio|0.94|||||2-Sided|90.0|0.89|1.0|||||GMR = (Prototype mini Lozenge/Nicorette mini Lozenge)||
1585706|NCT03541044|2915983|Equivalence|Bioequivalence was determined if the 90% CIs of the GMRs for AUC0-t fell completely within the 0.80 – 1.25 range.|Geometric mean ratio|0.95|||||2-Sided|90.0|0.91|1.0|||||GMR= (Prototype mini Lozenge/ Nicorette mini Lozenge)||
1585707|NCT03538717|2916003|Superiority|||||||0.235|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585708|NCT03538717|2916004|Superiority|||||||0.184|||||||Chi-squared|||Neutrophil-to-lymphocyte ratio <=3|
1585709|NCT03538717|2916004|Superiority|||||||0.795|||||||Chi-squared|||Platelet levels >ULN|
1585710|NCT03538717|2916004|Superiority||||||>|0.999|||||||Chi-squared|||Neutrophil levels >ULN|
1585711|NCT03538717|2916004|Superiority||||||>|0.344|||||||Chi-squared|||Corrected Ca levels >10 mg/dL|
1585712|NCT03538717|2916004|Superiority||||||<|0.001|||||||Chi-squared|||Hgb levels <=LLN|
1585713|NCT03538717|2916004|Superiority||||||<|0.555|||||||Chi-squared|||LDH level >1.5*ULN|
1585714|NCT03538717|2916005|Superiority|||||||0.045|||||||Chi-squared|||Another site of metastasis|
1585715|NCT03538717|2916005|Superiority|||||||0.024|||||||Chi-squared|||Bone|
1585716|NCT03538717|2916005|Superiority|||||||0.327|||||||Chi-squared|||Pulmonary|
1585717|NCT03538717|2916005|Superiority|||||||0.026|||||||Chi-squared|||Hepatic|
1585718|NCT03538717|2916005|Superiority||||||>|0.999|||||||Fisher Exact|||CNS|
1585719|NCT03538717|2916005|Superiority||||||>|0.046|||||||Chi-squared|||Lymph nodes|
1585720|NCT03538717|2916006|Superiority|||||||0.091|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585721|NCT03538717|2916007|Superiority|||||||0.07|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585722|NCT03538717|2916008|Superiority|||||||0.074|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585723|NCT03538717|2916009|Superiority|||||||0.706|||||||Fisher Exact|||Majority component of non-clear cells|
1585724|NCT03538717|2916009|Superiority|||||||0.578|||||||Chi-squared|||Majority component of clear cells|
1585725|NCT03538717|2916009|Superiority|||||||0.596|||||||Chi-squared|||100% non-clear cells|
1585726|NCT03538717|2916009|Superiority|||||||0.446|||||||Chi-squared|||100% clear cells|
1585727|NCT03538717|2916010|Superiority|||||||0.01|||||||Fisher Exact|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585728|NCT03538717|2916011|Superiority|||||||0.419|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585729|NCT03538717|2916012|Superiority|||||||0.327|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585730|NCT03538717|2916013|Superiority|||||||0.123|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585731|NCT03538717|2916014|Superiority|||||||0.035|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585732|NCT03538717|2916015|Superiority|||||||0.265|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585733|NCT03538717|2916016|Superiority|||||||0.524|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585734|NCT03538717|2916017|Superiority|||||||0.138|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585735|NCT03538717|2916018|Superiority|||||||0.02|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585736|NCT03538717|2916019|Superiority|||||||0.228|||||||Fisher Exact|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585737|NCT03538717|2916020|Superiority|||||||0.113|||||||Chi-squared|||Statistics analysis (P value) was performed compositely for all the categories reported.|
1585738|NCT03537404|2916025|Other||Geometric Mean Ratio|-0.093|||||2-Sided|90.0|-0.354|0.168|||||AUCtau parameters were logarithmically transformed||
1585739|NCT03537404|2916026|Other||Geometric Mean Ratio|-0.148|||||2-Sided|90.0|-0.45|0.153|||||Cmax parameters were logarithmically transformed||
1585740|NCT03537404|2916027|Other||Geometric Mean Ratio|0.074|||||2-Sided|90.0|0.016|0.132|||||AUCtau parameters were logarithmically transformed||
1585741|NCT03537404|2916028|Other||Geometric Mean Ratio|0.271|||||2-Sided|90.0|0.159|0.383|||||Cmax parameters were logarithmically transformed||
1585742|NCT03537404|2916029|Other||Geometric Mean Ratio|-0.069|||||2-Sided|90.0|-0.201|0.064|||||AUCtau parameters were logarithmically transformed||
1585743|NCT03537404|2916029|Other||Geometric Mean Ratio|0.041|||||2-Sided|90.0|-0.075|0.157|||||AUCtau parameters were logarithmically transformed.||
1585744|NCT03537404|2916030|Other||Geometric Mean Ratio|-0.022|||||2-Sided|90.0|-0.22|0.175|||||Cmax parameters were logarithmically transformed||
1585745|NCT03537404|2916030|Other||Geometric Mean Ratio|0.02|||||2-Sided|90.0|-0.103|0.142|||||Cmax parameters were logarithmically transformed||
1585751|NCT03537274|2916032|Superiority|||||||0.078|||||||Chi-squared||||
1585752|NCT03536923|2916037|Other|||||||0.0001|||||||t-test, 1 sided||||
1585753|NCT03536923|2916039|Other|||||||0.0009|||||||t-test, 1 sided||||
1585754|NCT03536923|2916040|Other|||||||0.0001|||||||t-test, 1 sided||||
1585755|NCT03535974|2916042|Other||Mean Difference (Final Values)|10.57|Standard Error of the Mean|5.122||0.047|2-Sided||||||t-test, 2 sided||||
1585756|NCT03535844|2916043|Superiority|||||||0.9426||||||Independent t-test of change values|t-test, 2 sided||||
1585757|NCT03535844|2916044|Superiority|||||||0.005||||||Paired t-test between Week 0 and Week 16 endothelin-1 concentrations|t-test, 2 sided||||
1585758|NCT03535844|2916044|Superiority|||||||0.07|||||||t-test, 2 sided|Paired t-test between Week 0 and Week 16 endothelin-1 concentrations|||
1585759|NCT03535844|2916044|Superiority|||||||0.7052|||||||t-test, 2 sided|Independent t-test of change values|||
1585760|NCT03535844|2916047|Superiority|||||||0.9717|||||||t-test, 2 sided|t-test of change values|||
1585761|NCT03535844|2916048|Superiority|||||||0.9379|||||||t-test, 2 sided|Independent t-test of change values|||
1585762|NCT03535844|2916049|Superiority|||||||0.5859|||||||t-test, 2 sided|Independent t-test of change values|||
1585763|NCT03535844|2916050|Superiority|||||||0.9135|||||||t-test, 2 sided|Independent t-test of change values|||
1585764|NCT03535844|2916051|Superiority|||||||0.1487|||||||t-test, 2 sided|Independent t-test of change values|||
1585765|NCT03535844|2916052|Superiority|||||||0.4408|||||||t-test, 2 sided|Independent t-test of body fat % change values|||
1585766|NCT03535844|2916053|Superiority|||||||0.9882|||||||t-test, 2 sided|independent t-test of malondialdehyde change values|||
1585767|NCT03535844|2916054|Superiority|||||||0.916|||||||t-test, 2 sided|Independent t-test of diastolic blood pressure change values|||
1585768|NCT03535844|2916054|Superiority|||||||0.1951|||||||t-test, 2 sided|Independent t-test of systolic blood pressure change values|||
1585769|NCT03535844|2916055|Superiority|||||||0.7261|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 HDL cholesterol values|||
1585770|NCT03535844|2916055|Superiority||||||<|0.05|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 HDL cholesterol values|||
1585771|NCT03535844|2916055|Superiority||||||<|0.078|||||||t-test, 2 sided|Independent t-test of change HDL cholesterol values|||
1585772|NCT03535844|2916055|Superiority||||||<|0.2221|||||||t-test, 2 sided|Independent t-test of change LDL cholesterol values|||
1585773|NCT03535844|2916055|Superiority||||||<|0.1393|||||||t-test, 2 sided|Independent t-test of change total cholesterol values|||
1585774|NCT03535844|2916055|Superiority||||||<|0.4855|||||||t-test, 2 sided|Independent t-test of change triglyceride values|||
1585775|NCT03535844|2916056|Superiority||||||<|0.05|||||||t-test, 2 sided|Independent t-test of change values|||
1585776|NCT03535844|2916057|Superiority||||||<|0.05|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 nitric oxide values|||
1585777|NCT03535844|2916057|Superiority||||||<|0.07|||||||t-test, 2 sided|Paired t-test of Week 0 and Week 16 nitric oxide values|||
1585778|NCT03535844|2916057|Superiority||||||<|0.7162|||||||t-test, 2 sided|independent t-test of change values|||
1585779|NCT03535844|2916058|Superiority|||||||0.08|||||||t-test, 2 sided|independent t-test of change values|||
1585780|NCT03535844|2916059|Superiority|||||||0.3882|||||||t-test, 2 sided|Paired t-test of change values|||
1585781|NCT03535844|2916059|Superiority|||||||0.8203|||||||t-test, 2 sided|Paired t-test of change values|||
1585782|NCT03535844|2916059|Superiority|||||||0.67|||||||t-test, 2 sided|independent t-test of change values|||
1585783|NCT03535844|2916060|Superiority|||||||0.788|||||||t-test, 2 sided|Paired t-test of change values|||
1585784|NCT03535844|2916060|Superiority|||||||0.5672|||||||t-test, 1 sided|Paired t-test (Week 0 and Week 16)|||
1585785|NCT03535844|2916060|Superiority|||||||0.49|||||||t-test, 2 sided|independent t-test of change values|||
1585786|NCT03531905|2916147|Superiority||Difference of LS means|-16.3|Standard Error of the Mean|13.68||0.235|2-Sided|95.0|-43.3|10.7|||ANCOVA||||
1585787|NCT03531905|2916147|Superiority||Difference of LS means|0.5|Standard Error of the Mean|13.79||0.972|2-Sided|95.0|-26.8|27.7|||ANCOVA||||
1585788|NCT03531905|2916147|Superiority||Difference of LS means|-15.8|Standard Error of the Mean|13.95||0.258|2-Sided|95.0|-43.4|11.7|||ANCOVA||||
1585789|NCT03531905|2916149|Superiority||Difference of LS means|2.0|Standard Error of the Mean|4.66||0.676|2-Sided|95.0|-7.3|11.2|||ANCOVA||||
1585790|NCT03531905|2916149|Superiority||Difference of LS means|0.6|Standard Error of the Mean|4.64||0.904|2-Sided|95.0|-8.6|9.7|||ANCOVA||||
1585791|NCT03531905|2916149|Superiority||Difference of LS means|2.5|Standard Error of the Mean|4.64||0.589|2-Sided|95.0|-6.7|11.7|||ANCOVA||||
1585792|NCT03531905|2916150|Superiority||Difference of LS means|-1.1|Standard Error of the Mean|1.81||0.556|2-Sided|95.0|-4.6|2.5|||ANCOVA||||
1585793|NCT03531905|2916150|Superiority||Difference of LS means|0.8|Standard Error of the Mean|1.83||0.669|2-Sided|95.0|-2.8|4.4|||ANCOVA||||
1585794|NCT03531905|2916150|Superiority||Difference of LS means|-0.3|Standard Error of the Mean|1.83||0.877|2-Sided|95.0|-3.9|3.3|||ANCOVA||||
1585795|NCT03531905|2916152|Superiority||||||<|0.001|||||||Fisher Exact||||
1585796|NCT03531905|2916152|Superiority||||||<|0.001|||||||Fisher Exact||||
1585797|NCT03531905|2916153|Superiority||||||<|0.001|||||||Fisher Exact||||
1585798|NCT03531905|2916153|Superiority||||||<|0.118|||||||Fisher Exact||||
1585799|NCT03531905|2916153|Superiority||||||<|0.001|||||||Fisher Exact||||
1585800|NCT03531905|2916154|Superiority||Difference of LS means|1.4|Standard Error of the Mean|2.11||0.517|2-Sided|95.0|-2.8|5.5|||ANCOVA||||
1585801|NCT03531905|2916154|Superiority||Difference of LS means|-7.3|Standard Error of the Mean|2.12|<|0.001|2-Sided|95.0|-11.5|-3.1|||ANCOVA||||
1585802|NCT03531905|2916154|Superiority||Difference of LS means|-5.9|Standard Error of the Mean|2.14|<|0.007|2-Sided|95.0|-10.1|-1.7|||ANCOVA||||
1586159|NCT03465436|2917211|Superiority||LS Mean|1.21|||||2-Sided|90.0|0.09|2.34||||||4 hours postdose|
1585803|NCT03531905|2916155|Superiority||Difference of LS means|-9.2|Standard Error of the Mean|4.75||0.068|2-Sided|95.0|-17.92|0.68|||ANCOVA||||
1585804|NCT03531905|2916155|Superiority||Difference of LS means|4.7|Standard Error of the Mean|5.25||0.351|2-Sided|95.0|-4.93|15.63|||ANCOVA||||
1585805|NCT03531905|2916155|Superiority||Location shift|-3.9|Standard Error of the Mean|5.44||0.457|2-Sided|95.0|-14.55|6.79|||Wilcoxon rank sum test||||
1585806|NCT03531905|2916156|Superiority||Difference of LS means|-14.4|Standard Error of the Mean|2.68|<|0.001|2-Sided|95.0|-19.7|-9.1|||ANCOVA||||
1585807|NCT03531905|2916156|Superiority||Difference of LS means|-12.8|Standard Error of the Mean|2.71|<|0.001|2-Sided|95.0|-18.1|-7.4|||ANCOVA||||
1585808|NCT03531905|2916156|Superiority||Difference of LS means|-27.2|Standard Error of the Mean|2.73|<|0.001|2-Sided|95.0|-32.6|-21.8|||ANCOVA||||
1585809|NCT03531905|2916157|Superiority||Difference of LS means|-13.9|Standard Error of the Mean|2.21|<|0.001|2-Sided|95.0|-18.2|-9.5|||ANCOVA||||
1585810|NCT03531905|2916157|Superiority||Difference of LS means|-13.4|Standard Error of the Mean|2.24|<|0.001|2-Sided|95.0|-17.8|-9.0|||ANCOVA||||
1585811|NCT03531905|2916157|Superiority||Difference of LS means|-27.2|Standard Error of the Mean|2.25|<|0.001|2-Sided|95.0|-31.7|-22.8|||ANCOVA||||
1585812|NCT03531905|2916158|Superiority||Difference of LS means|-17.8|Standard Error of the Mean|2.76|<|0.001|2-Sided|95.0|-23.3|-12.4|||ANCOVA||||
1585813|NCT03531905|2916158|Superiority||Difference of LS means|-15.3|Standard Error of the Mean|2.8|<|0.001|2-Sided|95.0|-20.8|-9.7|||ANCOVA||||
1585814|NCT03531905|2916158|Superiority||Difference of LS means|-33.1|Standard Error of the Mean|2.81|<|0.001|2-Sided|95.0|-38.6|-27.5|||ANCOVA||||
1585815|NCT03531905|2916159|Superiority||Location shift|-7.5|Standard Error of the Mean|11.29||0.48|2-Sided|95.0|-30.51|13.76|||Wilcoxon rank sum test||||
1585816|NCT03531905|2916159|Superiority||Location shift|-29.2|Standard Error of the Mean|10.03||0.005|2-Sided|95.0|-48.92|-9.62|||Wilcoxon rank sum test||||
1585817|NCT03531905|2916159|Superiority||Location shift|-36.7|Standard Error of the Mean|9.77|<|0.001|2-Sided|95.0|-55.97|-17.67|||Wilcoxon rank sum test||||
1585818|NCT03531905|2916160|Superiority||Difference of LS means|-20.1|Standard Error of the Mean|3.08|<|0.001|2-Sided|95.0|-26.2|-14.0|||ANCOVA||||
1585819|NCT03531905|2916161|Superiority||Difference of LS means|-20.1|Standard Error of the Mean|3.08|<|0.001|2-Sided|95.0|-26.2|-14.0|||ANCOVA||||
1585820|NCT03531905|2916161|Superiority||Difference of LS means|-19.5|Standard Error of the Mean|3.11|<|0.001|2-Sided|95.0|-25.7|-13.4|||ANCOVA||||
1585821|NCT03531905|2916161|Superiority||Difference of Least Squares (LS) means|-39.6|Standard Error of the Mean|3.14|<|0.001|2-Sided|95.0|-45.8|-33.4|||ANCOVA||||
1585822|NCT03527173|2916211|Non-Inferiority|VE in reduction of shigellosis is demonstrated if lower limit (LL) of 90% CI of VE estimated with Miettinen-Nurminen (M-N) method is above 0. This estimated CI was complemented with Barnard test. The LL of the 90% CI for VE calculated with M-N method is above 0 if the p-value of the one-sided Barnard test is below 5%.|Vaccine efficacy rate|-9.4||||0.4266|2-Sided|90.0|-96.7|33.7|||1-sided Barnard Unconditional Exact Test|||To demonstrate the efficacy of two vaccinations with 25 µg of S. sonnei vaccine in healthy adults compared to placebo in preventing shigellosis, fulfilling the protocol primary case definition, after challenge with S. sonnei 53G strain. Vaccine efficacy (VE) rate was assessed as 1-Risk Ratio(RR) with RR = ratio of proportion of subjects with shigellosis in the vaccinated group on the proportion of subjects with shigellosis in the placebo group.|
1585823|NCT03525548|2916283|Superiority||LS mean difference|17.4|||<|0.0001|2-Sided|95.0|11.8|23.0|||Mixed-effects model for repeated measure||||
1585824|NCT03525548|2916284|Superiority||LS mean difference|-45.1|||<|0.0001|2-Sided|95.0|-50.1|-40.1|||Mixed-effects model for repeated measure||||
1585825|NCT03525548|2916285|Superiority||Least squares (LS) mean difference|10.0|||<|0.0001|2-Sided|95.0|7.4|12.6|||Mixed-effects model for repeated measure||||
1585826|NCT03525444|2916288|Superiority||LS Mean Difference|2.9|||||2-Sided|95.0|2.3|3.4|||||||
1585827|NCT03525444|2916289|Superiority||LS Mean Difference|0.3|||||2-Sided|95.0|0.17|0.43|||||||
1585828|NCT03525444|2916291|Superiority||LS Mean Difference|20.1|||<|0.0001|2-Sided|95.0|16.9|23.2|||Mixed-effects model for repeated measure||||
1585829|NCT03525444|2916292|Superiority||LS Mean Difference|-41.2|||<|0.0001|2-Sided|95.0|-44.0|-38.5|||Mixed-effects model for repeated measure||||
1585830|NCT03525444|2916293|Superiority||LS Mean Difference|1.04|||<|0.0001|2-Sided|95.0|0.85|1.23|||Mixed-effects model for repeated measure||||
1585831|NCT03525444|2916294|Superiority||LS Mean Difference|20.2|||<|0.0001|2-Sided|95.0|17.5|23.0|||Mixed-effects model for repeated measure||||
1585832|NCT03525444|2916295|Superiority||LS Mean Difference|-41.8|||<|0.0001|2-Sided|95.0|-44.4|-39.3|||Mixed-effects model for repeated measure||||
1585833|NCT03525444|2916296|Superiority||Rate ratio|0.37|||<|0.0001|2-Sided|95.0|0.25|0.55|||Negative binomial regression model||||
1585834|NCT03525444|2916297|Superiority||LS Mean Difference|14.3|||<|0.0001|2-Sided|95.0|12.7|15.8|||Mixed-effects model for repeated measure||||
1585835|NCT03525444|2916298|Superiority||Least Squares (LS) Mean Difference|13.8|||<|0.0001|2-Sided|95.0|12.1|15.4|||Mixed-effects model for repeated measure|||The data presented for Primary endpoint was based on interim analysis at Week 4.|
1585836|NCT03524157|2916299|Non-Inferiority|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared||||
1585837|NCT03524157|2916300|Non-Inferiority|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected||||
1585838|NCT03524157|2916301|Non-Inferiority|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected||||
1585839|NCT03524157|2916303|Non-Inferiority|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected||||
1585840|NCT03524157|2916304|Non-Inferiority|it will be considered non-inferiority if there are no differences greater than 20%||||||0.008|||||||Kruskal-Wallis||||
1585841|NCT03524157|2916305|Non-Inferiority|it will be considered non-inferiority if there are no differences greater than 20%|||||>|0.05|||||||Chi-squared, Corrected||||
1597165|NCT02915835|2935784|Superiority|||||||0.84|||||||ANCOVA||||
1585842|NCT03524157|2916307|Non-Inferiority|it will be considered non-inferiority if there are no differences greater than 20%||||||0.788|||||||Kruskal-Wallis||||
1585843|NCT03524157|2916308|Non-Inferiority|it will be considered non-inferior if there are no differences greater than 20%.||||||0.273|||||||Kruskal-Wallis||||
1585844|NCT03523988|2916309|Superiority|||||||0.37||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA||||
1585845|NCT03523988|2916309|Superiority|||||||0.31||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA||||
1585846|NCT03523988|2916309|Superiority|||||||0.53||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA||||
1585847|NCT03523988|2916310|Superiority|||||||0.69||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA||||
1585848|NCT03523988|2916310|Superiority|||||||0.82||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA||||
1585849|NCT03523988|2916310|Superiority|||||||0.65||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA||||
1585850|NCT03523988|2916311|Superiority|||||||0.41||||||P-value for pain scores among the three comparison groups while chewing paraffin wax.|ANOVA||||
1585851|NCT03523988|2916311|Superiority|||||||0.63||||||P-value for pain scores among the three comparison groups while lightly biting.|ANOVA||||
1585852|NCT03523988|2916311|Superiority|||||||0.04||||||P-value for pain scores among the three comparison groups with jaw at rest.|ANOVA||||
1585853|NCT03522506|2916315|Superiority|ANOVA model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|16.77|||<|0.001|2-Sided|95.0|11.37|22.18|||ANOVA||||
1585854|NCT03522506|2916315|Superiority|ANOVA model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.29|||<|0.409|2-Sided|95.0|-7.81|3.23|||ANOVA||||
1585855|NCT03522506|2916315|Superiority|An analysis of variance (ANOVA) model was used to evaluate the 1 hour post the end of infusion MWT. The LSM sleep latency for each treatment and the associated standard error and 95% CI were estimated from the model, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.16|||<|0.436|2-Sided|95.0|-7.68|3.36|||ANOVA||||
1585856|NCT03522506|2916316|Superiority|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|16.91|||<|0.001|2-Sided|95.0|10.77|23.06|||Linear mixed effect model||||
1585857|NCT03522506|2916316|Superiority|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|33.33|||<|0.001|2-Sided|95.0|27.08|39.58|||Linear mixed effect model||||
1585858|NCT03522506|2916316|Superiority|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|9.6|||<|0.003|2-Sided|95.0|3.35|15.85|||Linear mixed effect model||||
1585859|NCT03522506|2916317|Superiority|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|25.74|||<|0.001|2-Sided|95.0|18.33|33.14|||Linear mixed effect model||||
1585860|NCT03522506|2916317|Superiority|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|32.21|||<|0.001|2-Sided|95.0|24.68|39.73|||Linear mixed effect model||||
1585861|NCT03522506|2916317|Superiority|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|14.56|||<|0.001|2-Sided|95.0|7.04|22.08|||Linear mixed effect model||||
1585862|NCT03522506|2916318|Superiority|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|26.5|||<|0.001|2-Sided|95.0|20.24|32.75|||Linear mixed effect model||||
1585863|NCT03522506|2916318|Superiority|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|30.95|||<|0.001|2-Sided|95.0|24.59|37.31|||Linear mixed effects model||||
1585935|NCT03519516|2916425|Non-Inferiority|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.741|||||||Chi-squared, Corrected||||
1585936|NCT03519516|2916427|Non-Inferiority|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.213|||||||Chi-squared||||
1585864|NCT03522506|2916318|Superiority|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|22.94|||<|0.001|2-Sided|95.0|16.58|29.3|||Linear mixed effect model||||
1585865|NCT03522506|2916319|Superiority|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.99||||0.022|2-Sided|95.0|-1.83|-0.15|||Linear mixed effect model||||
1585866|NCT03522506|2916319|Superiority|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.14||||0.753|2-Sided|95.0|-0.99|0.72|||Linear mixed effect model||||
1585867|NCT03522506|2916319|Superiority|1.75 hours post-infusion end: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.31||||0.475|2-Sided|95.0|-0.55|1.16|||Linear mixed effect model||||
1585868|NCT03522506|2916319|Superiority|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-1.65|||<|0.001|2-Sided|95.0|-2.57|-0.72|||Linear mixed effect model||||
1585869|NCT03522506|2916319|Superiority|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.26|||<|0.001|2-Sided|95.0|-3.2|-1.32|||Linear mixed effect model||||
1585870|NCT03522506|2916319|Superiority|8.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.26|||<|0.577|2-Sided|95.0|-1.2|0.68|||Linear mixed effect model||||
1585871|NCT03522506|2916319|Superiority|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.71|||<|0.001|2-Sided|95.0|-3.62|-1.8|||Linear mixed effect model||||
1585872|NCT03522506|2916319|Superiority|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.32|||<|0.001|2-Sided|95.0|-4.24|-2.4|||Linear mixed effect model||||
1585873|NCT03522506|2916319|Superiority|6.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.71|||<|0.13|2-Sided|95.0|-1.63|0.21|||Linear mixed effect model||||
1585874|NCT03522506|2916319|Superiority|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.83|||<|0.001|2-Sided|95.0|-4.91|-2.76|||Linear mixed effect model||||
1585875|NCT03522506|2916319|Superiority|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-4.3|||<|0.001|2-Sided|95.0|-5.39|-3.21|||Linear mixed effect model||||
1585876|NCT03522506|2916319|Superiority|4.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-1.69|||<|0.003|2-Sided|95.0|-2.78|-0.6|||Linear mixed effect model||||
1585877|NCT03522506|2916319|Superiority|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.16|||<|0.001|2-Sided|95.0|-4.32|-2.01|||Linear mixed effect model||||
1585937|NCT03519516|2916428|Non-Inferiority|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.238||||||statistical analysis between groups for final visit with fluorescein|Chi-squared, Corrected||||
1585878|NCT03522506|2916319|Superiority|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-3.61|||<|0.001|2-Sided|95.0|-4.79|-2.44|||Linear mixed effect model||||
1585879|NCT03522506|2916319|Superiority|2.75 hours post-infusion start: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-2.0|||<|0.001|2-Sided|95.0|-3.18|-0.83|||Linear mixed effect model||||
1585880|NCT03522506|2916319|Superiority|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.58|||<|0.317|2-Sided|95.0|-1.74|0.57|||Linear mixed effect model||||
1585881|NCT03522506|2916319|Superiority|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.44|||<|0.455|2-Sided|95.0|-1.61|0.73|||Linear mixed effect model||||
1585882|NCT03522506|2916319|Superiority|2 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.11|||<|0.847|2-Sided|95.0|-1.06|1.29|||Linear mixed effect model||||
1585883|NCT03522506|2916319|Superiority|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.22|||<|0.605|2-Sided|95.0|-1.06|0.62|||Linear mixed effect model||||
1585884|NCT03522506|2916319|Superiority|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.29|||<|0.508|2-Sided|95.0|-1.14|0.57|||Linear mixed effect model||||
1585885|NCT03522506|2916319|Superiority|6 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.01|||<|0.984|2-Sided|95.0|-0.86|0.85|||Linear mixed effect model||||
1585886|NCT03522506|2916319|Superiority|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.18|||<|0.654|2-Sided|95.0|-0.99|0.63|||Linear mixed effect model||||
1585887|NCT03522506|2916319|Superiority|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.01|||<|0.972|2-Sided|95.0|-0.81|0.84|||Linear mixed effect model||||
1585888|NCT03522506|2916319|Superiority|10 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.29|||<|0.483|2-Sided|95.0|-0.53|1.11|||Linear mixed effect model||||
1585889|NCT03522506|2916319|Superiority|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.26|||<|0.574|2-Sided|95.0|-1.17|0.66|||Linear mixed effect model||||
1585890|NCT03522506|2916319|Superiority|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|0.24|||<|0.605|2-Sided|95.0|-0.69|1.17|||Linear mixed effect model||||
1585891|NCT03522506|2916319|Superiority|14 hours pre-infusion: A linear mixed effect models was performed for all observed KSS parameters at scheduled time points. The LSM sleepless scale for each treatment and the associated standard error and 95% CI was estimated from the model at each time point, along with the differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|-0.2|||<|0.664|2-Sided|95.0|-1.13|0.73|||Linear mixed effect model||||
1585938|NCT03519516|2916428|Non-Inferiority|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.492||||||statistical analysis between groups for final visit with green lissamine|Chi-squared||||
1586160|NCT03465436|2917211|Superiority||LS Mean|1.36|||||2-Sided|90.0|0.29|2.44||||||3.5 hours postdose|
1585892|NCT03522506|2916329|Superiority|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM Difference|19.89|||<|0.001|2-Sided|95.0|13.3|26.49|||Linear mixed effects model||||
1585893|NCT03522506|2916329|Superiority|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The LSM sleep latency for each treatment and the associated standard error and 95% CI was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|LSM difference|24.35|||<|0.001|2-Sided|95.0|17.64|31.06|||Linear mixed effect model||||
1585894|NCT03522506|2916329|Superiority|The effect of TAK-925 was evaluated with a linear mixed effects model appropriate for a 4-period crossover study. The least squares mean (LSM) sleep latency for each treatment and the associated standard error and 95% confidence interval (CI) was estimated from the model at each time, along with differences between active treatments and placebo, and associated standard errors, 95% CIs, and p-values.|Least square mean difference|20.06|||<|0.001|2-Sided|95.0|13.35|26.77|||Linear mixed effect model||||
1585895|NCT03521791|2916334|Non-Inferiority|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.626|||||||Fisher Exact||||
1585896|NCT03521791|2916335|Non-Inferiority|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.117|||||||Chi-squared, Corrected||||
1585897|NCT03521791|2916336|Non-Inferiority|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.114|||||||Fisher Exact||||
1585898|NCT03521791|2916338|Non-Inferiority|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.056|||||||t-test, 2 sided||||
1585899|NCT03521791|2916339|Non-Inferiority|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.394|||||||Fisher Exact||||
1585900|NCT03521791|2916340|Non-Inferiority|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.058|||||||Wilcoxon (Mann-Whitney)||||
1585901|NCT03521791|2916341|Non-Inferiority|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.333|||||||Chi-squared, Corrected||||
1585902|NCT03521791|2916342|Non-Inferiority|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.045|||||||Wilcoxon (Mann-Whitney)||||
1585903|NCT03521791|2916343|Non-Inferiority|it is considered not inferior if the differences between the groups do not exceed 20%.||||||0.133|||||||Chi-squared, Corrected||||
1585904|NCT03521089|2916344|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1585905|NCT03521089|2916344|Superiority|||||||0.0625|||||||Wilcoxon (Mann-Whitney)||||
1585906|NCT03521089|2916344|Superiority|||||||0.3592|||||||ANCOVA||||
1585907|NCT03521089|2916345|Superiority|||||||0.0938|||||||Wilcoxon (Mann-Whitney)||||
1585908|NCT03521089|2916345|Superiority|||||||0.0938|||||||Wilcoxon (Mann-Whitney)||||
1585909|NCT03521089|2916345|Superiority|||||||0.6951|||||||ANCOVA||||
1585910|NCT03521089|2916346|Superiority|||||||0.0156|||||||Wilcoxon (Mann-Whitney)||||
1585911|NCT03521089|2916346|Superiority|||||||0.0313|||||||Wilcoxon (Mann-Whitney)||||
1585912|NCT03521089|2916346|Superiority|||||||0.2609|||||||ANCOVA||||
1585913|NCT03521089|2916347|Superiority|||||||0.7188|||||||Wilcoxon (Mann-Whitney)||||
1585914|NCT03521089|2916347|Superiority|||||||0.1875|||||||Wilcoxon (Mann-Whitney)||||
1585915|NCT03521089|2916347|Superiority|||||||0.3069|||||||ANCOVA||||
1585916|NCT03521089|2916348|Superiority|||||||0.75|||||||Wilcoxon (Mann-Whitney)||||
1585917|NCT03521089|2916348|Superiority|||||||0.0313|||||||Wilcoxon (Mann-Whitney)||||
1585918|NCT03521089|2916348|Superiority|||||||0.0067|||||||ANCOVA||||
1585919|NCT03521089|2916349|Superiority|||||||0.25|||||||Wilcoxon (Mann-Whitney)||||
1585920|NCT03521089|2916349|Superiority|||||||0.0938|||||||Wilcoxon (Mann-Whitney)||||
1585921|NCT03521089|2916349|Superiority|||||||0.9674|||||||ANCOVA||||
1585922|NCT03521089|2916350|Superiority|||||||0.0156|||||||Wilcoxon (Mann-Whitney)||||
1585923|NCT03521089|2916350|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1585924|NCT03521089|2916350|Superiority|||||||0.0039|||||||ANCOVA||||
1585925|NCT03520348|2916359|Non-Inferiority|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.414|||||||Chi-squared, Corrected||||
1585926|NCT03520348|2916360|Non-Inferiority|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.317|||||||Chi-squared, Corrected||||
1585927|NCT03520348|2916361|Non-Inferiority|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||1|||||||Chi-squared||||
1585928|NCT03520348|2916362|Non-Inferiority|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.561|||||||Chi-squared, Corrected||||
1585929|NCT03520348|2916363|Non-Inferiority|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.667|||||||Chi-squared, Corrected||||
1585930|NCT03520348|2916365|Non-Inferiority|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.137|||||||Wilcoxon (Mann-Whitney)||||
1585931|NCT03520348|2916366|Non-Inferiority|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.839|||||||Wilcoxon (Mann-Whitney)||||
1585932|NCT03520348|2916367|Non-Inferiority|it is considered noninferiority if there are no differences in the 20% between the research drug and the reference medicine||||||0.68|||||||Wilcoxon (Mann-Whitney)||||
1585933|NCT03520348|2916368|Non-Inferiority|It is considered less than 20% of differences between groups to consider non-inferiority||||||0.285|||||||Wilcoxon (Mann-Whitney)||||
1585934|NCT03519516|2916423|Non-Inferiority|The study drug is considered non-inferior with respect to the comparator if there are no differences above twenty percent||||||0.11|||||||Wilcoxon (Mann-Whitney)||||
1585939|NCT03519516|2916429|Non-Inferiority|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.495|||||||Wilcoxon (Mann-Whitney)||||
1585940|NCT03519516|2916430|Non-Inferiority|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.694|||||||Wilcoxon (Mann-Whitney)||||
1585941|NCT03519516|2916431|Non-Inferiority|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.041|||||||Chi-squared||||
1585942|NCT03519516|2916432|Non-Inferiority|it is considered as noninferiority if there is no difference greater than twenty percent between both medications||||||0.749|||||||Wilcoxon (Mann-Whitney)||||
1585943|NCT03519204|2916448|Superiority||Median Difference|13.04|Standard Error of the Mean|2.122|<|0.0001|2-Sided|95.0|8.861|17.18||P-value was computed using Wilcoxon test with normal approximation.|Wilcoxon Rank-sum Test||The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.||
1585944|NCT03519204|2916449|Superiority||Median Difference|0.558|Standard Error of the Mean|0.109492|<|0.0001|2-Sided|95.0|0.3447|0.7739||P-value was computed using Wilcoxon test with normal approximation.|Wilcoxon Rank-sum Test||The median difference (the location shift) and its 95% CI were computed using Hodges-Lehmann estimation associated with Wilcoxon statistics.||
1585945|NCT03519204|2916451|Superiority||Responder Rate Difference|84.7|||<|0.0001|2-Sided|95.0|68.2|94.2||P-value was based on 2-sided Fisher's exact test comparing responder rate between treatment group and no-treated control group.|Fisher Exact||||
1585946|NCT03513588|2916498|Other||Least Squares Mean Difference|-33.91|||<|0.001|2-Sided|80.0|-39.78|-27.47|||ANCOVA||||
1585947|NCT03513588|2916498|Other||Least Squares Mean Difference|-24.34|||<|0.001|2-Sided|80.0|-31.28|-16.7|||ANCOVA||||
1585948|NCT03512457|2916499|Superiority|Types of lesions in the following categories: Benign nevus, seborrheic keratosis, lentigo, dermatofibroma, atypical nevus. melanoma|||||<|0.05|||||||Chi-squared|||results of skin clinical examination and biopsy of clinically suspicious moles|
1585949|NCT03512457|2916500|Superiority|Chi-square||||||0.12||||||P-value of <0.05 is the threshold for statistical significance. The hypothesis was that more women randomized to the intensive intervention would perform skin self-examination.|Chi-squared|Chi-Squared is equal to 1.58, with a P-Value of 0.12.||change from baseline to 3 months in performance of skin self-examination Parallel: response rate|
1585950|NCT03512041|2916503|Superiority|||||||0.501|||||||ANOVA||||
1585951|NCT03512041|2916504|Superiority|||||||0.169|||||||ANOVA||||
1585952|NCT03512041|2916505|Superiority|||||||0.172|||||||ANOVA||||
1585953|NCT03512028|2916506|Superiority|||||||0.844||||||Main effect of group|ANOVA||||
1585954|NCT03512028|2916506|Superiority|||||||0.001||||||Main effect of time|ANOVA||||
1585955|NCT03512028|2916506|Superiority||Mean Difference (Net)|3.2||||0.002|2-Sided|||||Interaction effect of group x time from pre- to post- intervention|ANOVA||Estimated difference between slopes|Mixed model ANOVA with group (RLIC, Sham) and time (pre-, post-, and follow-up ). The main analysis of interest is the group x time interaction from pre- to post-.|
1585956|NCT03511105|2916530|Other||Percentage change|0.1|Standard Error of the Mean|5.429|||2-Sided|95.0|-11.15|10.16|||||Percentage change on GSK2798745 relative to placebo has been presented.||
1585957|NCT03511105|2916530|Other||Absolute Difference|-0.06|Standard Error of the Mean|3.178|||2-Sided|95.0|-6.28|6.2|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI have been presented.||
1585958|NCT03511105|2916531|Other||Percentage change|7.31|Standard Error of the Mean|22.837|||2-Sided|95.0|-48.2|41.64|||||Percentage change on GSK2798745 relative to placebo has been presented.||
1585959|NCT03511105|2916531|Other||Absolute Difference|-4.26|Standard Error of the Mean|13.679|||2-Sided|95.0|-31.49|22.87|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI have been presented.||
1585960|NCT03511105|2916532|Other||Percentage change|8.73|Standard Error of the Mean|13.453|||2-Sided|95.0|-21.41|31.3|||||Percentage change on GSK2798745 relative to placebo has been presented.||
1585961|NCT03511105|2916532|Other||Absolute Difference|-30.46|Standard Error of the Mean|48.662|||2-Sided|95.0|-127.07|65.51|||||Absolute difference (GSK2798745 - Placebo) and 95% CrI has been presented.||
1585962|NCT03509948|2916539|Superiority||Geometric Least Squares Mean|91.4|||||2-Sided|90.0|87.55|95.41||||||Fed/Fasted Ratio|
1585963|NCT03509948|2916541|Superiority||Geometric Least Squares Mean|1.0|||||2-Sided|90.0|0.25|1.75||||||Fed/Fasted Ratio|
1585964|NCT03509948|2916543|Superiority||Geometric Least Squares Mean|90.89|||||2-Sided|90.0|84.99|97.2||||||Fed/Fasted Ratio|
1585965|NCT03509948|2916544|Superiority||Geometric Least Squares Mean|92.08|||||2-Sided|90.0|88.37|95.95||||||Fed/Fasted Ratio|
1585966|NCT03509948|2916545|Superiority||Geometric Least Squares Mean|79.57|||||2-Sided|90.0|66.4|95.35||||||Fed/Fasted Ratio|
1585967|NCT03508843|2916566|Superiority||||||>|0.05|||||||McNemar||||
1585968|NCT03508843|2916567|Superiority||||||<|0.001|||||||McNemar||||
1585969|NCT03508843|2916568|Superiority||||||<|0.001|||||||McNemar||||
1585970|NCT03506425|2916596|Other|||||||0.83|||||||ANOVA||||
1585971|NCT03506425|2916597|Other|||||||0.08|||||||ANOVA||||
1585972|NCT03506425|2916598|Other|||||||0.32|||||||t-test, 2 sided||||
1585973|NCT03506347|2916599|Superiority|||||||0.009|||||||ANOVA||||
1585974|NCT03506347|2916600|Superiority|||||||0.001|||||||ANOVA||||
1585975|NCT03506295|2916605|Other||Odds Ratio (OR)|0.496||||0.7878|2-Sided|95.0|0.168|1.469|||Regression, Logistic||||
1585976|NCT03502915|2916619|Equivalence|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.056|Standard Deviation|2.742||0.944|2-Sided|95.0|-1.543|1.655|||t-test, 2 sided||||
1585977|NCT03502915|2916620|Equivalence|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|-2.634|Standard Deviation|3.816||0.025|2-Sided|95.0|-4.927|-0.341|||t-test, 2 sided||||
1585978|NCT03502915|2916621|Equivalence|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.12|Standard Deviation|1.28||0.748|2-Sided|95.0|-0.629|0.869|||t-test, 2 sided||||
1585999|NCT03495856|2916762|Other|Within-group paired t-test|Mean Difference (Final Values)|-2.21|Standard Error of the Mean|1.38||0.124|2-Sided|95.0|-5.09|0.66|||t-test, 2 sided||||
1585979|NCT03502915|2916622|Equivalence|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.443|Standard Deviation|2.867||0.597|2-Sided|95.0|-1.229|2.114|||t-test, 2 sided||||
1585980|NCT03502915|2916623|Equivalence|The equivalence margin is the standard error of the estimated difference.|Mean Difference (Final Values)|0.053|Standard Deviation|2.508||0.943|2-Sided|95.0|-1.402|1.507|||t-test, 2 sided||||
1585981|NCT03501277|2916624|Equivalence|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0267||||0.308|2-Sided|90.0|0.9839|1.0714|||ANOVA||||
1585982|NCT03501277|2916624|Equivalence|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen A (test) versus Regimen B (reference).|LSM difference|1.0486||||0.066|2-Sided|90.0|1.0051|1.0939|||ANOVA||||
1585983|NCT03501277|2916624|Equivalence|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of AUC(0-72) for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0009||||0.922|2-Sided|90.0|0.9862|1.0158|||ANOVA||||
1585984|NCT03501277|2916624|Equivalence|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed AUC(0-72) with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|LSM difference|1.0157||||0.081|2-Sided|90.0|1.0009|1.0308|||ANOVA||||
1585985|NCT03501277|2916625|Equivalence|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen C (test) versus Regimen D (reference).|LSM difference|0.9257||||0.124|2-Sided|90.0|0.8523|1.0053|||ANOVA||||
1585986|NCT03501277|2916625|Equivalence|Pioglitazone: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|LSM diiference|0.9594||||0.405|2-Sided|90.0|0.8837|1.0415|||ANOVA||||
1585987|NCT03501277|2916625|Equivalence|Alogliptin: For each analyte, ANOVA was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative BA determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90% CI for the ratio of Cmax for Regimen C (test) versus Regimen D (reference).|LSM difference|1.0276||||0.326|2-Sided|90.0|0.9817|1.0757|||ANOVA||||
1585988|NCT03501277|2916625|Equivalence|Alogliptin: For each analyte, an analysis of variance (ANOVA) was performed on natural logarithm transformed Cmax with factors for sequence, the participant nested within sequence, period, and regimen. For the relative bioavailability (BA) determination, pairwise comparisons were performed to assess the relative BA of alogliptin and pioglitazone via point estimates and 90 percent (%) confidence interval (CI) for the ratio of Cmax for Regimen A (test) versus Regimen B (reference).|Least Square Mean (LSM) difference|1.0706||||0.014|2-Sided|90.0|1.023|1.1204|||ANOVA||||
1585989|NCT03496324|2916754|Equivalence|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for AUC0-t.|Geometric Least Square Mean|104.47|Standard Error of the Mean|6.0|||2-Sided|90.0|101.4|107.63|||||||
1585990|NCT03496324|2916754|Equivalence|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for AUC0-t.|Geometric Least Square Mean|101.57|Standard Error of the Mean|10.5|||2-Sided|90.0|96.28|107.16|||||||
1585991|NCT03496324|2916755|Equivalence|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% CI (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for Cmax.|Geometric Least Square Mean|111.66|Standard Error of the Mean|14.3|||2-Sided|90.0|103.84|120.07|||||||
1585992|NCT03496324|2916755|Equivalence|Bioequivalence was demonstrated between NfC® and Algifor® Junior if each 90% confidence interval (CI) (rounded to 2 decimal places) for the ratio between least square geometric means (test / reference) lay within 80% and 125% for Cmax.|Geometric Least Square Mean|94.19|Standard Error of the Mean|18.9|||2-Sided|90.0|85.81|103.38|||||||
1585993|NCT03495856|2916756|Other|Within-group paired t-test|Mean Difference (Final Values)|8.0|Standard Error of the Mean|1.96||0.001|2-Sided|95.0|3.92|12.08|||t-test, 2 sided||||
1585994|NCT03495856|2916757|Other|Within-group paired t-test|Mean Difference (Final Values)|13.27|Standard Error of the Mean|2.45|<|0.001|2-Sided|95.0|8.47|18.07|||t-test, 2 sided||||
1585995|NCT03495856|2916758|Other|Within-group paired t-test|Mean Difference (Final Values)|-4.96|Standard Error of the Mean|1.41||0.002|2-Sided|95.0|-7.88|-2.03|||t-test, 2 sided||||
1585996|NCT03495856|2916759|Other|Within-group paired t-test|Mean Difference (Final Values)|2.79|Standard Error of the Mean|1.07||0.016|2-Sided|95.0|0.58|5.01|||t-test, 2 sided||||
1585997|NCT03495856|2916760|Other|Within-group paired t-test|Mean Difference (Final Values)|-1.27|Standard Error of the Mean|0.5||0.018|2-Sided|95.0|-2.31|-0.24|||t-test, 2 sided||||
1585998|NCT03495856|2916761|Other|Within-group paired t-test|Mean Difference (Final Values)|-4.69|Standard Error of the Mean|1.26||0.001|2-Sided|95.0|-7.3|-2.07|||t-test, 2 sided||||
1597166|NCT02915835|2935785|Superiority|||||||0.31|||||||ANCOVA||||
1586000|NCT03495856|2916763|Other|Within-group paired t-test|Mean Difference (Final Values)|-3.34|Standard Error of the Mean|1.05||0.005|2-Sided|95.0|-5.53|-1.15||The a priori threshold for statistical significance was p less than or equal to 0.05.|t-test, 2 sided||||
1586001|NCT03495856|2916764|Other|Within-group paired t-test|Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.7||0.938|2-Sided|95.0|-1.39|1.5|||t-test, 2 sided||||
1586002|NCT03495856|2916765|Other|within-group paired t-test|Mean Difference (Final Values)|-3.67|Standard Error of the Mean|1.42||0.017|2-Sided|95.0|-6.63|-0.71|||t-test, 2 sided||||
1586003|NCT03495856|2916766|Other|within-group paired t-test|Mean Difference (Final Values)|-0.77|Standard Error of the Mean|0.37||0.05|2-Sided|95.0|-1.55|0.0||The a priori threshold for statistical significance was p less than or equal to 0.05. That calculated p-value in the statistical hypothesis test was equal to 0.05.|t-test, 2 sided||||
1586004|NCT03494985|2916777|Other||LS mean difference|0.6|||<|0.0001|2-Sided|95.0|0.3|0.9||p-value was adjusted using Dunnett's method for multiple comparisons.|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.||
1586005|NCT03494985|2916777|Other||LS mean difference|0.9|||<|0.0001|2-Sided|95.0|0.6|1.2||p-value was adjusted using Dunnett's method for multiple comparisons|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.||
1586006|NCT03494985|2916777|Other||Least square mean difference|0.6|||<|0.0001|2-Sided|95.0|0.4|0.9||p-value was adjusted using Dunnett's method for multiple comparisons|ANOVA|ANOVA model with factors for treatment, study site and DMI stratification (mild, moderate, severe).|First named treatment minus second named treatment such that a positive value favours the first named treatment.||
1586007|NCT03493815|2916779|Superiority|||||||0.7|||||||Fisher Exact||||
1586008|NCT03493815|2916780|Superiority|||||||0.76|||||||t-test, 2 sided||||
1586009|NCT03493815|2916781|Superiority||Risk Ratio (RR)|0.58||||0.41|2-Sided|95.0|0.15|2.18|||binary regression w/ comp log-log link||Ultrasound guided is the numerator and traditional is the denominator.||
1586010|NCT03493815|2916782|Superiority||Risk Ratio (RR)|0.73||||0.51|2-Sided|95.0|0.28|1.9|||binary regression w/ comp log-log link||Ultrasound guided is the numerator and traditional is the denominator.||
1586011|NCT03493542|2916791|Non-Inferiority|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in %|0.0|||<|0.0001|2-Sided|95.0|-1.1|1.2|||Miettinen & Nurminen method||Difference in % = (9-19 year old %) minus (20-26 year-old %)|Anti-HPV 18|
1586012|NCT03493542|2916791|Non-Inferiority|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in %|0.0|||<|0.0001|2-Sided|95.0|-1.1|1.2|||Miettinen & Nurminen method||Difference in % = (9-19 year old %) minus (20-26 year-old %)|Anti-HPV 16|
1586013|NCT03493542|2916791|Non-Inferiority|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in %|0.0|||<|0.0001|2-Sided|95.0|-1.1|1.2|||Miettinen & Nurminen method||Difference in % = (9-19 year old %) minus (20-26 year-old %)|Anti-HPV 11|
1586014|NCT03493542|2916791|Non-Inferiority|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval for the difference (9 to 19 years old minus 20 to 26 years old) in seroconversion percentages being greater than -5 percentage points for each HPV type.|Difference in percentages (%)|0.0|||<|0.0001|2-Sided|95.0|-1.1|1.2|||Miettinen & Nurminen method||Difference in % = (9-19 year old %) minus (20-26 year-old %)|Anti-HPV 6|
1586015|NCT03493542|2916796|Non-Inferiority|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.66|||<|0.0001|2-Sided|95.0|1.45|1.9|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 18|
1586016|NCT03493542|2916796|Non-Inferiority|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.53|||<|0.0001|2-Sided|95.0|1.37|1.7|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 16|
1586017|NCT03493542|2916796|Non-Inferiority|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.39|||<|0.0001|2-Sided|95.0|1.25|1.55|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 11|
1586018|NCT03493542|2916796|Non-Inferiority|The statistical criterion for non-inferiority required that the lower bound of two-sided 95% confidence interval of GMT ratio (9 to 19 years old/20 to 26 years old) was greater than 0.67 for each HPV type.|GMT Ratio|1.42|||<|0.0001|2-Sided|95.0|1.28|1.58|||ANOVA||GMT Ratio = GMT (9-19 yr)/GMT(20-26 yr)|Anti-HPV 6|
1586019|NCT03493386|2916843|Equivalence|If the 90% CI of the ratio of geometric mean doesn’t fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geomtric mean|0.89||||||90.0|0.73|1.08|||||||
1586020|NCT03493386|2916844|Equivalence|If the 90% CI of the ratio of geometric mean doesn’t fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|0.91|||||2-Sided|90.0|0.82|1.01|||||AUC (0-inf)||
1586021|NCT03493386|2916844|Equivalence|If the 90% CI of the ratio of geometric mean doesn’t fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|0.91|||||2-Sided|90.0|0.82|1.01|||||AUC (0-t)||
1586154|NCT03466060|2917200|Superiority||Posterior mean difference|-2.1|Standard Deviation|2.23|||2-Sided|95.0|-6.4|2.3|||||Posterior mean difference was calculated as Test-Control.|1-Minute Follow-up Analysis|
1586022|NCT03493386|2916851|Equivalence|If the 90% CI of the ratio of geometric mean doesn’t fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.04|||||2-Sided|90.0|0.97|1.12|||||Cmax||
1586023|NCT03493386|2916852|Equivalence|If the 90% CI of the ratio of geometric mean doesn’t fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.02|||||2-Sided|90.0|0.97|1.07|||||AUC(0-inf)||
1586024|NCT03493386|2916852|Equivalence|If the 90% CI of the ratio of geometric mean doesn’t fall within a range of 0.80 to 1.25 i.e., null hypothesis is not rejected the bioequivalence is established if the point estimate falls within a range of 0.90 to 1.11|Ratio of geometric mean|1.02|||||2-Sided|90.0|0.97|1.07|||||AUC (0-t)||
1586025|NCT03492554|2916854|Other||||||<|0.0001|||||||1 sided exact binomial|||H0: agreement proportion of R wave amplitude = 0.8 H1: agreement proportion of R wave amplitude > 0.8 Under the assumption that the true population agreement proportion of R wave amplitude was 90%, 88 subjects would provide at least 80% power to reject the null hypothesis using a one-sided type I error of 0.05. To account for obtaining readable waveforms, approximately 140 subjects (70 SR; 70 AF) were randomly selected.|
1586026|NCT03492554|2916855|Other||||||<|0.0001|||||||1 sided exact binomial|||H0: agreement proportion of visual display= 0.8 H1: agreement proportion of visual display> 0.8 Under the assumption that the true population agreement proportion of visual display was 90%, 88 subjects would provide at least 80% power to reject the null hypothesis using a one-sided type I error of 0.05. To account for obtaining readable waveforms, approximately 140 subjects (70 SR; 70 AF) were randomly selected.|
1586027|NCT03492554|2916856|Other||||||<|0.0001|||||||1 sided exact binomial test|||H0: Sensitivity = 90% H1: Sensitivity > 90% Under the assumption that the true population sensitivity is 95%, 231 subjects who were diagnosed with AF based on the 12-lead ECG reference strip and where the device algorithm classification produced a result of AF or SR was calculated to provide at least 80% power to reject the null hypothesis, using a one-sided type I error of 0.025. To obtain readable waveforms, a minimum of 260 subjects with a known diagnosis of AF were enrolled.|
1586028|NCT03492554|2916857|Other||||||<|0.0001|||||||1 sided exact binomial test|||H0: Specificity = 92% H1: Specificity > 92 Under the assumption that the true population specificity is 96.5%, 226 subjects who were diagnosed with SR based on the 12-lead ECG reference strip and where the device algorithm classification produced a result of AF or SR was calculated to provide at least 80% power to reject its null hypothesis, using a one-sided type I error of 0.025. To obtain readable waveforms approximately 300 subjects with no known diagnosis of AF were enrolled.|
1586029|NCT03491553|2916872|Other||Percentage Difference|10.0|||||2-Sided|95.0|-47.2|47.1|||||The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.||
1586030|NCT03491553|2916872|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586031|NCT03491553|2916872|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586032|NCT03491553|2916872|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586033|NCT03491553|2916873|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586034|NCT03491553|2916873|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586035|NCT03491553|2916873|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586036|NCT03491553|2916873|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586037|NCT03491553|2916874|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586038|NCT03491553|2916874|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586039|NCT03491553|2916874|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586040|NCT03491553|2916874|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586041|NCT03491553|2916875|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586042|NCT03491553|2916875|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586043|NCT03491553|2916875|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586044|NCT03491553|2916875|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586045|NCT03491553|2916876|Other||Percentage Difference|10.0|||||2-Sided|95.0|-47.2|47.1|||||The 2-sided 95% CI for the percentage difference by HBeAg status was constructed based on the standardized statistic and inverting two 1-sided tests.||
1586046|NCT03491553|2916876|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586047|NCT03491553|2916876|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586048|NCT03491553|2916876|Other||Percentage Difference|0.0|||||2-Sided|95.0|||||||||
1586049|NCT03488108|2916902|Superiority|||||||0.005|||||||Wilcoxon (Mann-Whitney)||||
1586050|NCT03488108|2916903|Superiority|||||||0.003|||||||Wilcoxon (Mann-Whitney)||||
1586051|NCT03488108|2916904|Superiority|||||||0.9|||||||Wilcoxon (Mann-Whitney)||||
1586052|NCT03488108|2916905|Superiority|||||||0.009|||||||Wilcoxon (Mann-Whitney)||||
1586053|NCT03486392|2916913|Superiority||Difference of LS Means|-5.78|Standard Error of the Mean|0.91|<|0.001|2-Sided|95.0|-7.99|-3.57|||Dunnett’s method||||
1586054|NCT03486392|2916913|Superiority||Difference of LS Means|-10.04|Standard Error of the Mean|0.934|<|0.001|2-Sided|95.0|-12.31|-7.78|||Dunnett’s method||||
1586055|NCT03486392|2916913|Superiority||Difference of LS Means|-8.07|Standard Error of the Mean|0.921|<|0.001|2-Sided|95.0|-10.31|-5.84|||Dunnett’s method||||
1586056|NCT03486392|2916913|Superiority||Difference of least square (LS) Means|-6.75|Standard Error of the Mean|1.056|<|0.001|2-Sided|95.0|-9.31|-4.19|||Dunnett’s method||||
1586057|NCT03483896|2916914|Superiority||Mean Difference (Final Values)|-6.0||||0.17|2-Sided||||||Mixed Models Analysis||||
1586058|NCT03483896|2916915|Superiority||Mean Difference (Final Values)|-3.5||||0.01|2-Sided||||||Mixed Models Analysis||||
1586059|NCT03483623|2916916|Superiority|||||||0.0001||||||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|
1586155|NCT03465436|2917211|Superiority||LS Mean|-0.12|||||2-Sided|90.0|-1.29|1.04||||||24 hours postdose|
1586156|NCT03465436|2917211|Superiority||LS Mean|0.73|||||2-Sided|90.0|-0.87|2.34||||||12 hours postdose|
1586060|NCT03483623|2916917|Superiority|||||||0.0001||||||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|
1586061|NCT03483623|2916918|Superiority|||||||0.0001||||||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|
1586062|NCT03483623|2916919|Superiority|||||||0.0001||||||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|
1586063|NCT03483623|2916920|Superiority|||||||0.0001||||||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|
1586064|NCT03483623|2916921|Superiority|||||||0.0001||||||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|
1586065|NCT03483623|2916922|Superiority|||||||0.0001||||||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|
1586066|NCT03483623|2916923|Superiority|||||||0.0001||||||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|ANOVA|||Statistical analysis applies to all combinations—NATO WELP, NATO FIS, RAVEN WELP, RAVEN FIS|
1586067|NCT03482713|2916931|Other||Difference least squares mean|0.76|||||2-Sided|95.0|-0.35|1.88|||||Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.||
1586068|NCT03482713|2916932|Other||Difference in least squares means|0.79|||||2-Sided|95.0|-0.34|1.93|||||Based on an ANCOVA model with terms for treatment, gender and the log-transformed baseline.||
1586069|NCT03482453|2916951|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9603|||||2-Sided|90.0|0.8861|1.0408|||||||
1586070|NCT03482453|2916952|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9506|||||2-Sided|90.0|0.874|1.0339|||||||
1586071|NCT03482453|2916952|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|1.0153|||||2-Sided|90.0|0.8977|1.1483|||||||
1586072|NCT03482453|2916957|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9317|||||2-Sided|90.0|0.8458|1.0263|||||||
1586073|NCT03482453|2916958|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The LS means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.9637|||||2-Sided|90.0|0.8361|1.1107|||||||
1586074|NCT03482453|2916958|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least square means (LS means) for the log-transformed parameters were exponentiated to obtain the point estimates and 90 percent (%) Confidence Intervals (CIs) of the geometric LS mean ratio on the original scale.|Geometric LS Mean Ratio|0.881|||||2-Sided|90.0|0.7108|1.0921|||||||
1586075|NCT03480425|2916976|Superiority||Mean Difference (Final Values)|0.12|Standard Deviation|4.4|<|0.05|2-Sided|95.0|-2.4|2.6|||t-test, 2 sided||||
1586076|NCT03479944|2916985|Superiority||Least Squares Mean Difference|-11.52|||||2-Sided|95.0|-15.87|-7.18|||||Least Squares Mean Difference from a Mixed Model for Repeated Measures||
1586077|NCT03479944|2916986|Superiority||Least Squares Mean Difference|1.2||||0.2602|2-Sided|95.0|-0.9|3.3|||t-test based on MMRM|MMRM: Mixed Model for Repeated Measures|Least Squares Mean Difference from a Mixed Model for Repeated Measures||
1586078|NCT03479944|2916987|Superiority||Least Squares Mean Difference|-1.505|||<|0.0001|2-Sided|95.0|-1.72|-1.289|||t-test based on MMRM|MMRM: Mixed Model for Repeated Measures|Least Squares Mean Difference from a Mixed Model for Repeated Measures||
1586079|NCT03478696|2917008|Superiority||Mean Difference (Net)|0.016|Standard Error of the Mean|0.0141||0.244|2-Sided|95.0|-0.011|0.044||The analysis was performed using mixed model repeated measures analysis, which included covariates of Baseline FEV1, geographical region, treatment, visit, visit by treatment and visit by Baseline interaction.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.||
1586080|NCT03478696|2917009|Superiority||Mean Difference (Net)|0.004|Standard Error of the Mean|0.0098||0.702|2-Sided|95.0|-0.016|0.023||Only if superiority is achieved on the primary study endpoint, then inferences can be made on weighted mean change from Baseline in FEV1 over 0-24 hours on Day 1 using p-values.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.||
1586081|NCT03478696|2917010|Superiority||Mean Difference (Net)|0.051|Standard Error of the Mean|0.0157||0.001|2-Sided|95.0|0.021|0.082||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 85 using p-values.|Mixed model repeated measures||Day 85||
1586157|NCT03465436|2917211|Superiority||LS Mean|-0.36|||||2-Sided|90.0|-1.54|0.83||||||8 hours postdose|
1586082|NCT03478696|2917010|Superiority||Mean Difference (Net)|0.054|Standard Error of the Mean|0.0144|<|0.001|2-Sided|95.0|0.026|0.083||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 84 using p-values.|Mixed model repeated measures||Day 84||
1586083|NCT03478696|2917010|Superiority||Mean Difference (Net)|0.063|Standard Error of the Mean|0.0134|<|0.001|2-Sided|95.0|0.036|0.089||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 28 using p-values.|Mixed model repeated measures||Day 28||
1586084|NCT03478696|2917010|Superiority||Mean Difference (Net)|0.026|Standard Error of the Mean|0.0122|<|0.037|2-Sided|95.0|0.002|0.049||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 2 using p-values.|Mixed model repeated measures||Day 2||
1586085|NCT03478696|2917011|Non-Inferiority|Non-inferiority was to be demonstrated, if the lower bound of the two-sided 95 percentage (%) confidence interval around the (FF/UMEC/VI versus BUD/FOR+TIO) treatment difference was above -50 milliliter.|Mean Difference (Net)|0.011|Standard Error of the Mean|0.0154|||2-Sided|95.0|-0.02|0.041|||||The primary treatment effect estimated (hypothetical effect) excluded data following intercurrent events: discontinuation of treatment, taking wrong treatment, taking prohibited medication, unblinding, noncompliance, COPD exacerbation or pneumonia.||
1586086|NCT03478683|2917012|Superiority||Mean Difference (Net)|0.013|Standard Error of the Mean|0.0138||0.335|2-Sided|95.0|-0.014|0.04||The analysis was performed using mixed model repeated measures analysis, which included covariates of Baseline FEV1, geographical region, treatment, visit, visit by treatment and visit by Baseline interaction.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.||
1586087|NCT03478683|2917013|Superiority||Mean Difference (Net)|-0.009|Standard Error of the Mean|0.011||0.415|2-Sided|95.0|-0.03|0.013||Only if superiority is achieved on the primary study endpoint, then inferences can be made on weighted mean change from Baseline in FEV1 over 0-24 hours on Day 1 using p-values.|Mixed model repeated measures||The treatment effect to be estimated was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.||
1586088|NCT03478683|2917014|Superiority||Mean Difference (Net)|0.038|Standard Error of the Mean|0.014||0.007|2-Sided|95.0|0.01|0.066||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 85 using p-values.|Mixed model repeated measures||Day 85||
1586089|NCT03478683|2917014|Superiority||Mean Difference (Net)|0.058|Standard Error of the Mean|0.0133|<|0.001|2-Sided|95.0|0.032|0.084||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 84 using p-values.|Mixed model repeated measures||Day 84||
1586090|NCT03478683|2917014|Superiority||Mean Difference (Net)|0.061|Standard Error of the Mean|0.0124|<|0.001|2-Sided|95.0|0.037|0.086||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 28 using p-values.|Mixed model repeated measures||Day 28||
1586091|NCT03478683|2917014|Superiority||Mean Difference (Net)|-0.01|Standard Error of the Mean|0.0139|<|0.481|2-Sided|95.0|-0.037|0.018||Only if superiority is achieved on the primary study endpoint, then inferences can be made on change from Baseline in trough FEV1 on Day 2 using p-values.|Mixed model repeated measures||Day 2||
1586092|NCT03478683|2917015|Non-Inferiority|Non-inferiority was to be demonstrated, if the lower bound of the two-sided 95 percentage (%) confidence interval around the (FF/UMEC/VI versus BUD/FOR+TIO) treatment difference was above -50 milliliter.|Mean Difference (Net)|0.015|Standard Error of the Mean|0.0143|||2-Sided|95.0|-0.013|0.043|||||The primary treatment effect estimated (hypothetical effect) excluded data following intercurrent events: discontinuation of treatment, taking wrong treatment, taking prohibited medication, unblinding, noncompliance, COPD exacerbation or pneumonia.||
1586093|NCT03475875|2917052|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|-1.9|Standard Error of the Mean|1.43|||2-Sided|95.0|-4.7|1.0|||||Mean difference was calculated as Test - Control|It was calculated that 80 participants randomized in a 1:1 fashion between the two sequences would have at least 90% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup’s Method (alpha=0.05).|
1586094|NCT03475875|2917053|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|-4.3|Standard Error of the Mean|1.73|||2-Sided|95.0|-7.7|-0.9|||||Mean difference was calculated as Test - Control|It was calculated that 80 participants randomized in a 1:1 fashion between the two sequences would have at least 90% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup’s Method (alpha=0.05).|
1586095|NCT03474081|2917065|Superiority||Mean Difference (Net)|0.087|Standard Error of the Mean|0.0159|<|0.001|2-Sided|95.0|0.056|0.118||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)||||
1586096|NCT03474081|2917066|Superiority||Mean Difference (Net)|0.122|Standard Error of the Mean|0.0144|<|0.001|2-Sided|95.0|0.094|0.15||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)||||
1586097|NCT03474081|2917067|Superiority||Mean Difference (Net)|0.095|Standard Error of the Mean|0.0167|<|0.001|2-Sided|95.0|0.062|0.128||The MMRM model included Baseline FEV1, visit, geographical region, and treatment as covariates and visit-by-Baseline FEV1 and visit-by-treatment interaction terms.|Mixed model repeated measures (MMRM)||||
1586098|NCT03473184|2917108|Other|p-values are from an ANOVA of the average numerical score (sum of erythema and edema) at 24 and 48 hours post irradiation (Days 3 and 4) with effects of subject and treatment, using Fisher's least significant differences.||||||0.0008|||||||ANOVA|||Non-irradiated diacerein and vehicle sites versus irradiated diacerein site, and irradiated vehicle and untreated irradiated sites versus non-irradiated diacerein site, and non-irradiated vehicle site versus irradiated vehicle site, and untreated irradiated site versus non-irradiated vehicle site.|
1586121|NCT03467971|2917174|Equivalence|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|105.4183|||||2-Sided|90.0|94.5723|117.5081||||||Statistical Analysis for Gliclazide|
1586099|NCT03473184|2917108|Other|p-values are from an ANOVA of the average numerical score (sum of erythema and edema) at 24 and 48 hours post irradiation (Days 3 and 4) with effects of subject and treatment, using Fisher's least significant differences.||||||1|||||||ANOVA|||Irradiated vehicle and untreated irradiated sites versus irradiated diacerein site, and non-irradiated vehicle site versus non-irradiated diacerein site and untreated irradiated site versus irradiated vehicle site.|
1586100|NCT03472534|2917111|Other|The p-value for the overall F-test was used to determine if the mean irritation scores were equal for all four products.|||||<|0.0001|||||||Fisher Exact||||
1586101|NCT03471871|2917116|Other||LS mean difference|0.006||||0.576|2-Sided|95.0|-0.015|0.026||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: SpO2 is <80%|
1586102|NCT03471871|2917116|Other||LSM difference|0.056||||0.518|2-Sided|95.0|-0.117|0.228||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: When SpO2 is <85%|
1586103|NCT03471871|2917116|Other||LS mean difference|0.088||||0.733|2-Sided|95.0|-0.431|0.607||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: SpO2 is <90%|
1586104|NCT03471871|2917116|Other||LS mean difference|0.002||||0.852|2-Sided|95.0|-0.019|0.023||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is <80%|
1586105|NCT03471871|2917116|Other||LS mean difference|0.067||||0.479|2-Sided|95.0|-0.124|0.258||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is <85%|
1586106|NCT03471871|2917116|Other||LS mean difference|0.312||||0.472|2-Sided|95.0|-0.558|1.181||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: SpO2 is <90%|
1586107|NCT03471871|2917117|Other||LS mean difference|0.25||||0.169|2-Sided|95.0|-0.11|0.61||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 8: Mean SpO2 during TST|
1586108|NCT03471871|2917117|Other||LS mean difference|0.07||||0.699|2-Sided|95.0|-0.31|0.46||P-Value was at the 0.05 level of significance.|mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||Day 1: Mean SpO2 during TST|
1586109|NCT03471871|2917119|Other||LS mean difference|0.002||||0.166|2-Sided|95.0|-0.001|0.006||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is <80%|
1586110|NCT03471871|2917119|Other||LS mean difference|0.001||||0.462|2-Sided|95.0|-0.002|0.005||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is <80%|
1586111|NCT03471871|2917119|Other||LS mean difference|0.044||||0.158|2-Sided|95.0|-0.018|0.107||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is <85%|
1586112|NCT03471871|2917119|Other||LS mean difference|0.004||||0.885|2-Sided|95.0|-0.058|0.067||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is <85%|
1586113|NCT03471871|2917119|Other||LS mean difference|0.245||||0.03|2-Sided|95.0|0.025|0.464||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||When SpO2 is <90%|
1586114|NCT03471871|2917119|Other||LS mean difference|0.185||||0.095|2-Sided|95.0|-0.034|0.405||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.||SpO2 is <90%|
1586115|NCT03471871|2917120|Other||LS mean difference|-0.03||||0.979|2-Sided|95.0|-2.22|2.17||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.|||
1586116|NCT03471871|2917121|Other||LS mean difference|-1.16||||0.297|2-Sided|95.0|-3.4|1.08||P-Value was at the 0.05 level of significance.|mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.|||
1586117|NCT03471871|2917121|Other||LS mean difference|0.52||||0.639|2-Sided|95.0|-1.72|2.76||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.|||
1586118|NCT03471871|2917122|Other||LS mean difference|-0.06||||0.948|2-Sided|95.0|-1.95|1.83||P-Value was at the 0.05 level of significance.|Mixed effect model|AHI was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.|||
1586119|NCT03471871|2917123|Other||LS mean difference|-0.29||||0.176|2-Sided|95.0|-0.72|0.14||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.|||
1586120|NCT03471871|2917123|Other||Least squares (LS) mean difference|-0.36||||0.099|2-Sided|95.0|-0.78|0.07||P-Value was at the 0.05 level of significance.|Mixed effect model|SPO2 was analyzed by mixed effect model, which included fixed effects for sequence, period, treatment a random effect for participant within sequence.|||
1586122|NCT03467971|2917174|Equivalence|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|127.7779|||||2-Sided|90.0|110.2732|148.0612||||||Statistical Analysis for Metformin|
1586123|NCT03467971|2917175|Equivalence|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|105.0818|||||2-Sided|90.0|98.0047|112.6699||||||Statistical Analysis for Gliclazide|
1586124|NCT03467971|2917175|Equivalence|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|180.7734|||||2-Sided|90.0|157.0135|208.1287||||||Statistical Analysis for Metformin|
1586125|NCT03467971|2917176|Equivalence|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|104.457|||||2-Sided|90.0|97.766|111.606||||||Statistical Analysis for Gliclazide|
1586126|NCT03467971|2917176|Equivalence|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.0% - 125.0%.|Ratio of mean values|175.6652|||||2-Sided|90.0|153.779|200.6664||||||Statistical Analysis for Metformin|
1586127|NCT03467945|2917186|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|96.1619|||||2-Sided|90.0|92.1443|100.3546|||||||
1586128|NCT03467945|2917186|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|105.915|||||2-Sided|90.0|101.49|110.533|||||||
1586129|NCT03467945|2917186|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|101.8499|||||2-Sided|90.0|97.5947|106.2906|||||||
1586130|NCT03467945|2917187|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.0112|||||2-Sided|90.0|74.8823|87.6417|||||||
1586131|NCT03467945|2917187|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|101.8499|||||2-Sided|90.0|97.8819|106.9028|||||||
1586132|NCT03467945|2917187|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|82.6022|||||2-Sided|90.0|76.5513|89.1314|||||||
1586133|NCT03467945|2917188|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|115.37|||||2-Sided|90.0|109.131|121.9658|||||||
1586134|NCT03467945|2917188|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|93.6828|||||2-Sided|90.0|88.6166|99.0386|||||||
1586135|NCT03467945|2917188|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|108.0819|||||2-Sided|90.0|102.237|114.2609|||||||
1586136|NCT03467945|2917189|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|79.4367|||||2-Sided|90.0|71.9633|87.6861|||||||
1586137|NCT03467945|2917189|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|108.0819|||||2-Sided|90.0|102.237|114.2609|||||||
1586138|NCT03467945|2917189|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|77.6923|||||2-Sided|90.0|70.383|85.7606|||||||
1586139|NCT03467945|2917190|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|96.7533|||||2-Sided|90.0|92.5812|101.1135|||||||
1586140|NCT03467945|2917190|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|105.7255|||||2-Sided|90.0|101.1665|110.49|||||||
1586141|NCT03467945|2917190|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|102.293|||||2-Sided|90.0|97.8819|106.9028|||||||
1586142|NCT03467945|2917191|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.0112|||||2-Sided|90.0|74.8823|87.6417|||||||
1586143|NCT03467945|2917191|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|102.293|||||2-Sided|90.0|97.8819|106.9028|||||||
1586144|NCT03467945|2917191|Equivalence|Bioequivalence boundaries of 80.000% to 125.00% were used.|Geometric Least Squares Mean Ratio|81.4421|||||2-Sided|90.0|75.2805|88.1079|||||||
1586145|NCT03466086|2917193|Superiority|Superiority will be declared if the lower bound of the 2-sided 95% credible interval of the difference between Test and Control is less than 0.|Mean Difference (Final Values)|1.49|Standard Deviation|0.951|||2-Sided|95.0|-0.4|3.37||||||This was a pilot study and the sample size was not based on any empirical power calculation.|Mean difference was calculated as Test - Control
1586146|NCT03466086|2917194|Superiority|This was a pilot study and the sample size was not based on any empirical power calculation.|Mean Difference (Final Values)|0.13|Standard Deviation|1.238|||2-Sided|95.0|-2.35|2.59|||||Mean Difference was calculated as Test minus Control.||
1586147|NCT03466060|2917200|Superiority||Posterior Mean Difference|-1.5|Standard Deviation|2.1|||2-Sided|95.0|-5.8|2.5|||||Posterior mean difference was calculated as Test-Control.|2-Hour Follow-up Analysis|
1586148|NCT03466060|2917200|Non-Inferiority|95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Posterior Mean Difference|-2.0|Standard Deviation|2.16|||2-Sided|95.0|-6.4|2.3|||||Posterior mean difference was calculated as Test-Control.|45-Minute Follow-up Analysis|
1586149|NCT03466060|2917200|Superiority|95% credible intervals are used to determine whether Test and Control solutions are statistically significantly different at each time point.|Posterior Mean Difference|-0.7|Standard Deviation|2.2|||2-Sided|95.0|-5.0|3.6|||||Posterior mean difference was calculated as Test-Control.|5-Minute Follow-up Analysis|
1586150|NCT03466060|2917200|Superiority||Posterior Mean Difference|-1.1|Standard Deviation|2.28|||2-Sided|95.0|-5.8|3.1|||||Posterior mean difference was calculated as Test-Control.|1-Minute Follow-up Analysis|
1586151|NCT03466060|2917200|Superiority||Posterior Mean Difference|-2.5|Standard Deviation|2.01|||2-Sided|95.0|-6.5|1.4|||||Posterior mean difference was calculated as Test-Control.|2-Hour Follow-up Analysis|
1586152|NCT03466060|2917200|Superiority||Posterior Mean Difference|-2.7|Standard Deviation|2.1|||2-Sided|95.0|-6.9|1.5|||||Posterior mean difference was calculated as Test-Control.|45-Minute Follolw-up Analysis|
1586153|NCT03466060|2917200|Superiority||Posertior Mean Difference|-2.5|Standard Deviation|2.16|||2-Sided|95.0|-6.8|1.7|||||Posterior mean difference was calculated as Test-Control.|5-minute Follow-up Analysis|
1586158|NCT03465436|2917211|Superiority||LS Mean|-0.49|||||2-Sided|90.0|-1.97|0.99||||||6 hours postdose|
1597167|NCT02915835|2935786|Superiority|||||||0.41|||||||ANCOVA||||
1586161|NCT03465436|2917211|Superiority||LS Mean|0.53|||||2-Sided|90.0|-0.5|1.56||||||3 hours postdose|
1586162|NCT03465436|2917211|Superiority||LS Mean|0.21|||||2-Sided|90.0|-0.81|1.23||||||2.5 hours postdose|
1586163|NCT03465436|2917211|Superiority||LS Mean|1.07|||||2-Sided|90.0|0.17|1.97||||||2 hours postdose|
1586164|NCT03465436|2917211|Superiority||LS Mean|1.3|||||2-Sided|90.0|0.31|2.28||||||1.5 hours postdose|
1586165|NCT03465436|2917211|Superiority||LS Mean|2.29|||||2-Sided|90.0|1.19|3.4||||||1 hour postdose|
1586166|NCT03465436|2917211|Superiority||LS Mean|1.32|||||2-Sided|90.0|0.32|2.33||||||30 minutes postdose|
1586167|NCT03465436|2917211|Superiority||LS Mean|-0.55|||||2-Sided|90.0|-1.74|0.63||||||24 hours postdose|
1586168|NCT03465436|2917211|Superiority||LS Mean|-4.71|||||2-Sided|90.0|-6.25|-3.17||||||12 hours postdose|
1586169|NCT03465436|2917211|Superiority||LS Mean|-5.37|||||2-Sided|90.0|-6.73|-4.02||||||8 hours postdose|
1586170|NCT03465436|2917211|Superiority||LS Mean|-6.29|||||2-Sided|90.0|-7.83|-4.95||||||6 hours postdose|
1586171|NCT03465436|2917211|Superiority||LS Mean|-3.19|||||2-Sided|90.0|-4.21|-2.17||||||4 hours postdose|
1586172|NCT03465436|2917211|Superiority||LS Mean|-3.69|||||2-Sided|90.0|-4.68|-2.71||||||3.5 hours postdose|
1586173|NCT03465436|2917211|Superiority||LS Mean|-4.99|||||2-Sided|90.0|-6.03|-3.96||||||3 hours postdose|
1586174|NCT03465436|2917211|Superiority||LS Mean|-5.82|||||2-Sided|90.0|-6.77|-4.87||||||2.5 hours postdose|
1586175|NCT03465436|2917211|Superiority||LS Mean|-4.64|||||2-Sided|90.0|-5.55|-3.72||||||2 hours postdose|
1586176|NCT03465436|2917211|Superiority||LS Mean|-5.39|||||2-Sided|90.0|-6.42|-4.35||||||1.5 hours postdose|
1586177|NCT03465436|2917211|Superiority||LS Mean|-5.61|||||2-Sided|90.0|-6.65|-4.58||||||1 hour postdose|
1586178|NCT03465436|2917211|Superiority||LS Mean|-3.09|||||2-Sided|90.0|-4.16|-2.02||||||30 minutes postdose|
1586179|NCT03465436|2917211|Superiority||LS Mean|0.12|||||2-Sided|90.0|-1.22|1.46||||||24 hours postdose|
1586180|NCT03465436|2917211|Superiority||LS Mean|-2.65|||||2-Sided|90.0|-4.33|-0.97||||||12 hours postdose|
1586181|NCT03465436|2917211|Superiority||LS Mean|-3.82|||||2-Sided|90.0|-5.38|-2.26||||||8 hours postdose|
1586182|NCT03465436|2917211|Superiority||LS Mean|-4.61|||||2-Sided|90.0|-6.17|-3.06||||||6 hours postdose|
1586183|NCT03465436|2917211|Superiority||LS Mean|-2.42|||||2-Sided|90.0|-3.42|-1.42||||||4 hours postdose|
1586184|NCT03465436|2917211|Superiority||LS Mean|-2.94|||||2-Sided|90.0|-3.87|-2.01||||||3.5 hours postdose|
1586185|NCT03465436|2917211|Superiority||LS Mean|-4.14|||||2-Sided|90.0|-5.2|-3.08||||||3 hours postdose|
1586186|NCT03465436|2917211|Superiority||LS Mean|-4.78|||||2-Sided|90.0|-5.91|-3.65||||||2.5 hours postdose|
1586187|NCT03465436|2917211|Superiority||LS Mean|-4.01|||||2-Sided|90.0|-5.0|-3.01||||||2 hours postdose|
1586188|NCT03465436|2917211|Superiority||LS Mean|-5.57|||||2-Sided|90.0|-6.81|-4.32||||||1.5 hours postdose|
1586189|NCT03465436|2917211|Superiority||LS Mean|-5.09|||||2-Sided|90.0|-6.29|-3.88||||||1 hour postdose|
1586190|NCT03465436|2917211|Superiority||LS Mean|-1.53|||||2-Sided|90.0|-2.9|-0.16||||||30 minutes postdose|
1586191|NCT03465436|2917212|Superiority||LS Mean|0.19|||||2-Sided|90.0|-0.23|0.61||||||24 hours postdose|
1586192|NCT03465436|2917212|Superiority||LS Mean|-0.31|||||2-Sided|90.0|-0.7|0.09||||||12 hours postdose|
1586193|NCT03465436|2917212|Superiority||LS Mean|-0.39|||||2-Sided|90.0|-0.82|0.04||||||8 hours postdose|
1586194|NCT03465436|2917212|Superiority||LS Mean|-0.6|||||2-Sided|90.0|-1.03|-0.17||||||6 hours postdose|
1586195|NCT03465436|2917212|Superiority||LS Mean|-0.38|||||2-Sided|90.0|-0.73|-0.03||||||4 hours postdose|
1586196|NCT03465436|2917212|Superiority||LS Mean|-0.39|||||2-Sided|90.0|-0.76|-0.03||||||3.5 hours postdose|
1586197|NCT03465436|2917212|Superiority||LS Mean|-0.09|||||2-Sided|90.0|-0.44|0.25||||||3 hours postdose|
1586198|NCT03465436|2917212|Superiority||LS Mean|0.02|||||2-Sided|90.0|-0.34|0.37||||||2.5 hours postdose|
1586199|NCT03465436|2917212|Superiority||LS Mean|0.01|||||2-Sided|90.0|-0.38|0.4||||||2 hours postdose|
1586200|NCT03465436|2917212|Superiority||LS Mean|0.25|||||2-Sided|90.0|-0.1|0.6||||||1.5 hours postdose|
1586201|NCT03465436|2917212|Superiority||LS Mean|-0.1|||||2-Sided|90.0|-0.46|0.27||||||1 hour postdose|
1586202|NCT03465436|2917212|Superiority||LS Mean|-0.09|||||2-Sided|90.0|-0.45|0.28||||||30 minutes postdose|
1586203|NCT03465436|2917212|Superiority||LS Mean|0.04|||||2-Sided|90.0|-0.37|0.45||||||24 hours postdose|
1586204|NCT03465436|2917212|Superiority||LS Mean|-0.39|||||2-Sided|90.0|-0.84|0.06||||||12 hours postdose|
1586205|NCT03465436|2917212|Superiority||LS Mean|-0.11|||||2-Sided|90.0|-0.56|0.33||||||8 hours postdose|
1586206|NCT03465436|2917212|Superiority||LS Mean|-0.1|||||2-Sided|90.0|-0.56|0.36||||||6 hours postdose|
1586207|NCT03465436|2917212|Superiority||LS Mean|0.5|||||2-Sided|90.0|0.16|0.84||||||4 hours postdose|
1586208|NCT03465436|2917212|Superiority||LS Mean|0.32|||||2-Sided|90.0|-0.02|0.67||||||3.5 hours postdose|
1586209|NCT03465436|2917212|Superiority||LS Mean|0.33|||||2-Sided|90.0|-0.05|0.71||||||3 hours postdose|
1586210|NCT03465436|2917212|Superiority||LS Mean|0.51|||||2-Sided|90.0|0.13|0.88||||||2.5 hours postdose|
1586211|NCT03465436|2917212|Superiority||LS Mean|0.4|||||2-Sided|90.0|0.02|0.77||||||2 hours postdose|
1586212|NCT03465436|2917212|Superiority||LS Mean|0.56|||||2-Sided|90.0|0.19|0.93||||||1.5 hours postdose|
1586213|NCT03465436|2917212|Superiority||LS Mean|0.48|||||2-Sided|90.0|0.06|0.89||||||1 hour postdose|
1586214|NCT03465436|2917212|Superiority||LS Mean|-0.19|||||2-Sided|90.0|-0.59|0.21||||||30 minutes postdose|
1586215|NCT03465436|2917212|Superiority||LS Mean|0.43|||||2-Sided|90.0|0.01|0.84||||||24 hours postdose|
1586216|NCT03465436|2917212|Superiority||LS Mean|-0.29|||||2-Sided|90.0|-0.7|0.12||||||12 hours postdose|
1586217|NCT03465436|2917212|Superiority||LS Mean|-0.14|||||2-Sided|90.0|-0.58|0.31||||||8 hours postdose|
1586218|NCT03465436|2917212|Superiority||LS Mean|-0.54|||||2-Sided|90.0|-0.98|-0.09||||||6 hours postdose|
1586219|NCT03465436|2917212|Superiority||LS Mean|-0.35|||||2-Sided|90.0|-0.66|-0.04||||||4 hours postdose|
1586220|NCT03465436|2917212|Superiority||LS Mean|-0.41|||||2-Sided|90.0|-0.72|-0.1||||||3.5 hours postdose|
1586221|NCT03465436|2917212|Superiority||LS Mean|-0.38|||||2-Sided|90.0|-0.77|0.0||||||3 hours postdose|
1586222|NCT03465436|2917212|Superiority||LS Mean|-0.55|||||2-Sided|90.0|-0.95|-0.15||||||2.5 hours postdose|
1586223|NCT03465436|2917212|Superiority||LS Mean|-0.44|||||2-Sided|90.0|-0.81|-0.07||||||2 hours postdose|
1586224|NCT03465436|2917212|Superiority||LS Mean|-0.12|||||2-Sided|90.0|-0.47|0.23||||||1.5 hours postdose|
1586225|NCT03465436|2917212|Superiority||LS Mean|-0.23|||||2-Sided|90.0|-0.61|0.15||||||1 hour postdose|
1586226|NCT03465436|2917212|Superiority||LS Mean|0.02|||||2-Sided|90.0|-0.37|0.41||||||30 minutes postdose|
1586227|NCT03465436|2917213|Superiority||LS Mean|-0.31|||||2-Sided|90.0|-17.32|16.69||||||24 hours postdose|
1586228|NCT03465436|2917213|Superiority||LS Mean|-11.95|||||2-Sided|90.0|-33.46|9.56||||||12 hours postdose|
1586229|NCT03465436|2917213|Superiority||LS Mean|2.27|||||2-Sided|90.0|-15.25|19.8||||||8 hours postdose|
1586230|NCT03465436|2917213|Superiority||LS Mean|6.13|||||2-Sided|90.0|-10.86|23.11||||||6 hours postdose|
1586231|NCT03465436|2917213|Superiority||LS Mean|-15.29|||||2-Sided|90.0|-32.94|2.37||||||4 hours postdose|
1586232|NCT03465436|2917213|Superiority||LS Mean|-16.56|||||2-Sided|90.0|-33.36|0.24||||||3.5 hours postdose|
1586233|NCT03465436|2917213|Superiority||LS Mean|-4.77|||||2-Sided|90.0|-21.81|12.27||||||3 hours postdose|
1586234|NCT03465436|2917213|Superiority||LS Mean|-1.03|||||2-Sided|90.0|-18.17|16.12||||||2.5 hours postdose|
1586235|NCT03465436|2917213|Superiority||LS Mean|-17.35|||||2-Sided|90.0|-32.15|-2.56||||||2 hours postdose|
1586236|NCT03465436|2917213|Superiority||LS Mean|-22.13|||||2-Sided|90.0|-39.35|-4.91||||||1.5 hours postdose|
1586237|NCT03465436|2917213|Superiority||LS Mean|-38.87|||||2-Sided|90.0|-57.15|-20.6||||||1 hour postdose|
1586238|NCT03465436|2917213|Superiority||LS Mean|-22.02|||||2-Sided|90.0|-38.44|-5.6||||||30 minutes postdose|
1586239|NCT03465436|2917213|Superiority||LS Mean|7.77|||||2-Sided|90.0|-10.01|25.55||||||24 hours postdose|
1586240|NCT03465436|2917213|Superiority||LS Mean|67.58|||||2-Sided|90.0|44.64|90.51||||||12 hours postdose|
1586241|NCT03465436|2917213|Superiority||LS Mean|80.12|||||2-Sided|90.0|58.32|101.91||||||8 hours postdose|
1586242|NCT03465436|2917213|Superiority||LS Mean|86.09|||||2-Sided|90.0|66.36|105.82||||||6 hours postdose|
1586243|NCT03465436|2917213|Superiority||LS Mean|52.85|||||2-Sided|90.0|36.1|69.6||||||4 hours postdose|
1586244|NCT03465436|2917213|Superiority||LS Mean|65.29|||||2-Sided|90.0|48.28|82.3||||||3.5 hours postdose|
1586245|NCT03465436|2917213|Superiority||LS Mean|89.26|||||2-Sided|90.0|71.24|107.29||||||3 hours postdose|
1586246|NCT03465436|2917213|Superiority||LS Mean|103.64|||||2-Sided|90.0|87.28|120.0||||||2.5 hours postdose|
1586247|NCT03465436|2917213|Superiority||LS Mean|83.49|||||2-Sided|90.0|67.98|99.0||||||2 hours postdose|
1586248|NCT03465436|2917213|Superiority||LS Mean|94.21|||||2-Sided|90.0|75.15|113.26||||||1.5 hours postdose|
1586249|NCT03465436|2917213|Superiority||LS Mean|103.3|||||2-Sided|90.0|83.88|122.72||||||1 hour postdose|
1586250|NCT03465436|2917213|Superiority||LS Mean|56.53|||||2-Sided|90.0|36.72|76.35||||||30 minutes postdose|
1586251|NCT03465436|2917213|Superiority||LS Mean|-4.59|||||2-Sided|90.0|-24.66|15.47||||||24 hours postdose|
1586252|NCT03465436|2917213|Superiority||LS Mean|35.71|||||2-Sided|90.0|11.79|59.63||||||12 hours postdose|
1586253|NCT03465436|2917213|Superiority||LS Mean|56.05|||||2-Sided|90.0|32.49|79.61||||||8 hours postdose|
1586254|NCT03465436|2917213|Superiority||LS Mean|62.61|||||2-Sided|90.0|42.39|82.83||||||6 hours postdose|
1586255|NCT03465436|2917213|Superiority||LS Mean|42.1|||||2-Sided|90.0|24.86|59.35||||||4 hours postdose|
1586256|NCT03465436|2917213|Superiority||LS Mean|52.83|||||2-Sided|90.0|36.03|69.63||||||3.5 hours postdose|
1586257|NCT03465436|2917213|Superiority||LS Mean|74.98|||||2-Sided|90.0|55.41|94.55||||||3 hours postdose|
1586258|NCT03465436|2917213|Superiority||LS Mean|89.19|||||2-Sided|90.0|68.77|109.61||||||2.5 hours postdose|
1586259|NCT03465436|2917213|Superiority||LS Mean|74.48|||||2-Sided|90.0|56.32|92.63||||||2 hours postdose|
1586260|NCT03465436|2917213|Superiority||LS Mean|107.11|||||2-Sided|90.0|83.31|130.91||||||1.5 hours postdose|
1586261|NCT03465436|2917213|Superiority||LS Mean|100.15|||||2-Sided|90.0|77.81|122.5||||||1 hour postdose|
1586262|NCT03465436|2917213|Superiority||LS Mean|32.89|||||2-Sided|90.0|11.5|54.28||||||30 minutes postdose|
1586263|NCT03465436|2917214|Superiority||LS Mean|5.74|||||2-Sided|90.0|3.47|8.01||||||24 hours postdose|
1586264|NCT03465436|2917214|Superiority||LS Mean|6.26|||||2-Sided|90.0|4.23|8.28||||||12 hours postdose|
1586265|NCT03465436|2917214|Superiority||LS Mean|8.1|||||2-Sided|90.0|6.01|10.19||||||8 hours postdose|
1586266|NCT03465436|2917214|Superiority||LS Mean|8.12|||||2-Sided|90.0|6.02|10.22||||||6 hours postdose|
1586267|NCT03465436|2917214|Superiority||LS Mean|11.17|||||2-Sided|90.0|9.23|13.1||||||4 hours postdose|
1586268|NCT03465436|2917214|Superiority||LS Mean|12.65|||||2-Sided|90.0|10.76|14.54||||||3.5 hours postdose|
1586269|NCT03465436|2917214|Superiority||LS Mean|12.35|||||2-Sided|90.0|10.42|14.28||||||3 hours postdose|
1586270|NCT03465436|2917214|Superiority||LS Mean|10.81|||||2-Sided|90.0|8.9|12.71||||||2.5 hours postdose|
1586271|NCT03465436|2917214|Superiority||LS Mean|11.5|||||2-Sided|90.0|9.5|13.43||||||2 hours postdose|
1586272|NCT03465436|2917214|Superiority||LS Mean|10.95|||||2-Sided|90.0|9.16|12.74||||||1.5 hours postdose|
1586273|NCT03465436|2917214|Superiority||LS Mean|11.81|||||2-Sided|90.0|9.94|13.69||||||1 hour postdose|
1586274|NCT03465436|2917214|Superiority||LS Mean|7.07|||||2-Sided|90.0|4.72|9.41||||||30 minutes postdose|
1586275|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.48|||||2-Sided|90.0|-2.44|1.48||||||24 hours postdose|
1586276|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.75|||||2-Sided|90.0|-0.19|3.69||||||12 hours postdose|
1586468|NCT03447249|2917527|Superiority||LS Mean Difference|0.39|||||2-Sided|95.0|0.24|0.54|||||||
1586277|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.75|||||2-Sided|90.0|-0.55|4.05||||||8 hours postdose|
1586278|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.77|||||2-Sided|90.0|0.75|4.79||||||6 hours postdose|
1586279|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|5.15|||||2-Sided|90.0|3.02|7.27||||||4 hours postdose|
1586280|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|4.3|||||2-Sided|90.0|2.48|6.12||||||3.5 hours postdose|
1586281|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.41|||||2-Sided|90.0|0.25|4.57||||||3 hours postdose|
1586282|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.61|||||2-Sided|90.0|-0.59|3.81||||||2.5 hours postdose|
1586283|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.64|||||2-Sided|90.0|-0.46|3.73||||||2 hours postdose|
1586284|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.96|||||2-Sided|90.0|-3.02|1.09||||||1.5 hours postdose|
1586285|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.49|||||2-Sided|90.0|-4.59|-0.39||||||1 hour postdose|
1586286|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.64|||||2-Sided|90.0|-6.57|-2.71||||||30 minutes postdose|
1586287|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.79|||||2-Sided|90.0|-1.14|2.72||||||24 hours postdose|
1586288|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.15|||||2-Sided|90.0|-3.87|-0.43||||||12 hours postdose|
1586289|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.47|||||2-Sided|90.0|-4.58|-0.35||||||8 hours postdose|
1586290|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.11|||||2-Sided|90.0|-3.17|0.94||||||6 hours postdose|
1586291|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.66|||||2-Sided|90.0|-3.77|0.44||||||4 hours postdose|
1586292|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.74|||||2-Sided|90.0|-3.86|0.39||||||3.5 hours postdose|
1586293|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.74|||||2-Sided|90.0|-4.9|-0.59||||||3 hours postdose|
1586294|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.53|||||2-Sided|90.0|-6.87|-2.19||||||2.5 hours postdose|
1586295|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.47|||||2-Sided|90.0|-6.64|-2.3||||||2 hours postdose|
1586296|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-5.7|||||2-Sided|90.0|-7.57|-3.82||||||1.5 hours postdose|
1586297|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-5.3|||||2-Sided|90.0|-7.18|-3.42||||||1 hour postdose|
1586298|NCT03465436|2917214|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.49|||||2-Sided|90.0|-6.47|-2.52||||||30 minutes postdose|
1586299|NCT03465436|2917215|Superiority||LS Mean|6.13|||||2-Sided|90.0|3.88|8.38||||||24 hours postdose|
1586300|NCT03465436|2917215|Superiority||LS Mean|6.35|||||2-Sided|90.0|4.32|8.38||||||12 hours postdose|
1586301|NCT03465436|2917215|Superiority||LS Mean|7.87|||||2-Sided|90.0|5.66|10.07||||||8 hours postdose|
1586302|NCT03465436|2917215|Superiority||LS Mean|8.24|||||2-Sided|90.0|6.1|10.39||||||6 hours postdose|
1586303|NCT03465436|2917215|Superiority||LS Mean|11.68|||||2-Sided|90.0|9.83|13.52||||||4 hours postdose|
1586304|NCT03465436|2917215|Superiority||LS Mean|12.19|||||2-Sided|90.0|10.32|14.05||||||3.5 hours postdose|
1586305|NCT03465436|2917215|Superiority||LS Mean|11.99|||||2-Sided|90.0|10.1|13.87||||||3 hours postdose|
1586306|NCT03465436|2917215|Superiority||LS Mean|10.98|||||2-Sided|90.0|9.17|12.79||||||2.5 hours postdose|
1586307|NCT03465436|2917215|Superiority||LS Mean|11.92|||||2-Sided|90.0|9.97|13.87||||||2 hours postdose|
1586308|NCT03465436|2917215|Superiority||LS Mean|11.27|||||2-Sided|90.0|9.54|13.0||||||1.5 hours postdose|
1586309|NCT03465436|2917215|Superiority||LS Mean|12.28|||||2-Sided|90.0|10.47|14.1||||||1 hour postdose|
1586310|NCT03465436|2917215|Superiority||LS Mean|7.32|||||2-Sided|90.0|5.03|9.6||||||30 minutes postdose|
1586311|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.29|||||2-Sided|90.0|-2.21|1.63||||||24 hours postdose|
1586312|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|1.37|||||2-Sided|90.0|-0.57|3.3||||||12 hours postdose|
1586313|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.09|||||2-Sided|90.0|-0.23|4.4||||||8 hours postdose|
1586314|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|3.13|||||2-Sided|90.0|0.93|5.34||||||6 hours postdose|
1586315|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|6.94|||||2-Sided|90.0|4.99|8.89||||||4 hours postdose|
1597168|NCT02915835|2935787|Superiority|||||||0.75|||||||ANCOVA||||
1586316|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|5.28|||||2-Sided|90.0|3.61|6.95||||||3.5 hours postdose|
1586317|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|3.94|||||2-Sided|90.0|1.85|6.03||||||3 hours postdose|
1586318|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.85|||||2-Sided|90.0|0.73|4.98||||||2.5 hours postdose|
1586319|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|2.58|||||2-Sided|90.0|0.58|4.58||||||2 hours postdose|
1586320|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.45|||||2-Sided|90.0|-1.49|2.38||||||1.5 hours postdose|
1586321|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.75|||||2-Sided|90.0|-2.75|1.25||||||1 hour postdose|
1586322|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.83|||||2-Sided|90.0|-5.56|-2.11||||||30 minutes postdose|
1586323|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.21|||||2-Sided|90.0|-1.9|2.33||||||24 hours postdose|
1586324|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.05|||||2-Sided|90.0|-3.77|-0.32||||||12 hours postdose|
1586325|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.73|||||2-Sided|90.0|-4.88|-0.57||||||8 hours postdose|
1586326|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-1.06|||||2-Sided|90.0|-3.22|1.1||||||6 hours postdose|
1586327|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|0.07|||||2-Sided|90.0|-1.84|1.99||||||4 hours postdose|
1586328|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.62|||||2-Sided|90.0|-2.53|1.29||||||3.5 hours postdose|
1586329|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-0.91|||||2-Sided|90.0|-2.84|1.03||||||3 hours postdose|
1586330|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-2.46|||||2-Sided|90.0|-4.41|-0.51||||||2.5 hours postdose|
1586331|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.21|||||2-Sided|90.0|-5.14|-1.28||||||2 hours postdose|
1586332|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-4.1|||||2-Sided|90.0|-5.77|-2.43||||||1.5 hours postdose|
1586333|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.54|||||2-Sided|90.0|-5.18|-1.89||||||1 hour postdose|
1586334|NCT03465436|2917215|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.|LS Mean|-3.5|||||2-Sided|90.0|-5.41|-1.59||||||30 minutes postdose|
1586335|NCT03463031|2917223|Superiority||Least Square Mean Difference|-0.2|Standard Error of the Mean|0.19||0.233|2-Sided|95.0|-0.6|0.1|||Mixed Models Analysis||||
1586336|NCT03463031|2917224|Superiority||Least Square Mean Difference|-0.3|Standard Error of the Mean|0.09|<|0.001|2-Sided|95.0|-0.5|-0.1|||ANCOVA||||
1586337|NCT03463031|2917225|Superiority||Least Square Mean Difference|-0.6|Standard Error of the Mean|0.17|<|0.001|2-Sided|95.0|-1.0|-0.3|||Mixed Models Analysis||||
1586338|NCT03463031|2917226|Superiority||Least Square Mean Difference|-0.6|Standard Error of the Mean|0.17||0.001|2-Sided|95.0|-0.9|-0.2|||Mixed Models Analysis||||
1586339|NCT03461757|2917245|Superiority||Risk Difference (RD)|5.9||||0.0898|2-Sided|95.0|-0.9|12.7||P-Value ≥ 0.05; therefore, all secondary endpoints listed after this endpoint in the hierarchy were not tested.|Cochran-Mantel-Haenszel||||
1586340|NCT03461757|2917246|Superiority||Risk Difference (RD)|6.4||||0.0025|2-Sided|95.0|2.3|10.6|||Cochran-Mantel-Haenszel||||
1586341|NCT03461757|2917247|Superiority||Risk Difference (RD)|5.5||||0.0314|2-Sided|95.0|0.5|10.6|||Cochran-Mantel-Haenszel||||
1586342|NCT03461757|2917248|Superiority||Risk Difference (RD)|8.0|||<|0.0001|2-Sided|95.0|4.9|11.1|||Cochran-Mantel-Haenszel||||
1586343|NCT03461757|2917249|Superiority||Risk Difference (RD)|11.5||||0.0003|2-Sided|95.0|5.3|17.7|||Cochran-Mantel-Haenszel||||
1586344|NCT03461757|2917250|Superiority||Risk Difference (RD)|7.8|||<|0.0001|2-Sided|95.0|4.4|11.1|||Cochran-Mantel-Haenszel||||
1586345|NCT03461757|2917251|Superiority||Risk Difference (RD)|5.8||||0.0128|2-Sided|95.0|1.2|10.4|||Cochran-Mantel-Haenszel||||
1586346|NCT03461757|2917252|Superiority||Risk Difference (RD)|10.1|||<|0.0001|2-Sided|95.0|6.9|13.4|||Cochran-Mantel-Haenszel||||
1586347|NCT03461757|2917253|Superiority||Risk Difference (RD)|12.4|||<|0.0001|2-Sided|95.0|7.1|17.6|||Cochran-Mantel-Haenszel||||
1586348|NCT03461757|2917254|Superiority||Risk Difference (RD)|8.9||||0.0002|2-Sided|95.0|4.3|13.6|||Cochran-Mantel-Haenszel||||
1586349|NCT03461757|2917255|Superiority||Risk Difference (RD)|8.8||||0.0007|2-Sided|95.0|3.7|13.9|||Cochran-Mantel-Haenszel||||
1586350|NCT03461757|2917256|Superiority||Risk Difference (RD)|10.6|||<|0.0001|2-Sided|95.0|6.3|14.9|||Cochran-Mantel-Haenszel||||
1586351|NCT03461757|2917257|Superiority||Risk Difference (RD)|6.8||||0.0018|2-Sided|95.0|2.5|11.0|||Cochran-Mantel-Haenszel||||
1586352|NCT03461757|2917258|Superiority||Risk Difference (RD)|16.9|||<|0.0001|2-Sided|95.0|12.0|21.9|||Cochran-Mantel-Haenszel||||
1586353|NCT03461757|2917259|Superiority||Risk Difference (RD)|12.7|||<|0.0001|2-Sided|95.0|8.3|17.2|||Cochran-Mantel-Haenszel||||
1586354|NCT03461757|2917260|Superiority||Risk Difference (RD)|-15.0|||<|0.0001|2-Sided|95.0|-19.3|-10.7|||Cochran-Mantel-Haenszel||||
1586355|NCT03461757|2917261|Superiority||Risk Difference (RD)|9.3|||<|0.0001|2-Sided|95.0|4.9|13.7|||Cochran-Mantel-Haenszel||||
1586356|NCT03461757|2917262|Superiority||Risk Difference (RD)|20.1|||<|0.0001|2-Sided|95.0|15.1|25.2|||Cochran-Mantel-Haenszel||||
1586357|NCT03461757|2917263|Superiority||Risk Difference (RD)|20.1|||<|0.0001|2-Sided|95.0|15.1|25.2|||Cochran-Mantel-Haenszel||||
1586358|NCT03461757|2917264|Superiority||Risk Difference (RD)|16.1|||<|0.0001|2-Sided|95.0|10.8|21.3|||Cochran-Mantel-Haenszel||||
1586359|NCT03461757|2917265|Superiority||Risk Difference (RD)|8.3||||0.0009|2-Sided|95.0|3.4|13.2|||Cochran-Mantel-Haenszel||||
1586360|NCT03461757|2917266|Superiority||Risk Difference (RD)|10.4|||<|0.0001|2-Sided|95.0|6.5|14.2|||Cochran-Mantel-Haenszel||||
1586361|NCT03460990|2917277|Superiority||LS Mean Difference|13.5|||<|0.0001|2-Sided|95.0|8.8|18.3|||Mixed-effects model for repeated measure||||
1586362|NCT03460990|2917278|Superiority||LS Mean Difference|-48.7|||<|0.0001|2-Sided|95.0|-53.9|-43.5|||Mixed-effects model for repeated measure||||
1586363|NCT03460990|2917279|Superiority||Least Squares (LS) Mean Difference|10.0|||<|0.0001|2-Sided|95.0|7.4|12.5|||Mixed-effects model for repeated measure||||
1586364|NCT03459794|2917284|Other||||||<|0.05|||||||t-test, 1 sided||||
1586365|NCT03459794|2917285|Other|||||||||||||||||All measurements were compared to the same treated/control group at t=0, before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.|We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level. The p-value for each transcript is adjusted for multiple comparisons across all 770 transcripts, using the Benjamini-Yekutieli method. The number reported is the number of transcripts where p=<0.05.
1586366|NCT03459794|2917286|Other|||||||||||||||||All measurements were compared to the same group at t=0, that is before the drug or placebo was administered. We compared the expression levels for each transcript, using the mean levels in each group, not at the individual participant level.|We analyzed the changes is level for each cytokine between the groups. P value was adjusted for multiple comparisons and significance determined using the Holm-Sidak method. The threshold value for statistical significance for the mean value between groups was set at p =<0.05 for each cytokine measured. The number of cytokines that met this threshold is reported.
1586367|NCT03459612|2917289|Superiority||Mean Difference (Final Values)|0.46|Standard Deviation|1.76||0.0097|2-Sided||||||Wilcoxon Signed Rank test||||
1586368|NCT03459612|2917289|Superiority||Mean Difference (Final Values)|0.03|Standard Deviation|0.94||0.959|2-Sided||||||Wilcoxon Signed Rank test||||
1586369|NCT03459612|2917289|Superiority||Mean Difference (Final Values)|-0.12|Standard Deviation|0.56||0.125|2-Sided||||||Wilcoxon Signed Rank test||||
1586370|NCT03459612|2917290|Superiority||Mean Difference (Final Values)|0.12|Standard Deviation|0.54||0.0938|2-Sided||||||Wilcoxon Signed Rank test||||
1586371|NCT03459612|2917290|Superiority||Mean Difference (Final Values)|-0.04|Standard Deviation|0.44||0.5938|2-Sided||||||Wilcoxon Signed Rank test||||
1586372|NCT03459612|2917290|Superiority||Mean Difference (Final Values)|-0.09|Standard Deviation|0.42||0.1563|2-Sided||||||Wilcoxon Signed Rank test||||
1586373|NCT03459612|2917291|Superiority||Mean Difference (Final Values)|0.3|Standard Deviation|1.0||0.0115|2-Sided||||||Wilcoxon Signed Rank test||||
1586374|NCT03459612|2917291|Superiority||Mean Difference (Final Values)|-0.04|Standard Deviation|0.27||0.375|2-Sided||||||Wilcoxon Signed Rank test||||
1586375|NCT03459612|2917291|Superiority||Mean Difference (Final Values)|-0.03|Standard Deviation|0.3||0.6875|2-Sided||||||Wilcoxon Signed Rank test||||
1586376|NCT03459612|2917292|Superiority||Difference of Least Square Means|-2.7|||||2-Sided|95.0|-4.13|-1.27|||||||
1586377|NCT03459612|2917292|Superiority||Difference of Least Square Means|-0.31|||||2-Sided|95.0|-1.71|1.08|||||||
1586378|NCT03459612|2917292|Superiority||Difference of Least Square Means|-0.28|||||2-Sided|95.0|-1.71|1.15|||||||
1586379|NCT03459612|2917293|Superiority||Difference in Least Square Means|-3.81|||||2-Sided|95.0|-5.53|-2.08|||||||
1586380|NCT03459612|2917293|Superiority||Difference in Least Square Means|-0.29|||||2-Sided|95.0|-2.0|1.42|||||||
1586381|NCT03459612|2917293|Superiority||Difference of Least Square Means|-1.79|||||2-Sided|95.0|-3.52|-0.06|||||||
1586382|NCT03459612|2917294|Superiority||Difference in Least Square Means|-0.72|||||2-Sided|95.0|-2.32|0.89|||||||
1586383|NCT03459612|2917294|Superiority||Difference in Lease Square Means|-0.74|||||2-Sided|95.0|-2.49|1.01|||||||
1586384|NCT03459612|2917294|Superiority||Difference in Least Square Means|0.0|||||2-Sided|95.0|-1.61|1.62|||||||
1586385|NCT03459612|2917295|Superiority||Difference of Least Square Means|0.44|||||2-Sided|95.0|-0.09|0.96|||||||
1586386|NCT03459612|2917295|Superiority||Difference of Least Square Means|-0.4|||||2-Sided|95.0|-0.89|0.09|||||||
1586387|NCT03459612|2917295|Superiority||Difference of Least Square Means|-0.58|||||2-Sided|95.0|-1.1|-0.06|||||||
1586388|NCT03459612|2917296|Superiority||Difference of Least Square Means|1.29|||||2-Sided|95.0|0.81|1.78|||||||
1586389|NCT03459612|2917296|Superiority||Differnce of Least Square Means|0.34|||||2-Sided|95.0|-0.14|0.82|||||||
1586390|NCT03459612|2917296|Superiority||Difference of Least Square Means|0.48|||||2-Sided|95.0|0.0|0.96|||||||
1586391|NCT03459612|2917297|Superiority||Difference of Least Square Means|0.81|||||2-Sided|95.0|0.39|1.24|||||||
1586392|NCT03459612|2917297|Superiority||Difference of Least Square Means|0.66|||||2-Sided|95.0|0.22|1.1|||||||
1586393|NCT03459612|2917297|Superiority||Differences of Least Square Mean|0.28|||||2-Sided|95.0|-0.15|0.7|||||||
1586394|NCT03459612|2917298|Non-Inferiority|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means < 4.4.|Difference in LS Means|4.05|||<|0.0001|2-Sided|95.0|2.73|5.38|||Mixed Models Analysis||||
1586395|NCT03459612|2917298|Non-Inferiority|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means < 4.4.|Difference in LS Means|-1.04|||<|0.0001|2-Sided|95.0|-2.4|0.32|||Mixed Models Analysis||||
1586469|NCT03447249|2917529|Superiority||LS Mean Difference|17.9|||<|0.0001|2-Sided|95.0|14.5|21.3|||Mixed-effects model for repeated measure||||
1586396|NCT03459612|2917298|Non-Inferiority|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means < 4.4.|Differnce in LS Means|-0.97|||<|0.0001|2-Sided|95.0|-2.3|0.36|||Mixed Models Analysis||||
1586397|NCT03459612|2917299|Non-Inferiority|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means < 4.4.|Difference in LS Means|4.31|||<|0.0001|2-Sided|95.0|3.17|5.45|||Mixed Models Analysis||||
1586398|NCT03459612|2917299|Non-Inferiority|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means < 4.4.|Difference in LS Means|-0.32|||<|0.0001|2-Sided|95.0|-1.51|0.88|||Mixed Models Analysis||||
1586399|NCT03459612|2917299|Non-Inferiority|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means < 4.4.|Difference in LS Means|-0.12|||<|0.0001|2-Sided|95.0|-1.28|1.04|||Mixed Models Analysis||||
1586400|NCT03459612|2917300|Non-Inferiority|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means < 4.4.|LS Means|4.98|||<|0.0001|2-Sided|95.0|3.58|6.38|||Mixed Models Analysis||||
1586401|NCT03459612|2917300|Non-Inferiority|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in LS means < 4.4.|LS Means|1.76|||<|0.0001|2-Sided|95.0|0.32|3.2|||Mixed Models Analysis||||
1586402|NCT03459612|2917300|Non-Inferiority|Non-inferiority p-value tests null hypothesis that difference in LS means ≥ 4.4 versus alternative hypothesis that difference in Least Square (LS) means < 4.4.|Difference in LS Means|0.98|||<|0.0001|2-Sided|95.0|-0.43|2.39|||Mixed Models Analysis||||
1586403|NCT03458702|2917332|Superiority||||||<|0.05|||||||t-test, 1 sided||||
1586404|NCT03458702|2917333|Superiority|||||||0.026|||||||ANOVA|||ANOVA:TIME|
1586405|NCT03458702|2917333|Equivalence|no difference is expected at baseline|||||>|0.05|||||||ANOVA||||
1586406|NCT03458702|2917334|Superiority|||||||0.016|||||||ANOVA|||ANOVA: TIME|
1586407|NCT03458702|2917334|Equivalence|A difference at baseline was not expected.|||||>|0.05|||||||ANOVA||||
1586408|NCT03458702|2917335|Superiority||||||<|0.001|||||||Chi-squared, Corrected|||ANOVA: TIME|
1586409|NCT03458702|2917335|Superiority||||||<|0.042|||||||ANOVA|||ANOVA: CONDITION X TIME INTERACTION|
1586410|NCT03458702|2917335|Equivalence|It would be hypothesized that there would not be a difference at baseline.|||||>|0.05|||||||ANOVA||||
1586411|NCT03458702|2917336|Superiority|||||||0.005|||||||ANOVA|||ANOVA: TIME|
1586412|NCT03458702|2917336|Superiority||||||<|0.001|||||||ANOVA|||ANOVA: Condition x Time Interaction|
1586413|NCT03458702|2917336|Equivalence|It would be expected at baseline there would be no difference between groups.|||||>|0.05|||||||ANOVA||||
1586414|NCT03458702|2917337|Superiority||||||<|0.001|||||||ANOVA|||ANOVA for TIME|
1586415|NCT03458702|2917337|Equivalence|It would be expected at baseline that there were no differences between groups.|||||>|0.05|||||||t-test, 2 sided||||
1586416|NCT03456960|2917380|Equivalence|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed [30 minutes after starting breakfast] - TAK-438ASA tablet taken in a fasted [without breakfast] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.1969|||||2-Sided|90.0|0.1065|0.2873|||||||
1586417|NCT03456960|2917380|Equivalence|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed [30 minutes after starting breakfast] - TAK-438ASA tablet taken in a fasted [without breakfast] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.4058|||||2-Sided|90.0|0.0803|0.7312|||||||
1586418|NCT03456960|2917381|Equivalence|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed [30 minutes after starting breakfast] - TAK-438ASA tablet taken in a fasted [without breakfast] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.0201|||||2-Sided|90.0|-0.069|0.1092|||||||
1586419|NCT03456960|2917381|Equivalence|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed [30 minutes after starting breakfast] - TAK-438ASA tablet taken in a fasted [without breakfast] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2096|||||2-Sided|90.0|-0.0054|0.4246|||||||
1586420|NCT03456960|2917382|Equivalence|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed [30 minutes after starting breakfast] - TAK-438ASA tablet taken in a fasted [without breakfast] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.0137|||||2-Sided|90.0|-0.0712|0.0986|||||||
1586421|NCT03456960|2917382|Equivalence|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed [30 minutes after starting breakfast] - TAK-438ASA tablet taken in a fasted [without breakfast] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2099|||||2-Sided|90.0|-0.0048|0.4246|||||||
1586422|NCT03456960|2917383|Equivalence|Salicylic acid: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed [30 minutes after starting breakfast] - TAK-438ASA tablet taken in a fasted [without breakfast] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.014|||||2-Sided|90.0|-0.0639|0.0918|||||||
1586969|NCT03404843|2918500|Other||||||<|0.97|||||||ANOVA|||Within group comparison of treatment|
1586423|NCT03456960|2917383|Equivalence|Unchanged aspirin: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed [30 minutes after starting breakfast] - TAK-438ASA tablet taken in a fasted [without breakfast] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2089|||||2-Sided|90.0|-0.0061|0.4239|||||||
1586424|NCT03456960|2917386|Equivalence|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed [30 minutes after starting breakfast] - TAK-438ASA tablet taken in a fasted [without breakfast] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.3653|||||2-Sided|90.0|0.218|0.5126|||||||
1586425|NCT03456960|2917387|Equivalence|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed [30 minutes after starting breakfast] - TAK-438ASA tablet taken in a fasted [without breakfast] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.219|||||2-Sided|90.0|0.1675|0.2706|||||||
1586426|NCT03456960|2917388|Equivalence|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed [30 minutes after starting breakfast] - TAK-438ASA tablet taken in a fasted [without breakfast] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2161|||||2-Sided|90.0|0.1652|0.2671|||||||
1586427|NCT03456960|2917389|Equivalence|TAK-438F: The difference in the LSM between dosing condition (TAK-438ASA tablet taken in a fed [30 minutes after starting breakfast] - TAK-438ASA tablet taken in a fasted [without breakfast] condition) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and dosing condition, sequence, and period as independent variables.|LSM Difference|0.2138|||||2-Sided|90.0|0.1609|0.2667|||||||
1586428|NCT03456960|2917390|Equivalence|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.002|||||2-Sided|90.0|-0.0463|0.0424|||||||
1586429|NCT03456960|2917390|Equivalence|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0148|||||2-Sided|90.0|-0.0734|0.103|||||||
1586430|NCT03456960|2917391|Equivalence|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1366|||||2-Sided|90.0|-0.173|-0.1002|||||||
1586431|NCT03456960|2917391|Equivalence|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1193|||||2-Sided|90.0|-0.2179|-0.0206|||||||
1586432|NCT03456960|2917392|Equivalence|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.1674|||||2-Sided|90.0|-0.2084|-0.1264|||||||
1586433|NCT03456960|2917392|Equivalence|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.146|||||2-Sided|90.0|-0.2478|-0.0443|||||||
1586434|NCT03456960|2917393|Equivalence|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0654|||||2-Sided|90.0|0.0141|0.1167|||||||
1586435|NCT03456960|2917393|Equivalence|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0547|||||2-Sided|90.0|-0.0937|0.2032|||||||
1586436|NCT03456960|2917394|Equivalence|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.0195|||||2-Sided|90.0|-0.0676|0.0286|||||||
1586470|NCT03447249|2917530|Superiority||LS Mean Difference|-43.4|||<|0.0001|2-Sided|95.0|-46.3|-40.5|||Mixed-effects model for repeated measure||||
1586471|NCT03447249|2917531|Superiority||LS Mean Difference|1.11|||<|0.0001|2-Sided|95.0|0.91|1.31|||Mixed-effects model for repeated measure||||
1597169|NCT02915835|2935788|Superiority|||||||0.49|||||||ANCOVA||||
1586437|NCT03456960|2917395|Equivalence|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.015|||||2-Sided|90.0|-0.0448|0.0149|||||||
1586438|NCT03456960|2917396|Equivalence|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|-0.0281|||||2-Sided|90.0|-0.1662|0.11|||||||
1586439|NCT03456960|2917397|Equivalence|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.01|||||2-Sided|90.0|-0.0299|0.05|||||||
1586440|NCT03456960|2917398|Equivalence|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.2293|||||2-Sided|90.0|0.1519|0.3068|||||||
1586441|NCT03456960|2917398|Equivalence|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0916|||||2-Sided|90.0|-0.133|0.3162|||||||
1586442|NCT03456960|2917399|Equivalence|Pivotal Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model will include a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0912|||||2-Sided|90.0|0.0399|0.1424|||||||
1586443|NCT03456960|2917399|Equivalence|Pilot Study 1: The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0546|||||2-Sided|90.0|-0.0941|0.2034|||||||
1586444|NCT03456960|2917400|Equivalence|The difference in the LSM between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0508|||||2-Sided|90.0|-0.0079|0.1096|||||||
1586445|NCT03456960|2917401|Equivalence|The difference in the least square means (LSM) between study medications (TAK-438ASA tablet - concomitant administration of TAK-438 tablet and aspirin enteric-coated tablet) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included a log-transformed (natural log) analysis variable as the dependent variable, and study medication, sequence, and period as independent variables.|LSM Difference|0.0059|||||2-Sided|90.0|-0.034|0.0458|||||||
1586446|NCT03456856|2917402|Superiority||least square mean difference|-4.5|Standard Error of the Mean|1.7||0.013|2-Sided|95.0|-8.0|-1.0|||repeated measures linear model|||The estimated mean treatment difference (95% CI) takes into account a presumed -5 bpm change from baseline heart rate in the absence of ivabradine (as seen in the placebo group in the SHIFT study, (NCT02441218, PMID 20801500).|
1586447|NCT03455491|2917416|Superiority|||||||0.4551|||||||ANOVA|one-way ANOVA|||
1586448|NCT03455491|2917418|Superiority|||||||0.3597|||||||Gekhan-Wilcoxon test||||
1586449|NCT03455491|2917419|Superiority|||||||0.3541|||||||Gekhan-Wilcoxon test||||
1586450|NCT03454581|2917420|Superiority or Other (legacy)|||||||0.05|||||||Generalized Estimating Equation||||
1586451|NCT03454581|2917421|Superiority or Other (legacy)|||||||0.05|||||||Generalized Estimating Equation||||
1586452|NCT03454581|2917422|Superiority or Other (legacy)|||||||0.05|||||||Generalized Estimating Equation||||
1586453|NCT03454581|2917423|Other||||||<|0.01|||||||Generalized Estimating Equation||||
1586454|NCT03454581|2917424|Superiority or Other (legacy)||||||<|0.05|||||||Generalized Estimating Equation||||
1586455|NCT03454581|2917425|Superiority or Other (legacy)|||||||0.05|||||||Generalized Estimating Equation||||
1586456|NCT03454581|2917426|Superiority or Other (legacy)|||||||0.05|||||||Generalized Estimating Equation||||
1586457|NCT03454581|2917427|Superiority||Mean Difference (Final Values)|0.05|||<|0.001|2-Sided|95.0|||||Regression, Linear||||
1586458|NCT03449433|2917497|Superiority||Ratio of LS Means|1.04|||||2-Sided|95.0|0.985|1.1|||||||
1586459|NCT03448536|2917504|Superiority||||||=|0|||||||Cochran-Mantel-Haenszel||||
1586460|NCT03448536|2917506|Superiority||||||<|0.001|||||||Log Rank||||
1586461|NCT03448536|2917507|Superiority||LS Means Difference|3.75|||<|0.001|2-Sided|95.0|2.34|5.16|||ANCOVA||||
1586462|NCT03448536|2917508|Superiority||LS Means Difference|0.56|||=|0|2-Sided|95.0|-0.52|1.64|||ANCOVA||||
1586463|NCT03448536|2917509|Superiority||LS Means Difference|8.27|||<|0.001|2-Sided|95.0|5.76|10.78|||ANCOVA||||
1586464|NCT03448536|2917510|Superiority||LS Means Difference|1.52|||=|0|2-Sided|95.0|-0.45|3.49|||ANCOVA||||
1586465|NCT03448536|2917511|Superiority||LS Means Difference|9.8|||<|0.001|2-Sided|95.0|5.75|13.85|||ANCOVA||||
1586466|NCT03448536|2917512|Superiority||LS Means Difference|4.31|||<|0.001|2-Sided|95.0|2.06|6.56|||ANCOVA||||
1586467|NCT03447249|2917526|Superiority||LS Mean Difference|3.2|||||2-Sided|95.0|2.7|3.8|||||||
1586472|NCT03447249|2917532|Superiority||LS Mean Difference|20.1|||<|0.0001|2-Sided|95.0|17.2|23.0|||Mixed-effects model for repeated measure||||
1586473|NCT03447249|2917533|Superiority||LS Mean Difference|-44.6|||<|0.0001|2-Sided|95.0|-47.2|-41.9|||Mixed-effects model for repeated measure||||
1586474|NCT03447249|2917534|Superiority||Rate ratio|0.14|||<|0.0001|2-Sided|95.0|0.09|0.24|||Negative binomial regression model||||
1586475|NCT03447249|2917535|Superiority||LS Mean Difference|14.2|||<|0.0001|2-Sided|95.0|12.6|15.7|||Mixed-effects model for repeated measure||||
1586476|NCT03447249|2917536|Superiority||Least Squares (LS) Mean Difference|14.0|||<|0.0001|2-Sided|95.0|12.4|15.7|||Mixed-effects model for repeated measure|||The data presented for Primary endpoint was based on interim analysis at Week 4.|
1586477|NCT03445156|2917550|Other|Zero-order correlation||||||0.032|||||||Zero-order correlation|||Hypothesis: A positive correlation was expected between the number of violent shooting games participants listed among their three favorite video games and hits to the mannequin’s head.|
1586478|NCT03445156|2917550|Other|ANCOVA||||||0.645|||||||t-test, 2 sided|t(273) = -0.46||"Hypothesis: participants who played a nonviolent shooting game were expected to hit the mannequin’s torso more often than were participants who played the nonviolent non-shooting game.~Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun."|
1586479|NCT03445156|2917550|Other|ANCOVA||||||0.449|||||||t-test, 2 sided|t(274) = -0.76||Hypothesis: participants who played a nonviolent shooting game were expected to hit the mannequin’s head less often than were participants who played the nonviolent non-shooting game Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun.|
1586480|NCT03445156|2917550|Other|ANCOVA||||||0.17|||||||t-test, 2 sided|t(274) = 2.40||"Hypothesis: Because the nonviolent shooting game rewards other shots, participants who played a nonviolent shooting game were expected to hit the mannequin’s torso more often than were participants who played the nonviolent non-shooting game.~Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun."|
1586481|NCT03445156|2917550|Other|ANCOVA||||||0.044|||||||ANCOVA|F(2, 273) = 3.16||Hypothesis: Participants who played a violent FPS game were expected to hit the mannequin’s head more often than were participants who played either the nonviolent shooting game or the nonviolent non-shooting game Covariates: participant gender, number of guns owned over their lifetime, attitudes toward guns, and number of times they had fired a gun.|
1586482|NCT03445156|2917550|Other|ANCOVA|||||<|0.001|||||||ANCOVA|F(1, 36) = 44.42||Hypothesis: Participants who played a violent FPS game were expected to have more hits to targets with heads or faces than were participants who played a nonviolent shooting game.|
1586483|NCT03445156|2917551|Other|ANCOVA||||||0.0001|||||||ANCOVA|F(1, 36) = 44.42|||
1586484|NCT03445156|2917551|Other|ANCOVA||||||0.04|||||||ANCOVA|F(2, 273) = 3.16, p = .044, partial c^2 = .023|||
1586485|NCT03444584|2917579|Superiority||LS mean difference|-22.17|||<|0.0001|2-Sided|95.0|-30.24|-14.1|||ANCOVA||||
1586486|NCT03444584|2917580|Superiority||LS mean difference|-143.09|||<|0.0001|2-Sided|95.0|-198.2|-87.98|||ANCOVA||||
1586487|NCT03443414|2917594|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.072|||=|0|2-Sided|95.0|0.008|0.137|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo) at Week 4.|
1586488|NCT03443414|2917594|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.085|||=|0|2-Sided|95.0|0.022|0.149|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo) at Week 4.|
1586489|NCT03443414|2917594|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.119|||<|0.001|2-Sided|95.0|0.055|0.183|||LS mean difference|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo) at Week 4.|
1586490|NCT03443414|2917594|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.065|||=|0|2-Sided|95.0|0.001|0.129|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo) at Week 4.|
1586491|NCT03443414|2917594|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.08|||<|0.001|2-Sided|95.0|0.038|0.122|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo) at Day 1.|
1586492|NCT03443414|2917594|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.07|||=|0|2-Sided|95.0|0.028|0.112|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo) at Day 1.|
1586493|NCT03443414|2917594|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.095|||<|0.001|2-Sided|95.0|0.053|0.137|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo) at Day 1.|
1586494|NCT03443414|2917594|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.087|||<|0.001|2-Sided|95.0|0.045|0.129|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo) at Day 1.|
1586514|NCT03443063|2917612|Other||Percent (%) ratio of geometric means|124.94|||||2-Sided|90.0|100.27|155.67|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9|
1586495|NCT03443414|2917595|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.035|||=|0|2-Sided|95.0|-0.028|0.099|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo).|
1586496|NCT03443414|2917595|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.009|||=|0|2-Sided|95.0|-0.053|0.072|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo).|
1586497|NCT03443414|2917595|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.068|||=|0|2-Sided|95.0|0.006|0.13|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo).|
1586498|NCT03443414|2917595|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.002|||=|0|2-Sided|95.0|-0.061|0.065|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo).|
1586499|NCT03443414|2917596|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.146|||<|0.001|2-Sided|95.0|0.075|0.216|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 0.75 mg - Placebo).|
1586500|NCT03443414|2917596|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.153|||<|0.001|2-Sided|95.0|0.083|0.222|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 1.5 mg - Placebo).|
1586501|NCT03443414|2917596|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.2|||<|0.001|2-Sided|95.0|0.131|0.27|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 3.0 mg - Placebo).|
1586502|NCT03443414|2917596|Other|A fixed-sequence testing approach was used, starting with the highest dose versus placebo. If a statistically significant difference was found at the 2-sided alpha level of 5%, the testing proceeded to the next highest dose.|LS mean difference|0.139|||<|0.001|2-Sided|95.0|0.069|0.21|||MMRM|||Placebo-corrected treatment effect: LS mean difference (RPL554 6.0 mg - Placebo).|
1586503|NCT03443063|2917609|Other||Percent (%) ratio of geometric means|140.2|||||2-Sided|90.0|98.11|200.35|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10|
1586504|NCT03443063|2917609|Other||Percent (%) ratio of geometric means|143.31|||||2-Sided|90.0|107.72|190.65|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9|
1586505|NCT03443063|2917609|Other||Percent (%) ratio of geometric means|124.48|||||2-Sided|90.0|100.58|154.06|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4|
1586506|NCT03443063|2917609|Other||Percent (%) ratio of geometric means|141.07|||||2-Sided|90.0|103.79|191.73|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Lemborexant|
1586507|NCT03443063|2917610|Other||Percent (%) ratio of geometric means|136.42|||||2-Sided|90.0|98.19|189.54|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10|
1586508|NCT03443063|2917610|Other||Percent (%) ratio of geometric means|147.03|||||2-Sided|90.0|109.06|198.22|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9|
1586509|NCT03443063|2917610|Other||Percent (%) ratio of geometric means|138.62|||||2-Sided|90.0|109.1|176.14|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4|
1586510|NCT03443063|2917611|Other||Percent (%) ratio of geometric means|118.54|||||2-Sided|90.0|87.84|159.97|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10|
1586511|NCT03443063|2917611|Other||Percent (%) ratio of geometric means|154.29|||||2-Sided|90.0|117.53|202.57|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9|
1586512|NCT03443063|2917611|Other||Percent (%) ratio of geometric means|136.28|||||2-Sided|90.0|105.62|175.85|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4|
1586513|NCT03443063|2917612|Other||Percent (%) ratio of geometric means|92.05|||||2-Sided|90.0|66.87|126.71|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10|
1586625|NCT03441633|2917770|Superiority||Odds Ratio (OR)|1.07||||0|2-Sided|95.0|0.22|5.85|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Over adherence)|
1586515|NCT03443063|2917612|Other||Percent (%) ratio of geometric means|114.69|||||2-Sided|90.0|94.45|139.28|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4|
1586516|NCT03443063|2917613|Other||Percent (%) ratio of geometric means|65.38|||||2-Sided|90.0|41.08|104.04|||||Percent ratio was calculated by dividing the geometric mean of reporting arm “Lemborexant: Severe Renal Impairment” by geometric mean of reporting arm “Lemborexant: Normal Renal Function”, then multiplying the value by 100.|Metabolite M10|
1586517|NCT03443063|2917613|Other||Percent (%) ratio of geometric means|86.71|||||2-Sided|90.0|64.92|115.81|||||Percent ratio was calculated by dividing the geometric mean of reporting arm “Lemborexant: Severe Renal Impairment” by geometric mean of reporting arm “Lemborexant: Normal Renal Function”, then multiplying the value by 100.|Metabolite M9|
1586518|NCT03443063|2917613|Other||Percent (%) ratio of geometric means|80.28|||||2-Sided|90.0|56.81|113.46|||||Percent ratio was calculated by dividing the geometric mean of reporting arm “Lemborexant: Severe Renal Impairment” by geometric mean of reporting arm “Lemborexant: Normal Renal Function”, then multiplying the value by 100.|Metabolite M4|
1586519|NCT03443063|2917613|Other||Percent (%) ratio of geometric mean|111.25|||||2-Sided|90.0|91.69|134.99|||||Percent ratio was calculated by dividing the geometric mean of reporting arm “Lemborexant: Severe Renal Impairment” by geometric mean of reporting arm “Lemborexant: Normal Renal Function”, then multiplying the value by 100.|Lemborexant|
1586520|NCT03443063|2917615|Other||Percent (%) ratio of geometric means|72.49|||||2-Sided|90.0|48.08|109.29|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M10|
1586521|NCT03443063|2917615|Other||Percent (%) ratio of geometric means|79.51|||||2-Sided|90.0|54.48|116.03|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M9|
1586522|NCT03443063|2917615|Other||Percent (%) ratio of geometric means|80.09|||||2-Sided|90.0|56.07|114.4|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."|Metabolite M4|
1586523|NCT03443063|2917616|Other||Percent (%) ratio of geometric means|149.84|||||2-Sided|90.0|113.06|198.58|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."||
1586524|NCT03443063|2917617|Other||Percent (%) ratio of geometric means|150.53|||||2-Sided|90.0|113.16|200.26|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."||
1586525|NCT03443063|2917618|Other||Percent (%) ratio of geometric means|133.03|||||2-Sided|90.0|107.3|164.93|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."||
1586526|NCT03443063|2917619|Other||Percent (%) ratio of geometric means|104.83|||||2-Sided|90.0|77.41|141.97|||||"Percent ratio was calculated by dividing the geometric mean of reporting arm Lemborexant: Severe Renal Impairment by geometric mean of reporting arm Lemborexant: Normal Renal Function, then multiplying the value by 100."||
1586527|NCT03442725|2917626|Other||Geometric Mean Ratio|1.835|||||2-Sided|90.0|0.904|3.726||||||ANOVA comparison of AUC0-tlastu for LP-778902 between test group versus the control group.|
1586528|NCT03442725|2917627|Other||Geometric Mean Ratio|1.828|||||2-Sided|90.0|0.903|3.699||||||ANOVA comparison of AUC0-infu for LP-778902 between test group versus the control group.|
1586529|NCT03442725|2917628|Other||Geometric Mean Ratio|1.727|||||2-Sided|90.0|0.866|3.443||||||ANOVA comparison of Cmaxu for LP-778902 between test group versus the control group.|
1586530|NCT03442725|2917629|Other||Arithmetic Mean Difference|0.019|||||2-Sided|90.0|-0.03|0.068||||||ANOVA comparison of fu of LP-778902 between test group versus the control group.|
1586531|NCT03442725|2917633|Other||Geometric Mean Ratio|1.512|||||2-Sided|90.0|0.915|2.498||||||ANOVA comparison of AUC0-tlast for LP-778902 between test group versus the control group.|
1586532|NCT03442725|2917634|Other||Geometric Mean Ratio|1.506|||||2-Sided|90.0|0.914|2.48||||||ANOVA comparison of AUC0-inf for LP-778902 between test group versus the control group.|
1586533|NCT03442725|2917636|Other|Estimate of the median difference and 90% CIs was determined by Hodges-Lehmann estimation.|Median Difference|0.0||||0.7039|2-Sided|90.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||Comparison of tmax for LP-778902 between test group versus the control group.|
1586534|NCT03442725|2917636|Other|Estimate of the median difference and 90% confidence intervals (CIs) was determined by Hodges-Lehmann estimation.|Median Difference|0.0||||0.7452|2-Sided|90.0|-1.0|0.95|||Wilcoxon (Mann-Whitney)|||Comparison of tmax for telotristat ethyl between test group versus the control group.|
1586535|NCT03442725|2917637|Other||Geometric Mean Ratio|1.423|||||2-Sided|90.0|0.901|2.247||||||ANOVA comparison of Cmax for LP-778902 between test group versus the control group.|
1586536|NCT03442725|2917637|Other||Geometric Mean Ratio|1.297|||||2-Sided|90.0|0.6|2.805||||||Analysis of variance (ANOVA) comparison of Cmax for telotristat ethyl between test group versus the control group.|
1586537|NCT03441984|2917705|Other||Ratio of geometric LS means|1.0036|||||2-Sided|90.0|0.9338|1.0787|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.||
1586538|NCT03441984|2917705|Other||Ratio of geometric LS means|1.0706|||||2-Sided|90.0|0.9961|1.1507|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.||
1586539|NCT03441984|2917705|Other||Ratio of geometric LS means|1.0745|||||2-Sided|90.0|0.9997|1.1549|||||Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented||
1586970|NCT03404206|2918501|Superiority||Least squares means|-15.51|||||2-Sided|95.0|-23.09|-7.93|||||||
1586540|NCT03441984|2917714|Other||Ratio of geometric LS means|1.2466|||||2-Sided|90.0|1.0917|1.4234|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.||
1586541|NCT03441984|2917714|Other||Ratio of geometric LS means|1.253|||||2-Sided|90.0|1.0973|1.4307|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.||
1586542|NCT03441984|2917714|Other||Ratio of geometric LS means|1.5619|||||2-Sided|90.0|1.3678|1.7835|||||Treatment comparison between Pediatric DTG/3TC (DTG 5 mg/3TC 30 mg, 10 dispersible tablets) and Adult DTG (50 mg, 1 conventional tablet) and adult 3TC (300 mg, 1 conventional tablet) is presented||
1586543|NCT03441984|2917722|Other||Ratio of geometric LS means|0.9587|||||2-Sided|90.0|0.876|1.0493|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.||
1586544|NCT03441984|2917722|Other||Ratio of geometric LS means|1.1311|||||2-Sided|90.0|1.0334|1.2379|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented||
1586545|NCT03441984|2917722|Other||Ratio of geometric LS means|1.0844|||||2-Sided|90.0|0.9904|1.1873|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented||
1586546|NCT03441984|2917730|Other||Ratio of geometric LS means|1.1165|||||2-Sided|90.0|0.9376|1.3295|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) is presented||
1586547|NCT03441984|2917730|Other||Ratio of geometric LS means|0.9181|||||2-Sided|90.0|0.7592|1.1103|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented||
1586548|NCT03441984|2917730|Other||Ratio of geometric LS means|1.0251|||||2-Sided|90.0|0.848|1.2392|||||Treatment comparison between Pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg, 10 dispersible tablets) and Adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg, 1 conventional tablet) is presented||
1586549|NCT03441984|2917739|Other||Ratio of geometric LS means|1.2224|||||2-Sided|90.0|1.121|1.333|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.||
1586550|NCT03441984|2917739|Other||Ratio of geometric LS means|1.3501|||||2-Sided|90.0|1.2381|1.4722|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586551|NCT03441984|2917739|Other||Ratio of geometric LS means|1.6503|||||2-Sided|90.0|1.5131|1.8|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586552|NCT03441984|2917745|Other||Ratio of geometric LS means|0.9893|||||2-Sided|90.0|0.8911|1.0983|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.||
1586553|NCT03441984|2917745|Other||Ratio of geometric LS means|0.9198|||||2-Sided|90.0|0.8285|1.0212|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.||
1586554|NCT03441984|2917745|Other||Ratio of geometric LS means|0.91|||||2-Sided|90.0|0.8196|1.0102|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.||
1586555|NCT03441984|2917746|Other||Ratio of geometric LS means|1.0134|||||2-Sided|90.0|0.9527|1.0779|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.||
1586556|NCT03441984|2917746|Other||Ratio of geometric LS means|0.9702|||||2-Sided|90.0|0.9121|1.032|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.||
1586557|NCT03441984|2917746|Other||Ratio of geometric LS means|0.9831|||||2-Sided|90.0|0.9243|1.0457|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.||
1586558|NCT03441984|2917747|Other||Ratio of geometric LS means|1.0201|||||2-Sided|90.0|0.9633|1.0802|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.||
1586559|NCT03441984|2917747|Other||Ratio of geometric LS means|0.9605|||||2-Sided|90.0|0.9059|1.0185|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.||
1586560|NCT03441984|2917747|Other||Ratio of geometric LS means|0.9798|||||2-Sided|90.0|0.9241|1.0389|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.||
1586561|NCT03441984|2917748|Other||Ratio of geometric LS means|1.5348|||||2-Sided|90.0|1.366|1.7245|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.||
1586562|NCT03441984|2917748|Other||Ratio of geometric LS means|1.2873|||||2-Sided|90.0|1.1457|1.4465|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.||
1586563|NCT03441984|2917748|Other||Ratio of geometric LS means|1.9758|||||2-Sided|90.0|1.7585|2.2201|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.||
1586564|NCT03441984|2917749|Other||Ratio of geometric LS means|1.2998|||||2-Sided|90.0|1.1533|1.465|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.||
1586626|NCT03441633|2917770|Superiority||Odds Ratio (OR)|1.11||||0|2-Sided|95.0|0.9|1.37|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Good adherence)|
1586565|NCT03441984|2917749|Other||Ratio of geometric LS means|1.2755|||||2-Sided|90.0|1.1317|1.4375|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.||
1586566|NCT03441984|2917749|Other||Ratio of geometric LS means|1.6578|||||2-Sided|90.0|1.4709|1.8685|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.||
1586567|NCT03441984|2917750|Other||Ratio of geometric LS means|1.2946|||||2-Sided|90.0|1.1536|1.4529|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) is presented.||
1586568|NCT03441984|2917750|Other||Ratio of geometric LS means|1.2698|||||2-Sided|90.0|1.1315|1.425|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet direct to mouth) and pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) is presented.||
1586569|NCT03441984|2917750|Other||Ratio of geometric LS means|1.6439|||||2-Sided|90.0|1.4649|1.8449|||||Treatment comparison of pediatric DTG/3TC (DTG 5 mg/3TC 30 mg dispersible tablet) and adult DTG/3TC (DTG 50 mg/3TC 300 mg tablet) is presented.||
1586570|NCT03441984|2917751|Other||Ratio of geometric LS means|1.0312|||||2-Sided|90.0|0.9558|1.1124|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.||
1586571|NCT03441984|2917751|Other||Ratio of geometric LS means|0.9079|||||2-Sided|90.0|0.8416|0.9795|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586572|NCT03441984|2917751|Other||Ratio of geometric LS means|0.9362|||||2-Sided|90.0|0.8677|1.0101|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586573|NCT03441984|2917752|Other||Ratio of geometric LS means|1.0596|||||2-Sided|90.0|1.0099|1.1117|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.||
1586574|NCT03441984|2917752|Other||Ratio of geometric LS means|0.9432|||||2-Sided|90.0|0.899|0.9896|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586575|NCT03441984|2917752|Other||Ratio of geometric LS means|0.9994|||||2-Sided|90.0|0.9525|1.0486|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586576|NCT03441984|2917753|Other||Ratio of geometric LS means|1.055|||||2-Sided|90.0|1.0061|1.1063|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.||
1586577|NCT03441984|2917753|Other||Ratio of geometric LS means|0.9478|||||2-Sided|90.0|0.9039|0.9939|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586578|NCT03441984|2917753|Other||Ratio of geometric LS means|1.0|||||2-Sided|90.0|0.9536|1.0486|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586579|NCT03441984|2917754|Other||Ratio of geometric LS means|1.0785|||||2-Sided|90.0|1.0123|1.149|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.||
1586580|NCT03441984|2917754|Other||Ratio of geometric LS means|0.9766|||||2-Sided|90.0|0.9167|1.0405|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586581|NCT03441984|2917754|Other||Ratio of geometric LS means|1.0533|||||2-Sided|90.0|0.9885|1.1223|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586582|NCT03441984|2917755|Other||Ratio of geometric LS means|1.0174|||||2-Sided|90.0|0.9892|1.0465|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.||
1586583|NCT03441984|2917755|Other||Ratio of geometric LS means|1.0232|||||2-Sided|90.0|0.9948|1.0524|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586584|NCT03441984|2917755|Other||Ratio of geometric LS means|1.041|||||2-Sided|90.0|1.0121|1.0708|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586585|NCT03441984|2917756|Other||Ratio of geometric LS means|1.0175|||||2-Sided|90.0|0.9893|1.0465|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.||
1586586|NCT03441984|2917756|Other||Ratio of geometric LS means|1.0228|||||2-Sided|90.0|0.9944|1.052|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586587|NCT03441984|2917756|Other||Ratio of geometric LS means|1.0407|||||2-Sided|90.0|1.0118|1.0704|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586588|NCT03441984|2917757|Other||Ratio of geometric LS means|1.2768|||||2-Sided|90.0|1.1746|1.3878|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.||
1586589|NCT03441984|2917757|Other||Ratio of geometric LS means|1.3614|||||2-Sided|90.0|1.2525|1.4798|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586590|NCT03441984|2917757|Other||Ratio of geometric LS means|1.7382|||||2-Sided|90.0|1.5983|1.8904|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586591|NCT03441984|2917758|Other||Ratio of geometric LS means|1.2576|||||2-Sided|90.0|1.1605|1.3629|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented.||
1586592|NCT03441984|2917758|Other||Ratio of geometric LS means|1.3519|||||2-Sided|90.0|1.2475|1.465|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586593|NCT03441984|2917758|Other||Ratio of geometric LS means|1.7001|||||2-Sided|90.0|1.5685|1.8428|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586594|NCT03441984|2917759|Other||Ratio of geometric LS means|1.2541|||||2-Sided|90.0|1.1569|1.3595|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) is presented||
1586595|NCT03441984|2917759|Other||Ratio of geometric LS means|1.3512|||||2-Sided|90.0|1.2465|1.4647|||||Treatment comparison of pediatric TRUMEQ (DTG 5 mg/ABC 60 mg/3TC 30mg dispersible tablet direct to mouth) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented.||
1586596|NCT03441984|2917759|Other||Ratio of geometric LS means|1.6946|||||2-Sided|90.0|1.569|1.8373|||||Treatment comparison of pediatric TRIUMEQ (DTG 5 mg/ABC 60 mg/3TC 30 mg dispersible tablets) and adult TRIUMEQ (DTG 50 mg/ABC 600 mg/3TC 300 mg tablet) is presented||
1586597|NCT03441633|2917768|Superiority||Mean Difference (Final Values)|1.93||||0|2-Sided|95.0|-1.05|4.9|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (NDDDs)|
1586598|NCT03441633|2917768|Superiority||Mean Difference (Final Values)|28.52||||0|2-Sided|95.0|27.56|29.48|||ANOVA|||Warfarin vs. Apixaban in naive participants (NDDDs)|
1586599|NCT03441633|2917768|Superiority||Mean Difference (Final Values)|-2.25||||0|2-Sided|95.0|-4.32|-0.18|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (NDDDs)|
1586600|NCT03441633|2917768|Superiority||Mean Difference (Final Values)|0.9||||0|2-Sided|95.0|0.41|1.39|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (NDDDs)|
1586601|NCT03441633|2917768|Superiority||Mean Difference (Final Values)|1.98||||0|2-Sided|95.0|1.16|2.8|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (NDDDs)|
1586602|NCT03441633|2917768|Superiority||Mean Difference (Final Values)|1.51||||0|2-Sided|95.0|0.84|2.17|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (NDDDs)|
1586603|NCT03441633|2917768|Superiority||Mean Difference (Final Values)|0.11||||0|2-Sided|95.0|-0.77|0.98|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (NDDDs)|
1586604|NCT03441633|2917768|Superiority||Mean Difference (Final Values)|3.63||||0|2-Sided|95.0|3.02|4.24|||ANOVA|||Dabigatran vs. Apixaban in naive participants (NDDDs)|
1586605|NCT03441633|2917769|Superiority||Odds Ratio (OR)|2.92||||0|2-Sided|95.0|2.12|4.05|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Discontinuation first year)|
1586606|NCT03441633|2917769|Superiority||Odds Ratio (OR)|1.41||||0|2-Sided|95.0|1.19|1.67|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Discontinuation first year)|
1586607|NCT03441633|2917769|Superiority||Odds Ratio (OR)|4.82||||0|2-Sided|95.0|3.14|7.55|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Discontinuation first year)|
1586608|NCT03441633|2917769|Superiority||Odds Ratio (OR)|0.89||||0|2-Sided|95.0|0.79|1.01|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Discontinuation first year)|
1586609|NCT03441633|2917769|Superiority||Odds Ratio (OR)|1.18||||0|2-Sided|95.0|0.96|1.47|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Discontinuation first year)|
1586610|NCT03441633|2917769|Superiority||Odds Ratio (OR)|1.09||||0|2-Sided|95.0|0.93|1.27|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Discontinuation first year)|
1586611|NCT03441633|2917769|Superiority||Odds Ratio (OR)|1.45||||0|2-Sided|95.0|1.15|1.83|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Discontinuation first year)|
1586612|NCT03441633|2917769|Superiority||Odds Ratio (OR)|1.08||||0|2-Sided|95.0|0.92|1.27|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Discontinuation first year)|
1586613|NCT03441633|2917770|Superiority||Odds Ratio (OR)|9.73||||0|2-Sided|95.0|2.81|46.5|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Over adherence)|
1586614|NCT03441633|2917770|Superiority||Odds Ratio (OR)|0.1||||0|2-Sided|95.0|0.05|0.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Good adherence)|
1586615|NCT03441633|2917770|Superiority||Odds Ratio (OR)|1.31||||0|2-Sided|95.0|0.91|1.86|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Poor adherence)|
1586616|NCT03441633|2917770|Superiority||Odds Ratio (OR)|29.4||||0|2-Sided|95.0|11.01|123.8|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Over adherence)|
1586617|NCT03441633|2917770|Superiority||Odds Ratio (OR)|0.51||||0|2-Sided|95.0|0.41|0.63|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Good adherence)|
1586618|NCT03441633|2917770|Superiority||Odds Ratio (OR)|0.58||||0|2-Sided|95.0|0.45|0.75|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Poor adherence)|
1586619|NCT03441633|2917770|Superiority||Odds Ratio (OR)|2.07||||0|2-Sided|95.0|0.07|18.0|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Over adherence)|
1586620|NCT03441633|2917770|Superiority||Odds Ratio (OR)|0.01||||0|2-Sided|95.0|0.0|0.09|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Good adherence)|
1586621|NCT03441633|2917770|Superiority||Odds Ratio (OR)|1.23||||0|2-Sided|95.0|0.78|1.91|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants (Poor adherence)|
1586622|NCT03441633|2917770|Superiority||Odds Ratio (OR)|0.34||||0|2-Sided|95.0|0.11|1.52|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Over adherence)|
1586623|NCT03441633|2917770|Superiority||Odds Ratio (OR)|0.11||||0|2-Sided|95.0|0.09|0.13|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Good adherence)|
1586624|NCT03441633|2917770|Superiority||Odds Ratio (OR)|3.37||||0|2-Sided|95.0|2.86|3.99|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants (Poor adherence)|
1597170|NCT02915835|2935789|Superiority|||||||0.4|||||||ANCOVA||||
1586627|NCT03441633|2917770|Superiority||Odds Ratio (OR)|0.65||||0|2-Sided|95.0|0.5|0.85|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Poor adherence)|
1586628|NCT03441633|2917770|Superiority||Odds Ratio (OR)|0.52||||0|2-Sided|95.0|0.06|3.41|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Over adherence)|
1586629|NCT03441633|2917770|Superiority||Odds Ratio (OR)|1.14||||0|2-Sided|95.0|0.95|1.36|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Good adherence)|
1586630|NCT03441633|2917770|Superiority||Odds Ratio (OR)|0.66||||0|2-Sided|95.0|0.52|0.84|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Poor adherence)|
1586631|NCT03441633|2917770|Superiority||Odds Ratio (OR)|0.43||||0|2-Sided|95.0|0.02|3.73|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Over adherence)|
1586632|NCT03441633|2917770|Superiority||Odds Ratio (OR)|0.44||||0|2-Sided|95.0|0.34|0.57|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Good adherence)|
1586633|NCT03441633|2917770|Superiority||Odds Ratio (OR)|1.58||||0|2-Sided|95.0|1.23|2.04|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Poor adherence)|
1586634|NCT03441633|2917770|Superiority||Odds Ratio (OR)|0.1||||0|2-Sided|95.0|0.03|2.01|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Over adherence)|
1586635|NCT03441633|2917770|Superiority||Odds Ratio (OR)|0.67||||0|2-Sided|95.0|0.55|0.82|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Good adherence)|
1586636|NCT03441633|2917770|Superiority||Odds Ratio (OR)|1.41||||0|2-Sided|95.0|1.14|1.75|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Poor adherence)|
1586637|NCT03441633|2917771|Superiority||Odds Ratio (OR)|0.39||||0.008|2-Sided|95.0|0.18|0.86|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants|
1586638|NCT03441633|2917771|Superiority||Odds Ratio (OR)|0.55||||0.008|2-Sided|95.0|0.2|1.99|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants|
1586639|NCT03441633|2917771|Superiority||Odds Ratio (OR)|0.62||||0.008|2-Sided|95.0|0.33|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants|
1586640|NCT03441633|2917771|Superiority||Odds Ratio (OR)|1.88||||0.008|2-Sided|95.0|0.77|5.3|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants|
1586641|NCT03441633|2917772|Superiority||Mean Difference (Final Values)|-0.43||||0|2-Sided|95.0|-0.64|-0.21|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (CHA2DS2Vasc)|
1586642|NCT03441633|2917772|Superiority||Mean Difference (Final Values)|-0.1||||0|2-Sided|95.0|-0.18|-0.01|||ANOVA|||Warfarin vs. Apixaban in naive participants (CHA2DS2Vasc)|
1586643|NCT03441633|2917772|Superiority||Mean Difference (Final Values)|-0.62||||0|2-Sided|95.0|-0.86|-0.37|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (CHA2DS2Vasc)|
1586644|NCT03441633|2917772|Superiority||Mean Difference (Final Values)|0.19||||0|2-Sided|95.0|0.14|0.24|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (CHA2DS2Vasc)|
1586645|NCT03441633|2917772|Superiority||Mean Difference (Final Values)|-0.27||||0|2-Sided|95.0|-0.39|-0.15|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (CHA2DS2Vasc)|
1586646|NCT03441633|2917772|Superiority||Mean Difference (Final Values)|-0.38||||0|2-Sided|95.0|-0.45|-0.32|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (CHA2DS2Vasc)|
1586647|NCT03441633|2917772|Superiority||Mean Difference (Final Values)|-0.33||||0|2-Sided|95.0|-0.46|-0.19|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (CHA2DS2Vasc)|
1586648|NCT03441633|2917772|Superiority||Mean Difference (Final Values)|-0.34||||0|2-Sided|95.0|-0.42|-0.26|||ANOVA|||Dabigatran vs. Apixaban in naive participants (CHA2DS2Vasc)|
1586649|NCT03441633|2917773|Superiority||Mean Difference (Final Values)|-0.37||||0|2-Sided|95.0|-0.54|-0.2|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (CHADS2)|
1586650|NCT03441633|2917773|Superiority||Mean Difference (Final Values)|0.08||||0|2-Sided|95.0|0.01|0.14|||ANOVA|||Warfarin vs. Apixaban in naive participants (CHADS2)|
1586651|NCT03441633|2917773|Superiority||Mean Difference (Final Values)|-0.5||||0|2-Sided|95.0|-0.7|-0.3|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (CHADS2)|
1586652|NCT03441633|2917773|Superiority||Mean Difference (Final Values)|0.21||||0|2-Sided|95.0|0.17|0.25|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (CHADS2)|
1586653|NCT03441633|2917773|Superiority||Mean Difference (Final Values)|-0.21||||0|2-Sided|95.0|-0.31|-0.11|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (CHADS2)|
1586654|NCT03441633|2917773|Superiority||Mean Difference (Final Values)|-0.23||||0|2-Sided|95.0|-0.28|-0.18|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (CHADS2)|
1586655|NCT03441633|2917773|Superiority||Mean Difference (Final Values)|-0.23||||0|2-Sided|95.0|-0.35|-0.12|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (CHADS2)|
1586656|NCT03441633|2917773|Superiority||Mean Difference (Final Values)|-0.18||||0|2-Sided|95.0|-0.24|-0.12|||ANOVA|||Dabigatran vs. Apixaban in naive participants (CHADS2)|
1586657|NCT03441633|2917774|Superiority||Mean Difference (Final Values)|-0.24||||0.001|2-Sided|95.0|-0.37|-0.1|||ANOVA|||Warfarin vs. Apixaban in non-naive participants (HAS - BLED)|
1586658|NCT03441633|2917774|Superiority||Mean Difference (Final Values)|0.17||||0|2-Sided|95.0|0.12|0.23|||ANOVA|||Warfarin vs. Apixaban in naive participants (HAS - BLED)|
1586659|NCT03441633|2917774|Superiority||Mean Difference (Final Values)|-0.17||||0.001|2-Sided|95.0|-0.32|-0.02|||ANOVA|||Acenocumarol vs. Apixaban in non-naive participants (HAS - BLED)|
1586660|NCT03441633|2917774|Superiority||Mean Difference (Final Values)|0.5||||0|2-Sided|95.0|0.47|0.53|||ANOVA|||Acenocumarol vs. Apixaban in naive participants (HAS - BLED)|
1586661|NCT03441633|2917774|Superiority||Mean Difference (Final Values)|-0.11||||0.001|2-Sided|95.0|-0.19|-0.04|||ANOVA|||Rivaroxaban vs. Apixaban in non-naive participants (HAS - BLED)|
1586662|NCT03441633|2917774|Superiority||Mean Difference (Final Values)|-0.19||||0|2-Sided|95.0|-0.23|-0.15|||ANOVA|||Rivaroxaban vs. Apixaban in naive participants (HAS - BLED)|
1586663|NCT03441633|2917774|Superiority||Mean Difference (Final Values)|-0.09||||0.001|2-Sided|95.0|-0.18|-0.01|||ANOVA|||Dabigatran vs. Apixaban in non-naive participants (HAS - BLED)|
1586664|NCT03441633|2917774|Superiority||Mean Difference (Final Values)|-0.22||||0|2-Sided|95.0|-0.26|-0.17|||ANOVA|||Dabigatran vs. Apixaban in naive participants (HAS - BLED)|
1597171|NCT02915835|2935790|Superiority|||||||0.57|||||||ANCOVA||||
1586665|NCT03441633|2917775|Superiority||Odds Ratio (OR)|0.57||||0.052|2-Sided|95.0|0.4|0.84|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants|
1586666|NCT03441633|2917775|Superiority||Odds Ratio (OR)|1.07||||0|2-Sided|95.0|0.95|1.21|||Chi-squared|||Warfarin vs. Apixaban in naive participants|
1586667|NCT03441633|2917775|Superiority||Odds Ratio (OR)|0.74||||0.052|2-Sided|95.0|0.45|1.27|||Chi-squared|||Acenocumarol vs. Apixaban in non-naive participants|
1586668|NCT03441633|2917775|Superiority||Odds Ratio (OR)|1.26||||0|2-Sided|95.0|1.17|1.36|||Chi-squared|||Acenocumarol vs. Apixaban in naive participants|
1586669|NCT03441633|2917775|Superiority||Odds Ratio (OR)|0.79||||0.052|2-Sided|95.0|0.61|1.03|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants|
1586670|NCT03441633|2917775|Superiority||Odds Ratio (OR)|0.73||||0|2-Sided|95.0|0.67|0.8|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants|
1586671|NCT03441633|2917775|Superiority||Odds Ratio (OR)|0.85||||0.052|2-Sided|95.0|0.63|1.15|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants|
1586672|NCT03441633|2917775|Superiority||Odds Ratio (OR)|0.68||||0|2-Sided|95.0|0.61|0.75|||Chi-squared|||Dabigatran vs. Apixaban in naive participants|
1586673|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.67||||0|2-Sided|95.0|0.5|0.87|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (>30 kg per m^2 Obese)|
1586674|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.92||||0.227|2-Sided|95.0|0.72|1.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (25 - 30 kg per m^2 Overweight)|
1586675|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.37||||0.011|2-Sided|95.0|0.18|6.21|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (<18.5 kg per m^2 Underweight)|
1586676|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.27||||0.083|2-Sided|95.0|0.95|1.68|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (18.5 - 25 kg per m^2 Normal)|
1586677|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.95||||0.003|2-Sided|95.0|0.86|1.06|||Chi-squared|||Warfarin vs. Apixaban in naive participants (>30 kg per m^2 Obese)|
1586678|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.28||||0|2-Sided|95.0|1.15|1.43|||Chi-squared|||Warfarin vs. Apixaban in naive participants (25 - 30 kg per m^2 Overweight)|
1586679|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.04||||0.202|2-Sided|95.0|0.36|2.73|||Chi-squared|||Warfarin vs. Apixaban in naive participants (<18.5 kg per m^2 Underweight)|
1586680|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.5||||0|2-Sided|95.0|1.28|1.76|||Chi-squared|||Warfarin vs. Apixaban in naive participants (18.5 - 25 kg per m^2 Normal)|
1586681|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.12||||0|2-Sided|95.0|0.81|1.55|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (>30 kg per m^2 Obese)|
1586682|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.04||||0.227|2-Sided|95.0|0.75|1.42|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (25 - 30 kg per m^2 Overweight)|
1586683|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.49||||0.011|2-Sided|95.0|0.13|8.58|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (<18.5 kg per m^2 Underweight)|
1586684|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.86||||0.083|2-Sided|95.0|0.56|1.28|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (18.5 - 25 kg per m^2 Normal)|
1586685|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.94||||0.003|2-Sided|95.0|0.88|1.0|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (>30 kg per m^2 Obese)|
1586686|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.29||||0|2-Sided|95.0|1.2|1.38|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (25 - 30 kg per m^2 Overweight)|
1586687|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.7||||0.202|2-Sided|95.0|0.98|3.25|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (<18.5 kg per m^2 Underweight)|
1586688|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.63||||0|2-Sided|95.0|1.47|1.82|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (18.5 - 25 kg per m^2 Normal)|
1586689|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.16||||0|2-Sided|95.0|0.99|1.35|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (>30 kg per m^2 Obese)|
1586690|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.84||||0.227|2-Sided|95.0|0.72|0.98|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (25 - 30 kg per m^2 Overweight)|
1586691|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.06||||0.011|2-Sided|95.0|0.02|1.05|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (<18.5 kg per m^2 Underweight)|
1586692|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.97||||0.083|2-Sided|95.0|0.8|1.17|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (18.5 - 25 kg per m^2 Normal)|
1586693|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.87||||0.003|2-Sided|95.0|0.8|0.95|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (>30 kg per m^2 Obese)|
1586694|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.95||||0|2-Sided|95.0|0.87|1.04|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (25 - 30 kg per m^2 Overweight)|
1586695|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.22||||0.202|2-Sided|95.0|0.58|2.66|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (<18.5 kg per m^2 Underweight)|
1586696|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.01||||0|2-Sided|95.0|0.88|1.16|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (18.5 - 25 kg per m^2 Normal)|
1586697|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.23||||0|2-Sided|95.0|1.03|1.47|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (>30 kg per m^2 Obese)|
1586698|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.89||||0.227|2-Sided|95.0|0.75|1.06|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (25 - 30 kg per m^2 Overweight)|
1586699|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.99||||0.011|2-Sided|95.0|0.68|6.18|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (<18.5 kg per m^2 Underweight)|
1586700|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.82||||0.083|2-Sided|95.0|0.66|1.03|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (18.5 - 25 kg per m^2 Normal)|
1586701|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.84||||0.003|2-Sided|95.0|0.76|0.93|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (>30 kg per m^2 Obese)|
1586702|NCT03441633|2917776|Superiority||Odds Ratio (OR)|0.98||||0|2-Sided|95.0|0.88|1.09|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (25 - 30 kg per m^2 Overweight)|
1586703|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.38||||0.202|2-Sided|95.0|0.58|3.23|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (<18.5 kg per m^2 Underweight)|
1586704|NCT03441633|2917776|Superiority||Odds Ratio (OR)|1.07||||0|2-Sided|95.0|0.91|1.25|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (18.5 - 25 kg per m^2 Normal)|
1586705|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.81||||0.14|2-Sided|95.0|0.56|1.15|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 5 - Urban area)|
1586706|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.92||||0.079|2-Sided|95.0|0.67|1.26|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 4 - Urban area)|
1586707|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.76||||0.062|2-Sided|95.0|0.55|1.05|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 3 - Urban area)|
1586708|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.41||||0.124|2-Sided|95.0|1.04|1.88|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 2 - Urban area)|
1586709|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.35||||0.157|2-Sided|95.0|1.0|1.8|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Quintile 1 - Urban area)|
1586710|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.94||||0.013|2-Sided|95.0|0.82|1.08|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 5 - Urban area)|
1586711|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.86||||0|2-Sided|95.0|1.65|2.1|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 4 - Urban area)|
1586712|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.7||||0|2-Sided|95.0|1.51|1.91|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 3 - Urban area)|
1586713|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.84||||0.014|2-Sided|95.0|0.73|0.97|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 2 - Urban area)|
1586714|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.39||||0|2-Sided|95.0|0.32|0.47|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Quintile 1 - Urban area)|
1586715|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.05||||0.14|2-Sided|95.0|0.67|1.59|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 5 - Urban area)|
1586716|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.88||||0.079|2-Sided|95.0|0.57|1.33|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 4 - Urban area)|
1586717|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.75||||0.062|2-Sided|95.0|0.48|1.13|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 3 - Urban area)|
1586718|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.84||||0.124|2-Sided|95.0|0.53|1.29|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 2 - Urban area)|
1586719|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.03||||0.157|2-Sided|95.0|0.68|1.54|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Quintile 1 - Urban area)|
1586720|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.92||||0.013|2-Sided|95.0|0.85|1.0|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 5 - Urban area)|
1586721|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.84||||0|2-Sided|95.0|0.77|0.91|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 4 - Urban area)|
1586722|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.83||||0|2-Sided|95.0|0.76|0.9|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 3 - Urban area)|
1586723|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.91||||0.014|2-Sided|95.0|0.84|0.99|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 2 - Urban area)|
1586724|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.96||||0|2-Sided|95.0|0.88|1.05|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Quintile 1 - Urban area)|
1586725|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.21||||0.14|2-Sided|95.0|0.99|1.49|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 5 - Urban area)|
1586726|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.23||||0.079|2-Sided|95.0|1.02|1.48|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 4 - Urban area)|
1586727|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.79||||0.062|2-Sided|95.0|0.65|0.96|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 3 - Urban area)|
1586728|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.98||||0.124|2-Sided|95.0|0.81|1.2|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 2 - Urban area)|
1586729|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.92||||0.157|2-Sided|95.0|0.76|1.13|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Quintile 1 - Urban area)|
1586730|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.83||||0.013|2-Sided|95.0|0.74|0.93|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 5 - Urban area)|
1586731|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.94||||0|2-Sided|95.0|0.85|1.05|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 4 - Urban area)|
1586732|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.01||||0|2-Sided|95.0|0.91|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 3 - Urban area)|
1586733|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.97||||0.014|2-Sided|95.0|0.87|1.09|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 2 - Urban area)|
1586734|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.31||||0|2-Sided|95.0|1.17|1.45|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Quintile 1 - Urban area)|
1586735|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.09||||0.14|2-Sided|95.0|0.86|1.38|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 5 - Urban area)|
1586736|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.98||||0.079|2-Sided|95.0|0.78|1.22|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 4 - Urban area)|
1586737|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.77||||0.062|2-Sided|95.0|0.61|0.96|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 3 - Urban area)|
1597172|NCT02915835|2935791|Superiority|||||||0.76|||||||ANCOVA||||
1586738|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.03||||0.124|2-Sided|95.0|0.82|1.29|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 2 - Urban area)|
1586739|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.05||||0.157|2-Sided|95.0|0.84|1.31|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Quintile 1 - Urban area)|
1586740|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.85||||0.013|2-Sided|95.0|0.74|0.97|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 5 - Urban area)|
1586741|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.86||||0|2-Sided|95.0|0.75|0.97|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 4 - Urban area)|
1586742|NCT03441633|2917777|Superiority||Odds Ratio (OR)|0.87||||0|2-Sided|95.0|0.77|0.99|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 3 - Urban area)|
1586743|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.01||||0.014|2-Sided|95.0|0.89|1.15|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 2 - Urban area)|
1586744|NCT03441633|2917777|Superiority||Odds Ratio (OR)|1.36||||0|2-Sided|95.0|1.2|1.53|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Quintile 1 - Urban area)|
1586745|NCT03441633|2917778|Superiority||Odds Ratio (OR)|0.64||||0.526|2-Sided|95.0|0.09|2.36|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Risk consumption)|
1586746|NCT03441633|2917778|Superiority||Odds Ratio (OR)|0.91||||0.19|2-Sided|95.0|0.66|1.23|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Moderate intake)|
1586747|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.06||||0.826|2-Sided|95.0|0.84|1.34|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (No intake)|
1586748|NCT03441633|2917778|Superiority||Odds Ratio (OR)|0.92||||0.164|2-Sided|95.0|0.49|1.64|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Risk consumption)|
1586749|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.25||||0|2-Sided|95.0|1.1|1.43|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Moderate intake)|
1586750|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.28||||0|2-Sided|95.0|1.16|1.42|||Chi-squared|||Warfarin vs. Apixaban in naive participants (No intake)|
1586751|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.21||||0.526|2-Sided|95.0|0.17|4.5|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Risk consumption)|
1586752|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.22||||0.19|2-Sided|95.0|0.82|1.76|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Moderate intake)|
1586753|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.04||||0.826|2-Sided|95.0|0.76|1.41|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (No intake)|
1586754|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.36||||0.164|2-Sided|95.0|0.98|1.95|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Risk consumption)|
1586755|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.24||||0|2-Sided|95.0|1.14|1.35|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Moderate intake)|
1586756|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.36||||0|2-Sided|95.0|1.28|1.45|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (No intake)|
1586757|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.26||||0.526|2-Sided|95.0|0.62|2.65|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Risk consumption)|
1586758|NCT03441633|2917778|Superiority||Odds Ratio (OR)|0.93||||0.19|2-Sided|95.0|0.77|1.13|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Moderate intake)|
1586759|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.09||||0.826|2-Sided|95.0|0.95|1.26|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (No intake)|
1586760|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.17||||0.164|2-Sided|95.0|0.76|1.83|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Risk consumption)|
1586761|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.12||||0|2-Sided|95.0|1.01|1.24|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Moderate intake)|
1586762|NCT03441633|2917778|Superiority||Odds Ratio (OR)|0.84||||0|2-Sided|95.0|0.77|0.91|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (No intake)|
1586763|NCT03441633|2917778|Superiority||Odds Ratio (OR)|0.58||||0.526|2-Sided|95.0|0.18|1.57|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Risk consumption)|
1586764|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.16||||0.19|2-Sided|95.0|0.94|1.43|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Moderate intake)|
1586765|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.03||||0.826|2-Sided|95.0|0.87|1.22|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (No intake)|
1586766|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.52||||0.164|2-Sided|95.0|0.94|2.45|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Risk consumption)|
1586767|NCT03441633|2917778|Superiority||Odds Ratio (OR)|1.11||||0|2-Sided|95.0|0.98|1.25|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Moderate intake)|
1586768|NCT03441633|2917778|Superiority||Odds Ratio (OR)|0.99||||0|2-Sided|95.0|0.9|1.09|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (No intake)|
1586769|NCT03441633|2917779|Superiority||Odds Ratio (OR)|0.92||||0.93|2-Sided|95.0|0.7|1.2|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Smoker)|
1586770|NCT03441633|2917779|Superiority||Odds Ratio (OR)|1.25||||0.426|2-Sided|95.0|0.78|1.95|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Ex-smoker)|
1586771|NCT03441633|2917779|Superiority||Odds Ratio (OR)|0.91||||0.755|2-Sided|95.0|0.72|1.17|||Chi-squared|||Warfarin vs. Apixaban in non-naive participants (Non-smoker)|
1586772|NCT03441633|2917779|Superiority||Odds Ratio (OR)|1.72||||0|2-Sided|95.0|1.54|1.93|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Smoker)|
1586773|NCT03441633|2917779|Superiority||Odds Ratio (OR)|1.51||||0|2-Sided|95.0|1.29|1.76|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Ex-smoker)|
1586774|NCT03441633|2917779|Superiority||Odds Ratio (OR)|0.54||||0|2-Sided|95.0|0.49|0.6|||Chi-squared|||Warfarin vs. Apixaban in naive participants (Non-smoker)|
1586971|NCT03404206|2918501|Superiority||Least squares means|-33.72|||||2-Sided|95.0|-41.29|-26.14|||||||
1586775|NCT03441633|2917779|Superiority||Odds Ratio (OR)|1.0||||0.93|2-Sided|95.0|0.7|1.4|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Smoker)|
1586776|NCT03441633|2917779|Superiority||Odds Ratio (OR)|1.48||||0.426|2-Sided|95.0|0.82|2.52|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Ex-smoker)|
1586777|NCT03441633|2917779|Superiority||Odds Ratio (OR)|0.82||||0.755|2-Sided|95.0|0.6|1.13|||Chi-squared|||Acenocoumarol vs. Apixaban in non-naive participants (Non-smoker)|
1586778|NCT03441633|2917779|Superiority||Odds Ratio (OR)|1.16||||0|2-Sided|95.0|1.08|1.26|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Smoker)|
1586779|NCT03441633|2917779|Superiority||Odds Ratio (OR)|1.19||||0|2-Sided|95.0|1.08|1.32|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Ex-smoker)|
1586780|NCT03441633|2917779|Superiority||Odds Ratio (OR)|0.79||||0|2-Sided|95.0|0.74|0.84|||Chi-squared|||Acenocoumarol vs. Apixaban in naive participants (Non-smoker)|
1586781|NCT03441633|2917779|Superiority||Odds Ratio (OR)|0.98||||0.93|2-Sided|95.0|0.81|1.12|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Smoker)|
1586782|NCT03441633|2917779|Superiority||Odds Ratio (OR)|1.13||||0.426|2-Sided|95.0|0.84|1.52|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Ex-smoker)|
1586783|NCT03441633|2917779|Superiority||Odds Ratio (OR)|0.98||||0.755|2-Sided|95.0|0.84|1.14|||Chi-squared|||Rivaroxaban vs. Apixaban in non-naive participants (Non-smoker)|
1586784|NCT03441633|2917779|Superiority||Odds Ratio (OR)|1.08||||0|2-Sided|95.0|0.98|1.19|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Smoker)|
1586785|NCT03441633|2917779|Superiority||Odds Ratio (OR)|1.25||||0|2-Sided|95.0|1.1|1.42|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Ex-smoker)|
1586786|NCT03441633|2917779|Superiority||Odds Ratio (OR)|0.78||||0|2-Sided|95.0|0.72|0.84|||Chi-squared|||Rivaroxaban vs. Apixaban in naive participants (Non-smoker)|
1586787|NCT03441633|2917779|Superiority||Odds Ratio (OR)|0.93||||0.93|2-Sided|95.0|0.77|1.12|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Smoker)|
1586788|NCT03441633|2917779|Superiority||Odds Ratio (OR)|1.32||||0.426|2-Sided|95.0|0.95|1.83|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Ex-smoker)|
1586789|NCT03441633|2917779|Superiority||Odds Ratio (OR)|0.95||||0.755|2-Sided|95.0|0.8|1.13|||Chi-squared|||Dabigatran vs. Apixaban in non-naive participants (Non-smoker)|
1586790|NCT03441633|2917779|Superiority||Odds Ratio (OR)|1.04||||0|2-Sided|95.0|0.93|1.17|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Smoker)|
1586791|NCT03441633|2917779|Superiority||Odds Ratio (OR)|1.32||||0|2-Sided|95.0|1.14|1.52|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Ex-smoker)|
1586792|NCT03441633|2917779|Superiority||Odds Ratio (OR)|0.74||||0|2-Sided|95.0|0.68|0.82|||Chi-squared|||Dabigatran vs. Apixaban in naive participants (Non-smoker)|
1586793|NCT03440424|2917801|Other||Percent ratio of geometric mean|103.59|||||2-Sided|90.0|75.43|142.28|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite|
1586794|NCT03440424|2917801|Other||Percent ratio of geometric mean|94.97|||||2-Sided|90.0|70.31|128.28|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite|
1586795|NCT03440424|2917801|Other||Percent ratio of geometric mean|116.76|||||2-Sided|90.0|89.95|151.56|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite|
1586796|NCT03440424|2917801|Other||Percent ratio of geometric mean|78.46|||||2-Sided|90.0|61.06|100.81|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite|
1586797|NCT03440424|2917801|Other||Percent ratio of geometric mean|116.97|||||2-Sided|90.0|84.66|161.62|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite|
1586798|NCT03440424|2917801|Other||Percent ratio of geometric mean|115.38|||||2-Sided|90.0|83.51|159.42|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite|
1586799|NCT03440424|2917802|Other||Percent ratio of geometric mean|105.2|||||2-Sided|90.0|77.89|142.08|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite|
1586800|NCT03440424|2917802|Other||Percent ratio of geometric mean|109.49|||||2-Sided|90.0|81.07|147.88|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite|
1586801|NCT03440424|2917802|Other||Percent ratio of geometric mean|101.0|||||2-Sided|90.0|80.38|126.9|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite|
1586802|NCT03440424|2917802|Other||Percent ratio of geometric mean|78.62|||||2-Sided|90.0|62.57|98.78|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite|
1586803|NCT03440424|2917802|Other||Percent ratio of geometric mean|103.74|||||2-Sided|90.0|78.16|137.7|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite|
1586804|NCT03440424|2917802|Other||Percent ratio of geometric mean|113.04|||||2-Sided|90.0|85.16|150.05|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite|
1586805|NCT03440424|2917803|Other||Percent ratio of geometric mean|74.48|||||2-Sided|90.0|56.06|98.94|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite|
1586806|NCT03440424|2917803|Other||Percent ratio of geometric mean|95.55|||||2-Sided|90.0|71.92|126.94|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite|
1586807|NCT03440424|2917803|Other||Percent ratio of geometric mean|76.0|||||2-Sided|90.0|62.76|92.02|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite|
1586808|NCT03440424|2917803|Other||Percent ratio of geometric mean|75.41|||||2-Sided|90.0|62.28|91.31|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite|
1586809|NCT03440424|2917803|Other||Percent ratio of geometric mean|85.68|||||2-Sided|90.0|67.41|108.9|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite|
1586810|NCT03440424|2917803|Other||Percent ratio of geometric mean|106.7|||||2-Sided|90.0|83.95|135.62|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite|
1586811|NCT03440424|2917804|Other||Percent ratio of geometric mean|71.81|||||2-Sided|90.0|52.03|99.12|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite|
1586812|NCT03440424|2917804|Other||Percent ratio of geometric mean|94.56|||||2-Sided|90.0|68.5|130.51|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite|
1586813|NCT03440424|2917804|Other||Percent ratio of geometric mean|63.2|||||2-Sided|90.0|50.31|79.38|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite|
1586814|NCT03440424|2917804|Other||Percent ratio of geometric mean|78.98|||||2-Sided|90.0|62.88|99.21|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite|
1586815|NCT03440424|2917804|Other||Percent ratio of geometric mean|69.66|||||2-Sided|90.0|54.03|89.79|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite|
1586816|NCT03440424|2917804|Other||Percent ratio of geometric mean|99.14|||||2-Sided|90.0|76.91|127.81|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite|
1586817|NCT03440424|2917806|Other||Percent ratio of geometric mean|76.56|||||2-Sided|90.0|55.24|106.09|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite|
1586818|NCT03440424|2917806|Other||Percent ratio of geometric mean|94.74|||||2-Sided|90.0|68.37|131.3|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M10 metabolite|
1586819|NCT03440424|2917806|Other||Percent ratio of geometric mean|65.7|||||2-Sided|90.0|46.89|92.05|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite|
1586820|NCT03440424|2917806|Other||Percent ratio of geometric mean|84.36|||||2-Sided|90.0|60.21|118.19|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M9 metabolite|
1586821|NCT03440424|2917806|Other||Percent ratio of geometric mean|72.05|||||2-Sided|90.0|52.12|99.6|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite|
1586822|NCT03440424|2917806|Other||Percent ratio of geometric mean|96.97|||||2-Sided|90.0|70.15|134.06|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.|M4 metabolite|
1586823|NCT03440424|2917807|Other||Percent ratio of geometric mean|166.55|||||2-Sided|90.0|112.31|246.99|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.||
1586824|NCT03440424|2917807|Other||Percent ratio of geometric mean|128.88|||||2-Sided|90.0|88.35|188.02|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.||
1586825|NCT03440424|2917808|Other||Percent ratio of geometric mean|153.56|||||2-Sided|90.0|106.39|221.66|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.||
1586826|NCT03440424|2917808|Other||Percent ratio of geometric mean|125.03|||||2-Sided|90.0|87.96|177.74|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.||
1586827|NCT03440424|2917809|Other||Percent ratio of geometric mean|149.52|||||2-Sided|90.0|109.34|204.47|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.||
1586828|NCT03440424|2917809|Other||Percent ratio of geometric mean|131.91|||||2-Sided|90.0|96.46|180.4|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.||
1586829|NCT03440424|2917810|Other||Percent ratio of geometric mean|115.2|||||2-Sided|90.0|88.98|149.13|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.||
1586830|NCT03440424|2917810|Other||Percent ratio of geometric mean|125.26|||||2-Sided|90.0|96.76|162.16|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.||
1586831|NCT03440424|2917811|Other||Percent ratio of geometric mean|103.24|||||2-Sided|90.0|83.53|127.61|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.||
1586832|NCT03440424|2917811|Other||Percent ratio of geometric mean|122.31|||||2-Sided|90.0|98.95|151.17|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.||
1586922|NCT03421730|2918088|Other||Geometric mean ratio (%)|9.55|||||2-Sided||||||||A: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.
1586833|NCT03440424|2917812|Other||Percent ratio of geometric mean|122.2|||||2-Sided|90.0|91.49|163.24|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.||
1586834|NCT03440424|2917812|Other||Percent ratio of geometric mean|157.86|||||2-Sided|90.0|118.18|210.87|||||Percent ratio of geometric mean was calculated by dividing the geometric mean of test by geometric mean of reference, then multiplying the value by 100.||
1586835|NCT03438383|2917834|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||1.5e-05||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||72 h post-operatively|
1586836|NCT03438383|2917834|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.0035||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||48 h post-operatively|
1586837|NCT03438383|2917834|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.37||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||24 h post-operatively|
1586838|NCT03438383|2917834|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.83||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)|
1586839|NCT03438383|2917835|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.011||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||72 h post-operatively|
1586840|NCT03438383|2917835|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.13||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||48h post-operatively|
1586841|NCT03438383|2917835|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.55||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||24 h post-operatively|
1586842|NCT03438383|2917835|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.05||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)|
1586843|NCT03438383|2917836|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.013||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||72 h post-operatively|
1586844|NCT03438383|2917836|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.008||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||48 h post-operatively|
1586845|NCT03438383|2917836|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.09||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||24 h post-operatively|
1586846|NCT03438383|2917836|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) quantitative research sample size calculator (available online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.75||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)|
1597173|NCT02915835|2935793|Superiority|||||||0.35|||||||Log Rank||||
1586847|NCT03438383|2917837|Superiority|We checked for equivalence of the pre-op (baseline) values between the two groups. We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.001||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||72 h post-operatively|
1586848|NCT03438383|2917837|Superiority|We checked for equivalence of the pre-op (baseline) values between the two groups. We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.008||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||48 hours post-operatively|
1586849|NCT03438383|2917837|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.23||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||24 h post-operatively|
1586850|NCT03438383|2917837|Superiority|We computed (post-hoc) the observed power of the performed tests (ANOVA for repeated measures). We confirmed that the specific sample size, as calculated using the Do-it-Yourself (DiY) sample size calculator (online at: https://blog.exmr.net/ sample-size-calculator) by considering a confidence level of 95% and a 10% margin of error, yielded adequate statistical power (> 80%) for each of the examined variables.||||||0.88||||||The a priori threshold for statistical significance was set at <0.05|ANOVA|||24 h before surgery (pre-operative or baseline values)|
1586851|NCT03438266|2917840|Other||Percentage Difference|-1.7|||||2-Sided|95.0|-7.31|3.98|||||||
1586852|NCT03438266|2917841|Non-Inferiority|If the upper limit of the confidence interval at Month 1 was less than 0.5, then treatment with cannula was considered non-inferior to treatment with needle.|Mean Difference (Final Values)|0.1|||||2-Sided|95.0|-0.05|0.25|||||The 95% CI is based on the paired t-test.|Change from Baseline at Month 1|
1586853|NCT03437564|2917854|Equivalence|The difference in the LS means between the formulations (dosing of one vortioxetine 20 mg tablet - dosing of two vortioxetine 10 mg tablets) and the two-sided 90% CI were provided using a crossover ANOVA model. The shown data were anti-logs of LS means difference and CI. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and treatment condition, group, and period as independent variables.|Point Estimate|0.972|||||2-Sided|90.0|0.937|1.008|||||||
1586854|NCT03437564|2917855|Equivalence|The difference in the least square (LS) means between the formulations (dosing of one Vortioxetine 20 mg tablet - dosing of two Vortioxetine 10 mg tablets) and the two-sided 90% confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The shown data were anti-logs of LS means difference and CI. The ANOVA model included log-transformed (natural log) PK parameters AUClast as dependent variable, and treatment condition, group, and period as independent variables.|Point Estimate|0.996|||||2-Sided|90.0|0.967|1.026|||||||
1586855|NCT03434977|2917889|Other||Ratio|0.989|||||2-Sided|90.0|0.916|1.068||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Vz/F as dependent variable, and treatment condition, group, and period as independent variables.|
1586856|NCT03434977|2917890|Other||Ratio|1.003|||||2-Sided|90.0|0.947|1.062||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters CL/F as dependent variable, and treatment condition, group, and period as independent variables.|
1586857|NCT03434977|2917891|Other||Ratio|1.014|||||2-Sided|90.0|0.959|1.071||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters λz as dependent variable, and treatment condition, group, and period as independent variables.|
1586858|NCT03434977|2917892|Other||Ratio|1.037|||||2-Sided|90.0|0.996|1.081||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRT∞, ev as dependent variable, and treatment condition, group, and period as independent variables.|
1586859|NCT03434977|2917893|Other||Ratio|1.047|||||2-Sided|90.0|1.006|1.091||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters MRTlast, ev as dependent variable, and treatment condition, group, and period as independent variables.|
1586860|NCT03434977|2917894|Other||Ratio|0.985|||||2-Sided|90.0|0.932|1.041||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters T1/2z as dependent variable, and treatment condition, group, and period as independent variables.|
1586917|NCT03423641|2918072|Superiority||Odds Ratio (OR)|0.92||||0.39|2-Sided|95.0|0.75|1.12|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.||
1597174|NCT02915835|2935794|Superiority|||||||0.56|||||||Log Rank||||
1586861|NCT03434977|2917895|Other||Ratio|0.997|||||2-Sided|90.0|0.942|1.056||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUC∞ as dependent variable, and treatment condition, group, and period as independent variables.|
1586862|NCT03434977|2917896|Other||Ratio|0.998|||||2-Sided|90.0|0.943|1.056||||||The shown data were the ratio of the fed conditions divided by the fasted conditions, taking anti-logs of the LS means difference (fed-fasted) or CI. The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters AUClast as dependent variable, and treatment condition, group, and period as independent variables.|
1586863|NCT03434977|2917897|Other||LS-Means Difference|0.9083|||||2-Sided|90.0|0.1821|1.6345||||||The difference in the LS means between treatment conditions (fed-fasted) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (non-natural log) PK parameters tmax as dependent variable, and treatment condition, group, and period as independent variables.|
1586864|NCT03434977|2917898|Other||Ratio|0.937|||||2-Sided|90.0|0.89|0.986||||||The shown data were ratio of fed conditions divided by fasted conditions, taking anti-logs of the least square (LS) means difference (fed-fasted) or confidence interval (CI). The difference in LS means between treatment conditions (fed-fasted) and two-sided 90% CI were provided using a crossover analysis of variance (ANOVA) model. ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and treatment condition, group, and period as independent variables.|
1586865|NCT03434249|2917937|Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1586866|NCT03434249|2917939|Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1586867|NCT03434249|2917940|Other|||||||0.0001|||||||Chi-squared|||"According to the results of a previous trial that looked at a probiotic’s effect on infants with CI, it was estimated that when the sample size in each group is 33, the study has 80% power to detect an absolute difference of 35% in the treatment success rate (15% in the Placebo group and 50% in the treatment group) with a 0,05 alpha level.~The number of infants that was included in the study was 80, with an expected maximum dropout rate of 20%."|
1586868|NCT03433677|2917953|Superiority||LSMeans|0.11||||0.177|2-Sided|95.0|-0.05|0.27|||Mixed Models Analysis||LSMean Difference||
1586869|NCT03433677|2917954|Superiority||LSMean Difference|-2.4||||0.057|2-Sided|95.0|-4.8|0.1|||Mixed Models Analysis||||
1586870|NCT03433677|2917955|Superiority||LSMean Difference|-1.8||||0.304|2-Sided|95.0|-5.3|1.7|||Mixed Models Analysis||||
1586871|NCT03433677|2917956|Superiority|||||||0.028|||||||Wilcoxon (Mann-Whitney)||||
1586872|NCT03433677|2917957|Superiority|||||||0.468|||||||Prescott's Exact test||||
1586873|NCT03433677|2917958|Superiority||Median Difference (Final Values)|0.0||||0.375|2-Sided|95.0|0.0|0.0|||Wilcoxon signed-rank test||||
1586874|NCT03432533|2917963|Non-Inferiority|Conclusions for the primary efficacy hypothesis of efficacy of self-administration of romosozumab by AI/Pen compared with HCP-administered romosozumab by PFS at lumbar spine BMD at Month 6 was made using a 1-sided test with type 1 error rate of 0.025 and noninferiority margin of -2.0%.|LS Mean Difference|-0.1|Standard Error of the Mean|0.6||0.84|2-Sided|95.0|-1.3|1.0|||ANCOVA||||
1586875|NCT03432390|2917966|Superiority||||||<|0.0001|||||||t-test, 2 sided||||
1586876|NCT03431012|2917968|Other||||||=|0||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that Positive framing of the side effects would lead to lower response costs compared to Negative Framing.|
1586877|NCT03431012|2917969|Other||||||=|0||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that Positive framing of the side effects would lead to higher response efficacy.|
1586878|NCT03431012|2917970|Other||||||=|0||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, we predicted that the Agency Assignment would not affect self-efficacy, i.e. people's perceived ability to use the antivirals as recommended.|
1586879|NCT03431012|2917971|Other|||||||0.025||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of severity of the pandemic than the human agency assignment.|
1586880|NCT03431012|2917972|Other||||||=|0||||||Sidak corrections were used to adjust for multiple analyses|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of susceptibility than the human agency assignment.|
1586881|NCT03431012|2917973|Other||||||=|0||||||Sidak corrections were used to adjust for multiple analyses.|MANOVA|||Based on the literature, it was predicted that the Virus Agency would lead to higher worry than the human agency assignment.|
1586882|NCT03431012|2917974|Other||||||>|0.05||||||Sidak corrections were used to adjust for multiple analyses.|ANCOVA|ANCOVAs, setting baseline intentions as a covariate, were performed to determine whether post-exposure mean intentions differed between groups.||We predicted that Virus Agency (VA) and Positive Framing (PF) would lead to greater adherence intentions, compared to the human agency (HA) and negative framing (NF) versions respectively.|
1586883|NCT03430856|2917985|Non-Inferiority|Non inferiority margin is 0.4%|Mean Difference (Net)|0.89|||||2-Sided|95.0|0.414|1.37|||||Insulin Tregopil 30mg - Insulin Aspart||
1586884|NCT03430856|2917985|Non-Inferiority|Change from baseline in HbA1c at 24 weeks of treatment, was analyzed using mixed model for repeated measures (MMRM) where all available post-baseline HbA1c measurements obtained up to Week 24 was entered as the dependent variables; visit and treatment were included as fixed factors, with Baseline HbA1c and stratification factor variables as covariates. Furthermore, the interaction terms of visit by treatment, visit by stratification factors and visit by Baseline HbA1c were included in the model.|Mean Difference (Net)|0.99|||||2-Sided|95.0|0.502|1.47|||||Insulin Tregopil 45 mg - Insulin Aspart||
1586885|NCT03428997|2918003|Equivalence|Mixed-effects model, where the test material/negative control is a fixed effect and the subject is a random effect|Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.11||0.274|||||||2-sided t-test|||Testing hypothesis is that the mean score is equal between the compared treatments.|
1586966|NCT03404843|2918499|Other||||||<|0.05|||||||ANOVA|||Within group comparison of treatment|
1586886|NCT03427892|2918010|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.295||||||Pairwise comparisons were also performed to determine which time points were significantly different from one another. Baseline to week 8 is reported above.|t-test, 2 sided|Pairwise comparisons were also performed to determine which time points were significantly different from one another.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586887|NCT03427892|2918011|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586888|NCT03427892|2918012|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.005||||||Pairwise comparisons were also performed to determine which time points were significantly different from one another. Baseline to week 8 is reported above.|t-test, 2 sided|Pairwise comparisons were also performed to determine which time points were significantly different from one another.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586889|NCT03427892|2918013|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.002||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586890|NCT03427892|2918014|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.002||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586891|NCT03427892|2918015|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.133||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586892|NCT03427892|2918016|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.163||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586967|NCT03404843|2918499|Other||||||<|0.05|||||||ANOVA|||Within group comparison of treatment|
1586893|NCT03427892|2918016|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.022||||||To analyze separate one-way repeated measures analyses of variance (ANOVA) were performed. Time (baseline, week 4, week 8) was included as the within-subject factor.Above is from baseline to week 8 for C-SSRS AA, IA, and ABA.|ANOVA|One-way repeated measures (ANOVA) were performed. Time (baseline, wk 4, wk 8) included as within-subject factor. Above is for C-SSRS AA,IA, and ABA.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586894|NCT03427892|2918017|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586895|NCT03427892|2918018|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.19||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.The above reported is TMT B.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586896|NCT03427892|2918018|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.07||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. The above reported is TMT A.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586897|NCT03427892|2918019|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.306||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.Reported is Inter. score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586898|NCT03427892|2918019|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.221||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. Reported is CW score.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586918|NCT03423641|2918073|Superiority||Odds Ratio (OR)|0.71||||0.01|2-Sided|95.0|0.56|0.91|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.||
1586919|NCT03423641|2918074|Superiority||Odds Ratio (OR)|0.81||||0.68|2-Sided|95.0|0.3|2.2|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.||
1586920|NCT03421730|2918088|Other||Geometric mean ratio (%)|59.75|||||2-Sided||||||||C: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.
1586921|NCT03421730|2918088|Other||Geometric mean ratio (%)|32.42|||||2-Sided||||||||B: n=6, D: n=5||The intra-subject coefficient of variation was 33.04%.
1586968|NCT03404843|2918500|Other||||||<|0.05|||||||ANOVA|||Within group comparison of treatment|
1586899|NCT03427892|2918020|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.56||||||Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.Reported is delay score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586900|NCT03427892|2918020|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.49||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor. The above reported is RAVLT Score|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586901|NCT03427892|2918021|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.||||||0.93||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586902|NCT03427892|2918022|Other|Within subjects design; single group. Intent-to-treat (ITT) sample was used in the analysis, such that all participants who completed the baseline visit and at least one post-baseline assessment were included in the analysis.|||||<|0.001||||||To analyze mood symptoms, cognitive performance, and side effects, separate one-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, and wk 8) was included as the within-subject factor.|ANOVA|One-way repeated measures analyses of variance (ANVOA) were performed. Time (bsl, wk 4, wk8) was included as the within-subject factor.||Primary Aim is to determine if brexpiprazole is associated with a reduction in depressive symptom severity in bipolar disorder outpatients. A sample size of 17 provides 80% power for a paired t-test to compare baseline to exit change scores on the MADRS of 7 (SD 10) (a more conservative change than with even the low 1 mg dose of brexpiprazole in Thase et. al. (2015)) with alpha=.05. A sample size of n=20 will allow for some early withdrawals without postbaseline data (10).|
1586903|NCT03426787|2918029|Superiority||Median Difference (Final Values)|-1.936|||>|0.05|2-Sided|95.0|-7.4086|3.5365|||t-test, 2 sided||||
1586904|NCT03426787|2918030|Superiority||Mean Difference (Final Values)|-0.4717||||0.0463|2-Sided|95.0|-0.9355|-0.00793|||t-test, 2 sided||||
1586905|NCT03426787|2918031|Superiority||Mean Difference (Final Values)|-12.30216|||<|0.001|2-Sided|95.0|-18.95|-5.6531|||t-test, 2 sided||||
1586906|NCT03426631|2918032|Superiority||Median Difference (Final Values)|-11.7||||0.47|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1586907|NCT03423641|2918062|Superiority||Odds Ratio (OR)|0.81||||0.11|2-Sided|95.0|0.63|1.05|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.||
1586908|NCT03423641|2918063|Superiority||Odds Ratio (OR)|0.62||||0.07|2-Sided|95.0|0.37|1.03|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.||
1586909|NCT03423641|2918064|Superiority||Odds Ratio (OR)|0.47||||0.02|2-Sided|95.0|0.25|0.88|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.||
1586910|NCT03423641|2918065|Superiority||Rate Ratio|0.82|||<|0.01|2-Sided|95.0|0.77|0.87|||Poisson Regression||The numerator represents the DAA group while the denominator represents the comparison group for the rate ratio.||
1586911|NCT03423641|2918066|Superiority||Rate Ratio|0.71|||<|0.01|2-Sided|95.0|0.6|0.84|||Poisson Regression||The numerator represents the DAA group while the denominator represents the comparison group for the rate ratio.||
1586912|NCT03423641|2918067|Superiority||Marginal Structural Model|0.61|||<|0.01|2-Sided|95.0|0.49|0.76|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.||
1586913|NCT03423641|2918068|Superiority||Odds Ratio (OR)|0.61||||0.34|2-Sided|95.0|0.22|1.7|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.||
1586914|NCT03423641|2918069|Superiority||Odds Ratio (OR)|0.68||||0.12|2-Sided|95.0|0.42|1.1|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.||
1586915|NCT03423641|2918070|Superiority||Odds Ratio (OR)|0.42|||<|0.01|2-Sided|95.0|0.3|0.59|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.||
1586916|NCT03423641|2918071|Superiority||Odds Ratio (OR)|0.67||||0.01|2-Sided|95.0|0.49|0.9|||Marginal Structural Model||The numerator represents the DAA group while the denominator represents the comparison group for the odds ratio.||
1586923|NCT03421730|2918089|Other||Geometric mean ratio (%)|76.98|||||2-Sided||||||||C: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%
1586924|NCT03421730|2918089|Other||Geometric mean ratio (%)|35.97|||||2-Sided||||||||B: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%
1586925|NCT03421730|2918089|Other||Geometric mean ratio (%)|13.35|||||2-Sided||||||||A: n=4, D: n=4||The intra-subject coefficient of variation was 22.05%.
1586926|NCT03421730|2918090|Other||Geometric mean ratio (%)|59.51|||||2-Sided||||||||C: n=6, D: n=5||The intra-subject coefficient of variation was 25.33%.
1586927|NCT03421730|2918090|Other||Geometric mean ratio (%)|28.18|||||2-Sided||||||||B: n=6, D: n=5||The intra-subject coefficient of variation was 25.33%.
1586928|NCT03421730|2918090|Other||Geometric mean ratio (%)|8.69|||||2-Sided||||||||A: n=6; D: n=5||The intra-subject coefficient of variation was 25.33%.
1586929|NCT03421379|2918096|Non-Inferiority|The pre-defined non-inferiority margin is (10%)|Treatment Difference Wald's Method|0.0|||||2-Sided|95.0|-1.47|1.47|||||||
1586930|NCT03417505|2918247|Superiority||||||>|0.05||||||Calculated p value was >0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided|||
1586931|NCT03417505|2918248|Superiority||||||<|0.05||||||Calculated p value was <0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided|||
1586932|NCT03417505|2918249|Superiority||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|paired, 1-sided|||
1586933|NCT03417505|2918250|Superiority||||||<|0.05||||||Calculated p value was <0.05.|Wilcoxon (Mann-Whitney)|paired, 1-sided|||
1586934|NCT03417505|2918251|Superiority||||||>|0.05||||||Calculated p value was >0.05.|t-test, 1 sided|paired|||
1586935|NCT03417505|2918252|Superiority||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank comparison, one sided p value|||
1586936|NCT03417505|2918253|Superiority||||||<|0.01|||||||t-test, 1 sided|paired 1-sided t-test|||
1586937|NCT03417505|2918254|Superiority||||||<|0.05||||||Calculated p value was <0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank comparisons, one-sided|||
1586938|NCT03417505|2918255|Superiority||||||<|0.01|||||||t-test, 1 sided|Paired t-test comparison|||
1586939|NCT03416985|2918266|Other|||||||0.2161||||||p < 0.05 considered significant|ANOVA|||Compare groups with respect to Gingival scores at 30 days|
1586940|NCT03416985|2918267|Other|||||||0.1561||||||p < 0.05 considered significant|ANOVA|||Compare groups with respect to plaque level after 30 days|
1586941|NCT03414359|2918319|Non-Inferiority|As there is no existing data in the literature that clearly defines a clinically significant reduction in the onset time of anesthesia, the non-inferiority margin was defined a priori based on clinical reasoning.||||||0.1||||||The a priori threshold for statistical significance is, <0.05|Wilcoxon (Mann-Whitney)|||To exclude a clinically important difference between the LEBF group and the chloroprocaine group, given a standard deviation of 4 minutes, and a non-inferiority margin of 3 minutes difference between groups, 62 mother-infant dyads (31 mother-infant dyads in each arm) are required to have a significance level of 5% and a power of 90%. In total, 70 female patients were recruited to account for any withdrawals.|
1586942|NCT03413618|2918323|Superiority|||||||1|||||||Fisher Exact||||
1586943|NCT03413618|2918324|Superiority|||||||0.001|||||||Fisher Exact||||
1586944|NCT03413618|2918326|Superiority||||||<|0.0001|||||||Fisher Exact||||
1586945|NCT03413618|2918327|Superiority||||||<|0.0001|||||||Fisher Exact||||
1586946|NCT03413618|2918329|Superiority|||||||0.049|||||||Log Rank||||
1586947|NCT03413618|2918330|Superiority||||||<|0.0001|||||||Fisher Exact||||
1586948|NCT03408392|2918404|Equivalence|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|105.14|||||2-Sided|90.0|96.31|114.78|||||||
1586949|NCT03408392|2918405|Equivalence|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|101.14|||||2-Sided|90.0|93.37|109.55|||||||
1586950|NCT03408392|2918406|Equivalence|Bio-equivalence analysis comparing cefixime test and reference product has been presented.|Percentage ratio|105.38|||||2-Sided|90.0|96.11|115.54|||||||
1586951|NCT03407612|2918418|Equivalence|p < 0.05 required for groups to have non-equivalent results.||||||0.04|||||||t-test, 2 sided||||
1586952|NCT03407612|2918419|Equivalence|p < 0.05 required for groups to have non-equivalent results.||||||0.25|||||||t-test, 2 sided||||
1586953|NCT03407612|2918420|Equivalence|p < 0.05 required for groups to have non-equivalent results.||||||0.78|||||||t-test, 2 sided|||This analysis considers the 6 month postoperative HOS-ADL measures.|
1586954|NCT03407612|2918420|Equivalence|p < 0.05 required for groups to have non-equivalent results.||||||0.87|||||||t-test, 2 sided|||This analysis considers the 12 week postoperative HOS-ADL measures.|
1586955|NCT03407612|2918420|Equivalence|p < 0.05 required for groups to have non-equivalent results.||||||0.73|||||||t-test, 2 sided|||This analysis considers the 6 week postoperative HOS-ADL measures.|
1586956|NCT03407612|2918420|Equivalence|p < 0.05 required for groups to have non-equivalent results.||||||0.67|||||||t-test, 2 sided|||This analysis considers the baseline HOS-ADL measures.|
1586957|NCT03407118|2918430|Superiority||ratio of least square means|0.967|||||2-Sided|95.0|0.803|1.17|||||||
1586958|NCT03406260|2918439|Non-Inferiority|A p-value < 0.05 indicates lasmiditan can be declared noninferior to placebo with noninferiority margin of 10 mmHg, i.e. the difference lasmiditan mean minus placebo mean is less than 10 mmHg.|LS Mean Difference (Final Vaules)|-1.35|||<|0.0001|2-Sided|95.0|-1000.0|2.06|||Linear Mixed Effects Model||||
1586959|NCT03406260|2918439|Non-Inferiority|A p-value < 0.05 indicates lasmiditan can be declared noninferior to placebo with noninferiority margin of 10 mmHg, i.e. the difference lasmiditan mean minus placebo mean is less than 10 mmHg.|LS Mean Difference (Final Vaules)|-1.63|||<|0.0001|2-Sided|95.0|-1000.0|1.81|||Linear Mixed Effects Model||||
1586960|NCT03404843|2918496|Other|||||||0.05|||||||ANOVA|||Within group comparison of treatment|
1586961|NCT03404843|2918496|Other|||||||0.08|||||||ANOVA|||Within group comparison of treatment|
1586962|NCT03404843|2918497|Other|||||||0.3|||||||ANOVA|||Within group comparison of treatment|
1586963|NCT03404843|2918497|Other|||||||0.89|||||||ANOVA|||Within group comparison of treatment|
1586964|NCT03404843|2918498|Other|||||||0.37|||||||ANOVA|||Within group comparison of treatment|
1586965|NCT03404843|2918498|Other|||||||0.28|||||||ANOVA|||Within group comparison of treatment|
1586972|NCT03404206|2918501|Superiority||Least squares means|-18.21|||||2-Sided|95.0|-23.52|-12.89|||||||
1586973|NCT03404206|2918502|Superiority||Least squares means|-38.7|||||2-Sided|95.0|-54.29|-23.11|||||||
1586974|NCT03404206|2918502|Superiority||Least squares means|-73.43|||||2-Sided|95.0|-89.01|-57.85|||||||
1586975|NCT03404206|2918502|Superiority||Least squares means|-34.73|||||2-Sided|95.0|-45.67|-23.8|||||||
1586976|NCT03404206|2918503|Superiority||||||<|0.001|||||||Log Rank||||
1586977|NCT03404206|2918503|Superiority||||||<|0.001|||||||Log Rank||||
1586978|NCT03401671|2918586|Other|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|0.9318|||||2-Sided|90.0|0.8005|1.0846||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.|
1586979|NCT03401671|2918587|Other|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|0.9324|||||2-Sided|90.0|0.8016|1.0846||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.|
1586980|NCT03401671|2918589|Other|Analysis was performed for estimation of least square means only. Descriptive statistical analysis was the main analysis.|Ratio of Geometric least squares Means|1.0229|||||2-Sided|90.0|0.8473|1.2349||||||An analysis of variance was performed with the natural log-transformed PK parameters as the dependent variable and ethnic group as a fixed effect.|
1586981|NCT03400787|2918591|Superiority|||||||0.0001||||||p<0.025 indicates statistical significance.|t-test, 1 sided|||Null hypothesis is that the responder rate for the Latera implant treatment was not superior to the sham treatment. A maximum sample size of 124 evaluable subjects is required for 90% power and preserving a 2.5% (one-sided) type I error rate.|
1586982|NCT03400475|2918592|Superiority|||||||0.34|||||||Fisher Exact||||
1586983|NCT03400475|2918593|Superiority|||||||0.54|||||||Fisher Exact||||
1586984|NCT03400475|2918594|Superiority|||||||0.062|||||||Fisher Exact||||
1586985|NCT03400475|2918595|Superiority|||||||1|||||||Fisher Exact||||
1586986|NCT03400475|2918596|Superiority|||||||0.071|||||||Fisher Exact||||
1586987|NCT03400475|2918597|Superiority|||||||0.071|||||||Fisher Exact||||
1586988|NCT03400475|2918598|Superiority||Mean Difference (Final Values)|1.552||||0.41|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1586989|NCT03400475|2918599|Superiority||Mean Difference (Final Values)|1.6537||||0.41|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1586990|NCT03400475|2918600|Superiority||Mean Difference (Final Values)|37.356||||0.41|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1586991|NCT03400475|2918601|Superiority||Mean Difference (Final Values)|213.314||||0.86|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1586992|NCT03400475|2918602|Superiority||Mean Difference (Final Values)|111.03||||0.86|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1586993|NCT03400475|2918603|Superiority||Mean Difference (Final Values)|-64.696||||0.86|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1586994|NCT03400475|2918604|Superiority||Mean Difference (Final Values)|0.029||||0.9|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1586995|NCT03400475|2918605|Superiority||Mean Difference (Final Values)|0.581||||0.9|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1586996|NCT03400475|2918606|Superiority||Mean Difference (Final Values)|-0.083||||0.9|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1586997|NCT03400475|2918607|Superiority||Mean Difference (Final Values)|3.596||||0.9|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1586998|NCT03400475|2918608|Superiority||Mean Difference (Final Values)|3.59||||0.9|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1586999|NCT03400475|2918609|Superiority||Mean Difference (Final Values)|-2.088||||0.9|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1587000|NCT03398421|2918671|Superiority||Ratio of adjusted geometric mean|0.802|||||2-Sided|90.0|0.69|0.933|||||||
1587001|NCT03398421|2918678|Superiority||Ratio of adjusted geometric mean|2.005|||||2-Sided|90.0|1.807|2.224|||||||
1587002|NCT03395886|2918696|Other|||||||0.8|||||||Generalized estimating equations||||
1587003|NCT03395886|2918697|Other|||||||0.831|||||||Chi-squared|||Summary statistics are expressed as numbers and percentages and compared between groups by Chi-square test.|
1587004|NCT03393208|2918711|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|98.17|||||2-Sided|90.0|91.61|105.21||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state|
1587005|NCT03393208|2918711|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|101.26||||||90.0|94.33|108.69||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state|
1587006|NCT03393208|2918713|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Median Difference|0.25||||||90.0|-0.25|0.5||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state|
1587007|NCT03393208|2918713|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Median Difference|0.0|||||2-Sided|90.0|-0.25|0.25||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state|
1587008|NCT03393208|2918714|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|101.5||||||90.0|93.72|109.92||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state|
1587009|NCT03393208|2918714|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|99.62||||||90.0|92.69|106.77||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state|
1587010|NCT03393208|2918715|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LS Mean Percentage|98.67||||||90.0|91.25|106.69||||||Statistical Comparison of Treatment A Versus Treatment B in Fed state|
1587011|NCT03393208|2918715|Equivalence|Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Ratio of Geometric LeastSquare(LS) Mean%|99.76|||||2-Sided|90.0|92.84|107.2||||||Statistical Comparison of Treatment A Versus Treatment B in Fasting state|
1587012|NCT03392194|2918717|Other|The purpose of this small pilot randomized control trial (RCT) was to assess feasibility and acceptability of conducting community based sleep hygiene and yoga interventions, to be scaled and tested in a future, larger RCT.|Mean Difference (Net)|-2.02||||0.932|2-Sided|95.0|-46.35|50.39|||t-test, 2 sided|Due to main findings, analysis to explore potential mediators of effect were not pursued, despite original plan to explore explanatory variables.||Null hypothesis: There is no difference in change in sleep duration between the two intervention arms.|
1587013|NCT03387683|2918731|Other||Difference in LSM|1.74969|Standard Error of the Mean|2.18363||0.427|2-Sided|95.0|-2.64837|6.14775||Statistical significance was inferred at a (2-sided) 0.05 level.|ANCOVA|The LSM estimate and corresponding p-value were obtained from a linear model with treatment and baseline value of the endpoint as covariates.||Difference in LSM (Placebo - Dapagliflozin 10 mg)|
1587014|NCT03387683|2918732|Other||Difference in LSM|0.31121|Standard Error of the Mean|0.46184||0.504|2-Sided|95.0|-0.619|1.24141||Statistical significance was inferred at a (2-sided) 0.05 level.|ANCOVA|The LSM estimate and corresponding p-value were obtained from a linear model with treatment and baseline value of the endpoint as covariates.||Difference in LSM (Placebo-Dapagliflozin 10 mg)|
1587015|NCT03386448|2918764|Superiority|Student test was performed|Mean Difference (Final Values)|9.0||||0.03|2-Sided||||||t-test, 2 sided||||
1587016|NCT03383887|2918780|Superiority|||||||0.027|||||||Wilcoxon (Mann-Whitney)||||
1587017|NCT03383887|2918781|Superiority||Median Difference (Final Values)|2.7||||0.56|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1587018|NCT03382834|2918854|Superiority|||||||0.73|||||||t-test, 2 sided||||
1587019|NCT03382834|2918856|Superiority|||||||0.68|||||||t-test, 1 sided|The hypothesis was that tamoxifen would enhance the HIV transcription effect of vorinostat (i.e., log10 change would be greater in Arm A than Arm B)|||
1587020|NCT03380429|2918947|Other||Odds Ratio (OR)|0.94||||0.844|2-Sided|95.0|0.49|1.8||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.||
1587021|NCT03380429|2918947|Other||Odds Ratio (OR)|0.85||||0.628|2-Sided|95.0|0.44|1.63||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.||
1587022|NCT03380429|2918947|Other||Odds Ratio (OR)|1.35||||0.383|2-Sided|95.0|0.69|2.67||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.||
1587023|NCT03380429|2918947|Other||Odds Ratio (OR)|0.93||||0.833|2-Sided|95.0|0.48|1.81||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.||
1587024|NCT03380429|2918948|Other||Odds Ratio (OR)|1.01||||0.986|2-Sided|95.0|0.53|1.89||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.||
1587025|NCT03380429|2918948|Other||Odds Ratio (OR)|1.08||||0.814|2-Sided|95.0|0.57|2.04||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.||
1587026|NCT03380429|2918948|Other||Odds Ratio (OR)|1.33||||0.383|2-Sided|95.0|0.7|2.54||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.||
1587027|NCT03380429|2918948|Other||Odds Ratio (OR)|1.04||||0.911|2-Sided|95.0|0.54|1.98||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.||
1587028|NCT03380429|2918949|Other||Odds Ratio (OR)|0.72||||0.321|2-Sided|95.0|0.38|1.38||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.||
1587029|NCT03380429|2918949|Other||Odds Ratio (OR)|0.97||||0.921|2-Sided|95.0|0.51|1.85||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.||
1587030|NCT03380429|2918949|Other||Odds Ratio (OR)|1.24||||0.517|2-Sided|95.0|0.64|2.42||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.||
1587031|NCT03380429|2918949|Other||Odds Ratio (OR)|0.75||||0.385|2-Sided|95.0|0.39|1.44||p-value was calculated using logistic regression|Regression, Logistic||Analysis was performed by logistic regression adjusted for randomized treatment arm, Baseline ACT total score, country, gender and age.||
1587032|NCT03380429|2918950|Other||Mean Difference (Net)|0.3||||0.661|2-Sided|95.0|-0.9|1.4||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.||
1587033|NCT03380429|2918950|Other||Mean Difference (Net)|0.8||||0.164|2-Sided|95.0|-0.3|1.9||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.||
1587034|NCT03380429|2918950|Other||Mean Difference (Net)|0.4||||0.441|2-Sided|95.0|-0.7|1.5||p-value was calculated using MMRM.|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.||
1587061|NCT03376295|2919008|Other||Rate ratio (RR)|0.85|||||2-Sided|95.0|0.55|1.33|||||The RR (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|Severe exacerbation|
1587035|NCT03380429|2918950|Other||Mean Difference (Net)|-0.5||||0.4|2-Sided|95.0|-1.6|0.6||p-value was calculated using Mixed Model Repeated Measures (MMRM).|MMRM||Analysis was performed by MMRM adjusted for randomized treatment arm,Baseline ACT total score,randomized treatment arm-by-visit interaction,Baseline ACT total score-by-visit interaction,gender,age,country and participant fitted as a random factor.||
1587036|NCT03380429|2918952|Other||Mean Difference (Final Values)|7.3||||0.015|2-Sided|95.0|1.5|13.2||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.||
1587037|NCT03380429|2918952|Other||Mean Difference (Final Values)|9.2||||0.002|2-Sided|95.0|3.3|15.1||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.||
1587038|NCT03380429|2918952|Other||Mean Difference (Final Values)|4.8||||0.105|2-Sided|95.0|-1.0|10.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.||
1587039|NCT03380429|2918952|Other||Mean Difference (Final Values)|4.8||||0.118|2-Sided|95.0|-1.2|10.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline rescue use, duration of run-in (visits), country, gender and age.||
1587040|NCT03380429|2918953|Other||Mean Difference (Final Values)|3.4||||0.294|2-Sided|95.0|-3.0|9.9||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.||
1587041|NCT03380429|2918953|Other||Mean Difference (Final Values)|5.9||||0.07|2-Sided|95.0|-0.5|12.4||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.||
1587042|NCT03380429|2918953|Other||Mean Difference (Final Values)|7.1||||0.032|2-Sided|95.0|0.6|13.5||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.||
1587043|NCT03380429|2918953|Other||Mean Difference (Final Values)|9.7||||0.004|2-Sided|95.0|3.1|16.3||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.||
1587044|NCT03380429|2918954|Other||Mean Difference (Final Values)|2.8||||0.359|2-Sided|95.0|-3.1|8.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.||
1587045|NCT03380429|2918954|Other||Mean Difference (Final Values)|5.5||||0.066|2-Sided|95.0|-0.4|11.4||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.||
1587046|NCT03380429|2918954|Other||Mean Difference (Final Values)|7.7||||0.011|2-Sided|95.0|1.8|13.7||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.||
1587047|NCT03380429|2918954|Other||Mean Difference (Final Values)|9.3||||0.003|2-Sided|95.0|3.2|15.3||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.||
1587048|NCT03380429|2918955|Other||Mean Difference (Final Values)|8.1||||0.018|2-Sided|95.0|1.4|14.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.||
1587049|NCT03380429|2918955|Other||Mean Difference (Final Values)|9.3||||0.006|2-Sided|95.0|2.7|16.0||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.||
1587050|NCT03380429|2918955|Other||Mean Difference (Final Values)|8.2||||0.016|2-Sided|95.0|1.6|14.9||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.||
1587051|NCT03380429|2918956|Superiority||Mean Difference (Final Values)|12.0|||<|0.001|2-Sided|95.0|5.2|18.8||p-value was calculated using ANCOVA.|ANCOVA||Analysis was performed by ANCOVA adjusted for randomized treatment arm, Baseline adherence, duration of run-in (visits), country, gender and age.||
1587052|NCT03376516|2918989|Other||Pearson-Copper|0.0|||||2-Sided|95.0|0.0|30.85|||||||
1587053|NCT03376516|2918991|Other|||||||0.9791||||||P-Value for total PK population (N=10)|ANOVA||||
1587054|NCT03376516|2918991|Other|||||||0.9791||||||P-Value for patients aged 6–<12 years (N=5)|ANOVA||||
1587055|NCT03376516|2918991|Other|P-Value for patients aged 1–<6 years (N=5)||||||0.8536|||||||ANOVA||||
1587056|NCT03376516|2918992|Other|||||||0.8273||||||P-Value for total PK population (N=10)|ANOVA||||
1587057|NCT03376516|2918992|Other|||||||0.3752||||||P-Value for patients aged 6–<12 years (N=5)|ANOVA||||
1587058|NCT03376516|2918992|Other|||||||0.9593||||||P-Value for patients aged 1–<6 years (N=5)|ANOVA||||
1587059|NCT03376295|2919007|Other||Hazard Ratio (HR)|0.66|||||2-Sided|95.0|0.48|0.92|||||The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score|The Cox proportional hazard regression model was used to perform an on-treatment analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.|
1587060|NCT03376295|2919007|Other||Hazard Ratio (HR)|0.66|||||2-Sided|95.0|0.42|1.05|||||The HR is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score|The cox proportional hazard regression model was used to perform an as-treated analysis that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.|
1587228|NCT03365934|2919201|Superiority|||||||0.01256|||||||t-test, 2 sided||||
1587229|NCT03365934|2919201|Superiority|||||||0.050032|||||||t-test, 2 sided||||
1587062|NCT03376295|2919008|Other||Rate ratio (RR)|1.07|||||2-Sided|95.0|0.92|1.25|||||The rate ratio (RR) (LABA-TIO combination versus the LABA-ICS combination) is adjusted RR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|Moderate/severe exacerbation|
1587063|NCT03376295|2919009|Other||Hazard Ratio (HR)|0.94|||||2-Sided|95.0|0.65|1.36|||||HR presented is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|The Cox proportional hazard regression model was used to perform for severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.|
1587064|NCT03376295|2919009|Other||Hazard Ratio (HR)|1.04|||||2-Sided|95.0|0.9|1.2|||||The hazard ratio (HR) is adjusted HR after matching on high-dimensional propensity scores, sex and calendar time, adjusted further for the deciles of propensity score.|The Cox proportional hazard regression model was used to perform for moderate/severe exacerbation that assesses the effect of current use of LABA-TIO combination versus the LABA-ICS combination on the risk of a first COPD exacerbation.|
1587065|NCT03373890|2919031|Other|Linear mixed model regression||||||0.34|||||||Regression, Linear||||
1587066|NCT03373890|2919032|Other|LInear mixed model||||||0.008|||||||Regression, Logistic||||
1587067|NCT03373890|2919033|Other|Independent samples Mann Whitney U||||||0.99|||||||Wilcoxon (Mann-Whitney)||||
1587068|NCT03373890|2919034|Other|Independent samples Mann Whitney U||||||0.06|||||||Wilcoxon (Mann-Whitney)||||
1587069|NCT03373890|2919035|Other|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)||||
1587070|NCT03373890|2919036|Other|Independent samples Mann Whitney U||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1587071|NCT03373890|2919037|Other|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)||||
1587072|NCT03373890|2919038|Other|Independent samples Mann Whitney U||||||0.39|||||||Wilcoxon (Mann-Whitney)||||
1587073|NCT03372603|2919068|Other||Ratio|1.336|||||2-Sided|90.0|0.965|1.847|||||Treatment comparison ratio of GSK2798745 and placebo using posterior median ratio and 90% credible interval is presented.||
1587074|NCT03372382|2919076|Equivalence|We prespecified an equivalence margin of -10 to 10mm. We would consider non-opioid analgesia to be equivalent to opioid analgesia if the pain score mean difference between the groups and it’s 95% confidence interval (CI) were within the prespecified margin. Pain score mean difference or 95% CI boundaries outside this range would be considered a clinically important difference between treatments|Mean Difference (Final Values)|4.8|||||2-Sided|95.0|-2.1|11.9|||||The upper boundary of the CI is out of pre-specified limits.|Sample size calculations were based on VAS pain score at 2-4 weeks, assuming a mean of 10mm and standard deviation (SD) of 20 mm in the opioid group Assuming a two-sided alpha level of 0.05 and 80% power to detect equivalence, a total of 138 participants would be needed. To account for a 25% expected attrition rate and crossover, a total of 170 participants would be needed.|
1587075|NCT03372369|2919077|Superiority||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the accuracy of perceived pregnancy risk score between baseline and followup than the CDC poster.|
1587076|NCT03372369|2919077|Superiority||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.|
1587077|NCT03372369|2919077|Superiority||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the CDC poster between baseline and followup is 0.|
1587078|NCT03372369|2919078|Superiority||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the perceived pregnancy risk score between baseline and followup than the CDC poster.|
1587079|NCT03372369|2919078|Superiority||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.|
1587080|NCT03372369|2919078|Superiority||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the perceived pregnancy risk score for the CDC poster between baseline and followup is 0.|
1587081|NCT03372369|2919079|Superiority||||||>|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the effective contraception preference score between baseline and followup than the CDC poster.|
1587082|NCT03372369|2919079|Superiority||||||<|0.01||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the effective contraception preference score for the patient-centered poster between baseline and followup is 0.|
1587083|NCT03372369|2919079|Superiority||||||<|0.001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the effective contraception preference score for the CDC poster between baseline and followup is 0.|
1587084|NCT03372369|2919080|Superiority||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the patient-centered poster does not produce a larger increase in the contraceptive knowledge score between baseline and followup than the CDC poster.|
1587230|NCT03365934|2919201|Superiority|||||||0.999945|||||||t-test, 2 sided||||
1599041|NCT02858401|2938152|Other|||||||1|||||||Fisher Exact||||
1587085|NCT03372369|2919080|Superiority||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the contraceptive knowledge score for the patient-centered poster between baseline and followup is 0.|
1587086|NCT03372369|2919080|Superiority||||||<|0.0001||||||The Bonferroni correction is used to account for multiple comparisons. In this analysis, p<0.01 is the threshold for statistical significance.|t-test, 1 sided|||The null hypothesis is that the change in the contraceptive knowledge score for the CDC poster between baseline and followup is 0.|
1587087|NCT03369704|2919121|Other||ANCOVA|-0.6|Standard Error of the Mean|0.1|||2-Sided|95.0|-0.8|-0.4|||||JRQLQ III||
1587088|NCT03369704|2919121|Other||ANCOVA|-0.51|Standard Error of the Mean|0.093|||2-Sided|95.0|-0.69|-0.33|||||JRQLQ II||
1587089|NCT03369704|2919121|Other||ANCOVA|-0.5|Standard Error of the Mean|0.086|||2-Sided|95.0|-0.66|-0.33|||||JRQLQ I||
1587090|NCT03369704|2919122|Other||Hodges-Lehmann Estimate|-7.0|Standard Error of the Mean|2.81||0.012|2-Sided|95.0|-12.0|-1.0|||van Elteren test||Ocular rescue medication used||
1587091|NCT03369704|2919122|Other||Hodges-Lehmann Estimate|-2.0|Standard Error of the Mean|1.15||0.006|2-Sided|95.0|-4.5|0.0|||van Elteren test||Nasal rescue mediation used||
1587092|NCT03369704|2919123|Other||Hodges-Lehmann Estimate|1.8|Standard Error of the Mean|1.02||0.098|2-Sided|95.0|0.0|4.0|||van Elteren test||Nasal ocular rescue medication free days||
1587093|NCT03369704|2919123|Other||Hodges-Lehmann Estimate|2.0|Standard Error of the Mean|1.21||0.074|2-Sided|95.0|0.0|4.8|||van Elteren test||Ocular rescue medication free days||
1587094|NCT03369704|2919123|Other||Hodges-Lehmann Estimate|1.5|Standard Error of the Mean|0.89||0.011|2-Sided|95.0|0.0|3.5|||van Elteren test||Nasal rescue mediation free days||
1587095|NCT03369704|2919124|Other||ANCOVA|-0.16|Standard Error of the Mean|0.063|||2-Sided|95.0|-0.28|-0.04|||||Nasal ocular rescue medication score||
1587096|NCT03369704|2919124|Other||ANCOVA|-0.08|Standard Error of the Mean|0.04|||2-Sided|95.0|-0.16|0.0|||||Ocular rescue medication score||
1587097|NCT03369704|2919124|Other||ANCOVA|-0.08|Standard Error of the Mean|0.033|||2-Sided|95.0|-0.14|-0.01|||||Nasal rescue mediation score||
1587098|NCT03369704|2919125|Other||Odds Ratio (OR)|3.43||||0.005|2-Sided|95.0|1.21|9.75|||logistic regression||Completely nasal symptom free patients||
1587099|NCT03369704|2919126|Other||Hodges-Lehmann Estimate|4.0|Standard Error of the Mean|1.15|<|0.001|2-Sided|95.0|2.0|6.5|||van Elteren test||Ocular symptom free days||
1587100|NCT03369704|2919126|Other||Hodges-Lehmann Estimate|3.0|Standard Error of the Mean|1.02|<|0.005|2-Sided|95.0|1.0|5.0|||van Elteren test||Nasal symptom free days||
1587101|NCT03369704|2919127|Other||ANCOVA|-0.34|Standard Error of the Mean|0.072|||2-Sided|95.0|-0.48|-0.2|||||score for impairment of daily activities||
1587102|NCT03369704|2919128|Other||ANCOVA|-0.4|Standard Error of the Mean|0.087|||2-Sided|95.0|-0.57|-0.23|||||watery eye score||
1587103|NCT03369704|2919128|Other||ANCOVA|-0.47|Standard Error of the Mean|0.084|||2-Sided|95.0|-0.63|-0.3|||||itchy eye score||
1587104|NCT03369704|2919129|Other||ANCOVA|-0.29|Standard Error of the Mean|0.081|||2-Sided|95.0|-0.45|-0.13|||||nasal congestion score||
1587105|NCT03369704|2919129|Other||ANCOVA|-0.34|Standard Error of the Mean|0.088|||2-Sided|95.0|-0.51|-0.16|||||rhinorrhea score||
1587106|NCT03369704|2919129|Other||ANCOVA|-0.4|Standard Error of the Mean|0.073|||2-Sided|95.0|-0.54|-0.26|||||sneezing score||
1587107|NCT03369704|2919130|Other||ANCOVA|-2.05|Standard Error of the Mean|0.375|||2-Sided|95.0|-2.78|-1.31|||||nasal ocular symptom medication score||
1587108|NCT03369704|2919130|Other||ANCOVA|-0.95|Standard Error of the Mean|0.189|||2-Sided|95.0|-1.32|-0.58|||||ocular symptom medication score||
1587109|NCT03369704|2919130|Other||ANCOVA|-1.1|Standard Error of the Mean|0.229|||2-Sided|95.0|-1.55|-0.64|||||nasal symptom medication score||
1587110|NCT03369704|2919131|Other||ANCOVA|-0.87|Standard Error of the Mean|0.159|||2-Sided|95.0|-1.18|-0.55|||||Ocular symptom||
1587111|NCT03369704|2919131|Other||ANCOVA|-1.89|Standard Error of the Mean|0.331|||2-Sided|95.0|-2.55|-1.24|||||Nasal Ocular Symptom||
1587112|NCT03369704|2919132|Other||Least Square Mean|-1.03|Standard Error of the Mean|0.209|<|0.001|2-Sided|95.0|-1.44|-0.62||"H0: Omalizumab is not different to placebo with respect to mean nasal symptom score over the severe symptom period.~H1: Omalizumab is different to placebo with respect to mean nasal symptom score over the severe symptom period."|ANCOVA||nasal symptom score||
1587113|NCT03365934|2919180|Superiority||Mean Difference (Net)|0.0|Standard Error of the Mean|0.039||0.956|2-Sided|95.0|-0.0799|0.0755|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14|
1587114|NCT03365934|2919180|Superiority||Mean Difference (Net)|-0.08|Standard Error of the Mean|0.039||0.045|2-Sided|95.0|-0.1562|-0.0017|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14|
1587115|NCT03365934|2919180|Superiority||Mean Difference (Net)|-0.09|Standard Error of the Mean|0.039||0.026|2-Sided|95.0|-0.1663|-0.0108|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14|
1587116|NCT03365934|2919180|Superiority||Mean Difference (Net)|0.0|Standard Error of the Mean|0.04||0.937|2-Sided|95.0|-0.0818|0.0755|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14|
1587117|NCT03365934|2919181|Superiority||Mean Difference (Net)|0.01|Standard Error of the Mean|0.048||0.911|2-Sided|95.0|-0.0891|0.0998|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7|
1587118|NCT03365934|2919181|Superiority||Mean Difference (Net)|-0.16|Standard Error of the Mean|0.047||0.001|2-Sided|95.0|-0.2541|-0.0682|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7|
1587119|NCT03365934|2919181|Superiority||Mean Difference (Net)|-0.15|Standard Error of the Mean|0.047||0.002|2-Sided|95.0|-0.2444|-0.0574|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7|
1587231|NCT03365934|2919201|Superiority|||||||0.936394|||||||t-test, 2 sided||||
1587120|NCT03365934|2919181|Superiority||Mean Difference (Net)|-0.13|Standard Error of the Mean|0.047||0.006|2-Sided|95.0|-0.2254|-0.0384|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7|
1587121|NCT03365934|2919182|Superiority||Mean Difference (Net)|0.02|Standard Error of the Mean|0.05||0.646|2-Sided|95.0|-0.0767|0.1231|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6|
1587122|NCT03365934|2919182|Superiority||Mean Difference (Net)|-0.24|Standard Error of the Mean|0.05|<|0.001|2-Sided|95.0|-0.3338|-0.1377|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6|
1587123|NCT03365934|2919182|Superiority||Mean Difference (Net)|-0.27|Standard Error of the Mean|0.05|<|0.001|2-Sided|95.0|-0.3655|-0.1679|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6|
1587124|NCT03365934|2919182|Superiority||Mean Difference (Net)|-0.3|Standard Error of the Mean|0.05|<|0.001|2-Sided|95.0|-0.4019|-0.2044|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6|
1587125|NCT03365934|2919183|Superiority||Mean Difference (Net)|0.12|Standard Error of the Mean|0.052||0.02|2-Sided|95.0|0.0197|0.2252|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5|
1587126|NCT03365934|2919183|Superiority||Mean Difference (Net)|-0.14|Standard Error of the Mean|0.05||0.005|2-Sided|95.0|-0.2439|-0.0457|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5|
1587127|NCT03365934|2919183|Superiority||Mean Difference (Net)|-0.21|Standard Error of the Mean|0.05|<|0.001|2-Sided|95.0|-0.3091|-0.1092|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5|
1587128|NCT03365934|2919183|Superiority||Mean Difference (Net)|-0.23|Standard Error of the Mean|0.051|<|0.001|2-Sided|95.0|-0.3331|-0.1305|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5|
1587129|NCT03365934|2919184|Superiority||Mean Difference (Net)|0.03|Standard Error of the Mean|0.061||0.627|2-Sided|95.0|-0.0902|0.1492|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4|
1587130|NCT03365934|2919184|Superiority||Mean Difference (Net)|-0.07|Standard Error of the Mean|0.06||0.236|2-Sided|95.0|-0.1899|0.0471|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4|
1587131|NCT03365934|2919184|Superiority||Mean Difference (Net)|-0.24|Standard Error of the Mean|0.06|<|0.001|2-Sided|95.0|-0.3614|-0.1243|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4|
1587132|NCT03365934|2919184|Superiority||Mean Difference (Net)|-0.21|Standard Error of the Mean|0.06|<|0.001|2-Sided|95.0|-0.3265|-0.0895|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4|
1587133|NCT03365934|2919185|Superiority||Mean Difference (Net)|0.012|Standard Error of the Mean|0.065||0.061|2-Sided|95.0|-0.0059|0.2515|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3|
1587134|NCT03365934|2919185|Superiority||Mean Difference (Net)|-0.04|Standard Error of the Mean|0.062||0.538|2-Sided|95.0|-0.1622|0.0853|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3|
1587135|NCT03365934|2919185|Superiority||Mean Difference (Net)|-0.15|Standard Error of the Mean|0.062||0.016|2-Sided|95.0|-0.2773|-0.0297|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3|
1587136|NCT03365934|2919185|Superiority||Mean Difference (Net)|-0.07|Standard Error of the Mean|0.062||0.292|2-Sided|95.0|-0.1896|0.0579|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3|
1587137|NCT03365934|2919186|Superiority||Mean Difference (Net)|0.15|Standard Error of the Mean|0.052||0.004|2-Sided|95.0|0.0504|0.2578|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2|
1587138|NCT03365934|2919186|Superiority||Mean Difference (Net)|-0.02|Standard Error of the Mean|0.051||0.671|2-Sided|95.0|-0.1235|0.0798|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2|
1587139|NCT03365934|2919186|Superiority||Mean Difference (Net)|-0.14|Standard Error of the Mean|0.052||0.006|2-Sided|95.0|-0.2459|-0.0412|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2|
1587140|NCT03365934|2919186|Superiority||Mean Difference (Net)|-0.03|Standard Error of the Mean|0.052||0.516|2-Sided|95.0|-0.136|0.0687|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2|
1587141|NCT03365934|2919187|Superiority||Mean Difference (Net)|0.01|Standard Error of the Mean|0.044||0.736|2-Sided|95.0|-0.0725|0.1023|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1|
1587142|NCT03365934|2919187|Superiority||Mean Difference (Net)|-0.06|Standard Error of the Mean|0.043||0.183|2-Sided|95.0|-0.1437|0.0278|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1|
1587143|NCT03365934|2919187|Superiority||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.044||0.019|2-Sided|95.0|-0.1904|-0.0178|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1|
1587144|NCT03365934|2919187|Superiority||Mean Difference (Net)|-0.04|Standard Error of the Mean|0.044||0.348|2-Sided|95.0|-0.129|0.0458|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1|
1599042|NCT02858401|2938154|Other|||||||1|||||||Fisher Exact||||
1587145|NCT03365934|2919189|Superiority||Mean Difference (Net)|0.06|Standard Error of the Mean|3.244||0.985|2-Sided|95.0|-6.3452|6.4683|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 14|
1587146|NCT03365934|2919189|Superiority||Mean Difference (Net)|-9.32|Standard Error of the Mean|3.244||0.005|2-Sided|95.0|-15.7231|-2.9096|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 14|
1587147|NCT03365934|2919189|Superiority||Mean Difference (Net)|0.81|Standard Error of the Mean|3.244||0.804|2-Sided|95.0|-5.6006|7.2129|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 14|
1587148|NCT03365934|2919189|Superiority||Mean Difference (Net)|-2.76|Standard Error of the Mean|3.244||0.397|2-Sided|95.0|-9.1631|3.6504|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 14|
1587149|NCT03365934|2919190|Superiority||Mean Difference (Net)|6.87|Standard Error of the Mean|3.754||0.069|2-Sided|95.0|-0.5447|14.2814|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 7|
1587150|NCT03365934|2919190|Superiority||Mean Difference (Net)|-10.07|Standard Error of the Mean|3.754||0.008|2-Sided|95.0|-17.4867|-2.6606|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 7|
1587151|NCT03365934|2919190|Superiority||Mean Difference (Net)|-11.54|Standard Error of the Mean|3.754||0.002|2-Sided|95.0|-18.9563|-4.1302|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 7|
1587152|NCT03365934|2919190|Superiority||Mean Difference (Net)|-13.95|Standard Error of the Mean|3.754|<|0.001|2-Sided|95.0|-21.368|-6.5419|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 7|
1587153|NCT03365934|2919191|Superiority||Mean Difference (Net)|4.27|Standard Error of the Mean|4.371||0.33|2-Sided|95.0|-4.362|12.9055|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 6|
1587154|NCT03365934|2919191|Superiority||Mean Difference (Net)|-20.63|Standard Error of the Mean|4.371|<|0.001|2-Sided|95.0|-29.2588|-11.9912|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 6|
1587155|NCT03365934|2919191|Superiority||Mean Difference (Net)|-25.33|Standard Error of the Mean|4.371|<|0.001|2-Sided|95.0|-33.9669|-16.6993|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 6|
1587156|NCT03365934|2919191|Superiority||Mean Difference (Net)|-30.9|Standard Error of the Mean|4.371|<|0.001|2-Sided|95.0|-39.5325|-22.265|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 6|
1587157|NCT03365934|2919192|Superiority||Mean Difference (Net)|6.79|Standard Error of the Mean|5.276||0.2|2-Sided|95.0|-3.6303|17.2107|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 5|
1587158|NCT03365934|2919192|Superiority||Mean Difference (Net)|-18.76|Standard Error of the Mean|5.276|<|0.001|2-Sided|95.0|-29.1785|-8.3374|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 5|
1587159|NCT03365934|2919192|Superiority||Mean Difference (Net)|-27.31|Standard Error of the Mean|5.276|<|0.001|2-Sided|95.0|-37.7279|-16.8868|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 5|
1587160|NCT03365934|2919192|Superiority||Mean Difference (Net)|-32.9|Standard Error of the Mean|5.276|<|0.001|2-Sided|95.0|-43.3249|-22.4838|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 5|
1587161|NCT03365934|2919193|Superiority||Mean Difference (Net)|8.75|Standard Error of the Mean|5.39||0.106|2-Sided|95.0|-1.8871|19.3957|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 4|
1587162|NCT03365934|2919193|Superiority||Mean Difference (Net)|-20.99|Standard Error of the Mean|5.39|<|0.001|2-Sided|95.0|-31.6336|-10.3508|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 4|
1587163|NCT03365934|2919193|Superiority||Mean Difference (Net)|-37.84|Standard Error of the Mean|5.39|<|0.001|2-Sided|95.0|-48.4787|-27.1959|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 4|
1587164|NCT03365934|2919193|Superiority||Mean Difference (Net)|-40.39|Standard Error of the Mean|5.39|<|0.001|2-Sided|95.0|-51.0324|-29.7496|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 4|
1587165|NCT03365934|2919194|Superiority||Mean Difference (Net)|10.07|Standard Error of the Mean|4.847||0.039|2-Sided|95.0|0.4969|19.6398|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 3|
1587166|NCT03365934|2919194|Superiority||Mean Difference (Net)|-13.71|Standard Error of the Mean|4.847||0.005|2-Sided|95.0|-23.2784|-4.1355|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 3|
1587167|NCT03365934|2919194|Superiority||Mean Difference (Net)|-27.3|Standard Error of the Mean|4.847|<|0.001|2-Sided|95.0|-36.8727|-17.7298|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 3|
1587168|NCT03365934|2919194|Superiority||Mean Difference (Net)|-31.83|Standard Error of the Mean|4.847|<|0.001|2-Sided|95.0|-41.3967|-22.2538|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 3|
1587232|NCT03365934|2919201|Superiority|||||||0.000948|||||||t-test, 2 sided||||
1587233|NCT03365934|2919201|Superiority|||||||0.004967|||||||t-test, 2 sided||||
1587169|NCT03365934|2919195|Superiority||Mean Difference (Net)|8.39|Standard Error of the Mean|3.038||0.006|2-Sided|95.0|2.3925|14.394|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 2|
1587170|NCT03365934|2919195|Superiority||Mean Difference (Net)|-1.96|Standard Error of the Mean|3.038||0.521|2-Sided|95.0|-7.9571|4.0444|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 2|
1587171|NCT03365934|2919195|Superiority||Mean Difference (Net)|-12.68|Standard Error of the Mean|3.038|<|0.001|2-Sided|95.0|-18.6789|-6.6775|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 2|
1587172|NCT03365934|2919195|Superiority||Mean Difference (Net)|-11.37|Standard Error of the Mean|3.038|<|0.001|2-Sided|95.0|-17.3738|-5.3723|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 2|
1587173|NCT03365934|2919196|Superiority||Mean Difference (Net)|0.72|Standard Error of the Mean|2.851||0.802|2-Sided|95.0|-4.9144|6.3446|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #4 group based on the change from baseline at Day 1|
1587174|NCT03365934|2919196|Superiority||Mean Difference (Net)|-2.41|Standard Error of the Mean|2.851||0.399|2-Sided|95.0|-8.0399|3.2192|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #3 group based on the change from baseline at Day 1|
1587175|NCT03365934|2919196|Superiority||Mean Difference (Net)|-5.08|Standard Error of the Mean|2.851||0.077|2-Sided|95.0|-10.7083|0.5508|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #2 group based on the change from baseline at Day 1|
1587176|NCT03365934|2919196|Superiority||Mean Difference (Net)|-7.5|Standard Error of the Mean|2.851||0.009|2-Sided|95.0|-13.1279|-1.8688|||ANCOVA|||Interpretation of between-treatment comparison between Wounded Uncovered group vs Product #1 group based on the change from baseline at Day 1|
1587177|NCT03365934|2919198|Superiority|||||||0.954163|||||||t-test, 2 sided||||
1587178|NCT03365934|2919198|Superiority|||||||0.005786|||||||t-test, 2 sided||||
1587179|NCT03365934|2919198|Superiority|||||||0.068196|||||||t-test, 2 sided||||
1587180|NCT03365934|2919198|Superiority|||||||0.249909|||||||t-test, 2 sided||||
1587181|NCT03365934|2919198|Superiority|||||||0.777423|||||||t-test, 2 sided||||
1587182|NCT03365934|2919198|Superiority|||||||0.638238|||||||t-test, 2 sided||||
1587183|NCT03365934|2919198|Superiority|||||||0.000974|||||||t-test, 2 sided||||
1587184|NCT03365934|2919198|Superiority|||||||0.017832|||||||t-test, 2 sided||||
1587185|NCT03365934|2919198|Superiority|||||||0.998761|||||||t-test, 2 sided||||
1587186|NCT03365934|2919198|Superiority|||||||0.352008|||||||t-test, 2 sided||||
1587187|NCT03365934|2919198|Superiority|||||||5e-06|||||||t-test, 2 sided||||
1587188|NCT03365934|2919198|Superiority|||||||0.000237|||||||t-test, 2 sided||||
1587189|NCT03365934|2919198|Superiority|||||||0.693615|||||||t-test, 2 sided||||
1587190|NCT03365934|2919198|Superiority|||||||0.022659|||||||t-test, 2 sided||||
1587191|NCT03365934|2919198|Superiority|||||||0.891244|||||||t-test, 2 sided||||
1587192|NCT03365934|2919199|Superiority|||||||0.999494|||||||t-test, 2 sided||||
1587193|NCT03365934|2919199|Superiority|||||||0.22386|||||||t-test, 2 sided||||
1587194|NCT03365934|2919199|Superiority|||||||0.388682|||||||t-test, 2 sided||||
1587195|NCT03365934|2919199|Superiority|||||||0.213798|||||||t-test, 2 sided||||
1587196|NCT03365934|2919199|Superiority|||||||0.385474|||||||t-test, 2 sided||||
1587197|NCT03365934|2919199|Superiority|||||||0.999999|||||||t-test, 2 sided||||
1587198|NCT03365934|2919199|Superiority|||||||0.010747|||||||t-test, 2 sided||||
1587199|NCT03365934|2919199|Superiority|||||||0.033704|||||||t-test, 2 sided||||
1587200|NCT03365934|2919199|Superiority|||||||0.972522|||||||t-test, 2 sided||||
1587201|NCT03365934|2919199|Superiority|||||||0.945179|||||||t-test, 2 sided||||
1587202|NCT03365934|2919199|Superiority|||||||0.022816|||||||t-test, 2 sided||||
1587203|NCT03365934|2919199|Superiority|||||||0.057803|||||||t-test, 2 sided||||
1587204|NCT03365934|2919199|Superiority|||||||0.965993|||||||t-test, 2 sided||||
1587205|NCT03365934|2919199|Superiority|||||||0.938793|||||||t-test, 2 sided||||
1587206|NCT03365934|2919199|Superiority|||||||0.999997|||||||t-test, 2 sided||||
1587207|NCT03365934|2919200|Superiority|||||||0.857177|||||||t-test, 2 sided||||
1587208|NCT03365934|2919200|Superiority|||||||0.060057|||||||t-test, 2 sided||||
1587209|NCT03365934|2919200|Superiority|||||||0.475038|||||||t-test, 2 sided||||
1587210|NCT03365934|2919200|Superiority|||||||0.327918|||||||t-test, 2 sided||||
1587211|NCT03365934|2919200|Superiority|||||||0.946487|||||||t-test, 2 sided||||
1587212|NCT03365934|2919200|Superiority|||||||0.927936|||||||t-test, 2 sided||||
1587213|NCT03365934|2919200|Superiority|||||||0.001348|||||||t-test, 2 sided||||
1587214|NCT03365934|2919200|Superiority|||||||0.052284|||||||t-test, 2 sided||||
1587215|NCT03365934|2919200|Superiority|||||||0.965547|||||||t-test, 2 sided||||
1587216|NCT03365934|2919200|Superiority|||||||0.377217|||||||t-test, 2 sided||||
1587217|NCT03365934|2919200|Superiority|||||||0.00104|||||||t-test, 2 sided||||
1587218|NCT03365934|2919200|Superiority|||||||0.030267|||||||t-test, 2 sided||||
1587219|NCT03365934|2919200|Superiority|||||||0.834338|||||||t-test, 2 sided||||
1587220|NCT03365934|2919200|Superiority|||||||0.223341|||||||t-test, 2 sided||||
1587221|NCT03365934|2919200|Superiority|||||||0.995862|||||||t-test, 2 sided||||
1587222|NCT03365934|2919201|Superiority|||||||0.996358|||||||t-test, 2 sided||||
1587223|NCT03365934|2919201|Superiority|||||||0.013231|||||||t-test, 2 sided||||
1587224|NCT03365934|2919201|Superiority|||||||0.047937|||||||t-test, 2 sided||||
1587225|NCT03365934|2919201|Superiority|||||||0.163678|||||||t-test, 2 sided||||
1587226|NCT03365934|2919201|Superiority|||||||0.391295|||||||t-test, 2 sided||||
1587227|NCT03365934|2919201|Superiority|||||||0.886978|||||||t-test, 2 sided||||
1587234|NCT03365934|2919201|Superiority|||||||0.994384|||||||t-test, 2 sided||||
1587235|NCT03365934|2919201|Superiority|||||||0.526293|||||||t-test, 2 sided||||
1587236|NCT03365934|2919201|Superiority|||||||0.968005|||||||t-test, 2 sided||||
1587237|NCT03365934|2919202|Superiority|||||||0.965966|||||||t-test, 2 sided||||
1587238|NCT03365934|2919202|Superiority|||||||0.013135|||||||t-test, 2 sided||||
1587239|NCT03365934|2919202|Superiority|||||||0.112192|||||||t-test, 2 sided||||
1587240|NCT03365934|2919202|Superiority|||||||0.013468|||||||t-test, 2 sided||||
1587241|NCT03365934|2919202|Superiority|||||||0.119961|||||||t-test, 2 sided||||
1587242|NCT03365934|2919202|Superiority|||||||0.999999|||||||t-test, 2 sided||||
1587243|NCT03365934|2919202|Superiority|||||||0.001185|||||||t-test, 2 sided||||
1587244|NCT03365934|2919202|Superiority|||||||0.01764|||||||t-test, 2 sided||||
1587245|NCT03365934|2919202|Superiority|||||||0.98972|||||||t-test, 2 sided||||
1587246|NCT03365934|2919202|Superiority|||||||0.97816|||||||t-test, 2 sided||||
1587247|NCT03365934|2919202|Superiority|||||||0.000221|||||||t-test, 2 sided||||
1587248|NCT03365934|2919202|Superiority|||||||0.003915|||||||t-test, 2 sided||||
1587249|NCT03365934|2919202|Superiority|||||||0.855067|||||||t-test, 2 sided||||
1587250|NCT03365934|2919202|Superiority|||||||0.795279|||||||t-test, 2 sided||||
1587251|NCT03365934|2919202|Superiority|||||||0.99253|||||||t-test, 2 sided||||
1587252|NCT03365934|2919203|Superiority|||||||0.6094|||||||t-test, 2 sided||||
1587253|NCT03365934|2919203|Superiority|||||||0.930371|||||||t-test, 2 sided||||
1587254|NCT03365934|2919203|Superiority|||||||0.147361|||||||t-test, 2 sided||||
1587255|NCT03365934|2919203|Superiority|||||||0.987387|||||||t-test, 2 sided||||
1587256|NCT03365934|2919203|Superiority|||||||0.953645|||||||t-test, 2 sided||||
1587257|NCT03365934|2919203|Superiority|||||||0.647267|||||||t-test, 2 sided||||
1587258|NCT03365934|2919203|Superiority|||||||0.421603|||||||t-test, 2 sided||||
1587259|NCT03365934|2919203|Superiority|||||||0.008729|||||||t-test, 2 sided||||
1587260|NCT03365934|2919203|Superiority|||||||0.967277|||||||t-test, 2 sided||||
1587261|NCT03365934|2919203|Superiority|||||||0.15037|||||||t-test, 2 sided||||
1587262|NCT03365934|2919203|Superiority|||||||0.059485|||||||t-test, 2 sided||||
1587263|NCT03365934|2919203|Superiority|||||||0.000315|||||||t-test, 2 sided||||
1587264|NCT03365934|2919203|Superiority|||||||0.523284|||||||t-test, 2 sided||||
1587265|NCT03365934|2919203|Superiority|||||||0.013582|||||||t-test, 2 sided||||
1587266|NCT03365934|2919203|Superiority|||||||0.91874|||||||t-test, 2 sided||||
1587267|NCT03365934|2919204|Superiority|||||||0.999663|||||||t-test, 2 sided||||
1587268|NCT03365934|2919204|Superiority|||||||0.216229|||||||t-test, 2 sided||||
1587269|NCT03365934|2919204|Superiority|||||||0.112245|||||||t-test, 2 sided||||
1587270|NCT03365934|2919204|Superiority|||||||0.923224|||||||t-test, 2 sided||||
1587271|NCT03365934|2919204|Superiority|||||||0.790117|||||||t-test, 2 sided||||
1587272|NCT03365934|2919204|Superiority|||||||0.771698|||||||t-test, 2 sided||||
1587273|NCT03365934|2919204|Superiority|||||||0.034707|||||||t-test, 2 sided||||
1587274|NCT03365934|2919204|Superiority|||||||0.013025|||||||t-test, 2 sided||||
1587275|NCT03365934|2919204|Superiority|||||||0.990334|||||||t-test, 2 sided||||
1587276|NCT03365934|2919204|Superiority|||||||0.330576|||||||t-test, 2 sided||||
1587277|NCT03365934|2919204|Superiority|||||||0.017733|||||||t-test, 2 sided||||
1587278|NCT03365934|2919204|Superiority|||||||0.00622|||||||t-test, 2 sided||||
1587279|NCT03365934|2919204|Superiority|||||||0.958812|||||||t-test, 2 sided||||
1587280|NCT03365934|2919204|Superiority|||||||0.215132|||||||t-test, 2 sided||||
1587281|NCT03365934|2919204|Superiority|||||||0.999858|||||||t-test, 2 sided||||
1587282|NCT03365934|2919205|Superiority|||||||0.998744|||||||t-test, 2 sided||||
1587283|NCT03365934|2919205|Superiority|||||||0.999994|||||||t-test, 2 sided||||
1587284|NCT03365934|2919205|Superiority|||||||0.995849|||||||t-test, 2 sided||||
1587285|NCT03365934|2919205|Superiority|||||||0.111454|||||||t-test, 2 sided||||
1587286|NCT03365934|2919205|Superiority|||||||0.029675|||||||t-test, 2 sided||||
1587287|NCT03365934|2919205|Superiority|||||||0.219274|||||||t-test, 2 sided||||
1587288|NCT03365934|2919205|Superiority|||||||0.530181|||||||t-test, 2 sided||||
1587289|NCT03365934|2919205|Superiority|||||||0.257254|||||||t-test, 2 sided||||
1587290|NCT03365934|2919205|Superiority|||||||0.692455|||||||t-test, 2 sided||||
1587291|NCT03365934|2919205|Superiority|||||||0.951883|||||||t-test, 2 sided||||
1587292|NCT03365934|2919205|Superiority|||||||0.006615|||||||t-test, 2 sided||||
1587293|NCT03365934|2919205|Superiority|||||||0.000983|||||||t-test, 2 sided||||
1587294|NCT03365934|2919205|Superiority|||||||0.021978|||||||t-test, 2 sided||||
1587295|NCT03365934|2919205|Superiority|||||||0.890335|||||||t-test, 2 sided||||
1587296|NCT03365934|2919205|Superiority|||||||0.393119|||||||t-test, 2 sided||||
1587297|NCT03365934|2919206|Superiority|||||||0.383434|||||||t-test, 2 sided||||
1587298|NCT03365934|2919206|Superiority|||||||0.969093|||||||t-test, 2 sided||||
1587299|NCT03365934|2919206|Superiority|||||||0.894272|||||||t-test, 2 sided||||
1587300|NCT03365934|2919206|Superiority|||||||0.999996|||||||t-test, 2 sided||||
1587301|NCT03365934|2919206|Superiority|||||||0.313389|||||||t-test, 2 sided||||
1587302|NCT03365934|2919206|Superiority|||||||0.944307|||||||t-test, 2 sided||||
1587303|NCT03365934|2919206|Superiority|||||||0.815476|||||||t-test, 2 sided||||
1587304|NCT03365934|2919206|Superiority|||||||0.029518|||||||t-test, 2 sided||||
1587305|NCT03365934|2919206|Superiority|||||||0.380144|||||||t-test, 2 sided||||
1587306|NCT03365934|2919206|Superiority|||||||0.870124|||||||t-test, 2 sided||||
1587307|NCT03365934|2919206|Superiority|||||||0.275557|||||||t-test, 2 sided||||
1587308|NCT03365934|2919206|Superiority|||||||0.999971|||||||t-test, 2 sided||||
1587309|NCT03365934|2919206|Superiority|||||||0.812915|||||||t-test, 2 sided||||
1587310|NCT03365934|2919206|Superiority|||||||0.217862|||||||t-test, 2 sided||||
1587311|NCT03365934|2919206|Superiority|||||||0.016628|||||||t-test, 2 sided||||
1587312|NCT03365934|2919207|Superiority|||||||0.997565|||||||t-test, 2 sided||||
1587313|NCT03365934|2919207|Superiority|||||||0.070843|||||||t-test, 2 sided||||
1587314|NCT03365934|2919207|Superiority|||||||0.195527|||||||t-test, 2 sided||||
1587315|NCT03365934|2919207|Superiority|||||||0.277244|||||||t-test, 2 sided||||
1587316|NCT03365934|2919207|Superiority|||||||0.557877|||||||t-test, 2 sided||||
1587317|NCT03365934|2919207|Superiority|||||||0.974842|||||||t-test, 2 sided||||
1587318|NCT03365934|2919207|Superiority|||||||0.000235|||||||t-test, 2 sided||||
1587319|NCT03365934|2919207|Superiority|||||||0.001436|||||||t-test, 2 sided||||
1587320|NCT03365934|2919207|Superiority|||||||0.652654|||||||t-test, 2 sided||||
1587321|NCT03365934|2919207|Superiority|||||||0.168409|||||||t-test, 2 sided||||
1587322|NCT03365934|2919207|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587323|NCT03365934|2919207|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587324|NCT03365934|2919207|Superiority||||||<|0.085238|||||||t-test, 2 sided||||
1587325|NCT03365934|2919207|Superiority||||||<|0.00473|||||||t-test, 2 sided||||
1587326|NCT03365934|2919207|Superiority||||||<|0.862516|||||||t-test, 2 sided||||
1587327|NCT03365934|2919208|Superiority|||||||0.999897|||||||t-test, 2 sided||||
1587328|NCT03365934|2919208|Superiority|||||||0.257647|||||||t-test, 2 sided||||
1587329|NCT03365934|2919208|Superiority|||||||0.385419|||||||t-test, 2 sided||||
1587330|NCT03365934|2919208|Superiority|||||||0.277469|||||||t-test, 2 sided||||
1587331|NCT03365934|2919208|Superiority|||||||0.417914|||||||t-test, 2 sided||||
1587332|NCT03365934|2919208|Superiority|||||||0.999993|||||||t-test, 2 sided||||
1587333|NCT03365934|2919208|Superiority|||||||0.000728|||||||t-test, 2 sided||||
1587334|NCT03365934|2919208|Superiority|||||||0.002257|||||||t-test, 2 sided||||
1587335|NCT03365934|2919208|Superiority|||||||0.665529|||||||t-test, 2 sided||||
1587336|NCT03365934|2919208|Superiority|||||||0.512209|||||||t-test, 2 sided||||
1587337|NCT03365934|2919208|Superiority|||||||0.018334|||||||t-test, 2 sided||||
1587338|NCT03365934|2919208|Superiority|||||||0.038527|||||||t-test, 2 sided||||
1587339|NCT03365934|2919208|Superiority|||||||0.938|||||||t-test, 2 sided||||
1587340|NCT03365934|2919208|Superiority|||||||0.875832|||||||t-test, 2 sided||||
1587341|NCT03365934|2919208|Superiority|||||||0.996522|||||||t-test, 2 sided||||
1587342|NCT03365934|2919209|Superiority|||||||0.979516|||||||t-test, 2 sided||||
1587343|NCT03365934|2919209|Superiority|||||||0.06829|||||||t-test, 2 sided||||
1587344|NCT03365934|2919209|Superiority|||||||0.283848|||||||t-test, 2 sided||||
1587345|NCT03365934|2919209|Superiority|||||||0.239446|||||||t-test, 2 sided||||
1587346|NCT03365934|2919209|Superiority|||||||0.668933|||||||t-test, 2 sided||||
1587347|NCT03365934|2919209|Superiority|||||||0.974567|||||||t-test, 2 sided||||
1587348|NCT03365934|2919209|Superiority|||||||0.000113|||||||t-test, 2 sided||||
1587349|NCT03365934|2919209|Superiority|||||||0.001992|||||||t-test, 2 sided||||
1587350|NCT03365934|2919209|Superiority|||||||0.728796|||||||t-test, 2 sided||||
1587351|NCT03365934|2919209|Superiority|||||||0.175148|||||||t-test, 2 sided||||
1587352|NCT03365934|2919209|Superiority|||||||0.001099|||||||t-test, 2 sided||||
1587353|NCT03365934|2919209|Superiority|||||||0.010561|||||||t-test, 2 sided||||
1587354|NCT03365934|2919209|Superiority|||||||0.829352|||||||t-test, 2 sided||||
1587355|NCT03365934|2919209|Superiority|||||||0.317315|||||||t-test, 2 sided||||
1587356|NCT03365934|2919209|Superiority|||||||1|||||||t-test, 2 sided||||
1587357|NCT03365934|2919210|Superiority|||||||1|||||||t-test, 2 sided||||
1587358|NCT03365934|2919210|Superiority|||||||0.036131|||||||t-test, 2 sided||||
1587359|NCT03365934|2919210|Superiority|||||||0.041698|||||||t-test, 2 sided||||
1587360|NCT03365934|2919210|Superiority|||||||0.177549|||||||t-test, 2 sided||||
1587361|NCT03365934|2919210|Superiority|||||||0.19886|||||||t-test, 2 sided||||
1587362|NCT03365934|2919210|Superiority|||||||0.970029|||||||t-test, 2 sided||||
1587363|NCT03365934|2919210|Superiority|||||||0.001507|||||||t-test, 2 sided||||
1587364|NCT03365934|2919210|Superiority|||||||0.001845|||||||t-test, 2 sided||||
1587365|NCT03365934|2919210|Superiority|||||||0.984465|||||||t-test, 2 sided||||
1587366|NCT03365934|2919210|Superiority|||||||0.626878|||||||t-test, 2 sided||||
1587367|NCT03365934|2919210|Superiority|||||||0.000332|||||||t-test, 2 sided||||
1587368|NCT03365934|2919210|Superiority|||||||0.000412|||||||t-test, 2 sided||||
1587369|NCT03365934|2919210|Superiority|||||||0.883222|||||||t-test, 2 sided||||
1587370|NCT03365934|2919210|Superiority|||||||0.354187|||||||t-test, 2 sided||||
1587371|NCT03365934|2919210|Superiority|||||||0.997406|||||||t-test, 2 sided||||
1587372|NCT03365934|2919211|Superiority|||||||0.999993|||||||t-test, 2 sided||||
1587373|NCT03365934|2919211|Superiority|||||||0.034793|||||||t-test, 2 sided||||
1587374|NCT03365934|2919211|Superiority|||||||0.050132|||||||t-test, 2 sided||||
1587375|NCT03365934|2919211|Superiority|||||||0.054975|||||||t-test, 2 sided||||
1587376|NCT03365934|2919211|Superiority|||||||0.078046|||||||t-test, 2 sided||||
1587377|NCT03365934|2919211|Superiority|||||||0.999894|||||||t-test, 2 sided||||
1587378|NCT03365934|2919211|Superiority|||||||0.000133|||||||t-test, 2 sided||||
1587379|NCT03365934|2919211|Superiority|||||||0.000232|||||||t-test, 2 sided||||
1587380|NCT03365934|2919211|Superiority|||||||0.693868|||||||t-test, 2 sided||||
1587381|NCT03365934|2919211|Superiority|||||||0.511155|||||||t-test, 2 sided||||
1587382|NCT03365934|2919211|Superiority|||||||0.000115|||||||t-test, 2 sided||||
1587383|NCT03365934|2919211|Superiority|||||||0.000197|||||||t-test, 2 sided||||
1587384|NCT03365934|2919211|Superiority|||||||0.598141|||||||t-test, 2 sided||||
1587385|NCT03365934|2919211|Superiority|||||||0.421347|||||||t-test, 2 sided||||
1587386|NCT03365934|2919211|Superiority|||||||0.999952|||||||t-test, 2 sided||||
1587387|NCT03365934|2919212|Superiority|||||||0.616933|||||||t-test, 2 sided||||
1587388|NCT03365934|2919212|Superiority|||||||0.910989|||||||t-test, 2 sided||||
1587389|NCT03365934|2919212|Superiority|||||||0.130235|||||||t-test, 2 sided||||
1587390|NCT03365934|2919212|Superiority|||||||0.999998|||||||t-test, 2 sided||||
1587391|NCT03365934|2919212|Superiority|||||||0.726932|||||||t-test, 2 sided||||
1587392|NCT03365934|2919212|Superiority|||||||0.889597|||||||t-test, 2 sided||||
1587393|NCT03365934|2919212|Superiority|||||||0.034575|||||||t-test, 2 sided||||
1587394|NCT03365934|2919212|Superiority|||||||0.000112|||||||t-test, 2 sided||||
1587395|NCT03365934|2919212|Superiority|||||||0.465745|||||||t-test, 2 sided||||
1587396|NCT03365934|2919212|Superiority|||||||0.03731|||||||t-test, 2 sided||||
1587397|NCT03365934|2919212|Superiority|||||||0.014558|||||||t-test, 2 sided||||
1587398|NCT03365934|2919212|Superiority|||||||3.8e-05|||||||t-test, 2 sided||||
1587399|NCT03365934|2919212|Superiority|||||||0.289112|||||||t-test, 2 sided||||
1587400|NCT03365934|2919212|Superiority|||||||0.016246|||||||t-test, 2 sided||||
1587401|NCT03365934|2919212|Superiority|||||||0.99916|||||||t-test, 2 sided||||
1587402|NCT03365934|2919213|Superiority|||||||0.988693|||||||t-test, 2 sided||||
1587403|NCT03365934|2919213|Superiority|||||||0.626498|||||||t-test, 2 sided||||
1587404|NCT03365934|2919213|Superiority|||||||0.256079|||||||t-test, 2 sided||||
1587405|NCT03365934|2919213|Superiority|||||||0.928722|||||||t-test, 2 sided||||
1587406|NCT03365934|2919213|Superiority|||||||0.599171|||||||t-test, 2 sided||||
1587407|NCT03365934|2919213|Superiority|||||||0.988067|||||||t-test, 2 sided||||
1587408|NCT03365934|2919213|Superiority|||||||0.001612|||||||t-test, 2 sided||||
1587409|NCT03365934|2919213|Superiority|||||||0.000113|||||||t-test, 2 sided||||
1587410|NCT03365934|2919213|Superiority|||||||0.245375|||||||t-test, 2 sided||||
1587411|NCT03365934|2919213|Superiority|||||||0.039407|||||||t-test, 2 sided||||
1587412|NCT03365934|2919213|Superiority|||||||0.006871|||||||t-test, 2 sided||||
1587413|NCT03365934|2919213|Superiority|||||||0.00062|||||||t-test, 2 sided||||
1587414|NCT03365934|2919213|Superiority|||||||0.456846|||||||t-test, 2 sided||||
1587415|NCT03365934|2919213|Superiority|||||||0.111084|||||||t-test, 2 sided||||
1587416|NCT03365934|2919213|Superiority|||||||0.998949|||||||t-test, 2 sided||||
1587417|NCT03365934|2919214|Superiority|||||||0.99858|||||||t-test, 2 sided||||
1587418|NCT03365934|2919214|Superiority|||||||0.995238|||||||t-test, 2 sided||||
1587419|NCT03365934|2919214|Superiority|||||||0.942304|||||||t-test, 2 sided||||
1587420|NCT03365934|2919214|Superiority|||||||0.203418|||||||t-test, 2 sided||||
1587421|NCT03365934|2919214|Superiority|||||||0.062163|||||||t-test, 2 sided||||
1587422|NCT03365934|2919214|Superiority|||||||0.61046|||||||t-test, 2 sided||||
1587423|NCT03365934|2919214|Superiority|||||||0.350556|||||||t-test, 2 sided||||
1587424|NCT03365934|2919214|Superiority|||||||0.135805|||||||t-test, 2 sided||||
1587425|NCT03365934|2919214|Superiority|||||||0.773028|||||||t-test, 2 sided||||
1587426|NCT03365934|2919214|Superiority|||||||0.99809|||||||t-test, 2 sided||||
1587427|NCT03365934|2919214|Superiority|||||||0.038958|||||||t-test, 2 sided||||
1587428|NCT03365934|2919214|Superiority|||||||0.007591|||||||t-test, 2 sided||||
1587429|NCT03365934|2919214|Superiority|||||||0.233992|||||||t-test, 2 sided||||
1587430|NCT03365934|2919214|Superiority|||||||0.976812|||||||t-test, 2 sided||||
1587431|NCT03365934|2919214|Superiority|||||||0.92106|||||||t-test, 2 sided||||
1587432|NCT03365934|2919215|Superiority|||||||0.990516|||||||t-test, 2 sided||||
1587433|NCT03365934|2919215|Superiority|||||||0.999913|||||||t-test, 2 sided||||
1587434|NCT03365934|2919215|Superiority|||||||0.999324|||||||t-test, 2 sided||||
1587435|NCT03365934|2919215|Superiority|||||||0.999171|||||||t-test, 2 sided||||
1587436|NCT03365934|2919215|Superiority|||||||0.925553|||||||t-test, 2 sided||||
1587437|NCT03365934|2919215|Superiority|||||||0.99245|||||||t-test, 2 sided||||
1587438|NCT03365934|2919215|Superiority|||||||0.912495|||||||t-test, 2 sided||||
1587439|NCT03365934|2919215|Superiority|||||||0.592697|||||||t-test, 2 sided||||
1587440|NCT03365934|2919215|Superiority|||||||0.837995|||||||t-test, 2 sided||||
1587441|NCT03365934|2919215|Superiority|||||||0.985237|||||||t-test, 2 sided||||
1587442|NCT03365934|2919215|Superiority|||||||0.760706|||||||t-test, 2 sided||||
1587443|NCT03365934|2919215|Superiority|||||||0.975044|||||||t-test, 2 sided||||
1587444|NCT03365934|2919215|Superiority|||||||0.898749|||||||t-test, 2 sided||||
1587445|NCT03365934|2919215|Superiority|||||||0.526573|||||||t-test, 2 sided||||
1587446|NCT03365934|2919215|Superiority|||||||0.193667|||||||t-test, 2 sided||||
1587447|NCT03365934|2919216|Superiority|||||||0.999621|||||||t-test, 2 sided||||
1587448|NCT03365934|2919216|Superiority|||||||0.999851|||||||t-test, 2 sided||||
1587449|NCT03365934|2919216|Superiority|||||||0.994413|||||||t-test, 2 sided||||
1587450|NCT03365934|2919216|Superiority|||||||0.197791|||||||t-test, 2 sided||||
1587451|NCT03365934|2919216|Superiority|||||||0.104388|||||||t-test, 2 sided||||
1587452|NCT03365934|2919216|Superiority|||||||0.412626|||||||t-test, 2 sided||||
1587453|NCT03365934|2919216|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587454|NCT03365934|2919216|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587455|NCT03365934|2919216|Superiority||||||<|0.000211|||||||t-test, 2 sided||||
1587456|NCT03365934|2919216|Superiority||||||<|0.061015|||||||t-test, 2 sided||||
1587457|NCT03365934|2919216|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587458|NCT03365934|2919216|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587459|NCT03365934|2919216|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587460|NCT03365934|2919216|Superiority||||||<|0.002376|||||||t-test, 2 sided||||
1587461|NCT03365934|2919216|Superiority||||||<|0.943522|||||||t-test, 2 sided||||
1587462|NCT03365934|2919217|Superiority|||||||1|||||||t-test, 2 sided||||
1587463|NCT03365934|2919217|Superiority|||||||0.803277|||||||t-test, 1 sided||||
1587464|NCT03365934|2919217|Superiority|||||||0.832757|||||||t-test, 2 sided||||
1587465|NCT03365934|2919217|Superiority|||||||0.630145|||||||t-test, 2 sided||||
1587466|NCT03365934|2919217|Superiority|||||||0.672573|||||||t-test, 2 sided||||
1587467|NCT03365934|2919217|Superiority|||||||0.999957|||||||t-test, 2 sided||||
1587468|NCT03365934|2919217|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587469|NCT03365934|2919217|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587470|NCT03365934|2919217|Superiority||||||<|0.001916|||||||t-test, 2 sided||||
1587471|NCT03365934|2919217|Superiority||||||<|0.002026|||||||t-test, 2 sided||||
1587472|NCT03365934|2919217|Superiority||||||<|0.140475|||||||t-test, 2 sided||||
1587473|NCT03365934|2919217|Superiority||||||<|0.165225|||||||t-test, 2 sided||||
1587474|NCT03365934|2919217|Superiority||||||<|0.893545|||||||t-test, 2 sided||||
1587475|NCT03365934|2919217|Superiority||||||<|0.942653|||||||t-test, 2 sided||||
1587476|NCT03365934|2919217|Superiority||||||<|0.066788|||||||t-test, 2 sided||||
1587477|NCT03365934|2919218|Superiority|||||||0.999531|||||||t-test, 2 sided||||
1587478|NCT03365934|2919218|Superiority|||||||0.341884|||||||t-test, 2 sided||||
1587479|NCT03365934|2919218|Superiority|||||||0.208803|||||||t-test, 2 sided||||
1587480|NCT03365934|2919218|Superiority|||||||0.007492|||||||t-test, 2 sided||||
1587481|NCT03365934|2919218|Superiority|||||||0.002821|||||||t-test, 2 sided||||
1587482|NCT03365934|2919218|Superiority|||||||0.859272|||||||t-test, 2 sided||||
1587483|NCT03365934|2919218|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587484|NCT03365934|2919218|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587485|NCT03365934|2919218|Superiority||||||<|5.9e-05|||||||t-test, 2 sided||||
1587486|NCT03365934|2919218|Superiority||||||<|0.001356|||||||t-test, 2 sided||||
1587487|NCT03365934|2919218|Superiority||||||<|0.028517|||||||t-test, 2 sided||||
1587488|NCT03365934|2919218|Superiority||||||<|0.013004|||||||t-test, 2 sided||||
1587489|NCT03365934|2919218|Superiority||||||<|0.914409|||||||t-test, 2 sided||||
1587490|NCT03365934|2919218|Superiority||||||<|1|||||||t-test, 2 sided||||
1587491|NCT03365934|2919218|Superiority||||||<|0.00526|||||||t-test, 2 sided||||
1587492|NCT03365934|2919219|Superiority|||||||0.963882|||||||t-test, 2 sided||||
1587493|NCT03365934|2919219|Superiority|||||||0.089156|||||||t-test, 2 sided||||
1587494|NCT03365934|2919219|Superiority|||||||0.011015|||||||t-test, 2 sided||||
1587495|NCT03365934|2919219|Superiority|||||||0.28061|||||||t-test, 2 sided||||
1587496|NCT03365934|2919219|Superiority|||||||0.046422|||||||t-test, 2 sided||||
1587497|NCT03365934|2919219|Superiority|||||||0.985602|||||||t-test, 2 sided||||
1587498|NCT03365934|2919219|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587499|NCT03365934|2919219|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587500|NCT03365934|2919219|Superiority||||||<|0.051717|||||||t-test, 2 sided||||
1587501|NCT03365934|2919219|Superiority||||||<|0.002997|||||||t-test, 2 sided||||
1587502|NCT03365934|2919219|Superiority||||||<|0.000843|||||||t-test, 2 sided||||
1587503|NCT03365934|2919219|Superiority||||||<|3.5e-05|||||||t-test, 2 sided||||
1587504|NCT03365934|2919219|Superiority||||||<|0.834145|||||||t-test, 2 sided||||
1587505|NCT03365934|2919219|Superiority||||||<|0.358412|||||||t-test, 2 sided||||
1587506|NCT03365934|2919219|Superiority||||||<|0.516068|||||||t-test, 2 sided||||
1587507|NCT03365934|2919220|Superiority|||||||0.987798|||||||t-test, 2 sided||||
1587508|NCT03365934|2919220|Superiority|||||||0.253458|||||||t-test, 2 sided||||
1587509|NCT03365934|2919220|Superiority|||||||0.062829|||||||t-test, 2 sided||||
1587510|NCT03365934|2919220|Superiority|||||||0.184508|||||||t-test, 2 sided||||
1587511|NCT03365934|2919220|Superiority|||||||0.038836|||||||t-test, 2 sided||||
1587512|NCT03365934|2919220|Superiority|||||||0.999999|||||||t-test, 2 sided||||
1587513|NCT03365934|2919220|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587514|NCT03365934|2919220|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587515|NCT03365934|2919220|Superiority||||||<|0.001825|||||||t-test, 2 sided||||
1587516|NCT03365934|2919220|Superiority||||||<|0.001817|||||||t-test, 2 sided||||
1587517|NCT03365934|2919220|Superiority||||||<|3.03e-05|||||||t-test, 2 sided||||
1587518|NCT03365934|2919220|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587519|NCT03365934|2919220|Superiority||||||<|0.081846|||||||t-test, 2 sided||||
1587520|NCT03365934|2919220|Superiority||||||<|0.088558|||||||t-test, 2 sided||||
1587521|NCT03365934|2919220|Superiority||||||<|0.882449|||||||t-test, 2 sided||||
1587522|NCT03365934|2919221|Superiority|||||||0.570015|||||||t-test, 2 sided||||
1587523|NCT03365934|2919221|Superiority|||||||0.900265|||||||t-test, 2 sided||||
1587524|NCT03365934|2919221|Superiority|||||||0.103828|||||||t-test, 2 sided||||
1587525|NCT03365934|2919221|Superiority|||||||0.870163|||||||t-test, 2 sided||||
1587526|NCT03365934|2919221|Superiority|||||||0.0792013|||||||t-test, 2 sided||||
1587527|NCT03365934|2919221|Superiority|||||||0.99999995|||||||t-test, 2 sided||||
1587528|NCT03365934|2919221|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587529|NCT03365934|2919221|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587530|NCT03365934|2919221|Superiority||||||<|2.12e-05|||||||t-test, 2 sided||||
1587531|NCT03365934|2919221|Superiority||||||<|1.67e-05|||||||t-test, 2 sided||||
1587532|NCT03365934|2919221|Superiority||||||<|0.0133001|||||||t-test, 2 sided||||
1587533|NCT03365934|2919221|Superiority||||||<|2.47e-05|||||||t-test, 2 sided||||
1587534|NCT03365934|2919221|Superiority||||||<|0.290551|||||||t-test, 2 sided||||
1587535|NCT03365934|2919221|Superiority||||||<|0.2953049|||||||t-test, 2 sided||||
1587536|NCT03365934|2919221|Superiority||||||<|0.0403539|||||||t-test, 2 sided||||
1587537|NCT03365934|2919222|Superiority|||||||0.8562779|||||||t-test, 2 sided||||
1587538|NCT03365934|2919222|Superiority|||||||0.9992002|||||||t-test, 2 sided||||
1587539|NCT03365934|2919222|Superiority|||||||0.6845362|||||||t-test, 2 sided||||
1587540|NCT03365934|2919222|Superiority|||||||0.9802252|||||||t-test, 2 sided||||
1587541|NCT03365934|2919222|Superiority|||||||0.4205363|||||||t-test, 2 sided||||
1587542|NCT03365934|2919222|Superiority|||||||0.999533|||||||t-test, 2 sided||||
1587543|NCT03365934|2919222|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587544|NCT03365934|2919222|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587545|NCT03365934|2919222|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587546|NCT03365934|2919222|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1587547|NCT03365934|2919222|Superiority||||||<|0.010829|||||||t-test, 2 sided||||
1587548|NCT03365934|2919222|Superiority||||||<|0.000126|||||||t-test, 2 sided||||
1587549|NCT03365934|2919222|Superiority||||||<|0.049247|||||||t-test, 2 sided||||
1587550|NCT03365934|2919222|Superiority||||||<|0.08431|||||||t-test, 2 sided||||
1587551|NCT03365934|2919222|Superiority||||||<|0.027774|||||||t-test, 2 sided||||
1587552|NCT03365934|2919223|Superiority|||||||0.97621|||||||t-test, 2 sided||||
1587553|NCT03365934|2919223|Superiority|||||||0.753883|||||||t-test, 2 sided||||
1587554|NCT03365934|2919223|Superiority|||||||0.300536|||||||t-test, 2 sided||||
1587555|NCT03365934|2919223|Superiority|||||||0.0651|||||||t-test, 2 sided||||
1587556|NCT03365934|2919223|Superiority|||||||0.004322|||||||t-test, 2 sided||||
1587557|NCT03365934|2919223|Superiority|||||||0.854566|||||||t-test, 2 sided||||
1587558|NCT03365934|2919223|Superiority|||||||0.0146|||||||t-test, 2 sided||||
1587559|NCT03365934|2919223|Superiority|||||||0.000649|||||||t-test, 2 sided||||
1587560|NCT03365934|2919223|Superiority|||||||0.545378|||||||t-test, 2 sided||||
1587561|NCT03365934|2919223|Superiority|||||||0.988995|||||||t-test, 2 sided||||
1587562|NCT03365934|2919223|Superiority|||||||0.071935|||||||t-test, 2 sided||||
1587563|NCT03365934|2919223|Superiority|||||||0.004963|||||||t-test, 2 sided||||
1587564|NCT03365934|2919223|Superiority|||||||0.870459|||||||t-test, 2 sided||||
1587565|NCT03365934|2919223|Superiority|||||||1|||||||t-test, 2 sided||||
1587566|NCT03365934|2919223|Superiority|||||||0.985332|||||||t-test, 2 sided||||
1587567|NCT03365934|2919224|Superiority|||||||0.999518|||||||t-test, 2 sided||||
1587568|NCT03365934|2919224|Superiority|||||||0.997568|||||||t-test, 2 sided||||
1587569|NCT03365934|2919224|Superiority|||||||0.999989|||||||t-test, 2 sided||||
1587570|NCT03365934|2919224|Superiority|||||||0.704759|||||||t-test, 2 sided||||
1587571|NCT03365934|2919224|Superiority|||||||0.86475|||||||t-test, 2 sided||||
1587572|NCT03365934|2919224|Superiority|||||||0.939549|||||||t-test, 2 sided||||
1587573|NCT03365934|2919224|Superiority|||||||0.607134|||||||t-test, 2 sided||||
1587574|NCT03365934|2919224|Superiority|||||||0.782208|||||||t-test, 2 sided||||
1587575|NCT03365934|2919224|Superiority|||||||0.883479|||||||t-test, 2 sided||||
1587576|NCT03365934|2919224|Superiority|||||||0.999941|||||||t-test, 2 sided||||
1587577|NCT03365934|2919224|Superiority|||||||0.842476|||||||t-test, 2 sided||||
1587578|NCT03365934|2919224|Superiority|||||||0.639911|||||||t-test, 2 sided||||
1587579|NCT03365934|2919224|Superiority|||||||0.601716|||||||t-test, 2 sided||||
1587580|NCT03365934|2919224|Superiority|||||||0.092027|||||||t-test, 2 sided||||
1587581|NCT03365934|2919224|Superiority|||||||0.071225|||||||t-test, 2 sided||||
1587582|NCT03364335|2919234|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.1045|||||||ANCOVA||||
1587583|NCT03364335|2919234|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.005|||||||ANCOVA||||
1587584|NCT03364335|2919234|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.3827|||||||ANCOVA||||
1587585|NCT03364335|2919234|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline hsCRP as the covariate. Treatment A is used as the reference group.||||||0.0318|||||||ANCOVA||||
1587586|NCT03364335|2919235|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.3721|||||||ANCOVA||||
1587587|NCT03364335|2919235|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.6991|||||||ANCOVA||||
1587588|NCT03364335|2919235|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.4411|||||||ANCOVA||||
1587589|NCT03364335|2919235|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline systolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.1843|||||||ANCOVA||||
1587590|NCT03364335|2919236|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.5426|||||||ANCOVA||||
1587591|NCT03364335|2919236|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.3702|||||||ANCOVA||||
1587642|NCT03350724|2919467|Superiority|||||||0.375||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value|||
1587592|NCT03364335|2919236|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.5221|||||||ANCOVA||||
1587593|NCT03364335|2919236|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline diastolic blood pressure as the covariate. Treatment A is used as the reference group.||||||0.0524|||||||ANCOVA||||
1587594|NCT03364335|2919237|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.1583|||||||ANCOVA||||
1587595|NCT03364335|2919237|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.0608|||||||ANCOVA||||
1587596|NCT03364335|2919237|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.197|||||||ANCOVA||||
1587597|NCT03364335|2919237|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline HbA1c as the covariate. Treatment A is used as the reference group.||||||0.1653|||||||ANCOVA||||
1587598|NCT03364335|2919238|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.3676|||||||ANCOVA||||
1587599|NCT03364335|2919238|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.5485|||||||ANCOVA||||
1587600|NCT03364335|2919238|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.7934|||||||ANCOVA||||
1587601|NCT03364335|2919238|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline Fasting Plasma Glucose as the covariate. Treatment A is used as the reference group.||||||0.6726|||||||ANCOVA||||
1587602|NCT03364335|2919239|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4295|||||||ANCOVA||||
1587603|NCT03364335|2919239|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.1377|||||||ANCOVA||||
1587604|NCT03364335|2919239|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.2302|||||||ANCOVA||||
1587605|NCT03364335|2919239|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.372|||||||ANCOVA||||
1587606|NCT03364335|2919240|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.0341|||||||ANCOVA||||
1587607|NCT03364335|2919240|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6317|||||||ANCOVA||||
1587608|NCT03364335|2919240|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8971|||||||ANCOVA||||
1587609|NCT03364335|2919240|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6574|||||||ANCOVA||||
1587610|NCT03364335|2919241|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.9223|||||||ANCOVA||||
1587611|NCT03364335|2919241|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8167|||||||ANCOVA||||
1587612|NCT03364335|2919241|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.8573|||||||ANCOVA||||
1587613|NCT03364335|2919241|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4644|||||||ANCOVA||||
1587614|NCT03364335|2919242|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.031|||||||ANCOVA||||
1587615|NCT03364335|2919242|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.4354|||||||ANCOVA||||
1587616|NCT03364335|2919242|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.6513|||||||ANCOVA||||
1587617|NCT03364335|2919242|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline fasting plasma lipid as the covariate. Treatment A is used as the reference group.||||||0.601|||||||ANCOVA||||
1587618|NCT03364335|2919243|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.5937|||||||ANCOVA||||
1587619|NCT03364335|2919243|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.1276|||||||ANCOVA||||
1587643|NCT03350724|2919468|Superiority|||||||0.967||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value|||
1588152|NCT03343080|2919709|Superiority|||||||0.776|||||||Wilcoxon (Mann-Whitney)||||
1587620|NCT03364335|2919243|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.4254|||||||ANCOVA||||
1587621|NCT03364335|2919243|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline waist circumference as the covariate. Treatment A is used as the reference group.||||||0.9656|||||||ANCOVA||||
1587622|NCT03364335|2919244|Other|Pearson’s Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.6758|||||||Chi-squared||||
1587623|NCT03364335|2919244|Other|Pearson’s Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.0749|||||||Chi-squared||||
1587624|NCT03364335|2919244|Other|Pearson’s Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||0.2646|||||||Chi-squared||||
1587625|NCT03364335|2919244|Other|Pearson’s Chi Square Test is used. Fisher exact test is used when any expected cell count is less than 5. Treatment A is used as the reference group.||||||1|||||||Chi-squared||||
1587626|NCT03364335|2919245|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0464|||||||ANCOVA||||
1587627|NCT03364335|2919245|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0215|||||||ANCOVA||||
1587628|NCT03364335|2919245|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0379|||||||ANCOVA||||
1587629|NCT03364335|2919245|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.5348|||||||ANCOVA||||
1587630|NCT03364335|2919246|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0349|||||||ANCOVA||||
1587631|NCT03364335|2919246|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0156|||||||ANCOVA||||
1587632|NCT03364335|2919246|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.0364|||||||ANCOVA||||
1587633|NCT03364335|2919246|Other|Analysis of covariance (ANCOVA) model: with treatment group and time as the main effects and baseline body weight as the covariate. Treatment A is used as the reference group.||||||0.5461|||||||ANCOVA||||
1587634|NCT03363906|2919247|Superiority||Mean Difference (Final Values)|1.14||||0.119|2-Sided|90.0|0.993|1.3|||ANOVA||||
1587635|NCT03363906|2919248|Superiority||Ratio Geometric Least Squares (LS) Mean|1.04||||0.473|2-Sided|90.0|0.949|1.14|||Mixed Models Analysis||||
1587636|NCT03354663|2919372|Other|"The hypothesis is formally expressed as:~H0: P < 90% Ha: P ≥ 90%, where P is the percentage of subjects with acute success. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level. Rejection of the null hypothesis will indicate study success."|Proportion|0.98||||0.0001|1-Sided|95.0|0.9495||||Binomial Exact Test||||
1587637|NCT03354663|2919373|Other|Single arm trial|Proportion|0.047|||<|0.0001|1-Sided|95.0||0.0864|||Binomial Exact Test|||"The hypothesis is formally expressed as:~H0: P ≥ 16.2% Ha: P < 16.2%, where P is the percentage of subjects with a primary safety endpoint event. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level."|
1587638|NCT03351699|2919435|Superiority|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.75|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 96%.||
1587639|NCT03351699|2919435|Superiority|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.52|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 75%.||
1587640|NCT03351699|2919435|Superiority|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.73|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 95%.||
1587641|NCT03351699|2919435|Superiority|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|Posterior Mean Difference|-1.53|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-4250 and placebo at least 1.4 log10 copies/mL was 78%.||
1599043|NCT02858401|2938154|Other|||||||1|||||||Fisher Exact||||
1587644|NCT03350724|2919469|Superiority|||||||0.64||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value|||
1587645|NCT03350724|2919470|Superiority|||||||0.882||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value|||
1587646|NCT03350724|2919471|Superiority|||||||0.22||||||Unadjusted p-value|Paired t-Test|Unadjusted p-value|||
1587647|NCT03350724|2919472|Superiority|||||||0.357||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value|||
1587648|NCT03350724|2919473|Superiority|||||||0.421||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value|||
1587649|NCT03350724|2919474|Superiority|||||||0.941||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value|||
1587650|NCT03350724|2919475|Superiority|||||||0.765||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value|||
1587651|NCT03350724|2919476|Superiority|||||||0.444||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value|||
1587652|NCT03350724|2919477|Superiority|||||||0.035||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value|||
1587653|NCT03350724|2919478|Superiority|||||||0.021||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value|||
1587654|NCT03350724|2919479|Superiority|||||||0.015||||||Unadjusted p-value|Wilcoxon (Mann-Whitney)|Unadjusted p-value|||
1587655|NCT03350724|2919480|Superiority|||||||0.999||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value|||
1587656|NCT03350724|2919481|Superiority|||||||0.308||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value|||
1587657|NCT03350724|2919482|Superiority|||||||0.368||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value|||
1587658|NCT03350724|2919483|Superiority|||||||0.484||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value|||
1587659|NCT03350724|2919484|Superiority|||||||0.171||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value|||
1587660|NCT03350724|2919485|Superiority|||||||0.032|||||||Z-Test for Two Population Proportions||||
1587661|NCT03350724|2919486|Superiority|||||||0.037||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value|||
1587662|NCT03350724|2919487|Superiority|||||||0.039||||||Unadjusted p-value|Z-Test for Two Population Proportions|Unadjusted p-value|||
1587663|NCT03349437|2919521|Superiority|||||||0.02||||||This p-value is in reference to the total Modified 6MWT Distance|Wilcoxon Signed Rank||||
1587664|NCT03349060|2919544|Superiority||Difference in LS mean|3.0||||0.0275|2-Sided|95.0|0.3|5.8||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA||||
1587665|NCT03349060|2919544|Superiority||Difference in LS mean|1.7||||0.2256|2-Sided|95.0|-1.0|4.4||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA||||
1587666|NCT03349060|2919545|Superiority||Difference in LS mean|4.7|||<|0.0001|2-Sided|95.0|2.4|7.0||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA||||
1587667|NCT03349060|2919545|Superiority||Difference in LS mean|3.8|||<|0.0013|2-Sided|95.0|1.5|6.1||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA||||
1587668|NCT03349060|2919546|Superiority||Difference in LS mean|0.9||||0.5821|2-Sided|95.0|-2.3|4.1||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA||||
1587669|NCT03349060|2919546|Superiority||Difference in LS mean|1.0||||0.5241|2-Sided|95.0|-2.1|4.2||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA||||
1587670|NCT03349060|2919547|Superiority||Difference in LS mean|4.5||||0.0013|2-Sided|95.0|1.8|7.3||ANCOVA model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA||||
1587671|NCT03349060|2919547|Superiority||Difference in LS mean|3.6||||0.0102|2-Sided|95.0|0.9|6.4||Analysis of covariance (ANCOVA) model was used including treatment as main effect and randomization strata (baseline disease severity and age category) and baseline value as covariates.|ANCOVA||||
1587672|NCT03349060|2919548|Superiority||Difference in LS mean|12.948||||0.0064|2-Sided|95.0|3.754|22.143|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587673|NCT03349060|2919548|Superiority||Difference in LS mean|6.071||||0.1915|2-Sided|95.0|-3.107|15.249|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587674|NCT03349060|2919548|Superiority||Difference in LS mean|9.354||||0.1009|2-Sided|95.0|-1.866|20.573|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587675|NCT03349060|2919548|Superiority||Difference in LS mean|8.672||||0.1267|2-Sided|95.0|-2.518|19.862|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587676|NCT03349060|2919548|Superiority||Difference in LS mean|16.99||||0.0015|2-Sided|95.0|6.699|27.281|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587677|NCT03349060|2919548|Superiority||Difference in LS mean|6.853||||0.1894|2-Sided|95.0|-3.453|17.159|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587678|NCT03349060|2919548|Superiority||Difference in LS mean|11.549||||0.0147|2-Sided|95.0|2.338|20.761|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587679|NCT03349060|2919548|Superiority||Difference in LS mean|2.131||||0.6467|2-Sided|95.0|-7.095|11.358|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587680|NCT03349060|2919549|Superiority||Difference in LS mean|0.062||||0.5212|2-Sided|95.0|-0.13|0.254|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587681|NCT03349060|2919549|Superiority||Difference in LS mean|0.007||||0.9429|2-Sided|95.0|-0.184|0.198|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587682|NCT03349060|2919549|Superiority||Difference in LS mean|0.08||||0.4016|2-Sided|95.0|-0.109|0.27|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587683|NCT03349060|2919549|Superiority||Difference in LS mean|0.004||||0.9638|2-Sided|95.0|-0.185|0.194|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587684|NCT03349060|2919549|Superiority||Difference in LS mean|0.284||||0.0015|2-Sided|95.0|0.112|0.456|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587685|NCT03349060|2919549|Superiority||Difference in LS mean|0.174||||0.0491|2-Sided|95.0|0.001|0.347|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587686|NCT03349060|2919549|Superiority||Difference in LS mean|0.09||||0.1782|2-Sided|95.0|-0.042|0.223|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587687|NCT03349060|2919549|Superiority||Difference in LS mean|-0.004||||0.9568|2-Sided|95.0|-0.137|0.13|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587688|NCT03349060|2919550|Superiority||Difference in LS mean|9.374||||0.0008|2-Sided|95.0|3.933|14.815|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587689|NCT03349060|2919550|Superiority||Difference in LS mean|7.569||||0.0067|2-Sided|95.0|2.119|13.019|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587690|NCT03349060|2919550|Superiority||Difference in LS mean|9.803||||0.0005|2-Sided|95.0|4.368|15.237|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587691|NCT03349060|2919550|Superiority||Difference in LS mean|6.045||||0.03|2-Sided|95.0|0.589|11.501|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587692|NCT03349060|2919550|Superiority||Difference in LS mean|10.085|||<|0.0001|2-Sided|95.0|5.349|14.821|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587693|NCT03349060|2919550|Superiority||Difference in LS mean|4.361|||<|0.0702|2-Sided|95.0|-0.362|9.084|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587694|NCT03349060|2919550|Superiority||Difference in LS mean|8.659|||<|0.0001|2-Sided|95.0|4.496|12.822|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587695|NCT03349060|2919550|Superiority||Difference in LS mean|4.548|||<|0.0319|2-Sided|95.0|0.397|8.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587696|NCT03349060|2919551|Superiority||Difference in LS mean|0.064||||0.0037|2-Sided|95.0|0.021|0.107|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587697|NCT03349060|2919551|Superiority||Difference in LS mean|0.044||||0.0461|2-Sided|95.0|0.001|0.087|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587997|NCT03346070|2919634|Superiority||Difference in percentage|4.4|||||2-Sided|95.0|-9.6|19.2|||||Miettinen and Nurminen method||
1587698|NCT03349060|2919551|Superiority||Difference in LS mean|0.093|||<|0.0001|2-Sided|95.0|0.051|0.134|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587699|NCT03349060|2919551|Superiority||Difference in LS mean|0.048|||<|0.0241|2-Sided|95.0|0.006|0.09|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587700|NCT03349060|2919551|Superiority||Difference in LS mean|0.055|||<|0.0038|2-Sided|95.0|0.018|0.092|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587701|NCT03349060|2919551|Superiority||Difference in LS mean|0.025|||<|0.1821|2-Sided|95.0|-0.012|0.062|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587702|NCT03349060|2919551|Superiority||Difference in LS mean|0.068|||<|0.0001|2-Sided|95.0|0.036|0.101|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587703|NCT03349060|2919551|Superiority||Difference in LS mean|0.034|||<|0.0453|2-Sided|95.0|0.001|0.066|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587704|NCT03349060|2919552|Superiority||Difference in Percentage|29.3|||<|0.0001|2-Sided|95.0|19.6|38.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587705|NCT03349060|2919552|Superiority||Difference in Percentage|14.2|||<|0.0075|2-Sided|95.0|5.3|23.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587706|NCT03349060|2919552|Superiority||Difference in Percentage|26.2|||<|0.0001|2-Sided|95.0|16.2|36.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587707|NCT03349060|2919552|Superiority||Difference in Percentage|8.9|||<|0.0781|2-Sided|95.0|-0.1|18.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587708|NCT03349060|2919552|Superiority||Difference in Percentage|26.2|||<|0.0001|2-Sided|95.0|16.9|35.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587709|NCT03349060|2919552|Superiority||Difference in Percentage|9.2|||<|0.0411|2-Sided|95.0|1.3|17.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587710|NCT03349060|2919552|Superiority||Difference in Percentage|18.1|||<|0.0002|2-Sided|95.0|10.7|25.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587711|NCT03349060|2919552|Superiority||Difference in Percentage|6.0|||<|0.0575|2-Sided|95.0|0.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587712|NCT03349060|2919553|Superiority||Difference in LS mean|-0.9|||<|0.0001|2-Sided|95.0|-1.3|-0.6|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587713|NCT03349060|2919553|Superiority||Difference in LS mean|-0.5|||<|0.0014|2-Sided|95.0|-0.8|-0.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587714|NCT03349060|2919553|Superiority||Difference in LS mean|-0.9|||<|0.0001|2-Sided|95.0|-1.2|-0.6|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587715|NCT03349060|2919553|Superiority||Difference in LS mean|-0.5|||<|0.002|2-Sided|95.0|-0.8|-0.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587716|NCT03349060|2919553|Superiority||Difference in LS mean|-1.0|||<|0.0001|2-Sided|95.0|-1.2|-0.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1589900|NCT03233308|2923207|Other||||||<|0.0001|||||||t-test, 1 sided|||Mean change from baseline -IOP|
1587717|NCT03349060|2919553|Superiority||Difference in LS mean|-0.5|||<|0.0011|2-Sided|95.0|-0.7|-0.2|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587718|NCT03349060|2919553|Superiority||Difference in LS mean|-0.8|||<|0.0001|2-Sided|95.0|-1.0|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587719|NCT03349060|2919553|Superiority||Difference in LS mean|-0.4|||<|0.002|2-Sided|95.0|-0.6|-0.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587720|NCT03349060|2919554|Superiority||Difference in LS mean|-6.9|||<|0.0001|2-Sided|95.0|-9.0|-4.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587721|NCT03349060|2919554|Superiority||Difference in LS mean|-3.1|||<|0.0049|2-Sided|95.0|-5.2|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587722|NCT03349060|2919554|Superiority||Difference in LS mean|-7.2|||<|0.0001|2-Sided|95.0|-9.3|-5.2|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587723|NCT03349060|2919554|Superiority||Difference in LS mean|-2.7|||<|0.0096|2-Sided|95.0|-4.7|-0.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587724|NCT03349060|2919554|Superiority||Difference in LS mean|-8.4|||<|0.0001|2-Sided|95.0|-10.2|-6.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587725|NCT03349060|2919554|Superiority||Difference in LS mean|-3.8|||<|0.0001|2-Sided|95.0|-5.6|-2.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587726|NCT03349060|2919554|Superiority||Difference in LS mean|-6.3|||<|0.0001|2-Sided|95.0|-7.9|-4.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587727|NCT03349060|2919554|Superiority||Difference in LS mean|-2.8|||<|0.0006|2-Sided|95.0|-4.4|-1.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587728|NCT03349060|2919555|Superiority||Difference in Percentage|24.6||||0.3173|2-Sided|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587729|NCT03349060|2919555|Superiority||Difference in Percentage|-25.0||||0.5408|2-Sided|95.0|-77.0|27.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587730|NCT03349060|2919555|Superiority||Difference in Percentage|24.6||||0.3173|2-Sided|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587731|NCT03349060|2919555|Superiority||Difference in Percentage|-25.0||||0.5408|2-Sided|95.0|-77.0|27.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587732|NCT03349060|2919555|Superiority||Difference in Percentage|24.6||||0.3173|2-Sided|95.0|-14.4|63.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587733|NCT03349060|2919555|Superiority||Difference in Percentage|-3.6||||0.9219|2-Sided|95.0|-55.6|48.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587734|NCT03349060|2919555|Superiority||Difference in Percentage|-27.9||||0.3573|2-Sided|95.0|-62.5|6.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587735|NCT03349060|2919555|Superiority||Difference in Percentage|-78.6||||0.0546|2-Sided|95.0|-117.5|-39.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587736|NCT03349060|2919556|Superiority||Difference in Percentage|4.2||||0.8647|2-Sided|95.0|-36.3|44.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587737|NCT03349060|2919556|Superiority||Difference in Percentage|11.9||||0.5982|2-Sided|95.0|-29.1|53.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587738|NCT03349060|2919556|Superiority||Difference in Percentage|-30.7||||0.2092|2-Sided|95.0|-70.9|9.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587739|NCT03349060|2919556|Superiority||Difference in Percentage|-18.8||||0.4036|2-Sided|95.0|-58.4|20.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587740|NCT03349060|2919556|Superiority||Difference in Percentage|-19.8||||0.4149|2-Sided|95.0|-63.3|23.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587741|NCT03349060|2919556|Superiority||Difference in Percentage|-14.2||||0.514|2-Sided|95.0|-53.5|25.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587742|NCT03349060|2919556|Superiority||Difference in Percentage|-35.3||||0.158|2-Sided|95.0|-75.9|5.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587743|NCT03349060|2919556|Superiority||Difference in Percentage|-18.8||||0.4036|2-Sided|95.0|-58.4|20.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587744|NCT03349060|2919557|Superiority||Difference in Percentage|40.5||||0.055|2-Sided|95.0|2.4|78.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587745|NCT03349060|2919557|Superiority||Difference in Percentage|18.2||||0.3638|2-Sided|95.0|-18.7|55.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587746|NCT03349060|2919557|Superiority||Difference in Percentage|8.7||||0.6585|2-Sided|95.0|-27.3|44.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587747|NCT03349060|2919557|Superiority||Difference in Percentage|-6.7||||0.729|2-Sided|95.0|-40.7|27.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587748|NCT03349060|2919557|Superiority||Difference in Percentage|16.9||||0.4139|2-Sided|95.0|-21.6|55.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587749|NCT03349060|2919557|Superiority||Difference in Percentage|14.5||||0.4449|2-Sided|95.0|-21.6|50.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587750|NCT03349060|2919557|Superiority||Difference in Percentage|35.2||||0.0996|2-Sided|95.0|-2.0|72.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587751|NCT03349060|2919557|Superiority||Difference in Percentage|24.0||||0.2278|2-Sided|95.0|-9.9|58.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587752|NCT03349060|2919558|Superiority||Difference in Percentage|7.8||||0.5965|2-Sided|95.0|-20.4|36.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587998|NCT03346070|2919634|Superiority||Difference in percentage|-2.6|||||2-Sided|95.0|-18.0|13.1|||||Miettinen and Nurminen method||
1587999|NCT03346070|2919634|Superiority||Difference in percentage|5.1|||||2-Sided|95.0|-8.1|19.7|||||Miettinen and Nurminen method||
1587753|NCT03349060|2919558|Superiority||Difference in Percentage|-0.4||||0.976|2-Sided|95.0|-28.5|27.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587754|NCT03349060|2919558|Superiority||Difference in Percentage|37.3||||0.0123|2-Sided|95.0|12.1|62.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587755|NCT03349060|2919558|Superiority||Difference in Percentage|20.8||||0.1474|2-Sided|95.0|-4.5|46.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587756|NCT03349060|2919558|Superiority||Difference in Percentage|0.0||||1|2-Sided|95.0|-28.3|28.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587757|NCT03349060|2919558|Superiority||Difference in Percentage|-4.9||||0.746|2-Sided|95.0|-33.4|23.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587758|NCT03349060|2919558|Superiority||Difference in Percentage|27.9||||0.0561|2-Sided|95.0|0.8|55.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587759|NCT03349060|2919558|Superiority||Difference in Percentage|8.8||||0.5539|2-Sided|95.0|-19.6|37.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587760|NCT03349060|2919559|Superiority||Difference in LS mean|-1.0||||0.0085|2-Sided|95.0|-1.8|-0.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587761|NCT03349060|2919559|Superiority||Difference in LS mean|-0.5||||0.1675|2-Sided|95.0|-1.3|0.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587762|NCT03349060|2919559|Superiority||Difference in LS mean|-1.2||||0.0019|2-Sided|95.0|-2.0|-0.5|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587763|NCT03349060|2919559|Superiority||Difference in LS mean|-0.4||||0.2657|2-Sided|95.0|-1.2|0.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587764|NCT03349060|2919559|Superiority||Difference in LS mean|-1.2||||0.0012|2-Sided|95.0|-1.9|-0.5|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587765|NCT03349060|2919559|Superiority||Difference in LS mean|-0.5||||0.205|2-Sided|95.0|-1.2|0.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587766|NCT03349060|2919559|Superiority||Difference in LS mean|-0.7||||0.0422|2-Sided|95.0|-1.4|0.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587767|NCT03349060|2919559|Superiority||Difference in LS mean|-0.2||||0.6134|2-Sided|95.0|-0.9|0.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587768|NCT03349060|2919560|Superiority||Difference in LS mean|-1.6|||<|0.0001|2-Sided|95.0|-2.3|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587769|NCT03349060|2919560|Superiority||Difference in LS mean|-1.1|||<|0.0028|2-Sided|95.0|-1.9|-0.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587770|NCT03349060|2919560|Superiority||Difference in LS mean|-1.7|||<|0.0001|2-Sided|95.0|-2.4|-1.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587771|NCT03349060|2919560|Superiority||Difference in LS mean|-0.7|||<|0.0476|2-Sided|95.0|-1.5|0.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1588374|NCT03334396|2919967|Superiority||Odds Ratio (OR)|1.17||||0.874|2-Sided|95.0|0.17|7.77|||Regression, Logistic||||
1587772|NCT03349060|2919560|Superiority||Difference in LS mean|-1.8|||<|0.0001|2-Sided|95.0|-2.5|-1.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587773|NCT03349060|2919560|Superiority||Difference in LS mean|-1.3|||<|0.0005|2-Sided|95.0|-2.0|-0.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587774|NCT03349060|2919560|Superiority||Difference in LS mean|-1.1|||<|0.0018|2-Sided|95.0|-1.7|-0.4|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587775|NCT03349060|2919560|Superiority||Difference in LS mean|-0.5|||<|0.1718|2-Sided|95.0|-1.1|0.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587776|NCT03349060|2919561|Superiority||Difference in Percentage|30.6||||0.0296|2-Sided|95.0|2.8|58.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587777|NCT03349060|2919561|Superiority||Difference in Percentage|19.3||||0.1948|2-Sided|95.0|-9.8|48.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587778|NCT03349060|2919561|Superiority||Difference in Percentage|41.2||||0.0085|2-Sided|95.0|13.2|69.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587779|NCT03349060|2919561|Superiority||Difference in Percentage|31.0||||0.0583|2-Sided|95.0|2.0|59.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587780|NCT03349060|2919561|Superiority||Difference in Percentage|43.9||||0.003|2-Sided|95.0|16.2|71.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587781|NCT03349060|2919561|Superiority||Difference in Percentage|28.8||||0.0697|2-Sided|95.0|-0.8|58.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587782|NCT03349060|2919561|Superiority||Difference in Percentage|17.1||||0.2371|2-Sided|95.0|-9.0|43.3|||Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587783|NCT03349060|2919561|Superiority||Difference in Percentage|17.1||||0.2497|2-Sided|95.0|-9.1|43.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587784|NCT03349060|2919562|Superiority||Difference in Percentage|28.8||||0.0002|2-Sided|95.0|13.8|43.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587785|NCT03349060|2919562|Superiority||Difference in Percentage|23.5||||0.0035|2-Sided|95.0|8.2|38.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587786|NCT03349060|2919562|Superiority||Difference in Percentage|33.8|||<|0.0001|2-Sided|95.0|18.9|48.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587787|NCT03349060|2919562|Superiority||Difference in Percentage|16.5|||<|0.0421|2-Sided|95.0|0.6|32.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587788|NCT03349060|2919562|Superiority||Difference in Percentage|33.3|||<|0.0001|2-Sided|95.0|19.0|47.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587789|NCT03349060|2919562|Superiority||Difference in Percentage|20.4|||<|0.009|2-Sided|95.0|5.2|35.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1588000|NCT03346070|2919634|Superiority||Difference in percentage|-3.6|||||2-Sided|95.0|-19.6|12.2|||||Miettinen and Nurminen method||
1587790|NCT03349060|2919562|Superiority||Difference in Percentage|35.7|||<|0.0001|2-Sided|95.0|21.5|49.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587791|NCT03349060|2919562|Superiority||Difference in Percentage|31.6|||<|0.0001|2-Sided|95.0|17.2|46.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587792|NCT03349060|2919563|Superiority||Difference in Percentage|9.7||||0.2232|2-Sided|95.0|-6.1|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587793|NCT03349060|2919563|Superiority||Difference in Percentage|19.3||||0.0744|2-Sided|95.0|1.0|37.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587794|NCT03349060|2919563|Superiority||Difference in Percentage|5.8||||0.5777|2-Sided|95.0|-13.6|25.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587795|NCT03349060|2919563|Superiority||Difference in Percentage|5.8||||0.5707|2-Sided|95.0|-13.7|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587796|NCT03349060|2919563|Superiority||Difference in Percentage|9.7||||0.2232|2-Sided|95.0|-6.1|25.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587797|NCT03349060|2919563|Superiority||Difference in Percentage|13.3||||0.1452|2-Sided|95.0|-3.6|30.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587798|NCT03349060|2919563|Superiority||Difference in Percentage|0.0|||||2-Sided|95.0|-12.7|12.7||||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587799|NCT03349060|2919563|Superiority||Difference in Percentage|3.2||||0.4795|2-Sided|95.0|-10.3|16.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587800|NCT03349060|2919564|Superiority||Difference in Percentage|19.8||||0.0046|2-Sided|95.0|8.1|31.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587801|NCT03349060|2919564|Superiority||Difference in Percentage|8.1||||0.1837|2-Sided|95.0|-2.8|19.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587802|NCT03349060|2919564|Superiority||Difference in Percentage|26.5||||0.0002|2-Sided|95.0|15.3|37.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587803|NCT03349060|2919564|Superiority||Difference in Percentage|9.1||||0.1161|2-Sided|95.0|-0.9|19.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587804|NCT03349060|2919564|Superiority||Difference in Percentage|24.0||||0.0005|2-Sided|95.0|12.9|35.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587805|NCT03349060|2919564|Superiority||Difference in Percentage|6.8||||0.2091|2-Sided|95.0|-2.8|16.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587806|NCT03349060|2919564|Superiority||Difference in Percentage|20.1||||0.0008|2-Sided|95.0|11.0|29.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587807|NCT03349060|2919564|Superiority||Difference in Percentage|6.6||||0.1238|2-Sided|95.0|-0.7|13.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587808|NCT03349060|2919565|Superiority||Difference in LS mean|-3.6||||0.01|2-Sided|95.0|-6.2|-0.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587809|NCT03349060|2919565|Superiority||Difference in LS mean|-2.5||||0.0629|2-Sided|95.0|-5.2|0.1|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587810|NCT03349060|2919565|Superiority||Difference in LS mean|-4.4||||0.0048|2-Sided|95.0|-7.4|-1.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587811|NCT03349060|2919565|Superiority||Difference in LS mean|-2.1||||0.1706|2-Sided|95.0|-5.1|0.9|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587812|NCT03349060|2919565|Superiority||Difference in LS mean|-6.4|||<|0.0001|2-Sided|95.0|-8.8|-4.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587813|NCT03349060|2919565|Superiority||Difference in LS mean|-3.5|||<|0.0051|2-Sided|95.0|-5.9|-1.1|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587814|NCT03349060|2919565|Superiority||Difference in LS mean|-2.5|||<|0.028|2-Sided|95.0|-4.8|-0.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587815|NCT03349060|2919565|Superiority||Difference in LS mean|-1.3|||<|0.275|2-Sided|95.0|-3.5|1.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587816|NCT03349060|2919566|Superiority||Difference in LS mean|-4.9|||<|0.0001|2-Sided|95.0|-6.9|-2.9|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587817|NCT03349060|2919566|Superiority||Difference in LS mean|-2.8|||<|0.0072|2-Sided|95.0|-4.8|-0.8|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587818|NCT03349060|2919566|Superiority||Difference in LS mean|-5.3|||<|0.0001|2-Sided|95.0|-7.4|-3.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587819|NCT03349060|2919566|Superiority||Difference in LS mean|-2.8|||<|0.0075|2-Sided|95.0|-4.8|-0.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587820|NCT03349060|2919566|Superiority||Difference in LS mean|-6.1|||<|0.0001|2-Sided|95.0|-7.8|-4.5|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587821|NCT03349060|2919566|Superiority||Difference in LS mean|-3.3|||<|0.0001|2-Sided|95.0|-5.0|-1.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587822|NCT03349060|2919566|Superiority||Difference in LS mean|-5.5|||<|0.0001|2-Sided|95.0|-7.1|-3.9|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587823|NCT03349060|2919566|Superiority||Difference in LS mean|-3.8|||<|0.0001|2-Sided|95.0|-5.4|-2.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587824|NCT03349060|2919567|Superiority||Difference in Percentage|29.1|||<|0.0001|2-Sided|95.0|15.0|43.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587825|NCT03349060|2919567|Superiority||Difference in Percentage|20.1|||<|0.008|2-Sided|95.0|5.8|34.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587826|NCT03349060|2919567|Superiority||Difference in Percentage|23.7|||<|0.0011|2-Sided|95.0|9.8|37.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1588001|NCT03346070|2919634|Superiority||Difference in percentage|0.1|||||2-Sided|95.0|-12.7|13.1|||||Miettinen and Nurminen method||
1588002|NCT03346070|2919635|Superiority||Difference in percentage|-1.4||||0.299|2-Sided|95.0|-7.5|3.5|||Miettinen & Nurminen method||||
1587827|NCT03349060|2919567|Superiority||Difference in Percentage|15.7|||<|0.0363|2-Sided|95.0|1.4|30.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587828|NCT03349060|2919567|Superiority||Difference in Percentage|32.2|||<|0.0001|2-Sided|95.0|18.5|45.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587829|NCT03349060|2919567|Superiority||Difference in Percentage|17.1|||<|0.0217|2-Sided|95.0|2.8|31.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587830|NCT03349060|2919567|Superiority||Difference in Percentage|40.1|||<|0.0001|2-Sided|95.0|27.1|53.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587831|NCT03349060|2919567|Superiority||Difference in Percentage|22.3|||<|0.0028|2-Sided|95.0|8.7|35.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587832|NCT03349060|2919568|Superiority||Difference in LS mean|-21.9|||<|0.0001|2-Sided|95.0|-27.5|-16.3|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587833|NCT03349060|2919568|Superiority||Difference in LS mean|-13.3|||<|0.0001|2-Sided|95.0|-19.0|-7.7|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587834|NCT03349060|2919568|Superiority||Difference in LS mean|-22.0|||<|0.0001|2-Sided|95.0|-27.2|-16.7|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587835|NCT03349060|2919568|Superiority||Difference in LS mean|-14.3|||<|0.0001|2-Sided|95.0|-19.5|-9.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587836|NCT03349060|2919568|Superiority||Difference in LS mean|-22.1|||<|0.0001|2-Sided|95.0|-26.8|-17.3|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587837|NCT03349060|2919568|Superiority||Difference in LS mean|-12.6|||<|0.0001|2-Sided|95.0|-17.3|-7.8|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587838|NCT03349060|2919568|Superiority||Difference in LS mean|-18.9|||<|0.0001|2-Sided|95.0|-22.7|-15.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587839|NCT03349060|2919568|Superiority||Difference in LS mean|-10.9|||<|0.0001|2-Sided|95.0|-14.8|-7.0|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587840|NCT03349060|2919569|Superiority||Difference in LS mean|-2.1|||<|0.0001|2-Sided|95.0|-2.9|-1.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587841|NCT03349060|2919569|Superiority||Difference in LS mean|-1.3|||<|0.0005|2-Sided|95.0|-2.1|-0.6|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587842|NCT03349060|2919569|Superiority||Difference in LS mean|-2.5|||<|0.0001|2-Sided|95.0|-3.2|-1.8|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587843|NCT03349060|2919569|Superiority||Difference in LS mean|-1.5|||<|0.0001|2-Sided|95.0|-2.3|-0.8|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587844|NCT03349060|2919569|Superiority||Difference in LS mean|-2.7|||<|0.0001|2-Sided|95.0|-3.4|-2.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587845|NCT03349060|2919569|Superiority||Difference in LS mean|-1.6|||<|0.0001|2-Sided|95.0|-2.2|-0.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1588003|NCT03346070|2919635|Superiority||Difference in percentage|-2.7||||0.326|2-Sided|95.0|-13.8|7.3|||Miettinen & Nurminen method||||
1587846|NCT03349060|2919569|Superiority||Difference in LS mean|-2.3|||<|0.0001|2-Sided|95.0|-3.0|-1.7|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587847|NCT03349060|2919569|Superiority||Difference in LS mean|-1.3|||<|0.0001|2-Sided|95.0|-1.9|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587848|NCT03349060|2919570|Superiority||Difference in Percentage|26.4|||<|0.0001|2-Sided|95.0|17.6|35.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587849|NCT03349060|2919570|Superiority||Difference in Percentage|8.2|||<|0.0528|2-Sided|95.0|1.0|15.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587850|NCT03349060|2919570|Superiority||Difference in Percentage|22.2|||<|0.0001|2-Sided|95.0|14.2|30.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587851|NCT03349060|2919570|Superiority||Difference in Percentage|10.8|||<|0.0078|2-Sided|95.0|4.2|17.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587852|NCT03349060|2919570|Superiority||Difference in Percentage|15.3|||<|0.0019|2-Sided|95.0|7.3|23.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587853|NCT03349060|2919570|Superiority||Difference in Percentage|-0.2|||<|0.9402|2-Sided|95.0|-5.9|5.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587854|NCT03349060|2919570|Superiority||Difference in Percentage|6.0|||<|0.0292|2-Sided|95.0|0.7|11.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587855|NCT03349060|2919570|Superiority||Difference in Percentage|1.3|||<|0.3151|2-Sided|95.0|-2.9|5.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587856|NCT03349060|2919571|Superiority||Difference in Percentage|40.0|||<|0.0001|2-Sided|95.0|28.3|51.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587857|NCT03349060|2919571|Superiority||Difference in Percentage|19.6|||<|0.0026|2-Sided|95.0|8.1|31.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587858|NCT03349060|2919571|Superiority||Difference in Percentage|41.7|||<|0.0001|2-Sided|95.0|30.7|52.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587859|NCT03349060|2919571|Superiority||Difference in Percentage|23.5|||<|0.0003|2-Sided|95.0|12.6|34.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587860|NCT03349060|2919571|Superiority||Difference in Percentage|37.9|||<|0.0001|2-Sided|95.0|26.6|49.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587861|NCT03349060|2919571|Superiority||Difference in Percentage|21.2|||<|0.001|2-Sided|95.0|10.2|32.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587862|NCT03349060|2919571|Superiority||Difference in Percentage|30.0|||<|0.0001|2-Sided|95.0|21.0|39.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587863|NCT03349060|2919571|Superiority||Difference in Percentage|10.8|||<|0.0151|2-Sided|95.0|3.3|18.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587864|NCT03349060|2919572|Superiority||Difference in Percentage|33.3|||<|0.0001|2-Sided|95.0|24.0|42.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587865|NCT03349060|2919572|Superiority||Difference in Percentage|15.8|||<|0.0019|2-Sided|95.0|7.5|24.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587866|NCT03349060|2919572|Superiority||Difference in Percentage|26.6|||<|0.0001|2-Sided|95.0|17.1|36.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587867|NCT03349060|2919572|Superiority||Difference in Percentage|9.6|||<|0.0434|2-Sided|95.0|1.3|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587868|NCT03349060|2919572|Superiority||Difference in Percentage|23.6|||<|0.0001|2-Sided|95.0|15.1|32.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587869|NCT03349060|2919572|Superiority||Difference in Percentage|4.6|||<|0.2002|2-Sided|95.0|-2.1|11.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587870|NCT03349060|2919572|Superiority||Difference in Percentage|4.0|||<|0.1416|2-Sided|95.0|-1.3|9.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587871|NCT03349060|2919572|Superiority||Difference in Percentage|1.3|||<|0.521|2-Sided|95.0|-3.4|6.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587872|NCT03349060|2919573|Superiority||Difference in LS mean|-22.0|||<|0.0001|2-Sided|95.0|-27.6|-16.5|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587873|NCT03349060|2919573|Superiority||Difference in LS mean|-13.8|||<|0.0001|2-Sided|95.0|-19.3|-8.2|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587874|NCT03349060|2919573|Superiority||Difference in LS mean|-22.6|||<|0.0001|2-Sided|95.0|-28.0|-17.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587875|NCT03349060|2919573|Superiority||Difference in LS mean|-14.3|||<|0.0001|2-Sided|95.0|-19.7|-9.0|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587876|NCT03349060|2919573|Superiority||Difference in LS mean|-18.5|||<|0.0001|2-Sided|95.0|-23.4|-13.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587877|NCT03349060|2919573|Superiority||Difference in LS mean|-11.7|||<|0.0001|2-Sided|95.0|-16.6|-6.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587878|NCT03349060|2919573|Superiority||Difference in LS mean|-14.8|||<|0.0001|2-Sided|95.0|-19.0|-10.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587879|NCT03349060|2919573|Superiority||Difference in LS mean|-7.8|||<|0.0004|2-Sided|95.0|-12.1|-3.5|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587880|NCT03349060|2919574|Superiority||Difference in LS mean|-14.0|||<|0.0001|2-Sided|95.0|-17.3|-10.8|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587881|NCT03349060|2919574|Superiority||Difference in LS mean|-8.3|||<|0.0001|2-Sided|95.0|-11.6|-5.1|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587882|NCT03349060|2919574|Superiority||Difference in LS mean|-13.5|||<|0.0001|2-Sided|95.0|-16.5|-10.4|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587883|NCT03349060|2919574|Superiority||Difference in LS mean|-8.5|||<|0.0001|2-Sided|95.0|-11.6|-5.5|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587884|NCT03349060|2919574|Superiority||Difference in LS mean|-12.7|||<|0.0001|2-Sided|95.0|-15.6|-9.9|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587885|NCT03349060|2919574|Superiority||Difference in LS mean|-7.9|||<|0.0001|2-Sided|95.0|-10.7|-5.0|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587886|NCT03349060|2919574|Superiority||Difference in LS mean|-10.6|||<|0.0001|2-Sided|95.0|-13.0|-8.1|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587887|NCT03349060|2919574|Superiority||Difference in LS mean|-5.8|||<|0.0001|2-Sided|95.0|-8.2|-3.3|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587888|NCT03349060|2919575|Superiority||Difference in Percentage|13.1||||0.001|2-Sided|95.0|6.7|19.4|||Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587889|NCT03349060|2919575|Superiority||Difference in Percentage|6.4||||0.0255|2-Sided|95.0|1.2|11.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587890|NCT03349060|2919575|Superiority||Difference in Percentage|11.7||||0.0022|2-Sided|95.0|5.5|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587891|NCT03349060|2919575|Superiority||Difference in Percentage|4.6||||0.0604|2-Sided|95.0|-0.3|9.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587892|NCT03349060|2919575|Superiority||Difference in Percentage|6.5||||0.0234|2-Sided|95.0|1.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587893|NCT03349060|2919575|Superiority||Difference in Percentage|0.0|||||2-Sided|95.0|-3.9|3.9||||||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587894|NCT03349060|2919575|Superiority||Difference in Percentage|0.0|||||2-Sided|95.0|-3.8|3.8||||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587895|NCT03349060|2919575|Superiority||Difference in Percentage|0.0|||||2-Sided|95.0|-3.8|3.8||||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587896|NCT03349060|2919576|Superiority||Difference in Percentage|33.4|||<|0.0001|2-Sided|95.0|24.3|42.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587897|NCT03349060|2919576|Superiority||Difference in Percentage|13.3|||<|0.0066|2-Sided|95.0|5.4|21.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587898|NCT03349060|2919576|Superiority||Difference in Percentage|28.0|||<|0.0001|2-Sided|95.0|18.7|37.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587899|NCT03349060|2919576|Superiority||Difference in Percentage|9.0|||<|0.0423|2-Sided|95.0|1.3|16.8|||Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587900|NCT03349060|2919576|Superiority||Difference in Percentage|20.4|||<|0.0001|2-Sided|95.0|12.0|28.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587901|NCT03349060|2919576|Superiority||Difference in Percentage|3.9|||<|0.2576|2-Sided|95.0|-2.6|10.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1588004|NCT03346070|2919635|Superiority||Difference in percentage|0.3||||0.935|2-Sided|95.0|-11.1|11.9|||Miettinen & Nurminen method||||
1587902|NCT03349060|2919576|Superiority||Difference in Percentage|4.0|||<|0.1448|2-Sided|95.0|-1.2|9.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587903|NCT03349060|2919576|Superiority||Difference in Percentage|0.6|||<|0.7285|2-Sided|95.0|-3.9|5.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587904|NCT03349060|2919577|Superiority||Difference in Percentage|53.5|||<|0.0001|2-Sided|95.0|42.0|65.0||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587905|NCT03349060|2919577|Superiority||Difference in Percentage|35.3|||<|0.0001|2-Sided|95.0|23.3|47.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587906|NCT03349060|2919577|Superiority||Difference in Percentage|52.9|||<|0.0001|2-Sided|95.0|41.3|64.6|||Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587907|NCT03349060|2919577|Superiority||Difference in Percentage|34.1|||<|0.0001|2-Sided|95.0|21.9|46.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587908|NCT03349060|2919577|Superiority||Difference in Percentage|52.7|||<|0.0001|2-Sided|95.0|41.2|64.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587909|NCT03349060|2919577|Superiority||Difference in Percentage|33.5|||<|0.0001|2-Sided|95.0|21.6|45.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587910|NCT03349060|2919577|Superiority||Difference in Percentage|45.1|||<|0.0001|2-Sided|95.0|34.7|55.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587911|NCT03349060|2919577|Superiority||Difference in Percentage|24.0|||<|0.0001|2-Sided|95.0|13.9|34.1||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587912|NCT03349060|2919578|Superiority||Difference in Percentage|13.1||||0.001|2-Sided|95.0|6.7|19.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587913|NCT03349060|2919578|Superiority||Difference in Percentage|7.0||||0.019|2-Sided|95.0|1.7|12.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 12: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587914|NCT03349060|2919578|Superiority||Difference in Percentage|11.7||||0.0022|2-Sided|95.0|5.5|17.9||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587915|NCT03349060|2919578|Superiority||Difference in Percentage|4.6||||0.0592|2-Sided|95.0|-0.3|9.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587916|NCT03349060|2919578|Superiority||Difference in Percentage|6.5||||0.0234|2-Sided|95.0|1.3|11.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587917|NCT03349060|2919578|Superiority||Difference in Percentage|0.0|||||2-Sided|95.0|-3.9|3.9||||||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587918|NCT03349060|2919578|Superiority||Difference in Percentage|0.0|||||2-Sided|95.0|-3.8|3.8||||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587919|NCT03349060|2919578|Superiority||Difference in Percentage|0.0|||||2-Sided|95.0|-3.8|3.8||||||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1588005|NCT03346070|2919635|Superiority||Difference in percentage|-2.5||||0.335|2-Sided|95.0|-13.6|7.1|||Miettinen & Nurminen method||||
1588006|NCT03346070|2919635|Superiority||Difference in percentage|-2.6||||0.326|2-Sided|95.0|-13.7|7.0|||Miettinen & Nurminen method||||
1587920|NCT03349060|2919579|Superiority||Difference in Percentage|29.3|||<|0.0001|2-Sided|95.0|19.8|38.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587921|NCT03349060|2919579|Superiority||Difference in Percentage|13.8|||<|0.0071|2-Sided|95.0|5.2|22.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587922|NCT03349060|2919579|Superiority||Difference in Percentage|21.7|||<|0.0001|2-Sided|95.0|13.0|30.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587923|NCT03349060|2919579|Superiority||Difference in Percentage|5.2|||<|0.1888|2-Sided|95.0|-1.9|12.4||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587924|NCT03349060|2919579|Superiority||Difference in Percentage|9.8|||<|0.0045|2-Sided|95.0|4.0|15.7||P-value was adjusted by randomization strata (baseline disease severity and age category)|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587925|NCT03349060|2919579|Superiority||Difference in Percentage|3.9|||<|0.0802|2-Sided|95.0|-0.7|8.5||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587926|NCT03349060|2919580|Superiority||Difference in Percentage|44.6|||<|0.0001|2-Sided|95.0|33.6|55.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587927|NCT03349060|2919580|Superiority||Difference in Percentage|25.0|||<|0.0001|2-Sided|95.0|14.2|35.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 8: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587928|NCT03349060|2919580|Superiority||Difference in Percentage|33.0|||<|0.0001|2-Sided|95.0|21.7|44.2||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587929|NCT03349060|2919580|Superiority||Difference in Percentage|13.1|||<|0.0259|2-Sided|95.0|2.6|23.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 4: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587930|NCT03349060|2919580|Superiority||Difference in Percentage|20.3|||<|0.0001|2-Sided|95.0|12.0|28.6||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587931|NCT03349060|2919580|Superiority||Difference in Percentage|6.5|||<|0.0869|2-Sided|95.0|-0.3|13.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||Week 2: The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587932|NCT03349060|2919581|Superiority||||||<|0.0001||||||P-value was controlled by randomization strata.|Log Rank||||
1587933|NCT03349060|2919581|Superiority||||||<|0.0071||||||P-value was controlled by randomization strata.|Log Rank||||
1587934|NCT03349060|2919582|Superiority||Difference in LS mean|-2.3|||<|0.0001|2-Sided|95.0|-3.0|-1.6|||Mixed Models Analysis|||MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587935|NCT03349060|2919582|Superiority||Difference in LS mean|-1.3|||<|0.0002|2-Sided|95.0|-2.0|-0.6|||Mixed Models Analysis|||MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587936|NCT03349060|2919583|Superiority||Difference in LS mean|-2.1|||<|0.0001|2-Sided|95.0|-2.7|-1.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587937|NCT03349060|2919583|Superiority||Difference in LS mean|-1.1|||<|0.001|2-Sided|95.0|-1.7|-0.4|||Mixed Models Analysis|||Change at Week 12: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587938|NCT03349060|2919583|Superiority||Difference in LS mean|-1.9|||<|0.0001|2-Sided|95.0|-2.5|-1.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1588007|NCT03346070|2919635|Superiority||Difference in percentage|0.0|||>|0.999|2-Sided|95.0|-9.9|9.4|||Miettinen & Nurminen method||||
1588008|NCT03346070|2919635|Superiority||Difference in percentage|-2.7|||>|0.299|2-Sided|95.0|-13.9|6.7|||Miettinen & Nurminen method||||
1587939|NCT03349060|2919583|Superiority||Difference in LS mean|-0.9|||<|0.0035|2-Sided|95.0|-1.5|-0.3|||Mixed Models Analysis|||Change at Week 8: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587940|NCT03349060|2919583|Superiority||Difference in LS mean|-2.2|||<|0.0001|2-Sided|95.0|-2.8|-1.7|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587941|NCT03349060|2919583|Superiority||Difference in LS mean|-1.1|||<|0.0001|2-Sided|95.0|-1.6|-0.6|||Mixed Models Analysis|||Change at Week 4: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587942|NCT03349060|2919583|Superiority||Difference in LS mean|-1.6|||<|0.0001|2-Sided|95.0|-2.0|-1.2|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587943|NCT03349060|2919583|Superiority||Difference in least squares (LS) mean|-1.0|||<|0.0001|2-Sided|95.0|-1.4|-0.6|||Mixed Models Analysis|||Change at Week 2: MMRM contained fixed factors of treatment, week, treatment by week interaction, randomization strata (baseline disease severity and age category) and baseline value and used an unstructured covariance matrix.|
1587944|NCT03349060|2919584|Superiority||Difference in Percentage|47.8|||<|0.0001|2-Sided|95.0|34.6|61.1|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1587945|NCT03349060|2919584|Superiority||Difference in Percentage|28.7|||<|0.0001|2-Sided|95.0|15.3|42.1|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1587946|NCT03349060|2919584|Superiority||Difference in Percentage|41.8|||<|0.0001|2-Sided|95.0|26.2|57.4|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1587947|NCT03349060|2919584|Superiority||Difference in Percentage|12.5|||<|0.1138|2-Sided|95.0|-3.0|28.0|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1587948|NCT03349060|2919584|Superiority||Difference in Percentage|43.3|||<|0.0001|2-Sided|95.0|33.1|53.6|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1587949|NCT03349060|2919584|Superiority||Difference in Percentage|16.3|||<|0.0055|2-Sided|95.0|7.4|25.2|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1587950|NCT03349060|2919585|Superiority||Difference in Percentage|41.7|||<|0.0001|2-Sided|95.0|29.6|53.9|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1587951|NCT03349060|2919585|Superiority||Difference in Percentage|22.5|||<|0.0003|2-Sided|95.0|10.3|34.8|||Cochran-Mantel-Haenszel|||Week 12: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1587952|NCT03349060|2919585|Superiority||Difference in Percentage|45.3|||<|0.0001|2-Sided|95.0|32.7|57.8|||Cochran-Mantel-Haenszel|||Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1587953|NCT03349060|2919585|Superiority||Difference in Percentage|20.0|||<|0.0019|2-Sided|95.0|7.4|32.7|||Cochran-Mantel-Haenszel|||Week 8: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1587954|NCT03349060|2919585|Superiority||Difference in Percentage|41.1|||<|0.0001|2-Sided|95.0|27.8|54.4|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1587955|NCT03349060|2919585|Superiority||Difference in Percentage|15.0|||<|0.0251|2-Sided|95.0|1.9|28.0|||Cochran-Mantel-Haenszel|||Week 4: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1587956|NCT03349060|2919585|Superiority||Difference in Percentage|42.5|||<|0.0001|2-Sided|95.0|33.6|51.4|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the CMH risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1588009|NCT03346070|2919636|Superiority||Difference in percentage|6.6||||0.149|2-Sided|95.0|-2.6|16.8|||Miettinen & Nurminen method||||
1587957|NCT03349060|2919585|Superiority||Difference in Percentage|18.0|||<|0.0004|2-Sided|95.0|10.2|25.8|||Cochran-Mantel-Haenszel|||Week 2: Each complete imputed data set was analyzed using the Cochran-Mantel-Haenszel (CMH) risk difference method adjusting by randomization strata, separately for each week. Results from multiply imputed data sets were combined using Rubin's rules to obtain treatment difference, 95% CI and p-value.|
1587958|NCT03349060|2919586|Superiority||Difference in Percentage|51.0|||<|0.0001|2-Sided|95.0|40.5|61.5|||Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587959|NCT03349060|2919586|Superiority||Difference in Percentage|27.9|||<|0.0001|2-Sided|95.0|17.4|38.3||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587960|NCT03349060|2919587|Superiority||Difference in Percentage|36.0|||<|0.0001|2-Sided|95.0|26.2|45.7||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and CI for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587961|NCT03349060|2919587|Superiority||Difference in Percentage|15.8|||<|0.0037|2-Sided|95.0|6.8|24.8||P-value was adjusted by randomization strata (baseline disease severity and age category).|Cochran-Mantel-Haenszel|||The estimate and confidence interval (CI) for difference were calculated based on the weighted average of difference for each randomization stratum using the normal approximation of binomial proportions.|
1587962|NCT03346070|2919628|Superiority||Ratio of geometric means|0.66|||||2-Sided|95.0|0.57|0.77|||||Log transformation and t-distribution||
1587963|NCT03346070|2919628|Superiority||Ratio of geometric means|0.66|||||2-Sided|95.0|0.52|0.83|||||Log transformation and t-distribution||
1587964|NCT03346070|2919628|Superiority||Ratio of geometric means|0.19|||||2-Sided|95.0|0.14|0.27|||||Log transformation and t-distribution||
1587965|NCT03346070|2919628|Superiority||Ratio of geometric means|0.13|||||2-Sided|95.0|0.09|0.17|||||Log transformation and t-distribution||
1587966|NCT03346070|2919628|Superiority||Ratio of geometric means|0.66|||||2-Sided|95.0|0.54|0.81|||||Log transformation and t-distribution||
1587967|NCT03346070|2919629|Superiority||Ratio of geometric means|0.6|||||2-Sided|95.0|0.51|0.7|||||Log transformation and t-distribution||
1587968|NCT03346070|2919629|Superiority||Ratio of geometric means|0.56|||||2-Sided|95.0|0.44|0.72|||||Log transformation and t-distribution||
1587969|NCT03346070|2919629|Superiority||Ratio of geometric means|0.15|||||2-Sided|95.0|0.11|0.2|||||Log transformation and t-distribution||
1587970|NCT03346070|2919629|Superiority||Ratio of geometric means|0.09|||||2-Sided|95.0|0.07|0.13|||||Log transformation and t-distribution||
1587971|NCT03346070|2919629|Superiority||Ratio of geometric means|0.63|||||2-Sided|95.0|0.5|0.8|||||Log transformation and t-distribution||
1587972|NCT03346070|2919630|Superiority||Ratio of geometric means|0.59|||||2-Sided|95.0|0.48|0.72|||||Log transformation and t-distribution||
1587973|NCT03346070|2919630|Superiority||Ratio of geometric means|0.54|||||2-Sided|95.0|0.4|0.71|||||Log transformation and t-distribution||
1587974|NCT03346070|2919630|Superiority||Ratio of geometric means|0.14|||||2-Sided|95.0|0.1|0.19|||||Log transformation and t-distribution||
1587975|NCT03346070|2919630|Superiority||Ratio of geometric means|0.09|||||2-Sided|95.0|0.06|0.12|||||Log transformation and t-distribution||
1587976|NCT03346070|2919630|Superiority||Ratio of geometric means|0.64|||||2-Sided|95.0|0.48|0.86|||||Log transformation and t-distribution||
1587977|NCT03346070|2919631|Superiority||Difference in percentage|2.9|||||2-Sided|95.0|-4.8|11.0|||||Miettinen and Nurminen method||
1587978|NCT03346070|2919631|Superiority||Difference in percentage|2.8|||||2-Sided|95.0|-7.2|14.2|||||Miettinen and Nurminen method||
1587979|NCT03346070|2919631|Superiority||Difference in percentage|-78.7|||||2-Sided|95.0|-88.8|-61.1|||||Miettinen and Nurminen method||
1587980|NCT03346070|2919631|Superiority||Difference in percentage|-76.1|||||2-Sided|95.0|-87.2|-57.6|||||Miettinen and Nurminen method||
1587981|NCT03346070|2919631|Superiority||Difference in percentage|3.0|||||2-Sided|95.0|-10.8|16.9|||||Miettinen and Nurminen method||
1587982|NCT03346070|2919632|Superiority||Difference in percentage|0.2|||||2-Sided|95.0|-11.0|12.0|||||Miettinen and Nurminen method||
1587983|NCT03346070|2919632|Superiority||Difference in percentage|-0.2|||||2-Sided|95.0|-11.5|11.0|||||Miettinen and Nurminen method||
1587984|NCT03346070|2919632|Superiority||Difference in percentage|0.2|||||2-Sided|95.0|-11.2|11.7|||||Miettinen and Nurminen method||
1587985|NCT03346070|2919632|Superiority||Difference in percentage|-2.6|||||2-Sided|95.0|-13.7|7.0|||||Miettinen and Nurminen method||
1587986|NCT03346070|2919632|Superiority||Difference in percentage|-0.4|||||2-Sided|95.0|-12.3|10.8|||||Miettinen and Nurminen method||
1587987|NCT03346070|2919632|Superiority||Difference in percentage|-2.4|||||2-Sided|95.0|-13.4|7.3|||||Miettinen and Nurminen method||
1587988|NCT03346070|2919633|Superiority||Difference in percentage|-5.5|||||2-Sided|95.0|-13.9|1.2|||||Miettinen and Nurminen method||
1587989|NCT03346070|2919633|Superiority||Difference in percentage|0.5|||||2-Sided|95.0|-14.0|15.5|||||Miettinen and Nurminen method||
1587990|NCT03346070|2919633|Superiority||Difference in percentage|-2.9|||||2-Sided|95.0|-17.0|10.5|||||Miettinen and Nurminen method||
1587991|NCT03346070|2919633|Superiority||Difference in percentage|-8.0|||||2-Sided|95.0|-21.2|1.8|||||Miettinen and Nurminen method||
1587992|NCT03346070|2919633|Superiority||Difference in percentage|-5.3|||||2-Sided|95.0|-18.8|6.8|||||Miettinen and Nurminen method||
1587993|NCT03346070|2919633|Superiority||Difference in percentage|-8.5|||||2-Sided|95.0|-22.3|1.3|||||Miettinen and Nurminen method||
1587994|NCT03346070|2919633|Superiority||Difference in percentage|-2.6|||||2-Sided|95.0|-15.2|9.1|||||Miettinen and Nurminen method||
1587995|NCT03346070|2919634|Superiority||Difference in percentage|-1.8|||||2-Sided|95.0|-11.4|7.8|||||Miettinen and Nurminen method||
1587996|NCT03346070|2919634|Superiority||Difference in percentage|2.2|||||2-Sided|95.0|-12.5|17.0|||||Miettinen and Nurminen method||
1588010|NCT03346070|2919636|Superiority||Difference in percentage|-4.9||||0.339|2-Sided|95.0|-18.2|6.7|||Miettinen & Nurminen method||||
1588011|NCT03346070|2919636|Superiority||Difference in percentage|-1.2||||0.849|2-Sided|95.0|-16.2|12.4|||Miettinen & Nurminen method||||
1588012|NCT03346070|2919636|Superiority||Difference in percentage|5.0||||0.486|2-Sided|95.0|-9.9|19.7|||Miettinen & Nurminen method||||
1588013|NCT03346070|2919636|Superiority||Difference in percentage|2.4||||0.717|2-Sided|95.0|-12.0|16.4|||Miettinen & Nurminen method||||
1588014|NCT03346070|2919636|Superiority||Difference in percentage|11.1||||0.077|2-Sided|95.0|-1.7|26.3|||Miettinen & Nurminen method||||
1588015|NCT03346070|2919636|Superiority||Difference in percentage|2.2||||0.738|2-Sided|95.0|-12.3|17.4|||Miettinen & Nurminen method||||
1588016|NCT03346070|2919637|Superiority||Difference in percentage|1.3||||0.709|2-Sided|95.0|-6.8|9.6|||Miettinen & Nurminen method||||
1588017|NCT03346070|2919637|Superiority||Difference in percentage|2.9||||0.528|2-Sided|95.0|-8.4|15.9|||Miettinen & Nurminen method||||
1588018|NCT03346070|2919637|Superiority||Difference in percentage|-0.2||||0.95|2-Sided|95.0|-11.6|10.9|||Miettinen & Nurminen method||||
1588019|NCT03346070|2919637|Superiority||Difference in percentage|2.6||||0.571|2-Sided|95.0|-8.8|15.0|||Miettinen & Nurminen method||||
1588020|NCT03346070|2919637|Superiority||Difference in percentage|2.6||||0.567|2-Sided|95.0|-8.7|15.0|||Miettinen & Nurminen method||||
1588021|NCT03346070|2919637|Superiority||Difference in percentage|0.2||||0.969|2-Sided|95.0|-13.4|13.5|||Miettinen & Nurminen method||||
1588022|NCT03346070|2919637|Superiority||Difference in percentage|2.3||||0.602|2-Sided|95.0|-9.6|15.0|||Miettinen & Nurminen method||||
1588023|NCT03346070|2919638|Superiority||Hazard Ratio (HR)|2.13|||<|0.0001|2-Sided|95.0|1.5|3.01|||Log Rank||Cox regression model||
1588024|NCT03346070|2919638|Superiority||Hazard Ratio (HR)|2.38|||<|0.0005|2-Sided|95.0|1.44|3.93|||Log Rank||Cox regression model||
1588025|NCT03346070|2919638|Superiority||Hazard Ratio (HR)|61.4|||<|0.0001|2-Sided|95.0|14.13|266.77|||Log Rank||Cox regression model||
1588026|NCT03346070|2919638|Superiority||Hazard Ratio (HR)|25.9|||<|0.0001|2-Sided|95.0|9.72|69.03|||Log Rank||Cox regression model||
1588027|NCT03346070|2919638|Superiority||Hazard Ratio (HR)|1.92|||<|0.0075|2-Sided|95.0|1.18|3.1|||Log Rank||Cox regression model||
1588028|NCT03345407|2919657|Other||Posterior adjusted median difference|1.2|||||2-Sided|95.0|-1.7|4.0|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588029|NCT03345407|2919657|Other||Posterior adjusted median difference|-0.3|||||2-Sided|95.0|-4.5|3.8|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588030|NCT03345407|2919657|Other||Posterior adjusted median difference|-1.8|||||2-Sided|95.0|-5.7|2.3|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588031|NCT03345407|2919657|Other||Posterior adjusted median difference|-2.3|||||2-Sided|95.0|-6.1|1.8|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588032|NCT03345407|2919657|Other||Posterior adjusted median difference|-0.2|||||2-Sided|95.0|-4.1|3.6|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588033|NCT03345407|2919657|Other||Posterior adjusted median difference|2.4|||||2-Sided|95.0|-4.8|9.4|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588034|NCT03345407|2919657|Other||Posterior adjusted median difference|-0.4|||||2-Sided|95.0|-2.9|2.5|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588035|NCT03345407|2919657|Other||Posterior adjusted median difference|-0.8|||||2-Sided|95.0|-4.6|3.0|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588036|NCT03345407|2919657|Other||Posterior adjusted median difference|-3.3|||||2-Sided|95.0|-7.3|0.4|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588037|NCT03345407|2919657|Other||Posterior adjusted median difference|-2.7|||||2-Sided|95.0|-6.3|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588038|NCT03345407|2919657|Other||Posterior adjusted median difference|-1.2|||||2-Sided|95.0|-4.8|2.5|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588039|NCT03345407|2919657|Other||Posterior adjusted median difference|4.1|||||2-Sided|95.0|-2.5|11.0|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588040|NCT03345407|2919657|Other||Posterior adjusted median difference|-0.2|||||2-Sided|95.0|-2.7|2.3|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588041|NCT03345407|2919657|Other||Posterior adjusted median difference|-0.1|||||2-Sided|95.0|-4.0|3.5|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588042|NCT03345407|2919657|Other||Posterior adjusted median difference|-3.2|||||2-Sided|95.0|-6.7|0.4|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588043|NCT03345407|2919657|Other||Posterior adjusted median difference|-2.9|||||2-Sided|95.0|-6.2|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588044|NCT03345407|2919657|Other||Posterior adjusted median difference|-0.5|||||2-Sided|95.0|-4.0|3.1|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588045|NCT03345407|2919657|Other||Posterior adjusted median difference|2.0|||||2-Sided|95.0|-4.8|8.3|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588046|NCT03345407|2919658|Other||Posterior median odds ratio|1.03|||||2-Sided|95.0|0.71|1.43|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588047|NCT03345407|2919658|Other||Posterior median odds ratio|0.94|||||2-Sided|95.0|0.53|1.45|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588048|NCT03345407|2919658|Other||Posterior median odds ratio|1.35|||||2-Sided|95.0|0.75|2.14|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588049|NCT03345407|2919658|Other||Posterior median odds ratio|1.13|||||2-Sided|95.0|0.64|1.79|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588050|NCT03345407|2919658|Other||Posterior median odds ratio|1.27|||||2-Sided|95.0|0.72|2.01|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588051|NCT03345407|2919658|Other||Posterior median odds ratio|0.63|||||2-Sided|95.0|0.17|1.39|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588052|NCT03345407|2919658|Other||Posterior median odds ratio|1.1|||||2-Sided|95.0|0.75|1.5|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588053|NCT03345407|2919658|Other||Posterior median odds ratio|1.04|||||2-Sided|95.0|0.57|1.62|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588054|NCT03345407|2919658|Other||Posterior median odds ratio|1.47|||||2-Sided|95.0|0.83|2.27|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588055|NCT03345407|2919658|Other||Posterior median odds ratio|1.29|||||2-Sided|95.0|0.73|1.97|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588056|NCT03345407|2919658|Other||Posterior median odds ratio|1.27|||||2-Sided|95.0|0.74|1.98|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588057|NCT03345407|2919658|Other||Posterior median odds ratio|0.54|||||2-Sided|95.0|0.14|1.16|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588058|NCT03345407|2919658|Other||Posterior median odds ratio|0.95|||||2-Sided|95.0|0.6|1.4|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588059|NCT03345407|2919658|Other||Posterior median odds ratio|1.24|||||2-Sided|95.0|0.61|2.08|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588060|NCT03345407|2919658|Other||Posterior median odds ratio|1.78|||||2-Sided|95.0|0.95|2.91|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588061|NCT03345407|2919658|Other||Posterior median odds ratio|1.37|||||2-Sided|95.0|0.69|2.24|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588062|NCT03345407|2919658|Other||Posterior median odds ratio|0.87|||||2-Sided|95.0|0.42|1.47|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588063|NCT03345407|2919658|Other||Posterior median odds ratio|0.51|||||2-Sided|95.0|0.03|1.41|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588064|NCT03345407|2919659|Other||Posterior adjusted median difference|0.4|||||2-Sided|95.0|-0.8|1.7|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588065|NCT03345407|2919659|Other||Posterior adjusted median difference|0.8|||||2-Sided|95.0|-0.9|2.8|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588066|NCT03345407|2919659|Other||Posterior adjusted median difference|-0.1|||||2-Sided|95.0|-1.9|1.7|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588067|NCT03345407|2919659|Other||Posterior adjusted median difference|-0.5|||||2-Sided|95.0|-2.3|1.1|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 84 was performed and posterior adjsted median difference and 95% HPD CrI has been presented.||
1588068|NCT03345407|2919659|Other||Posterior adjusted median difference|1.1|||||2-Sided|95.0|-0.7|2.8|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588069|NCT03345407|2919659|Other||Posterior adjusted median difference|1.9|||||2-Sided|95.0|-1.4|5.1|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 84 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588070|NCT03345407|2919659|Other||Posterior adjusted median difference|-0.2|||||2-Sided|95.0|-1.4|1.0|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588151|NCT03343080|2919708|Superiority|||||||0.296|||||||t-test, 2 sided|||4 hours post-extubation|
1588071|NCT03345407|2919659|Other||Posterior adjusted median difference|0.4|||||2-Sided|95.0|-1.2|2.2|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588072|NCT03345407|2919659|Other||Posterior adjusted median difference|-0.5|||||2-Sided|95.0|-2.3|1.0|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588073|NCT03345407|2919659|Other||Posterior adjusted median difference|-0.3|||||2-Sided|95.0|-1.9|1.4|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588074|NCT03345407|2919659|Other||Posterior adjusted median difference|0.8|||||2-Sided|95.0|-0.9|2.4|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588075|NCT03345407|2919659|Other||Posterior adjusted median difference|2.3|||||2-Sided|95.0|-0.5|5.4|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 56 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588076|NCT03345407|2919659|Other||Posterior adjusted median difference|0.0|||||2-Sided|95.0|-1.1|1.1|||||Treatment comparison between placebo and Nemiralisib 750 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588077|NCT03345407|2919659|Other||Posterior adjacent median difference|1.6|||||2-Sided|95.0|0.0|3.3|||||Treatment comparison between placebo and Nemiralisib 500 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588078|NCT03345407|2919659|Other||Posterior adjusted median difference|-0.3|||||2-Sided|95.0|-2.0|1.2|||||Treatment comparison between placebo and Nemiralisib 250 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588079|NCT03345407|2919659|Other||Posterior adjusted median difference|0.8|||||2-Sided|95.0|-0.8|2.4|||||Treatment comparison between placebo and Nemiralisib 100 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588080|NCT03345407|2919659|Other||Posterior adjusted median difference|0.7|||||2-Sided|95.0|-0.8|2.3|||||Treatment comparison between placebo and Nemiralisib 50 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588081|NCT03345407|2919659|Other||Posterior adjusted median difference|2.4|||||2-Sided|95.0|-0.5|5.2|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg at Day 28 was performed and posterior adjusted median difference and 95% HPD CrI has been presented.||
1588082|NCT03345407|2919660|Other||Posterior median odds ratio|0.85|||||2-Sided|95.0|0.57|1.17|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588083|NCT03345407|2919660|Other||Posterior median odds ratio|0.65|||||2-Sided|95.0|0.36|1.02|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588084|NCT03345407|2919660|Other||Posterior median odds ratio|1.16|||||2-Sided|95.0|0.62|1.86|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588085|NCT03345407|2919660|Other||Posterior median odds ratio|0.83|||||2-Sided|95.0|0.46|1.3|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588086|NCT03345407|2919660|Other||Posterior median odds ratio|1.53|||||2-Sided|95.0|0.79|2.56|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588087|NCT03345407|2919660|Other||Posterior median odds ratio|0.54|||||2-Sided|95.0|0.16|1.2|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588088|NCT03345407|2919660|Other||Posterior median odds ratio|0.93|||||2-Sided|95.0|0.63|1.27|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588089|NCT03345407|2919660|Other||Posterior median odds ratio|0.76|||||2-Sided|95.0|0.43|1.17|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588090|NCT03345407|2919660|Other||Posterior median odds ratio|1.36|||||2-Sided|95.0|0.74|2.16|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588091|NCT03345407|2919660|Other||Posterior median odds ratio|0.95|||||2-Sided|95.0|0.53|1.48|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588092|NCT03345407|2919660|Other||Posterior median odds ratio|1.53|||||2-Sided|95.0|0.84|2.46|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588093|NCT03345407|2919660|Other||Posterior median odds ratio|0.64|||||2-Sided|95.0|0.2|1.41|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588094|NCT03345407|2919660|Other||Posterior median odds ratio|0.7|||||2-Sided|95.0|0.46|0.99|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588095|NCT03345407|2919660|Other||Posterior median odds ratio|1.11|||||2-Sided|95.0|0.61|1.75|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588096|NCT03345407|2919660|Other||Posterior median odds ratio|1.28|||||2-Sided|95.0|0.71|2.0|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588097|NCT03345407|2919660|Other||Posterior median odds ratio|1.41|||||2-Sided|95.0|0.77|2.17|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1599044|NCT02858401|2938154|Other|||||||1|||||||Fisher Exact||||
1588098|NCT03345407|2919660|Other||Posterior median odds ratio|1.11|||||2-Sided|95.0|0.63|1.77|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588099|NCT03345407|2919660|Other||Posterior median odds ratio|1.22|||||2-Sided|95.0|0.35|2.7|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588100|NCT03345407|2919662|Other||Posterior median hazard ratio|1.149|||||2-Sided|95.0|0.899|1.426|||||Treatment comparison between placebo and Nemiralisib 750 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.||
1588101|NCT03345407|2919662|Other||Posterior median hazard ratio|0.751|||||2-Sided|95.0|0.487|1.057|||||Treatment comparison between placebo and Nemiralisib 500 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.||
1588102|NCT03345407|2919662|Other||Posterior median hazard ratio|1.03|||||2-Sided|95.0|0.719|1.413|||||Treatment comparison between placebo and Nemiralisib 250 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.||
1588103|NCT03345407|2919662|Other||Posterior median hazard ratio|1.06|||||2-Sided|95.0|0.734|1.432|||||Treatment comparison between placebo and Nemiralisib 100 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.||
1588104|NCT03345407|2919662|Other||Posterior median hazard ratio|1.2|||||2-Sided|95.0|0.84|1.597|||||Treatment comparison between placebo and Nemiralisib 50 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.||
1588105|NCT03345407|2919662|Other||Posterior median hazard ratio|1.053|||||2-Sided|95.0|0.477|1.765|||||Treatment comparison between placebo and Nemiralisib 12.5 mcg was performed and posterior median hazard ratio and 95% HPD CrI has been presented.||
1588106|NCT03345407|2919663|Other||Posterior median odds ratio|1.08|||||2-Sided|95.0|0.73|1.47|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588107|NCT03345407|2919663|Other||Posterior median odds ratio|0.56|||||2-Sided|95.0|0.31|0.87|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588108|NCT03345407|2919663|Other||Posterior median odds ratio|0.95|||||2-Sided|95.0|0.55|1.48|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588109|NCT03345407|2919663|Other||Posterior median odds ratio|1.12|||||2-Sided|95.0|0.63|1.71|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588110|NCT03345407|2919663|Other||Posterior median odds ratio|1.29|||||2-Sided|95.0|0.7|2.0|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588111|NCT03345407|2919663|Other||Posterior median odds ratio|1.08|||||2-Sided|95.0|0.32|2.38|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 84 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588112|NCT03345407|2919663|Other||Posterior median odds ratio|1.04|||||2-Sided|95.0|0.71|1.42|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588113|NCT03345407|2919663|Other||Posterior median odds ratio|0.49|||||2-Sided|95.0|0.26|0.77|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588114|NCT03345407|2919663|Other||Posterior median odds ratio|1.09|||||2-Sided|95.0|0.62|1.67|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588115|NCT03345407|2919663|Other||Posterior median odds ratio|1.15|||||2-Sided|95.0|0.65|1.78|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588116|NCT03345407|2919663|Other||Posterior median odds ratio|1.46|||||2-Sided|95.0|0.84|2.27|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588117|NCT03345407|2919663|Other||Posterior median odds ratio|1.0|||||2-Sided|95.0|0.3|2.17|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 56 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588118|NCT03345407|2919663|Other||Posterior median odds ratio|1.08|||||2-Sided|95.0|0.72|1.49|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588119|NCT03345407|2919663|Other||Posterior median odds ratio|0.55|||||2-Sided|95.0|0.28|0.88|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588120|NCT03345407|2919663|Other||Posterior median odds ratio|1.12|||||2-Sided|95.0|0.63|1.74|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588121|NCT03345407|2919663|Other||Posterior median odds ratio|1.16|||||2-Sided|95.0|0.67|1.79|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588122|NCT03345407|2919663|Other||Posterior median odds ratio|1.53|||||2-Sided|95.0|0.82|2.33|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588123|NCT03345407|2919663|Other||Posterior median odds ratio|1.21|||||2-Sided|95.0|0.36|2.69|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 28 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588124|NCT03345407|2919663|Other||Posterior median odds ratio|1.16|||||2-Sided|95.0|0.77|1.63|||||Treatment comparison between placebo and nemiralisib 750 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588125|NCT03345407|2919663|Other||Posterior median odds ratio|0.75|||||2-Sided|95.0|0.38|1.25|||||Treatment comparison between placebo and nemiralisib 500 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588126|NCT03345407|2919663|Other||Posterior median odds ratio|0.94|||||2-Sided|95.0|0.5|1.49|||||Treatment comparison between placebo and nemiralisib 250 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588127|NCT03345407|2919663|Other||Posterior median odds ratio|0.99|||||2-Sided|95.0|0.54|1.61|||||Treatment comparison between placebo and nemiralisib 100 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588128|NCT03345407|2919663|Other||Posterior median odds ratio|1.37|||||2-Sided|95.0|0.76|2.17|||||Treatment comparison between placebo and nemiralisib 50 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588129|NCT03345407|2919663|Other||Posterior median odds ratio|1.01|||||2-Sided|95.0|0.21|2.3|||||Treatment comparison between placebo and nemiralisib 12.5 mcg at Day 14 was performed and posterior median odds ratio and 95% HPD CrI has been presented.||
1588130|NCT03345407|2919666|Other||Posterior median hazard ratio|1.149|||||2-Sided|95.0|0.8|1.539|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for time to next moderate/severe exacerbations has been presented.||
1588131|NCT03345407|2919666|Other||Posterior median hazard ratio|0.556|||||2-Sided|95.0|0.268|0.902|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for time to next moderate/severe exacerbations has been presented.||
1588132|NCT03345407|2919666|Other||Posterior median hazard ratio|1.132|||||2-Sided|95.0|0.682|1.709|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for time to next moderate/severe exacerbations has been presented.||
1588133|NCT03345407|2919666|Other||Posterior median hazard ratio|0.975|||||2-Sided|95.0|0.581|1.467|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for time to next moderate/severe exacerbations has been presented.||
1588134|NCT03345407|2919666|Other||Posterior median hazard ratio|0.991|||||2-Sided|95.0|0.58|1.5|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for time to next moderate/severe exacerbations has been presented.||
1588135|NCT03345407|2919666|Other||Posterior median hazard ratio|0.455|||||2-Sided|95.0|0.054|1.103|||||Treatment comparison (Hazard Ratio and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for time to next moderate/severe exacerbations has been presented.||
1588136|NCT03345407|2919667|Other||Posterior median exacerbation rate ratio|1.13|||||2-Sided|95.0|0.85|1.52|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for moderate/severe exacerbations has been presented.||
1588137|NCT03345407|2919667|Other||Posterior median exacerbation rate ratio|0.63|||||2-Sided|95.0|0.37|1.02|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for moderate/severe exacerbations has been presented.||
1588138|NCT03345407|2919667|Other||Posterior median exacerbation rate ratio|1.01|||||2-Sided|95.0|0.65|1.5|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for moderate/severe exacerbations has been presented.||
1588139|NCT03345407|2919667|Other||Posterior median exacerbation rate ratio|0.89|||||2-Sided|95.0|0.57|1.35|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for moderate/severe exacerbations has been presented.||
1588140|NCT03345407|2919667|Other||Posterior median exacerbation rate ratio|0.92|||||2-Sided|95.0|0.6|1.4|||||Treatment comparison (posterior median exacerbation rate ratio and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for moderate/severe exacerbations has been presented.||
1588141|NCT03345407|2919668|Other||Posterior adjusted median difference|-0.004|||||2-Sided|95.0|-0.051|0.042|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 750 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.||
1588142|NCT03345407|2919668|Other||Posterior adjusted median difference|-0.003|||||2-Sided|95.0|-0.075|0.061|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 500 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.||
1588143|NCT03345407|2919668|Other||Posterior adjusted median difference|0.005|||||2-Sided|95.0|-0.064|0.071|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 250 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.||
1588144|NCT03345407|2919668|Other||Posterior adjusted median difference|-0.038|||||2-Sided|95.0|-0.102|0.028|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 100 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.||
1588145|NCT03345407|2919668|Other||Posterior adjusted median difference|-0.027|||||2-Sided|95.0|-0.098|0.036|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 50 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.||
1588146|NCT03345407|2919668|Other||Posterior adjusted median difference|-0.022|||||2-Sided|95.0|-0.143|0.103|||||Treatment comparison (posterior adjusted median difference and 95% HPD CrI) of Nemiralisib 12.5 mcg and placebo for Day 84 change from Baseline FEV1 measured post-bronchodilator has been presented.||
1588147|NCT03344861|2919670|Other||||||<|0.05|||||||exact Clopper-Pearson binomial method|One-sided 95% upper confidence limit for the event percentage, calculated using exact (Clopper-Pearson) method for binomial proportion.||"All adverse event terms are coded using MedDRA Dictionary version 21.1. NCS (Non-Clinical Significant) events were not included in the summary because their CTCAE grade and relationship were not collected. Subjects are counted once within each system organ class and each preferred term. An AE is defined as treatment related if its relationship to the study drug is recorded as reasonable possibility on the CRF (Case Report Form)."|
1588148|NCT03344861|2919695|Other|No comparator arm.|Clopper-Pearson (binomial proportion)|0.05|||<|0.05|2-Sided||||||exact Clopper-Pearson binomial method|One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion.|One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion|Adverse events will be listed, coded by MedDRA, by system organ class and preferred term.|
1588149|NCT03344172|2919702|Superiority||Mean Difference (Final Values)|-0.63|Standard Deviation|0.52||0.13|2-Sided|95.0|-1.0|-0.25|||t-test, 2 sided||||
1588150|NCT03344172|2919703|Superiority||Odds Ratio (OR)|0.52||||0.63|2-Sided|95.0|0.3|6.71|||Fisher Exact||||
1588153|NCT03341923|2919753|Superiority|After demonstrating noninferiority, if lower limit of CI was above 0% as superiority criteria, superiority was to be demonstrated.|Difference in proportion|6.1||||0.0455|2-Sided|95.0|0.2|11.9|||McNemar||||
1588154|NCT03341923|2919753|Non-Inferiority|Difference (DT1MF-AMMF) of percentage of subjects rated as “Optimal” was provided with two-sided 95% confidence interval (CI). If lower limit of CI was above -10% as non-inferiority criteria, non-inferiority was to be demonstrated.|Difference in proportion|6.1||||0.0455|2-Sided|95.0|0.2|11.9|||McNemar||||
1588155|NCT03341533|2919770|Equivalence|The null hypothesis is that the postoperative BPI pain severity score will be the same between groups|difference in medians|-0.3||||0.8|2-Sided||||||Kruskal-Wallis||Ice Packs - Usual Care||
1588156|NCT03341533|2919771|Equivalence|The null hypothesis is that the outpatient MME consumption will be the same across the two groups.|difference in medians|-7.5||||0.75|2-Sided||||||Kruskal-Wallis||Ice packs - Usual Care||
1588157|NCT03341533|2919772|Equivalence|The null hypothesis is that there is no difference in MME use on the hospital floor between groups.|Difference of medians|-4.5||||0.88|2-Sided||||||Kruskal-Wallis||Ice packs - Usual care||
1588158|NCT03341533|2919773|Equivalence|The null hypothesis is that there is no difference in NPIS between the two groups.|difference in medians|0.0||||0.39|2-Sided||||||Kruskal-Wallis||||
1588159|NCT03341299|2919774|Superiority||difference in LS means|-14.5||||0.719|2-Sided|95.0|-94.38|65.38|||Mixed Models Analysis||||
1588160|NCT03341299|2919775|Superiority||Ratio of geometric least square means|0.991||||0.7734|2-Sided|95.0|0.932|1.05|||Mixed Models Analysis||||
1588161|NCT03339726|2919789|Superiority||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.309||0.604|2-Sided|95.0|-0.77|0.45||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588162|NCT03339726|2919789|Superiority||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.312||0.218|2-Sided|95.0|-1.0|0.23||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588163|NCT03339726|2919789|Superiority||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.309||0.468|2-Sided|95.0|-0.83|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588164|NCT03339726|2919790|Superiority||Mean Difference (Final Values)|-0.18|Standard Error of the Mean|0.285||0.532|2-Sided|95.0|-0.74|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588165|NCT03339726|2919790|Superiority||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.287||0.997|2-Sided|95.0|-0.56|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588166|NCT03339726|2919790|Superiority||Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.284||0.529|2-Sided|95.0|-0.38|0.74||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588167|NCT03339726|2919791|Superiority||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.275||0.316|2-Sided|95.0|-0.82|0.27||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588168|NCT03339726|2919791|Superiority||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.278||0.865|2-Sided|95.0|-0.5|0.6||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588169|NCT03339726|2919791|Superiority||Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.275||0.24|2-Sided|95.0|-0.22|0.87||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588170|NCT03339726|2919792|Superiority||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.266||0.625|2-Sided|95.0|-0.66|0.4||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588171|NCT03339726|2919792|Superiority||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.269||0.631|2-Sided|95.0|-0.4|0.66||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588172|NCT03339726|2919792|Superiority||Mean Difference (Final Values)|0.26|Standard Error of the Mean|0.266||0.33|2-Sided|95.0|-0.27|0.79||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588173|NCT03339726|2919793|Superiority||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.255||0.82|2-Sided|95.0|-0.45|0.56||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588174|NCT03339726|2919793|Superiority||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.257||0.628|2-Sided|95.0|-0.38|0.63||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588291|NCT03334422|2919944|Superiority||LSMean Difference|-14.15|Standard Error of the Mean|3.32|<|0.001|2-Sided|95.0|-20.69|-7.61|||Mixed Models Analysis||||
1588175|NCT03339726|2919793|Superiority||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.255||0.794|2-Sided|95.0|-0.44|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588176|NCT03339726|2919794|Superiority||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.267||0.864|2-Sided|95.0|-0.48|0.57||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588177|NCT03339726|2919794|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.269||0.839|2-Sided|95.0|-0.59|0.48||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588178|NCT03339726|2919794|Superiority||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.267||0.707|2-Sided|95.0|-0.63|0.43||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588179|NCT03339726|2919795|Superiority||Mean Difference (Final Values)|0.27|Standard Error of the Mean|0.23||0.236|2-Sided|95.0|-0.18|0.73||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588180|NCT03339726|2919795|Superiority||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.232||0.39|2-Sided|95.0|-0.26|0.66||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588181|NCT03339726|2919795|Superiority||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.23||0.75|2-Sided|95.0|-0.53|0.38||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588182|NCT03339726|2919796|Superiority||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.218||0.874|2-Sided|95.0|-0.465|0.395||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588183|NCT03339726|2919796|Superiority||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.22||0.734|2-Sided|95.0|-0.359|0.508||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588184|NCT03339726|2919796|Superiority||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.218||0.616|2-Sided|95.0|-0.32|0.539||The significance threshold level was 0.05 (two sided).|ANCOVA|Treatment and baseline sinus pressure/tenderness score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588185|NCT03339726|2919797|Superiority||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.31||0.76|2-Sided|95.0|-0.71|0.52||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588186|NCT03339726|2919797|Superiority||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.312||0.394|2-Sided|95.0|-0.88|0.35||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588187|NCT03339726|2919797|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.309||0.579|2-Sided|95.0|-0.78|0.44||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588188|NCT03339726|2919798|Superiority||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.299||0.532|2-Sided|95.0|-0.78|0.4||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588189|NCT03339726|2919798|Superiority||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.301||0.924|2-Sided|95.0|-0.57|0.62||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588190|NCT03339726|2919798|Superiority||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.298||0.469|2-Sided|95.0|-0.37|0.8||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588191|NCT03339726|2919799|Superiority||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.273||0.329|2-Sided|95.0|-0.8|0.27||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588192|NCT03339726|2919799|Superiority||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.275||0.877|2-Sided|95.0|-0.5|0.58||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588193|NCT03339726|2919799|Superiority||Mean Difference (Final Values)|0.31|Standard Error of the Mean|0.272||0.257|2-Sided|95.0|-0.23|0.85||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588214|NCT03337308|2919862|Superiority||Difference of LS means|-9.3|Standard Error of the Mean|3.09||0.003|2-Sided|98.0|-16.5|-2.1||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means||
1588194|NCT03339726|2919800|Superiority||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.265||0.401|2-Sided|95.0|-0.74|0.3||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588195|NCT03339726|2919800|Superiority||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.266||0.97|2-Sided|95.0|-0.54|0.52||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588196|NCT03339726|2919800|Superiority||Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.264||0.421|2-Sided|95.0|-0.31|0.73||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588197|NCT03339726|2919801|Superiority||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.251||0.676|2-Sided|95.0|-0.6|0.39||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588198|NCT03339726|2919801|Superiority||Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.253||0.27|2-Sided|95.0|-0.22|0.78||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588199|NCT03339726|2919801|Superiority||Mean Difference (Final Values)|0.38|Standard Error of the Mean|0.25||0.126|2-Sided|95.0|-0.11|0.88||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588200|NCT03339726|2919802|Superiority||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.272||0.678|2-Sided|95.0|-0.65|0.42||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588201|NCT03339726|2919802|Superiority||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.273||0.952|2-Sided|95.0|-0.52|0.56||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588202|NCT03339726|2919802|Superiority||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.271||0.633|2-Sided|95.0|-0.4|0.66||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588203|NCT03339726|2919803|Superiority||Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.23||0.22|2-Sided|95.0|-0.17|0.74||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588204|NCT03339726|2919803|Superiority||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.232||0.085|2-Sided|95.0|-0.06|0.86||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588205|NCT03339726|2919803|Superiority||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.23||0.607|2-Sided|95.0|-0.33|0.57|||ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588206|NCT03339726|2919804|Superiority||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.261||0.389|2-Sided|95.0|-0.741|0.289||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588207|NCT03339726|2919804|Superiority||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.263||0.938|2-Sided|95.0|-0.498|0.539||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588208|NCT03339726|2919804|Superiority||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.26||0.346|2-Sided|95.0|-0.267|0.759||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588209|NCT03339726|2919805|Superiority||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.22||0.645|2-Sided|95.0|-0.537|0.333||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588210|NCT03339726|2919805|Superiority||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.222||0.569|2-Sided|95.0|-0.311|0.564||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588211|NCT03339726|2919805|Superiority||Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.22||0.3|2-Sided|95.0|-0.205|0.662||The significance threshold level was 0.05 (two sided).|ANOVA|Treatment and baseline nasal congestion score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1588212|NCT03339453|2919828|Non-Inferiority|95% Confidence Interval of the treatment differences in treatment success rate.|Risk Difference (RD)|0.0|||||2-Sided|95.0|-1.52|1.52|||||||
1588213|NCT03338816|2919840|Superiority||Rate ratio|0.26|||<|0.0001|2-Sided|95.0|0.16|0.41||P=6.040E-09|Negative binomial regression model|||Negative binomial regression model with treatment group and stratification factors (prior hemin prophylaxis status and historical attack rates) as fixed effects and the logarithm of the follow-up time as an offset variable.|
1588372|NCT03334396|2919967|Superiority||Odds Ratio (OR)|2.72||||0.201|2-Sided|95.0|0.59|12.65|||Regression, Logistic||||
1588215|NCT03337308|2919862|Superiority||Difference of LS means|-12.8|Standard Error of the Mean|3.23|<|0.001|2-Sided|98.0|-20.3|-5.3||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means||
1588216|NCT03337308|2919862|Superiority||Difference of LS means|-30.1|Standard Error of the Mean|3.81|<|0.001|2-Sided|99.0|-39.9|-20.3||using alpha = 0.01|ANCOVA||Standard Error of the Difference of LS Means||
1588217|NCT03337308|2919863|Superiority||Difference of LS means|-10.4|Standard Error of the Mean|2.48|<|0.001|2-Sided|98.0|-16.1|-4.6||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means||
1588218|NCT03337308|2919863|Superiority||Difference of LS means|-14.2|Standard Error of the Mean|2.64|<|0.001|2-Sided|98.0|-20.4|-8.1||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means||
1588219|NCT03337308|2919863|Superiority||Difference of LS means|-27.1|Standard Error of the Mean|3.11|<|0.001|2-Sided|99.0|-35.1|-19.1||using alpha = 0.01|ANCOVA||Standard Error of the Difference of LS Means||
1588220|NCT03337308|2919864|Superiority||Difference in LS means|-12.1|Standard Error of the Mean|3.03|<|0.001|2-Sided|98.0|-19.1|-5.0||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means||
1588221|NCT03337308|2919864|Superiority||Difference in LS means|-17.8|Standard Error of the Mean|3.12|<|0.001|2-Sided|98.0|-25.1|-10.5||using alpha = 0.02|ANCOVA||Standard Error of the Difference of LS Means||
1588222|NCT03337308|2919864|Superiority|using alpha = 0.01|Difference in LS mean|-33.7|Standard Error of the Mean|3.97|<|0.001|2-Sided|99.0|-43.9|-23.4|||ANCOVA||Standard Error of the Difference of LS Means||
1588223|NCT03337308|2919865|Superiority||Median Difference (Final Values)|-2.6|Standard Error of the Mean|8.08||0.734|2-Sided|98.0|-21.35|16.25||using alpha = 0.02|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference||
1588224|NCT03337308|2919865|Superiority||Median Difference (Final Values)|-25.6|Standard Error of the Mean|8.14||0.002|2-Sided|98.0|-45.0|-7.15||using alpha = 0.02|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference||
1588225|NCT03337308|2919865|Superiority||Location shift|-46.1|Standard Error of the Mean|12.22|<|0.001|2-Sided|99.0|-78.75|-15.78||using alpha = 0.01|Wilcoxon rank sum test||Standard Error of the Hodges-Lehmann Median Difference||
1588226|NCT03337308|2919866|Superiority||Difference of LS means|-13.1|Standard Error of the Mean|3.37|<|0.001|2-Sided|95.0|-19.7|-6.5|||ANCOVA||Standard Error of the Difference of LS Means||
1588227|NCT03337308|2919866|Superiority||Difference of LS means|-19.0|Standard Error of the Mean|3.6|<|0.001|2-Sided|95.0|-26.1|-11.9|||ANCOVA||Standard Error of the Difference of LS Means||
1588228|NCT03337308|2919866|Superiority||Difference of Least Squares (LS) means|-38.0|Standard Error of the Mean|4.32|<|0.001|2-Sided|95.0|-46.5|-29.6|||ANCOVA||Standard Error of the Difference of Least Squares (LS) Means||
1588229|NCT03336853|2919867|Superiority||Mean Difference (Final Values)|0.74|||<|0.0001|2-Sided|95.0|0.66|0.82|||t-test, 2 sided||||
1588230|NCT03334812|2919898|Superiority||Mean Difference (Net)|0.19||||0.1476|2-Sided|95.0|-0.22|0.6|||Mixed Effect Model Repeat Measurement|||SCD/HNWB - Week 28|
1588231|NCT03334812|2919898|Superiority||Mean Difference (Net)|-0.01||||0.5175|2-Sided|95.0|-0.26|0.25|||Mixed Effect Model Repeat Measurement|||SCD/HNWB - Week 12|
1588232|NCT03334812|2919899|Superiority||Mean Difference (Net)|23.8||||0.1168|2-Sided|96.0|-19.3|66.89|||Mixed Models Analysis|||Week 28 (EOS)|
1588233|NCT03334812|2919899|Superiority||Mean Difference (Net)|27.82||||0.1381|2-Sided|95.0|-26.5|82.1|||Mixed Effect Model Repeat Measurement|||Week 12|
1588234|NCT03334812|2919899|Superiority||Mean Difference (Net)|26.23||||0.0404|2-Sided|95.0|-3.86|56.32|||Mixed Effect Model Repeat Measurement|||Week 4|
1588235|NCT03334812|2919901|Superiority||Mean Difference (Final Values)|0.06||||0.3067|2-Sided|95.0|-0.19|0.31|||Mixed Effect Model Repeat Measurement||||
1588236|NCT03334812|2919902|Superiority||Mean Difference (Net)|-0.01||||0.5438|2-Sided|95.0|-0.28|0.25|||Mixed Effect Model Repeat Measurement|||DTBT/HWB|
1588237|NCT03334812|2919902|Superiority||Mean Difference (Net)|0.18||||0.1219|2-Sided|95.0|-0.15|0.51|||Mixed Effect Model Repeat Measurement|||SCD/HNWB|
1588238|NCT03334448|2919930|Superiority||Ration of Lease Square Means|0.97|||||2-Sided|90.0|0.83|1.09|||||||
1588239|NCT03334448|2919931|Superiority||Ratio of Geometric Least Square Means|0.83|||||2-Sided|90.0|0.818|0.957|||||||
1588240|NCT03334422|2919932|Superiority||Odds Ratio (OR)|5.14|||<|0.001|2-Sided|95.0|2.25|11.74|||Regression, Logistic||||
1588241|NCT03334422|2919932|Superiority||Odds Ratio (OR)|2.37|||<|0.064|2-Sided|95.0|0.95|5.92|||Regression, Logistic||||
1588242|NCT03334422|2919932|Superiority||Odds Ratio (OR)|0.93|||<|0.905|2-Sided|95.0|0.3|2.93|||Regression, Logistic||||
1588243|NCT03334422|2919933|Superiority||LSMean Difference|8.82|Standard Error of the Mean|3.14||0.006|2-Sided|95.0|2.62|15.01|||Mixed Models Analysis|||EQ-5D-5L VAS Score|
1588244|NCT03334422|2919933|Superiority||LSMean Difference|8.19|Standard Error of the Mean|3.33||0.015|2-Sided|95.0|1.63|14.76|||Mixed Models Analysis|||EQ-5D-5L VAS Score|
1588245|NCT03334422|2919933|Superiority||LSMean Difference|0.4|Standard Error of the Mean|3.47||0.907|2-Sided|95.0|-6.44|7.25|||Mixed Models Analysis|||EQ-5D-5L VAS Score|
1588246|NCT03334422|2919934|Superiority||LSMean Difference|0.11|Standard Error of the Mean|0.03|<|0.001|2-Sided|95.0|0.05|0.17|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)|
1588247|NCT03334422|2919934|Superiority||LSMean Difference|0.11|Standard Error of the Mean|0.03|<|0.001|2-Sided|95.0|0.04|0.17|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)|
1588248|NCT03334422|2919934|Superiority||LSMean Difference|0.03|Standard Error of the Mean|0.03|<|0.334|2-Sided|95.0|-0.03|0.1|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)|
1588249|NCT03334422|2919934|Superiority||LSMean Difference|0.08|Standard Error of the Mean|0.02|<|0.001|2-Sided|95.0|0.03|0.12|||Mixed Models Analysis|||Health State Index Score (US Algorithm)|
1588250|NCT03334422|2919934|Superiority||LSMean Difference|0.08|Standard Error of the Mean|0.02|<|0.001|2-Sided|95.0|0.03|0.12|||Mixed Models Analysis|||Health State Index Score (US Algorithm)|
1588251|NCT03334422|2919934|Superiority||LSMean Difference|0.02|Standard Error of the Mean|0.02|<|0.295|2-Sided|95.0|-0.02|0.07|||Mixed Models Analysis|||Health State Index Score (US Algorithm)|
1588373|NCT03334396|2919967|Superiority||Odds Ratio (OR)|2.88||||0.176|2-Sided|95.0|0.62|13.36|||Regression, Logistic||||
1588252|NCT03334422|2919935|Superiority||LSMean Difference|-14.47|Standard Error of the Mean|3.88|<|0.001|2-Sided|95.0|-22.11|-6.83|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline|
1588253|NCT03334422|2919935|Superiority||LSMean Difference|-14.3|Standard Error of the Mean|4.12|<|0.001|2-Sided|95.0|-22.43|-6.17|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline|
1588254|NCT03334422|2919935|Superiority||LSMean Difference|-2.26|Standard Error of the Mean|4.25|<|0.595|2-Sided|95.0|-10.65|6.12|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline|
1588255|NCT03334422|2919935|Superiority|Overall Work Impairment|LSMean Difference|-9.13|Standard Error of the Mean|6.07|<|0.135|2-Sided|95.0|-21.17|2.9|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline|
1588256|NCT03334422|2919935|Superiority||LSMean Difference|-9.48|Standard Error of the Mean|6.57|<|0.152|2-Sided|95.0|-22.51|3.55|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline|
1588257|NCT03334422|2919935|Superiority||LSMean Difference|-1.81|Standard Error of the Mean|6.71|<|0.788|2-Sided|95.0|-15.12|11.49|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline|
1588258|NCT03334422|2919935|Superiority||LSMean Difference|-13.13|Standard Error of the Mean|5.08|<|0.011|2-Sided|95.0|-23.2|-3.06|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline|
1588259|NCT03334422|2919935|Superiority||LSMean Difference|-13.56|Standard Error of the Mean|5.5|<|0.015|2-Sided|95.0|-24.45|-2.86|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline|
1588260|NCT03334422|2919935|Superiority||LSMean Difference|-3.12|Standard Error of the Mean|5.63|<|0.58|2-Sided|95.0|-14.26|8.02|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline|
1588261|NCT03334422|2919935|Superiority||LSMean Difference|5.16|Standard Error of the Mean|4.6|<|0.264|2-Sided|95.0|-3.95|14.26|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline|
1588262|NCT03334422|2919935|Superiority||LSMean Difference|1.01|Standard Error of the Mean|5.03|<|0.841|2-Sided|95.0|-8.94|10.97||Absenteeism|Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline|
1588263|NCT03334422|2919935|Superiority||LSMean Difference|-0.91|Standard Error of the Mean|5.17|<|0.861|2-Sided|95.0|-11.16|9.34|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline|
1588264|NCT03334422|2919936|Superiority||LSMean Difference|-4.22|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-5.98|-2.45|||Mixed Models Analysis||||
1588265|NCT03334422|2919936|Superiority||LSMean Difference|-4.09|Standard Error of the Mean|0.93|<|0.001|2-Sided|95.0|-5.92|-2.26|||Mixed Models Analysis||||
1588266|NCT03334422|2919936|Superiority||LSMean Difference|-1.76|Standard Error of the Mean|0.97|<|0.071|2-Sided|95.0|-3.67|0.15|||Mixed Models Analysis||||
1588267|NCT03334422|2919937|Superiority||LSMean Difference|-1.18|Standard Error of the Mean|0.47||0.012|2-Sided|95.0|-2.11|-0.26|||Mixed Models Analysis|||HADS Depression.|
1588268|NCT03334422|2919937|Superiority||LSMean Difference|-0.71|Standard Error of the Mean|0.49||0.143|2-Sided|95.0|-1.67|0.24|||Mixed Models Analysis|||HADS Depression.|
1588269|NCT03334422|2919937|Superiority||LSMean Difference|-0.5|Standard Error of the Mean|0.51||0.321|2-Sided|95.0|-1.5|0.49|||Mixed Models Analysis|||HADS Depression.|
1588270|NCT03334422|2919937|Superiority||LSMean Difference|-1.3|Standard Error of the Mean|0.47||0.006|2-Sided|95.0|-2.23|-0.38|||Mixed Models Analysis|||HADS Anxiety.|
1588271|NCT03334422|2919937|Superiority||LSMean Difference|-0.93|Standard Error of the Mean|0.49||0.06|2-Sided|95.0|-1.89|0.04|||Mixed Models Analysis|||HADS Anxiety.|
1588272|NCT03334422|2919937|Superiority||LSMean Difference|-0.94|Standard Error of the Mean|0.51||0.067|2-Sided|95.0|-1.95|0.07|||Mixed Models Analysis|||HADS Anxiety.|
1588273|NCT03334422|2919938|Superiority||LSMean Difference|-0.69|Standard Error of the Mean|0.16|<|0.001|2-Sided|95.0|-1.0|-0.38|||Mixed Models Analysis||||
1588274|NCT03334422|2919938|Superiority||LSMean Difference|-0.61|Standard Error of the Mean|0.17|<|0.001|2-Sided|95.0|-0.94|-0.28|||Mixed Models Analysis||||
1588275|NCT03334422|2919938|Superiority||LSMean Difference|-0.27|Standard Error of the Mean|0.17|<|0.13|2-Sided|95.0|-0.61|0.08|||Mixed Models Analysis||||
1588276|NCT03334422|2919939|Superiority||LSMean Difference|-6.07|Standard Error of the Mean|1.21|<|0.001|2-Sided|95.0|-8.47|-3.68|||Mixed Models Analysis||||
1588277|NCT03334422|2919939|Superiority||LSMean Difference|-5.58|Standard Error of the Mean|1.27|<|0.001|2-Sided|95.0|-8.07|-3.08|||Mixed Models Analysis||||
1588278|NCT03334422|2919939|Superiority||LSMean Difference|-2.36|Standard Error of the Mean|1.32|<|0.075|2-Sided|95.0|-4.97|0.24|||Mixed Models Analysis||||
1588279|NCT03334422|2919940|Superiority||LSMean Difference|-30.28|Standard Error of the Mean|7.63|<|0.001|2-Sided|95.0|-45.29|-15.27|||Mixed Models Analysis||||
1588280|NCT03334422|2919940|Superiority||LSMean Difference|-30.66|Standard Error of the Mean|8.11|<|0.001|2-Sided|95.0|-46.62|-14.7|||Mixed Models Analysis||||
1588281|NCT03334422|2919940|Superiority||LSMean Difference|-14.8|Standard Error of the Mean|8.46|<|0.081|2-Sided|95.0|-31.45|1.85|||Mixed Models Analysis||||
1588282|NCT03334422|2919941|Superiority|||||||0.383|||||||Fisher Exact||||
1588283|NCT03334422|2919941|Superiority|||||||1|||||||Fisher Exact||||
1588284|NCT03334422|2919941|Superiority|||||||0.189|||||||Fisher Exact||||
1588285|NCT03334422|2919942|Superiority||LSMean Difference|-11.16|Standard Error of the Mean|2.98|<|0.001|2-Sided|95.0|-17.03|-5.3|||Mixed Models Analysis||||
1588286|NCT03334422|2919942|Superiority||LSMean Difference|-9.3|Standard Error of the Mean|3.1|<|0.003|2-Sided|95.0|-15.42|-3.18|||Mixed Models Analysis||||
1588287|NCT03334422|2919942|Superiority||LSMean Difference|-6.16|Standard Error of the Mean|3.23|<|0.058|2-Sided|95.0|-12.53|0.21|||Mixed Models Analysis||||
1588288|NCT03334422|2919943|Superiority||Odds Ratio (OR)|3.89||||0.044|2-Sided|95.0|1.04|14.57|||Regression, Logistic||||
1588289|NCT03334422|2919943|Superiority||Odds Ratio (OR)|4.1||||0.042|2-Sided|95.0|1.05|16.03|||Mixed Models Analysis||||
1588290|NCT03334422|2919943|Superiority||Odds Ratio (OR)|2.55||||0.193|2-Sided|95.0|0.62|10.45|||Regression, Logistic||||
1588292|NCT03334422|2919944|Superiority||LSMean Difference|-14.48|Standard Error of the Mean|3.47|<|0.001|2-Sided|95.0|-21.32|-7.63|||Mixed Models Analysis||||
1588293|NCT03334422|2919944|Superiority||LSMean Difference|-6.88|Standard Error of the Mean|3.63|<|0.059|2-Sided|95.0|-14.03|0.28|||Mixed Models Analysis||||
1588294|NCT03334422|2919945|Superiority||Odds Ratio (OR)|2.68||||0.123|2-Sided|95.0|0.77|9.37|||Regression, Logistic||||
1588295|NCT03334422|2919945|Superiority||Odds Ratio (OR)|2.56||||0.142|2-Sided|95.0|0.73|8.95|||Regression, Logistic||||
1588296|NCT03334422|2919945|Superiority||Odds Ratio (OR)|1.57||||0.528|2-Sided|95.0|0.39|6.31|||Regression, Logistic||||
1588297|NCT03334422|2919946|Superiority||Odds Ratio (OR)|3.15|||<|0.001|2-Sided|95.0|1.8|5.51|||Regression, Logistic||||
1588298|NCT03334422|2919946|Superiority||Odds Ratio (OR)|2.91|||<|0.001|2-Sided|95.0|1.65|5.11|||Regression, Logistic||||
1588299|NCT03334422|2919946|Superiority||Odds Ratio (OR)|1.67|||<|0.094|2-Sided|95.0|0.92|3.04|||Regression, Logistic||||
1588300|NCT03334422|2919947|Superiority||Mean Difference (Net)|-1.62|Standard Error of the Mean|0.38|<|0.001|2-Sided|95.0|-2.37|-0.87|||Mixed Models Analysis||||
1588301|NCT03334422|2919947|Superiority||Mean Difference (Net)|-1.75|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-2.54|-0.96|||Mixed Models Analysis||||
1588302|NCT03334422|2919947|Superiority||Mean Difference (Net)|-0.23|Standard Error of the Mean|0.41|<|0.58|2-Sided|95.0|-1.05|0.59|||Mixed Models Analysis||||
1588303|NCT03334422|2919948|Superiority||Mean Difference (Net)|-0.55|Standard Error of the Mean|0.15|<|0.001|2-Sided|95.0|-0.84|-0.26|||Mixed Models Analysis||||
1588304|NCT03334422|2919948|Superiority||Mean Difference (Net)|-0.38|Standard Error of the Mean|0.15|<|0.011|2-Sided|95.0|-0.68|-0.09|||Mixed Models Analysis||||
1588305|NCT03334422|2919948|Superiority||Mean Difference (Net)|-0.27|Standard Error of the Mean|0.15|<|0.074|2-Sided|95.0|-0.57|0.03|||Mixed Models Analysis||||
1588306|NCT03334422|2919949|Superiority||Odds Ratio (OR)|4.91|||<|0.001|2-Sided|95.0|2.22|10.86|||Regression, Logistic||||
1588307|NCT03334422|2919949|Superiority||Odds Ratio (OR)|3.64|||<|0.002|2-Sided|95.0|1.6|8.27|||Regression, Logistic||||
1588308|NCT03334422|2919949|Superiority||Odds Ratio (OR)|1.41|||<|0.505|2-Sided|95.0|0.51|3.87|||Regression, Logistic||||
1588309|NCT03334422|2919950|Superiority||Odds Ratio (OR)|7.4|||<|0.001|2-Sided|95.0|2.51|21.83|||Regression, Logistic||||
1588310|NCT03334422|2919950|Superiority||Odds Ratio (OR)|4.95|||<|0.006|2-Sided|95.0|1.58|15.49|||Regression, Logistic||||
1588311|NCT03334422|2919950|Superiority||Odds Ratio (OR)|2.9|||<|0.086|2-Sided|95.0|0.86|9.76|||Regression, Logistic||||
1588312|NCT03334422|2919951|Superiority||Mean Difference (Net)|-25.97|Standard Error of the Mean|6.24|<|0.001|2-Sided|95.0|-38.29|-13.65|||Mixed Models Analysis||||
1588313|NCT03334422|2919951|Superiority||Mean Difference (Net)|-25.89|Standard Error of the Mean|6.54|<|0.001|2-Sided|95.0|-38.78|-12.99|||Mixed Models Analysis||||
1588314|NCT03334422|2919951|Superiority||Mean Difference (Net)|-12.76|Standard Error of the Mean|6.81|<|0.062|2-Sided|95.0|-26.19|0.66|||Mixed Models Analysis||||
1588315|NCT03334422|2919952|Superiority||Odds Ratio (OR)|6.2|||<|0.001|2-Sided|95.0|2.42|15.91|||Regression, Logistic||||
1588316|NCT03334422|2919952|Superiority||Odds Ratio (OR)|3.87|||<|0.007|2-Sided|95.0|1.44|10.41|||Regression, Logistic||||
1588317|NCT03334422|2919952|Superiority||Odds Ratio (OR)|2.8|||<|0.053|2-Sided|95.0|0.99|7.97|||Regression, Logistic||||
1588318|NCT03334422|2919953|Superiority||Odds Ratio (OR)|4.41|||<|0.001|2-Sided|95.0|2.22|8.76|||Regression, Logistic||||
1588319|NCT03334422|2919953|Superiority||Odds Ratio (OR)|3.49|||<|0.001|2-Sided|95.0|1.73|7.04|||Regression, Logistic||||
1588320|NCT03334422|2919953|Superiority||Odds Ratio (OR)|2.35|||<|0.024|2-Sided|95.0|1.12|4.93|||Regression, Logistic||||
1588321|NCT03334422|2919954|Superiority||Odds Ratio (OR)|2.13||||0.085|2-Sided|95.0|0.9|5.02|||Regression, Logistic||||
1588322|NCT03334422|2919955|Superiority||Odds Ratio (OR)|3.64||||0.001|2-Sided|95.0|1.64|8.05|||Regression, Logistic||||
1588323|NCT03334422|2919955|Superiority||Odds Ratio (OR)|2.58||||0.026|2-Sided|95.0|1.12|5.92|||Regression, Logistic||||
1588324|NCT03334396|2919956|Superiority||Odds Ratio (OR)|4.72||||0.002|2-Sided|95.0|1.78|12.55|||Regression, Logistic||||
1588325|NCT03334396|2919956|Superiority||Odds Ratio (OR)|4.08||||0.006|2-Sided|95.0|1.5|11.12|||Regression, Logistic||||
1588326|NCT03334396|2919956|Superiority||Odds Ratio (OR)|1.38||||0.603|2-Sided|95.0|0.41|4.71|||Regression, Logistic||||
1588327|NCT03334396|2919957|Superiority||Mean Difference (Final Values)|7.05|Standard Error of the Mean|2.95||0.017|2-Sided|95.0|1.25|12.86|||Mixed Models Analysis|||EQ-5D-5L VAS Score|
1588328|NCT03334396|2919957|Superiority||Mean Difference (Final Values)|1.34|Standard Error of the Mean|3.13||0.668|2-Sided|95.0|-4.81|7.5|||Mixed Models Analysis|||EQ-5D-5L VAS Score|
1588329|NCT03334396|2919957|Superiority||Mean Difference (Final Values)|2.97|Standard Error of the Mean|3.21||0.356|2-Sided|95.0|-3.36|9.3|||Mixed Models Analysis|||EQ-5D-5L VAS Score|
1588330|NCT03334396|2919958|Superiority||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.03|<|0.001|2-Sided|95.0|0.06|0.16|||Mixed Models Analysis|||Health State Index Score (UK algorithm)|
1588331|NCT03334396|2919958|Superiority||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.03|<|0.059|2-Sided|95.0|0.0|0.11|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)|
1588332|NCT03334396|2919958|Superiority||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.03|<|0.046|2-Sided|95.0|0.0|0.11|||Mixed Models Analysis|||Health State Index Score (UK Algorithm)|
1588333|NCT03334396|2919958|Superiority||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.02|<|0.001|2-Sided|95.0|0.04|0.12|||Mixed Models Analysis|||Health State Index Score (US algorithm)|
1588334|NCT03334396|2919958|Superiority||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.02|<|0.06|2-Sided|95.0|0.0|0.08|||Mixed Models Analysis|||Health State Index Score (US algorithm)|
1588335|NCT03334396|2919958|Superiority||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.02|<|0.061|2-Sided|95.0|0.0|0.08|||Mixed Models Analysis|||Health State Index Score (US algorithm)|
1588336|NCT03334396|2919959|Superiority||Mean Difference (Final Values)|-16.52|Standard Error of the Mean|3.11|<|0.001|2-Sided|95.0|-22.64|-10.41|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline|
1588337|NCT03334396|2919959|Superiority||Mean Difference (Final Values)|-5.13|Standard Error of the Mean|3.31|<|0.122|2-Sided|95.0|-11.65|1.39|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline|
1588338|NCT03334396|2919959|Superiority||Mean Difference (Final Values)|-7.31|Standard Error of the Mean|3.36|<|0.03|2-Sided|95.0|-13.93|-0.7|||Mixed Models Analysis|||Percentage of Activity Impairment Change from Baseline|
1588339|NCT03334396|2919959|Superiority||Mean Difference (Final Values)|-11.28|Standard Error of the Mean|4.34|<|0.01|2-Sided|95.0|-19.84|-2.72|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline|
1588340|NCT03334396|2919959|Superiority||Mean Difference (Final Values)|-6.49|Standard Error of the Mean|4.76|<|0.175|2-Sided|95.0|-15.89|2.91|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline|
1588341|NCT03334396|2919959|Superiority||Mean Difference (Final Values)|-8.66|Standard Error of the Mean|4.67|<|0.066|2-Sided|95.0|-17.89|0.57|||Mixed Models Analysis|||Work Productivity Loss (Percentage Overall Work Impairment/Absenteeism Plus Presenteeism) Change from Baseline|
1588342|NCT03334396|2919959|Superiority||Mean Difference (Final Values)|-12.28|Standard Error of the Mean|3.9|<|0.002|2-Sided|95.0|-19.97|-4.59|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline|
1588343|NCT03334396|2919959|Superiority||Mean Difference (Final Values)|-8.64|Standard Error of the Mean|4.28|<|0.045|2-Sided|95.0|-17.09|-0.19|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline|
1588344|NCT03334396|2919959|Superiority||Mean Difference (Final Values)|-6.86|Standard Error of the Mean|4.19|<|0.104|2-Sided|95.0|-15.13|1.41|||Mixed Models Analysis|||Percentage of Presenteeism (Reduced Productivity While at Work) Change from Baseline|
1588345|NCT03334396|2919959|Superiority||Mean Difference (Final Values)|-3.4|Standard Error of the Mean|2.49|<|0.174|2-Sided|95.0|-8.32|1.52|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline|
1588346|NCT03334396|2919959|Superiority||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|2.76|<|0.898|2-Sided|95.0|-5.81|5.1|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline|
1588347|NCT03334396|2919959|Superiority||Mean Difference (Final Values)|-4.05|Standard Error of the Mean|2.7|<|0.136|2-Sided|95.0|-9.39|1.29|||Mixed Models Analysis|||Percentage of Absenteeism Change from Baseline|
1588348|NCT03334396|2919960|Superiority||Mean Difference (Final Values)|-4.3|Standard Error of the Mean|0.82|<|0.001|2-Sided|95.0|-5.91|-2.69|||Mixed Models Analysis||||
1588349|NCT03334396|2919960|Superiority||Mean Difference (Final Values)|-1.84|Standard Error of the Mean|0.87|<|0.036|2-Sided|95.0|-3.56|-0.12|||Mixed Models Analysis||||
1588350|NCT03334396|2919960|Superiority||Mean Difference (Final Values)|-2.17|Standard Error of the Mean|0.89|<|0.015|2-Sided|95.0|-3.92|-0.42|||Mixed Models Analysis||||
1588351|NCT03334396|2919961|Superiority||Mean Difference (Final Values)|-1.14|Standard Error of the Mean|0.39||0.004|2-Sided|95.0|-1.91|-0.37|||Mixed Models Analysis|||HADS Depression|
1588352|NCT03334396|2919961|Superiority||Mean Difference (Final Values)|-1.03|Standard Error of the Mean|0.42||0.014|2-Sided|95.0|-1.85|-0.22|||Mixed Models Analysis|||HADS Depression|
1588353|NCT03334396|2919961|Superiority||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|0.43||0.113|2-Sided|95.0|-1.51|0.16|||Mixed Models Analysis|||HADS Depression|
1588354|NCT03334396|2919961|Superiority||Mean Difference (Final Values)|-1.15|Standard Error of the Mean|0.4||0.004|2-Sided|95.0|-1.93|-0.36|||Mixed Models Analysis|||HADS Anxiety|
1588355|NCT03334396|2919961|Superiority||Mean Difference (Final Values)|-0.93|Standard Error of the Mean|0.42||0.029|2-Sided|95.0|-1.77|-0.1|||Mixed Models Analysis|||HADS Anxiety|
1588356|NCT03334396|2919961|Superiority||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.43||0.305|2-Sided|95.0|-1.3|0.41|||Mixed Models Analysis|||HADS Anxiety|
1588357|NCT03334396|2919962|Superiority||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-0.73|-0.19|||Mixed Models Analysis||||
1588358|NCT03334396|2919962|Superiority||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.15|<|0.066|2-Sided|95.0|-0.56|0.02|||Mixed Models Analysis||||
1588359|NCT03334396|2919962|Superiority||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.15|<|0.069|2-Sided|95.0|-0.56|0.02|||Mixed Models Analysis||||
1588360|NCT03334396|2919963|Superiority||Mean Difference (Final Values)|-5.16|Standard Error of the Mean|1.1|<|0.001|2-Sided|95.0|-7.33|-2.99|||Mixed Models Analysis||||
1588361|NCT03334396|2919963|Superiority||Mean Difference (Final Values)|-3.58|Standard Error of the Mean|1.17|<|0.003|2-Sided|95.0|-5.89|-1.27|||Mixed Models Analysis||||
1588362|NCT03334396|2919963|Superiority||Mean Difference (Final Values)|-2.63|Standard Error of the Mean|1.19|<|0.028|2-Sided|95.0|-4.98|-0.29|||Mixed Models Analysis||||
1588363|NCT03334396|2919964|Superiority||Mean Difference (Final Values)|-24.5|Standard Error of the Mean|6.71|<|0.001|2-Sided|95.0|-37.71|-11.3|||Mixed Models Analysis||||
1588364|NCT03334396|2919964|Superiority||Mean Difference (Final Values)|-17.39|Standard Error of the Mean|7.13|<|0.015|2-Sided|95.0|-31.43|-3.35|||Mixed Models Analysis||||
1588365|NCT03334396|2919964|Superiority||Mean Difference (Final Values)|-19.25|Standard Error of the Mean|7.33|<|0.009|2-Sided|95.0|-33.69|-4.81|||Mixed Models Analysis||||
1588366|NCT03334396|2919965|Superiority|||||||0.782|||||||Fisher Exact||||
1588367|NCT03334396|2919965|Superiority|||||||0.799|||||||Fisher Exact||||
1588368|NCT03334396|2919965|Superiority|||||||0.067|||||||Fisher Exact||||
1588369|NCT03334396|2919966|Superiority||Mean Difference (Final Values)|-11.16|Standard Deviation|2.63|<|0.001|2-Sided|95.0|-16.33|-5.98|||Mixed Models Analysis||||
1588370|NCT03334396|2919966|Superiority||Mean Difference (Final Values)|-5.34|Standard Error of the Mean|2.8|<|0.058|2-Sided|95.0|-10.86|0.18|||Mixed Models Analysis||||
1588371|NCT03334396|2919966|Superiority||Mean Difference (Final Values)|-5.99|Standard Error of the Mean|2.88|<|0.039|2-Sided|95.0|-11.67|-0.31|||Mixed Models Analysis||||
1589901|NCT03233308|2923207|Other||||||<|0.0687|||||||t-test, 1 sided|||Mean change from baseline -EVP|
1588375|NCT03334396|2919968|Superiority||Mean Difference (Final Values)|-14.79|Standard Error of the Mean|2.88|<|0.001|2-Sided|95.0|-20.46|-9.13|||Mixed Models Analysis||||
1588376|NCT03334396|2919968|Superiority||Mean Difference (Final Values)|-7.97|Standard Error of the Mean|3.07|<|0.01|2-Sided|95.0|-14.01|-1.92|||Mixed Models Analysis||||
1588377|NCT03334396|2919968|Superiority||Mean Difference (Final Values)|-5.34|Standard Error of the Mean|3.17|<|0.093|2-Sided|95.0|-11.57|0.9|||Mixed Models Analysis||||
1588378|NCT03334396|2919969|Superiority||Odds Ratio (OR)|1.94||||0.441|2-Sided|95.0|0.36|10.41|||Regression, Logistic||||
1588379|NCT03334396|2919969|Superiority||Odds Ratio (OR)|2.89||||0.182|2-Sided|95.0|0.61|13.75|||Regression, Logistic||||
1588380|NCT03334396|2919969|Superiority||Odds Ratio (OR)|1.98||||0.424|2-Sided|95.0|0.37|10.63|||Regression, Logistic||||
1588381|NCT03334396|2919970|Superiority||Mean Difference (Final Values)|4.18|||<|0.001|2-Sided|95.0|2.51|6.96|||Regression, Logistic||||
1588382|NCT03334396|2919970|Superiority||Mean Difference (Final Values)|2.44|||<|0.001|2-Sided|95.0|1.44|4.14|||Regression, Logistic||||
1588383|NCT03334396|2919970|Superiority||Odds Ratio (OR)|1.9|||<|0.019|2-Sided|95.0|1.11|3.25|||Regression, Logistic||||
1588384|NCT03334396|2919971|Superiority||Mean Difference (Final Values)|-1.09||||0.002|2-Sided|95.0|-1.79|-0.39|||Mixed Models Analysis||||
1588385|NCT03334396|2919971|Superiority||Mean Difference (Final Values)|-0.74||||0.051|2-Sided|95.0|-1.48|0.0|||Mixed Models Analysis||||
1588386|NCT03334396|2919971|Superiority||Mean Difference (Final Values)|-1.08||||0.005|2-Sided|95.0|-1.84|-0.32|||Mixed Models Analysis||||
1588387|NCT03334396|2919972|Superiority||Mean Difference (Final Values)|-0.58||||0.006|2-Sided|95.0|-1.0|-0.17|||Mixed Models Analysis||||
1588388|NCT03334396|2919972|Superiority||Mean Difference (Final Values)|-0.21||||0.352|2-Sided|95.0|-0.65|0.23|||Mixed Models Analysis||||
1588389|NCT03334396|2919972|Superiority||Mean Difference (Final Values)|-0.37||||0.103|2-Sided|95.0|-0.82|0.08|||Mixed Models Analysis||||
1588390|NCT03334396|2919973|Superiority||Odds Ratio (OR)|3.62|||<|0.001|2-Sided|95.0|1.82|7.18|||Regression, Logistic||||
1588391|NCT03334396|2919973|Superiority||Odds Ratio (OR)|1.73|||<|0.169|2-Sided|95.0|0.79|3.77|||Regression, Logistic||||
1588392|NCT03334396|2919973|Superiority||Odds Ratio (OR)|1.6|||<|0.246|2-Sided|95.0|0.72|3.56|||Regression, Logistic||||
1588393|NCT03334396|2919974|Superiority||Odds Ratio (OR)|8.76|||<|0.001|2-Sided|95.0|2.68|28.58|||Regression, Logistic||||
1588394|NCT03334396|2919974|Superiority||Odds Ratio (OR)|6.14|||<|0.004|2-Sided|95.0|1.79|20.99|||Regression, Logistic||||
1588395|NCT03334396|2919974|Superiority||Odds Ratio (OR)|4.28|||<|0.025|2-Sided|95.0|1.2|15.24|||Regression, Logistic||||
1588396|NCT03334396|2919975|Superiority||Mean Difference (Final Values)|-24.54|Standard Error of the Mean|5.23|<|0.001|2-Sided|95.0|-34.84|-14.24|||Mixed Models Analysis||||
1588397|NCT03334396|2919975|Superiority||Mean Difference (Final Values)|-17.07|Standard Error of the Mean|5.57|<|0.002|2-Sided|95.0|-28.05|-6.1|||Mixed Models Analysis||||
1588398|NCT03334396|2919975|Superiority||Mean Difference (Final Values)|-13.4|Standard Error of the Mean|5.78|<|0.021|2-Sided|95.0|-24.77|-2.03|||Mixed Models Analysis||||
1588399|NCT03334396|2919976|Superiority||Odds Ratio (OR)|4.13|||<|0.001|2-Sided|95.0|1.91|8.91|||Regression, Logistic||||
1588400|NCT03334396|2919976|Superiority||Odds Ratio (OR)|2.5|||<|0.029|2-Sided|95.0|1.1|5.7|||Regression, Logistic||||
1588401|NCT03334396|2919976|Superiority||Odds Ratio (OR)|1.73|||<|0.21|2-Sided|95.0|0.74|4.05|||Regression, Logistic||||
1588402|NCT03334396|2919977|Superiority||Odds Ratio (OR)|3.72|||<|0.001|2-Sided|95.0|2.01|6.89|||Regression, Logistic||||
1588403|NCT03334396|2919977|Superiority||Odds Ratio (OR)|2.46|||<|0.006|2-Sided|95.0|1.29|4.67|||Regression, Logistic||||
1588404|NCT03334396|2919977|Superiority||Odds Ratio (OR)|2.03|||<|0.032|2-Sided|95.0|1.06|3.88|||Regression, Logistic||||
1588405|NCT03334396|2919978|Superiority||Odds Ratio (OR)|2.72||||0.014|2-Sided|95.0|1.23|6.01|||Regression, Logistic||||
1588406|NCT03334396|2919979|Superiority||Odds Ratio (OR)|4.1|||<|0.001|2-Sided|95.0|1.93|8.7|||Regression, Logistic||||
1588407|NCT03334396|2919979|Superiority||Odds Ratio (OR)|2.61|||<|0.02|2-Sided|95.0|1.17|5.84|||Regression, Logistic||||
1588408|NCT03334214|2919980|Superiority|||||||0.933|||||||ANOVA||||
1588409|NCT03334214|2919981|Superiority|||||||0.2|||||||Van Elteren test|||Insulin|
1588410|NCT03334214|2919981|Superiority|||||||0.267|||||||Van Elteren test|||HOMA-IR|
1588411|NCT03334214|2919981|Superiority|||||||0.902|||||||ANOVA|||FPG|
1588412|NCT03334214|2919982|Superiority|||||||0.698|||||||ANOVA|||VLDL-C|
1588413|NCT03334214|2919982|Superiority|||||||0.619|||||||ANOVA|||Triglycerides|
1588414|NCT03334214|2919982|Superiority|||||||0.555|||||||ANOVA|||Non-HDL|
1588415|NCT03334214|2919982|Superiority|||||||0.463|||||||ANOVA|||LDL-C|
1588416|NCT03334214|2919982|Superiority|||||||0.717|||||||ANOVA|||HDL|
1588417|NCT03334214|2919982|Superiority|||||||0.716|||||||ANOVA|||ApoB|
1588418|NCT03334214|2919982|Superiority|||||||0.682|||||||ANOVA|||Total Cholesterol|
1588419|NCT03334214|2919983|Superiority|||||||0.183|||||||ANOVA||||
1588420|NCT03334214|2919984|Superiority|||||||0.0774|||||||Cochran-Mantel-Haenszel|The p-value is obtained using Cochran–Mantel–Haenszel (CMH) test stratified by the baseline liver fat stratum (<20%, ≥20%) stratification factor.|||
1588421|NCT03334214|2919985|Superiority|||||||0.024|||||||ANOVA||||
1588422|NCT03334214|2919988|Superiority|||||||0.026|||||||ANOVA||||
1588423|NCT03334214|2919989|Superiority|||||||0.003|||||||ANOVA||||
1588424|NCT03333876|2919994|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Each group was compared to baseline.|
1588444|NCT03329573|2920139|Equivalence|The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.024|||||2-Sided|90.0|0.952|1.101|||||||
1599045|NCT02858401|2938155|Other|||||||1|||||||Fisher Exact||||
1588425|NCT03331835|2920044|Superiority|The endpoint was analysed by using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.|Mean Difference (Net)|-1.72||||0.028|2-Sided|95.0|-3.24|-0.19|||Mixed Models Analysis||||
1588426|NCT03331835|2920045|Superiority|Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (<=100 kg, > 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.|Risk Difference (RD)|40.95|||<|0.001|2-Sided|95.0|28.75|53.16|||Cochran-Mantel-Haenszel||||
1588427|NCT03331835|2920046|Superiority||Mean Difference (Net)|-2.57||||0.004|2-Sided|95.0|-4.32|-0.82|||Mixed Models Analysis|||The endpoint is analysed by using mixed model for repeated measurements (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups are defined as randomised treatment.|
1588428|NCT03331835|2920047|Superiority||Mean Difference (Final Values)|-4.92|||<|0.001|2-Sided|95.0|-6.31|-3.53|||ANCOVA|||The AUC was analysed using analysis of covariance (ANCOVA) with treatment group, baseline weight group, and the baseline PSI total score as explanatory variables. Treatment groups are defined as randomised treatment.|
1588429|NCT03331835|2920051|Superiority||Mean Difference (Net)|-8.91|||<|0.001|2-Sided|95.0|-13.0|-4.81|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.|
1588430|NCT03331835|2920052|Superiority||Mean Difference (Net)|-16.36|||<|0.001|2-Sided|95.0|-23.03|-9.68|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.|
1588431|NCT03331835|2920053|Superiority||Mean Difference (Net)|-3.08|||<|0.001|2-Sided|95.0|-4.83|-1.33|||Mixed Models Analysis|||The endpoint was analysed using mixed model for repeated measures (MMRM) model including treatment group, week, interaction between treatment and time, baseline value, and baseline weight group as fixed factors. Within participant covariance was estimated by an unstructured covariance matrix. Treatment groups were defined as randomised treatment.|
1588432|NCT03331835|2920054|Superiority||Risk Difference (RD)|31.43|||<|0.001|2-Sided|95.0|20.76|42.1|||Cochran-Mantel-Haenszel|||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, > 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.|
1588433|NCT03331835|2920055|Superiority||Risk Difference (RD)|43.81|||<|0.001|2-Sided|95.0|31.78|55.84|||Cochran-Mantel-Haenszel|||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, > 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.|
1588434|NCT03331835|2920056|Superiority||Risk Difference (RD)|44.76|||<|0.001|2-Sided|95.0|32.81|56.71|||Cochran-Mantel-Haenszel|95% CI and p-value are derived from CMH analysis stratified by weight group at baseline (≤100 kg, > 100 kg)||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, > 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.|
1588435|NCT03331835|2920057|Superiority||Risk Difference (RD)|42.86|||<|0.001|2-Sided|95.0|30.93|54.79|||Cochran-Mantel-Haenszel|95% CI and p-value are derived from CMH analysis stratified by weight group at baseline (≤100 kg, > 100 kg).||Estimated risk difference, 95% CI and p-value are derived from Cochran-Mantel-Haenszel (CMH) analysis stratified by weight group at baseline (≤100 kg, > 100 kg). Non-responder Imputation (NRI) was used to impute missing data. Treatment groups were defined as randomised treatment.|
1588436|NCT03330275|2920080|Equivalence|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Mean Difference (Final Values)|4.7|Standard Error of the Mean|7.93|||2-Sided|95.0|-11.4|20.7|||||Mean difference was calculated as Test – Control 1||
1588437|NCT03330275|2920081|Equivalence|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|0.76|||||2-Sided|95.0|0.33|1.74|||||Odds Ratio was calculated as Test over Control 1||
1588438|NCT03330275|2920082|Equivalence|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Mean Difference (Final Values)|17.8|Standard Error of the Mean|5.29|||2-Sided|95.0|7.1|28.5|||||Mean difference was calculated as Test – Control 1||
1588439|NCT03330275|2920083|Equivalence|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|0.98|||||2-Sided|95.0|0.82|1.16|||||Odds ratio was calculated as Test over Control1||
1588440|NCT03330275|2920084|Equivalence|Equivalence was concluded if 0 was contained in the 95% confidence interval.|Odds Ratio (OR)|3.162|||||2-Sided|95.0|0.442|22.604|||||Odds ratio was calculated as Test over Control 1||
1588441|NCT03330275|2920085|Non-Inferiority|A non-inferiority margin of 0.1 logMAR was used. Non-inferiority was concluded if the upper limit was below 0.1.|Mean Difference (Final Values)|-0.028|Standard Error of the Mean|0.0076|||2-Sided|95.0|-0.043|-0.012|||||Mean difference was calculated as Test – Control 1||
1588442|NCT03330275|2920086|Non-Inferiority|A non-inferiority margin of -0.25 was used. Non-inferioirty was concluded if the lower limit of the 95% CI was above 0.25.|Mean Difference (Final Values)|0.069|Standard Error of the Mean|0.0574|||2-Sided|95.0|-0.045|0.183|||||Mean difference was calculated as Test – Control 1|It was calculated that a total of 24 participants was required to show that the Test lens is non-inferior to the control 1 lens with 80% power. Sample size for this study was based on night driving only.|
1588443|NCT03329573|2920138|Equivalence|The two formulations were considered to be bioequivalent if the 90% confidence interval of Cmax for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.02|||||2-Sided|90.0|0.968|1.074|||||||
1588445|NCT03329573|2920140|Equivalence|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|0.996|||||2-Sided|90.0|0.949|1.044|||||||
1588446|NCT03329573|2920141|Equivalence|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-t) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.064|||||2-Sided|90.0|1.01|1.12|||||||
1588447|NCT03329573|2920142|Equivalence|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|0.996|||||2-Sided|90.0|0.947|1.047|||||||
1588448|NCT03329573|2920143|Equivalence|The two formulations were considered to be bioequivalent if the 90% confidence interval of AUC(0-infinity) for difference between both treatments fall in the range of 0.80-1.25.|Ratio of Geometrical Mean|1.059|||||2-Sided|90.0|1.006|1.115|||||||
1588449|NCT03328208|2920160|Superiority||Mean Difference (Final Values)|0.038|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1588450|NCT03328208|2920161|Superiority||Mean Difference (Final Values)|0.724|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1588451|NCT03327051|2920201|Other|An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p<0.05.|||||>|0.99|||||||ANOVA|Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis||Within group difference between week 0 and week 4 was analyzed.|
1588452|NCT03327051|2920201|Other|An increase in relative abundance of VSL3 bacterial strains at week 4 compared to week 0 (baseline) is considered significant if p<0.05.|||||>|0.04|||||||ANOVA|Two-way ANOVA with Bonferroni post-test was used for multi-variable analysis||Within group difference between week 0 and week 4 was analyzed.|
1588453|NCT03325881|2920263|Superiority||Difference in LS mean|-0.1|Standard Error of the Mean|0.2||0.597|2-Sided|95.0|-0.5|0.3|||Mixed-effects model for repeated measure|||Number of participants with SHP465 was compared with placebo using the mixed effects model for repeated measures (MMRM) that includes treatment group, nominal visit, age group,interaction of the treatment group with the visit as factors, baseline CGI-S as a covariate and an adjustment for the interaction of the baseline CGI-S with the visit.|
1588454|NCT03325881|2920264|Superiority||Difference in LS Mean|-1.9|Standard Error of the Mean|2.48||0.451|2-Sided|95.0|-6.8|3.1|||Mixed-effects model for repeated measure|||Number of participants with SHP465 was compared with placebo using the linear mixed-effects model for repeated measures (MMRM) that included treatment group, nominal visit, age group, interaction of the treatment group with the visits as factors, baseline ADHD-RS5 total score as a covariate and an adjustment for the interaction of the baseline ADHD-RS-5 Total Score with the visit.|
1588455|NCT03325673|2920265|Superiority|||||||0.072|||||||t-test, 2 sided||||
1588456|NCT03325673|2920266|Superiority|||||||0.488|||||||t-test, 2 sided||||
1588457|NCT03325673|2920267|Superiority|||||||0.152|||||||t-test, 2 sided|||End of Day|
1588458|NCT03325673|2920267|Superiority|||||||0.235|||||||t-test, 2 sided|||After 2 hours|
1588459|NCT03325673|2920267|Superiority|||||||0.468|||||||t-test, 2 sided|||Insertion|
1588460|NCT03325673|2920268|Superiority|||||||0.116|||||||Independent t-test||||
1588461|NCT03323736|2920269|Superiority||||||<|0.0001||||||Pre-specified threshold for superiority was >85%, at alpha = 0.025.|mid-P method for single proportion|||The Anesthesia Effectiveness endpoint would be successfully met if the percentage of subjects with successful anesthesia was greater than (superior to) 85% (by subject), at a significance level of 0.025 (p<0.025).|
1588462|NCT03323736|2920270|Superiority||||||<|0.0001||||||Pre-specified threshold for superiority was >88%, at alpha = 0.025.|mid-P method for single proportion|||Tube Retention endpoint would be successfully met if the percentage of subjects with retained tubes was greater than (superior to) 88% (by subject), at a significance level of 0.025 (p<0.025).|
1588463|NCT03323736|2920271|Superiority||||||<|0.0001||||||Pre-specified threshold for superiority was >80%, at alpha = 0.025.|mid-P method for single proportion|||Tube Patency endpoint would be successfully met if the percentage of subjects with patent tubes was greater than (superior to) 80% (by subject), at a significance level of 0.025 (p<0.025).|
1588464|NCT03323736|2920272|Superiority|Comparison of mean tube placement FPS-R score to a performance goal of 4.2.||||||0.0072||||||Mean FPS-R score hypothesized to be less than (superior to) a performance goal of 4.2, at a significance level of 0.025 (p<0.025).|t-test, 1 sided||||
1588465|NCT03323736|2920273|Superiority|The Procedural Success endpoint would be successfully met if the lower bound of the 95% Credible Interval (lower limit 0.82) exceeded the 68% success rate performance goal.|Credible Interval|0.89|||||2-Sided|95.0|0.82|0.93||||||Procedural success rate was compared to the performance goal of 68% using a Bayesian Hierarchical model.|
1588466|NCT03323736|2920273|Superiority|The Procedural Success endpoint would be successfully met if the lower bound of the 95% Credible Interval (lower limit 0.80) exceeded the 68% success rate performance goal.|Credible Interval|0.86|||||2-Sided|95.0|0.8|0.91||||||Procedural success rate was compared to the performance goal of 68% using a Bayesian Hierarchical model.|
1588467|NCT03322930|2920288|Other||||||<|0.05||||||calculated from data|t-test, 2 sided||||mean sensitivity for group; Coefficient of Repeatability for multiple tests per patient
1588468|NCT03322566|2920292|Other||Hazard Ratio (HR)|1.9||||0.96272|2-Sided|95.0|0.93|3.9||One-sided p-value based on log-rank test stratified by TPS (<50% vs >=50%) and predominant histology (squamous vs non-squamous), because of small sample size, the strata ‘TPS >= 50% Non-squamous’ and 'TPS >= 50% Squamous’ were combined into one.|Regression, Cox|Efron’s method of tie handling|||
1588469|NCT03322566|2920293|Other||Hazard Ratio (HR)|1.47||||0.94305|2-Sided|95.0|0.91|2.36||One-sided p-value based on log-rank test stratified by TPS (<50% vs >=50%) and predominant histology (squamous vs non-squamous), because of small sample size, the strata ‘TPS >= 50% Non-squamous’ and 'TPS >= 50% Squamous’ were combined into one.|Regression, Cox|Efron’s method of tie handling|||
1588470|NCT03322566|2920294|Superiority||Difference in Percentages|-18.5||||0.9948|2-Sided|95.0|-32.0|-4.3||One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % > 0.|Stratified Miettinen and Nurminen method||Stratified by PD-L1 TPS ( <50% vs. >=50% ) and predominant tumor histology (squamous vs non-squamous);because of small sample size, the strata ‘TPS >= 50 percent Non-squamous’ and 'TPS >= 50% Squamous’ were combined into one stratum.||
1588471|NCT03322540|2920300|Superiority||Difference in Percentages|-6.5||||0.8|2-Sided|95.0|-21.5|8.7|||Stratified Miettinen and Nurminen method|One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % > 0.|Point estimate was assessed based on Miettinen & Nurminen method stratified by predominant tumor histology (squamous vs non-squamous).||
1588472|NCT03322514|2920301|Superiority|||||||0.7|||||||t-test, 2 sided|||baseline to 12 weeks|
1588473|NCT03322514|2920301|Superiority|||||||0.4|||||||t-test, 2 sided|||Baseline to 12 weeks|
1588474|NCT03322514|2920301|Superiority|||||||0.9|||||||ANOVA||||
1588475|NCT03322514|2920302|Superiority|||||||0.3|||||||t-test, 2 sided|||Baseline to 12 weeks|
1588476|NCT03322514|2920302|Superiority|||||||0.3|||||||t-test, 2 sided|||Baseline to 12 weeks|
1588477|NCT03322514|2920302|Superiority|||||||0.8|||||||ANOVA||||
1588478|NCT03322514|2920303|Superiority|||||||0.1|||||||t-test, 2 sided|||Baseline to 12 weeks|
1588479|NCT03322514|2920303|Superiority|||||||0.04|||||||t-test, 2 sided|||Baseline to 12 weeks|
1588480|NCT03322514|2920303|Superiority|||||||0.8|||||||t-test, 2 sided||||
1588481|NCT03322423|2920304|Superiority|Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.|LS Mean Estimate|46.4|Standard Error of the Mean|2.21|||2-Sided|95.0|42.1|50.8|||||||
1588482|NCT03322423|2920304|Superiority|Statistical superiority was concluded if the lower limit of the confidence intervals of the Test lens was above 32 CLUE points.|LS Mean Estimate|45.5|Standard Error of the Mean|2.19|||2-Sided|95.0|41.2|49.9|||||||
1588483|NCT03322423|2920305|Superiority|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.|LS Mean Estimate|0.141|Standard Error of the Mean|0.0147|||2-Sided|95.0|0.112|0.17|||||||
1588484|NCT03322423|2920305|Superiority|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.17 logMAR for near.|LS Mean Estimate|0.141|Standard Error of the Mean|0.0147|||2-Sided|95.0|0.112|0.17|||||||
1588485|NCT03322423|2920306|Superiority|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.|Least-Square Mean Estimate|-0.076|Standard Error of the Mean|0.0114|||2-Sided|95.0|-0.099|-0.054|||||||
1588486|NCT03322423|2920306|Superiority|Statistical superiority was concluded if the upper limit of the confidence intervals of the Test lens was below +0.01 logMAR for distance.|Least-Square Mean Estimate|-0.058|Standard Error of the Mean|0.0114|||2-Sided|95.0|-0.08|-0.035|||||||
1588487|NCT03321253|2920319|Other||||||<|0.01|||||||ANOVA||||
1588488|NCT03320941|2920321|Other|Dose Finding|Mean Difference (Final Values)|-5.66|Standard Error of the Mean|3.3512||0.096|2-Sided|95.0|-12.361|1.041|||ANCOVA|||T2DM|
1588489|NCT03320941|2920321|Other|Dose Finding|Mean Difference (Final Values)|-5.594|Standard Error of the Mean|3.4818||0.113|2-Sided|95.0|-12.556|1.368|||ANCOVA|||T2DM|
1588490|NCT03320941|2920321|Other|Dose Finding|Mean Difference (Final Values)|-0.826|Standard Error of the Mean|3.9906||0.837|2-Sided|95.0|-8.805|7.154|||ANCOVA|||T2DM|
1588491|NCT03320941|2920321|Other|Dose Finding|Mean Difference (Final Values)|-2.636|Standard Error of the Mean|3.8828||0.5|2-Sided|95.0|-10.4|5.128|||ANCOVA|||T2DM|
1588492|NCT03320941|2920321|Other|Dose Finding|Mean Difference (Final Values)|2.201|Standard Error of the Mean|3.6414||0.548|2-Sided|95.0|-5.113|9.515|||ANCOVA|||Dysglycemic|
1588493|NCT03320941|2920321|Other|Dose Finding|Mean Difference (Final Values)|-2.906|Standard Error of the Mean|3.6351||0.428|2-Sided|95.0|-10.207|4.396|||ANCOVA|||Dysglycemic|
1588494|NCT03320941|2920321|Other|Dose Finding|Mean Difference (Final Values)|-1.634|Standard Error of the Mean|4.1121||0.693|2-Sided|95.0|-9.893|6.625|||ANCOVA|||Dysglycemic|
1588495|NCT03320941|2920321|Other|Dose Finding|Mean Difference (Final Values)|-3.147|Standard Error of the Mean|4.1699||0.416|2-Sided|95.0|-11.792|4.959|||ANCOVA|||Dysglycemic|
1588496|NCT03320941|2920321|Other|Dose Finding|Mean Difference (Final Values)|-2.268|Standard Error of the Mean|2.4659||0.36|2-Sided|95.0|-7.152|2.616|||ANCOVA|||Overall Study|
1588497|NCT03320941|2920321|Other|Dose Finding|Mean Difference (Final Values)|-4.507|Standard Error of the Mean|2.5118||0.075|2-Sided|95.0|-9.482|0.468|||ANCOVA|||Overall Study|
1588498|NCT03320941|2920321|Other|Dose Finding|Mean Difference (Final Values)|-0.977|Standard Error of the Mean|2.859||0.733|2-Sided|95.0|-6.639|4.686|||ANCOVA|||Overall Study|
1588499|NCT03320941|2920321|Other|Dose Finding|Mean Difference (Final Values)|-3.086|Standard Error of the Mean|2.8326||0.278|2-Sided|95.0|-8.696|2.525|||ANCOVA|||Overall Study|
1588500|NCT03320941|2920322|Other|Dose Finding|Mean Difference (Final Values)|-7.591|Standard Error of the Mean|6.3822||0.239|2-Sided|95.0|-20.345|5.163|||ANCOVA|||T2DM|
1588501|NCT03320941|2920322|Other|Dose Finding|Mean Difference (Final Values)|-5.779|Standard Error of the Mean|6.6977||0.391|2-Sided|95.0|-19.164|7.605|||ANCOVA|||T2DM|
1588502|NCT03320941|2920322|Other|Dose Finding|Mean Difference (Final Values)|1.202|Standard Error of the Mean|7.5086||0.873|2-Sided|95.0|-13.802|16.207|||ANCOVA|||T2DM|
1588503|NCT03320941|2920322|Other|Dose Finding|Mean Difference (Final Values)|0.676|Standard Error of the Mean|7.2441||0.926|2-Sided|95.0|-13.8|15.152|||ANCOVA|||T2DM|
1588504|NCT03320941|2920322|Other|Dose Finding|Mean Difference (Final Values)|-6.943|Standard Error of the Mean|5.2191||0.189|2-Sided|95.0|-17.421|3.535|||ANCOVA|||Dysglycemic|
1588505|NCT03320941|2920322|Other|Dose Finding|Mean Difference (Final Values)|-5.587|Standard Error of the Mean|5.2598||0.293|2-Sided|95.0|-16.147|4.972|||ANCOVA|||Dysglycemic|
1588506|NCT03320941|2920322|Other|Dose Finding|Mean Difference (Final Values)|-6.048|Standard Error of the Mean|5.7919||0.301|2-Sided|95.0|-17.676|5.58|||ANCOVA|||Dysglycemic|
1588507|NCT03320941|2920322|Other|Dose Finding|Mean Difference (Final Values)|-1.142|Standard Error of the Mean|6.0033||0.85|2-Sided|95.0|-13.194|10.91|||ANCOVA|||Dysglycemic|
1588508|NCT03320941|2920322|Other|Dose Finding|Mean Difference (Final Values)|-7.403|Standard Error of the Mean|4.1637||0.078|2-Sided|95.0|-15.648|0.841|||ANCOVA|||Overall Study|
1588509|NCT03320941|2920322|Other|Dose Finding|Mean Difference (Final Values)|-5.236|Standard Error of the Mean|4.2623||0.222|2-Sided|95.0|-13.676|3.203|||ANCOVA|||Overall Study|
1589091|NCT03286218|2921190|Other||LS Mean Difference|19.1|||||2-Sided|90.0|14.5|23.8||||||Overall Drug Liking|
1588510|NCT03320941|2920322|Other|Dose Finding|Mean Difference (Final Values)|-1.883|Standard Error of the Mean|4.7545||0.693|2-Sided|95.0|-11.297|7.531|||ANCOVA|||Overall Study|
1588511|NCT03320941|2920322|Other|Dose Finding|Mean Difference (Final Values)|-0.19|Standard Error of the Mean|4.7535||0.968|2-Sided|95.0|-9.603|9.222|||ANCOVA|||Overall Study|
1588512|NCT03320941|2920323|Other|Dose Finding|Mean Difference (Final Values)|-0.792|Standard Error of the Mean|1.8889||0.676|2-Sided|95.0|-4.57|2.986|||ANCOVA|||T2DM|
1588513|NCT03320941|2920323|Other|Dose Finding|Mean Difference (Final Values)|-2.166|Standard Error of the Mean|1.9486||0.271|2-Sided|95.0|-6.064|1.732|||ANCOVA|||T2DM|
1588514|NCT03320941|2920323|Other|Dose Finding|Mean Difference (Final Values)|-0.024|Standard Error of the Mean|2.1453||0.991|2-Sided|95.0|-4.315|4.267|||ANCOVA|||T2DM|
1588515|NCT03320941|2920323|Other|Dose Finding|Mean Difference (Final Values)|0.605|Standard Error of the Mean|2.073||0.771|2-Sided|95.0|-3.541|4.752|||ANCOVA|||T2DM|
1588516|NCT03320941|2920323|Other|Dose Finding|Mean Difference (Final Values)|0.104|Standard Error of the Mean|0.4917||0.833|2-Sided|95.0|-0.884|1.092|||ANCOVA|||Dysglycemic|
1588517|NCT03320941|2920323|Other|Dose Finding|Mean Difference (Final Values)|0.352|Standard Error of the Mean|0.5029||0.487|2-Sided|95.0|-0.659|1.362|||ANCOVA|||Dysglycemic|
1588518|NCT03320941|2920323|Other|Dose Finding|Mean Difference (Final Values)|1.609|Standard Error of the Mean|0.5716||0.007|2-Sided|95.0|0.46|2.758|||ANCOVA|||Dysglycemic|
1588519|NCT03320941|2920323|Other|Dose Finding|Mean Difference (Final Values)|0.57|Standard Error of the Mean|0.563||0.317|2-Sided|95.0|-0.562|1.701|||ANCOVA|||Dysglycemic|
1588520|NCT03320941|2920323|Other|Dose Finding|Mean Difference (Final Values)|-0.374|Standard Error of the Mean|1.0303||0.717|2-Sided|95.0|-2.416|1.667|||ANCOVA|||Overall Study|
1588521|NCT03320941|2920323|Other|Dose Finding|Mean Difference (Final Values)|-1.048|Standard Error of the Mean|1.0479||0.319|2-Sided|95.0|-3.124|1.028|||ANCOVA|||Overall Study|
1588522|NCT03320941|2920323|Other|Dose Finding|Mean Difference (Final Values)|0.655|Standard Error of the Mean|1.1738||0.578|2-Sided|95.0|-1.67|2.98|||ANCOVA|||Overall Study|
1588523|NCT03320941|2920323|Other|Dose Finding|Mean Difference (Final Values)|0.654|Standard Error of the Mean|1.1543||0.572|2-Sided|95.0|-1.632|2.941|||ANCOVA|||Overall Study|
1588524|NCT03320941|2920324|Other|Dose Finding|Mean Difference (Final Values)|-1.991|Standard Error of the Mean|2.2659||0.383|2-Sided|95.0|-6.521|2.538|||ANCOVA|||T2DM|
1588525|NCT03320941|2920324|Other|Dose Finding|Mean Difference (Final Values)|-3.431|Standard Error of the Mean|2.3113||0.143|2-Sided|95.0|-8.051|1.19|||ANCOVA|||T2DM|
1588526|NCT03320941|2920324|Other|Dose Finding|Mean Difference (Final Values)|-0.877|Standard Error of the Mean|2.5906||0.736|2-Sided|95.0|-6.055|4.302|||ANCOVA|||T2DM|
1588527|NCT03320941|2920324|Other|Dose Finding|Mean Difference (Final Values)|-3.725|Standard Error of the Mean|2.518||0.144|2-Sided|95.0|-8.758|1.309|||ANCOVA|||T2DM|
1588528|NCT03320941|2920324|Other|Dose Finding|Mean Difference (Final Values)|0.206|Standard Error of the Mean|1.019||0.841|2-Sided|95.0|-1.842|2.253|||ANCOVA|||Dysglycemic|
1588529|NCT03320941|2920324|Other|Dose Finding|Mean Difference (Final Values)|1.155|Standard Error of the Mean|1.0371||0.271|2-Sided|95.0|-0.929|3.239|||ANCOVA|||Dysglycemic|
1588530|NCT03320941|2920324|Other|Dose Finding|Mean Difference (Final Values)|5.641|Standard Error of the Mean|1.1678|<|0.001|2-Sided|95.0|3.294|7.988|||ANCOVA|||Dysglycemic|
1588531|NCT03320941|2920324|Other|Dose Finding|Mean Difference (Final Values)|1.671|Standard Error of the Mean|1.1677|<|0.159|2-Sided|95.0|-0.676|4.017|||ANCOVA|||Dysglycemic|
1588532|NCT03320941|2920324|Other|Dose Finding|Mean Difference (Final Values)|-1.818|Standard Error of the Mean|1.6349|<|0.269|2-Sided|95.0|-5.056|1.421|||ANCOVA|||Overall Study|
1588533|NCT03320941|2920324|Other|Dose Finding|Mean Difference (Final Values)|-2.621|Standard Error of the Mean|1.6596|<|0.117|2-Sided|95.0|-5.908|0.666|||ANCOVA|||Overall Study|
1588534|NCT03320941|2920324|Other|Dose Finding|Mean Difference (Final Values)|1.289|Standard Error of the Mean|1.8741|<|0.493|2-Sided|95.0|-2.423|5.001|||ANCOVA|||Overall Study|
1588535|NCT03320941|2920324|Other|Dose Finding|Mean Difference (Final Values)|-0.556|Standard Error of the Mean|1.845|<|0.764|2-Sided|95.0|-4.21|3.098|||ANCOVA|||Overall Study|
1588536|NCT03320941|2920325|Other|Dose Finding|Mean Difference (Final Values)|-65.0|Standard Error of the Mean|12.15|<|0.001|2-Sided|95.0|-89.291|-40.713|||ANCOVA|||T2DM|
1588537|NCT03320941|2920325|Other|Dose Finding|Mean Difference (Final Values)|-61.8|Standard Error of the Mean|12.43|<|0.001|2-Sided|95.0|-86.627|-36.937|||ANCOVA|||T2DM|
1588538|NCT03320941|2920325|Other|Dose Finding|Mean Difference (Final Values)|-53.1|Standard Error of the Mean|13.93|<|0.001|2-Sided|95.0|-80.914|-25.251|||ANCOVA|||T2DM|
1588539|NCT03320941|2920325|Other|Dose Finding|Mean Difference (Final Values)|-47.5|Standard Error of the Mean|13.52|<|0.001|2-Sided|95.0|-74.493|-20.461|||ANCOVA|||T2DM|
1588540|NCT03320941|2920325|Other|Dose Finding|Mean Difference (Final Values)|-84.9|Standard Error of the Mean|21.03|<|0.001|2-Sided|95.0|-127.104|-42.669|||ANCOVA|||Dysglycemic|
1588541|NCT03320941|2920325|Other|Dose Finding|Mean Difference (Final Values)|-81.1|Standard Error of the Mean|21.04|<|0.001|2-Sided|95.0|-123.369|-38.883|||ANCOVA|||Dysglycemic|
1588542|NCT03320941|2920325|Other|Dose Finding|Mean Difference (Final Values)|-86.1|Standard Error of the Mean|24.01|<|0.001|2-Sided|95.0|-134.266|-37.874|||ANCOVA|||Dysglycemic|
1588543|NCT03320941|2920325|Other|Dose Finding|Mean Difference (Final Values)|-86.9|Standard Error of the Mean|24.35|<|0.001|2-Sided|95.0|-135.78|-38.013|||ANCOVA|||Dysglycemic|
1588544|NCT03320941|2920325|Other|Dose Finding|Mean Difference (Final Values)|-74.4|Standard Error of the Mean|11.47|<|0.001|2-Sided|95.0|-97.117|-51.704|||ANCOVA|||Overall Study|
1588545|NCT03320941|2920325|Other|Dose Finding|Mean Difference (Final Values)|-70.8|Standard Error of the Mean|11.67|<|0.001|2-Sided|95.0|-93.942|-47.735|||ANCOVA|||Overall Study|
1588546|NCT03320941|2920325|Other|Dose Finding|Mean Difference (Final Values)|-67.7|Standard Error of the Mean|13.21|<|0.001|2-Sided|95.0|-93.848|-41.542|||ANCOVA|||Overall Study|
1588547|NCT03320941|2920325|Other|Dose Finding|Mean Difference (Final Values)|-65.1|Standard Error of the Mean|13.03|<|0.001|2-Sided|95.0|-90.864|-39.251|||ANCOVA|||Overall Study|
1588548|NCT03320941|2920326|Other|Dose Finding|Mean Difference (Final Values)|103.135||||0.431|2-Sided|95.0|-157.287|363.556|||ANCOVA|||T2DM|
1588549|NCT03320941|2920326|Other|Dose Finding|Mean Difference (Final Values)|156.017||||0.252|2-Sided|95.0|-113.963|425.997|||ANCOVA|||T2DM|
1588550|NCT03320941|2920326|Other|Dose Finding|Mean Difference (Final Values)|287.328||||0.066|2-Sided|95.0|-19.533|594.19|||ANCOVA|||T2DM|
1588551|NCT03320941|2920326|Other|Dose Finding|Mean Difference (Final Values)|84.822||||0.591|2-Sided|95.0|-229.131|398.775|||ANCOVA|||T2DM|
1588552|NCT03320941|2920326|Other|Dose Finding|Mean Difference (Final Values)|-37.264||||0.607|2-Sided|95.0|-182.099|107.571|||ANCOVA|||Dysglycemic|
1588553|NCT03320941|2920326|Other|Dose Finding|Mean Difference (Final Values)|-30.447||||0.675|2-Sided|95.0|-175.796|114.902|||ANCOVA|||Dysglycemic|
1588554|NCT03320941|2920326|Other|Dose Finding|Mean Difference (Final Values)|12.891||||0.882|2-Sided|95.0|-160.215|185.996|||ANCOVA|||Dysglycemic|
1588555|NCT03320941|2920326|Other|Dose Finding|Mean Difference (Final Values)|22.879||||0.797|2-Sided|95.0|-155.244|201.003|||ANCOVA|||Dysglycemic|
1588556|NCT03320941|2920326|Other|Dose Finding|Mean Difference (Final Values)|37.733||||0.627|2-Sided|95.0|-115.58|191.045|||ANCOVA|||Overall Study|
1588557|NCT03320941|2920326|Other|Dose Finding|Mean Difference (Final Values)|69.062||||0.384|2-Sided|95.0|-87.493|225.617|||ANCOVA|||Overall Study|
1588558|NCT03320941|2920326|Other|Dose Finding|Mean Difference (Final Values)|162.273||||0.079|2-Sided|95.0|-19.326|343.871|||ANCOVA|||Overall Study|
1588559|NCT03320941|2920326|Other|Dose Finding|Mean Difference (Final Values)|44.82||||0.625|2-Sided|95.0|-136.644|226.284|||ANCOVA|||Overall Study|
1588560|NCT03320941|2920327|Other|Dose Finding|Mean Difference (Final Values)|3.86|Standard Error of the Mean|5.9073||0.516|2-Sided|95.0|-7.948|15.669|||ANCOVA|||T2DM|
1588561|NCT03320941|2920327|Other|Dose Finding|Mean Difference (Final Values)|-4.237|Standard Error of the Mean|6.23||0.499|2-Sided|95.0|-16.691|8.216|||ANCOVA|||T2DM|
1588562|NCT03320941|2920327|Other|Dose Finding|Mean Difference (Final Values)|-4.504|Standard Error of the Mean|6.8489||0.513|2-Sided|95.0|-18.195|9.187|||ANCOVA|||T2DM|
1588563|NCT03320941|2920327|Other|Dose Finding|Mean Difference (Final Values)|0.785|Standard Error of the Mean|6.6209||0.906|2-Sided|95.0|-12.45|14.02|||ANCOVA|||T2DM|
1588564|NCT03320941|2920327|Other|Dose Finding|Mean Difference (Final Values)|6.121|Standard Error of the Mean|7.5174||0.419|2-Sided|95.0|-8.986|21.228|||ANCOVA|||Dysglycemic|
1588565|NCT03320941|2920327|Other|Dose Finding|Mean Difference (Final Values)|6.572|Standard Error of the Mean|7.422||0.38|2-Sided|95.0|-8.343|21.487|||ANCOVA|||Dysglycemic|
1588566|NCT03320941|2920327|Other|Dose Finding|Mean Difference (Final Values)|-0.48|Standard Error of the Mean|9.2308||0.959|2-Sided|95.0|-19.03|18.07|||ANCOVA|||Dysglycemic|
1588567|NCT03320941|2920327|Other|Dose Finding|Mean Difference (Final Values)|0.928|Standard Error of the Mean|8.5585||0.914|2-Sided|95.0|-16.271|18.127|||ANCOVA|||Dysglycemic|
1588568|NCT03320941|2920327|Other|Dose Finding|Mean Difference (Final Values)|5.278|Standard Error of the Mean|4.6095||0.255|2-Sided|95.0|-3.852|14.407|||ANCOVA|||Overall Study|
1588569|NCT03320941|2920327|Other|Dose Finding|Mean Difference (Final Values)|0.588|Standard Error of the Mean|4.7125||0.901|2-Sided|95.0|-8.745|9.922|||ANCOVA|||Overall Study|
1588570|NCT03320941|2920327|Other|Dose Finding|Mean Difference (Final Values)|-1.812|Standard Error of the Mean|5.4301||0.739|2-Sided|95.0|-12.567|8.943|||ANCOVA|||Overall Study|
1588571|NCT03320941|2920327|Other|Dose Finding|Mean Difference (Final Values)|1.308|Standard Error of the Mean|5.2049||0.802|2-Sided|95.0|-9.001|11.617|||ANCOVA|||Overall Study|
1588572|NCT03320941|2920328|Other|Dose Finding|Mean Difference (Final Values)|2.913|Standard Error of the Mean|4.0035||0.47|2-Sided|95.0|-5.09|10.916|||ANCOVA|||T2DM|
1588573|NCT03320941|2920328|Other|Dose Finding|Mean Difference (Final Values)|-4.316|Standard Error of the Mean|4.0556||0.291|2-Sided|95.0|-12.423|3.791|||ANCOVA|||T2DM|
1588574|NCT03320941|2920328|Other|Dose Finding|Mean Difference (Final Values)|-2.019|Standard Error of the Mean|4.5491||0.659|2-Sided|95.0|-11.112|7.074|||ANCOVA|||T2DM|
1588575|NCT03320941|2920328|Other|Dose Finding|Mean Difference (Final Values)|5.563|Standard Error of the Mean|4.4636||0.217|2-Sided|95.0|-3.36|14.486|||ANCOVA|||T2DM|
1588576|NCT03320941|2920328|Other|Dose Finding|Mean Difference (Final Values)|4.182|Standard Error of the Mean|4.7627||0.384|2-Sided|95.0|-5.389|13.753|||ANCOVA|||Dysglycemic|
1588577|NCT03320941|2920328|Other|Dose Finding|Mean Difference (Final Values)|1.05|Standard Error of the Mean|4.7651||0.826|2-Sided|95.0|-8.525|10.626|||ANCOVA|||Dysglycemic|
1588578|NCT03320941|2920328|Other|Dose Finding|Mean Difference (Final Values)|4.659|Standard Error of the Mean|5.4845||0.4|2-Sided|95.0|-6.363|15.68|||ANCOVA|||Dysglycemic|
1588579|NCT03320941|2920328|Other|Dose Finding|Mean Difference (Final Values)|3.811|Standard Error of the Mean|5.4552||0.488|2-Sided|95.0|-7.152|14.774|||ANCOVA|||Dysglycemic|
1588580|NCT03320941|2920328|Other|Dose Finding|Mean Difference (Final Values)|3.566|Standard Error of the Mean|3.0079||0.238|2-Sided|95.0|-2.391|9.524|||ANCOVA|||Overall Study|
1588581|NCT03320941|2920328|Other|Dose Finding|Mean Difference (Final Values)|-1.799|Standard Error of the Mean|3.0432||0.556|2-Sided|95.0|-7.826|4.229|||ANCOVA|||Overall Study|
1588582|NCT03320941|2920328|Other|Dose Finding|Mean Difference (Final Values)|0.993|Standard Error of the Mean|3.4645||0.775|2-Sided|95.0|-5.869|7.855|||ANCOVA|||Overall Study|
1588583|NCT03320941|2920328|Other|Dose Finding|Mean Difference (Final Values)|4.954|Standard Error of the Mean|3.4006||0.148|2-Sided|95.0|-1.781|11.689|||ANCOVA|||Overall Study|
1588584|NCT03320941|2920329|Other|Dose Finding|Mean Difference (Final Values)|2.488|Standard Error of the Mean|4.1111||0.547|2-Sided|95.0|-5.73|10.706|||ANCOVA|||T2DM|
1588585|NCT03320941|2920329|Other|Dose Finding|Mean Difference (Final Values)|-0.975|Standard Error of the Mean|4.2883||0.821|2-Sided|95.0|-9.547|7.597|||ANCOVA|||T2DM|
1588586|NCT03320941|2920329|Other|Dose Finding|Mean Difference (Final Values)|-0.696|Standard Error of the Mean|4.7173||0.883|2-Sided|95.0|-10.126|8.734|||ANCOVA|||T2DM|
1588587|NCT03320941|2920329|Other|Dose Finding|Mean Difference (Final Values)|0.828|Standard Error of the Mean|4.5876||0.857|2-Sided|95.0|-8.342|9.999|||ANCOVA|||T2DM|
1588588|NCT03320941|2920329|Other|Dose Finding|Mean Difference (Final Values)|1.825|Standard Error of the Mean|5.197||0.727|2-Sided|95.0|-8.619|12.269|||ANCOVA|||Dysglycemic|
1590713|NCT03191552|2924337|Superiority|||||||0.08|||||||Kruskal-Wallis||||
1588589|NCT03320941|2920329|Other|Dose Finding|Mean Difference (Final Values)|7.832|Standard Error of the Mean|5.0946||0.131|2-Sided|95.0|-2.406|18.07|||ANCOVA|||Dysglycemic|
1588590|NCT03320941|2920329|Other|Dose Finding|Mean Difference (Final Values)|-2.458|Standard Error of the Mean|6.3493||0.7|2-Sided|95.0|-15.217|10.302|||ANCOVA|||Dysglycemic|
1588591|NCT03320941|2920329|Other|Dose Finding|Mean Difference (Final Values)|0.504|Standard Error of the Mean|5.8734||0.932|2-Sided|95.0|-11.299|12.307|||ANCOVA|||Dysglycemic|
1588592|NCT03320941|2920329|Other|Dose Finding|Mean Difference (Final Values)|2.546|Standard Error of the Mean|3.1859||0.426|2-Sided|95.0|-3.764|8.856|||ANCOVA|||Overall Study|
1588593|NCT03320941|2920329|Other|Dose Finding|Mean Difference (Final Values)|3.128|Standard Error of the Mean|3.2564||0.339|2-Sided|95.0|-3.322|9.578|||ANCOVA|||Overall Study|
1588594|NCT03320941|2920329|Other|Dose Finding|Mean Difference (Final Values)|-0.739|Standard Error of the Mean|3.7167||0.843|2-Sided|95.0|-8.1|6.623|||ANCOVA|||Overall Study|
1588595|NCT03320941|2920329|Other|Dose Finding|Mean Difference (Final Values)|0.955|Standard Error of the Mean|3.605||0.792|2-Sided|95.0|-6.185|8.095|||ANCOVA|||Overall Study|
1588596|NCT03320941|2920330|Other|Dose Finding|Mean Difference (Final Values)|-13.863|Standard Error of the Mean|21.2205||0.516|2-Sided|95.0|-56.283|28.556|||ANCOVA|||T2DM|
1588597|NCT03320941|2920330|Other|Dose Finding|Mean Difference (Final Values)|20.94|Standard Error of the Mean|22.0444||0.346|2-Sided|95.0|-23.126|65.007|||ANCOVA|||T2DM|
1588598|NCT03320941|2920330|Other|Dose Finding|Mean Difference (Final Values)|9.302|Standard Error of the Mean|24.422||0.705|2-Sided|95.0|-39.517|58.121|||ANCOVA|||T2DM|
1588599|NCT03320941|2920330|Other|Dose Finding|Mean Difference (Final Values)|-12.79|Standard Error of the Mean|24.3259||0.601|2-Sided|95.0|-61.417|35.836|||ANCOVA|||T2DM|
1588600|NCT03320941|2920330|Other|Dose Finding|Mean Difference (Final Values)|-6.901|Standard Error of the Mean|34.4309||0.842|2-Sided|95.0|-76.093|62.29|||ANCOVA|||Dysglycemic|
1588601|NCT03320941|2920330|Other|Dose Finding|Mean Difference (Final Values)|31.322|Standard Error of the Mean|33.855||0.359|2-Sided|95.0|-36.712|99.356|||ANCOVA|||Dysglycemic|
1588602|NCT03320941|2920330|Other|Dose Finding|Mean Difference (Final Values)|-22.948|Standard Error of the Mean|39.4994||0.564|2-Sided|95.0|-102.325|56.429|||ANCOVA|||Dysglycemic|
1588603|NCT03320941|2920330|Other|Dose Finding|Mean Difference (Final Values)|-22.115|Standard Error of the Mean|38.7858||0.571|2-Sided|95.0|-100.058|55.828|||ANCOVA|||Dysglycemic|
1588604|NCT03320941|2920330|Other|Dose Finding|Mean Difference (Final Values)|-12.094|Standard Error of the Mean|18.8076||0.521|2-Sided|95.0|-49.345|25.157|||ANCOVA|||Overall Study|
1588605|NCT03320941|2920330|Other|Dose Finding|Mean Difference (Final Values)|26.527|Standard Error of the Mean|19.1803||0.169|2-Sided|95.0|-11.462|64.516|||ANCOVA|||Overall Study|
1588606|NCT03320941|2920330|Other|Dose Finding|Mean Difference (Final Values)|-6.343|Standard Error of the Mean|21.6316||0.77|2-Sided|95.0|-49.187|36.501|||ANCOVA|||Overall Study|
1588607|NCT03320941|2920330|Other|Dose Finding|Mean Difference (Final Values)|-15.561|Standard Error of the Mean|21.4808||0.47|2-Sided|95.0|-58.106|26.985|||ANCOVA|||Overall Study|
1588608|NCT03320941|2920331|Other|Dose Finding|Mean Difference (Final Values)|-3.99|Standard Error of the Mean|2.31||0.089|2-Sided|95.0|-8.61|0.623|||ANCOVA|||T2DM|
1588609|NCT03320941|2920331|Other|Dose Finding|Mean Difference (Final Values)|-4.05|Standard Error of the Mean|2.388||0.095|2-Sided|95.0|-8.825|0.721|||ANCOVA|||T2DM|
1588610|NCT03320941|2920331|Other|Dose Finding|Mean Difference (Final Values)|-0.52|Standard Error of the Mean|2.669||0.846|2-Sided|95.0|-5.853|4.812|||ANCOVA|||T2DM|
1588611|NCT03320941|2920331|Other|Dose Finding|Mean Difference (Final Values)|-2.07|Standard Error of the Mean|2.599||0.428|2-Sided|95.0|-7.268|3.121|||ANCOVA|||T2DM|
1588612|NCT03320941|2920331|Other|Dose Finding|Mean Difference (Final Values)|0.05|Standard Error of the Mean|2.792||0.985|2-Sided|95.0|-5.552|5.657|||ANCOVA|||Dysglycemic|
1588613|NCT03320941|2920331|Other|Dose Finding|Mean Difference (Final Values)|1.84|Standard Error of the Mean|2.79||0.512|2-Sided|95.0|-3.758|7.444|||ANCOVA|||Dysglycemic|
1588614|NCT03320941|2920331|Other|Dose Finding|Mean Difference (Final Values)|-0.09|Standard Error of the Mean|3.23||0.978|2-Sided|95.0|-6.574|6.397|||ANCOVA|||Dysglycemic|
1588615|NCT03320941|2920331|Other|Dose Finding|Mean Difference (Final Values)|0.99|Standard Error of the Mean|3.2||0.758|2-Sided|95.0|-5.435|7.415|||ANCOVA|||Dysglycemic|
1588616|NCT03320941|2920331|Other|Dose Finding|Mean Difference (Final Values)|-2.11|Standard Error of the Mean|1.774||0.237|2-Sided|95.0|-5.622|1.402|||ANCOVA|||Overall Study|
1588617|NCT03320941|2920331|Other|Dose Finding|Mean Difference (Final Values)|-1.23|Standard Error of the Mean|1.807||0.496|2-Sided|95.0|-4.811|2.345|||ANCOVA|||Overall Study|
1588618|NCT03320941|2920331|Other|Dose Finding|Mean Difference (Final Values)|-0.42|Standard Error of the Mean|2.043||0.839|2-Sided|95.0|-4.462|3.63|||ANCOVA|||Overall Study|
1588619|NCT03320941|2920331|Other|Dose Finding|Mean Difference (Final Values)|-0.59|Standard Error of the Mean|2.013||0.769|2-Sided|95.0|-4.579|3.393|||ANCOVA|||Overall Study|
1588620|NCT03320941|2920332|Other|Dose Finding|Mean Difference (Final Values)|-5.23|Standard Error of the Mean|3.07||0.093|2-Sided|95.0|-11.367|0.905|||ANCOVA|||T2DM|
1588621|NCT03320941|2920332|Other|Dose Finding|Mean Difference (Final Values)|-4.87|Standard Error of the Mean|3.19||0.132|2-Sided|95.0|-11.24|1.508|||ANCOVA|||T2DM|
1588622|NCT03320941|2920332|Other|Dose Finding|Mean Difference (Final Values)|0.81|Standard Error of the Mean|3.563||0.821|2-Sided|95.0|-6.311|7.93|||ANCOVA|||T2DM|
1588623|NCT03320941|2920332|Other|Dose Finding|Mean Difference (Final Values)|-0.4|Standard Error of the Mean|3.461||0.909|2-Sided|95.0|-7.312|6.52|||ANCOVA|||T2DM|
1588624|NCT03320941|2920332|Other|Dose Finding|Mean Difference (Final Values)|2.92|Standard Error of the Mean|3.673||0.43|2-Sided|95.0|-4.454|10.292|||ANCOVA|||Dysglycemic|
1588625|NCT03320941|2920332|Other|Dose Finding|Mean Difference (Final Values)|3.52|Standard Error of the Mean|3.668||0.342|2-Sided|95.0|-3.848|10.88|||ANCOVA|||Dysglycemic|
1588626|NCT03320941|2920332|Other|Dose Finding|Mean Difference (Final Values)|0.0|Standard Error of the Mean|4.267||0.999|2-Sided|95.0|-8.571|8.563|||ANCOVA|||Dysglycemic|
1589092|NCT03286218|2921190|Other||LS Mean Difference|18.6|||||2-Sided|90.0|14.0|23.2||||||Overall Drug Liking|
1588627|NCT03320941|2920332|Other|Dose Finding|Mean Difference (Final Values)|1.31|Standard Error of the Mean|4.206||0.757|2-Sided|95.0|-7.138|9.749|||ANCOVA|||Dysglycemic|
1588628|NCT03320941|2920332|Other|Dose Finding|Mean Difference (Final Values)|-1.58|Standard Error of the Mean|2.387||0.508|2-Sided|95.0|-6.312|3.142|||ANCOVA|||Overall Study|
1588629|NCT03320941|2920332|Other|Dose Finding|Mean Difference (Final Values)|-1.0|Standard Error of the Mean|2.433||0.682|2-Sided|95.0|-5.817|3.82|||ANCOVA|||Overall Study|
1588630|NCT03320941|2920332|Other|Dose Finding|Mean Difference (Final Values)|0.24|Standard Error of the Mean|2.765||0.931|2-Sided|95.0|-5.235|5.716|||ANCOVA|||Overall Study|
1588631|NCT03320941|2920332|Other|Dose Finding|Mean Difference (Final Values)|0.46|Standard Error of the Mean|2.707||0.865|2-Sided|95.0|-4.898|5.822|||ANCOVA|||Overall Study|
1588632|NCT03320941|2920333|Other|Dose Finding|Mean Difference (Final Values)|-1.298|Standard Error of the Mean|0.2855|<|0.001|2-Sided|95.0|-1.869|-0.728|||ANCOVA|||T2DM|
1588633|NCT03320941|2920333|Other|Dose Finding|Mean Difference (Final Values)|-1.065|Standard Error of the Mean|0.2946|<|0.001|2-Sided|95.0|-1.654|-0.476|||ANCOVA|||T2DM|
1588634|NCT03320941|2920333|Other|Dose Finding|Mean Difference (Final Values)|-1.032|Standard Error of the Mean|0.3296|<|0.003|2-Sided|95.0|-1.691|-0.373|||ANCOVA|||T2DM|
1588635|NCT03320941|2920333|Other|Dose Finding|Mean Difference (Final Values)|-0.527|Standard Error of the Mean|0.3249|<|0.11|2-Sided|95.0|-1.176|0.122|||ANCOVA|||T2DM|
1588636|NCT03320941|2920333|Other|Dose Finding|Mean Difference (Final Values)|-0.256|Standard Error of the Mean|0.1787|<|0.159|2-Sided|95.0|-0.615|0.103|||ANCOVA|||Dysglycemic|
1588637|NCT03320941|2920333|Other|Dose Finding|Mean Difference (Final Values)|-0.045|Standard Error of the Mean|0.1791|<|0.803|2-Sided|95.0|-0.405|0.315|||ANCOVA|||Dysglycemic|
1588638|NCT03320941|2920333|Other|Dose Finding|Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.2068|<|0.665|2-Sided|95.0|-0.325|0.506|||ANCOVA|||Dysglycemic|
1588639|NCT03320941|2920333|Other|Dose Finding|Mean Difference (Final Values)|0.218|Standard Error of the Mean|0.2054|<|0.293|2-Sided|95.0|-0.194|0.631|||ANCOVA|||Dysglycemic|
1588640|NCT03320941|2920333|Other|Dose Finding|Mean Difference (Final Values)|-0.826|Standard Error of the Mean|0.1831|<|0.001|2-Sided|95.0|-1.188|-0.463|||ANCOVA|||Overall Study|
1588641|NCT03320941|2920333|Other|Dose Finding|Mean Difference (Final Values)|-0.587|Standard Error of the Mean|0.1866|<|0.002|2-Sided|95.0|-0.956|-0.217|||ANCOVA|||Overall Study|
1588642|NCT03320941|2920333|Other|Dose Finding|Mean Difference (Final Values)|-0.505|Standard Error of the Mean|0.2115|<|0.018|2-Sided|95.0|-0.924|-0.087|||ANCOVA|||Overall Study|
1588643|NCT03320941|2920333|Other|Dose Finding|Mean Difference (Final Values)|-0.174|Standard Error of the Mean|0.2094|<|0.408|2-Sided|95.0|-0.589|0.241|||ANCOVA|||Overall Study|
1588644|NCT03320941|2920334|Other|Dose Finding|Mean Difference (Final Values)|-0.526|Standard Error of the Mean|0.1217|<|0.001|2-Sided|95.0|-0.769|-0.282|||ANCOVA|||T2DM|
1588645|NCT03320941|2920334|Other|Dose Finding|Mean Difference (Final Values)|-0.409|Standard Error of the Mean|0.1253|<|0.002|2-Sided|95.0|-0.66|-0.159|||ANCOVA|||T2DM|
1588646|NCT03320941|2920334|Other|Dose Finding|Mean Difference (Final Values)|-0.399|Standard Error of the Mean|0.1411|<|0.006|2-Sided|95.0|-0.681|-0.117|||ANCOVA|||T2DM|
1588647|NCT03320941|2920334|Other|Dose Finding|Mean Difference (Final Values)|-0.313|Standard Error of the Mean|0.1399|<|0.029|2-Sided|95.0|-0.592|-0.033|||ANCOVA|||T2DM|
1588648|NCT03320941|2920334|Other|Dose Finding|Mean Difference (Final Values)|-0.113|Standard Error of the Mean|0.0673|<|0.1|2-Sided|95.0|-0.248|0.022|||ANCOVA|||Dysglycemic|
1588649|NCT03320941|2920334|Other|Dose Finding|Mean Difference (Final Values)|-0.146|Standard Error of the Mean|0.0673|<|0.035|2-Sided|95.0|-0.282|-0.011|||ANCOVA|||Dysglycemic|
1588650|NCT03320941|2920334|Other|Dose Finding|Mean Difference (Final Values)|-0.134|Standard Error of the Mean|0.0774|<|0.088|2-Sided|95.0|-0.29|0.021|||ANCOVA|||Dysglycemic|
1588651|NCT03320941|2920334|Other|Dose Finding|Mean Difference (Final Values)|-0.089|Standard Error of the Mean|0.0775|<|0.258|2-Sided|95.0|-0.245|0.067|||ANCOVA|||Dysglycemic|
1588652|NCT03320941|2920334|Other|Dose Finding|Mean Difference (Final Values)|-0.338|Standard Error of the Mean|0.0747|<|0.001|2-Sided|95.0|-0.486|-0.19|||ANCOVA|||Overall Study|
1588653|NCT03320941|2920334|Other|Dose Finding|Mean Difference (Final Values)|-0.287|Standard Error of the Mean|0.076|<|0.001|2-Sided|95.0|-0.437|-0.136|||ANCOVA|||Overall Study|
1588654|NCT03320941|2920334|Other|Dose Finding|Mean Difference (Final Values)|-0.276|Standard Error of the Mean|0.0863|<|0.002|2-Sided|95.0|-0.447|-0.105|||ANCOVA|||Overall Study|
1588655|NCT03320941|2920334|Other|Dose Finding|Mean Difference (Final Values)|-0.206|Standard Error of the Mean|0.086|<|0.018|2-Sided|95.0|-0.376|-0.035|||ANCOVA|||Overall Study|
1588656|NCT03320941|2920335|Other|Dose Finding|Mean Difference (Final Values)|-1.69|Standard Error of the Mean|1.139||0.143|2-Sided|95.0|-3.964|0.588|||ANCOVA|||T2DM|
1588657|NCT03320941|2920335|Other|Dose Finding|Mean Difference (Final Values)|-0.71|Standard Error of the Mean|1.188||0.552|2-Sided|95.0|-3.084|1.663|||ANCOVA|||T2DM|
1588658|NCT03320941|2920335|Other|Dose Finding|Mean Difference (Final Values)|0.8|Standard Error of the Mean|1.304||0.544|2-Sided|95.0|-1.809|3.401|||ANCOVA|||T2DM|
1588659|NCT03320941|2920335|Other|Dose Finding|Mean Difference (Final Values)|-0.03|Standard Error of the Mean|1.292||0.982|2-Sided|95.0|-2.611|2.552|||ANCOVA|||T2DM|
1588660|NCT03320941|2920335|Other|Dose Finding|Mean Difference (Final Values)|-1.81|Standard Error of the Mean|1.346||0.184|2-Sided|95.0|-4.515|0.888|||ANCOVA|||Dysglycemic|
1588661|NCT03320941|2920335|Other|Dose Finding|Mean Difference (Final Values)|-1.66|Standard Error of the Mean|1.325||0.215|2-Sided|95.0|-4.322|0.996|||ANCOVA|||Dysglycemic|
1588662|NCT03320941|2920335|Other|Dose Finding|Mean Difference (Final Values)|-4.08|Standard Error of the Mean|1.534||0.011|2-Sided|95.0|-7.156|-0.994|||ANCOVA|||Dysglycemic|
1588663|NCT03320941|2920335|Other|Dose Finding|Mean Difference (Final Values)|-2.36|Standard Error of the Mean|1.534||0.13|2-Sided|95.0|-5.444|0.717|||ANCOVA|||Dysglycemic|
1588664|NCT03320941|2920335|Other|Dose Finding|Mean Difference (Final Values)|-1.74|Standard Error of the Mean|0.89||0.053|2-Sided|95.0|-3.401|0.022|||ANCOVA|||Overall Study|
1588665|NCT03320941|2920335|Other|Dose Finding|Mean Difference (Final Values)|-1.28|Standard Error of the Mean|0.902||0.158|2-Sided|95.0|-3.069|0.504|||ANCOVA|||Overall Study|
1588666|NCT03320941|2920335|Other|Dose Finding|Mean Difference (Final Values)|-1.26|Standard Error of the Mean|1.013||0.216|2-Sided|95.0|-3.265|0.747|||ANCOVA|||Overall Study|
1588667|NCT03320941|2920335|Other|Dose Finding|Mean Difference (Final Values)|-1.1|Standard Error of the Mean|1.011||0.278|2-Sided|95.0|-3.104|0.9|||ANCOVA|||Overall Study|
1588668|NCT03320941|2920336|Other|Dose Finding|Median Difference (Final Values)|-4.37|||||2-Sided|95.0|-5.93|-2.79||||||T2DM|
1588669|NCT03320941|2920336|Other|Dose Finding|Mean Difference (Final Values)|-3.64|||||2-Sided|95.0|-5.2|-1.52||||||T2DM|
1588670|NCT03320941|2920336|Other|Dose Finding|Mean Difference (Final Values)|-2.88|||||2-Sided|95.0|-4.37|-0.61||||||T2DM|
1588671|NCT03320941|2920336|Other|Dose Finding|Mean Difference (Final Values)|-1.96|||||2-Sided|95.0|-3.12|-0.15||||||T2DM|
1588672|NCT03320941|2920336|Other|Dose Finding|Mean Difference (Final Values)|-3.51|||||2-Sided|95.0|-4.93|-1.74||||||Dysglycemic|
1588673|NCT03320941|2920336|Other|Dose Finding|Mean Difference (Final Values)|-3.33|||||2-Sided|95.0|-4.71|-1.82||||||Dysglycemic|
1588674|NCT03320941|2920336|Other|Dose Finding|Mean Difference (Final Values)|-2.98|||||2-Sided|95.0|-4.56|-1.46||||||Dysglycemic|
1588675|NCT03320941|2920336|Other|Dose Finding|Median Difference (Final Values)|-1.84|||||2-Sided|95.0|-3.56|-0.19||||||Dysglycemic|
1588676|NCT03320941|2920337|Other|Dose Finding|Odds Ratio (OR)|37.949||||0.003|2-Sided|95.0|3.477|414.232|||Regression, Logistic|||>= 3% Percent decrease in body weight (T2DM)|
1588677|NCT03320941|2920337|Other|Dose Finding|Odds Ratio (OR)|29.312||||0.006|2-Sided|95.0|2.665|322.412|||Regression, Logistic|||>= 3% Percent decrease in body weight (T2DM)|
1588678|NCT03320941|2920337|Other|Dose Finding|Odds Ratio, log|9.112||||0.075|2-Sided|95.0|0.799|103.872|||Regression, Logistic|||>= 3% Percent decrease in body weight (T2DM)|
1588679|NCT03320941|2920337|Other|Dose Finding|Odds Ratio (OR)|3.59||||0.336|2-Sided|95.0|0.265|48.552|||Regression, Logistic|||>= 3% Percent decrease in body weight (T2DM)|
1588680|NCT03320941|2920337|Other|Dose Finding|Odds Ratio (OR)|9.456||||0.062|2-Sided|95.0|0.891|100.292|||Regression, Logistic|||>= 3% Percent decrease in body weight (Dysglycemic)|
1588681|NCT03320941|2920337|Other|Dose Finding|Odds Ratio (OR)|10.333||||0.059|2-Sided|95.0|0.914|116.82|||Regression, Logistic|||>= 3% Percent decrease in body weight (Dysglycemic)|
1588682|NCT03320941|2920337|Other|Dose Finding|Odds Ratio (OR)|28.26||||0.012|2-Sided|95.0|2.066|386.473|||Regression, Logistic|||>= 3% Percent decrease in body weight (Dysglycemic)|
1588683|NCT03320941|2920337|Other|Dose Finding|Odds Ratio (OR)|1.697||||0.727|2-Sided|95.0|0.087|33.006|||Regression, Logistic|||>= 3% Percent decrease in body weight (Dysglycemic)|
1588684|NCT03320941|2920337|Other|Dose Finding|Odds Ratio (OR)|16.813|||<|0.001|2-Sided|95.0|3.362|84.085|||Regression, Logistic|||>= 3% Percent decrease in body weight|
1588685|NCT03320941|2920337|Other|Dose Finding|Odds Ratio (OR)|12.708|||<|0.002|2-Sided|95.0|2.511|64.32|||Regression, Logistic|||>= 3% Percent decrease in body weight|
1588686|NCT03320941|2920337|Other|Dose Finding|Odds Ratio (OR)|15.78|||<|0.002|2-Sided|95.0|2.844|87.552|||Regression, Logistic|||>= 3% Percent decrease in body weight|
1588687|NCT03320941|2920337|Other|Dose Finding|Odds Ratio (OR)|2.299|||<|0.39|2-Sided|95.0|0.344|15.35|||Regression, Logistic|||>= 3% Percent decrease in body weight|
1588688|NCT03320941|2920338|Other|Dose Finding|Mean Difference (Net)|-3.91|||||2-Sided|95.0|-5.01|-2.77|||||||
1588689|NCT03320941|2920338|Other|Dose Finding|Mean Difference (Net)|-3.54|||||2-Sided|95.0|-4.54|-2.26|||||||
1588690|NCT03320941|2920338|Other|Dose Finding|Mean Difference (Net)|-3.0|||||2-Sided|95.0|-4.15|-1.7|||||||
1588691|NCT03320941|2920338|Other|Dose Finding|Mean Difference (Net)|-1.99|||||2-Sided|95.0|-2.92|-0.21|||||||
1588692|NCT03319719|2920354|Superiority||Mean Difference (Net)|-2.88|||<|0.0001|2-Sided|95.0|-3.42|-2.33||p-value from paired two-sided t-tests of no difference between test and control groups.|t-test, 2 sided||||
1588693|NCT03319173|2920370|Other||Estimate|1.122|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|1.096|1.149|||Regression, Linear||||
1588694|NCT03319173|2920371|Other||Estimate|0.93|Standard Error of the Mean|0.008|<|0.0001|2-Sided|95.0|0.91|0.94|||Regression, Linear||||
1588695|NCT03319173|2920372|Other||Estimate|1.037|||<|0.0001|2-Sided|95.0|1.025|1.049|||Regression, Linear||||
1588696|NCT03319173|2920373|Other||Estimate|1.13|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|1.104|1.156|||Regression, Linear||||
1588697|NCT03319173|2920374|Other||Estimate|0.51|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.47|0.56|||Regression, Linear||||
1588698|NCT03319173|2920375|Other||Estimate|0.75|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.71|0.8|||Regression, Linear||||
1588699|NCT03319173|2920376|Other||Estimate|0.87|Standard Error of the Mean|0.01|<|0.0001|2-Sided|95.0|0.85|0.88|||Regression, Linear||||
1588700|NCT03319173|2920377|Other||Estimate|0.87|Standard Error of the Mean|0.01|<|0.0001|2-Sided|95.0|0.85|0.88|||Regression, Linear||||
1588701|NCT03319173|2920378|Other||Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.3|0.37|||Estimate||||
1588702|NCT03319173|2920379|Other||Estimate|0.75|Standard Error of the Mean|0.01|<|0.0001|2-Sided|95.0|0.72|0.78|||Regression, Linear||||
1588703|NCT03319173|2920380|Other||Mean Difference (Final Values)|0.44|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.4|0.49|||Estimate||||
1588704|NCT03319173|2920381|Other||Estimate|0.44|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.4|0.49|||Regression, Linear||||
1588705|NCT03319173|2920382|Other||Estimate|0.514|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.47|0.56|||Regression, Linear||||
1588706|NCT03319173|2920383|Other||Estimate|0.46|Standard Error of the Mean|0.03|<|0.0001|2-Sided|95.0|0.41|0.52|||Regression, Linear||||
1588707|NCT03319173|2920384|Other||Estimate|0.35|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.31|0.39|||Regression, Linear||||
1588708|NCT03319173|2920385|Other||Mean Difference (Final Values)|8.24|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|7.79|8.7|||Regression, Linear||||
1588709|NCT03317431|2920396|Superiority||||||<|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with Ac-a-tubulin expression.|
1588710|NCT03317431|2920397|Superiority||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DDC expression.|
1588711|NCT03317431|2920398|Superiority||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with TH expression.|
1588712|NCT03317431|2920399|Superiority||||||>|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DRD2 expression.|
1588713|NCT03317431|2920400|Superiority||||||<|0.01|||||||Regression, Linear|||Analysis the relationship between the duration of mechanical ventilation with DRD1 expression.|
1588714|NCT03316378|2920420|Superiority||Mean Difference (Final Values)|0.05||||1|2-Sided|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time|
1588715|NCT03316378|2920420|Superiority||Mean Difference (Final Values)|0.15||||1|2-Sided|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups|
1588716|NCT03316378|2920421|Superiority||Mean Difference (Final Values)|1.6||||0.012|2-Sided|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time|
1588717|NCT03316378|2920421|Superiority||Mean Difference (Final Values)|6.9|||<|0.001|2-Sided|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups|
1588718|NCT03316378|2920422|Superiority||Mean Difference (Final Values)|31.7||||0.08|2-Sided|||||P-value adjusted for multiple comparisons|ANOVA|||Specific Aim 2: Effect of time|
1588719|NCT03316378|2920422|Superiority||Mean Difference (Final Values)|73.8||||0.44|2-Sided|||||Adjusted for multiple comparisons|ANOVA|||Specific Aim 1: Between groups|
1588720|NCT03316131|2920423|Other||Geometric mean ratio|0.99|||||2-Sided|90.0|0.94|1.04||||||Treatment A/Treatment B, for M8|
1588721|NCT03316131|2920423|Other||Geometric mean ratio|0.96||||||90.0|0.9|1.02||||||Treatment A/Treatment B, for M1|
1588722|NCT03316131|2920423|Other||Geometric mean ratio|1.06|||||2-Sided|90.0|1.0|1.13||||||Treatment A/Treatment B, for Verinurad|
1588723|NCT03316131|2920427|Other||Geometric mean ratio|0.99|||||2-Sided|90.0|0.94|1.04||||||Treatment A/Treatment B, for M8|
1588724|NCT03316131|2920427|Other||Geometric mean ratio|0.96|||||2-Sided|90.0|0.9|1.02||||||Treatment A/Treatment B, for M1|
1588725|NCT03316131|2920427|Other||Geometric mean ratio|1.06|||||2-Sided|90.0|1.0|1.13||||||Treatment A/Treatment B, for Verinurad|
1588726|NCT03316131|2920428|Other||Geometric mean ratio|0.99|||||2-Sided|90.0|0.91|1.08||||||Treatment A/Treatment B, for M8|
1588727|NCT03316131|2920428|Other||Geometric mean ratio|0.97|||||2-Sided|90.0|0.88|1.07||||||Treatment A/Treatment B, for M1|
1588728|NCT03316131|2920428|Other||Geometric mean ratio|1.14|||||2-Sided|90.0|1.03|1.25||||||Treatment A/Treatment B, for Verinurad|
1588729|NCT03316131|2920429|Other||Mean Difference (Net)|0.28|||||2-Sided|95.0|-8.67|9.22|||||||
1588730|NCT03315780|2920432|Superiority||Mean Difference (Final Values)|-15.39||||0.7475|2-Sided|95.0|-118.35|87.57|||Mixed Models Analysis||||
1588731|NCT03315780|2920433|Superiority||Mean Difference (Final Values)|-9.36||||0.08|2-Sided|95.0|-20.16|1.43|||Mixed Models Analysis||||
1588732|NCT03315780|2920434|Superiority||Mean Difference (Final Values)|3.72||||0.0263|2-Sided|95.0|0.63|6.81|||Mixed Models Analysis||||
1588733|NCT03315780|2920435|Superiority||Mean Difference (Final Values)|27.46||||0.01|2-Sided|95.0|8.05|46.87|||Mixed Models Analysis||||
1588734|NCT03315780|2920438|Superiority||Mean Difference (Final Values)|-254.02|||<|0.0001|2-Sided|95.0|-337.76|-170.28|||Mixed Models Analysis||||
1588735|NCT03315286|2920483|Superiority|||||||0.0002|||||||t-test, 2 sided|||6 month data is reported here|
1588736|NCT03315286|2920483|Superiority|||||||0.07|||||||t-test, 2 sided|||baseline data is reported here|
1588737|NCT03315286|2920484|Superiority|||||||0.4|||||||t-test, 2 sided|||6 month data is reported here|
1588738|NCT03315286|2920484|Superiority|||||||0.2|||||||t-test, 2 sided|||Baseline data is reported here.|
1588739|NCT03315286|2920485|Superiority|||||||0.3|||||||t-test, 2 sided|||6 month data is reported here|
1588740|NCT03315286|2920485|Superiority|||||||0.6|||||||t-test, 2 sided|||Baseline results are reported here.|
1588741|NCT03315286|2920486|Superiority|||||||0.03|||||||t-test, 2 sided||||
1588742|NCT03315286|2920487|Superiority|||||||0.8|||||||t-test, 2 sided||||
1588743|NCT03312543|2920549|Equivalence|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.11|Standard Error of the Mean|0.094||0.224|2-Sided|95.0|-0.07|0.3|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.|||
1588744|NCT03312543|2920549|Superiority|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.47|Standard Deviation|0.578|<|0.001|2-Sided|95.0|0.32|0.63|||t-test, 2 sided||||
1588745|NCT03312543|2920549|Superiority|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.36|Standard Deviation|0.465|<|0.001|2-Sided|95.0|0.23|0.48|||t-test, 2 sided||||
1588746|NCT03312543|2920550|Equivalence|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.24|Standard Error of the Mean|0.092||0.009|2-Sided|95.0|0.06|0.42|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.|||
1588747|NCT03312543|2920550|Superiority|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.21|Standard Deviation|0.5||0.002|2-Sided|95.0|0.08|0.34|||t-test, 2 sided||||
1588748|NCT03312543|2920550|Superiority|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|-0.03|Standard Deviation|0.532||0.627|2-Sided|95.0|-0.17|0.1|||t-test, 2 sided||||
1588749|NCT03312543|2920551|Equivalence|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.04|Standard Error of the Mean|0.062||0.54|2-Sided|95.0|-0.09|0.16|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.|||
1588750|NCT03312543|2920551|Superiority|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.22|Standard Deviation|0.328|<|0.001|2-Sided|95.0|0.13|0.31|||t-test, 2 sided||||
1588751|NCT03312543|2920551|Superiority|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.2|Standard Deviation|0.349|<|0.001|2-Sided|95.0|0.11|0.29|||t-test, 2 sided||||
1588752|NCT03312543|2920552|Other|The null hypothesis was that the change from baseline to Week 12 was equal for the active cell and the sham cell. The alternative hypothesis was that the mean change from Baseline was not equal between the two cells.|Mean Difference (Net)|0.14|Standard Error of the Mean|0.06||0.025|2-Sided|95.0|0.02|0.25|||ANCOVA|With treatment and skin type group as factors and the corresponding averaged baseline score as a covariate.|||
1588753|NCT03312543|2920552|Superiority|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.3|Standard Deviation|0.341|<|0.001|2-Sided|95.0|0.21|0.39|||t-test, 2 sided||||
1588754|NCT03312543|2920552|Superiority|Superiority to baseline concluded if the lower bound of the 95% confidence interval for the mean difference is above 0.5.|Mean Difference (Net)|0.18|Standard Deviation|0.328|<|0.001|2-Sided|95.0|0.09|0.26|||t-test, 2 sided||||
1588755|NCT03311841|2920567|Other||Geometric least squares mean ratio|1.75|||||2-Sided|95.0|0.95|3.24|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588756|NCT03311841|2920567|Other||Geometric least squares mean ratio|3.1|||||2-Sided|95.0|1.64|5.86|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588757|NCT03311841|2920567|Other||Geometric least squares mean ratio|1.85|||||2-Sided|95.0|0.95|3.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588758|NCT03311841|2920567|Other||Geometric least squares mean ratio|1.06|||||2-Sided|95.0|0.63|1.78|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1588759|NCT03311841|2920567|Other||Geometric least squares mean ratio|1.44|||||2-Sided|95.0|0.84|2.47|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1588760|NCT03311841|2920567|Other||Geometric least squares mean ratio|1.49|||||2-Sided|95.0|0.81|2.73|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atovastatin|
1588761|NCT03311841|2920567|Other||Geometric least squares mean ratio|1.57|||||2-Sided|95.0|0.84|2.94|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atovastatin|
1588762|NCT03311841|2920567|Other||Geometric least squares mean ratio|0.6|||||2-Sided|95.0|0.3|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588763|NCT03311841|2920567|Other||Geometric least squares mean ratio|1.07|||||2-Sided|95.0|0.56|2.05|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588764|NCT03311841|2920567|Other||Geometric least squares mean ratio|1.51|||||2-Sided|95.0|0.77|2.97|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588765|NCT03311841|2920567|Other||Geometric least squares mean ratio|1.03|||||2-Sided|95.0|0.52|2.03|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588766|NCT03311841|2920567|Other||Geometric least squares mean ratio|0.98|||||2-Sided|95.0|0.58|1.66|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588767|NCT03311841|2920567|Other||Geometric least squares mean ratio|1.98|||||2-Sided|95.0|1.15|3.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588768|NCT03311841|2920567|Other||Geometric least squares mean ratio|1.3|||||2-Sided|95.0|0.75|2.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588769|NCT03311841|2920567|Other||Geometric least squares mean ratio|1.68|||||2-Sided|95.0|0.78|3.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588770|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.04|||||2-Sided|95.0|0.45|2.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588967|NCT03302559|2920883|Other|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Forehead)|
1599046|NCT02858401|2938155|Other|||||||1|||||||Fisher Exact||||
1588771|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.13|||||2-Sided|95.0|0.51|2.53|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588772|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.87|||||2-Sided|95.0|0.81|4.32|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588773|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.1|||||2-Sided|95.0|0.46|2.64|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588774|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.12|||||2-Sided|95.0|0.64|1.96|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1588775|NCT03311841|2920568|Other||Geometric least squares mean ratio|0.94|||||2-Sided|95.0|0.55|1.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1588776|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.24|||||2-Sided|95.0|0.71|2.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1588777|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.11|||||2-Sided|95.0|0.59|2.07|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1588778|NCT03311841|2920568|Other||Geometric least squares mean ratio|2.94|||||2-Sided|95.0|1.28|6.77|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin|
1588779|NCT03311841|2920568|Other||Geometric least squares mean ratio|2.16|||||2-Sided|95.0|0.97|4.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin|
1588780|NCT03311841|2920568|Other||Geometric least squares mean ratio|2.54|||||2-Sided|95.0|1.11|5.85|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin|
1588781|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.48|||||2-Sided|95.0|0.58|3.75|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin|
1588782|NCT03311841|2920568|Other||Geometric least squares mean ratio|0.89|||||2-Sided|95.0|0.61|1.31|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588783|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.08|||||2-Sided|95.0|0.75|1.57|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588784|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.2|||||2-Sided|95.0|0.82|1.76|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588785|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.19|||||2-Sided|95.0|0.81|1.75|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588786|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.47|||||2-Sided|95.0|0.91|2.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588787|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.33|||||2-Sided|95.0|0.84|2.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588788|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.84|||||2-Sided|95.0|1.14|2.98|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588789|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.49|||||2-Sided|95.0|0.92|2.4|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588790|NCT03311841|2920568|Other||Geometric least squares mean ratio|0.72|||||2-Sided|95.0|0.38|1.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1599047|NCT02858401|2938155|Other|||||||1|||||||Fisher Exact||||
1588791|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.75|||||2-Sided|95.0|0.93|3.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588792|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.71|||||2-Sided|95.0|0.89|3.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588793|NCT03311841|2920568|Other||Geometric least squares mean ratio|0.84|||||2-Sided|95.0|0.44|1.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588794|NCT03311841|2920568|Other||Geometric least squares mean ratio|0.55|||||2-Sided|95.0|0.36|0.83|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588795|NCT03311841|2920568|Other||Geometric least squares mean ratio|0.94|||||2-Sided|95.0|0.62|1.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588796|NCT03311841|2920568|Other||Geometric least squares mean ratio|1.06|||||2-Sided|95.0|0.69|1.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588797|NCT03311841|2920568|Other||Geometric least squares mean ratio|0.97|||||2-Sided|95.0|0.63|1.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588798|NCT03311841|2920569|Other||Geometric least squares mean ratio|0.95|||||2-Sided|95.0|0.43|2.08|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588799|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.49|||||2-Sided|95.0|0.7|3.18|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588800|NCT03311841|2920569|Other||Geometric least squares mean ratio|2.65|||||2-Sided|95.0|1.21|5.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588801|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.27|||||2-Sided|95.0|0.56|2.91|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588802|NCT03311841|2920569|Other||Geometric least squares mean ratio|0.83|||||2-Sided|95.0|0.44|1.57|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1588803|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.16|||||2-Sided|95.0|0.63|2.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1588804|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.68|||||2-Sided|95.0|0.89|3.19|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1588805|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.46|||||2-Sided|95.0|0.71|2.97|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1588806|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.17|||||2-Sided|95.0|0.58|2.35|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin|
1588807|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.65|||||2-Sided|95.0|0.84|3.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin|
1588808|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.8|||||2-Sided|95.0|0.9|3.62|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin|
1588809|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.16|||||2-Sided|95.0|0.53|2.52|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin|
1588810|NCT03311841|2920569|Other||Geometric least squares mean ratio|0.73|||||2-Sided|95.0|0.45|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1589093|NCT03286218|2921190|Other||LS Mean Difference|33.1|||||2-Sided|90.0|28.5|37.7||||||Overall Drug Liking|
1588811|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.08|||||2-Sided|95.0|0.68|1.71|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588812|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.39|||||2-Sided|95.0|0.87|2.24|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588813|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.03|||||2-Sided|95.0|0.64|1.65|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588814|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.34|||||2-Sided|95.0|0.76|2.36|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588815|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.25|||||2-Sided|95.0|0.72|2.15|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588816|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.97|||||2-Sided|95.0|1.12|3.46|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588817|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.33|||||2-Sided|95.0|0.76|2.34|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588818|NCT03311841|2920569|Other||Geometric least squares mean ratio|2.65|||||2-Sided|95.0|1.39|5.07|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588819|NCT03311841|2920569|Other||Geometric least squares mean ratio|5.28|||||2-Sided|95.0|2.83|9.87|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588820|NCT03311841|2920569|Other||Geometric least squares mean ratio|3.0|||||2-Sided|95.0|1.57|5.74|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588821|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.02|||||2-Sided|95.0|0.53|1.95|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588822|NCT03311841|2920569|Other||Geometric least squares mean ratio|0.4|||||2-Sided|95.0|0.23|0.69|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588823|NCT03311841|2920569|Other||Geometric least squares mean ratio|0.94|||||2-Sided|95.0|0.55|1.61|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588824|NCT03311841|2920569|Other||Geometric least squares mean ratio|1.3|||||2-Sided|95.0|0.75|2.28|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588825|NCT03311841|2920569|Other||Geometric least squares mean ratio|0.63|||||2-Sided|95.0|0.36|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588826|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.06|||||2-Sided|95.0|0.51|2.19|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588827|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.46|||||2-Sided|95.0|0.72|2.93|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588828|NCT03311841|2920570|Other||Geometric least squares mean ratio|2.25|||||2-Sided|95.0|1.09|4.63|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588829|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.25|||||2-Sided|95.0|0.58|2.67|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of rosuvastatin|
1588830|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.06|||||2-Sided|95.0|0.62|1.82|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1589342|NCT03259087|2922180|Other||Geometric Least Squares Mean Ratio (GMR)|0.64|||||2-Sided|90.0|0.47|0.88|||||GMR is ratio of Experimental Group / Healthy Group||
1588831|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.03|||||2-Sided|95.0|0.62|1.74|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1588832|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.33|||||2-Sided|95.0|0.78|2.28|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1588833|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.28|||||2-Sided|95.0|0.7|2.34|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of ortho-hydroxyatorvastatin|
1588834|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.45|||||2-Sided|95.0|0.78|2.71|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin|
1588835|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.52|||||2-Sided|95.0|0.83|2.77|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin|
1588836|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.66|||||2-Sided|95.0|0.89|3.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin|
1588837|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.11|||||2-Sided|95.0|0.55|2.23|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin|
1588838|NCT03311841|2920570|Other||Geometric least squares mean ratio|0.85|||||2-Sided|95.0|0.56|1.29|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588839|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.09|||||2-Sided|95.0|0.73|1.63|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588840|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.27|||||2-Sided|95.0|0.83|1.92|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588841|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.03|||||2-Sided|95.0|0.68|1.56|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588842|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.43|||||2-Sided|95.0|0.85|2.4|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588843|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.26|||||2-Sided|95.0|0.77|2.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588844|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.84|||||2-Sided|95.0|1.09|3.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588845|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.31|||||2-Sided|95.0|0.78|2.2|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588846|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.46|||||2-Sided|95.0|0.8|2.64|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588847|NCT03311841|2920570|Other||Geometric least squares mean ratio|3.09|||||2-Sided|95.0|1.75|5.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588848|NCT03311841|2920570|Other||Geometric least squares mean ratio|2.38|||||2-Sided|95.0|1.32|4.32|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588849|NCT03311841|2920570|Other||Geometric least squares mean ratio|0.96|||||2-Sided|95.0|0.53|1.73|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588850|NCT03311841|2920570|Other||Geometric least squares mean ratio|0.42|||||2-Sided|95.0|0.25|0.7|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1589394|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2752|||<|0.001|2-Sided|95.0|0.1808|0.3696|||ANOVA|||1 hour|
1588851|NCT03311841|2920570|Other||Geometric least squares mean ratio|0.93|||||2-Sided|95.0|0.57|1.52|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588852|NCT03311841|2920570|Other||Geometric least squares mean ratio|1.26|||||2-Sided|95.0|0.76|2.09|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588853|NCT03311841|2920570|Other||Geometric least squares mean ratio|0.67|||||2-Sided|95.0|0.4|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588854|NCT03311841|2920572|Other|Comparison of rosuvastatin|Geometric least squares mean ratio|0.71|||||2-Sided|95.0|0.27|1.86|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588855|NCT03311841|2920572|Other|Comparison of rosuvastatin|Geometric least squares mean ratio|1.25|||||2-Sided|95.0|0.49|3.16|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588856|NCT03311841|2920572|Other|Comparison of rosuvastatin|Geometric least squares mean ratio|1.97|||||2-Sided|95.0|0.75|5.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588857|NCT03311841|2920572|Other|Comparison of rosuvastatin|Geometric least squares mean ratio|0.9|||||2-Sided|95.0|0.33|2.45|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588858|NCT03311841|2920572|Other|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|0.79|||||2-Sided|95.0|0.46|1.33|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588859|NCT03311841|2920572|Other|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.09|||||2-Sided|95.0|0.65|1.81|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588860|NCT03311841|2920572|Other|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.31|||||2-Sided|95.0|0.75|2.29|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588861|NCT03311841|2920572|Other|Comparison of ortho-hydroxyatorvastatin|Geometric least squares mean ratio|1.38|||||2-Sided|95.0|0.76|2.49|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588862|NCT03311841|2920572|Other|Comparison of atorvastatin|Geometric least squares mean ratio|1.13|||||2-Sided|95.0|0.57|2.22|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588863|NCT03311841|2920572|Other||Geometric least squares mean ratio|1.63|||||2-Sided|95.0|0.85|3.14|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of atorvastatin|
1588864|NCT03311841|2920572|Other|Comparison of atorvastatin|Geometric least squares mean ratio|1.75|||||2-Sided|95.0|0.89|3.46|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588865|NCT03311841|2920572|Other|Comparison of atorvastatin|Geometric least squares mean ratio|1.13|||||2-Sided|95.0|0.53|2.41|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588866|NCT03311841|2920572|Other|Comparison of pitavastatin lactone|Geometric least squares mean ratio|0.71|||||2-Sided|95.0|0.43|1.17|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588867|NCT03311841|2920572|Other|Comparison of pitavastatin lactone|Geometric least squares mean ratio|1.09|||||2-Sided|95.0|0.68|1.76|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588868|NCT03311841|2920572|Other||Geometric least squares mean ratio|1.45|||||2-Sided|95.0|0.88|2.38|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588869|NCT03311841|2920572|Other||Geometric least squares mean ratio|1.05|||||2-Sided|95.0|0.64|1.72|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin lactone|
1588870|NCT03311841|2920572|Other||Geometric least squares mean ratio|1.3|||||2-Sided|95.0|0.74|2.27|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1590714|NCT03191552|2924338|Superiority|||||||0.14|||||||Kruskal-Wallis||||
1588871|NCT03311841|2920572|Other||Geometric least squares mean ratio|1.25|||||2-Sided|95.0|0.73|2.13|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588872|NCT03311841|2920572|Other||Geometric least squares mean ratio|1.96|||||2-Sided|95.0|1.12|3.42|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of pitavastatin|
1588873|NCT03311841|2920572|Other|Comparison of pitavastatin|Geometric least squares mean ratio|1.32|||||2-Sided|95.0|0.76|2.31|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.||
1588874|NCT03311841|2920572|Other||Geometric least squares mean ratio|3.39|||||2-Sided|95.0|1.78|6.44|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588875|NCT03311841|2920572|Other||Geometric least squares mean ratio|4.98|||||2-Sided|95.0|2.62|9.48|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588876|NCT03311841|2920572|Other||Geometric least squares mean ratio|2.87|||||2-Sided|95.0|1.51|5.47|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588877|NCT03311841|2920572|Other||Geometric least squares mean ratio|1.01|||||2-Sided|95.0|0.53|1.93|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of dabigatran|
1588878|NCT03311841|2920572|Other||Geometric least squares mean ratio|0.4|||||2-Sided|95.0|0.23|0.7|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588879|NCT03311841|2920572|Other|Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Geometric least squares mean ratio|0.95|||||2-Sided|95.0|0.56|1.62||||||Comparison of midazolam|
1588880|NCT03311841|2920572|Other|Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Geometric least squares mean ratio|1.33|||||2-Sided|95.0|0.77|2.31||||||Comparison of midazolam|
1588881|NCT03311841|2920572|Other||Geometric least squares mean ratio|0.64|||||2-Sided|95.0|0.37|1.11|||||Geometric least squares mean ratio and 95% confidence interval could not be determined for comparisons where one or both of the geometric least squares means was not calculable because some individual values were treated as 0.|Comparison of midazolam|
1588882|NCT03311646|2920585|Other|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|0.2||||0.84|2-Sided|95.0|-2.0|2.5||alpha=0.05|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.|Interaction p=0.94
1588883|NCT03311646|2920586|Other|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|3.19|||<|0.001|2-Sided|95.0|1.77|4.6|||Mixed Models Analysis||Mean Difference=VLNC-NNC|Comparison of Minnesota Nicotine Withdrawal Scale during VLNC condition to Minnesota Nicotine Withdrawal Scale during the NNC (baseline) condition.|Interaction p=0.95
1588884|NCT03311646|2920587|Other|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|1.13||||0.15|2-Sided|95.0|-0.41|2.66||alpha=0.05|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of cigarette per day during VLNC condition to cigarette per day during the NNC (baseline) condition.|Interaction p=0.23
1588885|NCT03311646|2920588|Other|A linear mixed-model was used. The model included terms for cigarette nicotine content (VLNC/NNC), time, cohort, a random effect for subject, and a nicotine content x time interaction. Interaction was dropped when nonsignificant. Reported below is the effect of nicotine content as well as the interaction p-value.|Mean Difference (Final Values)|0.07||||0.92|2-Sided|95.0|-1.27|1.4||alpha=0.05.|Mixed Models Analysis||Mean Difference = VLNC-NNC|Comparison of carbon monoxide during VLNC condition to carbon monoxide during the NNC (baseline) condition.|Interaction p-value: p=0.27
1588886|NCT03310268|2920602|Other||Difference of Least Square mean|-3.16|Standard Error of the Mean|4.648||0.4979|2-Sided|95.0|-12.33|6.017|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1588887|NCT03310268|2920602|Other||Difference of Least Square mean|-4.04|Standard Error of the Mean|4.588||0.3793|2-Sided|95.0|-13.099|5.011|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1589094|NCT03286218|2921193|Non-Inferiority|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 400 mg dose is 5 mm.|LS Mean Difference|8.79|||||2-Sided|90.0|4.8|12.8|||||||
1588888|NCT03310268|2920602|Other||Difference of Least Square mean|-7.2|Standard Error of the Mean|4.649||0.1232|2-Sided|95.0|-16.376|1.975|||ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1588889|NCT03310268|2920603|Other||Difference of Least Square mean|0.21|Standard Error of the Mean|0.094||0.0298|2-Sided|95.0|0.02|0.393|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1588890|NCT03310268|2920603|Other||Difference of Least Square mean|-0.02|Standard Error of the Mean|0.093||0.8411|2-Sided|95.0|-0.202|0.164|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1588891|NCT03310268|2920603|Other||Difference of Least Square mean|0.19|Standard Error of the Mean|0.094||0.0476|2-Sided|95.0|0.002|0.374|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1588892|NCT03309202|2920618|Other||Mean Difference (Final Values)|266.29|||||2-Sided|90.0|163.08|434.8|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588893|NCT03309202|2920618|Other||Mean Difference (Final Values)|182.51|||||2-Sided|90.0|111.78|298.02|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588894|NCT03309202|2920618|Other||Mean Difference (Final Values)|169.84|||||2-Sided|90.0|104.02|277.32|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588895|NCT03309202|2920619|Other||Mean Difference (Final Values)|293.31|||||2-Sided|90.0|186.04|462.44|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588896|NCT03309202|2920619|Other||Mean Difference (Final Values)|172.74|||||2-Sided|90.0|109.56|272.35|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588897|NCT03309202|2920619|Other||Mean Difference (Final Values)|162.58|||||2-Sided|90.0|103.12|256.32|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588898|NCT03309202|2920620|Other||Mean Difference (Final Values)|224.7373|||||2-Sided|90.0|148.6962|339.6647|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588899|NCT03309202|2920620|Other||Mean Difference (Final Values)|147.0778|||||2-Sided|90.0|97.3132|222.2911|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588900|NCT03309202|2920620|Other||Mean Difference (Final Values)|124.7309|||||2-Sided|90.0|82.5275|188.5165|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588901|NCT03309202|2920621|Other||Mean Difference (Final Values)|118.65|||||2-Sided|90.0|82.33|170.99|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588902|NCT03309202|2920621|Other||Mean Difference (Final Values)|124.23|||||2-Sided|90.0|86.2|179.03|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588903|NCT03309202|2920621|Other||Mean Difference (Final Values)|136.37|||||2-Sided|90.0|94.63|196.53|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588904|NCT03309202|2920622|Other||Mean Difference (Final Values)|130.55|||||2-Sided|90.0|101.63|167.7|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 4 (Severe Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588905|NCT03309202|2920622|Other||Mean Difference (Final Values)|117.49|||||2-Sided|90.0|91.46|150.93|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 3 (Moderate Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588906|NCT03309202|2920622|Other||Mean Difference (Final Values)|130.47|||||2-Sided|90.0|101.57|167.6|||||Estimate mean difference was derived from ratio (%) of adjusted geometric means of Test and Reference.Cohort 2 (Mild Hepatic Impairment) was Test and Cohort 1 (Without Hepatic Impairment) was Reference.||
1588907|NCT03308968|2920645|Other||LS mean difference|-3.5|Standard Error of the Mean|0.36|<|0.0001|2-Sided|95.0|-4.19|-2.78|||ANCOVA|||Analysis was performed using ANCOVA method with treatment, sex, region, special group of treatment failure (yes or no), migraine classification (that is; CM or EM), and treatment-by-migraine classification interaction as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates. The stratification factors (as randomized) were used in the model.|
1588908|NCT03308968|2920645|Other||Least square (LS) mean difference|-3.1|Standard Error of the Mean|0.36|<|0.0001|2-Sided|95.0|-3.84|-2.42|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) method with treatment, sex, region, special group of treatment failure (yes or no), migraine classification (that is; CM or EM), and treatment-by-migraine classification interaction as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates. The stratification factors (as randomized) were used in the model.|
1591002|NCT03161938|2925187|Superiority|||||||0.491|||||||Chi-squared, Corrected|||Day 4, sadness|
1588909|NCT03307252|2920665|Other||Adjusted gMean Ratio|215.28|Standard Error of the Mean|13.1|||2-Sided|90.0|197.53|234.63|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588910|NCT03307252|2920665|Other||Adjusted gMean Ratio|101.21|Standard Error of the Mean|9.4|||2-Sided|90.0|95.15|107.66|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588911|NCT03307252|2920665|Other||Adjusted gMean ratio|260.11|Standard Error of the Mean|14.7|||2-Sided|90.0|237.96|284.32|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588912|NCT03307252|2920666|Other||Adjusted gMean Ratio|106.55|Standard Error of the Mean|12.8|||2-Sided|90.0|96.87|117.19|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588913|NCT03307252|2920666|Other||Adjusted gMean Ratio|131.37|Standard Error of the Mean|13.4|||2-Sided|90.0|120.37|143.37|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588914|NCT03307252|2920666|Other||Adjusted gMean ratio|100.78|Standard Error of the Mean|10.0|||2-Sided|90.0|93.59|108.51|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588915|NCT03307252|2920667|Other||Adjusted gMean Ratio|340.67|Standard Error of the Mean|23.9|||2-Sided|90.0|288.63|402.1|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588916|NCT03307252|2920667|Other||Adjusted gMean Ratio|108.56|Standard Error of the Mean|10.0|||2-Sided|90.0|101.22|116.43|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588917|NCT03307252|2920667|Other||Adjusted gMean Ratio|112.73|Standard Error of the Mean|11.2|||2-Sided|90.0|104.23|121.92|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588918|NCT03307252|2920668|Other||Adjusted gMean Ratio|124.06|Standard Error of the Mean|23.9|||2-Sided|90.0|105.11|146.43|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588919|NCT03307252|2920668|Other||Adjusted gMean Ratio|83.99|Standard Error of the Mean|10.0|||2-Sided|90.0|78.32|90.08|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588920|NCT03307252|2920668|Other||Adjusted gMean ratio|92.24|Standard Error of the Mean|11.2|||2-Sided|90.0|85.28|99.76|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588968|NCT03302559|2920884|Other|Testing hypothesis is that the mean change from baseline is zero||||||0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Perioral)|
1588969|NCT03302559|2920884|Other|Testing hypothesis is that the mean change from baseline is zero.||||||0.0006||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Cheeks)|
1588921|NCT03307252|2920669|Other||Adjusted gMean Ratio|428.23|Standard Error of the Mean|26.8|||2-Sided|90.0|359.78|509.7|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588922|NCT03307252|2920669|Other||Adjusted gMean Ratio|101.35|Standard Error of the Mean|12.0|||2-Sided|90.0|93.65|109.7|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588923|NCT03307252|2920669|Other||Adjusted gMean ratio|122.94|Standard Error of the Mean|18.0|||2-Sided|90.0|110.25|137.09|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588924|NCT03307252|2920669|Other||Adjusted geometric mean (gMean) ratio|87.07|Standard Error of the Mean|20.9|||2-Sided|90.0|76.08|99.64|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588925|NCT03307252|2920670|Other||Adjusted gMean Ratio|116.88|Standard Error of the Mean|14.4|||2-Sided|90.0|105.07|130.03|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588926|NCT03307252|2920670|Other||Adjusted gMean Ratio|122.65|Standard Error of the Mean|20.1|||2-Sided|90.0|107.68|139.69|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588927|NCT03307252|2920670|Other||Adjusted gMean ratio|104.78|Standard Error of the Mean|21.0|||2-Sided|90.0|89.97|122.03|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588928|NCT03307252|2920670|Other||Adjusted geometric mean (gMean) ratio|218.26|Standard Error of the Mean|27.7|||2-Sided|90.0|180.19|264.36|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588929|NCT03307252|2920671|Other||Adjusted gMean Ratio|1125.1|Standard Error of the Mean|30.1|||2-Sided|90.0|914.63|1384.0|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588930|NCT03307252|2920671|Other||Adjusted gMean Ratio|112.31|Standard Error of the Mean|13.4|||2-Sided|90.0|102.26|123.35|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588931|NCT03307252|2920671|Other||Adjusted gMean ratio|135.07|Standard Error of the Mean|19.6|||2-Sided|90.0|117.83|154.84|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588932|NCT03307252|2920671|Other||Adjusted geometric mean (gMean) ratio|218.26|Standard Error of the Mean|27.7|||2-Sided|90.0|180.19|264.36|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588970|NCT03302559|2920884|Other|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Periocular)|
1589343|NCT03259087|2922180|Other||Geometric Least Squares Mean Ratio (GMR)|0.9|||||2-Sided|90.0|0.74|1.11|||||GMR is ratio of Experimental Group / Healthy Group||
1588933|NCT03307252|2920672|Other||Adjusted gMean Ratio|115.39|Standard Error of the Mean|30.1|||2-Sided|90.0|93.8|141.94|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588934|NCT03307252|2920672|Other||Adjusted gMean Ratio|80.19|Standard Error of the Mean|13.4|||2-Sided|90.0|73.01|88.08|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588935|NCT03307252|2920672|Other||Adjusted gMean ratio|95.18|Standard Error of the Mean|19.6|||2-Sided|90.0|83.03|109.11|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588936|NCT03307252|2920672|Other||Adjusted geometric mean (gMean) ratio|121.64|Standard Error of the Mean|27.7|||2-Sided|90.0|100.43|147.33|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588937|NCT03307252|2920673|Other||Adjusted gMean Ratio|223.24|Standard Error of the Mean|13.9|||2-Sided|90.0|203.79|244.55|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588938|NCT03307252|2920673|Other||Adjusted gMean Ratio|100.8|Standard Error of the Mean|9.6|||2-Sided|90.0|94.62|107.39|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588939|NCT03307252|2920673|Other||Adjusted gMean ratio|271.63|Standard Error of the Mean|15.9|||2-Sided|90.0|246.74|299.03|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588940|NCT03307252|2920673|Other||Adjusted geometric mean (gMean) ratio|106.78|Standard Error of the Mean|15.5|||2-Sided|90.0|96.51|118.15|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T4 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588941|NCT03307252|2920674|Other||Adjusted gMean Ratio|107.42|Standard Error of the Mean|12.9|||2-Sided|90.0|97.57|118.27|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588942|NCT03307252|2920674|Other||Adjusted gMean Ratio|130.94|Standard Error of the Mean|13.6|||2-Sided|90.0|119.82|143.1|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588943|NCT03307252|2920674|Other||Adjusted gMean ratio|101.21|Standard Error of the Mean|9.2|||2-Sided|90.0|94.59|108.3|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588944|NCT03307252|2920674|Other||Adjusted geometric mean (gMean) ratio|125.61|Standard Error of the Mean|13.2|||2-Sided|90.0|113.99|138.43|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T3 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588971|NCT03302559|2920884|Other|Testing hypothesis is that the mean change from baseline is zero.||||||0.005||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Forehead)|
1589095|NCT03286218|2921193|Non-Inferiority|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 200 mg dose is 5 mm.|LS Mean Difference|12.1|||||2-Sided|90.0|8.1|16.1|||||||
1588945|NCT03307252|2920675|Other||Adjusted gMean Ratio|348.06|Standard Error of the Mean|21.5|||2-Sided|90.0|299.64|404.31|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588946|NCT03307252|2920675|Other||Adjusted gMean Ratio|108.55|Standard Error of the Mean|10.7|||2-Sided|90.0|100.68|117.03|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588947|NCT03307252|2920675|Other||Adjusted gMean ratio|119.78|Standard Error of the Mean|12.1|||2-Sided|90.0|110.03|130.39|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588948|NCT03307252|2920675|Other||Adjusted geometric mean (gMean) ratio|131.41|Standard Error of the Mean|17.9|||2-Sided|90.0|115.93|148.97|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T2 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588949|NCT03307252|2920676|Other||Adjusted gMean Ratio|113.4|Standard Error of the Mean|21.5|||2-Sided|90.0|97.62|131.72|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Rosuvastatin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588950|NCT03307252|2920676|Other||Adjusted gMean Ratio|82.97|Standard Error of the Mean|10.7|||2-Sided|90.0|76.96|89.46|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Metformin, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588951|NCT03307252|2920676|Other||Adjusted gMean ratio|93.76|Standard Error of the Mean|12.1|||2-Sided|90.0|86.12|102.06|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Furosemide, ANOVA model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588952|NCT03307252|2920676|Other||Adjusted geometric mean (gMean) ratio|100.7|Standard Error of the Mean|17.9|||2-Sided|90.0|88.84|114.15|||||Standard Error of the mean is actually intra individual geometric coefficient of variation (gCV). Adjusted gMean ratio is given for T1 vs. R1.||Digoxin, Analysis of variance (ANOVA) model on the logarithmic scale includes effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.
1588953|NCT03307174|2920683|Superiority|||||||0.74|||||||Wilcoxon (Mann-Whitney)||||
1588954|NCT03304873|2920818|Superiority|||||||0.99|||||||t-test, 1 sided||||
1588955|NCT03304873|2920819|Superiority|||||||0.0004|||||||t-test, 1 sided||||
1588956|NCT03303521|2920858|Superiority||Odds Ratio (OR)|35.51|||<|0.001|2-Sided|95.0|8.53|309.48|||Fisher Exact||||
1588957|NCT03303521|2920860|Superiority||Odds Ratio (OR)|68.77|||<|0.001|2-Sided|95.0|10.85|2810.85|||Fisher Exact||||
1588958|NCT03302975|2920868|Superiority|||||||0.001|||||||ANOVA||||
1588959|NCT03302559|2920875|Other|Testing hypothesis is that the mean change from baseline is zero.||||||0.4||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Target Lesion)|
1588960|NCT03302559|2920875|Other|Testing hypothesis is that the mean change from baseline is zero.||||||0.3||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Normal Skin)|
1588961|NCT03302559|2920880|Other|Testing hypothesis is that the mean change from baseline is zero.||||||0.02||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12|
1588962|NCT03302559|2920881|Other|Testing hypothesis is that the mean change from baseline is zero.||||||0.0008||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12|
1588963|NCT03302559|2920882|Other|Testing hypothesis is that the mean change from baseline is zero.||||||0.002||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12|
1588964|NCT03302559|2920883|Other|Testing hypothesis is that the mean change from baseline is zero.||||||0.5||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Perioral)|
1588965|NCT03302559|2920883|Other|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Cheeks)|
1588966|NCT03302559|2920883|Other|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.006||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12 (Periocular)|
1589344|NCT03259087|2922184|Other||Geometric Least Squares Mean Ratio (GMR)|0.63|||||2-Sided|95.0|0.52|0.77|||||GMR is ratio of Experimental Group / Healthy Group||
1588972|NCT03302559|2920885|Other|Testing hypothesis is that the mean change from baseline is zero.|||||<|0.001||||||Statistical significance is defined as a p-value ≤0.05.|Paired t-test|||Change from Baseline at Week 12|
1588973|NCT03301844|2920887|Other|||||||0.7353|||||||Chi-squared||||"The incidence of all the treatment-emergent systemic Adverse Events recorded in the eCRF was presented overall at patient level; the incidence of all the treatment-emergent ocular Adverse Events recorded in eCRF was presented by treatment group at eye level.~Incidence of treatment-emergent ocular Adverse Events was compared between treatment groups by means of a Chi-square test."
1588974|NCT03301844|2920888|Superiority|||||||0.071|||||||Chi-squared||||"Patient preference for one of the two treatments at Visit 3 was presented overall in terms of number and percentage of patients preferring the standard or the study treatment.~Patient preference was compared between the standard and the study treatment with a Chi-Square test for equal proportion."
1588975|NCT03301740|2920894|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.6||||0.5|2-Sided|95.0|0.2|2.4||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important tingling/feeling of pins and needles between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588976|NCT03301740|2920895|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.2||||0.7|2-Sided|95.0|0.5|2.6||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important restless legs/difficulty keeping legs still between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588977|NCT03301740|2920896|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|2.8||||0.02|2-Sided|95.0|1.2|6.6||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important itching between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588978|NCT03301740|2920897|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.9||||0.8|2-Sided|95.0|0.4|2.3||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important headache between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588979|NCT03301740|2920898|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.6||||0.2|2-Sided|95.0|0.3|1.2||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important thirst/dry mouth between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588980|NCT03301740|2920899|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.3||||0.7|2-Sided|95.0|0.3|6.5||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important shortness of breath between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588981|NCT03301740|2920900|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||1|2-Sided|95.0|0.2|6.0||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important chest pain between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588982|NCT03301740|2920901|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|3.1||||0.3|2-Sided|95.0|0.3|32.4||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important racing heart/heart palpitations between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588994|NCT03301649|2920915|Superiority||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).|
1589345|NCT03259087|2922184|Other||Geometric Least Squares Mean Ratio (GMR)|0.25|||||2-Sided|90.0|0.21|0.31|||||GMR is ratio of Experimental Group / Healthy Group||
1588983|NCT03301740|2920902|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.2||||0.04|2-Sided|95.0|0.1|0.9||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important dizziness/lightheadedness between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588984|NCT03301740|2920903|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||1|2-Sided|95.0|0.1|16.0|||Mixed Models Analysis|||Null hypothesis = no difference in clinically important Vomiting/throwing up score between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588985|NCT03301740|2920904|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.7||||0.5|2-Sided|95.0|0.2|2.2||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important nausea/upset stomach between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588986|NCT03301740|2920905|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||0.9|2-Sided|95.0|0.4|2.1||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in clinically important cramping between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588987|NCT03301740|2920906|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.0||||0.8|2-Sided|95.0|0.7|1.3||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in failed target weight achievement between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588988|NCT03301740|2920907|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Beta coefficient|-0.2||||0.9|2-Sided|95.0|-2.0|1.7||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in nadir systolic BP between UF profiling and conventional HD. Repeated measure linear regression was performed, giving each subject a random intercept term. The coefficient is the difference in the outcome between UF profiling and conventional HD.|
1588989|NCT03301740|2920908|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Mean Difference (Final Values)|-0.8||||0.2|2-Sided|95.0|-2.0|0.5||Statistically significant p-value is <0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis = no difference in left ventricular GLS change between UF profiling and conventional HD. Wilcoxon (Mann-Whitney) tests were performed assessing the difference of the endpoint between the 2 treatment groups.|
1588990|NCT03301740|2920909|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|0.5||||0.1|2-Sided|95.0|0.2|1.3||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in troponin T rise between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588991|NCT03301740|2920910|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Beta coefficient|-2.8||||0.2|2-Sided|95.0|-6.9|1.4||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in troponin T change between UF profiling and conventional HD. Repeated measure linear regression was performed, giving each subject a random intercept term. The coefficient is the difference in the outcome between UF profiling and conventional HD.|
1588992|NCT03301740|2920911|Equivalence|The equivalence margin is the standard error of the estimated differences between UF and standard treatment from the repeated measure mixed model.|Odds Ratio (OR)|1.2||||0.5|2-Sided|95.0|0.8|1.7||Statistically significant p-value is <0.05|Mixed Models Analysis|||Null hypothesis = no difference in intradialytic hypotension between UF profiling and conventional HD. Likelihood ratio tests were performed using repeated measure logistic regression with the binary treatment indicator as a fixed effect predictor and assigning each subject a random intercept term. A likelihood ratio test assessed the significance of whether the coefficient corresponding to the binary treatment indicator equals to zero.|
1588993|NCT03301714|2920914|Equivalence|equivalence analysis|Mean Difference (Final Values)|7.62||||0|2-Sided|95.0||||baseline demographics, correlated errors due to repeated measures, and bias due to lost to follow-up were accounted for via Generalized Estimating Equation (statistical threshold <0.01)|Regression, Linear||Mean change difference in oral health related quality of life among control, intervention 1: group-based oral health education and intervention 2: individual-based oral health education using motivational interviewing.||
1599048|NCT02858401|2938156|Other|||||||1|||||||Fisher Exact||||
1588995|NCT03301649|2920915|Superiority||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).|
1588996|NCT03301649|2920916|Equivalence|Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).|Difference in percentage of participants|0.9|||||2-Sided|90.0|-2.6|4.5||||||If the 90% CI for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.|
1588997|NCT03301649|2920917|Superiority||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using LOCF method).|
1588998|NCT03301649|2920917|Superiority||||||<|0.0001||||||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran- Mantel-Haenszel test, stratified by clinical site in mITT population (using last observation carried forward [LOCF] method).|
1588999|NCT03301649|2920918|Equivalence|Therapeutic equivalence was demonstrated if 90% CI of percentage difference between generic ivermectin lotion and sklice (ivermectin) lotion group was within the range (-20%, +20%).|Difference in percentage of participants|1.9|||||2-Sided|90.0|-3.9|7.8||||||If the 90% confidence interval (CI) for the absolute difference between the percentage of participants who were considered a treatment success in the generic ivermectin lotion and sklice (ivermectin) lotion was contained within the range (-20%, +20%) then therapeutic equivalence of the generic ivermectin lotion and sklice (ivermectin) lotion was considered to have been demonstrated.|
1589000|NCT03301155|2920925|Superiority||||||>|0.999|||||||Fisher Exact||||
1589001|NCT03301155|2920926|Superiority||||||>|0.999|||||||Fisher Exact||||
1589002|NCT03301155|2920927|Superiority|||||||0.1372|||||||Fisher Exact||||
1589003|NCT03301155|2920928|Superiority|||||||0.0021|||||||Fisher Exact|||Comparison between groups on week 12|
1589004|NCT03301155|2920928|Superiority|Adjusted with Holm method for multiple comparrisons||||||0.0003|||||||Fisher Exact|||Comparison between groups on week 8|
1589005|NCT03301155|2920928|Superiority|||||||0.0003||||||Adjusted with Holm method for multiple comparrisons|Fisher Exact|||Comparison between groups on week 4|
1589006|NCT03301155|2920929|Superiority|superiority margin for hazard ratio was prespecified as 0.846. Lower hazard is better thus the upper confidence limit of HR expected to be lesser than margin|Hazard Ratio (HR)|0.645||||0.0218|2-Sided|95.0|0.496|0.839|||Regression, Cox||Lower HR is better||
1589007|NCT03301155|2920929|Superiority|||||||0.001|||||||Regression, Logistic|Comparison performed on the regression parameters scale. Estimates for mean time obtained under assumption of exponentially distributed time-to-event.|||
1589008|NCT03300570|2920938|Superiority|||||||0.15|||||||Wilcoxon (Mann-Whitney)||||
1589009|NCT03298867|2920965|Superiority||Difference in LS mean|9.36|Standard Error of the Mean|2.651|<|0.001|2-Sided|95.0|4.08|14.64||Results obtained from an MMRM with an unstructured covariance matrix including the following terms: Baseline value, tobacco use status, treatment group, visit, visit-by-treatment interaction and visit-by-Baseline-value interaction.|mixed-effect model repeated measure||||
1589010|NCT03298867|2920966|Superiority||Stratified difference|39.29|Standard Error of the Mean|12.11||0.001|2-Sided|95.0|15.55|63.02||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.||Test statistic=3.244, calculated by dividing the stratified difference by the SE.
1589011|NCT03298867|2920967|Superiority||Difference in LS mean|-2.28|Standard Error of the Mean|0.244|<|0.001|2-Sided|95.0|-2.77|-1.8||Results obtained from an MMRM with an unstructured covariance matrix including the following terms: Baseline value, tobacco use status, treatment group, visit, visit-by-treatment interaction and visit-by-Baseline-value interaction.|mixed model repeated-measures (MMRM)||||
1589012|NCT03298867|2920968|Superiority||Stratified difference|36.03|Standard Error of the Mean|9.51|<|0.001|2-Sided|95.0|17.39|54.67||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.||Test statistic=3.788, calculated by dividing the stratified difference by the SE.
1589013|NCT03298867|2920969|Superiority||Stratified difference|70.82|Standard Error of the Mean|7.62|<|0.001|2-Sided|95.0|55.89|85.75||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with CMH weights.||Test statistic=9.298, calculated by dividing the stratified difference by the SE.
1589014|NCT03298867|2920970|Superiority||Stratified difference|73.45|Standard Error of the Mean|7.43|<|0.001|2-Sided|95.0|58.89|88.01||Two-sided p-value calculated assuming the test statistic was distributed as a standard normal random variable.|Cochran-Mantel-Haenszel||Stratified difference (teprotumumab - placebo) is a weighted average of the difference within each stratum. Estimates from the 2 strata (tobacco user, tobacco non-user) were combined with Cochran-Mantel-Haenszel (CMH) weights.||Test statistic=9.889, calculated by dividing the stratified difference by the SE.
1589015|NCT03296072|2921018|Other||Difference of Least Square mean|0.97|||<|0.0001|2-Sided|95.0|0.75|1.2|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.||
1589016|NCT03296072|2921019|Other||Difference of Least Square mean|10.98|||<|0.0001|2-Sided|95.0|6.58|15.37|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.||
1589090|NCT03286218|2921190|Other||LS Mean Difference|24.3|||||2-Sided|90.0|19.7|28.9||||||Overall Drug Liking|
1589017|NCT03296072|2921020|Other||Difference of Least Square mean|7.57|||<|0.0001|2-Sided|95.0|5.07|11.07|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.||
1589018|NCT03296072|2921021|Other||Difference of Least Square mean|1.81|||<|0.0001|2-Sided|95.0|1.59|2.04|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.||
1589019|NCT03296072|2921022|Other||Difference of Least Square mean|33.29|||<|0.0001|2-Sided|95.0|28.89|37.68|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.||
1589020|NCT03296072|2921023|Other||Difference of Least Square mean|7.69|||<|0.0001|2-Sided|95.0|5.18|10.19|||ANOVA|From ANOVA with fixed factors for study period and treatment, and a random effect for participant.|Difference is first-named treatment minus second-named treatment such that a positive difference favors the first named treatment.||
1589021|NCT03295630|2921025|Other||Intraclass Correlation Coefficient|0.99|||||2-Sided|95.0|0.99|1.0||||||Correlation between accelerometer quantified steps (ankle placement) and observed steps|
1589022|NCT03295630|2921025|Other||Mean Difference (Final Values)|-0.84|||||2-Sided|||||||||Difference (steps) between accelerometer quantified steps (ankle placement) and observed step count|
1589023|NCT03295630|2921025|Other||Intraclass Correlation Coefficient|0.46|||||2-Sided|95.0|-0.1|0.78||||||Correlation between accelerometer quantified step count (thigh placement) and observed step count|
1589024|NCT03295630|2921025|Other||Mean Difference (Final Values)|-17.7|||||2-Sided|||||||||Difference (steps) between accelerometer quantified step count (thigh placement) and observed step count|
1589025|NCT03294538|2921074|Superiority|The proportion of participants considered as Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Treatment Success in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Treatment Success than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|3.9||||0.4949|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.|
1589026|NCT03294538|2921074|Superiority|The proportion of participants considered as Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Treatment Success in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Treatment Success than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|4.9||||0.2897|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the secondary endpoint was evaluated in the mITT population.|
1589027|NCT03294538|2921075|Equivalence|If the adjusted 90% confidence interval on the difference between proportions of participants considered Treatment Success in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group was contained within the equivalence range [-0.20, +0.20], then treatment with generic estradiol vaginal cream and treatment with Estrace Vaginal Cream were considered therapeutically equivalent.|Odds Ratio (OR)|-1.4|||||2-Sided|90.0|-9.0|6.2||||||Therapeutic equivalence of the generic estradiol vaginal cream group to the Estrace Vaginal Cream group based on the secondary endpoint was evaluated in the PP population.|
1589028|NCT03294538|2921076|Superiority|The proportion of participants considered as Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Responders in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Responders than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|20.2|||<|0.0001|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.|
1589029|NCT03294538|2921076|Superiority|The proportion of participants considered as Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group were each compared to the proportion of Responders in the vehicle vaginal cream group. If both the generic estradiol vaginal cream group and the Estrace Vaginal Cream group demonstrated a statistically significant greater proportion of Responders than the vehicle vaginal cream group, then superiority was concluded.|Odds Ratio (OR)|19.9|||<|0.0001|||||||Cochran-Mantel-Haenszel|||Superiority of the generic estradiol vaginal cream group and the Estrace Vaginal Cream group to the vehicle vaginal cream group based on the primary endpoint was evaluated in the mITT population.|
1589030|NCT03294538|2921077|Equivalence|If the adjusted 90% confidence interval on the difference between proportions of participants considered Responders in the generic estradiol vaginal cream group and the Estrace Vaginal Cream group was contained within the equivalence range [-0.20, +0.20], then treatment with generic estradiol vaginal cream and treatment with Estrace Vaginal Cream were considered therapeutically equivalent.|Odds Ratio (OR)|0.7|||||2-Sided|90.0|-5.8|7.2||||||Therapeutic equivalence of the generic estradiol vaginal cream group to the Estrace Vaginal Cream group based on the primary endpoint was evaluated in the PP population.|
1589031|NCT03293394|2921084|Superiority|||||||0.001|||||||ANOVA||||
1589032|NCT03293394|2921085|Superiority|||||||0.003|||||||ANCOVA||||
1589033|NCT03293394|2921086|Superiority|||||||0.011|||||||ANCOVA||||
1589034|NCT03293394|2921087|Superiority|||||||0.19|||||||ANCOVA||||
1589035|NCT03293394|2921088|Superiority|||||||0.652|||||||ANCOVA||||
1589036|NCT03293394|2921089|Superiority|||||||0.19|||||||ANCOVA||||
1589037|NCT03293394|2921090|Superiority|||||||0.011|||||||ANOVA||||
1589038|NCT03293394|2921091|Superiority||||||=|0|||||||ANCOVA||||
1589039|NCT03293238|2921092|Superiority|||||||0.749|||||||ANOVA||||
1589040|NCT03293238|2921093|Superiority|||||||0.527|||||||ANOVA||||
1589041|NCT03292692|2921095|Superiority||Mean Difference (Final Values)|-1.144||||0.002|2-Sided|95.0|-1.871|-0.417|||Regression, Linear||Multilevel linear modeling, with time modeled as change from pre to post.||
1589042|NCT03292692|2921096|Superiority||Mean Difference (Final Values)|-2.149|||<|0.001|2-Sided|95.0|-2.974|-1.324|||Regression, Linear|Multilevel linear regression|Multilevel linear modeling, with time modeled as change from pre-post.||
1589043|NCT03292692|2921097|Superiority||Slope|0.17|||<|0.001|2-Sided|95.0|0.105|0.235|||Regression, Linear|Multilevel linear modeling|Slope of the intervention group compared to slope of the control group||
1589044|NCT03292692|2921098|Superiority||Slope|0.372|||<|0.001|2-Sided|95.0|0.279|0.465|||Regression, Linear|Multi-level regression|Slope of intervention group compared to slope of the control group||
1589045|NCT03291197|2921124|Other|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Our study was not powered to perform statistical analysis though was still conduct to look for a trend in reduction of VAS.|
1589046|NCT03290378|2921134|Superiority||||||<|0.005|||||||ANCOVA||||
1589047|NCT03290300|2921138|Other||||||<|0.0001||||||The pre-specified threshold for statistical significance was p<0.05.|ANOVA|Repeated measures ANOVA with multiple comparisons to baseline|||
1589048|NCT03289676|2921143|Other||Odds Ratio, log|1.12||||0.029|2-Sided|95.0|1.0|1.24|||Regression, Logistic||||
1589049|NCT03289676|2921145|Superiority|||||||0.29|||||||Fisher Exact||||
1589050|NCT03287791|2921168|Superiority||Median Difference (Final Values)|-9.71||||0.0007|2-Sided|95.0|-15.28|-4.14|||ANOVA|||Analyses was performed using an ANOVA model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.|
1589051|NCT03287791|2921168|Superiority||Mean Difference (Final Values)|-11.27|||<|0.0001|2-Sided|95.0|-16.8|-5.73|||ANOVA|||Analyses was performed using an Analysis of Variance (ANOVA) model with percent change from baseline to Week 12 in the lesion count as outcome and treatment, center and treatment-by-center interaction as factors.|
1589052|NCT03286751|2921172|Superiority||Ratio of Geometric LSMeans|0.92||||0.1351|2-Sided|95.0|0.83|1.03|||Mixed Models Analysis||||
1589053|NCT03286751|2921172|Superiority||Ratio of Geometric LSMeans|0.92||||0.1578|2-Sided|95.0|0.83|1.03|||Mixed Models Analysis||||
1589054|NCT03286751|2921172|Superiority||Ratio of Geometric LSMeans|0.97||||0.5749|2-Sided|95.0|0.87|1.08|||Mixed Models Analysis||||
1589055|NCT03286751|2921173|Superiority||Ratio of Geometric LSMeans|1.03||||0.0727|2-Sided|95.0|0.997|1.07|||Mixed Models Analysis||||
1589056|NCT03286751|2921173|Superiority||Ratio of Geometric LSMeans|1.02||||0.2236|2-Sided|95.0|0.986|1.06|||Mixed Models Analysis||||
1589057|NCT03286751|2921173|Superiority||Ratio of Geometric LSMeans|1.01||||0.5495|2-Sided|95.0|0.974|1.05|||Mixed Models Analysis||||
1589058|NCT03286218|2921188|Other||LS Mean Difference|-28.8|||||2-Sided|90.0|-33.0|-24.5||||||Agitation/relaxation|
1589059|NCT03286218|2921188|Other||LS Mean Difference|-21.7|||||2-Sided|90.0|-25.9|-17.5||||||Agitation/relaxation|
1589060|NCT03286218|2921188|Other||LS Mean Difference|-19.5|||||2-Sided|90.0|-23.7|-15.3||||||Agitation/relaxation|
1589061|NCT03286218|2921188|Other||LS Mean Difference|-30.8|||||2-Sided|90.0|-35.0|-26.5||||||Agitation/relaxation|
1589062|NCT03286218|2921188|Other||LS Mean Difference|-24.8|||||2-Sided|90.0|-28.8|-20.8||||||Alertness/drowsiness|
1589063|NCT03286218|2921188|Other||LS Mean Difference|-19.6|||||2-Sided|90.0|-23.6|-15.5||||||Alertness/drowsiness|
1589064|NCT03286218|2921188|Other||LS Mean Difference|-16.9|||||2-Sided|90.0|-20.9|-12.8||||||Alertness/drowsiness|
1589065|NCT03286218|2921188|Other||LS Mean Difference|-29.9|||||2-Sided|90.0|-34.0|-25.9||||||Alertness/drowsiness|
1589066|NCT03286218|2921189|Superiority||Median Difference (Final Values)|0.0||||0.0098|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1589067|NCT03286218|2921189|Superiority||Median Difference (Final Values)|0.0||||0.0625|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1589068|NCT03286218|2921189|Superiority||Median Difference (Final Values)|0.0||||0.0781|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1589069|NCT03286218|2921189|Superiority||Mean Difference (Final Values)|0.0|||<|0.0001|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1589070|NCT03286218|2921190|Other||LS Mean Difference|58.4|||||2-Sided|90.0|50.4|66.3||||||High|
1589071|NCT03286218|2921190|Other||LS Mean Difference|47.5|||||2-Sided|90.0|39.5|55.5||||||High|
1589072|NCT03286218|2921190|Other||LS Mean Difference|34.4|||||2-Sided|90.0|26.4|42.4||||||High|
1589073|NCT03286218|2921190|Other||LS Mean Difference|68.6|||||2-Sided|90.0|60.6|76.6||||||High|
1589074|NCT03286218|2921190|Other||LS Mean Difference|64.8|||||2-Sided|90.0|56.7|73.0||||||Any effects|
1589075|NCT03286218|2921190|Other||LS Mean Difference|56.8|||||2-Sided|90.0|48.7|64.9||||||Any effects|
1589076|NCT03286218|2921190|Other||LS Mean Difference|44.9|||||2-Sided|90.0|36.8|53.0||||||Any effects|
1589077|NCT03286218|2921190|Other||LS Mean Difference|75.4|||||2-Sided|90.0|67.2|83.5||||||Any effects|
1589078|NCT03286218|2921190|Other||LS Mean Difference|12.5|||||2-Sided|90.0|5.69|19.3||||||Bad effects|
1589079|NCT03286218|2921190|Other||LS Mean Difference|7.28|||||2-Sided|90.0|0.487|14.1||||||Bad effects|
1589080|NCT03286218|2921190|Other||LS Mean Difference|5.04|||||2-Sided|90.0|-1.76|11.8||||||Bad effects|
1589081|NCT03286218|2921190|Other||LS Mean Difference|20.4|||||2-Sided|90.0|13.6|27.2||||||Bad effects|
1589082|NCT03286218|2921190|Other||LS Mean Difference|53.0|||||2-Sided|90.0|45.4|60.6||||||Good effects|
1589083|NCT03286218|2921190|Other||LS Mean Difference|52.0|||||2-Sided|90.0|44.4|59.7||||||Good effects|
1589084|NCT03286218|2921190|Other||LS Mean Difference|35.5|||||2-Sided|90.0|27.9|43.2||||||Good effects|
1589085|NCT03286218|2921190|Other||LS Mean Difference|69.7|||||2-Sided|90.0|62.1|77.4||||||Good effects|
1589086|NCT03286218|2921190|Other||LS Mean Difference|25.3|||||2-Sided|90.0|20.3|30.2||||||Take drug again|
1589087|NCT03286218|2921190|Other||LS Mean Difference|20.6|||||2-Sided|90.0|15.7|25.6||||||Take drug again|
1589088|NCT03286218|2921190|Other||LS Mean Difference|19.1|||||2-Sided|90.0|14.2|24.0||||||Take drug again|
1589089|NCT03286218|2921190|Other||LS Mean Difference|34.0|||||2-Sided|90.0|29.1|38.9||||||Take drug again|
1589096|NCT03286218|2921193|Non-Inferiority|The non-inferiority (NI) margin for Alprazolam and Lasmiditan 100 mg dose is 5 mm.|LS Mean Difference|16.8|||||2-Sided|90.0|12.8|20.8|||||||
1589097|NCT03286218|2921193|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|23.6|||||2-Sided|90.0|19.6|27.6|||||||
1589098|NCT03286218|2921193|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|20.3|||||2-Sided|90.0|16.3|24.3|||||||
1589099|NCT03286218|2921193|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses vs Placebo is 14 mm.|LS Mean Difference|15.6|||||2-Sided|90.0|11.7|19.6|||||||
1589100|NCT03286218|2921193|Non-Inferiority|The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 14 mm.|Least Squares (LS) Mean Difference|32.4|||||2-Sided|90.0|28.4|36.4|||||||
1589101|NCT03285984|2921195|Superiority||Mean Difference (Net)|-0.21|||<|0.0001|2-Sided|95.0|-0.27|-0.15||From ANCOVA model with factors for treatment group, period and subject (random effect), and subject-level baseline and period-level baseline|ANCOVA||Difference is first named treatment minus second-named treatment such that a negative difference favors the first named treatment||
1589102|NCT03285295|2921220|Other|95% Confidence Interval provided.|Point Estimate|98.65|||||2-Sided|95.0|95.2|99.84||||||Sensitivity|
1589103|NCT03285295|2921221|Other|95% Confidence Interval provided.|Point Estimate|100.0|||||2-Sided|95.0|94.87|100.0||||||Sensitivity|
1589104|NCT03285295|2921222|Other|95% Confidence Interval provided.|Point Estimate|100.0|||||2-Sided|95.0|92.75|100.0||||||Sensitivity|
1589105|NCT03285295|2921224|Other|95% Confidence Interval provided.|Point Estimate|100.0|||||2-Sided|95.0|95.98|100.0||||||Sensitivity|
1589106|NCT03285295|2921229|Other|95% Confidence Interval provided.|Point Estimate|100.0|||||2-Sided|95.0|98.85|100.0|||||||
1589107|NCT03285295|2921230|Superiority||Clinical Specificity (%)|99.98|||||2-Sided|95.0|99.94|100.0|||||||
1589108|NCT03285295|2921231|Other|95% Confidence Interval provided.|Point Estimate|100.0|||||2-Sided|95.0|99.09|100.0|||||||
1589109|NCT03285295|2921232|Superiority||Clinical Specificity (%)|99.9|||||2-Sided|95.0|99.84|99.94|||||||
1589110|NCT03285295|2921233|Other|95% Confidence Interval provided.|Point Estimate|100.0|||||2-Sided|95.0|99.72|100.0|||||||
1589111|NCT03285295|2921234|Superiority||Clinical Specificity (%)|99.92|||||2-Sided|95.0|99.87|99.96|||||||
1589112|NCT03285295|2921235|Other|95% Confidence Interval provided.|Point Estimate|100.0|||||2-Sided|95.0|99.09|100.0|||||||
1589113|NCT03285295|2921236|Superiority||Clinical Specificity (%)|99.92|||||2-Sided|95.0|99.86|99.95|||||||
1589114|NCT03285295|2921237|Other|95% Confidence Interval provided.|Point Estimate|100.0|||||2-Sided|95.0|99.48|100.0|||||||
1589115|NCT03285295|2921238|Superiority||Clinical Specificity (%)|99.99|||||2-Sided|95.0|99.95|100.0|||||||
1589116|NCT03285295|2921239|Other|95% Confidence Interval provided.|Point Estimate|100.0|||||2-Sided|95.0|99.15|100.0|||||||
1589117|NCT03285295|2921240|Superiority||Clinical Specificity (%)|99.96|||||2-Sided|95.0|99.92|99.99|||||||
1589118|NCT03282591|2921340|Superiority||Mean Difference (Final Values)|31.4||||0.9942|1-Sided|95.0||56.9|||Mixed Models Analysis||||
1589119|NCT03282240|2921351|Superiority|Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is > 10% for each applicable comparison.|Difference in Percentage|20.78|||||2-Sided|95.0|16.5|24.61||||||B Victoria: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|
1589120|NCT03282240|2921351|Superiority|Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is > 10% for each applicable comparison.|Difference in Percentage|29.27|||||2-Sided|95.0|24.78|33.29||||||B Yamagata: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.|
1589121|NCT03282240|2921353|Superiority|Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was > 1.5 for comparison group.|GMT Ratio (QIV-HD/TIV-HDs)|2.03|||||2-Sided|95.0|1.802|2.288||||||The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|
1589122|NCT03282240|2921353|Superiority|Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was > 1.5 for comparison group.|GMT Ratio (QIV-HD/TIV-HDs)|2.04|||||2-Sided|95.0|1.804|2.315||||||The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|
1589123|NCT03282240|2921354|Non-Inferiority|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is > -10%.|Difference in Percentage|-3.27|||||2-Sided|95.0|-7.37|0.86||||||A/H1N1: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.|
1589124|NCT03282240|2921354|Non-Inferiority|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is > -10%.|Difference in Percentage|-0.71|||||2-Sided|95.0|-4.83|3.42||||||A/H3N2: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.|
1589125|NCT03282240|2921354|Non-Inferiority|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is > -10%.|Difference in Percentage|-1.75|||||2-Sided|95.0|-7.04|3.53||||||B Yamagata: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.|
1589126|NCT03282240|2921354|Non-Inferiority|Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is > -10%.|Difference in Percentage|-2.41|||||2-Sided|95.0|-7.66|2.7||||||B Victoria: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.|
1589127|NCT03282240|2921355|Non-Inferiority|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is > 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|0.95|||||2-Sided|95.0|0.842|1.066||||||A/H3N2: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|
1599049|NCT02858401|2938156|Other|||||||1|||||||Fisher Exact||||
1589128|NCT03282240|2921355|Non-Inferiority|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is > 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|0.83|||||2-Sided|95.0|0.744|0.932||||||A/H1N1: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|
1589129|NCT03282240|2921355|Non-Inferiority|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is > 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|1.0|||||2-Sided|95.0|0.881|1.129||||||B Yamagata: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|
1589130|NCT03282240|2921355|Non-Inferiority|Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is > 0.667 for each of the comparisons.|GMT Ratio (QIV-HD/TIV-HDs)|1.08|||||2-Sided|95.0|0.958|1.224||||||B Victoria: The 2-sided 95% confidence interval (CI) was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.|
1589131|NCT03280615|2921396|Superiority|||||||0.043|||||||Mixed Models Analysis|||A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups|
1589132|NCT03280615|2921397|Superiority|||||||0.231|||||||Fisher Exact|||A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups|
1589133|NCT03280615|2921398|Superiority|||||||0.257|||||||Fisher Exact|||A Fisher exact test was performed|
1589134|NCT03280550|2921407|Superiority||Difference in Least Squares Means|3.81|Standard Error of the Mean|1.23||0.0024|2-Sided|95.0|1.38|6.24||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline UPSIT, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the UPSIT score at Week 24.|
1589135|NCT03280550|2921408|Superiority||Difference in Least Squares Means|-1.91|Standard Error of the Mean|0.48||0.0001|2-Sided|95.0|-2.85|-0.96||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline TNSS, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Total Nasal Symptom Score (TNSS) at Week 24.|
1589136|NCT03280550|2921409|Superiority||Odds Ratio (OR)|6.25||||0.0209|2-Sided|95.0|1.32|29.6||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in reduction in the need for surgery for nasal polyps by Week 24.|
1589137|NCT03280550|2921410|Superiority||Odds Ratio (OR)|0.61||||0.6716|2-Sided|95.0|0.05|5.51||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue treatment through Week 24.|
1589138|NCT03280550|2921411|Superiority||Odds Ratio (OR)|3.71||||0.0492|2-Sided|95.0|1.0|13.71|||Wald Chi-Square|Adjusted for Baseline AQLQ, geographic region, and aspirin sensitivity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for number of participants with a change from baseline in AQLQ score of ≥0.5 at Week 24.|
1589139|NCT03280550|2921412|Superiority||Odds Ratio (OR)|0.0||||0.4815|2-Sided|95.0|0.0|17.64||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for having had surgery for nasal polyps through Week 24.|
1589140|NCT03280550|2921413|Superiority||Odds Ratio (OR)|0.61||||0.6716|2-Sided|95.0|0.05|5.51||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue medication through Week 24.|
1589141|NCT03280550|2921414|Superiority||Difference in Least Squares Means|-0.43|Standard Error of the Mean|0.14||0.0023|2-Sided|95.0|-0.7|-0.16||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline ARS, treatment and baseline ARS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Anterior Rhinorrhea Score (ARS) at Week 24.|
1589142|NCT03280550|2921415|Superiority||Difference in Least Squares Means|-16.12|Standard Error of the Mean|2.9|<|0.0001|2-Sided|95.0|-21.86|-10.38||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the SNOT-22 score at Week 24.|
1589143|NCT03280550|2921416|Superiority||Difference in Least Squares Means|-0.57|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-0.83|-0.31||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily NCS at Week 16.|
1589144|NCT03280550|2921417|Superiority||Difference in Least Squares Means|-1.01|Standard Error of the Mean|0.21|<|0.0001|2-Sided|95.0|-1.43|-0.6||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the NPS at Week 16.|
1589145|NCT03280550|2921418|Superiority||Difference in Least Squares Means|-0.56|Standard Error of the Mean|0.14||0.0001|2-Sided|95.0|-0.84|-0.28||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline PRS, treatment and baseline PRS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Posterior Rhinorrhea Score (PRS) at Week 24.|
1589146|NCT03280550|2921419|Superiority||Difference in Least Squares Means|-0.33|Standard Error of the Mean|0.14||0.0161|2-Sided|95.0|-0.6|-0.06||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline SSS, treatment and baseline SSS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Sense of Smell Score (SSS) at Week 24.|
1589147|NCT03280550|2921420|Superiority||Difference in Least Squares Means|-0.55|Standard Error of the Mean|0.15||0.0004|2-Sided|95.0|-0.84|-0.25||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NCS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.|
1589148|NCT03280550|2921421|Superiority||Difference in Least Squares Means|-1.14|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.59|-0.69||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NPS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.|
1589149|NCT03280537|2921430|Superiority||Difference in Least Squares Means|3.86|Standard Error of the Mean|1.16||0.0011|2-Sided|95.0|1.57|6.15||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline UPSIT, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the UPSIT score at Week 24.|
1589150|NCT03280537|2921431|Superiority||Difference in Least Squares Means|-2.09|Standard Error of the Mean|0.46|<|0.0001|2-Sided|95.0|-3.0|-1.18||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline TNSS, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Total Nasal Symptom Score (TNSS) at Week 24.|
1589151|NCT03280537|2921432|Superiority||Odds Ratio (OR)|6.22||||0.0139|2-Sided|95.0|1.23|60.23||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in reduction in the need for surgery for nasal polyps by Week 24.|
1589152|NCT03280537|2921433|Superiority||Odds Ratio (OR)|0.2||||0.1594|2-Sided|95.0|0.02|1.89||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue treatment through Week 24.|
1589153|NCT03280537|2921434|Superiority||Odds Ratio (OR)|4.04||||0.0396|2-Sided|95.0|1.07|15.25|||Wald Chi-Square|Adjusted for Baseline AQLQ, geographic region, and aspirin sensitivity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for number of participants with a change from baseline in AQLQ score of ≥0.5 at Week 24.|
1589154|NCT03280537|2921435|Superiority||Odds Ratio (OR)|0.0||||1|2-Sided|95.0|0.0|20.61||Tested at the two-sided 0.05 significance level.|Fisher Exact|Unadjusted|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for having had surgery for nasal polyps through Week 24.|
1589155|NCT03280537|2921436|Superiority||Odds Ratio (OR)|0.2||||0.1594|2-Sided|95.0|0.02|1.89||Tested at the two-sided 0.05 significance level.|Wald Chi-Square|Adjusted for geographic region and asthma/aspirin sensitivity comorbidity status.|Odds ratio is comparing Omalizumab arm to Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for requirement of rescue medication through Week 24.|
1589156|NCT03280537|2921437|Superiority||Difference in Least Squares Means|-0.63|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-0.9|-0.35||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline ARS, treatment and baseline ARS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Anterior Rhinorrhea Score (ARS) at Week 24.|
1589157|NCT03280537|2921438|Superiority||Difference in Least Squares Means|-15.04|Standard Error of the Mean|3.14|<|0.0001|2-Sided|95.0|-21.26|-8.82||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline, treatment and baseline by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the SNOT-22 score at Week 24.|
1591003|NCT03161938|2925187|Superiority|||||||0.526|||||||Chi-squared, Corrected|||Day 3, fatigue|
1589158|NCT03280537|2921439|Superiority||Difference in Least Squares Means|-0.59|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-0.87|-0.3||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily NCS at Week 16.|
1589159|NCT03280537|2921440|Superiority||Difference in Least Squares Means|-0.91|Standard Error of the Mean|0.24||0.0002|2-Sided|95.0|-1.39|-0.44||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the NPS at Week 16.|
1589160|NCT03280537|2921441|Superiority||Difference in Least Squares Means|-0.54|Standard Error of the Mean|0.14||0.0001|2-Sided|95.0|-0.81|-0.27||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline PRS, treatment and baseline PRS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Posterior Rhinorrhea Score (PRS) at Week 24.|
1589161|NCT03280537|2921442|Superiority||Difference in Least Squares Means|-0.45|Standard Error of the Mean|0.14||0.0024|2-Sided|95.0|-0.73|-0.16||Tested at the two-sided 0.05 significance level.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline SSS, treatment and baseline SSS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The null hypothesis was that no difference exists between the treatment groups for change from baseline in the average daily Sense of Smell Score (SSS) at Week 24.|
1589162|NCT03280537|2921443|Superiority||Difference in Least Squares Means|-0.5|Standard Error of the Mean|0.15||0.0017|2-Sided|95.0|-0.8|-0.19||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NCS, treatment and baseline NCS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NCS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.|
1589163|NCT03280537|2921444|Superiority||Difference in Least Squares Means|-0.59|Standard Error of the Mean|0.23||0.014|2-Sided|95.0|-1.05|-0.12||Tested at the two-sided 0.05 significance level. There was no adjustment for multiplicity for the co-primary outcome measures.|Mixed-Effect Model of Repeated Measures|Adjustments: geographic region, asthma/aspirin sensitivity, treatment, timepoint, baseline NPS, treatment and baseline NPS by timepoint interactions.|Difference in least squares means: Omalizumab arm minus Placebo arm.|The primary analysis tested the null hypothesis that no treatment group difference existed for change from baseline in NPS at Week 24. As NPS and NCS are co-primary outcome measures, both null hypotheses for NPS and NCS must be rejected, with parameter estimates indicating a benefit of omalizumab over placebo, for the study to be deemed positive.|
1589164|NCT03280108|2921449|Superiority||Mantel-Haenszel common difference|71.2|||||2-Sided|95.0|61.87|80.46|||||||
1589165|NCT03280108|2921450|Superiority||Least Squares Mean Difference|-0.257|Standard Error of the Mean|0.0153|<|0.001|2-Sided|95.0|-0.287|-0.227|||Mixed Models Analysis||||
1589166|NCT03280108|2921456|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1589167|NCT03280108|2921457|Non-Inferiority|Non-inferiority based on the observed 95% Upper Confidence Limit of the difference in Least Squares Means (LSM) between the 2 groups (TFNT00 - SN60AT). Non-inferiority margin = 0.10 logMAR.|Least Squares Mean Difference|0.024|Standard Error of the Mean|0.0103|||1-Sided|95.0||0.041|||||||
1589168|NCT03279458|2921458|Other|least square regression analysis|correlation coefficient (R)|0.94|||<|0.05|2-Sided|95.0|0.88|0.97|||Regression, Linear||||
1589169|NCT03277274|2921612|Other|TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.023|||||||ANOVA||||
1589170|NCT03277274|2921612|Other|TAK-954 (Free): An ANOVA were performed on log transformed AUCinf (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.201|||||||ANOVA||||
1589171|NCT03277274|2921612|Other|TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.029|||||||ANOVA||||
1589172|NCT03277274|2921612|Other|TAK-954 (Total): An ANOVA were performed on log transformed AUCinf (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.138|||||||ANOVA||||
1589173|NCT03277274|2921613|Other|TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.023|||||||ANOVA||||
1589174|NCT03277274|2921613|Other|TAK-954 (Free): An ANOVA were performed on log transformed AUClast (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.129|||||||ANOVA||||
1589175|NCT03277274|2921613|Other|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.017|||||||ANOVA||||
1589176|NCT03277274|2921613|Other|TAK-954 (Total): An ANOVA were performed on log transformed AUClast (Total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.151|||||||ANOVA||||
1589177|NCT03277274|2921614|Other|TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.031|||||||ANOVA||||
1589178|NCT03277274|2921614|Other|TAK-954 (Free): An ANOVA were performed on log transformed Cmax (Free TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.02|||||||ANOVA||||
1599050|NCT02858401|2938156|Other|||||||1|||||||Fisher Exact||||
1589179|NCT03277274|2921614|Other|TAK-954 (Total): An ANOVA were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.026|||||||ANOVA||||
1589180|NCT03277274|2921614|Other|TAK-954 (Total): An analysis of variance (ANOVA) were performed on log transformed Cmax (total TAK-954) to compare each hepatically impaired group with the normal hepatic function group.||||||0.579|||||||ANOVA||||
1589181|NCT03275870|2921644|Other|||||||0.213||||||P value of <0.05 used as threshold for significance|t-test, 2 sided||||
1589182|NCT03275870|2921645|Other|||||||0.042||||||p value <0.05 used as threshold for significance|t-test, 2 sided||||
1589183|NCT03274986|2921651|Other||Difference in percentage|18.0|||||2-Sided|95.0|9.65|27.37|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).||
1589184|NCT03274986|2921652|Superiority||Least Squares Mean Difference|-0.156|Standard Error of the Mean|0.0206|<|0.001|2-Sided|95.0|-0.197|-0.115||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)||
1589185|NCT03274986|2921656|Other||Difference in depth of focus|0.54|||||2-Sided||||||||Difference in depth of focus (DFT015 - SN60WF)||
1589186|NCT03274986|2921657|Non-Inferiority|Non-Inferiority margin was 0.1 logMAR.|Least Squares Mean Difference|0.052|Standard Error of the Mean|0.0127|||1-Sided|95.0||0.073|||||Least squares mean difference (DFT015 - SN60WF). The 1-sided 95% Upper Confidence Limit is presented.||
1589187|NCT03274986|2921658|Superiority||Least Squares Mean Difference|-0.164|Standard Error of the Mean|0.0168|<|0.001|2-Sided|95.0|-0.197|-0.131||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)||
1589188|NCT03274518|2921664|Non-Inferiority|The lower the ECW/TBW ratio, the lower pre-dialysis excess fluid. A non-inferiority margin was defined as difference within 10% from reference method (olHDF)||||||0.045|||||||t-test, 2 sided||||
1589189|NCT03274518|2921665|Non-Inferiority|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.3054|||||||t-test, 2 sided||||
1589190|NCT03274518|2921666|Non-Inferiority|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.1179|||||||t-test, 2 sided||||
1589191|NCT03274518|2921667|Non-Inferiority|The non-inferiority margin was defined as difference within 20% in comparison to reference method (olHDF)||||||0.4534|||||||t-test, 2 sided||||
1589192|NCT03274076|2921669|Superiority|||||||0.9212|||||||Exact Wilcoxon|||H0: The CRISS score at week 48 in placebo = The CRISS score at week 48 in Tofacitinib.|
1589193|NCT03274076|2921669|Superiority|||||||0.8392|||||||Exact Wilcoxon|||H0: The CRISS score at week 24 in placebo = The CRISS score at week 24 in Tofacitinib.|
1589194|NCT03274076|2921669|Superiority|||||||0.4535|||||||Exact Wilcoxon|||H0: The CRISS score at week 12 in placebo = The CRISS score at week 12 in Tofacitinib.|
1589195|NCT03274076|2921670|Superiority|||||||0.6|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 48 in placebo = The absolute change in mRSS from week 0 to week 48 in Tofacitinib.|
1589196|NCT03274076|2921670|Superiority|||||||0.3063|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 36 in placebo = The absolute change in mRSS from week 0 to week 36 in Tofacitinib.|
1589197|NCT03274076|2921670|Superiority|||||||0.4665|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 24 in placebo = The absolute change in mRSS from week 0 to week 24 in Tofacitinib.|
1589198|NCT03274076|2921670|Superiority|||||||0.1978|||||||Exact Wilcoxon|||H0: The absolute change in mRSS from week 0 to week 12 in placebo = The absolute change in mRSS from week 0 to week 12 in Tofacitinib.|
1589199|NCT03274076|2921671|Superiority||Rate ratio|1.87|||||2-Sided|90.0|0.5169|6.7652|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of adverse events of special interest throughout week 48 in Placebo = Rate of adverse events of special interest throughout week 48 in Tofacitinib|
1589200|NCT03274076|2921671|Superiority||Rate ratio|3.85|||||2-Sided|90.0|0.68|21.77|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of adverse events of special interest throughout week 36 in Placebo = Rate of adverse events of special interest throughout week 36 in Tofacitinib|
1589201|NCT03274076|2921672|Superiority||Rate ratio|0.89|||||2-Sided|90.0|0.52|1.52|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 48 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 48 in Tofacitinib|
1589202|NCT03274076|2921672|Superiority||Rate ratio|0.85|||||2-Sided|90.0|0.49|1.49|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 36 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 36 in Tofacitinib|
1589203|NCT03274076|2921672|Superiority||Rate ratio|0.53|||||2-Sided|90.0|0.26|1.07|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 24 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 24 in Tofacitinib|
1589204|NCT03274076|2921672|Superiority||Rate ratio|0.65|||||2-Sided|90.0|0.25|1.71|||||Tofacitinib represents the numerator, and Placebo represents the denominator.|H0: Rate of grade 2 (moderate) or higher adverse events that occur throughout week 12 in Placebo = Rate of grade 2 (moderate) or higher adverse events that occur throughout week 12 in Tofacitinib|
1589205|NCT03274076|2921673|Superiority||Rate ratio|1.25|||||2-Sided|90.0|0.19|8.33|||||Tofacitinib represents the numerator, and placebo represents the denominator.|H0: Rate of grade 3 (severe) or higher adverse events that occur throughout week 48 in Placebo = Rate of grade 3 (severe) or higher adverse events that occur throughout week 48 in Tofacitinib.|
1589206|NCT03273387|2921680|Superiority|||||||0.0002||||||95% Confidence interval 15.92 to 42.53 statistical significant if p <0.05|t-test, 2 sided|t=4.598 df=19|||
1589207|NCT03273387|2921681|Superiority|||||||0.33||||||statistical significant if p <0.05|two-way ANOVA|DF=3|||
1589208|NCT03273387|2921682|Superiority|||||||0.008||||||95% Confidence interval 1.97 - 11.3 statistical significant if p<0.05|t-test, 2 sided|t=2.988 df=18|||
1589346|NCT03259087|2922185|Other||Geometric Least Squares Mean Ratio (GMR)|0.94|||||2-Sided|90.0|0.75|1.2|||||GMR is ratio of Experimental Group / Healthy Group||
1589209|NCT03270644|2921703|Other||Difference of LSMeans|3.47|||||2-Sided|90.0|1.99|4.95||||||Diastolic blood pressure was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.|
1589210|NCT03270644|2921704|Other||Difference of LSMeans|5.57|||||2-Sided|90.0|3.57|7.57||||||Systolic blood pressure was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.|
1589211|NCT03270644|2921705|Other||Difference of LSMeans|-3.51|||||2-Sided|90.0|-6.39|-0.64||||||PR interval was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.|
1589212|NCT03270644|2921706|Other||Ratio of Geometric LSMeans|0.999|||||2-Sided|90.0|0.967|1.03||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.|
1589213|NCT03270644|2921707|Other||Ratio of Geometric LSMeans|1.01|||||2-Sided|90.0|0.967|1.04||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.|
1589214|NCT03270644|2921708|Other||Ratio of Geometric LSMeans|0.958|||||2-Sided|90.0|0.917|1.0||||||Ratio of geometric LSMeans of Cmax used a mixed-effects repeated measures model adjusted for fixed effects for treatment, time point, time point by treatment, and random effect for subjects.|
1589215|NCT03270644|2921709|Other||Ratio of Geometric LSMeans|0.884|||||2-Sided|90.0|0.832|0.939||||||Log-transformed PK parameters were evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.|
1589216|NCT03270644|2921710|Other||Difference of LSMeans|-5.45|||||2-Sided|90.0|-7.27|-3.64||||||Mean hourly HR was evaluated in a linear mixed-effects model with a fixed effect for treatment and a random effect for subject.|
1589217|NCT03270085|2921711|Superiority|||||||0.91|||||||Wilcoxon (Mann-Whitney)||||
1589218|NCT03270085|2921712|Superiority|||||||0.81|||||||Wilcoxon (Mann-Whitney)||||
1589219|NCT03270085|2921713|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1589220|NCT03268941|2921722|Other||Hodges-Lehmann Estimate of Median Diff|-24.49||||0.382|2-Sided|95.0|-225.87|98.91||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE on time measured by the SmartPill Day 7 in Part 1.|
1589221|NCT03268941|2921722|Other||Hodges-Lehmann Estimate of Median Diff|-26.95||||0.481|2-Sided|95.0|-229.73|530.49||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.|
1589222|NCT03268941|2921722|Other||Hodges-Lehmann Estimate of Median Diff|-18.14||||0.274|2-Sided|95.0|-307.58|13.56||P-value was obtained with pairwise Wilcoxon Rank Sum tests.|Wilcoxon Rank Sum tests|||Percent Change in GE time measured by the SmartPill on Day 7 in Part 1.|
1589223|NCT03268941|2921723|Other||LS Mean Difference|7.0|Standard Error of the Mean|11.654||0.551|2-Sided|95.0|-16.52|30.52||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.|
1589224|NCT03268941|2921723|Other||LS Mean Difference|12.92|Standard Error of the Mean|12.143||0.293|2-Sided|95.0|-11.58|37.43||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.|
1589225|NCT03268941|2921723|Other||LS Mean Difference|7.56|Standard Error of the Mean|11.708||0.522|2-Sided|95.0|-16.06|31.19||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 1 in Part 1.|
1589226|NCT03268941|2921724|Other||LS Mean Difference|8.05|Standard Error of the Mean|15.45||0.605|2-Sided|95.0|-23.22|39.33||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.|
1589227|NCT03268941|2921724|Other||LS Mean Difference|6.28|Standard Error of the Mean|15.469||0.687|2-Sided|95.0|-25.04|37.59||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.|
1589228|NCT03268941|2921724|Other||LS Mean Difference|7.76|Standard Error of the Mean|14.648||0.599|2-Sided|95.0|-21.89|37.41||P-value was obtained by ANCOVA model with treatment and underlying disease (DG/IG) condition as fixed factors and baseline score as covariate.|ANCOVA|||Change from Baseline in GEBT gastric half-emptying time on Day 7 in Part 1.|
1589229|NCT03268941|2921725|Other||LS Mean Difference|12.8|||<|0.001|2-Sided|95.0|6.94|23.59||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration - covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.|
1589230|NCT03268941|2921725|Other||LS Mean Difference|11.24|||<|0.001|2-Sided|95.0|5.91|21.41||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.|
1589231|NCT03268941|2921725|Other||Least Square (LS) Mean Difference|7.38|||<|0.001|2-Sided|95.0|4.03|13.52||ANCOVA model was used for analysis. Treatment, underlying disease (DG/IG) were fixed factors. ln of baseline prolactin concentration as covariate, ln of ratio of Cmax to baseline concentration as response. Results in original scale are presented.|ANCOVA|||Change in serum prolactin on Day 1 at the Tmax as a ratio of Cmax to serum prolactin concentration at Baseline.|
1589232|NCT03268590|2921742|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1589233|NCT03268590|2921743|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1589234|NCT03268590|2921744|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1589235|NCT03268343|2921747|Superiority||Geometric LS Mean Ratio (%)|104.75|||||2-Sided|95.0|98.97|110.87|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).||
1589395|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2657|||<|0.001|2-Sided|95.0|0.1713|0.3601|||ANOVA|||30 min|
1589236|NCT03268343|2921751|Superiority||Geometric LS Mean Ratio (%)|96.52|||||2-Sided|90.0|93.3|99.85|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).||
1589237|NCT03268343|2921752|Superiority||Median Difference (Final Values)|1.38|||<|0.0001|2-Sided|95.0|0.5|2.25|||Wilcoxon Signed-Rank test||Hodges-Lehmann method||
1589238|NCT03268343|2921753|Superiority||Geometric LS Mean Ratio (%)|97.04|||||2-Sided|90.0|94.2|99.98|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).||
1589239|NCT03268343|2921754|Superiority||Geometric LS Mean Ratio (%)|74.71|||||2-Sided|90.0|66.39|84.08|||||fed / fasted; results obtained using an ANOVA with fixed effects of treatment, period, sequence and participant (sequence).||
1589240|NCT03268005|2921806|Non-Inferiority|The upper limit of the 95% confidence interval for the difference between faster aspart and NovoRapid was compared to a non-inferiority margin of 0.4%. If it was below or equal to 0.4% non-inferiority was considered established and effect demonstrated.|Treatment difference|-0.04||||0.31|2-Sided|95.0|-0.11|0.03|||ANOVA||Faster aspart-NovoRapid|Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, region and metformin use at baseline (Yes/No) as factors, and baseline HbA1c as a covariate.|
1589241|NCT03267511|2921844|Other||Difference of Least Square mean|-0.07|Standard Error of the Mean|0.128||0.568|2-Sided|95.0|-0.33|0.18|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1589242|NCT03267511|2921845|Other||Difference of Least Square mean|0.06|Standard Error of the Mean|0.128||0.6499|2-Sided|95.0|-0.19|0.31|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1589243|NCT03267511|2921846|Other||Difference of Least Square mean|-0.07|Standard Error of the Mean|0.128||0.568|2-Sided|95.0|-0.33|0.18|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|-0.33 to 0.18||
1589244|NCT03267511|2921846|Other||Difference of Least Mean Square|0.06|Standard Error of the Mean|0.128||0.6499|2-Sided|95.0|-0.19|0.31|||ANCOVA|From ANCOVA with treatment as fixed effect and baseline overall MLSI score as a covariate.|||"The reason for entering same analysis for primary and secondary is because statistical analysis was not done separately for primary outcome measure.~The decision was clinical decision at the time of protocol design.There was no comparisons for the primary objective as the main objective was to look at the rank order of the treatments in level of stain reduction after 8 weeks of treatment. This was achieved via the adjusted means and confidence intervals for the means along with plots of MLSI over time. The hypothesis was that the test products would reduce stain to a greater extent than the reference products. Two comparisons of interest were done under secondary and exploratory objectives."
1589245|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|12.0|||||2-Sided|95.0|0.5|23.5||||||Eae of Use|
1589246|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|20.2|||||2-Sided|95.0|7.4|33.1||||||Injection Pain|
1589247|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|11.0|||||2-Sided|95.0|-0.5|22.4||||||Anxiety Associated with a Needle Stick Injury|
1589248|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|15.1|||||2-Sided|95.0|2.1|28.1||||||Overall Comfort|
1589249|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|17.7|||||2-Sided|95.0|6.7|28.8||||||Ease of Use|
1589250|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|7.0|||||2-Sided|95.0|-5.3|19.4||||||Injection Pain|
1589287|NCT03261167|2922074|Other||Mean Difference (Net)|-0.15|||||2-Sided|95.0|-0.37|0.08|||||Week 6. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589347|NCT03259087|2922185|Other||Geometric Least Squares Mean Ratio (GMR)|0.99|||||2-Sided|90.0|0.85|1.16|||||GMR is ratio of Experimental Group / Healthy Group||
1589251|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|12.9|||||2-Sided|95.0|1.9|23.8||||||Anxiety Associated with a Needle stick injury|
1589252|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|8.4|||||2-Sided|95.0|-4.0|20.9||||||Overall Comfort|
1589253|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|18.4|||||2-Sided|95.0|4.9|31.9||||||Ease of Use|
1589254|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|18.6|||||2-Sided|95.0|3.6|33.7||||||Injection Pain|
1589255|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|19.4|||||2-Sided|95.0|6.0|32.8||||||Anxiety Associated with a needle stick|
1589256|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|20.7|||||2-Sided|95.0|5.3|36.1||||||Overall Comfort|
1589257|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|30.7|||||2-Sided|95.0|19.3|42.1||||||Ease of Use|
1589258|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|16.1|||||2-Sided|95.0|3.4|28.8||||||Injection Pain|
1589259|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|20.2|||||2-Sided|95.0|8.9|31.6||||||Anxiety Associated with a needle stick injury|
1589260|NCT03267264|2921847|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|27.8|||||2-Sided|95.0|14.9|40.7||||||Overall Comfort|
1589261|NCT03267264|2921848|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|19.7|||||2-Sided|95.0|13.8|25.7||||||Ease of Use|
1589262|NCT03267264|2921848|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|15.5|||||2-Sided|95.0|8.9|22.1||||||Injection Pain|
1589288|NCT03261167|2922074|Other||Mean Difference (Net)|-0.16|||||2-Sided|95.0|-0.42|0.09|||||Week 4. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589263|NCT03267264|2921848|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|15.9|||||2-Sided|95.0|9.9|21.8||||||Anxiety Associated with a Needle Stick Injury|
1589264|NCT03267264|2921848|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall mean|18.0|||||2-Sided|95.0|11.3|24.7||||||Overall Comfort|
1589265|NCT03267264|2921849|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|12.8|||||2-Sided|95.0|-1.1|26.7|||||||
1589266|NCT03267264|2921849|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|overal mean|6.2|||||2-Sided|95.0|-7.2|19.5|||||||
1589267|NCT03267264|2921849|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall|20.6|||||2-Sided|95.0|4.1|37.1|||||||
1589268|NCT03267264|2921849|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|30.5|||||2-Sided|95.0|16.8|44.3|||||||
1589269|NCT03267264|2921850|Non-Inferiority|Two-sided 95% confidence intervals is calculated for the average relative rating. A linear model was used to evaluate the pen needle group effect on the response to test whether the groups can be combined (a p-value < 0.05 for the pen needle group effect indicates non-poolability) and to adjust for the order effect. The order of the pen needles used and the group to which the subject belongs were used as covariates. If the lower bound of the CI is > -10mm, we can conclude in non-inferiority.|Overall Mean|17.5|||||2-Sided|95.0|10.3|24.7|||||||
1589270|NCT03265600|2921952|Superiority||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: 0.75|||
1589271|NCT03265600|2921953|Superiority||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: -0.58|||
1589272|NCT03265600|2921954|Superiority|||||||0.26|||||||Mixed Models Analysis|Cohen's d: 0.22|||
1589273|NCT03265600|2921955|Superiority|||||||0.31|||||||Mixed Models Analysis|Cohen's d: 0.15|||
1589274|NCT03265600|2921956|Superiority|||||||0.03|||||||Mixed Models Analysis|Cohen's d: 0.41|||
1589275|NCT03265600|2921957|Superiority||||||<|0.001|||||||Mixed Models Analysis|Cohen's d: 0.57|||
1589276|NCT03265600|2921958|Superiority|||||||0.08|||||||Mixed Models Analysis|Cohen's d: -0.34|||
1589277|NCT03265600|2921959|Superiority|||||||0.12|||||||Mixed Models Analysis|Cohen's d: -0.36|||
1589278|NCT03265600|2921960|Superiority|||||||0.19|||||||Mixed Models Analysis|Cohen's d: -0.25|||
1589279|NCT03265600|2921961|Superiority||Odds Ratio (OR)|2.91||||0.006|2-Sided||||||Unadjusted bivariate logistic regression||||
1589280|NCT03265132|2922011|Superiority||Risk Difference (RD)|1.0||||0.0022|2-Sided|95.0|0.42|1.0|||Fisher Exact||||
1589281|NCT03264157|2922023|Non-Inferiority|The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.|lower 95% CI|0.0||||0|2-Sided|95.0|0.0|0.0|||Farrington and Manning test||For Day 14, all subjects achieved the endpoint (RVNA titer > LLOQ). Since the statistic to measure the performance is a proportion, the proportion is 1 and no variance is calculable.||
1589282|NCT03264157|2922024|Non-Inferiority|The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.|lower 95% CI|-0.05||||0.0006|2-Sided|95.0|-0.05|0.1|||Farrington and Manning test||||
1589283|NCT03264157|2922025|Superiority||95% CI|0.97|||||2-Sided||||||||Data analyzed as log normal. The value presented is the untransformed value of the difference between means.||
1589284|NCT03264157|2922026|Non-Inferiority|The prespecified non inferiority margin was 20%. The lower bound of the 95% CI required should be greater than 0.8 to conclude non-inferiority.|lower 95% CI|0.74|||||2-Sided|95.0|0.74|0.94|||||||
1589285|NCT03264157|2922027|Non-Inferiority|The null hypothesis is p-p0 ≤ -0.1. The alternative hypothesis is p-p0 > -0.1, where p is the proportion of subjects with anti-rabies titer of >0.5 IU/mL at Day 14 in subjects receiving BPL HRIG + vaccine and p0 is the proportion receiving comparator HRIG + vaccine. We reject the null hypothesis at the one-sided 0.025 significance level, and conclude that p-p0 > -0.1, if the lower bound of an exact 95% binomial confidence interval exceeds -0.1.|lower 95% CI|-0.05||||0.0006|1-Sided|95.0|-0.05|||The threshold for this test is <=0.025.|Farrington and Manning test||||
1589286|NCT03261167|2922074|Other||Mean Difference (Net)|-0.28|||||2-Sided|95.0|-0.52|-0.04|||||Week 12. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589289|NCT03261167|2922074|Other||Mean Difference (Net)|-0.24|||||2-Sided|95.0|-0.48|0.0|||||Week 2. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.||
1589290|NCT03261167|2922075|Other||Mean Difference (Net)|0.08|||||2-Sided|95.0|-0.31|0.47|||||Week 12, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589291|NCT03261167|2922075|Other||Mean Difference (Net)|0.03|||||2-Sided|95.0|-0.33|0.38|||||Week 6, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589292|NCT03261167|2922075|Other||Mean Difference (Net)|0.14|||||2-Sided|95.0|-0.23|0.51|||||Week 4, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589293|NCT03261167|2922075|Other||Mean Difference (Net)|0.28|||||2-Sided|95.0|-0.08|0.63|||||Week 2, Thumb flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589294|NCT03261167|2922075|Other||Mean Difference (Net)|0.05|||||2-Sided|95.0|-0.25|0.34|||||Week 12, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.||
1589295|NCT03261167|2922075|Other||Mean Difference (Net)|-0.14|||||2-Sided|95.0|-0.2|0.48|||||Week 6, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interaction, Baseline, and Baseline by visit interaction as fixed effects.||
1589296|NCT03261167|2922075|Other||Mean Difference (Net)|0.17|||||2-Sided|95.0|-0.17|0.52|||||Week 4, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589297|NCT03261167|2922075|Other||Mean Difference (Net)|0.1|||||2-Sided|95.0|-0.23|0.43|||||Week 2, Finger flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589298|NCT03261167|2922075|Other||Mean Difference (Net)|0.09|||||2-Sided|95.0|-0.19|0.38|||||Week 12, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589299|NCT03261167|2922075|Other||Mean Difference (Net)|-0.02|||||2-Sided|95.0|-0.37|0.33|||||Week 6, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589300|NCT03261167|2922075|Other||Mean Difference (Net)|0.11|||||2-Sided|95.0|-0.25|0.46|||||Week 4, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589301|NCT03261167|2922075|Other||Mean Difference (Net)|0.08|||||2-Sided|95.0|-0.27|0.42|||||Week 2, Wrist flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589302|NCT03261167|2922075|Other||Mean Difference (Net)|-0.27|||||2-Sided|95.0|-0.51|-0.02|||||Week 12, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589303|NCT03261167|2922075|Other||Mean Difference (Net)|-0.37|||||2-Sided|95.0|-0.71|-0.04|||||Week 6, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589304|NCT03261167|2922075|Other||Mean Difference (Net)|-0.42|||||2-Sided|95.0|-0.71|-0.13|||||Week 4, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589305|NCT03261167|2922075|Other||Mean Difference (Net)|-0.48|||||2-Sided|95.0|-0.75|-0.22|||||Week 2, Elbow flexion. Analysis method was MMRM with Treatment, Visit, Treatment by visit interation, Baseline, and Baseline by visit interaction as fixed effects.||
1589306|NCT03261167|2922076|Other||Adjusted rate difference|-0.5|||||2-Sided|95.0|-18.8|17.9|||||Week 12, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589307|NCT03261167|2922076|Other||Adjusted rate difference|-1.5|||||2-Sided|95.0|-18.8|15.7|||||Week 6, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589308|NCT03261167|2922076|Other||Adjusted rate difference|-6.7|||||2-Sided|95.0|-23.6|10.3|||||Week 4, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589309|NCT03261167|2922076|Other||Adjusted rate difference|-9.9|||||2-Sided|95.0|-26.4|6.5|||||Week 2, Thumb flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589310|NCT03261167|2922076|Other||Adjusted rate difference|-0.1|||||2-Sided|95.0|-17.7|17.4|||||Week 12, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589311|NCT03261167|2922076|Other||Adjusted rate difference|-8.9|||||2-Sided|95.0|-23.8|6.0|||||Week 6, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589312|NCT03261167|2922076|Other||Adjusted rate difference|-10.4|||||2-Sided|95.0|-24.3|3.4|||||Week 4, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589313|NCT03261167|2922076|Other||Adjusted rate difference|-8.6|||||2-Sided|95.0|-21.9|4.7|||||Week 2, Finger flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589314|NCT03261167|2922076|Other||Adjusted rate difference|-9.6|||||2-Sided|95.0|-27.2|7.9|||||Week 12, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589315|NCT03261167|2922076|Other||Adjusted rate difference|-12.1|||||2-Sided|95.0|-27.5|3.2|||||Week 6, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589316|NCT03261167|2922076|Other||Adjusted rate difference|-8.6|||||2-Sided|95.0|-23.0|5.9|||||Week 4, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589317|NCT03261167|2922076|Other||Adjusted rate difference|-5.6|||||2-Sided|95.0|-20.9|9.8|||||Week 2, Wrist flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589341|NCT03259087|2922180|Other||Geometric Least Squares Mean Ratio (GMR)|0.3|||||2-Sided|90.0|0.21|0.43|||||GMR is ratio of Experimental Group / Healthy Group||
1589318|NCT03261167|2922076|Other||Adjusted rate difference|12.9|||||2-Sided|95.0|-4.2|30.1|||||Week 12, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589319|NCT03261167|2922076|Other||Adjusted rate difference|18.4|||||2-Sided|95.0|1.3|35.5|||||Week 6, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589320|NCT03261167|2922076|Other||Adjusted rate difference|21.7|||||2-Sided|95.0|4.9|38.5|||||Week 4, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589321|NCT03261167|2922076|Other||Adjusted rate difference|33.1|||||2-Sided|95.0|17.0|49.2|||||Week 2, Elbow flexion. Analysis was based on the Mantel-Haenszel method using Baseline MAS score of the elbow flexors.||
1589322|NCT03261167|2922077|Other||Difference|18.1|||||2-Sided|95.0|1.1|35.0|||||||
1589323|NCT03260205|2922140|Superiority||Difference in Least Mean Square|-0.6||||0.0074|2-Sided|95.0|-1.03|-0.16|||MMRM|||This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline Visits, with the CGI-I score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline CGI-S as covariate.|
1589324|NCT03260205|2922141|Superiority||Difference in Least Square Mean|-5.9||||0.0242|2-Sided|95.0|-11.01|-0.78|||MMRM|||This outcome measure was analyzed using the linear mixed-effects model for repeated measures (MMRM). From a MMRM analysis over all post-baseline visits, with the change from baseline in ADHD-RS-IV preschool version total score as the outcome, treatment, visit, and treatment-by-visit interaction as fixed effect, baseline ADHD-RS-IV and baseline ADHD-RS-IV score-by-visit interaction as covariates.|
1589325|NCT03259555|2922143|Superiority||Treatment difference|0.14|||=|0|2-Sided|95.0|-1.74|2.03|||Mixed-effect Model Repeated Measure|"An unstructured covariance was used."|"Comparison between treatment groups was carried out using MMRM, with study center, treatment group, visit, and treatment group-by-visit interaction as factor and baseline-by-visit interaction as a covariate. An unstructured covariance was used."||
1589326|NCT03259490|2922144|Other||Adjusted gmean ratio T/R (%)|97.3|Standard Deviation|13.2|||2-Sided|95.0|91.65|103.29|||||The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.|
1589327|NCT03259490|2922145|Other||Adjusted gmean ratio T/R (%)|100.17|Standard Deviation|10.1|||2-Sided|95.0|95.68|104.86|||||The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.|
1589328|NCT03259490|2922146|Other||Adjusted gmean ratio T/R (%)|103.11|Standard Deviation|5.9|||2-Sided|95.0|100.38|105.92|||||The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.|
1589329|NCT03259490|2922147|Other||Adjusted gmean ratio T/R (%)|97.17|Standard Deviation|10.6|||2-Sided|95.0|92.63|101.93|||||The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.|
1589330|NCT03259490|2922148|Other||Adjusted gmean ratio T/R (%)|107.78|Standard Deviation|11.0|||2-Sided|95.0|102.52|113.31|||||The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.|
1589331|NCT03259490|2922149|Other||Adjusted gmean ratio T/R (%)|99.95|Standard Deviation|12.4|||2-Sided|95.0|94.52|105.7|||||The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.|
1589332|NCT03259490|2922150|Other||Adjusted gmean ratio T/R (%)|100.31|Standard Deviation|8.2|||2-Sided|95.0|96.65|104.1|||||The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.|
1589333|NCT03259490|2922151|Other||Adjusted gmean ratio T/R (%)|100.35|Standard Deviation|9.5|||2-Sided|95.0|96.11|104.77|||||The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.|
1589334|NCT03259490|2922152|Other||Adjusted gmean ratio T/R (%)|103.06|Standard Deviation|5.8|||2-Sided|95.0|100.36|105.83|||||The standard deviation is actually intra-individual geometric co-efficient of variation (gCV)|The assessment of bioequivalence was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test/reference) for the endpoints using an acceptance range of 80.00 to 125.00%.|
1589335|NCT03259087|2922178|Other||Geometric Least Squares Mean Ratio (GMR)|0.3|||||2-Sided|90.0|0.21|0.43|||||GMR is ratio of Experimental Group / Healthy Group||
1589336|NCT03259087|2922178|Other||Geometric Least Squares Mean Ratio (GMR)|0.64|||||2-Sided|90.0|0.47|0.88|||||GMR is ratio of Experimental Group / Healthy Group||
1589337|NCT03259087|2922178|Other||Geometric Least Squares Mean Ratio (GMR)|0.9|||||2-Sided|90.0|0.74|1.11|||||GMR is ratio of Experimental Group / Healthy Group||
1589338|NCT03259087|2922179|Other||Geometric Least Squares Mean Ratio (GMR)|0.13|||||2-Sided|90.0|0.08|0.22|||||GMR is ratio of Experimental Group / Healthy Group||
1589339|NCT03259087|2922179|Other||Geometric Least Squares Mean Ratio (GMR)|0.4|||||2-Sided|90.0|0.31|0.53|||||GMR is ratio of Experimental Group / Healthy Group||
1589340|NCT03259087|2922179|Other||Geometric Least Squares Mean Ratio (GMR)|0.75|||||2-Sided|90.0|0.57|0.98|||||GMR is ratio of Experimental Group / Healthy Group||
1589393|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2819|||<|0.001|2-Sided|95.0|0.1875|0.3763|||ANOVA|||2 hours|
1589348|NCT03259087|2922186|Other||Geometric Least Squares Mean Ratio (GMR)|0.94|||||2-Sided|90.0|0.75|1.2|||||GMR is ratio of Experimental Group / Healthy Group||
1589349|NCT03259087|2922186|Other||Geometric Least Squares Mean Ratio (GMR)|0.98|||||2-Sided|90.0|0.84|1.14|||||GMR is ratio of Experimental Group / Healthy Group||
1589350|NCT03259087|2922187|Other||Geometric Least Squares Mean Ratio (GMR)|1.09|||||2-Sided|90.0|0.95|1.25|||||GMR is ratio of Experimental Group / Healthy Group||
1589351|NCT03259087|2922187|Other||Geometric Least Squares Mean Ratio (GMR)|2.61|||||2-Sided|90.0|2.23|3.06|||||GMR is ratio of Experimental Group / Healthy Group||
1589352|NCT03259087|2922188|Other||Geometric Least Squares Mean Ratio (GMR)|1.46|||||2-Sided|90.0|1.22|1.75|||||GMR is ratio of Experimental Group / Healthy Group||
1589353|NCT03259087|2922188|Other||Geometric Least Squares Mean Ratio (GMR)|3.63|||||2-Sided|90.0|3.03|4.36|||||GMR is ratio of Experimental Group / Healthy Group||
1589354|NCT03259087|2922189|Other||Geometric Least Squares Mean Ratio (GMR)|1.58|||||2-Sided|90.0|1.3|1.92|||||GMR is ratio of Experimental Group / Healthy Group||
1589355|NCT03259087|2922189|Other||Geometric Least Squares Mean Ratio (GMR)|3.97|||||2-Sided|90.0|3.26|4.82|||||GMR is ratio of Experimental Group / Healthy Group||
1589356|NCT03259087|2922193|Other||Geometric Least Squares Mean Ratio (GMR)|0.34|||||2-Sided|90.0|0.25|0.45|||||GMR is ratio of Experimental Group / Healthy Group||
1589357|NCT03259087|2922193|Other||Geometric Least Squares Mean Ratio (GMR)|0.59|||||2-Sided|90.0|0.49|0.7|||||GMR is ratio of Experimental Group / Healthy Group||
1589358|NCT03259087|2922193|Other||Geometric Least Squares Mean Ratio (GMR)|0.8|||||2-Sided|90.0|0.68|0.94|||||GMR is ratio of Experimental Group / Healthy Group||
1589359|NCT03259087|2922195|Other||Geometric Least Squares Mean Ratio (GMR)|1.11|||||2-Sided|90.0|0.95|1.29|||||GMR is ratio of Experimental Group / Healthy Group||
1589360|NCT03259087|2922195|Other||Geometric Least Squares Mean Ratio (GMR)|1.03|||||2-Sided|90.0|0.9|1.18|||||GMR is ratio of Experimental Group / Healthy Group||
1589361|NCT03259087|2922195|Other||Geometric Least Squares Mean Ratio (GMR)|0.99|||||2-Sided|90.0|0.84|1.16|||||GMR is ratio of Experimental Group / Healthy Group||
1589362|NCT03259087|2922196|Other||Geometric Least Squares Mean Ratio (GMR)|2.32|||||2-Sided|90.0|1.82|2.97|||||GMR is ratio of Experimental Group / Healthy Group||
1589363|NCT03259087|2922196|Other||Geometric Least Squares Mean Ratio (GMR)|1.59|||||2-Sided|90.0|1.36|1.86|||||GMR is ratio of Experimental Group / Healthy Group||
1589364|NCT03259087|2922196|Other||Geometric Least Squares Mean Ratio (GMR)|1.21|||||2-Sided|90.0|1.04|1.4|||||GMR is ratio of Experimental Group / Healthy Group||
1589365|NCT03259087|2922197|Other||Geometric Least Squares Mean Ratio (GMR)|2.91|||||2-Sided|90.0|2.17|3.9|||||GMR is ratio of Experimental Group / Healthy Group||
1589366|NCT03259087|2922197|Other||Geometric Least Squares Mean Ratio (GMR)|1.68|||||2-Sided|90.0|1.41|1.99|||||GMR is ratio of Experimental Group / Healthy Group||
1589367|NCT03259087|2922197|Other||Geometric Least Squares Mean Ratio (GMR)|1.25|||||2-Sided|90.0|1.06|1.46|||||GMR is ratio of Experimental Group / Healthy Group||
1589368|NCT03259087|2922198|Other||Geometric Least Squares Mean Ratio (GMR)|2.98|||||2-Sided|90.0|2.2|4.04|||||GMR is ratio of Experimental Group / Healthy Group||
1589369|NCT03259087|2922198|Other||Geometric Least Squares Mean Ratio (GMR)|1.7|||||2-Sided|90.0|1.42|2.02|||||GMR is ratio of Experimental Group / Healthy Group||
1589370|NCT03259087|2922198|Other||Geometric Least Squares Mean Ratio (GMR)|1.25|||||2-Sided|90.0|1.07|1.47|||||GMR is ratio of Experimental Group / Healthy Group||
1589371|NCT03257995|2922294|Other||Mean Difference (Final Values)|30.8|||<|0.001|2-Sided|95.0|23.5|38.2|||ANOVA||||
1589372|NCT03257995|2922294|Other||Mean Difference (Final Values)|33.0|||<|0.001|2-Sided|95.0|25.6|40.3|||ANOVA||||
1589373|NCT03257995|2922295|Other||Mean Difference (Final Values)|-0.42||||0.008|2-Sided|95.0|-0.73|0.11|||ANOVA||||
1589374|NCT03257995|2922295|Other||Mean Difference (Final Values)|-0.42||||0.009|2-Sided|95.0|-0.73|0.11|||ANOVA||||
1589375|NCT03257995|2922296|Other||Mean Difference (Net)|-0.0028|||||2-Sided|95.0|-0.0647|0.059|||||||
1589376|NCT03257995|2922296|Other||Mean Difference (Final Values)|0.2448|||<|0.001|2-Sided|95.0|0.183|0.3066|||ANOVA||||
1589377|NCT03257995|2922296|Other||Mean Difference (Final Values)|0.2476|||<|0.001|2-Sided|95.0|0.1857|0.3095|||ANOVA||||
1589378|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.1997|||<|0.001|2-Sided|95.0|0.1023|0.297|||ANOVA|||23 hours 45 min|
1589379|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2044|||<|0.001|2-Sided|95.0|0.1071|0.3017|||ANOVA|||23 hours 15 min|
1589380|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.1987|||<|0.001|2-Sided|95.0|0.1036|0.2938|||ANOVA|||12 hours|
1589381|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2558|||<|0.001|2-Sided|95.0|0.1609|0.3506|||ANOVA|||8 hours|
1589382|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2661|||<|0.001|2-Sided|95.0|0.1715|0.3607|||ANOVA|||4 hours|
1589383|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2986|||<|0.001|2-Sided|95.0|0.2042|0.393|||ANOVA|||2 hours|
1589384|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2386|||<|0.001|2-Sided|95.0|0.1445|0.3328|||ANOVA|||1 hour|
1589385|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2723|||<|0.001|2-Sided|95.0|0.178|0.3667|||ANOVA|||30 min|
1589386|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2927|||<|0.001|2-Sided|95.0|0.1979|0.3875|||ANOVA|||15 min|
1589387|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.1956|||<|0.001|2-Sided|95.0|0.1012|0.2899|||ANOVA|||5 min|
1589388|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.1862|||<|0.001|2-Sided|95.0|0.0882|0.2842|||ANOVA|||23 hours 45 min|
1589389|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2453|||<|0.001|2-Sided|95.0|0.1473|0.3434|||ANOVA|||23 hours 15 min|
1589390|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2687|||<|0.001|2-Sided|95.0|0.1732|0.3643|||ANOVA|||12 hours|
1589391|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2538|||<|0.001|2-Sided|95.0|0.1585|0.3492|||ANOVA|||8 hours|
1589392|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.282|||<|0.001|2-Sided|95.0|0.1874|0.3766|||ANOVA|||4 hours|
1589699|NCT03239483|2922869|Superiority|||||||0.591|||||||Fisher Exact||||
1589396|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2923|||<|0.001|2-Sided|95.0|0.1979|0.3867|||ANOVA|||15 min|
1589397|NCT03257995|2922297|Other||Mean Difference (Final Values)|0.2025|||<|0.001|2-Sided|95.0|0.1059|0.2952|||ANOVA|||5 min|
1589398|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0266|||<|0.001|2-Sided|95.0|0.0152|0.0379|||ANOVA|||23 hour 45 min|
1589399|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0281|||<|0.001|2-Sided|95.0|0.0167|0.0394|||ANOVA|||23 hour 15 min|
1589400|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0285|||<|0.001|2-Sided|95.0|0.0175|0.0396|||ANOVA|||12 hour|
1589401|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0316|||<|0.001|2-Sided|95.0|0.0206|0.0426|||ANOVA|||8 hour|
1589402|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0278|||<|0.001|2-Sided|95.0|0.0168|0.0387|||ANOVA|||4 hour|
1589403|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0338|||<|0.001|2-Sided|95.0|0.0228|0.0447|||ANOVA|||2 hour|
1589404|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0278|||<|0.001|2-Sided|95.0|0.0169|0.0387|||ANOVA|||1 hour|
1589405|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.029|||<|0.001|2-Sided|95.0|0.018|0.0399|||ANOVA|||30 min|
1589406|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0344|||<|0.001|2-Sided|95.0|0.0234|0.0454|||ANOVA|||15 min|
1589407|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0222|||<|0.001|2-Sided|95.0|0.0113|0.0332|||ANOVA|||5 min|
1589408|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0301|||<|0.001|2-Sided|95.0|0.0187|0.0415|||ANOVA|||23 hour 45 min|
1589409|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0326|||<|0.001|2-Sided|95.0|0.0211|0.044|||ANOVA|||23 hour 15 min|
1589410|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0359|||<|0.001|2-Sided|95.0|0.0248|0.047|||ANOVA|||12 hour|
1589411|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0311|||<|0.001|2-Sided|95.0|0.02|0.0422|||ANOVA|||8 hour|
1589412|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0325|||<|0.001|2-Sided|95.0|0.0215|0.0435|||ANOVA|||4 hour|
1589413|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0338|||<|0.001|2-Sided|95.0|0.0228|0.0447|||ANOVA|||2 hour|
1589414|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0324|||<|0.001|2-Sided|95.0|0.0214|0.0434|||ANOVA|||1 hour|
1589415|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0306|||<|0.001|2-Sided|95.0|0.0197|0.0416|||ANOVA|||30 min|
1589416|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.033|||<|0.001|2-Sided|95.0|0.022|0.044|||ANOVA|||15 min|
1589417|NCT03257995|2922298|Other||Mean Difference (Final Values)|0.0249|||<|0.001|2-Sided|95.0|0.0139|0.0359|||ANOVA|||5 min|
1589418|NCT03257995|2922299|Other||Mean Difference (Final Values)|4.1|||<|0.001|2-Sided|95.0|2.1|6.1|||ANOVA|||23 hour 45 min|
1589419|NCT03257995|2922299|Other||Mean Difference (Final Values)|3.0|||<|0.004|2-Sided|95.0|1.0|5.0|||ANOVA|||23 hour 15 min|
1589420|NCT03257995|2922299|Other||Mean Difference (Final Values)|4.2|||<|0.001|2-Sided|95.0|2.2|6.2|||ANOVA|||12 hour|
1589421|NCT03257995|2922299|Other||Mean Difference (Final Values)|5.0|||<|0.001|2-Sided|95.0|3.0|7.0|||ANOVA|||8 hour|
1589422|NCT03257995|2922299|Other||Mean Difference (Final Values)|5.0|||<|0.001|2-Sided|95.0|3.1|7.0|||ANOVA|||4 hour|
1589423|NCT03257995|2922299|Other||Mean Difference (Final Values)|5.5|||<|0.001|2-Sided|95.0|3.5|7.4|||ANOVA|||2 hour|
1589424|NCT03257995|2922299|Other||Mean Difference (Final Values)|5.5|||<|0.001|2-Sided|95.0|3.5|7.5|||ANOVA|||1 hour|
1589425|NCT03257995|2922299|Other||Mean Difference (Final Values)|6.3|||<|0.001|2-Sided|95.0|4.4|8.3|||ANOVA|||30 min|
1589426|NCT03257995|2922299|Other||Mean Difference (Final Values)|5.8|||<|0.001|2-Sided|95.0|3.9|7.8|||ANOVA|||15 min|
1589427|NCT03257995|2922299|Other||Mean Difference (Final Values)|5.8|||<|0.001|2-Sided|95.0|3.9|7.8|||ANOVA|||5 min|
1589428|NCT03257995|2922299|Other||Mean Difference (Final Values)|4.1|||<|0.001|2-Sided|95.0|2.0|6.2|||ANOVA|||23 hour 45 min|
1589429|NCT03257995|2922299|Other||Mean Difference (Final Values)|4.6|||<|0.001|2-Sided|95.0|2.6|6.7|||ANOVA|||23 hour 15 min|
1589430|NCT03257995|2922299|Other||Mean Difference (Final Values)|4.5|||<|0.001|2-Sided|95.0|2.5|6.5|||ANOVA|||12 hour|
1589431|NCT03257995|2922299|Other||Mean Difference (Final Values)|5.0|||<|0.001|2-Sided|95.0|3.0|7.0|||ANOVA|||8 hour|
1589432|NCT03257995|2922299|Other||Mean Difference (Final Values)|4.3|||<|0.001|2-Sided|95.0|2.3|6.3|||ANOVA|||4 hour|
1589433|NCT03257995|2922299|Other||Mean Difference (Final Values)|4.7|||<|0.001|2-Sided|95.0|2.8|6.7|||ANOVA|||2 hour|
1589434|NCT03257995|2922299|Other||Mean Difference (Final Values)|5.5|||<|0.001|2-Sided|95.0|3.5|7.4|||ANOVA|||1 hour|
1589435|NCT03257995|2922299|Other||Mean Difference (Final Values)|6.6|||<|0.001|2-Sided|95.0|4.6|8.5|||ANOVA|||30 min|
1589436|NCT03257995|2922299|Other||Mean Difference (Final Values)|6.0|||<|0.001|2-Sided|95.0|4.0|7.9|||ANOVA|||15 min|
1589437|NCT03257995|2922299|Other||Mean Difference (Final Values)|5.0|||<|0.001|2-Sided|95.0|3.1|7.0|||ANOVA|||5 min|
1589438|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.1546|||<|0.001|2-Sided|95.0|0.0777|0.2315|||ANOVA|||23 hour 45 min|
1589439|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.1249|||<|0.001|2-Sided|95.0|0.048|0.2018|||ANOVA|||23 hour 15 min|
1589440|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.1619|||<|0.001|2-Sided|95.0|0.087|0.2369|||ANOVA|||12 hour|
1589441|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.1937|||<|0.001|2-Sided|95.0|0.119|0.2684|||ANOVA|||8 hours|
1589442|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.1946|||<|0.001|2-Sided|95.0|0.1201|0.2691|||ANOVA|||4 hours|
1589443|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.2005|||<|0.001|2-Sided|95.0|0.1262|0.2749|||ANOVA|||2 hours|
1589444|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.2013|||<|0.001|2-Sided|95.0|0.1272|0.2754|||ANOVA|||1 hour|
1589445|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.2375|||<|0.001|2-Sided|95.0|0.1632|0.3118|||ANOVA|||30 min|
1589446|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.2173|||<|0.001|2-Sided|95.0|0.1426|0.292|||ANOVA|||15 min|
1589447|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.213|||<|0.001|2-Sided|95.0|0.1386|0.2873|||ANOVA|||5 min|
1589448|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.1484|||<|0.001|2-Sided|95.0|0.0709|0.2259|||ANOVA|||23 hours 45 min|
1589449|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.1856|||<|0.001|2-Sided|95.0|0.1081|0.2631|||ANOVA|||23 hours 15 min|
1589450|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.1747|||<|0.001|2-Sided|95.0|0.0994|0.2501|||ANOVA|||12 hours|
1589451|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.199|||<|0.001|2-Sided|95.0|0.1239|0.2742|||ANOVA|||8 hours|
1589452|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.1621|||<|0.001|2-Sided|95.0|0.0876|0.2366|||ANOVA|||4 hours|
1589453|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.1802|||<|0.001|2-Sided|95.0|0.1059|0.2545|||ANOVA|||2 hours|
1589454|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.2074|||<|0.001|2-Sided|95.0|0.133|0.2817|||ANOVA|||1 hour|
1589455|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.2404|||<|0.001|2-Sided|95.0|0.1661|0.3148|||ANOVA|||30 min|
1589456|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.2249|||<|0.001|2-Sided|95.0|0.1506|0.2992|||ANOVA|||15 min|
1589457|NCT03257995|2922300|Other||Mean Difference (Final Values)|0.1866|||<|0.001|2-Sided|95.0|0.1121|0.2611|||ANOVA|||5 min|
1589458|NCT03257995|2922301|Other||Mean Difference (Final Values)|5.9|||<|0.001|2-Sided|95.0|3.7|8.0|||ANOVA|||at 23 hours 45 min|
1589459|NCT03257995|2922301|Other||Mean Difference (Final Values)|5.1|||<|0.001|2-Sided|95.0|2.9|7.2|||ANOVA|||at 23 hours 15 min|
1589460|NCT03257995|2922301|Other||Mean Difference (Final Values)|6.3|||<|0.001|2-Sided|95.0|4.2|8.4|||ANOVA|||at 12 hours|
1589461|NCT03257995|2922301|Other||Mean Difference (Final Values)|7.4|||<|0.001|2-Sided|95.0|5.3|9.5|||ANOVA|||at 8 hours|
1589462|NCT03257995|2922301|Other||Mean Difference (Final Values)|7.3|||<|0.001|2-Sided|95.0|5.2|9.4|||ANOVA|||at 4 hours|
1589463|NCT03257995|2922301|Other||Mean Difference (Final Values)|7.8|||<|0.001|2-Sided|95.0|5.7|9.9|||ANOVA|||at 2 hours|
1589464|NCT03257995|2922301|Other||Mean Difference (Final Values)|7.4|||<|0.001|2-Sided|95.0|5.3|9.4|||ANOVA|||at 1 hour|
1589465|NCT03257995|2922301|Other||Mean Difference (Final Values)|8.1|||<|0.001|2-Sided|95.0|6.0|10.2|||ANOVA|||at 30 min|
1589466|NCT03257995|2922301|Other||Mean Difference (Final Values)|8.3|||<|0.001|2-Sided|95.0|6.2|10.4|||ANOVA|||at 15 min|
1589467|NCT03257995|2922301|Other||Mean Difference (Final Values)|7.1|||<|0.001|2-Sided|95.0|5.0|9.2|||ANOVA|||at 5 min|
1589468|NCT03257995|2922301|Other||Mean Difference (Final Values)|6.4|||<|0.001|2-Sided|95.0|4.2|8.6|||ANOVA|||at 23 hours 45 min|
1589469|NCT03257995|2922301|Other||Mean Difference (Final Values)|7.0|||<|0.001|2-Sided|95.0|4.8|9.1|||ANOVA|||at 23 hours 15 min|
1589470|NCT03257995|2922301|Other||Mean Difference (Final Values)|7.6|||<|0.001|2-Sided|95.0|5.5|9.7|||ANOVA|||at 12 hours|
1589471|NCT03257995|2922301|Other||Mean Difference (Final Values)|7.3|||<|0.001|2-Sided|95.0|5.2|9.4|||ANOVA|||at 8 hours|
1589472|NCT03257995|2922301|Other||Mean Difference (Final Values)|7.1|||<|0.001|2-Sided|95.0|5.0|9.1|||ANOVA|||at 4 hours|
1589473|NCT03257995|2922301|Other||Mean Difference (Final Values)|7.6|||<|0.001|2-Sided|95.0|5.5|9.7|||ANOVA|||at 2 hours|
1589474|NCT03257995|2922301|Other||Mean Difference (Final Values)|8.0|||<|0.001|2-Sided|95.0|6.0|10.1|||ANOVA|||at 1 hour|
1589475|NCT03257995|2922301|Other||Mean Difference (Final Values)|8.6|||<|0.001|2-Sided|95.0|6.5|10.7|||ANOVA|||at 30|
1589476|NCT03257995|2922301|Other||Mean Difference (Final Values)|8.5|||<|0.001|2-Sided|95.0|6.4|10.6|||ANOVA|||at 15 min|
1589477|NCT03257995|2922301|Other||Mean Difference (Final Values)|7.1|||<|0.001|2-Sided|95.0|5.0|9.2|||ANOVA|||at 5 min|
1589478|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.1793|||<|0.001|2-Sided|95.0|0.108|0.2505|||ANOVA|||23 hour 45 min|
1589479|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.1625|||<|0.001|2-Sided|95.0|0.0912|0.2337|||ANOVA|||23 hour 15 min|
1589480|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2057|||<|0.001|2-Sided|95.0|0.1359|0.2755|||ANOVA|||12 hour|
1589481|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2324|||<|0.001|2-Sided|95.0|0.1627|0.302|||ANOVA|||8 hour|
1589482|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2322|||<|0.001|2-Sided|95.0|0.1627|0.3017|||ANOVA|||4 hour|
1589483|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2546|||<|0.001|2-Sided|95.0|0.1852|0.3239|||ANOVA|||2 hour|
1589484|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2348|||<|0.001|2-Sided|95.0|0.1656|0.304|||ANOVA|||1 hour|
1589485|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2572|||<|0.001|2-Sided|95.0|0.1879|0.3266|||ANOVA|||30 min|
1589486|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2684|||<|0.001|2-Sided|95.0|0.1988|0.338|||ANOVA|||15 min|
1589487|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2195|||<|0.001|2-Sided|95.0|0.1502|0.2889|||ANOVA|||5 min|
1589488|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.1954|||<|0.001|2-Sided|95.0|0.1237|0.2671|||ANOVA|||23 hour 45 min|
1589489|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.228|||<|0.001|2-Sided|95.0|0.1563|0.2997|||ANOVA|||23 hour 15 min|
1589490|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2443|||<|0.001|2-Sided|95.0|0.1742|0.3144|||ANOVA|||12 hour|
1589491|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2396|||<|0.001|2-Sided|95.0|0.1697|0.3096|||ANOVA|||8 hour|
1589492|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2273|||<|0.001|2-Sided|95.0|0.1578|0.2968|||ANOVA|||4 hour|
1591018|NCT03161938|2925188|Superiority|||||||0.154|||||||Chi-squared, Corrected|||day 1|
1589493|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2494|||<|0.001|2-Sided|95.0|0.18|0.3188|||ANOVA|||2 hour|
1589494|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2609|||<|0.001|2-Sided|95.0|0.1915|0.3302|||ANOVA|||1 hour|
1589495|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.273|||<|0.001|2-Sided|95.0|0.2036|0.3423|||ANOVA|||30 min|
1589496|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2724|||<|0.001|2-Sided|95.0|0.203|0.3417|||ANOVA|||15min|
1589497|NCT03257995|2922302|Other||Mean Difference (Final Values)|0.2177|||<|0.001|2-Sided|95.0|0.1482|0.2872|||ANOVA|||at 5 min|
1589498|NCT03257995|2922303|Other||Median Difference (Final Values)|0.0||||0.984|2-Sided|95.0|-0.5|0.73|||Wilcoxon (Mann-Whitney)||||
1589499|NCT03257995|2922303|Other||Median Difference (Final Values)|-0.02||||0.801|2-Sided|95.0|-0.82|0.51|||Wilcoxon (Mann-Whitney)||||
1589500|NCT03257995|2922303|Other||Median Difference (Final Values)|-0.02||||0.823|2-Sided|95.0|-0.83|0.33|||Wilcoxon (Mann-Whitney)||||
1589501|NCT03257995|2922309|Other||Mean Difference (Final Values)|-0.0398|||||2-Sided|95.0|-0.0942|0.0147|||||||
1589502|NCT03257995|2922309|Other||Mean Difference (Final Values)|0.1463|||<|0.001|2-Sided|95.0|0.0898|0.2029|||ANOVA||||
1589503|NCT03257995|2922309|Other||Mean Difference (Final Values)|0.1861|||<|0.001|2-Sided|95.0|0.1293|0.2429|||ANOVA||||
1589504|NCT03257865|2922311|Superiority||Treatment difference|-1.62|||=|0|2-Sided|95.0|-3.56|0.32|||mixed-effect model repeated measure||"Comparison between treatment groups was carried out using MMRM, with study center, treatment group, visit, and treatment group-by-visit interaction as factor and baseline-by-visit interaction as a covariate. An unstructured covariance was used."||
1589505|NCT03257813|2922312|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.765|||||||Chi-squared||||
1589506|NCT03257813|2922312|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||CrossOver|Chi-squared||||
1589507|NCT03257813|2922312|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.825||||||Baseline|Chi-squared||||
1589508|NCT03257813|2922313|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.793||||||Final Visit|Chi-squared||||
1589509|NCT03257813|2922313|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||CrossOver|Chi-squared||||
1589510|NCT03257813|2922313|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.023||||||Baseline|Chi-squared, Corrected||||
1589511|NCT03257813|2922314|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.534||||||Final Visit|Chi-squared||||
1589512|NCT03257813|2922314|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.391||||||Cross Over|Chi-squared||||
1589513|NCT03257813|2922314|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||1||||||baseline|Chi-squared||||
1589514|NCT03257813|2922315|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0||||||"Final Visit~No statistic will be calculated because Final Chemosis is a constant"|Chi-squared, Corrected||||
1589515|NCT03257813|2922315|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.497||||||CrossOver|Chi-squared, Corrected||||
1589516|NCT03257813|2922315|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.497||||||Baseline|Chi-squared, Corrected||||
1589517|NCT03257813|2922316|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.212||||||Final Visit|Fisher Exact||||
1589518|NCT03257813|2922316|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.148||||||CrossOver|Fisher Exact||||
1589519|NCT03257813|2922316|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.001||||||Baseline|Fisher Exact||||
1589520|NCT03257813|2922317|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 20% of the frequency.||||||0.085|||||||Chi-squared||||
1589521|NCT03257813|2922318|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.495||||||Final Visit|t-test, 2 sided||||
1589522|NCT03257813|2922318|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.507||||||CrossOver|t-test, 2 sided||||
1589523|NCT03257813|2922318|Non-Inferiority|to be considered as not inferior to the group, the differences between both should not be greater than 2 points on the snellen scale||||||0.823||||||Baseline|t-test, 2 sided||||
1589524|NCT03257813|2922319|Non-Inferiority|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.05||||||Final Visit|t-test, 2 sided||||
1589525|NCT03257813|2922319|Non-Inferiority|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.001||||||CrossOver|t-test, 2 sided||||
1589526|NCT03257813|2922319|Non-Inferiority|it will be considered not inferior if they keep the IOP goal with differences of no more than 1.5 mmHg||||||0.013||||||Baseline|t-test, 2 sided||||
1589527|NCT03257657|2922323|Other|||||||0.02|||||||t-test, 2 sided||||
1589528|NCT03257657|2922325|Other|||||||0.13|||||||t-test, 2 sided||||
1589529|NCT03257657|2922327|Other|||||||0.1|||||||t-test, 2 sided||||
1589530|NCT03256526|2922367|Superiority||LS mean difference|-18.73||||0.0395|2-Sided|90.0|-33.55|-3.9|||ANCOVA||||
1599051|NCT02858401|2938156|Other|||||||1|||||||Fisher Exact||||
1589531|NCT03256526|2922367|Superiority||LS mean difference|11.45||||0.1654|2-Sided|90.0|-2.19|25.09|||ANCOVA||||
1589532|NCT03255382|2922393|Other||Least Squares Mean Difference|-21.5|Standard Error of the Mean|3.66|<|0.001|2-Sided|95.0|-28.8|-14.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.|
1589533|NCT03255382|2922394|Other||Least Squares Mean Difference|-17.3|Standard Error of the Mean|3.75|<|0.001|2-Sided|95.0|-24.8|-9.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.|
1589534|NCT03255382|2922395|Other||Least Squares Mean Difference|-13.7|Standard Error of the Mean|2.7|<|0.001|2-Sided|95.0|-19.1|-8.4|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.|
1589535|NCT03255382|2922396|Other||Least Squares Mean Difference|-11.4|Standard Error of the Mean|2.64|<|0.001|2-Sided|95.0|-16.6|-6.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.|
1589536|NCT03255382|2922397|Other||Least Squares Mean Difference|16.8|Standard Error of the Mean|2.73|<|0.001|2-Sided|95.0|11.4|22.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589537|NCT03255382|2922398|Other||Least Squares Mean Difference|14.9|Standard Error of the Mean|2.8|<|0.001|2-Sided|95.0|9.4|20.5|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589538|NCT03255382|2922399|Other||Least Squares Mean Difference|0.059|Standard Error of the Mean|0.0186||0.002|2-Sided|95.0|0.022|0.096|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589539|NCT03255382|2922400|Other||Least Squares Mean Difference|0.087|Standard Error of the Mean|0.0215|<|0.001|2-Sided|95.0|0.045|0.13|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589540|NCT03255382|2922401|Other||Least Squares Mean Difference|-8.1|Standard Error of the Mean|1.53|<|0.001|2-Sided|95.0|-11.1|-5.0|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589541|NCT03255382|2922402|Other||Least Squares Mean Difference|-6.6|Standard Error of the Mean|1.23|<|0.001|2-Sided|95.0|-9.0|-4.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589542|NCT03255382|2922403|Other||Least Squares Mean Difference|-7.6|Standard Error of the Mean|1.06|<|0.001|2-Sided|95.0|-9.7|-5.5|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589543|NCT03255382|2922404|Other||Least Squares Mean Difference|-7.4|Standard Error of the Mean|1.15|<|0.001|2-Sided|95.0|-9.6|-5.1|||ANCOVA|||P-values were calculated using ANCOVA with prior phototherapy (yes/no), baseline value, and treatment in the model.|
1589544|NCT03255382|2922405|Other||Adjusted percentage difference|56.8|||<|0.001|2-Sided|95.0|42.7|70.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589545|NCT03255382|2922406|Other||Adjusted percentage difference|38.3|||<|0.001|2-Sided|95.0|23.6|53.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589546|NCT03255382|2922407|Other||Least Squares Mean Difference|-3.1|Standard Error of the Mean|0.65|<|0.001|2-Sided|95.0|-4.4|-1.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589547|NCT03255382|2922408|Other||Least Squares Mean Difference|-3.1|Standard Error of the Mean|0.61|<|0.001|2-Sided|95.0|-4.3|-1.9|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589548|NCT03255382|2922409|Other||Least Squares Mean Difference|-2.3|Standard Error of the Mean|0.59|<|0.001|2-Sided|95.0|-3.5|-1.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589549|NCT03255382|2922410|Other||Least Squares Mean Difference|-2.0|Standard Error of the Mean|0.57|<|0.001|2-Sided|95.0|-3.2|-0.9|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589550|NCT03255382|2922411|Other||Least Squares Mean Difference|-1.0|Standard Error of the Mean|0.13|<|0.001|2-Sided|95.0|-1.3|-0.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589551|NCT03255382|2922412|Other||Least Squares Mean Difference|-1.0|Standard Error of the Mean|0.13|<|0.001|2-Sided|95.0|-1.2|-0.7|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589552|NCT03255382|2922413|Other||Least Squares Mean Difference|7.85|Standard Error of the Mean|1.784|<|0.001|2-Sided|95.0|4.31|11.38|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589553|NCT03255382|2922414|Other||Least Squares Mean Difference|6.66|Standard Error of the Mean|1.787|<|0.001|2-Sided|95.0|3.11|10.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589554|NCT03255382|2922415|Other||Least Squares Mean Difference|4.63|Standard Error of the Mean|1.322|<|0.001|2-Sided|95.0|2.01|7.25|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589555|NCT03255382|2922416|Other||Least Squares Mean Difference|4.49|Standard Error of the Mean|1.385||0.002|2-Sided|95.0|1.74|7.23|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589556|NCT03255382|2922417|Other||Least Squares Mean Difference|-10.0|Standard Error of the Mean|1.47|<|0.001|2-Sided|95.0|-12.9|-7.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589557|NCT03255382|2922418|Other||Least Squares Mean Difference|-9.6|Standard Error of the Mean|1.39|<|0.001|2-Sided|95.0|-12.4|-6.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589700|NCT03239483|2922870|Superiority|||||||1||||||This is a calculated p-value. P-values of 1.0 are possible when using the Fisher Exact test method.|Fisher Exact||||
1589558|NCT03255382|2922419|Other||Least Squares Mean Difference|-9.8|Standard Error of the Mean|1.51|<|0.001|2-Sided|95.0|-12.8|-6.8|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589559|NCT03255382|2922420|Other||Least Squares Mean Difference|-10.2|Standard Error of the Mean|1.51|<|0.001|2-Sided|95.0|-13.2|-7.2|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589560|NCT03255382|2922421|Other||Least Squares Mean Difference|-9.3|Standard Error of the Mean|1.64|<|0.001|2-Sided|95.0|-12.6|-6.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589561|NCT03255382|2922422|Other||Least Squares Mean Difference|-4.8|Standard Error of the Mean|1.06|<|0.001|2-Sided|95.0|-6.9|-2.7|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589562|NCT03255382|2922423|Other||Least Squares Mean Difference|-0.3|Standard Error of the Mean|0.296||0.315|2-Sided|95.0|-0.88|0.29|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589563|NCT03255382|2922424|Other||Least Squares Mean Difference|-0.29|Standard Error of the Mean|0.307||0.352|2-Sided|95.0|-0.9|0.32|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589564|NCT03255382|2922425|Other||Least Squares Mean Difference|-3.0|Standard Error of the Mean|0.66|<|0.001|2-Sided|95.0|-4.3|-1.6|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589565|NCT03255382|2922426|Other||Least Squares Mean Difference|-2.3|Standard Error of the Mean|0.63|<|0.001|2-Sided|95.0|-3.6|-1.1|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589566|NCT03255382|2922427|Other||Least Squares Mean Difference|1.32|||<|0.001|2-Sided|95.0|0.936|1.704|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589567|NCT03255382|2922428|Other||Least Squares Mean Difference|1.146|||<|0.001|2-Sided|95.0|0.764|1.528|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589568|NCT03255382|2922429|Other||Least Squares Mean Difference|-3.9|Standard Error of the Mean|0.59|<|0.001|2-Sided|95.0|-5.1|-2.7|||van Elteren test|||P-values were calculated by stratified van Elteren test.|
1589569|NCT03255382|2922430|Other||Least Squares Mean Difference|-3.2|Standard Error of the Mean|0.63|<|0.001|2-Sided|95.0|-4.5|-2.0|||van Elteren test|||P-values were calculated by stratified van Elteren test.|
1589570|NCT03255382|2922431|Other||Adjusted percentage difference|38.3|||<|0.001|2-Sided|95.0|25.0|51.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589571|NCT03255382|2922432|Other||Adjusted percentage difference|19.8||||0.001|2-Sided|95.0|7.6|31.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589572|NCT03255382|2922433|Other||Adjusted percentage difference|46.4|||<|0.001|2-Sided|95.0|32.6|60.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589573|NCT03255382|2922434|Other||Adjusted percentage difference|41.3|||<|0.001|2-Sided|95.0|27.3|55.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589574|NCT03255382|2922435|Other||Adjusted percentage difference|33.0|||<|0.001|2-Sided|95.0|20.2|45.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589575|NCT03255382|2922436|Other||Adjusted percentage difference|18.3||||0.001|2-Sided|95.0|7.1|29.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589576|NCT03255382|2922437|Other||Adjusted percentage difference|8.4||||0.048|2-Sided|95.0|0.1|16.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589577|NCT03255382|2922438|Other||Adjusted percentage difference|1.7||||0.392|2-Sided|95.0|-2.1|5.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589578|NCT03255382|2922439|Other||Adjusted percentage difference|55.0|||<|0.001|2-Sided|95.0|41.2|68.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589579|NCT03255382|2922440|Other||Adjusted percentage difference|44.9|||<|0.001|2-Sided|95.0|30.8|59.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589580|NCT03255382|2922441|Other||Adjusted percentage difference|59.9|||<|0.001|2-Sided|95.0|46.3|73.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589581|NCT03255382|2922442|Other||Adjusted percentage difference|56.8|||<|0.001|2-Sided|95.0|42.7|70.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589582|NCT03255382|2922443|Other||Adjusted percentage difference|66.7|||<|0.001|2-Sided|95.0|53.4|80.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589583|NCT03255382|2922444|Other||Adjusted percentage difference|29.7|||<|0.001|2-Sided|95.0|17.1|42.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589584|NCT03255382|2922445|Other||Least Squares Mean Difference|-8.39|Standard Error of the Mean|1.175|<|0.001|2-Sided|95.0|-10.71|-6.06|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589585|NCT03255382|2922446|Other||Least Squares Mean Difference|-7.89|Standard Error of the Mean|1.101|<|0.001|2-Sided|95.0|-10.07|-5.71|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589586|NCT03255382|2922447|Other||Least Squares Mean Difference|-7.78|Standard Error of the Mean|0.958|<|0.001|2-Sided|95.0|-9.68|-5.88|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589587|NCT03255382|2922448|Other||Least Squares Mean Difference|-8.8|Standard Error of the Mean|0.972|<|0.001|2-Sided|95.0|-10.72|-6.87|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589588|NCT03255382|2922449|Other||Least Squares Mean Difference|-9.58|Standard Error of the Mean|0.936|<|0.001|2-Sided|95.0|-11.43|-7.72|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and treatment in the model.|
1589589|NCT03255382|2922450|Other||Least Squares Mean Difference|-7.19|Standard Error of the Mean|0.825|<|0.001|2-Sided|95.0|-8.82|-5.56|||ANCOVA|||P-values were calculated using ANCOVA with strata (phototherapy [yes/no]), baseline value, and the treatment in this model.|
1589590|NCT03255382|2922451|Other||Adjusted percentage difference|44.7|||<|0.001|2-Sided|95.0|30.9|58.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589591|NCT03255382|2922452|Other||Adjusted percentage difference|41.3|||<|0.001|2-Sided|95.0|27.3|55.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589592|NCT03255382|2922453|Other||Adjusted percentage difference|33.1|||<|0.001|2-Sided|95.0|20.7|45.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589593|NCT03255382|2922454|Other||Adjusted percentage difference|21.5|||<|0.001|2-Sided|95.0|10.4|32.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589594|NCT03255382|2922455|Other||Adjusted percentage difference|3.3||||0.323|2-Sided|95.0|-3.2|9.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589595|NCT03255382|2922456|Other||Adjusted percentage difference|0.0||||0.991|2-Sided|95.0|-2.0|2.1|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589596|NCT03255382|2922457|Other||Adjusted percentage difference|66.6|||<|0.001|2-Sided|95.0|53.3|79.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589597|NCT03255382|2922458|Other||Adjusted percentage difference|64.9|||<|0.001|2-Sided|95.0|51.5|78.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589598|NCT03255382|2922459|Other||Adjusted percentage difference|56.6|||<|0.001|2-Sided|95.0|43.2|70.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589599|NCT03255382|2922460|Other||Adjusted percentage difference|36.6|||<|0.001|2-Sided|95.0|23.8|49.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589600|NCT03255382|2922461|Other||Adjusted percentage difference|1.7||||0.392|2-Sided|95.0|-2.1|5.4|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589601|NCT03255382|2922462|Other||Adjusted percentage difference|64.8|||<|0.001|2-Sided|95.0|52.5|77.2|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589602|NCT03255382|2922463|Other||Adjusted percentage difference|56.5|||<|0.001|2-Sided|95.0|43.0|70.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589603|NCT03255382|2922464|Other||Adjusted percentage difference|66.6|||<|0.001|2-Sided|95.0|53.8|79.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589604|NCT03255382|2922465|Other||Adjusted percentage difference|66.6|||<|0.001|2-Sided|95.0|53.3|79.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589605|NCT03255382|2922466|Other||Adjusted percentage difference|66.6|||<|0.001|2-Sided|95.0|53.8|79.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589606|NCT03255382|2922467|Other||Adjusted percentage difference|9.9||||0.047|2-Sided|95.0|0.1|19.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589607|NCT03255382|2922468|Other||Adjusted percentage difference|46.4|||<|0.001|2-Sided|95.0|33.7|59.0|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589608|NCT03255382|2922469|Other||Adjusted percentage difference|36.3|||<|0.001|2-Sided|95.0|24.1|48.5|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589609|NCT03255382|2922470|Other||Adjusted percentage difference|39.6|||<|0.001|2-Sided|95.0|27.3|51.9|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589610|NCT03255382|2922471|Other||Adjusted percentage difference|53.1|||<|0.001|2-Sided|95.0|40.4|65.7|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589611|NCT03255382|2922472|Other||Adjusted percentage difference|63.4|||<|0.001|2-Sided|95.0|50.2|76.6|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589612|NCT03255382|2922473|Other||Adjusted percentage difference|46.8|||<|0.001|2-Sided|95.0|32.8|60.8|||Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test adjusted for strata (prior phototherapy [yes/no]).|
1589613|NCT03255382|2922474|Other||Adjusted percentage difference|73.3|||<|0.001|2-Sided|95.0|61.3|85.3|||Cochran-Mantel-Haenszel|||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (prior phototherapy [yes/no]).|
1589614|NCT03255291|2922475|Superiority|||||||0.1511||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.|
1589615|NCT03255291|2922476|Superiority|||||||0.0365||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise coping planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.|
1589616|NCT03255291|2922477|Superiority|||||||0.0711||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise action planning). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.|
1589617|NCT03255291|2922478|Superiority|||||||0.8661||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise imagery vividness). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.|
1589618|NCT03255291|2922479|Superiority|||||||0.1916||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise unpleasant feelings). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.|
1589619|NCT03255291|2922480|Superiority|||||||0.4673||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of the exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise affective attitudes). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichotomous mental imagery variable in this analysis.|
1589620|NCT03255291|2922481|Superiority|||||||0.8793||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise recovery self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.|
1589621|NCT03255291|2922482|Superiority|||||||0.007||||||Covariates: sex, race, age, education, risk display issue, health literacy, season, acceptability, self-reported health, adherence, baseline exercise|Mixed Models Analysis|||The secondary outcomes are hypothesized mediators of the effect of exercise-related mental imagery activities on future exercise behavior (e.g., exercise mental imagery will increase future exercise behavior by increasing exercise maintenance self-efficacy). Because these analyses are relevant only for the exercise condition, and the dichotomous mental imagery variable includes both exercise and sleep, it is not appropriate to include the dichtomous mental imagery variable in this analysis.|
1589622|NCT03255291|2922483|Superiority|||||||0.1397|||||||ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||This study was designed as a 3X2 factorial design & only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.|
1589623|NCT03255291|2922484|Superiority|||||||0.4946||||||-A Dunnett adjustment was used to adjust for multiple comparisons|ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||This study was designed as a 3X2 factorial design & only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.|
1589624|NCT03255291|2922485|Superiority|||||||0.0333||||||-A Dunnett adjustment was used to adjust for multiple comparisons|ANCOVA|Covariates were sex, race, age, education, numeracy, and graph literacy.||-This study was designed as a 3X2 factorial design and only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome. A Dunnett adjustment was used to adjust for multiple comparisons.|
1589625|NCT03255291|2922486|Superiority|-A Dunnett adjustment was used to adjust for multiple comparisons||||||0.0215|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||-The investigators tested whether weekly minutes of exercise was influenced by an interaction between risk display format and mental imagery behavior|
1589626|NCT03255291|2922486|Superiority|-A Dunnett adjustment was used to adjust for multiple comparisons||||||0.3329|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||-The investigators tested whether weekly minutes of exercise differed among the three risk display formats: risk ladder, table, and alphanumeric text.|
1589701|NCT03239483|2922875|Superiority|||||||0.072|||||||Fisher Exact|||two-sided Fisher's Exact Test|
1589902|NCT03233308|2923208|Other|||||||0.0003|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline)|
1589627|NCT03255291|2922486|Superiority|A Dunnett adjustment was used to adjust for multiple comparisons||||||0.0288|||||||ANCOVA|Covariates: sex, race, age, education, health literacy, season, risk display problem, acceptability, self-reported health, and baseline exercise.||The investigators tested whether weekly minutes of exercise at 90 day follow-up was higher in the exercise mental imagery condition than in the sleep mental imagery condition|
1589628|NCT03254134|2922533|Superiority||Hazard Ratio (HR)|0.549|||||2-Sided|95.0|0.303|0.994||||||There was no formal hypothesis testing.|The hazard ratio of systemic embolism for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable
1589629|NCT03254134|2922534|Superiority||Hazard Ratio (HR)|0.72|||||2-Sided|95.0|0.534|0.97||||||There was no formal hypothesis testing.|The hazard ratio of stroke for the dabigatran group as compared to the warfarin group and its 95% CI were estimated from the propensity score matched group using a Cox regression model with treatment group as the dependent variable
1589630|NCT03252015|2922550|Superiority||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|0.0|0.0||||||Day 21|
1589631|NCT03252015|2922550|Superiority||Mean Difference (Final Values)|0.071|||||2-Sided|95.0|-0.151|0.294||||||Day 21|
1589632|NCT03252015|2922550|Superiority||Mean Difference (Final Values)|0.071|||||2-Sided|95.0|-0.081|0.224|||||||
1589633|NCT03252015|2922550|Superiority||Mean Difference (Final Values)|-0.145|||||2-Sided|95.0|-0.34|0.05||||||Day 7|
1589634|NCT03252015|2922551|Superiority||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|0.0|0.0||||||Day 21|
1589635|NCT03252015|2922551|Superiority||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|0.0|0.0||||||Day 21|
1589636|NCT03252015|2922551|Superiority||Mean Difference (Final Values)|0.071|||||2-Sided|95.0|-0.081|0.224||||||Day 7|
1589637|NCT03252015|2922551|Superiority||Mean Difference (Final Values)|-0.182|||||2-Sided|95.0|-0.412|0.049||||||Day 7|
1589638|NCT03250845|2922572|Superiority|||||||0.03|||||||t-test, 1 sided|||H0: No difference in number of nursing actions per patient between Multigam 5% and Multigam 10% infusion Ha: Number of nursing actions per patient is smaller with Multigam 10% infusion|
1589639|NCT03250845|2922574|Superiority||||||<|0.0005|||||||t-test, 1 sided|||H0: No difference in hospitalisation time between Multigam 5% and Multigam 10% infusion Ha: Hospitalisation time with Multigam 10% infusion is significantly shorter than with Multigam 5%|
1589640|NCT03250845|2922575|Superiority||||||<|0.0001|||||||t-test, 1 sided|||H0: No difference between Multigam 5% and Multigam 10% infusion time Ha: Multigam 10% infusion time is significantly shorter than Multigam 5%|
1589641|NCT03249935|2922627|Superiority||Odds Ratio (OR)|0.68||||0.058|2-Sided|95.0|0.45|1.01|||Regression, Logistic|||Unadjusted odds ratio for Chlamydia viral load at baseline as a continuous variable in a logistic model predicting treatment failure at day 28.|
1589642|NCT03249935|2922627|Superiority||Odds Ratio (OR)|4.65||||0.197|2-Sided|95.0|0.45|47.89|||Regression, Logistic|||Unadjusted odds ratio for reporting at baseline new partners in the last 30 days (reference group=no new partners) from a logistic model predicting treatment failure at day 28.|
1589643|NCT03249935|2922627|Superiority||Odds Ratio (OR)|0.75||||0.656|2-Sided|95.0|0.22|2.62|||Regression, Logistic|||Unadjusted odds ratio for age in years as a continuous variable in a logistic regression model predicting treatment failure at day 28|
1589644|NCT03249935|2922628|Superiority|||||||||||||||||Assumptions were that 20% of enrolled chlamydia-infected males will have urethral symptoms and azithromycin treatment failures will occur in 10% of symptomatic men vs. 2% of asymptomatic men. At a one-sided 0.05 significance level with power of 0.80, a sample size of 357 evaluable males would be needed, or approximately 72 symptomatic and 285 asymptomatic males. Assuming 20% of males enrolled would be unevaluable, a total of 446 males was targeted for enrollment.|Given that the study closed early and there were only 4 treatment failures, formal hypothesis testing was not performed.
1589645|NCT03249779|2922629|Superiority|||||||0.133|||||||t-test, 2 sided||||
1589646|NCT03249779|2922630|Superiority|||||||0.0396|||||||t-test, 2 sided||||
1589647|NCT03248882|2922640|Superiority||Mean Difference (Net)|-41.8|||||2-Sided|80.0|-47.9|-35.0|||||||
1589648|NCT03248882|2922640|Superiority||Mean Difference (Net)|-25.0|||||2-Sided|80.0|-32.8|-16.1|||||||
1589649|NCT03248882|2922640|Superiority||Mean Difference (Net)|-21.0|||||2-Sided|80.0|-29.0|-12.2|||||||
1589650|NCT03248882|2922640|Superiority||Mean Difference (Net)|-4.4|||||2-Sided|80.0|-14.0|6.3|||||||
1589651|NCT03248882|2922641|Superiority||Mean Difference (Net)|-62.1|||||2-Sided|80.0|-66.0|-57.8|||||||
1589652|NCT03248882|2922641|Superiority||Mean Difference (Net)|-52.4|||||2-Sided|80.0|-57.2|-47.1|||||||
1589653|NCT03248882|2922641|Superiority||Mean Difference (Net)|-46.0|||||2-Sided|80.0|-51.3|-40.1|||||||
1589654|NCT03248882|2922641|Superiority||Mean Difference (Net)|-10.7|||||2-Sided|80.0|-19.4|-1.1|||||||
1589655|NCT03247985|2922653|Superiority|||||||0.02|||||||t-test, 2 sided|||A p-value of 0.05 was considered statistically significant.|
1589656|NCT03247985|2922656|Superiority|||||||0.09|||||||t-test, 2 sided|||Comparison between groups for unilateral operative time.|
1589657|NCT03247985|2922656|Superiority|||||||0.17|||||||t-test, 2 sided|||Comparison between groups for bilateral operative time.|
1589658|NCT03247738|2922662|Superiority|The primary end point of our study was the comparison of platelet reactivity measured by VerifyNow PRU between cangrelor and placebo at 30 minutes after drugs were administered at the start of PCI. Assuming a common standard deviation of 70 PRU, a sample size of 20 patients per group would allow detection of a 70 PRU difference between groups with 85% power and a two-sided α = 0.05. Considering the 2 arms and a possible 25% rate of invalid PD results we planned to randomize up to 50 patients.|Mean Difference (Net)|152.0|||<|0.001|2-Sided|95.0|108.0|195.0|||ANCOVA|the baseline value of platelet reactivity used as a covariate|||
1589659|NCT03246152|2922671|Other||||||>|0.05|||||||Pearson’s correlation coefficient|||Correlation between change in BCVA and the pre treatment, post treatment, and change in vascular density following 3-6 injections was performed.|
1589660|NCT03245762|2922674|Superiority||Odds Ratio (OR)|0.9||||0.93|2-Sided||||||Ordinal Categorical Analysis||||
1589903|NCT03233308|2923209|Other|||||||0.001|||||||t-test, 1 sided|||Mean Change from Baseline|
1591004|NCT03161938|2925187|Superiority|||||||0.954|||||||Chi-squared, Corrected|||Day 3, restlessness|
1589661|NCT03244865|2922755|Non-Inferiority|Non-inferiority will be verified if the RMSE between the two systems is within 7 BPM. A complete power analysis was not included as this is a pilot study.|||||<|0.1||||||Pilot Study|t-test, 2 sided|||There is only one ARM in the study. Standard monitoring and LaborView monitoring will be collected simultaneously and analyzed.|
1589662|NCT03244800|2922775|Superiority||Odds Ratio (OR)|10.76||||0.04|2-Sided|90.0|1.61|72.03|||Regression, Logistic||||
1589663|NCT03244800|2922776|Superiority|||||||0.002|||||||ANCOVA||||
1589664|NCT03244800|2922777|Superiority||||||<|0.001|||||||ANCOVA||||
1589665|NCT03244800|2922778|Superiority||||||<|0.001|||||||ANCOVA||||
1589666|NCT03244800|2922779|Superiority|||||||0.002|||||||ANCOVA||||
1589667|NCT03244800|2922780|Superiority||||||<|0.001|||||||ANCOVA||||
1589668|NCT03243084|2922788|Superiority|||||||0.0488||||||Threshold for significance is <.05.|Wilcoxon (Mann-Whitney)|||Investigators hypothesized that active stimulation would have a greater normalized pain change using a modulation index [(Pre-Post)/(Pre+Post)]|
1589669|NCT03243084|2922790|Superiority|||||||0.319||||||Threshold for significance is <.05.|ANOVA|||A 2x2 ANOVA was used to measure change in HF-HRV by condition (10 Hz vs sham) and session (first vs second) as within subjects variables|
1589670|NCT03240575|2922799|Superiority||Mean Difference (Net)|0.098|Standard Error of the Mean|0.029||0.001|2-Sided|95.0|0.04|0.156|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.|||
1589671|NCT03240575|2922800|Superiority||Mean Difference (Net)|0.005|Standard Error of the Mean|0.027||0.8593|2-Sided|95.0|-0.048|0.058|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.|||
1589672|NCT03240575|2922801|Superiority||Mean Difference (Net)|0.09|Standard Error of the Mean|0.027||0.0011|2-Sided|95.0|0.037|0.144|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.|||
1589673|NCT03240575|2922802|Superiority||Mean Difference (Net)|0.052|Standard Error of the Mean|0.027||0.0543|2-Sided|95.0|-0.001|0.105|||Mixed-effects model repeated measures|Treatment, visit and treatment by visit interaction as fixed effects, and baseline as well as baseline by visit interaction as covariates.|||
1589674|NCT03239873|2922803|Other||Difference in Percentage|2.9|||||2-Sided|95.0|-4.6|10.3|||||Miettinen and Nurminen||
1589675|NCT03239873|2922806|Other||Difference in Percentage|0.0|||||2-Sided|95.0|-1.3|1.3|||||Miettinen & Nurminen||
1589676|NCT03239873|2922807|Other||Difference in Percentage|0.0|||||2-Sided|95.0|-1.3|1.3|||||Miettinen & Nurminen||
1589677|NCT03239873|2922812|Other||Difference in Percentage|2.3|||||2-Sided|95.0|-4.7|9.2|||||Miettinen & Nurminen||
1589678|NCT03239873|2922813|Other||Difference in Percentage|1.9|||||2-Sided|95.0|-6.1|9.8|||||Miettinen & Nurminen||
1589679|NCT03239873|2922814|Other||Difference in Percentage|0.0|||||2-Sided|95.0|-2.5|2.6|||||Miettinen & Nurminen||
1589680|NCT03239873|2922815|Other||Difference in Percentage|1.6|||||2-Sided|95.0|-3.4|6.7|||||Miettinen & Nurminen||
1589681|NCT03239873|2922816|Other||Difference in Percentage|2.0||||0.415|2-Sided|95.0|-2.9|6.9|||Miettinen & Nurminen|||Injection site swelling|
1589682|NCT03239873|2922816|Other||Difference in Percentage|-1.6||||0.523|2-Sided|95.0|-6.6|3.4|||Miettinen & Nurminen|||Injection site pain|
1589683|NCT03239873|2922816|Other||Difference in Percentage|-0.3||||0.931|2-Sided|95.0|-6.9|6.4|||Miettinen & Nurminen|||Injection site erythema|
1589684|NCT03239873|2922817|Other||Difference in Percentage|-2.7||||0.111||95.0|-6.2|0.7|||Miettinen & Nurminen|||Injection site swelling|
1589685|NCT03239873|2922817|Other||Difference in Percentage|0.7||||0.796|2-Sided|95.0|-4.7|6.2|||Miettinen & Nurminen|||Injection site pain|
1589686|NCT03239873|2922817|Other||Difference of Percentage|-1.0||||0.696|2-Sided|95.0|-5.9|4.0|||Miettinen & Nurminen|||Injection site erythema|
1589687|NCT03239873|2922818|Other||Difference in Percentage|0.4||||0.312|2-Sided|95.0|-1.0|2.0|||Miettinen & Nurminen|||Zoster-like rash|
1589688|NCT03239873|2922818|Other||Difference in Percentage|-0.3||||0.576|2-Sided|95.0|-2.2|1.4|||Miettinen & Nurminen|||Varicella-like rash|
1589689|NCT03239873|2922818|Other||Difference in Percentage|1.1||||0.17|2-Sided|95.0|-0.7|3.4|||Miettinen & Nurminen|||Measles-like rash|
1589690|NCT03239873|2922819|Other||Difference in Percentage|-0.3||||0.318|2-Sided|95.0|-1.9|0.9|||Miettinen & Nurminen|||Zoster-like rash|
1589691|NCT03239873|2922819|Other||Difference in Percentage|1.3||||0.241||95.0|-1.0|4.0|||Miettinen & Nurminen|||Varicella-like rash|
1589692|NCT03239873|2922819|Other||Difference in Percentage|0.3||||0.317|2-Sided|95.0|-0.9|1.9|||Miettinen & Nurminen|||Rubella-like rash|
1589693|NCT03239873|2922819|Other||Difference in Percentage|-1.3||||0.102|2-Sided|95.0|-3.5|0.4|||Miettinen & Nurminen|||Measles-like rash|
1589694|NCT03239873|2922820|Other||Difference in Percentage|2.9||||0.204|2-Sided|95.0|-1.6|7.5|||Miettinen & Nurminen|||Up to 42 days after Vaccination 2|
1589695|NCT03239873|2922820|Other||Difference in Percentage|2.0||||0.436|2-Sided|95.0|-3.1|7.1|||Miettinen & Nurminen|||Up to 42 days after Vaccination 1|
1589696|NCT03239873|2922821|Non-Inferiority|The statistical criterion for noninferiority of the GMT corresponds to the lower bound of the 2-sided 95% CI on the GMT ratio [VARIVAX® PE34 process/VARIVAX® 2016 commercial product] being >0.67.|Risk Difference (RD)|1.0|||<|0.001|2-Sided|95.0|0.9|1.1|||Miettinen and Nurminen||||
1589697|NCT03239873|2922822|Other|Acceptability|Antibody Response Rate|98.4|||<|0.001|2-Sided|95.0|95.9|99.6|||Exact CI method/binomial proportion|||The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being >76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).|
1589698|NCT03239873|2922822|Non-Inferiority|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.|Risk Difference (RD)|0.0|||<|0.001|2-Sided|95.0|-2.7|2.8|||Miettinen and Nurminen||||
1589702|NCT03238911|2922884|Superiority||Risk Difference (RD)|-11.9||||0.005|2-Sided|95.0|-20.1|-3.6|||Cochran-Mantel-Haenszel|||The rate difference with 95% Newcombe confidence interval, adjusted for stratum using the Cochran-Mantel-Haenszel method, could not be estimated due to lack of events. Thus, the unadjusted treatment difference is presented together with 95% Wald-based confidence interval. The p-value is based on the Cochran-Mantel-Haenszel statistics.|
1589703|NCT03238911|2922885|Superiority||Mean Difference (Final Values)|-1.73||||0.3575|2-Sided|95.0|-5.44|1.98|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589704|NCT03238911|2922885|Superiority||Mean Difference (Final Values)|-1.63||||0.4778|2-Sided|95.0|-6.15|2.9|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589705|NCT03238911|2922885|Superiority||Mean Difference (Final Values)|-1.68||||0.373|2-Sided|95.0|-5.41|2.04|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589706|NCT03238911|2922885|Superiority||Mean Difference (Final Values)|-43.48|||<|0.0001|2-Sided|95.0|-54.92|-32.03|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589707|NCT03238911|2922885|Superiority||Mean Difference (Final Values)|6.61|||<|0.0089|2-Sided|95.0|1.69|11.53|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589708|NCT03238911|2922885|Superiority||Mean Difference (Final Values)|40.82|||<|0.0001|2-Sided|95.0|26.3|55.33|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589709|NCT03238911|2922886|Superiority||Mean Difference (Final Values)|-58.79||||0.0002|2-Sided|95.0|-88.75|-28.82|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589710|NCT03238911|2922886|Superiority||Mean Difference (Final Values)|-78.6||||0.001|2-Sided|95.0|-124.81|-32.39|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589711|NCT03238911|2922886|Superiority||Mean Difference (Final Values)|-207.33|||<|0.0001|2-Sided|95.0|-268.82|-145.84|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589712|NCT03238911|2922886|Superiority||Mean Difference (Final Values)|-71.02|||<|0.0459|2-Sided|95.0|-140.74|-1.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589713|NCT03238911|2922886|Superiority||Mean Difference (Final Values)|-18.28|||<|0.5601|2-Sided|95.0|-80.24|43.68|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589788|NCT03238352|2922916|Other||Diference of Least Square mean|43.67|Standard Error of the Mean|5.862|<|0.0001|2-Sided|95.0|32.001|55.334||P-value from Van Elteren test.|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Test Product versus Combined Control (Placebo and Negative Control) group is obtained by using estimates statement in the ANCOVA model|
1589714|NCT03238911|2922886|Superiority||Mean Difference (Final Values)|-14.84|||<|0.1922|2-Sided|95.0|-37.26|7.57|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589715|NCT03238911|2922887|Superiority||Mean Difference (Final Values)|0.42||||0.0185|2-Sided|95.0|0.07|0.76|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589716|NCT03238911|2922887|Superiority||Mean Difference (Final Values)|0.48||||0.0016|2-Sided|95.0|0.19|0.77|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589717|NCT03238911|2922887|Superiority||Mean Difference (Final Values)|0.4||||0.0257|2-Sided|95.0|0.05|0.74|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589718|NCT03238911|2922887|Superiority||Mean Difference (Final Values)|0.02||||0.858|2-Sided|95.0|-0.25|0.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589719|NCT03238911|2922887|Superiority||Mean Difference (Final Values)|-0.17||||0.366|2-Sided|95.0|-0.54|0.2|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589720|NCT03238911|2922887|Superiority||Mean Difference (Final Values)|-0.22||||0.4618|2-Sided|95.0|-0.82|0.37|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589721|NCT03238911|2922889|Superiority||Mean Difference (Final Values)|0.055||||0.1282|2-Sided|95.0|-0.016|0.126|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589722|NCT03238911|2922889|Superiority||Mean Difference (Final Values)|0.101||||0.0061|2-Sided|95.0|0.029|0.172|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589723|NCT03238911|2922889|Superiority||Mean Difference (Final Values)|0.101||||0.005|2-Sided|95.0|0.031|0.171|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589724|NCT03238911|2922889|Superiority||Mean Difference (Final Values)|0.064||||0.0472|2-Sided|95.0|0.001|0.127|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589725|NCT03238911|2922889|Superiority||Mean Difference (Final Values)|0.085||||0.004|2-Sided|95.0|0.028|0.142|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589789|NCT03238352|2922916|Other||Diference of Least Square mean|49.88|Standard Error of the Mean|7.079|<|0.0001|2-Sided|95.0|35.791|63.966||P-value from Van Elteren test|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.||
1591005|NCT03161938|2925187|Superiority|||||||0.531|||||||Chi-squared, Corrected|||Day 3, sadness|
1589726|NCT03238911|2922889|Superiority||Mean Difference (Final Values)|0.037||||0.267|2-Sided|95.0|-0.029|0.104|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589727|NCT03238911|2922890|Superiority||Mean Difference (Final Values)|-19.79||||0.0031|2-Sided|95.0|-32.75|-6.83|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589728|NCT03238911|2922890|Superiority||Mean Difference (Final Values)|-18.2||||0.0008|2-Sided|95.0|-28.68|-7.73|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589729|NCT03238911|2922890|Superiority||Mean Difference (Final Values)|-11.17||||0.0602|2-Sided|95.0|-22.84|0.49|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589730|NCT03238911|2922890|Superiority||Mean Difference (Final Values)|-0.49||||0.9242|2-Sided|95.0|-10.56|9.59|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589731|NCT03238911|2922890|Superiority||Mean Difference (Final Values)|-9.7||||0.0363|2-Sided|95.0|-18.78|-0.63|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589732|NCT03238911|2922890|Superiority||Mean Difference (Final Values)|-1.13||||0.7447|2-Sided|95.0|-7.96|5.71|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589733|NCT03238911|2922891|Superiority||Mean Difference (Final Values)|-0.59||||0.0014|2-Sided|95.0|-0.94|-0.23|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589734|NCT03238911|2922891|Superiority||Mean Difference (Final Values)|-0.64||||0.0006|2-Sided|95.0|-1.01|-0.28|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589735|NCT03238911|2922891|Superiority||Mean Difference (Final Values)|-0.8|||<|0.0001|2-Sided|95.0|-1.11|-0.49|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589736|NCT03238911|2922891|Superiority||Mean Difference (Final Values)|-0.51|||<|0.0008|2-Sided|95.0|-0.8|-0.21|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589737|NCT03238911|2922891|Superiority||Mean Difference (Final Values)|-0.37|||<|0.0023|2-Sided|95.0|-0.6|-0.13|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589790|NCT03238352|2922916|Other||Diference of Least Square mean|37.46|Standard Error of the Mean|7.306|<|0.0004|2-Sided|95.0|22.916|51.995||P-value from Van Elteren test|ANCOVA|From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline tactile threshold as a covariate.|Difference is the first named treatment minus second named treatment such that a positive difference favors the first named treatment.||
1599052|NCT02858401|2938156|Other|||||||1|||||||Fisher Exact||||
1589738|NCT03238911|2922891|Superiority||Mean Difference (Final Values)|-0.17|||<|0.0552|2-Sided|95.0|-0.34|0.0|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589739|NCT03238911|2922892|Superiority||Mean Difference (Final Values)|10.6||||0.0043|2-Sided|95.0|3.39|17.82|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589740|NCT03238911|2922892|Superiority||Mean Difference (Final Values)|22.87|||<|0.0001|2-Sided|95.0|14.79|30.95|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589741|NCT03238911|2922892|Superiority||Mean Difference (Final Values)|32.22|||<|0.0001|2-Sided|95.0|25.49|38.96|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589742|NCT03238911|2922892|Superiority||Mean Difference (Final Values)|20.14|||<|0.0001|2-Sided|95.0|12.07|28.22|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589743|NCT03238911|2922892|Superiority||Mean Difference (Final Values)|15.75|||<|0.0001|2-Sided|95.0|8.83|22.67|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589744|NCT03238911|2922892|Superiority||Mean Difference (Final Values)|24.27|||<|0.0001|2-Sided|95.0|18.81|29.73|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589745|NCT03238911|2922893|Superiority||Mean Difference (Final Values)|-0.22||||0.8287|2-Sided|95.0|-2.18|1.75|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589746|NCT03238911|2922893|Superiority||Mean Difference (Final Values)|1.17||||0.2368|2-Sided|95.0|-0.78|3.12|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589747|NCT03238911|2922893|Superiority||Mean Difference (Final Values)|2.09||||0.0379|2-Sided|95.0|0.12|4.05|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589748|NCT03238911|2922893|Superiority||Mean Difference (Final Values)|0.42||||0.608|2-Sided|95.0|-1.19|2.02|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589749|NCT03238911|2922893|Superiority||Mean Difference (Final Values)|1.75||||0.0126|2-Sided|95.0|0.38|3.12|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589884|NCT03233529|2923158|Superiority||Least Squares Mean Difference|-0.8|Standard Error of the Mean|0.36|<|0.0188|2-Sided|95.0|-1.6|-0.1|||Mixed Models Analysis||Comparison at Day 2|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1590150|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.08|||2-Sided|90.0|-0.2|0.1||||||Change at Week 12, Tandem Walk|
1589750|NCT03238911|2922893|Superiority||Mean Difference (Final Values)|-0.24||||0.562|2-Sided|95.0|-1.08|0.59|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589751|NCT03238911|2922894|Superiority||Mean Difference (Final Values)|-15.0||||0.1411|2-Sided|95.0|-35.04|5.06|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589752|NCT03238911|2922894|Superiority||Mean Difference (Final Values)|-48.4|||<|0.0001|2-Sided|95.0|-71.78|-24.96|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589753|NCT03238911|2922894|Superiority||Mean Difference (Final Values)|-100.7|||<|0.0001|2-Sided|95.0|-137.19|-64.2|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589754|NCT03238911|2922894|Superiority||Mean Difference (Final Values)|-191.3|||<|0.0001|2-Sided|95.0|-242.47|-140.09|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589755|NCT03238911|2922894|Superiority||Mean Difference (Final Values)|-49.3|||<|0.0001|2-Sided|95.0|-72.8|-25.9|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589756|NCT03238911|2922894|Superiority||Mean Difference (Final Values)|-99.1|||<|0.0001|2-Sided|95.0|-136.42|-61.76|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589757|NCT03238911|2922895|Superiority||Mean Difference (Final Values)|-37.16|||<|0.0001|2-Sided|95.0|-54.92|-19.39|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589758|NCT03238911|2922895|Superiority||Mean Difference (Final Values)|-71.21|||<|0.0001|2-Sided|95.0|-101.8|-40.61|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589759|NCT03238911|2922895|Superiority||Mean Difference (Final Values)|-117.47|||<|0.0001|2-Sided|95.0|-151.6|-83.33|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589760|NCT03238911|2922895|Superiority||Mean Difference (Final Values)|-293.23|||<|0.0001|2-Sided|95.0|-368.15|-218.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589761|NCT03238911|2922895|Superiority||Mean Difference (Final Values)|-60.76|||<|0.0001|2-Sided|95.0|-82.95|-38.58|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589885|NCT03233529|2923159|Superiority||Least Squares Mean Difference|-1.1|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.4|-0.8|||Mixed Models Analysis||Comparison at Day 15|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1591006|NCT03161938|2925187|Superiority|||||||0.11|||||||Chi-squared, Corrected|||day 2, fatigue|
1589762|NCT03238911|2922895|Superiority||Mean Difference (Final Values)|-105.74|||<|0.0001|2-Sided|95.0|-131.04|-80.45|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589763|NCT03238911|2922897|Superiority||Mean Difference (Final Values)|36.06|||<|0.0001|2-Sided|95.0|27.33|44.78|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589764|NCT03238911|2922897|Superiority||Mean Difference (Final Values)|32.28|||<|0.0001|2-Sided|95.0|23.09|41.48|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589765|NCT03238911|2922897|Superiority||Mean Difference (Final Values)|42.11|||<|0.0001|2-Sided|95.0|33.89|50.32|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589766|NCT03238911|2922897|Superiority||Mean Difference (Final Values)|32.78|||<|0.0001|2-Sided|95.0|25.71|39.84|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589767|NCT03238911|2922897|Superiority||Mean Difference (Final Values)|33.23|||<|0.0001|2-Sided|95.0|26.62|39.84|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589768|NCT03238911|2922897|Superiority||Mean Difference (Final Values)|15.55|||<|0.0001|2-Sided|95.0|10.32|20.79|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589769|NCT03238911|2922898|Superiority||Mean Difference (Final Values)|1.13|||<|0.0001|2-Sided|95.0|0.86|1.39|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589770|NCT03238911|2922898|Superiority||Mean Difference (Final Values)|1.03|||<|0.0001|2-Sided|95.0|0.75|1.32|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589771|NCT03238911|2922898|Superiority||Mean Difference (Final Values)|1.35|||<|0.0001|2-Sided|95.0|1.1|1.6|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589772|NCT03238911|2922898|Superiority||Mean Difference (Final Values)|1.03|||<|0.0001|2-Sided|95.0|0.81|1.25|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589773|NCT03238911|2922898|Superiority||Mean Difference (Final Values)|1.06|||<|0.0001|2-Sided|95.0|0.85|1.27|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589886|NCT03233529|2923159|Superiority||Least Square Mean Difference|-0.9|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.3|-0.6|||Mixed Models Analysis||Comparison at Day 8|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1591007|NCT03161938|2925187|Superiority|||||||0.064|||||||Chi-squared, Corrected|||Day 2, restlessness|
1589774|NCT03238911|2922898|Superiority||Mean Difference (Final Values)|0.48|||<|0.0001|2-Sided|95.0|0.31|0.65|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)-based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post-baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589775|NCT03238911|2922899|Superiority||Risk Difference (RD)|-39.2|||<|0.0001|2-Sided|95.0|-52.2|-23.3|||Cochran-Mantel-Haenszel|||Iron isomaltoside/ferric derisomaltose will be compared to ferric carboxymaltose by estimation of the risk difference and the associated 95 % CI, adjusting for strata (type of underlying disease (women with IDA due to gynaecological blood losses; yes/no) and screening s-phosphate level (< or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.|
1589776|NCT03238911|2922900|Superiority|||||||0.8979|||||||Log Rank|||The time with hypophosphatemia from baseline to day 35 was estimated by a Kaplan-Meier plot. The treatment groups were compared by a log-rank test. Only subjects who had one or more s-phosphate value(s) <2 mg/dL were included.|
1589777|NCT03238911|2922901|Superiority||Risk Difference (RD)|-67.0|||<|0.0001|2-Sided|95.0|-77.4|-51.5|||Cochran-Mantel-Haenszel||Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95% CI, adjusting for strata (underlying disease and screening s-phosphate) using the Cochran-Mantel-Haenszel method.|"Power:~The power was set to 80%. Assuming incidences of 15% for iron isomaltoside/ferric derisomaltose and 40% for ferric carboxymaltose, 49 subjects in each treatment group were required to detect a difference between the treatment groups. The significance level was set to 5%."|
1589778|NCT03238781|2922911|Superiority||difference in least square mean|0.56||||0.64|2-Sided|95.0|-1.77|2.89||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.|
1589779|NCT03238781|2922911|Superiority||difference in least square mean|-0.86||||0.46|2-Sided|95.0|-3.15|1.44||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.|
1589780|NCT03238781|2922912|Superiority||difference in least square mean|0.31||||0.79|2-Sided|95.0|-2.01|2.63||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.|
1589781|NCT03238781|2922912|Superiority||difference in least square mean|-0.28||||0.81|2-Sided|95.0|-2.56|2.01||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.|
1589782|NCT03238781|2922913|Superiority||difference in least square mean|-0.09||||0.84|2-Sided|95.0|-0.94|0.77||2-sided significance level of 0.05|Mixed Models Analysis||||
1589783|NCT03238781|2922913|Superiority||difference in least square mean|-0.03||||0.94|2-Sided|95.0|-0.87|0.81||2-sided significance level of 0.05|Mixed Models Analysis|||Adjusted analysis utilizes a generalized linear mixed model which includes treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (CM versus EM), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.|
1589784|NCT03238781|2922914|Superiority||Odds Ratio (OR)|0.76||||0.45|2-Sided|95.0|0.37|1.54||2-sided significance level of 0.05|Cochran-Mantel-Haenszel|||The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).|
1589785|NCT03238781|2922914|Superiority||Odds Ratio (OR)|0.82||||0.57|2-Sided|95.0|0.41|1.62||2-sided significance level of 0.05|Cochran-Mantel-Haenszel|||The common odds ratios and p-values are obtained from a Cochran-Mantel-Haenszel test, stratified by stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine).|
1589786|NCT03238781|2922915|Superiority||difference in least square mean|0.27||||0.65|2-Sided|95.0|-0.89|1.43||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.|
1589787|NCT03238781|2922915|Superiority||difference in least square mean|0.26||||0.66|2-Sided|95.0|-0.88|1.4||2-sided significance level of 0.05|Mixed Models Analysis|||An adjusted analysis is presented that utilized a generalized linear mixed model which included treatment, visit, treatment-by-visit interaction, stratification factors of region and baseline migraine frequency (chronic migraine vs episodic migraine), and baseline value as covariates and assuming a first-order autoregressive covariance structure. The p-values for pairwise comparisons versus placebo are nominal p-values without multiplicity adjustment.|
1589887|NCT03233529|2923160|Superiority||Least Squares Mean Difference|-2.1|Standard Error of the Mean|0.33|<|0.0001|2-Sided|95.0|-2.7|-1.4|||Mixed Models Analysis|||Crisaborole 2% was superior to vehicle if p-value was <0.05.|
1589791|NCT03238352|2922917|Other||Difference of Least Square mean|-1.25|Standard Error of the Mean|0.176|<|0.0001|2-Sided|95.0|-1.6|-0.901|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Test Product versus Combined Control (Placebo and Negative Control) group was obtained by using estimates statement in the ANCOVA model.|
1589792|NCT03238352|2922917|Other||Difference of Least Square mean|-1.28|Standard Error of the Mean|0.213|<|0.0001|2-Sided|95.0|-1.705|-0.858|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1589793|NCT03238352|2922917|Other||Difference of Least Square mean|-1.22|Standard Error of the Mean|0.22|<|0.0001|2-Sided|95.0|-1.657|-0.782|||ANCOVA|From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Test Product versus Negative Control at Week 8 is a primary endpoint comparison.|
1589794|NCT03238001|2922928|Non-Inferiority|In order to show non-inferiority, a lower 90% confidence limit (CL) for the difference in kappa scores would need to be greater than or equal to -0.20. The 90% confidence interval was calculated based on 5000 bootstrapped differences in kappa scores.|Lower 90% CL for difference in Kappas|-0.12|||||2-Sided|90.0|-0.12|0.05|||||90% CI for Kappa of DCTclock/MoCA - Kappa of MMSE/MoCA (estimated with bootstrap method using 5000 bootstraps).|A two-one-sided tests approach was taken, where, prior to analysis, it was determined that a delta (equivalence margin) of 0.20 would be considered a significant difference between the DCTclock/MoCA kappa and the MMSE/MoCA kappa. The reasoning behind this determination can be found in the study's statistical analysis plan.|
1589795|NCT03237065|2922957|Superiority||Risk Difference (RD)|-10.7||||0.009|2-Sided|95.0|-18.8|-2.6|||Cochran-Mantel-Haenszel|||The rate difference with 95% Newcombe confidence interval, adjusted for stratum using the Cochran-Mantel-Haenszel method, could not be estimated due to lack of events. Thus, the unadjusted treatment difference is presented together with 95% Wald-based confidence interval. The p-value is based on the Cochran-Mantel-Haenszel statistics.|
1589796|NCT03237065|2922958|Superiority||Mean Difference (Final Values)|-4.8||||0.004|2-Sided|95.0|-8.1|-1.6|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589797|NCT03237065|2922958|Superiority||Mean Difference (Final Values)|-5.8||||0.0008|2-Sided|95.0|-9.1|-2.4|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589798|NCT03237065|2922958|Superiority||Mean Difference (Final Values)|-6.9||||0.0001|2-Sided|95.0|-10.4|-3.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589799|NCT03237065|2922958|Superiority||Mean Difference (Final Values)|-62.2|||<|0.0001|2-Sided|95.0|-70.1|-54.3|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589800|NCT03237065|2922958|Superiority||Mean Difference (Final Values)|2.2|||<|0.5794|2-Sided|95.0|-5.5|9.8|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589801|NCT03237065|2922958|Superiority||Mean Difference (Final Values)|24.2|||<|0.0503|2-Sided|95.0|0.0|48.5|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589802|NCT03237065|2922959|Superiority||Mean Difference (Final Values)|-67.7||||0.0039|2-Sided|95.0|-113.2|-22.2|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589803|NCT03237065|2922959|Superiority||Mean Difference (Final Values)|-135.1|||<|0.0001|2-Sided|95.0|-196.1|-74.0|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589888|NCT03233529|2923167|Superiority||Least Squares Mean Difference|-1.9913|Standard Error of the Mean|0.68659||0.0042|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589804|NCT03237065|2922959|Superiority||Mean Difference (Final Values)|-240.4|||<|0.0001|2-Sided|95.0|-318.4|-162.3|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589805|NCT03237065|2922959|Superiority||Mean Difference (Final Values)|-91.7|||<|0.0113|2-Sided|95.0|-162.3|-21.1|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589806|NCT03237065|2922959|Superiority||Mean Difference (Final Values)|-24.2|||<|0.4929|2-Sided|95.0|-94.0|45.5|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589807|NCT03237065|2922959|Superiority||Mean Difference (Final Values)|-6.5|||<|0.6568|2-Sided|95.0|-35.3|22.3|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589808|NCT03237065|2922960|Superiority||Mean Difference (Final Values)|0.3||||0.0882|2-Sided|95.0|-0.05|0.64|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589809|NCT03237065|2922960|Superiority||Mean Difference (Final Values)|0.28||||0.0492|2-Sided|95.0|0.0|0.55|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589810|NCT03237065|2922960|Superiority||Mean Difference (Final Values)|0.46||||0.0056|2-Sided|95.0|0.14|0.79|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589811|NCT03237065|2922960|Superiority||Mean Difference (Final Values)|0.32||||0.0628|2-Sided|95.0|-0.02|0.66|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589812|NCT03237065|2922960|Superiority||Mean Difference (Final Values)|-0.34||||0.0941|2-Sided|95.0|-0.74|0.06|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589813|NCT03237065|2922960|Superiority||Mean Difference (Final Values)|-0.31||||0.0882|2-Sided|95.0|-0.67|0.05|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589814|NCT03237065|2922962|Superiority||Mean Difference (Final Values)|0.05||||0.2376|2-Sided|95.0|-0.03|0.12|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589815|NCT03237065|2922962|Superiority||Mean Difference (Final Values)|0.07||||0.0408|2-Sided|95.0|0.0|0.14|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589889|NCT03233529|2923168|Superiority||Least Squares Mean Difference|-1.1246|Standard Error of the Mean|0.49359||0.0238|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589890|NCT03233529|2923169|Superiority||Least Squares Mean Difference|-1.3641|Standard Error of the Mean|0.48603||0.0055|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589816|NCT03237065|2922962|Superiority||Mean Difference (Final Values)|-0.01||||0.9385|2-Sided|95.0|-0.17|0.16|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589817|NCT03237065|2922962|Superiority||Mean Difference (Final Values)|0.05||||0.1333|2-Sided|95.0|-0.02|0.12|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589818|NCT03237065|2922962|Superiority||Mean Difference (Final Values)|0.05||||0.1641|2-Sided|95.0|-0.02|0.13|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589819|NCT03237065|2922962|Superiority||Mean Difference (Final Values)|-0.03||||0.3048|2-Sided|95.0|-0.1|0.03|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589820|NCT03237065|2922963|Superiority||Mean Difference (Final Values)|-24.81|||<|0.0001|2-Sided|95.0|-35.42|-14.21|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589821|NCT03237065|2922963|Superiority||Mean Difference (Final Values)|-22.54|||<|0.0002|2-Sided|95.0|-33.93|-11.16|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589822|NCT03237065|2922963|Superiority||Mean Difference (Final Values)|-15.69|||<|0.0034|2-Sided|95.0|-26.07|-5.32|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589823|NCT03237065|2922963|Superiority||Mean Difference (Final Values)|0.4|||<|0.9221|2-Sided|95.0|-7.75|8.56|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589824|NCT03237065|2922963|Superiority||Mean Difference (Final Values)|-4.64|||<|0.2997|2-Sided|95.0|-13.47|4.19|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589825|NCT03237065|2922963|Superiority||Mean Difference (Final Values)|4.57|||<|0.2166|2-Sided|95.0|-2.72|11.85|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589826|NCT03237065|2922964|Superiority||Mean Difference (Final Values)|-0.23||||0.1063|2-Sided|95.0|-0.5|0.05|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589827|NCT03237065|2922964|Superiority||Mean Difference (Final Values)|-0.5||||0.0003|2-Sided|95.0|-0.77|-0.24|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589891|NCT03233529|2923170|Superiority||Least Squares Mean Difference|-0.7612|Standard Error of the Mean|0.44266||0.0871|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589892|NCT03233529|2923171|Superiority||Least Squares Mean Difference|-1.1273|Standard Error of the Mean|0.32552||0.0007|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589828|NCT03237065|2922964|Superiority||Mean Difference (Final Values)|-0.47||||0.0018|2-Sided|95.0|-0.76|-0.18|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589829|NCT03237065|2922964|Superiority||Mean Difference (Final Values)|-0.14||||0.3169|2-Sided|95.0|-0.41|0.14|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589830|NCT03237065|2922964|Superiority||Mean Difference (Final Values)|0.04||||0.7579|2-Sided|95.0|-0.24|0.32|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589831|NCT03237065|2922964|Superiority||Mean Difference (Final Values)|-0.06||||0.5134|2-Sided|95.0|-0.22|0.11|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589832|NCT03237065|2922965|Superiority||Mean Difference (Final Values)|9.03||||0.025|2-Sided|95.0|1.16|16.9|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589833|NCT03237065|2922965|Superiority||Mean Difference (Final Values)|21.82|||<|0.0001|2-Sided|95.0|14.2|29.43|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589834|NCT03237065|2922965|Superiority||Mean Difference (Final Values)|33.05|||<|0.0001|2-Sided|95.0|25.96|40.14|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589835|NCT03237065|2922965|Superiority||Mean Difference (Final Values)|19.56|||<|0.0001|2-Sided|95.0|12.37|26.74|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589836|NCT03237065|2922965|Superiority||Mean Difference (Final Values)|4.64|||<|0.2923|2-Sided|95.0|-4.05|13.33|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589837|NCT03237065|2922965|Superiority||Mean Difference (Final Values)|21.81|||<|0.0001|2-Sided|95.0|17.66|25.95|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589838|NCT03237065|2922966|Superiority||Mean Difference (Final Values)|0.14||||0.8878|2-Sided|95.0|-1.77|2.04|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589839|NCT03237065|2922966|Superiority||Mean Difference (Final Values)|-1.37||||0.0999|2-Sided|95.0|-3.01|0.27|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589893|NCT03233529|2923172|Superiority||Least Squares Mean Difference|-0.5446|Standard Error of the Mean|0.37855||0.1519|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589894|NCT03233529|2923173|Superiority||Least Squares Mean Difference|-0.9906|Standard Error of the Mean|0.48404||0.042|||||||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589840|NCT03237065|2922966|Superiority||Mean Difference (Final Values)|-1.91||||0.0176|2-Sided|95.0|-3.47|-0.34|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589841|NCT03237065|2922966|Superiority||Mean Difference (Final Values)|-1.62||||0.0213|2-Sided|95.0|-2.99|-0.25|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589842|NCT03237065|2922966|Superiority||Mean Difference (Final Values)|-1.04||||0.1037|2-Sided|95.0|-2.29|0.22|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589843|NCT03237065|2922966|Superiority||Mean Difference (Final Values)|-0.18||||0.6869|2-Sided|95.0|-1.06|0.7|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589844|NCT03237065|2922967|Superiority||Mean Difference (Final Values)|11.3||||0.4379|2-Sided|95.0|-18.6|41.2|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589845|NCT03237065|2922967|Superiority||Mean Difference (Final Values)|-24.3||||0.1988|2-Sided|95.0|-62.3|13.7|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589846|NCT03237065|2922967|Superiority||Mean Difference (Final Values)|-27.3||||0.3516|2-Sided|95.0|-86.0|31.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589847|NCT03237065|2922967|Superiority||Mean Difference (Final Values)|-155.7||||0.0005|2-Sided|95.0|-234.7|-76.6|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589848|NCT03237065|2922967|Superiority||Mean Difference (Final Values)|20.7||||0.5547|2-Sided|95.0|-49.7|91.0|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589849|NCT03237065|2922967|Superiority||Mean Difference (Final Values)|-57.5||||0.1243|2-Sided|95.0|-131.1|16.1|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589850|NCT03237065|2922968|Superiority||Mean Difference (Final Values)|-18.0||||0.0039|2-Sided|95.0|-30.1|-5.9|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589851|NCT03237065|2922968|Superiority||Mean Difference (Final Values)|-61.8|||<|0.0001|2-Sided|95.0|-83.0|-40.5|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589895|NCT03233529|2923174|Superiority||Least Squares Mean Difference|-2.4|Standard Error of the Mean|0.35|<|0.0001|2-Sided|95.0|-3.1|-1.7|||Mixed Models Analysis|||Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589896|NCT03233438|2923204|Superiority||Mean Difference (Final Values)|1.7|Standard Deviation|2.56||0.003|2-Sided|95.0|0.6|2.8|||t-test, 2 sided||||
1589852|NCT03237065|2922968|Superiority||Mean Difference (Final Values)|-79.1|||<|0.0001|2-Sided|95.0|-103.7|-54.5|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589853|NCT03237065|2922968|Superiority||Mean Difference (Final Values)|-251.7|||<|0.0001|2-Sided|95.0|-307.2|-196.2|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589854|NCT03237065|2922968|Superiority||Mean Difference (Final Values)|-15.7|||<|0.1064|2-Sided|95.0|-34.9|3.4|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589855|NCT03237065|2922968|Superiority||Mean Difference (Final Values)|-96.8|||<|0.0001|2-Sided|95.0|-119.8|-73.8|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589856|NCT03237065|2922970|Superiority||Mean Difference (Final Values)|34.53|||<|0.0001|2-Sided|95.0|26.8|42.26|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589857|NCT03237065|2922970|Superiority||Mean Difference (Final Values)|37.86|||<|0.0001|2-Sided|95.0|29.99|45.72|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589858|NCT03237065|2922970|Superiority||Mean Difference (Final Values)|36.17|||<|0.0001|2-Sided|95.0|29.28|43.06|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589859|NCT03237065|2922970|Superiority||Mean Difference (Final Values)|21.66|||<|0.0001|2-Sided|95.0|14.72|28.59|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589860|NCT03237065|2922970|Superiority||Mean Difference (Final Values)|15.84|||<|0.0001|2-Sided|95.0|9.45|22.23|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589861|NCT03237065|2922970|Superiority||Mean Difference (Final Values)|13.99|||<|0.0001|2-Sided|95.0|9.38|18.59|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589862|NCT03237065|2922971|Superiority||Mean Difference (Final Values)|1.17|||<|0.0001|2-Sided|95.0|0.91|1.43|||Mixed model for repeated measures|||"Day 35~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589863|NCT03237065|2922971|Superiority||Mean Difference (Final Values)|1.24|||<|0.0001|2-Sided|95.0|0.98|1.51|||Mixed model for repeated measures|||"Day 21~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589897|NCT03233438|2923205|Superiority||Mean Difference (Final Values)|1.6|Standard Deviation|2.5||0.003|2-Sided|95.0|0.6|2.6|||t-test, 2 sided||||
1589898|NCT03233308|2923206|Other||||||<|0.0001|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline)- IOP|
1589864|NCT03237065|2922971|Superiority||Mean Difference (Final Values)|1.22|||<|0.0001|2-Sided|95.0|0.99|1.46|||Mixed model for repeated measures|||"Day 14~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589865|NCT03237065|2922971|Superiority||Mean Difference (Final Values)|0.73|||<|0.0001|2-Sided|95.0|0.49|0.96|||Mixed model for repeated measures|||"Day 8~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589866|NCT03237065|2922971|Superiority||Mean Difference (Final Values)|0.54|||<|0.0001|2-Sided|95.0|0.32|0.76|||Mixed model for repeated measures|||"Day 7~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589867|NCT03237065|2922971|Superiority||Mean Difference (Final Values)|0.46|||<|0.0001|2-Sided|95.0|0.3|0.62|||Mixed model for repeated measures|||"Day 1~Change from baseline was analysed using a Restricted Maximum Likelihood (REML)- based Mixed Model for Repeated Measures (MMRM) approach. All subjects with post baseline data were included with their observed data.~The model included the fixed, categorical effects of treatment, strata, day, treatment-by-day interaction, as well as the continuous, fixed covariates of the parameters baseline value, and baseline value-by-day interaction."|
1589868|NCT03237065|2922972|Superiority||Risk Difference (RD)|-44.6|||<|0.0001|2-Sided|95.0|-57.7|-31.6|||Cochran-Mantel-Haenszel|||Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95 % CI, adjusting for strata (type of underlying disease (women with IDA due to gynaecological blood losses; yes/no) and screening s-phosphate level (< or ≥ 3.5 mg/dL)) using the Cochran-Mantel-Haenszel method.|
1589869|NCT03237065|2922973|Superiority|||||||0.0511|||||||Log Rank|||The time with hypophosphatemia from baseline to day 35 was estimated by a Kaplan- Meier plot. The treatment groups were compared by a log-rank test. Only subjects who had one or more s-phosphate value(s) <2 mg/dL were included.|
1589870|NCT03237065|2922974|Superiority||Risk Difference (RD)|-65.8|||<|0.0001|2-Sided|95.0|-76.6|-49.8|||Cochran-Mantel-Haenszel|Rate difference with 95% Newcombe confidence intervals (CI) adjusted for stratum, using the Cochran-Mantel-Haenszel method.|Iron isomaltoside/ferric derisomaltose was compared to ferric carboxymaltose by estimation of the risk difference and the associated 95% CI, adjusting for strata (underlying disease and screening s-phosphate) using the Cochran-Mantel-Haenszel method.|"Power:~The power was set to 80%. Assuming incidences of 15% for iron isomaltoside/ferric derisomaltose and 40% for ferric carboxymaltose, 49 subjects in each treatment group were required to detect a difference between the treatment groups. The significance level was set to 5%."|
1589871|NCT03233529|2923158|Superiority||Least-Square Mean of Difference|-1.9|Standard Error of the Mean|0.36|<|0.0001|2-Sided|95.0|-2.7|-1.2|||Mixed Models Analysis||Comparison at Day 15|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589872|NCT03233529|2923158|Superiority||Least-Square Mean of Difference|-1.7|Standard Error of the Mean|0.36|<|0.0001|2-Sided|95.0|-2.4|-1.0|||Mixed Models Analysis||Comparison at Day 14|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589873|NCT03233529|2923158|Superiority||Least-Square Mean of Difference|-1.9|Standard Error of the Mean|0.36|<|0.0001|2-Sided|95.0|-2.6|-1.2|||Mixed Models Analysis||Comparison at Day 13|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589874|NCT03233529|2923158|Superiority||Least-Square Mean of Difference|-2.2|Standard Error of the Mean|0.36|<|0.0001|2-Sided|95.0|-2.9|-1.5|||Mixed Models Analysis||Comparison at Day 12|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589875|NCT03233529|2923158|Superiority||Least-Square Mean of Difference|-1.6|Standard Error of the Mean|0.37|<|0.0001|2-Sided|95.0|-2.3|-0.9|||Mixed Models Analysis||Comparison at Day 11|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589876|NCT03233529|2923158|Superiority||Least-Square Mean of Difference|-2.0|Standard Error of the Mean|0.36|<|0.0001|2-Sided|95.0|-2.7|-1.3|||Mixed Models Analysis||Comparison at Day 10|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589877|NCT03233529|2923158|Superiority||Least-Square Mean of Difference|-1.9|Standard Error of the Mean|0.36|<|0.0001|2-Sided|95.0|-2.6|-1.2|||Mixed Models Analysis||Comparison at Day 9|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589878|NCT03233529|2923158|Superiority||Least-Square Mean of Difference|-1.8|Standard Error of the Mean|0.36|<|0.0001|2-Sided|95.0|-2.5|-1.1|||Mixed Models Analysis||Comparison at Day 8|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589879|NCT03233529|2923158|Superiority||Least-Square Mean of Difference|-1.5|Standard Error of the Mean|0.36|<|0.0001|2-Sided|95.0|-2.3|-0.8|||Mixed Models Analysis||Comparison at Day 7|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589880|NCT03233529|2923158|Superiority||Least-Square Mean of Difference|-1.3|Standard Error of the Mean|0.36|<|0.0003|2-Sided|95.0|-2.0|-0.6|||Mixed Models Analysis||Comparison at Day 6|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589881|NCT03233529|2923158|Superiority||Least-Square Mean of Difference|-1.5|Standard Error of the Mean|0.36|<|0.0001|2-Sided|95.0|-2.2|-0.8|||Mixed Models Analysis||Comparison at Day 5|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589882|NCT03233529|2923158|Superiority||Least-Square Mean of Difference|-1.3|Standard Error of the Mean|0.36|<|0.0003|2-Sided|95.0|-2.0|-0.6|||Mixed Models Analysis||Comparison at Day 4|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589883|NCT03233529|2923158|Superiority||Least-Square Mean of Difference|-1.2|Standard Error of the Mean|0.36|<|0.0014|2-Sided|95.0|-1.9|-0.4|||Mixed Models Analysis||Comparison at Day 3|Crisaborole ointment 2% was superior to vehicle if p-value was <0.05.|
1589899|NCT03233308|2923206|Other||||||<|0.0087|||||||t-test, 1 sided|||Mean change from baseline (percent difference from baseline) -EVP|
1589904|NCT03232983|2923225|Superiority||Ratio of Geometric LSMeans|1.14|||||2-Sided|90.0|1.04|1.25||||||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.|
1589905|NCT03232983|2923225|Superiority||Ratio of Geometric LSMeans|1.09|||||2-Sided|90.0|1.0|1.2||||||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.|
1589906|NCT03232983|2923226|Superiority||Ratio of Geometric Least Squares Means|1.0|||||2-Sided|90.0|0.962|1.04||||||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.|
1589907|NCT03232983|2923226|Superiority||Ratio of Geometric Least Squares Means|1.03|||||2-Sided|90.0|0.992|1.07||||||Geometric Least Squares Means (LSMeans) were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.|
1589908|NCT03232333|2923240|Superiority||||||=|0|||||||t-test, 1 sided||||
1589909|NCT03232333|2923241|Superiority||||||=|0|||||||t-test, 1 sided||||
1589910|NCT03232333|2923242|Superiority||||||=|0|||||||t-test, 1 sided||||
1589911|NCT03231943|2923247|Other||Power model|0.7397|||||2-Sided|90.0|0.5576|0.9218|||||The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 2||
1589912|NCT03231943|2923248|Other||Power model|0.737|||||2-Sided|90.0|0.5649|0.9091|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2||
1589913|NCT03231943|2923253|Other||Power model|0.7955|||||2-Sided|90.0|0.6562|0.9349|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 2||
1589914|NCT03231943|2923254|Other||Power model|0.789|||||2-Sided|90.0|0.6149|0.9631|||||The statistical model (power model) is based on the PK parameters (Ctrough) from all active doses in Part 2||
1589915|NCT03231943|2923255|Other||Power model|0.7968|||||2-Sided|90.0|0.6424|0.9512|||||The statistical model (power model) is based on the PK parameters (AUC0-tau) from all active doses in Part 1||
1589916|NCT03231943|2923256|Other||Power Model|0.9352|||||2-Sided|90.0|0.897|0.9734|||||The statistical model (power model) is based on the PK parameters (Cmax) from all active doses in Part 1||
1589917|NCT03231943|2923257|Other||Power model|0.928|||||2-Sided|90.0|0.8877|0.9683|||||The statistical model (power model) is based on the PK parameters (AUC0-24) from all active doses in Part 1||
1589918|NCT03231943|2923258|Other||Power model|0.9476|||||2-Sided|90.0|0.8982|0.9971|||||The statistical model (power model) is based on the PK parameters (AUC0-inf) from all active doses in Part 1||
1589919|NCT03231917|2923315|Other|||||||0.48|||||||Chi-squared||||
1589920|NCT03231709|2923321|Other|||||||0.0141|||||||Mainland-Gart Test||||
1589921|NCT03230864|2923333|Superiority||Mean Difference (Final Values)|5.47||||0.0809|2-Sided|95.0|-0.7|11.65|||Mixed Model Repeated Measures|||The mean changes from randomization in PANNS total score was analysed using a mixed model for repeated measures (MMRM) approach. The model will include the fixed, categorical effects of treatment, strata, visit, treatment-by-visit interaction, fixed covariates of baseline scores and baseline scores-by-visit interaction. An unstructured (co)variance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.|
1589922|NCT03228433|2923346|Equivalence|A linear regression model (power model), ln (parameter) = intercept + slope*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 – ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.06||||||90.0|0.96|1.17|||||||
1589923|NCT03228433|2923346|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The LS means and difference of LS means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals CIs.|LS Mean Difference|0.58|||||2-Sided|90.0|0.431|0.781|||||||
1589924|NCT03228433|2923347|Equivalence|A linear regression model (power model), ln (parameter) = intercept + slope*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 – ln (0.8)/l n(r) to 1 + ln (1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.11|||||2-Sided|90.0|1.0|1.22|||||||
1589925|NCT03228433|2923347|Equivalence|Bioequivalence interval of 627.51 to 659.59|LS Mean Difference|0.951|||||2-Sided|90.0|0.825|1.097|||||||
1589926|NCT03228433|2923348|Equivalence|A linear regression model (power model), log (ln) (parameter) equal to (=) intercept plus (+) slope*ln (dose), was fit to describe the relationship between each parameter and the corresponding dose levels. Dose Proportionality was declared if the 90% CI of the slope lied entirely within the critical region as defined by 1 – ln(0.8) per (/)l n(r) to 1 + ln(1.25)/ln(r), where r was the ratio of the highest and lowest dose in the study.|Slope|1.14|||||2-Sided|90.0|1.04|1.25|||||||
1589927|NCT03228433|2923348|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with a fixed effect for regimen and random effect for participant. The least squares(LS) means and difference of least squares (LS) means for the log-transformed parameters were exponentiated to obtain the point estimates (Geometric LS means) of the food effect and 90% confidence intervals (CIs).|Least Squares (LS) Mean Difference|0.951|||||2-Sided|90.0|0.823|1.099|||||||
1589928|NCT03228212|2923355|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|3.3|Standard Deviation|1.5|||2-Sided|95.0|0.36|6.29|||||Mean difference was calculated as Test - Control|Sample size calculations were based on the primary endpoints.|
1589929|NCT03228212|2923356|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|7.2|Standard Deviation|1.8|||2-Sided|95.0|3.69|10.74|||||Mean difference was calculated as Test - Control|Sample size calculations were based on the primary endpoints.|
1589952|NCT03226275|2923429|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.13|||||2-Sided|90.0|0.0|0.5||||||Statistical Comparison of Bisoprolol in Fasting State|
1589930|NCT03228212|2923357|Non-Inferiority|A non-inferiority margin of 5% was used. Upper limit of the 95% credible interval was compared to 5%|Mean Difference (Final Values)|-0.0043|Standard Deviation|0.0089|||2-Sided|95.0|-0.0237|0.0129|||||Mean difference calculated as Test - Control|It was calculated that 120 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect 5% difference between the Test and Control lens with respect to the proportion of eyes with Grade 3 or higher slit lamp findings across all study visits. Sample size was determined using simulations methods. Sample size for this study was primarily driven by the slit lamp findings.|
1589931|NCT03228212|2923358|Non-Inferiority|A non-inferiority margin of 90% was used. Lower limit of 95% credible interval was compared to 90%|proportion|0.992|||||2-Sided|95.0|0.96|1.0||||||It was calculated that 70 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a the 2-week follow-up. Sample size was determined using simulations methods for repeated measures. Analysis was only performed on eyes wearing the Tesl lens.|
1589932|NCT03228212|2923359|Non-Inferiority|A non-inferiority margin of 0.05 logmar was used. This margin corresponds to a half line difference.|Mean Difference (Final Values)|0.02|Standard Deviation|0.00621|||2-Sided|95.0|0.01|0.03|||||Mean difference was calculated as Test - Control|It was calculated that 40 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 0.05 difference in LogMAR visual acuity at the 2-week follow-up. Sample size was determined using simulations methods for repeated measures.|
1589933|NCT03228212|2923360|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|5.1|Standard Deviation|2.0|||2-Sided|95.0|1.16|9.09|||||Mean difference was calculated as Test - Control|It was calculated that 60 participants randomized in a 1:1 fashion between the two sequences would have at least 80% power to detect a 5 points difference in mean overall comfort at the 2-week follow-up. Sample size was determined using Stroup’s Method (alpha=0.05).|
1589934|NCT03227445|2923395|Superiority||Odds Ratio (OR)|6.06|||<|0.001|2-Sided|95.0|2.08|24.55|||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.||
1589935|NCT03227445|2923396|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Supplementary Composite Estimand)|||
1589936|NCT03227445|2923397|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Primary Estimand: Hypothetical)|||
1589937|NCT03227445|2923398|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Supplementary Estimand: Composite)|||
1589938|NCT03227445|2923399|Superiority||Odds Ratio (OR)|8.85|||<|0.001|2-Sided|95.0|3.45||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.||
1589939|NCT03227445|2923404|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|Sensitivity Analyses (Primary Estimand: Hypothetical)|||
1589940|NCT03227445|2923406|Superiority||Odds Ratio (OR)|6.88|||<|0.001|2-Sided|95.0|1.97|54.28|||stratified exact logistic model||Participants included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects.||"There are three intercurrent events identified which could impact upon the estimand of interest:~The participant could withdraw from randomised study device sequence and therefore withdraw from the study~The participant could change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER; these subjects should have been withdrawn from the study according to the protocol.~The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol.~Rescue Medication use and change to maintenance COPD medication which is not delivered via ELLIPTA, DISKUS or HANDIHALER are not considered intercurrent events"
1589941|NCT03226392|2923408|Superiority||Mean Difference (Net)|0.061||||0.448|2-Sided|95.0|-0.07|0.17|||ANCOVA||||
1589942|NCT03226392|2923409|Superiority||Mean Difference (Net)|0.093||||0.893|2-Sided|95.0|-0.2|0.17|||ANCOVA||||
1589943|NCT03226392|2923410|Superiority||Mean Difference (Net)|-0.1||||0.035|2-Sided|0.035|-0.19|0.01|||ANCOVA||||
1589944|NCT03226392|2923411|Superiority||Mean Difference (Net)|-0.031||||0.214|2-Sided|95.0|-0.08|0.018|||ANCOVA||||
1589945|NCT03226275|2923427|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|104.06|||||2-Sided|90.0|96.11|112.66||||||Statistical Comparison of Amlodipine in Fed State|
1589946|NCT03226275|2923427|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.52|||||2-Sided|90.0|89.75|108.15||||||Statistical Comparison of Bisoprolol in Fed State|
1589947|NCT03226275|2923427|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.68|||||2-Sided|90.0|93.38|104.28||||||Statistical Comparison of Amlodipine in Fasting State|
1589948|NCT03226275|2923427|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|99.98|||||2-Sided|90.0|93.61|106.79||||||Statistical Comparison of Bisoprolol in Fasting State|
1589949|NCT03226275|2923429|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||2-Sided|90.0|-1.0|0.5||||||Statistical Comparison of Amlodipine in Fed State|
1589950|NCT03226275|2923429|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||2-Sided|90.0|-1.0|0.5||||||Statistical Comparison of Bisoprolol in Fed State|
1589951|NCT03226275|2923429|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Median Difference|0.0|||||2-Sided|90.0|-1.0|0.0||||||Statistical Comparison of Amlodipine in Fasting State|
1591008|NCT03161938|2925187|Superiority|||||||0.371|||||||Chi-squared, Corrected|||Day 2, sadness|
1589953|NCT03226275|2923430|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|106.56|||||2-Sided|90.0|97.82|116.08||||||Statistical Comparison of Amlodipine in Fed State|
1589954|NCT03226275|2923430|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|93.87|||||2-Sided|90.0|84.56|104.2||||||Statistical Comparison of Bisoprolol in Fed State|
1589955|NCT03226275|2923430|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|100.03|||||2-Sided|90.0|94.37|106.03||||||Statistical Comparison of Amlodipine in Fasting State|
1589956|NCT03226275|2923430|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|97.85|||||2-Sided|90.0|92.29|103.74||||||Statistical Comparison of Bisoprolol in Fasting State|
1589957|NCT03226275|2923431|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|103.07|||||2-Sided|90.0|95.53|111.2||||||Statistical Comparison of Amlodipine in Fed State|
1589958|NCT03226275|2923431|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|98.95|||||2-Sided|90.0|90.02|108.76||||||Statistical Comparison of Bisoprolol in Fed State|
1589959|NCT03226275|2923431|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|96.76|||||2-Sided|90.0|92.95|100.73||||||Statistical Comparison of Amlodipine in Fasting State|
1589960|NCT03226275|2923431|Equivalence|Results based on a mixed-effects model with sequence, treatment, and period as fixed effects and participant nested within sequence as a random effect.|Geometric Least Square Mean Percentage|99.46|||||2-Sided|90.0|93.25|106.09||||||Statistical Comparison of Bisoprolol in Fasting state|
1589961|NCT03224390|2923447|Superiority||Instrumental variables estimate|0.41|||||2-Sided|95.0|-0.03|0.85|||||||
1589962|NCT03224130|2923456|Superiority|||||||0.92|||||||Regression, Logistic||||
1589963|NCT03224130|2923457|Superiority|||||||0.998|||||||Regression, Logistic||||
1589964|NCT03224130|2923458|Superiority|||||||0.5|||||||Regression, Logistic||||
1589965|NCT03224130|2923459|Superiority||||||<|0.01|||||||Poisson model||||
1589966|NCT03224130|2923460|Superiority|||||||0.24|||||||censored Poisson model||||
1589967|NCT03224130|2923461|Superiority|||||||0.31|||||||Regression, Linear||||
1589968|NCT03224130|2923462|Superiority|||||||0.21|||||||Regression, Logistic||||
1589969|NCT03223909|2923463|Non-Inferiority|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.085|||||||Chi-squared, Corrected||||
1589970|NCT03223909|2923464|Non-Inferiority|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.17|||||||ANOVA||||
1589971|NCT03223909|2923465|Non-Inferiority|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.548|||||||ANOVA||||
1589972|NCT03223909|2923466|Non-Inferiority|"the statistical analysis was carried out by intention to treat~It was considered as not inferior when the treatments did not present differences greater than 20%"||||||0.93|||||||Chi-squared||||
1589973|NCT03223909|2923467|Non-Inferiority|It was considered as not inferior when the treatments did not present differences greater than 20% Statistical analysis of Humylub® Ofteno (PRO-087) versus Systane® Ultra PF at the final visit.||||||0.003|||||||ANOVA||||
1589974|NCT03223909|2923467|Non-Inferiority|"It was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis of Humylub® Ofteno (PRO-087) versus Systane® Ultra PF at the final visit."||||||0.003|||||||ANOVA||||
1589975|NCT03223909|2923468|Non-Inferiority|population analysis was per protocol||||||0.65|||||||Wilcoxon (Mann-Whitney)||||
1589976|NCT03223909|2923468|Non-Inferiority|population analysis was per protocol||||||0.0001|||||||ANOVA||||
1589977|NCT03223909|2923469|Non-Inferiority|it was considered as not inferior when the treatments did not present differences greater than 20%||||||0.468|||||||Chi-squared, Corrected||||
1589978|NCT03223909|2923470|Non-Inferiority|"it was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis between groups in the final visit"||||||0.848|||||||ANOVA||||
1589979|NCT03223909|2923470|Non-Inferiority|"it was considered as not inferior when the treatments did not present differences greater than 20%~Statistical analysis of groups in the baseline visit versus final visit"||||||0.08|||||||ANOVA||||
1589980|NCT03223337|2923496|Other||Median Difference (Final Values)|0.0||||0.8042|2-Sided|90.0|0.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1589981|NCT03223337|2923496|Other||Median Difference (Final Values)|0.0||||1|2-Sided|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1589982|NCT03223337|2923496|Other||Median Difference (Final Values)|0.0||||0.8423|2-Sided|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1589983|NCT03223337|2923496|Other||Median Difference (Final Values)|0.0||||0.5207|2-Sided|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1589984|NCT03223337|2923496|Other||Median Difference (Final Values)|0.0||||0.8423|2-Sided|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1589985|NCT03223337|2923496|Other||Median Difference (Final Values)|0.0||||0.8042|2-Sided|90.0|-1.0|0.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1589986|NCT03223337|2923496|Other||Median Difference (Final Values)|0.0||||0.6224|2-Sided|90.0|-1.0|0.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1589987|NCT03223337|2923497|Other||Median Difference (Final Values)|0.0||||0.9837|2-Sided|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1589988|NCT03223337|2923497|Other||Median Difference (Final Values)|0.5||||0.4093|2-Sided|90.0|-1.0|2.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1589989|NCT03223337|2923497|Other||Median Difference (Final Values)|0.0||||0.7716|2-Sided|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2506102 (M5)(Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1589990|NCT03223337|2923497|Other||Median Difference (Final Values)|0.0||||0.588|2-Sided|90.0|-1.0|1.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2487818 (M4)(Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1589991|NCT03223337|2923497|Other||Median Difference (Final Values)|0.0||||0.5767|2-Sided|90.0|-1.0|1.0||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK2391220 (M2)(Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1589992|NCT03223337|2923497|Other||Median Difference (Final Values)|0.0||||0.6822|2-Sided|90.0|-1.0|0.5||P-value was based on Mann-Whitney U test (exact Wilcoxon rank sum test).|Wilcoxon (Mann-Whitney)||Median Difference in GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1589993|NCT03223337|2923498|Other||Ratio of Geometric LS Mean|1.2072|||||2-Sided|90.0|0.9398|1.5508|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1589994|NCT03223337|2923498|Other||Ratio of Geometric LS Mean|1.2721|||||2-Sided|90.0|0.8409|1.9245|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1589995|NCT03223337|2923498|Other||Ratio of Geometric LS Mean|1.0296|||||2-Sided|90.0|0.6996|1.5151|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1589996|NCT03223337|2923498|Other||Ratio of Geometric LS Mean|1.3427|||||2-Sided|90.0|0.7635|2.3615|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1589997|NCT03223337|2923498|Other||Ratio of Geometric LS Mean|1.038|||||2-Sided|90.0|0.7695|1.4002|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1589998|NCT03223337|2923498|Other||Ratio of Geometric LS Mean|1.0143|||||2-Sided|90.0|0.7332|1.4032|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1589999|NCT03223337|2923498|Other||Ratio of Geometric LS Mean|1.0574|||||2-Sided|90.0|0.7876|1.4197|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590000|NCT03223337|2923499|Other||Ratio of Geometric LS Mean|1.0004|||||2-Sided|90.0|0.7833|1.2778|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590001|NCT03223337|2923499|Other||Ratio of Geometric LS Mean|0.9585|||||2-Sided|90.0|0.6664|1.3786|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590002|NCT03223337|2923499|Other||Ratio of Geometric LS Mean|1.1703|||||2-Sided|90.0|0.9|1.5219|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590003|NCT03223337|2923499|Other||Ratio of Geometric LS Mean|0.7299|||||2-Sided|90.0|0.4387|1.2145|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590004|NCT03223337|2923499|Other||Ratio of Geometric LS Mean|0.7415|||||2-Sided|90.0|0.5617|0.9787|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590005|NCT03223337|2923499|Other||Ratio of Geometric LS Mean|0.905|||||2-Sided|90.0|0.69|1.1869|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590006|NCT03223337|2923500|Other||Ratio of Geometric LS Mean|1.3367|||||2-Sided|90.0|0.8288|2.1557|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590007|NCT03223337|2923500|Other||Ratio of Geometric LS Mean|1.8289|||||2-Sided|90.0|1.3992|2.3904|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590008|NCT03223337|2923500|Other||Ratio of Geometric LS Mean|1.6413|||||2-Sided|90.0|1.2055|2.2347|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590009|NCT03223337|2923500|Other||Ratio of Geometric LS Mean|1.7628|||||2-Sided|90.0|1.2898|2.4092|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590010|NCT03223337|2923500|Other||Ratio of Geometric LS Mean|1.7337|||||2-Sided|90.0|1.2343|2.4353|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590011|NCT03223337|2923500|Other||Ratio of Geometric LS Mean|1.7852|||||2-Sided|90.0|1.2498|2.5498|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590012|NCT03223337|2923500|Other||Ratio of Geometric LS Mean|1.0097|||||2-Sided|90.0|0.7122|1.4316|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590013|NCT03223337|2923501|Other||Ratio of Geometric LS Mean|1.0409|||||2-Sided|90.0|0.7927|1.3668|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590014|NCT03223337|2923501|Other||Ratio of Geometric LS Mean|1.2726|||||2-Sided|90.0|0.952|1.7012|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590015|NCT03223337|2923501|Other||Ratio of Geometric LS Mean|1.1802|||||2-Sided|90.0|0.9165|1.5197|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590016|NCT03223337|2923501|Other||Ratio of Geometric LS Mean|1.2487|||||2-Sided|90.0|0.8675|1.7974|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590017|NCT03223337|2923501|Other||Ratio of Geometric LS Mean|1.2791|||||2-Sided|90.0|0.9241|1.7705|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590018|NCT03223337|2923501|Other||Ratio of Geometric LS Mean|1.9786|||||2-Sided|90.0|1.0557|3.7084|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590019|NCT03223337|2923502|Other||Ratio of Geometric LS Mean|1.4646|||||2-Sided|90.0|0.9086|2.3609|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590020|NCT03223337|2923502|Other||Ratio of Geometric LS Mean|1.987|||||2-Sided|90.0|1.5426|2.5594|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590021|NCT03223337|2923502|Other||Ratio of Geometric LS Mean|1.7303|||||2-Sided|90.0|1.2932|2.3151|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590022|NCT03223337|2923502|Other||Ratio of Geometric LS Mean|2.0161|||||2-Sided|90.0|1.4711|2.763|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590023|NCT03223337|2923502|Other||Ratio of Geometric LS Mean|1.8392|||||2-Sided|90.0|1.335|2.534|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590024|NCT03223337|2923502|Other||Ratio of Geometric LS Mean|1.9478|||||2-Sided|90.0|1.3935|2.7224|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590025|NCT03223337|2923502|Other||Ratio of Geometric LS Mean|1.4566|||||2-Sided|90.0|1.0344|2.0513|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590026|NCT03223337|2923503|Other||Ratio of Geometric LS Mean|1.3143|||||2-Sided|90.0|0.9887|1.747|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590027|NCT03223337|2923503|Other||Ratio of Geometric LS Mean|1.624|||||2-Sided|90.0|1.1599|2.2736|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590028|NCT03223337|2923503|Other||Ratio of Geometric LS Mean|1.5169|||||2-Sided|90.0|1.0994|2.093|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590029|NCT03223337|2923503|Other||Ratio of Geometric LS Mean|1.6421|||||2-Sided|90.0|1.0732|2.5125|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590030|NCT03223337|2923503|Other||Ratio of Geometric LS Mean|1.6509|||||2-Sided|90.0|1.1285|2.415|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590031|NCT03223337|2923503|Other||Ratio of Geometric LS Mean|1.9973|||||2-Sided|90.0|1.1061|3.6066|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590032|NCT03223337|2923506|Other||Ratio of Geometric LS Mean|1.4603|||||2-Sided|90.0|0.9081|2.3484|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590033|NCT03223337|2923506|Other||Ratio of Geometric LS Mean|1.974|||||2-Sided|90.0|1.5365|2.536|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590034|NCT03223337|2923506|Other||Ratio of Geometric LS Mean|1.7113|||||2-Sided|90.0|1.2818|2.2847|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590035|NCT03223337|2923506|Other||Ratio of Geometric LS Mean|2.003|||||2-Sided|90.0|1.4654|2.7378|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590036|NCT03223337|2923506|Other||Ratio of Geometric LS Mean|1.8312|||||2-Sided|90.0|1.3342|2.5133|||||Ratio of Geometric LS Mean for GSK2506104 (M3) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590037|NCT03223337|2923506|Other||Ratio of Geometric LS Mean|1.9375|||||2-Sided|90.0|1.3919|2.6968|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590038|NCT03223337|2923506|Other||Ratio of Geometric LS Mean|1.4574|||||2-Sided|90.0|1.035|2.0523|||||Ratio of Geometric LS Mean for GSK1278863 (Mild hepatic impairment participants versus Healthy participants) has been presented.||
1590039|NCT03223337|2923507|Other||Ratio of Geometric LS Mean|1.3145|||||2-Sided|90.0|0.9896|1.7462|||||Ratio of Geometric LS Mean for GSK2531401 (M13) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590040|NCT03223337|2923507|Other||Ratio of Geometric LS Mean|1.6222|||||2-Sided|90.0|1.1594|2.2696|||||Ratio of Geometric LS Mean for GSK2531398 (M6) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590151|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.1|||2-Sided|90.0|-0.3|0.0||||||Change at Week 12, Tandem Walk|
1590041|NCT03223337|2923507|Other||Ratio of Geometric LS Mean|1.4931|||||2-Sided|90.0|1.0876|2.0498|||||Ratio of Geometric LS Mean for GSK2506102 (M5) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590042|NCT03223337|2923507|Other||Ratio of Geometric LS Mean|1.6404|||||2-Sided|90.0|1.0744|2.5048|||||Ratio of Geometric LS Mean for GSK2487818 (M4) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590043|NCT03223337|2923507|Other||Ratio of Geometric LS Mean|1.6471|||||2-Sided|90.0|1.1267|2.4079|||||Ratio of Geometric LS Mean for GSK2391220 (M2) (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590044|NCT03223337|2923507|Other||Ratio of Geometric Least Square(LS) Mean|1.9973|||||2-Sided|90.0|1.1063|3.6057|||||Ratio of Geometric LS Mean for GSK1278863 (Moderate hepatic impairment participants versus Healthy participants) has been presented.||
1590045|NCT03222583|2923511|Non-Inferiority|The percentage of GT2-infected participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 95% if the LCB of the 2-sided 95% CI for the percentage was > 89%.|Percentage of Participants with SVR12|97.8|||||2-Sided|95.0|95.4|100.0||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.|
1590046|NCT03222583|2923512|Non-Inferiority|The percentage of GT1-infected participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 97% if the LCB of the 2-sided 95% CI for the percentage was > 91%.|Percentage of Participants with SVR12|99.4|||||2-Sided|95.0|98.3|100.0||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.|
1590047|NCT03222583|2923513|Non-Inferiority|The percentage of participants in Arm A with SVR12 was non-inferior to the historical SVR12 rate of 96% if the lower confidence bound (LCB) of the 2-sided 95% confidence interval (CI) for the percentage was > 90%.|Percentage of Participants with SVR12|97.2|||||2-Sided|95.0|95.5|98.9||||||In order to control the Type I error rate, a fixed sequence testing procedure was used for the 3 ranked primary efficacy endpoints. Only if success had been demonstrated for the first primary endpoint was testing to proceed to the second primary endpoint. Similarly, only if success had been demonstrated for the second primary endpoint was testing to proceed to the third primary endpoint.|
1590048|NCT03222427|2923519|Other||Ratio of Geometric Least Squares Means|0.952|||||2-Sided|90.0|0.769|1.18|||||||
1590049|NCT03222037|2923531|Equivalence|Statistical significance is declared if the lower limit of the 95% confidence interval is above 0 or if the upper limit of the 95% confidence interval is below 0.|Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.02||0.0066|2-Sided|95.0|0.01|0.08|||Linear Mixed Model|Linear Mixed Model with Kenward and Roger method for the denominator degrees of freedom.|Mean difference was calculated as Test - SCR.|Comparison between the Test and SCR treatments was carried out using least-square mean differences|
1590050|NCT03222037|2923532|Non-Inferiority|Non-inferiority was declared if the upper limit of the 97.5% confidence interval was below 0.05|Median Difference (Final Values)|-0.03|Standard Error of the Mean|0.01|||2-Sided|97.5|-0.06|-0.01|||||Mean difference was calculated as Test- SCR. This comparison is for Low luminance high contrast||
1590051|NCT03222037|2923532|Non-Inferiority|Non-inferiority was declared if the upper limit of the 97.5% confidence interval was below 0.05.|Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.02|||2-Sided|97.5|-0.09|-0.02|||||Mean difference was calculated as Test- SCR. This comparison is for high lumniance low contrast|Comparison between the Test and the SCR treatments was carried out using 97.5% confidence intervals for the least-square mean differences.|
1590052|NCT03218397|2923616|Superiority||Difference in means|-1.9||||0.37|2-Sided|95.0|-5.9|2.2||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-positive antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)||
1590053|NCT03218397|2923617|Superiority||Difference in means|6.5||||0.008|2-Sided|95.0|1.7|11.2||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-negative antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)||
1590054|NCT03218397|2923618|Superiority||Difference in means|4.6||||0.074|2-Sided|95.0|-0.4|9.6||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)||
1590055|NCT03218397|2923619|Superiority||Difference in means|0.7||||0.46|2-Sided|95.0|-1.2|2.7||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-positive antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)||
1590056|NCT03218397|2923620|Superiority||Difference in means|6.5||||0.022|2-Sided|95.0|0.9|12.0||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first gram-negative antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)||
1590057|NCT03218397|2923621|Superiority||Difference in means|7.5||||0.009|2-Sided|95.0|1.9|13.1||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)||
1590058|NCT03218397|2923622|Superiority|||||||0.014||||||alpha = 0.05|Fisher Exact||||
1590059|NCT03218397|2923623|Superiority|||||||0.093||||||alpha = 0.05|t-test, 2 sided|T-test for the difference in mean length of stay (days) between treatment arms among subjects alive at 30 days.|||
1590060|NCT03218397|2923624|Superiority|||||||0.265||||||alpha = 0.05|Fisher Exact||||
1590061|NCT03218397|2923625|Superiority||Difference in means|5.6||||0.013|2-Sided|95.0|1.2|10.0||alpha = 0.05|t-test, 2 sided||Difference in mean hours to first antibiotic modification (Standard Blood Culture and AST minus Rapid Organism Identification and AST)||
1590062|NCT03216746|2923639|Other|||||||0.001|||||||Kruskal-Wallis||||
1590092|NCT03214588|2923685|Superiority|||||||0.411||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1591009|NCT03161938|2925187|Superiority|||||||0.807|||||||Chi-squared, Corrected|||Day 1, fatigue|
1590063|NCT03216265|2923665|Other||Least Square Mean difference|-1.44|||<|0.0001|2-Sided|95.0|-2.1|-0.78|||ANCOVA|Analysis model (ANCOVA) included participant as random effect, treatment arm and side of body as fixed effects, and baseline value as covariate.|Difference is the first named treatment adjusted (LS) mean change from baseline (Visit 2) minus the second named treatment adjusted mean change from baseline (Visit 2).||
1590064|NCT03215758|2923668|Superiority||Mean Difference (Net)|0.069||||0.777|2-Sided|95.0|-0.12|0.15|||ANCOVA||||
1590065|NCT03215758|2923669|Superiority||Mean Difference (Net)|-0.08||||0.429|2-Sided|95.0|-0.3|0.13|||ANCOVA||||
1590066|NCT03215758|2923670|Superiority||Mean Difference (Net)|-0.06||||0.278|2-Sided|95.0|-0.16|0.05|||ANCOVA||||
1590067|NCT03215758|2923671|Superiority||Mean Difference (Net)|0.0238||||0.088|2-Sided|95.0|-0.006|0.088|||ANCOVA||||
1590068|NCT03214588|2923681|Superiority||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 20% Reduction from Baseline|
1590069|NCT03214588|2923681|Superiority||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 20% Reduction from Baseline|
1590070|NCT03214588|2923681|Superiority||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 15% Reduction from Baseline|
1590071|NCT03214588|2923681|Superiority||Odds Ratio (OR)|0.0|||>|0.999||||||P-value was from Fisher's exact test. Odds ratio was obtained from Cochran-Mantel-Haenszel with ambulation status at randomization as a stratification factor.|Fisher Exact|||At Least 15% Reduction from Baseline|
1590072|NCT03214588|2923682|Superiority||Least Squares Mean Difference|0.34|Standard Error of the Mean|0.333||0.846|2-Sided|90.0|-0.21|0.9||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590073|NCT03214588|2923682|Superiority||Least Squares Mean Difference|0.1|Standard Error of the Mean|0.408||0.599|2-Sided|90.0|-0.58|0.79||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590074|NCT03214588|2923682|Superiority||Least Squares Mean Difference|0.33|Standard Error of the Mean|0.279||0.88|2-Sided|90.0|-0.13|0.8||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1590075|NCT03214588|2923682|Superiority||Least Squares Mean Difference|0.02|Standard Error of the Mean|0.338||0.529|2-Sided|90.0|-0.54|0.59||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1590076|NCT03214588|2923682|Superiority||Least Squares Mean Difference|0.55|Standard Error of the Mean|0.293||0.967|2-Sided|90.0|0.06|1.04||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590077|NCT03214588|2923682|Superiority||Least Squares Mean Difference|-0.19|Standard Error of the Mean|0.362||0.299|2-Sided|90.0|-0.8|0.41||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590078|NCT03214588|2923683|Superiority|||||||0.266||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590079|NCT03214588|2923683|Superiority|||||||0.516||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590080|NCT03214588|2923683|Superiority|||||||0.094||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590081|NCT03214588|2923683|Superiority|||||||0.639||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590082|NCT03214588|2923683|Superiority|||||||0.226||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590083|NCT03214588|2923683|Superiority|||||||0.422||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590084|NCT03214588|2923684|Superiority|||||||0.38||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590085|NCT03214588|2923684|Superiority|||||||0.249||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590086|NCT03214588|2923684|Superiority|||||||0.434||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590087|NCT03214588|2923684|Superiority|||||||0.225||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590088|NCT03214588|2923684|Superiority|||||||0.235||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590089|NCT03214588|2923684|Superiority|||||||0.406||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590090|NCT03214588|2923685|Superiority|||||||0.408||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590091|NCT03214588|2923685|Superiority|||||||0.194||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590093|NCT03214588|2923685|Superiority|||||||0.215||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590094|NCT03214588|2923685|Superiority|||||||0.216||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590095|NCT03214588|2923685|Superiority|||||||0.032||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590096|NCT03214588|2923686|Superiority|||||||0.907||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590097|NCT03214588|2923686|Superiority|||||||0.893||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590098|NCT03214588|2923686|Superiority|||||||0.841||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590099|NCT03214588|2923686|Superiority|||||||0.834||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590100|NCT03214588|2923686|Superiority|||||||0.812||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590101|NCT03214588|2923686|Superiority|||||||0.666||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590102|NCT03214588|2923687|Superiority|||||||0.998||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590103|NCT03214588|2923687|Superiority|||||||0.948||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590104|NCT03214588|2923687|Superiority|||||||0.781||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590105|NCT03214588|2923687|Superiority|||||||0.953||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590106|NCT03214588|2923687|Superiority|||||||0.983||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590107|NCT03214588|2923687|Superiority|||||||0.966||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590108|NCT03214588|2923688|Superiority|||||||0.865||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590109|NCT03214588|2923688|Superiority|||||||0.576||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590110|NCT03214588|2923688|Superiority|||||||0.665||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590111|NCT03214588|2923688|Superiority|||||||0.526||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590112|NCT03214588|2923688|Superiority|||||||0.771||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590113|NCT03214588|2923688|Superiority|||||||0.987||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590114|NCT03214588|2923689|Superiority|||||||0.998||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590115|NCT03214588|2923689|Superiority|||||||0.83||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590116|NCT03214588|2923689|Superiority|||||||0.794||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590117|NCT03214588|2923689|Superiority|||||||0.922||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590118|NCT03214588|2923689|Superiority|||||||0.854||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590119|NCT03214588|2923689|Superiority|||||||0.84||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590120|NCT03214588|2923690|Superiority|||||||0.816||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590121|NCT03214588|2923690|Superiority|||||||0.845||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 12|
1590122|NCT03214588|2923690|Superiority|||||||0.793||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1590123|NCT03214588|2923690|Superiority|||||||0.954||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 7|
1599053|NCT02858401|2938156|Other|||||||1|||||||Fisher Exact||||
1590124|NCT03214588|2923690|Superiority|||||||0.893||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590125|NCT03214588|2923690|Superiority|||||||0.974||||||The p-value was obtained using the Cochran-Mantel-Haenszel row mean score test stratified by ambulation status at randomization.|Cochran-Mantel-Haenszel|||Week 2|
1590126|NCT03214588|2923691|Superiority||Least Squares Mean Difference|3.1|Standard Error of the Mean|3.57||0.199|2-Sided|90.0|-2.9|9.0||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590127|NCT03214588|2923691|Superiority||Least Squares Mean Difference|-5.8|Standard Error of the Mean|4.34||0.905|2-Sided|90.0|-13.0|1.5||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590128|NCT03214588|2923691|Superiority||Least Squares Mean Difference|1.4|Standard Error of the Mean|3.0||0.321|2-Sided|90.0|-3.6|6.4||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1590129|NCT03214588|2923691|Superiority||Least Squares Mean Difference|-6.9|Standard Error of the Mean|3.59||0.97|2-Sided|90.0|-12.9|-0.9||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1590130|NCT03214588|2923691|Superiority||Least Squares Mean Difference|3.2|Standard Error of the Mean|3.51||0.182|2-Sided|90.0|-2.7|9.1||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590131|NCT03214588|2923691|Superiority||Least Squares Mean Difference|-2.7|Standard Error of the Mean|4.28||0.735|2-Sided|90.0|-9.9|4.4||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590132|NCT03214588|2923692|Superiority||Least Squares Mean Difference|0.1173|Standard Error of the Mean|0.19778||0.28|2-Sided|90.0|-0.2238|0.4585||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590133|NCT03214588|2923692|Superiority||Least Squares Mean Difference|-0.2067|Standard Error of the Mean|0.28088||0.765|2-Sided|90.0|-0.6911|0.2778||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590134|NCT03214588|2923692|Superiority||Least Squares Mean Difference|0.0113|Standard Error of the Mean|0.23213||0.481|2-Sided|90.0|-0.3891|0.4117||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1590135|NCT03214588|2923692|Superiority||Least Squares Mean Difference|0.1448|Standard Error of the Mean|0.31186||0.324|2-Sided|90.0|-0.3931|0.6826||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1590136|NCT03214588|2923692|Superiority||Least Squares Mean Difference|-0.3281|Standard Error of the Mean|0.15794||0.975|2-Sided|90.0|-0.6005|-0.0557||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590137|NCT03214588|2923692|Superiority||Least Squares Mean Difference|0.045|Standard Error of the Mean|0.23858||0.426|2-Sided|90.0|-0.3665|0.4565||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590138|NCT03214588|2923693|Superiority||Least Squares Mean Difference|0.78|Standard Error of the Mean|0.819||0.825|2-Sided|90.0|-0.63|2.19||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590139|NCT03214588|2923693|Superiority||Least Squares Mean Difference|2.18|Standard Error of the Mean|1.078||0.972|2-Sided|90.0|0.32|4.04||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590140|NCT03214588|2923693|Superiority||Least Squares Mean Difference|-0.3|Standard Error of the Mean|0.886||0.37|2-Sided|90.0|-1.83|1.23||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1590141|NCT03214588|2923693|Superiority||Least Squares Mean Difference|0.09|Standard Error of the Mean|1.14||0.533|2-Sided|90.0|-1.87|2.06||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1590142|NCT03214588|2923693|Superiority||Least Squares Mean Difference|1.34|Standard Error of the Mean|0.625||0.978|2-Sided|90.0|0.26|2.42||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590143|NCT03214588|2923693|Superiority||Least Squares Mean Difference|0.23|Standard Error of the Mean|0.889||0.599|2-Sided|90.0|-1.31|1.76||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590144|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.3|Standard Error of the Mean|0.14|||2-Sided|90.0|0.0|0.5||||||Change at Week 12, Gait|
1590145|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.17|||2-Sided|90.0|-0.4|0.2||||||Change at Week 12, Gait|
1590146|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.3|Standard Error of the Mean|0.15|||2-Sided|90.0|0.1|0.6||||||Change at Week 7, Gait|
1590147|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.17|||2-Sided|90.0|-0.4|0.2||||||Change at Week 7, Gait|
1590148|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.4|Standard Error of the Mean|0.17|||2-Sided|90.0|0.1|0.7||||||Change at Week 2, Gait|
1590149|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.1|Standard Error of the Mean|0.2|||2-Sided|90.0|-0.2|0.4||||||Change at Week 2, Gait|
1591019|NCT03161938|2925188|Superiority||||||>|0.999|||||||Chi-squared, Corrected|||day 0|
1590152|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.07|||2-Sided|90.0|-0.1|0.1||||||Change at Week 7, Tandem Walk|
1590153|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.09|||2-Sided|90.0|-0.2|0.1||||||Change at Week 7, Tandem Walk|
1590154|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.07|||2-Sided|90.0|-0.1|0.1||||||Change at Week 2, Tandem Walk|
1590155|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.08|||2-Sided|90.0|-0.1|0.1||||||Change at Week 2, Tandem Walk|
1590156|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.07|||2-Sided|90.0|-0.1|0.2||||||Change at Week 12, Tandem Stance – TTA|
1590157|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.09|||2-Sided|90.0|-0.2|0.1||||||Change at Week 12, Tandem Stance – TTA|
1590158|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.1|Standard Error of the Mean|0.07|||2-Sided|90.0|-0.1|0.2||||||Change at Week 7, Tandem Stance – TTA|
1590159|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.09|||2-Sided|90.0|-0.2|0.0||||||Change at Week 7, Tandem Stance – TTA|
1590160|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.07|||2-Sided|90.0|-0.1|0.1||||||Change at Week 2, Tandem Stance – TTA|
1590161|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.09|||2-Sided|90.0|-0.2|0.1||||||Change at Week 2, Tandem Stance – TTA|
1590162|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.2|Standard Error of the Mean|0.09|||2-Sided|90.0|-0.3|0.0||||||Change at Week 12, SFT (Eyes Closed) – TTA|
1590163|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.11|||2-Sided|90.0|-0.2|0.2||||||Change at Week 12, SFT (Eyes Closed) – TTA|
1590164|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.09|||2-Sided|90.0|-0.1|0.2||||||Change at Week 7, SFT (Eyes Closed) – TTA|
1590165|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.11|||2-Sided|90.0|-0.2|0.2||||||Change at Week 7, SFT (Eyes Closed) – TTA|
1590166|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.09|||2-Sided|90.0|-0.2|0.1||||||Change at Week 2, SFT (Eyes Closed) – TTA|
1590167|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.11|||2-Sided|90.0|-0.2|0.1||||||Change at Week 2, SFT (Eyes Closed) – TTA|
1590168|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.3|Standard Error of the Mean|0.19|||2-Sided|90.0|0.0|0.7||||||Change at Week 12, SFT – TTA|
1590169|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.5|0.2||||||Change at Week 12, SFT – TTA|
1590170|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.4|Standard Error of the Mean|0.15|||2-Sided|90.0|0.2|0.7||||||Change at Week 7, SFT – TTA|
1590171|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.3|0.4||||||Change at Week 7, SFT – TTA|
1590172|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.4|Standard Error of the Mean|0.26|||2-Sided|90.0|0.0|0.8||||||Change at Week 2, SFT – TTA|
1590173|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.3|Standard Error of the Mean|0.32|||2-Sided|90.0|-0.8|0.2||||||Change at Week 2, SFT – TTA|
1590174|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.2|Standard Error of the Mean|0.19|||2-Sided|90.0|-0.5|0.1||||||Change at Week 12, SFA (Eyes Closed) – TTA|
1590175|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.3|0.4||||||Change at Week 12, SFA (Eyes Closed) – TTA|
1590176|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.2|Standard Error of the Mean|0.16|||2-Sided|90.0|-0.4|0.1||||||Change at Week 7, SFA (Eyes Closed) – TTA|
1590177|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.19|||2-Sided|90.0|-0.4|0.2||||||Change at Week 7, SFA (Eyes Closed) – TTA|
1590178|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.09|||2-Sided|90.0|-0.2|0.1||||||Change at Week 2, SFA (Eyes Closed) – TTA|
1590179|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.1|Standard Error of the Mean|0.11|||2-Sided|90.0|-0.1|0.3||||||Change at Week 2, SFA (Eyes Closed) – TTA|
1590180|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.1|Standard Error of the Mean|0.19|||2-Sided|90.0|-0.2|0.4||||||Change at Week 12, SFA – TTA|
1590181|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.22|||2-Sided|90.0|-0.3|0.4||||||Change at Week 12, SFA – TTA|
1590182|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.2|Standard Error of the Mean|0.17|||2-Sided|90.0|-0.5|0.1||||||Change at Week 7, SFA – TTA|
1590183|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.2|||2-Sided|90.0|-0.4|0.2||||||Change at Week 7, SFA – TTA|
1590184|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.2|||2-Sided|90.0|-0.3|0.3||||||Change at Week 2, SFA – TTA|
1590185|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.25|||2-Sided|90.0|-0.4|0.4||||||Change at Week 2, SFA – TTA|
1590186|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.1|Standard Error of the Mean|0.16|||2-Sided|90.0|-0.2|0.3||||||Change at Week 12, Siting Posture|
1590187|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.19|||2-Sided|90.0|-0.5|0.2||||||Change at Week 12, Siting Posture|
1590188|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.2|Standard Error of the Mean|0.15|||2-Sided|90.0|0.0|0.5||||||Change at Week 7, Siting Posture|
1590189|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.4|0.2||||||Change at Week 7, Siting Posture|
1590190|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.2|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.1|0.4||||||Change at Week 2, Siting Posture|
1590191|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.2|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.1|0.5||||||Change at Week 2, Siting Posture|
1590192|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.25|Standard Error of the Mean|0.25|||2-Sided|90.0|-0.17|0.67||||||Change at Week 12, Left Heel Along Shin Tap|
1590193|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.31|Standard Error of the Mean|0.303|||2-Sided|90.0|-0.2|0.82||||||Change at Week 12, Left Heel Along Shin Tap|
1590194|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.21|Standard Error of the Mean|0.234|||2-Sided|90.0|-0.19|0.6||||||Change at Week 7, Left Heel Along Shin Tap|
1590195|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.37|Standard Error of the Mean|0.277|||2-Sided|90.0|-0.09|0.84||||||Change at Week 7, Left Heel Along Shin Tap|
1590196|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.34|Standard Error of the Mean|0.164|||2-Sided|90.0|0.06|0.61||||||Change at Week 2, Left Heel Along Shin Tap|
1590197|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.16|Standard Error of the Mean|0.199|||2-Sided|90.0|-0.17|0.5||||||Change at Week 2, Left Heel Along Shin Tap|
1590198|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.33|Standard Error of the Mean|0.186|||2-Sided|90.0|0.02|0.64||||||Change at Week 12, Right Heel Along Shin Tap|
1590199|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.14|Standard Error of the Mean|0.222|||2-Sided|90.0|-0.23|0.51||||||Change at Week 12, Right Heel Along Shin Tap|
1590200|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.231|||2-Sided|90.0|-0.38|0.39||||||Change at Week 7, Right Heel Along Shin Tap|
1590201|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.27|Standard Error of the Mean|0.272|||2-Sided|90.0|-0.72|0.19||||||Change at Week 7, Right Heel Along Shin Tap|
1590202|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.43|Standard Error of the Mean|0.155|||2-Sided|90.0|0.17|0.69||||||Change at Week 2, Right Heel Along Shin Tap|
1590203|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.22|Standard Error of the Mean|0.187|||2-Sided|90.0|-0.1|0.53||||||Change at Week 2, Right Heel Along Shin Tap|
1590204|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.01|Standard Error of the Mean|0.209|||2-Sided|90.0|-0.34|0.36||||||Change at Week 12, Left Heel Along Shin Slide|
1590205|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.02|Standard Error of the Mean|0.254|||2-Sided|90.0|-0.45|0.4||||||Change at Week 12, Left Heel Along Shin Slide|
1590206|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.17|Standard Error of the Mean|0.188|||2-Sided|90.0|-0.48|0.15||||||Change at Week 7, Left Heel Along Shin Slide|
1590207|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.31|Standard Error of the Mean|0.224|||2-Sided|90.0|-0.68|0.07||||||Change at Week 7, Left Heel Along Shin Slide|
1590208|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.03|Standard Error of the Mean|0.166|||2-Sided|90.0|-0.25|0.31||||||Change at Week 2, Left Heel Along Shin Slide|
1590209|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.17|Standard Error of the Mean|0.205|||2-Sided|90.0|-0.51|0.18||||||Change at Week 2, Left Heel Along Shin Slide|
1590210|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.13|Standard Error of the Mean|0.226|||2-Sided|90.0|-0.25|0.51||||||Change at Week 12,Right Heel Along Shin Slide|
1590211|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.33|Standard Error of the Mean|0.27|||2-Sided|90.0|-0.12|0.78||||||Change at Week 12,Right Heel Along Shin Slide|
1590212|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.17|Standard Error of the Mean|0.214|||2-Sided|90.0|-0.53|0.19||||||Change at Week 7, Right Heel Along Shin Slide|
1590213|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.14|Standard Error of the Mean|0.251|||2-Sided|90.0|-0.56|0.28||||||Change at Week 7, Right Heel Along Shin Slide|
1590214|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.01|Standard Error of the Mean|0.161|||2-Sided|90.0|-0.26|0.27||||||Change at Week 2, Right Heel Along Shin Slide|
1590215|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.2|Standard Error of the Mean|0.193|||2-Sided|90.0|-0.12|0.53||||||Change at Week 2, Right Heel Along Shin Slide|
1590216|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.33|Standard Error of the Mean|0.224|||2-Sided|90.0|-0.04|0.71||||||Change at Week 12, Left Finger Taps|
1590217|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.57|Standard Error of the Mean|0.272|||2-Sided|90.0|0.11|1.02||||||Change at Week 12, Left Finger Taps|
1590218|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.16|Standard Error of the Mean|0.184|||2-Sided|90.0|-0.15|0.47||||||Change at Week 7, Left Finger Taps|
1590219|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.59|Standard Error of the Mean|0.218|||2-Sided|90.0|0.22|0.95||||||Change at Week 7, Left Finger Taps|
1590220|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.05|Standard Error of the Mean|0.183|||2-Sided|90.0|-0.25|0.36||||||Change at Week 2, Left Finger Taps|
1590221|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.5|Standard Error of the Mean|0.223|||2-Sided|90.0|0.12|0.87||||||Change at Week 2, Left Finger Taps|
1590222|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.07|Standard Error of the Mean|0.194|||2-Sided|90.0|-0.39|0.26||||||Change at Week 12, Right Finger Taps|
1590223|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.17|Standard Error of the Mean|0.233|||2-Sided|90.0|-0.22|0.56||||||Change at Week 12, Right Finger Taps|
1590224|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.01|Standard Error of the Mean|0.193|||2-Sided|90.0|-0.33|0.31||||||Change at Week 7, Right Finger Taps|
1590225|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.22|Standard Error of the Mean|0.227|||2-Sided|90.0|-0.16|0.6||||||Change at Week 7, Right Finger Taps|
1590226|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.16|Standard Error of the Mean|0.168|||2-Sided|90.0|-0.12|0.44||||||Change at Week 2, Right Finger Taps|
1590227|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.44|Standard Error of the Mean|0.201|||2-Sided|90.0|0.1|0.77||||||Change at Week 2, Right Finger Taps|
1590228|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.21|Standard Error of the Mean|0.132|||2-Sided|90.0|-0.01|0.43||||||Change at Week 12, RAM of Left Hand|
1590229|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.31|Standard Error of the Mean|0.159|||2-Sided|90.0|0.04|0.58||||||Change at Week 12, RAM of Left Hand|
1590230|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.12|Standard Error of the Mean|0.176|||2-Sided|90.0|-0.17|0.42||||||Change at Week 7, RAM of Left Hands|
1590231|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.08|Standard Error of the Mean|0.209|||2-Sided|90.0|-0.27|0.43||||||Change at Week 7, RAM of Left Hands|
1590232|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.08|Standard Error of the Mean|0.116|||2-Sided|90.0|-0.12|0.27||||||Change at Week 2, RAM of Left Hands|
1590233|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.08|Standard Error of the Mean|0.141|||2-Sided|90.0|-0.15|0.32||||||Change at Week 2, RAM of Left Hands|
1590234|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.05|Standard Error of the Mean|0.156|||2-Sided|90.0|-0.31|0.21||||||Change at Week 12, RAM of Right Hands|
1590235|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.19|Standard Error of the Mean|0.187|||2-Sided|90.0|-0.12|0.51||||||Change at Week 12, RAM of Right Hands|
1590236|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.172|||2-Sided|90.0|-0.29|0.29||||||Change at Week 7, RAM of Right Hands|
1590237|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.06|Standard Error of the Mean|0.204|||2-Sided|90.0|-0.41|0.28||||||Change at Week 7, RAM of Right Hands|
1590238|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.11|Standard Error of the Mean|0.141|||2-Sided|90.0|-0.12|0.35||||||Change at Week 2, RAM of Right Hands|
1590239|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.22|Standard Error of the Mean|0.17|||2-Sided|90.0|-0.06|0.51||||||Change at Week 2, RAM of Right Hands|
1590240|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.23|Standard Error of the Mean|0.209|||2-Sided|90.0|-0.11|0.58||||||Change at Week 12, Left Dysmetria Test|
1590241|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.06|Standard Error of the Mean|0.254|||2-Sided|90.0|-0.37|0.48||||||Change at Week 12, Left Dysmetria Test|
1590242|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.14|Standard Error of the Mean|0.192|||2-Sided|90.0|-0.47|0.18||||||Change at Week 7, Left Dysmetria Test|
1590243|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.25|Standard Error of the Mean|0.228|||2-Sided|90.0|-0.63|0.13||||||Change at Week 7, Left Dysmetria Test|
1590244|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.15|Standard Error of the Mean|0.153|||2-Sided|90.0|-0.1|0.41||||||Change at Week 2, Left Dysmetria Test|
1590245|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.29|Standard Error of the Mean|0.185|||2-Sided|90.0|-0.02|0.6||||||Change at Week 2, Left Dysmetria Test|
1590246|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.06|Standard Error of the Mean|0.183|||2-Sided|90.0|-0.36|0.25||||||Change at Week 12, Right Dysmetria Test|
1590247|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.11|Standard Error of the Mean|0.221|||2-Sided|90.0|-0.26|0.48||||||Change at Week 12, Right Dysmetria Test|
1590248|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.17|Standard Error of the Mean|0.183|||2-Sided|90.0|-0.14|0.47||||||Change at Week 7, Right Dysmetria Test|
1590249|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.12|Standard Error of the Mean|0.217|||2-Sided|90.0|-0.25|0.48||||||Change at Week 7, Right Dysmetria Test|
1590250|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.12|Standard Error of the Mean|0.145|||2-Sided|90.0|-0.12|0.36||||||Change at Week 2, Right Dysmetria Test|
1590251|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.04|Standard Error of the Mean|0.176|||2-Sided|90.0|-0.33|0.26||||||Change at Week 2, Right Dysmetria Test|
1590252|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.03|Standard Error of the Mean|0.141|||2-Sided|90.0|-0.21|0.27||||||Change at Week 12, Left Nose to Finger Test|
1590253|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.01|Standard Error of the Mean|0.169|||2-Sided|90.0|-0.29|0.27||||||Change at Week 12, Left Nose to Finger Test|
1590254|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.13|Standard Error of the Mean|0.134|||2-Sided|90.0|-0.36|0.09||||||Change at Week 7, Left Nose to Finger Test|
1590255|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.17|Standard Error of the Mean|0.157|||2-Sided|90.0|-0.09|0.43||||||Change at Week 7, Left Nose to Finger Test|
1590256|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.1|Standard Error of the Mean|0.133|||2-Sided|90.0|-0.12|0.33||||||Change at Week 2, Left Nose to Finger Test|
1590257|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.13|Standard Error of the Mean|0.161|||2-Sided|90.0|-0.14|0.4||||||Change at Week 2, Left Nose to Finger Test|
1590258|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.136|||2-Sided|90.0|-0.23|0.23||||||Change at Week 12, Right Nose to Finger Test|
1590259|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.15|Standard Error of the Mean|0.166|||2-Sided|90.0|-0.43|0.12||||||Change at Week 12, Right Nose to Finger Test|
1590260|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.08|Standard Error of the Mean|0.146|||2-Sided|90.0|-0.32|0.16||||||Change at Week 7, Right Nose to Finger Test|
1590261|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.07|Standard Error of the Mean|0.174|||2-Sided|90.0|-0.22|0.37||||||Change at Week 7, Right Nose to Finger Test|
1590262|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.14|Standard Error of the Mean|0.118|||2-Sided|90.0|-0.06|0.33||||||Change at Week 2, Right Nose to Finger Test|
1590263|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.29|Standard Error of the Mean|0.145|||2-Sided|90.0|0.04|0.53||||||Change at Week 2, Right Nose to Finger Test|
1590264|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.09|Standard Error of the Mean|0.13|||2-Sided|90.0|-0.3|0.13||||||Change at Week 12, Left Finger to Finger Test|
1590265|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.09|Standard Error of the Mean|0.158|||2-Sided|90.0|-0.17|0.36||||||Change at Week 12, Left Finger to Finger Test|
1590266|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.03|Standard Error of the Mean|0.104|||2-Sided|90.0|-0.15|0.2||||||Change at Week 7, Left Finger to Finger Test|
1590267|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.03|Standard Error of the Mean|0.123|||2-Sided|90.0|-0.18|0.23||||||Change at Week 7, Left Finger to Finger Test|
1590268|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.04|Standard Error of the Mean|0.117|||2-Sided|90.0|-0.16|0.23||||||Change at Week 2, Left Finger to Finger Test|
1590269|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.09|Standard Error of the Mean|0.142|||2-Sided|90.0|-0.15|0.33||||||Change at Week 2, Left Finger to Finger Test|
1590270|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.14|Standard Error of the Mean|0.104|||2-Sided|90.0|-0.32|0.03||||||Change at Week 12, Right Finger to Finger Test|
1590271|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.09|Standard Error of the Mean|0.126|||2-Sided|90.0|-0.3|0.12||||||Change at Week 12, Right Finger to Finger Test|
1590272|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.07|Standard Error of the Mean|0.103|||2-Sided|90.0|-0.24|0.11||||||Change at Week 7, Right Finger to Finger Test|
1590273|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.07|Standard Error of the Mean|0.122|||2-Sided|90.0|-0.13|0.28||||||Change at Week 7, Right Finger to Finger Test|
1590274|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.04|Standard Error of the Mean|0.108|||2-Sided|90.0|-0.22|0.14||||||Change at Week 2, Right Finger to Finger Test|
1590275|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.07|Standard Error of the Mean|0.131|||2-Sided|90.0|-0.14|0.29||||||Change at Week 2, Right Finger to Finger Test|
1590276|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.09|Standard Error of the Mean|0.079|||2-Sided|90.0|-0.04|0.22||||||Change at Week 12, Speech|
1590277|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.095|||2-Sided|90.0|-0.16|0.16||||||Change at Week 12, Speech|
1590278|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.07|Standard Error of the Mean|0.06|||2-Sided|90.0|-0.03|0.17||||||Change at Week 7, Speech|
1590279|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.04|Standard Error of the Mean|0.071|||2-Sided|90.0|-0.16|0.08||||||Change at Week 7, Speech|
1590280|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.1|Standard Error of the Mean|0.083|||2-Sided|90.0|-0.04|0.24||||||Change at Week 2, Speech|
1590281|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.08|Standard Error of the Mean|0.1|||2-Sided|90.0|-0.09|0.25||||||Change at Week 2, Speech|
1590282|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.12|Standard Error of the Mean|0.087|||2-Sided|90.0|-0.03|0.26||||||Change at Week 12, Cough|
1590283|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.07|Standard Error of the Mean|0.106|||2-Sided|90.0|-0.11|0.25||||||Change at Week 12, Cough|
1590284|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.1|Standard Error of the Mean|0.088|||2-Sided|90.0|-0.05|0.25||||||Change at Week 7, Cough|
1590285|NCT03214588|2923694|Superiority||Least Squares Mean Difference|-0.06|Standard Error of the Mean|0.105|||2-Sided|90.0|-0.24|0.11||||||Change at Week 7, Cough|
1590286|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.069|||2-Sided|90.0|-0.11|0.12||||||Change at Week 2, Cough|
1590287|NCT03214588|2923694|Superiority||Least Squares Mean Difference|0.01|Standard Error of the Mean|0.084|||2-Sided|90.0|-0.13|0.15||||||Change at Week 2, Cough|
1590288|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.5|Standard Error of the Mean|0.48|||2-Sided|90.0|-0.3|1.3||||||Change at Week 12, Upright Stability|
1590289|NCT03214588|2923695|Superiority||Least Squares Mean Difference|-0.2|Standard Error of the Mean|0.57|||2-Sided|90.0|-1.2|0.7||||||Change at Week 12, Upright Stability|
1590290|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.6|Standard Error of the Mean|0.38|||2-Sided|90.0|0.0|1.2||||||Change at Week 7, Upright Stability|
1590291|NCT03214588|2923695|Superiority||Least Squares Mean Difference|-0.5|Standard Error of the Mean|0.45|||2-Sided|90.0|-1.3|0.2||||||Change at Week 7, Upright Stability|
1590292|NCT03214588|2923695|Superiority||Least Squares Mean Difference|1.0|Standard Error of the Mean|0.52|||2-Sided|90.0|0.1|1.9||||||Change at Week 2, Upright Stability|
1590293|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.2|Standard Error of the Mean|0.63|||2-Sided|90.0|-0.8|1.3||||||Change at Week 2, Upright Stability|
1590294|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.95|Standard Error of the Mean|0.626|||2-Sided|90.0|-0.09|2.0||||||Change at Week 12, Lower Limb Coordination|
1590295|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.99|Standard Error of the Mean|0.755|||2-Sided|90.0|-0.27|2.25||||||Change at Week 12, Lower Limb Coordination|
1590296|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.17|Standard Error of the Mean|0.707|||2-Sided|90.0|-1.01|1.36||||||Change at Week 7, Lower Limb Coordination|
1590297|NCT03214588|2923695|Superiority||Least Squares Mean Difference|-0.04|Standard Error of the Mean|0.837|||2-Sided|90.0|-1.44|1.36||||||Change at Week 7, Lower Limb Coordination|
1590298|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.79|Standard Error of the Mean|0.397|||2-Sided|90.0|0.12|1.45||||||Change at Week 2, Lower Limb Coordination|
1590299|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.4|Standard Error of the Mean|0.482|||2-Sided|90.0|-0.41|1.2||||||Change at Week 2, Lower Limb Coordination|
1590300|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.53|Standard Error of the Mean|0.84|||2-Sided|90.0|-0.87|1.94||||||Change at Week 12, Upper Limb Coordination|
1590301|NCT03214588|2923695|Superiority||Least Squares Mean Difference|1.21|Standard Error of the Mean|1.016|||2-Sided|90.0|-0.48|2.91||||||Change at Week 12, Upper Limb Coordination|
1590302|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.18|Standard Error of the Mean|0.743|||2-Sided|90.0|-1.06|1.43||||||Change at Week 7, Upper Limb Coordination|
1590303|NCT03214588|2923695|Superiority||Least Squares Mean Difference|1.08|Standard Error of the Mean|0.882|||2-Sided|90.0|-0.4|2.55||||||Change at Week 7, Upper Limb Coordination|
1590304|NCT03214588|2923695|Superiority||Least Squares Mean Difference|1.02|Standard Error of the Mean|0.571|||2-Sided|90.0|0.06|1.97||||||Change at Week 2, Upper Limb Coordination|
1590305|NCT03214588|2923695|Superiority||Least Squares Mean Difference|1.99|Standard Error of the Mean|0.689|||2-Sided|90.0|0.83|3.14||||||Change at Week 2, Upper Limb Coordination|
1590306|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.2|Standard Error of the Mean|0.118|||2-Sided|90.0|0.0|0.4||||||Change at Week 12, Bulbar|
1590307|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.05|Standard Error of the Mean|0.141|||2-Sided|90.0|-0.19|0.28||||||Change at Week 12, Bulbar|
1590308|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.16|Standard Error of the Mean|0.104|||2-Sided|90.0|-0.02|0.33||||||Change at Week 7, Bulbar|
1591010|NCT03161938|2925187|Superiority|||||||0.052|||||||Chi-squared, Corrected|||Day 1, restlessness|
1590309|NCT03214588|2923695|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.122|||2-Sided|90.0|-0.3|0.11||||||Change at Week 7, Bulbar|
1590310|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.06|Standard Error of the Mean|0.11|||2-Sided|90.0|-0.12|0.25||||||Change at Week 2, Bulbar|
1590311|NCT03214588|2923695|Superiority||Least Squares Mean Difference|0.07|Standard Error of the Mean|0.133|||2-Sided|90.0|-0.15|0.29||||||Change at Week 2, Bulbar|
1590312|NCT03214588|2923696|Superiority||Least Squares Mean Difference|2.11|Standard Error of the Mean|1.053||0.975|2-Sided|90.0|0.35|3.87||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590313|NCT03214588|2923696|Superiority||Least Squares Mean Difference|2.02|Standard Error of the Mean|1.266||0.942|2-Sided|90.0|-0.1|4.13||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590314|NCT03214588|2923696|Superiority||Least Squares Mean Difference|1.06|Standard Error of the Mean|1.131||0.823|2-Sided|90.0|-0.83|2.95||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1590315|NCT03214588|2923696|Superiority||Least Squares Mean Difference|0.4|Standard Error of the Mean|1.338||0.616|2-Sided|90.0|-1.84|2.64||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1590316|NCT03214588|2923696|Superiority||Least Squares Mean Difference|2.78|Standard Error of the Mean|0.892||0.999|2-Sided|90.0|1.29|4.28||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590317|NCT03214588|2923696|Superiority||Least Squares Mean Difference|2.67|Standard Error of the Mean|1.078||0.992|2-Sided|90.0|0.86|4.47||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590318|NCT03214588|2923697|Superiority||Least Squares Mean Difference|0.06|Standard Error of the Mean|0.151||0.661|2-Sided|90.0|-0.19|0.32||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Personal Hygiene|
1590319|NCT03214588|2923697|Superiority||Least Squares Mean Difference|0.07|Standard Error of the Mean|0.184||0.649|2-Sided|90.0|-0.24|0.38||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Personal Hygiene|
1590320|NCT03214588|2923697|Superiority||Least Squares Mean Difference|0.06|Standard Error of the Mean|0.158||0.658|2-Sided|90.0|-0.2|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Personal Hygiene|
1590321|NCT03214588|2923697|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.193||0.505|2-Sided|90.0|-0.32|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Personal Hygiene|
1590322|NCT03214588|2923697|Superiority||Least Squares Mean Difference|0.2|Standard Error of the Mean|0.123||0.946|2-Sided|90.0|0.0|0.41||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Personal Hygiene|
1590323|NCT03214588|2923697|Superiority||Least Squares Mean Difference|-0.06|Standard Error of the Mean|0.151||0.358|2-Sided|90.0|-0.31|0.2||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Personal Hygiene|
1590324|NCT03214588|2923697|Superiority||Least Squares Mean Difference|-0.03|Standard Error of the Mean|0.129||0.411|2-Sided|90.0|-0.24|0.19||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Dressing|
1590325|NCT03214588|2923697|Superiority||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.157||0.268|2-Sided|90.0|-0.36|0.17||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Dressing|
1590326|NCT03214588|2923697|Superiority||Least Squares Mean Difference|-0.04|Standard Error of the Mean|0.1||0.359|2-Sided|90.0|-0.2|0.13||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Dressing|
1590344|NCT03214588|2923699|Superiority||Least Squares Mean Difference|0.59|Standard Error of the Mean|0.64||0.818|2-Sided|90.0|-0.48|1.66||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590327|NCT03214588|2923697|Superiority||Least Squares Mean Difference|-0.02|Standard Error of the Mean|0.12||0.443|2-Sided|90.0|-0.22|0.18||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Dressing|
1590328|NCT03214588|2923697|Superiority||Least Squares Mean Difference|0.13|Standard Error of the Mean|0.119||0.861|2-Sided|90.0|-0.07|0.33||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Dressing|
1590329|NCT03214588|2923697|Superiority||Least Squares Mean Difference|-0.15|Standard Error of the Mean|0.148||0.153|2-Sided|90.0|-0.4|0.09||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Dressing|
1590330|NCT03214588|2923697|Superiority||Least Squares Mean Difference|0.3|Standard Error of the Mean|0.133||0.986|2-Sided|90.0|0.08|0.52||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Cutting-Handling Utensils|
1590331|NCT03214588|2923697|Superiority||Least Squares Mean Difference|0.09|Standard Error of the Mean|0.162||0.718|2-Sided|90.0|-0.18|0.37||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 12, Cutting-Handling Utensils|
1590332|NCT03214588|2923697|Superiority||Least Squares Mean Difference|0.31|Standard Error of the Mean|0.138||0.986|2-Sided|90.0|0.08|0.54||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Cutting-Handling Utensils|
1590333|NCT03214588|2923697|Superiority||Least Squares Mean Difference|0.01|Standard Error of the Mean|0.165||0.515|2-Sided|90.0|-0.27|0.28||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 7, Cutting-Handling Utensils|
1590334|NCT03214588|2923697|Superiority||Least Squares Mean Difference|0.23|Standard Error of the Mean|0.126||0.963|2-Sided|90.0|0.02|0.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Cutting-Handling Utensils|
1590335|NCT03214588|2923697|Superiority||Least Squares Mean Difference|0.03|Standard Error of the Mean|0.154||0.571|2-Sided|90.0|-0.23|0.29||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA||MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Change at Week 2, Cutting-Handling Utensils|
1590336|NCT03214588|2923698|Superiority||Least Squares Mean Difference|-0.00044|Standard Error of the Mean|0.000646||0.749|2-Sided|90.0|-0.00152|0.00064||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1590337|NCT03214588|2923698|Superiority||Least Squares Mean Difference|-0.00014|Standard Error of the Mean|0.000772||0.573|2-Sided|90.0|-0.00143|0.00115||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1590338|NCT03214588|2923698|Superiority||Least Squares Mean Difference|-0.00093|Standard Error of the Mean|0.000505||0.964|2-Sided|90.0|-0.00177|-0.00008||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590339|NCT03214588|2923698|Superiority||Least Squares Mean Difference|-0.00039|Standard Error of the Mean|0.000604||0.741|2-Sided|90.0|-0.0014|0.00062||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590340|NCT03214588|2923699|Superiority||Least Squares Mean Difference|0.37|Standard Error of the Mean|0.679||0.708|2-Sided|90.0|-0.76|1.51||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590341|NCT03214588|2923699|Superiority||Least Squares Mean Difference|0.24|Standard Error of the Mean|0.822||0.616|2-Sided|90.0|-1.13|1.62||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590342|NCT03214588|2923699|Superiority||Least Squares Mean Difference|0.36|Standard Error of the Mean|0.643||0.713|2-Sided|90.0|-0.71|1.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1590343|NCT03214588|2923699|Superiority||Least Squares Mean Difference|0.18|Standard Error of the Mean|0.77||0.591|2-Sided|90.0|-1.11|1.47||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 7|
1591011|NCT03161938|2925187|Superiority|||||||0.731|||||||Chi-squared, Corrected|||Day 1, sadness|
1590345|NCT03214588|2923699|Superiority||Least Squares Mean Difference|-0.87|Standard Error of the Mean|0.782||0.135|2-Sided|90.0|-2.18|0.44||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 2|
1590346|NCT03214588|2923700|Superiority||Least Squares Mean Difference|-0.00069|Standard Error of the Mean|0.000616|>|0.999|2-Sided|90.0|-0.00172|0.00033||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590347|NCT03214588|2923700|Superiority||Least Squares Mean Difference|-0.00054|Standard Error of the Mean|0.000746|>|0.999|2-Sided|90.0|-0.00179|0.0007||P-values are 1-sided, with the alternative hypothesis that TAK-831 is superior to placebo in the clinically favorable direction.|ANCOVA|||Change from Baseline at Week 12|
1590348|NCT03214380|2923712|Superiority||Mean Difference (Net)|-17.4|||<|0.001|2-Sided|95.0|-25.3|-9.5|||ANCOVA||||
1590349|NCT03214380|2923713|Superiority||Mean Difference (Net)|-11.8|||<|0.001|2-Sided|95.0|-18.1|-5.5|||ANCOVA||||
1590350|NCT03214380|2923714|Non-Inferiority|Non-inferiority Margin = 0.4 for HbA1c|Least Square Mean Difference (LSMean)|0.06|||||2-Sided|95.0|-0.05|0.16|||||||
1590351|NCT03214367|2923715|Superiority||LS Mean Difference|-0.06||||0.184|2-Sided|95.0|-0.16|0.03|||Mixed Models Analysis||||
1590352|NCT03214367|2923724|Superiority||LS Mean Difference|-6.7||||0.235|2-Sided|95.0|-17.6|4.3|||ANCOVA||||
1590353|NCT03214367|2923724|Superiority||LS Mean Difference|-31.2|||<|0.001|2-Sided|95.0|-41.1|-21.2|||ANCOVA||||
1590354|NCT03214367|2923725|Superiority||LS Mean Difference|13.2||||0.002|2-Sided|95.0|5.0|21.4|||ANCOVA||||
1590355|NCT03214367|2923725|Superiority||LS Mean Difference|-27.9|||<|0.001|2-Sided|95.0|-35.3|-20.6|||ANCOVA||||
1590356|NCT03214367|2923726|Non-Inferiority|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|0.13||||0.003|2-Sided|95.0|0.04|0.22|||Mixed Models Analysis||||
1590357|NCT03214367|2923726|Non-Inferiority|Noninferiority margin = 0.4% for HbA1c|LS Mean Difference|-0.08||||0.06|2-Sided|95.0|-0.16|0.0|||Mixed Models Analysis||||
1590358|NCT03213366|2923762|Superiority||Slope|0.03103||||0.0334|2-Sided||||||Mixed Models Analysis|||At 12 weeks.|
1590359|NCT03213366|2923762|Superiority||Slope|-0.0209||||0.0818|2-Sided||||||Mixed Models Analysis|||At 6 weeks.|
1590360|NCT03213366|2923763|Superiority||Slope|-0.05101||||0.133|2-Sided||||||Mixed Models Analysis|||At 12 weeks.|
1590361|NCT03213366|2923763|Superiority||Slope|-0.05747||||0.1021|2-Sided||||||Mixed Models Analysis|||At 6 weeks.|
1590362|NCT03213366|2923764|Superiority||Slope|0.03052||||0.0022|2-Sided||||||Mixed Models Analysis|||At 12 weeks.|
1590363|NCT03213366|2923764|Superiority||Slope|0.0278||||0.0124|2-Sided||||||Mixed Models Analysis|||At 6 weeks.|
1590364|NCT03213366|2923765|Superiority||Slope|-0.03149||||0.2141|2-Sided||||||Mixed Models Analysis|||At 12 weeks.|
1590365|NCT03213366|2923765|Superiority||Slope|-0.302||||0.2114|2-Sided||||||Mixed Models Analysis|||At 6 weeks.|
1590366|NCT03213366|2923766|Superiority||Slope|0.01358||||0.0839|2-Sided||||||Mixed Models Analysis|||At 12 weeks.|
1590367|NCT03213366|2923766|Superiority||Slope|0.008705||||0.2433|2-Sided|||||This t-test was for the random effects model not for comparing the difference between the arms.|Mixed Models Analysis||||
1590368|NCT03213366|2923767|Superiority||Slope|0.004308||||0.3229|2-Sided||||||Mixed Models Analysis|||At 12 weeks|
1590369|NCT03213366|2923767|Superiority||Slope|0.000443||||0.8963|2-Sided||||||Mixed Models Analysis|||At 6 weeks.|
1590370|NCT03213366|2923768|Superiority||Slope|0.02594||||0.1999|2-Sided|95.0|-0.01648|0.06836|||Mixed Models Analysis|||At 12 weeks.|
1590371|NCT03213366|2923768|Superiority||Slope|0.03674||||0.07863|2-Sided|95.0|-0.00516|0.07863|||Mixed Models Analysis|||At 6 weeks.|
1590372|NCT03213366|2923769|Superiority||Slope|-0.01692||||0.3185|2-Sided|95.0|-0.05318|0.01933|||Mixed Models Analysis|||At 12 weeks.|
1590373|NCT03213366|2923769|Superiority||Slope|-0.0095||||0.5783|2-Sided|95.0|-0.04676|0.02776|||Mixed Models Analysis|||At 6 weeks.|
1590374|NCT03212638|2923787|Equivalence|0.80, 1.25 as the bioequivalence boundaries|ratio|0.978|||||2-Sided|95.0|0.941|1.02||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.|
1590375|NCT03212638|2923787|Equivalence|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.999|||||2-Sided|95.0|0.966|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).|
1590376|NCT03212638|2923787|Equivalence|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.999|||||2-Sided|95.0|0.996|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).|
1590377|NCT03212638|2923788|Equivalence|0.80, 1.25 as the bioequivalence boundaries|ratio|0.973|||||2-Sided|95.0|0.936|1.01||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.|
1590378|NCT03212638|2923788|Equivalence|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.998|||||2-Sided|95.0|0.995|1.03||||||Bioequivalence of s single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).|
1590379|NCT03212638|2923788|Equivalence|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.996|||||2-Sided|95.0|0.963|1.03||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).|
1590380|NCT03212638|2923789|Equivalence|0.80, 1.25 as the bioequivalence boundaries|Ratio|0.675|||||2-Sided|95.0|0.617|0.74||||||Bioequivalence of single 4 mg dose of baricitinib as fasted vs fed.|
1590381|NCT03212638|2923789|Equivalence|0.80, 1.25 as the bioequivalence boundaries|ratio|1.04|||||2-Sided|95.0|0.944|1.14||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation without (T2) water compared to the commercial tablet (R).|
1590382|NCT03212638|2923789|Equivalence|0.80, 1.25 as the bioequivalence boundaries|Ratio|1.04|||||2-Sided|95.0|0.946|1.15||||||Bioequivalence of single 4 mg dose of baricitinib as the suspension formulation with (T1) water compared to the commercial tablet (R).|
1590436|NCT03207438|2923941|Superiority||Hazard Ratio (HR)|1.17|Standard Error of the Mean|0.1||0.14|2-Sided||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Interaction - treatment condition by melancholia|
1590740|NCT03187197|2924459|Other|||||||0.611|||||||t-test, 2 sided|||Between group comparison of Visit 3 treatment convenience before PSM.|
1590383|NCT03211858|2923811|Non-Inferiority|Non-inferiority of SAR341402 over NovoLog/NovoRapid was demonstrated if upper bound of the 2-sided 95% confidence interval (CI) of the difference between SAR341402 and NovoLog/NovoRapid was <0.3%. If non-inferiority was demonstrated, using a hierarchical step down testing procedure, the inverse non-inferiority of NovoLog/NovoRapid over SAR341402 was tested and was demonstrated if lower bound of the 2-sided 95% CI of the difference between SAR341402 and NovoLog/NovoRapid was > -0.3%.|LS Mean difference|-0.08|Standard Error of the Mean|0.059|||2-Sided|95.0|-0.192|0.039|||||SAR341402 vs Novolog/Novorapid|Analysis was performed using ANCOVA with treatment group (SAR341402, NovoLog/NovoRapid), the randomization strata of geographical region, type of diabetes and prior use of NovoLog/NovoRapid as fixed categorical effects, as well as the continuous fixed covariate of baseline HbA1c value.|
1590384|NCT03208673|2923910|Superiority||||||<|0.001|||||||t-test, 1 sided|||Vision|
1590385|NCT03208673|2923910|Superiority||||||<|0.001|||||||t-test, 1 sided|||Gritty|
1590386|NCT03208673|2923910|Superiority||||||<|0.001|||||||t-test, 1 sided|||Dry|
1590387|NCT03208673|2923910|Superiority||||||<|0.001|||||||t-test, 1 sided|||Comfort|
1590388|NCT03208673|2923911|Superiority|||||||0.312|||||||t-test, 1 sided|||Temporal|
1590389|NCT03208673|2923911|Superiority|||||||0.025|||||||t-test, 1 sided|||Nasal|
1590390|NCT03208673|2923912|Superiority||Ratio of Geometric mean|0.5628||||0.001|2-Sided|95.0|0.4395|0.7204|||t-test, 2 sided||||
1590391|NCT03207776|2923915|Superiority||Odds Ratio (OR)|1.14||||0.544|2-Sided|95.0|0.74|1.77|||Mixed Models Analysis||||
1590392|NCT03207776|2923916|Superiority||Odds Ratio (OR)|0.91||||0.472|2-Sided|95.0|0.71|1.17|||Mixed Models Analysis||||
1590393|NCT03207776|2923917|Superiority||Odds Ratio (OR)|0.99||||0.952|2-Sided|95.0|0.69|1.42|||Mixed Models Analysis||||
1590394|NCT03207776|2923918|Superiority||Odds Ratio (OR)|0.8||||0.041|2-Sided|95.0|0.64|0.99|||Mixed Models Analysis||||
1590395|NCT03207750|2923930|Other|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be <=0.025 for PRN antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 & the posterior probability of the cut-off in HRV Lyophilized group||To rule out 10% decrease in seroresponse to PRN antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.|
1590396|NCT03207750|2923930|Other|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be <=0.025 for FHA antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 & the posterior probability of the cut-off in HRV lyophilized group||To rule out 10% decrease in seroresponse to FHA antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.|
1590397|NCT03207750|2923930|Other|p-value on the difference in seroresponse (HRV PCV-free Liquid group minus HRV Lyophilized group) between groups should be <=0.025 for PT antigen.|||||<|0.0001|||||||t-test, 1 sided|p-value was computed by integrating on p-values of 1 sided test with alpha=0.025 & the posterior probability of the cut-off in HRV Lyophilized group||To rule out 10% decrease in seroresponse to PT antigen in subjects who received Pediarix co-administered with PCV-free-Liquid-HRV vaccine compared to subjects who received Pediarix co-administered with currently licensed lyophilized HRV vaccine where seroresponse was defined as percentage of subjects who showed a concentration above a threshold that led to 95% seroresponse in HRV lyophilized group.|
1590398|NCT03207750|2923931|Non-Inferiority|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-10%.|Difference in anti-PRP concentration|-0.88|||||2-Sided|95.0|-5.75|3.99||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 1.0 µg/mL) of anti-PRP antibodies.|
1590399|NCT03207750|2923932|Non-Inferiority|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentrations (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-PRP antibodies should be ≥-5%.|Difference in anti-PRP concentration|0.17|||||2-Sided|95.0|-1.94|2.28||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with concentrations (≥ 0.15 µg/mL) of anti-PRP antibodies.|
1590400|NCT03207750|2923933|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 23F should be ≥ 0.5.|GMC ratio|0.98|||||2-Sided|95.0|0.87|1.1||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 23F.|
1590401|NCT03207750|2923933|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19F should be ≥ 0.5.|GMC ratio|1.03|||||2-Sided|95.0|0.95|1.12||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19F.|
1590402|NCT03207750|2923933|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 19A should be ≥ 0.5.|GMC ratio|1.04|||||2-Sided|95.0|0.93|1.15||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 19A.|
1590403|NCT03207750|2923933|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 18C should be ≥ 0.5.|GMC ratio|1.03|||||2-Sided|95.0|0.92|1.14||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 18C.|
1590404|NCT03207750|2923933|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 14 should be ≥ 0.5.|GMC ratio|1.0|||||2-Sided|95.0|0.89|1.13||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 14.|
1590405|NCT03207750|2923933|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 9V should be ≥ 0.5.|GMC ratio|1.03|||||2-Sided|95.0|0.93|1.14||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 9V.|
1590406|NCT03207750|2923933|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 7F should be ≥ 0.5.|GMC ratio|0.99|||||2-Sided|95.0|0.91|1.08||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 7F.|
1590407|NCT03207750|2923933|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6B should be ≥ 0.5.|GMC ratio|0.96|||||2-Sided|95.0|0.83|1.12||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6B.|
1590408|NCT03207750|2923933|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 6A should be ≥ 0.5.|GMC ratio|1.01|||||2-Sided|95.0|0.92|1.12||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 6A.|
1590409|NCT03207750|2923933|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 5 should be ≥ 0.5.|GMC ratio|1.05|||||2-Sided|95.0|0.94|1.17||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 5.|
1590410|NCT03207750|2923933|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 4 should be ≥ 0.5.|GMC ratio|0.99|||||2-Sided|95.0|0.9|1.09||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 4.|
1590411|NCT03207750|2923933|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 3 should be ≥ 0.5.|GMC ratio|1.0|||||2-Sided|95.0|0.91|1.11||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 3.|
1590412|NCT03207750|2923933|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for S. pneumoniae serotype 1 should be ≥ 0.5.|GMC ratio|1.03|||||2-Sided|95.0|0.93|1.14||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for Streptococcus pneumoniae (S. pneumoniae) serotype 1.|
1590413|NCT03207750|2923934|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PRN antibodies should be ≥ 0.67.|GMC ratio|0.97|||||2-Sided|95.0|0.86|1.1||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PRN antibodies.|
1590414|NCT03207750|2923934|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-FHA antibodies should be ≥ 0.67.|GMC ratio|1.0|||||2-Sided|95.0|0.92|1.08||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-FHA antibodies.|
1590415|NCT03207750|2923934|Non-Inferiority|Lower limit (LL) of the two-sided 95% CI on GMC ratios (HRV PCV-free Liquid group over HRV Lyophilized group) for each of anti-PT antibodies should be ≥ 0.67.|GMC ratio|0.94|||||2-Sided|95.0|0.86|1.03||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of GMC ratios for anti-PT antibodies.|
1590437|NCT03207438|2923941|Superiority||Hazard Ratio (HR)|1.46|Standard Error of the Mean|0.06|<|0.001|2-Sided||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Main effect of quetiapine vs. placebo|
1590438|NCT03207438|2923941|Superiority||Hazard Ratio (HR)|1.15|Standard Error of the Mean|0.1|<|0.18|2-Sided||||||Regression, Cox|||Interaction - treatment condition x melancholia|
1590416|NCT03207750|2923935|Non-Inferiority|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 3 antibodies should be ≥-5%.|Difference in anti-polio 3 concentration|0.0|||||2-Sided|95.0|-0.87|0.84||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 3 antibodies.|
1590417|NCT03207750|2923935|Non-Inferiority|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 2 antibodies should be ≥-5%.|Difference in anti-polio 2 concentration|-0.01|||||2-Sided|95.0|-1.02|0.98||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 2 antibodies.|
1590418|NCT03207750|2923935|Non-Inferiority|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-poliovirus type 1 antibodies should be ≥-5%.|Difference in anti-polio 1 concentration|0.21|||||2-Sided|95.0|-0.6|1.15||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective titers (≥ 8 ED50) of anti-poliovirus type 1 antibodies.|
1590419|NCT03207750|2923936|Non-Inferiority|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-HB antibodies should be ≥-10%.|Difference in anti-HB concentration|-0.65|||||2-Sided|95.0|-1.9|0.16||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 10 mIU/mL) of anti-HB antibodies.|
1590420|NCT03207750|2923937|Non-Inferiority|Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-T antibodies should be ≥-10%.|Difference in anti-T concentration|0.0|||||2-Sided|95.0|-0.79|0.77||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-T antibodies.|
1590421|NCT03207750|2923937|Non-Inferiority|Lower limit (LL) of the two-sided asymptotic standardized 95% Confidence Interval (CI) for the difference in seroprotective concentration (HRV PCV-free Liquid group minus HRV Lyophilized group) for each of anti-D antibodies should be ≥-10%.|Difference in anti-D concentration|0.0|||||2-Sided|95.0|-0.8|0.79||||||Non-inferiority of the immune responses to 3 doses of Pediarix, Hiberix and Prevenar 13 when co-administered with 2 doses of the PCV-free liquid HRV vaccine, as compared to when co-administered with lyophilized HRV vaccine in terms of group difference in percentage of subjects with seroprotective concentrations (≥ 0.1 IU/mL) of anti-D antibodies.|
1590422|NCT03207438|2923938|Superiority||Chi-squared|2.45||||0.059|2-Sided||||||Chi-squared, Corrected|||Week 6 - chi-squared test comparing response rates between groups.|
1590423|NCT03207438|2923938|Superiority||Chi-squared|0.62||||0.22|2-Sided||||||Chi-squared, Corrected|||Week 4 - chi-squared test comparing response rates between groups.|
1590424|NCT03207438|2923938|Superiority||Chi-squared|3.87||||0.02|2-Sided||||||Chi-squared, Corrected|||Week 2 - chi-squared test comparing response rates between groups.|
1590425|NCT03207438|2923938|Superiority||Chi-squared|3.3||||0.03|2-Sided||||||Chi-squared, Corrected|||Week 1 - chi-squared test comparing response rates between groups.|
1590426|NCT03207438|2923938|Superiority||Chi-squared|0.001||||0.5|2-Sided||||||Chi-squared, Corrected||Estimated chi-squared statistic was 1.88(10^-29).|Day 4 - chi-squared test comparing response rates between groups.|
1590427|NCT03207438|2923939|Superiority||Chi-squared|0.001||||0.5|2-Sided||||||Chi-squared, Corrected||The actual estimated Chi-squared statistic was 6.35(10^-31)|Week 6 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup|
1590428|NCT03207438|2923939|Superiority||Chi-squared|1.5||||0.11|2-Sided||||||Chi-squared, Corrected|||Week 4 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup|
1590429|NCT03207438|2923939|Superiority||Chi-squared|0.38||||0.73|2-Sided||||||Chi-squared, Corrected|||Week 2 - Chi-squared test comparing the proportion of quetiapine responders in each sleep subgroup|
1590430|NCT03207438|2923939|Superiority||Odds Ratio (OR)|1.3||||0.44|2-Sided||||||Fisher's exact test||The exact limits of 95% confidence interval could not be estimated, it was reported as 0.40 to infinity.|Week 1 - Fisher's exact test comparing the proportion of quetiapine responders in each sleep subgroup|
1590431|NCT03207438|2923939|Superiority|||||||0.33|||||||Fisher's exact test|||Day 4 - Fisher's exact test comparing the proportion of quetiapine responders in each sleep subgroup|An exact OR could not be estimated by R; the 95% confidence interval was 0.31 to infinity, p = .33.
1590432|NCT03207438|2923940|Superiority||Hazard Ratio (HR)|1.18|Standard Error of the Mean|0.11||0.13|2-Sided||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Interaction - treatment condition by melancholia|
1590433|NCT03207438|2923940|Superiority||Hazard Ratio (HR)|1.3|Standard Error of the Mean|0.06|<|0.001|2-Sided||||||Regression, Cox|Adjusted for baseline depression severity, Study number (1-4), and melancholic-by-time interaction.||Main effect of quetiapine vs. placebo|
1590434|NCT03207438|2923940|Superiority||Hazard Ratio (HR)|1.16|Standard Error of the Mean|0.11|<|0.17|2-Sided||||||Regression, Cox|||Interaction - treatment condition x melancholia|
1590435|NCT03207438|2923940|Superiority||Hazard Ratio (HR)|1.35|Standard Error of the Mean|0.06|<|0.001|2-Sided||||||Regression, Cox|||Main effect of quetiapine vs. placebo|
1599054|NCT02858401|2938157|Other|||||||1|||||||Fisher Exact||||
1590439|NCT03207438|2923941|Superiority||Hazard Ratio (HR)|1.39|Standard Error of the Mean|0.06|<|0.001|2-Sided||||||Regression, Cox|||Main effect of quetiapine vs. placebo|
1590440|NCT03207243|2923951|Other||Percent change|2663.0|||<|0.001|2-Sided|95.0|1994.6|3544.8||Week 16|mixed model repeated measures analysis||||
1590441|NCT03207243|2923951|Other||Percent change|2162.2|||<|0.001|2-Sided|95.0|1489.1|3120.3||Week 12|mixed model repeated measures analysis||||
1590442|NCT03207243|2923951|Other||Percent change|2507.7|||<|0.001|2-Sided|95.0|1924.2|3259.4||Week 8|mixed model repeated measures analysis||||
1590443|NCT03207243|2923951|Other||Percent change|2300.4|||<|0.001|2-Sided|95.0|1833.9|2879.3||Week 4|mixed model repeated measures analysis||||
1590444|NCT03207243|2923952|Other||Percent change|-93.3|||<|0.001|2-Sided|95.0|-95.3|-90.4||Week 16|mixed model repeated measures analysis||||
1590445|NCT03207243|2923952|Other||Percent change|-93.2|||<|0.001|2-Sided|95.0|-95.4|-90.0||Week 12|mixed model repeated measures analysis||||
1590446|NCT03207243|2923952|Other||Percent change|-92.9|||<|0.001|2-Sided|95.0|-94.8|-90.3||Week 8|mixed model repeated measures analysis||||
1590447|NCT03207243|2923952|Other||Percent change|-93.4|||<|0.001|2-Sided|95.0|-94.9|-91.7||Week 4|mixed model repeated measures analysis||||
1590448|NCT03207243|2923996|Other|||||||0.044|||||||Log Rank||||
1590449|NCT03207243|2923997|Other||Median Rate Ratio|0.71|||||2-Sided|95.0|0.44|1.01|||||Median rate ratio (Placebo - GSK3772847) and its 95% Credible Interval has been presented||
1590450|NCT03207243|2924002|Other||Median Rate Ratio|0.82|||||2-Sided|95.0|0.66|0.99|||||Median rate ratio (Placebo - GSK3772847) and its 95% Credible Interval has been presented||
1590451|NCT03206970|2924010|Other||Clopper-Pearson|83.7|||<|0.0001|2-Sided|95.0|74.2|90.8|||Binomial Exact Test|||A binomial exact test was performed to test against the null hypothesis H0: ORR=0.40 using the significant level of 0.025 (1-sided)|
1590452|NCT03205163|2924013|Other||GMR|4.46|||<|0.001|2-Sided|95.0|4.16|4.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590453|NCT03205163|2924014|Other||GMR|4.57|||<|0.001|2-Sided|95.0|4.0|5.23|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590454|NCT03205163|2924015|Other||GMR|1.18|||<|0.001|2-Sided|95.0|1.1|1.26|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590455|NCT03205163|2924016|Other||GMR|1.36||||0.063|2-Sided|95.0|0.978|1.89|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590456|NCT03205163|2924017|Other||GMR|4.32|||<|0.001|2-Sided|95.0|3.96|4.72|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590457|NCT03205163|2924018|Other||GMR|4.54|||<|0.001|2-Sided|95.0|3.64|5.66|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590458|NCT03205163|2924019|Other||GMR|6.54|||<|0.001|2-Sided|95.0|5.89|7.27|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590459|NCT03205163|2924020|Other||GMR|7.0|||<|0.001|2-Sided|95.0|5.78|8.48|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590460|NCT03205163|2924021|Other||GMR|0.599|||<|0.001|2-Sided|95.0|0.525|0.684|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590461|NCT03205163|2924022|Other||GMR|0.622||||0.003|2-Sided|95.0|0.492|0.786|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590462|NCT03205163|2924023|Other||GMR|0.153|||<|0.001|2-Sided|95.0|0.138|0.17|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590463|NCT03205163|2924024|Other||GMR|0.143|||<|0.001|2-Sided|95.0|0.118|0.172|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590741|NCT03187197|2924459|Other|||||||0.7879|||||||t-test, 2 sided|||Between group comparison of Visit 2 treatment convenience before PSM.|
1590464|NCT03205163|2924025|Other||GMR|3.24|||<|0.001|2-Sided|95.0|2.76|3.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590465|NCT03205163|2924026|Other||GMR|4.13|||<|0.001|2-Sided|95.0|2.94|5.79|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590466|NCT03205163|2924027|Other||GMR|1.17|||<|0.001|2-Sided|95.0|1.09|1.25|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an ANOVA model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and GMR were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590467|NCT03205163|2924028|Other||GMR|1.35||||0.032|2-Sided|95.0|1.04|1.77|||ANOVA|||Comparison of Advate and BIVV001 was obtained through analyzing log transformed PK parameters using an analysis of variance (ANOVA) model containing participant and treatment as factors. Geometric mean, 95% confidence interval of geometric mean, and geometric mean ratio (GMR) were the exponentiated mean, 95% confidence interval, and difference of means, respectively.|
1590468|NCT03204643|2924034|Superiority||Odds Ratio (OR)|1.35||||0.08|2-Sided|0.96|0.96|1.9|||Mixed Models Analysis||||
1590469|NCT03204643|2924035|Superiority||Odds Ratio (OR)|1.16||||0.62|2-Sided|95.0|0.65|2.08|||Mixed Models Analysis||||
1590470|NCT03204643|2924036|Superiority||Odds Ratio (OR)|1.07||||0.76|2-Sided|95.0|0.7|1.64|||Mixed Models Analysis||||
1590471|NCT03204643|2924037|Superiority||Odds Ratio (OR)|0.74||||0.06|2-Sided|95.0|0.54|1.02|||Regression, Logistic||||
1590472|NCT03203564|2924072|Other||Mean Difference (Final Values)|7.4|||||2-Sided|90.0|0.68|14.12|||||Parameter estimate is done for Placebo-corrected change-from baseline QTcF (ΔΔQTcF) for Modufolin 500 mg/m2 at end of infusion.|The primary analysis of QTcF was based on a linear mixed-effects model with change-from-baseline QTcF as the dependent variable, time (categorical), treatment, and time-by-treatment interaction as fixed effects, and baseline QTcF as a covariate. The least-squares (LS) mean and 2-sided 90 % CIs have been calculated for the contrast “Modufolin® versus placebo” at each dose of Modufolin® and each post-dose time point.|
1590473|NCT03200912|2924101|Equivalence|Primary Efficacy Endpoint - AK Complete Clearance Rates at Day 57 (PP and mITT Populations)|Mean Difference (Net)|2.29|||||2-Sided|90.0|-7.55|12.14|||||||
1590474|NCT03200860|2924104|Superiority|||||||0.014|||||||Regression, Logistic||||
1590475|NCT03200860|2924105|Superiority|||||||0.31|||||||Regression, Logistic||||
1590476|NCT03200860|2924106|Superiority|||||||0.63|||||||t-test, 2 sided||||
1590477|NCT03200860|2924107|Superiority|||||||0.58|||||||Wilcoxon (Mann-Whitney)||||
1590478|NCT03200860|2924108|Superiority|||||||0.37|||||||t-test, 2 sided||||
1590479|NCT03200860|2924109|Superiority|||||||0.18|||||||t-test, 2 sided||||
1590480|NCT03200535|2924110|Superiority||||||<|0.001|||||||Chi-squared||||
1590481|NCT03200535|2924111|Superiority|Superiority analysis|||||<|0.001|||||||Chi-squared||||
1590482|NCT03198767|2924116|Superiority||Median Difference (Final Values)|0.18||||0.452|2-Sided|80.0|-0.13|0.49|||Mixed Models Analysis||||
1590483|NCT03198767|2924116|Superiority||Median Difference (Final Values)|-0.19||||0.436|2-Sided|80.0|-0.5|0.12|||Mixed Models Analysis||||
1590484|NCT03198767|2924116|Superiority||Mean Difference (Final Values)|-0.37||||0.135|2-Sided|80.0|-0.68|-0.05|||Mixed Models Analysis||||
1590485|NCT03198767|2924116|Superiority||Mean Difference (Final Values)|-0.85||||0.009|2-Sided|80.0|-1.25|-0.45|||Mixed Models Analysis||||
1590486|NCT03198767|2924116|Superiority||Median Difference (Final Values)|-1.06||||0.001|2-Sided|80.0|-1.46|-0.67|||Mixed Models Analysis||||
1590487|NCT03198767|2924116|Superiority||Mean Difference (Final Values)|-0.21||||0.426|2-Sided|80.0|-0.56|0.13|||Mixed Models Analysis||||
1590488|NCT03198767|2924117|Superiority||Ratio of number of events|1.14||||0.401|2-Sided|80.0|0.93|1.41|||Mixed Models Analysis||||
1590489|NCT03198767|2924117|Superiority||Ratio of number of events|0.9||||0.51|2-Sided|80.0|0.74|1.1|||Mixed Models Analysis||||
1590490|NCT03198767|2924117|Superiority||Ratio of number of events|0.79||||0.141|2-Sided|80.0|0.65|0.97|||Mixed Models Analysis||||
1590491|NCT03198767|2924117|Superiority||Ratio of number of events|0.54||||0.008|2-Sided|80.0|0.41|0.72|||Mixed Models Analysis||||
1590492|NCT03198767|2924117|Superiority||Ratio of number of events|0.37|||<|0.001|2-Sided|80.0|0.28|0.49|||Mixed Models Analysis||||
1590493|NCT03198767|2924117|Superiority||Ratio of number of events|0.68|||<|0.04|2-Sided|80.0|0.54|0.86|||Mixed Models Analysis||||
1590494|NCT03198767|2924118|Superiority||Ratio of number of events|0.98||||0.921|2-Sided|80.0|0.73|1.3|||Mixed Models Analysis|||Day 3|
1590495|NCT03198767|2924118|Superiority||Ratio of number of events|0.78||||0.234|2-Sided|80.0|0.59|1.02|||Mixed Models Analysis|||Day 3|
1590496|NCT03198767|2924118|Superiority||Ratio of number of events|0.79||||0.275|2-Sided|80.0|0.6|1.04|||Mixed Models Analysis|||Day 3|
1590497|NCT03198767|2924118|Superiority||Ratio of number of events|0.3|||<|0.001|2-Sided|80.0|0.19|0.46|||Mixed Models Analysis|||Day 3|
1590498|NCT03198767|2924118|Superiority||Ratio of number of events|0.21|||<|0.001|2-Sided|80.0|0.14|0.32|||Mixed Models Analysis|||Day 3|
1590499|NCT03198767|2924118|Superiority||Ratio of number of events|0.71|||<|0.202|2-Sided|80.0|0.5|1.0|||Mixed Models Analysis|||Day 3|
1590500|NCT03198507|2924119|Superiority|||||||0.0001|||||||t-test, 2 sided||||
1590501|NCT03198507|2924122|Superiority|||||||0.0001||||||Statistical testing was 2 sided and performed using a significance (alpha) level of 0.05.|t-test, 2 sided||||
1590502|NCT03198000|2924149|Equivalence|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.17||0.233|2-Sided|95.0|-0.54|0.13|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.|||
1590503|NCT03198000|2924149|Equivalence|No equivalence interval was specified.|Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.17||0.398|2-Sided|95.0|-0.48|0.19|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.|||
1590504|NCT03198000|2924150|Equivalence|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.17||0.234|2-Sided|95.0|-0.55|0.14|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.|||
1590505|NCT03198000|2924150|Equivalence|No equivalence interval was specified.|Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.18||0.162|2-Sided|95.0|-0.6|0.1|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.|||
1590506|NCT03198000|2924151|Equivalence|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.21||0.269|2-Sided|95.0|-0.18|0.64|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.|||
1590507|NCT03198000|2924151|Equivalence|No equivalence interval was specified.|Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.21||0.085|2-Sided|95.0|-0.05|0.78|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.|||
1590508|NCT03198000|2924153|Equivalence|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.049||0.255|2-Sided|95.0|-0.153|0.041|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.|||
1590509|NCT03198000|2924153|Equivalence|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.05||0.117|2-Sided|95.0|-0.177|0.02|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.|||
1590510|NCT03198000|2924154|Equivalence|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.04||0.886|2-Sided|95.0|-0.073|0.084|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.|||
1590511|NCT03198000|2924154|Equivalence|No equivalence interval was specified for this time point.|Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.04||0.893|2-Sided|95.0|-0.085|0.074|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.|||
1590512|NCT03198000|2924155|Equivalence|Prespecified equivalence interval of (0.80, 1.25)|Odds Ratio (OR)|0.87||||0.544|2-Sided|95.0|0.552|1.368|||GEE model|GEE model with treatment as factor.|||
1590513|NCT03198000|2924155|Equivalence|Prespecified equivalence interval of (0.80, 1.25).|Odds Ratio (OR)|0.87||||0.576|2-Sided|95.0|0.539|1.411|||GEE model|GEE model with treatment as factor.|||
1590514|NCT03198000|2924156|Equivalence|Prespecified equivalence interval of (-0.22, 0.44)|Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.049||0.828|2-Sided|95.0|-0.086|0.107|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.|||
1590515|NCT03198000|2924156|Equivalence|Prespecified equivalence interval of (-0.22, 0.44).|Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.049||0.392|2-Sided|95.0|-0.14|0.055|||ANCOVA|Mixed effect ANCOVA with treatment as factor and baseline value as a covariate.|||
1590516|NCT03197558|2924170|Superiority|Upper confidence limit of mean VAS score hypothesized to be less than (superior) to a performance goal of 45 mm.|Bootstrap method|14.35|||||1-Sided|97.5||14.35||||||Mean VAS score compared to performance goal using a bootstrap method test at 2.5% significance.|
1590517|NCT03197376|2924171|Non-Inferiority|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of < 0.10.|Absolute difference for yellow fever|2.4|||||2-Sided|95.0|0.2|5.9|||||||
1590518|NCT03197376|2924171|Non-Inferiority|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of < 0.10.|Absolute difference for rubella|1.0|||||2-Sided|95.0|-0.9|4.0|||||||
1590519|NCT03197376|2924171|Non-Inferiority|Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of < 0.10.|Absolute difference for measles|1.7|||||2-Sided|95.0|-3.3|7.4|||||||
1590520|NCT03197376|2924172|Other|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 23F|3.14|||||2-Sided|95.0|2.21|4.45|||||||
1590521|NCT03197376|2924172|Other|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 19F|1.01|||||2-Sided|95.0|0.7|1.46|||||||
1590522|NCT03197376|2924172|Other|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 19A|12.54|||||2-Sided|95.0|7.36|21.37|||||||
1590523|NCT03197376|2924172|Other|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 14|2.21|||||2-Sided|95.0|1.38|3.51|||||||
1590524|NCT03197376|2924172|Other|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 9V|0.93|||||2-Sided|95.0|0.65|1.32|||||||
1590525|NCT03197376|2924172|Other|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 7F|1.73|||||2-Sided|95.0|1.28|2.34|||||||
1590526|NCT03197376|2924172|Other|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 6B|1.75|||||2-Sided|95.0|1.25|2.46|||||||
1590742|NCT03187197|2924460|Other|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline satisfaction with that of Visit 3.|
1590527|NCT03197376|2924172|Other|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 6A|68.1|||||2-Sided|95.0|37.07|125.09|||||||
1590528|NCT03197376|2924172|Other|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 5|1.14|||||2-Sided|95.0|0.79|1.64|||||||
1590529|NCT03197376|2924172|Other|The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|OPA GMT Ratio-Type 1|1.84|||||2-Sided|95.0|1.25|2.72|||||||
1590530|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 23F|5.73|||||2-Sided|95.0|3.8|8.63|||||||
1590531|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19F|1.97|||||2-Sided|95.0|1.45|2.68|||||||
1590532|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19A|5.98|||||2-Sided|95.0|3.88|9.21|||||||
1590533|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 14|1.62|||||2-Sided|95.0|1.06|2.46|||||||
1590534|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 9V|2.95|||||2-Sided|95.0|2.15|4.04|||||||
1590535|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 7F|2.81|||||2-Sided|95.0|2.13|3.69|||||||
1590536|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6B|3.25|||||2-Sided|95.0|2.25|4.7|||||||
1590537|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6A|6.21|||||2-Sided|95.0|3.55|10.84|||||||
1590538|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 5|3.19|||||2-Sided|95.0|2.56|3.98|||||||
1590539|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 1|6.29|||||2-Sided|95.0|4.97|7.96|||||||
1590540|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 23F|4.97|||||2-Sided|95.0|3.49|7.06|||||||
1590541|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19F|2.38|||||2-Sided|95.0|1.8|3.14|||||||
1590542|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 19A|3.64|||||2-Sided|95.0|2.47|5.36|||||||
1590543|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 14|2.45|||||2-Sided|95.0|1.64|3.65|||||||
1590544|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 9V|6.85|||||2-Sided|95.0|4.45|10.52|||||||
1590545|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 7F|3.89|||||2-Sided|95.0|2.92|5.18|||||||
1590546|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6B|3.76|||||2-Sided|95.0|2.48|5.69|||||||
1590547|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 6A|2.5|||||2-Sided|95.0|1.83|3.42|||||||
1590548|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 5|2.54|||||2-Sided|95.0|2.06|3.13|||||||
1590549|NCT03197376|2924173|Other|The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points|OPA GMT Ratio-Type 1|3.47|||||2-Sided|95.0|2.72|4.44|||||||
1591012|NCT03161938|2925187|Superiority|||||||0.703|||||||Chi-squared, Corrected|||Day 0, fatigue|
1590550|NCT03197376|2924174|Other|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 23F GMC Ratio|1.91|||||2-Sided|95.0|1.63|2.24|||||||
1590551|NCT03197376|2924174|Other|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 19F GMC Ratio|0.63|||||2-Sided|95.0|0.55|0.73|||||||
1590552|NCT03197376|2924174|Other|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 19A GMC Ratio|4.22|||||2-Sided|95.0|3.52|5.06|||||||
1590553|NCT03197376|2924174|Other|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 14 GMC Ratio|1.48|||||2-Sided|95.0|1.21|1.82|||||||
1590554|NCT03197376|2924174|Other|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 9V GMC Ratio|0.87|||||2-Sided|95.0|0.76|0.99|||||||
1590555|NCT03197376|2924174|Other|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 7F GMC Ratio|1.57|||||2-Sided|95.0|1.37|1.8|||||||
1590556|NCT03197376|2924174|Other|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 6B GMC Ratio|1.89|||||2-Sided|95.0|1.65|2.15|||||||
1590557|NCT03197376|2924174|Other|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 6A GMC Ratio|11.6|||||2-Sided|95.0|9.67|14.0|||||||
1590558|NCT03197376|2924174|Other|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 5 GMC Ratio|1.57|||||2-Sided|95.0|1.38|1.79|||||||
1590559|NCT03197376|2924174|Other|The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models|Pn IgG type 1 GMC Ratio|2.34|||||2-Sided|95.0|2.02|2.71|||||||
1590560|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 23F GMC Ratio|2.29|||||2-Sided|95.0|1.98|2.65|||||||
1590561|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19F GMC Ratio|1.55|||||2-Sided|95.0|1.38|1.75|||||||
1590562|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19A GMC Ratio|3.6|||||2-Sided|95.0|2.99|4.33|||||||
1590563|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 14 GMC Ratio|1.21|||||2-Sided|95.0|1.03|1.42|||||||
1590564|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 9V GMC Ratio|1.46|||||2-Sided|95.0|1.31|1.62|||||||
1590565|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 7F GMC Ratio|1.63|||||2-Sided|95.0|1.47|1.82|||||||
1590566|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6B GMC Ratio|3.85|||||2-Sided|95.0|3.23|4.59|||||||
1590567|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6A GMC Ratio|3.49|||||2-Sided|95.0|2.97|4.11|||||||
1590568|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 5 GMC Ratio|0.67|||||2-Sided|95.0|0.61|0.74|||||||
1590569|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 1 GMC Ratio|1.17|||||2-Sided|95.0|1.06|1.28|||||||
1590570|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 23F GMC Ratio|2.5|||||2-Sided|95.0|2.29|2.72|||||||
1590571|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19F GMC Ratio|1.49|||||2-Sided|95.0|1.36|1.63|||||||
1590572|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 19A GMC Ratio|2.64|||||2-Sided|95.0|2.4|2.91|||||||
1590743|NCT03187197|2924460|Other|||||||0.0031|||||||Paired t-test|||Within group comparison of Baseline satisfaction with that of Visit 2.|
1599055|NCT02858401|2938157|Other|||||||1|||||||Fisher Exact||||
1590573|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 14 GMC Ratio|1.35|||||2-Sided|95.0|1.21|1.51|||||||
1590574|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 9V GMC Ratio|1.39|||||2-Sided|95.0|1.29|1.5|||||||
1590575|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 7F GMC Ratio|2.04|||||2-Sided|95.0|1.89|2.19|||||||
1590576|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6B GMC Ratio|6.43|||||2-Sided|95.0|5.7|7.26|||||||
1590577|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 6A GMC Ratio|4.46|||||2-Sided|95.0|4.01|4.96|||||||
1590578|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 5 GMC Ratio|0.88|||||2-Sided|95.0|0.81|0.95|||||||
1590579|NCT03197376|2924175|Other|The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points.|Pn IgG type 1 GMC Ratio|1.41|||||2-Sided|95.0|1.31|1.52|||||||
1590580|NCT03197376|2924176|Other|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 23F|3.03|||||2-Sided|95.0|2.25|4.09|||||||
1590581|NCT03197376|2924176|Other|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 19F|0.66|||||2-Sided|95.0|0.54|0.81|||||||
1590582|NCT03197376|2924176|Other|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 19A|13.4|||||2-Sided|95.0|10.2|17.7|||||||
1590583|NCT03197376|2924176|Other|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 14|0.92|||||2-Sided|95.0|0.67|1.27|||||||
1590584|NCT03197376|2924176|Other|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 9V|0.38|||||2-Sided|95.0|0.29|0.49|||||||
1590585|NCT03197376|2924176|Other|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 7F|1.16|||||2-Sided|95.0|0.96|1.39|||||||
1590586|NCT03197376|2924176|Other|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 6B|1.95|||||2-Sided|95.0|1.42|2.69|||||||
1590587|NCT03197376|2924176|Other|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 6A|186.0|||||2-Sided|95.0|144.0|241.0|||||||
1590588|NCT03197376|2924176|Other|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 5|1.39|||||2-Sided|95.0|1.12|1.72|||||||
1590589|NCT03197376|2924176|Other|Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio)|OPA GMT Ratio-Type 1|3.09|||||2-Sided|95.0|2.4|3.98|||||||
1590590|NCT03197376|2924177|Other|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 23F|0.0|||||2-Sided||||||||CI could not be computed due to 100% response rate||
1590591|NCT03197376|2924177|Other|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 19F|-1.6|||||2-Sided|95.0|-4.9|1.2|||||||
1590592|NCT03197376|2924177|Other|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 19A|53.3|||||2-Sided|95.0|46.0|60.1|||||||
1590593|NCT03197376|2924177|Other|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type14|-0.8|||||2-Sided|95.0|-4.0|2.2|||||||
1590594|NCT03197376|2924177|Other|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 9V|0.0|||||2-Sided||||||||CI could not be computed due to 100% response rate||
1590595|NCT03197376|2924177|Other|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 7F|0.4|||||2-Sided|95.0|-1.1|2.2|||||||
1590596|NCT03197376|2924177|Other|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 6B|9.4|||||2-Sided|95.0|4.5|14.6|||||||
1590597|NCT03197376|2924177|Other|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 6A|82.2|||||2-Sided|95.0|76.7|86.6|||||||
1590598|NCT03197376|2924177|Other|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 5|2.8|||||2-Sided|95.0|0.0|6.2|||||||
1590599|NCT03197376|2924177|Other|Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes|OPA Type 1|17.2|||||2-Sided|95.0|11.0|23.6|||||||
1590622|NCT03197376|2924189|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 5 GMC Ratio|1.37|||||2-Sided|97.5|1.28|1.47|||||||
1590600|NCT03197376|2924178|Superiority|For each of the two serotypes, GMCs are compared by a two-sample t-test on the difference between means of log10 (antibody). The test was done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, are also be reported|Pn IgG type 19A GMC Ratio|5.64|||||2-Sided|97.5|5.14|6.18|||||||
1590601|NCT03197376|2924178|Superiority|For each of the two serotypes, GMCs are compared by a two-sample t-test on the difference between means of log10 (antibody). The test was done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, are also be reported|Pn IgG type 6A GMC Ratio|8.51|||||2-Sided|97.5|7.68|9.43|||||||
1590602|NCT03197376|2924179|Superiority|Proportions with IgG concentration ≥ 0.35 µg/mL will be compared using a z-test for proportions. The test will be done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, will also be reported|Difference for Type 19A|54.7|||||2-Sided|97.5|50.3|58.9|||||||
1590603|NCT03197376|2924179|Superiority|Proportions with IgG concentration ≥ 0.35 µg/mL will be compared using a z-test for proportions. The test will be done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, will also be reported|Difference for Type 6A|73.3|||||2-Sided|97.5|69.8|76.3|||||||
1590604|NCT03197376|2924186|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 95% CI for the GMC ratio exceeded 0.5 (for pertussis antigens).|GMC Ratio for anti-fimbriae 2/3|0.98|||||2-Sided|95.0|0.77|1.25|||||||
1590605|NCT03197376|2924187|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 95% CI for the GMC ratio exceeded 0.5 (for pertussis antigens).|GMC Ratio for anti-pertussis toxoid|0.82|||||2-Sided|95.0|0.62|1.09|||||||
1590606|NCT03197376|2924188|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Rotavirus|0.2|||||2-Sided|95.0|-7.1|7.1|||||||
1590607|NCT03197376|2924188|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 3|-0.9|||||2-Sided|95.0|-3.0|1.8|||||||
1590608|NCT03197376|2924188|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 2|2.8|||||2-Sided|95.0|-3.2|9.3|||||||
1590609|NCT03197376|2924188|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Polio type 1|-0.2|||||2-Sided|95.0|-1.3|1.5|||||||
1590610|NCT03197376|2924188|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Hib|-0.9|||||2-Sided|95.0|-2.5|1.2|||||||
1590611|NCT03197376|2924188|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Hepatitis B|0.4|||||2-Sided|95.0|-0.4|2.5|||||||
1590612|NCT03197376|2924188|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for Tetanus|0.0|||||2-Sided||||||||CI could not be computed due to 100% response rate||
1590613|NCT03197376|2924188|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix)|Absolute difference for diphtheria|0.0|||||2-Sided||||||||CI could not be computed due to 100% response rate||
1590614|NCT03197376|2924189|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 23F GMC Ratio|1.81|||||2-Sided|97.5|1.63|2.01|||||||
1590615|NCT03197376|2924189|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 19F GMC Ratio|0.73|||||2-Sided|97.5|0.67|0.8|||||||
1590616|NCT03197376|2924189|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 19A GMC Ratio|1.45|||||2-Sided|97.5|1.3|1.63||||||Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL|
1590617|NCT03197376|2924189|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 14 GMC Ratio|1.23|||||2-Sided|97.5|1.1|1.37|||||||
1590618|NCT03197376|2924189|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 9V GMC Ratio|0.92|||||2-Sided|97.5|0.85|1.0|||||||
1590619|NCT03197376|2924189|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 7F GMC Ratio|1.3|||||2-Sided|97.5|1.19|1.41|||||||
1590620|NCT03197376|2924189|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 6B GMC Ratio|1.07|||||2-Sided|97.5|0.93|1.24|||||||
1590621|NCT03197376|2924189|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 6A GMC Ratio|0.89|||||2-Sided|97.5|0.78|1.01||||||Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL|
1599056|NCT02858401|2938157|Other|||||||1|||||||Fisher Exact||||
1590623|NCT03197376|2924189|Non-Inferiority|Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL|Pn IgG type 1 GMC Ratio|2.15|||||2-Sided|97.5|2.0|2.32|||||||
1590624|NCT03197376|2924190|Non-Inferiority|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 23F|17.2|||||2-Sided|97.5|13.6|21.1|||||||
1590625|NCT03197376|2924190|Non-Inferiority|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 19F|-0.8|||||2-Sided|97.5|-1.9|0.5|||||||
1590626|NCT03197376|2924190|Non-Inferiority|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 19A|18.7|||||2-Sided|97.5|15.1|22.5||||||Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL|
1590627|NCT03197376|2924190|Non-Inferiority|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 14|-0.3|||||2-Sided|97.5|-1.4|1.0|||||||
1590628|NCT03197376|2924190|Non-Inferiority|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 9V|0.1|||||2-Sided|97.5|-1.9|2.5|||||||
1590629|NCT03197376|2924190|Non-Inferiority|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 7F|1.0|||||2-Sided|97.5|-0.1|2.7|||||||
1590630|NCT03197376|2924190|Non-Inferiority|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 6B|2.0|||||2-Sided|97.5|-2.2|6.4|||||||
1590631|NCT03197376|2924190|Non-Inferiority|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 6A|5.2|||||2-Sided|97.5|1.1|9.5||||||Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL|
1590632|NCT03197376|2924190|Non-Inferiority|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 5|2.8|||||2-Sided|97.5|1.2|5.0|||||||
1590633|NCT03197376|2924190|Non-Inferiority|Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10%, for 7 or more of the 10 serotypes in PNEUMOSIL|Absolute Difference for Type 1|0.7|||||2-Sided|97.5|0.0|1.9|||||||
1590634|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 23F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.0|||||2-Sided|95.0|0.89|1.13||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590635|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|1.29|||||2-Sided|95.0|1.16|1.44||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590636|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.95|||||2-Sided|95.0|0.85|1.06||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590637|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|1.02|||||2-Sided|95.0|0.89|1.17||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590638|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|0.82|||||2-Sided|95.0|0.74|0.9||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590639|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|0.69|||||2-Sided|95.0|0.62|0.76||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590676|NCT03194698|2924244|Superiority|||||||0.79|||||||Wilcoxon (Mann-Whitney)||||
1599057|NCT02858401|2938157|Other|||||||1|||||||Fisher Exact||||
1590640|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|0.62|||||2-Sided|95.0|0.52|0.74||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590641|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|0.95|||||2-Sided|95.0|0.82|1.09||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590642|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.98|||||2-Sided|95.0|0.9|1.07||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590643|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 1, Lot 2 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.93|||||2-Sided|95.0|0.85|1.01||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590644|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 24F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.03|||||2-Sided|95.0|0.92|1.15||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590645|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|1.08|||||2-Sided|95.0|0.97|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590646|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.88|||||2-Sided|95.0|0.79|0.98||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590647|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|0.95|||||2-Sided|95.0|0.83|1.09||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590648|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|0.88|||||2-Sided|95.0|0.8|0.97||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590649|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|0.75|||||2-Sided|95.0|0.68|0.83||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590650|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|0.87|||||2-Sided|95.0|0.74|1.04||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590651|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|1.04|||||2-Sided|95.0|0.91|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2|
1590652|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.73|||||2-Sided|95.0|0.67|0.8||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2|
1590677|NCT03194698|2924245|Superiority|||||||0.0312|||||||Wilcoxon (Mann-Whitney)||||
1591013|NCT03161938|2925187|Superiority|||||||0.447|||||||Chi-squared, Corrected|||day 0, restlessness|
1590653|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 1, Lot 1 and Lot 3 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.89|||||2-Sided|95.0|0.82|0.97||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590654|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 23F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 23F GMC Ratio|1.02|||||2-Sided|95.0|0.91|1.15||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590655|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19F GMC Ratio|0.84|||||2-Sided|95.0|0.76|0.92||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590656|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 19A, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 19A GMC Ratio|0.93|||||2-Sided|95.0|0.83|1.04||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590657|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 14, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 14 GMC Ratio|0.93|||||2-Sided|95.0|0.81|1.07||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590658|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 9V, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 9V GMC Ratio|1.08|||||2-Sided|95.0|0.98|1.18||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590659|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 7F, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 7F GMC Ratio|1.09|||||2-Sided|95.0|0.99|1.2||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590660|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6B, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6B GMC Ratio|1.41|||||2-Sided|95.0|1.18|1.69||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590661|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 6A, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 6A GMC Ratio|1.1|||||2-Sided|95.0|0.96|1.26||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590662|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for serotype 5, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 5 GMC Ratio|0.75|||||2-Sided|95.0|0.69|0.81||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590663|NCT03197376|2924191|Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the GMC of IgG antibody at one month following third vaccination was within this equivalence interval for each serotype 1, Lot 1 and Lot 2 would be equivalent with respect to the immune response to the vaccine lot|Pn IgG type 1 GMC Ratio|0.96|||||2-Sided|95.0|0.88|1.05||||||The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)|
1590664|NCT03195517|2924211|Other|||||||0.05|||||||t-test, 1 sided||||
1590665|NCT03195517|2924212|Other|||||||0.05|||||||t-test, 1 sided||||
1590666|NCT03195517|2924213|Other|||||||0.05|||||||t-test, 1 sided||||
1590667|NCT03195517|2924214|Other|||||||0.05|||||||t-test, 1 sided||||
1590668|NCT03195517|2924215|Other|||||||0.05|||||||t-test, 1 sided||||
1590669|NCT03195517|2924216|Other|||||||0.05|||||||t-test, 1 sided||||
1590670|NCT03195517|2924217|Other|||||||0.05|||||||t-test, 1 sided||||
1590671|NCT03195517|2924218|Other|||||||0.05|||||||t-test, 1 sided||||
1590672|NCT03195517|2924219|Other|||||||0.05|||||||t-test, 1 sided||||
1590673|NCT03195517|2924220|Other|||||||0.05|||||||t-test, 1 sided||||
1590674|NCT03194776|2924241|Superiority||Mean Difference (Final Values)|-17.74|||=|0|2-Sided|80.0|-38.03|2.55||P-value of <= 0.2 was considered significant.|two-sided test|||Statistical analysis was done by mixed effect model repeat measurement (MMRM) model analysis.|
1590675|NCT03194698|2924243|Superiority|||||||0.74|||||||Wilcoxon (Mann-Whitney)||||
1590678|NCT03194373|2924267|Superiority|Power to detect a 20% improvement in disease control rate (DCR). Based on historical data, the DCR in R/M HNSCC with single agent platinum therapy is 40%. We hypothesize that addition of Palbociclib will increase DCR at 12 weeks to 60%. Two-stage design. Type I error rate of 0.059 and power of 0.80 when the true response rate is 0.60 with alpha=0.05. The two-stage sample size calculations assume a null probability of 0.40.|Proportion|33.0|||||2-Sided|95.0|13.0|59.0|||||||
1590679|NCT03193047|2924293|Superiority||Median treatment difference|-28.512|Standard Error of the Mean|12.124||0.029|2-Sided|95.0|-51.455|-3.93|||Wilcoxon rank sum test||The median treatment difference (location shift) and the 95% confidence limits are from Hodges-Lehmann estimates.|hs-CRP at Month 2|
1590680|NCT03193047|2924293|Superiority||Median treatment difference|-32.479|Standard Error of the Mean|17.395||0.046|2-Sided|95.0|-70.524|-2.339|||Wilcoxon rank sum test||The median treatment difference (location shift) and the 95% confidence limits are from Hodges-Lehmann estimates.|hs-CRP at Month 1|
1590681|NCT03193047|2924294|Superiority||Least squares mean difference|-17.52|Standard Error of the Mean|3.809|<|0.001|2-Sided|95.0|-25.201|-9.839|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|TC at Month 2|
1590682|NCT03193047|2924294|Superiority||Least squares mean difference|-21.941|Standard Error of the Mean|3.572|<|0.001|2-Sided|95.0|-29.153|-14.729|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|TC at Month 1|
1590683|NCT03193047|2924294|Superiority||Least squares mean difference|-24.246|Standard Error of the Mean|4.838|<|0.001|2-Sided|95.0|-33.987|-14.505|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|non-HDL-C at Month 2|
1590684|NCT03193047|2924294|Superiority||Least squares mean difference|-31.64|Standard Error of the Mean|4.689|<|0.001|2-Sided|95.0|-41.116|-22.163|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|non-HDL-C at Month 1|
1590685|NCT03193047|2924294|Superiority||Least squares mean difference|-24.469|Standard Error of the Mean|4.33|<|0.001|2-Sided|95.0|-33.225|-15.713|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Apo B at Month 2|
1590686|NCT03193047|2924294|Superiority||Least squares mean difference|-27.031|Standard Error of the Mean|5.15|<|0.001|2-Sided|95.0|-37.509|-16.553|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Apo B at Month 1|
1590687|NCT03193047|2924295|Superiority||Least squares mean difference|-29.9|Standard Error of the Mean|5.606|<|0.001|2-Sided|95.0|-41.176|-18.626|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Month 2|
1590688|NCT03193047|2924295|Superiority||Least squares mean difference|-38.25|Standard Error of the Mean|5.602|<|0.001|2-Sided|95.0|-49.558|-26.944|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)|Month 1|
1590689|NCT03193047|2924296|Superiority||Lease squares mean difference|-35.884|Standard Error of the Mean|5.159|<|0.001|2-Sided|95.0|-46.303|-25.466|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)||
1590690|NCT03193047|2924297|Superiority||Least squares mean difference|-30.261|Standard Error of the Mean|5.502|<|0.001|2-Sided|95.0|-41.324|-19.199|||ANCOVA||(Bempedoic acid plus evolocumab) minus (placebo plus evolocumab)||
1590691|NCT03192826|2924308|Equivalence|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|2-Sided||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance||
1590692|NCT03192826|2924309|Equivalence|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|2-Sided||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance||
1590693|NCT03192826|2924310|Equivalence|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|2-Sided||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance||
1590694|NCT03192826|2924311|Equivalence|The SPSS statistical package version 23.0 (Statistical Package for the Social Sciences, version 23.0, SSPS Inc. Chicago, IL, USA) was used for statistical analysis.|Mean Difference (Final Values)|0.05|||<|0.05|2-Sided||||||ANOVA|Repeated measures ANOVA was used to compare parametric values with Bonferroni post hoc test for within group comparisons.|the reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance||
1590695|NCT03192475|2924312|Superiority|||||||0.82|||||||Mixed Models Analysis||||
1590696|NCT03192475|2924313|Superiority|||||||0.34|||||||Mixed Models Analysis||||
1590697|NCT03192475|2924314|Superiority|||||||0.18|||||||Mixed Models Analysis||||
1590698|NCT03192475|2924315|Superiority|||||||0.0009|||||||Mantel Haenszel||||
1590699|NCT03192475|2924316|Superiority|||||||0.96|||||||Mixed Models Analysis||||
1590700|NCT03192475|2924317|Superiority|||||||0.96|||||||Mixed Models Analysis||||
1590701|NCT03192475|2924318|Superiority|||||||0.15|||||||Mixed Models Analysis||||
1590702|NCT03192475|2924319|Superiority|||||||0.6|||||||Mixed Models Analysis||||
1590703|NCT03192475|2924320|Superiority|||||||0.21|||||||Mixed Models Analysis||||
1590704|NCT03192475|2924321|Superiority|||||||0.53|||||||Mixed Models Analysis||||
1590705|NCT03192475|2924322|Superiority|||||||0.09|||||||Mixed Models Analysis||||
1590706|NCT03192475|2924323|Superiority|||||||0.11|||||||Mixed Models Analysis||||
1590707|NCT03192475|2924324|Superiority|||||||0.25|||||||Mixed Models Analysis||||
1590708|NCT03192475|2924325|Superiority|||||||0.15|||||||Mixed Models Analysis||||
1590709|NCT03192475|2924326|Superiority|||||||0.01|||||||Mixed Models Analysis||||
1590710|NCT03191552|2924334|Superiority|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1590711|NCT03191552|2924335|Superiority|||||||0.244|||||||Wilcoxon (Mann-Whitney)||||
1590712|NCT03191552|2924336|Superiority|||||||0.314|||||||Wilcoxon (Mann-Whitney)||||
1590715|NCT03191552|2924339|Superiority||||||,|0||||||Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis||||
1590716|NCT03191552|2924340|Superiority|||||||0.956|||||||Kruskal-Wallis||||
1590717|NCT03191552|2924341|Superiority|||||||0.889|||||||Kruskal-Wallis||||
1590718|NCT03191552|2924342|Superiority|||||||0.77|||||||Kruskal-Wallis||||
1590719|NCT03191552|2924343|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1590720|NCT03191552|2924344|Superiority|||||||0.334|||||||Kruskal-Wallis||||
1590721|NCT03191552|2924345|Superiority|||||||0.57|||||||Kruskal-Wallis||||
1590722|NCT03191552|2924346|Superiority|||||||0.837|||||||Kruskal-Wallis||||
1590723|NCT03191552|2924347|Superiority|Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.||||||0.004||||||Mann-WhitneyU test was performed to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis||||
1590724|NCT03191552|2924348|Superiority|||||||0.008||||||Mann-WhitneyU test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis||||
1590725|NCT03191552|2924349|Superiority|||||||0.027||||||Mann-Whitney U test was used to test the significance of pairwise differences using Bonferroni correction to adjust for multiple comparisons.p value of less than 0.05/3 was determined as the level of statistical significance.|Kruskal-Wallis||||
1590726|NCT03191552|2924350|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1590727|NCT03191396|2924390|Superiority||Treatment difference|-3.83|||<|0.0001|2-Sided|95.0|-4.57|-3.09|||ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg||
1590728|NCT03191396|2924391|Superiority||Treatment difference|-0.69|||<|0.0001|2-Sided|95.0|-0.82|-0.56|||ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg||
1590729|NCT03191396|2924391|Non-Inferiority|HbA1c non-inferiority was tested using a non-inferiority margin of 0.3.|Treatment difference|-0.69|||<|0.0001|2-Sided|95.0|-0.82|-0.56||The non-inferiority p-value is calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3.|ANCOVA||Semaglutide 1.0 mg - Liraglutide 1.2 mg|The responses are analysed using an ANCOVA with treatment and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|
1590730|NCT03190993|2924392|Other|Linear mixed effect models were used to test if changes (Day 28 – Baseline) were equal between treatment groups (primary outcome).|Mean Difference (Net)|0.56|Standard Error of the Mean|0.43|=|0|2-Sided||||||Regression, Linear||||
1590731|NCT03190369|2924399|Superiority||LS Mean difference|0.125|Standard Error of the Mean|0.137||0.361|2-Sided|95.0|-0.144|0.395||Threshold for significance at 0.05 level.|ANCOVA|Least-square (LS) means, standard errors (SE) were analyzed from repeated measures ANCOVA.||Least-square (LS) means, standard errors (SE) were analyzed from repeated measures analysis of covariance (ANCOVA). The model included treatment groups (Hylan G-F 20 and placebo), site, visit and visit by treatment interaction, as well as the baseline WOMAC A1 score as a covariate).|
1590732|NCT03188523|2924426|Other||Posterior Probability (percentage)|99.0|||||||||||||Posterior Probability (percentage) of true geometric mean (GM) C168hr TFV-DP level in PBMCs ≥0.1 μM|PBMC TFV-DP C168hr values pooled, natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. The posterior probability that the true GM of PBMC TFV-DP C168hr level was ≥0.1 μM was calculated for the dose level using flat priors under a normal likelihood assumption. An 80% posterior probability for a dose level that also exhibits acceptable safety and tolerability would satisfy the secondary PK hypothesis.|
1590733|NCT03188523|2924426|Other||Posterior Probability (percentage)|99.0|||||||||||||Posterior Probability (percentage) of true geometric mean (GM) C168hr TFV-DP level in PBMCs ≥0.1 μM|PBMC TFV-DP C168hr values pooled, natural log transformed and analyzed based on a linear model containing a fixed effect for dose level. The posterior probability that the true GM of PBMC TFV-DP C168hr level was ≥0.1 μM was calculated for the dose level using flat priors under a normal likelihood assumption. An 80% posterior probability for a dose level that also exhibits acceptable safety and tolerability would satisfy the secondary PK hypothesis.|
1590734|NCT03188523|2924442|Superiority||Posterior Mean Difference|-0.92|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8504 and placebo at least 0.5 log10 copies/mL was >95%|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|
1590735|NCT03188523|2924442|Superiority||Posterior Mean Difference|-1.03|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between MK-8504 and placebo at least 0.5 log10 copies/mL was >98%|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean (95% confidence interval) for change from baseline at 168 hours post dose of pooled historical placebo was -0.03 log10 copies/mL (-0.14, 0.09).|
1590736|NCT03187197|2924459|Other|||||||0.1257|||||||Two sample T test|||Between group comparison of Visit 2 treatment satisfaction after PSM.|
1590737|NCT03187197|2924459|Other|||||||0.1301|||||||Two sample T test|||Between group comparison of Visit 2 treatment convenience after PSM.|
1590738|NCT03187197|2924459|Other|||||||0.6488|||||||t-test, 2 sided|||Between group comparison of Visit 3 treatment satisfaction before PSM.|
1590739|NCT03187197|2924459|Other|||||||0.0832|||||||t-test, 2 sided|||Between group comparison of Visit 2 treatment satisfaction before PSM.|
1590744|NCT03187197|2924460|Other|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline convenience with that of Visit 3.|
1590745|NCT03187197|2924460|Other|||||||0.0001|||||||Paired t-test|||Within group comparison of Baseline convenience with that of Visit 2.|
1590746|NCT03184519|2924504|Superiority||AUC|0.79||||0.025|1-Sided||||||t-test, 1 sided||||
1590747|NCT03184428|2924510|Other||||||<|0.05|||||||Spearman's rank-order correlation|Bonferroni adjustment in addition|||
1590748|NCT03184077|2924512|Superiority|||||||0.01||||||This is a calculated p value|Chi-squared||||
1590749|NCT03184077|2924513|Superiority|||||||0.62|||||||Chi-squared||||
1590750|NCT03184077|2924514|Superiority|||||||0.16|||||||Chi-squared||||
1590751|NCT03182920|2924539|Superiority||Ratio of geometric least squares means|1.26|||||2-Sided|90.0|1.03|1.55|||||||
1590752|NCT03182920|2924540|Superiority||Ratio of geometric least squares means|1.21|||||2-Sided|90.0|0.962|1.52|||||||
1590753|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|2.04||||0.64|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 6 months between two arms.|
1590754|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|1.5||||0.96|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 6 months between two arms.|
1590755|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|1.05||||0.96|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 6 months between two arms.|
1590756|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.77||||0.96|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 6 months between two arms.|
1590757|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.23||||0.96|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model|||The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.|"The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."
1590758|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|0.07||||0.96|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 6 months between two arms.|
1590759|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 6 months between two arms.|Difference in Change|-0.43||||0.96|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.|The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 6 months between two arms.|
1590760|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.84||||0.83|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Sleep Disturbance PROMIS T-score from baseline to 3 months between two arms.|
1590761|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Physical Function PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.55||||0.83|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm."|The null hypothesis is that there is no difference in change in Physical Function PROMIS T-score from baseline to 3 months between two arms.|
1590762|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|0.04||||0.98|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms.~Positive estimation parameter value indicates intervention arm better than control arm"|The null hypothesis is that there is no difference in change in Satisfaction with Social Role PROMIS T-score from baseline to 3 months between two arms|
1590763|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Pain Interference PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.78||||0.83|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Pain Interference PROMIS T-score from baseline to 3 months between two arms|
1590764|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Depression PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.79||||0.83|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Depression PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Depression PROMIS T-score from baseline to 3 months between two arms|
1590765|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Anxiety PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-0.94||||0.83|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Anxiety PROMIS T-score from baseline to 3 months between two arms|
1590766|NCT03182738|2924545|Superiority|Linear mixed models to test difference in mean score of Fatigue PROMIS T-score from baseline to 3 months between two arms.|Difference in Change|-2.09||||0.83|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||The parameter was estimated using a difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms|The null hypothesis is that there is no difference in change in Fatigue PROMIS T-score from baseline to 3 months between two arms|
1590767|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean depression score from period 1 to period 3 between the two arms."|Difference in Change|0.38||||0.05|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in depression score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 3 between the two arms"|
1590768|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean difficulty staying asleep score from period 1 to period 3 between the two arms."|Difference in Change|0.27||||0.09|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty staying asleep score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 3 between the two arms"|
1590769|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean dizziness score from period 1 to period 3 between the two arms."|Difference in Change|0.27||||0.08|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dizziness score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 3 between the two arms"|
1590770|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean unplanned changes in weight score from period 1 to period 3 between the two arms."|Difference in Change|0.26||||0.08|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in unplanned changes in weight score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 3 between the two arms"|
1590771|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean speech difficulties score from period 1 to period 3 between the two arms."|Difference in Change|0.25||||0.01|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in speech difficulties score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 3 between the two arms"|
1590772|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean decreased sex drive score from period 1 to period 3 between the two arms."|Difference in Change|0.24||||0.1|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in decreased sex drive score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 3 between the two arms"|
1590773|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean difficulty concentrating score from period 1 to period 3 between the two arms."|Difference in Change|0.2||||0.12|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty concentrating score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 3 between the two arms"|
1590774|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean difficulty falling asleep score from period 1 to period 3 between the two arms."|Difference in Change|0.19||||0.29|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty falling asleep score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 3 between the two arms"|
1590775|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean clumsy score from period 1 to period 3 between the two arms."|Difference in Change|0.18||||0.18|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in clumsy score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 3 between the two arms"|
1590776|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean pain during sex score from period 1 to period 3 between the two arms."|Difference in Change|0.14||||0.13|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in pain during sex score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 3 between the two arms"|
1590777|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean heartburn score from period 1 to period 3 between the two arms."|Difference in Change|0.11||||0.54|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in heartburn score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 3 between the two arms"|
1590778|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean cough score from period 1 to period 3 between the two arms."|Difference in Change|0.07||||0.84|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in cough score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 3 between the two arms"|
1590779|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean fever score from period 1 to period 3 between the two arms."|Difference in Change|0.06||||0.84|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fever score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 3 between the two arms"|
1590780|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean constipation score from period 1 to period 3 between the two arms."|Difference in Change|0.03||||0.93|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in constipation score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 3 between the two arms"|
1590781|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean anxiety score from period 1 to period 3 between the two arms."|Difference in Change|0.01||||0.95|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in anxiety score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 3 between the two arms"|
1590782|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean fatigue score from period 1 to period 3 between the two arms."|Difference in Change|0.01||||0.95|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fatigue score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 3 between the two arms"|
1590783|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean diarrhea score from period 1 to period 3 between the two arms."|Difference in Change|0.004||||0.97|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in diarrhea score from period 1 to period 3 between the two arms."|"The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 3 between the two arms"|
1590784|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean muscle aches score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.94|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in muscle aches score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 3 between the two arms"|
1590785|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean difficulty remembering score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.93|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty remembering score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 3 between the two arms"|
1590849|NCT03180801|2924590|Other|||||||0.024|||||||Fisher Exact|||One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.|
1590786|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean shortness of breath score from period 1 to period 3 between the two arms."|Difference in Change|-0.03||||0.93|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in shortness of breath score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 3 between the two arms"|
1590787|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean appetite change score from period 1 to period 3 between the two arms."|Difference in Change|-0.05||||0.88|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in appetite change score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 3 between the two arms"|
1590788|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean urination score from period 1 to period 3 between the two arms."|Difference in Change|-0.07||||0.71|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in urination score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 3 between the two arms"|
1590789|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean neuropathy score from period 1 to period 3 between the two arms."|Difference in Change|-0.08||||0.84|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in neuropathy score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 3 between the two arms"|
1590790|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean vomit score from period 1 to period 3 between the two arms."|Difference in Change|-0.11||||0.41|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in vomit score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 3 between the two arms"|
1590791|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean maintaining an erection score from period 1 to period 3 between the two arms."|Difference in Change|-0.13||||0.71|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in maintaining an erection score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean maintaining an erection score from period 1 to period 3 between the two arms"|
1590792|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean dry eyes score from period 1 to period 3 between the two arms."|Difference in Change|-0.24||||0.08|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry eyes score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 3 between the two arms"|
1590793|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean ringing in ear score from period 1 to period 3 between the two arms."|Difference in Change|-0.24||||0.08|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in ringing in ear score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 3 between the two arms"|
1590794|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean dry mouth score from period 1 to period 3 between the two arms."|Difference in Change|-0.27||||0.08|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry mouth score from period 1 to period 3 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 3 between the two arms"|
1590795|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean difficulty staying asleep score from period 1 to period 2 between the two arms."|Difference in Change|0.36||||0.01|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty staying asleep score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty staying asleep score from period 1 to period 2 between the two arms"|
1590796|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean depression score from period 1 to period 2 between the two arms."|Difference in Change|0.34||||0.02|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in depression score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean depression score from period 1 to period 2 between the two arms"|
1591014|NCT03161938|2925187|Superiority|||||||0.075|||||||Chi-squared, Corrected|||day 0, sadness|
1590797|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean unplanned changes in weight score from period 1 to period 2 between the two arms."|Difference in Change|0.22||||0.08|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in unplanned changes in weight score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean unplanned changes in weight score from period 1 to period 2 between the two arms"|
1590798|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean difficulty falling asleep score from period 1 to period 2 between the two arms."|Difference in Change|0.2||||0.15|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty falling asleep score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty falling asleep score from period 1 to period 2 between the two arms"|
1590799|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean shortness of breath score from period 1 to period 2 between the two arms."|Difference in Change|0.2||||0.11|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in shortness of breath score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean shortness of breath score from period 1 to period 2 between the two arms"|
1590800|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean difficulty concentrating score from period 1 to period 2 between the two arms."|Difference in Change|0.17||||0.11|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty concentrating score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean difficulty concentrating score from period 1 to period 2 between the two arms"|
1590801|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean anxiety score from period 1 to period 2 between the two arms."|Difference in Change|0.13||||0.35|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in anxiety score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean anxiety score from period 1 to period 2 between the two arms"|
1590802|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean decreased sex drive score from period 1 to period 2 between the two arms."|Difference in Change|0.11||||0.4|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in decreased sex drive score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean decreased sex drive score from period 1 to period 2 between the two arms"|
1590803|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean speech difficulties score from period 1 to period 2 between the two arms."|Difference in Change|0.1||||0.22|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in speech difficulties score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean speech difficulties score from period 1 to period 2 between the two arms"|
1590804|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean muscle aches score from period 1 to period 2 between the two arms."|Difference in Change|0.09||||0.56|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in muscle aches score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean muscle aches score from period 1 to period 2 between the two arms"|
1590805|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean dizziness score from period 1 to period 2 between the two arms."|Difference in Change|0.08||||0.54|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dizziness score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean dizziness score from period 1 to period 2 between the two arms"|
1590806|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean pain during sex score from period 1 to period 2 between the two arms."|Difference in Change|0.06||||0.48|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in pain during sex score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean pain during sex score from period 1 to period 2 between the two arms"|
1590807|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean fever score from period 1 to period 2 between the two arms."|Difference in Change|0.04||||0.72|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fever score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean fever score from period 1 to period 2 between the two arms"|
1590808|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean clumsy score from period 1 to period 2 between the two arms."|Difference in Change|0.03||||0.83|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in clumsy score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean clumsy score from period 1 to period 2 between the two arms"|
1590850|NCT03180801|2924590|Other|||||||1|||||||Fisher Exact|||One-sided Fisher's exact test is used to test if TEAE rate of vaccine group recorded pre-inoculation is higher than placebo.|
1590809|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean urination score from period 1 to period 2 between the two arms."|Difference in Change|0.02||||0.84|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in urination score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean urination score from period 1 to period 2 between the two arms"|
1590810|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean cough score from period 1 to period 2 between the two arms."|Difference in Change|0.01||||0.92|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in cough score from period 1 to period 2 between the two arms."|"The null hypothesis is that there is no difference in change in mean cough score from period 1 to period 2 between the two arms"|
1590811|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean fatigue score from period 1 to period 2 between the two arms."|Difference in Change|-0.07||||0.58|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in fatigue score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean fatigue score from period 1 to period 2 between the two arms"|
1590812|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean difficulty remembering score from period 1 to period 2 between the two arms."|Difference in Change|-0.1||||0.46|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in difficulty remembering score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean difficulty remembering score from period 1 to period 2 between the two arms"|
1590813|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean appetite change score from period 1 to period 2 between the two arms."|Difference in Change|-0.1||||0.46|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in appetite change score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean appetite change score from period 1 to period 2 between the two arms"|
1590814|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean constipation score from period 1 to period 2 between the two arms."|Difference in Change|-0.14||||0.33|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in constipation score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean constipation score from period 1 to period 2 between the two arms"|
1590815|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean diarrhea score from period 1 to period 2 between the two arms."|Difference in Change|-0.16||||0.21|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in diarrhea score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean diarrhea score from period 1 to period 2 between the two arms"|
1590816|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean heartburn score from period 1 to period 2 between the two arms."|Difference in Change|-0.19||||0.11|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in heartburn score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean heartburn score from period 1 to period 2 between the two arms"|
1590817|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean dry eyes score from period 1 to period 2 between the two arms."|Difference in Change|-0.24||||0.02|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry eyes score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry eyes score from period 1 to period 2 between the two arms"|
1590818|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean vomit score from period 1 to period 2 between the two arms."|Difference in Change|-0.28||||0.01|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in vomit score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean vomit score from period 1 to period 2 between the two arms"|
1590819|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean ringing in ear score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.01|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in ringing in ear score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean ringing in ear score from period 1 to period 2 between the two arms"|
1590939|NCT03171415|2924921|Superiority||||||>|0.05|||||||t-test, 2 sided||||
1591015|NCT03161938|2925188|Superiority|||||||0.604|||||||Chi-squared, Corrected|||day 4|
1590820|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean dry mouth score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.02|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in dry mouth score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean dry mouth score from period 1 to period 2 between the two arms"|
1590821|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean problems maintaining an erection score from period 1 to period 2 between the two arms."|Difference in Change|-0.29||||0.11|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in problems maintaining an erection score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean problems maintaining an erection score from period 1 to period 2 between the two arms"|
1590822|NCT03182738|2924546|Superiority|"Linear mixed models to test difference in mean neuropathy score from period 1 to period 2 between the two arms."|Difference in Change|-0.32||||0.02|2-Sided|||||Calculated p-value given the null-hypothesis. P value was adjusted for multiple-test with a false discovery rate (FDR).|Linear mixed model||"The parameter was estimated using a difference in change in neuropathy score from period 1 to period 2 between the two arms.~Negative estimation parameter value indicates intervention arm better than control arm."|"The null hypothesis is that there is no difference in change in mean neuropathy score from period 1 to period 2 between the two arms"|
1590823|NCT03182582|2924552|Superiority|||||||0.003|||||||Paired t test|||A sample size of 22 patients was required to achieve 80% power, using a two-tailed test with α = 0.05.|
1590824|NCT03181594|2924559|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1590825|NCT03181594|2924561|Superiority||||||<|0.001|||||||t-test, 2 sided|||The null hypothesis was that the mean change from baseline for the rTNSS would be 0 (no effect). Assumptions included an alpha level of 0.5 (2-tailed), 90% power, and a standard deviation of 2.5 for the mean change from baseline. A total of 68 participants was deemed adequate to test the hypothesis.|
1590826|NCT03180801|2924579|Other|||||||0.201|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.|
1590827|NCT03180801|2924579|Other|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower FLU-PRO scores than placebo.|
1590828|NCT03180801|2924580|Other|||||||0.178|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.|
1590829|NCT03180801|2924580|Other|||||||0.099|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer peak symptoms than placebo.|
1590830|NCT03180801|2924581|Other|||||||0.271|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.|
1590831|NCT03180801|2924581|Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has fewer average number of symptoms than placebo.|
1590832|NCT03180801|2924582|Other|||||||0.147|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.|
1590833|NCT03180801|2924582|Other|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter duration of symptoms than placebo.|
1590834|NCT03180801|2924583|Other|||||||0.601|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.|
1590835|NCT03180801|2924583|Other|||||||0.128|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has lower peak viral shedding than placebo.|
1590836|NCT03180801|2924586|Other|||||||0.481|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has a smaller shedding AUC than placebo.|
1590837|NCT03180801|2924586|Other|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has smaller shedding AUC than placebo.|
1590838|NCT03180801|2924587|Other|||||||0.3139|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.|
1590839|NCT03180801|2924587|Other|||||||0.0501|||||||Wilcoxon (Mann-Whitney)|||One-sided Wilcoxon test is used to test if vaccine group has shorter shedding duration than placebo.|
1590840|NCT03180801|2924588|Other|||||||0.12|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding|
1590841|NCT03180801|2924588|Other|||||||0.23|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects asymptomatic with detectable virus shedding|
1590842|NCT03180801|2924588|Other|||||||0.22|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding|
1590843|NCT03180801|2924588|Other|||||||0.09|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects with detectable virus shedding|
1590844|NCT03180801|2924588|Other|||||||0.23|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms.|
1590845|NCT03180801|2924588|Other|||||||0.024|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least two symptoms|
1590846|NCT03180801|2924588|Other|||||||0.074|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom|
1590847|NCT03180801|2924588|Other|||||||0.465|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower rate of subjects experiencing at least one symptom|
1590848|NCT03180801|2924590|Other|||||||0.186|||||||Fisher Exact|||One sided Fisher's exact test is used to test if TEAE rate of vaccine group post-inoculation is higher than the placebo group.|
1591016|NCT03161938|2925188|Superiority|||||||0.678|||||||Chi-squared, Corrected|||day 3|
1590851|NCT03180801|2924590|Other|One sided Fisher’s exact test is used to test if TEAE rates of vaccine group is higher than the placebo group.||||||0.647|||||||Fisher Exact|||One sided Fisher's exact test is used to test if the TEAE rates pre-inoculation recorded for the treatment group are higher than for placebo.|
1590852|NCT03180801|2924591|Other|||||||0.07|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.|
1590853|NCT03180801|2924591|Other|||||||0.03|||||||Fisher Exact|||One-sided Fisher exact test is used to test if vaccine group has lower MMID rate than placebo.|
1590854|NCT03180645|2924603|Other||Least square (LS) mean difference|-1.07||||0.0638|2-Sided|95.0|-2.21|0.06|||ANCOVA|Analysis model (ANCOVA) included participant as random effect, treatment arm and side of the face as fixed effects and baseline value as covariate.|Difference is the first named treatment adjusted (LS) mean change from baseline minus the second named treatment adjusted mean change from baseline.||
1590855|NCT03179345|2924691|Superiority||Mean Difference (Net)|-0.02|Standard Error of the Mean|0.53||0.9705|2-Sided|95.0|-1.089|1.049|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590856|NCT03179345|2924691|Superiority||Mean Difference (Net)|-0.488|Standard Error of the Mean|0.53||0.3666|2-Sided|95.0|-1.556|0.581|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590857|NCT03179345|2924692|Superiority||Mean Difference (Net)|-0.02|Standard Error of the Mean|0.53||0.9705|2-Sided|95.0|-1.089|1.049|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590858|NCT03179345|2924692|Superiority||Mean Difference (Net)|-0.116|Standard Error of the Mean|0.53||0.8293|2-Sided|95.0|-1.178|0.947|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590859|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.086|Standard Error of the Mean|0.13||0.5118|2-Sided|95.0|-0.346|0.174|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.||Motivation|SE of difference estimated by dividing width of 95% CI by 4.
1590860|NCT03179345|2924693|Superiority||Mean Difference (Net)|0.005|Standard Error of the Mean|0.12||0.9697|2-Sided|95.0|-0.241|0.251|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span|
1590861|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.055|Standard Error of the Mean|0.19||0.7761|2-Sided|95.0|-0.441|0.33|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness|
1590862|NCT03179345|2924693|Superiority||Mean Difference (Net)|0.082|Standard Error of the Mean|0.1||0.4143|2-Sided|95.0|-0.116|0.28|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness|
1590863|NCT03179345|2924693|Superiority||Mean Difference (Net)|0.152|Standard Error of the Mean|0.34||0.6554|2-Sided|95.0|-0.522|0.826|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness|
1590864|NCT03179345|2924693|Superiority||Mean Difference (Net)|0.039|Standard Error of the Mean|0.12||0.7498|2-Sided|95.0|-0.206|0.284|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness|
1590865|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.068|Standard Error of the Mean|0.06||0.2725|2-Sided|95.0|-0.191|0.055|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech|
1590866|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.101|Standard Error of the Mean|0.15||0.5068|2-Sided|95.0|-0.404|0.201|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration|
1590867|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.171|Standard Error of the Mean|0.06||0.0083|2-Sided|95.0|-0.296|-0.045|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor|
1590868|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.039|Standard Error of the Mean|0.14||0.7808|2-Sided|95.0|-0.316|0.238|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination|
1590869|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.024|Standard Error of the Mean|0.12||0.8479|2-Sided|95.0|-0.271|0.223|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in Activities|
1590870|NCT03179345|2924693|Superiority||Mean Difference (Net)|0.099|Standard Error of the Mean|0.15||0.519|2-Sided|95.0|-0.205|0.402|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance|
1590871|NCT03179345|2924693|Superiority||Mean Difference (Net)|0.118|Standard Error of the Mean|0.16||0.4612|2-Sided|95.0|-0.2|0.436|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory|
1590940|NCT03171415|2924922|Superiority||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups|
1590872|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.233|Standard Error of the Mean|0.19||0.2285|2-Sided|95.0|-0.614|0.149|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level|
1590873|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.078|Standard Error of the Mean|0.12||0.5101|2-Sided|95.0|-0.314|0.157|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision|
1590874|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.183|Standard Error of the Mean|0.13||0.1638|2-Sided|95.0|-0.443|0.0776|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Motivation|
1590875|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.127|Standard Error of the Mean|0.12||0.3083|2-Sided|95.0|-0.372|0.119|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span|
1590876|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.309|Standard Error of the Mean|0.19||0.1145|2-Sided|95.0|-0.695|0.076|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness|
1590877|NCT03179345|2924693|Superiority||Mean Difference (Net)|0.084|Standard Error of the Mean|0.1||0.4039|2-Sided|95.0|-0.115|0.282|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness|
1590878|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.483|Standard Error of the Mean|0.34||0.1574|2-Sided|95.0|-1.157|0.19|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness|
1590879|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.057|Standard Error of the Mean|0.12||0.6422|2-Sided|95.0|-0.302|0.187|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness|
1590880|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.031|Standard Error of the Mean|0.06||0.6215|2-Sided|95.0|-0.154|0.092|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech|
1590881|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.057|Standard Error of the Mean|0.15||0.7099|2-Sided|95.0|-0.359|0.246|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration|
1590882|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.072|Standard Error of the Mean|0.06||0.2591|2-Sided|95.0|-0.197|0.054|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor|
1590883|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.171|Standard Error of the Mean|0.14||0.2229|2-Sided|95.0|-0.447|0.106|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination|
1590884|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.05|Standard Error of the Mean|0.12||0.6891|2-Sided|95.0|-0.296|0.197|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in Activities|
1590885|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.198|Standard Error of the Mean|0.15||0.1968|2-Sided|95.0|-0.502|0.105|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance|
1590886|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.048|Standard Error of the Mean|0.16||0.7633|2-Sided|95.0|-0.366|0.269|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory|
1590887|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.216|Standard Error of the Mean|0.19||0.2618|2-Sided|95.0|-0.597|0.165|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level|
1590888|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.213|Standard Error of the Mean|0.12||0.0767|2-Sided|95.0|-0.448|0.023|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision|
1590889|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.047|Standard Error of the Mean|0.13||0.7201|2-Sided|95.0|-0.305|0.212|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Motivation|
1590890|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.113|Standard Error of the Mean|0.12||0.3613|2-Sided|95.0|-0.357|0.132|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Attention Span|
1590891|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.153|Standard Error of the Mean|0.19||0.4294|2-Sided|95.0|-0.537|0.231|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Alertness|
1590941|NCT03171415|2924922|Superiority||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups|
1590892|NCT03179345|2924693|Superiority||Mean Difference (Net)|0.018|Standard Error of the Mean|0.1||0.8543|2-Sided|95.0|-0.179|0.216|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Moodiness|
1590893|NCT03179345|2924693|Superiority||Mean Difference (Net)|0.057|Standard Error of the Mean|0.34||0.8658|2-Sided|95.0|-0.613|0.727|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Sleepiness|
1590894|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.109|Standard Error of the Mean|0.12||0.3774|2-Sided|95.0|-0.352|0.135|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Forgetfulness|
1590895|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.098|Standard Error of the Mean|0.06||0.1144|2-Sided|95.0|-0.22|0.024|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Speech|
1590896|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.084|Standard Error of the Mean|0.15||0.5811|2-Sided|95.0|-0.384|0.217|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Concentration|
1590897|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.14|Standard Error of the Mean|0.06||0.0304|2-Sided|95.0|-0.266|-0.014|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Tremor|
1590898|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.212|Standard Error of the Mean|0.14||0.1293|2-Sided|95.0|-0.487|0.063|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Coordination|
1590899|NCT03179345|2924693|Superiority||Mean Difference (Net)|0.017|Standard Error of the Mean|0.12||0.8925|2-Sided|95.0|-0.229|0.262|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Interest in activities|
1590900|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.121|Standard Error of the Mean|0.15||0.4255|2-Sided|95.0|-0.423|0.18|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Walking Balance|
1590901|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.046|Standard Error of the Mean|0.16||0.7724|2-Sided|95.0|-0.362|0.27|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Memory|
1590902|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.157|Standard Error of the Mean|0.19||0.412|2-Sided|95.0|-0.536|0.222|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Energy Level|
1590903|NCT03179345|2924693|Superiority||Mean Difference (Net)|-0.286|Standard Error of the Mean|0.12||0.0177|2-Sided|95.0|-0.521|-0.051|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.|Vision|
1590904|NCT03179345|2924694|Superiority||Mean Difference (Net)|0.51|Standard Error of the Mean|0.309||0.1041|2-Sided|95.0|-0.107|1.127|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590905|NCT03179345|2924694|Superiority||Mean Difference (Net)|-0.094|Standard Error of the Mean|0.309||0.7634|2-Sided|95.0|-0.711|0.523|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590906|NCT03179345|2924694|Superiority||Mean Difference (Net)|0.51|Standard Error of the Mean|0.307||0.1026|2-Sided|95.0|-0.104|1.124|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590907|NCT03179345|2924695|Superiority||Mean Difference (Net)|-0.01|Standard Error of the Mean|0.0175||0.5084|2-Sided|95.0|-0.05|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590908|NCT03179345|2924695|Superiority||Mean Difference (Net)|0.01|Standard Error of the Mean|0.0175||0.5183|2-Sided|95.0|-0.02|0.05|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590909|NCT03179345|2924695|Superiority||Mean Difference (Net)|-0.05|Standard Error of the Mean|0.0175||0.007|2-Sided|95.0|-0.08|-0.01|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590910|NCT03179345|2924696|Superiority||Mean Difference (Net)|0.37|Standard Error of the Mean|0.865||0.6741|2-Sided|95.0|-1.36|2.1|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590911|NCT03179345|2924696|Superiority||Mean Difference (Net)|0.33|Standard Error of the Mean|0.865||0.7057|2-Sided|95.0|-1.4|2.06|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590942|NCT03171415|2924922|Superiority||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups, at day 28 and Day 56|
1591017|NCT03161938|2925188|Superiority|||||||0.447|||||||Chi-squared, Corrected|||day 2|
1590912|NCT03179345|2924696|Superiority||Mean Difference (Net)|-0.46|Standard Error of the Mean|0.86||0.595|2-Sided|95.0|-2.18|1.26|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590913|NCT03179345|2924697|Superiority||Mean Difference (Net)|-0.01|Standard Error of the Mean|0.01||0.3262|2-Sided|95.0|-0.03|0.01|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590914|NCT03179345|2924697|Superiority||Mean Difference (Net)|0.0|Standard Error of the Mean|0.01||0.9048|2-Sided|95.0|-0.02|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590915|NCT03179345|2924697|Superiority||Mean Difference (Net)|0.0|Standard Error of the Mean|0.0125||0.7111|2-Sided|95.0|-0.03|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590916|NCT03179345|2924698|Superiority||Mean Difference (Net)|-3.73||||0.1587|2-Sided|95.0|-8.94|1.49|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590917|NCT03179345|2924698|Superiority||Mean Difference (Net)|0.24|Standard Error of the Mean|2.61||0.9277|2-Sided|95.0|-4.97|5.45|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590918|NCT03179345|2924698|Superiority||Mean Difference (Net)|-0.4|Standard Error of the Mean|2.6||0.8799|2-Sided|95.0|-5.59|4.8|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590919|NCT03179345|2924699|Superiority||Mean Difference (Net)|0.01|Standard Error of the Mean|0.0125||0.6208|2-Sided|95.0|-0.02|0.03|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590920|NCT03179345|2924699|Superiority||Mean Difference (Net)|0.02|Standard Error of the Mean|0.0125||0.1673|2-Sided|95.0|-0.01|0.04|||ANCOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590921|NCT03179345|2924699|Superiority||Mean Difference (Net)|0.0|Standard Error of the Mean|0.01||0.9946|2-Sided|95.0|-0.02|0.02|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590922|NCT03179345|2924700|Superiority||Mean Difference (Net)|0.12|Standard Error of the Mean|0.06||0.0611|2-Sided|95.0|-0.006|0.245|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590923|NCT03179345|2924700|Superiority||Mean Difference (Net)|-0.102|Standard Error of the Mean|0.06||0.1103|2-Sided|95.0|-0.227|0.024|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590924|NCT03179345|2924701|Superiority||Mean Difference (Net)|0.12|Standard Error of the Mean|0.06||0.0611|2-Sided|95.0|-0.006|0.245|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590925|NCT03179345|2924701|Superiority||Mean Difference (Net)|-0.141|Standard Error of the Mean|0.06||0.0275|2-Sided|95.0|-0.266|-0.016|||ANOVA|Mixed model including terms for sequence, study treatment, and period as fixed effects and subject nested within Sequence as a random effect.|SE of difference estimated by dividing width of 95% CI by 4.||
1590926|NCT03178344|2924709|Equivalence|ANOVA||||||0.71||||||P value threshold is 0.05.|ANOVA||||
1590927|NCT03178344|2924710|Equivalence|ANOVA||||||0.7||||||P value threshold is 0.05|ANOVA||||
1590928|NCT03175120|2924873|Superiority||Treatment contrast|-0.92|||<|0.0001|2-Sided|95.0|-1.09|-0.75|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance (ANCOVA) model with treatment and previous anti-diabetic treatment as fixed factors and corresponding baseline value as covariate.|
1590929|NCT03174158|2924884|Superiority|||||||0.21||||||a priori threshold p<0.05|Chi-squared||||
1590930|NCT03174158|2924884|Superiority|||||||0.18|||||||Chi-squared|a priori threshold p<0.05|||
1590931|NCT03174158|2924884|Superiority|||||||0.07||||||a priori p value threshold < 0.05|Chi-squared||||
1590932|NCT03173170|2924887|Other||Mean ratio|1.4892|||||2-Sided|90.0|1.3851|1.6012||||||A paired t-test on the natural log-transformed parameters was performed. The means and difference of means for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.|
1590933|NCT03173170|2924888|Other||Mean ratio|1.0622|||||2-Sided|90.0|0.9569|1.1792||||||A paired t-test on the natural log-transformed parameters was performed. The means and difference of means for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90 percent (%) confidence intervals (CIs).|
1590934|NCT03172481|2924907|Other|The primary efficacy analysis used a mixed-model repeated measures (MMRM) analysis on the full day laboratory classroom SKAMP-C scores from each time point as the dependent variable. The repeated measures model adjusted means (LS-means) for PRC-063 and placebo were compared statistically using a t-test with an overall 5% significance level to evaluate efficacy. The LS-means estimate an overall treatment effect across the entire 13-hour classroom evaluation.|||||<|0.0001|||||||ANOVA||||
1590935|NCT03171415|2924915|Other||||||>|0.05|||||||t-test, 2 sided||||
1590936|NCT03171415|2924921|Other||||||>|0.05|||||||t-test, 2 sided||||
1590937|NCT03171415|2924921|Other||||||>|0.05|||||||t-test, 2 sided||||
1590938|NCT03171415|2924921|Other||||||>|0.05|||||||t-test, 2 sided||||
1590943|NCT03171415|2924922|Superiority||||||>|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis T-test was applied for analyzing the difference in between the study groups|
1590944|NCT03170544|2924955|Other||Mean|2.74|Standard Error of the Mean|0.326|||2-Sided|95.0|2.03|3.44|||||Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).||The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).
1590945|NCT03170544|2924955|Other||Mean|1.33|Standard Error of the Mean|0.326|||2-Sided|95.0|0.63|2.04|||||Mean (SE) and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK1092 Doses, Glargine).||The primary hypothesis would be supported if the Bayesian posterior probability of the true mean of GIRmax of MK-1092 lying within 1.5 and 4.5 mg/kg/min exceeded the prespecified threshold of 70% (in Part 3).
1590946|NCT03170232|2924978|Other||Mean Difference (Final Values)|-67.2|Standard Error of the Mean|159.7||0.679|2-Sided|95.0|-400.6|266.2|||Repeated measures random coefficient||||
1590947|NCT03170154|2925002|Other||1-sided 95% Upper CL|99.98|||||1-Sided|95.0|||||||||
1590948|NCT03170154|2925003|Other||1-sided 95% Upper CL|99.99|||||1-Sided||||||||||
1590949|NCT03169153|2925011|Superiority||||||<|0.0001|||||||Mixed effects repeated measures||||
1590950|NCT03168919|2925018|Other|Comparison||||||||||||||||The baseline and the end of therapy MRI parameters are compared.|Due to very small accrual, the statistical analysis couln't be performed.
1590951|NCT03168542|2925041|Superiority|Superiority was concluded if the lower 95% of the confidence limit of the proportion of subjects who require no more than one modification was greater than 50%.|Proportion|0.952|||||2-Sided|95.0|0.756|1.0|||||||
1590952|NCT03166124|2925075|Superiority||Ratio of Geometric LSMeans|1.02|||||2-Sided|95.0|0.94|1.1||||||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.|
1590953|NCT03166124|2925075|Superiority||Ratio of Geometric LSMeans|1.04|||||2-Sided|95.0|0.96|1.12||||||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.|
1590954|NCT03166124|2925076|Superiority||Ratio of Geometric LSMeans|1.03|||||2-Sided|95.0|0.974|1.09||||||Geometric Least Squares Means (LSMeans) were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.|
1590955|NCT03166124|2925076|Superiority||Ratio of Geometric LSMeans|1.02|||||2-Sided|95.0|0.953|1.1||||||Geometric LSMeans were controlled for injection site, study period, and sequence as fixed effects, and subject within sequence as a random effect.|
1590956|NCT03165981|2925080|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1590957|NCT03165981|2925082|Superiority|||||||0.848|||||||Wilcoxon (Mann-Whitney)||||
1590958|NCT03165981|2925083|Superiority||Risk Ratio (RR)|0.73||||0.6101|2-Sided|95.0|0.21|2.48|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.||
1590959|NCT03165981|2925084|Superiority|||||||0.3408|||||||Mantel Haenszel|Mantel Haenzel is stratified by site.|||
1590960|NCT03165981|2925085|Superiority||Risk Ratio (RR)|0.87||||0.8325|2-Sided|95.0|0.24|3.13|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.||
1590961|NCT03165981|2925086|Superiority|||||||0.3408|||||||Mantel Haenszel|Mantel Haenzel is stratified by site.|||
1590962|NCT03165981|2925087|Superiority||Risk Ratio (RR)|0.97||||0.9412|2-Sided|95.0|0.39|2.4|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.||
1590963|NCT03165981|2925088|Superiority||Risk Ratio (RR)|0.87||||0.7588|2-Sided|95.0|0.36|2.1|||Mantel Haenszel|Mantel Haenzel is stratified by site.|RR is adjusted by site.||
1590964|NCT03165175|2925100|Superiority|||||||0.022||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA||||
1590965|NCT03165175|2925101|Superiority|||||||0.167||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA||||
1590966|NCT03165175|2925102|Superiority|||||||0.954||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA||||
1590967|NCT03165175|2925103|Superiority|||||||0.598||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA||||
1590968|NCT03165175|2925104|Superiority|||||||0.72||||||This p-value is the for the group by time (group: intervention/control, by time: baseline/1 month) interaction.|ANOVA||||
1590969|NCT03163134|2925124|Other|||||||0.577|||||||Chi-squared||||
1590970|NCT03163134|2925125|Other|||||||0.017|||||||Chi-squared||||
1590971|NCT03162614|2925153|Other|Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|29.0||||0.009|2-Sided|95.0|6.0|46.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 7 (Adu1Fx Group versus Control Group).|
1590972|NCT03162614|2925153|Other|Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|55.0|||<|0.001|2-Sided|95.0|27.0|72.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full dose at Month 0 and 1/5th dose at Month 1 and Month 7 (Adu2Fx Group versus Control Group).|
1590973|NCT03162614|2925153|Other|Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|64.0|||<|0.001|2-Sided|95.0|37.0|79.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01E administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (PedFx Group versus Control Group).|
1590974|NCT03162614|2925153|Other|Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|76.0|||<|0.001|2-Sided|95.0|49.0|89.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01E administered as double full doses at Month 0 and Month 1 and 1/5th double dose at Month 7 (2Ped Fx Group versus Control Group).|
1591001|NCT03161938|2925187|Superiority|||||||0.042|||||||Chi-squared, Corrected|||Day 4, restlessness|
1590975|NCT03162614|2925153|Other|Vaccine efficacy rate was calculated as 100*(1-RR) with RR=relative risk of developing the disease for vaccinated people compared to unvaccinated people.|Vaccine efficacy rate|55.0|||<|0.001|2-Sided|95.0|27.0|72.0|||Fisher Exact|||Efficacy analysis aimed at comparing RTS,S/AS01B administered as full doses at Month 0 and Month 1 and 1/5th dose at Month 7 (AduFx Group versus Control Group).|
1590976|NCT03162458|2925154|Superiority|||||||1|||||||Fisher Exact||||
1590977|NCT03162458|2925155|Superiority|||||||0.63|||||||ANOVA||||
1590978|NCT03162458|2925156|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1590979|NCT03162458|2925157|Superiority|||||||0.004|||||||ANOVA||||
1590980|NCT03162458|2925158|Superiority|||||||0.15|||||||Log Rank||||
1590981|NCT03162458|2925159|Superiority|||||||0.44|||||||ANOVA|||Mean body temperatures, measured in the evening on Days 2-5 (based on patient diary data)|
1590982|NCT03162458|2925159|Superiority|||||||0.19|||||||ANOVA|||Mean body temperatures, measured in the morning on Days 2-5 (based on patient diary data)|
1590983|NCT03162458|2925160|Superiority|||||||0.051|||||||Wilcoxon (Mann-Whitney)||||
1590984|NCT03162458|2925161|Superiority|||||||0.055|||||||Log Rank||||
1590985|NCT03162458|2925162|Superiority|||||||0.0004|||||||Wilcoxon (Mann-Whitney)||||
1590986|NCT03162458|2925163|Superiority|||||||0.007|||||||Wilcoxon (Mann-Whitney)||||
1590987|NCT03162328|2925173|Superiority|||||||0.291|||||||Wilcoxon Signed Ranks Test||||
1590988|NCT03162328|2925174|Superiority|||||||0.363|||||||Wilcoxon Signed Ranks Test||||
1590989|NCT03162055|2925175|Superiority||Least Square Mean Difference|-1.7|Standard Error of the Mean|12.8||0.5516|2-Sided|97.5|-30.3|27.0|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.||
1590990|NCT03162055|2925176|Non-Inferiority|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 2.0 unit.|Least Square Mean Difference|0.59|Standard Error of the Mean|0.27|<|0.0001|2-Sided|95.0|0.07|1.11|||Repeated measures analysis|Change from baseline = Treatment + baseline CAT score + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.||
1590991|NCT03162055|2925177|Superiority||Least Square Mean Difference|0.65|Standard Error of the Mean|0.2||0.9995|2-Sided|95.0|0.26|1.04|||Repeated measures analysis|Change from baseline =Treatment + baseline rescue a/s MDI use + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.||
1590992|NCT03162055|2925178|Non-Inferiority|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 0.1 unit.|Least Square Mean Difference|0.042|Standard Error of the Mean|0.024||0.0088|2-Sided|95.0|-0.005|0.09|||Repeated measures analysis|Change from baseline = Treatment + baseline NiSCI score + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.||
1590993|NCT03162055|2925179|Non-Inferiority|Non-inferiority p-value is calculated corresponding to the non-inferiority margin 0.1 unit.|Least Square Mean Difference|0.034|Standard Error of the Mean|0.023||0.0017|2-Sided|95.0|-0.011|0.078|||Repeated measures analysis|Change from baseline = Treatment + baseline EMSCI score + BR a/s MDI + stratification factor (prior treatment) + region + TI + treatment by TI.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.||
1590994|NCT03162055|2925180|Non-Inferiority|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -1.0 unit.|Least Square Mean Difference|-0.37|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.59|-0.14|||Repeated measures analysis|TDI focal score = Treatment + Baseline Dyspnea Index + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean TDI focal score over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.||
1590995|NCT03162055|2925181|Non-Inferiority|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-15.2|Standard Error of the Mean|19.4||0.0371|2-Sided|95.0|-53.4|22.9|||Repeated measures analysis|Change from baseline = Treatment + baseline IC + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.||
1590996|NCT03162055|2925182|Superiority||Odds Ratio (OR)|2.3|||<|0.0001|2-Sided|95.0|1.79|2.95|||Regression, Logistic|ln (1/(1-p))=Treatment+baseline FEV1+BR a/s MDI+stratification factor (prior treatment)+region.p=percentage of participants with increase of >=100 mL.|Estimate of the log odds of being a responder in the GFF treatment group compared to the UV treatment group using a logistic regression.||
1590997|NCT03162055|2925183|Non-Inferiority|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-3.4|Standard Error of the Mean|13.1||0.0002|2-Sided|97.5|-32.8|25.9|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean peak change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.||
1590998|NCT03162055|2925184|Non-Inferiority|Non-inferiority p-value is calculated corresponding to the non-inferiority margin -50 mL.|Least Square Mean Difference|-87.2|Standard Error of the Mean|13.3||0.9974|2-Sided|97.5|-117.0|-57.4|||Repeated measures analysis|Change from baseline = Treatment + baseline FEV1 + BR a/s MDI + stratification factor (prior treatment) + region + visit + treatment by visit.|Estimate of the mean change from baseline over 24 weeks in the GFF treatment group is compared to the UV treatment group using a repeated measures analysis.||
1590999|NCT03161938|2925186|Superiority|||||||0.613|||||||Chi-squared, Corrected||||
1591000|NCT03161938|2925187|Superiority|||||||0.097|||||||Chi-squared, Corrected|||Day 4, fatigue|
1591020|NCT03161938|2925189|Superiority|||||||0.666|||||||Chi-squared, Corrected|||day 4|
1591021|NCT03161938|2925189|Superiority|||||||0.32|||||||Chi-squared, Corrected|||Day 3|
1591022|NCT03161938|2925189|Superiority|||||||0.59|||||||Chi-squared, Corrected|||Day 2|
1591023|NCT03161938|2925189|Superiority|||||||0.376|||||||Chi-squared, Corrected|||Day 1|
1591024|NCT03161938|2925189|Superiority|||||||0.768||||||Not adjusted for multiple comparisons, statistical level of significance 0.01 (bonferroni correction)|Chi-squared, Corrected|||Day 0|
1591025|NCT03161938|2925190|Superiority|||||||0.133|||||||Regression, Linear||||
1591026|NCT03161938|2925191|Superiority||Odds Ratio (OR)|1.19||||0.768|2-Sided|95.0|0.374|3.793|||Chi-squared, Corrected||||
1591027|NCT03161938|2925192|Superiority|||||||0.722|||||||Wilcoxon (Mann-Whitney)|||Average pain|
1591028|NCT03161938|2925192|Superiority|||||||0.913|||||||Wilcoxon (Mann-Whitney)|||Maximal pain|
1591029|NCT03161938|2925193|Superiority|||||||0.468|||||||Wilcoxon (Mann-Whitney)||||
1591030|NCT03161938|2925194|Superiority|||||||0.519|||||||Wilcoxon (Mann-Whitney)||||
1591031|NCT03161938|2925195|Superiority||Odds Ratio (OR)|0.508||||0.248|2-Sided|95.0|0.159|1.62|||Chi-squared, Corrected|||Null hypothesis: Patients receiving 48 mg of preoperative dexamethasone have less postoperative pain. Power calculation: Acute pain is reduced from 70% to 35% for patients receiving 48 mg of dexamathesone, 80% power, 0.05 statistical significance level.|
1591032|NCT03161405|2925196|Other||Geometric mean ratio|1.2783|||||2-Sided|90.0|1.0965|1.4904||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.|
1591033|NCT03161405|2925197|Other||Geometric mean ratio|1.2914|||||2-Sided|90.0|1.1199|1.4891||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90% CI for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.|
1591034|NCT03161405|2925198|Other||Geometric mean ratio|1.9827|||||2-Sided|90.0|1.6446|2.3904||||||A paired t-test on the natural log-transformed parameters was performed. The mean difference and its 90 percent (%) confidence interval (CI) for the log-transformed parameters were exponentiated to obtain the point estimates of the itraconazole effect and 90% CIs.|
1591035|NCT03160703|2925204|Superiority||Mean Difference (Final Values)|0.07||||0.0001|2-Sided|95.0|0.03|0.1||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.||
1591036|NCT03160703|2925204|Superiority||Mean Difference (Final Values)|0.03||||0.0779|2-Sided|95.0|0.0|0.06||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.||
1591037|NCT03160703|2925204|Superiority||Mean Difference (Final Values)|-0.11|||<|0.0001|2-Sided|95.0|-0.15|-0.08||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.||
1591038|NCT03160703|2925204|Superiority||Mean Difference (Net)|-0.08|||<|0.0001|2-Sided|95.0|-0.12|-0.05||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.||
1591039|NCT03160703|2925204|Superiority||Mean Difference (Net)|-0.05|||<|0.0043|2-Sided|95.0|-0.08|-0.02||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.||
1591040|NCT03160703|2925204|Superiority||Mean Difference (Net)|-0.02|||<|0.2681|2-Sided|95.0|-0.05|0.01||Statistical significance set at 5% level|ANCOVA|From ANCOVA with treatment and smoking status as factors and baseline pre-prophylaxis overall MLSI score as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.||
1591041|NCT03160170|2925205|Superiority|||||||0.05|||||||t-test, 2 sided||||
1591042|NCT03160170|2925206|Superiority|||||||0.11|||||||t-test, 2 sided||||
1591043|NCT03160170|2925207|Superiority|||||||0.96|||||||t-test, 2 sided||||
1591044|NCT03159611|2925221|Superiority|||||||0.19|||||||Wilcoxon (Mann-Whitney)||||
1591045|NCT03159611|2925222|Superiority|||||||0.2|||||||Cochran-Mantel-Haenszel||||
1591046|NCT03159611|2925223|Superiority|||||||0.5|||||||Mixed Models Analysis||||
1591047|NCT03159611|2925224|Superiority|||||||0.005|||||||Cochran-Mantel-Haenszel||||
1591048|NCT03159611|2925225|Superiority|||||||0.002|||||||Fisher Exact||||
1591049|NCT03159468|2925226|Other|||||||0.462||||||This p-value is for the beverage condition by intervention condition interaction.|ANOVA||||
1591050|NCT03159468|2925226|Other|||||||0.16||||||This p-value is for the main effect of intervention condition.|ANOVA||||
1591051|NCT03159468|2925226|Other|||||||0.041||||||This p-value is for the main effect of beverage condition.|ANOVA||||
1591052|NCT03159299|2925250|Superiority||Mean Difference (Final Values)|0.11|||<|0.15|2-Sided||||||Mixed Models Analysis||||
1591053|NCT03158220|2925261|Other||Difference in Percentages|-1.0||||0.3|2-Sided|95.0|-3.1|0.9|||Miettinen & Nurminen||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.||
1591054|NCT03158220|2925262|Other||Difference in Percentages|-1.9|||||2-Sided|95.0|-7.3|3.4|||||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.||
1591055|NCT03158220|2925263|Other||Difference in Percentages|-2.5||||0.212|2-Sided|95.0|-6.4|1.4|||Miettinen & Nurminen||Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.||
1591398|NCT03127644|2926229|Superiority|||||||0.0006||||||Nominal p value|Log Rank||||
1591056|NCT03158220|2925266|Non-Inferiority|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.69|||<|0.001|2-Sided|95.0|0.63|0.76||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 58|
1591057|NCT03158220|2925266|Non-Inferiority|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.71|||<|0.001|2-Sided|95.0|0.64|0.78||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 52|
1591058|NCT03158220|2925266|Non-Inferiority|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.68|||<|0.001|2-Sided|95.0|0.6|0.76||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 45|
1591059|NCT03158220|2925266|Non-Inferiority|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.73|||<|0.001|2-Sided|95.0|0.67|0.8||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 33|
1591060|NCT03158220|2925266|Non-Inferiority|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.66|||<|0.001|2-Sided|95.0|0.6|0.74||ANOVA model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 31|
1591061|NCT03158220|2925266|Non-Inferiority|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.71|||<|0.001|2-Sided|95.0|0.64|0.8||Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 18|
1591062|NCT03158220|2925266|Non-Inferiority|Non-inferiority of GMT in 27-45 year-olds relative to 16-26 year-olds was demonstrated if the lower limit of the 95% confidence interval (CI) for the fold difference was greater than 0.5.|Fold Difference|0.7|||<|0.001|2-Sided|95.0|0.63|0.77||Analysis of variance (ANOVA) model with response of log individual titers and a fixed effect for age groups.|ANOVA||Fold difference calculated as GMT 27-45 year-olds/GMT 16-26 year-olds|Anti HPV 16|
1591063|NCT03158038|2925270|Superiority||Rate difference|0.4|||||2-Sided|95.0|-14.1|13.2||||||Statistical analysis up to Day 15|
1591064|NCT03158038|2925270|Superiority||Rate difference|1.3|||||2-Sided|95.0|-12.8|13.2||||||Statistical analysis up to Day 8|
1591065|NCT03158038|2925271|Superiority||Rate difference|0.0|||||2-Sided|95.0|-6.7|1.9|||||||
1591066|NCT03155269|2925305|Other||Mean Difference (Final Values)|0.229||||0.0469|2-Sided|97.5|-0.03|0.489||The setting of the two-sided significance level of 0.025 was used for the 2 co-primary endpoints to ensure that the overall significance level for the primary endpoint was less than or equal to 0.05.|ANCOVA|Analysis was performed using ANCOVA model with product group and strata as fixed effects, and the corresponding baseline value as covariate.|Difference is test product minus reference product such that a negative difference favors the test product.||
1591067|NCT03155269|2925306|Other||Mean Difference (Final Values)|-0.0423||||0.1324|2-Sided|97.5|-0.1057|0.0211||The setting of the two-sided significance level of 0.025 was used for the 2 co-primary endpoints to ensure that the overall significance level for the primary endpoint was less than or equal to 0.05.|ANCOVA|Analysis was performed using ANCOVA model with product group and strata as fixed effects, and the corresponding baseline value as covariate.|Difference is test product minus reference product such that a negative difference favors the test product.||
1591068|NCT03155178|2925308|Superiority||Mean Difference (Final Values)|0.42|Standard Error of the Mean|0.23||0.07|2-Sided|95.0|-0.03|0.87|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment."|
1591069|NCT03155178|2925308|Superiority||Mean Difference (Final Values)|0.54|Standard Error of the Mean|0.25||0.03|2-Sided|95.0|0.05|1.03||Using a Hochberg Step-up procedure the critical p value is 0.17|Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment."|
1591070|NCT03155178|2925308|Superiority||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.23||0.4|2-Sided|95.0|-0.27|0.65|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment."|
1591071|NCT03155178|2925308|Superiority||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.23||0.97|2-Sided|95.0|-0.47|0.45|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment."|
1591141|NCT03144518|2925651|Superiority|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.002||||0.671|2-Sided|90.0|0.0|0.038|||ANCOVA|controlling for pre-vaccination levels||A/Michigan 4 weeks post-vaccination|
1591399|NCT03127644|2926229|Superiority|||||||0.0586||||||Nominal p value|Log Rank||||
1591072|NCT03155178|2925308|Superiority||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.19||0.68|2-Sided|95.0|-0.3|0.45|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment."|
1591073|NCT03155178|2925308|Superiority||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.22||0.38|2-Sided|95.0|-0.63|0.24|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment."|
1591074|NCT03155178|2925309|Superiority||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.16||0.65|2-Sided|95.0|-0.25|0.39|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm^2 recovery between arms at 96-hours post-treatment."|
1591075|NCT03155178|2925309|Superiority||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.2||0.33|2-Sided|95.0|-0.2|0.58|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm^2 recovery between arms at 72-hours post-treatment."|
1591076|NCT03155178|2925309|Superiority||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.15||0.37|2-Sided|95.0|-0.45|0.17|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm^2 on the inguinal.~The null hypothesis is that there is no difference in log10 CFU /cm^2 recovery between arms at 48-hours post-treatment."|
1591077|NCT03155178|2925309|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.17||0.77|2-Sided|95.0|-0.38|0.29|||Paired t-test|||"96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm^2 recovery between arms at 96-hours post-treatment."|
1591078|NCT03155178|2925309|Superiority||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.13||0.78|2-Sided|95.0|-0.23|0.3|||Paired t-test|||"72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm^2 recovery between arms at 72-hours post-treatment."|
1591079|NCT03155178|2925309|Superiority||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.15||0.13|2-Sided|95.0|-0.53|0.07|||Paired t-test|||"48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm^2 on the abdomen.~The null hypothesis is that there is no difference in log10 CFU /cm^2 recovery between arms at 48-hours post-treatment."|
1591080|NCT03154333|2925310|Other||Risk Ratio (RR)|1.53||||0.2861|2-Sided|95.0|0.41|3.28|||Cochran-Mantel-Haenszel|Log transformation normalized the Risk Ratio (RR) estimates; the Standard Error (SE) of the estimate was obtained from confidence limits for the RR.|||
1591081|NCT03154333|2925311|Other||Risk Ratio (RR)|1.01||||0.9666|2-Sided|95.0|0.63|1.62|||Cochran-Mantel-Haenszel|Log transformation normalized the Risk Ratio (RR) estimates; the Standard Error (SE) of the estimate was obtained from confidence limits for the RR.|||
1591082|NCT03154086|2925317|Other||Ratio|0.6502||||0.157|2-Sided|90.0|0.3876|1.091|||ANOVA||||
1591083|NCT03154086|2925318|Other||Ratio|0.7325||||0.118|2-Sided|90.0|0.5267|1.019|||ANOVA||||
1591084|NCT03154086|2925319|Other||Ratio|0.8||||0.204|2-Sided|90.0|0.594|1.077|||ANOVA||||
1591085|NCT03152591|2925386|Other||Ratio LIK066/Placebo|0.79||||0.204|2-Sided|90.0|0.58|1.08|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values < LLOQ and values > ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.
1591086|NCT03152591|2925387|Other||Ratio LIK066/Placebo|0.91||||0.34|2-Sided|90.0|0.77|1.07|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.
1591087|NCT03152591|2925388|Other||Ration LIK066/Placebo|0.76||||0.008|2-Sided|90.0|0.65|0.89|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values < LLOQ and values > ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.
1591088|NCT03152591|2925389|Other||Ration LIK066/Placebo|0.69||||0.109|2-Sided|90.0|0.48|1.01|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values < LLOQ and values > ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.
1591089|NCT03152591|2925390|Other||Ratio LIK066/Placebo|0.82||||0.089|2-Sided|90.0|0.68|0.99|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values < LLOQ and values > ULOQ are imputed as LLOQ/2 and ULOQ respectively||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.
1591143|NCT03144518|2925651|Superiority|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.006||||0.438|2-Sided|90.0|0.0|0.055|||ANCOVA|Controlling for Pre-Vaccination levels||4 Weeks A/Hong-Kong|
1591090|NCT03152591|2925391|Other||Ratio LIK066/Placebo|1.15||||0.173|2-Sided|90.0|0.97|1.36|||t-test, 2 sided|Two-sided test at the 0.1 significance level|Values < LLOQ and values > ULOQ are imputed as LLOQ/2 and ULOQ respectively.||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.
1591091|NCT03152591|2925392|Other||Ratio LIK066/Placebo|1.27||||0.249|2-Sided|90.0|0.9|1.78|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.
1591092|NCT03152591|2925393|Other||Ratio LIK066/Placebo|1.25||||0.218|2-Sided|90.0|0.92|1.68|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline was analyzed using an analysis of covariance model which will include treatment as a categorical factor and log transformed baseline as a covariate.
1591093|NCT03152591|2925394|Other||Ratio LIK066/Placebo|0.88||||0.353|2-Sided|90.0|0.7|1.11|||t-test, 2 sided|Two-sided test at the 0.1 significance level|||Log transformed ratio of Day 15 to baseline in average fasting free testosterone was analyzed using an analysis of covariance model which included treatment as a categorical factor, baseline body weight and log transformed baseline average fasting free testosterone as a covariate.
1591094|NCT03151551|2925461|Superiority||Rate Difference|13.4||||0.001|2-Sided|95.0|5.3|21.6|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 & BSA≥3% were considered PASI100 responders if, and only if, PASI=0 & BSA=0 achieved at week 24.|
1591095|NCT03151551|2925462|Non-Inferiority|If the lower bound of the 2-sided 95% confidence Interval (CI) for the difference in proportions of responders on IXE minus ADA is greater than the pre-specified margin -12%, IXE will be deemed non-inferior to ADA.|Rate Difference|3.9|||||2-Sided|95.0|-4.3|12.1|||||||
1591096|NCT03151551|2925463|Superiority||Rate Difference|8.1||||0.036|2-Sided|95.0|0.5|15.8|||Regression, Logistic|||After data lock and initial analysis run, a medical inconsistency in baseline PASI data was identified (PASI=0 but BSA≥3%). The scenario was not anticipated or described in protocol or SAP. The inconsistency was resolved using medical judgment. The impacted participants had met baseline criteria for active psoriasis. Therefore, in the primary analysis, participants with baseline PASI=0 & BSA≥3% were considered PASI100 responders if, and only if, PASI=0 & BSA=0 achieved at week 24.|
1591097|NCT03151148|2925474|Superiority||Risk Ratio (RR)|0.56||||0.075|2-Sided|95.0|0.29|1.06|||Negative Binomial Regression|Negative binomial generalized linear model, adjusting for site, offset by follow-up days within the outcome measure time frame|TMT represents the numerator, placebo represents the denominator||
1591098|NCT03150719|2925478|Superiority||Mean Difference|1.1|||||2-Sided|95.0|-4.9|7.0|||||||
1591099|NCT03150719|2925479|Superiority||Mean Difference|6.7|||||2-Sided|95.0|2.5|10.9|||||||
1591100|NCT03150719|2925480|Superiority||Mean Difference|2.7|||||2-Sided|95.0|1.0|4.4|||||||
1591101|NCT03150485|2925492|Superiority|Superiority was established is the lower limit of the 95% confidence interval was above 50%.|Estimated Proportion|77.27|||||2-Sided|95.0|56.15|90.29||||||The Agresti-Coull method was used to estimate the confidence interval of the binomial proportions of subjects with less than 2 lens modifications.|
1591102|NCT03150108|2925531|Equivalence|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric Mean Ratio|1.08|||||2-Sided|90.0|0.93|1.25|||||||
1591103|NCT03150108|2925533|Equivalence|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric Mean Ratio|1.13|||||2-Sided|90.0|0.9|1.4|||||||
1591104|NCT03150108|2925539|Other|Dose proportionality|Increase in AUC0-inf per Dose Doubling|2.31|||||2-Sided|90.0|1.96|2.71|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline‑adjusted AUC0-inf using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.|
1591105|NCT03150108|2925539|Equivalence|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUC0-inf values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|1.01|||||2-Sided|90.0|0.77|1.33|||||||
1591106|NCT03150108|2925540|Other|Dose proportionality|Increase in AUC0-8 per Dose Doubling|2.23|||||2-Sided|90.0|1.98|2.51|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline‑adjusted AUC0-8 using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.|
1591107|NCT03150108|2925540|Equivalence|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUC0-8 values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|1.08|||||2-Sided|90.0|0.87|1.35|||||||
1591142|NCT03144518|2925651|Superiority|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.004||||0.516|2-Sided|90.0|0.0|0.051|||ANCOVA|controlling for pre-vaccination levels||A/Hong-Kong 16 Weeks Post-Vaccination|
1591108|NCT03150108|2925541|Other|Dose proportionality|Increase in AUClast per Dose Doubling|2.35||||||90.0|2.06|2.7|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline‑adjusted AUClast using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.|
1591109|NCT03150108|2925541|Equivalence|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed AUClast values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% CI.|Geometric mean ratio|0.99|||||2-Sided|90.0|0.8|1.23|||||||
1591110|NCT03150108|2925543|Other|Dose proportionality|Increase in Cmax per Dose Doubling|1.76|||||2-Sided|90.0|1.52|2.03|||||Linear model of log transformed PK parameters at all doses in Japanese descent, including log transformed dose, period, sequence as fixed effects, and intercept as a random effect accounting for each participant within sequence as their own control.|Dose proportionality was assessed for baseline‑adjusted Cmax using the power model. The power model assumes a linear relationship between the natural log transformed parameter and the natural log transformed dose. The fold increase in PK parameters with doubling the dose and the 90% CIs were calculated.|
1591111|NCT03150108|2925543|Equivalence|Welch's t-test with Satterthwaite's approximation to the degrees of freedom was used to compare the log transformed Cmax values of both ethnic groups at 100 mcg dose and the results were back-transformed to get the estimates for the geometric means and for the ratio of geometric means (Japanese/Caucasian), and 90% confidence interval (CI).|Geometric mean ratio|1.119|||||2-Sided|90.0|0.875|1.43|||||||
1591112|NCT03150082|2925565|Equivalence|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.||||||0.3499||||||"P value was analyzed using a nonparametric Wilcoxon signed-rank test."|Wilcoxon signed-rank test||||
1591113|NCT03150082|2925566|Equivalence|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|96.96|||||2-Sided|90.0|91.17|103.11|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.||
1591114|NCT03150082|2925567|Equivalence|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|93.16|||||2-Sided|90.0|86.09|100.82|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.||
1591115|NCT03150082|2925568|Equivalence|Bio-equivalence analysis comparing ciprofloxacin test and reference product has been presented.|Percent ratio|96.88|||||2-Sided|90.0|91.13|103.0|||||Percent ratio (GR37547 500 mg/ciprofloxacin 500 mg reference) has been presented.||
1591116|NCT03149887|2925569|Superiority|||||||0.44|||||||t-test, 2 sided||||
1591117|NCT03149887|2925570|Superiority|||||||0.76|||||||t-test, 2 sided||||
1591118|NCT03149887|2925571|Superiority|||||||0.84|||||||t-test, 2 sided||||
1591119|NCT03149887|2925572|Superiority|||||||0.53|||||||t-test, 2 sided||||
1591120|NCT03149887|2925573|Superiority|||||||0.003|||||||t-test, 2 sided||||
1591121|NCT03149887|2925574|Superiority|||||||0.07|||||||t-test, 2 sided||||
1591122|NCT03149887|2925575|Superiority|||||||0.54|||||||t-test, 2 sided||||
1591123|NCT03149887|2925576|Superiority|||||||0.66|||||||t-test, 2 sided||||
1591124|NCT03149848|2925594|Other||Ratio|1.272|||||2-Sided|90.0|1.204|1.345|||||||
1591125|NCT03149848|2925597|Other||Ratio|0.738|||||2-Sided|90.0|0.702|0.776|||||||
1591126|NCT03149848|2925598|Other||Ratio|0.825|||||2-Sided|90.0|0.761|0.895|||||||
1591127|NCT03149848|2925599|Other||Ratio|0.786|||||2-Sided|90.0|0.743|0.831|||||||
1591128|NCT03148470|2925614|Other|||||||0.642|||||||Mixed Models Analysis||||
1591129|NCT03148470|2925615|Other|||||||0.932||||||This p-value refers to the effect of stimulation (cTBS vs iTBS).|Mixed Models Analysis||||
1591130|NCT03147248|2925634|Non-Inferiority|The non-inferiority was to be concluded if the lower limit of the two-sided 95% confidence interval (CI) for the difference in the mean change from baseline of DAS28 (CRP) at Week 22 was greater that the pre-specified non-inferiority margin of -0.6.|Difference of Least square mean|0.27|||||2-Sided|95.0|0.02|0.52|||||The least squares means and standard errors, estimate of treatment difference (CT-P13 SC 120 mg - CT-P13 IV 3 mg/kg), and 2-sided 95% CI obtained from the ANCOVA model.|Primary efficacy analysis were analyzed using an ANCOVA considering the treatment as fixed effect and country, serum CRP concentration at Week 2 (≤0.6 mg/dL vs. >0.6 mg/dL), and body weight at Week 6 (≤100 kg vs. >100 kg) as covariates.|
1591131|NCT03146403|2925639|Superiority|||||||0.22|||||||Wilcoxon (Mann-Whitney)||||
1591132|NCT03146403|2925640|Superiority|||||||0.3869|||||||Log Rank||||
1591133|NCT03146403|2925641|Superiority|||||||0.3157|||||||Chi-squared||||
1591134|NCT03146403|2925642|Superiority|||||||0.645|||||||Wilcoxon (Mann-Whitney)||||
1591135|NCT03146403|2925643|Superiority|||||||0.7474|||||||Wilcoxon (Mann-Whitney)||||
1591136|NCT03144518|2925651|Superiority|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.007||||0.426|2-Sided|90.0|0.0|0.058|||ANCOVA|Controlling for pre-vaccination levels|||
1591137|NCT03144518|2925651|Superiority||Partial Eta Squared|0.0||||0.892|2-Sided|90.0|0.0|0.008|||ANCOVA|Controlling for pre-vaccination levels||B/Phuket 4 weeks post-vaccination|
1591138|NCT03144518|2925651|Superiority|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.008||||0.377|2-Sided|90.0|0.0|0.062|||ANCOVA|Controlling for pre-vaccination levels||B/Brisbane 16 weeks post-vaccination|
1591139|NCT03144518|2925651|Superiority|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.007||||0.409|2-Sided|90.0|0.0|0.057|||ANCOVA|Controlling for pre-vaccination levels||B/Brisbane 4 weeks post-vaccination|
1591140|NCT03144518|2925651|Superiority|Note: The study was not powered a priori to detect significant differences in these outcomes.|Partial Eta Squared|0.0||||0.98|2-Sided|90.0|0.0|0.0|||ANCOVA|Controlling for pre-vaccination levels||A/Michigan 16 weeks post-vaccination|
1591144|NCT03144518|2925652|Superiority||Partial Eta Squared|0.001||||0.806|2-Sided|90.0|0.0|0.031|||ANCOVA|Controlling for pre-intervention levels|||
1591145|NCT03144518|2925655|Superiority||Partial Eta Squared|0.005||||0.462|2-Sided|90.0|0.0|0.053|||ANCOVA|||PANAS Negative Affect Scores|
1591146|NCT03144518|2925655|Superiority||Partial Eta Squared|0.002||||0.697|2-Sided|90.0|0.0|0.036|||ANCOVA|Controlling for baseline levels||PANAS Positive Affect Scores|
1591147|NCT03144518|2925655|Superiority||Partial Eta Squared|0.096||||0.002|2-Sided|90.0|0.022|0.196|||ANCOVA|Controlling for pre-intervention levels||Pictorial Scale|
1591148|NCT03144518|2925655|Superiority||Partial Eta-Squared|0.04||||0.047|2-Sided|90.0|0.0|0.12|||ANCOVA|Controlling for pre-intervention scores||VAS-Arousal Scores|
1591149|NCT03144518|2925655|Superiority||Partial Eta Squared|0.079||||0.005|2-Sided|90.0|0.014|0.173||ANCOVA, controlling for pre-intervention levels|ANCOVA|ANCOVA, controlling for pre-intervention levels||VAS-Valence Scores|
1591150|NCT03144180|2925656|Equivalence|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.||||||0.403||||||The threshold for statistical significance was p = 0.05.|Chi-squared||||
1591151|NCT03144180|2925657|Equivalence|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.||||||0.0295||||||The threshold for statistical significance was p = 0.05.|Chi-squared||||
1591152|NCT03144180|2925658|Equivalence|A two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds was used to determine the sample size.|Confidence Interval for a mean|49.0|Standard Deviation|47.0|||2-Sided|95.0|15.459|82.571|||||||
1591153|NCT03143569|2925663|Other|||||||0.018|||||||Chi-squared||||
1591154|NCT03143569|2925664|Other|||||||1|||||||Fisher Exact||||
1591155|NCT03143569|2925665|Other|||||||1|||||||Fisher Exact||||
1591156|NCT03143569|2925666|Other|||||||1|||||||Fisher Exact||||
1591157|NCT03143569|2925667|Other|||||||0.45|||||||Fisher Exact||||
1591158|NCT03143166|2925668|Other||Adjusted gMean ratio Test/Reference (%)|30.61|Standard Error of the Mean|74.9|||2-Sided|90.0|23.404|40.037|||||The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).||
1591159|NCT03143166|2925669|Other||Adjusted gMean ratio Test/Reference (%)|30.59|Standard Error of the Mean|76.8|||2-Sided|90.0|23.26|40.234|||||The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).||
1591160|NCT03143166|2925670|Other||Adjusted gMean ratio Test/Reference (%)|27.56|Standard Error of the Mean|75.6|||2-Sided|90.0|21.023|36.118|||||The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).||
1591161|NCT03143166|2925671|Other||Adjusted gMean ratio Test/Reference (%)|28.02|Standard Error of the Mean|83.4|||2-Sided|90.0|20.914|37.537|||||The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).||
1591162|NCT03143166|2925672|Other||Adjusted gMean ratio Test/Reference (%)|26.37|Standard Error of the Mean|76.6|||2-Sided|90.0|20.066|34.665|||||The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).||
1591163|NCT03143166|2925673|Other||Adjusted gMean ratio Test/Reference (%)|28.85|Standard Error of the Mean|86.7|||2-Sided|90.0|21.346|38.996|||||The dispersion value standard error of the mean is actually intra individual geometric coefficient of variation (gCV) (%).||
1591164|NCT03143101|2925685|Superiority||Mean Difference (Net)|32.7|||<|0.001|2-Sided|95.0|14.4|47.8||p-value is calculated from the CMH test adjusting for the prior influenza vaccination status.|Cochran-Mantel-Haenszel||||
1591165|NCT03143101|2925689|Superiority||Mean Difference (Net)|18.1||||0.006|2-Sided|95.0|4.8|30.9||p-value is calculated from the Cochran-Mantel-Haenszel (CMH) test adjusting for the prior influenza vaccination status.|Cochran-Mantel-Haenszel||||
1591166|NCT03141307|2925722|Equivalence|95% margin|||||<|0.05||||||a priori threshold for statistical significance set for p < .05|t-test, 2 sided||||
1591167|NCT03141307|2925723|Equivalence|95% margin|||||=|0||||||a prior threshold for statistical significance set for p < .05.|t-test, 2 sided||||
1591168|NCT03141307|2925724|Equivalence|95% margin|||||=|0||||||a priori threshold for statistical significance set for p < .05|t-test, 2 sided||||
1591169|NCT03141307|2925725|Equivalence|95% margin|||||=|0||||||a priori threshold for statistical significance set for p < .05|t-test, 2 sided||||
1591170|NCT03141307|2925726|Equivalence|95% margin|||||<|0.05||||||a priori threshold for statistical significance set for p < .05|t-test, 2 sided||||
1591171|NCT03141307|2925727|Equivalence|95% margin|||||<|0.001||||||a priori threshold for statistical significance set for p < .05|t-test, 2 sided||||
1591172|NCT03141086|2925744|Superiority||Mean Difference (Net)|0.879||||0.2026|2-Sided|95.0|-1.268|3.026|||Mixed Models Analysis|||9.5 hours post dose|
1591173|NCT03141086|2925744|Superiority||Mean Difference (Net)|1.576||||0.0811|2-Sided|95.0|-0.697|3.848|||Mixed Models Analysis|||7.5 hours post dose|
1591174|NCT03141086|2925744|Superiority||Mean Difference (Net)|1.975||||0.0919|2-Sided|95.0|-1.024|4.973|||Mixed Models Analysis|||5.5 hours post dose|
1591175|NCT03141086|2925744|Superiority||Mean Difference (Final Values)|2.866||||0.0607|2-Sided|95.0|-0.821|6.553|||Mixed Models Analysis|||3.5 hours post dose|
1591176|NCT03141086|2925745|Superiority||Mean Difference (Final Values)|1.711||||0.1272|2-Sided|95.0|-1.34|4.762|||ANOVA||||
1591177|NCT03140631|2925746|Superiority|||||||0.74|||||||Fisher Exact|||number of participants who experienced a vascular access site complication at 90 days|
1591178|NCT03140631|2925747|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1591179|NCT03139604|2925767|Other||Odds Ratio (OR)|1.45||||0.0782|2-Sided|95.0|0.959|2.204||Not adjusted for multiplicity with interim and final analyses|Cochran-Mantel-Haenszel|||binomial distribution|
1591180|NCT03139578|2925768|Non-Inferiority|Non-inferiority margin of 0.1 was used. If the upper limit of 95% confidence interval was lower than a non-inferiority margin of 0.1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.001|||||2-Sided|95.0|-0.012|0.009|||||||
1591181|NCT03139578|2925768|Non-Inferiority|Non-inferiority margin of 0.1 was used. If the upper limit of 95% confidence interval was lower than a non-inferiority margin of 0.1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.002|||||2-Sided|95.0|-0.009|0.012|||||||
1591283|NCT03135015|2926022|Other|||||||0.9681|||||||t-test, 2 sided||||
1591182|NCT03139578|2925769|Non-Inferiority|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.1|||||2-Sided|95.0|-0.6|0.4|||||||
1591183|NCT03139578|2925769|Non-Inferiority|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.0|||||2-Sided|95.0|-0.5|0.5|||||||
1591184|NCT03139578|2925770|Non-Inferiority|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||2-Sided|95.0|-0.2|0.3|||||||
1591185|NCT03139578|2925770|Non-Inferiority|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||2-Sided|95.0|-0.1|0.4|||||||
1591186|NCT03139578|2925771|Non-Inferiority|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.1|||||2-Sided|95.0|-0.2|0.5|||||||
1591187|NCT03139578|2925771|Non-Inferiority|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|-0.1|||||2-Sided|95.0|-0.4|0.3|||||||
1591188|NCT03139578|2925772|Non-Inferiority|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.0|||||2-Sided|95.0|-0.5|0.5|||||||
1591189|NCT03139578|2925772|Non-Inferiority|Non-inferiority margin of -1 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of -1, then non-inferiority of Test relative to Control was concluded.|Least square mean difference|0.2|||||2-Sided|95.0|-0.3|0.7|||||||
1591190|NCT03139578|2925773|Equivalence|Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D.|Proportion (%)|100.0|||||2-Sided|97.5|90.5|100.0|||||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.||
1591191|NCT03139578|2925773|Equivalence|Equivalence margin of 80% was used for the lens power requirement difference within ±0.25 D.|Proportion (%)|100.0|||||2-Sided|97.5|90.5|100.0|||||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.||
1591192|NCT03139578|2925773|Equivalence|Equivalence margin of 70% was used for no difference in lens power requirement.|Proportion (%)|83.3|||||2-Sided|97.5|68.3|92.1|||||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.||
1591193|NCT03139578|2925773|Equivalence|Equivalence margin of 70% was used for no difference in lens power requirement.|Proportion (%)|93.8|||||2-Sided|97.5|81.1|98.1|||||Lens power requirement difference was calculated as Test minus Control. Then the proportion of eyes with similar lens power requirements (no difference or difference within ±0.25D) was calculated.||
1591194|NCT03139578|2925774|Non-Inferiority|Non-inferiority margin of 0.625 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of 0.625, then non-inferiority of Test relative to Control was concluded.|Cumulative Odds Ratio|0.93|||||2-Sided|95.0|0.34|2.52|||||Cumulative odds ratio was calculated as Test over Control.||
1591195|NCT03139578|2925774|Non-Inferiority|Non-inferiority margin of 0.625 was used. If the lower limit of 95% confidence interval was greater than a non-inferiority margin of 0.625, then non-inferiority of Test relative to Control was concluded.|Cumulative Odds Ratio|1.18|||||2-Sided|95.0|0.46|3.06|||||Cumulative odds ratio was calculated as Test over Control.||
1591196|NCT03138876|2925810|Superiority|||||||0.0005|||||||Wilcoxon (Mann-Whitney)||||
1591197|NCT03138577|2925821|Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1591198|NCT03138577|2925822|Other||Median Difference (Final Values)|0.0||||1|2-Sided||||||Sign test||||
1591199|NCT03138577|2925822|Other||Median Difference (Final Values)|-1.0||||0.01|2-Sided||||||Sign test||||
1591200|NCT03138577|2925823|Other||||||||||||||||||Dose response data was fit with a non-parametric smoothing technique for locally weighted regression (lowess) to produce a dose response curve.
1591201|NCT03138577|2925824|Other||||||||||||||||||Dose response data was fit with a non-parametric smoothing technique for locally weighted regression (lowess) to produce a dose response curve.
1591202|NCT03138577|2925825|Other||Median Difference (Final Values)|0.0||||1|2-Sided||||||Sign test||||
1591203|NCT03138577|2925825|Other||Median Difference (Final Values)|7.5||||0.01|2-Sided||||||Sign test||||
1591204|NCT03138577|2925826|Other||||||||||||||||||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.
1591205|NCT03138577|2925827|Other||||||||||||||||||Counts and percentages of cases with paralysis were calculated separately for each volume of local anesthetic.
1591206|NCT03137784|2925832|Other|Treatment difference|Linear Mixed Model (LMM)|-0.11||||0.163|2-Sided|95.0|-0.27|0.05|||Linear Mixed Model||||
1591207|NCT03137784|2925832|Other|Treatment difference|Linear Mixed Model (LMM)|-0.15||||0.053|2-Sided|95.0|-0.31|0.0|||Linear Mixed Model||||
1591208|NCT03137784|2925833|Other|Treatment difference|Linear Mixed Model (LMM)|29.37|||<|0.001|2-Sided|95.0|23.47|35.26|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates||
1591209|NCT03137784|2925833|Other|Treatment difference|Linear Mixed Model (LMM)|30.95|||<|0.001|2-Sided|95.0|25.07|36.82|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates||
1591210|NCT03137784|2925834|Other|Treatment difference|Linear Mixed Model (LMM)|24.29|||<|0.001|2-Sided|95.0|17.99|30.59|||Linear Mixed Model||||
1591211|NCT03137784|2925834|Other|Treatment difference|Linear Mixed Model (LMM)|25.51|||<|0.001|2-Sided|95.0|19.22|31.79|||Linear Mixed Model||LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates||
1591212|NCT03137784|2925836|Other|Treatment difference|Linear Mixed Model (LMM)|0.058||||0.006|2-Sided|95.0|0.017|0.099|||Linear Mixed Model||||
1591213|NCT03137784|2925836|Other|Treatment difference|Linear Mixed Model (LMM)|0.036||||0.079|2-Sided|95.0|-0.004|0.077|||Linear Mixed Model||||
1591214|NCT03137784|2925837|Other|Treatment difference|Linear Mixed Model (LMM)|0.174|||<|0.001|2-Sided|95.0|0.137|0.211|||Linear Mixed Model||||
1591215|NCT03137784|2925837|Other|Treatment difference|Linear Mixed Model (LMM)|0.164|||<|0.001|2-Sided|95.0|0.127|0.201|||Linear Mixed Model||||
1591216|NCT03137784|2925838|Other|Treatment difference|Linear Mixed Model (LMM)|0.146|||<|0.001|2-Sided|95.0|0.112|0.179|||Linear Mixed Model||||
1591217|NCT03137784|2925838|Other|Treatment difference|Linear Mixed Model (LMM)|0.139|||<|0.001|2-Sided|95.0|0.106|0.173|||Linear Mixed Model||||
1591218|NCT03137784|2925839|Other|Treatment difference|Linear Mixed Model (LMM)|0.179|||<|0.001|2-Sided|95.0|0.144|0.215|||Linear Mixed Model||||
1591219|NCT03137784|2925839|Other|Treatment difference|Linear Mixed Model (LMM)|0.176|||<|0.001|2-Sided|95.0|0.141|0.212|||Linear Mixed Model||||
1591220|NCT03137784|2925840|Other|Treatment difference|Linear Mixed Model (LMM)|0.168|||<|0.001|2-Sided|95.0|0.129|0.206|||Linear Mixed Model||||
1591221|NCT03137784|2925840|Other|Treatment difference|Linear Mixed Model (LMM)|0.165|||<|0.001|2-Sided|95.0|0.127|0.203|||Linear Mixed Model||||
1591222|NCT03137784|2925841|Other||Linear Mixed Model (LMM)|0.09|||<|0.001|2-Sided|95.0|0.047|0.132|||Linear Mixed Model||||
1591223|NCT03137784|2925841|Other|Treatment difference|Linear Mixed Model (LMM)|0.089|||<|0.001|2-Sided|95.0|0.047|0.132|||Linear Mixed Model||||
1591224|NCT03137173|2925846|Non-Inferiority|Non-inferiority was assessed by the two-sided 95% CI of the between-group difference (ceftobiprole minus vancomycin plus aztreonam) using a 10% non-inferiority margin in the CE populations. Difference was computed using the CMH weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|2.7|||||2-Sided|95.0|-0.3|5.6|||||||
1591225|NCT03137173|2925847|Non-Inferiority|Non-inferiority was assessed by the two-sided 95% CI of the between-group difference (ceftobiprole minus vancomycin+aztreonam) using a 10% non-inferiority margin in the ITT population. Difference was computed using the CMH weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|1.0|||||2-Sided|95.0|-3.5|5.6|||||||
1591226|NCT03137173|2925848|Non-Inferiority|Non-inferiority was assessed by the two-sided 95% confidence interval (CI) of the between-group difference (ceftobiprole minus vancomycin+aztreonam) using a 10% non-inferiority margin in the ITT population. Difference was computed using the Cochran-Mantel-Haenszel (CMH) weights method, adjusted for geographical region and actual type of ABSSSI.|Risk Difference (RD)|3.3|||||2-Sided|95.0|-1.2|7.8|||||||
1591227|NCT03136861|2925849|Superiority||Odds Ratio (OR)|1.75||||0.0466|2-Sided|95.0|1.01|3.04|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR).||BASDAI Score <4 at Week 8|
1591228|NCT03136861|2925850|Superiority||Odds Ratio (OR)|1.72||||0.072|2-Sided|95.0|0.95|3.1|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR)||Nocturnal Spinal Pain Score|
1591229|NCT03136861|2925850|Superiority||Odds Ratio (OR)|2.38||||0.0043|2-Sided|95.0|1.31|4.31|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR)||Total Spinal Pain Score <4 at Week 8|
1591230|NCT03136861|2925850|Superiority||Odds Ratio (OR)|1.89||||0.0264|2-Sided|95.0|1.08|3.33|||Regression, Logistic|Logistic regression model: logit (proportion) = treatment + stratification factor of prior exposure to TNF inhibitors (i.e. TNF-naïve or TNFα-IR).||Average Spinal Pain Score <4 at Week 8|
1591231|NCT03136484|2925911|Superiority||Treatment difference|-0.49|||<|0.0001|2-Sided|95.0|-0.65|-0.33|||ANCOVA||Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo|The responses were analysed using an ANCOVA with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.|
1591232|NCT03136484|2925911|Non-Inferiority|The non-inferiority p-value was calculated as two times the one-sided p-value from a t-distributed test statistic comparing the treatment contrast with 0.3 rather than zero as in a superiority test.|Treatment difference|-0.49|||<|0.0001|2-Sided|95.0|-0.65|-0.33|||ANCOVA||Semaglutide + canagliflozin placebo vs Canagliflozin + semaglutide placebo|The responses were analysed using an analysis of covariance (ANCOVA) with treatment, region and stratification factor as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including region and stratification factor as categorical effects and data from baseline and all previous visits as covariates.|
1591233|NCT03136107|2925985|Equivalence|Statistical criterion defined in ISO 24444:2010 is that the 95 %CI is within ±17 % of the mean SPF||||||||||||||||CI % values (which is the percentage that half the 95 % CI represents of the mean values).|Test product CI of ±16.4% and reference product CI of ±16.6% of the mean SPF.
1591234|NCT03135899|2925991|Other||Hazard Ratio (HR)|2.59|||||2-Sided|95.0|1.5|4.47|||||BI 443651 1200 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.|
1591235|NCT03135899|2925991|Other||Hazard Ratio (HR)|2.08|||||2-Sided|95.0|1.22|3.53|||||BI 443651 400 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.|
1591236|NCT03135899|2925991|Other||Hazard Ratio (HR)|2.27|||||2-Sided|95.0|1.31|3.95|||||BI 443651 100 μg is compared to placebo.|The cox proportional hazard model included treatment and period as fixed effect and patient baseline as covariate. No hypothesis was tested. The patient baseline was obtained by calculating the median of the period baselines for each patient. A hazard ratio greater than 1 gives that active treatment is not-inferior to placebo.|
1591237|NCT03135899|2925993|Other||Geometric Mean Ratio|0.845|Standard Error of the Mean|1.169|||2-Sided|90.0|0.651|1.095|||||BI 443651 1200 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included ‘treatment’ and ‘period’ as fixed effects, ‘patient’ as a random effect, and ‘period baseline’ as well as ‘patient baseline’ as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.|
1591238|NCT03135899|2925993|Other||Geometric Mean Ratio|0.926|Standard Error of the Mean|1.168|||2-Sided|90.0|0.715|1.199|||||BI 443651 400 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included ‘treatment’ and ‘period’ as fixed effects, ‘patient’ as a random effect, and ‘period baseline’ as well as ‘patient baseline’ as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.|
1591239|NCT03135899|2925993|Other||Geometric Mean Ratio|0.77|Standard Error of the Mean|1.168|||2-Sided|90.0|0.595|0.977|||||BI 443651 100 μg is compared to placebo. Standard error of the mean is actually geometric standard error.|The mixed effects model included ‘treatment’ and ‘period’ as fixed effects, ‘patient’ as a random effect, and ‘period baseline’ as well as ‘patient baseline’ as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.|
1591240|NCT03135899|2925995|Other||Mean Difference (Final Values)|-0.157|Standard Error of the Mean|0.066|||2-Sided|90.0|-0.266|-0.047|||||BI 443651 1200 μg is compared to placebo.|The mixed effects model included ‘treatment’ and ‘period’ as fixed effects, ‘patient’ as a random effect, and ‘period baseline’ as well as ‘patient baseline’ as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.|
1591241|NCT03135899|2925995|Other||Mean Difference (Final Values)|-0.037|Standard Error of the Mean|0.064|||2-Sided|90.0|-0.144|0.07|||||BI 443651 400 μg is compared to placebo.|The mixed effects model included ‘treatment’ and ‘period’ as fixed effects, ‘patient’ as a random effect, and ‘period baseline’ as well as ‘patient baseline’ as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.|
1591242|NCT03135899|2925995|Other||Mean Difference (Final Values)|0.059|Standard Error of the Mean|0.064|||2-Sided|90.0|-0.048|0.165|||||BI 443651 100 μg is compared to placebo.|The mixed effects model included ‘treatment’ and ‘period’ as fixed effects, ‘patient’ as a random effect, and ‘period baseline’ as well as ‘patient baseline’ as covariates. No hypothesis was tested. The patient baseline was obtained by calculating the mean of the period baselines for each patient. Covariance structure variance component (VC) was used for random subject effect.|
1591243|NCT03135548|2925997|Other|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.015|||||2-Sided|95.0|-0.213|0.252|||||||
1591244|NCT03135548|2925997|Other|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|-0.143|||||2-Sided|95.0|-0.346|0.049|||||||
1591245|NCT03135548|2925998|Other|No formal hypothesis testing was performed in this trial.|Mean Difference (Final Values)|-5.82|||||2-Sided|95.0|-28.35|16.7|||||||
1591246|NCT03135548|2925998|Other|No formal hypothesis testing was performed in this trial.|Mean Difference (Final Values)|7.24|||||2-Sided|95.0|-20.01|34.48|||||||
1591247|NCT03135548|2925999|Other|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.115|||||2-Sided|95.0|-0.116|0.348|||||Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.||
1591248|NCT03135548|2925999|Other|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|-0.095|||||2-Sided|95.0|-0.289|0.086|||||Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.||
1591249|NCT03135548|2926001|Other|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.078|||||2-Sided|95.0|-0.19|0.338|||||Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.||
1591250|NCT03135548|2926001|Other|No formal hypothesis testing was performed in this trial.|Risk Difference (RD)|0.078|||||2-Sided|95.0|-0.19|0.338|||||Unadjusted absolute risk difference versus placebo was calculated as the difference in the observed proportion of patients with ppPASI50 at Week 16 for each treatment scenario, for the FAS.||
1591251|NCT03135431|2926007|Superiority||Mean Difference (Net)|-9.17||||0.77|2-Sided|95.0|-72.5|54.17|||t-test, 2 sided|||Analysis preformed as categorical and categorical variable. Both analyzes had the same conclusion.|
1591252|NCT03135431|2926008|Superiority||Mean Difference (Final Values)|-11.21|||||2-Sided|95.0|-14.1|-8.3|||||Evidence to suggest salpingecotomy procedure had a longer operation time than a tubal ligation.||
1591253|NCT03135431|2926009|Non-Inferiority|<=.5g/dl difference in the decrease in hemoglobin was considered equivalent as 1 unit of blood typically raises the hemoglobin by 1g/dl and would be a clinical significant difference.|Mean Difference (Final Values)|-0.04121||||0.08|1-Sided|95.0||0.0712|||t-test, 1 sided|||Assuming that a difference of 0.5 g/dl in the drop in hemoglobin between study arms would be considered as equivalent, and assuming a common standard deviation of 1.1 based on previous studies of cesarean deliveries deliveries , the study would have 80% power to test for non-inferiority with 60 participants in each arm (120 total).|Based on new data from a retrospective study preformed at Mayo Clinic sites an additional power calculation was preformed. Based on the new information, our study was well powered (84%) to assess our primary aim with 38 participants (18 salpingectomy, 20 BTL); therefore, we discontinued recruitment and completed the study with the accrued subjects.
1591254|NCT03135015|2926015|Other||Percentage Change from Control|-19.64||||0.4283|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591255|NCT03135015|2926015|Other||Percentage Change from Control|-46.43||||0.0303|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591256|NCT03135015|2926016|Other||Percentage Change from Control|-55.81||||0.1631|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591257|NCT03135015|2926016|Other||Percentage Change from Control|-82.11||||0.0372|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591258|NCT03135015|2926016|Other||Percentage Change from Control|-36.45||||0.0391|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591259|NCT03135015|2926016|Other||Percentage Change from Control|-41.82||||0.0261|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591260|NCT03135015|2926017|Other||Percentage Change from Control|-41.8||||0.0455|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591261|NCT03135015|2926017|Other||Percentage Change from Control|-39.96||||0.0266|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591262|NCT03135015|2926017|Other||Percentage Change from Control|-30.32||||0.0887|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591263|NCT03135015|2926017|Other||Percentage Change from Control|-31.36||||0.0788|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591264|NCT03135015|2926018|Other||Percentage Change from Control|-46.19||||0.0125|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591265|NCT03135015|2926018|Other||Percentage Change from Control|-53.27||||0.0016|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591266|NCT03135015|2926018|Other||Percentage Change from Control|-33.21||||0.0058|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591267|NCT03135015|2926018|Other||Percentage Change from Control|-36.28||||0.0034|2-Sided||||||t-test, 2 sided|||Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|
1591268|NCT03135015|2926019|Other||Percentage Change from Control|-25.02||||0.0391|2-Sided||||||t-test, 2 sided||||
1591269|NCT03135015|2926019|Other||Percentage Change from Control|-24.22||||0.0098|2-Sided||||||t-test, 2 sided||||
1591270|NCT03135015|2926020|Other||Percentage Change from Control|-21.09||||0.0374|2-Sided||||||t-test, 2 sided||||
1591271|NCT03135015|2926021|Other||Mean Difference (Net)|2.526|Standard Error of the Mean|5.813|||2-Sided||||||||Percentage Change from Control||
1591272|NCT03135015|2926021|Other||Mean Difference (Net)|-13.293|Standard Error of the Mean|9.664|||2-Sided||||||||Percentage Change from Control||
1591273|NCT03135015|2926021|Other||Mean Difference (Net)|12.755|Standard Error of the Mean|8.489|||2-Sided||||||||Percentage Change from Control||
1591274|NCT03135015|2926021|Other||Mean Difference (Net)|-11.604|Standard Error of the Mean|6.722|||2-Sided||||||||Percentage Change from Control||
1591275|NCT03135015|2926021|Other|||||||0.1684|||||||t-test, 2 sided||||
1591276|NCT03135015|2926021|Other|||||||0.0111|||||||t-test, 2 sided||||
1591277|NCT03135015|2926022|Other||Mean Difference (Net)|-12.929|Standard Error of the Mean|14.282|||2-Sided||||||||Percentage Change from Control||
1591278|NCT03135015|2926022|Other||Mean Difference (Net)|-13.738|Standard Error of the Mean|13.463|||2-Sided||||||||Percentage Change from Control||
1591279|NCT03135015|2926022|Other||Mean Difference (Net)|-10.362|Standard Error of the Mean|10.387|||2-Sided||||||||Percentage Change from Control||
1591280|NCT03135015|2926022|Other||Mean Difference (Net)|-13.123|Standard Error of the Mean|8.55|||2-Sided||||||||Percentage Change from Control||
1591281|NCT03135015|2926022|Other|||||||0.3738|||||||t-test, 2 sided||||
1591282|NCT03135015|2926022|Other|||||||0.1022|||||||t-test, 2 sided||||
1591291|NCT03135015|2926026|Other||Percentage Change from Control|9.32||||0.5485|2-Sided||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey’s test to adjust for multiple comparisons.|
1591292|NCT03135015|2926026|Other||Percentage Change from Control|-8.53||||0.5827|2-Sided||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey’s test to adjust for multiple comparisons.|
1591293|NCT03135015|2926027|Other|||||||0.5485|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey’s test to adjust for multiple comparisons.|
1591294|NCT03135015|2926027|Other|||||||0.5827|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey’s test to adjust for multiple comparisons.|
1591295|NCT03135015|2926028|Other|||||||0.0519|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey’s test to adjust for multiple comparisons|
1591296|NCT03135015|2926028|Other|||||||0.1146|||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey’s test to adjust for multiple comparisons|
1591297|NCT03135015|2926029|Other||Percentage Change from Control|-8.95|||||2-Sided|||||||||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.|
1591298|NCT03135015|2926029|Other||Percentage Change from Control|-17.42||||0.0519|2-Sided||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey’s test to adjust for multiple comparisons.|
1591299|NCT03135015|2926029|Other||Percentage Change from Control|-14.09||||0.1146|2-Sided||||||t-test, 2 sided|||The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey’s test to adjust for multiple comparisons.|
1591300|NCT03134222|2926075|Superiority|||||||0.6407|||||||Cochran-Mantel-Haenszel||||
1591301|NCT03134222|2926075|Superiority|||||||0.7456|||||||Cochran-Mantel-Haenszel||||
1591302|NCT03134222|2926076|Superiority|||||||0.3293|||||||Cochran-Mantel-Haenszel||||
1591303|NCT03134222|2926076|Superiority|||||||0.8869|||||||Cochran-Mantel-Haenszel||||
1591304|NCT03134222|2926077|Superiority|||||||0.3047|||||||Mixed-effect repeated measures model||||
1591305|NCT03134222|2926077|Superiority|||||||0.75|||||||Mixed-effect repeated measures model||||
1591306|NCT03133767|2926080|Superiority|||||||0.509|||||||Chi-squared||||
1591307|NCT03133767|2926081|Superiority|||||||0.361|||||||Chi-squared||||
1591308|NCT03133767|2926082|Superiority|||||||0.202|||||||Chi-squared||||
1591309|NCT03133767|2926083|Superiority|||||||0.027|||||||Wilcoxon (Mann-Whitney)||||
1591310|NCT03133767|2926084|Superiority|||||||0.608|||||||Wilcoxon (Mann-Whitney)||||
1591311|NCT03131895|2926130|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0031||||0.9778|2-Sided|90.0|0.9458|1.0638|||ANOVA||||
1591312|NCT03131895|2926130|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0335||||0.4163|2-Sided|90.0|0.9733|1.0975|||ANOVA||||
1591313|NCT03131895|2926131|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0353||||0.3896|2-Sided|90.0|0.9719|1.1029|||ANOVA||||
1591314|NCT03131895|2926131|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.039||||0.3209|2-Sided|90.0|0.9792|1.1024|||ANOVA||||
1591315|NCT03131895|2926132|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90% CIs on the original scale.|LS mean ratio|1.0185||||0.892|2-Sided|90.0|0.9334|1.1113|||ANOVA||||
1591316|NCT03131895|2926132|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as a fixed effect and subject nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates and 90 percent (%) confidence intervals (CIs) on the original scale.|Least square (LS) mean ratio|1.0436||||0.5535|2-Sided|90.0|0.9453|1.1521|||ANOVA||||
1591317|NCT03131687|2926142|Other||Mean Difference (Final Values)|-8.8|||<|0.001|2-Sided|95.0|-11.3|-6.4|||Mixed Models Analysis||||
1591318|NCT03131687|2926142|Other||Mean Difference (Final Values)|-6.0|||<|0.001|2-Sided|95.0|-8.4|-3.7|||Mixed Models Analysis||||
1591319|NCT03131687|2926142|Other||Mean Difference (Final Values)|-3.8|||<|0.001|2-Sided|95.0|-6.1|-1.5|||Mixed Models Analysis||||
1591320|NCT03131687|2926142|Other||Mean Difference (Final Values)|-0.7|||<|0.539|2-Sided|95.0|-3.1|1.6|||Mixed Models Analysis||||
1591321|NCT03131687|2926143|Other||Mean Difference (Final Values)|-0.3||||0.067|2-Sided|95.0|-0.6|0.0|||Mixed Models Analysis||||
1591322|NCT03131687|2926143|Other||Mean Difference (Final Values)|-0.2||||0.145|2-Sided|95.0|-0.5|0.1|||Mixed Models Analysis||||
1591323|NCT03131687|2926143|Other||Mean Difference (Final Values)|-0.2||||0.194|2-Sided|95.0|-0.5|0.1|||Mixed Models Analysis||||
1591324|NCT03131687|2926143|Other||Mean Difference (Final Values)|0.0||||0.919|2-Sided|95.0|-0.3|0.3|||Mixed Models Analysis||||
1591325|NCT03131687|2926144|Other||Median Difference (Final Values)|-1.1|||<|0.001|2-Sided|95.0|-1.5|-0.7|||Mixed Models Analysis||||
1591326|NCT03131687|2926144|Other||Mean Difference (Final Values)|-1.0|||<|0.001|2-Sided|95.0|-1.4|-0.6|||Mixed Models Analysis||||
1591327|NCT03131687|2926144|Other||Mean Difference (Final Values)|-0.8|||<|0.001|2-Sided|95.0|-1.1|-0.4|||Mixed Models Analysis||||
1591328|NCT03131687|2926144|Other||Mean Difference (Final Values)|-0.3|||<|0.164|2-Sided|95.0|-0.7|0.1|||Mixed Models Analysis||||
1591329|NCT03131687|2926145|Other||Median Difference (Final Values)|-0.6|||<|0.001|2-Sided|95.0|-0.9|-0.3|||Mixed Models Analysis||||
1591330|NCT03131687|2926145|Other||Median Difference (Final Values)|-0.5|||<|0.001|2-Sided|95.0|-0.9|-0.2|||Mixed Models Analysis||||
1591331|NCT03131687|2926145|Other||Mean Difference (Final Values)|-0.4|||<|0.01|2-Sided|95.0|-0.7|-0.1|||Mixed Models Analysis||||
1591332|NCT03131687|2926145|Other||Mean Difference (Final Values)|-0.1|||<|0.565|2-Sided|95.0|-0.4|0.2|||Mixed Models Analysis||||
1591333|NCT03131687|2926146|Other||Mean Difference (Final Values)|0.0||||0.325|2-Sided|95.0|0.0|0.1|||Mixed Models Analysis||||
1591334|NCT03131687|2926146|Other||Mean Difference (Final Values)|0.0||||0.536|2-Sided|95.0|-0.1|0.1|||Mixed Models Analysis||||
1591335|NCT03131687|2926146|Other||Mean Difference (Final Values)|0.0||||0.903|2-Sided|95.0|-0.1|0.1|||Mixed Models Analysis||||
1591336|NCT03131687|2926146|Other||Mean Difference (Final Values)|0.0||||0.396|2-Sided|95.0|-0.1|0.0|||Mixed Models Analysis||||
1591337|NCT03131687|2926147|Other||Mean Difference (Final Values)|-73.0|||<|0.001|2-Sided|95.0|-90.9|-55.2|||Mixed Models Analysis||||
1591338|NCT03131687|2926147|Other||Odds Ratio (OR)|-76.3|||<|0.001|2-Sided|95.0|-93.3|-59.2|||Mixed Models Analysis||||
1591339|NCT03131687|2926147|Other||Mean Difference (Final Values)|-56.2|||<|0.001|2-Sided|95.0|-72.9|-39.5|||Mixed Models Analysis||||
1591340|NCT03131687|2926147|Other||Mean Difference (Final Values)|-22.4|||<|0.01|2-Sided|95.0|-39.4|-5.3|||Mixed Models Analysis||||
1591341|NCT03131687|2926148|Other||||||<|0.001|||||||Regression, Logistic||||
1591342|NCT03131687|2926148|Other||||||<|0.001|||||||Regression, Logistic||||
1591343|NCT03131687|2926148|Other||||||<|0.001|||||||Regression, Logistic||||
1591344|NCT03131687|2926148|Other||||||<|0.008|||||||Regression, Logistic||||
1591345|NCT03131687|2926149|Other||||||<|0.001|||||||Regression, Logistic||||
1591346|NCT03131687|2926149|Other||||||<|0.001|||||||Regression, Logistic||||
1591347|NCT03131687|2926149|Other||||||<|0.001|||||||Regression, Logistic||||
1591348|NCT03131687|2926149|Other||||||<|0.03|||||||Regression, Logistic||||
1591349|NCT03131687|2926150|Other|||||||0.003|||||||Regression, Logistic||||
1591350|NCT03131687|2926150|Other|||||||0.003|||||||Regression, Logistic||||
1591351|NCT03131687|2926150|Other|||||||0.036|||||||Regression, Logistic||||
1591352|NCT03131687|2926150|Other|||||||0.193|||||||Regression, Logistic||||
1591353|NCT03131687|2926151|Other||||||<|0.001|||||||Regression, Logistic||||
1591354|NCT03131687|2926151|Other||||||<|0.001|||||||Regression, Logistic||||
1591355|NCT03131687|2926151|Other||||||<|0.002|||||||Regression, Logistic||||
1591356|NCT03131687|2926151|Other||||||<|0.053|||||||Regression, Logistic||||
1591357|NCT03131687|2926152|Other||Median Difference (Final Values)|-10.9|||<|0.001|2-Sided|95.0|-13.3|-8.6|||Mixed Models Analysis||||
1591358|NCT03131687|2926152|Other||Mean Difference (Final Values)|-8.3|||<|0.001|2-Sided|95.0|-10.5|-6.0|||Mixed Models Analysis||||
1591359|NCT03131687|2926152|Other||Mean Difference (Final Values)|-4.4|||<|0.001|2-Sided|95.0|-6.6|-2.3|||Mixed Models Analysis||||
1591360|NCT03131687|2926152|Other||Mean Difference (Final Values)|-0.5|||<|0.655|2-Sided|95.0|-2.7|1.7|||Mixed Models Analysis||||
1591361|NCT03131687|2926153|Other||Mean Difference (Final Values)|-2.1|||<|0.001|2-Sided|95.0|-2.4|-1.7|||Mixed Models Analysis||||
1591362|NCT03131687|2926153|Other||Mean Difference (Final Values)|-1.9|||<|0.001|2-Sided|95.0|-2.3|-1.5|||Mixed Models Analysis||||
1591363|NCT03131687|2926153|Other||Mean Difference (Final Values)|-1.7|||<|0.001|2-Sided|95.0|-2.0|-1.3|||Mixed Models Analysis||||
1599058|NCT02858401|2938157|Other|||||||1|||||||Fisher Exact||||
1591364|NCT03131687|2926153|Other||Mean Difference (Final Values)|-0.8|||<|0.001|2-Sided|95.0|-1.1|-0.4|||Mixed Models Analysis||||
1591365|NCT03131687|2926154|Other||Median Difference (Final Values)|-2.5|||<|0.001|2-Sided|95.0|-2.9|-2.0|||Mixed Models Analysis||||
1591366|NCT03131687|2926154|Other||Median Difference (Final Values)|-2.1|||<|0.001|2-Sided|95.0|-2.5|-1.6|||Mixed Models Analysis||||
1591367|NCT03131687|2926154|Other||Median Difference (Final Values)|-1.7|||<|0.001|2-Sided|95.0|-2.2|-1.3|||Mixed Models Analysis||||
1591368|NCT03131687|2926154|Other||Mean Difference (Final Values)|-0.8|||<|0.001|2-Sided|95.0|-1.2|-0.4|||Mixed Models Analysis||||
1591369|NCT03131687|2926155|Other||Posterior Mean Difference|-1.67|Standard Deviation|0.15|||2-Sided||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.||
1591370|NCT03131687|2926155|Other||Posterior Mean Difference|-1.62|Standard Deviation|0.15|||2-Sided||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.||
1591371|NCT03131687|2926155|Other||Posterior Mean Difference|-1.49|Standard Deviation|0.15|||2-Sided||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.||
1591372|NCT03131687|2926155|Other||Posterior Mean Difference|-0.89|Standard Deviation|0.15|||2-Sided||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.||
1591373|NCT03131687|2926156|Other||Posterior Mean Difference|-1.89|Standard Deviation|0.17|||2-Sided||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.||
1591374|NCT03131687|2926156|Other||Posterior Mean Difference|-1.83|Standard Deviation|0.17|||2-Sided||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.||
1591375|NCT03131687|2926156|Other||Posterior Mean Difference|-1.67|Standard Deviation|0.17|||2-Sided||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.||
1591376|NCT03131687|2926156|Other||Posterior Mean Difference|-1.0|Standard Deviation|0.17|||2-Sided||||||||Statistics are estimated from a Bayesian hierarchical logistic dose response model along with a titrated integrated two-component prediction model to estimate missing values.||
1591377|NCT03131596|2926157|Superiority||||||>|0.05|||||||Chi-squared||||
1591378|NCT03131596|2926158|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1591379|NCT03131596|2926159|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1591380|NCT03131596|2926160|Superiority|||||||0.012||||||The p-value is not adjusted and a p-value of < 0.05 is considered statistically significant.|Chi-squared|||200 patients were eligible and randomised in a 1:1 fashion. 9 patients did not complete the full protocol, resulting in 94 cases in the balloon group and 97 cases in the control group included in the final analysis. Intention-to-treat analysis was conducted.The null hypothesis is the percentage of the patients with reformed uterine adhesion in balloon group will less than the percentage of the patients with reformed uterine adhesion in control group. A Chi-squared analysis was used.|
1591381|NCT03131479|2926170|Equivalence|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function*day and diabetic status*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-35.6||||0|2-Sided|90.0|-46.0|-25.11|||Regression, Logistic||||
1591382|NCT03131479|2926170|Equivalence|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function*day and diabetic status*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-21.5||||0.001|2-Sided|90.0|-31.79|4.55|||Regression, Logistic||||
1591383|NCT03131479|2926170|Equivalence|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function*day and diabetic status*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-6.05||||0.343|2-Sided|90.0|-16.65|4.55|||Regression, Logistic||||
1591384|NCT03131479|2926170|Equivalence|Change from baseline was analyzed using a repeated measures model which included diabetic status, renal function, day and renal function*day and diabetic status*day as fixed factors and age, baseline body weight and baseline fasting plasma glucose as covariates.|adjusted arithmetic mean difference|-9.21||||0.154|2-Sided|90.0|-19.88|1.45|||Regression, Logistic|An unstructured variance-covariance structure was used. Baseline is defined to be the measurement collected on Day -1.|||
1591385|NCT03129321|2926182|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1591386|NCT03129321|2926182|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1591387|NCT03129321|2926183|Superiority|||||||0.0076|||||||Cochran-Mantel-Haenszel||||
1591388|NCT03129321|2926183|Superiority|||||||0.002|||||||Cochran-Mantel-Haenszel||||
1591389|NCT03129321|2926184|Equivalence|Equivalence margin: +/-20%|Difference in proportions|-0.02|||||2-Sided|90.0|-8.29|8.26|||||||
1591390|NCT03129321|2926185|Equivalence|Equivalence margin: +/-20%|Difference in proportions|2.85|||||2-Sided|90.0|-6.29|11.98|||||||
1591391|NCT03129321|2926186|Superiority|||||||0.0004|||||||Cochran-Mantel-Haenszel||||
1591392|NCT03129321|2926186|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1591393|NCT03129321|2926187|Equivalence|Equivalence margin: +/-20%|Difference in proportions|4.24|||||2-Sided|90.0|-5.05|13.54|||||||
1591394|NCT03128307|2926209|Superiority||||||<|0.0001||||||a priori threshold for statistical significance of p = 0.05|t-test, 2 sided||||
1591395|NCT03128307|2926210|Superiority||||||<|0.0001||||||Assuming a priori threshold for statistical significant of p = 0.05|t-test, 2 sided||||
1591396|NCT03127644|2926228|Superiority|||||||0.0064||||||Nominal p value|Log Rank||||
1591397|NCT03127644|2926228|Superiority|||||||0.025||||||Nominal p value|Log Rank||||
1591400|NCT03127644|2926233|Superiority||Odds Ratio (OR)|15.334|||<|0.0001|2-Sided|95.0|4.006|58.697|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.|
1591401|NCT03127644|2926233|Superiority||Odds Ratio (OR)|1.347|||<|0.6167|2-Sided|95.0|0.419|4.329|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.|
1591402|NCT03127644|2926234|Other||Treatment difference in slopes|-0.00401|Standard Error of the Mean|0.000637|<|0.0001|2-Sided|95.0|-0.00527|-0.00275|||Mixed Models Analysis||Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).|
1591403|NCT03127644|2926234|Superiority||Treatment difference in slopes|-0.00231|Standard Error of the Mean|0.000645|<|0.0004|2-Sided|95.0|-0.00359|-0.00104|||Mixed Models Analysis||Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 24 hours was analysed with a mixed effect model (random slope model).|
1591404|NCT03127644|2926235|Superiority||Odds Ratio (OR)|71.835|||<|0.0001|2-Sided|95.0|13.497|382.337|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.|
1591405|NCT03127644|2926235|Superiority||Odds Ratio (OR)|46.495|||<|0.0001|2-Sided|95.0|10.142|213.152|||Regression, Logistic|||Logistic regression model including treatment and baseline S-K as explanatory variables was used.|
1591406|NCT03127644|2926236|Superiority||Treatment difference in slopes|-0.00261|Standard Error of the Mean|0.000385|<|0.001|2-Sided|95.0|-0.00337|-0.00185|||Mixed Models Analysis|Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).|Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).|
1591407|NCT03127644|2926236|Superiority||Treatment difference in slopes|-0.00496|Standard Error of the Mean|0.00038|<|0.0001|2-Sided|95.0|-0.00571|-0.0042|||Mixed Models Analysis|Confirmatory testing proceeded sequentially (ZS 10g TID, then ZS 5g TID).|Negative exponential rate of change relative to placebo indicates more rapid reduction (correction) of S-K.|Exponential rate of change in S-K through to 48 hours was analysed with a mixed effect model (random slope model).|
1591408|NCT03126682|2926243|Superiority|||||||0.212||||||Threshold of <0.05|t-test, 2 sided||||
1591409|NCT03125941|2926251|Superiority||Odds Ratio (OR)|3.53||||0.03|2-Sided|95.0|1.07|11.6|||Chi-squared||||
1591410|NCT03125941|2926252|Superiority||||||>|0.003||||||A priori threshold for statistical significans was 0.00125 due to multiple comparisons|Chi-squared||||
1591411|NCT03125941|2926253|Superiority||||||>|0.136|||||||Chi-squared||||
1591412|NCT03125941|2926254|Superiority||||||>|0.2|||||||Wilcoxon (Mann-Whitney)||||
1591413|NCT03125941|2926255|Superiority||||||>|0.193||||||a priori threshold, bonferroni corrected 0.0125|Wilcoxon (Mann-Whitney)||||
1591414|NCT03125941|2926257|Superiority|||||||0.217|||||||Wilcoxon (Mann-Whitney)||||
1591415|NCT03125941|2926258|Superiority|||||||0.35|||||||Wilcoxon (Mann-Whitney)||||
1591416|NCT03125941|2926261|Superiority|||||||0.294|||||||Wilcoxon (Mann-Whitney)||||
1591417|NCT03125941|2926262|Superiority|||||||0.114|||||||Wilcoxon (Mann-Whitney)||||
1591418|NCT03125941|2926263|Superiority||Odds Ratio (OR)|1.0||||1|2-Sided|95.0|0.49|2.05|||Chi-squared||||
1591419|NCT03125915|2926265|Superiority||Beta|-0.02||||0.96|2-Sided|95.0|-0.6|0.64||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of CT video among those who did not complete SUM.||
1591420|NCT03125915|2926265|Superiority||Beta|-0.53||||0.1|2-Sided|95.0|-1.16|0.11||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of CT video among those who completed SUM.||
1591421|NCT03125915|2926265|Superiority||Beta|-0.25||||0.49|2-Sided|95.0|-0.96|0.46||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effect of SUM among those who did not view the CT video.||
1591422|NCT03125915|2926265|Superiority||Beta|-0.79||||0.003|2-Sided|95.0|-1.32|-0.27||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of SUM among those who viewed CT videos.||
1591423|NCT03125915|2926265|Superiority||Beta|-0.19||||0.51|2-Sided|95.0|-0.76|0.38||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT video among those who did not complete SUM.||
1591424|NCT03125915|2926265|Superiority||Beta|-0.34||||0.23|2-Sided|95.0|-0.89|0.21||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effects of CT video among those who completed SUM.||
1591425|NCT03125915|2926265|Superiority||Beta|-0.49||||0.12|2-Sided|95.0|-1.11|0.12||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effects of SUM among those who did not complete CT video.||
1591426|NCT03125915|2926265|Superiority||Beta|-0.64||||0.01|2-Sided|95.0|-1.13|-0.15||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of SUM among those who completed the CT video.||
1591427|NCT03125915|2926265|Superiority||Beta|-0.41||||0.19|2-Sided|95.0|-1.01|0.2||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effects of CT video among those who did not complete SUM.||
1591428|NCT03125915|2926265|Superiority||Beta|-0.15||||0.63|2-Sided|95.0|-0.77|0.47||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effects of CT video among those who completed SUM.||
1591429|NCT03125915|2926265|Superiority||Beta|-0.49||||0.1|2-Sided|95.0|-1.07|0.09||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who did not view CT videos.||
1591430|NCT03125915|2926265|Superiority||Beta|-0.75||||0.02|2-Sided|95.0|-1.39|-0.11||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who viewed CT videos.||
1591431|NCT03125915|2926266|Superiority||Beta|-1.28||||0.45|2-Sided|95.0|-4.62|2.06||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of the interaction between SUM and CT videos in the prediction of the latent slope factor.||
1591432|NCT03125915|2926266|Superiority||Beta|0.35||||0.76|2-Sided|95.0|-2.02|2.72||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of CT Video on latent slope factor among those who did not complete the SUM.||
1591433|NCT03125915|2926266|Superiority||Beta|1.83||||0.14|2-Sided|95.0|-0.62|4.29||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effect of SUM on the latent slope factor among those who did not view CT Videos.||
1591434|NCT03125915|2926266|Superiority||Beta|-1.18||||0.53|2-Sided|95.0|-4.86|2.51||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of the interaction between SUM and CT video on the latent intercept.||
1591435|NCT03125915|2926266|Superiority||Beta|0.26||||0.78|2-Sided|95.0|-2.23|2.75||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effects of CT video on the latent intercept factor among those who did not view SUM.||
1591436|NCT03125915|2926266|Superiority||Beta|0.05||||0.9|2-Sided|95.0|-2.3|2.41||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||Effect of SUM on the latent intercept factor among those who did not view CT videos||
1591437|NCT03125915|2926267|Superiority||Beta|3.13||||0.05|2-Sided|95.0|-0.004|6.25||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of CT video among those who did not complete SUM.||
1591438|NCT03125915|2926267|Superiority||Beta|-0.24||||0.83|2-Sided|95.0|-2.39|1.91||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow up, effect of CT video among those who completed the SUM.||
1591439|NCT03125915|2926267|Superiority||Beta|-0.57||||0.67|2-Sided|95.0|-3.16|2.03||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow up, effect of SUM among those who did not view CT video.||
1591440|NCT03125915|2926267|Superiority||Beta|-3.93||||0.014|2-Sided|95.0|-7.06|-0.81||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||6-month follow-up, effects of SUM among those who viewed the CT video.||
1591441|NCT03125915|2926267|Superiority||Beta|-0.3||||0.75|2-Sided|95.0|-2.12|1.53||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT video among those who did not complete SUM.||
1591442|NCT03125915|2926267|Superiority||Beta|0.4||||0.78|2-Sided|95.0|-2.35|3.16||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-month follow-up, effect of CT Video among those who completed the SUM|A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|
1591463|NCT03123471|2926428|Superiority||Difference in LS Mean|-2.9|||<|0.0001|2-Sided|95.0|-4.17|-1.73|||ANCOVA|Treatment and stratification factor (Baseline ScPGA moderate or severe) as independent variables and baseline value as a covariate variable.|||
1591443|NCT03125915|2926267|Superiority||Beta|-2.09||||0.1|2-Sided|95.0|-4.56|0.38||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-Month follow up, effect of SUM among those who did not view CT video||
1591444|NCT03125915|2926267|Superiority||Beta|-2.79||||0.013|2-Sided|95.0|-5.0|-0.58||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||3-Month follow up, effect of SUM among those who viewed the CT video.||
1591445|NCT03125915|2926267|Superiority||Beta|-2.3||||0.14|2-Sided|95.0|-5.37|0.77||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-Month follow up, effect of CT video among those who did not complete SUM.||
1591446|NCT03125915|2926267|Superiority||Beta|-0.35||||0.75|2-Sided|95.0|-2.5|1.8||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow up, effect of CT video among those who completed the SUM.||
1591447|NCT03125915|2926267|Superiority||Beta|-1.67||||0.18|2-Sided|95.0|-4.1|0.76||A multi-level latent growth curve (LGC) with an intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-level latent growth curve||1-month follow-up, effect of SUM among those who did not view the CT video.||
1591448|NCT03125915|2926267|Superiority||Beta|-3.62||||0.03|2-Sided|95.0|-6.78|-0.46||A multi-level latent growth curve (LGC) with a intercept and linear slope was specified. The main effects of SUM and CT video were modeled at level 2 in addition to their interaction. Drug use was specified as a binomial distribution.|multi-leve latent growth curve||For 1-Month Follow-Up, substance use module (SUM) among those who did not view CT Video||
1591449|NCT03124784|2926305|Equivalence|ARMS<= 3 %SpO2 Error per International Organization For Standardization (ISO) -80601-2-61 Pilot study Monte Carlo simulation provided 80% Power with 25 subjects for an expected ARMS< 3 % SpO2.|ARMS|0.0|||||2-Sided|||||||||Accuracy Root Mean Square (ARMS)|Per ISO-80601-2-61, the Root Mean Square difference (SpO2-SaO2) is the measure of merit for desaturation studies.
1591450|NCT03124563|2926310|Superiority|||||||0.022|||||||Mixed Models Analysis|Controlling for age, gender, and level of education|||
1591451|NCT03124563|2926311|Superiority|||||||0.349|||||||ANOVA||||
1591452|NCT03124563|2926312|Superiority|||||||0.308|||||||Mixed Models Analysis|Controlling for age, gender, and level of education|||
1591453|NCT03124563|2926313|Superiority|||||||0.065|||||||Mixed Models Analysis|Controlling for age, gender, and education|||
1591454|NCT03124563|2926314|Superiority|||||||0.034|||||||Mixed Models Analysis|Controlling for age, gender, and functional health|||
1591455|NCT03124563|2926315|Superiority||||||=|0|||||||Mixed Models Analysis|Controlling for age, gender, and functional health|||
1591456|NCT03124381|2926361|Superiority|Superiority concluded if the upper bound of the two-sided 95% confidence interval of the treatment difference is less than 0. Terms for treatment, gender, and center as factors and baseline score as covariate.|Mean Difference (Net)|3.19|Standard Error of the Mean|5.164||0.538|2-Sided|95.0|-7.04|13.42|||ANCOVA|||Superiority test performed after non-inferiority confirmed as described above. The null hypothesis for the superiority test was H0: A−B = 0, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Acne Mask and the Gel-Cream + Acne Mask cell, respectively.|
1591457|NCT03124381|2926361|Non-Inferiority|Non-inferiority concluded if the upper bound of the two-sided 95% confidence interval (based on ANCOVA) is less than 15 percentage points. Terms for treatment, gender, center as factors and baseline as covariate.|Mean Difference (Net)|3.19|Standard Error of the Mean|5.164|||2-Sided|95.0|-7.04|13.42||||||Non-inferiority test performed after significance vs. baseline confirmed for each cell. The null hypothesis for the non-inferiority test was H0: A-B≥15%, where A and B are the mean percent change at Week 12 of global face total acne lesion count of the Gel-Cream + Acne Mask cell and Acne Mask cell, respectively.|
1591458|NCT03124108|2926411|Superiority||Difference in percentage|-43.9|Standard Error of the Mean|6.0|<|0.001|2-Sided|95.0|-55.7|-32.1|||ANCOVA||||
1591459|NCT03124108|2926411|Superiority||Difference in percentage|-52.0|Standard Error of the Mean|5.4|<|0.001|2-Sided|95.0|-62.5|-41.5|||ANCOVA||||
1591460|NCT03123874|2926412|Other|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first). Random effect was participant ID to account for multiple samples for each participant.|Mean Difference (Final Values)|4.95||||0.0003|2-Sided|||||Results were considered statistically significant at p<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean bacterial counts in milk collected with own / sterile pump set-ups.||
1591461|NCT03123874|2926413|Other|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first).|Mean Difference (Final Values)|0.163||||0.3|2-Sided|||||Results were considered statistically significant at p<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean Shannon Diversity Index in milk collected with own / sterile pump set-ups||
1591462|NCT03123874|2926414|Other|Linear mixed effects models testing the effect of pump set-up on the number of live aerobic bacterial counts. The fixed effect of interest will be pump set-up. Model will also be adjusted for infant feeding status (human milk only vs. human milk and complementary foods) and randomization schedule (which pump set-up went first).|Mean Difference (Final Values)|0.827||||0.9|2-Sided|||||Results were considered statistically significant at p<0.05. No adjustments were made to p-values.|Mixed Models Analysis||Ratio of mean bacterial taxa in milk collected with own / sterile pump set-ups.||
1591832|NCT03101462|2926971|Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 7|
1591464|NCT03123471|2926429|Superiority||Difference in Response|27.0|||<|0.0001|2-Sided|95.0|15.1|38.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 12; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and SE using a normal approximation to the weighted average were calculated.|
1591465|NCT03123471|2926429|Superiority||Difference in Response|22.0|||<|0.0003|2-Sided|95.0|10.2|33.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 8; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.|
1591466|NCT03123471|2926429|Superiority||Difference in Response|21.3|||<|0.0001|2-Sided|95.0|10.6|31.9|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 4; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.|
1591467|NCT03123471|2926429|Superiority||Difference in Response|14.6|||<|0.0025|2-Sided|95.0|5.1|24.1|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 2; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.|
1591468|NCT03123471|2926430|Superiority||Difference in Response|20.6||||0.0007|2-Sided|95.0|8.7|32.4|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 12; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and SE using a normal approximation to the weighted average were calculated.|
1591469|NCT03123471|2926430|Superiority||Difference in Response|20.1||||0.0003|2-Sided|95.0|9.1|31.0|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 8; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.|
1591470|NCT03123471|2926430|Superiority||Difference in Response|22.1|||<|0.0001|2-Sided|95.0|12.9|31.4|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 4. The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.|
1591471|NCT03123471|2926430|Superiority||Difference in Response|17.0|||<|0.0001|2-Sided|95.0|9.8|24.2|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||Week 2; The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.|
1591472|NCT03123471|2926431|Superiority||Difference in Response|26.2|||<|0.0001|2-Sided|95.0|13.9|38.5|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.|
1591473|NCT03123471|2926432|Superiority||Difference in Response|23.0|||<|0.0001|2-Sided|95.0|11.5|34.6|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.|
1591474|NCT03123471|2926433|Superiority||Difference in Response|29.6|||<|0.0001|2-Sided|95.0|19.5|39.7|||Cochran-Mantel-Haenszel|Analysis used CMH; adjusted by stratification factor of baseline ScPGA score moderate (3) or severe (4).||The adjusted difference in response rates using the weighted average of the treatment differences across the strata with the CMH weights and the 2-sided 95% confidence interval using a normal approximation to the weighted average were calculated.|
1591475|NCT03123263|2926436|Other|Repeated measures one sided ANOVA was used to analyze changes in ejection fraction over time.|||||<|0.0005|||||||ANOVA|F (2,98) =13.974|||
1591476|NCT03122886|2926448|Superiority||Hazard Ratio (HR)|0.88||||0.9|2-Sided|95.0|0.12|6.37|||Log Rank||||
1591477|NCT03122145|2926475|Superiority|Mann whitney U between groups comparison for voluntary cough parameters between healthy controls and individuals with ALS outcomes: peak expiratory cough flow and cough volume acceleration||||||0.0005|||||||ANOVA|||Hypothesis that voluntary cough > reflex cough strength and effectiveness in healthy volunteers|
1591478|NCT03121820|2926481|Non-Inferiority or Equivalence|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %|Test/Ref Geometric mean ratio x 100|92.3||||0.05|2-Sided|90.0|86.37|98.55|||Test/Ref Geometric mean ratio x 100|Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.||Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg|
1591479|NCT03121820|2926482|Non-Inferiority or Equivalence|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric mean ratios were fully contained within the predefined equivalence limits of 80.00 % to 125.00 %|Test/Ref Geometric mean ratio x 100|93.8||||0.05|2-Sided|90.0|88.25|99.77|||Test/Ref Geometric mean ratio x 100|Bioequivalence is established when 90% Confidence Interval falls within 80.00 % -125.00 %.||Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg|
1591480|NCT03121612|2926483|Superiority|||||||1|||||||Fisher Exact|No adjustment for multiple comparisons|||
1591481|NCT03121612|2926485|Superiority|||||||1||||||No adjustment for multiple comparisons.|Fisher Exact|No failures in older stratum, so stratification by gestational age-group not controlled for in analysis.|||
1591482|NCT03121612|2926491|Superiority|||||||1|||||||Fisher Exact||||
1591483|NCT03121612|2926492|Superiority|||||||0.81||||||Not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation|||
1591484|NCT03121612|2926493|Superiority|||||||0.31||||||Not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|Controlling for stratification by gestational age-group.|||
1591485|NCT03121612|2926494|Superiority|||||||0.33||||||Not adjusted for multiple comparisons|Cochran-Mantel-Haenszel|Controlling for stratification by gestational group.|||
1591486|NCT03121612|2926495|Superiority|||||||1||||||Not adjusted for multiple comparisons.|Fisher Exact|No failures in older stratum, so stratification by gestational age-group not controlled for in analysis.|||
1591487|NCT03121612|2926499|Superiority|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.86||||||Threshold for superiority p<0.05; not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation.||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution non-normal, so non-parametric test (Wilcoxon) used."|
1591488|NCT03121612|2926500|Superiority|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.8||||||Threshold for superiority p<0.05; not adjusted for multiple comparisons|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation.||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution not normal by visual examination, so non-parametric test (Wilcoxon) used."|
1591489|NCT03121612|2926501|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)|||Planned sub-group analysis for infants born at 34-36 gestational weeks (n=10). No adjustment for multiple comparisons.|
1591490|NCT03121612|2926501|Superiority|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Planned sub-group analysis for infants born at 28-33 gestational weeks (n=41). No adjustment for multiple comparisons.|
1591491|NCT03121612|2926501|Superiority|Power calculated based on 40 infants in each arm, permitting detection of a difference of 0.67 SD between the groups with power of 80% and alpha=0.05. Study recruitment was below anticipated (51/80) despite extending the planned period of recruitment.||||||0.65||||||Threshold for superiority p<0.05; primary outcome, so not adjusted for multiple comparisons.|van Elteren's extension to Wilcoxon|van Elteren's extension used to control for stratification by gestation||"Analysis restricted to change at 6 hours, as least affected by missing data.~Distribution non-normal, so non-parametric test (Wilcoxon) used."|
1591492|NCT03121365|2926502|Equivalence|0.05||||||0.4251|||||||t-test, 2 sided|||StimQ scores between infants 6 months of age and 12 months of age in the board book arm and e-book arm|
1591493|NCT03121365|2926502|Equivalence|0.05||||||0.4144|||||||t-test, 2 sided|||StimQ scores between infants 9 months of age and 12 months of age in the board book arm and e-book arm|
1591494|NCT03121365|2926502|Equivalence|0.05||||||0.018|||||||t-test, 2 sided|||StimQ scores between infants 6 months of age and 9 months of age in the board book arm and e-book arm|
1591495|NCT03121365|2926503|Equivalence|0.05||||||0.2291|||||||t-test, 2 sided|||Gross Motor Composite Scores between infants 12-18 months old in the Standard and Digital Arms|
1591496|NCT03121365|2926503|Equivalence|0.05||||||0.0996|||||||t-test, 2 sided|||Language Composite Scores between infants 12-18 months old in the Standard and Digital Arms|
1591497|NCT03121365|2926503|Equivalence|0.05||||||0.7635|||||||t-test, 2 sided|||Bayley Scales of Infant and Toddler Development Cognitive Composite Scores between infants 12-18 months old in the Standard and Digital Arms|
1591498|NCT03120351|2926509|Superiority||Mean Difference (Net)|-2.5||||0.28|2-Sided|95.0|-7.11|2.06|||Mixed Models Analysis||||
1591499|NCT03120013|2926510|Superiority||||||=|0|||||||ANCOVA||||
1591500|NCT03120013|2926511|Superiority||||||<|0.001|||||||ANCOVA||||
1591501|NCT03120013|2926512|Superiority||||||=|0|||||||ANCOVA||||
1591502|NCT03120013|2926513|Superiority||||||<|0.001|||||||ANCOVA||||
1591503|NCT03120013|2926514|Superiority||||||<|0.001|||||||ANCOVA||||
1591504|NCT03120013|2926515|Superiority||||||<|0.001|||||||ANCOVA||||
1591505|NCT03120013|2926516|Superiority||||||<|0.001|||||||ANCOVA||||
1591506|NCT03120013|2926517|Superiority||||||<|0.001|||||||ANCOVA||||
1591507|NCT03119688|2926527|Superiority|This is a superiority test setting.|Mean Difference (Net)|0.065||||0.2518|2-Sided|90.0|-0.0287|0.1592||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.|
1591508|NCT03119688|2926527|Superiority|This is a superiority test setting.|Mean Difference (Net)|0.427|||<|0.0001|2-Sided|90.0|0.3333|0.5211||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.|
1591509|NCT03119688|2926527|Superiority|This is a superiority test setting.|Mean Difference (Net)|0.35|||<|0.0001|2-Sided|90.0|0.2565|0.4441||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects;participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis is that the difference in population mean dryness is zero.|
1591833|NCT03101462|2926971|Other|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 45|
1591510|NCT03119688|2926527|Non-Inferiority|The non-Inferiority margin is set at 0.25. The upper limit of the 90% CI is less than this and hence NI is met.|Mean Difference (Net)|-0.077|||<|0.1769|2-Sided|90.0|-0.1707|0.0169||No adjustment for multiple comparisons was made.|ANOVA|ANOVA model with change from baseline in examiner assessment on dryness as response and treatment, site as fixed effects; participant as random effect|Difference is first named treatment minus second named treatment such that a negative difference favors first named treatment.|The null hypothesis (non-inferiority setting) is that the population mean dryness for Test minus Baxter Sterile Water (negative control) is at least 0.25.|
1591511|NCT03119649|2926538|Superiority||Difference in LS Means|1.6|Standard Error of the Mean|4.43||0.7212|2-Sided|95.0|-7.3|10.5||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo|
1591512|NCT03119649|2926538|Superiority||Difference in LS Means|6.8|Standard Error of the Mean|4.43||0.1282|2-Sided|95.0|-2.0|15.7||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo|
1591513|NCT03119649|2926538|Superiority||Difference in LS Means|1.6|Standard Error of the Mean|4.83||0.7381|2-Sided|95.0|-8.1|11.3||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo|
1591514|NCT03119649|2926538|Superiority||Difference in LS Means|2.7|Standard Error of the Mean|4.81||0.5749|2-Sided|95.0|-6.9|12.4||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo|
1591515|NCT03119649|2926539|Superiority||Difference in LS Means|2.3|Standard Error of the Mean|1.94||0.2403|2-Sided|95.0|-1.6|6.2||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo|
1591516|NCT03119649|2926539|Superiority||Difference in LS Means|1.0|Standard Error of the Mean|1.94||0.5958|2-Sided|95.0|-2.9|4.9||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo|
1591517|NCT03119649|2926539|Superiority||Difference in LS Means|0.6|Standard Error of the Mean|2.06||0.7553|2-Sided|95.0|-3.5|4.8||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo|
1591518|NCT03119649|2926539|Superiority||Difference in LS Means|1.1|Standard Error of the Mean|2.11||0.594|2-Sided|95.0|-3.1|5.4||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo|
1591519|NCT03119649|2926540|Superiority||Difference in LS Means|-6.3|Standard Error of the Mean|3.76||0.0995|2-Sided|95.0|-13.9|1.2||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 400 mg QD vs. Pooled Placebo|
1591520|NCT03119649|2926540|Superiority||Difference in LS Means|-15.8|Standard Error of the Mean|3.72|<|0.0001|2-Sided|95.0|-23.2|-8.3||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 200 mg QD vs. Pooled Placebo|
1591521|NCT03119649|2926540|Superiority||Difference in LS Means|-4.1|Standard Error of the Mean|4.32|<|0.3477|2-Sided|95.0|-12.8|4.6||P-value obtained from the MMRM analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 100 mg QD vs. Pooled Placebo|
1591522|NCT03119649|2926540|Superiority||Difference in LS Means|-3.3|Standard Error of the Mean|4.15|<|0.4291|2-Sided|95.0|-11.6|5.0||P-value obtained from the Mixed Effects Model for Repeated Measures (MMRM) analysis with treatment as factor and baseline as covariate. Pairwise comparisons were not corrected for multiplicity.|ANCOVA|||Day 29: GLPG2222 50 mg QD vs. Pooled Placebo|
1591523|NCT03119181|2926547|Superiority|||||||0.0097|||||||one-sided permutation test|||one-sided permutation test at 2.5% significance|
1591524|NCT03118934|2926557|Non-Inferiority|The pre-specified non-inferiority margin is 0.5. With a sample size of 80/group, there was approximately 83% power to reject the null hypothesis of inferiority in fit with assumed standard deviation of 0.6 and expected difference of 0.25 (one-sided alpha=0.05).|LSM Difference|-0.2|Standard Error of the Mean|0.06|||1-Sided|95.0||-0.1|||||||
1591525|NCT03118765|2926564|Superiority||Mean Difference (Final Values)|0.15||||0.002|2-Sided|95.0|0.06|0.24|||Mixed Models Analysis||||
1591526|NCT03118765|2926564|Superiority||Mean Difference (Final Values)|0.07||||0.14|2-Sided|95.0|-0.02|0.16|||Mixed Models Analysis||||
1591527|NCT03118765|2926564|Superiority||Mean Difference (Final Values)|0.09||||0.061|2-Sided|95.0|0.0|0.18|||Mixed Models Analysis||||
1591528|NCT03118765|2926564|Superiority||Mean Difference (Final Values)|0.15||||0.002|2-Sided|95.0|0.06|0.24|||Mixed Models Analysis||||
1591529|NCT03118765|2926565|Superiority||Mean Difference (Final Values)|0.16|||<|0.001|2-Sided|95.0|0.08|0.23|||Mixed Models Analysis||||
1591530|NCT03118765|2926565|Superiority||Mean Difference (Final Values)|0.13|||<|0.001|2-Sided|95.0|0.06|0.21|||Mixed Models Analysis||||
1591531|NCT03118765|2926565|Superiority||Mean Difference (Final Values)|0.14|||<|0.001|2-Sided|95.0|0.06|0.22|||Mixed Models Analysis||||
1591532|NCT03118765|2926565|Superiority||Mean Difference (Final Values)|0.12|||<|0.003|2-Sided|95.0|0.04|0.2|||Mixed Models Analysis||||
1591533|NCT03118765|2926566|Superiority||Mean Difference (Final Values)|0.05||||0.5|2-Sided|95.0|-0.1|0.2|||Mixed Models Analysis||||
1591534|NCT03118765|2926566|Superiority||Mean Difference (Final Values)|0.0||||0.978|2-Sided|95.0|-0.16|0.15|||Mixed Models Analysis||||
1591535|NCT03118765|2926566|Superiority||Mean Difference (Final Values)|-0.01||||0.864|2-Sided|95.0|-0.17|0.14|||Mixed Models Analysis||||
1591536|NCT03118765|2926566|Superiority||Mean Difference (Final Values)|0.05||||0.493|2-Sided|95.0|-0.1|0.21|||Mixed Models Analysis||||
1599059|NCT02858401|2938157|Other|||||||1|||||||Fisher Exact||||
1591537|NCT03118765|2926567|Superiority||Mean Difference (Final Values)|0.03||||0.574|2-Sided|95.0|-0.09|0.16|||Mixed Models Analysis||||
1591538|NCT03118765|2926567|Superiority||Mean Difference (Final Values)|0.05||||0.401|2-Sided|95.0|-0.07|0.17|||Mixed Models Analysis||||
1591539|NCT03118765|2926567|Superiority||Mean Difference (Final Values)|0.08||||0.182|2-Sided|95.0|-0.04|0.21|||Mixed Models Analysis||||
1591540|NCT03118765|2926567|Superiority||Mean Difference (Final Values)|0.09||||0.166|2-Sided|95.0|-0.04|0.21|||Mixed Models Analysis||||
1591541|NCT03118765|2926568|Superiority||Mean Difference (Final Values)|0.17||||0.001|2-Sided|95.0|0.07|0.27|||Mixed Models Analysis||||
1591542|NCT03118765|2926568|Superiority||Mean Difference (Final Values)|0.11||||0.032|2-Sided|95.0|0.01|0.21|||Mixed Models Analysis||||
1591543|NCT03118765|2926568|Superiority||Mean Difference (Final Values)|0.15||||0.005|2-Sided|95.0|0.05|0.25|||Mixed Models Analysis||||
1591544|NCT03118765|2926568|Superiority||Mean Difference (Final Values)|0.18||||0.001|2-Sided|95.0|0.08|0.28|||Mixed Models Analysis||||
1591545|NCT03118765|2926569|Superiority||Mean Difference (Final Values)|0.17|||<|0.001|2-Sided|95.0|0.08|0.26|||Mixed Models Analysis||||
1591546|NCT03118765|2926569|Superiority||Mean Difference (Final Values)|0.12|||<|0.007|2-Sided|95.0|0.03|0.21|||Mixed Models Analysis||||
1591547|NCT03118765|2926569|Superiority||Mean Difference (Final Values)|0.17|||<|0.001|2-Sided|95.0|0.08|0.26|||Mixed Models Analysis||||
1591548|NCT03118765|2926569|Superiority||Mean Difference (Final Values)|0.13|||<|0.004|2-Sided|95.0|0.04|0.21|||Mixed Models Analysis||||
1591549|NCT03118765|2926570|Other||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 2.125 for GSP304 40 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.
1591550|NCT03118765|2926570|Other||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 1.808 for GSP304 20 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.
1591551|NCT03118765|2926570|Other||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on Cmax of 1.944 for GSP304 10 μg and 1.929 for SPIRIVA RESPIMAT 5 μg.
1591552|NCT03118765|2926571|Other||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.926 for GSP304 40 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.
1591553|NCT03118765|2926571|Other||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.522 for GSP304 20 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.
1591554|NCT03118765|2926571|Other||||||||||||||||||Upon repeat dosing, tiotropium had accumulated by Day 21 with a geometric mean accumulation ratio (Rac) based on AUC of 2.617 for GSP304 10 μg and 2.815 for SPIRIVA RESPIMAT 5 μg.
1591555|NCT03118765|2926572|Other||||||||||||||||||For GSP304 40 μg, the geometric mean CavSS was 5.083 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21
1591556|NCT03118765|2926572|Other||||||||||||||||||For GSP304 20 μg, the geometric mean CavSS was 1.998 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21
1591557|NCT03118765|2926572|Other||||||||||||||||||For GSP304 10 μg, the geometric mean CavSS was 0.9536 pg/mL on Day 21 and for SPIRIVA RESPIMAT 5 μg, the CavSS was 2.403 pg/mL on Day 21
1591558|NCT03118765|2926575|Other||||||||||||||||||For GSP304 40 μg, geometric mean AUC0-tau of tiotropium was 42.69 pg*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg*h/mL on Day 1.
1591559|NCT03118765|2926575|Other||||||||||||||||||For GSP304 20 μg, geometric mean AUC0-tau of tiotropium was 18.00 pg*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg*h/mL on Day 1.
1591560|NCT03118765|2926575|Other||||||||||||||||||For GSP304 10 μg, geometric mean AUC0-tau of tiotropium was 8.597 pg*h/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean AUC0-tau of tiotropium was 19.59 pg*h/mL on Day 1.
1591561|NCT03118765|2926576|Other||||||||||||||||||For GSP304 40 μg, geometric mean Cmax of tiotropium was 10.2 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.
1591562|NCT03118765|2926576|Other||||||||||||||||||For GSP304 20 μg, geometric mean Cmax of tiotropium was 4.796 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.
1591563|NCT03118765|2926576|Other||||||||||||||||||For GSP304 10 μg, geometric mean Cmax of tiotropium was 2.191 pg/mL and for SPIRIVA RESPIMAT 5 μg, geometric mean Cmax of tiotropium was 7.327 pg/mL on Day 1.
1591564|NCT03118765|2926577|Other||||||||||||||||||For GSP304 40 μg, the geometric mean Fe (%) eliminated in urine was 3.123% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21
1591565|NCT03118765|2926577|Other||||||||||||||||||For GSP304 20 μg, the geometric mean Fe (%) eliminated in urine was 2.183% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21
1591566|NCT03118765|2926577|Other||||||||||||||||||For GSP304 10 μg, the geometric mean Fe (%) eliminated in urine was 2.937% on Day 21 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 12.4% on Day 21
1591567|NCT03118765|2926578|Other||||||||||||||||||For GSP304 40 μg, the geometric mean Fe (%) eliminated in urine was 1.096% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1
1591568|NCT03118765|2926578|Other||||||||||||||||||For GSP304 20 μg, the geometric mean Fe (%) eliminated in urine was 1.316% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1
1591569|NCT03118765|2926578|Other||||||||||||||||||For GSP304 10 μg, the geometric mean Fe (%) eliminated in urine was 1.082% on Day 1 and for SPIRIVA RESPIMAT 5 μg, the geometric mean Fe (%) eliminated in urine was 2.407% on Day 1
1591570|NCT03118765|2926579|Other||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 40 μg was (Geo mean: 1249000 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).
1591571|NCT03118765|2926579|Other||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 20 μg was (Geo mean: 436500 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).
1591572|NCT03118765|2926579|Other||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 21 for GSP304 10 μg was (Geo mean: 293700 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 620200 pg).
1591573|NCT03118765|2926580|Other||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 40 μg was (Geo mean: 438300 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).
1591574|NCT03118765|2926580|Other||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 20 μg was (Geo mean: 263100 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).
1591575|NCT03118765|2926580|Other||||||||||||||||||The mean amount of tiotropium excreted in urine over the dosing interval on Day 1 for GSP304 10 μg was (Geo mean: 108200 pg) and for SPIRIVA RESPIMAT 5 μg was (Geo mean: 120300 pg).
1591576|NCT03118765|2926581|Superiority||Mean Difference (Final Values)|0.06||||0.26|2-Sided|95.0|-0.04|0.16|||MMRM|||SPIRIVA RESPIMAT 5 μg vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.|
1591577|NCT03118765|2926581|Superiority||Mean Difference (Final Values)|0.01||||0.894|2-Sided|95.0|-0.1|0.11|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.|
1591578|NCT03118765|2926581|Superiority||Mean Difference (Net)|0.02||||0.655|2-Sided|95.0|-0.08|0.13|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.|
1591579|NCT03118765|2926581|Superiority||Mean Difference (Final Values)|0.06||||0.228|2-Sided|95.0|-0.04|0.17|||MMRM|||GSP 304 vs Placebo comparison for change from baseline in trough FEV1 was tested at 0.05 significance level.|
1591580|NCT03118765|2926582|Other|ANOVA|LS mean ratio (%)|211.5|||||2-Sided|90.0|158.8|281.8|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.|
1591581|NCT03118765|2926582|Other|ANOVA|LS mean ratio (%)|85.2|||||2-Sided|90.0|64.43|112.64|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.|
1591582|NCT03118765|2926582|Other|ANOVA|LS mean ratio (%)|39.7|||||2-Sided|90.0|29.79|52.87|||||Relative Bioavailability (%) based on AUC0-tauSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on AUC0-tauSS was tested and the estimated treatment ratios for the treatment comparisons was presented.|
1591583|NCT03118765|2926583|Other|ANOVA|LS mean ratio (%)|155.8|||||2-Sided|90.0|111.88|216.99|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.|
1591584|NCT03118765|2926583|Other|ANOVA|LS mean ratio (%)|57.0|||||2-Sided|90.0|41.37|78.46|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.|
1591585|NCT03118765|2926583|Other|ANOVA|LS mean ratio (%)|29.4|||||2-Sided|90.0|21.14|41.0|||||Relative Bioavailability (%) based on CmaxSS for of GSP304 in comparison to SPIRIVA RESPIMAT|GSP 304 vs SPIRIVA RESPIMAT 5 μg comparison for relative bioavailability data based on CmaxSS was tested and the estimated treatment ratios for the treatment comparisons was presented.|
1591586|NCT03118739|2926626|Superiority||Mean % Change from Baseline|-39.37|||||2-Sided|90.0|-61.785|-3.814|||||||
1591587|NCT03118297|2926635|Other|No statistical test performed|||||||||||||||||Significance testing not performed. All values below prespecified limit of 5.0 ng/mL.
1591588|NCT03118297|2926636|Superiority||||||>|0.05||||||Threshold for significance: p=0.05|Chi-squared||||
1591589|NCT03118297|2926637|Superiority||||||<|0.001||||||Threshold for significance: p=0.05|Fisher Exact||||
1591590|NCT03118297|2926638|Superiority|||||||0.032||||||Threshold for significance: p=0.05|Fisher Exact||||
1591591|NCT03118297|2926639|Superiority|||||||0.002||||||Threshold for significance: p=0.05|Wilcoxon (Mann-Whitney)||||
1591592|NCT03117569|2926648|Non-Inferiority|A total of 375 participants (2:1 randomisation) were planned for enrolment and evaluation as ITT population. Under the assumption that SVR12 rate would be 96% in both arms, the study had 80% power to show non-inferiority of the simplified monitoring strategy with a lower confidence bound for SVR12 in the simplified monitoring arm greater than 90% or with a lower confidence bound for the difference (simplified arm minus standard arm) in SVR12 greater than -6%.|Difference in Percentage of Participants|-3.2|||<|0.05|2-Sided|95.0|-8.2|1.8|||t-test, 2 sided||||
1591593|NCT03115827|2926688|Other|||||||0.6|||||||t-test, 2 sided||||
1591594|NCT03115476|2926699|Other||Hazard Ratio (HR)|1.99|||<|0.01|2-Sided|95.0|1.17|3.62|||likelihood ratio test|||relative difference between treatment groups (ingenol disoxate gel vs vehicle) expressed as hazard ratio|
1591595|NCT03115476|2926700|Other||Hazard Ratio (HR)|1.43||||0.43|2-Sided|95.0|0.61|3.9|||likelihood ratio test|||Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio|
1591596|NCT03114969|2926705|Superiority||Odds Ratio (OR)|2.974||||0.003|2-Sided|95.0|1.461|6.055||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591597|NCT03114969|2926705|Superiority||Odds Ratio (OR)|2.889||||0.003|2-Sided|95.0|1.434|5.819||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591712|NCT03109184|2926778|Superiority||Effect Size (d)|0.13|||||2-Sided||||||||9-month follow-up between groups effect size of adolescent reported number of relationship topics discussed||
1599060|NCT02858401|2938158|Other|||||||0.3333|||||||Fisher Exact||||
1591598|NCT03114969|2926705|Superiority||Odds Ratio (OR)|2.389||||0.035|2-Sided|95.0|1.061|5.376||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591599|NCT03114969|2926705|Superiority||Odds Ratio (OR)|2.434||||0.024|2-Sided|95.0|1.123|5.276||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591600|NCT03114969|2926706|Superiority||Odds Ratio (OR)|2.757||||0.029|2-Sided|95.0|1.107|6.862||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591601|NCT03114969|2926706|Superiority||Odds Ratio (OR)|2.523||||0.052|2-Sided|95.0|0.993|6.407||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591602|NCT03114969|2926707|Superiority||Odds Ratio (OR)|1.402||||0.553|2-Sided|95.0|0.459|4.283||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591603|NCT03114969|2926707|Superiority||Odds Ratio (OR)|1.51||||0.472|2-Sided|95.0|0.492|4.633||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591604|NCT03114969|2926708|Superiority||Odds Ratio (OR)|2.415||||0.018|2-Sided|95.0|1.161|5.024||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591605|NCT03114969|2926708|Superiority||Odds Ratio (OR)|1.95||||0.082|2-Sided|95.0|0.918|4.142||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591606|NCT03114969|2926708|Superiority||Odds Ratio (OR)|2.079||||0.086|2-Sided|95.0|0.901|4.799||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591607|NCT03114969|2926708|Superiority||Odds Ratio (OR)|1.738||||0.189|2-Sided|95.0|0.761|3.968||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591608|NCT03114969|2926709|Superiority||Odds Ratio (OR)|1.591||||0.33|2-Sided|95.0|0.625|4.05||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591609|NCT03114969|2926709|Superiority||Odds Ratio (OR)|1.502||||0.404|2-Sided|95.0|0.578|3.905||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591610|NCT03114969|2926710|Superiority||Odds Ratio (OR)|1.208||||0.746|2-Sided|95.0|0.385|3.788||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591713|NCT03109184|2926778|Superiority||Effect Size (d)|0.62|||||2-Sided||||||||3-month follow-up between groups effect size of adolescent reported number of relationship topics discussed||
1599061|NCT02858401|2938159|Other|||||||1|||||||Fisher Exact||||
1591611|NCT03114969|2926710|Superiority||Odds Ratio (OR)|4.929||||0.007|2-Sided|95.0|1.556|15.612||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591612|NCT03114969|2926710|Superiority||Odds Ratio (OR)|5.93||||0.002|2-Sided|95.0|1.89|18.611||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591613|NCT03114969|2926710|Superiority||Odds Ratio (OR)|2.555||||0.083|2-Sided|95.0|0.886|7.369||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591614|NCT03114969|2926710|Superiority||Odds Ratio (OR)|3.804||||0.01|2-Sided|95.0|1.372|10.544||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591615|NCT03114969|2926710|Superiority||Odds Ratio (OR)|1.274||||0.679|2-Sided|95.0|0.405|4.005||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591616|NCT03114969|2926710|Superiority||Odds Ratio (OR)|4.655||||0.009|2-Sided|95.0|1.478|14.666||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591617|NCT03114969|2926710|Superiority||Odds Ratio (OR)|5.268||||0.006|2-Sided|95.0|1.615|17.187||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591618|NCT03114969|2926710|Superiority||Odds Ratio (OR)|2.284||||0.143|2-Sided|95.0|0.757|6.895||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591619|NCT03114969|2926710|Superiority||Odds Ratio (OR)|3.483||||0.02|2-Sided|95.0|1.218|9.961||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591620|NCT03114969|2926711|Superiority||Odds Ratio (OR)|5.132||||0.046|2-Sided|95.0|1.031|25.55||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591621|NCT03114969|2926711|Superiority||Odds Ratio (OR)|4.269||||0.078|2-Sided|95.0|0.848|21.489||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591622|NCT03114969|2926711|Superiority||Odds Ratio (OR)|2.929||||0.2|2-Sided|95.0|0.567|15.125||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591623|NCT03114969|2926711|Superiority||Odds Ratio (OR)|2.67||||0.239|2-Sided|95.0|0.521|13.69||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591714|NCT03109184|2926778|Superiority||Effect Size (d)|0.06|||||2-Sided||||||||9-month follow-up between groups effect size of adolescent reported problems in family communication||
1599062|NCT02858401|2938159|Other|||||||1|||||||Fisher Exact||||
1591624|NCT03114969|2926712|Superiority||Odds Ratio (OR)|15.06||||0.063|2-Sided|95.0|0.866|262.042||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591625|NCT03114969|2926712|Superiority||Odds Ratio (OR)|11.907||||0.079|2-Sided|95.0|0.753|188.208||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591626|NCT03114969|2926713|Superiority||Odds Ratio (OR)|9.991||||0.13|2-Sided|95.0|0.508|196.435||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591627|NCT03114969|2926713|Superiority||Odds Ratio (OR)|12.145||||0.09|2-Sided|95.0|0.68|216.818||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591628|NCT03114969|2926714|Superiority||Odds Ratio (OR)|5.408||||0.042|2-Sided|95.0|1.059|27.61||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591629|NCT03114969|2926714|Superiority||Odds Ratio (OR)|3.196||||0.175|2-Sided|95.0|0.596|17.14||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591630|NCT03114969|2926714|Superiority||Odds Ratio (OR)|3.25||||0.166|2-Sided|95.0|0.612|17.244||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591631|NCT03114969|2926714|Superiority||Odds Ratio (OR)|2.089||||0.395|2-Sided|95.0|0.383|11.389||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591632|NCT03114969|2926715|Superiority||Odds Ratio (OR)|9.786||||0.12|2-Sided|95.0|0.553|173.301||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591633|NCT03114969|2926715|Superiority||Odds Ratio (OR)|7.781||||0.147|2-Sided|95.0|0.488|124.117||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591634|NCT03114969|2926716|Superiority||Odds Ratio (OR)|7.603||||0.188|2-Sided|95.0|0.371|155.763||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591635|NCT03114969|2926716|Superiority||Odds Ratio (OR)|21.736||||0.038|2-Sided|95.0|1.183|399.541||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591636|NCT03114969|2926716|Superiority||Odds Ratio (OR)|28.283||||0.024|2-Sided|95.0|1.561|512.532||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591830|NCT03101462|2926971|Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 7|
1591637|NCT03114969|2926716|Superiority||Odds Ratio (OR)|13.717||||0.082|2-Sided|95.0|0.715|263.125||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591638|NCT03114969|2926716|Superiority||Odds Ratio (OR)|10.215||||0.126|2-Sided|95.0|0.519|200.904||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591639|NCT03114969|2926716|Superiority||Odds Ratio (OR)|8.873||||0.141|2-Sided|95.0|0.484|162.775||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591640|NCT03114969|2926716|Superiority||Odds Ratio (OR)|18.776||||0.041|2-Sided|95.0|1.131|311.669||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591641|NCT03114969|2926716|Superiority||Odds Ratio (OR)|20.454||||0.038|2-Sided|95.0|1.19|351.613||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591642|NCT03114969|2926716|Superiority||Odds Ratio (OR)|9.3||||0.128|2-Sided|95.0|0.526|164.465||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591643|NCT03114969|2926716|Superiority||Odds Ratio (OR)|7.347||||0.176|2-Sided|95.0|0.408|132.143||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator. Note: Statistical testing with a small number of events may produce unusual results; odds ratios and confidence intervals should be interpreted with caution.||
1591644|NCT03114969|2926717|Superiority||Odds Ratio (OR)|4.777|||<|0.001|2-Sided|95.0|2.508|9.1||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591645|NCT03114969|2926717|Superiority||Odds Ratio (OR)|3.896|||<|0.001|2-Sided|95.0|2.133|7.118||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591646|NCT03114969|2926717|Superiority||Odds Ratio (OR)|2.748|||<|0.006|2-Sided|95.0|1.328|5.683||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591647|NCT03114969|2926717|Superiority||Odds Ratio (OR)|2.477|||<|0.007|2-Sided|95.0|1.274|4.815||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591648|NCT03114969|2926718|Superiority||Odds Ratio (OR)|5.41|||<|0.001|2-Sided|95.0|2.66|11.005||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591649|NCT03114969|2926718|Superiority||Odds Ratio (OR)|4.217|||<|0.001|2-Sided|95.0|2.019|8.807||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591650|NCT03114969|2926719|Superiority||Odds Ratio (OR)|1.636||||0.232|2-Sided|95.0|0.73|3.664||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591651|NCT03114969|2926719|Superiority||Odds Ratio (OR)|1.931||||0.12|2-Sided|95.0|0.842|4.428||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591652|NCT03114969|2926720|Superiority||Odds Ratio (OR)|3.231|||<|0.001|2-Sided|95.0|1.81|5.766||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591653|NCT03114969|2926720|Superiority||Odds Ratio (OR)|3.84|||<|0.001|2-Sided|95.0|2.135|6.905||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591654|NCT03114969|2926720|Superiority||Odds Ratio (OR)|1.812|||<|0.082|2-Sided|95.0|0.926|3.544||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591655|NCT03114969|2926720|Superiority||Odds Ratio (OR)|2.399|||<|0.008|2-Sided|95.0|1.252|4.596||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591656|NCT03114969|2926721|Superiority||Odds Ratio (OR)|2.523||||0.007|2-Sided|95.0|1.283|4.961||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591657|NCT03114969|2926721|Superiority||Odds Ratio (OR)|1.935||||0.067|2-Sided|95.0|0.955|3.921||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591658|NCT03114969|2926722|Superiority||Odds Ratio (OR)|1.0||||1|2-Sided|95.0|0.438|2.283||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591659|NCT03114969|2926722|Superiority||Odds Ratio (OR)|2.037||||0.081|2-Sided|95.0|0.916|4.528||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.||
1591660|NCT03114969|2926722|Superiority||Odds Ratio (OR)|4.63|||<|0.001|2-Sided|95.0|1.986|10.791||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.||
1591661|NCT03114969|2926722|Superiority||Odds Ratio (OR)|2.848|||<|0.012|2-Sided|95.0|1.264|6.42||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591662|NCT03114969|2926722|Superiority||Odds Ratio (OR)|3.363|||<|0.004|2-Sided|95.0|1.48|7.639||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591663|NCT03114969|2926722|Superiority||Odds Ratio (OR)|1.189|||<|0.69|2-Sided|95.0|0.509|2.775||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591664|NCT03114969|2926722|Superiority||Odds Ratio (OR)|1.747|||<|0.179|2-Sided|95.0|0.775|3.937||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.||
1591665|NCT03114969|2926722|Superiority||Odds Ratio (OR)|2.989|||<|0.016|2-Sided|95.0|1.229|7.272||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.||
1591666|NCT03114969|2926722|Superiority||Odds Ratio (OR)|1.823|||<|0.172|2-Sided|95.0|0.77|4.319||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591667|NCT03114969|2926722|Superiority||Odds Ratio (OR)|2.404|||<|0.045|2-Sided|95.0|1.018|5.676||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591668|NCT03114969|2926723|Superiority||Odds Ratio (OR)|2.957||||0.002|2-Sided|95.0|1.473|5.936||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591669|NCT03114969|2926723|Superiority||Odds Ratio (OR)|4.728|||<|0.001|2-Sided|95.0|2.388|9.364||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591670|NCT03114969|2926723|Superiority||Odds Ratio (OR)|2.391|||<|0.03|2-Sided|95.0|1.088|5.256||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591831|NCT03101462|2926971|Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 45|
1591671|NCT03114969|2926723|Superiority||Odds Ratio (OR)|3.941|||<|0.001|2-Sided|95.0|1.863|8.337||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591672|NCT03114969|2926724|Superiority||Odds Ratio (OR)|5.484|||<|0.001|2-Sided|95.0|2.106|14.284||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591673|NCT03114969|2926724|Superiority||Odds Ratio (OR)|4.887|||<|0.001|2-Sided|95.0|1.851|12.903||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591674|NCT03114969|2926725|Superiority||Odds Ratio (OR)|2.409||||0.122|2-Sided|95.0|0.792|7.331||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591675|NCT03114969|2926725|Superiority||Odds Ratio (OR)|2.503||||0.108|2-Sided|95.0|0.818|7.659||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591676|NCT03114969|2926726|Superiority||Odds Ratio (OR)|2.71||||0.01|2-Sided|95.0|1.274|5.764||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591677|NCT03114969|2926726|Superiority||Odds Ratio (OR)|4.855|||<|0.001|2-Sided|95.0|2.339|10.08||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591678|NCT03114969|2926726|Superiority||Odds Ratio (OR)|2.181|||<|0.069|2-Sided|95.0|0.94|5.059||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591679|NCT03114969|2926726|Superiority||Odds Ratio (OR)|3.995|||<|0.001|2-Sided|95.0|1.808|8.829||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta+[Relvar Ellipta+LAMA] as comparator.||
1591680|NCT03114969|2926727|Superiority||Odds Ratio (OR)|2.642||||0.051|2-Sided|95.0|0.994|7.022||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591681|NCT03114969|2926727|Superiority||Odds Ratio (OR)|2.292||||0.1|2-Sided|95.0|0.853|6.163||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591682|NCT03114969|2926728|Superiority||Odds Ratio (OR)|1.209||||0.761|2-Sided|95.0|0.357|4.095||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591683|NCT03114969|2926728|Superiority||Odds Ratio (OR)|4.165||||0.009|2-Sided|95.0|1.425|12.178||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.||
1591684|NCT03114969|2926728|Superiority||Odds Ratio (OR)|4.418||||0.006|2-Sided|95.0|1.521|12.834||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.||
1591685|NCT03114969|2926728|Superiority||Odds Ratio (OR)|2.979||||0.05|2-Sided|95.0|0.999|8.882||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591686|NCT03114969|2926728|Superiority||Odds Ratio (OR)|5.562||||0.001|2-Sided|95.0|1.932|16.013||Sensitivity analysis was performed using logistic regression with treatment cohort as fixed effect. Time on current primary device was removed from the model for this sensitivity analysis as it was confounded with primary device/treatment cohort.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591687|NCT03114969|2926728|Superiority||Odds Ratio (OR)|1.223||||0.746|2-Sided|95.0|0.361|4.151||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591688|NCT03114969|2926728|Superiority||Odds Ratio (OR)|3.943||||0.012|2-Sided|95.0|1.348|11.534||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.||
1599063|NCT02858401|2938159|Other|||||||1|||||||Fisher Exact||||
1591689|NCT03114969|2926728|Superiority||Odds Ratio (OR)|3.499||||0.026|2-Sided|95.0|1.16|10.555||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Incruse/Anoro Ellipta as comparator.||
1591690|NCT03114969|2926728|Superiority||Odds Ratio (OR)|2.478||||0.114|2-Sided|95.0|0.805|7.632||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591691|NCT03114969|2926728|Superiority||Odds Ratio (OR)|4.657||||0.005|2-Sided|95.0|1.584|13.686||Analysis was performed using logistic regression with treatment cohort as fixed effect and adjusting for the covariate of time on current primary DPI.|Regression, Logistic||Odds ratio was calculated considering Relvar Ellipta as comparator.||
1591692|NCT03110380|2926747|Superiority||Difference in LSM|-18.0||||0.23|2-Sided|95.0|-46.0|11.0|||ANOVA|P-value, difference in least squares means (LSM), and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.|||
1591693|NCT03110380|2926748|Non-Inferiority|It would be concluded that B/F/TAF is noninferior to DTG+F/TAF if the lower bound of the 2-sided 95.001% CI of the difference between treatment groups (B/F/TAF group –DTG+F/TAF group) in the percentage of participants with HIV-1 RNA < 50 copies/mL is greater than −10%.|Difference in Percentages|2.2|||||2-Sided|95.001|-2.3|6.8|||||The differences in percentages of participants between treatment groups and their 95.001% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.||
1591694|NCT03110380|2926749|Superiority|||||||0.37|||||||Fisher Exact||||
1591695|NCT03110380|2926749|Non-Inferiority|A sample size of 260 participants per treatment group would provide at least 90% power to detect a non-inferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the two treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|-0.7|||||2-Sided|95.001|-2.8|1.0|||||The differences in percentages of participants between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the B/F/TAF group is at least 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL as determined by the US FDA-defined snapshot algorithm at Week 48; the alternative hypothesis was that the B/F/TAF group is less than 4% higher than the DTG + F/TAF group with respect to the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48.|
1591696|NCT03109769|2926772|Superiority||Mean Difference (Net)|0.1014||||0.4809|2-Sided||||||Wilcoxon (Mann-Whitney)||"Difference in gingival index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~gingival index at 4 weeks - gingival index at baseline"||
1591697|NCT03109769|2926772|Superiority||Mean Difference (Net)|-0.1177||||0.0002|2-Sided||||||Wilcoxon (Mann-Whitney)||"Difference in gingival index within the first group (mobile phone application) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~gingival index at 4 weeks - gingival index at baseline"||
1591698|NCT03109769|2926772|Superiority|||||||0.0283|||||||Wilcoxon (Mann-Whitney)|||"The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances."|
1591699|NCT03109769|2926773|Superiority||Median Difference (Final Values)|0.0932||||0.0283|2-Sided||||||Wilcoxon (Mann-Whitney)||"Difference in plaque index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~plaque index at 4 weeks - plaque index at baseline"||
1591700|NCT03109769|2926773|Superiority||Mean Difference (Net)|-0.1373||||0.0002|2-Sided||||||Wilcoxon (Mann-Whitney)||"Difference in plaque index within the first group (mobile phone application) at 4 weeks compared to baseline.~The mean difference was calculated as follows:~plaque index at 4 weeks - plaque index at baseline"||
1591701|NCT03109769|2926773|Superiority|||||||0.0444|||||||Wilcoxon (Mann-Whitney)|||"The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.~The null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances."|
1591702|NCT03109184|2926776|Superiority||Effect Size (d)|0.23|||||2-Sided||||||||9-month follow-up between groups effect size of adolescent distress tolerance||
1591703|NCT03109184|2926776|Superiority||Effect Size (d)|-0.11|||||2-Sided||||||||3-month follow-up between groups effect size of adolescent distress tolerance||
1591704|NCT03109184|2926777|Superiority||Effect Size (d)|0.32|||||2-Sided||||||||9-month follow-up between groups effect size of adolescent emotion-regulation||
1591705|NCT03109184|2926777|Superiority||Effect Size (d)|0.15|||||2-Sided||||||||3-month follow-up between groups effect size of adolescent emotion-regulation||
1591706|NCT03109184|2926778|Superiority||Effect Size (d)|-0.1|||||2-Sided||||||||9-month follow-up between groups effect size of parent reported number of relationship topics discussed||
1591707|NCT03109184|2926778|Superiority||Effect Size (d)|0.66|||||2-Sided||||||||3-month follow-up between groups effect size of parent reported number of relationship topics discussed||
1591708|NCT03109184|2926778|Superiority||Effect Size (d)|0.25|||||2-Sided||||||||9-month follow-up between groups effect size of parent reported problems in family communication||
1591709|NCT03109184|2926778|Superiority||Effect Size (d)|-0.15|||||2-Sided||||||||3-month follow-up between groups effect size of parent reported problems in family communication||
1591710|NCT03109184|2926778|Superiority||Effect Size (d)|0.01|||||2-Sided||||||||9-month follow-up between groups effect size of parent reported open family communication||
1591711|NCT03109184|2926778|Superiority||Effect Size (d)|0.15|||||2-Sided||||||||3-month follow-up between groups effect size of parent reported open family communication||
1591715|NCT03109184|2926778|Superiority||Effect Size (d)|-0.15|||||2-Sided||||||||3-month follow-up between groups effect size of adolescent reported problems in family communication||
1591716|NCT03109184|2926778|Superiority||Effect Size (d)|0.06|||||2-Sided||||||||9-month follow-up between groups effect size of adolescent reported open family communication||
1591717|NCT03109184|2926778|Superiority||Effect Size (d)|0.11|||||2-Sided||||||||3-month follow-up between groups effect size of adolescent reported open family communication||
1591718|NCT03109184|2926779|Superiority||Effect Size (d)|0.11|||||2-Sided||||||||9-month follow-up between groups effect size of adolescent long-term self-regulation||
1591719|NCT03109184|2926779|Superiority||Effect Size (d)|-0.11|||||2-Sided||||||||3-month follow-up between groups effect size of adolescent long-term self-regulation||
1591720|NCT03109184|2926779|Superiority||Effect Size (d)|0.36|||||2-Sided||||||||9-month follow-up between groups effect size of adolescent short-term self-regulation||
1591721|NCT03109184|2926779|Superiority||Effect Size (d)|0.09|||||2-Sided||||||||3-month follow-up between groups effect size of adolescent short-term self-regulation||
1591722|NCT03109184|2926780|Superiority||Effect Size (d)|0.2|||||2-Sided||||||||9-month follow-up between groups effect size of parent attitudes support aggression||
1591723|NCT03109184|2926780|Superiority||Effect Size (d)|0.19|||||2-Sided||||||||3-month follow-up between groups effect size of parent attitudes support aggression||
1591724|NCT03109184|2926780|Superiority||Effect Size (d)|-0.17|||||2-Sided||||||||9-month follow-up between groups effect size of adolescent attitudes support aggression||
1591725|NCT03109184|2926780|Superiority||Effect Size (d)|0.01|||||2-Sided||||||||3-month follow-up between groups effect size of adolescent attitudes support aggression||
1591726|NCT03109184|2926781|Superiority||Effect Size (d)|0.01|||||2-Sided||||||||9-month follow-up between groups effect size of general aggression||
1591727|NCT03109184|2926781|Superiority||Effect Size (d)|-0.07|||||2-Sided||||||||3-month follow-up between groups effect size of general aggression||
1591728|NCT03109184|2926782|Superiority||Odds Ratio (OR)|0.86|||||2-Sided||||||||9-month follow-up between groups odds ratio of DV victimization||
1591729|NCT03109184|2926782|Superiority||Odds Ratio (OR)|1.79|||||2-Sided||||||||3-month follow-up between groups odds ratio of DV victimization||
1591730|NCT03109184|2926782|Superiority||Odds Ratio (OR)|0.61|||||2-Sided||||||||9-month follow-up between group odds ratio of DV perpetration||
1591731|NCT03109184|2926782|Superiority||Odds Ratio (OR)|1.21|||||2-Sided||||||||3-Month follow-up between groups odds ratio of DV perpetration||
1591732|NCT03108924|2926787|Other||GMR|0.1|||||2-Sided|90.0|0.07|0.16|||||GMR = GM for Severe RI / GM for Healthy Controls||
1591733|NCT03108924|2926787|Other||GMR|0.31|||||2-Sided|90.0|0.25|0.39|||||GMR = GM for Moderate RI / GM for Healthy Controls||
1591734|NCT03108924|2926789|Other||GMR|0.21|||||2-Sided|95.0|0.13|0.34|||||GMR = GM for ESRD Non-HD / GM for Healthy Controls||
1591735|NCT03108924|2926789|Other||GMR|0.23|||||2-Sided|95.0|0.14|0.35|||||GMR = GM for Severe RI / GM for Healthy Controls||
1591736|NCT03108924|2926789|Other||GMR|0.34|||||2-Sided|95.0|0.23|0.5|||||GMR = GM for Moderate RI / GM for Healthy Controls||
1591737|NCT03108924|2926792|Other||GMR|1.3|||||2-Sided|90.0|0.88|1.9|||||GMR = GM for ESRD / GM for ESRD Non-HD||
1591738|NCT03108924|2926794|Other||GMR|1.9|||||2-Sided|90.0|1.13|3.19|||||GMR = GM for ESRD Non-HD / GM for Healthy Controls||
1591739|NCT03108924|2926794|Other||GMR|1.89|||||2-Sided|95.0|1.1|3.25|||||GMR = GM for Severe RI / GM for Healthy Controls||
1591740|NCT03108924|2926794|Other||GMR|2.09|||||2-Sided|90.0|1.22|3.56|||||GMR = GM for Moderate RI / GM for Healthy Controls||
1591741|NCT03108924|2926797|Other||GMR|0.73|||||2-Sided|90.0|0.52|1.03|||||GMR = GM for ESRD HD / GM for ESRD Non-HD||
1591742|NCT03108924|2926799|Other||GMR|4.43|||||2-Sided|90.0|2.65|7.39|||||GMR = GM for ESRD Non-HD / GM for Healthy Controls||
1591743|NCT03108924|2926799|Other||GMR|4.08|||||2-Sided|90.0|2.49|6.7|||||GMR = GM for Severe RI / GM for Healthy Controls||
1591744|NCT03108924|2926799|Other||GMR|3.23|||||2-Sided|90.0|2.01|5.2|||||GMR = GM for Moderate RI / GM for Healthy Controls||
1591745|NCT03108924|2926802|Other||GMR|0.77|||||2-Sided|90.0|0.54|1.08|||||GMR = GM for ESRD HD / GM for ESRD Non-HD||
1591746|NCT03108924|2926804|Other||GMR|4.74|||||2-Sided|90.0|2.95|7.59|||||GMR = GM for ESRD HD / GM for Healthy Controls||
1591747|NCT03108924|2926804|Other||GMR|4.43|||||2-Sided|95.0|2.82|6.96|||||GMR = GM for Severe RI / GM for Healthy Controls||
1591748|NCT03108924|2926804|Other||GMR|2.98|||||2-Sided|90.0|2.01|4.41|||||GMR = GM for Moderate RI / GM for Healthy Controls||
1591749|NCT03108924|2926807|Other||GMR|0.77|||||2-Sided|90.0|0.53|1.13|||||GMR = GM for ESRD HD / GM for ESRD Non-HD||
1591750|NCT03108027|2926819|Other|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’|Mean Difference (Net)|14.4|||||2-Sided|90.0|3.3|25.5||||||Evening average PEF|
1591751|NCT03108027|2926819|Other|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’|Mean Difference (Net)|58.7||||||90.0|47.5|69.9||||||Evening average PEF|
1591752|NCT03108027|2926819|Other|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’|Mean Difference (Net)|73.1|||||2-Sided|90.0|61.9|84.2||||||Evening average PEF|
1591753|NCT03108027|2926819|Other|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’|Mean Difference (Net)|-14.8|||||2-Sided|90.0|-25.6|-4.1||||||Morning average PEF|
1591754|NCT03108027|2926819|Other|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’|Mean Difference (Net)|86.9|||||2-Sided|90.0|76.1|97.8||||||Morning average PEF|
1591755|NCT03108027|2926819|Other|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’|Mean Difference (Net)|72.1|||||2-Sided|90.0|61.3|82.9||||||Morning average PEF|
1591756|NCT03108027|2926820|Other|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’|Mean Difference (Net)|-0.1141|||||2-Sided|90.0|-0.197|-0.0311|||||||
1591757|NCT03108027|2926820|Other|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’|Mean Difference (Net)|0.7347|||||2-Sided|90.0|0.6469|0.8225|||||||
1591758|NCT03108027|2926820|Other|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’|Mean Difference (Net)|0.6206|||||2-Sided|90.0|0.5335|0.7077|||||||
1591759|NCT03108027|2926821|Other|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’|Mean Difference (Net)|-0.0057|||||2-Sided|90.0|-0.076|0.0647|||||||
1591760|NCT03108027|2926821|Other|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’|Mean Difference (Net)|0.6152|||||2-Sided|90.0|0.5437|0.6868|||||||
1591761|NCT03108027|2926821|Other|A hypothesis test is not planned for this study, inferences are to be performed by interpreting confidence interval of treatment difference.’|Mean Difference (Net)|0.6096|||||2-Sided|90.0|0.538|0.6811|||||||
1591762|NCT03107611|2926826|Equivalence|Equivalence margin: -0.20, +0.20|Difference in proportions|-0.03|||||2-Sided|90.0|-0.12|0.06|||||||
1591763|NCT03107611|2926827|Superiority|||||||0.2874|||||||Fisher Exact||||
1591764|NCT03107611|2926827|Superiority|||||||0.0817|||||||Fisher Exact||||
1591765|NCT03105518|2926844|Superiority||1-way Test, ChiSquare Approximation|0.008||||0.9287|2-Sided||||||Kruskal-Wallis|||VAS at Post Operative Day 3; Follicles ≤10 vs. > 10|
1591766|NCT03105518|2926844|Superiority||1 way Test, ChiSquare Approximation|1.5654||||0.2109|2-Sided||||||Kruskal-Wallis|||VAS at Post Operative Day 2; Follicles ≤10 vs. > 10|
1591767|NCT03105518|2926844|Superiority||1-way Test, ChiSquare Approximation|2.7205||||0.0991|2-Sided||||||Kruskal-Wallis|||VAS at Post Operative Day 1; Follicles ≤10 vs. > 10|
1591768|NCT03105518|2926845|Superiority||1-way Test, ChiSquare Approximation|16.0972|||<|0.0001|2-Sided||||||Kruskal-Wallis|||VAS at Time 60; Follicles ≤10 vs. > 10|
1591769|NCT03105518|2926845|Superiority||1 way Test, ChiSquare Approximation|15.971|||<|0.0001|2-Sided||||||Kruskal-Wallis|||VAS at Time 30; Follicles ≤10 vs. > 10|
1591770|NCT03105518|2926845|Superiority||1 way Test, ChiSquare Approximation|3.6396|||<|0.056|2-Sided||||||Kruskal-Wallis|||VAS at Time 15; Follicles ≤10 vs. > 10|
1591771|NCT03105518|2926845|Superiority||1 way test, chisquare approximation|7.188|||<|0.007|2-Sided||||||Kruskal-Wallis|||VAS at Time 0; Follicles ≤10 vs. > 10|
1591772|NCT03105297|2926886|Superiority or Other|||||||0.0073||||||p-values are from a one sample t-test using SAS (Statistical Analysis System) UNIVARIATE on change from baseline.|t-test, 1 sided||||
1591773|NCT03105297|2926887|Superiority or Other||||||<|0.0001||||||p-values are from a one sample t-test using SAS UNIVARIATE on change from baseline.|t-test, 1 sided||||
1591774|NCT03105297|2926888|Superiority or Other||||||<|0.0001||||||p-values are from a one sample t-test using SAS UNIVARIATE on change from baseline.|t-test, 1 sided||||
1591775|NCT03105297|2926889|Superiority|||||||0.0147||||||p-value for comparing between treatments (strip/no strip) were computed from mixed models with treatment & period as fixed effects, participants as random effects & time as repeated measures effect.|ANCOVA||||
1591776|NCT03103919|2926911|Superiority||Odds Ratio (OR)|1.14|||=|0|2-Sided|95.0|0.23|5.66||P-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment and center.|Regression, Logistic||Odds ratio was calculated as Control Group/Experimental Group (Rotigotine + Standard Care SS / Rotigotine + Standard Care + Kinesia-360™ wearable device SS) calculated using logistic regression with factors for treatment and center.||
1591777|NCT03103919|2926914|Superiority||Mean Difference (Final Values)|-0.2|||=|0|2-Sided|95.0|-0.51|0.11|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|||
1591778|NCT03103919|2926915|Superiority||Mean Difference (Final Values)|0.07|||=|0|2-Sided|95.0|-0.26|0.41|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|||
1591779|NCT03103919|2926916|Superiority||Mean Difference (Final Values)|0.03|||=|0|2-Sided|95.0|-0.25|0.31|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).||
1591780|NCT03103919|2926917|Superiority||Mean Difference (Final Values)|-0.27|||=|0|2-Sided|95.0|-0.79|0.26|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).||
1591781|NCT03103919|2926918|Superiority||Mean Difference (Final Values)|-0.01|||=|0|2-Sided|95.0|-0.33|0.31|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).||
1591782|NCT03103919|2926919|Superiority||Mean Difference (Final Values)|-0.09|||=|0|2-Sided|95.0|-0.75|0.57|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).||
1591783|NCT03103919|2926920|Superiority||Mean Difference (Final Values)|0.15|||=|0|2-Sided|95.0|-0.24|0.53|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).||
1591784|NCT03103919|2926921|Superiority||Mean Difference (Final Values)|-0.07|||=|0|2-Sided|95.0|-0.5|0.35|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).||
1591785|NCT03103919|2926922|Superiority||Mean Difference (Final Values)|-0.18|||=|0|2-Sided|95.0|-0.81|0.45|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).||
1591786|NCT03103919|2926923|Superiority||Mean Difference (Final Values)|0.01|||=|0|2-Sided|95.0|-0.44|0.45|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).||
1591787|NCT03103919|2926924|Superiority||Mean Difference (Final Values)|-4.31|||=|0|2-Sided|95.0|-10.04|1.41|||ANCOVA|The model used an ANCOVA with baseline as a covariate, center as factor, and group as main factor.|The difference presented is Experimental Group (Rotigotine + Standard Care + Kinesia-360™ wearable device FAS) minus Control Group (Rotigotine + Standard Care FAS).||
1591788|NCT03103906|2926932|Other||Difference in proportion|2.56||||0.3334|2-Sided|95.0|-19.99|25.07|||Chi-squared||||
1591789|NCT03102190|2926955|Other||||||||||||||||||The analysis of the safety endpoints will be presented with means and standard deviations of their occurrence within the study population. The safety of the drug will be determined by analyzing the rate of adverse events in both phases of the trial. An occurrence of 10% within the study population will be considered significant.
1591790|NCT03102034|2926960|Superiority||||||<|0.001||||||The threshold for statistical significance is 0.05.|Log Rank||||
1591791|NCT03102034|2926961|Superiority||||||<|0.001||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact||||
1591792|NCT03102034|2926966|Other||% placebo with unsolicited AEs|9.0|||||2-Sided|90.0|0.0|36.0|||||Confidence intervals were Exact Clopper-Pearson.||
1591793|NCT03102034|2926966|Other||% vaccinees with unsolicited AEs|24.0|||||2-Sided|90.0|10.0|44.0|||||Confidence intervals were Exact Clopper-Pearson.||
1591794|NCT03102034|2926967|Other||% placebo recipients with solicited AEs|18.0|||||2-Sided|90.0|3.0|47.0|||||Confidence intervals were Exact Clopper-Pearson.||
1591795|NCT03102034|2926967|Other||% vaccine recipients with solicited AEs|76.0|||||2-Sided|90.0|56.0|90.0|||||Confidence intervals were Exact Clopper-Pearson.||
1591796|NCT03101462|2926968|Other|||||||0.3|||||||Fisher Exact|||Fold increase IgA anti-influenza B HA, Day 7|
1591797|NCT03101462|2926968|Other|||||||0.67|||||||Fisher Exact|||Fold increase IgA anti-H3N2, Day 7|
1591798|NCT03101462|2926968|Other|||||||0.02|||||||Fisher Exact|||Fold increase IgA anti-H1N1 HA, Day 7|
1591799|NCT03101462|2926969|Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Influenza B HA, Day 0 and Day 45|
1591800|NCT03101462|2926969|Other|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H3N2 HA, Day 0 and Day 45|
1591801|NCT03101462|2926969|Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H1N1 HA, Day 0 and Day 45|
1591802|NCT03101462|2926969|Other|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Influenza B HA, Day 0 and Day 45|
1591803|NCT03101462|2926969|Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H3N2 HA, Day 0 and 45|
1591804|NCT03101462|2926969|Other|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Influenza A/H1N1 HA, Day 0 and Day 45|
1591805|NCT03101462|2926970|Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45|
1591806|NCT03101462|2926970|Other|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7|
1591807|NCT03101462|2926970|Other|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45|
1591808|NCT03101462|2926970|Other|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7|
1591809|NCT03101462|2926970|Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45|
1591810|NCT03101462|2926970|Other|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7|
1591811|NCT03101462|2926970|Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45|
1591812|NCT03101462|2926970|Other|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7|
1591813|NCT03101462|2926970|Other|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45|
1591814|NCT03101462|2926970|Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7|
1591815|NCT03101462|2926970|Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45|
1591816|NCT03101462|2926970|Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Flumist CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7|
1591817|NCT03101462|2926970|Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45|
1591818|NCT03101462|2926970|Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Live H3N2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7|
1591819|NCT03101462|2926970|Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45|
1591820|NCT03101462|2926970|Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7|
1591821|NCT03101462|2926970|Other|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45|
1591822|NCT03101462|2926970|Other|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 2 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7|
1591823|NCT03101462|2926970|Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 45|
1591824|NCT03101462|2926970|Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 CD4+/CFSE(low)/IFN-gamma+, Day 0 and Day 7|
1591825|NCT03101462|2926971|Other|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 45|
1591826|NCT03101462|2926971|Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Flumist, Day 0 and Day 7|
1591827|NCT03101462|2926971|Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 45|
1591828|NCT03101462|2926971|Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 7|
1591829|NCT03101462|2926971|Other|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 45|
1599064|NCT02858401|2938159|Other|||||||1|||||||Fisher Exact||||
1591834|NCT03101462|2926971|Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Live H3N2, Day 0 and Day 7|
1591835|NCT03101462|2926971|Other|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 45|
1591836|NCT03101462|2926971|Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Peptide Pool 1 and 2, Day 0 and Day 7|
1591837|NCT03101462|2926972|Other|||||||0.0025|||||||t-test, 2 sided|||Influenza B Day 45|
1591838|NCT03101462|2926972|Other|||||||0.061|||||||t-test, 2 sided|||Influenza B Day 7|
1591839|NCT03101462|2926972|Other|||||||0.25|||||||t-test, 2 sided|||Influenza B Day 0|
1591840|NCT03101462|2926972|Other|||||||0.0052||||||This is the calculated p-value|t-test, 2 sided|||A/H3N2 Day 45|
1591841|NCT03101462|2926972|Other|||||||0.0186||||||This is the calculated p-value|t-test, 2 sided|||A/H3N2 Day 7|
1591842|NCT03101462|2926972|Other|||||||0.63|||||||t-test, 2 sided|||A/H3N2 Day 0|
1591843|NCT03101462|2926972|Other|||||||7.6e-05||||||This is the calculated p-value|t-test, 2 sided|||A/H1N1 Day 45|
1591844|NCT03101462|2926972|Other|||||||0.00082||||||This is the calculated p-value.|t-test, 2 sided|||A/H1N1 Day 7|
1591845|NCT03101462|2926972|Other|ANOVA||||||0.89|||||||t-test, 2 sided|||A/H1N1 Day 0|
1591846|NCT03101293|2926981|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.|LS Mean Ratio|1.154||||0.2745|2-Sided|90.0|0.929|1.433|||ANOVA||||
1591847|NCT03101293|2926982|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% CIs.|LS Mean Ratio|1.121||||0.1763|2-Sided|90.0|0.969|1.298|||ANOVA||||
1591848|NCT03101293|2926983|Equivalence|A linear mixed effect model on the natural log-transformed parameters was performed with regimen, sequence and period as fixed effects and participant nested within sequence as a random effect. The least squares means and difference of least squares means for the log-transformed parameters were exponentiated to obtain the point estimates of the food effect and 90% confidence intervals (CIs).|LS Mean Ratio|1.343||||0.0058|2-Sided|90.0|1.146|1.574|||ANOVA||||
1591849|NCT03101150|2926984|Other||Risk Ratio (RR)|0.43|||<|0.02|2-Sided|95.0|0.19|0.94|||Chi-squared||||
1591850|NCT03101150|2926985|Other||||||<|0.0001|||||||t-test, 2 sided||||
1591851|NCT03101150|2926986|Other|A sample size of minimum 152 was calculated to be able to determine incidence of preeclampsia that is in the range of 8-17% with 80% power assuming an alpha of 5%.|Risk Ratio (RR)|0.163|||<|0.05|2-Sided|95.0|0.02|1.32|||Chi-squared|||Eligible and consented study subjects were randomized according to permuted block design scheme to be allocated in 400 IU arm and 4000 IU arm.|
1591852|NCT03100942|2927009|Superiority|||||||0.3732|||||||Cochran-Mantel-Haenszel||||
1591853|NCT03100942|2927009|Superiority|||||||0.1373|||||||Cochran-Mantel-Haenszel||||
1591854|NCT03100942|2927009|Superiority|||||||0.2082|||||||Cochran-Mantel-Haenszel||||
1591855|NCT03100344|2927029|Superiority||mean difference of percentage changes|-29.2|||<|0.001|2-Sided|95.0|-43.2|-15.2|||Kenward Roger|||Week 24|
1591856|NCT03100344|2927029|Superiority||mean difference of percentage changes|-31.4|||<|0.001|2-Sided|95.0|-45.0|-17.7|||Kenward Roger|||Week 24|
1591857|NCT03100344|2927029|Superiority||mean difference of percentage changes|-23.8|||<|0.001|2-Sided|95.0|-37.7|-9.9|||Kenward Roger|||Week 24|
1591858|NCT03100344|2927030|Superiority||Mean Difference (Final Values)|-2.1|||<|0.001|2-Sided|95.0|-3.1|-1.1|||Kenward Roger|||Week 24|
1591859|NCT03100344|2927030|Superiority||Mean Difference (Final Values)|-2.6|||<|0.001|2-Sided|95.0|-3.6|-1.6|||Kenward Roger|||Week 24|
1591860|NCT03100344|2927030|Superiority||Mean Difference (Final Values)|-1.9|||<|0.001|2-Sided|95.0|-3.0|-0.9|||Kenward Roger|||Week 24|
1591861|NCT03100344|2927031|Superiority||Mean Difference (Final Values)|-2.3|||<|0.001|2-Sided|95.0|-3.3|-1.3|||Kenward Roger|||Week 24|
1591862|NCT03100344|2927031|Superiority||Mean Difference (Final Values)|-2.8|||<|0.001|2-Sided|95.0|-3.8|-1.8|||Kenward Roger|||Week 24|
1591863|NCT03100344|2927031|Superiority||Mean Difference (Final Values)|-2.0|||<|0.001|2-Sided|95.0|-3.0|-1.0|||Kenward Roger|||Week 24|
1591864|NCT03100344|2927033|Superiority||mean difference of percentage changes|-30.0|||<|0.001|2-Sided|95.0|-43.8|-16.2|||Kenward Roger|||Week 24|
1591865|NCT03100344|2927033|Superiority||mean difference of percentage changes|-31.5|||<|0.001|2-Sided|95.0|-44.9|-18.0|||Kenward Roger|||Week 24|
1591866|NCT03100344|2927033|Superiority||mean difference of percentage changes|-22.4|||<|0.002|2-Sided|95.0|-36.1|-8.6|||Kenward Roger|||Week 24|
1591867|NCT03100344|2927033|Superiority||mean difference of percentage changes|-27.9|||<|0.001|2-Sided|95.0|-40.6|-15.2|||Kenward Roger|||Week 20|
1591868|NCT03100344|2927033|Superiority||mean difference of percentage changes|-29.7|||<|0.001|2-Sided|95.0|-42.1|-17.3|||Kenward Roger|||Week 20|
1591869|NCT03100344|2927033|Superiority||mean difference of percentage changes|-21.1|||<|0.001|2-Sided|95.0|-33.7|-8.4|||Kenward Roger|||Week 20|
1591870|NCT03100344|2927033|Superiority||mean difference of percentage changes|-28.7|||<|0.001|2-Sided|95.0|-40.7|-16.8|||Kenward Roger|||Week 16|
1591871|NCT03100344|2927033|Superiority||mean difference of percentage changes|-34.3|||<|0.001|2-Sided|95.0|-46.0|-22.6|||Kenward Roger|||Week 16|
1591872|NCT03100344|2927033|Superiority||mean difference of percentage changes|-20.9|||<|0.001|2-Sided|95.0|-32.8|-8.9|||Kenward Roger|||Week 16|
1591873|NCT03100344|2927033|Superiority||mean difference of percentage changes|-30.2|||<|0.001|2-Sided|95.0|-41.7|-18.7|||Kenward Roger|||Week 12|
1591874|NCT03100344|2927033|Superiority||mean difference of percentage changes|-38.4|||<|0.001|2-Sided|95.0|-49.7|-27.2|||Kenward Roger|||Week 12|
1591875|NCT03100344|2927033|Superiority||mean difference of percentage changes|-24.1|||<|0.001|2-Sided|95.0|-35.6|-12.5|||Kenward Roger|||Week 12|
1591876|NCT03100344|2927033|Superiority||mean difference of percentage changes|-34.1|||<|0.001|2-Sided|95.0|-44.4|-23.8|||Kenward Roger|||Week 8|
1591877|NCT03100344|2927033|Superiority||mean difference of percentage changes|-37.3|||<|0.001|2-Sided|95.0|-47.4|-27.2|||Kenward Roger|||Week 8|
1591878|NCT03100344|2927033|Superiority||mean difference of percentage changes|-22.9|||<|0.001|2-Sided|95.0|-33.2|-12.6|||Kenward Roger|||Week 8|
1591879|NCT03100344|2927033|Superiority||mean difference of percentage changes|-30.7|||<|0.001|2-Sided|95.0|-41.6|-19.9|||Kenward Roger|||Week 4|
1591880|NCT03100344|2927033|Superiority||mean difference of percentage changes|-34.8|||<|0.001|2-Sided|95.0|-45.5|-24.2|||Kenward Roger|||Week 4|
1591881|NCT03100344|2927033|Superiority||mean difference of percentage changes|-21.3|||<|0.001|2-Sided|95.0|-32.1|-10.5|||Kenward Roger|||Week 4|
1591882|NCT03100344|2927033|Superiority||mean difference of percentage changes|-23.8|||<|0.001|2-Sided|95.0|-34.0|-13.6|||Kenward Roger|||Week 2|
1591883|NCT03100344|2927033|Superiority||mean difference of percentage changes|-29.1|||<|0.001|2-Sided|95.0|-39.1|-19.1|||Kenward Roger|||Week 2|
1591884|NCT03100344|2927033|Superiority||mean difference of percentage changes|-21.8|||<|0.001|2-Sided|95.0|-32.0|-11.6|||Kenward Roger|||Week 2|
1591885|NCT03100344|2927033|Superiority||mean difference of percentage changes|-9.4|||<|0.029|2-Sided|95.0|-17.8|-0.9|||Kenward Roger|||Week 1|
1591886|NCT03100344|2927033|Superiority||mean difference of percentage changes|-15.4|||<|0.001|2-Sided|95.0|-23.8|-7.1|||Kenward Roger|||Week 1|
1591887|NCT03100344|2927033|Superiority||mean difference of percentage changes|-10.9|||<|0.012|2-Sided|95.0|-19.4|-2.4|||Kenward Roger|||Week 1|
1591888|NCT03100344|2927034|Superiority||mean difference of percentage changes|-6.8||||0.322|2-Sided|95.0|-20.5|6.8|||Kenward Roger|||Week 24|
1591889|NCT03100344|2927034|Superiority||mean difference of percentage changes|-16.7||||0.016|2-Sided|95.0|-30.2|-3.2|||Kenward Roger|||Week 24|
1591890|NCT03100344|2927034|Superiority||mean difference of percentage changes|-13.6||||0.051|2-Sided|95.0|-27.3|0.0|||Kenward Roger|||Week 24|
1591891|NCT03100344|2927034|Superiority||mean difference of percentage changes|-9.5||||0.18|2-Sided|95.0|-23.4|4.4|||Kenward Roger|||Week 20|
1591892|NCT03100344|2927034|Superiority||mean difference of percentage changes|-15.9||||0.024|2-Sided|95.0|-29.7|-2.1|||Kenward Roger|||Week 20|
1591893|NCT03100344|2927034|Superiority||mean difference of percentage changes|-12.1||||0.09|2-Sided|95.0|-26.0|1.9|||Kenward Roger|||Week 20|
1591894|NCT03100344|2927034|Superiority||mean difference of percentage changes|-10.7||||0.154|2-Sided|95.0|-25.6|4.1|||Kenward Roger|||Week 16|
1591895|NCT03100344|2927034|Superiority||mean difference of percentage changes|-23.7||||0.002|2-Sided|95.0|-38.5|-8.9|||Kenward Roger|||Week 16|
1591896|NCT03100344|2927034|Superiority||mean difference of percentage changes|-13.7||||0.07|2-Sided|95.0|-28.6|1.1|||Kenward Roger|||Week 16|
1591897|NCT03100344|2927034|Superiority||mean difference of percentage changes|-14.7||||0.032|2-Sided|95.0|-28.1|-1.3|||Kenward Roger|||Week 12|
1591898|NCT03100344|2927034|Superiority||mean difference of percentage changes|-23.7|||<|0.001|2-Sided|95.0|-37.1|-10.2|||Kenward Roger|||Week 12|
1591899|NCT03100344|2927034|Superiority||mean difference of percentage changes|-15.9|||<|0.022|2-Sided|95.0|-29.4|-2.3|||Kenward Roger|||Week 12|
1591900|NCT03100344|2927034|Superiority||mean difference of percentage changes|-20.6|||<|0.009|2-Sided|95.0|-36.0|-5.2|||Kenward Roger|||Week 8|
1591901|NCT03100344|2927034|Superiority||mean difference of percentage changes|-23.4|||<|0.003|2-Sided|95.0|-38.9|-7.9|||Kenward Roger|||Week 8|
1591902|NCT03100344|2927034|Superiority||mean difference of percentage changes|-14.8|||<|0.062|2-Sided|95.0|-30.2|0.7|||Kenward Roger|||Week 8|
1591903|NCT03100344|2927034|Superiority||mean difference of percentage changes|-15.3|||<|0.026|2-Sided|95.0|-28.8|-1.8|||Kenward Roger|||Week 4|
1591904|NCT03100344|2927034|Superiority||mean difference of percentage changes|-21.1|||<|0.002|2-Sided|95.0|-34.7|-7.6|||Kenward Roger|||Week 4|
1591905|NCT03100344|2927034|Superiority||mean difference of percentage changes|-14.0|||<|0.044|2-Sided|95.0|-27.5|-0.4|||Kenward Roger|||Week 4|
1591906|NCT03100344|2927034|Superiority||mean difference of percentage changes|-14.8|||<|0.008|2-Sided|95.0|-25.8|-3.8|||Kenward Roger|||Week 2|
1591907|NCT03100344|2927034|Superiority||mean difference of percentage changes|-16.2|||<|0.004|2-Sided|95.0|-27.2|-5.2|||Kenward Roger|||Week 2|
1591908|NCT03100344|2927034|Superiority||mean difference of percentage changes|-9.8|||<|0.084|2-Sided|95.0|-20.9|1.3|||Kenward Roger|||Week 2|
1591909|NCT03100344|2927034|Superiority||mean difference of percentage changes|-15.7|||<|0.002|2-Sided|95.0|-25.6|-5.8|||Kenward Roger|||Week 1|
1591910|NCT03100344|2927034|Superiority||mean difference of percentage changes|-16.9|||<|0.001|2-Sided|95.0|-26.7|-7.0|||Kenward Roger|||Week 1|
1591911|NCT03100344|2927034|Superiority||mean difference of percentage changes|-10.0|||<|0.049|2-Sided|95.0|-20.0|0.0|||Kenward-Rogers|||Week 1|
1591912|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|1.7||||0.826|2-Sided|95.0|-13.5|16.9|||Cochran-Mantel-Haenszel|||Week 24|
1591913|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|15.5||||0.066|2-Sided|95.0|-0.4|31.4|||Cochran-Mantel-Haenszel|||Week 24|
1591914|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|4.2||||0.598|2-Sided|95.0|-11.3|19.8|||Cochran-Mantel-Haenszel|||Week 24|
1591915|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|8.6||||0.254|2-Sided|95.0|-5.9|23.1|||Cochran-Mantel-Haenszel|||Week 20|
1591916|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|17.4||||0.032|2-Sided|95.0|2.0|32.8|||Cochran-Mantel-Haenszel|||Week 20|
1591917|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|4.0||||0.585|2-Sided|95.0|-10.1|18.0|||Cochran-Mantel-Haenszel|||Week 20|
1591918|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|13.9||||0.061|2-Sided|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 16|
1591919|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|20.9||||0.008|2-Sided|95.0|6.1|35.8|||Cochran-Mantel-Haenszel|||Week 16|
1591920|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|4.0||||0.553|2-Sided|95.0|-9.0|16.9|||Cochran-Mantel-Haenszel|||Week 16|
1591921|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|15.6||||0.032|2-Sided|95.0|1.8|29.5|||Cochran-Mantel-Haenszel|||Week 12|
1591922|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|15.6||||0.031|2-Sided|95.0|1.8|29.3|||Cochran-Mantel-Haenszel|||Week 12|
1591923|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|0.2||||0.974|2-Sided|95.0|-11.2|11.6|||Cochran-Mantel-Haenszel|||Week 12|
1591924|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|15.8||||0.009|2-Sided|95.0|4.5|27.0|||Cochran-Mantel-Haenszel|||Week 8|
1591925|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|14.0||||0.016|2-Sided|95.0|3.1|24.8|||Cochran-Mantel-Haenszel|||Week 8|
1591926|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|1.9||||0.632|2-Sided|95.0|-5.6|9.4|||Cochran-Mantel-Haenszel|||Week 8|
1591927|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|8.7||||0.087|2-Sided|95.0|-0.9|18.3|||Cochran-Mantel-Haenszel|||Week 4|
1591928|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|12.2||||0.028|2-Sided|95.0|1.8|22.5|||Cochran-Mantel-Haenszel|||Week 4|
1591929|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|-1.7||||0.583|2-Sided|95.0|-7.6|4.2|||Cochran-Mantel-Haenszel|||Week 4|
1591930|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|-1.8||||0.543|2-Sided|95.0|-7.7|4.0|||Cochran-Mantel-Haenszel|||Week 2|
1591931|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|3.4||||0.413|2-Sided|95.0|-4.7|11.6|||Cochran-Mantel-Haenszel|||Week 2|
1591932|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|-1.8||||0.558|2-Sided|95.0|-7.7|4.1|||Cochran-Mantel-Haenszel|||Week 2|
1591933|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|-1.8||||0.311|2-Sided|95.0|-5.2|1.7|||Cochran-Mantel-Haenszel|||Week 1|
1591934|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|1.7||||0.574|2-Sided|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||Week 1|
1591935|NCT03100344|2927035|Superiority||Mean Difference (Final Values)|0.1||||0.97|2-Sided|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||Week 1|
1591936|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|12.2||||0.083|2-Sided|95.0|-1.3|25.7|||Cochran-Mantel-Haenszel|||Week 24|
1591937|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|19.1||||0.011|2-Sided|95.0|4.9|33.3|||Cochran-Mantel-Haenszel|||Week 24|
1591938|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|12.8||||0.069|2-Sided|95.0|-0.7|26.3|||Cochran-Mantel-Haenszel|||Week 24|
1591939|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|14.0||||0.052|2-Sided|95.0|0.3|27.7|||Cochran-Mantel-Haenszel|||Week 20|
1591940|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|20.9||||0.006|2-Sided|95.0|6.5|35.3|||Cochran-Mantel-Haenszel|||Week 20|
1591941|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|12.9||||0.07|2-Sided|95.0|-0.8|26.6|||Cochran-Mantel-Haenszel|||Week 20|
1591942|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|12.2||||0.069|2-Sided|95.0|-0.7|25.1|||Cochran-Mantel-Haenszel|||Week 16|
1591943|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|24.4||||0.001|2-Sided|95.0|10.3|38.4|||Cochran-Mantel-Haenszel|||Week 16|
1591944|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|9.2||||0.153|2-Sided|95.0|-3.2|21.7|||Cochran-Mantel-Haenszel|||Week 16|
1591945|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|17.5||||0.011|2-Sided|95.0|4.5|30.5|||Cochran-Mantel-Haenszel|||Week 12|
1591946|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|15.6||||0.019|2-Sided|95.0|3.1|28.1|||Cochran-Mantel-Haenszel|||Week 12|
1591947|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|5.6||||0.325|2-Sided|95.0|-5.4|16.5|||Cochran-Mantel-Haenszel|||Week 12|
1591948|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|8.7||||0.054|2-Sided|95.0|0.1|17.4|||Cochran-Mantel-Haenszel|||Week 8|
1591949|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|17.3||||0.002|2-Sided|95.0|6.9|27.8|||Cochran-Mantel-Haenszel|||Week 8|
1591950|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|3.6||||0.307|2-Sided|95.0|-3.2|10.3|||Cochran-Mantel-Haenszel|||Week 8|
1591951|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|1.7||||0.658|2-Sided|95.0|-5.7|9.1|||Cochran-Mantel-Haenszel|||Week 4|
1591952|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|3.4||||0.413|2-Sided|95.0|-4.5|11.4|||Cochran-Mantel-Haenszel|||Week 4|
1591953|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|-1.6||||0.602|2-Sided|95.0|-7.5|4.3|||Cochran-Mantel-Haenszel|||Week 4|
1591954|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|-0.1||||0.978|2-Sided|95.0|-6.8|6.6|||Cochran-Mantel-Haenszel|||Week 2|
1591955|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|-0.1||||0.978|2-Sided|95.0|-6.8|6.6|||Cochran-Mantel-Haenszel|||Week 2|
1591956|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|-3.6||||0.154|2-Sided|95.0|-8.4|1.2|||Cochran-Mantel-Haenszel|||Week 2|
1591957|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|0.0||||0.985|2-Sided|95.0|-4.8|4.8|||Cochran-Mantel-Haenszel|||Week 1|
1591958|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|1.7||||0.574|2-Sided|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||Week 1|
1591959|NCT03100344|2927036|Superiority||Mean Difference (Final Values)|0.1||||0.97|2-Sided|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||Week 1|
1591960|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|17.4||||0.053|2-Sided|95.0|0.3|34.6|||Cochran-Mantel-Haenszel|||Week 24|
1591961|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|19.0||||0.034|2-Sided|95.0|2.2|35.9|||Cochran-Mantel-Haenszel|||Week 24|
1591962|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|10.1||||0.255|2-Sided|95.0|-7.0|27.2|||Cochran-Mantel-Haenszel|||Week 24|
1591963|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|15.7||||0.083|2-Sided|95.0|-1.7|33.1|||Cochran-Mantel-Haenszel|||Week 20|
1591964|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|8.7||||0.327|2-Sided|95.0|-8.4|25.7|||Cochran-Mantel-Haenszel|||Week 20|
1591965|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|10.1||||0.262|2-Sided|95.0|-7.3|27.4|||Cochran-Mantel-Haenszel|||Week 20|
1591966|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|17.4||||0.04|2-Sided|95.0|1.3|33.6|||Cochran-Mantel-Haenszel|||Week 16|
1591967|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|29.6|||<|0.001|2-Sided|95.0|13.2|46.0|||Cochran-Mantel-Haenszel|||Week 16|
1591968|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|13.3|||<|0.111|2-Sided|95.0|-2.8|29.3|||Cochran-Mantel-Haenszel|||Week 16|
1591969|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|19.1|||<|0.22|2-Sided|95.0|3.3|35.0|||Cochran-Mantel-Haenszel|||Week 12|
1591970|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|26.1|||<|0.003|2-Sided|95.0|10.0|42.3|||Cochran-Mantel-Haenszel|||Week 12|
1591971|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|9.7|||<|0.222|2-Sided|95.0|-5.6|25.0|||Cochran-Mantel-Haenszel|||Week 12|
1591972|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|14.1|||<|0.059|2-Sided|95.0|-0.1|28.2|||Cochran-Mantel-Haenszel|||Week 8|
1591973|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|24.5|||<|0.003|2-Sided|95.0|9.4|39.6|||Cochran-Mantel-Haenszel|||Week 8|
1591974|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|5.6|||<|0.404|2-Sided|95.0|-7.5|18.8|||Cochran-Mantel-Haenszel|||Week 8|
1591975|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|21.0|||<|0.002|2-Sided|95.0|8.2|33.9|||Cochran-Mantel-Haenszel|||Week 4|
1591976|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|15.7|||<|0.014|2-Sided|95.0|3.7|27.7|||Cochran-Mantel-Haenszel|||Week 4|
1591977|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|7.4|||<|0.172|2-Sided|95.0|-3.1|18.0|||Cochran-Mantel-Haenszel|||Week 4|
1591978|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|14.0|||<|0.033|2-Sided|95.0|1.5|26.5|||Cochran-Mantel-Haenszel|||Week 2|
1591979|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|3.4|||<|0.521|2-Sided|95.0|-6.9|13.7|||Cochran-Mantel-Haenszel|||Week 2|
1591980|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|2.1|||<|0.69|2-Sided|95.0|-8.0|12.2|||Cochran-Mantel-Haenszel|||Week 2|
1591981|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|1.7|||<|0.658|2-Sided|95.0|-5.8|9.2|||Cochran-Mantel-Haenszel|||Week 1|
1591982|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|1.6|||<|0.668|2-Sided|95.0|-5.8|9.0|||Cochran-Mantel-Haenszel|||Week 1|
1591983|NCT03100344|2927037|Superiority||Mean Difference (Final Values)|0.1|||<|0.979|2-Sided|95.0|-6.8|7.0|||Cochran-Mantel-Haenszel|||Week 1|
1591984|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|10.2||||0.273|2-Sided|95.0|-7.7|28.0|||Cochran-Mantel-Haenszel|||Week 24|
1591985|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|22.4||||0.014|2-Sided|95.0|5.1|39.6|||Cochran-Mantel-Haenszel|||Week 24|
1591986|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|15.9||||0.094|2-Sided|95.0|-2.0|33.8|||Cochran-Mantel-Haenszel|||Week 24|
1591987|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|17.2||||0.064|2-Sided|95.0|-0.6|35.0|||Cochran-Mantel-Haenszel|||Week 20|
1591988|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|26.0||||0.005|2-Sided|95.0|8.6|43.4|||Cochran-Mantel-Haenszel|||Week 20|
1591989|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|17.6||||0.064|2-Sided|95.0|-0.4|35.6|||Cochran-Mantel-Haenszel|||Week 20|
1591990|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|19.1||||0.041|2-Sided|95.0|1.3|36.9|||Cochran-Mantel-Haenszel|||Week 16|
1591991|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|22.6||||0.016|2-Sided|95.0|4.9|40.3|||Cochran-Mantel-Haenszel|||Week 16|
1591992|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|17.6||||0.064|2-Sided|95.0|-0.4|35.6|||Cochran-Mantel-Haenszel|||Week 16|
1591993|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|17.3||||0.063|2-Sided|95.0|-0.5|35.2|||Cochran-Mantel-Haenszel|||Week 12|
1591994|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|27.9||||0.003|2-Sided|95.0|10.4|45.4|||Cochran-Mantel-Haenszel|||Week 12|
1591995|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|19.3||||0.041|2-Sided|95.0|1.3|37.3|||Cochran-Mantel-Haenszel|||Week 12|
1591996|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|27.9||||0.002|2-Sided|95.0|10.7|45.0|||Cochran-Mantel-Haenszel|||Week 8|
1591997|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|27.9||||0.002|2-Sided|95.0|10.7|45.0|||Cochran-Mantel-Haenszel|||Week 8|
1591998|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|20.7||||0.023|2-Sided|95.0|3.3|38.1|||Cochran-Mantel-Haenszel|||Week 8|
1591999|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|17.3||||0.05|2-Sided|95.0|0.5|34.2|||Cochran-Mantel-Haenszel|||Week 4|
1592000|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|26.2||||0.004|2-Sided|95.0|9.3|43.1|||Cochran-Mantel-Haenszel|||Week 4|
1592001|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|15.2||||0.086|2-Sided|95.0|-1.7|32.2|||Cochran-Mantel-Haenszel|||Week 4|
1592002|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|22.7||||0.006|2-Sided|95.0|7.3|38.1|||Cochran-Mantel-Haenszel|||Week 2|
1592003|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|17.4||||0.027|2-Sided|95.0|2.4|32.3|||Cochran-Mantel-Haenszel|||Week 2|
1592004|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|18.5||||0.021|2-Sided|95.0|3.2|33.8|||Cochran-Mantel-Haenszel|||Week 2|
1592005|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|12.0||||0.053|2-Sided|95.0|0.2|23.8|||Cochran-Mantel-Haenszel|||Week 1|
1592006|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|14.0||||0.033|2-Sided|95.0|1.6|26.5|||Cochran-Mantel-Haenszel|||Week 1|
1592007|NCT03100344|2927038|Superiority||Mean Difference (Final Values)|3.8||||0.487|2-Sided|95.0|-6.8|14.3|||Cochran-Mantel-Haenszel|||Week 1|
1592008|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|8.6||||0.254|2-Sided|95.0|-5.9|23.1|||Cochran-Mantel-Haenszel|||Week 20|
1592350|NCT03090100|2927538|Other||Difference in percentage|-0.9|||||2-Sided|95.0|-5.0|3.3|||||||
1592009|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|17.4||||0.032|2-Sided|95.0|2.0|32.8|||Cochran-Mantel-Haenszel|||Week 20|
1592010|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|4.0||||0.585|2-Sided|95.0|-10.1|18.0|||Cochran-Mantel-Haenszel|||Week 20|
1592011|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|13.9||||0.061|2-Sided|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 16|
1592012|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|20.9||||0.008|2-Sided|95.0|6.1|35.8|||Cochran-Mantel-Haenszel|||Week 16|
1592013|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|4.0||||0.553|2-Sided|95.0|-9.0|16.9|||Cochran-Mantel-Haenszel|||Week 16|
1592014|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|13.9||||0.032|2-Sided|95.0|-0.3|28.2|||Cochran-Mantel-Haenszel|||Week 12|
1592015|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|15.6||||0.031|2-Sided|95.0|1.8|29.3|||Cochran-Mantel-Haenszel|||Week 12|
1592016|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|0.2||||0.974|2-Sided|95.0|-11.2|11.6|||Cochran-Mantel-Haenszel|||Week 12|
1592017|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|15.8||||0.009|2-Sided|95.0|4.5|27.0|||Cochran-Mantel-Haenszel|||Week 8|
1592018|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|14.0||||0.016|2-Sided|95.0|3.1|24.8|||Cochran-Mantel-Haenszel|||Week 8|
1592019|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|1.9||||0.632|2-Sided|95.0|-5.6|9.4|||Cochran-Mantel-Haenszel|||Week 8|
1592020|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|8.7||||0.087|2-Sided|95.0|-0.9|18.3|||Cochran-Mantel-Haenszel|||Week 4|
1592021|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|12.2||||0.028|2-Sided|95.0|1.8|22.5|||Cochran-Mantel-Haenszel|||Week 4|
1592022|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|-1.7||||0.583|2-Sided|95.0|-7.6|4.2|||Cochran-Mantel-Haenszel|||Week 4|
1592023|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|-1.8||||0.543|2-Sided|95.0|-7.7|4.0|||Cochran-Mantel-Haenszel|||Week 2|
1592024|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|3.4||||0.413|2-Sided|95.0|-4.7|11.6|||Cochran-Mantel-Haenszel|||Week 2|
1592025|NCT03100344|2927039|Superiority||Mean Difference (Final Values)|-1.8||||0.558|2-Sided|95.0|-7.7|4.1|||Cochran-Mantel-Haenszel|||Week 2|
1592026|NCT03100344|2927039|Other||Mean Difference (Final Values)|1.7||||0.826|2-Sided|95.0|-13.5|16.9|||Cochran-Mantel-Haenszel|||At week 24|
1592027|NCT03100344|2927039|Other||Mean Difference (Final Values)|15.5||||0.066|2-Sided|95.0|-0.4|31.4|||Cochran-Mantel-Haenszel|||At week 24|
1592028|NCT03100344|2927039|Other||Mean Difference (Final Values)|4.2||||0.598|2-Sided|95.0|-11.3|19.8|||Cochran-Mantel-Haenszel|||At week 24|
1592029|NCT03100344|2927039|Other||Mean Difference (Final Values)|-1.8||||0.311|2-Sided|95.0|-5.2|1.7|||Cochran-Mantel-Haenszel|||At week 1|
1592030|NCT03100344|2927039|Other||Mean Difference (Final Values)|1.7||||0.574|2-Sided|95.0|-4.1|7.5|||Cochran-Mantel-Haenszel|||At week 1|
1592031|NCT03100344|2927039|Other||Mean Difference (Final Values)|0.1||||0.97|2-Sided|95.0|-4.9|5.1|||Cochran-Mantel-Haenszel|||At week 1|
1592032|NCT03100344|2927040|Other|mixed-effect model for repeated measures|mean difference of absolute changes|-1.9|||<|0.001|2-Sided|95.0|-3.0|-0.9|||Kenward Roger||||
1592033|NCT03100344|2927040|Other|mixed-effect model for repeated measures|mean difference of absolute changes|-2.3|||<|0.001|2-Sided|95.0|-3.4|-1.3|||Kenward Roger||||
1592034|NCT03100344|2927040|Other|mixed-effect model for repeated measures|mean difference of absolute changes|-2.0|||<|0.001|2-Sided|95.0|-3.1|-1.0|||Kenward Roger||||
1592035|NCT03100344|2927041|Other|mixed-effect model for repeated measures|mean difference of percentage changes|-25.1|||<|0.001|2-Sided|95.0|-38.4|-11.8|||Kenward Roger||||
1592036|NCT03100344|2927041|Other|mixed-effect model for repeated measures|mean difference of percentage changes|-31.7|||<|0.001|2-Sided|95.0|-44.9|-18.6|||Kenward Roger||||
1592037|NCT03100344|2927041|Other|mixed-effect model for repeated measures|mean difference of percentage changes|-24.5|||<|0.001|2-Sided|95.0|-37.8|-11.2|||Kenward Roger||||
1592038|NCT03100344|2927042|Other|mixed-effect model for repeated measures|mean difference of absolute changes|-7.6||||0.058|2-Sided|95.0|-15.4|0.3|||Kenward Roger||||
1592039|NCT03100344|2927042|Other|mixed-effect model for repeated measures|mean difference of absolute changes|-12.8||||0.001|2-Sided|95.0|-20.6|-5.1|||Kenward Roger||||
1592040|NCT03100344|2927042|Other|mixed-effect model for repeated measures|mean difference of absolute changes|-9.6||||0.016|2-Sided|95.0|-17.5|-1.8|||Kenward Roger||||
1592041|NCT03100344|2927043|Other|mixed-effect model for repeated measures|mean difference of percentage changes|-20.0|||<|0.001|2-Sided|95.0|-31.6|-8.3|||Kenward Roger||||
1592042|NCT03100344|2927043|Other|mixed-effect model for repeated measures|mean difference of percentage changes|-11.3|||<|0.058|2-Sided|95.0|-23.1|0.4|||Kenward Roger||||
1592043|NCT03100344|2927043|Other|mixed-effect model for repeated measures|mean difference of percentage changes|-14.4|||<|0.017|2-Sided|95.0|-26.2|-2.7|||Kenward Roger||||
1592044|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|17.4||||0.05|2-Sided|95.0|0.4|34.4|||Cochran-Mantel-Haenszel|||Week 24|
1592045|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|24.3||||0.007|2-Sided|95.0|7.4|41.3|||Cochran-Mantel-Haenszel|||Week 24|
1592046|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|20.9||||0.022|2-Sided|95.0|3.6|38.1|||Cochran-Mantel-Haenszel|||Week 24|
1592047|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|24.5||||0.007|2-Sided|95.0|7.6|41.4|||Cochran-Mantel-Haenszel|||Week 20|
1592048|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|36.7|||<|0.001|2-Sided|95.0|20.1|53.3|||Cochran-Mantel-Haenszel|||Week 20|
1592049|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|26.3|||<|0.004|2-Sided|95.0|9.2|43.5|||Cochran-Mantel-Haenszel|||Week 20|
1592050|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|22.8|||<|0.01|2-Sided|95.0|6.1|39.4|||Cochran-Mantel-Haenszel|||Week 16|
1592051|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|47.2|||<|0.001|2-Sided|95.0|31.2|63.2|||Cochran-Mantel-Haenszel|||Week 16|
1592052|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|33.3|||<|0.001|2-Sided|95.0|16.4|50.2|||Cochran-Mantel-Haenszel|||Week 16|
1592053|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|19.1|||<|0.03|2-Sided|95.0|2.4|35.9|||Cochran-Mantel-Haenszel|||Week 12|
1592054|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|43.6|||<|0.001|2-Sided|95.0|27.4|59.9|||Cochran-Mantel-Haenszel|||Week 12|
1592055|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|24.4|||<|0.007|2-Sided|95.0|7.3|41.4|||Cochran-Mantel-Haenszel|||Week 12|
1592056|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|26.1|||<|0.003|2-Sided|95.0|9.7|42.6|||Cochran-Mantel-Haenszel|||Week 8|
1592057|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|43.7|||<|1|2-Sided|95.0|27.6|59.9|||Cochran-Mantel-Haenszel|||Week 8|
1592058|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|20.6|||<|0.018|2-Sided|95.0|4.2|37.1|||Cochran-Mantel-Haenszel|||Week 8|
1592059|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|31.6|||<|0.001|2-Sided|95.0|17.4|45.8|||Cochran-Mantel-Haenszel|||Week 4|
1592060|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|40.3|||<|0.001|2-Sided|95.0|25.7|54.8|||Cochran-Mantel-Haenszel|||Week 4|
1592061|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|27.6|||<|0.001|2-Sided|95.0|13.5|41.7|||Cochran-Mantel-Haenszel|||Week 4|
1592062|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|19.0|||<|0.011|2-Sided|95.0|4.9|33.1|||Cochran-Mantel-Haenszel|||Week 2|
1592063|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|26.2|||<|0.001|2-Sided|95.0|11.4|40.9|||Cochran-Mantel-Haenszel|||Week 2|
1592064|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|24.0|||<|0.003|2-Sided|95.0|9.3|38.7|||Cochran-Mantel-Haenszel|||Week 2|
1592065|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|5.2|||<|0.307|2-Sided|95.0|-4.7|15.0|||Cochran-Mantel-Haenszel|||Week 1|
1592066|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|12.2|||<|0.042|2-Sided|95.0|0.8|23.6|||Cochran-Mantel-Haenszel|||Week 1|
1592067|NCT03100344|2927044|Superiority||Mean Difference (Final Values)|10.9|||<|0.062|2-Sided|95.0|-0.4|22.2|||Cochran-Mantel-Haenszel|||Week 1|
1592068|NCT03100344|2927045|Superiority||Mean Difference (Final Values)|12.2||||0.154|2-Sided|95.0|-4.2|28.6|||Cochran-Mantel-Haenszel||||
1592069|NCT03100344|2927045|Superiority||Mean Difference (Final Values)|31.4|||<|0.001|2-Sided|95.0|14.7|48.2|||Cochran-Mantel-Haenszel||||
1592070|NCT03100344|2927045|Superiority||Mean Difference (Final Values)|18.9|||<|0.034|2-Sided|95.0|2.0|35.8|||Cochran-Mantel-Haenszel||||
1592071|NCT03100344|2927046|Other|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-6.8||||0.322|2-Sided|95.0|-20.5|6.8|||Kenward Roger||||
1592072|NCT03100344|2927046|Other|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-16.7||||0.016|2-Sided|95.0|-30.2|-3.2|||Kenward Roger||||
1592073|NCT03100344|2927046|Other|mixed-effect model for repeated measures (MMRM)|mean difference of percentage changes|-13.6||||0.051|2-Sided|95.0|-27.3|0.0|||Kenward-Rogers||||
1592074|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|2.1||||0.696|2-Sided|95.0|-8.47|12.67|||ANCOVA|||LDL Cholesterol|
1592075|NCT03100058|2927058|Other|Dose finding study|Median Difference (Net)|2.4||||0.586|2-Sided|95.0|-6.17|10.9|||ANCOVA|||LDL Cholesterol|
1592076|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|2.9||||0.498|2-Sided|95.0|-5.56|11.42|||ANCOVA|||LDL Cholesterol|
1592077|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|8.5||||0.071|2-Sided|95.0|-0.72|17.8|||ANCOVA|||HDL Cholesterol|
1592078|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|3.0||||0.426|2-Sided|95.0|-4.45|10.53|||ANOVA|||HDL Cholesterol|
1592079|NCT03100058|2927058|Other|Dose finding study|Median Difference (Net)|3.3||||0.392|2-Sided|95.0|-4.2|10.7|||ANCOVA|||HDL Cholesterol|
1592080|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|2.5||||0.506|2-Sided|95.0|-4.83|9.79|||ANCOVA|||Total Cholesterol (TC)|
1592081|NCT03100058|2927058|Other|Dose finding study|Median Difference (Net)|2.0||||0.511|2-Sided|95.0|-3.92|7.87|||ANCOVA|||Total Cholesterol (TC)|
1592082|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|2.98||||0.405|2-Sided|95.0|-3.38|8.36|||ANCOVA|||Total Cholesterol (TC)|
1592083|NCT03100058|2927058|Other|Dose finding study|Median Difference (Net)|9.99||||0.566|2-Sided|95.0|-25.39|13.91|||ANCOVA|||Triglycerides (TG)|
1592084|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|8.02||||0.341|2-Sided|95.0|-8.13|23.42|||ANCOVA|||Triglycerides (TG)|
1592085|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|1.9||||0.816|2-Sided|95.0|-13.82|17.54|||ANCOVA|||Triglycerides (TG)|
1592086|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|-1.6||||0.782|2-Sided|95.0|-12.81|9.65|||ANCOVA|||LDL Cholesterol|
1592087|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|-4.8||||0.494|2-Sided|95.0|-18.67|9.03|||ANCOVA|||LDL Cholesterol|
1592088|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|-3.8||||0.58|2-Sided|95.0|-17.22|9.64|||ANCOVA|||LDL Cholesterol|
1592089|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|-8.4||||0.227|2-Sided|95.0|-22.1|5.26|||ANCOVA|||LDL Cholesterol|
1592090|NCT03100058|2927058|Other||Mean Difference (Net)|9.3||||0.097|2-Sided|95.0|-1.68|20.25|||ANCOVA|||LDL Cholesterol|
1592091|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|-4.3||||0.561|2-Sided|95.0|-18.96|10.3|||ANCOVA|||LDL Cholesterol|
1592092|NCT03100058|2927058|Other||Mean Difference (Net)|5.0||||0.487|2-Sided|95.0|-9.08|19.02|||ANCOVA|||LDL Cholesterol|
1592093|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|-3.8||||0.579|2-Sided|95.0|-17.09|9.57|||ANCOVA|||LDL Cholesterol|
1592094|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|7.3||||0.02|2-Sided|95.0|1.14|13.43|||ANCOVA|||HDL Cholesterol|
1592095|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|0.7||||0.847|2-Sided|95.0|-6.87|8.36|||ANCOVA|||HDL Cholesterol|
1592096|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|1.7||||0.649|2-Sided|95.0|-5.67|9.09|||ANCOVA|||HDL Cholesterol|
1592097|NCT03100058|2927058|Other|Dose finding study|Median Difference (Net)|2.2||||0.565|2-Sided|95.0|-5.32|9.73|||ANCOVA|||HDL Cholesterol|
1592098|NCT03100058|2927058|Other|Dose finding study|Median Difference (Net)|7.3||||0.018|2-Sided|95.0|1.23|13.27|||ANCOVA|||HDL Cholesterol|
1592099|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|4.5||||0.269|2-Sided|95.0|-3.5|12.5|||ANCOVA|||HDL Cholesterol|
1592100|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|4.1||||0.288|2-Sided|95.0|-3.52|11.81|||ANCOVA|||HDL Cholesterol|
1592101|NCT03100058|2927058|Other|Dose finding study|Median Difference (Net)|0.0||||0.995|2-Sided|95.0|-7.31|7.36|||ANCOVA|||HDL Cholesterol|
1592102|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|4.1||||0.265|2-Sided|95.0|-3.1|11.26|||ANCOVA|||Total Cholesterol (TC)|
1592103|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|1.7||||0.711|2-Sided|95.0|-7.19|10.53|||ANCOVA|||Total Cholesterol (TC)|
1592104|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|0.4||||0.925|2-Sided|95.0|-8.18|9.01|||ANOVA|||Total Cholesterol (TC)|
1592105|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|-3.3||||0.463|2-Sided|95.0|-12.03|5.48|||ANCOVA|||Total Cholesterol (TC)|
1592106|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|9.9||||0.006|2-Sided|95.0|2.85|16.87|||ANCOVA|||Total Cholesterol (TC)|
1592107|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|0.1||||0.987|2-Sided|95.0|-9.3|9.46|||ANCOVA|||Total Cholesterol (TC)|
1592108|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|2.6||||0.571|2-Sided|95.0|-6.43|11.63|||ANCOVA|||Total Cholesterol (TC)|
1592109|NCT03100058|2927058|Other|Dose finding study|Median Difference (Net)|1.3||||0.764|2-Sided|95.0|-7.22|9.82|||ANCOVA|||Total Cholesterol (TC)|
1592110|NCT03100058|2927058|Other||Mean Difference (Net)|-11.4||||0.049|2-Sided|95.0|-22.71|-0.07|||ANCOVA|||Triglycerides (TG)|
1592111|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|1.4||||0.837|2-Sided|95.0|-12.36|15.26|||ANCOVA|||Triglycerides (TG)|
1592112|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|-2.3||||0.739|2-Sided|95.0|-15.8|11.21|||ANCOVA|||Triglycerides (TG)|
1592113|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|-1.7||||0.806|2-Sided|95.0|-15.38|11.96|||ANCOVA|||Triglycerides (TG)|
1592114|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|-7.0||||0.213|2-Sided|95.0|-18.15|4.06|||ANCOVA|||Triglycerides (TG)|
1592115|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|-15.6||||0.038|2-Sided|95.0|-30.3|-0.86|||ANCOVA|||Triglycerides (TG)|
1592116|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|-2.7||||0.716|2-Sided|95.0|-17.44|11.99|||ANCOVA|||Triglycerides (TG)|
1592117|NCT03100058|2927058|Other|Dose finding study|Mean Difference (Net)|-7.9||||0.254|2-Sided|95.0|-21.37|5.65|||ANCOVA|||Triglycerides (TG)|
1592118|NCT03100058|2927059|Other|Dose finding study|Mean Difference (Net)|0.9||||0.525|2-Sided|95.0|0.65|1.25|||ANCOVA||||
1592119|NCT03100058|2927059|Other|Dose finding study|Median Difference (Net)|0.87||||0.31|2-Sided|95.0|0.67|1.14|||ANCOVA||||
1592120|NCT03100058|2927059|Other|Dose finding study|Median Difference (Net)|0.89||||0.382|2-Sided|95.0|0.68|1.16|||ANCOVA||||
1592121|NCT03100058|2927059|Other|Dose finding study|Mean Difference (Net)|1.06||||0.612|2-Sided|95.0|0.84|1.35|||ANCOVA||||
1592122|NCT03100058|2927059|Other|Dose finding study|Mean Difference (Net)|1.08||||0.602|2-Sided|95.0|0.81|1.45|||ANCOVA||||
1592123|NCT03100058|2927059|Other|Dose finding study|Mean Difference (Net)|1.01||||0.945|2-Sided|95.0|0.76|1.34|||ANCOVA||||
1592124|NCT03100058|2927059|Other|Dose finding study|Mean Difference (Net)|1.1||||0.508|2-Sided|95.0|0.82|1.47|||ANCOVA||||
1592125|NCT03100058|2927059|Other|Dose finding study|Mean Difference (Net)|1.07||||0.587|2-Sided|95.0|0.85|1.35|||ANCOVA||||
1592126|NCT03100058|2927059|Other|Dose finding study|Mean Difference (Net)|1.41||||0.027|2-Sided|95.0|1.04|1.92|||ANCOVA||||
1592127|NCT03100058|2927059|Other|Dose finding study|Mean Difference (Net)|1.15||||0.352|2-Sided|95.0|0.86|1.55|||ANCOVA||||
1592128|NCT03100058|2927059|Other|Dose finding study|Mean Difference (Net)|1.07||||0.632|2-Sided|95.0|0.81|1.42|||ANCOVA||||
1592129|NCT03100058|2927065|Other|Dose finding study|Mean Difference (Net)|-2.8|||<|0.001|2-Sided|95.0|-4.36|-1.24|||ANCOVA||||
1592130|NCT03100058|2927065|Other|Dose finding study|Mean Difference (Net)|-0.6|||<|0.373|2-Sided|95.0|-1.83|0.69|||ANCOVA||||
1592131|NCT03100058|2927065|Other|Dose finding study|Median Difference (Net)|-0.6|||<|0.355|2-Sided|95.0|-1.84|0.66|||ANCOVA||||
1592132|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-2.2||||0.054|2-Sided|95.0|-4.41|0.04|||ANCOVA|||DBP|
1592133|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-0.2||||0.859|2-Sided|95.0|-2.99|2.49|||ANCOVA|||DBP|
1592134|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-1.9||||0.157|2-Sided|95.0|-4.58|0.74|||ANCOVA|||DBP|
1592135|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|0.3||||0.82|2-Sided|95.0|-2.36|2.98|||ANCOVA|||DBP|
1592136|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-1.8||||0.105|2-Sided|95.0|-3.98|0.38|||ANCOVA|||DBP|
1592137|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-2.8||||0.051|2-Sided|95.0|-5.6|0.01|||ANCOVA|||DBP|
1592138|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-0.4||||0.76|2-Sided|95.0|-3.2|2.34|||ANCOVA|||DBP|
1592139|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-0.7||||0.601|2-Sided|95.0|-3.38|1.96|||ANCOVA|||DBP|
1592140|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-3.4||||0.038|2-Sided|95.0|-6.61|-0.19|||ANCOVA|||SBP|
1592141|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-4.1||||0.04|2-Sided|95.0|-8.07|-0.19|||ANCOVA|||SBP|
1592142|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-0.8||||0.678|2-Sided|95.0|-4.65|3.02|||ANCOVA|||SBP|
1592143|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-2.3||||0.245|2-Sided|95.0|-6.12|1.57|||ANCOVA|||SBP|
1592144|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-2.7||||0.089|2-Sided|95.0|-5.86|0.42|||ANCOVA|||SBP|
1592145|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-6.5||||0.002|2-Sided|95.0|-10.52|-2.42|||ANCOVA|||SBP|
1592146|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-3.1||||0.127|2-Sided|95.0|-7.11|0.89|||ANCOVA|||SBP|
1592147|NCT03100058|2927067|Other|Dose finding study|Mean Difference (Net)|-2.8||||0.156|2-Sided|95.0|-6.64|1.07|||ANCOVA|||SBP|
1592148|NCT03100058|2927068|Other|Dose finding study|Mean Difference (Net)|-0.4||||0.03|2-Sided|95.0|-0.72|-0.04|||ANCOVA||||
1592149|NCT03100058|2927068|Other|Dose finding study|Mean Difference (Net)|-0.4||||0.086|2-Sided|95.0|-0.8|0.05|||ANCOVA||||
1592150|NCT03100058|2927068|Other|Dose finding study|Mean Difference (Net)|-0.2||||0.28|2-Sided|95.0|-0.65|0.19|||ANCOVA||||
1592151|NCT03100058|2927068|Other|Dose finding study|Mean Difference (Net)|-0.1||||0.707|2-Sided|95.0|-0.5|0.34|||ANCOVA||||
1592152|NCT03100058|2927068|Other|Dose finding study|Mean Difference (Net)|-0.4||||0.015|2-Sided|95.0|-0.76|-0.08|||ANCOVA||||
1592153|NCT03100058|2927068|Other|Dose finding study|Mean Difference (Net)|-0.4||||0.008|2-Sided|95.0|-1.05|-0.16|||ANCOVA||||
1592154|NCT03100058|2927068|Other|Dose finding study|Median Difference (Net)|-0.2||||0.319|2-Sided|95.0|-0.63|0.21|||ANCOVA||||
1592155|NCT03100058|2927068|Other|Dose finding study|Mean Difference (Net)|0.4||||0.082|2-Sided|95.0|-0.05|0.79|||ANCOVA||||
1592156|NCT03100058|2927069|Other|Dose finding study|Mean Difference (Net)|-1.9||||0.004|2-Sided|95.0|-3.22|-0.61|||ANCOVA||||
1592157|NCT03100058|2927069|Other|Dose finding study|Mean Difference (Net)|-1.8||||0.035|2-Sided|95.0|-3.44|-0.12|||ANCOVA||||
1592158|NCT03100058|2927069|Other|Dose finding study|Mean Difference (Net)|-1.9||||0.02|2-Sided|95.0|-3.54|-0.31|||ANCOVA||||
1592159|NCT03100058|2927069|Other|Dose finding study|Mean Difference (Net)|-1.3||||0.106|2-Sided|95.0|-2.97|0.29|||ANCOVA||||
1592160|NCT03100058|2927069|Other|Dose finding study|Mean Difference (Net)|-1.6||||0.015|2-Sided|95.0|-2.96|-0.33|||ANCOVA||||
1592161|NCT03100058|2927069|Other|Dose finding study|Median Difference (Net)|-2.0||||0.019|2-Sided|95.0|-3.75|-0.34|||ANCOVA||||
1592162|NCT03100058|2927069|Other|Dose finding study|Mean Difference (Net)|-1.0||||0.247|2-Sided|95.0|-2.62|0.68|||ANCOVA||||
1592163|NCT03100058|2927069|Other|Dose finding study|Mean Difference (Net)|1.0||||0.225|2-Sided|95.0|-0.62|2.61|||ANCOVA||||
1592164|NCT03100058|2927070|Other|Dose finding study|Mean Difference (Net)|-2.5||||0.048|2-Sided|95.0|-4.91|-0.02|||ANCOVA||||
1592165|NCT03100058|2927070|Other|Dose finding study|Median Difference (Net)|-2.5||||0.259|2-Sided|95.0|-3.1|0.84|||ANCOVA||||
1592166|NCT03100058|2927070|Other|Dose finding study|Median Difference (Net)|-0.9||||0.391|2-Sided|95.0|-2.82|1.1|||ANCOVA||||
1592167|NCT03100058|2927070|Other|Dose finding study|Mean Difference (Net)|-3.3|||<|0.001|2-Sided|95.0|-5.1|-1.51|||ANCOVA||||
1592168|NCT03100058|2927070|Other|Dose finding study|Median Difference (Net)|-3.5|||<|0.002|2-Sided|95.0|-5.7|-1.3|||ANCOVA||||
1592169|NCT03100058|2927070|Other|Dose finding study|Median Difference (Net)|-3.0|||<|0.006|2-Sided|95.0|-5.18|-0.88|||ANCOVA||||
1592170|NCT03100058|2927070|Other|Dose finding study|Mean Difference (Net)|-1.4|||<|0.206|2-Sided|95.0|-3.56|0.77|||ANCOVA||||
1592171|NCT03100058|2927070|Other|Dose finding study|Median Difference (Net)|-1.4|||<|0.001|2-Sided|95.0|-3.64|0.76|||ANCOVA||||
1592172|NCT03100058|2927070|Other|Dose finding study|Median Difference (Net)|-1.4|||<|0.199|2-Sided|95.0|-3.64|0.76|||ANCOVA||||
1592173|NCT03100058|2927070|Other|Dose finding study|Median Difference (Net)|-0.8|||<|0.47|2-Sided|95.0|-2.96|1.37|||ANCOVA||||
1592174|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|4.55||||0.023|2-Sided|95.0|1.23|16.9|||ANCOVA|||>=5% (T2DM)|
1592175|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|1.71||||0.528|2-Sided|95.0|0.32|9.16|||ANCOVA|||>=5% (T2DM)|
1592176|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|0.55||||0.61|2-Sided|95.0|0.06|5.38|||ANCOVA|||>=5% (T2DM)|
1592177|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|1.64||||0.563|2-Sided|95.0|0.31|8.7|||ANCOVA|||>=5% (T2DM)|
1592178|NCT03100058|2927071|Other|Dose finding test|Odds Ratio (OR)|3.09||||0.098|2-Sided|95.0|0.81|11.75|||ANCOVA|||>=5% (T2DM)|
1592179|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|1.7||||0.546|2-Sided|95.0|0.3|9.49|||ANCOVA|||>=5% (T2DM)|
1592180|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|1.05||||0.958|2-Sided|95.0|0.17|6.68|||ANCOVA|||>=5% (T2DM)|
1592181|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|0.48||||0.528|2-Sided|95.0|0.05|4.78|||ANCOVA|||>=5% (T2DM)|
1592182|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|6.64||||0.023|2-Sided|95.0|1.3|34.0|||ANCOVA|||>=5% (Normoglycemic)|
1592183|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|8.05||||0.027|2-Sided|95.0|1.27|51.09|||ANCOVA|||>=5% (Normoglycemic)|
1592184|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|0.68||||0.751|2-Sided|95.0|0.06|7.62|||ANCOVA|||>=5% (Normoglycemic)|
1592185|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|0.72||||0.788|2-Sided|95.0|0.06|8.1|||ANCOVA|||>=5% (Normoglycemic)|
1592186|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|5.33||||0.033|2-Sided|95.0|1.14|24.83|||ANCOVA|||>=5% (Normoglycemic)|
1592187|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|4.68||||0.095|2-Sided|95.0|0.76|28.7|||ANCOVA|||>=5% (Normoglycemic)|
1592188|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|0.69||||0.763|2-Sided|95.0|0.06|7.85|||ANCOVA|||>=5% (Normoglycemic)|
1592189|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|3.21||||0.227|2-Sided|95.0|0.48|21.28|||ANCOVA|||>=5% (Normoglycemic)|
1592190|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|11.28||||0.005|2-Sided|95.0|2.11|60.46|||ANCOVA|||>=5% (Dysglycemic)|
1592191|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|7.5||||0.032|2-Sided|95.0|1.2|46.99|||ANCOVA|||>=5% (Dysglycemic)|
1592192|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|8.78||||0.022|2-Sided|95.0|1.37|56.44|||ANCOVA|||>=5% (Dysglycemic)|
1592193|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|0.96||||0.976|2-Sided|95.0|0.08|11.72|||ANCOVA|||>=5% (Dysglycemic)|
1592194|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|11.89||||0.003|2-Sided|95.0|2.32|60.93|||ANCOVA|||>=5% (Dysglycemic)|
1592195|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|7.17||||0.041|2-Sided|95.0|1.09|47.27|||ANCOVA|||>=5% (Dysglycemic)|
1592196|NCT03100058|2927071|Other|Dose finding study|Odds Ratio, log|3.94||||0.171|2-Sided|95.0|0.55|28.03|||ANCOVA|||>=5% (Dsyglycemic)|
1592197|NCT03100058|2927071|Other|Dose finding study|Odds Ratio (OR)|6.29||||0.048|2-Sided|95.0|1.02|38.76|||ANCOVA|||>=5% (Dysglycemic)|
1592198|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|3.97||||0.1|2-Sided|95.0|0.77|20.54|||ANCOVA|||>=10%|
1592199|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|3.51||||0.181|2-Sided|95.0|0.56|22.18|||ANCOVA|||>=10%|
1592200|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|1.02||||0.986|2-Sided|95.0|0.09|11.7|||ANCOVA|||>=10%|
1592201|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|1.04||||0.976|2-Sided|95.0|0.09|11.87|||ANCOVA|||>=10%|
1592202|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|2.14||||0.389|2-Sided|95.0|0.38|12.1|||ANCOVA|||>=10%|
1592203|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|1.6||||0.696|2-Sided|95.0|0.15|17.15|||ANCOVA|||>=10%|
1592204|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|2.11||||0.465|2-Sided|95.0|0.28|15.77|||ANCOVA|||>=10%|
1592205|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|1.09||||0.943|2-Sided|95.0|0.1|12.41|||ANCOVA|||>=10%|
1592206|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|6.37|||<|0.001|2-Sided|95.0|2.72|14.93|||ANCOVA|||>=5%|
1592207|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|4.29|||<|0.004|2-Sided|95.0|1.61|11.46|||ANCOVA|||>=5%|
1592208|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|1.94|||<|0.229|2-Sided|95.0|0.66|5.69|||ANCOVA|||>=5%|
1592209|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|1.15|||<|0.812|2-Sided|95.0|0.36|3.74|||ANCOVA|||>=5%|
1592210|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|5.57|||<|0.001|2-Sided|95.0|2.41|12.88|||ANCOVA|||>=5%|
1592211|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|3.69|||<|0.011|2-Sided|95.0|1.35|10.11|||ANCOVA|||>=5%|
1592212|NCT03100058|2927072|Other|Dose finding study|Odds Ratio, log|1.18|||<|0.779|2-Sided|95.0|0.36|3.84|||ANCOVA|||>=5%|
1592213|NCT03100058|2927072|Other|Dose finding study|Odds Ratio (OR)|2.38|||<|0.099|2-Sided|95.0|0.85|6.67|||ANCOVA|||>=5%|
1592214|NCT03100058|2927073|Other|Dose finding study|Mean Difference (Net)|-4.48|||<|0.0001|2-Sided|95.0|-5.54|-3.43|||ANCOVA||||
1592215|NCT03100058|2927073|Other|Dose finding study|Mean Difference (Net)|-4.11|||<|0.0001|2-Sided|95.0|-5.54|-2.68|||ANCOVA||||
1592216|NCT03100058|2927073|Other|Dose finding study|Mean Difference (Net)|-2.74|||<|0.0001|2-Sided|95.0|-4.11|-1.36|||ANCOVA||||
1592217|NCT03100058|2927073|Other|Dose finding study|Mean Difference (Net)|-1.14|||<|0.0001|2-Sided|95.0|-2.53|-0.25|||ANCOVA||||
1592218|NCT03100058|2927073|Other|Dose finding study|Mean Difference (Net)|-4.42|||<|0.0001|2-Sided|95.0|-5.39|-3.44|||ANCOVA||||
1592219|NCT03100058|2927073|Other|Dose finding study|Mean Difference (Net)|-3.3|||<|0.0001|2-Sided|95.0|-4.86|-1.75|||ANCOVA||||
1592220|NCT03100058|2927073|Other|Dose finding study|Median Difference (Net)|-1.93|||<|0.0001|2-Sided|95.0|-3.36|-0.5|||ANCOVA||||
1592221|NCT03100058|2927073|Other|Dose finding study|Mean Difference (Net)|-1.73|||<|0.0001|2-Sided|95.0|-3.17|-0.29|||ANCOVA||||
1592222|NCT03099187|2927108|Superiority||Cox Proportional Hazard|0.0||||0.3231|2-Sided|95.0|0.0|0.0|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|The end point could not be analyzed due to the limited number of events.||
1592223|NCT03099187|2927109|Superiority||Cox Proportional Hazard|1.01||||0.9969|2-Sided|95.0|0.06|16.08|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|||
1592224|NCT03099187|2927110|Superiority||Cox Proportional Hazard|0.79||||0.2726|2-Sided|95.0|0.52|1.2|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|||
1592225|NCT03099187|2927111|Superiority||Cox Proportional Hazard|0.84||||0.366|2-Sided|95.0|0.56|1.24|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|||
1592226|NCT03099187|2927114|Superiority||Hazard Ratio (HR)|1.22||||0.5922|2-Sided|95.0|0.59|2.49|||Log Rank|Log-rank tests based on the time to the first event are to compare the two treatment arms.|Hazard ratios and corresponding 95% CI are calculated by applying Cox-proportional hazard models.||
1592227|NCT03099187|2927115|Superiority||Hodges-Lehmann Median Difference|-1.86||||0.163|2-Sided|95.0|-5.06|1.38|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.|||
1592228|NCT03099187|2927116|Superiority||Hodges-Lehmann Median Difference|-2.0||||0.2995|2-Sided|95.0|-10.0|4.0|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.|||
1592229|NCT03099187|2927117|Superiority||Hodges-Lehmann Median difference|0.29||||0.1872|2-Sided|95.0|-0.45|1.04||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.|||
1592230|NCT03099187|2927118|Superiority||Hodges-Lehmann Median Difference|0.0||||0.7788|2-Sided|95.0|-5.0|5.0|||rank ANCOVA|Analysis of Covariance Changes from baseline to week 24 are compared between the treatment arms using a rank ANCOVA.|||
1592271|NCT03096314|2927247|Superiority||Mean Difference (Final Values)|-2.2|||||2-Sided|95.0|-4.8|0.4|||||||
1592231|NCT03099187|2927119|Superiority||Odds Ratio (OR)|1.03||||0.9198|2-Sided|95.0|0.59|1.78||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA||||
1592232|NCT03099187|2927120|Superiority||Odds Ratio (OR)|0.25||||0.0385|2-Sided|95.0|0.07|0.93||p-value was not adjusted for multiplicity and was provided for descriptive purpose only|rank ANCOVA||||
1592233|NCT03099187|2927121|Superiority||Odds Ratio (OR)|0.44||||0.0114|2-Sided|95.0|0.23|0.84||p-values was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel||||
1592234|NCT03099187|2927122|Superiority||Odds Ratio (OR)|0.42||||0.0006|2-Sided|95.0|0.25|0.69||p-values was not adjusted for multiplicity and was provided for descriptive purpose only|Cochran-Mantel-Haenszel||||
1592235|NCT03099187|2927123|Superiority||Overall Mean Difference|95.3||||0.0018|2-Sided|95.0|35.9|154.6||p-value is not adjusted for multiplicity and is provided for descriptive purpose only.|Student's t-test||||
1592236|NCT03099187|2927124|Superiority|||||||0.0383|||||||rank ANCOVA||||
1592237|NCT03099187|2927125|Superiority||Difference in Group Means|-134.6||||0.6777|2-Sided|95.0|-772.4|503.3||p-value is not adjusted for multiplicity and is provided for descriptive purpose only|t-test, 2 sided|||Mean FVC decline comparison between treatment groups using a Student's t-test with a two-sided significance level of 0.05|
1592238|NCT03098979|2927138|Superiority|||||||0.2701||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques|||
1592239|NCT03098979|2927138|Superiority|||||||0.0918||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques|||
1592240|NCT03098979|2927138|Superiority|||||||0.6232||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques|||
1592241|NCT03098979|2927138|Superiority|||||||0.33||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques|||
1592242|NCT03098979|2927138|Superiority|||||||0.5183||||||Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques.|||
1592243|NCT03097861|2927185|Other||||||<|0.0001|||||||ANCOVA|||Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect|
1592244|NCT03097861|2927185|Other|Treatment p-value is from ANCOVA using SBM count as dependent variable, treatment as fixed effect and baseline count as random effect|||||=|0|||||||ANCOVA||||
1592245|NCT03097614|2927186|Superiority|||||||0.0001|||||||ANCOVA||||
1592246|NCT03097484|2927187|Superiority|||||||0.05||||||0.05 is the calculated p-value (not the threshold for statistical significance)|t-test, 2 sided||||
1592247|NCT03097484|2927188|Superiority|||||||0.03|||||||t-test, 2 sided||||
1592248|NCT03097289|2927205|Non-Inferiority|"The acceptance criterion for the survival (days) of platelets is the demonstration of non inferiority by the rejection of the null hypothesis (H0) defined by the following hypotheses:~Null Hypothesis H0: μd ≤ 0 where μd = μT-0.58 × μC Alternate Hypothesis H1: μd > 0"|Mean Difference (Final Values)|0.8|||||1-Sided|97.5|0.39||||||||
1592249|NCT03097289|2927206|Non-Inferiority|"The acceptance criterion for the recovery (%) of platelets is the demonstration of non-inferiority by the rejection of the Null Hypothesis (H0) defined by the following hypotheses: Null Hypothesis H0: μd ≤ 0 where μd=μT-0.66*μC Alternate Hypothesis H1: μd >~Let Xi = (XTi-0.66*XCi) be a difference if recovery for patient i. The sample mean and standard deviations of these observed differences will be used to construct the lower limit of a 1-sided 97.5% confidence interval."|Mean Difference (Final Values)|8.18|||||1-Sided|97.5|4.03||||||||
1592250|NCT03096314|2927231|Superiority|||||||0.24|||||||Chi-squared||||
1592251|NCT03096314|2927232|Superiority|||||||0.69|||||||Chi-squared||||
1592252|NCT03096314|2927233|Superiority|||||||0.25|||||||Fisher Exact||||
1592253|NCT03096314|2927234|Superiority|||||||0.51|||||||Chi-squared||||
1592254|NCT03096314|2927235|Superiority|||||||0.67|||||||t-test, 2 sided||||
1592255|NCT03096314|2927236|Superiority|||||||0.004|||||||t-test, 2 sided||||
1592256|NCT03096314|2927237|Superiority||Mean Difference (Final Values)|35.5|||||2-Sided|95.0|31.5|39.6|||||||
1592257|NCT03096314|2927238|Superiority||Mean Difference (Final Values)|-0.1|||||2-Sided|95.0|-0.3|0.0|||||||
1592258|NCT03096314|2927239|Superiority||Risk Difference (RD)|0.4|||||2-Sided|95.0|-4.4|5.1|||||||
1592259|NCT03096314|2927240|Superiority||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.2|0.1|||||||
1592260|NCT03096314|2927241|Superiority||Risk Difference (RD)|0.5|||||2-Sided|95.0|-1.9|2.9|||||||
1592261|NCT03096314|2927242|Superiority||Risk Difference (RD)|2.8|||||2-Sided|95.0|-1.7|7.3||||||Severe AKI|
1592262|NCT03096314|2927242|Superiority||Risk Difference (RD)|-0.6|||||2-Sided|95.0|-4.4|3.2||||||Moderate AKI|
1592263|NCT03096314|2927242|Superiority||Risk Difference (RD)|-1.1|||||2-Sided|95.0|-5.6|3.4||||||Mild AKI|
1592264|NCT03096314|2927242|Superiority||Risk Difference (RD)|-1.1|||||2-Sided|95.0|-7.3|5.0||||||No AKI|
1592265|NCT03096314|2927243|Superiority||Risk Difference (RD)|19.1|||||2-Sided|95.0|-2.9|41.1||||||Severe ARDS|
1592266|NCT03096314|2927243|Superiority||Risk Difference (RD)|-25.6|||||2-Sided|95.0|-56.3|5.1||||||Moderate ARDS|
1592267|NCT03096314|2927243|Superiority||Risk Difference (RD)|6.5|||||2-Sided|95.0|-22.0|34.9||||||Mild ARDS|
1592268|NCT03096314|2927244|Superiority||Risk Difference (RD)|0.7|||||2-Sided|95.0|-2.1|3.6|||||||
1592269|NCT03096314|2927245|Superiority||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|0.0|0.1|||||||
1592270|NCT03096314|2927246|Superiority||Mean Difference (Final Values)|-0.8|||||2-Sided|95.0|-2.1|0.5|||||||
1592272|NCT03096314|2927248|Superiority||Mean Difference (Final Values)|-1.4|||||2-Sided|95.0|-2.7|0.0|||||||
1592273|NCT03096314|2927249|Superiority||Risk Difference (RD)|0.3|||||2-Sided|95.0|-5.4|6.0|||||||
1592274|NCT03096314|2927250|Superiority||Risk Difference (RD)|3.7|||||2-Sided|95.0|-0.5|8.0|||||||
1592275|NCT03096314|2927251|Superiority||Risk Difference (RD)|4.3|||||2-Sided|95.0|-0.1|8.6|||||||
1592276|NCT03096314|2927252|Superiority|||||||0.26|||||||Generalized linear model||||
1592277|NCT03095638|2927320|Other||Ratio|1.7974|||||2-Sided|90.0|1.6263|1.9865|||||||
1592278|NCT03095638|2927320|Other||Ratio|1.7933|||||2-Sided|90.0|1.6226|1.9819|||||||
1592279|NCT03095638|2927321|Other||Ratio|1.5519|||||2-Sided|90.0|1.4317|1.6822|||||||
1592280|NCT03095638|2927321|Other||Ratio|1.6292|||||2-Sided|90.0|1.503|1.7661|||||||
1592281|NCT03095638|2927322|Other||Ratio|1.5448|||||2-Sided|90.0|1.4253|1.6743|||||||
1592282|NCT03095638|2927322|Other||Ratio|1.6242|||||2-Sided|90.0|1.4986|1.7604|||||||
1592283|NCT03095638|2927323|Other||Ration|1.0329|||||2-Sided|90.0|0.8623|1.2373|||||||
1592284|NCT03095638|2927324|Other||Ratio|1.0121|||||2-Sided|90.0|0.8648|1.1845|||||||
1592285|NCT03095638|2927325|Other||Ratio|1.0084|||||2-Sided|90.0|0.8626|1.1789|||||||
1592286|NCT03095521|2927341|Superiority|||||||0.072|||||||t-test, 2 sided|||change from baseline, 2 groups|
1592287|NCT03095521|2927343|Superiority|||||||0.482|||||||Wilcoxon (Mann-Whitney)||||
1592288|NCT03095521|2927346|Non-Inferiority|two-sided 95% CIs estimation used to confirm non-inferior efficacy in primary endpoint. A non-inferiority conclusion was made relating to the primary parameter only.||||||0.028|||||||Fisher Exact|||Arm Angal, Arm Antiangin|
1592289|NCT03095508|2927347|Non-Inferiority|non-inferiority margin 14.5% absolute difference between percentages in group A and B|Risk Difference (RD)|0.14||||1e-05|2-Sided|95.0|0.03|0.24||p- value for superiority: 0.021|Fisher Exact|||p1=proportion of patients without sore throat at Day 4 in Arm A p2=proportion of patients without sore throat at Day 4 in Arm B Н0: p1 – p2 ≤ -0.145|
1592290|NCT03095508|2927348|Superiority|||||||0.188|||||||Wilcoxon (Mann-Whitney)||||
1592291|NCT03095508|2927349|Superiority|||||||0.145|||||||t-test, 2 sided||||
1592292|NCT03095508|2927350|Superiority|||||||1|||||||Fisher Exact||||
1592293|NCT03095508|2927352|Superiority|||||||0.446|||||||Fisher Exact||||
1592294|NCT03095027|2927362|Non-Inferiority|The pre-specified non-inferiority margin is 0.05. With a sample size of 10, there was approximately 80% power to reject the null hypothesis of inferiority in visual acuity with assumed standard deviation of 0.0474 (one-sided alpha=0.05)|LSM Difference|0.0|Standard Error of the Mean|0.0|||1-Sided|95.0||0.01|||||||
1592295|NCT03094195|2927374|Superiority||LS mean difference|0.1|Standard Error of the Mean|0.53||0.914|2-Sided|95.0|-1.0|1.1|||ANCOVA||||
1592296|NCT03094195|2927374|Superiority||LS mean difference|0.6|Standard Error of the Mean|0.49||0.225|2-Sided|95.0|-0.4|1.6|||ANCOVA||||
1592297|NCT03094195|2927376|Superiority||Odds Ratio (OR)|1.4||||0.653|2-Sided|95.0|0.4|4.5|||Regression, Logistic||||
1592298|NCT03094195|2927376|Superiority||Odds Ratio (OR)|0.9||||0.8|2-Sided|95.0|0.3|3.2|||Regression, Logistic||||
1592299|NCT03094195|2927377|Superiority||Odds Ratio (OR)|1.4||||0.609|2-Sided|95.0|0.4|4.5|||Regression, Logistic||||
1592300|NCT03094195|2927377|Superiority||Odds Ratio (OR)|0.9||||0.908|2-Sided|95.0|0.3|3.2|||Regression, Logistic||||
1592301|NCT03094195|2927381|Superiority||LS Mean|-0.5|Standard Error of the Mean|0.54||0.35|2-Sided|95.0|-1.6|0.6|||ANCOVA|Multiplicity adjustment for the pairwise comparisons has been performed using the Hochberg procedure. Adjusted p-value 0.689|||
1592302|NCT03094195|2927381|Superiority||least squares mean|-0.2|Standard Error of the Mean|0.56||0.689|2-Sided|95.0|-1.3|0.9|||ANCOVA|Multiplicity adjustment for the pairwise comparisons has been performed using the Hochberg procedure. Adjusted p-value 0.689|||
1592303|NCT03093181|2927395|Superiority||Mean Difference (Final Values)|-0.01||||0.8253|2-Sided|95.0|-0.15|0.12|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Non-Polarised Image.|
1592304|NCT03093181|2927395|Superiority||Mean Difference (Final Values)|0.15||||0.0224|2-Sided|95.0|0.02|0.28|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Non-Polarised Image.|
1592305|NCT03093181|2927395|Superiority||Mean Difference (Final Values)|0.01||||0.8887|2-Sided|95.0|-0.12|0.14|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Polarised Image.|
1592306|NCT03093181|2927395|Superiority||Mean Difference (Final Values)|0.15||||0.0279|2-Sided|95.0|0.02|0.28|||ANOVA|ANOVA= average rate over all raters including effects of treatment and age stratum.||Analysis of Lay Person Assessment Polarised Image.|
1592307|NCT03093181|2927396|Superiority||Odds Ratio (OR)|0.94||||0.8319|2-Sided|95.0|0.55|1.63|||Odds Ratio|||Analysis of Lay Person Assessment Non-Polarised Image.|
1592308|NCT03093181|2927396|Superiority||Odds Ratio (OR)|1.9||||0.0181|2-Sided|95.0|1.12|3.25|||Odds Ratio|||Analysis of Lay Person Assessment Non-Polarised Image.|
1592309|NCT03093181|2927396|Superiority||Odds Ratio (OR)|1.04||||0.8931|2-Sided|95.0|0.61|1.78|||Odds Ratio|||Analysis of Lay Person Assessment Polarised Image.|
1592310|NCT03093181|2927396|Superiority||Odds Ratio (OR)|1.85||||0.0243|2-Sided|95.0|1.08|3.15|||Odds Ratio|||Analysis of Lay Person Assessment Polarised Image.|
1592311|NCT03093181|2927398|Superiority||LS mean difference|1.51||||0.2262|2-Sided|95.0|-0.95|3.96||From ANCOVA with treatment main effect, age stratum and baseline as covariates.|ANCOVA||Difference is first named treatment (test product) minus second named treatment (negative control) such that a positive value favors the first named treatment (test product).||
1592312|NCT03093181|2927398|Superiority||Least square (LS) mean difference|3.12||||0.0128|2-Sided|95.0|0.68|5.56||From Analysis of covariance (ANCOVA) with treatment main effect, age stratum and baseline as covariates|ANCOVA||Difference is first named treatment (test product) minus second named treatment (negative control) such that a positive value favors the first named treatment (test product).||
1592347|NCT03091751|2927478|Other||Mean Difference (Final Values)|10.41||||0.77|2-Sided|95.0|-224.88|245.7|||t-test, 1 sided||||
1592313|NCT03092726|2927448|Superiority||Odds Ratio (OR)|0.8||||0.407|2-Sided|90.0|0.52|1.24||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||EOT: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.|
1592314|NCT03092726|2927448|Superiority||Odds Ratio (OR)|0.78||||0.357|2-Sided|90.0|0.5|1.21||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 8: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.|
1592315|NCT03092726|2927448|Superiority||Odds Ratio (OR)|0.79||||0.368|2-Sided|90.0|0.5|1.22||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 4: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.|
1592316|NCT03092726|2927448|Superiority||Odds Ratio (OR)|1.07||||0.811|2-Sided|90.0|0.68|1.67||2-sided p-value is for the comparison of ASP8062 30 mg with placebo from the above described proportional odds model.|Proportional Odds model|||Week 2: Odds ratio of ASP8062 30 mg versus placebo, associated 90% 2-sided CI and p-value was estimated using a proportional odds model including treatment group as a factor.|
1592317|NCT03092726|2927449|Superiority||LSM Difference|0.17|Standard Error of the Mean|0.67||0.603|2-Sided|90.0|-0.93|1.28||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|
1592318|NCT03092726|2927449|Superiority||LSM Difference|0.06|Standard Error of the Mean|0.71||0.531|2-Sided|90.0|-1.11|1.22||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.|
1592319|NCT03092726|2927449|Superiority||LSM Difference|-0.17|Standard Error of the Mean|0.73||0.41|2-Sided|90.0|-1.37|1.04||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.|
1592320|NCT03092726|2927449|Superiority||LSM Difference|0.19|Standard Error of the Mean|0.59||0.629|2-Sided|90.0|-0.78|1.17||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.|
1592321|NCT03092726|2927450|Superiority||LSM Difference|1.68|Standard Error of the Mean|2.43||0.755|2-Sided|90.0|-2.34|5.69||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|
1592322|NCT03092726|2927450|Superiority||LSM Difference|1.7|Standard Error of the Mean|2.57||0.745|2-Sided|90.0|-2.56|5.96||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.|
1592323|NCT03092726|2927450|Superiority||LSM Difference|1.46|Standard Error of the Mean|2.08||0.758|2-Sided|90.0|-1.98|4.91||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.|
1592324|NCT03092726|2927450|Superiority||LSM Difference|0.16|Standard Error of the Mean|1.85||0.534|2-Sided|90.0|-2.9|3.22||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.|
1592325|NCT03092726|2927451|Superiority||LSM Difference|1.09|Standard Error of the Mean|2.57||0.664|2-Sided|90.0|-3.16|5.34||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described ANCOVA model.|ANCOVA|||EOT: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using an ANCOVA model that was performed with change from baseline at the EOT timepoint as response, treatment and center (pooled where necessary) as fixed effects and baseline as a covariate.|
1592348|NCT03091673|2927483|Other||||||<|0.001||||||P-value was computed using a t-test to determine if change in plasma glucose from baseline to 30 minutes was zero.|t-test, 2 sided||||
1592349|NCT03091179|2927520|Equivalence|P value was calculated using the means and standard deviations for each of the patient characteristics.||||||0.006|||||||t-test, 2 sided||||
1592326|NCT03092726|2927451|Superiority||LSM Difference|0.86|Standard Error of the Mean|2.68||0.626|2-Sided|90.0|-3.57|5.3|||MMRM|||Week 8: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.|
1592327|NCT03092726|2927451|Superiority||LSM Difference|-0.64|Standard Error of the Mean|2.34||0.393|2-Sided|90.0|-4.51|3.24||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 4: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.|
1592328|NCT03092726|2927451|Superiority||LSM Difference|-0.68|Standard Error of the Mean|2.03||0.369|2-Sided|90.0|-4.05|2.68||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Week 2: Differences of LS means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a MMRM model with change from baseline to weeks 2, 4 and 8 as response, treatment, center (pooled where necessary), time (study weeks 2, 4 and 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.|
1592329|NCT03092726|2927452|Superiority||Differences of percentages|4.3||||0.269|2-Sided|90.0|-7.9|16.4||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||EOT: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.|
1592330|NCT03092726|2927452|Superiority||Differences of percentages|2.2||||0.412|2-Sided|90.0|-10.0|14.4||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||Week 8: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.|
1592331|NCT03092726|2927453|Superiority||Differences of percentages|-5.6||||0.838|2-Sided|90.0|-17.7|6.7||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||EOT: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.|
1592332|NCT03092726|2927453|Superiority||Difference of percentages|-6.6||||0.874|2-Sided|90.0|-18.7|5.7||1-sided p-value is for comparison of ASP8062 30 mg with placebo using Fisher's Exact method.|Fisher Exact|||Week 8: Differences of the percentages were calculated by subtracting the percentage of placebo group from the percentage of ASP8062 30 mg group. Confidence Interval (CI) for each treatment group and the difference of the percentages was an exact unconditional confidence interval based on Santner-Snell approach.|
1592333|NCT03092726|2927457|Superiority||LS Mean (LSM) Difference|0.06|Standard Error of the Mean|0.26||0.59|2-Sided|90.0|-0.38|0.5||1-sided p-value is for comparison of ASP8062 30 mg with placebo from the above described MMRM model.|MMRM|||Differences of least squares (LS) means were calculated by subtracting the LS mean of placebo group from the LS mean of ASP8062 30 mg group using a mixed-effect, repeated measures (MMRM) model with change from baseline to each week from weeks 1 to 8 as response, treatment, center (pooled where necessary), time (study weeks 1 to 8) and treatment-by-time interaction as fixed effects, baseline and baseline-by-time interaction as covariates.|
1592334|NCT03092375|2927465|Other|Study is not powered|Logistic regression contrast estimate|0.977||||0.265|2-Sided|95.0|-0.74|2.694|||Chi-squared|||Comparison of 12 weeks vs 16 weeks in Genotype 1b vs non-1b|
1592335|NCT03092375|2927465|Other|Study is not powered to compare efficacy of 12 wks vs 16 weeks of treatment|Logistic regression contrast estimate|0.89||||0.89|2-Sided|95.0|-1.239|1.076|||Chi-squared|Logistic regression contrast estimates with Wald confidence intervals and Chi-square p values|Difference in proportion of SVR12 rates for 12 vs 16 weeks on mITT Comparing Cirrhotic subjects versus non-cirrhotic subjects.||
1592336|NCT03092375|2927465|Other|Study was not powered to compare efficacy|Logistic Regression Contrast Estimate|-0.812||||0.161|2-Sided|95.0|-1.947|0.323|||Chi-squared|Logistic regression contrast estimates with Wald confidence intervals and Chi-square p values|Comparison of Arm Pair A/C versus B/D overall on mITT population||
1592337|NCT03092375|2927466|Other||Mean Difference (Final Values)|-1.81|||||2-Sided|95.0|-13.85|10.22||||||Excludes re-infection and death|
1592338|NCT03092375|2927467|Other|Difference in percentage of subjects with on-treatment virologic failure between Arms C and D will be summarized with two-sided 95% Wilson score intervals|Mean Difference (Final Values)|9.52|||||2-Sided|95.0|-3.03|22.08|||||||
1592339|NCT03092375|2927468|Other|The difference in the percentage of subjects with post-treatment relapse between Arms A and B are summarized with two-sided 95% Wilson score intervals.|Mean Difference (Final Values)|-2.5|||||2-Sided|95.0|-10.49|5.49|||||||
1592340|NCT03092375|2927469|Other|Study is not intended to be powered|Mean Difference (Final Values)|-0.76|||||2-Sided|95.0|-9.48|5.12|||||Excludes re-infection and death|The difference in the percentage of subjects with on-treatment virologic failure (Defined as increase of >1 log10 IU/mL above nadir during treatment, or HCV RNA >= 15 IU/mL at end of treatment with at least 6 weeks of treatment between Arms A and B are summarized with two-sided 95% Wilson score intervals.|
1592341|NCT03091777|2927473|Superiority||||||<|0.001|||||||Chi-squared, Corrected||||
1592342|NCT03091777|2927473|Superiority||||||<|0.001|||||||Chi-squared, Corrected||||
1592343|NCT03091751|2927474|Other||Mean Difference (Final Values)|-7.609||||0.02|2-Sided|95.0|-13.344|-1.879|||t-test, 1 sided||||
1592344|NCT03091751|2927475|Other||Mean Difference (Final Values)|-0.0058||||0.16|2-Sided|95.0|-0.0119|0.0003|||t-test, 1 sided||||
1592345|NCT03091751|2927476|Other||Mean Difference (Final Values)|-3.3||||0.3|2-Sided|95.0|-8.9|2.3|||t-test, 1 sided||||
1592346|NCT03091751|2927477|Other||Mean Difference (Final Values)|0.3068||||0.002|2-Sided|95.0|0.1501|0.4635|||t-test, 1 sided||||
1592351|NCT03090100|2927539|Other||Difference in percentage|-0.1|||||2-Sided|95.0|-4.2|3.9|||||||
1592352|NCT03090100|2927540|Other||Difference in percentage|9.8|||||2-Sided|95.0|4.2|15.3|||||||
1592353|NCT03090100|2927541|Other||Difference in percentage|-1.4|||||2-Sided|95.0|-6.2|3.4|||||||
1592354|NCT03090100|2927542|Other||Difference in percentage|-0.3|||||2-Sided|95.0|-3.5|3.1|||||||
1592355|NCT03090100|2927543|Other||Difference in percentage|7.8|||||2-Sided|95.0|2.3|13.2|||||||
1592356|NCT03090100|2927544|Other||Difference in percentage|9.7|||||2-Sided|95.0|4.9|14.5|||||||
1592357|NCT03090100|2927545|Other||Difference in percentage|11.6|||||2-Sided|95.0|5.8|17.4|||||||
1592358|NCT03090100|2927546|Other||Difference in percentage|9.7|||||2-Sided|95.0|3.8|15.5|||||||
1592359|NCT03090100|2927547|Other||Difference in percentage|-2.3|||||2-Sided|95.0|-6.0|1.2|||||||
1592360|NCT03090100|2927548|Other||Difference in percentage|-7.0|||||2-Sided|95.0|-12.2|-1.7|||||||
1592361|NCT03090100|2927549|Superiority|||||||0.062|||||||Cochran-Mantel-Haenszel||||
1592362|NCT03090100|2927549|Non-Inferiority|Non-inferiority margin of 10%|Difference in percentage|4.3|||<|0.001|2-Sided|95.0|-0.2|8.9|||z-test||||
1592363|NCT03090100|2927550|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1592364|NCT03090100|2927550|Non-Inferiority|Non-inferiority margin of 10%|Difference in percentage|14.2|||<|0.001|2-Sided|95.0|9.2|19.2|||z-test||||
1592365|NCT03089580|2927561|Superiority|The p-value results from a test of the hypothesis that the change in OSDI from visit 1 does not differ from zero. Change distributions that met normal distribution test criteria (Shapiro-Wilk p-value >0.05) were tested with the paired Student’s t-test; non-normal change distributions (at visits 2 & 4) were tested with the non-parametric Wilcoxon signed rank test.||||||0.2026|||||||paired t test||||
1592366|NCT03089580|2927562|Superiority|Paired, Student’s t-test was used to contrast the outcome variable of TBUT in the treated eye versus the sham eye from visit 1 to visit 5. The null hypothesis to be tested is one of no change from pre- to post treatment, with a Type I error probability of 0.05 for the primary outcome assessment. The pattern of change over the 4 treatment visits in these continuous variables will be assessed using mixed, linear regression. SAS version 9.4 statistical software (SAS Institute, Cary, NC) was used.||||||0.3|||||||paired t test|||The primary study outcome of pre to post change in TBUT within the treated eye and also the untreated, control eye dictated the use of a paired statistical approach to sample size estimation. Clinically relevant pre to post TBUT increase of 3 seconds with a standard deviation of 4.5 seconds was used. Type I and II error estimates used were standard for a non-pivotal study, 0.05 & 0.20. The estimated the sample size needed detect this difference in TBUT is 27 subjects.|
1592367|NCT03088267|2927570|Superiority||Mean Difference (Final Values)|60.3||||0.0003|2-Sided|95.0|32.91|87.75|||ANCOVA|||Comparison at 3 hours postdose|
1592368|NCT03088267|2927570|Superiority||Mean Difference (Final Values)|18.8||||0.1128|2-Sided|95.0|-4.94|42.5|||ANCOVA|||Comparison at 30 minutes post-dose|
1592369|NCT03088267|2927571|Superiority||Mean Difference (Final Values)|-8.6||||0.0118|2-Sided|95.0|-14.94|-2.17|||ANCOVA||||
1592370|NCT03088137|2927572|Superiority||Mean Difference (Final Values)|-0.62||||0.507|2-Sided|95.0|-24.3|11.9|||Chi-squared|||95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.|
1592371|NCT03088137|2927573|Superiority||Mean Difference (Final Values)|-2.0||||0.833|2-Sided|95.0|-21.0|17.0|||Chi-squared|||95% confidence intervals (CIs) of point estimates were calculated using the exact binomial distribution (Clopper-Pearson method) for proportions.|
1592372|NCT03088137|2927576|Superiority|||||||0.644|||||||Wilcoxon (Mann-Whitney)||||
1592373|NCT03088137|2927577|Superiority||Mean Difference (Final Values)|0.018|Standard Deviation|0.201||0.629|2-Sided|95.0|-0.379|0.416|||Wilcoxon (Mann-Whitney)||||
1592374|NCT03088137|2927578|Superiority||Mean Difference (Final Values)|14.9|Standard Deviation|49.8||0.488|2-Sided|95.0|-83.9|113.6|||Wilcoxon (Mann-Whitney)||||
1592375|NCT03088137|2927579|Superiority|||||||0.623|||||||ANOVA||||
1592376|NCT03088137|2927580|Superiority||Mean Difference (Final Values)|0.636|Standard Deviation|1.19||0.445|2-Sided|95.0|-2.995|1.723|||Wilcoxon (Mann-Whitney)||||
1592377|NCT03088137|2927581|Superiority||Mean Difference (Final Values)|0.218|Standard Deviation|1.129||0.617|2-Sided|95.0|-2.455|2.019|||Wilcoxon (Mann-Whitney)||||
1592378|NCT03088137|2927582|Superiority||Mean Difference (Final Values)|0.709|Standard Deviation|1.067||0.806|2-Sided|95.0|-1.405|2.824|||Wilcoxon (Mann-Whitney)||||
1592379|NCT03088137|2927583|Equivalence|Study power of at least 80% at a significance level (alpha error) 5% and a pre-determined clinical equivalence margin of +/- 3.4 oocytes for the relevant population.|Mean Difference (Final Values)|0.546|Standard Deviation|1.297||0.002|2-Sided|95.0|-2.026|3.116|||Wilcoxon (Mann-Whitney)||||
1592380|NCT03087643|2927584|Other|||||||0.0476|||||||Mixed Models Analysis||||
1592381|NCT03087643|2927585|Other|||||||0.0451|||||||Mixed Models Analysis||||
1592382|NCT03087643|2927586|Other|||||||0.0321|||||||Mixed Models Analysis||||
1592383|NCT03087643|2927587|Other|||||||0.0283|||||||Mixed Models Analysis||||
1592384|NCT03087643|2927588|Other|||||||0.0492|||||||Mixed Models Analysis||||
1592385|NCT03086551|2927592|Other||Effect Size - Cohen's d|-1.46|||||2-Sided||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Comparison quantified as effect size using Cohen's d.|
1592386|NCT03086551|2927592|Other||Effect Size - Cohen's d|-0.15|||||2-Sided||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention across the Active and Sham arms when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Comparison quantified as effect size using Cohen's d.|
1592387|NCT03086551|2927593|Other||Effect Size - Cohen's d|1.13|||||2-Sided||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.|
1592388|NCT03086551|2927593|Other||Effect Size - Cohen's d|-0.35|||||2-Sided||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of the first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 150% of resting motor threshold. Estimate of effect size was derived using Cohen's d.|
1592389|NCT03086551|2927593|Other||Effect Size - Cohen's d|-0.85|||||2-Sided||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Sham arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.|
1592390|NCT03086551|2927593|Other||Effect Size - Cohen's d|-0.31|||||2-Sided||||||||Cohen's d was calculated as the amplitude of the motor evoked potential at the post-intervention assessment minus the amplitude of the motor evoked potential at the pre-baseline assessment. The denominator reflected pooled variance.|Comparison of first dorsal interosseous motor evoked potential (MEP) amplitude elicited from the ipsilesional motor cortex pre-baseline to post-intervention for the Active arm when transcranial magnetic stimulator intensity was set to 120% of resting motor threshold. Estimate of effect size was derived using Cohen's d.|
1592391|NCT03086551|2927594|Other||Effect Size - Cohen's d|0.28|||||2-Sided||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 4 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.|
1592392|NCT03086551|2927594|Other||Effect Size - Cohen's d|-0.69|||||2-Sided||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 3 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.|
1592393|NCT03086551|2927594|Other||Effect Size - Cohen's d|-0.04|||||2-Sided||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 2 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.|
1592394|NCT03086551|2927594|Other||Effect Size - Cohen's d|-0.86|||||2-Sided||||||||Cohen's d was calculated as the change from pre- to immediately post-stimulation (within the same session) for the Active arm minus the change from pre- to immediately post-stimulation for the Sham arm. The denominator reflected pooled variance.|The immediate effect of continuous theta burst stimulation over dorsolateral prefrontal cortex prior to practice was assessed by determining the magnitude of the effect of Active stimulation from pre-intervention to immediately post-intervention in Session 1 of the intervention. Cohen's d was used to derive effect size. The Sham stimulation change was used as the control.|
1592395|NCT03086551|2927595|Other||Effect Size - Cohen's d|0.38|||||2-Sided||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the non-stroke affected limb. Cohen's d was calculated as a measure of effect size.|
1592396|NCT03086551|2927595|Other||Effect Size - Cohen's d|0.08|||||2-Sided||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.|
1592397|NCT03086551|2927595|Other||Effect Size - Cohen's d|0.38|||||2-Sided||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the non-stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.|
1592398|NCT03086551|2927595|Other||Effect Size - Cohen's d|-1.84|||||2-Sided||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus the change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.|Comparison across study arm of the magnitude of improvement in aggregate time to complete all elements of the Jebsen-Taylor Hand Function Test for the stroke affected limb. Cohen's d was calculated as a measure of effect size.|
1592399|NCT03086551|2927595|Other||Effect Size - Cohen's d|0.5|||||2-Sided||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Sham arm.|
1592400|NCT03086551|2927595|Other||Effect Size - Cohen's d|-0.08|||||2-Sided||||||||Cohen's d was calculated as aggregate time to complete all elements at the pre-baseline assessment minus the aggregate time it took to complete all elements at the post-intervention assessment. The denominator reflected pooled variance.|The magnitude of transfer of the task specific practice to functional activities of daily live for the stroke affected limb was assessed by calculating the magnitude of change (Cohen's d) in time to complete the activities of the Jebsen-Taylor Hand Function Test from pre-baseline to post-intervention in the Active arm.|
1592401|NCT03086551|2927596|Other|Cohen's d effect size was calculated to compare the magnitude of change in time to complete the movement sequence from pre-baseline to post-intervention across the Active and Sham arms.|Effect Size - Cohen's d|-0.8|||||2-Sided||||||||Cohen's d was calculated as the change from pre- to post-intervention for the Active arm minus change from pre- to post-intervention for the Sham arm. The denominator reflected pooled variance.||
1592402|NCT03086551|2927596|Other||Effect Size - Cohen's d|0.69|||||2-Sided||||||||Cohen's d was calculated as time to complete the sequence at the pre-baseline assessment minus the time it took to complete the sequence at the post-intervention assessment. The denominator reflected pooled variance.|Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Sham arm. Cohen's d was calculated as a measure of effect size.|
1592403|NCT03086551|2927596|Other||Effect Size - Cohen's d|0.2|||||2-Sided||||||||Cohen's d was calculated as time to complete the sequence at the pre-baseline assessment minus the time it took to complete the sequence at the post-intervention assessment. The denominator reflected pooled variance.|Magnitude of change in sequence completion time from pre-baseline to post-intervention for the Active arm. Cohen's d was calculated as a measure of effect size.|
1592404|NCT03086447|2927597|Non-Inferiority|A non-inferiority margin of 0.5 was used. This margin is based on a 10% difference in the distribution between the Test and Control groups.|Odds Ratio (OR)|1.77|||||2-Sided|95.0|0.98|3.22|||||Odds ratio of Test over Control was calculated.|Proportion of eyes with optimal VA assessed at fitting in the Test group was compared to the Control group.|
1592405|NCT03086447|2927598|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Mean Difference (Final Values)|-3.1|Standard Deviation|2.04|||2-Sided|95.0|-7.2|0.9|||||Mean difference was calculated as Test minus Control|Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.|
1592406|NCT03086447|2927599|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Mean Difference (Final Values)|6.8|Standard Deviation|2.39|||2-Sided|95.0|2.1|11.5|||||Mean difference was calculated as Test minus Control|Sample size calculation was performed considering the effect size of 5 (Test minus Control) to achieve a minimum statistical power of 90% at a 5% significance level.|
1592407|NCT03086447|2927600|Other|It was deemed that a total of 135 subjects per each study group is sufficient to demonstrate no statistical difference in the CS incidence rate between the Test and Control groups with a minimum of 80% statistical power using the reference incidence rate of 0.005% with a correlation of 0.3 between eyes within subject.|Odds Ratio (OR)|0.29|||||2-Sided|95.0|0.004|1.437|||||odds ratio calculated as Test over Control|Proportion of eyes with unacceptable corneal staining (CS) throughout all planned and unplanned visits in the Test group was compared to that in the Control group.|
1592408|NCT03086447|2927601|Other|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of absolute rotation with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Least square mean proportion|99.6|||||2-Sided|95.0|97.5|99.9|||||Above 80% of eyes in the Test group had acceptable rotation.|Proportion of eyes with acceptable absolute rotation assessed at 15-minute upon insertion (fitting, visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.|
1592409|NCT03086447|2927602|Other|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of lens stability with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||2-Sided|95.0|96.5|100.0|||||All eyes (100%) in the Test group had acceptable stability at fitting.|Proportion of eyes with acceptable stability assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.|
1592410|NCT03086447|2927603|Other|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of lens fit with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||2-Sided|95.0|96.5|100.0|||||All eyes (100%) in the Test group had acceptable lens fit at fitting (visit 1).|Proportion of eyes with acceptable lens fit assessed at fitting (visit 1) in the Test group was compared to the historical control rate of 80%. Lower 95% confidence limit was compared to 0.8.|
1592411|NCT03086447|2927604|Other|It was deemed that a total of 135 subjects in the Test group is sufficient to demonstrate statistical acceptance of monocular VA better than equal to 20/40 with a minimum of 90% statistical power using the reference incidence rate of 95% with a correlation of 0.8 between eyes.|Proportion|100.0|||||2-Sided|95.0|96.5|100.0|||||All eyes (100%) in the Test group had acceptable VA throughout the study.|Proportion of eyes with overall acceptable VA assessed throughout the study period (up to 4-week) in the Test group was compared to the historical control acceptable rate of 80%. Lower 95% confidence limit was compared to 0.8.|
1592451|NCT03086135|2927715|Superiority||||||<|0.021|||||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.|
1592452|NCT03086135|2927715|Superiority||||||<|0.51|||||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.|
1592412|NCT03086330|2927667|Other||Treatment difference|-3.81|||<|0.0001|2-Sided|95.0|-4.7|-2.93|||ANCOVA|||The responses were analysed using an ANCOVA with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.|
1592413|NCT03086330|2927668|Other||Treatment difference|-1.42|||<|0.0001|2-Sided|95.0|-1.61|-1.24|||ANCOVA|||The responses were analysed using an analysis of covariance (ANCOVA) with treatment, stratification factor and region as fixed factors and baseline value as covariate. Before analysis, missing data were multiple imputed using observed data from participants within the same group defined by randomised treatment, using a regression model including stratification factor and region as categorical effects and data from baseline and all previous visits as covariates.|
1592414|NCT03086265|2927669|Other|||||||0.0336|||||||t-test, 2 sided|||Comparison of postoperative scores.|
1592415|NCT03086265|2927669|Other|||||||0.7221|||||||t-test, 2 sided|||Comparison of preoperative scores.|
1592416|NCT03086265|2927670|Other|||||||0.4324|||||||t-test, 2 sided||||
1592417|NCT03086265|2927671|Other|||||||0.4143|||||||t-test, 2 sided||||
1592418|NCT03086265|2927672|Other|||||||0.6587|||||||t-test, 2 sided||||
1592419|NCT03086265|2927673|Other|||||||0.8112|||||||t-test, 2 sided||||
1592420|NCT03086265|2927674|Other|||||||0.9856|||||||t-test, 2 sided||||
1592421|NCT03086265|2927675|Other|||||||0.8426|||||||t-test, 2 sided||||
1592422|NCT03086265|2927676|Other|||||||0.2827|||||||t-test, 2 sided||||
1592423|NCT03086265|2927677|Other|||||||0.5625|||||||t-test, 2 sided||||
1592424|NCT03086265|2927678|Other|||||||0.6483|||||||t-test, 2 sided||||
1592425|NCT03086265|2927679|Other|||||||0.1927|||||||t-test, 2 sided||||
1592426|NCT03086265|2927680|Other|||||||0.5513|||||||t-test, 2 sided||||
1592427|NCT03086265|2927681|Other|||||||0.3346|||||||t-test, 2 sided||||
1592428|NCT03086265|2927682|Other|||||||0.0058|||||||t-test, 2 sided||||
1592429|NCT03086265|2927684|Other|||||||0.8322|||||||t-test, 2 sided||||
1592430|NCT03086265|2927685|Other|||||||0.6479|||||||t-test, 2 sided||||
1592431|NCT03086265|2927686|Other|||||||0.7549|||||||t-test, 2 sided||||
1592432|NCT03086265|2927687|Other|||||||0.6876|||||||t-test, 2 sided||||
1592433|NCT03086265|2927696|Other|||||||0.7934|||||||t-test, 2 sided||||
1592434|NCT03086213|2927698|Superiority|During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference—if any—as statistically significant at the 5% level||||||0.05|||||||t-test, 2 sided|Degree of freedom is defined as sample size subtraction one.||null hypothesis|
1592435|NCT03086213|2927701|Superiority|During the calculation of sample size,a sample size of 24 patients per group was calculated as being required to ensure 90% power of detecting the difference—if any—as statistically significant at the 5% level|||||<|0.05||||||the p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance.|t-test, 2 sided|degrees of freedom is defined as sample size subtraction one.||null hypothesis|
1592436|NCT03086213|2927702|Non-Inferiority|the definition of non-inferiority analysis is that the new method is no less effective than standard interventions.|Mean Difference (Final Values)|10.0|Standard Deviation|0.025||0.025|2-Sided|95.0|5.0|95.0||whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance|t-test, 2 sided|degrees of freedom|Paravertebral nerve block arm represents the numerator and intercostal block represents the denominator for relative risk|null hypothesis|
1592437|NCT03086135|2927714|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 12 months vs reference device BP110 on softband at visit 1.|
1592438|NCT03086135|2927714|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 6 months vs reference device BP110 on softband at visit 1.|
1592439|NCT03086135|2927714|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 3 months vs reference device BP110 on softband at visit 1.|
1592440|NCT03086135|2927714|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Adaptive Speech Recognition in Noise with Osia at 4 weeks vs reference device BP110 on softband at visit 1.|
1592441|NCT03086135|2927715|Superiority|||||||0.041|||||||Wilcoxon Signed Rank test|||Speech in quiet at 80dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.|
1592442|NCT03086135|2927715|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.|
1592443|NCT03086135|2927715|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 12 months vs reference device BP110 on softband att visit 1.|
1592444|NCT03086135|2927715|Superiority||||||<|0.56|||||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.|
1592445|NCT03086135|2927715|Superiority||||||<|0.021|||||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.|
1592446|NCT03086135|2927715|Superiority||||||<|0.0051|||||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 6 months vs reference device BP110 on softband att visit 1.|
1592447|NCT03086135|2927715|Superiority||||||<|0.16|||||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.|
1592448|NCT03086135|2927715|Superiority||||||<|0.017|||||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.|
1592449|NCT03086135|2927715|Superiority||||||<|0.18|||||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB SPL with Osia at 3 months vs reference device BP110 on softband att visit 1.|
1592450|NCT03086135|2927715|Superiority||||||<|0.29|||||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB SPL with Osia at 4 weeks vs reference device BP110 on softband att visit 1.|
1592453|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.|
1592454|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.|
1592455|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.|
1592456|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.|
1592457|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.|
1592458|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.|
1592459|NCT03086135|2927716|Superiority||||||<|0.001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.|
1592460|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.|
1592461|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.|
1592462|NCT03086135|2927716|Superiority||||||<|0.8|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 12 months vs the reference device BP110 on a softband at visit 1.|
1592463|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.|
1592464|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.|
1592465|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.|
1592466|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.|
1592467|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.|
1592468|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.|
1592469|NCT03086135|2927716|Superiority||||||<|0.11|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.|
1592470|NCT03086135|2927716|Superiority||||||<|0.0003|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.|
1592471|NCT03086135|2927716|Superiority||||||<|0.0007|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.|
1592472|NCT03086135|2927716|Superiority||||||<|0.1|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 6 months vs the reference device BP110 on a softband at visit 1.|
1592473|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.|
1592474|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Hearing performance: threshold audiometry 6000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.|
1592475|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.|
1592476|NCT03086135|2927716|Superiority||||||<|0.0008|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.|
1592477|NCT03086135|2927716|Superiority||||||<|0.0048|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.|
1592478|NCT03086135|2927716|Superiority||||||<|0.34|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.|
1592479|NCT03086135|2927716|Superiority||||||<|0.67|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.|
1592480|NCT03086135|2927716|Superiority||||||<|0.037|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.|
1592481|NCT03086135|2927716|Superiority||||||<|0.04|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.|
1592482|NCT03086135|2927716|Superiority||||||<|0.019|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 3 months vs the reference device BP110 on a softband at visit 1.|
1592483|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 8000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.|
1592484|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 6000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.|
1592485|NCT03086135|2927716|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 4000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.|
1592486|NCT03086135|2927716|Superiority||||||<|0.0046|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 3000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.|
1592487|NCT03086135|2927716|Superiority||||||<|0.019|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 2000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.|
1592488|NCT03086135|2927716|Superiority||||||<|0.73|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.|
1592489|NCT03086135|2927716|Superiority||||||<|0.67|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 1000Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.|
1592490|NCT03086135|2927716|Superiority||||||<|0.015|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 750Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.|
1592491|NCT03086135|2927716|Superiority||||||<|0.096|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 500Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.|
1592492|NCT03086135|2927716|Superiority||||||<|0.025|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry 250Hz with Osia at 4 week vs the reference device BP110 on a softband at visit 1.|
1592493|NCT03086135|2927717|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 12 months vs the reference device BP110 on a softband at visit 1.|
1592494|NCT03086135|2927717|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 6 months vs the reference device BP110 on a softband at visit 1.|
1592495|NCT03086135|2927717|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 3 months vs the reference device BP110 on a softband at visit 1.|
1592496|NCT03086135|2927717|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Hearing performance: threshold audiometry PTA4 with Osia at 4 week vs the reference device BP110 on a softband at visit 1.|
1592497|NCT03086135|2927718|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||SSQ Quality score at 12 months with the Osia system vs Unaided at visit 1.|
1592498|NCT03086135|2927718|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||SSQ Spatial score at 12 months with the Osia system vs Unaided at visit 1.|
1592499|NCT03086135|2927718|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||SSQ Speech score at 12 months with the Osia system vs Unaided at visit 1.|
1592500|NCT03086135|2927718|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||SSQ Total score at 12 months with the Osia system vs Unaided at visit 1.|
1592501|NCT03086135|2927718|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||SSQ Quality score at 3 months with the Osia system vs Unaided at visit 1.|
1592502|NCT03086135|2927718|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||SSQ Spatial score at 3 months with the Osia system vs Unaided at visit 1.|
1592503|NCT03086135|2927718|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||SSQ Speech score at 3 months with the Osia system vs Unaided at visit 1.|
1592504|NCT03086135|2927718|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||SSQ Total score at 3 months with the Osia system vs Unaided at visit 1.|
1592505|NCT03086135|2927719|Superiority|||||||0.56|||||||Fisher's non-parametric permutation test|||HUI Pain attribute, at 12 months with the Osia system vs Unaided at visit 1.|
1592506|NCT03086135|2927719|Superiority|||||||1|||||||Fisher's non-parametric permutation test|||HUI Cognition attribute, at 12 months with the Osia system vs Unaided at visit 1.|
1592507|NCT03086135|2927719|Superiority|||||||0.85|||||||Fisher's non-parametric permutation test|||HUI Emotion attribute, at 12 months with the Osia system vs Unaided at visit 1.|
1592508|NCT03086135|2927719|Superiority|||||||0.16|||||||Fisher's non-parametric permutation test|||HUI Dexterity attribute, at 12 months with the Osia system vs Unaided at visit 1.|
1592509|NCT03086135|2927719|Superiority|||||||0.16|||||||Fisher's non-parametric permutation test|||HUI Ambulation attribute, at 12 months with the Osia system vs Unaided at visit 1.|
1592510|NCT03086135|2927719|Superiority|||||||0.0024|||||||Fisher's non-parametric permutation test|||HUI Speech attribute, at 12 months with the Osia system vs Unaided at visit 1.|
1592511|NCT03086135|2927719|Superiority|||||||0.0026|||||||Fisher's non-parametric permutation test|||HUI Hearing attribute, at 12 months with the Osia system vs Unaided at visit 1.|
1592512|NCT03086135|2927719|Superiority|||||||0.23|||||||Wilcoxon Signed Rank test|||HUI Vision attribute, at 12 months with the Osia system vs Unaided at visit 1.|
1592513|NCT03086135|2927719|Superiority|||||||0.13|||||||Fisher's non-parametric permutation test|||HUI Comprehensive Health State attribute, at 12 months with the Osia system vs Unaided at visit 1.|
1592514|NCT03086135|2927719|Superiority|||||||0.72|||||||Wilcoxon Signed Rank test|||HUI Pain attribute, at 3 months with the Osia system vs Unaided at visit 1.|
1592515|NCT03086135|2927719|Superiority|||||||0.31|||||||Fisher's non-parametric permutation test|||HUI Cognition attribute, at 3 months with the Osia system vs Unaided at visit 1.|
1592516|NCT03086135|2927719|Superiority|||||||0.43|||||||Fisher's non-parametric permutation test|||HUI Emotion attribute, at 3 months with the Osia system vs Unaided at visit 1.|
1592517|NCT03086135|2927719|Superiority|||||||0.9|||||||Wilcoxon Signed Rank test|||HUI Dexterity attribute, at 3 months with the Osia system vs Unaided at visit 1.|
1592518|NCT03086135|2927719|Superiority|||||||0.13|||||||Fisher's non-parametric permutation test|||HUI Ambulation attribute, at 3 months with the Osia system vs Unaided at visit 1.|
1593407|NCT03039621|2929585|Superiority|||||||0.0025|||||||Cochran-Mantel-Haenszel||||
1592519|NCT03086135|2927719|Superiority|||||||0.082|||||||Fisher's non-parametric permutation test|||HUI Speech attribute, at 3 months with the Osia system vs Unaided at visit 1.|
1592520|NCT03086135|2927719|Superiority|||||||0.0008|||||||Fisher's non-parametric permutation test|||HUI Hearing attribute, at 3 months with the Osia system vs Unaided at visit 1.|
1592521|NCT03086135|2927719|Superiority|||||||0.5|||||||Fisher's non-parametric permutation test|||HUI Vision attribute at 3 months with the Osia system vs Unaided at visit 1.|
1592522|NCT03086135|2927719|Superiority|||||||0.026|||||||Fisher's non-parametric permutation test|||HUI Comprehensive health state at 3 months with the Osia system vs Unaided at visit 1.|
1592523|NCT03086135|2927720|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||APHAB, Global score, at 12 months with the Osia system vs Unaided at visit 1.|
1592524|NCT03086135|2927720|Superiority||||||<|0.32|||||||Fisher's non-parametric permutation test|||APHAB, Aversiveness, at 12 months with the Osia system vs Unaided at visit 1.|
1592525|NCT03086135|2927720|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||APHAB, Reverberation, at 12 months with the Osia system vs Unaided at visit 1.|
1592526|NCT03086135|2927720|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||APHAB, Background noise, at 12 months with the Osia system vs Unaided at visit 1.|
1592527|NCT03086135|2927720|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||APHAB, Ease of communication, at 12 months with the Osia system vs Unaided at visit 1.|
1592528|NCT03086135|2927720|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||APHAB, Global score, at 3 months with the Osia system vs Unaided at visit 1.|
1592529|NCT03086135|2927720|Superiority||||||<|0.51|||||||Fisher's non-parametric permutation test|||APHAB, Aversiveness, at 3 months with the Osia system vs Unaided at visit 1.|
1592530|NCT03086135|2927720|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||APHAB, Reverberation, at 3 months with the Osia system vs Unaided at visit 1.|
1592531|NCT03086135|2927720|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||APHAB, Background noise, at 3 months with the Osia system vs Unaided at visit 1.|
1592532|NCT03086135|2927720|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||APHAB, Ease of communication, at 3 months with the Osia system vs Unaided at visit 1.|
1592533|NCT03086135|2927721|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 12 months with the Osia system vs Unaided at visit 1.|
1592534|NCT03086135|2927721|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 6 months with the Osia system vs Unaided at visit 1.|
1592535|NCT03086135|2927721|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Adaptive speech recognition in noise at 4 weeks with the Osia system vs Unaided at visit 1.|
1592536|NCT03086135|2927722|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 12 months with the Osia system vs Unaided at visit 1.|
1592537|NCT03086135|2927722|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Speech in quiet at 65dB at 12 months with the Osia system vs Unaided at visit 1.|
1592538|NCT03086135|2927722|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 12 months with the Osia system vs Unaided at visit 1.|
1592539|NCT03086135|2927722|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 6 months with the Osia system vs Unaided at visit 1.|
1592540|NCT03086135|2927722|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 6 months with the Osia system vs Unaided at visit 1.|
1592541|NCT03086135|2927722|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 6 months with the Osia system vs Unaided at visit 1.|
1592542|NCT03086135|2927722|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 3 months with the Osia system vs Unaided at visit 1.|
1592543|NCT03086135|2927722|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 3 months with the Osia system vs Unaided at visit 1.|
1592544|NCT03086135|2927722|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 3 months with the Osia system vs Unaided at visit 1.|
1592545|NCT03086135|2927722|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in quiet at 80dB at 4 weeks with the Osia system vs Unaided at visit 1.|
1592546|NCT03086135|2927722|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in quiet at 65dB at 4 weeks with the Osia system vs Unaided at visit 1.|
1592547|NCT03086135|2927722|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in quiet at 50dB at 4 weeks with the Osia system vs Unaided at visit 1.|
1592548|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 12 months with the Osia system vs Unaided at visit 1.|
1592549|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 12 months with the Osia system vs Unaided at visit 1.|
1592550|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 12 months with the Osia system vs Unaided at visit 1.|
1592551|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 12 months with the Osia system vs Unaided at visit 1.|
1592552|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 12 months with the Osia system vs Unaided at visit 1.|
1592553|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 12 months with the Osia system vs Unaided at visit 1.|
1592554|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 12 months with the Osia system vs Unaided at visit 1.|
1592555|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 12 months with the Osia system vs Unaided at visit 1.|
1592620|NCT03078556|2927842|Other||Ratio|1.0442|||||2-Sided|90.0|0.9951|1.0957|||||Ratio (Bfed/B) of plasma 3TC has been presented||
1592556|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 12 months with the Osia system vs Unaided at visit 1.|
1592557|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 12 months with the Osia system vs Unaided at visit 1.|
1592558|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 6 months with the Osia system vs Unaided at visit 1.|
1592559|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 6 months with the Osia system vs Unaided at visit 1.|
1592560|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 6 months with the Osia system vs Unaided at visit 1.|
1592561|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 6 months with the Osia system vs Unaided at visit 1.|
1592562|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 6 months with the Osia system vs Unaided at visit 1.|
1592563|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 6 months with the Osia system vs Unaided at visit 1.|
1592564|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 6 months with the Osia system vs Unaided at visit 1.|
1592565|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 6 months with the Osia system vs Unaided at visit 1.|
1592566|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 6 months with the Osia system vs Unaided at visit 1.|
1592567|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 6 months with the Osia system vs Unaided at visit 1.|
1592568|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 3 months with the Osia system vs Unaided at visit 1.|
1592569|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 3 months with the Osia system vs Unaided at visit 1.|
1592570|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 3 months with the Osia system vs Unaided at visit 1.|
1592571|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 3 months with the Osia system vs Unaided at visit 1.|
1592572|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 3 months with the Osia system vs Unaided at visit 1.|
1592573|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 3 months with the Osia system vs Unaided at visit 1.|
1592574|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 3 months with the Osia system vs Unaided at visit 1.|
1592575|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 3 months with the Osia system vs Unaided at visit 1.|
1592576|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 3 months with the Osia system vs Unaided at visit 1.|
1592577|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 250Hz at 3 months with the Osia system vs Unaided at visit 1.|
1592578|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 8000Hz at 4 weeks with the Osia system vs Unaided at visit 1.|
1592579|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 6000Hz at 4 weeks with the Osia system vs Unaided at visit 1.|
1592580|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 4000Hz at 4 weeks with the Osia system vs Unaided at visit 1.|
1592581|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 3000Hz at 4 weeks with the Osia system vs Unaided at visit 1.|
1592582|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 2000Hz at 4 weeks with the Osia system vs Unaided at visit 1.|
1592583|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 1500Hz at 4 weeks with the Osia system vs Unaided at visit 1.|
1592584|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 1000Hz at 4 weeks with the Osia system vs Unaided at visit 1.|
1592585|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 750Hz at 4 weeks with the Osia system vs Unaided at visit 1.|
1592586|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry at 500Hz at 4 weeks with the Osia system vs Unaided at visit 1.|
1592587|NCT03086135|2927723|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Threshold audiometry 250Hz at 4 weeks with the Osia system vs Unaided at visit 1.|
1592588|NCT03086135|2927724|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 at 12 months with the Osia system vs Unaided at visit 1.|
1592589|NCT03086135|2927724|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 at 6 months with the Osia system vs Unaided at visit 1.|
1592590|NCT03086135|2927724|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 at 4 weeks with the Osia system vs Unaided at visit 1.|
1592591|NCT03086135|2927725|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||Speech in noise at 3 months with the Osia system vs Unaided at visit 1|
1592592|NCT03086135|2927726|Superiority||||||<|0.0001|||||||Fisher's non-parametric permutation test|||PTA4 at 3 months with the Osia system vs Unaided at visit 1|
1593408|NCT03039621|2929586|Superiority|||||||0.046|||||||Wilcoxon (Mann-Whitney)||||
1592593|NCT03085238|2927759|Non-Inferiority|The primary safety endpoint will be analyzed using a unilateral one sample test for binomial proportion at the 5% level.||||||0.0181|||||||unilateral one sample test for binomial|||H0: M-Trap freedom MAE incidence <= 90% - Non-inferiority margin (25%)|
1592594|NCT03085238|2927760|Non-Inferiority|The primary safety endpoint will be analyzed using a unilateral one sample test for binomial proportion at the 5% level.||||||0.1309|||||||unilateral one sample test for binomial|||H0: M-Trap freedom MAE incidence <= 90% - Non-inferiority margin (25%)|
1592595|NCT03083639|2927766|Equivalence|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of Cmax using ANOVA models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90% CIs for the ratio of Cmax central values between esomeprazole capsules and tablets are presented.|Point estimate|0.942|||||2-Sided|90.0|0.88|1.009|||||||
1592596|NCT03083639|2927767|Equivalence|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of AUCt using ANOVA models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90% CIs for the ratio of AUC central values between esomeprazole capsules and tablets are presented.|Point estimate|0.993|||||2-Sided|90.0|0.939|1.05|||||||
1592597|NCT03083639|2927768|Equivalence|The bioequivalence between esomeprazole capsules (Regimen A) and esomeprazole tablets (Regimen B) was assessed for the natural logarithms of AUC∞ using analysis of variance (ANOVA) models. The models included regimen, period, and sequence as fixed effects and participant nested within sequence as a random effect. Within ANOVA framework, point estimates and their 90 percent (%) confidence intervals (CIs) for the ratio of AUC central values between esomeprazole capsules and tablets are presented.|Point estimate|1.018|||||2-Sided|90.0|0.969|1.07|||||||
1592598|NCT03083379|2927778|Equivalence|Equivalency is defined as no statistically significant difference in dorsal region redistribution of ventilation following breath cycle 1, 2, and 3 lung expansion therapy sequences.||||||0.9|||||||Mann-Whitney U test||||
1592599|NCT03080961|2927791|Superiority|||||||0.013|||||||Wilcoxon (Mann-Whitney)||||
1592600|NCT03080961|2927792|Superiority|||||||0.248|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis will evaluate the difference in detection rate between pre and post-VIBLOK swabs. For each person the number of swabs with shedding only pre-VIBLOK will be assessed, and then the number of swabs with shedding only post-VIBLOK will be subtracted. A number above 0 indicates a decreased detection rate after VIBLOK. With an 8% anticipated asymptomatic shedding rate, 80% power, 50 subjects taking samples for 28 days are needed to show a 50% reduction.|
1592601|NCT03080961|2927793|Other||SADE percentage|0.0|||||2-Sided|95.0|0.0|7.7||||||SADE rate after minimally 26 days of VIBLOK treatment will be assessed by calculating the upper limit of the 2-sided exact 95% Clopper-Pearson confidence interval which needs to be below 10%. With a sample size of 36, an exact two-sided 95.0% confidence interval for a single proportion would show that the SADE incidence is below 10% at an expected incidence of 0.1%.|
1592602|NCT03080454|2927800|Equivalence|Statistical analysis for mean Tardieu Scale Score summed across 11 joints of the upper extremity in 2 conditions (anodal vs. sham Doublestim) and at 2 timepoints (final session at day 5 and 1 week FU). Null hypothesis is that there was no difference in mean change between anodal and sham Doubleestim conditions. A significance level of 0.05 was used (two-sided).||||||0.003||||||A 2x2 repeated measures ANOVA was performed with condition (mean score in anodal vs. sham condition) and time (final session at day 5 and 1 week FU in each condition) as factors. A significance level of 0.05 was used (two-sided).|ANOVA||||
1592603|NCT03080454|2927801|Equivalence|Statistical analysis for mean percent change from baseline in area under the curve for the resistance torque measure across 2 conditions (anodal vs. sham Doublestim) and at 2 timepoints (final session at day 5 and 1 week FU). Null hypothesis is that there was no difference in mean percent change in area under the curve between anodal and sham Doublestim conditions. A significance level of 0.05 was used (two-sided).||||||0.004||||||A 2x2 repeated measures ANOVA was performed with condition (mean percent change in anodal vs. sham condition) and time (final session at day 5 and 1 week FU in each condition) as factors. A significance level of 0.05 was used (two-sided).|ANOVA||||
1592604|NCT03079531|2927802|Other|||||||0.56|||||||Wilcoxon signed rank test||||
1592605|NCT03079531|2927804|Other||||||<|0.001|||||||Wilcoxon signed rank test||||
1592606|NCT03079531|2927805|Other|||||||0.2|||||||Wilcoxon signed rank test||||
1592607|NCT03079531|2927806|Other|||||||0.03|||||||Wilcoxon signed rank test||||
1592608|NCT03079531|2927807|Other|||||||0.02|||||||Wilcoxon signed rank test||||
1592609|NCT03079531|2927808|Other|||||||0.01|||||||Wilcoxon signed rank test|||The null hypothesis is that there would be no difference in papule/pustule count at baseline and after 16 weeks of secukinumab; the alternative hypothesis is that there would be a difference. Using an alpha=0.05 and power=0.80 (two sided test), the sample size needed would be 20. Assuming a dropout rate of 20%, 24 patients would be needed to achieve sufficient sample size.|
1592610|NCT03078556|2927835|Other||Ratio|1.1935|||||2-Sided|90.0|1.1142|1.2785|||||Ratio (Cfed/C) of plasma 3TC has been presented||
1592611|NCT03078556|2927835|Other||Ratio|1.469|||||2-Sided|90.0|1.3009|1.6588|||||Ratio (Cfed/C) of plasma DTG has been presented||
1592612|NCT03078556|2927836|Other||Ratio|1.2015|||||2-Sided|90.0|1.1074|1.3036|||||Ratio (Bfed/B) of plasma 3TC has been presented||
1592613|NCT03078556|2927836|Other||Ratio|1.2929|||||2-Sided|90.0|1.1281|1.4819|||||Ratio (Bfed/B) of plasma DTG has been presented||
1592614|NCT03078556|2927837|Other||Ratio|1.197|||||2-Sided|90.0|1.0869|1.3182|||||Ratio (Cfed/C) of plasma 3TC has been presented||
1592615|NCT03078556|2927837|Other||Ratio|0.7657|||||2-Sided|90.0|0.6702|0.8749|||||Ratio (Cfed/C) of plasma DTG has been presented||
1592616|NCT03078556|2927838|Other||Ratio|1.0841|||||2-Sided|90.0|0.9139|1.286|||||Ratio (Bfed/B) of plasma 3TC has been presented||
1592617|NCT03078556|2927838|Other||Ratio|0.8654|||||2-Sided|90.0|0.7629|0.9816|||||Ratio (Bfed/B) of plasma DTG has been presented||
1592618|NCT03078556|2927841|Other||Ratio|1.0972|||||2-Sided|90.0|1.0424|1.155|||||Ratio (Cfed/C) of plasma 3TC has been presented||
1592619|NCT03078556|2927841|Other||Ratio|0.7544|||||2-Sided|90.0|0.6736|0.8448|||||Ratio (Cfed/C) of plasma DTG has been presented||
1599065|NCT02858401|2938159|Other|||||||1|||||||Fisher Exact||||
1592621|NCT03078556|2927842|Other||Ratio|0.8661|||||2-Sided|90.0|0.7658|0.9796|||||Ratio (Bfed/B) of plasma DTG has been presented||
1592622|NCT03078556|2927843|Other||Median Difference (Final Values)|0.8836|||||2-Sided|90.0|0.8351|0.935|||||Median Difference of plasma 3TC has been presented||
1592623|NCT03078556|2927843|Other||Median Difference (Final Values)|1.2477|||||2-Sided|90.0|1.1013|1.4136|||||Median Difference of plasma DTG has been presented||
1592624|NCT03078556|2927844|Other||Ratio|0.9363|||||2-Sided|90.0|0.8913|0.9836|||||Ratio (Bfed/B) of plasma 3TC has been presented||
1592625|NCT03078556|2927844|Other||Ratio|1.0849|||||2-Sided|90.0|0.9613|1.2245|||||Ratio (Bfed/B) of plasma DTG has been presented||
1592626|NCT03078556|2927853|Other||Median Difference (Final Values)|1.503|||||2-Sided|90.0|0.998|2.252|||||Median Difference of plasma 3TC has been presented||
1592627|NCT03078556|2927853|Other||Median Difference (Final Values)|2.5|||||2-Sided|90.0|1.748|3.751|||||Median Difference of plasma DTG has been presented||
1592628|NCT03078556|2927854|Other||Median Difference (Final Values)|2.113|||||2-Sided|90.0|1.5|2.751|||||Median Difference of plasma 3TC has been presented||
1592629|NCT03078556|2927854|Other||Median Difference (Final Values)|3.017|||||2-Sided|90.0|1.872|4.496|||||Median Difference of plasma DTG has been presented||
1592630|NCT03078556|2927855|Other||Median Difference (Final Values)|0.0|||||2-Sided|90.0|0.0|0.125|||||Median Difference of plasma 3TC has been presented||
1592631|NCT03078556|2927855|Other||Median Difference (Final Values)|0.126|||||2-Sided|90.0|0.0|0.25|||||Median Difference of plasma DTG has been presented||
1592632|NCT03078556|2927856|Other||Median Difference (Final Values)|0.125|||||2-Sided|90.0|0.0|0.127|||||Median Difference of plasma 3TC has been presented||
1592633|NCT03078556|2927856|Other||Median Difference (Final Values)|0.254|||||2-Sided|90.0|0.25|0.378|||||Median Difference of plasma DTG has been presented||
1592634|NCT03078556|2927857|Other||Ratio|0.6826|||||2-Sided|90.0|0.5861|0.795|||||Ratio (Cfed/C) of plasma 3TC has been presented||
1592635|NCT03078556|2927857|Other||Ratio|1.2096|||||2-Sided|90.0|1.0521|1.3908|||||Ratio (Cfed/C) of plasma DTG has been presented||
1592636|NCT03078556|2927858|Other||Ratio|0.7097|||||2-Sided|90.0|0.6474|0.7779|||||Ratio (Bfed/B) of plasma 3TC has been presented||
1592637|NCT03078556|2927858|Other||Ratio|1.0808|||||2-Sided|90.0|0.9527|1.2261|||||Ratio (Bfed/B) of plasma DTG has been presented||
1592638|NCT03078556|2927859|Other||Ratio|0.9048|||||2-Sided|90.0|0.8592|0.9528|||||Ratio (Cfed/C) of plasma 3TC has been presented||
1592639|NCT03078556|2927859|Other||Ratio|1.3176|||||2-Sided|90.0|1.175|1.4775|||||Ratio (Cfed/C) of plasma DTG has been presented||
1592640|NCT03078556|2927860|Other||Ratio|0.9524|||||2-Sided|90.0|0.9086|0.9983|||||Ratio (Bfed/B) of plasma 3TC has been presented||
1592641|NCT03078556|2927860|Other||Ratio|1.1481|||||2-Sided|90.0|1.0154|1.2982|||||Ratio (Bfed/B) of plasma DTG has been presented||
1592642|NCT03078556|2927861|Other||Ratio|0.9114|||||2-Sided|90.0|0.8658|0.9593|||||Ratio (Cfed/C) of plasma 3TC has been presented||
1592643|NCT03078556|2927861|Other||Ratio|1.3256|||||2-Sided|90.0|1.1837|1.4845|||||Ratio (Cfed/C) of plasma DTG has been presented||
1592644|NCT03078556|2927862|Other||Ratio|0.9577|||||2-Sided|90.0|0.9126|1.0049|||||Ratio (Bfed/B) of plasma 3TC has been presented||
1592645|NCT03078556|2927862|Other||Ratio|1.1545|||||2-Sided|90.0|1.0208|1.3058|||||Ratio (Bfed/B) of plasma DTG has been presented||
1592646|NCT03078556|2927863|Other||Ratio|0.9049|||||2-Sided|90.0|0.8474|0.9663|||||Ratio (B/A) of plasma 3TC has been presented||
1592647|NCT03078556|2927863|Other||Ratio|1.078|||||2-Sided|90.0|0.9958|1.167|||||Ratio (B/A) of plasma DTG has been presented||
1592648|NCT03078556|2927864|Other||Ratio|0.8874|||||2-Sided|90.0|0.834|0.9443|||||Ratio (B/A) of plasma 3TC has been presented||
1592649|NCT03078556|2927864|Other||Ratio|1.1839|||||2-Sided|90.0|1.0921|1.2834|||||Ratio (B/A) of plasma DTG has been presented||
1592650|NCT03078556|2927865|Other||Ratio|0.9548|||||2-Sided|90.0|0.9299|0.9804|||||Ratio (C/A) of plasma 3TC has been presented.||
1592651|NCT03078556|2927865|Other||Ratio|1.1425|||||2-Sided|90.0|1.0597|1.2317|||||Ratio (C/A) of plasma DTG has been presented.||
1592652|NCT03078556|2927866|Other||Ratio|0.9598|||||2-Sided|90.0|0.9268|0.9941|||||Ratio (B/A) of plasma 3TC has been presented.||
1592653|NCT03078556|2927866|Other||Ratio|1.2632|||||2-Sided|90.0|1.1811|1.3511|||||Ratio (B/A) of plasma DTG has been presented.||
1592654|NCT03078556|2927867|Other||Ratio|0.9153|||||2-Sided|90.0|0.8613|0.9728|||||Ratio (C/A) of plasma 3TC has been presented.||
1592655|NCT03078556|2927867|Other||Ratio|0.8571|||||2-Sided|90.0|0.7914|0.9282|||||Ratio (C/A) of plasma DTG has been presented.||
1592656|NCT03078556|2927868|Other||Ratio|0.9704|||||2-Sided|90.0|0.9157|1.0284|||||Ratio (B/A) of plasma 3TC has been presented.||
1592657|NCT03078556|2927868|Other||Ratio|0.7859|||||2-Sided|90.0|0.7318|0.844|||||Ratio (B/A) of plasma DTG has been presented.||
1592658|NCT03078556|2927869|Other||Ratio|0.9403|||||2-Sided|90.0|0.9207|0.9604|||||Ratio (C/A) of plasma 3TC has been presented.||
1592659|NCT03078556|2927869|Other||Ratio|0.8658|||||2-Sided|90.0|0.8021|0.9347|||||Ratio (C/A) of plasma DTG has been presented.||
1592660|NCT03078556|2927870|Other||Ratio|0.967|||||2-Sided|90.0|0.9442|0.9904|||||Ratio (B/A) of plasma 3TC has been presented.||
1592661|NCT03078556|2927870|Other||Ratio|0.7868|||||2-Sided|90.0|0.7363|0.8408|||||Ratio (B/A) of plasma DTG has been presented.||
1592662|NCT03078556|2927871|Other||Ratio|1.0807|||||2-Sided|90.0|1.0539|1.1081|||||Ratio (C/A) of plasma 3TC has been presented.||
1592663|NCT03078556|2927871|Other||Ratio|1.1599|||||2-Sided|90.0|1.0711|1.256|||||Ratio (C/A) of plasma DTG has been presented.||
1592664|NCT03078556|2927872|Other||Ratio|1.0475|||||2-Sided|90.0|1.0185|1.0773|||||Ratio (B/A) of plasma 3TC has been presented.||
1592665|NCT03078556|2927872|Other||Ratio|1.2774|||||2-Sided|90.0|1.1931|1.3676|||||Ratio (B/A) of plasma DTG has been presented.||
1592666|NCT03078556|2927881|Other||Median Difference (Final Values)|-0.248|||||2-Sided|90.0|-0.376|-0.001|||||Median Difference of plasma 3TC has been presented.||
1592667|NCT03078556|2927881|Other||Median Difference (Final Values)|-0.127|||||2-Sided|90.0|-0.497|0.132|||||Median Difference of plasma DTG has been presented.||
1592668|NCT03078556|2927882|Other||Median Difference (Final Values)|-0.126|||||2-Sided|90.0|-0.253|-0.001|||||Median Difference of plasma 3TC has been presented.||
1592669|NCT03078556|2927882|Other||Median Difference (Final Values)|-0.127|||||2-Sided|90.0|-0.5|0.248|||||Median Difference of plasma DTG has been presented.||
1592670|NCT03078556|2927883|Other||Median Difference (Final Values)|0.0|||||2-Sided|90.0|0.0|0.0|||||Median Difference of plasma 3TC has been presented.||
1592671|NCT03078556|2927883|Other||Median Difference (Final Values)|0.0|||||2-Sided|90.0|-0.004|0.0|||||Median Difference of plasma DTG has been presented.||
1592672|NCT03078556|2927884|Other||Median Difference (Final Values)|0.0|||||2-Sided|90.0|0.0|0.0|||||Median Difference of plasma 3TC has been presented.||
1592673|NCT03078556|2927884|Other||Median Difference (Final Values)|0.0|||||2-Sided|90.0|0.0|0.0|||||Median Difference of plasma DTG has been presented.||
1592674|NCT03078556|2927885|Other||Ratio|1.3176|||||2-Sided|90.0|1.2616|1.376|||||Ratio (C/A) of plasma 3TC has been presented.||
1592675|NCT03078556|2927885|Other||Ratio|1.141|||||2-Sided|90.0|1.0533|1.2361|||||Ratio (C/A) of plasma DTG has been presented.||
1592676|NCT03078556|2927886|Other||Ratio|1.1956|||||2-Sided|90.0|1.1437|1.2498|||||Ratio (B/A) of plasma 3TC has been presented.||
1592677|NCT03078556|2927886|Other||Ratio|1.2805|||||2-Sided|90.0|1.189|1.379|||||Ratio (B/A) of plasma DTG has been presented.||
1592678|NCT03078556|2927887|Other||Ratio|1.0702|||||2-Sided|90.0|1.0464|1.0946|||||Ratio (C/A) of plasma 3TC has been presented.||
1592679|NCT03078556|2927887|Other||Ratio|1.1578|||||2-Sided|90.0|1.0718|1.2507|||||Ratio (C/A) of plasma DTG has been presented.||
1592680|NCT03078556|2927888|Other||Ratio|1.0372|||||2-Sided|90.0|1.0116|1.0634|||||Ratio (B/A) of plasma 3TC has been presented.||
1592681|NCT03078556|2927888|Other||Ratio|1.2756|||||2-Sided|90.0|1.1919|1.3651|||||Ratio (B/A) of plasma DTG has been presented.||
1592682|NCT03078556|2927889|Other||Ratio|1.0635|||||2-Sided|90.0|1.0413|1.0861|||||Ratio (C/A) of plasma 3TC has been presented.||
1592683|NCT03078556|2927889|Other||Ratio|1.155|||||2-Sided|90.0|1.0699|1.2468|||||Ratio (C/A) of plasma DTG has been presented.||
1592684|NCT03078556|2927890|Other||Ratio|1.0341|||||2-Sided|90.0|1.0097|1.0591|||||Ratio (B/A) of plasma 3TC has been presented.||
1592685|NCT03078556|2927890|Other||Ratio|1.271|||||2-Sided|90.0|1.1894|1.3582|||||Ratio (B/A) of plasma DTG has been presented.||
1592686|NCT03078478|2927907|Superiority||Treatment rate ratio|0.88||||0.1715|2-Sided|95.0|0.73|1.06|||Regression, Cox|||The number of episodes is analysed using a negative binomial regression model (log link) with the logarithm of the time period in which a hypoglycaemic episode was considered treatment emergent as offset. The model includes treatment, number of OADs, region, sex and dosing time as fixed factors, and age as a covariate. Missing values are imputed through multiple imputation by treatment arm, based on a Poisson model.|
1592687|NCT03078127|2927909|Superiority|||||||0.07||||||Non-parametric test used due to lack of data normality. The a priori threshold for statistical significance was < 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.|
1592688|NCT03078127|2927910|Other|A linear regression was performed between change in pre and post-ACT adenosine (purine) in EBC and Ave90Clr||||||0.047||||||The a priori threshold of statistical significance was p = 0.05|Regression, Linear|||If the difference between pre and post-ACT adenosine (purine) in EBC was significant (defined as p<0.05), the correlation between change in adenosine concentration and MCC (as represented by Ave90Clr) was investigated.|
1592689|NCT03078127|2927910|Superiority|||||||0.041||||||Non-parametric test used due to lack of data normality. The a priori threshold for statistical significance was < 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.|
1592690|NCT03078127|2927911|Superiority|||||||0.146||||||Non-parametric test used due to lack of data normality. The a prior threshold for statistical significance was < 0.05|Wilcoxon signed-rank test|||The study was not designed or powered to assess for inter-group differences between the types of ACT, and for analytical purposes, these were pooled, with the analysis being a paired comparison within subjects to pre- to post-ACT.|
1592691|NCT03078127|2927912|Other|A linear regression was performed between change in FENO and Ave90Clr||||||0.692||||||The a priori threshold for statistical significance (i.e., slope different than zero) between MCC and FENO was 0.05|Regression, Linear|||if the difference between pre and post-ACT FENO was significant (defined as p<0.05), it was investigated whether change in FENO correlated with MCC (as represented by Ave90Clr)|
1592692|NCT03078127|2927912|Superiority|||||||0.001||||||The a priori threshold of statistical significance was p = 0.05|t-test, 2 sided|||The investigators compared FENO before and after ACT in a pooled manner (i.e., grouping each of the comparisons together), as the study was not powered for FENO comparisons within each ACT type.|
1592693|NCT03078127|2927914|Superiority|||||||0.696||||||ANOVA was performed (with multiple comparisons to compare each intervention to baseline) to assess for difference in MCC with each ACT. The a priori threshold for significance was < 0.05.|ANOVA||||
1592694|NCT03078127|2927915|Superiority|||||||0.615||||||ANOVA was performed (with multiple comparisons to compare each intervention to baseline) to assess for difference in MCC with each ACT. The a priori threshold for statistical significance was set to 0.05|ANOVA|||No comparable preliminary data exists on mucociliary clearance (MCC) in response to airway clearance therapy methods (ACTs) for a power calculation. However, prior studies of medication effect on MCC gave a baseline mean change of Ave270 clr of 27.7% (std dev of 15.1%). Thus, the investigators estimated a mean change of 20% for effective ACT with the same estimate for variability (Std Dev of 15.1%). Using a paired 2-tailed test to compare means, 7 subjects were estimated to be needed.|
1592695|NCT03077607|2927969|Equivalence|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|102.04|||||2-Sided|90.0|94.02|110.74||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.|
1592696|NCT03077607|2927970|Equivalence|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|105.37|||||2-Sided|90.0|98.04|113.24||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in Combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.|
1599066|NCT02858401|2938159|Other|||||||1|||||||Fisher Exact||||
1592697|NCT03077607|2927971|Equivalence|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|136.62|||||2-Sided|90.0|103.2|180.87||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with rifampin and reference is talazoparib alone. Statistical data was calculated by using ANOVA.|
1592698|NCT03077607|2927972|Equivalence|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|156.24|||||2-Sided|90.0|137.58|177.42||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.|
1592699|NCT03077607|2927973|Equivalence|Sample size of 15 participants was selected based on the estimated within participant %CV of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|150.71|||||2-Sided|90.0|136.47|166.43||||||CI: 90% CI on geometric LS mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using ANOVA.|
1592700|NCT03077607|2927974|Equivalence|Sample size of 15 participants was selected based on the estimated within participant % coefficient of variation (CV) of 42% and precision/half width of 90% CI for Test Reference comparison on log scale of 0.259.|Geometric LS Mean Ratio|139.92|||||2-Sided|90.0|113.26|172.87||||||Confidence interval (CI): 90 percent (%) CI on geometric least squares (LS) mean ratio (Test/Reference), test is talazoparib in combination with itraconazole and reference is talazoparib alone. Statistical data was calculated by using analysis of variance (ANOVA)|
1592701|NCT03075891|2928011|Superiority|||||||0.032|||||||Cochran-Mantel-Haenszel||||
1592702|NCT03075410|2928039|Other||Slope|1.06|||||2-Sided|90.0|0.89|1.22|||||Day 14. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.||
1592703|NCT03075410|2928039|Other||Slope|1.19|||||2-Sided|90.0|0.92|1.46|||||Day 1. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.||
1592704|NCT03075410|2928040|Other||Slope|1.06|||||2-Sided|90.0|0.9|1.22|||||Day 14. Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.||
1592705|NCT03075410|2928040|Other||Slope|1.24|||||2-Sided|90.0|1.15|1.33|||||Day 1.Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect.||
1592706|NCT03075410|2928041|Other||Slope|0.96|||||2-Sided|90.0|0.81|1.11|||||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.||
1592707|NCT03075410|2928042|Other||Slope|1.32|||||2-Sided|90.0|1.24|1.39|||||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.||
1592708|NCT03075410|2928043|Other||Slope|0.96|||||2-Sided|90.0|0.82|1.1|||||A slope of 1 indicates the pharmacokinetics are dose proportional. A slope greater than 1 indicates the increase in PK is greater than proportional to dose.||Power Model has been used to assess Dose Proportionality. Log-e(dose) is fitted as Fixed Effect and Participant is fitted as Random Effect. An Unstructured covariance structure is used.
1592709|NCT03075410|2928044|Other||Slope|1.08|||||2-Sided|90.0|1.07|1.08|||||Mixed Effect Model has been used to assess Steady State. Day is fitted as a Fixed Effect. Participant is fitted as Random Effect Variance Components covariance structure is used.|Repeat GSK3036656 15mg Day 1-14|
1592710|NCT03075410|2928044|Other||Slope|1.1|||||2-Sided|90.0|1.09|1.1|||||Mixed Effect Model has been used to assess Steady State. Day is fitted as a Fixed Effect. Participant is fitted as Random Effect Variance Components covariance structure is used.|Repeat GSK3036656 5mg Day 1-14|
1592711|NCT03075410|2928048|Other||Median Difference (Final Values)|0.75|||||2-Sided|90.0|-0.5|2.5|||||Hodges-Lehmann estimation is used to calculate the 90% confidence interval.||
1592712|NCT03075410|2928049|Other||Ratio|0.89|||||2-Sided|90.0|0.64|1.23|||||Fixed Effect Model has been used to assess Food Effect for the log transformed parameter t1/2 Treatment in the fed/fasted state is fitted as Fixed Effect.||
1592713|NCT03075410|2928050|Other||Ratio|0.97|||||2-Sided|90.0|0.76|1.23|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter Cmax. Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is used.||
1592714|NCT03075410|2928051|Other||Ratio|0.94|||||2-Sided|90.0|0.71|1.26|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-inf). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is use||
1592715|NCT03075410|2928052|Other||Ratio|1.07|||||2-Sided|90.0|0.87|1.34|||||Mixed Effect Model has been used to assess Food Effect for the log transformed parameter AUC(0-t). Treatment in the fed/fasted state is fitted as Fixed Effect. Participant is fitted as Random Effect. Variance Components covariance structure is used.||
1592716|NCT03074500|2928088|Superiority|||||||0.734|||||||Kruskal-Wallis|||Immediate effect compared to baseline|
1592717|NCT03074500|2928088|Superiority|||||||0.017|||||||Kruskal-Wallis|||Immediate effect compared to baseline|
1592718|NCT03074500|2928088|Superiority|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups|
1592719|NCT03074500|2928088|Superiority|||||||0.886|||||||Friedman’s two-way analysis of variance||||
1592720|NCT03074500|2928088|Superiority|||||||0.973|||||||Friedman’s two-way analysis of variance||||
1592721|NCT03074500|2928088|Superiority|||||||0.004|||||||Friedman’s two-way analysis of variance||||
1592722|NCT03074500|2928088|Superiority|||||||0.569||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592723|NCT03074500|2928088|Superiority|||||||0.519||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592724|NCT03074500|2928088|Superiority|||||||0.271||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1595340|NCT02960217|2933361|Superiority||||||<|0.0001|||||||Wilk-Shapiro test for normality||||
1592725|NCT03074500|2928088|Superiority|||||||0.362||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592726|NCT03074500|2928088|Superiority|||||||0.97||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592727|NCT03074500|2928088|Superiority|||||||0.404||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592728|NCT03074500|2928088|Superiority|||||||1||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592729|NCT03074500|2928088|Superiority|||||||0.733||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592730|NCT03074500|2928088|Superiority|||||||0.88||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592731|NCT03074500|2928088|Superiority|||||||0.518|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values|
1592732|NCT03074500|2928088|Superiority|||||||0.597|||||||Kruskal-Wallis|||Comparison of After Treatment Values|
1592733|NCT03074500|2928088|Superiority|||||||0.958|||||||Kruskal-Wallis|||Comparison of Baseline Values|
1592734|NCT03074500|2928089|Superiority|||||||0.235|||||||Kruskal-Wallis|||Immediate effect compared to baseline|
1592735|NCT03074500|2928089|Superiority|||||||0.084|||||||Kruskal-Wallis|||Immediate effect compared to baseline|
1592736|NCT03074500|2928089|Superiority|||||||0.447|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups|
1592737|NCT03074500|2928089|Superiority|||||||0.072|||||||Friedman’s two-way analysis of variance||||
1592738|NCT03074500|2928089|Superiority|||||||0.614|||||||Friedman’s two-way analysis of variance||||
1592739|NCT03074500|2928089|Superiority|||||||0.007|||||||Friedman’s two-way analysis of variance||||
1592740|NCT03074500|2928089|Superiority|||||||0.569||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592741|NCT03074500|2928089|Superiority|||||||0.058||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592742|NCT03074500|2928089|Superiority|||||||0.255||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592743|NCT03074500|2928089|Superiority|||||||0.909||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592744|NCT03074500|2928089|Superiority|||||||0.161||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592745|NCT03074500|2928089|Superiority|||||||0.24||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592746|NCT03074500|2928089|Superiority|||||||0.79||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592747|NCT03074500|2928089|Superiority|||||||0.909||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592748|NCT03074500|2928089|Superiority|||||||0.622||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592749|NCT03074500|2928089|Superiority|||||||0.172|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values|
1592750|NCT03074500|2928089|Superiority|||||||0.325|||||||Kruskal-Wallis|||Comparison of After Treatment Values|
1592751|NCT03074500|2928089|Superiority|||||||0.897|||||||Kruskal-Wallis|||Comparison of Baseline Values|
1592752|NCT03074500|2928090|Superiority|||||||0.004|||||||Friedman’s two-way analysis of variance||||
1592753|NCT03074500|2928090|Superiority|||||||0.483|||||||Friedman’s two-way analysis of variance||||
1592754|NCT03074500|2928090|Superiority|||||||0.001|||||||Friedman’s two-way analysis of variance||||
1592755|NCT03074500|2928090|Superiority|||||||0.318||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592756|NCT03074500|2928090|Superiority|||||||0.196||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592757|NCT03074500|2928090|Superiority|||||||0.023||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592758|NCT03074500|2928090|Superiority|||||||0.719||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592759|NCT03074500|2928090|Superiority|||||||0.183||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592760|NCT03074500|2928090|Superiority|||||||0.087||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592761|NCT03074500|2928090|Superiority|||||||0.56||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592762|NCT03074500|2928090|Superiority|||||||0.846||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592763|NCT03074500|2928090|Superiority|||||||0.699||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592764|NCT03074500|2928090|Superiority|||||||0.078|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values|
1592765|NCT03074500|2928090|Superiority|||||||0.215|||||||Kruskal-Wallis|||Comparison of After Treatment Values|
1592766|NCT03074500|2928090|Superiority|||||||0.837|||||||Kruskal-Wallis|||Comparison of Baseline Values|
1592767|NCT03074500|2928091|Superiority|||||||0.83|||||||Kruskal-Wallis|||Immediate effect compared to baseline|
1597175|NCT02915835|2935795|Superiority|||||||1|||||||Fisher Exact||||
1592768|NCT03074500|2928091|Superiority|||||||0.028|||||||Kruskal-Wallis|||Immediate effect compared to baseline|
1592769|NCT03074500|2928091|Superiority|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups|
1592770|NCT03074500|2928091|Superiority|||||||0.165|||||||Friedman’s two-way analysis of variance||||
1592771|NCT03074500|2928091|Superiority|||||||0.102|||||||Friedman’s two-way analysis of variance||||
1592772|NCT03074500|2928091|Superiority|||||||0.002|||||||Friedman’s two-way analysis of variance||||
1592773|NCT03074500|2928091|Superiority|||||||0.487||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592774|NCT03074500|2928091|Superiority|||||||0.013||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592775|NCT03074500|2928091|Superiority|||||||0.006||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592776|NCT03074500|2928091|Superiority|||||||0.117||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592777|NCT03074500|2928091|Superiority|||||||0.12||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592778|NCT03074500|2928091|Superiority|||||||0.002||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592779|NCT03074500|2928091|Superiority|||||||0.056||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592780|NCT03074500|2928091|Superiority|||||||1||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592781|NCT03074500|2928091|Superiority|||||||0.76||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592782|NCT03074500|2928091|Superiority|||||||0.008|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values|
1592783|NCT03074500|2928091|Superiority|||||||0.002|||||||Kruskal-Wallis|||Comparison of After Treatment Values|
1592784|NCT03074500|2928091|Superiority|||||||0.103|||||||Kruskal-Wallis|||Comparison of Baseline Values|
1592785|NCT03074500|2928092|Superiority|||||||1|||||||Kruskal-Wallis|||Immediate effect compared to baseline|
1592786|NCT03074500|2928092|Superiority|||||||0.041|||||||Kruskal-Wallis|||Immediate effect compared to baseline|
1592787|NCT03074500|2928092|Superiority|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||Comparison of immediate effect between groups|
1592788|NCT03074500|2928092|Superiority|||||||0.48|||||||Friedman’s two-way analysis of variance||||
1592789|NCT03074500|2928092|Superiority|||||||0.618|||||||Friedman’s two-way analysis of variance||||
1592790|NCT03074500|2928092|Superiority|||||||0.016|||||||Friedman’s two-way analysis of variance||||
1592791|NCT03074500|2928092|Superiority|||||||0.056||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592792|NCT03074500|2928092|Superiority|||||||0.036||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592793|NCT03074500|2928092|Superiority|||||||0.002||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592794|NCT03074500|2928092|Superiority|||||||0.935||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592795|NCT03074500|2928092|Superiority|||||||0.12||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592796|NCT03074500|2928092|Superiority|||||||0.129||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592797|NCT03074500|2928092|Superiority|||||||0.485||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592798|NCT03074500|2928092|Superiority|||||||0.482||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592799|NCT03074500|2928092|Superiority|||||||0.907||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Baseline Values|
1592800|NCT03074500|2928092|Superiority|||||||0.012|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values|
1592801|NCT03074500|2928092|Superiority|||||||0.227|||||||Kruskal-Wallis|||Comparison of After Treatment Values|
1592802|NCT03074500|2928092|Superiority|||||||0.715|||||||Kruskal-Wallis|||Comparison of Baseline Values|
1592803|NCT03074500|2928093|Superiority|||||||0.641|||||||Friedman’s two-way analysis of variance||||
1592804|NCT03074500|2928093|Superiority|||||||0.323|||||||Friedman’s two-way analysis of variance||||
1592805|NCT03074500|2928093|Superiority|||||||0.003|||||||Friedman’s two-way analysis of variance||||
1592806|NCT03074500|2928093|Superiority|||||||0.325||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592807|NCT03074500|2928093|Superiority|||||||0.019||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592808|NCT03074500|2928093|Superiority|||||||0.013||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592809|NCT03074500|2928093|Superiority|||||||0.449||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592810|NCT03074500|2928093|Superiority|||||||0.257||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1593745|NCT03028142|2930108|Other||LS Means ratio|1.06||||0.0039|2-Sided|95.0|1.02|1.1|||ANCOVA||||
1592811|NCT03074500|2928093|Superiority|||||||0.161||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592812|NCT03074500|2928093|Superiority|||||||0.596||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Before Treatment Values|
1592813|NCT03074500|2928093|Superiority|||||||0.344||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Before Treatment Values|
1592814|NCT03074500|2928093|Superiority|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of Before Treatment Values|
1592815|NCT03074500|2928093|Superiority|||||||0.015|||||||Kruskal-Wallis|||Comparison of 4 week After Treatment Values|
1592816|NCT03074500|2928093|Superiority|||||||0.282|||||||Kruskal-Wallis|||Comparison of After Treatment Values|
1592817|NCT03074500|2928093|Superiority|||||||0.633|||||||Kruskal-Wallis|||Comparison of Before Treatment Values|
1592818|NCT03074500|2928094|Superiority|||||||0.192|||||||Friedman’s two-way analysis of variance||||
1592819|NCT03074500|2928094|Superiority|||||||0.67|||||||Friedman’s two-way analysis of variance||||
1592820|NCT03074500|2928094|Superiority|||||||0.004|||||||Friedman’s two-way analysis of variance||||
1592821|NCT03074500|2928094|Superiority|||||||0.545||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Value|
1592822|NCT03074500|2928094|Superiority|||||||0.021||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592823|NCT03074500|2928094|Superiority|||||||0.023||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of 4 week After Treatment Values|
1592824|NCT03074500|2928094|Superiority|||||||0.427||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592825|NCT03074500|2928094|Superiority|||||||0.014||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592826|NCT03074500|2928094|Superiority|||||||0.019||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of After Treatment Values|
1592827|NCT03074500|2928094|Superiority|||||||0.326||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of baseline values|
1592828|NCT03074500|2928094|Superiority|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of baseline values|
1592829|NCT03074500|2928094|Superiority|||||||0.677||||||p-value is adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|p<0.017 is significant||Comparison of baseline values|
1592830|NCT03074500|2928094|Superiority|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Comparison of 4 week After Treatment Values|
1592831|NCT03074500|2928094|Superiority|||||||0.018|||||||Kruskal-Wallis|||Comparison of After Treatment Values|
1592832|NCT03074500|2928094|Superiority|||||||0.643|||||||Kruskal-Wallis|||Comparison of baseline values|
1592833|NCT03074331|2928099|Superiority|||||||0.009|||||||2-sided exact 1-sample binomial test|||The SVR12 rate was compared to the pre-specified performance goal of 85% by using a two-sided exact one-sample binomial test at the 0.05 significance level.|
1592834|NCT03074162|2928103|Equivalence|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.|Geometric Mean (gMean) Ratio (%)|83.57|Standard Error of the Mean|72.45|||2-Sided|90.0|66.33|105.31|||||gMean Ratio=(B/A) *100. Standard Error of the mean is actually intra-individual geometric coefficient of variation||
1592835|NCT03074162|2928103|Equivalence|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.|Geometric Mean (gMean) Ratio (%)|49.6|Standard Error of the Mean|38.13|||2-Sided|90.0|43.39|56.71|||||gMean Ratio=(B/R) *100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.||
1592836|NCT03074162|2928104|Equivalence|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with A.|Geometric Mean (gMean) Ratio (%)|85.56|Standard Error of the Mean|42.05|||2-Sided|90.0|74.11|98.77|||||gMean Ratio=(B/A) *100. Standard Error of the mean is actually intra-individual geometric coefficient of variation||
1592837|NCT03074162|2928104|Equivalence|The statistical model was an variance (ANOVA) on the logarithmic scale including fixed effects for sequence, subject nested within sequence, period and treatment for comparison of B with R.|Geometric Mean (gMean) Ratio (%)|45.54|Standard Error of the Mean|35.99|||2-Sided|90.0|40.11|51.7|||||gMean Ratio=(B/R) *100. Standard Error of the mean is actually intra-individual geometric coefficient of variation.||
1592838|NCT03073486|2928129|Other|||||||0.1361|||||||Regression, Logistic|Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation|||
1592839|NCT03073486|2928130|Other|||||||0.6888|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation|||
1592840|NCT03073486|2928131|Other|||||||0.2301|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation|||
1592841|NCT03073200|2928132|Superiority||Mean Difference (Final Values)|23.0||||0.07|2-Sided|95.0|0.6|45.4|||Fisher Exact||||
1592842|NCT03073200|2928133|Superiority||Mean Difference (Final Values)|20.9||||0.089|2-Sided|95.0|0.1|41.7|||Fisher Exact||||
1592843|NCT03073200|2928136|Superiority||Mean Difference (Final Values)|-12.01|Standard Deviation|3.853||0.006|2-Sided|95.0|-20.11|-3.9|||Mixed Models Analysis||||
1592844|NCT03073200|2928137|Superiority||Mean Difference (Final Values)|-15.36|Standard Error of the Mean|1.682|<|0.001|2-Sided|95.0|-18.69|-12.04|||Mixed Models Analysis||||
1592845|NCT03073200|2928138|Superiority||Mean Difference (Final Values)|-17.04|Standard Error of the Mean|5.747||0.005|2-Sided|95.0|-28.7|-5.38|||Mixed Models Analysis||||
1592846|NCT03073200|2928139|Superiority||Mean Difference (Final Values)|41.1|||<|0.001|2-Sided|95.0|27.0|55.2|||Fisher Exact||||
1592847|NCT03073200|2928140|Superiority||Mean Difference (Final Values)|51.1|||<|0.001|2-Sided|95.0|35.3|66.9|||Fisher Exact||||
1592848|NCT03073200|2928141|Superiority||Mean Difference (Final Values)|40.7|||<|0.001|2-Sided|95.0|29.3|52.0|||Fisher Exact||||
1592849|NCT03073200|2928142|Superiority||Mean Difference (Final Values)|45.0|||<|0.001|2-Sided|95.0|33.2|56.8|||Fisher Exact||||
1592850|NCT03073200|2928143|Superiority||Mean Difference (Final Values)|47.8|||<|0.001|2-Sided|95.0|38.0|57.6|||Fisher Exact||||
1592851|NCT03073200|2928144|Superiority||Mean Difference (Final Values)|50.4|||<|0.001|2-Sided|95.0|40.6|60.2|||Fisher Exact||||
1592852|NCT03073200|2928145|Superiority||Mean Difference (Final Values)|72.9|||<|0.001|2-Sided|95.0|63.3|82.5|||Fisher Exact||||
1592853|NCT03073200|2928146|Superiority||Mean Difference (Final Values)|70.2|||<|0.001|2-Sided|95.0|59.3|81.0|||Fisher Exact||||
1592854|NCT03073200|2928147|Superiority||Mean Difference (Final Values)|63.7|||<|0.001|2-Sided|95.0|51.0|76.4|||Fisher Exact||||
1592855|NCT03072875|2928149|Other|Descriptive statistic.|||||||||||||||||Quantitative data (descriptive statistic) from the USAQ were used to determine feasibility. Specifically, we established an a priori mean score of 3.5 or greater on the USAQ to determine feasibility.
1592856|NCT03072719|2928152|Superiority or Other||Least square (LS) mean difference|-0.19||||0.1774|2-Sided|95.0|-0.46|0.09||From ANCOVA model: Treatment as fixed factor, baseline Schiff Sensitivity score as covariate.|ANCOVA||Difference is 0.454% stannous fluoride minus 0.76% sodium monofluorophosphate such that a negative difference favours first named treatment.|"H0 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is zero.~H1 : The difference in Schiff Sensitivity Score at Day 14 between the experimental dentifrice and reference dentifrice is not zero."|
1592857|NCT03071263|2928169|Superiority|||||||0.6367||||||Baseline AOBP SBP as a covariate and treatment group, baseline serum potassium (K+ 4.3-<4.7 or 4.7-5.1 mEq/L), and history of Type 1 or Type 2 diabetes mellitus as factors in the model.|ANCOVA|||The p-value is from a test comparing the difference between two groups in the mean change in AOBP SBP from baseline.|
1592858|NCT03071263|2928170|Superiority|||||||0.5757||||||Baseline AOBP SBP as a covariate and treatment group, baseline serum potassium (K+ 4.3-<4.7 or 4.7-5.1 mEq/L), and history of Type 1 or Type 2 diabetes mellitus (Yes or No) as factors in the model.|ANCOVA||||
1592859|NCT03071263|2928171|Superiority||||||<|0.0001||||||α-level 0.05. Stratified by baseline potassium category (4.3-<4.7 mEq/L or 4.7-5.1 mEq/L) and history of Type 1 or Type 2 diabetes mellitus (Yes or No) as randomized|Cochran-Mantel-Haenszel|||A sample size of 280 subjects has 90% power to detect a difference between treatment groups of 20% or more in the proportion of subjects remaining on spironolactone at Week 12, at α = 0.05.|
1592860|NCT03070470|2928248|Other|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|30.7|||||2-Sided|90.0|22.6|38.9||||||Upper bound of the 2–sided 90% CI to be ≥10 msec for the projected placebo-corrected change from baseline QTc effect at the peak plasma level on Day 1 using a linear mixed-effects exposure response model.|
1592861|NCT03070470|2928249|Other|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|-2.9|||||2-Sided|90.0|-14.6|8.8||||||Upper bound of the 2-sided 90% confidence interval (CI) to be <10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model|
1592862|NCT03070470|2928249|Other|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|-2.6|||||2-Sided|90.0|-11.4|6.1||||||Upper bound of the 2-sided 90% confidence interval (CI) to be <10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model|
1592863|NCT03070470|2928249|Other|The appropriateness of the linear model will be assessed. Projected estimates will be computed only if the linear model is found acceptable.|Mean Difference (Final Values)|1.2|||||2-Sided|90.0|-9.5|12.0||||||Upper bound of the 2-sided 90% confidence interval (CI) to be <10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model|
1592864|NCT03070431|2928259|Superiority|It was assumed that radiotherapy with 5x4 Gy results in 6-month LPFS of 67% and an increase by 20% is clinically relevant when using 5x5 Gy. For comparison of 5x5 Gy and a historical control (5x4 Gy), it was assumed that it can be performed with a simple Pearson-Chi-Square test (2-sided significance level of 5%, power of 79%) if 40 patients treated with 5x5 Gy and 400 patients of the control group qualified for Propensity-Score adjusted comparison, assuming 6-month LPFS rates of 87% and 67%.|Risk Difference (RD)|20.0|||<|0.05|2-Sided||||||Cochran-Mantel-Haenszel|||historical control group treated with 5 x 4 Gy|"In a prospective study, 6-month LPFS rates were 86% after longer-course (mainly 3Gyx10) and 67% after short-course radiotherapy (mainly 4Gyx5) [Rades D, et al., Int J Radiat Oncol Biol Phys 2009;73:228-34.]. For sample size calculations, it was assumed that conventional radiotherapy with 4Gyx5 results in 6-month LPFS of 67% and that an increase by 20% is clinically relevant and realistic with 5Gyx5. A sample size of 40 eligible patients was required for the phase 2 trial assuming that that 6-month LPFS would be 87% and estimated with a precision of +/-20% expressed as the half length of the associated two-sided confidence interval (95%), and power of >=80%.~For comparison of phase 2 cohort and historical control group, it was assumed that this could be performed with a simple Pearson-Chi-Square test using a two-sided significance level of 5% (10%) and a power of 79% (86%) if 40 patients received 5Gyx5 and N=400 of the control group qualified for Propensity-Score adjusted comparison."
1592865|NCT03070171|2928261|Equivalence|Bioequivalence was established by ensuring that the T/R ratio of AUC0-∞ of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.43158|||||2-Sided|90.0|101.87254|115.41292|||||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for ‘sequence’, ‘subjects nested within sequences’, ‘period’ and ‘treatment’.|
1592929|NCT03066609|2928433|Superiority||Odds Ratio (OR)|114.85|||<|0.0001|2-Sided|95.0|26.94|489.59|||Regression, Logistic|||PASI 90|
1592866|NCT03070171|2928262|Equivalence|Bioequivalence was established by ensuring that the T/R ratio of AUC0-∞ of total dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|107.83324|||||2-Sided|90.0|101.25584|114.8379|||||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for ‘sequence’, ‘subjects nested within sequences’, ‘period’ and ‘treatment’.|
1592867|NCT03070171|2928263|Equivalence|Bioequivalence was established by ensuring that the T/R ratio of Cmax of total dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|106.69566|||||2-Sided|90.0|99.50139|114.4101|||||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for ‘sequence’, ‘subjects nested within sequences’, ‘period’ and ‘treatment’.|
1592868|NCT03070171|2928264|Equivalence|Bioequivalence was established by ensuring that the T/R ratio of Cmax of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|107.61507|||||2-Sided|90.0|100.61938|115.09714|||||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for ‘sequence’, ‘subjects nested within sequences’, ‘period’ and ‘treatment’.|
1592869|NCT03070171|2928265|Equivalence|Bioequivalence was established by ensuring that the T/R ratio of Cmax of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.9587|||||2-Sided|90.0|101.78627|116.63654|||||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for ‘sequence’, ‘subjects nested within sequences’, ‘period’ and ‘treatment’.|
1592870|NCT03070171|2928266|Equivalence|Bioequivalence was established by ensuring that the T/R ratio of AUC0-tz of free dabigatran was within the pre-specified acceptance range (80%-125%).|T/R Ratio|108.46909|||||2-Sided|90.0|101.44605|115.97833|||||Confidence intervals were calculated based on the residual error from ANOVA. Ratio calculated as Dabigatran Etexilate Tablet (T) divided by Dabigatran Etexilate capsule (R).|The statistical model was an analysis of variance (ANOVA) on the logarithmic scale including effects for ‘sequence’, ‘subjects nested within sequences’, ‘period’ and ‘treatment’.|
1592871|NCT03069482|2928367|Superiority||Trimmed mean difference|5.83333|Standard Error of the Mean|2.3||0.27411|2-Sided|95.0|-4.88|16.54|||Yuen's trimmed means t-test||||
1592872|NCT03069482|2928368|Superiority||Trimmed mean difference|2.22222|Standard Error of the Mean|1.75||0.50537|2-Sided|95.0|-4.492|8.943|||Yuen's trimmed means t-test||||
1592873|NCT03069482|2928369|Superiority||Trimmed mean difference|7.79514|Standard Error of the Mean|2.16||0.109|2-Sided|95.0|-1.867|17.457|||Yuen's trimmed means t-test||||
1592874|NCT03069482|2928370|Superiority||Trimmed mean difference|8.29574|Standard Error of the Mean|2.11||0.046|2-Sided|95.0|0.138|16.453|||Yuen's trimmed mean t-test||||
1592875|NCT03069482|2928372|Other||Percent of respondents|58.0|||||2-Sided||||||||||
1592876|NCT03069482|2928373|Other||Percent retention relative to target|98.3|||||2-Sided||||||||||We calculated the percent of retained participants relative to the retention target (N = 62)
1592877|NCT03069482|2928374|Other||Percent accrual relative to target N|102.0|||||2-Sided||||||||||The goal of this outcome was to determine whether the trial could reach its enrollment target (90 participants).
1592878|NCT03069482|2928375|Superiority||Risk Ratio (RR)|2.103|Standard Deviation|0.369||0.044|2-Sided|95.0|1.2|2.6|||Mixed Models Analysis|Zero inflated negative binomial mixed methods regression.|||
1592879|NCT03069482|2928376|Superiority||Slope|1.063|Standard Deviation|3.377|=|0|2-Sided||||||ANOVA||||
1592880|NCT03069352|2928380|Other||Hazard Ratio (HR)|0.717||||0.049|2-Sided|95.0|0.514|1.0|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.||
1592881|NCT03069352|2928380|Other||Hazard Ratio (HR)|0.704||||0.04|2-Sided|95.0|0.503|0.985|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - < 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - < 75, ≥ 75).||
1592882|NCT03069352|2928384|Superiority|||||||0.277|||||||Fisher Exact||||
1592883|NCT03069352|2928384|Superiority|||||||0.162|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - < 75, ≥ 75) and AML status (de novo, secondary).|||
1592884|NCT03069352|2928385|Superiority|||||||0.277|||||||Fisher Exact||||
1592885|NCT03069352|2928385|Superiority|||||||0.162|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - < 75, ≥ 75) and AML status (de novo, secondary).|||
1592886|NCT03069352|2928386|Superiority||Slope|17.7|||||2-Sided|95.0|-0.4|35.8|||||||
1592887|NCT03069352|2928387|Superiority||Treatment Difference|22.4|||||2-Sided|95.0|9.0|35.8|||||||
1592888|NCT03069352|2928388|Superiority|||||||0.039|||||||Fisher Exact||||
1592889|NCT03069352|2928388|Superiority||Treatment Difference|15.2||||0.04|2-Sided|95.0|1.4|29.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - < 75, ≥ 75) and AML status (de novo, secondary).|Treatment difference = Venetoclax - Placebo||
1592890|NCT03069352|2928389|Superiority||||||<|0.001|||||||Fisher Exact||||
1592891|NCT03069352|2928389|Superiority||Treatment Difference|22.9|||<|0.001|2-Sided|95.0|10.8|35.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - < 75, ≥ 75) and AML status (de novo, secondary).|Treatment difference = Venetoclax - Placebo||
1592892|NCT03069352|2928390|Superiority||Hazard Ratio (HR)|0.601||||0.003|2-Sided|95.0|0.43|0.839|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.||
1592893|NCT03069352|2928390|Superiority||Hazard Ratio (HR)|0.583||||0.002|2-Sided|95.0|0.416|0.817|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 - < 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 - < 75, ≥ 75).||
1592894|NCT03069352|2928391|Superiority|||||||0.085|||||||Linear Mixed Effects Regression Model|Model included AML status (de novo vs. secondary), age (18-< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors||A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.|
1592895|NCT03069352|2928391|Other||LS Mean Difference|6.381|Standard Error of the Mean|7.511|||2-Sided|95.0|-8.49|21.26|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 9 Day 1|
1592896|NCT03069352|2928391|Other||LS Mean Difference|7.119|Standard Error of the Mean|6.031|||2-Sided|95.0|-4.83|19.06|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 7 Day 1|
1592897|NCT03069352|2928391|Other||LS Mean Difference|13.388|Standard Error of the Mean|5.659|||2-Sided|95.0|2.18|24.59|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 5 Day 1|
1592898|NCT03069352|2928391|Other||LS Mean Difference|2.917|Standard Error of the Mean|4.617|||2-Sided|95.0|-6.23|12.06|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 3 Day 1|
1592899|NCT03069352|2928392|Superiority|||||||0.126|||||||Linear Mixed Effects Regression Model|Model included AML status (de novo vs. secondary), age (18–< 75 vs. ≥ 75), treatment arm, time, and treatment arm by time interaction as fixed factors||A linear mixed effects regression model with a variable covariance structure was fitted to the longitudinal data (considering all time points) to test for differences between treatment arms.|
1592900|NCT03069352|2928392|Other||LS Mean Difference|-1.648|Standard Error of the Mean|3.176|||2-Sided|95.0|-7.94|4.64|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 9 day 1|
1592901|NCT03069352|2928392|Other||LS Mean Difference|-0.807|Standard Error of the Mean|2.609|||2-Sided|95.0|-5.98|4.36|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 7 Day 1|
1592902|NCT03069352|2928392|Other||LS Mean Difference|-4.923|Standard Error of the Mean|2.58|||2-Sided|95.0|-10.03|0.19|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 5 Day 1|
1592903|NCT03069352|2928392|Other||LS Mean Difference|-4.507|Standard Error of the Mean|2.068|||2-Sided|95.0|-8.6|-0.41|||||A linear mixed-effects regression model with a covariance structure including baseline score, stratification factors (age and AML status) treatment arm, visit, and treatment arm by visit interaction.|Cycle 3, Day 1|
1592904|NCT03069352|2928393|Superiority||||||<|0.001|||||||Fisher Exact||||
1592905|NCT03069352|2928393|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - < 75, ≥ 75) and AML status (de novo, secondary).|||
1592906|NCT03069352|2928394|Superiority||||||<|0.001|||||||Fisher Exact||||
1592907|NCT03069352|2928394|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - < 75, ≥ 75) and AML status (de novo, secondary).|||
1592908|NCT03069352|2928395|Superiority||||||<|0.001|||||||Fisher Exact||||
1592909|NCT03069352|2928395|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - < 75, ≥ 75) and AML status (de novo, secondary).|||
1592910|NCT03069352|2928396|Superiority||||||<|0.001|||||||Fisher Exact||||
1592911|NCT03069352|2928396|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - < 75, ≥ 75) and AML status (de novo, secondary).|||
1592912|NCT03069352|2928397|Superiority||||||<|0.001|||||||Fisher Exact||||
1592913|NCT03069352|2928397|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by age (18 - < 75, ≥ 75) and AML status (de novo, secondary).|||
1592914|NCT03069352|2928398|Superiority||Hazard Ratio (HR)|0.743||||0.103|2-Sided|95.0|0.521|1.061|||Log Rank|Unstratified analysis|The hazard ratio was estimated using the Cox proportional hazards model.||
1592915|NCT03069352|2928398|Superiority||Hazard Ratio (HR)|0.749||||0.114|2-Sided|95.0|0.524|1.071|||Log Rank|Log-rank test stratified by AML status (de novo, secondary) and age (18 – < 75, ≥ 75).|The hazard ratio was estimated using the Cox proportional hazards model, stratified by AML status (de novo, secondary) and age (18 – < 75, ≥ 75).||
1592916|NCT03069313|2928400|Other||||||<|0.0001|||||||t-test, 2 sided|||This analysis is comparing ESS before and after treatment.|
1592917|NCT03069313|2928400|Other||||||<|0.09|||||||t-test, 2 sided|||This analysis is comparing FWB before and after treatment.|
1592918|NCT03069313|2928400|Other||||||<|0.0001|||||||t-test, 2 sided|||This analysis is comparing PWB before and after treatment.|
1592919|NCT03069313|2928400|Other||||||<|0.056|||||||t-test, 2 sided|||This analysis is comparing EWB before and after treatment.|
1592920|NCT03069313|2928400|Other|This analysis is comparing SWB before and after treatment.|||||<|0.133|||||||t-test, 2 sided||||
1592921|NCT03069313|2928401|Other|||||||0.0003|||||||t-test, 2 sided||||
1592922|NCT03069313|2928402|Other|Paired t-test|||||<|0.0001|||||||t-test, 1 sided||||
1592923|NCT03068611|2928405|Superiority|||||||0.92|||||||t-test, 2 sided|Data were log-transformed to correct positive skewness|||
1592924|NCT03068611|2928406|Superiority|||||||0.36|||||||t-test, 2 sided|Data were log-transformed transformed due to positive skewness|||
1592925|NCT03068611|2928407|Superiority|||||||0.54|||||||Chi-squared||||
1592926|NCT03068611|2928408|Superiority|||||||0.9|||||||Chi-squared||||
1592927|NCT03068312|2928409|Other||Least squares mean difference|-0.66|||||2-Sided|95.0|-1.1|-0.21|||||||
1592928|NCT03066609|2928433|Superiority||Odds Ratio (OR)|246.12|||<|0.0001|2-Sided|95.0|58.41|1037.1|||Regression, Logistic|||PASI 90|
1592930|NCT03066609|2928434|Superiority||Odds Ratio (OR)|149.71|||<|0.0001|2-Sided|95.0|51.83|432.42|||Regression, Logistic|||IGA|
1592931|NCT03066609|2928434|Superiority||Odds Ratio (OR)|75.82|||<|0.0001|2-Sided|95.0|25.81|222.72|||Regression, Logistic|||IGA|
1592932|NCT03066609|2928435|Superiority||Odds Ratio (OR)|557.98|||<|0.0001|2-Sided|95.0|187.2|1663.4|||Regression, Logistic|||PASI 75|
1592933|NCT03066609|2928435|Superiority||Odds Ratio (OR)|153.94|||<|0.0001|2-Sided|95.0|54.02|438.67|||Regression, Logistic|||PASI 75|
1592934|NCT03066102|2928437|Other|||||||0.466||||||The level of statistical significance was set at P < 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of serratus anterior during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."|
1592935|NCT03066102|2928437|Other|||||||0.843||||||The level of statistical significance was set at P < 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of lower trapezius during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."|
1592936|NCT03066102|2928437|Other|||||||0.5||||||The level of statistical significance was set at P < 0.05|ANOVA|||"The effects of muscle fatigue on muscle onset timing of upper trapezius during scaption.~Muscle fatigue would change muscle onset timing during scaption. One-way repeated measures analysis of variance."|
1592937|NCT03066102|2928438|Other|||||||0.05||||||The level of statistical significance was adjusted at P<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 60~30 degree of scaption.~One-way repeated measures analysis of variance."|
1592938|NCT03066102|2928438|Other|||||||0.035||||||The level of statistical significance was adjusted at P<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 90~60 degree of scaption.~One-way repeated measures analysis of variance."|
1592939|NCT03066102|2928438|Other|||||||0.002||||||The level of statistical significance was adjusted at P<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during descending 120~90 degree of scaption.~One-way repeated measures analysis of variance."|
1592940|NCT03066102|2928438|Other|||||||0.002||||||The level of statistical significance was adjusted at P<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 90~120 degree of scaption.~One-way repeated measures analysis of variance."|
1592941|NCT03066102|2928438|Other|||||||0.018||||||The level of statistical significance was adjusted at P<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 60~90 degree of scaption.~One-way repeated measures analysis of variance."|
1592942|NCT03066102|2928438|Other|||||||0.021||||||The level of statistical significance was adjusted at P<0.0083. (0.05/6=0.0083)|ANOVA|||"The effects of time on muscle activation changed of serratus anterior during ascending 30~60 degree of scaption.~One-way repeated measures analysis of variance."|
1592943|NCT03066102|2928438|Other|||||||0.042||||||The level of statistical significance was set at P < 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of serratus anterior during each angle of scaption."|
1592944|NCT03066102|2928438|Other|||||||0.627||||||The level of statistical significance was set at P < 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of lower trapezius during each angle of scaption."|
1592945|NCT03066102|2928438|Other|||||||0.331||||||The level of statistical significance was set at P < 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scaption.~Muscle fatigue would change muscle activation during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on muscle activation changed of upper trapezius during each angle of scaption."|
1592946|NCT03066102|2928439|Other|||||||0.263||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 30 degree of scaption.~One-way repeated measures analysis of variance."|
1592947|NCT03066102|2928439|Other|||||||0.542||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 60 degree of scaption.~One-way repeated measures analysis of variance."|
1592948|NCT03066102|2928439|Other|||||||0.389||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 90 degree of scaption.~One-way repeated measures analysis of variance."|
1592949|NCT03066102|2928439|Other|||||||0.083||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during descending 120 degree of scaption.~One-way repeated measures analysis of variance."|
1592950|NCT03066102|2928439|Other|||||||0.005||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."|
1592951|NCT03066102|2928439|Other|||||||0.021||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."|
1592952|NCT03066102|2928439|Other|||||||0.141||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."|
1592953|NCT03066102|2928439|Other|||||||0.65||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular upward rotation during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."|
1592954|NCT03066102|2928439|Other|||||||0.001||||||The level of statistical significance was set at P < 0.05.|ANOVA|||The effects of muscle fatigue on scapular upward rotation during scaption. Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular upward rotation during each angle of scaption.|
1592955|NCT03066102|2928439|Other|||||||0.406||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 30 degree of scaption.~One-way repeated measures analysis of variance."|
1592956|NCT03066102|2928439|Other|||||||0.636||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 60 degree of scaption.~One-way repeated measures analysis of variance."|
1592957|NCT03066102|2928439|Other|||||||0.137||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 90 degree of scaption.~One-way repeated measures analysis of variance."|
1592958|NCT03066102|2928439|Other|||||||0.002||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during descending 120 degree of scaption.~One-way repeated measures analysis of variance."|
1592959|NCT03066102|2928439|Other|||||||0.004||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."|
1592960|NCT03066102|2928439|Other|||||||0.311||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."|
1592961|NCT03066102|2928439|Other|||||||0.457||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."|
1592962|NCT03066102|2928439|Other|||||||0.296||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular internal rotation during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."|
1592963|NCT03066102|2928439|Other|||||||1.5e-05||||||The level of statistical significance was set at P < 0.05.|ANOVA|||The effects of muscle fatigue on scapular internal rotation during scaption Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular internal rotation during each angle of scaption.|
1592964|NCT03066102|2928439|Other|||||||0.032||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 30 degree of scaption.~One-way repeated measures analysis of variance."|
1592965|NCT03066102|2928439|Other|||||||0.059||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 60 degree of scaption.~One-way repeated measures analysis of variance."|
1592966|NCT03066102|2928439|Other|||||||0.007||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 90 degree of scaption.~One-way repeated measures analysis of variance."|
1592967|NCT03066102|2928439|Other|||||||1.2e-05||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during descending 120 degree of scaption.~One-way repeated measures analysis of variance."|
1592968|NCT03066102|2928439|Other|||||||0.000147||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 120 degree of scaption.~One-way repeated measures analysis of variance."|
1592969|NCT03066102|2928439|Other|||||||0.04||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 90 degree of scaption.~One-way repeated measures analysis of variance."|
1592970|NCT03066102|2928439|Other|||||||0.062||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 60 degree of scaption.~One-way repeated measures analysis of variance."|
1592971|NCT03066102|2928439|Other|||||||0.093||||||The level of statistical significance was adjusted at P<0.00625. (0.05/8=0.00625)|ANOVA|||"The effects of time on kinematics changed of scapular posterior tilt during ascending 30 degree of scaption.~One-way repeated measures analysis of variance."|
1592972|NCT03066102|2928439|Other|||||||0.000467||||||The level of statistical significance was set at P < 0.05.|ANOVA|||The effects of muscle fatigue on scapular posterior tilt during scaption. Muscle fatigue would change scapular kinematics during scaption. Two way (angle x time) repeated measures. If there was an interaction between time and angle, further one way repeated measures would use to access the effects of time on kinematics changed of scapular posterior tilt during each angle of scaption.|
1592973|NCT03066102|2928440|Other|||||||0.382||||||The level of statistical significance was set at P < 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of lower trapezius during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."|
1592974|NCT03066102|2928440|Other|||||||0.037||||||The level of statistical significance was set at P < 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of upper trapezius during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."|
1593005|NCT03064113|2928514|Superiority||Difference of LS Mean|29.1|||<|0.001|2-Sided|95.0|20.8|37.4|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs|
1608196|NCT02610868|2953671|Superiority||||||<|0.0001|||||||ANCOVA||||
1592975|NCT03066102|2928440|Other|||||||8.5e-05||||||The level of statistical significance was set at P < 0.05.|ANOVA|||"The effects of muscle fatigue on muscle strength of serratus anterior during maximum voluntary isometric muscle contraction.~Muscle fatigue would decrease muscle strength during maximum voluntary isometric muscle contraction.~One-way repeated measures analysis of variance."|
1592976|NCT03066102|2928441|Other|||||||0.037||||||The level of statistical significance was set at P < 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."|
1592977|NCT03066102|2928441|Other|||||||0.096||||||The level of statistical significance was set at P < 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."|
1592978|NCT03066102|2928441|Other|||||||0.154||||||The level of statistical significance was set at P < 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scapular protraction.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."|
1592979|NCT03066102|2928441|Other|||||||0.006||||||The level of statistical significance was set at P < 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of serratus anterior during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."|
1592980|NCT03066102|2928441|Other|||||||0.984||||||The level of statistical significance was set at P < 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of lower trapezius during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."|
1592981|NCT03066102|2928441|Other|||||||0.413||||||The level of statistical significance was set at P < 0.05.|ANOVA|||"The effects of muscle fatigue on muscle activation of upper trapezius during scapular elevation.~Muscle fatigue would change muscle activation during proprioception task. One-way repeated measures analysis of variance."|
1592982|NCT03066102|2928442|Other|||||||0.764||||||The level of statistical significance was set at P < 0.05.|ANOVA|||The effects of muscle fatigue on reposition error of scapular protraction. Muscle fatigue would increase reposition error during scapular protraction. One-way repeated measures analysis of variance.|
1592983|NCT03066102|2928442|Other|||||||0.227||||||The level of statistical significance was set at P < 0.05.|ANOVA|||The effects of muscle fatigue on reposition error of scapular elevation. Muscle fatigue would increase reposition error during scapular elevation. One-way repeated measures analysis of variance.|
1592984|NCT03065530|2928461|Other||||||<|0.05|||||||Kruskal-Wallis|||The sample size was calculated on the basis of an our initial pilot study, and the SD was 1.4 between the four groups. We hypothesized that the differences in VAS between the four groups and the SDs would be 15%. A power analysis suggested that there will be 80% power to detect differences at an α=0.05 significance level (two-tailed), including 24 individuals per treatment group. Considering the exclusion of 25% of patients, 30 parturients were eventually recruited in each group.|
1592985|NCT03065283|2928465|Equivalence|p< or = 0.05|Mean Difference (Final Values)|0.09||||0.05|2-Sided|95.0|-0.38|0.57|||t-test, 2 sided|||A paired t-test was used for intragroup analysis, and an independent Student’s t-test was used for intergroup analysis. Data are represented in mean between-group difference with a 95% CI, and analysis was by intention to treat.|
1592986|NCT03064113|2928510|Superiority||Difference of LS Mean|2654.7||||0.009|2-Sided|95.0|689.7|4619.6|||t-test, 2 sided||||
1592987|NCT03064113|2928510|Superiority||Difference of LS Mean|5888.9|||<|0.001|2-Sided|95.0|3924.4|7853.4|||t-test, 2 sided||||
1592988|NCT03064113|2928510|Superiority||Difference of LS Mean|3975.5|||<|0.001|2-Sided|95.0|2007.3|5943.7|||t-test, 2 sided||||
1592989|NCT03064113|2928512|Superiority||Difference of LS Mean|0.0||||0.287|2-Sided|95.0|-0.1|0.0|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr|
1592990|NCT03064113|2928512|Superiority||Difference of LS Mean|0.0||||0.422|2-Sided|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr|
1592991|NCT03064113|2928512|Superiority||Difference of LS Mean|0.0||||0.183|2-Sided|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr|
1592992|NCT03064113|2928512|Superiority||Difference of LS Mean|0.0||||0.503|2-Sided|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr|
1592993|NCT03064113|2928512|Superiority||Difference of LS Mean|0.1||||0.045|2-Sided|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr|
1592994|NCT03064113|2928512|Superiority||Difference of LS Mean|0.1||||0.054|2-Sided|95.0|0.0|0.1|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr|
1592995|NCT03064113|2928513|Superiority||Difference of LS Mean|0.1||||0.007|2-Sided|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr|
1592996|NCT03064113|2928513|Superiority||Difference of LS Mean|0.1||||0.048|2-Sided|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr|
1592997|NCT03064113|2928513|Superiority||Difference of LS Mean|0.1||||0.003|2-Sided|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 24 hr|
1592998|NCT03064113|2928513|Superiority||Difference of LS Mean|0.1||||0.003|2-Sided|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr|
1592999|NCT03064113|2928513|Superiority||Difference of LS Mean|0.1||||0.046|2-Sided|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr|
1593000|NCT03064113|2928513|Superiority||Difference of LS Mean|0.1||||0.003|2-Sided|95.0|0.0|0.2|||t-test, 2 sided|||Tx Difference of LS Mean 12 hr|
1593001|NCT03064113|2928514|Superiority||Difference of LS Mean|10.6||||0.01|2-Sided|95.0|2.5|18.6|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hr|
1593002|NCT03064113|2928514|Superiority||Difference of LS Mean|25.4|||<|0.001|2-Sided|95.0|17.4|33.4|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hrs|
1593003|NCT03064113|2928514|Superiority||Difference of LS Mean|20.1|||<|0.001|2-Sided|95.0|12.1|28.2|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-24 hrs|
1593004|NCT03064113|2928514|Superiority||Difference of LS Mean|25.6|||<|0.001|2-Sided|95.0|17.3|33.9|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs|
1593746|NCT03028142|2930108|Other||LS Means ratio|1.02||||0.2496|2-Sided|95.0|0.98|1.06|||ANCOVA||||
1593006|NCT03064113|2928514|Superiority||Difference of LS Mean|26.4|||<|0.001|2-Sided|95.0|18.0|34.8|||t-test, 2 sided|||Tx Difference of LS Mean AUC, 0-12 hrs|
1593007|NCT03064113|2928515|Superiority|Tx Difference of LS Mean FEV1 at 24 hr|Difference of LS Mean|-24.2||||0.327|2-Sided|95.0|-72.9|24.6|||t-test, 2 sided||||
1593008|NCT03064113|2928515|Superiority||Difference of LS Mean|136.6|||<|0.001|2-Sided|95.0|87.8|185.3|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 24 hr|
1593009|NCT03064113|2928515|Superiority||Difference of LS Mean|102.8|||<|0.001|2-Sided|95.0|54.1|151.5|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 24 hr|
1593010|NCT03064113|2928515|Superiority||Difference of LS Mean|15.3|||<|0.659|2-Sided|95.0|-53.5|94.1|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr|
1593011|NCT03064113|2928515|Superiority||Difference of LS Mean|123.4|||<|0.001|2-Sided|95.0|54.6|192.3|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr|
1593012|NCT03064113|2928515|Superiority||Slope|112.5|||<|0.001|2-Sided|95.0|44.5|180.5|||t-test, 2 sided|||Tx Difference of LS Mean FEV1 at 12 hr|
1593013|NCT03064113|2928516|Superiority||Difference of LS Mean|175.6|||<|0.001|2-Sided|95.0|114.1|237.2|||t-test, 2 sided||||
1593014|NCT03064113|2928516|Superiority||Difference of LS Mean|169.3|||<|0.001|2-Sided|95.0|107.8|230.8|||t-test, 2 sided||||
1593015|NCT03064113|2928516|Superiority||Difference of LS Mean|173.8|||<|0.001|2-Sided|95.0|112.4|235.3|||t-test, 2 sided||||
1593016|NCT03063385|2928532|Other|[Not specified]|Slope|0.0158|Standard Error of the Mean|0.0068||0.0204|2-Sided|95.0|0.0025|0.0292||Statistical significance taken at the 0.05 level|GEE modeling|Reported P-value and estimate rely on the group x time interaction effect on primary outcome when controlling for subjective norms. Same method B&K|[Not specified]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for subjective norms as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.|
1593017|NCT03063385|2928532|Other|[Not specified]|Slope|0.0151|Standard Error of the Mean|0.0067||0.0249|2-Sided|95.0|0.0019|0.0282||Statistical significance taken at the 0.05 level|GEE modeling|P-value and estimate rely on group x time interaction effect on primary outcome when controlling for sexual communication attitudes. Same method B&K|[Not specified]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for sexual communication attitudes as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.|
1593018|NCT03063385|2928532|Other|[Not specified]|Slope|0.0153|Standard Error of the Mean|0.0067||0.0229|2-Sided|95.0|0.0022|0.0285||Statistical significance taken at the 0.05 level|GEE modeling|P-value & estimate rely on group x time interaction effect on primary outcome when controlling for self-efficacy. Used modified Baron & Kenny method|[Not specified]|The intervention effect of sexual risk communication (primary outcome in parents) controlling for self-efficacy as a mediator from baseline through 12 months was examined using longitudinal general estimating equations (GEE) modeling, with the Health promotion control condition as the reference category and adjusting for baseline sexual risk communication and average monthly income.|
1593019|NCT03063086|2928535|Superiority||Mean Difference (Final Values)|0.124|||<|0.0001|2-Sided|95.0|0.086|0.161|||Mixed Models Analysis||||
1593020|NCT03063086|2928540|Superiority||Median Difference (Final Values)|0.159|||<|0.0001|2-Sided|95.0|0.123|0.195|||Mixed Models Analysis||||
1593021|NCT03063086|2928540|Superiority||Mean Difference (Final Values)|0.172|||<|0.0001|2-Sided|95.0|0.137|0.208|||Mixed Models Analysis||||
1593022|NCT03062605|2928545|Other|Inequality test||||||0.13||||||Significant at p < 0.05|McNemar|||Lactobacillus, Baseline-12 Weeks|
1593023|NCT03062605|2928545|Other|Inequality test||||||0.09||||||Significant at p < 0.05|McNemar|||Lactobacillus, Baseline-12 Weeks|
1593024|NCT03062605|2928545|Other|Inequality test||||||0.29||||||Significant at p<0.05|McNemar|||Strep Mutans, Baseline-12 Weeks|
1593025|NCT03062605|2928545|Other|Inequality test||||||0.35||||||Significant at p < 0.05|McNemar|||Strep Mutans, Baseline-12 Weeks|
1593026|NCT03061331|2928559|Superiority||Least Squares Mean Difference|0.1||||0.9277|2-Sided|95.0|-2.5|2.7|||Mixed Model Repeated Measure (MMRM)||||
1593027|NCT03061214|2928640|Superiority|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was below 0%.|Treatment difference|-0.51|||<|0.0001|2-Sided|95.0|-0.66|-0.36|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.|
1593028|NCT03061214|2928640|Superiority|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was below 0%.|Treatment difference|-0.85|||<|0.0001|2-Sided|95.0|-1.0|-0.7|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.|
1593029|NCT03061214|2928640|Non-Inferiority|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was less than 0.3%.|Treatment difference|-0.51|||<|0.0001|2-Sided|95.0|-0.66|-0.36|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.|
1593114|NCT03056040|2928809|Non-Inferiority|NIM was based on the lower bound of the 95% CI. NIM was -20%.|Treatment Difference|1.4|||||2-Sided|95.0|-10.41|13.31|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants with stabilized hemoglobin was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug.|
1593030|NCT03061214|2928640|Non-Inferiority|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c between semaglutide and sitagliptin was less than 0.3%.|Treatment difference|-0.85|||<|0.0001|2-Sided|95.0|-1.0|-0.7|||Mixed Models Analysis|||The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and region China/Other as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution.|
1593031|NCT03060512|2928642|Other||LS Means difference|-0.9|Standard Error of the Mean|1.95|||2-Sided|95.0|-4.7|3.0||||||Analysis of Covariance (ANCOVA) model assessing treatment difference in BFI change from baseline at Visits 3/5 between Movantik and PEG 3350. Adjustments were performed for for baseline BFI score, treatment, period and sequence.|
1593032|NCT03060512|2928644|Other||Least Squares (LS) Means difference|0.0|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.3|0.3||||||Analysis of variance (ANOVA) model assessing treatment difference in PGIC at Visits 3 and 5 between Movantik and PEG 3350 treatment. Adjustments were performed for treatment, period and sequence.|
1593033|NCT03060512|2928647|Other|||||||0.8874|||||||Prescott's test|||Assessment of the difference between preference for treatment in Period 1, preference for treatment in Period 2, no preference|
1593034|NCT03060512|2928647|Other|||||||0.9239|||||||Prescott's test|||Assessment of the difference in preference for the two treatments (Prefer Movantik, No Preference, Prefer PEG 3350) in subjects who completed the entire treatment sequence.|
1593035|NCT03060486|2928649|Other||Signed Rank Score Difference|-60.0|||<|0.0001|2-Sided||||||Wilcoxon signed-rank test||||
1593036|NCT03059810|2928651|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE scores.|Mean Difference (Final Values)|0.7|Standard Deviation|2.63|||2-Sided|95.0|-4.6|5.9|||||Mean difference was calculated as Test (at 12-16 days follow up) – Habitual (at baseline)|It was a single arm study and the subjects’ overall vision was compared against the baseline with the habitual lens. Sample size was determined using Power procedure in SAS 9.4 using the input from historical data (alpha=0.05).|
1593037|NCT03058692|2928679|Other|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593038|NCT03058692|2928679|Other|||||||0.86||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593039|NCT03058692|2928680|Other|||||||0.66||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593040|NCT03058692|2928680|Other|||||||0.35||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593041|NCT03058692|2928681|Other|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593042|NCT03058692|2928681|Other|||||||0.65||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593043|NCT03058692|2928682|Other|||||||0.96||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593303|NCT03045861|2929269|Other||Emax|-1.846|||||2-Sided|95.0|-2.352|-1.34|||||||
1593304|NCT03045861|2929270|Other||s2e|0.206|||||2-Sided|95.0|0.097|0.314|||||||
1593305|NCT03045861|2929270|Other||ED50|55.572|||||2-Sided|95.0|3.565|107.579|||||||
1593044|NCT03058692|2928682|Other||||||<|0.001||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593045|NCT03058692|2928683|Other|||||||0.014||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593046|NCT03058692|2928683|Other|||||||0.44||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593047|NCT03058692|2928684|Other|||||||0.43||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593048|NCT03058692|2928684|Other|||||||0.54||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593049|NCT03058692|2928685|Other|||||||0.51||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593050|NCT03058692|2928685|Other|||||||0.0093||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593051|NCT03058692|2928686|Other|||||||0.62||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593052|NCT03058692|2928686|Other||||||<|0.001||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593053|NCT03058692|2928687|Other|||||||0.48||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593054|NCT03058692|2928687|Other|||||||0.67||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1608197|NCT02610868|2953671|Superiority||||||<|0.0001|||||||ANCOVA||||
1593055|NCT03058692|2928688|Other|||||||0.44||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593056|NCT03058692|2928688|Other|||||||0.16||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593057|NCT03058692|2928689|Other|||||||0.22||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593058|NCT03058692|2928689|Other|||||||0.31||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593059|NCT03058692|2928690|Other|||||||0.31||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593060|NCT03058692|2928690|Other|||||||0.72||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593061|NCT03058692|2928691|Other|||||||0.26||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593062|NCT03058692|2928691|Other|||||||0.14||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593063|NCT03058692|2928692|Other|||||||||||||||||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.
1593064|NCT03058692|2928692|Other|||||||0.94||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593065|NCT03058692|2928693|Other|||||||0.18||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593306|NCT03045861|2929270|Other||Emax|-1.801|||||2-Sided|95.0|-2.319|-1.283|||||||
1593307|NCT03045861|2929271|Other||s2e|0.2|||||2-Sided|95.0|0.095|0.306|||||||
1593066|NCT03058692|2928693|Other|||||||0.15||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593067|NCT03058692|2928694|Other|||||||0.62||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593068|NCT03058692|2928694|Other|||||||0.97||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593069|NCT03058692|2928695|Other|||||||0.56||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593070|NCT03058692|2928695|Other|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593071|NCT03058692|2928696|Other|||||||0.26||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593072|NCT03058692|2928696|Other|||||||0.42||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593073|NCT03058692|2928697|Other|||||||0.32||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593074|NCT03058692|2928697|Other|||||||0.36||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593075|NCT03058692|2928698|Other|||||||0.28||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593076|NCT03058692|2928698|Other|||||||0.0061||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1608198|NCT02610868|2953672|Superiority|||||||0.2569|||||||ANCOVA||||
1593077|NCT03058692|2928699|Other|||||||0.47||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593078|NCT03058692|2928699|Other|||||||0.81||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593079|NCT03058692|2928700|Other||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593080|NCT03058692|2928700|Other||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593081|NCT03058692|2928701|Other|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593082|NCT03058692|2928701|Other|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593083|NCT03058692|2928702|Other|||||||0.75||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593084|NCT03058692|2928702|Other||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593085|NCT03058692|2928703|Other|||||||0.076||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593086|NCT03058692|2928703|Other|||||||0.82||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593087|NCT03058692|2928704|Other|||||||0.57||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1608199|NCT02610868|2953672|Superiority|||||||0.0026|||||||ANCOVA||||
1593088|NCT03058692|2928704|Other|||||||0.87||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593089|NCT03058692|2928705|Other|||||||0.9||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593090|NCT03058692|2928705|Other|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593091|NCT03058692|2928706|Other|||||||0.74||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593092|NCT03058692|2928706|Other||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593093|NCT03058692|2928707|Other|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593094|NCT03058692|2928707|Other|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.
1593095|NCT03058692|2928708|Other|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.
1593096|NCT03058692|2928709|Other|||||||||||||||||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.
1593097|NCT03058692|2928709|Other|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.
1593098|NCT03058692|2928710|Other|||||||0.5||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593099|NCT03058692|2928710|Other|||||||||||||||||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|No non-zero results were reported for either group so statistical testing was not performed.
1593308|NCT03045861|2929271|Other||ED50|1020.755|||||2-Sided|95.0|100.786|1940.724|||||||
1593309|NCT03045861|2929271|Other||Emax|-1.822|||||2-Sided|95.0|-2.333|1.31|||||||
1608200|NCT02610868|2953672|Superiority|||||||0.1131|||||||ANCOVA||||
1593100|NCT03058692|2928711|Other|||||||0.94||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593101|NCT03058692|2928711|Other|||||||0.0078||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593102|NCT03058692|2928712|Other||||||>|0.99||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593103|NCT03058692|2928712|Other||||||>|0.32||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593104|NCT03058692|2928713|Other|||||||0.48||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593105|NCT03058692|2928713|Other|||||||0.66||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593106|NCT03058692|2928714|Other|||||||0.73||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593107|NCT03058692|2928714|Other|||||||0.74||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593108|NCT03058692|2928715|Other|||||||0.56||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD8+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593109|NCT03058692|2928715|Other|||||||0.53||||||As this trial was not confirmatory, as common for early phase trials, p-values were not adjusted for multiple comparisons, rather included to aid interpretation of the estimates. A priori threshold for statistical significance was not defined.|Wilcoxon (Mann-Whitney)|||This reports the analysis for response in CD4+ T cells at Day 36. The null hypothesis for the non-parametric test assumed both groups are from the same population, i.e., are homogeneous and have the same distribution. The study was not designed/powered to detect differences between groups in the frequencies of marker combinations, considering the issue of multiplicity.|
1593110|NCT03056456|2928758|Superiority|Day 3|Ratio of Geometric LS Means|1.04|||||2-Sided|90.0|0.82|1.32|||||||
1593111|NCT03056456|2928758|Superiority||Ratio of Geometric LS Means|1.03|||||2-Sided|90.0|0.808|1.31||||||Day 1|
1593112|NCT03056456|2928759|Superiority||Ratio of Geometric LS Means|1.01|||||2-Sided|90.0|0.817|1.25||||||Day 3|
1593113|NCT03056456|2928759|Superiority||Ratio of Geometric LS Means|1.0|||||2-Sided|90.0|0.81|1.23||||||Day 1|
1593356|NCT03041792|2929486|Superiority||Least Square Mean Difference|348.43|Standard Error of the Mean|138.29||0.0152|2-Sided|95.0|70.2|626.66|||Mixed Models Analysis|||AUC0-300min (Visit 5)|
1593115|NCT03056040|2928810|Non-Inferiority|NIM was based on the lower bound of the 95% CI. NIM was -20%.|Treatment Difference|5.5|||||2-Sided|95.0|-4.27|15.68|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants achieving transfusion avoidance was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug|
1593116|NCT03056040|2928811|Non-Inferiority|NIM was based on the lower bound of the 95% CI. NIM margin was -3.|Treatment Difference|1.47|||||2-Sided|95.0|-0.21|3.15|||||Treatment difference was estimated for ravulizumab - eculizumab.||
1593117|NCT03056040|2928812|Non-Inferiority|NIM was based on the upper bound of the 95% CI. NIM was 20%.|Treatment Difference|-5.1|||||2-Sided|95.0|-18.99|8.89|||||Treatment difference was estimated for ravulizumab - eculizumab.|A difference in the percentages of participants with BTH was calculated between the ravulizumab and eculizumab treatment groups, along with a 95% CI for the difference using the stratified Newcombe CI method. The stratification factor observed was transfusion history within 1 year prior to first dose of study drug.|
1593118|NCT03056040|2928813|Non-Inferiority|"A difference in percent change in LDH between the ravulizumab and eculizumab treatment groups at Day 183 along with a 2-sided 95% confidence interval (CI) was calculated.~Noninferiority margin (NIM) was based on the upper bound of the 95% CI. NIM was 15%."|Treatment Difference|-9.21|||||2-Sided|95.0|-18.84|0.42|||||Treatment difference was estimated for ravulizumab - eculizumab.|Adjusting for a possible 10% dropout rate, a minimum of 192 participants were estimated to provide 90% power to demonstrate noninferiority of ravulizumab to eculizumab.|
1593119|NCT03055988|2928814|Superiority||Adjusted mean difference|0.286|Standard Error of the Mean|0.057|<|0.0001|2-Sided|95.0|0.171|0.4|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 − F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.|
1593120|NCT03055988|2928815|Superiority||Adjusted mean difference|0.18|Standard Error of the Mean|0.029|<|0.0001|2-Sided|95.0|0.121|0.24|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 − F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.|
1593121|NCT03055988|2928816|Superiority||Adjusted mean difference|-7.957|Standard Error of the Mean|2.452||0.0019|2-Sided|95.0|-12.865|-3.05|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 − F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.|
1593122|NCT03055988|2928817|Superiority||Adjusted mean difference|-0.32|Standard Error of the Mean|1.509||0.833|2-Sided|95.0|-3.341|2.702|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 − F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.|
1593123|NCT03055988|2928818|Superiority||Adjusted mean difference|0.409|Standard Error of the Mean|1.335||0.7604|2-Sided|95.0|-2.264|3.082|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 − F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.|
1593124|NCT03055988|2928819|Superiority||Adjusted mean difference|2.069|Standard Error of the Mean|1.853||0.2687|2-Sided|95.0|-1.64|5.779|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 − F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.|
1593125|NCT03055988|2928820|Superiority||Adjusted mean difference|1.28|Standard Error of the Mean|1.995||0.5238|2-Sided|95.0|-2.719|5.279|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 − F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.|
1593126|NCT03055988|2928821|Superiority||Adjusted mean difference|0.001|Standard Error of the Mean|0.036||0.9817|2-Sided|95.0|-0.072|0.074|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 − F+S 1000/100).|MMRM model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation.|
1593127|NCT03055988|2928822|Superiority||Adjusted mean difference|-0.537|Standard Error of the Mean|1.12||0.6331|2-Sided|95.0|-2.779|1.705|||Mixed model repeated measures (MMRM)|Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean difference means the treatment difference vs. F+S (i.e. T+O 5/5 − F+S 1000/100).|Mixed model repeated measures (MMRM) model included treatment and period as fixed effects, patient as a random effect and baseline as covariate. Unstructured covariance structure was used for within patient variation. H0: Mean change from baseline in LVEDVI for (Tiotropium + Olodaterol) = Mean change from baseline in LVEDVI for (Fluticasone propionate + Salmeterol)|
1593128|NCT03055832|2928828|Non-Inferiority|A standard deviation of 14 was assumed based on pilot data and the non-inferiority delta was set to 7. The chosen sample size and alpha = 0.025 provides 80% power for this endpoint|Mean Difference (Net)|-3.08|Standard Error of the Mean|2.89|||2-Sided|95.0|-8.75|2.59||||||All questions|
1593129|NCT03055832|2928829|Other|A formal hypothesis was not proposed for this endpoint and therefore a power calculation was not performed. A Fisher's Exact test was performed post hoc to determine if a significant difference existed between the two arms.||||||0.12|||||||Fisher Exact||||
1593130|NCT03055832|2928830|Non-Inferiority|"This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:~MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%~TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%~Power that both endpoitns are significant, assuming independence was 0.939^2 = 0.882 or 88.2% power."|Mean Difference (Net)|0.1|Standard Error of the Mean|0.54|||2-Sided|95.0|-0.97|1.16|||||||
1593131|NCT03055832|2928831|Non-Inferiority|"This study provides a combined power of co-primary endpoints of 88% given the following primary endpoint assumptions:~MGS non-inferiority delta of 5 points and standard deviation of 8 points provides power of 93.9%~TBT non-inferiority delta of 2.5 seconds and standard deviation of 4 seconds, provides a TBT primary endpoint power of 93.9%~Power that both endpoitns are significant, assuming independence was 0.939^2 = 0.882 or 88.2% power."|Mean Difference (Net)|-0.13|Standard Error of the Mean|1.88|||2-Sided|95.0|-3.82|3.56|||||||
1593132|NCT03055494|2928857|Other|Statistical hypothesis tests were not performed in this study|difference in percentages|55.8|||||2-Sided|95.0|42.3|69.3|||||||
1593133|NCT03055494|2928858|Other|Statistical hypothesis tests were not performed in this study|difference in percentages|76.1|||||2-Sided|95.0|63.3|88.8|||||||A patient with missing assessment was considered as having a “yes” response of skin histology/K16 expression to treatment regardless of the reason for missing data (eg, premature study discontinuation, missed visit, administrative issues). However, missing baseline value was not imputed.
1593134|NCT03055338|2928859|Other||Difference in LSM|-0.4|||||2-Sided|95.0|-0.8|0.1|||||Difference in LSM = Risperidone - Placebo||
1593135|NCT03055338|2928859|Other||Difference in LSM|-0.2|||||2-Sided|95.0|-0.5|0.2|||||Difference in LSM = MK-8189 - Placebo||
1593136|NCT03055338|2928859|Other||Difference in LSM|0.2|||||2-Sided|95.0|-0.2|0.6|||||Difference in LSM = MK-8189 - Risperidone||
1593137|NCT03055338|2928860|Other||Difference in % versus Placebo|-1.2|||||2-Sided|95.0|-9.6|7.0|||||Difference in % = MK-8918 - Placebo||Based on Miettinen & Nurminen method.
1593138|NCT03055338|2928861|Other||Difference in % versus Placebo|17.2|||||2-Sided|95.0|3.0|30.8|||||Difference in % = MK-8918 - Placebo||Based on Miettinen & Nurminen method.
1593139|NCT03055338|2928862|Superiority||Difference in LSM|-7.3||||0.033|2-Sided|95.0|-14.0|-0.6|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = Risperidone - Placebo||
1593140|NCT03055338|2928862|Superiority||Difference in LSM|-4.7||||0.074|2-Sided|95.0|-9.8|0.5|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = MK-8189 - Placebo||
1593141|NCT03055338|2928862|Superiority||Difference in LSM|2.6||||0.44|2-Sided|95.0|-4.0|9.2|||Longitudinal ANCOVA|Includes terms for treatment, baseline PANSS total score, age, duration of illness, week, and the interaction of week by treatment.|Difference in LSM = MK-8189 - Risperidone||
1593142|NCT03055195|2928888|Other||Proportion Difference|6.0|||||2-Sided|90.0|-3.3|14.4|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 20 has been presented.||
1593143|NCT03055195|2928888|Other||Proportion Difference|11.0|||||2-Sided|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 16 has been presented.||
1593144|NCT03055195|2928888|Other||Proportion Difference|11.0|||||2-Sided|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 12 has been presented.||
1593145|NCT03055195|2928888|Other||Proportion Difference|11.0|||||2-Sided|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 8 has been presented.||
1593146|NCT03055195|2928888|Other||Proportion Difference|-1.0|||||2-Sided|90.0|-14.0|12.6|||||Difference in Proportions between Mepolizumab 100 mg SC Versus Placebo SC at Week 4 has been presented.||
1593147|NCT03055195|2928890|Other||Proportions Difference|11.0|||||2-Sided|90.0|-1.1|23.3|||||Difference in Proportions between Mepolizumab 100 mg SC versus Placebo SC has been presented.||
1593148|NCT03054857|2928896|Superiority||Mean Difference (Final Values)|-4.644|Standard Deviation|7.606||0.543|2-Sided|95.0|-19.74|10.45|||t-test, 2 sided||||
1593149|NCT03054857|2928897|Superiority||Mean Difference (Final Values)|-1.053|Standard Deviation|0.792||0.187|2-Sided|95.0|-2.626|0.52|||t-test, 2 sided||||
1593150|NCT03054857|2928899|Superiority||Risk Ratio (RR)|1.329||||0.636|2-Sided|95.0|0.409|4.319|||Chi-squared||||
1593151|NCT03054857|2928900|Superiority||Risk Ratio (RR)|1.532||||0.289|2-Sided|95.0|0.689|3.406|||Chi-squared||||
1593152|NCT03054740|2928911|Superiority|||||||0.39|||||||Fisher Exact||||
1593153|NCT03054740|2928912|Superiority||||||||||||||||||Levene's Test of Equality of Error Variances (Design: Intercept + Pain Previous IV + Intervention) F = .001, df1 = 1, df2=28, Sig. = .972
1593154|NCT03054428|2928939|Superiority||Percentage difference|21.7|||=|0|2-Sided|95.0|11.21|32.28||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity [IGA=3 vs IGA=4] and baseline weight group [<60 kg vs ≥60 kg].|
1593155|NCT03054428|2928939|Superiority||Percentage difference|31.8|||<|0.0001|2-Sided|95.0|20.45|43.2||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity [IGA=3 vs IGA=4] and baseline weight group [<60 kg vs ≥60 kg].|
1593156|NCT03054428|2928940|Superiority||percentage difference|29.1|||<|0.0001|2-Sided|95.0|16.97|41.32||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity [IGA=3 vs IGA=4] and baseline weight group [<60 kg vs ≥60 kg].|
1593357|NCT03041792|2929486|Superiority||Least Square Mean Difference|214.24|Standard Error of the Mean|129.48||0.104|2-Sided|95.0|-45.59|474.07|||Mixed Models Analysis|||AUC0-300min (Visit 4)|
1593157|NCT03054428|2928940|Superiority||percentage difference|39.4|||<|0.0001|2-Sided|95.0|26.9|51.84||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Difference is Dupilumab minus Placebo. C.I. = Confidence interval calculated using normal approximation. P-values were derived by CMH test stratified by baseline disease severity [IGA=3 vs IGA=4] and baseline weight group [<60 kg vs ≥60 kg].|
1593158|NCT03054428|2928941|Superiority||LS Mean difference|-26.5|||<|0.0001|2-Sided|95.0|-37.45|15.63||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity [IGA=3 vs IGA=4] and baseline weight group [<60 kg vs ≥60 kg]) as fixed factors.|
1593159|NCT03054428|2928941|Superiority||LS Mean difference|-29.0|||<|0.0001|2-Sided|95.0|-39.54|-18.38||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity [IGA=3 vs IGA=4] and baseline weight group [<60 kg vs ≥60 kg]) as fixed factors.|
1593160|NCT03054428|2928942|Superiority||LS Mean difference|-41.2|||<|0.0001|2-Sided|95.0|-54.44|-28.02||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using ANCOVA model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity [IGA=3 vs IGA=4] and baseline weight group [<60 kg vs ≥60 kg]) as fixed factors.|
1593161|NCT03054428|2928942|Superiority||Least Square (LS) Mean difference|-42.3|||<|0.0001|2-Sided|95.0|-55.6|-29.04||Threshold for significance at 0.05 level.|ANCOVA|||A hierarchical testing procedure was used to control type I error. The confidence interval (CI) with p-value is based on treatment difference (Dupilumab group vs. Placebo) of the LS mean percent change using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment, randomization strata (baseline disease severity [IGA=3 vs IGA=4] and baseline weight group [<60 kg vs ≥60 kg]) as fixed factors.|
1593162|NCT03054428|2928943|Superiority||percentage difference|29.9|||<|0.0001|2-Sided|95.0|17.94|41.78||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (<60 kg vs ≥60 kg).|
1593163|NCT03054428|2928943|Superiority||percentage difference|33.2|||<|0.0001|2-Sided|95.0|21.07|45.39||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (<60 kg vs ≥60 kg).|
1593164|NCT03054428|2928944|Superiority||percentage difference|15.5|||=|0|2-Sided|95.0|6.7|24.31||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using CMH test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (<60 kg vs ≥60 kg).|
1593165|NCT03054428|2928944|Superiority||percentage difference|22.0|||<|0.0001|2-Sided|95.0|12.2|31.87||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error. Analysis was performed using Cochran-Mantel-Haenszel (CMH) test stratified by baseline disease severity (IGA=3 vs IGA=4) and baseline weight group (less than [<] 60 kilogram [kg] vs greater than or equal to [≥] 60 kg).|
1593166|NCT03053427|2928975|Superiority||LSM difference|0.0|Standard Error of the Mean|0.2||0.838|2-Sided|95.0|-0.4|0.3|||ANCOVA|||LSM difference (gabapentin enacarbil group minus placebo group) of the changes in RLS pain score from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.|
1593167|NCT03053427|2928976|Superiority||LSM difference|0.0|Standard Error of the Mean|0.3||0.975|2-Sided|95.0|-0.7|0.7|||ANCOVA|||LSM difference (gabapentin enacarbil group minus placebo group) of the changes in total score of Athens insomnia scale from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.|
1593168|NCT03053427|2928977|Superiority||LSM difference|0.0|Standard Error of the Mean|0.3||0.877|2-Sided|95.0|-0.5|0.5|||ANCOVA|||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in PSQI component and global scores from baseline was calculated by visit, using the ANCOVA model with the baseline value as a covariate.|
1593169|NCT03053427|2928978|Superiority||difference|5.8||||0.3|2-Sided|95.0|-4.8|16.5|||Fisher Exact||||
1593170|NCT03053427|2928979|Superiority||difference|4.2||||0.467|2-Sided|95.0|-6.4|14.8|||Fisher Exact||||
1593171|NCT03053427|2928980|Superiority||LSM difference|-0.8|Standard Error of the Mean|0.8||0.312|2-Sided|95.0|-2.4|0.8|||ANCOVA|Time frame: EoT||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.|
1593172|NCT03053427|2928980|Superiority||LSM difference|-1.4|Standard Error of the Mean|0.8||0.087|2-Sided|95.0|-3.0|0.2|||ANCOVA|Time frame: week 12||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.|
1593173|NCT03053427|2928980|Superiority||LSM difference|-1.7|Standard Error of the Mean|0.7||0.027|2-Sided|95.0|-3.1|-0.2|||ANCOVA|Time frame: week 10||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.|
1593174|NCT03053427|2928980|Superiority||LSM difference|-1.0|Standard Error of the Mean|0.7||0.184|2-Sided|95.0|-2.4|0.5|||ANCOVA|Time frame: week 8||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.|
1593175|NCT03053427|2928980|Superiority||LSM difference|-1.5|Standard Error of the Mean|0.7||0.043|2-Sided|95.0|-2.9|0.0|||ANCOVA|Time frame: week 6||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.|
1593176|NCT03053427|2928980|Superiority||LSM difference|-1.5|Standard Error of the Mean|0.7||0.028|2-Sided|95.0|-2.9|-0.2|||ANCOVA|Time frame: week 4||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.|
1593177|NCT03053427|2928980|Superiority||LSM difference|-1.5|Standard Error of the Mean|0.7||0.02|2-Sided|95.0|-2.8|-0.2|||ANCOVA|Time frame: week 2||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.|
1593178|NCT03053427|2928980|Superiority||LSM difference|-1.1|Standard Error of the Mean|0.6||0.051|2-Sided|95.0|-2.2|0.0|||ANCOVA|Time frame: week 1||LMS difference (gabapentin enacarbil group minus placebo group) of the changes in IRLS score from baseline was calculated by visit, using ANCOVA model with the baseline value as a covariate.|
1593179|NCT03053427|2928981|Superiority||LSM difference|-1.2|Standard Error of the Mean|0.7||0.088|2-Sided|95.0|-2.6|0.2|||Mixed Model of Repeated Measurements|||MMRM with compound symmetry as the covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point.|
1593180|NCT03053063|2928989|Superiority||Percentage Difference|-0.4||||0.8557|2-Sided|95.0|-4.3|3.6||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (<11.27 vs ≥11.27).|Mantel Haenszel||||
1593181|NCT03053063|2928989|Superiority||Percentage Difference|-1.7||||0.365|2-Sided|95.0|-5.5|2.0||Difference between SEL 18 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (<11.27 vs ≥11.27).|Mantel Haenszel||||
1593182|NCT03053063|2928991|Superiority||Percentage Difference|1.5||||0.6731|2-Sided|95.0|-5.3|8.2||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (<11.27 vs ≥11.27).|Mantel Haenszel||||
1593183|NCT03053063|2928991|Superiority||Percentage Difference|3.8||||0.285|2-Sided|95.0|-3.1|10.6||Difference between SEL 18 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (<11.27 vs ≥11.27).|Mantel Haenszel||||
1593184|NCT03053063|2928994|Superiority||Percentage Difference|0.3||||0.9272|2-Sided|95.0|-6.0|6.5||Difference between SEL 6 mg vs Placebo, 95% CI and p-value were obtained by stratified Mantel-Haenszel method adjusting for BL diabetes mellitus status and BL ELF score (<11.27 vs ≥11.27).|Mantel Haenszel||||
1593185|NCT03053063|2928994|Superiority||Percentage Difference|1.9||||0.5572|2-Sided|95.0|-4.4|8.2||Difference between SEL 18 mg vs Placebo, 95% confidence interval (CI) and p-value were obtained by stratified Mantel-Haenszel method adjusting for baseline (BL) diabetes mellitus status and BL Enhanced Liver Fibrosis (ELF) score (<11.27 vs ≥11.27).|Mantel Haenszel||||
1593186|NCT03052764|2928995|Superiority||Odds Ratio (OR)|13.03|||||2-Sided|95.0|3.23|52.57|||||Values were obtained from a Cochran Mantel-Haenszel test adjusting for the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes) at each scheduled visit.||
1593187|NCT03052764|2928996|Superiority||Least Squares Mean Difference|-0.71|Standard Error of the Mean|0.192||0.0004|2-Sided|95.0|-1.09|-0.32|||ANCOVA||||
1593188|NCT03052764|2928997|Superiority||Least Squares Mean Difference|-2.56|Standard Error of the Mean|0.59|<|0.0001|2-Sided|95.0|-3.73|-1.39|||ANCOVA||||
1593189|NCT03052764|2928998|Superiority||Least Squares Mean Difference|-2.24|Standard Error of the Mean|0.534|<|0.0001|2-Sided|95.0|-3.3|-1.18|||ANCOVA||||
1593190|NCT03052764|2928999|Superiority||Odds Ratio (OR)|6.15|||||2-Sided|95.0|0.75|50.37|||||Values obtained were from a Cochran Mantel-Haenszel test adjusting for the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes)at each scheduled visit.||
1593191|NCT03052764|2929000|Superiority||Least Squares Mean Difference|-2.57|Standard Error of the Mean|0.561|<|0.0001|2-Sided|95.0|-3.68|-1.46|||ANCOVA||||
1593192|NCT03052426|2929022|Superiority||||||<|0.0001||||||Interference (F-test G-G Epsilon (1.55, 18.66) = 34.09, p < 0.0001), from time 1 to times 2 and 3.|MANOVA|||We used repeated measures MANOVAs with pairwise comparisons to examine the decrease of the variables over time. Significant differences for within subjects by time were found|
1593193|NCT03052426|2929022|Superiority||||||=|0||||||Uncomfortable (F-test G-G Epsilon (1.43, 17.15) = 14.39, p = 0.0006), from time 1 to times 2 and 3|MANOVA|||Three and six month results were combined and compared to baseline data for each of the outcome variables. Repeated measures MANOVAs with pairwise comparisons were used to examine the decrease of variables over time from time 1 to times 2 and 3.|
1593194|NCT03052426|2929022|Superiority||||||<|0.0001||||||Aches (F-test G-G Epsilon (1.26, 15.18) = 34.70, p < 0.0001)|MANOVA|||Three and six month results were combined and compared to baseline data for each of the outcome variables. Repeated measures MANOVAs with pairwise comparisons were used to examine the decrease of variables over time from time 1 to times 2 and 3.|
1593195|NCT03052426|2929023|Superiority|||||||0.4495||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 1.5991, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for interference at the six month time frame|
1593196|NCT03052426|2929023|Superiority|||||||0.2595||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 2.6983, DF||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for discomfort at the six month time frame.|
1593197|NCT03052426|2929023|Superiority|||||||0.6316||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 0.9190, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSquare Analysis were completed|
1593198|NCT03052426|2929024|Superiority|||||||0.9196||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 0.1676, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for interference at the three month time frame.|
1593199|NCT03052426|2929024|Superiority|||||||0.7523||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSquare 0.5693, DF 2||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for discomfort at the three month time frame|
1593200|NCT03052426|2929024|Superiority|||||||0.9327||||||p=0.05 is the threshold for statistical significance|Chi-squared|ChiSqaure 0.1394, DF 2 for aches||Wilcoxon/Kruskal-Wallis Tests and ChiSqaure analysis were completed for aches/pains at the three month time frame|
1593201|NCT03051217|2929056|Superiority||Adjusted Mean Treatment Difference|-4.2|||<|0.0001|2-Sided|95.0|-5.295|-3.069||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593202|NCT03051217|2929056|Superiority||Adjusted Mean Treatment Difference|-3.1|||<|0.0001|2-Sided|95.0|-4.265|-2.002||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline Itch NRS with treatment group and prior biologic exposure as factors and Baseline Itch NRS as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593203|NCT03051217|2929057|Superiority||Adjusted Mean Treatment Difference|-6.5|||<|0.0001|2-Sided|97.5|-9.099|-3.91||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group and prior biologic exposure as factors and Baseline DLQI score as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593204|NCT03051217|2929057|Superiority||Adjusted Mean Treatment Difference|-6.5|||<|0.0001|2-Sided|97.5|-9.1|-3.844||p-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group and prior biologic exposure as factors and Baseline DLQI score as a covariate.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593205|NCT03051217|2929058|Superiority||Odds Ratio (OR)|100.459|||<|0.0001|2-Sided|97.5|15.54|649.437||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593206|NCT03051217|2929058|Superiority||Odds Ratio (OR)|38.696|||<|0.0001|2-Sided|97.5|6.047|247.634||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593207|NCT03051217|2929058|Superiority||Estimated difference in responder rate|75.5|||<||2-Sided|95.0|51.95|99.04|||||If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593208|NCT03051217|2929058|Superiority||Estimated difference in responder rate|53.6|||<||2-Sided|95.0|30.67|76.47|||||If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593209|NCT03051217|2929059|Superiority||Odds Ratio (OR)|69.58|||<|0.0001|2-Sided|97.5|11.138|434.659||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593210|NCT03051217|2929059|Superiority||Odds Ratio (OR)|38.193|||<|0.0001|2-Sided|97.5|6.113|238.619||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593211|NCT03051217|2929059|Superiority||Estimated difference in responder rate|66.7|||<||2-Sided|95.0|43.34|90.15|||||If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593212|NCT03051217|2929059|Superiority||Estimated difference in responder rate|52.7|||<||2-Sided|95.0|29.95|75.39|||||If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593213|NCT03051217|2929060|Superiority||Odds Ratio (OR)|79.112|||<|0.0001|2-Sided|97.5|11.739|533.168||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593214|NCT03051217|2929060|Superiority||Odds Ratio (OR)|31.695|||<|0.0001|2-Sided|97.5|5.129|195.877||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.||The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593215|NCT03051217|2929060|Superiority||Estimated difference in responder rate|79.1|||<||2-Sided|95.0|65.1|93.17|||||If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593747|NCT03028142|2930109|Other||LS Means ratio|1.06||||0.0009|2-Sided|95.0|1.02|1.09|||ANCOVA||||
1593216|NCT03051217|2929060|Superiority||Estimated difference in responder rate|65.1|||<||2-Sided|95.0|48.22|81.9|||||If there is a group without a responder, in this case the biological exposure will be excluded from the model, an exact logistic regression applied.|The primary and secondary efficacy endpoints were evaluated using a fixed-sequence testing procedure to account for multiplicity.|
1593217|NCT03051100|2929070|Superiority||||||<|0.001|||||||Fisher Exact||||
1593218|NCT03051100|2929071|Superiority||||||<|0.001|||||||Fisher Exact||||
1593219|NCT03051100|2929072|Superiority||Median treatment difference|-41.9|Standard Error of the Mean|9.86|<|0.001|2-Sided|95.0|-60.0|-21.4|||Wilcoxon rank sum test||||
1593220|NCT03051100|2929073|Superiority||Least squares mean difference|-1.5|Standard Error of the Mean|2.7|=|0|2-Sided|95.0|-7.0|4.0|||ANCOVA|||HDL-C|
1593221|NCT03051100|2929073|Superiority||Least squares mean difference|-36.3|Standard Error of the Mean|6.58|<|0.001|2-Sided|95.0|-49.7|-22.8|||ANCOVA|||TG|
1593222|NCT03051100|2929073|Superiority||Least squares mean difference|-54.1|Standard Error of the Mean|2.74|<|0.001|2-Sided|95.0|-59.7|-48.6|||ANCOVA|||apoB|
1593223|NCT03051100|2929073|Superiority||Least squares mean difference|-46.0|Standard Error of the Mean|2.77|<|0.001|2-Sided|95.0|-51.6|-40.4|||ANCOVA||Triplet therapy minus placebo|TC|
1593224|NCT03051100|2929073|Superiority||Least squares mean difference|-58.7|Standard Error of the Mean|3.02|<|0.001|2-Sided|95.0|-64.9|-52.6|||ANCOVA||Triplet therapy minus placebo|non-HDL-C|
1593225|NCT03051100|2929074|Superiority||Least squares mean difference|-60.5|Standard Error of the Mean|3.67|<|0.001|2-Sided|95.0|-68.0|-53.0|||ANCOVA||Triplet therapy minus placebo||
1593226|NCT03050918|2929075|Superiority|||||||0.05||||||We used the O’Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared||||
1593227|NCT03050918|2929077|Superiority|||||||0.05||||||We used the O’Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared||||
1593228|NCT03050918|2929078|Superiority|||||||0.05||||||We used the O’Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)||||
1593229|NCT03050918|2929079|Superiority|||||||0.05||||||We used the O’Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared||||
1593230|NCT03050918|2929080|Superiority|||||||0.05||||||We used the O’Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared||||
1593231|NCT03050918|2929080|Superiority|||||||0.05||||||We used the O’Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared||||
1593232|NCT03050918|2929081|Superiority|||||||0.05||||||We used the O’Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)||||
1593233|NCT03050918|2929081|Superiority|||||||0.05||||||We used the O’Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Chi-squared||||
1593234|NCT03050918|2929082|Superiority|||||||0.05||||||we used the O’Brian-Fleming α-spending function, allowing for an α-level of significance of 0.005 and 0.048 for the interim and final analyses, respectively.|Wilcoxon (Mann-Whitney)||||
1593235|NCT03050775|2929083|Superiority||Median Difference (Final Values)|75.0||||0.404|2-Sided|95.0|-100.0|250.0|||Wilcoxon (Mann-Whitney)||||
1593236|NCT03050775|2929084|Superiority||Odds Ratio (OR)|1.4||||0.619|2-Sided|95.0|0.5|3.7|||Fisher Exact||||
1593237|NCT03050775|2929085|Superiority||Mean Difference (Final Values)|-0.1||||0.571|2-Sided|95.0|-0.2|0.1|||t-test, 2 sided|||Data was obtained from 32 subjects in the treatment group.|
1593238|NCT03050775|2929086|Superiority||Median Difference (Final Values)|0.0||||0.672|2-Sided|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)||||
1593239|NCT03050775|2929087|Superiority||Odds Ratio (OR)|1.7||||0.54|2-Sided|95.0|0.5|5.9|||Fisher Exact|||Post-operative shivering observed|
1593240|NCT03050775|2929088|Superiority||Median Difference (Final Values)|0.0||||0.986|2-Sided|95.0|-0.2|0.2|||t-test, 2 sided|||~120 minutes post-induction|
1593241|NCT03050775|2929088|Superiority||Median Difference (Final Values)|0.0||||0.853|2-Sided|95.0|-0.2|0.3|||t-test, 2 sided|||~60 minutes post-induction. Data was obtained from 33 subjects in the treatment group.|
1593242|NCT03050775|2929088|Superiority||Mean Difference (Final Values)|0.0||||0.823|2-Sided|95.0|-0.3|0.2|||t-test, 2 sided|||~30 minutes post-induction|
1593243|NCT03050775|2929089|Superiority||Mean Difference (Final Values)|0.076||||0.358|2-Sided|95.0|-0.085|0.237|||ANCOVA||||
1593244|NCT03050775|2929089|Superiority|||||||0.807|||||||t-test, 2 sided||||
1593245|NCT03050372|2929115|Equivalence|Significance level alpha=0.05; CI=95%||||||0.114|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Sham LFMS is equal 0 Ha: Mean is not equal zero"|
1593246|NCT03050372|2929115|Equivalence|Significance level alpha=0.05; CI=95%||||||0.249|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Concentration for Active LFMS is equal 0 Ha: Mean is not equal zero"|
1593247|NCT03050372|2929115|Equivalence|Significance level alpha=0.05; CI=95%||||||0.13|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Concentration for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Concentration for active/sham LFMS are equal Ha: Means differ"|
1593358|NCT03041792|2929486|Superiority||Least Square Mean Difference|106.15|Standard Error of the Mean|48.95||0.0348|2-Sided|95.0|7.86|204.44|||Mixed Models Analysis|||AUC0-60min (Visit 5)|
1593748|NCT03028142|2930109|Other||LS Means ratio|1.03||||0.0988|2-Sided|95.0|0.99|1.06|||ANCOVA||||
1593248|NCT03050372|2929116|Equivalence|Significance level alpha=0.05; CI=95%||||||0.117|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Sham LFMS is equal 0 Ha: Mean is not equal zero"|
1593249|NCT03050372|2929116|Equivalence|Significance level alpha=0.05; CI=95%||||||0.156|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline Fatigue for Active LFMS is equal 0 Ha: Mean is not equal zero"|
1593250|NCT03050372|2929116|Equivalence|Significance level alpha=0.05; CI=95%||||||0.226|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of Fatigue for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline Fatigue for active/sham LFMS are equal Ha: Means differ"|
1593251|NCT03050372|2929117|Equivalence|Significance level alpha=0.05; CI=95%||||||0.284|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Sham LFMS is equal 0 Ha: Mean is not equal zero"|
1593252|NCT03050372|2929117|Equivalence|Significance level alpha=0.05; CI=95%||||||0.379|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline #awake for Active LFMS is equal 0 Ha: Mean is not equal zero"|
1593253|NCT03050372|2929117|Equivalence|Significance level alpha=0.05; CI=95%||||||0.05|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of #awake for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline #awake for active/sham LFMS are equal Ha: Means differ"|
1593254|NCT03050372|2929118|Equivalence|Significance level alpha=0.05; CI=95%||||||0.042|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Sham LFMS is equal 0 Ha: Mean is not equal zero"|
1593255|NCT03050372|2929118|Equivalence|Significance level alpha=0.05; CI=95%||||||0.004|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SQS for Active LFMS is equal 0 Ha: Mean is not equal zero"|
1593256|NCT03050372|2929118|Equivalence|Significance level alpha=0.05; CI=95%||||||1|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SQS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SQS for active/sham LFMS are equal Ha: Means differ"|
1593257|NCT03050372|2929119|Equivalence|Significance level alpha=0.05; CI=95%||||||0.092|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Sham LFMS is equal 0 Ha: Mean is not equal zero"|
1593258|NCT03050372|2929119|Equivalence|Significance level alpha=0.05; CI=95%||||||0.196|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline EOS for Active LFMS is equal 0 Ha: Mean is not equal zero"|
1593259|NCT03050372|2929119|Equivalence|Significance level alpha=0.05; CI=95%||||||0.535|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of EOS for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline EOS for active/sham LFMS are equal Ha: Means differ"|
1593260|NCT03050372|2929120|Equivalence|Significance level alpha=0.05; CI=95%||||||0.19|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Sham LFMS is equal 0 Ha: Mean is not equal zero"|
1593261|NCT03050372|2929120|Equivalence|Significance level alpha=0.05; CI=95%||||||0.21|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SE for Active LFMS is equal 0 Ha: Mean is not equal zero"|
1593262|NCT03050372|2929120|Equivalence|Significance level alpha=0.05; CI=95%||||||0.424|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SE for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SE for active/sham LFMS are equal Ha: Means differ"|
1593263|NCT03050372|2929121|Equivalence|Significance level alpha=0.05; CI=95%||||||0.298|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Sham LFMS is equal 0 Ha: Mean is not equal zero"|
1593264|NCT03050372|2929121|Equivalence|Significance level alpha=0.05; CI=95%||||||0.586|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline TST for Active LFMS is equal 0 Ha: Mean is not equal zero"|
1593265|NCT03050372|2929121|Equivalence|Significance level alpha=0.05; CI=95%||||||0.197|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of TST for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline TST for active/sham LFMS are equal Ha: Means differ"|
1593359|NCT03041792|2929486|Superiority||Least Square Mean Difference|35.56|Standard Error of the Mean|52.46||0.5008|2-Sided|95.0|-69.64|140.76|||Mixed Models Analysis|||AUC0-60min (Visit 4)|
1608201|NCT02610868|2953672|Superiority||||||<|0.0001|||||||ANCOVA||||
1593266|NCT03050372|2929122|Equivalence|Significance level alpha=0.05; CI=95%||||||0.221|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Sham LFMS is equal 0 Ha: Mean is not equal zero"|
1593267|NCT03050372|2929122|Equivalence|Significance level alpha=0.05; CI=95%||||||0.08|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline WASO for Active LFMS is equal 0 Ha: Mean is not equal zero"|
1593268|NCT03050372|2929122|Equivalence|Significance level alpha=0.05; CI=95%||||||0.925|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of WASO for active/sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline WASO for active/sham LFMS are equal Ha: Means differ"|
1593269|NCT03050372|2929123|Equivalence|Significance level alpha=0.05; CI=95%||||||0.687|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Sham LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Sham LFMS is equal 0 Ha: Mean is not equal zero"|
1593270|NCT03050372|2929123|Equivalence|Significance level alpha=0.05; CI=95%||||||0.321|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for Baseline and Active LFMS are equal Ha: Means differ~Note this paired t-test is equivalent to a one-sample t-test:~H0: Mean changes from Baseline SOL for Active LFMS is equal 0 Ha: Mean is not equal zero"|
1593271|NCT03050372|2929123|Equivalence|Significance level alpha=0.05; CI=95%.||||||0.329|||||||t-test, 2 sided|||"This is a crossover study; we use a paired t-test to test the hypothesis:~H0: Means of SOL for active/sham LFMS are equal; Ha: Means differ~Note this paired t-test is equivalent to:~H0: Mean changes from Baseline SOL for active/sham LFMS are equal Ha: Means differ"|
1593272|NCT03049852|2929152|Superiority||Mean Difference (Final Values)|0.27||||0.007|2-Sided||||||ANOVA||||
1593273|NCT03049852|2929154|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1593274|NCT03049748|2929155|Other|||||||0.05||||||Differences in group hospitalization rates p-values: T1 = .093; T2 = .008; T3 = .029|Wilcoxon (Mann-Whitney)||||
1593275|NCT03049748|2929156|Other||||||>|0.05||||||All p-values between group differences across time periods were > .05|Wilcoxon (Mann-Whitney)||||
1593276|NCT03049748|2929157|Other||||||>|0.05||||||All p-values between groups across time periods were >.05|Wilcoxon (Mann-Whitney)||||
1593277|NCT03049748|2929158|Other||||||>|0.05||||||All p values between groups across time periods were > .05|Wilcoxon (Mann-Whitney)||||
1593278|NCT03049748|2929159|Other|Same rationale as the primary outcome.|||||>|0.05||||||All p-values across time periods, between groups, were > .05|Wilcoxon (Mann-Whitney)||||
1593279|NCT03049748|2929160|Other|This is a pilot randomized trial with a purpose of establishing preliminary efficacy data to inform future studies.|||||>|0.05||||||p-values of all time periods (T0, T1, T2, T3) between group were > .05|Wilcoxon (Mann-Whitney)||||
1593280|NCT03047447|2929181|Other|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with blood ketones for experimental ketogenic group vs.control exercise and non-exercise groups.|||
1593281|NCT03047447|2929182|Other|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with body fat mass for experimental ketogenic group vs.control exercise and non-exercise groups.|||
1593282|NCT03047447|2929183|Other|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with BMI for experimental ketogenic group vs.control exercise and non-exercise groups.|||
1593283|NCT03047447|2929184|Other|||||||0.001|||||||ANOVA|Change over time from week 0 to week 10 with weight for experimental ketogenic group vs.control exercise and non-exercise groups.|||
1593284|NCT03047447|2929185|Other|||||||0.001||||||Change over time from week 0 to week 10 with HgA1c for experimental ketogenic group vs.control exercise and non-exercise groups.|ANOVA||||
1593285|NCT03046472|2929198|Other|||||||0.01|||||||t-test, 2 sided||||
1593286|NCT03046472|2929199|Other||||||<|0.001|||||||ANOVA||||
1593287|NCT03046472|2929200|Other||||||<|0.001|||||||ANOVA||||
1593288|NCT03045887|2929230|Other||Ratio|2.06|Standard Error of the Mean|0.128|||2-Sided|90.0|1.67|2.55|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Ctau is presented.||
1593289|NCT03045887|2929236|Other||ratio|1.14|Standard Error of the Mean|0.104|||2-Sided|90.0|0.96|1.36|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for Cmax is presented||
1593290|NCT03045887|2929237|Other||ratio|0.76|Standard Error of the Mean|0.106|||2-Sided|90.0|0.63|0.9|||||||
1593291|NCT03045887|2929237|Other||ratio|0.66|Standard Error of the Mean|0.154|||2-Sided|90.0|0.51|0.86|||||||
1593292|NCT03045887|2929237|Other||ratio|0.81|Standard Error of the Mean|0.106|||2-Sided|90.0|0.68|0.97|||||||
1593293|NCT03045887|2929237|Other||ratio|0.96|Standard Error of the Mean|0.145|||2-Sided|90.0|0.75|1.22|||||||
1593294|NCT03045887|2929237|Other||ratio|0.78|Standard Error of the Mean|0.145|||2-Sided|90.0|0.61|0.99|||||||
1593295|NCT03045887|2929238|Other||Ratio|1.22|Standard Error of the Mean|0.098|||2-Sided|90.0|1.01|1.47|||||Treatment ratio of adjusted geometric mean (Day 14/Day 1) for AUC(0-24) is presented||
1593296|NCT03045887|2929239|Other||Ratio|1.25|Standard Error of the Mean|0.161|||2-Sided|90.0|0.95|1.64|||||AUC(0-t).Standard error of mean was on logged scale||
1593297|NCT03045887|2929239|Other||Ratio|1.06|Standard Error of the Mean|0.255|||2-Sided|90.0|0.69|1.62|||||AUC(0-t).Standard error of mean was on logged scale||
1593298|NCT03045887|2929239|Other||Ratio|1.33|Standard Error of the Mean|0.161|||2-Sided|90.0|1.01|1.74|||||AUC(0-t).Standard error of mean was on logged scale||
1593299|NCT03045887|2929239|Other||Ratio|0.98|Standard Error of the Mean|0.243|||2-Sided|90.0|0.65|1.47|||||AUC(0-t).Standard error of mean was on logged scale||
1593300|NCT03045887|2929239|Other||Ratio|0.41|Standard Error of the Mean|0.243|||2-Sided|90.0|0.27|0.61|||||AUC(0-t). Standard error of mean was on logged scale||
1593301|NCT03045861|2929269|Other||s2e|0.2|||||2-Sided|95.0|0.094|0.305|||||||
1593302|NCT03045861|2929269|Other||ED50|32.415|||||2-Sided|95.0|4.687|60.143|||||||
1593310|NCT03045081|2929298|Other|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 < 0.05 considered statistically significant for group x time interaction|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate greater reductions in pain intensity and interference over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each time point (as treated, 'completer' analysis).|
1593311|NCT03045081|2929298|Other|Generalized estimating equations (GEE) were used to test this hypothesis.Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).|||||<|0.102||||||Wald χ2 p-values < 0.05 considered statistically significant.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate greater reductions in pain intensity and interference over time compared to the usual care group.|
1593312|NCT03045081|2929300|Other|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.001||||||Wald χ2 < 0.05 were considered statistically significant for the group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved satisfaction with pain treatment over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points (i.e., 'completer' analysis).|
1593313|NCT03045081|2929300|Other|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).|||||<|0.05||||||Wald χ2 p-values < 0.05 considered statistically significant.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved satisfaction with pain treatment over time compared to the usual care group.|
1593314|NCT03045081|2929301|Other|Generalized estimating equations were used to test this hypothesis.||||||0.143||||||Wald χ2 < 0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved confidence in patient-provider interactions over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points ('completer' analysis).|
1593315|NCT03045081|2929301|Other|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months) were evaluated (see Statistical Analysis 2).||||||0.176||||||Wald χ2 p-values < 0.05 considered statistically significant for group x time interaction|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improved confidence in patient-provider interactions over time compared to the usual care group.|
1593316|NCT03045081|2929302|Other|Generalized estimating equations were used to test this hypothesis.||||||0.167||||||Wald χ2 >0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group by time interaction such that the PTSM group would demonstrate improvement in chronic pain acceptance - Pain Willingness - over time compared to the usual care group. This analysis was restricted to those study participants who provided data at each of the study time points ('completer' analysis).|
1593317|NCT03045081|2929302|Other|Generalized estimating equations (GEE) were used to test this hypothesis.||||||0.173||||||Wald χ2 < 0.05 considered statistically significant for group x time interaction.|Wald χ2|Intent-to-treat analysis (full sample).||We hypothesized that we would observe a group by time interaction such that the PTSM group would demonstrate improvement in chronic pain acceptance - Pain Willingness - over time compared to the usual care group.|
1593318|NCT03045081|2929302|Other|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 <0.05 considered statistically significant for group x time interaction.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group by time interaction, such that the PTSM group would demonstrate improvement in chronic pain acceptance - Activity Engagement - over time compared to the usual care group.This analysis was limited to those participants who provided data at each of the study time points ('completer' analysis).|
1593319|NCT03045081|2929302|Other|Generalized estimating equations (GEE) were used to test this hypothesis. Main effects of group and time, and group × time interactions were evaluated. Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months; 'study completers') were evaluated (see Statistical Analysis 2).|||||<|0.068||||||Wald χ2 p-values < 0.05 considered statistically significant for group x time interaction|Wald χ2|Intent-to-treat analysis (full sample)||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in chronic pain acceptance - Activity Engagement - over time compared to the usual care group. Note: this questionnaire has 2 subscales, Activity Engagement and Pain Willingness. Intent-to-treat and as treated analyses were conducted for each subscale.|
1593320|NCT03045081|2929303|Other|Generalized estimating equations (GEE) were used to test this hypothesis.|||||<|0.05||||||Wald χ2 values < 0.05 considered statistically significant for group x time interactions.|Wald χ2|Study 'completers' only||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in chronic pain self-efficacy over time compared to the usual care group. This analysis was limited to those participants who provided data at each of the study time points ('completer analysis').|
1593355|NCT03042299|2929478|Equivalence|The difference in the least square (LS) means between formulations (TAK-536 pediatric formulation [granules]-TAK-536 commercial formulation [tablet]) and the two-sided 90 percent (%) confidence interval (CI) were provided using a crossover analysis of variance (ANOVA) model. The ANOVA model included log-transformed (natural log) PK parameters AUC 48 as dependent variable, and formulation, group, and period as independent variables.|Point estimate|-0.0731|||||2-Sided|90.0|-0.1088|-0.0373|||||||
1593321|NCT03045081|2929303|Other|Generalized estimating equations (GEE) were used to test this hypothesis. GEE allows for the analysis of repeated measures with unknown covariance structure and uses all available data that participants provide, even if follow-up data are missing (ie, intent-to-treat analysis). Models for the entire study sample and for only those who provided outcome data at all study time points (0, 3, 6 months; i.e., as treated 'completer' analysis) were evaluated (see Statistical Analysis 2).|||||<|0.05||||||Wald χ2 p-values < 0.05 considered statistically significant for group x time interactions.|Wald χ2|Intent-to-treat analysis (full sample)||We hypothesized that we would observe a group (usual care vs PTSM) by time (0, 3, 6 months) interaction, such that the PTSM group would demonstrate improvement in pain self efficacy over time compared to the usual care group.|
1593322|NCT03044886|2929304|Superiority|||||||0.083|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.|
1593323|NCT03044886|2929304|Superiority|||||||0.075|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.|
1593324|NCT03044886|2929305|Superiority|||||||0.685|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.|
1593325|NCT03044886|2929306|Superiority|||||||0.348|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.|
1593326|NCT03044886|2929307|Superiority|||||||0.073|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.|
1593327|NCT03044886|2929307|Superiority||||||<|0.05|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.|
1593328|NCT03044886|2929308|Superiority|||||||0.742|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.|
1593329|NCT03044886|2929309|Superiority|||||||0.521|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.|
1593330|NCT03044886|2929310|Superiority|||||||0.038|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.|
1593331|NCT03044886|2929310|Superiority|||||||0.048|||||||ANOVA||||
1593332|NCT03044886|2929311|Superiority|||||||0.34|||||||ANOVA||||
1593333|NCT03044886|2929312|Superiority|||||||0.71|||||||ANCOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.|
1593334|NCT03044886|2929313|Superiority|||||||0.041|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine changes from 3 month to 6 month of all groups.|
1593335|NCT03044886|2929313|Superiority|||||||0.042|||||||ANOVA||||
1593336|NCT03044886|2929314|Superiority|||||||0.489|||||||ANOVA||||
1593337|NCT03044886|2929315|Superiority|||||||0.576|||||||ANOVA|||One-way analysis of variance (ANOVA) and Neuman-Keuel test were carried out to determine difference between groups.|
1593338|NCT03044574|2929319|Superiority||||||<|0.001|||||||Fisher Exact||||
1593339|NCT03044574|2929321|Superiority||||||<|0.001|||||||Fisher Exact||||
1593340|NCT03044574|2929322|Superiority||||||>|0.05|||||||Fisher Exact||||
1593341|NCT03044574|2929323|Superiority||||||>|0.05|||||||Fisher Exact||||
1593342|NCT03044574|2929324|Superiority|||||||0.03|||||||Fisher Exact||||
1593343|NCT03044574|2929325|Superiority||||||<|0.001|||||||Fisher Exact||||
1593344|NCT03044574|2929326|Superiority|||||||0.03|||||||Fisher Exact||||
1593345|NCT03044574|2929327|Superiority||||||<|0.001|||||||Fisher Exact||||
1593346|NCT03044106|2929378|Superiority||Mean Difference (Final Values)|-2.024||||0.018|2-Sided|95.0|-3.4474|-0.3406|||Mixed Models Analysis|||This is the mean difference of effect between active and sham in those without a history of hamstring strain.|
1593347|NCT03044106|2929378|Superiority||Mean Difference (Final Values)|2.825||||0.09|2-Sided|95.0|-0.4543|6.0581|||Mixed Models Analysis|||This is the mean difference in effect between active and sham in those with a history of hamstring strain|
1593348|NCT03044106|2929378|Superiority||Mean Difference (Final Values)|2.688237|Standard Deviation|3.241751||0|2-Sided|95.0|1.557137|3.819337|||t-test, 2 sided|||This is the difference in pre/post KEA means in those receiving the sham treatment who have no history of hamstring strain.|
1593349|NCT03044106|2929378|Superiority||Mean Difference (Final Values)|0.6638904|Standard Deviation|3.450892||0.1281|2-Sided|95.0|-0.5037233|1.831504|||t-test, 2 sided|||This is the difference in pre/post KEA means in those receiving the active treatment with no history of hamstring strain.|
1593350|NCT03044106|2929378|Superiority||Median Difference (Final Values)|1.0|Standard Deviation|3.431784||0.2185|2-Sided|95.0|-1.869044|3.869044|||t-test, 2 sided|||This is the difference in pre /post KEA means after receiving the sham treatment in those with a history of hamstring strains.|
1593351|NCT03044106|2929378|Superiority||Mean Difference (Final Values)|3.825|Standard Deviation|3.308759||0.0068|2-Sided|95.0|1.058809|6.591192|||t-test, 2 sided|||This is the difference between pre and post KEA in those receiving the active treatment with a history of hamstring strain.|
1593352|NCT03042559|2929460|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1593353|NCT03042559|2929467|Superiority|||||||||||||||||Data analysis was performed using SPSS Statistics Software version 24.0. We compared mean age (years), Body Mass Index (kg/m2) (BMI), pain duration, and the outcome measures at baseline in both groups at baseline using independent t-test when the distribution of the variable was approximately normal and Mann-Whitney test when the distribution was not normal. The distribution of qualitative variables (gender, affected leg) by group type was examined using Chi Square test.|a priori threshold for statistical significance is <0.05.
1593354|NCT03042299|2929477|Equivalence|The difference in the LS means between formulations (TAK-536 pediatric formulation [granules]-TAK-536 commercial formulation [tablet]) and the two-sided 90% CI were provided using a crossover ANOVA model. The ANOVA model included log-transformed (natural log) PK parameters Cmax as dependent variable, and formulation, group, and period as independent variables.|Point estimate|-0.0909|||||2-Sided|90.0|-0.1573|-0.0244|||||||
1593406|NCT03039621|2929585|Other|Test for assessing the homogeneity of the odds ratio in several 2 × 2 contingency tables.||||||0.22|||||||Breslow-Day test||||
1593360|NCT03041792|2929487|Superiority||Least Square Mean Difference|-6.39|Standard Error of the Mean|2.86||0.0296|2-Sided|95.0|-12.12|-0.66|||Mixed Models Analysis|||Hunger (Visit 5)|
1593361|NCT03041792|2929487|Superiority||Least Square Mean Difference|-6.58|Standard Error of the Mean|2.44||0.0093|2-Sided|95.0|-11.48|-1.69|||Mixed Models Analysis|||Hunger (Visit 4)|
1593362|NCT03041792|2929487|Superiority||Least Square Mean Difference|-9.78|Standard Error of the Mean|3.75||0.0117|2-Sided|95.0|-17.29|-2.27|||Mixed Models Analysis|||Prospective food consumption (Visit 5)|
1593363|NCT03041792|2929487|Superiority||Least Square Mean Difference|-8.46|Standard Error of the Mean|2.91||0.0054|2-Sided|95.0|-14.3|-2.61|||Mixed Models Analysis|||Prospective food consumption (Visit 4)|
1593364|NCT03041792|2929487|Superiority||Least Square Mean Difference|1.41|Standard Error of the Mean|2.22||0.5288|2-Sided|95.0|-3.05|5.86|||Mixed Models Analysis|||Fullness (Visit 5)|
1593365|NCT03041792|2929487|Superiority||Least Square Mean Difference|2.85|Standard Error of the Mean|2.12||0.1858|2-Sided|95.0|-1.41|7.11|||Mixed Models Analysis|||Fullness (Visit 4)|
1593366|NCT03041792|2929487|Superiority||Least Square Mean Difference|3.43|Standard Error of the Mean|2.13||0.1137|2-Sided|95.0|-0.85|7.7|||Mixed Models Analysis|||Satiety (Visit 5)|
1593367|NCT03041792|2929487|Superiority||Least Square Mean Difference|3.98|Standard Error of the Mean|2.91||0.1768|2-Sided|95.0|-1.85|9.82|||Mixed Models Analysis|||Satiety (Visit 4)|
1593368|NCT03041792|2929488|Superiority||Least Square Mean Difference|5.35|Standard Error of the Mean|2.06||0.0121|2-Sided|95.0|1.22|9.48|||Mixed Models Analysis|||Visit 5|
1593369|NCT03041792|2929488|Superiority||Least Square Mean Difference|4.95|Standard Error of the Mean|2.16||0.0263|2-Sided|95.0|0.61|9.29|||Mixed Models Analysis|||Visit 4|
1593370|NCT03041792|2929489|Superiority||Least Square Mean Difference|-928.56|Standard Error of the Mean|193.8||0|2-Sided|95.0|-1317.3|-539.86||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of <0.05.|Mixed Models Analysis|||Visit 5|
1593371|NCT03041792|2929489|Superiority||Least Square Mean Difference|-859.58|Standard Error of the Mean|167.76||0|2-Sided|95.0|-1196.1|-523.1||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of <0.05.|Mixed Models Analysis|||Visit 4|
1593372|NCT03041792|2929494|Superiority||Least Square Mean Difference|-243.63|Standard Error of the Mean|47.6||0|2-Sided|95.0|-339.1|-148.15||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of <0.05.|Mixed Models Analysis|||Visit 5|
1593373|NCT03041792|2929494|Superiority||Least Square Mean Difference|-235.75|Standard Error of the Mean|43.13||0|2-Sided|95.0|-322.25|-149.25||The p-value was calculated and was rounded to 4th decimal presenting as 0.0000, which was smaller than the required threshold of <0.05.|Mixed Models Analysis|||Visit 4|
1593374|NCT03041467|2929495|Superiority|||||||1||||||P-value is at 6 Months.|Fisher Exact||||
1593375|NCT03041467|2929496|Superiority|||||||0.623||||||This is the p-value at 6 Months.|Fisher Exact||||
1593376|NCT03041467|2929497|Superiority||||||>|0.999|||||||Chi-squared||||
1593377|NCT03041467|2929498|Superiority|||||||0.482|||||||Chi-squared||||
1593378|NCT03041467|2929499|Superiority||||||>|0.999|||||||Chi-squared||||
1593379|NCT03041467|2929500|Superiority|||||||0.222||||||There is no planned test for 3 Month endpoint, therefore no p-value at 3 Months. P-value listed is at 6 Months.|Chi-squared||||
1593380|NCT03041467|2929503|Superiority||||||<|0.001||||||There is no planned test for 3 Month endpoint, therefore no p value at 3 Months. P value is at 6 Months.|Chi-squared||||
1593381|NCT03041467|2929504|Other|There is no planned test for 3 Month endpoint, therefore no p-value at 3 Months.||||||||||||||||Kaplan-Meier survival curve was used to estimate target lesion primary patency.|Survival analysis will be performed using Kaplan-Meier method.
1593382|NCT03041467|2929505|Superiority||||||<|0.001||||||There is no planned test for 3 Month endpoint, therefore no p-value at 3 Months. P-value listed is at 6 Months.|Log Rank|||Kaplan-Meier method was used to estimate access circuit primary patency.|
1593383|NCT03041467|2929506|Non-Inferiority|Non-inferiority p-values for the primary safety endpoint was based on the Farrington-Manning non-inferiority test with a margin of 7.5%.||||||0.002|||||||Farrington-Manning Method||||
1593384|NCT03041467|2929507|Superiority||||||<|0.001|||||||One-sided Z-test||||
1593385|NCT03040011|2929555|Superiority|||||||0.44|||||||Kruskal-Wallis||||
1593386|NCT03040011|2929556|Superiority|||||||0.4|||||||Kruskal-Wallis||||
1593387|NCT03040011|2929557|Superiority|||||||0.68|||||||Kruskal-Wallis||||
1593388|NCT03040011|2929558|Superiority|||||||0.18|||||||Kruskal-Wallis||||
1593389|NCT03040011|2929559|Superiority|||||||0.32|||||||Kruskal-Wallis||||
1593390|NCT03040011|2929560|Superiority|||||||0.35|||||||Kruskal-Wallis||||
1593391|NCT03040011|2929561|Superiority|||||||0.19|||||||Chi-squared||||
1593392|NCT03040011|2929562|Superiority|||||||0.49|||||||Chi-squared||||
1593393|NCT03040011|2929563|Superiority|||||||0.9|||||||Chi-squared||||
1593394|NCT03040011|2929564|Superiority|||||||0.96|||||||Chi-squared||||
1593395|NCT03040011|2929566|Superiority|||||||0.41|||||||Kruskal-Wallis||||
1593396|NCT03040011|2929567|Superiority|||||||0.64|||||||Chi-squared||||
1593397|NCT03040011|2929568|Superiority|||||||0.72|||||||Chi-squared||||
1593398|NCT03040011|2929569|Superiority|||||||0.8|||||||Chi-squared||||
1593399|NCT03040011|2929570|Superiority|||||||0.54|||||||Kruskal-Wallis||||
1593400|NCT03040011|2929571|Superiority|||||||0.45|||||||Kruskal-Wallis||||
1593401|NCT03040011|2929572|Superiority|||||||0.17|||||||Kruskal-Wallis||||
1593402|NCT03040011|2929573|Superiority|||||||0.25|||||||Kruskal-Wallis||||
1593403|NCT03040011|2929574|Superiority|||||||0.39|||||||Kruskal-Wallis||||
1593404|NCT03039621|2929583|Superiority|||||||0.0001|||||||Fisher Exact||||
1593405|NCT03039621|2929584|Superiority|||||||0.0037||||||"The p-value associated with treatment factor of total severity index of the disease from Day 1 to Day 2, 3 and 4 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis||||
1593409|NCT03039621|2929587|Superiority|||||||0.0201||||||"The p-value associated with treatment factor of total severity index of the disease from Day 2 to Day 3, 4, 5 and 6 endpoint between Ergoferon and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis||||
1593410|NCT03039621|2929588|Superiority|||||||0.024|||||||Wilcoxon (Mann-Whitney)||||
1593411|NCT03039621|2929589|Superiority|||||||0.022|||||||Wilcoxon (Mann-Whitney)||||
1593412|NCT03039621|2929590|Superiority|||||||0.031|||||||Wilcoxon (Mann-Whitney)||||
1593413|NCT03039621|2929591|Superiority|||||||0.026||||||a priori threshold for statistical significance equals 0.05|Wilcoxon (Mann-Whitney)||||
1593414|NCT03037905|2929681|Superiority|||||||0.83|||||||Wilcoxon (Mann-Whitney)||||
1593415|NCT03037905|2929682|Superiority||Mean Difference (Final Values)|-1.0||||0.76|2-Sided|95.0|-7.0|5.1|||Mixed Models Analysis||||
1593416|NCT03037905|2929683|Superiority||Mean Difference (Final Values)|2.2||||0.6|2-Sided|95.0|-5.9|10.3|||Mixed Models Analysis||||
1593417|NCT03037905|2929684|Superiority||Mean Difference (Final Values)|-6.7||||0.2|2-Sided|95.0|-17.1|3.7|||Mixed Models Analysis||||
1593418|NCT03037307|2929692|Other||Least Square (LS) mean difference|2.12|||<|0.0001|2-Sided|95.0|1.25|3.0|||ANCOVA|ANCOVA: factors for participant (random effect); period & treatment, participant-level & period-level pre-treatment baseline bite force as covariates|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.||
1593419|NCT03037307|2929693|Other||Least square (LS) mean difference|2.76|||<|0.0001|2-Sided|95.0|1.89|3.63||Treatment Comparison for study validity.|ANCOVA|ANCOVA: factors for participant (random effect); period & treatment, participant-level & period-level pre-treatment baseline bite force as covariates.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.||
1593420|NCT03036215|2929742|Other||Mean Difference (Net)|-5.2|||||2-Sided|||||||||Pilot study; no statistical test for significance run|
1593421|NCT03036215|2929743|Other|pilot study; no statistical test performed|Mean Difference (Net)|1.0|||||2-Sided|||||||||Pilot study; no statistical test run|
1593422|NCT03036215|2929744|Other||Mean Difference (Net)|-7.0|||||2-Sided|||||||||Pilot study, no power analysis applicable; no statistical test|
1593423|NCT03035916|2929774|Other|||||||0.518|||||||t-test, 2 sided||||
1593424|NCT03035916|2929774|Other|||||||0.987|||||||t-test, 2 sided||||
1593425|NCT03035916|2929774|Other|||||||0.972|||||||t-test, 2 sided||||
1593426|NCT03035916|2929775|Other|||||||0.785|||||||t-test, 2 sided||||
1593427|NCT03035916|2929775|Other|||||||0.864|||||||t-test, 2 sided||||
1593428|NCT03035916|2929775|Other|||||||0.91|||||||t-test, 2 sided||||
1593429|NCT03035916|2929776|Other|||||||0.007|||||||t-test, 2 sided||||
1593430|NCT03035916|2929776|Other|||||||0.046|||||||t-test, 2 sided||||
1593431|NCT03035916|2929776|Other|||||||0.421|||||||t-test, 2 sided||||
1593432|NCT03035916|2929777|Other|||||||0.031|||||||t-test, 2 sided||||
1593433|NCT03035916|2929777|Other|||||||0.045|||||||t-test, 2 sided||||
1593434|NCT03035916|2929777|Other|||||||0.644|||||||t-test, 2 sided||||
1593435|NCT03035916|2929778|Other|||||||0.13|||||||t-test, 2 sided||||
1593436|NCT03035916|2929778|Other|||||||0.071|||||||t-test, 2 sided||||
1593437|NCT03035916|2929778|Other|||||||0.585|||||||t-test, 2 sided||||
1593438|NCT03035916|2929779|Other|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."|
1593439|NCT03035916|2929779|Other|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."|
1593440|NCT03035916|2929779|Other|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."|
1593441|NCT03035916|2929779|Other|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."|
1593442|NCT03035916|2929779|Other|||||||0.005|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."|
1593443|NCT03035916|2929779|Other|||||||0.004|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."|
1593444|NCT03035916|2929779|Other|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."|
1593445|NCT03035916|2929779|Other|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."|
1593446|NCT03035916|2929779|Other|||||||0.057|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."|
1593447|NCT03035916|2929779|Other|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."|
1593448|NCT03035916|2929779|Other|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."|
1593449|NCT03035916|2929779|Other|||||||0.228|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."|
1593450|NCT03035916|2929779|Other|||||||0.001||||||p<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."|
1593451|NCT03035916|2929779|Other|||||||0.176||||||p<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."|
1597176|NCT02915835|2935796|Superiority|||||||1|||||||Fisher Exact||||
1593452|NCT03035916|2929780|Other|||||||0.052|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."|
1593453|NCT03035916|2929780|Other|||||||0.124|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."|
1593454|NCT03035916|2929780|Other|||||||0.425|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 48 hours after surgery row."|
1593455|NCT03035916|2929780|Other|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."|
1593456|NCT03035916|2929780|Other|||||||0.023|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."|
1593457|NCT03035916|2929780|Other|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 24 hours after surgery row."|
1593458|NCT03035916|2929780|Other|||||||0.001|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."|
1593459|NCT03035916|2929780|Other|||||||0.005|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."|
1593460|NCT03035916|2929780|Other|||||||0.102|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 12 hours after surgery row."|
1593461|NCT03035916|2929780|Other|||||||0.002|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."|
1593462|NCT03035916|2929780|Other|||||||0.047|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."|
1593463|NCT03035916|2929780|Other|||||||0.198|||||||t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 6 hours after surgery row."|
1593464|NCT03035916|2929780|Other|||||||0.001||||||p<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."|
1593465|NCT03035916|2929780|Other|||||||0.009||||||p<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."|
1593466|NCT03035916|2929780|Other|||||||0.056||||||p<0.05 indicates that the data difference is statistically significant.|t-test, 2 sided|||"The pain score were measured from 1 hour to 48hours after surgery. This Statistical Analysis applied to 1 hour after surgery row."|
1593467|NCT03035916|2929781|Other|||||||0.001|||||||t-test, 2 sided||||
1593468|NCT03035916|2929781|Other|||||||0.001|||||||t-test, 2 sided||||
1593469|NCT03035916|2929781|Other|||||||0.056|||||||t-test, 2 sided||||
1593470|NCT03035916|2929782|Other|||||||0.079|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."|
1593471|NCT03035916|2929782|Other|||||||0.739|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."|
1593472|NCT03035916|2929782|Other|||||||0.168|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."|
1593473|NCT03035916|2929782|Other|||||||0.065|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|
1593474|NCT03035916|2929782|Other|||||||0.555|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|
1593475|NCT03035916|2929782|Other|||||||0.186|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|
1593476|NCT03035916|2929782|Other|||||||0.051|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."|
1593477|NCT03035916|2929782|Other|||||||0.299|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."|
1593478|NCT03035916|2929782|Other|||||||0.288|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."|
1593479|NCT03035916|2929782|Other|||||||0.166|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."|
1593480|NCT03035916|2929782|Other|||||||0.058|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."|
1593481|NCT03035916|2929782|Other|||||||0.555|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."|
1597177|NCT02915835|2935797|Superiority|||||||1|||||||Fisher Exact||||
1593482|NCT03035916|2929782|Other|||||||0.001|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."|
1593483|NCT03035916|2929782|Other|||||||0.001|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."|
1593484|NCT03035916|2929782|Other|||||||0.921|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."|
1593485|NCT03035916|2929782|Other|||||||0.306|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."|
1593486|NCT03035916|2929782|Other|||||||0.787|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."|
1593487|NCT03035916|2929782|Other|||||||0.411|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."|
1593488|NCT03035916|2929782|Other|||||||0.026|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."|
1593489|NCT03035916|2929782|Other|||||||0.873|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."|
1593490|NCT03035916|2929782|Other|||||||0.009|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."|
1593491|NCT03035916|2929782|Other|||||||0.031|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."|
1593492|NCT03035916|2929782|Other|||||||0.367|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."|
1593493|NCT03035916|2929782|Other|||||||0.003|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."|
1593494|NCT03035916|2929782|Other|||||||0.314|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."|
1593495|NCT03035916|2929782|Other|||||||0.645|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."|
1593496|NCT03035916|2929782|Other|||||||0.645|||||||t-test, 2 sided|||"The mean arterial pressure(MAP) was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."|
1593497|NCT03035916|2929783|Other|||||||0.112|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."|
1593498|NCT03035916|2929783|Other|||||||0.187|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."|
1593499|NCT03035916|2929783|Other|||||||0.763|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."|
1593500|NCT03035916|2929783|Other|||||||0.011|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|
1593501|NCT03035916|2929783|Other|||||||0.026|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|
1593502|NCT03035916|2929783|Other|||||||0.72|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|
1593503|NCT03035916|2929783|Other|||||||0.159|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."|
1593504|NCT03035916|2929783|Other|||||||0.489|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."|
1593505|NCT03035916|2929783|Other|||||||0.445|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."|
1593506|NCT03035916|2929783|Other|||||||0.167|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."|
1593507|NCT03035916|2929783|Other|||||||0.411|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."|
1608202|NCT02610868|2953672|Superiority||||||<|0.0006|||||||ANCOVA||||
1593508|NCT03035916|2929783|Other|||||||0.555|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Extubation row."|
1593509|NCT03035916|2929783|Other|||||||0.001|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."|
1593510|NCT03035916|2929783|Other|||||||0.001|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."|
1593511|NCT03035916|2929783|Other|||||||0.494|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Incision row."|
1593512|NCT03035916|2929783|Other|||||||0.143|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."|
1593513|NCT03035916|2929783|Other|||||||0.262|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."|
1593514|NCT03035916|2929783|Other|||||||0.655|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Intubation row."|
1593515|NCT03035916|2929783|Other|||||||0.042|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."|
1593516|NCT03035916|2929783|Other|||||||0.406|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."|
1593517|NCT03035916|2929783|Other|||||||0.006|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Induction row."|
1593518|NCT03035916|2929783|Other|||||||0.046|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."|
1593519|NCT03035916|2929783|Other|||||||0.667|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."|
1593520|NCT03035916|2929783|Other|||||||0.108|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Before induction row."|
1593521|NCT03035916|2929783|Other|||||||0.819|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."|
1593522|NCT03035916|2929783|Other|||||||0.53|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."|
1593523|NCT03035916|2929783|Other|||||||0.384|||||||t-test, 2 sided|||"The Heart rate was measured from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."|
1593524|NCT03035916|2929784|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."|
1593525|NCT03035916|2929784|Other|||||||0.023|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."|
1593526|NCT03035916|2929784|Other|||||||0.087|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."|
1593527|NCT03035916|2929784|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|
1593528|NCT03035916|2929784|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|
1593529|NCT03035916|2929784|Other|||||||0.314||||||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|
1593530|NCT03035916|2929784|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."|
1593531|NCT03035916|2929784|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."|
1593532|NCT03035916|2929784|Other|||||||0.079|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."|
1593749|NCT03028142|2930110|Other||LS Means ratio|1.09|||<|0.0001|2-Sided|95.0|1.05|1.12|||ANCOVA||||
1608203|NCT02610868|2953672|Superiority||||||<|0.0001|||||||ANCOVA||||
1593533|NCT03035916|2929784|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."|
1593534|NCT03035916|2929784|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."|
1593535|NCT03035916|2929784|Other|||||||0.067|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."|
1593536|NCT03035916|2929784|Other|||||||0.493|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."|
1593537|NCT03035916|2929784|Other|||||||0.091|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."|
1593538|NCT03035916|2929784|Other|||||||0.249|||||||t-test, 2 sided|||"The plasma level of glucose (Glu) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."|
1593539|NCT03035916|2929785|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."|
1593540|NCT03035916|2929785|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."|
1593541|NCT03035916|2929785|Other|||||||0.561|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 48 hours after surgery row."|
1593542|NCT03035916|2929785|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|
1593543|NCT03035916|2929785|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|
1593544|NCT03035916|2929785|Other|||||||0.069|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 24 hours after surgery row."|
1593545|NCT03035916|2929785|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."|
1593546|NCT03035916|2929785|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."|
1593547|NCT03035916|2929785|Other|||||||0.057|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 6 hours after surgery row."|
1593548|NCT03035916|2929785|Other|||||||0.002|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."|
1593549|NCT03035916|2929785|Other|||||||0.026|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."|
1593550|NCT03035916|2929785|Other|||||||0.303|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to 0 hour after surgery row."|
1593551|NCT03035916|2929785|Other|||||||0.547|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."|
1593552|NCT03035916|2929785|Other|||||||0.824|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."|
1593553|NCT03035916|2929785|Other|||||||0.673|||||||t-test, 2 sided|||"The plasma level of cortisol (Cor) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control.This Statistical Analysis applied to Baseline row."|
1593554|NCT03035916|2929786|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."|
1593555|NCT03035916|2929786|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."|
1593556|NCT03035916|2929786|Other|||||||0.305|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."|
1593557|NCT03035916|2929786|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."|
1593558|NCT03035916|2929786|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."|
1593559|NCT03035916|2929786|Other|||||||0.165|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."|
1593560|NCT03035916|2929786|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."|
1593561|NCT03035916|2929786|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."|
1593562|NCT03035916|2929786|Other|||||||0.872|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."|
1593563|NCT03035916|2929786|Other|||||||0.201|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."|
1593564|NCT03035916|2929786|Other|||||||0.427|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."|
1593565|NCT03035916|2929786|Other|||||||0.576|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."|
1593566|NCT03035916|2929786|Other|||||||0.796|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."|
1593567|NCT03035916|2929786|Other|||||||0.592|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."|
1593568|NCT03035916|2929786|Other|||||||0.412|||||||t-test, 2 sided|||"The plasma level of epinephrine (E) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."|
1593569|NCT03035916|2929787|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."|
1593570|NCT03035916|2929787|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."|
1593571|NCT03035916|2929787|Other|||||||0.411|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 48 hours after surgery row."|
1593572|NCT03035916|2929787|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."|
1593573|NCT03035916|2929787|Other|||||||0.007|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."|
1593574|NCT03035916|2929787|Other|||||||0.464|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 24 hours after surgery row."|
1593575|NCT03035916|2929787|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."|
1593576|NCT03035916|2929787|Other|||||||0.001|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."|
1593577|NCT03035916|2929787|Other|||||||0.139|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 6 hours after surgery row."|
1593578|NCT03035916|2929787|Other|||||||0.26|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."|
1593579|NCT03035916|2929787|Other|||||||0.523|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."|
1593580|NCT03035916|2929787|Other|||||||0.54|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to 0 hour after surgery row."|
1593581|NCT03035916|2929787|Other|||||||0.901|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."|
1593750|NCT03028142|2930110|Other||LS Means ratio|1.05|||<|0.0022|2-Sided|95.0|1.02|1.09|||ANCOVA||||
1608204|NCT02610868|2953672|Superiority||||||<|0.0001|||||||ANCOVA||||
1593582|NCT03035916|2929787|Other|||||||0.402|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."|
1593583|NCT03035916|2929787|Other|||||||0.454|||||||t-test, 2 sided|||"The plasma level of norepinephrine(NE) were detected from baseline to 48hours after surgery. The row Baseline is the preoperative level as the blank control. This Statistical Analysis applied to Baseline row."|
1593584|NCT03035864|2929788|Superiority||difference in least square means|-1.49|||=|0|2-Sided|95.0|-6.41|3.44|||ANCOVA|||Severeity - Week 12|
1593585|NCT03035864|2929788|Superiority||difference in least square means|2.86|||=|0|2-Sided|95.0|-3.75|9.47|||ANCOVA|||Severity - Week 8|
1593586|NCT03035864|2929788|Superiority||Difference in least square means|0.62|||=|0|2-Sided|95.0|-5.04|6.29|||ANCOVA|||Severity - Week 4|
1593587|NCT03035864|2929788|Superiority||difference in least square means|-2.29|||=|0|2-Sided|95.0|-7.97|3.38|||ANCOVA|||Frequency - Week 12|
1593588|NCT03035864|2929788|Superiority||difference in least square means|-0.31|||=|0|2-Sided|95.0|-6.96|6.33|||ANCOVA|||Frequency - week 8|
1593589|NCT03035864|2929788|Superiority||difference in least square means|-0.43|||=|0|2-Sided|95.0|-6.13|5.27|||ANCOVA|||Frequency - week 4|
1593590|NCT03035864|2929792|Superiority||difference in least square means|0.04|||=|0|2-Sided|95.0|-0.02|0.1|||ANCOVA||||
1593591|NCT03035864|2929793|Superiority||Difference in least square means|2.88|||=|0|2-Sided|95.0|-3.85|9.61|||ANCOVA|||Statistical analysis related to severity|
1593592|NCT03035864|2929793|Superiority||difference in LS means|-0.11|||=|0|2-Sided|95.0|-6.85|6.63|||ANCOVA|||Frequency statistical analysis|
1593593|NCT03034967|2929820|Other||Odds Ratio (OR)|1.26||||0.501|2-Sided|90.0|0.72|2.2||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||
1593594|NCT03034967|2929820|Other||Odds Ratio (OR)|1.21||||0.567|2-Sided|90.0|0.69|2.13||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||
1593595|NCT03034967|2929820|Other||Odds Ratio (OR)|0.95||||0.887|2-Sided|90.0|0.55|1.66||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||
1593596|NCT03034967|2929820|Other||Odds Ratio (OR)|0.93||||0.825|2-Sided|90.0|0.53|1.63||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||
1593597|NCT03034967|2929820|Other||Odds Ratio (OR)|1.01||||0.973|2-Sided|90.0|0.58|1.76||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||
1593598|NCT03034967|2929822|Other||Odds Ratio (OR)|0.9||||0.763|2-Sided|90.0|0.52|1.58||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||
1593599|NCT03034967|2929822|Other||Odds Ratio (OR)|1.31||||0.426|2-Sided|90.0|0.75|2.26||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||
1593600|NCT03034967|2929822|Other||Odds Ratio (OR)|1.47||||0.239|2-Sided|90.0|0.86|2.53||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||
1593601|NCT03034967|2929822|Other||Odds Ratio (OR)|1.27||||0.482|2-Sided|90.0|0.73|2.2||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||
1593602|NCT03034967|2929822|Other||Odds Ratio (OR)|1.51||||0.208|2-Sided|90.0|0.88|2.59||Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.|Linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||
1593603|NCT03034967|2929825|Other|Bayesian proportional hazards model|Hazard Ratio (HR)|0.8|||||2-Sided|90.0|0.2|2.7|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
1593604|NCT03034967|2929825|Other|Bayesian proportional hazards model|Hazard Ratio (HR)|2.3|||||2-Sided|90.0|0.9|6.9|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
1608205|NCT02610868|2953672|Superiority||||||<|0.0001|||||||ANCOVA||||
1593605|NCT03034967|2929825|Other|Bayesian proportional hazards model|Hazard Ratio (HR)|1.8|||||2-Sided|90.0|0.7|5.6|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
1593606|NCT03034967|2929825|Other|Bayesian proportional hazards model|Hazard Ratio (HR)|1.9|||||2-Sided|90.0|0.7|5.8|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
1593607|NCT03034967|2929825|Other|Bayesian proportional hazards model|Hazard Ratio (HR)|1.8|||||2-Sided|90.0|0.7|5.5|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
1593608|NCT03034967|2929826|Other|Bayesian proportional hazards model|Hazard Ratio (HR)|1.6|||||2-Sided|90.0|1.1|2.3|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
1593609|NCT03034967|2929826|Other|Bayesian proportional hazards model|Hazard Ratio (HR)|1.4|||||2-Sided|90.0|1.0|2.1|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
1593610|NCT03034967|2929826|Other|Bayesian proportional hazards model|Hazard Ratio (HR)|1.1|||||2-Sided|90.0|0.7|1.6|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
1593611|NCT03034967|2929826|Other|Bayesian proportional hazards model|Hazard Ratio (HR)|1.1|||||2-Sided|90.0|0.8|1.7|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
1593612|NCT03034967|2929826|Other|Bayesian proportional hazards model|Hazard Ratio (HR)|1.5|||||2-Sided|90.0|1.0|2.2|||||Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator %predicted FEV1 at Screening.
1593613|NCT03034967|2929829|Other||Median Posterior Hazard Ratio|2.0|||||2-Sided|90.0|0.9|4.5|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
1593614|NCT03034967|2929829|Other||Median Posterior Hazard Ratio|2.0|||||2-Sided|90.0|1.0|4.3|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
1593615|NCT03034967|2929829|Other||Median Posterior Hazard Ratio|1.4|||||2-Sided|90.0|0.6|3.2|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
1593616|NCT03034967|2929829|Other||Median Posterior Hazard Ratio|1.0|||||2-Sided|90.0|0.4|2.4|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.
1593617|NCT03034967|2929829|Other||Median Posterior Hazard Ratio|1.2|||||2-Sided|90.0|0.5|2.6|||||Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||DNX versus (vs.) Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (<=1/>=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted Forced Expiratory Volume in one second (FEV1)at Screening.
1593618|NCT03034967|2929831|Other||Odds Ratio (OR)|1.01||||0.987|2-Sided|90.0|0.59|1.71||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.||
1593619|NCT03034967|2929831|Other||Odds Ratio (OR)|0.92||||0.804|2-Sided|90.0|0.54|1.58||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.||
1593620|NCT03034967|2929831|Other||Odds Ratio (OR)|0.87||||0.674|2-Sided|90.0|0.51|1.48||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.||
1593828|NCT03019627|2930487|Superiority||Difference in least square means|-0.3|||=|0|2-Sided|95.0|-1.05|0.44|||ANCOVA|||week 8|
1593621|NCT03034967|2929831|Other||Odds Ratio (OR)|1.05||||0.881|2-Sided|90.0|0.62|1.79||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.||
1593622|NCT03034967|2929831|Other||Odds Ratio (OR)|1.71||||0.089|2-Sided|90.0|1.02|2.86||Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.|linear mixed model||Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.||
1593623|NCT03034967|2929838|Other|Log-linear|Median Posterior Difference|0.01|||||2-Sided|90.0|-0.29|0.31|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|Log-linear model|
1593624|NCT03034967|2929838|Other|Log-linear|Median Posterior Difference|0.01|||||2-Sided|90.0|-0.28|0.3|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|Log-linear model|
1593625|NCT03034967|2929838|Other|Log-linear|Median Posterior Difference|0.01|||||2-Sided|90.0|-0.27|0.29|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|Log-linear model|
1593626|NCT03034967|2929838|Other|Log-linear|Median Posterior Difference|0.01|||||2-Sided|90.0|-0.23|0.25|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|Log-linear model|
1593627|NCT03034967|2929838|Other|Log-linear|Median Posterior Difference|0.01|||||2-Sided|90.0|-0.21|0.23|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|Log-linear model.|
1593628|NCT03034967|2929839|Other|Emax|Median Posterior Difference|0.45|||||2-Sided|90.0|0.26|0.66|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.|
1593629|NCT03034967|2929839|Other|Emax|Median Posterior Difference|0.42|||||2-Sided|90.0|0.21|0.64|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.|
1593630|NCT03034967|2929839|Other|Emax|Median Posterior Difference|0.38|||||2-Sided|90.0|0.04|0.61|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.|
1593631|NCT03034967|2929839|Other|Emax|Median Posterior Difference|0.12|||||2-Sided|90.0|0.0|0.43|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model|
1593632|NCT03034967|2929839|Other|Emax|Median Posterior Difference|0.01|||||2-Sided|90.0|0.0|0.16|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.|
1593633|NCT03034967|2929840|Other|Emax|Median Posterior Difference|0.73|||||2-Sided|90.0|0.4|1.12|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.|
1593634|NCT03034967|2929840|Other|Emax|Median Posterior Difference|0.72|||||2-Sided|90.0|0.37|1.1|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.|
1593635|NCT03034967|2929840|Other|Emax|Median Posterior Difference|0.68|||||2-Sided|90.0|0.23|1.08|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.|
1593636|NCT03034967|2929840|Other|Emax|Median Posterior Difference|0.43|||||2-Sided|90.0|0.0|0.87|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model|
1593637|NCT03034967|2929840|Other|Emax|Median Posterior Difference|0.09|||||2-Sided|90.0|0.0|0.42|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.|
1593638|NCT03034967|2929841|Other|Emax|Median Posterior Difference|1.38|||||2-Sided|90.0|0.79|2.07|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.|4-parameter Emax model selected.|
1593639|NCT03034967|2929841|Other|Emax|Median Posterior Difference|1.34|||||2-Sided|90.0|0.72|2.03|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.|4-parameter Emax model selected.|
1593640|NCT03034967|2929841|Other|Emax|Median Posterior Difference|1.25|||||2-Sided|90.0|0.43|1.97|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.|4-parameter Emax model selected.|
1593641|NCT03034967|2929841|Other|Emax|Median Posterior Difference|0.61|||||2-Sided|90.0|0.0|1.52|||||Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.|4-parameter Emax model|
1593642|NCT03034967|2929841|Other|Emax|Median Posterior Difference|0.08|||||2-Sided|90.0|0.0|0.66|||||Median posterior difference, 90 percent (%) credible interval for Placebo and Danirixin 5 mg has been presented.|4-parameter Emax model selected.|
1593643|NCT03034954|2929843|Other|||||||0.219|||||||Fisher Exact||||
1593644|NCT03034954|2929844|Other|||||||0.488|||||||Fisher Exact||||
1593645|NCT03034954|2929845|Other|||||||0.49|||||||Fisher Exact||||
1593646|NCT03034954|2929846|Other|||||||0.082|||||||Fisher Exact||||
1593647|NCT03034954|2929847|Other|||||||0.281|||||||Fisher Exact||||
1593648|NCT03034954|2929848|Other|||||||0.999|||||||Fisher Exact||||
1593649|NCT03034954|2929849|Other|||||||0.6|||||||Fisher Exact||||
1593650|NCT03034954|2929851|Other|||||||0.233|||||||Fisher Exact||||
1593651|NCT03034954|2929852|Other|||||||0.078|||||||Chi-squared|||Chi-squared tests were conducted to determine group differences in actual condition assignment vs. estimated/perceived condition|
1593652|NCT03034954|2929853|Other|||||||0.45|||||||MANOVA|||A Multivariate ANOVA was used to compare Active vs. Sham groups on discriminability measures (i.e. 0-back d', 2-back d', semantic 2-back d') and calculated working memory measures (i.e., 2-back d' minus 0-back d', semantic 2-back d' minus 0-back d').|
1593653|NCT03034954|2929858|Other|||||||0.3|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Recognition Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).|
1597178|NCT02915835|2935798|Superiority|||||||1|||||||Fisher Exact||||
1593654|NCT03034954|2929860|Other|||||||0.15|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Cued Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).|
1593655|NCT03034954|2929863|Other|||||||0.006|||||||Repeated Measures ANOVA|||Univariate analysis of the OLTT Free Recall Average Time to Respond following significant multivariate repeated measures ANOVA comparing baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham).|
1593656|NCT03034954|2929863|Other|||||||0.044||||||Statistic represents the interaction between Time (baseline to post-tDCS) by Condition (Active vs. Sham).|Repeated Measures ANOVA|||A Repeated Measures ANOVA was used to compare baseline OLTT (Version B) to post-tDCS OLTT (Version C) across the treatment groups (Active vs. Sham). The multivariate analyses included OLTT Response Times (i.e., Free Recall Average Response Time, Cued Recall Average Response Time, Recognition Average Response Time)|
1593657|NCT03034954|2929865|Other|||||||0.3||||||Reported p-value represents Time (baseline to post-tDCS) x Condition (Active or Sham) interaction for all OLTT Accuracy Measures. If the multivariate statistic is not significant no univariate statistical analyses are completed.|Repeated Measures ANOVA|repeated measures (OLTT baseline and post-tDCS); between-subjects (active vs. sham)||We used a multivariate statistic to compare OLTT means (Free Recall Total Error, Free Recall Average Error, Cued Recall Total Error, Cued Recall Average Error, Recognition Total Correct) at baseline (Version B) to post HD-tDCS OLTT means (Version C), by groups (active vs. sham). The overall statistic represents the simultaneous comparison of baseline OLTT measures to post HD-tDCS OLTT measures.|
1593658|NCT03034915|2929868|Other||Odds Ratio (OR)|0.91||||0.363|2-Sided|95.0|0.75|1.11|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.||
1593659|NCT03034915|2929868|Other||Odds Ratio (OR)|1.23||||0.037|2-Sided|95.0|1.01|1.5|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24.||
1593660|NCT03034915|2929868|Other||Odds Ratio (OR)|1.35||||0.003|2-Sided|95.0|1.11|1.65|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus UMEC at Week 24.||
1593661|NCT03034915|2929869|Other||Odds Ratio (OR)|-0.5|Standard Error of the Mean|0.31||0.107|2-Sided|95.0|-1.1|0.1|||mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24.||
1593662|NCT03034915|2929869|Other||Mean Difference (Net)|-0.5|Standard Error of the Mean|0.3||0.074|2-Sided|95.0|-1.1|0.1|||mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.||
1593663|NCT03034915|2929869|Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.3||0.891|2-Sided|95.0|-0.6|0.6|||mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.||
1593664|NCT03034915|2929870|Other||Odds Ratio (OR)|1.23||||0.045|2-Sided|95.0|1.0|1.51|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.||
1593665|NCT03034915|2929870|Other||Odds Ratio (OR)|1.49|||<|0.001|2-Sided|95.0|1.22|1.83|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24.||
1593666|NCT03034915|2929870|Other||Odds Ratio (OR)|1.21|||<|0.063|2-Sided|95.0|0.99|1.48|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus UMEC at Week 24.||
1593667|NCT03034915|2929871|Other||Mean Difference (Net)|-1.94|Standard Error of the Mean|0.678||0.004|2-Sided|95.0|-3.27|-0.61|||mixed model repeated measure||LS Mean difference comparing UMEC versus salmeterol at Week 24.||
1593668|NCT03034915|2929871|Other||Mean Difference (Net)|-1.69|Standard Error of the Mean|0.665||0.011|2-Sided|95.0|-2.99|-0.39|||mixed model repeated measure||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.||
1593669|NCT03034915|2929871|Other||Mean Difference (Net)|0.25|Standard Error of the Mean|0.672||0.709|2-Sided|95.0|-1.07|1.57|||mixed model repeated measure||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.||
1593670|NCT03034915|2929872|Other||Odds Ratio (OR)|1.0||||0.969|2-Sided|95.0|0.8|1.26|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 21 to Week 24.||
1593671|NCT03034915|2929872|Other||Odds Ratio (OR)|1.53|||<|0.001|2-Sided|95.0|1.23|1.9|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 21 to Week 24.||
1593672|NCT03034915|2929872|Other||Odds Ratio (OR)|1.52|||<|0.001|2-Sided|95.0|1.22|1.89|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI vs UMEC at Week 21 to Week 24||
1593673|NCT03034915|2929873|Other||Mean Difference (Net)|-0.07|Standard Error of the Mean|0.07||0.34|2-Sided|95.0|-0.2|0.07||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.||
1593674|NCT03034915|2929873|Other||Mean Difference (Net)|-0.24|Standard Error of the Mean|0.069|<|0.001|2-Sided|95.0|-0.37|-0.1||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comapring UMEC/VI versus salmeterol at Week 21 to Week 24.||
1593675|NCT03034915|2929873|Other||Mean Difference (Net)|-0.17|Standard Error of the Mean|0.07|<|0.014|2-Sided|95.0|-0.31|-0.04||E-RS Chest Symptoms Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24||
1593676|NCT03034915|2929873|Other||Mean Difference (Net)|-0.05|Standard Error of the Mean|0.063|<|0.391|2-Sided|95.0|-0.18|0.07||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.||
1593677|NCT03034915|2929873|Other||Mean Difference (Net)|-0.13|Standard Error of the Mean|0.063|<|0.042|2-Sided|95.0|-0.25|0.0||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24.||
1593678|NCT03034915|2929873|Other||Mean Difference (Net)|-0.07|Standard Error of the Mean|0.063|<|0.247|2-Sided|95.0|-0.2|0.05||E-RS Cough and Sputum Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24.||
1593679|NCT03034915|2929873|Other||Mean Difference (Net)|-0.18|Standard Error of the Mean|0.115|<|0.115|2-Sided|95.0|-0.41|0.04||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24.||
1593829|NCT03019627|2930487|Superiority||Difference in least square means|-0.7|||=|0|2-Sided|95.0|-1.38|-0.01|||ANCOVA|||week 4|
1593680|NCT03034915|2929873|Other||Mean Difference (Net)|-0.46|Standard Error of the Mean|0.113|<|0.001|2-Sided|95.0|-0.68|-0.23||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24.||
1593681|NCT03034915|2929873|Other||Mean Difference (Net)|-0.27|Standard Error of the Mean|0.114|<|0.016|2-Sided|95.0|-0.5|-0.05||E-RS Breathlessness Score|Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24.||
1593682|NCT03034915|2929874|Other||Mean Difference (Net)|-0.3|Standard Error of the Mean|0.214||0.159|2-Sided|95.0|-0.72|0.12|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 21 to Week 24||
1593683|NCT03034915|2929874|Other||Mean Difference (Net)|-0.83|Standard Error of the Mean|0.211|<|0.001|2-Sided|95.0|-1.25|-0.42|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 21 to Week 24..||
1593684|NCT03034915|2929874|Other||Mean Difference (Net)|-0.53|Standard Error of the Mean|0.213|<|0.013|2-Sided|95.0|-0.95|-0.11|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 21 to Week 24||
1593685|NCT03034915|2929875|Other||Odds Ratio (OR)|1.03||||0.755|2-Sided|95.0|0.84|1.27|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC versus salmeterol at Week 24.||
1593686|NCT03034915|2929875|Other||Odds Ratio (OR)|1.48|||<|0.001|2-Sided|95.0|1.21|1.81|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI versus salmeterol at Week 24||
1593687|NCT03034915|2929875|Other||Odds Ratio (OR)|1.43|||<|0.001|2-Sided|95.0|1.17|1.75|||generalized linear mixed model||Odds Ratio (responder vs. a non-responder) comparing UMEC/VI vs UMEC at Week 24||
1593688|NCT03034915|2929876|Other||Mean Difference (Net)|0.08|Standard Error of the Mean|0.159||0.61|2-Sided|95.0|-0.23|0.39|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24||
1593689|NCT03034915|2929876|Other||Mean Difference (Net)|0.45|Standard Error of the Mean|0.155||0.004|2-Sided|95.0|0.15|0.76|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.||
1593690|NCT03034915|2929876|Other||Mean Difference (Net)|0.37|Standard Error of the Mean|0.157||0.018|2-Sided|95.0|0.06|0.68|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.||
1593691|NCT03034915|2929877|Other||Mean Difference (Net)|0.075|Standard Error of the Mean|0.0119|<|0.001|2-Sided|95.0|0.051|0.098|||Mixed model repeated measures||LS Mean difference comparing UMEC versus salmeterol at Week 24.||
1593692|NCT03034915|2929877|Other||Mean Difference (Net)|0.141|Standard Error of the Mean|0.0117|<|0.001|2-Sided|95.0|0.118|0.164|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus salmeterol at Week 24.||
1593693|NCT03034915|2929877|Other||Mean Difference (Net)|0.066|Standard Error of the Mean|0.0118|<|0.001|2-Sided|95.0|0.043|0.089|||Mixed model repeated measures||LS Mean difference comparing UMEC/VI versus UMEC at Week 24.||
1593694|NCT03032965|2929924|Superiority|||||||0.09|||||||t-test, 2 sided||||
1593695|NCT03032965|2929926|Superiority|||||||0.35|||||||t-test, 2 sided||||
1593696|NCT03032965|2929927|Superiority|||||||0.83|||||||Log Rank|Kaplan Meier log rank|||
1593697|NCT03031899|2929941|Non-Inferiority|"Rose bengal should stain the areas positively stained by Toluidine blue~areas stained by rose bengal that shows dysplasia in biopsy"||||||0.005|||||||Chi-squared||||
1593698|NCT03031795|2929942|Superiority||||||<|0.05||||||The a priori threshold for statistical significance was set at < 0.05 for each row comparison with no adjustment for multiple comparisons.|Wilcoxon rank sum test|||A 2 point difference was used to power the study. This is consistent with previous definitions of a clinically meaningful reductions in pain and provides a visually meaningful change on the 0-10 numerical rating scale with anchors at every other point, for example moving from “very severe” (8) to “severe pain” (6) or from “moderate pain” (4) to “mild pain” (2).|
1593699|NCT03031496|2929956|Other||Least square mean ratio|101.47|||||2-Sided|90.0|97.84|105.23|||||Comparison of Tmax of amiloride for test and reference product has been presented.||
1593700|NCT03031496|2929956|Equivalence|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|92.37|||||2-Sided|90.0|88.75|96.12|||||Comparison of Tmax of hydrochlorothiazide for test and reference product has been presented.||
1593701|NCT03031496|2929957|Equivalence|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|103.92|||||2-Sided|90.0|97.42|110.86|||||Comparison of Cmax of amiloride for test and reference product has been presented.||
1593702|NCT03031496|2929957|Equivalence|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|82.86|||||2-Sided|90.0|77.37|88.74|||||Comparison of Cmax of hydrochlorothiazide for test and reference product has been presented.||
1593703|NCT03031496|2929958|Equivalence|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|102.42|||||2-Sided|90.0|98.12|106.91|||||Comparison of AUC (0-t) of amiloride for test and reference product has been presented.||
1593704|NCT03031496|2929958|Equivalence|Bioequivalence of hydrochlorothiazide and amiloride hydrochloride was determined.|Least square mean ratio|91.52|||||2-Sided|90.0|87.77|95.43|||||Comparison of AUC (0-t) of hydrochlorothiazide for test and reference product has been presented.||
1593705|NCT03029819|2930001|Superiority|||||||0.52|||||||Chi-squared||||
1593706|NCT03029234|2930037|Other|The prespecified threshold that the primary endpoint would be met was if the lower limit of the 95% confidence interval (CI) was greater than 18%.|Overall response rate|35.8|||||2-Sided|95.0|27.3|44.9|||||||
1593707|NCT03028467|2930075|Other||Mean Difference (Net)|-0.7932|||||2-Sided|95.0|-2.708|1.1217|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593708|NCT03028467|2930075|Other||Mean Difference (Net)|0.5415|||||2-Sided|95.0|-1.381|2.4639|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593709|NCT03028467|2930075|Other||Mean Difference (Net)|-1.4276|||||2-Sided|95.0|-3.6569|0.8018|||||Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593710|NCT03028467|2930075|Other||Mean Difference (Net)|-0.1181|||||2-Sided|95.0|-2.4643|2.2281|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593711|NCT03028467|2930075|Other||Mean Difference (Net)|0.1851|||||2-Sided|95.0|-2.1704|2.5407|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593712|NCT03028467|2930075|Other||Mean Difference (Net)|-0.3576|||||2-Sided|95.0|-3.0892|2.374|||||Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593713|NCT03028467|2930075|Other||Mean Difference (Net)|-0.9665|||||2-Sided|95.0|-3.0984|1.1654|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593714|NCT03028467|2930075|Other||Mean Difference (Net)|-0.5499|||||2-Sided|95.0|-2.6903|1.5904|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593715|NCT03028467|2930075|Other||Mean Difference (Net)|-0.6521|||||2-Sided|95.0|-3.1342|1.83|||||Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593716|NCT03028467|2930075|Other||Mean Difference (Net)|-0.4593|||||2-Sided|95.0|-2.161|1.2424|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593717|NCT03028467|2930075|Other||Mean Difference (Net)|-0.1876|||||2-Sided|95.0|-1.896|1.5209|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593718|NCT03028467|2930075|Other||Mean Difference (Net)|-0.3209|||||2-Sided|95.0|-2.3021|1.6603|||||Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593719|NCT03028467|2930075|Other||Mean Difference (Net)|-1.1615|||||2-Sided|95.0|-3.0028|0.6799|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593720|NCT03028467|2930075|Other||Mean Difference (Net)|-0.8894|||||2-Sided|95.0|-2.7381|0.9593|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593721|NCT03028467|2930075|Other||Mean Difference (Net)|-1.4575|||||2-Sided|95.0|-3.6013|0.6863|||||Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593722|NCT03028467|2930075|Other||Mean Difference (Net)|-0.8047|||||2-Sided|95.0|-2.3045|0.6951|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593723|NCT03028467|2930075|Other||Mean Difference (Net)|-0.8905|||||2-Sided|95.0|-2.3962|0.6153|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593724|NCT03028467|2930075|Other||Mean Difference (Net)|-1.1387|||||2-Sided|95.0|-2.8848|0.6075|||||Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593725|NCT03028467|2930075|Other||Mean Difference (Net)|-0.5332|||||2-Sided|95.0|-1.914|0.8475|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593726|NCT03028467|2930075|Other||Mean Difference (Net)|-0.5177|||||2-Sided|95.0|-1.904|0.8685|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593727|NCT03028467|2930075|Other||Mean Difference (Net)|-1.111|||||2-Sided|95.0|-2.7186|0.4965|||||Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.||
1593728|NCT03028363|2930090|Other|||||||0.5247|||||||Regression, Logistic|Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation|||
1593729|NCT03028363|2930091|Other|||||||0.126|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation|||
1593730|NCT03028363|2930092|Other|||||||0.343|||||||ANCOVA|Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation|||
1593731|NCT03028220|2930095|Other|||||||0.191|||||||Wilcoxon (Mann-Whitney)||||
1593732|NCT03028220|2930096|Other|||||||0.46|||||||Wilcoxon (Mann-Whitney)||||
1593733|NCT03028220|2930097|Other|||||||0.91|||||||Wilcoxon (Mann-Whitney)||||
1593734|NCT03028220|2930098|Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1593735|NCT03028220|2930099|Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)||||
1593736|NCT03028220|2930100|Other|||||||0.82|||||||Wilcoxon (Mann-Whitney)||||
1593737|NCT03028220|2930101|Other|||||||0.82|||||||Wilcoxon (Mann-Whitney)||||
1593738|NCT03028220|2930102|Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1593739|NCT03028220|2930103|Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1593740|NCT03028220|2930104|Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1593741|NCT03028220|2930105|Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1593742|NCT03028220|2930106|Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1593743|NCT03028142|2930107|Other||LS Means ratio|1.04||||0.0228|2-Sided|95.0|1.01|1.08|||ANCOVA||||
1593744|NCT03028142|2930107|Other||LS Means ratio|1.03||||0.1404|2-Sided|95.0|0.99|1.06|||ANCOVA||||
1593751|NCT03026556|2930117|Other||Hazard Ratio (HR)|1.024||||0.8947|2-Sided|95.0|0.716|1.465|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593752|NCT03026556|2930117|Other||Hazard Ratio (HR)|1.008||||0.9359|2-Sided|95.0|0.829|1.226|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593753|NCT03026556|2930118|Other||Hazard Ratio (HR)|1.557||||0.3333|2-Sided|95.0|0.635|3.821|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593754|NCT03026556|2930118|Other||Hazard Ratio (HR)|1.346||||0.2309|2-Sided|95.0|0.828|2.189|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593755|NCT03026556|2930119|Other||Hazard Ratio (HR)|1.721||||0.0275|2-Sided|95.0|1.062|2.79|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593756|NCT03026556|2930119|Other||Hazard Ratio (HR)|0.923||||0.4727|2-Sided|95.0|0.741|1.149|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593757|NCT03026556|2930120|Other||Hazard Ratio (HR)|1.138||||0.7115|2-Sided|95.0|0.573|2.26|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593758|NCT03026556|2930120|Other||Hazard Ratio (HR)|0.766||||0.1227|2-Sided|95.0|0.546|1.075|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593759|NCT03026556|2930121|Other||Hazard Ratio (HR)|0.864||||0.8112|2-Sided|95.0|0.261|2.863|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593760|NCT03026556|2930121|Other||Hazard Ratio (HR)|0.709||||0.2663|2-Sided|95.0|0.387|1.299|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593761|NCT03026556|2930123|Other||Hazard Ratio (HR)|1.504||||0.0417|2-Sided|95.0|1.015|2.228|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593762|NCT03026556|2930123|Other||Hazard Ratio (HR)|0.887||||0.2073|2-Sided|95.0|0.736|1.069|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593763|NCT03026556|2930124|Other||Hazard Ratio (HR)|1.431||||0.0616|2-Sided|95.0|0.983|2.083|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593764|NCT03026556|2930124|Other||Hazard Ratio (HR)|0.856||||0.0901|2-Sided|95.0|0.716|1.025|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593765|NCT03026556|2930125|Other||Hazard Ratio (HR)|1.11||||0.8124|2-Sided|95.0|0.469|2.63|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593766|NCT03026556|2930125|Other||Hazard Ratio (HR)|0.654||||0.0406|2-Sided|95.0|0.435|0.982|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593767|NCT03026556|2930126|Other||Hazard Ratio (HR)|0.223||||0.0023|2-Sided|95.0|0.085|0.585|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593768|NCT03026556|2930127|Other||Hazard Ratio (HR)|1.054||||0.8777|2-Sided|95.0|0.54|2.055|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593769|NCT03026556|2930127|Other||Hazard Ratio (HR)|0.923||||0.6307|2-Sided|95.0|0.667|1.278|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593770|NCT03026556|2930128|Other||Hazard Ratio (HR)|1.374||||0.0702|2-Sided|95.0|0.974|1.939|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593771|NCT03026556|2930128|Other||Hazard Ratio (HR)|0.82||||0.0182|2-Sided|95.0|0.696|0.967|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593772|NCT03026556|2930129|Other||Hazard Ratio (HR)|1.255||||0.4892|2-Sided|95.0|0.659|2.39|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593773|NCT03026556|2930129|Other||Hazard Ratio (HR)|0.766||||0.0844|2-Sided|95.0|0.566|1.037|||Regression, Cox|||Cox proportional-hazards regression analysis was used to compute Hazard ratios (HR) and corresponding 95% confidence intervals (CI).|
1593774|NCT03026257|2930132|Superiority||||||<|0.0001|||||||General Linear Model||||
1593775|NCT03026257|2930132|Superiority||||||<|0.0001|||||||General Linear Model||||
1593776|NCT03026257|2930132|Superiority||||||<|0.0001|||||||General Linear Model||||
1593777|NCT03026257|2930132|Superiority||||||<|0.0001|||||||General Linear Model||||
1593778|NCT03026257|2930132|Superiority||||||<|0.0001|||||||General Linear Model||||
1593779|NCT03026257|2930132|Superiority||||||<|0.0001|||||||General Linear Model||||
1593780|NCT03026257|2930132|Superiority||||||<|0.0001|||||||General Linear Model||||
1593781|NCT03026257|2930132|Superiority||||||<|0.0001|||||||General Linear Model||||
1593830|NCT03019627|2930488|Superiority||difference in least square means|-13.8|||=|0|2-Sided|95.0|-23.7|3.88|||ANCOVA|||Severity statistical analysis - week 12|
1593831|NCT03019627|2930488|Superiority||difference in least square means|1.06|||=|0|2-Sided|95.0|-9.12|11.24|||ANCOVA|||Severity statistical analysis - week 8|
1597179|NCT02915835|2935799|Superiority|||||||1|||||||Fisher Exact||||
1593782|NCT03026075|2930154|Superiority||||||<|0.01|||||||McNemar|||"The primary objective of the study is to evaluate the effectiveness of MCS in cleansing a poorly prepared colon.~A sample size of 47 patients is required as per a McNemar test to determine that the paired discordant proportions are significantly different under the followings assumptions:~Probability of Type I Error (α) = 0.05, Power (1 - β) = 0.8 Proportion switching from + to - = 0, Proportion switching from - to + = 0.6 Potential of dropout 10% (i.e. 4 cases)"|
1593783|NCT03025217|2930156|Other||Cohen's d|0.75||||0.001|2-Sided||||||t-test, 2 sided||||
1593784|NCT03025217|2930157|Other||Cohen's d|0.33||||0.095|2-Sided||||||t-test, 2 sided||||
1593785|NCT03024112|2930162|Other|||||||0.68|||||||t-test, 1 sided||||
1593786|NCT03023423|2930202|Superiority||Odds Ratio (OR)|0.3|||||2-Sided|95.0|0.03|1.92|||||||
1593787|NCT03021668|2930276|Equivalence|Students' T-test was used to evaluate any difference in length of stay between the two groups.||||||0.23|||||||t-test, 2 sided||||
1593788|NCT03021668|2930277|Equivalence|Chi2 test was performed to analyze difference in rates of Surgical Site Infections (SSIs) between the two groups||||||0.003|||||||Chi-squared||||
1593789|NCT03021642|2930291|Superiority or Other||Median Difference (Net)|0.0||||0.8981|2-Sided|90.0|-1.0|1.025|||Wilcoxon signed-rank test||||
1593790|NCT03021642|2930292|Superiority or Other||Geometric LS mean ratio|96.88|||||2-Sided|90.0|90.8|103.36|||||||
1593791|NCT03021642|2930293|Superiority or Other||Geometric LS mean ratio|95.71|||||2-Sided|90.0|88.43|103.59|||||||
1593792|NCT03021642|2930294|Superiority or Other||Geometric Least square (LS) mean ratio|98.68|||||2-Sided|90.0|93.67|103.96|||||||
1593793|NCT03021187|2930317|Superiority||Hazard Ratio (HR)|0.48||||0.0006|2-Sided|95.0|0.31|0.73||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1593794|NCT03021187|2930317|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.48||||0.0007|2-Sided|95.0|0.32|0.74||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1593795|NCT03021187|2930317|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.75||||0.121|2-Sided|95.0|0.53|1.08||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1593796|NCT03021187|2930318|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.57||||0.0019|2-Sided|95.0|0.4|0.81||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1593797|NCT03021187|2930318|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.63||||0.0083|2-Sided|95.0|0.44|0.89||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1593798|NCT03021187|2930318|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.73||||0.0627|2-Sided|95.0|0.53|1.02||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1593799|NCT03021187|2930338|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-3.7|||<|0.0001|2-Sided|95.0|-4.4|-3.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1593800|NCT03021187|2930338|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-2.5|||<|0.0001|2-Sided|95.0|-3.2|-1.8||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1593832|NCT03019627|2930488|Superiority||difference in least square means|2.55|||=|0|2-Sided|95.0|-5.72|10.82|||ANCOVA|||Severity statistical analysis - week 4|
1597180|NCT02915835|2935800|Superiority|||||||1|||||||Fisher Exact||||
1593801|NCT03021187|2930338|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.9|||<|0.0111|2-Sided|95.0|-1.6|-0.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1593802|NCT03021187|2930338|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-3.3|||<|0.0001|2-Sided|95.0|-4.2|-2.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1593803|NCT03021187|2930338|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.0|||<|0.0001|2-Sided|95.0|-3.0|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1593804|NCT03021187|2930338|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0392|2-Sided|95.0|-1.8|0.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1593805|NCT03021187|2930339|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.4|||<|0.0001|2-Sided|95.0|-1.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1593806|NCT03021187|2930339|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.0|||<|0.0001|2-Sided|95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and the interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1593807|NCT03021187|2930339|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|2-Sided|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, region, strata and interaction strata as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1593833|NCT03019627|2930488|Superiority||difference in least square means|-15.3|||=|0|2-Sided|95.0|-25.6|-4.97|||ANCOVA|||Frequency statistical analysis - week 12|
1593834|NCT03019627|2930488|Superiority||difference in least square means|-3.82|||=|0|2-Sided|95.0|-14.1|6.41|||ANCOVA|||Frequency statistical analysis - week 8|
1593835|NCT03019627|2930488|Superiority||Difference in least square means|-1.12|||=|0|2-Sided|95.0|-9.14|6.91|||ANCOVA|||frequency statistical analysis - week 4|
1593836|NCT03019627|2930489|Superiority||difference in least square means|0.16|||=|0|2-Sided|95.0|-9.45|9.76|||ANCOVA|||Severity statistical analysis|
1608206|NCT02610868|2953672|Superiority||||||<|0.0001|||||||ANCOVA||||
1593808|NCT03021187|2930339|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.2|||<|0.0001|2-Sided|95.0|-1.4|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1593809|NCT03021187|2930339|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0001|2-Sided|95.0|-1.1|-0.7||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1593810|NCT03021187|2930339|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.5|||<|0.0001|2-Sided|95.0|-0.7|-0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, interaction strata and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1593811|NCT03020719|2930411|Superiority||Rate Ratio|0.12||||0.0122|2-Sided|95.0|0.01|0.67|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the GSH group was 179.22 and in the Placebo group was 177.19.|
1593812|NCT03020719|2930411|Superiority||Rate Ratio|1.21||||0.1087|2-Sided|95.0|0.96|1.52|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the GSH group was 179.22 and in the Placebo group was 177.19.|
1593813|NCT03020719|2930412|Superiority||Difference in % of Participants with SAE|-13.3||||0.1945|2-Sided|95.0|-30.5|2.9|||Fisher Exact||95% CI calculated using the Newcombe-Wilson method without continuity correction.||
1593814|NCT03020719|2930412|Superiority||Difference in % of Participants with AE|0.0||||1|2-Sided|95.0|-13.6|13.6|||Fisher Exact||95% CI calculated using the Newcombe-Wilson method without continuity correction.||
1593815|NCT03020719|2930413|Superiority||Mean Difference (Final Values)|-0.55||||0.4666|2-Sided|95.0|-2.06|0.96|||ANCOVA|Model adjusted for randomization strata: sex, baseline age (<6 years, ≥6 years), and baseline weight-for-age z-score category (< -0.52, ≥-0.52).|||
1593816|NCT03020719|2930414|Superiority||Mean Difference (Final Values)|0.11||||0.4259|2-Sided|95.0|-0.17|0.4|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (<6 years, ≥6 years), and baseline weight-for-age z-score category (< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.||
1593817|NCT03020719|2930415|Superiority||Mean Difference (Final Values)|-0.06||||0.573|2-Sided|95.0|-0.28|0.15|||Mixed Models Analysis|Model adjusted from randomization strata: sex, baseline age (<6 years, ≥6 years), and baseline weight-for-age z-score category (< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.||
1593818|NCT03020719|2930416|Superiority||Mean Difference (Final Values)|-0.08||||0.089|2-Sided|95.0|-0.18|0.01|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (<6 years, ≥6 years), and baseline weight-for-age z-score category (< -0.52, ≥-0.52).|Model incorporates Week 12 measurements, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.||
1593819|NCT03020719|2930417|Superiority||Mean Difference (Final Values)|-0.081||||0.2521|2-Sided|95.0|-0.221|0.059|||Mixed Models Analysis|Model adjusted for randomization strata: sex, baseline age (< 6 years, ≥ 6 years), and baseline weight-for-age z-score category (< -0.52, ≥ -0.52).|Model incorporates Week 12 weight-for-age z-score, assumes unstructured covariance for within-subject measurements, and includes a subject-level random intercept.||
1593820|NCT03019627|2930484|Superiority||Difference in least square means|5.75|||=|0|2-Sided|95.0|2.02|9.48|||ANCOVA||||
1593821|NCT03019627|2930485|Superiority||Difference in least square means|-0.12|||=|0|2-Sided|95.0|-0.76|0.52|||ANCOVA|||week 12|
1593822|NCT03019627|2930485|Superiority||Difference in least square means|0.03|||=|0|2-Sided|95.0|-0.55|0.62|||ANCOVA|||week 8|
1593823|NCT03019627|2930485|Superiority||Difference in least square means|-0.25|||=|0|2-Sided|95.0|-0.76|0.25|||ANCOVA|||week 4|
1593824|NCT03019627|2930486|Superiority||Difference in least square means|-0.6|||=|0|2-Sided|95.0|-1.9|0.7|||ANCOVA|||week 12|
1593825|NCT03019627|2930486|Superiority||Difference in least square means|-1.38|||=|0|2-Sided|95.0|-2.59|-0.17|||ANCOVA|||week 8|
1593826|NCT03019627|2930486|Superiority||Difference in least square means|-0.71|||=|0|2-Sided|95.0|-1.95|0.54|||ANCOVA|||week 4|
1593827|NCT03019627|2930487|Superiority||Difference in least square means|-0.09|||=|0|2-Sided|95.0|-0.76|0.58|||ANCOVA|||week 12|
1593837|NCT03019627|2930489|Superiority||difference in least square means|-3.83|||=|0|2-Sided|95.0|-13.34|5.68|||ANCOVA|||Frequency statistical analysis|
1593838|NCT03019458|2930496|Superiority|||||||0.084||||||The p value was not adjusted for multiple comparisons but rather it is the priori threshold for statistical significance at p<0.05.|Mixed Models Analysis|We adjusted for baseline Eating Assessment Tool-10 (EAT-10), MGH-Swallowing Screening Test (MGH-SST), and the Burkes-Fahn-Marsden Dysonia Scale (BFM).|||
1593839|NCT03018938|2930497|Superiority||LS Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.33||0.7553|2-Sided|95.0|-0.8|0.5|||Mixed Models Analysis||||
1593840|NCT03018938|2930498|Superiority||Odds Ratio (OR)|1.05||||0.8054|2-Sided|95.0|0.72|1.53|||Regression, Logistic||||
1593841|NCT03018938|2930499|Superiority||Odds Ratio (OR)|1.25||||0.2009|2-Sided|95.0|0.89|1.77|||Regression, Logistic||||
1593842|NCT03018938|2930502|Superiority||LS Mean Difference (Final Values)|0.754|Standard Error of the Mean|0.2864||0.0086|2-Sided|95.0|0.192|1.316|||ANCOVA||||
1593843|NCT03018938|2930503|Superiority||LS Mean Difference|0.667|Standard Error of the Mean|0.2776||0.0166|2-Sided|95.0|0.122|1.211|||ANCOVA||||
1593844|NCT03018938|2930505|Superiority||LS Mean Difference (Final Values)|-0.013|Standard Error of the Mean|0.3028||0.9661|2-Sided|95.0|-0.608|0.582|||ANCOVA|||PPG|
1593845|NCT03018938|2930505|Superiority||LS Mean Difference (Final Values)|0.491|Standard Error of the Mean|0.2033||0.016|2-Sided|95.0|0.092|0.891|||ANCOVA|||FBG|
1593846|NCT03018938|2930506|Superiority||LS Mean Difference (Final Values)|-0.084|Standard Error of the Mean|0.3331||0.8014|2-Sided|95.0|-0.739|0.571|||ANCOVA|||PPG|
1593847|NCT03018938|2930506|Superiority||LS Mean Difference (Final Values)|0.27|Standard Error of the Mean|0.2191||0.2193|2-Sided|95.0|-0.161|0.7|||ANCOVA|||FBG|
1593848|NCT03018938|2930507|Superiority||LS Mean Difference (Final Values)|0.647|Standard Error of the Mean|0.1955||0.001|2-Sided|95.0|0.263|1.031|||ANCOVA||||
1593849|NCT03018938|2930508|Superiority||LS Mean Difference (Final Values)|0.423|Standard Error of the Mean|0.2152||0.0497|2-Sided|95.0|0.0|0.846|||ANCOVA||||
1593850|NCT03018938|2930509|Superiority||Odds Ratio (OR)|1.03||||0.8592|2-Sided|95.0|0.72|1.49|||Regression, Logistic||||
1593851|NCT03018938|2930510|Superiority||Odds Ratio (OR)|1.34||||0.0941|2-Sided|95.0|0.95|1.87|||Regression, Logistic||||
1593852|NCT03018938|2930511|Superiority||LS Mean Difference (Final Values)|-0.201|Standard Error of the Mean|0.0891||0.0246|2-Sided|95.0|-0.376|-0.026|||ANCOVA||||
1593853|NCT03018938|2930512|Non-Inferiority|If Lower limit (L) >-0.4%, the Non-inferiority (NI) of basal insulin analog QD to insulin analog mid mixture BID is established; If Upper limit (U) <0.4%, the NI of insulin analog mid mixture BID to basal insulin analog QD is established|LS Mean Difference (Final Values)|-0.158|Standard Error of the Mean|0.0959||0.1009|2-Sided|95.0|-0.346|0.031|||ANCOVA||||
1593854|NCT03018340|2930523|Superiority||Difference in MMRM LSMs|0.5|Standard Error of the Mean|1.3||0.694|2-Sided|95.0|-2.1|3.1|||Mixed Models Analysis||||
1593855|NCT03018340|2930523|Superiority||Difference in MMRM LSMs|-4.0|Standard Error of the Mean|1.09||0.0003|2-Sided|95.0|-6.1|-1.9|||Mixed Models Analysis||||
1593856|NCT03018340|2930523|Superiority||Difference in weighted MMRM LSMs|-1.7|Standard Error of the Mean|0.85||0.039|2-Sided|95.0|-3.4|-0.1|||Mixed Models Analysis|||This is the primary statistical comparison for Stage 1 and Stage 2 combined.|
1593857|NCT03018028|2930554|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.97||||0.3765|2-Sided|95.0|0.44|8.85||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 14 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1593858|NCT03018028|2930554|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.31||||0.7147|2-Sided|95.0|0.31|5.56||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 7 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1593859|NCT03018028|2930554|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|2.95||||0.1193|2-Sided|95.0|0.76|11.46||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 3 mg / Liraglutide 0.9 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1593860|NCT03018028|2930554|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.23||||0.0098|2-Sided|95.0|0.07|0.7||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1593861|NCT03018028|2930554|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.15||||0.0005|2-Sided|95.0|0.05|0.44||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1593862|NCT03018028|2930554|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.34||||0.0219|2-Sided|95.0|0.14|0.86||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1593891|NCT03014674|2930741|Equivalence|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).|Ratio|1.02|||||2-Sided|90.0|0.95|1.09|||||Ratio (safety syringe/lyophilized drug) for AUC(0-inf) has been presented||
1593863|NCT03018028|2930555|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.33||||0.6498|2-Sided|95.0|0.38|4.62||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1593864|NCT03018028|2930555|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.07||||0.9087|2-Sided|95.0|0.32|3.54||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1593865|NCT03018028|2930555|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|2.7||||0.0674|2-Sided|95.0|0.93|7.8||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Liraglutide 0.9 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1593866|NCT03018028|2930555|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.31||||0.0259|2-Sided|95.0|0.11|0.87||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1593867|NCT03018028|2930555|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.25||||0.0052|2-Sided|95.0|0.1|0.66||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1593868|NCT03018028|2930555|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.63||||0.2579|2-Sided|95.0|0.29|1.4||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1593869|NCT03018028|2930582|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.4||||0.0077|2-Sided|95.0|-0.7|-0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin’s rule to draw inference.|
1593870|NCT03018028|2930582|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.2||||0.1868|2-Sided|95.0|-0.5|0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 7 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin’s rule to draw inference.|
1593871|NCT03018028|2930582|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|0.2||||0.1958|2-Sided|95.0|-0.1|0.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 3 mg - Liraglutide 0.9 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin’s rule to draw inference.|
1593890|NCT03015220|2930671|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.5||||0.2963|2-Sided|95.0|0.7|3.2||Unadjusted two-sided p-value for the test of no difference from 1.|Regression, Cox||"Oral Semaglutide 3 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1610769|NCT02544607|2958779|Other|||||||0.038|||||||t-test, 2 sided||||
1593872|NCT03018028|2930582|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.4|||<|0.0001|2-Sided|95.0|-1.7|-1.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin’s rule to draw inference.|
1593873|NCT03018028|2930582|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.2|||<|0.0001|2-Sided|95.0|-1.5|-0.9||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin’s rule to draw inference.|
1593874|NCT03018028|2930582|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.8|||<|0.0001|2-Sided|95.0|-1.1|-0.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and stratification factor as categorical fixed effects and baseline HbA1c as a covariate for each of the 1000 imputed complete data sets, and pooled by Rubin’s rule to draw inference.|
1593875|NCT03018028|2930582|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.3|||<|0.0272|2-Sided|95.0|-0.6|0.0||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurement||Oral semaglutide 14 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1593876|NCT03018028|2930582|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.1|||<|0.3942|2-Sided|95.0|-0.4|0.2||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 7 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1593877|NCT03018028|2930582|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|0.3|||<|0.0799|2-Sided|95.0|0.0|0.6||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 3 mg - Liraglutide 0.9 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1593878|NCT03018028|2930582|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.7|||<|0.0001|2-Sided|95.0|-2.0|-1.4||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1593879|NCT03018028|2930582|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.5|||<|0.0001|2-Sided|95.0|-1.7|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1593880|NCT03018028|2930582|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.1|||<|0.0001|2-Sided|95.0|-1.4|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide 3 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and stratification factor as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1593881|NCT03017235|2930643|Non-Inferiority|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to colon cleansing in preparation for colonoscopy.|Difference in percentage|3.5||||0.0391|2-Sided|95.0|0.2|6.7||The above p-value was for superiority and was based on the stratified percentage difference, where the stratification weight is based on Cochran-Mantel-Haenszel weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC-PREPOPIK®)|
1593882|NCT03017235|2930644|Non-Inferiority|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.|Difference in percentage|1.9||||0.1781|2-Sided|95.0|-0.9|4.7||The above p-value was tested for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran Mantel Haenszel weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC – PREPOPIK)|
1593883|NCT03017235|2930645|Non-Inferiority|If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.|Difference in percentage|4.6||||0.0099|2-Sided|95.0|1.1|8.0||The p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)|
1593884|NCT03017235|2930646|Non-Inferiority|The NI margin for the difference between treatments (NaP/MC Oral Solution minus PREPOPIK) was pre-specified at -8% (absolute). If NI was demonstrated for both the primary efficacy endpoint and the secondary efficacy endpoint for the right colon, and if the lower bound of the CI was above 0%, then superiority was declared for the primary endpoint. Thus, the pre-specified superiority analysis was conducted at a one-sided significance level of 2.5%.|Difference in percentage|6.3||||0.0067|2-Sided|95.0|1.8|10.9||The above p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.|Weighted Percentage Difference|CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site||Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC – PREPOPIK)|Lower limit of 95% CI > 0% for the primary efficacy endpoint combined with outcome of secondary efficacy endpoint for the right colon allowed for superiority analysis.
1593885|NCT03015220|2930670|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.12||||0.011|2-Sided|95.0|0.02|0.62||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 14 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1593886|NCT03015220|2930670|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.6||||0.3391|2-Sided|95.0|0.21|1.72||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 7 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1593887|NCT03015220|2930670|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.9||||0.1672|2-Sided|95.0|0.76|4.72||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 3 mg~/Dulaglutide 0.75 mg"|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1593888|NCT03015220|2930671|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.55||||0.1871|2-Sided|95.0|0.23|1.33||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||"Oral Semaglutide 14 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1593889|NCT03015220|2930671|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.8||||0.5997|2-Sided|95.0|0.35|1.83||Unadjusted two-sided p-value for the test of no difference from 1.|Regression, Cox||"Oral Semaglutide 7 mg~/Dulaglutide 0.75 mg"|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and strata as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1593927|NCT03012334|2930795|Superiority||LS Mean|26.1|||<|0.0001|2-Sided|95.0|20.0635|32.1953|||Mixed Models Analysis||||
1610770|NCT02544607|2958780|Other|||||||0.0499|||||||t-test, 2 sided||||
1593892|NCT03014674|2930741|Equivalence|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-inf).|Ratio|1.07|||||2-Sided|90.0|1.0|1.13|||||Ratio (autoinjector/lyophilized drug) for AUC(0-inf) has been presented||
1593893|NCT03014674|2930741|Equivalence|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t).|Ratio|1.04|||||2-Sided|90.0|0.97|1.12|||||Ratio (safety syringe/lyophilized drug) for AUC(0-t) has been presented||
1593894|NCT03014674|2930741|Equivalence|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for AUC (0-t)|Ratio|1.08|||||2-Sided|90.0|1.01|1.15|||||Ratio (autoinjector/lyophilized drug) for AUC(0-t) has been presented||
1593895|NCT03014674|2930742|Equivalence|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% CI for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.|Ratio|1.06|||||2-Sided|90.0|0.99|1.12|||||Ratio (safety syringe/lyophilized drug) for Cmax has been presented||
1593896|NCT03014674|2930742|Equivalence|Interpretation of the comparability of the autoinjector and safety syringe with the reconstituted lyophilized drug product was guided by a two-sided 90% confidence interval (CI) for the ratio of the geometric mean of test treatment to reference treatment in the range (0.80, 1.25) for Cmax.|Ratio|1.04|||||2-Sided|90.0|0.98|1.11|||||Ratio (autoinjector/lyophilized drug) for Cmax has been presented||
1593897|NCT03014479|2930757|Superiority||Differences of Least Square Means|0.613||||0.5451|2-Sided|95.0|-1.38|2.605|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors||
1593898|NCT03014479|2930759|Superiority||Differences of Least Square Means|2.696||||0.3533|2-Sided|95.0|-3.018|8.41|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors||
1593899|NCT03014479|2930760|Superiority||Differences of Least Square Means|-0.563||||0.8506|2-Sided|95.0|-6.448|5.323|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors||
1593900|NCT03014479|2930761|Superiority||Differences of Least Square Means|4.16||||0.0896|2-Sided|95.0|-0.649|8.968|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors||
1593901|NCT03014479|2930762|Superiority||Differences of Least Square Means|1.938||||0.4536|2-Sided|95.0|-3.15|7.027|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors||
1593902|NCT03014479|2930763|Superiority||Differences of Least Square Means|2.418||||0.2305|2-Sided|95.0|-1.546|6.382|||ANCOVA||Trelagliptin - Daily DPP-4 inhibitors||
1593903|NCT03012828|2930790|Other|The model was used for predicting population average and 90% 2-sided bootstrapped CI of the baseline-adjusted difference between active and placebo at each time point bound at clinically relevant concentrations.|Slope|-0.0077||||0.4727|2-Sided|90.0|-0.0255|0.0101|||Mixed Models Analysis||The primary mixed effects model analysis revealed a nearly flat dQTcF – plasma concentration gradient|The primary analysis used a mixed-effects model to explore the relationship between the time-matched, baseline-adjusted QTcF (delta (d)QTcF) and moxidectin concentrations. dQTcF was a dependent variable and treatment, time point, and treatment by time point interaction as the independent variables with baseline QTcF as a covariate and time-matched concentrations of moxidectin as a covariate with random effects of intercept and slope for each subject.Concentrations of zero were used for placebo.|
1593904|NCT03012334|2930791|Superiority||LS Mean|-0.232|||<|0.0001|2-Sided|95.0|-0.3261|-0.137|||Mixed Models Analysis||||
1593905|NCT03012334|2930791|Superiority||LS Mean|-0.3|||<|0.0001|2-Sided|95.0|-0.3949|-0.2047|||Mixed Models Analysis||||
1593906|NCT03012334|2930791|Superiority||LS Mean|-0.423|||<|0.0001|2-Sided|95.0|-0.5183|-0.3286|||Mixed Models Analysis||||
1593907|NCT03012334|2930791|Superiority||LS Mean|0.603|||<|0.0001|2-Sided|95.0|0.508|0.6983|||Mixed Models Analysis||||
1593908|NCT03012334|2930791|Superiority||LS Mean|0.372|||<|0.0001|2-Sided|95.0|0.277|0.4662|||Mixed Models Analysis||||
1593909|NCT03012334|2930791|Superiority||LS Mean|0.303|||<|0.0001|2-Sided|95.0|0.2082|0.3985|||Mixed Models Analysis||||
1593910|NCT03012334|2930791|Superiority||LS Mean|0.18|||<|0.0002|2-Sided|95.0|0.0849|0.2746|||Mixed Models Analysis||||
1593911|NCT03012334|2930793|Superiority||LS Mean|0.019||||0.8629|2-Sided|95.0|-0.1995|0.2379|||Mixed Models Analysis||||
1593912|NCT03012334|2930793|Superiority||LS Mean|-0.535|||<|0.0001|2-Sided|95.0|-0.7549|-0.3151|||Mixed Models Analysis||||
1593913|NCT03012334|2930793|Superiority||LS Mean|-1.114|||<|0.0001|2-Sided|95.0|-1.3333|-0.8948|||Mixed Models Analysis||||
1593914|NCT03012334|2930793|Superiority||LS Mean|2.553|||<|0.0001|2-Sided|95.0|2.3331|2.773|||Mixed Models Analysis||||
1593915|NCT03012334|2930793|Superiority||LS Mean|2.572|||<|0.0001|2-Sided|95.0|2.3536|2.7909|||Mixed Models Analysis||||
1593916|NCT03012334|2930793|Superiority||LS Mean|2.018|||<|0.0001|2-Sided|95.0|1.7981|2.238|||Mixed Models Analysis||||
1593917|NCT03012334|2930793|Superiority||LS Mean|1.439|||<|0.0001|2-Sided|95.0|1.2198|1.6583|||Mixed Models Analysis||||
1593918|NCT03012334|2930794|Superiority||LS Mean|2.3|||<|0.007|2-Sided|95.0|0.64|3.93|||Mixed Models Analysis||||
1593919|NCT03012334|2930794|Superiority||LS Mean|4.2|||<|0.001|2-Sided|95.0|2.58|5.88|||Mixed Models Analysis||||
1593920|NCT03012334|2930794|Superiority||LS Mean|6.7|||<|0.001|2-Sided|95.0|5.02|8.31|||Mixed Models Analysis||||
1593921|NCT03012334|2930794|Superiority||LS Mean|-11.2|||<|0.001|2-Sided|95.0|-12.81|-9.51|||Mixed Models Analysis||||
1593922|NCT03012334|2930794|Superiority||LS Mean|-8.9|||<|0.001|2-Sided|95.0|-10.52|-7.23|||Mixed Models Analysis||||
1593923|NCT03012334|2930794|Superiority||LS Mean|-6.9|||<|0.001|2-Sided|95.0|-8.58|-5.28|||Mixed Models Analysis||||
1593924|NCT03012334|2930794|Superiority||LS Mean|-4.5|||<|0.001|2-Sided|95.0|-6.14|-2.85|||Mixed Models Analysis||||
1593925|NCT03012334|2930795|Superiority||LS Mean|5.8||||0.0605|2-Sided|95.0|-0.256|11.8317|||Mixed Models Analysis||||
1593926|NCT03012334|2930795|Superiority||LS Mean|14.7|||<|0.0001|2-Sided|95.0|8.6325|20.804|||Mixed Models Analysis||||
1593928|NCT03012334|2930795|Superiority||LS Mean|-52.6|||<|0.0001|2-Sided|95.0|-58.649|-46.4682|||Mixed Models Analysis||||
1593929|NCT03012334|2930795|Superiority||LS Mean|-46.8|||<|0.0001|2-Sided|95.0|-52.8147|-40.7268|||Mixed Models Analysis||||
1593930|NCT03012334|2930795|Superiority||LS Mean|-37.8|||<|0.0001|2-Sided|95.0|-43.927|-31.7537|||Mixed Models Analysis||||
1593931|NCT03012334|2930795|Superiority||LS Mean|-26.4|||<|0.0001|2-Sided|95.0|-32.4956|-20.3628|||Mixed Models Analysis||||
1593932|NCT03012334|2930795|Superiority||LS Mean|2.0|||<|0.5123|2-Sided|95.0|-4.05|8.1021|||Mixed Models Analysis||||
1593933|NCT03012334|2930795|Superiority||LS Mean|6.1|||<|0.0489|2-Sided|95.0|0.0297|12.2554|||Mixed Models Analysis||||
1593934|NCT03012334|2930795|Superiority||LS Mean|17.8|||<|0.0001|2-Sided|95.0|11.7029|23.8908|||Mixed Models Analysis||||
1593935|NCT03012334|2930795|Superiority||LS Mean|-30.4|||<|0.0001|2-Sided|95.0|-36.5068|-24.277|||Mixed Models Analysis||||
1593936|NCT03012334|2930795|Superiority||LS Mean|-28.4|||<|0.0001|2-Sided|95.0|-34.442|-22.2897|||Mixed Models Analysis||||
1593937|NCT03012334|2930795|Superiority||LS Mean|-24.2|||<|0.0001|2-Sided|95.0|-30.3631|-18.1357|||Mixed Models Analysis||||
1593938|NCT03012334|2930795|Superiority||LS Mean|-12.6|||<|0.0001|2-Sided|95.0|-18.6895|-6.5006|||Mixed Models Analysis||||
1593939|NCT03012334|2930797|Superiority||LS Mean|-0.5||||0.0142|2-Sided|95.0|-0.9642|-0.1081|||Mixed Models Analysis||||
1593940|NCT03012334|2930797|Superiority||LS Mean|-1.1|||<|0.0001|2-Sided|95.0|-1.5574|-0.6956|||Mixed Models Analysis||||
1593941|NCT03012334|2930797|Superiority||LS Mean|-1.8|||<|0.0001|2-Sided|95.0|-2.2137|-1.3546|||Mixed Models Analysis||||
1593942|NCT03012334|2930797|Superiority||LS Mean|3.4|||<|0.0001|2-Sided|95.0|2.9568|3.8193|||Mixed Models Analysis||||
1593943|NCT03012334|2930797|Superiority||LS Mean|2.9|||<|0.0001|2-Sided|95.0|2.4239|3.28|||Mixed Models Analysis||||
1593944|NCT03012334|2930797|Superiority||LS Mean|2.3|||<|0.0001|2-Sided|95.0|1.8306|2.6926|||Mixed Models Analysis||||
1593945|NCT03012334|2930797|Superiority||LS Mean|1.6|||<|0.0001|2-Sided|95.0|1.1744|2.0335|||Mixed Models Analysis||||
1593946|NCT03012334|2930798|Superiority||LS Mean|-1.65||||0.19|2-Sided|95.0|-4.11|0.82|||Mixed Models Analysis||||
1593947|NCT03012334|2930798|Superiority||LS Mean|-7.36|||<|0.001|2-Sided|95.0|-9.84|-4.88|||Mixed Models Analysis||||
1593948|NCT03012334|2930798|Superiority||LS Mean|-12.85|||<|0.001|2-Sided|95.0|-15.32|-10.38|||Mixed Models Analysis||||
1593949|NCT03012334|2930798|Superiority||LS Mean|22.71|||<|0.001|2-Sided|95.0|20.23|25.18|||Mixed Models Analysis||||
1593950|NCT03012334|2930798|Non-Inferiority|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in SDLP between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|21.06|||<|0.001|2-Sided|95.0|18.6|23.52||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis||||
1593951|NCT03012334|2930798|Non-Inferiority|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in SDLP between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|15.35|||<|0.001|2-Sided|95.0|12.87|17.82||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis||||
1593952|NCT03012334|2930798|Non-Inferiority|Doses of lasmiditan were considered non-inferior to placebo if the upper 95% confidence limit on the difference in Standard Deviation of Lateral Position (SDLP) between that dose and placebo was less than 4.4 cm and lower doses also did not exceed the non-inferiority (NI) margin.|LS Mean|9.86|||<|0.001|2-Sided|95.0|7.39|12.33||P-value is obtained from mixed effect model for testing difference versus placebo equals to zero.|Mixed Models Analysis||||
1593953|NCT03012061|2930803|Superiority||Mean Difference (Net)|3.4|Standard Error of the Mean|1.07||0.002|2-Sided|95.0|1.3|5.5|||MMRM||UMEC 62.5 mcg versus Placebo, Week 24||
1593954|NCT03012061|2930803|Superiority||Mean Difference (Net)|1.7|Standard Error of the Mean|0.84||0.045|2-Sided|95.0|0.0|3.3|||MMRM||UMEC 62.5 mcg versus Placebo, Week 12||
1593955|NCT03012061|2930803|Superiority||Mean Difference (Net)|1.4|Standard Error of the Mean|0.97||0.14|2-Sided|95.0|-0.5|3.3|||MMRM||UMEC 62.5 mcg versus Placebo, Week 4||
1593956|NCT03012061|2930803|Superiority||Mean Difference (Net)|1.1|Standard Error of the Mean|1.07||0.3|2-Sided|95.0|-1.0|3.2|||MMRM||UMEC 31.25 mcg versus Placebo, Week 24||
1593957|NCT03012061|2930803|Superiority||Mean Difference (Net)|0.6|Standard Error of the Mean|0.84||0.457|2-Sided|95.0|-1.0|2.3|||MMRM||UMEC 31.25 mcg versus Placebo, Week 12||
1593958|NCT03012061|2930803|Superiority||Mean Difference (Net)|1.3|Standard Error of the Mean|0.97||0.195|2-Sided|95.0|-0.7|3.2|||MMRM||UMEC 31.25 mcg vs Placebo, Week 4||
1593959|NCT03012061|2930804|Superiority||Mean Difference (Net)|1.5|Standard Error of the Mean|0.81||0.066|2-Sided|95.0|-0.1|3.1|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 24||
1593960|NCT03012061|2930804|Superiority||Mean Difference (Net)|1.0|Standard Error of the Mean|0.82||0.204|2-Sided|95.0|-0.6|2.6|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 12||
1593961|NCT03012061|2930804|Superiority||Mean Difference (Net)|0.2|Standard Error of the Mean|0.78||0.779|2-Sided|95.0|-1.3|1.8|||MMRM||UMEC 62.5 mcg versus placebo, DBP, Week 4||
1593962|NCT03012061|2930804|Superiority||Mean Difference (Net)|1.6|Standard Error of the Mean|0.81||0.047|2-Sided|95.0|0.0|3.2|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 24||
1593963|NCT03012061|2930804|Superiority||Mean Difference (Net)|-0.5|Standard Error of the Mean|0.82||0.521|2-Sided|95.0|-2.1|1.1|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 12||
1593964|NCT03012061|2930804|Superiority||Mean Difference (Net)|0.8|Standard Error of the Mean|0.79||0.309|2-Sided|95.0|-0.7|2.3|||MMRM||UMEC 31.25 mcg vs Placebo, DBP, Week 4||
1593965|NCT03012061|2930804|Superiority||Mean Difference (Net)|0.5|Standard Error of the Mean|1.1||0.625|2-Sided|95.0|-1.6|2.7|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 24||
1593966|NCT03012061|2930804|Superiority||Mean Difference (Net)|0.3|Standard Error of the Mean|1.11||0.787|2-Sided|95.0|-1.9|2.5|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 12||
1597181|NCT02915835|2935801|Superiority|||||||1|||||||Fisher Exact||||
1593967|NCT03012061|2930804|Superiority||Mean Difference (Net)|1.0|Standard Error of the Mean|0.99||0.336|2-Sided|95.0|-1.0|2.9|||MMRM||UMEC 62.5 mcg vs Placebo, SBP, Week 4||
1593968|NCT03012061|2930804|Superiority||Mean Difference (Net)|1.7|Standard Error of the Mean|1.1||0.115|2-Sided|95.0|-0.4|3.9|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 24||
1593969|NCT03012061|2930804|Superiority||Median Difference (Net)|-0.5|Standard Error of the Mean|1.11||0.636|2-Sided|95.0|-2.7|1.7|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 12||
1593970|NCT03012061|2930804|Superiority||Median Difference (Net)|1.7|Standard Error of the Mean|1.0||0.083|2-Sided|95.0|-0.2|3.7|||MMRM||UMEC 31.25 mcg vs Placebo, SBP, Week 4||
1593971|NCT03012061|2930807|Superiority||Mean Difference (Net)|0.1976|Standard Error of the Mean|0.0453|<|0.001|2-Sided|95.0|0.1086|0.2866|||ANCOVA||UMEC 62.5 mcg vs Placebo||
1593972|NCT03012061|2930807|Superiority||Mean Difference (Net)|0.1895|Standard Error of the Mean|0.0455|<|0.001|2-Sided|95.0|0.1|0.2789||Analysis of covariance (ANCOVA)|ANCOVA||UMEC 31.25 mcg vs Placebo||
1593973|NCT03012061|2930808|Superiority||Mean Difference (Net)|0.1841|Standard Error of the Mean|0.0424|<|0.001|2-Sided|95.0|0.1008|0.2675|||MMRM||UMEC 62.5 mcg versus placebo||
1593974|NCT03012061|2930808|Superiority||Mean Difference (Net)|0.1758|Standard Error of the Mean|0.0426|<|0.001|2-Sided|95.0|0.092|0.2595|||Mixed-model repeated measures (MMRM)||UMEC 31.25 mcg versus placebo||
1593975|NCT03010800|2930833|Superiority|||||||0.0469||||||One subject experienced incontinence with the Yoni.Fit in place (#8) (9.2 g Pad Wt. Without and 17.3 g Pad Wt. With). This was attributed to incorrect Yoni.Fit sizing. This subject was not included in the p-value calculation.|Wilcoxon (Mann-Whitney)|||"Null hypothesis is that the pad weights With Yoni.Fit and Without Yoni.Fit are equivalent.~A one-sided Wilcoxson paired T-test of the group means will be performed. If the p-value is significant, the null hypothesis will be rejected."|
1593976|NCT03010631|2930835|Other||Ratio of Geometric LS Means|0.413|||||2-Sided|90.0|0.339|0.502|||||||
1593977|NCT03010631|2930836|Other||Ratio of Geometric LS Means|0.888|||||2-Sided|90.0|0.675|1.168|||||||
1593978|NCT03010631|2930837|Superiority||Ratio of Geometric LS Means|2.045|||||2-Sided|90.0|1.615|2.589|||||||
1593979|NCT03010631|2930838|Superiority||Ratio of Geometric LS Means|1.441|||||2-Sided|90.0|1.166|1.782|||||||
1593980|NCT03010501|2930839|Superiority||||||<|0.0001||||||According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.|Mixed Models Analysis||||
1593981|NCT03010501|2930840|Superiority|||||||0.15||||||According to predefined comparisons, intake by weight in the 120% intervention was compared to the 100% intervention.|Mixed Models Analysis||||
1593982|NCT03010501|2930840|Superiority|||||||0.1||||||According to predefined comparisons, intake by weight in the 80% intervention was compared to the 100% intervention.|Mixed Models Analysis||||
1593983|NCT03010501|2930841|Superiority||||||<|0.0001||||||According to predefined comparisons, outcomes of the 80% and 120% Food Energy Density interventions were compared to the outcome of the baseline (100%) intervention.|Mixed Models Analysis||||
1593984|NCT03010254|2930842|Superiority||Percent difference|21.7|||||2-Sided|95.0|7.92|35.06|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).||
1593985|NCT03010254|2930843|Superiority||Difference in percentage|20.2|||||2-Sided|95.0|8.77|31.04|||||95% CI for the difference (DFT015 - SN60WF) is estimated using Miettinen-Nurminen method (1985).||
1593986|NCT03010254|2930844|Non-Inferiority|Non-inferiority margin was -0.15 log unit|Least Squares Mean Difference|-0.181|Standard Error of the Mean|0.0541|||1-Sided|97.5|-0.287||||||Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.|With glare|
1593987|NCT03010254|2930844|Non-Inferiority|Non-inferiority margin was -0.15 log unit|Least Squares Mean Difference|-0.179|Standard Error of the Mean|0.0551|||1-Sided|97.5|-0.287||||||Least squares mean difference (DFT015 - SN60WF). The 1-sided 97.5 Lower Limit Confidence Interval is presented.|Without glare|
1593988|NCT03010254|2930845|Other||Mean difference in depth of focus|0.52|||||2-Sided||||||||Mean difference in depth of focus (DFT015 - SN60WF)||
1593989|NCT03010254|2930846|Superiority||Least Squares Mean Difference|-0.09|Standard Error of the Mean|0.0216|<|0.001|2-Sided|95.0|-0.133|-0.048||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)||
1593990|NCT03010254|2930847|Non-Inferiority|Non-inferiority margin was 0.1 logMAR.|Least Squares Mean Difference|0.037|Standard Error of the Mean|0.0115|||1-Sided|97.5||0.059|||||Least squares mean difference (DFT015 - SN60WF).The 1-sided 97.5% Upper Confidence Limit is presented.||
1593991|NCT03010254|2930849|Superiority||Least Squares Mean Difference|-0.138|Standard Error of the Mean|0.021|<|0.001|2-Sided|95.0|-0.18|-0.097||2-sided p-value reported. A hypothesis test was based on a two sample t-test, with a type I error rate of 0.025, 1-sided.|t-test, 2 sided||Least squares mean difference (DFT015 - SN60WF)||
1593992|NCT03006341|2930902|Other||Adjusted R squared statistic|0.34|||||||||||||The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.|
1593993|NCT03006341|2930903|Other||C-Statistic|0.69|||||||||||||The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the “concordance” statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model.|
1593994|NCT03006341|2930904|Other||C-Statistic|0.88|||||||||||||The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|The concordance statistic is equal to the area under a ROC curve. The C-statistic (sometimes called the “concordance” statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model.|
1594069|NCT03002818|2931036|Superiority||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=36): Baseline vs. Day 84|
1593995|NCT03006341|2930910|Other||Adjusted R squared statistic|0.04|||||||||||||The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.|
1593996|NCT03006341|2930912|Other||Adjusted R squared statistic|0.02|||||||||||||The adjusted R² statistic, or coefficient of determination, is the proportion of the variance in the (EMR) outcome that is predictable from the independent (claims) variables, adjusted for the number of predictors in the model.|R-squared is a statistical measure of how close the data are to the fitted regression line. 0% indicates that the model explains none of the variability of the response data around its mean. 100% indicates that the model explains all the variability of the response data around its mean.|
1593997|NCT03006341|2930914|Other||C-Statistic|0.81|||||||||||||The C-statistic can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.|The concordance statistic is equal to the area under a receiver operating characteristic (ROC) curve. The C-statistic (sometimes called the “concordance” statistic or C-index) is a measure of goodness of fit for binary outcomes in a logistic regression model.|
1593998|NCT03005067|2930922|Other||Mean Difference (Net)|0.137||||0.516|2-Sided|95.0|-0.279|0.553||P-value was based on the Wald statistic Chi-Square test, from an ANCOVA model with treatment, center, and Day 1 dosing time stratification as factors and baseline NSS (Day 1 prior to the first dose) as a covariate.|ANCOVA||Difference of LS mean is 1146A Formulation Nasal Spray - Placebo Nasal Spray. 95% CI is for difference of LS means.||
1593999|NCT03004924|2930940|Superiority||Difference in response rate|-3.5||||0.5|2-Sided|95.0|-12.8|5.9|||Fisher Exact||||
1594000|NCT03004924|2930941|Superiority||Difference in response rate|7.7||||0.127|2-Sided|95.0|-1.6|16.9|||Fisher Exact||||
1594001|NCT03004911|2930943|Superiority|||||||0.459|||||||t-test, 2 sided||||
1594002|NCT03004911|2930944|Superiority|||||||1|||||||t-test, 2 sided||||
1594003|NCT03004911|2930945|Superiority|||||||0.747|||||||t-test, 2 sided||||
1594004|NCT03004911|2930946|Superiority|||||||0.89|||||||t-test, 2 sided||||
1594005|NCT03004911|2930947|Superiority|||||||0.74|||||||t-test, 2 sided||||
1594006|NCT03004469|2931002|Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.3||0.55|2-Sided|95.0|-0.8|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 24|
1594007|NCT03004469|2931002|Other||LS Mean Difference|0.0|Standard Error of the Mean|0.3||0.993|2-Sided|95.0|-0.6|0.6|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 12|
1594008|NCT03004469|2931002|Other||LS Mean Difference|0.1|Standard Error of the Mean|0.29||0.713|2-Sided|95.0|-0.5|0.7|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 8|
1594009|NCT03004469|2931002|Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.29||0.824|2-Sided|95.0|-0.6|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Overall Satisfaction Score, Week 4|
1594010|NCT03004469|2931002|Other||LS Mean Difference|-0.9|Standard Error of the Mean|0.65||0.156|2-Sided|95.0|-2.2|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 24|
1594011|NCT03004469|2931002|Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.66||0.642|2-Sided|95.0|-1.6|1.0|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 12|
1594012|NCT03004469|2931002|Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.67||0.562|2-Sided|95.0|-1.7|0.9|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 8|
1594013|NCT03004469|2931002|Other||LS Mean Difference|-1.4|Standard Error of the Mean|0.66||0.041|2-Sided|95.0|-2.7|-0.1|||Mixed linear model|||Statistical Analysis details presented here is for Intercourse Satisfaction Score, Week 4|
1594014|NCT03004469|2931002|Other||LS Mean Difference|0.0|Standard Error of the Mean|0.23||0.981|2-Sided|95.0|-0.4|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 24|
1594015|NCT03004469|2931002|Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.2||0.183|2-Sided|95.0|-0.7|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 12|
1594016|NCT03004469|2931002|Other||LS Mean Difference|0.0|Standard Error of the Mean|0.22||0.926|2-Sided|95.0|-0.5|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 8|
1594017|NCT03004469|2931002|Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.23||0.295|2-Sided|95.0|-0.7|0.2|||Mixed linear model|||Statistical Analysis details presented here is for Sexual Desire Score, Week 4|
1594018|NCT03004469|2931002|Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.34||0.593|2-Sided|95.0|-0.9|0.5|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 24|
1594019|NCT03004469|2931002|Other||LS Mean Difference|0.5|Standard Error of the Mean|0.078||0.078|2-Sided|95.0|-0.1|1.1|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 12|
1594020|NCT03004469|2931002|Other||LS Mean Difference|0.0|Standard Error of the Mean|0.36||0.918|2-Sided|95.0|-0.7|0.8|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 8|
1594021|NCT03004469|2931002|Other||LS Mean Difference|0.3|Standard Error of the Mean|0.28||0.272|2-Sided|95.0|-0.2|0.9|||Mixed linear model|||Statistical Analysis details presented here is for Orgasmic Function Score, Week 4|
1594022|NCT03004469|2931002|Other||LS Mean Difference|-0.8|Standard Error of the Mean|1.02||0.449|2-Sided|95.0|-2.8|1.2|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 24|
1594023|NCT03004469|2931002|Other||LS Mean Difference|-0.2|Standard Error of the Mean|1.0||0.842|2-Sided|95.0|-2.2|1.8|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 12|
1597182|NCT02915835|2935802|Superiority|||||||1|||||||Fisher Exact||||
1594024|NCT03004469|2931002|Other||LS Mean Difference|-0.7|Standard Error of the Mean|1.1||0.545|2-Sided|95.0|-2.8|1.5|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 8|
1594025|NCT03004469|2931002|Other||LS Mean Difference|-1.7|Standard Error of the Mean|1.03||0.103|2-Sided|95.0|-3.7|0.3|||Mixed linear model|||Statistical Analysis details presented here is for Erectile Function Score, Week 4|
1594026|NCT03004469|2931003|Other||LS Mean Difference|0.1|Standard Error of the Mean|0.12||0.262|2-Sided|95.0|-0.1|0.4|||Mixed linear model|||Statistical Analysis details presented here is for Week 24|
1594027|NCT03004469|2931003|Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.1||0.179|2-Sided|95.0|-0.3|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Week 12|
1594028|NCT03004469|2931004|Other||LS Mean Difference|0.4|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|0.2|0.7|||Mixed linear model|||Statistical Analysis details presented here is for Week 24|
1594029|NCT03004469|2931004|Other||LS Mean Difference|0.1|Standard Error of the Mean|0.14|<|0.708|2-Sided|95.0|-0.2|0.3|||Mixed linear model|||Statistical Analysis details presented here is for Week 12|
1594030|NCT03004469|2931005|Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.12||0.129|2-Sided|95.0|-0.4|0.1|||Mixed linear model|||Statistical Analysis details presented here is for Week 24|
1594031|NCT03004469|2931005|Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.11||0.569|2-Sided|95.0|-0.3|0.2|||Mixed linear model|||Statistical Analysis details presented here is for Week 12|
1594032|NCT03004469|2931006|Other||LS Mean Difference|0.7237|Standard Error of the Mean|0.47799||0.131|2-Sided|95.0|-0.2184|1.6657|||Mixed linear model|||Statistical Analysis details presented here is for Week 24|
1594033|NCT03004469|2931006|Other||LS Mean Difference|-0.4024|Standard Error of the Mean|0.4057||0.322|2-Sided|95.0|-1.202|0.3971|||Mixed linear model|||Statistical Analysis details presented here is for Week 12|
1594034|NCT03004469|2931007|Other||LS Mean Difference|12.8|Standard Error of the Mean|3.19|<|0.001|2-Sided|95.0|6.5|19.1|||Mixed linear model||||
1594035|NCT03004469|2931008|Other||LS Mean Difference|13.6|Standard Error of the Mean|3.94|<|0.001|2-Sided|95.0|5.8|21.3|||Mixed linear model||||
1594036|NCT03003520|2931011|Superiority||AUC-ROC|0.6||||0.399|2-Sided|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their IFNG-Score.|
1594037|NCT03003520|2931011|Superiority|||||||0.662||||||Significance defined as 0.05.|Fisher Exact||||
1594038|NCT03003520|2931012|Superiority||AUC-ROC|0.583||||0.557|2-Sided|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their PDL1 % of tumor cells.|
1594039|NCT03003520|2931012|Superiority||||||>|0.99||||||Significance defined as 0.05.|Fisher Exact||||
1594040|NCT03003520|2931013|Superiority||AUC-ROC|0.583||||0.523|2-Sided|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their PDL1 % of total cells.|
1594041|NCT03003520|2931013|Superiority|||||||0.0403||||||Significance defined as 0.05.|Fisher Exact||||
1594042|NCT03003520|2931014|Superiority||AUC-ROC|0.477||||0.872|2-Sided|||||Significance defined as 0.05.|Wilcoxon (Mann-Whitney)|||The Area Under the Receiver Operator Characteristic Curve (AUC-ROC) is the estimated parameter. Responders were compared to non-responders by ranking them according to their CD8 density.|
1594043|NCT03003520|2931014|Superiority||||||>|0.99||||||Significance defined as 0.05.|Fisher Exact||||
1594044|NCT03003000|2931023|Superiority|||||||0.3534||||||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Log Rank|p-value based on a stratified log-rank test|||
1594045|NCT03003000|2931023|Superiority|||||||0.9384||||||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Log Rank|p-value based on a stratified log-rank test|||
1594046|NCT03003000|2931024|Superiority||Odds Ratio (OR)|0.68||||0.0864|2-Sided|95.0|0.437|1.057||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%.|An odds ratio >1 indicates better efficacy for ibuprofen and caffeine than for the comparator||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.
1594047|NCT03003000|2931024|Superiority||Odds Ratio (OR)|1.354||||0.3301|2-Sided|95.0|0.736|2.494||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥50%.|An odds ratio >1 indicates better efficacy for ibuprofen and caffeine than for the comparator||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.
1594048|NCT03003000|2931024|Superiority||Odds Ratio (OR)|0.834||||0.3129|2-Sided|95.0|0.586|1.187||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥30%.|An odds ratio >1 indicates better efficacy for ibuprofen and caffeine than for the comparator.||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.
1594049|NCT03003000|2931024|Superiority||Odds Ratio (OR)|1.028||||0.9022|2-Sided|95.0|0.663|1.592||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|likelihood-ratio test|The likelihood-ratio test was used to test treatment differences for patients with a decrease of ≥30%.|An odds ratio >1 indicates better efficacy for ibuprofen and caffeine than for the comparator.||Results are based on the Logistic regression. Logistic regression model was adjusted for the categorical covariates country and worst procedure site.
1594070|NCT03002818|2931036|Superiority||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=22): Baseline vs. Day 28|
1594071|NCT03002818|2931036|Superiority||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=35): Baseline vs. Day 28|
1594050|NCT03003000|2931025|Superiority||Odds Ratio (OR)|1.008||||0.9603|2-Sided|95.0|0.732|1.389||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Regression, Logistic|An ordinal logistic regression model adjusting for country and worst procedure site.|An odds ratio >1 indicates better efficacy for ibuprofen and caffeine than for the comparator||
1594051|NCT03003000|2931025|Superiority||Odds Ratio (OR)|1.777||||0.0045|2-Sided|95.0|1.195|2.642||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Regression, Logistic|An ordinal logistic regression model adjusting for country and worst procedure site.|An odds ratio >1 indicates better efficacy for ibuprofen and caffeine than for the comparator||
1594052|NCT03003000|2931026|Superiority||Mean Difference (Final Values)|0.156||||0.7911|2-Sided|95.0|-1.002|1.314||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeat Measurement||Adjusted mean change ibuprofen and caffeine - Adjusted mean change ibuprofen. A negative result favors ibuprofen and caffeine.|MMRM includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time as well as the continuous fixed covariates of baseline pressure algometry and baseline-by-time interaction, using unstructured covariance matrix.|
1594053|NCT03003000|2931026|Superiority||Mean Difference (Final Values)|0.559||||0.4398|2-Sided|95.0|-0.861|1.979||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect model for repeated measures||Adjusted mean change ibuprofen and caffeine - Adjusted mean change placebo. A negative result favors ibuprofen and caffeine.|Mixed effect model for repeated measures (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time as well as the continuous fixed covariates of baseline pressure algometry and baseline-by-time interaction, using unstructured covariance matrix.|
1594054|NCT03003000|2931027|Superiority||Mean Difference (Final Values)|0.058||||0.6387|2-Sided|95.0|-0.185|0.302||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine||
1594055|NCT03003000|2931027|Superiority||Mean Difference (Final Values)|-0.399||||0.0091|2-Sided|95.0|-0.698|-0.1||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean placebo. A negative result favors ibuprofen and caffeine||
1594056|NCT03003000|2931028|Superiority||Mean Difference (Final Values)|0.051||||0.6658|2-Sided|95.0|-0.18|0.282||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|The ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean ibuprofen. A negative result favors ibuprofen and caffeine.||
1594057|NCT03003000|2931028|Superiority||Mean Difference (Final Values)|-0.288||||0.0474|2-Sided|95.0|-0.572|-0.003||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|ANCOVA|ANCOVA included treatment, country, and worst procedure site as fixed effects and baseline POMwp as a continuous covariate.|Adjusted mean ibuprofen and caffeine - Adjusted mean placebo. A negative result favors ibuprofen and caffeine||
1594058|NCT03003000|2931029|Superiority||Mean Difference (Final Values)|-0.129||||0.3358|2-Sided|95.0|-0.392|0.134||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeat Measurement||Adjusted mean change from baseline ibuprofen and caffeine - Adjusted mean change from baseline ibuprofen. A positive result favors the treatment with ibuprofen and caffeine|Superiority of ibuprofen and caffeine versus ibuprofen as well as ibuprofen and caffeine versus placebo had to be shown to reject the overall null hypothesis that there is no difference in change in POMWP between baseline and Day 2 (morning, 2 h after drug intake) between patients treated with ibuprofen/caffeine and patients treated with ibuprofen.|Mixed effect model for repeated measures analysis (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time, treatment-by-stratum-by-time, treatment-by-stratum and stratum-by-time interaction, as well as the continuous fixed covariates of baseline POMwp and baseline-by-time interaction, using unstructured covariance matrix
1594059|NCT03003000|2931029|Superiority||Mean Difference (Final Values)|0.156||||0.3446|2-Sided|95.0|-0.168|0.48||No adjustment for multiplicity issues was made for this comparison. The level of significance was 0.05.|Mixed effect Model Repeated Measurement||Adjusted mean change from baseline ibuprofen and caffeine - Adjusted mean change from baseline placebo. A positive result favors the treatment with ibuprofen and caffeine|Superiority of ibuprofen and caffeine versus ibuprofen as well as ibuprofen and caffeine versus placebo had to be shown to reject the overall null hypothesis that there is no difference in change in POMWP between baseline and Day 2 (morning, 2 h after drug intake) between patients treated with ibuprofen/caffeine and patients treated with placebo.|Mixed effect model for repeated measures analysis (MMRM) includes fixed, categorical effects of treatment, country, worst procedure site, time and interaction terms for treatment-by-time, treatment-by-stratum-by-time, treatment-by-stratum and stratum-by-time interaction, as well as the continuous fixed covariates of baseline POMwp and baseline-by-time interaction, using unstructured covariance matrix.
1594060|NCT03002818|2931035|Superiority|||||||0.775|||||||Paired Wilcoxon Test|||sdITT (n=23): Baseline vs. Day 84|
1594061|NCT03002818|2931035|Superiority|||||||0.881|||||||Paired Wilcoxon Test|||sdITT (n=36): Baseline vs. Day 84|
1594062|NCT03002818|2931035|Superiority|||||||0.278|||||||Paired Wilcoxon Test|||mITT (n=22): Baseline vs. Day 28|
1594063|NCT03002818|2931035|Superiority|||||||0.014|||||||Paired Wilcoxon Test|||sdITT (n=35): Baseline vs. Day 28|
1594064|NCT03002818|2931035|Superiority|||||||0.304|||||||Paired Wilcoxon Test|||mITT (n=24): Baseline vs. Day 168|
1594065|NCT03002818|2931035|Superiority|||||||0.381|||||||Paired Wilcoxon Test|||sdITT (n=37): Baseline vs. Day 168|
1594066|NCT03002818|2931035|Superiority||mean change|0.74|||||2-Sided|95.0|-0.608|2.088||||||mITT: mean change Baseline minus Day 168|
1594067|NCT03002818|2931035|Superiority||mean change|0.61|||||2-Sided|95.0|-0.651|1.871||||||sdITT: mean change Baseline minus Day 168|
1594068|NCT03002818|2931036|Superiority||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=23): Baseline vs. Day 84|
1594072|NCT03002818|2931036|Superiority||||||<|0.001|||||||Paired Wilcoxon Test|||mITT (n=24): Baseline vs. Day 168|
1594073|NCT03002818|2931036|Superiority||||||<|0.001|||||||Paired Wilcoxon Test|||sdITT (n=37): Baseline vs. Day 168|
1594074|NCT03002818|2931036|Superiority||mean change|2.82|||<||2-Sided|95.0|2.212|3.428||||||mITT: mean change Baseline minus Day 168|
1594075|NCT03002818|2931036|Superiority||mean change|2.6|||<||2-Sided|95.0|2.063|3.137||||||sdITT: mean change Baseline minus Day 168|
1594076|NCT03002818|2931037|Superiority|||||||0.75|||||||paired t-test|||mITT (n=24): Baseline vs. Day 84|
1594077|NCT03002818|2931037|Superiority|||||||0.855|||||||paired t-test|||sdITT (n=32): Baseline vs. Day 84|
1594078|NCT03002818|2931037|Superiority|||||||0.63|||||||paired t-test|||mITT (n=24): Baseline vs. Day 28|
1594079|NCT03002818|2931037|Superiority|||||||0.461|||||||paired t-test|||sdITT (n=34): Baseline vs. Day 28|
1594080|NCT03002818|2931038|Superiority|||||||0.152|||||||paired t-test|||mITT (n=24): Baseline vs. Day 168|
1594081|NCT03002818|2931038|Superiority|||||||0.091|||||||paired t-test|||sdITT (n=26): Baseline vs. Day 168|
1594082|NCT03002818|2931038|Superiority||mean change|-98373.0||||0.152|2-Sided|95.0|-235667.0|38921.0|||one-sample t-test|||mITT (n=24): Change at Day 168 minus Baseline|
1594083|NCT03002818|2931038|Superiority||mean change|-108266.0||||0.091|2-Sided|95.0|-235037.0|18504.0|||one-sample t-test|||sdITT (n=26): Change at Day 168 minus Baseline|
1594084|NCT03002454|2931051|Equivalence|"Control: 99mTc MDP Injection:fission Investigation: 99mTc MDP Injection:neutron-bombardment~Anticipated sample size of 50 participants with sample size parameters of:~Alpha 0.05 Power 80% Kappa of significance 0.7 - 0.8 Prevalence of abnormal bone scans 30%~Actual study population of 4 participants with 4 out of 4 demonstrating gross abnormal biodistribution therefore the study was terminated and no statistical analysis was conducted."|||||||||||||||||No statistical analysis - insufficient study population
1594085|NCT03001557|2931069|Superiority||LSM Difference|0.057||||0.0364|2-Sided|95.0|0.004|0.11||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction|MMRM||||
1594086|NCT03001557|2931069|Superiority||LSM Difference|0.003||||0.9144|2-Sided|95.0|-0.051|0.056||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594087|NCT03001557|2931069|Superiority||LSM Difference|0.06||||0.0322|2-Sided|95.0|0.005|0.115||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594088|NCT03001557|2931069|Superiority||LSM Difference|0.02||||0.4638|2-Sided|95.0|-0.034|0.074||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594089|NCT03001557|2931073|Superiority||LSM Difference|-130.603||||0.8686|2-Sided|95.0|-1706.478|1445.272||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594090|NCT03001557|2931073|Superiority||LSM Difference|-447.245||||0.5655|2-Sided|95.0|-1998.44|1103.95||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594091|NCT03001557|2931073|Superiority||LSM Difference|651.922||||0.4218|2-Sided|95.0|-962.835|2266.678||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594092|NCT03001557|2931073|Superiority||LSM Difference|-839.088||||0.2984|2-Sided|95.0|-2440.854|762.678||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594093|NCT03001557|2931077|Superiority||LSM Difference|-577.82||||0.4672|2-Sided|95.0|-2160.337|1004.697||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594094|NCT03001557|2931077|Superiority||LSM Difference|-620.581||||0.4255|2-Sided|95.0|-2170.342|929.179||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594095|NCT03001557|2931077|Superiority||LSM Difference|227.464||||0.7781|2-Sided|95.0|-1382.85|1837.777||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594096|NCT03001557|2931077|Superiority||LSM Difference|-1276.18||||0.1162|2-Sided|95.0|-2878.587|326.226||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594097|NCT03001557|2931081|Superiority||LSM Difference|-367.845||||0.0398|2-Sided|95.0|-717.87|-17.82||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594098|NCT03001557|2931081|Superiority||LSM Difference|-141.026||||0.4209|2-Sided|95.0|-489.805|207.752||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594099|NCT03001557|2931081|Superiority||LSM Difference|-402.994||||0.0243|2-Sided|95.0|-751.67|-54.319||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594100|NCT03001557|2931081|Superiority||LSM Difference|-389.873||||0.0294|2-Sided|95.0|-739.177|-40.569||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594101|NCT03001557|2931085|Superiority||LSM Difference|0.005||||0.8618|2-Sided|95.0|-0.055|0.066||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594102|NCT03001557|2931085|Superiority||LSM Difference|-0.052||||0.0938|2-Sided|95.0|-0.113|0.009||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594103|NCT03001557|2931085|Superiority||LSM Difference|0.033||||0.2861|2-Sided|95.0|-0.028|0.095||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594104|NCT03001557|2931085|Superiority||LSM Difference|-0.032||||0.2991|2-Sided|95.0|-0.094|0.029||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594105|NCT03001557|2931089|Superiority||LSM Difference|0.025||||0.7248|2-Sided|95.0|-0.116|0.166||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594106|NCT03001557|2931089|Superiority||LSM Difference|0.057||||0.4251|2-Sided|95.0|-0.085|0.199||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594107|NCT03001557|2931089|Superiority||LSM Difference|-0.012||||0.8661|2-Sided|95.0|-0.155|0.131||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594108|NCT03001557|2931089|Superiority||LSM Difference|0.086||||0.2421|2-Sided|95.0|-0.06|0.232||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594109|NCT03001557|2931093|Superiority||LSM Difference|-1.557||||0.2274|2-Sided|95.0|-4.113|1.0||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594110|NCT03001557|2931093|Superiority||LSM Difference|-0.293||||0.8117|2-Sided|95.0|-2.745|2.16||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594111|NCT03001557|2931093|Superiority||LSM Difference|-0.238||||0.8541|2-Sided|95.0|-2.817|2.342||Based on a MMRM analysis adjusted for baseline value, country, Visit and treatment by Visit interaction.|MMRM||||
1594112|NCT03001557|2931093|Superiority||LSM Difference|0.063||||0.9599|2-Sided|95.0|-2.452|2.579||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594113|NCT03001557|2931097|Superiority||LSM Difference|3.017||||0.4148|2-Sided|95.0|-4.344|10.379||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594114|NCT03001557|2931097|Superiority||LSM Difference|6.776||||0.0664|2-Sided|95.0|-0.474|14.025||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594115|NCT03001557|2931097|Superiority||LSM Difference|-3.872||||0.2982|2-Sided|95.0|-11.263|3.518||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594116|NCT03001557|2931097|Superiority||LSM Difference|4.845||||0.1991|2-Sided|95.0|-2.624|12.313||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594117|NCT03001557|2931101|Superiority||LSM Difference|-2.593||||0.3036|2-Sided|95.0|-7.599|2.413||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594118|NCT03001557|2931101|Superiority||LSM Difference|-4.994||||0.0482|2-Sided|95.0|-9.946|-0.041||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594119|NCT03001557|2931101|Superiority||LSM Difference|1.458||||0.563|2-Sided|95.0|-3.564|6.479||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594120|NCT03001557|2931101|Superiority||LSM Difference|-3.437||||0.1777|2-Sided|95.0|-8.481|1.608||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594121|NCT03001557|2931105|Superiority||LSM Difference|4.32||||0.0581|2-Sided|95.0|-0.153|8.793||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594122|NCT03001557|2931105|Superiority||LSM Difference|1.337||||0.5487|2-Sided|95.0|-3.104|5.778||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594123|NCT03001557|2931105|Superiority||LSM Difference|3.386||||0.1381|2-Sided|95.0|-1.125|7.897||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594124|NCT03001557|2931105|Superiority||LSM Difference|1.932||||0.3966|2-Sided|95.0|-2.601|6.465||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594125|NCT03001557|2931109|Superiority||LSM Difference|-3.14||||0.3747|2-Sided|95.0|-10.178|3.897||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594126|NCT03001557|2931109|Superiority||LSM Difference|0.68||||0.8449|2-Sided|95.0|-6.262|7.623||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594127|NCT03001557|2931109|Superiority||LSM Difference|-6.105||||0.0961|2-Sided|95.0|-13.332|1.122||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594128|NCT03001557|2931109|Superiority||LSM Difference|-5.098||||0.1582|2-Sided|95.0|-12.24|2.045||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594129|NCT03001557|2931113|Superiority||LSM Difference|0.713||||0.7135|2-Sided|95.0|-3.16|4.585||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594130|NCT03001557|2931113|Superiority||LSM Difference|-0.96||||0.616|2-Sided|95.0|-4.777|2.857||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594131|NCT03001557|2931113|Superiority||LSM Difference|2.802||||0.1576|2-Sided|95.0|-1.119|6.723||Based on a MMRM analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594132|NCT03001557|2931113|Superiority||Least square mean (LSM) difference|3.177||||0.1099|2-Sided|95.0|-0.741|7.096||Based on a mixed model for repeated measure (MMRM) analysis adjusted for baseline value, country, visit and treatment by visit interaction.|MMRM||||
1594133|NCT03001076|2931138|Superiority||Difference in LS mean|-6.42|Standard Error of the Mean|1.712|<|0.001|2-Sided|95.0|-9.798|-3.049|||ANCOVA|||Change from Baseline to Week 8|
1594134|NCT03001076|2931138|Superiority||Difference in LS mean|-8.59|Standard Error of the Mean|1.619|<|0.001|2-Sided|95.0|-11.778|-5.394|||ANCOVA|||Change from Baseline to Week 4|
1594135|NCT03001076|2931139|Superiority||Difference in LS mean|-0.08|Standard Error of the Mean|5.131|=|0|2-Sided|95.0|-10.215|10.055|||ANCOVA|||Change from Baseline to Week 8|
1594136|NCT03001076|2931139|Superiority||Difference in LS mean|-0.8|Standard Error of the Mean|4.99|=|0|2-Sided|95.0|-10.663|9.059|||ANCOVA|||Change from Baseline to Week 4|
1594137|NCT03001076|2931140|Superiority||Difference in LS mean|-18.46|Standard Error of the Mean|1.651|<|0.001|2-Sided|95.0|-21.71|-15.206|||ANCOVA|||Change from Baseline to Week 8|
1594138|NCT03001076|2931140|Superiority||Difference in LS mean|-20.41|Standard Error of the Mean|1.513|<|0.001|2-Sided|95.0|-23.39|-17.43|||ANCOVA|||Change from Baseline to Week 4|
1594139|NCT03001076|2931141|Superiority||Difference in LS mean|-23.75|Standard Error of the Mean|2.268|<|0.001|2-Sided|95.0|-28.219|-19.276|||ANCOVA|||Change from Baseline to Week 8|
1594140|NCT03001076|2931141|Superiority||Difference in LS mean|-25.26|Standard Error of the Mean|2.004|<|0.001|2-Sided|95.0|-29.204|-21.308|||ANCOVA|||Change from Baseline to Week 4|
1594141|NCT03001076|2931142|Superiority||Difference in LS mean|-29.12|Standard Error of the Mean|2.513|<|0.001|2-Sided|95.0|-34.074|-24.168|||ANCOVA|||Change from Baseline to Week 8|
1610771|NCT02544607|2958781|Other|||||||0.003|||||||t-test, 2 sided||||
1594142|NCT03001076|2931142|Superiority||Difference in LS mean|-31.09|Standard Error of the Mean|2.238|<|0.001|2-Sided|95.0|-35.498|-26.682|||ANCOVA|||Change from Baseline to Week 4|
1594143|NCT03001076|2931144|Superiority||Difference in LS mean|-5.89|Standard Error of the Mean|1.845|=|0|2-Sided|95.0|-9.528|-2.25|||ANCOVA||||
1594144|NCT03001076|2931145|Superiority||Difference in LS mean|-4.53|Standard Error of the Mean|5.24|=|0|2-Sided|95.0|-14.877|5.812|||ANCOVA||||
1594145|NCT03001076|2931146|Superiority||Location shift|-31.045|||<|0.001|2-Sided|95.0|-44.761|-17.401|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.||
1594146|NCT03001076|2931147|Superiority||Difference in LS mean|-19.32|Standard Error of the Mean|2.341|<|0.001|2-Sided|95.0|-23.908|-14.732|||ANCOVA||||
1594147|NCT03001076|2931148|Superiority||Difference in LS mean|-17.99|Standard Error of the Mean|2.018|<|0.001|2-Sided|95.0|-21.94|-14.03|||ANCOVA||||
1594148|NCT03001076|2931149|Superiority||Difference in LS mean|-23.56|Standard Error of the Mean|2.777|<|0.001|2-Sided|95.0|-29.005|-18.121|||ANCOVA||||
1594149|NCT03001076|2931150|Superiority||Difference in LS mean|-28.45|Standard Error of the Mean|3.022|<|0.001|2-Sided|95.0|-34.376|-22.531|||ANCOVA||||
1594150|NCT03000686|2931179|Other||Median Difference (Net)|-0.873|Standard Deviation|0.762|||2-Sided|95.0|-2.38|0.669|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.||
1594151|NCT03000686|2931179|Other||Median Difference (Net)|-1.029|Standard Deviation|2.8146|||2-Sided|95.0|-6.673|4.578|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 2 minutes post-exercise start is presented.||
1594152|NCT03000686|2931179|Other||Median Difference (Net)|3.76|Standard Deviation|1.8799|||2-Sided|95.0|-0.001|7.495|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.||
1594153|NCT03000686|2931179|Other||Median Difference (Net)|0.203|Standard Deviation|0.8872|||2-Sided|95.0|-1.578|1.968|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.||
1594154|NCT03000686|2931180|Other||Median Difference (Net)|-0.367|Standard Deviation|0.5649|||2-Sided|95.0|-1.498|0.753|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 30 minutes post-chamber exit is presented.||
1594155|NCT03000686|2931180|Other||Median Difference (Net)|-0.169|Standard Deviation|2.2351|||2-Sided|95.0|-4.624|4.258|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation immediately post-exercise is presented.||
1594156|NCT03000686|2931180|Other||Median Difference (Net)|-1.172|Standard Deviation|2.072|||2-Sided|95.0|-5.271|2.942|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 60 minutes post-chamber entry is presented.||
1594157|NCT03000686|2931180|Other||Median Difference (Net)|-0.148|Standard Deviation|0.5622|||2-Sided|95.0|-1.264|0.973|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval for oxygen saturation at 15 minutes post-infusion is presented.||
1594158|NCT03000686|2931187|Other||Median Difference (Net)|-0.291|Standard Deviation|2.3277|||2-Sided|95.0|-4.96|4.386|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit||
1594159|NCT03000686|2931187|Other||Median Difference (Net)|-0.018|Standard Deviation|4.145|||2-Sided|95.0|-8.475|8.086|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 2 minutes post-exercise start||
1594160|NCT03000686|2931187|Other||Median Difference (Net)|-2.796|Standard Deviation|3.4297|||2-Sided|95.0|-9.729|4.027|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.||
1594161|NCT03000686|2931187|Other||Median Difference (Net)|-0.662|Standard Deviation|2.1933|||2-Sided|95.0|-5.037|3.815|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion||
1594162|NCT03000686|2931188|Other||Median Difference (Net)|-0.824|Standard Deviation|1.6695|||2-Sided|95.0|-4.142|2.506|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 30 minutes post-chamber exit||
1594163|NCT03000686|2931188|Other||Median Difference (Net)|-1.668|Standard Deviation|4.4927|||2-Sided|95.0|-10.576|7.231|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for immediately post-exercise||
1594164|NCT03000686|2931188|Other||Median Difference (Net)|-4.021|Standard Deviation|2.5923|||2-Sided|95.0|-9.168|1.146|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 60 minutes post-chamber entry.||
1594165|NCT03000686|2931188|Other||Median Difference (Net)|0.021|Standard Deviation|1.1339|||2-Sided|95.0|-2.249|2.295|||||Posterior median difference (GSK2586881 0.8 mg/kg - Placebo) and 95% credible interval is presented for 15 minutes post-infusion||
1594166|NCT03000075|2931229|Other|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs > 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|31.3||||0.269|2-Sided|95.0|-24.2|86.7||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1594167|NCT03000075|2931229|Other||Adjusted percentage difference|39.2||||0.131|2-Sided|95.0|-11.6|90.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs > 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|
1594207|NCT02997735|2931372|Superiority||Odds Ratio (OR)|0.48||||0.15|2-Sided|95.0|0.13|1.72|||Chi-squared||1-5 years Row (<1 Ref)||
1610772|NCT02544607|2958782|Other|||||||0.048|||||||t-test, 2 sided||||
1594168|NCT03000075|2931231|Other||Adjusted percentage difference|32.5|||<|0.001|2-Sided|95.0|20.0|45.0||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs > 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|
1594169|NCT03000075|2931231|Other||Adjusted percentage difference|22.6|||<|0.001|2-Sided|95.0|11.8|33.4||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs > 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|
1594170|NCT03000075|2931233|Other||Adjusted percentage difference|86.0|||<|0.001|2-Sided|95.0|76.8|95.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs > 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|
1594171|NCT03000075|2931233|Other||Adjusted percentage difference|80.3|||<|0.001|2-Sided|95.0|70.1|90.4||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs > 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|
1594172|NCT03000075|2931235|Other||Adjusted percentage difference|82.4|||<|0.001|2-Sided|95.0|72.2|92.6||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs > 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|
1594173|NCT03000075|2931235|Other||Adjusted percentage difference|75.0|||<|0.001|2-Sided|95.0|63.8|86.2||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs > 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|
1594174|NCT03000075|2931237|Other|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs > 90 kg) and concomitant PsA at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|72.4|||<|0.001|2-Sided|95.0|60.6|84.1||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1594175|NCT03000075|2931237|Other|Cochran-Mantel-Haenszel test adjusted for strata: weight (≤ 90 kg vs > 90 kg) and concomitant psoriatic arthritis (PsA) at Baseline (YES: DIAGNOSED or SUSPECTED vs NO). If there was a stratum containing zero count, 0.1 was added to each cell.|Adjusted percentage difference|73.6|||<|0.001|2-Sided|95.0|62.2|85.0||P-value was calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% confidence interval (CI) for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1594176|NCT02999178|2931253|Other|No formal hypotheses were tested.|Adjusted mean difference|-7.28|Standard Error of the Mean|2.33|||2-Sided|95.0|-11.86|-2.71|||||Adjusted mean difference was calculated as Nintedanib – Placebo.||
1594177|NCT02999178|2931254|Other|No formal hypotheses were tested.|Adjusted mean difference|-6.09|Standard Error of the Mean|1.81|||2-Sided|95.0|-9.65|-2.53|||||Adjusted mean difference was calculated as Nintedanib – Placebo.||
1594178|NCT02999178|2931255|Other|No formal hypotheses were tested.|Adjusted mean difference|-4.18|Standard Error of the Mean|1.68|||2-Sided|95.0|-7.48|-0.88|||||Adjusted mean difference was calculated as Nintedanib – Placebo.||
1594179|NCT02999178|2931256|Other|No formal hypotheses were tested.|Adjusted mean difference|-3.53|Standard Error of the Mean|1.33|||2-Sided|95.0|-6.14|-0.92|||||Adjusted mean difference was calculated as Nintedanib – Placebo.||
1594180|NCT02999178|2931257|Other|No formal hypotheses were tested.|Adjusted Odds Ratio|0.46|||||2-Sided|95.0|0.31|0.69|||||Ratio calculated as Nintedanib divided by Placebo.||
1594181|NCT02999178|2931258|Other|No formal hypotheses were tested.|Adjusted Odds Ratio|0.5|||||2-Sided|95.0|0.36|0.68|||||Ratio calculated as Nintedanib divided by Placebo.||
1594182|NCT02999178|2931259|Other|No formal hypotheses were tested.|Adjusted Odds Ratio|0.63|||||2-Sided|95.0|0.43|0.94|||||Ratio calculated as Nintedanib divided by Placebo.||
1594183|NCT02999178|2931260|Other|No formal hypotheses were tested.|Adjusted Odds Ratio|0.7|||||2-Sided|95.0|0.52|0.96|||||Ratio calculated as Nintedanib divided by Placebo.||
1597183|NCT02915835|2935803|Superiority|||||||1|||||||Fisher Exact||||
1594184|NCT02999178|2931261|Other|No formal hypotheses were tested.|Hazard Ratio (HR)|0.64||||0.0081|2-Sided|95.0|0.45|0.89|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.||
1594185|NCT02999178|2931262|Other|No formal hypotheses were tested.|Hazard Ratio (HR)|0.65||||0.0017|2-Sided|95.0|0.49|0.85|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.||
1594186|NCT02999178|2931265|Other|No formal hypotheses were tested.|Hazard Ratio (HR)|0.68||||0.3291|2-Sided|95.0|0.32|1.47|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.||
1594187|NCT02999178|2931266|Other|No formal hypotheses were tested.|Hazard Ratio (HR)|0.94||||0.8544|2-Sided|95.0|0.47|1.86|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.||
1594188|NCT02999178|2931267|Other|No formal hypotheses were tested.|Hazard Ratio (HR)|0.67||||0.1985|2-Sided|95.0|0.36|1.24|||Log Rank||A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.||
1594189|NCT02999178|2931268|Other|No formal hypotheses were tested.|Hazard Ratio (HR)|0.8||||0.3948|2-Sided|95.0|0.48|1.34|||Log Rank|Stratified by HRCT fibrotic pattern.|A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.||
1594190|NCT02999178|2931269|Other|No formal hypotheses were tested.|Adjusted mean difference|1.53|Standard Error of the Mean|1.12||0.1747|2-Sided|95.0|-0.68|3.74|||Mixed Model Repeated Measures (MMRM)|Fixed effects: baseline K-BILD Total score, visit, treatment−by−visit and baseline−by−visit interactions, random effect: participant.|Adjusted mean difference was calculated as Nintedanib – Placebo.||
1594191|NCT02999178|2931270|Other|No formal hypotheses were tested.|Adjusted mean difference|1.34|Standard Error of the Mean|0.84||0.1115|2-Sided|95.0|-0.31|2.98|||Mixed Model Repeated Measures (MMRM)|Fixed effects: baseline K-BILD Total score, visit, treatment−by−visit and baseline−by−visit interactions, random effect: participant.|Adjusted mean difference was calculated as Nintedanib – Placebo.||
1594192|NCT02999178|2931271|Superiority||Adjusted mean difference|128.2|Standard Error of the Mean|29.17|<|0.0001|2-Sided|95.0|70.81|185.59||Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|Fixed effects: Treatment, baseline FVC (mL), treatment-by-time, baseline-by-time interactions. Random effects: time, intercept.|Difference of adjusted annual rates of decline was calculated as Nintedanib – Placebo.|The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).|
1594193|NCT02999178|2931272|Superiority||Adjusted mean difference|106.96|Standard Error of the Mean|21.15|<|0.0001|2-Sided|95.0|65.42|148.5||Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|"Fixed effects: Treatment, HRCT fibrotic pattern, baseline FVC (mL), treatment-by-time, baseline-by-time interactions.~Random effects: time, intercept."|Difference of adjusted annual rates of decline was calculated as Nintedanib – Placebo.|The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).|
1594194|NCT02998671|2931322|Superiority|Comparison at end of Period 1 (P1): CJM112 versus Placebo.|Ratio of geometric means|1.1|||||2-Sided|90.0|0.66|1.8|||||"Ratio of Geometric Means (CJM112 / Placebo) calculated. A value > 1 indicates a higher number of lesion counts in the CJM112 group.~Bayesian analysis. The “credible interval” was calculated and presented under confidence interval."||
1594195|NCT02998671|2931322|Superiority|Comparison at end of Period 1 (P1): CJM112 versus Placebo.|Ratio of geometric means|1.18|||||2-Sided|90.0|0.79|1.81|||||"Ratio of Geometric Means (CJM112 / Placebo) calculated. A value > 1 indicates a higher number of lesion counts in the CJM112 group.~Bayesian analysis. The “credible interval” was calculated and presented under confidence interval."||
1594196|NCT02997904|2931366|Superiority||Least Squares Mean Difference|0.7899|Standard Error of the Mean|0.04565|<|0.0001|2-Sided|95.0|0.6993|0.8805|||GLIMMX||||
1594197|NCT02997904|2931366|Superiority||Least Squares Mean Difference|1.2084|Standard Error of the Mean|0.0467|<|0.0001|2-Sided|95.0|1.1157|1.3011||The P-Values were <0.0001 in both comparison groups; total number lice removed and total number of eggs removed|GLIMMX|||Comparison of total number of lice removed and total number of eggs removed were analyzed separately|
1594198|NCT02997904|2931367|Superiority||Least Squares Mean Difference|1.0058|Standard Error of the Mean|0.2131|<|0.0001|2-Sided|95.0|0.5829|1.4288|||ANOVA|||Ho: Total Number of lice and eggs removed with Resultz® ≤ Total number of lice and eggs removed with sham control Ha: Total Number of lice and eggs removed with Resultz® > Total Number of lice and eggs removed with sham control|
1594199|NCT02997735|2931368|Superiority||Odds Ratio (OR)|0.67|||||2-Sided|95.0|0.15|2.21|||||||6 or more months Row (30 days Ref)
1594200|NCT02997735|2931368|Superiority||Odds Ratio (OR)|0.47||||0.35|2-Sided|95.0|0.15|1.27|||Chi-squared||Less than 6 months Row (30 days Ref)||
1594201|NCT02997735|2931369|Superiority||Odds Ratio (OR)|2.07||||0.086|2-Sided|95.0|0.9|6.5|||Chi-squared||10 or more cigarettes Row (<10 cigarettes Ref)||
1594202|NCT02997735|2931370|Superiority||Odds Ratio (OR)|1.1||||0.85|2-Sided|95.0|0.4|2.8|||Chi-squared||Asthma Row (No asthma Ref)||
1594203|NCT02997735|2931371|Superiority||Odds Ratio (OR)|5.1|||||2-Sided|95.0|1.46|17.32|||||50 or older Row (18-34 Ref)||
1594204|NCT02997735|2931371|Superiority||Odds Ratio (OR)|2.38||||0.028|2-Sided|95.0|0.92|6.5|||Chi-squared||35-49 years Row (18-34 Ref)||
1594205|NCT02997735|2931372|Superiority||Odds Ratio (OR)|1.82|||||2-Sided|95.0|0.49|6.94|||||13 or Older Row (<1 Ref)||
1594206|NCT02997735|2931372|Superiority||Odds Ratio (OR)|0.61|||||2-Sided|95.0|0.18|2.12|||||6-12 years Row (<1 Ref)||
1594208|NCT02997735|2931373|Superiority||Odds Ratio (OR)|7.78|||<|0.001|2-Sided|95.0|2.81|27.9|||Chi-squared||ORs from multivariable logistic regression model of characteristics associated with successful quitline enrollment.||
1594209|NCT02997163|2931405|Superiority||Percent Ratio of Geometric Means|206.07|||||2-Sided|90.0|139.91|303.51|||||||
1594210|NCT02997163|2931405|Superiority||Percent Ratio of Geometric Means|128.22|||||2-Sided|90.0|88.05|186.72|||||||
1594211|NCT02997163|2931405|Superiority||Percent Ratio of Geometric Means|117.45|||||2-Sided|90.0|79.74|172.99|||||||
1594212|NCT02997163|2931406|Superiority||Percent Ratio of Geometric Means|286.61|||||2-Sided|90.0|202.66|405.33|||||||
1594213|NCT02997163|2931406|Superiority||Percent Ratio of Geometric Means|139.34|||||2-Sided|90.0|99.53|195.06|||||||
1594214|NCT02997163|2931406|Superiority||Percent Ratio of Geometric Means|118.58|||||2-Sided|90.0|83.85|167.7|||||||
1594215|NCT02997163|2931407|Superiority||Percent Ratio of Geometric Means|189.32|||||2-Sided|90.0|126.74|282.8|||||||
1594216|NCT02997163|2931407|Superiority||Percent Ratio of Geometric Means|131.57|||||2-Sided|90.0|89.12|194.25|||||||
1594217|NCT02997163|2931407|Superiority||Percent Ratio of Geometric Means|111.13|||||2-Sided|90.0|74.4|166.01|||||||
1594218|NCT02997163|2931408|Superiority||Percent Ratio of Geometric Means|263.32|||||2-Sided|90.0|187.88|369.06|||||||
1594219|NCT02997163|2931408|Superiority||Percent Ratio of Geometric Means|142.98|||||2-Sided|90.0|103.03|198.42|||||||
1594220|NCT02997163|2931408|Superiority||Percent Ratio of Geometric Means|112.2|||||2-Sided|90.0|80.06|157.26|||||||
1594221|NCT02996968|2931409|Non-Inferiority|"Non-inferiority was declared if the POUR rate at 1-week with self-discontinuation was no worse than the POUR rate at 1-week with office-discontinuation, by a pre-specified margin of 15%.~A sample size was calculated to be 74 patients in each arm based on the following:~The estimated POUR requiring indwelling urinary catheter at 1-week postoperative is 16%~The non-inferiority margin was set at 15%.~The power was set at 80%"|Proportion Difference|0.002||||0.5|1-Sided|95.0||0.095||2-sample test for equality of proportions with continuity correction|Two proportions Z-test||||
1594222|NCT02996682|2931418|Superiority||||||<|0.001||||||P-value was from the 2-sided exact 1-sample binomial test for the superiority of each treatment group over pre-specified rate of 1%.|2-sided exact 1-sample binomial test|||A sample size of 50 participants in each treatment group would provide over 99% power to detect at least 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.025.|
1594223|NCT02996682|2931418|Superiority||||||<|0.001||||||P-value was from the 2-sided exact 1-sample binomial test for the superiority of each treatment group over pre-specified rate of 1%.|2-sided exact 1-sample binomial test|||A sample size of 50 participants in each treatment group would provide over 99% power to detect at least 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.025.|
1594224|NCT02996591|2931424|Other|Bang blinding index|||||<|0.001|||||||Bang Blinding Index|95% confidence interval|||
1594225|NCT02996591|2931424|Other||generalized estimating equations method|45.0|||<|0.038|2-Sided||||||Regression, Logistic||||
1594226|NCT02996500|2931474|Superiority||Mean Difference (Net)|-11.29|||<|0.001|2-Sided|95.0|-16.62|-5.92|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.|
1594227|NCT02996500|2931474|Superiority||Median Difference (Net)|-10.89|||<|0.001|2-Sided|95.0|-16.36|-5.63|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.|
1594228|NCT02996500|2931474|Superiority||Mean Difference (Net)|-8.96|||<|0.001|2-Sided|95.0|-14.37|-3.66|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.|
1594229|NCT02996500|2931474|Superiority||Mean Difference (Net)|-7.83|||<|0.005|2-Sided|95.0|-13.73|-1.97|||ANCOVA|Bayesian analysis of covariance (ANCOVA) modeling framework was used with baseline SDAI score as a covariate.||The confidence interval was credible interval in this analysis.|
1594230|NCT02993302|2931557|Other|||||||0.53|||||||Wilcoxon (Mann-Whitney)||||
1594231|NCT02993302|2931558|Other|||||||0.47|||||||Wilcoxon (Mann-Whitney)||||
1594232|NCT02993302|2931559|Other|||||||0.48|||||||Wilcoxon (Mann-Whitney)||||
1594233|NCT02992691|2931570|Other||Mean Difference (Net)|-0.01||||0.6674|2-Sided|95.0|-0.06|0.04||From ANCOVA analysis for change from pre-brushing with treatment and period as fixed effect, participant as random effect, participant-level baseline and period level minus participant-level baseline as covariates.|ANCOVA|||This comparison was tested under a null hypothesis of no difference against alternative hypothesis of a difference between treatments|
1594234|NCT02992288|2931574|Superiority|||||||0.9959||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594235|NCT02992288|2931574|Superiority|||||||0.9982||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594236|NCT02992288|2931574|Superiority|||||||0.9913||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594237|NCT02992288|2931574|Superiority|||||||0.9946||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594238|NCT02992288|2931574|Superiority|||||||0.9955||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594239|NCT02992288|2931575|Superiority|||||||0.8036||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594240|NCT02992288|2931575|Superiority|||||||0.6923||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594241|NCT02992288|2931575|Superiority|||||||0.6506||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594242|NCT02992288|2931575|Superiority|||||||0.8253||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594243|NCT02992288|2931575|Superiority|||||||0.5703||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594244|NCT02992288|2931576|Superiority|||||||0.7303||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594245|NCT02992288|2931576|Superiority|||||||0.5338||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594246|NCT02992288|2931576|Superiority|||||||0.5562||||||Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594247|NCT02992288|2931576|Superiority|||||||0.7859||||||Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594248|NCT02992288|2931576|Superiority|||||||0.4596||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594249|NCT02992288|2931577|Superiority|||||||0.9083||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594250|NCT02992288|2931577|Superiority|||||||0.7357||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594251|NCT02992288|2931577|Superiority|||||||0.9296||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594252|NCT02992288|2931577|Superiority|||||||0.9233||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594253|NCT02992288|2931577|Superiority|||||||0.8966||||||Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594254|NCT02992288|2931578|Superiority|||||||0.3842||||||Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594255|NCT02992288|2931578|Superiority|||||||0.2534||||||Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594256|NCT02992288|2931578|Superiority|||||||0.2842||||||Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594257|NCT02992288|2931578|Superiority|||||||0.4409||||||Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594258|NCT02992288|2931578|Superiority|||||||0.2297||||||Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided one-sided p-values of the contrast test.|MCP-Mod method|Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.|||
1594259|NCT02992236|2931581|Superiority||||||<|0.0001|||||||Mixed Models Analysis||||
1594260|NCT02992132|2931583|Superiority||Difference in LSM|1.0|Standard Error of the Mean|4.8|||2-Sided|95.0|-8.5|10.5||||||Mixed-effect model repeated measures (MMRM), with the dependent variable being the change from Baseline in CMAI total score.|
1594261|NCT02992132|2931583|Superiority||Difference in LSM|5.1|Standard Error of the Mean|5.0|||2-Sided|95.0|-4.8|15.0||||||Mixed-effect model repeated measures (MMRM), with the dependent variable being the change from Baseline in CMAI total score.|
1594262|NCT02991859|2931637|Other||Emax Model|5869.45|||||2-Sided|95.0|2186.03|15759.35|||||ED80 for AMP PC20||
1594263|NCT02991859|2931637|Other||Emax Model|620.49|||||2-Sided|95.0|546.79|694.2|||||ED20 for Cortisol Suppression 0-24 Hours Weighted Mean||
1594264|NCT02991859|2931638|Other||Emax Model|4325.07|||||2-Sided|95.0|1792.02|10438.64|||||ED80 for AMP PC20||
1594265|NCT02991859|2931638|Other||Emax Model|639.36|||||2-Sided|95.0|506.94|771.79|||||ED20 for Cortisol Suppression 0-24 Hours Weighted Mean||
1594266|NCT02991859|2931639|Other||Emax Model|194.09|||||2-Sided|95.0|72.82|517.28|||||ED80 for AMP PC20||
1594267|NCT02991859|2931639|Other||Emax Model|289.73|||||2-Sided|95.0|224.82|354.64|||||ED20 Cortisol Suppression 0-24 Hours Weighted Mean||
1594268|NCT02991859|2931640|Other||exponential power-law model|1927.42|||||2-Sided|95.0|1698.47|2156.37|||||BUD ED50 - Dose at which 50% of the maximum dose response reached (mcg)||
1594269|NCT02991859|2931640|Other||exponential power-law model|176.09|||||2-Sided|95.0|162.87|190.38|||||BUD E0 - Response of Placebo participants||
1594270|NCT02991859|2931640|Other||exponential power-law model|1986.05|||||2-Sided|95.0|1574.7|2397.39|||||FP ED50 - Dose at which 50% of the maximum dose response reached (mcg)||
1594271|NCT02991859|2931640|Other||exponential power-law model|176.09|||||2-Sided|95.0|162.87|190.38|||||FP E0-Response of Placebo participants||
1594272|NCT02991859|2931640|Other||exponential power-law model|899.99|||||2-Sided|95.0|698.36|1101.62|||||FF ED50 Dose at which 50% of the maximum dose response reached||
1594273|NCT02991859|2931640|Other||Exponential power-law model|176.09|||||2-Sided|95.0|162.87|190.38|||||FF E0-Response of Placebo participants||
1594274|NCT02991859|2931641|Other||3 parameter Emax model|1467.36|||||2-Sided|95.0|546.51|3939.84|||||BUD ED50-Dose at which 50% of the maximum dose response reached (mcg)||
1594275|NCT02991859|2931641|Other||3 parameter Emax model|14.44|||||2-Sided|95.0|8.21|25.4|||||BUD Emax-Maximum Dose response||
1594276|NCT02991859|2931641|Other||3 parameter Emax model|13.5|||||2-Sided|95.0|9.39|19.39|||||BUD E0-Response of Placebo participants||
1594277|NCT02991859|2931641|Other||3 parameter Emax model|1081.27|||||2-Sided|95.0|448.0|2609.66|||||FP ED50-Dose at which 50% of the maximum dose response reached (mcg)||
1594278|NCT02991859|2931641|Other||3 parameter Emax model|14.44|||||2-Sided|95.0|8.21|25.4|||||FP Emax-Maximum Dose response||
1594279|NCT02991859|2931641|Other||3 parameter Emax model|13.5|||||2-Sided|95.0|9.39|19.39|||||FP E0-Response of Placebo participants||
1594280|NCT02991859|2931641|Other||3 parameter Emax model|48.52|||||2-Sided|95.0|18.21|129.32|||||ED50-Dose at which 50% of the maximum dose response reached (mcg)||
1594281|NCT02991859|2931641|Other||3 parameter Emax model|14.44|||||2-Sided|95.0|8.21|25.4|||||Emax-Maximum Dose response||
1594282|NCT02991859|2931641|Other||3 parameter Emax model|13.5|||||2-Sided|95.0|9.39|19.39|||||FF E0 (Response of Placebo participants)||
1594283|NCT02991729|2931646|Superiority|||||||0.369|||||||Wilcoxon rank-sum|||This was measured in 2 separate time points in the experimental group - both prior to and following genetic counseling. These rows compare the routine care group (where conflict was assessed after counseling only) to the experimental group both prior to genetic counseling (first row) and following genetic counseling (second row).|
1594284|NCT02991729|2931647|Non-Inferiority|The non-inferiority limit was 1 point on the questionnaire scale.||||||0.929||||||a priori threshold for statistical significance was p<0.05.|Wilcoxon rank-sum||||
1594285|NCT02991118|2931666|Superiority||Difference in LS mean|-15.07|Standard Error of the Mean|2.641|<|0.001|2-Sided|95.0|-20.26|-9.878|||ANCOVA||||
1594286|NCT02991118|2931667|Superiority||Location shift|-7.587||||0.102|2-Sided|95.0|-16.978|1.653|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.||
1594287|NCT02991118|2931668|Superiority||Location shift|-21.278|||<|0.001|2-Sided|95.0|-32.25|-10.034|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.||
1594288|NCT02991118|2931669|Superiority||Difference in LS mean|-9.58|Standard Error of the Mean|1.796|<|0.001|2-Sided|95.0|-13.107|-6.047|||ANCOVA||||
1594289|NCT02991118|2931670|Superiority||Difference in LS mean|-13.0|Standard Error of the Mean|2.451|<|0.001|2-Sided|95.0|-17.829|-8.175|||ANCOVA||||
1594290|NCT02991118|2931671|Superiority||Difference in LS mean|-8.36|Standard Error of the Mean|1.458|<|0.001|2-Sided|95.0|-11.223|-5.493|||ANCOVA||||
1594291|NCT02991118|2931672|Superiority||Difference in LS mean|-10.77|Standard Error of the Mean|1.489|<|0.001|2-Sided|95.0|-13.698|-7.848|||ANCOVA||||
1594292|NCT02991118|2931673|Superiority||Difference in LS mean|-9.92|Standard Error of the Mean|1.976|<|0.001|2-Sided|95.0|-13.803|-6.037|||ANCOVA||||
1594293|NCT02991118|2931674|Superiority||Difference in LS mean|-12.63|Standard Error of the Mean|2.01|<|0.001|2-Sided|95.0|-16.58|-8.682|||ANCOVA||||
1594294|NCT02991118|2931675|Superiority||Difference in LS mean|-12.27|Standard Error of the Mean|2.314|<|0.001|2-Sided|95.0|-16.813|-7.722|||ANCOVA||||
1594295|NCT02991118|2931676|Superiority||Difference in LS mean|-6.13|Standard Error of the Mean|1.139|<|0.001|2-Sided|95.0|-8.369|-3.896|||ANCOVA||||
1594296|NCT02991118|2931677|Superiority||Difference in LS mean|4.89|Standard Error of the Mean|3.258||0.134|2-Sided|95.0|-1.504|11.292|||ANCOVA||||
1594297|NCT02991118|2931680|Superiority||Location shift|-8.733|||<|0.039|2-Sided|95.0|-17.238|-0.434|||Wilcoxon Rank Sum Test||The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.||
1594298|NCT02991118|2931681|Superiority||Difference in LS mean|-13.02|Standard Error of the Mean|1.587|<|0.001|2-Sided|95.0|-16.13|-9.907|||ANCOVA||||
1594299|NCT02991118|2931682|Superiority||Difference in LS mean|-11.2|Standard Error of the Mean|1.224|<|0.001|2-Sided|95.0|-13.599|-8.801|||ANCOVA||||
1594300|NCT02991118|2931683|Superiority||Difference in LS mean|-13.03|Standard Error of the Mean|1.652|<|0.001|2-Sided|95.0|-16.27|-9.794|||ANCOVA||||
1594301|NCT02991118|2931684|Superiority||Difference in LS mean|-14.77|Standard Error of the Mean|2.418|<|0.001|2-Sided|95.0|-19.504|-10.027|||ANCOVA||||
1594302|NCT02991118|2931685|Superiority||Difference in LS mean|-17.42|Standard Error of the Mean|1.8|<|0.001|2-Sided|95.0|-20.951|-13.896|||ANCOVA||||
1594303|NCT02990910|2931693|Superiority||||||<|0.05|||||||Chi-squared|||Chi square test was used to compare the count data,p < 0.05 was considered statistically significant.|
1594304|NCT02990338|2931715|Superiority|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|Hazard Ratio (HR)|0.687||||0.0631|2-Sided|95.0|0.461|1.023||One-sided significance level was 0.0008 using the O'Brien-Fleming alpha spending function.|Log Rank|Stratified on age (<75 years versus >=75 years) and number of previous lines of therapy (2 or 3 versus > 3) according to IRT.||CI for Kaplan-Meier estimates are calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.|
1594305|NCT02990338|2931716|Superiority|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|||||<|0.0001||||||Threshold for statistical significance at 0.025.|Cochran-Mantel-Haenszel|One sided p-value was stratified based on age (<75 years versus >=75 years) and number of previous lines (2 or 3 versus >3) according to IRT.|||
1594306|NCT02990338|2931717|Superiority|A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.|Hazard Ratio (HR)|0.596||||0.001|2-Sided|95.0|0.436|0.814||One-sided p-value based on Stratified log-rank test. Threshold for statistical significance at 0.025.|Log Rank|Stratification was based on age (<75 years versus >=75 years) and number of previous lines of therapy (2 or 3 versus >3) according to IRT.||Confidence interval (CI) for Kaplan-Meier estimates were calculated with log-log transformation of survival function and methods of Brookmeyer and Crowley.|
1594307|NCT02989727|2931729|Superiority||Cox Proportional Hazard|1.05|Standard Error of the Mean|0.13||0.73|2-Sided||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response."|
1594308|NCT02989727|2931729|Superiority||Cox Proportional Hazard|1.27|Standard Error of the Mean|0.11||0.02|2-Sided||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response."|
1594309|NCT02989727|2931737|Superiority||Cox Proportional Hazard|1.08|Standard Error of the Mean|0.12||0.53|2-Sided||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response."|
1594310|NCT02989727|2931737|Superiority||Cox Proportional Hazard|1.2|Standard Error of the Mean|0.1||0.08|2-Sided||||||Regression, Cox|||"Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response."|
1594311|NCT02989727|2931738|Superiority||ANOVA estimate|0.5|Standard Error of the Mean|2.56||0.84|2-Sided||||||ANOVA|||Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.|
1594312|NCT02989727|2931739|Superiority||ANOVA estimate|1.88|Standard Error of the Mean|3.51||0.59|2-Sided||||||ANOVA|||Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.|
1594313|NCT02989649|2931748|Other||Least Square Mean|-1.25|Standard Error of the Mean|0.098|||2-Sided|95.0|-1.44|-1.05|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6|
1594314|NCT02989649|2931748|Other||Least Square Mean (LSM)|-0.95|Standard Error of the Mean|0.117|||2-Sided|95.0|-1.18|-0.72|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 3|
1594315|NCT02989649|2931749|Other||Least Square Mean (LSM)|-0.87|Standard Error of the Mean|0.245|||2-Sided|95.0|-1.36|-0.39|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6|
1594316|NCT02989649|2931749|Other||Least Square Mean (LSM)|-0.95|Standard Error of the Mean|0.17|||2-Sided|95.0|-1.29|-0.62|||||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 3|
1594317|NCT02989649|2931752|Other||||||<|0.001|||||||Regression, Linear|||Statistical analysis for subgroup: Initial glycemic control, <7% or >=7%|
1594318|NCT02989649|2931752|Other||||||<|0.847|||||||Regression, Linear|||Statistical analysis for subgroup: Baseline BMI, <25 or 25 to <30 or >=30 kg/m^2|
1594319|NCT02989649|2931752|Other||||||<|0.841|||||||Regression, Linear|||Statistical analysis for subgroup: Therapy type, Monotherapy or Combined therapy|
1594320|NCT02989649|2931752|Other||||||<|0.99|||||||Regression, Linear|||Statistical analysis for subgroup: Cardiovascular risk group, Yes or No|
1594321|NCT02989649|2931752|Other||||||<|0.001|||||||Regression, Linear|||Statistical analysis for subgroup: Age, <45 or >=45 to <65 years or >=65 years|
1594322|NCT02989649|2931752|Other||||||<|0.747|||||||Regression, Linear|||Statistical analysis for subgroup: Sex, Male or Female|
1594323|NCT02989649|2931752|Other||||||<|0.423|||||||Regression, Linear|||Statistical analysis for subgroup: Prior therapy of diabetes mellitus, Ever used or Never used|
1594362|NCT02987972|2931789|Other||GMC Ratio|0.66|||||2-Sided|95.0|0.58|0.76|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A|
1594324|NCT02989649|2931753|Other||Least Square Mean (LSM)|-1.25|Standard Error of the Mean|0.098|<|0.001|2-Sided|95.0|-1.44|-1.05|||Regression, Linear||The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.|Statistical analysis for data at Baseline compared to the data at Month 6|
1594325|NCT02989389|2931760|Superiority||Mean Difference (Final Values)|-84.56|||<|0.001|2-Sided|90.0|-88.97|-78.38|||Mixed Models Analysis|||Aβ 1-42|
1594326|NCT02989389|2931760|Superiority||Mean Difference (Final Values)|-65.41|||<|0.001|2-Sided|90.0|-72.23|-56.92|||Mixed Models Analysis|||Aβ 1-42|
1594327|NCT02989389|2931760|Superiority||Mean Difference (Final Values)|-19.6|||<|0.015|2-Sided|90.0|-33.69|-2.51|||Mixed Models Analysis|||Aβ 1-42|
1594328|NCT02989389|2931760|Superiority||Mean Difference (Final Values)|-87.07|||<|0.001|2-Sided|90.0|-90.21|-82.92|||Mixed Models Analysis|||Aβ 1-40|
1594329|NCT02989389|2931760|Superiority||Mean Difference (Final Values)|-60.53|||<|0.001|2-Sided|90.0|-69.79|-48.43|||Mixed Models Analysis|||Aβ 1-40|
1594330|NCT02989389|2931760|Superiority||Mean Difference (Final Values)|-11.57|||<|0.215|2-Sided|90.0|-29.52|10.96|||Mixed Models Analysis|||Aβ 1-40|
1594331|NCT02988622|2931770|Superiority||Mean Difference (Net)|0.3824|Standard Deviation|1.5685||0.0281|2-Sided||||||t-test, 2 sided||||
1594332|NCT02988622|2931772|Superiority||Mean Difference (Net)|0.2375|Standard Deviation|1.5528||0.1752|2-Sided||||||t-test, 2 sided||||
1594333|NCT02988622|2931773|Superiority||Mean Difference (Net)|0.2195|Standard Deviation|2.0788||0.3418|2-Sided||||||t-test, 2 sided||||
1594334|NCT02988622|2931774|Superiority||Mean Difference (Net)|0.3373|Standard Deviation|1.7619||0.0848|2-Sided||||||t-test, 2 sided||||
1594335|NCT02988622|2931775|Superiority||Mean Difference (Net)|-0.0843|Standard Deviation|1.5789||0.6278|2-Sided||||||t-test, 2 sided||||
1594336|NCT02988622|2931776|Superiority||Mean Difference (Net)|0.3659|Standard Deviation|1.7951||0.0686|2-Sided||||||t-test, 2 sided||||
1594337|NCT02988622|2931777|Superiority||Mean Difference (Net)|0.241|Standard Deviation|0.0817||0.0817|2-Sided||||||t-test, 2 sided||||
1594338|NCT02988622|2931778|Superiority||Mean Difference (Net)|0.1205|Standard Deviation|0.5499||0.0492|2-Sided||||||t-test, 2 sided||||
1594339|NCT02988219|2931781|Superiority or Other|||||||0.0174|||||||Chi-squared|||long QTc > 0.24 s in the perioperative time|
1594340|NCT02988219|2931781|Superiority or Other|||||||0.077|||||||Chi-squared|||long QTc > 0.45s after surgery|
1594341|NCT02988219|2931781|Superiority or Other|||||||0.6544|||||||Chi-squared|||arrhythmia after surgery|
1594342|NCT02988219|2931781|Superiority or Other|||||||0.4|||||||Chi-squared|||arrhythmia during surgery|
1594343|NCT02988219|2931781|Superiority or Other|||||||0.597|||||||Chi-squared|||Arrhythmia before surgery|
1594344|NCT02988219|2931782|Superiority or Other|||||||0.2591|||||||Chi-squared|||No bradycardia observed in the perioperative period|
1594345|NCT02988219|2931782|Superiority or Other|||||||0.3861|||||||Chi-squared|||Bradycardia during surgery|
1594346|NCT02988115|2931785|Superiority||Median treatment difference|-24.29|Standard Error of the Mean|-24.3|<|0.001|2-Sided|95.0|-35.888|-12.712|||Wilcoxon rank sum test||BA therapy minus placebo||
1594347|NCT02988115|2931786|Superiority||Least squares means difference|-14.96|Standard Error of the Mean|1.581|<|0.001|2-Sided|95.0|-18.062|-11.866|||ANCOVA||BA therapy minus placebo|apoB|
1594348|NCT02988115|2931786|Superiority||Least squares means difference|-14.76|Standard Error of the Mean|1.287|<|0.001|2-Sided|95.0|-17.283|-12.239|||ANCOVA||BA therapy minus placebo|TC|
1594349|NCT02988115|2931786|Superiority||Least squares means difference|-17.94|Standard Error of the Mean|1.597|<|0.001|2-Sided|95.0|-21.07|-14.811|||ANCOVA||BA therapy minus placebo|non-HDL-C|
1594350|NCT02988115|2931787|Superiority||Least squares means difference|-18.91|Standard Error of the Mean|2.063|<|0.001|2-Sided|95.0|-22.951|-14.865|||ANCOVA||BA therapy minus placebo||
1594351|NCT02988115|2931788|Superiority||Least squares means difference|-21.41|Standard Error of the Mean|1.897|<|0.001|2-Sided|95.0|-25.132|-17.697|||ANCOVA||bempedoic acid (BA) therapy minus placebo||
1594352|NCT02987972|2931789|Other||GMC Ratio|78.99|||||2-Sided|95.0|69.82|89.36|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F|
1594353|NCT02987972|2931789|Other||GMC Ratio|131.23|||||2-Sided|95.0|114.05|151.0|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F|
1594354|NCT02987972|2931789|Other||GMC Ratio|0.92|||||2-Sided|95.0|0.79|1.08|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F|
1594355|NCT02987972|2931789|Other||GMC Ratio|0.9|||||2-Sided|95.0|0.79|1.03|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F|
1594356|NCT02987972|2931789|Other||GMC Ratio|0.82|||||2-Sided|95.0|0.72|0.93|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A|
1594357|NCT02987972|2931789|Other||GMC Ratio|1.07|||||2-Sided|95.0|0.93|1.24|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C|
1594358|NCT02987972|2931789|Other||GMC Ratio|0.85|||||2-Sided|95.0|0.73|0.98|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14|
1594359|NCT02987972|2931789|Other||GMC Ratio|0.77|||||2-Sided|95.0|0.67|0.88|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V|
1594360|NCT02987972|2931789|Other||GMC Ratio|0.71|||||2-Sided|95.0|0.62|0.81|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F|
1594361|NCT02987972|2931789|Other||GMC Ratio|0.83|||||2-Sided|95.0|0.72|0.95|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B|
1594363|NCT02987972|2931789|Other||GMC Ratio|0.69|||||2-Sided|95.0|0.6|0.79|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5|
1594364|NCT02987972|2931789|Other||GMC Ratio|0.81|||||2-Sided|95.0|0.7|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4|
1594365|NCT02987972|2931789|Other||GMC Ratio|1.48|||||2-Sided|95.0|1.31|1.68|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3|
1594366|NCT02987972|2931789|Other||GMC Ratio|0.81|||||2-Sided|95.0|0.71|0.93|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1|
1594367|NCT02987972|2931789|Other||GMC Ratio|90.35|||||2-Sided|95.0|79.93|102.12|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F|
1594368|NCT02987972|2931789|Other||GMC Ratio|149.69|||||2-Sided|95.0|130.23|172.06|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F|
1594369|NCT02987972|2931789|Other||GMC Ratio|0.75|||||2-Sided|95.0|0.64|0.87|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F|
1594370|NCT02987972|2931789|Other||GMC Ratio|0.97|||||2-Sided|95.0|0.85|1.1|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F|
1594371|NCT02987972|2931789|Other||GMC Ratio|0.89|||||2-Sided|95.0|0.78|1.01|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A|
1594372|NCT02987972|2931789|Other||GMC Ratio|0.93|||||2-Sided|95.0|0.81|1.08|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C|
1594373|NCT02987972|2931789|Other||GMC Ratio|0.88|||||2-Sided|95.0|0.76|1.02|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14|
1594374|NCT02987972|2931789|Other||GMC Ratio|0.69|||||2-Sided|95.0|0.6|0.79|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V|
1594375|NCT02987972|2931789|Other||GMC Ratio|0.67|||||2-Sided|95.0|0.59|0.77|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F|
1594376|NCT02987972|2931789|Other||GMC Ratio|1.07|||||2-Sided|95.0|0.93|1.22|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B|
1594377|NCT02987972|2931789|Other||GMC Ratio|0.72|||||2-Sided|95.0|0.62|0.82|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A|
1594378|NCT02987972|2931789|Other||GMC Ratio|0.73|||||2-Sided|95.0|0.63|0.84|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5|
1594379|NCT02987972|2931789|Other||GMC Ratio|0.88|||||2-Sided|95.0|0.76|1.02|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4|
1594380|NCT02987972|2931789|Other||GMC Ratio|1.44|||||2-Sided|95.0|1.27|1.63|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3|
1594381|NCT02987972|2931789|Other||GMC Ratio|0.71|||||2-Sided|95.0|0.62|0.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1|
1594382|NCT02987972|2931790|Other||GMC Ratio|24.1|||||2-Sided|95.0|21.32|27.25|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F|
1594383|NCT02987972|2931790|Other||GMC Ratio|26.3|||||2-Sided|95.0|23.31|29.68|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F|
1594384|NCT02987972|2931790|Other||GMC Ratio|1.16|||||2-Sided|95.0|0.99|1.35|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F|
1594385|NCT02987972|2931790|Other||GMC Ratio|0.83|||||2-Sided|95.0|0.73|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F|
1594386|NCT02987972|2931790|Other||GMC Ratio|0.82|||||2-Sided|95.0|0.71|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A|
1594387|NCT02987972|2931790|Other||GMC Ratio|1.2|||||2-Sided|95.0|1.07|1.34|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C|
1594388|NCT02987972|2931790|Other||GMC Ratio|0.61|||||2-Sided|95.0|0.53|0.7|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14|
1594389|NCT02987972|2931790|Other||GMC Ratio|0.86|||||2-Sided|95.0|0.76|0.97|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V|
1594390|NCT02987972|2931790|Other||GMC Ratio|0.78|||||2-Sided|95.0|0.7|0.86|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F|
1597184|NCT02915835|2935804|Superiority|||||||1|||||||Fisher Exact||||
1594391|NCT02987972|2931790|Other||GMC Ratio|1.12|||||2-Sided|95.0|0.97|1.28|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B|
1594392|NCT02987972|2931790|Other||GMC Ratio|0.65|||||2-Sided|95.0|0.57|0.74|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A|
1594393|NCT02987972|2931790|Other||GMC Ratio|0.86|||||2-Sided|95.0|0.77|0.95|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5|
1594394|NCT02987972|2931790|Other||GMC Ratio|0.94|||||2-Sided|95.0|0.85|1.05|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4|
1594395|NCT02987972|2931790|Other||GMC Ratio|2.1|||||2-Sided|95.0|1.84|2.39|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3|
1594396|NCT02987972|2931790|Other||GMC ratio|0.77|||||2-Sided|95.0|0.69|0.85|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1|
1594397|NCT02987972|2931790|Other||GMC Ratio|25.57|||||2-Sided|95.0|22.61|28.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F|
1594398|NCT02987972|2931790|Other||GMC Ratio|27.82|||||2-Sided|95.0|24.64|31.4|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|type 22F|
1594399|NCT02987972|2931790|Other||GMC Ratio|0.92|||||2-Sided|95.0|0.79|1.07|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F|
1594400|NCT02987972|2931790|Other||GMC Ratio|0.74|||||2-Sided|95.0|0.65|0.85|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F|
1594401|NCT02987972|2931790|Other||GMC Ratio|0.79|||||2-Sided|95.0|0.69|0.91|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A|
1594402|NCT02987972|2931790|Other||GMC Ratio|0.8|||||2-Sided|95.0|0.72|0.9||||||Type 18C|IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
1594403|NCT02987972|2931790|Other||GMC Ratio|0.66|||||2-Sided|95.0|0.58|0.76|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14|
1594404|NCT02987972|2931790|Other||GMC Ratio|0.84|||||2-Sided|95.0|0.74|0.95|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V|
1594405|NCT02987972|2931790|Other||GMC Ratio|0.74|||||2-Sided|95.0|0.67|0.82|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F|
1594406|NCT02987972|2931790|Other||GMC Ratio|1.21|||||2-Sided|95.0|1.06|1.39|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B|
1594407|NCT02987972|2931790|Other||GMC Ratio|0.57|||||2-Sided|95.0|0.5|0.65|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A|
1594408|NCT02987972|2931790|Other||GMC Ratio|0.87|||||2-Sided|95.0|0.78|0.96|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5|
1594409|NCT02987972|2931790|Other||GMC Ratio|0.96|||||2-Sided|95.0|0.86|1.07|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4|
1594410|NCT02987972|2931790|Other||GMC Ratio|2.0|||||2-Sided|95.0|1.75|2.28|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3|
1594411|NCT02987972|2931790|Other||GMC Ratio|0.69|||||2-Sided|95.0|0.62|0.76|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1|
1594412|NCT02987972|2931791|Other||Difference in Percentages|2.6||||0.235|2-Sided|95.0|-1.7|7.0|||Miettinen and Nurminen||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.||
1594413|NCT02987972|2931791|Other||Difference in Percentages|0.7||||0.772|2-Sided|95.0|-3.9|5.2|||Miettinen and Nurminen||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.||
1594414|NCT02987972|2931792|Other||Difference in Percentages|6.3|||||2-Sided|95.0|-0.2|12.9|||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™.||
1594415|NCT02987972|2931792|Other||Difference in Percentages|6.3|||||2-Sided|95.0|-0.3|12.8|||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™.||
1594416|NCT02987972|2931793|Other||Difference in Percentages|0.3|||||2-Sided|95.0|-0.8|1.6||||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.|
1594417|NCT02987972|2931793|Other||Difference in Percentages|0.3|||||2-Sided|95.0|-0.8|1.6||||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.|
1594418|NCT02987972|2931794|Other||Difference in Percentages|2.0|||||2-Sided|95.0|-0.7|5.0||||||Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.|
1594419|NCT02987972|2931794|Other||Difference in Percentages|0.0|||||2-Sided|95.0|-3.1|3.2||||||Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.|
1594927|NCT02977507|2932348|Other|||||||0.0001|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.|
1594420|NCT02987972|2931795|Other||GMC Ratio|32.92|||||2-Sided|95.0|27.25|39.78|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F|
1594421|NCT02987972|2931795|Other||GMC Ratio|80.09|||||2-Sided|95.0|70.3|91.24|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F|
1594422|NCT02987972|2931795|Other||GMC Ratio|1.18|||||2-Sided|95.0|1.01|1.37|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F|
1594423|NCT02987972|2931795|Other||GMC Ratio|0.91|||||2-Sided|95.0|0.81|1.01|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F|
1594424|NCT02987972|2931795|Other||GMC Ratio|0.82|||||2-Sided|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A|
1594425|NCT02987972|2931795|Other||GMC Ratio|0.99|||||2-Sided|95.0|0.88|1.12|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C|
1594426|NCT02987972|2931795|Other||GMC Ratio|0.83|||||2-Sided|95.0|0.71|0.97|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14|
1594427|NCT02987972|2931795|Other||GMC Ratio|1.07|||||2-Sided|95.0|0.94|1.22|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V|
1594428|NCT02987972|2931795|Other||GMC Ratio|0.81|||||2-Sided|95.0|0.72|0.91|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F|
1594429|NCT02987972|2931795|Other||GMC Ratio|0.9|||||2-Sided|95.0|0.74|1.1|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B|
1594430|NCT02987972|2931795|Other||GMC Ratio|0.57|||||2-Sided|95.0|0.49|0.66|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A|
1594431|NCT02987972|2931795|Other||GMC Ratio|0.83|||||2-Sided|95.0|0.72|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5|
1594432|NCT02987972|2931795|Other||GMC Ratio|1.01|||||2-Sided|95.0|0.9|1.14|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4|
1594433|NCT02987972|2931795|Other||GMC Ratio|1.93|||||2-Sided|95.0|1.71|2.18|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3|
1594434|NCT02987972|2931795|Other||GMC Ratio|0.83|||||2-Sided|95.0|0.74|0.94|||||IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1|
1594435|NCT02987972|2931795|Other||GMC Ratio|34.41|||||2-Sided|95.0|28.5|41.54|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 33F|
1594436|NCT02987972|2931795|Other||GMC Ratio|92.05|||||2-Sided|95.0|80.84|104.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 22F|
1594437|NCT02987972|2931795|Other||GMC Ratio|0.98|||||2-Sided|95.0|0.84|1.13|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 23F|
1594438|NCT02987972|2931795|Other||GMC Ratio|0.88|||||2-Sided|95.0|0.79|0.98|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19F|
1594439|NCT02987972|2931795|Other||GMC Ratio|0.82|||||2-Sided|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 19A|
1594440|NCT02987972|2931795|Other||GMC Ratio|0.75|||||2-Sided|95.0|0.66|0.84|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 18C|
1594441|NCT02987972|2931795|Other||GMC Ratio|0.88|||||2-Sided|95.0|0.75|1.03|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 14|
1594442|NCT02987972|2931795|Other||GMC Ratio|0.88|||||2-Sided|95.0|0.77|1.0|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 9V|
1594443|NCT02987972|2931795|Other||GMC Ratio|0.82|||||2-Sided|95.0|0.73|0.92|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 7F|
1594444|NCT02987972|2931795|Other||GMC Ratio|1.03|||||2-Sided|95.0|0.84|1.26|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6B|
1594445|NCT02987972|2931795|Other||GMC Ratio|0.54|||||2-Sided|95.0|0.47|0.63|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 6A|
1594446|NCT02987972|2931795|Other||GMC Ratio|0.78|||||2-Sided|95.0|0.68|0.89|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 5|
1594447|NCT02987972|2931795|Other||GMC Ratio|1.04|||||2-Sided|95.0|0.92|1.16|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 4|
1610773|NCT02544607|2958783|Other||||||<|0.01|||||||t-test, 2 sided||||
1594448|NCT02987972|2931795|Other||GMC Ratio|1.98|||||2-Sided|95.0|1.75|2.23|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 3|
1594449|NCT02987972|2931795|Other||GMC Ratio|0.72|||||2-Sided|95.0|0.64|0.81|||||IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.|Type 1|
1594450|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|4.2|||<|0.001|2-Sided|95.0|-0.1|8.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 23F|
1594451|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.8|||<|0.001|2-Sided|95.0|-2.9|0.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 19F|
1594452|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.1|||<|0.001|2-Sided|95.0|-2.5|2.2|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 19A|
1594453|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.6|||<|0.001|2-Sided|95.0|-0.3|5.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 18C|
1594454|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.2|||<|0.001|2-Sided|95.0|-2.8|3.1|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 14|
1594455|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.0|||<|0.001|2-Sided|95.0|-1.1|5.2|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 9V|
1594456|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|2-Sided|95.0|-1.7|2.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 7F|
1594457|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.9|||<|0.001|2-Sided|95.0|-3.7|5.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 6B|
1594458|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.6|||<|0.001|2-Sided|95.0|-4.2|2.8|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 6A|
1594459|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.6|||<|0.001|2-Sided|95.0|-4.1|2.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 5|
1594460|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.9|||<|0.001|2-Sided|95.0|-1.4|5.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 4|
1594461|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|22.3|||<|0.001|2-Sided|95.0|16.5|28.3|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 3|
1594462|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.9|||<|0.001|2-Sided|95.0|-2.0|3.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™|Type 1|
1594463|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.8|||<|0.001|2-Sided|95.0|-2.9|6.5|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 23F|
1594464|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|2-Sided|95.0|-1.0|1.9|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 19F|
1597185|NCT02915835|2935805|Superiority|||||||1|||||||Fisher Exact||||
1594465|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.3|||<|0.001|2-Sided|95.0|-1.9|2.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 19A|
1594466|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.2|||<|0.001|2-Sided|95.0|-2.1|4.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 18C|
1594467|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|2.0|||<|0.001|2-Sided|95.0|-0.2|4.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 14|
1594468|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|1.3|||<|0.001|2-Sided|95.0|-1.9|4.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 9V|
1594469|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|0.7|||<|0.001|2-Sided|95.0|-1.1|2.7|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 7F|
1594470|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.8|||<|0.001|2-Sided|95.0|-5.7|4.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 6B|
1594471|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-5.6|||<|0.001|2-Sided|95.0|-10.0|-1.6|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 6A|
1594472|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.5|||<|0.001|2-Sided|95.0|-3.9|2.8|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 5|
1594473|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|3.0|||<|0.001|2-Sided|95.0|0.0|6.4|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 4|
1594474|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|24.2|||<|0.001|2-Sided|95.0|18.7|30.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar|Type 3|
1594475|NCT02987972|2931796|Non-Inferiority|Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.|Difference in Percentages|-0.1|||<|0.001|2-Sided|95.0|-3.3|3.0|||Miettinen and Nurminen||Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™|Type 1|
1594476|NCT02987205|2931813|Non-Inferiority|If the upper bound of this 95% CI was less than the prespecified non-inferiority limit of 0.50, the Test product would be claimed to be non-inferior to the Comparator product.||||||0.013||||||Wilcoxon matched-pairs signed rank test|Wilcoxon (Mann-Whitney)||||
1594477|NCT02986958|2931821|Other|We used generalized estimating equations with an exchangeable correlation structure to assess the direction, magnitude, and statistical significance of between-group differences. Regression models included treatment assignment and patient-level covariates (patient age, gender, and MMSE score) that were postulated as affecting communication outcomes. Statistical tests were 2-sided with a significance level of 0.05. Analyses were performed in SAS statistical software, version 9.4 (SAS, Cary, NC).|Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.08||0.046|2-Sided||||||t-test, 2 sided||||
1594478|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.06|||||2-Sided|95.0|0.83|1.35||||||Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)|
1594479|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|27.73|||||2-Sided|95.0|20.1|38.26||||||Serogroup Y-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594480|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|26.94|||||2-Sided|95.0|19.09|38.02||||||Serogroup Y-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)|
1594803|NCT02981342|2932108|Superiority||LSMean Difference|-6.95|Standard Error of the Mean|7.05||0.33|2-Sided|95.0|-21.17|7.27|||Mixed Models Analysis|||Functional Scales: Emotional functioning|
1610818|NCT02540265|2959056|Other||Effect Size|1.01|||||2-Sided||||||||||
1594481|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|28.52|||||2-Sided|95.0|20.23|40.2||||||Serogroup Y-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)|
1594482|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.03|||||2-Sided|95.0|0.69|1.54||||||Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)|
1594483|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.69|||||2-Sided|95.0|5.59|16.79||||||Serogroup Y-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594484|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.55|||||2-Sided|95.0|5.31|17.19||||||Serogroup Y-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)|
1594485|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|9.82|||||2-Sided|95.0|5.47|17.64||||||Serogroup Y-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)|
1594486|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.9|||||2-Sided|95.0|0.61|1.33||||||Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)|
1594487|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.48|||||2-Sided|95.0|1.48|4.14||||||Serogroup Y-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594488|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.62|||||2-Sided|95.0|1.51|4.54||||||Serogroup Y-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)|
1594489|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.35|||||2-Sided|95.0|1.36|4.07||||||Serogroup Y-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)|
1594490|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.74|||||2-Sided|95.0|0.58|0.94||||||Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)|
1594491|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|29.24|||||2-Sided|95.0|21.09|40.52||||||Serogroup W-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594492|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|34.06|||||2-Sided|95.0|24.06|48.23||||||Serogroup W-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)|
1594493|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|25.21|||||2-Sided|95.0|17.83|35.65||||||Serogroup W-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)|
1594494|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.78|||||2-Sided|95.0|0.54|1.14||||||Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)|
1594495|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.94|||||2-Sided|95.0|4.72|13.35||||||Serogroup W-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594496|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|8.99|||||2-Sided|95.0|5.16|15.66||||||Serogroup W-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)|
1594497|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.04|||||2-Sided|95.0|4.05|12.22||||||Serogroup W-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)|
1594804|NCT02981342|2932108|Superiority||LSMean Difference|-4.26|Standard Error of the Mean|6.91||0.541|2-Sided|95.0|-18.2|9.68|||Mixed Models Analysis|||Functional Scales: Emotional functioning|
1597186|NCT02915835|2935806|Superiority|||||||0.61|||||||Fisher Exact||||
1594498|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.76|||||2-Sided|95.0|0.53|1.1||||||Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)|
1594499|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.14|||||2-Sided|95.0|1.33|3.44||||||Serogroup W-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594500|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.46|||||2-Sided|95.0|1.48|4.08||||||Serogroup W-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)|
1594501|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.88|||||2-Sided|95.0|1.13|3.11||||||Serogroup W-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)|
1594502|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.1|||||2-Sided|95.0|0.86|1.4||||||Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)|
1594503|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|18.57|||||2-Sided|95.0|13.4|25.73||||||Serogroup C-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594504|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|17.72|||||2-Sided|95.0|12.5|25.12||||||Serogroup C-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)|
1594505|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|19.43|||||2-Sided|95.0|13.73|27.51||||||Serogroup C-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)|
1594506|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.02|||||2-Sided|95.0|0.67|1.56||||||Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)|
1594507|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.59|||||2-Sided|95.0|7.7|24.0||||||Serogroup C-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594508|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.42|||||2-Sided|95.0|7.31|24.66||||||Serogroup C-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)|
1594509|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|13.75|||||2-Sided|95.0|7.51|25.19||||||Serogroup C-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)|
1594510|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.61|||||2-Sided|95.0|1.07|2.4||||||Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)|
1594511|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.72|||||2-Sided|95.0|1.6|4.64||||||Serogroup C-Vaccine comparison at day 4 - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594512|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|2.14|||||2-Sided|95.0|1.21|3.77||||||Serogroup C-Vaccine comparison at day 4 (Menactra-Menveo vs. Naive)|
1594513|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|between group GMT ratios|3.43|||||2-Sided|95.0|1.95|6.04||||||Serogroup C-Vaccine comparison at day 4 (Menveo-Menveo vs. Naive)|
1594514|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.89|||||2-Sided|95.0|0.72|1.1||||||Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Menactra-Menveo)|
1594805|NCT02981342|2932108|Superiority||LSMean Difference|0.01|Standard Error of the Mean|9.62||0.999|2-Sided|95.0|-19.4|19.42|||Mixed Models Analysis|||Functional Scales: Role functioning.|
1597187|NCT02915835|2935807|Superiority|||||||0.7|||||||ANCOVA||||
1594515|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|6.94|||||2-Sided|95.0|5.23|9.21||||||Serogroup A-Vaccine comparison at day 29 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594516|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|7.37|||||2-Sided|95.0|5.44|9.98||||||Serogroup A-Vaccine comparison at day 29 (Menactra-Menveo vs. Naive)|
1594517|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|6.54|||||2-Sided|95.0|4.84|8.85||||||Serogroup A-Vaccine comparison at day 29 (Menveo-Menveo vs. Naive)|
1594518|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.27|||||2-Sided|95.0|0.84|1.91||||||Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Menactra-Menveo)|
1594519|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|4.62|||||2-Sided|95.0|2.62|8.15||||||Serogroup A-Vaccine comparison at day 6 (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594520|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|4.1|||||2-Sided|95.0|2.24|7.5||||||Serogroup A-Vaccine comparison at day 6 (Menactra-Menveo vs. Naive)|
1594521|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|5.19|||||2-Sided|95.0|2.84|9.47||||||Serogroup A-Vaccine comparison at day 6 (Menveo-Menveo vs. Naive)|
1594522|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|0.94|||||2-Sided|95.0|0.76|1.17||||||Serogroup A-Vaccine comparison at day 4 (Menveo-Menveo vs. Menactra-Menveo)|
1594523|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.29|||||2-Sided|95.0|0.97|1.72||||||Serogroup A-Vaccine comparison at day 4(Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594524|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.34|||||2-Sided|95.0|0.98|1.82||||||Serogroup A-Vaccine comparison at day 4(Menactra-Menveo vs. Naive)|
1594525|NCT02986854|2931823|Other|GMTs ratio and 95% CI, at each time point against each serogroups A, C, W and Y strains was obtained by exponentiating the mean between-group differences in log-transformed titers and the corresponding 95% CIs at each of the timepoints specified|Between group GMT ratios|1.26|||||2-Sided|95.0|0.93|1.7||||||Serogroup A-Vaccine comparison at day 4(Menveo-Menveo vs. Naive)|
1594526|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|-8.19|||||2-Sided|95.0|-19.61|3.45||||||Serogroup Y- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)|
1594527|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|43.91|||||2-Sided|95.0|30.79|52.37||||||Serogroup Y- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594528|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|48.05|||||2-Sided|95.0|33.89|58.34||||||Serogroup Y- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)|
1594529|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|39.86|||||2-Sided|95.0|25.76|50.29||||||Serogroup Y- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)|
1594530|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|3.37|||||2-Sided|95.0|-2.48|9.54||||||Serogroup Y- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)|
1594531|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|6.09|||||2-Sided|95.0|-1.41|9.55||||||Serogroup Y- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594532|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|4.38|||||2-Sided|95.0|-3.15|9.24||||||Serogroup Y- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)|
1594533|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|7.75|||||2-Sided|95.0|0.15|13.36||||||Serogroup Y- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)|
1594534|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|1.06|||||2-Sided|95.0|-10.51|12.6||||||Serogroup W- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)|
1594535|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|38.46|||||2-Sided|95.0|24.8|47.56||||||Serogroup W- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594536|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|37.92|||||2-Sided|95.0|23.23|48.95||||||Serogroup W- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)|
1594537|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|38.98|||||2-Sided|95.0|24.35|49.88||||||Serogroup W- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)|
1594538|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|-7.37|||||2-Sided|95.0|-13.89|-1.8||||||Serogroup W- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)|
1594539|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|0.13|||||2-Sided|95.0|-10.7|5.66||||||Serogroup W- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594540|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|3.89|||||2-Sided|95.0|-7.4|11.6||||||Serogroup W- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)|
1594541|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|-3.47|||||2-Sided|95.0|-14.28|2.31||||||Serogroup W- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)|
1594542|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|3.19|||||2-Sided|95.0|-8.44|14.73||||||Serogroup C- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)|
1594543|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|38.46|||||2-Sided|95.0|24.79|47.57||||||Serogroup C- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594544|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|36.84|||||2-Sided|95.0|22.14|47.9||||||Serogroup C- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)|
1594545|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|40.03|||||2-Sided|95.0|25.37|50.92||||||Serogroup C- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)|
1594546|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|-5.96|||||2-Sided|95.0|-12.25|-0.57||||||Serogroup C- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)|
1594547|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|-0.54|||||2-Sided|95.0|-11.35|4.9||||||Serogroup C- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594548|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|2.51|||||2-Sided|95.0|-8.7|9.98||||||Serogroup C- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)|
1594549|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|-3.45|||||2-Sided|95.0|-14.26|2.35||||||Serogroup C- Day 4-Total seroresponse- (Menveo-Menveo vs. Naive)|
1594550|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|7.88|||||2-Sided|95.0|-3.25|18.81||||||Serogroup A- Day 6-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)|
1594551|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|30.89|||||2-Sided|95.0|19.42|37.97||||||Serogroup A- Day 6-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594552|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|26.88|||||2-Sided|95.0|14.67|36.13||||||Serogroup A- Day 6-Total seroresponse - (Menactra-Menveo vs. Naive)|
1594553|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|34.76|||||2-Sided|95.0|22.38|44.07||||||Serogroup A- Day 6-Total seroresponse- (Menveo-Menveo vs. Naive)|
1594554|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|-0.79|||||2-Sided|95.0|-4.98|3.01||||||Serogroup A- Day 4-Total seroresponse - (Menveo-Menveo vs. Menactra-Menveo)|
1594555|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|1.77|||||2-Sided|95.0|-5.68|4.09||||||Serogroup A- Day 4-Total seroresponse - (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594556|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|2.17|||||2-Sided|95.0|-5.32|6.21||||||Serogroup A- Day 4-Total seroresponse - (Menactra-Menveo vs. Naive)|
1594557|NCT02986854|2931824|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Differences in percentage|1.39|||||2-Sided|95.0|-6.08|4.94||||||Serogroup A- Day 4- Total seroresponse (Menveo-Menveo vs. Naive)|
1594928|NCT02977507|2932348|Other|||||||0.002|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.|
1594558|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|1.42|||||2-Sided|95.0|0.1|3.6||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)|
1594559|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|34.78|||||2-Sided|95.0|25.78|44.93||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594560|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|34.06|||||2-Sided|95.0|24.94|44.28||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)|
1594561|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|35.48|||||2-Sided|95.0|26.5|45.62||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)|
1594562|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|0.69|||||2-Sided|95.0|-8.6|10.04||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)|
1594563|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|48.53|||||2-Sided|95.0|33.04|61.31||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594564|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|48.18|||||2-Sided|95.0|31.87|61.79||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)|
1594565|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|48.87|||||2-Sided|95.0|32.64|62.38||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)|
1594566|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|0.03|||||2-Sided|95.0|-11.35|11.39||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)|
1594567|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|18.31|||||2-Sided|95.0|3.83|29.39||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594568|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|18.3|||||2-Sided|95.0|2.83|31.06||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)|
1594569|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|18.33|||||2-Sided|95.0|2.92|30.99||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)|
1594570|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|4.15|||||2-Sided|95.0|-3.8|12.04||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)|
1594571|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|19.77|||||2-Sided|95.0|10.09|27.43||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594572|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|17.67|||||2-Sided|95.0|7.34|26.43||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)|
1594573|NCT02986854|2931825|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|21.82|||||2-Sided|95.0|11.44|30.6||||||Serogroup Y- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)|
1594574|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|0.0|||||2-Sided|95.0|-1.31|1.35||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)|
1594575|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|19.57|||||2-Sided|95.0|12.75|28.83||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594576|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|19.57|||||2-Sided|95.0|12.74|28.83||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)|
1594577|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|19.57|||||2-Sided|95.0|12.74|28.83||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)|
1594578|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|-3.1|||||2-Sided|95.0|-10.2|3.89||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)|
1594929|NCT02977507|2932349|Other|||||||0.0005|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.|
1594579|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|40.56|||||2-Sided|95.0|25.91|55.15||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594580|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|42.14|||||2-Sided|95.0|27.08|56.98||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)|
1594581|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|39.04|||||2-Sided|95.0|23.76|54.07||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)|
1594582|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|-8.06|||||2-Sided|95.0|-18.34|2.38||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)|
1594583|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|18.53|||||2-Sided|95.0|4.14|33.37||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594584|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|22.64|||||2-Sided|95.0|7.3|38.16||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)|
1594585|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|14.58|||||2-Sided|95.0|-0.98|30.38||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)|
1594586|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|-0.57|||||2-Sided|95.0|-8.32|7.2||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)|
1594587|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|17.64|||||2-Sided|95.0|6.85|28.28||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594588|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|17.92|||||2-Sided|95.0|6.39|29.25||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)|
1594589|NCT02986854|2931826|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|17.36|||||2-Sided|95.0|5.85|28.67||||||Serogroup W- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)|
1594590|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|0.01|||||2-Sided|95.0|-1.6|1.67||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)|
1594591|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|29.76|||||2-Sided|95.0|21.35|39.73||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594592|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|29.75|||||2-Sided|95.0|21.32|39.74||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)|
1594593|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|29.76|||||2-Sided|95.0|21.34|39.75||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)|
1594594|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|0.77|||||2-Sided|95.0|-8.3|9.92||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)|
1594595|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|49.87|||||2-Sided|95.0|34.42|62.6||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594596|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|49.48|||||2-Sided|95.0|33.21|63.01||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)|
1594597|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|50.25|||||2-Sided|95.0|34.09|63.67||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)|
1594598|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|9.24|||||2-Sided|95.0|-2.45|20.68||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)|
1594599|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|20.48|||||2-Sided|95.0|5.32|33.08||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594930|NCT02977507|2932349|Other|||||||0.041|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.|
1594600|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|15.76|||||2-Sided|95.0|-0.44|29.86||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)|
1594601|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|25.0|||||2-Sided|95.0|8.82|38.9||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)|
1594602|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|9.14|||||2-Sided|95.0|1.01|17.16||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)|
1594603|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|25.5|||||2-Sided|95.0|15.79|33.21||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594604|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|20.87|||||2-Sided|95.0|10.48|29.69||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)|
1594605|NCT02986854|2931827|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|30.02|||||2-Sided|95.0|19.55|38.83||||||Serogroup C- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)|
1594606|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|0.76|||||2-Sided|95.0|-1.81|3.52||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)|
1594607|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|31.24|||||2-Sided|95.0|22.39|41.38||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594608|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|30.85|||||2-Sided|95.0|21.85|41.08||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)|
1594609|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|31.61|||||2-Sided|95.0|22.68|41.79||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)|
1594610|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|4.46|||||2-Sided|95.0|-7.04|15.83||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)|
1594611|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|39.16|||||2-Sided|95.0|27.61|46.33||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594612|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|36.88|||||2-Sided|95.0|24.39|46.34||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)|
1594613|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|41.34|||||2-Sided|95.0|28.85|50.63||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)|
1594614|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|-0.36|||||2-Sided|95.0|-7.27|6.43||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)|
1594615|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|6.43|||||2-Sided|95.0|-2.66|10.9||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594616|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|6.61|||||2-Sided|95.0|-2.71|13.01||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)|
1594617|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|6.25|||||2-Sided|95.0|-3.04|12.44||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)|
1594618|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|-1.27|||||2-Sided|95.0|-6.1|3.49||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)|
1594619|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|7.86|||||2-Sided|95.0|2.87|10.78||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594620|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|8.5|||||2-Sided|95.0|3.28|12.74||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)|
1595056|NCT02969018|2932743|Other||Least Squares Mean Difference|-7.99|Standard Error of the Mean|1.502|<|0.0001|2-Sided|90.0|-10.48|-5.51|||Mixed Models Analysis||||
1594621|NCT02986854|2931828|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|7.23|||||2-Sided|95.0|2.08|11.23||||||Serogroup A- hSBA titer ≥16-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)|
1594622|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|0.36|||||2-Sided|95.0|-0.96|1.99||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)|
1594623|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|22.41|||||2-Sided|95.0|15.08|31.9||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594624|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|22.22|||||2-Sided|95.0|14.86|31.74||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)|
1594625|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|22.58|||||2-Sided|95.0|15.26|32.08||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)|
1594626|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|-2.34|||||2-Sided|95.0|-10.41|5.73||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)|
1594627|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|41.21|||||2-Sided|95.0|26.12|55.55||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594628|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|42.4|||||2-Sided|95.0|26.71|57.17||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)|
1594629|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|40.06|||||2-Sided|95.0|24.26|54.95||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)|
1594630|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|-0.55|||||2-Sided|95.0|-12.11|11.03||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)|
1594631|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|22.18|||||2-Sided|95.0|6.89|35.38||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594632|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|22.46|||||2-Sided|95.0|6.05|37.0||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)|
1594633|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|21.91|||||2-Sided|95.0|5.57|36.37||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)|
1594634|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|7.03|||||2-Sided|95.0|-1.2|15.17||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)|
1594635|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|18.27|||||2-Sided|95.0|7.44|27.92||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594636|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|14.72|||||2-Sided|95.0|3.15|25.29||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)|
1594637|NCT02986854|2931829|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|21.75|||||2-Sided|95.0|10.19|32.25||||||Serogroup Y- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)|
1594638|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|0.0|||||2-Sided|95.0|-1.31|1.35||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)|
1594639|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|15.22|||||2-Sided|95.0|9.28|23.94||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594640|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|15.22|||||2-Sided|95.0|9.28|23.95||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)|
1594641|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|15.22|||||2-Sided|95.0|9.28|23.95||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)|
1595057|NCT02969018|2932743|Other||Least Squares Mean Difference|-9.0|Standard Error of the Mean|1.47|<|0.0001|2-Sided|90.0|-11.43|-6.57|||Mixed Models Analysis||||
1594642|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|-4.02|||||2-Sided|95.0|-9.45|0.74||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)|
1594643|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|32.17|||||2-Sided|95.0|19.3|47.13||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594644|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|34.22|||||2-Sided|95.0|21.29|49.2||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)|
1594645|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|30.2|||||2-Sided|95.0|16.78|45.45||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)|
1594646|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|-0.66|||||2-Sided|95.0|-9.67|8.4||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)|
1594647|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|19.77|||||2-Sided|95.0|6.53|34.58||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594648|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|20.11|||||2-Sided|95.0|5.88|35.5||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)|
1594649|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|19.44|||||2-Sided|95.0|5.25|34.83||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)|
1594650|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|-1.52|||||2-Sided|95.0|-8.51|5.5||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)|
1594651|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|14.89|||||2-Sided|95.0|4.91|25.62||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594652|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|15.66|||||2-Sided|95.0|5.0|26.89||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)|
1594653|NCT02986854|2931830|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|14.14|||||2-Sided|95.0|3.46|25.39||||||Serogroup W- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)|
1594654|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|0.36|||||2-Sided|95.0|-0.96|1.99||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)|
1594655|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|12.73|||||2-Sided|95.0|7.34|21.05||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594656|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|12.55|||||2-Sided|95.0|7.1|20.89||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)|
1594657|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|12.9|||||2-Sided|95.0|7.53|21.22||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)|
1594658|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|-4.5|||||2-Sided|95.0|-11.84|2.69||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)|
1594659|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|46.61|||||2-Sided|95.0|31.52|60.59||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594660|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|48.9|||||2-Sided|95.0|33.45|63.13||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)|
1594661|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|44.4|||||2-Sided|95.0|28.65|58.93||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)|
1594662|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|10.69|||||2-Sided|95.0|-0.42|21.6||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)|
1594806|NCT02981342|2932108|Superiority||LSMean Difference|0.96|Standard Error of the Mean|9.54||0.921|2-Sided|95.0|-18.29|20.21|||Mixed Models Analysis|||Functional Scales: Role functioning|
1594663|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|21.85|||||2-Sided|95.0|6.73|36.11||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594664|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|16.39|||||2-Sided|95.0|0.04|31.9||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)|
1594665|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|27.08|||||2-Sided|95.0|11.04|42.14||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)|
1594666|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|7.37|||||2-Sided|95.0|-0.76|15.42||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)|
1594667|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|24.14|||||2-Sided|95.0|13.28|33.86||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594668|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|20.4|||||2-Sided|95.0|8.78|31.03||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)|
1594669|NCT02986854|2931831|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|27.78|||||2-Sided|95.0|16.23|38.27||||||Serogroup C- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)|
1594670|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|-0.32|||||2-Sided|95.0|-2.56|1.86||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Menactra-Menveo)|
1594671|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|27.81|||||2-Sided|95.0|19.5|37.76||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594672|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|27.97|||||2-Sided|95.0|19.6|37.95||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menactra-Menveo vs. Naive)|
1594673|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|27.65|||||2-Sided|95.0|19.25|37.65||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 29- (Menveo-Menveo vs. Naive)|
1594674|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|6.28|||||2-Sided|95.0|-5.31|17.71||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Menactra-Menveo)|
1594675|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|41.26|||||2-Sided|95.0|28.15|49.72||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594676|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|38.05|||||2-Sided|95.0|23.93|48.58||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menactra-Menveo vs. Naive)|
1594677|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|44.33|||||2-Sided|95.0|30.25|54.6||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 6- (Menveo-Menveo vs. Naive)|
1594678|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|-1.93|||||2-Sided|95.0|-9.84|5.82||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Menactra-Menveo)|
1594679|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|7.89|||||2-Sided|95.0|-2.34|13.48||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Pooled Menveo-Menveo and Menactra-Menveo vs. Naive)|
1594680|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|8.88|||||2-Sided|95.0|-1.77|16.52||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menactra-Menveo vs. Naive)|
1594681|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|6.94|||||2-Sided|95.0|-3.57|14.15||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 4- (Menveo-Menveo vs. Naive)|
1594682|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method.|Between group differences in percentage|-2.44|||||2-Sided|95.0|-8.17|3.24||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Menactra-Menveo)|
1594683|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method.|Between group differences in percentage|9.36|||||2-Sided|95.0|2.72|13.58||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Pooled Menactra-Menveo vs. Naive)|
1594923|NCT02977507|2932343|Other|||||||0.0007|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.|
1594684|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method.|Between group differences in percentage|10.59|||||2-Sided|95.0|3.54|16.14||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menactra-Menveo vs. Naive)|
1594685|NCT02986854|2931832|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Between groups differences in percentage|8.16|||||2-Sided|95.0|1.23|13.41||||||Serogroup A- hSBA titer ≥8-Vaccine comparison at Day 1- (Menveo-Menveo vs. Naive)|
1594686|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|2.58|||||2-Sided|95.0|-0.86|6.3||||||Serogroup Y- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)|
1594687|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|43.98|||||2-Sided|95.0|33.92|54.14||||||Serogroup Y-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594688|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|42.67|||||2-Sided|95.0|32.34|53.04||||||Serogroup Y-day 29-Total seroresponse (Menactra-Menveo vs. Naive)|
1594689|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|45.25|||||2-Sided|95.0|35.11|55.47||||||Serogroup Y-day 29-Total seroresponse (Menveo-Menveo vs. Naive)|
1594690|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|2.61|||||2-Sided|95.0|-1.17|6.62||||||Serogroup W-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)|
1594691|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|58.69|||||2-Sided|95.0|48.32|67.94||||||Serogroup W-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594692|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|57.37|||||2-Sided|95.0|46.71|66.88||||||Serogroup W-day 29-Total seroresponse (Menactra-Menveo vs. Naive)|
1594693|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|59.98|||||2-Sided|95.0|49.49|69.32||||||Serogroup W-day 29-Total seroresponse (Menveo-Menveo vs. Naive)|
1594694|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|-0.59|||||2-Sided|95.0|-4.12|2.92||||||Serogroup C-DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)|
1594695|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|38.79|||||2-Sided|95.0|29.03|49.06||||||Serogroup C-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594696|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|39.08|||||2-Sided|95.0|29.16|49.46||||||Serogroup C-day 29-Total seroresponse (Menactra-Menveo vs. Naive)|
1594697|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|38.5|||||2-Sided|95.0|28.54|48.9||||||Serogroup C-day 29-Total seroresponse (Menveo-Menveo vs. Naive)|
1594698|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method.|Difference in percentages|0.09|||||2-Sided|95.0|-3.15|3.36||||||Serogroup A- DAY 29 : Total seroresponse (Menveo-Menveo vs. Menactra-Menveo)|
1594699|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|30.91|||||2-Sided|95.0|21.89|41.12||||||Serogroup A-day 29-Total seroresponse (Pooled Menveo-Menveo and Menactra-Menveo vs. Naïve)|
1594700|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|30.86|||||2-Sided|95.0|21.66|41.17||||||Serogroup A-day 29-Total seroresponse (Menactra-Menveo vs. Naive)|
1594701|NCT02986854|2931838|Other|Differences in percentages and associated 95% CIs between study groups were calculated using the Miettinen & Nurminen score method|Difference in percentages|30.95|||||2-Sided|95.0|21.76|41.25||||||Serogroup A-day 29-Total seroresponse (Menveo-Menveo vs. Naive)|
1594702|NCT02986282|2931873|Other||Median Difference (Final Values)|-0.0249837|||<|0.05|2-Sided|95.0|-0.039992|-0.0100226|||Wilcoxon (Mann-Whitney)||||
1594703|NCT02986282|2931874|Other||Median Difference (Final Values)|-0.0600326|||<|0.05|2-Sided|95.0|-0.0799661|-0.0449876|||Wilcoxon (Mann-Whitney)|||It was calculated that the study sample size of 79 subjects would be needed to detect a difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a two-tailed α of 0.05 and a (1-β) of 0.90. Our initial estimate of sample size of 115 patients incorporated an assumption of dropout. Intra-observer variability was calculated using intra-class correlation coefficient.|
1594704|NCT02986139|2931877|Superiority||LS Mean Difference|-4.0||||0.048|2-Sided|95.0|-8.0|0.0|||Mixed effects analysis of variance model|||A mixed effects analysis of variance model was used to assess injection site pain with the new formulation of etanercept as the test treatment and the commercial formulation of etanercept as the reference treatment. Treatment, study period, sequence, and disease indication were evaluated as fixed effect covariates, and subject within sequence was included as a random effect.|
1594749|NCT02984709|2932008|Superiority||Estimated Mean Difference|-2.494||||0.511|2-Sided|95.0|-10.11|5.13||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||Child-reported family conflict|
1594924|NCT02977507|2932343|Other|||||||0.003|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.|
1594705|NCT02985684|2931909|Other|Acceptable performance: favorably exclude PG=0.76 with 95% confidence. Expected 6-month clinical success proportion = 0.88. Acceptable performance margin = 0.12. PG = 0.88 - 0.12 = 0.76.|Binomial proportion|0.9|||<|0.0001|1-Sided|95.0|0.843|||A priori 1-sided alpha = 0.05. If test of primary outcome 1 rejects H0, then test at 1-sided alpha = 0.05; otherwise no testing of this primary outcome and failure to reject null hypothesis.|Binomial test (exact)||Exact 1-sided confidence interval lower bound from Clopper-Pearson method.|"Test null hypothesis of equal or lesser proportion with 6-month clinical success compared to a performance goal (PG).~H0: P ≤ 0.76 vs H1: P > 0.76, where P is the true proportion of subjects with 6-month clinical success and 0.76 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=112 subjects provide 95% power to exclude PG with 95% confidence if P=0.88 under H1."|
1594706|NCT02985684|2931910|Other|Acceptable performance: favorably exclude PG=0.88 with 95% confidence. Expected 6-month closure success proportion = 0.98. Acceptable performance margin = 0.10. PG = 0.98 - 0.10 = 0.88.|Binomial proportion|1.0|||<|0.0001|1-Sided|95.0|0.974|||A priori 1-sided alpha = 0.05. If test rejects H0, then test primary outcome 2 (clinical success) at 1-sided alpha = 0.05; otherwise testing stops with failure to reject both primary outcome null hypotheses.|Binomial test (exact)||Exact 1-sided confidence interval lower bound from Clopper-Pearson method.|"Test null hypothesis of equal or lesser proportion with 6-month closure success compared to a performance goal (PG).~H0: P ≤ 0.88 vs H1: P > 0.88, where P is the true proportion of subjects with 6-month closure success and 0.88 is the PG derived from clinical study outcomes for devices indicated for ASD closure.~N=103 subjects provide ≥95% power to exclude PG with 95% confidence if P=0.98 under H1."|
1594707|NCT02984982|2931959|Superiority||LS mean difference|-1.64|Standard Error of the Mean|1.36||0.2279|2-Sided|95.0|-4.32|1.04||Threshold for significance at 0.05 level.|ANCOVA||Standard of Care vs Alirocumab|Analysis was performed using ANCOVA model which included fixed categorical effects of treatment arm and randomization strata, as well as the continuous fixed covariate of baseline normalized TAV.|
1594708|NCT02984943|2931960|Other||||||||||||||||||Descriptive statistics only were used
1594709|NCT02984943|2931961|Other||||||||||||||||||Descriptive statistics only were used
1594710|NCT02984943|2931962|Other||||||||||||||||||Descriptive statistics only were used
1594711|NCT02984943|2931963|Other||||||||||||||||||Descriptive statistics only were used
1594712|NCT02984943|2931965|Other||||||||||||||||||Descriptive statistics only were used
1594713|NCT02984943|2931966|Other||||||||||||||||||Descriptive statistics only were used
1594714|NCT02984943|2931967|Other||||||||||||||||||Descriptive statistics only were used
1594715|NCT02984943|2931969|Other||||||||||||||||||Descriptive statistics only were used
1594716|NCT02984943|2931970|Other||||||||||||||||||Descriptive statistics only were used
1594717|NCT02984943|2931971|Other||||||||||||||||||Descriptive statistics only were used
1594718|NCT02984943|2931972|Other||||||||||||||||||Descriptive statistics only were used
1594719|NCT02984943|2931973|Other||||||||||||||||||Descriptive statistics only were used
1594720|NCT02984943|2931974|Other||||||||||||||||||Descriptive statistics only were used
1594721|NCT02984943|2931975|Other||||||||||||||||||Descriptive statistics only were used
1594722|NCT02984943|2931976|Other|||||||0.08|||||||Skillings-Mack test||||
1594723|NCT02984943|2931977|Other|||||||0.08|||||||Skillings-Mack test||||
1594724|NCT02984943|2931978|Other|||||||0.0183|||||||Skillings-Mack test||||
1594725|NCT02984943|2931979|Other|||||||0.0183|||||||Skillings-Mack test||||
1594726|NCT02984943|2931980|Other|||||||0.0068|||||||Skillings-Mack test||||
1594727|NCT02984943|2931981|Other|||||||0.0068|||||||Skillings-Mack test||||
1594728|NCT02984943|2931982|Other|||||||0.9|||||||Skillings-Mack test||||
1594729|NCT02984943|2931983|Other|||||||0.9|||||||Skillings-Mack test||||
1594730|NCT02984943|2931984|Other|||||||0.0012|||||||Skillings-Mack test||||
1594731|NCT02984943|2931985|Other|||||||0.0012|||||||Skillings-Mack test||||
1594732|NCT02984943|2931986|Other|||||||0.36|||||||Skillings-Mack test||||
1594733|NCT02984943|2931987|Other|||||||0.36|||||||Skillings-Mack test||||
1594734|NCT02984943|2931988|Other|||||||0.1496|||||||Skillings-Mack test||||
1594735|NCT02984943|2931989|Other|||||||0.1496|||||||Skillings-Mack test||||
1594736|NCT02984943|2931990|Other|||||||0.0608|||||||Skillings-Mack test||||
1594737|NCT02984943|2931991|Other|||||||0.0608|||||||Skillings-Mack test||||
1594738|NCT02984943|2931992|Other|||||||0.2938|||||||Skillings-Mack test||||
1594739|NCT02984943|2931993|Other|||||||0.2938|||||||Skillings-Mack test||||
1594740|NCT02984943|2931994|Other|||||||0.004|||||||Skillings-Mack test||||
1594741|NCT02984943|2931995|Other|||||||0.004|||||||Skillings-Mack test||||
1594742|NCT02984943|2931996|Other|||||||0.02|||||||Skillings-Mack test||||
1594743|NCT02984943|2931997|Other|||||||0.02|||||||Skillings-Mack test||||
1594744|NCT02984943|2931998|Other|||||||0.1|||||||Skillings-Mack test||||
1594745|NCT02984943|2931999|Other|||||||0.1|||||||Skillings-Mack test||||
1594746|NCT02984709|2932006|Superiority||Estimated Mean Difference|2.996||||0.603|2-Sided|95.0|-8.57|14.56||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression||||
1594747|NCT02984709|2932007|Superiority||Estimated Mean Difference|0.396||||0.873|2-Sided|95.0|-4.57|5.36||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression||||
1594748|NCT02984709|2932008|Superiority||Estimated Mean Difference|-3.354||||0.19|2-Sided|95.0|-8.44|1.73||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression|||Parent-reported family conflict|
1594802|NCT02981342|2932108|Superiority||LSMean Difference|-2.04|Standard Error of the Mean|6.29||0.747|2-Sided|95.0|-14.74|10.66|||Mixed Models Analysis|||Functional Scales: Cognitive Functioning|
1594750|NCT02984709|2932009|Superiority||Estimated Mean Difference|-0.587||||0.206|2-Sided|95.0|-1.52|0.34||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression||||
1594751|NCT02984709|2932010|Superiority||Estimated Mean Difference|-1.137||||0.581|2-Sided|95.0|-5.27|2.99||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression||||
1594752|NCT02984709|2932011|Superiority||Estimated Mean Difference|-0.17||||0.593|2-Sided|95.0|-0.81|0.47||The following a priori selected covariates were adjusted in each analysis: age, sex, race/ethnicity, income, baseline depressive symptoms, pump use, and baseline measurement for each outcome.|Multiple linear regression||||
1594753|NCT02983877|2932038|Superiority|||||||0.89|||||||ANOVA|2 degrees of freedom|||
1594754|NCT02983877|2932039|Superiority||||||<|0.001|||||||Friedman test|3 degrees of freedom|||
1594755|NCT02983877|2932040|Superiority||||||<|0.001|||||||ANOVA|3 degrees of freedom|||
1594756|NCT02983877|2932041|Superiority||||||<|0.001|||||||Friedman test|3 degrees of freedom|||
1594757|NCT02983305|2932057|Equivalence|Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.79||||||P < .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Comparison between study arms of the change in the gait speed detected between baseline and intervention.|
1594758|NCT02983305|2932057|Equivalence|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.27||||||P < .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of gait speed under intervention conditions.|
1594759|NCT02983305|2932057|Equivalence|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.||||||0.38||||||P < .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of gait speed at baseline.|
1594760|NCT02983305|2932058|Equivalence|Mann-Whitney U test was used to test non-equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.003||||||P < .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Comparison between study arms of the change in the visual field area (average of both eyes) detected between baseline and intervention.|
1594761|NCT02983305|2932058|Equivalence|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms under intervention conditions.||||||0.0001||||||P < .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of visual field area under intervention conditions.|
1594762|NCT02983305|2932058|Equivalence|Mann-Whitney U test was used to test equivalence of this outcome measure for the two study arms at baseline.||||||0.0001||||||P < .05 was considered a priori to be statistically significant.|Wilcoxon (Mann-Whitney)|||Test of equivalence of visual field area at baseline.|
1594763|NCT02982187|2932084|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1594764|NCT02982187|2932084|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1594765|NCT02982187|2932085|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1594766|NCT02982187|2932085|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1594767|NCT02982187|2932089|Superiority||||||<|0.001|||||||Wilcoxon signed rank test|This method of analysis does not take sequence of treatment option into account||Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|
1594768|NCT02982187|2932089|Superiority||||||<|0.001|||||||Wilcoxon signed rank test|This method of analysis does not take sequence of treatment option into account||Sub study 1:DISKUS + HandiHaler vs ELLIPTA|
1594769|NCT02982187|2932090|Superiority||Odds Ratio (OR)|1.732||||0.5|2-Sided|95.0|0.397||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|
1594770|NCT02982187|2932090|Superiority|||||||||||||||||Sub study 1: DISKUS + HandiHaler vs ELLIPTA|These statistics were only presented when the model successfully converged. A stratified exact logistic model was used with participant included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.
1594771|NCT02982187|2932091|Superiority||Odds Ratio (OR)|6.357||||0.003|2-Sided|95.0|2.219||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|
1594772|NCT02982187|2932091|Superiority||Odds Ratio (OR)|3.237||||0.067|2-Sided|95.0|1.124||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|
1594773|NCT02982187|2932092|Superiority||Odds Ratio (OR)|17.974|||<|0.001|2-Sided|95.0|7.239||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|
1594774|NCT02982187|2932092|Superiority||Odds Ratio (OR)|24.539|||<|0.001|2-Sided|95.0|9.268||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|
1594925|NCT02977507|2932347|Other|||||||0.001|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.|
1594775|NCT02982187|2932093|Superiority||Odds Ratio (OR)|1.732||||0.5|2-Sided|95.0|0.397||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|
1594776|NCT02982187|2932093|Superiority||Odds Ratio (OR)|2.0||||0.4|2-Sided|95.0|0.459||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|
1594777|NCT02982187|2932094|Superiority||Odds Ratio (OR)|3.855||||0.026|2-Sided|95.0|1.394||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|
1594778|NCT02982187|2932094|Superiority||Odds Ratio (OR)|4.248||||0.029|2-Sided|95.0|1.416||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1:DISKUS + HandiHaler vs ELLIPTA|
1594779|NCT02982187|2932095|Superiority||Odds Ratio (OR)|27.744|||<|0.001|2-Sided|95.0|10.512||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 2:Turbuhaler + HandiHaler vs ELLIPTA|
1594780|NCT02982187|2932095|Superiority||Odds Ratio (OR)|29.114|||<|0.001|2-Sided|95.0|11.047||The upper bound of the 95% CI could not be calculated due to the low number of events and is therefore displayed as NA.||stratified exact logistic model||Odds ratio, 95% CI and P-value obtained from a stratified exact logistic model. Participant is included in the model as fixed strata, treatment option in the exact statement and period included as a fixed effect.|Sub study 1: DISKUS + HandiHaler vs ELLIPTA|
1594781|NCT02981342|2932108|Superiority||LSMean Difference|7.26|Standard Error of the Mean|7.57||0.344|2-Sided|95.0|-8.03|22.54|||Mixed Models Analysis|||Symptom Scales: Financial Difficulties|
1594782|NCT02981342|2932108|Superiority||LSMean Difference|1.51|Standard Error of the Mean|7.47||0.841|2-Sided|95.0|-13.57|16.59|||Mixed Models Analysis|||Symptom Scales: Financial Difficulties|
1594783|NCT02981342|2932108|Superiority||LSMean Difference|-4.8|Standard Error of the Mean|10.54||0.651|2-Sided|95.0|-26.08|16.48|||Mixed Models Analysis|||Symptom Scales: Diarrhoea|
1594784|NCT02981342|2932108|Superiority||LSMean Difference|-10.57|Standard Error of the Mean|10.58||0.323|2-Sided|95.0|-31.93|10.78|||Mixed Models Analysis|||Symptom Scales: Diarrhoea|
1594785|NCT02981342|2932108|Superiority||LSMean Difference|-9.97|Standard Error of the Mean|9.3||0.29|2-Sided|95.0|-28.75|8.8|||Mixed Models Analysis|||Symptom Scales: Constipation|
1594786|NCT02981342|2932108|Superiority||LSMean Difference|9.47|Standard Error of the Mean|9.23||0.311|2-Sided|95.0|-9.16|28.09|||Mixed Models Analysis|||Symptom Scales: Constipation|
1594787|NCT02981342|2932108|Superiority||LSMean Difference|3.02|Standard Error of the Mean|9.31||0.747|2-Sided|95.0|-15.77|21.82|||Mixed Models Analysis|||Symptom Scales: Appetite loss|
1594788|NCT02981342|2932108|Superiority||LSMean Difference|-2.79|Standard Error of the Mean|8.91||0.756|2-Sided|95.0|-20.78|15.21|||Mixed Models Analysis|||Symptom Scales: Appetite loss|
1594789|NCT02981342|2932108|Superiority||LSMean Difference|1.52|Standard Error of the Mean|7.99||0.85|2-Sided|95.0|-14.6|17.64|||Mixed Models Analysis|||Symptom Scales: Insomnia|
1594790|NCT02981342|2932108|Superiority||LSMean Difference|-7.02|Standard Error of the Mean|7.93||0.38|2-Sided|95.0|-23.01|8.96|||Mixed Models Analysis|||Symptom Scales: Insomnia|
1594791|NCT02981342|2932108|Superiority||LSMean Difference|4.86|Standard Error of the Mean|8.4||0.566|2-Sided|95.0|-12.08|21.8|||Mixed Models Analysis|||Symptom Scales: Dyspnoea|
1594792|NCT02981342|2932108|Superiority||LSMean Difference|-10.84|Standard Error of the Mean|8.44||0.206|2-Sided|95.0|-27.85|6.18|||Mixed Models Analysis|||Symptom Scales: Dyspnoea|
1594793|NCT02981342|2932108|Superiority||LSMean Difference|4.36|Standard Error of the Mean|8.69||0.618|2-Sided|95.0|-13.16|21.89|||Mixed Models Analysis|||Symptom Scales: Pain|
1594794|NCT02981342|2932108|Superiority||LSMean Difference|7.11|Standard Error of the Mean|8.67||0.417|2-Sided|95.0|-10.39|24.6|||Mixed Models Analysis|||Symptom Scales: Pain|
1594795|NCT02981342|2932108|Superiority||LSMean Difference|-3.9|Standard Error of the Mean|8.59||0.652|2-Sided|95.0|-21.23|13.43|||Mixed Models Analysis|||Symptom Scales: Nausea and Vomiting|
1594796|NCT02981342|2932108|Superiority||LSMean Difference|-1.45|Standard Error of the Mean|8.54||0.866|2-Sided|95.0|-18.66|15.77|||Mixed Models Analysis|||Symptom Scales: Nausea and Vomiting|
1594797|NCT02981342|2932108|Superiority||LSMean Difference|8.48|Standard Error of the Mean|7.54||0.267|2-Sided|95.0|-6.72|23.69|||Mixed Models Analysis|||Symptom Scales: Fatigue|
1594798|NCT02981342|2932108|Superiority||LSMean Difference|-0.77|Standard Error of the Mean|7.57||0.919|2-Sided|95.0|-16.03|14.49||Social Scales: Fatigue|Mixed Models Analysis|||Symptoms Scales: Fatigue|
1594799|NCT02981342|2932108|Superiority||LSMean Difference|-19.12|Standard Error of the Mean|7.71||0.017|2-Sided|95.0|-34.68|-3.55|||Mixed Models Analysis|||Functional Scales: Social functioning|
1594800|NCT02981342|2932108|Superiority||LSMean Difference|-4.02|Standard Error of the Mean|7.53||0.596|2-Sided|95.0|-19.23|11.19|||Mixed Models Analysis|||Functional Scales: Social functioning|
1594801|NCT02981342|2932108|Superiority||LSMean Difference|-5.25|Standard Error of the Mean|6.43||0.419|2-Sided|95.0|-18.22|7.73|||Mixed Models Analysis|||Functional Scales: Cognitive functioning|
1617850|NCT02397837|2970651|Other|||||||0.38|||||||t-test, 2 sided||||
1594807|NCT02981342|2932108|Superiority||LSMean Difference|-9.02|Standard Error of the Mean|6.75||0.189|2-Sided|95.0|-22.63|4.59|||Mixed Models Analysis|||Functional Scales: Physical functioning|
1594808|NCT02981342|2932108|Superiority||LSMean Difference|-2.79|Standard Error of the Mean|6.75||0.681|2-Sided|95.0|-16.4|10.82|||Mixed Models Analysis|||Functional Scales: Physical functioning|
1594809|NCT02981342|2932108|Superiority||LSMean Difference|-3.8|Standard Error of the Mean|6.06||0.533|2-Sided|95.0|-16.03|8.42|||Mixed Models Analysis|||Global health status|
1594810|NCT02981342|2932108|Superiority||LSMean Difference|-1.39|Standard Error of the Mean|5.98||0.818|2-Sided|95.0|-13.46|10.68|||Mixed Models Analysis|||Global health status|
1594811|NCT02981342|2932109|Superiority||LSMean Difference|0.46|Standard Error of the Mean|0.74||0.54|2-Sided|95.0|-1.04|1.96|||Mixed Models Analysis|||BPI-Mean Interference Score|
1594812|NCT02981342|2932109|Superiority||LSMean Difference|0.5|Standard Error of the Mean|0.7||0.475|2-Sided|95.0|-0.9|1.91|||Mixed Models Analysis|||BPI-Mean Interference Score|
1594813|NCT02981342|2932109|Superiority||LSMean Difference|0.52|Standard Error of the Mean|1.04||0.62|2-Sided|95.0|-1.58|2.62|||Mixed Models Analysis|||Pain Interfered Enjoyment of Life|
1594814|NCT02981342|2932109|Superiority||LSMean Difference|0.81|Standard Error of the Mean|0.97||0.407|2-Sided|95.0|-1.15|2.78|||Mixed Models Analysis|||Pain Interfered Enjoyment of Life|
1594815|NCT02981342|2932109|Superiority||LSMean Difference|0.9|Standard Error of the Mean|0.89||0.318|2-Sided|95.0|-0.9|2.71|||Mixed Models Analysis||||
1594816|NCT02981342|2932109|Superiority||LSMean Difference|0.75|Standard Error of the Mean|0.85||0.384|2-Sided|95.0|-0.97|2.48|||Mixed Models Analysis|||Pain Interfered with Sleep|
1594817|NCT02981342|2932109|Superiority||LSMean Difference|0.41|Standard Error of the Mean|0.88||0.644|2-Sided|95.0|-1.37|2.19|||Mixed Models Analysis|||Pain Interfered with relations.|
1594818|NCT02981342|2932109|Superiority||LSMean Difference|0.13|Standard Error of the Mean|0.82||0.876|2-Sided|95.0|-1.53|1.79|||Mixed Models Analysis|||Pain Interfered with Relations|
1594819|NCT02981342|2932109|Superiority||LSMean Difference|0.47|Standard Error of the Mean|0.85||0.583|2-Sided|95.0|-1.25|2.19|||Mixed Models Analysis|||Pain Interfered with Normal Work|
1594820|NCT02981342|2932109|Superiority||LSMean Difference|0.89|Standard Error of the Mean|0.8||0.272|2-Sided|95.0|-0.72|2.5|||Mixed Models Analysis|||Pain Interfered with Normal Work|
1594821|NCT02981342|2932109|Superiority||LSMean Difference|0.63|Standard Error of the Mean|0.92||0.497|2-Sided|95.0|-1.23|2.5|||Mixed Models Analysis|||Pain Interfered Walking Ability|
1594822|NCT02981342|2932109|Superiority||LSMean Difference|-0.15|Standard Error of the Mean|0.86||0.865|2-Sided|95.0|-1.89|1.6|||Mixed Models Analysis|||Pain Interfered Walking Ability|
1594823|NCT02981342|2932109|Superiority||LSMean Difference|-0.32|Standard Error of the Mean|0.69||0.65|2-Sided|95.0|-1.71|1.08|||Mixed Models Analysis|||Pain Interfered with Mood|
1594824|NCT02981342|2932109|Superiority||LSMean Difference|-0.06|Standard Error of the Mean|0.65||0.928|2-Sided|95.0|-1.37|1.25|||Mixed Models Analysis|||Pain Interfered with Mood|
1594825|NCT02981342|2932109|Superiority||LSMean Difference|-0.15|Standard Error of the Mean|0.79||0.848|2-Sided|95.0|-1.74|1.43|||Mixed Models Analysis|||Pain Interfered General Activity|
1594826|NCT02981342|2932109|Superiority||LSMean Difference|0.43|Standard Error of the Mean|0.73||0.565|2-Sided|95.0|-1.06|1.91|||Mixed Models Analysis|||Pain Interfered General Activity|
1594827|NCT02981342|2932109|Superiority||LSMean Difference|0.72|Standard Error of the Mean|0.85||0.405|2-Sided|95.0|-1.01|2.44|||Mixed Models Analysis|||Pain right now.|
1594828|NCT02981342|2932109|Superiority||LSMean Difference|0.75|Standard Error of the Mean|0.8||0.35|2-Sided|95.0|-0.85|2.36|||Mixed Models Analysis|||Pain Right Now|
1594829|NCT02981342|2932109|Superiority||LSMean Difference|0.04|Standard Error of the Mean|0.74||0.954|2-Sided|95.0|-1.45|1.54|||Mixed Models Analysis|||Pain on the Average|
1594830|NCT02981342|2932109|Superiority||LSMean Difference|0.69|Standard Error of the Mean|0.7||0.328|2-Sided|95.0|-0.72|2.11|||Mixed Models Analysis|||Pain on the Average|
1594831|NCT02981342|2932109|Superiority||LSMean Difference|-0.2|Standard Error of the Mean|0.7||0.776|2-Sided|95.0|-1.62|1.22|||Mixed Models Analysis|||Pain at its Least in Last 24 Hours|
1594832|NCT02981342|2932109|Superiority||LSMean Difference|0.48|Standard Error of the Mean|0.66||0.469|2-Sided|95.0|-0.85|1.8|||Mixed Models Analysis|||Pain at its Least in Last 24 Hours|
1594833|NCT02981342|2932109|Superiority||LSMean Difference|-0.31|Standard Error of the Mean|0.79||0.692|2-Sided|95.0|-1.91|1.28|||Mixed Models Analysis|||Pain at its Worst in Last 24 Hours|
1594834|NCT02981342|2932109|Superiority||LSMean Difference|0.65|Standard Error of the Mean|0.74||0.383|2-Sided|95.0|-0.84|2.13|||Mixed Models Analysis|||Pain at its Worst in Last 24 Hours|
1594835|NCT02981342|2932111|Superiority||Hazard Ratio (HR)|1.533||||0.2477|2-Sided|95.0|0.746|3.15|||Log Rank||||
1594836|NCT02981342|2932111|Superiority||Hazard Ratio (HR)|1.6||||0.1938|2-Sided|95.0|0.782|3.272|||Log Rank||||
1594837|NCT02981342|2932113|Superiority|||||||0.3017|||||||Cochran-Mantel-Haenszel||||
1594838|NCT02981342|2932113|Superiority|||||||1|||||||Cochran-Mantel-Haenszel||||
1594839|NCT02981342|2932118|Superiority|||||||0.3017|||||||Cochran-Mantel-Haenszel||||
1594840|NCT02981342|2932118|Superiority|||||||1|||||||Cochran-Mantel-Haenszel||||
1594841|NCT02981342|2932119|Superiority|||||||0.0123|||||||Log Rank||||
1594842|NCT02981342|2932119|Superiority|||||||0.0085|||||||Log Rank||||
1594843|NCT02981342|2932120|Superiority|||||||0.023|||||||Cochran-Mantel-Haenszel||||
1594844|NCT02981342|2932120|Superiority|||||||0.0495|||||||Cochran-Mantel-Haenszel||||
1594845|NCT02980523|2932176|Non-Inferiority|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.829|||||||Chi-squared, Corrected||||
1594846|NCT02980523|2932177|Non-Inferiority|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.216|||||||Chi-squared, Corrected||||
1594847|NCT02980523|2932178|Non-Inferiority|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.003|||||||Chi-squared, Corrected||||
1620526|NCT02314923|2977569|Other||||||<|0.348|||||||ANOVA||||
1594848|NCT02980523|2932179|Non-Inferiority|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.001|||||||Chi-squared, Corrected||||
1594849|NCT02980523|2932180|Non-Inferiority|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.341|||||||Chi-squared, Corrected||||
1594850|NCT02980523|2932181|Non-Inferiority|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.372|||||||Chi-squared, Corrected||||
1594851|NCT02980523|2932182|Non-Inferiority or Equivalence|The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.||||||0.002|||||||Chi-squared||||
1594852|NCT02980133|2932193|Superiority||LS mean difference|7.0|||<|0.001|2-Sided|95.0|4.1|9.8||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (ICS or NCS), and IMP treatment group.|
1594853|NCT02980133|2932193|Superiority||Least square (LS) mean difference|6.0|||<|0.001|2-Sided|95.0|3.2|8.8||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (inhaled corticosteroid [ICS] or noncorticosteroid [NCS]), and investigational medicinal product (IMP) treatment group.|
1594854|NCT02980133|2932194|Superiority||LS mean difference|1.9||||0.285|2-Sided|95.0|-1.6|5.3||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using an ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, (pooled) investigational center, previous therapy (ICS or NCS), and IMP treatment group.|
1594855|NCT02980042|2932204|Superiority||Risk Ratio (RR)|3.0||||0.0209|2-Sided|95.0|1.126|7.9932|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.|||
1594856|NCT02980042|2932204|Superiority||Risk Ratio (RR)|0.8571||||0.593|2-Sided|95.0|0.4868|1.5093|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.|||
1594857|NCT02980042|2932204|Superiority||Risk Ratio (RR)|0.2857||||0.0075|2-Sided|95.0|0.1072|0.7613|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.|||
1594858|NCT02980042|2932208|Superiority||Risk Ratio (RR)|0.8571||||0.6474|2-Sided|95.0|0.4385|1.6753|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.|||
1594859|NCT02980042|2932208|Superiority||Risk Ratio (RR)|0.2857||||0.0053|2-Sided|95.0|0.1006|0.8114|||Generalized estimating equations|GEE was used because there are repeated measures on subjects.|Switching group Day 15 was compared to combined Comparator group.||
1594860|NCT02980042|2932208|Superiority||Risk Ratio (RR)|1.0||||1|2-Sided|95.0|0.5299|1.8872|||Generalized estimating equations|GEE was used because there are repeated measures on subjects|Comparing Switching group Day 1 to combined Comparator group||
1594861|NCT02980042|2932209|Superiority||Risk Ratio (RR)|0.6616||||0.1996|2-Sided|95.0|0.3666|1.1942|||Generalized estimating equations|GEE was necessary because there are repeated measures on subjects.|This is comparing the Switching group to the Comparator group||
1594862|NCT02979613|2932242|Superiority||||||<|0.001||||||P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.|Wilcoxon rank sum test||||
1594863|NCT02979613|2932244|Superiority||Difference in LSM|1.848|||<|0.001|2-Sided|95.0|1.241|2.455|||ANOVA|||P-values, difference in the LSM, and its 95% CI were derived from the ANOVA model including treatment as a fixed effect.|
1594864|NCT02979613|2932246|Superiority||Difference in LSM|1.17|||<|0.001|2-Sided|95.0|0.801|1.539|||ANOVA|||P-values, difference in the LSM, and its 95% CI were derived from the ANOVA model including treatment as a fixed effect.|
1594865|NCT02979613|2932248|Superiority||difference in LSM|-0.02||||0.018|2-Sided|95.0|-0.03|0.0|||ANOVA|||P-value, difference in least squares mean (LSM), and its 95% CI were derived from analysis of variance (ANOVA) model with baseline age groups (< 50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.|
1594866|NCT02979613|2932251|Superiority||Difference in the Percentages|23.8||||0.014|2-Sided|95.0|5.3|42.3||P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH proportion, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria|
1594867|NCT02979613|2932251|Superiority||Difference in the Percentages|14.1||||0.34|2-Sided|95.0|-16.4|44.6||P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH proportion, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory criteria|
1594868|NCT02979613|2932252|Superiority||Difference in the Percentages|3.8||||0.31|2-Sided|95.0|-3.7|11.4||P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH proportion, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.|AASLD Criteria|
1594869|NCT02979613|2932252|Superiority||Difference in the Percentages|4.5||||0.14|2-Sided|95.0|-1.6|10.6||P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH proportion, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.|Central Laboratory Criteria|
1594870|NCT02979613|2932256|Superiority||Difference in the Percentages|-2.0||||0.028|2-Sided|95.0|-4.4|0.3||P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH proportion, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.||
1620527|NCT02314923|2977569|Other||||||<|0.001|||||||ANOVA||||
1594871|NCT02979613|2932259|Superiority||Difference in the Percentages|2.7||||0.13|2-Sided|95.0|-2.3|7.7||P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH proportion, adjusted by baseline age groups.||
1594872|NCT02979613|2932260|Superiority||Difference in the Percentages|1.4||||0.73|2-Sided|95.0|-7.2|10.1||P-value was from the CMH test, stratified by baseline age groups (< 50, ≥ 50 years).|Cochran-Mantel-Haenszel||Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH proportion, adjusted by baseline age groups.||
1594873|NCT02979613|2932264|Non-Inferiority|Non-inferiority was assessed using a 95% CI approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||2-Sided|95.0|-3.7|3.7|||||Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH proportion, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.||
1594874|NCT02979613|2932266|Non-Inferiority|Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.|Difference in the Percentages|0.0|||||2-Sided|95.0|-1.9|2.0|||||Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted Mantel-Haenszel (MH) proportion, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.|The null hypothesis was that the TAF group is at least 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48.|
1594875|NCT02979535|2932280|Other||GMT ratio|0.931|||||2-Sided|95.0|0.733|1.18||||||Dengue Virus Serotype 4|
1594876|NCT02979535|2932280|Other||GMT ratio|0.921|||||2-Sided|95.0|0.727|1.17||||||Dengue Virus Serotype 3|
1594877|NCT02979535|2932280|Other||GMT ratio|0.911|||||2-Sided|95.0|0.654|1.27||||||Dengue Virus Serotype 2|
1594878|NCT02979535|2932280|Other||GMT ratio|0.977|||||2-Sided|95.0|0.653|1.46||||||Dengue Virus Serotype 1|
1594879|NCT02979535|2932281|Other||GMT ratio|0.986|||||2-Sided|95.0|0.803|1.21||||||Antigen HPV-18|
1594880|NCT02979535|2932281|Other||GMT ratio|0.947|||||2-Sided|95.0|0.773|1.16||||||Antigen HPV-16|
1594881|NCT02979431|2932296|Superiority||Difference in LS means|-0.2156|Standard Error of the Mean|0.5842|=|0|2-Sided||||||Mixed Models Analysis||||
1594882|NCT02979431|2932296|Superiority||Difference in LS means|-0.4904|Standard Error of the Mean|0.5862|=|0|2-Sided||||||Mixed Models Analysis||||
1594883|NCT02979431|2932296|Superiority||Mean Difference (Net)|-0.6452|Standard Error of the Mean|0.5843|=|0|2-Sided||||||Mixed Models Analysis|||A comparison for change from Baseline in GSS to Day 2, 5 hours post-dose was performed using a contrast analysis on a longitudinal mixed model with random factor subject and fixed effects baseline value, treatment group and timepoint, including the treatment-by-timepoint interaction term. All data up to + including Day 3 were used in the longitudinal mixed model. The Kenward-Roger approximation of degrees of freedom was used.The model was fitted using an unstructured variance-covariance matrix.|
1594884|NCT02979431|2932297|Superiority||||||<|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.|
1594885|NCT02979431|2932297|Superiority||||||=|0|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.|
1594886|NCT02979431|2932297|Superiority||||||<|0.001|||||||Log Rank|||The primary endpoint was analysed using log-rank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05.|
1594887|NCT02979262|2932299|Superiority||||||<|0.01|||||||GEE||||
1594888|NCT02979262|2932300|Superiority||||||>|0.1|||||||GEE||||
1594889|NCT02979262|2932301|Superiority||||||>|0.1|||||||GEE||||
1594890|NCT02979262|2932302|Superiority||||||>|0.1|||||||GEE||||
1594891|NCT02979262|2932303|Superiority||||||<|0.01|||||||GEE||||
1594892|NCT02979262|2932304|Superiority||||||>|0.1|||||||Repeated Measures GLM|Time 2 at 16 weeks|||
1594893|NCT02979197|2932305|Superiority|||||||0.9397|||||||ANCOVA|Adjusted mean = 0.19 μmol/L; 95% confidence interval = -4.9 to 5.2||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Placebo and Placebo+Placebo arms.|
1594894|NCT02979197|2932305|Superiority|||||||0.541|||||||ANCOVA|Adjusted mean = -1.56 μmol/L; 95% confidence interval = -6.6 to 3.5||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Celecoxib and Placebo+Placebo arms.|
1594895|NCT02979197|2932305|Superiority|||||||0.2022|||||||ANCOVA|Adjusted mean = -1.76 μmol/L; 95% confidence interval = -4.5 to 1.0||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the comparison between the Amlodipine+Celecoxib and Amlodipine+Placebo arms.|
1594896|NCT02979197|2932305|Superiority|||||||0.4184|||||||ANCOVA|Adjusted mean = -1.92 μmol/L; 95% confidence interval = -6.6 to 2.8||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Placebo+Placebo arm from baseline to Day 14.|
1594897|NCT02979197|2932305|Superiority|||||||0.075|||||||ANCOVA|Adjusted mean = -1.72 μmol/L; 95% confidence interval = -3.6 to 0.2||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Amlodipine+Placebo arm from baseline to Day 14.|
1594926|NCT02977507|2932347|Other|||||||0.004|||||||Paired t-test|||Testing hypothesis was that the mean change from baseline was zero.|
1598431|NCT02900378|2936703|Other|||||||0.5946|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9|
1594898|NCT02979197|2932305|Superiority|||||||0.0005|||||||ANCOVA|Adjusted mean = -3.48 μmol/L; 95% confidence interval = -5.4 to -1.6||Renal function was analyzed by evaluating the decreases in serum creatinine from baseline to Day 14 for each treatment arm and between treatment arms by ANCOVA. This analysis was for the Amlodipine+Celecoxib arm from baseline to Day 14.|
1594899|NCT02979197|2932306|Superiority|||||||0.215|||||||t-test, 2 sided|||For this analysis, all values below the limit of quantification (BLQ) were treated as 0.04 ng/mL. Assignment of BLQ values to a nonzero number allowed computation of the log transformation. The selection of 0.04 ng/mL was based on the lower limit of quantification of the validated bioanalytical method (0.05 ng/mL) and selecting the next lowest number at the hundredth decimal place.|
1594900|NCT02979197|2932307|Superiority|||||||0.226|||||||t-test, 2 sided|||For this analysis, all values below the limit of quantification were treated as 0.|
1594901|NCT02979197|2932308|Superiority|||||||0.555|||||||Regression, Logistic|TEAE (1=at least one TEAE occurred for the subject; 0=otherwise) as dependent variable and treatment as fixed effect.|||
1594902|NCT02979197|2932308|Superiority|Differences in the occurrence of TEAEs between treatment arms were evaluated using Chi-square test.||||||0.675|||||||Chi-squared|Computed on the number of subjects who had at least one TEAE.|||
1594903|NCT02979197|2932309|Superiority|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib improved creatinine clearance to a greater degree than Amlodipine+Placebo.||||||0.668|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in creatinine clearance was the 4th of 4 secondary efficacy endpoints.|
1594904|NCT02979197|2932310|Superiority|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib lowered DBP24h to a greater degree than Amlodipine+Placebo.||||||0.5|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in DBP24h was the 3rd of the 4 secondary efficacy endpoints.|
1594905|NCT02979197|2932311|Superiority|A two-sample t-test for superiority was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib lowered SBP24h to a greater degree than Amlodipine+Placebo.||||||0.826|||||||t-test, 2 sided|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in SBP24h was the 2nd of the four secondary efficacy endpoints.|
1594906|NCT02979197|2932312|Other|ANOVA F-test was used to compare the mean changes in body weight from baseline to end of treatment among the three treatment arms. The omni-bus test was to conclude if any differences existed.||||||0.006|||||||ANOVA|||A serial gatekeeping strategy was used for secondary efficacy analyses. If, and only if, statistical significance was achieved for the primary endpoint (SBPday), a secondary hierarchical analysis was to be used to evaluate secondary efficacy endpoints and was only to proceed from one to the next if the alpha was met for the prior; if the alpha was not met, analysis was performed for informational purposes only. Mean change in body weight was the 1st of the four secondary efficacy endpoints.|
1594907|NCT02979197|2932313|Non-Inferiority|A two-sample t-test was used to test the one-sided hypothesis that treatment with Amlodipine+Celecoxib (arm 1) was non-inferior to half of the effect achieved with Amlodipine+Placebo (arm 2). The primary efficacy endpoint was considered met if the lower limits of the 97.5% one-side confidence interval (CI) for the difference in SBPday change in arm 1 and 50% of the mean change in arm 2 was less than 0.||||||0.024|||||||t-test, 2 sided|||LOCF method was used. Primary efficacy analysis was based on the difference between the Amlodipine+Celecoxib and Amlodipine+Placebo (arms 1 and 2, respectively) in the mean change in SBPday from Baseline to final (Day 13), where a subject completed the 14-day treatment plan, or to Day 6, where a subject was withdrawn from treatment before the Day 13 dose but after the Day 6 dose, or to baseline, where a subject was withdrawn before the Day 6 dose.|
1594908|NCT02978339|2932324|Superiority|||||||0.93|||||||t-test, 2 sided||||
1594909|NCT02978339|2932325|Superiority|||||||0.06|||||||t-test, 2 sided||||
1594910|NCT02978339|2932326|Superiority|||||||0.15|||||||t-test, 2 sided||||
1594911|NCT02978339|2932327|Superiority|||||||0.41|||||||t-test, 2 sided||||
1594912|NCT02978339|2932328|Superiority|||||||0.91|||||||t-test, 2 sided||||
1594913|NCT02978339|2932329|Superiority|||||||0.59|||||||t-test, 2 sided||||
1594914|NCT02978339|2932330|Superiority|||||||0.03|||||||t-test, 2 sided||||
1594915|NCT02978157|2932331|Superiority||||||<|0.001|||||||Chi-squared||||
1594916|NCT02977572|2932340|Superiority or Other|||||||1|||||||Chi-squared|||Based upon previous results, the investigators considered that the need for an intubation could be reduced by 15% [19% in the CPAP group (control) vs. 4% in the NIV group (study)]. The estimated sample size was 55 participants in each group (confidence interval [1-α] = 90% and power [1-β] = 85%).|
1594917|NCT02977507|2932341|Other|||||||0.435|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.|
1594918|NCT02977507|2932341|Other|||||||0.81|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.|
1594919|NCT02977507|2932341|Other|||||||0.502|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.|
1594920|NCT02977507|2932341|Other|||||||0.821|||||||Paired t-test|||Erythema: Testing hypothesis is that the mean change from baseline is zero.|
1594921|NCT02977507|2932341|Other|||||||9e-05|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.|
1594922|NCT02977507|2932341|Other|||||||0.569|||||||Paired t-test|||Melanin index: Testing hypothesis is that the mean change from baseline is zero.|
1620528|NCT02314923|2977569|Other||||||<|0.001|||||||ANOVA||||
1594931|NCT02976519|2932350|Other||Slope|1.0924|Standard Error of the Mean|0.0793|||2-Sided|95.0|0.9296|1.2551|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|AUC0-12,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.|
1594932|NCT02976519|2932350|Other||Slope|1.2743|Standard Error of the Mean|0.0739|||2-Sided|95.0|1.1231|1.4255|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|AUC0-12. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.|
1594933|NCT02976519|2932351|Other||Slope|1.1361|Standard Error of the Mean|0.0859|||2-Sided|95.0|0.9598|1.3123|||||Based on the estimate for slope parameter (β), a 2-sided 95% CI for the slope was computed. Standard error of the mean is actually standard error of slope.|Cmax,13. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.|
1594934|NCT02976519|2932351|Other||Slope|1.2705|Standard Error of the Mean|0.0801|||2-Sided|95.0|1.1067|1.4343|||||Based on the estimate for slope parameter (β), a 2-sided 95% confidence interval (CI) for the slope was computed. Standard error of the mean is actually standard error of slope.|Cmax. The basic model used for the investigation of dose proportionality was a power model (regression model applied to log-transformed data) that described the functional relationship between the dose and PK endpoints.|
1594935|NCT02975804|2932385|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1594936|NCT02975804|2932386|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1594937|NCT02975804|2932390|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1594938|NCT02975804|2932391|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1594939|NCT02975804|2932392|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1594940|NCT02975804|2932393|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1594941|NCT02975804|2932394|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1594942|NCT02975804|2932395|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1594943|NCT02975557|2932411|Other|||||||1|||||||Fisher Exact|The type I error was adjusted by using the alpha spending function approach with O'Brien-Fleming type boundaries.||We evaluated if the categorical type of tolerability measure is different between control (Artificial Tears) and intervention (Brimonidine, including both 0.15% high and 0.075% low doses groups).|
1594944|NCT02974868|2932432|Other||Difference in Percentage from Placebo|61.7|||<|0.0001|2-Sided|90.0|48.2|73.6|||Chan and Zhang method||||
1594945|NCT02974868|2932432|Other||Difference in Percentage from Placebo|47.9|||<|0.0001|2-Sided|90.0|34.2|60.7|||Chan and Zhang method||||
1594946|NCT02974868|2932437|Other||Mean of Difference from Placebo|46.61|Standard Error of the Mean|10.51|<|0.0001|2-Sided|90.0|29.02|64.2|||Mixed Model Repeated Measure|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.|||
1594947|NCT02974868|2932437|Other||Mean of Difference from Placebo|25.78|Standard Error of the Mean|10.64|<|0.0094|2-Sided|90.0|7.98|43.58|||Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.|||
1594948|NCT02974868|2932438|Superiority||Mean of Difference from Placebo|49.18|Standard Error of the Mean|6.35|<|0.0001|2-Sided|95.0|36.62|61.74||Hochberg P-value (one-sided)|Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.|||
1594949|NCT02974868|2932438|Superiority||Mean of Difference from Placebo|31.14|Standard Error of the Mean|6.25|<|0.0001|2-Sided|95.0|18.78|43.5||Hochberg P-value (one-sided)|Mixed Model Repeated Measure (MMRM)|MMRM contains fixed factors of treatment, week, baseline, treatment by week and treatment by baseline interaction and a random effect for subject.|||
1594950|NCT02974855|2932455|Superiority||ratio|0.12|||<|0.0001|2-Sided|80.0|0.08|0.2|||Negative Binomial Model|||On-Study versus Pre-Treatment|
1594951|NCT02974855|2932455|Superiority||ratio|0.04|||<|0.0005|2-Sided|80.0|0.01|0.14|||Negative Binomial Model|||On-Study versus Pre-Treatment|
1594952|NCT02974855|2932455|Superiority||ratio|0.2|||<|0.0154|2-Sided|80.0|0.09|0.47|||Negative Binomial Model|||On-Study versus Pre-Treatment|
1594953|NCT02974855|2932455|Superiority||ratio|0.1|||<|0.0002|2-Sided|80.0|0.04|0.22|||Negative Binomial Model|||On-Study versus Pre-Treatment|
1594954|NCT02974855|2932455|Superiority||ratio|0.18|||<|0.0001|2-Sided|80.0|0.11|0.31|||Negative Binomial Model|||On-Study versus Pre-Treatment|
1594955|NCT02974855|2932455|Superiority|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is <1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand >0.3.|ratio|0.09|||<|0.0001|2-Sided|80.0|0.05|0.16|||Negative Binomial Model|||The comparator was the Historical on Demand Group|
1594956|NCT02974855|2932455|Superiority|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is <1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand >0.3.|ratio|0.03|||<|0.0005|2-Sided|80.0|0.01|0.1|||Negative Binomial Model|||The comparator was the Historical on Demand Group|
1594957|NCT02974855|2932455|Superiority|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is <1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand >0.3.|ratio|0.15|||<|0.0002|2-Sided|80.0|0.08|0.29|||Negative Binomial Model|||The comparator was the Historical on Demand Group|
1594958|NCT02974855|2932455|Superiority|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is <1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand >0.3.|ratio|0.05|||<|0.0001|2-Sided|80.0|0.02|0.14|||Negative Binomial Model|||The comparator was the Historical on Demand Group|
1594959|NCT02974855|2932455|Superiority|Prophylactic treatment with PF-06741086 will be considered superior to On Demand treatment with respect to ABR reduction if 1) the upper limit of the 2-sided 80%CI of the ratio of ABR in PF/historical On Demand is <1 and 2) the estimate of the ratio of ABR in PF/historical On Demand ≤0.3. Drug will be considered not superior to On Demand treatment if the lower limit of the 2-sided 80%CI of the ratio of PF/historical On Demand >0.3.|ratio|0.15|||<|0.0002|2-Sided|80.0|0.08|0.29|||Negative Binomial Model|||The comparator was the Historical on Demand Group|
1594960|NCT02974543|2932472|Superiority||||||<|0.05|||||||Mixed Models Analysis||||
1594961|NCT02974543|2932473|Superiority||||||<|0.05|||||||Mixed Models Analysis||||
1594962|NCT02973100|2932507|Superiority||Mean Difference (Final Values)|-2.6|||<|0.001|2-Sided|95.0|-3.7|-1.5|||Mixed Models Analysis||||
1594963|NCT02973100|2932507|Superiority||Mean Difference (Final Values)|-2.4|||<|0.001|2-Sided|95.0|-3.4|-1.3|||Mixed Models Analysis||||
1594964|NCT02973100|2932507|Superiority||Mean Difference (Final Values)|-1.2|||<|0.025|2-Sided|95.0|-2.3|-0.2|||Mixed Models Analysis||||
1594965|NCT02973100|2932508|Superiority||Mean Difference (Final Values)|-1.42|||<|0.001|2-Sided|95.0|-2.12|-0.72|||Mixed Models Analysis||||
1594966|NCT02973100|2932508|Superiority||Mean Difference (Final Values)|-1.23|||<|0.001|2-Sided|95.0|-1.91|-0.54|||Mixed Models Analysis||||
1594967|NCT02973100|2932508|Superiority||Mean Difference (Final Values)|-1.32|||<|0.001|2-Sided|95.0|-2.02|-0.62|||Mixed Models Analysis||||
1594968|NCT02973100|2932509|Superiority||Odds Ratio (OR)|21.852|||<|0.001|2-Sided|95.0|7.672|62.242|||Regression, Logistic||||
1594969|NCT02973100|2932509|Superiority||Odds Ratio (OR)|27.906|||<|0.001|2-Sided|95.0|9.238|84.3|||Regression, Logistic||||
1594970|NCT02973100|2932509|Superiority||Odds Ratio (OR)|24.489|||<|0.001|2-Sided|95.0|8.368|71.667|||Regression, Logistic||||
1594971|NCT02973100|2932510|Superiority||Mean Difference (Final Values)|-0.96|||<|0.001|2-Sided|95.0|-1.24|-0.69|||Mixed Models Analysis||||
1594972|NCT02973100|2932510|Superiority||Mean Difference (Final Values)|-0.87|||<|0.001|2-Sided|95.0|-1.14|-0.6|||Mixed Models Analysis||||
1594973|NCT02973100|2932510|Superiority||Mean Difference (Final Values)|-0.8|||<|0.001|2-Sided|95.0|-1.07|-0.53|||Mixed Models Analysis||||
1594974|NCT02972632|2932518|Other||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline|
1594975|NCT02972632|2932519|Other||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline|
1594976|NCT02972632|2932520|Other||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline|
1594977|NCT02972632|2932521|Other||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline|
1594978|NCT02972632|2932521|Other||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline|
1594979|NCT02972632|2932522|Other||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline|
1594980|NCT02972632|2932522|Other||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline|
1594981|NCT02972632|2932523|Other||||||<|0.001|||||||t-test, 2 sided|||Change at Week 12 relative to baseline|
1594982|NCT02972632|2932523|Other||||||<|0.001|||||||t-test, 2 sided|||Change at Week 6 relative to baseline|
1594983|NCT02971631|2932549|Superiority|||||||0.84|||||||t-test, 2 sided||||
1594984|NCT02971631|2932550|Superiority|||||||1|||||||Other|0 events over whole study, no statistical test appropriate|||
1594985|NCT02971631|2932551|Superiority|||||||0.88|||||||t-test, 2 sided|Paired analysis||Post-meal|
1594986|NCT02971631|2932551|Superiority|||||||0.95|||||||t-test, 2 sided|Paired analysis||Pre-meal|
1594987|NCT02971631|2932551|Superiority|||||||0.06||||||Paired analysis|t-test, 2 sided|||Post-OGTT|
1594988|NCT02971631|2932551|Superiority|||||||0.26|||||||t-test, 2 sided|Paired analysis||Baseline|
1594989|NCT02971631|2932552|Superiority|||||||0.2|||||||t-test, 2 sided|Paired analysis||Post-meal|
1594990|NCT02971631|2932552|Superiority|||||||0.39|||||||t-test, 2 sided|Paired analysis||Pre-meal|
1594991|NCT02971631|2932552|Superiority|||||||0.58|||||||t-test, 2 sided|Paired analysis||Post-OGTT|
1594992|NCT02971631|2932552|Superiority|||||||0.2|||||||t-test, 2 sided|Paired analysis||Baseline|
1594993|NCT02971631|2932554|Superiority|||||||0.79|||||||t-test, 2 sided|Paired analysis||For meal consumption rate|
1594994|NCT02971631|2932555|Superiority|||||||0.03|||||||t-test, 2 sided|Paired analysis|||
1594995|NCT02971631|2932556|Superiority|||||||0.008|||||||t-test, 2 sided|Paired analysis|||
1594996|NCT02971293|2932567|Superiority|||||||0.046|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1594997|NCT02971293|2932567|Superiority|||||||0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1594998|NCT02971293|2932567|Superiority|||||||0.213|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1594999|NCT02971293|2932568|Superiority|||||||0.084|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595000|NCT02971293|2932568|Superiority|||||||0.014|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595058|NCT02969018|2932744|Other||Odds Ratio (OR)|3.86|||||2-Sided|90.0|1.17|12.74|||||||Logistic regression
1620529|NCT02314923|2977569|Other||||||<|0.022|||||||ANOVA||||
1595001|NCT02971293|2932568|Superiority|||||||0.477|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595002|NCT02971293|2932569|Superiority|||||||0.047|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595003|NCT02971293|2932569|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595004|NCT02971293|2932569|Superiority||||||<|0.018|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595005|NCT02971293|2932570|Superiority|||||||0.03|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595006|NCT02971293|2932570|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595007|NCT02971293|2932570|Superiority||||||<|0.064|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595008|NCT02971293|2932571|Superiority|||||||0.013|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595009|NCT02971293|2932571|Superiority|||||||0.005|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595010|NCT02971293|2932571|Superiority|||||||0.748|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595011|NCT02971293|2932572|Superiority|||||||0.333|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595012|NCT02971293|2932572|Superiority|||||||0.138|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595013|NCT02971293|2932572|Superiority|||||||0.621|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595014|NCT02971293|2932573|Superiority|||||||0.015|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595015|NCT02971293|2932573|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595016|NCT02971293|2932573|Superiority||||||<|0.111|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595017|NCT02971293|2932574|Superiority|||||||0.06|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595018|NCT02971293|2932574|Superiority|||||||0.002|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595019|NCT02971293|2932574|Superiority|||||||0.205|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595020|NCT02971293|2932575|Superiority||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595021|NCT02971293|2932575|Superiority||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595022|NCT02971293|2932575|Superiority||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595023|NCT02971293|2932576|Superiority|||||||0.279|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595024|NCT02971293|2932576|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595025|NCT02971293|2932576|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595026|NCT02971293|2932577|Superiority|||||||0.092|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595027|NCT02971293|2932577|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595028|NCT02971293|2932577|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595029|NCT02971293|2932578|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595059|NCT02969018|2932744|Other||Odds Ratio (OR)|2.11|||||2-Sided|90.0|0.59|7.55|||||||Logistic regression
1620530|NCT02314923|2977569|Other||||||<|0.757|||||||ANOVA||||
1595030|NCT02971293|2932578|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595031|NCT02971293|2932578|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595032|NCT02971293|2932579|Superiority|||||||0.02|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595033|NCT02971293|2932579|Superiority||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595034|NCT02971293|2932579|Superiority||||||<|0.001|||||||ANCOVA|Fixed effect: treatment, sequence, period, treatment*day. Repeat factor: day. Random effect: patient nested in sequence. Continuous covar: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595035|NCT02971293|2932580|Superiority|||||||0.201|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595036|NCT02971293|2932580|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595037|NCT02971293|2932580|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595038|NCT02971293|2932581|Superiority|||||||0.011|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595039|NCT02971293|2932581|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595040|NCT02971293|2932581|Superiority||||||<|0.002|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595041|NCT02971293|2932593|Superiority|||||||0.02|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs AZD8871 100 µg|
1595042|NCT02971293|2932593|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 600 µg vs placebo|
1595043|NCT02971293|2932593|Superiority||||||<|0.001|||||||ANCOVA|Fixed effects: treatment, sequence, period. Random effect for patient nested within sequence. Continuous covariate: baseline.||Comparison of AZD8871 100 µg vs placebo|
1595044|NCT02971007|2932608|Other|Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.||||||||||||||||No formal sample size calculations were made. The sample size was determined empirically rather than with a specific statistical rationale and is considered sufficient to achieve the study objectives of this proof of concept study. Women with moderate to severe Vulvovaginal candidiasis were randomized in a 1:1:1 ratio to 1 of 3 treatment groups, stratified by signs and symptoms composite score of up to 12 (moderate) and greater than 13 (severe).|Statistical analyses primarily descriptive with no formal statistical hypothesis testing. Summary statistics are presented by treatment group. For continuous variables, the number of observations, mean, standard deviation, median, minimum and maximum are provided as summary statistics.
1595045|NCT02970669|2932614|Superiority||Mean Difference (Net)|2.478||||0.0121|2-Sided|95.0|0.553|4.403|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.|||
1595046|NCT02970669|2932615|Superiority||Mean Difference (Net)|2.038||||0.057|2-Sided|95.0|-0.062|4.138|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.|||
1595047|NCT02970669|2932617|Superiority||Mean Difference (Net)|293.6||||0.6316|2-Sided|95.0|-916.5|1503.8|||ANCOVA|model with treatment group as a class variable and the baseline value as a continuous covariate.|||
1595048|NCT02970669|2932618|Superiority||Ratio of Geometric Means (SacVal/Ena)|0.9456||||0.0895|2-Sided|95.0|0.8863|1.0088|||ANCOVA|model for a log-scaled response with treatment group as a class variable and the baseline value in logarithmic scale as a continuous covariate.|||
1595049|NCT02970162|2932632|Superiority|||||||0.0112|||||||Fisher Exact||||
1595050|NCT02970162|2932633|Superiority|||||||0.002|||||||Wilcoxon Rank Sum Test||||
1595051|NCT02970162|2932634|Superiority||LS means|2.95||||0.0003|2-Sided|95.0|1.53|4.38||CFB for SGI score was modeled as the response, with fixed effects terms for treatment and SGI at Baseline|Fixed effects linear model|This statistical test applies to the change from baseline SGI scores to Day 4 values row.|||
1595052|NCT02970162|2932635|Superiority|||||||0.0004||||||LS means|Least square means|Fixed effects treatment and QMG at Baseline. Between-treatment difference in LS means (95% CI) -6.54 (-9.78, -3.29).|||
1595053|NCT02969655|2932658|Superiority||Odds Ratio (OR)|0.76||||0.7442|2-Sided|95.0|0.34|1.71||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment and Baseline Hgb.||
1595054|NCT02969655|2932659|Non-Inferiority|Non-inferiority was established if the lower limit of the 95% CI was greater than -1.0 g/dL. Even if the 95% CI for the difference was completely negative (i.e. lied fully within the range -1.0 to <0 g/dL) non-inferiority was concluded on condition that the mean Hgb estimated in the daprodustat group was within the target range.|Mean Difference (Final Values)|0.06|||<|0.0001|2-Sided|95.0|-0.11|0.23||The p value on this table is one-sided and calculated for the non-inferiority assessment.|Mixed model repeated measures (MMRM)||Analysis was performed by a MMRM with covariates of treatment, Baseline Hgb, visit, treatment-by-visit interaction, Baseline-by-visit interaction.||
1595055|NCT02969044|2932729|Superiority||Mean Difference (Net)|-9.25|||<|0.001|2-Sided|95.0|-14.75|-3.79|||ANCOVA||||
1595060|NCT02969018|2932744|Other||Odds Ratio (OR)|41.67|||||2-Sided|90.0|10.8|160.68|||||||Logistic regression
1595061|NCT02969018|2932744|Other||Odds Ratio (OR)|2.11|||||2-Sided|90.0|0.59|7.55|||||||Logistic regression
1595062|NCT02969018|2932744|Other||Odds Ratio (OR)|9.09|||||2-Sided|90.0|2.71|30.48|||||||Logistic regression
1595063|NCT02969018|2932744|Other||Odds Ratio (OR)|2.12|||||2-Sided|90.0|0.61|7.36|||||||Logistic regression
1595064|NCT02969018|2932744|Other||Odds Ratio (OR)|10.0|||||2-Sided|90.0|2.95|33.87|||||||Logistic regression
1595065|NCT02969018|2932745|Other||Least Squares Mean Difference|-4.66|Standard Error of the Mean|2.163||0.0488|2-Sided|90.0|-8.24|-1.09||Hochberg adjusted p-value|Mixed Models Analysis||||
1595066|NCT02969018|2932745|Other||Least Squares Mean Difference|-6.06|Standard Error of the Mean|2.255||0.0158|2-Sided|90.0|-9.79|-2.33||Hochberg adjusted p-value|Mixed Models Analysis||||
1595067|NCT02969018|2932745|Other||Least Squares Mean Difference|-10.07|Standard Error of the Mean|2.152|<|0.0001|2-Sided|90.0|-13.63|-6.51||Hochberg adjusted p-value|Mixed Models Analysis||||
1595068|NCT02969018|2932745|Other||Least Squares Mean Difference|-2.93|Standard Error of the Mean|2.238|<|0.0963|2-Sided|90.0|-6.63|0.77||Hochberg adjusted p-value|Mixed Models Analysis||||
1595069|NCT02969018|2932745|Other||Least Squares Mean Difference|-7.07|Standard Error of the Mean|2.233|<|0.0046|2-Sided|90.0|-10.76|-3.37||Hochberg adjusted p-value|Mixed Models Analysis||||
1595070|NCT02969018|2932745|Other||Least Squares Mean Difference|-3.34|Standard Error of the Mean|2.206|<|0.0963|2-Sided|90.0|-6.99|0.3||Hochberg adjusted p-value|Mixed Models Analysis||||
1595071|NCT02969018|2932745|Other||Least Squares Mean Difference|-8.64|Standard Error of the Mean|2.232|<|0.0005|2-Sided|90.0|-12.33|-4.95||Hochberg adjusted p-value|Mixed Models Analysis||||
1595072|NCT02968979|2932762|Other||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.|
1595073|NCT02968979|2932762|Other||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.|
1595074|NCT02968979|2932762|Other||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.|
1595075|NCT02968979|2932762|Other||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.|
1595076|NCT02968979|2932762|Other||||||<|0.0482||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.|
1595077|NCT02968979|2932762|Other||||||<|0.1085|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.|
1595078|NCT02968979|2932762|Other||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.|
1595079|NCT02968979|2932762|Other||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.|
1595080|NCT02968979|2932762|Other||||||<|0.0001||||||Without refractory cachexia|Kruskal-Wallis|Without refractory cachexia||Statistical analysis compares all cachexia stages.|
1595081|NCT02968979|2932762|Other||||||<|0.0001|||||||Kruskal-Wallis|||Statistical analysis compares all cachexia stages.|
1595082|NCT02968979|2932772|Other|||||||0.0008|||||||Chi-squared|||"Statistical Analysis 2 for Frequency of the Different Stages of Cachexia, excluding the refractory cachexia stage, in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.~Statistical analysis applies to all rows and columns."|
1595083|NCT02968979|2932772|Other|||||||0.0032|||||||likelihood-ratio test|||Statistical analysis applies to all rows and columns.|
1595084|NCT02968914|2932785|Superiority||Geometric mean ratio (%)|92.34|||||2-Sided|90.0|86.34|98.75|||||||
1595085|NCT02968914|2932786|Superiority||Geometric mean ratio (%)|92.83|||||2-Sided|90.0|87.41|98.58|||||||
1595086|NCT02968914|2932787|Superiority||Geometric mean ratio (%)|94.46|||||2-Sided|90.0|88.16|101.21|||||||
1595087|NCT02968368|2932796|Superiority||Mean Difference (Final Values)|1.86|Standard Error of the Mean|0.708||0.0098|2-Sided|95.0|0.457|3.261|||ANCOVA||||
1595088|NCT02968368|2932797|Superiority||Mean Difference (Final Values)|4.46|Standard Error of the Mean|1.282||0.0007|2-Sided|95.0|1.928|7.001|||ANCOVA||||
1595089|NCT02968368|2932800|Superiority||Mean Difference (Final Values)|39.03|Standard Error of the Mean|11.097||0.0006|2-Sided|95.0|17.07|60.992|||ANCOVA||||
1595090|NCT02968368|2932805|Superiority||Mean Difference (Final Values)|0.52|Standard Error of the Mean|0.21||0.0149|2-Sided|95.0|0.102|0.93|||ANCOVA||||
1595091|NCT02967510|2932833|Superiority||LS Mean Difference|-0.4|||<|0.001|2-Sided|95.0|-0.5|-0.3|||ANCOVA||||
1595092|NCT02967510|2932833|Superiority||LS Mean Difference|-0.49|||<|0.001|2-Sided|95.0|-0.592|-0.383|||ANCOVA||||
1595093|NCT02967510|2932833|Superiority||LS Mean Difference|-0.47|||<|0.001|2-Sided|95.0|-0.575|-0.371|||ANCOVA||||
1595094|NCT02967510|2932834|Superiority||LS Mean Difference|0.34|||<|0.001|2-Sided|95.0|0.245|0.439|||ANCOVA||||
1595095|NCT02967510|2932834|Superiority||LS Mean Difference|0.39|||<|0.001|2-Sided|95.0|0.291|0.494|||ANCOVA||||
1595096|NCT02967510|2932834|Superiority||LS Mean Difference|0.44|||<|0.001|2-Sided|95.0|0.337|0.535|||ANCOVA||||
1595097|NCT02967510|2932835|Superiority||LS Mean Difference|-0.66|||<|0.001|2-Sided|95.0|-0.916|-0.397|||ANCOVA||||
1595098|NCT02967510|2932835|Superiority||LS Mean Difference|-0.75|||<|0.001|2-Sided|95.0|-1.013|-0.484|||ANCOVA||||
1595099|NCT02967510|2932835|Superiority||LS Mean Difference|-0.81|||<|0.001|2-Sided|95.0|-1.071|-0.548|||ANCOVA||||
1595100|NCT02967510|2932836|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595101|NCT02967510|2932836|Superiority||Median Difference (Final Values)|-1.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595102|NCT02967510|2932836|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595103|NCT02967510|2932837|Superiority||Median Difference (Final Values)|0.0|||<|0.001|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595104|NCT02967510|2932837|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595105|NCT02967510|2932837|Superiority||Median Difference (Final Values)|0.0|||<|0.001|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595106|NCT02967510|2932838|Superiority||Median Difference (Final Values)|0.0|||<|0.001|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595107|NCT02967510|2932838|Superiority||Median Difference (Final Values)|-1.0|||<|0.001|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595108|NCT02967510|2932838|Superiority||Median Difference (Final Values)|-1.0|||<|0.001|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595109|NCT02967510|2932839|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595110|NCT02967510|2932839|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595111|NCT02967510|2932839|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595112|NCT02967510|2932840|Superiority||Median Difference (Final Values)|0.0|||<|0.001|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595113|NCT02967510|2932840|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595114|NCT02967510|2932840|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595115|NCT02967510|2932841|Superiority||LS Mean Difference|-0.6|||=|0|2-Sided|95.0|-1.29|0.084|||ANCOVA||||
1595116|NCT02967510|2932841|Superiority||LS Mean Difference|-0.22|||=|0|2-Sided|95.0|-0.917|0.484|||ANCOVA||||
1595117|NCT02967510|2932841|Superiority||LS Mean Difference|-0.16|||=|0|2-Sided|95.0|-0.854|0.531|||ANCOVA||||
1595118|NCT02967510|2932842|Superiority||LS Mean Difference|-0.64|||=|0|2-Sided|95.0|-2.009|0.728|||ANCOVA||||
1595119|NCT02967510|2932842|Superiority||LS Mean Difference|0.87|||=|0|2-Sided|95.0|-0.611|2.361|||ANCOVA||||
1595120|NCT02967510|2932842|Superiority||LS Mean Difference|0.74|||=|0|2-Sided|95.0|-0.669|2.153|||ANCOVA||||
1595121|NCT02967510|2932843|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1598432|NCT02900378|2936703|Other|||||||0.6961|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8|
1595122|NCT02967510|2932843|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595123|NCT02967510|2932843|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595124|NCT02967510|2932844|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595125|NCT02967510|2932844|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595126|NCT02967510|2932844|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595127|NCT02967510|2932845|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595128|NCT02967510|2932845|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595129|NCT02967510|2932845|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595130|NCT02967510|2932846|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595131|NCT02967510|2932846|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|1.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595132|NCT02967510|2932846|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|1.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595133|NCT02967510|2932847|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595134|NCT02967510|2932847|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595135|NCT02967510|2932847|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595136|NCT02967510|2932848|Superiority||Median Difference (Final Values)|-1.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595137|NCT02967510|2932848|Superiority||Median Difference (Final Values)|-1.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595138|NCT02967510|2932848|Superiority||Median Difference (Final Values)|-1.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595139|NCT02967510|2932849|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595140|NCT02967510|2932849|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595141|NCT02967510|2932849|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595142|NCT02967510|2932850|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595143|NCT02967510|2932850|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595144|NCT02967510|2932850|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595145|NCT02967510|2932851|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595146|NCT02967510|2932851|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595147|NCT02967510|2932851|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595148|NCT02967510|2932852|Superiority||Median Difference (Final Values)|0.0|||<|0.001|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595149|NCT02967510|2932852|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595150|NCT02967510|2932852|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595151|NCT02967510|2932853|Superiority||LS Mean Difference|-0.48|||=|0|2-Sided|95.0|-1.111|0.16|||ANCOVA||||
1595152|NCT02967510|2932853|Superiority||LS Mean Difference|-0.51|||=|0|2-Sided|95.0|-1.158|0.137|||ANCOVA||||
1595153|NCT02967510|2932853|Superiority||LS Mean Difference|-0.56|||=|0|2-Sided|95.0|-1.204|0.079|||ANCOVA||||
1595154|NCT02967510|2932854|Superiority||LS Mean Difference|0.03|||=|0|2-Sided|95.0|-1.188|1.257|||ANCOVA||||
1595155|NCT02967510|2932854|Superiority||LS Mean Difference|-0.24|||=|0|2-Sided|95.0|-1.568|1.09|||ANCOVA||||
1595156|NCT02967510|2932854|Superiority||LS Mean Difference|0.24|||=|0|2-Sided|95.0|-1.0|1.487|||ANCOVA||||
1595157|NCT02967510|2932855|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1598433|NCT02900378|2936703|Other|||||||0.5547|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7|
1595158|NCT02967510|2932855|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595159|NCT02967510|2932855|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595160|NCT02967510|2932856|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595161|NCT02967510|2932856|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595162|NCT02967510|2932856|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595163|NCT02967510|2932857|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595164|NCT02967510|2932857|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595165|NCT02967510|2932857|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595166|NCT02967510|2932858|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595167|NCT02967510|2932858|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval
1595168|NCT02967510|2932858|Superiority||Mean Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595169|NCT02967510|2932859|Superiority||LS Mean Difference|-0.43|||<|0.001|2-Sided|95.0|-0.531|-0.331|||ANCOVA||||
1595170|NCT02967510|2932859|Superiority||LS Mean Difference|-0.47|||<|0.001|2-Sided|95.0|-0.572|-0.365|||ANCOVA||||
1595171|NCT02967510|2932859|Superiority||LS Mean Difference|-0.5|||<|0.001|2-Sided|95.0|-0.603|-0.4|||ANCOVA||||
1595172|NCT02967510|2932860|Superiority||LS Mean Difference|0.16|||<|0.001|2-Sided|95.0|0.097|0.226|||ANCOVA||||
1595173|NCT02967510|2932860|Superiority||LS Mean Difference|0.15|||<|0.001|2-Sided|95.0|0.078|0.213|||ANCOVA||||
1595174|NCT02967510|2932860|Superiority||LS Mean Difference|0.21|||<|0.001|2-Sided|95.0|0.147|0.278|||ANCOVA||||
1595175|NCT02967510|2932861|Superiority||LS Mean Difference|-0.66|||<|0.001|2-Sided|95.0|-0.951|-0.369|||ANCOVA||||
1595176|NCT02967510|2932861|Superiority||LS Mean Difference|-0.75|||<|0.001|2-Sided|95.0|-1.051|-0.458|||ANCOVA||||
1595177|NCT02967510|2932861|Superiority||LS Mean Difference|-0.74|||<|0.001|2-Sided|95.0|-1.031|-0.444|||ANCOVA||||
1595178|NCT02967510|2932862|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|0.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595179|NCT02967510|2932862|Superiority||Mean Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595265|NCT02962908|2933218|Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 42.|
1595180|NCT02967510|2932862|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-1.0|0.0||Hodges-Lehmann estimate (HLE) of median difference between treatments was calculated. Medians were not calculated per SAP as might cause confusion since the HLE of treatment difference is not identical to the difference between 2 treatment medians|Wilcoxon rank-sum test||Hodges-Lehmann estimate of location shift and corresponding asymptotic Confidence Interval||
1595181|NCT02967354|2932887|Superiority|||||||0.0048||||||Treshold for significance P<0.05|ANOVA||||
1595182|NCT02967354|2932888|Superiority|||||||0.9472||||||Treshold for significance P<0.05|ANOVA||||
1595183|NCT02967354|2932889|Superiority|||||||0.0072||||||Treshold for significance P<0.05|ANOVA||||
1595184|NCT02967354|2932890|Superiority|||||||0.0065||||||Treshold for significance P<0.05|ANOVA||||
1595185|NCT02967354|2932891|Superiority|||||||0.5875||||||Treshold for significance P<0.05|ANOVA||||
1595186|NCT02966002|2932930|Other|||||||0.25|||||||t-test, 2 sided||||
1595187|NCT02966002|2932931|Other|||||||0.18|||||||t-test, 2 sided||||
1595188|NCT02966002|2932932|Other|||||||0.67|||||||t-test, 2 sided||||
1595189|NCT02966002|2932933|Other|||||||0.96|||||||t-test, 2 sided||||
1595190|NCT02965924|2932935|Superiority||||||<|0.01|||||||t-test, 2 sided||||
1595191|NCT02965833|2932938|Superiority||||||=|0|||||||Mixed Models Analysis||||
1595192|NCT02965820|2932939|Superiority||||||=|0|||||||Mixed Models Analysis||||
1595193|NCT02965456|2932984|Superiority|||||||0.007||||||Threshold for significance at 0.05.|Regression, Logistic|||Analysis was performed using a logistic regression test (using Firth’s Penalized Likelihood) with factors of treatment group and analysis center.|
1595194|NCT02965456|2932985|Superiority||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using ANCOVA with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.|
1595195|NCT02965456|2932986|Superiority||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.|
1595196|NCT02964910|2932987|Other|The differences in incidence rate of ADR\AE between the two groups were compared.||||||0.956|||||||Chi-squared||||
1595197|NCT02964910|2932988|Other|The differences in incidence rate of ADR\AE between the two groups were compared.||||||0.614|||||||Chi-squared||||
1595198|NCT02964910|2932989|Other|The differences in incidence rate of ADR\AE between the two groups were compared.||||||0.949|||||||Chi-squared||||
1595199|NCT02964910|2932990|Other|The differences in incidence rate of ADR\AE between the two groups were compared.||||||0.728|||||||Chi-squared||||
1595200|NCT02964910|2932991|Other|The differences in incidence rate of ADR\AE between the two groups were compared.||||||0.778|||||||Chi-squared||||
1595201|NCT02964910|2932995|Non-Inferiority|The criteria of the immunogenicity non-inferiority between CHB group and healthy adults group were: the lower limit of 95%CI of the GMC ratio was not lower than 0.5.|GMC ratio|0.69|||||2-Sided|95.0|0.55|0.85|||||||
1595202|NCT02964910|2932996|Non-Inferiority|The criteria of the immunogenicity non-inferiority between CHB group and healthy adults group were: the lower limit of 95% CI of the seroconversion rate difference was not less than -10%.|the seroconversion rate difference(%)|-2.08|||||2-Sided|95.0|-5.23|0.22|||||||
1595203|NCT02964767|2932997|Other||||||<|0.049|||||||t-test, 2 sided||||
1595204|NCT02964338|2933011|Other||LS mean difference|-3.3||||0.3047|2-Sided|95.0|-9.59|3.01||Threshold for significance at 0.05 level.|ANCOVA||||
1595205|NCT02964338|2933011|Other||Least square (LS) mean difference|3.5||||0.2741|2-Sided|95.0|-2.8|9.82||Threshold for significance at 0.05 level.|ANCOVA||||
1595206|NCT02964312|2933017|Superiority||Proportion|89.5|||||2-Sided|95.0|83.5|93.9||||||The null hypothesis was that the proportion of responders at 6 months would be 50%. Since there was not direct comparison group, the hypothesis was set as a superiority comparison to a target proportion (66%) with a power level >90%.|
1595207|NCT02964247|2933042|Superiority|Test was not controlled for type I error. Secondary estimand: treatment effect (efficacy) based on the FAS using post baseline measurements up to and including week 26 from the on-treatment without rescue medication obs. period.|Treatment difference|-0.86|Standard Error of the Mean|0.46||0.062|2-Sided|95.0|-1.77|0.04|||Mixed Models Analysis||Liraglutide - Placebo|Statistical analysis for the secondary estimand. The change in body weight from baseline up to and including week 26 at scheduled time points were analysed using MMRM with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline body weight as covariate, all nested within visit.|
1595208|NCT02964247|2933042|Superiority||Treatment difference|-0.82|Standard Error of the Mean|0.46||0.077|2-Sided|95.0|-1.73|0.09|||pattern mixture model||Liraglutide - Placebo|Statistical analysis for the primary estimand. Primary estimand: treatment effect (effectiveness) based on the FAS using week 26 measurements from the in-trial observation period. The change in body weight from baseline to week 26 were analysed using a pattern mixture model with multiple imputation to impute missing data, with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline body weight as covariate.|
1595209|NCT02964247|2933043|Superiority|Test was not controlled for type I error. Secondary estimand: treatment effect (efficacy) based on the FAS using post baseline measurements up to and including week 26 from the on-treatment without rescue medication obs. period.|Treatment difference|-0.74|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.94|-0.53|||Mixed Models Analysis||Liraglutide - Placebo|Statistical analysis for the secondary estimand.The change in HbA1c from baseline up to and including week 26 at scheduled time points were analysed using MMRM with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline HbA1c as covariate, all nested within visit.|
1595226|NCT02963935|2933100|Other||Odds Ratio (OR)|2.74||||0.006|2-Sided|95.0|1.33|5.62|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.|
1620531|NCT02314923|2977569|Other||||||<|0.094|||||||ANOVA||||
1595210|NCT02964247|2933043|Superiority||Treatment difference|-0.68|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.89|-0.48|||pattern mixture model||Liraglutide - Placebo|Statistical analysis for the primary estimand. Primary estimand: treatment effect (effectiveness) based on the FAS using week 26 measurements from the in-trial observation period. The change in HbA1c from baseline to week 26 were analysed using a pattern mixture model with multiple imputation to impute missing data, with treatment, country and the stratification factor (metformin use at baseline: yes vs. no) as categorical fixed effects and baseline HbA1c as covariate.|
1595211|NCT02964234|2933044|Superiority||Odds Ratio (OR)|6.15|||<|0.0001|2-Sided|95.0|2.82|13.32||Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size.|Ordinal regression|||We used ordinal regression, given the non-normal distribution revealed by preliminary analyses. Analyses clustered by cohort and adjusted for age, SES (education, income, insurance), mammography history, mammography intention, and baseline supportive breast cancer social network size. Power analyses suggested that with 150 Latinas, alpha = .05, power = .80, we would be able to detect a small effect (Cohen's f = 0.05).|
1595212|NCT02964234|2933045|Superiority||Slope|-0.19||||0.03|2-Sided|95.0|-0.34|-0.04|||Regression, Linear|With GEE. Models had exchangeable correlation structure, a gamma distribution, and log link.||Analyses were conducted using GEE with an exchangeable correlation structure and a gamma distribution with log link. All models included study arm, time, and the study arm*time. Covariates included age, education, and mammography history. With 150 Latinas, alpha = 0.05, power = 0.80, ICC = 0.0-0.05, we expected to detect small/medium interaction effects.|
1595213|NCT02964234|2933046|Superiority||Odds Ratio (OR)|10.59||||0.005|2-Sided|95.0|2.01|56.31||We clustered by cohort, given both interventions used a group format, and adjusted for age, socioeconomic status (education, income, insurance status) baseline mammography history, and baseline mammography intention.|Regression, Logistic|||We conducted logistic regressions, clustering by cohort, given both interventions used a group format, and adjusting for age, education, income, insurance status, baseline mammography history, and baseline mammography intention. The null hypothesis was there would be no study arm differences. A priori power analysis suggested that a sample size of 150, assuming alpha = .05, power = .80 would lead us to detect medium/large effects (OR = 2.8).|
1595214|NCT02963987|2933050|Superiority||||||<|0.0001|||||||Mixed Models Analysis||||
1595215|NCT02963987|2933051|Superiority|||||||0.006|||||||Mixed Models Analysis||||
1595216|NCT02963987|2933052|Superiority||||||<|0.0001|||||||Mixed Models Analysis||||
1595217|NCT02963935|2933095|Other||Treatment difference|7.66||||0.37|2-Sided|95.0|-9.15|24.48|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.|
1595218|NCT02963935|2933095|Superiority|Superiority was not tested as part of confirmatory testing strategy.|Treatment difference|3.12||||0.6986|2-Sided|95.0|-12.68|18.92|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.|
1595219|NCT02963935|2933096|Other||treatment difference|1.25||||0.5572|2-Sided|95.0|-2.95|5.45|||Mixed models repeated measurements (MMRM||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.|
1595220|NCT02963935|2933096|Superiority|Superiority was not tested as part of confirmatory testing strategy.|Treatment difference|0.87||||0.6916|2-Sided|95.0|-3.41|5.14|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.|
1595221|NCT02963935|2933097|Other||Treatment difference|0.16||||0.8053|2-Sided|95.0|-1.12|1.43|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg- placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.|
1595222|NCT02963935|2933097|Superiority||Treatment difference|0.16||||0.8137|2-Sided|95.0|-1.19|1.52|||ANCOVA||Liraglutide 3.0 mg - placebo|Treatment policy estimand. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.|
1595223|NCT02963935|2933098|Other||Treatment difference|-3.45||||0.002|2-Sided|95.0|-5.62|-1.28|||Mixed model repeated measurements (MMRM)||Liraglutide 3.0 mg - placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate, all nested within visit.|
1595224|NCT02963935|2933098|Superiority||treatment difference|-2.72||||0.0063|2-Sided|95.0|-4.68|-0.77|||ANCOVA||Liraglutide 3.0 mg - placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline measurement of endpoint as covariate.|
1595225|NCT02963935|2933099|Superiority||Odds Ratio (OR)|3.32|||<|0.0001|2-Sided|95.0|1.93|5.72|||Regression, Logistic||Liraglutide 3.0 mg/placebo|"Treatment policy estimand. Week 16 responders were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.~Missing values are considered as non-responders."|
1595261|NCT02962908|2933215|Other|||||||0.168|||||||Fisher Exact|||Differences in the infection rates against any of the strains tested between treatment group and corresponding placebo.|
1595262|NCT02962908|2933215|Other|||||||0.662|||||||Fisher Exact|||Differences in the infection rates against any of the strains tested between treatment group and corresponding placebo.|
1595227|NCT02963935|2933100|Superiority||Odds Ratio (OR)|2.26||||0.0311|2-Sided|95.0|1.08|4.74|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.|
1595228|NCT02963935|2933101|Other||Odds Ratio (OR)|2.14||||0.0063|2-Sided|95.0|1.24|3.69|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.|
1595229|NCT02963935|2933101|Superiority||Odds Ratio (OR)|1.78||||0.0469|2-Sided|95.0|1.01|3.14|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x10000) imputation approach.|
1595230|NCT02963935|2933102|Other||Odds Ratio (OR)|2.84||||0|2-Sided|95.0|1.75|4.61|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg/placebo|Hypothetical estimand. Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.|
1595231|NCT02963935|2933102|Superiority||Odds Ratio (OR)|2.51||||0.0003|2-Sided|95.0|1.53|4.14|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Treatment policy estimand. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups, and sex as factors and baseline body weight as covariate. Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach.|
1595232|NCT02963935|2933103|Other|The hypothetical estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) for all randomised subjects assuming that all subjects remained on trial product (on-treatment principle)|Treatment difference|-4.59||||0|2-Sided|95.0|-6.54|-2.64|||Mixed models repeated measurement (MMRM)||Liraglutide 3.0 mg - placebo|Hypothetical estimand. Analysis of on-drug data before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups, and sex as factors and baseline body weight as covariate, all nested within visit.|
1595233|NCT02963935|2933103|Superiority|The treatment policy estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) at week 56 for all randomised subjects regardless of premature discontinuation of trial product.|Treatment difference|-3.45||||0.0003|2-Sided|95.0|-5.31|-1.59|||ANCOVA|Missing observations were imputed from the placebo arm based on a jump to reference (x100) multiple imputation approach.|Liraglutide 3.0 mg - placebo|Treatrment policy estimand. The hypothesis and the alternative are: H: μliraglutide ≥ μplacebo against the alternative HA: μliraglutide < μplacebo. μliraglutide and μplacebo denote the true mean of % weight change for liraglutide 3.0 mg and placebo group, respectively. Week 56 responses were analysed using an analysis of covariance model with treatment, BMI groups, and sex as factors and baseline body weight as covariate.|
1595234|NCT02963922|2933148|Superiority||Odds Ratio (OR)|4.73|||<|0.0001|2-Sided|95.0|3.04|7.36|||Mixed model for repeated measurements||Liraglutide 3.0 mg/Placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit. The MMRM was used to classify responders and analysed with a logistic regression with treatment as the only factor.|
1595235|NCT02963922|2933148|Superiority||Odds Ratio (OR)|3.41|||<|0.0001|2-Sided|95.0|2.19|5.31|||Regression, Logistic||Liraglutide 3.0 mg/Placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using a logistic regression model with treatment, BMI groups and sex as factors and baseline body weight as covariate.|
1595236|NCT02963922|2933149|Superiority|The hypothetical estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) for all randomised participants assuming that all participants remained on trial product (on-treatment principle).|Treatment difference|-5.1|Standard Error of the Mean|0.61|<|0.0001|2-Sided|95.0|-6.3|-3.91|||MMRM||Liraglutide 3.0 mg - placebo|Analysis of on-drug before first drug discontinuation date using a mixed model for repeated measurements with treatment, BMI groups and sex as factors and baseline body weight as covariate, all nested within visit.|
1595237|NCT02963922|2933149|Superiority|The treatment policy estimand evaluated the treatment effect (liraglutide 3.0 mg vs placebo) at week 56 for all randomised participants regardless of premature discontinuation of trial product.|Treatment difference|-4.32|Standard Error of the Mean|0.59|<|0.0001|2-Sided|95.0|-5.48|-3.16|||ANCOVA||Liraglutide 3.0 mg - placebo|Analysis of in-trial data with missing observations imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Week 56 responses were analysed using an analysis of covariance model with treatment, body mass index (BMI) groups and sex as factors and baseline body weight as covariate.|
1595238|NCT02963701|2933150|Equivalence|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|Ratio (%)|106.17|Standard Deviation|14.77|||2-Sided|90.0|101.3|111.26|||||The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).||
1595239|NCT02963701|2933151|Equivalence|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|86.53|Standard Deviation|16.85|||2-Sided|90.0|82.03|91.28|||||The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).||
1595263|NCT02962908|2933218|Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 180.|
1595264|NCT02962908|2933218|Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 180.|
1595240|NCT02963701|2933152|Equivalence|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|101.65|Standard Deviation|7.01|||2-Sided|90.0|99.4|103.95|||||The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).||
1595241|NCT02963701|2933153|Equivalence|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|101.86|Standard Deviation|7.89|||2-Sided|90.0|99.33|104.46|||||The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).||
1595242|NCT02963701|2933154|Equivalence|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|90.83|Standard Deviation|21.49|||2-Sided|90.0|84.87|97.21|||||The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).||
1595243|NCT02963701|2933155|Equivalence|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|96.12|Standard Deviation|14.06|||2-Sided|90.0|91.92|100.51|||||The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).||
1595244|NCT02963701|2933156|Equivalence|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|95.96|Standard Deviation|14.27|||2-Sided|90.0|91.7|100.4|||||The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).||
1595245|NCT02963701|2933157|Equivalence|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|99.67|Standard Deviation|13.5|||2-Sided|90.0|95.48|104.04|||||The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).||
1595246|NCT02963701|2933158|Equivalence|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|98.97|Standard Deviation|8.13|||2-Sided|90.0|96.44|101.57|||||The estimated parameter was the adjusted geometric mean ratios (%)of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).||
1595247|NCT02963701|2933159|Equivalence|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|102.16|Standard Deviation|15.37|||2-Sided|90.0|97.3|107.27|||||The estimated parameter was the adjusted geometric mean ratios [%] of Test and Reference products. The parameter dispersion type [SD] was actually the intra-individual geometric coefficient of variation [%].||
1595248|NCT02963701|2933160|Equivalence|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%.|T/R Ratio (%)|99.75|Standard Deviation|12.96|||2-Sided|90.0|95.73|103.95|||||The estimated parameter was the adjusted geometric mean ratios [%] of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation [%].||
1595249|NCT02963701|2933161|Equivalence|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%|T/R Ratio (%)|89.16|Standard Deviation|19.28|||2-Sided|90.0|83.88|94.76|||||The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).||
1595250|NCT02963701|2933162|Equivalence|A claim of bioequivalence was made if the 90% confidence interval (CI) of the geometric means of T/R ratio was contained in the pre-defined acceptance range of 80.00% to 125.00%|T/R Ratio (%)|99.16|Standard Deviation|8.49|||2-Sided|90.0|96.52|101.89|||||The estimated parameter was the adjusted geometric mean ratios (%) of Test and Reference products. The parameter dispersion type (Standard Deviation) was actually the intra-individual geometric coefficient of variation (%).||
1595251|NCT02962908|2933213|Other|||||||0.201|||||||Wilcoxon (Mann-Whitney)|||Comparison of the average symptom score between treatment group and corresponding placebo.|
1595252|NCT02962908|2933213|Other|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||Comparison of the average symptom score between treatment group and corresponding placebo.|
1595253|NCT02962908|2933213|Other|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Comparison of the symptom peak between treatment group and corresponding placebo.|
1595254|NCT02962908|2933213|Other|||||||0.658|||||||Wilcoxon (Mann-Whitney)|||Comparison of the symptom peak between treatment group and corresponding placebo.|
1595255|NCT02962908|2933213|Other|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Comparison of the total symptom score between treatment group and corresponding placebo.|
1595256|NCT02962908|2933213|Other|||||||0.513|||||||Wilcoxon (Mann-Whitney)|||Comparison of total symptom score between treatment group and corresponding placebo.|
1595257|NCT02962908|2933213|Other|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||Comparison of the duration of symptoms between treatment group and corresponding placebo.|
1595258|NCT02962908|2933213|Other|||||||0.513|||||||Wilcoxon (Mann-Whitney)|||Comparison in the duration of symptoms between treatment group and corresponding placebo.|
1595259|NCT02962908|2933214|Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||Study not powered to detect statistically significant differences
1595260|NCT02962908|2933214|Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||The study was not powered to detected statistical significant differences in this outcome.
1595266|NCT02962908|2933218|Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison of geometric mean IgG titers specific to FLU-v antigens on day 42 post-vaccination.|
1595267|NCT02962908|2933221|Other||||||<|0.001|||||||Fisher Exact|||"Comparison of number of responders on day 180. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 180."|
1595268|NCT02962908|2933221|Other||||||<|0.399|||||||Chi-squared|||"Comparison of number of responders on day 180. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 180."|
1595269|NCT02962908|2933221|Other||||||<|0.001|||||||Fisher Exact|||"Comparison of number of responders on day 42. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 42."|
1595270|NCT02962908|2933221|Other||||||<|0.113|||||||Chi-squared|||"Comparison of number of responders on day 42. A subject was considered a responder if an increase of secreted IFNgamma of at least two fold was observed from day 0 to day 42."|
1595271|NCT02962908|2933222|Other||||||<|0.001|||||||Chi-squared|||Comparison of IL-2 responders on day 180. Differences considered significant if p-value <0.05.|
1595272|NCT02962908|2933222|Other||||||<|1|||||||Fisher Exact|||Comparison of IL-2 responders on day 180. Differences considered significant if p-value <0.05.|
1595273|NCT02962908|2933222|Other||||||<|0.013|||||||Fisher Exact|||Comparison of TNF alpha responders on day 180. Differences considered significant if p-value <0.05.|
1595274|NCT02962908|2933222|Other||||||<|1|||||||Fisher Exact|||Comparison of TNF alpha responders on day 180. Differences considered significant if p-value <0.05.|
1595275|NCT02962908|2933222|Other||||||<|0.001|||||||Chi-squared|||Comparison of IFNgamma responders on day 180.Differences considered significant if p-value <0.05.|
1595276|NCT02962908|2933222|Other||||||<|0.483|||||||Fisher Exact|||Comparison of IFNgamma responders on day 180. Differences considered significant if p-value <0.05.|
1595277|NCT02962908|2933222|Other||||||<|0.001|||||||Chi-squared|||Comparison of IL-2 responders on day 42. Differences considered significant if p-value <0.05.|
1595278|NCT02962908|2933222|Other||||||<|1|||||||Fisher Exact|||Comparison of IL-2 responders on day 42. Differences considered significant if p-value <0.05.|
1595279|NCT02962908|2933222|Other||||||<|0.001|||||||Chi-squared|||Comparison of TNF alpha responders on day 42. Differences considered significant if p-value <0.05.|
1595280|NCT02962908|2933222|Other||||||<|1|||||||Fisher Exact|||Comparison of TNF alpha responders on day 42. Differences considered significant if p-value <0.05.|
1595281|NCT02962908|2933222|Other||||||<|0.001|||||||Chi-squared|||Comparison of IFNgamma responders on day 42. Differences considered significant if p-value <0.05.|
1595282|NCT02962908|2933222|Other||||||<|0.249|||||||Cochran-Mantel-Haenszel|||Comparison of IFNgamma responders on day 42. Differences considered significant if p-value <0.05.|
1595283|NCT02962284|2933252|Superiority||||||>|0.1|||||||ANCOVA||||
1595284|NCT02961790|2933257|Superiority|||||||0.0025|||||||Kruskal-Wallis||||
1595285|NCT02961790|2933257|Superiority|||||||0.0011|||||||Kruskal-Wallis||||
1595286|NCT02961790|2933258|Superiority|||||||0.0279|||||||Kruskal-Wallis||||
1595287|NCT02961790|2933258|Superiority|||||||0.0174|||||||Kruskal-Wallis||||
1595288|NCT02961790|2933259|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Adjusted for effects specified in outcome measure description.|||
1595289|NCT02961790|2933260|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Adjusted for effects specified in outcome measure description.|||
1595290|NCT02961790|2933261|Superiority|||||||0.0001|||||||Kruskal-Wallis||||
1595291|NCT02961790|2933261|Superiority|||||||0.0041|||||||Kruskal-Wallis||||
1595292|NCT02961764|2933292|Superiority|||||||0.002|||||||t-test, 1 sided||||
1595293|NCT02961764|2933294|Superiority|||||||0.05|||||||t-test, 1 sided||||
1595294|NCT02961764|2933295|Superiority|||||||0.005|||||||t-test, 1 sided||||
1595295|NCT02961764|2933296|Superiority||Odds Ratio (OR)|0.289|||<|0.001|2-Sided|95.0|0.156|0.532|||Fisher Exact||||
1595296|NCT02961062|2933310|Superiority||Median Difference (Final Values)|-8.56|Standard Error of the Mean|3.37||0.017|2-Sided|90.0|-14.29|-2.83|||Kenward-Roger method||||
1595297|NCT02961062|2933311|Superiority||Mean Difference (Final Values)|-11.1|Standard Error of the Mean|0.0||0.005|2-Sided|90.0|-17.54|-4.71|||Kenward-Roger method||||
1595298|NCT02960295|2933337|Other||||||<|0.05|||||||Pearson correlation coefficient (r)||||
1595299|NCT02960295|2933337|Other|This is an observational study|||||<|0.05|||||||Pearson correlation coefficient (r)||||
1595300|NCT02960295|2933337|Other|This is an observational study|||||<|0.05|||||||Pearson correlation (r)||||
1595301|NCT02960295|2933338|Other|There was no comparison group and no test of statistical significance.||||||||||||||||In this interventional study the number of glucose checks per patient per day was calculated as stated above. There was no comparison group and no test of statistical significance.|This is a simple calculation of the mean (sd) of the number of glucose checks per pt per day
1595302|NCT02960217|2933339|Superiority|||||||0.6918|||||||Wilk-Shapiro Test for Normality||||
1595303|NCT02960217|2933339|Superiority||LS Mean Difference|-1.0|Standard Error of the Mean|1.51||0.5233|2-Sided|95.0|-4.4|2.4||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA||||
1595304|NCT02960217|2933340|Superiority||Hodges-Lehmann estimate (Median Diff.)|2.0||||0.3907|2-Sided|95.0|-3.5|20.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=13).|
1595305|NCT02960217|2933340|Superiority|||||||0.0138|||||||Wilk-Shapiro Test for Normality||||
1595306|NCT02960217|2933341|Superiority|||||||0.7698|||||||Wilk-Shapiro Test for Normality||||
1595307|NCT02960217|2933341|Superiority||LS Mean Difference|1.0|Standard Error of the Mean|0.54||0.1076|2-Sided|95.0|-0.3|2.2||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA||||
1595308|NCT02960217|2933342|Superiority||Hodges-Lehmann estimate (Median Diff.)|0.0||||1|2-Sided|95.0|-14.5|13.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=12).|
1595309|NCT02960217|2933342|Superiority|||||||0.0072|||||||Wilk-Shapiro Test for Normality||||
1595310|NCT02960217|2933343|Superiority||Hodges-Lehmann estimate (Median Diff.)|-0.5||||0.2425|2-Sided|95.0|-1.5|0.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=13).|
1595311|NCT02960217|2933343|Superiority|||||||0.0315|||||||Wilk-Shapiro Test for Normality||||
1595312|NCT02960217|2933345|Superiority|||||||0.2348|||||||Wilk-Shapiro Test for Normality||||
1595313|NCT02960217|2933345|Superiority||LS Mean Difference|-0.1|Standard Error of the Mean|0.28||0.8329|2-Sided|95.0|-0.6|0.5||Based on an ANCOVA model including covariate for study baseline CGI-S score, fixed effects for treatment sequence, treatment group, period, and a random effect for subject within the sequence.|ANCOVA||||
1595314|NCT02960217|2933346|Superiority|||||||0.7267|||||||Wilk-Shapiro Test for Normality||||
1595315|NCT02960217|2933346|Superiority||LS Mean Difference|2.0|Standard Error of the Mean|1.09||0.0935|2-Sided|95.0|-0.4|4.5||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA||||
1595316|NCT02960217|2933347|Superiority|||||||0.6557|||||||Wilk-Shapiro Test for Normality||||
1595317|NCT02960217|2933347|Superiority||LS Mean Difference|1.5|Standard Error of the Mean|1.82||0.4176|2-Sided|95.0|-2.5|5.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA||||
1595318|NCT02960217|2933348|Superiority|||||||0.8255|||||||Wilk-Shapiro Test for Normality||||
1595319|NCT02960217|2933348|Superiority||LS Mean Difference|-1.2|Standard Error of the Mean|3.27||0.7145|2-Sided|95.0|-8.5|6.1|||ANCOVA||||
1595320|NCT02960217|2933349|Superiority|||||||0.1104|||||||Wilk-Shapiro Test for Normality||||
1595321|NCT02960217|2933349|Superiority||LS Mean Difference|-1.7|Standard Error of the Mean|2.84||0.5544|2-Sided|95.0|-8.1|4.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA||||
1595322|NCT02960217|2933350|Superiority|||||||0.4459|||||||Wilk-Shapiro Test for Normality||||
1595323|NCT02960217|2933350|Superiority||LS Mean Difference|-1.0|Standard Error of the Mean|1.62||0.5505|2-Sided|95.0|-4.6|2.6||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA||||
1595324|NCT02960217|2933351|Superiority|||||||0.1478|||||||Wilk-Shapiro Test for Normality||||
1595325|NCT02960217|2933351|Superiority||LS Mean Difference|2.6|Standard Error of the Mean|1.56||0.1138|2-Sided|95.0|-0.7|5.9||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA||||
1595326|NCT02960217|2933352|Superiority|||||||0.2034|||||||Wilk-Shapiro Test for Normality||||
1595327|NCT02960217|2933352|Superiority||LS Mean Difference|-1.8|Standard Error of the Mean|1.33||0.1875|2-Sided|95.0|-4.6|1.0||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA||||
1595328|NCT02960217|2933353|Superiority|||||||0.1066|||||||Wilk-Shapiro Test for Normality||||
1595329|NCT02960217|2933353|Superiority||LS Mean Difference|0.8|Standard Error of the Mean|1.42||0.5853|2-Sided|95.0|-2.2|3.8||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA||||
1595330|NCT02960217|2933354|Superiority||Hodges-Lehmann estimate (Median Diff.)|0.2||||0.4898|2-Sided|95.0|-5.4|5.8||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=21).|
1595331|NCT02960217|2933354|Superiority|||||||0.0005|||||||Wilk-Shapiro Test for Normality||||
1595332|NCT02960217|2933355|Superiority|||||||0.2894|||||||Wilk-Shapiro Test for Normality||||
1595333|NCT02960217|2933355|Superiority||LS Mean Difference|-0.4|Standard Error of the Mean|1.66||0.8345|2-Sided|95.0|-3.8|3.1||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA||||
1595334|NCT02960217|2933356|Superiority|||||||0.8451|||||||Wilk-Shapiro Test for Normality||||
1595335|NCT02960217|2933356|Superiority||LS Mean Difference|2.0|Standard Error of the Mean|1.32||0.1572|2-Sided|95.0|-0.8|4.7||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA||||
1595336|NCT02960217|2933357|Superiority|||||||0.8214|||||||Wilk-Shapiro Test for Normality||||
1595337|NCT02960217|2933357|Superiority||LS Mean Difference|-0.1|Standard Error of the Mean|0.91||0.9513|2-Sided|95.0|-2.0|1.9||Based on an ANCOVA model including covariate for period baseline value, fixed effects for treatment sequence, treatment group, period, and a random effect for participant within the sequence.|ANCOVA||||
1595338|NCT02960217|2933358|Superiority|||||||0.0005|||||||Wilk-Shapiro Test for Normality||||
1595339|NCT02960217|2933358|Superiority||Hodges-Lehmann estimate (Median Diff.)|25.0||||0.6419|2-Sided|95.0|-62.5|91.5||Hodges-Lehmann estimate of the location shift with 95% CI and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Number of participants in this analysis completed both UX007 treatment period and placebo treatment period (n=34).|
1620532|NCT02314923|2977569|Other||||||<|0.001|||||||ANOVA||||
1595341|NCT02960217|2933361|Superiority||Hodges-Lehmann estimate (Median Diff.)|1.46|||<|0.2684|2-Sided|95.0|-1.12|4.36||Hodges-Lehmann estimate of the location shift with 95% confidence interval (CI) and Wilcoxon Rank Sum test p-value are based on Wilcoxon rank-sum test.|Wilcoxon Rank Sum test|||Participants completing both UX007 treatment period and placebo period (n=42). Per protocol, when the normality assumption is not met (p value for Wilk-Shapiro test < 0.05), Wilcoxon rank-sum test will be considered as the primary analysis to assess treatment difference in movement disorder event frequency.|
1595342|NCT02959996|2933368|Superiority|||||||0.54|||||||Wilcoxon (Mann-Whitney)||||
1595343|NCT02959996|2933369|Superiority|||||||0.14|||||||Wilcoxon (Mann-Whitney)||||
1595344|NCT02959996|2933370|Superiority|||||||0.72|||||||Wilcoxon (Mann-Whitney)||||
1595345|NCT02959983|2933371|Superiority|||||||0.0018|||||||Chi-squared|||Weeks 9 to 12|
1595346|NCT02959983|2933371|Superiority|||||||0.0063|||||||Chi-squared|||Weeks 5 to 8|
1595347|NCT02959983|2933371|Superiority|||||||0.033|||||||Chi-squared|||Weeks 1-4|
1595348|NCT02959983|2933372|Superiority|||||||0.0619|||||||Chi-squared|||Weeks 9 to 12|
1595349|NCT02959983|2933372|Superiority|||||||0.0052|||||||Chi-squared|||Weeks 5 to 8|
1595350|NCT02959983|2933372|Superiority|||||||0.3832|||||||Chi-squared|||Weeks 1 to 4|
1595351|NCT02959983|2933372|Superiority|||||||0.0174|||||||Chi-squared|||Overall Weeks 1 to 12|
1595352|NCT02959983|2933373|Superiority|||||||0.37|||||||Chi-squared|||Weeks 9 to 12|
1595353|NCT02959983|2933373|Superiority|||||||0.0207|||||||Chi-squared|||Weeks 5 to 8|
1595354|NCT02959983|2933373|Superiority|||||||0.0048|||||||Chi-squared|||Weeks 1 to 4|
1595355|NCT02959983|2933373|Superiority|||||||0.0119|||||||Chi-squared|||Overall Weeks 1 to 12|
1595356|NCT02959983|2933374|Superiority|||||||0.0022|||||||Chi-squared|||Overall Weeks 1-12|
1595357|NCT02959840|2933404|Equivalence|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.7|||||||Fisher Exact||||
1595358|NCT02959840|2933404|Equivalence|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.5|||||||Fisher Exact||||
1595359|NCT02959840|2933404|Equivalence|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.2|||||||Fisher Exact||||
1595360|NCT02959840|2933405|Equivalence|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.3|||||||Fisher Exact||||
1595361|NCT02959840|2933405|Equivalence|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.2|||||||Fisher Exact||||
1595362|NCT02959840|2933405|Superiority|Our null hypothesis is that there is no statistically significant difference between the mean satisfaction level in the above 2 groups.||||||0.02|||||||Fisher Exact||||
1595363|NCT02959840|2933406|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared||||
1595364|NCT02959840|2933406|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||1|||||||Chi-squared||||
1595365|NCT02959840|2933406|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared||||
1595366|NCT02959840|2933407|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.7|||||||Chi-squared||||
1595367|NCT02959840|2933407|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.5|||||||Chi-squared||||
1595368|NCT02959840|2933407|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.2|||||||Chi-squared||||
1595369|NCT02959840|2933408|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.6|||||||Chi-squared||||
1595370|NCT02959840|2933408|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.07|||||||Chi-squared||||
1595371|NCT02959840|2933408|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.008|||||||Chi-squared||||
1595372|NCT02959840|2933409|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||1|||||||Chi-squared||||
1595373|NCT02959840|2933409|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.0004|||||||Chi-squared||||
1595374|NCT02959840|2933409|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.001|||||||Chi-squared||||
1595375|NCT02959840|2933410|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared||||
1595376|NCT02959840|2933410|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.2|||||||Chi-squared||||
1595377|NCT02959840|2933410|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||1|||||||Chi-squared||||
1595378|NCT02959840|2933411|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.2|||||||Chi-squared||||
1620533|NCT02314923|2977569|Other||||||<|0.286|||||||ANOVA||||
1595379|NCT02959840|2933411|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared||||
1595380|NCT02959840|2933411|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared||||
1595381|NCT02959840|2933412|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.7|||||||Chi-squared||||
1595382|NCT02959840|2933412|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.07|||||||Chi-squared||||
1595383|NCT02959840|2933412|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared||||
1595384|NCT02959840|2933413|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.09|||||||Chi-squared||||
1595385|NCT02959840|2933413|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.0004|||||||Chi-squared||||
1595386|NCT02959840|2933413|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||4e-05|||||||Chi-squared||||
1595387|NCT02959840|2933414|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.8|||||||Chi-squared||||
1595388|NCT02959840|2933414|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.0002|||||||Chi-squared||||
1595389|NCT02959840|2933414|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced vomiting in the above 2 groups.||||||0.001|||||||Chi-squared||||
1595390|NCT02959840|2933415|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||0.1|||||||Chi-squared||||
1595391|NCT02959840|2933415|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.||||||5e-05|||||||Chi-squared||||
1595392|NCT02959840|2933415|Equivalence|Our null hypothesis is that there is no statistically significant difference between the number of people who experienced nausea in the above 2 groups.|||||<|1e-05|||||||Chi-squared||||
1595393|NCT02959177|2933454|Superiority||LSMean Difference|-2.97|||<|0.001|2-Sided|95.0|-6.08|0.14|||Mixed Models Analysis||||
1595394|NCT02959177|2933454|Superiority||LSMean Difference|-4.9|||<|0.001|2-Sided|95.0|-8.06|-1.73|||Mixed Models Analysis||||
1595395|NCT02959177|2933455|Superiority||LSMean difference|-13.73|||<|0.001|2-Sided|95.0|-18.05|-9.4|||Mixed Models Analysis||||
1595396|NCT02959177|2933455|Superiority||LSMean Difference|-11.82|||<|0.001|2-Sided|95.0|-16.14|-7.51|||Mixed Models Analysis||||
1595397|NCT02959177|2933457|Superiority||LSMean difference|-2.7|||<|0.001|2-Sided|95.0|-3.41|-1.99|||Mixed Models Analysis||||
1595398|NCT02959177|2933457|Superiority||LSMean difference|-2.9|||<|0.001|2-Sided|95.0|-3.61|-2.19|||Mixed Models Analysis||||
1595399|NCT02959177|2933458|Superiority||Mean Difference (Final Values)|5.79|||<|0.01|2-Sided|95.0|3.33|8.24|||Mixed Models Analysis||||
1595400|NCT02959177|2933458|Superiority||LSMean difference|7.0|||<|0.001|2-Sided|95.0|4.54|9.46|||Mixed Models Analysis||||
1595401|NCT02959177|2933459|Superiority||Odds Ratio (OR)|3.13|||||2-Sided|95.0|1.79|5.44|||||||
1595402|NCT02959177|2933459|Superiority||Odds Ratio (OR)|3.47|||||2-Sided|95.0|2.03|5.93|||||||
1595403|NCT02959177|2933460|Superiority||Odds Ratio (OR)|3.16|||||2-Sided|95.0|2.08|4.8|||||||
1595404|NCT02959177|2933460|Superiority||Odds Ratio (OR)|3.24|||||2-Sided|95.0|2.14|4.89|||||||
1595405|NCT02959177|2933461|Superiority||Odds Ratio (OR)|3.664|||||2-Sided|95.0|2.54|5.23|||||||
1595406|NCT02959177|2933461|Superiority||Odds Ratio (OR)|3.89|||||2-Sided|95.0|2.71|5.57|||||||
1595407|NCT02959177|2933462|Superiority||Mean Difference (Final Values)|-2.7|||<|0.001|2-Sided|95.0|-3.53|-1.94|||Mixed Models Analysis||||
1595408|NCT02959177|2933462|Superiority||LSMean Difference|-3.01|||<|0.001|2-Sided|95.0|-3.8|-2.22|||Mixed Models Analysis||||
1595409|NCT02959138|2933465|Other|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|87.8|||||2-Sided|90.0|68.14|113.13||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.|
1595410|NCT02959138|2933465|Other|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|102.0|||||2-Sided|90.0|81.42|127.79||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.|
1595411|NCT02959138|2933466|Other|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|107.69|||||2-Sided|90.0|79.63|145.65||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.|
1595412|NCT02959138|2933466|Other|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|111.92|||||2-Sided|90.0|86.92|144.12||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.|
1595413|NCT02959138|2933467|Other|The test-to-reference ratio GLSM ratio and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|107.04|||||2-Sided|90.0|78.47|146.02||||||The Estimate statement was used to produce the point estimate and the corresponding 90% CI of the difference in PK parameters of interest on a logarithmic scale.|
1595414|NCT02959138|2933467|Other|The test-to-reference ratio (geometric least squares mean (GLSM) ratio) and associated 90% CI were calculated by taking the exponential of the point estimate and the corresponding lower and upper limits, which was consistent with the two 1-sided tests approach.|GLSM ratio|111.68|||||2-Sided|90.0|86.94|143.47||||||The Estimate statement was used to produce the point estimate and the corresponding 90% confidence interval of the difference in PK parameters of interest on a logarithmic scale.|
1595415|NCT02956746|2933576|Other|||||||0.4187||||||threshold for significance p-values < 0.05|ANOVA||||
1595416|NCT02954848|2933632|Superiority||Wilcoxon Rank-Sum Test|-0.44||||0.3778|2-Sided|95.0|-1.57|0.69|||Wilcoxon Rank-Sum Test|||Statistical analysis for not improved response|
1595417|NCT02954848|2933632|Superiority||Median Difference (Final Values)|-0.17||||0.1488|2-Sided|95.0|-0.42|0.04|||Wilcoxon Rank-Sum Test|||Statistical analysis for improved response|
1595418|NCT02954848|2933633|Superiority|||||||0.0288|||||||Log Rank||||
1595419|NCT02954848|2933634|Superiority|||||||0.0811|||||||Log Rank||||
1595420|NCT02954848|2933635|Superiority||Wilcoxon Rank-Sum Test|25.6||||0.2337|2-Sided|95.0|-19.2|75.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for not improved response|
1595421|NCT02954848|2933635|Superiority||Median Difference (Final Values)|5.5||||0.1885|2-Sided|95.0|-2.7|14.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for improved response|
1595422|NCT02954848|2933636|Superiority||Median Difference (Final Values)|0.13||||0.2367|2-Sided|95.0|-0.09|0.32|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and not improved|
1595423|NCT02954848|2933636|Superiority||Median Difference (Final Values)|-0.08||||0.2475|2-Sided|95.0|-0.24|0.07|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and improved response|
1595424|NCT02954848|2933636|Superiority||Median Difference (Final Values)|0.31||||0.165|2-Sided|95.0|-0.16|0.71|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and not improved response|
1595425|NCT02954848|2933636|Superiority||Median Difference (Final Values)|-0.29||||0.0095|2-Sided|95.0|-0.53|-0.07|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and improved response|
1595426|NCT02954848|2933636|Superiority||Median Difference (Final Values)|0.06||||0.4673|2-Sided|95.0|-0.1|0.22|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and not improved response|
1595427|NCT02954848|2933636|Superiority||Median Difference (Final Values)|-0.15||||0.02|2-Sided|95.0|-0.29|-0.02|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and improved response|
1595428|NCT02954848|2933636|Superiority||Wilcoxon Rank-Sum Test|-0.11||||0.4456|2-Sided|95.0|-0.33|0.17|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and not improved response|
1595429|NCT02954848|2933636|Superiority||Median Difference (Final Values)|-0.03||||0.7845|2-Sided|95.0|-0.23|0.16|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and improved response|
1595430|NCT02954848|2933637|Superiority|||||||0.7505|||||||Log Rank||||
1595431|NCT02954848|2933638|Superiority|||||||0.0175|||||||Log Rank||||
1595432|NCT02954848|2933639|Superiority|||||||0.552|||||||Log Rank||||
1595433|NCT02954848|2933640|Superiority|||||||0.0059|||||||Log Rank||||
1595434|NCT02954848|2933641|Superiority|||||||0.7999|||||||Log Rank||||
1595435|NCT02954848|2933642|Superiority|||||||0.0004|||||||Log Rank||||
1595436|NCT02954848|2933643|Superiority|||||||0.0125|||||||Log Rank||||
1595437|NCT02954848|2933644|Superiority|||||||0.997|||||||Log Rank||||
1595438|NCT02954848|2933645|Superiority||Median Difference (Final Values)|-3.3||||0.2613|2-Sided|95.0|-14.3|0.2|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and not improved response|
1595439|NCT02954848|2933645|Superiority||Median Difference (Final Values)|3.6||||0.1032|2-Sided|95.0|0.0|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade M and improved response|
1595440|NCT02954848|2933645|Superiority||Median Difference (Final Values)|-13.0||||0.16|2-Sided|95.0|-35.7|3.6|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and not improved response|
1595441|NCT02954848|2933645|Superiority||Median Difference (Final Values)|7.4||||0.0376|2-Sided|95.0|0.0|17.8|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 2, Grade N and improved response|
1595442|NCT02954848|2933645|Superiority||Median Difference (Final Values)|-0.7||||0.6452|2-Sided|95.0|-9.4|6.4|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and not improved response|
1595443|NCT02954848|2933645|Superiority||Median Difference (Final Values)|3.7||||0.0042|2-Sided|95.0|0.0|8.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade M and improved response|
1595444|NCT02954848|2933645|Superiority||Median Difference (Final Values)|3.2||||0.5627|2-Sided|95.0|-7.1|13.9|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and not improved response|
1595445|NCT02954848|2933645|Superiority||Median Difference (Final Values)|0.0||||0.6631|2-Sided|95.0|-5.0|3.5|||Wilcoxon Rank-Sum Test|||Statistical analysis for Criteria 1, Grade N and improved response|
1595446|NCT02954848|2933646|Superiority||Median Difference (Final Values)|-0.07||||0.3837|2-Sided|95.0|-0.22|0.09|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade M of endoscopic findings|
1595447|NCT02954848|2933646|Superiority||Median Difference (Final Values)|-0.18||||0.0757|2-Sided|95.0|-0.43|0.02|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade N of endoscopic findings|
1595448|NCT02954848|2933647|Superiority|||||||0.0153|||||||Log Rank||||
1595449|NCT02954848|2933648|Superiority|||||||0.0059|||||||Log Rank||||
1595450|NCT02954848|2933649|Superiority||Median Difference (Final Values)|3.6||||0.2146|2-Sided|95.0|-1.4|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade M of endoscopic findings|
1595451|NCT02954848|2933649|Superiority||Median Difference (Final Values)|6.5||||0.149|2-Sided|95.0|-1.9|15.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for Grade N of endoscopic findings|
1620534|NCT02314923|2977569|Other||||||<|0.001|||||||ANOVA||||
1595452|NCT02954848|2933650|Superiority||Median Difference (Final Values)|0.17||||0.0765|2-Sided|95.0|-0.01|0.36|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, not improved response|
1595453|NCT02954848|2933650|Superiority||Median Difference (Final Values)|-0.15||||0.0129|2-Sided|95.0|-0.28|-0.03|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, improved response|
1595454|NCT02954848|2933650|Superiority||Median Difference (Final Values)|0.02||||0.8138|2-Sided|95.0|-0.12|0.15|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, not improved response|
1595455|NCT02954848|2933650|Superiority||Median Difference (Final Values)|-0.1||||0.0505|2-Sided|95.0|-0.21|0.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, improved response|
1595456|NCT02954848|2933651|Superiority|||||||0.5393|||||||Log Rank||||
1595457|NCT02954848|2933652|Superiority|||||||0.0004|||||||Log Rank||||
1595458|NCT02954848|2933653|Superiority|||||||0.1059|||||||Log Rank||||
1595459|NCT02954848|2933654|Superiority|||||||0.0025|||||||Log Rank||||
1595460|NCT02954848|2933655|Superiority||Median Difference (Final Values)|-4.7||||0.0871|2-Sided|95.0|-17.4|0.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, not improved response|
1595461|NCT02954848|2933655|Superiority||Median Difference (Final Values)|5.2||||0.012|2-Sided|95.0|0.0|10.7|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 2, improved response|
1595462|NCT02954848|2933655|Superiority||Median Difference (Final Values)|0.0||||0.8963|2-Sided|95.0|-6.1|6.0|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, not improved response|
1595463|NCT02954848|2933655|Superiority||Median Difference (Final Values)|3.3||||0.0478|2-Sided|95.0|0.0|5.3|||Wilcoxon Rank-Sum Test|||Statistical analysis for criteria 1, improved response|
1595464|NCT02954848|2933656|Superiority||Median Difference (Final Values)|-0.11||||0.0826|2-Sided|95.0|-0.24|0.01|||Wilcoxon Rank-Sum Test||||
1595465|NCT02954848|2933657|Superiority|||||||0.0003|||||||Log Rank||||
1595466|NCT02954848|2933658|Superiority||Median Difference (Final Values)|3.8||||0.0643|2-Sided|95.0|0.0|10.6|||Wilcoxon Rank-Sum Test||The point estimate of the median difference between the treatment groups was calculated using the Hodges-Lehmann estimation.||
1595467|NCT02954601|2933690|Other|||||||0.3061|||||||Mixed Models Analysis|||Values obtained using a Mixed Model Repeated Measures Analysis of Variance with an unstructured covariance matrix. Treatment period and Baseline value (for change and percent change) are factors in the model with repeated values for subject.|
1595468|NCT02954601|2933693|Other|Values obtained using a Mixed Model Repeated Measures Analysis of Variance with an unstructured covariance matrix. Treatment, Period and Baseline value (for change and percent change) are factors in the model with repeated values for a subject.||||||0.1311|||||||Mixed Models Analysis||||
1595469|NCT02954575|2933696|Other||Pearson-Copper|0.0|||||2-Sided|95.0|0.0|16.11|||||||
1595470|NCT02954575|2933698|Other|||||||0.4244|||||||ANOVA||||
1595471|NCT02954575|2933699|Other|||||||0.0346|||||||ANOVA||||
1595472|NCT02954575|2933705|Other||Generalized estimation equation|84.21||||0.0096|2-Sided|95.0|72.13|92.52|||Confirmatory data analysis|||"Confirmatory statistical testing tested the null hypotheses that the percentage of success is ≤70% (alternative hypothesis: percentage >70%); the test procedure based on the generalized estimation equation took into account several BEs in one patient as correlated repeated measurements (alpha = 2.5%). Thus, π denotes the proportion of success and the following pair of hypotheses was tested:~H0: π ≤ 0.7 vs. H1: π > 0.7"|
1595473|NCT02954575|2933706|Other||Poisson test estimate|1.53|||<|0.0001|2-Sided|95.0|1.13|2.08||versus mean SABR >19.1|Poisson test estimate|||A confirmative one-sided, one-sample Poisson test was used to test whether the mean SABR in patients treated prophylactically with Wilate was below the threshold of 19.1 BEs per patient year (alpha = 2.5%). This threshold corresponds to 50% of the SABR in the GENA-01 study (NCT00989196), which observed 38.2 spontaneous BEs per patient per year. A corresponding two-sided 95% CI for the SABR was also analyzed.|
1595474|NCT02954575|2933707|Other||Poisson test estimate|2.13|||<|0.0001|2-Sided|95.0|1.64|2.76||versus mean TABR >29|Poisson test estimate|||A confirmative one-sided, one-sample Poisson test was used to test whether the mean annualized bleeding rate (ABR) in patients treated prophylactically with Wilate was below the threshold of 29 BEs per patient year (alpha = 2.5%). This threshold corresponds to 50% of the TABR reported in the GENA-01 study (NCT00989196), which observed 58.1 BEs per patient per year. A corresponding two-sided 95% CI for the TABR was also analyzed.|
1595475|NCT02954354|2933709|Superiority|||||||0.2217||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications|
1595476|NCT02954354|2933710|Superiority|||||||0.6728||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications|
1595477|NCT02954354|2933711|Superiority||Difference|-0.6||||0.7176||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595478|NCT02954354|2933712|Superiority|The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Difference|-39.5||||0.0563|||||||Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595479|NCT02954354|2933713|Superiority||Difference|2.2||||0.4241||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Fatigue|
1595480|NCT02954354|2933713|Superiority||Difference|-0.7||||0.676||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Muscle or joint pain|
1595481|NCT02954354|2933713|Superiority||Difference|-0.1||||0.9973||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Feverishness or chills|
1595482|NCT02954354|2933713|Superiority||Difference|1.7||||0.3706||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Nasal congestion|
1595483|NCT02954354|2933713|Superiority||Difference|1.3||||0.9989||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Headache|
1595484|NCT02954354|2933713|Superiority||Difference|1.8||||0.8184||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Sore throat|
1595485|NCT02954354|2933713|Superiority||Difference|6.8||||0.6623||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Cough|
1595486|NCT02954354|2933714|Superiority||Difference|-15.3||||0.0007||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Fatigue|
1595487|NCT02954354|2933714|Superiority||Difference|-8.1||||0.0094||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Muscle or joint pain|
1595488|NCT02954354|2933714|Superiority||Difference|-4.9||||0.0003||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||Feverishness or chills|
1595489|NCT02954354|2933714|Superiority||Difference|-20.7||||0.0027||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Nasal Congestion|
1595490|NCT02954354|2933714|Superiority||Difference|-11.8||||0.0297||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Headache|
1595491|NCT02954354|2933714|Superiority||Difference|-9.0||||0.0298||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Sore throat|
1595492|NCT02954354|2933714|Superiority||Difference|-23.1||||0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Cough|
1595493|NCT02954354|2933715|Superiority||LS Mean Difference|0.05|Standard Error of the Mean|0.04||0.157|2-Sided|95.0|-0.02|0.13||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||120 hours|
1595494|NCT02954354|2933715|Superiority||LS Mean Difference|0.03|Standard Error of the Mean|0.04||0.4532|2-Sided|95.0|-0.05|0.11||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||96 hours|
1595495|NCT02954354|2933715|Superiority||LS Mean Difference|-0.01|Standard Error of the Mean|0.04||0.852|2-Sided|95.0|-0.09|0.07||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||72 hours|
1595496|NCT02954354|2933715|Superiority||LS Mean Difference|-0.02|Standard Error of the Mean|0.04||0.6574|2-Sided|95.0|-0.1|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||48 hours|
1595497|NCT02954354|2933715|Superiority||LS Mean Difference|0.0|Standard Error of the Mean|0.05||0.9258|2-Sided|95.0|-0.09|0.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||36 hours|
1595498|NCT02954354|2933715|Superiority||LS Mean Difference|0.05|Standard Error of the Mean|0.05||0.3343|2-Sided|95.0|-0.05|0.16||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||24 hours|
1595499|NCT02954354|2933715|Superiority||LS Mean Difference|0.11|Standard Error of the Mean|0.07||0.0937|2-Sided|95.0|-0.02|0.24||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||12 hours|
1595500|NCT02954354|2933716|Superiority||LS Mean Difference|0.02|Standard Error of the Mean|0.05||0.5963|2-Sided|95.0|-0.07|0.11||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.|
1595501|NCT02954354|2933716|Superiority||LS Mean Dfference|-0.04|Standard Error of the Mean|0.05||0.4484|2-Sided|95.0|-0.13|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||96 hours|
1595502|NCT02954354|2933716|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.31|-0.13||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||72 hours|
1595503|NCT02954354|2933716|Superiority||LS Mean Difference|-0.37|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.48|-0.27||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||48 hours|
1595504|NCT02954354|2933716|Superiority||LS Mean Difference|-0.41|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.52|-0.29||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||36 hours|
1595505|NCT02954354|2933716|Superiority||LS Mean Difference|-0.34|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.46|-0.22||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||24 hours|
1595506|NCT02954354|2933716|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.08|<|0.2557|2-Sided|95.0|-0.24|0.06||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score and region (Japan/Asia, Rest of the world) and body temperature at baseline as covariates.||12 hours|
1595507|NCT02954354|2933717|Superiority|||||||0.5573||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.m|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours|
1595508|NCT02954354|2933717|Superiority|||||||0.8644||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours|
1595509|NCT02954354|2933717|Superiority|||||||0.2975||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours|
1595510|NCT02954354|2933717|Superiority|||||||0.5908||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||144 hours|
1595511|NCT02954354|2933717|Superiority|||||||0.4157||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours|
1595512|NCT02954354|2933717|Superiority|||||||0.8033||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||96 hours|
1595513|NCT02954354|2933717|Superiority|||||||0.0215||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours|
1595514|NCT02954354|2933717|Superiority|||||||0.7771||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world)||48 hours|
1595515|NCT02954354|2933717|Superiority|||||||0.2079||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours|
1595516|NCT02954354|2933717|Superiority|||||||0.5414||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours|
1595517|NCT02954354|2933717|Superiority|||||||0.2953||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours|
1595518|NCT02954354|2933718|Superiority|||||||0.9312||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours|
1595519|NCT02954354|2933718|Superiority|||||||0.8644||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours|
1595520|NCT02954354|2933718|Superiority|||||||0.8291||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours|
1595645|NCT02952898|2933794|Superiority||||||<|0.0001|||||||Chi-squared, Corrected|||Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of GDC 695 gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.|
1595521|NCT02954354|2933718|Superiority|||||||0.8783||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours|
1595522|NCT02954354|2933718|Superiority|||||||0.8512||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours|
1595523|NCT02954354|2933718|Superiority|||||||0.7044||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours|
1595524|NCT02954354|2933718|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours|
1595525|NCT02954354|2933718|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours|
1595526|NCT02954354|2933718|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours|
1595527|NCT02954354|2933718|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours|
1595528|NCT02954354|2933718|Superiority||||||<|0.7866||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours|
1595529|NCT02954354|2933719|Superiority|||||||0.9225||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595530|NCT02954354|2933720|Superiority||Difference|-17.5|||<|0.0001|2-Sided|95.0|-21.1|-11.9||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595531|NCT02954354|2933721|Superiority||LS Mean Difference|0.1|Standard Error of the Mean|0.2||0.6001|2-Sided|95.0|-0.3|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||216 hours|
1595532|NCT02954354|2933721|Superiority||LS Mean Difference|0.4|Standard Error of the Mean|0.2||0.0274|2-Sided|95.0|0.0|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||192 hours|
1595533|NCT02954354|2933721|Superiority||LS Mean Difference|0.2|Standard Error of the Mean|0.2||0.2765|2-Sided|95.0|-0.2|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||168 hours|
1595534|NCT02954354|2933721|Superiority||LS Mean Difference|0.1|Standard Error of the Mean|0.2||0.7046|2-Sided|95.0|-0.3|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||144 hours|
1595535|NCT02954354|2933721|Superiority||LS Mean Difference|0.3|Standard Error of the Mean|0.2||0.135|2-Sided|95.0|-0.1|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||120 hours|
1595536|NCT02954354|2933721|Superiority||LS Mean Difference|0.1|Standard Error of the Mean|0.2||0.7187|2-Sided|95.0|-0.3|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||96 hours|
1595537|NCT02954354|2933721|Superiority||LS Mean Difference|0.1|Standard Error of the Mean|0.2||0.6703|2-Sided|95.0|-0.4|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||72 hours|
1595538|NCT02954354|2933721|Superiority||LS Mean Difference|0.2|Standard Error of the Mean|0.2||0.4285|2-Sided|95.0|-0.3|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||48 hours|
1595539|NCT02954354|2933721|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.3||0.3465|2-Sided|95.0|-0.8|0.3||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||36 hours|
1595646|NCT02952872|2933795|Superiority||||||<|0.05|||||||ANOVA||||
1595647|NCT02952872|2933796|Superiority||||||<|0.05|||||||ANOVA||||
1595540|NCT02954354|2933721|Superiority||LS Mean Difference|0.3|Standard Error of the Mean|0.3||0.3073|2-Sided|95.0|-0.3|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||24 hours|
1595541|NCT02954354|2933721|Superiority||LS Mean Difference|0.2|Standard Error of the Mean|0.3||0.4091|2-Sided|95.0|-0.3|0.8||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||12 hours|
1595542|NCT02954354|2933722|Superiority||LS Mean Difference|0.0|Standard Error of the Mean|0.3||0.9525|2-Sided|95.0|-0.6|0.6||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||216 hours|
1595543|NCT02954354|2933722|Superiority||LS Mean Difference|0.1|Standard Error of the Mean|0.2||0.8057|2-Sided|95.0|-0.4|0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||192 hours|
1595544|NCT02954354|2933722|Superiority||LS Mean Difference|-0.1|Standard Error of the Mean|0.2||0.5805|2-Sided|95.0|-0.6|0.3||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||168 hours|
1595545|NCT02954354|2933722|Superiority||LS Mean Difference|-0.4|Standard Error of the Mean|0.2||0.1079|2-Sided|95.0|-0.8|0.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||144 hours|
1595546|NCT02954354|2933722|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.2||0.1979|2-Sided|95.0|-0.8|0.2||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||120 hours|
1595547|NCT02954354|2933722|Superiority||LS Mean Difference|-1.0|Standard Error of the Mean|0.3||0.0001|2-Sided|95.0|-1.5|-0.5||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||96 hours|
1595548|NCT02954354|2933722|Superiority||LS Mean Difference|-1.4|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|-2.0|-0.9||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||72 hours|
1595549|NCT02954354|2933722|Superiority||LS Mean Difference|-1.8|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|-2.4|-1.2||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||48 hours|
1595550|NCT02954354|2933722|Superiority||LS Mean Difference|-1.8|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|-2.4|-1.1||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||36 hours|
1595551|NCT02954354|2933722|Superiority||LS Mean Difference|-1.1|Standard Error of the Mean|0.3|<|0.0009|2-Sided|95.0|-1.7|-0.4||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||24 hours|
1595552|NCT02954354|2933722|Superiority||LS Mean Difference|0.1|Standard Error of the Mean|0.3|<|0.7173|2-Sided|95.0|-0.5|0.7||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with baseline composite symptom score baseline (≤ 11 or ≥ 12)and region (Japan/Asia, Rest of the world) as covariates.||12 hours|
1595553|NCT02954354|2933723|Superiority||Difference|1.3||||0.4856||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595554|NCT02954354|2933724|Superiority|The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Difference|-23.1|||<|0.0001|||||||Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595555|NCT02954354|2933725|Superiority||Difference|-0.7||||0.4194||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595556|NCT02954354|2933726|Superiority||Difference|-19.8|||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595557|NCT02954354|2933727|Superiority|||||||0.0409||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours|
1595648|NCT02952872|2933797|Superiority||||||<|0.05|||||||ANOVA||||
1595649|NCT02952872|2933798|Superiority||||||<|0.05|||||||ANOVA|Mixed Design ANOVA|||
1595558|NCT02954354|2933727|Superiority|||||||0.0413||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours|
1595559|NCT02954354|2933727|Superiority|||||||0.2144||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours|
1595560|NCT02954354|2933727|Superiority|||||||0.5317||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours|
1595561|NCT02954354|2933727|Superiority|||||||0.9257||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours|
1595562|NCT02954354|2933727|Superiority|||||||0.9881||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours|
1595563|NCT02954354|2933727|Superiority|||||||0.6029||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours|
1595564|NCT02954354|2933727|Superiority|||||||0.4442||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours|
1595565|NCT02954354|2933727|Superiority|||||||0.3297||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours|
1595566|NCT02954354|2933727|Superiority|||||||0.7565||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours|
1595567|NCT02954354|2933727|Superiority|||||||0.0458||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours|
1595568|NCT02954354|2933728|Superiority|||||||0.8657||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||216 hours|
1595569|NCT02954354|2933728|Superiority|||||||0.9453||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||192 hours|
1595570|NCT02954354|2933728|Superiority|||||||0.0757||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||168 hours|
1595571|NCT02954354|2933728|Superiority|||||||0.117||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||144 hours|
1595572|NCT02954354|2933728|Superiority|||||||0.1298||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||120 hours|
1595573|NCT02954354|2933728|Superiority|||||||0.0115||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||96 hours|
1595574|NCT02954354|2933728|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||72 hours|
1595575|NCT02954354|2933728|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||48 hours|
1595576|NCT02954354|2933728|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||36 hours|
1595577|NCT02954354|2933728|Superiority||||||<|0.001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||24 hours|
1595578|NCT02954354|2933728|Superiority||||||<|0.5973||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||12 hours|
1595741|NCT02951052|2933958|Other||Adjusted difference|5.3||||0.008|2-Sided|95.0|1.4|9.1|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.||
1620535|NCT02314923|2977569|Other||||||<|0.003|||||||ANOVA||||
1595579|NCT02954354|2933729|Superiority||Difference|-24.0||||0.0102|2-Sided|95.0|-48.0|24.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595580|NCT02954354|2933730|Superiority||Difference|-24.0||||0.002|2-Sided|95.0|-120.0|0.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595581|NCT02954354|2933731|Superiority||Difference|-48.0|||<|0.0001|2-Sided|95.0|-72.0|-24.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595582|NCT02954354|2933732|Superiority||Difference|-72.0|||<|0.0001|2-Sided|95.0|-72.0|-48.0||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595583|NCT02954354|2933733|Superiority|||||||0.2424||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595584|NCT02954354|2933734|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595585|NCT02954354|2933735|Superiority|||||||0.0313||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595586|NCT02954354|2933736|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).|||
1595587|NCT02954354|2933737|Superiority|||||||0.8491||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9|
1595588|NCT02954354|2933737|Superiority|||||||0.9619||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6|
1595589|NCT02954354|2933737|Superiority|||||||0.0338||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5|
1595590|NCT02954354|2933737|Superiority|||||||0.4148||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4|
1595591|NCT02954354|2933737|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3|
1595592|NCT02954354|2933737|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2|
1595593|NCT02954354|2933738|Superiority|||||||0.0002||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9|
1595594|NCT02954354|2933738|Superiority|||||||0.001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6|
1595595|NCT02954354|2933738|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5|
1595596|NCT02954354|2933738|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4|
1595597|NCT02954354|2933738|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3|
1595598|NCT02954354|2933738|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2|
1595599|NCT02954354|2933739|Superiority|||||||0.3332||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9|
1595742|NCT02951052|2933959|Other||Adjusted difference|6.4|||<|0.001|2-Sided|95.0|4.0|8.8|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.||
1595600|NCT02954354|2933739|Superiority|||||||0.2256||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6|
1595601|NCT02954354|2933739|Superiority|||||||0.9451||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5|
1595602|NCT02954354|2933739|Superiority|||||||0.801||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4|
1595603|NCT02954354|2933739|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3|
1595604|NCT02954354|2933739|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2|
1595605|NCT02954354|2933740|Superiority|||||||0.1677||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9|
1595606|NCT02954354|2933740|Superiority|||||||0.9307||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6|
1595607|NCT02954354|2933740|Superiority|||||||0.0132||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5|
1595608|NCT02954354|2933740|Superiority|||||||0.0008||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4|
1595609|NCT02954354|2933740|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3|
1595610|NCT02954354|2933740|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2|
1595611|NCT02954354|2933741|Superiority|||||||0.2548||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9|
1595612|NCT02954354|2933741|Superiority|||||||0.0898||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6|
1595613|NCT02954354|2933741|Superiority|||||||0.0241||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5|
1595614|NCT02954354|2933741|Superiority|||||||0.5479||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4|
1595615|NCT02954354|2933741|Superiority|||||||0.1379||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3|
1595616|NCT02954354|2933741|Superiority|||||||0.2266||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2|
1595617|NCT02954354|2933742|Superiority|||||||0.0049||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9|
1595618|NCT02954354|2933742|Superiority|||||||0.7393||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6|
1595619|NCT02954354|2933742|Superiority|||||||0.0095||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5|
1595620|NCT02954354|2933742|Superiority|||||||0.419||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4|
1595621|NCT02954354|2933742|Superiority|||||||0.2505||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3|
1598434|NCT02900378|2936703|Other|||||||0.6499|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6|
1595622|NCT02954354|2933742|Superiority|||||||0.6145||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2|
1595623|NCT02954354|2933743|Superiority|||||||0.8637||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|||Day 9|
1595624|NCT02954354|2933743|Superiority|||||||0.6187||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6|
1595625|NCT02954354|2933743|Superiority|||||||0.0063||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5|
1595626|NCT02954354|2933743|Superiority|||||||0.0852||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4|
1595627|NCT02954354|2933743|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3|
1595628|NCT02954354|2933743|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2|
1595629|NCT02954354|2933744|Superiority|||||||0.3353||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 9|
1595630|NCT02954354|2933744|Superiority|||||||0.4767||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 6|
1595631|NCT02954354|2933744|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 5|
1595632|NCT02954354|2933744|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 4|
1595633|NCT02954354|2933744|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 3|
1595634|NCT02954354|2933744|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Day 2|
1595635|NCT02954354|2933745|Superiority|||||||0.3761||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Analysis using the stratified log rank test was performed as a sensitivity analysis.|
1595636|NCT02954354|2933745|Superiority||Difference|-0.3||||0.756|2-Sided|95.0|-6.6|6.6||Adjusted p-value, two-sided significance level of 0.05|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||A secondary analysis of time to alleviation of symptoms, consisting of a comparison between the 20 to 64 years of age stratum of the baloxavir group and the oseltamivir group, was conducted if statistical significance was observed in the primary analysis in order to maintain the overall Type I error.|
1595637|NCT02954354|2933746|Superiority||||||<|0.0001||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||Analysis using the stratified log rank test was performed as a sensitivity analysis.|
1595638|NCT02954354|2933746|Superiority||Difference|-26.5|||<|0.0001|2-Sided|95.0|-35.8|-17.8||Adjusted p-value, two-sided significance level of 0.05|Generalized Wilcoxon test|Generalized Wilcoxon test stratified by composite symptom scores at baseline (≤ 11 or ≥ 12) and region (Japan/Asia or Rest of the world).||The primary analysis of time to alleviation of symptoms was a comparison of baloxavir with placebo in all participants in the intention-to-treat infection population. Statistical tests were performed at the 0.05 significance level.|
1595639|NCT02953938|2933751|Superiority||Mean Difference (Final Values)|11.32||||0.7602|2-Sided|95.0|-62.65|85.28|||ANOVA||||
1595640|NCT02953938|2933753|Superiority||Mean Difference (Final Values)|0.06|Standard Deviation|0.051||0.2707|2-Sided|95.0|-0.045|0.158|||ANOVA||||
1595641|NCT02953938|2933754|Superiority||Mean Difference (Final Values)|-6.58|Standard Deviation|3.042||0.0349|2-Sided|95.0|-12.67|-0.48|||ANOVA||||
1595642|NCT02953938|2933755|Superiority||Mean Difference (Net)|-0.21|Standard Deviation|0.64||0.368|2-Sided|95.0|-1.49|1.07|||Cochran-Mantel-Haenszel||||
1595643|NCT02953678|2933773|Other||Exact method for binomial distributions|54.9|||||2-Sided|95.0|42.7|66.8|||||||
1595644|NCT02952898|2933794|Superiority||||||<|0.0001|||||||Chi-squared, Corrected|||Two-sided, continuity-corrected Chi-square tests was used to evaluate the superiority of Diclofenac sodium gel's complete clearance proportion over that of the Vehicle treatment in the mITT population using LOCF.|
1597104|NCT02918071|2935676|Other||Percentage|93.1|||||2-Sided|95.0|86.86|96.98|||||Percentage of patients who successfully administered benralizumab with an AI at home (Week 12 and 16)||
1595650|NCT02952820|2933812|Superiority||LSM Difference|0.261|Standard Error of the Mean|0.12||0.0298|2-Sided|95.0|0.026|0.497|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.|
1595651|NCT02952820|2933812|Superiority||LSM Difference|0.144|Standard Error of the Mean|0.119||0.2248|2-Sided|95.0|-0.089|0.378|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.|
1595652|NCT02952820|2933812|Superiority||LSM Difference|0.255|Standard Error of the Mean|0.11||0.0208|2-Sided|95.0|0.039|0.471|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.|
1595653|NCT02952820|2933812|Superiority||LSM Difference|0.074|Standard Error of the Mean|0.109||0.4992|2-Sided|95.0|-0.141|0.289|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.|
1595654|NCT02952820|2933812|Superiority||LSM Difference|0.073|Standard Error of the Mean|0.094||0.4347|2-Sided|95.0|-0.111|0.258|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.|
1595655|NCT02952820|2933812|Superiority||LSM Difference|0.077|Standard Error of the Mean|0.094||0.412|2-Sided|95.0|-0.107|0.261|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.|
1595656|NCT02952820|2933812|Superiority||LSM Difference|0.171|Standard Error of the Mean|0.076||0.0237|2-Sided|95.0|0.023|0.32|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.|
1595657|NCT02952820|2933812|Superiority||LSM Difference|0.205|Standard Error of the Mean|0.076||0.0067|2-Sided|95.0|0.057|0.353|||Mixed Models Analysis|||First 7 nights (Statistical analysis): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline Mean Rating on Morning Sleepiness as a covariate. Missing values are not imputed and assumed to be MAR.|
1595658|NCT02952820|2933813|Superiority||LSM Difference|-2.56|Standard Error of the Mean|1.026||0.0128|2-Sided|95.0|-4.57|-0.54|||Mixed Models Analysis|||Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.|
1595659|NCT02952820|2933813|Superiority||LSM Difference|-2.5|Standard Error of the Mean|0.112||0.0134|2-Sided|95.0|-4.48|-0.52|||Mixed Models Analysis|||Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.|
1595660|NCT02952820|2933813|Superiority||LSM Difference|-3.04|Standard Error of the Mean|0.95||0.0014|2-Sided|95.0|-4.91|-1.18|||Mixed Models Analysis|||Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.|
1595661|NCT02952820|2933813|Superiority||LSM Difference|-2.18|Standard Error of the Mean|0.939||0.0206|2-Sided|95.0|-4.02|-0.34|||Mixed Models Analysis|||Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.|
1595662|NCT02952820|2933813|Superiority||LSM Difference|-2.04|Standard Error of the Mean|0.913||0.0257|2-Sided|95.0|-3.83|-0.25|||Mixed Models Analysis|||Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.|
1595663|NCT02952820|2933813|Superiority||LSM Difference|-1.66|Standard Error of the Mean|0.905||0.067|2-Sided|95.0|-3.44|0.12|||Mixed Models Analysis|||Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline FSS score as a covariate. Missing values are not imputed and assumed to be MAR.|
1595664|NCT02952820|2933814|Superiority||LSM Difference|-1.32|Standard Error of the Mean|0.307|<|0.0001|2-Sided|95.0|-1.92|-0.71|||Mixed Models Analysis|||Month 6 (Statistical analysis 6): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.|
1595665|NCT02952820|2933814|Superiority||LSM Difference|-1.3|Standard Error of the Mean|0.302|<|0.0001|2-Sided|95.0|-1.9|-0.71|||Mixed Models Analysis|||Month 6 (Statistical analysis 5): Based on MMRM model with factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.|
1595666|NCT02952820|2933814|Superiority||LSM Difference|-1.36|Standard Error of the Mean|0.305|<|0.0001|2-Sided|95.0|-1.96|-0.76|||Mixed Models Analysis|||Month 3 (Statistical analysis 4): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.|
1620536|NCT02314923|2977569|Other||||||<|0.303|||||||ANOVA||||
1595667|NCT02952820|2933814|Superiority||LSM Difference|-1.16|Standard Error of the Mean|0.302|<|0.0001|2-Sided|95.0|-1.75|-0.57|||Mixed Models Analysis|||Month 3 (Statistical analysis 3): Based on MMRM model with factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.|
1595668|NCT02952820|2933814|Superiority||LSM Difference|-0.94|Standard Error of the Mean|0.289|<|0.0011|2-Sided|95.0|-1.51|-0.38|||Mixed Models Analysis|||Month 1 (Statistical analysis 2): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.|
1595669|NCT02952820|2933814|Superiority||LSM Difference|-0.71|Standard Error of the Mean|0.287|<|0.0137|2-Sided|95.0|-1.27|-0.15|||Mixed Models Analysis|||Month 1 (Statistical analysis 1): Based on MMRM model with factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and study baseline ISI score as a covariate. Missing values are not imputed and assumed to be MAR.|
1595670|NCT02952820|2933816|Superiority||Difference of percentage|9.82||||0.011|2-Sided|95.0|2.29|17.35|||Cochran-Mantel-Haenszel|||Sleep Maintenance Responders: Statistical analysis 4|
1595671|NCT02952820|2933816|Superiority||Difference of percentage|14.65||||0.0002|2-Sided|95.0|6.97|22.33|||Cochran-Mantel-Haenszel|||Sleep Maintenance Responders: Statistical analysis 3|
1595672|NCT02952820|2933816|Superiority||Difference of percentage|12.53||||0.0009|2-Sided|95.0|5.2|19.86|||Cochran-Mantel-Haenszel|||Sleep Onset Responders: Statistical analysis 2|
1595673|NCT02952820|2933816|Superiority||Difference of percentage|13.67||||0.0004|2-Sided|95.0|6.24|21.1|||Cochran-Mantel-Haenszel|||Sleep onset responders: Statistical analysis 1|
1595674|NCT02952820|2933817|Superiority||LSM Difference|22.686|Standard Error of the Mean|6.392||0.0004|2-Sided|95.0|10.137|35.234|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.|
1595675|NCT02952820|2933817|Superiority||LSM Difference|18.555|Standard Error of the Mean|6.324||0.0034|2-Sided|95.0|6.14|30.969|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be missing at random (MAR).|
1595676|NCT02952820|2933817|Superiority||LSM Difference|21.686|Standard Error of the Mean|5.946||0.0003|2-Sided|95.0|10.014|33.359|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.|
1595677|NCT02952820|2933817|Superiority||LSM Difference|17.374|Standard Error of the Mean|5.906||0.0034|2-Sided|95.0|5.781|28.968|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.|
1595678|NCT02952820|2933817|Superiority||LSM Difference|22.131|Standard Error of the Mean|5.286|<|0.0001|2-Sided|95.0|11.757|32.505|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.|
1595679|NCT02952820|2933817|Superiority||LSM Difference|11.76|Standard Error of the Mean|5.269|<|0.0259|2-Sided|95.0|1.418|22.102|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.|
1595680|NCT02952820|2933817|Superiority||LSM Difference|31.796|Standard Error of the Mean|4.35|<|0.0001|2-Sided|95.0|23.258|40.334|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.|
1595681|NCT02952820|2933817|Superiority||LSM Difference|22.034|Standard Error of the Mean|4.354|<|0.0001|2-Sided|95.0|13.488|30.579|||Mixed Models Analysis|||First 7 Nights After the First Dose (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sTST as a covariate. Missing values are not imputed and assumed to be MAR.|
1595682|NCT02952820|2933818|Superiority||LSM Difference|-12.671|Standard Error of the Mean|4.951||0.0105|2-Sided|95.0|-22.378|-2.964|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595683|NCT02952820|2933818|Superiority||LSM Difference|-17.474|Standard Error of the Mean|5.014||0.0005|2-Sided|95.0|-27.306|-7.643|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595684|NCT02952820|2933818|Superiority||LSM Difference|-10.079|Standard Error of the Mean|4.578||0.0277|2-Sided|95.0|-19.053|-1.104|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595700|NCT02952820|2933820|Superiority||LSGM ratio|0.77|||<|0.0001|2-Sided|95.0|0.698|0.848|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595685|NCT02952820|2933818|Superiority||LSM Difference|-13.424|Standard Error of the Mean|4.486||0.0028|2-Sided|95.0|-22.218|-4.631|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595686|NCT02952820|2933818|Superiority||LSM Difference|-7.005|Standard Error of the Mean|4.129||0.0898|2-Sided|95.0|-15.098|1.088|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595687|NCT02952820|2933818|Superiority||LSM Difference|-5.514|Standard Error of the Mean|4.109||0.1796|2-Sided|95.0|-13.568|2.54|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595688|NCT02952820|2933818|Superiority||LSM Difference|-16.72|Standard Error of the Mean|3.619|<|0.0001|2-Sided|95.0|-23.813|-9.626|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595689|NCT02952820|2933818|Superiority||Least square mean (LSM) Difference|-14.328|Standard Error of the Mean|3.614|<|0.0001|2-Sided|95.0|-21.411|-7.245|||Mixed Models Analysis|||First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sWASO as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595690|NCT02952820|2933819|Superiority||LSM Difference|4.667|Standard Error of the Mean|1.17|<|0.0001|2-Sided|95.0|2.373|6.96|||Mixed Models Analysis|||Month 6 (Statistical analysis 8): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595691|NCT02952820|2933819|Superiority||LSM Difference|4.549|Standard Error of the Mean|1.179|<|0.0001|2-Sided|95.0|2.236|6.861|||Mixed Models Analysis|||Month 6 (Statistical analysis 7): Based on MMRM model with factors of age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595692|NCT02952820|2933819|Superiority||LSM Difference|4.361|Standard Error of the Mean|1.092|<|0.0001|2-Sided|95.0|2.22|6.501|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595693|NCT02952820|2933819|Superiority||LSM Difference|4.222|Standard Error of the Mean|1.099|<|0.0001|2-Sided|95.0|2.068|6.377|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with factors of age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595694|NCT02952820|2933819|Superiority||LSM Difference|3.615|Standard Error of the Mean|1.01|<|0.0003|2-Sided|95.0|1.635|5.595|||Mixed Models Analysis|||Month 1 (Statistical analysis 4): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595695|NCT02952820|2933819|Superiority||LSM Difference|2.227|Standard Error of the Mean|0.979|<|0.023|2-Sided|95.0|0.307|4.146|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with factors of age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595696|NCT02952820|2933819|Superiority||LSM Difference|5.793|Standard Error of the Mean|0.846|<|0.0001|2-Sided|95.0|4.133|7.452|||Mixed Models Analysis|||First 7 nights (Statistical analysis 2): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595697|NCT02952820|2933819|Superiority||LSM Difference|4.299|Standard Error of the Mean|0.848|<|0.0001|2-Sided|95.0|2.638|5.961|||Mixed Models Analysis|||First 7 nights (Statistical analysis 1): Based on MMRM model with factors of age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effect, and the study baseline sSE as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595698|NCT02952820|2933820|Superiority||LSGM ratio|0.77|||<|0.0001|2-Sided|95.0|0.681|0.869|||Mixed Models Analysis|||Month 3 (Statistical analysis 6): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595699|NCT02952820|2933820|Superiority||LSGM ratio|0.778|||<|0.0001|2-Sided|95.0|0.69|0.878|||Mixed Models Analysis|||Month 3 (Statistical analysis 5): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 3), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595740|NCT02951052|2933958|Other||Adjusted difference|2.0||||0.347|2-Sided|95.0|-2.2|6.2|||ANCOVA||||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.
1620537|NCT02314923|2977569|Other||||||<|0.027|||||||ANOVA||||
1595701|NCT02952820|2933820|Superiority||LSGM ratio|0.81|||<|0.0001|2-Sided|95.0|0.735|0.893|||Mixed Models Analysis|||Month 1 (Statistical analysis 3): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 1), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595702|NCT02952820|2933820|Superiority||LSGM ratio|0.752|||<|0.0001|2-Sided|95.0|0.698|0.811|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 2): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595703|NCT02952820|2933820|Superiority||LSGM ratio|0.781|||<|0.0001|2-Sided|95.0|0.725|0.842|||Mixed Models Analysis|||First 7 nights after the first dose (Statistical analysis 1): Based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (First 7 nights), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595704|NCT02952820|2933821|Superiority||LSGM ratio|0.701|||<|0.0001|2-Sided|95.0|0.607|0.81|||Mixed Models Analysis|||Analysis was based on MMRM model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (MNAR/CCMV).|
1595705|NCT02952820|2933821|Superiority||least squares geometric mean (LSGM)ratio|0.732|||<|0.0001|2-Sided|95.0|0.636|0.843|||Mixed Models Analysis|||Analysis was based on mixed effect model repeated measurement analysis (MMRM) model with log transformation of sSOL and factors for age group, region, treatment, visit (Month 6), and treatment-by-visit interaction as fixed effects, and the study baseline sSOL as a covariate. Missing values are imputed using multiple imputation and assumed to be missing not at random (missing not at random/complete case missing value [MNAR/CCMV]).|
1595706|NCT02951988|2933833|Superiority|||||||0.4123|||||||Log Rank||||
1595707|NCT02951988|2933833|Superiority|||||||0.6153|||||||Log Rank||||
1595708|NCT02951988|2933834|Superiority|||||||0.4628|||||||Log Rank||||
1595709|NCT02951988|2933834|Superiority|||||||0.5305|||||||Log Rank||||
1595710|NCT02951533|2933912|Superiority||||||<|0.0001|||||||Chi-squared||||
1595711|NCT02951351|2933913|Superiority|||||||0.67|||||||Wilcoxon (Mann-Whitney)||||
1595712|NCT02951351|2933914|Superiority|||||||0.18|||||||Wilcoxon (Mann-Whitney)||||
1595713|NCT02951351|2933915|Superiority|||||||0.31|||||||Wilcoxon (Mann-Whitney)||||
1595714|NCT02951351|2933916|Superiority|||||||0.76|||||||Wilcoxon (Mann-Whitney)||||
1595715|NCT02951351|2933917|Superiority|||||||0.48|||||||Wilcoxon (Mann-Whitney)||||
1595716|NCT02951351|2933918|Superiority|||||||0.86|||||||Wilcoxon (Mann-Whitney)||||
1595717|NCT02951351|2933919|Superiority|||||||0.25|||||||Wilcoxon (Mann-Whitney)||||
1595718|NCT02951351|2933920|Non-Inferiority|By non-inferiority analysis, proparacaine was inferior to povidone iodine with a 5% margin for non-inferiority. To detect non-inferiority with one positive culture in the proparacaine group, 45 patients would be required in the proparacaine group with a 5% margin.||||||0.28|||||||Wilcoxon (Mann-Whitney)||||
1595719|NCT02951273|2933939|Superiority||||||<|0.0001|||||||repeated measure mixed model||||
1595720|NCT02951273|2933940|Superiority||||||<|0.0001|||||||repeated measure mixed model||||
1595721|NCT02951273|2933941|Superiority||||||<|0.0001|||||||Mixed Models Analysis||||
1595722|NCT02951273|2933942|Superiority||||||<|0.0001|||||||repeated measure mixed model||||
1595723|NCT02951273|2933943|Superiority|||||||0.0068|||||||Linear mixed models||||
1595724|NCT02951273|2933944|Superiority|||||||0.8947|||||||repeated measure mixed model||||
1595725|NCT02951273|2933945|Superiority|||||||0.5404|||||||repeated measure mixed model||||
1595726|NCT02951273|2933946|Superiority|||||||0.0005||||||The reported p-value was calculated|repeated measure mixed model||||
1595727|NCT02951273|2933947|Superiority|||||||0.3213|||||||repeated measure mixed model||||
1595728|NCT02951273|2933948|Superiority|||||||0.6025|||||||Regression, Linear||||
1595729|NCT02951273|2933949|Superiority||||||<|0.0001|||||||repeated measure mixed model||||
1595730|NCT02951273|2933950|Superiority|||||||0.0276|||||||repeated measure mixed model||||
1595731|NCT02951052|2933954|Other||Adjusted difference|10.7|||<|0.001|2-Sided|95.0|7.1|14.4|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.||
1595732|NCT02951052|2933954|Other||Adjusted difference|6.9|||<|0.001|2-Sided|95.0|3.3|10.4|||ANCOVA||Treatment comparison Week 24 for the groups CAB LA+ RPV LA and current ART is presented.||
1595733|NCT02951052|2933954|Other||Adjusted difference|7.9|||<|0.001|2-Sided|95.0|4.1|11.7|||ANCOVA||Treatment comparison at Week 8 for the groups CAB LA+ RPV LA and current ART is presented.||
1595734|NCT02951052|2933957|Other||Adjusted difference|0.696||||0.092|2-Sided|95.0|-0.113|1.505|||ANCOVA||Treatment comparison of SF-12 PCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.||
1595735|NCT02951052|2933957|Other||Adjusted difference|0.697||||0.086|2-Sided|95.0|-0.1|1.494|||ANCOVA||Treatment comparison of SF-12 PCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.||
1595736|NCT02951052|2933957|Other||Adjusted difference|0.635||||0.327|2-Sided|95.0|-0.637|1.907|||ANCOVA||Treatment comparison of SF-12 MCS at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.||
1595737|NCT02951052|2933957|Other||Adjusted difference|0.676||||0.282|2-Sided|95.0|-0.557|1.909|||ANCOVA||Treatment comparison of SF-12 MCS at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.||
1595738|NCT02951052|2933957|Other||Adjusted difference|-0.1||||0.785|2-Sided|95.0|-0.6|0.4|||ANCOVA||Treatment comparison of SF-12 total scores at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.||
1595739|NCT02951052|2933957|Other||Adjusted difference|0.2||||0.344|2-Sided|95.0|-0.2|0.7|||ANCOVA||Treatment comparison of SF-12 total scores at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.||
1595743|NCT02951052|2933959|Other||Adjusted difference|4.9|||<|0.001|2-Sided|95.0|2.8|7.1|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.||
1595744|NCT02951052|2933960|Other||Adjusted difference|1.0||||0.385|2-Sided|95.0|-1.3|3.4|||ANCOVA||Treatment comparison at Week 48 for the groups CAB LA+ RPV LA and current ART is presented.||
1595745|NCT02951052|2933960|Other||Adjusted difference|-0.1||||0.944|2-Sided|95.0|-2.4|2.2|||ANCOVA||Treatment comparison at Week 24 for the groups CAB LA+ RPV LA and current ART is presented.||
1595746|NCT02951052|2934034|Non-Inferiority|Non-inferiority in the proportion of participants with HIV-1 RNA<50 c/mL at Week 48 (per FDA’s snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB – current ART) is more than -10%.|Adjusted difference in proportion|-3.0|||||2-Sided|95.0|-6.7|0.7|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).||
1595747|NCT02951052|2934035|Non-Inferiority|Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA’s snapshot algorithm for assessing HIV-1 RNA >=50 copies/mL) can be concluded if the upper bound of a two-sided 95% confidence interval for the difference in failure rates between the two treatment arms (CAB – current ART) is not more than 6%.|Adjusted difference in proportion|0.6|||||2-Sided|95.0|-1.2|2.5|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Baseline third agent (PI, NNRTI, INI).||
1595748|NCT02949271|2934101|Other|||||||0.08|||||||Chi-squared||||
1595749|NCT02949271|2934103|Other|||||||0.21|||||||Chi-squared||||
1595750|NCT02949271|2934104|Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1595751|NCT02949271|2934105|Other|||||||0.53|||||||Wilcoxon (Mann-Whitney)||||
1595752|NCT02949271|2934106|Other|||||||0.85|||||||Chi-squared||||
1595753|NCT02949271|2934107|Other|||||||0.28|||||||Chi-squared||||
1595754|NCT02949271|2934108|Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1595755|NCT02949271|2934110|Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)||||
1595756|NCT02949271|2934111|Other|||||||0.17|||||||Wilcoxon (Mann-Whitney)||||
1595757|NCT02949011|2934130|Superiority|||||||0.2558||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications|
1595758|NCT02949011|2934130|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact|||Any Complications|
1595759|NCT02949011|2934131|Superiority|||||||0.8478||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact||||
1595760|NCT02949011|2934131|Superiority|||||||0.0112||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Fisher Exact||||
1595761|NCT02949011|2934132|Superiority||Median Difference|-0.6||||0.6386||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595762|NCT02949011|2934132|Superiority||Median Difference|-23.4||||0.4634||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595763|NCT02949011|2934133|Superiority||Median Difference|-1.9||||0.371||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Fatigue|
1595764|NCT02949011|2934133|Superiority||Median Difference|-7.5||||0.0207||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Fatigue|
1595765|NCT02949011|2934133|Superiority||Median Difference|4.0||||0.5436||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Muscle or Joint Pain|
1595766|NCT02949011|2934133|Superiority||Median Difference|-7.7||||0.0232||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Muscle or Joint Pain|
1595767|NCT02949011|2934133|Superiority||Median Difference|-0.7||||0.9191||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Feverishness or Chills|
1595768|NCT02949011|2934133|Superiority||Median Difference|-3.6||||0.007||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Feverishness or Chills|
1595769|NCT02949011|2934133|Superiority||Median Difference|1.5||||0.8119||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Nasal Congestion|
1595770|NCT02949011|2934133|Superiority||Median Difference|-12.1||||0.0017||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Nasal Congestion|
1595771|NCT02949011|2934133|Superiority||Median Difference|2.0||||0.7877||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Headache|
1595772|NCT02949011|2934133|Superiority||Median Difference|-10.6||||0.039||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Headache|
1595773|NCT02949011|2934133|Superiority||Median Difference|0.9||||0.2963||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Sore Throat|
1595774|NCT02949011|2934133|Superiority||Median Difference|-6.3||||0.2496||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Sore Throat|
1595775|NCT02949011|2934133|Superiority||Median Difference|-0.2||||0.4074||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Cough|
1595776|NCT02949011|2934133|Superiority||Median Difference|-23.1||||0.0009||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Cough|
1595777|NCT02949011|2934134|Superiority||LS Mean Difference|0.05|Standard Error of the Mean|0.05||0.3577|2-Sided|95.0|-0.05|0.15||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||120 hours|
1595778|NCT02949011|2934134|Superiority||LS Mean Difference|-0.01|Standard Error of the Mean|0.05||0.803|2-Sided|95.0|-0.11|0.09||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||120 hours|
1595779|NCT02949011|2934134|Superiority||LS Mean Difference|0.02|Standard Error of the Mean|0.05||0.7498|2-Sided|95.0|-0.09|0.12||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||96 hours|
1595780|NCT02949011|2934134|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.05||0.0878|2-Sided|95.0|-0.19|0.01||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||96 hours|
1595781|NCT02949011|2934134|Superiority||LS Mean Difference|0.01|Standard Error of the Mean|0.05||0.8299|2-Sided|95.0|-0.09|0.11||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||72 hours|
1595782|NCT02949011|2934134|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.05||0.0025|2-Sided|95.0|-0.26|-0.06||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||72 hours|
1595783|NCT02949011|2934134|Superiority||LS Mean Difference|-0.06|Standard Error of the Mean|0.06||0.3185|2-Sided|95.0|-0.17|0.05||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||48 hours|
1595784|NCT02949011|2934134|Superiority||LS Mean Difference|-0.33|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.44|-0.22||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||48 hours|
1595785|NCT02949011|2934134|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.06|<|0.5414|2-Sided|95.0|-0.15|0.08||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||36 hours|
1595786|NCT02949011|2934134|Superiority||LS Mean Difference|-0.36|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.47|-0.24||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||36 hours|
1595787|NCT02949011|2934134|Superiority||LS Mean Difference|0.04|Standard Error of the Mean|0.06|<|0.4874|2-Sided|95.0|-0.08|0.16||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||24 hours|
1595788|NCT02949011|2934134|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.06|<|0.0025|2-Sided|95.0|-0.3|-0.06||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||24 hours|
1595811|NCT02949011|2934135|Superiority||||||<|0.2249||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours|
1595789|NCT02949011|2934134|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.07|<|0.5324|2-Sided|95.0|-0.18|0.09||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||12 hours|
1595790|NCT02949011|2934134|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.07|<|0.0408|2-Sided|95.0|-0.28|-0.01||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ANCOVA|ANCOVA with baseline composite symptom score, preexisting and worsened symptom, region, and body temperature at baseline as covariates.||12 hours|
1595791|NCT02949011|2934135|Superiority|||||||0.6102||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours|
1595792|NCT02949011|2934135|Superiority|||||||0.6568||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours|
1595793|NCT02949011|2934135|Superiority|||||||0.4265||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours|
1595794|NCT02949011|2934135|Superiority|||||||0.6465||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours|
1595795|NCT02949011|2934135|Superiority|||||||0.864||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours|
1595796|NCT02949011|2934135|Superiority|||||||0.7867||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours|
1595797|NCT02949011|2934135|Superiority|||||||0.3328||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours|
1595798|NCT02949011|2934135|Superiority|||||||0.1041||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours|
1595799|NCT02949011|2934135|Superiority|||||||0.3773||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours|
1595800|NCT02949011|2934135|Superiority|||||||0.8167||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours|
1595801|NCT02949011|2934135|Superiority|||||||0.6746||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours|
1595802|NCT02949011|2934135|Superiority|||||||0.0064||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours|
1595803|NCT02949011|2934135|Superiority|||||||0.5923||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours|
1595804|NCT02949011|2934135|Superiority|||||||0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours|
1595805|NCT02949011|2934135|Superiority|||||||0.8808||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours|
1595806|NCT02949011|2934135|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours|
1595807|NCT02949011|2934135|Superiority||||||<|0.2617||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours|
1595808|NCT02949011|2934135|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours|
1595809|NCT02949011|2934135|Superiority||||||<|0.3915||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours|
1595810|NCT02949011|2934135|Superiority||||||<|0.0387||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours|
1596983|NCT02932306|2934935|Superiority||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.|
1595812|NCT02949011|2934135|Superiority||||||<|0.1713||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours|
1595813|NCT02949011|2934136|Superiority||Median Difference|-3.5||||0.2425|2-Sided|95.0|-9.1|2.7||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595814|NCT02949011|2934136|Superiority||Median Difference|-19.8|||<|0.0001|2-Sided|95.0|-28.8|-12.5||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595815|NCT02949011|2934137|Superiority||Median Difference|1.5||||0.9237||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595816|NCT02949011|2934137|Superiority||Median Difference|-24.1||||0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595817|NCT02949011|2934138|Superiority||Median Difference|2.3||||0.8498||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595818|NCT02949011|2934138|Superiority||Median Difference|-15.1||||0.0013||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595819|NCT02949011|2934139|Superiority||Median Difference|-8.6||||0.9127||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595820|NCT02949011|2934139|Superiority||Median Difference|-25.8|||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595821|NCT02949011|2934140|Superiority|||||||0.4024||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours|
1595822|NCT02949011|2934140|Superiority|||||||0.0708||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||216 hours|
1595823|NCT02949011|2934140|Superiority|||||||0.4931||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours|
1595824|NCT02949011|2934140|Superiority|||||||0.0644||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||192 hours|
1595825|NCT02949011|2934140|Superiority|||||||0.7448||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours|
1595826|NCT02949011|2934140|Superiority|||||||0.0209||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||168 hours|
1595827|NCT02949011|2934140|Superiority|||||||0.7425||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours|
1595828|NCT02949011|2934140|Superiority|||||||0.0081||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||144 hours|
1595829|NCT02949011|2934140|Superiority|||||||0.9635||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours|
1595830|NCT02949011|2934140|Superiority|||||||0.0274||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||120 hours|
1595831|NCT02949011|2934140|Superiority|||||||0.186||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours|
1595832|NCT02949011|2934140|Superiority|||||||0.0012||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||96 hours|
1595833|NCT02949011|2934140|Superiority|||||||0.9547||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours|
1595834|NCT02949011|2934140|Superiority|||||||0.0002||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||72 hours|
1595835|NCT02949011|2934140|Superiority|||||||0.6234||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours|
1595836|NCT02949011|2934140|Superiority|||||||0.0072||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||48 hours|
1595837|NCT02949011|2934140|Superiority|||||||0.5625||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours|
1595838|NCT02949011|2934140|Superiority|||||||0.0004||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||36 hours|
1595839|NCT02949011|2934140|Superiority|||||||0.6483||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours|
1595840|NCT02949011|2934140|Superiority|||||||0.1112||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||24 hours|
1595841|NCT02949011|2934140|Superiority|||||||0.5777||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours|
1595842|NCT02949011|2934140|Superiority|||||||0.7698||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel-Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||12 hours|
1595843|NCT02949011|2934141|Superiority||Median Difference|0.0||||0.237|2-Sided|95.0|-48.0|24.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region|||
1595844|NCT02949011|2934141|Superiority||Median Difference|-24.0||||0.0006|2-Sided|95.0|-96.0|0.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region|||
1595845|NCT02949011|2934142|Superiority||Median Difference|-48.0|||<|0.0001|2-Sided|95.0|-48.0|-24.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region|||
1595846|NCT02949011|2934142|Superiority||Median Difference|-48.0|||<|0.0001|2-Sided|95.0|-48.0|-48.0||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region|||
1595847|NCT02949011|2934143|Superiority|||||||0.733||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595848|NCT02949011|2934143|Superiority|||||||0.0072||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595849|NCT02949011|2934144|Superiority|||||||0.2766||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595850|NCT02949011|2934144|Superiority|||||||0.034||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.|||
1595851|NCT02949011|2934145|Superiority|||||||0.6156||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9|
1595852|NCT02949011|2934145|Superiority|||||||0.7624||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9|
1595853|NCT02949011|2934145|Superiority|||||||0.9075||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6|
1595854|NCT02949011|2934145|Superiority|||||||0.9554||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6|
1595855|NCT02949011|2934145|Superiority|||||||0.5298||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5|
1596984|NCT02931396|2934948|Superiority||Mean Difference (Net)|2.7||||0.03|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1596985|NCT02931396|2934949|Superiority||Mean Difference (Net)|25.5||||1|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1595856|NCT02949011|2934145|Superiority|||||||0.0247||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5|
1595857|NCT02949011|2934145|Superiority|||||||0.0265||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4|
1595858|NCT02949011|2934145|Superiority|||||||0.0028||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4|
1595859|NCT02949011|2934145|Superiority|||||||0.0015||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3|
1595860|NCT02949011|2934145|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3|
1595861|NCT02949011|2934145|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2|
1595862|NCT02949011|2934145|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2|
1595863|NCT02949011|2934146|Superiority|||||||0.1281||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9|
1595864|NCT02949011|2934146|Superiority|||||||0.0266||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9|
1595865|NCT02949011|2934146|Superiority|||||||0.4677||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6|
1595866|NCT02949011|2934146|Superiority|||||||0.0543||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6|
1595867|NCT02949011|2934146|Superiority|||||||0.5466||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5|
1595868|NCT02949011|2934146|Superiority|||||||0.5739||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5|
1595869|NCT02949011|2934146|Superiority|||||||0.5361||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4|
1595870|NCT02949011|2934146|Superiority|||||||0.9127||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|ven Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4|
1595871|NCT02949011|2934146|Superiority|||||||0.0024||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3|
1595872|NCT02949011|2934146|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3|
1595873|NCT02949011|2934146|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2|
1595874|NCT02949011|2934146|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|van Elteren test|Van Elteren test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2|
1595875|NCT02949011|2934147|Superiority|||||||0.3068||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9|
1595876|NCT02949011|2934147|Superiority|||||||0.0017||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9|
1595877|NCT02949011|2934147|Superiority|||||||0.9106||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6|
1595878|NCT02949011|2934147|Superiority|||||||0.3087||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6|
1595879|NCT02949011|2934147|Superiority|||||||0.5547||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5|
1595880|NCT02949011|2934147|Superiority|||||||0.0784||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5|
1595881|NCT02949011|2934147|Superiority|||||||0.9603||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4|
1595882|NCT02949011|2934147|Superiority|||||||0.3071||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4|
1595883|NCT02949011|2934147|Superiority|||||||0.1237||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3|
1595884|NCT02949011|2934147|Superiority|||||||0.0576||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3|
1595885|NCT02949011|2934147|Superiority|||||||0.9619||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2|
1595886|NCT02949011|2934147|Superiority|||||||0.7383||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2|
1595887|NCT02949011|2934148|Superiority|||||||0.0907||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9|
1595888|NCT02949011|2934148|Superiority|||||||0.0929||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 9|
1595889|NCT02949011|2934148|Superiority|||||||0.441||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6|
1595890|NCT02949011|2934148|Superiority|||||||0.0046||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 6|
1595891|NCT02949011|2934148|Superiority|||||||0.1146||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5|
1595892|NCT02949011|2934148|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 5|
1595893|NCT02949011|2934148|Superiority||||||<|0.0044||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4|
1595894|NCT02949011|2934148|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 4|
1595895|NCT02949011|2934148|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3|
1595896|NCT02949011|2934148|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 3|
1595897|NCT02949011|2934148|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2|
1595898|NCT02949011|2934148|Superiority||||||<|0.0001||||||The p value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Mantel Haenszel|Mantel Haenszel test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Day 2|
1595899|NCT02949011|2934149|Superiority|||||||0.8449||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Analysis using the stratified log rank test was performed as a sensitivity analysis.|
1595900|NCT02949011|2934149|Superiority|||||||0.0008||||||The p-value was not adjusted for multiplicity, testing was conducted at the two-sided significance level of 0.05.|Log Rank|Log rank test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||Analysis using the stratified log rank test was performed as a sensitivity analysis.|
1595901|NCT02949011|2934149|Superiority||Median Difference|-7.7||||0.8347|2-Sided|95.0|-22.7|7.9||Adjusted p-value, two-sided significance level of 0.05|Stratified generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||The comparison between the baloxavir marboxil and the oseltamivir groups was conducted as a secondary analysis only if a statistically significant difference was observed in the primary analysis in order to maintain control of overall type I error.|
1596986|NCT02931396|2934950|Superiority||Mean Difference (Net)|2.3||||0.768|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1620538|NCT02314923|2977569|Other||||||<|0.001|||||||ANOVA||||
1595902|NCT02949011|2934149|Superiority||Median Difference|-29.1|||<|0.0001|2-Sided|95.0|-42.8|-14.6||Adjusted p-value, two-sided significance level of 0.05|Stratified generalized Wilcoxon test|Peto-Prentice’s generalized Wilcoxon test stratified by baseline composite symptom score, preexisting and worsened symptoms, and region.||The primary analysis of the primary endpoint was a comparison between the baloxavir marboxil and placebo groups.|
1595903|NCT02948634|2934150|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1595904|NCT02948634|2934151|Superiority|||||||0.32|||||||ANOVA||||
1595905|NCT02948634|2934152|Superiority|||||||0.43|||||||ANOVA||||
1595906|NCT02948582|2934165|Superiority||least squares mean|0.128|||<|0.0001|2-Sided|95.0|0.091|0.166|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.|
1595907|NCT02948582|2934165|Superiority||least squares mean|0.135|||<|0.0001|2-Sided|95.0|0.098|0.173|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.|
1595908|NCT02948582|2934165|Superiority||least squares mean|0.105|||<|0.0001|2-Sided|95.0|0.068|0.142|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.|
1595909|NCT02948582|2934165|Superiority||least squares mean|0.1|||<|0.0001|2-Sided|95.0|0.063|0.137|||least squares mena|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.|
1595910|NCT02948582|2934165|Superiority||least squares mean|0.058|||<|0.0028|2-Sided|95.0|0.021|0.095|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC12_24 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.|
1595911|NCT02948582|2934166|Superiority||least squares mean|0.199|||<|0.0001|2-Sided|95.0|0.162|0.235|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.|
1595912|NCT02948582|2934166|Superiority||least squares mean|0.202|||<|0.0001|2-Sided|95.0|0.165|0.239|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.|
1595913|NCT02948582|2934166|Superiority||least squares mean|0.156|||<|0.0001|2-Sided|95.0|0.12|0.193|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.|
1595914|NCT02948582|2934166|Superiority||least squares mean|0.151|||<|0.0001|2-Sided|95.0|0.114|0.187|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.|
1595915|NCT02948582|2934166|Superiority||least squares mean|0.086|||<|0.0001|2-Sided|95.0|0.05|0.123|||least squares mean|||An analysis of covariance was used with change from baseline in standardized FEV1 AUC0_12 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.|
1595916|NCT02948582|2934167|Superiority||least squares mean|0.098|||<|0.0001|2-Sided|95.0|0.056|0.14|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."|
1595917|NCT02948582|2934167|Superiority||least squares mean|0.108|||<|0.0001|2-Sided|95.0|0.066|0.15|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."|
1595918|NCT02948582|2934167|Superiority||least squares mean|0.102|||<|0.0001|2-Sided|95.0|0.061|0.144|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."|
1595919|NCT02948582|2934167|Superiority||least squares mean|0.072|||<|0.0008|2-Sided|95.0|0.03|0.113|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."|
1595949|NCT02942017|2934352|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|1.149||0.7852|2-Sided|95.0|-2.6|1.97|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595920|NCT02948582|2934167|Superiority||least squares mean|0.033|||<|0.1257|2-Sided|95.0|-0.009|0.075|||least squares mean|||"An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence.~A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2."|
1595921|NCT02947984|2934179|Other|||||||0.061|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the sub-group receiving treatment due to recurrent disease|
1595922|NCT02947984|2934179|Other|||||||0.82|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the subgroup receiving treatment due to a sub-total resection|
1595923|NCT02947984|2934179|Other|||||||0.234|||||||Log Rank|||Null hypothesis: Progression free survival is not significantly different by dose level in the overall cohort.|
1595924|NCT02946463|2934205|Non-Inferiority|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -20%.|Treatment difference|2.9|||||2-Sided|95.0|-8.8|14.64|||||Treatment difference was estimated for ravulizumab - eculizumab.|The difference of percentages was calculated using stratified Newcombe CI method. The stratification factors were: observed stratification groups of pRBC units transfused in the 1 year prior to first dose of study drug and screening LDH levels.|
1595925|NCT02946463|2934206|Non-Inferiority|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -5%.|Treatment difference|0.67|||||2-Sided|95.0|-1.21|2.55|||||Treatment difference was estimated for ravulizumab - eculizumab.||
1595926|NCT02946463|2934207|Non-Inferiority|Noninferiority margin was based on the upper bound of the 95% CI. Noninferiority margin was 20%.|Treatment difference|-0.83|||||2-Sided|95.0|-5.21|3.56|||||Treatment difference was estimated for ravulizumab - eculizumab.||
1595927|NCT02946463|2934208|Non-Inferiority|Noninferiority margin was based on the upper bound of the 95% CI. Noninferiority margin was 20%.|Treatment difference|-6.7|||||2-Sided|95.0|-14.21|0.18|||||Treatment difference was estimated for ravulizumab - eculizumab.|The difference of percentages was calculated using stratified Newcombe CI method. The stratification factors were: observed stratification groups of pRBC units transfused in the 1 year prior to first dose of study drug and screening LDH levels.|
1595928|NCT02946463|2934209|Non-Inferiority|Noninferiority margin was based on the lower bound of the 95% CI. Noninferiority margin was -20%.|Treatment difference|6.8|||||2-Sided|95.0|-4.66|18.14|||||Treatment difference was estimated for ravulizumab - eculizumab.|A minimum of 193 participants were estimated to provide 80% power to demonstrate noninferiority of ravulizumab to eculizumab. The difference of percentages were calculated using stratified Newcombe CI method. Stratification factors were: observed stratification groups of packed red blood cells (pRBC)/whole blood units transfused in the 1 year prior to first dose of study drug and screening LDH levels.|
1595929|NCT02946463|2934210|Non-Inferiority|"LDH-N was analyzed using a generalized estimating equation (GEE) approach. The model included the following terms: treatment group, history of transfusion (as a categorical variable based on the stratification factor levels), and baseline LDH level (as a continuous variable).~Noninferiority margin was based on the lower bound of the 95% confidence interval (CI) for the odds ratio (OR) of ravulizumab versus eculizumab for LDH normalization being greater than an OR of 0.39."|Odds Ratio (OR)|1.187|||||2-Sided|95.0|0.796|1.769||||||A minimum of 142 participants were estimated to provide 80% power to demonstrate noninferiority of ravulizumab to eculizumab.|
1595930|NCT02945254|2934257|Superiority|||||||0.13||||||P<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)||||
1595931|NCT02945254|2934258|Superiority|||||||0.011||||||P<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)||||
1595932|NCT02945046|2934276|Other||LS mean difference|-1.9|Standard Error of the Mean|1.29||0.1345|2-Sided|95.0|-4.49|0.61||Threshold for significance at 0.05 level.|ANCOVA||||
1595933|NCT02945046|2934276|Other||LS mean difference|-0.1|Standard Error of the Mean|1.3||0.9093|2-Sided|95.0|-2.72|2.42||Threshold for significance at 0.05 level.|ANCOVA||||
1595934|NCT02943941|2934304|Other||||||<|0.001|||||||ANOVA||||
1595935|NCT02943941|2934305|Other|||||||0.059||||||Pressure during coughing versus normal breathing initially measured at baseline.|ANOVA||||
1595936|NCT02943941|2934306|Other|||||||0.429|||||||ANOVA||||
1595937|NCT02943577|2934307|Superiority||Least Squares Mean Difference|0.5||||0.5563|2-Sided|95.0|-1.17|2.17|||Mixed Model Repeated Measures (MMRM)||||
1595938|NCT02943577|2934308|Superiority||Least Squares Mean Difference|0.0||||0.9901|2-Sided|95.0|-2.01|1.99|||Mixed Model Repeated Measures (MMRM)||||
1595939|NCT02943577|2934309|Superiority||Least Squares Mean Difference|0.4||||0.5522|2-Sided|95.0|-0.95|1.77|||Mixed Model Repeated Measures (MMRM)||||
1595940|NCT02943577|2934310|Superiority||Least Squares Mean Difference|-1.0||||0.2398|2-Sided|95.0|-2.7|0.68|||Mixed Model Repeated Measures (MMRM)||||
1595941|NCT02943564|2934311|Superiority||Least Squares Mean Difference|0.0||||0.9963|2-Sided|95.0|-1.38|1.39|||Mixed Model Repeated Measures (MMRM)||||
1595942|NCT02943564|2934311|Superiority||Least Squares Mean Difference|-0.1||||0.8967|2-Sided|95.0|-1.48|1.29|||Mixed Model Repeated Measures (MMRM)||||
1595943|NCT02943564|2934312|Superiority||Least Squares Mean Difference|-0.5||||0.5772|2-Sided|95.0|-2.07|1.16|||Mixed Model Repeated Measures (MMRM)||||
1595944|NCT02943564|2934312|Superiority||Least Squares Mean Difference|0.1||||0.8862|2-Sided|95.0|-1.5|1.73|||Mixed Model Repeated Measures (MMRM)||||
1595945|NCT02943499|2934313|Superiority|||||||0.92|||||||t-test, 2 sided|||To examine between-group differences in pre- vs. post-treatment cue reactivity, the post-treatment PCC BOLD response for the smoking vs neutral contrast was subtracted from the baseline response. The groups were then compared directly on this measure using a t-test.|
1595946|NCT02943226|2934321|Superiority|||||||0.0784|||||||two sample t-test||||
1595947|NCT02943226|2934322|Superiority|||||||0.0112|||||||Wilcoxon (Mann-Whitney)||||
1595948|NCT02943226|2934323|Superiority|||||||0.4487|||||||two sample t-test||||
1597013|NCT02926573|2935232|Superiority||Mean Difference (Final Values)|7.4|||||2-Sided|95.0|-3.6|18.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.||
1595950|NCT02942017|2934352|Superiority||LS Mean Difference|-1.95|Standard Error of the Mean|1.408||0.1691|2-Sided|95.0|-4.76|0.85|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595951|NCT02942017|2934352|Superiority||LS Mean Difference|-1.86|Standard Error of the Mean|1.227||0.1341|2-Sided|95.0|-4.3|0.59|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595952|NCT02942017|2934352|Superiority||LS Mean Difference|-0.76|Standard Error of the Mean|1.103||0.4897|2-Sided|95.0|-2.96|1.43|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595953|NCT02942017|2934352|Superiority||LS Mean Difference|-1.17|Standard Error of the Mean|1.041||0.2636|2-Sided|95.0|-3.24|0.9|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595954|NCT02942017|2934353|Superiority||Odds Ratio (OR)|1.5||||0.4399|2-Sided|95.0|0.5|4.6|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.|
1595955|NCT02942017|2934353|Superiority||Odds Ratio (OR)|2.9||||0.0478|2-Sided|95.0|1.0|8.4|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.|
1595956|NCT02942017|2934353|Superiority||Odds Ratio (OR)|5.0||||0.0005|2-Sided|95.0|2.0|12.5|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.|
1595957|NCT02942017|2934354|Superiority||LS mean difference|0.04|Standard Error of the Mean|1.884||0.9845|2-Sided|95.0|-3.72|3.79|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595958|NCT02942017|2934354|Superiority||LS mean difference|-3.56|Standard Error of the Mean|2.154||0.1017|2-Sided|95.0|-7.84|0.72|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595959|NCT02942017|2934354|Superiority||LS mean difference|-4.86|Standard Error of the Mean|1.612||0.0033|2-Sided|95.0|-8.06|-1.66|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595960|NCT02942017|2934355|Superiority||LS Mean Difference|0.01|Standard Error of the Mean|0.046||0.8263|2-Sided|95.0|-0.08|0.1|||MMRM|||Insight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595961|NCT02942017|2934355|Superiority||LS Mean Difference|-0.01|Standard Error of the Mean|0.051||0.9087|2-Sided|95.0|-0.11|0.09|||MMRM|||Insight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595962|NCT02942017|2934355|Superiority||LS Mean Difference|-0.02|Standard Error of the Mean|0.051||0.6622|2-Sided|95.0|-0.12|0.08|||MMRM|||Insight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595963|NCT02942017|2934355|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.045||0.3417|2-Sided|95.0|-0.13|0.05|||MMRM|||Insight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595964|NCT02942017|2934355|Superiority||LS Mean Difference|0.02|Standard Error of the Mean|0.045||0.6664|2-Sided|95.0|-0.07|0.11|||MMRM|||Insight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595965|NCT02942017|2934355|Superiority||LS Mean Difference|0.06|Standard Error of the Mean|0.046||0.2031|2-Sided|95.0|-0.03|0.15|||MMRM|||Insight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595966|NCT02942017|2934355|Superiority||LS Mean Difference|0.02|Standard Error of the Mean|0.045||0.6672|2-Sided|95.0|-0.07|0.11|||MMRM|||Insight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595967|NCT02942017|2934355|Superiority||LS Mean Difference|0.0|Standard Error of the Mean|0.045||0.9859|2-Sided|95.0|-0.09|0.09|||MMRM|||Insight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595968|NCT02942017|2934355|Superiority||LS Mean Difference|-0.06|Standard Error of the Mean|0.045||0.1827|2-Sided|95.0|-0.15|0.03|||MMRM|||Insight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595969|NCT02942017|2934355|Superiority||LS Mean Difference|-0.02|Standard Error of the Mean|0.045||0.6436|2-Sided|95.0|-0.11|0.07|||MMRM|||Insight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595970|NCT02942017|2934355|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.045||0.0826|2-Sided|95.0|-0.17|0.01|||MMRM|||Insight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595971|NCT02942017|2934355|Superiority||LS Mean Difference|-0.06|Standard Error of the Mean|0.045||0.1818|2-Sided|95.0|-0.15|0.03|||MMRM|||Insight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595972|NCT02942017|2934355|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.045||0.3675|2-Sided|95.0|-0.13|0.05|||MMRM|||Insight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595973|NCT02942017|2934355|Superiority||LS Mean Difference|0.03|Standard Error of the Mean|0.156||0.8274|2-Sided|95.0|-0.28|0.34|||MMRM|||Loss of Weight, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595974|NCT02942017|2934355|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.182||0.5085|2-Sided|95.0|-0.48|0.24|||MMRM|||Loss of Weight, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595975|NCT02942017|2934355|Superiority||LS Mean Difference|0.05|Standard Error of the Mean|0.174||0.7812|2-Sided|95.0|-0.3|0.4|||MMRM|||Loss of Weight, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595976|NCT02942017|2934355|Superiority||LS Mean Difference|0.2|Standard Error of the Mean|0.125||0.1176|2-Sided|95.0|-0.05|0.44|||MMRM|||Loss of Weight, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1620539|NCT02314923|2977569|Other||||||<|0.065|||||||ANOVA||||
1595977|NCT02942017|2934355|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.102||0.4352|2-Sided|95.0|-0.28|0.12|||MMRM|||Loss of Weight, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595978|NCT02942017|2934355|Superiority||LS Mean Difference|0.01|Standard Error of the Mean|0.085||0.9492|2-Sided|95.0|-0.16|0.17|||MMRM|||Loss of Weight, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595979|NCT02942017|2934355|Superiority||LS Mean Difference|0.12|Standard Error of the Mean|0.1||0.2358|2-Sided|95.0|-0.08|0.32|||MMRM|||Loss of Weight, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595980|NCT02942017|2934355|Superiority||LS Mean Difference|0.08|Standard Error of the Mean|0.088||0.361|2-Sided|95.0|-0.09|0.26|||MMRM|||Loss of Weight, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595981|NCT02942017|2934355|Superiority||LS Mean Difference|0.2|Standard Error of the Mean|0.088||0.0233|2-Sided|95.0|0.03|0.38|||MMRM|||Loss of Weight, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595982|NCT02942017|2934355|Superiority||LS Mean Difference|0.18|Standard Error of the Mean|0.088||0.0408|2-Sided|95.0|0.01|0.36|||MMRM|||Loss of Weight, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595983|NCT02942017|2934355|Superiority||LS Mean Difference|0.11|Standard Error of the Mean|0.066||0.1054|2-Sided|95.0|-0.02|0.24|||MMRM|||Loss of Weight, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595984|NCT02942017|2934355|Superiority||LS Mean Difference|0.15|Standard Error of the Mean|0.081||0.0717|2-Sided|95.0|-0.01|0.31|||MMRM|||Loss of weight, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595985|NCT02942017|2934355|Superiority||LS Mean Difference|0.05|Standard Error of the Mean|0.069||0.4493|2-Sided|95.0|-0.08|0.19|||MMRM|||Loss of weight, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595986|NCT02942017|2934355|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.09||0.3297|2-Sided|95.0|-0.27|0.09|||MMRM|||Hypochondriasis, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595987|NCT02942017|2934355|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.126||0.7128|2-Sided|95.0|-0.3|0.21|||MMRM|||Hypochondriasis, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595988|NCT02942017|2934355|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.14||0.2101|2-Sided|95.0|-0.48|0.11|||MMRM|||Hypochondriasis, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595989|NCT02942017|2934355|Superiority||LS Mean Difference|-0.02|Standard Error of the Mean|0.119||0.8654|2-Sided|95.0|-0.26|0.22|||MMRM|||Hypochondriasis, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595990|NCT02942017|2934355|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.102||0.6472|2-Sided|95.0|-0.25|0.16|||MMRM|||Hypochondriasis, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595991|NCT02942017|2934355|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.099||0.6673|2-Sided|95.0|-0.24|0.15|||MMRM|||Hypochondriasis, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595992|NCT02942017|2934355|Superiority||LS Mean Difference|0.05|Standard Error of the Mean|0.099||0.6031|2-Sided|95.0|-0.14|0.25|||MMRM|||Hypochondriasis, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595993|NCT02942017|2934355|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.106||0.6794|2-Sided|95.0|-0.25|0.17|||MMRM|||Hypochondriasis, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595994|NCT02942017|2934355|Superiority||LS Mean Difference|0.05|Standard Error of the Mean|0.089||0.5811|2-Sided|95.0|-0.13|0.23|||MMRM|||Hypochondriasis, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595995|NCT02942017|2934355|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.1||0.1113|2-Sided|95.0|-0.36|0.04|||MMRM|||Hypochondriasis, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595996|NCT02942017|2934355|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.095||0.6694|2-Sided|95.0|-0.23|0.15|||MMRM|||Hypochondriasis, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595997|NCT02942017|2934355|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.093||0.3946|2-Sided|95.0|-0.26|0.1|||MMRM|||Hypochondriasis, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595998|NCT02942017|2934355|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.101||0.1279|2-Sided|95.0|-0.36|0.05|||MMRM|||Hypochondriasis, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1595999|NCT02942017|2934355|Superiority||LS Mean Difference|0.22|Standard Error of the Mean|0.186||0.2465|2-Sided|95.0|-0.15|0.58|||MMRM|||Genital Symptoms, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596000|NCT02942017|2934355|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.207||0.6877|2-Sided|95.0|-0.5|0.33|||MMRM|||Genital Symptoms, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596001|NCT02942017|2934355|Superiority||LS Mean Difference|-0.1|Standard Error of the Mean|0.21||0.6311|2-Sided|95.0|-0.52|0.32|||MMRM|||Genital Symptoms, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596002|NCT02942017|2934355|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.158||0.772|2-Sided|95.0|-0.36|0.27|||MMRM|||Genital Symptoms, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596003|NCT02942017|2934355|Superiority||LS Mean Difference|-0.37|Standard Error of the Mean|0.143||0.011|2-Sided|95.0|-0.66|-0.09|||MMRM|||Genital Symptoms, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596004|NCT02942017|2934355|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.116||0.2541|2-Sided|95.0|-0.36|0.1|||MMRM|||Genital Symptoms, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596005|NCT02942017|2934355|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.128||0.1123|2-Sided|95.0|-0.46|0.05|||MMRM|||Genital Symptoms, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596006|NCT02942017|2934355|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.127||0.328|2-Sided|95.0|-0.38|0.13|||MMRM|||Genital Symptoms, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596007|NCT02942017|2934355|Superiority||LS Mean Difference|-0.02|Standard Error of the Mean|0.123||0.8861|2-Sided|95.0|-0.26|0.23|||MMRM|||Genital Symptoms, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596008|NCT02942017|2934355|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.115||0.752|2-Sided|95.0|-0.26|0.19|||MMRM|||Genital Symptoms, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596009|NCT02942017|2934355|Superiority||LS Mean Difference|0.04|Standard Error of the Mean|0.094||0.6531|2-Sided|95.0|-0.14|0.23|||MMRM|||Genital Symptoms, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596010|NCT02942017|2934355|Superiority||LS Mean Difference|0.08|Standard Error of the Mean|0.087||0.3545|2-Sided|95.0|-0.09|0.25|||MMRM|||Genital Symptoms, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596011|NCT02942017|2934355|Superiority||LS Mean Difference|0.12|Standard Error of the Mean|0.067||0.0748|2-Sided|95.0|-0.01|0.26|||MMRM|||Genital Symptoms, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596012|NCT02942017|2934355|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.141||0.5513|2-Sided|95.0|-0.36|0.2|||MMRM|||Somatic Symptoms General, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596013|NCT02942017|2934355|Superiority||LS Mean Difference|0.15|Standard Error of the Mean|0.169||0.3721|2-Sided|95.0|-0.18|0.49|||MMRM|||Somatic Symptoms General, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596014|NCT02942017|2934355|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.16||0.0889|2-Sided|95.0|-0.59|0.04|||MMRM|||Somatic Symptoms General, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596683|NCT02942004|2934370|Superiority||Odds Ratio (OR)|2.6||||0.0493|2-Sided|95.0|1.0|6.9|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.|
1596015|NCT02942017|2934355|Superiority||LS Mean Difference|-0.36|Standard Error of the Mean|0.138||0.0108|2-Sided|95.0|-0.63|-0.08|||MMRM|||Somatic Symptoms General, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596016|NCT02942017|2934355|Superiority||LS Mean Difference|-0.25|Standard Error of the Mean|0.153||0.099|2-Sided|95.0|-0.56|0.05|||MMRM|||Somatic Symptoms General, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596017|NCT02942017|2934355|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.141||0.4061|2-Sided|95.0|-0.4|0.16|||MMRM|||Somatic Symptoms General, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596018|NCT02942017|2934355|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.136||0.5389|2-Sided|95.0|-0.35|0.19|||MMRM|||Somatic Symptoms General, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596019|NCT02942017|2934355|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.13||0.2942|2-Sided|95.0|-0.4|0.12|||MMRM|||Somatic Symptoms General, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596020|NCT02942017|2934355|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.14||0.5691|2-Sided|95.0|-0.36|0.2|||MMRM|||Somatic Symptoms General, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596021|NCT02942017|2934355|Superiority||LS Mean Difference|-0.25|Standard Error of the Mean|0.123||0.0457|2-Sided|95.0|-0.49|0.0|||MMRM|||Somatic Symptoms General, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596022|NCT02942017|2934355|Superiority||LS Mean Difference|-0.06|Standard Error of the Mean|0.123||0.6094|2-Sided|95.0|-0.31|0.18|||MMRM|||Somatic Symptoms General, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596023|NCT02942017|2934355|Superiority||LS Mean Difference|-0.06|Standard Error of the Mean|0.126||0.6362|2-Sided|95.0|-0.31|0.19|||MMRM|||Somatic Symptoms General, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596024|NCT02942017|2934355|Superiority||LS Mean Difference|0.02|Standard Error of the Mean|0.103||0.8224|2-Sided|95.0|-0.18|0.23|||MMRM|||Somatic Symptoms General, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596025|NCT02942017|2934355|Superiority||LS Mean Difference|0.04|Standard Error of the Mean|0.114||0.7211|2-Sided|95.0|-0.19|0.27|||MMRM|||Somatic Symptoms Gastrointestinal, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596026|NCT02942017|2934355|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.145||0.1422|2-Sided|95.0|-0.51|0.07|||MMRM|||Somatic Symptoms Gastrointestinal, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596751|NCT02940886|2934398|Superiority|||||||0.3913|||||||Log Rank|||The time to first adjudicated and confirmed composite cardiovascular AEs was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a log-rank test.|
1598435|NCT02900378|2936703|Other|||||||0.7908|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5|
1596027|NCT02942017|2934355|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.125||0.2153|2-Sided|95.0|-0.41|0.09|||MMRM|||Somatic Symptoms Gastrointestinal, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596028|NCT02942017|2934355|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.126||0.1087|2-Sided|95.0|-0.45|0.05|||MMRM|||Somatic Symptoms Gastrointestinal, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596029|NCT02942017|2934355|Superiority||LS Mean Difference|0.02|Standard Error of the Mean|0.107||0.8621|2-Sided|95.0|-0.19|0.23|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596030|NCT02942017|2934355|Superiority||LS Mean Difference|0.02|Standard Error of the Mean|0.122||0.8732|2-Sided|95.0|-0.22|0.26|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596031|NCT02942017|2934355|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|0.115||0.7984|2-Sided|95.0|-0.26|0.2|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596032|NCT02942017|2934355|Superiority||LS Mean Difference|0.09|Standard Error of the Mean|0.112||0.4241|2-Sided|95.0|-0.13|0.31|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596033|NCT02942017|2934355|Superiority||LS Mean Difference|-0.06|Standard Error of the Mean|0.109||0.5807|2-Sided|95.0|-0.28|0.16|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596034|NCT02942017|2934355|Superiority||LS Mean Difference|0.11|Standard Error of the Mean|0.12||0.3588|2-Sided|95.0|-0.13|0.35|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596035|NCT02942017|2934355|Superiority||LS Mean Difference|0.19|Standard Error of the Mean|0.116||0.1006|2-Sided|95.0|-0.04|0.42|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596036|NCT02942017|2934355|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.129||0.6754|2-Sided|95.0|-0.31|0.2|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596037|NCT02942017|2934355|Superiority||LS Mean Difference|0.07|Standard Error of the Mean|0.122||0.58|2-Sided|95.0|-0.18|0.31|||MMRM|||Somatic Symptoms Gastrointestinal, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596038|NCT02942017|2934355|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.149||0.5911|2-Sided|95.0|-0.38|0.22|||MMRM|||Anxiety Somatic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596752|NCT02940886|2934399|Superiority|||||||0.5695|||||||Fisher Exact|||Adjudicated and confirmed treatment-emergent composite cardiovascular AEs. Any treatment emergent composite cardiovascular AEs were included in the statistical evaluation. The overall incidence of adjudicated and confirmed composite cardiovascular AEs was tabulated and compared between the treatment groups by a Fisher’s exact test.|
1596039|NCT02942017|2934355|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.16||0.5026|2-Sided|95.0|-0.43|0.21|||MMRM|||Anxiety Somatic, day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596040|NCT02942017|2934355|Superiority||LS Mean Difference|0.22|Standard Error of the Mean|0.189||0.2522|2-Sided|95.0|-0.16|0.6|||MMRM|||Anxiety Somatic, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596041|NCT02942017|2934355|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.152||0.0847|2-Sided|95.0|-0.57|0.04|||MMRM|||Anxiety Somatic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596042|NCT02942017|2934355|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.114||0.045|2-Sided|95.0|-0.46|-0.01|||MMRM|||Anxiety Somatic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596043|NCT02942017|2934355|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.135||0.5873|2-Sided|95.0|-0.34|0.2|||MMRM|||Anxiety Somatic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596044|NCT02942017|2934355|Superiority||LS Mean Difference|-0.17|Standard Error of the Mean|0.134||0.211|2-Sided|95.0|-0.44|0.1|||MMRM|||Anxiety Somatic, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596045|NCT02942017|2934355|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.13||0.2689|2-Sided|95.0|-0.4|0.11|||MMRM|||Anxiety Somatic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596046|NCT02942017|2934355|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.138||0.7622|2-Sided|95.0|-0.32|0.23|||MMRM|||Anxiety Somatic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596047|NCT02942017|2934355|Superiority||LS Mean Difference|-0.27|Standard Error of the Mean|0.132||0.0424|2-Sided|95.0|-0.53|-0.01|||MMRM|||Anxiety Somatic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596048|NCT02942017|2934355|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.136||0.6041|2-Sided|95.0|-0.34|0.2|||MMRM|||Anxiety Somatic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596049|NCT02942017|2934355|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.13||0.4716|2-Sided|95.0|-0.35|0.16|||MMRM|||Anxiety Somatic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596050|NCT02942017|2934355|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.133||0.6117|2-Sided|95.0|-0.33|0.2|||MMRM|||Anxiety Somatic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596051|NCT02942017|2934355|Superiority||LS Mean Difference|0.15|Standard Error of the Mean|0.182||0.4032|2-Sided|95.0|-0.21|0.51|||MMRM|||Anxiety Psychic, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596052|NCT02942017|2934355|Superiority||LS Mean Difference|0.12|Standard Error of the Mean|0.209||0.5795|2-Sided|95.0|-0.3|0.53|||MMRM|||Anxiety Psychic, Day 21 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596053|NCT02942017|2934355|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.244||0.8253|2-Sided|95.0|-0.54|0.43|||MMRM|||Anxiety Psychic, Day 14 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596054|NCT02942017|2934355|Superiority||LS Mean Difference|-0.51|Standard Error of the Mean|0.173||0.004|2-Sided|95.0|-0.86|-0.17|||MMRM|||Anxiety Psychic, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596055|NCT02942017|2934355|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.177||0.1116|2-Sided|95.0|-0.63|0.07|||MMRM|||Anxiety Psychic, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596056|NCT02942017|2934355|Superiority||LS Mean Difference|-0.52|Standard Error of the Mean|0.171||0.003|2-Sided|95.0|-0.86|-0.18|||MMRM|||Anxiety Psychic, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596057|NCT02942017|2934355|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|0.187||0.0963|2-Sided|95.0|-0.69|0.06|||MMRM|||Anxiety Psychic, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596058|NCT02942017|2934355|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.186||0.4482|2-Sided|95.0|-0.51|0.23|||MMRM|||Anxiety Psychic, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596059|NCT02942017|2934355|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.184||0.4741|2-Sided|95.0|-0.5|0.23|||MMRM|||Anxiety Psychic, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596060|NCT02942017|2934355|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.189||0.5212|2-Sided|95.0|-0.5|0.25|||MMRM|||Anxiety Psychic, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596061|NCT02942017|2934355|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.185||0.393|2-Sided|95.0|-0.53|0.21|||MMRM|||Anxiety Psychic, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596062|NCT02942017|2934355|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.18||0.5182|2-Sided|95.0|-0.47|0.24|||MMRM|||Anxiety Psychic, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596063|NCT02942017|2934355|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.162||0.1767|2-Sided|95.0|-0.54|0.1|||MMRM|||Anxiety Psychic, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596064|NCT02942017|2934355|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.1||0.1905|2-Sided|95.0|-0.33|0.07|||MMRM|||Agitation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596065|NCT02942017|2934355|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.155||0.5839|2-Sided|95.0|-0.39|0.22|||MMRM|||Agitation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596066|NCT02942017|2934355|Superiority||LS Mean Difference|-0.1|Standard Error of the Mean|0.147||0.5111|2-Sided|95.0|-0.39|0.2|||MMRM|||Agitation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596067|NCT02942017|2934355|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.131||0.0498|2-Sided|95.0|-0.52|0.0|||MMRM|||Agitation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596068|NCT02942017|2934355|Superiority||LS Mean Difference|-0.38|Standard Error of the Mean|0.126||0.0036|2-Sided|95.0|-0.63|-0.13|||MMRM|||Agitation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596069|NCT02942017|2934355|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.133||0.0973|2-Sided|95.0|-0.48|0.04|||MMRM|||Agitation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596070|NCT02942017|2934355|Superiority||LS Mean Difference|-0.34|Standard Error of the Mean|0.118||0.0051|2-Sided|95.0|-0.57|-0.1|||MMRM|||Agitation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596071|NCT02942017|2934355|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.126||0.0433|2-Sided|95.0|-0.51|-0.01|||MMRM|||Agitation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596072|NCT02942017|2934355|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.109||0.0422|2-Sided|95.0|-0.44|-0.01|||MMRM|||Agitation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596073|NCT02942017|2934355|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.127||0.0215|2-Sided|95.0|-0.55|-0.04|||MMRM|||Agitation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596074|NCT02942017|2934355|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.108||0.006|2-Sided|95.0|-0.52|-0.09|||MMRM|||Agitation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596075|NCT02942017|2934355|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.11||0.0431|2-Sided|95.0|-0.44|-0.01|||MMRM|||Agitation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596076|NCT02942017|2934355|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.103||0.0573|2-Sided|95.0|-0.4|0.01|||MMRM|||Agitation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596077|NCT02942017|2934355|Superiority||LS Mean Difference|-0.02|Standard Error of the Mean|0.075||0.7992|2-Sided|95.0|-0.17|0.13|||MMRM|||Retardation, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects|
1620540|NCT02314923|2977569|Other||||||<|0.427|||||||ANOVA||||
1596078|NCT02942017|2934355|Superiority||LS Mean Difference|-0.06|Standard Error of the Mean|0.092||0.5489|2-Sided|95.0|-0.24|0.13|||MMRM|||Retardation, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects|
1596079|NCT02942017|2934355|Superiority||LS Mean Difference|-0.1|Standard Error of the Mean|0.079||0.1976|2-Sided|95.0|-0.26|0.06|||MMRM|||Retardation, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects|
1596080|NCT02942017|2934355|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.099||0.0311|2-Sided|95.0|-0.41|-0.02|||MMRM|||Retardation, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects|
1596081|NCT02942017|2934355|Superiority||LS Mean Difference|0.04|Standard Error of the Mean|0.1||0.7003|2-Sided|95.0|-0.16|0.24|||MMRM|||Retardation, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects|
1596082|NCT02942017|2934355|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.089||0.3385|2-Sided|95.0|-0.26|0.09|||MMRM|||Retardation, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects|
1596083|NCT02942017|2934355|Superiority||LS Mean Difference|0.11|Standard Error of the Mean|0.109||0.3223|2-Sided|95.0|-0.11|0.32|||MMRM|||Retardation, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects|
1596084|NCT02942017|2934355|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|0.114||0.8001|2-Sided|95.0|-0.25|0.2|||MMRM|||Retardation, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596085|NCT02942017|2934355|Superiority||LS Mean Difference|0.0|Standard Error of the Mean|0.125||0.9702|2-Sided|95.0|-0.24|0.25|||MMRM|||Retardation, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596086|NCT02942017|2934355|Superiority||LS Mean Difference|-0.02|Standard Error of the Mean|0.112||0.856|2-Sided|95.0|-0.24|0.2|||MMRM|||Retardation, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596087|NCT02942017|2934355|Superiority||LS Mean Difference|0.12|Standard Error of the Mean|0.117||0.3088|2-Sided|95.0|-0.11|0.35|||MMRM|||Retardation, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596088|NCT02942017|2934355|Superiority||LS Mean Difference|0.2|Standard Error of the Mean|0.117||0.0891|2-Sided|95.0|-0.03|0.43|||MMRM|||Retardation, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596089|NCT02942017|2934355|Superiority||LS Mean Difference|0.09|Standard Error of the Mean|0.121||0.4602|2-Sided|95.0|-0.15|0.33|||MMRM|||Retardation, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596090|NCT02942017|2934355|Superiority||LS Mean Difference|0.04|Standard Error of the Mean|0.191||0.844|2-Sided|95.0|-0.34|0.42|||MMRM|||Work and Activities, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1620541|NCT02314923|2977569|Other||||||<|0.001|||||||ANOVA||||
1596091|NCT02942017|2934355|Superiority||LS Mean Difference|0.05|Standard Error of the Mean|0.239||0.833|2-Sided|95.0|-0.42|0.53|||MMRM|||Work and Activities, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596092|NCT02942017|2934355|Superiority||LS Mean Difference|-0.43|Standard Error of the Mean|0.22||0.0518|2-Sided|95.0|-0.87|0.0|||MMRM|||Work and Activities, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596093|NCT02942017|2934355|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.212||0.1865|2-Sided|95.0|-0.7|0.14|||MMRM|||Work and Activities, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596094|NCT02942017|2934355|Superiority||LS Mean Difference|-0.38|Standard Error of the Mean|0.192||0.0504|2-Sided|95.0|-0.76|0.0|||MMRM|||Work and Activities, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596095|NCT02942017|2934355|Superiority||LS Mean Difference|-0.44|Standard Error of the Mean|0.177||0.0155|2-Sided|5.0|-0.79|-0.09|||Wilcoxon (Mann-Whitney)|||Work and Activities, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596096|NCT02942017|2934355|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.184||0.1568|2-Sided|95.0|-0.63|0.1|||MMRM|||Work and Activities, Hour 48 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596097|NCT02942017|2934355|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.196||0.5836|2-Sided|95.0|-0.5|0.28|||MMRM|||Work and Activities, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596098|NCT02942017|2934355|Superiority||LS Mean Difference|0.01|Standard Error of the Mean|0.2||0.9636|2-Sided|95.0|-0.39|0.41|||MMRM|||Work and Activities, Hour 24 : MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596099|NCT02942017|2934355|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.203||0.595|2-Sided|95.0|-0.51|0.29|||MMRM|||Work and Activities, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596100|NCT02942017|2934355|Superiority||LS Mean Difference|-0.25|Standard Error of the Mean|0.185||0.188|2-Sided|95.0|-0.61|0.12|||MMRM|||Work and Activities, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596101|NCT02942017|2934355|Superiority||LS Mean Difference|0.01|Standard Error of the Mean|0.17||0.9475|2-Sided|95.0|-0.33|0.35|||MMRM|||Work and Activities, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596102|NCT02942017|2934355|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.137||0.2865|2-Sided|95.0|-0.42|0.13|||MMRM|||Work and Activities, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596753|NCT02940886|2934400|Non-Inferiority|Non-inferiority can be claimed if the upper bound of the 95% CI is below 1.5 % point.|Risk Difference (RD)|0.1|||||2-Sided|95.0|-0.57|0.48||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the pooled FERWON-IDA and FERWON-NEPHRO trials (2008 subjects treated with iron isomaltoside/ferric derisomaltose and 1000 subjects treated with iron sucrose) with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.|
1596103|NCT02942017|2934355|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.134||0.7057|2-Sided|95.0|-0.32|0.22|||MMRM|||Insomnia-Late, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596104|NCT02942017|2934355|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.171||0.444|2-Sided|95.0|-0.47|0.21|||MMRM|||Insomnia-Late, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596105|NCT02942017|2934355|Superiority||LS Mean Difference|-0.38|Standard Error of the Mean|0.176||0.0326|2-Sided|95.0|-0.73|-0.03|||MMRM|||Insomnia-Late, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596106|NCT02942017|2934355|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.135||0.1923|2-Sided|95.0|-0.45|0.09|||MMRM|||Insomnia-Late, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596107|NCT02942017|2934355|Superiority||LS Mean Difference|-0.25|Standard Error of the Mean|0.141||0.0749|2-Sided|95.0|-0.54|0.03|||MMRM|||Insomnia-Late, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596108|NCT02942017|2934355|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|0.132||0.8262|2-Sided|95.0|-0.29|0.23|||MMRM|||Insomnia-Late, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596109|NCT02942017|2934355|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.131||0.6931|2-Sided|95.0|-0.31|0.21|||MMRM|||Insomnia-Late, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596110|NCT02942017|2934355|Superiority||LS Mean Difference|0.01|Standard Error of the Mean|0.139||0.9272|2-Sided|95.0|-0.26|0.29|||MMRM|||Insomnia-Late, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596111|NCT02942017|2934355|Superiority||LS Mean Difference|0.134|Standard Error of the Mean|0.134||0.6869|2-Sided|95.0|-0.32|0.21|||MMRM|||Insomnia-Late, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596112|NCT02942017|2934355|Superiority||LS Mean Difference|-0.01|Standard Error of the Mean|0.121||0.9038|2-Sided|95.0|-0.25|0.23|||MMRM|||Insomnia-Late, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596113|NCT02942017|2934355|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|0.119||0.7848|2-Sided|95.0|-0.27|0.2|||MMRM|||Insomnia-Late, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596114|NCT02942017|2934355|Superiority||LS Mean Difference|0.07|Standard Error of the Mean|0.127||0.6073|2-Sided|95.0|-0.19|0.32|||MMRM|||Insomnia-Late, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596115|NCT02942017|2934355|Superiority||LS Mean Difference|0.11|Standard Error of the Mean|0.121||0.3805|2-Sided|95.0|-0.13|0.35|||MMRM|||Insomnia-Late, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1620542|NCT02314923|2977569|Other||||||<|0.003|||||||ANOVA||||
1596116|NCT02942017|2934355|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.165||0.6763|2-Sided|95.0|-0.4|0.26|||MMRM|||Insomnia-Middle, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596117|NCT02942017|2934355|Superiority||LS Mean Difference|0.02|Standard Error of the Mean|0.189||0.9175|2-Sided|95.0|-0.36|0.39|||MMRM|||Insomnia-Middle, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596118|NCT02942017|2934355|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.185||0.2213|2-Sided|95.0|-0.6|0.14|||MMRM|||Insomnia-Middle, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596119|NCT02942017|2934355|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.152||0.1631|2-Sided|95.0|-0.52|0.09|||MMRM|||Insomnia-Middle, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596120|NCT02942017|2934355|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.135||0.0925|2-Sided|95.0|-0.5|0.04|||MMRM|||Insomnia-Middle, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596121|NCT02942017|2934355|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.132||0.0295|2-Sided|95.0|-0.56|-0.03|||MMRM|||Insomnia-Middle, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596122|NCT02942017|2934355|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.144||0.0406|2-Sided|95.0|-0.58|-0.01|||MMRM|||Insomnia-Middle, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596123|NCT02942017|2934355|Superiority||LS Mean Difference|-0.27|Standard Error of the Mean|0.139||0.054|2-Sided|95.0|-0.55|0.0|||MMRM|||Insomnia-Middle, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596124|NCT02942017|2934355|Superiority||LS Mean Difference|-0.32|Standard Error of the Mean|0.139||0.0234|2-Sided|95.0|-0.59|-0.04|||MMRM|||Insomnia-Middle, Hour 24 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596125|NCT02942017|2934355|Superiority||LS Mean Difference|0.15|Standard Error of the Mean|0.124||0.2433|2-Sided|95.0|-0.1|0.39|||MMRM|||Insomnia-Middle, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596126|NCT02942017|2934355|Superiority||LS Mean Difference|0.06|Standard Error of the Mean|0.121||0.6173|2-Sided|95.0|-0.18|0.3|||MMRM|||Insomnia-Middle, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596127|NCT02942017|2934355|Superiority||LS Mean Difference|-0.01|Standard Error of the Mean|0.121||0.9029|2-Sided|95.0|-0.26|0.23|||MMRM|||Insomnia-Middle, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596128|NCT02942017|2934355|Superiority||LS Mean Difference|0.1|Standard Error of the Mean|0.117||0.3776|2-Sided|95.0|-0.13|0.34|||MMRM|||Insomnia-Middle, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596129|NCT02942017|2934355|Superiority||LS Mean Difference|0.1|Standard Error of the Mean|0.174||0.5862|2-Sided|95.0|-0.25|0.44|||MMRM|||Insomnia-Early, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596130|NCT02942017|2934355|Superiority||LS Mean Difference|0.03|Standard Error of the Mean|0.216||0.8969|2-Sided|95.0|-0.4|0.46|||MMRM|||Insomnia-Early, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596131|NCT02942017|2934355|Superiority||LS Mean Difference|-0.19|Standard Error of the Mean|0.197||0.3341|2-Sided|95.0|-0.58|0.2|||MMRM|||Insomnia-Early, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596132|NCT02942017|2934355|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.18||0.1531|2-Sided|95.0|-0.62|0.1|||MMRM|||Insomnia-Early, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596133|NCT02942017|2934355|Superiority||LS Mean Difference|-0.39|Standard Error of the Mean|0.163||0.0187|2-Sided|95.0|-0.72|-0.07|||MMRM|||Insomnia-Early, Hour 72 MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596134|NCT02942017|2934355|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.18||0.6187|2-Sided|95.0|-0.45|0.27|||MMRM|||Insomnia-Early, Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596135|NCT02942017|2934355|Superiority||LS Mean Difference|-0.32|Standard Error of the Mean|0.168||0.056|2-Sided|95.0|-0.66|0.01|||MMRM|||Insomnia-Early, Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596136|NCT02942017|2934355|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.157||0.2595|2-Sided|95.0|-0.49|0.13|||MMRM|||Insomnia-Early, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596137|NCT02942017|2934355|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.151||0.0839|2-Sided|95.0|-0.56|0.04|||MMRM|||Insomnia-Early, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596138|NCT02942017|2934355|Superiority||LS Mean Difference|0.11|Standard Error of the Mean|0.118||0.3498|2-Sided|95.0|-0.12|0.35|||MMRM|||Insomnia-Early, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596139|NCT02942017|2934355|Superiority||LS Mean Difference|0.02|Standard Error of the Mean|0.11||0.8743|2-Sided|95.0|-0.2|0.24|||MMRM|||Insomnia-Early, Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596140|NCT02942017|2934355|Superiority||LS Mean Difference|0.09|Standard Error of the Mean|0.121||0.4426|2-Sided|95.0|-0.15|0.33|||MMRM|||Insomnia-Early, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596141|NCT02942017|2934355|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.097||0.6996|2-Sided|95.0|-0.23|0.16|||MMRM|||Insomnia-Early, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596142|NCT02942017|2934355|Superiority||LS Mean Difference|-0.01|Standard Error of the Mean|0.083||0.8884|2-Sided|95.0|-0.17|0.15|||MMRM|||Suicide, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596143|NCT02942017|2934355|Superiority||LS Mean Difference|0.0|Standard Error of the Mean|0.091||0.9838|2-Sided|95.0|-0.18|0.18|||MMRM|||Suicide, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596144|NCT02942017|2934355|Superiority||LS Mean Difference|0.04|Standard Error of the Mean|0.091||0.6714|2-Sided|95.0|-0.14|0.22|||MMRM|||Suicide, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596145|NCT02942017|2934355|Superiority||LS Mean Difference|-0.01|Standard Error of the Mean|0.082||0.9255|2-Sided|95.0|-0.17|0.15|||MMRM|||Suicide, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596146|NCT02942017|2934355|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.082||0.3822|2-Sided|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596147|NCT02942017|2934355|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.082||0.3854|2-Sided|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596148|NCT02942017|2934355|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.082||0.1811|2-Sided|95.0|-0.27|0.05|||MMRM|||Suicide, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596149|NCT02942017|2934355|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.082||0.275|2-Sided|95.0|-0.25|0.07|||MMRM|||Suicide, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596150|NCT02942017|2934355|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.082||0.3884|2-Sided|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596151|NCT02942017|2934355|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.082||0.2819|2-Sided|95.0|-0.25|0.07|||MMRM|||Suicide, Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596152|NCT02942017|2934355|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.082||0.4127|2-Sided|95.0|-0.23|0.09|||MMRM|||Suicide, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596153|NCT02942017|2934355|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.082||0.3023|2-Sided|95.0|-0.24|0.08|||MMRM|||Suicide, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596154|NCT02942017|2934355|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.082||0.324|2-Sided|95.0|-0.24|0.08|||MMRM|||Suicide, Hour 2:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1598436|NCT02900378|2936703|Other|||||||0.0082|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4|
1596155|NCT02942017|2934355|Superiority||LS Mean Difference|0.11|Standard Error of the Mean|0.145||0.4613|2-Sided|95.0|-0.18|0.4|||MMRM|||Feeling of Guilt, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596156|NCT02942017|2934355|Superiority||LS Mean Difference|-0.1|Standard Error of the Mean|0.168||0.5674|2-Sided|95.0|-0.43|0.24|||MMRM|||Feeling of Guilt, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596157|NCT02942017|2934355|Superiority||LS Mean Difference|-0.1|Standard Error of the Mean|0.179||0.5828|2-Sided|95.0|-0.46|0.26|||MMRM|||Feeling of Guilt, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596158|NCT02942017|2934355|Superiority||LS Mean Difference|-0.32|Standard Error of the Mean|0.182||0.0837|2-Sided|95.0|-0.68|0.04|||MMRM|||Feeling of Guilt, Day 7:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596159|NCT02942017|2934355|Superiority||LS Mean Difference|-0.4|Standard Error of the Mean|0.16||0.0147|2-Sided|95.0|-0.72|-0.08|||MMRM|||Feeling of Guilt, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596160|NCT02942017|2934355|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.156||0.0682|2-Sided|95.0|-0.6|0.02|||MMRM|||Feeling of Guilt, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596161|NCT02942017|2934355|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.173||0.2222|2-Sided|95.0|-0.56|0.13|||MMRM|||Feeling of Guilt, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596162|NCT02942017|2934355|Superiority||LS Mean Difference|-0.34|Standard Error of the Mean|0.169||0.0468|2-Sided|95.0|-0.68|0.0|||MMRM|||Feeling of Guilt, Hour 36:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596163|NCT02942017|2934355|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.162||0.0717|2-Sided|95.0|-0.62|0.03|||MMRM|||Feeling of Guilt, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596164|NCT02942017|2934355|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.168||0.0901|2-Sided|95.0|-0.62|0.05|||MMRM|||Feeling of Guilt, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596165|NCT02942017|2934355|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.163||0.1546|2-Sided|95.0|-0.56|0.09|||MMRM|||Feeling of Guilt, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596166|NCT02942017|2934355|Superiority||LS Mean Difference|-0.44|Standard Error of the Mean|0.168||0.0101|2-Sided|95.0|-0.77|-0.11|||MMRM|||Feeling of Guilt, Hour 4:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596167|NCT02942017|2934355|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.165||0.1925|2-Sided|95.0|-0.55|0.11|||MMRM|||Feeling of Guilt, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596168|NCT02942017|2934355|Superiority||LS Mean Difference|0.19|Standard Error of the Mean|0.182||0.3096|2-Sided|95.0|-0.18|0.55|||MMRM|||Depressed Mood, Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596169|NCT02942017|2934355|Superiority||LS Mean Difference|0.24|Standard Error of the Mean|0.228||0.2905|2-Sided|95.0|-0.21|0.7|||MMRM|||Depressed Mood, Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596170|NCT02942017|2934355|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.232||0.4458|2-Sided|95.0|-0.64|0.28|||MMRM|||Depressed Mood, Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596171|NCT02942017|2934355|Superiority||LS Mean Difference|-0.4|Standard Error of the Mean|0.215||0.0683|2-Sided|95.0|-0.82|0.03|||MMRM|||Depressed Mood, Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596172|NCT02942017|2934355|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.182||0.1059|2-Sided|95.0|-0.66|0.06|||MMRM|||Depressed Mood, Hour 72:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596173|NCT02942017|2934355|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.189||0.1273|2-Sided|95.0|-0.67|0.08|||MMRM|||Depressed Mood, Hour 60:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596174|NCT02942017|2934355|Superiority||LS Mean Difference|-0.41|Standard Error of the Mean|0.192||0.0332|2-Sided|95.0|-0.79|-0.03|||MMRM|||Depressed Mood, Hour 48:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596175|NCT02942017|2934355|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.193||0.1325|2-Sided|95.0|-0.68|0.09|||MMRM|||Depressed Mood, Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596176|NCT02942017|2934355|Superiority||LS Mean Difference|-0.33|Standard Error of the Mean|0.191||0.0844|2-Sided|95.0|-0.71|0.05|||MMRM|||Depressed Mood, Hour 24:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596177|NCT02942017|2934355|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.183||0.4803|2-Sided|95.0|-0.49|0.23|||MMRM|||Depressed Mood, Hour 12:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596178|NCT02942017|2934355|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.178||0.0963|2-Sided|95.0|-0.65|0.05|||MMRM|||Depressed Mood, Hour 8:MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596179|NCT02942017|2934355|Superiority||LS Mean Difference|-0.25|Standard Error of the Mean|0.181||0.1672|2-Sided|95.0|-0.61|0.11|||MMRM|||Depressed Mood, Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596180|NCT02942017|2934355|Superiority||LS Mean Difference|-0.1|Standard Error of the Mean|0.154||0.5132|2-Sided|95.0|-0.41|0.21|||MMRM|||Depressed Mood, Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item score at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1620543|NCT02314923|2977569|Other||||||<|0.325|||||||ANOVA||||
1596181|NCT02942017|2934356|Superiority||LS mean difference|1.37|Standard Error of the Mean|3.149||0.6637|2-Sided|95.0|-4.88|7.63|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596182|NCT02942017|2934356|Superiority||LS mean difference|-9.75|Standard Error of the Mean|3.566||0.0074|2-Sided|95.0|-16.83|-2.68|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596183|NCT02942017|2934356|Superiority||LS mean difference|-8.35|Standard Error of the Mean|2.989||0.0063|2-Sided|95.0|-14.29|-2.42|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit was the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596184|NCT02942017|2934357|Superiority||Odds Ratio (OR)|0.6||||0.3085|2-Sided|95.0|0.3|1.5|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.|
1596185|NCT02942017|2934357|Superiority||Odds Ratio (OR)|3.7||||0.0046|2-Sided|95.0|1.5|9.3|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.|
1596186|NCT02942017|2934357|Superiority||Odds Ratio (OR)|3.4||||0.0033|2-Sided|95.0|1.5|7.9||Hour 60:|GEE method|||Hour 60: GEE method was used for analysis. The HAM-D remission at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.|
1596187|NCT02942017|2934358|Superiority||Odds Ratio (OR)|0.8||||0.5857|2-Sided|95.0|0.3|2.0|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.|
1596188|NCT02942017|2934358|Superiority||Odds Ratio (OR)|2.6||||0.0482|2-Sided|95.0|1.0|6.6|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.|
1596189|NCT02942017|2934358|Superiority||Odds Ratio (OR)|2.9||||0.0168|2-Sided|95.0|1.2|6.7|||GEE method|||Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model.|
1596190|NCT02942017|2934359|Superiority||LS Mean Difference|-0.33|Standard Error of the Mean|1.4||0.817|2-Sided|95.0|-3.11|2.46|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596191|NCT02942017|2934359|Superiority||LS Mean Difference|-2.03|Standard Error of the Mean|1.356||0.1375|2-Sided|95.0|-4.73|0.66|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596192|NCT02942017|2934359|Superiority||LS Mean Difference|-3.24|Standard Error of the Mean|1.429||0.0255|2-Sided|95.0|-6.08|-0.4|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596193|NCT02942017|2934359|Superiority||LS Mean Difference|-3.48|Standard Error of the Mean|1.108||0.0022|2-Sided|95.0|-5.67|-1.28|||MMRM|||Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596194|NCT02942017|2934359|Superiority||LS Mean Difference|-2.42|Standard Error of the Mean|1.155||0.0389|2-Sided|95.0|-4.71|-0.13|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596754|NCT02940886|2934400|Other||Risk Difference (RD)|-0.1|||||2-Sided|95.0|-0.91|0.71||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the individual trial with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.|
1620544|NCT02314923|2977569|Other||||||<|0.029|||||||ANOVA||||
1596195|NCT02942017|2934359|Superiority||LS Mean Difference|-1.85|Standard Error of the Mean|1.113||0.0991|2-Sided|95.0|-4.06|0.36|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596196|NCT02942017|2934359|Superiority||LS Mean Difference|-1.61|Standard Error of the Mean|1.091||0.1431|2-Sided|95.0|-3.78|0.55|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596197|NCT02942017|2934359|Superiority||LS Mean Difference|-1.14|Standard Error of the Mean|0.994||0.2522|2-Sided|95.0|-3.12|0.83|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596198|NCT02942017|2934359|Superiority||LS Mean Difference|-0.95|Standard Error of the Mean|0.962||0.328|2-Sided|95.0|-2.86|0.96|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596199|NCT02942017|2934359|Superiority||LS Mean Difference|-0.77|Standard Error of the Mean|0.905||0.3947|2-Sided|95.0|-2.57|1.02|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596200|NCT02942017|2934359|Superiority||LS Mean Difference|-0.6|Standard Error of the Mean|0.738||0.4216|2-Sided|95.0|-2.06|0.87|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596201|NCT02942017|2934360|Superiority||LS Mean Difference|0.54|Standard Error of the Mean|1.271||0.671|2-Sided|95.0|-1.98|3.07|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596202|NCT02942017|2934361|Superiority||Least Square (LS) Mean Difference|-2.5|Standard Error of the Mean|1.019||0.016|2-Sided|95.0|-4.52|-0.48|||MMRM|||Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596203|NCT02942004|2934364|Superiority||LS mean difference|-1.46|Standard Error of the Mean|1.468||0.3236|2-Sided|95.0|-4.37|1.45|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596204|NCT02942004|2934364|Superiority||LS mean difference|-2.02|Standard Error of the Mean|1.488||0.1767|2-Sided|95.0|-4.97|0.93|||MMRM|||Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596205|NCT02942004|2934364|Superiority||LS mean difference|-0.76|Standard Error of the Mean|1.566||0.6307|2-Sided|95.0|-3.86|2.35|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596206|NCT02942004|2934364|Superiority||LS mean difference|-0.06|Standard Error of the Mean|1.608||0.9701|2-Sided|95.0|-3.25|3.13|||MMRM|||Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596207|NCT02942004|2934364|Superiority||LS mean difference|-0.11|Standard Error of the Mean|1.552||0.9434|2-Sided|95.0|-3.19|2.97|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1597014|NCT02926573|2935232|Superiority||Mean Difference (Final Values)|5.1|||||2-Sided|95.0|-6.6|16.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.||
1596208|NCT02942004|2934364|Superiority||LS mean difference|-0.6|Standard Error of the Mean|1.59||0.7063|2-Sided|95.0|-3.75|2.55|||MMRM|||Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596209|NCT02942004|2934364|Superiority||LS mean difference|0.25|Standard Error of the Mean|1.338||0.8495|2-Sided|95.0|-2.4|2.91|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596210|NCT02942004|2934364|Superiority||LS mean difference|-2.56|Standard Error of the Mean|1.356||0.0622|2-Sided|95.0|-5.24|0.13|||MMRM|||Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596211|NCT02942004|2934364|Superiority||LS mean difference|-1.05|Standard Error of the Mean|1.427||0.4645|2-Sided|95.0|-3.88|1.78|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596212|NCT02942004|2934364|Superiority||LS mean difference|-1.13|Standard Error of the Mean|1.454||0.4389|2-Sided|95.0|-4.01|1.75|||MMRM|||Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596213|NCT02942004|2934365|Superiority||Odds Ratio (OR)|2.6||||0.046|2-Sided|95.0|1.0|6.9|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.|
1596214|NCT02942004|2934365|Superiority||Odds Ratio (OR)|3.6||||0.0139|2-Sided|95.0|1.3|10.0|||GEE method|||Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.|
1596215|NCT02942004|2934365|Superiority||Odds Ratio (OR)|2.2||||0.0931|2-Sided|95.0|0.9|5.3|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.|
1596216|NCT02942004|2934365|Superiority||Odds Ratio (OR)|2.9||||0.0323|2-Sided|95.0|1.1|7.5|||GEE method|||Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.|
1596217|NCT02942004|2934365|Superiority||Odds Ratio (OR)|4.0||||0.0095|2-Sided|95.0|1.4|11.6|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.|
1596218|NCT02942004|2934365|Superiority||Odds Ratio (OR)|4.0||||0.0131|2-Sided|95.0|1.3|11.7|||GEE method|||Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.|
1596219|NCT02942004|2934366|Superiority||LS mean difference|-3.59|Standard Error of the Mean|2.726||0.1908|2-Sided|95.0|-8.99|1.81|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596220|NCT02942004|2934366|Superiority||LS mean difference|-5.64|Standard Error of the Mean|2.777||0.0447|2-Sided|95.0|-11.14|-0.14|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596221|NCT02942004|2934366|Superiority||LS mean difference|-1.31|Standard Error of the Mean|2.618||0.6167|2-Sided|95.0|-6.5|3.87|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596755|NCT02940886|2934400|Other||95% two-sided CI (iron isomaltoside)|0.3|||||2-Sided|95.0|0.06|0.88||||||"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose, the power was 88% to demonstrate that the upper bound of the 95% CI of the incidence of treatment-emergent serious and/or severe non-serious hypersensitivity AEs was less than 3%.~The significance level was set to 5%."|
1598437|NCT02900378|2936703|Other|||||||0.4137|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3|
1596222|NCT02942004|2934366|Superiority||LS mean difference|-4.3|Standard Error of the Mean|2.673||0.1101|2-Sided|95.0|-9.6|0.99|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596223|NCT02942004|2934366|Superiority||LS mean difference|-4.2|Standard Error of the Mean|2.35||0.0763|2-Sided|95.0|-8.86|0.45|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596224|NCT02942004|2934366|Superiority||LS mean difference|-6.85|Standard Error of the Mean|2.414||0.0054|2-Sided|95.0|-11.64|-2.07|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596225|NCT02942004|2934367|Superiority||LS mean difference|-0.08|Standard Error of the Mean|0.054||0.1603|2-Sided|95.0|-0.18|0.03|||MMRM|||Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596226|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.055||0.2825|2-Sided|95.0|-0.17|0.05|||MMRM|||Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596227|NCT02942004|2934367|Superiority||LS mean difference|0.01|Standard Error of the Mean|0.059||0.8163|2-Sided|95.0|-0.1|0.13|||MMRM|||Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596228|NCT02942004|2934367|Superiority||LS mean difference|0.02|Standard Error of the Mean|0.062||0.7136|2-Sided|95.0|-0.1|0.14|||MMRM|||Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596229|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.059||0.3492|2-Sided|95.0|-0.17|0.06|||MMRM|||Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596230|NCT02942004|2934367|Superiority||LS mean difference|-0.04|Standard Error of the Mean|0.061||0.4967|2-Sided|95.0|-0.16|0.08|||MMRM|||Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596231|NCT02942004|2934367|Superiority||LS mean difference|0.02|Standard Error of the Mean|0.053||0.6379|2-Sided|95.0|-0.08|0.13|||MMRM|||Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596232|NCT02942004|2934367|Superiority||LS mean difference|-0.01|Standard Error of the Mean|0.054||0.9188|2-Sided|95.0|-0.11|0.1|||MMRM|||Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596233|NCT02942004|2934367|Superiority||LS mean difference|0.0|Standard Error of the Mean|0.053||0.9752|2-Sided|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596234|NCT02942004|2934367|Superiority||LS mean difference|0.05|Standard Error of the Mean|0.054||0.3755|2-Sided|95.0|-0.06|0.16|||MMRM|||Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1598438|NCT02900378|2936703|Other|||||||0.0528|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2|
1596235|NCT02942004|2934367|Superiority||LS mean difference|-0.03|Standard Error of the Mean|0.053||0.5948|2-Sided|95.0|-0.13|0.08|||MMRM|||Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596236|NCT02942004|2934367|Superiority||LS mean difference|-0.01|Standard Error of the Mean|0.054||0.916|2-Sided|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596237|NCT02942004|2934367|Superiority||LS mean difference|0.05|Standard Error of the Mean|0.053||0.3472|2-Sided|95.0|-0.05|0.15|||MMRM|||Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596238|NCT02942004|2934367|Superiority||LS mean difference|0.05|Standard Error of the Mean|0.054||0.34|2-Sided|95.0|-0.05|0.16|||MMRM|||Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596239|NCT02942004|2934367|Superiority||LS mean difference|0.02|Standard Error of the Mean|0.053||0.6397|2-Sided|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596240|NCT02942004|2934367|Superiority||LS mean difference|0.0|Standard Error of the Mean|0.055||0.9676|2-Sided|95.0|-0.11|0.11|||MMRM|||Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596241|NCT02942004|2934367|Superiority||LS mean difference|0.0|Standard Error of the Mean|0.053||0.9602|2-Sided|95.0|-0.1|0.11|||MMRM|||Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596242|NCT02942004|2934367|Superiority||LS mean difference|-0.05|Standard Error of the Mean|0.054||0.3916|2-Sided|95.0|-0.15|0.06|||MMRM|||Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596243|NCT02942004|2934367|Superiority||LS mean difference|0.1|Standard Error of the Mean|0.053||0.0599|2-Sided|95.0|0.0|0.2|||MMRM|||Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596244|NCT02942004|2934367|Superiority||LS mean difference|-0.03|Standard Error of the Mean|0.054||0.5763|2-Sided|95.0|-0.14|0.08|||MMRM|||Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596245|NCT02942004|2934367|Superiority||LS mean difference|0.07|Standard Error of the Mean|0.053||0.161|2-Sided|95.0|-0.03|0.18|||MMRM|||Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596246|NCT02942004|2934367|Superiority||LS mean difference|0.0|Standard Error of the Mean|0.054||0.9638|2-Sided|95.0|-0.11|0.1|||MMRM|||Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596247|NCT02942004|2934367|Superiority||LS mean difference|0.05|Standard Error of the Mean|0.053||0.336|2-Sided|95.0|-0.05|0.15|||MMRM|||Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1598439|NCT02900378|2936703|Other|||||||0.0854|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1|
1596248|NCT02942004|2934367|Superiority||LS mean difference|0.0|Standard Error of the Mean|0.054||0.9911|2-Sided|95.0|-0.11|0.11|||MMRM|||Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596249|NCT02942004|2934367|Superiority||LS mean difference|0.03|Standard Error of the Mean|0.053||0.6169|2-Sided|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596250|NCT02942004|2934367|Superiority||LS mean difference|0.03|Standard Error of the Mean|0.054||0.6191|2-Sided|95.0|-0.08|0.13|||MMRM|||Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596251|NCT02942004|2934367|Superiority||LS mean difference|-0.24|Standard Error of the Mean|0.194||0.2185|2-Sided|95.0|-0.62|0.14|||MMRM|||Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596252|NCT02942004|2934367|Superiority||LS mean difference|-0.31|Standard Error of the Mean|0.195||0.1141|2-Sided|95.0|-0.7|0.08|||MMRM|||Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596253|NCT02942004|2934367|Superiority||LS mean difference|-0.12|Standard Error of the Mean|0.231||0.6136|2-Sided|95.0|-0.58|0.34|||MMRM|||Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596254|NCT02942004|2934367|Superiority||LS mean difference|-0.1|Standard Error of the Mean|0.238||0.6736|2-Sided|95.0|-0.57|0.37|||MMRM|||Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596255|NCT02942004|2934367|Superiority||LS mean difference|-0.21|Standard Error of the Mean|0.217||0.3239|2-Sided|95.0|-0.65|0.22|||MMRM|||Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596256|NCT02942004|2934367|Superiority||LS mean difference|0.01|Standard Error of the Mean|0.222||0.9776|2-Sided|95.0|-0.43|0.45|||MMRM|||Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596257|NCT02942004|2934367|Superiority||LS mean difference|-0.3|Standard Error of the Mean|0.185||0.1106|2-Sided|95.0|-0.66|0.07|||MMRM|||Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596258|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.187||0.7604|2-Sided|95.0|-0.43|0.31|||MMRM|||Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596259|NCT02942004|2934367|Superiority||LS mean difference|-0.12|Standard Error of the Mean|0.128||0.3589|2-Sided|95.0|-0.37|0.14|||MMRM|||Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596260|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.131||0.6274|2-Sided|95.0|-0.32|0.2|||MMRM|||Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596261|NCT02942004|2934367|Superiority||LS mean difference|-0.25|Standard Error of the Mean|0.134||0.0631|2-Sided|95.0|-0.52|0.01|||MMRM|||Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596262|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.138||0.2346|2-Sided|95.0|-0.44|0.11|||MMRM|||Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596263|NCT02942004|2934367|Superiority||LS mean difference|-0.21|Standard Error of the Mean|0.117||0.0782|2-Sided|95.0|-0.44|0.02|||MMRM|||Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596264|NCT02942004|2934367|Superiority||LS mean difference|-0.08|Standard Error of the Mean|0.12||0.5238|2-Sided|95.0|-0.31|0.16|||MMRM|||Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596265|NCT02942004|2934367|Superiority||LS mean difference|-0.05|Standard Error of the Mean|0.107||0.6333|2-Sided|95.0|-0.26|0.16|||MMRM|||Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596266|NCT02942004|2934367|Superiority||LS mean difference|0.04|Standard Error of the Mean|0.11||0.7093|2-Sided|95.0|-0.18|0.26|||MMRM|||Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596267|NCT02942004|2934367|Superiority||LS mean difference|-0.17|Standard Error of the Mean|0.118||0.1647|2-Sided|95.0|-0.4|0.07|||MMRM|||Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596268|NCT02942004|2934367|Superiority||LS mean difference|-0.05|Standard Error of the Mean|0.121||0.6527|2-Sided|95.0|-0.29|0.19|||MMRM|||Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596269|NCT02942004|2934367|Superiority||LS mean difference|0.0|Standard Error of the Mean|0.096||0.9671|2-Sided|95.0|-0.19|0.19|||MMRM|||Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596270|NCT02942004|2934367|Superiority||LS mean difference|0.12|Standard Error of the Mean|0.098||0.2246|2-Sided|95.0|-0.07|0.31|||MMRM|||Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596271|NCT02942004|2934367|Superiority||LS mean difference|0.03|Standard Error of the Mean|0.083||0.7215|2-Sided|95.0|-0.14|0.19|||MMRM|||Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596272|NCT02942004|2934367|Superiority||LS mean difference|0.05|Standard Error of the Mean|0.086||0.5421|2-Sided|95.0|-0.12|0.22|||MMRM|||Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596273|NCT02942004|2934367|Superiority||LS mean difference|0.08|Standard Error of the Mean|0.071||0.2715|2-Sided|95.0|-0.06|0.22|||MMRM|||Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596274|NCT02942004|2934367|Superiority||LS mean difference|0.03|Standard Error of the Mean|0.073||0.7229|2-Sided|95.0|-0.12|0.17|||MMRM|||Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596275|NCT02942004|2934367|Superiority||LS mean difference|0.1|Standard Error of the Mean|0.079||0.1901|2-Sided|95.0|-0.05|0.26|||MMRM|||Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596276|NCT02942004|2934367|Superiority||LS mean difference|0.08|Standard Error of the Mean|0.081||0.3158|2-Sided|95.0|-0.08|0.24|||MMRM|||Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596277|NCT02942004|2934367|Superiority||LS mean difference|0.0|Standard Error of the Mean|0.141||0.9749|2-Sided|95.0|-0.28|0.28|||MMRM|||Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596278|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.144||0.6978|2-Sided|95.0|-0.34|0.23|||MMRM|||Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596279|NCT02942004|2934367|Superiority||LS mean difference|0.27|Standard Error of the Mean|0.152||0.0811|2-Sided|95.0|-0.03|0.57|||MMRM|||Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596280|NCT02942004|2934367|Superiority||LS mean difference|0.04|Standard Error of the Mean|0.158||0.7994|2-Sided|95.0|-0.27|0.35|||MMRM|||Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596281|NCT02942004|2934367|Superiority||LS mean difference|0.03|Standard Error of the Mean|0.171||0.8644|2-Sided|95.0|-0.31|0.37|||MMRM|||Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596282|NCT02942004|2934367|Superiority||LS mean difference|-0.05|Standard Error of the Mean|0.177||0.7792|2-Sided|95.0|-0.4|0.3|||MMRM|||Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596283|NCT02942004|2934367|Superiority||LS mean difference|-0.09|Standard Error of the Mean|0.133||0.48|2-Sided|95.0|-0.36|0.17|||MMRM|||Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596284|NCT02942004|2934367|Superiority||LS mean difference|-0.2|Standard Error of the Mean|0.136||0.1486|2-Sided|95.0|-0.47|0.07|||MMRM|||Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596285|NCT02942004|2934367|Superiority||LS mean difference|0.05|Standard Error of the Mean|0.137||0.726|2-Sided|95.0|-0.22|0.32|||MMRM|||Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596286|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.141||0.6926|2-Sided|95.0|-0.34|0.22|||MMRM|||Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596287|NCT02942004|2934367|Superiority||LS mean difference|-0.1|Standard Error of the Mean|0.14||0.4649|2-Sided|95.0|-0.38|0.17|||MMRM|||Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596288|NCT02942004|2934367|Superiority||LS mean difference|-0.12|Standard Error of the Mean|0.144||0.4073|2-Sided|95.0|-0.4|0.17|||MMRM|||Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596289|NCT02942004|2934367|Superiority||LS mean difference|-0.1|Standard Error of the Mean|0.147||0.5139|2-Sided|95.0|-0.39|0.19|||MMRM|||Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596290|NCT02942004|2934367|Superiority||LS mean difference|-0.15|Standard Error of the Mean|0.151||0.3301|2-Sided|95.0|-0.45|0.15|||MMRM|||Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596291|NCT02942004|2934367|Superiority||LS mean difference|-0.1|Standard Error of the Mean|0.146||0.5107|2-Sided|95.0|-0.38|0.19|||MMRM|||Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596292|NCT02942004|2934367|Superiority||LS mean difference|-0.22|Standard Error of the Mean|0.15||0.151|2-Sided|95.0|-0.52|0.08|||MMRM|||Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596293|NCT02942004|2934367|Superiority||LS mean difference|-0.09|Standard Error of the Mean|0.146||0.5369|2-Sided|95.0|-0.38|0.2|||MMRM|||Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596294|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.151||0.2858|2-Sided|95.0|-0.46|0.14|||MMRM|||Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596295|NCT02942004|2934367|Superiority||LS mean difference|-0.11|Standard Error of the Mean|0.153||0.4622|2-Sided|95.0|-0.42|0.19|||MMRM|||Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596296|NCT02942004|2934367|Superiority||LS mean difference|-0.09|Standard Error of the Mean|0.158||0.5626|2-Sided|95.0|-0.4|0.22|||MMRM|||Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596297|NCT02942004|2934367|Superiority||LS mean difference|-0.18|Standard Error of the Mean|0.159||0.2601|2-Sided|95.0|-0.5|0.14|||MMRM|||Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596298|NCT02942004|2934367|Superiority||LS mean difference|-0.24|Standard Error of the Mean|0.164||0.1395|2-Sided|95.0|-0.57|0.08|||MMRM|||Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596299|NCT02942004|2934367|Superiority||LS mean difference|-0.01|Standard Error of the Mean|0.156||0.9272|2-Sided|95.0|-0.32|0.29|||MMRM|||Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596300|NCT02942004|2934367|Superiority||LS mean difference|-0.07|Standard Error of the Mean|0.16||0.6556|2-Sided|95.0|-0.39|0.25|||MMRM|||Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596301|NCT02942004|2934367|Superiority||LS mean difference|-0.11|Standard Error of the Mean|0.147||0.467|2-Sided|95.0|-0.4|0.18|||MMRM|||Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596302|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.151||0.6949|2-Sided|95.0|-0.36|0.24|||MMRM|||Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596303|NCT02942004|2934367|Superiority||LS mean difference|-0.13|Standard Error of the Mean|0.191||0.4907|2-Sided|95.0|-0.51|0.25|||MMRM|||Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596304|NCT02942004|2934367|Superiority||LS mean difference|-0.15|Standard Error of the Mean|0.193||0.4514|2-Sided|95.0|-0.53|0.24|||MMRM|||Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596305|NCT02942004|2934367|Superiority||LS mean difference|-0.19|Standard Error of the Mean|0.202||0.3533|2-Sided|95.0|-0.59|0.21|||MMRM|||Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596306|NCT02942004|2934367|Superiority||LS mean difference|-0.22|Standard Error of the Mean|0.212||0.3055|2-Sided|95.0|-0.64|0.2|||MMRM|||Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596307|NCT02942004|2934367|Superiority||LS mean difference|-0.34|Standard Error of the Mean|0.189||0.0718|2-Sided|95.0|-0.72|0.03|||MMRM|||Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596308|NCT02942004|2934367|Superiority||LS mean difference|-0.22|Standard Error of the Mean|0.194||0.2642|2-Sided|95.0|-0.6|0.17|||MMRM|||Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596309|NCT02942004|2934367|Superiority||LS mean difference|-0.28|Standard Error of the Mean|0.161||0.082|2-Sided|95.0|-0.6|0.04|||MMRM|||Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596310|NCT02942004|2934367|Superiority||LS mean difference|-0.2|Standard Error of the Mean|0.164||0.2174|2-Sided|95.0|-0.53|0.12|||MMRM|||Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596311|NCT02942004|2934367|Superiority||LS mean difference|-0.4|Standard Error of the Mean|0.152||0.0099|2-Sided|95.0|-0.7|-0.1|||MMRM|||Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596312|NCT02942004|2934367|Superiority||LS mean difference|-0.24|Standard Error of the Mean|0.156||0.1228|2-Sided|95.0|-0.55|0.07|||MMRM|||Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596313|NCT02942004|2934367|Superiority||LS mean difference|-0.33|Standard Error of the Mean|0.154||0.0354|2-Sided|95.0|-0.63|-0.02|||MMRM|||Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596314|NCT02942004|2934367|Superiority||LS mean difference|-0.13|Standard Error of the Mean|0.157||0.4028|2-Sided|95.0|-0.44|0.18|||MMRM|||Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596315|NCT02942004|2934367|Superiority||LS mean difference|-0.28|Standard Error of the Mean|0.152||0.0692|2-Sided|95.0|-0.58|0.02|||MMRM|||Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596316|NCT02942004|2934367|Superiority||LS mean difference|-0.11|Standard Error of the Mean|0.156||0.4842|2-Sided|95.0|-0.42|0.2|||MMRM|||Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596317|NCT02942004|2934367|Superiority||LS mean difference|-0.28|Standard Error of the Mean|0.145||0.0573|2-Sided|95.0|-0.57|0.01|||MMRM|||Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596318|NCT02942004|2934367|Superiority||LS mean difference|-0.23|Standard Error of the Mean|0.15||0.1278|2-Sided|95.0|-0.53|0.07|||MMRM|||Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596319|NCT02942004|2934367|Superiority||LS mean difference|-0.12|Standard Error of the Mean|0.141||0.4071|2-Sided|95.0|-0.4|0.16|||MMRM|||Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596320|NCT02942004|2934367|Superiority||LS mean difference|-0.12|Standard Error of the Mean|0.145||0.4167|2-Sided|95.0|-0.4|0.17|||MMRM|||Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596321|NCT02942004|2934367|Superiority||LS mean difference|-0.17|Standard Error of the Mean|0.107||0.1121|2-Sided|95.0|-0.38|0.04|||MMRM|||Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596322|NCT02942004|2934367|Superiority||LS mean difference|-0.01|Standard Error of the Mean|0.11||0.9005|2-Sided|95.0|-0.23|0.2|||MMRM|||Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596323|NCT02942004|2934367|Superiority||LS mean difference|-0.09|Standard Error of the Mean|0.123||0.4628|2-Sided|95.0|-0.33|0.15|||MMRM|||Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596324|NCT02942004|2934367|Superiority||LS mean difference|-0.09|Standard Error of the Mean|0.126||0.4631|2-Sided|95.0|-0.34|0.16|||MMRM|||Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596325|NCT02942004|2934367|Superiority||LS mean difference|-0.14|Standard Error of the Mean|0.094||0.1511|2-Sided|95.0|-0.32|0.05|||MMRM|||Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596326|NCT02942004|2934367|Superiority||LS mean difference|-0.11|Standard Error of the Mean|0.097||0.2582|2-Sided|95.0|-0.3|0.08|||MMRM|||Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596327|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.076||0.0384|2-Sided|95.0|-0.31|-0.01|||MMRM|||Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596328|NCT02942004|2934367|Superiority||LS mean difference|0.0|Standard Error of the Mean|0.079||0.9552|2-Sided|95.0|-0.16|0.15|||MMRM|||Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596329|NCT02942004|2934367|Superiority||LS mean difference|-0.29|Standard Error of the Mean|0.185||0.1195|2-Sided|95.0|-0.66|0.08|||MMRM|||Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596330|NCT02942004|2934367|Superiority||LS mean difference|-0.34|Standard Error of the Mean|0.189||0.0719|2-Sided|95.0|-0.72|0.03|||MMRM|||Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596331|NCT02942004|2934367|Superiority||LS mean difference|-0.17|Standard Error of the Mean|0.196||0.3887|2-Sided|95.0|-0.56|0.22|||MMRM|||Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596332|NCT02942004|2934367|Superiority||LS mean difference|-0.49|Standard Error of the Mean|0.205||0.0192|2-Sided|95.0|-0.89|-0.08|||MMRM|||Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596333|NCT02942004|2934367|Superiority||LS mean difference|0.05|Standard Error of the Mean|0.197||0.7919|2-Sided|95.0|-0.34|0.44|||MMRM|||Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596334|NCT02942004|2934367|Superiority||LS mean difference|-0.28|Standard Error of the Mean|0.203||0.169|2-Sided|95.0|-0.69|0.12|||MMRM|||Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596335|NCT02942004|2934367|Superiority||LS mean difference|0.01|Standard Error of the Mean|0.17||0.9587|2-Sided|95.0|-0.33|0.35|||MMRM|||Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596336|NCT02942004|2934367|Superiority||LS mean difference|-0.29|Standard Error of the Mean|0.174||0.102|2-Sided|95.0|-0.63|0.06|||MMRM|||Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596337|NCT02942004|2934367|Superiority||LS mean difference|-0.2|Standard Error of the Mean|0.159||0.2174|2-Sided|95.0|-0.51|0.12|||MMRM|||Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596786|NCT02940860|2934420|Other||Risk Difference (RD)|0.29|||||2-Sided|95.0|-0.19|0.77||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the individual trial with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.|
1597105|NCT02918071|2935676|Other||Percentage|96.6|||||2-Sided|95.0|91.41|99.05|||||Percentage of patients who successfully administered benralizumab with an AI at home (Week 16)||
1596338|NCT02942004|2934367|Superiority||LS mean difference|-0.45|Standard Error of the Mean|0.164||0.0069|2-Sided|95.0|-0.77|-0.13|||MMRM|||Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596339|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.157||0.3068|2-Sided|95.0|-0.47|0.15|||MMRM|||Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596340|NCT02942004|2934367|Superiority||LS mean difference|-0.28|Standard Error of the Mean|0.162||0.0855|2-Sided|95.0|-0.6|0.04|||MMRM|||Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596341|NCT02942004|2934367|Superiority||LS mean difference|-0.23|Standard Error of the Mean|0.159||0.145|2-Sided|95.0|-0.55|0.08|||MMRM|||Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596342|NCT02942004|2934367|Superiority||LS mean difference|-0.38|Standard Error of the Mean|0.164||0.0231|2-Sided|95.0|-0.7|-0.05|||MMRM|||Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596343|NCT02942004|2934367|Superiority||LS mean difference|-0.15|Standard Error of the Mean|0.156||0.3549|2-Sided|95.0|-0.45|0.16|||MMRM|||Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596344|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.163||0.7206|2-Sided|95.0|-0.38|0.26|||MMRM|||Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596345|NCT02942004|2934367|Superiority||LS mean difference|0.05|Standard Error of the Mean|0.167||0.7769|2-Sided|95.0|-0.28|0.38|||MMRM|||Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596346|NCT02942004|2934367|Superiority||LS mean difference|-0.07|Standard Error of the Mean|0.172||0.6791|2-Sided|95.0|-0.41|0.27|||MMRM|||Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596347|NCT02942004|2934367|Superiority||LS mean difference|0.01|Standard Error of the Mean|0.152||0.9307|2-Sided|95.0|-0.29|0.31|||MMRM|||Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596348|NCT02942004|2934367|Superiority||LS mean difference|0.0|Standard Error of the Mean|0.157||0.9778|2-Sided|95.0|-0.31|0.32|||MMRM|||Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596349|NCT02942004|2934367|Superiority||LS mean difference|-0.01|Standard Error of the Mean|0.129||0.9321|2-Sided|95.0|-0.27|0.24|||MMRM|||Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596787|NCT02940860|2934420|Other||95% two-sided CI (iron isomaltoside)|0.3|||||2-Sided|95.0|0.06|0.86||||||"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose, the power was 88% to demonstrate that the upper bound of the 95% CI of the incidence of treatment-emergent serious and/or severe non-serious hypersensitivity AEs was less than 3%.~The significance level was set to 5%."|
1597148|NCT02915835|2935766|Superiority|||||||0.04|||||||ANCOVA||||
1596350|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.133||0.6678|2-Sided|95.0|-0.32|0.21|||MMRM|||Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596351|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.129||0.6437|2-Sided|95.0|-0.32|0.2|||MMRM|||Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596352|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.133||0.2254|2-Sided|95.0|-0.43|0.1|||MMRM|||Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596353|NCT02942004|2934367|Superiority||LS mean difference|0.09|Standard Error of the Mean|0.119||0.4559|2-Sided|95.0|-0.15|0.32|||MMRM|||Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596354|NCT02942004|2934367|Superiority||LS mean difference|-0.05|Standard Error of the Mean|0.123||0.6779|2-Sided|95.0|-0.3|0.19|||MMRM|||Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596355|NCT02942004|2934367|Superiority||LS mean difference|-0.09|Standard Error of the Mean|0.16||0.5609|2-Sided|95.0|-0.41|0.22|||MMRM|||Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596356|NCT02942004|2934367|Superiority||LS mean difference|-0.32|Standard Error of the Mean|0.165||0.0531|2-Sided|95.0|-0.65|0.0|||MMRM|||Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596357|NCT02942004|2934367|Superiority||LS mean difference|-0.21|Standard Error of the Mean|0.188||0.2683|2-Sided|95.0|-0.58|0.16|||MMRM|||Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596358|NCT02942004|2934367|Superiority||LS mean difference|-0.47|Standard Error of the Mean|0.197||0.0202|2-Sided|95.0|-0.86|-0.07|||MMRM|||Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596359|NCT02942004|2934367|Superiority||LS mean difference|-0.12|Standard Error of the Mean|0.18||0.4935|2-Sided|95.0|-0.48|0.23|||MMRM|||Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596360|NCT02942004|2934367|Superiority||LS mean difference|-0.26|Standard Error of the Mean|0.186||0.1669|2-Sided|95.0|-0.63|0.11|||MMRM|||Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596361|NCT02942004|2934367|Superiority||LS mean difference|-0.03|Standard Error of the Mean|0.161||0.8516|2-Sided|95.0|-0.35|0.29|||MMRM|||Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596807|NCT02938520|2934596|Other||Adjusted difference|0.182||||0.645|2-Sided|95.0|-0.594|0.958|||ANCOVA||Treatment comparison of SF-12 PCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1597149|NCT02915835|2935767|Superiority|||||||0.36|||||||ANCOVA||||
1596362|NCT02942004|2934367|Superiority||LS mean difference|-0.37|Standard Error of the Mean|0.166||0.0276|2-Sided|95.0|-0.7|-0.04|||MMRM|||Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596363|NCT02942004|2934367|Superiority||LS mean difference|-0.33|Standard Error of the Mean|0.143||0.0223|2-Sided|95.0|-0.61|-0.05|||MMRM|||Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596364|NCT02942004|2934367|Superiority||LS mean difference|-0.56|Standard Error of the Mean|0.148||0.0003|2-Sided|95.0|-0.85|-0.26|||MMRM|||Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596365|NCT02942004|2934367|Superiority||LS mean difference|-0.14|Standard Error of the Mean|0.14||0.31|2-Sided|95.0|-0.42|0.14|||MMRM|||Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596366|NCT02942004|2934367|Superiority||LS mean difference|-0.43|Standard Error of the Mean|0.145||0.004|2-Sided|95.0|-0.71|-0.14|||MMRM|||Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596367|NCT02942004|2934367|Superiority||LS mean difference|-0.23|Standard Error of the Mean|0.154||0.1379|2-Sided|95.0|-0.54|0.08|||MMRM|||Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596368|NCT02942004|2934367|Superiority||LS mean difference|-0.55|Standard Error of the Mean|0.159||0.0008|2-Sided|95.0|-0.87|-0.24|||MMRM|||Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596369|NCT02942004|2934367|Superiority||LS mean difference|-0.25|Standard Error of the Mean|0.156||0.1182|2-Sided|95.0|-0.56|0.06|||MMRM|||Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596370|NCT02942004|2934367|Superiority||LS mean difference|-0.61|Standard Error of the Mean|0.163||0.0003|2-Sided|95.0|-0.93|-0.28|||MMRM|||Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596371|NCT02942004|2934367|Superiority||LS mean difference|-0.32|Standard Error of the Mean|0.16||0.0482|2-Sided|95.0|-0.64|0.0|||MMRM|||Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596372|NCT02942004|2934367|Superiority||LS mean difference|-0.41|Standard Error of the Mean|0.166||0.015|2-Sided|95.0|-0.74|-0.08|||MMRM|||Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596373|NCT02942004|2934367|Superiority||LS mean difference|-0.05|Standard Error of the Mean|0.157||0.7554|2-Sided|95.0|-0.36|0.26|||MMRM|||Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596808|NCT02938520|2934596|Other||Adjusted difference|1.103||||0.109|2-Sided|95.0|-0.248|2.453|||ANCOVA||Treatment comparison of SF-12 MCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1597150|NCT02915835|2935768|Superiority|||||||0.34|||||||ANCOVA||||
1596374|NCT02942004|2934367|Superiority||LS mean difference|-0.28|Standard Error of the Mean|0.162||0.0919|2-Sided|95.0|-0.6|0.05|||MMRM|||Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596375|NCT02942004|2934367|Superiority||LS mean difference|-0.14|Standard Error of the Mean|0.153||0.3461|2-Sided|95.0|-0.45|0.16|||MMRM|||Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596376|NCT02942004|2934367|Superiority||LS mean difference|-0.18|Standard Error of the Mean|0.158||0.2466|2-Sided|95.0|-0.5|0.13|||MMRM|||Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596377|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.143||0.2607|2-Sided|95.0|-0.45|0.12|||MMRM|||Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596378|NCT02942004|2934367|Superiority||LS mean difference|-0.27|Standard Error of the Mean|0.149||0.071|2-Sided|95.0|-0.57|0.02|||MMRM|||Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596379|NCT02942004|2934367|Superiority||LS mean difference|-0.02|Standard Error of the Mean|0.154||0.9183|2-Sided|95.0|-0.32|0.29|||MMRM|||Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596380|NCT02942004|2934367|Superiority||LS mean difference|-0.01|Standard Error of the Mean|0.159||0.9609|2-Sided|95.0|-0.32|0.31|||MMRM|||Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596381|NCT02942004|2934367|Superiority||LS mean difference|-0.19|Standard Error of the Mean|0.218||0.3785|2-Sided|95.0|-0.62|0.24|||MMRM|||Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596382|NCT02942004|2934367|Superiority||LS mean difference|-0.61|Standard Error of the Mean|0.222||0.007|2-Sided|95.0|-1.05|-0.17|||MMRM|||Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596383|NCT02942004|2934367|Superiority||LS mean difference|-0.12|Standard Error of the Mean|0.22||0.6019|2-Sided|95.0|-0.55|0.32|||MMRM|||Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596384|NCT02942004|2934367|Superiority||LS mean difference|-0.46|Standard Error of the Mean|0.231||0.0504|2-Sided|95.0|-0.91|0.0|||MMRM|||Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596385|NCT02942004|2934367|Superiority||LS mean difference|-0.19|Standard Error of the Mean|0.218||0.3988|2-Sided|95.0|-0.62|0.25|||MMRM|||Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596809|NCT02938520|2934596|Other||Adjusted difference|1.021||||0.122|2-Sided|95.0|-0.275|2.318|||ANCOVA||Treatment comparison of SF-12 MCS at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1597151|NCT02915835|2935770|Superiority|||||||0.55|||||||ANCOVA||||
1596386|NCT02942004|2934367|Superiority||LS mean difference|-0.38|Standard Error of the Mean|0.226||0.0912|2-Sided|95.0|-0.83|0.06|||MMRM|||Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596387|NCT02942004|2934367|Superiority||LS mean difference|-0.08|Standard Error of the Mean|0.188||0.6826|2-Sided|95.0|-0.45|0.3|||MMRM|||Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596388|NCT02942004|2934367|Superiority||LS mean difference|-0.37|Standard Error of the Mean|0.193||0.0581|2-Sided|95.0|-0.75|0.01|||MMRM|||Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596389|NCT02942004|2934367|Superiority||LS mean difference|-0.38|Standard Error of the Mean|0.185||0.0415|2-Sided|95.0|-0.75|-0.01|||MMRM|||Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596390|NCT02942004|2934367|Superiority||LS mean difference|-0.67|Standard Error of the Mean|0.19||0.0006|2-Sided|95.0|-1.05|-0.3|||MMRM|||Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596391|NCT02942004|2934367|Superiority||LS mean difference|-0.31|Standard Error of the Mean|0.171||0.0775|2-Sided|95.0|-0.64|0.03|||MMRM|||Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596392|NCT02942004|2934367|Superiority||LS mean difference|-0.58|Standard Error of the Mean|0.176||0.0013|2-Sided|95.0|-0.93|-0.23|||MMRM|||Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596393|NCT02942004|2934367|Superiority||LS mean difference|-0.34|Standard Error of the Mean|0.176||0.0555|2-Sided|95.0|-0.69|0.01|||MMRM|||Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596394|NCT02942004|2934367|Superiority||LS mean difference|-0.56|Standard Error of the Mean|0.181||0.0025|2-Sided|95.0|-0.92|-0.2|||MMRM|||Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596395|NCT02942004|2934367|Superiority||LS mean difference|-0.22|Standard Error of the Mean|0.178||0.2266|2-Sided|95.0|-0.57|0.14|||MMRM|||Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596396|NCT02942004|2934367|Superiority||LS mean difference|-0.47|Standard Error of the Mean|0.185||0.0118|2-Sided|95.0|-0.84|-0.11|||MMRM|||Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596397|NCT02942004|2934367|Superiority||LS mean difference|-0.35|Standard Error of the Mean|0.161||0.03|2-Sided|95.0|-0.67|-0.03|||MMRM|||Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596599|NCT02942004|2934367|Superiority||LS men difference|-0.17|Standard Error of the Mean|0.092||0.0616|2-Sided|95.0|-0.35|0.01|||MMRM|||Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596398|NCT02942004|2934367|Superiority||LS mean difference|-0.47|Standard Error of the Mean|0.166||0.0055|2-Sided|95.0|-0.8|-0.14|||MMRM|||Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596399|NCT02942004|2934367|Superiority||LS mean difference|-0.05|Standard Error of the Mean|0.182||0.7921|2-Sided|95.0|-0.41|0.31|||MMRM|||Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596400|NCT02942004|2934367|Superiority||LS mean difference|-0.3|Standard Error of the Mean|0.188||0.1091|2-Sided|95.0|-0.68|0.07|||MMRM|||Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596401|NCT02942004|2934367|Superiority||LS mean difference|-0.26|Standard Error of the Mean|0.189||0.1794|2-Sided|95.0|-0.63|0.12|||MMRM|||Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596402|NCT02942004|2934367|Superiority||LS mean difference|-0.43|Standard Error of the Mean|0.195||0.0283|2-Sided|95.0|-0.82|-0.05|||MMRM|||Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596403|NCT02942004|2934367|Superiority||LS mean difference|-0.02|Standard Error of the Mean|0.202||0.9396|2-Sided|95.0|-0.42|0.39|||MMRM|||Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596404|NCT02942004|2934367|Superiority||LS mean difference|-0.23|Standard Error of the Mean|0.208||0.2684|2-Sided|95.0|-0.64|0.18|||MMRM|||Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596405|NCT02942004|2934367|Superiority||LS mean difference|-0.2|Standard Error of the Mean|0.186||0.2945|2-Sided|95.0|-0.56|0.17|||MMRM|||Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596406|NCT02942004|2934367|Superiority||LS mean difference|-0.11|Standard Error of the Mean|0.191||0.5582|2-Sided|95.0|-0.49|0.27|||MMRM|||Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596407|NCT02942004|2934367|Superiority||LS mean difference|-0.28|Standard Error of the Mean|0.23||0.2321|2-Sided|95.0|-0.73|0.18|||MMRM|||Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596408|NCT02942004|2934367|Superiority||LS mean difference|-0.3|Standard Error of the Mean|0.235||0.2066|2-Sided|95.0|-0.76|0.17|||MMRM|||Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596409|NCT02942004|2934367|Superiority||LS mean difference|-0.17|Standard Error of the Mean|0.281||0.5498|2-Sided|95.0|-0.73|0.39|||MMRM|||Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596410|NCT02942004|2934367|Superiority||LS mean difference|-0.09|Standard Error of the Mean|0.293||0.7617|2-Sided|95.0|-0.67|0.49|||MMRM|||Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596411|NCT02942004|2934367|Superiority||LS mean difference|0.24|Standard Error of the Mean|0.263||0.3596|2-Sided|95.0|-0.28|0.76|||MMRM|||Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596412|NCT02942004|2934367|Superiority||LS mean difference|-0.04|Standard Error of the Mean|0.272||0.8908|2-Sided|95.0|-0.58|0.5|||MMRM|||Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596413|NCT02942004|2934367|Superiority||LS mean difference|-0.05|Standard Error of the Mean|0.21||0.811|2-Sided|95.0|-0.47|0.36|||MMRM|||Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596414|NCT02942004|2934367|Superiority||LS mean difference|-0.19|Standard Error of the Mean|0.215||0.378|2-Sided|95.0|-0.62|0.24|||MMRM|||Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596415|NCT02942004|2934367|Superiority||LS mean difference|-0.05|Standard Error of the Mean|0.213||0.8022|2-Sided|95.0|-0.48|0.37|||MMRM|||Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596416|NCT02942004|2934367|Superiority||LS mean difference|-0.29|Standard Error of the Mean|0.219||0.1899|2-Sided|95.0|-0.72|0.15|||MMRM|||Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596417|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.198||0.4283|2-Sided|95.0|-0.55|0.24|||MMRM|||Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596418|NCT02942004|2934367|Superiority||LS mean difference|-0.49|Standard Error of the Mean|0.204||0.0179|2-Sided|95.0|-0.89|-0.09|||MMRM|||Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596419|NCT02942004|2934367|Superiority||LS mean difference|-0.29|Standard Error of the Mean|0.209||0.1622|2-Sided|95.0|-0.71|0.12|||MMRM|||Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596420|NCT02942004|2934367|Superiority||LS mean difference|-0.45|Standard Error of the Mean|0.215||0.0388|2-Sided|95.0|-0.87|-0.02|||MMRM|||Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596421|NCT02942004|2934367|Superiority||LS mean difference|-0.04|Standard Error of the Mean|0.208||0.8308|2-Sided|95.0|-0.46|0.37|||MMRM|||Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596422|NCT02942004|2934367|Superiority||LS mean difference|-0.63|Standard Error of the Mean|0.216||0.0044|2-Sided|95.0|-1.05|-0.2|||MMRM|||Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596677|NCT02942004|2934369|Superiority||Odds Ratio (OR)|2.6||||0.0828|2-Sided|95.0|0.9|7.6|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.|
1596423|NCT02942004|2934367|Superiority||LS mean difference|-0.43|Standard Error of the Mean|0.206||0.0386|2-Sided|95.0|-0.84|-0.02|||MMRM|||Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596424|NCT02942004|2934367|Superiority||LS mean difference|-0.63|Standard Error of the Mean|0.213||0.0037|2-Sided|95.0|-1.05|-0.21|||MMRM|||Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596425|NCT02942004|2934367|Superiority||LS mean difference|0.04|Standard Error of the Mean|0.216||0.8571|2-Sided|95.0|-0.39|0.47|||MMRM|||Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596426|NCT02942004|2934367|Superiority||LS mean difference|-0.13|Standard Error of the Mean|0.223||0.5616|2-Sided|95.0|-0.57|0.31|||MMRM|||Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596427|NCT02942004|2934367|Superiority||LS mean difference|0.03|Standard Error of the Mean|0.225||0.8953|2-Sided|95.0|-0.42|0.48|||MMRM|||Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596428|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.231||0.4809|2-Sided|95.0|-0.62|0.29|||MMRM|||Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596429|NCT02942004|2934367|Superiority||LS mean difference|-0.22|Standard Error of the Mean|0.221||0.3185|2-Sided|95.0|-0.66|0.22|||MMRM|||Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596430|NCT02942004|2934367|Superiority||LS mean difference|-0.35|Standard Error of the Mean|0.227||0.1212|2-Sided|95.0|-0.8|0.1|||MMRM|||Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596431|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.187||0.3992|2-Sided|95.0|-0.53|0.21|||MMRM|||Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596432|NCT02942004|2934367|Superiority||LS mean difference|-0.1|Standard Error of the Mean|0.192||0.5888|2-Sided|95.0|-0.49|0.28|||MMRM|||Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596433|NCT02942004|2934367|Superiority||LS mean difference|0.02|Standard Error of the Mean|0.162||0.8859|2-Sided|95.0|-0.3|0.34|||MMRM|||Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596434|NCT02942004|2934367|Superiority||LS mean difference|-0.15|Standard Error of the Mean|0.164||0.3562|2-Sided|95.0|-0.48|0.17|||MMRM|||Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596435|NCT02942004|2934367|Superiority||LS mean difference|-0.14|Standard Error of the Mean|0.203||0.4791|2-Sided|95.0|-0.55|0.26|||MMRM|||Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596436|NCT02942004|2934367|Superiority||LS mean difference|-0.08|Standard Error of the Mean|0.213||0.7172|2-Sided|95.0|-0.5|0.35|||MMRM|||Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596437|NCT02942004|2934367|Superiority||LS mean difference|0.05|Standard Error of the Mean|0.163||0.7776|2-Sided|95.0|-0.28|0.37|||MMRM|||Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596438|NCT02942004|2934367|Superiority||LS mean difference|0.12|Standard Error of the Mean|0.168||0.4754|2-Sided|95.0|-0.21|0.46|||MMRM|||Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596439|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.137||0.6554|2-Sided|95.0|-0.33|0.21|||MMRM|||Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596440|NCT02942004|2934367|Superiority||LS mean difference|-0.18|Standard Error of the Mean|0.14||0.2018|2-Sided|95.0|-0.46|0.1|||MMRM|||Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596441|NCT02942004|2934367|Superiority||LS mean difference|-0.17|Standard Error of the Mean|0.158||0.2818|2-Sided|95.0|-0.48|0.14|||MMRM|||Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596442|NCT02942004|2934367|Superiority||LS mean difference|-0.2|Standard Error of the Mean|0.162||0.2115|2-Sided|95.0|-0.52|0.12|||MMRM|||Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596443|NCT02942004|2934367|Superiority||LS mean difference|-0.12|Standard Error of the Mean|0.148||0.4317|2-Sided|95.0|-0.41|0.18|||MMRM|||Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596444|NCT02942004|2934367|Superiority||LS mean difference|-0.28|Standard Error of the Mean|0.151||0.0716|2-Sided|95.0|-0.58|0.02|||MMRM|||Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596445|NCT02942004|2934367|Superiority||LS mean difference|-0.04|Standard Error of the Mean|0.137||0.7713|2-Sided|95.0|-0.31|0.23|||MMRM|||Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596446|NCT02942004|2934367|Superiority||LS mean difference|-0.04|Standard Error of the Mean|0.141||0.7768|2-Sided|95.0|-0.32|0.24|||MMRM|||Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596447|NCT02942004|2934367|Superiority||LS mean difference|-0.11|Standard Error of the Mean|0.157||0.484|2-Sided|95.0|-0.42|0.2|||MMRM|||Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596448|NCT02942004|2934367|Superiority||LS mean difference|-0.19|Standard Error of the Mean|0.162||0.24|2-Sided|95.0|-0.51|0.13|||MMRM|||Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1597152|NCT02915835|2935771|Superiority|||||||0.84|||||||ANCOVA||||
1596449|NCT02942004|2934367|Superiority||LS mean difference|-0.15|Standard Error of the Mean|0.151||0.3128|2-Sided|95.0|-0.45|0.15|||MMRM|||Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596450|NCT02942004|2934367|Superiority||LS mean difference|-0.32|Standard Error of the Mean|0.155||0.0404|2-Sided|95.0|-0.63|-0.01|||MMRM|||Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596451|NCT02942004|2934367|Superiority||LS mean difference|-0.04|Standard Error of the Mean|0.161||0.817|2-Sided|95.0|-0.36|0.28|||MMRM|||Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596452|NCT02942004|2934367|Superiority||LS mean difference|-0.1|Standard Error of the Mean|0.165||0.5665|2-Sided|95.0|-0.42|0.23|||MMRM|||Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596453|NCT02942004|2934367|Superiority||LS mean difference|-0.04|Standard Error of the Mean|0.158||0.8022|2-Sided|95.0|-0.35|0.27|||MMRM|||Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596454|NCT02942004|2934367|Superiority||LS mean difference|-0.17|Standard Error of the Mean|0.162||0.3022|2-Sided|95.0|-0.49|0.15|||MMRM|||Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596455|NCT02942004|2934367|Superiority||LS mean difference|0.03|Standard Error of the Mean|0.144||0.8286|2-Sided|95.0|-0.25|0.32|||MMRM|||Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596456|NCT02942004|2934367|Superiority||LS mean difference|-0.15|Standard Error of the Mean|0.147||0.3201|2-Sided|95.0|-0.44|0.15|||MMRM|||Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596457|NCT02942004|2934367|Superiority||LS mean difference|0.01|Standard Error of the Mean|0.151||0.9401|2-Sided|95.0|-0.29|0.31|||MMRM|||Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596458|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.155||0.7177|2-Sided|95.0|-0.36|0.25|||MMRM|||Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596459|NCT02942004|2934367|Superiority||LS mean difference|-0.25|Standard Error of the Mean|0.126||0.0495|2-Sided|95.0|-0.5|0.0|||MMRM|||Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596460|NCT02942004|2934367|Superiority||LS mean difference|-0.42|Standard Error of the Mean|0.129||0.0016|2-Sided|95.0|-0.67|-0.16|||MMRM|||Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596461|NCT02942004|2934367|Superiority||LS mean difference|-0.09|Standard Error of the Mean|0.147||0.5629|2-Sided|95.0|-0.38|0.21|||MMRM|||Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596462|NCT02942004|2934367|Superiority||LS mean difference|-0.33|Standard Error of the Mean|0.153||0.0341|2-Sided|95.0|-0.63|-0.03|||MMRM|||Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596463|NCT02942004|2934367|Superiority||LS mean difference|-0.03|Standard Error of the Mean|0.167||0.8767|2-Sided|95.0|-0.36|0.31|||MMRM|||Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596464|NCT02942004|2934367|Superiority||LS mean difference|-0.13|Standard Error of the Mean|0.172||0.4383|2-Sided|95.0|-0.48|0.21|||MMRM|||Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596465|NCT02942004|2934367|Superiority||LS mean difference|-0.03|Standard Error of the Mean|0.129||0.7864|2-Sided|95.0|-0.29|0.22|||MMRM|||Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596466|NCT02942004|2934367|Superiority||LS mean difference|-0.35|Standard Error of the Mean|0.132||0.0086|2-Sided|95.0|-0.61|-0.09|||MMRM|||Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596467|NCT02942004|2934367|Superiority||LS mean difference|-0.14|Standard Error of the Mean|0.129||0.2874|2-Sided|95.0|-0.4|0.12|||MMRM|||Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596468|NCT02942004|2934367|Superiority||LS mean difference|-0.2|Standard Error of the Mean|0.133||0.1347|2-Sided|95.0|-0.46|0.06|||MMRM|||Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596469|NCT02942004|2934367|Superiority||LS mean difference|0.02|Standard Error of the Mean|0.127||0.879|2-Sided|95.0|-0.23|0.27|||MMRM|||Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596470|NCT02942004|2934367|Superiority||LS mean difference|-0.08|Standard Error of the Mean|0.13||0.5292|2-Sided|95.0|-0.34|0.18|||MMRM|||Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596471|NCT02942004|2934367|Superiority||LS mean difference|-0.03|Standard Error of the Mean|0.138||0.827|2-Sided|95.0|-0.3|0.24|||MMRM|||Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596472|NCT02942004|2934367|Superiority||LS mean difference|-0.13|Standard Error of the Mean|0.142||0.3579|2-Sided|95.0|-0.41|0.15|||MMRM|||Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596473|NCT02942004|2934367|Superiority||LS mean difference|0.06|Standard Error of the Mean|0.146||0.6834|2-Sided|95.0|-0.23|0.35|||MMRM|||Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596474|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.151||0.2908|2-Sided|95.0|-0.46|0.14|||MMRM|||Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596475|NCT02942004|2934367|Superiority||LS mean difference|0.01|Standard Error of the Mean|0.129||0.9459|2-Sided|95.0|-0.25|0.26|||MMRM|||Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596476|NCT02942004|2934367|Superiority||LS mean difference|0.01|Standard Error of the Mean|0.133||0.9284|2-Sided|95.0|-0.25|0.28|||MMRM|||Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596477|NCT02942004|2934367|Superiority||LS mean difference|0.16|Standard Error of the Mean|0.14||0.2634|2-Sided|95.0|-0.12|0.43|||MMRM|||Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596478|NCT02942004|2934367|Superiority||LS mean difference|0.1|Standard Error of the Mean|0.144||0.4932|2-Sided|95.0|-0.19|0.39|||MMRM|||Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596479|NCT02942004|2934367|Superiority||LS mean difference|0.21|Standard Error of the Mean|0.129||0.1069|2-Sided|95.0|-0.05|0.46|||MMRM|||Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596480|NCT02942004|2934367|Superiority||LS mean difference|0.16|Standard Error of the Mean|0.132||0.2255|2-Sided|95.0|-0.1|0.42|||MMRM|||Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596481|NCT02942004|2934367|Superiority||LS mean difference|0.31|Standard Error of the Mean|0.126||0.0159|2-Sided|95.0|0.06|0.56|||MMRM|||Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596482|NCT02942004|2934367|Superiority||LS mean difference|0.32|Standard Error of the Mean|0.129||0.0142|2-Sided|95.0|0.07|0.58|||MMRM|||Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596483|NCT02942004|2934367|Superiority||LS mean difference|0.17|Standard Error of the Mean|0.118||0.1537|2-Sided|95.0|-0.06|0.4|||MMRM|||Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596484|NCT02942004|2934367|Superiority||LS mean difference|0.34|Standard Error of the Mean|0.121||0.0056|2-Sided|95.0|0.1|0.58|||MMRM|||Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596485|NCT02942004|2934367|Superiority||LS mean difference|-0.37|Standard Error of the Mean|0.249||0.1352|2-Sided|95.0|-0.87|0.12|||MMRM|||Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596486|NCT02942004|2934367|Superiority||LS mean difference|-0.53|Standard Error of the Mean|0.254||0.0404|2-Sided|95.0|-1.03|-0.02|||MMRM|||Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596678|NCT02942004|2934369|Superiority||Odds Ratio (OR)|6.0||||0.0011|2-Sided|95.0|2.1|17.8|||GEE method|||Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.|
1596487|NCT02942004|2934367|Superiority||LS mean difference|-0.52|Standard Error of the Mean|0.273||0.0583|2-Sided|95.0|-1.06|0.02|||MMRM|||Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596488|NCT02942004|2934367|Superiority||LS mean difference|-0.61|Standard Error of the Mean|0.285||0.036|2-Sided|95.0|-1.17|-0.04|||MMRM|||Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596489|NCT02942004|2934367|Superiority||LS mean difference|-0.03|Standard Error of the Mean|0.283||0.9266|2-Sided|95.0|-0.59|0.54|||MMRM|||Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596490|NCT02942004|2934367|Superiority||LS mean difference|0.01|Standard Error of the Mean|0.292||0.9861|2-Sided|95.0|-0.57|0.58|||MMRM|||Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596491|NCT02942004|2934367|Superiority||LS mean difference|-0.17|Standard Error of the Mean|0.249||0.4865|2-Sided|95.0|-0.67|0.32|||MMRM|||Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596492|NCT02942004|2934367|Superiority||LS mean difference|-0.43|Standard Error of the Mean|0.254||0.095|2-Sided|95.0|-0.93|0.08|||MMRM|||Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596493|NCT02942004|2934367|Superiority||LS mean difference|0.01|Standard Error of the Mean|0.232||0.9824|2-Sided|95.0|-0.46|0.47|||MMRM|||Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596494|NCT02942004|2934367|Superiority||LS mean difference|-0.51|Standard Error of the Mean|0.238||0.0339|2-Sided|95.0|-0.98|-0.04|||MMRM|||Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596495|NCT02942004|2934367|Superiority||LS mean difference|-0.24|Standard Error of the Mean|0.242||0.3226|2-Sided|95.0|-0.72|0.24|||MMRM|||Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596496|NCT02942004|2934367|Superiority||LS mean difference|-0.58|Standard Error of the Mean|0.248||0.0215|2-Sided|95.0|-1.07|-0.09|||MMRM|||Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596497|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.253||0.8101|2-Sided|95.0|-0.56|0.44|||MMRM|||Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596498|NCT02942004|2934367|Superiority||LS mean difference|-0.29|Standard Error of the Mean|0.26||0.2646|2-Sided|95.0|-0.81|0.22|||MMRM|||Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596810|NCT02938520|2934597|Other||Adjusted difference|-4.6||||0.033|2-Sided|95.0|-8.9|-0.4|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1597153|NCT02915835|2935772|Superiority|||||||0.35|||||||ANCOVA||||
1596499|NCT02942004|2934367|Superiority||LS mean difference|0.3|Standard Error of the Mean|0.228||0.1842|2-Sided|95.0|-0.15|0.76|||MMRM|||Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596500|NCT02942004|2934367|Superiority||LS mean difference|-0.38|Standard Error of the Mean|0.236||0.112|2-Sided|95.0|-0.84|0.09|||MMRM|||Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596501|NCT02942004|2934367|Superiority||LS mean difference|0.03|Standard Error of the Mean|0.238||0.8949|2-Sided|95.0|-0.44|0.5|||MMRM|||Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596502|NCT02942004|2934367|Superiority||LS mean difference|-0.13|Standard Error of the Mean|0.244||0.6081|2-Sided|95.0|-0.61|0.36|||MMRM|||Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596503|NCT02942004|2934367|Superiority||LS mean difference|0.19|Standard Error of the Mean|0.225||0.3947|2-Sided|95.0|-0.25|0.64|||MMRM|||Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596504|NCT02942004|2934367|Superiority||LS mean difference|-0.18|Standard Error of the Mean|0.232||0.4312|2-Sided|95.0|-0.64|0.28|||MMRM|||Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596505|NCT02942004|2934367|Superiority||LS mean difference|0.14|Standard Error of the Mean|0.225||0.5278|2-Sided|95.0|-0.3|0.59|||MMRM|||Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596506|NCT02942004|2934367|Superiority||LS mean difference|-0.14|Standard Error of the Mean|0.23||0.5431|2-Sided|95.0|-0.6|0.32|||MMRM|||Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596507|NCT02942004|2934367|Superiority||LS mean difference|0.08|Standard Error of the Mean|0.175||0.6334|2-Sided|95.0|-0.26|0.43|||MMRM|||Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596508|NCT02942004|2934367|Superiority||LS mean difference|-0.23|Standard Error of the Mean|0.181||0.2006|2-Sided|95.0|-0.59|0.13|||MMRM|||Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596509|NCT02942004|2934367|Superiority||LS mean difference|0.05|Standard Error of the Mean|0.145||0.7559|2-Sided|95.0|-0.24|0.33|||MMRM|||Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596510|NCT02942004|2934367|Superiority||LS mean difference|-0.13|Standard Error of the Mean|0.15||0.4038|2-Sided|95.0|-0.42|0.17|||MMRM|||Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596811|NCT02938520|2934597|Other||Adjusted difference|-1.3||||0.552|2-Sided|95.0|-5.7|3.0|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1597154|NCT02915835|2935773|Superiority|||||||0.47|||||||ANCOVA||||
1596511|NCT02942004|2934367|Superiority||LS mean difference|-0.32|Standard Error of the Mean|0.189||0.0935|2-Sided|95.0|-0.69|0.05|||MMRM|||Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596512|NCT02942004|2934367|Superiority||LS mean difference|-0.27|Standard Error of the Mean|0.191||0.1668|2-Sided|95.0|-0.65|0.11|||MMRM|||Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596513|NCT02942004|2934367|Superiority||LS mean difference|0.03|Standard Error of the Mean|0.225||0.9081|2-Sided|95.0|-0.42|0.47|||MMRM|||Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596514|NCT02942004|2934367|Superiority||LS mean difference|-0.12|Standard Error of the Mean|0.234||0.622|2-Sided|95.0|-0.58|0.35|||MMRM|||Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596515|NCT02942004|2934367|Superiority||LS mean difference|-0.07|Standard Error of the Mean|0.223||0.7609|2-Sided|95.0|-0.51|0.37|||MMRM|||Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596516|NCT02942004|2934367|Superiority||LS mean difference|-0.17|Standard Error of the Mean|0.23||0.4576|2-Sided|95.0|-0.63|0.28|||MMRM|||Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596517|NCT02942004|2934367|Superiority||LS mean difference|-0.15|Standard Error of the Mean|0.18||0.3951|2-Sided|95.0|-0.51|0.2|||MMRM|||Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596518|NCT02942004|2934367|Superiority||LS mean difference|0.08|Standard Error of the Mean|0.183||0.659|2-Sided|95.0|-0.28|0.44|||MMRM|||Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596519|NCT02942004|2934367|Superiority||LS mean difference|-0.05|Standard Error of the Mean|0.172||0.7727|2-Sided|95.0|-0.39|0.29|||MMRM|||Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596520|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.176||0.7447|2-Sided|95.0|-0.41|0.29|||MMRM|||Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596521|NCT02942004|2934367|Superiority||LS mean difference|-0.33|Standard Error of the Mean|0.172||0.0567|2-Sided|95.0|-0.67|0.01|||MMRM|||Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596522|NCT02942004|2934367|Superiority||LS mean difference|-0.27|Standard Error of the Mean|0.176||0.1264|2-Sided|95.0|-0.62|0.08|||MMRM|||Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596523|NCT02942004|2934367|Superiority||LS mean difference|-0.27|Standard Error of the Mean|0.177||0.136|2-Sided|95.0|-0.62|0.09|||MMRM|||Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596524|NCT02942004|2934367|Superiority||LS mean difference|-0.27|Standard Error of the Mean|0.182||0.1373|2-Sided|95.0|-0.63|0.09|||MMRM|||Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596525|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.18||0.3851|2-Sided|95.0|-0.51|0.2|||MMRM|||Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596526|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.187||0.3811|2-Sided|95.0|-0.53|0.21|||MMRM|||Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596527|NCT02942004|2934367|Superiority||LS mean difference|-0.27|Standard Error of the Mean|0.174||0.1214|2-Sided|95.0|-0.62|0.07|||MMRM|||Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596528|NCT02942004|2934367|Superiority||LS mean difference|-0.26|Standard Error of the Mean|0.179||0.1525|2-Sided|95.0|-0.61|0.1|||MMRM|||Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596529|NCT02942004|2934367|Superiority||LS mean difference|-0.15|Standard Error of the Mean|0.145||0.3091|2-Sided|95.0|-0.44|0.14|||MMRM|||Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596530|NCT02942004|2934367|Superiority||LS mean difference|0.15|Standard Error of the Mean|0.149||0.3031|2-Sided|95.0|-0.14|0.45|||MMRM|||Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596531|NCT02942004|2934367|Superiority||LS mean difference|-0.23|Standard Error of the Mean|0.144||0.1184|2-Sided|95.0|-0.51|0.06|||MMRM|||Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596532|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.148||0.6952|2-Sided|95.0|-0.35|0.23|||MMRM|||Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596533|NCT02942004|2934367|Superiority||LS mean difference|-0.18|Standard Error of the Mean|0.146||0.2236|2-Sided|95.0|-0.47|0.11|||MMRM|||Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596534|NCT02942004|2934367|Superiority||LS mean difference|0.04|Standard Error of the Mean|0.15||0.7689|2-Sided|95.0|-0.25|0.34|||MMRM|||Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596535|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.126||0.6498|2-Sided|95.0|-0.31|0.19|||MMRM|||Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596536|NCT02942004|2934367|Superiority||LS mean difference|0.18|Standard Error of the Mean|0.129||0.1768|2-Sided|95.0|-0.08|0.43|||MMRM|||Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596537|NCT02942004|2934367|Superiority||LS mean difference|-0.21|Standard Error of the Mean|0.195||0.2824|2-Sided|95.0|-0.6|0.18|||MMRM|||Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596538|NCT02942004|2934367|Superiority||LS mean difference|-0.43|Standard Error of the Mean|0.197||0.0299|2-Sided|95.0|-0.82|-0.04|||MMRM|||Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596539|NCT02942004|2934367|Superiority||LS mean difference|-0.14|Standard Error of the Mean|0.209||0.5119|2-Sided|95.0|-0.55|0.28|||MMRM|||Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596540|NCT02942004|2934367|Superiority||LS mean difference|-0.5|Standard Error of the Mean|0.218||0.0245|2-Sided|95.0|-0.93|-0.07|||MMRM|||Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596541|NCT02942004|2934367|Superiority||LS mean difference|-0.26|Standard Error of the Mean|0.21||0.2222|2-Sided|95.0|-0.67|0.16|||MMRM|||Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596542|NCT02942004|2934367|Superiority||LS mean difference|-0.64|Standard Error of the Mean|0.216||0.0041|2-Sided|95.0|-1.07|-0.21|||MMRM|||Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596543|NCT02942004|2934367|Superiority||LS mean difference|0.08|Standard Error of the Mean|0.182||0.6625|2-Sided|95.0|-0.28|0.44|||MMRM|||Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596544|NCT02942004|2934367|Superiority||LS mean difference|-0.1|Standard Error of the Mean|0.185||0.5828|2-Sided|95.0|-0.47|0.26|||MMRM|||Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596545|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.188||0.3945|2-Sided|95.0|-0.53|0.21|||MMRM|||Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596546|NCT02942004|2934367|Superiority||LS mean difference|-0.3|Standard Error of the Mean|0.193||0.1269|2-Sided|95.0|-0.68|0.09|||MMRM|||Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596547|NCT02942004|2934367|Superiority||LS mean difference|-0.4|Standard Error of the Mean|0.185||0.0342|2-Sided|95.0|-0.76|-0.03|||MMRM|||Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596548|NCT02942004|2934367|Superiority||LS mean difference|-0.39|Standard Error of the Mean|0.189||0.0402|2-Sided|95.0|-0.77|-0.02|||MMRM|||Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596679|NCT02942004|2934370|Superiority||Odds Ratio (OR)|2.9||||0.0347|2-Sided|95.0|1.1|7.8|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.|
1596549|NCT02942004|2934367|Superiority||LS mean difference|-0.29|Standard Error of the Mean|0.188||0.1291|2-Sided|95.0|-0.66|0.08|||MMRM|||Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596550|NCT02942004|2934367|Superiority||LS mean difference|-0.27|Standard Error of the Mean|0.192||0.165|2-Sided|95.0|-0.65|0.11|||MMRM|||Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596551|NCT02942004|2934367|Superiority||LS mean difference|-0.28|Standard Error of the Mean|0.185||0.1269|2-Sided|95.0|-0.65|0.08|||MMRM|||Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596552|NCT02942004|2934367|Superiority||LS mean difference|-0.29|Standard Error of the Mean|0.191||0.1347|2-Sided|95.0|-0.66|0.09|||MMRM|||Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596553|NCT02942004|2934367|Superiority||LS mean difference|-0.36|Standard Error of the Mean|0.191||0.0644|2-Sided|95.0|-0.74|0.02|||MMRM|||Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596554|NCT02942004|2934367|Superiority||LS mean difference|-0.41|Standard Error of the Mean|0.197||0.0373|2-Sided|95.0|-0.8|-0.02|||MMRM|||Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596555|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.128||0.6196|2-Sided|95.0|-0.32|0.19|||MMRM|||Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596556|NCT02942004|2934367|Superiority||LS mean difference|-0.02|Standard Error of the Mean|0.132||0.8625|2-Sided|95.0|-0.28|0.24|||MMRM|||Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596557|NCT02942004|2934367|Superiority||LS mean difference|-0.11|Standard Error of the Mean|0.139||0.4163|2-Sided|95.0|-0.39|0.16|||MMRM|||Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596558|NCT02942004|2934367|Superiority||LS mean difference|0.05|Standard Error of the Mean|0.142||0.7332|2-Sided|95.0|-0.23|0.33|||MMRM|||Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596559|NCT02942004|2934367|Superiority||LS mean difference|-0.09|Standard Error of the Mean|0.134||0.521|2-Sided|95.0|-0.35|0.18|||MMRM|||Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596560|NCT02942004|2934367|Superiority||LS mean difference|-0.05|Standard Error of the Mean|0.138||0.7151|2-Sided|95.0|-0.32|0.22|||MMRM|||Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596561|NCT02942004|2934367|Superiority||LS mean difference|-0.04|Standard Error of the Mean|0.101||0.7171|2-Sided|95.0|-0.24|0.16|||MMRM|||Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596562|NCT02942004|2934367|Superiority||LS mean difference|0.16|Standard Error of the Mean|0.104||0.1197|2-Sided|95.0|-0.04|0.37|||MMRM|||Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596563|NCT02942004|2934367|Superiority||LS mean difference|-0.42|Standard Error of the Mean|0.205||0.0443|2-Sided|95.0|-0.83|-0.01|||MMRM|||Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596564|NCT02942004|2934367|Superiority||LS mean difference|-0.67|Standard Error of the Mean|0.208||0.0018|2-Sided|95.0|-1.08|-0.26|||MMRM|||Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596565|NCT02942004|2934367|Superiority||LS mean difference|-0.42|Standard Error of the Mean|0.219||0.057|2-Sided|95.0|-0.86|0.01|||MMRM|||Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596566|NCT02942004|2934367|Superiority||LS mean difference|-0.59|Standard Error of the Mean|0.23||0.0112|2-Sided|95.0|-1.05|-0.14|||MMRM|||Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596567|NCT02942004|2934367|Superiority||LS mean difference|-0.09|Standard Error of the Mean|0.249||0.706|2-Sided|95.0|-0.59|0.4|||MMRM|||Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596568|NCT02942004|2934367|Superiority||LS mean difference|-0.22|Standard Error of the Mean|0.258||0.3861|2-Sided|95.0|-0.74|0.29|||Wilcoxon (Mann-Whitney)|||Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596569|NCT02942004|2934367|Superiority||LS mean difference|-0.29|Standard Error of the Mean|0.206||0.1687|2-Sided|95.0|-0.69|0.12|||MMRM|||Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596570|NCT02942004|2934367|Superiority||LS mean difference|-0.51|Standard Error of the Mean|0.21||0.0173|2-Sided|95.0|-0.92|-0.09|||MMRM|||Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596571|NCT02942004|2934367|Superiority||LS mean difference|-0.34|Standard Error of the Mean|0.202||0.0955|2-Sided|95.0|-0.74|0.06|||MMRM|||Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596572|NCT02942004|2934367|Superiority||LS mean difference|-0.39|Standard Error of the Mean|0.207||0.0622|2-Sided|95.0|-0.8|0.02|||MMRM|||Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596573|NCT02942004|2934367|Superiority||LS mean difference|-0.34|Standard Error of the Mean|0.2||0.0884|2-Sided|95.0|-0.74|0.05|||MMRM|||Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596680|NCT02942004|2934370|Superiority||Odds Ratio (OR)|5.4||||0.0035|2-Sided|95.0|1.7|16.8|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.|
1596574|NCT02942004|2934367|Superiority||LS mean difference|-0.25|Standard Error of the Mean|0.204||0.2293|2-Sided|95.0|-0.65|0.16|||MMRM|||Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596575|NCT02942004|2934367|Superiority||LS mean difference|-0.51|Standard Error of the Mean|0.205||0.0143|2-Sided|95.0|-0.91|-0.1|||MMRM|||Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596576|NCT02942004|2934367|Superiority||LS mean difference|-0.31|Standard Error of the Mean|0.21||0.1402|2-Sided|95.0|-0.73|0.1|||MMRM|||Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596577|NCT02942004|2934367|Superiority||LS mean difference|-0.29|Standard Error of the Mean|0.202||0.1591|2-Sided|95.0|-0.69|0.11|||MMRM|||Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596578|NCT02942004|2934367|Superiority||LS mean difference|-0.61|Standard Error of the Mean|0.208||0.0039|2-Sided|95.0|-1.03|-0.2|||Wilcoxon (Mann-Whitney)|||Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596579|NCT02942004|2934367|Superiority||LS mean difference|-0.41|Standard Error of the Mean|0.196||0.0394|2-Sided|95.0|-0.8|-0.02|||MMRM|||Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596580|NCT02942004|2934367|Superiority||LS mean difference|-0.63|Standard Error of the Mean|0.201||0.0021|2-Sided|95.0|-1.03|-0.23|||MMRM|||Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596581|NCT02942004|2934367|Superiority||LS mean difference|-0.04|Standard Error of the Mean|0.13||0.7534|2-Sided|95.0|-0.3|0.22|||MMRM|||Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596582|NCT02942004|2934367|Superiority||LS mean difference|-0.02|Standard Error of the Mean|0.134||0.8605|2-Sided|95.0|-0.29|0.24|||MMRM|||Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596583|NCT02942004|2934367|Superiority||LS mean difference|-0.07|Standard Error of the Mean|0.145||0.6357|2-Sided|95.0|-0.36|0.22|||MMRM|||Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596584|NCT02942004|2934367|Superiority||LS mean difference|0.12|Standard Error of the Mean|0.148||0.403|2-Sided|95.0|-0.17|0.42|||MMRM|||Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596585|NCT02942004|2934367|Superiority||LS mean difference|0.0|Standard Error of the Mean|0.136||0.9737|2-Sided|95.0|-0.26|0.27|||MMRM|||Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596681|NCT02942004|2934370|Superiority||Odds Ratio (OR)|1.2||||0.6768|2-Sided|95.0|0.5|3.0|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.|
1596586|NCT02942004|2934367|Superiority||LS difference|0.07|Standard Error of the Mean|0.139||0.6066|2-Sided|95.0|-0.2|0.35|||MMRM|||Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596587|NCT02942004|2934367|Superiority||LS mean difference|0.08|Standard Error of the Mean|0.108||0.469|2-Sided|95.0|-0.14|0.29|||MMRM|||Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596588|NCT02942004|2934367|Superiority||LS mean difference|0.23|Standard Error of the Mean|0.112||0.0395|2-Sided|95.0|0.01|0.45|||MMRM|||Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596589|NCT02942004|2934367|Superiority||LS mean difference|-0.12|Standard Error of the Mean|0.115||0.2903|2-Sided|95.0|-0.35|0.11|||MMRM|||Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596590|NCT02942004|2934367|Superiority||LS mean difference|-0.23|Standard Error of the Mean|0.118||0.0545|2-Sided|95.0|-0.46|0.0|||MMRM|||Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596591|NCT02942004|2934367|Superiority||LS mean difference|-0.27|Standard Error of the Mean|0.192||0.1646|2-Sided|95.0|-0.66|0.11|||MMRM|||Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596592|NCT02942004|2934367|Superiority||LS mean difference|-0.19|Standard Error of the Mean|0.201||0.3577|2-Sided|95.0|-0.59|0.22|||MMRM|||Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596593|NCT02942004|2934367|Superiority||LS mean difference|0.12|Standard Error of the Mean|0.121||0.3326|2-Sided|95.0|-0.12|0.36|||MMRM|||Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596594|NCT02942004|2934367|Superiority||LS mean difference|-0.07|Standard Error of the Mean|0.124||0.5655|2-Sided|95.0|-0.32|0.18|||MMRM|||Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596595|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.126||0.6371|2-Sided|95.0|-0.31|0.19|||MMRM|||Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596596|NCT02942004|2934367|Superiority||LS mean difference|-0.18|Standard Error of the Mean|0.129||0.1593|2-Sided|95.0|-0.44|0.07|||MMRM|||Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596597|NCT02942004|2934367|Superiority||LS mean difference|-0.03|Standard Error of the Mean|0.095||0.773|2-Sided|95.0|-0.22|0.16|||MMRM|||Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596598|NCT02942004|2934367|Superiority||LS mean difference|-0.13|Standard Error of the Mean|0.099||0.186|2-Sided|95.0|-0.33|0.06|||MMRM|||Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596600|NCT02942004|2934367|Superiority||LS mean difference|-0.22|Standard Error of the Mean|0.094||0.0209|2-Sided|95.0|-0.41|-0.03|||MMRM|||Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596601|NCT02942004|2934367|Superiority||LS mean difference|-0.08|Standard Error of the Mean|0.088||0.3863|2-Sided|95.0|-0.25|0.1|||MMRM|||Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596602|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.091||0.5148|2-Sided|95.0|-0.24|0.12|||MMRM|||Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596603|NCT02942004|2934367|Superiority||LS mean difference|0.14|Standard Error of the Mean|0.096||0.1345|2-Sided|95.0|-0.05|0.33|||MMRM|||Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596604|NCT02942004|2934367|Superiority||LS mean difference|-0.1|Standard Error of the Mean|0.099||0.3112|2-Sided|95.0|-0.3|0.1|||MMRM|||Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596605|NCT02942004|2934367|Superiority||LS mean difference|0.19|Standard Error of the Mean|0.12||0.1094|2-Sided|95.0|-0.04|0.43|||MMRM|||Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596606|NCT02942004|2934367|Superiority||LS mean difference|-0.08|Standard Error of the Mean|0.124||0.507|2-Sided|95.0|-0.33|0.16|||MMRM|||Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596607|NCT02942004|2934367|Superiority||LS mean difference|0.26|Standard Error of the Mean|0.126||0.038|2-Sided|95.0|0.01|0.51|||MMRM|||Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596608|NCT02942004|2934367|Superiority||LS mean difference|0.03|Standard Error of the Mean|0.129||0.8215|2-Sided|95.0|-0.23|0.29|||MMRM|||Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596609|NCT02942004|2934367|Superiority||LS mean difference|0.17|Standard Error of the Mean|0.125||0.1631|2-Sided|95.0|-0.07|0.42|||MMRM|||Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596610|NCT02942004|2934367|Superiority||LS mean difference|-0.2|Standard Error of the Mean|0.128||0.13|2-Sided|95.0|-0.45|0.06|||MMRM|||Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596611|NCT02942004|2934367|Superiority||LS mean difference|0.04|Standard Error of the Mean|0.139||0.7932|2-Sided|95.0|-0.24|0.31|||MMRM|||Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596612|NCT02942004|2934367|Superiority||LS men difference|-0.28|Standard Error of the Mean|0.142||0.0525|2-Sided|95.0|-0.56|0.0|||MMRM|||Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1597155|NCT02915835|2935774|Superiority|||||||0.82|||||||ANCOVA||||
1596613|NCT02942004|2934367|Superiority||LS mean difference|0.09|Standard Error of the Mean|0.143||0.5351|2-Sided|95.0|-0.19|0.37|||MMRM|||Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596614|NCT02942004|2934367|Superiority||LS mean difference|-0.3|Standard Error of the Mean|0.146||0.045|2-Sided|95.0|-0.59|-0.01|||MMRM|||Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596615|NCT02942004|2934367|Superiority||LS mean difference|-0.22|Standard Error of the Mean|0.213||0.3041|2-Sided|95.0|-0.64|0.2|||MMRM|||Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596616|NCT02942004|2934367|Superiority||LS mean difference|-0.21|Standard Error of the Mean|0.217||0.3275|2-Sided|95.0|-0.64|0.22|||MMRM|||Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596617|NCT02942004|2934367|Superiority||LS mean difference|-0.41|Standard Error of the Mean|0.23||0.0761|2-Sided|95.0|-0.87|0.04|||MMRM|||Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596618|NCT02942004|2934367|Superiority||LS mean difference|-0.41|Standard Error of the Mean|0.24||0.0922|2-Sided|95.0|-0.89|0.07|||MMRM|||Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596619|NCT02942004|2934367|Superiority||LS mean difference|-0.23|Standard Error of the Mean|0.226||0.3134|2-Sided|95.0|-0.68|0.22|||MMRM|||Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596620|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.232||0.4877|2-Sided|95.0|-0.62|0.3|||MMRM|||Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596621|NCT02942004|2934367|Superiority||LS mean difference|-0.18|Standard Error of the Mean|0.214||0.4035|2-Sided|95.0|-0.6|0.24|||MMRM|||Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596622|NCT02942004|2934367|Superiority||LS mean difference|-0.2|Standard Error of the Mean|0.22||0.3645|2-Sided|95.0|-0.64|0.24|||MMRM|||Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596623|NCT02942004|2934367|Superiority||LS mean difference|-0.16|Standard Error of the Mean|0.204||0.4444|2-Sided|95.0|-0.56|0.25|||MMRM|||Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596624|NCT02942004|2934367|Superiority||LS mean difference|-0.27|Standard Error of the Mean|0.21||0.2023|2-Sided|95.0|-0.69|0.15|||MMRM|||Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596625|NCT02942004|2934367|Superiority||LS mean difference|-0.4|Standard Error of the Mean|0.209||0.0577|2-Sided|95.0|-0.81|0.01|||MMRM|||Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596626|NCT02942004|2934367|Superiority||LS mean difference|-0.45|Standard Error of the Mean|0.215||0.0373|2-Sided|95.0|-0.88|-0.03|||MMRM|||Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596627|NCT02942004|2934367|Superiority||LS mean difference|-0.34|Standard Error of the Mean|0.213||0.1099|2-Sided|95.0|-0.77|0.08|||MMRM|||Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596628|NCT02942004|2934367|Superiority||LS mean difference|-0.38|Standard Error of the Mean|0.219||0.0819|2-Sided|95.0|-0.82|0.05|||MMRM|||Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596629|NCT02942004|2934367|Superiority||LS mean difference|-0.03|Standard Error of the Mean|0.21||0.8979|2-Sided|95.0|-0.44|0.39|||MMRM|||Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596630|NCT02942004|2934367|Superiority||LS mean difference|-0.36|Standard Error of the Mean|0.218||0.1048|2-Sided|95.0|-0.79|0.08|||MMRM|||Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596631|NCT02942004|2934367|Superiority||LS mean difference|0.01|Standard Error of the Mean|0.227||0.959|2-Sided|95.0|-0.44|0.46|||MMRM|||Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596632|NCT02942004|2934367|Superiority||LS mean difference|-0.45|Standard Error of the Mean|0.234||0.054|2-Sided|95.0|-0.92|0.01|||MMRM|||Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596633|NCT02942004|2934367|Superiority||LS mean difference|0.28|Standard Error of the Mean|0.232||0.2292|2-Sided|95.0|-0.18|0.74|||MMRM|||Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596634|NCT02942004|2934367|Superiority||LS mean difference|-0.2|Standard Error of the Mean|0.239||0.4007|2-Sided|95.0|-0.67|0.27|||MMRM|||Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596635|NCT02942004|2934367|Superiority||LS mean difference|-0.1|Standard Error of the Mean|0.228||0.661|2-Sided|95.0|-0.55|0.35|||MMRM|||Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596636|NCT02942004|2934367|Superiority||LS mean difference|-0.42|Standard Error of the Mean|0.234||0.0772|2-Sided|95.0|-0.88|0.05|||MMRM|||Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596637|NCT02942004|2934367|Superiority||LS mean difference|-0.14|Standard Error of the Mean|0.22||0.5196|2-Sided|95.0|-0.58|0.29|||MMRM|||Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596638|NCT02942004|2934367|Superiority||LS mean difference|-0.43|Standard Error of the Mean|0.226||0.0626|2-Sided|95.0|-0.87|0.02|||MMRM|||Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596639|NCT02942004|2934367|Superiority||LS mean difference|0.06|Standard Error of the Mean|0.185||0.7297|2-Sided|95.0|-0.3|0.43|||MMRM|||Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596640|NCT02942004|2934367|Superiority||LS mean difference|-0.08|Standard Error of the Mean|0.191||0.6809|2-Sided|95.0|-0.46|0.3|||MMRM|||Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596641|NCT02942004|2934367|Superiority||LS mean difference|-0.44|Standard Error of the Mean|0.244||0.0772|2-Sided|95.0|-0.92|0.05|||MMRM|||Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596642|NCT02942004|2934367|Superiority||LS mean difference|-0.66|Standard Error of the Mean|0.248||0.0089|2-Sided|95.0|-1.15|-0.17|||MMRM|||Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596643|NCT02942004|2934367|Superiority||LS mean difference|-0.28|Standard Error of the Mean|0.291||0.3448|2-Sided|95.0|-0.85|0.3|||MMRM|||Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596644|NCT02942004|2934367|Superiority||LS mean difference|-0.32|Standard Error of the Mean|0.304||0.2998|2-Sided|95.0|-0.92|0.29|||MMRM|||Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596645|NCT02942004|2934367|Superiority||LS mean difference|-0.11|Standard Error of the Mean|0.291||0.6964|2-Sided|95.0|-0.69|0.46|||MMRM|||Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596646|NCT02942004|2934367|Superiority||LS mean difference|-0.53|Standard Error of the Mean|0.301||0.0805|2-Sided|95.0|-1.13|0.07|||MMRM|||Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596647|NCT02942004|2934367|Superiority||LS mean difference|-0.06|Standard Error of the Mean|0.24||0.8152|2-Sided|95.0|-0.53|0.42|||MMRM|||Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596648|NCT02942004|2934367|Superiority||LS mean difference|-0.45|Standard Error of the Mean|0.246||0.0703|2-Sided|95.0|-0.94|0.04|||MMRM|||Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596649|NCT02942004|2934367|Superiority||LS mean difference|-0.23|Standard Error of the Mean|0.228||0.3213|2-Sided|95.0|-0.68|0.22|||MMRM|||Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596650|NCT02942004|2934367|Superiority||LS mean difference|-0.58|Standard Error of the Mean|0.234||0.0149|2-Sided|95.0|-1.04|-0.11|||MMRM|||Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596682|NCT02942004|2934370|Superiority||Odds Ratio (OR)|2.5||||0.0572|2-Sided|95.0|1.0|6.5|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.|
1596651|NCT02942004|2934367|Superiority||LS mean difference|-0.36|Standard Error of the Mean|0.238||0.1339|2-Sided|95.0|-0.83|0.11|||MMRM|||Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596652|NCT02942004|2934367|Superiority||LS mean difference|-0.71|Standard Error of the Mean|0.244||0.0044|2-Sided|95.0|-1.19|-0.23|||MMRM|||Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596653|NCT02942004|2934367|Superiority||LS mean difference|-0.26|Standard Error of the Mean|0.244||0.2903|2-Sided|95.0|-0.74|0.22|||MMRM|||Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596654|NCT02942004|2934367|Superiority||LS mean difference|-0.49|Standard Error of the Mean|0.251||0.0544|2-Sided|95.0|-0.99|0.01|||MMRM|||Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596655|NCT02942004|2934367|Superiority||LS mean difference|-0.02|Standard Error of the Mean|0.239||0.9286|2-Sided|95.0|-0.5|0.45|||MMRM|||Depressed Mood, Change Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596656|NCT02942004|2934367|Superiority||LS mean difference|-0.57|Standard Error of the Mean|0.247||0.0235|2-Sided|95.0|-1.06|-0.08|||MMRM|||Depressed Mood, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596657|NCT02942004|2934367|Superiority||LS mean difference|-0.07|Standard Error of the Mean|0.229||0.749|2-Sided|95.0|-0.53|0.38|||MMRM|||Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596658|NCT02942004|2934367|Superiority||LS mean difference|0.0|Standard Error of the Mean|0.236||0.9866|2-Sided|95.0|-0.47|0.46|||MMRM|||Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596659|NCT02942004|2934367|Superiority||LS mean difference|0.18|Standard Error of the Mean|0.24||0.4572|2-Sided|95.0|-0.3|0.65|||MMRM|||Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596660|NCT02942004|2934367|Superiority||LS mean difference|-0.17|Standard Error of the Mean|0.247||0.4941|2-Sided|95.0|-0.66|0.32|||MMRM|||Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596661|NCT02942004|2934367|Superiority||LS mean difference|0.09|Standard Error of the Mean|0.234||0.7042|2-Sided|95.0|-0.37|0.55|||MMRM|||Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596662|NCT02942004|2934367|Superiority||LS mean difference|-0.2|Standard Error of the Mean|0.24||0.3984|2-Sided|95.0|-0.68|0.27|||MMRM|||Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596663|NCT02942004|2934367|Superiority||LS mean difference|0.0|Standard Error of the Mean|0.232||0.9905|2-Sided|95.0|-0.46|0.46|||MMRM|||Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596664|NCT02942004|2934367|Superiority||LS mean difference|-0.17|Standard Error of the Mean|0.238||0.469|2-Sided|95.0|-0.64|0.3|||MMRM|||Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596665|NCT02942004|2934367|Superiority||LS mean difference|0.09|Standard Error of the Mean|0.185||0.6337|2-Sided|95.0|-0.28|0.46|||MMRM|||Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596666|NCT02942004|2934367|Superiority||LS mean difference|-0.01|Standard Error of the Mean|0.191||0.9681|2-Sided|95.0|-0.39|0.37|||MMRM|||Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596667|NCT02942004|2934368|Superiority||LS mean difference|-8.26|Standard Error of the Mean|4.464||0.0667|2-Sided|95.0|-17.1|0.58|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.|
1596668|NCT02942004|2934368|Superiority||LS mean difference|-11.68|Standard Error of the Mean|4.556||0.0116|2-Sided|95.0|-20.71|-2.66|||MMRM|||Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.|
1596669|NCT02942004|2934368|Superiority||LS mean difference|-2.24|Standard Error of the Mean|4.41||0.6124|2-Sided|95.0|-10.97|6.49|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.|
1596670|NCT02942004|2934368|Superiority||LS mean difference|-9.09|Standard Error of the Mean|4.51||0.0462|2-Sided|95.0|-18.02|-0.16|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.|
1596671|NCT02942004|2934368|Superiority||LS mean difference|-5.89|Standard Error of the Mean|4.188||0.1622|2-Sided|95.0|-14.19|2.41|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.|
1596672|NCT02942004|2934368|Superiority||LS mean difference|-12.07|Standard Error of the Mean|4.294||0.0058|2-Sided|95.0|-20.58|-3.56|||MMRM|||Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.|
1596673|NCT02942004|2934369|Superiority||Odds Ratio (OR)|1.6||||0.3507|2-Sided|95.0|0.6|4.2|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.|
1596674|NCT02942004|2934369|Superiority||Odds Ratio (OR)|2.3||||0.1052|2-Sided|95.0|0.8|6.0|||GEE method|||Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.|
1596675|NCT02942004|2934369|Superiority||Odds Ratio (OR)|0.6||||0.3401|2-Sided|95.0|0.2|1.7|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.|
1596676|NCT02942004|2934369|Superiority||Odds Ratio (OR)|1.2||||0.7749|2-Sided|95.0|0.4|3.1|||GEE method|||Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.|
1596812|NCT02938520|2934598|Other||Adjusted difference|0.1||||0.944|2-Sided|95.0|-2.3|2.5|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1597156|NCT02915835|2935775|Superiority|||||||0.38|||||||ANCOVA||||
1596684|NCT02942004|2934370|Superiority||Odds Ratio (OR)|5.4||||0.0052|2-Sided|95.0|1.7|17.4|||GEE method|||Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.|
1596685|NCT02942004|2934371|Superiority||LS mean difference|-3.51|Standard Error of the Mean|1.976||0.0786|2-Sided|95.0|-7.43|0.41|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596686|NCT02942004|2934371|Superiority||LS mean difference|-4.92|Standard Error of the Mean|2.045||0.0178|2-Sided|95.0|-8.98|-0.87|||MMRM|||Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596687|NCT02942004|2934371|Superiority||LS mean difference|-1.0|Standard Error of the Mean|2.08||0.631|2-Sided|95.0|-5.13|3.12|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596688|NCT02942004|2934371|Superiority||LS mean difference|-2.92|Standard Error of the Mean|2.139||0.1747|2-Sided|95.0|-7.16|1.32|||MMRM|||Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596689|NCT02942004|2934371|Superiority||LS mean difference|-1.58|Standard Error of the Mean|1.797||0.3799|2-Sided|95.0|-5.15|1.98|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596690|NCT02942004|2934371|Superiority||LS mean difference|-4.07|Standard Error of the Mean|1.837||0.0288|2-Sided|95.0|-7.71|-0.43|||MMRM|||Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596691|NCT02942004|2934371|Superiority||LS mean difference|-2.53|Standard Error of the Mean|1.694||0.1389|2-Sided|95.0|-5.88|0.83|||MMRM|||Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596692|NCT02942004|2934371|Superiority||LS mean difference|-5.02|Standard Error of the Mean|1.738||0.0046|2-Sided|95.0|-8.47|-1.58|||MMRM|||Change at hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596693|NCT02942004|2934371|Superiority||LS mean difference|-3.33|Standard Error of the Mean|1.69||0.0511|2-Sided|95.0|-6.68|0.02|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596694|NCT02942004|2934371|Superiority||LS mean difference|-4.49|Standard Error of the Mean|1.735||0.011|2-Sided|95.0|-7.93|-1.05|||MMRM|||Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596695|NCT02942004|2934371|Superiority||LS mean difference|-1.36|Standard Error of the Mean|1.572||0.3906|2-Sided|95.0|-4.47|1.76|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596696|NCT02942004|2934371|Superiority||LS mean difference|-5.12|Standard Error of the Mean|1.62||0.002|2-Sided|95.0|-8.33|-1.91|||MMRM|||Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1597015|NCT02926573|2935232|Superiority||Mean Difference (Final Values)|7.2|||||2-Sided|95.0|-4.6|18.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.||
1596697|NCT02942004|2934371|Superiority||LS mean difference|-2.32|Standard Error of the Mean|1.577||0.144|2-Sided|95.0|-5.45|0.8|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596698|NCT02942004|2934371|Superiority||LS mean difference|-4.28|Standard Error of the Mean|1.622||0.0094|2-Sided|95.0|-7.5|-1.07|||MMRM|||Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596699|NCT02942004|2934371|Superiority||LS mean difference|0.71|Standard Error of the Mean|1.395||0.6097|2-Sided|0.71|-2.05|3.48|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596700|NCT02942004|2934371|Superiority||LS mean difference|-1.25|Standard Error of the Mean|1.436||0.384|2-Sided|95.0|-4.1|1.59|||MMRM|||Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596701|NCT02942004|2934371|Superiority||LS mean difference|-0.36|Standard Error of the Mean|1.299||0.7801|2-Sided|95.0|-2.94|2.21|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596702|NCT02942004|2934371|Superiority||LS mean difference|-2.04|Standard Error of the Mean|1.336||0.1292|2-Sided|95.0|-4.69|0.61|||MMRM|||Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596703|NCT02942004|2934371|Superiority||LS mean difference|-0.3|Standard Error of the Mean|1.172||0.7968|2-Sided|95.0|-2.62|2.02|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596704|NCT02942004|2934371|Superiority||LS mean difference|-2.11|Standard Error of the Mean|1.208||0.0827|2-Sided|95.0|-4.51|0.28|||MMRM|||Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596705|NCT02942004|2934371|Superiority||LS mean difference|0.15|Standard Error of the Mean|0.917||0.8677|2-Sided|95.0|-1.66|1.97|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596706|NCT02942004|2934371|Superiority||LS mean difference|0.05|Standard Error of the Mean|0.951||0.9591|2-Sided|95.0|-1.83|1.93|||MMRM|||Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596707|NCT02942004|2934372|Superiority||LS mean difference|-3.79|Standard Error of the Mean|1.899||0.0481|2-Sided|95.0|-7.56|-0.03|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596708|NCT02942004|2934372|Superiority||LS mean difference|-5.63|Standard Error of the Mean|1.936||0.0044|2-Sided|95.0|-9.46|-1.79|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596709|NCT02942004|2934373|Superiority||LS mean difference|-3.68|Standard Error of the Mean|1.622||0.0252|2-Sided|95.0|-6.9|-0.47|||MMRM|||MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596813|NCT02938520|2934598|Other||Adjusted difference|1.8||||0.116|2-Sided|95.0|-0.4|3.9|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1596710|NCT02942004|2934373|Superiority||Least Square (LS) Mean Difference|-5.5|Standard Error of the Mean|1.664||0.0013|2-Sided|95.0|-8.8|-2.2|||MMRM|||Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.|
1596711|NCT02941640|2934377|Other|||||||1||||||Significant when P<0.05|Tukey post hoc test||||
1596712|NCT02941640|2934377|Other||||||<|0.0001||||||Significant when P<0.05.|Tukey post hoc test||||
1596713|NCT02941640|2934377|Other||||||<|0.0001|||||||Tukey post hoc test||||
1596714|NCT02941640|2934377|Other||||||<|0.0001||||||Significant when P<0.05.|Tukey post hoc test||||
1596715|NCT02941640|2934377|Other||||||<|0.0001||||||Significant when P<0.05|Tukey post hoc test||||
1596716|NCT02941640|2934377|Other||||||<|0.0001||||||Significant when P<0.05|Tukey post hoc test||||
1596717|NCT02941640|2934377|Other|Anova|||||<|0.0001||||||Significant when P<0.05.|ANOVA||||
1596718|NCT02941640|2934378|Other|||||||0.199||||||Significant when P<0.05.|Tukey post hoc test||||
1596719|NCT02941640|2934378|Other|||||||0.835||||||Significant when P<0.05.|Tukey post hoc test||||
1596720|NCT02941640|2934378|Other||||||<|0.272||||||Significant when P<0.05.|Tukey post hoc test||||
1596721|NCT02941640|2934378|Other||||||<|0.044||||||Significant when P<0.05|Tukey post hoc test||||
1596722|NCT02941640|2934378|Other|Tukey post hoc test|||||<|0.0001||||||Significant when P<0.05|Tukey post hoc test||||
1596723|NCT02941640|2934378|Other||||||<|0.001||||||Significant when P<0.05.|Tukey post hoc test|||Post hoc analysis was done by Tukey test.|
1596724|NCT02941640|2934378|Other|Anova|||||<|0.0001||||||Significant when P<0.05|ANOVA||||
1596725|NCT02940886|2934387|Superiority||Mean Difference (Final Values)|-0.31||||0.5703|2-Sided|95.0|-1.39|0.76|||Mixed model for repeated measures|||"Week 8~Change in fatigue symptoms score from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."|
1596726|NCT02940886|2934387|Superiority||Mean Difference (Final Values)|-0.39||||0.4646|2-Sided|95.0|-1.44|0.66|||Mixed model for repeated measures|||"Week 2~Change in fatigue symptoms score from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."|
1596727|NCT02940886|2934387|Superiority||Mean Difference (Final Values)|1.02||||0.0422|2-Sided|95.0|0.04|2.01|||Mixed model for repeated measures|||"Week 1~Change in fatigue symptoms score from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."|
1596728|NCT02940886|2934388|Superiority||Mean Difference (Final Values)|0.4||||0.8207|2-Sided|95.0|-2.7|3.4|||Mixed model for repeated measures|||"Week 8~Change in s-iron from baseline to week 8 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."|
1596729|NCT02940886|2934388|Superiority||Mean Difference (Final Values)|-0.8||||0.6027|2-Sided|95.0|-4.0|2.3|||Mixed model for repeated measures|||"Week 4~Change in s-iron from baseline to week 4 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."|
1596730|NCT02940886|2934388|Superiority||Mean Difference (Final Values)|5.0||||0.0375|2-Sided|95.0|0.3|9.8|||Mixed model for repeated measures|||"Week 2~Change in s-iron from baseline to week 2 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."|
1596731|NCT02940886|2934388|Superiority||Mean Difference (Final Values)|43.7|||<|0.0001|2-Sided|95.0|38.1|49.3|||Mixed model for repeated measures|||"Week 1~Change in s-iron from baseline to week 1 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, including 95% CIs and corresponding p-value."|
1596732|NCT02940886|2934389|Superiority||Mean Difference (Final Values)|0.9||||0.0569|2-Sided|95.0|0.0|1.8|||Mixed model for repeated measures|||"Week 8~Change in TSAT from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596733|NCT02940886|2934389|Superiority||Mean Difference (Final Values)|1.2||||0.0162|2-Sided|95.0|0.2|2.1|||Mixed model for repeated measures|||"Week 4~Change in TSAT from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596734|NCT02940886|2934389|Superiority||Mean Difference (Final Values)|2.4||||0.0001|2-Sided|95.0|1.2|3.6|||Mixed model for repeated measures|||"Week 2~Change in TSAT from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596735|NCT02940886|2934389|Superiority||Mean Difference (Final Values)|11.4|||<|0.0001|2-Sided|95.0|10.1|12.7|||Mixed model for repeated measures|||"Week 1~Change in TSAT from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596736|NCT02940886|2934390|Superiority||Mean Difference (Final Values)|-8.3||||0.0812|2-Sided|95.0|-17.7|1.0|||Mixed model for repeated measures|||"Week 8~Change in concentrations of s-ferritin from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596737|NCT02940886|2934390|Superiority||Mean Difference (Final Values)|-9.0||||0.115|2-Sided|95.0|-20.3|2.2|||Mixed model for repeated measures|||"Week 4~Change in concentrations of s-ferritin from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596738|NCT02940886|2934390|Superiority||Mean Difference (Final Values)|41.7|||<|0.0001|2-Sided|95.0|25.6|57.8|||Mixed model for repeated measures|||"Week 2~Change in concentrations of s-ferritin from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596739|NCT02940886|2934390|Superiority||Mean Difference (Final Values)|267.7|||<|0.0001|2-Sided|95.0|246.3|289.0|||Mixed model for repeated measures|||"Week 1~Change in concentrations of s-ferritin from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596740|NCT02940886|2934391|Superiority||Mean Difference (Final Values)|0.09||||0.1091|2-Sided|95.0|-0.02|0.2|||Mixed model for repeated measures|||"Week 4~Change in Hb concentration from baseline to week 4 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."|
1596741|NCT02940886|2934391|Superiority||Mean Difference (Final Values)|0.29|||<|0.0001|2-Sided|95.0|0.19|0.38|||Mixed model for repeated measures|||"Week 2~Change in Hb concentration from baseline to week 2 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."|
1596742|NCT02940886|2934391|Superiority||Mean Difference (Final Values)|0.26|||<|0.0001|2-Sided|95.0|0.19|0.34|||Mixed model for repeated measures|||"Week 1~Change in Hb concentration from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."|
1596743|NCT02940886|2934392|Superiority||Odds Ratio (OR)|4.52|||<|0.0001|2-Sided|95.0|3.58|5.71|||Regression, Logistic|||"Proportion of subject who achieved a s-ferritin level of ≥100 ng/mL AND a TSAT of 20-50% at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value."|
1596744|NCT02940886|2934393|Superiority||Odds Ratio (OR)|1.02||||0.8746|2-Sided|95.0|0.81|1.28|||Regression, Logistic|||"The proportion of subjects who achieved an increase in Hb concentration ≥2 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose was presented with 95% CI and corresponding p-value."|
1596745|NCT02940886|2934394|Superiority||Odds Ratio (OR)|1.14||||0.242|2-Sided|95.0|0.92|1.41|||Regression, Logistic|||The proportion of subjects who achieved a Hb level of >12 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects. The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.|
1596746|NCT02940886|2934395|Superiority|||||||0.088|||||||Log Rank|||Time to Hb response was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a 2-sided log-rank test.|
1596747|NCT02940886|2934396|Superiority||Odds Ratio (OR)|1.05||||0.7032|2-Sided|95.0|0.8|1.38|||Repeated measures logistic regressioin|||"Week 8~Hb increase of ≥2 g/dL from baseline to week 8.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."|
1596748|NCT02940886|2934396|Superiority||Odds Ratio (OR)|1.23||||0.1049|2-Sided|95.0|0.96|1.58|||Repeated measures logistic regressioin|||"Week 4~Hb increase of ≥2 g/dL from baseline to week 4.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."|
1596749|NCT02940886|2934396|Superiority||Odds Ratio (OR)|2.42|||<|0.0001|2-Sided|95.0|1.8|3.26|||Repeated measures logistic regressioin|||"Week 2~Hb increase of ≥2 g/dL from baseline to week 2.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."|
1596750|NCT02940886|2934396|Superiority||Odds Ratio (OR)|2.44|||<|0.0077|2-Sided|95.0|1.27|4.72|||Repeated measures logistic regressioin|||"Week 1~Hb increase of ≥2 g/dL from baseline to week 1.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."|
1597157|NCT02915835|2935776|Superiority|||||||0.95|||||||ANCOVA||||
1596756|NCT02940886|2934401|Non-Inferiority|Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL.|Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.13|0.13|||||Mixed Model for Repeated Measurement was used for testing and included the fixed categorical effects of treatment, week, treatment-by-week interaction, strata, and the continuous covariates of baseline Hb and baseline Hb-by-week interaction.|"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose treatment group and with N=500 subjects in the iron sucrose treatment group, assuming no difference between the treatment groups and assuming a common standard deviation (SD) of 1.5 g/dL, the power was 100% for demonstrating non-inferiority of the change in Hb from baseline to week 8, using a non-inferiority margin of -0.5 g/dL.~The significance level was set to 5%."|
1596757|NCT02940860|2934407|Superiority||Mean Difference (Final Values)|0.27||||0.586|2-Sided|95.0|-0.71|1.25|||Mixed model for repeated measures|||"Week 8~Change in fatigue symptoms score from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."|
1596758|NCT02940860|2934407|Superiority||Mean Difference (Final Values)|-0.17||||0.7132|2-Sided|95.0|-1.06|0.73|||Mixed model for repeated measures|||"Week 2~Change in fatigue symptoms score from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."|
1596759|NCT02940860|2934407|Superiority||Mean Difference (Final Values)|0.1||||0.8196|2-Sided|95.0|-0.73|0.92|||Mixed model for repeated measures|||"Week 1~Change in fatigue symptoms score from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline score and baseline score-by-week interaction as covariates."|
1596760|NCT02940860|2934408|Superiority||Mean Difference (Final Values)|-2.5||||0.1307|2-Sided|95.0|-5.8|0.8|||Mixed model for repeated measures|||"Week 8~Change in s-iron from baseline to week 8 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."|
1596761|NCT02940860|2934408|Superiority||Mean Difference (Final Values)|-0.2||||0.9046|2-Sided|95.0|-2.9|2.6|||Mixed model for repeated measures|||"Week 4~Change in s-iron from baseline to week 4 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."|
1596762|NCT02940860|2934408|Superiority||Mean Difference (Final Values)|1.9||||0.2229|2-Sided|95.0|-1.2|5.1|||Mixed model for repeated measures|||"Week 2~Change in s-iron from baseline to week 2 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."|
1596763|NCT02940860|2934408|Superiority||Mean Difference (Final Values)|26.5|||<|0.0001|2-Sided|95.0|20.4|32.7|||Mixed model for repeated measures|||"Week 1~Change in s-iron from baseline to week 1 was analysed using a Mixed Model for Repeated Measurement (MMRM) including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment-by week interaction effects are presented by week, including 95% CIs and corresponding p-value."|
1596764|NCT02940860|2934409|Superiority||Mean Difference (Final Values)|0.1||||0.8094|2-Sided|95.0|-0.9|1.2|||Mixed model for repeated measures|||"Week 8~Change in TSAT from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596765|NCT02940860|2934409|Superiority||Mean Difference (Final Values)|0.5||||0.2403|2-Sided|95.0|-0.4|1.5|||Mixed model for repeated measures|||"Week 4~Change in TSAT from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596766|NCT02940860|2934409|Superiority||Mean Difference (Final Values)|1.3||||0.0129|2-Sided|95.0|0.3|2.4|||Mixed model for repeated measures|||"Week 2~Change in TSAT from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596767|NCT02940860|2934409|Superiority||Mean Difference (Final Values)|8.8|||<|0.0001|2-Sided|95.0|6.9|10.7|||Mixed model for repeated measures|||"Week 1~Change in TSAT from baseline to week 1 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596768|NCT02940860|2934410|Superiority||Mean Difference (Final Values)|3.3||||0.7621|2-Sided|95.0|-18.1|24.7|||Mixed model for repeated measures|||"Week 8~Change in concentrations of s-ferritin from baseline to week 8 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596814|NCT02938520|2934599|Other||Adjusted difference|0.9||||0.472|2-Sided|95.0|-1.5|3.2|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1596769|NCT02940860|2934410|Superiority||Mean Difference (Final Values)|3.5||||0.7834|2-Sided|95.0|-21.2|28.1|||Mixed model for repeated measures|||"Week 4~Change in concentrations of s-ferritin from baseline to week 4 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596770|NCT02940860|2934410|Superiority||Mean Difference (Final Values)|95.8|||<|0.0001|2-Sided|95.0|67.9|123.7|||Mixed model for repeated measures|||"Week 2~Change in concentrations of s-ferritin from baseline to week 2 was analysed using MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596771|NCT02940860|2934410|Superiority||Mean Difference (Final Values)|309.2|||<|0.0001|2-Sided|95.0|280.7|337.8|||Mixed model for repeated measures|||"Week 1~Change in concentrations of s-ferritin from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates.~The estimated treatment differences based on the least square means of the treatment by-week interaction effects are presented by week, include 95% CIs and corresponding p-value."|
1596772|NCT02940860|2934411|Superiority||Mean Difference (Final Values)|0.15||||0.0208|2-Sided|95.0|0.02|0.28|||Mixed model for repeated measures|||"Week 4~Change in Hb concentration from baseline to week 4 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."|
1596773|NCT02940860|2934411|Superiority||Mean Difference (Final Values)|0.25|||<|0.0001|2-Sided|95.0|0.14|0.36|||Mixed model for repeated measures|||"Week 2~Change in Hb concentration from baseline to week 2 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."|
1596774|NCT02940860|2934411|Superiority||Mean Difference (Final Values)|0.22|||<|0.0001|2-Sided|95.0|0.12|0.31|||Mixed model for repeated measures|||"Week 1~Change in Hb concentration from baseline to week 1 was analysed using a MMRM including treatment, week, treatment-by-week interaction, and strata as factors and baseline value and baseline value-by-week interaction as covariates."|
1596775|NCT02940860|2934412|Superiority||Odds Ratio (OR)|1.82|||<|0.0001|2-Sided|95.0|1.38|2.4|||Regression, Logistic|||"Proportion of subject who achieved a s-ferritin level of ≥100 ng/mL AND a TSAT of 20-50% at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value."|
1596776|NCT02940860|2934413|Superiority||Odds Ratio (OR)|1.24||||0.1035|2-Sided|95.0|0.96|1.6|||Regression, Logistic|||"The proportion of subjects who achieved an increase in Hb concentration ≥2 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects.~The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose was presented with 95% CI and corresponding p-value."|
1596777|NCT02940860|2934414|Superiority||Odds Ratio (OR)|1.1||||0.5074|2-Sided|95.0|0.83|1.45|||Regression, Logistic|||The proportion of subjects who achieved a Hb level of >12 g/dL at any time from week 1 to week 8 was analysed using a logistic regression model with treatment and strata as fixed effects. The estimated treatment ratio of iron isomaltoside/ferric derisomaltose versus iron sucrose is presented with 95% CI and corresponding p-value.|
1596778|NCT02940860|2934415|Superiority|||||||0.0174|||||||Log Rank|||Time to Hb response was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a 2-sided log-rank test.|
1596779|NCT02940860|2934416|Superiority||Odds Ratio (OR)|1.01||||0.944|2-Sided|95.0|0.8|1.27|||Repeated measures logistic regressioin|||"Week 8~Hb increase of ≥1 g/dL from baseline to week 8.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."|
1596780|NCT02940860|2934416|Superiority||Odds Ratio (OR)|1.41||||0.0048|2-Sided|95.0|1.11|1.79|||Repeated measures logistic regressioin|||"Week 4~Hb increase of ≥1 g/dL from baseline to week 4.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."|
1596781|NCT02940860|2934416|Superiority||Odds Ratio (OR)|1.81|||<|0.0001|2-Sided|95.0|1.39|2.36|||Repeated measures logistic regressioin|||"Week 2~Hb increase of ≥1 g/dL from baseline to week 2.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."|
1596782|NCT02940860|2934416|Superiority||Odds Ratio (OR)|1.37|||<|0.0478|2-Sided|95.0|1.0|1.87|||Repeated measures logistic regressioin|||"Week 1~Hb increase of ≥1 g/dL from baseline to week 1.~Proportion of Hb responders to each week was analysed using a repeated measures logistic regression model with treatment, visit, strata, and treatment by visit interaction as fixed effects and baseline value as covariate."|
1596783|NCT02940860|2934418|Superiority|||||||0.0185|||||||Log Rank|||The time to first adjudicated and confirmed composite cardiovascular AEs was estimated using the Kaplan-Meier method and the hypothesis of no treatment difference was assessed by a log-rank test.|
1596784|NCT02940860|2934419|Superiority|||||||0.0248|||||||Fisher Exact|||Adjudicated and confirmed treatment-emergent composite cardiovascular AEs. Any treatment emergent composite cardiovascular AEs were included in the statistical evaluation. The overall incidence of adjudicated and confirmed composite cardiovascular AEs was tabulated and compared between the treatment groups by a Fisher’s exact test.|
1596785|NCT02940860|2934420|Non-Inferiority|Non-inferiority can be claimed if the upper bound of the 95% CI is below 1.5 % point.|Risk Difference (RD)|0.1|||||2-Sided|95.0|-0.57|0.48||||||Risk difference between iron isomaltoside/ferric derisomaltose and iron sucrose was assessed for the pooled FERWON-IDA and FERWON-NEPHRO trials (2008 subjects treated with iron isomaltoside/ferric derisomaltose and 1000 subjects treated with iron sucrose) with 95% Newcombe CI adjusted for stratum using the Cochran-Mantel-Haenszel method.|
1596788|NCT02940860|2934421|Non-Inferiority|Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL.|Mean Difference (Final Values)|0.08|||||2-Sided|95.0|-0.06|0.23|||||The Mixed Model for Repeated Measurement (MMRM) used for testing, included the fixed, categorical effects of treatment, week, treatment-by-week interaction, strata, and the continuous covariates of baseline Hb and baseline Hb-by-week interaction.|"Power:~With N=1000 subjects in the iron isomaltoside/ferric derisomaltose treatment group and with N=500 subjects in the iron sucrose treatment group, assuming no difference between the treatment groups and assuming a common standard deviation (SD) of 1.5 g/dL, the power was 100% for demonstrating non-inferiority of the change in Hb from baseline to week 8, using a non-inferiority margin of -0.5 g/dL.~The significance level was set to 5%."|
1596789|NCT02940626|2934433|Other|||||||0.547|||||||Wald Test on equality of proportions|||Subjects were analyzed for efficacy in the group to which they randomized. Sponsor defined outcomes were based on review of microbiology results from samples tested at the central lab. If sample was not sent to the central lab., determination was based on results from the local microbiology lab. In cases where both local & central lab results were available, concordance was confirmed for S. aureus. Therefore, the analysis used local microbiology data in order to utilize a more complete dataset.|
1596790|NCT02940574|2934441|Other|Linear mixed-effect analyses, exploring whether a single-dose of OT could reduce amygdala connectivity, revealed a tentative effect of ‘treatment’ (F(1,36)=2.00; p=.08 (one-sided))|||||<|0.08||||||Linear mixed-effect analyses, exploring whether a single-dose of OT could reduce amygdala connectivity, revealed a tentative effect of ‘treatment’ (F(1,36)=2.00; p=.08 (one-sided))|Mixed Models Analysis|(F(1,36)=2.00; p=.08 (one-sided))|||
1596791|NCT02940522|2934450|Other|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.
1596792|NCT02940522|2934451|Other|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.
1596793|NCT02940522|2934452|Other|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.
1596794|NCT02940522|2934453|Other|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.
1596795|NCT02940522|2934454|Other|Comparison of bioavailability data|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.
1596796|NCT02940522|2934455|Other|Comparison of bioavailability|||||||||||||||||The PK parameters were compared between treatments using an analysis of variance statistical model with treatment as the fixed effect, using the natural logarithms of the data. As the objective was to assess whether comparable exposure could be obtained using the higher SQ dose, the data were not normalized for dose before the statistical analysis.
1596797|NCT02938949|2934543|Superiority||||||>|0.2|||||||ANOVA||||
1596798|NCT02938949|2934544|Superiority||||||>|0.2|||||||ANOVA||||
1596799|NCT02938949|2934545|Superiority||||||<|0.01|||||||ANOVA||||
1596800|NCT02938520|2934592|Other||Adjusted difference|2.2||||0.236|2-Sided|95.0|-1.4|5.8|||ANCOVA||Treatment comparison at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1596801|NCT02938520|2934592|Other||Adjusted difference|2.7||||0.154|2-Sided|95.0|-1.0|6.4|||ANCOVA||Treatment comparison Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1596802|NCT02938520|2934592|Other||Adjusted difference|2.2||||0.232|2-Sided|95.0|-1.4|5.7|||ANCOVA||Treatment comparison at Week 8 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1596803|NCT02938520|2934594|Other||Difference|4.1|||<|0.001|2-Sided|95.0|2.8|5.5|||ANOVA||Treatment comparison of HIVTSQc-total treatment satisfaction score at Week 48 is presented, adjusted for Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1596804|NCT02938520|2934595|Other||Adjusted difference|0.7||||0.217|2-Sided|95.0|-0.4|1.9|||ANCOVA||Treatment comparison at Week 44 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1596805|NCT02938520|2934595|Other||Adjusted difference|2.2|||<|0.001|2-Sided|95.0|1.0|3.4|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1596806|NCT02938520|2934596|Other||Adjusted difference|-0.169||||0.689|2-Sided|95.0|-0.994|0.657|||ANCOVA||Treatment comparison of SF-12 PCS at Week 48 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1597016|NCT02926573|2935232|Superiority||Mean Difference (Final Values)|8.7|||||2-Sided|95.0|-2.9|20.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.||
1596815|NCT02938520|2934599|Other||Adjusted difference|1.2||||0.307|2-Sided|95.0|-1.1|3.6|||ANCOVA||Treatment comparison at Week 24 is presented, adjusted for Maintenance Baseline (Day 1) Score, Induction Baseline (Week -20) HIV-1 RNA (<100,000, >=100,000 c/mL), gender at birth, age (<50, >= 50 Years) and race (white, non-white).||
1596816|NCT02938520|2934601|Other||||||<|0.001||||||Week 41/48 was compared with the 1st visit (Week 5) based on Wilcoxon signed-rank test, respectively. p-values are derived for 'Acceptance' only and not adjusted for multiple testing.|Wilcoxon (Mann-Whitney)||||
1596817|NCT02938520|2934654|Non-Inferiority|Non-inferiority in the proportion of participants with HIV-1 RNA<50 c/mL at Week 48 (per FDA’s snapshot algorithm) can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in success rates between the two treatment arms (CAB – ABC/DTG/3TC) is more than -10%|Adjusted difference in proportion|0.4|||||2-Sided|95.0|-3.7|4.5|||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (<100,000 >=100,000 c/mL)||
1596818|NCT02938520|2934655|Non-Inferiority|Non-inferiority in the proportion of participants with virologic failure at Week 48 (per FDA’s snapshot algorithm for assessing HIV-1 RNA >=50 c/mL) can be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in failure rates between the two treatment arms (CAB – ABC/DTG/3TC) is less than 6%.|Adjusted difference in proportion|-0.4|||||2-Sided|95.0|-2.8|2.1|||||||Adjusted difference in proportion was based on Cochran-Mantel Haenszel stratified analysis adjusting for the following baseline stratification factors: sex at birth (Male, Female) and Induction Baseline (Week -20) HIV-1 RNA (<100,000 >=100,000 c/mL)
1596819|NCT02937870|2934673|Other||LS mean difference|0.86||||0.0352|2-Sided|95.0|0.06|1.66|||ANCOVA|ANCOVA with factors for subject (random effect), period & treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.||
1596820|NCT02937870|2934674|Other||LS mean difference|-0.79||||0.0488|2-Sided|95.0|-1.58|0.0|||ANCOVA|ANCOVA with factors for subject (random effect), period & treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.||
1596821|NCT02937870|2934675|Other||LS mean difference|0.07||||0.8566|2-Sided|95.0|-0.72|0.87|||ANCOVA|ANCOVA with factors for subject (random effect), period & treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.||
1596822|NCT02937870|2934676|Other||LS mean difference|-0.2||||0.8321|2-Sided|95.0|-0.98|0.59||p-values for treatment comparison of test adhesive 1 vs. no adhesive were adjusted using the Dunnett's method.|ANCOVA|ANCOVA with factors for subject (random effect), period & treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.||
1596823|NCT02937870|2934677|Other||Least square (LS) mean difference|0.66||||0.177|2-Sided|95.0|-0.14|1.47||p-values for treatment comparison of test adhesive 1 vs. no adhesive were adjusted using the Dunnett's method.|ANCOVA|ANCOVA with factors for subject (random effect), period & treatment, subject-level and period-level pre-treatment baseline bite force as covariate.|Difference is first-named treatment minus second-named treatment such that a positive difference favours the first named treatment.||
1596824|NCT02937766|2934678|Superiority||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.22||0.234|2-Sided|95.0|-0.2|0.7||The t-test tested the hypothesis of no treatment difference between treatment groups.|t-test, 2 sided||||
1596825|NCT02937766|2934679|Superiority||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.25||0.093|2-Sided|95.0|-0.1|0.9|||t-test, 2 sided|The t-test tested the hypothesis of no treatment difference between treatment groups.|||
1596826|NCT02937701|2934685|Other||Mean Difference|-0.2|||||2-Sided|90.0|-0.47|0.08||||||Week 50 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1596827|NCT02937701|2934685|Other||Mean Difference|0.0|||||2-Sided|90.0|-0.24|0.24||||||Week 50 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1596828|NCT02937701|2934685|Other||Mean Difference|-0.05|||||2-Sided|90.0|-0.34|0.25||||||Week 46 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1596829|NCT02937701|2934685|Other||Mean Difference|0.11|||||2-Sided|90.0|-0.14|0.37||||||Week 46 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1596830|NCT02937701|2934685|Other||Mean Difference|-0.08|||||2-Sided|90.0|-0.36|0.2||||||Week 38 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1596831|NCT02937701|2934685|Other||Mean Difference|0.06|||||2-Sided|90.0|-0.18|0.3||||||Week 38 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1597017|NCT02926573|2935232|Superiority||Mean Difference (Final Values)|7.4|||||2-Sided|95.0|-3.4|18.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.||
1596832|NCT02937701|2934685|Other||Mean Difference|-0.03|||||2-Sided|90.0|-0.3|0.24||||||Week 34 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1596833|NCT02937701|2934685|Other||Mean Difference|0.11|||||2-Sided|90.0|-0.12|0.35||||||Week 34 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1596834|NCT02937701|2934685|Other||Mean Difference|0.0|||||2-Sided|90.0|-0.27|0.28||||||Week 30 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1596835|NCT02937701|2934685|Other||Mean Difference|0.16|||||2-Sided|90.0|-0.08|0.4||||||Week 30 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1596836|NCT02937701|2934686|Other||Mean Difference|-0.01|||||2-Sided|90.0|-0.2|0.17||||||Week 22 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1596837|NCT02937701|2934686|Other||Mean Difference|-0.04|||||2-Sided|90.0|-0.21|0.14||||||Week 14 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1596838|NCT02937701|2934686|Other||Mean Difference|0.0|||||2-Sided|90.0|-0.17|0.16||||||Week 6 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1596839|NCT02937701|2934686|Other||Mean Difference|-0.07|||||2-Sided|90.0|-0.2|0.007||||||Week 2 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.|
1596840|NCT02937701|2934687|Other||Response Difference|12.06|||||2-Sided|90.0|1.74|22.04||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596841|NCT02937701|2934687|Other||Response Difference|1.95|||||2-Sided|90.0|-6.81|10.29||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596842|NCT02937701|2934687|Other||Response Difference|7.87|||||2-Sided|90.0|-2.13|17.68||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596843|NCT02937701|2934687|Other||Response Difference|-0.43|||||2-Sided|90.0|-8.98|7.66||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596844|NCT02937701|2934687|Other||Response Difference|3.39|||||2-Sided|90.0|-6.41|13.14||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596845|NCT02937701|2934687|Other||Response Difference|-0.5|||||2-Sided|90.0|-9.03|7.59||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596846|NCT02937701|2934687|Other||Response Difference|7.49|||||2-Sided|90.0|-2.39|17.22||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596847|NCT02937701|2934687|Other||Response Difference|1.5|||||2-Sided|90.0|-7.0|9.51||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596848|NCT02937701|2934687|Other||Response Difference|-0.08|||||2-Sided|90.0|-9.39|9.28||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596849|NCT02937701|2934687|Other||Response Difference|0.2|||||2-Sided|90.0|-8.12|8.02||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1597158|NCT02915835|2935777|Superiority|||||||0.25|||||||ANCOVA||||
1596850|NCT02937701|2934688|Other||Response Difference|4.58|||||2-Sided|90.0|-1.21|10.34||||||The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596851|NCT02937701|2934688|Other||Response Difference|5.46|||||2-Sided|90.0|-0.01|10.91||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596852|NCT02937701|2934688|Other||Response Difference|-2.43|||||2-Sided|90.0|-7.47|2.64||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596853|NCT02937701|2934688|Other||Response Difference|-2.5|||||2-Sided|90.0|-5.84|0.83||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596854|NCT02937701|2934689|Other||Response Difference|2.98|||||2-Sided|90.0|-7.51|13.37||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596855|NCT02937701|2934689|Other||Response Difference|-5.43|||||2-Sided|90.0|-14.39|3.71||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596856|NCT02937701|2934689|Other||Response Difference|6.14|||||2-Sided|90.0|-4.44|16.54||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596857|NCT02937701|2934689|Other||Response Difference|-1.04|||||2-Sided|90.0|-10.11|7.93||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596858|NCT02937701|2934689|Other||Response Difference|2.93|||||2-Sided|90.0|-7.62|13.39||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596859|NCT02937701|2934689|Other||Response Difference|0.56|||||2-Sided|90.0|-8.54|9.59||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596860|NCT02937701|2934689|Other||Response Difference|10.74|||||2-Sided|90.0|0.12|21.03||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596861|NCT02937701|2934689|Other||Response Difference|6.52|||||2-Sided|90.0|-2.62|15.48||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596862|NCT02937701|2934689|Other||Response Difference|3.24|||||2-Sided|90.0|-7.28|13.67||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596863|NCT02937701|2934689|Other||Response Difference|-1.33|||||2-Sided|90.0|-10.4|7.62||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596864|NCT02937701|2934690|Other||Response Difference|7.09|||||2-Sided|90.0|0.27|13.83||||||The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596865|NCT02937701|2934690|Other||Response Difference|2.3|||||2-Sided|90.0|-4.45|9.03||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596866|NCT02937701|2934690|Other||Response Difference|1.62|||||2-Sided|90.0|-4.71|7.94||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596867|NCT02937701|2934690|Other||Response Difference|4.41|||||2-Sided|90.0|-0.56|9.38||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596868|NCT02937701|2934691|Other||Response Difference|-1.49|||||2-Sided|90.0|-11.01|8.04||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1597018|NCT02926573|2935233|Superiority||Percent Difference|-2.0|||||2-Sided|95.0|-15.0|11.0|||||"The estimation parameter is based on those participants who answered they were very satisfied with overall pain control."||
1596869|NCT02937701|2934691|Other||Response Difference|-5.25|||||2-Sided|90.0|-13.24|3.29||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596870|NCT02937701|2934691|Other||Response Difference|1.12|||||2-Sided|90.0|-8.89|11.08||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596871|NCT02937701|2934691|Other||Response Difference|-3.74|||||2-Sided|90.0|-12.27|5.17||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596872|NCT02937701|2934691|Other||Response Difference|2.79|||||2-Sided|90.0|-6.86|12.34||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596873|NCT02937701|2934691|Other||Response Difference|0.82|||||2-Sided|90.0|-7.34|9.4||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596874|NCT02937701|2934691|Other||Response Difference|4.06|||||2-Sided|90.0|-5.4|13.4||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596875|NCT02937701|2934691|Other||Response Difference|3.31|||||2-Sided|90.0|-4.61|11.7||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596876|NCT02937701|2934691|Other||Response Difference|8.5|||||2-Sided|90.0|-1.18|17.97||||||The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596877|NCT02937701|2934691|Other||Response Difference|3.05|||||2-Sided|90.0|-5.26|11.73||||||The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596878|NCT02937701|2934692|Other||Response Difference|9.37|||||2-Sided|90.0|-0.51|12.87||||||The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596879|NCT02937701|2934692|Other||Response Difference|4.96|||||2-Sided|90.0|-1.8|11.64||||||The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596880|NCT02937701|2934692|Other||Response Difference|8.03|||||2-Sided|90.0|1.15|14.81||||||The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).|
1596881|NCT02937701|2934693|Equivalence|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|7.184|||||2-Sided|90.0|0.748|13.62|||||The ACR core set includes tender joint count, swollen joint count, subject’s global health assessment, investigator’s global health assessment, subject’s assessment of disease related pain, HAQ-DI, and CRP.|A post-hoc analysis was conducted to adjust for the impact of random imbalance in baseline demographic and disease characteristics between the 2 treatment groups. The MH estimate of RD and corresponding CIs were estimated using a nonparametric analysis of covariance method with stratification factors geographic region and prior biologic use, and adjustment for baseline covariates (ACR core set, age, use of oral corticosteroid, use of NSAID, body mass index categories, and methotrexate dose).|
1596882|NCT02937701|2934693|Equivalence|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|9.3|||||2-Sided|90.0|2.67|15.92|||||Response Difference is based on a generalized linear model with actual stratification variables (geographic region and prior biologic use for RA) as covariates in the model.|A sensitivity analysis with the RD estimate and CIs for RD of ACR20 estimated using a generalized linear model with geographic region and prior biologic use for RA as covariates was also conducted.|
1596883|NCT02937701|2934693|Equivalence|Clinical equivalence for the primary endpoint was to be evaluated sequentially by first comparing the 2-sided 90% CI for RD of ACR20 at week 22 between ABP 710 and infliximab with an equivalence margin of (-15%, 15%). If the first test was successful, RD of ACR20 at week 22 was to be further evaluated by comparing the 2-sided 90% CI between ABP 710 and infliximab with an equivalence margin of (-12%, 15%).|Response Difference|9.37|||||2-Sided|90.0|2.67|15.96||||||For the primary analysis of ACR20, the response difference (RD) was estimated by the Mantel-Haenszel (MH) estimate and the 90% confidence intervals (CIs) of RD were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use for RA).|
1596884|NCT02937636|2934697|Other||Least square (LS) mean difference|-0.09|||<|0.0001|2-Sided|95.0|-0.12|-0.07|||ANCOVA|From ANCOVA with treatment, gender, smoking status and baseline MGI stratification as factors and baseline as covariate.|Difference is the first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1596885|NCT02937623|2934701|Other||Least square mean difference|-0.44|||<|0.0001||95.0|-0.591|-0.297|||ANCOVA|ANCOVA model: change from baseline in Schiff sensitivity score as response and treatment as factors and baseline Schiff sensitivity score as covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.||
1596886|NCT02937584|2934702|Other||Geometric mean ratio to baseline|0.938||||0.2699|2-Sided|95.0|0.833|1.056|||t-test, 2 sided|Within-group comparison to baseline using paired test|||
1596887|NCT02937584|2934702|Other||Geometric mean ratio to baseline|0.978||||0.6176|2-Sided|95.0|0.891|1.073|||t-test, 2 sided|Within-group comparison to baseline using paired test|||
1596888|NCT02937584|2934703|Other||Mean Change from Baseline|0.151||||0.0375|2-Sided|95.0|0.01|0.292|||t-test, 2 sided|Within-group comparison to baseline using paired test|||
1596889|NCT02937584|2934703|Other||Mean Change from Baseline|0.065||||0.1582|2-Sided|95.0|-0.028|0.158|||t-test, 2 sided|Within-group comparison to baseline using paired test|||
1596890|NCT02937584|2934704|Other||Geometric mean ratio to baseline|0.55||||0.0003|2-Sided|95.0|0.41|0.72|||t-test, 2 sided|Within-group comparison to baseline using paired test|||
1596891|NCT02937584|2934704|Other||Geometric mean ratio to baseline|0.76||||0.0304|2-Sided|95.0|0.59|0.97|||t-test, 2 sided|Within-group comparison to baseline using paired test|||
1596892|NCT02937584|2934705|Other||Geometric mean ratio to baseline|1.21|||<|0.0001|2-Sided|95.0|1.12|1.31|||t-test, 2 sided|Within-group comparison to baseline using paired test|||
1596893|NCT02937584|2934705|Other||Geometric mean ratio to baseline|1.12|||<|0.0283|2-Sided|95.0|1.01|1.24|||t-test, 2 sided|Within-group comparison to baseline using paired test|||
1596894|NCT02937584|2934706|Other||Geometric mean ratio to baseline|0.56|||<|0.0001|2-Sided|95.0|0.44|0.71||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test|||
1596895|NCT02937584|2934706|Other||Geometric mean ratio to baseline|0.75|||<|0.0219|2-Sided|95.0|0.59|0.95||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test|||
1596896|NCT02937584|2934707|Other||Geometric mean ratio to baseline|1.23|||<|0.0001|2-Sided|95.0|1.14|1.33||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test|||
1596897|NCT02937584|2934707|Other||Geometric mean ratio to baseline|1.11|||<|0.0187|2-Sided|95.0|1.02|1.22||Statistical significance assessed using Hochberg's procedure applied across primary endpoints within each treatment|t-test, 2 sided|Within-group comparison to baseline using paired test|||
1596898|NCT02935673|2934776|Superiority||AUC(1-7) difference vs (pooled) placebo|-0.36|||||2-Sided|95.0|-1.33|0.62|||||||Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.
1596899|NCT02935673|2934776|Superiority||AUC(1-7) difference vs (pooled) placebo|-0.32|||||2-Sided|95.0|-0.89|0.24|||||||Mixed model for repeated measures, using all available viral load data of baseline and up to and including Day 7, taking missing data into account under the missing at random assumption.
1596900|NCT02935062|2934807|Superiority|||||||0.011|||||||t-test, 1 sided||||
1596901|NCT02935062|2934808|Superiority|||||||0.001|||||||t-test, 1 sided||||
1596902|NCT02935036|2934809|Superiority||Percent difference|2.4||||0.692|2-Sided||||||Cochran-Mantel-Haenszel||||
1596903|NCT02935036|2934810|Superiority||LS Mean Difference|2.75||||0.2912|2-Sided||||||ANOVA||||
1596904|NCT02935036|2934811|Superiority||LS Mean Difference|1.33||||0.5947|2-Sided||||||ANOVA||||
1596905|NCT02934347|2934817|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1596906|NCT02934347|2934818|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1596907|NCT02934347|2934819|Superiority or Other||||||<|0.01|||||||Chi-squared|df=3|||
1596908|NCT02934347|2934820|Superiority or Other||||||>|0.05||||||Grades analysed were 1, 2 and then 3 and 4 combined because of low frequencies in the latter two grades|Chi-squared, Corrected|Chi-squared for trend||Null hypothesis: no difference in frequency of grade of glottic view between the supine and back-up positions|
1596909|NCT02933879|2934869|Superiority|||||||0.2467|||||||Z-test, 2 sided||||
1596910|NCT02933879|2934872|Superiority|||||||1|||||||Z-test, 2 sided||||
1596911|NCT02933879|2934874|Superiority|||||||1|||||||Z-test, 2 sided||||
1596912|NCT02933879|2934876|Superiority|||||||0.2106|||||||Z-test, 2 sided||||
1596913|NCT02933879|2934876|Superiority|||||||0.0404|||||||Z-test, 2 sided||||
1596914|NCT02933879|2934878|Superiority|||||||0.4615|||||||Z-test, 2 sided||||
1596915|NCT02933866|2934879|Superiority|||||||0.2961|||||||Cochran-Mantel-Haenszel||||
1596916|NCT02933476|2934882|Superiority||||||<|0.001|||||||ANOVA||||
1596917|NCT02933476|2934883|Superiority|||||||0.008|||||||ANOVA||||
1596918|NCT02933476|2934884|Superiority||||||>|0.05|||||||ANOVA|||We compared off therapy UPDRS III scores at baseline to one and four weeks after stimulation.|
1596919|NCT02933034|2934909|Other|||||||0.001|||||||t-test, 2 sided|||Comparison of infarct size using MEMRI versus DEMRI scan|
1596920|NCT02932943|2934910|Superiority||Least Squares Mean Difference|-0.4||||0.6108|2-Sided|95.0|-2.05|1.21|||Mixed Model Repeated Measures (MMRM)||||
1596921|NCT02932943|2934911|Superiority||Least Squares Mean Difference|0.2||||0.8131|2-Sided|95.0|-1.53|1.95|||Mixed Model Repeated Measures (MMRM)||||
1596922|NCT02932943|2934912|Superiority||Least Squares Mean Difference|-0.4||||0.559|2-Sided|95.0|-1.61|0.87|||Mixed Model Repeated Measures (MMRM)||||
1596923|NCT02932943|2934913|Superiority||Least Squares Mean Difference|0.3||||0.6482|2-Sided|95.0|-1.07|1.72|||Mixed Model Repeated Measures (MMRM)||||
1597019|NCT02926573|2935235|Superiority||Percent Difference|9.2|||||2-Sided|95.0|-3.0|21.0|||||||
1596924|NCT02932904|2934914|Superiority||LS Mean Difference|3.06|Standard Error of the Mean|1.072||0.005|2-Sided|95.0|0.95|5.17||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596925|NCT02932904|2934914|Superiority||LS Mean Difference|4.31|Standard Error of the Mean|1.078|<|0.001|2-Sided|95.0|2.19|6.43||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596926|NCT02932904|2934915|Superiority||LS Mean Difference|1.63|Standard Error of the Mean|1.068||0.129|2-Sided|95.0|-0.47|3.73||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596927|NCT02932904|2934915|Superiority||LS Mean Difference|3.38|Standard Error of the Mean|1.082||0.002|2-Sided|95.0|1.25|5.51||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596928|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|4.19||||0.046|2-Sided|95.0|1.027|17.063|||Regression, Logistic|||Week 5|
1596929|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.98||||0.371|2-Sided|95.0|0.442|8.902|||Regression, Logistic|||Week 5|
1596930|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|3.64||||0.073|2-Sided|95.0|0.888|14.911|||Regression, Logistic|||Week 5|
1596931|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.15||||0.79|2-Sided|95.0|0.41|3.233|||Regression, Logistic|||Week 5|
1596932|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using rate of subjects that shifted from normal at baseline to abnormal after baseline as response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.55||||0.317|2-Sided|95.0|0.166|1.789|||Regression, Logistic|||Week 5|
1596933|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.23||||0.24|2-Sided|95.0|0.585|8.472|||Regression, Logistic|||Week 4|
1596934|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.15||||0.852|2-Sided|95.0|0.266|4.961|||Regression, Logistic|||Week 4|
1596935|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.71||||0.133|2-Sided|95.0|0.739|9.917|||Regression, Logistic|||Week 4|
1596936|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.82||||0.729|2-Sided|95.0|0.273|2.476|||Regression, Logistic|||Week 4|
1596937|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.42||||0.187|2-Sided|95.0|0.119|1.514|||Regression, Logistic|||Week 4|
1596938|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.0||||0.329|2-Sided|95.0|0.497|8.037|||Regression, Logistic|||Week 3|
1596939|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.88||||0.871|2-Sided|95.0|0.181|4.261|||Regression, Logistic|||Week 3|
1596940|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|2.43||||0.194|2-Sided|95.0|0.636|9.317|||Regression, Logistic|||Week 3|
1596941|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.82||||0.744|2-Sided|95.0|0.252|2.679|||Regression, Logistic|||Week 3|
1596942|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.36||||0.16|2-Sided|95.0|0.087|1.497|||Regression, Logistic|||Week 3|
1596943|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.3||||0.154|2-Sided|95.0|0.059|1.561|||Regression, Logistic|||Week 2|
1596944|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.44||||0.256|2-Sided|95.0|0.107|1.814|||Regression, Logistic|||Week 2|
1596945|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.2||||0.758|2-Sided|95.0|0.383|3.731|||Regression, Logistic|||Week 2|
1596946|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.25||||0.098|2-Sided|95.0|0.05|1.287|||Regression, Logistic|||Week 2|
1596947|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.37||||0.164|2-Sided|95.0|0.09|1.507|||Regression, Logistic|||Week 2|
1596948|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.87||||0.913|2-Sided|95.0|0.066|11.303|||Regression, Logistic|||Week 1|
1596949|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.65||||0.732|2-Sided|95.0|0.053|7.861|||Regression, Logistic|||Week 1|
1596950|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|1.47||||0.72|2-Sided|95.0|0.181|11.912|||Regression, Logistic|||Week 1|
1596951|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.59||||0.677|2-Sided|95.0|0.049|7.051|||Regression, Logistic|||Week 1|
1596952|NCT02932904|2934918|Superiority|Odds ratio, 95% confidence intervals and p-values are from logistic regression model using the rate of subjects that shifted from normal at baseline to abnormal after baseline as the response and explanatory variables for treatment, baseline CSFQ-14 total score, and gender.|Odds Ratio (OR)|0.44||||0.515|2-Sided|95.0|0.037|5.201|||Regression, Logistic|||Week 1|
1596953|NCT02932904|2934919|Superiority||LS Mean Difference|-1.72|Standard Error of the Mean|1.0||0.087|2-Sided|95.0|-3.68|0.25|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596954|NCT02932904|2934919|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|1.018||0.977|2-Sided|95.0|-2.03|1.97|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596955|NCT02932904|2934919|Superiority||LS Mean Difference|-1.82|Standard Error of the Mean|0.907||0.046|2-Sided|95.0|-3.6|-0.03|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596956|NCT02932904|2934919|Superiority||LS Mean Difference|-0.58|Standard Error of the Mean|0.923||0.532|2-Sided|95.0|-2.39|1.24|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596957|NCT02932904|2934919|Superiority||LS Mean Difference|-1.44|Standard Error of the Mean|0.871||0.098|2-Sided|95.0|-3.16|0.27|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596958|NCT02932904|2934919|Superiority||LS Mean Difference|0.15|Standard Error of the Mean|0.886||0.87|2-Sided|95.0|-1.6|1.89|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596959|NCT02932904|2934919|Superiority||LS Mean Difference|-0.44|Standard Error of the Mean|0.814||0.592|2-Sided|95.0|-2.04|1.17|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1597020|NCT02926573|2935236|Superiority||Median Difference (Final Values)|0.26|||||2-Sided|95.0|-0.27|0.94|||||||
1596960|NCT02932904|2934919|Superiority||LS Mean Difference|-0.06|Standard Error of the Mean|0.828||0.938|2-Sided|95.0|-1.69|1.56|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596961|NCT02932904|2934919|Superiority||LS Mean Difference|-0.33|Standard Error of the Mean|0.6||0.581|2-Sided|95.0|-1.51|0.85|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596962|NCT02932904|2934919|Superiority||LS Mean Difference|-0.5|Standard Error of the Mean|0.612||0.419|2-Sided|95.0|-1.7|0.71|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596963|NCT02932904|2934920|Superiority||LS Mean Difference|-2.77|Standard Error of the Mean|1.024||0.007|2-Sided|95.0|-4.78|-0.75|||ANCOVA with LOCF|||Week 5, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596964|NCT02932904|2934920|Superiority||LS Mean Difference|-2.49|Standard Error of the Mean|0.929||0.008|2-Sided|95.0|-4.32|-0.66|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596965|NCT02932904|2934920|Superiority||LS Mean Difference|-1.85|Standard Error of the Mean|0.892||0.039|2-Sided|95.0|-3.61|-0.1|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596966|NCT02932904|2934920|Superiority||LS Mean Difference|-1.29|Standard Error of the Mean|0.834||0.123|2-Sided|95.0|-2.93|0.35|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596967|NCT02932904|2934920|Superiority||LS Mean Difference|-1.63|Standard Error of the Mean|0.616||0.009|2-Sided|95.0|-2.84|-0.41|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596968|NCT02932904|2934921|Superiority||LS Mean Difference|0.68|Standard Error of the Mean|0.923||0.465|2-Sided|95.0|-1.14|2.49|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596969|NCT02932904|2934921|Superiority||LS Mean Difference|1.91|Standard Error of the Mean|0.943||0.043|2-Sided|95.0|0.06|3.77|||ANCOVA with LOCF|||Week 4, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596970|NCT02932904|2934921|Superiority||LS Mean Difference|0.41|Standard Error of the Mean|0.886||0.645|2-Sided|95.0|-1.33|2.15|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596971|NCT02932904|2934921|Superiority||LS Mean Difference|2.0|Standard Error of the Mean|0.906||0.028|2-Sided|95.0|0.22|3.78|||ANCOVA with LOCF|||Week 3, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596972|NCT02932904|2934921|Superiority||LS Mean Difference|0.85|Standard Error of the Mean|0.828||0.303|2-Sided|95.0|-0.78|2.48|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596973|NCT02932904|2934921|Superiority||LS Mean Difference|1.22|Standard Error of the Mean|0.846||0.149|2-Sided|95.0|-0.44|2.89|||ANCOVA with LOCF|||Week 2, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596974|NCT02932904|2934921|Superiority||LS Mean Difference|1.29|Standard Error of the Mean|0.612||0.035|2-Sided|95.0|0.09|2.5|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596975|NCT02932904|2934921|Superiority||LS Mean Difference|1.13|Standard Error of the Mean|0.627||0.072|2-Sided|95.0|-0.1|2.37|||ANCOVA with LOCF|||Week 1, ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596976|NCT02932904|2934922|Superiority||LS Mean Difference|1.05|Standard Error of the Mean|1.017||0.303|2-Sided|95.0|-0.95|3.05||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA model with the LOCF method was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596977|NCT02932904|2934922|Superiority||Least square (LS) Mean Difference|2.74|Standard Error of the Mean|1.04||0.009|2-Sided|95.0|0.69|4.78||The comparisons were between each vortioxetine dose (10 or 20 mg) and paroxetine, and the Holm-Bonferroni method was used to adjust for multiplicity and control the familywise type I error rate at a significance level of 0.05.|ANCOVA with LOCF|||ANCOVA with last observation carried forward (LOCF) model was used for p-value with treatment, pooled center, and gender as fixed factors and with baseline CSFQ-14 total score as a covariate.|
1596978|NCT02932462|2934928|Superiority|||||||0.7652|||||||Cochran-Mantel-Haenszel||||
1596979|NCT02932462|2934929|Superiority|||||||0.8096|||||||Cochran-Mantel-Haenszel||||
1596980|NCT02932462|2934930|Superiority|||||||0.4557|||||||Cochran-Mantel-Haenszel||||
1596981|NCT02932306|2934933|Superiority||||||<|0.001||||||Threshold for significance at 0.05.|Regression, Logistic|||Analysis was performed using a logistic regression test (using Firth’s Penalized Likelihood) with factors of treatment group and analysis center.|
1596982|NCT02932306|2934934|Superiority||||||<|0.001||||||Threshold for significance at 0.05.|ANCOVA|||Analysis was performed using ANCOVA with factors of treatment group and analysis center and the respective baseline lesion count as a covariate.|
1596987|NCT02930837|2934958|Superiority||Percentage of patients|63.3|||<|0.0001|2-Sided|95.0|54.42|71.42|||One-sample test||Percentage of patients with Favourable outcome|A null hypothesis of p ≤40% versus the alternative hypothesis of p >40% was tested using a one sample test at two-sided significance level of 0.05, where p denoted the response rate in Chinese patients who were treated within 3-4.5 h after stroke onset.|
1596988|NCT02930174|2935058|Equivalence|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|Standard Deviation|2.0||0.136|2-Sided||||||ANOVA||||
1596989|NCT02930174|2935059|Equivalence|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|Standard Deviation|2.0||0.204|2-Sided||||||ANOVA||||
1596990|NCT02930174|2935060|Equivalence|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|Standard Deviation|2.0||0.283|2-Sided||||||ANOVA||||
1596991|NCT02930174|2935061|Equivalence|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|Standard Deviation|2.0||0.184|2-Sided||||||ANOVA||||
1596992|NCT02930174|2935062|Equivalence|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|Standard Deviation|2.0||0.342|2-Sided||||||ANOVA||||
1596993|NCT02930174|2935063|Equivalence|Two devices were tested while measuring the differences in lung impedance under multiple pressure settings to determine whether the devices perform in an equivalent fashion. We looked at the mean differences between the 2 devices across the 4 pressure settings.|Mean Difference (Final Values)|0.1|Standard Deviation|2.0||0.26|2-Sided||||||ANOVA||||
1596994|NCT02928770|2935145|Other|||||||0.0559|||||||t-test, 2 sided|Comparison between baseline and experimental (Nastent) conditions|||
1596995|NCT02928380|2935155|Other||Least square (LS) mean difference|-0.02||||0.0987|2-Sided|95.0|-0.05|0.0|||ANOVA|ANOVA Model with weight of the peanut particle (food occlusion) as response variable, treatment and period as fixed effect.|Difference is first named treatment minus second named treatment is such that a negative difference favors the first named treatment.|H0: The mean mass of food particles retrieved from using a marketed denture adhesive with a flat ribbon nozzle is no different from using no adhesive H01: The mean mass of food particles retrieved from using a marketed denture adhesive with a flat ribbon nozzle is different from using no adhesive.|
1596996|NCT02927171|2935225|Other|||||||0.17|||||||t-test, 1 sided||||
1596997|NCT02926573|2935230|Superiority||Mean Difference (Final Values)|16.7|||||2-Sided|95.0|0.0|33.4|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.||
1596998|NCT02926573|2935230|Superiority||Mean Difference (Final Values)|15.7|||||2-Sided|95.0|-0.4|31.7|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.||
1596999|NCT02926573|2935230|Superiority||Mean Difference (Final Values)|8.0|||||2-Sided|95.0|-6.4|22.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.||
1597000|NCT02926573|2935230|Superiority||Mean Difference (Final Values)|7.0|||||2-Sided|95.0|-6.6|20.7|||||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.
1597001|NCT02926573|2935230|Superiority||Mean Difference (Final Values)|10.9|||||2-Sided|95.0|-2.4|24.2|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.||
1597002|NCT02926573|2935230|Superiority||Mean Difference (Final Values)|5.3|||||2-Sided|95.0|-8.6|19.2|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.||
1597003|NCT02926573|2935230|Superiority||Mean Difference (Final Values)|-1.4|||||2-Sided|95.0|-14.7|11.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.||
1597004|NCT02926573|2935231|Superiority||Mean Difference (Final Values)|11.6|||||2-Sided|95.0|-2.8|26.0|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.||
1597005|NCT02926573|2935231|Superiority||Mean Difference (Final Values)|14.9|||||2-Sided|95.0|-0.1|29.9|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.||
1597006|NCT02926573|2935231|Superiority||Mean Difference (Final Values)|11.2|||||2-Sided|95.0|-1.4|23.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 10AM.||
1597007|NCT02926573|2935231|Superiority||Mean Difference (Final Values)|5.3|||||2-Sided|95.0|-7.3|17.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7AM.||
1597008|NCT02926573|2935231|Superiority||Mean Difference (Final Values)|6.3|||||2-Sided|95.0|-6.1|18.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7PM.||
1597009|NCT02926573|2935231|Superiority||Mean Difference (Final Values)|9.1|||||2-Sided|95.0|-3.4|21.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 10AM.||
1597010|NCT02926573|2935231|Superiority||Mean Difference (Final Values)|10.7|||||2-Sided|95.0|-0.9|22.3|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 1 7AM.||
1597011|NCT02926573|2935232|Superiority||Mean Difference (Final Values)|10.1|||||2-Sided|95.0|-3.5|23.8|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 3 7AM.||
1597012|NCT02926573|2935232|Superiority||Mean Difference (Final Values)|8.0|||||2-Sided|95.0|-5.6|21.6|||||This statistical analysis is for the mean difference between the 2 arms at Post-Operative Day 2 7PM.||
1597103|NCT02918071|2935675|Other||Percentage|97.4|||||2-Sided|95.0|92.69|99.47|||||Percentage of patients returned functional AI administered at home (Week 12)||
1597021|NCT02924883|2935281|Superiority||Hazard Ratio (HR)|1.26||||0.6099||95.0|0.52|3.03|||Log Rank|Stratified Cox proportional hazards model was stratified by world region (Western Europe, U.S., Rest of World) and PD-L1 status (IC 0, IC 1/2/3).|||
1597022|NCT02924883|2935285|Superiority||Hazard Ratio (HR)|0.82||||0.3332||95.0|0.55|1.23|||Log Rank|The 2-sided log-rank test, was stratified by world region (Western Europe vs U.S. vs Rest of World) and PD-L1 status (IC 0 vs IC 1/2/3).|||
1597023|NCT02924688|2935288|Other||Least Squares Mean Difference|0.2|Standard Error of the Mean|0.61||0.768|2-Sided|95.0|-1.0|1.4||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||||
1597024|NCT02924688|2935288|Other||Least Squares Mean Difference|-0.6|Standard Error of the Mean|0.61||0.349|2-Sided|95.0|-1.8|0.6||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||||
1597025|NCT02924688|2935288|Other||Least Squares Mean Difference|0.1|Standard Error of the Mean|0.61||0.839|2-Sided|95.0|-1.1|1.3||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||||
1597026|NCT02924688|2935288|Other||Least Squares Mean Difference|1.3|Standard Error of the Mean|0.61||0.034|2-Sided|95.0|0.1|2.5||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||||
1597027|NCT02924688|2935289|Other||Least Squares Mean Difference|0.4|Standard Error of the Mean|0.55||0.447|2-Sided|95.0|-0.7|1.5||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP||
1597028|NCT02924688|2935289|Other||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.56||0.806|2-Sided|95.0|-1.2|1.0||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP||
1597029|NCT02924688|2935289|Other||Least Squares Mean Difference|0.8|Standard Error of the Mean|0.56||0.142|2-Sided|95.0|-0.3|1.9||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP||
1597030|NCT02924688|2935289|Other||Least Squares Mean Difference|-0.4|Standard Error of the Mean|0.56||0.482|2-Sided|95.0|-1.5|0.7||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for DBP||
1597031|NCT02924688|2935289|Other||Least Squares Mean Difference|0.7|Standard Error of the Mean|0.74||0.349|2-Sided|95.0|-0.8|2.2||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP||
1597032|NCT02924688|2935289|Other||Least Squares Mean Difference|0.6|Standard Error of the Mean|0.75||0.426|2-Sided|95.0|-0.9|2.1||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP||
1597033|NCT02924688|2935289|Other||Least Squares Mean Difference|-0.6|Standard Error of the Mean|0.74||0.436|2-Sided|95.0|-2.0|0.9||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP||
1597034|NCT02924688|2935289|Other||Least Squares Mean Difference|-1.0|Standard Error of the Mean|0.75||0.172|2-Sided|95.0|-2.5|0.4||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||Comparison for SBP||
1597035|NCT02924688|2935292|Other||Least Squares Mean Difference|-0.42|Standard Error of the Mean|0.184||0.023|2-Sided|95.0|-0.78|-0.06||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and 4-weekly period, interaction terms for Baseline value by 4-weekly period and treatment by 4-weekly period.|Mixed Model Repeated Measures||||
1597036|NCT02924688|2935292|Other||Least Squares Mean Difference|-0.13|Standard Error of the Mean|0.185||0.479|2-Sided|95.0|-0.49|0.23||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and 4-weekly period, interaction terms for Baseline value by 4-weekly period and treatment by 4-weekly period.|Mixed Model Repeated Measures||||
1597037|NCT02924688|2935293|Other||Least Squares Mean Difference|-0.3|Standard Error of the Mean|0.692||0.662|2-Sided|95.0|-1.66|1.05||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||||
1597038|NCT02924688|2935293|Other||Least Squares Mean Difference|1.1|Standard Error of the Mean|0.697||0.115|2-Sided|95.0|-0.27|2.47||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||||
1597039|NCT02924688|2935294|Superiority||Least Squares Mean Difference|-0.089|Standard Error of the Mean|0.0338||0.008|2-Sided|95.0|-0.156|-0.023||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||||
1597159|NCT02915835|2935778|Superiority|||||||0.68|||||||ANCOVA||||
1597040|NCT02924688|2935294|Superiority||Least Squares Mean Difference|-0.057|Standard Error of the Mean|0.034||0.094|2-Sided|95.0|-0.124|0.01||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||||
1597041|NCT02924688|2935295|Superiority||Least Squares Mean Difference|0.118|Standard Error of the Mean|0.0224|<|0.001|2-Sided|95.0|0.074|0.162||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA||||
1597042|NCT02924688|2935295|Superiority||Least Squares Mean Difference|0.088|Standard Error of the Mean|0.0225|<|0.001|2-Sided|95.0|0.044|0.132||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA||||
1597043|NCT02924688|2935295|Superiority||Least Squares Mean Difference|0.111|Standard Error of the Mean|0.0225|<|0.001|2-Sided|95.0|0.067|0.155||p-value was calculated using ANCOVA with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA||||
1597044|NCT02924688|2935295|Superiority||Least Squares Mean Difference|0.088|Standard Error of the Mean|0.0226|<|0.001|2-Sided|95.0|0.044|0.132||p-value was calculated using Analysis of Covariance (ANCOVA) with covariates of treatment, age, sex, region, Baseline value, and pre-study ICS dosage at screening.|ANCOVA||||
1597045|NCT02924688|2935296|Superiority||Rate Ratio|0.87||||0.151|2-Sided|95.0|0.72|1.05||p-value was calculated using Generalized linear model with covariates for age, sex, region, treatment group, stratification by pre-study ICS dosage at screening, and severe asthma exacerbations in the previous year (0, 1, >=2).|Negative Binomial Model||Treatment policy estimand was assessed, including all on- and post-treatment data.||
1597046|NCT02924688|2935296|Superiority||Rate Ratio|0.97||||0.778|2-Sided|95.0|0.81|1.17||p-value was calculated using Generalized linear model with covariates for age, sex, region, treatment group, stratification by pre-study ICS dosage at screening, and severe asthma exacerbations in the previous year (0, 1, >=2).|Negative Binomial Model||Treatment policy estimand was assessed, including all on- and post-treatment data.||
1597047|NCT02924688|2935297|Superiority||Least Squares Mean Difference|0.092|Standard Error of the Mean|0.022|<|0.001|2-Sided|95.0|0.049|0.135||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||||
1597048|NCT02924688|2935297|Superiority||Least Squares Mean Difference|0.082|Standard Error of the Mean|0.0221|<|0.001|2-Sided|95.0|0.039|0.125||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||||
1597049|NCT02924688|2935297|Superiority||Least Squares Mean Difference|0.11|Standard Error of the Mean|0.0221|<|0.001|2-Sided|95.0|0.066|0.153||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study ICS dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||||
1597050|NCT02924688|2935297|Superiority||Least Squares Mean Difference|0.096|Standard Error of the Mean|0.0222|<|0.001|2-Sided|95.0|0.052|0.139||p-value was calculated using MMRM with covariates of treatment, age, sex, region, Baseline value, pre-study inhaled corticosteroids (ICS) dosage at screening, and visit, interaction terms for Baseline value by visit and treatment by visit.|Mixed Model Repeated Measures||||
1597051|NCT02924350|2935300|Other||Least square (LS) mean difference|-0.924|||<|0.0001|2-Sided|95.0|-1.0547|-0.7927|||ANCOVA|ANCOVA: change from baseline in Schiff sensitivity score as response and treatment as a factor and baseline Schiff sensitivity score as a covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favors first named dentifrice.||
1597052|NCT02924051|2935301|Superiority|||||||0.36|||||||t-test, 1 sided|||Comparison of Cooking Skills/Nutrition Education/MI at baseline and 12 months.|
1597053|NCT02924051|2935303|Equivalence|With an alpha level of .05 and effective (post-attrition) sample size of approximately 25 participants per county, and 3 counties per treatment group, the power of the group comparison was at least 80%, assuming an ICC of .01 or less, and an observed difference in proportions of .25. The anticipated power for the longitudinal comparison of continuous outcomes was expected to be even greater under these assumptions given the greater power for the parametric tests.|Mean Difference (Final Values)|1.12||||0.26|2-Sided|95.0|||||t-test, 2 sided||||
1597054|NCT02923895|2935307|Superiority|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.|Mean Difference (Net)|-1.31|||<|0.0001|2-Sided|95.0|-1.5|-1.128||From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment as a factor and baseline Schiff sensitivity score as a covariate.|ANCOVA||Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.||
1597055|NCT02923245|2935331|Other||Difference in percentages|15.3||||0.006|2-Sided|95.0|5.3|25.0|||Test of proportions||||
1597056|NCT02923245|2935332|Other||Mean Difference (Final Values)|49.7|||||2-Sided|95.0|23.4|77.2|||||These confidence intervals correspond to the bootstrap analysis||
1597057|NCT02922738|2935350|Superiority|||||||0.29|||||||Wilcoxon (Mann-Whitney)||||
1597058|NCT02922738|2935351|Superiority||Cox Proportional Hazard|0.92||||0.54|2-Sided|95.0|0.7|1.21|||Regression, Cox||||
1597059|NCT02921425|2935377|Other|||||||0.019|||||||Wilcoxon (Mann-Whitney)||||
1597060|NCT02921425|2935379|Other|||||||0.001|||||||t-test, 2 sided|||diastolic blood pressure|
1597061|NCT02921425|2935379|Other|||||||0.003||||||systolic blood pressure|t-test, 2 sided||||
1597062|NCT02921425|2935381|Other|||||||0.026|||||||t-test, 2 sided||||
1597063|NCT02921425|2935382|Other|||||||0.007|||||||t-test, 2 sided||||
1597064|NCT02921425|2935384|Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)||||
1597065|NCT02921087|2935399|Superiority|||||||0.87|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for phoria, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.|
1597160|NCT02915835|2935779|Superiority|||||||0.9|||||||ANCOVA||||
1597161|NCT02915835|2935780|Superiority|||||||0.54|||||||ANCOVA||||
1597066|NCT02921087|2935400|Superiority|||||||0.69|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the CLDEQ-8, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.|
1597067|NCT02921087|2935401|Superiority|||||||0.77|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the change in CISS, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.|
1597068|NCT02921087|2935402|Superiority|||||||0.01|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for accommodative response mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.|
1597069|NCT02921087|2935404|Superiority|||||||0.07|||||||Mixed Models Analysis|Least-squares adjusted means were obtained and compared.||In order to analyze the 2 x 2 crossover design for the primary outcome (change in overall VAS at day 7) mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.|
1597070|NCT02920918|2935438|Superiority|||||||0.51|||||||ANOVA||||
1597071|NCT02920918|2935439|Superiority|||||||0.083|||||||ANOVA|||We expected a baseline peak oxygen consumption (VO2) of 14.5 mL/kg/min. A sample size of 40 patients per group (total of 80 patients) provided sufficient power to detect a mean difference in the interval change in peak VO2 of 1.50±1.76 mL/kg/min (primary endpoint) expected with Canagliflozin compared to Sitagliptin, which we predict to have no significant effect on peak VO2 (0±1.76 mL/kg/min).|
1597072|NCT02920749|2935440|Superiority or Other||||||<|0.05||||||The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.|ANOVA|||Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.|
1597073|NCT02920749|2935441|Superiority or Other||||||<|0.05||||||The P value less than 0.05 was considered to be significant. With type I α = 5% and with type II (power) of 90%, we therefore needed 27 patients/group.|ANOVA|||Statistical analysis was carried out with SPSS version 21 for Windows (IBM Corporation) software. All data are expressed as means ± SD. Mann-Whitney test was performed to assess the differences between patient subgroups.|
1597074|NCT02919995|2935470|Other||Contrast ratio|0.982||||0.3693|2-Sided|95.0|0.941|1.024|||ANCOVA||||
1597075|NCT02919995|2935470|Other||Contrast ratio|1.042||||0.0333|2-Sided|95.0|1.004|1.082|||ANCOVA||||
1597076|NCT02919995|2935470|Other||Contrast ratio|1.061||||0.0093|2-Sided|95.0|1.017|1.107|||ANCOVA||||
1597077|NCT02919995|2935471|Other||Contrast ratio|0.945||||0.466|2-Sided|95.0|0.945|1.027|||ANCOVA||||
1597078|NCT02919995|2935471|Other||Contrast ratio|1.049||||0.0149|2-Sided|95.0|1.011|1.089|||ANCOVA||||
1597079|NCT02919995|2935471|Other||Contrast ratio|1.065||||0.0064|2-Sided|95.0|1.021|1.11|||ANCOVA||||
1597080|NCT02919995|2935472|Other||Contrast ratio|0.984||||0.4306|2-Sided|95.0|0.942|1.027|||ANCOVA||||
1597081|NCT02919995|2935472|Other||Contrast ratio|1.055||||0.0109|2-Sided|95.0|1.014|1.096|||ANCOVA||||
1597082|NCT02919995|2935472|Other||Contrast ratio|1.072||||0.0043|2-Sided|95.0|1.026|1.12|||ANCOVA||||
1597083|NCT02919995|2935473|Other||Contrast ratio|0.986||||0.3487|2-Sided|95.0|0.957|1.017|||ANCOVA||||
1597084|NCT02919995|2935473|Other||Contrast ratio|1.024||||0.0802|2-Sided|95.0|0.997|1.052|||ANCOVA||||
1597085|NCT02919995|2935473|Other||Contrast ratio|1.038||||0.0196|2-Sided|95.0|1.007|1.07|||ANCOVA||||
1597086|NCT02919761|2935502|Other||||||=|0||||||Comparison at Week 24|Pearson's Chi-square test||||
1597087|NCT02919761|2935502|Other||||||=|0||||||Comparison at Week 20|Pearson's Chi-square test||||
1597088|NCT02919761|2935502|Other||||||=|0||||||Comparison at Week 16|Pearson's Chi-square test||||
1597089|NCT02919761|2935502|Other||||||=|0||||||Comparison at Week 12|Pearson's Chi-square test||||
1597090|NCT02919761|2935503|Other||||||<|0.0001|||||||One-sample binomial test||||
1597091|NCT02919761|2935503|Other||||||<|0.0001||||||At Week 8|One-sample binomial test||||
1597092|NCT02919761|2935503|Other||||||=|0||||||At Week 4|One-sample binomial test||||
1597093|NCT02918279|2935653|Superiority||Treatment difference|-0.22||||0.0022|2-Sided|95.0|-0.37|-0.08|||ANCOVA||Liraglutide 3.0 mg - Placebo|Analysis of in-trial data with missing observations was imputed from the placebo arm based on a jump to reference multiple (x100) imputation approach. Responses at week 56 were analysed using an analysis of covariance model with treatment, sex, region, baseline glycaemic category, stratification factor for Tanner stage and interaction between baseline glycaemic category and stratification factor for Tanner stage as fixed effects, baseline BMI SDS, age as covariates.|
1597094|NCT02918071|2935674|Other||Percentage|1.5|||||2-Sided|95.0|0.69|2.85|||||Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 16)||
1597095|NCT02918071|2935674|Other||Percentage|3.0|||||2-Sided|95.0|1.21|6.07|||||Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12 to 16)||
1597096|NCT02918071|2935674|Other||Percentage|0.6|||||2-Sided|95.0|0.07|1.99|||||Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 0 to 8)||
1597097|NCT02918071|2935674|Other||Percentage|3.4|||||2-Sided|95.0|0.94|8.52|||||Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 16)||
1597098|NCT02918071|2935674|Other||Percentage|2.6|||||2-Sided|95.0|0.53|7.31|||||Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 12)||
1597099|NCT02918071|2935674|Other||Percentage|0.8|||||2-Sided|95.0|0.02|4.59|||||Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 8)||
1597100|NCT02918071|2935674|Other||Percentage|0.8|||||2-Sided|95.0|0.02|4.52|||||Percentage of malfunctioning AI used to administer benralizumab at home or clinic (Week 4)||
1597101|NCT02918071|2935674|Other||Percentage|0.0|||||2-Sided|95.0|0.0|3.0|||||Percentage of mulfunctioning AI used to administer benralizumab at home or clinic (Week 0)||
1597102|NCT02918071|2935675|Other||Percentage|96.6|||||2-Sided|95.0|91.48|99.06|||||Percentage of patients returned functional AI administered at home (Week 16)||
1597106|NCT02918071|2935676|Other||percentage|97.4|||||2-Sided|95.0|92.63|99.46|||||Percentage of patients successfully administered benralizumab with an AI at home (Week 12)||
1597107|NCT02917642|2935677|Superiority|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of endotoxin within the root canal system.|
1597108|NCT02917642|2935678|Superiority|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that the irrigation protocol used after the chemo-mechanical preparation does not influence the reduction of bacteria within the root canal system.|
1597109|NCT02917603|2935679|Equivalence|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|0.23|||<|0.73|2-Sided||||||t-test, 2 sided||||
1597110|NCT02917603|2935680|Equivalence|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|1.02|||<|0.06|2-Sided||||||t-test, 2 sided||||
1597111|NCT02917603|2935681|Equivalence|Null hypothesis is there will be the mean differences between baseline scores will be the same between groups. Study powered after primary outcome measure.|Mean Difference (Net)|0.46|||<|0.21|2-Sided||||||t-test, 2 sided||||
1597112|NCT02917603|2935682|Equivalence|Null hypothesis is that there would be no mean difference between baseline and last measure between intervention and control groups with p<.05|Mean Difference (Net)|0.12|||<|0.009|2-Sided||||||t-test, 2 sided|||The null hypothesis is that the mean differences between baseline and last measure in the PHQ- 9 score will not differ between groups. Study is powered a two-tailed test of significance, allowing the detection of a significant difference in either direction and the following assumptions: expected difference in PHQ-9 is 5 points, the documented clinically significant effect;78 (2) the variance of scores is 5.33; (3) error protection: α =.10, β = .20 and, (4) anticipated attrition of 15%|
1597113|NCT02917447|2935683|Superiority|||||||0.92||||||Omnibus test for difference in change from baseline in outcome by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.|||
1597114|NCT02917447|2935684|Superiority|||||||0.049||||||Omnibus test for difference in change from baseline in outcome by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.|||
1597115|NCT02917447|2935685|Superiority|||||||0.15||||||Omnibus test for difference in change from baseline in PCL by treatment group across the three post-treatment assessments, adjusted for rural/urban status and MST.|Mixed Models Analysis|Fixed effects were study assessment, group, the assessment by group interaction, and covariates. Participant was modeled as a random effect.|||
1597116|NCT02917265|2935690|Superiority|||||||0.05|||||||Chi-squared||||
1597117|NCT02915978|2935739|Other||LS Mean Difference|0.01|Standard Error of the Mean|0.8||0.9866|2-Sided|95.0|-1.6|1.63|||ANCOVA|||NRS PID at 24 hours|
1597118|NCT02915978|2935739|Other||LS Means Difference|-1.4|Standard Error of the Mean|0.82||0.0951|2-Sided|95.0|-3.06|0.26|||ANCOVA|||NRS PID at 24 hours|
1597119|NCT02915978|2935739|Other||LS Mean Difference|-1.67|Standard Error of the Mean|0.97||0.0926|2-Sided|95.0|-3.62|0.29|||ANCOVA|||NRS PID at 16 hours|
1597120|NCT02915978|2935739|Other||LS Mean Difference|-2.94|Standard Error of the Mean|0.99||0.0052|2-Sided|95.0|-4.95|-0.94|||ANCOVA|||NRS PID at 16 hours|
1597121|NCT02915978|2935739|Other||LS Mean Difference|-1.06|Standard Error of the Mean|0.9||0.2493|2-Sided|95.0|-2.89|0.77|||ANCOVA|||NRS PID at 1 hour|
1597122|NCT02915978|2935739|Other||LS Mean Difference|-1.8|Standard Error of the Mean|0.89||0.0505|2-Sided|95.0|-3.61|0.0|||ANCOVA|||NRS PID at 1 hour|
1597123|NCT02915874|2935741|Superiority||Slope|-1.02|Standard Error of the Mean|0.58||0.08|2-Sided|||||a priori threshold: 0.05|Mixed Models Analysis||||
1597124|NCT02915874|2935742|Superiority||Slope|-2.77|Standard Error of the Mean|4.93||0.58|2-Sided||||||Mixed Models Analysis||||
1597125|NCT02915874|2935743|Superiority||Slope|1.03|Standard Error of the Mean|2.58||0.69|2-Sided|||||a priori: 0.05|Mixed Models Analysis||||
1597126|NCT02915874|2935744|Superiority||Slope|-0.49|Standard Error of the Mean|21.3||0.98|2-Sided|||||a priori threshold: 0.05|Mixed Models Analysis||||
1597127|NCT02915874|2935745|Superiority||Slope|2.07|Standard Error of the Mean|1.86||0.27|2-Sided|||||a priori threshold: 0.05|Mixed Models Analysis||||
1597128|NCT02915874|2935746|Superiority||Slope|-1.02|Standard Error of the Mean|0.78||0.19|2-Sided|||||a priori threshold: 0.05|Mixed Models Analysis||||
1597129|NCT02915874|2935747|Superiority||Slope|-1.13|Standard Error of the Mean|0.47||0.02|2-Sided|||||a priori threshold: 0.05|Mixed Models Analysis||||
1597130|NCT02915835|2935748|Superiority|||||||0.14|||||||ANCOVA||||
1597131|NCT02915835|2935749|Superiority|||||||0.39|||||||ANCOVA||||
1597132|NCT02915835|2935750|Superiority|||||||0.58|||||||ANCOVA||||
1597133|NCT02915835|2935751|Superiority|||||||0.45|||||||ANCOVA||||
1597134|NCT02915835|2935752|Superiority|||||||0.32|||||||ANCOVA||||
1597135|NCT02915835|2935753|Superiority|||||||0.73|||||||ANCOVA||||
1597136|NCT02915835|2935754|Superiority|||||||1|||||||Fisher Exact||||
1597137|NCT02915835|2935755|Superiority|||||||0.47|||||||Fisher Exact||||
1597138|NCT02915835|2935756|Superiority|||||||0.32|||||||ANCOVA||||
1597139|NCT02915835|2935757|Superiority|||||||0.14|||||||ANCOVA||||
1597140|NCT02915835|2935758|Superiority|||||||0.31|||||||ANCOVA||||
1597141|NCT02915835|2935759|Superiority|||||||0.95|||||||ANCOVA||||
1597142|NCT02915835|2935760|Superiority|||||||0.75|||||||ANCOVA||||
1597143|NCT02915835|2935761|Superiority|||||||0.85|||||||ANCOVA||||
1597144|NCT02915835|2935762|Superiority|||||||0.85|||||||ANCOVA||||
1597145|NCT02915835|2935763|Superiority|||||||0.41|||||||ANCOVA||||
1597146|NCT02915835|2935764|Superiority|||||||0.14|||||||ANCOVA||||
1597147|NCT02915835|2935765|Superiority|||||||0.32|||||||ANCOVA||||
1597188|NCT02915705|2935808|Superiority||difference in LS means|7.27||||0.0496|2-Sided|95.0|0.01|14.52|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.|
1597189|NCT02915705|2935809|Superiority||difference in LS means|6.72||||0.0633|2-Sided|95.0|-0.37|13.82|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.|
1597190|NCT02915705|2935810|Superiority||difference in LS means|45.55||||0.0399|2-Sided|95.0|2.09|89.02|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.|
1597191|NCT02915705|2935811|Superiority||difference in LS means|43.46||||0.0514|2-Sided|95.0|-0.26|87.17|||GEE model|||2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.|
1597192|NCT02915705|2935812|Superiority||difference in LS means|0.05||||0.8786|2-Sided|95.0|-0.58|0.68|||GEE model|||GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.|
1597193|NCT02915705|2935813|Superiority||Difference in LS Means|0.01||||0.9862|2-Sided|95.0|-0.79|0.8|||GEE model|||GEE model includes change from baseline for FPS-R as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, baseline FPS-R as a covariate, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.|
1597194|NCT02915705|2935814|Superiority||difference in LS means|-1.08||||0.681|2-Sided|95.0|-6.21|4.06|||GEE model|||Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.|
1597195|NCT02915705|2935814|Superiority||difference in LS means|1.9||||0.3145|2-Sided|95.0|-1.8|5.59|||GEE model|||Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.|
1597196|NCT02915705|2935814|Superiority||difference in LS means|-2.26||||0.3091|2-Sided|95.0|-6.61|2.09|||GEE model|||Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.|
1597197|NCT02915705|2935815|Superiority||difference in LS means|-3.25||||0.1676|2-Sided|95.0|-7.86|1.37|||GEE model|||Fatigue Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.|
1597198|NCT02915705|2935815|Superiority||difference in LS means|2.68||||0.1009|2-Sided|95.0|-0.52|5.89|||GEE model|||Physical Function Mobility Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.|
1597199|NCT02915705|2935815|Superiority||difference in LS means|-5.02||||0.0212|2-Sided|95.0|-9.29|-0.75|||GEE model|||Pain Interference Domain. 2-sided p value per GEE model, which included change from baseline for the parameter as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline parameter measure as a covariate, with exchangeable covariance structure.|
1597200|NCT02915705|2935818|Superiority||difference|-146.56|||<|0.0001|2-Sided|95.0|-191.61|-101.52|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 64|
1597201|NCT02915705|2935818|Superiority||difference|-111.28|||<|0.0001|2-Sided|95.0|-152.08|-70.49|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 52|
1597202|NCT02915705|2935818|Superiority||difference|-95.95|||<|0.0001|2-Sided|95.0|-136.05|-55.84|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 40|
1597203|NCT02915705|2935818|Superiority||difference|-85.57|||<|0.0001|2-Sided|95.0|-126.37|-44.76|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 24|
1597204|NCT02915705|2935818|Superiority||difference|-92.53|||<|0.0001|2-Sided|95.0|-131.4|-53.66|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 16|
1597205|NCT02915705|2935820|Superiority||difference|1.25|||<|0.0001|2-Sided|95.0|0.96|1.54|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 64|
1597206|NCT02915705|2935820|Superiority||difference|1.26|||<|0.0001|2-Sided|95.0|0.97|1.54|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 52|
1597207|NCT02915705|2935820|Superiority||difference|1.35|||<|0.0001|2-Sided|95.0|1.1|1.6|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 40|
1597208|NCT02915705|2935820|Superiority||difference|1.24|||<|0.0001|2-Sided|95.0|0.98|1.51|||GEE model|||Week 32|
1597209|NCT02915705|2935820|Superiority||difference|1.11|||<|0.0001|2-Sided|95.0|0.8|1.41|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 24|
1597210|NCT02915705|2935820|Superiority||difference|1.16|||<|0.0001|2-Sided|95.0|0.84|1.48|||GEE model|||Week 16|
1597211|NCT02915705|2935820|Superiority||difference|1.42|||<|0.0001|2-Sided|95.0|1.19|1.64|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 8|
1597212|NCT02915705|2935820|Superiority||difference|1.65|||<|0.0001|2-Sided|95.0|1.28|2.02|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 4|
1597213|NCT02915705|2935822|Superiority||difference|8.7||||0.0145|2-Sided|95.0|1.72|15.68|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D|Week 64|
1597214|NCT02915705|2935822|Superiority||difference|5.01||||0.3044|2-Sided|95.0|-4.55|14.56|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 52|
1597215|NCT02915705|2935822|Superiority||difference|11.21||||0.0317|2-Sided|95.0|0.98|21.44|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 40|
1597216|NCT02915705|2935822|Superiority||difference|6.23||||0.1165|2-Sided|95.0|-1.55|14.02|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 32|
1597217|NCT02915705|2935822|Superiority||difference|10.89||||0.0101|2-Sided|95.0|2.59|19.19|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 24|
1597218|NCT02915705|2935822|Superiority||difference|12.97||||0.0078|2-Sided|95.0|3.41|22.53|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 16|
1597219|NCT02915705|2935822|Superiority||difference|15.75||||0.001|2-Sided|95.0|6.35|25.15|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 8|
1597220|NCT02915705|2935822|Superiority||difference|21.09|||<|0.0001|2-Sided|95.0|12.01|30.16|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 4|
1597221|NCT02915705|2935822|Superiority||difference|48.27|||<|0.0001|2-Sided|95.0|36.53|60.02|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 1|
1597222|NCT02915705|2935825|Superiority||difference in LS means|0.74|||<|0.0001|2-Sided|95.0|0.58|0.91|||ANCOVA||Difference (KRN23 – Oral Phosphate/Active Vitamin D)||
1597223|NCT02915705|2935827|Superiority||difference|0.69|||<|0.0001|2-Sided|95.0|0.49|0.9|||GEE model|||Week 64|
1597224|NCT02915705|2935827|Superiority||difference|0.61|||<|0.0001|2-Sided|95.0|0.39|0.82|||GEE model|||Week 52|
1597225|NCT02915705|2935827|Superiority||difference|0.71|||<|0.0001|2-Sided|95.0|0.51|0.91|||GEE model||Difference (burosumab – Oral Phosphate/Active Vitamin D)|Week 40|
1597226|NCT02915705|2935827|Superiority||difference|0.7|||<|0.0001|2-Sided|95.0|0.51|0.89|||GEE model|||Week 32|
1597227|NCT02915705|2935827|Superiority||difference|0.51|||<|0.0001|2-Sided|95.0|0.3|0.72|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 24|
1597228|NCT02915705|2935827|Superiority||difference|0.63|||<|0.0001|2-Sided|95.0|0.44|0.81|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 16|
1597229|NCT02915705|2935827|Superiority||difference|0.78|||<|0.0001|2-Sided|95.0|0.58|0.97|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 8|
1597230|NCT02915705|2935827|Superiority||difference|1.03|||<|0.0001|2-Sided|95.0|0.79|1.27|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 4|
1597231|NCT02915705|2935827|Superiority||difference|1.04|||<|0.0001|2-Sided|95.0|0.81|1.27|||GEE model||Difference (Burosumab – Oral Phosphate/Active Vitamin D)|Week 1|
1597232|NCT02915705|2935828|Superiority||difference in LS means|1.12||||0.0047|2-Sided|95.0|0.37|1.88|||ANCOVA|||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.|
1597233|NCT02915705|2935829|Superiority||difference in LS means|1.02||||0.0386|2-Sided|95.0|0.06|1.99|||ANCOVA|||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included change from baseline for growth velocity Z score as the dependent variable, treatment group and baseline RSS total score stratification as factors, baseline Z score and age as continuous covariates.|
1597234|NCT02915705|2935830|Superiority||difference in LS means|0.14||||0.049|2-Sided|95.0|0.0|0.29|||GEE model|||LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.|
1597235|NCT02915705|2935831|Superiority||LS Mean Difference|0.12||||0.0408|2-Sided|95.0|0.01|0.24|||GEE model|||LS mean, SE, CI, and 2-sided p value per GEE model, which included change from baseline for recumbent length/standing height Z score as the dependent variable, treatment group, visit, interaction between treatment group by visit and baseline RSS stratification as factors, age and baseline recumbent length/standing height Z score as continuous covariates, with exchangeable covariance structure.|
1597236|NCT02915705|2935832|Superiority||difference in LS means|0.97|||<|0.0001|2-Sided|95.0|0.57|1.37||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.|GEE model||||
1597237|NCT02915705|2935833|Superiority||LS Mean Difference|0.4||||0.0162|2-Sided|95.0|0.07|0.72||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction, and baseline age stratification factor as factors; and baseline RSS score as a continuous covariate.|GEE model||||
1597238|NCT02915705|2935834|Superiority||difference in LS means|-1.21|||<|0.0001|2-Sided|95.0|-1.59|-0.83||LS mean, SE, CI, and 2-sided p value per GEE model, which included treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate.|GEE model||||
1597239|NCT02915705|2935835|Superiority||LS Mean Difference|-1.34|||<|0.0001|2-Sided|95.0|-1.74|-0.94||LS mean, SE, CI, and 2-sided p value per ANCOVA model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.|ANCOVA||||
1597240|NCT02915705|2935836|Superiority||difference in LS means|1.02|||<|0.0001|2-Sided|95.0|0.72|1.33|||GEE model|||Per generalized estimating equation (GEE) model, which included RGI-C as the dependent variable, treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS score as a continuous covariate, with exchangeable covariate structure.|
1597241|NCT02915705|2935837|Superiority||Odds Ratio (OR)|34.1||||0.0002|2-Sided|95.0|5.6|206.3||Odds ratio, CI, and 2-sided p-value were per generalized linear mixed model, which includes treatment, visit, treatment by visit interaction and baseline age stratification factor as factors, baseline RSS total score as a continuous covariate.|generalized linear mixed model||||
1597242|NCT02915705|2935838|Superiority||Odds Ratio (OR)|39.1|||<|0.0001|2-Sided|95.0|7.2|211.7||Odds ratio, CI, and 2-sided p-value were per logistic regression model, which included treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.|Regression, Logistic||||
1597243|NCT02915705|2935839|Superiority||LS Mean Difference|1.14|||<|0.0001|2-Sided|95.0|0.83|1.45|||ANCOVA|||Least squares (LS) mean, standard error (SE), confidence interval (CI), and 2-sided p value per ANCOVA model, which included RGI-C as the dependent variable, treatment group and baseline age stratification factor as independent variables and baseline RSS score as a continuous covariate.|
1597244|NCT02915302|2935840|Non-Inferiority|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was >-10%.|Difference in SCR (B Yamagata lineage)|3.4|||||2-Sided|95.0|-0.465|7.36|||||B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Yamagata lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.|
1597245|NCT02915302|2935840|Non-Inferiority|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was >-10%.|Difference in SCR (B Victoria lineage)|1.4|||||2-Sided|95.0|-2.78|5.56|||||B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Victoria lineage strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.|
1597246|NCT02915302|2935840|Non-Inferiority|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was >-10%.|Difference in SCR (A/H3N2)|4.3|||||2-Sided|95.0|-0.283|8.99|||||A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H3N2 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.|
1597247|NCT02915302|2935840|Non-Inferiority|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in SCRs was >-10%.|Difference in SCR (A/H1N1)|5.1|||||2-Sided|95.0|0.189|10.0|||||A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H1N1 strain, difference in SCR was defined as SCR after 0.5-mL dose(s) of Fluzone Quadrivalent Vaccine minus SCR after 0.25-mL dose(s) of Fluzone Quadrivalent Vaccine.|
1597248|NCT02915302|2935841|Non-Inferiority|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was >0.667.|GMTs Ratio (B Yamagata lineage)|1.44|||||2-Sided|95.0|1.2|1.73|||||B Yamagata lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Yamagata lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.|
1597249|NCT02915302|2935841|Non-Inferiority|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was >0.667.|GMTs Ratio (B Victoria lineage)|1.33|||||2-Sided|95.0|1.1|1.62|||||B Victoria lineage strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For B Victoria lineage strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.|
1597250|NCT02915302|2935841|Non-Inferiority|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was >0.667.|GMTs Ratio (A/H3N2)|1.5|||||2-Sided|95.0|1.23|1.83|||||A/H3N2 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H3N2 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.|
1597251|NCT02915302|2935841|Non-Inferiority|Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the ratio of GMTs was >0.667.|GMTs Ratio (A/H1N1)|1.45|||||2-Sided|95.0|1.19|1.77|||||A/H1N1 strain: Fluzone Quadrivalent Vaccine (0.5-mL vs. 0.25-mL)|For A/H1N1 strain, GMT ratio was defined as the GMT after 0.5 mL dose(s) of Fluzone Quadrivalent vaccine divided by the GMT after 0.25 mL dose(s) of Fluzone Quadrivalent vaccine.|
1597252|NCT02915302|2935842|Non-Inferiority|Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval (CI) of the difference in fever rate was <5%.|Difference in Fever Rate|0.84|||||2-Sided|95.0|-2.13|3.8|||||Fever rate: Fluzone Quadrivalent vaccine (0.5-mL vs. 0.25-mL)|Difference in fever rate was defined as the fever rate following a 0.5-mL dose of Fluzone Quadrivalent vaccine minus the fever rate following a 0.25-mL dose of Fluzone Quadrivalent vaccine.|
1597253|NCT02915159|2935878|Superiority|||||||0.5841|||||||longitudinal repeated measures analysis||||
1597254|NCT02915159|2935879|Superiority|||||||0.3367|||||||longitudinal repeated measures analysis||||
1597255|NCT02915159|2935880|Superiority|||||||0.4421|||||||longitudinal repeated measures analysis||||
1597256|NCT02915029|2935900|Superiority|The primary hypothesis being tested was that the intervention will increase patient activation.|Mean Difference (Net)|8.7||||0.01|2-Sided|95.0|1.9|15.5|||ANCOVA|Primary outcome was change in PAM total score, adjusted for baseline level. Adjusting for family clustering with generalized estimated equations.|This reflects the between-group difference for the within-person change scores in PAM total score adjusting for baseline values per person.|Group 1(usual care) is the comparison group, group 2 is the intervention group.|Applied generalized estimating equations (GEE) to account for within family (household) clustering.
1597257|NCT02914275|2935909|Non-Inferiority|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|0.9|||||2-Sided|95.0|-4.2|6.1||||||Non-inferiority of immune responses to B/VIC vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination|
1597258|NCT02914275|2935909|Non-Inferiority|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|3.1|||||2-Sided|95.0|-2.1|8.2||||||Non-inferiority of immune responses to B/YAM vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination|
1598440|NCT02900378|2936704|Other|||||||0.2933|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12|
1597259|NCT02914275|2935909|Non-Inferiority|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|2.6|||||2-Sided|95.0|-2.54|7.8||||||Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination|
1597260|NCT02914275|2935909|Non-Inferiority|The noninferiority criterion for the SCR difference was that the upper bound of the two-sided 95% CI on the difference between SCRs for Comparator QIV minus the Seqirus QIV SCR should not exceed 10%.|Seroconversion Rate Difference|-10.3|||||2-Sided|95.0|-15.4|-5.1||||||Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Seroconversion Rate Difference 28 days after the last vaccination|
1597261|NCT02914275|2935910|Non-Inferiority|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|0.97|||||2-Sided|95.0|0.86|1.09||||||Non-inferiority of immune responses to B/VIC vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination|
1597262|NCT02914275|2935910|Non-Inferiority|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|1.12|||||2-Sided|95.0|1.01|1.24||||||Non-inferiority of immune responses to B/YAM vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination|
1597263|NCT02914275|2935910|Non-Inferiority|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|1.27|||||2-Sided|95.0|1.15|1.42||||||Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination|
1597264|NCT02914275|2935910|Non-Inferiority|The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% confidence interval (CI) of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5|Geometric Mean Titer Ratio|0.79|||||2-Sided|95.0|0.72|0.88||||||Non-inferiority of immune responses to A/H1N1 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination|
1597265|NCT02914236|2935914|Superiority||||||<|0.0001|||||||binomial test|Success threshold required at least 55% of subjects to be responders|||
1597266|NCT02914236|2935915|Superiority||||||<|0.0001|||||||t-test, 2 sided|Hypothesis was that the mean improvement in NOSE score exceeded 15 points|||
1597267|NCT02914184|2935936|Non-Inferiority|LL of the two-sided 95% CI for the ratio of anti-RV IgA antibody GMCs between the Liq_Pool Group and Control group should be ≥ 0.67.|GMC Ratio at At Month 2-4|1.04|||||2-Sided|95.0|0.82|1.33||||||Non-inferiority of Liq_Pool Group as compared to Lyo Control group in terms of the GMC ratio calculated using ANOVA model with vaccine groups and country as fixed effects|
1597268|NCT02914184|2935938|Non-Inferiority|Lower limit (LL) of the two-sided asymptotic standardized 95% CI for the difference in SCR for antibodies to rota virus at month 2-4 between the Liq_Pool group and Lyo Control group should be ≥ -10%.|SCR difference at Month 2-4|-2.49|||||2-Sided|95.0|-7.15|2.63||||||Non-inferiority of Liq_Pool group compared to Lyo Control group in terms of difference in % of subjects with anti-RV IgA titer ≥ specified cut off with its 2-sided 95% CI in initially seronegative subjects|
1597269|NCT02914184|2935939|Other|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the [0.5; 2] clinical limit interval.|GMC Ratio at At Month 2-4|0.82|||||2-Sided|95.0|0.61|1.11||||||GMC Ratio of Anti-RV IgA antibody for Liq_B and Liq_C groups was calculated using ANOVA model with vaccine groups and country as fixed effects.|
1597270|NCT02914184|2935939|Other|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the [0.5; 2] clinical limit interval.|GMC Ratio at At Month 2-4|0.88|||||2-Sided|95.0|0.65|1.19||||||GMC Ratio of Anti-RV IgA antibody for Liq_A and Liq_C groups was calculated using ANOVA model with vaccine groups and country as fixed effects.|
1597271|NCT02914184|2935939|Other|The two-sided 95% CIs for the ratio of anti RV IgA antibody GMCs should be within the [0.5; 2] clinical limit interval.|GMC Ratio at At Month 2-4|1.07|||||2-Sided|95.0|0.79|1.44||||||GMC Ratio of Anti-RV IgA antibody for Liq_A and Liq_B groups was calculated using ANOVA model with vaccine groups and country as fixed effects.|
1597272|NCT02913222|2935958|Other|The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.|Mean Difference (Final Values)|-5.55||||0.14|2-Sided|95.0|-13.1|1.99||The threshold for statistical significance was p = 0.05.|ANCOVA|||We hypothesized MPT would demonstrate greater improvement in HOOS compared to Standard. Data collected at pretest and posttest were analyzed with ANCOVA where posttest was the dependent variable, pretest was the covariate, and treatment group was the independent variable which tests the null hypothesis that after adjusting for pretest, posttest is not significantly different across treatment groups.|
1597273|NCT02913222|2935959|Other|The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.|Mean Difference (Final Values)|-2.2||||0.32|2-Sided|95.0|-6.51|2.11||The threshold for statistical significance was p = 0.05|ANCOVA|||We hypothesized MPT would demonstrate greater improvement in HOOS compared to Standard. Data collected at pretest and posttest were analyzed with ANCOVA where posttest was the dependent variable, pretest was the covariate, and treatment group was the independent variable which tests the null hypothesis that after adjusting for pretest, posttest is not significantly different across treatment groups.|
1597274|NCT02913222|2935960|Other|||||||1||||||The threshold for statistical significance was set at p = 0.05.|Fisher Exact|||A priori criteria for success was that we would achieve 90% adherence to attending treatment sessions. Fisher’s exact test compared patient adherence to treatment session rates by site and by group.|
1597275|NCT02913105|2935961|Superiority|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|0.22|Standard Error of the Mean|4.93||0.9645|2-Sided|90.0|-7.974|8.414|||ANCOVA||||
1598441|NCT02900378|2936704|Other|||||||0.7247|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11|
1597276|NCT02913105|2935961|Superiority|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|7.23|Standard Error of the Mean|5.62||0.2014|2-Sided|90.0|-2.106|16.563|||ANCOVA||||
1597277|NCT02913105|2935961|Other|Change from baseline was analyzed using an ANCOVA model which included effects for treatment, baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|7.01|Standard Error of the Mean|5.52||0.2073|2-Sided|90.0|-2.161|16.178|||ANCOVA||||
1597278|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.02||||0.7503|2-Sided|90.0|0.92|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)|
1597279|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.08||||0.1749|2-Sided|90.0|0.98|1.2|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84|
1597280|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.08||||0.1524|2-Sided|90.0|0.99|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56|
1597281|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.14||||0.0159|2-Sided|90.0|1.04|1.24|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42|
1597282|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.06||||0.1822|2-Sided|90.0|0.99|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28|
1597283|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.13||||0.0052|2-Sided|90.0|1.05|1.21|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14|
1597284|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.1||||0.016|2-Sided|90.0|1.03|1.18|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7|
1597285|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.0||||0.9577|2-Sided|90.0|0.89|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)|
1597286|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.02||||0.7519|2-Sided|90.0|0.92|1.14|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84|
1597287|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.04||||0.5246|2-Sided|90.0|0.94|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56|
1597288|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.06||||0.3261|2-Sided|90.0|0.96|1.17|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42|
1597453|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|43.16|||<|0.001|2-Sided|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597289|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.97||||0.6035|2-Sided|90.0|0.9|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28|
1597290|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.02||||0.6576|2-Sided|90.0|0.95|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14|
1597291|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.04||||0.318|2-Sided|90.0|0.97|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7|
1597292|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.98||||0.7281|2-Sided|90.0|0.88|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 112 (EOS)|
1597293|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.94||||0.3419|2-Sided|90.0|0.85|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 84|
1597294|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.96||||0.4928|2-Sided|90.0|0.87|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 56|
1597295|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.93||||0.2199|2-Sided|90.0|0.85|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 42|
1597296|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.92||||0.0719|2-Sided|90.0|0.85|0.99|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 28|
1597297|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.91||||0.0219|2-Sided|90.0|0.84|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 14|
1597298|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.95||||0.1783|2-Sided|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||LDL Cholesterol Friedwald: Day 7|
1597299|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.01||||0.774|2-Sided|90.0|0.95|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)|
1597300|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.88||||0.0031|2-Sided|90.0|0.82|0.94|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84|
1597301|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.92||||0.0217|2-Sided|90.0|0.86|0.98|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56|
1620545|NCT02314923|2977569|Other||||||<|0.001|||||||ANOVA||||
1597302|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.91||||0.0105|2-Sided|90.0|0.86|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42|
1597303|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.91||||0.008|2-Sided|90.0|0.87|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28|
1597304|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.98||||0.6237|2-Sided|90.0|0.93|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14|
1597305|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.93||||0.009|2-Sided|90.0|0.89|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7|
1597306|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.95||||0.228|2-Sided|90.0|0.89|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)|
1597307|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.84||||0.0002|2-Sided|90.0|0.78|0.9|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84|
1597308|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.82|||<|0.0001|2-Sided|90.0|0.77|0.88|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56|
1597309|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.86|||<|0.0002|2-Sided|90.0|0.81|0.92|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42|
1597310|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.83|||<|0.0001|2-Sided|90.0|0.79|0.88|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28|
1597311|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.88|||<|0.0001|2-Sided|90.0|0.83|0.93|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14|
1597312|NCT02913105|2935962|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.85|||<|0.0001|2-Sided|90.0|0.81|0.89|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7|
1597313|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.94|||<|0.1331|2-Sided|90.0|0.88|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 112 (EOS)|
1597314|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.95|||<|0.2615|2-Sided|90.0|0.89|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 84|
1598442|NCT02900378|2936704|Other|||||||0.4444|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10|
1597315|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.9|||<|0.0043|2-Sided|90.0|0.84|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 56|
1597316|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.94|||<|0.1214|2-Sided|90.0|0.89|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 42|
1597317|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.91|||<|0.0062|2-Sided|90.0|0.86|0.96|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 28|
1597318|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.89|||<|0.0005|2-Sided|90.0|0.84|0.94|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 14|
1597319|NCT02913105|2935962|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.91|||<|0.0005|2-Sided|90.0|0.87|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||HDL Cholesterol: Day 7|
1597320|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.0||||0.9892|2-Sided|90.0|0.87|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)|
1597321|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.03||||0.7261|2-Sided|90.0|0.89|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84|
1597322|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.04||||0.6015|2-Sided|90.0|0.92|1.17|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56|
1597323|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.98||||0.7372|2-Sided|90.0|0.87|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42|
1597324|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.0||||0.9572|2-Sided|90.0|0.88|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28|
1597325|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.9||||0.1125|2-Sided|90.0|0.8|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14|
1597326|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.86||||0.0179|2-Sided|90.0|0.77|0.95|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7|
1597327|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.89||||0.2414|2-Sided|90.0|0.76|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)|
1598443|NCT02900378|2936704|Other|||||||0.7209|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9|
1597328|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.88||||0.1803|2-Sided|90.0|0.75|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84|
1597329|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.98||||0.7752|2-Sided|90.0|0.86|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56|
1597330|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.92||||0.307|2-Sided|90.0|0.8|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42|
1597331|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.96||||0.5755|2-Sided|90.0|0.84|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28|
1597332|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.85||||0.0291|2-Sided|90.0|0.76|0.96|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14|
1597333|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.87||||0.0324|2-Sided|90.0|0.78|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7|
1597334|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.89||||0.226|2-Sided|90.0|0.77|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 112 (EOS)|
1597335|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.85||||0.0891|2-Sided|90.0|0.73|0.99|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 84|
1597336|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.94||||0.4342|2-Sided|90.0|0.83|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 56|
1597337|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.94||||0.447|2-Sided|90.0|0.83|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 42|
1597338|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.96||||0.6022|2-Sided|90.0|0.84|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 28|
1597339|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.95||||0.4817|2-Sided|90.0|0.85|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 14|
1597340|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.01||||0.8891|2-Sided|90.0|0.91|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||Triglycerides: Day 7|
1598177|NCT02912650|2935992|Superiority or Other|||||||0.005|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1597341|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.03||||0.3648|2-Sided|90.0|0.97|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)|
1597342|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.03||||0.4901|2-Sided|90.0|0.96|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84|
1597343|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.03||||0.4256|2-Sided|90.0|0.97|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56|
1597344|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.05||||0.159|2-Sided|90.0|0.99|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42|
1597345|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.01||||0.699|2-Sided|90.0|0.96|1.07|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28|
1597346|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.03||||0.236|2-Sided|90.0|0.99|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14|
1597347|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.0||||0.9244|2-Sided|90.0|0.96|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7|
1597348|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.97||||0.5031|2-Sided|90.0|0.91|1.04|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)|
1597349|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.96||||0.3621|2-Sided|90.0|0.9|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84|
1597350|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.98||||0.6091|2-Sided|90.0|0.92|1.05|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56|
1597351|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.99||||0.8365|2-Sided|90.0|0.93|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42|
1597352|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.94||||0.0744|2-Sided|90.0|0.89|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28|
1597353|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.96||||0.151|2-Sided|90.0|0.91|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14|
1597697|NCT02912650|2935981|Superiority or Other||LS Mean Difference|2.61|||<|0.001|2-Sided|95.0|1.19|4.02|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597354|NCT02913105|2935963|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.96||||0.0771|2-Sided|90.0|0.92|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7|
1597355|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.94||||0.1342|2-Sided|90.0|0.88|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 112 (EOS)|
1597356|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.94||||0.1141|2-Sided|90.0|0.87|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 84|
1597357|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.95||||0.2032|2-Sided|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 56|
1597358|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.95||||0.133|2-Sided|90.0|0.89|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 42|
1597359|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.93||||0.0284|2-Sided|90.0|0.88|0.98|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 28|
1597360|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.93||||0.0096|2-Sided|90.0|0.88|0.97|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 14|
1597361|NCT02913105|2935963|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.96||||0.0858|2-Sided|90.0|0.92|1.0|||ANCOVA|An unstructured variance-covariance structure was used.||Cholesterol: Day 7|
1597362|NCT02913105|2935964|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.02||||0.5361|2-Sided|90.0|0.96|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84|
1597363|NCT02913105|2935964|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.01||||0.8083|2-Sided|90.0|0.96|1.06|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42|
1597364|NCT02913105|2935964|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.08||||0.0717|2-Sided|90.0|1.01|1.15|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84|
1597365|NCT02913105|2935964|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.06||||0.1051|2-Sided|90.0|1.0|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42|
1597366|NCT02913105|2935964|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.05||||0.2048|2-Sided|90.0|0.98|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 84|
1597698|NCT02912650|2935981|Superiority or Other||LS Mean Difference|2.27|||<|0.028|2-Sided|95.0|0.25|4.28|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597367|NCT02913105|2935964|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.05||||0.1458|2-Sided|90.0|0.99|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||TIMP-1: Day 42|
1597368|NCT02913105|2935964|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.01||||0.905|2-Sided|90.0|0.92|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84|
1597369|NCT02913105|2935964|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.03||||0.5873|2-Sided|90.0|0.94|1.13|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42|
1597370|NCT02913105|2935964|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.0||||0.9988|2-Sided|90.0|0.91|1.1|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84|
1597371|NCT02913105|2935964|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.01||||0.9131|2-Sided|90.0|0.91|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42|
1597372|NCT02913105|2935964|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.99||||0.9145|2-Sided|90.0|0.9|1.09|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 84|
1597373|NCT02913105|2935964|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.98||||0.6935|2-Sided|90.0|0.88|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||PIIINP: Day 42|
1597374|NCT02913105|2935964|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.03||||0.8074|2-Sided|90.0|0.85|1.25|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84|
1597375|NCT02913105|2935964|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.9||||0.4127|2-Sided|90.0|0.73|1.11|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42|
1597376|NCT02913105|2935964|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.91||||0.4446|2-Sided|90.0|0.73|1.12|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84|
1597377|NCT02913105|2935964|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.86||||0.288|2-Sided|90.0|0.69|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42|
1597378|NCT02913105|2935964|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.88||||0.3086|2-Sided|90.0|0.72|1.08|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 84|
1597379|NCT02913105|2935964|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.96||||0.739|2-Sided|90.0|0.77|1.19|||ANCOVA|An unstructured variance-covariance structure was used.||HA: Day 42|
1597699|NCT02912650|2935981|Superiority or Other||LS Mean Difference|4.87|||<|0.001|2-Sided|95.0|2.87|6.88|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597380|NCT02913105|2935965|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.0||||0.7517|2-Sided|90.0|0.98|1.03|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84|
1597381|NCT02913105|2935965|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.99||||0.664|2-Sided|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42|
1597382|NCT02913105|2935965|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.99||||0.6329|2-Sided|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84|
1597383|NCT02913105|2935965|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.99||||0.639|2-Sided|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42|
1597384|NCT02913105|2935965|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.99||||0.4344|2-Sided|90.0|0.96|1.01|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84|
1597385|NCT02913105|2935965|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|1.0||||0.9453|2-Sided|90.0|0.97|1.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42|
1597386|NCT02913105|2935966|Superiority|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.93||||0.374|2-Sided|90.0|0.8|1.07|||ANCOVA||||
1597387|NCT02913105|2935966|Superiority|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.93||||0.5168|2-Sided|90.0|0.78|1.12|||ANCOVA||||
1597388|NCT02913105|2935966|Other|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|1.01||||0.9514|2-Sided|90.0|0.84|1.21|||ANCOVA||||
1597389|NCT02913105|2935967|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|0.001|Standard Error of the Mean|0.01||0.8883|2-Sided|90.0|-0.015|0.017|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)|
1597390|NCT02913105|2935967|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.016|Standard Error of the Mean|0.01||0.1272|2-Sided|90.0|-0.032|0.001|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84|
1597391|NCT02913105|2935967|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|0.002|Standard Error of the Mean|0.007||0.7423|2-Sided|90.0|-0.009|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56|
1597392|NCT02913105|2935967|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.006|Standard Error of the Mean|0.012||0.62|2-Sided|90.0|-0.025|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42|
1597393|NCT02913105|2935967|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|0.006|Standard Error of the Mean|0.008||0.4923|2-Sided|90.0|-0.008|0.02|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28|
1597700|NCT02912650|2935981|Superiority or Other||LS Mean Difference|4.34|||<|0.001|2-Sided|95.0|2.92|5.76|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597394|NCT02913105|2935967|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.011||0.8015|2-Sided|90.0|-0.021|0.016|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)|
1597395|NCT02913105|2935967|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.007|Standard Error of the Mean|0.011||0.5695|2-Sided|90.0|-0.025|0.012|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84|
1597396|NCT02913105|2935967|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|0.003|Standard Error of the Mean|0.008||0.6844|2-Sided|90.0|-0.01|0.016|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56|
1597397|NCT02913105|2935967|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|0.008|Standard Error of the Mean|0.013||0.5496|2-Sided|90.0|-0.014|0.03|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42|
1597398|NCT02913105|2935967|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|0.006|Standard Error of the Mean|0.009||0.5367|2-Sided|90.0|-0.009|0.021|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28|
1597399|NCT02913105|2935967|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.004|Standard Error of the Mean|0.011||0.7001|2-Sided|90.0|-0.022|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)|
1597400|NCT02913105|2935967|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|0.009|Standard Error of the Mean|0.011||0.4163|2-Sided|90.0|-0.009|0.027|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84|
1597401|NCT02913105|2935967|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|0.001|Standard Error of the Mean|0.007||0.9032|2-Sided|90.0|-0.012|0.013|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56|
1597402|NCT02913105|2935967|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|0.014|Standard Error of the Mean|0.013||0.2794|2-Sided|90.0|-0.007|0.035|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42|
1597403|NCT02913105|2935967|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.009||0.9927|2-Sided|90.0|-0.015|0.014|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28|
1597404|NCT02913105|2935968|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.686|Standard Error of the Mean|0.244||0.006|2-Sided|90.0|-1.091|-0.281|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)|
1597405|NCT02913105|2935968|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.608|Standard Error of the Mean|0.221||0.007|2-Sided|90.0|-0.975|-0.242|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84|
1597406|NCT02913105|2935968|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.402|Standard Error of the Mean|0.165||0.0162|2-Sided|90.0|-0.676|-0.129|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56|
1597454|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|50.74|||<|0.001|2-Sided|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597407|NCT02913105|2935968|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.315|Standard Error of the Mean|0.156||0.0457|2-Sided|90.0|-0.574|-0.056|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42|
1597408|NCT02913105|2935968|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.208|Standard Error of the Mean|0.129||0.1092|2-Sided|90.0|-0.423|0.006|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28|
1597409|NCT02913105|2935968|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.759|Standard Error of the Mean|0.275||0.007|2-Sided|90.0|-1.216|-0.302|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)|
1597410|NCT02913105|2935968|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.657|Standard Error of the Mean|0.247||0.0091|2-Sided|90.0|-1.067|-0.247|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84|
1597411|NCT02913105|2935968|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.183||0.0085|2-Sided|90.0|-0.793|-0.187|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56|
1597412|NCT02913105|2935968|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.338|Standard Error of the Mean|0.172||0.052|2-Sided|90.0|-0.623|-0.053|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42|
1597413|NCT02913105|2935968|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.241|Standard Error of the Mean|0.141||0.0911|2-Sided|90.0|-0.476|-0.006|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28|
1597414|NCT02913105|2935968|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.073|Standard Error of the Mean|0.266||0.7839|2-Sided|90.0|-0.515|0.369|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)|
1597415|NCT02913105|2935968|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.048|Standard Error of the Mean|0.238||0.8398|2-Sided|90.0|-0.444|0.347|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84|
1597416|NCT02913105|2935968|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.088|Standard Error of the Mean|0.177||0.6209|2-Sided|90.0|-0.381|0.205|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56|
1597417|NCT02913105|2935968|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.023|Standard Error of the Mean|0.166||0.8901|2-Sided|90.0|-0.298|0.252|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42|
1597418|NCT02913105|2935968|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.033|Standard Error of the Mean|0.137||0.8127|2-Sided|90.0|-0.26|0.195|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28|
1597419|NCT02913105|2935969|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-1.909|Standard Error of the Mean|0.7||0.0076|2-Sided|90.0|-3.072|-0.746|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)|
1597455|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|13.98|||<|0.002|2-Sided|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597420|NCT02913105|2935969|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-1.63|Standard Error of the Mean|0.635||0.0118|2-Sided|90.0|-2.684|-0.575|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84|
1597421|NCT02913105|2935969|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-1.116|Standard Error of the Mean|0.455||0.0159|2-Sided|90.0|-1.872|-0.36|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56|
1597422|NCT02913105|2935969|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.786|Standard Error of the Mean|0.444||0.0797|2-Sided|90.0|-1.524|-0.049|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42|
1597423|NCT02913105|2935969|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.519|Standard Error of the Mean|0.368||0.1609|2-Sided|90.0|-1.13|0.091|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28|
1597424|NCT02913105|2935969|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-2.123|Standard Error of the Mean|0.793||0.0087|2-Sided|90.0|-3.439|-0.807|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)|
1597425|NCT02913105|2935969|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-1.787|Standard Error of the Mean|0.71||0.0134|2-Sided|90.0|-2.965|-0.609|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84|
1597426|NCT02913105|2935969|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-1.344|Standard Error of the Mean|0.505||0.009|2-Sided|90.0|-2.182|-0.506|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56|
1597427|NCT02913105|2935969|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.93|Standard Error of the Mean|0.49||0.0603|2-Sided|90.0|-1.743|-0.117|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42|
1597428|NCT02913105|2935969|Superiority|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.598|Standard Error of the Mean|0.402||0.1403|2-Sided|90.0|-1.265|0.07|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28|
1597429|NCT02913105|2935969|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.214|Standard Error of the Mean|0.766||0.7804|2-Sided|90.0|-1.485|1.057|||ANCOVA|An unstructured variance-covariance structure was used.||Day 112 (EOS)|
1597430|NCT02913105|2935969|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.158|Standard Error of the Mean|0.685||0.8185|2-Sided|90.0|-1.294|0.979|||ANCOVA|An unstructured variance-covariance structure was used.||Day 84|
1597431|NCT02913105|2935969|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.228|Standard Error of the Mean|0.487||0.6406|2-Sided|90.0|-1.037|0.581|||ANCOVA|An unstructured variance-covariance structure was used.||Day 56|
1597432|NCT02913105|2935969|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.144|Standard Error of the Mean|0.472||0.7607|2-Sided|90.0|-0.927|0.639|||ANCOVA|An unstructured variance-covariance structure was used.||Day 42|
1597456|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|6.07|||<|0.136|2-Sided|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597433|NCT02913105|2935969|Other|Change from baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), baseline and baseline by visit interaction. BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Mean Difference (Final Values)|-0.079|Standard Error of the Mean|0.389||0.8402|2-Sided|90.0|-0.724|0.567|||ANCOVA|An unstructured variance-covariance structure was used.||Day 28|
1597434|NCT02913105|2935970|Superiority|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.71|||<|0.0001|2-Sided|90.0|0.63|0.8|||ANCOVA||||
1597435|NCT02913105|2935970|Superiority|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.68|||<|0.0001|2-Sided|90.0|0.59|0.78|||ANCOVA||||
1597436|NCT02913105|2935970|Other|Log transformed ratio to baseline was analyzed using an ANCOVA model which included effects for treatment, log-transformed baseline and stratification factor (BMI group). BMI was separated into two groups, low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian =30 and Non-Asian=35).|Geometric Mean Ratios|0.95|||<|0.5354|2-Sided|90.0|0.83|1.09|||ANCOVA||||
1597437|NCT02913105|2935975|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.74||||0.0005|2-Sided|90.0|0.65|0.85|||ANCOVA|An unstructured variance-covariance structure was used.|||
1597438|NCT02913105|2935975|Superiority|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (BMI group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.72||||0.0005|2-Sided|90.0|0.62|0.84|||ANCOVA|An unstructured variance-covariance structure was used.|||
1597439|NCT02913105|2935975|Other|Log transformed ratio to baseline was analyzed using a repeated measures model which included effects for treatment, visit, treatment by visit interaction, stratification factor (Body Mass Index (BMI) group), log-transformed baseline and log-transformed baseline by visit interaction. BMI was separated into two groups low BMI (Asian<30 and Non-Asian<35) and high BMI (Asian >=30 and Non-Asian>=35).|Geometric Mean Ratios|0.97||||0.7489|2-Sided|90.0|0.83|1.13|||ANCOVA|An unstructured variance-covariance structure was used.|||
1597440|NCT02912650|2935977|Superiority or Other|||||||0.003|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.|
1597441|NCT02912650|2935977|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.|
1597442|NCT02912650|2935977|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.|
1597443|NCT02912650|2935977|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.|
1597444|NCT02912650|2935977|Superiority or Other||||||<|0.004|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.|
1597445|NCT02912650|2935977|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value was calculated from CMH test with modified ridit scores, controlling for baseline categorical PSR and gender.|
1597446|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|7.91||||0.087|2-Sided|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597447|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|43.16|||<|0.001|2-Sided|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597448|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|50.74|||<|0.001|2-Sided|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597449|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|13.98|||<|0.002|2-Sided|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597450|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|6.07|||<|0.136|2-Sided|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597451|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|56.94|||<|0.001|2-Sided|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597452|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|7.91|||<|0.087|2-Sided|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1598444|NCT02900378|2936704|Other|||||||0.3941|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8|
1597457|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|56.94|||<|0.001|2-Sided|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597458|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|7.91|||<|0.087|2-Sided|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597459|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|43.16|||<|0.001|2-Sided|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597460|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|50.74|||<|0.001|2-Sided|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597461|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|13.98|||<|0.002|2-Sided|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597462|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|6.07|||<|0.136|2-Sided|95.0|-1.91|14.05|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597463|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|56.94|||<|0.001|2-Sided|95.0|43.95|69.94|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597464|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|7.36|||<|0.113|2-Sided|95.0|-1.73|16.45|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597465|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|44.89|||<|0.001||95.0|31.51|58.26|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597466|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|51.9|||<|0.001|2-Sided|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597467|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|13.98|||<|0.002|2-Sided|95.0|5.3|22.67|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597468|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|6.64|||<|0.105|2-Sided|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597469|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|58.71|||<|0.001||95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597470|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|8.61|||<|0.065|2-Sided|95.0|-0.55|17.76|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597471|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|43.61|||<|0.001|2-Sided|95.0|30.15|57.07|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597472|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|51.9|||<|0.001||95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597473|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|15.23|||<|0.001|2-Sided|95.0|6.48|23.97|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597474|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|6.64|||<|0.105|2-Sided|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores|
1597475|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|58.71|||<|0.001||95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores|
1597476|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|9.23|||<|0.048|2-Sided|95.0|0.06|18.4|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1620546|NCT02314923|2977569|Other||||||<|0.071|||||||ANOVA||||
1597477|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|42.94|||<|0.001|2-Sided|95.0|29.44|56.44|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597478|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|51.9|||<|0.001|2-Sided|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597479|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|15.86|||<|0.001|2-Sided|95.0|7.08|24.63|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597480|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|6.64|||<|0.105|2-Sided|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597481|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|58.71|||<|0.001|2-Sided|95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597482|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|9.23|||<|0.048|2-Sided|95.0|0.06|18.4|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597483|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|42.94|||<|0.001|2-Sided|95.0|29.44|56.44|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597484|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|51.9|||<|0.001|2-Sided|95.0|38.76|65.04|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597485|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|15.86|||<|0.001|2-Sided|95.0|7.08|24.63|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597486|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|6.64|||<|0.105|2-Sided|95.0|-1.38|14.67|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597487|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|58.71|||<|0.001|2-Sided|95.0|45.93|71.49|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597488|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|9.27|||<|0.049|2-Sided|95.0|0.04|18.49|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597489|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|42.28|||<|0.001|2-Sided|95.0|28.74|55.82|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597490|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|51.32|||<|0.001|2-Sided|95.0|38.16|64.48|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597491|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|15.3|||<|0.001|2-Sided|95.0|6.39|24.21|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597492|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|6.06|||<|0.147|2-Sided|95.0|-2.13|14.25|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597493|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|57.57|||<|0.001|2-Sided|95.0|44.75|70.39|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597494|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|9.28|||<|0.052|2-Sided|95.0|-0.08|18.64|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597495|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|44.76|||<|0.001|2-Sided|95.0|31.72|57.81|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597496|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|53.79|||<|0.001|2-Sided|95.0|41.08|66.5|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597497|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|15.32|||<|0.001|2-Sided|95.0|6.23|24.41|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597498|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|6.03|||<|0.159|2-Sided|95.0|-2.36|14.43|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597499|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|60.0|||<|0.001|2-Sided|95.0|47.59|72.42|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597500|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|8.18|||<|0.091|2-Sided|95.0|-1.32|17.69|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597501|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|45.93|||<|0.001|2-Sided|95.0|33.21|58.66|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597502|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|53.82|||<|0.001|2-Sided|95.0|41.31|66.32|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597503|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|14.74|||<|0.002|2-Sided|95.0|5.5|23.97|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597504|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|6.58|||<|0.135|2-Sided|95.0|-2.05|15.2|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597505|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|60.61|||<|0.001|2-Sided|95.0|48.37|72.84|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597506|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|1.99|||<|0.694|2-Sided|95.0|-7.91|11.89|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597507|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|49.49|||<|0.001|2-Sided|95.0|37.5|61.47|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597508|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|51.3|||<|0.001|2-Sided|95.0|39.38|63.21|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597509|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|9.0|||<|0.073|2-Sided|95.0|-0.83|19.82|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597510|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|7.01|||<|0.152|2-Sided|95.0|-2.57|16.59|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597511|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|58.46|||<|0.001|2-Sided|95.0|46.88|70.03|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597512|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|1.79|||<|0.734|2-Sided|95.0|-8.56|12.14|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597513|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|49.34|||<|0.001|2-Sided|95.0|38.79|59.89|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597514|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|50.95|||<|0.001|2-Sided|95.0|40.5|61.4|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597515|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|10.43|||<|0.047|2-Sided|95.0|0.15|20.72|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597516|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|8.62|||<|0.094|2-Sided|95.0|-1.46|18.69|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597517|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|59.77|||<|0.001|2-Sided|95.0|49.63|69.9|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597518|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|-5.98|||<|0.266|2-Sided|95.0|-16.51|4.55|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597519|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|48.58|||<|0.001|2-Sided|95.0|39.63|57.54|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597520|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|42.61|||<|0.001|2-Sided|95.0|33.85|51.38|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597521|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|7.16|||<|0.188|2-Sided|95.0|-3.51|17.82|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597522|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|12.99|||<|0.015|2-Sided|95.0|2.5|23.49|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597523|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|55.89|||<|0.001|2-Sided|95.0|47.05|64.73|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597524|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|-8.21|||<|0.05|2-Sided|95.0|-16.4|-0.01|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597525|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|21.96|||<|0.001|2-Sided|95.0|15.64|28.28|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597526|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|13.67|||<|0.001|2-Sided|95.0|8.58|18.77|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597527|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|-0.37|||<|0.934|2-Sided|95.0|-9.18|8.43|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597528|NCT02912650|2935978|Superiority or Other||Cumulative Percentage of Participants wi|7.79|||<|0.056|2-Sided|95.0|-0.19|15.77|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597529|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|21.47|||<|0.001|2-Sided|95.0|15.33|27.62|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597530|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|-1.85|||<|0.078|2-Sided|95.0|-3.9|0.21|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597531|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|1.84|||<|0.079|2-Sided|95.0|-0.21|3.89|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597532|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|-0.68|||<|0.605|2-Sided|95.0|-3.27|1.9|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597533|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|1.16|||<|0.155|2-Sided|95.0|-0.44|2.76|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597534|NCT02912650|2935978|Superiority or Other||CMH adjusted proportions|1.16|||<|0.156|2-Sided|95.0|-0.44|2.75|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597535|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.91||||0.087|2-Sided|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597536|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|43.16|||<|0.001|2-Sided|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597537|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|50.74|||<|0.001|2-Sided|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597538|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|15.12|||<|0.001|2-Sided|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597539|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.23|||<|0.071|2-Sided|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597540|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|58.12|||<|0.001|2-Sided|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597541|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.91|||<|0.087|2-Sided|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597542|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|43.16|||<|0.001|2-Sided|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597543|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|50.74|||<|0.001||95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597544|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|15.12|||<|0.001||95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597545|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.23|||<|0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597546|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|58.12|||<|0.001|2-Sided|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597547|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.91|||<|0.087|2-Sided|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597548|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|43.16|||<|0.001||95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597549|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|50.74|||<|0.001|2-Sided|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597550|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|15.12|||<|0.001|2-Sided|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597551|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.23|||<|0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597552|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|58.12|||<|0.001|2-Sided|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597553|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.91|||<|0.087||95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores|
1597554|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|43.16|||<|0.001|2-Sided|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597555|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|50.74|||<|0.001|2-Sided|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores|
1597556|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|15.12|||<|0.001||95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1598445|NCT02900378|2936704|Other|||||||0.9759|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7|
1597557|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.23|||<|0.071||95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597558|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|58.12|||<|0.001||95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores|
1597559|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.91|||<|0.087||95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597560|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|43.16|||<|0.001||95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597561|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|50.74|||<|0.001||95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597562|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|15.12|||<|0.001|2-Sided|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597563|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.23|||<|0.071|2-Sided|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597564|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|58.12|||<|0.001|2-Sided|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597565|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.91|||<|0.087|2-Sided|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597566|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|43.16|||<|0.001|2-Sided|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597567|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|50.74|||<|0.001|2-Sided|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597568|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|15.12|||<|0.001|2-Sided|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597569|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.23|||<|0.071|2-Sided|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597570|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|58.12|||<|0.001|2-Sided|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597571|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.91|||<|0.087|2-Sided|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597572|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|43.16|||<|0.001|2-Sided|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597573|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|50.74|||<|0.001|2-Sided|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597574|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|15.12|||<|0.001|2-Sided|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597575|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.23|||<|0.071|2-Sided|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597576|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|58.12|||<|0.001|2-Sided|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1620547|NCT02314923|2977569|Other||||||<|0.458|||||||ANOVA||||
1597577|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.91|||<|0.087|2-Sided|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597578|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|43.16|||<|0.001|2-Sided|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597579|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|50.74|||<|0.001|2-Sided|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597580|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|15.12|||<|0.001|2-Sided|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597581|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.23|||<|0.071|2-Sided|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597582|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|58.12|||<|0.001|2-Sided|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597583|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.91|||<|0.087|2-Sided|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597584|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|43.16|||<|0.001|2-Sided|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597585|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|50.74|||<|0.001|2-Sided|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597586|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|15.12|||<|0.001|2-Sided|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597587|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.23|||<|0.071|2-Sided|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597588|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|58.12|||<|0.001|2-Sided|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597589|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.91|||<|0.087|2-Sided|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597590|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|43.16|||<|0.001|2-Sided|95.0|29.56|56.75|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597591|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|50.74|||<|0.001|2-Sided|95.0|37.39|64.09|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597592|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|15.12|||<|0.001|2-Sided|95.0|6.55|23.69|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597593|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.23|||<|0.071|2-Sided|95.0|-0.63|15.1|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597594|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|58.12|||<|0.001|2-Sided|95.0|45.24|71.0|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597595|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.91|||<|0.087|2-Sided|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597596|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|46.74|||<|0.001|2-Sided|95.0|33.5|59.99|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597597|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|54.32|||<|0.001|2-Sided|95.0|41.36|67.29|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597598|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|13.97|||<|0.002|2-Sided|95.0|5.3|22.64|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597599|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|6.08|||<|0.135|2-Sided|95.0|-1.89|14.05|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597600|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|60.51|||<|0.001|2-Sided|95.0|47.99|73.03|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597601|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|7.91|||<|0.087|2-Sided|95.0|-1.15|16.97|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597602|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|46.74|||<|0.001|2-Sided|95.0|33.5|59.99|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597603|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|54.32|||<|0.001|2-Sided|95.0|41.36|67.29|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597604|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|13.37|||<|0.003|2-Sided|95.0|4.65|22.1|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597605|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|5.51|||<|0.179|2-Sided|95.0|-2.52|13.53|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597606|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|59.92|||<|0.001|2-Sided|95.0|47.39|72.46|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597607|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|5.61|||<|0.232|2-Sided|95.0|-3.58|14.8|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597608|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|50.38|||<|0.001|2-Sided|95.0|37.71|63.05|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597609|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|55.66|||<|0.001|2-Sided|95.0|43.11|68.2|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597610|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|9.86|||<|0.032|2-Sided|95.0|0.86|18.86|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597611|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|4.3|||<|0.323|2-Sided|95.0|-4.22|12.81|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597612|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|60.09|||<|0.001|2-Sided|95.0|47.93|72.26|||Cochran-Mantel-Haenszel|||1 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597613|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|4.74|||<|0.374|2-Sided|95.0|-5.7|15.17|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597614|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|41.07|||<|0.001|2-Sided|95.0|28.76|53.38|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597615|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|45.6|||<|0.001|2-Sided|95.0|33.45|57.76|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597616|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|9.86|||<|0.062|2-Sided|95.0|-0.49|20.21|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597617|NCT02912650|2935979|Superiority or Other||Cumulative Percentage of Participants wi|5.16|||<|0.318|2-Sided|95.0|-4.97|15.3|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597618|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|51.08|||<|0.001|2-Sided|95.0|39.53|62.62|||Cochran-Mantel-Haenszel|||0.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597619|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|-0.91|||<|0.849|2-Sided|95.0|-10.2|8.42|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597620|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|17.37|||<|0.001|2-Sided|95.0|7.42|27.31|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597621|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|16.2|||<|0.001|2-Sided|95.0|6.24|26.17|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597622|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|3.62|||<|0.459|2-Sided|95.0|-5.98|13.22|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597623|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|4.52|||<|0.342|2-Sided|95.0|-4.81|13.86|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597624|NCT02912650|2935979|Superiority or Other||CMH adjusted proportions|20.74|||<|0.001|2-Sided|95.0|10.54|30.94|||Cochran-Mantel-Haenszel|||0.25 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597625|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-3.13||||0.545||95.0|-13.26|7.0|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597626|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-8.59||||0.21||95.0|-22.0|4.83|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597627|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-11.32||||0.106|2-Sided|95.0|-25.05|2.4|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597628|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-7.5||||0.152||95.0|-17.76|2.77|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597629|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-4.39||||0.399|2-Sided|95.0|-14.59|5.82|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597630|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-15.68||||0.027||95.0|-29.59|-1.77|||Cochran-Mantel-Haenszel|||12 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores|
1597631|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-6.57||||0.212||95.0|-16.89|3.75|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597632|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-7.99||||0.255||95.0|-21.73|5.76|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores|
1597633|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-14.1||||0.05||95.0|-28.22|0.02|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597634|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-10.38||||0.049||95.0|-20.73|-0.02|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597635|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-3.85||||0.467||95.0|-14.23|6.53|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597636|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-17.9||||0.013||95.0|-32.13|-3.79|||Cochran-Mantel-Haenszel|||11 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores|
1598446|NCT02900378|2936704|Other|||||||0.6461|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6|
1597637|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-11.06||||0.038|2-Sided|95.0|-21.51|-0.61|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597638|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-10.39||||0.14|2-Sided|95.0|-24.19|3.4|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597639|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-20.94||||0.004|2-Sided|95.0|-35.18|-6.69|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597640|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-13.15||||0.013|2-Sided|95.0|-23.57|-2.74|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597641|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-2.22||||0.676|2-Sided|95.0|-12.63|8.19|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597642|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-23.25||||0.001|2-Sided|95.0|-37.31|-9.2|||Cochran-Mantel-Haenszel|||10 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597643|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-13.76||||0.01|2-Sided|95.0|-24.21|-3.31|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597644|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-13.9||||0.051|2-Sided|95.0|-27.84|0.04|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597645|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-27.2|||<|0.001|2-Sided|95.0|-41.44|-12.96|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597646|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-20.7|||<|0.001|2-Sided|95.0|-31.04|-10.35|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597647|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-6.97|||<|0.179|2-Sided|95.0|-17.12|3.19|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597648|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-34.21|||<|0.001|2-Sided|95.0|-48.21|-20.21|||Cochran-Mantel-Haenszel|||9 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597649|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-18.17|||<|0.001|2-Sided|95.0|-28.44|-7.9|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597650|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-18.58|||<|0.01|2-Sided|95.0|-32.64|-4.52|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597651|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-36.26|||<|0.001|2-Sided|95.0|-50.45|-22.07|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597652|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-26.98|||<|0.001|2-Sided|95.0|-36.91|-17.05|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597653|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-8.88|||<|0.064|2-Sided|95.0|-18.27|0.5|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597654|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-45.27|||<|0.001|2-Sided|95.0|-58.96|-31.58|||Cochran-Mantel-Haenszel|||8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597655|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-18.49|||<|0.001|2-Sided|95.0|-28.39|-8.59|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597656|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-25.75|||<|0.001|2-Sided|95.0|-39.93|-11.57|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597657|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-43.78|||<|0.001|2-Sided|95.0|-57.83|-29.72|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597658|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-27.25|||<|0.001|2-Sided|95.0|-36.65|-17.86|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597659|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-8.93|||<|0.042|2-Sided|95.0|-17.53|-0.34|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597660|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-52.9|||<|0.001|2-Sided|95.0|-66.06|-39.75|||Cochran-Mantel-Haenszel|||7 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597661|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-16.94|||<|0.001|2-Sided|95.0|-26.59|-7.29|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597662|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-29.7|||<|0.001|2-Sided|95.0|-43.65|-15.75|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597663|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-46.01|||<|0.001|2-Sided|95.0|-59.98|-32.04|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597664|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-28.06|||<|0.001|2-Sided|95.0|-36.77|-19.35|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597665|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-11.28|||<|0.004|2-Sided|95.0|-18.99|-3.57|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597666|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-57.58|||<|0.001|2-Sided|95.0|-70.44|-44.72|||Cochran-Mantel-Haenszel|||6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597667|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-16.76|||<|0.001|2-Sided|95.0|-26.1|-7.42|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597668|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-31.69|||<|0.001|2-Sided|95.0|-45.61|-17.76|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597669|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-47.74|||<|0.001|2-Sided|95.0|-61.76|-33.72|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597670|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-26.77|||<|0.001|2-Sided|95.0|-35.1|-18.44|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597671|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-10.15|||<|0.005|2-Sided|95.0|-17.24|-3.06|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597672|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-58.14|||<|0.001|2-Sided|95.0|-71.03|-45.26|||Cochran-Mantel-Haenszel|||5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597673|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-11.19|||<|0.013|2-Sided|95.0|-20.02|-2.36|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597674|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-37.18|||<|0.001|2-Sided|95.0|-50.96|-23.4|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597675|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-47.73|||<|0.001|2-Sided|95.0|-61.64|-33.83|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597676|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-20.11|||<|0.001|2-Sided|95.0|-27.97|-12.24|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597677|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-9.0|||<|0.01|2-Sided|95.0|-15.8|-2.19|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597678|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-56.94|||<|0.001|2-Sided|95.0|-69.96|-43.91|||Cochran-Mantel-Haenszel|||4 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597679|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-5.69|||<|0.151|2-Sided|95.0|-13.46|2.08|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597680|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-44.3|||<|0.001|2-Sided|95.0|-58.04|-30.55|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597681|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-49.41|||<|0.001|2-Sided|95.0|-63.21|-35.6|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597682|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-11.7|||<|0.001|2-Sided|95.0|-18.7|-4.7|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597683|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-6.16|||<|0.055|2-Sided|95.0|-12.46|0.13|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597684|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-55.73|||<|0.001|2-Sided|95.0|-68.81|-42.65|||Cochran-Mantel-Haenszel|||3 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597685|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-0.16|||<|0.96|2-Sided|95.0|-6.56|6.23|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597686|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-41.77|||<|0.001|2-Sided|95.0|-55.65|-27.89|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597687|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-41.51|||<|0.001|2-Sided|95.0|-55.51|-27.52|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597688|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-6.23|||<|0.026|2-Sided|95.0|-11.73|-0.73|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597689|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-6.23|||<|0.023|2-Sided|95.0|-11.61|-0.84|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597690|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-47.88|||<|0.001|2-Sided|95.0|-61.18|-34.58|||Cochran-Mantel-Haenszel|||2 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597691|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|0.11|||<|0.968|2-Sided|95.0|-5.2|5.42|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597692|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-32.88|||<|0.001|2-Sided|95.0|-46.22|-19.55|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597693|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-32.52|||<|0.001|2-Sided|95.0|-45.86|-19.17|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597694|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-3.71|||<|0.112|2-Sided|95.0|-8.28|0.86|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597695|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-3.95|||<|0.086|2-Sided|95.0|-8.45|0.56|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597696|NCT02912650|2935980|Superiority or Other||CMH adjusted proportions|-36.56|||<|0.001|2-Sided|95.0|-49.41|-23.71|||Cochran-Mantel-Haenszel|||1.5 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions and the corresponding standard errors, controlling for baseline categorical PSR and gender using table scores.|
1597701|NCT02912650|2935981|Superiority or Other||LS Mean Difference|1.74|||<|0.015|2-Sided|95.0|0.34|3.14|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597702|NCT02912650|2935981|Superiority or Other||LS Mean Difference|6.61|||<|0.001|2-Sided|95.0|4.61|8.62|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597703|NCT02912650|2935981|Superiority or Other||LS Mean Difference|7.87|||<|0.001|2-Sided|95.0|3.27|12.48|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597704|NCT02912650|2935981|Superiority or Other||LS Mean Difference|11.93|||<|0.001|2-Sided|95.0|5.36|18.49|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597705|NCT02912650|2935981|Superiority or Other||LS Mean Difference|19.8|||<|0.001|2-Sided|95.0|13.28|26.31|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597706|NCT02912650|2935981|Superiority or Other||LS Mean Difference|13.17|||<|0.001|2-Sided|95.0|8.55|17.8|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597707|NCT02912650|2935981|Superiority or Other||LS Mean Difference|5.3|||<|0.023|2-Sided|95.0|0.74|9.86|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597708|NCT02912650|2935981|Superiority or Other||LS Mean Difference|25.1|||<|0.001|2-Sided|95.0|18.57|31.63|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597709|NCT02912650|2935981|Superiority or Other||LS Mean Difference|6.43|||<|0.001|2-Sided|95.0|3.3|9.55|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597710|NCT02912650|2935981|Superiority or Other||LS Mean Difference|10.52|||<|0.001|2-Sided|95.0|6.07|14.97|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597711|NCT02912650|2935981|Superiority or Other||LS Mean Difference|16.94|||<|0.001|2-Sided|95.0|12.53|21.36|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597712|NCT02912650|2935981|Superiority or Other||LS Mean Difference|11.43|||<|0.001|2-Sided|95.0|8.29|14.56|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597713|NCT02912650|2935981|Superiority or Other||LS Mean Difference|5.0|||<|0.002|2-Sided|95.0|1.91|8.09|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597714|NCT02912650|2935981|Superiority or Other||LS Mean Difference|21.94|||<|0.001|2-Sided|95.0|17.52|26.37|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597715|NCT02912650|2935981|Superiority or Other||LS Mean Difference|4.94|||<|0.001|2-Sided|95.0|2.62|7.27|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597716|NCT02912650|2935981|Superiority or Other||LS Mean Difference|9.17|||<|0.001|2-Sided|95.0|5.86|12.48|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597717|NCT02912650|2935981|Superiority or Other||LS Mean Difference|14.12|||<|0.001|2-Sided|95.0|10.83|17.4|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597718|NCT02912650|2935981|Superiority or Other||LS Mean Difference|8.81|||<|0.001|2-Sided|95.0|6.48|11.15|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597719|NCT02912650|2935981|Superiority or Other||LS Mean Difference|3.87|||<|0.001|2-Sided|95.0|1.57|6.17|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597720|NCT02912650|2935981|Superiority or Other||LS Mean Difference|17.99|||<|0.001|2-Sided|95.0|14.69|21.28|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597721|NCT02912650|2935981|Superiority or Other||LS Mean Difference|0.38|||<|0.268|2-Sided|95.0|-0.29|1.05|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597722|NCT02912650|2935981|Superiority or Other||LS Mean Difference|3.92|||<|0.001|2-Sided|95.0|2.96|4.88|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597723|NCT02912650|2935981|Superiority or Other||LS Mean Difference|4.3|||<|0.001|2-Sided|95.0|3.35|5.25|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597724|NCT02912650|2935981|Superiority or Other||LS Mean Difference|1.45|||<|0.001|2-Sided|95.0|0.77|2.13|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597725|NCT02912650|2935981|Superiority or Other||LS Mean Difference|1.07|||<|0.002|2-Sided|95.0|0.4|1.74|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597726|NCT02912650|2935981|Superiority or Other||LS Mean Difference|5.37|||<|0.001|2-Sided|95.0|4.42|6.32|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597727|NCT02912650|2935982|Superiority or Other||LS Mean Difference|4.78|||<|0.001|2-Sided|95.0|2.0|7.56|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597728|NCT02912650|2935982|Superiority or Other||LS Mean Difference|6.75|||<|0.001||95.0|2.79|10.71|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597729|NCT02912650|2935982|Superiority or Other||LS Mean Difference|11.52|||<|0.001|2-Sided|95.0|7.59|15.45|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597730|NCT02912650|2935982|Superiority or Other||LS Mean Difference|7.94|||<|0.001|2-Sided|95.0|5.15|10.73|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597731|NCT02912650|2935982|Superiority or Other||LS Mean Difference|3.16|||<|0.024|2-Sided|95.0|0.41|5.91|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597732|NCT02912650|2935982|Superiority or Other||LS Mean Difference|14.68|||<|0.001|2-Sided|95.0|10.74|18.62|||ANOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597733|NCT02912650|2935982|Superiority or Other||LS Mean Difference|3.04|||<|0.001|2-Sided|95.0|1.65|4.43|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597734|NCT02912650|2935982|Superiority or Other||LS Mean Difference|5.44|||<|0.001|2-Sided|95.0|3.46|7.42|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597735|NCT02912650|2935982|Superiority or Other||LS Mean Difference|8.48|||<|0.001|2-Sided|95.0|6.51|10.44|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597736|NCT02912650|2935982|Superiority or Other||LS Mean Difference|5.33|||<|0.001|2-Sided|95.0|3.93|6.73|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597737|NCT02912650|2935982|Superiority or Other||LS Mean Difference|2.29|||<|0.001|2-Sided|95.0|0.91|3.67|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597738|NCT02912650|2935982|Superiority or Other||LS Mean Difference|10.77|||<|0.001|2-Sided|95.0|8.79|12.74|||ANOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597739|NCT02912650|2935982|Superiority or Other||LS Mean Difference|0.23|||<|0.258|2-Sided|95.0|-0.17|0.64|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597740|NCT02912650|2935982|Superiority or Other||LS Mean Difference|2.39|||<|0.001|2-Sided|95.0|1.81|2.96|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597741|NCT02912650|2935982|Superiority or Other||LS Mean Difference|2.62|||<|0.001|2-Sided|95.0|2.05|3.19|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597742|NCT02912650|2935982|Superiority or Other||LS Mean Difference|0.86|||<|0.001|2-Sided|95.0|0.46|1.27|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597743|NCT02912650|2935982|Superiority or Other||LS Mean Difference|0.63|||<|0.002|2-Sided|95.0|0.23|1.03|||ANOVA|||0-2 hour:Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597744|NCT02912650|2935982|Superiority or Other||LS Mean Difference|3.25|||<|0.001|2-Sided|95.0|2.68|3.82|||ANOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597745|NCT02912650|2935983|Superiority or Other||LS Mean Difference|0.99|||<|0.001|2-Sided|95.0|0.41|1.57|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597746|NCT02912650|2935983|Superiority or Other||LS Mean Difference|1.11|||<|0.008|2-Sided|95.0|0.29|1.94|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597747|NCT02912650|2935983|Superiority or Other||LS Mean Difference|2.11|||<|0.001|2-Sided|95.0|1.29|2.92|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597748|NCT02912650|2935983|Superiority or Other||LS Mean Difference|1.66|||<|0.001|2-Sided|95.0|1.07|2.24|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597749|NCT02912650|2935983|Superiority or Other||LS Mean Difference|0.66|||<|0.023|2-Sided|95.0|0.09|1.24|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597750|NCT02912650|2935983|Superiority or Other||LS Mean Difference|2.77|||<|0.001|2-Sided|95.0|1.95|3.59|||ANOVA|||6-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597751|NCT02912650|2935983|Superiority or Other||LS Mean Difference|3.1|||<|0.001|2-Sided|95.0|1.22|4.97|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597752|NCT02912650|2935983|Superiority or Other||LS Mean Difference|5.18|||<|0.001|2-Sided|95.0|2.51|7.86|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597753|NCT02912650|2935983|Superiority or Other||LS Mean Difference|8.28|||<|0.001|2-Sided|95.0|5.62|10.93|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597754|NCT02912650|2935983|Superiority or Other||LS Mean Difference|5.24|||<|0.001|2-Sided|95.0|3.35|7.12|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597755|NCT02912650|2935983|Superiority or Other||LS Mean Difference|2.14|||<|0.024|2-Sided|95.0|0.28|4.0|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597756|NCT02912650|2935983|Superiority or Other||LS Mean Difference|10.42|||<|0.001|2-Sided|95.0|7.76|13.08|||ANOVA|||0-12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597757|NCT02912650|2935983|Superiority or Other||LS Mean Difference|2.49|||<|0.001|2-Sided|95.0|1.21|3.77|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597758|NCT02912650|2935983|Superiority or Other||LS Mean Difference|4.41|||<|0.001|2-Sided|95.0|2.58|6.24|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597759|NCT02912650|2935983|Superiority or Other||LS Mean Difference|6.9|||<|0.001|2-Sided|95.0|5.08|8.71|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597760|NCT02912650|2935983|Superiority or Other||LS Mean Difference|4.48|||<|0.001|2-Sided|95.0|3.2|5.77|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597761|NCT02912650|2935983|Superiority or Other||LS Mean Difference|2.0|||<|0.002|2-Sided|95.0|0.73|3.26|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597762|NCT02912650|2935983|Superiority or Other||LS Mean Difference|8.89|||<|0.001|2-Sided|95.0|7.08|10.71|||ANOVA|||0-8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597763|NCT02912650|2935983|Superiority or Other||LS Mean Difference|1.9|||<|0.001|2-Sided|95.0|0.95|2.86|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597764|NCT02912650|2935983|Superiority or Other||LS Mean Difference|3.73|||<|0.001|2-Sided|95.0|2.37|5.1|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597765|NCT02912650|2935983|Superiority or Other||LS Mean Difference|5.64|||<|0.001|2-Sided|95.0|4.28|6.99|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597766|NCT02912650|2935983|Superiority or Other||LS Mean Difference|3.48|||<|0.001|2-Sided|95.0|2.52|4.45|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597767|NCT02912650|2935983|Superiority or Other||LS Mean Difference|1.58|||<|0.001|2-Sided|95.0|0.63|2.53|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597768|NCT02912650|2935983|Superiority or Other||LS Mean Difference|7.22|||<|0.001|2-Sided|95.0|5.86|8.58|||ANOVA|||0-6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597769|NCT02912650|2935983|Superiority or Other||LS Mean Difference|0.15|||<|0.303|2-Sided|95.0|-0.13|0.43|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597770|NCT02912650|2935983|Superiority or Other||LS Mean Difference|1.53|||<|0.001|2-Sided|95.0|1.14|1.93|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597771|NCT02912650|2935983|Superiority or Other||LS Mean Difference|1.68|||<|0.001|2-Sided|95.0|1.29|2.08|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597772|NCT02912650|2935983|Superiority or Other||LS Mean Difference|0.58|||<|0.001|2-Sided|95.0|0.3|0.86|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597773|NCT02912650|2935983|Superiority or Other||LS Mean Difference|0.44|||<|0.002|2-Sided|95.0|0.16|0.71|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597774|NCT02912650|2935983|Superiority or Other||LS Mean Difference|2.12|||<|0.001|2-Sided|95.0|1.72|2.51|||ANOVA|||0-2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597775|NCT02912650|2935984|Superiority or Other||LS Mean Difference|10.9|||<|0.001|2-Sided|95.0|4.7|17.1|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597776|NCT02912650|2935984|Superiority or Other||LS Mean Difference|18.08|||<|0.001||95.0|9.29|26.88|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597777|NCT02912650|2935984|Superiority or Other||LS Mean Difference|28.98|||<|0.001|2-Sided|95.0|20.26|37.71|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597778|NCT02912650|2935984|Superiority or Other||LS Mean Difference|16.75|||<|0.001|2-Sided|95.0|10.54|22.95|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597779|NCT02912650|2935984|Superiority or Other||LS Mean Difference|5.85|||<|0.06|2-Sided|95.0|-0.25|11.95|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597780|NCT02912650|2935984|Superiority or Other||LS Mean Difference|34.83|||<|0.001|2-Sided|95.0|26.09|43.57|||ANCOVA|||0 to 12 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597781|NCT02912650|2935984|Superiority or Other||LS Mean Difference|6.92|||<|0.001|2-Sided|95.0|3.8|10.04|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597807|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.8||||0.024|2-Sided|95.0|0.11|1.49|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597782|NCT02912650|2935984|Superiority or Other||LS Mean Difference|13.14|||<|0.001|2-Sided|95.0|8.71|17.57|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597783|NCT02912650|2935984|Superiority or Other||LS Mean Difference|20.06|||<|0.001|2-Sided|95.0|15.66|24.45|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597784|NCT02912650|2935984|Superiority or Other||LS Mean Difference|11.36|||<|0.001|2-Sided|95.0|8.23|14.48|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597785|NCT02912650|2935984|Superiority or Other||LS Mean Difference|4.44|||<|0.005|2-Sided|95.0|1.37|7.52|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597786|NCT02912650|2935984|Superiority or Other||LS Mean Difference|24.5|||<|0.001|2-Sided|95.0|20.1|28.9|||ANCOVA|||0 to 6 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597787|NCT02912650|2935984|Superiority or Other||LS Mean Difference|0.58|||<|0.203|2-Sided|95.0|-0.31|1.47|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597788|NCT02912650|2935984|Superiority or Other||LS Mean Difference|5.37|||<|0.001|2-Sided|95.0|4.1|6.63|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597789|NCT02912650|2935984|Superiority or Other||LS Mean Difference|5.94|||<|0.001|2-Sided|95.0|4.69|7.2|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597790|NCT02912650|2935984|Superiority or Other||LS Mean Difference|1.98|||<|0.001|2-Sided|95.0|1.09|2.88|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597791|NCT02912650|2935984|Superiority or Other||LS Mean Difference|1.41|||<|0.002|2-Sided|95.0|0.53|2.28|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597792|NCT02912650|2935984|Superiority or Other||LS Mean Difference|7.35|||<|0.001|2-Sided|95.0|6.09|8.61|||ANCOVA|||0 to 2 hours: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597793|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.24||||0.31|2-Sided|95.0|-0.22|0.71|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597794|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.24||||0.476|2-Sided|95.0|-0.42|0.9|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597795|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.48||||0.151|2-Sided|95.0|-0.18|1.14|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597796|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.22||||0.351|2-Sided|95.0|-0.25|0.69|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597797|NCT02912650|2935985|Superiority or Other||LS Mean Difference|-0.02||||0.937|2-Sided|95.0|-0.48|0.44|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597798|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.46||||0.169|2-Sided|95.0|-0.2|1.12|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597799|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.23||||0.349|2-Sided|95.0|-0.25|0.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597800|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.29||||0.399|2-Sided|95.0|-0.39|0.97|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597801|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.52||||0.131|2-Sided|95.0|-0.15|1.19|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597802|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.31||||0.197|2-Sided|95.0|-0.16|0.79|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597803|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.09||||0.716|2-Sided|95.0|-0.38|0.56|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597804|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.6||||0.078|2-Sided|95.0|-0.07|1.28|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597805|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.37||||0.136|2-Sided|95.0|-0.12|0.86|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597806|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.43||||0.228|2-Sided|95.0|-0.27|1.12|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597808|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.41||||0.099|2-Sided|95.0|-0.08|0.9|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597809|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.04||||0.867|2-Sided|95.0|-0.44|0.52|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597810|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.84||||0.018|2-Sided|95.0|0.15|1.53|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597811|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.61||||0.014|2-Sided|95.0|0.12|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597812|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.45||||0.204|2-Sided|95.0|-0.25|1.14|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597813|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.06||||0.003|2-Sided|95.0|0.37|1.75|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597814|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.8||||0.001|2-Sided|95.0|0.31|1.29|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597815|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.19||||0.438|2-Sided|95.0|-0.29|0.67|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597816|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.25|||<|0.001|2-Sided|95.0|0.56|1.94|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597817|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.6|||<|0.015|2-Sided|95.0|0.12|1.09|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597818|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.62|||<|0.079|2-Sided|95.0|-0.07|1.32|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597819|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.23|||<|0.001|2-Sided|95.0|0.54|1.92|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597820|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.16|||<|0.001|2-Sided|95.0|0.67|1.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597821|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.56|||<|0.024|2-Sided|95.0|0.07|1.04|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597822|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.78|||<|0.001|2-Sided|95.0|1.09|2.47|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597823|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.88|||<|0.001|2-Sided|95.0|0.38|1.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597824|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.72|||<|0.045|2-Sided|95.0|0.02|1.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597825|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.6|||<|0.001|2-Sided|95.0|0.9|2.3|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597826|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.45|||<|0.001|2-Sided|95.0|0.95|1.95|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597827|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.57|||<|0.022|2-Sided|95.0|0.08|1.06|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597828|NCT02912650|2935985|Superiority or Other||LS Mean Difference|2.18|||<|0.001|2-Sided|95.0|1.47|2.88|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597829|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.12|||<|0.001|2-Sided|95.0|0.63|1.61|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597830|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.92|||<|0.01|2-Sided|95.0|0.22|1.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597831|NCT02912650|2935985|Superiority or Other||LS Mean Difference|2.05|||<|0.001|2-Sided|95.0|1.35|2.74|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597832|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.73|||<|0.001|2-Sided|95.0|1.24|2.22|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597833|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.61|||<|0.015|2-Sided|95.0|0.12|1.09|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597834|NCT02912650|2935985|Superiority or Other||LS Mean Difference|2.65|||<|0.001|2-Sided|95.0|1.95|3.35|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597835|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.09|||<|0.001|2-Sided|95.0|0.61|1.56|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598447|NCT02900378|2936704|Other|||||||0.1557|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5|
1597836|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.34|||<|0.001|2-Sided|95.0|0.66|2.03|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597837|NCT02912650|2935985|Superiority or Other||LS Mean Difference|2.43|||<|0.001|2-Sided|95.0|1.75|3.11|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597838|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.85|||<|0.001|2-Sided|95.0|1.37|2.33|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597839|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.76|||<|0.002|2-Sided|95.0|0.29|1.23|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597840|NCT02912650|2935985|Superiority or Other||LS Mean Difference|3.19|||<|0.001|2-Sided|95.0|2.51|3.87|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597841|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.2|||<|0.001|2-Sided|95.0|0.73|1.67|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597842|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.4|||<|0.001|2-Sided|95.0|0.73|2.07|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597843|NCT02912650|2935985|Superiority or Other||LS Mean Difference|2.6|||<|0.001|2-Sided|95.0|1.93|3.26|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597844|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.94|||<|0.001|2-Sided|95.0|1.47|2.41|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597845|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.74|||<|0.002|2-Sided|95.0|0.27|1.2|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597846|NCT02912650|2935985|Superiority or Other||LS Mean Difference|3.33|||<|0.001|2-Sided|95.0|2.67|4.0|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597847|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.15|||<|0.001|2-Sided|95.0|0.69|1.61|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597848|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.59|||<|0.001|2-Sided|95.0|0.94|2.24|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597849|NCT02912650|2935985|Superiority or Other||LS Mean Difference|2.74|||<|0.001|2-Sided|95.0|2.1|3.39|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597850|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.85|||<|0.001|2-Sided|95.0|1.39|2.31|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597851|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.7|||<|0.003|2-Sided|95.0|0.24|1.15|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597852|NCT02912650|2935985|Superiority or Other||LS Mean Difference|3.44|||<|0.001|2-Sided|95.0|2.79|4.09|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597853|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.74|||<|0.001|2-Sided|95.0|0.3|1.19|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597854|NCT02912650|2935985|Superiority or Other||LS Mean Difference|2.15|||<|0.001|2-Sided|95.0|1.52|2.79|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597855|NCT02912650|2935985|Superiority or Other||LS Mean Difference|2.9|||<|0.001|2-Sided|95.0|2.27|3.52|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597856|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.35|||<|0.001|2-Sided|95.0|0.91|1.8|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597857|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.61|||<|0.007|2-Sided|95.0|0.17|1.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597858|NCT02912650|2935985|Superiority or Other||LS Mean Difference|3.5|||<|0.001|2-Sided|95.0|2.88|4.13|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597859|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.32|||<|0.132|2-Sided|95.0|-0.1|0.73|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597860|NCT02912650|2935985|Superiority or Other||LS Mean Difference|2.37|||<|0.001|2-Sided|95.0|1.79|2.96|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597861|NCT02912650|2935985|Superiority or Other||LS Mean Difference|2.69|||<|0.001|2-Sided|95.0|2.11|3.27|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597862|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.98|||<|0.001|2-Sided|95.0|0.57|1.39|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597863|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.66|||<|0.001|2-Sided|95.0|0.26|1.07|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598448|NCT02900378|2936704|Other|||||||0.0301|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4|
1597864|NCT02912650|2935985|Superiority or Other||LS Mean Difference|3.35|||<|0.001|2-Sided|95.0|2.77|3.93|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597865|NCT02912650|2935985|Superiority or Other||LS Mean Difference|-0.08|||<|0.685|2-Sided|95.0|-0.49|0.32|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597866|NCT02912650|2935985|Superiority or Other||LS Mean Difference|2.34|||<|0.001|2-Sided|95.0|1.77|2.91|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597867|NCT02912650|2935985|Superiority or Other||LS Mean Difference|2.26|||<|0.001|2-Sided|95.0|1.69|2.83|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597868|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.55|||<|0.008|2-Sided|95.0|0.14|0.95|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597869|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.63|||<|0.002|2-Sided|95.0|0.23|1.03|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597870|NCT02912650|2935985|Superiority or Other||LS Mean Difference|2.89|||<|0.001|2-Sided|95.0|2.32|3.46|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597871|NCT02912650|2935985|Superiority or Other||LS Mean Difference|-0.22|||<|0.2|2-Sided|95.0|-0.54|0.11|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597872|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.43|||<|0.001|2-Sided|95.0|0.96|1.9|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597873|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.22|||<|0.001|2-Sided|95.0|0.75|1.69|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597874|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.09|||<|0.604|2-Sided|95.0|-0.24|0.42|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597875|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.3|||<|0.069|2-Sided|95.0|-0.02|0.63|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597876|NCT02912650|2935985|Superiority or Other||LS Mean Difference|1.52|||<|0.001|2-Sided|95.0|1.05|1.99|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597877|NCT02912650|2935985|Superiority or Other||LS Mean Difference|-0.21|||<|0.046|2-Sided|95.0|-0.42|0.0|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597878|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.51|||<|0.001|2-Sided|95.0|0.21|0.81|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597879|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.3|||<|0.048|2-Sided|95.0|0.0|0.6|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597880|NCT02912650|2935985|Superiority or Other||LS Mean Difference|-0.04|||<|0.719|2-Sided|95.0|-0.25|0.17|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597881|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.18|||<|0.098|2-Sided|95.0|-0.03|0.38|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597882|NCT02912650|2935985|Superiority or Other||LS Mean Difference|0.48|||<|0.002|2-Sided|95.0|0.18|0.77|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597883|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.13||||0.176|2-Sided|95.0|-0.06|0.32|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597884|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.13||||0.335|2-Sided|95.0|-0.14|0.4|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597885|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.26||||0.054|2-Sided|95.0|0.0|0.53|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597886|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.11||||0.238|2-Sided|95.0|-0.08|0.3|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597887|NCT02912650|2935986|Superiority or Other||LS Mean Difference|-0.02||||0.865||95.0|-0.2|0.17|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597888|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.25||||0.071|2-Sided|95.0|-0.02|0.52|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597889|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.09||||0.364|2-Sided|95.0|-0.1|0.28|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597890|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.18||||0.196|2-Sided|95.0|-0.09|0.45|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597891|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.27||||0.052|2-Sided|95.0|0.0|0.54|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598449|NCT02900378|2936704|Other|||||||0.0094|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3|
1597892|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.14||||0.164|2-Sided|95.0|-0.06|0.33|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597893|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.05||||0.62|2-Sided|95.0|-0.14|0.24|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597894|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.32||||0.022|2-Sided|95.0|0.05|0.59|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597895|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.14||||0.168|2-Sided|95.0|-0.06|0.34|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597896|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.23||||0.114|2-Sided|95.0|-0.05|0.51|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597897|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.37||||0.01|2-Sided|95.0|0.09|0.65|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597898|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.16||||0.104|2-Sided|95.0|-0.03|0.36|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597899|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.03||||0.796|2-Sided|95.0|-0.17|0.22|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597900|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.39||||0.006|2-Sided|95.0|0.11|0.67|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597901|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.25||||0.013|2-Sided|95.0|0.05|0.45|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597902|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.23||||0.106|2-Sided|95.0|-0.05|0.51|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597903|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.48|||<|0.001|2-Sided|95.0|0.2|0.76|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597904|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.34|||<|0.001|2-Sided|95.0|0.14|0.54|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597905|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.09|||<|0.374|2-Sided|95.0|-0.11|0.28|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597906|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.57|||<|0.001|2-Sided|95.0|0.29|0.85|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597907|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.24|||<|0.02|2-Sided|95.0|0.04|0.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597908|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.32|||<|0.027|2-Sided|95.0|0.04|0.61|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597909|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.56|||<|0.001|2-Sided|95.0|0.28|0.84|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597910|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.44|||<|0.001|2-Sided|95.0|0.24|0.64|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597911|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.2|||<|0.045|2-Sided|95.0|0.0|0.4|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597912|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.76|||<|0.001|2-Sided|95.0|0.48|1.05|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597913|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.34|||<|0.001|2-Sided|95.0|0.14|0.55|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597914|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.35|||<|0.018|2-Sided|95.0|0.06|0.65|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597915|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.7|||<|0.001|2-Sided|95.0|0.41|0.99|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597916|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.56|||<|0.001|2-Sided|95.0|0.35|0.76|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597917|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.21|||<|0.041|2-Sided|95.0|0.01|0.42|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597918|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.91|||<|0.001|2-Sided|95.0|0.62|1.2|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597919|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.41|||<|0.001|2-Sided|95.0|0.21|0.61|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597920|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.44|||<|0.003|2-Sided|95.0|0.15|0.73|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597921|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.85|||<|0.001|2-Sided|95.0|0.56|1.13|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597922|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.66|||<|0.001|2-Sided|95.0|0.45|0.86|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597923|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.25|||<|0.014|2-Sided|95.0|0.05|0.45|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597924|NCT02912650|2935986|Superiority or Other||LS Mean Difference|1.1|||<|0.001|2-Sided|95.0|0.81|1.38|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597925|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.41|||<|0.001|2-Sided|95.0|0.21|0.61|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597926|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.58|||<|0.001|2-Sided|95.0|0.29|0.86|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597927|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.98|||<|0.001|2-Sided|95.0|0.7|1.27|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597928|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.71|||<|0.001|2-Sided|95.0|0.51|0.91|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597929|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.3|||<|0.003|2-Sided|95.0|0.1|0.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597930|NCT02912650|2935986|Superiority or Other||LS Mean Difference|1.28|||<|0.001|2-Sided|95.0|1.0|1.57|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597931|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.48|||<|0.001|2-Sided|95.0|0.29|0.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597932|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.56|||<|0.001|2-Sided|95.0|0.28|0.84|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597933|NCT02912650|2935986|Superiority or Other||LS Mean Difference|1.04|||<|0.001|2-Sided|95.0|0.76|1.32|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597934|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.78|||<|0.001|2-Sided|95.0|0.58|0.98|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597935|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.3|||<|0.003|2-Sided|95.0|0.1|0.49|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597936|NCT02912650|2935986|Superiority or Other||LS Mean Difference|1.34|||<|0.001|2-Sided|95.0|1.06|1.61|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597937|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.46|||<|0.001|2-Sided|95.0|0.27|0.65|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597938|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.63|||<|0.001|2-Sided|95.0|0.35|0.9|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597939|NCT02912650|2935986|Superiority or Other||LS Mean Difference|1.09|||<|0.001|2-Sided|95.0|0.82|1.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597940|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.76|||<|0.001|2-Sided|95.0|0.56|0.95|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597941|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.3|||<|0.002|2-Sided|95.0|0.11|0.48|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597942|NCT02912650|2935986|Superiority or Other||LS Mean Difference|1.38|||<|0.001|2-Sided|95.0|1.11|1.65|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597943|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.33|||<|0.001|2-Sided|95.0|0.14|0.51|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597944|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.84|||<|0.001|2-Sided|95.0|0.57|1.11|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597945|NCT02912650|2935986|Superiority or Other||LS Mean Difference|1.17|||<|0.001|2-Sided|95.0|0.9|1.43|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597946|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.56|||<|0.001|2-Sided|95.0|0.38|0.75|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597947|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.24|||<|0.012|2-Sided|95.0|0.05|0.42|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597948|NCT02912650|2935986|Superiority or Other||LS Mean Difference|1.4|||<|0.001|2-Sided|95.0|1.14|1.67|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597949|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.14|||<|0.123|2-Sided|95.0|-0.04|0.31|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597950|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.95|||<|0.001|2-Sided|95.0|0.7|1.2|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597951|NCT02912650|2935986|Superiority or Other||LS Mean Difference|1.09|||<|0.001|2-Sided|95.0|0.84|1.33|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597952|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.41|||<|0.001|2-Sided|95.0|0.23|0.58|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597953|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.27|||<|0.002|2-Sided|95.0|0.1|0.44|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597954|NCT02912650|2935986|Superiority or Other||LS Mean Difference|1.36|||<|0.001|2-Sided|95.0|1.11|1.6|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597955|NCT02912650|2935986|Superiority or Other||LS Mean Difference|-0.07|||<|0.427|2-Sided|95.0|-0.24|0.1|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597956|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.92|||<|0.001|2-Sided|95.0|0.67|1.16|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597957|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.85|||<|0.001|2-Sided|95.0|0.61|1.09|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597958|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.22|||<|0.011|2-Sided|95.0|0.05|0.39|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597959|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.29|||<|0.001|2-Sided|95.0|0.12|0.46|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597960|NCT02912650|2935986|Superiority or Other||LS Mean Difference|1.14|||<|0.001|2-Sided|95.0|0.9|1.38|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597961|NCT02912650|2935986|Superiority or Other||LS Mean Difference|-0.13|||<|0.069|2-Sided|95.0|-0.27|0.01|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597962|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.53|||<|0.001|2-Sided|95.0|0.34|0.73|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597963|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.41|||<|0.001|2-Sided|95.0|0.21|0.6|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597964|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.0|||<|0.977|2-Sided|95.0|-0.14|0.14|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597965|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.13|||<|0.062|2-Sided|95.0|-0.01|0.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597966|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.54|||<|0.001|2-Sided|95.0|0.34|0.73|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597967|NCT02912650|2935986|Superiority or Other||LS Mean Difference|-0.07|||<|0.135|2-Sided|95.0|-0.17|0.02|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597968|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.19|||<|0.006|2-Sided|95.0|0.06|0.32|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597969|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.12|||<|0.084|2-Sided|95.0|-0.02|0.25|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597970|NCT02912650|2935986|Superiority or Other||LS Mean Difference|-0.04|||<|0.386|2-Sided|95.0|-0.14|0.05|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597971|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.03|||<|0.527|2-Sided|95.0|-0.06|0.12|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597972|NCT02912650|2935986|Superiority or Other||LS Mean Difference|0.15|||<|0.031|2-Sided|95.0|0.01|0.28|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597973|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.34||||0.27|2-Sided|95.0|-0.27|0.96|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597974|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.52||||0.239|2-Sided|95.0|-0.35|1.39|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597975|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.87||||0.049|2-Sided|95.0|0.0|1.73|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597976|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.29||||0.352|2-Sided|95.0|-0.32|0.9|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1620548|NCT02314923|2977569|Other||||||<|0.951|||||||ANOVA||||
1597977|NCT02912650|2935987|Superiority or Other||LS Mean Difference|-0.05||||0.862|2-Sided|95.0|-0.66|0.55|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597978|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.81||||0.065|2-Sided|95.0|-0.05|1.68|||ANCOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597979|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.26||||0.408|2-Sided|95.0|-0.36|0.89|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597980|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.64||||0.154||95.0|-0.24|1.53|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597981|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.91||||0.043|2-Sided|95.0|0.03|1.79|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597982|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.32||||0.311|2-Sided|95.0|-0.3|0.95|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597983|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.06||||0.85|2-Sided|95.0|-0.56|0.67|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597984|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.97||||0.032|2-Sided|95.0|0.09|1.85|||ANCOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597985|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.44||||0.179|2-Sided|95.0|-0.2|1.08|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597986|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.73||||0.112|2-Sided|95.0|-0.17|1.64|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597987|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.17||||0.011|2-Sided|95.0|0.27|2.07|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597988|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.49||||0.134|2-Sided|95.0|-0.15|1.13|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597989|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.05||||0.876|2-Sided|95.0|-0.58|0.68|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597990|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.22||||0.008|2-Sided|95.0|0.32|2.12|||ANCOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597991|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.75||||0.022|2-Sided|95.0|0.11|1.39|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597992|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.86||||0.063|2-Sided|95.0|-0.05|1.78|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597993|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.61|||<|0.001|2-Sided|95.0|0.71|2.52|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597994|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.89|||<|0.007|2-Sided|95.0|0.24|1.53|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597995|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.14|||<|0.669|2-Sided|95.0|-0.49|0.77|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597996|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.75|||<|0.001|2-Sided|95.0|0.85|2.66|||ANCOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597997|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.91|||<|0.006|2-Sided|95.0|0.26|1.56|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598089|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.67||||0.002|2-Sided|95.0|0.25|1.09|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1597998|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.01|||<|0.032|2-Sided|95.0|0.09|1.94|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1597999|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.92|||<|0.001|2-Sided|95.0|1.0|2.84|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598000|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.47|||<|0.001|2-Sided|95.0|0.82|2.12|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598001|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.56|||<|0.087|2-Sided|95.0|-0.08|1.2|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598002|NCT02912650|2935987|Superiority or Other||LS Mean Difference|2.48|||<|0.001|2-Sided|95.0|1.56|3.4|||ANCOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598003|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.28|||<|0.001|2-Sided|95.0|0.62|1.94|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598004|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.17|||<|0.015|2-Sided|95.0|0.23|2.1|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598005|NCT02912650|2935987|Superiority or Other||LS Mean Difference|2.44|||<|0.001|2-Sided|95.0|1.52|3.37|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598006|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.93|||<|0.001|2-Sided|95.0|1.27|2.59|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598007|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.65|||<|0.049|2-Sided|95.0|0.0|1.3|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598008|NCT02912650|2935987|Superiority or Other||LS Mean Difference|3.1|||<|0.001|2-Sided|95.0|2.17|4.03|||ANCOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598009|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.56|||<|0.001|2-Sided|95.0|0.91|2.21|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598010|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.49|||<|0.002|2-Sided|95.0|0.57|2.42|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598011|NCT02912650|2935987|Superiority or Other||LS Mean Difference|3.05|||<|0.001|2-Sided|95.0|2.14|3.97|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598012|NCT02912650|2935987|Superiority or Other||LS Mean Difference|2.19|||<|0.001|2-Sided|95.0|1.54|2.84|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598013|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.63|||<|0.055|2-Sided|95.0|-0.01|1.27|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598014|NCT02912650|2935987|Superiority or Other||LS Mean Difference|3.68|||<|0.001|2-Sided|95.0|2.76|4.6|||ANCOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598015|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.55|||<|0.001|2-Sided|95.0|0.92|2.19|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598016|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.91|||<|0.001|2-Sided|95.0|1.0|2.82|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598017|NCT02912650|2935987|Superiority or Other||LS Mean Difference|3.47|||<|0.001|2-Sided|95.0|2.57|4.36|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598018|NCT02912650|2935987|Superiority or Other||LS Mean Difference|2.36|||<|0.001|2-Sided|95.0|1.72|3.0|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598090|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.72|||<|0.001|2-Sided|95.0|0.42|1.02|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598019|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.81|||<|0.012|2-Sided|95.0|0.18|1.44|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598020|NCT02912650|2935987|Superiority or Other||LS Mean Difference|4.27|||<|0.001|2-Sided|95.0|3.37|5.17|||ANCOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598021|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.6|||<|0.001|2-Sided|95.0|0.97|2.22|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598022|NCT02912650|2935987|Superiority or Other||LS Mean Difference|2.11|||<|0.001|2-Sided|95.0|1.23|2.99|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598023|NCT02912650|2935987|Superiority or Other||LS Mean Difference|3.71|||<|0.001|2-Sided|95.0|2.83|4.58|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598024|NCT02912650|2935987|Superiority or Other||LS Mean Difference|2.42|||<|0.001|2-Sided|95.0|1.79|3.04|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598025|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.82|||<|0.009|2-Sided|95.0|0.21|1.43|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598026|NCT02912650|2935987|Superiority or Other||LS Mean Difference|4.53|||<|0.001|2-Sided|95.0|3.65|5.4|||ANCOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598027|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.63|||<|0.001|2-Sided|95.0|1.02|2.23|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598028|NCT02912650|2935987|Superiority or Other||LS Mean Difference|2.26|||<|0.001|2-Sided|95.0|1.4|3.11|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598029|NCT02912650|2935987|Superiority or Other||LS Mean Difference|3.89|||<|0.001|2-Sided|95.0|3.04|4.74|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598030|NCT02912650|2935987|Superiority or Other||LS Mean Difference|2.41|||<|0.001|2-Sided|95.0|1.81|3.01|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598031|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.78|||<|0.01|2-Sided|95.0|0.19|1.38|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598032|NCT02912650|2935987|Superiority or Other||LS Mean Difference|4.67|||<|0.001|2-Sided|95.0|3.82|5.52|||ANCOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598033|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.98|||<|0.001|2-Sided|95.0|0.41|1.56|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598034|NCT02912650|2935987|Superiority or Other||LS Mean Difference|3.08|||<|0.001|2-Sided|95.0|2.26|3.9|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598035|NCT02912650|2935987|Superiority or Other||LS Mean Difference|4.06|||<|0.001|2-Sided|95.0|3.25|4.88|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598036|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.75|||<|0.001|2-Sided|95.0|1.17|2.33|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598037|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.76|||<|0.009|2-Sided|95.0|0.19|1.33|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598038|NCT02912650|2935987|Superiority or Other||LS Mean Difference|4.83|||<|0.001|2-Sided|95.0|4.01|5.64|||ANCOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598039|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.52|||<|0.062|2-Sided|95.0|-0.03|1.06|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598091|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.35|||<|0.018|2-Sided|95.0|0.06|0.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598040|NCT02912650|2935987|Superiority or Other||LS Mean Difference|3.27|||<|0.001|2-Sided|95.0|2.49|4.04|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598041|NCT02912650|2935987|Superiority or Other||LS Mean Difference|3.79|||<|0.001|2-Sided|95.0|3.02|4.56|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598042|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.38|||<|0.001|2-Sided|95.0|0.83|1.93|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598043|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.86|||<|0.002|2-Sided|95.0|0.32|1.4|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598044|NCT02912650|2935987|Superiority or Other||LS Mean Difference|4.65|||<|0.001|2-Sided|95.0|3.88|5.42|||ANCOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598045|NCT02912650|2935987|Superiority or Other||LS Mean Difference|-0.08|||<|0.769|2-Sided|95.0|-0.6|0.44|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598046|NCT02912650|2935987|Superiority or Other||LS Mean Difference|3.13|||<|0.001|2-Sided|95.0|2.39|3.87|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598047|NCT02912650|2935987|Superiority or Other||LS Mean Difference|3.05|||<|0.001|2-Sided|95.0|2.32|3.79|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598048|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.78|||<|0.003|2-Sided|95.0|0.26|1.31|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598049|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.86|||<|0.001|2-Sided|95.0|0.35|1.38|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598050|NCT02912650|2935987|Superiority or Other||LS Mean Difference|3.91|||<|0.001|2-Sided|95.0|3.18|4.65|||ANCOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598051|NCT02912650|2935987|Superiority or Other||LS Mean Difference|-0.3|||<|0.163|2-Sided|95.0|-0.73|0.12|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598052|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.81|||<|0.001|2-Sided|95.0|1.21|2.42|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598053|NCT02912650|2935987|Superiority or Other||LS Mean Difference|1.51|||<|0.001|2-Sided|95.0|0.91|2.11|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598054|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.21|||<|0.33|2-Sided|95.0|-0.21|0.64|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598055|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.51|||<|0.016|2-Sided|95.0|0.1|0.93|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598056|NCT02912650|2935987|Superiority or Other||LS Mean Difference|2.03|||<|0.001|2-Sided|95.0|1.42|2.63|||ANCOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598057|NCT02912650|2935987|Superiority or Other||LS Mean Difference|-0.23|||<|0.076|2-Sided|95.0|-0.49|0.02|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598058|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.69|||<|0.001|2-Sided|95.0|0.33|1.06|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598059|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.46|||<|0.012|2-Sided|95.0|0.1|0.82|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598060|NCT02912650|2935987|Superiority or Other||LS Mean Difference|-0.1|||<|0.457|2-Sided|95.0|-0.35|0.16|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598092|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.02|||<|0.001|2-Sided|95.0|0.6|1.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598061|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.13|||<|0.297|2-Sided|95.0|-0.12|0.39|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598062|NCT02912650|2935987|Superiority or Other||LS Mean Difference|0.59|||<|0.001|2-Sided|95.0|0.23|0.96|||ANCOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598063|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.11||||0.447|2-Sided|95.0|-0.17|0.4|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598064|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.11||||0.6|2-Sided|95.0|-0.3|0.51|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598065|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.22||||0.287|2-Sided|95.0|-0.18|0.62|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598066|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.11||||0.459|2-Sided|95.0|-0.18|0.39|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598067|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.0||||0.986|2-Sided|95.0|-0.28|0.28|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598068|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.22||||0.293|2-Sided|95.0|-0.19|0.62|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598069|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.14||||0.353|2-Sided|95.0|-0.15|0.43|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598070|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.11||||0.599|2-Sided|95.0|-0.3|0.53|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598071|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.25||||0.236|2-Sided|95.0|-0.16|0.66|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598072|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.18||||0.235|2-Sided|95.0|-0.12|0.47|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598073|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.04||||0.79|2-Sided|95.0|-0.25|0.33|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598074|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.29||||0.171|2-Sided|95.0|-0.12|0.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598075|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.23||||0.127|2-Sided|95.0|-0.07|0.53|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598076|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.2||||0.355|2-Sided|95.0|-0.22|0.62|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598077|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.43||||0.045|2-Sided|95.0|0.01|0.85|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598078|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.25||||0.105|2-Sided|95.0|-0.05|0.55|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598079|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.02||||0.918|2-Sided|95.0|-0.28|0.31|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598080|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.45||||0.038|2-Sided|95.0|0.02|0.87|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598081|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.36||||0.019|2-Sided|95.0|0.06|0.66|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598082|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.22||||0.315|2-Sided|95.0|-0.21|0.64|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598083|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.57||||0.008|2-Sided|95.0|0.15|1.0|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598084|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.46||||0.003|2-Sided|95.0|0.16|0.76|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598085|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.1||||0.496|2-Sided|95.0|-0.19|0.4|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598086|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.68||||0.002|2-Sided|95.0|0.26|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598087|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.37||||0.016|2-Sided|95.0|0.07|0.66|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598088|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.3||||0.163|2-Sided|95.0|-0.12|0.72|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598093|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.53|||<|0.001|2-Sided|95.0|0.24|0.83|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598094|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.37|||<|0.089|2-Sided|95.0|-0.06|0.8|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598095|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.9|||<|0.001|2-Sided|95.0|0.48|1.33|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598096|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.9|||<|0.001|2-Sided|95.0|0.6|1.2|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598097|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.36|||<|0.017|2-Sided|95.0|0.07|0.66|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598098|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.27|||<|0.001|2-Sided|95.0|0.84|1.69|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598099|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.72|||<|0.001|2-Sided|95.0|0.42|1.01|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598100|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.48|||<|0.026|2-Sided|95.0|0.06|0.91|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598101|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.2|||<|0.001|2-Sided|95.0|0.78|1.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598102|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.07|||<|0.001|2-Sided|95.0|0.77|1.37|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598103|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.36|||<|0.017|2-Sided|95.0|0.06|0.65|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598104|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.55|||<|0.001|2-Sided|95.0|1.13|1.98|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598105|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.68|||<|0.001|2-Sided|95.0|0.39|0.97|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598106|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.77|||<|0.001|2-Sided|95.0|0.36|1.17|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598107|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.45|||<|0.001|2-Sided|95.0|1.04|1.85|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598108|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.14|||<|0.001|2-Sided|95.0|0.85|1.43|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598109|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.46|||<|0.001|2-Sided|95.0|0.18|0.74|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598110|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.91|||<|0.001|2-Sided|95.0|1.5|2.31|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598111|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.72|||<|0.001|2-Sided|95.0|0.44|1.0|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598112|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.84|||<|0.001|2-Sided|95.0|0.44|1.24|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598113|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.56|||<|0.001|2-Sided|95.0|1.16|1.96|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598114|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.16|||<|0.001|2-Sided|95.0|0.88|1.44|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598115|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.44|||<|0.002|2-Sided|95.0|0.16|0.72|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598116|NCT02912650|2935988|Superiority or Other||LS Mean Difference|2.0|||<|0.001|2-Sided|95.0|1.6|2.4|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598117|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.69|||<|0.001|2-Sided|95.0|0.42|0.96|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598118|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.97|||<|0.001|2-Sided|95.0|0.58|1.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598119|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.66|||<|0.001|2-Sided|95.0|1.27|2.04|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598120|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.09|||<|0.001|2-Sided|95.0|0.82|1.37|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598121|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.4|||<|0.004|2-Sided|95.0|0.13|0.67|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598122|NCT02912650|2935988|Superiority or Other||LS Mean Difference|2.06|||<|0.001|2-Sided|95.0|1.67|2.45|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598123|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.42|||<|0.002|2-Sided|95.0|0.15|0.68|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598124|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.31|||<|0.001|2-Sided|95.0|0.94|1.69|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598125|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.73|||<|0.001|2-Sided|95.0|1.36|2.1|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598126|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.79|||<|0.001|2-Sided|95.0|0.52|1.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598127|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.37|||<|0.005|2-Sided|95.0|0.11|0.63|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598128|NCT02912650|2935988|Superiority or Other||LS Mean Difference|2.1|||<|0.001|2-Sided|95.0|1.73|2.48|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598129|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.18|||<|0.157|2-Sided|95.0|-0.07|0.43|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598130|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.42|||<|0.001|2-Sided|95.0|1.07|1.78|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598131|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.6|||<|0.001|2-Sided|95.0|1.25|1.95|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598132|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.57|||<|0.001|2-Sided|95.0|0.32|0.82|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598133|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.39|||<|0.002|2-Sided|95.0|0.15|0.64|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598134|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.99|||<|0.001|2-Sided|95.0|1.64|2.35|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598135|NCT02912650|2935988|Superiority or Other||LS Mean Difference|-0.01|||<|0.908|2-Sided|95.0|-0.26|0.23|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598136|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.42|||<|0.001|2-Sided|95.0|1.08|1.77|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598137|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.41|||<|0.001|2-Sided|95.0|1.07|1.75|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598138|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.33|||<|0.009|2-Sided|95.0|0.08|0.57|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598139|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.34|||<|0.006|2-Sided|95.0|0.1|0.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598140|NCT02912650|2935988|Superiority or Other||LS Mean Difference|1.75|||<|0.001|2-Sided|95.0|1.4|2.09|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598141|NCT02912650|2935988|Superiority or Other||LS Mean Difference|-0.09|||<|0.406|2-Sided|95.0|-0.29|0.12|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598142|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.9|||<|0.001|2-Sided|95.0|0.61|1.19|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598143|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.81|||<|0.001|2-Sided|95.0|0.52|1.1|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598144|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.09|||<|0.414|2-Sided|95.0|-0.12|0.29|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598145|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.17|||<|0.095|2-Sided|95.0|-0.03|0.37|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598146|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.99|||<|0.001|2-Sided|95.0|0.7|1.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598147|NCT02912650|2935988|Superiority or Other||LS Mean Difference|-0.14|||<|0.04|2-Sided|95.0|-0.28|-0.01|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598148|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.32|||<|0.001|2-Sided|95.0|0.13|0.52|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598149|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.18|||<|0.062|2-Sided|95.0|-0.01|0.37|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598450|NCT02900378|2936704|Other|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2|
1598150|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.0|||<|0.963|2-Sided|95.0|-0.13|0.14|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598151|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.15|||<|0.034|2-Sided|95.0|0.01|0.28|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598152|NCT02912650|2935988|Superiority or Other||LS Mean Difference|0.33|||<|0.001|2-Sided|95.0|0.14|0.52|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598153|NCT02912650|2935989|Superiority or Other|||||||0.887|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598154|NCT02912650|2935989|Superiority or Other||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598155|NCT02912650|2935989|Superiority or Other||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598156|NCT02912650|2935989|Superiority or Other||||||<|0.133|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598157|NCT02912650|2935989|Superiority or Other||||||<|0.088|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598158|NCT02912650|2935989|Superiority or Other||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598159|NCT02912650|2935990|Superiority or Other|||||||0.631|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598160|NCT02912650|2935990|Superiority or Other||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598161|NCT02912650|2935990|Superiority or Other||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598162|NCT02912650|2935990|Superiority or Other||||||<|0.031|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598163|NCT02912650|2935990|Superiority or Other||||||<|0.003|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598164|NCT02912650|2935990|Superiority or Other||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598165|NCT02912650|2935991|Superiority or Other||CMH adjusted proportions|-16.94|||<|0.001|2-Sided|95.0|-26.59|-7.29|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.|
1598166|NCT02912650|2935991|Superiority or Other||CMH adjusted proportions|-29.7|||<|0.001|2-Sided|95.0|-43.65|-15.75|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.|
1598167|NCT02912650|2935991|Superiority or Other||CMH adjusted proportions|-46.01|||<|0.001|2-Sided|95.0|-59.98|-32.04|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.|
1598168|NCT02912650|2935991|Superiority or Other||CMH adjusted proportions|-28.06|||<|0.001|2-Sided|95.0|-36.77|-19.35|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.|
1598169|NCT02912650|2935991|Superiority or Other||CMH adjusted proportions|-11.28|||<|0.004|2-Sided|95.0|-18.99|-3.57|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.|
1598170|NCT02912650|2935991|Superiority or Other||CMH adjusted proportions|-57.58|||<|0.001|2-Sided|95.0|-70.44|-44.72|||Cochran-Mantel-Haenszel|||At 6 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.|
1598171|NCT02912650|2935991|Superiority or Other||CMH adjusted proportions|-18.17|||<|0.001|2-Sided|95.0|-28.44|-7.9|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.|
1598172|NCT02912650|2935991|Superiority or Other||CMH adjusted proportions|-18.58|||<|0.01|2-Sided|95.0|-32.64|-4.52|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.|
1598173|NCT02912650|2935991|Superiority or Other||CMH adjusted proportions|-36.26|||<|0.001|2-Sided|95.0|-50.45|-22.07|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.|
1598174|NCT02912650|2935991|Superiority or Other||CMH adjusted proportions|-26.98|||<|0.001|2-Sided|95.0|-36.91|-17.05|||ANOVA|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.|
1598175|NCT02912650|2935991|Superiority or Other||CMH adjusted proportions|-8.88|||<|0.064|2-Sided|95.0|-18.27|0.5|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on CMH adjusted proportions, controlling for baseline categorical PSR and gender using table scores.|
1598176|NCT02912650|2935991|Superiority or Other||CMH adjusted proportions|-45.27|||<|0.001|2-Sided|95.0|-58.96|-31.58|||Cochran-Mantel-Haenszel|||At 8 hour: Treatment difference and its associated 95% CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions, controlling for baseline categorical PSR and gender using table scores.|
1598178|NCT02912650|2935992|Superiority or Other||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598179|NCT02912650|2935992|Superiority or Other||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598180|NCT02912650|2935992|Superiority or Other||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598181|NCT02912650|2935992|Superiority or Other||||||<|0.069|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598182|NCT02912650|2935992|Superiority or Other||||||<|0.001|||||||Gehan-Wilcoxon test|||p-value was calculated by using Gehan-Wilcoxon test, stratified by gender and baseline categorical PSR terms.|
1598183|NCT02912650|2935993|Superiority or Other||LS Mean Difference|1.62|||<|0.001|2-Sided|95.0|0.76|2.47|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598184|NCT02912650|2935993|Superiority or Other||LS Mean Difference|1.15|||<|0.064|2-Sided|95.0|-0.07|2.37|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598185|NCT02912650|2935993|Superiority or Other||LS Mean Difference|2.77|||<|0.001|2-Sided|95.0|1.56|3.98|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598186|NCT02912650|2935993|Superiority or Other||LS Mean Difference|2.69|||<|0.001|2-Sided|95.0|1.83|3.55|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598187|NCT02912650|2935993|Superiority or Other||LS Mean Difference|1.07|||<|0.013|2-Sided|95.0|0.23|1.92|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598188|NCT02912650|2935993|Superiority or Other||LS Mean Difference|3.84|||<|0.001|2-Sided|95.0|2.63|5.05|||ANOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598189|NCT02912650|2935993|Superiority or Other||LS Mean Difference|3.94|||<|0.001|2-Sided|95.0|2.06|5.81|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598190|NCT02912650|2935993|Superiority or Other||LS Mean Difference|6.11|||<|0.001|2-Sided|95.0|3.44|8.78|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598191|NCT02912650|2935993|Superiority or Other||LS Mean Difference|10.05|||<|0.001|2-Sided|95.0|7.39|12.7|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598192|NCT02912650|2935993|Superiority or Other||LS Mean Difference|6.94|||<|0.001|2-Sided|95.0|5.06|8.83|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598193|NCT02912650|2935993|Superiority or Other||LS Mean Difference|3.01|||<|0.002|2-Sided|95.0|1.15|4.86|||ANOVA|||0 to 8 hours: Treatment difference and 95% CI were based on LS Mean from ANOVA with treatment, gender and baseline categorical PSR.|
1598194|NCT02912650|2935993|Superiority or Other||LS Mean Difference|13.05|||<|0.001|2-Sided|95.0|10.39|15.71|||ANOVA|||0-8 hours: Treatment difference and 95% CI were based on LS Mean from analysis of variance (ANOVA) with treatment, gender and baseline categorical PSR.|
1598195|NCT02912650|2935994|Superiority or Other||LS Mean Difference|3.75|||<|0.001|2-Sided|95.0|1.85|5.64|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598196|NCT02912650|2935994|Superiority or Other||LS Mean Difference|3.67|||<|0.008|2-Sided|95.0|0.98|6.36|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598197|NCT02912650|2935994|Superiority or Other||LS Mean Difference|7.42|||<|0.001|2-Sided|95.0|4.75|10.09|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598198|NCT02912650|2935994|Superiority or Other||LS Mean Difference|5.59|||<|0.001|2-Sided|95.0|3.69|7.49|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598199|NCT02912650|2935994|Superiority or Other||LS Mean Difference|1.84|||<|0.053|2-Sided|95.0|-0.03|3.71|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598200|NCT02912650|2935994|Superiority or Other||LS Mean Difference|9.26|||<|0.001|2-Sided|95.0|6.59|11.94|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598201|NCT02912650|2935995|Superiority or Other||LS Mean Difference|9.1|||<|0.001|2-Sided|95.0|4.9|13.31|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598202|NCT02912650|2935995|Superiority or Other||LS Mean Difference|15.32|||<|0.001|2-Sided|95.0|9.35|21.29|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598203|NCT02912650|2935995|Superiority or Other||LS Mean Difference|24.42|||<|0.001|2-Sided|95.0|18.5|30.35|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598451|NCT02900378|2936704|Other|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1|
1598204|NCT02912650|2935995|Superiority or Other||LS Mean Difference|14.76|||<|0.001|2-Sided|95.0|10.55|18.97|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598205|NCT02912650|2935995|Superiority or Other||LS Mean Difference|5.66|||<|0.008|2-Sided|95.0|1.51|9.8|||ANCOVA|||Treatment difference and 95% CI were based on LS Mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1598206|NCT02912650|2935995|Superiority or Other||Least Squares (LS) Mean Difference|30.08|||<|0.001|2-Sided|95.0|24.14|36.02|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.|
1598207|NCT02912468|2936026|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-21.12|||<|0.0001|2-Sided|95.0|-25.17|-17.06||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598208|NCT02912468|2936027|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-1.12|||<|0.0001|2-Sided|95.0|-1.31|-0.93||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598209|NCT02912468|2936028|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|10.56|||<|0.0001|2-Sided|95.0|8.79|12.34||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598210|NCT02912468|2936029|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.61|||<|0.0001|2-Sided|95.0|-3.04|-2.17||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598211|NCT02912468|2936030|Superiority|Hierarchical testing procedure was used to control type I error. For regions outside of Japan, this first secondary endpoint was not tested unless both co-primary endpoints were significant at the 0.05 level. Hierarchical testing continued only when previous endpoint was statistically significant. For Japan submission, LMK was instead a co-primary endpoint which also had to be met before secondary endpoints were tested in the hierarchy. Last endpoint in hierarchy is Week 24 SNOT-22.|LS mean difference|-7.44|||<|0.0001|2-Sided|95.0|-8.35|-6.53||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598212|NCT02912468|2936031|Superiority||LS mean difference|-2.06|||<|0.0001|2-Sided|95.0|-2.43|-1.69|||ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin’s rule.|
1598213|NCT02912468|2936032|Superiority||LS mean difference|-0.89|||<|0.0001|2-Sided|95.0|-1.07|-0.71|||ANCOVA|||Data were analyzed using a hybrid method of the worst-observation carried forward (WOCF) and multiple imputation (MI). The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin’s rule.|
1598214|NCT02912364|2936036|Other||Mean Difference (Final Values)|0.54|||<|0.001|2-Sided|95.0|0.3|0.79|||t-test, 2 sided|Degrees of freedom = 22.|||
1598215|NCT02912364|2936037|Other||Mean Difference (Final Values)|0.23|||<|0.001|2-Sided|95.0|0.13|0.34|||t-test, 2 sided|degrees of freedom = 22|||
1598216|NCT02911948|2936080|Superiority|Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was strictly below 0.0% for null hypothesis (H0): D=0.0% against the alternative (HA): D≠0.0%, where D is the mean difference (IDegLira - IDeg).|Treatment contrast|-1.28|||<|0.0001|2-Sided|95.0|-1.5|-1.06|||ANCOVA|||The response and change from baseline in response after 26 weeks are analysed using an ANCOVA model with treatment and pre-trial anti-diabetic treatment as fixed factors and corresponding baseline HbA1c value as covariate.|
1598217|NCT02911519|2936158|Superiority||Slope|0.01||||0.97|2-Sided|95.0|-0.19|0.19|||Mixed Models Analysis||This is an intention to treat analysis.||
1598218|NCT02911519|2936159|Superiority|This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row.|Slope|-0.01||||0.19|2-Sided|95.0|-0.02|0.01|||Mixed Models Analysis||This is an intention to treat analysis. This analysis applies to SSFB subjective domain in the second row.||
1598219|NCT02911519|2936159|Superiority|This analysis applies to SSFB objective domain in the first row.|Slope|-0.01||||0.33|2-Sided|95.0|-0.01|0.01|||Mixed Models Analysis||This is an intention to treat analysis. This analysis applies to SSFB objective domain in the first row.||
1598220|NCT02911519|2936160|Superiority|This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row.|Slope|0.19||||0.27|2-Sided|95.0|-0.15|0.53|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 4TH DOMAIN (environment) in the fourth row.||
1598221|NCT02911519|2936160|Superiority|This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row.|Slope|0.16||||0.52|2-Sided|95.0|-0.33|0.65|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 3RD DOMAIN (social relationships) in the third row.||
1598222|NCT02911519|2936160|Superiority|This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row.|Slope|-0.04||||0.81|2-Sided|95.0|-0.38|0.29|||Mixed Models Analysis||This is an intention to treat analysis.This statistical Analysis applies to WHOQOL-BREF 2ND DOMAIN (psychological) in the second row.||
1598223|NCT02911519|2936160|Superiority|This statistical Analysis applies to WHOQOL-BREF 1ST DOMAIN (physical health) in the first row.|Slope|0.04||||0.81|2-Sided|95.0|-0.38|0.3|||Mixed Models Analysis||This is an intention to treat analysis. This statistical Analysis applies to WHOQOL-BREF 1ST DOMAIN (physical health) in the first row.||
1598224|NCT02911519|2936161|Superiority||Slope|0.03||||0.61|2-Sided|95.0|-0.1|0.17|||Mixed Models Analysis||This is an intention to treat analysis.||
1598225|NCT02911519|2936163|Superiority||Slope|-0.19||||0.3|2-Sided|95.0|-0.57|0.18|||Mixed Models Analysis||This is intention-to-treat analysis.||
1598226|NCT02911519|2936163|Superiority||Slope|0.01||||0.94|2-Sided|95.0|-0.36|0.39|||Mixed Models Analysis||This is intention-to-treat analysis.||
1598227|NCT02911519|2936164|Superiority||Risk Ratio (RR)|0.98||||0.73|2-Sided|95.0|0.87|1.1|||Mixed Models Analysis||The Brief Group Psychoeducation is the numerator and the group of Treatment as Usual Only is the denominator for relative risk. This is intention-to-treat analysis.||
1598228|NCT02911519|2936165|Superiority||Risk Ratio (RR)|0.95||||0.59|2-Sided|95.0|0.77|1.16|||Mixed Models Analysis||This is intention-to-treat analysis. The Brief Group Psychoeducation is the numerator and the group of Treatment as Usual Only is the denominator for relative risk.||
1598229|NCT02910739|2936174|Other||GMR|1.08|||||2-Sided|90.0|0.9|1.3|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on C24hr; no hypothesis testing was planned for this outcome measure.|
1598230|NCT02910739|2936175|Other||GMR|1.01|||||2-Sided|90.0|0.8|1.27|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-24hr; no hypothesis testing was planned for this outcome measure.|
1598231|NCT02910739|2936176|Other||GMR|1.04|||||2-Sided|90.0|0.82|1.31|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-last; no hypothesis testing was planned for this outcome measure.|
1598232|NCT02910739|2936177|Other||GMR|1.07|||||2-Sided|90.0|0.77|1.5|||||GMR = GLSM for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on Cmax; no hypothesis testing was planned for this outcome measure.|
1598233|NCT02910739|2936178|Other|The pharmacokinetic condition to initiate Part 2 of the study would be met if the point estimate for the AUC0-∞ ratio of geometric means (participants with moderate HI / healthy matched control participants) exceeds 1.5.|Geometric least-squares mean ratio (GMR)|1.04|||||2-Sided|90.0|0.83|1.3|||||GMR = geometric least squares mean (GLSM) for moderate HI participants / GLSM for healthy participants.|Per study protocol, the purpose of this analysis is only to estimate the effect of moderate HI on AUC0-∞; no hypothesis testing was planned for this outcome measure.|
1598234|NCT02910713|2936179|Superiority||Least Squares Mean Difference|-0.6|Standard Error of the Mean|0.101|<|0.0001|2-Sided|95.0|-0.8|-0.4||One-sided p-value for the difference between Intranasal and Extranasal.|ANOVA||||
1598235|NCT02910713|2936180|Superiority||Least Squares Mean Difference|-13.36|Standard Error of the Mean|1.999|<|0.0001|2-Sided|95.0|-17.31|-9.4||One-sided p-value for the difference between Intranasal and Extranasal.|ANOVA||||
1598236|NCT02910102|2936187|Superiority||Mean Difference (Final Values)|-0.17||||0.922|2-Sided|95.0|-3.73|3.38||The threshold for statistical significance was p=0.05|Mixed Models Analysis|Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.|||
1598237|NCT02910102|2936188|Superiority||Mean Difference (Final Values)|-1.9||||0.3565|2-Sided|95.0|-6.04|2.23||The threshold for statistical significance was p=0.05|Mixed Models Analysis|Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.|||
1598238|NCT02910089|2936189|Other|As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|Odds Ratio (OR)|0.91|||||2-Sided|95.0|0.71|1.17|||||||
1598239|NCT02910089|2936190|Superiority||Odds Ratio (OR)|1.03|||||2-Sided|95.0|0.83|1.28|||||||
1598240|NCT02910089|2936191|Other||Mean Difference (Final Values)|1.0|||||2-Sided|95.0|-2.42|4.4|||||Model-based Mean Differences are reported that have been adjusted for imbalanced baseline characteristics|Average of the percentage (proportion x 100) of days covered across all subjects.|
1598241|NCT02910089|2936192|Superiority|As per the SAP, no p-values were computed. Only point estimates with 95% confidence intervals were evaluated.|Mean Difference (Final Values)|0.06|||||2-Sided|95.0|-0.2|0.32|||||Model-based Mean Differences are reported that have been adjusted for imbalanced baseline characteristics||
1598242|NCT02909959|2936238|Equivalence|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|-2.72|Standard Error of the Mean|3.05||0.373|2-Sided|||||The test was considered statistically significant if the p-value < 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.|
1598261|NCT02908620|2936306|Superiority||Mean Difference (Final Values)|4.1|Standard Error of the Mean|4.92||0.442|2-Sided|95.0|-6.48|14.62|||ANOVA||Least squares mean (marginal mean)||
1598262|NCT02908620|2936307|Superiority||Mean Difference (Final Values)|-8.7|Standard Error of the Mean|5.48||0.134|2-Sided|95.0|-20.38|2.99|||ANOVA||Least squares mean (marginal mean)||
1598452|NCT02900378|2936705|Other|||||||0.3212|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12|
1598243|NCT02909959|2936239|Equivalence|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|-2.32|Standard Error of the Mean|3.01||0.442|2-Sided|||||The test was considered statistically significant if the p-value < 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.|
1598244|NCT02909959|2936240|Equivalence|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|0.774|Standard Error of the Mean|2.99||0.797|2-Sided|||||The test was considered statistically significant if the p-value < 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.|
1598245|NCT02909959|2936241|Equivalence|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|0.08|Standard Error of the Mean|2.99||0.98|2-Sided|||||The test was considered statistically significant if the p-value < 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.|
1598246|NCT02909959|2936242|Equivalence|Statistical significance was measured at the 0.05 alpha level for a two-sided test, so the rejection region for a normally distributed T-score was +/-1.96*SE(Diff), where SE(Diff) is the estimated standard error of the difference between the LS mean of sulforaphane and LS mean of the placebo group.|Mean Difference (Final Values)|-2.96|Standard Error of the Mean|3.03||0.331|2-Sided|||||The test was considered statistically significant if the p-value < 0.05.|Mixed Models Analysis|Mixed-effects model with random intercept and unstructured covariance matrix from baseline to week 16.|This analysis compares LS Mean Sulforaphane - LS Mean Placebo.|The null hypothesis is that the least-square mean of sulforaphane's SRS-2 T-score minus the least-square mean of placebo group's T-score is 0.|
1598247|NCT02909764|2936252|Other|T-tests were conducted to determine whether differences in baseline blood pressure between groups|||||>|0.4|||||||t-test, 2 sided|||T-tests were conducted to determine whether differences in baseline blood pressure between the two groups.|
1598248|NCT02909764|2936253|Other|General estimating equations (GEE)|||||<|0.05|||||||GEE|||Generalized estimating equations (GEE) were conducted on the amount of cereal in grams ingested during 28 days home-exposure period. The GEE approach accounts for the repeated measurements of outcomes over time for each child and examines whether the slopes of the lines created differ between the treatment groups.|
1598249|NCT02909764|2936254|Other|||||||0.77|||||||ANOVA||||
1598250|NCT02909764|2936255|Other|||||||0.32|||||||ANOVA||||
1598251|NCT02909764|2936256|Other|Yates’s chi-square analyses were used to determine which of the two cereals children in each group preferred at baseline and after the 8-week exposure period, and whether the number of children who shifted preference from the regular cereal at baseline to the low salt cereal after the exposure period differed between groups.|||||<|0.05|||||||Chi-squared|||Yates’s chi-square analyses were used to determine which of the two cereals children in each group preferred at baseline and after the 8-week exposure period, and whether the number of children who shifted preference from the regular cereal at baseline to the low salt cereal after the exposure period differed between groups.|
1598252|NCT02909764|2936257|Other|||||||0.3|||||||ANOVA||||
1598253|NCT02909101|2936287|Superiority|||||||0.133|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.|
1598254|NCT02909101|2936288|Superiority|||||||0.025|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.|
1598255|NCT02909101|2936289|Superiority|||||||0.337|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.|
1598256|NCT02909101|2936290|Other|||||||0.719|||||||t-test, 2 sided|||To determine acceptability in terms of helpfulness, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.|
1598257|NCT02909101|2936291|Other|||||||0.744|||||||t-test, 2 sided|||To determine acceptability, we examined whether mean ratings for both arms were above 3.5, and we also examined whether there was any difference between arms.|
1598258|NCT02909101|2936292|Superiority|||||||0.054|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.|
1598259|NCT02909101|2936293|Superiority|||||||0.039|||||||ANCOVA|ANCOVAs were 2 (Arm) by 2 (Time). Covariates were age, WTAR standard score, and number of games improved (as a proxy of intervention engagement).||Estimated marginal means, adjusted for covariates in the model, are reported. The p-value reported is for the Arm by Time interaction effect.|
1598260|NCT02908620|2936305|Superiority||Mean Difference (Final Values)|6.8|Standard Error of the Mean|4.78||0.172|2-Sided|95.0|-3.27|16.9|||ANOVA||Least squares mean (marginal mean)||
1598263|NCT02908620|2936308|Superiority||Mean Difference (Final Values)|2.8|Standard Error of the Mean|2.74||0.322|2-Sided|95.0|-3.06|8.69|||ANOVA||Least squares mean (marginal mean)||
1598264|NCT02908529|2936310|Superiority||Median Difference (Final Values)|-15.9|||<|0.001|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1598265|NCT02908347|2936323|Superiority|||||||1|||||||Fisher Exact|||PASI 50 - Day 43|
1598266|NCT02908347|2936323|Superiority|||||||0.5136|||||||Fisher Exact|||PASI 30 - Day 43|
1598267|NCT02908347|2936323|Superiority|||||||1|||||||Fisher Exact|||PASI 50 - Day 29|
1598268|NCT02908347|2936323|Superiority|||||||1|||||||Fisher Exact|||PASI 30 - Day 29|
1598269|NCT02908347|2936326|Superiority||Median Difference (Final Values)|0.64||||0.8785|2-Sided|95.0|-2.09|3.36|||Wilcoxon (Mann-Whitney)||||
1598270|NCT02908178|2936343|Other||Hazard Ratio (HR)|1.17||||0.62|2-Sided|99.0|0.81|1.69||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and treated recurrence in the Aim 2 matched cohort.|
1598271|NCT02908178|2936344|Other||Hazard Ratio (HR)|1.03||||0.603|2-Sided|99.0|0.71|1.51||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and ipsilateral invasive breast cancer occurrence for the Aim 2 matched cohort.|
1598272|NCT02908178|2936345|Other||Hazard Ratio (HR)|1.13||||0.861|2-Sided|99.0|0.54|2.35||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between between use of sentinel lymph node biopsy (SLNB) and breast cancer specific mortality.|
1598273|NCT02908178|2936346|Other||Hazard Ratio (HR)|1.1||||0.029|2-Sided|99.0|0.98|1.25||P-value is unadjusted. Threshold for statistical significance is 0.01|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 2 matched cohort.|
1598274|NCT02908178|2936346|Other||Hazard Ratio (HR)|1.21||||0.01|2-Sided|99.0|0.93|1.58||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 2 matched cohort.|
1598275|NCT02908178|2936346|Other||Hazard Ratio (HR)|0.98||||0.113|2-Sided|99.0|0.87|1.1||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any infection in the Aim 2 matched cohort.|
1598276|NCT02908178|2936346|Other||Hazard Ratio (HR)|1.53|||<|0.001|2-Sided|99.0|1.12|2.11||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema related complications in the Aim 2 matched cohort.|
1598277|NCT02908178|2936346|Other||Hazard Ratio (HR)|1.09|||<|0.207|2-Sided|99.0|1.0|1.2||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any side effects in the matched Aim 2 cohort.|
1598278|NCT02908178|2936347|Other||Hazard Ratio (HR)|0.88|||<|0.001|2-Sided|99.0|0.73|1.05||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Estimates are from matched cohort and adjusted for physician visits, any hospitalization in the 3-24 months prior to DCIS diagnosis, use of preoperative breast MRI, surgeon's operation volume, and receipt of radiation therapy.|Testing the association between use of sentinel lymph node biopsy (SLNB) and overall mortality in the Aim 2 matched cohort.|
1598279|NCT02908178|2936348|Other|||||||0.48||||||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared|||Testing the association between receipt of SLNB and receipt of radiation therapy within 9 months of DCIS diagnosis.|
1598280|NCT02908178|2936349|Other||||||<|0.001||||||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared|||Testing the association between receipt of SLNB and receipt of mastectomy within 6 months of DCIS diagnosis.|
1598281|NCT02908178|2936350|Other||Odds Ratio (OR)|1.31||||0.003|2-Sided|99.0|1.04|1.65||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and pain in the Aim 1 matched cohort.|
1598282|NCT02908178|2936350|Other||Odds Ratio (OR)|1.4|||<|0.001|2-Sided|99.0|1.03|1.91||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and seroma in the Aim 1 matched cohort.|
1598453|NCT02900378|2936705|Other|||||||0.5463|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10|
1598283|NCT02908178|2936350|Other||Odds Ratio (OR)|1.24|||<|0.001|2-Sided|99.0|1.0|1.54||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and wound infection in the Aim 1 matched cohort.|
1598284|NCT02908178|2936350|Other||Odds Ratio (OR)|4.45|||<|0.001|2-Sided|99.0|2.27|8.75||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status|Testing the association between use of sentinel lymph node biopsy (SLNB) and lymphedema in the Aim 1 matched cohort.|
1598285|NCT02908178|2936350|Other||Odds Ratio (OR)|1.39|||<|0.001|2-Sided|99.0|1.18|1.63||P-value is unadjusted. Threshold for statistical significance is 0.01.|Chi-squared||Reference is no SLNB. Odds ratio accounts for matching and adjusted for subsequent mastectomy within 180 days after initial BCS, prior MRI, and radiation therapy status.|Testing the association between use of sentinel lymph node biopsy (SLNB) and any complication in the Aim 1 matched cohort.|
1598286|NCT02907489|2936404|Superiority|||||||0.01||||||0.01 for S3 Significant at P ≤ 0.05|Chi-squared||||
1598287|NCT02907489|2936404|Superiority|||||||0.467||||||0.467 for S2, Significant at P ≤ 0.05|Chi-squared||||
1598288|NCT02907489|2936404|Superiority|||||||0.982||||||0.982 for S1, Significant at P ≤ 0.05|Chi-squared||||
1598289|NCT02907489|2936405|Superiority|||||||0.063||||||0.063 for 72 hours, Significant at P ≤ 0.05|Chi-squared||||
1598290|NCT02907489|2936405|Superiority|||||||0.041||||||0.041 for 48 hours, Significant at P ≤ 0.05|Chi-squared||||
1598291|NCT02907489|2936405|Superiority|||||||0.083||||||0.083 for 24 hours, Significant at P ≤ 0.05|Chi-squared||||
1598292|NCT02907268|2936428|Equivalence|Each variable compared with the “no change” score. The “no change” score is 0 for wrinkles-related variables.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1598293|NCT02907268|2936429|Equivalence|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1598294|NCT02907268|2936430|Equivalence|"Each variable compared with the no change score. The no change score is 0 for wrinkles-related variables."|||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1598295|NCT02907216|2936442|Non-Inferiority|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 3 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.81|||||2-Sided|95.0|-2.04|4.47|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 3 seroprotective titres ≥ 8 ED50.|
1598296|NCT02907216|2936442|Non-Inferiority|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 2 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.0|||||2-Sided|95.0|-2.92|2.95|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 2 seroprotective titres ≥ 8 ED50.|
1598297|NCT02907216|2936442|Non-Inferiority|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective titers ≥ 8 ED50 for anti-polio 1 antibodies should be ≥ -10%.|Difference in seroprotective titer|0.0|||||2-Sided|95.0|-2.68|2.74|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-polio 1 seroprotective titres ≥ 8 ED50.|
1598298|NCT02907216|2936443|Non-Inferiority|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 10 IU/mL for anti-FHA antibodies should be ≥ -10%.|Difference-Seroprotective concentration|0.0|||||2-Sided|95.0|-2.66|2.72|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-FHA antibody concentration ≥ 10 IU/mL.|
1598299|NCT02907216|2936443|Non-Inferiority|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 10 IU/mL for anti-PT antibodies should be ≥ -10%.|Difference-Seroprotective concentration|2.99|||||2-Sided|95.0|-2.7|9.12|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-PT antibody concentration ≥ 10 IU/mL.|
1598300|NCT02907216|2936444|Non-Inferiority|Criteria for non-inferiority: The LL of the standardised asymptotic 95% CI on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 0.1 IU/mL for anti-T antibodies should be ≥ -10%.|Difference-Seroprotective concentration|-0.69|||||2-Sided|95.0|-4.39|2.71|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-T antibody concentration ≥ 0.1 IU/mL.|
1598333|NCT02906709|2936526|Superiority||Difference in the Least Squares Means|-0.9|||<|0.001|2-Sided|95.0|-1.15|-0.66|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior anti-hyperglycemic agent (AHA) therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.
1598301|NCT02907216|2936444|Non-Inferiority|Criteria for non-inferiority: The Lower Limit (LL) of the standardised asymptotic 95% Confidence Interval (CI) on the difference (Co-administration Group minus Staggered Group) in the percentage of subjects with seroprotective concentrations ≥ 0.1 IU/mL for anti-D antibodies should be ≥ -10%.|Difference-Seroprotective concentration|0.0|||||2-Sided|95.0|-2.66|2.74|||||The 2-sided asymptotic standardised 95% CIs for the difference between groups in terms of percentage of subjects with antibody concentration ≥ to the pre-defined cut-off.|Difference between Co-administration Group minus Staggered Group in terms of percentage of subjects with anti-D antibody concentration ≥ 0.1 IU/mL.|
1598302|NCT02906930|2936469|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.06||||0.0001|2-Sided|95.0|0.01|0.26||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 14 mg /Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1598303|NCT02906930|2936469|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.13||||0.0001|2-Sided|95.0|0.04|0.36||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 7 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1598304|NCT02906930|2936469|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.48||||0.03|2-Sided|95.0|0.25|0.93||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide 3 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1598305|NCT02906930|2936470|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.33||||0.0002|2-Sided|95.0|0.19|0.6||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1598306|NCT02906930|2936470|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.33||||0.0002|2-Sided|95.0|0.18|0.59||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 7 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1598307|NCT02906930|2936470|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.45||||0.0043|2-Sided|95.0|0.26|0.78||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox||Oral Semaglutide 3 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1598308|NCT02906930|2936493|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-2.6|||<|0.0001|2-Sided|95.0|-3.4|-1.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1598309|NCT02906930|2936493|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.0|||<|0.0138|2-Sided|95.0|-1.8|-0.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 7 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1598310|NCT02906930|2936493|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-0.2|||<|0.7075|2-Sided|95.0|-1.0|0.6|||MMRM||Oral Semaglutide 3 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1598334|NCT02905331|2936614|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1598335|NCT02905331|2936619|Superiority||||||<|0.001|||||||Fisher Exact||||
1598336|NCT02905331|2936620|Superiority||||||<|0.001|||||||Fisher Exact||||
1598337|NCT02905266|2936625|Superiority||Odds Ratio (OR)|13.2|||||2-Sided|95.0|-6.1|32.6|||||||
1598338|NCT02905266|2936625|Superiority||Odds Ratio (OR)|1.72|||||2-Sided|95.0|0.79|3.75|||||||
1598339|NCT02905266|2936626|Superiority||Odds Ratio (OR)|13.2|||||2-Sided|95.0|-5.6|32.0|||||||
1598340|NCT02905266|2936626|Superiority||Odds Ratio (OR)|1.77|||||2-Sided|95.0|0.8|3.94|||||||
1598454|NCT02900378|2936705|Other|||||||0.5865|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8|
1598311|NCT02906930|2936493|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.1|||<|0.8692|2-Sided|95.0|-0.9|0.8||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1598312|NCT02906930|2936493|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0866|2-Sided|95.0|-1.9|0.1||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1598313|NCT02906930|2936493|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.3|||<|0.0001|2-Sided|95.0|-3.1|-1.5||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1598314|NCT02906930|2936494|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.4|||<|0.0001|2-Sided|95.0|-1.7|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 14 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1598315|NCT02906930|2936494|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-1.2|||<|0.0001|2-Sided|95.0|-1.5|-1.0||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 7 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1598316|NCT02906930|2936494|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication (hypothetical estimand).|Mean treatment difference|-0.7|||<|0.0001|2-Sided|95.0|-0.9|-0.5||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral Semaglutide 3 mg - placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1598317|NCT02906930|2936494|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.6|||<|0.0001|2-Sided|95.0|-0.8|-0.4||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 3 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1598318|NCT02906930|2936494|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.9|||<|0.0001|2-Sided|95.0|-1.1|-0.6||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 7 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1598319|NCT02906930|2936494|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any additional anti-diabetic medication for all randomised subjects regardless of premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.1|||<|0.0001|2-Sided|95.0|-1.3|-0.9||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixed model||Oral Semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to impute missing data for week 26, assuming that the missing data mechanism was missing at random within the groups used for the imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1598320|NCT02906917|2936506|Non-Inferiority|Non-inferiority of IDegAsp OD versus IGlar OD + IAsp OD was considered confirmed if the 95% confidence interval for the mean treatment difference was entirely below 0.40%.|Treatment contrast|0.07|||<|0.0001|2-Sided|95.0|-0.06|0.21||One-sided p-value for test of non-inferiority.|ANCOVA|Treatment, region, sex, previous insulin treatment and previous OAD treatment as categorical fixed effects and baseline response and age as covariate.||The response and change from baseline in response are analysed on 1000 complete, imputed data sets after multiple imputation for each treatment arm separately. A penalty of 0.4% is added to the week 26 values for all premature treatment discontinued subjects, and subject with missing HbA1c values at week 26 in the IDegAsp arm. Each of the imputed data sets are analysed through an analysis of covariance (ANCOVA).|
1598321|NCT02906813|2936511|Superiority or Other||LS Mean Ratio|0.894||||0.355||90.0|0.726|1.1|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUC∞ with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.|
1598322|NCT02906813|2936511|Superiority or Other||LS Mean Ratio|0.842||||0.191|2-Sided|90.0|0.676|1.05|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUC∞ with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.|
1598323|NCT02906813|2936512|Superiority or Other||LS Mean Ratio|0.889||||0.281|2-Sided|90.0|0.738|1.07|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUCt with factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.|
1598324|NCT02906813|2936512|Superiority or Other||LS Mean Ratio|0.85||||0.146|2-Sided|90.0|0.706|1.024|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 AUCt with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 tablet to solution. Point estimate and 90% CI in original scale were obtained by exponentiation of differences in natural-log scale.|
1598325|NCT02906813|2936513|Superiority or Other||LS Mean Ratio|0.403||||0.002|2-Sided|90.0|0.262|0.618|||ANOVA|||ANOVA was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period, and regimen and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative BA of TAK-935 administered after high-fat meal versus fasted. Point estimate and its 90% confidence interval in original scale were obtained by exponentiation of differences in natural-log scale.|
1598326|NCT02906813|2936513|Superiority or Other||Least Square (LS) Mean Ratio|0.631||||0.079|2-Sided|90.0|0.411|0.969|||ANOVA|||Analysis of variance (ANOVA) was performed on natural logarithms of TAK-935 Cmax with fixed factors of sequence, period and regimen, and random factor of participant nested within sequence. Pairwise comparisons was used to assess relative bioavailability (BA) of TAK-935 tablet to solution. Point estimate and 90 percent (%) confidence interval (CI) in original scale were obtained by exponentiation of differences in natural-log scale.|
1598327|NCT02906709|2936518|Superiority||Difference in the Least Squares Means|3.1|||<|0.001|2-Sided|95.0|2.3|4.0|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior AHA therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.
1598328|NCT02906709|2936519|Superiority||Percent Between-group Rate Difference|1.6||||0.334|2-Sided|95.0|-4.7|5.8|||Miettinen & Nurminen method||||The estimated response rates and effective sample sizes were used to obtain the confidence intervals (CIs) for within-group response rates via the Wilson score method. The CI were calculated via the stratified (non-combination prior AHA therapy status) Miettinen & Nurminen method.
1598329|NCT02906709|2936520|Superiority||Percent Between-group Rate Difference|5.8||||0.065|2-Sided|95.0|-0.7|11.5|||Miettinen & Nurminen method||||The estimated response rates and effective sample sizes were used to obtain the confidence intervals (CIs) for within-group response rates via the Wilson score method. The CI were calculated via the stratified (non-combination prior AHA therapy status) Miettinen & Nurminen method.
1598330|NCT02906709|2936521|Superiority||Difference in the Least Squares Means|-15.0||||0.002|2-Sided|95.0|-24.5|-5.4|||Constrained Longitudinal Data Analysis||||Based on a Constrained Longitudinal Data Analysis model with terms for treatment, prior AHA therapy status (yes/no), time and the interaction of time by treatment, time by prior AHA therapy status and time by treatment by prior AHA status with the restriction of a common baseline mean between two treatment groups.
1598331|NCT02906709|2936523|Superiority||Difference in % vs. Placebo|-4.1|||||2-Sided|95.0|-12.8|0.4|||||||Based on Miettinen & Nurminen method.
1598332|NCT02906709|2936525|Superiority||Difference in % vs. Placebo|7.0|||||2-Sided|95.0|-8.4|21.8|||||||Based on Miettinen & Nurminen method.
1598341|NCT02905266|2936627|Superiority||Difference of incidence rates|0.0|||||2-Sided||||||||Fixed Ratio Combination - Sequential Combination||
1598342|NCT02905266|2936628|Superiority||Percent difference in incidence rates|-3.8|||||2-Sided|95.0|-18.3|10.7|||||Fixed Ratio Combination - Sequential Combination||
1598455|NCT02900378|2936705|Other|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6|
1598343|NCT02905266|2936628|Superiority||Cochran-Mantel-Haenszel Odds Ratio|0.76|||||2-Sided|95.0|0.27|2.13|||||Ratio of Fixed Ratio Combination over Sequential Combination||
1598344|NCT02905149|2936632|Superiority||Median Difference (Final Values)|9.0|||<|0.05|2-Sided|95.0|4.0|14.5||Not adjusted for multiple comparison|Wilcoxon (Mann-Whitney)||Generalized Hodges-Lehmann median difference is used. These are robust to the possibility that the population distributions in the two groups are different in ways other than location. It may not represent the raw median difference.||
1598345|NCT02904915|2936633|Superiority|||||||0.23|||||||Fisher Exact||||
1598346|NCT02904915|2936634|Superiority|||||||0.39|||||||Fisher Exact||||
1598347|NCT02904915|2936635|Superiority|||||||0.59|||||||Fisher Exact||||
1598348|NCT02904096|2936645|Other|||||||0.177|||||||t-test, 1 sided|||Comparison between Group B: Hand palmar pinch strength (Right Hand)-baseline and Group B: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.|
1598349|NCT02904096|2936645|Other|||||||0.177|||||||t-test, 1 sided|||Comparison between Group B: Hand palmar pinch strength (Left Hand)-baseline and Group B: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.|
1598350|NCT02904096|2936645|Other|||||||0.06|||||||t-test, 1 sided|||Comparison between Group A: Hand palmar pinch strength (Right Hand)-baseline and Group A: Hand palmar pinch strength (Right Hand)-change from baseline at Month 24.|
1598351|NCT02904096|2936645|Other|||||||0.01|||||||t-test, 1 sided|||Comparison between Group A: Hand palmar pinch strength (Left Hand)-baseline and Group A: Hand palmar pinch strength (Left Hand)-change from baseline at Month 24.|
1598352|NCT02904096|2936645|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand key pinch strength (Right Hand)-baseline and Group B: Hand key pinch strength (Right Hand)-change from baseline at Month 24.|
1598353|NCT02904096|2936645|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand key pinch strength (Left Hand)-baseline and Group B: Hand key pinch strength (Left Hand)-change from baseline at Month 24.|
1598354|NCT02904096|2936645|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand key pinch strength (Right Hand)-baseline and Group A: Hand key pinch strength (Right Hand)-change from baseline at Month 24.|
1598355|NCT02904096|2936645|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand key pinch strength (Left Hand)-baseline and Group A: Hand key pinch strength (Left Hand)-change from baseline at Month 24.|
1598356|NCT02904096|2936645|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand tip pinch strength (Right Hand)-baseline and Group B: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.|
1598357|NCT02904096|2936645|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand tip pinch strength (Left Hand)-baseline and Group B: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.|
1598358|NCT02904096|2936645|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand tip pinch strength (Right Hand)-baseline and Group A: Hand tip pinch strength (Right Hand)-change from baseline at Month 24.|
1598359|NCT02904096|2936645|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand tip pinch strength (Left Hand)-baseline and Group A: Hand tip pinch strength (Left Hand)-change from baseline at Month 24.|
1598360|NCT02904096|2936645|Other||||||<|0.002|||||||t-test, 1 sided|||Comparison between Group B: Hand grip strength (Right Hand)-baseline and Group B: Hand grip strength (Right Hand)-change from baseline at Month 24.|
1598361|NCT02904096|2936645|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Hand grip strength (Left Hand)-baseline and Group B: Hand grip strength (Left Hand)-change from baseline at Month 24.|
1598362|NCT02904096|2936645|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand grip strength (Right Hand)-baseline and Group A: Hand grip strength (Right Hand)-change from baseline at Month 24.|
1598363|NCT02904096|2936645|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Hand grip strength (Left Hand)-baseline and Group A: Hand grip strength (Left Hand)-change from baseline at Month 24.|
1598364|NCT02904096|2936646|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.|
1598365|NCT02904096|2936646|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.|
1598366|NCT02904096|2936646|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.|
1598367|NCT02904096|2936646|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.|
1598368|NCT02904096|2936647|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Right Hand)-baseline and Group B: (Right Hand)-change from baseline at Month 24.|
1598369|NCT02904096|2936647|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: (Left Hand)-baseline and Group B: (Left Hand)-change from baseline at Month 24.|
1598370|NCT02904096|2936647|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Right Hand)-baseline and Group A: (Right Hand)-change from baseline at Month 24.|
1598371|NCT02904096|2936647|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: (Left Hand)-baseline and Group A: (Left Hand)-change from baseline at Month 24.|
1598372|NCT02904096|2936648|Other|||||||0.573|||||||t-test, 1 sided|||Comparison between Group B: Extension (Right Hand)-baseline and Group B: Extension (Right Hand)-change from baseline at Month 24.|
1598373|NCT02904096|2936648|Other|||||||0.781|||||||t-test, 1 sided|||Comparison between Group B: Extension (Left Hand)-baseline and Group B: Extension (Left Hand)-change from baseline at Month 24.|
1598374|NCT02904096|2936648|Other|||||||0.003|||||||t-test, 1 sided|||Comparison between Group A: Extension (Right Hand)-baseline and Group A: Extension (Right Hand)-change from baseline at Month 24.|
1598375|NCT02904096|2936648|Other|||||||0.049|||||||t-test, 1 sided|||Comparison between Group A: Extension (Left Hand)-baseline and Group A: Extension (Left Hand)-change from baseline at Month 24.|
1598376|NCT02904096|2936648|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group B: Flexion (Right Hand)-baseline and Group B: Flexion (Right Hand)-change from baseline at Month 24.|
1623034|NCT02289729|2979646|Superiority||||||<|0.0001|||||||t-test||||
1598377|NCT02904096|2936648|Other||||||<|0.054|||||||t-test, 1 sided|||Comparison between Group B: Flexion (Left Hand)-baseline and Group B: Flexion (Left Hand)-change from baseline at Month 24.|
1598378|NCT02904096|2936648|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Flexion (Right Hand)-baseline and Group A: Flexion (Right Hand)-change from baseline at Month 24.|
1598379|NCT02904096|2936648|Other||||||<|0.001|||||||t-test, 1 sided|||Comparison between Group A: Flexion (Left Hand)-baseline and Group A: Flexion (Left Hand)-change from baseline at Month 24.|
1598380|NCT02904096|2936649|Other||Difference in Percentage|1.5|||||1-Sided|95.0||3.35|||||||
1598381|NCT02904096|2936650|Non-Inferiority|Estimates for PA, PB, and PA-PB were reported together with one-sided 95% confidence interval (CI) for PA-PB constructed via the Farrington-Manning likelihood method. Here PA and PB are the percentage of subjects in Group A and B (Non-inferiority margin = 12%).|Difference in percentage|1.5|||||1-Sided|95.0||3.35|||||||
1598382|NCT02902965|2936667|Other||median TTP|10.6|||||2-Sided|95.0|7.8|12.0|||||KM estimates for median TTP with associated 95% CI||
1598383|NCT02902965|2936670|Other||PFS rate|6.6|||||2-Sided|95.0|1.6|16.9|||||Kaplan-Meier method used for PFS rate and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.||
1598384|NCT02902965|2936671|Other||ORR in %|56.8|||||2-Sided|95.0|44.7|68.2|||||Overall response = confirmed sCR + CR + VGPR + PR with corresponding 95% Exact binomial Cl||
1598385|NCT02902965|2936672|Other||median PFS|8.5|||||2-Sided|95.0|6.2|10.8|||||Kaplan-Meier estimates for median PFS and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.||
1598386|NCT02902172|2936682|Non-Inferiority||Mean Difference (Net)|0.85|||<|0.05|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1598387|NCT02900378|2936699|Other|||||||0.7725|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12|
1598388|NCT02900378|2936699|Other|||||||0.3901|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8|
1598389|NCT02900378|2936699|Other|||||||0.1158|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6|
1598390|NCT02900378|2936699|Other|||||||0.0445|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4|
1598391|NCT02900378|2936699|Other|||||||0.4525|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2|
1598392|NCT02900378|2936700|Other|||||||0.0985|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12|
1598393|NCT02900378|2936700|Other|||||||0.5343|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11|
1598394|NCT02900378|2936700|Other|||||||0.4752|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10|
1598395|NCT02900378|2936700|Other|||||||0.5702|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9|
1598396|NCT02900378|2936700|Other|||||||0.4125|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8|
1598397|NCT02900378|2936700|Other|||||||0.2019|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7|
1598398|NCT02900378|2936700|Other|||||||0.5941|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6|
1598399|NCT02900378|2936700|Other|||||||0.5016|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5|
1598400|NCT02900378|2936700|Other|||||||0.0465|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4|
1598401|NCT02900378|2936700|Other|||||||0.8335|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3|
1598402|NCT02900378|2936700|Other|||||||0.3519|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2|
1598403|NCT02900378|2936700|Other|||||||0.3231|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1|
1598404|NCT02900378|2936701|Other|||||||0.1571|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12|
1598405|NCT02900378|2936701|Other|||||||0.4228|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11|
1598406|NCT02900378|2936701|Other|||||||0.3902|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10|
1598407|NCT02900378|2936701|Other|||||||0.5237|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9|
1598408|NCT02900378|2936701|Other|||||||0.1192|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8|
1598409|NCT02900378|2936701|Other|||||||0.3499|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7|
1598410|NCT02900378|2936701|Other|||||||0.7956|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6|
1598411|NCT02900378|2936701|Other|||||||0.8017|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5|
1598412|NCT02900378|2936701|Other|||||||0.075|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4|
1598413|NCT02900378|2936701|Other|||||||0.0708|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3|
1598414|NCT02900378|2936701|Other|||||||0.0143|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2|
1598415|NCT02900378|2936701|Other|||||||0.0061|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1|
1598416|NCT02900378|2936702|Other|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12|
1598417|NCT02900378|2936702|Other|||||||0.4823|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11|
1598418|NCT02900378|2936702|Other|||||||0.4037|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10|
1598419|NCT02900378|2936702|Other|||||||0.502|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9|
1598420|NCT02900378|2936702|Other|||||||0.3174|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8|
1598421|NCT02900378|2936702|Other|||||||0.287|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7|
1598422|NCT02900378|2936702|Other|||||||0.9052|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6|
1598423|NCT02900378|2936702|Other|||||||0.9024|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5|
1598424|NCT02900378|2936702|Other|||||||0.0252|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4|
1598425|NCT02900378|2936702|Other|||||||0.1342|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3|
1598426|NCT02900378|2936702|Other|||||||0.0316|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2|
1598427|NCT02900378|2936702|Other|||||||0.0065|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1|
1598428|NCT02900378|2936703|Other|||||||0.1711|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12|
1598429|NCT02900378|2936703|Other|||||||0.8468|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11|
1598430|NCT02900378|2936703|Other|||||||0.8957|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10|
1598456|NCT02900378|2936705|Other|||||||0.0123|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4|
1598457|NCT02900378|2936705|Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2|
1598458|NCT02900378|2936706|Other|||||||0.8229|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 12|
1598459|NCT02900378|2936706|Other|||||||0.8229|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 11|
1598460|NCT02900378|2936706|Other|||||||0.6019|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 10|
1598461|NCT02900378|2936706|Other|||||||0.5301|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 9|
1598462|NCT02900378|2936706|Other|||||||0.7184|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8|
1598463|NCT02900378|2936706|Other|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 7|
1598464|NCT02900378|2936706|Other|||||||0.3486|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 6|
1598465|NCT02900378|2936706|Other|||||||0.2275|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 5|
1598466|NCT02900378|2936706|Other|||||||0.0069|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4|
1598467|NCT02900378|2936706|Other|||||||0.0297|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 3|
1598468|NCT02900378|2936706|Other|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 2|
1598469|NCT02900378|2936706|Other|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 1|
1598470|NCT02900378|2936707|Other|||||||0.2172|||||||Chi-squared|||Week 12|
1598471|NCT02900378|2936707|Other|||||||0.7754|||||||Chi-squared|||Week 8|
1598472|NCT02900378|2936707|Other|||||||0.0029|||||||Chi-squared|||Week 4|
1598473|NCT02900378|2936708|Other|||||||0.6713|||||||Chi-squared|||Week 12|
1598474|NCT02900378|2936708|Other|||||||0.9025|||||||Chi-squared|||Week 8|
1598475|NCT02900378|2936708|Other|||||||0.0516|||||||Chi-squared|||Week 4|
1598476|NCT02900378|2936709|Other||Odds Ratio (OR)|0.821|||||2-Sided|95.0|0.462|1.457||||||Increased levels (>= 10% increase) of non sedentary daytime physical activity at Week 12|
1598477|NCT02900378|2936710|Other|||||||0.1793|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8 (FAS without AE/SAE)|
1598478|NCT02900378|2936710|Other|||||||0.2414|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 8 (FAS)|
1598479|NCT02900378|2936710|Other|||||||0.3315|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4 (FAS without AE/SAE)|
1598480|NCT02900378|2936710|Other|||||||0.1814|||||||Wilcoxon (Mann-Whitney)|||Change from BL at Week 4 (FAS)|
1598481|NCT02900378|2936711|Other||Odds Ratio (OR)|1.26|||||2-Sided|95.0|0.865|1.834||||||FAS subset without AE/SAE|
1598482|NCT02900378|2936712|Other||Odds Ratio (OR)|1.25|||||2-Sided|95.0|0.863|1.811||||||FAS population|
1598483|NCT02900378|2936713|Other||Odds Ratio (OR)|1.28|||||2-Sided|95.0|0.644|2.544||||||FAS subset without AE/SAE|
1598484|NCT02900378|2936714|Other||Odds Ratio (OR)|1.25|||||2-Sided|95.0|0.634|2.464||||||FAS population|
1598485|NCT02900378|2936715|Other||Odds Ratio (OR)|1.251|||||2-Sided|95.0|0.895|1.748||||||FAS subset without AE/SAE|
1598486|NCT02900378|2936716|Other||Odds Ratio (OR)|1.228|||||2-Sided|95.0|0.882|1.708||||||FAS population|
1598487|NCT02900378|2936717|Other||Differences of least square means|-6.24|Standard Error of the Mean|6.69||0.3513|2-Sided|95.0|-19.39|6.91||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS without MI/LOCF)|
1598488|NCT02900378|2936717|Other||Differences of least square means|-5.67|Standard Error of the Mean|6.01||0.3463|2-Sided|95.0|-17.48|6.14||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS with LOCF)|
1598489|NCT02900378|2936717|Other||Differences of least square means|-6.14|Standard Error of the Mean|8.61||0.4769|2-Sided|97.5|-25.7|13.41||The comparison of treatment groups were carried out using an ANCOVA model adjusting for treatment, baseline NYHA class (NYHA II vs. III/IV) and the daily non-sedentary daytime activity baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS with MI)|
1598490|NCT02900378|2936718|Other||Differences of least square means|8.98|Standard Error of the Mean|4.58||0.0503|2-Sided|97.5|-1.31|19.27||The comparison of treatment groups were out using an analysis of covariance (ANCOVA) model adjusting for treatment and baseline NYHA class (NYHA II vs. III/IV) and the 6MWT baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS without AE/SAE)|
1598491|NCT02900378|2936718|Other||Differences of least square means|5.68|Standard Error of the Mean|4.89||0.2464|2-Sided|95.0|-3.93|15.29||The comparison of treatment groups were out using an analysis of covariance (ANCOVA) model adjusting for treatment and baseline NYHA class (NYHA II vs. III/IV) and the 6MWT baseline value as covariates.|ANCOVA|||Change from BL at Week 12 (FAS)|
1598492|NCT02899338|2936746|Equivalence|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using ANOVA|Adjusted geometric mean ratio|103.19|Standard Error of the Mean|48.21|||2-Sided|90.0|91.38|116.53|||||Standard error of the mean is actually the Inter-individual gCV|Comparison AI versus PFS|
1598493|NCT02899338|2936747|Equivalence|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using ANOVA|Adjusted geometric mean ratio|100.11|Standard Error of the Mean|23.72|||2-Sided|90.0|94.17|106.43|||||Standard error of the mean is actually the Inter-individual gCV|Comparison AI versus PFS|
1598494|NCT02899338|2936748|Equivalence|The relative bioavailability of BI 695501 using AI (A) compared with BI 695501 using PFS (B) was estimated, in an exploratory manner, by the ratios of the geometric means (A/B) using the analysis of variance (ANOVA)|Adjusted geometric mean ratio|101.71|Standard Error of the Mean|42.28|||2-Sided|90.0|91.31|113.29|||||Standard error of the mean is actually the Inter-individual geometric coefficient of variation (gCV)|Comparison AI versus PFS|
1598495|NCT02898740|2936752|Other||Mean Difference (Net)|-3.4|Standard Error of the Mean|1.7|<|0.05|2-Sided|95.0|-6.8|0.0|||Mixed Models Analysis|models were adjusted for age|treatment difference = Exercise - Health Education||
1598496|NCT02898662|2936753|Other||LS Mean difference|-2.02||||0.5403|2-Sided|95.0|-8.55|4.52||2-sided p-value|Repeated measures analysis|||Comparison between groups for FeNO. Repeated measures analysis.|
1598497|NCT02898662|2936754|Other||LS Mean difference|-0.32||||0.9686|2-Sided|95.0|-16.54|15.9||2-sided p-value|Repeated measures analysis|||Comparison between groups for PEF. Repeated measures analysis.|
1598498|NCT02898662|2936755|Other||LS Mean difference|-0.03||||0.7013|2-Sided|95.0|-0.17|0.11||2-sided p-value|Repeated measures analysis|||Comparison between groups for post-BD FEV1. Repeated measures analysis.|
1598499|NCT02898662|2936755|Other||LS Mean difference|0.06||||0.3764|2-Sided|95.0|-0.08|0.2||2-sided p-value|Repeated measures analysis|||Comparison between groups for pre-BD FEV1. Repeated measures analysis.|
1598500|NCT02898662|2936757|Other||Odds Ratio (OR)|0.88||||0.7294|2-Sided|95.0|0.41|1.86||2-sided p-value|Generalized estimating equation analysis|||Comparison between groups for participants with moderate or severe asthma exacerbation. Odds ratio was estimated using a generalized linear model based on a generalized estimating equation approach fitting treatment and visit as covariates.|
1598501|NCT02898662|2936757|Other|The null hypothesis was that the time to moderate or severe exacerbation was not different between AZD1419 and placebo.|Hazard Ratio (HR)|0.8||||0.5477|2-Sided|95.0|0.38|1.67||2-sided p-value|Regression, Cox||Hazard ratio < 1 favours AZD1419 over placebo.|Comparison between groups for time to moderate or severe asthma exacerbation. Cox regression model analysis with age and gender included as covariates.|
1598502|NCT02898662|2936758|Other||LS Mean difference|-0.03||||0.8412|2-Sided|95.0|-0.32|0.26||2-sided p-value|Repeated measures analysis|||Comparison between groups for asthma daily diary score. Repeated measures analysis.|
1598503|NCT02898662|2936759|Other||LS Mean difference|-0.02||||0.8166|2-Sided|95.0|-0.22|0.17||2-sided p-value|Repeated measures analysis|||Comparison between groups for ACQ-5 score. Repeated measures analysis.|
1598504|NCT02898662|2936760|Other||Odds Ratio (OR)|1.86||||0.2006|2-Sided|95.0|0.72|4.79||2-sided p-value|Generalized estimating equation analysis|||Comparison between groups for participants experiencing LOAC. Odds ratio was estimated using a generalized linear model based on a generalized estimating equation approach fitting treatment, visit and age and gender as covariates.|
1598505|NCT02898662|2936761|Other|The null hypothesis was that during the 52-week double-blind treatment period, the time to LOAC in the AZD1419 arm was equal to the corresponding time to LOAC in the placebo arm.|Hazard Ratio (HR)|1.05||||0.5722|2-Sided|95.0|0.59|1.87||1-sided p-value|Regression, Cox||Hazard ratio < 1 favours AZD1419 over placebo.|Comparison between groups for time to LOAC. Cox regression model analysis with age and gender included as covariates.|
1598506|NCT02898597|2936762|Superiority||||||<|0.05|||||||Fisher Exact|||Fisher Exact test was performed, comparing the proportion of participants whose abstinence was verified with salivary cotinine test between the two arms, which was significant (p = 0.02).|
1598507|NCT02898597|2936762|Superiority||Odds Ratio (OR)|12.31|||<|0.05|2-Sided|95.0|1.37|110.3|||Regression, Logistic||||
1598508|NCT02898454|2936796|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-20.73|||<|0.0001|2-Sided|95.0|-24.81|-16.65||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598509|NCT02898454|2936796|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-21.36|||<|0.0001|2-Sided|95.0|-25.45|-17.27||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598510|NCT02898454|2936797|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-0.99|||<|0.0001|2-Sided|95.0|-1.18|-0.8||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598511|NCT02898454|2936797|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-1.11|||<|0.0001|2-Sided|95.0|-1.3|-0.92||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598512|NCT02898454|2936798|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.41|||<|0.0001|2-Sided|95.0|-2.78|-2.03||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598513|NCT02898454|2936798|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.21|||<|0.0001|2-Sided|95.0|-2.59|-1.83||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w then q4w vs. Placebo|Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598709|NCT02876055|2937499|Superiority||||||<|0.542|||||||Wilcoxon (Mann-Whitney)||||
1598514|NCT02898454|2936799|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-17.36|||<|0.0001|2-Sided|95.0|-20.87|-13.85||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598515|NCT02898454|2936800|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-0.98|||<|0.0001|2-Sided|95.0|-1.15|-0.81||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598516|NCT02898454|2936801|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|10.52|||<|0.0001|2-Sided|95.0|8.98|12.07||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598517|NCT02898454|2936802|Superiority|Testing according to the hierarchical testing procedure (only performed if previous outcome measures were statistically significant).|LS mean difference|-2.44|||<|0.0001|2-Sided|95.0|-2.87|-2.02||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598518|NCT02898454|2936803|Superiority|Hierarchical testing procedure was used to control type I error. For regions outside of Japan, this first secondary endpoint was not tested unless both co-primary endpoints were significant at the 0.05 level. Hierarchical testing continued only when previous endpoint was statistically significant. For Japan submission, LMK was instead a co-primary endpoint which also had to be met before secondary endpoints were tested in the hierarchy. Last endpoint in hierarchy is Week 52 SNOT-22.|LS mean difference|-5.13|||<|0.0001|2-Sided|95.0|-5.8|-4.46||Threshold for significance at 0.05 level.|ANCOVA|||Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin's rule.|
1598519|NCT02898454|2936804|Superiority||LS mean difference|-1.8|||<|0.0001|2-Sided|95.0|-2.1|-1.51|||ANCOVA|||Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin’s rule.|
1598520|NCT02898454|2936805|Superiority||LS mean difference|-0.87|||<|0.0001|2-Sided|95.0|-1.03|-0.71|||ANCOVA|||Data was analyzed using a hybrid method of the worst-observation carried forward (WOCF) and multiple imputation (MI). The imputed completed data were analyzed by fitting ANCOVA model with the corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. Statistical inference obtained from all imputed data was combined using Rubin’s rule.|
1598521|NCT02897349|2936811|Superiority||Odds Ratio (OR)|2.293||||0.0049|2-Sided|95.0|1.286|4.091|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c|
1598522|NCT02897349|2936812|Superiority||Odds Ratio (OR)|1.481||||0.6235|2-Sided|95.0|0.309|7.105|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c|
1598523|NCT02897349|2936813|Superiority||Odds Ratio (OR)|1.793||||0.2431|2-Sided|95.0|0.673|4.78|||Regression, Logistic|||Logistic regression model with terms for treatment and type of insulin as fixed effect and continuous linear covariates baseline HbA1c|
1598524|NCT02897349|2936814|Superiority||Adjusted Mean Difference (mg/dL)|-31.95|Standard Error of the Mean|8.2||0.0001|2-Sided|95.0|-48.15|-15.75|||ANCOVA|||Based on analysis of covariance (ANCOVA) model including fixed effect treatment and type of insulin, and linear covariates baseline HbA1c and baseline 2-h PPG.|
1598525|NCT02897349|2936815|Superiority||Adjusted Mean Difference (mg/dL)|-6.2|Standard Error of the Mean|5.1||0.2241|2-Sided|95.0|-16.2|3.8|||Mixed model repeated measures|||Based on MMRM including fixed effects treatment, week, type of insulin, and treatment by week interaction, linear covariates baseline HbA1c, baseline FPG baseline FPG by week interaction and random effect for patient. Within−patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).|
1598526|NCT02897349|2936816|Superiority||Adjusted Mean Difference (%)|-0.4|Standard Error of the Mean|0.13||0.0016|2-Sided|95.0|-0.65|-0.16|||Mixed model repeated measures|||Based on Mixed-effect Model Repeated Measures (MMRM) including fixed effects treatment, week, type of insulin, and treatment by week interaction, linear covariates baseline HbA1c, baseline HbA1c by week interaction and random effect for patient. Within−patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).|
1598527|NCT02897141|2936817|Superiority||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.28||0.48|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||User Control|
1598528|NCT02897141|2936817|Superiority||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.26||0.803|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Perceived ease of use|
1598529|NCT02897141|2936817|Superiority||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.26||0.899|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Perceived usefulness|
1598530|NCT02897141|2936817|Superiority||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.2||0.166|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Quality of life|
1598531|NCT02897141|2936817|Superiority||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.23||0.743|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Overall|
1598532|NCT02897141|2936818|Superiority||Mean Difference (Final Values)|-4.88|Standard Error of the Mean|5.06||0.338|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Visual analogue scale|
1598533|NCT02897141|2936818|Superiority||Mean Difference (Final Values)|-1.51|Standard Error of the Mean|0.62||0.017|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||CASE adherence index|
1598534|NCT02897141|2936819|Superiority||Mean Difference (Final Values)|-2.52|Standard Error of the Mean|2.19||0.252|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis||||
1598535|NCT02897141|2936820|Superiority||Mean Difference (Final Values)|1.25|Standard Error of the Mean|1.66||0.454|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Pain interference|
1598536|NCT02897141|2936820|Superiority||Mean Difference (Final Values)|0.72|Standard Error of the Mean|2.29||0.754|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Satisfaction with participation in social roles|
1598537|NCT02897141|2936820|Superiority||Mean Difference (Final Values)|2.58|Standard Error of the Mean|2.03||0.208|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Sleep Disturbance|
1598538|NCT02897141|2936820|Superiority||Mean Difference (Final Values)|0.4|Standard Error of the Mean|2.07||0.848|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fatigue|
1598539|NCT02897141|2936820|Superiority||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|1.81||0.841|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Depression|
1598540|NCT02897141|2936820|Superiority||Mean Difference (Final Values)|1.71|Standard Error of the Mean|1.68||0.312|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Anxiety|
1598541|NCT02897141|2936820|Superiority||Mean Difference (Final Values)|0.79|Standard Error of the Mean|1.25||0.529|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Physical Function|
1598542|NCT02897141|2936821|Superiority||Mean Difference (Final Values)|-0.81|Standard Error of the Mean|3.6||0.822|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Mental health summary scale|
1598543|NCT02897141|2936821|Superiority||Mean Difference (Final Values)|-0.93|Standard Error of the Mean|4.47||0.836|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Physical health summary scale|
1598544|NCT02897141|2936821|Superiority||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|3.93||0.96|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||General health scale|
1598545|NCT02897141|2936821|Superiority||Mean Difference (Final Values)|-14.33|Standard Error of the Mean|5.18||0.007|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Pain scale|
1598546|NCT02897141|2936821|Superiority||Mean Difference (Final Values)|-8.93|Standard Error of the Mean|5.8||0.128|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Social functioning scale|
1598547|NCT02897141|2936821|Superiority||Mean Difference (Final Values)|1.48|Standard Error of the Mean|3.73||0.693|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Emotional well-being scale|
1598548|NCT02897141|2936821|Superiority|[Not specified]|Mean Difference (Final Values)|-1.0|Standard Error of the Mean|4.09||0.807|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|[Not specified]|[Not specified]|Energy/fatigue scale|[Not specified]
1598549|NCT02897141|2936821|Superiority|[Not specified]|Mean Difference (Final Values)|3.5|Standard Error of the Mean|9.91||0.725|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|[Not specified]|[Not specified]|Role limitations due to emotional problems scale|
1598550|NCT02897141|2936821|Superiority|[Not specified]|Median Difference (Final Values)|7.47|Standard Error of the Mean|10.02||0.458|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|[Not specified]|[Not specified]|Role limitations due to physical health scale|
1598551|NCT02897141|2936821|Superiority|[Not specified]|Mean Difference (Final Values)|-3.06|Standard Error of the Mean|7.27||0.001|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|[Not specified]|[Not specified]|Physical functioning scale|
1598552|NCT02897141|2936822|Superiority||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.107||0.02|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Weight loss or wasting|
1598553|NCT02897141|2936822|Superiority||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.139||0.349|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Skin problems|
1598554|NCT02897141|2936822|Superiority||Mean Difference (Final Values)|-0.485|Standard Error of the Mean|0.157||0.002|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Neuropathy|
1598555|NCT02897141|2936822|Superiority||Mean Difference (Final Values)|0.063|Standard Error of the Mean|0.101||0.534|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Nausea or vomiting|
1598556|NCT02897141|2936822|Superiority||Mean Difference (Net)|-0.275|Standard Error of the Mean|0.132||0.037|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fever, chills, sweats|
1598557|NCT02897141|2936822|Superiority||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.175||0.987|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Fatigue|
1623035|NCT02289729|2979647|Superiority|||||||0.4183|||||||t-test||||
1598558|NCT02897141|2936822|Superiority||Mean Difference (Final Values)|-0.138|Standard Error of the Mean|0.126||0.275|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Dizziness|
1598559|NCT02897141|2936822|Superiority|Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mean Difference (Final Values)|-0.174|Standard Error of the Mean|0.145||0.23|2-Sided||||||Mixed Models Analysis|||Difficulty remembering|
1598560|NCT02897141|2936822|Superiority||Mean Difference (Final Values)|-0.073|Standard Error of the Mean|0.162||0.651|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Difficulty falling or staying asleep|
1598561|NCT02897141|2936822|Superiority||Mean Difference (Final Values)|-0.007|Standard Error of the Mean|0.141||0.962|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Diarrhea|
1598562|NCT02897141|2936822|Superiority||Mean Difference (Final Values)|-0.533|Standard Error of the Mean|0.163||0.001|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Depression|
1598563|NCT02897141|2936822|Superiority||Mean Difference (Final Values)|-0.149|Standard Error of the Mean|0.161||0.356|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count; a=0.05|Mixed Models Analysis|||Cough or Shortness of Breath|
1598564|NCT02897141|2936822|Superiority||Mean Difference (Final Values)|-0.541|Standard Error of the Mean|0.156||0.001|2-Sided|||||Model controlled for age, sex, race, education, and CD4 count ; a=0.05|Mixed Models Analysis|||Anxiety|
1598565|NCT02896855|2936858|Other||Treatment Difference|-0.51|||||2-Sided|95.0|-1.79|0.77|||||The treatment difference for change from baseline to maximum on-treatment decrease in LVEF is defined as Arm B: Pertuzumab minus Arm A: Placebo.||
1598566|NCT02896855|2936865|Other||Cox Proportional Hazard|0.78||||0.2867|2-Sided|95.0|0.49|1.24|||Log Rank|Two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.|
1598567|NCT02896855|2936866|Other||Difference in Objective Response|9.98||||0.1108|2-Sided|95.0|-2.65|22.6|||Fisher Exact|Unadjusted|The difference in objective response is calculated as Arm B: Pertuzumab minus Arm A: Placebo. 95% CI was calculated using Hauck-Anderson method.|Hypothesis testing is considered exploratory in this bridging study.|
1598568|NCT02896855|2936866|Other||Difference in Objective Response|9.98||||0.1126|2-Sided|95.0|-2.65|22.6|||Cochran-Mantel-Haenszel|Statistical test is stratified by disease type and hormone receptor status.|The difference in objective response is calculated as Arm B: Pertuzumab minus Arm A: Placebo. 95% CI was calculated using Hauck-Anderson method.|Hypothesis testing is considered exploratory in this bridging study.|
1598569|NCT02896855|2936870|Other||Unstratified Hazard Ratio|0.71||||0.0556|2-Sided|95.0|0.5|1.01|||Log Rank|This two-sided log-rank test was unstratified.|This unstratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.|
1598570|NCT02896855|2936870|Other||Stratified Hazard Ratio|0.69||||0.0418|2-Sided|95.0|0.49|0.99|||Log Rank|A two-sided log-rank test was used, stratified by disease type and hormone-receptor status.|This stratified Hazard Ratio (HR) is calculated as Arm B: Pertuzumab versus Arm A: Placebo. Cox proportional hazards model, stratified by disease type and hormone-receptor status, was used to estimate HR and its 95% CI.|Hypothesis testing is considered exploratory in this bridging study.|
1598571|NCT02892513|2937045|Superiority|||||||0.97|||||||t-test, 2 sided||||
1598572|NCT02892409|2937047|Equivalence|LS Mean Ratio (TAK-438/Lansoprazole), 95% CI of the ratio were obtained by taking the anti-log of the difference or confidence limits of difference between the LS means of test and reference on the natural logarithmic scale.|LS Mean Ratio|93.6|||||2-Sided|95.0|67.137|130.569|||||||
1598573|NCT02892409|2937048|Equivalence|LS Mean Ratio (TAK-438/Lansoprazole), 95 percent (%) confidence interval (CI) of the ratio were obtained by taking the anti-log of the difference or confidence limits of difference between the LS means of test and reference on the natural logarithmic scale.|Least Square (LS) Mean Ratio|105.1|||||2-Sided|95.0|66.051|167.183|||||||
1598574|NCT02892344|2937054|Superiority||Hazard Ratio (HR)|0.29|||<|0.001|2-Sided|95.0|0.14|0.59|||Regression, Cox||||
1598575|NCT02892344|2937057|Superiority||Mean Difference (Net)|0.149|||<|0.001|2-Sided|95.0|0.064|0.234|||Mixed Models Analysis||||
1598576|NCT02892344|2937058|Superiority||Mean Difference (Net)|8.1|||<|0.001|2-Sided|95.0|4.3|11.8|||Mixed Models Analysis||||
1598577|NCT02892344|2937059|Superiority||Mean Difference (Net)|-0.15|||<|0.001|2-Sided|95.0|-0.22|-0.08|||Mixed Models Analysis|||Daytime number of puffs of rescue medication|
1598578|NCT02892344|2937059|Superiority||Mean Difference (Net)|-0.11|||<|0.001|2-Sided|95.0|-0.16|-0.05|||Mixed Models Analysis|||Night-time number of puffs of rescue medication|
1598579|NCT02892344|2937060|Superiority||Mean Difference (Net)|-0.204|||<|0.001|2-Sided|95.0|-0.277|-0.131|||Mixed Models Analysis||||
1598580|NCT02892344|2937063|Superiority||Mean Difference (Net)|26.1|||<|0.001|2-Sided|95.0|21.0|31.2|||Mixed Models Analysis|||Mean Evening PEF|
1598581|NCT02892344|2937063|Superiority||Mean Difference (Net)|27.2|||<|0.001|2-Sided|95.0|22.1|32.4|||Mixed Models Analysis|||Mean Morning PEF|
1598582|NCT02892344|2937064|Superiority||Mean Difference (Net)|0.288|||<|0.001|2-Sided|95.0|0.231|0.345|||Mixed Models Analysis|||Pre-dose trough FEF25-75%|
1598583|NCT02892344|2937064|Superiority||Mean Difference (Net)|0.1|||<|0.001|2-Sided|95.0|0.061|0.139|||Mixed Models Analysis|||Pre-dose trough FVC|
1598584|NCT02892344|2937065|Superiority||Mean Difference (Net)|0.176|||<|0.001|2-Sided|95.0|0.145|0.207|||Mixed Models Analysis||||
1598585|NCT02892344|2937066|Superiority||Mean Difference (Net)|0.132|||<|0.001|2-Sided|95.0|0.105|0.158|||Mixed Models Analysis||||
1598586|NCT02892344|2937067|Superiority||Mean Difference (Net)|-0.218|||<|0.001|2-Sided|95.0|-0.293|-0.143|||Mixed Models Analysis||||
1598587|NCT02892344|2937068|Superiority||Mean Difference (Net)|0.182|||<|0.001|2-Sided|95.0|0.148|0.217|||Mixed Models Analysis||||
1598635|NCT02886715|2937193|Equivalence|90% Confidence Interval for the least-squares mean Test/Reference ratios to be within 80-125%|Test-to-Reference Ratio|98.75|||||2-Sided|90.0|94.39|103.31|||||||
1598588|NCT02891200|2937095|Superiority||Predicted Mean Difference|1.46||||0.467|2-Sided|95.0|-2.47|5.38|||Mixed Models Analysis|Mixed effects linear model with study site and setting as fixed effects, and adjusted for baseline SGRQ domain scores.|||
1598589|NCT02891174|2937096|Superiority|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Overall satisfaction with pain control during study period|
1598590|NCT02891174|2937096|Superiority|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Second intervention (24 hours)|
1598591|NCT02891174|2937096|Superiority|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||First intervention (24 hours)|
1598592|NCT02891174|2937097|Other|||||||0.76|||||||t-test, 2 sided||||
1598593|NCT02891174|2937098|Superiority|||||||0.88||||||Overall pain|t-test, 2 sided|||Change in overall pain|
1598594|NCT02891174|2937098|Superiority|||||||0.91||||||Perineal pain|t-test, 2 sided|||Change in perineal pain|
1598595|NCT02891174|2937098|Superiority|||||||0.59||||||Abdominal pain|t-test, 2 sided|||Change in abdominal pain|
1598596|NCT02891174|2937099|Equivalence|margin=10 mmHg|Mean Difference (Final Values)|1.0|||||2-Sided|95.0|-3.7|5.7|||||The adjusted mean difference between ibuprofen and acetaminophen is presented here. The adjusted mean difference was calculated using a linear mixed model adjusting for time period by intention-to-treat principles.||
1598597|NCT02891070|2937100|Other||Mean Difference (Net)|-5.11|||||2-Sided|95.0|-13.6|3.39|||||||
1598598|NCT02891070|2937101|Other|||||||0.9943|||||||Wilcoxon (Mann-Whitney)||||
1598599|NCT02891070|2937102|Other|||||||0.1015|||||||Wilcoxon (Mann-Whitney)||||
1598600|NCT02891070|2937103|Other|||||||0.0241|||||||Wilcoxon (Mann-Whitney)||||
1598601|NCT02891070|2937104|Other||Mean Difference (Net)|-9.29|||||2-Sided|95.0|-21.11|2.54|||||Difference in Average Predicted Proportion (Tisseel - Duraseal)||
1598602|NCT02891070|2937106|Non-Inferiority|To demonstrate non-inferiority (NI) of Tisseel to DuraSeal for the primary endpoint, the lower limit of the 95% CI (based on normal approximation) for the difference in average predicted proportions had to be greater than -10%.|Mean Difference (Net)|-9.29|||||2-Sided|95.0|-21.11|2.54|||||Difference in Average Predicted Proportion (Tisseel - Duraseal)||
1598603|NCT02890381|2937130|Superiority|||||||0.73||||||The threshold for statistical significance is 0.05.|Log Rank||||
1598604|NCT02890381|2937131|Superiority|||||||0.64||||||Since the sample sizes are unequal, at the suggestion of the DSMB statistician, a 1-sided Fisher's exact test was used to test the hypothesis that the proportions of >=4-fold rises were higher in the vaccinated group than in the placebo group.|Fisher Exact||||
1598605|NCT02890381|2937136|Other||% placebo with unsolicited AEs|50.0|||||2-Sided|90.0|15.0|85.0|||||||
1598606|NCT02890381|2937136|Other||% vaccinees with unsolicited AEs|36.0|||||2-Sided|90.0|14.0|65.0|||||||
1598607|NCT02890381|2937137|Other||% placebo recipients with solicited AEs|100.0|||||2-Sided|90.0|61.0|100.0|||||||
1598608|NCT02890381|2937137|Other||% vaccine recipients with solicited AEs|64.0|||||2-Sided|90.0|35.0|86.0|||||||
1598609|NCT02888756|2937155|Superiority|||||||0.14|||||||Mixed Models Analysis|||Analyzed for week 6, to provide statistical information for decision on execution of intracellular cytokine staining (ICS).|
1598610|NCT02887989|2937175|Superiority|||||||0.6339|||||||t-test, 2 sided||||
1598611|NCT02887989|2937176|Superiority|||||||0.657|||||||t-test, 2 sided||||
1598612|NCT02887183|2937178|Other||Least Squared Mean|9.32|||<|0.0001|2-Sided|95.0|7.94|10.69|||ANCOVA||||
1598613|NCT02887183|2937179|Other|Pearson's Correlation||||||0.0012|||||||t-test, 2 sided|||Subjects not receiving target dose|
1598614|NCT02887183|2937179|Other|Pearson's Correlation||||||0.0011|||||||t-test, 2 sided|||Subjects with HFrEF and “low” NT-proBNP|
1598615|NCT02887183|2937179|Other|Pearson's Correlation||||||0.0029|||||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve|
1598616|NCT02887183|2937180|Other|Pearson's Correlation||||||0.2685|||||||t-test, 2 sided|||Subjects not receiving target dose|
1598617|NCT02887183|2937180|Other|Pearson's Correlation||||||0.0495|||||||t-test, 2 sided|||Subjects with HFrEF and “low” NT-proBNP|
1598618|NCT02887183|2937180|Other|Pearson's Correlation||||||0.2498|||||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve|
1598619|NCT02887183|2937181|Other|Pearson's Correlation||||||0.0181|||||||t-test, 2 sided|||Subjects not receiving target dose|
1598620|NCT02887183|2937181|Other|Pearson's Correlation||||||0.0012|||||||t-test, 2 sided|||Subjects with HFrEF and “low” NT-proBNP|
1598621|NCT02887183|2937181|Other|Pearson's Correlation||||||0.006|||||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve|
1598622|NCT02887183|2937182|Other|Pearson's Correlation||||||0.0956|||||||t-test, 2 sided|||Subjects not receiving target dose|
1598623|NCT02887183|2937182|Other|Pearson's Correlation||||||0.0003|||||||t-test, 2 sided|||Subjects with HFrEF and “low” NT-proBNP|
1598624|NCT02887183|2937182|Other|Pearson's Correlation|||||<|0.0001|||||||t-test, 2 sided|||Subjects with new onset HF and/or RAAS naïve|
1598625|NCT02887183|2937183|Other|Pearson's Correlation|||||<|0.0001|||||||t-test, 2 sided|||LVESVi, LVEDVi, LAVi. LVEF|
1598626|NCT02887183|2937184|Other|Pearson's Correlation|||||<|0.0001|||||||t-test, 2 sided|||LVESVi, LVEDVi, LAVi. LVEF|
1598627|NCT02887183|2937185|Other||Least Squared Mean|9.37|||<|0.001|2-Sided|95.0|8.84|9.9|||ANCOVA||||
1598628|NCT02887183|2937186|Other||Least Squared Mean|-15.29|||<|0.0001|2-Sided|95.0|-16.03|-14.55|||ANCOVA|||LVESVi|
1598629|NCT02887183|2937186|Other||Least Squared Mean|-12.25|||<|0.0001|2-Sided|95.0|-12.92|-11.58|||ANCOVA|||LVEDVi|
1598630|NCT02887183|2937186|Other||Least Squared Mean|-7.57|||<|0.0001|2-Sided|95.0|-7.98|-7.15|||ANCOVA|||LAVi|
1598631|NCT02887183|2937187|Other||Least Squared Geometric Mean Ratio|0.632|||<|0.0001|2-Sided|95.0|0.5865|0.681|||ANCOVA||||
1598632|NCT02886715|2937191|Superiority||Mean Difference (Final Values)|-4.39||||0.0354|2-Sided|95.0|-8.48|-0.3|||ANOVA|with treatment and site as fixed effects in the model|||
1598633|NCT02886715|2937191|Equivalence|90% Confidence Interval for the least-squares mean Test/Reference ratios to be within 80-125%|Test-to-Reference Ratio|98.39|||||2-Sided|90.0|93.42|103.61|||||||
1598634|NCT02886715|2937193|Superiority||Mean Difference (Final Values)|-5.17||||0.0185|2-Sided|95.0|-9.46|-0.87|||ANOVA|with treatment and site as fixed effects in the model|||
1598636|NCT02886702|2937194|Superiority|||||||0.0712|||||||Cochran-Mantel-Haenszel|stratified by clinical site|||
1598637|NCT02886702|2937194|Superiority|||||||1|||||||Cochran-Mantel-Haenszel|stratified by clinical site|||
1598638|NCT02886702|2937195|Superiority|||||||0.0613|||||||Cochran-Mantel-Haenszel|stratified by clinical site|||
1598639|NCT02886702|2937195|Superiority|||||||0.8105|||||||Cochran-Mantel-Haenszel|stratified by clinical site|||
1598640|NCT02886702|2937196|Superiority|Last Observation Carried Forward (LOCF) for missing efficacy values||||||0.352|||||||Cochran-Mantel-Haenszel|stratified by clinical site|||
1598641|NCT02886702|2937196|Equivalence|90% confidence interval on the difference between the proportions to be within [-20%, +20%].|Risk Difference (RD)|-4.5||||||90.0|-12.6|3.6|||||||
1598642|NCT02885636|2937212|Superiority|||||||0.09|||||||t-test, 2 sided||||
1598643|NCT02885636|2937213|Superiority|||||||0.004|||||||t-test, 2 sided||||
1598644|NCT02885636|2937214|Superiority|||||||0.7|||||||t-test, 2 sided||||
1598645|NCT02885636|2937215|Superiority|||||||0.004|||||||t-test, 2 sided||||
1598646|NCT02885636|2937216|Superiority|||||||0.03|||||||t-test, 2 sided||||
1598647|NCT02885636|2937217|Superiority|||||||0.0007|||||||t-test, 2 sided||||
1598648|NCT02885636|2937218|Superiority|||||||0.08|||||||t-test, 2 sided||||
1598649|NCT02885636|2937219|Superiority|||||||0.0002|||||||t-test, 2 sided||||
1598650|NCT02885636|2937220|Superiority|||||||0.2|||||||t-test, 2 sided||||
1598651|NCT02885636|2937221|Superiority|||||||0.001|||||||t-test, 2 sided||||
1598652|NCT02885636|2937222|Superiority|||||||0.9|||||||t-test, 2 sided||||
1598653|NCT02885636|2937223|Superiority|||||||0.7|||||||t-test, 2 sided||||
1598654|NCT02885636|2937224|Superiority|||||||0.3|||||||t-test, 2 sided||||
1598655|NCT02885636|2937225|Superiority|||||||0.003|||||||ANCOVA||||
1598656|NCT02885181|2937243|Superiority||LS Means of Differences|-0.33||||0.072|2-Sided|95.0|-0.7|0.03|||Cochran-Mantel-Haenszel||||
1598657|NCT02885181|2937243|Superiority||LS Means of Differences|0.2||||0.293|2-Sided|95.0|-0.17|0.57|||Cochran-Mantel-Haenszel||||
1598658|NCT02885181|2937243|Superiority||LS Means of Differences|-0.12||||0.528|2-Sided|95.0|-0.49|0.25|||Cochran-Mantel-Haenszel||||
1598659|NCT02885181|2937244|Superiority||Difference in Response Rates|24.5||||0.072|2-Sided|95.0|-6.6|50.1|||Cochran-Mantel-Haenszel||||
1598660|NCT02885181|2937244|Superiority||Difference in Response Rates|1.4||||0.896|2-Sided|95.0|-28.0|31.7|||Cochran-Mantel-Haenszel||||
1598661|NCT02885181|2937244|Superiority||Difference in Response Rates|-8.6||||0.36|2-Sided|95.0|-37.9|22.5|||Cochran-Mantel-Haenszel||||
1598662|NCT02885181|2937245|Superiority||Difference in Response Rates|24.9||||0.092|2-Sided|95.0|-6.6|51.5|||Cochran-Mantel-Haenszel||||
1598663|NCT02885181|2937245|Superiority||Difference in Response Rates|-2.7||||0.852|2-Sided|95.0|-32.0|27.5|||Cochran-Mantel-Haenszel||||
1598664|NCT02885181|2937245|Superiority||Difference in Response Rates|-2.7||||0.853|2-Sided|95.0|-32.0|27.5|||Cochran-Mantel-Haenszel||||
1598665|NCT02885181|2937246|Superiority||Difference in Response Rates|40.0||||0.009|2-Sided|95.0|10.7|65.6|||Cochran-Mantel-Haenszel||||
1598666|NCT02885181|2937246|Superiority||Difference in Response Rates|-15.9||||0.277|2-Sided|95.0|-44.7|13.8|||Cochran-Mantel-Haenszel||||
1598667|NCT02885181|2937246|Superiority||Difference in Response Rates|-5.9||||0.66|2-Sided|95.0|-36.0|24.0|||Cochran-Mantel-Haenszel||||
1598668|NCT02885181|2937247|Superiority||LS Means of Differences|0.0||||0.002|2-Sided|95.0|0.0|0.0|||Cochran-Mantel-Haenszel||||
1598669|NCT02885181|2937247|Superiority||LS Means of Differences|0.4||||0.3|2-Sided|95.0|0.0|1.16|||Cochran-Mantel-Haenszel||||
1598670|NCT02885181|2937247|Superiority||Least Squares (LS) Means of Differences|0.01||||0.978|2-Sided|95.0|0.0|0.76|||Cochran-Mantel-Haenszel||||
1598671|NCT02882152|2937277|Superiority or Other||||||<|0.05|||||||ANOVA|||"Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groups"|
1598672|NCT02882152|2937278|Superiority or Other||||||<|0.05|||||||ANOVA|||"Results were compared by means of the ANOVA of repeated measures followed by Bonferroni test.~Comparing: all four moments, from zero to 72hs within femoral blockade group, all four moments within morphine group, and all four moments between the groups"|
1598673|NCT02881775|2937280|Superiority|||||||0.2192||||||Threshold for statistical significance is P < .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of ICF BL Change (treatment by time)|
1598674|NCT02881775|2937281|Superiority|||||||0.3889||||||Threshold for statistical significance is P < .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of SICI BL Change (treatment by time)|
1598675|NCT02881775|2937282|Superiority|||||||0.3665||||||Threshold for statistical significance is P < .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 33||Comparison of AMT-MEP BL Change (treatment by time)|
1598676|NCT02881775|2937283|Superiority|||||||0.7706||||||Threshold for statistical significance is P < .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||Comparison of TUG BL Change (treatment by time)|
1598677|NCT02881775|2937284|Superiority|||||||0.6608||||||Threshold for statistical significance is P < .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||PPT BL Change (treatment by time)|
1598678|NCT02881775|2937285|Superiority|||||||0.444||||||threshold for statistical significance is p < .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 43.1||Comparison of NPRS BL Change (treatment by time)|
1598679|NCT02881775|2937286|Superiority|||||||0.9768||||||The threshold for statistical significance was p < .05|ANOVA|Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors. DF = 45||Comparison of MVIC BL Change (treatment by time)|
1598708|NCT02876055|2937499|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1598680|NCT02881775|2937287|Superiority|||||||0.9994||||||The threshold for significance was P <.05|ANOVA|"Repeated measures ANOVA with restricted maximum likelihood estimation and Kenward-Roger standard errors.~Degrees of freedom (DF) = 34.1"||Comparison of CAR BL Change (treatment by time)|
1598681|NCT02880514|2937349|Superiority|||||||0.68|||||||t-test, 2 sided||||
1598682|NCT02880514|2937350|Superiority|||||||0.0391||||||P-value not adjusted for multiplicity.|McNemar|McNemar’s exact binomial test was employed to obtain the two-sided p-value at alpha level of 0.05.|||
1598683|NCT02878590|2937430|Superiority|||||||0.0093|||||||t-test, 2 sided||||
1598684|NCT02878330|2937442|Superiority||Relative Risk Reduction|78.4||||0.0002|2-Sided|95.0|51.9|90.3|||Poisson regression||||
1598685|NCT02878330|2937443|Superiority||Relative Risk Reduction|70.1|||<|0.0001|2-Sided|95.0|52.3|81.2|||Poisson regression||||
1598686|NCT02877927|2937446|Non-Inferiority|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.3|||||2-Sided|95.0|-0.6|5.6|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.||
1598687|NCT02877927|2937447|Non-Inferiority|A non-inferiority margin of 10% was used for the analysis.|treatment difference|3.3|||||2-Sided|95.0|-2.2|8.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.||
1598688|NCT02877927|2937448|Non-Inferiority|A non-inferiority margin of 10% was used for the analysis.|treatment difference|5.0|||||2-Sided|95.0|-0.2|10.3|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.||
1598689|NCT02877095|2937455|Other|||||||||||||||||All subjects on study received active drug.|Total count of events is provided.
1598690|NCT02877004|2937461|Superiority|||||||0.368|||||||ANCOVA|Data were analyzed using analysis of covariance with the baseline value included as the covariate|||
1598691|NCT02877004|2937462|Superiority|||||||0.723|||||||ANCOVA|Data were analyzed using analysis of covariance with the baseline value included as the covariate.|||
1598692|NCT02876900|2937466|Superiority||Least Square Mean Difference|-0.4|Standard Error of the Mean|0.099|<|0.001|2-Sided|95.0|-0.64|-0.25||Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.|
1598693|NCT02876900|2937466|Superiority||Least Square Mean Difference|-0.4|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.55|-0.16||Adjusted p-value was calculated according to the Hochberg procedure. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.|
1598694|NCT02876900|2937467|Superiority|Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison.|Least Square Mean Difference|-6.6|Standard Error of the Mean|1.63|<|0.001|2-Sided|95.0|-9.81|-3.4||Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.|
1598695|NCT02876900|2937467|Superiority|Assuming an effect size of 0.35 on the change in PANSS total score from baseline to Week 6 for the 2 pairwise comparisons between each active asenapine maleate transdermal patch treatment arm and placebo, the power for detecting a statistically significant HP-3070 advantage was approximately 0.90, having 204 evaluable participants per each treatment arm using a 2-sided alpha level of 0.025 for each comparison.|Least Square Mean Difference|-4.8|Standard Error of the Mean|1.634|<|0.003|2-Sided|95.0|-8.06|-1.64||Adjusted p-value was calculated according to the truncated Hochberg procedure with a truncation factor y=0.9. Adjustment for multiple comparisons uses a parallel gatekeeping procedure.|Mixed Model Repeated Measures Analysis|||The mixed model for repeated measures includes treatment, country, visit, treatment by visit interaction, and baseline value as covariates, and participant as random effect. The correlation of repeated measures within a participant is estimated with an unstructured covariance matrix. The Kenward-Rogers method is used to estimate the denominator degrees of freedom.|
1598696|NCT02876601|2937471|Superiority|||||||0.938|||||||Wilcoxon (Mann-Whitney)||||
1598697|NCT02876601|2937472|Superiority|||||||0.423|||||||Wilcoxon (Mann-Whitney)||||
1598698|NCT02876601|2937473|Superiority|||||||0.877|||||||Wilcoxon (Mann-Whitney)||||
1598699|NCT02876601|2937474|Superiority|||||||0.918|||||||Wilcoxon (Mann-Whitney)||||
1598700|NCT02876601|2937475|Superiority|||||||0.796|||||||Wilcoxon (Mann-Whitney)||||
1598701|NCT02876601|2937476|Superiority|||||||0.326|||||||Wilcoxon (Mann-Whitney)||||
1598702|NCT02876601|2937477|Superiority|||||||0.026|||||||Wilcoxon (Mann-Whitney)||||
1598703|NCT02876601|2937478|Superiority|||||||0.642|||||||Wilcoxon (Mann-Whitney)||||
1598704|NCT02876601|2937479|Superiority|||||||0.039|||||||Wilcoxon (Mann-Whitney)||||
1598705|NCT02876601|2937480|Superiority|||||||0.148|||||||Wilcoxon (Mann-Whitney)||||
1598706|NCT02876601|2937481|Superiority|||||||0.408|||||||Wilcoxon (Mann-Whitney)||||
1598707|NCT02876055|2937499|Superiority|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1598710|NCT02875977|2937500|Superiority||Mean Difference (Final Values)|-4.456|Standard Error of the Mean|6.5481||0.5|2-Sided|95.0|-17.6149|8.7028|||t-test, 2 sided|||The null hypothesis is that there is no difference in the change from pre-PFPT to post-PFPT UDI-6 scores between those assigned to standard versus experimental counseling|
1598711|NCT02875977|2937501|Superiority||Z-Score|-1.4262||||0.16|2-Sided||||||Wilcoxon (Mann-Whitney)|||Among those who initiated PFPT therapy, the null hypothesis is that there is no difference in the number of days to initiating PFPT therapy between those assigned to standard versus experimental counseling|
1598712|NCT02875977|2937502|Superiority||Odds Ratio (OR)|1.044||||0.9|2-Sided|95.0|0.517|2.11|||Regression, Logistic|The statistical test of the hypothesis excludes the three individuals with unknown PFPT discharge status||The null hypothesis is that there is no difference in the odds of discharge from PFPT between those assigned to standard versus experimental counseling|
1598713|NCT02875977|2937503|Superiority||Odds Ratio (OR)|0.564||||0.056|2-Sided|95.0|0.314|1.014|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of initiating PFPT between those assigned to standard versus experimental counseling|
1598714|NCT02875977|2937504|Superiority||Odds Ratio (OR)|1.794||||0.17|2-Sided|95.0|0.782|4.119|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of completing half of the recommended PFPT visits between those assigned to standard versus experimental counseling|
1598715|NCT02875366|2937515|Superiority||Least Squares Mean Difference|6.2||||0.1257|2-Sided|95.0|-1.8|14.1|||Mixed effects model for repeated measure||||
1598716|NCT02875366|2937516|Superiority||Least Squares Mean Difference|0.9||||0.3905|2-Sided|95.0|-1.2|3.1|||Mixed effects model for repeated measure||||
1598717|NCT02875366|2937517|Superiority||Least Squares Mean Difference|0.2||||0.3961|2-Sided|95.0|-0.3|0.6|||Mixed effects model for repeated measure||||
1598718|NCT02875366|2937518|Superiority||Least Squares Mean Difference|3.5||||0.3091|2-Sided|95.0|-3.4|10.4|||Mixed effects model for repeated measure||||
1598719|NCT02875366|2937519|Superiority||Least Squares Mean Difference|3.4||||0.146|2-Sided|95.0|-1.2|8.1|||Mixed effects model for repeated measure||||
1598720|NCT02875366|2937520|Superiority||Least Squares Mean Difference|1.0||||0.5889|2-Sided|95.0|-2.7|4.7|||Mixed effects model for repeated measure||||
1598721|NCT02875366|2937521|Superiority||Least Squares Mean Difference|0.3||||0.6409|2-Sided|95.0|-0.9|1.5|||Mixed effects model for repeated measure||||
1598722|NCT02875366|2937522|Superiority||Least Squares Mean Difference|-6.32||||0.0613|2-Sided|95.0|-12.94|0.31|||Mixed effects model for repeated measure||||
1598723|NCT02875366|2937523|Superiority||Least Squares Mean Difference|-0.6||||0.0226|2-Sided|95.0|-1.12|-0.09|||Mixed effects model for repeated measure||||
1598724|NCT02875366|2937524|Superiority||Least Squares Mean Difference|-7.5||||0.2237|2-Sided|95.0|-19.8|4.7|||Mixed effects model for repeated measure||||
1598725|NCT02875366|2937525|Superiority||Least Squares Mean Difference|-149.6||||0.0439|2-Sided|95.0|-295.0|-4.2|||Mixed effects model for repeated measure||||
1598726|NCT02875366|2937526|Superiority||Least Squares Mean Difference|-1.4||||0.1203|2-Sided|95.0|-3.1|0.4|||Mixed effects model for repeated measure||||
1598727|NCT02875366|2937527|Superiority||Least Squares Mean Difference|-15.3||||0.2328|2-Sided|95.0|-40.8|10.1|||Mixed effects model for repeated measure||||
1598728|NCT02875366|2937528|Superiority||Least Squares Mean Difference|-3.2||||0.1894|2-Sided|95.0|-8.0|1.6|||Mixed effects model for repeated measure||||
1598729|NCT02875366|2937529|Superiority||Least Squares Mean Difference|-3.2||||0.3021|2-Sided|95.0|-9.2|2.9|||Mixed effects model for repeated measure||||
1598730|NCT02875028|2937549|Superiority|||||||0.029|||||||Wilcoxon (Mann-Whitney)||||
1598731|NCT02874924|2937554|Equivalence|Pilot study, therefore, no power calculation available.|Mean Difference (Net)|-1.81||||0.56|2-Sided|95.0|-8.48|4.86|||t-test, 2 sided|||Null hypothesis|
1598732|NCT02874794|2937557|Superiority||Mean Difference (Final Values)|-1.97||||0.0242|2-Sided|95.0|-3.68|-0.26|||ANCOVA||||
1598733|NCT02874794|2937558|Superiority||Median Difference (Final Values)|-1.58||||0.0452|2-Sided|95.0|-3.13|-0.03|||ANCOVA||||
1598734|NCT02874794|2937559|Superiority||Mean Difference (Final Values)|0.0||||0.8215|2-Sided|95.0|-0.05|0.04|||ANCOVA||||
1598735|NCT02874794|2937560|Superiority||Median Difference (Final Values)|0.63||||0.2354|2-Sided|95.0|-0.41|1.68|||ANCOVA||||
1598736|NCT02874794|2937561|Superiority||Median Difference (Final Values)|-1.75||||0.0007|2-Sided|95.0|-2.76|-0.75|||ANCOVA|||vs Enalapril|
1598737|NCT02874794|2937562|Superiority||Median Difference (Final Values)|-0.03||||0.8617|2-Sided|95.0|-0.33|0.27|||ANCOVA||||
1598738|NCT02874794|2937563|Superiority||Mean Difference (Final Values)|-2.8|||<|0.0001|2-Sided|95.0|-4.02|-1.59|||ANCOVA||||
1598739|NCT02874794|2937564|Superiority||Mean Difference (Final Values)|-0.13||||0.5792|2-Sided|95.0|-0.58|0.33|||ANCOVA||||
1598740|NCT02874794|2937565|Superiority||Ratio of Geometric Means|0.6667|||<|0.0001|2-Sided|95.0|0.5858|0.7589|||ANCOVA||||
1598741|NCT02874794|2937568|Superiority||Median Difference (Final Values)|-2.2||||0.7827|2-Sided|95.0|-17.6|13.2|||ANCOVA||||
1598742|NCT02873702|2937608|Non-Inferiority|Non-inferiority to lansoprazole if the lower bound of confidence interval (CI) for the treatment difference is greater than -10%.|Difference in Percentage|-2.65|||||2-Sided|95.0|-26.59|21.3||||||Healing Period: Dexlansoprazole 60 mg versus Healing Period: Lansoprazole 30 mg|
1598743|NCT02873689|2937609|Superiority|||||||0.268|||||||Wilcoxon rank-sum test||||
1598744|NCT02873689|2937610|Superiority|||||||0.057|||||||Wilcoxon rank-sum test||||
1598745|NCT02873195|2937635|Superiority|||||||0.4876|||||||Fisher Exact||||
1598746|NCT02873195|2937636|Superiority||Hazard Ratio (HR)|0.94||||0.4|2-Sided|95.0|0.56|1.56|||Log Rank||||
1598747|NCT02873195|2937637|Superiority||Hazard Ratio (HR)|0.725||||0.051|2-Sided|95.0|0.491|1.07|||Log Rank||||
1598748|NCT02872909|2937642|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1598776|NCT02870101|2937721|Other|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.6|||||2-Sided|95.0|99.2|99.8|||||NPA estimated with two-sided 95% score confidence interval.||
1598749|NCT02872909|2937645|Superiority||Mean Difference (Final Values)|1.37|||<|0.05|2-Sided|95.0|0.71|2.54||calculated as <0.05 for 85% power|t-test, 2 sided|Analysed on log transformed data||Sample size requirement estimation - Preliminary data showed pain scores of 1.25 with ambulatory PDT (n=12) and 5.26 (SD 2.38) for conventional PDT (n=50). Estimated that for 85% power to detect as significant at 5% level a difference in mean pain score in one group of 2cm compared with 4 cm in the other group, assuming two-sided testing, a minimum of 45 subjects needed. We aimed for 50 subjects, with an allocation ratio of 2 (twice as many randomised to ambulatory PDT as conventional PDT)|
1598750|NCT02872285|2937664|Superiority|||||||0.4712||||||2-sided p-value|Chi-squared||||
1598751|NCT02872285|2937665|Superiority|||||||0.4712||||||2-sided p-value|Chi-squared||||
1598752|NCT02872285|2937666|Superiority||Mean Difference (Final Values)|-5.34||||0.6695|2-Sided|95.0|-30.87|20.18|||ANCOVA||||
1598753|NCT02872285|2937667|Superiority|||||||0.4712|||||||Chi-squared|2-sided p-value.|||
1598754|NCT02872285|2937668|Superiority||Mean Difference (Final Values)|-12.8||||0.2205|2-Sided|95.0|-33.793|8.199||ANCOVA was used to compare mean percent change in PASI score between baseline and Week 12 between LYC-30937 and placebo treatment groups with treatment as a factor and baseline as a covariate.|ANCOVA|||Subjects included in this analysis had to have both a baseline and Week 12 PASI scores.|
1598755|NCT02871570|2937683|Other||ratio|0.7945|||||2-Sided|90.0|0.5955|1.0599|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.||
1598756|NCT02871570|2937684|Other||ratio|1.2844|||||2-Sided|90.0|1.0732|1.5372|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.||
1598757|NCT02871570|2937685|Other||ratio|0.7776|||||2-Sided|90.0|0.6493|0.9311|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.||
1598758|NCT02871570|2937686|Other||ratio|0.7789|||||2-Sided|90.0|0.6514|0.9313|||||Moderate hepatic impairment group represents the numerator, and normal hepatic function group represents the denominator.||
1598759|NCT02870205|2937714|Superiority|||||||0.002|||||||ANCOVA||||
1598760|NCT02870205|2937714|Superiority||||||<|0.001|||||||ANCOVA||||
1598761|NCT02870205|2937714|Superiority||||||<|0.019|||||||ANCOVA||||
1598762|NCT02870205|2937714|Superiority||||||<|0.028|||||||ANCOVA||||
1598763|NCT02870205|2937714|Superiority||||||<|0.001||||||GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.|ANCOVA||||
1598764|NCT02870101|2937715|Other|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.1|||||2-Sided|95.0|98.6|99.4|||||NPA estimated with two-sided 95% score confidence interval.||
1598765|NCT02870101|2937715|Other|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|83.0|||||2-Sided|95.0|77.6|87.3|||||PPA estimated with two-sided 95% score confidence interval.||
1598766|NCT02870101|2937716|Other|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.8|||||2-Sided|95.0|99.5|99.9|||||NPA estimated with two-sided 95% score confidence interval.||
1598767|NCT02870101|2937716|Other|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|84.0|||||2-Sided|95.0|71.5|91.7|||||PPA estimated with two-sided 95% score confidence interval.||
1598768|NCT02870101|2937717|Other|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.7|||||2-Sided|95.0|98.2|99.1|||||NPA estimated with two-sided 95% score confidence interval.||
1598769|NCT02870101|2937717|Other|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|88.7|||||2-Sided|95.0|83.9|92.3|||||PPA estimated with two-sided 95% score confidence interval.||
1598770|NCT02870101|2937718|Other|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.7|||||2-Sided|95.0|99.4|99.8|||||NPA estimated with two-sided 95% score confidence interval.||
1598771|NCT02870101|2937718|Other|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|88.2|||||2-Sided|95.0|76.6|94.5|||||PPA estimated with two-sided 95% score confidence interval.||
1598772|NCT02870101|2937719|Other|Estimated Negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.3|||||2-Sided|95.0|98.9|99.6|||||NPA estimated with two-sided 95% score confidence interval.||
1598773|NCT02870101|2937719|Other|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|86.0|||||2-Sided|95.0|80.9|89.9|||||PPA estimated with two-sided 95% score confidence interval.||
1598774|NCT02870101|2937720|Other|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.7|||||2-Sided|95.0|99.4|99.8|||||NPA estimated with two-sided 95% score confidence interval.||
1598775|NCT02870101|2937720|Other|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|95.9|||||2-Sided|95.0|86.3|98.9|||||PPA estimated with two-sided 95% score confidence interval.||
1598777|NCT02870101|2937721|Other|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|88.3|||||2-Sided|95.0|83.2|92.0|||||PPA estimated with two-sided 95% score confidence interval.||
1598778|NCT02870101|2937722|Other|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.5|||||2-Sided|95.0|99.2|99.7|||||NPA estimated with two-sided 95% score confidence interval.||
1598779|NCT02870101|2937722|Other|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|84.8|||||2-Sided|95.0|79.4|89.0|||||PPA estimated with two-sided 95% score confidence interval.||
1598780|NCT02870101|2937723|Other|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.2|||||2-Sided|95.0|98.8|99.5|||||NPA estimated with two-sided 95% score confidence interval.||
1598781|NCT02870101|2937723|Other|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|96.5|||||2-Sided|95.0|92.9|98.3|||||PPA estimated with two-sided 95% score confidence interval.||
1598782|NCT02870101|2937724|Other|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Equivocal; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.8|||||2-Sided|95.0|98.3|99.2|||||NPA estimated with two-sided 95% score confidence interval.||
1598783|NCT02870101|2937724|Other|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Equivocal; ASIS Indeterminate + Index Test Negative; ASIS Indeterminate)|PPA|95.1|||||2-Sided|95.0|91.3|97.3|||||PPA estimated with two-sided 95% score confidence interval.||
1598784|NCT02870101|2937725|Other|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|99.6|||||2-Sided|95.0|99.3|99.8|||||NPA estimated with two-sided 95% score confidence interval.||
1598785|NCT02870101|2937725|Other|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|91.2|||||2-Sided|95.0|86.5|94.4|||||PPA estimated with two-sided 95% score confidence interval.||
1598786|NCT02870101|2937726|Other|Estimated negative percent agreement (NPA) defined as: (Index Test Negative; ASIS Negative) / (Index Test Negative; ASIS Negative + Index Test Positive; ASIS Negative + Index Test Positive; ASIS Indeterminate)|NPA|98.8|||||2-Sided|95.0|98.2|99.1|||||NPA estimated with two-sided 95% score confidence interval.||
1598787|NCT02870101|2937726|Other|Estimated positive percent agreement (PPA) defined as: (Index Test Positive; ASIS Positive) / (Index Test Negative; ASIS Positive + Index Test Positive; ASIS Positive + Index Test Negative; ASIS Indeterminate)|PPA|94.7|||||2-Sided|95.0|90.7|97.0|||||PPA estimated with two-sided 95% score confidence interval.||
1598788|NCT02869438|2937748|Superiority||Odds Ratio (OR)|2.51||||0.0107|2-Sided|95.0|1.24|5.09|||Regression, Logistic|Model includes covariates of treatment, region.|For Day 84|Responder analysis: responder is defined as Very much improved, improved, and minimally improved.|
1598789|NCT02869438|2937749|Superiority||Odds Ratio (OR)|2.97||||0.0018|2-Sided|95.0|1.5|5.88|||Regression, Logistic|Model includes covariates of treatment, region.|For Day 84|Responder analysis: responder is defined as Very much improved, improved, and minimally improved.|
1598790|NCT02869438|2937750|Superiority||Mean Difference (Final Values)|-0.365||||0.012|2-Sided|95.0|-0.649|-0.081|||Mixed Models Analysis|Model includes covariates of treatment, baseline PGI-S score, region, visit, treatment by visit interaction.|For Day 84||
1598791|NCT02869438|2937760|Superiority||Mean Difference (Final Values)|5.414||||0.2825|2-Sided|95.0|-4.492|15.321|||Mixed Models Analysis|Model includes covariates of treatment, baseline FeNO value, region, visit, treatment by visit interaction.|||
1598792|NCT02869438|2937761|Superiority||Mean Difference (Final Values)|-7.257||||0.0003|2-Sided|95.0|-11.133|-3.38|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.||
1598793|NCT02869438|2937761|Superiority||Mean Difference (Final Values)|-8.599||||0.0004|2-Sided|95.0|-13.3|-3.898|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 84||
1598794|NCT02869438|2937761|Superiority||Mean Difference (Final Values)|-5.942||||0.0115|2-Sided|95.0|-10.538|-1.346|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 56||
1598795|NCT02869438|2937761|Superiority||Mean Difference (Final Values)|-7.229||||0.0001|2-Sided|95.0|-10.832|-3.626|||Mixed Models Analysis|Model includes covariates of treatment, baseline SGRQ score, region, visit, treatment by visit interaction.|For Day 28||
1598796|NCT02869438|2937762|Superiority||Mean Difference (Final Values)|-0.395||||0.0002|2-Sided|95.0|-0.603|-0.188|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.||
1598797|NCT02869438|2937762|Superiority||Mean Difference (Final Values)|-0.472||||0.0004|2-Sided|95.0|-0.731|-0.213|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 84||
1598798|NCT02869438|2937762|Superiority||Mean Difference (Final Values)|-0.312||||0.0117|2-Sided|95.0|-0.554|-0.07|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 56||
1598799|NCT02869438|2937762|Superiority||Mean Difference (Final Values)|-0.402||||0.0002|2-Sided|95.0|-0.609|-0.195|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 28||
1598852|NCT02863575|2937881|Superiority||||||<|0.861|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.|||
1598800|NCT02869438|2937762|Superiority||Mean Difference (Final Values)|-0.293||||0.0024|2-Sided|95.0|-0.481|-0.105|||Mixed Models Analysis|Model includes covariates of treatment, baseline ACQ-6 score, region, visit, treatment by visit interaction.|For Day 14||
1598801|NCT02869438|2937763|Superiority||Odds Ratio (OR)|1.33||||0.3017|2-Sided|95.0|0.77|2.29|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 84||
1598802|NCT02869438|2937763|Superiority||Odds Ratio (OR)|1.3||||0.3271|2-Sided|95.0|0.77|2.21|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 56||
1598803|NCT02869438|2937763|Superiority||Odds Ratio (OR)|1.57||||0.1052|2-Sided|95.0|0.91|2.71|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 28||
1598804|NCT02869438|2937763|Superiority||Odds Ratio (OR)|1.58||||0.0924|2-Sided|95.0|0.93|2.7|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 14||
1598805|NCT02869438|2937763|Superiority||Odds Ratio (OR)|1.29||||0.34|2-Sided|95.0|0.76|2.19|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 7||
1598806|NCT02869438|2937763|Superiority||Odds Ratio (OR)|1.49||||0.1604|2-Sided|95.0|0.85|2.58|||Regression, Logistic|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 3||
1598807|NCT02869438|2937764|Superiority||Mean Difference (Final Values)|0.063||||0.1377|2-Sided|95.0|-0.02|0.147|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For average of Day 28, 56, 84.||
1598808|NCT02869438|2937764|Superiority||Mean Difference (Final Values)|0.092||||0.0595|2-Sided|95.0|-0.004|0.188|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 84||
1598809|NCT02869438|2937764|Superiority||Mean Difference (Final Values)|0.023||||0.6536|2-Sided|95.0|-0.077|0.122|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 56||
1598810|NCT02869438|2937764|Superiority||Mean Difference (Final Values)|0.075||||0.0976|2-Sided|95.0|-0.014|0.164|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 28||
1598811|NCT02869438|2937764|Superiority||Mean Difference (Final Values)|0.015||||0.7252|2-Sided|95.0|-0.068|0.098|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 14||
1598812|NCT02869438|2937764|Superiority||Mean Difference (Final Values)|0.041||||0.2734|2-Sided|95.0|-0.033|0.115|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 7||
1598813|NCT02869438|2937764|Superiority||Mean Difference (Final Values)|0.006||||0.8667|2-Sided|95.0|-0.062|0.073|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FVC, region, visit, treatment by visit interaction.|For Day 3||
1598814|NCT02869438|2937765|Superiority||Mean Difference (Final Values)|0.026||||0.4959|2-Sided|95.0|-0.049|0.101|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 14||
1598815|NCT02869438|2937765|Superiority||Mean Difference (Final Values)|0.046||||0.148|2-Sided|95.0|-0.016|0.109|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 7||
1598816|NCT02869438|2937765|Superiority||Mean Difference (Final Values)|0.015||||0.6384|2-Sided|95.0|-0.049|0.08|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 3||
1598817|NCT02869438|2937766|Superiority||Mean Difference (Final Values)|-101.0|||<|0.0001|2-Sided|95.0|-118.9|-83.06|||Mixed Models Analysis|Model includes covariates of treatment, baseline eosinophils counts, region, visit, treatment by visit interaction.|||
1598818|NCT02869438|2937767|Superiority||Mean Difference (Final Values)|-0.176||||0.2847|2-Sided|95.0|-0.505|0.153|||Mixed Models Analysis|Model includes covariates of treatment, baseline RV, region, visit, treatment by visit interaction.|||
1598819|NCT02869438|2937768|Superiority||Mean Difference (Final Values)|0.057||||0.1558|2-Sided|95.0|-0.022|0.135|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For average over Day 28, 56, and 84||
1598820|NCT02869438|2937768|Superiority||Mean Difference (Final Values)|0.079||||0.0969|2-Sided|95.0|-0.014|0.173|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 84||
1598821|NCT02869438|2937768|Superiority||Mean Difference (Final Values)|0.013||||0.7747|2-Sided|95.0|-0.077|0.104|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 56||
1598822|NCT02869438|2937768|Superiority||Mean Difference (Final Values)|0.077||||0.0707|2-Sided|95.0|-0.007|0.161|||Mixed Models Analysis|Model includes covariates of treatment, baseline pre-BD FEV1, region, visit, treatment by visit interaction.|For Day 28||
1598823|NCT02868554|2937774|Superiority||Mean Difference (Final Values)|0.05||||0.02|2-Sided||||||ANOVA||||
1598824|NCT02868554|2937775|Superiority||Mean Difference (Final Values)|0.05||||0.07|2-Sided||||||ANOVA||||
1598825|NCT02868216|2937785|Other||Mean Difference (Final Values)|2.3|Standard Deviation|0.84||0.05|2-Sided|95.0|0.63|3.98|||ANOVA||||
1598826|NCT02867709|2937790|Superiority||Odds Ratio (OR)|1.12||||0.9522|2-Sided|95.0|0.83|1.51||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.|||
1598827|NCT02867709|2937790|Superiority||Odds Ratio (OR)|1.1||||0.9522|2-Sided|95.0|0.81|1.49||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.|||
1598853|NCT02863575|2937882|Superiority||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.|||
1598828|NCT02867709|2937791|Superiority||Odds Ratio (OR)|1.39||||0.044|2-Sided|95.0|1.05|1.84||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.|||
1598829|NCT02867709|2937791|Superiority||Odds Ratio (OR)|1.38||||0.1066|2-Sided|95.0|1.04|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.|||
1598830|NCT02867709|2937792|Superiority||Odds Ratio (OR)|1.52||||0.0167|2-Sided|95.0|1.14|2.02||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.|||
1598831|NCT02867709|2937792|Superiority||Odds Ratio (OR)|1.28||||0.1833|2-Sided|95.0|0.96|1.72||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.|||
1598832|NCT02867709|2937793|Superiority||Odds Ratio (OR)|1.85||||0.0129|2-Sided|95.0|1.2|2.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1598833|NCT02867709|2937793|Superiority||Odds Ratio (OR)|1.62||||0.0711|2-Sided|95.0|1.04|2.53||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1598834|NCT02867709|2937794|Superiority||Odds Ratio (OR)|2.16||||0.0129|2-Sided|95.0|1.59|2.92||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1598835|NCT02867709|2937794|Superiority||Odds Ratio (OR)|1.82||||0.0711|2-Sided|95.0|1.33|2.48||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1598836|NCT02867709|2937795|Superiority||Odds Ratio (OR)|1.77||||0.0129|2-Sided|95.0|1.35|2.32||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1598837|NCT02867709|2937795|Superiority||Odds Ratio (OR)|1.65||||0.0711|2-Sided|95.0|1.25|2.17||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1598838|NCT02867709|2937796|Superiority||Odds Ratio (OR)|1.65||||0.0129|2-Sided|95.0|1.25|2.2||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.|||
1598839|NCT02867709|2937796|Superiority||Odds Ratio (OR)|1.37||||0.0711|2-Sided|95.0|1.02|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.|||
1598840|NCT02867709|2937797|Superiority||Odds Ratio (OR)|1.62||||0.0129|2-Sided|95.0|1.14|2.29||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1598841|NCT02867709|2937797|Superiority||Odds Ratio (OR)|1.56||||0.0285|2-Sided|95.0|1.09|2.22||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1598842|NCT02867202|2937798|Other||||||<|0.05|||||||t-test, 2 sided|||Data analysis was performed with SPSS version 22.0, using two-sided test, and a p value < 0.05 was considered statistically significant.|
1598843|NCT02866942|2937804|Other|||||||0.26|||||||McNemar||||
1598844|NCT02864706|2937858|Superiority|||||||0.037|||||||Cochran-Mantel-Haenszel||||
1598845|NCT02864706|2937859|Superiority|||||||0.0043|||||||ANCOVA|Incidence of CAV at 5-7 yrs was compared between groups using Cochran-Mantel-Haenszel test with stratification according to baseline distribution|||
1598846|NCT02864342|2937865|Other||||||<|0.001|||||||Satterthwaite t-test|||The effect of medication reminders on Symbicort adherence was evaluated using a t-test. The equality of variances was also tested and as the variances were not equal, the Satterthwaite-t test was reported.|
1598847|NCT02863575|2937880|Superiority||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.|||
1598848|NCT02863575|2937880|Superiority||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.|||
1598849|NCT02863575|2937880|Superiority||||||<|0.838|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.|||
1598850|NCT02863575|2937881|Superiority||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.|||
1598851|NCT02863575|2937881|Superiority||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.|||
1598854|NCT02863575|2937882|Superiority||||||<|0.001|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.|||
1598855|NCT02863575|2937882|Superiority||||||<|0.028|||||||Gehan-Wilcoxon test|P-value was calculated using the Gehan-Wilcoxon test, stratified by gender and baseline categorical pain severity terms.|||
1598856|NCT02863575|2937883|Superiority||LS means difference|1.91|||<|0.001|2-Sided|95.0|1.0|2.82|||ANCOVA|||PID score at 8 hour|
1598857|NCT02863575|2937883|Superiority||LS means difference|2.09|||<|0.001|2-Sided|95.0|1.18|3.0|||ANCOVA|||PID score at 8 hour|
1598858|NCT02863575|2937883|Superiority||LS means difference|0.18|||<|0.581|2-Sided|95.0|-0.46|0.82|||ANCOVA|||PID score at 8 hour|
1598859|NCT02863575|2937883|Superiority||LS means difference|2.29|||<|0.001|2-Sided|95.0|1.4|3.18|||ANCOVA|||PID score at 7 hour|
1598860|NCT02863575|2937883|Superiority||LS means difference|2.42|||<|0.001|2-Sided|95.0|1.53|3.31|||ANCOVA|||PID score at 7 hour|
1598861|NCT02863575|2937883|Superiority||LS means difference|0.14|||<|0.669|2-Sided|95.0|-0.49|0.76|||ANCOVA|||PID score at 7 hour|
1598862|NCT02863575|2937883|Superiority||LS means difference|2.9|||<|0.001|2-Sided|95.0|2.06|3.74|||ANCOVA|||PID score at 6 hour|
1598863|NCT02863575|2937883|Superiority||LS means difference|3.29|||<|0.001|2-Sided|95.0|2.44|4.13|||ANCOVA|||PID score at 6 hour|
1598864|NCT02863575|2937883|Superiority||LS means difference|0.39|||<|0.195|2-Sided|95.0|-0.2|0.98|||ANCOVA|||PID score at 6 hour|
1598865|NCT02863575|2937883|Superiority||LS means difference|3.48|||<|0.001|2-Sided|95.0|2.69|4.27|||ANCOVA|||PID score at 5 hour|
1598866|NCT02863575|2937883|Superiority||LS means difference|3.74|||<|0.001|2-Sided|95.0|2.95|4.53|||ANCOVA|||PID score at 5 hour|
1598867|NCT02863575|2937883|Superiority||LS means difference|0.26|||<|0.361|2-Sided|95.0|-0.3|0.81|||ANCOVA|||PID score at 5 hour|
1598868|NCT02863575|2937883|Superiority||LS means difference|4.05|||<|0.001|2-Sided|95.0|3.32|4.79|||ANCOVA|||PID score at 4 hour|
1598869|NCT02863575|2937883|Superiority||LS means difference|4.14|||<|0.001|2-Sided|95.0|3.4|4.87|||ANCOVA|||PID score at 4 hour|
1598870|NCT02863575|2937883|Superiority||LS means difference|0.08|||<|0.75|2-Sided|95.0|-0.43|0.6|||ANCOVA|||PID score at 4 hour|
1598871|NCT02863575|2937883|Superiority||LS means difference|4.34|||<|0.001|2-Sided|95.0|3.65|5.03|||ANCOVA|||PID score at 3 hour|
1598872|NCT02863575|2937883|Superiority||LS means difference|4.66|||<|0.001|2-Sided|95.0|3.98|5.35|||ANCOVA|||PID score at 3 hour|
1598873|NCT02863575|2937883|Superiority||LS means difference|0.32|||<|0.186|2-Sided|95.0|-0.16|0.81|||ANCOVA|||PID score at 3 hour|
1598874|NCT02863575|2937883|Superiority||LS means difference|4.78|||<|0.001|2-Sided|95.0|4.1|5.45|||ANCOVA|||PID score at 2 hour|
1598875|NCT02863575|2937883|Superiority||LS means difference|5.22|||<|0.001|2-Sided|95.0|4.54|5.89|||ANCOVA|||PID score at 2 hour|
1598876|NCT02863575|2937883|Superiority||LS means difference|0.44|||<|0.066|2-Sided|95.0|-0.03|0.91|||ANCOVA|||PID score at 2 hour|
1598877|NCT02863575|2937883|Superiority||LS means difference|4.44|||<|0.001|2-Sided|95.0|3.76|5.12|||ANCOVA|||PID score at 1.5 hour|
1598878|NCT02863575|2937883|Superiority||LS means difference|5.03|||<|0.001|2-Sided|95.0|4.35|5.71|||ANOVA|||PID score at 1.5 hour|
1598879|NCT02863575|2937883|Superiority||LS means difference|0.59|||<|0.015|2-Sided|95.0|0.11|1.06|||ANCOVA|||PID score at 1.5 hour|
1598880|NCT02863575|2937883|Superiority||LS means difference|3.6|||<|0.001|2-Sided|95.0|2.92|4.29|||ANCOVA|||PID score at 1 hour|
1598881|NCT02863575|2937883|Superiority||LS means difference|4.1|||<|0.001||95.0|3.41|4.78|||ANCOVA|||PID score at 1 hour|
1598882|NCT02863575|2937883|Superiority||LS means difference|0.49|||<|0.045|2-Sided|95.0|0.01|0.97|||ANCOVA|||PID score at 1 hour|
1598883|NCT02863575|2937883|Superiority||LS means difference|1.55|||<|0.001|2-Sided|95.0|0.91|2.2|||ANCOVA|||PID score at 0.5 hour|
1598884|NCT02863575|2937883|Superiority||LS means difference|1.45|||<|0.001|2-Sided|95.0|0.81|2.1|||ANCOVA|||PID score at 0.5 hour|
1598885|NCT02863575|2937883|Superiority||LS means difference|-0.1|||<|0.654|2-Sided|95.0|-0.55|0.35|||ANCOVA|||PID score at 0.5 hour|
1598886|NCT02863575|2937883|Superiority||LS means difference|0.07|||<|0.676|2-Sided|95.0|-0.27|0.42|||ANCOVA|||PID score at 0.25 hr|
1598887|NCT02863575|2937883|Superiority||LS means difference|0.04|||<|0.804|2-Sided|95.0|-0.3|0.39|||ANCOVA|||PID score at 0.25 hour|
1598888|NCT02863575|2937883|Superiority||LS means difference|-0.03|||<|0.808|2-Sided|95.0|-0.27|0.21|||ANCOVA|||PID score at 0.25 hour|
1598889|NCT02863575|2937884|Superiority||LS means difference|0.93|||<|0.001|2-Sided|95.0|0.5|1.35|||ANCOVA|||PRR score at 8 hour|
1598890|NCT02863575|2937884|Superiority||LS means difference|0.93|||<|0.001|2-Sided|95.0|0.5|1.36|||ANCOVA|||PRR score at 8 hour|
1598891|NCT02863575|2937884|Superiority||LS means difference|0.0|||<|0.98||95.0|-0.3|0.3|||ANCOVA|||PRR score at 8 hour|
1598892|NCT02863575|2937884|Superiority||LS means difference|1.13|||<|0.001|2-Sided|95.0|0.72|1.55|||ANCOVA|||PRR score at 7 hour|
1598893|NCT02863575|2937884|Superiority||LS means difference|1.1|||<|0.001|2-Sided|95.0|0.69|1.52|||ANCOVA|||PRR score at 7 hour|
1598894|NCT02863575|2937884|Superiority||LS means difference|-0.03|||<|0.841|2-Sided|95.0|-0.32|0.26|||ANCOVA|||PRR score at 7 hour|
1598895|NCT02863575|2937884|Superiority||LS means difference|1.4|||<|0.001|2-Sided|95.0|1.01|1.79|||ANCOVA|||PRR score at 6 hour|
1598896|NCT02863575|2937884|Superiority||LS means difference|1.51|||<|0.001|2-Sided|95.0|1.12|1.9|||ANCOVA|||PRR score at 6 hour|
1598897|NCT02863575|2937884|Superiority||LS means difference|0.11|||<|0.425|2-Sided|94.0|-0.16|0.38|||ANCOVA|||PRR score at 6 hour|
1598898|NCT02863575|2937884|Superiority||LS means difference|1.67|||<|0.001|2-Sided|95.0|1.31|2.03|||ANCOVA|||PRR score at 5 hour|
1598899|NCT02863575|2937884|Superiority||LS means difference|1.73|||<|0.001|2-Sided|95.0|1.36|2.09|||ANCOVA|||PRR score at 5 hour|
1598900|NCT02863575|2937884|Superiority||LS means difference|0.06|||<|0.656|2-Sided|95.0|-0.19|0.31|||ANCOVA|||PRR score at 5 hour|
1598901|NCT02863575|2937884|Superiority||LS means difference|1.94|||<|0.001|2-Sided|95.0|1.61|2.28|||ANCOVA|||PRR score at 4 hour|
1598902|NCT02863575|2937884|Superiority||LS means difference|1.94|||<|0.001|2-Sided|95.0|1.61|2.28|||ANCOVA|||PRR score at 4 hour|
1598903|NCT02863575|2937884|Superiority||LS means difference|0.0|||<|0.997|2-Sided|95.0|-0.23|0.23|||ANCOVA|||PRR score at 4 hour|
1598904|NCT02863575|2937884|Superiority||LS means difference|2.08|||<|0.001|2-Sided|95.0|1.78|2.38|||ANCOVA|||PRR score at 3 hour|
1598905|NCT02863575|2937884|Superiority||LS means difference|2.16|||<|0.001|2-Sided|95.0|1.86|2.47|||ANCOVA|||PRR score at 3 hour|
1598906|NCT02863575|2937884|Superiority||LS means difference|0.08|||<|0.448|2-Sided|95.0|-0.13|0.29|||ANCOVA|||PRR score at 3 hour|
1598907|NCT02863575|2937884|Superiority||LS means difference|2.22|||<|0.001|2-Sided|95.0|1.91|2.53|||ANCOVA|||PRR score at 2 hour|
1598908|NCT02863575|2937884|Superiority||LS means difference|2.4|||<|0.001|2-Sided|95.0|2.09|2.71|||ANCOVA|||PRR score at 2 hour|
1598909|NCT02863575|2937884|Superiority||LS means difference|0.18|||<|0.103|2-Sided|95.0|-0.04|0.4|||ANCOVA|||PRR score at 2 hour|
1598910|NCT02863575|2937884|Superiority||LS means difference|2.08|||<|0.001|2-Sided|95.0|1.77|2.39|||ANCOVA|||PRR score at 1.5 hour|
1598911|NCT02863575|2937884|Superiority||LS means difference|2.33|||<|0.001|2-Sided|95.0|2.02|2.64|||ANCOVA|||PRR score at 1.5 hour|
1598912|NCT02863575|2937884|Superiority||LS means difference|0.25|||<|0.024|2-Sided|95.0|0.03|0.47|||ANCOVA|||PRR score at 1.5 hour|
1598913|NCT02863575|2937884|Superiority||LS means difference|1.78|||<|0.001|2-Sided|95.0|1.46|2.09|||ANCOVA|||PRR score at 1 hour|
1598914|NCT02863575|2937884|Superiority||LS means difference|2.01|||<|0.001|2-Sided|95.0|1.69|2.33|||ANCOVA|||PRR score at 1 hour|
1598915|NCT02863575|2937884|Superiority||LS means difference|0.24|||<|0.038|2-Sided|95.0|0.01|0.46|||ANCOVA|||PRR score at 1 hour|
1598916|NCT02863575|2937884|Superiority||LS means difference|0.74|||<|0.001|2-Sided|95.0|0.42|1.05|||ANCOVA|||PRR score at 0.5 hour|
1598917|NCT02863575|2937884|Superiority||LS means difference|0.81|||<|0.001|2-Sided|95.0|0.49|1.12|||ANCOVA|||PRR score at 0.5 hour|
1598918|NCT02863575|2937884|Superiority||LS means difference|0.07|||<|0.543|2-Sided|95.0|-0.15|0.29|||ANCOVA|||PRR score at 0.5 hour|
1598919|NCT02863575|2937884|Superiority||LS means difference|0.04|||<|0.686|2-Sided|95.0|-0.14|0.22|||ANCOVA|||PRR score at 0.25 hour|
1598920|NCT02863575|2937884|Superiority||LS means difference|0.07|||<|0.426|2-Sided|95.0|-0.11|0.25|||ANCOVA|||PRR score at 0.25 hour|
1598921|NCT02863575|2937884|Superiority||LS means difference|0.04|||<|0.575|2-Sided|94.0|-0.09|0.16|||ANCOVA|||PRR score at 0.25 hour|
1598922|NCT02863575|2937885|Superiority||LS means difference|2.83|||<|0.001|2-Sided|95.0|1.51|4.16|||ANCOVA|||PRID at 8 hour|
1598923|NCT02863575|2937885|Superiority||LS means difference|3.02|||<|0.001|2-Sided|95.0|1.69|4.34|||ANCOVA|||PRID at 8 hour|
1598924|NCT02863575|2937885|Superiority||LS means difference|0.18|||<|0.698|2-Sided|95.0|-0.74|1.11|||ANCOVA|||PRID at 8 hour|
1598925|NCT02863575|2937885|Superiority||LS means difference|3.42|||<|0.001|2-Sided|95.0|2.12|4.71|||ANCOVA|||PRID at 7 hour|
1598926|NCT02863575|2937885|Superiority||LS means difference|3.53|||<|0.001|2-Sided|95.0|2.23|4.82|||ANCOVA|||PRID at 7 hour|
1598927|NCT02863575|2937885|Superiority||LS means difference|0.11|||<|0.818|2-Sided|95.0|-0.8|1.01|||ANCOVA|||PRID at 7 hour|
1598928|NCT02863575|2937885|Superiority||LS means difference|4.3|||<|0.001|2-Sided|95.0|3.08|5.52|||ANCOVA|||PRID at 6 hour|
1598929|NCT02863575|2937885|Superiority||LS means difference|4.8|||<|0.001|2-Sided|95.0|3.58|6.02|||ANCOVA|||PRID at 6 hour|
1598930|NCT02863575|2937885|Superiority||LS means difference|0.5|||<|0.25|2-Sided|95.0|-0.35|1.35|||ANCOVA|||PRID at 6 hour|
1598931|NCT02863575|2937885|Superiority||LS means difference|5.15|||<|0.001|2-Sided|95.0|4.01|6.29|||ANCOVA|||PRID at 5 hour|
1598932|NCT02863575|2937885|Superiority||LS means difference|5.47|||<|0.001|2-Sided|95.0|4.33|6.6|||ANCOVA|||PRID at 5 hour|
1598933|NCT02863575|2937885|Superiority||LS means difference|0.31|||<|0.438|2-Sided|95.0|-0.48|1.11|||ANCOVA|||PRID at 5 hour|
1598934|NCT02863575|2937885|Superiority||LS means difference|6.0|||<|0.001|2-Sided|95.0|4.94|7.05|||ANCOVA|||PRID at 4 hour|
1598935|NCT02863575|2937885|Superiority||LS means difference|6.08|||<|0.001|2-Sided|95.0|5.02|7.14|||ANCOVA|||PRID at 4 hour|
1598936|NCT02863575|2937885|Superiority||LS means difference|0.08|||<|0.823|2-Sided|95.0|-0.65|0.82|||ANCOVA|||PRID at 4 hour|
1598937|NCT02863575|2937885|Superiority||LS means difference|6.42|||<|0.001|2-Sided|95.0|5.44|7.4|||ANCOVA|||PRID at 3 hour|
1598938|NCT02863575|2937885|Superiority||LS means difference|6.83|||<|0.001|2-Sided|95.0|5.85|7.8|||ANCOVA|||PRID at 3 hour|
1598939|NCT02863575|2937885|Superiority||LS means difference|0.41|||<|0.243|2-Sided|95.0|-0.28|1.09|||ANCOVA|||PRID at 3 hour|
1598940|NCT02863575|2937885|Superiority||LS means difference|6.99|||<|0.001|2-Sided|95.0|6.03|7.96|||ANCOVA|||PRID at 2 hour|
1598941|NCT02863575|2937885|Superiority||LS means difference|7.62|||<|0.001|2-Sided|95.0|6.65|8.58|||ANCOVA|||PRID at 2 hour|
1598942|NCT02863575|2937885|Superiority||LS means difference|0.62|||<|0.071|2-Sided|95.0|-0.05|1.3|||ANCOVA|||PRID at 2 hour|
1598943|NCT02863575|2937885|Superiority||LS means difference|6.52|||<|0.001|2-Sided|95.0|5.55|7.49|||ANCOVA|||PRID at 1.5 hour|
1598944|NCT02863575|2937885|Superiority||LS means difference|7.36|||<|0.001|2-Sided|95.0|6.39|8.33|||ANCOVA|||PRID at 1.5 hour|
1598945|NCT02863575|2937885|Superiority||LS means difference|0.84|||<|0.015|2-Sided|95.0|0.16|1.52|||ANCOVA|||PRID at 1.5 hour|
1598946|NCT02863575|2937885|Superiority||LS means difference|5.38|||<|0.001|2-Sided|95.0|4.39|6.37|||ANCOVA|||PRID at 1 hour|
1598947|NCT02863575|2937885|Superiority||LS means difference|6.11|||<|0.001|2-Sided|95.0|5.12|7.1|||ANCOVA|||PRID at 1 hour|
1598948|NCT02863575|2937885|Superiority||LS means difference|0.73|||<|0.039|2-Sided|95.0|0.04|1.42|||ANCOVA|||PRID at 1 hour|
1599067|NCT02858401|2938162|Other|||||||0.223|||||||Wilcoxon rank sum test||||
1598949|NCT02863575|2937885|Superiority||LS means difference|2.29|||<|0.001|2-Sided|95.0|1.35|3.24|||ANCOVA|||PRID at 0.5 hour|
1598950|NCT02863575|2937885|Superiority||LS means difference|2.26|||<|0.001|2-Sided|95.0|1.31|3.2|||ANCOVA|||PRID at 0.5 hour|
1598951|NCT02863575|2937885|Superiority||LS means difference|-0.04|||<|0.917|2-Sided|95.0|-0.7|0.63|||ANCOVA|||PRID at 0.5 hour|
1598952|NCT02863575|2937885|Superiority||LS means difference|0.11|||<|0.67|2-Sided|95.0|-0.4|0.62|||ANCOVA|||PRID at 0.25 hour|
1598953|NCT02863575|2937885|Superiority||LS means difference|0.12|||<|0.654|2-Sided|95.0|-0.4|0.63|||ANCOVA|||PRID at 0.25 hour|
1598954|NCT02863575|2937885|Superiority||LS means difference|0.01|||<|0.975|2-Sided|95.0|-0.35|0.36|||ANCOVA|||PRID at 0.25 hour|
1598955|NCT02863575|2937886|Superiority||LS means difference|12.38|||<|0.001|2-Sided|95.0|10.08|14.68|||ANCOVA|||TOTPAR 0-8|
1598956|NCT02863575|2937886|Superiority||LS means difference|12.96|||<|0.001|2-Sided|95.0|10.66|15.26|||ANCOVA|||TOTPAR 0-8|
1598957|NCT02863575|2937886|Superiority||LS means difference|0.58|||<|0.476|2-Sided|95.0|-1.03|2.19|||ANCOVA|||TOTPAR 0-8|
1598958|NCT02863575|2937886|Superiority||LS means difference|10.32|||<|0.001|2-Sided|95.0|8.69|11.95|||ANCOVA|||TOTPAR 0-6|
1598959|NCT02863575|2937886|Superiority||LS means difference|10.93|||<|0.001|2-Sided|95.0|9.3|12.56|||ANCOVA|||TOTPAR 0-6|
1598960|NCT02863575|2937886|Superiority||LS means difference|0.61|||<|0.293|2-Sided|95.0|-0.53|1.75|||ANCOVA|||TOTPAR 0-6|
1598961|NCT02863575|2937886|Superiority||LS means difference|7.25|||<|0.001|2-Sided|95.0|6.23|8.27|||ANCOVA|||TOTPAR 0-4|
1598962|NCT02863575|2937886|Superiority||LS means difference|7.69|||<|0.001|2-Sided|95.0|6.68|8.71|||ANCOVA|||TOTPAR 0-4|
1598963|NCT02863575|2937886|Superiority||LS means difference|0.44|||<|0.224|2-Sided|95.0|-0.27|1.15|||ANCOVA|||TOTPAR 0-4|
1598964|NCT02863575|2937886|Superiority||LS means difference|3.23|||<|0.001|2-Sided|95.0|2.73|3.73|||ANCOVA|||TOTPAR 0-2|
1598965|NCT02863575|2937886|Superiority||LS means difference|3.59|||<|0.001|2-Sided|95.0|3.09|4.09|||ANCOVA|||TOTPAR 0-2|
1598966|NCT02863575|2937886|Superiority||LS means difference|0.36|||<|0.044|2-Sided|95.0|0.01|0.71|||ANCOVA|||TOTPAR 0-2|
1598967|NCT02863575|2937887|Superiority||LS means difference|25.79|||<|0.001|2-Sided|95.0|20.68|30.89|||ANCOVA|||SPID 0-8|
1598968|NCT02863575|2937887|Superiority||LS means difference|27.88|||<|0.001|2-Sided|95.0|22.78|32.99|||ANCOVA|||SPID 0-8|
1598969|NCT02863575|2937887|Superiority||LS means difference|2.1|||<|0.249|2-Sided|95.0|-1.47|5.67|||ANCOVA|||SPID 0-8|
1598970|NCT02863575|2937887|Superiority||LS means difference|21.59|||<|0.001|2-Sided|95.0|17.93|25.25|||ANCOVA|||SPID 0-6|
1598971|NCT02863575|2937887|Superiority||LS means difference|23.37|||<|0.001|2-Sided|95.0|19.71|27.03|||ANCOVA|||SPID 0-6|
1598972|NCT02863575|2937887|Superiority||LS means difference|1.78|||<|0.172|2-Sided|95.0|-0.78|4.34|||ANCOVA|||SPID 0-6|
1598973|NCT02863575|2937887|Superiority||LS means difference|15.21|||<|0.001|2-Sided|95.0|12.91|17.51|||ANCOVA|||SPID 0-4|
1598974|NCT02863575|2937887|Superiority||LS means difference|16.35|||<|0.001|2-Sided|95.0|14.05|18.64|||ANCOVA|||SPID 0-4|
1598975|NCT02863575|2937887|Superiority||LS means difference|1.14|||<|0.165|2-Sided|95.0|-0.47|2.74|||ANCOVA|||SPID 0-4|
1598976|NCT02863575|2937887|Superiority||LS means difference|6.82|||<|0.001|2-Sided|95.0|5.71|7.93|||ANCOVA|||SPID 0-2|
1598977|NCT02863575|2937887|Superiority||LS means difference|7.55|||<|0.001|2-Sided|95.0|6.44|8.66|||ANCOVA|||SPID 0-2|
1598978|NCT02863575|2937887|Superiority||LS means difference|0.73|||<|0.066|2-Sided|95.0|-0.05|1.5|||ANCOVA|||SPID 0-2|
1598979|NCT02863575|2937888|Superiority||LS mean difference|38.17|||<|0.001|2-Sided|95.0|30.81|45.52|||ANCOVA|||SPRID 0-8|
1598980|NCT02863575|2937888|Superiority||LS mean difference|40.85|||<|0.001|2-Sided|95.0|33.49|48.2|||ANCOVA|||SPRID 0-8|
1598981|NCT02863575|2937888|Superiority||LS mean difference|31.91|||<|0.001|2-Sided|95.0|26.67|37.16|||ANCOVA|||SPRID 0-6|
1598982|NCT02863575|2937888|Superiority||LS mean difference|34.3|||<|0.001|2-Sided|95.0|29.06|39.55|||ANCOVA|||SPRID 0-6|
1598983|NCT02863575|2937888|Superiority||LS mean difference|2.39|||<|0.201|2-Sided|95.0|-1.28|6.06|||ANCOVA|||SPRID 0-6|
1598984|NCT02863575|2937888|Superiority||LS mean difference|22.46|||<|0.001|2-Sided|95.0|19.18|25.75|||ANCOVA|||SPRID 0-4|
1598985|NCT02863575|2937888|Superiority||LS mean difference|24.04|||<|0.001|2-Sided|95.0|20.76|27.32|||ANCOVA|||SPRID 0-4|
1598986|NCT02863575|2937888|Superiority||LS mean difference|1.58|||<|0.177|2-Sided|95.0|-0.72|3.87|||ANCOVA|||SPRID 0-4|
1598987|NCT02863575|2937888|Superiority||LS mean difference|10.05|||<|0.001|2-Sided|95.0|8.45|11.64|||ANCOVA|||SPRID 0-2|
1598988|NCT02863575|2937888|Superiority||LS means difference|11.13|||<|0.001|2-Sided|95.0|9.54|12.73|||ANCOVA|||SPRID 0-2|
1598989|NCT02863575|2937888|Superiority||LS mean difference|1.09|||<|0.056|2-Sided|95.0|-0.03|2.2|||ANCOVA|||SPRID 0-2|
1598990|NCT02863575|2937889|Superiority||Least square (LS) means difference|2.68||||0.306|2-Sided|95.0|-2.46|7.82|||ANCOVA||||
1598991|NCT02863419|2937906|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.15|||<|0.0001|2-Sided|95.0|0.09|0.26||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1598992|NCT02863419|2937906|Superiority|This hypothesis was not controlled for multiplicity|Hazard Ratio (HR)|1.17|||<|0.6252|2-Sided|95.0|0.62|2.22||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 1.8 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1599033|NCT02858713|2938082|Superiority||coefficient|0.4||||0.047|2-Sided|95.0|0.005|0.795|||Regression, Linear|||LS-PGA: Change from baseline to week 4|
1623036|NCT02289729|2979648|Superiority|||||||0.0328|||||||t-test||||
1598993|NCT02863419|2937907|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.32|||<|0.0001|2-Sided|95.0|0.21|0.48||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Placebo|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1598994|NCT02863419|2937907|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.17|||<|0.4915|2-Sided|95.0|0.75|1.8||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Liraglutide 1.8 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1598995|NCT02863419|2937928|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-4.0|||<|0.0001|2-Sided|95.0|-4.8|-3.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral sema 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1598996|NCT02863419|2937928|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.5|||<|0.0001|2-Sided|95.0|-2.2|-0.9||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1598997|NCT02863419|2937928|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-3.8|||<|0.0001|2-Sided|95.0|-4.7|-3.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1598998|NCT02863419|2937928|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.2|||<|0.0003|2-Sided|95.0|-1.9|-0.6||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1598999|NCT02863419|2937929|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.2||||0.0001|2-Sided|95.0|-1.4|-1.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1599000|NCT02863419|2937929|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.2||||0.0056|2-Sided|95.0|-0.3|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1599034|NCT02858713|2938083|Superiority||Coefficient|-0.77||||0.348|2-Sided|95.0|-2.389|0.848|||Regression, Linear|||DLQI: Change from baseline to week 26|
1599035|NCT02858713|2938083|Superiority||Coefficient|-0.581||||0.45|2-Sided|95.0|-2.099|0.938|||Regression, Linear|||DLQI: Change from baseline to week 8|
1599036|NCT02858713|2938083|Superiority||Coefficient|-0.415||||0.545|2-Sided|95.0|-1.77|0.939|||Regression, Linear|||DLQI: Change from baseline to week 4|
1599001|NCT02863419|2937929|Non-Inferiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.2|||<|0.0001|2-Sided|95.0|-0.3|-0.1||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|MMRM||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1599002|NCT02863419|2937929|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.1|||<|0.0001|2-Sided|95.0|-1.2|-0.9||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1599003|NCT02863419|2937929|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.1|||<|0.0645|2-Sided|95.0|-0.3|0.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1599004|NCT02863419|2937929|Non-Inferiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.1|||<|0.0001|2-Sided|95.0|-0.3|0.0||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin. The non-inferiority margin was 0.4%|Pattern mixture model||Oral semaglutide 14 mg - Liraglutide 1.8 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1599005|NCT02863328|2937949|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.75||||0.225|2-Sided|95.0|0.47|1.19||Unadjusted two-sided p-value for test of no difference from 1.|Cox proportional hazards model||Oral semaglutide 14 mg / Empagliflozin 25 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1599006|NCT02863328|2937950|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.85||||0.3552|2-Sided|95.0|0.6|1.2||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Empagliflozin 25 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1599007|NCT02863328|2937978|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.4|||=|0|2-Sided|95.0|-1.0|0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1599008|NCT02863328|2937978|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.1|||=|0|2-Sided|95.0|-0.7|0.5||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1599037|NCT02858713|2938083|Superiority||Coefficient|-0.415|||=|0|2-Sided|95.0|-1.77|0.939|||Regression, Linear|||DLQI: Change baseline to week 4|
1599038|NCT02858713|2938084|Superiority||Odds Ratio (OR)|2.99|||=|0|2-Sided|95.0|1.42|6.28|||Regression, Logistic||||
1599039|NCT02858401|2938152|Other|||||||1|||||||Fisher Exact||||
1599009|NCT02863328|2937979|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.5|||<|0.0001|2-Sided|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1599010|NCT02863328|2937979|Non-Inferiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-0.5|||<|0.0001|2-Sided|95.0|-0.7|-0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|MMRM||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1599011|NCT02863328|2937979|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.4|||<|0.0001|2-Sided|95.0|-0.6|-0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1599012|NCT02863328|2937979|Non-Inferiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.4% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Treatment difference|-0.4|||<|0.0001|2-Sided|95.0|-0.6|-0.3||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.4%.|Pattern mixture model||Oral semaglutide 14 mg - Empagliflozin 25 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1599013|NCT02863198|2937990|Superiority or Other||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|Chi-squared||||
1599014|NCT02863198|2937991|Superiority or Other||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided||||
1599015|NCT02863198|2937992|Superiority or Other||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided||||
1599016|NCT02863198|2937993|Superiority or Other||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|Chi-squared||||
1599017|NCT02863198|2937994|Superiority or Other||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided||||
1599018|NCT02863198|2937995|Superiority or Other||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided||||
1599019|NCT02861664|2938045|Other||Least square (LS) mean difference|-0.6|||<|0.0001||95.0|-0.8|-0.4||From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|ANCOVA||Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.||
1599020|NCT02861118|2938055|Other|||||||0.003|||||||Regression, Logistic|||Skin Disease|
1599021|NCT02861118|2938055|Other|||||||0.002|||||||Regression, Logistic|||Corticosteroids|
1599022|NCT02861118|2938056|Other|||||||0.007|||||||Regression, Logistic|||Corticosteroids|
1599023|NCT02861118|2938057|Other|||||||0.003|||||||Regression, Logistic|||Myocardial Infarction|
1599024|NCT02861118|2938057|Other|||||||0.003|||||||Regression, Logistic|||Corticosteroids|
1599025|NCT02861118|2938057|Other|||||||0.044|||||||Regression, Logistic|||IBD|
1599026|NCT02861118|2938058|Other|||||||0.006|||||||Regression, Logistic|||Chronic Obstructive Pulmonary Disease|
1599027|NCT02861118|2938058|Other|||||||0.006|||||||Regression, Logistic|||Corticosteroids|
1599028|NCT02861118|2938058|Other|||||||0.024|||||||Regression, Logistic|||IBD|
1599029|NCT02859246|2938080|Superiority||||||<|0.2||||||A two tail P value of less than 0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)||||
1599030|NCT02859246|2938081|Superiority||||||<|0.04||||||A two tail P value of less than 0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)||||
1599031|NCT02858713|2938082|Superiority||Coefficient|0.18||||0.424|2-Sided|95.0|-0.264|0.625|||Regression, Linear|||LS-PGA: Change from baseline to week 26|
1599032|NCT02858713|2938082|Superiority||Coefficient|0.091||||0.662|2-Sided|95.0|-0.321|0.504|||Regression, Linear|||LS-PGA: Change from baseline to week 8|
1599040|NCT02858401|2938152|Other|||||||1|||||||Fisher Exact||||
1599068|NCT02858401|2938162|Other|||||||0.1757|||||||Wilcoxon rank sum test||||
1599069|NCT02858401|2938162|Other|||||||0.1757|||||||Wilcoxon rank sum test||||
1599070|NCT02858401|2938163|Other|||||||0.4652|||||||Wilcoxon rank sum test||||
1599071|NCT02858401|2938163|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599072|NCT02858401|2938163|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599073|NCT02858401|2938164|Other|||||||0.4652|||||||Wilcoxon rank sum test||||
1599074|NCT02858401|2938164|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599075|NCT02858401|2938164|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599076|NCT02858401|2938165|Other|||||||0.223|||||||Wilcoxon rank sum test||||
1599077|NCT02858401|2938165|Other|||||||0.1757|||||||Wilcoxon rank sum test||||
1599078|NCT02858401|2938165|Other|||||||0.1757|||||||Wilcoxon rank sum test||||
1599079|NCT02858401|2938166|Other|||||||1|||||||Wilcoxon rank sum test||||
1599080|NCT02858401|2938166|Other|||||||1|||||||Wilcoxon rank sum test||||
1599081|NCT02858401|2938166|Other|||||||1|||||||Wilcoxon rank sum test||||
1599082|NCT02858401|2938167|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599083|NCT02858401|2938167|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599084|NCT02858401|2938167|Other|||||||1|||||||Wilcoxon rank sum test||||
1599085|NCT02858401|2938168|Other|||||||0.3074|||||||Wilcoxon rank sum test||||
1599086|NCT02858401|2938168|Other|||||||0.3074|||||||Wilcoxon rank sum test||||
1599087|NCT02858401|2938169|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599088|NCT02858401|2938169|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599089|NCT02858401|2938169|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599090|NCT02858401|2938170|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599091|NCT02858401|2938170|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599092|NCT02858401|2938170|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599093|NCT02858401|2938171|Other|||||||0.5186|||||||Wilcoxon rank sum test||||
1599094|NCT02858401|2938171|Other|||||||0.5186|||||||Wilcoxon rank sum test||||
1599095|NCT02858401|2938171|Other|||||||0.6908|||||||Wilcoxon rank sum test||||
1599096|NCT02858401|2938171|Other|||||||0.5716|||||||Wilcoxon rank sum test||||
1599097|NCT02858401|2938171|Other|||||||0.8504|||||||Wilcoxon rank sum test||||
1599098|NCT02858401|2938172|Other|||||||0.5993|||||||Wilcoxon rank sum test||||
1599099|NCT02858401|2938172|Other|||||||0.1757|||||||Wilcoxon rank sum test||||
1599100|NCT02858401|2938172|Other|||||||0.1757|||||||Wilcoxon rank sum test||||
1599101|NCT02858401|2938173|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599102|NCT02858401|2938173|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599103|NCT02858401|2938173|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599104|NCT02858401|2938174|Other|||||||0.3074|||||||Wilcoxon rank sum test||||
1599105|NCT02858401|2938174|Other|||||||0.3074|||||||Wilcoxon rank sum test||||
1599106|NCT02858401|2938175|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599107|NCT02858401|2938175|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599108|NCT02858401|2938175|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599109|NCT02858401|2938176|Other|||||||1|||||||Wilcoxon rank sum test||||
1599110|NCT02858401|2938176|Other|||||||1|||||||Wilcoxon rank sum test||||
1599111|NCT02858401|2938176|Other|||||||1|||||||Wilcoxon rank sum test||||
1599112|NCT02858401|2938177|Other|||||||0.5383|||||||Wilcoxon rank sum test||||
1599113|NCT02858401|2938177|Other|||||||0.5383|||||||Wilcoxon rank sum test||||
1599114|NCT02858401|2938177|Other|||||||0.5383|||||||Wilcoxon rank sum test||||
1599115|NCT02858401|2938177|Other|||||||0.1784|||||||Wilcoxon rank sum test||||
1599116|NCT02858401|2938177|Other|||||||0.5896|||||||Wilcoxon rank sum test||||
1599117|NCT02858401|2938177|Other|||||||0.5383|||||||Wilcoxon rank sum test||||
1599118|NCT02858401|2938178|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599119|NCT02858401|2938178|Other|||||||1|||||||Wilcoxon rank sum test||||
1599120|NCT02858401|2938178|Other|||||||1|||||||Wilcoxon rank sum test||||
1599121|NCT02858401|2938179|Other|||||||0.5186|||||||Wilcoxon rank sum test||||
1599122|NCT02858401|2938179|Other|||||||0.5186|||||||Wilcoxon rank sum test||||
1599123|NCT02858401|2938179|Other|||||||0.6908|||||||Wilcoxon rank sum test||||
1599124|NCT02858401|2938179|Other|||||||0.5716|||||||Wilcoxon rank sum test||||
1599125|NCT02858401|2938179|Other|||||||0.5186|||||||Wilcoxon rank sum test||||
1599126|NCT02858401|2938180|Other|||||||0.1949|||||||Wilcoxon rank sum test||||
1599127|NCT02858401|2938180|Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1599128|NCT02858401|2938180|Other|||||||1|||||||Wilcoxon rank sum test||||
1599129|NCT02858401|2938180|Other|||||||1|||||||Wilcoxon rank sum test||||
1599130|NCT02858401|2938180|Other|||||||1|||||||Wilcoxon rank sum test||||
1599131|NCT02858401|2938180|Other|||||||1|||||||Wilcoxon rank sum test||||
1599132|NCT02858401|2938181|Other|||||||1|||||||Wilcoxon rank sum test||||
1599133|NCT02858401|2938181|Other|||||||1|||||||Wilcoxon rank sum test||||
1599134|NCT02858401|2938181|Other|||||||1|||||||Wilcoxon rank sum test||||
1599135|NCT02858401|2938182|Other|||||||0.7878|||||||Wilcoxon rank sum test||||
1599136|NCT02858401|2938182|Other|||||||0.5383|||||||Wilcoxon rank sum test||||
1599137|NCT02858401|2938182|Other|||||||0.5383|||||||Wilcoxon rank sum test||||
1599138|NCT02858401|2938182|Other|||||||0.8207|||||||Wilcoxon rank sum test||||
1599139|NCT02858401|2938182|Other|||||||0.6937|||||||Wilcoxon rank sum test||||
1599140|NCT02858401|2938182|Other|||||||0.5546|||||||Wilcoxon rank sum test||||
1599141|NCT02858401|2938183|Other|||||||0.7526|||||||Wilcoxon rank sum test||||
1599142|NCT02858401|2938183|Other|||||||0.4652|||||||Wilcoxon rank sum test||||
1599143|NCT02858401|2938183|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599144|NCT02858401|2938184|Other|||||||0.3237|||||||Wilcoxon rank sum test||||
1599145|NCT02858401|2938184|Other|||||||0.3237|||||||Wilcoxon rank sum test||||
1599146|NCT02858401|2938184|Other|||||||0.3237|||||||Wilcoxon rank sum test||||
1599147|NCT02858401|2938184|Other|||||||0.4577|||||||Wilcoxon rank sum test||||
1599148|NCT02858401|2938184|Other|||||||0.3755|||||||Wilcoxon rank sum test||||
1599149|NCT02858401|2938184|Other|||||||0.3237|||||||Wilcoxon rank sum test||||
1599150|NCT02858401|2938185|Other|||||||1|||||||Wilcoxon rank sum test||||
1599151|NCT02858401|2938185|Other|||||||1|||||||Wilcoxon rank sum test||||
1599152|NCT02858401|2938185|Other|||||||1|||||||Wilcoxon rank sum test||||
1599153|NCT02858401|2938186|Other|||||||0.5383|||||||Wilcoxon rank sum test||||
1599154|NCT02858401|2938186|Other|||||||0.5383|||||||Wilcoxon rank sum test||||
1599155|NCT02858401|2938186|Other|||||||0.5383|||||||Wilcoxon rank sum test||||
1599156|NCT02858401|2938186|Other|||||||0.8207|||||||Wilcoxon rank sum test||||
1599157|NCT02858401|2938186|Other|||||||0.5896|||||||Wilcoxon rank sum test||||
1599158|NCT02858401|2938186|Other|||||||0.5383|||||||Wilcoxon rank sum test||||
1599159|NCT02858401|2938187|Other|||||||1|||||||Wilcoxon rank sum test||||
1599160|NCT02858401|2938187|Other|||||||1|||||||Wilcoxon rank sum test||||
1599161|NCT02858401|2938187|Other|||||||1|||||||Wilcoxon rank sum test||||
1599162|NCT02858401|2938188|Other|||||||1|||||||Wilcoxon rank sum test||||
1599163|NCT02858401|2938188|Other|||||||1|||||||Wilcoxon rank sum test||||
1599164|NCT02858401|2938188|Other|||||||1|||||||Wilcoxon rank sum test||||
1599165|NCT02858401|2938188|Other|||||||0.1949|||||||Wilcoxon rank sum test||||
1599166|NCT02858401|2938188|Other|||||||1|||||||Wilcoxon rank sum test||||
1599167|NCT02858401|2938188|Other|||||||1|||||||Wilcoxon rank sum test||||
1599168|NCT02858401|2938189|Other|||||||1|||||||Wilcoxon rank sum test||||
1599169|NCT02858401|2938189|Other|||||||1|||||||Wilcoxon rank sum test||||
1599170|NCT02858401|2938189|Other|||||||1|||||||Wilcoxon rank sum test||||
1599171|NCT02858401|2938190|Other|||||||1|||||||Wilcoxon rank sum test||||
1599172|NCT02858401|2938190|Other|||||||1|||||||Wilcoxon rank sum test||||
1599173|NCT02858401|2938190|Other|||||||0.2763|||||||Wilcoxon rank sum test||||
1599174|NCT02858401|2938190|Other|||||||1|||||||Wilcoxon rank sum test||||
1599175|NCT02858401|2938190|Other|||||||1|||||||Wilcoxon rank sum test||||
1599176|NCT02858401|2938191|Other|||||||1|||||||Wilcoxon rank sum test||||
1599177|NCT02858401|2938191|Other|||||||1|||||||Wilcoxon rank sum test||||
1599178|NCT02858401|2938191|Other|||||||1|||||||Wilcoxon rank sum test||||
1599179|NCT02858401|2938191|Other|||||||0.1949|||||||Wilcoxon rank sum test||||
1599180|NCT02858401|2938191|Other|||||||1|||||||Wilcoxon rank sum test||||
1599181|NCT02858401|2938191|Other|||||||1|||||||Wilcoxon rank sum test||||
1599182|NCT02858401|2938192|Other|||||||0.5993|||||||Wilcoxon rank sum test||||
1599183|NCT02858401|2938192|Other|||||||0.4652|||||||Wilcoxon rank sum test||||
1599184|NCT02858401|2938192|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599185|NCT02858401|2938193|Other|||||||0.3456|||||||Wilcoxon rank sum test||||
1599186|NCT02858401|2938193|Other|||||||0.3456|||||||Wilcoxon rank sum test||||
1599187|NCT02858401|2938193|Other|||||||0.3456|||||||Wilcoxon rank sum test||||
1599188|NCT02858401|2938193|Other|||||||0.1301|||||||Wilcoxon rank sum test||||
1599189|NCT02858401|2938193|Other|||||||0.3971|||||||Wilcoxon rank sum test||||
1599190|NCT02858401|2938193|Other|||||||0.3456|||||||Wilcoxon rank sum test||||
1599191|NCT02858401|2938194|Other|||||||0.223|||||||Wilcoxon rank sum test||||
1599192|NCT02858401|2938194|Other|||||||0.4237|||||||Wilcoxon rank sum test||||
1599193|NCT02858401|2938194|Other|||||||0.3613|||||||Wilcoxon rank sum test||||
1599194|NCT02858401|2938195|Other|||||||0.5186|||||||Wilcoxon rank sum test||||
1599195|NCT02858401|2938195|Other|||||||0.5186|||||||Wilcoxon rank sum test||||
1599196|NCT02858401|2938195|Other|||||||0.1869|||||||Wilcoxon rank sum test||||
1599197|NCT02858401|2938195|Other|||||||0.5716|||||||Wilcoxon rank sum test||||
1599198|NCT02858401|2938195|Other|||||||0.5186|||||||Wilcoxon rank sum test||||
1599199|NCT02858401|2938196|Other|||||||1|||||||Wilcoxon rank sum test||||
1599200|NCT02858401|2938196|Other|||||||1|||||||Wilcoxon rank sum test||||
1599201|NCT02858401|2938196|Other|||||||1|||||||Wilcoxon rank sum test||||
1599202|NCT02858401|2938196|Other|||||||0.4278|||||||Wilcoxon rank sum test||||
1599203|NCT02858401|2938196|Other|||||||1|||||||Wilcoxon rank sum test||||
1599204|NCT02858401|2938196|Other|||||||0.1949|||||||Wilcoxon rank sum test||||
1599205|NCT02858401|2938197|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599206|NCT02858401|2938197|Other|||||||1|||||||Wilcoxon rank sum test||||
1599207|NCT02858401|2938197|Other|||||||1|||||||Wilcoxon rank sum test||||
1599208|NCT02858401|2938198|Other|||||||1|||||||Wilcoxon rank sum test||||
1599209|NCT02858401|2938198|Other|||||||1|||||||Wilcoxon rank sum test||||
1599210|NCT02858401|2938198|Other|||||||1|||||||Wilcoxon rank sum test||||
1599211|NCT02858401|2938198|Other|||||||0.1556|||||||Wilcoxon rank sum test||||
1599212|NCT02858401|2938198|Other|||||||1|||||||Wilcoxon rank sum test||||
1599213|NCT02858401|2938198|Other|||||||1|||||||Wilcoxon rank sum test||||
1599214|NCT02858401|2938199|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599215|NCT02858401|2938199|Other|||||||1|||||||Wilcoxon rank sum test||||
1599216|NCT02858401|2938199|Other|||||||1|||||||Wilcoxon rank sum test||||
1599217|NCT02858401|2938200|Other|||||||1|||||||Wilcoxon rank sum test||||
1599218|NCT02858401|2938200|Other|||||||1|||||||Wilcoxon rank sum test||||
1599219|NCT02858401|2938200|Other|||||||1|||||||Wilcoxon rank sum test||||
1599220|NCT02858401|2938201|Other|||||||1|||||||Wilcoxon rank sum test||||
1599221|NCT02858401|2938201|Other|||||||1|||||||Wilcoxon rank sum test||||
1599222|NCT02858401|2938201|Other|||||||1|||||||Wilcoxon rank sum test||||
1599223|NCT02858401|2938201|Other|||||||0.1949|||||||Wilcoxon rank sum test||||
1599224|NCT02858401|2938201|Other|||||||1|||||||Wilcoxon rank sum test||||
1599225|NCT02858401|2938201|Other|||||||1|||||||Wilcoxon rank sum test||||
1599226|NCT02858401|2938202|Other|||||||0.3613|||||||Wilcoxon rank sum test||||
1599227|NCT02858401|2938202|Other|||||||1|||||||Wilcoxon rank sum test||||
1599228|NCT02858401|2938202|Other|||||||1|||||||Wilcoxon rank sum test||||
1599229|NCT02858401|2938203|Other|||||||1|||||||Wilcoxon rank sum test||||
1599230|NCT02858401|2938203|Other|||||||1|||||||Wilcoxon rank sum test||||
1599231|NCT02858401|2938203|Other|||||||1|||||||Wilcoxon rank sum test||||
1599232|NCT02858401|2938203|Other|||||||0.1556|||||||Wilcoxon rank sum test||||
1599233|NCT02858401|2938203|Other|||||||1|||||||Wilcoxon rank sum test||||
1599234|NCT02858401|2938203|Other|||||||1|||||||Wilcoxon rank sum test||||
1599235|NCT02858401|2938204|Other|||||||0.4047|||||||Wilcoxon rank sum test||||
1599236|NCT02858401|2938204|Other|||||||1|||||||Wilcoxon rank sum test||||
1599237|NCT02858401|2938204|Other|||||||1|||||||Wilcoxon rank sum test||||
1599238|NCT02858401|2938205|Other|||||||0.5557|||||||Wilcoxon rank sum test||||
1599239|NCT02858401|2938205|Other|||||||0.6056|||||||Wilcoxon rank sum test||||
1599240|NCT02858401|2938205|Other|||||||0.5557|||||||Wilcoxon rank sum test||||
1599241|NCT02858401|2938205|Other|||||||0.8288|||||||Wilcoxon rank sum test||||
1599242|NCT02858401|2938205|Other|||||||0.5557|||||||Wilcoxon rank sum test||||
1599243|NCT02858401|2938205|Other|||||||0.5557|||||||Wilcoxon rank sum test||||
1599244|NCT02858401|2938206|Other|||||||1|||||||Wilcoxon rank sum test||||
1599245|NCT02858401|2938206|Other|||||||1|||||||Wilcoxon rank sum test||||
1599246|NCT02858401|2938206|Other|||||||1|||||||Wilcoxon rank sum test||||
1599247|NCT02858401|2938207|Other|||||||0.5895|||||||Wilcoxon rank sum test||||
1599248|NCT02858401|2938207|Other|||||||0.0289|||||||Wilcoxon rank sum test||||
1599249|NCT02858401|2938207|Other|||||||0.1228|||||||Wilcoxon rank sum test||||
1599250|NCT02858401|2938207|Other|||||||0.2807|||||||Wilcoxon rank sum test||||
1599251|NCT02858401|2938207|Other|||||||0.064|||||||Wilcoxon rank sum test||||
1599252|NCT02858401|2938207|Other|||||||0.1498|||||||Wilcoxon rank sum test||||
1599253|NCT02858362|2938225|Other|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|2.21|||||2-Sided|95.0|0.096|4.324||||||Week 48 Change from Baseline|
1599254|NCT02858362|2938225|Other|Difference in least square means. All 24 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|-1.837|||||2-Sided|95.0|-3.989|0.315||||||Week 24 Change from Baseline|
1599255|NCT02858362|2938226|Other|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|1.166|||||2-Sided|95.0|-1.103|3.435||||||Week 48 Change from Baseline|
1599256|NCT02858362|2938226|Other|Difference in least square means. All 24 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|-2.611|||||2-Sided|95.0|-4.324|-0.898||||||Week 24 Change from Baseline|
1599257|NCT02858362|2938227|Other|Difference in least square means. All 16 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|0.006|||||2-Sided|95.0|-0.03|0.042||||||Week 48 Change from Baseline|
1599258|NCT02858362|2938227|Other|Difference in least square means. All 23 participants in the population were included in the statistical analysis.|Mean Difference (Final Values)|0.023|||||2-Sided|95.0|-0.002|0.048||||||Week 24 Change from Baseline|
1599259|NCT02858349|2938245|Superiority||Mean Difference (Net)|0.13||||0.0042|2-Sided|95.0|0.05|0.21|||Mixed Models Analysis||||
1599260|NCT02858180|2938248|Other||Proportion|86.7|||||2-Sided|95.0|59.5|98.3|||||||
1599261|NCT02858050|2938250|Other|||||||0.548306|||||||Chi-squared||||
1599262|NCT02857816|2938253|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||This is a single arm study. The primary objective was to demonstrate a statistically significant reduction between baseline and following the 12th PTNM therapy sessions in the number of UUI episodes per day.|
1599263|NCT02857283|2938255|Superiority|||||||0.9515|||||||Wilcoxon (Mann-Whitney)|paired|||
1599264|NCT02857283|2938257|Superiority|||||||0.698|||||||Wilcoxon (Mann-Whitney)|paired|||
1599265|NCT02857283|2938258|Superiority|||||||0.6698|||||||Wilcoxon (Mann-Whitney)|paired|||
1599266|NCT02857283|2938259|Superiority|||||||0.583|||||||Wilcoxon (Mann-Whitney)|paired|||
1599267|NCT02857283|2938260|Superiority|||||||0.0785|||||||Wilcoxon (Mann-Whitney)|paired|||
1599268|NCT02857283|2938261|Superiority|||||||0.1543|||||||Wilcoxon (Mann-Whitney)|paired|||
1599269|NCT02857283|2938262|Superiority|||||||0.0547|||||||Wilcoxon (Mann-Whitney)|Paired|||
1599270|NCT02857283|2938262|Superiority|||||||0.4967|||||||Wilcoxon (Mann-Whitney)|unpaired|||
1599271|NCT02857283|2938263|Superiority|||||||0.5416|||||||Wilcoxon (Mann-Whitney)|paired|||
1599272|NCT02857283|2938264|Superiority|||||||0.9307|||||||Wilcoxon (Mann-Whitney)|unpaired|||
1599273|NCT02857283|2938265|Superiority|||||||0.7619|||||||Wilcoxon (Mann-Whitney)|unpaired|||
1599274|NCT02856880|2938266|Superiority or Other||LS mean difference|-89.54||||0.8935|2-Sided|95.0|-1439.5|1260.41||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.||
1599275|NCT02856880|2938266|Superiority or Other||LS mean difference|-1037.52||||0.121|2-Sided|95.0|-2361.33|286.29||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant -level pre-treatment values and period minus participant -level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.||
1599276|NCT02856880|2938266|Superiority or Other||LS mean difference|-270.88||||0.6998|2-Sided|95.0|-1680.58|1138.82||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.||
1599277|NCT02856880|2938266|Superiority or Other||LS mean difference|947.97||||0.1511|2-Sided|95.0|-361.95|2257.9||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.||
1599278|NCT02856880|2938266|Superiority or Other||LS mean difference|-763.6||||0.2702|2-Sided|95.0|-2144.45|617.25||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.||
1599279|NCT02856880|2938266|Superiority or Other||LS mean difference|766.64||||0.2976|2-Sided|95.0|-703.26|2236.54||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.||
1599280|NCT02856880|2938266|Superiority or Other||LS mean difference|3.04||||0.9967|2-Sided|95.0|-1469.45|1475.52||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.||
1599281|NCT02856880|2938266|Superiority or Other||LS mean difference|677.09||||0.3544|2-Sided|95.0|-784.16|2138.35||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.||
1599282|NCT02856880|2938266|Superiority or Other||LS mean difference|674.06||||0.3249|2-Sided|95.0|-692.21|2040.33||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.||
1599283|NCT02856880|2938266|Superiority or Other||LS mean difference|-273.92||||0.6664|2-Sided|95.0|-1550.45|1002.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a smaller live:dead stain ratio for the first named treatment.||
1599284|NCT02856880|2938267|Superiority or Other||LS mean difference|-25.78||||0.6086|2-Sided|95.0|-126.53|74.96||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.||
1599285|NCT02856880|2938267|Superiority or Other||LS mean difference|-294.53|||<|0.0001|2-Sided|95.0|-395.43|-193.62||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.||
1599286|NCT02856880|2938267|Superiority or Other||LS mean difference|-293.47|||<|0.0001|2-Sided|95.0|-396.03|-190.91||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.||
1599287|NCT02856880|2938267|Superiority or Other||LS mean difference|268.74|||<|0.0001|2-Sided|95.0|165.98|371.51||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is second named treatment(non-SLS negative control) minus first named treatment (SLS negative control) such that a negative difference indicates a greater inhibition of plaque||
1599288|NCT02856880|2938267|Superiority or Other||LS mean difference|-61.31|||<|0.2226|2-Sided|95.0|-161.14|38.52||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.||
1599482|NCT02842853|2939034|Other||Percentage Difference|0.5|||||2-Sided|95.0|-2.14|3.07||||||Serogroup Y: Lot 1 vs Lot 2|
1599289|NCT02856880|2938267|Superiority or Other||LS mean difference|1.05|||<|0.9834|2-Sided|95.0|-100.5|102.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.||
1599290|NCT02856880|2938267|Superiority or Other||LS mean difference|-60.26|||<|0.2427|2-Sided|95.0|-162.72|42.21||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.||
1599291|NCT02856880|2938267|Superiority or Other||LS mean difference|-24.73|||<|0.6325|2-Sided|95.0|-128.07|78.61||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.||
1599292|NCT02856880|2938267|Superiority or Other||LS mean difference|35.53|||<|0.5018|2-Sided|95.0|-69.9|140.96||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.||
1599293|NCT02856880|2938267|Superiority or Other||LS mean difference|-233.22|||<|0.0001|2-Sided|95.0|-332.88|-133.55||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference indicates a greater inhibition of plaque regrowth for the first named treatment.||
1599294|NCT02856880|2938268|Superiority or Other||LS mean difference|2.42||||0.5174|2-Sided|95.0|-5.08|9.92||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.||
1599295|NCT02856880|2938268|Superiority or Other||LS mean difference|31.74|||<|0.0001|2-Sided|95.0|24.18|39.3||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.||
1599296|NCT02856880|2938268|Superiority or Other||LS mean difference|-29.32|||<|0.0001|2-Sided|95.0|-37.2|-21.43||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.||
1599297|NCT02856880|2938268|Superiority or Other||LS mean difference|5.32|||<|0.1573|2-Sided|95.0|-2.15|12.79||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.||
1599298|NCT02856880|2938268|Superiority or Other||LS mean difference|8.44|||<|0.0286|2-Sided|95.0|0.93|15.95||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.||
1599299|NCT02856880|2938268|Superiority or Other||LS mean difference|13.77|||<|0.0009|2-Sided|95.0|6.01|21.53||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.||
1599300|NCT02856880|2938268|Superiority or Other||LS mean difference|10.86|||<|0.0072|2-Sided|95.0|3.13|18.59||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.||
1599301|NCT02856880|2938268|Superiority or Other||LS mean difference|-2.91|||<|0.4823|2-Sided|95.0|-11.18|5.37||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of glycolysis for the first named treatment.||
1599302|NCT02856880|2938268|Superiority or Other||LS mean difference|26.41|||<|0.0001|2-Sided|95.0|18.94|33.88||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque glycolysis for the first named treatment.||
1599483|NCT02842853|2939034|Other||Percentage Difference|3.7|||||2-Sided|95.0|0.708|6.79||||||Serogroup C: Lot 1 vs Lot 3|
1599303|NCT02856880|2938269|Superiority or Other||Least square (LS) mean difference|40.18|||<|0.0001|2-Sided|95.0|32.37|47.99||Obtained from ANCOVA including period and treatment as fixed effects, participant as a random effect and participant-level pre-treatment values and period minus participant-level pre-treatment values as covariates in the model.|ANCOVA||Difference is first named treatment minus second named treatment such that a positive difference indicates a greater inhibition of plaque Glycolysis for the first named treatment.||
1599304|NCT02854631|2938332|Superiority|||||||0.3|||||||Fisher Exact|Fisher's exact test (2-sided) was used to explore differences between groups in the percentage of participants with response/non-response.|||
1599305|NCT02854631|2938348|Superiority|||||||0.22||||||P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.|Fisher Exact||||
1599306|NCT02854631|2938349|Superiority|||||||0.06|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.|||
1599307|NCT02854631|2938350|Superiority|||||||0.061|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.|||
1599308|NCT02854631|2938351|Superiority|||||||1|||||||Fisher Exact|P-value from 2-sided Fisher's exact test was used to explore differences between treatment groups in the percentage of participants with an event.|||
1599309|NCT02854540|2938357|Other||Mean difference (percent)|59.0|Standard Deviation|16.0|||2-Sided||||||||||
1599310|NCT02854527|2938358|Superiority or Other||Adjusted Geometric mean ratio (T/R4) (%)|107.63|Standard Deviation|19.4|||2-Sided|90.0|97.04|119.39|||||Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R4.|
1599311|NCT02854527|2938359|Superiority or Other||Adjusted Geometric mean ratio (T/R3) (%)|97.5|Standard Deviation|8.9|||2-Sided|90.0|93.58|101.58|||||Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R3.|
1599312|NCT02854527|2938360|Superiority or Other||Adjusted Geometric mean ratio (T/R2) (%)|97.4|Standard Deviation|9.6|||2-Sided|90.0|90.87|104.41|||||Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R2.|
1599313|NCT02854527|2938361|Superiority or Other||Adjusted Geometric mean ratio (T/R1) (%)|96.53|Standard Deviation|10.1|||2-Sided|90.0|92.08|101.2|||||Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the secondary outcome measure of treatment R1.|
1599314|NCT02854527|2938362|Superiority or Other||Adjusted Geometric mean ratio (T/R4) (%)|104.28|Standard Deviation|20.6|||2-Sided|90.0|94.95|114.53|||||Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R4.|
1599315|NCT02854527|2938363|Superiority or Other||Adjusted Geometric mean ratio (T/R4) (%)|105.01|Standard Deviation|18.8|||2-Sided|90.0|96.39|114.4|||||Least square estimates of log-transformed PK endpoint for T and R4 were back transformed to original scale to get adjusted gMean ratio (T/R4) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R4.|
1599316|NCT02854527|2938364|Superiority or Other||Adjusted Geometric mean ratio (T/R3) (%)|98.25|Standard Deviation|14.7|||2-Sided|90.0|91.85|105.09|||||Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R3.|
1599317|NCT02854527|2938365|Superiority or Other||Adjusted Geometric mean ratio (T/R3) (%)|97.49|Standard Deviation|9.0|||2-Sided|90.0|93.54|101.61|||||Least square estimates of log-transformed PK endpoint for T and R3 were back transformed to original scale to get adjusted gMean ratio (T/R3) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R3.|
1599318|NCT02854527|2938366|Superiority or Other||Adjusted Geometric mean ratio (T/R2) (%)|103.96|Standard Deviation|24.0|||2-Sided|90.0|93.6|115.46|||||Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R2.|
1599319|NCT02854527|2938367|Superiority or Other||Adjusted Geometric mean ratio (T/R2) (%)|102.62|Standard Deviation|20.4|||2-Sided|90.0|93.82|112.25|||||Least square estimates of log-transformed PK endpoint for T and R2 were back transformed to original scale to get adjusted gMean ratio (T/R2) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R2.|
1599381|NCT02848664|2938822|Equivalence|Examination of whether the level of swallowing handicap is changed following device use|Mean Difference (Net)|22.571||||0.016|2-Sided|95.0|6.003|39.14|||t-test, 2 sided||||
1599320|NCT02854527|2938368|Superiority or Other||Adjusted Geometric mean ratio (T/R1) (%)|93.17|Standard Deviation|24.1|||2-Sided|90.0|83.49|103.97|||||Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the second primary outcome measure of treatment R1.|
1599321|NCT02854527|2938369|Superiority or Other||Adjusted Geometric mean ratio (T/R1) (%)|96.39|Standard Deviation|19.4|||2-Sided|90.0|88.22|105.33|||||Least square estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted gMean ratio (T/R1) and its 2-sided 90% CI. Standard deviation is intra-individual geometric coefficient of variation (%).|This statistical analysis assess the effect of the other cocktail compounds in treatment T on the first primary outcome measure of treatment R1.|
1599322|NCT02853435|2938502|Other||Median Difference (Final Values)|-0.492|||<|0.001|2-Sided|90.0|-0.5|-0.25||The p-value is from Wilcoxon signed-rank test.|Wilcoxon signed-rank test.||The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.||
1599323|NCT02853435|2938502|Other||Median Difference (Final Values)|-0.233|||<|0.309|2-Sided|90.0|-0.267|0.0||The p-value is from Wilcoxon signed-rank test.|Wilcoxon signed-rank test.||The median, median difference and 90% CI of the median difference are from Hodge-Lehmann estimate.||
1599324|NCT02853435|2938503|Other||Ratio of geometric LS means|1.1487|||||2-Sided|90.0|1.0113|1.3047|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.||
1599325|NCT02853435|2938503|Other||Ratio of geometric LS means|0.9586|||||2-Sided|90.0|0.844|1.0888|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters Cmax.||
1599326|NCT02853435|2938505|Other||Ratio of geometric LS means|1.1138|||||2-Sided|90.0|1.0479|1.1838|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).||
1599327|NCT02853435|2938505|Other||Ratio of geometric LS means|1.0408|||||2-Sided|90.0|0.9792|1.1062|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-t).||
1599328|NCT02853435|2938506|Other||Ratio of geometric LS means|1.1108|||||2-Sided|90.0|1.0459|1.1797|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).||
1599329|NCT02853435|2938506|Other||Ratio of geometric LS means|1.0417|||||2-Sided|90.0|0.9809|1.1063|||||A mixed effects model with treatment, sequence, period as fixed effects and participant within sequence as random effect was performed on the natural log-transformed parameters AUC(0-inf).||
1599330|NCT02853331|2938520|Superiority||Difference in percentages|11.0|||||2-Sided|95.0|4.8|17.0|||||Difference in percentages based on Miettinen & Nurminen method stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).||
1599331|NCT02853331|2938521|Superiority||Difference in percentages|23.6|||<|0.0001|2-Sided|95.0|17.2|29.9|||Miettinen & Nurminen method|H0: difference in %=0 versus H1: difference in % >0|Difference in percentages based on Miettinen & Nurminen method stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).||
1599332|NCT02853331|2938522|Superiority||Hazard Ratio (HR)|0.53||||5e-05|2-Sided|95.0|0.38|0.74|||Log Rank||HR based on Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).||
1599333|NCT02853331|2938523|Superiority||Hazard Ratio (HR)|0.69||||0.00012|2-Sided|95.0|0.56|0.84|||Log Rank||HR based on Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).||
1599334|NCT02853123|2938524|Superiority||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.099||0.3634|2-Sided|95.0|-0.106|0.286|||Mixed Effect Model Repeated Measures|Kenward−Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within−patient variation.|
1599335|NCT02853123|2938525|Superiority||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.12||0.8025|2-Sided|95.0|-0.268|0.208|||Mixed Effect Model Repeated Measures|Kenward−Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within−patient variation.|
1599336|NCT02853123|2938526|Superiority||Mean Difference (Final Values)|-0.318|Standard Error of the Mean|0.14||0.0258|2-Sided|95.0|-0.596|-0.039|||Mixed Effect Model Repeated Measures|Kenward−Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|2.5 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within−patient variation.|
1599367|NCT02849509|2938657|Other||||||<|0.0001||||||p-value of paired t-test compared to baseline|Paired t-test|||Convenience dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.|
1599477|NCT02842853|2939034|Other||Percentage Difference|2.8|||||2-Sided|95.0|-1.02|6.61||||||Serogroup W: Lot 1 vs Lot 3|
1599337|NCT02853123|2938526|Superiority||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.107||0.0267|2-Sided|95.0|-0.452|-0.028|||Mixed Effect Model Repeated Measures|Kenward−Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|2 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within−patient variation.|
1599338|NCT02853123|2938526|Superiority||Mean Difference (Final Values)|-0.108|Standard Error of the Mean|0.096||0.2645|2-Sided|95.0|-0.3|0.083|||Mixed Effect Model Repeated Measures|Kenward−Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|1 min, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within−patient variation.|
1599339|NCT02853123|2938527|Superiority||Mean Difference (Final Values)|0.201|Standard Error of the Mean|0.034|<|0.0001|2-Sided|95.0|0.134|0.267|||Mixed Effect Model Repeated Measures|Kenward−Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within−patient variation.|
1599340|NCT02853123|2938528|Superiority||Mean Difference (Final Values)|0.155|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.117|0.194|||Mixed Effect Model Repeated Measures|Kenward−Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within−patient variation.|
1599341|NCT02853123|2938529|Superiority||Mean Difference (Final Values)|0.066|Standard Error of the Mean|0.038||0.0852|2-Sided|95.0|-0.009|0.141|||Mixed Effect Model Repeated Measures|Kenward−Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|IC measured end of exercise, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within−patient variation.|
1599342|NCT02853123|2938530|Superiority||Mean Difference (Final Values)|0.185|Standard Error of the Mean|0.04|<|0.0001|2-Sided|95.0|0.106|0.265|||Mixed Effect Model Repeated Measures|Kenward−Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|IC measured prior to exercise, the adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within−patient variation.|
1599343|NCT02853123|2938531|Superiority||Mean Difference (Final Values)|-0.357|Standard Error of the Mean|0.153||0.0217|2-Sided|95.0|-0.661|-0.053|||Mixed Effect Model Repeated Measures|Kenward−Roger approximation of denominator was used for degrees of freedom.|Mean difference means the treatment difference vs. Tiotropium (i.e. Tiotropium/Olodaterol - Tiotropium).|The adjusted means (SE) are obtained from fitting an Mixed-effects Model Repeated Measures (MMRM) model including treatment and period as fixed effects, patient as a random effect, and period baseline and patient baseline as covariates, compound symmetry covariance structure for within−patient variation.|
1599344|NCT02850965|2938571|Other|Missing DLQI at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in DLQI Response Rate|0.4|||||2-Sided|95.0|-11.7|11.3|||||Difference in DLQI (0, 1) Response Rate = (BI 695501 – US-licensed Humira, %)|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.
1599345|NCT02850965|2938572|Other|Missing sPGA at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in sPGA <= 1 Response Rate|7.5|||||2-Sided|95.0|-4.8|19.1|||||Difference in sPGA <= 1 Response Rate = (BI 695501 – US-licensed Humira, %)|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.
1599346|NCT02850965|2938573|Other||Difference of Least Squares Means|1.7|||||2-Sided|95.0|-2.7|6.0|||||Difference of Least Squares Means (LSM)= LSM of (BI 695501 – Humira)|Analysis of covariance (ANCOVA) was performed based on the following model: PASI percentage improvement from baseline at Week 16= Treatment + Baseline PASI +Prior exposure to a biologic agent + random error.|
1599347|NCT02850965|2938574|Other|Missing PASI 75 at Week 24 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF).|Difference in PASI 75 Response Rate|2.9|||||2-Sided|95.0|-8.5|12.6|||||Difference in PASI 75 Response Rate = (BI 695501 – US-licensed Humira, %).|The week 24 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 24)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.
1599478|NCT02842853|2939034|Other||Percentage Difference|2.0|||||2-Sided|95.0|-1.84|5.89||||||Serogroup W: Lot 2 vs Lot 3|
1599348|NCT02850965|2938575|Equivalence|Protocol defined margins are: [-18.0%, +18.0%] for Week 16, 95% confidence interval. Between-imputation variance is zero. Confidence interval is based on one imputed set.|Difference in PASI 75 Response Rate|-2.2|||||2-Sided|95.0|-14.4|8.7|||||Difference in PASI 75 Response Rate = (BI 695501 – US-licensed Humira, %).|The week 16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve.|The statistical model: Logit (response to treatment at Week 16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.
1599349|NCT02849704|2938601|Superiority||||||>|0.05||||||a priori threshold for statistical significance <0.05|t-test, 2 sided||||
1599350|NCT02849704|2938602|Superiority||||||<|0.05||||||a priori threshold for statistical significance <0.05|t-test, 2 sided||||
1599351|NCT02849704|2938603|Superiority||||||>|0.05||||||a priori threshold for statistical significance <0.05|t-test, 2 sided||||
1599352|NCT02849704|2938604|Superiority||||||<|0.01||||||a priori threshold for statistical significance <0.05|t-test, 2 sided||||
1599353|NCT02849704|2938605|Superiority||||||>|0.05||||||a priori threshold for statistical significance <0.05|t-test, 2 sided||||
1599354|NCT02849704|2938606|Superiority||||||<|0.001||||||a priori threshold for significance: <0.05|t-test, 2 sided||||
1599355|NCT02849678|2938607|Non-Inferiority|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.063|||||||ANOVA|Local Anesthetic Consumption through para-vertebral catheters in PACU vs. at 24 hours vs. 48 hours|||
1599356|NCT02849678|2938608|Non-Inferiority|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.635||||||Hydromorphone consumption (mg) in PACU versus at 24 hours versus 48 hours|ANOVA||||
1599357|NCT02849678|2938608|Non-Inferiority|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.193||||||Hydromorphone consumption (mg) in Post-Anesthesia Care Unit (PACU)|t-test, 2 sided||||
1599358|NCT02849678|2938610|Non-Inferiority|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.636|||||||t-test, 1 sided||||
1599359|NCT02849678|2938612|Non-Inferiority|A total sample size of 64 subjects (32 patients in each arm) is required to detect a difference of 0.5 SD, using an alpha error of 0.05 and a power of 0.8. After enrollment of 47 patients, we decided to complete the present interim analysis, and the study was then interrupted due to equivalence in results between the two groups.||||||0.148|||||||t-test, 1 sided||||
1599360|NCT02849509|2938649|Other|||||||0.974||||||p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3)|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.|
1599361|NCT02849509|2938649|Other|||||||0.1234||||||p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3)|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort A, were compared between second assessment (Visit 2) and last assessment (Visit 3). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.|
1599362|NCT02849509|2938655|Other|||||||0.03||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.|
1599363|NCT02849509|2938655|Other|||||||0.0287||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.|
1599364|NCT02849509|2938656|Other|||||||0.2226||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Satisfaction dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.|
1599365|NCT02849509|2938656|Other|||||||0.0423||||||p-value of paired t-test compared between matched Pradaxa® and VKA patients|Paired t-test|||Convenience dimension score of PACT-Q2 for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.|
1599366|NCT02849509|2938657|Other|||||||0.0004||||||p-value of paired t-test compared to baseline|Paired t-test|||Satisfaction dimension score of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.|
1599479|NCT02842853|2939034|Other||Percentage Difference|0.8|||||2-Sided|95.0|-3.0|4.54||||||Serogroup W: Lot 1 vs Lot 2|
1599368|NCT02849509|2938658|Other|||||||0.0174||||||p-value of paired t-test compared to baseline|Paired t-test|||Satisfaction dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.|
1599369|NCT02849509|2938658|Other||||||<|0.0001||||||p-value of paired t-test compared to baseline|Paired t-test|||Convenience dimension score of PACT-Q2 at the second assessment (Visit 2) were compared with the baseline assessment (Visit 1). There was no (confirmatory) hypothesis testing foreseen in a strict statistical sense. Analyses were descriptive in nature and p-values from statistical models were used for exploratory purposes.|
1599370|NCT02849418|2938738|Other||Mean Difference (Net)|-3.02|||||2-Sided|95.0|-5.85|-0.19|||||The analysis method was mixed-model for repeated measures (MMRM) with treatment, visit, treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.||
1599371|NCT02849080|2938776|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.47||||0.079|2-Sided|95.0|0.2|1.09||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide flex- Switch / Sitagliptin 100 mg- Switch|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1599372|NCT02849080|2938777|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77||||0.4381|2-Sided|95.0|0.39|1.5||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide flex- Switch / Sitagliptin 100 mg- Switch|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.|
1599373|NCT02849080|2938796|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.58||||0.0175|2-Sided|95.0|0.37|0.91||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral Semaglutide flex / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before planned end of treatment.|
1599374|NCT02849080|2938797|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.18|||<|0.0001|2-Sided|95.0|0.09|0.39||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide flex / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1599375|NCT02849080|2938814|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-2.2|||<|0.0001|2-Sided|95.0|-2.9|-1.5||Unadjusted two-sided p-value for test of no difference from 0.|Mixed model for repeated measurements||Oral semaglutide flex - Sitagliptin 100 mg|The analysis was based on a Mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 52. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1599376|NCT02849080|2938814|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-1.9|||<|0.0001|2-Sided|95.0|-2.6|-1.2||Unadjusted two-sided p-value for test of no difference from 0.|Pattern mixture model||Oral semaglutide flex - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.|
1599377|NCT02849080|2938815|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Odds Ratio (OR)|5.54|||<|0.0001|2-Sided|95.0|3.54|8.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Logistic||Oral Semaglutide flex / Sitagliptin 100 mg|The analysis was based on multiple imputation, imputing sequentially using post-baseline measurements up to and including week 52. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.|
1599378|NCT02849080|2938815|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Odds Ratio (OR)|4.4|||<|0.0001|2-Sided|95.0|2.89|6.7||Unadjusted two-sided p-value for test of no difference from 1.|Pattern mixture model||Oral Semaglutide flex / Sitagliptin 100 mg.|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 52 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using a logistic regression model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete datasets, and pooled by Rubin's rule to draw inference.|
1599379|NCT02848664|2938820|Equivalence|pairwise comparison within subject comparing baseline with 3 months post device use|Mean Difference (Final Values)|-52.78||||0.037|2-Sided|95.0|-100.751|-4.809|||ANOVA||||
1599380|NCT02848664|2938821|Equivalence|whether the degree of laryngeal elevation relative to hyoid elevation became greater or less after device use for 3 months||||||0.046|||||||t-test, 2 sided||||
1599382|NCT02848664|2938823|Other|Same DOSS score before and after device use for 3 months or improved DOSS score after device use for 3 months|||||<|0.025||||||p values adjusted for multiple comparisons (two outcome measures)|Wilcoxon (Mann-Whitney)|||Examined change in DOSS for each participant from before to after three months of device use. Examined numbers of participants who showed either worsening of DOSS, no improvement in DOSS or improvement of DOSS.|
1599383|NCT02848651|2938824|Superiority||Differences in Rates|41.37|||<|0.0001|2-Sided|90.0|22.13|60.61|||Cochran-Mantel-Haenszel||||
1599384|NCT02848651|2938824|Superiority||Difference in Rates|30.22|||<|0.0001|2-Sided|90.0|14.82|45.62|||Cochran-Mantel-Haenszel||||
1599385|NCT02848651|2938824|Superiority||Differences in Rates|13.27|||<|0.0326|2-Sided|90.0|2.53|24.0|||Cochran-Mantel-Haenszel||||
1599386|NCT02848651|2938825|Superiority||Hazard Ratio (HR)|0.44||||0.0358|2-Sided|90.0|0.23|0.85|||Log Rank||||
1599387|NCT02848651|2938825|Superiority||Hazard Ratio (HR)|0.66||||0.1783|2-Sided|90.0|0.4|1.1|||Log Rank||||
1599388|NCT02848651|2938832|Superiority||Hazard Ratio (HR)|0.8||||0.3502|2-Sided|90.0|0.54|1.18|||Log Rank||||
1599389|NCT02848326|2938834|Superiority||Least squares mean difference|-1.22|Standard Error of the Mean|0.36||0.0007|2-Sided|95.0|-1.93|-0.52||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599390|NCT02848326|2938834|Superiority||Least squares mean difference|-1.35|Standard Error of the Mean|0.37||0.0003|2-Sided|95.0|-2.08|-0.62||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599391|NCT02848326|2938834|Superiority||Least squares mean difference|-1.11|Standard Error of the Mean|0.29||0.0001|2-Sided|95.0|-1.68|-0.54||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599392|NCT02848326|2938834|Superiority||Least squares mean difference|-1.44|Standard Error of the Mean|0.29|<|0.0001|2-Sided|95.0|-2.01|-0.87||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599393|NCT02848326|2938834|Superiority||Least squares mean difference|-1.3|Standard Error of the Mean|0.35|<|0.0002|2-Sided|95.0|-1.99|-0.6||MMRM model included baseline monthly acute medication use days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599394|NCT02848326|2938835|Superiority||Odds Ratio (OR)|2.03||||0.0019|2-Sided|95.0|1.3|3.18||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measure||||
1599395|NCT02848326|2938835|Superiority||Odds Ratio (OR)|1.83||||0.0113|2-Sided|95.0|1.15|2.91||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures||||
1599396|NCT02848326|2938835|Superiority||Odds Ratio (OR)|1.42||||0.0512|2-Sided|95.0|1.0|2.03||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures||||
1599397|NCT02848326|2938835|Superiority||Odds Ratio (OR)|1.46||||0.0369|2-Sided|95.0|1.02|2.08||GLMM for repeated measures with fixed factors (treatment group, visit), covariates (baseline migraine days), interactions (treatment group by visit; baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures||||
1599398|NCT02848326|2938835|Superiority||Odds Ratio (OR)|1.5||||0.0617|2-Sided|95.0|0.98|2.31||Generalized linear mixed model (GLMM) for repeated measures with fixed factors(treatment group,visit), covariates(baseline migraine days), interactions(treatment group;baseline migraine days by visit) with an unstructured covariance matrix.|GLMM for repeated measures||||
1599399|NCT02848326|2938836|Superiority||Least squares mean difference|-1.39|Standard Error of the Mean|0.44||0.0017|2-Sided|95.0|-2.26|-0.53||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599400|NCT02848326|2938836|Superiority||Least squares mean difference|-1.3|Standard Error of the Mean|0.46||0.0044|2-Sided|95.0|-2.2|-0.41||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599401|NCT02848326|2938836|Superiority||Least squares mean difference|-0.94|Standard Error of the Mean|0.36||0.0087|2-Sided|95.0|-1.64|-0.24||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599402|NCT02848326|2938836|Superiority||Least squares mean difference|-1.24|Standard Error of the Mean|0.36||0.0005|2-Sided|95.0|-1.94|-0.55||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599403|NCT02848326|2938836|Superiority||Least squares mean difference|-1.38|Standard Error of the Mean|0.43||0.0014|2-Sided|95.0|-2.23|-0.54||MMRM model included baseline monthly headache days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599404|NCT02848326|2938837|Superiority||Least squares mean difference|-1.29|Standard Error of the Mean|0.41||0.0016|2-Sided|95.0|-2.09|-0.49||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599405|NCT02848326|2938837|Superiority||Least squares mean difference|-1.39|Standard Error of the Mean|0.42||0.001|2-Sided|95.0|-2.21|-0.56||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599406|NCT02848326|2938837|Superiority||Least squares mean difference|-0.7|Standard Error of the Mean|0.33||0.0325|2-Sided|95.0|-1.35|-0.06||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599407|NCT02848326|2938837|Superiority||Least squares mean difference|-0.91|Standard Error of the Mean|0.33||0.0056|2-Sided|95.0|-1.55|-0.27||MMRM model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599408|NCT02848326|2938837|Superiority||Least squares mean difference|-1.15|Standard Error of the Mean|0.4||0.0039|2-Sided|95.0|-1.93|-0.37||Mixed-effects model for repeated measures (MMRM) model included baseline monthly migraine days as a covariate, treatment group and visit (month) as fixed factors, and treatment group-by-visit and baseline-by-visit as interaction terms.|MMRM||||
1599409|NCT02848222|2938838|Superiority|||||||0.02||||||Threshold for significance was p < 0.05|ANOVA||||
1599410|NCT02847858|2938847|Superiority||Odds Ratio (OR)|1.66||||0.227|2-Sided|95.0|0.73|3.78||Arm main effect; a priori threshold for statistical significance p<.05|Regression, Logistic|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) / Arm2 (Control)|Null hypothesis: No difference between study arms in percentage of participants who receive/make appointment/get prescription for a non-barrier method|
1599411|NCT02847858|2938848|Superiority||Odds Ratio (OR)|2.22||||0.055|2-Sided|95.0|0.98|5.01||Arm main effect; a priori threshold for statistical significance p<.05|Regression, Logistic|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) / Arm2 (Control)|Null hypothesis: No difference between study arms in percentage of participants who discussed birth control with health care provider at visit|
1599412|NCT02847858|2938849|Superiority||Slope|1.62|||<|0.001|2-Sided|95.0|1.43|1.82||Time main effect; a priori threshold for statistical significance p <.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is post-app minus pre-app|Null hypothesis: No change in contraception knowledge from immediate pre-app to immediate post-app among Intervention group participants|
1599413|NCT02847858|2938850|Superiority||Odds Ratio (OR)|5.54||||0.005|2-Sided|95.0|1.7|18.06||Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention / Control; Time comparison is 6 months / Baseline|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 6 months|
1599414|NCT02847858|2938850|Superiority||Odds Ratio (OR)|3.29||||0.042|2-Sided|95.0|1.04|10.36||Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention / Control; Time comparison is 3 months / Baseline|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months|
1599415|NCT02847858|2938850|Superiority||F statistic:Time X Arm Interaction|3.72||||0.025|2-Sided|||||Arm by Time Interaction; a priori threshold for statistical significance p<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|df=2, 1007; Arm comparison is Intervention/Control; Time comparisons are 3 months/Baseline and 6 months/Baseline and 6 months/3 months|Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months or to 6 months|
1599416|NCT02847858|2938851|Superiority||Slope|1.58||||0.008|2-Sided|95.0|0.38|2.77||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Intervention - Control; Time comparison is 6 months - Baseline|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 6 months|
1599417|NCT02847858|2938851|Superiority||Slope|0.82||||0.218|2-Sided|95.0|-0.48|2.11||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site||Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months|Arm comparison is Intervention - Control; Time comparison is 3 months - Baseline
1599418|NCT02847858|2938851|Superiority||F statistic:Time X Arm Interaction|3.23||||0.04|2-Sided|||||Arm by Time interaction; a priori threshold for statistical significance p<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|df=2,1611; Arm comparison is Intervention - Control; Time comparisons are 3 months - Baseline and 6 months - Baseline and 6 months - 3 months|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months or from Baseline to 6 months|
1599419|NCT02847858|2938852|Superiority||Slope|0.48||||0.108|2-Sided|95.0|-0.1|1.05||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome|
1599420|NCT02847858|2938852|Superiority||Slope|1.64|||<|0.001|2-Sided|95.0|1.01|2.07||Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome|
1623037|NCT02289729|2979649|Superiority||||||<|0.0001|||||||t-test||||
1599421|NCT02847858|2938852|Superiority||Slope|1.16|||<|0.011|2-Sided|95.0|0.26|2.07||Arm by Time interaction; a priori threshold for statistical significance p<.05|Mixed Models Analysis|Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site|Arm comparison is Arm 1 (Intervention) minus Arm2 (Control); Time comparison is Post-visit Follow-up minus Baseline|Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to Post-visit Follow-up|
1599422|NCT02847650|2938860|Other||Least Squares Mean Difference|-4.8|Standard Error of the Mean|2.26||0.0407|2-Sided|90.0|-8.6|-1.0|||Mixed Models Analysis||||
1599423|NCT02847637|2938875|Superiority||Mean Difference (Final Values)|-0.13||||0.0059|2-Sided|95.0|-0.23|-0.04||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.||
1599424|NCT02847637|2938875|Superiority||Mean Difference (Final Values)|-0.13||||0.006|2-Sided|95.0|-0.22|-0.04||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.||
1599425|NCT02847637|2938876|Superiority||Mean Difference (Final Values)|-9.15||||0.0373|2-Sided|95.0|-17.74|-0.55||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.||
1599426|NCT02847637|2938876|Superiority||Mean Difference (Final Values)|-4.04||||0.3402|2-Sided|95.0|-12.43|4.35||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.||
1599427|NCT02847637|2938877|Superiority||Mean Difference (Final Values)|8.56||||0.0317|2-Sided|95.0|0.77|16.35||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.||
1599428|NCT02847637|2938877|Superiority||Mean Difference (Final Values)|5.91||||0.1269|2-Sided|95.0|-1.72|13.55||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.||
1599429|NCT02847637|2938878|Superiority||Mean Difference (Final Values)|15.97||||0.0349|2-Sided|95.0|1.16|30.78||Not controlled for type I error|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm B.||
1599430|NCT02847637|2938878|Superiority||Mean Difference (Final Values)|12.51||||0.0891|2-Sided|95.0|-1.96|26.98||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|ANCOVA||The difference in adjusted means was analyzed as Arm C minus Arm A.||
1599431|NCT02847637|2938879|Superiority||ABR Ratio|0.04|||<|0.0001|2-Sided|95.0|0.023|0.068||Not controlled for type I error|Non-stratified Wald test||Arm A+Bnise: Emicizumab Prophylaxis is the numerator and Arm A+Bnise: Pre-Study Episodic FVIII is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.|
1599432|NCT02847637|2938880|Superiority||ABR Ratio|0.03|||<|0.0001|2-Sided|95.0|0.014|0.067||Not controlled for type I error|Non-stratified Wald test||Arm A+Bnise: Emicizumab Prophylaxis is the numerator and Arm A+Bnise: Pre-Study Episodic FVIII is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.|
1599433|NCT02847637|2938881|Superiority||ABR Ratio|0.37||||0.0002|2-Sided|95.0|0.22|0.626||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|Non-stratified Wald test||Dnisp: Emicizumab Prophylaxis is the numerator and Dnisp: Pre-Study FVIII Prophylaxis is the denominator for this ABR ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.|
1599434|NCT02847637|2938882|Superiority||ABR Ratio|0.32|||<|0.0001|2-Sided|95.0|0.195|0.514||Statistical significance is controlled at the 2-sided, 0.05 alpha level.|Non-stratified Wald test||Dnisp: Emicizumab Prophylaxis is the numerator and Dnisp: Pre-Study FVIII Prophylaxis is the denominator for this ABR ratio.|H0 (null hypothesis): ABR Ratio = 1. H1 (alternative hypothesis): ABR Ratio ≠ 1.|
1599435|NCT02847637|2938883|Superiority||ABR Ratio|0.05|||<|0.0001|2-Sided|95.0|0.018|0.147||Not controlled for type I error|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.|
1599436|NCT02847637|2938883|Superiority||ABR Ratio|0.05|||<|0.0001|2-Sided|95.0|0.016|0.143||Not controlled for type I error|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.|
1599437|NCT02847637|2938884|Superiority||ABR Ratio|0.02|||<|0.0001|2-Sided|95.0|0.006|0.056||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.|
1599438|NCT02847637|2938884|Superiority||ABR Ratio|0.06|||<|0.0001|2-Sided|95.0|0.025|0.151||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.|
1599439|NCT02847637|2938885|Superiority||ABR Ratio|0.03|||<|0.0001|2-Sided|95.0|0.015|0.07||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.|
1599440|NCT02847637|2938885|Superiority||ABR Ratio|0.04|||<|0.0001|2-Sided|95.0|0.019|0.085||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value is obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.|
1599480|NCT02842853|2939034|Other||Percentage Difference|2.5|||||2-Sided|95.0|-0.248|5.2||||||Serogroup Y: Lot 1 vs Lot 3|
1599481|NCT02842853|2939034|Other||Percentage Difference|2.0|||||2-Sided|95.0|-0.763|4.79||||||Serogroup Y: Lot 2 vs Lot 3|
1599441|NCT02847637|2938886|Superiority||ABR Ratio|0.06|||<|0.0001|2-Sided|95.0|0.03|0.103||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.|
1599442|NCT02847637|2938886|Superiority||ABR Ratio|0.05|||<|0.0001|2-Sided|95.0|0.028|0.099||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.|
1599443|NCT02847637|2938887|Superiority||ABR Ratio|0.03|||<|0.0001|2-Sided|95.0|0.017|0.066||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm B is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm B versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm B versus Arm C ≠ 1.|
1599444|NCT02847637|2938887|Superiority||ABR Ratio|0.04|||<|0.0001|2-Sided|95.0|0.02|0.075||Statistical significance is controlled at the 2-sided, 0.05 alpha level. The p-value was obtained via a global model with a 3-level categorical effect for treatment (emicizumab 1.5 mg/kg/week, emicizumab 3 mg/kg/2 weeks, or no prophylaxis).|Stratified Wald test||Arm A is the numerator and Arm C is the denominator for this ABR Ratio.|H0 (null hypothesis): ABR Ratio for Arm A versus Arm C = 1. H1 (alternative hypothesis): ABR Ratio for Arm A versus Arm C ≠ 1.|
1599445|NCT02847182|2938932|Superiority||Mean Difference (Final Values)|1.14||||0.83|2-Sided|95.0|-1.58|3.86|||t-test, 2 sided|||Null hypothesis: The mean of the 6-month change in VABS-II Socialization Subscale Standard Score is the same for the Cord Blood and Placebo groups.|
1599446|NCT02846779|2938947|Superiority||Risk Ratio (RR)|1.14|||||2-Sided|95.0|0.99|1.32|||||||
1599447|NCT02846779|2938947|Superiority||Risk Ratio (RR)|1.22|||||2-Sided|95.0|1.06|1.41|||||||
1599448|NCT02846779|2938948|Superiority||Risk Ratio (RR)|0.96|||||2-Sided|95.0|0.85|1.07|||||||
1599449|NCT02846779|2938948|Superiority||Risk Ratio (RR)|1.38|||||2-Sided|95.0|1.24|1.53|||||||
1599450|NCT02846779|2938949|Superiority||Risk Ratio (RR)|0.98|||||2-Sided|95.0|0.96|1.0|||||||
1599451|NCT02846779|2938949|Superiority||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.97|1.02|||||||
1599452|NCT02846779|2938950|Superiority||Risk Ratio (RR)|0.99|||||2-Sided|95.0|0.92|1.06|||||||
1599453|NCT02846779|2938950|Superiority||Risk Ratio (RR)|1.03|||||2-Sided|95.0|0.95|1.11|||||||
1599454|NCT02846779|2938951|Superiority||Risk Difference (RD)|-0.25|||||2-Sided|95.0|-0.43|-0.06|||||||
1599455|NCT02846779|2938951|Superiority||Risk Difference (RD)|-0.15|||||2-Sided|95.0|-0.34|0.05|||||||
1599456|NCT02846779|2938952|Superiority||Risk Ratio (RR)|0.91|||||2-Sided|95.0|0.77|1.06|||||||
1599457|NCT02846779|2938952|Superiority||Risk Ratio (RR)|0.88|||||2-Sided|95.0|0.75|1.03|||||||
1599458|NCT02845700|2938977|Superiority|||||||0.54|||||||t-test, 2 sided|t(4) = 0.66, p = .54||Post-hoc estimates of observed power for the difference between group means was calculated to be .08.|
1599459|NCT02845700|2938980|Superiority|||||||0.39|||||||t-test, 2 sided|t(4) = -1.19, p = .39||Post-hoc estimates of observed power for the difference between group means was calculated to be .15.|
1599460|NCT02845700|2938981|Superiority|||||||0.08|||||||ANOVA|2 (time) x 2 (group) x 5 (dilution %) repeated measures ANOVA|||
1599461|NCT02845375|2938983|Superiority|||||||0.299|||||||ANCOVA||||
1599462|NCT02844569|2938996|Superiority|||||||0.66|||||||t-test, 2 sided||||
1599463|NCT02844569|2938997|Superiority||||||<|0.01|||||||Mixed Models Analysis||||
1599464|NCT02844569|2938998|Superiority|||||||0.11|||||||t-test, 2 sided||||
1599465|NCT02842866|2939031|Other||GMT Ratio|1.81|||||2-Sided|95.0|1.42|2.31||||||Serogroup W|
1599466|NCT02842866|2939031|Other||GMT Ratio|3.3|||||2-Sided|95.0|2.57|4.23||||||Serogroup Y|
1599467|NCT02842866|2939031|Other||GMT Ratio|4.1|||||2-Sided|95.0|3.16|5.33||||||Serogroup C|
1599468|NCT02842866|2939031|Other||GMT Ratio|1.75|||||2-Sided|95.0|1.4|2.2||||||Serogroup A|
1599469|NCT02842866|2939032|Non-Inferiority|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all four serogroups.|Difference in percentage|17.8|||||2-Sided|95.0|11.2|24.2||||||Serogroup W|
1599470|NCT02842866|2939032|Non-Inferiority|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all four serogroups.|Difference in percentage|31.0|||||2-Sided|95.0|24.6|37.0||||||Serogroup Y|
1599471|NCT02842866|2939032|Non-Inferiority|The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all four serogroups.|Difference in percentage|27.5|||||2-Sided|95.0|21.2|33.5||||||Serogroup C|
1599472|NCT02842866|2939032|Non-Inferiority|The 95 percent (%) confidence internal (CI) of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was greater than (>) -10 percent (%) for all four serogroups.|Difference in percentage|15.7|||||2-Sided|95.0|9.08|22.2||||||Serogroup A|
1599473|NCT02842853|2939033|Other||GMT Ratio|1.9|||||2-Sided|95.0|1.61|2.24||||||Serogroup W|
1599474|NCT02842853|2939033|Other||GMT Ratio|3.22|||||2-Sided|95.0|2.71|3.84||||||Serogroup Y|
1599475|NCT02842853|2939033|Other||GMT Ratio|8.05|||||2-Sided|95.0|6.58|9.84||||||Serogroup C|
1599476|NCT02842853|2939033|Other||GMT Ratio|1.93|||||2-Sided|95.0|1.67|2.24||||||Serogroup A|
1602233|NCT02756689|2943613|Superiority|||||||0.83|||||||Wilcoxon (Mann-Whitney)||||
1599484|NCT02842853|2939034|Other||Percentage Difference|2.4|||||2-Sided|95.0|-0.74|5.54||||||Serogroup C: Lot 2 vs Lot 3|
1599485|NCT02842853|2939034|Other||Percentage Difference|1.3|||||2-Sided|95.0|-1.58|4.28||||||Serogroup C: Lot 1 vs Lot 2|
1599486|NCT02842853|2939034|Other||Percentage Difference|-2.5|||||2-Sided|95.0|-6.78|1.74||||||Serogroup A: Lot 1 vs Lot 3|
1599487|NCT02842853|2939034|Other||Percentage Difference|2.9|||||2-Sided|95.0|-1.3|7.01||||||Serogroup A: Lot 2 vs Lot 3|
1599488|NCT02842853|2939034|Other||Percentage Difference|-5.4|||||2-Sided|95.0|-9.59|-1.16||||||Serogroup A: Lot 1 vs Lot 2|
1599489|NCT02842853|2939035|Non-Inferiority|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.|Percentage Difference|12.5|||||2-Sided|95.0|7.22|18.2||||||Serogroup W|
1599490|NCT02842853|2939035|Non-Inferiority|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.|Percentage Difference|10.0|||||2-Sided|95.0|6.18|14.5||||||Serogroup Y|
1599491|NCT02842853|2939035|Non-Inferiority|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.|Percentage Difference|42.3|||||2-Sided|95.0|36.6|48.0||||||Serogroup C|
1599492|NCT02842853|2939035|Non-Inferiority|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.|Percentage Difference|18.7|||||2-Sided|95.0|12.5|24.9||||||Serogroup A|
1599493|NCT02842853|2939036|Non-Inferiority|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.|Percentage Difference|26.8|||||2-Sided|95.0|20.7|32.9||||||Serogroup W|
1599494|NCT02842853|2939036|Non-Inferiority|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.|Percentage Difference|27.4|||||2-Sided|95.0|21.7|33.3||||||Serogroup Y|
1599495|NCT02842853|2939036|Non-Inferiority|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.|Percentage Difference|41.1|||||2-Sided|95.0|35.0|46.9||||||Serogroup C|
1599496|NCT02842853|2939036|Non-Inferiority|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.|Percentage Difference|19.6|||||2-Sided|95.0|13.5|25.8||||||Serogroup A|
1599497|NCT02842853|2939037|Non-Inferiority|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.|Percentage Difference|19.1|||||2-Sided|95.0|14.9|23.3||||||Serogroup W|
1599498|NCT02842853|2939037|Non-Inferiority|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.|Percentage Difference|18.1|||||2-Sided|95.0|14.5|21.9||||||Serogroup Y|
1599499|NCT02842853|2939037|Non-Inferiority|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.|Percentage Difference|40.9|||||2-Sided|95.0|36.7|45.0||||||Serogroup C|
1599500|NCT02842853|2939037|Non-Inferiority|95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.|Percentage Difference|19.1|||||2-Sided|95.0|14.8|23.5||||||Serogroup A|
1599501|NCT02842853|2939038|Equivalence|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.97|||||2-Sided|95.0|0.818|1.15||||||Serogroup W: Lot 1 vs Lot 3|
1599502|NCT02842853|2939038|Equivalence|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.936|||||2-Sided|95.0|0.791|1.11||||||Serogroup W: Lot 2 vs Lot 3|
1599503|NCT02842853|2939038|Equivalence|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.04|||||2-Sided|95.0|0.878|1.22||||||Serogroup W: Lot 1 vs Lot 2|
1599504|NCT02842853|2939038|Equivalence|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.975|||||2-Sided|95.0|0.829|1.15||||||Serogroup Y: Lot 1 vs Lot 3|
1599505|NCT02842853|2939038|Equivalence|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.961|||||2-Sided|95.0|0.816|1.13||||||Serogroup Y: Lot 2 vs Lot 3|
1599506|NCT02842853|2939038|Equivalence|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.02|||||2-Sided|95.0|0.869|1.19||||||Serogroup Y: Lot 1 vs Lot 2|
1599507|NCT02842853|2939038|Equivalence|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.927|||||2-Sided|95.0|0.766|1.12||||||Serogroup C: Lot 1 vs Lot 3|
1599508|NCT02842853|2939038|Equivalence|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.866|||||2-Sided|95.0|0.714|1.05||||||Serogroup C: Lot 2 vs Lot 3|
1599509|NCT02842853|2939038|Equivalence|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|1.07|||||2-Sided|95.0|0.888|1.29||||||Serogroup C: Lot 1 vs Lot 2|
1599510|NCT02842853|2939038|Equivalence|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.867|||||2-Sided|95.0|0.74|1.02||||||Serogroup A: Lot 1 vs Lot 3|
1599511|NCT02842853|2939038|Equivalence|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.985|||||2-Sided|95.0|0.843|1.15||||||Serogroup A: Lot 2 vs Lot 3|
1599512|NCT02842853|2939038|Equivalence|Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% Confidence Interval (CI) for the ratio of the GMTs lies between 1/2 and 2.|GMT Ratio|0.88|||||2-Sided|95.0|0.751|1.03||||||Serogroup A: Lot 1 vs Lot 2|
1599513|NCT02842151|2939054|Equivalence|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Net)|-0.13|Standard Deviation|0.34|||2-Sided|90.0|-0.22|-0.04||||||To demonstrate equivalency at Site 3, A-constant with manifest refraction was compared to A-constant with autorefraction.|
1599514|NCT02842151|2939054|Equivalence|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Net)|-0.07|Standard Deviation|0.595|||2-Sided|90.0|-0.21|0.07||||||To demonstrate equivalency at Site 2, A-constant with manifest refraction was compared to A-constant with autorefraction.|
1599515|NCT02842151|2939054|Equivalence|Difference in A-Constant is manifest refraction minus autorefraction. The criteria for equivalence (based on paired difference t-test) was established if the bounds of the 90% two-sided confidence interval (CI) on the difference was contained within the equivalence range (-0.15, 0.15).|Mean Difference (Final Values)|0.05|Standard Deviation|0.346|||2-Sided|90.0|-0.03|0.13||||||To demonstrate equivalency at Site 1, A-constant with manifest refraction was compared to A-constant with autorefraction.|
1599516|NCT02842086|2939057|Superiority||Difference in LSM|-0.01|||<|0.001|2-Sided|95.0|-0.02|-0.01|||ANCOVA|||Results were compared between the 2 treatment groups using the ANCOVA model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.|
1599517|NCT02842086|2939058|Superiority|||||||0.56||||||P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus > 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.|Rank analysis of covariance||||
1599518|NCT02842086|2939059|Superiority||||||<|0.001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test||||
1599519|NCT02842086|2939060|Superiority||||||<|0.001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test||||
1599520|NCT02842086|2939061|Superiority||Difference in LSM|2.115|||<|0.001|2-Sided|95.0|1.152|3.078|||ANOVA|||Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.|
1599521|NCT02842086|2939062|Superiority||Difference in LSM|1.602|||<|0.001|2-Sided|95.0|0.848|2.357|||ANOVA|||Hip BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.|
1599522|NCT02842086|2939064|Superiority||Difference in LSM|-0.02|||<|0.001|2-Sided|95.0|-0.02|-0.01|||ANCOVA|||Results were compared between the 2 treatment groups using the analysis of covariance (ANCOVA) model including baseline TVD for PrEP and treatment as fixed effects and baseline serum creatinine as a covariate.|
1599523|NCT02842086|2939065|Superiority|||||||0.005||||||P-value for difference between treatment groups in distributions of UPCR ≤ 200 mg/g versus > 200 mg/g was from the rank analysis of covariance adjusting for baseline category and baseline TVD for PrEP.|Rank analysis of covariance||||
1599524|NCT02842086|2939066|Superiority||||||<|0.001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test||||
1599525|NCT02842086|2939067|Superiority||||||<|0.001||||||P-values were from the Van Elteren test stratified by baseline TVD for PrEP.|Van Elteren test||||
1599526|NCT02842086|2939068|Superiority||Difference in LSM|1.609|||<|0.001|2-Sided|95.0|0.955|2.264|||ANOVA|||Spine BMD results were compared between the 2 treatment groups using ANOVA, which included baseline TVD for PrEP and treatment as fixed effects.|
1599527|NCT02842086|2939069|Superiority||Difference in least squares mean (LSM)|1.123|||<|0.001|2-Sided|95.0|0.608|1.638|||ANOVA|||Hip BMD results were compared between the 2 treatment groups using analysis of variance (ANOVA), which included baseline TVD for pre-exposure prophylaxis (PrEP) and treatment as fixed effects.|
1599528|NCT02842086|2939070|Non-Inferiority|Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.|Rate Ratio|0.468|||||2-Sided|95.003|0.191|1.149||||||Noninferiority was assessed using a 95% confidence interval (CI) constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.|
1599529|NCT02841787|2939080|Superiority|||||||0.003||||||The threshold for significance was alpha=0.05.|t-test, 2 sided||||
1599530|NCT02841787|2939083|Superiority|||||||0.03||||||The threshold for significance was alpha=0.05.|t-test, 2 sided||||
1599531|NCT02841787|2939083|Superiority|||||||0.02||||||The threshold for significance was alpha=0.05.|t-test, 2 sided||||
1599532|NCT02841787|2939083|Superiority|||||||0.68||||||The threshold for significance was alpha=0.05.|t-test, 2 sided||||
1599533|NCT02841787|2939083|Superiority|||||||0.03||||||The threshold for significance was alpha=0.05.|ANOVA||||
1599534|NCT02841787|2939083|Superiority|||||||0.44||||||The threshold for significance was alpha=0.05.|t-test, 2 sided||||
1599535|NCT02841787|2939083|Superiority||||||<|0.001||||||The threshold for significance was alpha=0.05.|t-test, 2 sided||||
1599536|NCT02841787|2939083|Superiority||||||<|0.001||||||The threshold for significance was alpha=0.05.|t-test, 2 sided||||
1599537|NCT02841709|2939085|Other||LS mean difference|-47.8|Standard Error of the Mean|4.74|<|0.001|2-Sided|95.0|-57.2|-38.5|||Linear mixed effects model||||
1599538|NCT02841709|2939085|Other||LS mean difference|-31.5|Standard Error of the Mean|4.74|<|0.001|2-Sided|95.0|-40.9|-22.2|||Linear mixed effects model||||
1599539|NCT02841709|2939085|Other||LS mean difference|-18.4|Standard Error of the Mean|4.76|<|0.001|2-Sided|95.0|-27.8|-9.0|||Linear mixed effects model||Parameter Dispersion Type: Standard Error of the LS Mean||
1599540|NCT02841709|2939085|Other||LS mean difference|-5.4|Standard Error of the Mean|4.73|<|0.258|2-Sided|95.0|-14.7|4.0|||Linear mixed effects model||Parameter Dispersion Type: Standard Error of the LS Mean||
1599541|NCT02841709|2939085|Other||||||<|0.001|||||||Multiple Comparison Procedure-Model|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose response across placebo and all ACT-541468 doses. The null hypothesis of no dose response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value <0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.)"|
1599542|NCT02839902|2939137|Other|Least square (LS) mean difference|Least square (LS) mean difference|0.838||||0.036|2-Sided|95.0|0.057|1.62|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by phospholipid using an ANCOVA model.|
1599543|NCT02839902|2939137|Other|Least square (LS) mean difference|Least square (LS) mean difference|0.76||||0.057|2-Sided|95.0|-0.024|1.544|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by free cholesterol using an ANCOVA model.|
1599544|NCT02839902|2939137|Other|Least square (LS) mean difference|Least square (LS) mean difference|1.553||||0.4428|2-Sided|95.0|-2.884|5.991|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by triglycerides using an ANCOVA model.|
1599545|NCT02839902|2939137|Other|Least square (LS) mean difference|Least square (LS) mean difference|1.066||||0.004|2-Sided|95.0|0.356|1.776|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with particle size (nm) of LDL at Week 8 monitored by cholesterol using an ANCOVA model.|
1599546|NCT02839902|2939138|Other|Least square (LS) mean difference|Least square (LS) mean difference|9.499||||0.1826|2-Sided|95.0|-4.623|23.622|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with TG to cholesterol ratio in sd LDL fraction at Week 8 using an ANCOVA model.|
1599547|NCT02839902|2939139|Other|Least square (LS) mean difference|Least square (LS) mean difference|-11.511||||0.0047|2-Sided|95.0|-19.34|-3.682|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with phospholipid concentration in sd LDL fraction at Week 8 using an ANCOVA model.|
1599548|NCT02839902|2939139|Other|Least square (LS) mean difference|Least square (LS) mean difference|-10.246||||0.0248|2-Sided|95.0|-19.143|-1.349|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with free cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.|
1599549|NCT02839902|2939139|Other|Least square (LS) mean difference|Least square (LS) mean difference|-9.774||||0.1141|2-Sided|95.0|-21.986|2.439|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with triglycerides concentration in sd LDL fraction at Week 8 using an ANCOVA model.|
1599550|NCT02839902|2939139|Other|Least square (LS) mean difference|Least square (LS) mean difference|-17.147||||0.0004|2-Sided|95.0|-26.344|-7.95|||ANCOVA||TAK-085 4 g - Control Group|The least square (LS) mean percentage change was compared between treatment groups with cholesterol concentration in sd LDL fraction at Week 8 using an ANCOVA model.|
1599551|NCT02839772|2939188|Superiority or Other||Mean Difference (Final Values)|-0.063|Standard Error of the Mean|0.54||0.907|2-Sided|95.0|-1.129|1.002|||Mixed Models Analysis|t=-0.117, df=178.814||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Podoconiosis has a large effect on a person's quality of life. abnormal looking legs/feet, wounds and the related bad odour plus social isolation result in stigma and social isolation.."|
1599552|NCT02839772|2939189|Superiority or Other||Mean Difference (Final Values)|0.575|Standard Error of the Mean|0.162|<|0.001|2-Sided|95.0|0.255|0.895|||Mixed Models Analysis|df=169.916, t=3.550||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in foot circumference indicates an improvement in the disease."|
1599553|NCT02839772|2939190|Superiority or Other||Median Difference (Final Values)|0.288|Standard Error of the Mean|0.204||0.158|2-Sided|95.0|-0.113|0.69|||Mixed Models Analysis|df=185.386||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~A reduction in leg circumference indicates an improvement in the disease."|
1599554|NCT02839772|2939191|Superiority or Other||||||<|0.001||||||The p value was < 0.001 at all time points.|Spearman's correlation coefficient|The correlation at the 1st visit was 0.252, at the 2nd 0.306, at the 3rd 0.291 and at the 4th 0.265.||The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.|
1599566|NCT02839772|2939203|Superiority or Other||Mean Difference (Final Values)|1.684|Standard Error of the Mean|0.346|<|0.001|2-Sided|95.0|1.002|2.367|||Mixed Models Analysis|t=4.871, df=189.789||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the mid-point of the outer lower legs by group from baseline after 3 months of interventions."|
1623038|NCT02289729|2979650|Superiority||||||<|0.0001|||||||t-test||||
1599555|NCT02839772|2939192|Superiority or Other||Group ratio estimate|2.09|Standard Error of the Mean|1.102||0.058|2-Sided|0.058|-0.069|4.25||A Poisson distribution with a logarithmic link function was used.|Generalized estimation equation|df=1|Those in the experimental group were expected to have fewer work days lost due to ADL.|"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds by group of having had fewer work days lost in the previous month at the 4th visit due to ADL."|
1599556|NCT02839772|2939193|Superiority or Other||Odds Ratio, log|2.062|Standard Error of the Mean|0.741||0.005|2-Sided|95.0|0.61|3.514||A Poisson distribution with a logarithmic link function was used|Generalized estimating equation analysis|Wald chi-square=7.745, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of wounds being present on the lower legs/feet of participants by group at the 4th visit."|
1599557|NCT02839772|2939194|Superiority or Other||Odds Ratio, log|-1.29|Standard Error of the Mean|0.446||0.031|2-Sided|95.0|-2.161|-0.411||A Bernouilli distribution with a logistic link function was used|Generalized estimating equation analysis|Wald chi-square=8.304, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of participants having a bad odour emanating from their lower legs/feet by group at the 4th visit. Bad odour results in a decease in quality of life."|
1599558|NCT02839772|2939195|Superiority or Other||Odds Ratio, log|-0.224||||0.527|2-Sided|95.0|-0.469|0.917||A Bernouilli distribution with a logistic link function was used.|Generalized estimating equation analysis|Wald chi-square=0.410, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of mossy changes being present in the lower legs/feet by group at the 4th visit."|
1599559|NCT02839772|2939196|Superiority or Other||Odds Ratio, log|0.452|Standard Error of the Mean|0.255||0.076|2-Sided|95.0|-0.048|0.952||A cumulative logistic link function was used|Generalized estimating equation analysis|Wald Chi squared=3.138, df=1||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis calculated the odds of the stage of podoconiosis by group being more severe at the 4th visit."|
1599560|NCT02839772|2939197|Superiority or Other||Mean Difference (Final Values)|-2.041|Standard Error of the Mean|0.572|<|0.001|2-Sided|95.0|-3.168|-0.911|||Mixed Models Analysis|t=-3.565, df=186.739||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the top of the feet by group from baseline after 3 months of interventions."|
1599561|NCT02839772|2939198|Superiority or Other||Mean Difference (Final Values)|-1.641|Standard Error of the Mean|0.473||0.001|2-Sided|95.0|-2.574|-0.708|||Mixed Models Analysis|t=-3.471, df=186.308||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the base of the outer lower legs by group from baseline after 3 months of interventions."|
1599562|NCT02839772|2939199|Superiority or Other||Mean Difference (Final Values)|-1.658|Standard Error of the Mean|0.467|<|0.001|2-Sided|95.0|-2.581|-0.736|||Mixed Models Analysis|t=-3.549, df=180.923||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the mid-point of the outer lower legs by group from baseline after 3 months of interventions."|
1599563|NCT02839772|2939200|Superiority or Other||Mean Difference (Final Values)|-2.075|Standard Error of the Mean|0.515|<|0.001|2-Sided|95.0|-3.042|-1.1078|||Mixed Models Analysis|t=-4.236,df=165.310||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in SCH at the top of the outer lower legs by group from baseline after 3 months of interventions."|
1599564|NCT02839772|2939201|Superiority or Other||Mean Difference (Final Values)|1.751|Standard Error of the Mean|0.39||0.002|2-Sided|95.0|0.656|2.846|||Mixed Models Analysis|t=3.154, df=189.580||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the feet by group from baseline after 3 months of interventions."|
1599565|NCT02839772|2939202|Superiority or Other||Mean Difference (Final Values)|1.97|Standard Error of the Mean|0.386|<|0.001|2-Sided|95.0|1.21|2.731|||Mixed Models Analysis|t=5.111, df=189.620||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the base of the outer lower legs by group from baseline after 3 months of interventions."|
1599627|NCT02833350|2939498|Superiority||Adjusted Difference|2.05||||0.6564|2-Sided|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1623039|NCT02289729|2979651|Superiority||||||<|0.0001|||||||t-test||||
1599567|NCT02839772|2939204|Superiority or Other||Mean Difference (Final Values)|1.581|Standard Error of the Mean|0.296|<|0.001|2-Sided|95.0|0.997|2.164|||Mixed Models Analysis|t=5.341, df=89.347||"The null hypothesis was that an evidence-based skin care intervention with added glycerine does not improve skin barrier function (SBF) in the legs/feet or enhance the disease related quality of life of Ethiopian people with podoconiosis when compared to the control group using the current skin care regimen.~Statistical analysis compared the changes in TEWL at the top of the outer lower legs by group from baseline after 3 months of interventions."|
1599568|NCT02839746|2939213|Other||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of visit 2 satisfaction with that of Visit 3.|
1599569|NCT02839746|2939213|Other||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of visit 2 convenience with that of Visit 3.|
1599570|NCT02839746|2939214|Other|Within group comparison of Baseline satisfaction with that of Visit 3.|||||<|0.0001|||||||non-parametric Wilcoxon signed-rank]||||
1599571|NCT02839746|2939214|Other||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline convenience with that of Visit 3.|
1599572|NCT02839746|2939215|Other||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline satisfaction with that of Visit 2.|
1599573|NCT02839746|2939215|Other||||||<|0.0001|||||||non-parametric Wilcoxon signed-rank|||Within group comparison of Baseline convenience with that of Visit 2.|
1599574|NCT02839330|2939233|Equivalence|Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|0.97|||||2-Sided|95.0|0.87|1.09||||||aH5N1c Lot #1 vs. aH5N1c Lot #3|
1599575|NCT02839330|2939233|Equivalence|Equivalence margin: The 2-sided 95% CIs of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|0.96|||||2-Sided|95.0|0.86|1.08||||||aH5N1c Lot #2 vs. aH5N1c Lot #3|
1599576|NCT02839330|2939233|Equivalence|Equivalence margin: The 2-sided 95% confidence interval (CI) of all the 3 pairwise comparisons of GMTs to fall between the predefined equivalence ranges of 0.667 and 1.5|GMT ratio|1.01|||||2-Sided|95.0|0.9|1.13||||||aH5N1c Lot #1 vs. aH5N1c Lot #2|
1599577|NCT02839200|2939237|Other||LS Mean difference|-8.5|Standard Error of the Mean|5.97||0.155|2-Sided|95.0|-20.4|3.3|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean||
1599578|NCT02839200|2939237|Other||LS Mean difference|-25.6|Standard Error of the Mean|5.92|<|0.001|2-Sided|95.0|-37.3|-13.9|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean||
1599579|NCT02839200|2939237|Other||LS Mean difference|-16.2|Standard Error of the Mean|5.95|<|0.007|2-Sided|95.0|-27.9|-4.5|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean||
1599580|NCT02839200|2939237|Other||LS Mean difference|-10.8|Standard Error of the Mean|6.0|<|0.072|2-Sided|95.0|-22.6|1.0|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean||
1599581|NCT02839200|2939237|Other||LS mean difference|-7.0|Standard Error of the Mean|5.95|<|0.241|2-Sided|95.0|-18.7|4.7|||ANCOVA||Parameter Dispersion Type and Dispersion Value: Standard error of the LS mean||
1599582|NCT02839200|2939237|Other||||||<|0.001|||||||Multiple Comparison Procedure-Model|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all ACT-541468 doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value <0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cranrprojects.org/web/packages/DoseFinding.)"|
1599583|NCT02838901|2939238|Other|||||||0.185|||||||Wilcoxon (Mann-Whitney)||||
1599584|NCT02838901|2939239|Other|||||||0.135|||||||Wilcoxon (Mann-Whitney)||||
1599585|NCT02838901|2939240|Other|||||||0.475|||||||Wilcoxon (Mann-Whitney)||||
1599586|NCT02838901|2939241|Other|||||||0.888|||||||Wilcoxon (Mann-Whitney)||||
1599587|NCT02838901|2939242|Other|||||||0.532|||||||Wilcoxon (Mann-Whitney)||||
1599588|NCT02838901|2939242|Other|||||||0.889|||||||Wilcoxon (Mann-Whitney)||||
1599589|NCT02838901|2939243|Other|||||||0.876|||||||Wilcoxon (Mann-Whitney)||||
1599590|NCT02838901|2939243|Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1599591|NCT02838901|2939245|Other|||||||0.6678|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was assumed, and no power calculation was performed since this was a pilot study and the purpose was to collect preliminary data for a larger trial.|
1599592|NCT02838901|2939245|Other|This was a descriptive analysis for a pilot study to gather preliminary data for a larger trial. No power calculations were performed for this outcome.||||||0.9581|||||||Wilcoxon (Mann-Whitney)||||
1599593|NCT02838901|2939246|Other|This was a descriptive analysis for a pilot study, and no power calculations were performed.||||||0.1023|||||||Wilcoxon (Mann-Whitney)||||
1599594|NCT02838901|2939247|Other|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was assumed, and no power calculation was performed since this was a pilot study.|
1599595|NCT02838901|2939248|Other|This was a descriptive analysis and was under the goal of assessing safety of the intervention.||||||1|||||||Fisher Exact|||Null hypothesis was assumed, no power calculation was done since this was a pilot study.|
1599596|NCT02838901|2939249|Other|This was a descriptive analysis, and was based on the overall assessment of feasibility of the intervention.||||||0.058||||||The p value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||The null hypothesis was used, and the assumption was there would be no difference in adherence between the Active Juice and the Placebo Juice, and therefore a two-sided t approximation was reported. Since this was a pilot study, power calculations were not performed. The adherence in the two groups was compared using the Wilcoxon two-sample test.|
1599597|NCT02837952|2939326|Superiority||||||<|0.001||||||P-value Method was based on Gehan-Wilcoxon test, stratified by sex and baseline categorical PSR.|Gehan-Wilcoxon test||||
1599598|NCT02837952|2939327|Superiority||||||<|0.001||||||P-value Method was based on Gehan-Wilcoxon test, stratified by sex and baseline categorical PSR.|Gehan-Wilcoxon test||||
1599599|NCT02837952|2939328|Superiority||LS Mean Difference|138.65|||<|0.001|2-Sided|95.0|91.045|186.261|||ANCOVA|||0 to 48 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1599600|NCT02837952|2939328|Superiority||LS Mean Difference|27.32|||<|0.001|2-Sided|95.0|18.139|36.508|||ANCOVA|||8 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1599601|NCT02837952|2939328|Superiority||LS Mean Difference|51.67|||<|0.001|2-Sided|95.0|37.075|66.258|||ANCOVA|||0 to 16 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1599602|NCT02837952|2939328|Superiority||LS Mean Difference|7.91|||<|0.001|2-Sided|95.0|5.196|10.632|||ANCOVA|||6 to 8 hours: Treatment difference and 95% CI were based on LS mean from ANCOVA with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1599603|NCT02837952|2939328|Superiority||Least Square Mean Difference|26.45|||<|0.001|2-Sided|95.0|19.895|33.005|||ANCOVA|||0 to 8 hours: Treatment difference and 95% CI were based on least square (LS) mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical PSR as classification variables and baseline numerical PSR used as a continuous covariate.|
1599604|NCT02837952|2939329|Superiority||Least Square Mean Difference|72.89|||<|0.001|2-Sided|95.0|50.075|95.707|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on LS Mean from analysis of covariance (ANCOVA) with treatment, gender, baseline categorical pain severity rating (PSR) as classification variables and baseline numerical PSR used as a continuous covariate.|
1599605|NCT02836496|2939345|Superiority|||||||0.036|||||||Wilcoxon Rank Sum Test|P-value was calculated using Wilcoxon Rank Sum Test|||
1599606|NCT02836496|2939346|Superiority||Rate Ratio|0.34||||0.002|2-Sided|95.0|0.19|0.63|||Wilcoxon Rank Sum Test|Wilcoxon test stratified by Baseline OCS (0-<=20 mg/day, >20 mg/day prednisone or equivalent) and region.|Treatment comparison between placebo and mepolizumab 300 mg using rate ratio and 95% CI has been presented. Rate ratio <1 indicates a lower flare rate with Mepolizumab compared with Placebo.||
1599607|NCT02836496|2939347|Superiority||Hazard Ratio (HR)|0.34||||0.002|2-Sided|95.0|0.18|0.67||Cox proportional hazards regression analysis adjusted for Baseline OCS dose and region.|Regression, Cox||Treatment comparison between placebo and mepolizumab 300 mg using hazards ratio and its corresponding 95% CI has been presented. Hazard ratio <1 indicated a lower risk of HES flare with Mepolizumab compared with Placebo.||
1599608|NCT02836496|2939348|Superiority||Odds Ratio (OR)|0.33||||0.022|2-Sided|95.0|0.13|0.85|||Regression, Logistic|Logistic regression analysis adjusted for Baseline OCS dose and region|Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% CI has been presented. Odds ratio <1 indicated lower odds of HES flare with Mepolizumab compared with placebo.||
1599609|NCT02836496|2939348|Superiority|||||||0.02|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Baseline OCS (0-<=20 mg per day and >20mg perday prednisone or equivalent) and region|||
1599610|NCT02836496|2939349|Superiority||Odds Ratio (OR)|0.28||||0.003|2-Sided|95.0|0.12|0.64|||Regression, Logistic|Logistic regression analysis adjusted for Baseline OCS dose and region.|Treatment comparison between placebo and mepolizumab 300 mg using odds ratio and 95% confidence interval (CI) has been presented. Odds ratio <1 indicated lower odds of HES flare with Mepolizumab compared with placebo.||
1599611|NCT02836496|2939349|Superiority|||||||0.002||||||Cochran-Mantel-Haenszel test stratified by Baseline oral corticosteroid (OCS) (0-<=20 mg per day and >20mg perday prednisone or equivalent) and region|Cochran-Mantel-Haenszel||||
1599612|NCT02834663|2939416|Superiority||Mean Difference (Final Values)|0.021|Standard Deviation|1.87||0.221|2-Sided|95.0|-0.751|0.795||The threshold for statistical significance was p < 0.05|t-test, 2 sided||||
1599613|NCT02834663|2939417|Superiority||Mean Difference (Final Values)|5.64|Standard Deviation|7.21||0.0001|2-Sided|95.0|2.67|8.62||The threshold for statistical significance was p < 0.05|t-test, 2 sided||||
1599614|NCT02834663|2939418|Superiority||Mean Difference (Final Values)|5.64|Standard Deviation|7.21||0.0001|2-Sided|95.0|2.67|8.62||The threshold for statistical significance was p < 0.05|t-test, 2 sided||||
1599615|NCT02834663|2939419|Superiority||Mean Difference (Final Values)|2.23|Standard Deviation|2.24||0.0001|2-Sided|95.0|1.3|3.15||The threshold for statistical significance was p < 0.05|t-test, 2 sided||||
1599616|NCT02834663|2939420|Superiority||Mean Difference (Final Values)|3.92|Standard Deviation|4.932||0.001|2-Sided|95.0|1.884|5.956||The threshold for statistical significance was p < 0.05|t-test, 2 sided||||
1599617|NCT02834663|2939421|Superiority||Mean Difference (Final Values)|110.0|Standard Deviation|65.919||0.0001|2-Sided|95.0|82.79|137.21||The threshold for statistical significance was p < 0.05|t-test, 2 sided||||
1599618|NCT02834663|2939422|Superiority||Mean Difference (Final Values)|-8.76|Standard Deviation|12.521|<|0.0001|2-Sided|95.0|-13.928|-3.592||The threshold for statistical significance was p < 0.05|t-test, 2 sided|||Patients were evaluated for changes in BCVA of the treated eye, from the start of the study till 6 months, until trial completion. After administration of each injection, measurements of BCVA were compared to their respective baseline results. The paired t-test and repeated measures ANOVA was performed for comparative analysis, as all showed normality.|
1599619|NCT02834624|2939423|Other|||||||0.63|||||||t-test, 1 sided||||
1599620|NCT02834624|2939425|Other||||||<|0.05|||||||t-test, 1 sided|||Sample size calculations used a Chi-square for independence, u = 1, p =.05, power = .80, effect size = .60, which required 22 total subjects.|
1599621|NCT02833948|2939453|Superiority|||||||0.01|||||||Fisher Exact||||
1599622|NCT02833948|2939457|Superiority|||||||0.01|||||||Fisher Exact|The Fisher’s exact probability test was used to compare the percentages of patients with the primary end point between the treatment groups.|||
1599623|NCT02833415|2939485|Other|Differences of Least Squares Means|Differences of Least Squares Means|0.152|Standard Error of the Mean|0.2424||0.5394|2-Sided||||||Mixed Models Analysis|||Baseline to Followup|
1599624|NCT02833415|2939485|Other|Differences of Least Squares Means|Differences of Least Squares Means|0.9398|Standard Error of the Mean|0.2941||0.0053|2-Sided||||||Mixed Models Analysis|||Baseline to Followup|
1599625|NCT02833350|2939498|Superiority||Adjusted Difference|0.68||||0.9051|2-Sided|95.0|-10.58|11.95|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599626|NCT02833350|2939498|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599628|NCT02833350|2939498|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599629|NCT02833350|2939498|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599630|NCT02833350|2939498|Superiority||Adjusted Difference|5.45||||0.0501|2-Sided|95.0|0.0|10.91|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599631|NCT02833350|2939498|Superiority||Adjusted Difference|3.65||||0.127|2-Sided|95.0|-1.04|8.35|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599632|NCT02833350|2939498|Superiority||Adjusted Difference|-0.4||||0.8979|2-Sided|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599633|NCT02833350|2939498|Superiority||Adjusted Difference|3.64||||0.105|2-Sided|95.0|-0.76|8.03|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599634|NCT02833350|2939498|Superiority||Adjusted Difference|2.74||||0.1446|2-Sided|95.0|-0.94|6.42|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599635|NCT02833350|2939498|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599636|NCT02833350|2939498|Superiority||Mean Difference (Net)|0.91||||0.5976|2-Sided|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599637|NCT02833350|2939498|Superiority||Adjusted Difference|0.91||||0.5726|2-Sided|95.0|-2.26|4.09|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599638|NCT02833350|2939498|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599639|NCT02833350|2939498|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599640|NCT02833350|2939498|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599641|NCT02833350|2939498|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599642|NCT02833350|2939498|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599643|NCT02833350|2939498|Superiority||Adjusted Difference|0.91||||0.5976|2-Sided|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599644|NCT02833350|2939498|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599645|NCT02833350|2939499|Superiority||Adjusted Difference|-9.22|||<|0.0001|2-Sided|95.0|-13.63|-4.81|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599646|NCT02833350|2939499|Superiority||Adjusted Difference|-10.8|||<|0.0001|2-Sided|95.0|-15.33|-6.32|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599647|NCT02833350|2939499|Superiority||Adjusted Difference|-4.24|||<|0.0534|2-Sided|95.0|-8.53|0.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599648|NCT02833350|2939499|Superiority||Adjusted Difference|-2.08|||<|0.3374|2-Sided|95.0|-6.36|2.2|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599649|NCT02833350|2939499|Superiority||Adjusted Difference|-3.22|||<|0.0856|2-Sided|95.0|-6.91|0.46|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599650|NCT02833350|2939499|Superiority||Adjusted Difference|0.86|||<|0.9525|2-Sided|95.0|-2.88|4.6|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599651|NCT02833350|2939499|Superiority||Adjusted Difference|1.29|||<|0.8284|2-Sided|95.0|-2.46|5.03|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599652|NCT02833350|2939499|Superiority||Adjusted Difference|4.85|||<|0.0073|2-Sided|95.0|1.02|8.69|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599653|NCT02833350|2939499|Superiority||Adjusted Difference|4.55|||<|0.0138|2-Sided|95.0|0.71|8.39|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599654|NCT02833350|2939499|Superiority||Adjusted Difference|5.07|||<|0.0034|2-Sided|95.0|1.34|8.81|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599655|NCT02833350|2939499|Superiority||Adjusted Difference|4.67|||<|0.0088|2-Sided|95.0|0.91|8.42|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599656|NCT02833350|2939499|Superiority||Adjusted Difference|3.26|||<|0.0841|2-Sided|95.0|-0.3|6.82|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599657|NCT02833350|2939499|Superiority||Adjusted Difference|4.04|||<|0.0206|2-Sided|95.0|0.46|7.62|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599658|NCT02833350|2939499|Superiority||Adjusted Difference|3.98|||<|0.0129|2-Sided|95.0|0.64|7.32|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599659|NCT02833350|2939499|Superiority||Adjusted Difference|4.64|||<|0.0025|2-Sided|95.0|1.31|7.96|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599660|NCT02833350|2939499|Superiority||Adjusted Difference|-5.88|||<|0.0006|2-Sided|95.0|-9.65|-2.1|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599661|NCT02833350|2939499|Superiority||Adjusted Difference|-5.45|||<|0.0016|2-Sided|95.0|-9.23|-1.68|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599662|NCT02833350|2939499|Superiority||Adjusted Difference|-3.28|||<|0.3434|2-Sided|95.0|-8.43|1.87|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599663|NCT02833350|2939499|Superiority||Adjusted Difference|-3.18|||<|0.1451|2-Sided|95.0|-7.06|0.71|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599664|NCT02833350|2939499|Superiority||Adjusted Difference|-3.49|||<|0.095|2-Sided|95.0|-7.38|0.41|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599665|NCT02833350|2939499|Superiority||Adjusted Difference|-2.47|||<|0.6336|2-Sided|95.0|-7.84|2.9|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599666|NCT02833350|2939499|Superiority||Adjusted Difference|-5.27|||<|0.0026|2-Sided|95.0|-9.06|-1.48|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599667|NCT02833350|2939499|Superiority||Adjusted Difference|-5.67|||<|0.0011|2-Sided|95.0|-9.48|-1.87|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599668|NCT02833350|2939499|Superiority||Adjusted Difference|-3.98|||<|0.2018|2-Sided|95.0|-9.25|1.3|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599669|NCT02833350|2939499|Superiority||Adjusted Difference|-3.97|||<|0.0239|2-Sided|95.0|-7.54|-0.39|||Cochran-Mantel-Haenszel|||Week 2, Week 14|
1599670|NCT02833350|2939499|Superiority||Adjusted Difference|-3.18|||<|0.0998|2-Sided|95.0|-6.78|0.41|||Cochran-Mantel-Haenszel|||Week 2, Week 14|
1599671|NCT02833350|2939499|Superiority||Adjusted Difference|-0.94|||<|0.9761|2-Sided|95.0|-5.93|4.06|||Cochran-Mantel-Haenszel|||Week 2, Week 14|
1599672|NCT02833350|2939499|Superiority||Adjusted Difference|-2.62|||<|0.1739|2-Sided|95.0|-5.97|0.72|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599673|NCT02833350|2939499|Superiority||Adjusted Difference|-1.97|||<|0.4114|2-Sided|95.0|-5.3|1.36|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599674|NCT02833350|2939499|Superiority||Adjusted Difference|-2.36|||<|0.5455|2-Sided|95.0|-7.0|2.27|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599675|NCT02833350|2939500|Superiority||Adjusted Difference|0.68||||0.9009|2-Sided|95.0|-10.1|11.47|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599676|NCT02833350|2939500|Superiority||Adjusted Difference|4.11||||0.3838|2-Sided|95.0|-5.14|13.36|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599677|NCT02833350|2939500|Superiority||Adjusted Difference|2.05||||0.6564|2-Sided|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599678|NCT02833350|2939500|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599679|NCT02833350|2939500|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599680|NCT02833350|2939500|Superiority||Adjusted Difference|5.45||||0.0478|2-Sided|95.0|0.05|10.86|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599681|NCT02833350|2939500|Superiority||Adjusted Difference|4.57||||0.0708|2-Sided|95.0|-0.39|9.52|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599682|NCT02833350|2939500|Superiority||Adjusted Difference|-0.4||||0.8979|2-Sided|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599683|NCT02833350|2939500|Superiority||Adjusted Difference|5.45||||0.0286|2-Sided|95.0|0.57|10.34|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599684|NCT02833350|2939500|Superiority||Adjusted Difference|2.74||||0.1446|2-Sided|95.0|-0.94|6.42|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599685|NCT02833350|2939500|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599686|NCT02833350|2939500|Superiority||Adjusted Difference|0.91||||0.5976|2-Sided|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599687|NCT02833350|2939500|Superiority||Adjusted Difference|0.91||||0.5726|2-Sided|95.0|-2.26|4.09|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599688|NCT02833350|2939500|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599689|NCT02833350|2939500|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599690|NCT02833350|2939500|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599691|NCT02833350|2939500|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599692|NCT02833350|2939500|Superiority||Adjusted Difference|0.91||||0.5976|2-Sided|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599693|NCT02833350|2939500|Superiority||Adjusted Difference|0.91||||0.5976|2-Sided|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599694|NCT02833350|2939500|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599695|NCT02833350|2939501|Superiority||Adjusted Difference|-8.23||||0.0003|2-Sided|95.0|-12.56|-3.9|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599696|NCT02833350|2939501|Superiority||Adjusted Difference|-9.93|||<|0.0001|2-Sided|95.0|-14.31|-5.55|||Cochran-Mantel-Haenszel|||Week 8, Day 54|
1599697|NCT02833350|2939501|Superiority||Adjusted Difference|-4.2|||<|0.0476|2-Sided|95.0|-8.36|-0.04|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599698|NCT02833350|2939501|Superiority||Adjusted Difference|-2.12|||<|0.3202|2-Sided|95.0|-6.33|2.09|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599699|NCT02833350|2939501|Superiority||Adjusted Difference|-3.22|||<|0.0927|2-Sided|95.0|-6.98|0.54|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599700|NCT02833350|2939501|Superiority||Adjusted Difference|0.66|||<|0.9791|2-Sided|95.0|-2.97|4.3|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599701|NCT02833350|2939501|Superiority||Adjusted Difference|1.03|||<|0.9032|2-Sided|95.0|-2.59|4.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599702|NCT02833350|2939501|Superiority||Adjusted Difference|4.04|||<|0.0252|2-Sided|95.0|0.37|7.7|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599703|NCT02833350|2939501|Superiority||Adjusted Difference|3.85|||<|0.036|2-Sided|95.0|0.18|7.51|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599704|NCT02833350|2939501|Superiority||Adjusted Difference|4.18|||<|0.0161|2-Sided|95.0|0.59|7.78|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599705|NCT02833350|2939501|Superiority||Adjusted Difference|4.29|||<|0.0131|2-Sided|95.0|0.69|7.9|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599706|NCT02833350|2939501|Superiority||Adjusted Difference|2.33|||<|0.2851|2-Sided|95.0|-1.09|5.76|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599707|NCT02833350|2939501|Superiority||Adjusted Difference|3.27|||<|0.0698|2-Sided|95.0|-0.18|6.72|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599708|NCT02833350|2939501|Superiority||Adjusted Difference|2.31|||<|0.2309|2-Sided|95.0|-0.87|5.48|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599709|NCT02833350|2939501|Superiority||Adjusted Difference|3.21|||<|0.0455|2-Sided|95.0|0.05|6.37|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599710|NCT02833350|2939501|Superiority||Adjusted Difference|-5.47|||<|0.0011|2-Sided|95.0|-9.15|-1.78|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599711|NCT02833350|2939501|Superiority||Adjusted Difference|-5.1|||<|0.0027|2-Sided|95.0|-8.77|-1.42|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599712|NCT02833350|2939501|Superiority||Adjusted Difference|-2.94|||<|0.422|2-Sided|95.0|-7.96|2.09|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599713|NCT02833350|2939501|Superiority||Adjusted Difference|-2.94|||<|0.1675|2-Sided|95.0|-6.65|0.78|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599714|NCT02833350|2939501|Superiority||Adjusted Difference|-3.12|||<|0.1282|2-Sided|95.0|-6.84|0.59|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599715|NCT02833350|2939501|Superiority||Adjusted Difference|-2.29|||<|0.6503|2-Sided|95.0|-7.39|2.8|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599716|NCT02833350|2939501|Superiority||Adjusted Difference|-4.68|||<|0.0059|2-Sided|95.0|-8.3|-1.06|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599717|NCT02833350|2939501|Superiority||Adjusted Difference|-4.57|||<|0.0078|2-Sided|95.0|-8.2|-0.94|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599718|NCT02833350|2939501|Superiority||Adjusted Difference|-3.22|||<|0.3358|2-Sided|95.0|-8.24|1.8|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599719|NCT02833350|2939501|Superiority||Adjusted Difference|-4.07|||<|0.0138|2-Sided|95.0|-7.51|-0.63|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599720|NCT02833350|2939501|Superiority||Adjusted Difference|-3.14|||<|0.0893|2-Sided|95.0|-6.6|0.33|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599721|NCT02833350|2939501|Superiority||Adjusted Difference|-1.25|||<|0.9237|2-Sided|95.0|-6.02|3.52|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599722|NCT02833350|2939501|Superiority||Adjusted Difference|-3.08|||<|0.0608|2-Sided|95.0|-6.26|0.1|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599723|NCT02833350|2939501|Superiority||Adjusted Difference|-2.18|||<|0.2736|2-Sided|95.0|-5.34|0.98|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599724|NCT02833350|2939501|Superiority||Adjusted Difference|-2.36|||<|0.496|2-Sided|95.0|-6.73|2.02|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599725|NCT02833350|2939502|Superiority||Adjusted Difference|6.57||||0.2457|2-Sided|95.0|-4.52|17.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599726|NCT02833350|2939502|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-8.77|8.77|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599727|NCT02833350|2939502|Superiority||Adjusted Difference|2.03||||0.6658|2-Sided|95.0|-7.17|11.22|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599728|NCT02833350|2939502|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-8.39|8.39|||Cochran-Mantel-Haenszel|||Week 2 Day 14|
1599729|NCT02833350|2939502|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-8.68|8.68|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599730|NCT02833350|2939502|Superiority||Adjusted Difference|3.2||||0.2425|2-Sided|95.0|-2.16|8.55|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599731|NCT02833350|2939502|Superiority||Adjusted Difference|0.74||||0.7101|2-Sided|95.0|-3.17|4.66|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599732|NCT02833350|2939502|Superiority||Adjusted Difference|-0.46||||0.8787|2-Sided|95.0|-6.34|5.42|||Cochran-Mantel-Haenszel|||Week 12 Day 84|
1599733|NCT02833350|2939502|Superiority||Adjusted Difference|0.97||||0.6656|2-Sided|95.0|-3.42|5.35|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599734|NCT02833350|2939502|Superiority||Adjusted Difference|0.87||||0.6876|2-Sided|95.0|-3.36|5.09|||Cochran-Mantel-Haenszel|||Week 8 Day 56|
1599735|NCT02833350|2939502|Superiority||Adjusted Difference|-0.46||||0.8788|2-Sided|95.0|-6.31|5.4|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599736|NCT02833350|2939502|Superiority||Adjusted Difference|-0.94||||0.5927|2-Sided|95.0|-4.4|2.51|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599737|NCT02833350|2939502|Superiority||Adjusted Difference|-0.13||||0.9424|2-Sided|95.0|-3.78|3.51|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599738|NCT02833350|2939502|Superiority||Adjusted Difference|-0.43||||0.8929|2-Sided|95.0|-6.62|5.77|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599739|NCT02833350|2939502|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599740|NCT02833350|2939502|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-2.95|2.95|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599741|NCT02833350|2939502|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-6.17|6.17|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599742|NCT02833350|2939502|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-2.93|2.93|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599743|NCT02833350|2939502|Superiority||Adjusted Difference|0.93||||0.5941|2-Sided|95.0|-2.5|4.37|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599744|NCT02833350|2939502|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-6.28|6.28|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599745|NCT02833350|2939503|Superiority||Adjusted Difference|1.37||||0.7848|2-Sided|95.0|-8.46|11.2|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599746|NCT02833350|2939503|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599747|NCT02833350|2939503|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599748|NCT02833350|2939503|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-8.31|8.31|||Cochran-Mantel-Haenszel|||Week 2 Day 14|
1599749|NCT02833350|2939503|Superiority||Adjusted Difference|2.05||||0.6588|2-Sided|95.0|-7.07|11.18|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599750|NCT02833350|2939503|Superiority||Adjusted Difference|4.55||||0.1749|2-Sided|95.0|-2.02|11.11|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599751|NCT02833350|2939503|Superiority||Adjusted Difference|3.7||||0.2635|2-Sided|95.0|-2.79|10.19|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599752|NCT02833350|2939503|Superiority||Adjusted Difference|-1.6||||0.7134|2-Sided|95.0|-10.14|6.94|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599753|NCT02833350|2939503|Superiority||Adjusted Difference|2.73||||0.3021|2-Sided|95.0|-2.45|7.91|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599754|NCT02833350|2939503|Superiority||Adjusted Difference|1.83||||0.4473|2-Sided|95.0|-2.9|6.56|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599755|NCT02833350|2939503|Superiority||Adjusted Difference|-1.6||||0.6309|2-Sided|95.0|-8.13|4.93|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599756|NCT02833350|2939503|Superiority||Adjusted Difference|0.91||||0.6669|2-Sided|95.0|-3.23|5.05|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599757|NCT02833350|2939503|Superiority||Adjusted Difference|-0.91||||0.5976|2-Sided|95.0|-4.3|2.48|||Cochran-Mantel-Haenszel|||Week 4 Day 28|
1599758|NCT02833350|2939503|Superiority||Adjusted Difference|-0.4||||0.8979|2-Sided|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599759|NCT02833350|2939503|Superiority||Adjusted Difference|0.91||||0.5976|2-Sided|95.0|-2.47|4.28|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599760|NCT02833350|2939503|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599761|NCT02833350|2939503|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599762|NCT02833350|2939503|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-2.91|2.91|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599763|NCT02833350|2939503|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-2.92|2.92|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599764|NCT02833350|2939503|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599765|NCT02833350|2939504|Superiority||Adjusted Difference|11.64||||0.0584|2-Sided|95.0|-0.41|23.7|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599766|NCT02833350|2939504|Superiority||Adjusted Difference|0.68||||0.8853|2-Sided|95.0|-8.62|9.99|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599767|NCT02833350|2939504|Superiority||Adjusted Difference|2.05||||0.6564|2-Sided|95.0|-7.0|11.11|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599768|NCT02833350|2939504|Superiority||Adjusted Difference|0.68||||0.8853|2-Sided|95.0|-8.62|9.99|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599769|NCT02833350|2939504|Superiority||Adjusted Difference|2.05||||0.6588|2-Sided|95.0|-7.07|11.18|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599770|NCT02833350|2939504|Superiority||Adjusted Difference|10.91||||0.0044|2-Sided|95.0|3.39|18.43|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599771|NCT02833350|2939504|Superiority||Mean Difference (Net)|15.62||||0.0003|2-Sided|95.0|7.22|24.03|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599772|NCT02833350|2939504|Superiority||Adjusted Difference|3.2||||0.549|2-Sided|95.0|-7.27|13.67|||Cochran-Mantel-Haenszel|||Week 12, Day 84|
1599773|NCT02833350|2939504|Superiority||Adjusted Difference|8.18||||0.0234|2-Sided|95.0|1.11|15.26|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599774|NCT02833350|2939504|Superiority||Adjusted Difference|4.61||||0.1655|2-Sided|95.0|-1.9|11.12|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599775|NCT02833350|2939504|Superiority||Adjusted Difference|-2.4||||0.4765|2-Sided|95.0|-9.01|4.21|||Cochran-Mantel-Haenszel|||Week 8, Day 56|
1599776|NCT02833350|2939504|Superiority||Adjusted Difference|4.55||||0.1185|2-Sided|95.0|-1.16|10.25|||Cochran-Mantel-Haenszel|||Week 4, Day 28|
1599777|NCT02833350|2939504|Superiority||Adjusted Difference|0.01||||0.9975|2-Sided|95.0|-4.35|4.36|||Cochran-Mantel-Haenszel|||Week 4 Day 28|
1599778|NCT02833350|2939504|Superiority||Adjusted Difference|-0.8||||0.7988|2-Sided|95.0|-6.95|5.35|||Cochran-Mantel-Haenszel|||Week 4 Day 28|
1599779|NCT02833350|2939504|Superiority||Adjusted Difference|0.91||||0.6546|2-Sided|95.0|-3.07|4.89|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599780|NCT02833350|2939504|Superiority||Adjusted Difference|-0.91||||0.5976|2-Sided|95.0|-4.3|2.48|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599781|NCT02833350|2939504|Superiority||Adjusted Difference|-0.4||||0.8979|2-Sided|95.0|-6.51|5.71|||Cochran-Mantel-Haenszel|||Week 2, Day 14|
1599782|NCT02833350|2939504|Superiority||Adjusted Difference|1.82||||0.3482|2-Sided|95.0|-1.98|5.62|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599783|NCT02833350|2939504|Superiority||Adjusted Difference|0.91||||0.5976|2-Sided|95.0|-2.48|4.3|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599784|NCT02833350|2939504|Superiority||Adjusted Difference|0.0||||1|2-Sided|95.0|-6.06|6.06|||Cochran-Mantel-Haenszel|||Week 1, Day 7|
1599785|NCT02833350|2939505|Superiority||Adjusted Difference|-0.82||||0.0002|2-Sided|95.0|-1.24|-0.4|||ANCOVA|||Week 12, Day 84|
1599786|NCT02833350|2939505|Superiority||Adjusted Difference|-0.78||||0.0003|2-Sided|95.0|-1.19|-0.37|||ANCOVA|||Week 8. Day 56|
1599787|NCT02833350|2939505|Superiority||Adjusted Difference|-0.44||||0.0213|2-Sided|95.0|-0.81|-0.07|||ANCOVA|||Week 4, Day 28|
1599788|NCT02833350|2939505|Superiority||Adjusted Difference|-0.23||||0.1867|2-Sided|95.0|-0.56|0.11|||ANCOVA|||Week 2, Day 14|
1599789|NCT02833350|2939505|Superiority||Adjusted Difference|-0.29||||0.0463|2-Sided|95.0|-0.57|0.0|||ANCOVA|||Week 1, Day 7|
1599790|NCT02833350|2939505|Superiority||Adjusted Difference|0.06||||0.9891|2-Sided|95.0|-0.34|0.46|||ANCOVA|||Week 12, Day 84|
1599791|NCT02833350|2939505|Superiority||Adjusted Difference|0.06||||0.9881|2-Sided|95.0|-0.34|0.46|||ANCOVA|||Week 12, Day 84|
1599792|NCT02833350|2939505|Superiority||Adjusted Difference|0.42||||0.0259|2-Sided|95.0|0.04|0.8|||ANCOVA|||Week 8, Day 56|
1599793|NCT02833350|2939505|Superiority||Adjusted Difference|0.39||||0.045|2-Sided|95.0|0.01|0.77|||ANCOVA|||Week 8, Day 56|
1599794|NCT02833350|2939505|Superiority||Adjusted Difference|0.53||||0.0007|2-Sided|95.0|0.19|0.88|||ANCOVA|||Week 4, Day 28|
1599795|NCT02833350|2939505|Superiority||Adjusted Difference|0.53||||0.0007|2-Sided|95.0|0.18|0.88|||ANCOVA|||Week 4, Day 28|
1599796|NCT02833350|2939505|Superiority||Adjusted Difference|0.4||||0.0039|2-Sided|95.0|0.1|0.7|||ANCOVA|||Week 2, Day 14|
1599797|NCT02833350|2939505|Superiority||Adjusted Difference|0.39||||0.006|2-Sided|95.0|0.09|0.69|||ANCOVA|||Week 2, Day 14|
1599798|NCT02833350|2939505|Superiority||Adjusted Difference|0.42||||0.0003|2-Sided|95.0|0.16|0.68|||ANCOVA|||Week 1, Day 7|
1599799|NCT02833350|2939505|Superiority||Adjusted Difference|0.41||||0.0005|2-Sided|95.0|0.15|0.67|||ANCOVA|||Week 1, Day 7|
1599800|NCT02833350|2939505|Superiority||Adjusted Difference|-0.62||||0.0008|2-Sided|95.0|-1.03|-0.21|||ANCOVA|||Week 12, Day 84|
1599801|NCT02833350|2939505|Superiority||Adjusted Difference|-0.62||||0.0009|2-Sided|95.0|-1.03|-0.21|||ANCOVA|||Week 12, Day 84|
1599802|NCT02833350|2939505|Superiority||Adjusted Difference|-0.43||||0.1853|2-Sided|95.0|-0.99|0.13|||ANCOVA|||Week 12, Day 84|
1599803|NCT02833350|2939505|Superiority||Adjusted Difference|-0.36||||0.0753|2-Sided|95.0|-0.75|0.03|||ANCOVA|||Week 8, Day 56|
1599804|NCT02833350|2939505|Superiority||Adjusted Difference|-0.39||||0.0472|2-Sided|95.0|-0.78|0.0|||ANCOVA|||Week 8, Day 56|
1599805|NCT02833350|2939505|Superiority||Adjusted Difference|-0.28||||0.4981|2-Sided|95.0|-0.81|0.24|||ANCOVA|||Week 8, Day 56|
1599806|NCT02833350|2939505|Superiority||Adjusted Difference|-0.38||||0.0274|2-Sided|95.0|-0.73|-0.03|||ANCOVA|||Week 4, Day 28|
1599807|NCT02833350|2939505|Superiority||Adjusted Difference|-0.38||||0.0286|2-Sided|95.0|-0.73|-0.03|||ANCOVA|||Week 4, Day 28|
1599808|NCT02833350|2939505|Superiority||Adjusted Difference|-0.33||||0.2762|2-Sided|95.0|-0.82|0.15|||ANCOVA|||Week 4, Day 28|
1599809|NCT02833350|2939505|Superiority||Adjusted Difference|-0.27||||0.1021|2-Sided|95.0|-0.57|0.04|||ANCOVA|||Week 2, Day 14|
1623040|NCT02289729|2979652|Superiority||||||<|0.0001|||||||t-test||||
1599810|NCT02833350|2939505|Superiority||Adjusted Difference|-0.28||||0.0856|2-Sided|95.0|-0.58|0.03|||ANCOVA|||Week 2, Day 14|
1599811|NCT02833350|2939505|Superiority||Adjusted Difference|-0.14||||0.8495|2-Sided|95.0|-0.55|0.28|||ANCOVA|||Week 2, Day 14|
1599812|NCT02833350|2939505|Superiority||Adjusted Difference|-0.17||||0.3158|2-Sided|95.0|-0.43|0.09|||ANCOVA|||Week 1, Day 7|
1599813|NCT02833350|2939505|Superiority||Adjusted Difference|-0.18||||0.2672|2-Sided|95.0|-0.44|0.08|||ANCOVA|||Week 1, Day 7|
1599814|NCT02833350|2939505|Superiority||Adjusted Difference|-0.17||||0.6083|2-Sided|95.0|-0.53|0.19|||ANCOVA|||Week 1, Day 7|
1599815|NCT02833350|2939506|Superiority||Adjusted Difference|-0.73||||0.0003|2-Sided|95.0|-1.11|-0.34|||ANCOVA|||Week 12, Day 84|
1599816|NCT02833350|2939506|Superiority||Adjusted Difference|-0.68||||0.0004|2-Sided|95.0|-1.04|-0.31|||ANCOVA|||Week 8, Day 56|
1599817|NCT02833350|2939506|Superiority||Adjusted Difference|-0.35||||0.0346|2-Sided|95.0|-0.68|-0.03|||ANCOVA|||Week 4, Day 28|
1599818|NCT02833350|2939506|Superiority||Adjusted Difference|-0.13||||0.3936|2-Sided|95.0|-0.43|0.17|||ANCOVA|||Week 2, Day 14|
1599819|NCT02833350|2939506|Superiority||Adjusted Difference|-0.19||||0.1496|2-Sided|95.0|-0.45|0.07|||ANCOVA|||Week 1, Day 7|
1599820|NCT02833350|2939506|Superiority||Adjusted Difference|0.09||||0.952|2-Sided|95.0|-0.29|0.46|||ANCOVA|||Week 12, Day 84|
1599821|NCT02833350|2939506|Superiority||Adjusted Difference|0.09||||0.9338|2-Sided|95.0|-0.28|0.47|||ANCOVA|||Week 12, Day 84|
1599822|NCT02833350|2939506|Superiority||Adjusted Difference|0.37||||0.0365|2-Sided|95.0|0.02|0.72|||ANCOVA|||Week 8, Day 56|
1599823|NCT02833350|2939506|Superiority||Adjusted Difference|0.34||||0.065|2-Sided|95.0|-0.01|0.69|||ANCOVA|||Week 8, Day 56|
1599824|NCT02833350|2939506|Superiority||Adjusted Difference|0.52||||0.0002|2-Sided|95.0|0.21|0.84|||ANCOVA|||Week 4, Day 28|
1599825|NCT02833350|2939506|Superiority||Adjusted Difference|0.5||||0.0004|2-Sided|95.0|0.19|0.82|||ANCOVA|||Week 4, Day 28|
1599826|NCT02833350|2939506|Superiority||Adjusted Difference|0.35||||0.0056|2-Sided|95.0|0.08|0.63|||ANCOVA|||Week 2, Day 14|
1599827|NCT02833350|2939506|Superiority||Adjusted Difference|0.35||||0.0082|2-Sided|95.0|0.07|0.62|||ANCOVA|||Week 2, Day 14|
1599828|NCT02833350|2939506|Superiority||Adjusted Difference|0.33||||0.002|2-Sided|95.0|0.1|0.57|||ANCOVA|||Week 1, Day 7|
1599829|NCT02833350|2939506|Superiority||Adjusted Difference|0.31||||0.005|2-Sided|95.0|0.07|0.55|||ANCOVA|||Week 1, Day 7|
1599830|NCT02833350|2939506|Superiority||Adjusted Difference|-0.54||||0.0016|2-Sided|95.0|-0.92|-0.17|||ANCOVA|||Week 12, Day 84|
1599831|NCT02833350|2939506|Superiority||Adjusted Difference|-0.54||||0.002|2-Sided|95.0|-0.91|-0.16|||ANCOVA|||Week 12, Day 84|
1599832|NCT02833350|2939506|Superiority||Adjusted Difference|-0.35||||0.2873|2-Sided|95.0|-0.86|0.17|||ANCOVA|||Week 12, Day 84|
1599833|NCT02833350|2939506|Superiority||Adjusted Difference|-0.29||||0.1391|2-Sided|95.0|-0.65|0.06|||ANCOVA|||Week 8, Day 56|
1599834|NCT02833350|2939506|Superiority||Adjusted Difference|-0.32||||0.092|2-Sided|95.0|-0.68|0.04|||ANCOVA|||Week 8, Day 56|
1599835|NCT02833350|2939506|Superiority||Adjusted Difference|-0.25||||0.5566|2-Sided|95.0|-0.74|-0.24|||ANCOVA|||Week 8, Day 56|
1599836|NCT02833350|2939506|Superiority||Adjusted Difference|-0.24||||0.189|2-Sided|95.0|-0.56|0.07|||ANCOVA|||Week 4, Day 28|
1599837|NCT02833350|2939506|Superiority||Adjusted Difference|-0.26||||0.1441|2-Sided|95.0|-0.58|0.06|||ANCOVA|||Week 4, Day 28|
1599838|NCT02833350|2939506|Superiority||Adjusted Difference|-0.24||||0.4915|2-Sided|95.0|-0.68|0.2|||ANCOVA|||Week 4, Day 28|
1599839|NCT02833350|2939506|Superiority||Adjusted Difference|-0.16||||0.4328|2-Sided|95.0|-0.43|0.12|||ANCOVA|||Week 2, Day 14|
1599840|NCT02833350|2939506|Superiority||Adjusted Difference|-0.17||||0.3862|2-Sided|95.0|-0.44|0.11|||ANCOVA|||Week 2, Day 14|
1599841|NCT02833350|2939506|Superiority||Adjusted Difference|-0.13||||0.8095|2-Sided|95.0|-0.51|0.24|||ANCOVA|||Week 2, Day 14|
1599842|NCT02833350|2939506|Superiority||Adjusted Difference|-0.08||||0.8542|2-Sided|95.0|-0.31|0.16|||ANCOVA|||Week 1, Day 7|
1599843|NCT02833350|2939506|Superiority||Adjusted Difference|-0.1||||0.7062|2-Sided|95.0|-0.33|0.14|||ANCOVA|||Week 1, Day 7|
1599844|NCT02833350|2939506|Superiority||Adjusted Difference|-0.09||||0.9193|2-Sided|95.0|-0.41|0.24|||ANCOVA|||Week 1, Day 7|
1599845|NCT02833350|2939507|Superiority||Adjusted Difference|-0.83||||0.0001|2-Sided|95.0|-1.24|-0.42|||ANCOVA|||Week 12, Day 84|
1599846|NCT02833350|2939507|Superiority||Adjusted Difference|-0.84|||<|0.0001|2-Sided|95.0|-1.22|-0.46|||ANCOVA|||Week 8, Day 56|
1599847|NCT02833350|2939507|Superiority||Adjusted Difference|-0.38|||<|0.0479|2-Sided|95.0|-0.76|0.0|||ANCOVA|||Week 4, Day 28|
1599848|NCT02833350|2939507|Superiority||Adjusted Difference|-0.28|||<|0.0974|2-Sided|95.0|-0.62|0.05|||ANCOVA|||Week 2, Day 14|
1599849|NCT02833350|2939507|Superiority||Adjusted Difference|-0.22|||<|0.1368|2-Sided|95.0|-0.52|0.07|||ANCOVA|||Week 1, Day 7|
1599850|NCT02833350|2939507|Superiority||Adjusted Difference|0.16|||<|0.7158|2-Sided|95.0|-0.22|0.53|||ANCOVA|||Week 12, Day 84|
1599851|NCT02833350|2939507|Superiority||Adjusted Difference|0.15|||<|0.7565|2-Sided|95.0|-0.23|0.52|||ANCOVA|||Week 12, Day 84|
1599852|NCT02833350|2939507|Superiority||Adjusted Difference|0.44|||<|0.0124|2-Sided|95.0|0.07|0.8|||ANCOVA|||Week 8, Day 56|
1599853|NCT02833350|2939507|Superiority||Adjusted Difference|0.46|||<|0.0084|2-Sided|95.0|0.09|0.82|||ANCOVA|||Week 8, Day 56|
1599854|NCT02833350|2939507|Superiority||Adjusted Difference|0.54|||<|0.0002|2-Sided|95.0|0.21|0.87|||ANCOVA|||Week 4, Day 28|
1599855|NCT02833350|2939507|Superiority||Adjusted Difference|0.58|||<|0.0001|2-Sided|95.0|0.25|0.91|||ANCOVA|||Week 4, Day 28|
1599856|NCT02833350|2939507|Superiority||Adjusted Difference|0.43|||<|0.0012|2-Sided|95.0|0.14|0.72|||ANCOVA|||Week 2, Day 14|
1599857|NCT02833350|2939507|Superiority||Adjusted Difference|0.5|||<|0.0001|2-Sided|95.0|0.21|0.79|||ANCOVA|||Week 2, Day 14|
1599858|NCT02833350|2939507|Superiority||Adjusted Difference|0.61|||<|0.0001|2-Sided|95.0|0.34|0.88|||ANCOVA|||Week 1, Day 7|
1602234|NCT02756689|2943614|Superiority|||||||0.06|||||||Wilcoxon (Mann-Whitney)||||
1599859|NCT02833350|2939507|Superiority||Adjusted Difference|0.64|||<|0.0001|2-Sided|95.0|0.37|0.9|||ANCOVA|||Week 1, Day 7|
1599860|NCT02833350|2939507|Superiority||Adjusted Difference|-0.62|||<|0.0003|2-Sided|95.0|-1.0|-0.24|||ANCOVA|||Week 12, Day 84|
1599861|NCT02833350|2939507|Superiority||Adjusted Difference|-0.63|||<|0.0002|2-Sided|95.0|-1.01|-0.25|||ANCOVA|||Week 12, Day 84|
1599862|NCT02833350|2939507|Superiority||Adjusted Difference|-0.41|||<|0.1696|2-Sided|95.0|-0.93|0.11|||ANCOVA|||Week 12, Day 84|
1599863|NCT02833350|2939507|Superiority||Adjusted Difference|-0.39|||<|0.0365|2-Sided|95.0|-0.76|-0.02|||ANCOVA|||Week 8, Day 56|
1599864|NCT02833350|2939507|Superiority||Adjusted Difference|-0.37|||<|0.0526|2-Sided|95.0|-0.74|0.0|||ANCOVA|||Week 8, Day 56|
1599865|NCT02833350|2939507|Superiority||Adjusted Difference|-0.31|||<|0.3943|2-Sided|95.0|-0.82|0.2|||ANCOVA|||Week 8, Day 56|
1599866|NCT02833350|2939507|Superiority||Adjusted Difference|-0.44|||<|0.0046|2-Sided|95.0|-0.77|-0.11|||ANCOVA|||Week 4, Day 28|
1599867|NCT02833350|2939507|Superiority||Adjusted Difference|-0.4|||<|0.0119|2-Sided|95.0|-0.74|-0.07|||ANCOVA|||Week 4, Day 28|
1599868|NCT02833350|2939507|Superiority||Adjusted Difference|-0.39|||<|0.1338|2-Sided|95.0|-0.85|0.08|||ANCOVA|||Week 4, Day 28|
1599869|NCT02833350|2939507|Superiority||Adjusted Difference|-0.28|||<|0.0586|2-Sided|95.0|-0.58|0.01|||ANCOVA|||Week 2, Day 14|
1599870|NCT02833350|2939507|Superiority||Adjusted Difference|-0.21|||<|0.2244|2-Sided|95.0|-0.51|0.08|||ANCOVA|||Week 2, Day 14|
1599871|NCT02833350|2939507|Superiority||Adjusted Difference|-0.06|||<|0.9891|2-Sided|95.0|-0.47|0.35|||ANCOVA|||Week 2, Day 14|
1599872|NCT02833350|2939507|Superiority||Adjusted Difference|-0.15|||<|0.4475|2-Sided|95.0|-0.42|0.12|||ANCOVA|||Week 1, Day 7|
1599873|NCT02833350|2939507|Superiority||Adjusted Difference|-0.12|||<|0.627|2-Sided|95.0|-0.39|0.14|||ANCOVA|||Week 1, Day 7|
1599874|NCT02833350|2939507|Superiority||Adjusted Difference|-0.18|||<|0.5807|2-Sided|95.0|-0.55|0.19|||ANCOVA|||Week 1, Day 7|
1599875|NCT02833350|2939508|Superiority||Adjusted Difference|-0.76||||0.0002|2-Sided|95.0|-1.15|-0.38|||ANCOVA|||Week 12, Day 84|
1599876|NCT02833350|2939508|Superiority||Adjusted Difference|-0.77|||<|0.0001|2-Sided|95.0|-1.11|-0.42|||ANCOVA|||Week 8, Day 56|
1599877|NCT02833350|2939508|Superiority||Adjusted Difference|-0.31|||<|0.0667|2-Sided|95.0|-0.65|0.02|||ANCOVA|||Week 4, Day 28|
1599878|NCT02833350|2939508|Superiority||Adjusted Difference|-0.2|||<|0.1831|2-Sided|95.0|-0.5|0.1|||ANCOVA|||Week 2, Day 14|
1599879|NCT02833350|2939508|Superiority||Adjusted Difference|-0.11|||<|0.4286|2-Sided|95.0|-0.38|0.16|||ANCOVA|||Week 1, Day 7|
1599880|NCT02833350|2939508|Superiority||Adjusted Difference|0.19|||<|0.5035|2-Sided|95.0|-0.16|0.53|||ANCOVA|||Week 12, Day 84|
1599881|NCT02833350|2939508|Superiority||Adjusted Difference|0.19|||<|0.4839|2-Sided|95.0|-0.16|0.54|||ANCOVA|||Week 12, Day 84|
1599882|NCT02833350|2939508|Superiority||Adjusted Difference|0.4|||<|0.0153|2-Sided|95.0|0.06|0.74|||ANCOVA|||Week 8, Day 56|
1599883|NCT02833350|2939508|Superiority||Adjusted Difference|0.42|||<|0.0095|2-Sided|95.0|0.08|0.76|||ANCOVA|||Week 8, Day 56|
1599884|NCT02833350|2939508|Superiority||Adjusted Difference|0.55|||<|0.0001|2-Sided|95.0|0.24|0.85|||ANCOVA|||Week 4, Day 28|
1599885|NCT02833350|2939508|Superiority||Adjusted Difference|0.56|||<|0.0001|2-Sided|95.0|0.25|0.87|||ANCOVA|||Week 4, Day 28|
1599886|NCT02833350|2939508|Superiority||Adjusted Difference|0.4|||<|0.0009|2-Sided|95.0|0.13|0.66|||ANCOVA|||Week 2, Day 14|
1599887|NCT02833350|2939508|Superiority||Adjusted Difference|0.47|||<|0.0001|2-Sided|95.0|0.2|0.74|||ANCOVA|||Week 2, Day 14|
1599888|NCT02833350|2939508|Superiority||Mean Difference (Net)|0.55|||<|0.0001|2-Sided|95.0|0.31|0.8|||ANCOVA|||Week 1, Day 7|
1599889|NCT02833350|2939508|Superiority||Adjusted Difference|0.58|||<|0.0001|2-Sided|95.0|0.34|0.82|||ANCOVA|||Week 1, Day 7|
1599890|NCT02833350|2939508|Superiority||Adjusted Difference|-0.57|||<|0.0003|2-Sided|95.0|-0.92|-0.22|||ANCOVA|||Week 12, Day 84|
1599891|NCT02833350|2939508|Superiority||Adjusted Difference|-0.57|||<|0.0003|2-Sided|95.0|-0.92|-0.22|||ANCOVA|||Week 12, Day 84|
1599892|NCT02833350|2939508|Superiority||Adjusted Difference|-0.36|||<|0.2079|2-Sided|95.0|-0.84|0.12|||ANCOVA|||Week 12, Day 84|
1599893|NCT02833350|2939508|Superiority||Adjusted Difference|-0.33|||<|0.0612|2-Sided|95.0|-0.68|0.01|||ANCOVA|||Week 8, Day 56|
1599894|NCT02833350|2939508|Superiority||Adjusted Difference|-0.31|||<|0.0969|2-Sided|95.0|-0.66|0.04|||ANCOVA|||Week 8, Day 56|
1599895|NCT02833350|2939508|Superiority||Adjusted Difference|-0.28|||<|0.4271|2-Sided|95.0|-0.76|0.2|||ANCOVA|||Week 8, Day 56|
1599896|NCT02833350|2939508|Superiority||Adjusted Difference|-0.31|||<|0.044|2-Sided|95.0|-0.62|-0.01|||ANCOVA|||Week 4, Day 28|
1599897|NCT02833350|2939508|Superiority||Adjusted Difference|-0.3|||<|0.0598|2-Sided|95.0|-0.61|0.01|||ANCOVA|||Week 4, Day 28|
1599898|NCT02833350|2939508|Superiority||Adjusted Difference|-0.29|||<|0.2885|2-Sided|95.0|-0.72|0.14|||ANCOVA|||Week 4, Day 28|
1599899|NCT02833350|2939508|Superiority||Adjusted Difference|-0.18|||<|0.2634|2-Sided|95.0|-0.45|0.08|||ANCOVA|||Week 2, Day 14|
1599900|NCT02833350|2939508|Superiority||Adjusted Difference|-0.12|||<|0.6826|2-Sided|95.0|-0.38|0.15|||ANCOVA|||Week 2, Day 14|
1599901|NCT02833350|2939508|Superiority||Adjusted Difference|-0.06|||<|0.9853|2-Sided|95.0|-0.43|0.31|||ANCOVA|||Week 2, Day 14|
1599902|NCT02833350|2939508|Superiority||Adjusted Difference|-0.06|||<|0.923|2-Sided|95.0|-0.31|0.18|||ANCOVA|||Week 1 Day 7|
1599903|NCT02833350|2939508|Superiority||Adjusted Difference|-0.04|||<|0.9884|2-Sided|95.0|-0.28|0.21|||ANCOVA|||At week 1, Day 7|
1599904|NCT02833350|2939508|Superiority||adjusted difference|-0.11|||<|0.8504|2-Sided|95.0|-0.45|0.23|||ANCOVA|||Week 1, Day 7|
1599905|NCT02833350|2939512|Superiority||Weighted difference|13.7||||0.0717|2-Sided|95.0|-1.21|28.61|||Cochran-Mantel-Haenszel||||
1599906|NCT02833350|2939513|Superiority||Weighted difference|-1.5||||0.8132||95.0|-13.96|10.95|||Cochran-Mantel-Haenszel||||
1599907|NCT02833350|2939513|Superiority||Weighted difference|-8.58||||0.1694|2-Sided|95.0|-20.82|3.66|||Cochran-Mantel-Haenszel||||
1602235|NCT02756689|2943615|Superiority|||||||0.12|||||||Wilcoxon (Mann-Whitney)||||
1599908|NCT02833350|2939515|Superiority||Weighted difference|20.0||||0.0003|2-Sided|95.0|9.21|30.79|||Cochran-Mantel-Haenszel||||
1599909|NCT02833350|2939515|Superiority||Weighted difference|12.93||||0.0164|2-Sided|95.0|2.37|23.48|||Cochran-Mantel-Haenszel||||
1599910|NCT02833350|2939515|Superiority||Weighted difference|8.0||||0.2503|2-Sided|95.0|-5.64|21.64|||Cochran-Mantel-Haenszel||||
1599911|NCT02832674|2939516|Other|||||||0.025|||||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.
1599912|NCT02832674|2939517|Other|||||||0.025|||||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.
1599913|NCT02832674|2939518|Other|||||||0.025|||||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.
1599914|NCT02832674|2939519|Other|||||||0.025|||||||Chi-squared|||Analysis of all effectiveness endpoints was conducted on the ITT population and on the PP population.|The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.
1599915|NCT02832674|2939520|Other|Binomial test of proportions||||||0.025|||||||Chi-squared||||The summary included number and percentage of subjects in each of the categories and the 2 sided Clopper-Pearson 95% CI. a binomial test of proportions tested the improvement at Day 90 and Day 180.
1599916|NCT02832674|2939521|Superiority|||||||0.05|||||||Fisher Exact|||The primary endpoint was an evaluation of the proportion of subjects with ≥ 20 mm2 lift at Day 90.|
1599917|NCT02832375|2939524|Superiority or Other||Least Square (LS) mean difference|-0.45|||<|0.0001|2-Sided|95.0|-0.577|-0.319|||ANCOVA|From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|H0= no difference between experimental dentifrice and control dentifrice H1= a difference between experimental dentifrice and control dentifrice|
1599918|NCT02831855|2939532|Superiority||Difference in percentage of participants|-6.62|Standard Error of the Mean|3.89|||2-Sided|95.0|-14.26|1.0||||||Week 48|
1599919|NCT02831855|2939532|Superiority||Difference in percentage of participants|-10.02|Standard Error of the Mean|3.87|||2-Sided|95.0|-17.61|-2.42||||||Week 36|
1599920|NCT02831855|2939533|Superiority||LS Mean Difference|0.18|Standard Error of the Mean|0.64|||2-Sided|95.0|-1.07|1.44||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline FACIT - fatigue scale score as a covariate.|
1599921|NCT02831855|2939533|Superiority||LS Mean Difference|-0.19|Standard Error of the Mean|0.6|||2-Sided|95.0|-1.37|1.0||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline FACIT - fatigue scale score as a covariate.|
1599922|NCT02831855|2939534|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.06|0.01||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline EQ-5D score as a covariate.|
1599923|NCT02831855|2939534|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.07|-0.01||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline EQ-5D score as a covariate.|
1599924|NCT02831855|2939535|Superiority||LS Mean Difference|-2.46|Standard Error of the Mean|4.19|||2-Sided|95.0|-10.72|5.8||||||Change at Week 48: Work productivity loss- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI work productivity loss score as a covariate.|
1599925|NCT02831855|2939535|Superiority||LS Mean Difference|2.84|Standard Error of the Mean|3.45|||2-Sided|95.0|-3.97|9.65||||||Change at Week 36: Work productivity loss- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI work productivity loss score as a covariate.|
1599926|NCT02831855|2939535|Superiority||LS Mean Difference|-0.9|Standard Error of the Mean|3.77|||2-Sided|95.0|-8.34|6.54||||||Change at Week 48: Presenteeism- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI presenteeism score as a covariate.|
1599927|NCT02831855|2939535|Superiority||LS Mean Difference|3.01|Standard Error of the Mean|2.97|||2-Sided|95.0|-2.84|8.87||||||Change at Week 36: Presenteeism- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI presenteeism score as a covariate.|
1599928|NCT02831855|2939535|Superiority||LS Mean Difference|1.6|Standard Error of the Mean|2.04|||2-Sided|95.0|-2.41|5.61||||||Change at Week 48: Daily activity impairment- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI daily activity impairment score as a covariate.|
1599929|NCT02831855|2939535|Superiority||LS Mean Difference|3.19|Standard Error of the Mean|1.88|||2-Sided|95.0|-0.51|6.89||||||Change at Week 36: Daily activity impairment- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI daily activity impairment score as a covariate.|
1599930|NCT02831855|2939535|Superiority||LS Mean Difference|-0.51|Standard Error of the Mean|2.28|||2-Sided|95.0|-5.01|3.99||||||Change at Week 48: Absenteeism Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI absenteeism score as a covariate.|
1599931|NCT02831855|2939535|Superiority||LS Mean Difference|1.61|Standard Error of the Mean|2.41|||2-Sided|95.0|-3.14|6.37||||||Change at Week 36: Absenteeism Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline WPAI absenteeism score as a covariate.|
1600053|NCT02831764|2939570|Other||Mean Difference (Net)|-0.2||||0.797|2-Sided|95.0|-1.4|1.1|||MMRM||Week 24. Serum RBP||
1599932|NCT02831855|2939536|Superiority||LS Mean Difference|-0.68|Standard Error of the Mean|0.7|||2-Sided|95.0|-2.06|0.7||||||Change at Week 48: Mental Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental component score as a covariate.|
1599933|NCT02831855|2939536|Superiority||LS Mean Difference|-0.82|Standard Error of the Mean|0.67|||2-Sided|95.0|-2.13|0.49||||||Change at Week 36: Mental Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental component score as a covariate.|
1599934|NCT02831855|2939536|Superiority||LS Mean Difference|0.09|Standard Error of the Mean|0.61|||2-Sided|95.0|-1.11|1.29||||||Change at Week 48: Physical Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a biological disease-modifying anti-rheumatic drug (DMARD), and baseline SF-36 physical component score- as a covariate.|
1599935|NCT02831855|2939536|Superiority||LS Mean Difference|-0.82|Standard Error of the Mean|0.61|||2-Sided|95.0|-2.01|0.37||||||Change at Week 36: Physical Component Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score- as a covariate.|
1599936|NCT02831855|2939537|Superiority||LS Mean Difference|0.62|Standard Error of the Mean|0.62|||2-Sided|95.0|-0.6|1.83||||||Change at Week 48: General Health Perception Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 general health perception score as a covariate.|
1599937|NCT02831855|2939537|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.61|||2-Sided|95.0|-1.3|1.08||||||Change at Week 36: General Health Perception Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 general health perception score as a covariate.|
1599938|NCT02831855|2939537|Superiority||LS Mean Difference|-0.52|Standard Error of the Mean|0.73|||2-Sided|95.0|-1.94|0.91||||||Change at Week 48: Vitality Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 vitality score as a covariate.|
1599939|NCT02831855|2939537|Superiority||LS Mean Difference|-1.15|Standard Error of the Mean|0.7|||2-Sided|95.0|-2.52|0.22||||||Change at Week 36: Vitality Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 vitality score as a covariate.|
1599940|NCT02831855|2939537|Superiority||LS Mean Difference|-0.47|Standard Error of the Mean|0.75|||2-Sided|95.0|-1.95|1.01||||||Change at Week 48: Role Emotional Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role emotional score as a covariate.|
1599941|NCT02831855|2939537|Superiority||LS Mean Difference|-1.11|Standard Error of the Mean|0.78|||2-Sided|95.0|-2.64|0.43||||||Change at Week 36: Role Emotional Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role emotional score as a covariate.|
1599942|NCT02831855|2939537|Superiority||LS Mean Difference|-0.46|Standard Error of the Mean|0.75|||2-Sided|95.0|-1.94|1.02||||||Change at Week 48: Mental Health Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental health score as a covariate.|
1599943|NCT02831855|2939537|Superiority||LS Mean Difference|-0.9|Standard Error of the Mean|0.71|||2-Sided|95.0|-2.29|0.49||||||Change at Week 36: Mental Health Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 mental health score as a covariate.|
1599944|NCT02831855|2939537|Superiority||LS Mean Difference|-0.75|Standard Error of the Mean|0.75|||2-Sided|95.0|-2.23|0.73||||||Change at Week 48: Bodily Pain Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 bodily pain score as a covariate.|
1599945|NCT02831855|2939537|Superiority||LS Mean Difference|-1.45|Standard Error of the Mean|0.74|||2-Sided|95.0|-2.9|-0.01||||||Change at Week 36: Bodily Pain Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 bodily pain score as a covariate.|
1599946|NCT02831855|2939537|Superiority||LS Mean Difference|-0.51|Standard Error of the Mean|0.73|||2-Sided|95.0|-1.95|0.93||||||Change at Week 48: Social functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 Social functioning score as a covariate.|
1599947|NCT02831855|2939537|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.69|||2-Sided|95.0|-1.5|1.21||||||Change at Week 36: Social functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 Social functioning score as a covariate.|
1599948|NCT02831855|2939537|Superiority||LS Mean Difference|-0.73|Standard Error of the Mean|0.66|||2-Sided|95.0|-2.13|0.66||||||Change at Week 48: Role Physical Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role physical score score as a covariate.|
1599949|NCT02831855|2939537|Superiority||LS Mean Difference|-1.67|Standard Error of the Mean|0.66|||2-Sided|95.0|-2.97|-0.37||||||Change at Week 36: Role Physical Score- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 role physical score score as a covariate.|
1599950|NCT02831855|2939537|Superiority||LS Mean Difference|0.52|Standard Error of the Mean|0.68|||2-Sided|95.0|-0.82|1.85||||||Change at Week 48: Physical Functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score as a covariate.|
1599951|NCT02831855|2939537|Superiority||LS Mean Difference|-0.44|Standard Error of the Mean|0.69|||2-Sided|95.0|-1.79|0.92||||||Change at Week 36: Physical Functioning- Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD, and baseline SF-36 physical component score as a covariate.|
1600050|NCT02831764|2939569|Other||Mean Difference (Net)|1.7|||<|0.056|2-Sided|95.0|0.0|3.5|||MMRM||Week 48. GFR Cystatin C adjusted.||
1599952|NCT02831855|2939538|Superiority||LS Mean Difference|0.02|Standard Error of the Mean|0.04|||2-Sided|95.0|-0.06|0.09||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline HAQ-DI.|
1599953|NCT02831855|2939538|Superiority||LS Mean Difference|0.09|Standard Error of the Mean|0.04|||2-Sided|95.0|0.02|0.16||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline HAQ-DI.|
1599954|NCT02831855|2939539|Superiority||Difference in percentage of participants|-4.97|||||2-Sided|95.0|-13.32|3.36||||||Week 48|
1599955|NCT02831855|2939539|Superiority||Difference in percentage of participants|-5.37|||||2-Sided|95.0|-13.63|2.89||||||Week 36|
1599956|NCT02831855|2939540|Superiority||Difference in percentage of participants|-11.99|||||2-Sided|95.0|-20.22|-3.75||||||Week 48|
1599957|NCT02831855|2939540|Superiority||Difference in percentage of participants|-12.75|||||2-Sided|95.0|-21.01|-4.48||||||Week 36|
1599958|NCT02831855|2939541|Superiority||Difference in percentage of participants|-6.59|||||2-Sided|95.0|-13.8|0.61||||||Week 48|
1599959|NCT02831855|2939541|Superiority||Difference in percentage of participants|-6.96|||||2-Sided|95.0|-14.06|0.14||||||Week 36|
1599960|NCT02831855|2939542|Superiority||Difference in percentage of participants|-3.16|||||2-Sided|95.0|-10.99|4.65||||||Week 48|
1599961|NCT02831855|2939542|Superiority||Difference in percentage of participants|-8.85|||||2-Sided|95.0|-16.38|-1.31||||||Week 36|
1599962|NCT02831855|2939543|Superiority||Difference in percentage of participants|-2.41|||||2-Sided|95.0|-10.18|5.35||||||Week 48|
1599963|NCT02831855|2939543|Superiority||Difference in percentage of participants|-8.84|||||2-Sided|95.0|-16.44|-1.24||||||Week 36|
1599964|NCT02831855|2939544|Superiority||Difference in percentage of participants|-4.13|||||2-Sided|95.0|-12.62|4.36||||||Week 48|
1599965|NCT02831855|2939544|Superiority||Difference in percentage of participants|-5.63|||||2-Sided|95.0|-14.12|2.84||||||Week 36|
1599966|NCT02831855|2939545|Superiority||Difference in percentage of participants|-6.21|||||2-Sided|95.0|-13.74|1.32||||||Week 48|
1599967|NCT02831855|2939545|Superiority||Difference in percentage of participants|-8.11|||||2-Sided|95.0|-15.4|-0.82||||||Week 36|
1599968|NCT02831855|2939546|Superiority||Difference in percentage of participants|-1.33|||||2-Sided|95.0|-8.5|5.83||||||Week 48|
1599969|NCT02831855|2939546|Superiority||Difference in percentage of participants|-8.52|||||2-Sided|95.0|-15.27|-1.78||||||Week 36|
1599970|NCT02831855|2939547|Superiority||Difference in percentage of participants|-10.02|||||2-Sided|95.0|-17.68|-2.37||||||Week 48|
1599971|NCT02831855|2939547|Superiority||Difference in percentage of participants|-7.02|||||2-Sided|95.0|-14.81|0.77||||||Week 36|
1599972|NCT02831855|2939548|Superiority||Difference in percentage of participants|-11.91|||||2-Sided|95.0|-19.56|-4.26||||||Week 48|
1599973|NCT02831855|2939548|Superiority||Difference in percentage of participants|-7.39|||||2-Sided|95.0|-15.17|0.38||||||Week 36|
1599974|NCT02831855|2939549|Superiority||Difference in percentage of participants|-8.52|||||2-Sided|95.0|-16.28|-0.76||||||Week 48|
1599975|NCT02831855|2939549|Superiority||Difference in percentage of participants|-5.14|||||2-Sided|95.0|-13.07|2.77||||||Week 36|
1599976|NCT02831855|2939550|Superiority||Difference in percentage of participants|-4.54|||||2-Sided|95.0|-13.04|3.94||||||Week 48|
1599977|NCT02831855|2939550|Superiority||Difference in percentage of participants|-5.69|||||2-Sided|95.0|-14.15|2.76||||||Week 36|
1599978|NCT02831855|2939551|Superiority||LS Mean Difference|2.23|Standard Error of the Mean|0.69|||2-Sided|95.0|0.86|3.59||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline SDAI value as a covariate.|
1599979|NCT02831855|2939551|Superiority||LS Mean Difference|1.95|Standard Error of the Mean|0.72|||2-Sided|95.0|0.53|3.37||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline SDAI value as a covariate.|
1599980|NCT02831855|2939552|Superiority||LS Mean Difference|2.13|Standard Error of the Mean|0.66|||2-Sided|95.0|0.83|3.43||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline CDAI value as a covariate.|
1599981|NCT02831855|2939552|Superiority||LS Mean Difference|1.74|Standard Error of the Mean|0.68|||2-Sided|95.0|0.4|3.07||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline CDAI value as a covariate.|
1599982|NCT02831855|2939553|Superiority||LS Mean Difference|0.28|Standard Error of the Mean|0.09|||2-Sided|95.0|0.11|0.45||||||Change at Week 48: Linear MMRM was used that included the fixed effects of treatment, visit, treatment -by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (CRP) value as a covariate.|
1599983|NCT02831855|2939553|Superiority||LS Mean Difference|0.26|Standard Error of the Mean|0.09|||2-Sided|95.0|0.08|0.43||||||Change at Week 36: Linear MMRM was used that included the fixed effects of treatment, visit, treatment -by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (CRP) value as a covariate.|
1599984|NCT02831855|2939554|Superiority||LS Mean Difference|0.22|Standard Error of the Mean|0.1|||2-Sided|95.0|0.03|0.41||||||Linear MMRM was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a bDMARD and baseline DAS28-4 (ESR) value as a covariate.|
1599985|NCT02831855|2939555|Non-Inferiority|Non-inferiority (NI) of Tofacitinib 11 mg + Methotrexate Placebo to Tofacitinib 11 mg + continued Methotrexate was concluded if the upper bound of 95% 2-sided confidence interval (CI) for difference between the 2 arms (Tofacitinib 11 mg + Methotrexate Placebo reporting arm - Tofacitinib 11 mg + continued Methotrexate arm) was lower than 0.6.|Least Square (LS) Mean Difference|0.3|Standard Error of the Mean|0.09||0.0005|2-Sided|95.0|0.12|0.48||The p-value is one-sided for the test against the NI margin of 0.6.|MMRM|||Linear mixed-effect model of repeated measures (MMRM) was used that included the fixed effects of treatment, visit, treatment-by-visit interaction, prior use of a biological disease-modifying anti-rheumatic drug (bDMARD), and baseline DAS28-4 (ESR) value as a covariate.|
1600051|NCT02831764|2939569|Other||Mean Difference (Net)|3.6|||<|0.001|2-Sided|95.0|1.8|5.4|||MMRM||Week 24. GFR Cystatin C adjusted.||
1599986|NCT02831764|2939556|Other||Mean Difference (Net)|-0.6||||0.328|2-Sided|95.0|-1.9|0.6|||MMRM||Week 48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, and Baseline EQ-5D utility, treatment*visit and Baseline EQ-5D utility*visit as factors and covariate, with visit as the repeated factor.||
1599987|NCT02831764|2939556|Other||Mean Difference (Net)|-0.6||||0.358|2-Sided|95.0|-1.9|0.7|||MMRM||Week 24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment*visit and Baseline EQ-5D utility*visit as factors and covariate, with visit as the repeated factor.||
1599988|NCT02831764|2939556|Other||Mean Difference (Net)|-1.3||||0.045|2-Sided|95.0|-2.6|0.0|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count and Baseline EQ-5D utility, treatment*visit and Baseline EQ-5D utility*visit as factors and covariate, with visit as the repeated factor.||
1599989|NCT02831764|2939557|Other||Mean Difference (Net)|-0.0019||||0.703|2-Sided|95.0|-0.0117|0.0079|||MMRM||Week 48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment*visit and Baseline EQ-5D utility*visit as factors and covariate, with visit as the repeated factor.||
1599990|NCT02831764|2939557|Other||Mean Difference (Net)|0.0003||||0.943|2-Sided|95.0|-0.0088|0.0095|||MMRM||Week 24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment*visit and Baseline EQ-5D utility*visit as factors and covariate, with visit as the repeated factor.||
1599991|NCT02831764|2939557|Other||Mean Difference (Net)|-0.0019||||0.759|2-Sided|95.0|-0.0137|0.01|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA , Baseline CD4+ cell count , and Baseline EQ-5D utility, treatment*visit and Baseline EQ-5D utility*visit as factors and covariate, with visit as the repeated factor.||
1599992|NCT02831764|2939558|Other||Mean Difference (Net)|59.19|||||2-Sided|95.0|-19.73|138.11|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.||
1599993|NCT02831764|2939558|Other||Mean Difference (Net)|12.93|||||2-Sided|95.0|-71.9|97.75|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.||
1599994|NCT02831764|2939558|Other||Mean Difference (Net)|68.74|||||2-Sided|95.0|-1.24|138.72|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.||
1599995|NCT02831764|2939558|Other||Mean Difference (Net)|13.9|||||2-Sided|95.0|-16.35|44.15|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.||
1599996|NCT02831764|2939558|Other||Mean Difference (Net)|19.23|||||2-Sided|95.0|-7.65|46.1|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.||
1599997|NCT02831764|2939558|Other||Mean Difference (Net)|59.66|||||2-Sided|95.0|-8.62|127.94|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.||
1599998|NCT02831764|2939558|Other||Mean Difference (Net)|65.53|||||2-Sided|95.0|-14.43|145.5|||||Age Group,>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.||
1599999|NCT02831764|2939558|Other||Mean Difference (Net)|-9.9|||||2-Sided|95.0|-53.1|33.3|||||Age Group,35 to <50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.||
1600000|NCT02831764|2939558|Other||Mean Difference (Net)|38.99|||||2-Sided|95.0|5.88|72.09|||||Age Group,<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.||
1600001|NCT02831764|2939558|Other||Mean Difference (Net)|22.57|||||2-Sided|95.0|-3.42|48.55|||||Baseline CD4+ cell count,>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.||
1600002|NCT02831764|2939558|Other||Mean Difference (Net)|61.72|||||2-Sided|95.0|-26.94|150.39|||||Baseline CD4+ cell count,<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.||
1600003|NCT02831764|2939558|Other||Mean Difference (Net)|-26.81|||||2-Sided|95.0|-82.72|29.1|||||Baseline plasma HIV-1 RNA,>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.||
1600004|NCT02831764|2939558|Other||Mean Difference (Net)|37.8|||||2-Sided|95.0|9.98|65.62|||||Baseline plasma HIV-1 RNA,<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.||
1600005|NCT02831764|2939559|Other||Mean Difference (Net)|35.0|||||2-Sided|95.0|-49.0|119.0|||||Race group-Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.||
1600006|NCT02831764|2939559|Other||Mean Difference (Net)|15.7|||||2-Sided|95.0|-74.4|105.9|||||Race group-Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.||
1600007|NCT02831764|2939559|Other||Mean Difference (Net)|-19.8|||||2-Sided|95.0|-97.1|57.6|||||Race group-African Am/African H. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.||
1600008|NCT02831764|2939559|Other||Mean Difference (Net)|9.1|||||2-Sided|95.0|-22.9|41.1|||||Race group-white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race, and treatment and race interaction.||
1600009|NCT02831764|2939559|Other||Mean Difference (Net)|12.8|||||2-Sided|95.0|-15.7|41.2|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.||
1600052|NCT02831764|2939570|Other||Mean Difference (Net)|0.7||||0.258|2-Sided|95.0|-0.5|1.9|||MMRM||Week 48. Serum RBP||
1600010|NCT02831764|2939559|Other||Mean Difference (Net)|-27.3|||||2-Sided|95.0|-100.8|46.1|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.||
1600011|NCT02831764|2939559|Other||Mean Difference (Net)|5.2|||||2-Sided|95.0|-81.4|91.8|||||Age Group-1,>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.||
1600012|NCT02831764|2939559|Other||Mean Difference (Net)|-31.5|||||2-Sided|95.0|-77.1|14.2|||||Age Group-1,35 to <50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.||
1600013|NCT02831764|2939559|Other||Mean Difference (Net)|32.5|||||2-Sided|95.0|-2.7|67.7|||||Age Group-1,<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.||
1600014|NCT02831764|2939559|Other||Mean Difference (Net)|4.1|||||2-Sided|95.0|-23.5|31.7|||||Baseline CD4+ cell count,>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.||
1600015|NCT02831764|2939559|Other||Mean Difference (Net)|57.7|||||2-Sided|95.0|-37.2|152.5|||||Baseline CD4+ cell count,<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.||
1600016|NCT02831764|2939559|Other||Mean Difference (Net)|13.2|||||2-Sided|95.0|-46.8|73.2|||||Baseline plasma HIV-1 RNA,>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and Baseline plasma HIV-1 RNA interaction.||
1600017|NCT02831764|2939559|Other||Mean Difference (Net)|6.9|||||2-Sided|95.0|-22.7|36.6|||||Baseline plasma HIV-1 RNA,<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, Baseline plasma HIV-1 RNA, and treatment and relevant Baseline plasma HIV-1 RNA interaction.||
1600018|NCT02831764|2939562|Other||Mean Difference (Final Values)|2.8||||0.037|2-Sided|95.0|0.2|5.4|||Fisher Exact||Week 48||
1600019|NCT02831764|2939562|Other||Mean Difference (Final Values)|3.5|||<|0.001|2-Sided|95.0|1.5|5.6|||Fisher Exact||Week 24||
1600020|NCT02831764|2939565|Other||Mean Difference (Net)|-0.1||||0.96|2-Sided|95.0|-2.8|2.6|||MMRM||Week 48||
1600021|NCT02831764|2939565|Other||Mean Difference (Net)|-4.2||||0.015|2-Sided|95.0|-7.5|-0.8|||MMRM||Week 24||
1600022|NCT02831764|2939566|Other||Mean Difference (Net)|-0.2043|||<|0.001|2-Sided|95.0|-0.2532|-0.1554|||MMRM||Week 48, CTX-1||
1600023|NCT02831764|2939566|Other||Mean Difference (Net)|-0.127|||<|0.001|2-Sided|95.0|-0.164|-0.09|||MMRM||Week 24, CTX-1||
1600024|NCT02831764|2939566|Other||Mean Difference (Net)|-12.8|||<|0.001|2-Sided|95.0|-15.4|-10.2|||MMRM||Week 48, Serum PINP||
1600025|NCT02831764|2939566|Other||Mean Difference (Net)|-13.5|||<|0.001|2-Sided|95.0|-16.4|-10.6|||MMRM||Week 24, Serum PINP||
1600026|NCT02831764|2939566|Other||Mean Difference (Net)|-5.9|||<|0.001|2-Sided|95.0|-6.89|-4.91|||MMRM||Week 48, Serum Osteocalcin||
1600027|NCT02831764|2939566|Other||Mean Difference (Net)|-4.67|||<|0.001|2-Sided|95.0|-5.63|-3.71|||MMRM||Week 28, Serum Osteocalcin||
1600028|NCT02831764|2939566|Other||Mean Difference (Net)|-3.09|||<|0.001|2-Sided|95.0|-3.75|-2.44|||MMRM||Week 48, Bone ALP||
1600029|NCT02831764|2939566|Other||Mean Difference (Net)|-2.66|||<|0.001|2-Sided|95.0|-3.25|-2.08|||MMRM||Week 24, Bone ALP||
1600030|NCT02831764|2939567|Other||Ratio of geometric means|0.888||||0.052|2-Sided|95.0|0.787|1.001|||MMRM||Week 48. Urine RBP/Urine Creatinine||
1600031|NCT02831764|2939567|Other||Ratio of geometric means|0.826||||0.003|2-Sided|95.0|0.728|0.936|||MMRM||Week 24. Urine RBP/Urine Creatinine||
1600032|NCT02831764|2939567|Other||Ratio of geometric means|0.903||||0.2|2-Sided|95.0|0.773|1.056|||MMRM||Week 48. Urine RBP 4||
1600033|NCT02831764|2939567|Other||Ratio of geometric means|0.796||||0.003|2-Sided|95.0|0.683|0.927|||MMRM||Week 24. Urine RBP 4||
1600034|NCT02831764|2939567|Other||Ratio of geometric means|0.86|||<|0.001|2-Sided|95.0|0.795|0.93|||MMRM||Week 48. Urine Protein/Creatinine.||
1600035|NCT02831764|2939567|Other||Ratio of geometric means|0.826|||<|0.001|2-Sided|95.0|0.769|0.887|||MMRM||Week 24. Urine Protein/Creatinine.||
1600036|NCT02831764|2939567|Other||Ratio of geometric means|1.062|||<|0.311|2-Sided|95.0|0.945|1.194|||MMRM||Week 48. Urine Phosphate.||
1600037|NCT02831764|2939567|Other||Ratio of geometric means|0.979|||<|0.728|2-Sided|95.0|0.868|1.104|||MMRM||Week 24. Urine Phosphate.||
1600038|NCT02831764|2939567|Other||Ratio of geometric means|0.742|||<|0.012|2-Sided|95.0|0.588|0.935|||MMRM||Week 48. Urine B2M/Urine Creatinine.||
1600039|NCT02831764|2939567|Other||Ratio of geometric means|0.781|||<|0.007|2-Sided|95.0|0.654|0.934|||MMRM||Week 24. Urine B2M/Urine Creatinine.||
1600040|NCT02831764|2939567|Other||Ratio of geometric means|0.938|||<|0.308|2-Sided|95.0|0.83|1.061|||MMRM||Week 48. Urine Albumin/Creatinine.||
1600041|NCT02831764|2939567|Other||Ratio of geometric means|0.889|||<|0.036|2-Sided|95.0|0.796|0.992|||MMRM||Week 24. Urine Albumin/Creatinine.||
1600042|NCT02831764|2939567|Other||Ratio of geometric means|0.693|||<|0.005|2-Sided|95.0|0.538|0.892|||MMRM||Week 48. Urine B2M.||
1600043|NCT02831764|2939567|Other||Ratio of geometric means|0.748|||<|0.002|2-Sided|95.0|0.621|0.901|||MMRM||Week 24. Urine B2M.||
1600044|NCT02831764|2939567|Other||Ratio of geometric means|0.914|||<|0.001|2-Sided|95.0|0.89|0.939|||MMRM||Week 48. Serum B2M.||
1600045|NCT02831764|2939567|Other||Ratio of geometric means|0.917|||<|0.001|2-Sided|95.0|0.893|0.941|||MMRM||Week 24. Serum B2M.||
1600046|NCT02831764|2939568|Other||Mean Difference (Net)|-3.12|||<|0.001|2-Sided|95.0|-4.59|-1.65|||MMRM||Week 48. Serum Plasma creatinine||
1600047|NCT02831764|2939568|Other||Mean Difference (Net)|-3.02|||<|0.001|2-Sided|95.0|-4.49|-1.55|||MMRM||Week 24. Serum Plasma Creatinine||
1600048|NCT02831764|2939569|Other||Mean Difference (Net)|3.3|||<|0.001|2-Sided|95.0|1.6|5.0|||MMRM||Week 48. GFR creatinine adjusted.||
1600049|NCT02831764|2939569|Other||Mean Difference (Net)|3.4|||<|0.001|2-Sided|95.0|1.7|5.2|||MMRM||Week 24. GFR creatinine adjusted.||
1600054|NCT02831764|2939570|Other||Mean Difference (Net)|-0.02||||0.022|2-Sided|95.0|-0.03|0.0|||MMRM||Week 48. Serum Cystatin C.||
1600055|NCT02831764|2939570|Other||Mean Difference (Net)|-0.03|||<|0.001|2-Sided|95.0|-0.05|-0.02|||MMRM||Week 24. Serum Cystatin C.||
1600056|NCT02831764|2939580|Other||Mean Difference (Net)|8.5||||0.523|2-Sided|95.0|-17.7|34.8|||MMRM||Week 48. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.||
1600057|NCT02831764|2939580|Other||Mean Difference (Net)|25.6||||0.043|2-Sided|95.0|0.8|50.4|||Mixed Model Repeated Measures (MMRM)||Week 24. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.||
1600058|NCT02831764|2939582|Other||Hazard Ratio (HR)|1.02||||0.825|2-Sided|95.0|0.88|1.18||The generalised Wilcoxon procedure was used to estimate a p-value for detecting a difference in cumulative incidence curves between treatment groups.|Generalised Wilcoxon procedure||Hazard ratios were estimated using the Cox proportional hazard regression model.||
1600059|NCT02831764|2939583|Non-Inferiority|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 was greater than -10%.|Adjusted difference in proportion|0.1|||||2-Sided|95.0|-3.4|3.6|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (<= vs. >100,000 c/mL) and CD4+ cell count (<= vs. >200 cells/mm^3).||
1600060|NCT02831764|2939584|Non-Inferiority|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 was greater than -10%.|Adjusted difference in proportion|-0.7|||||2-Sided|95.0|-4.3|2.9|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (<= vs. >100,000 copies per milliliter) and CD4+ cell count (<= vs. >200 cells per cubic millimeter [cells/mm^3]).||
1600061|NCT02831673|2939585|Other||Mean Difference (Net)|1.5||||0.031|2-Sided|95.0|0.1|2.8|||MMRM||Week48. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment*visit and Baseline EQ-5D thermometer*visit with visit as the repeated factor||
1600062|NCT02831673|2939585|Other||Mean Difference (Net)|0.6||||0.458|2-Sided|95.0|-0.9|2.0|||MMRM||Week24. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment*visit and Baseline EQ-5D thermometer*visit with visit as the repeated factor||
1600063|NCT02831673|2939585|Other||Mean Difference (Net)|1.1||||0.137|2-Sided|95.0|-0.3|2.4|||MMRM||Week 4. Covariates adjusted: Treatment, Baseline plasma HIV-1 RNA (factor),Baseline CD4+ cell count (factor), Baseline EQ-5D thermometer, treatment*visit and Baseline EQ-5D thermometer*visit with visit as the repeated factor||
1600064|NCT02831673|2939586|Other||Mean Difference (Net)|0.0004||||0.934|2-Sided|95.0|-0.0098|0.0106|||MMRM||Week48. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment*visit and Baseline EQ-5D utility*visit with visit as the repeated factor||
1600065|NCT02831673|2939586|Other||Mean Difference (Net)|-0.0038||||0.45|2-Sided|95.0|-0.0136|0.006|||MMRM||Week24. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment*visit and Baseline EQ-5D utility*visit with visit as the repeated factor||
1600066|NCT02831673|2939586|Other||Mean Difference (Net)|0.0052||||0.302|2-Sided|95.0|-0.0047|0.0152|||MMRM||Week 4. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), and Baseline EQ-5D utility, treatment*visit and Baseline EQ-5D utility*visit with visit as the repeated factor||
1600067|NCT02831673|2939587|Other||Mean Difference (Net)|15.16|||||2-Sided|95.0|-13.9|44.21|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.||
1600068|NCT02831673|2939587|Other||Mean Difference (Net)|17.67|||||2-Sided|95.0|-49.89|85.23|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.||
1600069|NCT02831673|2939587|Other||Mean Difference (Net)|29.45|||||2-Sided|95.0|-55.47|114.38|||||Age>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.||
1600070|NCT02831673|2939587|Other||Mean Difference (Net)|-7.82|||||2-Sided|95.0|-55.98|40.34|||||Age 35 to <50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.||
1600071|NCT02831673|2939587|Other||Mean Difference (Net)|25.14|||||2-Sided|95.0|-9.56|59.85|||||Age<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.||
1600072|NCT02831673|2939587|Other||Mean Difference (Net)|14.37|||||2-Sided|95.0|-13.38|42.12|||||Baseline CD4+ cell count,>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.||
1600073|NCT02831673|2939587|Other||Mean Difference (Net)|36.84|||||2-Sided|95.0|-55.94|129.63|||||Baseline CD4+ cell count,<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.||
1600074|NCT02831673|2939587|Other||Mean Difference (Net)|0.67|||||2-Sided|95.0|-57.07|58.4|||||Baseline plasma HIV-1 RNA,>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.||
1600075|NCT02831673|2939587|Other||Mean Difference (Net)|19.8|||||2-Sided|95.0|-10.23|49.83|||||Baseline plasma HIV-1 RNA,<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and HIV-1 RNA interaction.||
1600109|NCT02831673|2939596|Other||Ratio of geometric means|0.695|||<|0.001|2-Sided|95.0|0.576|0.839|||Mixed Model Repeated Measures||Week 48. Urine B2M/Urine Creatinine||
1600076|NCT02831673|2939588|Other||Mean Difference (Net)|-8.1|||||2-Sided|95.0|-104.1|87.9|||||Race group Other. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.||
1600077|NCT02831673|2939588|Other||Mean Difference (Net)|49.2|||||2-Sided|95.0|-36.3|134.7|||||Race group Asian. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.||
1600078|NCT02831673|2939588|Other||Mean Difference (Net)|-23.0|||||2-Sided|95.0|-112.6|66.6|||||Race group African Am/African H.. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.||
1600079|NCT02831673|2939588|Other||Mean Difference (Net)|6.1|||||2-Sided|95.0|-28.5|40.7|||||Race group white. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, race group, and treatment and race group interaction.||
1600080|NCT02831673|2939588|Other||Mean Difference (Net)|5.6|||||2-Sided|95.0|-25.6|36.9|||||Male. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.||
1600081|NCT02831673|2939588|Other||Mean Difference (Net)|10.4|||||2-Sided|95.0|-62.3|83.1|||||Female. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, gender, and treatment and gender interaction.||
1600082|NCT02831673|2939588|Other||Mean Difference (Net)|17.7|||||2-Sided|95.0|-74.6|110.1|||||Age>=50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.||
1600083|NCT02831673|2939588|Other||Mean Difference (Net)|-2.5|||||2-Sided|95.0|-53.9|48.9|||||Age 35 to <50. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.||
1600084|NCT02831673|2939588|Other||Mean Difference (Net)|8.4|||||2-Sided|95.0|-29.1|45.9|||||Age<35. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, age, and treatment and age interaction.||
1600085|NCT02831673|2939588|Other||Mean Difference (Net)|5.2|||||2-Sided|95.0|-24.7|35.1|||||Baseline CD4+ cell count,>200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.||
1600086|NCT02831673|2939588|Other||Mean Difference (Net)|22.6|||||2-Sided|95.0|-78.3|123.5|||||Baseline CD4+ cell count,<=200. Following covariates were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, and treatment and Baseline CD4+ cell count interaction.||
1600087|NCT02831673|2939588|Other||Mean Difference (Net)|3.0|||||2-Sided|95.0|-59.8|65.9|||||Baseline plasma HIV-1 RNA,>100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count and treatment and HIV-1 RNA interaction.||
1600088|NCT02831673|2939588|Other||Mean Difference (Net)|7.6|||||2-Sided|95.0|-24.6|39.8|||||Baseline plasma HIV-1 RNA,<=100000. Following covariates/factors were adjusted: Treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count and treatment and HIV-1 RNA interaction.||
1600089|NCT02831673|2939591|Other||Difference in percentage|1.3||||0.414|2-Sided|95.0|-1.7|4.2||Fisher's exact p-value.|Fisher Exact||Week 48||
1600090|NCT02831673|2939591|Other||Difference in percentage|2.0||||0.157|2-Sided|95.0|-0.6|4.6||Fisher's exact p-value.|Fisher Exact||Week 24||
1600091|NCT02831673|2939594|Other||Mean Difference (Net)|-6.2|||<|0.001|2-Sided|95.0|-9.0|-3.4|||Mixed Model Repeated Measures||Week 48||
1600092|NCT02831673|2939594|Other||Mean Difference (Net)|-6.5|||<|0.001|2-Sided|95.0|-9.9|-3.0|||Mixed Model Repeated Measures||Week 24||
1600093|NCT02831673|2939595|Other||Mean Difference (Net)|-0.2015|||<|0.001|2-Sided|95.0|-0.246|-0.1569|||Mixed Model Repeated Measures||Week 48. CTX-1||
1600094|NCT02831673|2939595|Other||Mean Difference (Net)|-0.1628|||<|0.001|2-Sided|95.0|-0.2015|-0.1241|||Mixed Model Repeated Measures||Week 24. CTX-1||
1600095|NCT02831673|2939595|Other||Mean Difference (Net)|-12.6|||<|0.001|2-Sided|95.0|-15.0|-10.3|||Mixed Model Repeated Measures||Week 48. Serum PINP||
1600096|NCT02831673|2939595|Other||Mean Difference (Net)|-13.8|||<|0.001|2-Sided|95.0|-16.5|-11.1|||Mixed Model Repeated Measures||Week 24. Serum PINP||
1600097|NCT02831673|2939595|Other||Mean Difference (Net)|-5.23|||<|0.001|2-Sided|95.0|-6.22|-4.23|||Mixed Model Repeated Measures||Week 48. Serum Osteocalcin||
1600098|NCT02831673|2939595|Other||Mean Difference (Net)|-4.19|||<|0.001|2-Sided|95.0|-5.15|-3.23|||Mixed Model Repeated Measures||Week 28. Serum Osteocalcin||
1600099|NCT02831673|2939595|Other||Mean Difference (Net)|-2.58|||<|0.001|2-Sided|95.0|-3.19|-1.98|||Mixed Model Repeated Measures||Week 48. Bone ALP||
1600100|NCT02831673|2939595|Other||Mean Difference (Net)|-2.23|||<|0.001|2-Sided|95.0|-2.75|-1.7|||Mixed Model Repeated Measures||Week 24. Bone ALP||
1600101|NCT02831673|2939596|Other||Ratio of geometric means|0.765|||<|0.001|2-Sided|95.0|0.677|0.864|||Mixed Model Repeated Measures||Week 48. Urine RBP 4/Urine Creatinine||
1600102|NCT02831673|2939596|Other||Ratio of geometric means|0.828|||<|0.005|2-Sided|95.0|0.727|0.944|||Mixed Model Repeated Measures||Week 24. Urine RBP 4/Urine Creatinine||
1600103|NCT02831673|2939596|Other||Ratio of geometric means|0.748|||<|0.001|2-Sided|95.0|0.644|0.87|||Mixed Model Repeated Measures||Week 48. Urine RBP 4||
1600104|NCT02831673|2939596|Other||Ratio of geometric means|0.871|||<|0.087|2-Sided|95.0|0.743|1.02|||Mixed Model Repeated Measures||Week 24. Urine RBP 4||
1600105|NCT02831673|2939596|Other||Ratio of geometric means|0.829|||<|0.001|2-Sided|95.0|0.773|0.888|||Mixed Model Repeated Measures||Week 48. Urine Protein/Creatinine||
1600106|NCT02831673|2939596|Other||Ratio of geometric means|0.836|||<|0.001|2-Sided|95.0|0.774|0.904|||Mixed Model Repeated Measures||Week 24. Urine Protein/Creatinine||
1600107|NCT02831673|2939596|Other||Ratio of geometric means|0.987|||<|0.816|2-Sided|95.0|0.886|1.1|||Mixed Model Repeated Measures||Week 48. Urine Phosphate||
1600108|NCT02831673|2939596|Other||Ratio of geometric means|1.102|||<|0.099|2-Sided|95.0|0.982|1.237|||Mixed Model Repeated Measures||Week 24. Urine Phosphate||
1600184|NCT02826603|2939824|Superiority||Odds Ratio (OR)|1.84|||<|0.0001|2-Sided|95.0|1.41|2.41|||Regression, Logistic||||
1600110|NCT02831673|2939596|Other||Ratio of geometric means|0.64|||<|0.001|2-Sided|95.0|0.493|0.831|||Mixed Model Repeated Measures||Week 24. Urine B2M/Urine Creatinine||
1600111|NCT02831673|2939596|Other||Ratio of geometric means|0.891|||<|0.051|2-Sided|95.0|0.793|1.001|||Mixed Model Repeated Measures||Week 48. Urine Albumin/Creatinine||
1600112|NCT02831673|2939596|Other||Ratio of geometric means|0.965|||<|0.575|2-Sided|95.0|0.853|1.092|||Mixed Model Repeated Measures||Week 24. Urine Albumin/Creatinine||
1600113|NCT02831673|2939596|Other||Ratio of geometric means|0.672|||<|0.001|2-Sided|95.0|0.551|0.821|||Mixed Model Repeated Measures||Week 48. Urine B2M||
1600114|NCT02831673|2939596|Other||Ratio of geometric means|0.656|||<|0.005|2-Sided|95.0|0.491|0.877|||Mixed Model Repeated Measures||Week 24. Urine B2M||
1600115|NCT02831673|2939596|Other||Ratio of geometric means|0.904|||<|0.001|2-Sided|95.0|0.88|0.929|||Mixed Model Repeated Measures||Week 48. Serum B2M||
1600116|NCT02831673|2939596|Other||Ratio of geometric means|0.915|||<|0.001|2-Sided|95.0|0.887|0.943|||Mixed Model Repeated Measures||Week 24. Serum B2M||
1600117|NCT02831673|2939597|Other||Mean Difference (Net)|-3.22|||<|0.001|2-Sided|95.0|-4.54|-1.91|||Mixed Model Repeated Measures||Week 48||
1600118|NCT02831673|2939597|Other||Mean Difference (Net)|-3.19|||<|0.001|2-Sided|95.0|-4.62|-1.75|||Mixed Model Repeated Measures||Week 24||
1600119|NCT02831673|2939598|Other||Mean Difference (Net)|3.5|||<|0.001|2-Sided|95.0|2.0|5.1|||Mixed Model Repeated Measures||GFR- creatinine adjusted, Week 48||
1600120|NCT02831673|2939598|Other||Mean Difference (Net)|3.2|||<|0.001|2-Sided|95.0|1.6|4.8|||Mixed Model Repeated Measures||GFR-creatinine adjusted, Week 24||
1600121|NCT02831673|2939598|Other||Mean Difference (Net)|2.8|||<|0.001|2-Sided|95.0|1.2|4.5|||Mixed Model Repeated Measures||GFR-cystatin C adjusted, Week 48||
1600122|NCT02831673|2939598|Other||Mean Difference (Net)|2.2|||<|0.011|2-Sided|95.0|0.5|4.0|||Mixed Model Repeated Measures||GFR-cystatin C adjusted, Week 24||
1600123|NCT02831673|2939599|Other||Mean Difference (Net)|-0.1||||0.93|2-Sided|95.0|-1.4|1.2|||Mixed Model Repeated Measures||Serum RBP, Week 48||
1600124|NCT02831673|2939599|Other||Mean Difference (Net)|-0.3||||0.683|2-Sided|95.0|-1.6|1.0|||Mixed Model Repeated Measures||Serum RBP, Week 24||
1600125|NCT02831673|2939599|Other||Mean Difference (Net)|-0.03||||0.001|2-Sided|95.0|-0.05|-0.01|||Mixed Model Repeated Measures||Serum Cystatin C, Week 48||
1600126|NCT02831673|2939599|Other||Mean Difference (Net)|-0.02||||0.025|2-Sided|95.0|-0.04|0.0|||Mixed Model Repeated Measures||Serum Cystatin C, Week 24||
1600127|NCT02831673|2939609|Other||Mean Difference (Net)|4.6||||0.754|2-Sided|95.0|-23.9|33.0|||Mixed Model Repeated Measures (MMRM)||Week 48. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.||
1600128|NCT02831673|2939609|Other||Mean Difference (Net)|17.1||||0.206|2-Sided|95.0|-9.4|43.6|||Mixed Model Repeated Measures (MMRM)||Week 24. Following covariates/factors were adjusted: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction and Baseline CD4+ cell count and visit interaction with visit as the repeated factor.||
1600129|NCT02831673|2939611|Other||Hazard Ratio (HR)|1.01||||0.558|2-Sided|95.0|0.87|1.17||The generalized Wilcoxon procedure was used to estimate a p-value for detecting a difference in cumulative incidence curves between treatment groups.|Generalized Wilcoxon procedure||Hazard ratios were estimated using the Cox proportional hazard regression model. A hazard ratio of >1 indicates that DTG + 3TC is more likely to reach viral suppression earlier than DTG + TDF/FTC.||
1600130|NCT02831673|2939612|Other||Adjusted difference in proportion|-0.4|||||2-Sided|95.0|-4.2|3.4|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (<=vs.>100,000 c/mL) and CD4+ cell count (<= vs. >200 cells per cubic millimeter).||
1600131|NCT02831673|2939613|Non-Inferiority|Treatment with DTG+ 3TC was to be declared non-inferior to treatment with DTG+TDF/FTC if the lower end of a two-sided 95% confidence interval for the difference between the two groups in response rates at Week 48 greater than -10%.|Adjusted difference in proportion|-2.6|||||2-Sided|95.0|-6.7|1.5|||||Difference in proportion was based on CMH stratified analysis adjusting for Baseline stratification factors: Plasma HIV-1 RNA (<=versus [vs.]>100,000 c/mL) and cluster of differentiation 4+ (CD4+) cell count (<= vs. >200 cells per cubic millimeter).||
1600132|NCT02831387|2939617|Superiority||Mean Difference (Net)|1.666||||0.723|2-Sided|95.0|-7.759|11.092|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 15 (Visit 3) in the Subject-reported Dry Eye Symptom Score|
1600133|NCT02831387|2939618|Superiority||Odds Ratio (OR)|1.923|||||2-Sided|95.0|0.515|7.184||||||Statistical Analysis 1 for the Number of participants with at least 20% improvement in symptoms from baseline to Day 29|
1600134|NCT02831387|2939619|Superiority||Mean Difference (Net)|-0.2||||0.823|2-Sided|95.0|-1.9|1.5|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in Lissamine Green Staining of the Conjunctiva|
1600135|NCT02831387|2939620|Superiority||Mean Difference (Net)|0.6||||0.316|2-Sided|95.0|-0.6|1.9|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in Fluorescein Staining of the Cornea|
1600136|NCT02831387|2939621|Superiority||Mean Difference (Net)|3.9||||0.495|2-Sided|95.0|-7.6|15.4|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 29 in Severity Scores|
1600137|NCT02831387|2939622|Superiority||Mean Difference (Net)|-6.6||||0.267|2-Sided|95.0|-18.4|5.3|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline (Visit 2) to Day 29 in Frequency Scores|
1600138|NCT02831387|2939623|Superiority||Mean Difference (Net)|-1.88||||0.749|2-Sided|95.0|-13.696|9.936|||Mixed Models Analysis|||Statistical Analysis 1 for Change From Baseline to Day 29 in the Subject Reported Dry Eye Questionnaire|
1600139|NCT02828111|2939755|Other|Pairwise comparison||||||0.157|||||||Fisher Exact|||This is the analysis of all four patidegib gel treatment groups combined compared with combined vehicle gel at Week 12.|
1600140|NCT02828111|2939755|Other|Pairwise comparison||||||1|||||||Fisher Exact|||This is the analysis of combined patidegib gel 4% once daily and twice daily compared with vehicle gel at Week 12.|
1600185|NCT02826603|2939825|Superiority||Odds Ratio (OR)|2.85|||<|0.0001|2-Sided|95.0|2.19|3.71|||Regression, Logistic||||
1600141|NCT02828111|2939755|Other|Pairwise comparison||||||0.093|||||||Fisher Exact|||This is the analysis of combined patidegib gel 2% once daily and twice daily compared with vehicle gel at Week 12.|
1600142|NCT02828111|2939755|Other|Pairwise comparison||||||0.353|||||||Fisher Exact|||at Week 12|
1600143|NCT02828111|2939755|Other|Pairwise comparison||||||0.312|||||||Fisher Exact|||at Week 12|
1600144|NCT02828111|2939755|Other|Pairwise comparison||||||0.043|||||||Fisher Exact|||at Week 12|
1600145|NCT02828111|2939756|Other|Pairwise comparison||||||0.757|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12|
1600146|NCT02828111|2939756|Other|Pairwise comparison||||||0.198|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12|
1600147|NCT02828111|2939756|Other|Pairwise comparison||||||0.099|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12|
1600148|NCT02828111|2939756|Other|Pairwise comparison||||||0.038|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12|
1600149|NCT02828111|2939760|Other|Pairwise comparison||||||0.117|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of all four patidegib gel treatment groups combined compared with vehicle gel at Week 12.|
1600150|NCT02828111|2939760|Other|Pairwise comparison||||||0.331|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of combined patidegib gel 4% once daily and twice daily compared with vehicle gel at Week 12.|
1600151|NCT02828111|2939760|Other|Pairwise comparison||||||0.077|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||This is the analysis of combined patidegib gel 2% once daily and twice daily compared with vehicle gel at Week 12.|
1600152|NCT02828111|2939760|Other|Pairwise comparison||||||0.207|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12|
1600153|NCT02828111|2939760|Other|Pairwise comparison||||||0.142|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12|
1600154|NCT02828111|2939760|Other|Pairwise comparison||||||0.658|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12|
1600155|NCT02828111|2939760|Other|Pairwise comparison||||||0.132|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 12|
1600156|NCT02828020|2939762|Superiority||Odds Ratio (OR)|1.35||||0.0962|2-Sided|95.0|1.0|1.83||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.|||
1600157|NCT02828020|2939762|Superiority||Odds Ratio (OR)|1.31||||0.0962|2-Sided|95.0|0.96|1.79||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, nausea were explanatory variables.|||
1600158|NCT02828020|2939763|Superiority||Odds Ratio (OR)|1.47||||0.0577|2-Sided|95.0|1.1|1.95||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.|||
1600159|NCT02828020|2939763|Superiority||Odds Ratio (OR)|1.56||||0.0577|2-Sided|95.0|1.16|2.09||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, phonophobia were explanatory variables.|||
1600160|NCT02828020|2939764|Superiority||Odds Ratio (OR)|1.81||||0.0037|2-Sided|95.0|1.36|2.42||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.|||
1600161|NCT02828020|2939764|Superiority||Odds Ratio (OR)|1.63||||0.0577|2-Sided|95.0|1.22|2.19||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, photophobia were explanatory variables.|||
1600162|NCT02828020|2939765|Superiority||Odds Ratio (OR)|1.95||||0.0037|2-Sided|95.0|1.28|2.97||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1600163|NCT02828020|2939765|Superiority||Odds Ratio (OR)|1.57||||0.0577|2-Sided|95.0|1.01|2.44||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1600164|NCT02828020|2939766|Superiority||Odds Ratio (OR)|2.39||||0.0023|2-Sided|95.0|1.77|3.24||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1600165|NCT02828020|2939766|Superiority||Odds Ratio (OR)|2.25||||0.0023|2-Sided|95.0|1.65|3.07||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1600166|NCT02828020|2939767|Superiority||Odds Ratio (OR)|1.69||||0.0023|2-Sided|95.0|1.28|2.21||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1600167|NCT02828020|2939767|Superiority||Odds Ratio (OR)|1.69||||0.0023|2-Sided|95.0|1.28|2.23||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1600168|NCT02828020|2939768|Superiority||Odds Ratio (OR)|1.63||||0.0023|2-Sided|95.0|1.22|2.17||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.|||
1600169|NCT02828020|2939768|Superiority||Odds Ratio (OR)|1.7||||0.0023|2-Sided|95.0|1.27|2.28||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, migraine prevention medication, baseline headache severity, underlying symptom as explanatory variables.|||
1600170|NCT02828020|2939769|Superiority||Odds Ratio (OR)|2.04||||0.0003|2-Sided|95.0|1.41|2.95||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1600171|NCT02828020|2939769|Superiority||Odds Ratio (OR)|1.83||||0.0023|2-Sided|95.0|1.25|2.66||P-value was adjusted for multiple comparisons across primary and secondary endpoints and multiple doses.|Regression, Logistic|Treatment group, historical triptan response, medication use for migraine prevention, baseline headache severity were explanatory variables in model.|||
1600172|NCT02827708|2939791|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.43|||=|0|2-Sided|95.0|0.17|1.04||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1600173|NCT02827708|2939792|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.64|||=|0|2-Sided|95.0|0.34|1.23||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, interaction strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1600174|NCT02827708|2939808|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-2.7|||<|0.0001|2-Sided|95.0|-3.5|-1.9||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as covariate, all nested within visit, and an unstructured residual covariance matrix.|
1600175|NCT02827708|2939808|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-2.5|||<|0.0001|2-Sided|95.0|-3.2|-1.8||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1600176|NCT02827708|2939809|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Treatment difference|-1.0|||<|0.0001||95.0|-1.2|-0.8||Unadjusted two-sided p-value for test of no difference from 0.|MMRM||Oral semaglutide 14 mg - Placebo|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata, interaction strata and region as categorical fixed effects and the baseline value as covariate, all nested within visit, and an unstructured residual covariance matrix.|
1600177|NCT02827708|2939809|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Treatment difference|-0.8|||<|0.0001|2-Sided|95.0|-1.0|-0.6||Unadjusted two-sided p-value for test of no difference from 0.|Pattern Mixture model||Oral semaglutide 14 mg - Placebo|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1600178|NCT02827500|2939810|Superiority|||||||0.784|||||||Regression, Linear||||
1600179|NCT02827500|2939811|Superiority|||||||0.717|||||||Regression, Linear||||
1600180|NCT02827500|2939812|Superiority|||||||0.054||||||The apriori threshold for statistical significance is alpha=0.05.|Chi-squared, Corrected|The p-value is obtained using the F-test (combination of Chi-Squared tests) due to multiple imputation.||The null hypothesis tested was that there is no difference between the treatment arms in the proportion of patients with heart rate < 70 BPM.|
1600181|NCT02827500|2939813|Superiority|||||||0.011|||||||Regression, Linear|||The null hypothesis tested was that there is no difference in change in heart rate between the treatment arms.|
1600182|NCT02827500|2939814|Superiority|||||||0.011|||||||Regression, Linear||||
1600183|NCT02827500|2939815|Superiority||Odds Ratio, log|5.19||||0.002|2-Sided|95.0|1.88|14.33|||Regression, Logistic||||
1600186|NCT02826603|2939826|Superiority||Odds Ratio (OR)|2.86|||<|0.0001|2-Sided|95.0|1.96|4.17|||Regression, Logistic||||
1600187|NCT02826603|2939827|Superiority||Odds Ratio (OR)|2.5|||<|0.0001|2-Sided|95.0|1.89|3.31|||Regression, Logistic||||
1600188|NCT02826603|2939828|Superiority||Odds Ratio (OR)|2.57|||<|0.0001|2-Sided|95.0|1.96|3.37|||Regression, Logistic||||
1600189|NCT02826603|2939829|Superiority||Odds Ratio (OR)|2.33|||<|0.0001|2-Sided|95.0|1.8|3.01|||Regression, Logistic||||
1600190|NCT02826603|2939830|Superiority||Odds Ratio (OR)|3.53|||<|0.0001|2-Sided|95.0|2.65|4.71|||Regression, Logistic||||
1600191|NCT02826603|2939831|Superiority||Odds Ratio (OR)|2.62|||<|0.0001|2-Sided|95.0|1.89|3.62|||Regression, Logistic||||
1600192|NCT02826603|2939832|Superiority||Odds Ratio (OR)|2.1|||<|0.0001|2-Sided|95.0|1.63|2.72|||Regression, Logistic||||
1600193|NCT02826603|2939833|Superiority||Odds Ratio (OR)|2.21|||<|0.0001|2-Sided|95.0|1.72|2.84|||Regression, Logistic||||
1600194|NCT02825251|2939931|Non-Inferiority|Non-inferiority of faster aspart was considered confirmed if the upper limit of the two-sided 95 % CI for the true treatment-difference D (faster aspart minus NovoRapid®) was below 0.4 %.|Treatment difference|0.09|||||2-Sided|95.0|0.01|0.17||||||Change from baseline in HbA1c was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model included treatment, strata (use of own continuous glucose monitoring), previous insulin use, and region as factors, and baseline HbA1c as a covariate.|
1600195|NCT02824198|2939992|Non-Inferiority|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was > 1/2 for each serotype.|Geometric mean of titer ratio|1.27|||||2-Sided|95.0|0.918|1.75||||||Dengue Virus Serotype 4|
1600196|NCT02824198|2939992|Non-Inferiority|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was > 1/2 for each serotype.|Geometric mean of titer ratio|0.979|||||2-Sided|95.0|0.746|1.28||||||Dengue Virus Serotype 3|
1600197|NCT02824198|2939992|Non-Inferiority|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was > 1/2 for each serotype.|Geometric mean of titer ratio|0.603|||||2-Sided|95.0|0.439|0.829||||||Dengue Virus Serotype 2|
1600198|NCT02824198|2939992|Non-Inferiority|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (>) 1/2 for each serotype.|Geometric mean of titer ratio|1.34|||||2-Sided|95.0|0.998|1.79||||||Dengue Virus Serotype 1|
1600199|NCT02823080|2940007|Other||||||<|0.05|||||||ANOVA||||
1600200|NCT02823080|2940011|Other||||||<|0.05|||||||ANOVA||||
1600201|NCT02823080|2940012|Other||||||<|0.05|||||||ANOVA||||
1600202|NCT02823080|2940013|Other||||||<|0.05|||||||ANOVA||||
1600203|NCT02822885|2940019|Superiority or Other||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided||||
1600204|NCT02822885|2940020|Superiority or Other||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided||||
1600205|NCT02822885|2940021|Superiority or Other||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided||||
1600206|NCT02822885|2940022|Superiority or Other||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided||||
1600207|NCT02822885|2940023|Superiority or Other||||||<|0.05||||||All included p-values are calculated from collected data and not threshold values for statical significance|t-test, 2 sided||||
1600208|NCT02822794|2940052|Superiority||||||<|0.001|||||||Binomial test|P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL +RBV 24 Weeks (GT1) over the performance goal of 50%.|||
1600209|NCT02822794|2940052|Superiority||||||<|0.001|||||||Binomial test|P-value is obtained from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 Weeks (GT1) over the performance goal of 50%.|||
1600210|NCT02821910|2940107|Superiority or Other (legacy)||ratio (%)|101.61|Standard Deviation|14.9|||2-Sided|90.0|92.0|112.22|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600211|NCT02821910|2940107|Superiority or Other (legacy)||ratio (%)|105.72|Standard Deviation|11.7|||2-Sided|90.0|98.78|113.15|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600212|NCT02821910|2940107|Superiority or Other (legacy)||ratio (%)|95.08|Standard Deviation|12.6|||2-Sided|90.0|87.36|103.48|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600324|NCT02819726|2940327|Other|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 [AUEC(0-d15)]|Statistical Comparisons Difference|47.4|||||2-Sided|90.0|-112.5|207.2||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.|
1638159|NCT01951326|3011110|Superiority|||||||0.2402|||||||Log Rank||||
1600213|NCT02821910|2940108|Superiority or Other (legacy)||ratio (%)|98.45|Standard Deviation|9.4|||2-Sided|90.0|92.44|104.85|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600214|NCT02821910|2940108|Superiority or Other (legacy)||ratio (%)|95.4|Standard Deviation|14.9|||2-Sided|90.0|87.5|104.01|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600215|NCT02821910|2940108|Superiority or Other (legacy)||ratio (%)|96.57|Standard Deviation|8.9|||2-Sided|90.0|90.94|102.56|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600216|NCT02821910|2940109|Superiority or Other (legacy)||ratio (%)|99.75|Standard Deviation|6.0|||2-Sided|90.0|95.81|103.86|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600217|NCT02821910|2940109|Superiority or Other (legacy)||ratio (%)|100.87|Standard Deviation|5.0|||2-Sided|90.0|97.96|103.86|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600218|NCT02821910|2940109|Superiority or Other (legacy)||ratio (%)|96.63|Standard Deviation|5.8|||2-Sided|90.0|92.86|100.54|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600219|NCT02821910|2940110|Superiority or Other (legacy)||ratio (%)|100.31|Standard Deviation|5.9|||2-Sided|90.0|96.41|104.38|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600220|NCT02821910|2940110|Superiority or Other (legacy)||ratio (%)|105.07|Standard Deviation|8.6|||2-Sided|90.0|99.95|110.45|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600221|NCT02821910|2940110|Superiority or Other (legacy)||ratio (%)|96.34|Standard Deviation|6.6|||2-Sided|90.0|92.13|100.75|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600222|NCT02821910|2940111|Superiority or Other (legacy)||ratio (%)|102.74|Standard Deviation|6.2|||2-Sided|90.0|98.56|107.1|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600223|NCT02821910|2940111|Superiority or Other (legacy)||ratio (%)|117.31|Standard Deviation|22.0|||2-Sided|90.0|103.41|133.07|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1602236|NCT02756689|2943616|Superiority|||||||0.24|||||||Wilcoxon (Mann-Whitney)||||
1600224|NCT02821910|2940111|Superiority or Other (legacy)||ratio (%)|97.5|Standard Deviation|12.0|||2-Sided|90.0|89.94|105.71|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600225|NCT02821910|2940112|Superiority or Other (legacy)||ratio (%)|101.24|Standard Deviation|10.1|||2-Sided|90.0|94.58|108.38|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600226|NCT02821910|2940112|Superiority or Other (legacy)||ratio (%)|100.04|Standard Deviation|17.9|||2-Sided|90.0|90.23|110.91|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600227|NCT02821910|2940112|Superiority or Other (legacy)||ratio (%)|97.97|Standard Deviation|10.2|||2-Sided|90.0|91.46|104.94|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600228|NCT02821910|2940113|Superiority or Other (legacy)||ratio (%)|100.41|Standard Deviation|8.9|||2-Sided|90.0|94.54|106.64|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600229|NCT02821910|2940113|Superiority or Other (legacy)||ratio (%)|106.63|Standard Deviation|9.9|||2-Sided|90.0|100.65|112.96|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600230|NCT02821910|2940113|Superiority or Other (legacy)||ratio (%)|94.94|Standard Deviation|13.8|||2-Sided|90.0|86.6|104.08|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600231|NCT02821910|2940114|Superiority or Other (legacy)||ratio (%)|98.47|Standard Deviation|9.9|||2-Sided|90.0|92.12|105.25|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600232|NCT02821910|2940114|Superiority or Other (legacy)||ratio (%)|95.67|Standard Deviation|15.5|||2-Sided|90.0|87.44|104.68|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600233|NCT02821910|2940114|Superiority or Other (legacy)||ratio (%)|96.82|Standard Deviation|9.7|||2-Sided|90.0|90.65|103.42|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600234|NCT02821910|2940115|Superiority or Other (legacy)||ratio (%)|99.83|Standard Deviation|5.9|||2-Sided|90.0|95.96|103.85|||||Relative bioavailability was estimated by the adjusted gMean ratio of T3 divided by R3. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1669887|NCT01387815|3072817|Other|||||||0.695|||||||t-test, 2 sided||||
1600235|NCT02821910|2940115|Superiority or Other (legacy)||ratio (%)|100.8|Standard Deviation|4.8|||2-Sided|90.0|97.99|103.7|||||Relative bioavailability was estimated by the adjusted gMean ratio of T2 divided by R2. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600236|NCT02821910|2940115|Superiority or Other (legacy)||ratio (%)|96.7|Standard Deviation|5.9|||2-Sided|90.0|92.89|100.66|||||Relative bioavailability was estimated by the adjusted gMean ratio of T1 divided by R1. Standard deviation is actually intra-individual geometric coefficient variation (gCV).|The statistical model used was an Analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed.|
1600237|NCT02821819|2940116|Non-Inferiority|Statistical analysis was performed using t-student test for continuous variables and chi-square test for categorical parameters. A P value of <.05 was considered significant.|Median Difference (Final Values)|71.1|||<|0.05|2-Sided||||||Chi-squared||||
1600238|NCT02821819|2940117|Non-Inferiority|The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60). Statistical analysis used t-student test for continuous variables and chi-square test for categorical parameters.|Mean Difference (Final Values)|82.0||||0.8|2-Sided|||||a priori threshold for statistical significance: <0.05|Chi-squared|||The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60). Statistical analysis used t-student test for continuous variables and chi-square test for categorical parameters.|
1600239|NCT02821819|2940117|Non-Inferiority|The sample size was calculated assuming a non-inferiority margin of 5 eggs SD 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).|Mean Difference (Final Values)|18.0|Standard Deviation|8.1||0.8|1-Sided|||||a priori threshold for statistical significance: <0.05|t-test, 1 sided|||The sample size was calculated assuming a non-inferiority margin of 5 eggs and a standard deviation (SD) of 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).|"Since the number of collected eggs constitutes the main outcome of the study, the sample size was calculated assuming a non-inferiority margin of 5 eggs with an standard deviation of 6.7. A unilateral alpha level of 0.05 was stablished. With the aim to show that the difference in the mean number of collected eggs will not exceed 5, a statistical power of 80% required 30 patients per group (1:1 allocation, total sample: 60).~Statistical analysis was performed using t-student test for continuous variables and chi-square test for categorical parameters. A P value of <.05 was considered significant."
1600240|NCT02821338|2940126|Equivalence|90% confidence interval falls within 80.00-125.00%|Test/Reference Ratio|1.047|||||2-Sided|90.0|1.0079|1.0877|||||||
1600241|NCT02821338|2940127|Equivalence|90% confidence interval falls within 80.00-125.00%|Test/Reference Ratio|0.9785|||||2-Sided|90.0|0.9484|1.0095|||||||
1600242|NCT02821338|2940128|Equivalence|90% confidence interval falls within 80.00-125.00%|Test/Reference ratio|0.9863|||||2-Sided|90.0|0.9598|1.0134||||||90% confidence interval of the geometric mean ratio of test/reference|
1600243|NCT02820870|2940151|Superiority||Odds Ratio (OR)|1.65||||0.06|2-Sided|95.0|0.99|2.77|||Regression, Logistic|With cluster by provider and team.|||
1600244|NCT02820870|2940152|Superiority||Odds Ratio (OR)|3.0|||<|0.01|2-Sided|95.0|1.84|4.9|||Regression, Logistic|With clustering by provider and team.|||
1600245|NCT02820844|2940214|Other||Hazard Ratio (HR)|0.5|||<|0.001|2-Sided|95.0|0.38|0.66||P-value is from log-rank test stratified by Baseline urinary urgency incontinence episodes over 3 day diary (<=9 versus >=10)|Log Rank||Hazard ratio and 95% CI are estimated using the Cox proportional hazard model with treatment and Baseline urinary urgency incontinence episodes over 3 day diary (<=9 versus >=10) as fixed effect.||
1600246|NCT02820844|2940215|Other||Hazard Ratio (HR)|0.45|||<|0.001|2-Sided|95.0|0.34|0.6||P-value is from log-rank test stratified by Baseline urinary urgency incontinence episodes over 3 day diary (<=9 versus >=10).|Log Rank||Hazard ratio and 95% Confidence Interval (CI) are estimated using the Cox proportional hazard model with treatment and Baseline urinary urgency incontinence episodes over 3 day diary (<=9 versus >=10) as fixed effect.||
1600247|NCT02820844|2940270|Other||Mean Difference (Net)|29.69|||<|0.001|2-Sided|95.0|18.47|40.91||Analysis performed using MMRM, with treatment, site, visit, Baseline urinary urgency incontinence (UUI) episodes over 3 day diary (<=9 or >=10), treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|MMRM||Mean difference (Net) at Week 12 has been presented.||
1600248|NCT02820844|2940271|Other||Mean Difference (Net)|-2.16|||<|0.001|2-Sided|95.0|-3.14|-1.18||Analysis was performed using mixed-model for repeated measures (MMRM) with treatment, site, visit, treatment-by-visit interaction, Baseline value, Baseline-by-visit interaction as fixed effects.|MMRM||Mean difference (Net) at Week 12 has been presented.||
1600249|NCT02820597|2940274|Superiority||||||<|0.001||||||Paired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.|t-test, 2 sided|||Null hypothesis is that the within-participant change from baseline in rhinitis symptoms VAS is 0.|
1600250|NCT02820597|2940275|Superiority||||||<|0.001|||||||t-test, 2 sided|Paired t-tests on the mean change from baseline. No adjustments were made for multiple comparisons.||Null hypothesis is that the within-participant change from baseline in rTNSS is 0.|
1600418|NCT02816138|2940523|Other|||||||0.073|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test assessing for change from baseline to 12-weeks|
1602237|NCT02756689|2943617|Superiority|||||||0.39|||||||Wilcoxon (Mann-Whitney)||||
1600251|NCT02820038|2940277|Superiority|Regression model adjusted for baseline value of the dependent variable.|Odds Ratio (OR)|1.15||||0.81|2-Sided|95.0|0.37|3.54|||Regression, Logistic||Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, DrugFactsBox® (DFB) Only; 1=Other CMI+SMART, DFB+SMART|The investigators hypothesized that participants would experience a greater increase in the percentage of participants using at least one DMARD (Disease-Modifying Antirheumatic Drug) between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600252|NCT02820038|2940277|Superiority|Regression model adjusted for baseline value of the dependent variable.|Odds Ratio (OR)|0.75||||0.63|2-Sided|95.0|0.24|2.35|||Regression, Logistic||. Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART; 1=DFB Only, DFB+SMART|The investigators hypothesized that participants would exhibit a greater increase in the percentage of participants using at least one DMARD (Disease-Modifying Antirheumatic Drug) between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600253|NCT02820038|2940277|Superiority||Odds Ratio (OR)|0.91||||0.9|2-Sided|95.0|0.22|3.81|||Regression, Logistic||Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART, DrugFactsBox® (DFB) Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to be using at least one DMARD (Disease-Modifying Antirheumatic Drug) at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600254|NCT02820038|2940278|Superiority||Mean Difference (Net)|-0.84|Standard Error of the Mean|0.45||0.0601|2-Sided|95.0|-1.71|0.04|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would view more webpages if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600255|NCT02820038|2940279|Superiority||Odds Ratio (OR)|2.105||||0.0028|2-Sided|95.0|1.291|3.432|||Regression, Logistic|||The investigators hypothesized that participants would be more likely to view at least one webpage if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|Modeled probability of viewing at least one webpage. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.
1600256|NCT02820038|2940280|Superiority||Mean Difference (Net)|0.001|Standard Error of the Mean|0.1||0.99|2-Sided|95.0|-0.19|0.19|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-week follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600257|NCT02820038|2940280|Superiority||Mean Difference (Net)|0.12|Standard Error of the Mean|0.1||0.2|2-Sided|95.0|-0.06|0.31|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600258|NCT02820038|2940280|Superiority||Mean Difference (Net)|0.05|Standard Error of the Mean|0.12||0.68|2-Sided|95.0|-0.19|0.29|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater verbatim recall of information concerning medication benefits and risks at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600259|NCT02820038|2940281|Superiority||Mean Difference (Net)|-1.8|Standard Error of the Mean|1.2||0.13|2-Sided|95.0|-4.2|0.6|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would experience greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600260|NCT02820038|2940281|Superiority||Mean Difference (Net)|-2.1|Standard Error of the Mean|1.2||0.07|2-Sided|95.0|-4.4|0.3|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600261|NCT02820038|2940281|Superiority||Mean Difference (Net)|-2.2|Standard Error of the Mean|0.15||0.15|2-Sided|95.0|-5.2|0.8|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater medication self-management knowledge at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600419|NCT02816138|2940524|Other|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test assessing for change from baseline to 12-weeks|
1600420|NCT02816138|2940525|Other|||||||0.761|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test|||
1600262|NCT02820038|2940282|Superiority|Regression model adjusted for baseline values of the dependent variable.|Mean Difference (Net)|5.6|Standard Error of the Mean|6.9||0.42|2-Sided|95.0|-8.1|19.2|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would experience a greater increase in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600263|NCT02820038|2940282|Superiority|Regression model adjusted for baseline value of the dependent variable|Mean Difference (Net)|16.0|Standard Error of the Mean|6.9||0.02|2-Sided|95.0|2.5|29.5|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600264|NCT02820038|2940282|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|11.9|Standard Error of the Mean|8.7||0.17|2-Sided|95.0|-5.2|28.9|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in visual selective learning between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600265|NCT02820038|2940283|Superiority||Odds Ratio (OR)|0.614||||0.1278|2-Sided|95.0|0.328|1.15|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART.|The investigators hypothesized that participants would be more likely to visit the RA Self-Management Website if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600266|NCT02820038|2940283|Superiority||Odds Ratio (OR)|1.425||||0.1278|2-Sided|95.0|0.766|2.649|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|The investigators hypothesized that participants would be more likely to visit the RA Self-Management Website if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600267|NCT02820038|2940283|Superiority||Odds Ratio (OR)|0.804||||0.574|2-Sided|95.0|0.38|1.72|||Regression, Logistic||Modeled probability of viewing at least one page on website. Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to use the RA Self-Management website if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600268|NCT02820038|2940284|Superiority||Odds Ratio (OR)|0.679||||0.2211|2-Sided|95.0|0.366|1.262|||Regression, Logistic||Modeled probability of attending at least one class. Independent variable coded: 0=Other CMI Only, DFB Only; 1=Other CMI+SMART, DFB+SMART.|The investigators hypothesized that participants would be more likely to participate in at least one session of the BetterChoices, BetterHealth program if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600269|NCT02820038|2940284|Superiority||Odds Ratio (OR)|1.189||||0.5815|2-Sided|95.0|0.643|2.198|||Regression, Logistic||Modeled probability of attending at least one class. Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART.|The investigators hypothesized that participants would be more likely to participate in at least one session of the BetterChoices,BetterHealth program if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600270|NCT02820038|2940284|Superiority||Odds Ratio (OR)|0.9||||0.7871|2-Sided|95.0|0.43|1.89|||Regression, Logistic||Modeled probability of attending at least one class session. Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to participate in the BetterChoices, BetterHealth program if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600271|NCT02820038|2940285|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.31|Standard Error of the Mean|3.24||0.924|2-Sided|95.0|-6.66|6.05|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in health literacy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600272|NCT02820038|2940285|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.67|Standard Error of the Mean|3.24||0.605|2-Sided|95.0|-4.68|8.01|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in health literacy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600325|NCT02819726|2940327|Other|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 [AUEC(0-d15)]|Statistical Comparisons Difference|69.5|||||2-Sided|90.0|-91.8|230.8||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.|
1600273|NCT02820038|2940285|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|2.52|Standard Error of the Mean|4.1||0.5364|2-Sided|95.0|-5.51|10.55|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in health literacy at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600274|NCT02820038|2940286|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.47|Standard Error of the Mean|0.81||0.5655|2-Sided|95.0|-2.06|1.13|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in fatigue between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600275|NCT02820038|2940286|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.89|Standard Error of the Mean|0.81||0.2691|2-Sided|95.0|-2.48|0.7|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in fatigue between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600276|NCT02820038|2940286|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.3|Standard Error of the Mean|1.04||0.2123|2-Sided|95.0|-3.34|0.75|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in fatigue at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600277|NCT02820038|2940287|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.35|Standard Error of the Mean|0.62||0.5766|2-Sided|95.0|-1.57|0.87|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in depression between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600278|NCT02820038|2940287|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.29|Standard Error of the Mean|0.62||0.6312|2-Sided|95.0|-1.5|0.91|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in depression between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600279|NCT02820038|2940287|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.09|Standard Error of the Mean|0.8||0.9128|2-Sided|95.0|-1.65|1.48|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in depression at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600280|NCT02820038|2940288|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.01|Standard Error of the Mean|0.21||0.9476|2-Sided|95.0|-0.42|0.4|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in disease activity between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600281|NCT02820038|2940288|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.11|Standard Error of the Mean|0.21||0.5941|2-Sided|95.0|-0.3|0.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in disease activity between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600282|NCT02820038|2940288|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.1|Standard Error of the Mean|0.27||0.7093|2-Sided|95.0|-0.43|0.63|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in disease activity at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1669888|NCT01387815|3072818|Other|||||||0.419|||||||t-test, 2 sided||||
1600283|NCT02820038|2940289|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.02|Standard Error of the Mean|0.08||0.7603|2-Sided|95.0|-0.13|0.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater improvement in global health status between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600284|NCT02820038|2940289|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.01|Standard Error of the Mean|0.08||0.8766|2-Sided|95.0|-0.14|0.16|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in global health status between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600285|NCT02820038|2940289|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.05|Standard Error of the Mean|0.1||0.6403|2-Sided|95.0|-0.15|0.25|||Regression, Linear|||The investigators hypothesized that participants would exhibit greater increases in health status at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600286|NCT02820038|2940290|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.02|Standard Error of the Mean|0.13||0.8848|2-Sided|95.0|-0.28|0.24|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in health distress between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600287|NCT02820038|2940290|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.11|Standard Error of the Mean|0.13||0.4186|2-Sided|95.0|-0.36|0.15|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in health distress between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600288|NCT02820038|2940290|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.23|Standard Error of the Mean|0.17||0.1762|2-Sided|95.0|-0.57|0.1|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group..|The investigators hypothesized that participants would exhibit greater decreases in health distress at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600289|NCT02820038|2940291|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.024|Standard Error of the Mean|2.11||0.9106|2-Sided|95.0|-4.38|3.9|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in illness intrusiveness between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600290|NCT02820038|2940291|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|4.19|Standard Error of the Mean|2.11||0.0466|2-Sided|95.0|0.06|8.32|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater decrease in illness intrusiveness between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600291|NCT02820038|2940291|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|2.79|Standard Error of the Mean|2.73||0.3056|2-Sided|95.0|-2.56|8.14|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater decreases in illness intrusiveness at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600292|NCT02820038|2940292|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|3.92|Standard Error of the Mean|1.66||0.0184|2-Sided|95.0|0.67|7.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in medication adherence between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600421|NCT02816138|2940526|Other||||||<|0.001|||||||Regression, Linear|For change in depression severity (MADRS) over time, we used a linear mixed effects model with autoregressive of order 1 (AR(1)) temporal process.|||
1600293|NCT02820038|2940292|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-3.62|Standard Error of the Mean|1.64||0.0279|2-Sided|95.0|-6.84|-0.4|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in adherence between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600294|NCT02820038|2940292|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.1|Standard Error of the Mean|2.19||0.9604|2-Sided|95.0|-4.4|4.18|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in medication adherence at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600295|NCT02820038|2940293|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.45|Standard Error of the Mean|2.3||0.5264|2-Sided|95.0|-3.05|5.95|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in self-efficacy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600296|NCT02820038|2940293|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|Standard Error of the Mean|2.29||0.8841|2-Sided|95.0|-4.16|4.83|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in self-efficacy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600297|NCT02820038|2940293|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|3.48|Standard Error of the Mean|2.95||0.2366|2-Sided|95.0|-2.3|9.26|||Regression, Linear|||The investigators hypothesized that participants would exhibit greater increases in self-efficacy at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600298|NCT02820038|2940294|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|1.66|Standard Error of the Mean|2.14||0.4356|2-Sided|95.0|-2.53|5.86|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600299|NCT02820038|2940294|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.35|Standard Error of the Mean|2.13||0.8689|2-Sided|95.0|-3.82|4.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600300|NCT02820038|2940294|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.48|Standard Error of the Mean|2.74||0.5866|2-Sided|95.0|-6.85|3.89|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in satisfaction at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600301|NCT02820038|2940295|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|Standard Error of the Mean|0.5||0.5094|2-Sided|95.0|-0.65|1.31|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600302|NCT02820038|2940295|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.26|Standard Error of the Mean|0.5||0.597|2-Sided|95.0|-0.71|1.23|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in satisfaction between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600422|NCT02815982|2940527|Superiority||Mean Difference (Final Values)|-348.9|||<|0.12|2-Sided|95.0|-2762.5|2064.8||p < .05 was the threshold|t-test, 2 sided|||We compared Post-intervention scores|
1602238|NCT02756689|2943618|Superiority|||||||0.57|||||||Wilcoxon (Mann-Whitney)||||
1600303|NCT02820038|2940295|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.33|Standard Error of the Mean|0.64||0.6084|2-Sided|95.0|-0.93|1.58|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in satisfaction at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600304|NCT02820038|2940296|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.06|Standard Error of the Mean|0.2||0.7777|2-Sided|95.0|-0.33|0.44|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600305|NCT02820038|2940296|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.14|Standard Error of the Mean|0.19||0.4821|2-Sided|95.0|-0.25|0.52|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600306|NCT02820038|2940296|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.17|Standard Error of the Mean|0.25||0.507|2-Sided|95.0|-0.33|0.66|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater gist reasoning ability at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600307|NCT02820038|2940297|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.03|Standard Error of the Mean|0.18||0.8637|2-Sided|95.0|-0.32|0.38|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600308|NCT02820038|2940297|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.12|Standard Error of the Mean|0.18||0.4888|2-Sided|95.0|-0.47|0.22|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in gist reasoning ability between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600309|NCT02820038|2940297|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.33|Standard Error of the Mean|0.23||0.1486|2-Sided|95.0|-0.77|0.12|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit greater increases in gist reasoning ability at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600310|NCT02820038|2940298|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.27|Standard Error of the Mean|0.42||0.509|2-Sided|95.0|-0.54|1.09|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in values favoring aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600311|NCT02820038|2940298|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.36|Standard Error of the Mean|0.42||0.3843|2-Sided|95.0|-0.45|1.17|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART; 1=DFB Only, DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in values favoring aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600326|NCT02819726|2940327|Other|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day 15 [AUEC(0-d15)]|Statistical Comparisons Difference|22.1|||||2-Sided|90.0|-137.1|181.3||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.|
1600327|NCT02819726|2940333|Other||Difference (%)|-1.1|Standard Error of the Mean|7.29|||2-Sided|95.0|-15.14|12.91||||||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.|
1600312|NCT02820038|2940298|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|0.05|Standard Error of the Mean|0.53||0.9216|2-Sided|95.0|-0.98|1.08|||Regression, Linear|||The investigators hypothesized that participants would exhibit a greater increase in values favorable to aggressive therapy between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.
1600313|NCT02820038|2940299|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-2.19|Standard Error of the Mean|1.05||0.0377|2-Sided|95.0|-4.25|-0.13|||Regression, Linear||Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600314|NCT02820038|2940299|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-0.28|Standard Error of the Mean|1.05||0.7892|2-Sided|95.0|-2.33|1.77|||Regression, Linear|||The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|Independent variable coded: 0=Other CMI Only, DFB Only; 1=DFB+SMART, Other CMI+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.
1600315|NCT02820038|2940299|Superiority|Regression model adjusted for baseline value of the dependent variable.|Mean Difference (Net)|-1.83|Standard Error of the Mean|1.32||0.163|2-Sided|95.0|-1.83|0.75|||Regression, Linear||Independent variable coded: 0=Other CMI Only, Other CMI+SMART, DFB Only; 1=DFB+SMART. Difference score calculated as: Comparison Group - Intervention Group. Thus, negative values indicate mean was greater in the intervention group.|The investigators hypothesized that participants would exhibit a greater increase in knowledge between baseline and the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600316|NCT02820038|2940300|Superiority||Odds Ratio (OR)|0.53||||0.2216|2-Sided|95.0|0.19|1.48|||Regression, Logistic||Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|In this analysis, participants were restricted to those who met the criteria for informed decision-making at baseline.|
1600317|NCT02820038|2940300|Superiority||Odds Ratio (OR)|2.379||||0.0193|2-Sided|95.0|1.15|4.92|||Regression, Logistic|Sample restricted to participants who did not meet the criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|In this analysis, participants were restricted to those who did not meet criteria for informed decision-making at baseline.|
1600318|NCT02820038|2940300|Superiority||Odds Ratio (OR)|1.48||||0.1937|2-Sided|95.0|0.82|2.68|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or DFB Only, 1=Other CMI + SMART or DFB+SMART.|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive gist reasoning training, delivered via the SMART Program, compared to those who were not assigned to receive this training.|
1600319|NCT02820038|2940300|Superiority||Odds Ratio (OR)|1.18||||0.58|2-Sided|95.0|0.66|2.12|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other CMI Only or Other CMI+SMART, 1=DFB or DFB + SMART|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive written medication information via the DrugFactsBox® format compared to the Other CMI format.|
1600320|NCT02820038|2940300|Superiority||Odds Ratio (OR)|1.08||||0.8408|2-Sided|95.0|0.52|2.24|||Regression, Logistic|Regression model adjusted for whether participant met criteria for informed decision making at baseline.|Modeled probability of meeting criteria for informed decision making at the 6-month follow-up. Independent variable coded: 0=Other Consumer Medication Information (CMI) Only, Other CMI+SMART, DrugFactsBox® (DFB) Only; 1=DFB+SMART|The investigators hypothesized that participants would be more likely to meet the criteria for Informed Decision-Making at the 6-month follow-up if they were assigned to receive medication information via the DrugFactsBox® format combined with gist reasoning training, delivered via the SMART Program, compared to individuals in the other three groups.|
1600321|NCT02819726|2940327|Other|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week [AUEC(0-w24)]|Statistical Comparisons Difference|-14.6|||||2-Sided|90.0|-527.4|498.2||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.|
1600322|NCT02819726|2940327|Other|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week [AUEC(0-w24)]|Statistical Comparisons Difference|296.1|||||2-Sided|90.0|-213.8|806.1||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.|
1600323|NCT02819726|2940327|Other|Statistical comparison of CD19+ B-cell pharmacokinetic parameters at Day week [AUEC(0-w24)]|Statistical Comparisons Difference|310.7|||||2-Sided|90.0|-187.9|809.4||||||The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.|
1600412|NCT02816138|2940517|Other|||||||0.068|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test|||
1669889|NCT01387815|3072819|Other|||||||0.469|||||||t-test, 2 sided||||
1600328|NCT02819726|2940333|Other||Difference (%)|0.2|Standard Error of the Mean|7.21|||2-Sided|95.0|-13.75|14.03||||||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.|
1600329|NCT02819726|2940333|Other||Difference (%)|1.3|Standard Error of the Mean|7.19|||2-Sided|95.0|-12.59|15.1||||||Week 52 EULAR score 'Good'. EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The 95% CIs for EULAR response rate and treatment difference were derived using the Wilson Score method.|
1600330|NCT02819726|2940334|Other||Differnce (%)|-0.1|Standard Error of the Mean|2.27|||2-Sided|95.0|-6.05|5.83||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.|
1600331|NCT02819726|2940334|Other||Difference (%)|-1.2|Standard Error of the Mean|1.95|||2-Sided|95.0|-7.07|3.86||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.|
1600332|NCT02819726|2940334|Other||Difference (%)|-1.2|Standard Error of the Mean|1.92|||2-Sided|95.0|-6.9|3.9||||||Week 52 (EOS). Clinical remission is defined as score of Simplified Disease Activity Index (SDAI) smaller than 3.3. The 95% CIs for clinical remission rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.|
1600333|NCT02819726|2940335|Other||Difference (%)|-1.3|Standard Error of the Mean|1.24|||2-Sided|95.0|-6.75|3.39||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.|
1600334|NCT02819726|2940335|Other||Difference (%)|1.0|Standard Error of the Mean|2.0|||2-Sided|95.0|-4.74|6.67||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.|
1600335|NCT02819726|2940335|Other||Difference (%)|2.2|Standard Error of the Mean|1.57|||2-Sided|95.0|-2.56|7.83||||||Week 52 (EOS) Major Clinical Response. The 95% CIs for major clinical response rate and treatment difference were derived using the Wilson Score method. The adjusted difference and its 95% CI are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP as a covariate.|
1600336|NCT02819726|2940336|Other||LS Means Diference|0.03|Standard Error of the Mean|0.205||0.8962|2-Sided|95.0|-0.376|0.43|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.|
1600337|NCT02819726|2940336|Other||LS Measn Difference|0.05|Standard Error of the Mean|0.201||0.05|2-Sided|95.0|-0.351|0.442|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.|
1600338|NCT02819726|2940336|Other||LS Means Difference|0.02|Standard Error of the Mean|0.2||0.9249|2-Sided|95.0|-0.375|0.413|||ANCOVA|||Week 52 ( EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-ESR value as a covariate. ANCOVA model contains treatment group only.|
1600339|NCT02819726|2940337|Other||LS Means Difference|1.94|Standard Error of the Mean|1.885||0.3035|2-Sided|95.0|-1.768|5.655|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).|
1600340|NCT02819726|2940337|Other||LS Means Difference|1.51|Standard Error of the Mean|1.868||0.4186|2-Sided|95.0|-2.164|5.191|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).|
1600341|NCT02819726|2940337|Other||LS Means Difference|-0.43|Standard Error of the Mean|1.871||0.8183|2-Sided|95.0|-4.113|3.253|||ANCOVA|||Week 52 (EOS) CRP. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).|
1600342|NCT02819726|2940338|Other||LS Means Difference|0.03|Standard Error of the Mean|0.087||0.7111|2-Sided|95.0|-0.139|0.204|||ANCOVA|||Week 52 (EOS) HAQ-DI )0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).|
1600343|NCT02819726|2940338|Other||LS Means Difference|-0.14|Standard Error of the Mean|0.086||0.1141|2-Sided|95.0|-0.307|0.033|||ANCOVA|||Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).|
1600344|NCT02819726|2940338|Other||LS Means Difference|-0.14|Standard Error of the Mean|0.086||0.0505|2-Sided|95.0|-0.339|0.0|||ANCOVA|||Week 52 (EOS) HAQ-DI (0-3). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).|
1600345|NCT02819726|2940339|Other||LS Means Difference|-0.2|Standard Error of the Mean|3.494||0.9548|2-Sided|95.0|-7.078|6.682|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)|
1600413|NCT02816138|2940518|Other|||||||0.049|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test|||
1600414|NCT02816138|2940519|Other|||||||0.502|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test|||
1600346|NCT02819726|2940339|Other||LS Means Difference|-1.48|Standard Error of the Mean|3.453||0.6683|2-Sided|95.0|-8.28|5.317|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)|
1600347|NCT02819726|2940339|Other||LS Means Difference|-1.28|Standard Error of the Mean|3.443||0.7097|2-Sided|95.0|-8.062|5.496|||ANCOVA|||Week 52 (EOS) Participants Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)|
1600348|NCT02819726|2940340|Other||LS Means Difference|-0.98|Standard Error of the Mean|3.633||0.7869|2-Sided|95.0|-8.136|6.169|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).|
1600349|NCT02819726|2940340|Other||LS Means Difference|-2.21|Standard Error of the Mean|3.623||0.5418|2-Sided|95.0|-9.347|4.92|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).|
1600350|NCT02819726|2940340|Other||LS Means Difference|-1.23|Standard Error of the Mean|3.592||0.7322|2-Sided|95.0|-8.0302|5.841|||ANCOVA|||Week 52 (EOS) Participants Pain Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline).|
1600351|NCT02819726|2940341|Other||LS Means Difference|3.77|Standard Error of the Mean|3.268||0.2498|2-Sided|95.0|-2.665|10.204|||ANCOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline|
1600352|NCT02819726|2940341|Other||LS Means Difference|-0.39|Standard Error of the Mean|3.242||-0.39|2-Sided|95.0|-6.771|5.994|||ANOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline|
1600353|NCT02819726|2940341|Other||LS Means Difference|-4.16|Standard Error of the Mean|3.242||0.2008|2-Sided|95.0|-10.541|2.226|||ANCOVA|||Week 52 (EOS) Physician's Disease Activity Assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate. Change from Study Day 1 (Baseline)|
1600354|NCT02819726|2940342|Other||LS Means Difference|1.19|Standard Error of the Mean|1.52||0.4352|2-Sided|95.0|-1.805|4.18|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.|
1600355|NCT02819726|2940342|Other||LS Means Difference|-0.77|Standard Error of the Mean|1.5||-0.77|2-Sided|95.0|-3.722|2.184|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.|
1600356|NCT02819726|2940342|Other||LS Means Difference|-1.96|Standard Error of the Mean|1.5||0.1931|2-Sided|95.0|-4.909|0.996|||ANCOVA|||Tender Joint Count (TJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.|
1600357|NCT02819726|2940342|Other||LS Means Difference|1.17|Standard Error of the Mean|1.008||0.248|2-Sided|95.0|-0.817|3.15|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.|
1600358|NCT02819726|2940342|Other||LS Means Difference|-0.11|Standard Error of the Mean|0.996||0.9098|2-Sided|95.0|-2.074|1.848|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.|
1600359|NCT02819726|2940342|Other||LS Means Difference|-1.28|Standard Error of the Mean|0.991||0.1997|2-Sided|95.0|-3.23|0.671|||ANCOVA|||Swollen Joint Count (SJC) Week 52 (EOS) assessment. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and baseline value as a covariate.|
1600360|NCT02819726|2940343|Other||Difference (%)|-4.7|Standard Error of the Mean|5.58|||2-Sided|92.0|-15.68|6.41||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.|
1600361|NCT02819726|2940343|Other||Difference|5.4|Standard Error of the Mean|6.08|||2-Sided|95.0|-6.69|17.13||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.|
1600362|NCT02819726|2940343|Other||Difference (%)|10.0|Standard Error of the Mean|5.78|||2-Sided|95.0|-1.52|21.22||||||ACR70 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.|
1600363|NCT02819726|2940343|Other||Difference (%)|-5.9|Standard Error of the Mean|6.88|||2-Sided|95.0|-19.1|7.51||||||ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.|
1600364|NCT02819726|2940343|Other||Difference (%)|3.5|Standard Error of the Mean|7.07|||2-Sided|95.0|-10.22|17.03||||||ACR50 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.|
1600415|NCT02816138|2940520|Other|||||||0.049|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test|||
1600365|NCT02819726|2940343|Other||Difference (%)|9.5|Standard Error of the Mean|6.87|||2-Sided|95.0|-4.07|22.46||||||ACR20 Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method. The adjusted difference and its 95% confidence intervals are from a logistic regression model containing treatment group as a factor and baseline DAS28-CRP value as a covariate.|
1600366|NCT02819726|2940344|Other||Difference (%)|-11.8|Standard Error of the Mean|7.26|||2-Sided|95.0|-25.47|2.45||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.|
1600367|NCT02819726|2940344|Other||Difference (%)|-2.5|Standard Error of the Mean|7.05|||2-Sided|95.0|-15.95|11.22||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.|
1600368|NCT02819726|2940344|Other||Difference (%)|9.4|Standard Error of the Mean|7.22|||2-Sided|95.0|-4.74|23.03||||||Week 52 (EOS) assessment. The 95% CIs for ACR response rate and difference were derived using the Wilson Score method.|
1600369|NCT02819726|2940345|Other||LS Means Difference|0.18|Standard Error of the Mean|0.175||0.3053|2-Sided|95.0|-0.165|0.532|||ANCOVA|||Week 53 (EOS) MabThera vs Rituxan. Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.|
1600370|NCT02819726|2940345|Other||LS Means Difference|0.09|Standard Error of the Mean|0.172||0.599|2-Sided|95.0|-0.249|0.43|||ANCOVA|||Week 52 (EOS) Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.|
1600371|NCT02819726|2940345|Other||LS Means Difference|-0.09|Standard Error of the Mean|0.172||0.6068|2-Sided|95.0|-0.428|0.25|||ANCOVA|||Week 52 (EOS). Least square means and confidence intervals were estimated from an ANCOVA model containing treatment group as a factor and Baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only.|
1600372|NCT02819726|2940354|Equivalence|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of [-0.6,0.6]|LS Means Difference|-0.04|Standard Error of the Mean|0.137||0.7429|2-Sided|95.0|-0.314|0.224|||ANCOVA|||Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only|
1600373|NCT02819726|2940354|Equivalence|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of [-0.6,0.6]|LS Means Difference|-0.2|Standard Error of the Mean|0.135||0.1346|2-Sided|95.0|-0.469|0.063|||ANCOVA|||Least square means and CIs were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only|
1600374|NCT02819726|2940354|Equivalence|The equivalence between 2 study treatments would be declared if the two-sided 95% CI of the difference in change from baseline in DAS28-CRP at week 24 in entirely contained within the equivalence margin of [-0.6,0.6]|LS Mean Difference|-0.16|Standard Error of the Mean|0.134||0.2402|2-Sided|95.0|-0.422|0.106|||ANCOVA|||Least square means and confidence intervals (CIs) were estimated from an ANCOVA model containing treatment group as a factor and baseline DAS28-CRP value as a covariate. ANCOVA model contains treatment group only|
1600375|NCT02819726|2940355|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|115.13|||||2-Sided|90.0|99.51|133.21||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment|
1600376|NCT02819726|2940355|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|102.56|||||2-Sided|90.0|88.72|118.56||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment|
1600377|NCT02819726|2940355|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|89.08|||||2-Sided|90.0|77.2|102.79||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment|
1600378|NCT02819726|2940356|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|104.03|||||2-Sided|90.0|97.54|110.95||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment|
1600379|NCT02819726|2940356|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.75|||||2-Sided|90.0|92.61|105.3||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment|
1600380|NCT02819726|2940356|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|94.93|||||2-Sided|90.0|89.03|101.23||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment|
1600381|NCT02819726|2940357|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|102.43|||||2-Sided|90.0|96.14|109.14||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment|
1600382|NCT02819726|2940357|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.65|||||2-Sided|90.0|92.64|105.05||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment|
1600383|NCT02819726|2940357|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|96.31|||||2-Sided|90.0|90.52|102.46||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment|
1600416|NCT02816138|2940521|Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test|||
1600417|NCT02816138|2940522|Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed-rank test|||
1600384|NCT02819726|2940358|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|100.35|||||2-Sided|90.0|92.68|108.65||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment|
1600385|NCT02819726|2940358|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ration|94.39|||||2-Sided|90.0|87.21|102.16||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment|
1600386|NCT02819726|2940358|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|94.07|||||2-Sided|90.0|86.91|101.81||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment|
1600387|NCT02819726|2940359|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|98.06|||||2-Sided|90.0|89.49|107.45||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment|
1600388|NCT02819726|2940359|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ratio|93.43|||||2-Sided|90.0|85.54|102.15||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance (ANOVA) model with fixed effect for treatment|
1600389|NCT02819726|2940359|Equivalence|Standard acceptance limits for bioequivalence (80.00% to 125.00%) for all treatment comparisons|GLS Mean Ration|95.33|||||2-Sided|90.0|87.07|104.37||||||The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model (ANOVA) with fixed effect for treatment|
1600390|NCT02819011|2940360|Superiority|||||||0.829||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months|
1600391|NCT02819011|2940361|Superiority|||||||0.857||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months|
1600392|NCT02819011|2940362|Superiority|||||||0.769||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months|
1600393|NCT02819011|2940365|Superiority|||||||0.756||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months|
1600394|NCT02819011|2940366|Superiority|||||||0.65||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes between groups from baseline to 6 months|
1600395|NCT02819011|2940367|Superiority|||||||0.572||||||priori threshold for statistical significance = 0.05|Generalized Estimating Equations|||Repeated measures to compare the changes of both groups from pre-intervention to post-intervention year.|
1600396|NCT02819011|2940369|Superiority|||||||0.019||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes in both groups from baseline to 6 months|
1600397|NCT02819011|2940370|Superiority|||||||0.005||||||a priori threshold for statistical significance = 0.05|Mixed Models Analysis|||Repeated measures to compare the changes in both groups from baseline to 6 months|
1600398|NCT02819011|2940371|Superiority|||||||0.04||||||priori threshold for statistical significance= 0.05|Mixed Models Analysis|||Repeated measures to compare changes in two groups from baseline to 6 months|
1600399|NCT02818998|2940377|Other||Treatment Difference|-0.68|||||2-Sided|95.0|-2.0|0.65||||||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm|
1600400|NCT02818998|2940377|Other||Treatment Difference|1.72|||||2-Sided|95.0|-4.1|7.54||||||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm|
1600401|NCT02818998|2940377|Other||Treatment Difference|-0.13|||||2-Sided|95.0|-3.68|3.41||||||≥15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm|
1600402|NCT02818998|2940377|Other||Treatment Difference|-0.66|||||2-Sided|95.0|-1.94|0.63||||||≥30 letter loss: Aflibercept 2 mg fixed was regarded as the reference arm|
1600403|NCT02818998|2940377|Other||Treatment Difference|2.66|||||2-Sided|95.0|-3.4|8.73||||||≥10 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm|
1600404|NCT02818998|2940377|Other||Treatment Difference|0.68|||||2-Sided|95.0|-3.14|4.49||||||≥ 15 letter gain: Aflibercept 2 mg fixed was regarded as the reference arm|
1600405|NCT02818998|2940378|Other||Least Square mean difference|21.22||||0.0023|2-Sided|95.0|7.65|34.8|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm|
1600406|NCT02818998|2940378|Other||Least Square mean difference|14.38||||0.0105|2-Sided|95.0|3.39|25.37|||ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm|
1600407|NCT02818998|2940379|Non-Inferiority|Non-inferiority margin: 4 letters|Least Squares mean difference|0.95|||<|0.0001|2-Sided|95.0|-0.52|2.42||p-values adjusted for multiplicity by Hochberg procedure|ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm|
1600408|NCT02818998|2940379|Non-Inferiority|Non-inferiority margin: 4 letters|Least Squares mean difference|0.01|||<|0.0001|2-Sided|95.0|-1.46|1.47||p-values adjusted for multiplicity by Hochberg procedure|ANCOVA|||Aflibercept 2 mg fixed was regarded as the reference arm|
1600409|NCT02818114|2940425|Other|Assessment of number of PE sessions attended, review of direction of change in PTSD Checklist scores||||||||||||||||This is a single-arm feasibility study. With N=8, formal hypothesis testing is not possible. We were assessing the extent to which veterans would be willing to engage in the intervention, and if the direction of change in symptoms is still in the expected direction when peer support services are added. Outcomes are reported more qualitatively.|As a feasibility trial, tests of statistical significance are not appropriate.
1600410|NCT02818036|2940427|Other|differences in feelings of social connection between those who took naltrexone and those who took placebo||||||0.338||||||a priori threshold for statistical significance was p<.05|t-test, 2 sided||||
1600411|NCT02818036|2940428|Other|difference in neural activity to social task when taking naltrexone as compared to placebo|||||<|0.01||||||a priori threshold for significance was p<.05|t-test, 1 sided|degrees of freedom = 75|||
1669890|NCT01387815|3072820|Other|||||||0.752|||||||t-test, 2 sided||||
1600423|NCT02815982|2940528|Superiority||Mean Difference (Final Values)|0.01|||<|0.001|2-Sided|95.0|-0.04|0.06||threshold p < .05|t-test, 2 sided|||We compared Post-intervention scores|
1600424|NCT02815982|2940529|Superiority||Mean Difference (Final Values)|-2.85|||<|0.001|2-Sided|95.0|-11.3|5.65||threshold set at p < .05|t-test, 2 sided|||We compared Post-intervention scores|
1600425|NCT02815982|2940530|Superiority||Mean Difference (Final Values)|0.06|||<|0.0001|2-Sided|95.0|0.01|0.11||threshold set at p < .05|t-test, 2 sided|||We compared Post-intervention scores|
1600426|NCT02815982|2940531|Superiority||Mean Difference (Final Values)|-328.6|||<|0.08|2-Sided|95.0|-2868.4|2211.2||p < .05 threshold,|t-test, 2 sided|||We compared Post-intervention scores|
1600427|NCT02815982|2940532|Superiority||Mean Difference (Final Values)|3.5|||<|0.09|2-Sided|95.0|-4.3|11.3||p < .05 was threshold|t-test, 2 sided||||
1600428|NCT02815982|2940533|Superiority||Mean Difference (Final Values)|-0.12|||<|0.03|2-Sided|95.0|-5.4|5.2||p < .05 was the threshold|t-test, 2 sided|||We compared Post-intervention scores|
1600429|NCT02815982|2940534|Superiority||Mean Difference (Final Values)|0.47|||<|0.001|2-Sided|95.0|-2.3|3.3||controlling for caregiver BMI at baseline and PCS BMI percentile at baseline|t-test, 2 sided|||We compared Post-intervention BMI|
1600430|NCT02815982|2940535|Superiority||Mean Difference (Final Values)|35.6|||<|0.001|2-Sided|95.0|-559.0|630.2||p value was the actual signficance level|t-test, 2 sided|||We compared Post-intervention scores|
1600431|NCT02815982|2940536|Superiority||Mean Difference (Final Values)|-8.7|||<|0.05|2-Sided|95.0|-14.6|-2.7|||t-test, 2 sided||||
1600432|NCT02815644|2940547|Superiority or Other||T/R Ratio|82.19|Standard Error of the Mean|1.028|||2-Sided|90.0|78.38|86.18|||||Standard Error of the mean is actually geometric Standard Error of the mean|Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: “sequence”, “subjects within sequences”, “period”, and “treatment” (i.e., feeding status). The effect “subjects within sequences” was considered as random, whereas the other effects were considered as fixed.|
1600433|NCT02815644|2940548|Superiority or Other||T/R ratio|86.33|Standard Error of the Mean|1.019|||2-Sided|90.0|83.61|89.13|||||Standard Error of the mean is actually geometric Standard Error of the mean|Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: “sequence”, “subjects within sequences”, “period”, and “treatment” (i.e., feeding status). The effect “subjects within sequences” was considered as random, whereas the other effects were considered as fixed.|
1600434|NCT02815644|2940549|Superiority or Other||T/R ratio|88.13|Standard Error of the Mean|1.051|||2-Sided|90.0|80.89|96.03|||||Standard Error of the mean is actually geometric Standard Error of the mean|Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: “sequence”, “subjects within sequences”, “period”, and “treatment” (i.e., feeding status). The effect “subjects within sequences” was considered as random, whereas the other effects were considered as fixed.|
1600435|NCT02815644|2940550|Superiority or Other||T/R ratio|85.99|Standard Error of the Mean|1.018|||2-Sided|90.0|83.38|88.68|||||Standard Error of the mean is actually geometric Standard Error of the mean|Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: “sequence”, “subjects within sequences”, “period”, and “treatment” (i.e., feeding status). The effect “subjects within sequences” was considered as random, whereas the other effects were considered as fixed.|
1600436|NCT02815644|2940551|Superiority or Other||T/R ratio|82.19|Standard Error of the Mean|1.028|||2-Sided|90.0|78.38|86.18|||||Standard Error of the mean is actually geometric Standard Error of the mean|Relative bioavailability of linagliptin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: “sequence”, “subjects within sequences”, “period”, and “treatment” (i.e., feeding status). The effect “subjects within sequences” was considered as random, whereas the other effects were considered as fixed.|
1600437|NCT02815644|2940552|Superiority or Other||T/R ratio|74.89|Standard Error of the Mean|1.073|||2-Sided|90.0|66.27|84.64|||||Standard Error of the mean is actually geometric Standard Error of the mean|Relative bioavailability of empagliflozin was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: “sequence”, “subjects within sequences”, “period”, and “treatment” (i.e., feeding status). The effect “subjects within sequences” was considered as random, whereas the other effects were considered as fixed.|
1600438|NCT02815644|2940553|Superiority or Other||T/R ratio|55.69|Standard Error of the Mean|1.087|||2-Sided|90.0|48.22|64.33|||||Standard Error of the mean is actually geometric Standard Error of the mean.|Relative bioavailability of linagliptin after food intake compared to while in the fasting state was assessed using an ANOVA on the basis of the log transformed PK parameters. This model for the evaluation of effect of food on bioavailability included the effects: “sequence”, “subjects within sequences”, “period”, and “treatment” (i.e., feeding status). The effect “subjects within sequences” was considered as random, whereas the other effects were considered as fixed.|
1600439|NCT02814643|2940590|Other||Geometric least-square mean ratio|1.26||||||90.0|0.93|1.7||||||Influenza B Victoria lineage|
1600440|NCT02814643|2940590|Other||Geometric least-square mean ratio|1.03||||||90.0|0.79|1.34||||||Influenza B Yamagata lineage|
1600441|NCT02814643|2940590|Other||Geometric least-square mean ratio|1.28|||||2-Sided|90.0|0.93|1.77||||||Influenza A H3N2|
1600442|NCT02814643|2940590|Other||Geometric least-square mean ratio|1.0|||||2-Sided|90.0|0.76|1.31||||||Influenza A H1N1|
1600443|NCT02814643|2940591|Other||Geometric least-square mean ratio|0.8|||||2-Sided|90.0|0.54|1.19||||||Influenza B Victoria lineage|
1600444|NCT02814643|2940591|Other||Geometric least-square mean ratio|0.93|||||2-Sided|90.0|0.67|1.29||||||Influenza B Yamagata lineage|
1600445|NCT02814643|2940591|Other||Geometric least-square mean ratio|1.19|||||2-Sided|90.0|0.82|1.71||||||Influenza A H3N2|
1600446|NCT02814643|2940591|Other||Geometric least-square mean ratio|0.87|||||2-Sided|90.0|0.56|1.35||||||Influenza A H1N1|
1600447|NCT02814565|2940592|Superiority|||||||0.2371|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600448|NCT02814565|2940592|Superiority|||||||0.0749|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600449|NCT02814565|2940592|Superiority|||||||0.692|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600450|NCT02814565|2940593|Superiority|||||||0.2542|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600451|NCT02814565|2940593|Superiority|||||||0.088|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600452|NCT02814565|2940593|Superiority|||||||0.5275|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600453|NCT02814565|2940594|Superiority|||||||0.0489|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600454|NCT02814565|2940594|Superiority|||||||0.1163|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600455|NCT02814565|2940594|Superiority|||||||0.4428|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600456|NCT02814565|2940595|Superiority|||||||0.025|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600457|NCT02814565|2940595|Superiority|||||||0.2367|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600458|NCT02814565|2940595|Superiority|||||||0.302|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600459|NCT02814565|2940596|Superiority|||||||0.2757|||||||Fisher Exact|||"Day 14. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."|
1600460|NCT02814565|2940596|Superiority|||||||1|||||||Fisher Exact|||"Day 7. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."|
1600461|NCT02814565|2940596|Superiority|||||||1|||||||Fisher Exact|||"Day 3. A two-tailed Fisher's exact test to compare the number of responders between the Placebo and the Cyclobenzaprine HCl 15 mg treatment group to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance."|
1600462|NCT02814565|2940597|Superiority|||||||0.0905|||||||Wilcoxon Sum Rank Test|||Day 14. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600463|NCT02814565|2940597|Superiority|||||||0.4395|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600464|NCT02814565|2940597|Superiority|||||||0.5756|||||||Wilcoxon Sum Rank Test|||Day 3. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600465|NCT02814565|2940598|Superiority|||||||0.0262|||||||Wilcoxon Sum Rank Test|||Day 15. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600466|NCT02814565|2940598|Superiority|||||||0.033|||||||Wilcoxon Sum Rank Test|||Day 7. The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600467|NCT02814565|2940599|Superiority|||||||0.0393|||||||Wilcoxon Sum Rank Test|||The 2-sample Wilcoxon sum rank test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600468|NCT02814565|2940600|Superiority|||||||0.1657|||||||Wilcoxon Rank Sum Test|||Day 14. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600469|NCT02814565|2940600|Superiority|||||||0.4338|||||||Wilcoxon Rank Sum Test|||Day 7. The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1600470|NCT02814565|2940601|Superiority|||||||0.6179|||||||Wilcoxon Rank Sum test|||The 2-sample Wilcoxon rank sum test was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 0.05 level of significance.|
1602239|NCT02756689|2943619|Superiority|||||||0.75|||||||Wilcoxon (Mann-Whitney)||||
1600471|NCT02813694|2940610|Non-Inferiority|non-inferiority margin = 10%|Treatment difference|-3.9|||||2-Sided|95.0|-8.4|0.7|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic.||
1600472|NCT02813694|2940610|Non-Inferiority|non-inferiority margain = 10%|Treatment difference|-3.9|||||2-Sided|95.0|-8.2|0.5|||||Difference in percentage of success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use [Y vs. N]; PORT risk class [III vs. IV/V], using CMH stratum weights.||
1600473|NCT02813694|2940611|Non-Inferiority|non-inferiority margain = 10%|Treatment difference|-1.6|||||2-Sided|95.0|-6.5|3.3|||||Difference in percentage of Success for IACR at test of cure visit. Confidence interval computed using a continuity-corrected Z-test.||
1600474|NCT02813694|2940611|Non-Inferiority|non-inferiority margin = 10%|Treatment difference|-1.6|||||2-Sided|95.0|-6.3|3.1|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use [Y vs. N] and PORT risk class [III vs. IV/V], using CMH stratum weights.||
1600475|NCT02813694|2940612|Non-Inferiority|non-inferiority margin= 10%|Treatment difference|0.1|||||2-Sided|95.0|-4.4|4.5|||||Difference in percentage of Responders for ECR (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic||
1600476|NCT02813551|2940636|Superiority||Risk Ratio (RR)|0.4|||||2-Sided|95.0|0.1|2.9|||||||
1600477|NCT02813551|2940637|Superiority||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.5|1.9|||||||
1600478|NCT02813551|2940638|Superiority||Risk Ratio (RR)|1.1|||||2-Sided|95.0|1.0|1.2|||||||
1600479|NCT02813551|2940641|Superiority||Risk Ratio (RR)|1.1|||||2-Sided|95.0|1.0|1.3|||||||
1600480|NCT02813551|2940642|Superiority||Risk Ratio (RR)|3.0|||||2-Sided|95.0|0.3|28.0|||||||
1600481|NCT02813551|2940643|Superiority||Risk Ratio (RR)|1.2|||||2-Sided|95.0|0.4|3.3|||||||
1600482|NCT02813551|2940644|Superiority||Risk Ratio (RR)|0.76|||||2-Sided|95.0|0.53|1.1|||||||
1600483|NCT02812186|2940662|Superiority|||||||0.63|||||||Wilcoxon (Mann-Whitney)||||
1600484|NCT02812186|2940663|Superiority|||||||0.28|||||||Wilcoxon (Mann-Whitney)||||
1600485|NCT02812186|2940664|Superiority|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1600486|NCT02811965|2940665|Superiority|||||||5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600487|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600488|NCT02811965|2940665|Superiority||||||<|0.084||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600489|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600490|NCT02811965|2940665|Superiority||||||<|0.0044|||||||t-test, 2 sided||||
1600491|NCT02811965|2940665|Superiority||||||<|0.092||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600492|NCT02811965|2940665|Superiority||||||<|0.53||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600493|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600494|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600495|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600496|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600497|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600498|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600499|NCT02811965|2940665|Superiority||||||<|0.0011||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600500|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600501|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600502|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600503|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600504|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600505|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600506|NCT02811965|2940665|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600507|NCT02811965|2940665|Superiority||||||<|5e-05||||||A priori threshold p<0.05.|Repeated Measures ANOVA||||
1600508|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600509|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600510|NCT02811965|2940666|Superiority||||||<|0.14||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600511|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600512|NCT02811965|2940666|Superiority||||||<|0.0093||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600513|NCT02811965|2940666|Superiority||||||<|0.14||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600514|NCT02811965|2940666|Superiority||||||<|0.24||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600515|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600516|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600517|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600518|NCT02811965|2940666|Superiority||||||<|5e-05|||||||t-test, 2 sided||||
1600519|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600520|NCT02811965|2940666|Superiority||||||<|0.0002||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600521|NCT02811965|2940666|Superiority||||||<|0.01||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600522|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600523|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600524|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600525|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600526|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600527|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600528|NCT02811965|2940666|Superiority||||||<|5e-05||||||P-value adjusted with Holm-Bonferroni Correction for multiple comparison. A priori threshold p<0.05.|t-test, 2 sided||||
1600529|NCT02811965|2940666|Superiority||||||<|5e-05||||||A priori threshold p < 0.05|Repeated Measures ANOVA||||
1600530|NCT02811302|2940669|Other|Multivariable model for (Multivariate logistic regression) Respiratory Depression, followed by validation with Harrell's Optimism using a bootstrap sampling method.|Area Under the Curve|0.76|||||2-Sided|95.0|0.73|0.79|||||The model was performed using stepwise selection including all potential predictors and interactions terms (medical history and baseline characteristics).|A modified Full Analysis Dataset (1335) was used to derive and validate the risk assessment tool. Subjects were excluded if they had major deviations or consent withdrawals. Subjects that did not have any monitoring data were also excluded. Finally, 69 subjects were further excluded from the model, as they were missing parameters to calculate their risk score.|The model derived from the logistic regression was assessed by the Hosmer-Lemshow goodness of fit test (P = 0.831). The derived model was validated by Harrell’s Optimism using a Bootstrap sampling method (500 samples from the modified dataset, 1335) with replacement. The logistic regression model with stepwise selection was performed for each bootstrap sample, and AUC calculated. The optimism calculated by Harrell’s algorithm was 0.02. The model was then checked for the quartiles of the effective monitoring and for geography used as a random effect. The performance measurement of the final model was adjusted according the Harrell’s Optimism for a final adjusted AUC of 0.74.
1600531|NCT02811302|2940670|Other|A simple count and percentage of the population were calculated based on the number of patients adjudicated as having Respiratory Depression.|||||||||||||||||To determine the risk assessment score, first the number of patients with Respiratory Depression (RD) had to be identified. Per the rules established for the Clinical Endpoint Committee, 655 (43.6%) patients were identified as having RD.
1600532|NCT02811159|2940672|Other|||||||0.0645|||||||Wilcoxon Signed-Rank Test||||
1600533|NCT02811159|2940673|Other|||||||0.25|||||||Wilcoxon Signed-Rank Test||||
1600534|NCT02811159|2940674|Other|||||||0.5|||||||Wilcoxon Signed-Rank Test||||
1600535|NCT02811159|2940675|Other|||||||0.5|||||||Wilcoxon Signed-Rank Test||||
1600536|NCT02811159|2940676|Other|||||||0.875|||||||Wilcoxon Signed-Rank Test||||
1600537|NCT02811159|2940677|Other|||||||1|||||||Wilcoxon Signed-Rank Test||||
1600538|NCT02811159|2940678|Other|||||||0.25|||||||Wilcoxon Signed-Rank Test||||
1600539|NCT02811159|2940679|Other|||||||0.5|||||||Wilcoxon Signed-Rank Test||||
1600540|NCT02811159|2940680|Other|||||||0.25|||||||Wilcoxon Signed-Rank Test||||
1600541|NCT02811159|2940681|Other|||||||0.125|||||||Wilcoxon Signed-Rank Test||||
1600542|NCT02811159|2940682|Other|||||||0.1797|||||||Chi-Square Test||||
1600543|NCT02810457|2940697|Other|Comparison between arms: Odds ratio.|Odds Ratio (OR)|1.01|||||2-Sided|95.0|0.64|1.58|||||Odds ratio >1 favors FKB238.|The DCR was compared between treatment arms using logistic regression adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age).|
1600544|NCT02810457|2940698|Other|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.74|1.23|||||Treatment hazard ratio <1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.|
1600996|NCT02799472|2941110|Other||Ratio|0.763||||0.129|2-Sided|95.0|0.536|1.087|||Repeated measures analysis|||CD16+CD56+, Week 12|
1600545|NCT02810457|2940699|Other|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|1.18|||||2-Sided|95.0|0.96|1.45|||||Treatment hazard ratio <1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, ECOG performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.|
1600546|NCT02810457|2940700|Other|Hazard ratio analysis of FKB238 versus Avastin.|Hazard Ratio (HR)|0.97|||||2-Sided|95.0|0.82|1.16|||||Treatment hazard ratio <1 favors FKB238.|Hazard ratio and its 95% CI were calculated using the Cox regression model adjusting for baseline characteristics (randomization stratification factors, Eastern Cooperative Oncology Group (ECOG) performance status at baseline, gender, smoking history and age) with ties handled by the Efron method.|
1600547|NCT02810457|2940701|Other|Ratio in ORR analysis of FKB238 versus Avastin.|Ratio in ORR|0.94|||||2-Sided|90.0|0.83|1.06||||||Comparison between groups: Risk ratio in ORR at Week 19 by BICR.|
1600548|NCT02810457|2940702|Equivalence|A 90% CI for the ORR ratio between FKB238 and Avastin was estimated and compared to the margin (0.73 to 1.38), which was deemed to represent a clinically acceptable difference with respect to ORR. If the 90% CI was within the equivalence margin (0.73 to 1.38), an equivalence between FKB238 and Avastin, with respect to the ORR, was confirmed.|Ratio in ORR|0.96|||||2-Sided|90.0|0.86|1.08|||||||
1600549|NCT02810327|2940703|Other|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||The MUSC Bioinformatics Core analyzed group genomic data for variant association with COPD severity score, including single variant association or type of variant association with symptoms. Descriptive statistical analysis was performed using statistical package SAS 9.4 for Windows (SAS Institute Inc., Cary, NC, USA).|
1600550|NCT02809846|2940711|Other|Bivariate associations between variables were assessed using statistical methods appropriate for the variable types. Baseline characteristics (demographics, other morbidities, baseline medication use, pain intensity and QOL) were compared between the two treatment groups to assess effectiveness of randomization and identify important covariates for multivariable analyses. Associations between demographic variables and primary and secondary endpoints were examined.|||||<|0.05||||||Sensitivity analyses comparing use of data from all participants with use of participants with complete data only was also performed. Agreement between different measures representing the same variable type was assessed using correlation analyses.|Mixed Models Analysis|Multivariable analysis with mixed effect regression models were used to assess the effect of treatment group on the primary and secondary outcomes.||Initially, a sample size of 20 participants per treatment group (active and sham) was selected to achieve 90% power to find a 20% difference in mean percent change in opioid consumption between the two groups with an estimated standard deviation of 22% and 80% power to detect the same difference with a standard deviation of 19% at a two-sided alpha = 0.05|Similar models were used to assess associations of treatment group with secondary endpoints. Model fit was assessed by Akaike’s Information Criteria to determine optimal covariance structure.
1600551|NCT02809183|2940783|Other|Two-group test||||||0.0003||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by => 4 mEq/L = 0.|Fisher Exact||||
1600552|NCT02809183|2940783|Other|Two-group test||||||0.0003||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by => 3 mEq/L = 0.|Fisher Exact||||
1600553|NCT02809183|2940783|Other|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by => 2 mEq/L = 0.|Fisher Exact||||
1600554|NCT02809183|2940784|Other|Two-group test|Difference between group LS means|-0.5|Standard Error of the Mean|0.6||0.4214|2-Sided|95.0|-1.6|0.7||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - 6g TRC101 QD) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis||||
1600555|NCT02809183|2940785|Other|Two-group test|Difference between group LS means|3.7|Standard Error of the Mean|0.5|<|0.0001|2-Sided|95.0|2.6|4.7||The null hypothesis is the difference between treatment groups (6g TRC101 QD - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis||||
1600556|NCT02809183|2940786|Other|Single-group test|Group LS mean|3.5|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|2.7|4.2||The null hypothesis is that the mean change from baseline within the 6g TRC101 QD group = 0 mEq/L.|Mixed Models Analysis||||
1600557|NCT02809183|2940787|Other|Two-group test|||||<|0.0006||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by => 4 mEq/L = 0.|Fisher Exact||||
1600558|NCT02809183|2940787|Other|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by => 3 mEq/L = 0.|Fisher Exact||||
1600559|NCT02809183|2940787|Other|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (4.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by => 2 mEq/L = 0.|Fisher Exact||||
1600560|NCT02809183|2940787|Other|Two-group test|||||<|0.0013||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by => 4 mEq/L = 0.|Fisher Exact||||
1600561|NCT02809183|2940787|Other|Two-group test|||||<|0.0032||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by => 3 mEq/L = 0.|Fisher Exact||||
1600562|NCT02809183|2940787|Other|Two-group test|||||<|0.0012||||||The null hypothesis is that the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by => 2 mEq/L = 0.|Fisher Exact||||
1600563|NCT02809183|2940787|Other|Two-group test|||||<|0.0074||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by => 4 mEq/L = 0.|Fisher Exact||||
1600907|NCT02799472|2941105|Other||Mean Difference (Net)|-63419.4||||0.232|2-Sided|95.0|-170364.9|43526.1|||Repeated measures analysis|||CD14br+CD16-, 12-Week FU|
1600564|NCT02809183|2940787|Other|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by => 3 mEq/L = 0.|Fisher Exact||||
1600565|NCT02809183|2940787|Other|Two-group test|||||<|0.0001||||||The null hypothesis is that the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in proportion of subjects whose serum bicarbonate increased from baseline to Day 15 by => 2 mEq/L = 0.|Fisher Exact||||
1600566|NCT02809183|2940788|Other|Two-group test|Difference between group LS means|3.6|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|2.8|4.4||The null hypothesis is that the difference between treatment groups (Combined TRC101 - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis||||
1600567|NCT02809183|2940789|Other|Single-group test|Group LS mean|3.3|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|3.0|3.7||The null hypothesis is that the mean change from baseline within the Combined TRC101 treatment group = 0 mEq/L.|Mixed Models Analysis||||
1600568|NCT02809183|2940790|Other|Two-group test|Difference between group LS means|3.9|Standard Error of the Mean|0.5|<|0.0001|2-Sided|95.0|2.9|5.0||The null hypothesis is the difference between the treatment groups (4.5g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis||||
1600569|NCT02809183|2940790|Other|Two-group test|Difference between group LS means|3.2|Standard Error of the Mean|0.5|<|0.0001|2-Sided|95.0|2.2|4.3||The null hypothesis is the difference between treatment groups (3g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis||||
1600570|NCT02809183|2940790|Other|Two-group test|Difference between group LS means|3.4|Standard Error of the Mean|0.5|<|0.0001|2-Sided|95.0|2.3|4.5||The null hypothesis is the difference between treatment groups (1.5g TRC101 BID - Pooled Placebo) in the mean change from baseline = 0 mEq/L.|Mixed Models Analysis||||
1600571|NCT02809183|2940791|Other|Single-group test|Group LS mean|3.7|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|2.9|4.5||The null hypothesis is the 4.5g TRC101 BID treatment group mean change from baseline = 0 mEq/L|Mixed Models Analysis||||
1600572|NCT02809183|2940791|Other|Single-group test|Group LS mean|3.0|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|2.2|3.8||The null hypothesis is the 3g TRC101 BID treatment group mean change from baseline = 0 mEq/L.|Mixed Models Analysis||||
1600573|NCT02809183|2940791|Other|Single-group test|Group LS mean|3.2|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|2.4|4.0||The null hypothesis is that the mean change from baseline within the 1.5g TRC101 BID group = 0 mEq/L|Mixed Models Analysis|||The null hypothesis is that the mean change from baseline within the 1.5g TRC101 BID treatment group = 0 mEq/L.|
1600574|NCT02809183|2940791|Other|Single-group test|Group LS mean|-0.2|Standard Error of the Mean|0.4|<|0.5547|2-Sided|95.0|-0.9|0.5||The null hypothesis is that the mean change from baseline within the Pooled Placebo treatment group = 0 mEq/L.|Mixed Models Analysis||||
1600575|NCT02808975|2940793|Superiority||||||=|0|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.|||
1600576|NCT02808975|2940794|Superiority||||||=|0|||||||ANCOVA|Across all strata, P-values are calculated from ANCOVA with stratum, baseline value, and treatment in the model.|||
1600577|NCT02808975|2940795|Superiority||||||=|0|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.|||
1600578|NCT02808975|2940796|Superiority||||||=|0|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.|||
1600579|NCT02808975|2940797|Superiority||||||=|0|||||||Cochran-Mantel-Haenszel|Across all strata, P-value calculated from Cochran-Mantel-Haenszel test adjusted for strata. Stratum containing zero count: 0.1 added to each cell.|||
1600580|NCT02807259|2940829|Other||Odds Ratio (OR)|1.69||||0.042|2-Sided|95.0|1.02|2.82|||Mixed Models Analysis||||
1600581|NCT02807259|2940830|Other||Odds Ratio (OR)|0.96||||0.845|2-Sided|95.0|0.61|1.5|||Mixed Models Analysis||||
1600582|NCT02807259|2940831|Other||Odds Ratio (OR)|2.07||||0.372|2-Sided|95.0|0.42|10.26|||Mixed Models Analysis||||
1600583|NCT02807259|2940832|Other||Odds Ratio (OR)|0.62||||0.025|2-Sided|95.0|0.4|0.94|||Mixed Models Analysis||||
1600584|NCT02807259|2940833|Other||Odds Ratio (OR)|0.93||||0.748|2-Sided|95.0|0.58|1.47|||Mixed Models Analysis||||
1600585|NCT02807259|2940834|Other||Odds Ratio (OR)|1.38||||0.378|2-Sided|95.0|0.68|2.81|||Mixed Models Analysis||||
1600586|NCT02807259|2940835|Equivalence|Power calculations did not account for stratification used in the randomisation or include adjustment for baseline levels of the outcome, since the correlation over time was not known. Results suggested that the trial had >80% power to detect a risk ratio of 0.77, if the coefficient of between-cluster variation was between 0.15 and 0.25.|Odds Ratio (OR)|1.47||||0.298|2-Sided|95.0|0.71|3.01|||Mixed Models Analysis|||Power calculations were conducted assuming an IPV prevalence (past 12 months) of 47% and consistent condom use (past 12 months) of 38% based on initial assessments. The power calculation was performed by analysing simulated data from 800 women, distributed across clusters using empirical data with a range in variance across cluster-level proportions of IPV (15% to 25% of the total variation) and a narrow range of effect sizes (risk ratio= 0.75-0.80).|
1600587|NCT02806947|2940850|Superiority|||||||0.221||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with serious infections between the sirolimus and prednisone arms during the 12 month period post-randomization, with death treated as a competing risk for serious infection. These proportions were compared between treatment arms using Gray's test.|
1600588|NCT02806947|2940851|Superiority|||||||0.598||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with GVHD-free survival at 6 months post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.|
1600863|NCT02801877|2941062|Superiority|||||||0.3|||||||Log Rank|Chi square= 4.1 on 3 degrees of freedom||Log-rank test of adherence, defined as time to last engagement with mobile application suite.|
1600589|NCT02806947|2940851|Superiority|||||||0.936||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with GVHD-free survival at 6 months post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.|
1600590|NCT02806947|2940852|Superiority|||||||0.296||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with chronic GVHD between the sirolimus and prednisone arms during the 12 month period post-randomization, with death and malignancy relapse treated as competing risks for chronic GVHD. These proportions were compared between treatment arms using Gray's test.|
1600591|NCT02806947|2940853|Superiority|||||||0.402||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with malignancy relapse between the sirolimus and prednisone arms during the 12 month period post-randomization, with death treated as a competing risk for malignancy relapse. These proportions were compared between treatment arms using Gray's test.|
1600592|NCT02806947|2940854|Superiority|||||||0.726||||||Statistical significance was determined using a pre-specified threshold of 0.05|Gray's test|||The null hypothesis is that there is no difference in the proportions of participants with non-relapse mortality between the sirolimus and prednisone arms during the 12 month period post-randomization, with malignancy relapse treated as a competing risk for non-relapse mortality. These proportions were compared between treatment arms using Gray's test.|
1600593|NCT02806947|2940855|Superiority|||||||0.713||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with event-free survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.|
1600594|NCT02806947|2940856|Superiority|||||||0.34||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with disease-free survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.|
1600595|NCT02806947|2940857|Superiority|||||||0.785||||||Statistical significance was determined using a pre-specified threshold of 0.05|Log Rank|||The null hypothesis is that there is no difference in the proportions of participants with overall survival between the sirolimus and prednisone arms during the 12 month period post-randomization. These proportions were compared between treatment arms using a log rank test.|
1600596|NCT02806947|2940858|Superiority|||||||0.068||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with treatment failure at Day 56 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.|
1600597|NCT02806947|2940858|Superiority|||||||0.078||||||Statistical significance was determine using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with treatment failure at Day 28 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.|
1600598|NCT02806947|2940859|Superiority|||||||0.014||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in classification of acute GVHD response at Day 56 post-randomization between participants on the sirolimus and prednisone arms. These classifications were compared between treatment arms using Fisher's exact test, due to the presence of small numbers of participants in some categories.|
1600599|NCT02806947|2940859|Superiority|||||||0.32||||||Statistical significance was determined using a pre-specified threshold of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in classification of acute GVHD response at Day 28 post-randomization between participants on the sirolimus and prednisone arms. These classifications were compared between treatment arms using Fisher's exact test, due to the presence of small numbers of participants in some categories.|
1600600|NCT02806947|2940860|Superiority||||||<|0.001||||||Statistical significance was determined using a pre-specified threshold of 0.05|Z test comparing binomial proportions|||The null hypothesis is that there is no difference in the proportions of participants with CR/PR and steroid dose of 0.25mg/kg/day or less at Day 28 post-randomization between the sirolimus and prednisone arms. These proportions were compared between treatment arms using a Z test of the difference of binomial proportions.|
1600601|NCT02806947|2940861|Other|No formal hypothesis test was planned or performed for comparing Day 56 CR/PR proportions between arms. Rather, the risk difference is estimated by a point estimate and 95% confidence interval.|Risk Difference (RD)|-0.152|Standard Error of the Mean|0.083|||2-Sided|95.0|-0.315|0.011|||||The risk difference estimate is the observed proportion of Day 56 CR/PR in the sirolimus arm minus the proportion in the prednisone arm. A Wald confidence interval for this difference is given.|A secondary objective of this Phase II trial was to describe the proportion of patients with Day 56 CR/PR in each treatment arm and to estimate the risk difference of these rates using a point estimate and 95% confidence interval. These estimates are used to inform about the efficacy of sirolimus in contrast to prednisone for potential future research.|
1600602|NCT02806947|2940861|Other|No formal hypothesis test was planned or performed for comparing Day 28 CR/PR proportions between arms. Rather, the risk difference is estimated by a point estimate and 90% confidence interval.|Risk Difference (RD)|-0.082|Standard Error of the Mean|0.086|||2-Sided|90.0|-0.223|0.059|||||The risk difference estimate is the observed proportion of Day 28 CR/PR in the sirolimus arm minus the proportion in the prednisone arm. A Wald confidence interval for this difference is given.|The primary objective of this Phase II trial was to describe the proportion of patients with Day 28 CR/PR in each treatment arm and to estimate the risk difference of these rates using a point estimate and 90% confidence interval. These estimates are used to inform about the efficacy of sirolimus in contrast to prednisone for potential future research.|
1600908|NCT02799472|2941105|Other||Mean Difference (Net)|16182.9||||0.704|2-Sided|95.0|-70377.0|102742.9|||Repeated measures analysis|||CD14br+CD16-, Week 12|
1600603|NCT02806505|2940875|Superiority or Other||Odds Ratio (OR)|0.75||||0.5866|2-Sided|95.0|0.28|2.04||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||Week 24: The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.|
1600604|NCT02806505|2940875|Superiority or Other||Odds Ratio (OR)|1.07||||0.8843|2-Sided|95.0|0.43|2.68||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||Week 12: The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.|
1600605|NCT02806505|2940876|Superiority or Other||Odds Ratio (OR)|1.51||||0.3923|2-Sided|95.0|0.6|3.76||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.|
1600606|NCT02806505|2940877|Superiority or Other||Odds Ratio (OR)|1.22||||0.6746|2-Sided|95.0|0.49|3.06||Assessed by Cochran-Mantel-Haenszel test stratified by country (Brazil, France, Other) and HCV genotype (1 vs. non-1).|Cochran-Mantel-Haenszel|||The odds ratio is the ratio of the odds of a response in the Peginterferon alfa-2a 135 mcg group with the odds of a response in the Peginterferon alfa-2a 90 mcg group.|
1600607|NCT02804399|2940915|Superiority or Other||Ratio of Geometric Mean|13.96|||||2-Sided|90.0|12.09|16.12||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.|
1600608|NCT02804399|2940916|Superiority or Other||Ratio of Geometric Mean|23.88|||||2-Sided|90.0|21.58|26.43||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.|
1600609|NCT02804399|2940917|Superiority or Other||Ratio of Geometric Mean|14.74|||||2-Sided|90.0|12.78|17.01||||||Mixed model was fitted to obtain ratio of geometric means of Rifampin 600 mg QD + PF-06463922 100 mg SD (test) to PF-06463922 100 mg SD (reference) and the results are presented as percentage. 90% CI was calculated on ratio of geometric means.|
1600610|NCT02802878|2940975|Superiority|||||||0.67||||||Adjusted for two observations per subject.|Regression, Linear|Side treated as a repeated factor|||
1600611|NCT02802865|2940976|Superiority|||||||0.486|||||||Chi-squared, Corrected|||This study was not powered to detect significant between-group differences for pregnancy loss.|
1600612|NCT02802865|2940977|Superiority|||||||0.356|||||||Chi-squared|||This study was not powered to detect significant between-group differences for live birth.|
1600613|NCT02802865|2940979|Superiority|||||||0.356|||||||Chi-squared|||This study was not powered to detect significant between-group differences for clinical pregnancy.|
1600614|NCT02802865|2940980|Superiority|||||||0.709|||||||Chi-squared|||This study was not powered to detect significant between-group differences for this conception.|
1600615|NCT02802865|2940981|Superiority|||||||0.006|||||||t-test, 2 sided||||
1600616|NCT02802865|2940982|Superiority|||||||0.004|||||||Wilcoxon (Mann-Whitney)||||
1600617|NCT02802865|2940983|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1600618|NCT02802865|2940984|Superiority||Rate ratio|1.8||||0.007|2-Sided|95.0|1.18|2.75|||Chi-squared, Corrected||||
1600619|NCT02802345|2940995|Superiority||Percentage difference (%)|-5.37||||0.334|2-Sided|95.0|-16.25|5.52|||Cochran-Mantel-Haenszel||Within strata confidence limits are calculated according to Wald. Percentage difference = (% of Nintedanib+sildenafil) - (% of Nintedanib+placebo).|Risk difference, Comparison of treatment groups is calculated by Cochran−Mantel−Haenszel test adjusting for the categorical covariate presence of any echocardiographic signs indicative of right heart dysfunction (yes/no), adjusted Mantel−Haenszel type risk ratios and risk differences with 95% confidence are presented.|
1600620|NCT02802345|2940995|Superiority||Percentage ratio (%)|0.83|||||2-Sided|95.0|0.58|1.2|||||Within strata confidence limits are calculated according to Wald. Percentage ratio = (% of Nintedanib+sildenafil) / (% of Nintedanib+placebo).|Relative risk, Comparison of treatment groups is calculated by Cochran−Mantel−Haenszel test adjusting for the categorical covariate presence of any echocardiographic signs indicative of right heart dysfunction (yes/no), adjusted Mantel−Haenszel type risk ratios and risk differences with 95% confidence are presented.|
1600621|NCT02802345|2940996|Superiority||Adjusted mean difference|-2.41|Standard Error of the Mean|2.529||0.3421|2-Sided|95.0|-7.39|2.58|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 24 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline UCSD SOBQ total score as covariate, treatment−by−visit and baseline UCSD SOBQ total score−by−visit interaction terms using an unstructured covariance matrix. No imputation was planned.|
1600622|NCT02802345|2940997|Superiority||Adjusted mean difference|-2.19|Standard Error of the Mean|1.631||0.1809|2-Sided|95.0|-5.4|1.02|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 24 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline SGRQ total score as covariate, treatment−by−visit and baseline SGRQ total score−by−visit interaction terms using an unstructured covariance matrix. No imputation was planned.|
1600644|NCT02801942|2941014|Other||Mean Difference (Final Values)|-1.45|Standard Error of the Mean|4.736|||2-Sided|95.0|-11.49|8.58|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600645|NCT02801942|2941014|Other||Mean Difference (Final Values)|3.38|Standard Error of the Mean|1.337|||2-Sided|95.0|0.55|6.21|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600623|NCT02802345|2940998|Superiority||Adjusted mean difference|-2.94|Standard Error of the Mean|2.198||0.1823|2-Sided|95.0|-7.27|1.39|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 12 weeks)|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline UCSD SOBQ total score as covariate, treatment−by−visit and baseline UCSD SOBQ total score−by−visit interaction terms using an unstructured covariance matrix. No imputation was planned. Data collected after Visit 5 (planned 12 weeks after start of study treatment) were not used for this analysis.|
1600624|NCT02802345|2940999|Superiority||Adjusted mean difference|-0.52|Standard Error of the Mean|1.431||0.7191|2-Sided|95.0|-3.33|2.3|||Mixed Model for Repeated Measures (MMRM)|The Roger- Kenward approximation was used to estimate denominator degrees of freedom.|Adjusted mean difference (Nintedanib +placebo vs Nintedanib+sildenafil) is based on all analyzed patients in the model (not only patients with a measurement at baseline and at 12 weeks).|Mixed Model for Repeated Measures (MMRM) included fixed effects for treatment, visit, presence of any echocardiographic signs, baseline SGRQ total score as covariate, treatment−by−visit and baseline SGRQ total score−by−visit interaction terms using an unstructured covariance matrix. No imputation was planned. Data collected after Visit 5 (planned 12 weeks after start of study treatment) were not used for this analysis.|"H0: There is no difference in the mean change from baseline in SGRQ total score at Week 12 between treatment with nintedanib co-administered with sildenafil and treatment with nintedanib alone.~Ha: There is a difference in the mean change from baseline in SGRQ total score at Week 12 between treatment with nintedanib co-administered with sildenafil and treatment with nintedanib alone."
1600625|NCT02801942|2941012|Other||Mean Difference (Final Values)|1.58|Standard Error of the Mean|0.737|||2-Sided|95.0|0.03|3.13|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600626|NCT02801942|2941012|Other||Mean Difference (Final Values)|2.69|Standard Error of the Mean|1.019|||2-Sided|95.0|0.54|4.84|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600627|NCT02801942|2941012|Other||Mean Difference (Final Values)|1.24|Standard Error of the Mean|2.287|||2-Sided|95.0|-4.36|6.84|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600628|NCT02801942|2941012|Other||Mean Difference (Final Values)|1.33|Standard Error of the Mean|2.967|||2-Sided|95.0|-5.48|8.13|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600629|NCT02801942|2941012|Other||Mean Difference (Final Values)|-4.12|Standard Error of the Mean|3.947|||2-Sided|95.0|-12.67|4.43|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600630|NCT02801942|2941012|Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|6.712|||2-Sided|95.0|-14.49|14.48|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600631|NCT02801942|2941012|Other||Mean Difference (Final Values)|2.74|Standard Error of the Mean|2.109|||2-Sided|95.0|-1.68|7.17|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600632|NCT02801942|2941012|Other||Mean Difference (Final Values)|3.27|Standard Error of the Mean|1.37|||2-Sided|95.0|0.4|6.15|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600633|NCT02801942|2941013|Other||Mean Difference (Final Values)|2.27|Standard Error of the Mean|0.712|||2-Sided|95.0|0.75|3.79|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600634|NCT02801942|2941013|Other||Mean Difference (Final Values)|3.21|Standard Error of the Mean|1.205|||2-Sided|95.0|0.64|5.78|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600635|NCT02801942|2941013|Other||Mean Difference (Final Values)|0.41|Standard Error of the Mean|0.859|||2-Sided|95.0|-1.45|2.28|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600636|NCT02801942|2941013|Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|1.234|||2-Sided|95.0|-2.73|2.47|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600637|NCT02801942|2941013|Other||Mean Difference (Final Values)|-4.19|Standard Error of the Mean|4.862|||2-Sided|95.0|-14.71|6.33|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600638|NCT02801942|2941013|Other||Mean Difference (Final Values)|-0.91|Standard Error of the Mean|6.389|||2-Sided|95.0|-14.66|12.85|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600639|NCT02801942|2941013|Other||Mean Difference (Final Values)|2.19|Standard Error of the Mean|1.324|||2-Sided|95.0|-0.61|4.98|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600640|NCT02801942|2941013|Other||Mean Difference (Final Values)|1.38|Standard Error of the Mean|0.696|||2-Sided|95.0|-0.08|2.83|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600641|NCT02801942|2941014|Other||Mean Difference (Final Values)|6.17|Standard Error of the Mean|4.913|||2-Sided|95.0|-4.24|16.59|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600642|NCT02801942|2941014|Other||Mean Difference (Final Values)|10.45|Standard Error of the Mean|5.79|||2-Sided|95.0|-2.01|22.92|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600643|NCT02801942|2941014|Other||Mean Difference (Final Values)|1.88|Standard Error of the Mean|4.142|||2-Sided|95.0|-6.81|10.58|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600646|NCT02801942|2941014|Other||Mean Difference (Final Values)|3.22|Standard Error of the Mean|2.781|||2-Sided|95.0|-2.67|9.12|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600647|NCT02801942|2941014|Other||Mean Difference (Final Values)|2.57|Standard Error of the Mean|2.937|||2-Sided|95.0|-3.84|8.98|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600648|NCT02801942|2941014|Other||Mean Difference (Final Values)|1.65|Standard Error of the Mean|2.48|||2-Sided|95.0|-3.54|6.84|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600649|NCT02801942|2941014|Other||Mean Difference (Final Values)|-5.89|Standard Error of the Mean|3.855|||2-Sided|95.0|-14.14|2.37|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600650|NCT02801942|2941014|Other||Mean Difference (Final Values)|-11.19|Standard Error of the Mean|5.812|||2-Sided|95.0|-23.48|1.11|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600651|NCT02801942|2941014|Other||Mean Difference (Final Values)|8.21|Standard Error of the Mean|6.78|||2-Sided|95.0|-6.15|22.57|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600652|NCT02801942|2941014|Other||Mean Difference (Final Values)|4.86|Standard Error of the Mean|3.083|||2-Sided|95.0|-1.6|11.31|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600653|NCT02801942|2941015|Other||Mean Difference (Final Values)|2.91|Standard Error of the Mean|1.291|||2-Sided|95.0|-0.05|5.88|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600654|NCT02801942|2941015|Other||Mean Difference (Final Values)|1.48|Standard Error of the Mean|1.374|||2-Sided|95.0|-1.62|4.59|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600655|NCT02801942|2941015|Other||Mean Difference (Final Values)|-4.38|Standard Error of the Mean|5.301|||2-Sided|95.0|-15.85|7.1|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600656|NCT02801942|2941015|Other||Mean Difference (Final Values)|-1.16|Standard Error of the Mean|5.069|||2-Sided|95.0|-11.91|9.58|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600657|NCT02801942|2941016|Other||Mean Difference (Final Values)|-0.94|Standard Error of the Mean|1.056|||2-Sided|95.0|-3.24|1.36|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600658|NCT02801942|2941016|Other||Mean Difference (Final Values)|0.46|Standard Error of the Mean|1.304|||2-Sided|95.0|-2.27|3.19|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600659|NCT02801942|2941017|Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.869|||2-Sided|95.0|-2.06|1.72|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600660|NCT02801942|2941017|Other||Mean Difference (Final Values)|-0.65|Standard Error of the Mean|1.153|||2-Sided|95.0|-3.3|2.0|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600661|NCT02801942|2941017|Other||Mean Difference (Final Values)|3.42|Standard Error of the Mean|3.472|||2-Sided|95.0|-3.84|10.67|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600662|NCT02801942|2941017|Other||Mean Difference (Final Values)|-2.25|Standard Error of the Mean|4.299|||2-Sided|95.0|-11.23|6.73|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600663|NCT02801942|2941017|Other||Mean Difference (Final Values)|0.53|Standard Error of the Mean|2.185|||2-Sided|95.0|-4.05|5.11|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600664|NCT02801942|2941017|Other||Mean Difference (Final Values)|-1.47|Standard Error of the Mean|2.645|||2-Sided|95.0|-6.99|4.06|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600665|NCT02801942|2941017|Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|2.047|||2-Sided|95.0|-4.59|3.99|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600666|NCT02801942|2941017|Other||Mean Difference (Final Values)|-1.44|Standard Error of the Mean|2.117|||2-Sided|95.0|-5.98|3.11|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600667|NCT02801942|2941017|Other||Mean Difference (Final Values)|-2.8|Standard Error of the Mean|1.929|||2-Sided|95.0|-7.2|1.59|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600668|NCT02801942|2941017|Other||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|1.036|||2-Sided|95.0|-2.67|2.1|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600669|NCT02801942|2941017|Other||Mean Difference (Final Values)|-3.29|Standard Error of the Mean|1.682|||2-Sided|95.0|-6.82|0.24|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600670|NCT02801942|2941017|Other||Mean Difference (Final Values)|-4.9|Standard Error of the Mean|2.377|||2-Sided|95.0|-9.89|0.08|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600671|NCT02801942|2941017|Other||Mean Difference (Final Values)|0.72|Standard Error of the Mean|2.694|||2-Sided|95.0|-4.9|6.35|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600909|NCT02799472|2941105|Other||Mean Difference (Net)|27659.7||||0.321|2-Sided|95.0|-28567.8|83887.1|||Repeated measures analysis|||CD14br+CD16-, Week 4|
1600672|NCT02801942|2941017|Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|3.63|||2-Sided|95.0|-7.4|8.0|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600673|NCT02801942|2941018|Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.438|||2-Sided|95.0|-0.93|0.91|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600674|NCT02801942|2941018|Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.627|||2-Sided|95.0|-1.28|1.38|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600675|NCT02801942|2941018|Other||Mean Difference (Final Values)|3.95|Standard Error of the Mean|2.481|||2-Sided|95.0|-1.25|9.15|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600676|NCT02801942|2941018|Other||Mean Difference (Final Values)|2.15|Standard Error of the Mean|3.356|||2-Sided|95.0|-4.84|9.14|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600677|NCT02801942|2941018|Other||Mean Difference (Final Values)|0.42|Standard Error of the Mean|1.61|||2-Sided|95.0|-2.95|3.79|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600678|NCT02801942|2941018|Other||Mean Difference (Final Values)|0.53|Standard Error of the Mean|1.546|||2-Sided|95.0|-2.71|3.76|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600679|NCT02801942|2941018|Other||Mean Difference (Final Values)|0.38|Standard Error of the Mean|0.565|||2-Sided|95.0|-0.8|1.56|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600680|NCT02801942|2941018|Other||Mean Difference (Final Values)|0.43|Standard Error of the Mean|0.613|||2-Sided|95.0|-0.85|1.72|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600681|NCT02801942|2941018|Other||Mean Difference (Final Values)|0.59|Standard Error of the Mean|0.787|||2-Sided|95.0|-1.07|2.24|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600682|NCT02801942|2941018|Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.889|||2-Sided|95.0|-1.98|1.78|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600683|NCT02801942|2941018|Other||Mean Difference (Final Values)|-6.03|Standard Error of the Mean|2.708|||2-Sided|95.0|-11.69|-0.38|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600684|NCT02801942|2941018|Other||Mean Difference (Final Values)|-0.97|Standard Error of the Mean|3.631|||2-Sided|95.0|-8.56|6.63|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600685|NCT02801942|2941018|Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|1.339|||2-Sided|95.0|-2.75|2.85|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600686|NCT02801942|2941018|Other||Mean Difference (Final Values)|0.77|Standard Error of the Mean|1.709|||2-Sided|95.0|-2.78|4.33|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600687|NCT02801942|2941018|Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|1.507|||2-Sided|95.0|-3.21|3.24|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600688|NCT02801942|2941018|Other||Mean Difference (Final Values)|-1.26|Standard Error of the Mean|0.651|||2-Sided|95.0|-2.69|0.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600689|NCT02801942|2941018|Other||Mean Difference (Final Values)|-3.93|Standard Error of the Mean|4.828|||2-Sided|95.0|-14.02|6.17|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600690|NCT02801942|2941018|Other||Mean Difference (Final Values)|7.0|Standard Error of the Mean|4.671|||2-Sided|95.0|-2.8|16.81|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600691|NCT02801942|2941019|Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.325|||2-Sided|95.0|-1.1|0.26|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600692|NCT02801942|2941019|Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.314|||2-Sided|95.0|-0.67|0.65|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600693|NCT02801942|2941019|Other||Mean Difference (Final Values)|0.48|Standard Error of the Mean|4.976|||2-Sided|95.0|-9.91|10.87|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600694|NCT02801942|2941019|Other||Mean Difference (Final Values)|-2.09|Standard Error of the Mean|5.727|||2-Sided|95.0|-14.09|9.92|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600695|NCT02801942|2941019|Other||Mean Difference (Final Values)|2.06|Standard Error of the Mean|3.994|||2-Sided|95.0|-6.27|10.39|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600696|NCT02801942|2941019|Other||Mean Difference (Final Values)|2.25|Standard Error of the Mean|4.034|||2-Sided|95.0|-6.16|10.66|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600697|NCT02801942|2941019|Other||Mean Difference (Final Values)|-3.72|Standard Error of the Mean|4.223|||2-Sided|95.0|-12.57|5.13|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600698|NCT02801942|2941019|Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|4.22|||2-Sided|95.0|-9.02|8.64|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1669891|NCT01387815|3072821|Other|||||||0.434|||||||t-test, 2 sided||||
1600699|NCT02801942|2941019|Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.184|||2-Sided|95.0|-0.25|0.52|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600700|NCT02801942|2941019|Other||Mean Difference (Final Values)|0.39|Standard Error of the Mean|0.358|||2-Sided|95.0|-0.36|1.14|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600701|NCT02801942|2941020|Other||Mean Difference (Final Values)|-7.03|Standard Error of the Mean|7.114|||2-Sided|95.0|-22.22|8.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by core biopsy FNA method has been presented.||
1600702|NCT02801942|2941020|Other||Mean Difference (Final Values)|-5.39|Standard Error of the Mean|2.545|||2-Sided|95.0|-11.56|0.78|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600703|NCT02801942|2941022|Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.372|||2-Sided|95.0|-1.19|0.35|||||The mean difference in Stem Cell Memory-like CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600704|NCT02801942|2941022|Other||Mean Difference (Final Values)|-0.92|Standard Error of the Mean|0.708|||2-Sided|95.0|-2.42|0.58|||||The mean difference in Stem Cell Memory-like CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600705|NCT02801942|2941022|Other||Mean Difference (Final Values)|-2.18|Standard Error of the Mean|7.155|||2-Sided|95.0|-17.1|12.74|||||The mean difference in Naive CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600706|NCT02801942|2941022|Other||Mean Difference (Final Values)|3.51|Standard Error of the Mean|6.594|||2-Sided|95.0|-10.21|17.24|||||The mean difference in Naive CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600707|NCT02801942|2941022|Other||Mean Difference (Final Values)|-1.59|Standard Error of the Mean|3.071|||2-Sided|95.0|-8.0|4.81|||||The mean difference in Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600708|NCT02801942|2941022|Other||Mean Difference (Final Values)|-2.11|Standard Error of the Mean|3.132|||2-Sided|95.0|-8.65|4.43|||||The mean difference in Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600709|NCT02801942|2941022|Other||Mean Difference (Final Values)|-1.16|Standard Error of the Mean|1.851|||2-Sided|95.0|-5.03|2.71|||||The mean difference in Central Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600710|NCT02801942|2941022|Other||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|1.428|||2-Sided|95.0|-3.14|2.82|||||The mean difference in Central Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600711|NCT02801942|2941022|Other||Mean Difference (Final Values)|4.01|Standard Error of the Mean|3.418|||2-Sided|95.0|-3.13|11.16|||||The mean difference in CD45RA+ Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600712|NCT02801942|2941022|Other||Mean Difference (Final Values)|-1.62|Standard Error of the Mean|3.561|||2-Sided|95.0|-9.05|5.82|||||The mean difference in CD45RA+ Effector Memory CD8 cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600713|NCT02801942|2941024|Other||Mean Difference (Final Values)|-13.85|Standard Error of the Mean|5.781|||2-Sided|95.0|-26.04|-1.66|||||The mean difference in (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600714|NCT02801942|2941024|Other||Mean Difference (Final Values)|-7.89|Standard Error of the Mean|10.509|||2-Sided|95.0|-31.03|15.25|||||The mean difference in Plasmacytoid Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600715|NCT02801942|2941024|Other||Mean Difference (Final Values)|16.22|Standard Error of the Mean|6.189|||2-Sided|95.0|3.17|29.26|||||The mean difference in Myeloid Dendritic cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600716|NCT02801942|2941024|Other||Mean Difference (Final Values)|8.25|Standard Error of the Mean|7.673|||2-Sided|95.0|-8.58|25.08|||||The mean difference in Myeloid Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600717|NCT02801942|2941025|Other||Mean Difference (Final Values)|-2.79|Standard Error of the Mean|4.148|||2-Sided|95.0|-12.31|6.73|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600718|NCT02801942|2941025|Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|2.429|||2-Sided|95.0|-5.54|5.26|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600719|NCT02801942|2941025|Other||Mean Difference (Final Values)|4.25|Standard Error of the Mean|12.739|||2-Sided|95.0|-24.14|32.65|||||The mean difference in CD56lo CD16+ by (Healthy participants versus NOT1D participants) core biopsy method has been presented.||
1600720|NCT02801942|2941025|Other||Mean Difference (Final Values)|-20.03|Standard Error of the Mean|8.586|||2-Sided|95.0|-38.98|-1.08|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600721|NCT02801942|2941025|Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|7.566|||2-Sided|95.0|-16.85|16.78|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600722|NCT02801942|2941025|Other||Mean Difference (Final Values)|13.72|Standard Error of the Mean|7.475|||2-Sided|95.0|-2.72|30.15|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600723|NCT02801942|2941026|Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.417|||2-Sided|95.0|-0.99|0.82|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600724|NCT02801942|2941026|Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.766|||2-Sided|95.0|-1.72|1.6|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600864|NCT02801617|2941063|Non-Inferiority|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.039|||||||Chi-squared||||
1600725|NCT02801942|2941026|Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.221|||2-Sided|95.0|-0.59|0.4|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600726|NCT02801942|2941026|Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.114|||2-Sided|95.0|-0.03|0.47|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600727|NCT02801942|2941026|Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.068|||2-Sided|95.0|-0.17|0.12|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600728|NCT02801942|2941026|Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.068|||2-Sided|95.0|-0.16|0.13|||||The mean difference in CD56lo CD16- by (Healthy participants versus NOT1D participants) FNA method has been presented.||
1600729|NCT02801942|2941026|Other||Mean Difference (Final Values)|0.37|Standard Error of the Mean|0.312|||2-Sided|95.0|-0.33|1.07|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600730|NCT02801942|2941026|Other||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.402|||2-Sided|95.0|-1.27|0.49|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600731|NCT02801942|2941026|Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.147|||2-Sided|95.0|-0.37|0.27|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600732|NCT02801942|2941026|Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.189|||2-Sided|95.0|-0.26|0.54|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600733|NCT02801942|2941026|Other||Mean Difference (Final Values)|-1.88|Standard Error of the Mean|2.99|||2-Sided|95.0|-8.37|4.61|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600734|NCT02801942|2941026|Other||Mean Difference (Final Values)|4.97|Standard Error of the Mean|2.538|||2-Sided|95.0|-0.54|10.48|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600735|NCT02801942|2941027|Other||Mean Difference (Final Values)|-8.31|Standard Error of the Mean|6.019|||2-Sided|95.0|-21.49|4.87|||||The mean difference in Naive B Lymphocytes by (Healthy participants versus NOT1D participants) core biopsy method has been presented.||
1600736|NCT02801942|2941027|Other||Mean Difference (Final Values)|-8.3|Standard Error of the Mean|6.08|||2-Sided|95.0|-21.58|4.98|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600737|NCT02801942|2941027|Other||Mean Difference (Final Values)|-1.78|Standard Error of the Mean|1.755|||2-Sided|95.0|-5.54|1.98|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600738|NCT02801942|2941027|Other||Mean Difference (Final Values)|-1.37|Standard Error of the Mean|3.336|||2-Sided|95.0|-8.46|5.71|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600739|NCT02801942|2941027|Other||Mean Difference (Final Values)|5.64|Standard Error of the Mean|6.0|||2-Sided|95.0|-7.73|19.01|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600740|NCT02801942|2941027|Other||Mean Difference (Final Values)|11.54|Standard Error of the Mean|7.693|||2-Sided|95.0|-5.24|28.32|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600741|NCT02801942|2941027|Other||Mean Difference (Final Values)|4.46|Standard Error of the Mean|2.334|||2-Sided|95.0|-0.47|9.39|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) by core biopsy method has been presented.||
1600742|NCT02801942|2941027|Other||Mean Difference (Final Values)|2.29|Standard Error of the Mean|3.097|||2-Sided|95.0|-4.24|8.83|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) by FNA method has been presented.||
1600743|NCT02801942|2941028|Other||Mean Difference (Final Values)|2.14|Standard Error of the Mean|0.843|||2-Sided|95.0|0.36|3.92|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600744|NCT02801942|2941028|Other||Mean Difference (Final Values)|1.28|Standard Error of the Mean|2.042|||2-Sided|95.0|-14.56|17.13|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600745|NCT02801942|2941028|Other||Mean Difference (Final Values)|-2.06|Standard Error of the Mean|4.392|||2-Sided|95.0|-11.33|7.21|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600746|NCT02801942|2941028|Other||Mean Difference (Final Values)|3.01|Standard Error of the Mean|1.728|||2-Sided|95.0|-0.62|6.63|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600747|NCT02801942|2941029|Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.589|||2-Sided|95.0|-1.54|0.92|||||The mean difference in Ki67+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600748|NCT02801942|2941029|Other||Mean Difference (Final Values)|0.83|Standard Error of the Mean|0.594|||2-Sided|95.0|-0.41|2.07|||||The mean difference in Helios+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600749|NCT02801942|2941029|Other||Mean Difference (Final Values)|0.84|Standard Error of the Mean|0.351|||2-Sided|95.0|0.1|1.57|||||The mean difference in CD69+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600750|NCT02801942|2941029|Other||Mean Difference (Final Values)|0.57|Standard Error of the Mean|1.344|||2-Sided|95.0|-2.23|3.38|||||The mean difference in CD15s+ Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600751|NCT02801942|2941030|Other||Mean Difference (Final Values)|2.74|Standard Error of the Mean|0.872|||2-Sided|95.0|0.9|4.58|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1669892|NCT01387815|3072822|Other|||||||0.442|||||||t-test, 2 sided||||
1600752|NCT02801942|2941030|Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.957|||2-Sided|95.0|-1.86|2.14|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600753|NCT02801942|2941030|Other||Mean Difference (Final Values)|-2.55|Standard Error of the Mean|4.716|||2-Sided|95.0|-12.45|7.35|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600754|NCT02801942|2941030|Other||Mean Difference (Final Values)|1.78|Standard Error of the Mean|0.989|||2-Sided|95.0|-0.3|3.86|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600755|NCT02801942|2941031|Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.3|||2-Sided|95.0|-0.78|0.47|||||The mean difference in Ki67+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600756|NCT02801942|2941031|Other||Mean Difference (Final Values)|0.39|Standard Error of the Mean|0.345|||2-Sided|95.0|-0.33|1.11|||||The mean difference in Helios+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600757|NCT02801942|2941031|Other||Mean Difference (Final Values)|0.64|Standard Error of the Mean|0.306|||2-Sided|95.0|0.0|1.28|||||The mean difference in CD69+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600758|NCT02801942|2941031|Other||Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.601|||2-Sided|95.0|-0.94|1.57|||||The mean difference in CD15s+ Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600759|NCT02801942|2941032|Other||Mean Difference (Final Values)|8.31|Standard Error of the Mean|4.595|||2-Sided|95.0|-1.32|17.95|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600760|NCT02801942|2941032|Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|4.026|||2-Sided|95.0|-8.23|8.67|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600761|NCT02801942|2941032|Other||Mean Difference (Final Values)|3.3|Standard Error of the Mean|2.02|||2-Sided|95.0|-0.98|7.59|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600762|NCT02801942|2941032|Other||Mean Difference (Final Values)|2.11|Standard Error of the Mean|2.519|||2-Sided|95.0|-3.23|7.45|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600763|NCT02801942|2941032|Other||Mean Difference (Final Values)|-8.54|Standard Error of the Mean|4.595|||2-Sided|95.0|-18.17|1.1|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600764|NCT02801942|2941032|Other||Mean Difference (Final Values)|6.53|Standard Error of the Mean|4.905||||95.0|-3.78|16.85|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600765|NCT02801942|2941033|Other||Mean Difference (Final Values)|8.6|Standard Error of the Mean|4.733|||2-Sided|95.0|-1.27|18.47|||||The mean difference in Resting Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600766|NCT02801942|2941033|Other||Mean Difference (Final Values)|-4.86|Standard Error of the Mean|3.802|||2-Sided|95.0|-12.8|3.07|||||The mean difference in Memory Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600767|NCT02801942|2941033|Other||Mean Difference (Final Values)|-0.98|Standard Error of the Mean|0.985|||2-Sided|95.0|-3.03|1.08|||||The mean difference in Ki67+ T Reg cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600768|NCT02801942|2941033|Other||Mean Difference (Final Values)|4.21|Standard Error of the Mean|3.017|||2-Sided|95.0|-2.08|10.51|||||The mean difference in Helios+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600769|NCT02801942|2941033|Other||Mean Difference (Final Values)|0.92|Standard Error of the Mean|0.308|||2-Sided|95.0|0.28|1.57|||||The mean difference in CD69+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600770|NCT02801942|2941033|Other||Mean Difference (Final Values)|-1.29|Standard Error of the Mean|2.214|||2-Sided|95.0|-5.91|3.32|||||The mean difference in CD15s+ Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600771|NCT02801942|2941034|Other||Mean Difference (Final Values)|2.2|Standard Error of the Mean|1.051|||2-Sided|95.0|-0.04|4.44|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600772|NCT02801942|2941034|Other||Mean Difference (Final Values)|-2.77|Standard Error of the Mean|4.299|||2-Sided|95.0|-11.81|6.27|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600773|NCT02801942|2941035|Other||Mean Difference (Final Values)|-0.83|Standard Error of the Mean|0.58|||2-Sided|95.0|-2.04|0.38|||||The mean difference in Ki67+ CD8 cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600774|NCT02801942|2941035|Other||Mean Difference (Final Values)|0.95|Standard Error of the Mean|0.443|||2-Sided|95.0|0.02|1.87|||||The mean difference in CD69+ CD8 cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600775|NCT02801942|2941036|Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.929|||2-Sided|95.0|-2.18|1.7|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600776|NCT02801942|2941037|Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.601|||2-Sided|95.0|-0.86|1.65|||||The mean difference in Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600777|NCT02801942|2941038|Other||Mean Difference (Final Values)|-0.41|Standard Error of the Mean|0.811|||2-Sided|95.0|-2.21|1.4|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600778|NCT02801942|2941038|Other||Mean Difference (Final Values)|0.58|Standard Error of the Mean|3.405|||2-Sided|95.0|-6.52|7.68|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600779|NCT02801942|2941038|Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|2.193|||2-Sided|95.0|-5.02|4.09|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1669893|NCT01387815|3072823|Other|||||||0.793|||||||t-test, 2 sided||||
1600780|NCT02801942|2941038|Other||Mean Difference (Final Values)|-0.87|Standard Error of the Mean|1.725|||2-Sided|95.0|-4.51|2.77|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600781|NCT02801942|2941038|Other||Mean Difference (Final Values)|-1.55|Standard Error of the Mean|1.209|||2-Sided|95.0|-4.34|1.24|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600782|NCT02801942|2941038|Other||Mean Difference (Final Values)|-4.1|Standard Error of the Mean|1.842|||2-Sided|95.0|-7.93|-0.26|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600783|NCT02801942|2941038|Other||Mean Difference (Final Values)|0.51|Standard Error of the Mean|2.918|||2-Sided|95.0|-5.6|6.63|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600784|NCT02801942|2941039|Other||Mean Difference (Final Values)|-1.16|Standard Error of the Mean|1.413|||2-Sided|95.0|-4.11|1.78|||||The mean difference in TH22 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600785|NCT02801942|2941039|Other||Mean Difference (Final Values)|3.38|Standard Error of the Mean|1.907|||2-Sided|95.0|-0.59|7.36|||||The mean difference in TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600786|NCT02801942|2941039|Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|1.289|||2-Sided|95.0|-2.99|2.39|||||The mean difference in TH17 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600787|NCT02801942|2941039|Other||Mean Difference (Final Values)|1.81|Standard Error of the Mean|0.963|||2-Sided|95.0|-0.2|3.81|||||The mean difference in TH1 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600788|NCT02801942|2941039|Other||Mean Difference (Final Values)|-2.88|Standard Error of the Mean|1.536||||95.0|-6.08|0.33|||||The mean difference in TH1 TH17 TH2 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600789|NCT02801942|2941039|Other||Mean Difference (Final Values)|-0.83|Standard Error of the Mean|0.953|||2-Sided|95.0|-2.82|1.16|||||The mean difference in TH1 cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600790|NCT02801942|2941039|Other||Mean Difference (Final Values)|-4.83|Standard Error of the Mean|2.82|||2-Sided|95.0|-10.71|1.05|||||The mean difference in TFH cells-like Reg T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600791|NCT02801942|2941040|Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.448|||2-Sided|95.0|-0.92|0.96|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600792|NCT02801942|2941040|Other||Mean Difference (Final Values)|3.05|Standard Error of the Mean|2.641|||2-Sided|95.0|-2.45|8.55|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600793|NCT02801942|2941040|Other||Mean Difference (Final Values)|0.48|Standard Error of the Mean|1.246|||2-Sided|95.0|-2.12|3.07|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600794|NCT02801942|2941040|Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.544|||2-Sided|95.0|-0.73|1.54|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600795|NCT02801942|2941040|Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.738|||2-Sided|95.0|-1.29|1.78|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600796|NCT02801942|2941040|Other||Mean Difference (Final Values)|-3.5|Standard Error of the Mean|2.824|||2-Sided|95.0|-9.39|2.39|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600797|NCT02801942|2941040|Other||Mean Difference (Final Values)|0.41|Standard Error of the Mean|1.391|||2-Sided|95.0|-2.49|3.31|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600798|NCT02801942|2941040|Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.855|||2-Sided|95.0|-2.43|1.18|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600799|NCT02801942|2941040|Other||Mean Difference (Final Values)|1.54|Standard Error of the Mean|3.607|||2-Sided|95.0|-5.99|9.07|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600800|NCT02801942|2941041|Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.504|||2-Sided|95.0|-1.05|1.05|||||The mean difference in TH22 cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600801|NCT02801942|2941041|Other||Mean Difference (Final Values)|1.57|Standard Error of the Mean|1.474|||2-Sided|95.0|-1.51|4.64|||||The mean difference in TH2 cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600802|NCT02801942|2941041|Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|1.026|||2-Sided|95.0|-2.73|1.55|||||The mean difference in TH1 TH2 cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600803|NCT02801942|2941041|Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|1.112|||2-Sided|95.0|-2.31|2.32|||||The mean difference in TH1 TH17 TH2 T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600804|NCT02801942|2941041|Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|2.382|||2-Sided|95.0|-4.94|5.0|||||The mean difference in TH1 TH17 cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600805|NCT02801942|2941041|Other||Mean Difference (Final Values)|2.09|Standard Error of the Mean|4.294|||2-Sided|95.0|-6.87|11.05|||||The mean difference in TH1 cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600806|NCT02801942|2941041|Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|1.428|||2-Sided|95.0|-3.08|2.88|||||The mean difference in TH17 cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600807|NCT02801942|2941041|Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.05|||2-Sided|95.0|-0.15|0.07|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600808|NCT02801942|2941041|Other||Mean Difference (Final Values)|-5.09|Standard Error of the Mean|2.556|||2-Sided|95.0|-10.42|0.25|||||The mean difference in TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600809|NCT02801942|2941042|Other||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.268|||2-Sided|95.0|-0.77|0.34|||||The mean difference in Stem cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600810|NCT02801942|2941042|Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|4.629|||2-Sided|95.0|-10.47|8.86|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600811|NCT02801942|2941042|Other||Mean Difference (Final Values)|2.15|Standard Error of the Mean|3.621|||2-Sided|95.0|-5.38|9.69|||||The mean difference in Effector Memory Conv T cells(Healthy participants versus NOT1D participants) in iLN has been presented.||
1600812|NCT02801942|2941042|Other||Mean Difference (Final Values)|-1.95|Standard Error of the Mean|3.943|||2-Sided|95.0|-10.2|6.29|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600813|NCT02801942|2941042|Other||Mean Difference (Final Values)|0.26|Standard Error of the Mean|0.236||||95.0|-0.23|0.75|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600814|NCT02801942|2941043|Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.145|||2-Sided|95.0|-0.4|0.21|||||The mean difference in Stem Cell Memory-like Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600815|NCT02801942|2941043|Other||Mean Difference (Final Values)|0.92|Standard Error of the Mean|3.835|||2-Sided|95.0|-7.08|8.92|||||The mean difference in Naive Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600816|NCT02801942|2941043|Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|2.089|||2-Sided|95.0|-4.59|4.13|||||The mean difference in Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600817|NCT02801942|2941043|Other||Mean Difference (Final Values)|-1.54|Standard Error of the Mean|3.152|||2-Sided|95.0|-8.12|5.03|||||The mean difference in Central Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600818|NCT02801942|2941043|Other||Mean Difference (Final Values)|1.03|Standard Error of the Mean|1.269|||2-Sided|95.0|-1.61|3.68|||||The mean difference in CD45RA+ Effector Memory Conv T cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600819|NCT02801942|2941044|Other||Mean Difference (Final Values)|-6.21|Standard Error of the Mean|4.362|||2-Sided|95.0|-15.37|2.96|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600820|NCT02801942|2941045|Other||Mean Difference (Final Values)|-0.34|Standard Error of the Mean|0.236|||2-Sided|95.0|-0.84|0.16|||||The mean difference in PD-1+ ICOS+ TFH cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600821|NCT02801942|2941048|Other||Mean Difference (Final Values)|-0.67|Standard Error of the Mean|0.492|||2-Sided|95.0|-1.71|0.36|||||The mean difference in Stem Cell Memory-like CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600822|NCT02801942|2941048|Other||Mean Difference (Final Values)|0.67|Standard Error of the Mean|6.342|||2-Sided|95.0|-12.54|13.87|||||The mean difference in Naive CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600823|NCT02801942|2941048|Other||Mean Difference (Final Values)|-1.85|Standard Error of the Mean|2.79|||2-Sided|95.0|-7.67|3.96|||||The mean difference in Effector Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600824|NCT02801942|2941048|Other||Mean Difference (Final Values)|-0.66|Standard Error of the Mean|1.466|||2-Sided|95.0|-3.73|2.41|||||The mean difference in Central Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600825|NCT02801942|2941048|Other||Mean Difference (Final Values)|1.2|Standard Error of the Mean|3.133|||2-Sided|95.0|-5.33|7.73|||||The mean difference in CD45RA+ Effector Memory CD8 (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600826|NCT02801942|2941049|Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.305|||2-Sided|95.0|-0.67|0.6|||||The mean difference in Stem Cell Memory-like CD8 (Healthy participants versus NOT1D participants) in blood has been presented.||
1600827|NCT02801942|2941049|Other||Mean Difference (Final Values)|-6.06|Standard Error of the Mean|5.729|||2-Sided|95.0|-18.01|5.89|||||The mean difference in Naive CD8 (Healthy participants versus NOT1D participants) in blood has been presented.||
1600828|NCT02801942|2941049|Other||Mean Difference (Final Values)|4.38|Standard Error of the Mean|3.297|||2-Sided|95.0|-2.5|11.26|||||The mean difference in Effector Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.||
1600829|NCT02801942|2941049|Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|2.28|||2-Sided|95.0|-4.6|4.91|||||The mean difference in Central Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.||
1600830|NCT02801942|2941049|Other||Mean Difference (Final Values)|1.79|Standard Error of the Mean|6.329|||2-Sided|95.0|-11.41|14.99|||||The mean difference in CD45RA+ Effector Memory CD8 (Healthy participants versus NOT1D participants) in blood has been presented.||
1600831|NCT02801942|2941052|Other||Mean Difference (Final Values)|-10.87|Standard Error of the Mean|6.961|||2-Sided|95.0|-25.52|3.78|||||The mean difference in plasmacytoid dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600832|NCT02801942|2941052|Other||Mean Difference (Final Values)|12.23|Standard Error of the Mean|5.658|||2-Sided|95.0|0.38|24.09|||||The mean difference in myeloid dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600833|NCT02801942|2941053|Other||Mean Difference (Final Values)|-1.85|Standard Error of the Mean|4.658|||2-Sided|95.0|-11.57|7.86|||||The mean difference in plasmacytoid dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600834|NCT02801942|2941053|Other||Mean Difference (Final Values)|1.33|Standard Error of the Mean|4.558|||2-Sided|95.0|-8.17|10.84|||||The mean difference in myeloid dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600995|NCT02799472|2941110|Other||Ratio|0.709||||0.054|2-Sided|95.0|0.499|1.006|||Repeated measures analysis|||CD16+CD56+, 12-Week FU|
1600835|NCT02801942|2941054|Other||Mean Difference (Final Values)|-1.46|Standard Error of the Mean|2.379|||2-Sided|95.0|-6.66|3.73|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600836|NCT02801942|2941054|Other||Mean Difference (Final Values)|-7.89|Standard Error of the Mean|7.918|||2-Sided|95.0|-24.77|9.0|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600837|NCT02801942|2941054|Other||Mean Difference (Final Values)|6.84|Standard Error of the Mean|5.564|||2-Sided|95.0|-4.92|18.6|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600838|NCT02801942|2941055|Other||Mean Difference (Final Values)|0.42|Standard Error of the Mean|0.738|||2-Sided|95.0|-1.12|1.95|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in blood has been presented.||
1600839|NCT02801942|2941055|Other||Mean Difference (Final Values)|-2.69|Standard Error of the Mean|2.324|||2-Sided|95.0|-7.54|2.16|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in blood has been presented.||
1600840|NCT02801942|2941055|Other||Mean Difference (Final Values)|1.03|Standard Error of the Mean|1.326|||2-Sided|95.0|-1.73|3.8|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600841|NCT02801942|2941056|Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.487|||2-Sided|95.0|-1.1|0.96|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600842|NCT02801942|2941056|Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.128|||2-Sided|95.0|-0.21|0.34|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600843|NCT02801942|2941056|Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.059|||2-Sided|95.0|-0.15|0.1|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600844|NCT02801942|2941056|Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.253|||2-Sided|95.0|-0.54|0.52|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600845|NCT02801942|2941056|Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.25|0.34|||||The mean difference in CD56bright sNK cells (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600846|NCT02801942|2941056|Other||Mean Difference (Final Values)|1.54|Standard Error of the Mean|2.231|||2-Sided|95.0|-3.14|6.23|||||The mean difference in B-cells in (Healthy participants versus NOT1D participants) iLN has been presented.||
1600847|NCT02801942|2941057|Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|1.482|||2-Sided|95.0|-3.23|2.96|||||The mean difference in NK cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600848|NCT02801942|2941057|Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.118|||2-Sided|95.0|-0.19|0.31|||||The mean difference in Dendritic cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600849|NCT02801942|2941057|Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.054|||2-Sided|95.0|-0.1|0.13|||||The mean difference in CD56lo CD16- (Healthy participants versus NOT1D participants) in blood has been presented.||
1600850|NCT02801942|2941057|Other||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|1.5|||2-Sided|95.0|-3.41|2.84|||||The mean difference in CD56lo CD16+ (Healthy participants versus NOT1D participants) in blood has been presented.||
1600851|NCT02801942|2941057|Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.063|||2-Sided|95.0|-0.07|0.19|||||The mean difference in CD56bright NK cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600852|NCT02801942|2941057|Other||Mean Difference (Final Values)|0.92|Standard Error of the Mean|0.873|||2-Sided|95.0|-0.9|2.75|||||The mean difference in B-cells (Healthy participants versus NOT1D participants) in blood has been presented.||
1600853|NCT02801942|2941058|Other||Mean Difference (Final Values)|-8.31|Standard Error of the Mean|5.221|||2-Sided|95.0|-19.32|2.71|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600854|NCT02801942|2941058|Other||Mean Difference (Final Values)|-1.58|Standard Error of the Mean|2.347|||2-Sided|95.0|-6.53|3.38|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600855|NCT02801942|2941058|Other||Mean Difference (Final Values)|8.59|Standard Error of the Mean|5.833|||2-Sided|95.0|-3.72|20.91|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600856|NCT02801942|2941058|Other||Mean Difference (Final Values)|3.38|Standard Error of the Mean|2.658|||2-Sided|95.0|-2.22|8.98|||||The mean difference in Circulating B Lymphocytes (Healthy participants versus NOT1D participants) in iLN has been presented.||
1600857|NCT02801942|2941059|Other||Mean Difference (Final Values)|-2.51|Standard Error of the Mean|4.482||||95.0|-11.86|6.84|||||The mean difference in Naive B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.||
1600858|NCT02801942|2941059|Other||Mean Difference (Final Values)|-3.01|Standard Error of the Mean|1.854|||2-Sided|95.0|-6.87|0.86|||||The mean difference in Double Negative B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.||
1600859|NCT02801942|2941059|Other||Mean Difference (Final Values)|3.54|Standard Error of the Mean|2.398|||2-Sided|95.0|-1.46|8.54|||||The mean difference in Classical B Lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.||
1600860|NCT02801942|2941059|Other||Mean Difference (Final Values)|2.31|Standard Error of the Mean|3.307|||2-Sided|95.0|-4.59|9.21|||||The mean difference in circulating B lymphocytes (Healthy participants versus NOT1D participants) in blood has been presented.||
1600861|NCT02801877|2941060|Superiority|||||||0.53|||||||Mixed Models Analysis|F(3, 835)=0.73||Interactive effect of time and group, adjusting for baseline GAD-7, randomization strata, main and interactive effects of time, coach, coach*time, hub, and hub*time.|
1600862|NCT02801877|2941061|Superiority|||||||0.9|||||||Mixed Models Analysis|F(3, 835)=0.19||Interactive effect of time and group, adjusting for baseline PHQ-9, randomization strata, main and interactive effects of time, coach, coach*time, hub, and hub*time.|
1669894|NCT01387815|3072824|Other|||||||0.521|||||||t-test, 2 sided||||
1600865|NCT02801617|2941064|Non-Inferiority|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0|||||||Chi-squared, Corrected||||
1600866|NCT02801617|2941065|Non-Inferiority|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.434|||||||Chi-squared, Corrected||||
1600867|NCT02801617|2941066|Non-Inferiority|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.125|||||||Chi-squared, Corrected||||
1600868|NCT02801617|2941067|Non-Inferiority|it will be considered not inferior if they keep the percentage of ocular burning with differences of no more than 20%||||||0.388|||||||Chi-squared, Corrected||||
1600869|NCT02801617|2941068|Non-Inferiority|intention-to-treat analysis (ITT)||||||0.329|||||||Chi-squared||||
1600870|NCT02801617|2941069|Non-Inferiority|it will be considered not inferior if they keep the TIOP with differences of no more than 2 mmHg||||||0.89|||||||t-test, 2 sided||||
1600871|NCT02801617|2941069|Non-Inferiority|it will be considered not inferior if they keep the IOP goal with differences of no more than 2 mmHg analysis by protocol||||||0.861|||||||t-test, 2 sided||||
1600872|NCT02800356|2941083|Other|||||||0.267|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis|||
1600873|NCT02800356|2941086|Other|||||||0.001|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis|||
1600874|NCT02800356|2941087|Other|||||||0.232|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis|||
1600875|NCT02800356|2941088|Other|||||||0.404|||||||ANOVA|Analysis of Variance (ANOVA) for paired samples with Bonferroni post-hoc analysis|||
1600876|NCT02800213|2941089|Superiority|||||||0.28|||||||t-test, 2 sided||||
1600877|NCT02799784|2941090|Non-Inferiority|If the lower bound of the two-sided 95% confidence interval around the (UMEC/VI 62.5/25 mcg versus TIO/OLO 5/5 mcg) treatment difference is above -50 milliliter then UMEC/VI 62.5/25 mcg was to be considered non-inferior to TIO/OLO 5/5 mcg.|Mean Difference (Final Values)|0.053|||<|0.001|2-Sided|95.0|0.026|0.08|||Mixed Models Analysis||||
1600878|NCT02799472|2941091|Other||Mean Difference (Net)|0.0005||||0.85|2-Sided|95.0|-0.0048|0.0058|||Repeated measures analysis|||12-Week FU|
1600879|NCT02799472|2941091|Other||Mean Difference (Net)|-0.0004||||0.771|2-Sided|95.0|-0.0028|0.0021|||Repeated measures analysis|||Week 12|
1600880|NCT02799472|2941091|Other||Mean Difference (Net)|-0.0002||||0.915|2-Sided|95.0|-0.0033|0.0029|||Repeated measures analysis|||Week 4|
1600881|NCT02799472|2941092|Other||Mean Difference (Net)|0.001||||0.588|2-Sided|95.0|-0.0028|0.0049|||Repeated measures analysis|||12-Week FU|
1600882|NCT02799472|2941092|Other||Mean Difference (Net)|0.0036||||0.375|2-Sided|95.0|-0.0046|0.0118|||Repeated measures analysis|||Week 12|
1600883|NCT02799472|2941092|Other||Mean Difference (Net)|0.0128||||0.291|2-Sided|95.0|-0.0123|0.038|||Repeated measures analysis|||Week 4|
1600884|NCT02799472|2941093|Other||Mean Difference (Net)|-1536.0||||0.352|2-Sided|95.0|-4884.2|1812.1|||Repeated measures analysis|||12-Week FU|
1600885|NCT02799472|2941093|Other||Mean Difference (Net)|-504.8||||0.749|2-Sided|95.0|-3730.4|2720.9|||Repeated measures analysis|||Week 12|
1600886|NCT02799472|2941093|Other||Mean Difference (Net)|211.4||||0.874|2-Sided|95.0|-2589.2|3012.0|||Repeated measures analysis|||Week 4|
1600887|NCT02799472|2941094|Other||Mean Difference (Net)|-0.9||||0.086|2-Sided|95.0|-2.0|0.1|||Repeated measures analysis|||12-Week FU|
1600888|NCT02799472|2941094|Other||Mean Difference (Net)|-0.4||||0.475|2-Sided|95.0|-1.5|0.7|||Repeated measures analysis|||Week 12|
1600889|NCT02799472|2941094|Other||Mean Difference (Net)|0.0||||0.945|2-Sided|95.0|-1.1|1.2|||Repeated measures analysis|||Week 4|
1600890|NCT02799472|2941095|Other||Mean Difference (Net)|-1.3||||0.396|2-Sided|95.0|-4.4|1.8|||Repeated measures analysis|||12-Week FU|
1600891|NCT02799472|2941095|Other||Mean Difference (Net)|-0.8||||0.521|2-Sided|95.0|-3.2|1.6|||Repeated measures analysis|||Week 12|
1600892|NCT02799472|2941095|Other||Mean Difference (Net)|0.0||||0.94|2-Sided|95.0|-0.2|0.3|||Repeated measures analysis|||Week 4|
1600893|NCT02799472|2941096|Other||Median Difference (Net)|-2.28||||0.051|2-Sided|95.0|-5.02|0.45|||Repeated Measures Bayesian Model|||12-Week FU, For Posterior Probability Difference >0|
1600894|NCT02799472|2941096|Other||Median Difference (Net)|-2.18||||0.052|2-Sided|95.0|-4.77|0.51|||Repeated Measures Bayesian Model|||Week 12, For Posterior Probability Difference >0|
1600895|NCT02799472|2941096|Other||Median Difference (Net)|-0.13||||0.453|2-Sided|95.0|-2.32|2.23|||Repeated Measures Bayesian Model|||Week 4, For Posterior Probability Difference >0|
1600896|NCT02799472|2941096|Other||Median Difference (Net)|-2.28||||0.949|2-Sided|95.0|-5.02|0.45|||Repeated Measures Bayesian Model|||12-Week FU, For Posterior Probability Difference <0|
1600897|NCT02799472|2941096|Other||Median Difference (Net)|-2.18||||0.948|2-Sided|95.0|-4.77|0.51|||Repeated Measures Bayesian Model|||Week 12, For Posterior Probability Difference <0|
1600898|NCT02799472|2941096|Other||Median Difference (Net)|-0.13||||0.547|2-Sided|95.0|-2.32|2.23|||Repeated Measures Bayesian Model|||Week 4, For Posterior Probability Difference <0|
1600899|NCT02799472|2941104|Other||Mean Difference (Net)|41.6||||0.932|2-Sided|95.0|-962.2|1045.5|||Repeated measures analysis|||12-Week FU|
1600900|NCT02799472|2941104|Other||Mean Difference (Net)|-252.6||||0.629|2-Sided|95.0|-1326.0|820.8|||Repeated measures analysis|||Week 12|
1600901|NCT02799472|2941104|Other||Mean Difference (Net)|540.4||||0.216|2-Sided|95.0|-335.7|1416.5|||Repeated measures analysis|||Week 4|
1600902|NCT02799472|2941104|Other||Mean Difference (Net)|178.2||||0.564|2-Sided|95.0|-448.3|804.6|||Repeated measures analysis|||Week 1|
1600903|NCT02799472|2941105|Other||Mean Difference (Net)|-20744.2||||0.026|2-Sided|95.0|-38771.8|-2716.5|||Repeated measures analysis|||CD14lo+CD16br+, 12-Week FU|
1600904|NCT02799472|2941105|Other||Mean Difference (Net)|-10179.1||||0.084|2-Sided|95.0|-21827.4|1469.2|||Repeated measures analysis|||CD14lo+CD16br+, Week 12|
1600905|NCT02799472|2941105|Other||Mean Difference (Net)|-2231.6||||0.603|2-Sided|95.0|-10976.8|6513.6|||Repeated measures analysis|||CD14lo+CD16br+, Week 4|
1600906|NCT02799472|2941105|Other||Mean Difference (Net)|-6913.6||||0.366|2-Sided|95.0|-22588.4|8761.1|||Repeated measures analysis|||CD14lo+CD16br+, Week 1|
1600910|NCT02799472|2941105|Other||Mean Difference (Net)|-22417.0||||0.628|2-Sided|95.0|-116677.8|71843.8|||Repeated measures analysis|||CD14br+CD16-, Week 1|
1600911|NCT02799472|2941105|Other||Mean Difference (Net)|-3757.2||||0.741|2-Sided|95.0|-27146.0|19631.6|||Repeated measures analysis|||CD14br+CD16+, 12-Week FU|
1600912|NCT02799472|2941105|Other||Mean Difference (Net)|-22683.6||||0.04|2-Sided|95.0|-44298.5|-1068.8|||Repeated measures analysis|||CD14br+CD16+, Week 12|
1600913|NCT02799472|2941105|Other||Mean Difference (Net)|8359.6||||0.227|2-Sided|95.0|-5533.3|22252.5|||Repeated measures analysis|||CD14br+CD16+, Week 4|
1600914|NCT02799472|2941105|Other||Mean Difference (Net)|6866.9||||0.212|2-Sided|95.0|-4230.7|17964.6|||Repeated measures analysis|||CD14br+CD16+, Week 1|
1600915|NCT02799472|2941105|Other||Mean Difference (Net)|-311.6||||0.956|2-Sided|95.0|-11960.5|11337.4|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, 12-Week FU|
1600916|NCT02799472|2941105|Other||Mean Difference (Net)|-277.4||||0.961|2-Sided|95.0|-12001.0|11446.2|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 12|
1600917|NCT02799472|2941105|Other||Mean Difference (Net)|-487.5||||0.895|2-Sided|95.0|-8003.7|7028.6|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 4|
1600918|NCT02799472|2941105|Other||Mean Difference (Net)|2756.3||||0.328|2-Sided|95.0|-2953.7|8466.3|||Repeated measures analysis|||CD14-HLA-DR+CD11cbr+CD123-, Week 1|
1600919|NCT02799472|2941106|Other||Mean Difference (Net)|-1210.2||||0.534|2-Sided|95.0|-5213.1|2792.7|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, 12-Week FU|
1600920|NCT02799472|2941106|Other||Mean Difference (Net)|1435.3||||0.6|2-Sided|95.0|-4101.4|6972.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 12|
1600921|NCT02799472|2941106|Other||Mean Difference (Net)|-447.3||||0.894|2-Sided|95.0|-7285.5|6390.8|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 4|
1600922|NCT02799472|2941106|Other||Mean Difference (Net)|3276.8||||0.196|2-Sided|95.0|-1786.0|8339.6|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3-, Week 1|
1600923|NCT02799472|2941106|Other||Mean Difference (Net)|-1688.9||||0.41|2-Sided|95.0|-5864.1|2486.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, 12-Week FU|
1600924|NCT02799472|2941106|Other||Mean Difference (Net)|-1347.4||||0.633|2-Sided|95.0|-7073.1|4378.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 12|
1600925|NCT02799472|2941106|Other||Mean Difference (Net)|-268.0||||0.891|2-Sided|95.0|-4269.2|3733.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 4|
1600926|NCT02799472|2941106|Other||Mean Difference (Net)|1150.0||||0.333|2-Sided|95.0|-1250.0|3550.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6-CXCR3+, Week 1|
1600927|NCT02799472|2941106|Other||Mean Difference (Net)|-197.6||||0.755|2-Sided|95.0|-1499.3|1104.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, 12-Week FU|
1600928|NCT02799472|2941106|Other||Mean Difference (Net)|-268.5||||0.658|2-Sided|95.0|-1507.5|970.5|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 12|
1600929|NCT02799472|2941106|Other||Mean Difference (Net)|-183.5||||0.742|2-Sided|95.0|-1317.4|950.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 4|
1600930|NCT02799472|2941106|Other||Mean Difference (Net)|162.7||||0.719|2-Sided|95.0|-754.5|1079.9|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3-, Week 1|
1600931|NCT02799472|2941106|Other||Mean Difference (Net)|225.1||||0.804|2-Sided|95.0|-1633.1|2083.2|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, 12-Week FU|
1600932|NCT02799472|2941106|Other||Mean Difference (Net)|-253.5||||0.784|2-Sided|95.0|-2136.7|1629.7|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 12|
1600933|NCT02799472|2941106|Other||Mean Difference (Net)|-199.8||||0.822|2-Sided|95.0|-2001.7|1602.0|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 4|
1600934|NCT02799472|2941106|Other||Mean Difference (Net)|-515.6||||0.489|2-Sided|95.0|-2021.4|990.1|||Repeated measures analysis|||CD45+CD3+CD8-CD4+CCR6+CXCR3+, Week 1|
1600935|NCT02799472|2941106|Other||Mean Difference (Net)|-3631.0||||0.23|2-Sided|95.0|-9738.9|2476.8|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, 12-Week FU|
1600936|NCT02799472|2941106|Other||Mean Difference (Net)|-1106.0||||0.815|2-Sided|95.0|-10706.0|8494.1|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 12|
1600937|NCT02799472|2941106|Other||Mean Difference (Net)|-547.6||||0.875|2-Sided|95.0|-7612.6|6517.3|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 4|
1600938|NCT02799472|2941106|Other||Mean Difference (Net)|3682.3||||0.234|2-Sided|95.0|-2511.9|9876.5|||Repeated measures analysis|||CD45+CD3+CD8-CD4+, Week 1|
1600939|NCT02799472|2941106|Other||Mean Difference (Net)|-47.2||||0.249|2-Sided|95.0|-135.5|41.0|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, 12-Week FU|
1600940|NCT02799472|2941106|Other||Mean Difference (Net)|59.4||||0.789|2-Sided|95.0|-395.2|513.9|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 12|
1600941|NCT02799472|2941106|Other||Mean Difference (Net)|-17.4||||0.634|2-Sided|95.0|-94.3|59.6|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 4|
1600942|NCT02799472|2941106|Other||Mean Difference (Net)|0.4||||0.989|2-Sided|95.0|-60.5|61.3|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3-38+DR+, Week 1|
1600943|NCT02799472|2941106|Other||Mean Difference (Net)|-137.9||||0.08|2-Sided|95.0|-294.0|18.2|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, 12-Week FU|
1600944|NCT02799472|2941106|Other||Mean Difference (Net)|-141.5||||0.675|2-Sided|95.0|-829.2|546.3|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 12|
1600945|NCT02799472|2941106|Other||Mean Difference (Net)|51.6||||0.47|2-Sided|95.0|-93.9|197.0|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 4|
1600946|NCT02799472|2941106|Other||Mean Difference (Net)|-56.0||||0.559|2-Sided|95.0|-249.8|137.7|||Repeated measures analysis|||CD45+3+8-4+CCR6-CXCR3+38+DR+, Week 1|
1600947|NCT02799472|2941106|Other||Mean Difference (Net)|-5.7||||0.687|2-Sided|95.0|-34.4|23.0|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, 12-Week FU|
1600948|NCT02799472|2941106|Other||Mean Difference (Net)|-6.5||||0.718|2-Sided|95.0|-43.1|30.1|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 12|
1600949|NCT02799472|2941106|Other||Mean Difference (Net)|-2.1||||0.91|2-Sided|95.0|-39.4|35.2|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 4|
1600950|NCT02799472|2941106|Other||Mean Difference (Net)|6.5||||0.403|2-Sided|95.0|-9.3|22.4|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3-38+DR+, Week 1|
1600951|NCT02799472|2941106|Other||Mean Difference (Net)|-30.1||||0.119|2-Sided|95.0|-68.6|8.3|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, 12-Week FU|
1600952|NCT02799472|2941106|Other||Mean Difference (Net)|-49.2||||0.249|2-Sided|95.0|-135.2|36.8|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 12|
1600953|NCT02799472|2941106|Other||Mean Difference (Net)|8.4||||0.697|2-Sided|95.0|-35.3|52.0|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 4|
1600954|NCT02799472|2941106|Other||Mean Difference (Net)|14.6||||0.35|2-Sided|95.0|-16.9|46.1|||Repeated measures analysis|||CD45+3+8-4+CCR6+CXCR3+38+DR+, Week 1|
1600955|NCT02799472|2941107|Other||Mean Difference (Net)|4.1||||0.55|2-Sided|95.0|-9.8|18.0|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, 12-Week FU|
1600956|NCT02799472|2941107|Other||Mean Difference (Net)|-7.1||||0.433|2-Sided|95.0|-25.4|11.2|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 12|
1600957|NCT02799472|2941107|Other||Mean Difference (Net)|-2.2||||0.786|2-Sided|95.0|-18.8|14.4|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 4|
1600958|NCT02799472|2941107|Other||Mean Difference (Net)|2.0||||0.788|2-Sided|95.0|-13.0|17.0|||Repeated measures analysis|||CD3+CD4+foxP3+CD25+CD127-, Week 1|
1600959|NCT02799472|2941107|Other||Mean Difference (Net)|10.5||||0.363|2-Sided|95.0|-13.0|34.1|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, 12-Week FU|
1600960|NCT02799472|2941107|Other||Mean Difference (Net)|6.3||||0.572|2-Sided|95.0|-16.4|29.0|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 12|
1600961|NCT02799472|2941107|Other||Mean Difference (Net)|-1.8||||0.852|2-Sided|95.0|-21.6|18.0|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 4|
1600962|NCT02799472|2941107|Other||Mean Difference (Net)|6.5||||0.501|2-Sided|95.0|-13.1|26.1|||Repeated measures analysis|||CD3+CD4+CD25+CD127-, Week 1|
1600963|NCT02799472|2941108|Other||Ratio|1.049||||0.704|2-Sided|95.0|0.811|1.356|||Repeated measures analysis|||CD3+, 12-Week FU|
1600964|NCT02799472|2941108|Other||Ratio|1.036||||0.748|2-Sided|95.0|0.831|1.291|||Repeated measures analysis|||CD3+, Week 12|
1600965|NCT02799472|2941108|Other||Ratio|0.907||||0.519|2-Sided|95.0|0.668|1.232|||Repeated measures analysis|||CD3+, Week 4|
1600966|NCT02799472|2941108|Other||Ratio|1.101||||0.405|2-Sided|95.0|0.872|1.391|||Repeated measures analysis|||CD3+, Week 1|
1600967|NCT02799472|2941108|Other||Ratio|1.032||||0.806|2-Sided|95.0|0.797|1.335|||Repeated measures analysis|||CD3+ CD8+, 12-Week FU|
1600968|NCT02799472|2941108|Other||Ratio|1.076||||0.537|2-Sided|95.0|0.846|1.37|||Repeated measures analysis|||CD3+ CD8+, Week 12|
1600969|NCT02799472|2941108|Other||Ratio|0.957||||0.751|2-Sided|95.0|0.724|1.265|||Repeated measures analysis|||CD3+ CD8+, Week 4|
1600970|NCT02799472|2941108|Other||Ratio|1.111||||0.363|2-Sided|95.0|0.88|1.402|||Repeated measures analysis|||CD3+ CD8+, Week 1|
1600971|NCT02799472|2941108|Other||Ratio|1.082||||0.558|2-Sided|95.0|0.821|1.427|||Repeated measures analysis|||CD3+ CD4+, 12-Week FU|
1600972|NCT02799472|2941108|Other||Ratio|1.024||||0.844|2-Sided|95.0|0.804|1.303|||Repeated measures analysis|||CD3+ CD4+, Week 12|
1600973|NCT02799472|2941108|Other||Ratio|0.941||||0.641|2-Sided|95.0|0.721|1.228|||Repeated measures analysis|||CD3+ CD4+, Week 4|
1600974|NCT02799472|2941108|Other||Ratio|1.112||||0.369|2-Sided|95.0|0.876|1.412|||Repeated measures analysis|||CD3+ CD4+, Week 1|
1600975|NCT02799472|2941109|Other||Mean Difference (Net)|-0.021||||0.934|2-Sided|95.0|-0.526|0.484|||Repeated measures analysis|||T Cell B Cell NKL, 12-Week FU|
1600976|NCT02799472|2941109|Other||Mean Difference (Net)|0.087||||0.668|2-Sided|95.0|-0.323|0.498|||Repeated measures analysis|||T Cell B Cell NKL, Week 12|
1600977|NCT02799472|2941109|Other||Mean Difference (Net)|-0.157||||0.534|2-Sided|95.0|-0.668|0.354|||Repeated measures analysis|||T Cell B Cell NKL, Week 4|
1600978|NCT02799472|2941109|Other||Mean Difference (Net)|0.103||||0.569|2-Sided|95.0|-0.263|0.469|||Repeated measures analysis|||T Cell B Cell NKL, Week 1|
1600979|NCT02799472|2941109|Other||Mean Difference (Net)|0.033||||0.569|2-Sided|95.0|-0.084|0.151|||Repeated measures analysis|||CD3+CD8+, 12-Week FU|
1600980|NCT02799472|2941109|Other||Mean Difference (Net)|0.02||||0.677|2-Sided|95.0|-0.076|0.115|||Repeated measures analysis|||CD3+CD8+, Week 12|
1600981|NCT02799472|2941109|Other||Mean Difference (Net)|-0.023||||0.733|2-Sided|95.0|-0.159|0.113|||Repeated measures analysis|||CD3+CD8+, Week 4|
1600982|NCT02799472|2941109|Other||Mean Difference (Net)|0.036||||0.428|2-Sided|95.0|-0.056|0.128|||Repeated measures analysis|||CD3+CD8+, Week 1|
1600983|NCT02799472|2941110|Other||Ratio|1.031||||0.789|2-Sided|95.0|0.818|1.3|||Repeated measures analysis|||CD3+CD4+, 12-Week FU|
1600984|NCT02799472|2941110|Other||Ratio|1.064||||0.573|2-Sided|95.0|0.853|1.328|||Repeated measures analysis|||CD3+CD4+, Week 12|
1600985|NCT02799472|2941110|Other||Ratio|0.907||||0.512|2-Sided|95.0|0.673|1.223|||Repeated measures analysis|||CD3+CD4+, Week 4|
1600986|NCT02799472|2941110|Other||Ratio|1.069||||0.547|2-Sided|95.0|0.855|1.338|||Repeated measures analysis|||CD3+CD4+, Week 1|
1600987|NCT02799472|2941110|Other||Ratio|1.062||||0.567|2-Sided|95.0|0.858|1.316|||Repeated measures analysis|||CD3, 12-Week FU|
1600988|NCT02799472|2941110|Other||Ratio|1.088||||0.413|2-Sided|95.0|0.885|1.336|||Repeated measures analysis|||CD3, Week 12|
1600989|NCT02799472|2941110|Other||Ratio|0.937||||0.632|2-Sided|95.0|0.711|1.234|||Repeated measures analysis|||CD3, Week 4|
1600990|NCT02799472|2941110|Other||Ratio|1.082||||0.437|2-Sided|95.0|0.882|1.328|||Repeated measures analysis|||CD3, Week 1|
1600991|NCT02799472|2941110|Other||Ratio|0.958||||0.831|2-Sided|95.0|0.635|1.443|||Repeated measures analysis|||CD19, 12-Week FU|
1600992|NCT02799472|2941110|Other||Ratio|0.952||||0.724|2-Sided|95.0|0.718|1.262|||Repeated measures analysis|||CD19, Week 12|
1600993|NCT02799472|2941110|Other||Ratio|0.89||||0.51|2-Sided|95.0|0.623|1.271|||Repeated measures analysis|||CD19, Week 4|
1600994|NCT02799472|2941110|Other||Ratio|1.119||||0.383|2-Sided|95.0|0.863|1.45|||Repeated measures analysis|||CD19, Week 1|
1600997|NCT02799472|2941110|Other||Ratio|0.818||||0.188|2-Sided|95.0|0.603|1.109|||Repeated measures analysis|||CD16+CD56+, Week 4|
1600998|NCT02799472|2941110|Other||Ratio|1.037||||0.786|2-Sided|95.0|0.794|1.354|||Repeated measures analysis|||CD16+CD56+, Week 1|
1600999|NCT02799472|2941111|Other||Ratio|1.013||||0.897|2-Sided|95.0|0.822|1.249|||Repeated measures analysis|||Helper/Suppressor, 12-Week FU|
1601000|NCT02799472|2941111|Other||Ratio|1.046||||0.565|2-Sided|95.0|0.895|1.222|||Repeated measures analysis|||Helper/Suppressor, Week 12|
1601001|NCT02799472|2941111|Other||Ratio|0.947||||0.515|2-Sided|95.0|0.801|1.12|||Repeated measures analysis|||Helper/Suppressor, Week 4|
1601002|NCT02799472|2941111|Other||Ratio|0.953||||0.558|2-Sided|95.0|0.809|1.123|||Repeated measures analysis|||Helper/Suppressor, Week 1|
1601003|NCT02799472|2941112|Other||Ratio|1.075||||0.524|2-Sided|95.0|0.855|1.351|||Repeated measures analysis|||MD3C, 12-Week FU|
1601004|NCT02799472|2941112|Other||Ratio|0.979||||0.843|2-Sided|95.0|0.79|1.214|||Repeated measures analysis|||MD3C, Week 12|
1601005|NCT02799472|2941112|Other||Ratio|0.96||||0.691|2-Sided|10.0|0.779|1.182|||Repeated measures analysis|||MD3C, Week 8|
1601006|NCT02799472|2941112|Other||Ratio|0.882||||0.182|2-Sided|95.0|0.733|1.063|||Repeated measures analysis|||MD3C, Week 6|
1601007|NCT02799472|2941112|Other||Ratio|0.943||||0.53|2-Sided|95.0|0.78|1.139|||Repeated measures analysis|||MD3C, Week 4|
1601008|NCT02799472|2941112|Other||Ratio|1.037||||0.644|2-Sided|95.0|0.884|1.218|||Repeated measures analysis|||MD3C, Week 2|
1601009|NCT02799472|2941112|Other||Ratio|1.01||||0.897|2-Sided|95.0|0.868|1.175|||Repeated measures analysis|||MD3C, Week 1|
1601010|NCT02799472|2941112|Other||Ratio|0.778||||0.108|2-Sided|95.0|0.57|1.061|||Repeated measures analysis|||MD2C, 12-Week FU|
1601011|NCT02799472|2941112|Other||Ratio|0.913||||0.467|2-Sided|95.0|0.711|1.173|||Repeated measures analysis|||MD2C, Week 12|
1601012|NCT02799472|2941112|Other||Ratio|0.937||||0.623|2-Sided|95.0|0.719|1.221|||Repeated measures analysis|||MD2C, Week 8|
1601013|NCT02799472|2941112|Other||Ratio|0.919||||0.539|2-Sided|95.0|0.696|1.213|||Repeated measures analysis|||MD2C, Week 6|
1601014|NCT02799472|2941112|Other||Ratio|0.969||||0.794|2-Sided|95.0|0.762|1.233|||Repeated measures analysis|||MD2C, Week 4|
1601015|NCT02799472|2941112|Other||Ratio|0.97||||0.814|2-Sided|95.0|0.744|1.263|||Repeated measures analysis|||MD2C, Week 2|
1601016|NCT02799472|2941112|Other||Ratio|0.981||||0.887|2-Sided|95.0|0.742|1.296|||Repeated measures analysis|||MD2C, Week 1|
1601017|NCT02799472|2941112|Other||Ratio|0.869||||0.401|2-Sided|95.0|0.621|1.217|||Repeated measures analysis|||MD1C, 12-Week FU|
1601018|NCT02799472|2941112|Other||Ratio|0.891||||0.47|2-Sided|95.0|0.647|1.228|||Repeated measures analysis|||MD1C, Week 12|
1601019|NCT02799472|2941112|Other||Ratio|0.799||||0.14|2-Sided|95.0|0.591|1.08|||Repeated measures analysis|||MD1C, Week 8|
1601020|NCT02799472|2941112|Other||Ratio|0.638||||0.004|2-Sided|95.0|0.477|0.855|||Repeated measures analysis|||MD1C, Week 6|
1601021|NCT02799472|2941112|Other||Ratio|0.784||||0.155|2-Sided|95.0|0.558|1.102|||Repeated measures analysis|||MD1C, Week 4|
1601022|NCT02799472|2941112|Other||Ratio|0.883||||0.367|2-Sided|95.0|0.668|1.165|||Repeated measures analysis|||MD1C, Week 2|
1601023|NCT02799472|2941112|Other||Ratio|0.795||||0.047|2-Sided|95.0|0.634|0.997|||Repeated measures analysis|||MD1C, Week 1|
1601024|NCT02799472|2941112|Other||Ratio|1.05||||0.597|2-Sided|95.0|0.87|1.267|||Repeated measures analysis|||MMP-Degraded CRP, 12-Week FU|
1601025|NCT02799472|2941112|Other||Ratio|1.102||||0.242|2-Sided|95.0|0.934|1.3|||Repeated measures analysis|||MMP-Degraded CRP, Week 12|
1601026|NCT02799472|2941112|Other||Ratio|1.113||||0.212|2-Sided|95.0|0.938|1.32|||Repeated measures analysis|||MMP-Degraded CRP, Week 8|
1601027|NCT02799472|2941112|Other||Ratio|0.979||||0.78|2-Sided|95.0|0.842|1.139|||Repeated measures analysis|||MMP-Degraded CRP, Week 6|
1601028|NCT02799472|2941112|Other||Ratio|1.012||||0.866|2-Sided|95.0|0.879|1.165|||Repeated measures analysis|||MMP-Degraded CRP, Week 4|
1601029|NCT02799472|2941112|Other||Ratio|1.031||||0.635|2-Sided|95.0|0.906|1.173|||Repeated measures analysis|||MMP-Degraded CRP, Week 2|
1601030|NCT02799472|2941112|Other||Ratio|1.051||||0.537|2-Sided|95.0|0.895|1.233|||Repeated measures analysis|||MMP-Degraded CRP, Week 1|
1601031|NCT02799472|2941112|Other||Ratio|0.822||||0.544|2-Sided|95.0|0.422|1.602|||Repeated measures analysis|||CMDV, 12-Week FU|
1601032|NCT02799472|2941112|Other||Ratio|0.816||||0.541|2-Sided|95.0|0.417|1.597|||Repeated measures analysis|||CMDV, Week 12|
1601033|NCT02799472|2941112|Other||Ratio|0.817||||0.471|2-Sided|95.0|0.464|1.437|||Repeated measures analysis|||CMDV, Week 8|
1601034|NCT02799472|2941112|Other||Ratio|0.661||||0.227|2-Sided|95.0|0.333|1.31|||Repeated measures analysis|||CMDV, Week 6|
1601035|NCT02799472|2941112|Other||Ratio|1.12||||0.717|2-Sided|95.0|0.597|2.101|||Repeated measures analysis|||CMDV, Week 4|
1601036|NCT02799472|2941112|Other||Ratio|0.87||||0.668|2-Sided|95.0|0.454|1.669|||Repeated measures analysis|||CMDV, Week 2|
1601037|NCT02799472|2941112|Other||Ratio|0.892||||0.681|2-Sided|95.0|0.511|1.56|||Repeated measures analysis|||CMDV, Week 1|
1601038|NCT02799472|2941112|Other||Ratio|0.996||||0.985|2-Sided|95.0|0.662|1.499|||Repeated measures analysis|||ARGS Neo-Epitope, 12-Week FU|
1601039|NCT02799472|2941112|Other||Ratio|1.266||||0.147|2-Sided|95.0|0.916|1.75|||Repeated measures analysis|||ARGS Neo-Epitope, Week 12|
1601040|NCT02799472|2941112|Other||Ratio|1.45||||0.217|2-Sided|95.0|0.795|2.645|||Repeated measures analysis|||ARGS Neo-Epitope, Week 8|
1601041|NCT02799472|2941112|Other||Ratio|1.302||||0.113|2-Sided|95.0|0.936|1.81|||Repeated measures analysis|||ARGS Neo-Epitope, Week 6|
1601042|NCT02799472|2941112|Other||Ratio|1.222||||0.317|2-Sided|95.0|0.817|1.827|||Repeated measures analysis|||ARGS Neo-Epitope, Week 4|
1601043|NCT02799472|2941112|Other||Ratio|1.581||||0.031|2-Sided|95.0|1.046|2.388|||Repeated measures analysis|||ARGS Neo-Epitope, Week 2|
1601044|NCT02799472|2941112|Other||Ratio|1.098||||0.621|2-Sided|95.0|0.75|1.606|||Repeated measures analysis|||ARGS Neo-Epitope, Week 1|
1601045|NCT02799472|2941113|Other||Ratio|1.226||||0.279|2-Sided|95.0|0.837|1.796|||Repeated measures analysis|||MMP-3, 12-Week FU|
1601046|NCT02799472|2941113|Other||Ratio|0.951||||0.745|2-Sided|95.0|0.695|1.301|||Repeated measures analysis|||MMP-3, Week 12|
1601047|NCT02799472|2941113|Other||Ratio|1.16||||0.402|2-Sided|95.0|0.813|1.653|||Repeated measures analysis|||MMP-3, Week 8|
1601048|NCT02799472|2941113|Other||Ratio|0.8||||0.448|2-Sided|95.0|0.443|1.444|||Repeated measures analysis|||MMP-3, Week 6|
1601049|NCT02799472|2941113|Other||Ratio|0.914||||0.354|2-Sided|95.0|0.752|1.11|||Repeated measures analysis|||MMP-3, Week 4|
1601050|NCT02799472|2941113|Other||Ratio|0.959||||0.621|2-Sided|95.0|0.809|1.137|||Repeated measures analysis|||MMP-3, Week 2|
1601051|NCT02799472|2941113|Other||Ratio|0.915||||0.259|2-Sided|95.0|0.781|1.071|||Repeated measures analysis|||MMP-3, Week 1|
1601052|NCT02799472|2941113|Other||Ratio|1.386||||0.102|2-Sided|95.0|0.934|2.057|||Repeated measures analysis|||Chitinase 3 Like 1, 12-Week FU|
1601053|NCT02799472|2941113|Other||Ratio|1.005||||0.985|2-Sided|95.0|0.613|1.645|||Repeated measures analysis|||Chitinase 3 Like 1, Week 12|
1601054|NCT02799472|2941113|Other||Ratio|1.112||||0.608|2-Sided|95.0|0.733|1.687|||Repeated measures analysis|||Chitinase 3 Like 1, Week 8|
1601055|NCT02799472|2941113|Other||Ratio|1.149||||0.473|2-Sided|95.0|0.779|1.694|||Repeated measures analysis|||Chitinase 3 Like 1, Week 6|
1601056|NCT02799472|2941113|Other||Ratio|1.132||||0.533|2-Sided|95.0|0.759|1.69|||Repeated measures analysis|||Chitinase 3 Like 1, Week 4|
1601057|NCT02799472|2941113|Other||Ratio|0.953||||0.782|2-Sided|95.0|0.672|1.352|||Repeated measures analysis|||Chitinase 3 Like 1, Week 2|
1601058|NCT02799472|2941113|Other||Ratio|0.887||||0.463|2-Sided|95.0|0.64|1.231|||Repeated measures analysis|||Chitinase 3 Like 1, Week 1|
1601059|NCT02799472|2941114|Other||Ratio|1.013||||0.929|2-Sided|95.0|0.745|1.378|||Repeated measures analysis|||MDC, 12-Week FU|
1601060|NCT02799472|2941114|Other||Ratio|0.849||||0.142|2-Sided|95.0|0.681|1.059|||Repeated measures analysis|||MDC, Week 12|
1601061|NCT02799472|2941114|Other||Ratio|0.857||||0.157|2-Sided|95.0|0.69|1.064|||Repeated measures analysis|||MDC, Week 8|
1601062|NCT02799472|2941114|Other||Ratio|1.01||||0.915|2-Sided|95.0|0.833|1.225|||Repeated measures analysis|||MDC, Week 6|
1601063|NCT02799472|2941114|Other||Ratio|0.956||||0.637|2-Sided|95.0|0.79|1.158|||Repeated measures analysis|||MDC, Week 4|
1601064|NCT02799472|2941114|Other||Ratio|0.984||||0.851|2-Sided|95.0|0.829|1.168|||Repeated measures analysis|||MDC, Week 2|
1601065|NCT02799472|2941114|Other||Ratio|0.926||||0.195|2-Sided|95.0|0.823|1.042|||Repeated measures analysis|||MDC, Week 1|
1601066|NCT02799472|2941114|Other||Ratio|1.602||||0.216|2-Sided|95.0|0.75|3.423|||Repeated measures analysis|||Interleukin 6, 12-Week FU|
1601067|NCT02799472|2941114|Other||Ratio|1.221||||0.432|2-Sided|95.0|0.734|2.031|||Repeated measures analysis|||Interleukin 6, Week 12|
1601068|NCT02799472|2941114|Other||Ratio|0.684||||0.166|2-Sided|95.0|0.396|1.18|||Repeated measures analysis|||Interleukin 6, Week 8|
1601069|NCT02799472|2941114|Other||Ratio|0.659||||0.147|2-Sided|95.0|0.372|1.167|||Repeated measures analysis|||Interleukin 6, Week 6|
1601070|NCT02799472|2941114|Other||Ratio|0.822||||0.519|2-Sided|95.0|0.447|1.512|||Repeated measures analysis|||Interleukin 6, Week 4|
1601071|NCT02799472|2941114|Other||Ratio|0.72||||0.33|2-Sided|95.0|0.367|1.413|||Repeated measures analysis|||Interleukin 6, Week 2|
1601072|NCT02799472|2941114|Other||Ratio|0.903||||0.751|2-Sided|95.0|0.471|1.729|||Repeated measures analysis|||Interleukin 6, Week 1|
1601073|NCT02799472|2941114|Other||Ratio|1.581||||0.154|2-Sided|95.0|0.832|3.007|||Repeated measures analysis|||CL13, 12-Week FU|
1601074|NCT02799472|2941114|Other||Ratio|1.165||||0.661|2-Sided|95.0|0.573|2.369|||Repeated measures analysis|||CL13, Week 12|
1601075|NCT02799472|2941114|Other||Ratio|1.118||||0.677|2-Sided|95.0|0.651|1.92|||Repeated measures analysis|||CL13, Week 8|
1601076|NCT02799472|2941114|Other||Ratio|1.237||||0.278|2-Sided|95.0|0.836|1.83|||Repeated measures analysis|||CL13, Week 6|
1601077|NCT02799472|2941114|Other||Ratio|1.236||||0.244|2-Sided|95.0|0.859|1.778|||Repeated measures analysis|||CL13, Week 4|
1601078|NCT02799472|2941114|Other||Ratio|1.005||||0.976|2-Sided|95.0|0.726|1.39|||Repeated measures analysis|||CL13, Week 2|
1601079|NCT02799472|2941114|Other||Ratio|0.764||||0.142|2-Sided|95.0|0.53|1.1|||Repeated measures analysis|||CL13, Week 1|
1601080|NCT02799472|2941114|Other||Ratio|0.947||||0.839|2-Sided|95.0|0.548|1.636|||Repeated measures analysis|||CL17, 12-Week FU|
1601081|NCT02799472|2941114|Other||Ratio|0.52||||0.026|2-Sided|95.0|0.294|0.922|||Repeated measures analysis||||
1601082|NCT02799472|2941114|Other||Ratio|0.557||||0.017|2-Sided|95.0|0.348|0.894|||Repeated measures analysis|||CL17, Week 8|
1601083|NCT02799472|2941114|Other||Ratio|0.755||||0.307|2-Sided|95.0|0.435|1.309|||Repeated measures analysis|||CL17, Week 6|
1601084|NCT02799472|2941114|Other||Ratio|0.608||||0.055|2-Sided|95.0|0.365|1.012|||Repeated measures analysis|||CL17, Week 4|
1601085|NCT02799472|2941114|Other||Ratio|0.713||||0.229|2-Sided|95.0|0.407|1.249|||Repeated measures analysis|||CL17, Week 2|
1601086|NCT02799472|2941114|Other||Ratio|0.692||||0.097|2-Sided|95.0|0.445|1.074|||Repeated measures analysis|||CL17, Week 1|
1601087|NCT02799472|2941115|Other||Ratio|1.176||||0.685|2-Sided|95.0|0.519|2.663|||Repeated measures analysis|||Amyloid A, 12-Week FU|
1601088|NCT02799472|2941115|Other||Ratio|0.774||||0.632|2-Sided|95.0|0.261|2.29|||Repeated measures analysis|||Amyloid A, Week 12|
1601089|NCT02799472|2941116|Other||Ratio|1.748||||0.026|2-Sided|95.0|1.076|2.838|||Repeated measures analysis|||S100 CBP A8 and A9, 12-Week FU|
1601090|NCT02799472|2941116|Other||Ratio|1.267||||0.342|2-Sided|95.0|0.769|2.086|||Repeated measures analysis|||S100 CBP A8 and A9, Week 12|
1601091|NCT02799472|2941116|Other||Ratio|1.067||||0.787|2-Sided|95.0|0.659|1.727|||Repeated measures analysis|||S100 CBP A8 and A9, Week 8|
1601092|NCT02799472|2941116|Other||Ratio|0.981||||0.937|2-Sided|95.0|0.595|1.617|||Repeated measures analysis|||S100 CBP A8 and A9, Week 6|
1601093|NCT02799472|2941116|Other||Ratio|1.017||||0.939|2-Sided|95.0|0.649|1.593|||Repeated measures analysis|||S100 CBP A8 and A9, Week 4|
1601094|NCT02799472|2941116|Other||Ratio|0.944||||0.745|2-Sided|95.0|0.662|1.346|||Repeated measures analysis|||S100 CBP A8 and A9, Week 2|
1601095|NCT02799472|2941116|Other||Ratio|0.999||||0.996|2-Sided|95.0|0.699|1.427|||Repeated measures analysis|||S100 CBP A8 and A9, Week 1|
1601096|NCT02799472|2941116|Other||Ratio|0.859||||0.582|2-Sided|95.0|0.491|1.502|||Repeated measures analysis|||14-3-3 ETA Protein, 12-Week FU|
1601097|NCT02799472|2941116|Other||Ratio|0.793||||0.338|2-Sided|95.0|0.488|1.29|||Repeated measures analysis|||14-3-3 ETA Protein, Week 12|
1601098|NCT02799472|2941116|Other||Ratio|0.886||||0.488|2-Sided|95.0|0.623|1.259|||Repeated measures analysis|||14-3-3 ETA Protein, Week 8|
1601099|NCT02799472|2941116|Other||Ratio|0.762||||0.137|2-Sided|95.0|0.531|1.095|||Repeated measures analysis|||14-3-3 ETA Protein, Week 6|
1601100|NCT02799472|2941116|Other||Ratio|0.743||||0.127|2-Sided|95.0|0.505|1.093|||Repeated measures analysis|||14-3-3 ETA Protein, Week 4|
1601101|NCT02799472|2941116|Other||Ratio|1.028||||0.842|2-Sided|95.0|0.776|1.362|||Repeated measures analysis|||14-3-3 ETA Protein, Week 2|
1601102|NCT02799472|2941116|Other||Ratio|0.943||||0.193|2-Sided|95.0|0.861|1.032|||Repeated measures analysis|||14-3-3 ETA Protein, Week 1|
1601103|NCT02799472|2941117|Other||Ratio|1.233||||0.401|2-Sided|95.0|0.742|2.048|||Repeated measures analysis|||GM-CSF - Complex, 12-Week FU|
1601104|NCT02799472|2941117|Other||Ratio|23.249|||<|0.001|2-Sided|95.0|8.579|63.005|||Repeated measures analysis|||GM-CSF - Complex, Week 12|
1601105|NCT02799472|2941117|Other||Ratio|34.635|||<|0.001|2-Sided|95.0|13.69|87.629|||Repeated measures analysis|||GM-CSF - Complex, Week 8|
1601106|NCT02799472|2941117|Other||Ratio|48.336|||<|0.001|2-Sided|95.0|19.341|120.798|||Repeated measures analysis|||GM-CSF - Complex, Week 6|
1601107|NCT02799472|2941117|Other||Ratio|55.772|||<|0.001|2-Sided|95.0|25.646|121.287|||Repeated measures analysis|||GM-CSF - Complex, Week 4|
1601108|NCT02799472|2941117|Other||Ratio|32.36|||<|0.001|2-Sided|95.0|15.828|66.156|||Repeated measures analysis|||GM-CSF - Complex, Week 2|
1601109|NCT02799472|2941117|Other||Ratio|14.201|||<|0.001|2-Sided|95.0|6.251|32.262|||Repeated measures analysis|||GM-CSF - Complex, Week 1|
1601110|NCT02799082|2941122|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1601111|NCT02799082|2941123|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1601112|NCT02799082|2941131|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1601113|NCT02799082|2941132|Superiority or Other||||||<|0.0001||||||"The percentages stated relate to the total number of subjects for the respective week and treatment.~Cochran-Mantel-Haenszel Test stratified by center"|Cochran-Mantel-Haenszel||||
1601114|NCT02799069|2941165|Superiority or Other||Difference to BF-200 ALA|17.3|||||1-Sided|97.5|6.6||||||||
1601115|NCT02799069|2941165|Superiority or Other||Difference to BF-200 ALA|72.0||||0|2-Sided|95.0|59.7|84.2|||Chi-squared||||
1601116|NCT02799069|2941166|Superiority or Other||Difference to BF-200 ALA|59.4||||0|2-Sided|95.0|48.4|70.4|||Chi-squared||||
1601117|NCT02799069|2941166|Non-Inferiority|The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of -15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.|Difference to BF-200 ALA|14.2|||||1-Sided|97.5|6.0||||||||
1601118|NCT02799069|2941167|Superiority||Difference to BF-200 ALA|61.1||||0|2-Sided|95.0|51.2|71.0|||Chi-squared|||"Superiority of BF-200 ALA compared to placebo:~A sample size of 264: 88 patients (BF-200 ALA: placebo) will have a power of more than 90% to establish superiority of BF-200 ALA over placebo, even if very conservative response rates of 65% for the BF-200 ALA group and 40% for placebo are assumed using a chi-square test with continuity correction and a two-sided significance level of 0.05."|
1601119|NCT02799069|2941167|Non-Inferiority|The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of –15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.|Difference to BF-200 ALA|14.0|||||1-Sided|97.5|5.9||||||||
1601120|NCT02798354|2941235|Superiority||Risk Difference (RD)|0.1||||0.922|2-Sided|95.0|-1.8|1.9|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave||
1601121|NCT02798354|2941236|Superiority||Risk Difference (RD)|14.0|||<|0.0001|2-Sided|95.0|10.3|17.7|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave||
1601122|NCT02798354|2941237|Superiority||Risk Difference (RD)|20.1|||<|0.0001|2-Sided|95.0|16.2|24.1|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave||
1601123|NCT02798354|2941238|Superiority||Risk Difference (RD)|26.6|||<|0.0001|2-Sided|95.0|22.4|30.7|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave||
1601124|NCT02798354|2941239|Superiority||Risk Difference (RD)|1.1||||0.302|2-Sided|95.0|-1.0|3.1|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave||
1601125|NCT02798354|2941240|Superiority||Risk Difference (RD)|16.0|||<|0.0001|2-Sided|95.0|12.3|20.0|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave||
1601126|NCT02798354|2941241|Superiority||Risk Difference (RD)|3.9|||<|0.0001|2-Sided|95.0|2.4|5.3|||Mixed Models Analysis||Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave||
1601164|NCT02796651|2941326|Superiority||LSMean difference|0.179|||<|0.001|2-Sided|95.0|0.125|0.233|||Mixed Models Analysis||||
1601127|NCT02797821|2941254|Other||LS Means Difference|-29.492||||0.0239|2-Sided|95.0|-54.723|-4.261||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group [≥ median versus < median], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|Restricted maximum likelihood-based|A statistical adjustment of p-values was not performed.|||
1601128|NCT02797821|2941254|Other||LS Means Difference|-34.047||||0.0128|2-Sided|95.0|-60.171|-7.922||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group [≥ median versus < median], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|Restricted maximum likelihood-based|A statistical adjustment of p-values was not performed.|||
1601129|NCT02797821|2941255|Other||LS Means Difference|-1.193||||0.0008|2-Sided|95.0|-1.805|-0.581||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group [≥median vs < median], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|REML|A fixed sequence testing procedure was used to control the Type I error rate. A statistical adjustment of p-values was not performed.||A fixed sequence testing procedure was performed to compare the 3.0 mg/kg cohort with the 0.5 mg/kg cohort first. The hypothesis testing for the second comparison of the 2.0 mg/kg cohort compared with the 0.5 mg/kg cohort was only performed if the null hypothesis was rejected for the first comparison at a significance level of 0.05 (p-value <0.05). The primary endpoint was met if the null hypothesis was rejected for both comparisons at a significance level of 0.05 (both p-values <0.05).|
1601130|NCT02797821|2941255|Other||Least Squares (LS) Means Difference|-1.88|||<|0.0001|2-Sided|95.0|-2.544|-1.216||REML-based repeated measures mixed model (treatment, visit, sex, Baseline PPi, Baseline weight group [≥median vs < median], and study drug lot assignment as factors) with an unstructured covariance structure for within-participant correlation.|REML|A fixed sequence testing procedure was used to control the Type I error rate. A statistical adjustment of p-values was not performed.||A fixed sequence testing procedure was performed to compare the 3.0 mg/kg cohort with the 0.5 mg/kg cohort first. The hypothesis testing for the second comparison of the 2.0 mg/kg cohort compared with the 0.5 mg/kg cohort was only performed if the null hypothesis was rejected for the previous comparison at a significance level of 0.05 (p-value <0.05). The primary endpoint was met if the null hypothesis was rejected for both comparisons at a significance level of 0.05 (both p-values <0.05).|
1601131|NCT02797678|2941256|Superiority|||||||0.301|||||||paired t-test||||
1601132|NCT02797678|2941259|Superiority|||||||0.061|||||||paired t-test||||
1601133|NCT02797054|2941298|Other|||||||0.21|||||||Chi-squared||||
1601134|NCT02797054|2941299|Other|||||||0.0056|||||||Chi-squared||||
1601135|NCT02797054|2941300|Other|||||||0.0015|||||||Chi-squared||||
1601136|NCT02797054|2941301|Other|||||||0.58|||||||Chi-squared||||
1601137|NCT02797054|2941302|Other|||||||0.895|||||||Chi-squared||||
1601138|NCT02797054|2941303|Other|||||||0.001|||||||Chi-squared||||
1601139|NCT02797054|2941304|Other|||||||0.303|||||||Chi-squared||||
1601140|NCT02797054|2941305|Other|||||||0.069|||||||Chi-squared||||
1601141|NCT02796677|2941320|Superiority||Odds ratio|0.97||||0.8873|2-Sided|95.0|0.59|1.58|||Logistic random-effect model||||
1601142|NCT02796677|2941320|Superiority||Odds ratio|0.96||||0.8714|2-Sided|95.0|0.61|1.51|||Logistic random-effect model||||
1601143|NCT02796677|2941321|Superiority||LS mean difference|0.087|||<|0.0001|2-Sided|95.0|0.052|0.122|||Mixed model for repeated measures||||
1601144|NCT02796677|2941321|Superiority||LS mean difference|0.075|||<|0.0001|2-Sided|95.0|0.043|0.107|||Mixed model for repeated measures||||
1601145|NCT02796677|2941322|Non-Inferiority|Non-inferiority was established by showing that the lower bound of the two-sided 95% confidence interval for change from baseline in morning pre-dose (trough) FEV1 at week 24 when compared AB 400 μg versus TIO 18 μg was higher than -50 mL (non-inferiority limit).|LS mean difference|0.007||||0.6377|2-Sided|95.0|-0.021|0.035|||Mixed model for repeated measures||||
1601146|NCT02796677|2941323|Superiority||LS mean difference|0.055||||0.0009|2-Sided|95.0|0.023|0.088|||Mixed model for repeated measures||||
1601147|NCT02796677|2941324|Superiority||LS mean difference|0.084|||<|0.0001|2-Sided|95.0|0.051|0.117|||Mixed model for repeated measures||||
1601148|NCT02796651|2941325|Superiority||LSMean difference|-0.041||||0.035|2-Sided|95.0|-0.08|-0.003|||Mixed Models Analysis||||
1601149|NCT02796651|2941325|Superiority||LSMean difference|-0.006||||0.75|2-Sided|95.0|-0.045|0.032|||Mixed Models Analysis||||
1601150|NCT02796651|2941325|Superiority||LSMean difference|0.035||||0.074|2-Sided|95.0|-0.003|0.074|||Mixed Models Analysis||||
1601151|NCT02796651|2941325|Superiority||LSMean difference|-0.016||||0.403|2-Sided|95.0|-0.053|0.022|||Mixed Models Analysis||||
1601152|NCT02796651|2941325|Superiority||LSMean difference|0.025||||0.209|2-Sided|95.0|-0.014|0.065|||Mixed Models Analysis||||
1601153|NCT02796651|2941325|Superiority||LSMean difference|-0.01||||0.615|2-Sided|95.0|-0.048|0.028|||Mixed Models Analysis||||
1601154|NCT02796651|2941325|Superiority||LSMean difference|0.059||||0.075|2-Sided|95.0|-0.006|0.123|||Mixed Models Analysis||||
1601155|NCT02796651|2941325|Superiority||LSMean difference|0.1||||0.004|2-Sided|95.0|0.032|0.168|||Mixed Models Analysis||||
1601156|NCT02796651|2941325|Superiority||LSMean difference|0.065||||0.054|2-Sided|95.0|-0.001|0.131|||Mixed Models Analysis||||
1601157|NCT02796651|2941325|Superiority||LSMean difference|0.075||||0.027|2-Sided|95.0|0.008|0.141|||Mixed Models Analysis||||
1601158|NCT02796651|2941326|Superiority||LSMean difference|-0.039||||0.017|2-Sided|95.0|-0.072|-0.007|||Mixed Models Analysis||||
1601159|NCT02796651|2941326|Superiority||LSMean difference|0.009||||0.567|2-Sided|95.0|-0.022|0.041|||Mixed Models Analysis||||
1601160|NCT02796651|2941326|Superiority||LSMean difference|0.049||||0.004|2-Sided|95.0|0.016|0.081|||Mixed Models Analysis||||
1601161|NCT02796651|2941326|Superiority||LSMean difference|0.02||||0.206|2-Sided|95.0|-0.011|0.051|||Mixed Models Analysis||||
1601162|NCT02796651|2941326|Superiority||LSMean difference|0.06|||<|0.001|2-Sided|95.0|0.027|0.092|||Mixed Models Analysis||||
1601163|NCT02796651|2941326|Superiority||LSMean difference|0.011|||<|0.488|2-Sided|95.0|-0.02|0.042|||Mixed Models Analysis||||
1601165|NCT02796651|2941326|Superiority||LSMean difference|0.219|||<|0.001|2-Sided|95.0|0.163|0.274|||Mixed Models Analysis||||
1601166|NCT02796651|2941326|Superiority||LSMean difference|0.17|||<|0.001|2-Sided|95.0|0.116|0.224|||Mixed Models Analysis||||
1601167|NCT02796651|2941326|Superiority||LSMean difference|0.159|||<|0.001|2-Sided|95.0|0.105|0.213|||Mixed Models Analysis||||
1601168|NCT02796651|2941327|Superiority||LSMean difference|0.051|||<|0.001|2-Sided|95.0|0.025|0.076|||Mixed Models Analysis||||
1601169|NCT02796651|2941327|Superiority||LSMean difference|0.041|||<|0.002|2-Sided|95.0|0.015|0.068|||Mixed Models Analysis||||
1601170|NCT02796651|2941327|Superiority||LSMean difference|-0.009|||<|0.469|2-Sided|95.0|-0.035|0.016|||Mixed Models Analysis||||
1601171|NCT02796651|2941327|Superiority||LSMean difference|0.098|||<|0.001|2-Sided|95.0|0.073|0.123|||Mixed Models Analysis||||
1601172|NCT02796651|2941327|Superiority||LSMean difference|0.047|||<|0.001|2-Sided|95.0|0.023|0.071|||Mixed Models Analysis||||
1601173|NCT02796651|2941327|Superiority||LSMean difference|0.057|||<|0.001|2-Sided|95.0|0.031|0.082|||Mixed Models Analysis||||
1601174|NCT02796651|2941327|Superiority||LSMean difference|0.135|||<|0.001|2-Sided|95.0|0.109|0.161|||Mixed Models Analysis||||
1601175|NCT02796651|2941327|Superiority||LSMean difference|0.084|||<|0.001|2-Sided|95.0|0.059|0.11|||Mixed Models Analysis||||
1601176|NCT02796651|2941327|Superiority||LSMean difference|0.094|||<|0.001|2-Sided|95.0|0.068|0.119|||Mixed Models Analysis||||
1601177|NCT02796651|2941327|Superiority||LSMean difference|0.037|||<|0.004|2-Sided|95.0|0.012|0.062|||Mixed Models Analysis||||
1601178|NCT02796651|2941327|Superiority||LSMean difference|0.265|||<|0.001|2-Sided|95.0|0.226|0.304|||Mixed Models Analysis||||
1601179|NCT02796651|2941327|Superiority||LSMean difference|0.214|||<|0.001|2-Sided|95.0|0.176|0.253|||Mixed Models Analysis||||
1601180|NCT02796651|2941327|Superiority||LSMean difference|0.224|||<|0.001|2-Sided|95.0|0.184|0.263|||Mixed Models Analysis||||
1601181|NCT02796651|2941327|Superiority||LSMean difference|0.167|||<|0.001|2-Sided|95.0|0.128|0.206|||Mixed Models Analysis||||
1601182|NCT02796651|2941327|Superiority||LSMean difference|0.13|||<|0.001|2-Sided|95.0|0.091|0.169|||Mixed Models Analysis||||
1601183|NCT02796651|2941328|Superiority||LSMean difference|-0.039||||0.014|2-Sided|95.0|-0.071|-0.008|||Mixed Models Analysis||||
1601184|NCT02796651|2941328|Superiority||LSMean difference|0.005||||0.756|2-Sided|95.0|-0.026|0.036|||Mixed Models Analysis||||
1601185|NCT02796651|2941328|Superiority||LSMean difference|0.044||||0.006|2-Sided|95.0|0.013|0.076|||Mixed Models Analysis||||
1601186|NCT02796651|2941328|Superiority||LSMean difference|0.014||||0.365|2-Sided|95.0|-0.016|0.044|||Mixed Models Analysis||||
1601187|NCT02796651|2941328|Superiority||LSMean difference|0.053||||0.001|2-Sided|95.0|0.021|0.085|||Mixed Models Analysis||||
1601188|NCT02796651|2941328|Superiority||LSMean difference|0.009||||0.556|2-Sided|95.0|-0.021|0.039|||Mixed Models Analysis||||
1601189|NCT02796651|2941328|Superiority||LSMean difference|0.122|||<|0.001|2-Sided|95.0|0.069|0.175|||Mixed Models Analysis||||
1601190|NCT02796651|2941328|Superiority||LSMean difference|0.162|||<|0.001|2-Sided|95.0|0.107|0.216|||Mixed Models Analysis||||
1601191|NCT02796651|2941328|Superiority||LSMean difference|0.117|||<|0.001|2-Sided|95.0|0.064|0.171|||Mixed Models Analysis||||
1601192|NCT02796651|2941328|Superiority||LSMean difference|0.108|||<|0.001|2-Sided|95.0|0.055|0.161|||Mixed Models Analysis||||
1601193|NCT02796092|2941338|Superiority or Other|||||||0.095|||||||Fisher Exact||||
1601194|NCT02796092|2941340|Superiority or Other|||||||0.0499|||||||Chi-squared||||
1601195|NCT02796092|2941341|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1601196|NCT02796092|2941342|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1601197|NCT02796092|2941343|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1601198|NCT02796092|2941344|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1601199|NCT02796092|2941345|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1601200|NCT02796092|2941346|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1601201|NCT02796092|2941347|Superiority or Other|||||||0.061|||||||Wilcoxon (Mann-Whitney)||||
1601202|NCT02796092|2941348|Superiority or Other||||||>|0.999|||||||Fisher Exact||||
1601203|NCT02796092|2941349|Superiority or Other||||||>|0.999|||||||Fisher Exact||||
1601204|NCT02796092|2941350|Superiority or Other|||||||0.3|||||||Fisher Exact||||
1601205|NCT02796092|2941351|Superiority or Other||||||>|0.999|||||||Fisher Exact|||Assuming that both methods were equally effective, we did not use this primary outcome to calculate sample size. It was determined using our own retrospective data of patients from the year 2013, comparing the means of the procedure total time with both methods (41.20±4.66 vs 34.99±4.43 minutes). Ten patients in each group were considered enough to detect the above-mentioned differences with a α-error of 0.05 and 80% power, using a two-sided test.|
1601206|NCT02795832|2941355|Superiority||Mean Difference (Net)|-2.66|Standard Error of the Mean|4.521||0.2812|2-Sided|90.0|-10.4|5.09||The 1-sided p-value tests if the ZPL-5212372 LS mean is < placebo LS mean.|Shapiro-Wilkes test||||
1601207|NCT02795832|2941356|Superiority||Odds Ratio (OR)|2.43||||0.2455|2-Sided|95.0|0.45|13.26|||t-test, 1 sided||||
1601208|NCT02795832|2941357|Superiority||Mean Difference (Net)|0.07|Standard Deviation|1.22||0.5233|2-Sided|90.0|-2.02|2.16|||Shapiro-Wilkes test||||
1601209|NCT02795832|2941358|Superiority||Odds Ratio (OR)|0.45||||0.5|2-Sided|95.0|0.01|19.2||Results for the ZPL-5212372 and placebo groups are estimated adjusted LS means from the fitted model.|Shapiro-Wilkes test|The p-value tests if the residuals are normally distributed.|||
1601210|NCT02795832|2941359|Superiority|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Odds Ratio (OR)|2.0||||0.3|2-Sided|90.0|0.24|999.0||The 1-sided p-value tests if the ZPL-5212372 LS mean is < placebo LS mean.|ANCOVA|||EASI-75|
1601601|NCT02784106|2942055|Superiority||Difference in Proportion of Responders|0.1|||||2-Sided|80.0|-0.07|0.25|||||||
1601211|NCT02795832|2941359|Superiority|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Odds Ratio (OR)|1.55||||0.4789|2-Sided|90.0|0.28|10.75||The 1-sided p-value tests if the ZPL-5212372 LS mean is < placebo LS mean.|ANCOVA|||EASI 50|
1601212|NCT02795832|2941360|Superiority|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|0.05||||0.5016|2-Sided|90.0|-21.24|21.34|||ANCOVA|||Day 15|
1601213|NCT02795832|2941360|Superiority|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-6.01||||0.2765|2-Sided|90.0|-23.08|11.06||The 1-sided p-value tests if the ZPL-5212372 LS mean is < the placebo LS mean.|ANCOVA|||Day 10|
1601214|NCT02795832|2941360|Superiority|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-5.95||||0.2765|2-Sided|90.0|-22.85|10.95||The 1-sided p-value tests if the ZPL-5212372 LS mean is < the placebo LS mean.|ANCOVA|||Day 8|
1601215|NCT02795832|2941360|Superiority|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-11.72||||0.1284|2-Sided|90.0|-28.85|5.51||The 1-sided p-value tests if the ZPL-5212372 LS mean is < the placebo LS mean.|ANCOVA|||Day 5|
1601216|NCT02795832|2941361|Superiority|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-37.6|Standard Error of the Mean|18.748||0.0275|2-Sided|90.0|-69.53|-5.66||The 1-sided p-value tests if the ZPL-5212372 LS mean is < the placebo LS mean.|ANCOVA|||Worst case imputation|
1601217|NCT02795832|2941361|Superiority|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-18.27|Standard Error of the Mean|13.138||0.0878|2-Sided|90.0|-40.65|4.11||The 1-sided p-value tests if the ZPL-5212372 LS mean is < the placebo LS mean.|ANCOVA|||Last observation carried forward|
1601218|NCT02795832|2941361|Superiority|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|-3.01|Standard Error of the Mean|12.964||0.4082|2-Sided|90.0|-24.39|18.36||The 1-sided p-value tests if the ZPL-5212372 LS mean is < the placebo LS mean.|ANCOVA|||Multiple imputations|
1601219|NCT02795832|2941361|Superiority|ANCOVA model was fitted with percent change from baseline to Week 2 in EASI score as the dependent variable. Explanatory variables fitted were: treatment group (ZPL-5212372, placebo) and baseline EASI score as a continuous variable.|Mean Difference (Net)|0.05|Standard Error of the Mean|12.441||0.5016|2-Sided|90.0|-21.24|21.34||The 1-sided p-value tests if the ZPL-5212372 LS mean is < the placebo LS mean.|ANCOVA|||Observed case|
1601220|NCT02795767|2941388|Other||ABR Ratio|0.1|||||2-Sided|95.0|0.051|0.21|||||Emicizumab QW is the numerator and Prophylactic/Episodic Bypassing Agent is the denominator.||
1601221|NCT02795767|2941389|Other||ABR Ratio|0.01|||||2-Sided|95.0|0.006|0.023|||||Emicizumab QW is the numerator and Prophylactic/Episodic Bypassing Agent is the denominator.||
1601222|NCT02794974|2941420|Superiority||Odds Ratio|1.88||||0.695|2-Sided|95.0|0.37|9.45|||Odds Ratio||||
1601223|NCT02794974|2941421|Superiority||Odds Ratio|2.5||||0.44|2-Sided|95.0|0.49|12.77|||Odds Ratio||||
1601224|NCT02794974|2941422|Superiority||Odds Ratio|4.5||||0.209|2-Sided|95.0|0.63|32.2|||Odds Ratio||||
1601225|NCT02794974|2941423|Superiority|||||||0.018|||||||Wilcoxon (Mann-Whitney)||||
1601226|NCT02794974|2941424|Superiority|||||||0.236|||||||Fisher Exact||||
1601227|NCT02794870|2941428|Superiority||||||<|0.001||||||The threshold for statistical significance is 0.05.|Log Rank||||
1601228|NCT02794870|2941429|Superiority||||||<|0.01||||||Due to unequal sample sizes, a 1-sided Fisher's exact test was used to test the hypothesis that proportions of greater than or equal to 4-fold rises were higher in the vaccinated than in the placebo group. Statistical significance level was 0.05.|Fisher Exact||||
1601229|NCT02794870|2941434|Other||% placebo with unsolicited AEs|18.0|||||2-Sided|90.0|3.0|47.0|||||||
1601230|NCT02794870|2941434|Other||% vaccinees with unsolicited AEs|35.0|||||2-Sided|90.0|18.0|56.0|||||||
1601231|NCT02794870|2941435|Other||% placebo recipients with solicited AEs|27.0|||||2-Sided|90.0|8.0|56.0|||||||
1601232|NCT02794870|2941435|Other||% vaccine recipients with solicited AEs|60.0|||||2-Sided|90.0|39.0|78.0|||||||
1601233|NCT02794480|2941442|Superiority||Odds Ratio (OR)|4.16||||0.011|2-Sided|95.0|1.59||The upper limit is infinity.|Exact odds ratio calculated using exact conditional logistic regression adjusted for treatment and treatment period.|Conditional Logistic Regression||ELLIPTA versus AZ MDI||
1601234|NCT02794480|2941442|Superiority||Odds Ratio (OR)|5.94|||<|0.001|2-Sided|95.0|2.42||The upper limit is infinity.|Exact odds ratio calculated using exact conditional logistic regression adjusted for treatment and treatment period.|Conditional Logistic Regression||ELLIPTA versus GSK MDI||
1601235|NCT02794480|2941447|Superiority|||||||0.007||||||ELLIPTA versus AZ MDI|Mainland-Gart test||||Mainland-Gart test is favorable over the McNemar test for matched pairs as the latter is only valid in case of no period effects.
1601236|NCT02794480|2941447|Superiority||||||<|0.001||||||ELLIPTA versus GSK MDI|Mainland-Gart test||||Mainland-Gart test is favorable over the McNemar test for matched pairs as the latter is only valid in case of no period effects.
1601237|NCT02793817|2941468|Superiority||Mean Difference (Final Values)|-0.15||||0.0169|2-Sided|95.0|-0.28|-0.03||P-values have no inferential value for post hoc evaluations.|Chi-squared|Without adjustments for any covariates.|Estimated Value is the between-group difference for change from BL||
1602240|NCT02756689|2943620|Superiority|||||||0.96|||||||Wilcoxon (Mann-Whitney)||||
1601238|NCT02793817|2941469|Superiority||Mean Difference (Final Values)|-0.24||||0.0005|2-Sided|95.0|-0.38|-0.11||P-values have no inferential value for post hoc evaluations.|Chi-squared|Without any adjustment for covariates|Estimated Value is the between-group difference in change from BL||
1601239|NCT02793817|2941470|Superiority||Mean Difference (Final Values)|-0.18||||0.0078|2-Sided|95.0|-0.31|-0.05|||Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for change from BL.|P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.|
1601240|NCT02793817|2941471|Superiority||Difference in percentage of responders|19.0|||<|0.0001|2-Sided|95.0|11.0|26.9||P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.||
1601241|NCT02793817|2941472|Superiority||Difference in percentage of responders|17.1|||<|0.0001|2-Sided|95.0|9.1|25.0||P-value was based on a 2-sided chi-squared test (unadjusted) wherein the a priori significance level was 0.0167 for each secondary endpoint. Overall alpha for all secondary endpoints was controlled at 0.05.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.||
1601242|NCT02793817|2941473|Superiority||Difference in percentage of responders|20.0|||<|0.0001|2-Sided|95.0|11.6|28.4||To account for multiplicity, a step-down closed testing procedure was applied, whereby inference for a test in the pre-defined hierarchy was dependent upon statistical significance having been demonstrated for the previous test in the hierarchy.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|P-values were based on 2-sided chi-squared test (unadjusted), wherein a priori significance level was 0.05|
1601243|NCT02793817|2941474|Superiority||Difference in percentage of responders|8.3||||0.0105|2-Sided|95.0|2.0|14.7||To account for multiplicity, a step-down testing procedure was applied, whereby inference for a test in the pre-defined hierarchy was dependent upon statistical significance having been demonstrated for the previous test in the hierarchy.|Chi-squared|Without adjustment for any covariates|Estimated Value is the between-group difference for % of responders and is expressed as a percentage.|P-values were based on 2-sided chi-squared tests (unadjusted) wherein the a priori significance level was 0.05.|
1601244|NCT02793232|2941481|Superiority||Percent change from baseline|-85.365|Standard Error of the Mean|0.0653|<|0.0001|2-Sided|80.0|-86.57|-84.05|||Mixed Models Analysis|||Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601245|NCT02793232|2941481|Superiority||Percent change from baseline|-78.408|Standard Error of the Mean|0.0602|<|0.0001|2-Sided|80.0|-80.06|-76.62|||Mixed Models Analysis|||Abeta total: General linear model with treatment, as the fixed effect and loge(baseline) as covariate|
1601246|NCT02793232|2941481|Superiority||Percent change from baseline|-83.381|Standard Error of the Mean|0.0733|<|0.0001|2-Sided|80.0|-84.92|-81.69|||Mixed Models Analysis|||sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601247|NCT02793232|2941481|Superiority||Percent change from baseline|-80.164|Standard Error of the Mean|0.0668|<|0.0001|2-Sided|80.0|-81.84|-78.33|||Mixed Models Analysis|||sAPP-beta: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601248|NCT02793232|2941481|Superiority||Percent change from baseline|98.049|Standard Error of the Mean|0.0897|<|0.0001|2-Sided|80.0|75.92|122.96|||Mixed Models Analysis|||sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601249|NCT02793232|2941481|Superiority||Percent change from baseline|72.893|Standard Error of the Mean|0.0809|<|0.0001|2-Sided|80.0|55.37|92.4|||Mixed Models Analysis|||sAPP-alpha: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601250|NCT02793232|2941481|Superiority||Percent change from baseline|-84.985|Standard Error of the Mean|0.0715|<|0.0001|2-Sided|80.0|-86.34|-83.5|||Mixed Models Analysis|||ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601251|NCT02793232|2941481|Superiority||Percent change from baseline|-79.648|Standard Error of the Mean|0.0664|<|0.0001|2-Sided|80.0|-81.36|-77.78|||Mixed Models Analysis|||ABeta x-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601252|NCT02793232|2941481|Superiority||Percent change from baseline|-86.28|Standard Error of the Mean|0.0899|<|0.0001|2-Sided|80.0|-87.82|-84.55|||Mixed Models Analysis|||ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601253|NCT02793232|2941481|Superiority||Percent change from baseline|-78.936|Standard Error of the Mean|0.0824|<|0.0001|2-Sided|80.0|-81.11|-76.52|||Mixed Models Analysis|||ABeta x-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601254|NCT02793232|2941481|Superiority||Percent change from baseline|-88.711|Standard Error of the Mean|0.0963|<|0.0001|2-Sided|80.0|-90.06|-87.18|||Mixed Models Analysis|||ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601255|NCT02793232|2941481|Superiority||Percent change from baseline|-79.465|Standard Error of the Mean|0.087|<|0.0001|2-Sided|80.0|-81.69|-76.96|||Mixed Models Analysis|||ABeta x-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601256|NCT02793232|2941481|Superiority||Percent change from baseline|-92.87|Standard Error of the Mean|0.1114|<|0.0001|2-Sided|80.0|-93.85|-91.74|||Mixed Models Analysis|||ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601257|NCT02793232|2941481|Superiority||Percent change from baseline|-84.814|Standard Error of the Mean|0.0971|<|0.0001|2-Sided|80.0|-86.64|-82.74|||Mixed Models Analysis|||ABeta 1-42: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601258|NCT02793232|2941481|Superiority||Percent change from baseline|-92.138|Standard Error of the Mean|0.1041|<|0.0001|2-Sided|80.0|-93.15|-90.98|||Mixed Models Analysis|||ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601259|NCT02793232|2941481|Superiority||Percent change from baseline|-83.83|Standard Error of the Mean|0.0905|<|0.0001|2-Sided|80.0|-85.65|-81.78|||Mixed Models Analysis|||ABeta 1-40: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601889|NCT02766023|2943024|Superiority||Risk Difference (RD)|0.03||||0.643|2-Sided|95.0|-0.08|0.15|||Chi-squared|||Analysis is for self-reported compliance|
1601260|NCT02793232|2941481|Superiority||Percent change from baseline|-87.403|Standard Error of the Mean|0.0887|<|0.0001|2-Sided|80.0|-88.8|-85.84|||Mixed Models Analysis|||ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601261|NCT02793232|2941481|Superiority||Percent change from baseline|-79.456|Standard Error of the Mean|0.0819|<|0.0001|2-Sided|80.0|-81.56|-77.11|||Mixed Models Analysis|||ABeta 1-38: General linear model with treatment, as the fixed effect and loge(baseline) as covariate.|
1601262|NCT02792699|2941597|Other||Risk Difference (RD)|0.0187|||||2-Sided|90.0|-0.061|0.0984|||||Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.||
1601263|NCT02792699|2941597|Other||Risk Difference (RD)|-0.0245|||||2-Sided|90.0|-0.1083|0.0593|||||Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.||
1601264|NCT02792699|2941598|Other||LS Mean Difference|-3.096|||||2-Sided|90.0|-9.883|3.691||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601265|NCT02792699|2941598|Other||LS Mean Difference|-6.629|||||2-Sided|90.0|-13.455|0.197||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601266|NCT02792699|2941598|Other||LS Mean Difference|-0.036|||||2-Sided|90.0|-6.497|6.424||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601267|NCT02792699|2941598|Other||LS Mean Difference|-2.207|||||2-Sided|90.0|-8.562|1.417||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601268|NCT02792699|2941598|Other||LS Mean Difference|0.73|||||2-Sided|90.0|-5.691|7.15||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601269|NCT02792699|2941598|Other||LS Mean Difference|-1.32|||||2-Sided|90.0|-7.62|4.979||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601270|NCT02792699|2941598|Other||LS Mean Difference|-2.06|||||2-Sided|90.0|-8.052|3.933||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601271|NCT02792699|2941598|Other||LS Mean Difference|-8.224|||||2-Sided|90.0|-14.102|-2.346||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601272|NCT02792699|2941598|Other||LS Mean Difference|0.544|||||2-Sided|90.0|-5.185|6.274||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601273|NCT02792699|2941598|Other||LS Mean Difference|-1.999|||||2-Sided|90.0|-7.673|3.675||||||Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601274|NCT02792699|2941599|Other||Risk Difference (RD)|0.0277|||||2-Sided|90.0|-0.0804|0.1357||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601275|NCT02792699|2941599|Other||Risk Ratio (RR)|1.1449|||||2-Sided|90.0|0.7601|1.7246||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601276|NCT02792699|2941599|Other||Risk Difference (RD)|-0.0908|||||2-Sided|90.0|-0.211|0.0294||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601277|NCT02792699|2941599|Other||Risk Ratio (RR)|0.7027|||||2-Sided|90.0|0.493|1.0017||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601278|NCT02792699|2941599|Other||Risk Difference (RD)|0.0752|||||2-Sided|90.0|-0.0297|0.1802||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601279|NCT02792699|2941599|Other||Risk Ratio (RR)|1.1831|||||2-Sided|90.0|0.7833|1.787||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601280|NCT02792699|2941599|Other||Risk Difference (RD)|0.0375|||||2-Sided|90.0|-0.0707|0.1456||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601281|NCT02792699|2941599|Other||Risk Ratio (RR)|0.9798|||||2-Sided|90.0|0.6675|1.4384||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601406|NCT02790788|2941739|Superiority||Median Difference (Net)|0.013|Standard Error of the Mean|0.039||0.75|2-Sided|95.0|-0.066|0.091|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 72 HOURS AFTER ROSC|
1601282|NCT02792699|2941599|Other||Risk Difference (RD)|0.0244|||||2-Sided|90.0|-0.063|0.1119||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601283|NCT02792699|2941599|Other||Risk Ratio (RR)|1.112|||||2-Sided|90.0|0.6722|1.8398||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601284|NCT02792699|2941599|Other||Risk Difference (RD)|0.0156|||||2-Sided|90.0|-0.078|0.1092||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601285|NCT02792699|2941599|Other||Risk Ratio (RR)|0.9254|||||2-Sided|90.0|0.5772|1.4838||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601286|NCT02792699|2941599|Other||Risk Difference (RD)|-0.0417|||||2-Sided|90.0|-1237.0|0.0403||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601287|NCT02792699|2941599|Other||Risk Ratio (RR)|0.7857|||||2-Sided|90.0|0.445|1.3874||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601288|NCT02792699|2941599|Other||Risk Difference (RD)|-0.0569|||||2-Sided|90.0|-0.1448|0.031||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601289|NCT02792699|2941599|Other||Risk Ratio (RR)|0.6346|||||2-Sided|90.0|0.3704|1.0872||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601290|NCT02792699|2941599|Other||Risk Difference (RD)|-0.0327|||||2-Sided|90.0|-0.0962|0.0308||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601291|NCT02792699|2941599|Other||Risk Ratio (RR)|0.7476|||||2-Sided|90.0|0.3383|1.6519||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601292|NCT02792699|2941599|Other||Risk Difference (RD)|-0.0574|||||2-Sided|90.0|-0.1285|0.0136||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601293|NCT02792699|2941599|Other||Risk Ratio (RR)|0.5926|||||2-Sided|90.0|0.2818|1.2462||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601294|NCT02792699|2941600|Other||Risk Difference (RD)|0.0141|||||2-Sided|90.0|-0.1021|0.1303||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601295|NCT02792699|2941600|Other||Risk Ratio (RR)|1.0548|||||2-Sided|90.0|0.8351|1.3321||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601296|NCT02792699|2941600|Other||Risk Difference (RD)|-0.0781|||||2-Sided|90.0|-0.2014|0.0452||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601297|NCT02792699|2941600|Other||Risk Ratio (RR)|0.8376|||||2-Sided|90.0|0.6807|1.0307||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601298|NCT02792699|2941600|Other||Risk Difference (RD)|0.0288|||||2-Sided|90.0|-0.0827|0.1402||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601299|NCT02792699|2941600|Other||Risk Ratio (RR)|1.1191|||||2-Sided|90.0|0.878|1.4264||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601300|NCT02792699|2941600|Other||Risk Difference (RD)|-0.0863|||||2-Sided|90.0|-0.2029|0.0302||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601301|NCT02792699|2941600|Other||Risk Ratio (RR)|0.8373|||||2-Sided|90.0|0.6797|1.0316||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601302|NCT02792699|2941600|Other||Risk Difference (RD)|0.0039|||||2-Sided|90.0|-0.1056|0.1135||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601748|NCT02783573|2942107|Superiority||LS Mean Difference (Final Values)|-0.52|Standard Error of the Mean|1.19||0.661|2-Sided|95.0|-2.889|1.843|||Mixed Models Analysis||||
1601303|NCT02792699|2941600|Other||Risk Ratio (RR)|1.0029|||||2-Sided|90.0|0.756|1.3305||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601304|NCT02792699|2941600|Other||Risk Difference (RD)|0.002|||||2-Sided|90.0|-0.1081|0.1122||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601305|NCT02792699|2941600|Other||Risk Ratio (RR)|0.9612|||||2-Sided|90.0|0.7273|1.2705||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601306|NCT02792699|2941600|Other||Risk Difference (RD)|0.0441|||||2-Sided|90.0|-0.0626|0.1508||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601307|NCT02792699|2941600|Other||Risk Ratio (RR)|1.0882|||||2-Sided|90.0|0.7829|1.5127||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601308|NCT02792699|2941600|Other||Risk Difference (RD)|-0.1109|||||2-Sided|90.0|-0.2231|0.0013||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601309|NCT02792699|2941600|Other||Risk Ratio (RR)|0.7095|||||2-Sided|90.0|0.5387|0.9346||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601310|NCT02792699|2941600|Other||Risk Difference (RD)|0.0201|||||2-Sided|90.0|-0.0803|0.1205||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601311|NCT02792699|2941600|Other||Risk Ratio (RR)|1.0868|||||2-Sided|90.0|0.7328|1.6119||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601312|NCT02792699|2941600|Other||Risk Difference (RD)|-0.0181|||||2-Sided|90.0|-0.1209|0.0847||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601313|NCT02792699|2941600|Other||Risk Ratio (RR)|0.9256|||||2-Sided|90.0|0.64|1.3388||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601314|NCT02792699|2941601|Other||Risk Difference (RD)|-0.1037|||||2-Sided|90.0|-0.2066|-0.0007||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601315|NCT02792699|2941601|Other||Risk Ratio (RR)|0.8804|||||2-Sided|90.0|0.7587|1.0215||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601316|NCT02792699|2941601|Other||Risk Difference (RD)|-0.2004|||||2-Sided|90.0|-0.3066|-0.0941||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601317|NCT02792699|2941601|Other||Risk Ratio (RR)|0.7862|||||2-Sided|90.0|0.6722|0.9196||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601318|NCT02792699|2941601|Other||Risk Difference (RD)|0.0008|||||2-Sided|90.0|-0.1038|0.1054||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601319|NCT02792699|2941601|Other||Risk Ratio (RR)|0.9982|||||2-Sided|90.0|0.8585|1.1605||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601320|NCT02792699|2941601|Other||Risk Difference (RD)|-0.0776|||||2-Sided|90.0|-0.1789|0.0237||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601321|NCT02792699|2941601|Other||Risk Ratio (RR)|0.8848|||||2-Sided|90.0|0.7759|1.0091||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601322|NCT02792699|2941601|Other||Risk Difference (RD)|0.0561|||||2-Sided|90.0|-0.0493|0.1615||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601323|NCT02792699|2941601|Other||Risk Ratio (RR)|1.0793|||||2-Sided|90.0|0.9244|1.2601||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601749|NCT02783573|2942107|Superiority||LS Mean Difference (Final Values)|1.23|Standard Error of the Mean|1.14||0.285|2-Sided|95.0|-1.045|3.499|||Mixed Models Analysis||||
1601324|NCT02792699|2941601|Other||Risk Difference (RD)|0.0199|||||2-Sided|90.0|-0.0835|0.1234||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601325|NCT02792699|2941601|Other||Risk Ratio (RR)|1.0102|||||2-Sided|90.0|0.8743|1.1671||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601326|NCT02792699|2941601|Other||Risk Difference (RD)|0.0348|||||2-Sided|90.0|-0.0758|0.1454||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601327|NCT02792699|2941601|Other||Risk Ratio (RR)|1.0426|||||2-Sided|90.0|0.877|1.2394||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601328|NCT02792699|2941601|Other||Risk Difference (RD)|-0.0794|||||2-Sided|90.0|-0.1834|0.0247||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601329|NCT02792699|2941601|Other||Risk Ratio (RR)|0.878|||||2-Sided|90.0|0.7573|1.0179||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601330|NCT02792699|2941601|Other||Risk Difference (RD)|0.0246|||||2-Sided|90.0|-0.091|0.1402||||||Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601331|NCT02792699|2941601|Other||Risk Ratio (RR)|1.0392|||||2-Sided|90.0|0.8436|1.2801||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601332|NCT02792699|2941601|Other||Risk Difference (RD)|-0.036|||||2-Sided|90.0|-0.1495|0.0775||||||Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601333|NCT02792699|2941601|Other||Risk Ratio (RR)|0.9339|||||2-Sided|90.0|0.7696|1.1332||||||Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.|
1601334|NCT02792699|2941602|Other||LS Mean Difference|0.08|||||2-Sided|90.0|-0.216|0.376||||||Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601335|NCT02792699|2941602|Other||LS Mean Difference|0.262|||||2-Sided|90.0|-0.04|0.564||||||Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601336|NCT02792699|2941602|Other||LS Mean Difference|0.16|||||2-Sided|90.0|-0.135|0.455||||||Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601337|NCT02792699|2941602|Other||LS Mean Difference|0.255|||||2-Sided|90.0|-0.04|0.55||||||Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601338|NCT02792699|2941602|Other||LS Mean Difference|0.27|||||2-Sided|90.0|0.0|0.539||||||Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601339|NCT02792699|2941602|Other||LS Mean Difference|0.502|||||2-Sided|90.0|0.233|0.772||||||Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601340|NCT02792699|2941602|Other||LS Mean Difference|-0.147|||||2-Sided|90.0|-0.411|0.117||||||Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601341|NCT02792699|2941602|Other||LS Mean Difference|0.064|||||2-Sided|90.0|-0.203|0.33||||||Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.|
1601342|NCT02792699|2941603|Other||LS Mean Difference|0.11|||||2-Sided|90.0|-0.171|0.392|||||||
1601343|NCT02792699|2941603|Other||LS Mean Difference|-0.07|||||2-Sided|90.0|-0.353|0.213|||||||
1601344|NCT02792699|2941603|Equivalence|Clinical equivalence was tested by comparing the 2-sided 90% CI of the change from baseline at week 24 of DAS28-CRP between ABP 798 and rituximab with an equivalence margin of (-0.6, 0.6).|LS Mean Difference|0.02|||||2-Sided|90.0|-0.225|0.264||||||If PK similarity was established between rituximab (US) and rituximab (EU), the 2 rituximab arms were to be combined into a single reference group for the primary assessment of clinical equivalence of DAS28-CRP change from baseline at week 24 using a repeated measures analysis with DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and baseline DAS28-CRP as predictors, and unstructured covariance matrix in the model.|
1601407|NCT02790788|2941739|Superiority||Mean Difference (Net)|0.048|Standard Error of the Mean|0.145||0.74|2-Sided|95.0|-0.243|0.339|||t-test, 2 sided|||RESULTS CORRESPOND TO ΤΝFα AT 72 HOURS AFTER ROSC|
1601408|NCT02790788|2941739|Superiority||Mean Difference (Net)|0.03|Standard Error of the Mean|0.161||0.85|2-Sided|95.0|-0.294|0.354|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 72 HOURS AFTER ROSC|
1601345|NCT02792699|2941612|Equivalence|PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9531|||||2-Sided|90.0|0.907|1.0015||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601346|NCT02792699|2941612|Equivalence|PK similarity between the test (ABP 798) and reference (rituximab [EU]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9475|||||2-Sided|90.0|0.9021|0.9953||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601347|NCT02792699|2941612|Equivalence|PK similarity between the test (ABP 798) and reference (rituximab [US]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9942|||||2-Sided|90.0|0.9461|1.0448||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601348|NCT02792699|2941612|Other||LS Geometric Mean|320.87|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601349|NCT02792699|2941612|Other||LS Geometric Mean|305.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601350|NCT02792699|2941612|Other||Geometric LS Mean|304.04|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601351|NCT02792699|2941613|Equivalence|PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9339|||||2-Sided|90.0|0.8707|1.0016||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601352|NCT02792699|2941613|Equivalence|PK similarity between the test (ABP 798) and reference (rituximab [EU]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.8968|||||2-Sided|90.0|0.8363|0.9616||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601353|NCT02792699|2941613|Equivalence|PK similarity between the test (ABP 798) and reference (rituximab [US]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9603|||||2-Sided|90.0|0.895|1.0303||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601354|NCT02792699|2941613|Other||LS Geometric Mean|166811.0|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601355|NCT02792699|2941613|Other||LS Geometric Mean|155778.7|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601356|NCT02792699|2941613|Other||Geometric LS Mean|149590.5|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601357|NCT02792699|2941614|Equivalence|PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9656|||||2-Sided|90.0|0.9104|1.024||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601358|NCT02792699|2941614|Equivalence|PK similarity between the test (ABP 798) and reference (rituximab [EU]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9394|||||2-Sided|90.0|0.8863|0.9958||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601359|NCT02792699|2941614|Equivalence|PK similarity between the test (ABP 798) and reference (rituximab [US]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9729|||||2-Sided|90.0|0.9174|1.0318||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601360|NCT02792699|2941614|Other||LS Geometric Mean|44925.3|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601361|NCT02792699|2941614|Other||LS Geometric Mean|43378.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601362|NCT02792699|2941614|Other||Geometric LS Mean|42203.8|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601363|NCT02792699|2941615|Equivalence|PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9521|||||2-Sided|90.0|0.9055|1.001||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601364|NCT02792699|2941615|Equivalence|PK similarity between the test (ABP 798) and reference (rituximab [EU]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9368|||||2-Sided|90.0|0.8912|0.9848||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601365|NCT02792699|2941615|Equivalence|PK similarity between the test (ABP 798) and reference (rituximab [US]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.984|||||2-Sided|90.0|0.9356|1.0348||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601366|NCT02792699|2941615|Other||LS Geometric Mean|393.29|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601367|NCT02792699|2941615|Other||LS Geometric Mean|374.44|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601368|NCT02792699|2941615|Other||Geometric LS Mean|368.43|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601369|NCT02792699|2941616|Equivalence|PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9246|||||2-Sided|90.0|0.8575|0.997||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601370|NCT02792699|2941616|Equivalence|PK similarity between the test (ABP 798) and reference (rituximab [EU]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.8848|||||2-Sided|90.0|0.8204|0.9542||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601371|NCT02792699|2941616|Equivalence|PK similarity between the test (ABP 798) and reference (rituximab [US]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.|Geometric Mean Ratio|0.9569|||||2-Sided|90.0|0.887|1.0323||||||The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.|
1601372|NCT02792699|2941616|Other||LS Geometric Mean|172213.2|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601373|NCT02792699|2941616|Other||LS Geometric Mean|159236.0|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601374|NCT02792699|2941616|Other||Geometric LS Mean|152371.4|||||||||||||Estimated using an analysis of covariance model adjusted for weight and geographic region.||
1601375|NCT02792517|2941622|Other||Least Squares Geometric Mean Ratio|1.02|||||2-Sided|90.0|0.94|1.12|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.|
1601376|NCT02792517|2941623|Other||Least Squares Geometric Mean Ratio|1.05|||||2-Sided|90.0|0.9|1.23|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.|
1601377|NCT02792517|2941624|Other||Least Squares Geometric Mean Ratio|1.03|||||2-Sided|90.0|0.96|1.1|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.|
1601378|NCT02792517|2941625|Other||Least Squares Geometric Mean Ratio|1.06|||||2-Sided|90.0|0.97|1.16|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.|
1601379|NCT02792517|2941626|Other||Least Squares Geometric Mean Ratio|1.02|||||2-Sided|90.0|0.91|1.14|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed AUCtau was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.|
1601380|NCT02792517|2941627|Other||Least Squares Geometric Mean Ratio|1.04|||||2-Sided|90.0|0.88|1.22|||||Ratio of EE/norgestimate + erenumab to EE/norgestimate alone|The log-transformed Cmax was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.|
1601381|NCT02792062|2941633|Superiority or Other||Least Square Mean Ratio (%)|52.56|||<|0.001|2-Sided|90.0|40.78|67.74|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast − value in fasted condition without breakfast).|
1602241|NCT02756689|2943621|Superiority|||||||0.42|||||||Wilcoxon (Mann-Whitney)||||
1601382|NCT02792062|2941633|Superiority or Other||Least Square Mean Ratio (%)|84.68|||<|0.256|2-Sided|90.0|66.23|108.27|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUClast of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast − value in fasted condition without breakfast).|
1601383|NCT02792062|2941634|Superiority or Other||Least Square Mean Ratio (%)|52.56|||<|0.001|2-Sided|90.0|40.78|67.74|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast − value in fasted condition without breakfast).|
1601384|NCT02792062|2941634|Superiority or Other||Least Square Mean Ratio (%)|84.68|||<|0.256|2-Sided|90.0|66.23|108.27|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC(0-120) of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast − value in fasted condition without breakfast).|
1601385|NCT02792062|2941635|Superiority or Other||Least Square Mean Ratio (%)|53.2|||<|0.001|2-Sided|90.0|41.39|68.37|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast − value in fasted condition without breakfast).|
1601386|NCT02792062|2941635|Superiority or Other||Least Square Mean Ratio (%)|84.28|||<|0.238|2-Sided|90.0|66.09|107.47|||Mixed Models Analysis|||Mixed effect model with natural log-transformed AUC∞ of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast − value in fasted condition without breakfast).|
1601387|NCT02792062|2941636|Superiority or Other||Least Square Mean Ratio (%)|45.43||||0.012|2-Sided|90.0|27.86|74.07|||Mixed Models Analysis|||Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value after breakfast − value in fasted condition without breakfast).|
1601388|NCT02792062|2941636|Superiority or Other||Least Square Mean Ratio (%)|113.06||||0.659|2-Sided|90.0|70.37|181.67|||Mixed Models Analysis|||Mixed effect model with natural log-transformed Cmax of unchanged TAK-385 as dependent variables, arm, treatment period and dosing condition as fixed effects, and participants as a random effect was used to calculate the difference between the dosing conditions (value before breakfast − value in fasted condition without breakfast).|
1601389|NCT02791763|2941705|Superiority||Odds Ratio (OR)|1.01||||0.4941|2-Sided|95.0|0.33|3.04||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment, Baseline Hgb, and Baseline ESA use.||
1601390|NCT02791763|2941706|Superiority||Odds Ratio (OR)|1.01||||0.4941|2-Sided|95.0|0.33|3.04||The p value on this table is one-sided and calculated for the superiority assessment.|Regression, Logistic||Analysis was performed by logistic regression with covariates of treatment, Baseline Hgb, and Baseline ESA use.||
1601391|NCT02791763|2941707|Non-Inferiority|Non-inferiority was to be established as the lower limit of the 95% confidence interval (CI) for the treatment difference was greater than the pre-specified non-inferiority margin (-1.0 g/dL).|Median Difference (Final Values)|0.1|Standard Error of the Mean|0.088|<|0.0001|2-Sided|95.0|-0.07|0.28||The p value on this table is one-sided and calculated for the non-inferiority assessment.|Mixed model repeated measures (MMRM)||Analysis was performed by a MMRM with covariates of treatment, Baseline Hgb, visit, treatment-by-visit interaction and Baseline-by-visit interaction.||
1601392|NCT02791516|2941709|Superiority||LS Mean Difference|2.2|Standard Error of the Mean|0.7||0.004|2-Sided|95.0|0.7|3.6|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.|||
1601393|NCT02791516|2941710|Superiority||LS Mean Difference|2.6|Standard Error of the Mean|0.6|<|0.001|2-Sided|95.0|1.4|3.7|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.|||
1601394|NCT02791516|2941711|Superiority||LS Mean Difference|9.6|Standard Error of the Mean|1.0|<|0.001|2-Sided|95.0|7.6|11.5|||ANCOVA|ANCOVA model adjusting for treatment, baseline DXA BMD value, machine type, and machine type-by-baseline DXA BMD value.|||
1601395|NCT02791490|2941714|Superiority||Difference in Least Squares Means|-12.4||||0.002|2-Sided|95.0|-20.2|-4.6|||Longitudinal Data Analysis||||
1601396|NCT02791490|2941715|Superiority||Relative Risk|1.7||||0.002|2-Sided|95.0|1.2|2.5|||Miettinen and Nurminen method||||
1601397|NCT02791490|2941717|Other|95% CI|Difference in % vs Placebo|-1.7|||||2-Sided|95.0|-10.8|7.4|||||||
1601398|NCT02791490|2941718|Superiority||Difference in Least Squares Means|-0.41|||<|0.001|2-Sided|95.0|-0.59|-0.23|||Longitudinal Data Analysis||||
1601399|NCT02791308|2941730|Equivalence|Proportion of Subjects with Treatment Success at Visit 4/Day 15|Other|0.407|||||2-Sided|90.0|-15.57|3.53||||||Percentage of Subjects with Treatment Success at Visit 4/Day 15|
1601400|NCT02790788|2941737|Superiority||Mann-Whitney U|1128.5||||0.37|2-Sided||||||Mann-Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF INFECTION|
1601401|NCT02790788|2941737|Superiority||Mann Whitney U|52188.5||||0.68|2-Sided||||||Mann-Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF HYPERNATREMIA|
1601402|NCT02790788|2941737|Superiority||Mann-Whitney U|50903.5||||0.68|2-Sided||||||Mann Whitney|||RESULTS CORRESPOND TO THE NUMBER OF EPISODES OF HYPERGLYCEMIA|
1601403|NCT02790788|2941738|Superiority||Percent Difference|4.9||||0.45|2-Sided|95.0|-4.8|14.6|||Fisher Exact||||
1601404|NCT02790788|2941739|Superiority||Mean Difference (Net)|0.179|Standard Error of the Mean|0.147||0.23|2-Sided|95.0|-0.116|0.475|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 72 HOURS AFTER ROSC|
1601405|NCT02790788|2941739|Superiority||Mean Difference (Net)|-0.045|Standard Error of the Mean|0.096||0.64|2-Sided|95.0|-0.238|0.149|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 72 HOURS AFTER ROSC|
1669895|NCT01387815|3072825|Other|||||||0.367|||||||t-test, 2 sided||||
1601409|NCT02790788|2941739|Superiority||Mean Difference (Net)|0.027|Standard Error of the Mean|0.124||0.83|2-Sided|95.0|-0.223|0.276|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 48 HOURS AFTER ROSC|
1601410|NCT02790788|2941739|Superiority||Mean Difference (Net)|-0.024|Standard Error of the Mean|0.111||0.83|2-Sided|95.0|-0.246|0.198|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 48 HOURS AFTER ROSC|
1601411|NCT02790788|2941739|Superiority||Mean Difference (Net)|0.056|Standard Error of the Mean|0.043||0.2|2-Sided|95.0|-0.03|0.142|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 48 HOURS AFTER ROSC|
1601412|NCT02790788|2941739|Superiority||Mean Difference (Net)|0.036|Standard Error of the Mean|0.14||0.8|2-Sided|95.0|-0.246|0.318|||t-test, 2 sided|||RESULTS CORRESPOND TO ΤΝFα AT 48 HOURS AFTER ROSC|
1601413|NCT02790788|2941739|Superiority||Mean Difference (Net)|-0.043|Standard Error of the Mean|0.127||0.74|2-Sided|95.0|-0.298|0.212|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 48 HOURS AFTER ROSC|
1601414|NCT02790788|2941739|Superiority||Mean Difference (Net)|0.147|Standard Error of the Mean|0.162||0.37|2-Sided|95.0|-0.179|0.473|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 24 HOURS AFTER ROSC|
1601415|NCT02790788|2941739|Superiority||Mean Difference (Net)|-0.022|Standard Error of the Mean|0.111||0.85|2-Sided|95.0|-0.244|0.201|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 24 HOURS AFTER ROSC|
1601416|NCT02790788|2941739|Superiority||Mean Difference (Net)|-0.04|Standard Error of the Mean|0.03||0.19|2-Sided|95.0|-0.1|0.021|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 24 HOURS AFTER ROSC|
1601417|NCT02790788|2941739|Superiority||Mean Difference (Net)|0.014|Standard Error of the Mean|0.126||0.91|2-Sided|95.0|-0.238|0.267|||t-test, 2 sided|||RESULTS CORRESPOND TO TNFα AT 24 HOURS AFTER ROSC|
1601418|NCT02790788|2941739|Superiority||Median Difference (Net)|0.067|Standard Error of the Mean|0.129||0.61|2-Sided|95.0|-0.192|0.326|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 24 HOURS AFTER ROSC|
1601419|NCT02790788|2941739|Superiority||Mean Difference (Net)|0.007|Standard Error of the Mean|0.167||0.97|2-Sided|95.0|-0.326|0.34|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-10 AT 4 HOURS AFTER ROSC|
1601420|NCT02790788|2941739|Superiority||Mean Difference (Net)|-0.041|Standard Error of the Mean|0.107||0.7|2-Sided|95.0|-0.254|0.172|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-8 AT 4 HOURS AFTER ROSC|
1601421|NCT02790788|2941739|Superiority||Mean Difference (Net)|0.034|Standard Error of the Mean|0.053||0.52|2-Sided|95.0|-0.071|0.139|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-1β AT 4 HOURS AFTER ROSC|
1601422|NCT02790788|2941739|Superiority||Mean Difference (Net)|-0.064|Standard Error of the Mean|0.111||0.56|2-Sided|95.0|-0.287|0.158|||t-test, 2 sided|||RESULTS CORRESPOND TO TNF-α AT 4 HOURS AFTER ROSC|
1601423|NCT02790788|2941739|Superiority||Mean Difference (Net)|-0.025|Standard Error of the Mean|0.144||0.86|2-Sided|95.0|-0.311|0.262|||t-test, 2 sided|||RESULTS CORRESPOND TO IL-6 AT 4 HOURS AFTER ROSC|
1601424|NCT02790788|2941740|Superiority|||||||0.84|||||||Mann Whitney||||
1601425|NCT02790788|2941741|Superiority||Median Difference (Net)|1.15|Standard Error of the Mean|1.23||0.36|2-Sided|95.0|-1.4|3.7|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 72 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 97.0 MMHG|
1601426|NCT02790788|2941741|Superiority||Mean Difference (Net)|0.9|Standard Error of the Mean|1.15||0.44|2-Sided|95.0|-1.49|3.28|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 72 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 75.5 MMHG|
1601427|NCT02790788|2941741|Superiority||Median Difference (Net)|0.68|Standard Error of the Mean|0.79||0.4|2-Sided|95.0|-0.94|2.3|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 4 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 96.0 MMHG|
1601428|NCT02790788|2941741|Superiority||Mean Difference (Net)|0.71|Standard Error of the Mean|0.87||0.42|2-Sided|95.0|-2.5|1.1|||t-test, 2 sided|||RESULTS CORRESPOND TO CBFI AT 4 HOURS AFTER ROSC AND AT A MEAN MAP LEVEL OF 75.5 MMHG|
1601429|NCT02790788|2941742|Superiority||Median Difference (Net)|-0.16|Standard Error of the Mean|0.26||0.54|2-Sided|95.0|-0.69|0.36|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 42-48 HOURS AFTER ROSC.|
1601430|NCT02790788|2941742|Superiority||Mean Difference (Net)|-0.15|Standard Error of the Mean|0.28||0.6|2-Sided|95.0|-0.71|0.41|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 36-42 HOURS AFTER ROSC.|
1601431|NCT02790788|2941742|Superiority||Mean Difference (Net)|-0.14|Standard Error of the Mean|0.28||0.62|2-Sided|95.0|-0.69|0.42|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 30-36 HOURS AFTER ROSC.|
1601432|NCT02790788|2941742|Superiority||Median Difference (Net)|-0.16|Standard Error of the Mean|0.25||0.54|2-Sided|95.0|-0.66|0.35|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 24-30 HOURS AFTER ROSC.|
1601433|NCT02790788|2941742|Superiority||Mean Difference (Net)|-0.27|Standard Error of the Mean|0.29||0.36|2-Sided|95.0|-0.85|0.31|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 18-24 HOURS AFTER ROSC.|
1601434|NCT02790788|2941742|Superiority||Median Difference (Net)|-0.48|Standard Error of the Mean|0.26||0.07|2-Sided|95.0|-1.0|0.04|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 12-18 HOURS AFTER ROSC.|
1601435|NCT02790788|2941742|Superiority||Mean Difference (Net)|-0.36|Standard Error of the Mean|0.28||0.2|2-Sided|95.0|-0.92|0.19|||t-test, 2 sided|||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 12-18 HOURS AFTER ROSC.|
1601436|NCT02790788|2941742|Superiority||Mean Difference (Net)|0.8|Standard Error of the Mean|1.0||0.41|2-Sided|95.0|-1.2|2.8||RESULTS CORRESPOND TO CORE BODY TEMPERATURE AVERAGED OVER 0-6 HOURS AFTER ROSC.|t-test, 2 sided||||
1601437|NCT02790788|2941743|Superiority||Mean Difference (Net)|0.19|Standard Error of the Mean|0.41||0.65|2-Sided|95.0|-0.64|1.02|||t-test, 2 sided||||
1601438|NCT02790788|2941744|Superiority||Mean Difference (Net)|0.17|Standard Error of the Mean|0.38||0.67|2-Sided|95.0|-0.6|0.93|||t-test, 2 sided||||
1601439|NCT02790788|2941745|Superiority||Mean Difference (Net)|0.2|Standard Error of the Mean|0.37||0.59|2-Sided|95.0|-0.54|0.94|||t-test, 2 sided||||
1601440|NCT02790788|2941746|Superiority||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.65||0.9|2-Sided|95.0|-1.5|1.3|||t-test, 2 sided||||
1601441|NCT02790788|2941747|Superiority||Mean Difference (Net)|-0.11|Standard Error of the Mean|0.11||0.34|2-Sided|95.0|-0.33|0.12|||t-test, 2 sided|||RESULTS CORRESPOND TO END-SYSTOLIC ECCI AT 72 HOURS AFTER ROSC.|
1601596|NCT02784106|2942052|Superiority||Difference in Proportion of Responders|0.06|||||2-Sided|80.0|0.01|0.14||||||Day 28|
1601442|NCT02790788|2941747|Superiority||Mean Difference (Net)|-0.08|Standard Error of the Mean|0.1||0.46|2-Sided|95.0|-0.29|0.14|||t-test, 2 sided|||RESULTS CORRESPOND TO END-DIASTOLIC ECCI AT 72 HOURS AFTER ROSC.|
1601443|NCT02790788|2941747|Superiority||Mean Difference (Net)|-0.08|Standard Error of the Mean|0.09||0.38|2-Sided|95.0|-0.26|0.1|||t-test, 2 sided|||RESULTS CORRESPOND TO END-SYSTOLIC ECCI WITHIN 12 HOURS AFTER ROSC.|
1601444|NCT02790788|2941747|Superiority||Mean Difference (Net)|-0.07|Standard Error of the Mean|0.09||0.41|2-Sided|95.0|-0.25|0.11|||t-test, 2 sided|||RESULTS CORRESPOND TO END-DIASTOLIC ECCI WITHIN 12 HOURS OF ROSC.|
1601445|NCT02790788|2941748|Superiority||Mean Difference (Net)|-1.8|Standard Error of the Mean|3.5||0.61|2-Sided|95.0|-9.1|5.5|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEF WITHIN 72 HOURS AFTER ROSC|
1601446|NCT02790788|2941748|Superiority||Mean Difference (Net)|-4.9|Standard Error of the Mean|4.2||0.25|2-Sided|95.0|-13.5|3.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEF AT 72 HOURS AFTER ROSC|
1601447|NCT02790788|2941748|Superiority||Mean Difference (Net)|-1.0|Standard Error of the Mean|3.1||0.76|2-Sided|95.0|-7.2|5.3|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEF WITHIN 12 HOURS AFTER ROSC|
1601448|NCT02790788|2941748|Superiority||Mean Difference (Net)|-3.6|Standard Error of the Mean|3.6||0.32|2-Sided|95.0|-10.9|3.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEF WITHIN 12 HOURS AFTER ROSC|
1601449|NCT02790788|2941749|Superiority||Mean Difference (Net)|1.9|Standard Error of the Mean|1.4||0.18|2-Sided|95.0|-1.0|4.7|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEDA AT 72 HOURS AFTER ROSC|
1601450|NCT02790788|2941749|Superiority||Mean Difference (Net)|4.6|Standard Error of the Mean|2.17||0.048|2-Sided|95.0|0.04|9.15|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEDA AT 72 HOURS AFTER ROSC|
1601451|NCT02790788|2941749|Superiority||Mean Difference (Net)|-0.81|Standard Error of the Mean|1.3||0.54|2-Sided|95.0|-3.4|1.8|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO RVEDA WITHIN 12 HOURS AFTER ROSC|
1601452|NCT02790788|2941749|Superiority||Mean Difference (Net)|0.3|Standard Error of the Mean|2.8||0.92|2-Sided|95.0|-5.3|5.8|||t-test, 2 sided|||REPORTED RESULTS CORRESPOND TO LVEDA WITHIN 12 HOURS AFTER ROSC|
1601453|NCT02790788|2941750|Superiority||Mean Difference (Net)|2.1|Standard Error of the Mean|2.2||0.33|2-Sided|95.0|-2.2|6.4|||t-test, 2 sided||||
1601454|NCT02790788|2941751|Superiority||Mean Difference (Net)|0.5|Standard Error of the Mean|3.4||0.9|2-Sided|95.0|-6.4|7.3|||t-test, 2 sided||||
1601455|NCT02790788|2941752|Superiority||Mean Difference (Net)|2.8|Standard Error of the Mean|1.9||0.14|2-Sided|95.0|-0.9|6.6|||t-test, 2 sided||||
1601456|NCT02790788|2941753|Superiority||Mean Difference (Net)|-4.0|Standard Error of the Mean|3.0||0.2|2-Sided|95.0|-10.1|2.1|||t-test, 2 sided||||
1601457|NCT02790788|2941754|Superiority||Mean Difference (Net)|1.0|Standard Error of the Mean|2.0||0.64|2-Sided|95.0|-3.1|5.0|||t-test, 2 sided||||
1601458|NCT02790788|2941755|Superiority||Mean Difference (Net)|-2.0|Standard Error of the Mean|3.7||0.59|2-Sided|95.0|-9.3|5.3|||t-test, 2 sided||||
1601459|NCT02790788|2941756|Superiority||Mean Difference (Final Values)|10.6|Standard Error of the Mean|5.0||0.043|2-Sided|95.0|0.4|20.8|||t-test, 2 sided||||
1601460|NCT02790788|2941757|Superiority||Mean Difference (Net)|5.0|Standard Error of the Mean|3.6||0.17|2-Sided|95.0|-2.2|12.2|||t-test, 2 sided||||
1601461|NCT02790788|2941759|Superiority||Mean Difference (Net)|3.3|Standard Error of the Mean|4.3||0.44|2-Sided|95.0|-5.2|11.8|||t-test, 2 sided|||Independent Samples t-test|
1601462|NCT02790606|2941772|Superiority||||||<|0.0001||||||The p-value is compared to the PG (40%) and computed using the exact binomial test.|Exact binomial test|||"The primary effectiveness endpoint is evaluated against a PG of 40%, which was derived from clinical literature as well as other pivotal and post-market studies of stent grafts at the graft–vein anastomosis of AV access patients dialyzing with an AV graft. 89% estimated power for primary endpoint.~Hypothesis: The proportion of subjects treated with the COVERA™ Vascular Covered Stent (following PTA) with respect to TLPP through 6 months post-index procedure is greater than that of the PG of 40%."|
1601463|NCT02790606|2941773|Superiority|||||||0.0021|||||||Exact binomial test|||"The primary safety endpoint is evaluated against a PG of 88%, which was derived from safety event rates of PTA in published literature.~Hypothesis: The safety rate in subjects treated with the COVERA™ Vascular Covered Stent (following PTA) at 30 days post-index procedure is greater than that of the PG of 88%. 109 treated subjects [104 evaluable] will give 99% power with one-sided type I error = 0.05."|
1601464|NCT02790073|2941779|Other|Within group comparison vs baseline||||||0.003|||||||t-test, 2 sided||||
1601465|NCT02790073|2941780|Other|Within group comparison vs baseline||||||0.015|||||||t-test, 2 sided||||
1601466|NCT02790073|2941781|Other|Within group comparison vs baseline|||||<|0.001|||||||t-test, 2 sided||||
1601467|NCT02789410|2941782|Superiority|||||||0.971|||||||Wilcoxon (Mann-Whitney)||||
1601468|NCT02789410|2941783|Superiority|||||||0.59|||||||Wilcoxon (Mann-Whitney)||||
1601469|NCT02789410|2941784|Superiority|||||||0.132|||||||Wilcoxon (Mann-Whitney)||||
1601470|NCT02788474|2941814|Other||Adjusted mean difference|-0.00307|Standard Error of the Mean|0.00262||0.2429|2-Sided|95.0|-0.00823|0.00209||random coefficient regression model (C3M (log10-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.|random coefficient regression||Difference calculated as Nintedanib minus Placebo. Inter−individual variability is modelled by a Variance−Components variance−covariance matrix.|"The rate of change (slope) in blood C3M was assumed to be linear in each subject over the 12 weeks of treatment.~Within−patient errors are modelled by an Unstructured variance−covariance matrix."|
1601471|NCT02788474|2941815|Other||Adjusted mean difference|0.00121|Standard Error of the Mean|0.002||0.5469|2-Sided|95.0|-0.00273|0.00515||random coefficient regression model (C1M (negative reciprocal root-transformed)) with fixed effects for gender, age, height and random effect of patient specific intercept and time.|random coefficient regression||Difference calculated as Nintedanib minus Placebo. Inter−individual variability is modelled by a Variance−Components variance−covariance matrix.|"The rate of change (slope) in blood C1M was assumed to be linear in each subject over the 12 weeks of treatment.~Within−patient errors are modelled by an Unstructured variance−covariance matrix."|
1601597|NCT02784106|2942053|Superiority||Difference in Proportion of Responders|-0.01|||||2-Sided|80.0|-0.15|0.12||||||Day 84|
1601472|NCT02788474|2941816|Other||Odds Ratio (OR)|0.772||||0.3175|2-Sided|95.0|0.46|1.27|||Regression, Logistic|||To assess whether the monthly rate of change (slope) in blood CRPM in the first 12 weeks could explain the effect of treatment on disease progression (as defined by absolute forced vital capacity (FVC) decline >=10% or death), a logistic regression analysis including baseline blood CRPM, the rate of change (slope) in blood CRPM in the first 12 weeks and randomised treatment as covariates was applied.|
1601473|NCT02788474|2941816|Other||Odds Ratio (OR)|0.769||||0.3116|2-Sided|95.0|0.46|1.27|||Regression, Logistic|||To assess whether the overall treatment regimen affected disease progression (as defined by absolute forced vital capacity (FVC) decline >=10% or death), a logistic regression analysis including baseline blood CRPM and randomised treatment as covariates was applied.|
1601474|NCT02788474|2941816|Other||slope estimate|-45.566||||0.1537|2-Sided|95.0|-109.55|16.37|||Regression, Logistic||Slope estimate is the monthly rate of change in CRPM up to week 12|To assess how nintedanib treatment affected the association between disease progression (as defined by absolute forced vital capacity (FVC) decline >=10% or death) and the change in CRPM in the first 12 weeks, a logistic regression analysis including baseline blood CRPM, the monthly rate of change (slope) in blood CRPM up to Week 12, treatment and treatment-CRPM slope interaction as covariates was applied.|
1601475|NCT02788474|2941816|Other||slope estimate|22.001||||0.2084|2-Sided|95.0|-11.83|57.58|||Regression, Logistic||Slope estimate is the monthly rate of change in CRPM up to week 12|To assess the association between disease progression (as defined by absolute forced vital capacity (FVC) decline >=10% or death) and the change in the Extracellular matrix (ECM) biomarker CRPM in the first 12 weeks, a logistic regression analysis including baseline blood CRPM and the monthly rate of change (slope) in blood CRPM in the first 12 weeks as covariates was applied for placebo-treated patients only to evaluate the potential of CRPM as a prognostic biomarker.|
1601476|NCT02788474|2941817|Other||Adjusted mean difference|-0.00066|Standard Error of the Mean|0.00282||0.8146|2-Sided|95.0|-0.00621|0.00488||random coefficient regression (random slopes and intercepts) model including sex, age and height as covariates (Due to the low number of measurements per patient, baseline CRPM was included as a response rather than as a covariate in the analysis)|random coefficient regression|The Kenward-Roger approximation was used to estimate denominators degrees of freedom.|Difference calculated as Nintedanib minus Placebo|"The rate of change (slope) in blood CRPM was assumed to be linear in each subject over the 12 weeks of treatment. The intercepts and slopes were assumed to be normally distributed with arbitrary covariance matrix.~Since the distribution of the data was not normal, a log10 transformation was performed before conducting the statistical analyses.~Significance tests were based on least-square means using 2-sided 95% confidence intervals (2-sided α=0.05)."|
1601477|NCT02788279|2941829|Superiority||Difference in Response Rates|0.0||||1|2-Sided|95.0|-4.89|4.89|||Stratified Cochran-Mantel-Haenszel|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|95% CI for difference in response rates was constructed using Hauck-Anderson method.||
1601478|NCT02788279|2941829|Superiority||Difference in Response Rates|0.51||||1|2-Sided|95.0|-3.92|4.94|||Stratified Cochrane-Mantel-Haenszel|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|95% CI for difference in response rates was constructed using Hauck-Anderson method.||
1601479|NCT02788279|2941830|Superiority||Hazard Ratio (HR)|1.39||||0.0467|2-Sided|95.0|1.0|1.91|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.||
1601480|NCT02788279|2941830|Superiority||Hazard Ratio (HR)|1.21||||0.1726|2-Sided|95.0|0.92|1.6|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.||
1601481|NCT02788279|2941830|Superiority||Hazard Ratio (HR)|1.39||||0.0509|2-Sided|95.0|1.0|1.94|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.||
1601482|NCT02788279|2941830|Superiority||Hazard Ratio (HR)|1.25||||0.1208|2-Sided|95.0|0.94|1.65|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.||
1601483|NCT02788279|2941831|Superiority||Hazard Ratio (HR)|1.18||||0.3553|2-Sided|95.0|0.83|1.69|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.||
1601484|NCT02788279|2941831|Superiority||Hazard Ratio (HR)|1.01||||0.9686|2-Sided|95.0|0.74|1.38|||Unstratified Log-Rank||Hazard ratio was estimated using unstratified Cox regression.||
1601485|NCT02788279|2941831|Superiority||Hazard Ratio (HR)|1.19||||0.336|2-Sided|95.0|0.83|1.71|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.||
1601486|NCT02788279|2941831|Superiority||Hazard Ratio (HR)|1.0||||0.9871|2-Sided|95.0|0.73|1.38|||Stratified Log-Rank|Stratification factors included extended RAS mutation status and time since diagnosis of first metastasis.|Hazard ratio was estimated using stratified Cox regression.||
1601487|NCT02787863|2941843|Other||||||<|0.05|||||||McNemar||||
1601488|NCT02787863|2941844|Other||||||<|0.05|||||||McNemar||||
1601489|NCT02787564|2941846|Other|||||||0.029||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)||||
1601490|NCT02787564|2941847|Other|||||||0.006||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)||||
1601491|NCT02787564|2941848|Other|||||||0.443||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)||||
1601492|NCT02787564|2941849|Other|||||||0.026||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)||||
1601493|NCT02787564|2941850|Other|||||||0.038||||||Comparison of difference of fruit and vegetable amount between intervention group and control group.|Wilcoxon (Mann-Whitney)||||
1601494|NCT02787564|2941851|Other||||||<|0.001||||||Comparison of difference of fruit and vegetable variety between intervention group and control group.|Wilcoxon (Mann-Whitney)||||
1601598|NCT02784106|2942053|Superiority||Difference in Proportion of Responders|-0.04|||||2-Sided|80.0|-0.18|0.09||||||Day 56|
1601599|NCT02784106|2942053|Superiority||Difference in Proportion of Responders|-0.04|||||2-Sided|80.0|-0.13|0.06||||||Day 28|
1601495|NCT02787551|2941859|Superiority||LS Mean Difference|-0.99|Standard Error of the Mean|0.244|<|0.0001|2-Sided|95.0|-1.468|-0.508||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -2 HbA1c (<8.0%, >=8.0%), randomization strata of GLP-1 receptor agonist subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|
1601496|NCT02787551|2941861|Superiority||LS Mean Difference|-2.85|Standard Error of the Mean|0.29|<|0.0001|2-Sided|95.0|-3.42|-2.279||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -2 HbA1c (<8.0%, >=8.0%), randomization strata of GLP-1 RA subtype (once/twice daily formulations, once weekly formulations) at screening, and world region as fixed effects and baseline 2-hour PPG value as a covariate. Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|
1601497|NCT02787551|2941863|Superiority||LS Mean Difference|-1.02|Standard Error of the Mean|0.157|<|0.0001|2-Sided|95.0|-1.325|-0.708||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (<8.0%, >=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and baseline average SMPG value-by-visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).|
1601498|NCT02787551|2941865|Superiority||LS Mean Difference|-1.67|Standard Error of the Mean|0.168|<|0.0001|2-Sided|95.0|-2.001|-1.341||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM with treatment groups, randomization strata of Week -2 HbA1c (<8.0%, >=8.0%), randomization strata of GLP-1 RA subtype at screening, scheduled visit, treatment-by-visit interaction, and world region as fixed effects, and and baseline FPG value-by visit interaction as a covariate. Testing according to the hierarchical testing procedure (continued only if previous outcome measures were statistically significant).|
1601499|NCT02787551|2941867|Superiority||Difference in percentage|36.05|||<|0.0001|2-Sided|95.0|28.11|43.99||Threshold for significance <=0.05|Cochran-Mantel-Haenszel|||HbA1c <7.0%: Insulin Glargine/Lixisenatide FRC vs GLP-1 Receptor Agonist. Analysis was performed using Cochran-Mantel-Haenszel method method stratified on randomization strata of Week -2 HbA1c (<8.0%, >=8.0%), and randomization strata of GLP-1 receptor agonist subtype at screening. Hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially per pre-specified order (only HbA1c < 7% was part of testing).|
1601500|NCT02787551|2941869|Superiority||Least square (LS) mean difference|-0.64|Standard Error of the Mean|0.067|<|0.0001|2-Sided|95.0|-0.77|-0.508||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -2 HbA1c (<8.0%, >=8.0%), GLP-1 RA subtype at screening, visits, treatment-by-visit interaction, world region as fixed effects, baseline HbA1c value-by-visit interaction as a covariate. Analysis included all scheduled measurements obtained during 26-week randomized treatment period, including those obtained after IMP discontinuation/introduction of rescue medication.|
1601501|NCT02786927|2941899|Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1601502|NCT02786927|2941900|Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1601503|NCT02786927|2941901|Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1601504|NCT02785770|2941942|Superiority or Other||LS mean difference|-0.61||||0.3862|2-Sided|90.0|-1.78|0.55|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601505|NCT02785770|2941942|Superiority or Other||LS mean difference|-0.49||||0.4918|2-Sided|90.0|-1.65|0.68|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601506|NCT02785770|2941942|Superiority or Other||LS mean difference|-0.73||||0.3063|2-Sided|90.0|-1.89|0.44|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601507|NCT02785770|2941942|Superiority or Other||LS mean difference|-2.07||||0.0036|2-Sided|90.0|-3.24|-0.91|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601508|NCT02785770|2941942|Superiority or Other||LS mean difference|-0.07||||0.9161|2-Sided|90.0|-1.24|1.09|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601509|NCT02785770|2941942|Superiority or Other||LS mean difference|-0.74||||0.2959|2-Sided|90.0|-1.91|0.43|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601510|NCT02785770|2941942|Superiority or Other||LS mean difference|-1.19||||0.0948|2-Sided|90.0|-2.35|-0.02|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601511|NCT02785770|2941942|Superiority or Other||LS mean difference|-0.68||||0.3391|2-Sided|90.0|-1.85|0.49|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601512|NCT02785770|2941942|Superiority or Other||LS mean difference|0.09||||0.9034|2-Sided|90.0|-1.08|1.25|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601513|NCT02785770|2941942|Superiority or Other||LS mean difference|0.03||||0.9649|2-Sided|90.0|-1.13|1.19|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601514|NCT02785770|2941942|Superiority or Other||LS mean difference|0.2||||0.7759|2-Sided|90.0|-0.96|1.36|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601515|NCT02785770|2941942|Superiority or Other||LS mean difference|-1.18||||0.0947|2-Sided|90.0|-2.34|-0.02|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601516|NCT02785770|2941942|Superiority or Other||LS mean difference|-0.03||||0.97|2-Sided|90.0|-1.19|1.14|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601517|NCT02785770|2941942|Superiority or Other||LS mean difference|1.02||||0.1502|2-Sided|90.0|-0.15|2.18|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601518|NCT02785770|2941942|Superiority or Other||LS mean difference|0.14||||0.8465|2-Sided|90.0|-1.03|1.3|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601519|NCT02785770|2941942|Superiority or Other||LS mean difference|0.8||||0.2588|2-Sided|90.0|-0.36|1.96|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601520|NCT02785770|2941943|Superiority or Other||LS mean difference|-2.07||||0.0734|2-Sided|90.0|-3.97|-0.17|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601521|NCT02785770|2941943|Superiority or Other||LS mean difference|-1.01||||0.3836|2-Sided|90.0|-2.91|0.9|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601522|NCT02785770|2941943|Superiority or Other||LS mean difference|-2.06||||0.0745|2-Sided|90.0|-3.96|-0.16|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601523|NCT02785770|2941943|Superiority or Other||LS mean difference|-1.94||||0.0928|2-Sided|90.0|-3.84|-0.04|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601524|NCT02785770|2941943|Superiority or Other||LS mean difference|-1.51||||0.1924|2-Sided|90.0|-3.41|0.4|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601525|NCT02785770|2941943|Superiority or Other||LS mean difference|-1.88||||0.104|2-Sided|90.0|-3.78|0.02|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601526|NCT02785770|2941943|Superiority or Other||LS mean difference|-2.81||||0.0153|2-Sided|90.0|-4.71|-0.91|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601527|NCT02785770|2941943|Superiority or Other||LS mean difference|-1.72||||0.1366|2-Sided|90.0|-3.62|0.18|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601528|NCT02785770|2941943|Superiority or Other||LS mean difference|0.52||||0.6507|2-Sided|90.0|-1.37|2.41|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601529|NCT02785770|2941943|Superiority or Other||LS mean difference|-0.41||||0.7224|2-Sided|90.0|-2.3|1.48|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601530|NCT02785770|2941943|Superiority or Other||LS mean difference|-2.45||||0.0332|2-Sided|90.0|-4.34|-0.56|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601531|NCT02785770|2941943|Superiority or Other||LS mean difference|-0.57||||0.6192|2-Sided|90.0|-2.46|1.32|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601532|NCT02785770|2941943|Superiority or Other||LS mean difference|-0.99||||0.3889|2-Sided|90.0|-2.88|0.9|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601533|NCT02785770|2941943|Superiority or Other||LS mean difference|-1.17||||0.3085|2-Sided|90.0|-3.06|0.72|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601534|NCT02785770|2941943|Superiority or Other||LS mean difference|-0.94||||0.4126|2-Sided|90.0|-2.83|0.95|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601535|NCT02785770|2941943|Superiority or Other||LS mean difference|-0.64||||0.576|2-Sided|90.0|-2.53|1.25|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601536|NCT02785770|2941944|Superiority or Other||LS mean difference|-2.12||||0.0208|2-Sided|90.0|-3.62|-0.61|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601537|NCT02785770|2941944|Superiority or Other||LS mean difference|-0.36||||0.6976|2-Sided|90.0|-1.86|1.15|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601538|NCT02785770|2941944|Superiority or Other||LS mean difference|1.45||||0.1138|2-Sided|90.0|-0.06|2.95|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601539|NCT02785770|2941944|Superiority or Other||LS mean difference|2.5||||0.0063|2-Sided|90.0|1.0|4.01|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601540|NCT02785770|2941944|Superiority or Other||LS mean difference|2.53||||0.0059|2-Sided|90.0|1.02|4.03|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601541|NCT02785770|2941944|Superiority or Other||LS mean difference|4.09|||<|0.0001|2-Sided|90.0|2.58|5.59|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601542|NCT02785770|2941944|Superiority or Other||LS mean difference|5.83|||<|0.0001|2-Sided|90.0|4.32|7.33|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601543|NCT02785770|2941944|Superiority or Other||LS mean difference|4.46|||<|0.0001|2-Sided|90.0|2.96|5.97|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601544|NCT02785770|2941944|Superiority or Other||LS mean difference|-3.03|||<|0.0009|2-Sided|90.0|-4.53|-1.53|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601545|NCT02785770|2941944|Superiority or Other||LS mean difference|-0.73|||<|0.42|2-Sided|90.0|-2.23|0.76|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601546|NCT02785770|2941944|Superiority or Other||LS mean difference|-0.82|||<|0.368|2-Sided|90.0|-2.32|0.68|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601547|NCT02785770|2941944|Superiority or Other||LS mean difference|0.49|||<|0.5881|2-Sided|90.0|-1.0|1.99|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601548|NCT02785770|2941944|Superiority or Other||LS mean difference|-0.31|||<|0.7344|2-Sided|90.0|-1.81|1.19|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601549|NCT02785770|2941944|Superiority or Other||LS mean difference|0.91|||<|0.3174|2-Sided|90.0|-0.59|2.41|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601550|NCT02785770|2941944|Superiority or Other||LS mean difference|2.38|||<|0.0092|2-Sided|90.0|0.88|3.87|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601551|NCT02785770|2941944|Superiority or Other||LS mean difference|1.28|||<|0.16|2-Sided|90.0|-0.22|2.78|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601552|NCT02785770|2941945|Superiority or Other||LS mean difference|-2.78||||0.0294|2-Sided|90.0|-4.88|-0.68|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601553|NCT02785770|2941945|Superiority or Other||LS mean difference|-1.34||||0.2892|2-Sided|90.0|-3.43|0.74|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601554|NCT02785770|2941946|Superiority or Other||LS mean difference|-2.61||||0.0412|2-Sided|90.0|-4.71|-0.51|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601555|NCT02785770|2941946|Superiority or Other||LS mean difference|-2.16||||0.0893|2-Sided|90.0|-4.24|-0.07|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601556|NCT02785770|2941947|Superiority or Other||LS mean difference|-0.11||||0.9334|2-Sided|90.0|-2.21|1.99|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601557|NCT02785770|2941947|Superiority or Other||LS mean difference|-1.35||||0.287|2-Sided|90.0|-3.44|0.74|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601558|NCT02785770|2941948|Superiority or Other||LS mean difference|1.21||||0.3424|2-Sided|90.0|-0.89|3.31|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601559|NCT02785770|2941948|Superiority or Other||LS mean difference|-1.97||||0.1201|2-Sided|90.0|-4.06|0.12|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601560|NCT02785770|2941949|Superiority or Other||LS mean difference|2.26||||0.0768|2-Sided|90.0|0.16|4.36|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601561|NCT02785770|2941949|Superiority or Other||LS mean difference|-0.48||||0.7024|2-Sided|90.0|-2.57|1.6|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601562|NCT02785770|2941950|Superiority or Other||LS mean difference|4.26||||0.0009|2-Sided|90.0|2.16|6.36|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601563|NCT02785770|2941950|Superiority or Other||LS mean difference|1.24||||0.3272|2-Sided|90.0|-0.84|3.33|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601564|NCT02785770|2941951|Superiority or Other||LS mean difference|5.04|||<|0.0001|2-Sided|90.0|2.95|7.14|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601565|NCT02785770|2941951|Superiority or Other||LS mean difference|0.14|||<|0.9146|2-Sided|90.0|-1.95|2.22|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601566|NCT02785770|2941952|Superiority or Other||LS Mean Difference|4.54||||0.0004|2-Sided|90.0|2.44|6.64|||Repeated Measures Model|||PF-04447943 100 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601567|NCT02785770|2941952|Superiority or Other||Least Square (LS) Mean Difference|-0.29||||0.8195|2-Sided|90.0|-2.38|1.8|||Repeated Measures Model|||PF-04447943 25 mg versus Placebo: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601568|NCT02785770|2941953|Superiority or Other||LS mean difference|3.74||||0.0036|2-Sided|90.0|1.64|5.85|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 24 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601569|NCT02785770|2941953|Superiority or Other||LS mean difference|5.53|||<|0.0001|2-Sided|90.0|3.42|7.64|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 12 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601570|NCT02785770|2941953|Superiority or Other||LS mean difference|8.07|||<|0.0001|2-Sided|90.0|5.96|10.18|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 8 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601571|NCT02785770|2941953|Superiority or Other||LS mean difference|8.96|||<|0.0001|2-Sided|90.0|6.85|11.07|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 4 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601572|NCT02785770|2941953|Superiority or Other||LS mean difference|8.59|||<|0.0001|2-Sided|90.0|6.48|10.7|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 3 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601600|NCT02784106|2942054|Superiority||Difference in Mean Changes|-1.93|||||2-Sided|80.0|-5.54|1.69|||||||
1601573|NCT02785770|2941953|Superiority or Other||LS mean difference|11.33|||<|0.0001|2-Sided|90.0|9.22|13.44|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 2 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601574|NCT02785770|2941953|Superiority or Other||LS mean difference|7.88|||<|0.0001|2-Sided|90.0|5.77|9.99|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 1 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601575|NCT02785770|2941953|Superiority or Other||LS mean difference|0.96|||<|0.454|2-Sided|90.0|-1.15|3.07|||Repeated Measures Model|||Moxifloxacin 400 mg versus Placebo, 0.5 Hour: P-value was derived from repeated measures model with sequence, period, time, treatment and time-by-treatment as fixed effects and participant within sequence as a random effect.|
1601576|NCT02785354|2941999|Superiority or Other||Hazard Ratio (HR)|0.84|||<|0.0001|2-Sided|95.0|0.79|0.89|||Cox proportional hazard risk model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.|
1601577|NCT02785354|2941999|Superiority or Other||Hazard Ratio (HR)|0.71|||<|0.0001|2-Sided|95.0|0.66|0.76|||Cox proportional hazard risk model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.|
1601578|NCT02785354|2942000|Superiority or Other||Hazard Ratio (HR)|0.77|||<|0.0001|2-Sided|95.0|0.71|0.84|||Cox proportional hazard risk model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI.|
1601579|NCT02785354|2942000|Superiority or Other||Hazard Ratio (HR)|0.74|||<|0.0001|2-Sided|95.0|0.67|0.82|||Cox proportional hazard risk model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Kaplan-Meier to estimate the cumulative incidence, 2) Cox proportional hazard risk model to compare the 1-year risk for dabigatran versus VKA, with HR and 95%CI.|
1601580|NCT02785354|2942001|Superiority or Other||Hazard Ratio (HR)|0.84||||0.0501|2-Sided|95.0|0.71|1.0|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).|
1601581|NCT02785354|2942001|Superiority or Other||Hazard Ratio (HR)|0.79||||0.0147|2-Sided|95.0|0.65|0.95|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).|
1601582|NCT02785354|2942002|Superiority or Other||Hazard Ratio (HR)|0.98||||0.8341|2-Sided|95.0|0.85|1.14|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).|
1601583|NCT02785354|2942002|Superiority or Other||Hazard Ratio (HR)|0.75||||0.0007|2-Sided|95.0|0.63|0.88|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).|
1601584|NCT02785354|2942003|Superiority or Other||Hazard Ratio (HR)|0.68|||<|0.0001|2-Sided|95.0|0.58|0.79|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).|
1601585|NCT02785354|2942003|Superiority or Other||Hazard Ratio (HR)|0.55|||<|0.0001|2-Sided|95.0|0.46|0.66|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95%CI (and death as a competing risk).|
1601586|NCT02785354|2942004|Superiority or Other||Hazard Ratio (HR)|0.83||||0.0006|2-Sided|95.0|0.75|0.92|||Fine and Gray model|||Outcome was analyzed during rivaroxaban or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for rivaroxaban versus VKA, with HR and 95%CI (and death as a competing risk).|
1601587|NCT02785354|2942004|Superiority or Other||Hazard Ratio (HR)|0.58|||<|0.0001|2-Sided|95.0|0.51|0.66|||Fine and Gray model|||Outcome was analyzed during dabigatran or VKA exposure period (on treatment) using: 1) Cumulative function to estimate the incidence (with death as a competing risk), 2) Fine and Gray model to compare the 1-year risk for dabigatran versus VKA, with hazard ratio (HR) and 95% Confidence Interval (CI ) (and death as a competing risk).|
1601588|NCT02784613|2942012|Superiority|||||||0.05||||||Differences in pre- and post-treatment scores were compared using Wilcoxon signed-rank test for non-parametric matched pairs. All tests of significance were 2-tailed. All analyses were performed in Stata®, version 13.|t-test, 2 sided||||
1601589|NCT02784106|2942048|Superiority||Difference in Proportion of Participants|-0.04|||||2-Sided|80.0|-0.13|0.06|||||||
1601590|NCT02784106|2942049|Superiority||Difference in Proportion of Participants|0.08|||||2-Sided|80.0|-0.04|0.21|||||||
1601591|NCT02784106|2942050|Superiority||Difference in Mean Changes|0.07|||||2-Sided|80.0|-0.29|0.43||||||Day 84|
1601592|NCT02784106|2942050|Superiority||Difference in Mean Changes|-0.08|||||2-Sided|80.0|-0.33|0.16||||||Day 28|
1601593|NCT02784106|2942051|Superiority||Difference in Mean Changes|-1.4|||||2-Sided|80.0|-5.37|2.58|||||||
1601594|NCT02784106|2942052|Superiority||Difference in Proportion of Responders|-0.04|||||2-Sided|80.0|-0.15|0.07||||||Day 84|
1601595|NCT02784106|2942052|Superiority||Difference in Proportion of Responders|0.03|||||2-Sided|80.0|-0.05|0.11||||||Day 56|
1601602|NCT02783729|2942065|Superiority||LSM Difference|0.59|Standard Error of the Mean|0.372|=|0|2-Sided|95.0|-0.14|1.32||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Zolpidem ER, Lemborexant 10 mg|
1601603|NCT02783729|2942065|Superiority||LSM Difference|1.39|Standard Error of the Mean|0.37|=|0|2-Sided|95.0|0.66|2.11||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Zolpidem ER, Lemborexant 5 mg|
1601604|NCT02783729|2942065|Superiority||LSM Difference|-0.45|Standard Error of the Mean|0.394|=|0|2-Sided|95.0|-1.22|0.33||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Placebo, Lemborexant 10 mg|
1601605|NCT02783729|2942065|Superiority||LSM Difference|0.35|Standard Error of the Mean|0.393|=|0|2-Sided|95.0|-0.42|1.12||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline COA as a covariate.|MMRM|||COA: Placebo, Lemborexant 5 mg|
1601606|NCT02783729|2942065|Superiority||LSM Difference|6.92|Standard Error of the Mean|3.913|=|0|2-Sided|95.0|-0.76|14.6||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Zolpidem ER, Lemborexant 10 mg|
1601607|NCT02783729|2942065|Superiority||LSM Difference|12.73|Standard Error of the Mean|3.894|=|0|2-Sided|95.0|5.09|20.38||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Zolpidem ER, Lemborexant 5 mg|
1601608|NCT02783729|2942065|Superiority||LSM Difference|-5.85|Standard Error of the Mean|4.154|=|0|2-Sided|95.0|-14.0|2.3||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Placebo, Lemborexant 10 mg|
1601609|NCT02783729|2942065|Superiority||LSM Difference|-0.03|Standard Error of the Mean|4.141|=|0|2-Sided|95.0|-8.16|8.09||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline QOM as a covariate.|MMRM|||QOM: Placebo, Lemborexant 5 mg|
1601610|NCT02783729|2942066|Superiority||LSM Difference|-181.33|Standard Error of the Mean|57.255|=|0|2-Sided|95.0|-293.71|-68.96||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Zolpidem ER, Lemborexant 10 mg|
1601611|NCT02783729|2942066|Superiority||LSM Difference|-203.36|Standard Error of the Mean|57.171|=|0|2-Sided|95.0|-315.56|-91.15||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Zolpidem ER, Lemborexant 5 mg|
1601612|NCT02783729|2942066|Superiority||LSM Difference|50.83|Standard Error of the Mean|60.702|=|0|2-Sided|95.0|-68.3|169.97||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Placebo, Lemborexant 10 mg|
1601613|NCT02783729|2942066|Superiority||LSM Difference|28.81|Standard Error of the Mean|60.626|=|0|2-Sided|95.0|-90.18|147.8||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline SOMT as a covariate.|MMRM|||SOMT: Placebo, Lemborexant 5 mg|
1601614|NCT02783729|2942066|Superiority||LSM Difference|-10.32|Standard Error of the Mean|11.813|=|0|2-Sided|95.0|-33.5|12.86||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Zolpidem ER, Lemborexant 10 mg|
1601615|NCT02783729|2942066|Superiority||LSM Difference|-19.22|Standard Error of the Mean|11.779|=|0|2-Sided|95.0|-42.34|3.9||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Zolpidem ER, Lemborexant 5 mg|
1601616|NCT02783729|2942066|Superiority||Slope|39.67|Standard Error of the Mean|12.542|=|0|2-Sided|95.0|15.05|64.29||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Placebo, Lemborexant 10 mg|
1601617|NCT02783729|2942066|Superiority||LSM Difference|30.77|Standard Error of the Mean|12.505|=|0|2-Sided|95.0|6.23|55.31||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effects, and the baseline POA as a covariate.|MMRM|||POA: Placebo, Lemborexant 5 mg|
1601618|NCT02783729|2942067|Superiority||LSM Difference|-0.27|Standard Error of the Mean|1.009|=|0|2-Sided|95.0|-2.26|1.71||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 10 mg|
1601619|NCT02783729|2942067|Superiority||LSM Difference|-0.37|Standard Error of the Mean|1.005|=|0|2-Sided|95.0|-2.35|1.6||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 5 mg|
1601620|NCT02783729|2942067|Superiority||LSM Difference|-1.17|Standard Error of the Mean|1.067|=|0|2-Sided|95.0|-3.26|0.93||Based on ANCOVA model with factors of age group, region, treatment and the baseline FSS as a covariate.|ANCOVA|||Placebo, Lemborexant 10 mg|
1601621|NCT02783729|2942067|Superiority||LSM Difference|-1.26|Standard Error of the Mean|1.063|=|0|2-Sided|95.0|-3.35|0.82||Based on ANCOVA model with factors of age group, region, treatment and the baseline FSS as a covariate.|ANCOVA|||Placebo, Lemborexant 5 mg|
1601622|NCT02783729|2942068|Superiority||LSM Difference|0.33|Standard Error of the Mean|0.303|=|0|2-Sided|95.0|-0.26|0.92||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 10 mg|
1601623|NCT02783729|2942068|Superiority||LSM Difference|0.32|Standard Error of the Mean|0.301|=|0|2-Sided|95.0|-0.28|0.91||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Zolpidem ER, Lemborexant 5 mg|
1601750|NCT02783573|2942108|Superiority||LS Mean Difference (Final Values)|-3.18|Standard Error of the Mean|1.86||0.092|2-Sided|95.0|-6.876|0.525|||Mixed Models Analysis||||
1601624|NCT02783729|2942068|Superiority||LSM Difference|-1.08|Standard Error of the Mean|0.32|=|0|2-Sided|95.0|-1.71|-0.46||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Placebo, Lemborexant 10 mg|
1601625|NCT02783729|2942068|Superiority||LSM Difference|-1.1|Standard Error of the Mean|0.319|=|0|2-Sided|95.0|-1.73|-0.47||Based on ANCOVA model with factors of age group, region, treatment and the baseline ISI as a covariate.|ANCOVA|||Placebo, Lemborexant 5 mg|
1601626|NCT02783729|2942069|Superiority||LSM Difference|-0.16|||=|0|2-Sided|95.0|-7.31|6.99||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 10 mg|
1601627|NCT02783729|2942069|Superiority||LSM Difference|0.05|||=|0|2-Sided|95.0|-7.14|7.24||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 5 mg|
1601628|NCT02783729|2942069|Superiority||LSM Difference|7.69|||=|0|2-Sided|95.0|0.68|14.71||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Placebo, Lemborexant 10 mg|
1601629|NCT02783729|2942069|Superiority||LSM Difference|7.91|||=|0|2-Sided|95.0|0.86|14.96||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, Last 7 nights: Placebo, Lemborexant 5 mg|
1601630|NCT02783729|2942069|Superiority||LSM Difference|3.72|||=|0|2-Sided|95.0|-2.88|10.32||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO: First 7 nights: Zolpidem ER, Lemborexant 10 mg|
1601631|NCT02783729|2942069|Superiority||LSM Difference|0.21|||=|0|2-Sided|95.0|-6.17|6.58||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 5 mg|
1601632|NCT02783729|2942069|Superiority||LSM Difference|10.84|||=|0|2-Sided|95.0|4.57|17.11||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Placebo, Lemborexant 10 mg|
1601633|NCT02783729|2942069|Superiority||LSM Difference|7.3|||=|0|2-Sided|95.0|1.27|13.33||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sWASO, First 7 nights: Placebo, Lemborexant 5|
1601634|NCT02783729|2942069|Superiority||LSM Difference|11.43|||=|0|2-Sided|95.0|3.38|19.48||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Zolpidem ER, Lemborexant 10 mg|
1601635|NCT02783729|2942069|Superiority||LSM Difference|9.59|||=|0|2-Sided|95.0|1.36|17.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Zolpidem ER, Lemborexant 5 mg|
1601636|NCT02783729|2942069|Superiority||LSM Difference|24.13|||<|0.0001|2-Sided|95.0|16.16|32.1||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Placebo, Lemborexant 10 mg|
1601637|NCT02783729|2942069|Superiority||LSM Difference|22.2|||<|0.0001|2-Sided|95.0|14.06|30.35||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 29/30: Placebo, Lemborexant 5 mg|
1601638|NCT02783729|2942069|Superiority||LSM Difference|18.25|||<|0.0001|2-Sided|95.0|10.1|26.4||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO: Days 1/2: Zolpidem ER, Lemborexant 10 mg|
1601639|NCT02783729|2942069|Superiority||LSM Difference|4.89|||=|0|2-Sided|95.0|-3.49|13.28||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Zolpidem ER, Lemborexant 5 mg|
1601640|NCT02783729|2942069|Superiority||LSM Difference|47.57|||<|0.0001|2-Sided|95.0|40.02|55.13||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Placebo, Lemborexant 10 mg|
1601641|NCT02783729|2942069|Superiority||LSM Difference|34.26|||<|0.0001|2-Sided|95.0|26.46|42.06||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||WASO, Days 1/2: Placebo, Lemborexant 5 mg|
1601642|NCT02783729|2942069|Superiority||LSM Difference|5.76|||=|0|2-Sided|95.0|0.34|11.18||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7nights: Zolpidem ER, Lemborexant 10 mg|
1601643|NCT02783729|2942069|Superiority||LSM Difference|8.16|||=|0|2-Sided|95.0|2.51|13.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 5 mg|
1601644|NCT02783729|2942069|Superiority||LSM Difference|7.29|||=|0|2-Sided|95.0|1.8|12.79||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Placebo, Lemborexant 10 mg|
1601645|NCT02783729|2942069|Superiority||LSM Difference|9.69|||=|0|2-Sided|95.0|3.98|15.4||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, Last 7 nights: Placebo, Lemborexant 5 mg|
1601646|NCT02783729|2942069|Superiority||LSM Difference|2.82|||=|0|2-Sided|95.0|-2.02|7.66||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Zolpidem, Lemborexant 10 mg|
1601647|NCT02783729|2942069|Superiority||LSM Difference|2.22|||=|0|2-Sided|95.0|-2.56|7.01||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Zolpidem, Lemborexant 5 mg|
1601648|NCT02783729|2942069|Superiority||LSM Difference|7.5|||=|0|2-Sided|95.0|3.19|11.81||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Placebo, Lemborexant 10 mg|
1601649|NCT02783729|2942069|Superiority||LSM Difference|6.9|||=|0|2-Sided|95.0|2.66|11.14||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||sSOL, First 7 nights: Placebo, Lemborexant 5 mg|
1601650|NCT02783729|2942069|Superiority||LSM Difference|10.89|||=|0|2-Sided|95.0|4.61|17.17||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Zolpidem ER, Lemborexant 10 mg|
1601651|NCT02783729|2942069|Superiority||LSM Difference|8.85|||=|0|2-Sided|95.0|2.68|15.02||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Zolpidem ER, Lemborexant 5 mg|
1601652|NCT02783729|2942069|Superiority||LSM Difference|6.47|||=|0|2-Sided|95.0|-0.55|13.49||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Placebo, Lemborexant 10 mg|
1669896|NCT01387815|3072826|Other|||||||0.609|||||||t-test, 2 sided||||
1601653|NCT02783729|2942069|Superiority||LSM Difference|4.42|||=|0|2-Sided|95.0|-2.5|11.34||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 29/30: Placebo, Lemborexant 5 mg|
1601654|NCT02783729|2942069|Superiority||LSM Difference|7.57|||=|0|2-Sided|95.0|1.71|13.44||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Zolpidem ER, Lemborexant 10 mg|
1601655|NCT02783729|2942069|Superiority||LSM Difference|5.58|||=|0|2-Sided|95.0|-0.14|11.31|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel test stratified by age group.||LPS, Days 1/2: Zolpidem ER, Lemborexant 5 mg|
1601656|NCT02783729|2942069|Superiority||LSM Difference|2.49|||=|0|2-Sided|95.0|-4.2|9.18||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Placebo, Lemborexant 10 mg|
1601657|NCT02783729|2942069|Superiority||LSM Difference|0.41|||=|0|2-Sided|95.0|-6.22|7.04||Based on Cochran-Mantel-Haenszel test stratified by age group.|Cochran-Mantel-Haenszel|||LPS, Days 1/2: Placebo, Lemborexant 5 mg|
1601658|NCT02783729|2942070|Superiority||LSM Difference|7.18|Standard Error of the Mean|1.319|<|0.0001|2-Sided|95.0|4.6|9.77||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Placebo, Lemborexant 10 mg|
1601659|NCT02783729|2942070|Superiority||LSM Difference|4.61|Standard Error of the Mean|1.319|=|0|2-Sided|95.0|2.02|7.19||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Placebo, Lemborexant 5 mg|
1601660|NCT02783729|2942070|Superiority||LSM Difference|6.84|Standard Error of the Mean|1.12|<|0.0001|2-Sided|95.0|4.64|9.04||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Placebo, Lemborexant 10 mg|
1601661|NCT02783729|2942070|Superiority||LSM Difference|3.76|Standard Error of the Mean|1.122|=|0|2-Sided|95.0|1.56|5.97||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Placebo, Lemborexant 5 mg|
1601662|NCT02783729|2942071|Superiority||LSM Difference|37.82|Standard Error of the Mean|6.565|<|0.0001|2-Sided|95.0|24.94|50.71||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Placebo, Lemborexant 10 mg|
1601663|NCT02783729|2942071|Superiority||LSM Difference|23.57|Standard Error of the Mean|6.565|=|0|2-Sided|95.0|10.68|36.45||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Placebo, Lemborexant 5 mg|
1601664|NCT02783729|2942071|Superiority||LSM Difference|34.51|Standard Error of the Mean|5.609|<|0.0001|2-Sided|95.0|23.5|45.52||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Placebo, Lemborexant 10 mg|
1601665|NCT02783729|2942071|Superiority||LSM Difference|19.05|Standard Error of the Mean|5.619|=|0|2-Sided|95.0|8.03|30.08||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Placebo, Lemborexant 5 mg|
1601666|NCT02783729|2942071|Superiority||LSM Difference|-20.57|Standard Error of the Mean|5.574|=|0|2-Sided|95.0|-31.51|-9.63||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Placebo, Lemborexant 10 mg|
1601667|NCT02783729|2942071|Superiority||LSM Difference|-11.49|Standard Error of the Mean|5.573|=|0|2-Sided|95.0|-22.42|-0.55||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Placebo, Lemborexant 5 mg|
1601668|NCT02783729|2942071|Superiority||LSM Difference|-26.34|Standard Error of the Mean|4.762|<|0.0001|2-Sided|95.0|-35.68|-16.99||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Placebo, Lemborexant 10 mg|
1601669|NCT02783729|2942071|Superiority||LSM Difference|-12.41|Standard Error of the Mean|4.764|=|0|2-Sided|95.0|-21.76|-3.06||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Placebo, Lemborexant 5 mg|
1601670|NCT02783729|2942071|Superiority||LSM Difference|0.689|||<|0.0001|2-Sided|95.0|0.618|0.769||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Placebo, Lemborexant 10 mg|
1601671|NCT02783729|2942071|Superiority||LSM Difference|0.75|||<|0.0001|2-Sided|95.0|0.671|0.837||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Placebo, Lemborexant 5 mg|
1601672|NCT02783729|2942071|Superiority||LSM Difference|0.753|||<|0.0001|2-Sided|95.0|0.689|0.823||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Placebo, Lemborexant 10 mg|
1601673|NCT02783729|2942071|Superiority||LSM Difference|0.815|||<|0.0001|2-Sided|95.0|0.745|0.891||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Placebo, Lemborexant 5 mg|
1601674|NCT02783729|2942072|Superiority||LSM Difference|38.85|Standard Error of the Mean|3.672|<|0.0001|2-Sided|95.0|31.64|46.05||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 10 mg|
1669897|NCT01387815|3072827|Other|||||||0.918|||||||t-test, 2 sided||||
1601675|NCT02783729|2942072|Superiority||LSM Difference|34.16|Standard Error of the Mean|3.673|<|0.0001|2-Sided|95.0|26.95|41.36||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 5 mg|
1601676|NCT02783729|2942072|Superiority||LSM Difference|-17.76|Standard Error of the Mean|2.451|<|0.0001|2-Sided|95.0|-22.57|-12.96||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 10 mg|
1601677|NCT02783729|2942072|Superiority||LSM Difference|-16.41|Standard Error of the Mean|2.457|<|0.0001|2-Sided|95.0|-21.23|-11.6||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 5 mg|
1601678|NCT02783729|2942073|Superiority||LSM Difference|11.6|Standard Error of the Mean|0.664|<|0.0001|2-Sided|95.0|10.3|12.9||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM|||SE: Placebo, Lemborexant 10 mg|
1601679|NCT02783729|2942073|Superiority||LSM Difference|9.01|Standard Error of the Mean|0.666|<|0.0001|2-Sided|95.0|7.7|10.31||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline SE as a covariate.|MMRM|||SE: Placebo, Lemborexant 5 mg|
1601680|NCT02783729|2942074|Superiority||LSM Difference|56.9|Standard Error of the Mean|3.284|<|0.0001|2-Sided|95.0|50.46|63.34||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 10 mg|
1601681|NCT02783729|2942074|Superiority||LSM Difference|44.05|Standard Error of the Mean|3.291|<|0.0001|2-Sided|95.0|37.59|50.51||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline TST as a covariate.|MMRM|||TST: Placebo, Lemborexant 5 mg|
1601682|NCT02783729|2942074|Superiority||LSM Difference|-28.33|Standard Error of the Mean|2.219|<|0.0001|2-Sided|95.0|-32.68|-23.98||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 10 mg|
1601683|NCT02783729|2942074|Superiority||LSM Difference|-21.66|Standard Error of the Mean|2.221|<|0.0001|2-Sided|95.0|-26.01|-17.3||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO2H as a covariate.|MMRM|||WASO2H: Placebo, Lemborexant 5 mg|
1601684|NCT02783729|2942074|Superiority||LSM Difference|-42.27|Standard Error of the Mean|2.705|<|0.0001|2-Sided|95.0|-47.57|-36.97||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||WASO: Placebo, Lemborexant 10 mg|
1601685|NCT02783729|2942074|Superiority||LSM Difference|-33.4|Standard Error of the Mean|2.711|<|0.0001|2-Sided|95.0|-38.71|-28.09||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM|||WASO: Placebo, Lemborexant 5 mg|
1601686|NCT02783729|2942074|Superiority||LSM Difference|0.795|||=|0|2-Sided|95.0|0.704|0.899||Based on MMRM model with factors of age group, region, treatment, visit (Days1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS: Placebo, Lemborexant 10 mg|
1601687|NCT02783729|2942074|Superiority||LSM Difference|0.85|||=|0|2-Sided|95.0|0.752|0.961||Based on MMRM model with factors of age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS: Placebo, Lemborexant 5 mg|
1601688|NCT02783729|2942075|Superiority||LSM Difference|1.05|Standard Error of the Mean|1.246|=|0|2-Sided|95.0|-1.4|3.49||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Zolpidem ER, Lemborexant 10 mg|
1601689|NCT02783729|2942075|Superiority||LSM Difference|-1.53|Standard Error of the Mean|1.247|=|0|2-Sided|95.0|-3.98|0.92||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, Last 7 nights: Zolpidem ER, Lemborexant 5 mg|
1601690|NCT02783729|2942075|Superiority|Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate|LSM Difference|1.7|Standard Error of the Mean|1.06|=|0|2-Sided|95.0|-0.38|3.78|||MMRM|||sSE, First 7 nights: Zolpidem ER, Lemborexant 10 mg|
1601691|NCT02783729|2942075|Superiority||LSM Difference|-1.37|Standard Error of the Mean|1.063|=|0|2-Sided|95.0|-3.46|0.71||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSE as a covariate.|MMRM|||sSE, First 7 nights: Zolpidem ER, Lemborexant 5 mg|
1601692|NCT02783729|2942076|Superiority||LSM Difference|7.43|Standard Error of the Mean|6.206|=|0|2-Sided|95.0|-4.75|19.61||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Zolpidem ER, Lemborexant 10 mg|
1601693|NCT02783729|2942076|Superiority||LSM Difference|-6.82|Standard Error of the Mean|6.207|=|0|2-Sided|95.0|-19.01|5.36||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, Last 7 nights: Zolpidem ER, Lemborexant 5 mg|
1601694|NCT02783729|2942076|Superiority||LSM Difference|8.88|Standard Error of the Mean|5.313|=|0|2-Sided|95.0|-1.55|19.31||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sTST as a covariate.|MMRM|||sTST, First 7 nights: Zolpidem ER, Lemborexant 10 mg|
1601695|NCT02783729|2942076|Superiority||LSM Difference|-6.57|Standard Error of the Mean|5.325|=|0|2-Sided|95.0|-17.02|3.88||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baselines sTST as a covariate.|MMRM|||sTST, First 7 nights: Zolpidem ER, Lemborexant 5 mg|
1601696|NCT02783729|2942076|Superiority||LSM Difference|5.36|Standard Error of the Mean|5.241|=|0|2-Sided|95.0|-4.92|15.65||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 10 mg|
1601697|NCT02783729|2942076|Superiority||LSM Difference|14.45|Standard Error of the Mean|5.241|=|0|2-Sided|95.0|4.16|24.73||Based on MMRM model with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, Last 7 nights: Zolpidem ER, Lemborexant 5 mg|
1601698|NCT02783729|2942076|Superiority||LS Mean Difference|-5.81|Standard Error of the Mean|4.481|=|0|2-Sided|95.0|-14.61|2.98||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 10 mg|
1601699|NCT02783729|2942076|Superiority||LSM Difference|8.12|Standard Error of the Mean|4.484|=|0|2-Sided|95.0|-0.68|16.91||Based on MMRM model with factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sWASO as a covariate.|MMRM|||sWASO, First 7 nights: Zolpidem ER, Lemborexant 5 mg|
1601700|NCT02783729|2942076|Superiority||LSM Difference|0.811|||<|0.0001|2-Sided|95.0|0.732|0.899||Based on MMRM model model with log transformation of sSOL and with factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 10 mg|
1601701|NCT02783729|2942076|Superiority||LSM Difference|0.882|||=|0|2-Sided|95.0|0.796|0.978||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (Last 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, Last 7 nights: Zolpidem ER, Lemborexant 5 mg|
1601702|NCT02783729|2942076|Superiority||LSM Difference|0.83|||<|0.0001|2-Sided|95.0|0.763|0.902||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Zolpidem ER, Lemborexant 10 mg|
1601703|NCT02783729|2942076|Superiority||LSM Difference|0.898|||=|0|2-Sided|95.0|0.825|0.977||Based on MMRM model model with log transformation of sSOL and factors of age group, region, treatment, visit (First 7 Nights), and treatment-by-visit interaction as fixed effects, and the baseline sSOL as a covariate.|MMRM|||sSOL, First 7 nights: Zolpidem ER, Lemborexant 5 mg|
1601704|NCT02783729|2942077|Superiority||LSM Difference|24.1|Standard Error of the Mean|3.456|<|0.0001|2-Sided|95.0|17.32|30.88||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 29/30: Zolpidem ER, Lemborexant 10 mg|
1601705|NCT02783729|2942077|Superiority||LSM Difference|19.41|Standard Error of the Mean|3.457|<|0.0001|2-Sided|95.0|12.63|26.2||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 29/30: Zolpidem ER, Lemborexant 5 mg|
1601706|NCT02783729|2942077|Superiority||LSM Difference|23.1|Standard Error of the Mean|3.085|<|0.0001|2-Sided|95.0|17.04|29.15||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 1/2: Zolpidem ER, Lemborexant 10 mg|
1601707|NCT02783729|2942077|Superiority||LSM Difference|10.25|Standard Error of the Mean|3.094|=|0|2-Sided|95.0|4.18|16.32||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline TST as a covariate.|MMRM|||TST, Days 1/2: Zolpidem ER, Lemborexant 5 mg|
1601708|NCT02783729|2942077|Superiority||LSM Difference|-9.1|Standard Error of the Mean|2.883|=|0|2-Sided|95.0|-14.75|-3.45|||MMRM|||WASO, Days 29/30: Zolpidem ER, Lemborexant 10 mg|
1601709|NCT02783729|2942077|Superiority||LSM Difference|-7.72|Standard Error of the Mean|2.876|=|0|2-Sided|95.0|-13.36|-2.08||Based on MMRM model with factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 29/30: Zolpidem ER, Lemborexant 5 mg|
1601710|NCT02783729|2942077|Superiority||LSM Difference|-15.03|Standard Error of the Mean|2.542|<|0.0001|2-Sided|95.0|-20.01|-10.05||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 1/2: Zolpidem ER, Lemborexant 10 mg|
1601711|NCT02783729|2942077|Superiority||LSM Difference|-6.16|Standard Error of the Mean|2.544|=|0|2-Sided|95.0|-11.15|-1.17||Based on MMRM model with factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline WASO as a covariate.|MMRM|||WASO, Days 1/2: Zolpidem ER, Lemborexant 5 mg|
1601712|NCT02783729|2942077|Superiority||LSM Difference|0.594|||<|0.0001|2-Sided|95.0|0.521|0.677||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 29/30: Zolpidem ER, Lemborexant 10 mg|
1601713|NCT02783729|2942077|Superiority||LSM Difference|0.634|||<|0.0001|2-Sided|95.0|0.556|0.724||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 29/30: Zolpidem ER, Lemborexant 5 mg|
1601714|NCT02783729|2942077|Other||LSM Difference|0.818|||=|0|2-Sided|95.0|0.729|0.917||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 1/2: Zolpidem ER, Lemborexant 10 mg|
1601715|NCT02783729|2942077|Superiority||LSM Difference|0.874|||=|0|2-Sided|95.0|0.78|0.981||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 1/2), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM|||LPS, Days 1/2: Zolpidem ER, Lemborexant 5 mg|
1601751|NCT02783573|2942108|Superiority||LS Mean Difference (Final Values)|-2.95|Standard Error of the Mean|1.78||0.1|2-Sided|95.0|-6.488|0.58|||Mixed Models Analysis||||
1669898|NCT01387815|3072828|Other|||||||0.479|||||||t-test, 2 sided||||
1601716|NCT02783729|2942078|Superiority||LSM Difference|-10.74|Standard Error of the Mean|4.04|=|0|2-Sided|95.0|-18.67|-2.81||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effect, and the baseline posture stability of body sway as a covariate.|MMRM|||Zolpidem Tartrate Extended Release 6.25 mg v Lemborexant 10 mg|
1601717|NCT02783729|2942078|Superiority||LSM Difference|-9.63|Standard Error of the Mean|4.029|=|0|2-Sided|95.0|-17.53|-1.72||Based on MMRM model with factors of age group, region, treatment, visit (Days 2/3), and treatment-by-visit interaction as fixed effect, and the baseline posture stability of body sway as a covariate.|MMRM|||Zolpidem Tartrate Extended Release 6.25 mg v Lemborexant 5 mg|
1601718|NCT02783729|2942079|Superiority|Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|LSM Difference|-8.0|Standard Error of the Mean|2.309|=|0|2-Sided|95.0|-12.53|-3.47|||MMRM||||
1601719|NCT02783729|2942079|Superiority|Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO2H as a covariate.|LSM Difference|-6.65|Standard Error of the Mean|2.298|=|0|2-Sided|95.0|-11.15|-2.15|||MMRM||||
1601720|NCT02783729|2942080|Superiority||LSM Difference|-25.35|Standard Error of the Mean|3.067|<|0.0001|2-Sided|95.0|-31.36|-19.34|||MMRM||||
1601721|NCT02783729|2942080|Superiority||LSM Difference|-23.96|Standard Error of the Mean|3.068|<|0.0001|2-Sided|95.0|-29.98|-17.95||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline WASO as a covariate.|MMRM||||
1601722|NCT02783729|2942081|Superiority||LSM Difference|8.03|Standard Error of the Mean|0.746|<|0.0001|2-Sided|95.0|6.57|9.49||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM||||
1601723|NCT02783729|2942081|Superiority||Least Squares Mean (LSM) Difference|7.07|Standard Error of the Mean|0.746|<|0.0001|2-Sided|95.0|5.61|8.54||Based on MMRM model with factors of age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effect, and the baseline SE as a covariate.|MMRM||||
1601724|NCT02783729|2942082|Superiority||LSGM Ratio|0.723|||<|0.0001|2-Sided|95.0|0.628|0.832||Based on MMRM model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM||||
1601725|NCT02783729|2942082|Superiority||Least Squares Geometric Mean(LSGM) Ratio|0.773|||=|0|2-Sided|95.0|0.672|0.889||Based on mixed effect model repeated measurement (MMRM) model with log transformation of LPS and factors for age group, region, treatment, visit (Days 29/30), and treatment-by-visit interaction as fixed effects, and the baseline LPS as a covariate.|MMRM||||
1601726|NCT02783573|2942095|Superiority||LS Mean Difference (Final Values)|-3.08|Standard Error of the Mean|1.06||0.004|2-Sided|95.0|-5.172|-0.991|||ANCOVA||||
1601727|NCT02783573|2942095|Superiority||LS Mean Difference (Final Values)|-1.62|Standard Error of the Mean|1.06||0.127|2-Sided|95.0|-3.708|0.464|||ANCOVA||||
1601728|NCT02783573|2942096|Superiority||LS Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.01||0.93|2-Sided|95.0|-0.015|0.017|||ANCOVA||||
1601729|NCT02783573|2942096|Superiority||LS Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.01||0.927|2-Sided|95.0|-0.015|0.017|||ANCOVA||||
1601730|NCT02783573|2942097|Superiority||LS Mean Difference (Final Values)|-15.2|Standard Error of the Mean|15.43||0.337|2-Sided|95.0|-47.488|17.096|||ANCOVA||||
1601731|NCT02783573|2942097|Superiority||LS Mean Difference (Final Values)|2.22|Standard Error of the Mean|13.76||0.873|2-Sided|95.0|-26.569|31.017|||ANCOVA||||
1601732|NCT02783573|2942098|Superiority||LS Mean Difference (Final Values)|-2.13|Standard Error of the Mean|2.04||0.323|2-Sided|95.0|-6.743|2.481|||ANCOVA||||
1601733|NCT02783573|2942098|Superiority||LS Mean Difference (Final Values)|1.59|Standard Error of the Mean|2.23||0.494|2-Sided|95.0|-3.457|6.64|||ANCOVA||||
1601734|NCT02783573|2942099|Superiority||LS Mean Difference (Final Values)|-13.05|Standard Error of the Mean|13.21||0.349|2-Sided|95.0|-42.929|16.82|||ANCOVA||||
1601735|NCT02783573|2942099|Superiority||LS Mean Difference (Final Values)|16.32|Standard Error of the Mean|14.29||0.283|2-Sided|95.0|-16.015|48.659|||ANCOVA||||
1601736|NCT02783573|2942100|Superiority||LS Mean Difference (Final Values)|-34.15|Standard Error of the Mean|31.27||0.303|2-Sided|95.0|-104.88|36.59|||ANCOVA||||
1601737|NCT02783573|2942100|Superiority||LS Mean Difference (Final Values)|-61.94|Standard Error of the Mean|31.3||0.079|2-Sided|95.0|-132.75|8.87|||ANCOVA||||
1601738|NCT02783573|2942101|Superiority||LS Mean Difference (Final Values)|-40.72|Standard Error of the Mean|35.12||0.276|2-Sided|95.0|-120.17|38.73|||ANCOVA||||
1601739|NCT02783573|2942101|Superiority||LS Mean Difference (Final Values)|-37.55|Standard Error of the Mean|37.49||0.343|2-Sided|95.0|-122.35|47.26|||ANCOVA||||
1601740|NCT02783573|2942102|Superiority||LS Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.86||0.862|2-Sided|95.0|-1.867|1.566|||Mixed Models Analysis||||
1601741|NCT02783573|2942102|Superiority||LS Mean Difference (Final Values)|-1.26|Standard Error of the Mean|0.82||0.126|2-Sided|95.0|-2.891|0.362|||Mixed Models Analysis||||
1601742|NCT02783573|2942103|Superiority||LS Mean Difference (Final Values)|-3.01|Standard Error of the Mean|2.16||0.164|2-Sided|95.0|-7.267|1.238|||Mixed Models Analysis||||
1601743|NCT02783573|2942103|Superiority||LS Mean Difference (Final Values)|0.3|Standard Error of the Mean|2.34||0.899|2-Sided|95.0|-4.297|4.889|||Mixed Models Analysis||||
1601744|NCT02783573|2942105|Superiority||LS Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.6||0.717|2-Sided|95.0|-1.423|0.983|||Mixed Models Analysis||||
1601745|NCT02783573|2942105|Superiority||LS Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.57||0.663|2-Sided|95.0|-0.89|1.391|||Mixed Models Analysis||||
1601746|NCT02783573|2942106|Superiority||LS Mean Difference (Final Values)|-1.97|Standard Error of the Mean|2.82||0.486|2-Sided|95.0|-7.573|3.62|||Mixed Models Analysis||||
1601747|NCT02783573|2942106|Superiority||LS Mean Difference (Final Values)|-4.77|Standard Error of the Mean|2.69||0.079|2-Sided|95.0|-10.103|0.56|||Mixed Models Analysis||||
1601845|NCT02775903|2942513|Superiority|||||||0.618|||||||Wald asymptotic two-sided test||||
1601752|NCT02783573|2942109|Superiority||LS Mean Difference (Final Values)|-0.21|Standard Error of the Mean|1.76||0.903|2-Sided|95.0|-3.725|3.296|||Mixed Models Analysis||||
1601753|NCT02783573|2942109|Superiority||LS Mean Difference (Final Values)|2.51|Standard Error of the Mean|1.64||0.129|2-Sided|95.0|-0.752|5.776|||Mixed Models Analysis||||
1601754|NCT02783027|2942130|Superiority|||||||0.91|||||||t-test, 2 sided|Two sample t-test for change in Occupational Fatigue Exhaustion Recovery (OFER) inter-shift recovery between groups|||
1601755|NCT02783027|2942131|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Test for group*time interaction.|||
1601756|NCT02783027|2942132|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Test for group*time interaction.|||
1601757|NCT02783027|2942133|Superiority||||||<|0.0001||||||Test for group*time interaction.|Mixed Models Analysis||||
1601758|NCT02783027|2942134|Superiority|||||||0.76|||||||t-test, 2 sided|Two sample t-test on the change in sleep quality from baseline to 4 months.|||
1601759|NCT02782169|2942166|Superiority|||||||0.32|||||||t-test, 2 sided||||
1601760|NCT02781818|2942188|Superiority|||||||0.7|||||||Mixed Models Analysis||||
1601761|NCT02781818|2942188|Superiority|||||||0.5|||||||Mixed Models Analysis||||
1601762|NCT02781818|2942189|Superiority|||||||0.98|||||||Mixed Models Analysis||||
1601763|NCT02781818|2942189|Superiority|||||||0.65|||||||Mixed Models Analysis||||
1601764|NCT02781818|2942190|Superiority|||||||0.46|||||||Mixed Models Analysis||||
1601765|NCT02781818|2942190|Superiority|||||||0.77|||||||Mixed Models Analysis||||
1601766|NCT02781454|2942230|Superiority||linear contrast active vs placebo|-2.734||||0.285|2-Sided|95.0|-7.938|2.471|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4|
1601767|NCT02781454|2942231|Superiority||linear contrast active vs placebo|-0.399||||0.601|2-Sided|95.0|-1.966|1.169|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4|
1601768|NCT02781454|2942233|Superiority||linear contrast active vs placebo|0.708||||0.713|2-Sided|95.0|0.111|4.535|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo|
1601769|NCT02781454|2942234|Superiority||linear contrast active vs placebo|-2.017||||0.273|2-Sided|95.0|-5.767|1.733|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4|
1601770|NCT02781454|2942235|Superiority||linear contrast active vs placebo|2.597||||0.323|2-Sided|95.0|-2.772|7.966|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4|
1601771|NCT02781454|2942236|Superiority||linear contrast active vs placebo|0.242||||0.969|2-Sided|95.0|-12.64|13.126|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4|
1601772|NCT02781454|2942237|Superiority||linear contrast active vs placebo|1.089||||0.694|2-Sided|95.0|-4.609|6.786|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4|
1601773|NCT02781454|2942238|Superiority||linear contrast active vs placebo|0.994||||0.915|2-Sided|95.0|0.876|1.126|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0|
1601774|NCT02781454|2942239|Superiority||linear contrast active vs placebo|0.343||||0.986|2-Sided|95.0|-41.36|42.042|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4|
1601775|NCT02781454|2942240|Superiority||linear contrast active vs placebo|0.411||||0.013|2-Sided|95.0|0.208|0.81|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0|
1601776|NCT02781454|2942241|Superiority||linear contrast active vs placebo|0.792||||0.332|2-Sided|95.0|0.484|1.296||linear contrast active vs placebo|Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo ratio of week 4 to week 0|
1601777|NCT02781454|2942242|Superiority||linear contrast active vs placebo|-5.558||||0.039|2-Sided|95.0|-10.8|-0.315|||Mixed Models Analysis|||Comparison of active (300 and 600 mg) vs placebo for change from baseline to week 4|
1601778|NCT02781311|2942255|Superiority||Least-squares Mean Difference|0.0|Standard Error of the Mean|0.2||0.9101|2-Sided|95.0|-0.42|0.37||P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age, with the Type III sum of squares.|ANCOVA||||
1601779|NCT02781311|2942256|Superiority||Least-squares Mean Difference|0.4|Standard Error of the Mean|4.45||0.9239|2-Sided|95.0|-8.38|9.23||P-values were from analysis of covariance (ANCOVA) model including fixed effects of treatment, and covariates of age and baseline TAHC value, with the Type III sum of squares.|ANCOVA||||
1601780|NCT02780869|2942259|Superiority|The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.||||||0.0001||||||Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.|Regression, Logistic||||
1601781|NCT02780869|2942259|Non-Inferiority|The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.|||||<|0.0001||||||Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.|Regression, Logistic||||
1601782|NCT02780869|2942260|Superiority||||||<|0.0001||||||Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05|Regression, Linear|||The difference in mean preparation time was tested using a linear regression model with stratified adjustment for surgery type.|
1601783|NCT02780869|2942261|Superiority|||||||0.0001||||||Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05|Cochran-Mantel-Haenszel|||A secondary endpoint of superiority of HEMOBLAST relative to G+T for success at achieving hemostasis within 6 minutes was evaluated.|
1601846|NCT02775903|2942514|Superiority|||||||0.1838|||||||Wald asymptotic two-sided test||||
1601888|NCT02766023|2943024|Superiority||Risk Difference (RD)|0.05||||0.446|2-Sided|95.0|-0.07|0.17|||Chi-squared|||Analysis is for compliance assessed by staining.|
1601784|NCT02780869|2942261|Non-Inferiority|The primary endpoint was designed to establish comparable efficacy based upon a non-inferiority margin of 10% for the difference in the probability of TTH within 6 minutes comparing HEMOBLAST™ to G+T (HEMOBLAST™– G+T). Letting θ denote the true difference in the probability of hemostasis at 6 minutes between HEMOBLAST™ to G+T, the trial will test the null hypothesis H0: θ ≤ -0.10 vs. the alternative hypothesis HA : θ > -0.10 using a one-sided level 0.025 test.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified adjustments for surgery type were made using the Cochran-Mantel-Haenszel weighting.|||
1601785|NCT02780856|2942265|Superiority||||||<|0.0001|||||||exact binomial|An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated||The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval|
1601786|NCT02780856|2942265|Superiority||||||<|0.0001|||||||exact binomial|An exact binomial test was used and an exact 97.5% Confidence Level using the Clopper-Pearson method was calculated||The null and alternative hypothesis for each tooth population was of chance agreement (50%) and was tested against an exact binomial one-sided 97.5% confidence interval|
1601787|NCT02780661|2942277|Other||LS mean difference|-0.48||||0.1879|2-Sided|95.0|-1.23|0.261||Log10 change from baseline in anaerobic bacteria microbial count as response variable, treatment and period as fixed effect, participant level and period level pre-treatment microbial count as covariates and participant as random effect.|ANCOVA||Difference is first named treatment minus second named treatment in log10{(count+1)/(baseline+1)} such that a negative difference favors the first named treatment.|H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.|
1601788|NCT02780661|2942278|Other||Least square (LS) mean difference|-0.86||||0.0144|2-Sided|95.0|-1.53|-0.196||Log10 change from baseline in aerobic bacteria microbial count as response variable, treatment and period as fixed effect, participant level and period level pre-treatment microbial count as covariates and participant as random effect.|ANCOVA||Difference is first named treatment minus second named treatment in log10{(count+1)/(baseline+1)} such that a negative difference favors the first named treatment.|H0: There is no treatment difference between daily and weekly product use. H1: There is a treatment difference between daily and weekly product use.|
1601789|NCT02780167|2942335|Other||LS mean difference|-47.35|Standard Error of the Mean|9.008|<|0.0001|2-Sided|90.0|-62.23|-32.47|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 200 mg QD, Reference group: Placebo.||
1601790|NCT02780167|2942335|Other||LS mean difference|-23.82|Standard Error of the Mean|9.043|<|0.0091|2-Sided|90.0|-38.76|-8.88|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 100 mg QD, Reference group: Placebo.||
1601791|NCT02780167|2942335|Other||LS mean difference|-5.52|Standard Error of the Mean|9.474|<|0.561|2-Sided|90.0|-21.16|10.13|||Mixed Models Analysis|MMRM with OC|Test group: PF-04965842 30 mg QD, Reference group: Placebo.||
1601792|NCT02780167|2942335|Other||LS mean difference|4.08|Standard Error of the Mean|9.667|<|0.6731|2-Sided|90.0|-11.88|20.05|||Mixed Models Analysis|Mixed-effects model repeated measures (MMRM) with observed cases (OC)|Test group: PF-04965842 10 mg QD, Reference group: Placebo.||
1601793|NCT02780167|2942336|Other||Mean Difference (Final Values)|38.2|Standard Error of the Mean|7.18||0.0032|2-Sided|95.0|19.7|56.6|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 200 mg QD, Reference group: Placebo.||
1601794|NCT02780167|2942336|Other||Estimate difference|21.5|Standard Error of the Mean|6.25||0.0184|2-Sided|95.0|5.5|37.6|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 100 mg QD, Reference group: Placebo.||
1601795|NCT02780167|2942336|Other||Estimate difference|6.0|Standard Error of the Mean|3.05||0.1065|2-Sided|95.0|-1.8|13.8|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 30 mg QD, Reference group: Placebo.||
1601796|NCT02780167|2942336|Other||Estimate difference|1.8|Standard Error of the Mean|0.99||0.121|2-Sided|95.0|-0.7|4.4|||Emax model|Emax model with non-responder imputation (NRI)|Test group: PF-04965842 10 mg QD, Reference group: Placebo.||
1601797|NCT02779543|2942337|Equivalence|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|74.3|||<|0.001|2-Sided||||||ANOVA||compared to gold standard||
1601798|NCT02779543|2942338|Equivalence|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|106.0|||<|0.001|2-Sided||||||ANOVA||compared to gold standard||
1601799|NCT02779543|2942339|Equivalence|This trial compared those 2 devices with the gold standard (polysomnography)|Mean value|13.9|||<|0.001|2-Sided||||||ANOVA||compared to gold standard||
1601800|NCT02779543|2942340|Equivalence|this trial compared the 2 devices to the polysomnography, which is the gold standard|Mean value|368.3|||<|0.001|2-Sided||||||ANOVA||compared to gold standard||
1601801|NCT02778867|2942349|Other|||||||0.71||||||α < 0.05|Wilcoxon (Mann-Whitney)||||
1601802|NCT02778867|2942350|Other|||||||0.22||||||α < 0.05|t-test, 2 sided|Two sample t-test|||
1601803|NCT02778867|2942351|Other|||||||0.9||||||α < 0.05|Wilcoxon (Mann-Whitney)||||
1601804|NCT02778867|2942354|Other|||||||0.06||||||α < 0.05|Fisher Exact|Two sided|||
1601805|NCT02778867|2942355|Other|||||||0.58||||||α < 0.05|Fisher Exact|Two-sided|||
1601806|NCT02778074|2942375|Superiority||Mean Difference (Final Values)|-2.34|||<|0.001|2-Sided||||||ANCOVA||||
1601807|NCT02777827|2942411|Superiority||Least Square Mean|0.4062|Standard Error of the Mean|0.0451|<|0.0001|2-Sided|95.0|0.317|0.4955|||ANCOVA||||
1601808|NCT02777827|2942411|Superiority||Least Square Mean|0.1701|Standard Error of the Mean|0.045|<|0.0002|2-Sided|95.0|0.081|0.2592|||ANCOVA||||
1601809|NCT02777827|2942411|Superiority||Least Square Mean|0.1056|Standard Error of the Mean|0.0451|<|0.0207|2-Sided|95.0|0.0164|0.1949|||ANCOVA||||
1601810|NCT02777827|2942411|Superiority||Least Square Mean|0.4042|Standard Error of the Mean|0.0453|<|0.0001|2-Sided|95.0|0.3146|0.4938|||ANCOVA||||
1601811|NCT02777827|2942411|Superiority||Least square mean|0.2221|Standard Error of the Mean|0.0453|<|0.0001|2-Sided|95.0|0.1324|0.3118|||ANCOVA||||
1601812|NCT02776904|2942433|Other||||||>|0.05|||||||ANOVA||||
1601813|NCT02776904|2942434|Other||||||>|0.05|||||||ANOVA||||
1601814|NCT02776904|2942435|Other||||||>|0.05|||||||ANOVA||||
1601887|NCT02766023|2943015|Superiority||Odds Ratio (OR)|79.64|||<|0.001|2-Sided|95.0|29.02|218.57|||Chi-squared||||
1601815|NCT02776904|2942436|Other|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in SLS.|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for pairwise comparison between walk status and sex for %GC in SLS.|||
1601816|NCT02776904|2942437|Other|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on percent of gait cycle in DLS.|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for the pairwise comparisons with p<.05.|||
1601817|NCT02776904|2942438|Other|Normality was tested and assumed for all measured gait parameters. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait parameters of step length. Adjusted using Tukey’s post hoc method for the pairwise comparisons (0.05 threshold for significance).|||||<|0.0001|||||||ANOVA|Tukey's post hoc method for the pair wise comparisons between walk status and sex for step length.|||
1601818|NCT02776904|2942439|Other||||||<|0.001||||||Used Tukey's Adjustment|ANOVA|||Descriptive analysis, including means and standard deviations was used to summarize all participant data. Velocity was normalized to leg length. Normality was tested and assumed for all measured gait parameters for healthy athletes. A two-way repeated measure analyses of variance (ANOVA) was used to explore the impact of walk status and sex on gait velocity for healthy athletes. Adjusted using Tukey’s post hoc method for the pairwise comparisons (0.05 threshold for significance)|
1601819|NCT02776904|2942440|Other|||||||0.2637||||||Adjusted for multiple comparisons using Tukey-Kramer|ANOVA|||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Reaction Time|
1601820|NCT02776904|2942441|Other|||||||0.0035||||||Adjusted for multiple comparisons|ANOVA|DF 3||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Motor composite|
1601821|NCT02776904|2942441|Other|||||||0.0281||||||Adjusted for multiple comparisons using Tukey-Kramer|ANOVA|DF 3||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Verbal memory|
1601822|NCT02776904|2942441|Other|||||||0.0003||||||Adjustment with Tukey-Kramer|ANOVA|3 DF||Repeated measures ANOVA compared pre-season scores to post-season, end of the school year and pre-season year 2 for Visual Memory|
1601823|NCT02776670|2942450|Superiority||Mean Difference (Final Values)|-0.8||||0.618|2-Sided|95.0|-6.4|4.7|||MMRM||||
1601824|NCT02776670|2942452|Superiority||Mean Difference (Final Values)|0.118||||0.31|2-Sided|95.0|-0.349|0.585|||MMRM||||
1601825|NCT02776670|2942453|Non-Inferiority|Noninferiority was deemed established if the lower limit of the 95% CI (equivalent to the 1-sided 97.5% CI) for the adjusted estimate of the difference (Systane Balance−Refresh Optive Advanced/Optive Plus) was above the noninferiority margin of −1.0 second.|Mean Difference (Final Values)|0.13|||<|0.0001|2-Sided|95.0|-0.341|0.601||p-value for testing noninferiority of Systane Balance with respect to Refresh Optive Advanced/Refresh Optive Plus is calculated for predefined noninferiority margin of -1.0 second.|Mixed model repeated measures (MMRM)||||
1601826|NCT02775916|2942490|Superiority||Mean Difference (Net)|-7.69|Standard Error of the Mean|10.595|||2-Sided|95.0|-29.75|14.37|||||||
1601827|NCT02775916|2942491|Superiority||Mean Difference (Net)|-10.97|Standard Error of the Mean|9.626|||2-Sided|95.0|-30.94|9.0|||||||
1601828|NCT02775916|2942492|Superiority||Mean Difference (Net)|-6.55|Standard Error of the Mean|7.27|||2-Sided|95.0|-21.76|8.66|||||||
1601829|NCT02775916|2942493|Superiority||Mean Difference (Net)|4.33|Standard Error of the Mean|4.615|||2-Sided|95.0|-5.27|13.93|||||||
1601830|NCT02775916|2942493|Superiority||Mean Difference (Net)|0.4|Standard Error of the Mean|3.119|||2-Sided|95.0|-6.08|6.89|||||||
1601831|NCT02775916|2942494|Superiority||Mean Difference (Net)|0.51|Standard Error of the Mean|1.466|||2-Sided|95.0|-2.52|3.55|||||||
1601832|NCT02775916|2942495|Superiority||Mean Difference (Net)|-0.69|Standard Deviation|1.332|||2-Sided|95.0|-3.343|1.937|||||||
1601833|NCT02775903|2942499|Other|P-values were not part of the formal testing.||||||0.1998|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).|||
1601834|NCT02775903|2942499|Other|P-values were not part of the formal testing.||||||0.7374|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).|||
1601835|NCT02775903|2942501|Other|P-values were not part of the formal testing.||||||0.0765|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).|||
1601836|NCT02775903|2942503|Other|P-values were not part of the formal testing.||||||0.4894|||||||Wald asymptotic two-sided test||||
1601837|NCT02775903|2942504|Other|P-values were not part of the formal testing.||||||0.2092|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).|||
1601838|NCT02775903|2942505|Other|P-values were not part of the formal testing.||||||0.2409|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very intermediate vs poor).|||
1601839|NCT02775903|2942507|Other|P-values were not part of the formal testing.||||||0.9528|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).|||
1601840|NCT02775903|2942508|Other|P-values were not part of the formal testing.||||||0.3648|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).|||
1601841|NCT02775903|2942509|Other|P-values were not part of the formal testing.||||||0.933|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).|||
1601842|NCT02775903|2942510|Other|P-values were not part of the formal testing.||||||0.384|||||||Wald asymptotic two-sided test||||
1601843|NCT02775903|2942511|Other|P-values were not part of the formal testing.||||||0.6076|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).|||
1601844|NCT02775903|2942512|Other|P-values were not part of the formal testing.||||||0.7016|||||||Log Rank|Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor)|||
1601847|NCT02775435|2942525|Superiority||Hazard Ratio (HR)|0.64||||0.0008|2-Sided|95.0|0.49|0.85||Treatment as a covariate stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score [TPS] ≥1% vs. <1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) & geographic region (East Asia vs. non-East Asia)|Regression, Cox||||
1601848|NCT02775435|2942526|Superiority||Hazard Ratio (HR)|0.56|||<|0.0001|2-Sided|95.0|0.45|0.7||Treatment as a covariate stratified by programmed cell death-ligand 1 (PD-L1) status (Tumor Proportion Score [TPS] ≥1% vs. <1%), taxane chemotherapy (paclitaxel vs. nab-paclitaxel) & geographic region (East Asia vs. non-East Asia)|Regression, Cox||||
1601849|NCT02775344|2942532|Superiority||Mean Difference (Final Values)|0.7||||0.393|2-Sided||||||Chi-squared, Corrected||||
1601850|NCT02775344|2942533|Superiority||Mean Difference (Final Values)|4.0||||0.198|2-Sided||||||Chi-squared, Corrected||||
1601851|NCT02775240|2942552|Other||Ratio of geometric means|0.905|||||2-Sided|90.0|0.721|1.138|||||Log-transformed AUClast ratio values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Dextromethorphan/Dextrorphan (Parent/Metabolite) AUClast ratio|
1601852|NCT02775240|2942553|Other||Ratio of geometric means|0.973|||||2-Sided|90.0|0.949|0.998|||||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast for Dextrorphan|
1601853|NCT02775240|2942554|Other||Ratio of geometric means|0.882|||||2-Sided|90.0|0.696|1.118|||||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast of Dextromethorphan|
1601854|NCT02775240|2942555|Other||Ratio of geometric means|1.179|||||2-Sided|90.0|1.08|1.287|||||Log-transformed AUClast values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUClast for Digoxin|
1601855|NCT02775240|2942556|Other||Ratio of geometric means|0.971|||||2-Sided|90.0|0.943|0.999|||||Log-transformed AUC0-infinity values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUC0-infinity of Dextrorphan|
1601856|NCT02775240|2942558|Other||Ratio of geometric means|1.206|||||2-Sided|90.0|1.099|1.324|||||Log-transformed AUC0-infinity values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for AUC0-infinity of Digoxin|
1601857|NCT02775240|2942564|Other||Ratio of geometric means|0.943|||||2-Sided|90.0|0.883|1.007|||||Log-transformed Cmax values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Cmax of Dextrorphan|
1601858|NCT02775240|2942565|Other||Ratio of geometric means|0.944|||||2-Sided|90.0|0.778|1.144||||||Comparison of Treatment B over Treatment A for Cmax of Dextromethorphan|
1601859|NCT02775240|2942566|Other||Ratio of geometric means|1.248|||||2-Sided|90.0|1.13|1.378|||||Log-transformed Cmax values were compared between treatment regimens using a linear mixed effects model with treatment regimen as fixed effect and participant as random effect.|Comparison of Treatment B over Treatment A for Cmax of Digoxin|
1601860|NCT02774616|2942588|Non-Inferiority|A rejection of the null hypothesis (Ho) would demonstrate evidence that the rate of appropriate pacing is greater than 93.0% in the population.|||||<|0.0001|||||||exact binomial|||"This secondary hypothesis evaluates the rate of appropriate right ventricular pacing of all patients in which a pacing measurement was performed. The following hypothesis has been defined:~Ho: Rate of appropriate pacing through 3 months post-implant ≤ 93.0% Ha: Rate of appropriate pacing through 3 months post-implant > 93.0%"|
1601861|NCT02774616|2942589|Non-Inferiority|This endpoint evaluates the rate of appropriate right ventricular sensing of all patients in which a sensing measurement was performed. The following hypothesis has been defined: Ho: Rate of appropriate sensing through 3 months post-implant ≤ 93.0% Ha: Rate of appropriate sensing through 3 months post-implant > 93.0%|||||<|0.0001||||||A rejection of the null hypothesis (Ho) would demonstrate evidence that the rate of appropriate sensing is greater than 93.0% in the population.|exact binomial||||
1601862|NCT02774616|2942591|Non-Inferiority|A rejection of the null hypothesis (Ho) would demonstrate evidence that the complication-free rate is greater than 90.0% in the population.||||||0.0019|||||||exact binomial|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Plexa ICD lead until the 6-month follow-up are counted for this primary endpoint. The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant > 90.0%"|
1601863|NCT02774616|2942592|Non-Inferiority|A rejection of the null hypothesis (Ho) would demonstrate evidence that the complication-free rate is greater than 90.0% in the population.||||||0.0004|||||||exact binomial|||"Serious Adverse Device Effects (SADE) possibly or securely related to the Ilivia ICD family until the 3- month follow-up are counted for this primary endpoint. The following hypothesis has been defined:~Ho: SADE-free rate through 3 months post-implant ≤ 90.0% Ha: SADE-free rate through 3 months post-implant > 90.0%"|
1601864|NCT02773758|2942645|Superiority or Other||Least square (LS) mean difference|-1.29|||<|0.0001|2-Sided|95.0|-1.509|-1.071|||ANCOVA|From ANCOVA model with change from baseline in Schiff Sensitivity Score as response and treatment and baseline Schiff sensitivity score as covariates.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.||
1601865|NCT02773368|2942692|Superiority|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change, number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and change in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in insulin dose after 26 weeks was strictly below 0 U.|Treatment Contrast|-15.37|||||2-Sided|95.0|-19.6|-11.13|||||IDegLira minus IGlar|The endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline HbA1c as covariate. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.|
1601866|NCT02773368|2942693|Superiority|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c and superiority of IDegLira was confirmed for change from baseline in body weight) and if the upper limit of the two-sided 95% CI for the rate ratio (IDegLira over IGlar) of rate of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes was strictly below 1.|Treatment Ratio|0.42|||||2-Sided|95.0|0.23|0.75|||||IDegLira over IGlar|This endpoint was analysed using a negative binomial regression model with a log link and the logarithm of the exposure time as offset. The model included treatment and pre-trial OAD as fixed factors. Missing data were imputed using multiple imputations (conditioning on expected event rate before premature treatment discontinuation or withdrawal from trial as if treated with IGlar).|
1601867|NCT02773368|2942694|Superiority|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in body weight was strictly below 0 kg.|Treatment Contrast|-1.92|||||2-Sided|95.0|-2.64|-1.19|||||IDegLira minus IGlar|This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline weight as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.|
1601868|NCT02773368|2942695|Superiority|Superiority of IDegLira was considered confirmed if the test procedure was not stopped (i.e. non-inferiority of IDegLira was confirmed for change from baseline in HbA1c; and superiority of IDegLira was confirmed for weight change and the number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes) and if the upper limit of the two-sided 95% CI for the mean treatment difference (IDegLira minus IGlar) in change from baseline in HbA1c was strictly below 0%.|Treatment Contrast|-0.36|||||2-Sided|95.0|-0.5|-0.21|||||IDegLira minus IGlar|This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline value as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.|
1601869|NCT02773368|2942695|Non-Inferiority|Non-inferiority of IDegLira was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (IDegLira minus IGlar) was strictly below 0.3%.|Treatment Contrast|-0.34|||||2-Sided|95.0|-0.48|-0.2|||||IDegLira minus IGlar|Analysis was based on ANCOVA model with treatment, pre-trial OAD, region as factors and baseline HbA1c as covariate. Data obtained after premature treatment discontinuation are included in the analysis. Missing data was imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation. The non-inferiority margin of 0.3 % was added to the end-of-treatment value for prematurely discontinued and withdrawn from trial IDegLira subjects.|
1601870|NCT02770612|2942774|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||We used a one sided one sample Wilcoxon test to compare the median number of oxycodone tablets chosen and prescribed to the institutional standard of 40 tablets of oxycodone 5mg on discharge|
1601871|NCT02769858|2942794|Other|||||||0.502|||||||t-test, 2 sided||||
1601872|NCT02769858|2942795|Other|||||||0.019|||||||t-test, 2 sided||||
1601873|NCT02769858|2942796|Other|||||||0.001|||||||t-test, 2 sided||||
1601874|NCT02769312|2942801|Superiority||Effect size (cohen's d)|0.39||||0.04|2-Sided||||||ANCOVA||||
1601875|NCT02769312|2942802|Superiority||Effect size (cohen's d)|0.12||||0.61|2-Sided||||||ANCOVA||||
1601876|NCT02769312|2942803|Other||Effect size (cohen's d)|0.16||||0.46|2-Sided||||||ANCOVA||||
1601877|NCT02768194|2942916|Superiority||Mean Difference (Net)|-0.1||||0.583|2-Sided|95.0|-0.46|0.26||From the MMRM model with change from pre-dose as response, subject as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.||
1601878|NCT02768194|2942916|Superiority||Mean Difference (Net)|-0.01||||0.9671|2-Sided|95.0|-0.36|0.35||From the MMRM model with change from pre-dose as response, subject as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.||
1601879|NCT02768194|2942916|Superiority||Mean Difference (Net)|-0.11||||0.5512|2-Sided|95.0|-0.46|0.25||From the MMRM model with change from pre-dose as response, participant as a random effect; and treatment, period, day, location of sample in mouth (left or right) and treatment×day interaction as fixed effects; pre-dose mean SEM score as covariate.|Mixed Models Analysis||Difference is the first named treatment minus second named treatment such that a negative difference favours the first named treatment.||
1601880|NCT02767427|2942935|Equivalence|An equivalence test on data from a parallel-group design with sample sizes of 18 in the reference group and 18 in the treatment group achieves 80% power. The significance was set at 5%. The standard deviation was 1.00, and the equivalence limits were set at -1.00 and 1.00.|||||<|0.05|||||||t-test, 1 sided|Two one-sided t-tests were conducted with 18 in each group.|||
1601881|NCT02766400|2942979|Superiority or Other (legacy)||Cohen's d effect size at 12 months|0.53|||<|0.001|2-Sided|95.0|-0.12|1.19||a priori threshold was set at p<0.05|Linear mixed models|F(4,150)=5.11|Effect size was calculated using mean change scores (baseline to month 12) and standard error of change (baseline to month 12) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.|
1601882|NCT02766374|2942980|Superiority||||||>|0.1|||||||GEE regression||||
1601883|NCT02766283|2942987|Superiority or Other|||||||0.022|||||||Chi-squared||||
1601884|NCT02766283|2942988|Superiority or Other|||||||0.9|||||||Chi-squared||||
1601885|NCT02766023|2943006|Superiority||Odds Ratio (OR)|0.54||||0.03|2-Sided|95.0|0.31|0.94|||Chi-squared||||
1601886|NCT02766023|2943007|Superiority||Odds Ratio (OR)|72.78|||<|0.001|2-Sided|95.0|28.07|188.66|||Chi-squared||||
1669899|NCT01387815|3072829|Other|||||||0.807|||||||t-test, 2 sided||||
1601890|NCT02766023|2943025|Superiority||Odds Ratio (OR)|0.54||||0.031|2-Sided|95.0|0.3|0.95|||Chi-squared||||
1601891|NCT02766023|2943026|Superiority||Risk Difference (RD)|0.04||||0.467|2-Sided|95.0|-0.1|0.18|||Fisher Exact||||
1601892|NCT02763579|2943151|Superiority||Stratified Hazard Ratio|0.7||||0.0069|2-Sided|95.0|0.54|0.91|||Log Rank||||
1601893|NCT02763579|2943152|Superiority||Stratified Hazard Ratio|0.77||||0.017|2-Sided|95.0|0.62|0.96|||Log Rank||||
1601894|NCT02763566|2943154|Superiority||LSMean Difference|-2.42|Standard Error of the Mean|2.38||0.31|2-Sided|95.0|-7.12|2.28|||Mixed Models Analysis|||Functional Scales - Cognitive functioning|
1601895|NCT02763566|2943154|Superiority||LSMean Difference|2.99|Standard Error of the Mean|3.14||0.342|2-Sided|95.0|-3.21|9.19|||Mixed Models Analysis|||Symptom Scales - Financial DIfficulties|
1601896|NCT02763566|2943154|Superiority||LSMean Difference|17.83|Standard Error of the Mean|2.32||0|2-Sided|95.0|13.25|22.41|||Mixed Models Analysis|||Symptom Scales - Diarrhoea|
1601897|NCT02763566|2943154|Superiority||LSMean Difference|-2.28|Standard Error of the Mean|2.29||0.321|2-Sided|95.0|-6.83|2.27|||Mixed Models Analysis|||Symptom Scales - Constipation|
1601898|NCT02763566|2943154|Superiority||LSMean Difference|7.46|Standard Error of the Mean|2.92||0.012|2-Sided|95.0|1.68|13.23|||Mixed Models Analysis|||Symptom Scales - Appetite|
1601899|NCT02763566|2943154|Superiority||LSMean Difference|1.97|Standard Error of the Mean|2.9||0.499|2-Sided|95.0|-3.78|7.72|||Mixed Models Analysis|||Symptom Scales - Insomnia|
1601900|NCT02763566|2943154|Superiority||LSMean Difference|-2.49|Standard Error of the Mean|4.39||0.28|2-Sided|95.0|-7.04|2.06|||Mixed Models Analysis|||Symptom Scales - Dyspnoea|
1601901|NCT02763566|2943154|Superiority||LSMean Difference|-2.66|Standard Error of the Mean|2.42||0.275|2-Sided|95.0|-7.45|2.14|||Mixed Models Analysis|||Symptom Scales - Pain|
1601902|NCT02763566|2943154|Superiority||LSMean Difference|2.59|Standard Error of the Mean|1.99||0.194|2-Sided|95.0|-1.33|6.52|||Mixed Models Analysis|||Symptom Scales - Nausea and Vomiting|
1601903|NCT02763566|2943154|Superiority||LSMean Difference|2.73|Standard Error of the Mean|2.52||0.281|2-Sided|95.0|-2.26|7.72|||Mixed Models Analysis|||Symptom Scales - Fatigue|
1601904|NCT02763566|2943154|Superiority||LSMean Difference|0.64|Standard Error of the Mean|2.98||0.83|2-Sided|95.0|-5.26|6.55|||Mixed Models Analysis|||Functional Scales - Social Functioning|
1601905|NCT02763566|2943154|Superiority||LSMean Difference|-2.42|Standard Error of the Mean|0.31||0.31|2-Sided|95.0|-7.12|2.28|||Mixed Models Analysis|||Functional Scales - Emotional Functioning|
1601906|NCT02763566|2943154|Superiority||LSMean Difference|-1.72|Standard Error of the Mean|2.38||0.472|2-Sided|95.0|-6.42|2.99|||Mixed Models Analysis|||Functional Scales - Role functioning|
1601907|NCT02763566|2943154|Superiority||LSMean Difference|1.58|Standard Error of the Mean|1.87||0.4|2-Sided|95.0|-2.12|5.29|||Mixed Models Analysis|||Functional Scales - Physical Functioning|
1601908|NCT02763566|2943154|Superiority||LSMean Difference|-3.47|Standard Error of the Mean|2.51||0.169|2-Sided|95.0|-8.43|1.49|||Mixed Models Analysis|||Global Health Status|
1601909|NCT02763566|2943154|Superiority||LSMean Difference|-1.75|Standard Error of the Mean|2.97||0.557|2-Sided|95.0|-7.59|4.1|||Mixed Models Analysis|||Symptom Scales - Financial Difficulties|
1601910|NCT02763566|2943154|Superiority||LSMean Difference|15.82|Standard Error of the Mean|1.53||0|2-Sided|95.0|12.81|18.84|||Mixed Models Analysis|||Symptom Scales - Diarrhoea|
1601911|NCT02763566|2943154|Superiority||LSMean Difference|-1.57|Standard Error of the Mean|1.76||0.375|2-Sided|95.0|-5.04|1.91|||Mixed Models Analysis|||Symptom Scales - Constipation|
1601912|NCT02763566|2943154|Superiority||LSMean Difference|5.65|Standard Error of the Mean|1.74||0.001|2-Sided|95.0|2.23|9.07|||Mixed Models Analysis|||Symptom Scales - Appetite|
1601913|NCT02763566|2943154|Superiority||LSMean Difference|-0.81|Standard Error of the Mean|1.92||0.673|2-Sided|95.0|-4.6|2.97|||Mixed Models Analysis|||Symptom scales - Insomnia|
1601914|NCT02763566|2943154|Superiority||LSMean Difference|2.16|Standard Error of the Mean|1.84||0.24|2-Sided|95.0|-1.46|5.78|||Mixed Models Analysis|||Symptom Scales - Dyspnoea|
1601915|NCT02763566|2943154|Superiority||LSMean Difference|0.74|Standard Error of the Mean|1.63||0.74|2-Sided|95.0|-3.75|2.66|||Mixed Models Analysis|||Symptom Scales - Pain|
1601916|NCT02763566|2943154|Superiority||LSMean Difference|0.95|Standard Error of the Mean|1.06||0.372|2-Sided|95.0|-1.14|3.03|||Mixed Models Analysis|||Symptom Scales - Nausea and Vomiting|
1601917|NCT02763566|2943154|Superiority||LSMean Difference|1.57|Standard Error of the Mean|1.7||0.355|2-Sided|95.0|-1.77|4.91|||Mixed Models Analysis|||Symptom Scales - Fatigue|
1601918|NCT02763566|2943154|Superiority||LSMean Difference|-0.88|Standard Error of the Mean|2.12||0.678|2-Sided|95.0|-5.05|3.29|||Mixed Models Analysis||||
1601919|NCT02763566|2943154|Superiority||LSMean Difference|-2.17|Standard Error of the Mean|1.62||0.182|2-Sided|95.0|-5.37|1.03|||Mixed Models Analysis|||Functional Scales - Cognitive Functioning|
1601920|NCT02763566|2943154|Superiority||LSMean Difference|1.67|Standard Error of the Mean|1.74||0.34|2-Sided|95.0|-1.77|5.1|||Mixed Models Analysis|||Functional Scales - Emotional Functioning|
1601921|NCT02763566|2943154|Superiority||LSMean Difference|-0.31|Standard Error of the Mean|2.15||0.885|2-Sided|95.0|-4.55|3.93|||Mixed Models Analysis|||Functional Scales - Role Functioning|
1601922|NCT02763566|2943154|Superiority||LSMean Difference|-0.77|Standard Error of the Mean|1.46||0.597|2-Sided|95.0|-3.64|2.1|||Mixed Models Analysis|||Functional Scales - Physical functioning|
1601923|NCT02763566|2943154|Superiority||LSMean Difference|-1.89|Standard Error of the Mean|1.77||0.287|2-Sided|95.0|-5.36|1.59|||Mixed Models Analysis|||Global Health Status|
1601924|NCT02763566|2943155|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1601925|NCT02763566|2943155|Superiority||||||<|0.0003|||||||Cochran-Mantel-Haenszel||||
1601926|NCT02763566|2943156|Superiority|||||||0.0004|||||||Cochran-Mantel-Haenszel||||
1601927|NCT02763566|2943156|Superiority|||||||0.0456|||||||Cochran-Mantel-Haenszel||||
1601928|NCT02763566|2943158|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1601929|NCT02763566|2943158|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1601930|NCT02763566|2943160|Superiority||Hazard Ratio (HR)|0.376|||<|0.0001|2-Sided|95.0|0.24|0.588|||Log Rank||||
1601931|NCT02763566|2943161|Superiority||Hazard Ratio (HR)|0.499||||0.0001|2-Sided|95.0|0.346|0.719|||Log Rank||||
1601932|NCT02762578|2943232|Superiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 6: Superiority with respect to subjects achieving HbA1c < 7% at end of trial without confirmed hypoglycaemia for IDegAsp vs. BIAsp 30 (provided that superiority with respect to change from baseline in body weight was confirmed).~Superiority was considered confirmed if the 95% CI for the odds ratio (IDegAsp group/BIAsp 30 group) was entirely above one."|Treatment Ratio|2.22||||0.0002|2-Sided|95.0|1.47|3.35||Two-sided p-value for testing difference|Regression, Logistic|||The endpoint was analysed in a logistic regression model using a logit link, including treatment, sex and anti-diabetic treatment at screening as fixed effects, and age and HbA1c as covariates.|
1601933|NCT02762578|2943233|Superiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 5: Superiority with respect to change from baseline in body weight for IDegAsp vs. BIAsp 30 (provided that Superiority with respect to confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 was confirmed).~Superiority was considered confirmed if the 95% CI for the treatment difference (IDegAsp group−BIAsp 30 group) was entirely below zero"|Treatment contrast|0.61||||0.0092|2-Sided|95.0|0.15|1.08|||ANCOVA|Two-sided p-value for testing difference||The response and change from baseline in response after 26 weeks were analysed using an ANCOVA model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate.|
1601934|NCT02762578|2943234|Superiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: Superiority with respect to confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 (provided that superiority with respect to nocturnal confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 was confirmed).~Superiority was considered confirmed if the 95% CI for the rate ratio (IDegAsp group/BIAsp 30 group) was entirely below one."|Treatment Ratio|0.57||||0.0002|2-Sided|95.0|0.42|0.77|||Negative binomial regression model|||The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate|
1601935|NCT02762578|2943235|Superiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: Superiority with respect to nocturnal confirmed hypoglycaemic episodes for IDegAsp vs. BIAsp 30 (provided that superiority with respect to change from baseline in FPG to week 26 was confirmed for IDegAsp vs. BIAsp 30).~Superiority was considered confirmed if the 95% CI for the rate ratio (IDegAsp group/BIAsp 30 group) was entirely below one."|Treatment Ratio|0.53||||0.0112|2-Sided|95.0|0.33|0.87|||Negative binomial regression model|||The number of events was analysed using a Negative Binomial Model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate.|
1601936|NCT02762578|2943236|Superiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Superiority with respect to change from baseline in FPG to week 26 for IDegAsp vs. BIAsp 30 (Provided that non-inferiority was confirmed for the primary endpoint)~Superiority was considered confirmed if the 95% CI for the treatment difference (IDegAsp group−BIAsp 30 group) was entirely below zero."|Treatment Contrast|-1.42|||<|0.0001|2-Sided|95.0|-1.74|-1.1||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in FPG after 26 weeks of treatment was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline FPG as covariates.|
1601937|NCT02762578|2943237|Superiority|"If non-inferiority was confirmed, the superiority of the IDegAsp group over the BIAsp 30 group was to be investigated.~Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval, which was calculated using the FAS, was below 0%."|Treatment contrast|-0.08||||0.243|2-Sided|95.0|-0.2|0.05||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.|
1601938|NCT02762578|2943237|Non-Inferiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: Non-inferiority with respect to change from baseline in HbA1c (%) to week 26 for IDegAsp vs. BIAsp 30.~Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%."|Treatment contrast|-0.08||||0.243|2-Sided|95.0|-0.2|0.05||Two-sided p-value for testing difference|ANCOVA|||Change from baseline in HbA1c after 26 weeks of treatments was analysed using an ANCOVA method with treatment, anti-diabetic therapy at screening and sex as fixed factors, and age and baseline HbA1c as covariates.|
1601939|NCT02762500|2943239|Superiority||Mean Difference (Final Values)|0.18||||0.708|2-Sided|90.0|-0.6|0.95|||ANCOVA|The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.|||
1601940|NCT02762500|2943240|Superiority||Mean Difference (Final Values)|-44.59||||0.032|2-Sided|90.0|-78.66|-10.53|||ANCOVA|The mean change from baseline at Week 8 was analyzed using ANCOVA with a factor for treatment and a covariate for baseline scores.||Subjects included in this analysis were those with a baseline fecal calprotectin value ≥ 250 µg/g.|
1601941|NCT02762500|2943241|Superiority||Risk Difference (RD)|-9.7||||0.14|2-Sided|90.0|-24.3|5.0||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.|
1601942|NCT02762500|2943242|Superiority||Risk Difference (RD)|-6.5||||0.235|2-Sided|90.0|-21.1|8.2||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.|
1601998|NCT02761733|2943286|Superiority or Other||Mean Difference (Net)|-0.437||||0.0338|2-Sided|95.0|-0.837|-0.037||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 165||
1601943|NCT02762500|2943243|Superiority||Risk Difference (RD)|-8.1||||0.106|2-Sided|90.0|-18.6|2.5||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.|
1601944|NCT02762500|2943244|Superiority||Risk Difference (RD)|-8.1||||0.106|2-Sided|90.0|-18.6|2.5||one-sided p-value|Chi-squared|Statistical test was a one-sided performed at the 5% level of significance. Pearson chi-square test was used to test the null hypothesis.|90% CI obtained based on normal approximation.|The response rate difference is the mean difference in response rates between the treatment and placebo responders. The p-value is based on one-sided Pearson chi-square test.|
1601945|NCT02762370|2943251|Superiority|||||||0.0452|||||||t-test, 2 sided||||
1601946|NCT02762084|2943263|Other|Two-sided comparison||||||0.008|||||||Mann Whitey U|||at Week 26|
1601947|NCT02762084|2943264|Other|Two-sided comparison||||||0.096|||||||Mann Whitey U|||at Week 26|
1601948|NCT02762084|2943264|Other|One-sided comparison||||||0.048|||||||Mann Whitey U|||at Week 26|
1601949|NCT02762084|2943268|Other|Pairwise comparison||||||0.681|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 6|
1601950|NCT02762084|2943268|Other|Pairwise comparison||||||0.5|||||||ANCOVA|ANCOVA with treatment group as a factor and using Baseline value as a covariate||at Week 6|
1601951|NCT02762084|2943269|Other|Pairwise comparison||||||0.756|||||||ANCOVA|ANCOVA with treatment group as a factor and Baseline value as a covariate||at Week 26|
1601952|NCT02762084|2943269|Other|Pairwise comparison||||||0.03|||||||ANCOVA|ANCOVA with treatment group as a factor and Baseline value as a covariate||at Week 26|
1601953|NCT02761980|2943277|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.01||||0.965|2-Sided|95.0|-0.58|0.55|||ANCOVA||||
1601954|NCT02761980|2943277|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.53||||0.202|2-Sided|95.0|-0.28|1.34|||ANCOVA||||
1601955|NCT02761980|2943277|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.51||||0.212|2-Sided|95.0|-0.29|1.32|||ANCOVA||||
1601956|NCT02761980|2943277|Superiority||LSM difference|0.15||||0.614|2-Sided|95.0|-0.43|0.72|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|
1601957|NCT02761980|2943277|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.16||||0.582|2-Sided|95.0|-0.41|0.73|||ANCOVA||||
1601958|NCT02761980|2943277|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.67||||0.101|2-Sided|95.0|-0.13|1.48|||ANCOVA||||
1601959|NCT02761980|2943278|Superiority|||||||0.997||||||P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model.|Hazard Ratio||||
1601960|NCT02761980|2943278|Superiority|||||||0.998||||||P-value, HR and corresponding 95% CI were calculated based on the PH model with treatment term in the model.|Hazard Ratio||||
1601961|NCT02761980|2943278|Superiority|||||||0.997||||||P-value, hazard ratio (HR) and corresponding 95% CI were calculated based on the proportional hazards (PH) model with treatment term in the model.|hazard ratio||||
1601962|NCT02761980|2943279|Superiority|||||||0.191||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank||||
1601963|NCT02761980|2943279|Superiority|||||||0.514||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank||||
1601964|NCT02761980|2943279|Superiority|||||||0.671||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank||||
1601965|NCT02761980|2943279|Superiority|||||||0.822||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank||||
1601966|NCT02761980|2943279|Superiority|||||||0.142||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank||||
1601967|NCT02761980|2943279|Superiority|||||||0.449||||||Generalized log-rank test based on interval-censored survival analysis using nonparametric survival method.|Log Rank||||
1601968|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.09||||0.865|2-Sided|95.0|-1.12|0.94|||ANCOVA|||WSTD 0-6 hours|
1601969|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.92||||0.011|2-Sided|95.0|0.45|3.39|||ANCOVA|||WSTD 0-6 hours|
1601970|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.83||||0.014|2-Sided|95.0|0.37|3.29|||ANCOVA|||WSTD 0-6 hours|
1601971|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.7||||0.186|2-Sided|95.0|-0.34|1.74|||ANCOVA|||WSTD 0-6 hours|
1601972|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.79||||0.135|2-Sided|95.0|-0.25|1.82|||ANCOVA|||WSTD 0-6 hours|
1602051|NCT02758119|2943464|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1602052|NCT02757963|2943466|Other||Kappa statistic|0.55|||||2-Sided|95.0|0.51|0.58|||||||
1601973|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.62|||<|0.001|2-Sided|95.0|1.16|4.08|||ANCOVA|||WSTD 0-6 hours|
1601974|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.16|||<|0.659|2-Sided|95.0|-0.87|0.55|||ANCOVA|||WSTD 0-4 hours|
1601975|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.42|||<|0.006|2-Sided|95.0|0.4|2.44|||ANCOVA|||WSTD 0-4 hours|
1601976|NCT02761980|2943280|Superiority||LSM difference|1.26|||<|0.015|2-Sided|95.0|0.24|2.27||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|ANCOVA|||WSTD 0-4 hours|
1601977|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.45|||<|0.217|2-Sided|95.0|-0.27|1.17|||ANCOVA|||WSTD 0-4 hours|
1601978|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.61|||<|0.094|2-Sided|95.0|-0.1|1.33|||ANCOVA|||WSTD 0-4 hours|
1601979|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|1.87|||<|0.001|2-Sided|95.0|0.86|2.88|||ANCOVA|||WSTD 0-4 hours|
1601980|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|-0.09|||<|0.692|2-Sided|95.0|-0.52|0.34|||ANCOVA|||WSTD 0-2 hours|
1601981|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.6|||<|0.054|2-Sided|95.0|-0.01|1.21|||ANCOVA|||WSTD 0-2 hours|
1601982|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.51|||<|0.098|2-Sided|95.0|-0.1|1.13|||ANCOVA|||WSTD 0-2 hours|
1601983|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.3|||<|0.172|2-Sided|95.0|-0.13|0.74|||ANCOVA|||WSTD 0-2 hours|
1601984|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.39|||<|0.078|2-Sided|95.0|-0.04|0.82|||ANCOVA|||WSTD 0-2 hours|
1601985|NCT02761980|2943280|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|0.9|||<|0.004|2-Sided|95.0|0.29|1.51|||ANCOVA|||WSTD 0-2 hours|
1601986|NCT02761980|2943281|Superiority||LSM difference|-0.12||||0.864|2-Sided|95.0|-1.54|1.29|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|
1601987|NCT02761980|2943281|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.35||||0.023|2-Sided|95.0|0.33|4.37|||ANCOVA||||
1601988|NCT02761980|2943281|Superiority|Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|LSM difference|2.23||||0.03|2-Sided|95.0|0.22|4.25|||ANCOVA||||
1601989|NCT02761980|2943281|Superiority||LSM difference|0.79||||0.28|2-Sided|95.0|-0.64|2.21|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|
1601990|NCT02761980|2943281|Superiority||LSM difference|0.91||||0.21|2-Sided|95.0|-0.52|2.33|||ANCOVA|||Treatment difference and 95 % CI were based on LSM from ANCOVA with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|
1601991|NCT02761980|2943281|Superiority||LSM difference|3.14||||0.002|2-Sided|95.0|1.13|5.15|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) were based on Least Square Mean (LSM) from analysis of covariance (ANCOVA) with treatment, and covariates time from the first RSE full dose to randomization, and baseline temperature.|
1601992|NCT02761967|2943284|Equivalence|The statistical power of the study for the temporal variables was 82%. Multiple linear regression models were obtained for the first and second stages and for the total duration of delivery.||||||0.776|||||||Chi-squared||||
1601993|NCT02761733|2943285|Superiority or Other||Mean Difference (Net)|-0.3793||||0.0009|2-Sided|95.0|-0.599|-0.1596||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 172||
1601994|NCT02761733|2943285|Superiority or Other||Mean Difference (Net)|-0.2338||||0.0619|2-Sided|95.0|-0.4778|0.0102||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 186||
1601995|NCT02761733|2943285|Superiority or Other||Mean Difference (Net)|0.0401||||0.7407|2-Sided|95.0|-0.1969|0.2771||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 194||
1601996|NCT02761733|2943285|Superiority or Other||Mean Difference (Net)|-0.2967||||0.0283|2-Sided|95.0|-0.5599|-0.0335||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 213||
1601997|NCT02761733|2943286|Superiority or Other||Mean Difference (Net)|-0.2564||||0.1555|2-Sided|95.0|-0.6086|0.0958||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 157||
1669900|NCT01387815|3072830|Other|||||||0.501|||||||t-test, 2 sided||||
1601999|NCT02761733|2943286|Superiority or Other||Mean Difference (Net)|0.2258||||0.2518|2-Sided|95.0|-0.1591|0.6107||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 173||
1602000|NCT02761733|2943286|Superiority or Other||Mean Difference (Net)|-0.026||||0.9046|2-Sided|95.0|-0.4507|0.3987||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 182||
1602001|NCT02761733|2943287|Superiority or Other||Mean Difference (Net)|0.0576||||0.7677|2-Sided|95.0|-0.3238|0.439||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 131||
1602002|NCT02761733|2943287|Superiority or Other||Mean Difference (Net)|0.3192||||0.1074|2-Sided|95.0|-0.0667|0.7051||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 129||
1602003|NCT02761733|2943287|Superiority or Other||Mean Difference (Net)|0.2642||||0.2404|2-Sided|95.0|-0.1754|0.7038||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 184||
1602004|NCT02761733|2943287|Superiority or Other||Mean Difference (Net)|-0.1241||||0.584|2-Sided|95.0|-0.5675|0.3193||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 142||
1602005|NCT02761733|2943288|Superiority or Other||Mean Difference (Net)|3.7297||||0.3126|2-Sided|95.0|-3.4864|10.9458||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis||Satterthwaite adjusted df = 163|a priori test|
1602006|NCT02761733|2943288|Superiority or Other||Mean Difference (Net)|-8.9703||||0.0343|2-Sided|95.0|-17.2107|-0.7299||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis|Satterthwaite adjusted df = 166|Satterthwaite adjusted df = 166|a priori test|
1602007|NCT02761733|2943288|Superiority or Other||Mean Difference (Net)|4.3959||||0.2633|2-Sided|95.0|-2.2237|11.0155||Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Mixed Models Analysis|Satterthwaite adjusted df = 169||a priori test|
1602008|NCT02761733|2943288|Superiority or Other||Mean Difference (Net)|-1.9284||||0.6588|2-Sided|95.0|-10.4728|6.616||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 175||
1602009|NCT02761733|2943289|Superiority or Other||Mean Difference (Net)|-1.6237||||0.333|2-Sided|95.0|-4.9|1.6526||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 143||
1602010|NCT02761733|2943289|Superiority or Other||Mean Difference (Net)|2.541||||0.1878|2-Sided|95.0|-1.2234|6.3054||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 153||
1602011|NCT02761733|2943289|Superiority or Other||Mean Difference (Net)|-0.3087||||0.876|2-Sided|95.0|-4.1799|3.5625||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 166||
1602012|NCT02761733|2943289|Superiority or Other||Mean Difference (Net)|-3.4524||||0.0988|2-Sided|95.0|-7.5302|0.6254||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 180||
1602013|NCT02761733|2943290|Superiority or Other||Mean Difference (Net)|0.2798||||0.8532|2-Sided|95.0|-2.6771|3.2367||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 136||
1602014|NCT02761733|2943290|Superiority or Other||Mean Difference (Net)|-1.0139||||0.5588|2-Sided|95.0|-4.4957|2.3779||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 148||
1602015|NCT02761733|2943290|Superiority or Other||Mean Difference (Net)|-2.882||||0.0999|2-Sided|95.0|-6.2957|0.5317||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 165||
1602016|NCT02761733|2943290|Superiority or Other||Mean Difference (Net)|-3.3652||||0.0679|2-Sided|95.0|-6.9559|0.2255||a priori test|Mixed Models Analysis|Least Squares Mean Difference Test using LSMEANS pdiff test in SAS PROC MIXED 9.4|Satterthwaite adjusted df = 173||
1602017|NCT02761629|2943303|Superiority or Other|||||||0.0175|||||||Fisher Exact||||
1602018|NCT02761629|2943306|Superiority or Other||Difference in Response Rates|12.7||||0.0536|2-Sided|95.0|-0.01|26.6|||Fisher Exact||Exact 95% confidence interval was from the binomial distribution for response rate.||
1602019|NCT02761252|2943307|Superiority||Median Difference (Final Values)|-0.837|Standard Error of the Mean|2.5735||0.7452|2-Sided|95.0|-5.8968|4.2228|||ANOVA||||
1602020|NCT02761252|2943308|Other||Mean Difference (Final Values)|0.8359|Standard Error of the Mean|0.9322||0.3704|2-Sided|95.0|-0.9969|2.6688|||ANOVA||||
1602021|NCT02761252|2943309|Superiority||Mean Difference (Final Values)|-0.03615|Standard Error of the Mean|0.1504||0.81032|2-Sided|95.0|-0.3319|0.2596|||ANCOVA||||
1602022|NCT02761252|2943310|Superiority||Mean Difference (Final Values)|-0.1393|Standard Error of the Mean|0.2009||0.4885|2-Sided|95.0|-0.5342|0.2557|||ANCOVA||||
1602023|NCT02761252|2943311|Superiority||Mean Difference (Final Values)|-1.1552|Standard Error of the Mean|0.4489||0.0105|2-Sided|95.0|-2.0379|-0.2725|||ANCOVA||||
1602024|NCT02761252|2943312|Superiority||Mean Difference (Final Values)|-0.194|Standard Error of the Mean|0.3429||0.5721|2-Sided|95.0|-0.8693|0.4813|||ANCOVA||||
1602025|NCT02760654|2943321|Superiority||||||>|0.05|||||||ANCOVA||||
1602026|NCT02760654|2943322|Superiority||||||>|0.05|||||||ANCOVA||||
1602027|NCT02760654|2943323|Equivalence|Descriptive statistics (Mean, SD) were calculated for the 7 items of the Adapted Acceptability E-Scale|Calculated Mean and Standard Deviation|0.05|||||2-Sided||||||||||
1602028|NCT02760654|2943324|Superiority||||||>|0.05|||||||ANCOVA||||
1602029|NCT02760654|2943325|Superiority||||||>|0.05|||||||Fisher Exact||||
1602030|NCT02760654|2943326|Superiority||||||>|0.05|||||||ANCOVA||||
1602031|NCT02760654|2943327|Superiority||||||>|0.05|||||||ANCOVA||||
1602032|NCT02760654|2943328|Superiority||||||>|0.05|||||||ANCOVA||||
1602033|NCT02760654|2943329|Superiority||||||>|0.05|||||||ANCOVA||||
1602034|NCT02760654|2943330|Superiority||||||<|0.05|||||||ANCOVA||||
1602242|NCT02756689|2943622|Superiority|||||||0.29|||||||Wilcoxon (Mann-Whitney)||||
1602035|NCT02760264|2943371|Other|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."
1602036|NCT02760264|2943373|Other|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."
1602037|NCT02760264|2943375|Other|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."
1602038|NCT02760264|2943376|Other|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."
1602039|NCT02760264|2943378|Other|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."
1602040|NCT02760264|2943380|Other|Treatment levels were not compared.|||||||||||||||||"Safety Population was used for this analysis. Safety Population includes all subjects who receive at least one dose of vamorolone study medication.~Treatment levels were not compared."
1602041|NCT02759939|2943404|Superiority||Odds Ratio (OR)|0.8||||0.72|2-Sided|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms|||
1602042|NCT02759939|2943404|Superiority||Odds Ratio (OR)|0.95||||0.99|2-Sided|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms|||
1602043|NCT02759939|2943404|Superiority||Odds Ratio (OR)|1.47||||0.32|2-Sided|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms|||
1602044|NCT02759939|2943404|Superiority||Odds Ratio (OR)|1.23||||0.8|2-Sided|||||Adjusted for multiple comparisons using the Scheffe method|See below|Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms|||
1602045|NCT02758171|2943448|Superiority or Other||Adjusted geometric mean (gMean) ratio|98.15|Standard Deviation|15.2|||2-Sided|90.0|93.456|103.082|||||"The ratio [%] calculated as T [FDC (10 mg Empagliflozin and 5 mg Linagliptin)]/R [Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.|
1602046|NCT02758171|2943449|Superiority or Other||Adjusted geometric mean (gMean) ratio|101.44|Standard Deviation|5.7|||2-Sided|90.0|99.574|103.336|||||"The ratio [%] calculated as T [FDC (10 mg Empagliflozin and 5 mg Linagliptin)]/R [Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.|
1602047|NCT02758171|2943450|Non-Inferiority or Equivalence|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|107.51|Standard Deviation|27.4||0.0027|2-Sided|90.0|98.561|117.282|||ANOVA||"The ratio [%] calculated as T [FDC (10 mg Empagliflozin and 5 mg Linagliptin)]/R [Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.|
1602048|NCT02758171|2943451|Non-Inferiority or Equivalence|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|102.33|Standard Deviation|13.6|<|0.0001|2-Sided|90.0|97.945|106.91|||ANOVA||"The ratio [%] calculated as T [FDC (10 mg Empagliflozin and 5 mg Linagliptin)]/R [Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.|
1602049|NCT02758171|2943452|Non-Inferiority or Equivalence|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|99.39|Standard Deviation|13.1|<|0.0001|2-Sided|90.0|95.29|103.672|||ANOVA||"The ratio [%] calculated as T [FDC (10 mg Empagliflozin and 5 mg Linagliptin)]/R [Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.|
1602050|NCT02758171|2943453|Non-Inferiority or Equivalence|Bioequivalence acceptable range of 80.00% to 125.00%.|Adjusted geometric mean (gMean) ratio|101.71|Standard Deviation|5.8|<|0.0001|2-Sided|90.0|99.818|103.644|||ANOVA||"The ratio [%] calculated as T [FDC (10 mg Empagliflozin and 5 mg Linagliptin)]/R [Empagliflozin (10 mg) + Linagliptin (5 mg) Single Tablets].~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."|The statistical model used was an Analysis of Variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation: Sequence, subjects within sequences, period, and treatment. The effect subjects within sequences was considered as random, whereas the other effects were considered as fixed.|
1602053|NCT02757963|2943467|Other||Proportion|0.355|||||2-Sided|95.0|0.332|0.379|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS >=8 or BPE/BPO >=3|
1602054|NCT02757963|2943467|Other||Proportion|0.377|||||2-Sided|95.0|0.349|0.406|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS >=8 and BPE/BPO >=3|
1602055|NCT02757963|2943467|Other||Proportion|0.368|||||2-Sided|95.0|0.341|0.395|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm BPE/BPO >=3|
1602056|NCT02757963|2943467|Other||Proportion|0.362|||||2-Sided|95.0|0.337|0.386|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS >=8|
1602057|NCT02757963|2943468|Other||Proportion|0.9|||||2-Sided|95.0|0.87|0.925|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm PSS >=8 or BPE/BPO >=3|
1602058|NCT02757963|2943468|Other||Proportion|0.907|||||2-Sided|95.0|0.873|0.935|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS >=8 and BPE/BPO >=3|
1602059|NCT02757963|2943468|Other||Proportion|0.907|||||2-Sided|95.0|0.873|0.934|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm BPE/BPO >=3|
1602060|NCT02757963|2943468|Other||Proportion|0.9|||||2-Sided|95.0|0.87|0.926|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS >=8|
1602061|NCT02757963|2943469|Other||Proportion|0.873|||||2-Sided|95.0|0.843|0.9|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS >=8 or BPE/BPO >=3|
1602062|NCT02757963|2943469|Other||Proportion|0.889|||||2-Sided|95.0|0.854|0.917|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS >=8 and BPE/BPO >=3|
1602063|NCT02757963|2943469|Other||Proportion|0.877|||||2-Sided|95.0|0.846|0.904|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.|For Arm IPSS >=8|
1602064|NCT02757963|2943470|Other||Proportion|0.883|||||2-Sided|95.0|0.849|0.912|||||Proportion = Numerator / Denominator. 95% confidence interval on the proportion is calculated by using the exact (Clopper-Pearson) method.||
1602065|NCT02757950|2943474|Other|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|1.342||||0.0931|2-Sided|95.0|0.952|1.89||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.|
1602066|NCT02757950|2943475|Other|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.638||||0.0036|2-Sided|95.0|0.471|0.863||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.|
1602067|NCT02757950|2943476|Other|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.254||||0.0127|2-Sided|95.0|0.086|0.746||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.|
1602068|NCT02757950|2943477|Other|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.428||||0.0155|2-Sided|95.0|0.215|0.851||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.|
1602069|NCT02757950|2943478|Other|The comparison of the relative risk with its two sided 95% CI of each primary endpoint between the Exposed cohort and the Unexposed cohort was obtained by means of logistic regression model, using the exposure status as a binary independent variable in the model. Absence of increased relative risk was concluded if the respective 95% CI contained 1.|Incidence rate ratio|0.548||||0.1147|2-Sided|95.0|0.259|1.157||A multiple logistic regression model was fitted with a backward selection to identify the possible confounding factors for each of the primary safety event using an alpha level of 0.1.|Regression, Logistic|||The analysis contained only the subjects with vaccination date in the Exposed cohort and subjects from the Unexposed cohort.|
1602070|NCT02757768|2943479|Superiority||LS Mean of Difference|1.4|Standard Error of the Mean|2.1||0.493|2-Sided|95.0|-2.7|5.5|||ANCOVA|||EoT Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602180|NCT02757352|2943568|Superiority||LS Mean Difference|-4.2|Standard Error of the Mean|0.751|<|0.001|2-Sided|95.0|-5.68|-2.72|||ANCOVA||||
1602071|NCT02757768|2943479|Superiority||LS Mean of Difference|2.2|Standard Error of the Mean|2.1||0.297|2-Sided|95.0|-1.9|6.3|||ANCOVA|||Week 12 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602072|NCT02757768|2943479|Superiority||LS Mean of Difference|2.5|Standard Error of the Mean|1.9||0.19|2-Sided|95.0|-1.3|6.3|||ANCOVA|||Week 8 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602073|NCT02757768|2943479|Superiority||LS Mean of Difference|3.1|Standard Error of the Mean|1.9||0.107|2-Sided|95.0|-0.7|6.8|||ANCOVA|||Week 4 Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602074|NCT02757768|2943480|Superiority||LS Mean of Difference|0.03|Standard Error of the Mean|0.11||0.78|2-Sided|95.0|-0.18|0.24|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602075|NCT02757768|2943480|Superiority||LS Mean of Difference|0.0|Standard Error of the Mean|0.12||0.984|2-Sided|95.0|-0.22|0.23|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602076|NCT02757768|2943480|Superiority||LS Mean of Difference|0.07|Standard Error of the Mean|0.11||0.501|2-Sided|95.0|-0.14|0.28|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602077|NCT02757768|2943480|Superiority||LS Mean of Difference|0.13|Standard Error of the Mean|0.11||0.226|2-Sided|95.0|-0.08|0.34|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602078|NCT02757768|2943482|Superiority||LS Mean of Difference|-0.1|Standard Error of the Mean|0.1||0.525|2-Sided|95.0|-0.2|0.1|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602079|NCT02757768|2943482|Superiority||LS Mean of Difference|-0.1|Standard Error of the Mean|0.1||0.312|2-Sided|95.0|-0.3|0.1|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602080|NCT02757768|2943482|Superiority||LS Mean of Difference|0.0|Standard Error of the Mean|0.1||0.598|2-Sided|95.0|-0.2|0.1|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602081|NCT02757768|2943482|Superiority||LS Mean of Difference|-0.1|Standard Error of the Mean|0.1||0.223|2-Sided|95.0|-0.2|0.1|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602082|NCT02757768|2943483|Superiority|||||||0.5121|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||EoT Placebo vs. Mirabegron.|
1602083|NCT02757768|2943483|Superiority|||||||0.774|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 12 Placebo vs. Mirabegron.|
1602084|NCT02757768|2943483|Superiority|||||||0.4073|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 8 Placebo vs. Mirabegron.|
1602085|NCT02757768|2943483|Superiority|||||||0.4591|||||||t-test, 2 sided|Statistical comparisons were be made using 2-sided tests at α = 0.05 significance level.||Week 4 Placebo vs. Mirabegron.|
1602086|NCT02757768|2943484|Superiority||LS Mean of Difference|-0.71|Standard Error of the Mean|1.1||0.516|2-Sided|95.0|-2.86|1.44|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602087|NCT02757768|2943484|Superiority||LS Mean of Difference|-0.08|Standard Error of the Mean|1.12||0.94|2-Sided|95.0|-2.28|2.11|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602088|NCT02757768|2943484|Superiority||LS Mean of Difference|-0.32|Standard Error of the Mean|1.12||0.773|2-Sided|95.0|-2.52|1.87|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602089|NCT02757768|2943484|Superiority||LS Mean of Difference|-1.1|Standard Error of the Mean|1.05||0.293|2-Sided|95.0|-3.16|0.95|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602181|NCT02757352|2943568|Superiority||LS Mean Difference|-3.07|Standard Error of the Mean|0.764|<|0.001|2-Sided|95.0|-4.58|-1.57|||ANCOVA||||
1602182|NCT02757352|2943569|Superiority||LS Mean Difference|-1.29|Standard Error of the Mean|0.404||0.002|2-Sided|95.0|-2.08|-0.49|||Mixed Models Analysis||||
1602090|NCT02757768|2943485|Superiority||LS Mean of Difference|0.25|Standard Error of the Mean|1.6||0.876|2-Sided|95.0|-2.89|3.38|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602091|NCT02757768|2943485|Superiority||LS Mean of Difference|1.53|Standard Error of the Mean|1.63||0.348|2-Sided|95.0|-1.67|4.73|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602092|NCT02757768|2943485|Superiority||LS Mean of Difference|0.92|Standard Error of the Mean|1.55||0.554|2-Sided|95.0|-2.12|3.96|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602093|NCT02757768|2943485|Superiority||LS Mean of Difference|-0.02|Standard Error of the Mean|1.49||0.99|2-Sided|95.0|-2.94|2.91|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602094|NCT02757768|2943486|Superiority||LS Mean of Difference|0.14|Standard Error of the Mean|1.39||0.919|2-Sided|95.0|-2.6|2.88|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602095|NCT02757768|2943486|Superiority||LS Mean of Difference|1.17|Standard Error of the Mean|1.42||0.408|2-Sided|95.0|-1.61|3.95|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602096|NCT02757768|2943486|Superiority||LS Mean of Difference|0.35|Standard Error of the Mean|1.38||0.798|2-Sided|95.0|-2.36|3.07|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602097|NCT02757768|2943486|Superiority||LS Mean of Difference|-1.82|Standard Error of the Mean|1.29||0.161|2-Sided|95.0|-4.35|0.72|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602098|NCT02757768|2943487|Superiority||LS Mean of Difference|0.03|Standard Error of the Mean|1.51||0.985|2-Sided|95.0|-2.94|3.0|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602099|NCT02757768|2943487|Superiority||LS Mean of Difference|0.9|Standard Error of the Mean|1.54||0.559|2-Sided|95.0|-2.12|3.92|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602100|NCT02757768|2943487|Superiority||LS Mean of Difference|0.76|Standard Error of the Mean|1.41||0.592|2-Sided|95.0|-2.02|3.54|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602101|NCT02757768|2943487|Superiority||LS Mean of Difference|-1.89|Standard Error of the Mean|1.36||0.165|2-Sided|95.0|-4.56|0.78|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602102|NCT02757768|2943488|Superiority||LS Mean of Difference|-0.05|Standard Error of the Mean|1.26||0.968|2-Sided|95.0|-2.52|2.42|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602103|NCT02757768|2943488|Superiority||LS Mean of Difference|0.89|Standard Error of the Mean|1.28||0.486|2-Sided|95.0|-1.62|3.4|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602104|NCT02757768|2943488|Superiority||LS Mean of Difference|0.46|Standard Error of the Mean|1.2||0.698|2-Sided|95.0|-1.89|2.82|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602105|NCT02757768|2943488|Superiority||LS Mean of Difference|-1.35|Standard Error of the Mean|1.13||0.233|2-Sided|95.0|-3.57|0.87|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602106|NCT02757768|2943489|Superiority||LS Mean of Difference|-2.11|Standard Error of the Mean|1.48||0.154|2-Sided|95.0|-5.02|0.8|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602183|NCT02757352|2943569|Superiority||LS Mean Difference|-1.13|Standard Error of the Mean|0.404||0.006|2-Sided|95.0|-1.92|-0.33|||Mixed Models Analysis||||
1602184|NCT02757352|2943570|Superiority||LS Mean Difference|-1.01|Standard Error of the Mean|0.305||0.001|2-Sided|95.0|-1.61|-0.41|||Mixed Models Analysis||||
1602107|NCT02757768|2943489|Superiority||LS Mean of Difference|-2.9|Standard Error of the Mean|1.51||0.055|2-Sided|95.0|-5.86|0.06|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602108|NCT02757768|2943489|Superiority||LS Mean of Difference|-3.84|Standard Error of the Mean|1.41||0.006|2-Sided|95.0|-6.6|-1.08|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602109|NCT02757768|2943489|Superiority||LS Mean of Difference|-1.75|Standard Error of the Mean|1.3||0.179|2-Sided|95.0|-4.29|0.8|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602110|NCT02757768|2943490|Superiority||LS Mean of Difference|-0.33|Standard Error of the Mean|0.3||0.272|2-Sided|95.0|-0.92|0.26|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602111|NCT02757768|2943490|Superiority||LS Mean of Difference|-0.28|Standard Error of the Mean|0.31||0.372|2-Sided|95.0|-0.89|0.34|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602112|NCT02757768|2943490|Superiority||LS Mean of Difference|-0.09|Standard Error of the Mean|0.32||0.767|2-Sided|95.0|-0.72|0.53|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602113|NCT02757768|2943490|Superiority||LS Mean of Difference|-0.11|Standard Error of the Mean|0.25||0.66|2-Sided|95.0|-0.61|0.39|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602114|NCT02757768|2943491|Superiority||LS Mean of Difference|-0.2|Standard Error of the Mean|0.1||0.148|2-Sided|95.0|-0.4|0.1|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602115|NCT02757768|2943491|Superiority||LS Mean of Difference|-0.2|Standard Error of the Mean|0.1||0.079|2-Sided|95.0|-0.4|0.0|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602116|NCT02757768|2943491|Superiority||LS Mean of Difference|-0.2|Standard Error of the Mean|0.1||0.054|2-Sided|95.0|-0.4|0.0|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602117|NCT02757768|2943491|Superiority||LS Mean of Difference|-0.1|Standard Error of the Mean|0.1||0.128|2-Sided|95.0|-0.3|0.0|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602118|NCT02757768|2943492|Superiority||LS Mean of Difference|-0.2|Standard Error of the Mean|0.2||0.288|2-Sided|95.0|-0.7|0.2|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602119|NCT02757768|2943492|Superiority||LS Mean of Difference|-0.3|Standard Error of the Mean|0.2||0.141|2-Sided|95.0|-0.8|0.1|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602120|NCT02757768|2943492|Superiority||LS Mean of Difference|-0.2|Standard Error of the Mean|0.2||0.43|2-Sided|95.0|-0.6|0.2|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602121|NCT02757768|2943492|Superiority||LS Mean of Difference|-0.3|Standard Error of the Mean|0.2||0.175|2-Sided|95.0|-0.7|0.1|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602122|NCT02757768|2943493|Superiority||LS Mean of Difference|0.1|Standard Error of the Mean|0.3||0.679|2-Sided|95.0|-0.4|0.7|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602123|NCT02757768|2943493|Superiority||LS Mean of Difference|-0.1|Standard Error of the Mean|0.3||0.843|2-Sided|95.0|-0.6|0.5|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602124|NCT02757768|2943493|Superiority||LS Mean of Difference|0.3|Standard Error of the Mean|0.3||0.241|2-Sided|95.0|-0.2|0.8|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602125|NCT02757768|2943493|Superiority||LS Mean of Difference|0.4|Standard Error of the Mean|0.3||0.121|2-Sided|95.0|-0.1|0.9|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602126|NCT02757768|2943494|Superiority||LS Mean of Difference|-0.1|Standard Error of the Mean|0.4||0.812|2-Sided|95.0|-1.0|0.8|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602127|NCT02757768|2943494|Superiority||LS Mean of Difference|-0.4|Standard Error of the Mean|0.5||0.4|2-Sided|95.0|-1.3|0.5|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602128|NCT02757768|2943494|Superiority||LS Mean of Difference|0.2|Standard Error of the Mean|0.4||0.7|2-Sided|95.0|-0.7|1.0|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602129|NCT02757768|2943494|Superiority||LS Mean of Difference|0.1|Standard Error of the Mean|0.4||0.723|2-Sided|95.0|-0.6|0.9|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602130|NCT02757768|2943495|Superiority||LS Mean of Difference|-0.67|Standard Error of the Mean|0.23||0.004|2-Sided|95.0|-1.13|-0.21|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602131|NCT02757768|2943495|Superiority||LS Mean of Difference|-0.65|Standard Error of the Mean|0.24||0.008|2-Sided|95.0|-1.13|-0.17|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602132|NCT02757768|2943495|Superiority||LS Mean of Difference|-0.71|Standard Error of the Mean|0.24||0.003|2-Sided|95.0|-1.18|-0.24|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602133|NCT02757768|2943495|Superiority||LS Mean of Difference|-0.26|Standard Error of the Mean|0.21||0.222|2-Sided|95.0|-0.68|0.16|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602134|NCT02757768|2943496|Superiority||LS Mean of Difference|-0.3|Standard Error of the Mean|0.31||0.64|2-Sided|95.0|-0.9|0.3|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602135|NCT02757768|2943496|Superiority||LS Mean of Difference|-0.25|Standard Error of the Mean|0.32||0.672|2-Sided|95.0|-0.87|0.38|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602136|NCT02757768|2943496|Superiority||LS Mean of Difference|-0.09|Standard Error of the Mean|0.32||0.393|2-Sided|95.0|-0.72|0.54|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602137|NCT02757768|2943496|Superiority||LS Mean of Difference|-0.12|Standard Error of the Mean|0.26||0.747|2-Sided|95.0|-0.63|0.38|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602138|NCT02757768|2943497|Superiority||LS Mean of Difference|9.25|Standard Error of the Mean|3.43||0.007|2-Sided|95.0|2.53|15.98|||ANCOVA|||EoT Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602139|NCT02757768|2943497|Superiority||LS Mean of Difference|8.99|Standard Error of the Mean|3.58||0.012|2-Sided|95.0|1.97|16.01|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602140|NCT02757768|2943497|Superiority||LS Mean of Difference|6.29|Standard Error of the Mean|3.28||0.056|2-Sided|95.0|-0.15|12.73|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602141|NCT02757768|2943497|Superiority||LS Mean of Difference|3.87|Standard Error of the Mean|2.8||0.167|2-Sided|95.0|-1.63|9.37|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602142|NCT02757768|2943498|Superiority||LS Mean of Difference|-0.39|Standard Error of the Mean|0.19||0.041|2-Sided|95.0|-0.76|-0.02|||ANCOVA|||Week 12 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602143|NCT02757768|2943498|Superiority||LS Mean of Difference|-0.52|Standard Error of the Mean|0.19||0.007|2-Sided|95.0|-0.89|-0.14|||ANCOVA|||Week 8 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602144|NCT02757768|2943498|Superiority||LS Mean of Difference|-0.11|Standard Error of the Mean|0.18||0.558|2-Sided|95.0|-0.46|0.25|||ANCOVA|||Week 4 Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602145|NCT02757768|2943499|Superiority||Least Squares (LS) Mean of Difference|-0.39|Standard Error of the Mean|0.19||0.039|2-Sided|95.0|-0.76|-0.02|||ANCOVA|||Placebo vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, age group (<65, >=65 years) and geographical region as fixed factors and baseline value as a covariate.|
1602146|NCT02757352|2943554|Superiority||LS Mean Difference|-9.99|Standard Error of the Mean|3.621||0.006|2-Sided|95.0|-17.12|-2.86|||ANCOVA|||Percentage of Impairment in Activities Performed Outside of Work|
1602147|NCT02757352|2943554|Superiority||LS Mean Difference|-10.63|Standard Error of the Mean|3.669||0.004|2-Sided|95.0|-17.85|-3.41|||LS Mean Difference|||Percentage of Impairment in Activities Performed Outside of Work|
1602148|NCT02757352|2943554|Superiority||LS Mean Difference|-6.21|Standard Error of the Mean|4.446||0.164|2-Sided|95.0|-15.0|2.58|||ANCOVA|||Percentage of presentism|
1602149|NCT02757352|2943554|Superiority||LS Mean Difference|-13.61|Standard Error of the Mean|4.558||0.003|2-Sided|95.0|-22.62|-4.6|||ANCOVA|||Percentage of presentism|
1602150|NCT02757352|2943554|Superiority||LS Mean Difference|-4.15|Standard Error of the Mean|3.098||0.182|2-Sided|95.0|-10.27|1.97|||ANCOVA|||Percentage of absenteeism|
1602151|NCT02757352|2943554|Superiority||LS Mean Difference|-5.9|Standard Error of the Mean|3.114||0.06|2-Sided|95.0|-12.05|0.26|||ANCOVA|||Percentage of absenteeism|
1602152|NCT02757352|2943554|Superiority||LS Mean Difference|-6.29|Standard Error of the Mean|4.697||0.183|2-Sided|95.0|-15.58|3.0|||ANCOVA|||Overall Impairment Score|
1602153|NCT02757352|2943554|Superiority||LS Mean Difference|-13.76|Standard Error of the Mean|4.835||0.005|2-Sided|95.0|-23.32|-4.2|||ANCOVA|||Overall Impairment Score|
1602154|NCT02757352|2943555|Superiority||LS Mean Difference|-0.7|Standard Error of the Mean|0.82||0.386|2-Sided|95.0|-2.3|0.9|||Mixed Models Analysis||||
1602155|NCT02757352|2943555|Superiority||LS Mean Difference|-0.8|Standard Error of the Mean|0.81||0.348|2-Sided|95.0|-2.4|0.8|||Mixed Models Analysis||||
1602156|NCT02757352|2943556|Superiority||LS Mean Difference|-0.97|Standard Error of the Mean|0.602||0.11|2-Sided|95.0|-2.15|0.22|||Mixed Models Analysis||||
1602157|NCT02757352|2943556|Superiority||LS Mean Difference|-0.59|Standard Error of the Mean|0.601||0.33|2-Sided|95.0|-1.77|0.6|||Mixed Models Analysis||||
1602158|NCT02757352|2943557|Superiority||LS Mean Difference|-0.6|Standard Error of the Mean|0.5||0.206|2-Sided|95.0|-1.6|0.4|||Mixed Models Analysis||||
1602159|NCT02757352|2943557|Superiority||LS Mean Difference|-0.5|Standard Error of the Mean|0.5||0.325|2-Sided|95.0|-1.5|0.5|||Mixed Models Analysis||||
1602160|NCT02757352|2943559|Superiority||LS Mean Difference|-0.76|Standard Error of the Mean|0.348||0.034|2-Sided|95.0|-1.46|-0.06|||Mixed Models Analysis|||SJC|
1602161|NCT02757352|2943559|Superiority||LS Mean Difference|-0.97|Standard Error of the Mean|0.355||0.009|2-Sided|95.0|-1.68|-0.26|||Mixed Models Analysis|||SJC|
1602162|NCT02757352|2943559|Superiority||LS Mean Difference|-3.53|Standard Error of the Mean|1.388||0.013|2-Sided|95.0|-6.3|-0.76|||Mixed Models Analysis|||TJC|
1602163|NCT02757352|2943559|Superiority||LS Mean Difference|-1.79|Standard Error of the Mean|1.442||0.219|2-Sided|95.0|-4.66|1.09|||Mixed Models Analysis|||TJC|
1602164|NCT02757352|2943560|Superiority||LS Mean Difference|-0.85|Standard Error of the Mean|0.493||0.088|2-Sided|95.0|-1.82|0.13|||Mixed Models Analysis||||
1602165|NCT02757352|2943560|Superiority||LS Mean Difference|-0.87|Standard Error of the Mean|0.496||0.082|2-Sided|95.0|-1.85|0.11|||Mixed Models Analysis||||
1602166|NCT02757352|2943561|Superiority||LS Mean Difference|-0.77|Standard Error of the Mean|0.402||0.057|2-Sided|95.0|-1.56|0.02|||Mixed Models Analysis||||
1602167|NCT02757352|2943561|Superiority||LS Mean Difference|-0.46|Standard Error of the Mean|0.406||0.257|2-Sided|95.0|-1.26|0.34|||Mixed Models Analysis||||
1602168|NCT02757352|2943562|Superiority||LS Mean Difference|0.34|Standard Error of the Mean|0.327||0.295|2-Sided|95.0|-0.3|0.99|||Mixed Models Analysis||||
1602169|NCT02757352|2943562|Superiority||LS Mean Difference|0.05|Standard Error of the Mean|0.325||0.871|2-Sided|95.0|-0.59|0.7|||Mixed Models Analysis||||
1602170|NCT02757352|2943563|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|0.148||0.038|2-Sided|95.0|-0.6|-0.02|||Mixed Models Analysis||||
1602171|NCT02757352|2943563|Superiority||LS Mean Difference|-0.4|Standard Error of the Mean|0.148||0.008|2-Sided|95.0|-0.69|-0.1|||Mixed Models Analysis||||
1602172|NCT02757352|2943564|Superiority||LS Mean Difference|-2.743|Standard Error of the Mean|2.8202||0.331|2-Sided|95.0|-8.294|2.807|||Mixed Models Analysis||||
1602173|NCT02757352|2943564|Superiority||LS Mean Difference|-3.807|Standard Error of the Mean|2.8507||0.183|2-Sided|95.0|-9.418|1.804|||Mixed Models Analysis||||
1602174|NCT02757352|2943565|Superiority||Odds Ratio (OR)|4.22||||0.031|2-Sided|95.0|1.14|15.66|||Regression, Logistic||||
1602175|NCT02757352|2943565|Superiority||Odds Ratio (OR)|5.33||||0.0011|2-Sided|96.0|1.47|19.4|||Regression, Logistic||||
1602176|NCT02757352|2943566|Superiority||LS Mean Difference|-1.18|Standard Error of the Mean|0.442||0.008|2-Sided|95.0|-2.05|-0.31|||Mixed Models Analysis||||
1602177|NCT02757352|2943566|Superiority||LS Mean Difference|-1.06|Standard Error of the Mean|0.443||0.018|2-Sided|95.0|-1.93|-0.18|||Mixed Models Analysis||||
1602178|NCT02757352|2943567|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.608||0.648|2-Sided|95.0|-1.48|0.93|||Mixed Models Analysis||||
1602179|NCT02757352|2943567|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.621||0.849|2-Sided|95.0|-1.35|1.11|||Mixed Models Analysis||||
1602185|NCT02757352|2943570|Superiority||LS Means Square Difference|-0.67|Standard Error of the Mean|0.308||0.031|2-Sided|95.0|-1.28|-0.06|||Mixed Models Analysis||||
1602186|NCT02757352|2943571|Superiority||Odds Ratio (OR)|3.99|||<|0.001|2-Sided|95.0|1.76|9.05|||Regression, Logistic||||
1602187|NCT02757352|2943571|Superiority||Odds Ratio (OR)|4.58|||<|0.001|2-Sided|95.0|2.02|10.41|||Regression, Logistic||||
1602188|NCT02757352|2943572|Superiority||Odds Ratio (OR)|3.43|||<|0.001|2-Sided|95.0|1.66|7.08|||Regression, Logistic||||
1602189|NCT02757352|2943572|Superiority||Odds Ratio (OR)|2.73|||<|0.008|2-Sided|95.0|1.3|5.76|||Regression, Logistic||||
1602190|NCT02757352|2943573|Superiority||LS Mean Difference|4.6081|Standard Error of the Mean|1.6455||0.006|2-Sided|95.0|1.3629|7.8533|||Mixed Models Analysis||||
1602191|NCT02757352|2943573|Superiority||LS Mean Difference|4.2001|Standard Error of the Mean|1.6467||0.012|2-Sided|95.0|0.9525|7.4477|||Mixed Models Analysis||||
1602192|NCT02757352|2943574|Superiority||LS Mean Difference|2.7497|Standard Error of the Mean|1.1278||0.015|2-Sided|95.0|0.5299|4.9694|||Mixed Models Analysis||||
1602193|NCT02757352|2943574|Superiority||LS Mean Difference|2.8509|Standard Error of the Mean|1.139||0.013|2-Sided|95.0|0.6092|5.0926|||Mixed Models Analysis||||
1602194|NCT02757352|2943576|Superiority||LS Mean Difference|-0.69|Standard Error of the Mean|0.178|<|0.001|2-Sided|95.0|-1.05|-0.34|||Mixed Models Analysis||||
1602195|NCT02757352|2943576|Superiority||LS Mean Difference|-0.61|Standard Error of the Mean|0.179|<|0.001|2-Sided|95.0|-0.96|-0.26|||Mixed Models Analysis||||
1602196|NCT02757352|2943577|Superiority||LS Mean Difference|-0.68|Standard Error of the Mean|0.134|<|0.001|2-Sided|95.0|-0.94|-0.41|||Mixed Models Analysis||||
1602197|NCT02757352|2943577|Superiority||LS Mean Difference|-0.54|Standard Error of the Mean|0.136|<|0.001|2-Sided|95.0|-0.81|-0.28|||Mixed Models Analysis||||
1602198|NCT02757352|2943578|Superiority||Odds Ratio (OR)|2.85||||0.004|2-Sided|95.0|1.4|5.77|||Regression, Logistic||||
1602199|NCT02757352|2943578|Superiority||Odds Ratio (OR)|2.82||||0.004|2-Sided|95.0|1.38|5.77|||Regression, Logistic||||
1602200|NCT02757352|2943579|Superiority||Odds Ratio (OR)|2.78||||0.002|2-Sided|95.0|1.48|5.25|||Regression, Logistic||||
1602201|NCT02757352|2943579|Superiority||Odds Ratio (OR)|2.36||||0.009|2-Sided|95.0|1.23|4.51|||Regression, Logistic||||
1602202|NCT02757105|2943580|Superiority||Mean Difference (Final Values)|14.5||||0.135|2-Sided|95.0|-3.4|32.5|||Chi-squared, Corrected||||
1602203|NCT02757105|2943581|Superiority||Mean Difference (Final Values)|11.5||||0.278|2-Sided|95.0|-7.7|30.6|||Chi-squared, Corrected||||
1602204|NCT02757105|2943582|Superiority|||||||0.919|||||||Chi-squared, Corrected||||
1602205|NCT02757105|2943583|Superiority|||||||0.009|||||||Chi-squared, Corrected||||
1602206|NCT02757105|2943584|Superiority|||||||0.042|||||||Chi-squared, Corrected||||
1602207|NCT02757105|2943585|Superiority|||||||0.081|||||||Chi-squared, Corrected||||
1602208|NCT02757105|2943586|Superiority|||||||0.41|||||||Chi-squared, Corrected||||
1602209|NCT02757105|2943587|Superiority|||||||0.036|||||||Chi-squared, Corrected||||
1602210|NCT02756819|2943606|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Metabolic syndrome)|Wilcoxon test||||
1602211|NCT02756819|2943606|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Neither diabetes mellitus nor metabolic syndrome)|Wilcoxon test||||
1602212|NCT02756819|2943606|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - Yes)|Wilcoxon test||||
1602213|NCT02756819|2943606|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - No)|Wilcoxon test||||
1602214|NCT02756819|2943606|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Impaired glucose tolerance)|Wilcoxon test||||
1602215|NCT02756819|2943606|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Normal glucose metabolism)|Wilcoxon test||||
1602216|NCT02756819|2943606|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class III)|Wilcoxon test||||
1602217|NCT02756819|2943606|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class II)|Wilcoxon test||||
1602218|NCT02756819|2943606|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class I)|Wilcoxon test||||
1602219|NCT02756819|2943606|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Overweight)|Wilcoxon test||||
1602220|NCT02756819|2943607|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Metabolic syndrome)|Wilcoxon test||||
1602221|NCT02756819|2943607|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Neither diabetes mellitus nor metabolic syndrome)|Wilcoxon test||||
1602222|NCT02756819|2943607|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - Yes)|Wilcoxon test||||
1602223|NCT02756819|2943607|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Diabetes Mellitus - No)|Wilcoxon test||||
1602224|NCT02756819|2943607|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Impaired glucose tolerance)|Wilcoxon test||||
1602225|NCT02756819|2943607|Other||||||<|0.001|||||||Wilcoxon test|P-value was reported for Change from baseline at Month 6 (Normal glucose metabolism)|||
1602226|NCT02756819|2943607|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class III)|Wilcoxon test||||
1602227|NCT02756819|2943607|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class II)|Wilcoxon test||||
1602228|NCT02756819|2943607|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Obesity class I)|Wilcoxon test||||
1602229|NCT02756819|2943607|Other||||||<|0.001||||||P-value was reported for Change from baseline at Month 6 (Overweight)|Wilcoxon test||||
1602230|NCT02756819|2943610|Other||||||<|0.001||||||P-value was reported for Change at Month 6 relative to Baseline.|Wilcoxon test||||
1602231|NCT02756819|2943611|Other||||||<|0.001||||||P-value was reported for Change at Month 6 relative to Baseline.|Wilcoxon test||||
1602232|NCT02756689|2943612|Superiority|||||||0.6|||||||Wilcoxon (Mann-Whitney)||||
1602243|NCT02756689|2943623|Superiority|||||||0.75|||||||Wilcoxon (Mann-Whitney)||||
1602244|NCT02756689|2943624|Superiority|||||||0.75|||||||Wilcoxon (Mann-Whitney)||||
1602245|NCT02756689|2943625|Superiority|||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1602246|NCT02756689|2943626|Superiority|||||||0.77|||||||Wilcoxon (Mann-Whitney)||||
1602247|NCT02756689|2943627|Superiority|||||||0.68|||||||Wilcoxon (Mann-Whitney)||||
1602248|NCT02756689|2943628|Superiority|||||||0.234|||||||Wilcoxon (Mann-Whitney)||||
1602249|NCT02756689|2943629|Superiority||Risk Ratio (RR)|1.0|||>|0.99|2-Sided|95.0|0.3|3.2|||Chi-squared||||
1602250|NCT02756689|2943630|Superiority||Risk Ratio (RR)|0.5||||0.62|2-Sided|95.0|0.05|5.3|||Chi-squared||||
1602251|NCT02756689|2943631|Superiority||||||>|0.99|||||||Chi-squared||||
1602252|NCT02756689|2943632|Superiority||Risk Ratio (RR)|0.3||||0.37|2-Sided|95.0|0.03|2.3|||Chi-squared||||
1602253|NCT02756689|2943633|Superiority|||||||0.5|||||||Chi-squared||||
1602254|NCT02756689|2943634|Superiority||||||>|0.99|||||||Chi-squared||||
1602255|NCT02756689|2943635|Superiority||Risk Ratio (RR)|1.0|||>|0.99|2-Sided|95.0|0.1|15.4|||Chi-squared||||
1602256|NCT02756689|2943636|Superiority|||||||0.5|||||||Chi-squared||||
1602257|NCT02756689|2943637|Superiority||Risk Ratio (RR)|0.8||||0.73|2-Sided|95.0|0.3|2.6|||Chi-squared||||
1602258|NCT02756689|2943638|Superiority||Risk Ratio (RR)|0.7||||0.68|2-Sided|95.0|0.1|3.8|||Chi-squared||||
1602259|NCT02756689|2943639|Superiority||Risk Ratio (RR)|0.3||||0.09|2-Sided|95.0|0.1|1.3|||Chi-squared||||
1602260|NCT02756689|2943640|Superiority||Risk Ratio (RR)|0.7||||0.43|2-Sided|95.0|0.3|1.7|||Chi-squared||||
1602261|NCT02756689|2943641|Superiority||Risk Ratio (RR)|1.0|||>|0.99|2-Sided|95.0|0.2|4.7|||Chi-squared||||
1602262|NCT02756689|2943642|Superiority|||||||0.06|||||||t-test, 2 sided||||
1602263|NCT02756689|2943643|Superiority|||||||0.42|||||||t-test, 2 sided||||
1602264|NCT02756689|2943644|Superiority|||||||0.38|||||||t-test, 2 sided||||
1602265|NCT02756689|2943645|Superiority|||||||0.82|||||||t-test, 2 sided||||
1602266|NCT02756689|2943646|Superiority|||||||1|||||||Chi-squared||||
1602267|NCT02756689|2943647|Superiority||Risk Ratio (RR)|0.8||||0.74|2-Sided|95.0|0.2|2.8|||Chi-squared||||
1602268|NCT02756689|2943648|Superiority||Risk Ratio (RR)|3.3||||0.06|2-Sided|95.0|0.9|11.4|||Chi-squared||||
1602269|NCT02756689|2943649|Superiority|||||||0.12|||||||Chi-squared||||
1602270|NCT02756689|2943650|Superiority||Risk Ratio (RR)|2.1||||0.09|2-Sided|95.0|0.8|5.3|||Chi-squared||||
1602271|NCT02756689|2943651|Superiority|||||||0.29|||||||t-test, 2 sided||||
1602272|NCT02756689|2943652|Superiority|||||||0.38|||||||t-test, 2 sided||||
1602273|NCT02756637|2943653|Other||Hazard Ratio (HR)|1.01|||||2-Sided|95.0|0.9|1.14||||||The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.|
1602274|NCT02756637|2943653|Other||Hazard Ratio (HR)|1.04|||||2-Sided|95.0|0.98|1.11||||||The Hazard Ration is the ratio of survival rates between patients with high NLR and low NLR.|
1602275|NCT02756611|2943668|Superiority||||||<|0.001|||||||Binomial test|||The null hypothesis stated that the CR rate for BCRi-naïve participants would be ≤ 6%, based on the CR rate reported for current therapies at the time the study was designed, with an alternative hypothesis that the CR rate would be > 6%. If the p-value for this test was < 0.025, the null hypothesis would be rejected.|
1602276|NCT02756078|2943683|Non-Inferiority|A non-inferiority margin of 0.67 was used.|Posterior odds ratio|1.35|Standard Deviation|0.203|||2-Sided|95.0|0.99|1.79|||||Odds ratio was calculated as senofilcon A over samfilcon A.||
1602277|NCT02756078|2943684|Non-Inferiority|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.05|Standard Deviation|0.159|||2-Sided|95.0|-0.36|0.26|||||Mean difference was calculated as senofilcon A minus samfilcon A.||
1602278|NCT02756078|2943685|Non-Inferiority|A non-inferiority margin of -2 hour was used.|Posterior mean difference|0.05|Standard Deviation|0.261|||2-Sided|95.0|-0.47|0.57|||||Mean difference was calculated as senofilcon A minus samfilcon A||
1602279|NCT02756078|2943686|Non-Inferiority|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.06|Standard Deviation|0.107|||2-Sided|95.0|-0.27|0.16|||||Mean difference was calculated as senofilcon A minus samfilcon A||
1602280|NCT02756078|2943687|Non-Inferiority|A non-inferiority margin of -2 hour was used.|Posterior mean difference|-0.37|Standard Deviation|0.313|||2-Sided|95.0|-1.0|0.25|||||||Mean difference was calculated as senofilcon A minus samfilcon A.
1602281|NCT02756078|2943688|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Posterior Mean Difference|13.7|Standard Deviation|1.701|||2-Sided|95.0|10.34|17.05|||||Mean difference was calculated as Test (senofilcon A) minus Control (samfilcon A)||
1602282|NCT02756078|2943689|Non-Inferiority|A non-inferiority margin of -5 points was used. This margin is based on a 10% shift in the distribution of CLUE score.|Posterior Mean Difference|5.0|Standard Deviation|1.796|||2-Sided|98.0|1.3|8.73|||||Mean difference was calculated as Test (senofilcon A) minus Control (samfilcon A)||
1602283|NCT02755831|2943692|Superiority||||||<|0.05|||||||t-test, 2 sided|T-test used to compare mean difference in hospital costs at time of delivery.|||
1602284|NCT02755831|2943693|Other||||||<|0.05|||||||Friedman Test|Friedman’s test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences in treatment group only.|||
1602285|NCT02755831|2943694|Other||||||<|0.05|||||||Friedman|Friedman’s test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences at individual time points.|||
1602286|NCT02755831|2943695|Other||||||<|0.05|||||||Friedman test|Friedman’s test was used to analyze differences with a post hoc Wilcoxon Ranked Sign test to compare differences at individual time points.|||
1602287|NCT02755831|2943696|Superiority||||||<|0.05|||||||Fisher Exact|||Fisher's Exact Test|
1602410|NCT02751931|2943900|Other||Mean Difference (Net)|0.64||||0.007|2-Sided|95.0|0.19|1.08||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents|
1602288|NCT02755805|2943704|Superiority or Other||Cohen's d effect size at month 6|0.7||||0.04|2-Sided|||||a priori threshold set at <0.05|repeated measures fixed effects model|F(2,28)=3.61|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.|
1602289|NCT02755805|2943705|Superiority or Other||Cohen's d effect size at month 6|1.23||||0.002|2-Sided|||||a priori threshold set at p<0.05|Mixed Models Analysis|F(2,34)=7.83|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to assigned intervention group regardless of study completion.|
1602290|NCT02755805|2943706|Superiority or Other||Cohen's d effect size at month 6|0.76||||0.09|2-Sided|||||a priori threshold set at p<0.05|Mixed Models Analysis|F(2,34)=2.55|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.|
1602291|NCT02755805|2943707|Superiority or Other||Cohen's d effect size at month 6|1.11||||0.007|2-Sided|||||a priori threshold set at p<0.05|Mixed Models Analysis|"F(3,74)=4.37~P-values were calculated using mixed model analyses and controlled for stoke severity as a covariate."|Effect size was calculated using mean change scores (baseline to month 6) and standard error of change (baseline to month 6) for each group.|All analyses were performed using the intent-to-treat principle so that comparisons were made according to the assigned intervention group regardless of study completion.|
1602292|NCT02755129|2943709|Other||||||||||||||||||"To assess the similarity between the Reveal LINQ measures and those from the reference system, correlation coefficients were used.~The correlation coefficient was calculated over windows of 4 seconds and averaged for each exercise. Then, the average correlation coefficient over all patients and exercise was calculated."
1602293|NCT02754674|2943712|Superiority|||||||0.054|||||||t-test, 2 sided||||
1602294|NCT02754674|2943713|Superiority||||||>|0.05|||||||t-test, 2 sided||||
1602295|NCT02754674|2943714|Superiority|Student’s t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. The statistical significance level was set at .05.|||||>|0.05|||||||t-test, 2 sided|||We used the Kolmogorov-Smirnov test to assess the normality of the data distribution. Student’s t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. Pearson’s Chi-square test or Fisher’s exact test was used to analyze categorical variables between groups. The statistical significance level was set at .05.|
1602296|NCT02754674|2943715|Superiority||||||>|0.05|||||||Chi-squared||||
1602297|NCT02754674|2943716|Superiority|||||||0.008|||||||t-test, 2 sided||||
1602298|NCT02754661|2943717|Non-Inferiority|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.0607||||0.0034|2-Sided|90.0|-0.0371|0.1585|||Farrington-Manning test||Based on Farrington-Manning Method||
1602299|NCT02754661|2943718|Non-Inferiority|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.0023||||0.093|2-Sided|90.0|-0.1249|0.1249|||Farrington-Manning test||Based on Farrington-Manning Method||
1602300|NCT02754661|2943719|Non-Inferiority|Non-inferiority margin was set as 10%|Risk Difference (RD)|-0.026||||0.019|2-Sided|90.0|-0.0847|0.0327|||Farrington-Manning test||Based on Farrington-Manning Method||
1602301|NCT02754661|2943720|Non-Inferiority|Non-inferiority margin was set as 10%|Risk Difference (RD)|0.3732|||<|0.0001|2-Sided|90.0|0.203|0.5434|||Farrington-Manning test||Based on Farrington-Manning Method||
1602302|NCT02754661|2943721|Non-Inferiority|The non-inferiority margin (δ) is pre-defined to be 5% in this study. Posterior Probability was based on Bayesian analysis.|Posterior Probability Bayesian analysis|0.9999|||||2-Sided||||||||Support the claim of statistical non-inferiority of CCE vs CTC||
1602303|NCT02754492|2943724|Other|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|Standard Error of the Mean|0.0|||1-Sided|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|
1602304|NCT02754492|2943724|Other|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|Standard Error of the Mean|0.0|||1-Sided|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|
1602305|NCT02754492|2943724|Other|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|0.989|Standard Error of the Mean|0.0107|||1-Sided|95.0|0.95|||||||Up to 350 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|
1602315|NCT02753075|2943762|Superiority or Other||LS mean difference|0.11||||0.7525|2-Sided|95.0|-0.578|0.798|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1602550|NCT02750410|2944074|Superiority||LS mean difference|-41.45|||<|0.001|2-Sided|95.0|-58.81|-24.09|||t-test, 2 sided|||Bedtime BG|
1602306|NCT02754492|2943725|Other|A procedure is a success if the subject's platelet product has a residual WBC count of < 12.0 × 10^6 for the triple platelet product group, or < 5.0 × 10^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|Standard Error of the Mean|0.0|||1-Sided|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|
1602307|NCT02754492|2943725|Other|A procedure is a success if the subject's platelet product has a residual WBC count of < 8.0 × 10^6 for the double platelet product group, or < 5.0 × 10^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|Standard Error of the Mean|0.0|||1-Sided|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|
1602308|NCT02754492|2943725|Other|A procedure is a success if the subject's platelet product has a residual WBC count of < 5.0 × 10^6 for the single platelet product group. The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|0.989|Standard Error of the Mean|0.0107|||1-Sided|95.0|0.95|||||||Up to 350 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|
1602309|NCT02754440|2943726|Other|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|Standard Error of the Mean|0.0|||1-Sided|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|
1602310|NCT02754440|2943726|Other|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|1.0|Standard Error of the Mean|0.0|||1-Sided|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|
1602311|NCT02754440|2943726|Other|A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%.|Simple Sample Proportion|0.957|Standard Error of the Mean|0.021|||1-Sided|95.0|0.904|||||||Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence.|
1602312|NCT02754440|2943727|Other|A procedure is a success if the subject's platelet product has a residual WBC count of < 12.0 × 10^6 for the triple platelet product group, or < 5.0 × 10^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|Standard Error of the Mean|0.0|||1-Sided|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|
1602313|NCT02754440|2943727|Other|A procedure is a success if the subject's platelet product has a residual WBC count of < 8.0 × 10^6 for the double platelet product group, or < 5.0 × 10^6 for each transfusable unit . The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|Standard Error of the Mean|0.0|||1-Sided|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|
1602314|NCT02754440|2943727|Other|A procedure is a success if the subject's platelet product has a residual WBC count of < 5.0 × 10^6 for the single platelet product group. The FDA requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple Sample Proportion|1.0|Standard Error of the Mean|0.0|||1-Sided|95.0|0.968||||||When estimated proportion is 100%, standard error of the mean is estimated as 0.|Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure.|
1602316|NCT02753075|2943762|Superiority or Other||LS mean difference|-0.09||||0.7987|2-Sided|95.0|-0.76|0.586|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1602317|NCT02753075|2943762|Superiority or Other||LS mean difference|0.02||||0.9474|2-Sided|95.0|-0.665|0.711|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1602318|NCT02753075|2943763|Superiority or Other||LS mean difference|0.25||||0.3542|2-Sided|95.0|-0.283|0.787|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1602319|NCT02753075|2943763|Superiority or Other||LS mean difference|0.2||||0.4607|2-Sided|95.0|-0.333|0.732|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1602320|NCT02753075|2943763|Superiority or Other||LS mean difference|0.45||||0.0978|2-Sided|95.0|-0.084|0.987|||ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1602321|NCT02753075|2943764|Superiority or Other||Median Difference (Net)|0.0||||0.896|2-Sided|95.0|-5.0|5.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.||
1602322|NCT02753075|2943764|Superiority or Other||Median Difference (Net)|0.0||||0.7214|2-Sided|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.||
1602323|NCT02753075|2943764|Superiority or Other||Median Difference (Net)|0.0||||0.7789|2-Sided|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.||
1602324|NCT02753075|2943765|Superiority or Other||Median Difference (Net)|0.0||||0.5693|2-Sided|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.||
1602325|NCT02753075|2943765|Superiority or Other||Median Difference (Net)|0.0||||0.438|2-Sided|95.0|-5.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.||
1602326|NCT02753075|2943765|Superiority or Other||Median Difference (Net)|0.0||||0.1688|2-Sided|95.0|-10.0|0.0||Wilcoxon rank sum test.|Wilcoxon rank sum test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. Median Difference has been calculated from non-parametric Hodges-Lehmann estimations.||
1602327|NCT02753075|2943766|Superiority or Other||LS mean difference|0.11||||0.3784|2-Sided|95.0|-0.141|0.371|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1602328|NCT02753075|2943766|Superiority or Other||LS mean difference|0.03||||0.8448|2-Sided|95.0|-0.229|0.28|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1602329|NCT02753075|2943766|Superiority or Other||LS mean difference|0.14||||0.2825|2-Sided|95.0|-0.116|0.396|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1602330|NCT02753075|2943767|Superiority or Other||LS mean difference|0.09||||0.5892|2-Sided|95.0|-0.242|0.424|||ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1602331|NCT02753075|2943768|Superiority or Other||LS mean difference|-0.01||||0.9993|2-Sided|95.0|-0.372|0.362||For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett’s multiplicity adjustment is applied.|ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1602332|NCT02753075|2943768|Superiority or Other||Least Square (LS) mean difference|0.09||||0.829|2-Sided|95.0|-0.289|0.461||For the Week 8 comparisons of two Oral Rinses against the Placebo Rinse, Dunnett’s multiplicity adjustment is applied.|ANCOVA||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1602333|NCT02752958|2943769|Other||Mean Difference (Final Values)|1.56|||<|0.0001|2-Sided|95.0|1.072|2.047|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value||
1602334|NCT02752958|2943770|Other||Mean Difference (Final Values)|1.17|||<|0.0001|2-Sided|95.0|0.678|1.653||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 20|
1602407|NCT02752048|2943875|Other|Change in time to rise from the floor from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-1.378||||0.596|2-Sided|95.0|-6.757|4.0|||t-test, 2 sided||||
1602335|NCT02752958|2943771|Other||Mean Difference (Final Values)|1.44|||<|0.0001|2-Sided|95.0|0.951|1.926|||ANOVA|[From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value||
1602336|NCT02752958|2943772|Other||Mean Difference (Final Values)|1.4|||<|0.0001|2-Sided|95.0|0.918|1.875|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 12|
1602337|NCT02752958|2943773|Other||Mean Difference (Final Values)|0.69||||0.005|2-Sided|95.0|0.21|1.171|||ANOVA|[1] From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8|
1602338|NCT02752958|2943774|Other||Mean Difference (Final Values)|0.43||||0.0786|2-Sided|95.0|-0.05|0.919|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 4|
1602339|NCT02752958|2943775|Other||Mean Difference (Final Values)|2.5|||<|0.0001|2-Sided|95.0|2.02|2.982|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24|
1602340|NCT02752958|2943776|Other||Mean Difference (Final Values)|2.21|||<|0.0001|2-Sided|95.0|1.732|2.694|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20|
1602341|NCT02752958|2943777|Other||Mean Difference (Final Values)|2.33|||<|0.0001|2-Sided|95.0|1.848|2.81|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week16|
1602342|NCT02752958|2943778|Other||Mean Difference (Final Values)|1.95|||<|0.0001|2-Sided|95.0|1.473|2.418|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 12|
1602343|NCT02752958|2943779|Other||Mean Difference (Final Values)|1.45|||<|0.0001|2-Sided|95.0|0.977|1.926|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8|
1602344|NCT02752958|2943780|Other||Mean Difference (Final Values)|1.18|||<|0.0001|2-Sided|95.0|0.703|1.66|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4|
1602345|NCT02752958|2943781|Other||Mean Difference (Final Values)|2.21|||<|0.0001|2-Sided|95.0|1.794|2.62||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24|
1602346|NCT02752958|2943782|Other||Mean Difference (Final Values)|2.06|||<|0.0001|2-Sided|95.0|1.643|2.469|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20|
1602347|NCT02752958|2943783|Other||Mean Difference (Final Values)|1.96|||<|0.0001|2-Sided|95.0|1.545|2.371|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16|
1602348|NCT02752958|2943784|Other||Mean Difference (Final Values)|1.74|||<|0.0001|2-Sided|95.0|1.333|2.145|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12|
1602349|NCT02752958|2943785|Other||Mean Difference (Final Values)|1.28|||<|0.0001|2-Sided|95.0|0.875|1.69|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8|
1602350|NCT02752958|2943786|Other||Mean Difference (Final Values)|0.88|||<|0.0001|2-Sided|95.0|0.474|1.295|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4|
1602351|NCT02752958|2943787|Other||Mean Difference (Final Values)|2.34|||<|0.0001|2-Sided|95.0|1.743|2.943|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24|
1602551|NCT02750410|2944074|Superiority||LS mean difference|-34.97|||<|0.001|2-Sided|95.0|-52.55|-17.38|||t-test, 2 sided|||Dinner 2-hour PPBG|
1602352|NCT02752958|2943788|Other||Mean Difference (Final Values)|2.34|||<|0.0001|2-Sided|95.0|1.743|2.943|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20|
1602353|NCT02752958|2943789|Other||Mean Difference (Final Values)|2.03|||<|0.0001|2-Sided|95.0|1.429|2.629|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 16|
1602354|NCT02752958|2943790|Other||Mean Difference (Final Values)|1.87|||<|0.0001|2-Sided|95.0|1.278|2.457||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12|
1602355|NCT02752958|2943791|Other||Mean Difference (Final Values)|1.42|||<|0.0001|2-Sided|95.0|0.83|2.013|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8|
1602356|NCT02752958|2943792|Other||Mean Difference (Final Values)|0.6||||0.0493|2-Sided|95.0|0.002|1.194|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 4|
1602357|NCT02752958|2943793|Other||Mean Difference (Final Values)|0.18||||0.0211|2-Sided|95.0|0.027|0.332|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 24|
1602358|NCT02752958|2943794|Other||Mean Difference (Final Values)|0.13||||0.0844|2-Sided|95.0|-0.018|0.287|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 20|
1602359|NCT02752958|2943795|Other||Mean Difference (Final Values)|0.14||||0.0682|2-Sided|95.0|-0.011|0.294|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 16|
1602360|NCT02752958|2943796|Other||Mean Difference (Final Values)|0.13||||0.0795|2-Sided|95.0|-0.016|0.284|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12|
1602361|NCT02752958|2943797|Other||Mean Difference (Final Values)|0.07||||0.3934|2-Sided|95.0|-0.085|0.216||From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 vs Week 8|
1602362|NCT02752958|2943798|Other||Mean Difference (Final Values)|0.09||||0.2326|2-Sided|95.0|-0.059|0.243|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu|Week 0 Vs Week 4|
1602363|NCT02752958|2943799|Other||Mean Difference (Final Values)|2.85|||<|0.0001|2-Sided|95.0|1.477|4.222|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 24|
1602364|NCT02752958|2943800|Other||Mean Difference (Final Values)|2.74||||0.0001|2-Sided|95.0|1.371|4.116|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.||Week 0 Vs Week 20|
1602365|NCT02752958|2943801|Other||Mean Difference (Final Values)|2.12||||0.0026|2-Sided|95.0|0.744|3.489|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 16|
1602366|NCT02752958|2943802|Other||Mean Difference (Final Values)|1.81||||0.0085|2-Sided|95.0|0.467|3.162|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 12|
1602367|NCT02752958|2943803|Other||Mean Difference (Final Values)|0.9||||0.1907|2-Sided|95.0|-0.451|2.255|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 8|
1602368|NCT02752958|2943804|Other||Mean Difference (Final Values)|0.63||||0.3676|2-Sided|95.0|-0.738|1.989|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4|
1602408|NCT02751931|2943900|Other||Mean Difference (Net)|0.95||||0.003|2-Sided|95.0|0.38|1.51||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents|
1602619|NCT02742818|2944388|Other|||||||0.999|||||||Chi-squared||||
1602369|NCT02752958|2943805|Other||Mean Difference (Final Values)|8.67|||<|0.0001|2-Sided|95.0|6.726|10.623|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 24|
1602370|NCT02752958|2943806|Other||Mean Difference (Final Values)|8.39|||<|0.0001|2-Sided|95.0|6.438|10.335|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20|
1602371|NCT02752958|2943807|Other||Mean Difference (Final Values)|7.17|||<|0.0001|2-Sided|95.0|5.219|9.115|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16|
1602372|NCT02752958|2943808|Other||Mean Difference (Final Values)|6.85|||<|0.0001|2-Sided|95.0|4.933|8.759|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12|
1602373|NCT02752958|2943809|Other||Mean Difference (Final Values)|4.42|||<|0.0001|2-Sided|95.0|2.498|6.339|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8|
1602374|NCT02752958|2943810|Other||Mean Difference (Final Values)|2.42||||0.0145|2-Sided|95.0|0.483|4.352|||ANOVA||Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 4|
1602375|NCT02752958|2943811|Other||Mean Difference (Final Values)|4.3|||<|0.0001|2-Sided|95.0|3.119|5.477|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24|
1602376|NCT02752958|2943812|Other||Mean Difference (Final Values)|4.39|||<|0.0001|2-Sided|95.0|3.21|5.568|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20|
1602377|NCT02752958|2943813|Other||Mean Difference (Final Values)|3.55|||<|0.0001|2-Sided|95.0|2.371|4.729|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 16|
1602378|NCT02752958|2943814|Other||Mean Difference (Final Values)|2.42|||<|0.0001|2-Sided|95.0|1.266|3.582|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 12|
1602379|NCT02752958|2943815|Other||Mean Difference (Final Values)|1.77||||0.0029|2-Sided|95.0|0.61|2.935|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline|Week 0 Vs Week 8|
1602380|NCT02752958|2943816|Other||Mean Difference (Final Values)|0.57||||0.3415|2-Sided|95.0|-0.604|1.738|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 vs Week 4|
1602381|NCT02752958|2943817|Other||Mean Difference (Final Values)|11.96|||<|0.0001|2-Sided|95.0|9.235|14.686|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24|
1602382|NCT02752958|2943818|Other||Mean Difference (Final Values)|11.73|||<|0.0001|2-Sided|95.0|9.008|14.459|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 20|
1602383|NCT02752958|2943819|Other|Week 0 Vs Week 16|Mean Difference (Final Values)|10.43|||<|0.0001|2-Sided|95.0|7.708|13.158|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 16|
1602384|NCT02752958|2943820|Other||Mean Difference (Final Values)|8.35|||<|0.0001|2-Sided|95.0|5.674|11.026|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Valu|Week 0 Vs Week 12|
1602385|NCT02752958|2943821|Other||Mean Difference (Final Values)|7.08|||<|0.0001|2-Sided|95.0|4.391|9.764|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 8|
1602409|NCT02751931|2943900|Other||Mean Difference (Net)|0.42||||0.106|2-Sided|95.0|-0.1|0.93||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children|
1602386|NCT02752958|2943822|Other||Mean Difference (Final Values)|1.11||||0.4185|2-Sided|95.0|-1.592|3.821|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline|Week 0 Vs Week 4|
1602387|NCT02752958|2943823|Other||Mean Difference (Final Values)|4.74|||<|0.0001|2-Sided|95.0|3.654|5.823|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs Week 24|
1602388|NCT02752958|2943824|Other||Mean Difference (Final Values)|4.15|||<|0.0001|2-Sided|95.0|3.063|5.232|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 20|
1602389|NCT02752958|2943825|Other||Mean Difference (Final Values)|3.93|||<|0.0001|2-Sided|95.0|2.844|5.012|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value||
1602390|NCT02752958|2943826|Other||Mean Difference (Final Values)|3.26|||<|0.0001|2-Sided|95.0|2.192|4.322|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 12|
1602391|NCT02752958|2943827|Other||Mean Difference (Final Values)|2.8|||<|0.0001|2-Sided|95.0|1.728|3.866|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|"Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice.~Week 0 = Baseline Value"|Week 0 Vs Week 8|
1602392|NCT02752958|2943828|Other||Mean Difference (Final Values)|1.18||||0.0312|2-Sided|95.0|0.108|2.262|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 Vs. Week 4|
1602393|NCT02752958|2943829|Other||Mean Difference (Final Values)|32.55|||<|0.0001|2-Sided|95.0|25.585|39.506|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 24|
1602394|NCT02752958|2943830|Other||Mean Difference (Final Values)|31.42|||<|0.0001|2-Sided|95.0|24.464|38.385|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit*site interaction included where significant at 10% level.||Week 0 Vs Week 20|
1602395|NCT02752958|2943831|Other||Mean Difference (Final Values)|27.21|||<|0.0001|2-Sided|95.0|20.245|34.165|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit*site interaction included where significant at 10% level|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 16|
1602396|NCT02752958|2943832|Other||Mean Difference (Final Values)|22.7|||<|0.0001|2-Sided|95.0|15.87|29.539|||ANOVA|From ANOVA model with visit and site as fixed effect and participant as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 12|
1602397|NCT02752958|2943833|Other||Mean Difference (Final Values)|16.99|||<|0.0001|2-Sided|95.0|10.128|23.849|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus other weeks score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (baseline) vs. Week 8|
1602398|NCT02752958|2943834|Other||Mean Difference (Final Values)|5.89||||0.0944|2-Sided|95.0|-1.018|12.8|||ANOVA|From ANOVA model with visit and site as fixed effect and subject as random effect. Visit*site interaction included where significant at 10% level.|Difference is the baseline score minus Week 4 score such that a positive difference favour to test dentifrice. Week 0 = Baseline Value|Week 0 (Baseline ) versus (vs.) Week 4|
1602399|NCT02752633|2943850|Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Data are presented as the urinary DHA excretion (mg/24 hr) and as the DHA-to-creatinine ratio (mg/mmol) in first morning void urine samples. Data are presented as a median (range). Differences in the median urinary DHA excretion and the urinary DHA-to-creatinine ratio between periods off pharmacotherapy and on the two study drugs, febuxostat and allopurinol, were assessed using the Wilcoxon signed rank test.|
1602400|NCT02752074|2943871|Other||Hazard Ratio (HR)|1.13||||0.80666|2-Sided|95.0|0.86|1.49||One-sided p-value based on log-rank test.|Log Rank||||
1602401|NCT02752074|2943872|Other||Hazard Ratio (HR)|1.0||||0.51711|2-Sided|95.0|0.83|1.21||One-sided p-value based on log-rank test.|Log Rank||||
1602402|NCT02752048|2943873|Other|Change in time to up and go from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.225||||0.767|2-Sided|95.0|-1.801|1.351|||t-test, 2 sided||||
1602403|NCT02752048|2943873|Other|Change in time to up and go from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.533||||0.549|2-Sided|95.0|-2.363|1.298|||t-test, 2 sided||||
1602404|NCT02752048|2943874|Other|Change in 10-m walk/run test from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.397||||0.501|2-Sided|95.0|-1.61|0.817|||t-test, 2 sided||||
1602405|NCT02752048|2943874|Other|Change in 10-m walk/run test from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|-0.484||||0.382|2-Sided|95.0|-1.618|0.65|||t-test, 2 sided||||
1602406|NCT02752048|2943875|Other|Change in time to rise from the floor from baseline to Week 24 were calculated to evaluate|Mean Difference (Final Values)|1.349||||0.433|2-Sided|95.0|-2.22|4.918|||t-test, 2 sided||||
1602411|NCT02751931|2943900|Other||Mean Difference (Net)|0.36||||0.153|2-Sided|95.0|-0.14|0.86||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children|
1602412|NCT02751931|2943901|Other||Mean Difference (Net)|-6.79||||0.056|2-Sided|95.0|-13.78|0.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents|
1602413|NCT02751931|2943901|Other||Mean Difference (Net)|1.3||||0.613|2-Sided|95.0|-3.96|6.57||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children|
1602414|NCT02751931|2943901|Other||Mean Difference (Net)|-4.9||||0.127|2-Sided|95.0|-11.34|1.53||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents|
1602415|NCT02751931|2943901|Other||Mean Difference (Net)|2.04||||0.352|2-Sided|95.0|-2.4|6.49||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children|
1602416|NCT02751931|2943902|Other||Mean Difference (Net)|2.14|||<|0.001|2-Sided|95.0|1.1|3.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents|
1602417|NCT02751931|2943902|Other||Mean Difference (Net)|1.38|||<|0.002|2-Sided|95.0|0.5|2.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children|
1602418|NCT02751931|2943902|Other||Mean Difference (Net)|1.88|||<|0.001|2-Sided|95.0|1.0|2.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents|
1602419|NCT02751931|2943902|Other||Mean Difference (Net)|1.33|||<|0.002|2-Sided|95.0|0.5|2.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children|
1602420|NCT02751931|2943902|Other||Mean Difference (Net)|2.17|||<|0.001|2-Sided|95.0|1.2|3.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents|
1602421|NCT02751931|2943902|Other||Mean Difference (Net)|1.34|||<|0.001|2-Sided|95.0|0.7|2.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children|
1602422|NCT02751931|2943902|Other||Mean Difference (Net)|1.93|||<|0.001|2-Sided|95.0|0.9|3.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents|
1602423|NCT02751931|2943902|Other||Mean Difference (Net)|1.31|||<|0.001|2-Sided|95.0|0.5|2.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children|
1602424|NCT02751931|2943902|Other||Mean Difference (Net)|2.26|||<|0.001|2-Sided|95.0|1.2|3.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents|
1602425|NCT02751931|2943902|Other||Mean Difference (Net)|1.14|||<|0.001|2-Sided|95.0|0.5|1.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children|
1602426|NCT02751931|2943902|Other||Mean Difference (Net)|1.36|||<|0.002|2-Sided|95.0|0.6|2.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents|
1602427|NCT02751931|2943902|Other||Mean Difference (Net)|0.68|||<|0.013|2-Sided|95.0|0.1|1.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children|
1602428|NCT02751931|2943902|Other||Mean Difference (Net)|0.82|||<|0.045|2-Sided|95.0|0.0|1.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents|
1602429|NCT02751931|2943902|Other||Mean Difference (Net)|0.34|||<|0.018|2-Sided|95.0|0.1|0.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children|
1602430|NCT02751931|2943903|Other||Mean Difference (Net)|-1.12||||0.064|2-Sided|95.0|-2.3|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents|
1602431|NCT02751931|2943903|Other||Mean Difference (Net)|-0.94||||0.083|2-Sided|95.0|-2.0|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children|
1602432|NCT02751931|2943903|Other||Mean Difference (Net)|-0.81||||0.07|2-Sided|95.0|-1.7|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents|
1602433|NCT02751931|2943903|Other||Mean Difference (Net)|-1.98||||0.018|2-Sided|95.0|-3.6|-0.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children|
1602434|NCT02751931|2943903|Other||Mean Difference (Net)|-0.75||||0.047|2-Sided|95.0|-1.5|0.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents|
1602435|NCT02751931|2943903|Other||Mean Difference (Net)|0.18||||0.922|2-Sided|95.0|-3.5|3.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children|
1602436|NCT02751931|2943903|Other||Mean Difference (Net)|-0.65||||0.153|2-Sided|95.0|-1.6|0.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents|
1602437|NCT02751931|2943903|Other||Mean Difference (Net)|0.37||||0.871|2-Sided|95.0|-4.2|5.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children|
1602620|NCT02742818|2944389|Other|||||||0.529|||||||Chi-squared||||
1602438|NCT02751931|2943903|Other||Mean Difference (Net)|-0.65||||0.278|2-Sided|95.0|-1.9|0.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents|
1602439|NCT02751931|2943903|Other||Mean Difference (Net)|1.16||||0.674|2-Sided|95.0|-4.4|6.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children|
1602440|NCT02751931|2943903|Other||Mean Difference (Net)|-0.87||||0.066|2-Sided|95.0|-1.8|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents|
1602441|NCT02751931|2943903|Other||Mean Difference (Net)|-1.14||||0.052|2-Sided|95.0|-2.3|0.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children|
1602442|NCT02751931|2943903|Other||Mean Difference (Net)|-0.53||||0.114|2-Sided|95.0|-1.2|0.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents|
1602443|NCT02751931|2943903|Other||Mean Difference (Net)|0.35||||0.818|2-Sided|95.0|-2.7|3.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children|
1602444|NCT02751931|2943904|Other||Mean Difference (Net)|38.14||||0.121|2-Sided|95.0|-11.0|87.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents|
1602445|NCT02751931|2943904|Other||Mean Difference (Net)|31.83||||0.042|2-Sided|95.0|1.3|62.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children|
1602446|NCT02751931|2943904|Other||Mean Difference (Net)|68.47||||0.019|2-Sided|95.0|12.7|124.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents|
1602447|NCT02751931|2943904|Other||Mean Difference (Net)|31.08||||0.203|2-Sided|95.0|-17.5|79.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children|
1602448|NCT02751931|2943904|Other||Mean Difference (Net)|86.66|||<|0.001|2-Sided|95.0|41.5|131.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents|
1602449|NCT02751931|2943904|Other||Mean Difference (Net)|40.76|||<|0.043|2-Sided|95.0|1.4|80.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children|
1602450|NCT02751931|2943904|Other||Mean Difference (Net)|38.23|||<|0.016|2-Sided|95.0|7.8|68.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents|
1602451|NCT02751931|2943904|Other||Mean Difference (Net)|8.68|||<|0.503|2-Sided|95.0|-17.3|34.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0|t-test, 2 sided|||Change From Baseline at Week 12 - Children|
1602452|NCT02751931|2943904|Other||Mean Difference (Net)|44.43|||<|0.033|2-Sided|95.0|3.9|84.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents|
1602453|NCT02751931|2943904|Other||Mean Difference (Net)|34.01|||<|0.02|2-Sided|95.0|5.7|62.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children|
1602454|NCT02751931|2943904|Other||Mean Difference (Net)|75.25|||<|0.005|2-Sided|95.0|25.8|124.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents|
1602455|NCT02751931|2943904|Other||Mean Difference (Net)|19.81|||<|0.167|2-Sided|95.0|-8.7|48.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children|
1602456|NCT02751931|2943904|Other||Mean Difference (Net)|39.52|||<|0.035|2-Sided|95.0|3.0|76.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents|
1602457|NCT02751931|2943904|Other||Mean Difference (Net)|7.98|||<|0.617|2-Sided|95.0|-24.0|40.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children|
1602458|NCT02751931|2943905|Other||Mean Difference (Net)|49.13||||0.057|2-Sided|95.0|-1.6|99.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents|
1602459|NCT02751931|2943905|Other||Mean Difference (Net)|53.76||||0.002|2-Sided|95.0|21.7|85.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children|
1602460|NCT02751931|2943905|Other||Mean Difference (Net)|50.9||||0.039|2-Sided|95.0|2.7|99.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents|
1602461|NCT02751931|2943905|Other||Mean Difference (Net)|58.49||||0.004|2-Sided|95.0|19.8|97.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children|
1602462|NCT02751931|2943905|Other||Mean Difference (Net)|81.37||||0.003|2-Sided|95.0|30.4|132.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents|
1602463|NCT02751931|2943905|Other||Mean Difference (Net)|44.2||||0.006|2-Sided|95.0|13.2|75.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children|
1602464|NCT02751931|2943905|Other||Mean Difference (Net)|43.04||||0.009|2-Sided|95.0|11.9|74.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents|
1602465|NCT02751931|2943905|Other||Mean Difference (Net)|29.05||||0.008|2-Sided|95.0|8.2|49.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children|
1602466|NCT02751931|2943905|Other||Mean Difference (Net)|38.11||||0.063|2-Sided|95.0|-2.2|78.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents|
1602467|NCT02751931|2943905|Other||Mean Difference (Net)|43.91|||<|0.001|2-Sided|95.0|21.0|66.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children|
1602468|NCT02751931|2943905|Other||Mean Difference (Net)|70.35|||<|0.006|2-Sided|95.0|22.2|118.5||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents|
1602469|NCT02751931|2943905|Other||Mean Difference (Net)|37.71|||<|0.005|2-Sided|95.0|11.7|63.7|||t-test, 2 sided|From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.||Change From Baseline at Week 4 - Children|
1602470|NCT02751931|2943905|Other||Mean Difference (Net)|35.58|||<|0.056|2-Sided|95.0|-1.1|72.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents|
1602471|NCT02751931|2943905|Other||Mean Difference (Net)|18.13|||<|0.113|2-Sided|95.0|-4.5|40.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children|
1602472|NCT02751931|2943906|Other||Mean Difference (Net)|54.3||||0.021|2-Sided|95.0|9.0|99.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents|
1602473|NCT02751931|2943906|Other||Mean Difference (Net)|53.51||||0.001|2-Sided|95.0|22.6|84.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children|
1602474|NCT02751931|2943906|Other||Mean Difference (Net)|54.78||||0.017|2-Sided|95.0|10.6|98.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents|
1602475|NCT02751931|2943906|Other||Mean Difference (Net)|60.09||||0.003|2-Sided|95.0|21.2|99.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children|
1602476|NCT02751931|2943906|Other||Mean Difference (Net)|84.39||||0.003|2-Sided|95.0|31.6|137.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents|
1602477|NCT02751931|2943906|Other||Mean Difference (Net)|49.88||||0.004|2-Sided|95.0|17.1|82.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children|
1602478|NCT02751931|2943906|Other||Mean Difference (Net)|47.29||||0.003|2-Sided|95.0|17.8|76.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents|
1602479|NCT02751931|2943906|Other||Mean Difference (Net)|33.23||||0.003|2-Sided|95.0|12.2|54.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children|
1602480|NCT02751931|2943906|Other||Mean Difference (Net)|42.86||||0.02|2-Sided|95.0|7.4|78.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents|
1602481|NCT02751931|2943906|Other|Pre-Specified|Mean Difference (Net)|45.27|||<|0.001|2-Sided|95.0|22.1|68.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children|
1602482|NCT02751931|2943906|Other||Mean Difference (Net)|73.25|||<|0.002|2-Sided|95.0|29.3|117.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents|
1602483|NCT02751931|2943906|Other||Mean Difference (Net)|46.69|||<|0.001|2-Sided|95.0|21.7|71.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children|
1602484|NCT02751931|2943906|Other||Mean Difference (Net)|42.38|||<|0.014|2-Sided|95.0|9.3|75.4||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents|
1602485|NCT02751931|2943906|Other||Mean Difference (Net)|17.5|||<|0.126|2-Sided|95.0|-5.1|40.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children|
1602486|NCT02751931|2943907|Other||Mean Difference (Net)|42.4||||0.008|2-Sided|95.0|12.5|72.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Adolescents|
1602487|NCT02751931|2943907|Other||Mean Difference (Net)|42.84|||<|0.001|2-Sided|95.0|22.0|63.7||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 52 - Children|
1602488|NCT02751931|2943907|Other||Mean Difference (Net)|52.14|||<|0.002|2-Sided|95.0|20.5|83.8||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Adolescents|
1602489|NCT02751931|2943907|Other||Mean Difference (Net)|53.87|||<|0.001|2-Sided|95.0|24.5|83.2||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 36 - Children|
1602490|NCT02751931|2943907|Other||Mean Difference (Net)|59.31|||<|0.002|2-Sided|95.0|23.8|94.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents|
1602491|NCT02751931|2943907|Other||Mean Difference (Net)|41.63|||<|0.001|2-Sided|95.0|23.3|60.0||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children|
1602492|NCT02751931|2943907|Other||Mean Difference (Net)|43.94|||<|0.001|2-Sided|95.0|19.2|68.6||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Adolescents|
1602493|NCT02751931|2943907|Other||Mean Difference (Net)|32.25|||<|0.001|2-Sided|95.0|18.2|46.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 12 - Children|
1602494|NCT02751931|2943907|Other||Mean Difference (Net)|45.1|||<|0.001|2-Sided|95.0|21.3|68.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Adolescents|
1602495|NCT02751931|2943907|Other||Mean Difference (Net)|36.9|||<|0.001|2-Sided|95.0|22.7|51.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 8 - Children|
1602496|NCT02751931|2943907|Other||Mean Difference (Net)|51.96|||<|0.001|2-Sided|95.0|24.6|79.3||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents|
1602497|NCT02751931|2943907|Other||Mean Difference (Net)|30.08|||<|0.001|2-Sided|95.0|14.7|45.5||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children|
1602498|NCT02751931|2943907|Other||Mean Difference (Net)|35.99|||<|0.003|2-Sided|95.0|13.1|58.9||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Adolescents|
1602499|NCT02751931|2943907|Other||Mean Difference (Net)|14.58|||<|0.035|2-Sided|95.0|1.0|28.1||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 2 - Children|
1602500|NCT02751931|2943908|Other|||||||0.039||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Adolescents|
1602501|NCT02751931|2943908|Other|||||||0.002||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 24 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 24 - Children|
1602502|NCT02751931|2943908|Other|||||||0.148||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Adolescents|
1602503|NCT02751931|2943908|Other||||||<|0.001||||||From a Wilcoxon signed-rank test, testing the null hypothesis that week 4 median is equal to baseline median.|Wilcoxon signed-rank test|||Change From Baseline at Week 4 - Children|
1602504|NCT02751931|2943909|Other||Mean Difference (Net)|-13.19||||0.005||95.0|-22.02|-4.36||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents|
1602505|NCT02751931|2943909|Other||Mean Difference (Net)|-18.11|||<|0.001|2-Sided|95.0|-24.87|-11.35||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children|
1602506|NCT02751931|2943909|Other||Mean Difference (Net)|-6.48|||<|0.334|2-Sided|95.0|-20.09|7.13||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents|
1602507|NCT02751931|2943909|Other||Mean Difference (Net)|-12.38|||<|0.001|2-Sided|95.0|-18.56|-6.21||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children|
1602508|NCT02751931|2943910|Other||Mean Difference (Net)|-0.77||||0.359|2-Sided|95.0|-2.49|0.94||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents|
1602509|NCT02751931|2943910|Other||Mean Difference (Net)|-1.86||||0.011|2-Sided|95.0|-3.27|-0.45||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children|
1602510|NCT02751931|2943910|Other||Mean Difference (Net)|-0.64||||0.321|2-Sided|95.0|-1.94|0.67|||t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents|
1602511|NCT02751931|2943910|Other||Mean Difference (Net)|0.44||||0.632|2-Sided|95.0|-1.4|2.28||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children|
1602512|NCT02751931|2943911|Other||Mean Difference (Net)|80.78|||<|0.001|2-Sided|95.0|39.2|122.36||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents|
1602513|NCT02751931|2943911|Other||Mean Difference (Net)|41.36|||<|0.001|2-Sided|95.0|18.75|63.97||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change from Baseline at week 4 - Children.|
1602514|NCT02751931|2943912|Other||Mean Difference (Net)|13.59|||<|0.001|2-Sided|95.0|6.75|20.42||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents|
1602515|NCT02751931|2943912|Other||Mean Difference (Net)|14.62|||<|0.055|2-Sided|95.0|-0.31|29.54||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children|
1602516|NCT02751931|2943912|Other||Mean Difference (Net)|15.16|||<|0.005|2-Sided|95.0|5.1|25.22||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Adolescents|
1602517|NCT02751931|2943912|Other||Mean Difference (Net)|-4.09|||<|0.618|2-Sided|95.0|-20.55|12.38||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 4 - Children|
1602518|NCT02751931|2943913|Other||Mean Difference (Net)|113.21|||<|0.001|2-Sided|95.0|78.95|147.47||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Adolescents|
1602519|NCT02751931|2943913|Other||Mean Difference (Net)|72.09|||<|0.001|2-Sided|95.0|45.28|98.89||From a 2-sided paired t-test, testing the null hypothesis that change from baseline is equal to 0.|t-test, 2 sided|||Change From Baseline at Week 24 - Children|
1602520|NCT02751450|2943922|Superiority or Other||Least Square (LS) Mean Difference|-1.02|||<|0.0001|2-Sided|95.0|-1.15|-0.882|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response and treatment as a factor and baseline Schiff as a covariate|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.|
1602521|NCT02751320|2943971|Superiority or Other||Mean Difference (Net)|22.96|||<|0.0001|2-Sided|95.0|16.02|29.9||From ANCOVA: Participant (random), treatment & period (fixed), Participant -level baseline SMH, period-level baseline SMH, Participant -level pre-treatment acidchallenge SMH and period-level pre-treatment acid challenge SMH (covariates) .|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.|Treatment comparison corresponding to qualifying criteria for the analysis|
1602522|NCT02751320|2943971|Superiority or Other||Mean Difference (Net)|2.21|||<|0.5335|2-Sided|95.0|-4.81|9.23||ANCOVA: Participant (random), treatment & period (fixed), Participant-level baseline SMH, period-level baseline SMH, Participant-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates)|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.||
1602523|NCT02751320|2943971|Superiority or Other||Mean Difference (Net)|-3.3|||<|0.3555|2-Sided|95.0|-10.34|3.74||From ANCOVA: Participant (random), treatment & period (fixed), subject-level baseline SMH, period-level baseline SMH, subject-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates).|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.||
1602524|NCT02751320|2943971|Superiority or Other||Mean Difference (Net)|-1.09|||<|0.7603|2-Sided|95.0|-8.11|5.94||From ANCOVA: Participant (random), treatment & period (fixed), subject-level baseline SMH, period-level baseline SMH, subject-level pre-treatment acid challenge SMH and period-level pre-treatment acid challenge SMH (covariates).|ANCOVA||Difference is first named treatment minus second named treatment such that positive difference favors the first named treatment.||
1602525|NCT02750943|2943976|Superiority or Other||Least square (LS) mean difference|-25.34|||<|0.0001|2-Sided|95.0|-30.682|-19.998||From ANCOVA analysis with treatment group, gender and baseline MGI stratification as factors baseline as covariates.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1602526|NCT02750761|2944013|Other|Bioavailability: Geometric least squares mean ratio between the Oral Group's and IV Group's dose normalized AUC from time zero to infinity.|Geometric Least Squares Mean Ratio|1.12|||||2-Sided|90.0|0.93|1.35|||||The Oral Group represented the numerator in the bioavailability ratio, and the IV Group represented the denominator.||
1602527|NCT02750618|2944036|Superiority||LS Mean|-248.47|||<|0.0001|2-Sided|95.0|-270.01|-226.93|||GEE|||Week 160|
1602528|NCT02750618|2944036|Superiority||LS Mean|-248.05|||<|0.0001|2-Sided|95.0|-272.85|-223.25|||GEE|||Week 148|
1602529|NCT02750618|2944036|Superiority||LS Mean|-267.89|||<|0.0001|2-Sided|95.0|-293.61|-242.16|||GEE|||Week 136|
1602530|NCT02750618|2944036|Superiority||LS Mean|-252.22|||<|0.0001|2-Sided|95.0|-268.51|-235.93|||GEE|||Week 124|
1602531|NCT02750618|2944036|Superiority||LS Mean|-233.91|||<|0.0001|2-Sided|95.0|-255.66|-212.16|||GEE|||Week 112|
1602532|NCT02750618|2944036|Superiority||LS Mean|-218.14|||<|0.0001|2-Sided|95.0|-248.21|-188.08|||GEE|||Week 100|
1602533|NCT02750618|2944036|Superiority||LS Mean|-237.78|||<|0.0001|2-Sided|95.0|-262.94|-212.62|||GEE|||Week 88|
1602534|NCT02750618|2944036|Superiority||LS Mean|-231.22|||<|0.0001|2-Sided|95.0|-262.51|-199.93|||GEE|||Week 76|
1602535|NCT02750618|2944036|Superiority||Difference in LS Means|-216.76|||<|0.0001|2-Sided|95.0|-241.66|-191.86|||GEE model|||Week 64|
1602536|NCT02750618|2944036|Superiority||Difference in LS Means|-216.45|||<|0.0001|2-Sided|95.0|-248.13|-184.77|||GEE model|||Week 56|
1602537|NCT02750618|2944036|Superiority||Difference in LS Means|-226.58|||<|0.0001|2-Sided|95.0|-249.11|-204.06|||GEE model|||Week 48|
1602538|NCT02750618|2944036|Superiority||Difference in LS Means|-214.99|||<|0.0001|2-Sided|95.0|-241.7|-188.28|||GEE model|||Week 40|
1602539|NCT02750618|2944036|Superiority||Difference in LS Means|-161.38|||<|0.0001|2-Sided|95.0|-186.7|-136.05|||GEE model|||Week 20|
1602540|NCT02750618|2944036|Superiority||Difference in LS Means|-83.84|||<|0.064|2-Sided|95.0|-172.55|4.88|||GEE model|||Week 12|
1602541|NCT02750618|2944036|Superiority||Difference in LS Means|-82.91|||<|0.0004|2-Sided|95.0|-128.68|-37.15|||GEE model|||Week 4|
1602542|NCT02750618|2944040|Superiority||Difference in LS Means|1.51|||<|0.0001|2-Sided|95.0|1.27|1.76||The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure. The LS Mean, SE, 95% CI and 2-sided p-value are from the GEE model.|GEE||||
1602543|NCT02750618|2944041|Superiority||Difference in LS Means|1.21|||<|0.0001|2-Sided|95.0|0.9|1.51|||GEE model||||
1602544|NCT02750618|2944042|Superiority||Difference in LS Means|-2.02|||<|0.0001|2-Sided|95.0|-2.25|-1.8||The GEE model includes the change from baseline in RSS as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure.|GEE model||||
1602545|NCT02750618|2944043|Superiority||Difference in LS Means|-1.75|||<|0.0001|2-Sided|95.0|-1.98|-1.53|||GEE model||||
1602546|NCT02750618|2944044|Superiority||Difference in LS Means|2.23|||<|0.0001|2-Sided|95.0|2.01|2.45|||GEE model|||The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure. The least squares (LS) mean, standard error (SE), 95% confidence interval (CI) and 2-sided p-value are from the GEE model.|
1602547|NCT02750618|2944045|Superiority||Difference in LS Means|2.21|||<|0.0001|2-Sided|95.0|2.07|2.35|||GEE model||||
1602548|NCT02750618|2944047|Superiority||Least Squares Mean Difference|0.96|||<|0.0001|2-Sided|95.0|0.73|1.19|||GEE model||||
1602549|NCT02750410|2944073|Superiority||LS mean difference|0.1||||0.776|2-Sided|95.0|-0.59|0.78|||Mixed Models Analysis||||
1602552|NCT02750410|2944074|Superiority||LS mean difference|-31.27|||<|0.001|2-Sided|95.0|-44.05|-18.48|||t-test, 2 sided|||Predinner BG|
1602553|NCT02750410|2944074|Superiority||LS mean difference|-50.16|||<|0.001|2-Sided|95.0|-67.85|-32.46|||t-test, 2 sided|||Lunch 2-hour PPBG|
1602554|NCT02750410|2944074|Superiority||LS mean difference|-36.82|||<|0.001|2-Sided|95.0|-49.2|-24.45|||t-test, 2 sided|||Prelunch BG|
1602555|NCT02750410|2944074|Superiority||LS mean difference|-45.38|||<|0.001|2-Sided|95.0|-61.77|-29.0|||t-test, 2 sided|||Breakfast 2-hour PPBG|
1602556|NCT02750410|2944074|Superiority||LS mean difference|-26.59|||<|0.001|2-Sided|95.0|-36.39|-16.78|||t-test, 2 sided|||Prebreakfast BG|
1602557|NCT02750410|2944075|Superiority||LS mean difference|-30.14|||<|0.001|2-Sided|95.0|-41.37|-18.91|||Mixed Models Analysis||||
1602558|NCT02750410|2944076|Superiority||Odds Ratio (OR)|0.117||||0.003|2-Sided|95.0|0.028|0.479|||Regression, Logistic|||analysis was based on repeated measures logistic regression|
1602559|NCT02750410|2944077|Superiority||LS mean percent difference|-1.5|||<|0.001|2-Sided|95.0|-1.73|-1.28|||Mixed Models Analysis||||
1602560|NCT02750306|2944092|Superiority||Difference in Least Squares Means|-15.7||||0.01354|2-Sided|95.0|-28.1|-3.3|||ANCOVA||||
1602561|NCT02750306|2944095|Superiority||Difference in Least Squares Means|28.2||||0.00128|2-Sided|95.0|11.1|45.2|||ANCOVA||||
1602562|NCT02748863|2944148|Superiority||Odds Ratio (OR)|400.58|||<|0.0001|2-Sided|95.0|47.48|3379.99|||Regression, Logistic||||
1602563|NCT02748863|2944150|Superiority||Risk Difference (RD)|36.48|||<|0.0001|2-Sided|95.0|25.19|47.76|||t-test, 2 sided||||
1602564|NCT02748863|2944150|Superiority||Risk Difference (RD)|38.75|||<|0.0001|2-Sided|95.0|27.41|50.09|||t-test, 2 sided||||
1602565|NCT02748863|2944151|Superiority||Odds Ratio (OR)|168.39|||<|0.0001|2-Sided|95.0|21.2|1337.22|||Regression, Logistic||||
1602566|NCT02748863|2944152|Superiority||Odds Ratio (OR)|717.42|||<|0.0001|2-Sided|95.0|68.0|7569.56|||Regression, Logistic||||
1602567|NCT02748356|2944170|Other|1 sample t-test|||||=|0|||||||t-test, 2 sided|This is a single group comparison|||
1602568|NCT02748317|2944172|Other|1 group t-test no comparison group|||||=|0||||||P-value is not adjusted|t-test, 2 sided||||
1602569|NCT02748213|2944174|Superiority or Other||Hazard Ratio (HR)|0.85||||0.4758|2-Sided|95.0|0.56|1.32|||Log Rank||HR calculated using Herceptin + Taxotere arm as reference.||
1602570|NCT02748213|2944176|Superiority or Other||Hazard Ratio (HR)|0.73||||0.0449|2-Sided|95.0|0.53|0.99|||Log Rank||Hazard Ratio (HR) calculated using Herceptin + Taxotere arm as reference.||
1602571|NCT02748213|2944178|Superiority or Other||Difference in Response Rates|2.2||||0.717|2-Sided|95.0|-10.17|14.56|||Chi-squared||The approximate 95% CI for the difference in response (CR or PR) rates was determined using the Hauck-Anderson correction.||
1602572|NCT02747004|2944203|Other|Informal phase 2 non-inferiority.|Hazard Ratio (HR)|1.045|||||2-Sided|95.0|0.711|1.535|||||||
1602573|NCT02747004|2944203|Superiority|||||||0.293||||||Two-sided P-value.|Log Rank|Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.|||
1602574|NCT02746679|2944223|Superiority or Other|||||||0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.|||
1602575|NCT02746679|2944224|Superiority or Other|||||||0.277|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.|||
1602576|NCT02746679|2944225|Superiority or Other||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.|||
1602577|NCT02746679|2944226|Superiority or Other||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.|||
1602578|NCT02746679|2944227|Superiority or Other|||||||0.004|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.|||
1602579|NCT02746679|2944228|Superiority or Other|||||||0.024|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.|||
1602580|NCT02746679|2944229|Superiority or Other|||||||0.003|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.|||
1602581|NCT02746679|2944230|Superiority or Other|||||||0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.|||
1602582|NCT02746679|2944231|Superiority or Other||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.|||
1602583|NCT02746679|2944232|Superiority or Other|||||||0.024|||||||Chi-squared||||
1602584|NCT02746679|2944233|Superiority or Other||||||>|0.05|||||||ANOVA||||
1602585|NCT02746679|2944234|Superiority or Other||||||>|0.05|||||||ANOVA||||
1602586|NCT02746679|2944235|Superiority or Other||||||<|0.001|||||||ANOVA|The comparison of the change from baseline to 8 weeks later between MBSR Group and wait-list control group.|||
1602587|NCT02746107|2944245|Superiority or Other||Odds Ratio (OR)|2.19||||0.004|2-Sided|95.0|1.14|2.56|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator=CHADS-VASC 1||
1602588|NCT02746107|2944245|Superiority or Other||Odds Ratio (OR)|2.37||||0.002|2-Sided|95.0|1.37|4.09|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator = CHADS-VASC 1||
1602589|NCT02746107|2944245|Superiority or Other||Odds Ratio (OR)|1.77||||0.03|2-Sided|95.0|1.06|2.98|||Regression, Logistic|Adjusted for age, gender, medical and academic degrees, someone close with stroke, speciality, period of risk estimation, number of figures.|numerator: CHADS-VASC 1||
1602590|NCT02746107|2944245|Superiority or Other||Odds Ratio (OR)|1.82||||0.024|2-Sided|95.0|1.08|3.07|||Regression, Logistic|CHA2D2S-VASC risk score 1 was the reference, adjusted for nr diagrams, nr years, age, gender, smb close with stroke, speciality, professional degree||CHA2D2S-VASC risk score 1 was the reference|
1602591|NCT02746107|2944245|Superiority or Other||Risk Difference (RD)|11.1||||0.009|2-Sided|95.0|3.2|18.8|||Chi-squared||||
1602592|NCT02746107|2944245|Superiority or Other||Risk Difference (RD)|12.4||||0.003|2-Sided|95.0|4.7|20.1|||Chi-squared||||
1602593|NCT02746107|2944245|Superiority or Other||Risk Difference (RD)|9.2||||0.033|2-Sided|95.0|1.2|17.0|||Chi-squared||||
1602594|NCT02746107|2944245|Superiority or Other||Risk Difference (RD)|9.3||||0.034|2-Sided|95.0|1.2|17.0|||Chi-squared|CHA2D2S-VASC risk score 1 was reference|positive value means higher proportion of prescription, CHA2D2S-VASC risk score 1 was reference|CHA2D2S-VASC risk score 1 was the reference|
1602595|NCT02746107|2944246|Superiority or Other||Odds Ratio (OR)|3.28|||<|0.001|2-Sided|95.0|2.25|4.78|||Regression, Logistic|adjustment for age, gender, CHA2D2s-VASC score, nr of diagrams, nr of years, presence of someone close with stroke, graduation year, speciality|||
1602596|NCT02746107|2944246|Superiority or Other||Risk Difference (RD)|15.4|||<|0.001|2-Sided|95.0|10.8|20.0|||Chi-squared||patient - (physicians themselves)||
1602597|NCT02746107|2944247|Superiority or Other||Risk Difference (RD)|3.4||||0.187|2-Sided|95.0|-1.3|8.1|||Chi-squared||(risk on 5y) - (risk on 1y)|details provided in protocol;|
1602598|NCT02746107|2944248|Non-Inferiority or Equivalence|details provided in the protocol. Noninferiority margin=+/-5%|Risk Difference (RD)|0.5||||0.83|2-Sided|95.0|-4.0|5.4|||Chi-squared||||
1602599|NCT02744755|2944303|Equivalence|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits [0.6,-0.6].|Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.096|||2-Sided|90.0|-0.08|0.24||||||ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.|
1602600|NCT02744755|2944303|Equivalence|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits [0.6,-0.6].|Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.096|||2-Sided|95.0|-0.11|0.27||||||ANCOVA model included treatment, body weight as per CRF, prior therapy as per CRF, region as per CRF as fixed effects and baseline DAS28-CRP values as covariate.|
1602601|NCT02744755|2944304|Equivalence|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits [0.6,-0.6].|Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.129|||2-Sided|90.0|-0.19|0.23||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 90% confidence interval for the LS mean difference between GP2017 and Humira is contained within the interval [-0.6; 0.6]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.|
1602602|NCT02744755|2944304|Equivalence|A 0.6 change in DAS28-CRP score is considered as no clinically meaningful difference by EULAR criteria and is therefore used as the equivalence margin limits [0.6,-0.6].|Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.129|||2-Sided|95.0|-0.24|0.27||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 12 will be concluded if the 95% confidence interval for the LS mean difference between GP2017 and Humira is contained within the interval [-0.6; 0.6]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.|
1602603|NCT02743962|2944339|Superiority or Other||Mean Difference (Net)|3.25|Standard Deviation|2.67|||2-Sided|||||||||There was a small mean baseline ICPI score difference of 1.2 points between the groups (control group 10.5, +, TW group 11.2, + 2.68). Both groups reported a reduction in their ICPI scores from baseline to twelve weeks; the control group nearly met the minimal clinically important difference of 4 points and the TW group reported nearly twice the control group’s score change (mean change control group 3.75, + 2.44, TW group 7, + 1.87).|
1602604|NCT02743962|2944339|Superiority or Other||Mean Difference (Final Values)|3.75|Standard Deviation|2.12|||2-Sided|||||||||The control group reported a mean reduction in O'Leary-Sant Insterstitial Cystitis Symptom Score from baseline to 6 weeks that met the MCID (4 points), whereas the TW group reported a reduction of 1.5 times the MCID (ISCI score change: control group 4.25, + 0.95, TW group 6.2, + 0.83). From 6 to 12 weeks the control group reported no change in ISCI score (0 + 0.95) whereas the Therapeutic Wand group ISCI socre reduced by 1.8 +1.73.|
1602605|NCT02743949|2944340|Superiority||Miettinen-Nurminen|0.96||||0.912|2-Sided|97.5|0.46|2.01||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Pearson chi-square||||
1602606|NCT02743949|2944340|Superiority||Miettinen-Nurminen|0.91||||0.782|2-Sided|97.5|0.44|1.91||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Pearson chi-square||||
1602607|NCT02743949|2944341|Superiority||Wilcoxon-Mann-Whitney odds estimator|1.0975||||0.5985|2-Sided|97.5|0.7368|1.6349||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Wilcoxon rank-sum test||||
1602608|NCT02743949|2944341|Superiority||Wilcoxon-Mann-Whitney odds estimator|1.0584||||0.748|2-Sided|97.5|0.71|1.5778||P-values were obtained using a Pearson chi-square test for each Vonoprazan treatment compared with Esomeprazole.|Wilcoxon rank-sum test||||
1602609|NCT02743702|2944358|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1602610|NCT02743221|2944372|Other||Hazard Ratio (HR)|0.56||||0.04|2-Sided|95.0|0.32|0.98|||Cox proportional hazard model||||
1602611|NCT02743221|2944373|Other|||||||0.22|||||||Fisher Exact||||
1602612|NCT02743221|2944374|Other||Hazard Ratio (HR)|1.16|||||2-Sided|95.0|0.49|2.74|||||||
1602613|NCT02743221|2944375|Other|||||||0.73|||||||Fisher Exact||||
1602614|NCT02743221|2944376|Other|This was a non-comparative study.|Hazard Ratio (HR)|0.71||||0.09|2-Sided|95.0|0.48|1.06|||Cox proportional hazard model|Cox proportional hazard model with adjustment for the stratification factors (RAS status, performance status ECOG)|||
1602615|NCT02743117|2944380|Superiority or Other||Rate Difference|-7.4|||||2-Sided|95.0|-21.6|5.9||||||Up to Day 15|
1602616|NCT02743117|2944380|Superiority or Other||Rate Difference|-8.2|||||2-Sided|95.0|-22.2|4.6||||||Up to Day 8|
1602617|NCT02743117|2944381|Superiority or Other||Rate Difference|-1.3|||||2-Sided|95.0|-8.1|1.3|||||||
1602618|NCT02742818|2944387|Other|||||||0.462|||||||Wilcoxon (Mann-Whitney)||||
1602621|NCT02742818|2944390|Other|||||||0.82|||||||Wilcoxon (Mann-Whitney)||||
1602622|NCT02742818|2944391|Other|||||||0.19|||||||Generalized Estimation Equations (GEE)|Model assuming Gaussian distribution and AR-1 correlation structure, considering repeated measures in time.|||Through inference, changes in body temperature and proportional occurrence of hypothermia during surgery were evaluated using general models of estimating equations (GEE, Liang e Zeger, 1986). Binominal and normal distributions were taken into account, respectively, and assumptions for errors normalities were verified using residual plot graphs and fitted values. The significance of other associated factors and probable outcomes were verified, including gender, age, surgery type and total surgery duration, in minutes. Since analyses were longitudinal, AR-1 working correlation matrix was created.
1602623|NCT02742519|2944450|Superiority|||||||0.2121|||||||t-test, 2 sided||||
1602624|NCT02742441|2944454|Superiority|||||||0.012|||||||Cochran-Mantel-Haenszel||||
1602625|NCT02742441|2944455|Superiority||||||<|0.001||||||Statistical significance was achieved for each of the clinical signs of psoriasis.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (plaque elevation, scaling, and erythema).|
1602626|NCT02742441|2944456|Superiority||||||<|0.001||||||"Treatment groups were compared with respect to the proportions of subjects with treatment success at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center."|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.|||
1602627|NCT02742129|2944457|Superiority|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.1||||0.4411|2-Sided|95.0|-0.37|0.16|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.|
1602628|NCT02742129|2944458|Superiority|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.49||||0.1067|2-Sided|95.0|-1.08|0.11|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.|
1602629|NCT02742129|2944460|Superiority|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Median Difference (Final Values)|0.05||||0.4282|2-Sided|95.0|-0.08|0.18|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.|
1602630|NCT02742129|2944461|Superiority|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|10.69||||0.7404|2-Sided|95.0|-53.21|74.6|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.|
1602631|NCT02742129|2944462|Superiority|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|1.06||||0.3902|2-Sided|95.0|-1.37|3.49|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.|
1602632|NCT02742129|2944463|Superiority|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|0.82||||0.4658|2-Sided|95.0|-1.41|3.05|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.|
1602633|NCT02742129|2944464|Superiority|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.29||||0.8151|2-Sided|95.0|-2.79|2.2|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.|
1602634|NCT02742129|2944465|Superiority|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|0.05||||0.9338|2-Sided|95.0|-1.16|1.27|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.|
1602635|NCT02742129|2944466|Superiority|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis|Mean Difference (Final Values)|-14.68||||0.9069|2-Sided|95.0|-263.65|234.29|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data|
1602636|NCT02742129|2944467|Superiority|The statistical analysis compared the patient level data collected during the AIR001 period to the data collected during the placebo period. The Outcome Measure data is displaying the data as collected during each study phase and is combined together based upon expected treatment assignment for analysis.|Mean Difference (Final Values)|-0.2||||0.265|2-Sided|95.0|-0.56|0.16|||Mixed Models Analysis|||The mixed models used to generate the p-values included all patients, including those with incomplete data.|
1602713|NCT02739828|2944651|Superiority||||||<|0.0001|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602781|NCT02737722|2944804|Superiority|||||||1|||||||Fisher Exact|||Day 15 (Visit 5)|
1602637|NCT02741310|2944495|Other||Geometric Least Squares Mean Ratio|0.95|||||2-Sided|90.0|0.82|1.09||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.|
1602638|NCT02741310|2944496|Other||Geometric Least Squares Mean Ratio|1.0|||||2-Sided|90.0|0.96|1.05||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.|
1602639|NCT02741310|2944497|Other||Geometric Least Squares Mean Ratio|0.98|||||2-Sided|90.0|0.93|1.03||||||The mean for each treatment was compared using a linear mixed effects model with group A (sumatriptan alone) as the reference treatment group. The linear mixed effects model included treatment (erenumab with sumatriptan vs sumatriptan alone) and period as a fixed effect and subject as a random effect.|
1602640|NCT02741310|2944499|Other|The clinical hypothesis was that there would be no clinically meaningful difference between the blood pressure effects of sumatriptan alone and the effects of a single dose of erenumab IV and sumatriptan concomitant therapy. A clinically meaningful difference was defined as the upper bound of the 90% confidence interval (CI) of treatment difference between erenumab IV and sumatriptan compared to sumatriptan alone being ≥ 5 mmHg on the time-weighted scale resting MAP.|LS Mean Difference|-0.04|||||2-Sided|90.0|-2.16|2.08||||||A linear mixed effects regression analysis was performed to assess if the time-weighted average in MAP for erenumab with sumatriptan is similar to sumatriptan alone. A two-sided 90% confidence interval (equivalent to a one-sided upper 95% CI) for the mean treatment difference was calculated using a linear mixed-effects model with fixed effects for treatment and period and a random effect for subject.|
1602641|NCT02741284|2944503|Superiority||Mean Difference (Net)|0.0||||0.99|2-Sided|95.0|-1.0|1.0|||t-test, 2 sided||||
1602642|NCT02741284|2944504|Superiority||Mean Difference (Net)|-4.7||||0.06|2-Sided|95.0|-9.6|0.1|||t-test, 2 sided||||
1602643|NCT02741284|2944505|Superiority||Mean Difference (Net)|-1.5||||0.44|2-Sided|95.0|-5.4|2.4|||t-test, 2 sided||||
1602644|NCT02741284|2944506|Superiority||Risk Ratio (RR)|5.65|||<|0.05|2-Sided|95.0|0.71|45.2|||Chi-squared|||Operative vaginal delivery|
1602645|NCT02741284|2944506|Superiority||Risk Ratio (RR)|0.0|||<|0.05|2-Sided|95.0|0.0|0.0|||Chi-squared|||Cesarean delivery for non reassuring fetal status|
1602646|NCT02741284|2944506|Superiority||Risk Ratio (RR)|0.32|||<|0.05|2-Sided|95.0|0.07|1.48|||Chi-squared|||Cesarean delivery|
1602647|NCT02741284|2944507|Non-Inferiority|Noninferiority margin 30%|Mean Difference (Final Values)|0.01|||<|0.05|2-Sided|95.0|-0.01|0.03|||t-test, 2 sided|||pH|
1602648|NCT02741284|2944508|Non-Inferiority|A noninferiority margin of 30% (mean difference <1.0 mmol/l) was pre-specified as it corresponds to an upper umbilical artery lactate cut-off value of 4.5 mmol/L, above which there is an increased risk of neonatal morbidity|Mean Difference (Final Values)|0.1||||0.69|2-Sided|95.0|-0.5|0.7|||Wilcoxon (Mann-Whitney)||||
1602649|NCT02741271|2944516|Superiority||LSM Difference|1.63||||0.197|2-Sided|95.0|-0.85|4.11|||cLDA|Secondary Outcome Measure|Between-Treatment Difference||
1602650|NCT02741271|2944517|Superiority||LSM Difference|3.33||||0.026|2-Sided|95.0|0.41|6.26|||cLDA|Secondary Outcome Measure at Week 12|Between-Treatment Difference at 4 hr Post-Dose||
1602651|NCT02741271|2944517|Superiority||LSM Difference|6.32|||<|0.001|2-Sided|95.0|4.36|8.27|||cLDA|Secondary Outcome Measure on Day 1|Between-Treatment Difference at 4 hr Post-Dose||
1602652|NCT02741271|2944518|Superiority||LSM Difference|4.2|||<|0.001|2-Sided|95.0|2.5|5.91|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 5 min Post-Dose||
1602653|NCT02741271|2944518|Superiority||LSM Difference|6.64|||<|0.001|2-Sided|95.0|4.89|8.39|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 15 min Post-Dose||
1602654|NCT02741271|2944518|Superiority||LSM Difference|6.89|||<|0.001|2-Sided|95.0|5.1|8.67|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 30 min Post-Dose||
1602655|NCT02741271|2944518|Superiority||LSM Difference|6.19|||<|0.001|2-Sided|95.0|4.09|8.28|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 60 min Post-Dose||
1602656|NCT02741271|2944518|Superiority||LSM Difference|7.04|||<|0.001|2-Sided|95.0|4.74|9.35|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 2 hr Post-Dose||
1602657|NCT02741271|2944518|Superiority||LSM Difference|6.05|||<|0.001|2-Sided|95.0|3.53|8.56|||cLDA with multiple imputation|Primary Analysis Method|Between-Treatment Difference at 4 hr Post-Dose||
1602658|NCT02741271|2944521|Superiority||LSM Difference|5.21|||<|0.001|2-Sided|95.0|3.21|7.2|||cLDA with multiple imputation|Primary Analysis Method, using the constrained Longitudinal Data Analysis (cLDA) model for missing data|Between-Treatment Difference||
1602659|NCT02741245|2944540|Other|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Differecne in M-estimates|-13.3|||<|0.001|2-Sided|95.0|-16.6|-10.1|||Shapiro-Wilk test||||
1602660|NCT02741245|2944540|Other|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Difference in M-estimates|-41.8|||<|0.001|2-Sided|95.0|-45.8|-37.9|||Shapiro-Wilk test||||
1602661|NCT02741245|2944540|Other|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|Difference in M-estimates|-14.8|||<|0.001|2-Sided|95.0|-18.0|-11.6|||Shapiro-Wilk test||||
1602662|NCT02741245|2944540|Other||Difference in M-estimates|-35.9|||<|0.001|2-Sided|95.0|-39.9|-32.0|||Shapiro-Wilk test|Robust regression model with terms for treatment, risk category and baseline, after imputing missing values by a multiple imputation approach|||
1602663|NCT02740049|2944588|Superiority|||||||0.0104||||||P value is the comparison between the IFN/TNF induction group versus VR588 (10-7M) treatment group.|Wilcoxon (Mann-Whitney)|||Statistical difference is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or a Wilcoxon signed rank test as appropriate.|
1602779|NCT02737722|2944803|Superiority|||||||0.172|||||||Wilcoxon Rank Sum Test||||
1602664|NCT02740049|2944589|Superiority|||||||0.3994||||||P value is the comparison between the IFN/TNF induction group versus the VR588 (10-7M) treatment group|Wilcoxon (Mann-Whitney)|||Statistical differences is determined using the Kruskal-Wallis test followed by Dunn's multiple comparison test or Wilcoxon signed rank test as appropriate.|
1602665|NCT02740049|2944590|Superiority|||||||0.0002||||||P value is the comparison between the IFN/TNF induction group versus the VR588 (10-7M) treatment group.|Wilcoxon (Mann-Whitney)|||Statistical differences is determined using the Kruskal–Wallis test followed by Dunn's multiple comparison test or a Wilcoxon signed rank test as appropriate.|
1602666|NCT02739984|2944600|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-13.33|Standard Error of the Mean|3.44|<|0.0001|2-Sided|95.0|-20.09|-6.56|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602667|NCT02739984|2944601|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-17.06|Standard Error of the Mean|2.98|<|0.0001|2-Sided|95.0|-22.91|-11.21|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602668|NCT02739984|2944602|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|7.37|Standard Error of the Mean|1.62|<|0.0001|2-Sided|95.0|4.19|10.56|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602669|NCT02739984|2944603|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|9.8|Standard Error of the Mean|1.45|<|0.0001|2-Sided|95.0|6.95|12.64|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602670|NCT02739984|2944604|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-13.7|Standard Error of the Mean|4.02|<|0.0001|2-Sided|95.0|-21.6|-5.8|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602671|NCT02739984|2944605|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-19.25|Standard Error of the Mean|3.41|<|0.0001|2-Sided|95.0|-25.95|-12.54|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602672|NCT02739984|2944606|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-32.56|Standard Error of the Mean|3.57|<|0.0001|2-Sided|95.0|-39.58|-25.53|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602673|NCT02739984|2944607|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-40.5|Standard Error of the Mean|3.87|<|0.0001|2-Sided|95.0|-48.11|-32.9|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602674|NCT02739984|2944608|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|64.7|||<|0.0001|2-Sided|95.0|57.7|70.3|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo||
1602675|NCT02739984|2944609|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|83.5|||<|0.0001|2-Sided|95.0|77.7|87.4|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo||
1602676|NCT02739984|2944610|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|69.1|||<|0.0001|2-Sided|95.0|60.4|75.7|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo||
1602677|NCT02739984|2944611|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Treatment Difference|77.9|||<|0.0001|2-Sided|95.0|70.0|83.5|||Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Placebo||
1602678|NCT02739984|2944612|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-33.74|Standard Error of the Mean|1.59|<|0.0001|2-Sided|95.0|-36.87|-30.6|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602679|NCT02739984|2944613|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-41.06|Standard Error of the Mean|1.44|<|0.0001|2-Sided|95.0|-43.9|-38.22|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602680|NCT02739984|2944614|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-42.12|Standard Error of the Mean|2.04|<|0.0001|2-Sided|95.0|-46.13|-38.11|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602681|NCT02739984|2944615|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-52.48|Standard Error of the Mean|1.85|<|0.0001|2-Sided|95.0|-56.1|-48.85|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602682|NCT02739984|2944616|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-46.28|Standard Error of the Mean|2.1|<|0.0001|2-Sided|95.0|-50.42|-42.15|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602683|NCT02739984|2944617|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-56.56|Standard Error of the Mean|1.89|<|0.0001|2-Sided|95.0|-60.28|-52.85|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602684|NCT02739984|2944618|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-55.8|Standard Error of the Mean|2.7|<|0.0001|2-Sided|95.0|-61.0|-50.5|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602685|NCT02739984|2944619|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-67.2|Standard Error of the Mean|2.5|<|0.0001|2-Sided|95.0|-72.1|-62.2|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602686|NCT02739984|2944620|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-53.14|Standard Error of the Mean|2.25|<|0.0001|2-Sided|95.0|-57.56|-48.71|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602687|NCT02739984|2944621|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-64.14|Standard Error of the Mean|2.05|<|0.0001|2-Sided|95.0|-68.16|-60.12|||Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Placebo||
1602688|NCT02739828|2944623|Superiority|||||||0.125|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602689|NCT02739828|2944624|Superiority|||||||0.0625|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602690|NCT02739828|2944625|Superiority|||||||0.0625|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602691|NCT02739828|2944626|Superiority|||||||0.125|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602692|NCT02739828|2944627|Superiority|||||||0.3438|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602693|NCT02739828|2944628|Superiority|||||||0.0386|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602694|NCT02739828|2944629|Superiority|||||||0.0156|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602695|NCT02739828|2944630|Superiority|||||||0.4531|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602696|NCT02739828|2944631|Superiority|||||||0.3438|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602697|NCT02739828|2944632|Superiority|||||||0.0313|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602698|NCT02739828|2944633|Superiority|||||||0.4531|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602699|NCT02739828|2944634|Superiority|||||||0.1797|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602700|NCT02739828|2944635|Superiority|||||||0.5|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602701|NCT02739828|2944636|Superiority|||||||1|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602702|NCT02739828|2944637|Superiority|||||||1|||||||Sign test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602703|NCT02739828|2944641|Superiority|||||||0.1652|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602704|NCT02739828|2944642|Superiority|||||||0.0215|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602705|NCT02739828|2944643|Superiority|||||||0.0278|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602706|NCT02739828|2944647|Superiority|||||||0.0094|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602707|NCT02739828|2944647|Superiority|||||||0.0003|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602708|NCT02739828|2944648|Superiority|||||||0.0016|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602709|NCT02739828|2944648|Superiority|||||||0.0004|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602710|NCT02739828|2944649|Superiority|||||||0.0006|||||||paired t-test|||Skin pain on average. Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602711|NCT02739828|2944649|Superiority|||||||0.0005|||||||paired t-test|||Skin pain at its worst. Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602712|NCT02739828|2944650|Superiority|||||||0.0004|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602714|NCT02739828|2944652|Superiority|||||||0.0001|||||||paired t-test|||Analysis is under the assumption of completely missing at random (deleted incomplete observations).|
1602715|NCT02739321|2944669|Superiority||Mean Difference (Final Values)|0.51||||0.001|2-Sided||||||Mixed Models Analysis||||
1602716|NCT02739321|2944670|Non-Inferiority|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely difficult, 7 = extremely easy) that was used to rate ease of use.|||||||||||||||||The mean rating of parent reported ease of us of the mattress technology was 6.04 (SE = 0.15).
1602717|NCT02739321|2944671|Non-Inferiority|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely poor, 7 = exceptional) that was used to rate tolerance.|||||||||||||||||The mean rating of parent reported tolerance of actigraph watch was 5.51 (SE = 0.13).
1602718|NCT02739321|2944672|Non-Inferiority|Non-inferiority compared to the median rating of four on the seven point scale (1 = extremely poor, 7 = exceptional) that was used to rate tolerance.|||||||||||||||||The mean rating of parent reported tolerance of mattress technology was 5.61 (SE = 0.25).
1602719|NCT02739321|2944673|Superiority|||||||0.001|||||||Mixed Models Analysis||||
1602720|NCT02739321|2944674|Superiority|||||||0.015|||||||Mixed Models Analysis||||
1602721|NCT02739321|2944675|Superiority|||||||0.471|||||||Mixed Models Analysis||||
1602722|NCT02739321|2944676|Superiority|||||||0.04|||||||Mixed Models Analysis||||
1602723|NCT02739321|2944677|Superiority|||||||0.089|||||||Mixed Models Analysis||||
1602724|NCT02739321|2944678|Superiority|||||||0.285|||||||Mixed Models Analysis||||
1602725|NCT02739321|2944679|Superiority|||||||0.1|||||||Mixed Models Analysis||||
1602726|NCT02739321|2944680|Superiority|||||||0.232|||||||Mixed Models Analysis||||
1602727|NCT02739321|2944681|Superiority||Mean Difference (Final Values)|2.82||||0.001|2-Sided||||||Mixed Models Analysis||||
1602728|NCT02739321|2944682|Superiority||Mean Difference (Final Values)|0.94||||0.058|2-Sided||||||Mixed Models Analysis||||
1602729|NCT02739321|2944683|Superiority||Median Difference (Final Values)|4.09||||0.268|2-Sided||||||Mixed Models Analysis||||
1602730|NCT02739321|2944684|Superiority||Mean Difference (Final Values)|0.12||||0.001|2-Sided||||||Mixed Models Analysis||||
1602731|NCT02739321|2944685|Superiority|||||||0.001|||||||Mixed Models Analysis||||
1602732|NCT02739321|2944686|Non-Inferiority|Hypothesized benchmark of 30%|Risk Difference (RD)|25.6|||<|0.001|2-Sided||||||t-test, 2 sided||||
1602733|NCT02739269|2944687|Superiority|||||||0.002|||||||Chi-squared||||
1602734|NCT02739269|2944688|Superiority|||||||0.479|||||||Chi-squared||||
1602735|NCT02738879|2944693|Superiority||Between Group Difference in Percentages|5.3|||=|0|2-Sided|95.0|0.5|10.1|||Miettinen and Nurminen||||
1602736|NCT02738879|2944694|Superiority||Between Group Difference in Percentages|-0.7|||=|0|2-Sided|95.0|-4.7|3.2|||Miettinen and Nurminen|||Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The analysis included imputed events after subjects discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.|
1602737|NCT02738879|2944695|Superiority||Between Group Difference in Percentages|-1.2|||=|0|2-Sided|95.0|-8.2|5.8|||Miettinen and Nurminen|||The analysis included imputed events after participants discontinued from the study medication, using a Gamma frailty model. Proportions and difference in proportions were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. The bootstrap method was used to obtain the CI and p-value.|
1602738|NCT02738879|2944696|Superiority||Event Rate Ratio|0.76|||=|0|2-Sided|95.0|0.4|1.44|||Negative Binomial Model|||The analysis was calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).|
1602739|NCT02738879|2944697|Other|95% CI|Between Group Difference in Percentages|-2.1|||||2-Sided|95.0|-9.1|5.0|||||||
1602740|NCT02738879|2944698|Superiority||Between Group Difference in the LSM|-6.5|||=|0|2-Sided|95.0|-11.9|-1.0|||LDA|||Analysis was based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.|
1602741|NCT02738879|2944699|Superiority||Between Group Difference in Percentages|18.8|||<|0.001|2-Sided|95.0|11.6|25.7|||Miettinen and Nurminen||||
1602742|NCT02738879|2944700|Superiority||Between Group Difference in Percentages|-1.2|||=|0|2-Sided|95.0|-6.2|3.7|||Miettinen and Nurminen|||Percentages and difference in percentages were calculated via the Miettinen and Nurminen stratified by AHA treatment at screening. Includes imputed events after participants discontinued from the study medication, using a Gamma frailty model. The bootstrap method was used to obtain the CI and p-value.|
1602743|NCT02738879|2944701|Superiority||Event Rate Ratio|0.83|||=|0|2-Sided|95.0|0.51|1.37|||Negative Binomial Model|||Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).|
1602744|NCT02738879|2944702|Superiority||Event Rate Ratio|0.81|||=|0|2-Sided|95.0|0.67|0.99|||Negative Binomial Model|||Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).|
1602745|NCT02738879|2944703|Superiority||Between Group Difference in the LSM|-8.0|||=|0|2-Sided|95.0|-14.6|-1.5|||LDA model|||The analysis is based on a LDA model including terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.|
1602746|NCT02738879|2944704|Superiority||Between Group Difference in Percentages|-4.1|||=|0|2-Sided|95.0|-11.2|2.9|||Miettinen and Nurminen||||
1602747|NCT02738879|2944705|Other|95% CI|Between Group Difference in Percentages|-0.3|||||2-Sided|95.0|-2.3|1.7|||||||
1602780|NCT02737722|2944804|Superiority|||||||0.3636|||||||Fisher Exact|||Day 15 (Visit 5)|
1602748|NCT02738879|2944706|Superiority||Event Rate Ratio|0.73|||=|0|2-Sided|95.0|0.54|0.98|||Negative Binomial Model|||Calculated via the Negative Binomial Model including terms for treatment, race (i.e., White and Other), region (i.e., Europe, North America, and Other), AHA treatment at screening, baseline A1C value and baseline body weight and an offset for follow-up time (on the natural log scale).|
1602749|NCT02738879|2944707|Superiority|Hypothesis B: After 30 weeks, continuing sitagliptin results in a greater reduction of A1C relative to withdrawing sitagliptin.|Between Group Difference in the LSM|-0.46|||<|0.001|2-Sided|95.0|-0.58|-0.34|||LDA|||A LDA model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening.|
1602750|NCT02738879|2944707|Non-Inferiority|Hypothesis A: After 30 weeks, continuing sitagliptin is non-inferior relative to withdrawing sitagliptin on the change from baseline in A1C. Non-inferiority is declared if the upper bound of the two-sided 95% CI for the difference is less than 0.3%.|Between Group Difference in the LSM|-0.46|||<||2-Sided|95.0|-0.58|-0.34||||||A longitudinal data analysis (LDA) model included terms for treatment, AHA treatment at screening (Met + DPP-4i, Met + DPP-4i + SU, Met + SU), time, and the interactions of time by treatment and of time by AHA treatment at screening. Least Squares Means = LSM|
1602751|NCT02738580|2944721|Superiority||||||<|0.49|||||||t-test, 1 sided||||
1602752|NCT02738580|2944722|Superiority||Mean Difference (Final Values)|0.29|Standard Deviation|0.26|<|0.05|2-Sided|||||The proportion of patients with elevated Progesterone on last day of stimulation(>1.5 ng/mL) was compared between both groups using the Chi-square test.|t-test, 2 sided||||
1602753|NCT02738333|2944745|Non-Inferiority|A sample size of 100 participants per treatment group would provide over 90% power to establish non-inferiority in the SVR12 rates between the LDV/SOF group and SOF+RBV group. Sample size was based on the assumptions that the clinically meaningful non-inferiority margin is 10%, both groups have a SVR12 rate of 96%, and the significance level is 0.025 one-sided.|Difference in proportions|0.9|||||2-Sided|95.0|-5.3|7.1|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.||
1602754|NCT02738151|2944772|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.052||0.3302|2-Sided|95.0|-0.152|0.051|||Mixed Models Analysis|||Superiority of Toujeo over Tresiba was demonstrated if the upper bound of the two-sided 95% CI for the difference in the mean change in HbA1c from baseline to Week 24 between Toujeo over Tresiba on ITT population was <0 (zero).|
1602755|NCT02738151|2944772|Non-Inferiority|Non-inferiority of Toujeo vs Tresiba was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was <0.3%.|Least Square (LS) Mean difference|-0.05|Standard Error of the Mean|0.052|<|0.0001|2-Sided|95.0|-0.152|0.051||Threshold for significance at 0.025 level.|Mixed Models Analysis||Toujeo vs. Tresiba|A hierarchical step-down testing procedure was used to control type 1 error. Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit, and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates.|
1602756|NCT02737891|2944791|Superiority||Mean Difference (Net)|-3.5|||<|0.0001|2-Sided|95.0|-4.65|-2.3||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.|
1602757|NCT02737891|2944792|Superiority||Mean Difference (Net)|0.1||||0.724|2-Sided|95.0|-0.23|0.33||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.|
1602758|NCT02737891|2944793|Superiority||Mean Difference (Net)|-3.8||||0.004|2-Sided|95.0|-6.36|-1.29||Two-sided p-value for test of no difference from 0.|ANCOVA|||The analysis was based on a parametric model, i.e. compared between treatment arms by means of an analysis of covariance (ANCOVA) model (proc MIXED) using change from baseline to the end of treatment as dependent variable, treatment and study site as fixed effects and the value from baseline as covariate. The residual errors were assumed independent and identically distributed (i.i.d.) and normally distributed.|
1602759|NCT02737722|2944796|Superiority|||||||0.465|||||||Wilcoxon Rank Sum Test||||
1602760|NCT02737722|2944796|Superiority|||||||0.464|||||||Wilcoxon Rank Sum Test||||
1602761|NCT02737722|2944796|Superiority|||||||0.465|||||||Wilcoxon Rank Sum Test||||
1602762|NCT02737722|2944798|Superiority|||||||0.465|||||||Wilcoxon Rank Sum Test||||
1602763|NCT02737722|2944798|Superiority|||||||0.464|||||||Wilcoxon Rank Sum Test||||
1602764|NCT02737722|2944798|Superiority|||||||0.465|||||||Wilcoxon Rank Sum Test||||
1602765|NCT02737722|2944799|Superiority|||||||0.153|||||||Wilcoxon Rank Sum Test||||
1602766|NCT02737722|2944799|Superiority|||||||0.519|||||||Wilcoxon Rank Sum Test||||
1602767|NCT02737722|2944799|Superiority|||||||0.361|||||||Wilcoxon Rank Sum Test||||
1602768|NCT02737722|2944800|Superiority|||||||0.465|||||||Wilcoxon Rank Sum Test||||
1602769|NCT02737722|2944800|Superiority|||||||0.464|||||||Wilcoxon Rank Sum Test||||
1602770|NCT02737722|2944800|Superiority|||||||0.464|||||||Wilcoxon Rank Sum Test||||
1602771|NCT02737722|2944801|Superiority|||||||0.153|||||||Wilcoxon Rank Sum Test||||
1602772|NCT02737722|2944801|Superiority|||||||0.519|||||||Wilcoxon Rank Sum Test||||
1602773|NCT02737722|2944801|Superiority|||||||0.519|||||||Wilcoxon Rank Sum Test||||
1602774|NCT02737722|2944802|Superiority|||||||0.715|||||||Wilcoxon Rank Sum Test||||
1602775|NCT02737722|2944802|Superiority|||||||0.435|||||||Wilcoxon Rank Sum Test||||
1602776|NCT02737722|2944802|Superiority|||||||0.432|||||||Wilcoxon Rank Sum Test||||
1602777|NCT02737722|2944803|Superiority|||||||0.619|||||||Wilcoxon Rank Sum Test||||
1602778|NCT02737722|2944803|Superiority|||||||0.365|||||||Wilcoxon Rank Sum Test||||
1602782|NCT02737722|2944804|Superiority|||||||1|||||||Fisher Exact|||Day 9 (Visit 4)|
1602783|NCT02737722|2944804|Superiority|||||||1|||||||Fisher Exact|||Day 9 (Visit 4)|
1602784|NCT02737722|2944804|Superiority|||||||1|||||||Fisher Exact|||Day 2 (Visit 3)|
1602785|NCT02737722|2944804|Superiority|||||||1|||||||Fisher Exact|||Day 2 (Visit 3)|
1602786|NCT02737722|2944804|Superiority|||||||1|||||||Fisher Exact|||Day 1 (Visit 2)|
1602787|NCT02737722|2944804|Superiority|||||||0.5152|||||||Fisher Exact|||Day 1 (Visit 2)|
1602788|NCT02736825|2944852|Non-Inferiority|Non-inferiority margin of 15% between two independent percentages using the z-test with unpooled variance||||||0.367|||||||Z-test||||
1602789|NCT02736188|2944867|Superiority||difference in LS means|2.08||||0.0168|2-Sided|95.0|0.38|3.79||Baseline is fit into the model as a covariate.|GEE model|||Week 48|
1602790|NCT02736188|2944867|Superiority||difference in LS means|0.15||||0.8846|2-Sided|95.0|-1.92|2.23||Baseline is fit into the model as a covariate.|GEE model|||Week 24|
1602791|NCT02736188|2944867|Superiority||difference in LS means|0.66||||0.3531|2-Sided|95.0|-0.74|2.07||Baseline is fit into the model as a covariate.|GEE model|||Week 16|
1602792|NCT02736188|2944867|Superiority||difference in LS means|0.19||||0.7906|2-Sided|95.0|-1.22|1.6||Baseline is fit into the model as a covariate.|GEE model|||Week 8|
1602793|NCT02736188|2944868|Superiority||difference in LS means|0.72||||0.7022|2-Sided|95.0|-2.96|4.4||Baseline is fit into the model as a covariate.|GEE model|||Week 48|
1602794|NCT02736188|2944868|Superiority||difference in LS means|0.8||||0.5122|2-Sided|95.0|-1.58|3.17||Baseline is fit into the model as a covariate.|GEE model|||Week 24|
1602795|NCT02736188|2944868|Superiority||difference in LS means|-0.2||||0.8188|2-Sided|-1.89|-1.89|1.49||Baseline is fit into the model as a covariate.|GEE model|||Week 16|
1602796|NCT02736188|2944868|Superiority||difference in LS means|1.14||||0.1502|2-Sided|95.0|-0.41|2.69||Baseline is fit into the model as a covariate.|GEE model|||Week 8|
1602797|NCT02736188|2944869|Superiority||difference in LS means|0.99||||0.4687|2-Sided|95.0|-1.69|3.68||Baseline is fit into the model as a covariate.|GEE model|||Week 48|
1602798|NCT02736188|2944869|Superiority||difference in LS means|0.58||||0.4409|2-Sided|95.0|-0.89|2.04||Baseline is fit into the model as a covariate.|GEE model|||Week 24|
1602799|NCT02736188|2944869|Superiority||difference in LS means|-0.25||||0.7334|2-Sided|95.0|-1.72|1.21||Baseline is fit into the model as a covariate.|GEE model|||Week 16|
1602800|NCT02736188|2944869|Superiority||difference in LS means|0.28||||0.6428|2-Sided|95.0|-0.9|1.46||Baseline is fit into the model as a covariate.|GEE model|||Week 8|
1602801|NCT02736188|2944870|Superiority||difference in LS means|7.98||||0.443|2-Sided|95.0|-12.41|28.37||Baseline is fit into the model as a covariate.|GEE model|||Week 48|
1602802|NCT02736188|2944870|Superiority||difference in LS means|4.15||||0.4399|2-Sided|95.0|-6.39|14.69||Baseline is fit into the model as a covariate.|GEE model|||Week 24|
1602803|NCT02736188|2944870|Superiority||difference in LS means|-1.99||||0.7118|2-Sided|95.0|-12.53|8.55||Baseline is fit into the model as a covariate.|GEE model|||Week 16|
1602804|NCT02736188|2944870|Superiority||difference in LS means|2.0||||0.6434|2-Sided|95.0|-6.48|10.49||Baseline is fit into the model as a covariate.|GEE model|||Week 8|
1602805|NCT02736188|2944871|Superiority||difference in LS means|-0.41||||0.7429|2-Sided|95.0|-2.86|2.04||Baseline is fit into the model as a covariate.|GEE model|||Week 48|
1602806|NCT02736188|2944871|Superiority||difference in LS means|0.27||||0.7478|2-Sided|95.0|-1.36|1.9||Baseline is fit into the model as a covariate.|GEE model|||Week 24|
1602807|NCT02736188|2944871|Superiority||difference in LS means|-0.56||||0.5051|2-Sided|95.0|-2.22|1.09||Baseline is fit into the model as a covariate.|GEE model|||Week 16|
1602808|NCT02736188|2944871|Superiority||difference in LS means|0.45||||0.5447|2-Sided|95.0|-1.0|1.9||Baseline is fit into the model as a covariate.|GEE model|||Week 8|
1602809|NCT02736188|2944872|Superiority||difference in LS means|-0.03||||0.9568|2-Sided|95.0|-1.25|1.18||Baseline is fit into the model as a covariate.|GEE model|||Week 48|
1602810|NCT02736188|2944872|Superiority||difference in LS means|0.47||||0.1999|2-Sided|95.0|-0.25|1.2||Baseline is fit into the model as a covariate.|GEE model|||Week 24|
1602811|NCT02736188|2944872|Superiority||difference in LS means|-0.18||||0.6154|2-Sided|95.0|-0.86|0.51||Baseline is fit into the model as a covariate.|GEE model|||Week 16|
1602812|NCT02736188|2944872|Superiority||difference in LS means|0.06||||0.8603|2-Sided|95.0|-0.65|0.78||Baseline is fit into the model as a covariate.|GEE model|||Week 8|
1602813|NCT02736188|2944873|Superiority||difference in LS means|4.15||||0.0864|2-Sided|95.0|-0.59|8.9||Baseline is fit into the model as a covariate.|GEE model|||Week 48|
1602814|NCT02736188|2944873|Superiority||difference in LS means|-0.5||||0.8441|2-Sided|95.0|-5.45|4.45||Baseline is fit into the model as a covariate.|GEE model|||Week 24|
1602815|NCT02736188|2944873|Superiority||difference in LS means|-0.64||||0.7054|2-Sided|95.0|-3.97|2.69||Baseline is fit into the model as a covariate.|GEE model|||Week 16|
1602816|NCT02736188|2944873|Superiority||difference in LS means|0.78||||0.6546|2-Sided|95.0|-2.65|4.22||Baseline is fit into the model as a covariate.|GEE model|||Week 8|
1602817|NCT02736188|2944874|Superiority||difference in LS means|-0.34||||0.6416|2-Sided|95.0|-1.78|1.1||Baseline is fit into the model as a covariate.|GEE model|||Week 48|
1602818|NCT02736188|2944874|Superiority||difference in LS means|0.44||||0.4317|2-Sided|95.0|-0.65|1.52||Baseline is fit into the model as a covariate.|GEE model|||Week 24|
1602819|NCT02736188|2944874|Superiority||difference in LS means|0.74||||0.0692|2-Sided|95.0|-0.06|1.55||Baseline is fit into the model as a covariate.|GEE model|||Week 16|
1602820|NCT02736188|2944874|Superiority||Difference in LS Means|0.7||||0.0648|2-Sided|95.0|-0.04|1.45||Baseline is fit into the model as a covariate.|GEE model|||Week 8|
1602821|NCT02736188|2944875|Superiority||LS Mean Difference|-0.28||||0.6977|2-Sided|95.0|-1.69|1.13||Baseline is fit into the model as a covariate.|GEE model|||Week 48|
1602822|NCT02736188|2944875|Superiority||LS Mean Difference|-0.44||||0.276|2-Sided|95.0|-1.22|0.35|||GEE model|Baseline is fit into the model as a covariate.||Week 24|
1602823|NCT02736188|2944875|Superiority||LS Mean Difference|-0.19||||0.6611|2-Sided|95.0|-1.02|0.64||Baseline is fit into the model as a covariate.|GEE model|||Week 16|
1602824|NCT02736188|2944875|Superiority||LS Mean Difference|-0.27||||0.4721|2-Sided|95.0|-1.01|0.47||Baseline is fit into the model as a covariate.|GEE model|||Week 8|
1602825|NCT02736188|2944876|Superiority||LS Mean Difference|-0.06||||0.9747|2-Sided|95.0|-3.49|3.38||Baseline is fit into the model as a covariate.|GEE model|||Week 48|
1602826|NCT02736188|2944876|Superiority||LS Mean Difference|-0.91||||0.4253|2-Sided|95.0|-3.14|1.32||Baseline is fit into the model as a covariate.|GEE model|||Week 24|
1602827|NCT02736188|2944876|Superiority||LS Mean Difference|0.36||||0.7031|2-Sided|95.0|-1.49|2.21||Baseline is fit into the model as a covariate.|GEE model|||Week 16|
1602828|NCT02736188|2944876|Superiority||LS Mean Difference|0.8||||0.4287|2-Sided|95.0|-1.17|2.77||Baseline is fit into the model as a covariate.|generalized estimating equation (GEE)|||Week 8|
1602829|NCT02735421|2944905|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1602830|NCT02735382|2944906|Superiority||Mean Difference (Final Values)|0.44|Standard Error of the Mean|0.161||0.007|2-Sided|95.0|0.123|0.757|||t-test, 2 sided|df=292||A change score from baseline to 6-months was computed and served as the data to be analyzed in the t-test of group differences.|
1602831|NCT02735382|2944907|Superiority||Odds Ratio (OR)|0.885||||0.8438|2-Sided|95.0|0.42|1.698|||Chi-squared, Corrected||||
1602832|NCT02735382|2944908|Superiority||Odds Ratio (OR)|3.284|||<|0.0001|2-Sided|95.0|2.672|4.035|||Chi-squared, Corrected||||
1602833|NCT02735382|2944909|Superiority||Odds Ratio (OR)|4.663|||<|0.0001|2-Sided|95.0|4.116|5.283|||Chi-squared, Corrected||||
1602834|NCT02735200|2944910|Superiority||Mean Difference (Final Values)|26.66|||<|0.001|2-Sided|||||p value corresponds to the post treatment time frame.|t-test, 2 sided||||
1602835|NCT02735200|2944910|Superiority||Mean Difference (Final Values)|1.67|||<|0.9|2-Sided|||||the p value correspond to the pretreatment time frame.|t-test, 2 sided||||
1602836|NCT02735187|2944921|Superiority|A paired t-test was applied to test the primary hypothesis. In case the requirements for normality were not met, a non-parametric analysis (Wilcoxon signed rank test) was performed.||||||0.6469||||||A probability (P-Value) above 0.05 is considered not to be statistical significant.|t-test, 2 sided||||
1602837|NCT02735044|2944936|Superiority|Superiority of HOE901-U300 versus Lantus was demonstrated if the upper bound of the two-sided 95% CI for the difference between treatment groups was <0 (zero).||||||0.965||||||Threshold for significance at 0.025 level.|ANCOVA|||A step-wise closed testing approach was used to control the type I error. Analysis was performed using ANCOVA models which included the treatment group, the randomization stratum of age group at screening visit (<12 years and >=12 years), and the continuous fixed covariates of the baseline HbA1c value.|
1602838|NCT02735044|2944936|Non-Inferiority|Non-inferiority of HOE901-U300 versus Lantus was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference in the mean change in HbA1c from baseline to month 6 was <0.3%.|LS Mean difference|0.004|Standard Error of the Mean|0.09|||2-Sided|95.0|-0.172|0.179||||||Analysis was performed using ANCOVA models which included the treatment group, the randomization stratum of age group at screening visit (<12 years and >=12 years), and the continuous fixed covariates of the baseline HbA1c value.|
1602839|NCT02734693|2944959|Superiority||Mean Difference (Net)|24.05|Standard Error of the Mean|7.389||0.002|2-Sided|95.0|9.381|38.714|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), PERMP at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol|
1602840|NCT02734693|2944959|Superiority||Mean Difference (Final Values)|23.67|Standard Error of the Mean|7.395||0.002|2-Sided|95.0|8.987|38.346|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), PERMP at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol|
1602841|NCT02734693|2944962|Superiority||Mean Difference (Final Values)|-5.18|Standard Error of the Mean|1.2|<|0.001|2-Sided|95.0|-7.565|-2.802|||ANCOVA|||Least squares means, SEs, effect sizes, 95% CIs, and p-values were generated using an ANCOVA model, with treatment (dasotraline/placebo), mean SKAMP-CS at baseline, and site as fixed effects. The dasotraline 6 mg/day treatment arm was discontinued in Version 3.00 of the protocol.|
1602842|NCT02733991|2944999|Superiority||Mean Difference (Final Values)|38.8||||0.0474|2-Sided|95.0|0.46|77.11|||Mixed Models Analysis||Model based Estimated mean; Difference = Treatment arm - Control arm||
1602843|NCT02733991|2944999|Non-Inferiority|Non-inferiority margin of 40 min/day|Mean Difference (Final Values)|-38.8|||||1-Sided|97.5||-0.46|||||Model based Estimated mean; difference = control arm - treatment arm||
1602844|NCT02733991|2945000|Superiority||Mean Difference (Final Values)|-42.62|||<|0.0001|2-Sided|95.0|-52.01|-33.19|||Mixed Models Analysis||Model based Estimated mean; Treatment arm - Control arm||
1602845|NCT02733991|2945001|Superiority||Mean Difference (Final Values)|-2.88|||<|0.0001|2-Sided|95.0|-3.51|-2.25|||Mixed Models Analysis||Model based Estimated mean; Treatment arm - Control arm||
1602846|NCT02733042|2945043|Other|||||||||||||||||The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).|For Arm C the RP2D was confirmed as rituximab 375 mg/m² + bendamustine 70 mg/m².
1602847|NCT02733042|2945043|Other|||||||||||||||||The safety review committee identified a preliminary recommended Phase 2 dose (RP2D) for each dose finding cohort based on an integrated assessment of the safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy (as available).|For Arm B, ibrutinib 420 mg was confirmed as the RP2D for CLL/SLL participants and ibrutinib 560 mg was confirmed as the RP2D for MCL participants.
1602848|NCT02732951|2945045|Other||Adjusted Mean|16.45|Standard Error of the Mean|16.45||0.3199|2-Sided|95.0|-16.23|49.13|||Mixed model for repeated measurements|Kenward−Roger approximation was used for denominator degrees of freedom.|Fixed effects of treatment, prior anti-diabetic macular oedema treatment status, visit, treatment by visit interaction, baseline, baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within patient errors.|Null hypothesis = The CSFT change from baseline at Week 12 is equal in both groups|
1603587|NCT02729038|2945379|Other||Ratio of geometric LS means|1.924|||||2-Sided|90.0|1.151|3.215|||||AUC (0-inf) for participants with normal renal function Vs participants with Severe/ESRD not on hemodialysis||
1602849|NCT02732145|2945106|Superiority|Question: Is there a difference in the incidence of the finding of nerve fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0613|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of nerve fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.|
1602850|NCT02732145|2945106|Superiority|Question: Is there a difference in the incidence of sebaceous glands in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8213|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of sebaceous glands in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.|
1602851|NCT02732145|2945106|Superiority|Question: Is there a difference in the incidence of blood vessels in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0219|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of blood vessels in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.|
1602852|NCT02732145|2945106|Superiority|Question: Is there a difference in the incidence of inflammatory cells in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8672|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.|
1602853|NCT02732145|2945106|Superiority|Question: Is there a difference in the incidence of the finding of collagen fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.1067|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.|
1602854|NCT02732145|2945106|Superiority|Question: Is there a difference in the incidence of the finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0032|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.|
1602855|NCT02732145|2945106|Superiority|Question: Is there a difference in the incidence of the finding of inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.0045|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens from patients with vulvodynia depending on the duration of vulvar discomfort.|
1602856|NCT02732145|2945107|Superiority|Question: Is there a difference in the incidence of the finding of hyalinization in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.8672|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.|
1602857|NCT02732145|2945107|Superiority|Question: Is there a difference in the incidence of the finding of collagen fibers in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.3607|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.|
1602858|NCT02732145|2945107|Superiority|Question: Is there a difference in the incidence of the finding of lymphocytes in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.4271|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of lymphocytes in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.|
1602859|NCT02732145|2945107|Superiority|Question: Is there a difference in the incidence of the finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.7469|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.|
1602860|NCT02732145|2945107|Superiority|Question: Is there a difference in the incidence of the finding of inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort for less or more than 24 months?||||||0.2045|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens from patients with vulvar dermatosis depending on the duration of vulvar discomfort.|
1602861|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6468|||||||Chi-squared|||Parameter: The incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602862|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0297|||||||Chi-squared|||Parameter: The incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602863|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0218|||||||Chi-squared, Corrected|||Parameter: The incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602864|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0002|||||||Chi-squared|||Parameter: The incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602865|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of symptoms of the sharp pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0012|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the sharp (fast) pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602866|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.5304|||||||Chi-squared|||Parameter: The incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602867|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.3458|||||||Chi-squared|||Parameter: The incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602868|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6734|||||||Chi-squared|||Parameter: The incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602869|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.0921|||||||Chi-squared|||Parameter: The incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602870|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.3953|||||||Chi-squared|||Parameter: The incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602871|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.9048|||||||Chi-squared|||Parameter: The incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602872|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of vulvar burning on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.1848|||||||Chi-squared|||Parameter: The incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602873|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of symptoms of the dull pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0.6921|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull (slow) pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602874|NCT02732145|2945108|Superiority|Question: Is there a difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvodynia.|
1602875|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8925|||||||Chi-squared|||Parameter: The incidence of the vulvar pain like sticking depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602876|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9139|||||||Chi-squared|||Parameter: The incidence of vulvar pain like stabbing depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602877|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9402|||||||Chi-squared|||Parameter: The incidence of the vulvar paper-cuts pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602878|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.0331|||||||Chi-squared, Corrected|||Parameter: The incidence of the vulvar knife-like pain depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602879|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of the sharp pain of the vulva depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.4613|||||||Chi-squared|||Parameter: The difference in the incidence of the sharp (fast) pain of the vulva (knife-like pain, paper-cuts pain, stabbing, sticking) depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602880|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.7617|||||||Chi-squared|||Parameter: The incidence of vulvar aching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602881|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8389|||||||Chi-squared|||Parameter: The incidence of the feeling of vulvar inflammation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602901|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of acanthosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of acanthosis in vulvar specimens of patients from different groups.|
1602882|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9402|||||||Chi-squared|||Parameter: The incidence of vulvar itching depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602883|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.8599|||||||Chi-squared|||Parameter: The incidence of vulvar irritation depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602884|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.9684|||||||Chi-squared|||Parameter: The incidence of vulvar soreness depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602885|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.5641|||||||Chi-squared|||Parameter: The incidence of vulvar stinging depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602886|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0.3533|||||||Chi-squared|||Parameter: The incidence of vulvar burning depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602887|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of symptoms of the dull pain of the vulva on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||1|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull (slow) pain of the vulva (burning, stinging, soreness, irritation, itching, inflammation, aching) depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602888|NCT02732145|2945109|Superiority|Question: Is there a difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar complaints depending on the histopathology of the epidermis (normal versus abnormal) in patients with vulvar dermatosis.|
1602889|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of nerve fibers in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of nerve fibers in vulvar specimens of patients from different groups.|
1602890|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of sebaceous glands in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of sebaceous glands in vulvar specimens of patients from different groups.|
1602891|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of blood vessels in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of blood vessels in vulvar specimens of patients from different groups.|
1602892|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of elongated dermal papillae in vulvar specimens of patients from different groups?||||||0.0148|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of elongated dermal papillae in vulvar specimens of patients from different groups.|
1602893|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of hyperpigmentation in vulvar specimens of patients from different groups?||||||0.0342|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyperpigmentation in vulvar specimens of patients from different groups.|
1602894|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of hyalinization in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyalinization in vulvar specimens of patients from different groups.|
1602895|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of collagen fibers in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of collagen fibers in vulvar specimens of patients from different groups.|
1602896|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of mastocytes in vulvar specimens of patients from different groups?||||||0.0064|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mastocytes in vulvar specimens of patients from different groups.|
1602897|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of lymphocytes in vulvar specimens of patients from different groups?||||||0.0105|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of lymphocytes (infiltrates) in vulvar specimens of patients from different groups.|
1602898|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of mononuclear inflammatory infiltrates in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of mononuclear inflammatory infiltrates in vulvar specimens of patients from different groups.|
1602899|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of inflammatory infiltrates in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of inflammatory infiltrates in vulvar specimens of patients from different groups.|
1602900|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of epidermal atrophy in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of epidermal atrophy in vulvar specimens of patients from different groups.|
1603689|NCT02722330|2945690|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||750 Hz|
1602902|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of parakeratosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of parakeratosis in vulvar specimens of patients from different groups.|
1602903|NCT02732145|2945110|Equivalence|Question: Is there a difference in the incidence of hyperkeratosis in vulvar specimens of patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of the histopathological finding of hyperkeratosis in vulvar specimens of patients from different groups.|
1602904|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with normal vulva and positive AWR?||||||0.0078|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with normal vulva and positive AWR.|
1602905|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with normal vulva and positive AWR.|
1602906|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with normal vulva and positive AWR.|
1602907|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.022|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with normal vulva and positive AWR.|
1602908|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with normal vulva and positive AWR?||||||0.1822|||||||t|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with normal vulva and positive AWR.|
1602909|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with normal vulva and positive AWR?||||||0.1692|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with normal vulva and positive AWR.|
1602910|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.0563|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with normal vulva and positive AWR.|
1602911|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.0563|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with normal vulva and positive AWR.|
1602912|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with normal vulva and positive AWR?||||||0.6862|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with normal vulva and positive AWR.|
1602913|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with normal vulva and positive AWR?||||||0.0078|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with normal vulva and positive AWR.|
1602914|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with normal vulva and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with normal vulva and positive AWR.|
1602915|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with normal vulva and positive AWR?||||||0.5762|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with normal vulva and positive AWR.|
1602916|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with normal vulva and positive AWR?||||||0.5762|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with normal vulva and positive AWR.|
1602917|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with normal vulva and positive AWR?||||||0.0772|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with normal vulva and positive AWR.|
1602918|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with normal vulva and positive AWR?||||||0.1692|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with normal vulva and positive AWR.|
1602919|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.2714|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with impaired vulvar skin and positive AWR.|
1602920|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.0125|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with impaired vulvar skin and positive AWR.|
1603690|NCT02722330|2945690|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||500 Hz|
1602921|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.0125|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.|
1602922|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.0852|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.|
1602923|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.8732|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with impaired vulvar skin and positive AWR.|
1602924|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR?||||||0.2081|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR.|
1602925|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.0079|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.|
1602926|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.0602|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.|
1602927|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR?||||||0.8732|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR.|
1602928|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with impaired vulvar skin and positive AWR?||||||0.0287|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with impaired vulvar skin and positive AWR.|
1602929|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR?||||||0.2734|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with impaired vulvar skin and positive AWR.|
1602930|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR?||||||0.7512|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with impaired vulvar skin and positive AWR.|
1602931|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with impaired vulvar skin and positive AWR?||||||0.6374|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with impaired vulvar skin and positive AWR.|
1602932|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR?||||||0.0287|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with impaired vulvar skin and positive AWR.|
1602933|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with impaired vulvar skin and positive AWR?||||||0.0191|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with impaired vulvar skin and positive AWR.|
1602934|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvodynia and positive AWR?||||||0.7726|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvodynia and positive AWR.|
1602935|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Hymenal Remnants versus Vestibule in patients with vulvodynia and positive AWR?||||||0.0877|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Hymenal Remnants versus Vestibule in patients with vulvodynia and positive AWR.|
1602936|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.3594|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Hymenal Remnants in patients with vulvodynia and positive AWR.|
1602937|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.4833|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus versus Urethral Meatus in patients with vulvodynia and positive AWR.|
1602938|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's line versus Vestibule in patients with vulvodynia and positive AWR?||||||0.3037|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's line versus Vestibule in patients with vulvodynia and positive AWR.|
1603034|NCT02732145|2945116|Equivalence|Question: Is there a difference in the incidence of slow AWR between patients from different groups and positive AWR?||||||0.001|||||||Chi-squared|||Parameter: The difference in the incidence of slow AWR occurrence between patients from different groups and positive AWR.|
1602939|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR?||||||0.1918|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR.|
1602940|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.0085|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvodynia and positive AWR.|
1602941|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.0148|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvodynia and positive AWR.|
1602942|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvodynia and positive AWR?||||||0.072|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvodynia and positive AWR.|
1602943|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvodynia and positive AWR?||||||0.4164|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvodynia and positive AWR.|
1602944|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR?||||||0.5987|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvodynia and positive AWR.|
1602945|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvodynia and positive AWR?||||||0.3594|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvodynia and positive AWR.|
1602946|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvodynia and positive AWR?||||||0.4833|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvodynia and positive AWR.|
1602947|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvodynia and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvodynia and positive AWR.|
1602948|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with vulvodynia and positive AWR?||||||0.072|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's Line in patients with vulvodynia and positive AWR.|
1602949|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.036|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening versus Vestibule in patients with vulvar dermatosis and positive AWR.|
1602950|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.0927|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants versus Vestibule in patients with vulvar dermatosis and positive AWR.|
1602951|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.1822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.|
1602952|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.1822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Urethral Sulcus versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.|
1602953|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.4742|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Vestibule in patients with vulvar dermatosis and positive AWR.|
1602954|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR?||||||0.1627|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR.|
1602955|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.3301|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.|
1602956|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.3301|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.|
1602957|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR?||||||0.7161|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR.|
1602958|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvar dermatosis and positive AWR?||||||0.5943|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Vestibule in patients with vulvar dermatosis and positive AWR.|
1602959|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR?||||||0.1627|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Bartholin's Gland Opening in patients with vulvar dermatosis and positive AWR.|
1602960|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR?||||||0.2478|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hymenal Remnants in patients with vulvar dermatosis and positive AWR.|
1602961|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvar dermatosis and positive AWR?||||||0.2478|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Meatus in patients with vulvar dermatosis and positive AWR.|
1602962|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR?||||||0.8569|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Urethral Sulcus in patients with vulvar dermatosis and positive AWR.|
1602963|NCT02732145|2945111|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris versus Hart's line in patients with vulvar dermatosis and positive AWR?||||||0.8545|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris versus Hart's line in patients with vulvar dermatosis and positive AWR.|
1602964|NCT02732145|2945111|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of the Vestibule among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Vestibule among patients from different groups, with positive AWR.|
1602965|NCT02732145|2945111|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of Bartholin's Gland Opening among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Bartholin's Gland Opening among patients from different groups, with positive AWR.|
1602966|NCT02732145|2945111|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of Hymenal Remnants among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Hymenal Remnants among patients from different groups, with positive AWR.|
1602967|NCT02732145|2945111|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Meatus among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Meatus among patients from different groups, with positive AWR.|
1602968|NCT02732145|2945111|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of the Urethral Sulcus among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Urethral Sulcus among patients from different groups, with positive AWR.|
1602969|NCT02732145|2945111|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of Hart's Line among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Hart's Line among patients from different groups, with positive AWR.|
1602970|NCT02732145|2945111|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of the Clitoris among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Clitoris among patients from different groups, with positive AWR.|
1602971|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with normal vulva and positive AWR.|
1602972|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with normal vulva and positive AWR.|
1602973|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with normal vulva and positive AWR?||||||0.0534|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with normal vulva and positive AWR.|
1602974|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with normal vulva and positive AWR.|
1602975|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with normal vulva and positive AWR?||||||0.0534|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with normal vulva and positive AWR.|
1602976|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with normal vulva and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with normal vulva and positive AWR.|
1603691|NCT02722330|2945690|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||250 Hz|
1602977|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.|
1602978|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.|
1602979|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with impaired vulvar skin and positive AWR?||||||0.4505|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with impaired vulvar skin and positive AWR.|
1602980|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with impaired vulvar skin and positive AWR.|
1602981|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with impaired vulvar skin and positive AWR.|
1602982|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with impaired vulvar skin and positive AWR?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with impaired vulvar skin and positive AWR.|
1602983|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Labia Minora versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Minora versus Posterior Commissure in patients with vulvodynia and positive AWR.|
1602984|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Posterior Commissure in patients with vulvodynia and positive AWR.|
1602985|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Interlabial Sulci versus Labia Minora in patients with vulvodynia and positive AWR?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Interlabial Sulci versus Labia Minora in patients with vulvodynia and positive AWR.|
1602986|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvodynia and positive AWR.|
1602987|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvodynia and positive AWR.|
1602988|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvodynia and positive AWR?||||||1e-05|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvodynia and positive AWR.|
1602989|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0.0389|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.|
1602990|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0.0389|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.|
1602991|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with vulvar dermatosis and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci versus Labia Minora in patients with vulvar dermatosis and positive AWR.|
1602992|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvar dermatosis and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Posterior Commissure in patients with vulvar dermatosis and positive AWR.|
1602993|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvar dermatosis and positive AWR?||||||0.0318|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Labia Minora in patients with vulvar dermatosis and positive AWR.|
1602994|NCT02732145|2945112|Superiority|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvar dermatosis and positive AWR?||||||0.0318|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure versus Interlabial Sulci in patients with vulvar dermatosis and positive AWR.|
1602995|NCT02732145|2945112|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of the Posterior Commissure among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Posterior Commissure among patients from different groups, with positive AWR.|
1602996|NCT02732145|2945112|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of the Labia Minora among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Labia Minora among patients from different groups, with positive AWR.|
1602997|NCT02732145|2945112|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of the Interlabial Sulci among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Interlabial Sulci among patients from different groups, with positive AWR.|
1602998|NCT02732145|2945112|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of the Anterior Commissure among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Anterior Commissure among patients from different groups, with positive AWR.|
1602999|NCT02732145|2945113|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with impaired vulvar skin and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with impaired vulvar skin and positive AWR.|
1603000|NCT02732145|2945113|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with impaired vulvar skin and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with impaired vulvar skin and positive AWR.|
1603001|NCT02732145|2945113|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with impaired vulvar skin and positive AWR?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with impaired vulvar skin and positive AWR.|
1603002|NCT02732145|2945113|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvodynia and positive AWR?||||||0.0936|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvodynia and positive AWR.|
1603003|NCT02732145|2945113|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvodynia and positive AWR?||||||0.0011|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvodynia and positive AWR.|
1603004|NCT02732145|2945113|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvodynia and positive AWR?||||||0.0429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvodynia and positive AWR.|
1603005|NCT02732145|2945113|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvar dermatosis and positive AWR?||||||0.0635|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora versus Perineum in patients with vulvar dermatosis and positive AWR.|
1603006|NCT02732145|2945113|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvar dermatosis and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Perineum in patients with vulvar dermatosis and positive AWR.|
1603007|NCT02732145|2945113|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvar dermatosis and positive AWR?||||||0.0128|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis versus Labia Majora in patients with vulvar dermatosis and positive AWR.|
1603008|NCT02732145|2945113|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of the Perineum among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of the Perineum among patients from different groups, with positive AWR.|
1603009|NCT02732145|2945113|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of Labia Majora among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Labia Majora among patients from different groups, with positive AWR.|
1603010|NCT02732145|2945113|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of Mons Pubis among patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Mons Pubis among patients from different groups, with positive AWR.|
1603011|NCT02732145|2945114|Superiority|Question: Is there a difference in the velocity of the aceto-whitening occurrence between patients with normal vulva and vulvodynia, with positive AWR?||||||0|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between patients with normal vulva and vulvodynia, with positive AWR.|
1603012|NCT02732145|2945114|Superiority|Question: Is there a difference in the velocity of the aceto-whitening occurrence between the patients with normal vulva and impaired vulvar skin, with positive AWR?||||||0.0006|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between the patients with normal vulva and impaired vulvar skin, with positive AWR.|
1603013|NCT02732145|2945114|Superiority|Question: Is there a difference in the velocity of the aceto-whitening occurrence between patients with vulvar dermatosis and vulvodynia, with positive AWR?||||||0.0231|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the velocity of the aceto-whitening occurrence between patients with vulvar dermatosis and vulvodynia, with positive AWR.|
1603035|NCT02732145|2945116|Equivalence|Question: Is there a difference in the incidence of coarse AWR between patients from different groups and positive AWR?||||||0.0071|||||||Chi-squared|||Parameter: The difference in the incidence of coarse AWR between patients from different groups and positive AWR.|
1603014|NCT02732145|2945114|Equivalence|Question: Is there a difference in the velocity of the aceto-whitening occurrence among patients with positive AWR from different groups?||||||0.0004|||||||Kruskal-Wallis|||Parameter: The difference in the velocity of the aceto-whitening occurrence among patients with positive AWR from different groups.|
1603015|NCT02732145|2945115|Equivalence|Question: Is there a difference in the velocity of the aceto-whitening occurrence among patients from different groups, in which the AWR was positive?||||||0.0003|||||||ANOVA|||Parameter: The difference in the velocity of the aceto-whitening occurrence (positive AWR) among patients from different groups, in which the AWR was positive.|
1603016|NCT02732145|2945116|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with normal vulva and positive AWR?||||||0.4975|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with normal vulva and positive AWR.|
1603017|NCT02732145|2945116|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with normal vulva and positive AWR.|
1603018|NCT02732145|2945116|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with normal vulva and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with normal vulva and positive AWR.|
1603019|NCT02732145|2945116|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0.5822|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR.|
1603020|NCT02732145|2945116|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with impaired vulvar skin and positive AWR.|
1603021|NCT02732145|2945116|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with impaired vulvar skin and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with impaired vulvar skin and positive AWR.|
1603022|NCT02732145|2945116|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvodynia and positive AWR?||||||0.1918|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvodynia and positive AWR.|
1603023|NCT02732145|2945116|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvodynia and positive AWR.|
1603024|NCT02732145|2945116|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvodynia and positive AWR?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvodynia and positive AWR.|
1603025|NCT02732145|2945116|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.0124|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Middle versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR.|
1603026|NCT02732145|2945116|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.429|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Inner Vulvar Ring in patients with vulvar dermatosis and positive AWR.|
1603027|NCT02732145|2945116|Superiority|Question: Is there a difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvar dermatosis and positive AWR?||||||0.0856|||||||t-test proportion|||Parameter: The difference in the incidence of aceto-whitening of Outer versus Middle Vulvar Ring in patients with vulvar dermatosis and positive AWR.|
1603028|NCT02732145|2945116|Equivalence|"Question: Is there a difference in the incidence of Ring sign between the patients from different groups and positive AWR?"||||||0|||||||Chi-squared|||"Parameter: The difference in the incidence of Ring sign, aceto-whitening of all structures of the Inner Vulvar Ring, between the patients from different groups and positive AWR."|
1603029|NCT02732145|2945116|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of Inner Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Inner Vulvar Ring between the patients from different groups and positive AWR.|
1603030|NCT02732145|2945116|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of Middle Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Middle Vulvar Ring between the patients from different groups and positive AWR.|
1603031|NCT02732145|2945116|Equivalence|Question: Is there a difference in the incidence of aceto-whitening of Outer Vulvar Ring between the patients from different groups and positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening of Outer Vulvar Ring between the patients from different groups and positive AWR.|
1603032|NCT02732145|2945116|Equivalence|Question: Is there a difference in the incidence of sharply bordered AWR between patients from different groups and positive AWR?||||||0.0032|||||||Chi-squared|||Parameter: The difference in the incidence of sharply bordered AWR between patients from different groups and positive AWR.|
1603033|NCT02732145|2945116|Equivalence|Question: Is there a difference in the incidence of provoked erythema among patients from different groups and positive AWR?||||||0.0036|||||||Chi-squared|||Parameter: The difference in the incidence of provoked erythema among patients from different groups and positive AWR.|
1603036|NCT02732145|2945116|Equivalence|Question: Is there a difference in the incidence of aceto-whitening between patients from different groups, with positive AWR?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of aceto-whitening between patients from different groups, with positive AWR.|
1603037|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.0295|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Vestibule in patients with vulvar dermatosis.|
1603038|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.|
1603039|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0149|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hymenal Remnants in patients with vulvar dermatosis.|
1603040|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Meatus in patients with vulvar dermatosis?||||||0.0295|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Meatus in patients with vulvar dermatosis.|
1603041|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Sulcus in patients with vulvar dermatosis?||||||0.3067|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of the Urethral Sulcus in patients with vulvar dermatosis.|
1603042|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hart's Line in patients with vulvar dermatosis?||||||0.0211|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Clitoris versus specific lesions of Hart's Line in patients with vulvar dermatosis.|
1603043|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0006|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.|
1603044|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0251|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.|
1603045|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin.|
1603046|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin.|
1603047|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin?||||||0.0001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin.|
1603048|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin?||||||0.0013|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with impaired vulvar skin.|
1603049|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with impaired vulvar skin.|
1603050|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin?||||||0.0002|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with impaired vulvar skin.|
1603051|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with impaired vulvar skin?||||||0.0091|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with impaired vulvar skin.|
1603052|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with impaired vulvar skin.|
1603053|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with impaired vulvar skin.|
1603054|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvodynia?||||||0.0021|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603055|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of Bartholin's Gland Opening in patients with vulvodynia?||||||0.0423|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of Bartholin's Gland Opening in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603056|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvodynia?||||||0.0131|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603057|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvodynia?||||||0.0007|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603058|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with vulvodynia?||||||0.0048|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of the Urethral Meatus in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603059|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvodynia?||||||0.0007|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603060|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with vulvodynia?||||||0.0048|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of the Urethral Meatus in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603061|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Bartholin's Gland Opening versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Bartholin's Gland Opening versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.|
1603062|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.0012|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hymenal Remnants versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.|
1603063|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0.004|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Meatus versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.|
1603064|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.|
1603065|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0208|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Urethral Sulcus versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis.|
1603066|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis?||||||0.0007|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Bartholin's Gland Opening in patients with vulvar dermatosis.|
1603067|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis?||||||0.0208|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Hart's Line versus non-specific lesions of Hymenal Remnants in patients with vulvar dermatosis.|
1603068|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Vestibule in patients with vulvar dermatosis.|
1603069|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with vulvar dermatosis?||||||0.001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of the Urethral Sulcus in patients with vulvar dermatosis.|
1603070|NCT02732145|2945117|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with vulvar dermatosis?||||||0.001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Clitoris versus non-specific lesions of Hart's Line in patients with vulvar dermatosis.|
1603071|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of papillae of the Vestibule among patients from different groups?||||||0.0053|||||||Chi-squared|||"Parameter: The incidence of papillae of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603072|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of papillae of Hart's Line among patients from different groups?||||||0.0004|||||||Chi-squared|||"Parameter: The incidence of papillae of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603073|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of punctuation of the Vestibule among patients from different groups?||||||0.0198|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy.. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603074|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of punctuation of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of punctuation of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603075|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of ischemia of the Vestibule among patients from different groups?||||||0.0019|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603076|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of ischemia of the Urethral Meatus among patients from different groups?||||||0.0038|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603077|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of ischemia of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603078|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of ischemia of the Clitoris among patients from different groups?||||||0.0021|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603079|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of smoothness of the Urethral Meatus among patients from different groups?||||||0.0235|||||||Chi-squared|||"Parameter: The incidence of smoothness of Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603080|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of smoothness of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603081|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of smoothness of the Clitoris among patients from different groups?||||||0.0023|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603139|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvar dermatosis.|
1603082|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of erythema of the Vestibule among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603083|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of erythema of Bartholin's Gland Opening among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Bartholin's Gland Opening in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603084|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of erythema of Hymenal Remnants among patients from different groups?||||||0.0001|||||||Chi-squared|||"Parameter: The incidence of erythema of Hymenal Remnants in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603085|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of erythema of the Urethral Meatus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Urethral Meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603086|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of erythema of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603087|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of erythema of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603088|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of erythema of the Clitoris among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603089|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of non-specific lesions of the Vestibule among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Vestibule in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603090|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of non-specific lesions of Bartholin's Gland Opening among the patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Bartholin's Gland Opening in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603091|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of non-specific lesions of Hymenal Remnants among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Hymenal Remnants in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603092|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Meatus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Urethral meatus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603093|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of non-specific lesions of the Urethral Sulcus among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Urethral Sulcus in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of the vulvodynia."|
1603094|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of non-specific lesions of Hart's Line among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Hart's Line in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603140|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvar dermatosis?||||||0.0014|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvar dermatosis.|
1603095|NCT02732145|2945117|Equivalence|Question: Is there a difference in the incidence of non-specific lesions of the Clitoris among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Clitoris in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603096|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of specific lesion of Labia Minora versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.8848|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Labia Minora versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.|
1603097|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of specific lesion of Interlabial Sulci versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.1681|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Interlabial Sulci versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.|
1603098|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of specific lesion of Interlabial Sulci versus specific lesions of Labia Minora in patients with vulvar dermatosis?||||||0.4577|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Interlabial Sulci versus specific lesions of Labia Minora in patients with vulvar dermatosis.|
1603099|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.6676|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of the Posterior Commissure in patients with vulvar dermatosis.|
1603100|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of Labia Minora in patients with vulvar dermatosis?||||||0.7758|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of Labia Minora in patients with vulvar dermatosis.|
1603101|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of specific lesion of the Anterior Commissure versus specific lesions of Interlabial Sulci in patients with vulvar dermatosis?||||||0.3053|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Anterior Commissure versus specific lesions of Interlabial Sulci in patients with vulvar dermatosis.|
1603102|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.|
1603103|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0.0003|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.|
1603104|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with impaired vulvar skin.|
1603105|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with impaired vulvar skin?||||||0.0006|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with impaired vulvar skin.|
1603106|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with impaired vulvar skin.|
1603107|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603108|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Interlabial Sulci versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603109|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603588|NCT02729038|2945379|Other||Ratio of geometric LS means|1.507|||||2-Sided|90.0|0.902|2.519|||||AUC (0-inf) for participants with normal renal function Vs participants with moderate renal function has been presented.||
1603110|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Labia Minora in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603111|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603112|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.028|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Labia Minora versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis.|
1603113|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis?||||||0.0001|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of the Posterior Commissure in patients with vulvar dermatosis.|
1603114|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvar dermatosis?||||||0.0158|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Anterior Commissure versus non-specific lesions of Interlabial Sulci in patients with vulvar dermatosis.|
1603115|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of smoothness of the Posterior Commissure among patients from different groups?||||||0.0205|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603116|NCT02732145|2945118|Superiority|Question: Is there a difference in the frequency of smoothness of Labia Minora among patients from different groups?||||||0.0024|||||||Chi-squared|||"Parameter: The frequency of smoothness of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603117|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of smoothness of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603118|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of smoothness of the Anterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603119|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of fissures of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603120|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of fissures of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603121|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of erythema of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603122|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of erythema of Labia Minora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603123|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of erythema of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603124|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of erythema of the Anterior Commissure among patients from different groups?||||||0.0199|||||||Chi-squared|||"Parameter: The incidence of erythema of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q- Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603125|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Posterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Posterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy.. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603126|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Labia Minora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Labia Minora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603127|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Interlabial Sulci among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Interlabial Sulci in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603128|NCT02732145|2945118|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Anterior Commissure among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Anterior Commissure in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603129|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of specific lesions of Labia Majora versus specific lesions of the Perineum in patients with vulvar dermatosis?||||||0.0854|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Labia Majora versus specific lesions of the Perineum in patients with vulvar dermatosis.|
1603130|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of specific lesions of Mons Pubis versus specific lesions of the Perineum in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Mons Pubis versus specific lesions of the Perineum in patients with vulvar dermatosis.|
1603131|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of specific lesions of Mons Pubis versus specific lesions of Labia Majora in patients with vulvar dermatosis?||||||0.0002|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of Mons Pubis versus specific lesions of Labia Majora in patients with vulvar dermatosis.|
1603132|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with impaired vulvar skin?||||||0.1352|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesion of Labia Majora versus non-specific lesions of the Perineum in patients with impaired vulvar skin.|
1603133|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with impaired vulvar skin?||||||0.1352|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with impaired vulvar skin.|
1603134|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with impaired vulvar skin?||||||1|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with impaired vulvar skin.|
1603135|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvodynia?||||||0.0587|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603136|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvodynia?||||||0.0008|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of the Perineum in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603137|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvodynia?||||||0.0898|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of Mons Pubis versus non-specific lesions of Labia Majora in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603138|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora versus non-specific lesions of the Perineum in patients with vulvar dermatosis?||||||0.0414|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesion of Labia Majora versus non-specific lesions of the Perineum in patients with vulvar dermatosis.|
1603623|NCT02724111|2945587|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1603141|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of rhagades of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603142|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of rhagades of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603143|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of rhagades of Mons Pubis among patients from different groups?||||||0.0016|||||||Chi-squared|||"Parameter: The incidence of rhagades of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603144|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of excoriations of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603145|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of excoriations of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603146|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of excoriations of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603147|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of erythema of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603148|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of erythema of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603149|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of erythema of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of Mons Pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603150|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Perineum among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Perineum in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603151|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Labia Majora among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Labia Majora in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603152|NCT02732145|2945119|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Mons Pubis among patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of Mons pubis in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant for the diagnosis of the vulvodynia."|
1603153|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of specific lesions of the Middle versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.0058|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Middle versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.|
1603154|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of specific lesions of the Outer versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Outer versus specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.|
1603204|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of abnormal PAP smear among patients from different groups?||||||0.0018|||||||Chi-squared|||Parameter: The difference in the incidence of abnormal PAP smear among patients from different groups.|
1603155|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of specific lesions of the Outer versus specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis?||||||0.1133|||||||t-test proportion|||Parameter: The difference in the incidence of specific lesions of the Outer versus specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis.|
1603156|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin?||||||0.1456|||||||t-test proportion|||Parameter: The incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin.|
1603157|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Outer versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with impaired vulvar skin.|
1603158|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Outer versus non-specific lesions of the Middle Vulvar Ring in patients with impaired vulvar skin?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with impaired vulvar skin.|
1603159|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia?||||||0.2203|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603160|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603161|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia?||||||0|||||||t-test proportion|||"Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvodynia.~The diagnosis of vulvodynia was based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection, Q-Tip) following Friedrich's criteria. Vulvoscopic lesions were not relevant to the diagnosis of vulvodynia."|
1603162|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of non-specific lesions of Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.7273|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of Middle versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.|
1603163|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis?||||||0.0319|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Inner Vulvar Ring in patients with vulvar dermatosis.|
1603164|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis?||||||0.0697|||||||t-test proportion|||Parameter: The difference in the incidence of non-specific lesions of the Outer versus non-specific lesions of the Middle Vulvar Ring in patients with vulvar dermatosis.|
1603165|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of papillae of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of papillae of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603166|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of punctuation of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Typ), evaluated with Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603167|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of punctuation of the Middle Vulvar Ring between patients within different groups?||||||0.0043|||||||Chi-squared|||"Parameter: The incidence of punctuation of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603168|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of ischemia of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603169|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of ischemia of the Middle Vulvar Ring between patients from different groups?||||||0.0632|||||||Chi-squared|||"Parameter: The incidence of ischemia of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603170|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of smoothness of the Inner Vulvar Ring between patients within different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603171|NCT02732145|2945120|Superiority|Question: Is there a difference in the frequency of smoothness of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of smoothness of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603172|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of rhagades of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of rhagades of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603173|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of fissures the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of fissures of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603174|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of excoriations of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of excoriations of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603175|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of erythema of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603176|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of erythema of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603177|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of erythema of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of erythema of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603178|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Inner Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Inner Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603179|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Middle Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Middle Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603180|NCT02732145|2945120|Superiority|Question: Is there a difference in the incidence of non-specific lesions of the Outer Vulvar Ring between patients from different groups?||||||0|||||||Chi-squared|||"Parameter: The incidence of non-specific lesions of the Outer Vulvar Ring in patients classified into four groups based on anamnestic data (ISSVD Questionnaire) and clinical examination (Inspection and Q-Tip), which were examined by the Three Rings Vulvoscopy. Vulvoscopic lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia."|
1603181|NCT02732145|2945121|Superiority|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 12h in patients with vulvar dermatosis versus normal vulva?||||||0.072|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 12h in patients with vulvar dermatosis and normal vulva.|
1603182|NCT02732145|2945121|Superiority|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 10h in patients with vulvar dermatosis versus normal vulva?||||||0.0579|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 10h in patients with vulvar dermatosis and normal vulva.|
1603183|NCT02732145|2945121|Superiority|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 8h in patients with vulvar dermatosis and normal vulva?||||||0.008|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 8h in patients with vulvar dermatosis and normal vulva.|
1603205|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of HPV infection among patients from different groups, who were tested for HPV?||||||0.2128|||||||Chi-squared|||Parameter: The difference in the incidence of HPV infection among patients from different groups, who were tested for HPV.|
1603184|NCT02732145|2945121|Superiority|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 6h in patients with vulvar dermatosis versus normal vulva?||||||0.0037|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 6h in patients with vulvar dermatosis and normal vulva.|
1603185|NCT02732145|2945121|Superiority|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 4h in patients with vulvar dermatosis versus normal vulva?||||||0.0134|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 4h in patients with vulvar dermatosis and normal vulva.|
1603186|NCT02732145|2945121|Superiority|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 2h in patients with vulvar dermatosis versus normal vulva?||||||0.0289|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 2h in patients with vulvar dermatosis versus normal vulva.|
1603187|NCT02732145|2945121|Superiority|Question: Is there a difference in the incidence of a positive Cotton-Swab test of the vulva in patients with vulvar dermatosis versus normal vulva?||||||0.0009|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test of the vulva in patients with vulvar dermatosis versus normal vulva.|
1603188|NCT02732145|2945121|Equivalence|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 12h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 12h among patients from different groups.|
1603189|NCT02732145|2945121|Equivalence|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 10h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 10h among patients from different groups.|
1603190|NCT02732145|2945121|Equivalence|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 8h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 8h among patients from different groups.|
1603191|NCT02732145|2945121|Equivalence|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 6h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 6h among patients from different groups.|
1603192|NCT02732145|2945121|Equivalence|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 4h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 4h among patients from different groups.|
1603193|NCT02732145|2945121|Equivalence|Question: Is there a difference in the incidence of a positive Cotton-Swab test at the point marked as 2h among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test at the point marked as 2h among patients from different groups.|
1603194|NCT02732145|2945121|Equivalence|Question: Is there a difference in the incidence of a positive Cotton-Swab test of the vulva among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of a positive Cotton-Swab test of the vulva among patients from different groups.|
1603195|NCT02732145|2945122|Superiority|Question: Is there a difference in the frequency of previous systemic treatment with antidepressant between the patients with vulvar dermatosis and vulvodynia?||||||0.0962|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antidepressant among patients with vulvar dermatosis and vulvodynia.|
1603196|NCT02732145|2945122|Superiority|Question: Is there a difference in the frequency of previous local treatment with corticosteroids between the patients with vulvar dermatosis and vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with corticoids among patients with vulvar dermatosis and vulvodynia.|
1603197|NCT02732145|2945122|Superiority|Question: Is there a difference in the frequency of previous systemic treatment with antibiotics between the patients with vulvar dermatosis and vulvodynia?||||||0.2131|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antibiotics among patients with vulvar dermatosis and vulvodynia.|
1603198|NCT02732145|2945122|Superiority|Question: Is there a difference in the frequency of previous local treatment with antibiotics between the patients with vulvar dermatosis and vulvodynia?||||||0.467|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with antibiotics among patients with vulvar dermatosis and vulvodynia.|
1603199|NCT02732145|2945122|Superiority|Question: Is there a difference in the frequency of previous systemic treatment with antifungals between the patients with vulvar dermatosis and vulvodynia?||||||0.6468|||||||Chi-squared|||Parameter: The difference in the frequency of previous systemic treatment with antifungals among patients with vulvar dermatosis and vulvodynia.|
1603200|NCT02732145|2945122|Superiority|Question: Is there a difference in the frequency of previous local treatment with antifungals between the patients with vulvar dermatosis and vulvodynia?||||||0.038|||||||Chi-squared|||Parameter: The difference in the frequency of previous local treatment with antifungals among patients with vulvar dermatosis and vulvodynia.|
1603201|NCT02732145|2945122|Superiority|Question: Is there a difference in the frequency of any previous treatment between patients with vulvar dermatosis and vulvodynia?||||||0.1583|||||||Chi-squared|||Parameter: The difference in the frequency of any previous treatment between patients with vulvar dermatosis and vulvodynia.|
1603202|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of conization or LETZ among patients from different groups?||||||0.2452|||||||Chi-squared|||Parameter: The difference in the incidence of conization or LETZ among patients from different groups.|
1603203|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of genital warts among patients from different groups?||||||0.2524|||||||Chi-squared|||Parameter: The difference in the incidence of genital warts among patients from different groups.|
1603624|NCT02724111|2945588|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1603692|NCT02722330|2945691|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||6000 Hz|
1603206|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of recurrent attacks of sinusitis among patients from different groups?||||||0.0105|||||||Chi-squared|||Parameter: The difference in the incidence of recurrent attacks of sinusitis among patients from different groups.|
1603207|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of drug allergy among patients from different groups?||||||0.2756|||||||Chi-squared|||Parameter: The difference in the incidence of drug allergy among patients from different groups.|
1603208|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of thyroid disease among patients from different groups?||||||0.0011|||||||Chi-squared|||Parameter: The difference in the incidence of thyroid disease among patients from different groups.|
1603209|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of genital herpes among patients from different groups?||||||0.9323|||||||Chi-squared|||Parameter: The difference in the incidence of genital herpes among patients from different groups.|
1603210|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of hypertension among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of hypertension among patients from different groups.|
1603211|NCT02732145|2945123|Equivalence|"Question: Is there a difference in the incidence of D-D-D Triad among patients from different groups?"||||||0.0028|||||||Chi-squared|||"Parameter: The difference in the difference in the incidence of D-D-D Triad (Dysmenorrhoea-Dyspareunia-Dysuria) among patients from different groups."|
1603212|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of endometriosis among patients from different groups?||||||0.3127|||||||Chi-squared|||Parameter: The difference in the incidence of endometriosis among patients from different groups.|
1603213|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of unintended weight loss among patients from different groups?||||||0.1764|||||||Chi-squared|||Parameter: The difference in the incidence of unintended weight loss among patients from different groups.|
1603214|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of pelvic pain among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of pelvic pain among patients from different groups.|
1603215|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of sleep disorders among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of sleep disorders among patients from different groups.|
1603216|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of energy loss among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of energy loss among patients from different groups.|
1603217|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of fibromyalgia among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of fibromyalgia among patients from different groups.|
1603218|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of lumbar pain among patients from different groups?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of lumbar pain among patients from different groups.|
1603219|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of chronic fatigue among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of chronic fatigue among patients from different groups.|
1603220|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of a frequent headache among patients from different groups?||||||0.3957|||||||Chi-squared|||Parameter: The difference in the incidence of a frequent headache among patients from different groups.|
1603221|NCT02732145|2945123|Equivalence|Question: Is there a difference in the incidence of any associated symptom or disease among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of any associated symptom or disease among patients from different groups.|
1603222|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of the irritable colon between patients from different groups?||||||0.006|||||||Chi-squared|||Parameter: The difference in the incidence of the irritable colon between patients from different groups.|
1603223|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of frequent diarrhea between patients from different groups?||||||0.5253|||||||Chi-squared|||Parameter: The difference in the incidence of frequent diarrhea between patients from different groups.|
1603224|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of intermittent diarrhea between patients from different groups?||||||0.0192|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent diarrhea between patients from different groups.|
1603225|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of diarrhea between patients from different groups?||||||0.0092|||||||Chi-squared|||Parameter: The difference in the incidence of diarrhea between patients from different groups.|
1603226|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of frequent constipation between patients from different groups?||||||0.4155|||||||Chi-squared|||Parameter: The difference in the incidence of frequent constipation between patients from different groups.|
1603227|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of intermittent constipation between patients from different groups?||||||0.1485|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent constipation between patients from different groups.|
1603228|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of constipation between patients from different groups?||||||0.0379|||||||Chi-squared|||Parameter: The difference in the incidence of constipation between patients from different groups.|
1603229|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of recurrent cystitis between patients from different groups?||||||0.0539|||||||Chi-squared|||Parameter: The difference in the incidence of recurrent cystitis between patients from different groups.|
1603230|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of frequent nocturia between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of frequent nocturia between patients from different groups.|
1603681|NCT02722330|2945688|Superiority or Other|||||||0.0024|||||||Wilcoxon Signed Rank test||||
1603231|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of intermittent nocturia between patients from different groups?||||||0.2315|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent nocturia between patients from different groups.|
1603232|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of nocturia between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of nocturia between patients from different groups.|
1603233|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of frequent urgency between patients from different groups?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of frequent urgency between patients from different groups.|
1603234|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of intermittent urgency between patients from different groups?||||||0.083|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent urgency between patients from different groups.|
1603235|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of urgency between patients from different groups?||||||0.0065|||||||Chi-squared|||Parameter: The difference in the incidence of urgency between patients from different groups.|
1603236|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of frequent difficulties at starting urination between patients from different groups?||||||0.5673|||||||Chi-squared|||Parameter: The difference in the incidence of frequent difficulties at starting urination between patients from different groups.|
1603237|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of intermittent difficulties at starting urination between patients from different groups?||||||0.0013|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent difficulties at starting urination between patients from different groups.|
1603238|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of difficulties at starting urination between patients from different groups?||||||0.0015|||||||Chi-squared|||Parameter: The difference in the incidence of difficulties at starting urination between patients from different groups.|
1603239|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of frequent urinary incontinence between patients from different groups?||||||0.0003|||||||Chi-squared|||Parameter: The difference in the incidence of frequent urinary incontinence between patients from different groups.|
1603240|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of intermittent urinary incontinence between patients from different groups?||||||0.1859|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent urinary incontinence between patients from different groups.|
1603241|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of urinary incontinence between patients from different groups?||||||0.001|||||||Chi-squared|||Parameter: The difference in the incidence of urinary incontinence between patients from different groups.|
1603242|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of frequent dysuria between patients from different groups?||||||0.0003|||||||Chi-squared|||Parameter: The difference in the incidence of frequent dysuria between patients from different groups.|
1603243|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of intermittent dysuria between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of intermittent dysuria between patients from different groups.|
1603244|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of dysuria between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of dysuria between patients from different groups.|
1603245|NCT02732145|2945124|Equivalence|Question: Is there a difference in the incidence of problems associated with urination and defecation between patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of problems associated with urination and defecation between patients from different groups.|
1603246|NCT02732145|2945125|Superiority|Question: Is there a difference in the frequency of worsening of vulvar complaints during urination after sexual intercourse in symptomatic patients, who are sexually active?||||||0.1019|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar complaints during urination after sexual intercourse in symptomatic patients, who are sexually active.|
1603247|NCT02732145|2945125|Superiority|Question: Is there a difference in the frequency of worsening of vulvar discomfort during urination?||||||0.1546|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort during urination.|
1603248|NCT02732145|2945125|Superiority|Question: Is there a difference in the frequency of worsening of vulvar discomfort between two menstrual bleeding in symptomatic patients of reproductive age?||||||0.5307|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort between two menstrual bleeding in symptomatic patients of reproductive age.|
1603249|NCT02732145|2945125|Superiority|Question: Is there a difference in the frequency of worsening of vulvar discomfort after menstrual bleeding in symptomatic patients of reproductive age?||||||0.6148|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort after menstrual bleeding in symptomatic patients of reproductive age.|
1603250|NCT02732145|2945125|Superiority|Question: Is there a difference in the frequency of worsening of vulvar discomfort during menstrual bleeding in symptomatic patients of reproductive age?||||||0.5722|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort during menstrual bleeding in symptomatic patients of reproductive age.|
1603251|NCT02732145|2945125|Superiority|Question: Is there a difference in the frequency of worsening of vulvar discomfort before starting menstrual bleeding in symptomatic patients of reproductive age?||||||0.0179|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort before starting menstrual bleeding in symptomatic patients of reproductive age.|
1603252|NCT02732145|2945125|Superiority|Question: Is there a difference in the frequency of worsening of vulvar discomfort depending on the menstrual cycle in symptomatic patients of reproductive age?||||||0.1082|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort depending on the menstrual cycle in symptomatic patients of reproductive age.|
1603682|NCT02722330|2945689|Superiority or Other|||||||0.002|||||||Wilcoxon Signed Rank test||||
1603683|NCT02722330|2945690|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||6000 Hz|
1603253|NCT02732145|2945125|Superiority|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to wearing of tight clothes in symptomatic patients, who wear tight clothes?||||||0.4754|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to wearing of tight clothes in symptomatic patients, who wear tight clothes.|
1603254|NCT02732145|2945125|Superiority|Question: Is there a difference in the frequency of wearing tight clothes among patients with vulvar dermatosis and vulvodynia?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the frequency of wearing tight clothes among patients with vulvar dermatosis and vulvodynia.|
1603255|NCT02732145|2945125|Superiority|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to the cycling in symptomatic patients, who ride a bicycle?||||||0.2877|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to the cycling in symptomatic patients, who ride a bicycle.|
1603256|NCT02732145|2945125|Superiority|Question: Is there a difference in the frequency of cycling among patients with vulvodynia and vulvar dermatosis?||||||0.0002|||||||Chi-squared|||Parameter: The difference in the frequency of cycling among patients with vulvodynia and vulvar dermatosis.|
1603257|NCT02732145|2945125|Superiority|Question: Is there a difference in the frequency of worsening of vulvar discomfort due to the use of vaginal tampon in symptomatic patients, who use vaginal tampons?||||||0.6552|||||||Chi-squared|||Parameter: The difference in the frequency of worsening of vulvar discomfort due to the use of vaginal tampon in symptomatic patients, who use vaginal tampons.|
1603258|NCT02732145|2945125|Superiority|Question: Is there a difference in the frequency of use of vaginal tampon among patients with vulvodynia and vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of use of vaginal tampon among patients with vulvodynia and vulvar dermatosis.|
1603259|NCT02732145|2945126|Equivalence|Question: Is there a difference in the frequency of vulvar discomfort aggravated after sexual intercourse in patients with vulvodynia and vulvar dermatosis?||||||0.0025|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort aggravated after sexual intercourse in patients with vulvodynia and vulvar dermatosis.|
1603260|NCT02732145|2945126|Equivalence|Question: Is there a difference in the frequency of vulvar discomfort aggravated through sexual intercourse in patients with vulvodynia and vulvar dermatosis?||||||0.7068|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort aggravated through sexual intercourse in patients with vulvodynia and vulvar dermatosis.|
1603261|NCT02732145|2945126|Equivalence|Question: Is there a difference in the frequency of vulvar discomfort provoked through the penetration in patients with vulvodynia and vulvar dermatosis?||||||0.0347|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort provoked through the penetration in patients with vulvodynia and vulvar dermatosis.|
1603262|NCT02732145|2945126|Equivalence|Question: Is there a difference in the incidence of the frequency of vulvar discomfort provoked through the intercourse in patients with vulvodynia and vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of vulvar discomfort provoked through the intercourse in patients with vulvodynia and vulvar dermatosis.|
1603263|NCT02732145|2945127|Equivalence|Parameter: The difference in the degree of dyspareunia (Marinoff Index) among sexually active patients with vulvodynia or vulvar dermatosis who had dyspareunia.||||||0.2999|||||||Chi-squared|||Parameter: The difference in the degree of dyspareunia (Marinoff Index) among sexually active patients with vulvodynia or vulvar dermatosis who had dyspareunia.|
1603264|NCT02732145|2945127|Equivalence|Question: Is there a difference in the frequency of dyspareunia among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of dyspareunia among patients from different groups.|
1603265|NCT02732145|2945128|Equivalence|Question: Is there a difference in the frequency of sexual inactivity due to dyspareunia and lack of a sexual partner among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the frequency of sexual inactivity due to dyspareunia and lack of a sexual partner among patients from different groups.|
1603266|NCT02732145|2945128|Equivalence|Question: Is there a difference in the frequency of dyspareunia as a cause of sexual inactivity among patients from different groups?||||||0.0006|||||||Chi-squared|||Parameter: The difference in the frequency of dyspareunia as a cause of sexual inactivity among patients from different groups.|
1603267|NCT02732145|2945128|Equivalence|Question: Is there a difference in the sexual activity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the sexual activity among patients from different groups.|
1603268|NCT02732145|2945129|Equivalence|Question: Is there a difference in the duration of vulvar complaints for more than six months among patients with vulvar dermatosis and vulvodynia?||||||0.7241|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than six months among patients with vulvar dermatosis or vulvodynia.|
1603269|NCT02732145|2945129|Equivalence|Question: Is there a difference in the duration of vulvar complaints for more than 12 months among patients with vulvar dermatosis and vulvodynia?||||||0.7299|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than 12 months among patients with vulvar dermatosis or vulvodynia.|
1603270|NCT02732145|2945129|Equivalence|Question: Is there a difference in the duration of vulvar complaints for more than 24 months among patients with vulvar dermatosis and vulvodynia?||||||0.4038|||||||Chi-squared|||Parameter: The difference in the duration of vulvar complaints for more than 24 months among patients with vulvar dermatosis or vulvodynia.|
1603271|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stabbing versus paper-cuts pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.073|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus paper-cuts pain in patients with vulvodynia who had sharp vulvar pain.|
1603272|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stabbing versus knife-like pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.3094|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus knife-like pain in patients with vulvodynia who had sharp vulvar pain.|
1603317|NCT02732145|2945129|Equivalence|Question: Is there a difference in the incidence of the paper-cuts pain of the vulva among the patients with vulvar discomfort?||||||0.043|||||||Chi-squared|||Parameter: The difference in the incidence of the paper-cuts pain of the vulva among patients with vulvar discomfort.|
1603273|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar sticking versus stabbing in the patients with vulvodynia who had sharp vulvar pain?||||||0.7978|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus stabbing in patients with vulvodynia who had sharp vulvar pain.|
1603274|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar sticking versus paper-cuts pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.0412|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus paper-cuts pain in patients with vulvodynia who had sharp vulvar pain.|
1603275|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar sticking versus knife-like pain in the patients with vulvodynia who had sharp vulvar pain?||||||0.2041|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus knife-like pain in patients with vulvodynia who had sharp vulvar pain.|
1603276|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar aching versus the feeling of inflammation in the patients with vulvodynia?||||||0.5277|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus the feeling of inflammation in patients with vulvodynia.|
1603277|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar aching versus irritation in the patients with vulvodynia?||||||0.6364|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus irritation in patients with vulvodynia.|
1603278|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar aching versus soreness in the patients with vulvodynia?||||||0.1508|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus soreness in patients with vulvodynia.|
1603279|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar aching versus burning in the patients with vulvodynia?||||||0.2155|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus burning in patients with vulvodynia.|
1603280|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar itching versus aching in the patients with vulvodynia?||||||0.003|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus aching in patients with vulvodynia.|
1603281|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar itching versus the feeling of inflammation in the patients with vulvodynia?||||||0.0188|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus the feeling of inflammation in patients with vulvodynia.|
1603282|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar itching versus irritation in the patients with vulvodynia?||||||0.0123|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus irritation in patients with vulvodynia.|
1603283|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar itching versus soreness in the patients with vulvodynia?||||||0.1201|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus soreness in patients with vulvodynia.|
1603284|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar itching versus burning in the patients with vulvodynia?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus burning in patients with vulvodynia.|
1603285|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stinging versus aching in the patients with vulvodynia?||||||0.0005|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus aching in patients with vulvodynia.|
1603286|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stinging versus the feeling of inflammation in the patients with vulvodynia?||||||0.0037|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus the feeling of inflammation in patients with vulvodynia.|
1603287|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stinging versus itching in the patients with vulvodynia?||||||0.5675|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus itching in patients with vulvodynia.|
1603288|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stinging versus irritation in the patients with vulvodynia?||||||0.0023|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus irritation in patients with vulvodynia.|
1603289|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stinging versus soreness in the patients with vulvodynia?||||||0.0344|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus soreness in patients with vulvodynia.|
1603290|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stinging versus burning in the patients with vulvodynia?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus burning in patients with vulvodynia.|
1603291|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stabbing versus paper-cuts pain in the patients with vulvar dermatosis who had sharp pain?||||||0.2059|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus paper-cuts pain in patients with vulvar dermatosis who had sharp vulvar pain.|
1603292|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stabbing versus knife-like pain in the patients with vulvar dermatosis who had sharp pain?||||||0.682|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stabbing versus knife-like pain in patients with vulvar dermatosis who had sharp vulvar pain.|
1603293|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar sticking versus stabbing in the patients with vulvar dermatosis who had sharp pain?||||||0.2059|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus stabbing in patients with vulvar dermatosis who had sharp vulvar pain.|
1603294|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar sticking versus paper-cuts pain in the patients with vulvar dermatosis who had sharp pain?||||||0.0143|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus paper-cuts pain in patients with vulvar dermatosis who had sharp vulvar pain.|
1603463|NCT02731820|2945152|Other|||||||0.172|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0|
1603295|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar sticking versus knife-like pain in the patients with vulvar dermatosis who had sharp pain?||||||0.0977|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar sticking versus knife-like pain in patients with vulvar dermatosis who had sharp vulvar pain.|
1603296|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar aching versus the feeling of inflammation in the patients with vulvar dermatosis?||||||0.0057|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus the feeling of inflammation in patients with vulvar dermatosis.|
1603297|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar aching versus irritation in the patients with vulvar dermatosis?||||||0.0212|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus irritation in patients with vulvar dermatosis.|
1603298|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar aching versus soreness in the patients with vulvar dermatosis?||||||0.009|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus soreness in patients with vulvar dermatosis.|
1603299|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar aching versus burning in the patients with vulvar dermatosis?||||||0.8591|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar aching versus burning in patients with vulvar dermatosis.|
1603300|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stinging versus aching in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus aching in patients with vulvar dermatosis.|
1603301|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stinging versus the feeling of inflammation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus the feeling of inflammation in patients with vulvar dermatosis.|
1603302|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stinging versus irritation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus irritation in patients with vulvar dermatosis.|
1603303|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stinging versus soreness in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus soreness in patients with vulvar dermatosis.|
1603304|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar stinging versus burning in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar stinging versus burning in patients with vulvar dermatosis.|
1603305|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar itching versus aching in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus aching in patients with vulvar dermatosis.|
1603306|NCT02732145|2945129|Superiority|||||||0||||||There was a statistically significant difference at p<0.001. Patients with vulvar dermatosis had significantly more often itching than the feeling of inflammation of the vulva.|t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus the feeling of inflammation in patients with vulvar dermatosis.|
1603307|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar itching versus irritation in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus irritation in patients with vulvar dermatosis.|
1603308|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar itching versus soreness in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus soreness in patients with vulvar dermatosis.|
1603309|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar itching versus stinging in the patients with vulvar dermatosis?||||||0.0008|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus stinging in patients with vulvar dermatosis.|
1603310|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of vulvar itching versus burning in the patients with vulvar dermatosis?||||||0|||||||t-test proportion|||Parameter: The difference in the incidence of vulvar itching versus burning in patients with vulvar dermatosis.|
1603311|NCT02732145|2945129|Equivalence|Question: Is there a difference in the association of different symptoms of the vulva among the patients with vulvar discomfort?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of association of different vulvar symptoms among patients with vulvar discomfort.|
1603312|NCT02732145|2945129|Equivalence|Question: Is there a difference in the incidence of aching of the vulva among the patients with vulvar discomfort?||||||0.0001|||||||Chi-squared|||Parameter: The difference in the incidence of aching of the vulva among patients with vulvar discomfort.|
1603313|NCT02732145|2945129|Equivalence|Question: Is there a difference in the incidence of the feeling of inflammation of the vulva among the patients with vulvar discomfort?|t-test proportion|0.0||||0.0852|2-Sided||||||Chi-squared|||Parameter: The difference in the incidence of the feeling of inflammation of the vulva among patients with vulvar discomfort.|
1603314|NCT02732145|2945129|Equivalence|Question: Is there a difference in the incidence of itching of the vulva among the patients with vulvar discomfort?||||||0.0002|||||||Chi-squared|||Parameter: The difference in the incidence of itching of the vulva among patients with vulvar discomfort.|
1603315|NCT02732145|2945129|Equivalence|Question: Is there a difference in the incidence of sticking of the vulva among the patients with vulvar discomfort?||||||0.0581|||||||Chi-squared|||Parameter: The difference in the incidence of sticking of the vulva among patients with vulvar discomfort.|
1603316|NCT02732145|2945129|Equivalence|Question: Is there a difference in the incidence of the stabbing of the vulva among the patients with vulvar discomfort?||||||0.0134|||||||Chi-squared|||Parameter: The difference in the incidence of the stabbing of the vulva among patients with vulvar discomfort.|
1603464|NCT02731755|2945156|Superiority|||||||0.7|||||||Mixed Models Analysis||||
1603465|NCT02731755|2945158|Superiority|||||||0.9|||||||Mixed Models Analysis||||
1603318|NCT02732145|2945129|Equivalence|Question: Is there a difference in the incidence of the knife-like pain in the vulva among the patients with vulvar discomfort?||||||0.0457|||||||Chi-squared|||Parameter: The difference in the incidence of the knife-like pain in the vulva among patients with vulvar discomfort.|
1603319|NCT02732145|2945129|Equivalence|Question: Is there a difference in the incidence of irritation of the vulva among the patients with vulvar discomfort?||||||0.0423|||||||Chi-squared|||Parameter: The difference in the incidence of irritation of the vulva among patients with vulvar discomfort.|
1603320|NCT02732145|2945129|Equivalence|Question: Is there a difference in the incidence of vulvar soreness among patients with vulvar discomfort?||||||0.0076|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar soreness among patients with vulvar discomfort.|
1603321|NCT02732145|2945129|Equivalence|Question: Is there a difference in the incidence of vulvar stinging among patients with vulvar discomfort?||||||0.8456|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar stinging among patients with vulvar discomfort.|
1603322|NCT02732145|2945129|Equivalence|Question: Is there a difference in the incidence of vulvar burning among patients with vulvar discomfort?||||||0.0147|||||||Chi-squared|||Parameter: The difference in the incidence of vulvar burning among patients with vulvar discomfort.|
1603323|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of the dull pain versus the sharp pain of the vulva in the patients with vulvodynia?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain versus the sharp pain of the vulva in patients with vulvodynia.|
1603324|NCT02732145|2945129|Superiority|Question: Is there a difference in the incidence of the dull pain versus the sharp pain of the vulva in the patients with vulvar dermatosis?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain versus the sharp pain of the vulva in patients with vulvar dermatosis.|
1603325|NCT02732145|2945129|Equivalence|Question: Is there a difference in the incidence of symptoms of the sharp pain of the vulva among patients with vulvar discomfort?||||||0.0007|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the sharp pain in the vulva (stabbing, sticking, knife-like pain, paper-cuts pain) among patients with vulvar discomfort.|
1603326|NCT02732145|2945129|Equivalence|Question: Is there a difference in the incidence of symptoms of the dull pain of the vulva among patients with vulvar discomfort?||||||0.3158|||||||Chi-squared|||Parameter: The difference in the incidence of symptoms of the dull pain of the vulva (burning, stinging, soreness, irritation, itching, inflammation, aching) among patients with vulvar discomfort.|
1603327|NCT02732145|2945130|Equivalence|Question: Is there a difference in the using of contraception among patients from different groups?||||||0.1323|||||||Chi-squared|||Parameter: The difference in the using of contraception among patients from different groups.|
1603328|NCT02732145|2945130|Equivalence|Question: Is there a difference in the number of abortions among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the number of abortions among patients from different groups.|
1603329|NCT02732145|2945130|Equivalence|Question: Is there a difference in the multiparity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the multiparity among patients from different groups.|
1603330|NCT02732145|2945130|Equivalence|Question: Is there a difference in the nulliparity among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the nulliparity among patients from different groups.|
1603331|NCT02732145|2945130|Equivalence|Question: Is there a difference in marital status among patients from different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of marital status among patients from different groups.|
1603332|NCT02732145|2945130|Equivalence|Question: Is there a difference in the incidence of patients educated equally or less than 12 years among different groups?||||||0.018|||||||Chi-squared|||Parameter: The difference in the incidence of patients educated equally or less than 12 years among different groups.|
1603333|NCT02732145|2945130|Equivalence|Question: Is there a difference in the incidence of domicile country (Croatia) as a country of birth among patients from different groups.||||||0.3708|||||||Chi-squared|||Parameter: The difference in the incidence of domicile country (Croatia) as a country of birth among patients from different groups.|
1603334|NCT02732145|2945130|Equivalence|Question: Is there a difference in the incidence of menopausal patients among different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of menopausal patients among different groups.|
1603335|NCT02732145|2945130|Equivalence|Question: Is there a difference in the incidence of patients older than 65 years in different groups?||||||0|||||||Chi-squared|||Parameter: The difference in the incidence of patients older than 65 years between different groups.|
1603336|NCT02732145|2945131|Equivalence|Is there a difference in the body mass index of patients from different groups.||||||0|||||||ANOVA|||The difference in the body mass index of patients from different groups.|
1603337|NCT02732145|2945132|Equivalence|Is there a difference in the height of patients from different groups.||||||0.0557|||||||ANOVA|||The difference in the height of patients from different groups.|
1603338|NCT02732145|2945133|Equivalence|Is there a difference in the weight of patients from different groups?||||||0|||||||ANOVA|||The difference in the weight of patients from different groups.|
1603339|NCT02732145|2945134|Equivalence|Question: Is there a difference in the age of patients from different groups?||||||0|||||||ANOVA|||Parameter: The difference in the age of patients from different groups.|
1603340|NCT02732145|2945135|Superiority|"Question: Is there a difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0016|||||||t-test proportion|||"Parameter: The difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603341|NCT02732145|2945135|Superiority|"Question: Is there a difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9724|||||||t-test proportion|||"Parameter: The difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603342|NCT02732145|2945135|Superiority|"Question: Is there a difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6339|||||||t-test proportion|||"Parameter: The difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603343|NCT02732145|2945135|Superiority|"Question: Is there a difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.1165|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603344|NCT02732145|2945135|Superiority|"Question: Is there a difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8161|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603345|NCT02732145|2945135|Superiority|"Question: Is there a difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9723|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603346|NCT02732145|2945135|Superiority|"Question: Is there a difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0064|||||||t-test proportion|||"Parameter: The difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603347|NCT02732145|2945135|Superiority|"Question: Is there a difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8224|||||||t-test proportion|||"Parameter: The difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603348|NCT02732145|2945135|Superiority|"Question: Is there a difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6541|||||||t-test proportion|||"Parameter: The difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603349|NCT02732145|2945135|Superiority|"Question: Is there a difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.0019|||||||t-test proportion|||"Parameter: The difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603350|NCT02732145|2945135|Superiority|"Question: Is there a difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8338|||||||t-test proportion|||"Parameter: The difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603351|NCT02732145|2945135|Superiority|"Question: Is there a difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.253|||||||t-test proportion|||"Parameter: The difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603352|NCT02732145|2945136|Superiority|"Question: Is there a difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of P result (specific lesions) in any of the Three Vulvar Rings (P-#-#; P-P-; P-P-P; P-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603353|NCT02732145|2945136|Superiority|"Question: Is there a difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.7912|||||||t-test proportion|||"Parameter: The difference in the frequency of S result (non-specific lesions) in any of the Three Vulvar Rings (S-#-#; S-S-#; S-S-S; S-N-S etc.) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603354|NCT02732145|2945136|Superiority|"Question: Is there a difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of N-N-N result (no lesions) in any of the Three Vulvar Rings in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603355|NCT02732145|2945136|Superiority|"Question: Is there a difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-P result (specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603356|NCT02732145|2945136|Superiority|"Question: Is there a difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.6152|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-S result (non-specific lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603357|NCT02732145|2945136|Superiority|"Question: Is there a difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.3912|||||||t-test proportion|||"Parameter: The difference in the frequency of #-#-N result (no lesions) of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603358|NCT02732145|2945136|Superiority|"Question: Is there a difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.7992|||||||t-test proportion|||"Parameter: The difference in the frequency of #-P-# result (specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603359|NCT02732145|2945136|Superiority|"Question: Is there a difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8634|||||||t-test proportion|||"Parameter: The difference in the frequency of #-S-# result (non-specific lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603360|NCT02732145|2945136|Superiority|"Question: Is there a difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||1|||||||t-test proportion|||"Parameter: The difference in the frequency of #-N-# result (no lesions) of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603361|NCT02732145|2945136|Superiority|"Question: Is there a difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9786|||||||t-test proportion|||"Parameter: The difference in the frequency of P-#-# result (specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603362|NCT02732145|2945136|Superiority|"Question: Is there a difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8618|||||||t-test proportion|||"Parameter: The difference in the frequency of S-#-# result (non-specific lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603363|NCT02732145|2945136|Superiority|"Question: Is there a difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.9286|||||||t-test proportion|||"Parameter: The difference in the frequency of N-#-# result (no lesions) of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603364|NCT02732145|2945137|Superiority|"Question: Is there a difference in the diagnostic accuracy of the N-S-P Scheme as an outcome measure of the diagnostic value of Three Rings Vulvoscopy, and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the diagnostic accuracy between TRIV using the N-S-P Scheme and histopathology for detection of vulvar dermatosis."|
1603365|NCT02732145|2945137|Other|"Question: Determination of negative predictive value of the N-S-P Scheme for detection of vulvar dermatosis in comparison to the histopathology results."|NPV (2x2 Table)|1.0|||||2-Sided|95.0|1.0|1.0|||||"Negative predictive value of the N-S-P Scheme for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Negative predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."|
1603366|NCT02732145|2945137|Other|"Question: Determination of positive predictive value of the N-S-P Scheme for detection of vulvar dermatosis in comparison to the histopathology results."|PPV (2x2 Table)|0.878|||||2-Sided|95.0|0.227|1.0|||||"Positive predictive value of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.8780 (Range: 0.2270 - 1.0000)."|"Parameter: Positive predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."|
1603367|NCT02732145|2945137|Other|"Question: Determination of diagnostic accuracy of the N-S-P Scheme as a measure of the diagnostic value of the Three Rings Vulvoscopy, in relation to the histopathological diagnosis of vulvar dermatosis."|Diagnostic Accuracy (2x2 Table)|0.9695|||||2-Sided|95.0|0.6313|1.0|||||"The Diagnostic accuracy of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.9695 (Range: 0.6313 – 1.0000)."|"Parameter: Diagnostic accuracy of Three Rings Vulvoscopy for detection of vulvar dermatosis."|
1603368|NCT02732145|2945137|Other|"Question: Determination of specificity of the N-S-P Scheme as a measure of the specificity of Three Rings Vulvoscopy, in comparison to the histopathological diagnosis of vulvar dermatosis."|Specificity (2x2 Table)|0.9609|||||2-Sided|95.0|0.5794|1.0|||||"The Specificity of the N-S-P Scheme for Detection of Vulvar Dermatosis was 0.9609 (Range: 0.5794 – 1.0000)."|"Parameter: Specificity of Three Rings Vulvoscopy for detection of vulvar dermatosis."|
1603369|NCT02732145|2945137|Other|"Question: Determination of sensitivity of the N-S-P Scheme as a measure of the sensitivity of Three Rings Vulvoscopy, in comparison to the histopathological diagnosis of vulvar dermatosis."|Sensitivity (2x2 Table)|1.0|||||2-Sided|95.0|1.0|1.0|||||"The Sensitivity of the N-S-P Scheme for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 – 1.0000)."|"Parameter: Sensitivity of Three Rings Vulvoscopy for detection of vulvar dermatosis."|
1603370|NCT02732145|2945138|Equivalence|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.4409|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603371|NCT02732145|2945138|Equivalence|Question: Is there a difference in the score for specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy)?||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar lesions specific for dermatosis (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy).|
1603372|NCT02732145|2945138|Equivalence|Question: Is there a difference in the score for non-specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8987|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603373|NCT02732145|2945138|Equivalence|Question: Is there a difference in the score for the specificity of vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3621|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603466|NCT02731755|2945159|Superiority|||||||0.02|||||||Mixed Models Analysis|||Ach - AUC|
1603467|NCT02731755|2945159|Superiority|||||||0.007|||||||Mixed Models Analysis|||SNP-IAUC|
1603374|NCT02732145|2945138|Equivalence|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9753|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603375|NCT02732145|2945138|Equivalence|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.6412|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603376|NCT02732145|2945138|Equivalence|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.2058|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603377|NCT02732145|2945138|Equivalence|Question: Is there a difference in the score for any lesion in any vulvar ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5124|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603378|NCT02732145|2945138|Equivalence|Question: Is there a difference in the score for the Cotton-Swab test in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9839|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603379|NCT02732145|2945138|Equivalence|Question: Is there a difference in the score for Marinoff Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9248|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603380|NCT02732145|2945138|Equivalence|Question: Is there a difference in the score for vulvar complaints in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5403|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (median) in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603381|NCT02732145|2945139|Equivalence|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8144|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603382|NCT02732145|2945139|Equivalence|Question: Is there a difference in the score for specific vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for specific vulvar lesions (median) with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603383|NCT02732145|2945139|Equivalence|Question: Is there a difference in the score for non-specific vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8666|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603384|NCT02732145|2945139|Equivalence|Question: Is there a difference in the score for the specificity of vulvar lesions (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8666|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603385|NCT02732145|2945139|Equivalence|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3335|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603386|NCT02732145|2945139|Equivalence|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603387|NCT02732145|2945139|Equivalence|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8866|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603388|NCT02732145|2945139|Equivalence|Question: Is there a difference in the score for any lesion in any vulvar ring (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.4913|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603389|NCT02732145|2945139|Equivalence|Question: Is there a difference in the score for the Cotton-Swab test (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9155|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603390|NCT02732145|2945139|Equivalence|Question: Is there a difference in the score for Marinoff Index (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9629|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603468|NCT02731755|2945159|Superiority|||||||0.04|||||||Mixed Models Analysis|||Ach-iAUC|
1603469|NCT02731755|2945160|Superiority|||||||0.5|||||||Mixed Models Analysis|||Between time points and treatments, calculated p value|
1603391|NCT02732145|2945139|Equivalence|Question: Is there a difference in the score for vulvar complaints (median) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (median) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603392|NCT02732145|2945141|Equivalence|"Question: Is there a difference in the overall sum of points for the Vulvoscopy Index (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?"||||||0.8472|||||||Wilcoxon (Mann-Whitney)|||"Parameter: The difference in the overall sum of points for the Vulvoscopy Index (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology."|
1603393|NCT02732145|2945141|Equivalence|Question: Is there a difference in the score for specific vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for specific vulvar lesions (mean) with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603394|NCT02732145|2945141|Equivalence|Question: Is there a difference in the score for non-specific vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8673|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for non-specific vulvar lesions (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603395|NCT02732145|2945141|Equivalence|Question: Is there a difference in the score for the specificity of vulvar lesions (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8673|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the specificity of vulvar lesions (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603396|NCT02732145|2945141|Equivalence|Question: Is there a difference in the score for any vulvar lesion of the Inner Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3351|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Inner Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603397|NCT02732145|2945141|Equivalence|Question: Is there a difference in the score for any vulvar lesion of the Middle Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Middle Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603398|NCT02732145|2945141|Equivalence|Question: Is there a difference in the score for any vulvar lesion of the Outer Vulvar Ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8852|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any vulvar lesion of the Outer Vulvar Ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603399|NCT02732145|2945141|Equivalence|Question: Is there a difference in the score for any lesion in any vulvar ring (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.7055|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for any lesion in any vulvar ring (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603400|NCT02732145|2945141|Equivalence|Question: Is there a difference in the score for the Cotton-Swab test (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9686|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for the Cotton-Swab test (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603401|NCT02732145|2945141|Equivalence|Question: Is there a difference in the score for Marinoff Index (mean) among patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9899|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for Marinoff Index (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603402|NCT02732145|2945141|Equivalence|Question: Is there a difference in the score for vulvar complaints (mean) among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||Wilcoxon (Mann-Whitney)|||Parameter: The difference in the score for vulvar complaints (mean) in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603403|NCT02732145|2945142|Superiority|Question: Is there a difference in the frequency of specific vulvar lesions among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy)?||||||0.0017|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar lesions specific for dermatosis in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology (first biopsy).|
1603404|NCT02732145|2945142|Superiority|Question: Is there a difference in the frequency of non-specific vulvar lesions among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8986|||||||t-test proportion|||Parameter: The difference in the frequency of non-specific vulvar lesions in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603405|NCT02732145|2945142|Superiority|Question: Is there a difference in the frequency of any vulvar lesion of the Inner Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9753|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Inner Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603406|NCT02732145|2945142|Superiority|Question: Is there a difference in the frequency of any vulvar lesion of the Middle Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.6409|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Middle Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603407|NCT02732145|2945142|Superiority|Question: Is there a difference in the frequency of any vulvar lesion of the Outer Vulvar Ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.2054|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Outer Vulvar Ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603684|NCT02722330|2945690|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||4000 Hz|
1603685|NCT02722330|2945690|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||3000 Hz|
1603408|NCT02732145|2945142|Superiority|Question: Is there a difference in the frequency of any lesion in any vulvar ring among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.7537|||||||t|||Parameter: The difference in the frequency of any lesion in any vulvar ring in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603409|NCT02732145|2945142|Superiority|Question: Is there a difference in the frequency of the positive Cotton-Swab test among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9839|||||||t-test proportion|||Parameter: The difference in the frequency of the positive Cotton-Swab test in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603410|NCT02732145|2945142|Superiority|Question: Is there a difference in the frequency of positive Marinoff Index among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9248|||||||t-test proportion|||Parameter: The difference in the frequency of positive Marinoff Index in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603411|NCT02732145|2945142|Superiority|Question: Is there a difference in the frequency of vulvar complaints among the patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.5399|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar complaints in patients with absent vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603412|NCT02732145|2945143|Superiority|Question: Is there a difference in the frequency of specific vulvar lesions among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar lesions specific for dermatosis in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603413|NCT02732145|2945143|Superiority|Question: Is there a difference in the frequency of non-specific vulvar lesions among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.8662|||||||t-test proportion|||Parameter: The difference in the frequency of non-specific vulvar lesions in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603414|NCT02732145|2945143|Superiority|Question: Is there a difference in the frequency of any vulvar lesion of the Inner Vulvar Ring among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.3319|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Inner Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603415|NCT02732145|2945143|Superiority|Question: Is there a difference in the frequency of any vulvar lesion of the Middle Vulvar Ring among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Middle Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603416|NCT02732145|2945143|Superiority|Question: Is there a difference in the frequency of any vulvar lesion of the Outer Vulvar Ring among the patients with vulvar dermatosis diagnosed with vulvoscopy and histopathology?||||||0.8862|||||||t-test proportion|||Parameter: The difference in the frequency of any vulvar lesion of the Outer Vulvar Ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603417|NCT02732145|2945143|Superiority|Question: Is there a difference in the frequency of any lesion in any vulvar ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of any lesion in any vulvar ring in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603418|NCT02732145|2945143|Superiority|Question: Is there a difference in the frequency of the positive Cotton-Swab test among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9152|||||||t-test proportion|||Parameter: The difference in the frequency of the positive Cotton-Swab test in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603419|NCT02732145|2945143|Superiority|Question: Is there a difference in the frequency of positive Marinoff Index among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||0.9628|||||||t-test proportion|||Parameter: The difference in the frequency of positive Marinoff Index in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603420|NCT02732145|2945143|Superiority|Question: Is there a difference in the frequency of vulvar complaints among the patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology?||||||1|||||||t-test proportion|||Parameter: The difference in the frequency of vulvar complaints in patients with vulvar dermatosis diagnosed by vulvoscopy and histopathology.|
1603421|NCT02732145|2945144|Superiority|"Question: Is there a difference in the diagnostic accuracy of the Vulvoscopy Index as an outcome measure of the diagnostic value of Three Rings Vulvoscopy, and histopathology?"||||||0.6108|||||||t-test proportion|||"Parameter: The difference in the diagnostic accuracy between TRIV using the Vulvoscopy Index and histopathology for detection of vulvar dermatosis."|
1603422|NCT02732145|2945144|Other|"Question: Determination of negative predictive value of the Vulvoscopy index for detection of vulvar dermatosis in comparison to the histopathology results."|NPV (2x2 Table)|1.0|||||2-Sided|95.0|1.0|1.0|||||"Negative predictive value of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 1.0000 (Range: 1.0000 - 1.0000)."|"Parameter: Negative predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."|
1603423|NCT02732145|2945144|Superiority|"Question: Determination of positive predictive value of the Vulvoscopy index for detection of vulvar dermatosis in comparison to the histopathology results."|PPV (2x2 Table)|0.878|||||2-Sided|95.0|0.227|1.0|||||"Positive predictive value of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.8780 (Range: 0.2270 - 1.0000)."|"Parameter: Positive predictive value of Three Rings Vulvoscopy for detection of vulvar dermatosis."|
1603424|NCT02732145|2945144|Other|"Question: Determination of diagnostic accuracy of the Vulvoscopy index as a measure of the diagnostic value of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Diagnostic Accuracy (2x2 Table)|0.9695|||||2-Sided|95.0|0.6313|1.0|||||"The Diagnostic accuracy of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.9695 (Range: 0.6313 – 1.0000)"|"Parameter: Diagnostic accuracy of Three Rings Vulvoscopy for detection of vulvar dermatosis."|
1603470|NCT02731690|2945165|Superiority|||||||0.0489||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48|
1603425|NCT02732145|2945144|Other|"Question: Determination of specificity of the Vulvoscopy index as a measure of the specificity of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Specificity (2x2 Table)|0.9609|||||2-Sided|95.0|0.5794|1.0|||||"The Specificity of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 0.9609 (Range: 0.5794 – 1.0000)"|"Parameter: Specificity of Three Rings Vulvoscopy for detection of vulvar dermatosis."|
1603426|NCT02732145|2945144|Other|"Question: Determination of sensitivity of the Vulvoscopy Index as a measure of the sensitivity of Three Rings Vulvoscopy in comparison to the histopathological diagnosis of vulvar dermatosis."|Sensitivity (2x2 Table)|1.0|||||2-Sided|95.0|1.0|1.0|||||"The Sensitivity of the Vulvoscopy Index for Detection of Vulvar Dermatosis was 1.000 (Range: 1.0000 – 1.0000)."|"Parameter: Sensitivity of Three Rings Vulvoscopy for detection of vulvar dermatosis."|
1603427|NCT02731833|2945148|Superiority or Other||Least Square (LS) Mean Difference|-0.4|||<|0.0001|2-Sided|95.0|-0.505|-0.3|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response, treatment as factor and baseline Schiff sensitivity score as a covariate.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|Statistical analyses was conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.|
1603428|NCT02731820|2945149|Other|||||||0.555|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6|
1603429|NCT02731820|2945149|Other|||||||0.434|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3|
1603430|NCT02731820|2945149|Other|||||||0.458|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0|
1603431|NCT02731820|2945149|Other|||||||0.0007|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3|
1603432|NCT02731820|2945149|Other||||||<|0.0001|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0|
1603433|NCT02731820|2945149|Other||||||<|0.002|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0|
1603434|NCT02731820|2945149|Other||||||<|0.008|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3|
1603435|NCT02731820|2945149|Other||||||<|0.0004|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0|
1603436|NCT02731820|2945149|Other||||||<|0.094|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0|
1603437|NCT02731820|2945150|Other|||||||0.466|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6|
1603438|NCT02731820|2945150|Other|||||||0.371|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3|
1603439|NCT02731820|2945150|Other|||||||0.551|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0|
1603440|NCT02731820|2945150|Other|||||||0.139|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3|
1603441|NCT02731820|2945150|Other|||||||0.176|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0|
1603442|NCT02731820|2945150|Other|||||||0.37|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0|
1603443|NCT02731820|2945150|Other|||||||0.234|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3|
1603444|NCT02731820|2945150|Other|||||||0.191|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0|
1603445|NCT02731820|2945150|Other|||||||0.213|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0|
1603446|NCT02731820|2945151|Other|||||||0.172|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6|
1603447|NCT02731820|2945151|Other|||||||0.859|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3|
1603448|NCT02731820|2945151|Other|||||||0.343|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0|
1603449|NCT02731820|2945151|Other|||||||0.017|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3|
1603450|NCT02731820|2945151|Other|||||||0.04|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0|
1603451|NCT02731820|2945151|Other|||||||0.886|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0|
1603452|NCT02731820|2945151|Other|||||||0.377|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3|
1603453|NCT02731820|2945151|Other|||||||0.798|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0|
1603454|NCT02731820|2945151|Other|||||||0.954|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T3 vs T0|
1603455|NCT02731820|2945152|Other|||||||0.869|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T6|
1603456|NCT02731820|2945152|Other|||||||0.446|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T3|
1603457|NCT02731820|2945152|Other|||||||0.967|||||||t-test, 2 sided|||Independent comparison (unpaired analysis) between Potassium Citrate and Placebo at T0|
1603458|NCT02731820|2945152|Other|||||||0.139|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T3|
1603459|NCT02731820|2945152|Other|||||||0.006|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T6 vs T0|
1603460|NCT02731820|2945152|Other|||||||0.002|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Placebo: T3 vs T0|
1603461|NCT02731820|2945152|Other|||||||0.053|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T3|
1603462|NCT02731820|2945152|Other|||||||0.027|||||||t-test, 1 sided|||Paired analysis within the group to evaluate the effect of Potassium Citrate: T6 vs T0|
1603471|NCT02731690|2945165|Superiority|||||||0.0086||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36|
1603472|NCT02731690|2945165|Superiority|||||||0.0073||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24|
1603473|NCT02731690|2945165|Superiority|||||||0.0872||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12|
1603474|NCT02731690|2945166|Superiority|||||||0.7635||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48|
1603475|NCT02731690|2945166|Superiority|Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.||||||0.2316||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36|
1603476|NCT02731690|2945166|Superiority|Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.||||||0.6403||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24|
1603477|NCT02731690|2945166|Superiority|||||||0.0752||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12|
1603478|NCT02731690|2945167|Superiority|||||||0.197||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48|
1603479|NCT02731690|2945167|Superiority|||||||0.018||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36|
1603480|NCT02731690|2945167|Superiority|||||||0.2213||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24|
1603481|NCT02731690|2945167|Superiority|||||||0.0088||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12|
1603482|NCT02731690|2945168|Superiority|||||||0.6307||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48|
1603483|NCT02731690|2945168|Superiority|||||||0.9229||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36|
1603484|NCT02731690|2945168|Superiority|||||||0.6201||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24|
1603485|NCT02731690|2945168|Superiority|||||||0.1615||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12|
1603486|NCT02731690|2945169|Superiority|||||||0.0661||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48|
1603487|NCT02731690|2945169|Superiority|||||||0.1047||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36|
1603488|NCT02731690|2945169|Superiority|||||||0.0465||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24|
1603489|NCT02731690|2945169|Superiority|||||||0.581||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12|
1603490|NCT02731690|2945170|Superiority|||||||0.5678||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48|
1603491|NCT02731690|2945170|Superiority|||||||0.0459||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36|
1603492|NCT02731690|2945170|Superiority|||||||0.0533||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24|
1603493|NCT02731690|2945170|Superiority|||||||0.0568||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12|
1603494|NCT02731690|2945171|Superiority|||||||0.0642||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48|
1603495|NCT02731690|2945171|Superiority|||||||0.3428||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36|
1603496|NCT02731690|2945171|Superiority|||||||0.1697||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24|
1603497|NCT02731690|2945171|Superiority|||||||0.0715||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12|
1603498|NCT02731690|2945172|Superiority|||||||0.0706||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 48|
1603499|NCT02731690|2945172|Superiority|||||||0.1189||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 36|
1603500|NCT02731690|2945172|Superiority|||||||0.1646||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 24|
1603501|NCT02731690|2945172|Superiority|||||||0.5303||||||Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|GEE model|||Week 12|
1603502|NCT02731638|2945185|Superiority||Coefficient|0.5||||0.75|2-Sided|95.0|-2.6|3.6|||Regression, Linear||Positive coefficients of the logMAR value indicate worsened visual acuity||
1603503|NCT02731638|2945185|Superiority||Coefficient|1.6||||0.25|2-Sided|95.0|-1.2|4.4|||Regression, Linear||Positive coefficients of the logMAR value indicated worsened visual acuity||
1603504|NCT02731638|2945186|Superiority||Odds Ratio (OR)|1.82||||0.26|2-Sided|95.0|0.65|5.23|||Regression, Logistic|Bias-corrected logistic regression, accounting for baseline culture status|||
1603505|NCT02731313|2945207|Non-Inferiority or Equivalence|Null hypothesis (H0): kappa coefficient = 0.90||||||0.7436|||||||Kappa-test p-value, 2 sided|||Rationale for the determination of the number of samples:The following hypotheses were considered: two-sided risk alpha = 5%, power (1 - beta) = 90%, a success rate (rate of positive HER-2 status) = 17%, null hypothesis (H0): kappa coefficient = 0.90. 359 samples would allow determining a first estimate of the 0.90 coefficient of correlation kappa. The total number of samples, which had to be included in this study was 395, considering a 10% rate of non-evaluable samples.|
1603506|NCT02731300|2945208|Superiority or Other||||||<|0.05||||||the final Week 4 values compared between active tDCS and sham tDCS groups|ANOVA|||the final Week 4 values compared between active tDCS and sham tDCS groups|
1603507|NCT02731300|2945209|Superiority or Other||||||<|0.05||||||the final Week 4 values compared between active tDCS and sham tDCS groups|ANOVA|||the final Week 4 values compared between active tDCS and sham tDCS groups|
1603508|NCT02731157|2945215|Other||Mean Difference (Final Values)|0.65||||0.95|2-Sided||||||ANOVA||||
1603509|NCT02731131|2945216|Superiority or Other|||||||0.5|||||||Fisher Exact||||
1603510|NCT02731131|2945217|Superiority or Other|||||||0.3|||||||Fisher Exact||||
1603511|NCT02731131|2945218|Superiority or Other|||||||0.3|||||||Fisher Exact||||
1603512|NCT02731131|2945219|Superiority or Other|||||||0.22|||||||Fisher Exact||||
1603513|NCT02731131|2945221|Superiority or Other|||||||0.3|||||||Fisher Exact||||
1603514|NCT02730871|2945224|Other||Mean Difference (Final Values)|-13.21|Standard Error of the Mean|2.34|<|0.001|2-Sided|95.0|-17.8|-8.6|||Repeated measures model|||Percentage Change from Baseline in IOP at 11:00|
1603515|NCT02730871|2945224|Other||Mean Difference (Final Values)|-6.15|Standard Error of the Mean|2.567|<|0.018|2-Sided|95.0|-11.2|-1.1|||Repeated measures model|||Percentage Change from Baseline in IOP at 09:00|
1603516|NCT02730871|2945225|Other||Mean Difference (Final Values)|-2.85|Standard Error of the Mean|0.506|<|0.001|2-Sided|95.0|-3.9|-1.9|||Repeated measures model|||Change from Baseline in IOP at 11:00|
1603517|NCT02730871|2945225|Other||Mean Difference (Final Values)|-1.33|Standard Error of the Mean|0.576|<|0.022|2-Sided|95.0|-2.5|-0.2|||Repeated measures model|||Change from Baseline in IOP at 9:00|
1603518|NCT02730871|2945226|Other||Mean Difference (Final Values)|-9.98|Standard Error of the Mean|1.572|<|0.001|2-Sided|95.0|-13.1|-6.9|||ANCOVA||||
1603519|NCT02730871|2945227|Other||Mean Difference (Final Values)|-2.15|Standard Error of the Mean|0.342|<|0.001|2-Sided|95.0|-2.8|-1.5|||ANCOVA||||
1603520|NCT02730871|2945228|Superiority||Mean Difference (Final Values)|-2.15|Standard Error of the Mean|0.342|<|0.001|2-Sided|95.0|-2.8|-1.5|||ANCOVA||||
1603521|NCT02730819|2945230|Superiority|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||P-values of 0.05 or lower were considered statistically significant.|
1603522|NCT02730819|2945231|Superiority|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||P-values of 0.05 or lower were considered statistically significant.|
1603538|NCT02730351|2945273|Other||Mean Difference (Final Values)|-1.75||||0.041|2-Sided|95.0|-3.42|-0.07||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values.|Mixed Models Analysis||23 hrs post-dose||
1603686|NCT02722330|2945690|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||2000 Hz|
1603523|NCT02730663|2945242|Non-Inferiority|The number and percentage of patients who achieved clinical success at the time of stent removal are presented. A one-sided 97.5% confidence interval is to be calculated to confirm the degree of non-inferiority for the reference value (96%) and the difference (Investigational device - reference value) and if the lower limit of the confidence interval is -10% or higher, the noninferiority will be considered to be confirmed.|Reference value|-0.07||||0.05|1-Sided|97.5||||A two-tail test was performed for statistics at a significance level of 0.05 unless otherwise specified.|t-test, 2 sided|||The clinical success rate at the time point of stent removal is reported 86.2% according to the approval data of the commercially available AXIOS stent submitted to the US FDA. The clinical success rates of EUS-guided transluminal drainage using a lumen-appending stent were 93.3% (29 cases), 100% (8 cases) and 100% (7 cases) respectively in the studies performed afterwards by Shah RJ (2015), Gornals JB (2012) and Moon JH (2014). The weighted average calculated for each study was about 96%.|
1603524|NCT02730455|2945251|Superiority|||||||0.049|||||||Cochran-Armitage trend test|||BI: The Cochran-Armitage trend test of a monotonically increasing dose response in proportion of excellent outcome. Dose levels are log transformed.|
1603525|NCT02730455|2945251|Superiority|||||||0.028|||||||Cochran-Armitage trend test|||"mRS: The Cochran-Armitage trend test of a monotonically increasing dose response in proportion of excellent outcome.~Dose levels are log transformed."|
1603526|NCT02730455|2945254|Superiority||Adjusted Mean Difference|-0.7||||0.542|2-Sided|95.0|-2.96|1.56|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.|
1603527|NCT02730455|2945254|Superiority||Adjusted Mean Difference|1.2||||0.315|2-Sided|95.0|-1.1|3.4|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.|
1603528|NCT02730455|2945255|Superiority||Adjusted Mean Difference|-0.6||||0.622|2-Sided|95.0|-2.89|1.73|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.|
1603529|NCT02730455|2945255|Superiority||Adjusted Mean Difference|-0.3||||0.78|2-Sided|95.0|-2.64|1.99|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.|
1603530|NCT02730455|2945256|Superiority||Adjusted Mean Difference|-6.1||||0.202|2-Sided|95.0|-15.43|3.27|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.|
1603531|NCT02730455|2945256|Superiority||Adjusted Mean Difference|-7.7||||0.106|2-Sided|95.0|-16.97|1.64|||Mixed-effects model for repeated measure|||Treatment and treatment by visit interaction were included in the model as explanatory variables. Baseline NIHSS category (score 5-15, 16-23), tPA use (yes/no), age (<60, 60-69, 70-80), thrombectomy (yes/no), region (Spain, UK/Germany, USA) and treatment window were considered as covariates. An unstructured variance-covariance matrix was used in the model.|
1603532|NCT02730455|2945257|Superiority||Odds Ratio (OR)|0.54||||0.067|2-Sided|95.0|0.28|1.04|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (<60, 60-69, 70-80), tPA use (yes/no), treatment window (<=9, >9 and <=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure.|
1603533|NCT02730455|2945257|Superiority||Odds Ratio (OR)|0.56||||0.085|2-Sided|95.0|0.29|1.08|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (<60, 60-69, 70-80), tPA use (yes/no), treatment window (<=9, >9 and <=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure.|
1603534|NCT02730455|2945258|Superiority||Odds Ratio (OR)|0.54||||0.073|2-Sided|95.0|0.28|1.06|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (<60, 60-69, 70-80), tPA use (yes/no), treatment window (<=9, >9 and <=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure|
1603535|NCT02730455|2945258|Superiority||Odds Ratio (OR)|0.67||||0.222|2-Sided|95.0|0.35|1.28|||Regression, Logistic|||The odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (<60, 60-69, 70-80), tPA use (yes/no), treatment window (<=9, >9 and <=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure|
1603536|NCT02730455|2945259|Superiority||Odds Ratio (OR)|0.57||||0.031|2-Sided|95.0|0.34|0.95|||Regression, Logistic|||Composite Measure: The global odds ratio was based on a linear logistic regression model with baseline NIHSS category (score 5-15, 16-23), age (<60, 60-69, 70-80), tPA use (yes/no), treatment window (<=9, >9 and <=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, USA) as covariates and unstructured working correlation structure|
1603537|NCT02730455|2945259|Superiority||Odds Ratio (OR)|0.64||||0.086|2-Sided|95.0|0.38|1.07|||Regression, Logistic|||Composite Measure: The global odds ratio was based on a linear logistic regression model with baseline National Institute of Health Stroke Scale (NIHSS) category (score 5-15, 16-23), age (<60, 60-69, 70-80), tissue plasminogen activator (tPA) use (yes/no), treatment window (<=9, >9 and <=24hours), thrombectomy (yes/no) and region (Spain, UK/Germany, United States of America [USA]) as covariates and unstructured working correlation structure|
1603539|NCT02730351|2945273|Other||Mean Difference (Final Values)|-0.65||||0.342|2-Sided|95.0|-2.01|0.71||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis||12 hrs post-dose||
1603540|NCT02730351|2945274|Other||Odds Ratio (OR)|1.37||||0.322|2-Sided|95.0|0.73|2.58||Repeated measures logistic regression model with parameters estimated using the Generalized Estimating Equation method|Regression, Logistic||23 hrs: modeling the odds of having FEV1 >/=95% of pre exercise FEV1 at each of the two time points.||
1603541|NCT02730351|2945274|Other||Odds Ratio (OR)|1.34||||0.266|2-Sided|95.0|0.8|2.26||Repeated measures logistic regression model with parameters estimated using the Generalized Estimating Equation method. Covariates of treatment, sex, age, treatment period, and period baseline FEV1 were included.|Regression, Logistic||12 hrs: modeling the odds of having FEV1 >/=95% of pre exercise FEV1 at each of the two time points.||
1603542|NCT02730351|2945275|Other||Mean Difference (Final Values)|-2.15||||0.051|2-Sided|95.0|-4.31|0.01||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis||||
1603543|NCT02730351|2945276|Other||Mean Difference (Final Values)|-1.69||||0.109|2-Sided|95.0|-3.76|0.39||Mixed model repeated measures analysis adjusted for fixed effects of treatment, sex, age, treatment period, smoking history, period Baseline FEV1 and the mean of the two period Baseline FEV1 values. Subject is fitted as a random effect.|Mixed Models Analysis||||
1603544|NCT02730260|2945277|Superiority or Other||Odds Ratio (OR)|1.6|||<|0.03|2-Sided||||||Regression, Logistic|||Odds ratio for PriorQuit, from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. This variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model because it was not balanced after randomization.|
1603545|NCT02730260|2945277|Superiority or Other||Odds Ratio (OR)|1.8|||<|0.03|2-Sided||||||Regression, Logistic|||Odds ratio based on the parameter estimate for the variable, IncomeAboveMedian (0=false, 1=true), from the logistic regression model representing the a priori hypothesis, which specified income, race, and intervention as independent and interacting variables, and smoking cessation at last contact as the dependent variable. An unbalanced variable, PriorQuit (0-=none in the past year, 1=at least one in the past year) was added to the a priori model.|
1603546|NCT02730260|2945277|Superiority or Other||||||<|0.41|||||||Chi-squared|||Test of the null hypothesis that directive and nondirective coaching have equal smoking cessation rates.|
1603547|NCT02730208|2945279|Other|Treatment effect outcomes are estimates.|Least Squares (LS) Mean Difference|-1.48|||||2-Sided|95.0|-7.47|4.52|||||||
1603548|NCT02729909|2945286|Superiority||Median Value of CI|-0.5||||0.004|2-Sided|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4|
1603549|NCT02729909|2945286|Superiority||Median Value of CI|-0.5|||<|0.001|2-Sided|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3|
1603550|NCT02729909|2945286|Superiority||||||<|0.072||||||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2|
1603551|NCT02729909|2945286|Superiority||Median Value of CI|-0.5|||<|0.02|2-Sided|95.0|-0.9|-0.1||Abdominal Bloating was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1|
1603552|NCT02729909|2945287|Superiority||Median Value of CI|0.5|||<|0.001|2-Sided|95.0|0.2|0.7||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4|
1603553|NCT02729909|2945287|Superiority||Median Value of CI|0.6|||<|0.001|2-Sided|95.0|0.4|0.8||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3|
1603554|NCT02729909|2945287|Superiority||Median Value of CI|0.6|||<|0.001|2-Sided|95.0|0.4|0.9||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2|
1603555|NCT02729909|2945287|Superiority||Median Value of CI|0.6|||<|0.001|2-Sided|95.0|0.4|1.0||Mean Degree of Stool Consistency was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1|
1603556|NCT02729909|2945288|Superiority||Median Value of CI|-0.3||||0.01|2-Sided|95.0|-0.5|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4|
1603557|NCT02729909|2945288|Superiority||Median Value of CI|-0.2||||0.024|2-Sided|95.0|-0.4|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3|
1603558|NCT02729909|2945288|Superiority||Median Value of CI|-0.3||||0.004|2-Sided|95.0|-0.5|-0.1||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2|
1603559|NCT02729909|2945288|Superiority||Median Value of CI|-0.4||||0.001|2-Sided|95.0|-0.6|-0.2||Average Degree of Straining was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 1|
1603560|NCT02729909|2945289|Superiority||Odds Ratio (OR)|2.08||||0.009|2-Sided|95.0|1.19|3.62||The proportion of participants with an SBM within 24 hours after first dose in Week 1 is analyzed by a Cochran-Mantel-Haenszel (CMH) test stratified by center. Centers with less participants were pooled based on geographical proximity.|Cochran-Mantel-Haenszel||||
1603687|NCT02722330|2945690|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1500 Hz|
1603561|NCT02729909|2945290|Superiority||Median Value of CI|1.0||||0.009|2-Sided|95.0|0.1|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 4|
1603562|NCT02729909|2945290|Superiority||Median Value of CI|1.5||||0.003|2-Sided|95.0|1.0|2.0||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 3|
1603563|NCT02729909|2945290|Superiority||Median Value of CI|1.0||||0.051|2-Sided|95.0|0.0|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test|||Week 2|
1603564|NCT02729909|2945291|Superiority||Median Value of confidence interval (CI)|1.0||||0.02|2-Sided|95.0|0.1|1.9||Spontaneous bowel movement was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|Van Elteren Test||||
1603565|NCT02729831|2945306|Superiority||Odds Ratio (OR)|25.7|||<|0.001|2-Sided|95.0|16.5|40.1|||Regression, Logistic|General estimating equations were used to account for clustering of patients within surgeons.||We included all 4 study groups, but the comparison group was: informed, patient centered (IPC) decision yes vs. no. We excluded those who did not provide information to calculate the IPC variable.|
1603566|NCT02729831|2945307|Superiority||Mean Difference (Net)|0.04|||<|0.001|2-Sided|95.0|0.016|0.065|||Regression, Linear|Generalized Estimating Equation accounting for clustering within surgeons. Model included treatment, sex, age, education, site and joint.||We included all 4 study groups, but the comparison group was: informed, patient centered decision yes vs. no.|
1603567|NCT02729831|2945308|Superiority||Risk Difference (RD)|18.5|||<|0.001|2-Sided|95.0|12.8|24.5|||Chi-squared|Compared patients who reported using all of the DA compared to everyone else.||Comparison groups were: patients who reported using all of the DA versus everyone else.|
1603568|NCT02729831|2945309|Superiority||Odds Ratio (OR)|1.06||||0.75|2-Sided|95.0|0.76|1.47|||Regression, Logistic|General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education.||We tested for interaction effects. Comparison groups are: Interactive decision versus Video decision aid|
1603569|NCT02729831|2945309|Superiority||Odds Ratio (OR)|1.03||||0.86|2-Sided|95.0|0.74|1.44|||Regression, Logistic|General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education.||We tested for interaction effects. Comparison groups were: MD Usual Care vs. MD Provider report.|
1603570|NCT02729831|2945310|Superiority||Mean Difference (Net)|9.0|||<|0.001|2-Sided|95.0|6.0|12.0|||Regression, Linear|||The comparison groups were: Interactive decision versus Video decision aid.|
1603571|NCT02729051|2945331|Other||Hazard Ratio (HR)|0.87|||||2-Sided|95.0|0.68|1.12|||||Analysis was performed using a Cox proportional hazards model.||
1603572|NCT02729051|2945332|Other||Mean Difference (Final Values)|0.137|Standard Error of the Mean|0.1773|||2-Sided|95.0|-0.211|0.485|||||Analysis included covariates of BDI focal score, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by BDI Focal score interactions.||
1603573|NCT02729051|2945333|Other||Odds Ratio (OR)|0.95|||||2-Sided|95.0|0.72|1.25|||||Include covariates of treatment group, stratum (number of long-acting bronchodilators/ day during the run-in: 0/1 or 2), geographical region, visit, Baseline dyspnea index (BDI) focal score, BDI focal score/ visit and treatment/ visit interactions.||
1603574|NCT02729051|2945334|Other||Least Square Mean Difference|-0.906|Standard Error of the Mean|0.8327|||2-Sided|95.0|-2.54|0.728|||||Analysis performed using a repeated measures model with covariates of Baseline SGRQ, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline.||
1603575|NCT02729051|2945335|Other||Odds Ratio (OR)|0.92|||||2-Sided|95.0|0.71|1.2|||||Analysis included covariates of treatment group, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), geographical region, visit, Baseline, Baseline by visit and treatment by visit interactions.||
1603576|NCT02729051|2945336|Non-Inferiority|If the lower bound of the two-sided 95% confidence interval around the (FF/UMEC/VI versus FF/VI+UMEC) treatment difference is above -50 milliliter (mL) then FF/UMEC/VI was to be considered non-inferior to FF/VI+UMEC.|Mean Difference (Final Values)|0.018|Standard Error of the Mean|0.0161|||2-Sided|95.0|-0.013|0.05|||||MMRM method included covariates of Baseline FEV1, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline interaction.||
1603577|NCT02729038|2945353|Other||Ratio of geometric LS means|4.068|||||2-Sided|90.0|2.422|6.831|||||Normal Vs ESRD on hemodialysis (after hemodialysis)||
1603578|NCT02729038|2945353|Other||Ratio of geometric LS means|2.375|||||2-Sided|90.0|1.414|3.989|||||Normal Vs ESRD on hemodialysis (before hemodialysis)||
1603579|NCT02729038|2945354|Other||Ratio of geometric LS means|1.912|||||2-Sided|90.0|1.139|3.212|||||Normal Vs Severe/ESRD not on hemodialysis||
1603580|NCT02729038|2945354|Other||Ratio of geometric LS means|1.501|||||2-Sided|90.0|0.894|2.52|||||Normal Vs Moderate||
1603581|NCT02729038|2945376|Other||Ratio of geometric LS means|5.966|||||2-Sided|90.0|2.363|15.062|||||Cmax for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis)||
1603582|NCT02729038|2945376|Other||Ratio of geometric LS means|2.25|||||2-Sided|90.0|0.891|5.681|||||Cmax for participants with normal renal function Vs ESRD on hemodialysis (before hemodialysis)||
1603583|NCT02729038|2945377|Other||Ratio of geometric LS means|1.575|||||2-Sided|90.0|0.624|3.975|||||Cmax for participants with normal renal function Vs .participants with Severe/ESRD not on hemodialysis||
1603584|NCT02729038|2945377|Other||Ratio of geometric LS means|1.179|||||2-Sided|90.0|0.467|2.977|||||Cmax for participants with normal renal function Vs participants with moderate renal function has been presented.||
1603585|NCT02729038|2945378|Other||Ratio of geometric LS means|4.075|||||2-Sided|90.0|2.438|6.81|||||AUC (0-inf) for participants with normal renal function Vs ESRD on hemodialysis (after hemodialysis)||
1603586|NCT02729038|2945378|Other||Ratio of geometric LS means|2.375|||||2-Sided|90.0|1.421|3.969|||||AUC (0-inf) for participants with normal renal function Vs ESRD on hemodialysis (before hemodialysis)||
1603589|NCT02729025|2945380|Superiority||LS Mean Treatment Difference|-51.29|Standard Error of the Mean|2.15|<|0.0001|2-Sided|95.0|-55.85|-47.33|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference||
1603590|NCT02729025|2945381|Superiority||LS Mean Treatment Difference|-60.66|Standard Error of the Mean|2.6|<|0.0001|2-Sided|95.0|-65.81|-55.51|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference||
1603591|NCT02729025|2945382|Superiority||LS Mean Treatment Difference|-13.89|Standard Error of the Mean|2.73|<|0.0001|2-Sided|95.0|-19.29|-8.49|||Repeated measures linear effects model|The model included treatment group, statin stratification, scheduled visit, and the interaction of treatment with scheduled visit.|Treatment difference used placebo as the reference||
1603592|NCT02729025|2945383|Superiority||LS Mean Treatment Difference|-3.0|Standard Error of the Mean|2.24||0.18|2-Sided|95.0|-7.4|1.39|||Multivariate regression model||Treatment difference used placebo as the reference|A multivariate regression was modelled on the primary endpoint as well as three other response variables (percent change in Lp[a] at Weeks 8 and 16, baseline MDS TBR, and baseline Lp[a]). The primary endpoint was regressed on the treatment group and statin stratification factor; baseline MDS TBR and Lp(a) were regressed on the statin stratification factor, and percent changes in Lp(a) were regressed on the treatment group, statin stratification factor, visit, and treatment group by visit.|
1603593|NCT02727322|2945450|Superiority||Risk Ratio (RR)|1.32||||1|2-Sided|95.0|0.31|5.68|||Fisher Exact||||
1603594|NCT02727322|2945451|Superiority||Risk Ratio (RR)|1.12||||0.665|2-Sided|95.0|0.885|1.43|||Chi-squared||||
1603595|NCT02727322|2945452|Superiority||Risk Ratio (RR)|1.1||||0.97|2-Sided|95.0|0.5|2.04|||Chi-squared||||
1603596|NCT02726971|2945455|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1603597|NCT02726945|2945456|Superiority|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||"Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .~Statistical significance was defined as either of the treatment groups to be superior to the placebo group."|
1603598|NCT02726945|2945456|Superiority|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||"Data from the groups showed a strong non-normal distribution, thus non-parametric methods were used with a Bonferroni correction for multiple comparison .~Statistical significance was defined as either of the treatment groups to be superior to the placebo group."|
1603599|NCT02726022|2945522|Superiority or Other|||||||0.889|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher’s exact test.|
1603600|NCT02726022|2945522|Superiority or Other|||||||0.184|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher’s exact test.|
1603601|NCT02726022|2945523|Superiority or Other|||||||0.237|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher’s exact test.|
1603602|NCT02726022|2945523|Superiority or Other|||||||0.72|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher’s exact test.|
1603603|NCT02726022|2945524|Superiority or Other|||||||0.677|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher’s exact test.|
1603604|NCT02726022|2945524|Superiority or Other|||||||0.052|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher’s exact test.|
1603605|NCT02726022|2945525|Superiority or Other|||||||0.962|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher’s exact test.|
1603606|NCT02726022|2945525|Superiority or Other|||||||0.921|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher’s exact test.|
1603607|NCT02726022|2945526|Superiority or Other|||||||0.86|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between drug addiction status (yes vs no) was tested using Fisher’s exact test.|
1603608|NCT02726022|2945526|Superiority or Other|||||||0.049|||||||Fisher Exact|||The statistical significance of change from baseline to 24 weeks after EOT between gender status (male vs female) was tested using Fisher’s exact test.|
1603609|NCT02726022|2945527|Superiority or Other|||||||0.373|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between drug addiction status (yes vs no) was tested using Fisher’s exact test.|
1603610|NCT02726022|2945527|Superiority or Other|||||||0.647|||||||Fisher Exact|||The statistical significance of change from baseline to EOT between gender status (male vs female) was tested using Fisher’s exact test.|
1603611|NCT02725710|2945548|Other|||||||0.56|||||||Regression, Linear||||
1603612|NCT02725515|2945556|Superiority||Hazard Ratio (HR)|0.53||||0.0252|2-Sided|95.0|0.3|0.92|||Log Rank||||
1603613|NCT02725515|2945557|Superiority||Risk Difference (RD)|17.5||||0.1075|2-Sided|95.0|-3.7|37.3|||Barnard's Unconditional Exact Test P-val||||
1603614|NCT02725515|2945558|Superiority||Risk Difference (RD)|13.4||||0.183|2-Sided|95.0|-6.6|32.6|||Barnard's Unconditional Exact Test P-val||||
1603615|NCT02725008|2945561|Superiority|||||||0.95|||||||t-test, 2 sided||||
1603616|NCT02725008|2945562|Superiority||Odds Ratio (OR)|2.32||||0.3|2-Sided|95.0|0.54|10.07|||Chi-squared||||
1603617|NCT02724111|2945581|Superiority|||||||0.202|||||||Chi-squared||||
1603618|NCT02724111|2945582|Superiority|||||||0.06|||||||t-test, 2 sided||||
1603619|NCT02724111|2945583|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1603620|NCT02724111|2945584|Superiority||||||<|0.001|||||||Chi-squared||||
1603621|NCT02724111|2945585|Superiority||||||<|0.001|||||||Chi-squared||||
1603622|NCT02724111|2945586|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1603625|NCT02723786|2945607|Other||||||||||||||||||The proportion of participants with DGF was 0.57, highest Posterior Density (HPD) 95% Credible interval (CI) (0.25,0.90). The posterior probability for the proportion of participants with DGF <30% was 0.07 (HPD 95% CI [0.00,1.00]). The posterior probability for the proportion of participants with DGF <50% was 0.34 (HPD 95% CI [0.00,1.00]).
1603626|NCT02723630|2945611|Superiority or Other||Geometric Least Squares Mean Ratio|90.64||||0.0498|2-Sided|90.0|83.51|98.38||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.|
1603627|NCT02723630|2945611|Superiority or Other||Geometric Least Squares Mean Ratio|98.73||||0.8448|2-Sided|90.0|88.57|110.06||P value for formulation|Mixed Models Analysis||Geometric Least Squares Mean Ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.|
1603628|NCT02723630|2945612|Superiority or Other||Geometric Least Squares Mean Ratio|95.17||||0.0682|2-Sided|90.0|91.03|99.5||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.|
1603629|NCT02723630|2945612|Superiority or Other||Geometric Least Squares Mean Ratio|100.29||||0.9373|2-Sided|90.0|94.37|106.58||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.|
1603630|NCT02723630|2945613|Superiority or Other||Geometric Least Squares Mean Ratio|93.5||||0.0403|2-Sided|90.0|88.63|98.64||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.|
1603631|NCT02723630|2945613|Superiority or Other||Geometric Least Squares Mean Ratio|99.68||||0.9427|2-Sided|90.0|92.45|107.47||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.|
1603632|NCT02723630|2945614|Superiority or Other||Geometric Least Squares Mean Ratio|96.51||||0.163|2-Sided|90.0|92.53|100.65||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.|
1603633|NCT02723630|2945614|Superiority or Other||Geometric Least Squares Mean Ratio|100.8||||0.8121|2-Sided|90.0|95.31|106.61||P value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and treatment difference mean|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.|
1603634|NCT02723630|2945615|Superiority or Other||Geometric Least Squares Mean Ratio|96.03||||0.1095|2-Sided|90.0|92.11|100.12||P-value for formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and mean treatment difference.|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.|
1603635|NCT02723630|2945615|Superiority or Other||Geometric Least Square Mean Ratio|100.52||||0.8826|2-Sided|90.0|94.84|106.53||P-value for the formulation|Mixed Models Analysis||Geometric LS Mean ratio was back-transformed least squares mean and mean treatment difference.|The effect of crystalline polymorph forms in the drug product on the PK parameters of lenvatinib was estimated using a mixed linear model of logarithmically transformed values of the primary PK parameters with fixed effects for treatment, period, and sequence and a random effect for participant within sequence.|
1603636|NCT02723201|2945621|Superiority or Other||LS Mean Difference|0.836||||0.037|2-Sided|90.0|0.731|0.957|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.|
1603637|NCT02723201|2945621|Superiority or Other||LS Mean Difference|0.116|||<|0.001|2-Sided|90.0|0.077|0.176|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.|
1603638|NCT02723201|2945621|Superiority or Other||LS Mean Difference|1.18|||<|0.423|2-Sided|90.0|1.088|1.279|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.|
1603688|NCT02722330|2945690|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1000 Hz|
1603639|NCT02723201|2945621|Superiority or Other||LS Mean Difference|0.648|||<|0.007|2-Sided|90.0|0.497|0.844|||ANOVA|||ANOVA was performed on the natural logarithms of AUC∞ with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.|
1603640|NCT02723201|2945623|Superiority or Other||LS Mean Difference|0.685||||0.054|2-Sided|90.0|0.499|0.939|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.|
1603641|NCT02723201|2945623|Superiority or Other||LS Mean Difference|0.055|||<|0.001|2-Sided|90.0|0.041|0.074|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.|
1603642|NCT02723201|2945623|Superiority or Other||LS Mean Difference|1.216|||<|0.249|2-Sided|90.0|1.016|1.455|||ANOVA|||ANOVA was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90% CI was obtained by taking the antilog of the difference in the log transformed LS means and its CI, respectively.|
1603643|NCT02723201|2945623|Superiority or Other||LS Mean Difference|0.402|||<|0.001|2-Sided|90.0|0.32|0.505|||ANOVA|||Analysis of variance (ANOVA) was performed on the natural logarithms of Cmax with regimen as the fixed effects and participant as the random effect. The point estimate and 90 percent (%) confidence interval (CI) was obtained by taking the antilog of the difference in the log transformed least square (LS) means and its CI, respectively.|
1603644|NCT02723084|2945647|Non-Inferiority|The percentage of participants achieving SVR12 was calculated for each arm and a 2- sided 95% confidence interval (CI) for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the CI for the difference was above the noninferiority margin of –10%, then arm A was considered non-inferior to arm B.|Risk Difference (RD)|4.3|||||2-Sided|95.0|-3.5|12.1|||||95% CI was calculated using the normal approximation to the binomial distribution.|Difference in SVR12 rates (Arm A - Arm B)|
1603645|NCT02722564|2945672|Other||||||<|0.0001||||||p value associated with change between estimated and actual BrAC as participants BrAC descended to 0.08.|t-test, 2 sided||||
1603646|NCT02722564|2945672|Other||||||<|0.001||||||p value associated with the change between estimated and actual BrAC when the participants BrAC was ascending to 0.1.|t-test, 2 sided||||
1603647|NCT02722330|2945678|Superiority or Other|||||||0.41|||||||Wilcoxon Signed Rank test|||SPL 80 dB|
1603648|NCT02722330|2945678|Superiority or Other|||||||1|||||||Wilcoxon Signed Rank test|||SPL 65 dB|
1603649|NCT02722330|2945678|Superiority or Other|||||||0.096|||||||Wilcoxon Signed Rank test|||SPL 50 dB|
1603650|NCT02722330|2945679|Superiority or Other|||||||0.57|||||||Wilcoxon Signed Rank test|||SPL 80 dB|
1603651|NCT02722330|2945679|Superiority or Other|||||||0.095|||||||Wilcoxon Signed Rank test|||SPL 65 dB|
1603652|NCT02722330|2945679|Superiority or Other|||||||0.017|||||||Wilcoxon Signed Rank test|||SPL 50 dB|
1603653|NCT02722330|2945680|Superiority or Other|||||||0.11|||||||Wilcoxon Signed Rank test||||
1603654|NCT02722330|2945681|Superiority or Other|||||||0.48|||||||Wilcoxon Signed Rank test||||
1603655|NCT02722330|2945682|Superiority or Other|||||||0.71|||||||Wilcoxon Signed Rank test|||6000 Hz|
1603656|NCT02722330|2945682|Superiority or Other|||||||0.014|||||||Wilcoxon Signed Rank test|||4000 Hz|
1603657|NCT02722330|2945682|Superiority or Other|||||||0.38|||||||Wilcoxon Signed Rank test|||3000 Hz|
1603658|NCT02722330|2945682|Superiority or Other|||||||0.11|||||||Wilcoxon Signed Rank test|||2000 Hz|
1603659|NCT02722330|2945682|Superiority or Other|||||||0.39|||||||Wilcoxon Signed Rank test|||1500 Hz|
1603660|NCT02722330|2945682|Superiority or Other|||||||0.16|||||||Wilcoxon Signed Rank test|||1000 Hz|
1603661|NCT02722330|2945682|Superiority or Other|||||||0.56|||||||Wilcoxon Signed Rank test|||750 Hz|
1603662|NCT02722330|2945682|Superiority or Other|||||||0.072|||||||Wilcoxon Signed Rank test|||500 Hz|
1603663|NCT02722330|2945682|Superiority or Other|||||||0.12|||||||Wilcoxon Signed Rank test|||250 Hz|
1603664|NCT02722330|2945683|Superiority or Other|||||||0.0035|||||||Wilcoxon Signed Rank test|||6000 Hz|
1603665|NCT02722330|2945683|Superiority or Other|||||||0.0075|||||||Wilcoxon Signed Rank test|||4000 Hz|
1603666|NCT02722330|2945683|Superiority or Other|||||||0.028|||||||Wilcoxon Signed Rank test|||3000 Hz|
1603667|NCT02722330|2945683|Superiority or Other|||||||0.023|||||||Wilcoxon Signed Rank test|||2000 Hz|
1603668|NCT02722330|2945683|Superiority or Other|||||||0.25|||||||Wilcoxon Signed Rank test|||1500 Hz|
1603669|NCT02722330|2945683|Superiority or Other|||||||0.034|||||||Wilcoxon Signed Rank test|||1000 Hz|
1603670|NCT02722330|2945683|Superiority or Other|||||||0.59|||||||Wilcoxon Signed Rank test|||750 Hz|
1603671|NCT02722330|2945683|Superiority or Other|||||||0.16|||||||Wilcoxon Signed Rank test|||500 Hz|
1603672|NCT02722330|2945683|Superiority or Other|||||||0.47|||||||Wilcoxon Signed Rank test|||250 Hz|
1603673|NCT02722330|2945684|Superiority or Other|||||||0.065|||||||Wilcoxon Signed Rank test||||
1603674|NCT02722330|2945685|Superiority or Other|||||||0.036|||||||Wilcoxon Signed Rank test||||
1603675|NCT02722330|2945686|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 80 dB|
1603676|NCT02722330|2945686|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 65 dB|
1603677|NCT02722330|2945686|Superiority or Other||||||<|0.0001||||||All variable had the same p value (<0.0001).|Wolcoxon Signed rank test|||Speech Presentation Level 50 dB|
1603678|NCT02722330|2945687|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 80 dB|
1603679|NCT02722330|2945687|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 65 dB|
1603680|NCT02722330|2945687|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech Presentation Level 50 dB|
1603693|NCT02722330|2945691|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||4000 Hz|
1603694|NCT02722330|2945691|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||3000 Hz|
1603695|NCT02722330|2945691|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||2000 Hz|
1603696|NCT02722330|2945691|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1500 Hz|
1603697|NCT02722330|2945691|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||1000 Hz|
1603698|NCT02722330|2945691|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||750 Hz|
1603699|NCT02722330|2945691|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||500 Hz|
1603700|NCT02722330|2945691|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||250 Hz|
1603701|NCT02722330|2945692|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test||||
1603702|NCT02722330|2945693|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Qualities scale|
1603703|NCT02722330|2945693|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Spatial scale|
1603704|NCT02722330|2945693|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Speech scale|
1603705|NCT02722330|2945694|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Global score|
1603706|NCT02722330|2945694|Superiority or Other||||||<|0.0004|||||||Wilcoxon Signed rank Test|||Aversiveness|
1603707|NCT02722330|2945694|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Background noise|
1603708|NCT02722330|2945694|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed rank Test|||Reverberation|
1603709|NCT02722330|2945694|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test|||Ease of communication|
1603710|NCT02722330|2945695|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank test||||
1603711|NCT02720523|2945814|Superiority||LS Mean Difference|-1.96|||<|0.001|2-Sided|95.0|-2.73|-1.18|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo||
1603712|NCT02720523|2945814|Superiority||LS Mean Difference|-1.82|||<|0.001|2-Sided|95.0|-2.59|-1.05|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo||
1603713|NCT02720523|2945814|Superiority||LS Mean Difference|-1.81|||<|0.001|2-Sided|95.0|-2.57|-1.04|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo||
1603714|NCT02720523|2945815|Superiority||LS Mean Difference|-1.56||||0.22|2-Sided|95.0|-4.06|0.94|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo||
1603715|NCT02720523|2945815|Superiority||LS Mean Difference|-2.06||||0.08|2-Sided|95.0|-4.36|0.25|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo||
1603716|NCT02720523|2945815|Superiority||LS Mean Difference|-2.54||||0.021|2-Sided|95.0|-4.68|-0.39|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo||
1603717|NCT02720523|2945816|Superiority||LS Mean Difference|0.85||||0.516|2-Sided|95.0|-1.73|3.43|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo||
1603718|NCT02720523|2945816|Superiority||LS Mean Difference|1.79||||0.169|2-Sided|95.0|-0.77|4.35|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo||
1603719|NCT02720523|2945816|Superiority||LS Mean Difference|2.66||||0.04|2-Sided|95.0|0.12|5.2|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo||
1603720|NCT02720523|2945817|Superiority||Response Rate Difference|25.8||||0.002|2-Sided|95.0|10.6|41.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603721|NCT02720523|2945817|Superiority||Response Rate Difference|16.3||||0.026|2-Sided|95.0|2.1|30.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603722|NCT02720523|2945817|Superiority||Response Rate Difference|22.4||||0.006|2-Sided|95.0|7.4|37.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603723|NCT02720523|2945818|Superiority||Response Rate Difference|43.9|||<|0.001|2-Sided|95.0|28.5|59.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603724|NCT02720523|2945818|Superiority||Response Rate Difference|51.0|||<|0.001|2-Sided|95.0|35.6|66.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603725|NCT02720523|2945818|Superiority||Response Rate Difference|30.6|||<|0.001|2-Sided|95.0|15.5|45.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603726|NCT02720523|2945819|Superiority||Response Rate Difference|53.6|||<|0.001|2-Sided|95.0|37.1|70.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603727|NCT02720523|2945819|Superiority||Response Rate Difference|51.0|||<|0.001|2-Sided|95.0|34.2|67.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603728|NCT02720523|2945819|Superiority||Response Rate Difference|34.7|||<|0.001|2-Sided|95.0|17.0|52.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603729|NCT02720523|2945820|Superiority||LS Mean Difference|5.93|||<|0.001|2-Sided|95.0|3.64|8.22|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo||
1603730|NCT02720523|2945820|Superiority||LS Mean Difference|3.5|||<|0.002|2-Sided|95.0|1.25|5.75|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo||
1603731|NCT02720523|2945820|Superiority||LS Mean Difference|4.33|||<|0.001|2-Sided|95.0|2.1|6.57|||Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit and treatment-by-visit interaction, prior bDMARD use, and baseline value as covariate.|Difference = Upadacitinib - Placebo||
1603732|NCT02720523|2945821|Superiority||Response Rate Difference|26.0|||<|0.001|2-Sided|95.0|12.9|39.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603733|NCT02720523|2945821|Superiority||Response Rate Difference|32.7|||<|0.001|2-Sided|95.0|18.7|46.6|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603734|NCT02720523|2945821|Superiority||Response Rate Difference|18.4|||<|0.004|2-Sided|95.0|6.4|30.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603735|NCT02720523|2945822|Superiority||Response Rate Difference|41.7|||<|0.001|2-Sided|95.0|24.5|58.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603736|NCT02720523|2945822|Superiority||Response Rate Difference|49.0|||<|0.001|2-Sided|95.0|32.1|65.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603737|NCT02720523|2945822|Superiority||Response Rate Difference|24.5|||<|0.007|2-Sided|95.0|7.3|41.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1603738|NCT02720523|2945823|Superiority||LS Mean Difference|-0.39|||<|0.001|2-Sided|95.0|-0.55|-0.229|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo||
1603739|NCT02720523|2945823|Superiority||LS Mean Difference|-0.34|||<|0.001|2-Sided|95.0|-0.505|-0.184|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo||
1603740|NCT02720523|2945823|Superiority||LS Mean Difference|-0.3|||<|0.001|2-Sided|95.0|-0.465|-0.144|||ANCOVA|ANCOVA model includes treatment as the fixed factor, and the baseline value and stratification factor prior bDMARD use as the covariates.|Difference = Upadacitinib - Placebo||
1603741|NCT02720523|2945824|Superiority||LS Mean Difference|-1.62|||<|0.001|2-Sided|95.0|-2.027|-1.216|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo||
1603742|NCT02720523|2945824|Superiority||LS Mean Difference|-1.6|||<|0.001|2-Sided|95.0|-2.005|-1.19|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo||
1603743|NCT02720523|2945824|Superiority||Least Squares (LS) Mean Difference|-1.29|||<|0.001|2-Sided|95.0|-1.693|-0.88|||ANCOVA|ANCOVA model including treatment as the fixed factor, and baseline value and the stratification factor prior bDMARD use as covariates.|Difference = Upadacitinib - Placebo||
1603744|NCT02720523|2945825|Other|Cochran-Armitage test was conducted for demonstrating a dose response relationship.|||||<|0.001|||||||Cochran-Armitage test||||
1603745|NCT02720523|2945825|Superiority||Response Rate Difference|37.1|||<|0.001|2-Sided|95.0|19.4|54.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib – Placebo||
1603746|NCT02720523|2945825|Superiority||Response Rate Difference|40.8|||<|0.001|2-Sided|95.0|23.5|58.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib – Placebo||
1603747|NCT02720523|2945825|Superiority||Response Rate Difference|32.7|||<|0.001|2-Sided|95.0|14.3|51.0|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor prior bDMARD use.|Response Rate Difference = Upadacitinib – Placebo||
1603748|NCT02720198|2945863|Superiority||Mean Difference (Final Values)|-0.459|Standard Error of the Mean|1.035||0.66|2-Sided|95.0|-2.54|1.623|||t-test, 2 sided||||
1603749|NCT02720198|2945864|Superiority||Mean Difference (Final Values)|-0.236|Standard Error of the Mean|2.158||0.913|2-Sided|95.0|-4.559|4.088|||t-test, 2 sided||||
1603750|NCT02720198|2945865|Superiority||Mean Difference (Final Values)|-3.693|Standard Error of the Mean|1.91||0.058|2-Sided|95.0|-7.52|0.134|||t-test, 2 sided||||
1603751|NCT02720198|2945866|Superiority||Mean Difference (Final Values)|1.64|Standard Error of the Mean|1.423||0.254|2-Sided|95.0|-1.211|4.492|||t-test, 2 sided||||
1603752|NCT02720198|2945867|Superiority||Odds Ratio (OR)|0.875|Standard Error of the Mean|0.65||0.905|2-Sided|95.0|0.245|3.129|||Mantel Haenszel||||
1603753|NCT02720198|2945868|Superiority||Odds Ratio (OR)|1.063|Standard Error of the Mean|0.525||0.884|2-Sided|95.0|0.38|2.971|||Mantel Haenszel||||
1603754|NCT02720198|2945869|Superiority||Mean Difference (Final Values)|2.34|Standard Error of the Mean|2.199||0.292|2-Sided|95.0|-2.07|6.75|||t-test, 2 sided||||
1603755|NCT02720198|2945870|Superiority||Mean Difference (Final Values)|-0.624|Standard Error of the Mean|1.428||0.664|2-Sided|95.0|-3.484|2.236|||t-test, 2 sided||||
1603756|NCT02720198|2945871|Superiority||Odds Ratio (OR)|0.451|Standard Error of the Mean|0.724||0.272|2-Sided|95.0|0.109|1.866|||Mantel Haenszel||||
1603757|NCT02720198|2945872|Superiority||Odds Ratio (OR)|0.492|Standard Error of the Mean|0.806||0.428|2-Sided|95.0|0.101|2.388|||Mantel Haenszel||||
1603758|NCT02720198|2945873|Superiority||Mean Difference (Final Values)|1.159|Standard Error of the Mean|1.834||0.53|2-Sided|95.0|-2.518|4.836|||t-test, 2 sided||||
1603759|NCT02720107|2945877|Superiority or Other||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||TH17 central memory cells|
1603760|NCT02720107|2945877|Superiority or Other||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Effector memory T cells|
1603761|NCT02720107|2945877|Superiority or Other||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Central memory T cells|
1603762|NCT02720107|2945877|Superiority or Other||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD8+ Naïve T cells|
1603763|NCT02720107|2945877|Superiority or Other||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Effector memory T cells|
1603764|NCT02720107|2945877|Superiority or Other||||||<|0.0493||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from study Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Central memory T cells|
1603765|NCT02720107|2945877|Superiority or Other||||||<|0.0001||||||The ANCOVA model included the covariates center, baseline of corresponding cell counts from Core study, sex and duration of disease until start of Core study|ANCOVA|||CD4+ Naïve T cells|
1603766|NCT02720081|2945878|Superiority||Difference in least squares means|0.107||||0.023|2-Sided|95.0|0.015|0.199|||Constrained longitudinal data analysis|Terms for treatment, time, interaction of time by treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.|||
1603767|NCT02720081|2945900|Other||Difference in percentages|-4.3|||||2-Sided|95.0|-12.1|1.0|||||Based on Miettinen & Nurminen||
1603768|NCT02720081|2945901|Other||Difference in percentages|-0.4|||||2-Sided|95.0|-15.0|14.3|||||Based on Miettinen & Nurminen||
1603769|NCT02720081|2945902|Superiority||Difference in least squares means|-4.775||||0.352|2-Sided|95.0|-14.92|5.37|||ANOVA|Terms for treatment, number of C alleles at the pre-specified SNP, and prior inhaled corticosteroid use.|||
1603770|NCT02719938|2945904|Superiority|||||||0.516|||||||t-test, 2 sided||||
1603771|NCT02719938|2945905|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1603772|NCT02719938|2945906|Superiority||||||<|0.001|||||||Chi-squared||||
1603773|NCT02719938|2945907|Superiority|||||||0.019|||||||Chi-squared||||
1603774|NCT02719938|2945908|Superiority|||||||0.409|||||||t-test, 2 sided||||
1603775|NCT02719938|2945909|Superiority|||||||0.521|||||||t-test, 2 sided||||
1603776|NCT02719938|2945910|Superiority|||||||0.415|||||||t-test, 2 sided||||
1603777|NCT02719171|2945943|Other||Mean Difference (Final Values)|48.8|||<|0.001|2-Sided|90.0|33.1|64.5|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.|
1603778|NCT02719171|2945943|Other||Mean Difference (Final Values)|53.5|||<|0.001|2-Sided|90.0|35.9|71.1|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.|
1603779|NCT02719171|2945944|Other||Mean Difference (Final Values)|-2.8||||0.111|2-Sided|90.0|-5.7|0.1|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603780|NCT02719171|2945944|Other||Mean Difference (Final Values)|-1.2||||0.453|2-Sided|90.0|-4.0|1.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603781|NCT02719171|2945945|Other||Mean Difference (Final Values)|-0.9||||0.16|2-Sided|90.0|-2.1|0.2|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603782|NCT02719171|2945945|Other||Mean Difference (Final Values)|-0.7||||0.325|2-Sided|90.0|-1.8|0.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603783|NCT02719171|2945946|Other||Mean Difference (Final Values)|0.1||||0.906|2-Sided|90.0|-1.0|1.1|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603784|NCT02719171|2945946|Other||Mean Difference (Final Values)|1.2||||0.243|2-Sided|90.0|-0.5|2.8|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603785|NCT02719171|2945947|Other||Mean Difference (Final Values)|2.06||||0.204|2-Sided|90.0|-0.61|4.74|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603786|NCT02719171|2945947|Other||Mean Difference (Final Values)|0.59||||0.718|2-Sided|90.0|-2.12|3.3|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603787|NCT02719171|2945948|Other||Mean Difference (Final Values)|1.35||||0.284|2-Sided|90.0|-0.73|3.44|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603788|NCT02719171|2945948|Other||Mean Difference (Final Values)|1.7||||0.174|2-Sided|90.0|-0.36|3.77|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603789|NCT02719171|2945949|Other||Mean Difference (Final Values)|-0.114||||0.181|2-Sided|90.0|-0.254|0.027|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603790|NCT02719171|2945949|Other||mixed model repeated measures model|-0.082||||0.341|2-Sided|90.0|-0.225|0.06|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603791|NCT02719171|2945950|Other||Mean Difference (Final Values)|-1.1||||0.32|2-Sided|90.0|-2.8|0.7|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603792|NCT02719171|2945950|Other||Mean Difference (Final Values)|-0.3||||0.791|2-Sided|90.0|-2.1|1.5|||Cochran-Mantel-Haenszel|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603793|NCT02719171|2945951|Other||Mean Difference (Final Values)|-2.1||||0.26|2-Sided|90.0|-5.3|1.0|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603794|NCT02719171|2945951|Other||Mean Difference (Final Values)|-0.8||||0.69|2-Sided|90.0|-4.0|2.5|||mixed model repeated measures model|||The 2-sided p-value is calculated using a mixed model repeated measures model with categorical fixed effects of treatment, stratification factors, week, and treatment-by-week interaction and the continuous fixed baseline measurement, with subject as a random effect.|
1603795|NCT02719171|2945952|Other||Mean Difference (Final Values)|15.7|||<|0.001|2-Sided|90.0|8.5|22.9|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.|
1603796|NCT02719171|2945952|Other||Mean Difference (Final Values)|10.3|||<|0.006|2-Sided|90.0|4.1|16.4|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.|
1603797|NCT02719171|2945953|Other||Mean Difference (Final Values)|19.0||||0.007|2-Sided|90.0|7.4|30.6|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.|
1603798|NCT02719171|2945953|Other||Mean Difference (Final Values)|12.0||||0.074|2-Sided|90.0|1.0|23.0|||Cochran-Mantel-Haenszel|||The 90% CI for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior TNFi use and concurrent methotrexate use.|
1603799|NCT02719171|2945954|Other||Mean Difference (Final Values)|24.0||||0.007|2-Sided|90.0|9.3|38.7|||Cochran-Mantel-Haenszel|||The 90% confidence interval (CI) for the difference in response rates between the groups and the 2-sided p-value are calculated using the Cochran Mantel-Haenszel method, stratified by prior tumor necrosis factor inhibitor (TNFi) use and concurrent methotrexate use.|
1603800|NCT02718898|2945960|Superiority||Mean Difference (Final Values)|-3.55|Standard Error of the Mean|0.385|<|0.001|2-Sided|95.0|-4.31|-2.79|||Mixed Models Analysis|||Cracking|
1603801|NCT02718898|2945960|Superiority||Mean Difference (Final Values)|-3.78|Standard Error of the Mean|0.377|<|0.001|2-Sided|95.0|-4.53|-3.03|||Mixed Models Analysis|||Scaling|
1603802|NCT02718898|2945960|Superiority||Mean Difference (Final Values)|-3.81|Standard Error of the Mean|0.395|<|0.001|2-Sided|95.0|-4.59|-3.03|||Mixed Models Analysis|||Redness|
1603803|NCT02718898|2945960|Superiority||Mean Difference (Final Values)|-3.2|Standard Error of the Mean|0.397|<|0.001|2-Sided|95.0|-3.99|-2.41|||Mixed Models Analysis|||Burning|
1603804|NCT02718898|2945960|Superiority||Mean Difference (Final Values)|-3.23|Standard Error of the Mean|0.41|<|0.001|2-Sided|95.0|-4.04|-2.42|||Mixed Models Analysis|||Stinging|
1603805|NCT02718898|2945960|Superiority||Mean Difference (Final Values)|-3.85|Standard Error of the Mean|0.41|<|0.001|2-Sided|95.0|-4.66|-3.04|||Mixed Models Analysis|||Discomfort|
1603806|NCT02718898|2945960|Superiority||Mean Difference (Final Values)|-3.5|Standard Error of the Mean|0.405|<|0.001|2-Sided|95.0|-4.3|-2.7|||Mixed Models Analysis|||Pain|
1603807|NCT02718898|2945960|Superiority||Mean Difference (Final Values)|-3.81|Standard Error of the Mean|0.399|<|0.001|2-Sided|95.0|-4.6|-3.02|||Mixed Models Analysis|||Itch|
1603808|NCT02718898|2945960|Superiority||Mean Difference (Final Values)|-28.75|Standard Error of the Mean|3.015|<|0.001|2-Sided|95.0|-34.72|-22.78|||Mixed Models Analysis|||Total Score|
1603809|NCT02718898|2945961|Superiority||Mean Difference (Final Values)|1.797|Standard Error of the Mean|1.0367||0.085|2-Sided|95.0|-0.253|3.847|||ANCOVA||||
1603810|NCT02718898|2945962|Superiority||Mean Difference (Final Values)|4.506|Standard Error of the Mean|1.1339|<|0.001|2-Sided|95.0|2.264|6.748|||ANCOVA||||
1603811|NCT02718898|2945963|Superiority||Odds Ratio (OR)|13.95|||<|0.001|2-Sided|95.0|6.12|31.8|||Regression, Logistic||||
1603812|NCT02718898|2945964|Superiority||Mean Difference (Final Values)|-20.0|Standard Error of the Mean|2.15|<|0.001|2-Sided|95.0|-24.3|-15.8|||Mixed Models Analysis||||
1603813|NCT02718898|2945965|Superiority||Mean Difference (Final Values)|-8.4|Standard Error of the Mean|0.86|<|0.001|2-Sided|95.0|-10.1|-6.7|||Mixed Models Analysis||||
1603814|NCT02718898|2945966|Superiority||Odds Ratio (OR)|9.84|||<|0.001|2-Sided|95.0|3.08|31.4|||Regression, Logistic||||
1603815|NCT02718898|2945967|Superiority||Odds Ratio (OR)|13.57|||<|0.001|2-Sided|95.0|4.57|40.29|||Regression, Logistic||||
1603816|NCT02718898|2945968|Superiority||Odds Ratio (OR)|16.27|||<|0.001|2-Sided|95.0|5.71|46.4|||Regression, Logistic||||
1603817|NCT02718898|2945969|Superiority||Odds Ratio (OR)|102.55|||<|0.001|2-Sided|95.0|22.79|461.43|||Regression, Logistic||||
1603818|NCT02718898|2945970|Superiority||Odds Ratio (OR)|33.8|||<|0.001|2-Sided|95.0|12.39|92.23|||Regression, Logistic||||
1603819|NCT02718417|2946002|Other||Hazard Ratio (HR)|0.9||||0.2367|2-Sided|95.0|0.688|1.189||One-sided log-rank test was used.|Log Rank||||
1603820|NCT02718417|2946002|Other||Hazard Ratio (HR)|1.21||||0.9278|2-Sided|95.0|0.935|1.578||One-sided log-rank test was used.|Log Rank||||
1603821|NCT02718417|2946003|Superiority||Hazard Ratio (HR)|1.55||||0.8953|2-Sided|95.0|0.776|3.111||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox’s Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.|||
1603822|NCT02718417|2946003|Superiority||Hazard Ratio (HR)|1.53||||0.8848|2-Sided|95.0|0.76|3.08||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox’s Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.|||
1603823|NCT02718417|2946004|Superiority||Hazard Ratio (HR)|1.14||||0.7935|2-Sided|95.0|0.832|1.565||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox’s Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.|||
1603824|NCT02718417|2946004|Superiority||Hazard Ratio (HR)|1.43||||0.989|2-Sided|95.0|1.051|1.946||One-sided log-rank test was used.|Log Rank|Analysis was performed using a Cox’s Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.|||
1603825|NCT02718326|2946005|Superiority||Estimate for contrast|1.14||||0.0057|2-Sided|95.0|0.33|1.94|||ANOVA||||
1603826|NCT02718326|2946005|Superiority||Estimate for contrast|0.8||||0.0529|2-Sided|95.0|-0.01|1.6|||ANOVA||||
1603827|NCT02718326|2946006|Superiority||percentage difference|-6.0||||0.0089|2-Sided|95.0|-10.5|-1.6|||Cochran-Mantel-Haenszel||||
1603828|NCT02718326|2946006|Superiority||percentage difference|-6.0||||0.0096|2-Sided|95.0|-10.5|-1.5|||Cochran-Mantel-Haenszel||||
1603829|NCT02718326|2946009|Superiority||percentage difference|-18.9|||<|0.0001|2-Sided|95.0|-27.5|-10.4|||Cochran-Mantel-Haenszel||||
1603830|NCT02718326|2946009|Superiority||percentage difference|-17.3|||=|0|2-Sided|95.0|-26.2|-8.5|||Cochran-Mantel-Haenszel||||
1603831|NCT02718326|2946010|Superiority||percentage difference|-16.6|||<|0.0001|2-Sided|95.0|-24.2|-9.1|||Cochran-Mantel-Haenszel||||
1603832|NCT02718326|2946010|Superiority||percentage difference|-17.3|||<|0.0001|2-Sided|95.0|-24.7|-9.9|||Cochran-Mantel-Haenszel||||
1603833|NCT02718326|2946011|Superiority||percentage difference|64.8|||<|0.0001|2-Sided|95.0|55.8|73.9|||Cochran-Mantel-Haenszel||||
1603834|NCT02718326|2946011|Superiority||percentage difference|50.1|||<|0.0001|2-Sided|95.0|40.1|60.1|||Cochran-Mantel-Haenszel||||
1603835|NCT02718326|2946012|Superiority||percentage difference|52.3|||<|0.0001|2-Sided|95.0|45.2|59.5|||Cochran-Mantel-Haenszel||||
1603836|NCT02717494|2946067|Other||% infants with >=0.35ug/mL at week 24|98.0|||||2-Sided|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603837|NCT02717494|2946067|Other||% infants with >=0.35ug/mL at week 24|99.0|||||2-Sided|95.0|95.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603838|NCT02717494|2946067|Other||% infants with >=0.35ug/mL at week 24|100.0|||||2-Sided|95.0|96.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603839|NCT02717494|2946067|Other||% infants with >=0.35ug/mL at week 16|97.0|||||2-Sided|95.0|91.0|99.0|||||||Confidence intervals were Exact Clopper-Pearson.
1603840|NCT02717494|2946067|Other||% infants with >=0.35ug/mL at week 16|98.0|||||2-Sided|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603841|NCT02717494|2946067|Other||% infants with >=0.35ug/mL at week 16|100.0|||||2-Sided|95.0|96.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603842|NCT02717494|2946068|Other||% vaccinees with >=2fold increase|100.0|||||2-Sided|95.0|93.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603843|NCT02717494|2946068|Other||% vaccinees with >=2fold increase|98.0|||||2-Sided|95.0|94.0|100.0|||||||Confidence intervals were Exact Clopper-Pearson.
1603844|NCT02717494|2946069|Other||% vaccinees with >=2fold increase|98.0|||||2-Sided|95.0|89.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603845|NCT02717494|2946069|Other||% vaccinees with >=2fold increase|96.0|||||2-Sided|95.0|91.0|99.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603846|NCT02717494|2946070|Superiority|This is the test to compare the two vaccine arms with respect to proportion of participants with >=2 fold increase at 24 weeks post partum.||||||0.21|||||||Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.|||
1603847|NCT02717494|2946070|Superiority|This is the test to compare the two vaccine arms with respect to proportion of participants with >=2 fold increase at labor and delivery.||||||0.37||||||The threshold for statistical significance is 0.05.|Chi-squared||||
1603848|NCT02717494|2946071|Superiority|||||||0.08||||||The threshold for statistical significance is 0.05.|t-test, 2 sided||||
1603849|NCT02717494|2946072|Superiority|||||||0.29||||||The threshold for statistical significance is 0.05.|Chi-squared||||
1603850|NCT02717494|2946073|Other||% with >=0.35ug/mL at day 28|94.0|||||2-Sided|95.0|88.0|97.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603851|NCT02717494|2946073|Other||% vaccinees with >=0.35ug/mL at day 28|100.0|||||2-Sided|95.0|97.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603852|NCT02717494|2946073|Other||% vaccinees with >=0.35ug/mL at day 28|99.0|||||2-Sided|95.0|95.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603853|NCT02717494|2946073|Other||% with >=2 fold increase|6.0|||||2-Sided|95.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603854|NCT02717494|2946073|Other||% vaccinees with >=2fold increase|98.0|||||2-Sided|95.0|94.0|100.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603855|NCT02717494|2946073|Other||% vaccinees with >=2fold increase|96.0|||||2-Sided|95.0|91.0|99.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603856|NCT02717494|2946073|Superiority|This is the test to compare the two vaccine arms with respect to proportion of participants with values >=0.35ug/mL at day 28.||||||0.49||||||The threshold for statistical significance is 0.05.|Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.|||
1603857|NCT02717494|2946073|Superiority|This is the test to compare the two vaccine arms with respect to proportion of participants with >=2 fold increase at day 28.||||||0.44||||||The threshold for statistical significance is 0.05.|Fisher Exact|Fisher's exact test was used because 50% of the cells had expected counts less than 5.|||
1603858|NCT02717494|2946074|Other||% with pneumonia, meningitis or IPD|7.0|||||2-Sided|90.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603859|NCT02717494|2946074|Other||% with pneumonia, meningitis or IPD|7.0|||||2-Sided|90.0|3.0|12.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603860|NCT02717494|2946074|Other||% with pneumonia, meningitis or IPD|4.0|||||2-Sided|90.0|2.0|9.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603861|NCT02717494|2946074|Other||% infants with HIV infection|0.0|||||2-Sided|90.0|0.0|2.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603862|NCT02717494|2946074|Other||% infants with HIV infection|0.0|||||2-Sided|90.0|0.0|3.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603863|NCT02717494|2946074|Other||% infants with HIV infection|0.0|||||2-Sided|90.0|0.0|3.0|||||||Confidence intervals were Exact Clopper-Pearson.
1603864|NCT02717494|2946074|Other||% infants with congenital anomalies|13.0|||||2-Sided|90.0|8.0|19.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603865|NCT02717494|2946074|Other||% infants with congenital anomalies|22.0|||||2-Sided|90.0|15.0|29.0|||||||Confidence intervals were Exact Clopper-Pearson.
1603866|NCT02717494|2946074|Other||% infants with congenital anomalies|17.0|||||2-Sided|90.0|11.0|24.0|||||||Confidence intervals were Exact Clopper-Pearson.
1603867|NCT02717494|2946074|Other||% infants with grade 3+ AEs|20.0|||||2-Sided|90.0|14.0|27.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603868|NCT02717494|2946074|Other||% infants with grade 3+ AEs|20.0|||||2-Sided|90.0|14.0|27.0|||||||Confidence intervals were Exact Clopper-Pearson.
1603869|NCT02717494|2946074|Other||% infants with grade 3+ AEs|21.0|||||2-Sided|90.0|14.0|28.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603870|NCT02717494|2946075|Other||% with grade 3+ AEs, up to week 4 Step 2|0.0|||||2-Sided|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603871|NCT02717494|2946075|Other||% with grade 3+ AEs, up to week 4 Step 2|0.0|||||2-Sided|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603872|NCT02717494|2946076|Other||% with Grade 3+ related to treatment|1.0|||||2-Sided|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603873|NCT02717494|2946076|Other||% with Grade 3+ related to treatment|1.0|||||2-Sided|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603874|NCT02717494|2946076|Other||% with Grade 3+ related to treatment|1.0|||||2-Sided|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603875|NCT02717494|2946076|Other||% with grade 4+ AEs, after week 4 Step 1|3.0|||||2-Sided|90.0|1.0|8.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603876|NCT02717494|2946076|Other||% with grade 4+ AEs after week 4, Step 1|2.0|||||2-Sided|90.0|0.0|5.0|||||||Confidence intervals were Exact Clopper-Pearson.
1603877|NCT02717494|2946076|Other||% with grade 4+ AEs after week 4, Step 1|1.0|||||2-Sided|90.0|0.0|4.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603878|NCT02717494|2946076|Other||% with grade 3+ AEs up to week 4, Step 1|3.0|||||2-Sided|90.0|1.0|8.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603879|NCT02717494|2946076|Other||% with grade 3+ AEs, up to week 4 Step 1|3.0|||||2-Sided|90.0|1.0|7.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603880|NCT02717494|2946076|Other||% with grade 3+ AEs, up to week 4 Step 1|2.0|||||2-Sided|90.0|0.0|5.0|||||Confidence intervals were Exact Clopper-Pearson.||
1603881|NCT02717195|2946090|Superiority||Mean Difference (Final Values)|-0.71||||0.4478|2-Sided|95.0|-2.54|1.12||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values>0.05.|Mixed model repeated measures|||The mean changes in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.|
1603882|NCT02717195|2946090|Superiority||Mean Difference (Final Values)|0.96||||0.2998|2-Sided|95.0|-0.86|2.78||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PSP score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.|
1603883|NCT02717195|2946091|Superiority||Mean Difference (Final Values)|1.67||||0.1474|2-Sided|95.0|-0.59|3.94||Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.|
1603884|NCT02717195|2946091|Superiority||Mean Difference (Final Values)|-0.12||||0.9196|2-Sided|95.0|-2.37|2.13||Multiplicity adjustment was planned for the testing of the primary enpoint, but was not applied since all p-values>0.05.|Mixed model repeated measures|||The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors.|
1603885|NCT02716818|2946100|Superiority||Median Difference (Final Values)|0.009|||=|0|2-Sided|95.0|-0.007|0.025|||ANCOVA||||
1603886|NCT02716818|2946101|Superiority||Median Difference (Final Values)|0.425|||=|0|2-Sided|95.0|-0.455|1.305|||ANCOVA|||German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.|
1603887|NCT02716818|2946101|Superiority||Mean Difference (Final Values)|-0.96|||=|0|2-Sided|95.0|-2.294|0.374|||ANCOVA|||German subjects have been excluded from this analysis group as DEXA scans are not performed at German sites.|
1603888|NCT02716818|2946102|Superiority||Odds Ratio (OR)|0.93|||=|0|2-Sided|95.0|0.43|2.02|||Regression, Logistic||||
1603889|NCT02716818|2946102|Superiority||Odds Ratio (OR)|0.99|||=|0|2-Sided|95.0|0.45|2.19|||Regression, Logistic||||
1603890|NCT02716818|2946103|Superiority||Mean Difference (Final Values)|-0.568|||=|0|2-Sided|95.0|-1.799|0.662|||ANCOVA||||
1603891|NCT02716818|2946103|Superiority||Mean Difference (Final Values)|0.116|||=|0|2-Sided|95.0|-0.257|0.489|||ANCOVA||||
1603892|NCT02716818|2946103|Superiority||Median Difference (Final Values)|0.092|||=|0|2-Sided|95.0|-0.343|0.527|||ANCOVA||||
1603893|NCT02716818|2946103|Superiority||Mean Difference (Final Values)|0.065|||=|0|2-Sided|95.0|-1.32|1.451|||ANCOVA||||
1603894|NCT02716818|2946103|Superiority||Mean Difference (Final Values)|-0.135|||=|0|2-Sided|95.0|-0.508|0.237|||ANCOVA||||
1603895|NCT02716818|2946103|Superiority||Mean Difference (Final Values)|-0.037|||=|0|2-Sided|95.0|-0.354|0.281|||ANCOVA||||
1603896|NCT02716818|2946104|Superiority||Mean Difference (Final Values)|0.047|||=|0|2-Sided|95.0|-0.234|0.329|||ANCOVA|||Change from Baseline to 24 Weeks in A4 Using an ANCOVA Model - The analysis conducted for the primary endpoint variable analysis of 17-OHP was repeated for A4.|
1603897|NCT02716818|2946105|Superiority||Mean Difference (Final Values)|-0.069|||=|0|2-Sided|95.0|-0.299|0.161|||ANCOVA|||The primary efficacy variable was the natural logarithm of the mean of the 24-hour SDS profile for the natural logarithm of 17-OHP. The SDS profile was calculated as the SDS of log transformed 17-OHP concentration unsigned. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs, with the first and last (13th) weighted one half relative to the intermediate SDSs.|
1603898|NCT02716584|2946131|Superiority||Effect size|0.05||||0.86|2-Sided||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.|||
1603899|NCT02716584|2946132|Superiority||Effect size|0.0||||0.88|2-Sided||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.|||
1603900|NCT02716584|2946133|Superiority||Effect size|0.72||||0.07|2-Sided||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.|||
1603901|NCT02716584|2946134|Superiority||Effect size|0.35||||0.12|2-Sided||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.|||
1603902|NCT02716584|2946135|Superiority||Effect size|0.02||||0.57|2-Sided||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.|||
1603903|NCT02716584|2946136|Superiority||Effect size|0.77||||0.23|2-Sided|||||For cohort 3, positive affect was measured at a baseline and midpoint assessment.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate.|||
1603904|NCT02716584|2946136|Superiority||Effect size|-0.21||||0.62|2-Sided|||||The analyses for cohorts 1 and 2 utilized the a priori endpoint assessment conducted 1-2 weeks after completion of training.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.|||
1603905|NCT02716584|2946137|Superiority||Effect size|0.73||||0.33|2-Sided|||||For cohort 3, positive affect was measured at baseline and a midpoint assessment.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, midpoint) repeated measures ANCOVA with number of sessions attended as a covariate.|||
1603906|NCT02716584|2946137|Superiority||Effect size|0.19||||0.73|2-Sided|||||The analyses for cohorts 1 and 2 utilized the a priori endpoint assessment conducted 1-2 weeks after completion of training.|ANCOVA|The data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.|||
1603907|NCT02716584|2946138|Superiority|||||||0.13|||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.|||
1603908|NCT02716584|2946139|Superiority||Effect size|0.35||||0.06|2-Sided||||||ANCOVA|Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of sessions attended as a covariate.|||
1603909|NCT02716584|2946140|Superiority||Effect size|0.41||||0.02|2-Sided||||||ANCOVA|||Data were analyzed using a 2 (groups) x 2 (time: baseline, endpoint) repeated measures ANCOVA with number of exercise sessions attended as a covariate.|
1603910|NCT02716324|2946143|Superiority||Beta coefficient|0.136||||0.285|2-Sided|95.0|-0.138|0.41|||Random effects model|||Random effects models regressed Understanding Engagement Scores Scores on intervention status adjusted for season and clustered by doctor’s office.|
1603911|NCT02716324|2946143|Superiority||Beta coefficient|0.073||||0.527|2-Sided|95.0|-0.182|0.328|||Random effects model|||Random effects models regressed Communication Engagement Scores Scores on intervention status adjusted for season and clustered by doctor’s office.|
1604024|NCT02713204|2946315|Superiority||Least square mean difference|0.05||||0.9558|2-Sided|95.0|-1.69|1.79||Threshold for significance at 0.05 level.|ANCOVA||||
1603912|NCT02716324|2946143|Superiority||Beta coefficient|-0.013||||0.885|2-Sided|95.0|-0.217|0.191|||Random effects model|||Random effects models regressed Patient Family Centered Care Engagement Scores Scores on intervention status adjusted for season and clustered by doctor’s office.|
1603913|NCT02716324|2946143|Superiority||Beta coefficient|0.074||||0.495|2-Sided|95.0|-0.164|0.311|||Random effects model|||Random effects models regressed Access Engagement Scores Scores on intervention status adjusted for season and clustered by doctor’s office.|
1603914|NCT02716324|2946144|Superiority||Beta coefficient|0.0||||0.679|2-Sided|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Family Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. The threshold for statistical significance was p<0.05.|Random effects model|||Random effects models regressed Child-reported PRO Family Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. we examined intervention X time interaction term for statistical significance.|
1603915|NCT02716324|2946145|Superiority||Beta coefficient|0.0||||0.888|2-Sided|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. The threshold for statistical significance was p<0.05.|Random effects model|||Random effects models regressed Child-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. we examined intervention X time interaction term for statistical significance.|
1603916|NCT02716324|2946145|Superiority||Beta coefficient|0.0||||0.873|2-Sided|95.0|-0.001|0.001||Random effects models regressed Parent Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. The threshold for statistical significance was p<0.05.|Random effects model|||Random effects models regressed Parent-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. we examined intervention X time interaction term for statistical significance.|
1603917|NCT02716324|2946146|Superiority||Beta coefficient|0.0||||0.735|2-Sided|95.0|-0.001|0.001||Random effects models regressed Child Patient Reported Outcomes Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. The threshold for statistical significance was p<0.05.|Random effects model|||Random effects models regressed Child PRO Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. we examined intervention X time interaction term for statistical significance.|
1603918|NCT02716324|2946147|Superiority||Beta coefficient|0.0||||0.735|2-Sided|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Child PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. we examined intervention X time interaction term for statistical significance.|
1603919|NCT02716324|2946147|Superiority||Beta coefficient|0.0||||0.707|2-Sided|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Parent-reported PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. we examined intervention X time interaction term for statistical significance.|
1603920|NCT02716324|2946148|Superiority||Beta coefficient|0.001||||0.075|2-Sided|95.0|0.0|0.002|||Random effects model|||Random effects models regressed Child PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. we examined intervention X time interaction term for statistical significance.|
1603921|NCT02716324|2946148|Superiority||Beta coefficient|0.0||||0.662|2-Sided|95.0|-0.001|0.001|||Random effects model|||Random effects models regressed Parent-reported PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. we examined intervention X time interaction term for statistical significance.|
1603922|NCT02716324|2946149|Superiority|||||||1|||||||Chi-squared|||Differences in proportions between the two groups in use of inpatient mental health services during the study period were assessed using the Chi-square Test.|
1603923|NCT02716324|2946149|Superiority|||||||0.251|||||||Chi-squared|||Differences in proportions between the two groups in use of ambulatory mental health services during the study period were assessed using the Chi-square Test.|
1603924|NCT02716324|2946149|Superiority|||||||0.31|||||||Chi-squared|||Differences in proportions between the two groups in use of any mental health services during the study period were assessed using the Chi-square Test.|
1603925|NCT02716324|2946150|Superiority|||||||0.915|||||||Chi-squared|||Differences in proportions between the two groups in use of any inpatient mental health services were assessed using the Chi-square Test.|
1603926|NCT02716324|2946150|Superiority|||||||0.903|||||||Chi-squared|||Differences in proportions between the two groups in use of ambulatory mental health services were assessed using the Chi-square Test.|
1603927|NCT02716324|2946150|Superiority|||||||0.718|||||||Chi-squared|||Differences in proportions between the two groups in use of any services were assessed using the Chi-square Test.|
1603928|NCT02716324|2946151|Superiority||Beta coefficient|0.001||||0.499|2-Sided|95.0|-0.002|0.004|||Random effects model|||Random effects models regressed GAS scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. We examined intervention X time interaction term for statistical significance.|
1603929|NCT02716324|2946152|Superiority||Beta Coefficient|0.001||||0.871|2-Sided|95.0|-0.01|0.012|||GLS random-effects model|||Random effects models regressed VPRS scores on intervention status, time (days), intervention by time, season, and clustered by doctor’s office. We examined intervention X time interaction term for statistical significance.|
1603930|NCT02715726|2946184|Superiority||LS mean difference|1.9||||0.228|2-Sided|95.0|-1.2|4.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603931|NCT02715726|2946185|Superiority||Adjusted Mean Difference|-34.273|||<|0.0001|2-Sided|95.0|-39.262|-29.285||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603932|NCT02715726|2946186|Superiority||Odds Ratio (OR)|13.6|||<|0.0001|2-Sided|95.0|8.3|22.3||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603933|NCT02715726|2946187|Superiority||Odds Ratio (OR)|11.2|||<|0.0001|2-Sided|95.0|7.1|17.7||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603934|NCT02715726|2946188|Superiority||LS mean difference|-19.3|||<|0.0001|2-Sided|95.0|-22.1|-16.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603935|NCT02715726|2946189|Superiority||LS mean difference|-26.7|||<|0.0001|2-Sided|95.0|-30.5|-22.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603936|NCT02715726|2946190|Superiority||LS mean difference|-26.5|||<|0.0001|2-Sided|95.0|-29.8|-23.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603937|NCT02715726|2946191|Superiority||LS mean difference|-20.2|||<|0.0001|2-Sided|95.0|-23.1|-17.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603938|NCT02715726|2946192|Superiority||LS mean difference|-28.7|||<|0.0001|2-Sided|95.0|-32.6|-24.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603939|NCT02715726|2946193|Superiority||LS mean difference|-27.7|||<|0.0001|2-Sided|95.0|-31.8|-23.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603940|NCT02715726|2946194|Superiority||LS mean difference|-27.8|||<|0.0001|2-Sided|95.0|-31.2|-24.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603941|NCT02715726|2946195|Superiority|Threshold for significance at 0.05 level.|LS mean difference|-27.4|||<|0.0001|2-Sided|95.0|-30.8|-23.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603942|NCT02715726|2946196|Superiority||LS mean difference|-35.4|||<|0.0001|2-Sided|95.0|-40.0|-30.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603943|NCT02715726|2946197|Superiority||LS mean difference|-34.9|||<|0.0001|2-Sided|95.0|-39.5|-30.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1603944|NCT02715726|2946198|Superiority||LS mean difference|-37.3|||<|0.0001|2-Sided|95.0|-42.1|-32.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|A hierarchical testing method was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|
1603945|NCT02715726|2946199|Superiority||LS mean difference|-35.6|||<|0.0001|2-Sided|95.0|-40.6|-30.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.|
1603946|NCT02715700|2946201|Other|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||2-Sided|90.0|0.92|1.03|||||||
1603947|NCT02715700|2946202|Other|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.96|||||2-Sided|90.0|0.87|1.05|||||||
1603948|NCT02715700|2946203|Other|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.96|||||2-Sided|90.0|0.9|1.03|||||||
1603949|NCT02715700|2946205|Other|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.97|||||2-Sided|90.0|0.91|1.04|||||||
1603950|NCT02715700|2946206|Other|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.97|||||2-Sided|90.0|0.86|1.1|||||||
1603951|NCT02715700|2946207|Other|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||2-Sided|90.0|0.9|1.06|||||||
1603952|NCT02715700|2946209|Other|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.98|||||2-Sided|90.0|0.93|1.03|||||||
1603953|NCT02715700|2946210|Other|GMR of Methadone + Doravirine/Methadone Alone|GMR|0.95|||||2-Sided|90.0|0.88|1.03|||||||
1603954|NCT02715700|2946211|Other|Geometric mean ratio (GMR) of Methadone + Doravirine/Methadone Alone|GMR|0.95|||||2-Sided|90.0|0.9|1.01|||||||
1603955|NCT02714868|2946217|Other|||||||0.05|||||||t-test, 2 sided|||For goal attainment, we calculated independent t-tests to compare GAS t-scores across groups at outcome. Lowest score is 0, highest score is 100. 100 is highest goal attainment.|
1603974|NCT02714218|2946260|Superiority||Estimated Difference of rates|-12.7|||||2-Sided|95.0|-22.7|-2.6|||||Estimate of NIVO 3 + IPI 1- NIVO 1 + IPI 3 is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 expression and M stage at screening as entered into the IVRS||
1604025|NCT02713204|2946315|Superiority||Least square mean difference|-0.87||||0.339|2-Sided|95.0|-2.66|0.92||Threshold for significance at 0.05 level.|ANCOVA||||
1603956|NCT02714426|2946219|Other|||||||0.439||||||A priori threshold for statistical significance was set at p < .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,31) = 0.616, p = 0.439, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).|
1603957|NCT02714426|2946220|Other|||||||0.448||||||A priori threshold for statistical significance was set at p < .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,34) = 0.589, p = .0.448, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).|
1603958|NCT02714426|2946221|Other|||||||0.001||||||A priori threshold for statistical significance was set at p < .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-8) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,31.069) = 15.046, p = .001, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).|
1603959|NCT02714426|2946223|Other|||||||0.333||||||A priori threshold for statistical significance was set at p < .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,34) = 0.96, p = .333, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. Diagonal repeated covariance was best (heterogeneous variance over time, and no residual cross-time covariances).|
1603960|NCT02714426|2946224|Other|||||||0.024||||||A priori threshold for statistical significance was set at p < .05. No adjustment was made for multiple comparisons. The critical effect of interest evaluated here was the Linear Occasion (1-14) x Group (Brain Health vs. Mindfulness) interaction.|Mixed Models Analysis|F(1,33) = 5.57, p = .024, no adjustments.||Mixed effects models were used. Independent variables were linear and quadratic time/occasion, intervention group, and group-by-time interactions if appropriate. Preparatory to modeling, preliminary unconditional models were run to determine best fitting approaches for repeated and random covariance structures. First-order Autoregressive was best (which specifies homogeneous variance over time but allows one correlation between occasions).|
1603961|NCT02714283|2946230|Superiority||Hazard Ratio (HR)|1.15||||0.0005|2-Sided|95.0|1.07|1.25|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)||
1603962|NCT02714283|2946231|Superiority||Hazard Ratio (HR)|1.0||||0.99|2-Sided|95.0|0.66|1.51|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)||
1603963|NCT02714283|2946232|Superiority||Hazard Ratio (HR)|1.15|||<|0.0001|2-Sided|95.0|1.08|1.21|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)||
1603964|NCT02714283|2946233|Superiority||Hazard Ratio (HR)|1.09||||0.2|2-Sided|95.0|0.96|1.25|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)||
1603965|NCT02714283|2946234|Superiority||Hazard Ratio (HR)|0.9||||0.23|2-Sided|95.0|0.76|1.07|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)||
1603966|NCT02714283|2946235|Superiority||Hazard Ratio (HR)|1.02||||0.87|2-Sided|95.0|0.8|1.32|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)||
1603967|NCT02714283|2946236|Superiority||Hazard Ratio (HR)|0.73|||<|0.0001|2-Sided|95.0|0.64|0.82|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history|ICS (numerator) compared to macrolide monotherapy (denominator)||
1603968|NCT02714283|2946237|Superiority||Hazard Ratio (HR)|0.86||||0.21|2-Sided|95.0|0.67|1.09|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)||
1603969|NCT02714283|2946238|Superiority||Hazard Ratio (HR)|1.39|||<|0.0001|2-Sided|95.0|1.23|1.57|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use, and NTM history.|ICS (numerator) compared to macrolide monotherapy (denominator)||
1603970|NCT02714283|2946239|Superiority||Hazard Ratio (HR)|0.77||||0.19|2-Sided|95.0|0.51|1.14|||Regression, Cox|Adjusted for propensity score decile, oral corticosteroid use.|ICS (numerator) compared to macrolide monotherapy (denominator)|Due to the small sample size in the macrolide monotherapy group, for this outcome, the results are considered exploratory/descriptive only.|
1603971|NCT02714218|2946255|Superiority||Hazard Ratio (HR)|1.09||||0.7155|2-Sided|95.0|0.79|1.42|||Log Rank|Test stratified by PD-L1 expression and M stage at screening as entered into the IVRS|||
1603972|NCT02714218|2946258|Superiority||Hazard Ratio (HR)|1.09|||||2-Sided|95.0|0.73|1.62|||||Based on Kaplan-Meier Estimates||
1603973|NCT02714218|2946259|Superiority||Odds Ratio (OR)|0.82||||0.3451|2-Sided|95.0|0.54|124.0|||Cochran-Mantel-Haenszel||p-value from CMH Test for the comparison of the odds ratio of N3I1 over N1I3||
1604023|NCT02713243|2946310|Superiority||Mean Difference (Net)|4.04||||0.01|2-Sided|95.0|0.98|7.11|||Mixed Models Analysis|||Week 1 (Period 1 & 2)|
1603975|NCT02714218|2946260|Superiority||Odds Ratio (OR)|0.59||||0.0144|2-Sided|95.0|0.38|0.9|||Cochran-Mantel-Haenszel|Two-sided p-value CMH Test for comparison of odds ratio of NIVO 3 + IPI 1 over NIVO 1 + IPI 3|||
1603976|NCT02713789|2946282|Superiority|||||||0.16|||||||ANCOVA|||SEP5|
1603977|NCT02713789|2946282|Superiority|||||||0.337|||||||ANCOVA|||SEP4|
1603978|NCT02713789|2946282|Superiority|||||||0.369|||||||ANCOVA|||SEP4|
1603979|NCT02713789|2946282|Superiority|||||||0.498|||||||ANCOVA|||SEP1|
1603980|NCT02713789|2946282|Superiority|||||||0.136|||||||ANCOVA|||SEP1|
1603981|NCT02713789|2946283|Superiority|||||||0.235|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis|||
1603982|NCT02713789|2946283|Superiority|||||||0.493|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis|||
1603983|NCT02713789|2946283|Superiority|||||||0.109|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1603984|NCT02713789|2946283|Superiority|||||||0.468|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1603985|NCT02713789|2946283|Superiority|||||||0.074|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1603986|NCT02713789|2946284|Superiority|||||||0.09|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis|||
1603987|NCT02713789|2946284|Superiority|||||||0.05|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis|||
1603988|NCT02713789|2946284|Superiority|||||||0.011|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1603989|NCT02713789|2946284|Superiority|||||||0.381|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1603990|NCT02713789|2946284|Superiority|||||||0.449|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1603991|NCT02713789|2946285|Superiority|||||||0.286|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis|||
1603992|NCT02713789|2946285|Superiority|||||||0.296|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis|||
1603993|NCT02713789|2946285|Superiority|||||||0.5|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1603994|NCT02713789|2946285|Superiority|||||||0.203|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1603995|NCT02713789|2946285|Superiority|||||||0.199|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1603996|NCT02713789|2946286|Superiority|||||||0.172|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis|||
1603997|NCT02713789|2946286|Superiority|||||||0.221|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis|||
1603998|NCT02713789|2946286|Superiority|||||||0.316|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1603999|NCT02713789|2946286|Superiority|||||||0.208|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1604000|NCT02713789|2946286|Superiority|||||||0.16|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1604001|NCT02713789|2946287|Superiority|||||||0.123|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis|||
1604002|NCT02713789|2946287|Superiority|||||||0.137|||||||t-test, 1 sided|p-value (one-sided) corresponds to the two sample t-test analysis|||
1604003|NCT02713789|2946287|Superiority|||||||0.022|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1604004|NCT02713789|2946287|Superiority|||||||0.144|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1604005|NCT02713789|2946287|Superiority|||||||0.384|||||||t-test, 1 sided|one-sided paired t-test at 5% significance level|||
1604006|NCT02713789|2946288|Superiority|||||||0.766|||||||ANCOVA|||SEP3|
1604007|NCT02713789|2946288|Superiority|||||||0.274|||||||ANCOVA|||SEP3|
1604008|NCT02713789|2946288|Superiority|||||||0.594|||||||ANCOVA|||SEP2|
1604009|NCT02713789|2946288|Superiority|||||||0.827|||||||ANCOVA|||SEP2|
1604010|NCT02713659|2946293|Equivalence|0.05||||||0.71|||||||Chi-squared|||Number of up to date child vaccinations between the early literacy arm and the standard literacy arm at 6 months of age|
1604011|NCT02713659|2946293|Equivalence|0.05||||||0.23|||||||Chi-squared|||Number of up to date child well visits between the early literacy arm and the standard literacy arm at 6 months of age|
1604012|NCT02713659|2946294|Equivalence|0.05||||||0.57|||||||t-test, 2 sided|||Total read scale score between infants at 6 months and 24 months of age in the early literacy arm and the standard literacy arm|
1604013|NCT02713659|2946295|Equivalence|0.05||||||0.49|||||||t-test, 2 sided|||Total standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm|
1604014|NCT02713659|2946295|Equivalence|0.05||||||0.53|||||||t-test, 2 sided|||Expressive standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm|
1604015|NCT02713659|2946295|Equivalence|0.05||||||0.85|||||||t-test, 2 sided|||Auditory standard score between infants at 6 months and 24 months of age in the Early literacy arm and the standard literacy arm|
1604016|NCT02713594|2946297|Superiority or Other||||||<|0.0001|||||||Chi-squared|Chi-square test value = 196.1, with 5 degrees of freedom.|||
1604017|NCT02713594|2946298|Superiority or Other||Risk Difference (RD)|-7.86|||<|0.0001|2-Sided|95.0|-11.28|-4.5|||Abstinence Risk Difference||||
1604018|NCT02713243|2946305|Superiority||Mean Difference (Net)|0.02||||0.916|2-Sided|95.0|-0.27|0.3|||Mixed Models Analysis|||Week 1&2 (Period 1 & 2)|
1604019|NCT02713243|2946305|Superiority||Mean Difference (Net)|-0.09||||0.64|2-Sided|95.0|-0.49|0.3|||Mixed Models Analysis|||Week 2 (Period 1 & 2)|
1604020|NCT02713243|2946305|Superiority||Mean Difference (Net)|0.12||||0.533|2-Sided|95.0|-0.27|0.52|||Mixed Models Analysis|||Week 1 (Period 1 & 2)|
1604021|NCT02713243|2946310|Superiority||Mean Difference (Net)|2.67||||0.019|2-Sided|95.0|0.46|4.89|||Mixed Models Analysis|||Week 1&2 (Period 1 & 2)|
1604022|NCT02713243|2946310|Superiority||Mean Difference (Net)|1.31||||0.401|2-Sided|95.0|-1.77|4.38|||Mixed Models Analysis|||Week 2 (Period 1 & 2)|
1604100|NCT02712554|2946333|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment D (high-dose M366) - Placebo|
1604026|NCT02713204|2946315|Superiority||Least square mean difference|-1.02||||0.2581|2-Sided|95.0|-2.78|0.75||Threshold for significance at 0.05 level.|ANCOVA||||
1604027|NCT02713204|2946315|Superiority||Least square mean difference|-0.97||||0.2819|2-Sided|95.0|-2.73|0.8||Threshold for significance at 0.05 level.|ANCOVA||||
1604028|NCT02713204|2946315|Superiority||Least square mean difference|-1.41||||0.1238|2-Sided|95.0|-3.2|0.39||Threshold for significance at 0.05 level.|ANCOVA||||
1604029|NCT02713204|2946315|Superiority||Least square mean difference|-0.1||||0.918|2-Sided|95.0|-1.91|1.72||Threshold for significance at 0.05 level.|ANCOVA||||
1604030|NCT02713204|2946315|Superiority||Least square mean difference|-0.19||||0.8383|2-Sided|95.0|-1.99|1.62||Threshold for significance at 0.05 level.|ANCOVA||||
1604031|NCT02713204|2946316|Superiority||Least square mean difference|-0.22||||0.7418|2-Sided|95.0|-1.55|1.1||Threshold for significance at 0.05 level.|ANCOVA||||
1604032|NCT02713204|2946316|Superiority||Least square mean difference|0.57||||0.5065|2-Sided|95.0|-1.11|2.25||Threshold for significance at 0.05 level.|ANCOVA||||
1604033|NCT02713204|2946317|Superiority||Least square mean difference|0.21||||0.8056|2-Sided|95.0|-1.46|1.88||Threshold for significance at 0.05 level.|ANCOVA||||
1604034|NCT02713204|2946317|Superiority||Least square mean difference|-0.98||||0.2632|2-Sided|95.0|-2.7|0.74||Threshold for significance at 0.05 level.|ANCOVA||||
1604035|NCT02713204|2946317|Superiority||Least square mean difference|-0.8||||0.3504|2-Sided|95.0|-2.5|0.89||Threshold for significance at 0.05 level.|ANCOVA||||
1604036|NCT02713204|2946317|Superiority||Least square mean difference|-0.6||||0.4898|2-Sided|95.0|-2.29|1.1||Threshold for significance at 0.05 level.|ANCOVA||||
1604037|NCT02713204|2946317|Superiority||Least square mean difference|-0.89||||0.3091|2-Sided|95.0|-2.61|0.83||Threshold for significance at 0.05 level.|ANCOVA||||
1604038|NCT02713204|2946317|Superiority||Least square mean difference|0.38||||0.6645|2-Sided|95.0|-1.36|2.13||Threshold for significance at 0.05 level.|ANCOVA||||
1604039|NCT02713204|2946317|Superiority||Least square mean difference|-0.6||||0.4927|2-Sided|95.0|-2.34|1.13||Threshold for significance at 0.05 level.|ANCOVA||||
1604040|NCT02713204|2946318|Superiority||Least square mean difference|0.24||||0.7027|2-Sided|95.0|-0.99|1.46||Threshold for significance at 0.05 level.|ANCOVA||||
1604041|NCT02713204|2946318|Superiority||Least square mean difference|0.55||||0.4889|2-Sided|95.0|-1.01|2.1||Threshold for significance at 0.05 level.|ANCOVA||||
1604042|NCT02713204|2946319|Superiority||Least square mean difference|-8.38||||0.6586|2-Sided|95.0|-45.64|28.88||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604043|NCT02713204|2946319|Superiority||Least square mean difference|21.05||||0.279|2-Sided|95.0|-17.13|59.22||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604044|NCT02713204|2946319|Superiority||Least square mean difference|16.65||||0.3934|2-Sided|95.0|-21.67|54.96||Threshold for significance at 0.05 level.|ANCOVA||||
1604045|NCT02713204|2946319|Superiority||Least square mean difference|42.27||||0.0281|2-Sided|95.0|4.56|79.98||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604046|NCT02713204|2946319|Superiority||Least square mean difference|33.89||||0.0785|2-Sided|95.0|-3.89|71.67|||ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604047|NCT02713204|2946319|Superiority||Least square mean difference|12.85||||0.5141|2-Sided|95.0|-25.84|51.53||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604048|NCT02713204|2946319|Superiority||Least square mean difference|17.04||||0.3833|2-Sided|95.0|-21.35|55.43||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604049|NCT02713204|2946320|Superiority||Least square mean difference|-4.88||||0.6587|2-Sided|95.0|-26.2|16.85|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|
1604050|NCT02713204|2946320|Superiority||Least square mean difference|-11.57||||0.413|2-Sided|95.0|-39.5|16.2||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|
1604051|NCT02713204|2946321|Superiority||Least square mean difference|2.42||||0.1267|2-Sided|95.0|-0.69|5.54||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604052|NCT02713204|2946321|Superiority||Least square mean difference|1.17||||0.469|2-Sided|95.0|-2.01|4.36||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604053|NCT02713204|2946321|Superiority||Least square mean difference|-4.39||||0.0073|2-Sided|95.0|-7.58|-1.19||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604054|NCT02713204|2946321|Superiority||Least square mean difference|-3.25||||0.0426|2-Sided|95.0|-6.39|-0.11||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604055|NCT02713204|2946321|Superiority||Least square mean difference|-0.82||||0.6063|2-Sided|95.0|-3.97|2.32||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604099|NCT02712554|2946333|Superiority or Other (legacy)||||||<|0.2706|||||||ANOVA|||TA_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604056|NCT02713204|2946321|Superiority|Threshold for significance at 0.05 level.|Least square mean difference|-2.0||||0.2225|2-Sided|95.0|-5.22|1.22|||ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604057|NCT02713204|2946321|Superiority||Least square mean difference|-1.2||||0.4611|2-Sided|95.0|-4.41|2.0||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604058|NCT02713204|2946322|Superiority||Least square mean difference|0.25||||0.8346|2-Sided|95.0|-2.09|2.59|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|
1604059|NCT02713204|2946322|Superiority|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|Least square mean difference|0.02||||0.9894|2-Sided|95.0|-2.99|3.03||Threshold for significance at 0.05 level.|ANCOVA||||
1604060|NCT02712554|2946325|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo|
1604061|NCT02712554|2946325|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo|
1604062|NCT02712554|2946325|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment B (high-dose CL-108) – Treatment D (high-dose M366)|
1604063|NCT02712554|2946325|Superiority or Other (legacy)||||||<|0.012|||||||ANOVA|||TA_AUE0-8hr: Treatment A (low-dose CL-108) – Treatment C (low-dose M366)|
1604064|NCT02712554|2946325|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment D (high-dose M366) - Placebo|
1604065|NCT02712554|2946325|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment C (low-dose M366) – Placebo|
1604066|NCT02712554|2946326|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||MPC: Treatment B (high-dose CL-108) - Placebo|
1604067|NCT02712554|2946326|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||MPC: Treatment A (low-dose CL-108) - Placebo|
1604068|NCT02712554|2946326|Superiority or Other (legacy)||||||<|0.0014|||||||ANOVA|||MPC: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604069|NCT02712554|2946326|Superiority or Other (legacy)||||||<|0.1268|||||||ANOVA|||MPC: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604070|NCT02712554|2946326|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Treatment D: M366 37.5 mg/1625 mg, Treatment E: Placebo|
1604071|NCT02712554|2946326|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||MPC: Treatment C (low-dose M366) - Placebo|
1604072|NCT02712554|2946329|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo|
1604073|NCT02712554|2946329|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo|
1604074|NCT02712554|2946329|Superiority or Other (legacy)||||||<|0.1808|||||||ANOVA|||TA_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604075|NCT02712554|2946329|Superiority or Other (legacy)||||||<|0.2335|||||||ANOVA|||TA_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604076|NCT02712554|2946329|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment D (high-dose M366) - Placebo|
1604077|NCT02712554|2946329|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment C (low-dose M366) - Placebo|
1604078|NCT02712554|2946330|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo|
1604079|NCT02712554|2946330|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo|
1604080|NCT02712554|2946330|Superiority or Other (legacy)||||||<|0.4436|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604081|NCT02712554|2946330|Superiority or Other (legacy)||||||<|0.063|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604082|NCT02712554|2946330|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo|
1604083|NCT02712554|2946330|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo|
1604084|NCT02712554|2946331|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo|
1604085|NCT02712554|2946331|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo|
1604086|NCT02712554|2946331|Superiority or Other (legacy)||||||<|0.0011|||||||ANOVA|||TA_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604087|NCT02712554|2946331|Superiority or Other (legacy)||||||<|0.0037|||||||ANOVA|||TA_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604088|NCT02712554|2946331|Superiority or Other (legacy)||||||<|0.0012|||||||ANOVA|||TA_AUE0-8hr: Treatment D (high-dose M366) - Placebo|
1604089|NCT02712554|2946331|Superiority or Other (legacy)||||||<|0.0024|||||||ANOVA|||TA_AUE0-8hr: Treatment C (low-dose M366) - Placebo|
1604090|NCT02712554|2946332|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Placebo|
1604091|NCT02712554|2946332|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo|
1604092|NCT02712554|2946332|Superiority or Other (legacy)||||||<|0.008|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604093|NCT02712554|2946332|Superiority or Other (legacy)||||||<|0.0014|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604094|NCT02712554|2946332|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emin: Treatment D (high-dose M366) – Placebo|
1604095|NCT02712554|2946332|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emin: Treatment C (low-dose M366) – Placebo|
1604096|NCT02712554|2946333|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo|
1604097|NCT02712554|2946333|Superiority or Other (legacy)||||||<|0.0047|||||||ANOVA|||TA_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo|
1604098|NCT02712554|2946333|Superiority or Other (legacy)||||||<|0.5507|||||||ANOVA|||TA_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604101|NCT02712554|2946333|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment C (low-dose M366) - Placebo|
1604102|NCT02712554|2946334|Superiority or Other (legacy)||||||<|0.001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo|
1604103|NCT02712554|2946334|Superiority or Other (legacy)||||||<|0.0041|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo|
1604104|NCT02712554|2946334|Superiority or Other (legacy)||||||<|0.1638|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604105|NCT02712554|2946334|Superiority or Other (legacy)||||||<|0.2223|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604106|NCT02712554|2946334|Superiority or Other (legacy)||||||<|0.001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo|
1604107|NCT02712554|2946334|Superiority or Other (legacy)||||||<|0.001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo|
1604108|NCT02712554|2946335|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo|
1604109|NCT02712554|2946335|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo|
1604110|NCT02712554|2946335|Superiority or Other (legacy)||||||<|0.0736|||||||ANOVA|||TA_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604111|NCT02712554|2946335|Superiority or Other (legacy)||||||<|0.4013|||||||ANOVA|||TA_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604112|NCT02712554|2946335|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment D (high-dose M366) - Placebo|
1604113|NCT02712554|2946335|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment C (low-dose M366) - Placebo|
1604114|NCT02712554|2946336|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo|
1604115|NCT02712554|2946336|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo|
1604116|NCT02712554|2946336|Superiority or Other (legacy)||||||<|0.1751|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604117|NCT02712554|2946336|Superiority or Other (legacy)||||||<|0.1839|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604118|NCT02712554|2946336|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo|
1604119|NCT02712554|2946336|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo|
1604120|NCT02712554|2946337|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment B (high-dose CL-108) - Placebo|
1604121|NCT02712554|2946337|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment A (low-dose CL-108) - Placebo|
1604122|NCT02712554|2946337|Superiority or Other (legacy)||||||<|0.2262|||||||ANOVA|||TA_AUE0-8hr: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604123|NCT02712554|2946337|Superiority or Other (legacy)||||||<|0.2628|||||||ANOVA|||TA_AUE0-8hr: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604124|NCT02712554|2946337|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment D (high-dose M366) - Placebo|
1604125|NCT02712554|2946337|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||TA_AUE0-8hr: Treatment C (low-dose M366) - Placebo|
1604126|NCT02712554|2946338|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo|
1604127|NCT02712554|2946338|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo|
1604128|NCT02712554|2946338|Superiority or Other (legacy)||||||<|0.3184|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604129|NCT02712554|2946338|Superiority or Other (legacy)||||||<|0.4025|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604130|NCT02712554|2946338|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo|
1604131|NCT02712554|2946338|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo|
1604132|NCT02712554|2946339|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Placebo|
1604133|NCT02712554|2946339|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo|
1604134|NCT02712554|2946339|Superiority or Other (legacy)||||||<|0.0575|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604135|NCT02712554|2946339|Superiority or Other (legacy)||||||<|0.113|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604136|NCT02712554|2946339|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo|
1604137|NCT02712554|2946339|Superiority or Other (legacy)||||||<|0.0009|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo|
1604138|NCT02712554|2946339|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo|
1604139|NCT02712554|2946339|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo|
1604140|NCT02712554|2946339|Superiority or Other (legacy)||||||<|0.2877|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604141|NCT02712554|2946339|Superiority or Other (legacy)||||||<|0.0858|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604142|NCT02712554|2946339|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo|
1604143|NCT02712554|2946339|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo|
1604144|NCT02712554|2946340|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA||||
1604145|NCT02712554|2946340|Superiority or Other (legacy)||||||<|0.0002|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Placebo|
1604146|NCT02712554|2946340|Superiority or Other (legacy)||||||<|0.0318|||||||ANOVA|||Emin: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604147|NCT02712554|2946340|Superiority or Other (legacy)||||||<|0.1679|||||||ANOVA|||Emin: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604148|NCT02712554|2946340|Superiority or Other (legacy)||||||<|0.0025|||||||ANOVA|||Emin: Treatment D (high-dose M366) - Placebo|
1604149|NCT02712554|2946340|Superiority or Other (legacy)||||||<|0.0119|||||||ANOVA|||Emin: Treatment C (low-dose M366) - Placebo|
1604150|NCT02712554|2946340|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Placebo|
1604151|NCT02712554|2946340|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Placebo|
1604152|NCT02712554|2946340|Superiority or Other (legacy)||||||<|0.1767|||||||ANOVA|||Emax: Treatment B (high-dose CL-108) - Treatment D (high-dose M366)|
1604153|NCT02712554|2946340|Superiority or Other (legacy)||||||<|0.1267|||||||ANOVA|||Emax: Treatment A (low-dose CL-108) - Treatment C (low-dose M366)|
1604154|NCT02712554|2946340|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment D (high-dose M366) - Placebo|
1604155|NCT02712554|2946340|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA|||Emax: Treatment C (low-dose M366) - Placebo|
1604156|NCT02712554|2946344|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA||||
1604157|NCT02712554|2946344|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA||||
1604158|NCT02712554|2946344|Superiority or Other (legacy)||||||<|0.4737|||||||ANOVA||||
1604159|NCT02712554|2946344|Superiority or Other (legacy)||||||<|0.2344|||||||ANOVA||||
1604160|NCT02712554|2946344|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA||||
1604161|NCT02712554|2946344|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA||||
1604162|NCT02712359|2946347|Non-Inferiority|The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose_Year 10 Group minus Havrix 2 doses_Year 10 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.|Difference in seropositivity rate|-24.43|||<|0.0001|2-Sided|95.0|-30.11|-19.03|||Fisher Exact|||Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose_Year 10 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses_Year 10 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 10 years after the administration of the last vaccine dose.|
1604163|NCT02712359|2946348|Non-Inferiority|The lower limit of the 2-sided 95% confidence interval (CI) for the difference (Havrix 1 dose_Year 8 Group minus Havrix 2 doses_Year 8 Group) of percentage of subjects with anti-HAV antibody concentrations ≥ 15 mIU/mL was to be greater than or equal to the pre-defined clinical non-inferiority limit of -10%.|Difference in seropositivity rate|-23.33|||<|0.0001|2-Sided|95.0|-28.78|-18.29|||Fisher Exact|||Difference in seropositivity rates for anti-HAV antibody: To demonstrate that 1-dose schedule of Havrix (Havrix 1 dose_Year 8 Group) was non-inferior to the 2-dose schedule of Havrix (Havrix 2 doses_Year 8 Group), in terms of seropositivity rates for anti-HAV antibody, measured by ELISA, approximately 8 years after the administration of the last vaccine dose.|
1604164|NCT02712333|2946353|Superiority or Other||% increase per 10μg/m3 increase of PM2.5|1.24|||>|0.05|2-Sided|95.0|-1.14|3.63|||Mixed Models Analysis|||we analyzed the serum cortisol levels by treatment (intervention group vs control group)|
1604165|NCT02712333|2946354|Superiority or Other||% increase per 10μg/m3 increase of PM2.5|0.31|||>|0.05|2-Sided|95.0|-1.59|0.96|||Mixed Models Analysis|||we analyzed the serum cortisol levels by treatment (intervention group vs control group)|
1604166|NCT02712333|2946355|Superiority or Other||% increase per 10μg/m3 increase of PM2.5|0.84|||<|0.01|2-Sided|95.0|0.09|1.59|||Mixed Models Analysis|||we analyzed the serum SBP levels by treatment (intervention group vs control group)|
1604167|NCT02712333|2946356|Superiority or Other||fold change|1.57|||<|0.01|2-Sided||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group||
1604168|NCT02712333|2946356|Superiority or Other||% increase per 10μg/m3 increase of PM2.5|11.28|||<|0.01|2-Sided|95.0|7.37|15.21||the p-value has been adjusted for multiple comparisons|Mixed Models Analysis|||we analyzed the serum norepinephrine levels by treatment (intervention group vs control group)|
1604169|NCT02712333|2946357|Superiority or Other||fold change|1.2|||<|0.01|2-Sided||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group||
1604170|NCT02712333|2946357|Superiority or Other||% increase per 10μg/m3 increase of PM2.5|5.17|||<|0.01|2-Sided|95.0|3.21|7.14||the p-value has been adjusted for multiple comparisons.|Mixed Models Analysis|||we analyzed the serum epinephrine levels by treatment (intervention group vs control group)|
1604171|NCT02712333|2946358|Superiority or Other||fold change|1.18|||<|0.01|2-Sided||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group||
1604172|NCT02712333|2946358|Superiority or Other||% increase per 10μg/m3 increase of PM2.5|3.69|||<|0.01|2-Sided|95.0|1.85|5.54||the p-value has been adjusted for multiple comparisons.|Mixed Models Analysis|||we analyzed the serum cortisone levels by treatment (intervention group vs control group)|
1604173|NCT02712333|2946359|Superiority or Other||fold change|1.33|||<|0.01|2-Sided||||||t-test, 2 sided||fold change is calculated by measurments from the sham purification group/measurements from the real purification group||
1604174|NCT02712333|2946359|Superiority or Other||% increase per 10μg/m3 increase of PM2.5|7.53|||<|0.05|2-Sided|95.0|4.65|10.41||the p-value has been adjusted for multiple comparisons|Mixed Models Analysis|||we analyzed the serum cortisol levels (presented as relative intensities in high perfomance liquid chromatography-mass spectrum) by treatments (intervention group vs control group)|
1604175|NCT02712047|2946371|Other||Mean Difference (Net)|0.03|||||2-Sided|95.0|-0.07|0.13|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, AM||
1604176|NCT02712047|2946371|Other||Mean Difference (Net)|0.04|||||2-Sided|95.0|-0.06|0.14|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, AM||
1604177|NCT02712047|2946371|Other||Mean Difference (Net)|0.07|||||2-Sided|95.0|-0.03|0.17|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, AM||
1604178|NCT02712047|2946371|Other||Mean Difference (Net)|0.17|||||2-Sided|95.0|0.07|0.27|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, PM||
1604179|NCT02712047|2946371|Other||Mean Difference (Net)|0.24|||||2-Sided|95.0|0.14|0.34|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, AM||
1604180|NCT02712047|2946371|Other||Mean Difference (Net)|0.18|||||2-Sided|95.0|0.08|0.28|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, PM||
1605949|NCT02669407|2949195|Other|Single group|||||<|0.001|||||||Tukey's method||||
1604181|NCT02712047|2946371|Other||Mean Difference (Net)|0.26|||||2-Sided|95.0|0.16|0.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, AM||
1604182|NCT02712047|2946371|Other||Mean Difference (Net)|0.24|||||2-Sided|95.0|0.14|0.34|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, PM||
1604183|NCT02712047|2946371|Other||Mean Difference (Net)|0.34|||||2-Sided|95.0|0.24|0.44|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, AM||
1604184|NCT02712047|2946371|Other||Mean Difference (Net)|0.26|||||2-Sided|95.0|0.16|0.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, PM||
1604185|NCT02712047|2946371|Other||Mean Difference (Net)|0.36|||||2-Sided|95.0|0.26|0.46|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, AM||
1604186|NCT02712047|2946372|Other||Mean Difference (Net)|5.19|||||2-Sided|95.0|-45.35|55.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, PM||
1604187|NCT02712047|2946372|Other||Mean Difference (Net)|15.08|||||2-Sided|95.0|-28.5|58.67|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 21, AM||
1604188|NCT02712047|2946372|Other||Mean Difference (Net)|8.51|||||2-Sided|95.0|-37.22|54.25|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 20, PM||
1604189|NCT02712047|2946372|Other||Mean Difference (Net)|-7.89|||||2-Sided|95.0|-48.04|32.25|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 20, AM||
1604190|NCT02712047|2946372|Other||Mean Difference (Net)|25.13|||||2-Sided|95.0|-15.02|65.27|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 19, PM||
1604191|NCT02712047|2946372|Other||Mean Difference (Net)|20.11|||||2-Sided|95.0|-12.3|52.52|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 19, AM||
1604192|NCT02712047|2946372|Other||Mean Difference (Net)|47.04|||||2-Sided|95.0|14.63|79.45|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 18, PM||
1604193|NCT02712047|2946372|Other||Mean Difference (Net)|24.77|||||2-Sided|95.0|-4.2|53.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 18, AM||
1604194|NCT02712047|2946372|Other||Mean Difference (Net)|9.64|||||2-Sided|95.0|-17.91|37.19|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 17, PM||
1604195|NCT02712047|2946372|Other||Mean Difference (Net)|29.51|||||2-Sided|95.0|6.87|52.15|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 17, AM||
1604196|NCT02712047|2946372|Other||Mean Difference (Net)|19.07|||||2-Sided|95.0|-3.27|41.41|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 16, PM||
1604197|NCT02712047|2946372|Other||Mean Difference (Net)|6.35|||||2-Sided|95.0|-16.17|28.88|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 16, AM||
1604198|NCT02712047|2946372|Other||Mean Difference (Net)|18.87|||||2-Sided|95.0|-3.89|41.63|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 15, PM||
1604199|NCT02712047|2946372|Other||Mean Difference (Net)|4.1|||||2-Sided|95.0|-18.16|26.36|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 15, AM||
1604200|NCT02712047|2946372|Other||Mean Difference (Net)|12.31|||||2-Sided|95.0|-10.13|34.74|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 14, PM||
1604201|NCT02712047|2946372|Other||Mean Difference (Net)|28.45|||||2-Sided|95.0|5.76|51.13|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 14, AM||
1604202|NCT02712047|2946372|Other||Mean Difference (Net)|-6.88|||||2-Sided|95.0|-29.96|16.19|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 13, PM||
1604203|NCT02712047|2946372|Other||Mean Difference (Net)|0.64|||||2-Sided|95.0|-21.64|22.92|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 13, AM||
1604204|NCT02712047|2946372|Other||Mean Difference (Net)|8.29|||||2-Sided|95.0|-13.99|30.57|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 12, PM||
1604205|NCT02712047|2946372|Other||Mean Difference (Net)|4.36|||||2-Sided|95.0|-18.39|27.11|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 12, AM||
1604206|NCT02712047|2946372|Other||Mean Difference (Net)|-6.62|||||2-Sided|95.0|-28.8|15.55|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 11, PM||
1604207|NCT02712047|2946372|Other||Mean Difference (Net)|14.71|||||2-Sided|95.0|-7.57|36.98|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 11, AM||
1604208|NCT02712047|2946372|Other||Mean Difference (Net)|27.73|||||2-Sided|95.0|5.43|50.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 10, PM||
1604209|NCT02712047|2946372|Other||Mean Difference (Net)|11.36|||||2-Sided|95.0|-11.11|33.82|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 10, AM||
1604210|NCT02712047|2946372|Other||Mean Difference (Net)|3.83|||||2-Sided|95.0|-18.34|26.0|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 9, PM||
1604211|NCT02712047|2946372|Other||Mean Difference (Net)|3.32|||||2-Sided|95.0|-19.11|25.74|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 9, AM||
1604212|NCT02712047|2946372|Other||Mean Difference (Net)|7.5|||||2-Sided|95.0|-14.67|29.68|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 8, PM||
1604213|NCT02712047|2946372|Other||Mean Difference (Net)|12.87|||||2-Sided|95.0|-9.3|35.05|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 8, AM||
1604214|NCT02712047|2946372|Other||Mean Difference (Net)|23.61|||||2-Sided|95.0|0.28|46.94|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, PM||
1604215|NCT02712047|2946372|Other||Mean Difference (Net)|17.09|||||2-Sided|95.0|-5.08|39.26|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 7, AM||
1604216|NCT02712047|2946372|Other||Mean Difference (Net)|28.68|||||2-Sided|95.0|5.38|51.98|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 6, PM||
1604217|NCT02712047|2946372|Other||Mean Difference (Net)|13.05|||||2-Sided|95.0|-9.57|35.67|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 6, AM||
1604218|NCT02712047|2946372|Other||Mean Difference (Net)|21.86|||||2-Sided|95.0|-0.41|44.14|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, PM||
1604219|NCT02712047|2946372|Other||Mean Difference (Net)|16.82|||||2-Sided|95.0|-5.47|39.11|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 5, AM||
1604220|NCT02712047|2946372|Other||Mean Difference (Net)|20.85|||||2-Sided|95.0|-1.32|43.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, PM||
1604221|NCT02712047|2946372|Other||Mean Difference (Net)|19.33|||||2-Sided|95.0|-3.0|41.66|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 4, AM||
1604222|NCT02712047|2946372|Other||Mean Difference (Net)|36.94|||||2-Sided|95.0|14.77|59.12|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, PM||
1604223|NCT02712047|2946372|Other||Mean Difference (Net)|22.86|||||2-Sided|95.0|0.68|45.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 3, AM||
1604274|NCT02712047|2946374|Other||Ratio|0.36|||||2-Sided|95.0|0.31|0.43|||||Ratio of FF/VI 100/25mcg versus (Vs) Placebo for Day 1, AM||
1604224|NCT02712047|2946372|Other||Mean Difference (Net)|31.56|||||2-Sided|95.0|9.38|53.73|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, PM||
1604225|NCT02712047|2946372|Other||Mean Difference (Net)|34.03|||||2-Sided|95.0|11.86|56.21|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 2, AM||
1604226|NCT02712047|2946372|Other||Mean Difference (Net)|45.37|||||2-Sided|95.0|23.2|67.55|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, PM||
1604227|NCT02712047|2946372|Other||Mean Difference (Net)|45.86|||||2-Sided|95.0|23.69|68.03|||||Difference of FF/VI 100/25mcg Vs Placebo for Day 1, AM||
1604228|NCT02712047|2946374|Other||Ratio|0.72|||||2-Sided|95.0|0.32|1.64|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 24, AM||
1604229|NCT02712047|2946374|Other||Ratio|0.67|||||2-Sided|95.0|0.29|1.51|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 23, PM||
1604230|NCT02712047|2946374|Other||Ratio|0.99|||||2-Sided|95.0|0.66|1.49|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 23, AM||
1604231|NCT02712047|2946374|Other||Ratio|0.77|||||2-Sided|95.0|0.51|1.16|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 22, PM||
1604232|NCT02712047|2946374|Other||Ratio|0.83|||||2-Sided|95.0|0.55|1.25|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 22, AM||
1604233|NCT02712047|2946374|Other||Ratio|0.75|||||2-Sided|95.0|0.5|1.13|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 21, PM||
1604234|NCT02712047|2946374|Other||Ratio|0.85|||||2-Sided|95.0|0.59|1.22|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 21, AM||
1604235|NCT02712047|2946374|Other||Ratio|0.78|||||2-Sided|95.0|0.53|1.14|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 20, PM||
1604236|NCT02712047|2946374|Other||Ratio|0.78|||||2-Sided|95.0|0.56|1.09|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 20, AM||
1604237|NCT02712047|2946374|Other||Ratio|0.72|||||2-Sided|95.0|0.52|1.0|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 19, PM||
1604238|NCT02712047|2946374|Other||Ratio|0.81|||||2-Sided|95.0|0.63|1.05|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 19, AM||
1604239|NCT02712047|2946374|Other||Ratio|0.77|||||2-Sided|95.0|0.59|1.0|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 18, PM||
1604240|NCT02712047|2946374|Other||Ratio|0.77|||||2-Sided|95.0|0.61|0.96|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 18, AM||
1604241|NCT02712047|2946374|Other||Ratio|0.81|||||2-Sided|95.0|0.65|1.01|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 17, PM||
1604242|NCT02712047|2946374|Other||Ratio|0.77|||||2-Sided|95.0|0.65|0.91|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 17, AM||
1604243|NCT02712047|2946374|Other||Ratio|0.73|||||2-Sided|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 16, PM||
1604244|NCT02712047|2946374|Other||Ratio|0.74|||||2-Sided|95.0|0.62|0.87|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 16, AM||
1604245|NCT02712047|2946374|Other||Ratio|0.79|||||2-Sided|95.0|0.66|0.94|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 15, PM||
1604246|NCT02712047|2946374|Other||Ratio|0.79|||||2-Sided|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 15, AM||
1604247|NCT02712047|2946374|Other||Ratio|0.67|||||2-Sided|95.0|0.56|0.79|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 14, PM||
1604248|NCT02712047|2946374|Other||Ratio|0.79|||||2-Sided|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 14, AM||
1604249|NCT02712047|2946374|Other||Ratio|0.78|||||2-Sided|95.0|0.66|0.93|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 13, PM||
1604250|NCT02712047|2946374|Other||Ratio|0.72|||||2-Sided|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 13, AM||
1604251|NCT02712047|2946374|Other||Ratio|0.71|||||2-Sided|95.0|0.6|0.84|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 12, PM||
1604252|NCT02712047|2946374|Other||Ratio|0.72|||||2-Sided|95.0|0.61|0.85|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 12, AM||
1604253|NCT02712047|2946374|Other||Ratio|0.73|||||2-Sided|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 11, PM||
1604254|NCT02712047|2946374|Other||Ratio|0.73|||||2-Sided|95.0|0.61|0.86|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 11, AM||
1604255|NCT02712047|2946374|Other||Ratio|0.68|||||2-Sided|95.0|0.58|0.81|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 10, PM||
1604256|NCT02712047|2946374|Other||Ratio|0.66|||||2-Sided|95.0|0.55|0.78|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 10, AM||
1604257|NCT02712047|2946374|Other||Ratio|0.68|||||2-Sided|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 9, PM||
1604258|NCT02712047|2946374|Other||Ratio|0.66|||||2-Sided|95.0|0.56|0.78|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 9, AM||
1604259|NCT02712047|2946374|Other||Ratio|0.68|||||2-Sided|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, PM||
1604260|NCT02712047|2946374|Other||Ratio|0.69|||||2-Sided|95.0|0.58|0.81|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, AM||
1604261|NCT02712047|2946374|Other||Ratio|0.62|||||2-Sided|95.0|0.52|0.74|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 7, PM|Ratio of FF/VI 100/25mcg Vs Placebo for Day 8, AM|
1604262|NCT02712047|2946374|Other||Ratio|0.6|||||2-Sided|95.0|0.51|0.71|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 7, AM||
1604263|NCT02712047|2946374|Other||Ratio|0.62|||||2-Sided|95.0|0.52|0.74|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 6, PM||
1604264|NCT02712047|2946374|Other||Ratio|0.67|||||2-Sided|95.0|0.56|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 6, AM||
1604265|NCT02712047|2946374|Other||Ratio|0.67|||||2-Sided|95.0|0.57|0.8|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 5, PM||
1604266|NCT02712047|2946374|Other||Ratio|0.63|||||2-Sided|95.0|0.53|0.75|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 5, AM||
1604267|NCT02712047|2946374|Other||Ratio|0.58|||||2-Sided|95.0|0.49|0.69|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 4, PM||
1604268|NCT02712047|2946374|Other||Ratio|0.56|||||2-Sided|95.0|0.47|0.66|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 4, AM||
1604269|NCT02712047|2946374|Other||Ratio|0.47|||||2-Sided|95.0|0.4|0.56|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 3, PM||
1604270|NCT02712047|2946374|Other||Ratio|0.46|||||2-Sided|95.0|0.39|0.54|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 3, AM||
1604271|NCT02712047|2946374|Other||Ratio|0.37|||||2-Sided|95.0|0.31|0.44|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 2, PM||
1604272|NCT02712047|2946374|Other||Ratio|0.38|||||2-Sided|95.0|0.32|0.45|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 2, AM||
1604273|NCT02712047|2946374|Other||Ratio|0.33|||||2-Sided|95.0|0.28|0.39|||||Ratio of FF/VI 100/25mcg Vs Placebo for Day 1, PM||
1604275|NCT02712008|2946375|Superiority||difference in percentages|8.8||||0.3528|2-Sided|95.0|-9.9|27.4||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.|
1604276|NCT02712008|2946375|Superiority||difference in percentages|0.2||||0.9801|2-Sided|95.0|-19.0|19.5||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.|
1604277|NCT02712008|2946375|Superiority||difference in percentages|8.8||||0.3546|2-Sided|95.0|-9.8|27.4||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.|
1604278|NCT02712008|2946375|Superiority||difference in percentages|-1.5||||0.8683|2-Sided|95.0|-19.7|16.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.|
1604279|NCT02712008|2946375|Superiority||difference in percentages|6.0||||0.5273|2-Sided|95.0|-12.8|24.7||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.|
1604280|NCT02712008|2946375|Superiority||difference in percentages|6.4||||0.5021|2-Sided|95.0|-12.6|25.5||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.|
1604281|NCT02712008|2946375|Superiority||difference in percentages|-1.3||||0.8896|2-Sided|95.0|-20.4|17.7||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Difference with Confidence Interval was calculated using Mantel-Haenszel weighting scheme adjusted by BCVA stratification variable.|
1604282|NCT02712008|2946376|Superiority||difference in percentages|6.1||||0.2268|2-Sided|95.0|0.0|16.3||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using analysis of Cochran-Mantel-Haenszel model.|
1604283|NCT02712008|2946376|Superiority||difference in percentages|-1.8||||0.7617|2-Sided|95.0|-13.5|9.8||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using analysis of Cochran-Mantel-Haenszel model.|
1604284|NCT02712008|2946377|Superiority||Least square mean difference|-38.9||||0.0351|2-Sided|95.0|-75.06|-2.73||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604285|NCT02712008|2946377|Superiority||Least square mean difference|3.36||||0.8574|2-Sided|95.0|-33.42|40.14||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604286|NCT02712008|2946377|Superiority||Least square mean difference|-15.49||||0.4116|2-Sided|95.0|-52.58|21.59||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604287|NCT02712008|2946377|Superiority||Least square mean difference|1.75||||0.9266|2-Sided|95.0|-35.54|39.03||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604288|NCT02712008|2946377|Superiority||Least square mean difference|-37.15||||0.0454|2-Sided|95.0|-73.53|-0.77||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604289|NCT02712008|2946377|Superiority||Least square mean difference|-40.51||||0.0365|2-Sided|95.0|-78.46|-2.57||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604290|NCT02712008|2946377|Superiority||Least square mean difference|-55.91||||0.004|2-Sided|95.0|0.0|0.0||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604291|NCT02712008|2946378|Superiority||Least square mean difference|-27.79||||0.0183|2-Sided|95.0|0.0|0.0||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|
1604292|NCT02712008|2946378|Superiority||Least square mean difference|-24.43||||0.1105|2-Sided|95.0|-54.46|5.61||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|
1604293|NCT02712008|2946379|Superiority||Least square mean difference|-0.27||||0.8537|2-Sided|95.0|-3.18|2.63||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604294|NCT02712008|2946379|Superiority||Least square mean difference|-1.51||||0.3159|2-Sided|-1.51|-4.47|1.45||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604295|NCT02712008|2946379|Superiority||Least square mean difference|2.33||||0.1278|2-Sided|95.0|-0.67|5.33||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604296|NCT02712008|2946379|Superiority||Least square mean difference|0.66||||0.6655|2-Sided|95.0|-2.35|3.67||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604297|NCT02712008|2946379|Superiority||Least square mean difference|0.39||||0.7943|2-Sided|95.0|-2.54|3.32||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604830|NCT02701634|2947016|Superiority|||||||0.49||||||P-value was calculated using the two sample proportion t-test.|t-test, 2 sided||||
1604298|NCT02712008|2946379|Superiority||Least square mean difference|1.9||||0.2223|2-Sided|95.0|-1.16|4.95||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604299|NCT02712008|2946379|Superiority||Least square mean difference|2.15||||0.1665|2-Sided|95.0|-0.9|5.2||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using ANCOVA model with baseline measurement as a covariate, and treatment group and BCVA stratification variable as fixed factors.|
1604300|NCT02712008|2946380|Superiority||Least square mean difference|0.04||||0.9716|2-Sided|95.0|0.0|2.18||Threshold for significance at 0.05 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|
1604301|NCT02712008|2946380|Superiority|Analysis was performed using analysis of covariance (ANCOVA) model with baseline measurement as a covariate and treatment group as fixed factors.|Least square mean difference|-2.09||||0.1368|2-Sided|95.0|0.0|0.67||Threshold for significance at 0.05 level.|ANCOVA||||
1604302|NCT02710630|2946429|Superiority or Other||Ratio [Test/Reference]|106.64|Standard Deviation|38.9|||2-Sided|90.0|91.625|124.114|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604303|NCT02710630|2946429|Superiority or Other||Ratio [Test/Reference]|107.13|Standard Deviation|49.6|||2-Sided|90.0|88.616|129.51|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604304|NCT02710630|2946429|Superiority or Other||Ratio [Test/Reference]|68.77|Standard Deviation|50.3|||2-Sided|90.0|56.452|83.782|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604305|NCT02710630|2946429|Superiority or Other||Ratio [Test/Reference]|83.73|Standard Deviation|62.8|||2-Sided|90.0|66.033|106.163|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604306|NCT02710630|2946429|Superiority or Other||Ratio [Test/Reference]|115.27|Standard Deviation|38.4|||2-Sided|90.0|99.063|134.13|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604307|NCT02710630|2946430|Superiority or Other||Ratio [Test/Reference]|103.73|Standard Deviation|43.3|||2-Sided|90.0|87.74|122.628|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604308|NCT02710630|2946430|Superiority or Other||Ratio [Test/Reference]|106.38|Standard Deviation|57.0|||2-Sided|90.0|85.846|131.836|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604309|NCT02710630|2946430|Superiority or Other||Ratio [Test/Reference]|58.96|Standard Deviation|71.4|||2-Sided|90.0|45.489|76.431|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604310|NCT02710630|2946430|Superiority or Other||Ratio [Test/Reference]|54.12|Standard Deviation|138.6|||2-Sided|90.0|35.818|81.774|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604311|NCT02710630|2946430|Superiority or Other||Ratio [Test/Reference]|115.39|Standard Deviation|45.3|||2-Sided|90.0|96.74|137.644|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604312|NCT02710630|2946431|Superiority or Other||Ratio [Test/Reference]|107.07|Standard Deviation|40.7|||2-Sided|90.0|91.399|125.432|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604313|NCT02710630|2946431|Superiority or Other||Ratio [Test/Reference]|106.99|Standard Deviation|52.8|||2-Sided|90.0|87.554|130.732|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604314|NCT02710630|2946431|Superiority or Other||Ratio [Test/Reference]|56.71|Standard Deviation|74.2|||2-Sided|90.0|43.388|74.122|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604315|NCT02710630|2946431|Superiority or Other||Ratio [Test/Reference]|50.43|Standard Deviation|173.7|||2-Sided|90.0|31.519|80.689|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604316|NCT02710630|2946431|Superiority or Other||Ratio [Test/Reference]|115.69|Standard Deviation|40.2|||2-Sided|90.0|98.783|135.491|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604317|NCT02710630|2946432|Superiority or Other||Ratio [Test/Reference]|109.85|Standard Deviation|38.7|||2-Sided|90.0|94.452|127.75|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604318|NCT02710630|2946432|Superiority or Other||Ratio [Test/Reference]|116.67|Standard Deviation|37.7|||2-Sided|90.0|100.516|135.41|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604319|NCT02710630|2946432|Superiority or Other||Ratio [Test/Reference]|71.4|Standard Deviation|49.2|||2-Sided|90.0|58.828|86.648|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604320|NCT02710630|2946432|Superiority or Other||Ratio [Test/Reference]|87.26|Standard Deviation|60.2|||2-Sided|90.0|69.404|109.722|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604321|NCT02710630|2946432|Superiority or Other||Ratio [Test/Reference]|118.26|Standard Deviation|38.5|||2-Sided|90.0|101.627|137.621|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604322|NCT02710630|2946433|Superiority or Other||Ratio [Test/Reference]|107.76|Standard Deviation|43.0|||2-Sided|90.0|91.238|127.281|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604323|NCT02710630|2946433|Superiority or Other||Ratio [Test/Reference]|108.26|Standard Deviation|55.8|||2-Sided|90.0|87.704|133.629|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604324|NCT02710630|2946433|Superiority or Other||Ratio [Test/Reference]|61.94|Standard Deviation|69.0|||2-Sided|90.0|48.13|79.72|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604325|NCT02710630|2946433|Superiority or Other||Ratio [Test/Reference]|57.49|Standard Deviation|132.3|||2-Sided|90.0|38.502|85.837|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604326|NCT02710630|2946433|Superiority or Other||Ratio [Test/Reference]|118.31|Standard Deviation|44.2|||2-Sided|90.0|99.569|140.579|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604327|NCT02710630|2946434|Superiority or Other||Ratio|110.21|Standard Deviation|41.1|||2-Sided|90.0|93.939|129.297|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: E1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604328|NCT02710630|2946434|Superiority or Other||Ratio [Test/Reference]|108.21|Standard Deviation|55.7|||2-Sided|90.0|87.698|133.53|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: D1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604329|NCT02710630|2946434|Superiority or Other||Ratio [Test/Reference]|59.01|Standard Deviation|73.4|||2-Sided|90.0|45.255|76.955|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: C1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604330|NCT02710630|2946434|Superiority or Other||Ratio [Test/Reference]|52.97|Standard Deviation|168.9|||2-Sided|90.0|33.341|84.158|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: B1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604331|NCT02710630|2946434|Superiority or Other||Ratio [Test/Reference]|119.33|Standard Deviation|40.4|||2-Sided|90.0|101.838|139.834|||||"The adjusted geometric mean (gMean) ratio [%] calculated as Dabigatran Etexilate Tablet: A1/Dabigatran Etexilate Capsule: Ref.~Standard deviation is actually intra-individual geometric coefficient of variation (gCV) [%]."||
1604332|NCT02709486|2946504|Superiority||LS Mean Ratio|0.8|Standard Error of the Mean|0.26||0.5076|2-Sided|95.0|0.42|1.53|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604333|NCT02709486|2946504|Superiority||LS Mean Ratio|0.82|Standard Error of the Mean|0.27||0.556|2-Sided|95.0|0.43|1.58|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604334|NCT02709486|2946504|Superiority||LS Mean Ratio|0.72|Standard Error of the Mean|0.22||0.2863|2-Sided|95.0|0.4|1.31|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group|
1604335|NCT02709486|2946504|Superiority||LS Mean Ratio|0.71|Standard Error of the Mean|0.22||0.2627|2-Sided|95.0|0.39|1.29|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604336|NCT02709486|2946504|Superiority||LS Mean Ratio|0.69|Standard Error of the Mean|0.22||0.2387|2-Sided|95.0|0.37|1.28|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604337|NCT02709486|2946504|Superiority||LS Mean Ratio|0.67|Standard Error of the Mean|0.21||0.2096|2-Sided|95.0|0.36|1.25|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604831|NCT02701634|2947017|Superiority|||||||0.33||||||P-value was calculated using the two sample proportion t-test.|t-test, 2 sided||||
1604832|NCT02701634|2947018|Superiority|||||||0.67|||||||Log Rank||||
1604338|NCT02709486|2946504|Superiority||LS Mean Ratio|0.77|Standard Error of the Mean|0.22||0.3569|2-Sided|95.0|0.44|1.34|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604339|NCT02709486|2946504|Superiority||LS Mean Ratio|0.65|Standard Error of the Mean|0.18||0.1215|2-Sided|95.0|0.37|1.12|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604340|NCT02709486|2946504|Superiority||LS Mean Ratio|0.75|Standard Error of the Mean|0.2||0.296|2-Sided|95.0|0.44|1.28|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604341|NCT02709486|2946504|Superiority||LS Mean Ratio|0.6|Standard Error of the Mean|0.16||0.0567|2-Sided|95.0|0.35|1.01|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604342|NCT02709486|2946504|Superiority||LS Mean Ratio|0.73|Standard Error of the Mean|0.17||0.1895|2-Sided|95.0|0.46|1.17|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604343|NCT02709486|2946504|Superiority||LS Mean Ratio|0.62|Standard Error of the Mean|0.15||0.0441|2-Sided|95.0|0.39|0.99|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604344|NCT02709486|2946506|Superiority||LS Mean Ratio|0.82|Standard Error of the Mean|0.13||0.2056|2-Sided|95.0|0.61|1.11|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604345|NCT02709486|2946506|Superiority||LS Mean Ratio|0.85|Standard Error of the Mean|0.13||0.3057|2-Sided|95.0|0.63|1.16|||Negative binomial model|||Week 24: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604346|NCT02709486|2946506|Superiority||LS Mean Ratio|0.81|Standard Error of the Mean|0.11||0.1305|2-Sided|95.0|0.61|1.06|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604347|NCT02709486|2946506|Superiority||LS Mean Ratio|0.78|Standard Error of the Mean|0.11||0.0751|2-Sided|95.0|0.59|1.03|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604348|NCT02709486|2946506|Superiority||LS Mean Ratio|0.75|Standard Error of the Mean|0.11||0.0468|2-Sided|95.0|0.57|1.0|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604349|NCT02709486|2946506|Superiority||LS Mean Ratio|0.74|Standard Error of the Mean|0.11||0.0374|2-Sided|95.0|0.56|0.98|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604350|NCT02709486|2946506|Superiority||LS Mean Ratio|0.75|Standard Error of the Mean|0.09||0.0237|2-Sided|95.0|0.59|0.96|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604351|NCT02709486|2946506|Superiority||LS Mean Ratio|0.72|Standard Error of the Mean|0.09||0.0093|2-Sided|95.0|0.56|0.92|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604352|NCT02709486|2946506|Superiority||LS Mean Ratio|0.74|Standard Error of the Mean|0.09||0.0112|2-Sided|95.0|0.58|0.93|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604353|NCT02709486|2946506|Superiority||LS Mean Ratio|0.64|Standard Error of the Mean|0.08||0.0003|2-Sided|95.0|0.51|0.82|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604354|NCT02709486|2946506|Superiority||LS Mean Ratio|0.75|Standard Error of the Mean|0.08||0.0067|2-Sided|95.0|0.61|0.92|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604355|NCT02709486|2946506|Superiority||LS Mean Ratio|0.67|Standard Error of the Mean|0.07||0.0001|2-Sided|95.0|0.54|0.82|||Negative binomial model|||Week 2: Least square (LS) Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604833|NCT02701634|2947023|Superiority|||||||0.99||||||P-value was calculated using the stratified Cochran-Mantel-Haenszel Chi-square test.|Chi-squared||||
1604356|NCT02709486|2946508|Superiority||Odds Ratio (OR)|0.84||||0.3238|2-Sided|95.0|0.6|1.18|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604357|NCT02709486|2946508|Superiority||Odds Ratio (OR)|1.01||||0.9449|2-Sided|95.0|0.72|1.42|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604358|NCT02709486|2946508|Superiority||Odds Ratio (OR)|0.62||||0.006|2-Sided|95.0|0.45|0.87|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604359|NCT02709486|2946508|Superiority||Odds Ratio (OR)|0.7||||0.0399|2-Sided|95.0|0.5|0.98|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604360|NCT02709486|2946508|Superiority||Odds Ratio (OR)|0.65||||0.0124|2-Sided|95.0|0.47|0.91|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604361|NCT02709486|2946508|Superiority||Odds Ratio (OR)|0.65||||0.0129|2-Sided|95.0|0.47|0.91|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604362|NCT02709486|2946508|Superiority||Odds Ratio (OR)|0.74||||0.0787|2-Sided|95.0|0.53|1.04|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604363|NCT02709486|2946508|Superiority||Odds Ratio (OR)|0.64||||0.0087|2-Sided|95.0|0.45|0.89|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604364|NCT02709486|2946508|Superiority||Odds Ratio (OR)|0.62||||0.0067|2-Sided|95.0|0.44|0.88|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604365|NCT02709486|2946508|Superiority||Odds Ratio (OR)|0.5|||<|0.0001|2-Sided|95.0|0.36|0.7|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604366|NCT02709486|2946508|Superiority||Odds Ratio (OR)|0.55|||<|0.001|2-Sided|95.0|0.38|0.78|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604367|NCT02709486|2946508|Superiority||Odds Ratio (OR)|0.42|||<|0.0001|2-Sided|95.0|0.29|0.59|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604368|NCT02709486|2946509|Superiority|||||||0.0007||||||P-value based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.|
1604369|NCT02709486|2946509|Superiority|||||||0.0002||||||P-value based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.|
1604370|NCT02709486|2946510|Superiority||Odds Ratio (OR)|0.16||||0.0033|2-Sided|95.0|0.05|0.54|||Regression, Logistic|||Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.|
1604371|NCT02709486|2946510|Superiority||Odds Ratio (OR)|0.1||||0.0027|2-Sided|95.0|0.02|0.46|||Regression, Logistic|||Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade and treatment. Odds ratio and 95% CI estimated from logistic regression model.|
1604372|NCT02709486|2946525|Superiority||Least Square Mean Difference|-4.94|Standard Error of the Mean|1.86||0.0079|2-Sided|95.0|-8.59|-1.3|||ANCOVA|||Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect|
1604373|NCT02709486|2946525|Superiority||Least Square Mean Difference|-3.08|Standard Error of the Mean|1.87||0.1004|2-Sided|95.0|-6.76|0.6|||ANCOVA|||Week 24: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604374|NCT02709486|2946525|Superiority||Least Square Mean Difference|-6.97|Standard Error of the Mean|1.77|<|0.0001|2-Sided|95.0|-10.44|-3.51|||ANCOVA|||Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604935|NCT02698189|2947280|Other|80% Bayesian credible interval based on a prior distribution of Beta (1, 1).|||||||||||||||||80% 2-sided Bayesian credible interval: lower = 0.040; upper = 0.391
1606387|NCT02651688|2950565|Superiority|||||||0.5873|||||||Wilcoxon rank-sum test||||
1604375|NCT02709486|2946525|Superiority||Least Square Mean Difference|-6.0|Standard Error of the Mean|1.79|<|0.0008|2-Sided|95.0|-9.51|-2.5|||ANCOVA|||Week 16: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604376|NCT02709486|2946525|Superiority||Least Square Mean Difference|-9.13|Standard Error of the Mean|1.6|<|0.0001|2-Sided|95.0|-12.26|-6.0|||ANCOVA|||Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604377|NCT02709486|2946525|Superiority||Least Square Mean Difference|-6.18|Standard Error of the Mean|1.61|<|0.0001|2-Sided|95.0|-9.34|-3.03|||ANCOVA|||Week 8: Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604378|NCT02709486|2946525|Superiority||Least Square Mean Difference|-2.11|Standard Error of the Mean|4.62|<|0.6485|2-Sided|95.0|-11.31|7.08|||ANCOVA|||Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604379|NCT02709486|2946525|Superiority||Least Square Mean Difference|-3.85|Standard Error of the Mean|4.43|<|0.3869|2-Sided|95.0|-12.66|4.96|||ANCOVA|||Week 24: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604380|NCT02709486|2946525|Superiority||Least Square Mean Difference|-10.04|Standard Error of the Mean|3.97|<|0.0129|2-Sided|95.0|-17.91|-2.17|||ANCOVA|||Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604381|NCT02709486|2946525|Superiority||Least Square Mean Difference|-9.41|Standard Error of the Mean|3.74|<|0.0135|2-Sided|95.0|-16.83|-1.99|||ANCOVA|||Week 16: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604382|NCT02709486|2946525|Superiority||Least Square Mean Difference|-12.48|Standard Error of the Mean|3.87|<|0.0017|2-Sided|95.0|-20.15|-4.81|||ANCOVA|||Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604383|NCT02709486|2946525|Superiority||Least Square Mean Difference|-6.75|Standard Error of the Mean|3.79|<|0.0774|2-Sided|95.0|-14.26|0.76|||ANCOVA|||Week 8: Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604384|NCT02709486|2946525|Superiority||Least Square Mean Difference|-2.74|Standard Error of the Mean|4.54|<|0.5483|2-Sided|95.0|-11.78|6.3|||ANCOVA|||Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604385|NCT02709486|2946525|Superiority||Least Square Mean Difference|-4.28|Standard Error of the Mean|4.37|<|0.3302|2-Sided|95.0|-12.97|4.41|||ANCOVA|||Week 24: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604386|NCT02709486|2946525|Superiority||Least Square Mean Difference|-10.56|Standard Error of the Mean|4.0|<|0.0096|2-Sided|95.0|-18.49|-2.63|||ANCOVA|||Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604387|NCT02709486|2946525|Superiority||Least Square Mean Difference|-10.31|Standard Error of the Mean|3.8|<|0.0079|2-Sided|95.0|-17.85|-2.77|||ANCOVA|||Week 16: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604388|NCT02709486|2946525|Superiority||Least Square Mean Difference|-12.69|Standard Error of the Mean|3.74|<|0.001|2-Sided|95.0|-20.11|-5.26|||ANCOVA|||Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604389|NCT02709486|2946525|Superiority||Least Square Mean Difference|-6.68|Standard Error of the Mean|3.67|<|0.0717|2-Sided|95.0|-13.97|0.6|||ANCOVA|||Week 8: Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604390|NCT02709486|2946525|Superiority||Least Square Mean Difference|-2.93|Standard Error of the Mean|2.54|<|0.2514|2-Sided|95.0|-7.97|2.11|||ANCOVA|||Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604756|NCT02706847|2946766|Superiority||Response Rate Difference|22.3|||<|0.001|2-Sided|95.0|13.6|31.1||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo||
1604391|NCT02709486|2946525|Superiority||Least Square Mean Difference|-1.32|Standard Error of the Mean|2.41|<|0.5845|2-Sided|95.0|-6.12|3.47|||ANCOVA|||Week 24: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604392|NCT02709486|2946525|Superiority||Least Square Mean Difference|-4.52|Standard Error of the Mean|2.85|<|0.1157|2-Sided|95.0|-10.16|1.13|||ANCOVA|||Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604393|NCT02709486|2946525|Superiority||Least Square Mean Difference|-0.62|Standard Error of the Mean|2.73|<|0.8204|2-Sided|95.0|-6.03|4.79|||ANCOVA|||Week 16: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604394|NCT02709486|2946525|Superiority||Least Square Mean Difference|-2.09|Standard Error of the Mean|2.59|<|0.4208|2-Sided|95.0|-7.22|3.04|||ANCOVA|||Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604395|NCT02709486|2946525|Superiority||Least Square Mean Difference|1.2|Standard Error of the Mean|2.57|<|0.6427|2-Sided|95.0|-3.9|6.29|||ANCOVA|||Week 8: Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604396|NCT02709486|2946528|Superiority||Least Square Mean Difference|-0.71|Standard Error of the Mean|0.2||0.0003|2-Sided|95.0|-1.1|-0.33|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604397|NCT02709486|2946528|Superiority||Least Square Mean Difference|-0.44|Standard Error of the Mean|0.2||0.0246|2-Sided|95.0|-0.82|-0.06|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604398|NCT02709486|2946528|Superiority||Least Square Mean Difference|-0.77|Standard Error of the Mean|0.19|<|0.0001|2-Sided|95.0|-1.13|-0.4|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604399|NCT02709486|2946528|Superiority||Least Square Mean Difference|-0.66|Standard Error of the Mean|0.19|<|0.0005|2-Sided|95.0|-1.03|-0.29|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604400|NCT02709486|2946528|Superiority||Least Square Mean Difference|-0.87|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.23|-0.51|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604401|NCT02709486|2946528|Superiority||Least Square Mean Difference|-0.75|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.11|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604402|NCT02709486|2946528|Superiority||Least Square Mean Difference|-1.01|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.35|-0.67|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604403|NCT02709486|2946528|Superiority||Least Square Mean Difference|-0.76|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.11|-0.42|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604404|NCT02709486|2946528|Superiority||Least Square Mean Difference|-0.96|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.28|-0.65|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604771|NCT02706717|2946800|Superiority||Mean Difference (Net)|-32.7||||0.29|2-Sided|95.0|-93.5|28.2|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.||
1606388|NCT02651688|2950566|Superiority|||||||0.0227|||||||Wilcoxon rank-sum test||||
1604405|NCT02709486|2946528|Superiority||Least Square Mean Difference|-0.97|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.29|-0.65|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604406|NCT02709486|2946528|Superiority||Least Square Mean Difference|-0.57|Standard Error of the Mean|0.15|<|0.0002|2-Sided|95.0|-0.87|-0.27|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604407|NCT02709486|2946528|Superiority||Least Square Mean Difference|-0.69|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-0.99|-0.39|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604408|NCT02709486|2946530|Superiority||Least Square Mean Difference|-0.59|Standard Error of the Mean|0.19||0.0019|2-Sided|95.0|-0.96|-0.22|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604409|NCT02709486|2946530|Superiority||Least Square Mean Difference|-0.4|Standard Error of the Mean|0.19||0.0377|2-Sided|95.0|-0.78|-0.02|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604410|NCT02709486|2946530|Superiority||Least Square Mean Difference|-0.6|Standard Error of the Mean|0.18||0.0009|2-Sided|95.0|-0.96|-0.25|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604411|NCT02709486|2946530|Superiority||Least Square Mean Difference|-0.62|Standard Error of the Mean|0.18||0.0006|2-Sided|95.0|-0.98|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604412|NCT02709486|2946530|Superiority||Least Square Mean Difference|-0.79|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.14|-0.44|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604413|NCT02709486|2946530|Superiority||Least Square Mean Difference|-0.74|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.08|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604414|NCT02709486|2946530|Superiority||Least Square Mean Difference|-0.72|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.04|-0.4|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604415|NCT02709486|2946530|Superiority||Least Square Mean Difference|-0.59|Standard Error of the Mean|0.16|<|0.0003|2-Sided|95.0|-0.91|-0.27|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604416|NCT02709486|2946530|Superiority||Least Square Mean Difference|-0.86|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.16|-0.55|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604417|NCT02709486|2946530|Superiority||Least Square Mean Difference|-0.82|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.13|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604772|NCT02706717|2946803|Superiority||Mean Difference (Net)|28.4||||0.09|2-Sided|95.0|-3.6|71.0|||t-test, 2 sided|2-sample t-test with equal variance|"The estimation parameter is the percent difference between the geometric mean fold changes.~With d-dimer data log10 transformed, this is (exp(Visbiome ES mean minus placebo mean) - 1)*100."||
1604418|NCT02709486|2946530|Superiority||Least Square Mean Difference|-0.37|Standard Error of the Mean|0.15|<|0.0139|2-Sided|95.0|-0.67|-0.08|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604419|NCT02709486|2946530|Superiority||Least Square Mean Difference|-0.67|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-0.96|-0.38|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604420|NCT02709486|2946532|Superiority||Least Square Mean Difference|-0.73|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.07|-0.39|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.|
1604421|NCT02709486|2946532|Superiority||Least Square Mean Difference|-0.55|Standard Error of the Mean|0.17|<|0.0015|2-Sided|95.0|-0.89|-0.21|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.|
1604422|NCT02709486|2946532|Superiority||Least Square Mean Difference|-0.67|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-0.99|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.|
1604423|NCT02709486|2946532|Superiority||Least Square Mean Difference|-0.63|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-0.95|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.|
1604424|NCT02709486|2946532|Superiority||Least Square Mean Difference|-0.81|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.12|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.|
1604425|NCT02709486|2946532|Superiority||Least Square Mean Difference|-0.78|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.09|-0.47|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.|
1604426|NCT02709486|2946532|Superiority||Least Square Mean Difference|-0.84|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-1.13|-0.56|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.|
1604427|NCT02709486|2946532|Superiority||Least Square Mean Difference|-0.61|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-0.9|-0.32|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.|
1604428|NCT02709486|2946532|Superiority||Least Square Mean Difference|-0.8|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-1.08|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.|
1604429|NCT02709486|2946532|Superiority||Least Square Mean Difference|-0.77|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-1.04|-0.49|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.|
1604430|NCT02709486|2946532|Superiority||Least Square Mean Difference|-0.47|Standard Error of the Mean|0.13|<|0.0004|2-Sided|95.0|-0.73|-0.21|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.|
1604431|NCT02709486|2946532|Superiority||Least Square Mean Difference|-0.71|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-0.96|-0.45|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average scores and baseline diary average pain as covariates, and study site as a random effect.|
1604432|NCT02709486|2946534|Superiority||Least Square Mean Difference|-0.87|Standard Error of the Mean|0.19|<|0.0001|2-Sided|95.0|-1.25|-0.5|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604433|NCT02709486|2946534|Superiority||Least Square Mean Difference|-0.62|Standard Error of the Mean|0.19|<|0.0013|2-Sided|95.0|-0.99|-0.24|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604434|NCT02709486|2946534|Superiority||Least Square Mean Difference|-0.77|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.12|-0.43|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604435|NCT02709486|2946534|Superiority||Least Square Mean Difference|-0.65|Standard Error of the Mean|0.18|<|0.0002|2-Sided|95.0|-1.0|-0.3|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604436|NCT02709486|2946534|Superiority||Least Square Mean Difference|-0.84|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.18|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604437|NCT02709486|2946534|Superiority||Least Square Mean Difference|-0.8|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.14|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604438|NCT02709486|2946534|Superiority||Least Square Mean Difference|-0.99|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.31|-0.67|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604439|NCT02709486|2946534|Superiority||Least Square Mean Difference|-0.58|Standard Error of the Mean|0.17|<|0.0004|2-Sided|95.0|-0.91|-0.26|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604440|NCT02709486|2946534|Superiority||Least Square Mean Difference|-0.84|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.15|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604441|NCT02709486|2946534|Superiority||Least Square Mean Difference|-0.72|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.03|-0.41|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604442|NCT02709486|2946534|Superiority||Least Square Mean Difference|-0.64|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-0.94|-0.35|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604443|NCT02709486|2946534|Superiority||Least Square Mean Difference|-0.77|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-1.07|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604444|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.52|Standard Error of the Mean|0.2||0.0086|2-Sided|95.0|-0.91|-0.13|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604445|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.39|Standard Error of the Mean|0.2||0.0506|2-Sided|95.0|-0.78|0.0|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1606389|NCT02651688|2950566|Superiority|||||||0.1524|||||||Wilcoxon rank-sum test||||
1604446|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.68|Standard Error of the Mean|0.19||0.0002|2-Sided|95.0|-1.05|-0.32|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604447|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.7|Standard Error of the Mean|0.19||0.0002|2-Sided|95.0|-1.06|-0.33|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604448|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.63|Standard Error of the Mean|0.18||0.0005|2-Sided|95.0|-0.98|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604449|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.52|Standard Error of the Mean|0.18||0.004|2-Sided|95.0|-0.87|-0.16|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604450|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.8|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.13|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604451|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.73|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.06|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604452|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.77|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.1|-0.44|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604453|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.72|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.05|-0.39|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604454|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.81|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.13|-0.5|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604455|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.61|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-0.93|-0.3|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604456|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.95|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.25|-0.64|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604457|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.9|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.2|-0.59|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604458|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.77|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-1.06|-0.47|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604459|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.91|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-1.2|-0.62|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604476|NCT02709486|2946537|Superiority||Odds Ratio (OR)|1.62|||<|0.1274|2-Sided|95.0|0.87|3.02|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604460|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.49|Standard Error of the Mean|0.14|<|0.0006|2-Sided|95.0|-0.77|-0.21|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604461|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.78|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-1.06|-0.5|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604462|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.51|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-0.77|-0.25|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604463|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.74|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-1.0|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604464|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.36|Standard Error of the Mean|0.11|<|0.0009|2-Sided|95.0|-0.58|-0.15|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604465|NCT02709486|2946536|Superiority||Least Square Mean Difference|-0.49|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-0.7|-0.27|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1604466|NCT02709486|2946537|Superiority||Odds Ratio (OR)|1.97||||0.0064|2-Sided|95.0|1.21|3.21|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604467|NCT02709486|2946537|Superiority||Odds Ratio (OR)|1.56||||0.0775|2-Sided|95.0|0.95|2.55|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604468|NCT02709486|2946537|Superiority||Odds Ratio (OR)|2.94|||<|0.0001|2-Sided|95.0|1.77|4.86|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604469|NCT02709486|2946537|Superiority||Odds Ratio (OR)|1.83|||<|0.0203|2-Sided|95.0|1.1|3.06|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604470|NCT02709486|2946537|Superiority||Odds Ratio (OR)|3.16|||<|0.0001|2-Sided|95.0|1.92|5.21|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604471|NCT02709486|2946537|Superiority||Odds Ratio (OR)|2.4|||<|0.0006|2-Sided|95.0|1.45|3.98|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604472|NCT02709486|2946537|Superiority||Odds Ratio (OR)|2.41|||<|0.0012|2-Sided|95.0|1.42|4.1|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604473|NCT02709486|2946537|Superiority||Odds Ratio (OR)|2.04|||<|0.0089|2-Sided|95.0|1.2|3.49|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604474|NCT02709486|2946537|Superiority||Odds Ratio (OR)|3.34|||<|0.0001|2-Sided|95.0|1.84|6.03|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604475|NCT02709486|2946537|Superiority||Odds Ratio (OR)|2.62|||<|0.0016|2-Sided|95.0|1.44|4.76|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604773|NCT02706717|2946804|Superiority||Mean Difference (Net)|0.042||||0.51|2-Sided|95.0|-0.09|0.17|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.||
1604477|NCT02709486|2946537|Superiority||Odds Ratio (OR)|2.14|||<|0.0132|2-Sided|95.0|1.17|3.9|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline patient global assessment of osteoarthritis scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604478|NCT02709486|2946539|Superiority||Odds Ratio (OR)|3.14||||0.0296|2-Sided|95.0|1.12|8.81|||Regression, Logistic|||Week 24, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604479|NCT02709486|2946539|Superiority||Odds Ratio (OR)|3.3||||0.0236|2-Sided|95.0|1.17|9.27|||Regression, Logistic|||Week 24, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604480|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.25||||0.3435|2-Sided|95.0|0.79|1.98|||Regression, Logistic|||Week 24, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604481|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.47||||0.097|2-Sided|95.0|0.93|2.31|||Regression, Logistic|||Week 24, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604482|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.73||||0.0018|2-Sided|95.0|1.23|2.45|||Regression, Logistic|||Week 24, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604483|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.54||||0.0152|2-Sided|95.0|1.09|2.18|||Regression, Logistic|||Week 24, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604484|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.13|||<|0.0001|2-Sided|95.0|1.51|3.02|||Regression, Logistic|||Week 24, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604485|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.83|||<|0.0006|2-Sided|95.0|1.29|2.57|||Regression, Logistic|||Week 24, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604486|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.64|||<|0.0373|2-Sided|95.0|1.06|6.57|||Regression, Logistic|||Week 16, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604487|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.94|||<|0.0212|2-Sided|95.0|1.18|7.37|||Regression, Logistic|||Week 16, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604488|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.39|||<|0.1549|2-Sided|95.0|0.88|2.2|||Regression, Logistic|||Week 16, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604489|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.74|||<|0.0155|2-Sided|95.0|1.11|2.72|||Regression, Logistic|||Week 16, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604490|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.72|||<|0.0022|2-Sided|95.0|1.22|2.43|||Regression, Logistic|||Week 16, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604491|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.68|||<|0.0035|2-Sided|95.0|1.19|2.38|||Regression, Logistic|||Week 16, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604492|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.77|||<|0.0011|2-Sided|95.0|1.26|2.5|||Regression, Logistic|||Week 16, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604493|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.72|||<|0.0018|2-Sided|95.0|1.22|2.43|||Regression, Logistic|||Week 16, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604494|NCT02709486|2946539|Superiority||Odds Ratio (OR)|8.62|||<|0.0044|2-Sided|95.0|1.96|37.96|||Regression, Logistic|||Week 12, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1606390|NCT02651688|2950567|Superiority|||||||0.0018|||||||Wilcoxon rank-sum test||||
1604495|NCT02709486|2946539|Superiority||Odds Ratio (OR)|10.84|||<|0.0015|2-Sided|95.0|2.49|47.22|||Regression, Logistic|||Week 12, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604496|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.86|||<|0.0072|2-Sided|95.0|1.18|2.94|||Regression, Logistic|||Week 12, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604497|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.74|||<|0.018|2-Sided|95.0|1.1|2.76|||Regression, Logistic|||Week 12, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604498|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.08|||<|0.0001|2-Sided|95.0|1.46|2.96|||Regression, Logistic|||Week 12, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604499|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.1|||<|0.0001|2-Sided|95.0|1.47|3.0|||Regression, Logistic|||Week 12, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604500|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.19|||<|0.0001|2-Sided|95.0|1.55|3.1|||Regression, Logistic|||Week 12, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604501|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.01|||<|0.0001|2-Sided|95.0|1.43|2.84|||Regression, Logistic|||Week 12, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604502|NCT02709486|2946539|Superiority||Odds Ratio (OR)|3.79|||<|0.0211|2-Sided|95.0|1.22|11.78|||Regression, Logistic|||Week 8, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604503|NCT02709486|2946539|Superiority||Odds Ratio (OR)|4.1|||<|0.015|2-Sided|95.0|1.31|12.79|||Regression, Logistic|||Week 8, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604504|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.43|||<|0.0018|2-Sided|95.0|1.39|4.24|||Regression, Logistic|||Week 8, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604505|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.61|||<|0.0007|2-Sided|95.0|1.49|4.55|||Regression, Logistic|||Week 8, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604506|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.13|||<|0.0001|2-Sided|95.0|1.46|3.1|||Regression, Logistic|||Week 8, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604507|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.86|||<|0.0014|2-Sided|95.0|1.27|2.71|||Regression, Logistic|||Week 8, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604508|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.75|||<|0.001|2-Sided|95.0|1.26|2.45|||Regression, Logistic|||Week 8, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604509|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.65|||<|0.0034|2-Sided|95.0|1.18|2.31|||Regression, Logistic|||Week 8, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604510|NCT02709486|2946539|Superiority||Odds Ratio (OR)|4.49|||<|0.021|2-Sided|95.0|1.25|16.05|||Regression, Logistic|||Week 4, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604511|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.67|||<|0.1516|2-Sided|95.0|0.7|10.26|||Regression, Logistic|||Week 4, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604512|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.18|||<|0.0126|2-Sided|95.0|1.18|4.02|||Regression, Logistic|||Week 4, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1606391|NCT02651688|2950567|Superiority|||||||0.0146|||||||Wilcoxon rank-sum test||||
1604513|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.23|||<|0.0107|2-Sided|95.0|1.21|4.14|||Regression, Logistic|||Week 4, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604514|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.28|||<|0.0001|2-Sided|95.0|1.53|3.4|||Regression, Logistic|||Week 4, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604515|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.91|||<|0.002|2-Sided|95.0|1.27|2.87|||Regression, Logistic|||Week 4, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604516|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.1|||<|0.0001|2-Sided|95.0|1.5|2.96|||Regression, Logistic|||Week 4, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604517|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.25|||<|0.0001|2-Sided|95.0|1.6|3.17|||Regression, Logistic|||Week 4, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604518|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.67|||<|0.4859|2-Sided|95.0|0.39|7.11|||Regression, Logistic|||Week 2, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604519|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.39|||<|0.2121|2-Sided|95.0|0.61|9.41|||Regression, Logistic|||Week 2, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604520|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.44|||<|0.3706|2-Sided|95.0|0.65|3.23|||Regression, Logistic|||Week 2, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604521|NCT02709486|2946539|Superiority||Odds Ratio (OR)|2.8|||<|0.0064|2-Sided|95.0|1.34|5.86|||Regression, Logistic|||Week 2, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604522|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.34|||<|0.2033|2-Sided|95.0|0.85|2.1|||Regression, Logistic|||Week 2, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604523|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.45|||<|0.1031|2-Sided|95.0|0.93|2.27|||Regression, Logistic|||Week 2, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604524|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.48|||<|0.0286|2-Sided|95.0|1.04|2.1|||Regression, Logistic|||Week 2, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604525|NCT02709486|2946539|Superiority||Odds Ratio (OR)|1.89|||<|0.0003|2-Sided|95.0|1.33|2.68|||Regression, Logistic|||Week 2, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604526|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.99||||0.1039|2-Sided|95.0|0.87|4.57|||Regression, Logistic|||Week 24, >=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604527|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.8||||0.1746|2-Sided|95.0|0.77|4.22|||Regression, Logistic|||Week 24, >=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604528|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.44||||0.0867|2-Sided|95.0|0.95|2.18|||Regression, Logistic|||Week 24, >=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604529|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.32||||0.2031|2-Sided|95.0|0.86|2.01|||Regression, Logistic|||Week 24, >=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604530|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.87||||0.0004|2-Sided|95.0|1.32|2.64|||Regression, Logistic|||Week 24, >=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604936|NCT02698189|2947280|Other|80% Bayesian credible interval based on a prior distribution of Beta (1, 1).|||||||||||||||||80% 2-sided Bayesian credible interval: lower = 0.000; upper = 0.415
1604531|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.72||||0.0022|2-Sided|95.0|1.22|2.43|||Regression, Logistic|||Week 24, >=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604532|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.73||||0.0021|2-Sided|95.0|1.22|2.44|||Regression, Logistic|||Week 24, >=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604533|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.5||||0.0201|2-Sided|95.0|1.07|2.12|||Regression, Logistic|||Week 24, >=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604534|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.72||||0.223|2-Sided|95.0|0.72|4.13|||Regression, Logistic|||Week 16, >=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604535|NCT02709486|2946540|Superiority||Odds Ratio (OR)|2.98||||0.0098|2-Sided|95.0|1.3|6.83|||Regression, Logistic|||Week 16, >=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604536|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.61||||0.0253|2-Sided|95.0|1.06|2.44|||Regression, Logistic|||Week 16, >=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604537|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.47||||0.0754|2-Sided|95.0|0.96|2.24|||Regression, Logistic|||Week 16, >=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604538|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.68||||0.003|2-Sided|95.0|1.19|2.36|||Regression, Logistic|||Week 16, >=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604539|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.87||||0.0003|2-Sided|95.0|1.33|2.64|||Regression, Logistic|||Week 16, >=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604540|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.77||||0.0014|2-Sided|95.0|1.25|2.5|||Regression, Logistic|||Week 16, >=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604541|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.72||||0.0022|2-Sided|95.0|1.22|2.44|||Regression, Logistic|||Week 16, >=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604542|NCT02709486|2946540|Superiority||Odds Ratio (OR)|4.46||||0.0034|2-Sided|95.0|1.64|12.13|||Regression, Logistic|||Week 12, >=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604543|NCT02709486|2946540|Superiority||Odds Ratio (OR)|5.61||||0.0006|2-Sided|95.0|2.09|15.08|||Regression, Logistic|||Week 12, >=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604544|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.68||||0.018|2-Sided|95.0|1.09|2.58|||Regression, Logistic|||Week 12, >=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604545|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.81||||0.0064|2-Sided|95.0|1.18|2.78|||Regression, Logistic|||Week 12, >=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604546|NCT02709486|2946540|Superiority||Odds Ratio (OR)|2.07|||<|0.0001|2-Sided|95.0|1.47|2.91|||Regression, Logistic|||Week 12, >=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604547|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.79|||<|0.0009|2-Sided|95.0|1.27|2.52|||Regression, Logistic|||Week 12, >=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604548|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.8|||<|0.0011|2-Sided|95.0|1.26|2.56|||Regression, Logistic|||Week 12, >=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604549|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.85|||<|0.0007|2-Sided|95.0|1.3|2.63|||Regression, Logistic|||Week 12, >=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604550|NCT02709486|2946540|Superiority||Odds Ratio (OR)|3.0|||<|0.0271|2-Sided|95.0|1.13|7.96|||Regression, Logistic|||Week 8, >=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604551|NCT02709486|2946540|Superiority||Odds Ratio (OR)|2.26|||<|0.1155|2-Sided|95.0|0.82|6.27|||Regression, Logistic|||Week 8, >=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604552|NCT02709486|2946540|Superiority||Odds Ratio (OR)|2.55|||<|0.0001|2-Sided|95.0|1.58|4.13|||Regression, Logistic|||Week 8, >=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604553|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.65|||<|0.0537|2-Sided|95.0|0.99|2.74|||Regression, Logistic|||Week 8, >=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604554|NCT02709486|2946540|Superiority||Odds Ratio (OR)|2.41|||<|0.0001|2-Sided|95.0|1.68|3.47|||Regression, Logistic|||Week 8, >=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604555|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.84|||<|0.0012|2-Sided|95.0|1.27|2.65|||Regression, Logistic|||Week 8, >=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604556|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.63|||<|0.0048|2-Sided|95.0|1.16|2.28|||Regression, Logistic|||Week 8, >=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604557|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.83|||<|0.0006|2-Sided|95.0|1.3|2.58|||Regression, Logistic|||Week 8, >=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604558|NCT02709486|2946540|Superiority||Odds Ratio (OR)|3.77|||<|0.0214|2-Sided|95.0|1.22|11.66|||Regression, Logistic|||Week 4, >=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604559|NCT02709486|2946540|Superiority||Odds Ratio (OR)|2.95|||<|0.0683|2-Sided|95.0|0.92|9.47|||Regression, Logistic|||Week 4, >=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604560|NCT02709486|2946540|Superiority||Odds Ratio (OR)|2.17|||<|0.0046|2-Sided|95.0|1.27|3.72|||Regression, Logistic|||Week 4, >=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604561|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.8|||<|0.0373|2-Sided|95.0|1.04|3.14|||Regression, Logistic|||Week 4, >=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604562|NCT02709486|2946540|Superiority||Odds Ratio (OR)|2.17|||<|0.0001|2-Sided|95.0|1.49|3.16|||Regression, Logistic|||Week 4, >=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604563|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.81|||<|0.0024|2-Sided|95.0|1.23|2.65|||Regression, Logistic|||Week 4, >=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604564|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.81|||<|0.0006|2-Sided|95.0|1.29|2.54|||Regression, Logistic|||Week 4, >=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604565|NCT02709486|2946540|Superiority||Odds Ratio (OR)|2.04|||<|0.0001|2-Sided|95.0|1.45|2.87|||Regression, Logistic|||Week 4, >=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604566|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.33|||<|0.7174|2-Sided|95.0|0.29|6.08|||Regression, Logistic|||Week 2, >=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604567|NCT02709486|2946540|Superiority||Odds Ratio (OR)|2.4|||<|0.216|2-Sided|95.0|0.6|9.58|||Regression, Logistic|||Week 2, >=90%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604568|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.46|||<|0.3017|2-Sided|95.0|0.71|3.01|||Regression, Logistic|||Week 2, >=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604569|NCT02709486|2946540|Superiority||Odds Ratio (OR)|2.45|||<|0.0093|2-Sided|95.0|1.25|4.81|||Regression, Logistic|||Week 2, >=70%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604570|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.16|||<|0.5118|2-Sided|95.0|0.75|1.8|||Regression, Logistic|||Week 2, >=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604571|NCT02709486|2946540|Superiority||Odds Ratio (OR)|2.03|||<|0.0008|2-Sided|95.0|1.34|3.07|||Regression, Logistic|||Week 2, >=50%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604572|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.53|||<|0.016|2-Sided|95.0|1.08|2.16|||Regression, Logistic|||Week 2, >=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604573|NCT02709486|2946540|Superiority||Odds Ratio (OR)|1.83|||<|0.0006|2-Sided|95.0|1.3|2.59|||Regression, Logistic|||Week 2, >=30%: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604574|NCT02709486|2946542|Superiority||Odds Ratio (OR)|1.85||||0.0013|2-Sided|95.0|1.27|2.69|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment|
1604575|NCT02709486|2946542|Superiority||Odds Ratio (OR)|1.75||||0.0032|2-Sided|95.0|1.21|2.54|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment|
1604576|NCT02709486|2946542|Superiority||Odds Ratio (OR)|1.78||||0.0022|2-Sided|95.0|1.23|2.57|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment|
1604577|NCT02709486|2946542|Superiority||Odds Ratio (OR)|2.06||||0.0002|2-Sided|95.0|1.41|3.01|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604578|NCT02709486|2946542|Superiority||Odds Ratio (OR)|1.95||||0.0008|2-Sided|95.0|1.32|2.89|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604579|NCT02709486|2946542|Superiority||Odds Ratio (OR)|1.94||||0.0009|2-Sided|95.0|1.31|2.86|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604580|NCT02709486|2946542|Superiority||Odds Ratio (OR)|1.9||||0.0005|2-Sided|95.0|1.32|2.73|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604581|NCT02709486|2946542|Superiority||Odds Ratio (OR)|1.91||||0.0005|2-Sided|95.0|1.33|2.75|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604582|NCT02709486|2946542|Superiority||Odds Ratio (OR)|2.31|||<|0.0001|2-Sided|95.0|1.62|3.28|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604583|NCT02709486|2946542|Superiority||Odds Ratio (OR)|2.71|||<|0.0001|2-Sided|95.0|1.89|3.88|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604584|NCT02709486|2946542|Superiority||Odds Ratio (OR)|1.56|||<|0.0085|2-Sided|95.0|1.12|2.18|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604585|NCT02709486|2946542|Superiority||Odds Ratio (OR)|2.23|||<|0.0001|2-Sided|95.0|1.59|3.14|||Regression, Logistic|||Week 2: Odds ratio and 95 percent (%) confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604586|NCT02709486|2946544|Superiority||Least Square Mean Difference|-0.25|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.37|-0.13|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1604774|NCT02706717|2946810|Superiority||Mean Difference (Net)|-51.3||||0.6|2-Sided|95.0|-246.0|143.9|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.||
1604587|NCT02709486|2946544|Superiority||Least Square Mean Difference|-0.13|Standard Error of the Mean|0.06|<|0.0352|2-Sided|95.0|-0.26|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1604588|NCT02709486|2946544|Superiority||Least Square Mean Difference|-0.32|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.43|-0.2|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1604589|NCT02709486|2946544|Superiority||Least Square Mean Difference|-0.29|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.4|-0.17|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1604590|NCT02709486|2946544|Superiority||Least Square Mean Difference|-0.26|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.37|-0.15|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1604591|NCT02709486|2946544|Superiority||Least Square Mean Difference|-0.17|Standard Error of the Mean|0.06|<|0.0029|2-Sided|95.0|-0.28|-0.06|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1604592|NCT02709486|2946544|Superiority||Least Square Mean Difference|-0.32|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.43|-0.22|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1604593|NCT02709486|2946544|Superiority||Least Square Mean Difference|-0.24|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.35|-0.14|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1604594|NCT02709486|2946544|Superiority||Least Square Mean Difference|-0.17|Standard Error of the Mean|0.05|<|0.0022|2-Sided|95.0|-0.27|-0.06|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1604595|NCT02709486|2946544|Superiority||Least Square Mean Difference|-0.23|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.33|-0.12|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1604596|NCT02709486|2946546|Superiority||Least Square Mean Difference|-0.68|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.0|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604597|NCT02709486|2946546|Superiority||Least Square Mean Difference|-0.67|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.0|-0.34|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604598|NCT02709486|2946546|Superiority||Least Square Mean Difference|-0.82|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.15|-0.5|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604599|NCT02709486|2946546|Superiority||Least Square Mean Difference|-0.79|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.11|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604600|NCT02709486|2946546|Superiority||Least Square Mean Difference|-0.76|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-1.06|-0.47|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604601|NCT02709486|2946546|Superiority||Least Square Mean Difference|-0.63|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-0.93|-0.33|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604602|NCT02709486|2946546|Superiority||Least Square Mean Difference|-0.79|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-1.08|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604603|NCT02709486|2946546|Superiority||Least Square Mean Difference|-0.81|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-1.09|-0.53|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604604|NCT02709486|2946546|Superiority||Least Square Mean Difference|-0.43|Standard Error of the Mean|0.14|<|0.0014|2-Sided|95.0|-0.7|-0.17|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604605|NCT02709486|2946546|Superiority||Least Square Mean Difference|-0.69|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-0.95|-0.42|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604606|NCT02709486|2946548|Superiority||Least Square Mean Difference|-0.6|Standard Error of the Mean|0.17||0.0004|2-Sided|95.0|-0.93|-0.27|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604607|NCT02709486|2946548|Superiority||Least Square Mean Difference|-0.59|Standard Error of the Mean|0.17||0.0005|2-Sided|95.0|-0.93|-0.26|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604608|NCT02709486|2946548|Superiority||Least Square Mean Difference|-0.77|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.09|-0.44|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604609|NCT02709486|2946548|Superiority||Least Square Mean Difference|-0.72|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.05|-0.39|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604610|NCT02709486|2946548|Superiority||Least Square Mean Difference|-0.77|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-1.07|-0.47|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604611|NCT02709486|2946548|Superiority||Least Square Mean Difference|-0.62|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-0.92|-0.32|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604612|NCT02709486|2946548|Superiority||Least Square Mean Difference|-0.78|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-1.07|-0.5|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604613|NCT02709486|2946548|Superiority||Least Square Mean Difference|-0.79|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-1.08|-0.5|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604614|NCT02709486|2946548|Superiority||Least Square Mean Difference|-0.34|Standard Error of the Mean|0.14|<|0.0149|2-Sided|95.0|-0.61|-0.07|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604615|NCT02709486|2946548|Superiority||Least Square Mean Difference|-0.67|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-0.94|-0.4|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscales and baseline diary average pain as covariates, and study site as a random effect.|
1604616|NCT02709486|2946549|Superiority|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.19|Standard Error of the Mean|0.07||0.0051|2-Sided|95.0|-0.32|-0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1604617|NCT02709486|2946549|Superiority|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.11|Standard Error of the Mean|0.07||0.1092|2-Sided|95.0|-0.24|0.02||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1604618|NCT02709486|2946550|Superiority|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.71|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.05|-0.36||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604619|NCT02709486|2946550|Superiority|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.59|Standard Error of the Mean|0.18|<|0.0008|2-Sided|95.0|-0.93|-0.24||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604620|NCT02709486|2946551|Superiority|A step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. A tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.62|Standard Error of the Mean|0.18||0.0006|2-Sided|95.0|-0.97|-0.26||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604621|NCT02709486|2946551|Superiority|Step-down testing procedure within each of the primary outcome measures was applied to maintain Type I error. Tanezumab 5 mg versus placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg versus placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary outcome measures.|Least Square Mean Difference|-0.46|Standard Error of the Mean|0.18||0.0088|2-Sided|95.0|-0.81|-0.12||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1604622|NCT02709330|2946588|Other||||||<|1e-05|||||||Lin's Concordance||||
1604623|NCT02709330|2946592|Other||||||<|1e-05|||||||Lin's Concordance||||
1604624|NCT02709330|2946593|Other|||||||0.0748|||||||ANOVA||||
1604625|NCT02709330|2946594|Other|||||||0.99|||||||Kolmogorov-Smirnov Test|||Matched historical controls will be identified from the PatientsLikeMe database.|
1604626|NCT02709005|2946606|Superiority||Risk Difference (RD)|0.0|||>|0.999|2-Sided|95.0|-0.18|0.14||The test was conducted using a Fisher’s exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Clinical Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with clinical cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.|
1605189|NCT02696798|2947394|Superiority||LS Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.916||0.8|2-Sided|95.0|-1.57|2.04|||Mixed Models Analysis||||
1604627|NCT02709005|2946611|Superiority||Risk Difference (RD)|-0.09||||0.035|2-Sided|95.0|-0.24|-0.01||The test was conducted using a Fisher’s exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Therapeutic Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with therapeutic cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.|
1604628|NCT02709005|2946612|Superiority||Risk Difference (RD)|0.0|||>|0.999|2-Sided|95.0|-0.13|0.08||The test was conducted using a Fisher’s exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Therapeutic Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with therapeutic cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction.|
1604629|NCT02709005|2946613|Superiority||Risk Difference (RD)|0.0|||||2-Sided|||||||||The null hypothesis was that there was no difference in participants with related SAEs between study arms, with a two-sided alternative considering the possibility of a difference in either direction.|
1604630|NCT02709005|2946614|Superiority||Risk Difference (RD)|0.14||||0.2|2-Sided|95.0|-0.06|0.33||The test was conducted using a Fisher’s exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants Experiencing Solicited Events between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with solicited urogenital AEs between study arms, with a two-sided alternative considering the possibility of a difference in either direction.|
1604631|NCT02709005|2946615|Superiority||Risk Difference (RD)|-0.08||||0.42|2-Sided|95.0|-0.26|0.08||The test was conducted using a Fisher’s exact test at the 5% two-sided level of significance level without adjustment for multiplicity.|Fisher Exact||Difference in Proportion of Participants with Clinical Cure between 5% Monolaurin Vaginal Gel and Placebo Gel|The null hypothesis was that there was no difference in participants with clinical cure between study arms, with a two-sided alternative considering the possibility of a difference in either direction. The statistical informational goal for the study of 90 participants eligible in the modified Intent-to-Treat (mITT) efficacy population was an ad-hoc sample size determined by logistical considerations, as there was insufficient pilot data upon which to base more formal sample size calculations.|
1604632|NCT02708745|2946617|Superiority|||||||0.78||||||For the barrier 'not having enough time to discuss vaccine concerns', P=0.78. For the barrier 'not realizing until late in visit that parent had vaccine concerns', P=0.37. For the barrier 'not understanding parent specific vaccine concerns', P=0.66.|Chi-squared||||
1604633|NCT02708745|2946618|Superiority|||||||0.18|||||||Chi-squared||||
1604634|NCT02708745|2946619|Superiority|||||||0.29|||||||t-test, 2 sided||||
1604635|NCT02708433|2946632|Superiority||Mean Difference (Final Values)|0.0|Standard Deviation|48.0||0.5|2-Sided|95.0|-0.89|0.52|||Wilcoxon (Mann-Whitney)||||
1604636|NCT02708433|2946633|Superiority||Mean Difference (Final Values)|0.0|Standard Deviation|49.0||0.74|2-Sided|95.0|-0.49|0.57|||Wilcoxon (Mann-Whitney)||||
1604637|NCT02708355|2946634|Superiority or Other||Odds Ratio (OR)|1.028||||0.0442|2-Sided|95.0|1.001|1.055|||Regression, Logistic|||Association between percentage of time with intragastric pH>4 and relief of 24 ­hour heartburn was assessed using logistic regression model with relief of 24­ hour heartburn at Day 14 as dependent variable and change in percentage of time with intragastric pH>4 as the independent variable, controlling for age, sex, and body mass index (BMI).|
1604638|NCT02708290|2946636|Other|Participants in the MITA group were matched to those in Control (treatment-as-usual) group using propensity score analysis based on age and all four ATEC subscales at baseline. Least squares means were calculated for all subscales at all visits.|Mean Difference (Final Values)|4.68|||<|0.0001|2-Sided||||||Regression, Linear|||The concept of a “Visit” was developed by dividing the three-year-long observation interval into 3-month periods. All evaluations were mapped into 3-month-long bins (Reference: Mahapatra, S. et al. Autism Dev. Disord. 2018, 1). It was then hypothesized that there was a three-way interaction between an age group, Visit, and treatment. This hypothesis was modeled by applying the Linear Model with repeated measures, where a three-way interaction term was introduced to test the hypothesis.|
1604639|NCT02708277|2946637|Superiority or Other|||||||0.05|||||||Chi-squared||||
1604640|NCT02708277|2946638|Superiority or Other|||||||0.606|||||||t-test, 2 sided||||
1604641|NCT02708277|2946639|Superiority or Other|||||||0.303|||||||Chi-squared||||
1604642|NCT02708277|2946640|Superiority or Other|||||||0.009|||||||Chi-squared||||
1604643|NCT02708212|2946643|Superiority or Other|||||||0.6967|||||||t-test, 2 sided||||
1604644|NCT02708212|2946644|Superiority or Other|||||||0.0012|||||||t-test, 2 sided|||The two-sample t test will be used to compare the total doses of midazolam between the two study groups.|
1604645|NCT02708212|2946645|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||The two-sample t test will be used to compare the total doses of fentanyl and midazolam between the two study groups.|
1604646|NCT02708095|2946652|Superiority||LS Mean Difference (Final Vaules)|-0.33||||0.026|2-Sided|95.0|-0.62|-0.04|||Mixed Models Analysis||||
1604647|NCT02708095|2946652|Superiority||LS Mean Difference (Final Vaules)|-0.16||||0.285|2-Sided|95.0|-0.45|0.13|||Mixed Models Analysis||||
1604648|NCT02708095|2946653|Superiority||LS Mean Difference (Final Vaules)|-0.58||||0.243|2-Sided|95.0|-1.55|0.39|||Mixed Models Analysis||||
1604649|NCT02708095|2946653|Superiority||LS Mean Difference (Final Vaules)|-0.26||||0.6|2-Sided|95.0|-1.23|0.71|||Mixed Models Analysis||||
1604650|NCT02708095|2946654|Superiority||Odds Ratio (OR)|2.04||||0.015|2-Sided|95.0|1.15|3.62|||Regression, Logistic||||
1604651|NCT02708095|2946654|Superiority||Odds Ratio, log|1.25||||0.44|2-Sided|95.0|0.71|2.19|||Regression, Logistic||||
1604652|NCT02708095|2946655|Superiority||Odds Ratio (OR)|1.84||||0.041|2-Sided|95.0|1.02|3.29|||Regression, Logistic||||
1604653|NCT02708095|2946655|Superiority||Odds Ratio (OR)|1.28||||0.392|2-Sided|95.0|0.73|2.27|||Regression, Logistic||||
1604654|NCT02707991|2946657|Superiority||Mean Difference (Final Values)|22.0|Standard Error of the Mean|0.115||0.036|1-Sided|||||one-sided test|z-test for difference in proportions||||
1604655|NCT02707952|2946667|Non-Inferiority|The percentage of participants achieving SVR12 was calculated for each arm and a 2-sided 95% CI for the difference in SVR12 rates (Arm A minus Arm B) was calculated using the normal approximation to the binomial distribution to assess non-inferiority in SVR12 rates of arm A to arm B. If the lower bound of the confidence interval (CI) for the difference was above the non-inferiority margin of –10%, then arm A was considered non-inferior to arm B.|Rate Difference|-0.9|||||2-Sided|95.0|-2.8|0.9|||||95% CI was calculated using the normal approximation to the binomial distribution.||
1604656|NCT02707601|2946676|Other||Difference in Percentages|0.0||||1|2-Sided|95.0|-6.1|6.1|||Fisher exact test||The differences in percentages of participants between treatment groups and their 95% confidence intervals (CIs) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.||
1604657|NCT02707601|2946677|Superiority|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test||||
1604658|NCT02707601|2946677|Superiority|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test||||
1604659|NCT02707601|2946678|Superiority|||||||0.042||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test||||
1604660|NCT02707601|2946678|Superiority|||||||0.002||||||The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.|Binomial test||||
1604661|NCT02707146|2946694|Superiority||Odds Ratio (OR)|1.0|||||2-Sided|95.0|||||||||
1604662|NCT02706951|2946696|Superiority||Response Rate Difference|30.2|||<|0.001|2-Sided|95.0|23.6|36.9||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate||
1604663|NCT02706951|2946696|Superiority||Response Rate Difference|19.8|||<|0.001|2-Sided|95.0|13.8|25.8||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate||
1604664|NCT02706951|2946697|Superiority||Response Rate Difference|36.8|||<|0.001|2-Sided|95.0|28.6|45.0||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate||
1604665|NCT02706951|2946697|Superiority||Response Rate Difference|26.7|||<|0.001|2-Sided|95.0|18.5|34.8||This comparison was not part of the pre-specified multiplicity testing sequence; the nominal p-value is reported.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate||
1604666|NCT02706951|2946698|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-49.31|||<|0.001|2-Sided|95.0|-74.23|-24.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604667|NCT02706951|2946698|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-41.53|||<|0.001|2-Sided|95.0|-66.56|-16.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604668|NCT02706951|2946699|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|32.1|||<|0.001|2-Sided|95.0|24.6|39.7||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate||
1604669|NCT02706951|2946699|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|19.8|||<|0.001|2-Sided|95.0|12.8|26.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate||
1604670|NCT02706951|2946700|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|5.87|||<|0.001|2-Sided|95.0|4.42|7.32||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604671|NCT02706951|2946700|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|3.97|||<|0.001|2-Sided|95.0|2.52|5.42||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, treatment-by-visit interaction, and geographic region, and the baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1605190|NCT02696798|2947394|Superiority||LS Mean Difference (Final Values)|1.23|Standard Error of the Mean|0.893||0.17|2-Sided|95.0|-0.53|2.99|||Mixed Models Analysis||||
1604672|NCT02706951|2946701|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-0.41|||<|0.001|2-Sided|95.0|-0.51|-0.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate||
1604673|NCT02706951|2946701|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-0.33|||<|0.001|2-Sided|95.0|-0.43|-0.22||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib - Methotrexate||
1604674|NCT02706951|2946702|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|LS Mean Difference|-1.4|||<|0.001|2-Sided|95.0|-1.64|-1.17||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment as the fixed factor, and baseline value and the stratification factor geographic region as the covariates.|Difference = Upadacitinib – Methotrexate||
1604675|NCT02706951|2946702|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Least Squares (LS) Mean Difference|-1.08|||<|0.001|2-Sided|95.0|-1.32|-0.85||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment as the fixed factor, and baseline value and geographic region as the covariates.|Difference = Upadacitinib – Methotrexate||
1604676|NCT02706951|2946703|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|33.6|||<|0.001|2-Sided|95.0|25.1|42.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate||
1604677|NCT02706951|2946703|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|25.3|||<|0.001|2-Sided|95.0|16.8|33.7||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib - Methotrexate||
1604678|NCT02706951|2946704|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|30.0|||<|0.001|2-Sided|95.0|21.0|38.9||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib – Methotrexate||
1604679|NCT02706951|2946704|Superiority|The overall type I error prevalence of the primary and ranked key secondary endpoints for the two doses of upadacitinib were strongly controlled by means of a graphic multiple testing procedure.|Response Rate Difference|26.5|||<|0.001|2-Sided|95.0|17.5|35.6||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for stratification factor geographic region.|Response Rate Difference = Upadacitinib – Methotrexate||
1604680|NCT02706938|2946706|Other|McNemar's chi squared statistic|Risk Difference (RD)|-0.0263||||0.8084|2-Sided|95.0|-0.2651|0.2125||A priori threshold for statistical significance was 0.05|McNemar||||
1604681|NCT02706938|2946706|Other|One tail paired t test.|Mean Difference (Final Values)|-6.9131|Standard Deviation|32.5093||0.099|2-Sided|95.0|-17.5987|3.7724||A priori threshold for statistical significance was 0.05|t-test, 1 sided||||
1604682|NCT02706938|2946707|Other|McNemar's chi squared statistic|Risk Difference (RD)|-0.359||||0.0082|2-Sided|95.0|-0.6255|-0.0924||A priori threshold for statistical significance was 0.05|McNemar||||
1604683|NCT02706938|2946707|Other|One tail paired t test.|Mean Difference (Final Values)|1.3267|Standard Deviation|2.1604||0.0002|2-Sided|95.0|0.6263|2.027||A priori threshold for statistical significance was 0.05|t-test, 1 sided||||
1604684|NCT02706925|2946708|Superiority or Other (legacy)||Slope|1.3969|Standard Deviation|0.3965|||2-Sided|95.0|0.5563|2.2375|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.||
1604685|NCT02706925|2946708|Superiority or Other (legacy)||Slope|1.0771|Standard Deviation|0.0524|||2-Sided|95.0|0.9696|1.1845|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.||
1604686|NCT02706925|2946708|Superiority or Other (legacy)||Slope|1.2114|Standard Deviation|0.035|||2-Sided|95.0|1.1409|1.2818|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.||
1604687|NCT02706925|2946709|Superiority or Other (legacy)||Slope|1.1846|Standard Deviation|0.3328|||2-Sided|95.0|0.4791|1.89|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.||
1605191|NCT02696798|2947395|Superiority||LS Mean Difference (Final Values)|-0.172|Standard Error of the Mean|0.1319||0.194|2-Sided|95.0|-0.431|0.088|||Mixed Models Analysis||||
1604688|NCT02706925|2946709|Superiority or Other (legacy)||Slope|1.088|Standard Deviation|0.0843|||2-Sided|95.0|0.9128|1.2633|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.||
1604689|NCT02706925|2946709|Superiority or Other (legacy)||Slope|1.2951|Standard Deviation|0.0352|||2-Sided|95.0|1.2242|1.366|||||The model of dose proportionality was power model that describes the functional relationship between the dose and PK endpoints. Perfect dose proportionality would correspond to a slope of 1. Standard deviation is actually the standard error of slope.||
1604690|NCT02706873|2946737|Superiority||Response Rate Difference|33.0||||0.016|2-Sided|95.0|7.9|58.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604691|NCT02706873|2946737|Superiority||Response Rate Difference|34.6||||0.01|2-Sided|95.0|10.2|59.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604692|NCT02706873|2946737|Superiority||Response Rate Difference|36.2||||0.001|2-Sided|95.0|14.4|58.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604693|NCT02706873|2946738|Superiority||LS Mean Difference|-2.45||||0.022|2-Sided|95.0|-4.54|-0.35|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib – Methotrexate||
1604694|NCT02706873|2946738|Superiority||LS Mean Difference|-2.4||||0.022|2-Sided|95.0|-4.45|-0.35|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604695|NCT02706873|2946738|Superiority||LS Mean Difference|-1.69||||0.063|2-Sided|95.0|-3.47|0.09|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604696|NCT02706873|2946740|Superiority||Response Rate Difference|60.7|||<|0.001|2-Sided|95.0|39.9|81.5|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604697|NCT02706873|2946740|Superiority||Response Rate Difference|59.9|||<|0.001|2-Sided|95.0|38.8|81.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604698|NCT02706873|2946740|Superiority||Response Rate Difference|51.2|||<|0.001|2-Sided|95.0|32.5|70.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604699|NCT02706873|2946741|Superiority||LS Mean Difference|6.76|||<|0.001|2-Sided|95.0|3.33|10.2|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604700|NCT02706873|2946741|Superiority||LS Mean Difference|7.92|||<|0.001|2-Sided|95.0|4.66|11.19|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604701|NCT02706873|2946741|Superiority||LS Mean Difference|5.97|||<|0.001|2-Sided|95.0|3.15|8.8|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604702|NCT02706873|2946742|Superiority||LS Mean Difference|-0.75|||<|0.001|2-Sided|95.0|-0.99|-0.51|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604703|NCT02706873|2946742|Superiority||LS Mean Difference|-0.75|||<|0.001|2-Sided|95.0|-0.99|-0.51|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604704|NCT02706873|2946742|Superiority||LS Mean Difference|-0.54|||<|0.001|2-Sided|95.0|-0.75|-0.34|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604705|NCT02706873|2946743|Superiority||LS Mean Difference|-1.92|||<|0.001|2-Sided|95.0|-2.48|-1.36|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604706|NCT02706873|2946743|Superiority||LS Mean Difference|-1.86|||<|0.001|2-Sided|95.0|-2.42|-1.3|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604707|NCT02706873|2946743|Superiority||LS Mean Difference|-1.43|||<|0.001|2-Sided|95.0|-1.92|-0.95|||ANOVA|ANOVA model with Baseline value as covariate.|Difference = Upadacitinib - Methotrexate||
1604708|NCT02706873|2946744|Superiority||Response Rate Difference|64.3|||<|0.001|2-Sided|95.0|46.5|82.0|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604709|NCT02706873|2946744|Superiority||Response Rate Difference|51.9|||<|0.001|2-Sided|95.0|33.0|70.7|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604710|NCT02706873|2946744|Superiority||Response Rate Difference|34.5|||<|0.001|2-Sided|95.0|22.0|47.1|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604711|NCT02706873|2946745|Superiority||Response Rate Difference|50.0|||<|0.001|2-Sided|95.0|27.4|72.6|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604712|NCT02706873|2946745|Superiority||Response Rate Difference|45.2|||<|0.001|2-Sided|95.0|21.8|68.6|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604713|NCT02706873|2946745|Superiority||Response Rate Difference|38.6|||<|0.001|2-Sided|95.0|18.6|58.5|||Chi-squared||Response Rate Difference = Upadacitinib – Methotrexate||
1604714|NCT02706873|2946746|Superiority||Response Rate Difference|21.4||||0.086|2-Sided|95.0|-2.4|45.2|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604715|NCT02706873|2946746|Superiority||Response Rate Difference|28.0||||0.022|2-Sided|95.0|5.3|50.7|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604716|NCT02706873|2946746|Superiority|For the Japan sub-study, no multiplicity adjustments were applied and only nominal p-values were provided for all efficacy analyses.|Response Rate Difference|28.3||||0.004|2-Sided|95.0|7.7|48.9|||Chi-squared||Response Rate Difference = Upadacitinib - Methotrexate||
1604717|NCT02706873|2946747|Superiority||Response Rate Difference|31.2|||<|0.001|2-Sided|95.0|24.2|38.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate||
1604718|NCT02706873|2946747|Superiority||Response Rate Difference|26.0|||<|0.001|2-Sided|95.0|19.1|33.0||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate||
1605192|NCT02696798|2947395|Superiority||LS Mean Difference (Final Values)|-0.304|Standard Error of the Mean|0.1275||0.018|2-Sided|95.0|-0.555|-0.053|||Mixed Models Analysis||||
1604719|NCT02706873|2946748|Superiority||Response Rate Difference|19.4|||<|0.001|2-Sided|95.0|12.3|26.5||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate||
1604720|NCT02706873|2946748|Superiority||Response Rate Difference|20.3|||<|0.001|2-Sided|95.0|13.2|27.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate||
1604721|NCT02706873|2946749|Other||Response Rate Difference|22.9|||<|0.001|2-Sided|95.0|16.4|29.5||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate||
1604722|NCT02706873|2946749|Superiority||Response Rate Difference|18.5|||<|0.001|2-Sided|95.0|12.1|24.9||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate||
1604723|NCT02706873|2946750|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|11.6|||<|0.001|2-Sided|95.0|5.4|17.8||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate||
1604724|NCT02706873|2946750|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|9.8|||<|0.002|2-Sided|95.0|3.5|16.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate||
1604725|NCT02706873|2946751|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|4.42|||<|0.001|2-Sided|95.0|3.12|5.72||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate||
1604726|NCT02706873|2946751|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|3.72|||<|0.001|2-Sided|95.0|2.42|5.03||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate||
1604727|NCT02706873|2946752|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|32.8|||<|0.001|2-Sided|95.0|25.4|40.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate||
1604728|NCT02706873|2946752|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|27.8|||<|0.001|2-Sided|95.0|20.3|35.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate||
1604729|NCT02706873|2946753|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|32.2|||<|0.001|2-Sided|95.0|24.8|39.6||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate||
1604730|NCT02706873|2946753|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|Response Rate Difference|26.8|||<|0.001|2-Sided|95.0|19.3|34.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate||
1604731|NCT02706873|2946754|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.31|||<|0.001|2-Sided|95.0|-0.41|-0.21||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate||
1604732|NCT02706873|2946754|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.27|||<|0.001|2-Sided|95.0|-0.37|-0.17||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate||
1605193|NCT02696798|2947396|Superiority||LS Mean Difference (Final Values)|-17.841|Standard Error of the Mean|3.9018|<|0.001|2-Sided|95.0|-25.518|-10.163|||Mixed Models Analysis||||
1606392|NCT02651688|2950568|Superiority|||||||0.0027|||||||Wilcoxon rank-sum test||||
1604733|NCT02706873|2946755|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-1.19|||<|0.001|2-Sided|95.0|-1.4|-0.99||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate||
1604734|NCT02706873|2946755|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for EU/EMA regulatory purposes.|LS Mean Difference|-0.92|||<|0.001|2-Sided|95.0|-1.12|-0.71||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate||
1604735|NCT02706873|2946756|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|4.34|||<|0.001|2-Sided|95.0|3.09|5.59||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate||
1604736|NCT02706873|2946756|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|4.25|||<|0.001|2-Sided|95.0|3.0|5.5||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate||
1604737|NCT02706873|2946757|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|Response Rate Difference|26.4|||<|0.001|2-Sided|95.0|19.0|33.9||The nominal p-value is reported|Chi-squared, Corrected|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|||Response Rate Difference = Upadacitinib - Methotrexate
1604738|NCT02706873|2946757|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|Response Rate Difference|25.0|||<|0.001|2-Sided|95.0|17.6|32.4||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate||
1604739|NCT02706873|2946758|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.37|||<|0.001|2-Sided|95.0|-0.47|-0.28||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate||
1604740|NCT02706873|2946758|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.34|||<|0.001|2-Sided|95.0|-0.44|-0.25||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate||
1604741|NCT02706873|2946759|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-1.01|||<|0.001|2-Sided|95.0|-1.21|-0.8||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib - Methotrexate||
1604742|NCT02706873|2946759|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure. This endpoint was a ranked key secondary endpoint for US/FDA and Japan/PMDA regulatory purposes.|LS Mean Difference|-0.88|||<|0.001|2-Sided|95.0|-1.09|-0.67||The nominal p-value is reported|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|||
1604743|NCT02706873|2946760|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|LS Mean Difference|-0.59|||<|0.001|2-Sided|95.0|-0.91|-0.27||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment and geographic region as fixed factors and Baseline value as the covariate.|Difference = Upadacitinib – Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.|
1604744|NCT02706873|2946760|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Least Squares (LS) Mean Difference|-0.53|||<|0.001|2-Sided|95.0|-0.85|-0.2||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, geographic region as fixed factors and baseline value as the covariate.|Difference = Upadacitinib – Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.|
1605194|NCT02696798|2947396|Superiority||LS Mean Difference (Final Values)|-20.816|Standard Error of the Mean|3.7463|<|0.001|2-Sided|95.0|-28.187|-13.444|||Mixed Models Analysis||||
1606393|NCT02651688|2950568|Superiority|||||||0.0034|||||||Wilcoxon rank-sum test||||
1604745|NCT02706873|2946761|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|22.9|||<|0.001|2-Sided|95.0|15.7|30.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib – Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.|
1604746|NCT02706873|2946761|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|21.6|||<|0.001|2-Sided|95.0|14.3|28.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib – Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.|
1604747|NCT02706873|2946762|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|31.5|||<|0.001|2-Sided|95.0|24.5|38.5|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib - Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.|
1604748|NCT02706873|2946762|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|29.8|||<|0.001|2-Sided|95.0|22.8|36.8||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib – Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.|
1604749|NCT02706873|2946763|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|28.0|||<|0.001|2-Sided|95.0|20.6|35.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib – Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.|
1604750|NCT02706873|2946763|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two upadacitinib doses (15 mg and 30 mg) was controlled using a graphical multiple testing procedure defined separately for US/FDA, European Union/European Medicines Agency and Japan/Pharmaceuticals and Medical Devices Agency regulatory purposes.|Response Rate Difference|23.7|||<|0.001|2-Sided|95.0|16.3|31.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for geographic region (North America, South/central America, Western Europe, Eastern Europe, Asia/other).|Response Rate Difference = Upadacitinib – Methotrexate|For the global analysis, comparisons of the primary and key secondary efficacy endpoints were made between the upadacitinib 15 mg and 30 mg groups versus the methotrexate group.|
1604751|NCT02706847|2946764|Superiority||Response Rate Difference|14.2|||<|0.001|2-Sided|95.0|6.1|22.3||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo||
1604752|NCT02706847|2946764|Superiority||Response Rate Difference|16.8|||<|0.001|2-Sided|95.0|8.5|25.1||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo||
1604753|NCT02706847|2946765|Superiority||Response Rate Difference|16.5|||<|0.001|2-Sided|95.0|9.1|23.9||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo||
1604754|NCT02706847|2946765|Superiority||Response Rate Difference|5.1|||<|0.11|2-Sided|95.0|-1.1|11.2||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo||
1604755|NCT02706847|2946766|Superiority||Response Rate Difference|23.9|||<|0.001|2-Sided|95.0|15.1|32.7||The nominal p-value is reported|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib - Placebo||
1606394|NCT02651688|2950569|Superiority|||||||0.2723|||||||Wilcoxon rank-sum test||||
1604757|NCT02706847|2946767|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.63|||<|0.001|2-Sided|95.0|2.89|6.36||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib – Placebo||
1604758|NCT02706847|2946767|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean DIfference|3.44|||<|0.001|2-Sided|95.0|1.72|5.15||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib – Placebo||
1604759|NCT02706847|2946768|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.25|||<|0.001|2-Sided|95.0|-0.38|-0.13||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib – Placebo||
1604760|NCT02706847|2946768|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.22|||<|0.001|2-Sided|95.0|-0.34|-0.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib – Placebo||
1604761|NCT02706847|2946769|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.28|||<|0.001|2-Sided|95.0|-1.56|-0.99||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib – Placebo||
1604762|NCT02706847|2946769|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.29|||<|0.001|2-Sided|95.0|-1.57|-1.01||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior biological DMARD use (stratum 1 vs stratum 2) and baseline value as covariates.|Treatment Difference = Upadacitinib – Placebo||
1604763|NCT02706847|2946770|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.2|||<|0.001|2-Sided|95.0|19.0|37.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib – Placebo||
1604764|NCT02706847|2946770|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|29.1|||<|0.001|2-Sided|95.0|19.9|38.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib – Placebo||
1604765|NCT02706847|2946771|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.0|||<|0.001|2-Sided|95.0|17.8|38.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib – Placebo||
1604766|NCT02706847|2946771|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|36.2|||<|0.001|2-Sided|95.0|26.2|46.2||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use (stratum 1 vs stratum 2).|Response Rate Difference = Upadacitinib – Placebo||
1604767|NCT02706834|2946772|Non-Inferiority or Equivalence|Bioequivalence interval of 0.80 to 1.25|Point estimate|0.896|||||2-Sided|90.0|0.833|0.964|||||Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted|Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means and ratios of geometric means on the original scale.|
1604768|NCT02706834|2946779|Non-Inferiority or Equivalence|Bioequivalence interval of 0.80 to 1.25|Point estimate|0.43|||||2-Sided|90.0|0.38|0.487|||||Exponentiated Least Square Means TAK-828 100 mg Fed/TAK-828 100 mg Fasted|Food Effect: A linear mixed effect model on the natural log (ln)-transformed parameters was performed with dosing condition as a fixed effect and participant as a random effect using the Kenward-Roger estimation for computing the denominator degrees of freedom. The least squares means and difference of least squared means for the ln-transformed parameters were exponentiated to obtain the geometric means on the original scale.|
1604769|NCT02706717|2946782|Superiority|||||||0.15|||||||Kruskal-Wallis||||
1604770|NCT02706717|2946799|Superiority||Mean Difference (Net)|-0.02||||0.41|2-Sided|95.0|-0.08|0.04|||t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Visbiome ES mean minus placebo mean.||
1604775|NCT02706327|2946815|Other|||||||0.848|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.|
1604776|NCT02706327|2946816|Other|||||||0.842|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.|
1604777|NCT02706327|2946817|Other|||||||0.895|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.|
1604778|NCT02706327|2946818|Other|||||||0.547|||||||Kruskal-Wallis|||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not.|
1604779|NCT02706327|2946819|Other||||||<|0.001||||||A post-hoc test was used with Bonferroni correction and adjusted p-value was 0.016.|Kruskal-Wallis|Effect sizes (Cohen’s d) were calculated for significant differences.||Normality of the distribution was investigated by skewness-kurtosis, histogram graphics, normality tests and plots before the statistical tests were performed. Group comparisons were tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not. A post-hoc test was used with Bonferroni correction.|
1604780|NCT02705716|2946849|Other||Least Square (LS) Mean Difference|-0.12||||0.5191|2-Sided|95.0|-0.497|0.252|||ANCOVA|From ANCOVA Model, Response: change from baseline in Schiff sensitivity score Factors: treatment & site Covariates: baseline Schiff sensitivity score|Difference is first named dentifrice minus second named dentifrice such that a negative difference favors first named dentifrice.||
1604781|NCT02705625|2946850|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in CTX-II score at Week 26.|Mean Difference (Final Values)|-193.0|||<|0.0001|2-Sided|95.0|-262.0|-124.0||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-II score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by- time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-II score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604782|NCT02705625|2946850|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in CTX-II score at Week 26.|Mean Difference (Final Values)|-270.0|||<|0.0001|2-Sided|95.0|-339.0|-201.0||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-II score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-II score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604783|NCT02705625|2946851|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in CTX-I score at Week 26.|Mean Difference (Final Values)|-0.145|||<|0.0001|2-Sided|95.0|-0.193|-0.0983||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-I score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-I score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604784|NCT02705625|2946851|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in CTX-I score at Week 26.|Mean Difference (Final Values)|-0.254|||<|0.0001|2-Sided|95.0|-0.302|-0.206||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: CTX-I score is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline CTX-I score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604785|NCT02705625|2946852|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC stiffness score at Week 26.|Mean Difference (Final Values)|-4.95||||0.0861|2-Sided|95.0|-12.1|2.17||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Stiffness score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline WOMAC stiffness score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604811|NCT02702999|2946952|Superiority||Risk Ratio (RR)|3.9|||||2-Sided|95.0|0.9|18.0|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).||
1604786|NCT02705625|2946852|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC stiffness score at Week 26.|Mean Difference (Final Values)|-3.07||||0.2|2-Sided|95.0|-10.2|4.1||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Stiffness score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Stiffness score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604787|NCT02705625|2946853|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC difficulty score at Week 26.|Mean Difference (Final Values)|-3.78||||0.1262|2-Sided|95.0|-10.3|2.72||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Difficulty score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC difficulty score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604788|NCT02705625|2946853|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC difficulty score at Week 26.|Mean Difference (Final Values)|-1.84||||0.2898|2-Sided|95.0|-8.38|4.7||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Difficulty score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Difficulty score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604789|NCT02705625|2946854|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in WOMAC Pain score at Week 26.|Mean Difference (Final Values)|-4.55||||0.0753|2-Sided|95.0|-10.8|1.67||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Pain score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic (Yes/No) and random effect for clinical site. Baseline WOMAC Pain score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604790|NCT02705625|2946854|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in WOMAC Pain score at Week 26.|Mean Difference (Final Values)|-1.77||||0.2887|2-Sided|95.0|-8.02|4.48||p-values reported are unadjusted p-values for tests of significance for the lower one-tailed alternative hypothesis Ha: Reduction in WOMAC Pain score is higher in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time,baseline analgesic user (Yes/No), and random effect for clinical site. Baseline WOMAC Pain score was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604791|NCT02705625|2946855|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in MRI of cartilage thickness (Femur Region) at Week 26.|Mean Difference (Final Values)|0.0761||||0.0225|2-Sided|95.0|0.00173|0.15||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: MRI of cartilage thinning (Femur Region) is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline MRI of cartilage thickness was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604792|NCT02705625|2946855|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in MRI of cartilage thickness (Femur Region) at Week 26.|Mean Difference (Final Values)|0.0436||||0.1253|2-Sided|95.0|-0.031|0.118||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: MRI of cartilage thinning (Femur Region) is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline MRI of cartilage thickness was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604812|NCT02702999|2946953|Superiority||Risk Ratio (RR)|3.9|||||2-Sided|95.0|0.9|18.0|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).||
1605195|NCT02696798|2947397|Superiority||LS Mean Difference (Final Values)|-7.27|Standard Error of the Mean|1.978|<|0.001|2-Sided|95.0|-11.2|-3.4|||ANCOVA||||
1605196|NCT02696798|2947397|Superiority||LS Mean Difference (Final Values)|-6.29|Standard Error of the Mean|1.896|<|0.001|2-Sided|95.0|-10.0|-2.5|||ANCOVA||||
1604793|NCT02705625|2946856|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 100 mg versus placebo with respect to mean change from baseline in knee joint MRI bone area at Week 26.|Mean Difference (Final Values)|-15.4||||0.0023|2-Sided|95.0|-26.0|-4.83||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: bone area increase is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline knee joint MRI bone area was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604794|NCT02705625|2946856|Superiority|One model is fit for all comparison groups (MIV-711 200 mg, MIV-711 100 mg and placebo). This analysis reports the contrast that compares 200 mg versus placebo with respect to mean change from baseline in knee joint MRI bone area at Week 26.|Mean Difference (Final Values)|-14.7||||0.0036|2-Sided|95.0|-25.3|-4.02||p-values reported are unadjusted p-values for tests of significance for the upper one-tailed alternative hypothesis Ha: bone area increase is lower in the active treatment arm compared to placebo.|Mixed Models Analysis|||"A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment-by-time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline knee joint MRI bone area was included as a covariate for adjustment.~An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model."|
1604795|NCT02705625|2946857|Superiority|"For the primary endpoint, the Type I error for the tests of the two doses was protected by performing a fixed-sequence multiple-testing procedure in the following order:~Step 1: 200 mg versus placebo Step 2: 100 mg versus placebo The second step was only considered as confirmatory provided the previous step was significant at a one-sided 5%-level (p<0.05).~If the previous step was not significant, the analysis of the following step was considered descriptive."|Mean Difference (Final Values)|-0.0761||||0.4055|2-Sided|95.0|-0.703|0.55||The p-values reported is from Step 1 (comparing 200 mg versus placebo). The corresponding p-value from Step 2 (comparing 100 mg versus placebo) was 0.1458.|Mixed Models Analysis|||A linear mixed model based on the mITT population was used. The model included fixed factors for treatment, time (measured in weeks), the interaction for treatment by time, baseline analgesic user (Yes/No), and random effect for clinical site. Baseline NRS was included as a covariate for adjustment. An unstructured covariance matrix was used to model the covariance pattern in the mixed effects model.|
1604796|NCT02704091|2946889|Superiority||LS Mean Difference|-0.12||||0.0465|2-Sided|95.0|-0.24|0.0|||ANCOVA|||Comparison between the 2 treatment groups for number of watery stools for the overall time period, based on an ANCOVA method for repeated measurements. The model included the number of watery stools 24 hours before randomisation (baseline) as covariate, treatment, time point (12-hour period), the treatment by time point interaction as fixed effects and participant as random effect.|
1604797|NCT02704091|2946890|Superiority||Least Squares (LS) Mean Difference|-0.04||||0.4294|2-Sided|95.0|-0.15|0.07|||ANCOVA|||Comparison between the 2 treatment groups for number of stools for the overall time period, based on an analysis of covariance (ANCOVA) method for repeated measurements. The model included the number of stools 24 hours before randomisation (baseline) as covariate, treatment, time point (12-hour period), the treatment by time point interaction as fixed effects and participant as random effect.|
1604798|NCT02704091|2946891|Superiority||||||=|0|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from first study treatment intake to last watery stool, analysed using the Gehan-Wilcoxon test.|
1604799|NCT02704091|2946892|Superiority||||||=|0|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from diarrhoea onset to first formed stool, analysed using the Gehan-Wilcoxon test.|
1604800|NCT02704091|2946893|Superiority||||||=|0|||||||Gehan-Wilcoxon test|||Comparison between the 2 treatment groups for time from diarrhoea onset to recovery, analysed using the Gehan-Wilcoxon test.|
1604801|NCT02704091|2946894|Superiority|"The following Null-hypothesis was tested:~H0: λA(t) = λB (t) versus H1: λA(t) ≠ λB (t), where λ(t) represents the hazard at time t, A=diosmectite and B=placebo."|||||=|0|||||||Wilcoxon-Gehan test|||The primary analysis tested the equality of time to recovery between the 2 treatment groups, applying the 2-sided Gehan-Wilcoxon test (α=5%).|
1604802|NCT02703987|2946895|Superiority||Mean Difference (Net)|9.56|Standard Error of the Mean|4.85||0.0609|2-Sided|95.0|-0.48|19.6|||Mixed Models Analysis||||
1604803|NCT02703987|2946896|Superiority||Mean Difference (Net)|0.34|Standard Error of the Mean|0.18||0.0714|2-Sided|95.0|-0.03|0.71|||Mixed Models Analysis||||
1604804|NCT02703987|2946897|Superiority||Mean Difference (Net)|0.32|Standard Error of the Mean|0.17||0.0801|2-Sided|95.0|-0.04|0.67|||Mixed Models Analysis||||
1604805|NCT02703636|2946909|Other|The MMRM model contained visit as a fixed effect, baseline MMSE score as a covariate and patient as a random effect.|Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.259||0.175|2-Sided|95.0|-0.87|0.16|||t-test, 2 sided||change at week 24||
1604806|NCT02703467|2946929|Superiority||||||>|0.05||||||calculated|t-test, 2 sided||||
1604807|NCT02702999|2946948|Superiority||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.4|2.3|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).||
1604808|NCT02702999|2946949|Superiority||Risk Ratio (RR)|0.2|||||2-Sided|95.0|0.03|2.1|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).||
1604809|NCT02702999|2946950|Superiority||Risk Ratio (RR)|5.4|||||2-Sided|95.0|1.2|23.7|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).||
1604810|NCT02702999|2946951|Superiority||Risk Ratio (RR)|1.9|||||2-Sided|95.0|0.4|10.5|||||The intervention arm and control arm were compared using a log binomial (or Poisson in case of nonconvergence) model with the intervention arm as a covariate to estimate relative risk and 95% confidence interval (CI).||
1606395|NCT02651688|2950569|Superiority|||||||0.296|||||||Wilcoxon rank-sum test||||
1604813|NCT02702401|2946959|Other||Hazard Ratio (HR)|0.688||||0.0011|2-Sided|95.0|0.54|0.877||One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Log Rank||Cox regression model with Efron’s method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level||
1604814|NCT02702401|2946961|Other||Difference in Percent|13.8|||||2-Sided|95.0|7.7|19.5|||||Miettinen & Nurminen method stratified by geographic region, macrovascular invasion and alfa-fetoprotein level||
1604815|NCT02702401|2946962|Superiority||Hazard Ratio (HR)|0.781||||0.0238|2-Sided|95.0|0.611|0.998|||Log Rank|One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Cox regression model with Efron’s method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level||
1604816|NCT02702401|2946963|Superiority||Hazard Ratio (HR)|0.775||||0.0186|2-Sided|95.0|0.609|0.987|||Log Rank|One-sided p-value stratified by geographic region, macrovascular invasion and alfa-fetoprotein level.|Cox regression model with Efron’s method (treatment as covariate) stratified by geographic region, macrovascular invasion and alfa-fetoprotein level||
1604817|NCT02702193|2946973|Superiority||Slope|-0.24|Standard Error of the Mean|0.11|<|0.05|2-Sided|95.0|||||Generalized Estimating Equations (GEE)|GEE allowed the examination of trajectories from baseline through the 12 month follow-up.||To determine sample size for the grant proposal we conducted simulation studies in Mplus (Muthén & Muthén, 2010) following the procedure described by Muthén and Muthén (2002). Each simulation created 10,000 datasets, assuming a medium-size (d = .5) intervention effect, and attrition of 10% at each assessment. For α= .05, the power estimate was at or above 80% with a sample of 172 mothers.|
1604818|NCT02702011|2946974|Superiority or Other||Mean Difference (Net)|98.11|Standard Error of the Mean|11.01|<|0.0001|2-Sided|95.0|75.91|120.31|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 25 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.|
1604819|NCT02702011|2946974|Superiority or Other||Mean Difference (Net)|81.19|Standard Error of the Mean|11.1|<|0.0001|2-Sided|95.0|58.8|103.58|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 10 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.|
1604820|NCT02702011|2946974|Superiority or Other||Mean Difference (Net)|65.1|Standard Error of the Mean|10.81|<|0.0001|2-Sided|95.0|43.29|86.9|||ANCOVA||Mean Difference was calculated as: (mean change from baseline in 24 hour UGE at Day 7 in Empagliflozin 2.5 mg group) - (mean change from baseline in 24 hour UGE at Day 7 in Placebo group)|An analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline as a linear covariate was fitted to the change from baseline of 24 hour UGE (g/24h) on Day 7, where baseline refers to the last observation prior to the first intake of any randomised trial medication.|
1604821|NCT02701985|2946984|Superiority||Mean Difference (Final Values)|0.06||||0.6429||95.0|-0.21|0.34|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.|
1604822|NCT02701985|2946985|Superiority||Median Difference (Final Values)|0.87||||0.4266||95.0|-1.3|3.03|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.|
1604823|NCT02701985|2946989|Superiority||Difference in Adjusted Means|-0.33||||0.8134||95.0|-2.43|3.08|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable|
1604824|NCT02701985|2946990|Superiority||Difference in Adjusted Means|-2.06||||0.2846||95.0|-5.87|1.75|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable|
1604825|NCT02701985|2946991|Superiority||Difference in Adjusted Means|-0.22||||0.6077|2-Sided|95.0|-1.08|0.64|||Mixed Model of Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.|
1604826|NCT02701985|2946992|Superiority||Difference in Adjusted Means|-0.13||||0.8905|2-Sided|95.0|-2.04|1.78|||Mixed Model for Repeated Measures|||A Mixed Model for Repeated Measures (MMRM) approach incorporating all observed data up to 12 weeks of treatment was used. The MMRM included the absolute change from baseline as the dependent variable.|
1604827|NCT02701985|2946993|Other||Difference in Response Rates|1.14||||0.9877|2-Sided|95.0|-23.92|26.19|||Chi-square with Schouten Correction|||The proportion of patients who have ≥ 1 point reduction from baseline in ESSPRI score after 12 weeks of treatment was compared between the two treatment arms using a Pearson Chi-square test (two sided p-values, alpha 0.05). The difference in proportions and corresponding 95% CI are provided. Patients with missing data at Week 12 will be treated as non-responders in the analysis.|
1604828|NCT02701985|2946994|Other||Difference in Response Rates|4.27||||0.7955|2-Sided|95.0|-20.55|29.08|||Chi-square with Schouten Correction|||The proportion of patients who have ≥ 3 point reduction from baseline in ESSDAI score after 12 weeks of treatment was compared between the two treatment arms using a Pearson Chi-square test (two sided p-values, alpha 0.05). The difference in proportions and corresponding 95% confidence interval (CI) are provided. Patients with missing data at Week 12 will be treated as non-responders in the analysis.|
1604829|NCT02701634|2947015|Superiority||Hazard Ratio (HR)|1.09||||0.8|2-Sided|95.0|0.55|2.18||P-value was calculated using the log-rank test and stratified for disease severity and usage of calcineurin inhibitor or mycophenolate mofetil (MMF).|Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for disease severity and usage of calcineurin inhibitor or MMF||
1604834|NCT02701387|2947034|Superiority or Other||||||<|0.01||||||A 2-factor (implant type x time interval) nonparametric analysis for longitudinal data (Brunner et al. 2002) was used to compare test and control implants across time (baseline + four intervals). The R package “nparLD” was used (Noguchi et al. 2012).|nonparametric for longitudinal|||Comparison of ISQ over time. Due to the high number of intervals (T0-T8) relative to the number of observations, data were combined for analysis purposes into 5 comparable intervals as follows: Baseline (T0, unchanged); Tr1=Average of follow-up weeks T1 and T2, Tr2=Average of follow-up weeks T3 and T4; Tr3=Average of follow-up weeks T5 and T6; Tr4=Average of follow-up weeks T7 and T8|
1604835|NCT02701049|2947096|Other|Among 109,994 patients who entered the ED during Mode 1, 19,742 had SOGI collected (18%). Among 88,143 patients who entered the ED during Mode 2, 3,630 had SOGI collected (4%).||||||||||||||||Historical controls included all patients entering participating EDs as identified by the Electronic Health Record.|Results were compared to historical control population from an electronic health record database, no other data were collected for these participants.
1604836|NCT02700815|2947120|Superiority||Mean Difference (Net)|2.02|Standard Error of the Mean|0.95||0.0339|2-Sided|95.0|0.15|3.88|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.|
1604837|NCT02700815|2947120|Superiority||Mean Difference (Net)|0.28|Standard Error of the Mean|0.949||0.7672|2-Sided|95.0|-1.58|2.15|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.|
1604838|NCT02700815|2947120|Superiority||Mean Difference (Net)|1.65|Standard Error of the Mean|1.339||0.2193|2-Sided|95.0|-0.98|4.27|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.|
1604839|NCT02700815|2947121|Superiority||Mean Difference (Net)|0.76|Standard Error of the Mean|0.602||0.2047|2-Sided|95.0|-0.42|1.95|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.|
1604840|NCT02700815|2947121|Superiority||Mean Difference (Net)|0.31|Standard Error of the Mean|0.601||0.6094|2-Sided|95.0|-0.87|1.49|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.|
1604841|NCT02700815|2947121|Superiority||Mean Difference (Net)|-0.13|Standard Error of the Mean|0.844||0.881|2-Sided|95.0|-1.78|1.53|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in PA from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline PA and baseline PA by time interaction.|
1604842|NCT02700815|2947122|Superiority||Mean Difference (Net)|-1.12|Standard Error of the Mean|0.223|<|0.0001|2-Sided|95.0|-1.56|-0.68|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.|
1604843|NCT02700815|2947122|Superiority||Mean Difference (Net)|0.2|Standard Error of the Mean|0.223|<|0.3726|2-Sided|95.0|-0.24|0.64|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.|
1604844|NCT02700815|2947122|Superiority||Mean Difference (Net)|-1.05|Standard Error of the Mean|0.313|<|0.0008|2-Sided|95.0|-1.67|-0.44|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.|
1604845|NCT02700815|2947123|Superiority||Odds Ratio (OR)|2.125||||0.0004|2-Sided|95.0|1.4|3.22|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.|
1604931|NCT02698371|2947258|Equivalence|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance from baseline to 24 month follow-up;|
1604846|NCT02700815|2947123|Superiority||Odds Ratio (OR)|0.833||||0.3479|2-Sided|95.0|0.57|1.22|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.|
1604847|NCT02700815|2947123|Superiority||Odds Ratio (OR)|1.729||||0.0643|2-Sided|95.0|0.97|3.09|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 50% from baseline between placebo and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.|
1604848|NCT02700815|2947124|Superiority||Odds Ratio (OR)|1.629||||0.0122|2-Sided|95.0|1.11|2.39|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between diclofenac and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.|
1604849|NCT02700815|2947124|Superiority||Odds Ratio (OR)|0.732||||0.1206|2-Sided|95.0|0.49|1.09|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between capsaicin and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.|
1604850|NCT02700815|2947124|Superiority||Odds Ratio (OR)|1.882||||0.0202|2-Sided|95.0|1.1|3.21|||Regression, Logistic|Logistic regression model include country and application site as covariates. Odds ratio was calculated as combination treatment/individual treatment.||A logistic regression was used to compare change in number of patients with a decrease in POMwp of at least 30% from baseline between placebo and combination therapy diclofenac + capsaicin. The likelihood-ratio test was used to test for differences between treatments.|
1604851|NCT02700815|2947125|Superiority||Mean Difference (Net)|-0.68|Standard Error of the Mean|0.169|<|0.0001|2-Sided|95.0|-1.01|-0.35|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between diclofenac and combination therapy diclofenac + capsaicin|
1604852|NCT02700815|2947125|Superiority||Mean Difference (Net)|0.32|Standard Error of the Mean|0.169|<|0.0622|2-Sided|95.0|-0.02|0.65|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between capsaicin and combination therapy diclofenac + capsaicin|
1604853|NCT02700815|2947125|Superiority||Mean Difference (Net)|-0.5|Standard Error of the Mean|0.238|<|0.0347|2-Sided|95.0|-0.97|-0.04|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-120 h) between placebo and combination therapy diclofenac + capsaicin|
1604854|NCT02700815|2947126|Superiority||Mean Difference (Net)|-0.56|Standard Error of the Mean|0.157||0.0004|2-Sided|95.0|-0.87|-0.25|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between diclofenac and combination therapy diclofenac + capsaicin|
1604855|NCT02700815|2947126|Superiority||Mean Difference (Net)|0.3|Standard Error of the Mean|0.157||0.0564|2-Sided|95.0|-0.01|0.61|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between capsaicin and combination therapy diclofenac + capsaicin|
1604856|NCT02700815|2947126|Superiority||Mean Difference (Net)|-0.37|Standard Error of the Mean|0.221||0.0956|2-Sided|95.0|-0.8|0.07|||ANCOVA|ANCOVA includes treatment, country, and application site (back/neck) as fixed effects, and baseline POMwp as a continuous covariate.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|An analysis of covariance (ANCOVA) was used to compare POMwp AUC(0-72 h) between placebo and combination therapy diclofenac + capsaicin|
1604857|NCT02700815|2947127|Superiority||Mean Difference (Net)|-0.72|Standard Error of the Mean|0.197||0.0003|2-Sided|95.0|-1.1|-0.33|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between diclofenac and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.|
1604858|NCT02700815|2947127|Superiority||Mean Difference (Net)|0.21|Standard Error of the Mean|0.197||0.2886|2-Sided|95.0|-0.18|0.6|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between capsaicin and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.|
1604932|NCT02698371|2947258|Equivalence|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC-SE (G1) and MM-SE (G4G6) adhesives result in similar restoration retention rates;|
1605197|NCT02696798|2947398|Superiority||LS Mean Difference (Final Values)|-2.17|Standard Error of the Mean|0.534|<|0.001|2-Sided|95.0|-3.2|-1.1|||ANCOVA||||
1604859|NCT02700815|2947127|Superiority||Mean Difference (Net)|-0.6|Standard Error of the Mean|0.277||0.0303|2-Sided|95.0|-1.15|-0.06|||Mixed Models Analysis||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|A Mixed Model Repeat Measures (MMRM) analysis was used to compare change in POMwp from baseline between placebo and combination therapy diclofenac + capsaicin. MMRM model included fixed effects of treatment, country, application site (back/neck), time and fixed covariates of baseline POMwp and baseline POMwp by time interaction.|
1604860|NCT02700412|2947128|Other|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure severity scores over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure severity scores between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure severity scores was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure severity score outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure severity relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.
1604861|NCT02700412|2947129|Other|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure frequency over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure frequency between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure frequency was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure frequency outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure frequency relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.
1604862|NCT02699099|2947198|Non-Inferiority|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seropositivity rates of the anti-yellow fever antibody , being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|0.55|||||2-Sided|95.0|-2.31|3.67||||||Difference in seropositivity rates against Yellow Fever antibodies: To demonstrate the non-inferiority of the antibody response to the YF vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.|
1604863|NCT02699099|2947201|Non-Inferiority|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seroconversion rates of the anti-rubella antibody, being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|0.5|||||2-Sided|95.0|-1.29|2.8||||||"Difference in seroconversion rates against Rubella antibodies: To demonstrate the non-inferiority of the antibody response to the rubella vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered.~with SB257049 versus administration without SB257049."|
1604864|NCT02699099|2947204|Non-Inferiority|Non-inferiority was defined as the upper limit of the 95% confidence interval (CI) for the difference in seroconversion rate of the anti-measles antibody, being below 10% for the two groups (Control Group minus Coad Group).|Difference in percentage|2.07|||||2-Sided|95.0|-1.27|5.92||||||Difference in seroconversion rates against measles antibodies: To demonstrate the non-inferiority of the antibody response to the measles vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.|
1604865|NCT02699099|2947209|Non-Inferiority|Non-inferiority (1 month post-Dose 3 of SB257049) was defined as the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio (RTS,S group/Coad group) for anti-CS, being below a limit of 2.|Geometric Mean Ratio|0.93|||||2-Sided|95.0|0.81|1.07||||||Adjusted GMC ratios for anti-CS antibody: To demonstrate the non-inferiority of the antibody response to the CS antigen when SB257049 is co-administered with YF vaccine and a combined measles and rubella vaccine versus SB257049 administered alone.|
1604866|NCT02698371|2947240|Equivalence|An alpha value of 0.05 was considered||||||0.918||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.|
1604867|NCT02698371|2947240|Equivalence|An alpha value of 0.05 was considered||||||0.257||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.|
1604868|NCT02698371|2947240|Equivalence|An alpha value of 0.05 was considered||||||0.132||||||Applied for rows/categories No Evidence vs Evidence of Gingival Bleeding-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Gingival Bleeding performance at 24 month follow-up recall.|
1604869|NCT02698371|2947241|Equivalence|An alpha value of 0.05 was considered||||||0.334||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.|
1605198|NCT02696798|2947398|Superiority||LS Mean Difference (Final Values)|-1.95|Standard Error of the Mean|0.512|<|0.001|2-Sided|95.0|-3.0|-0.9|||ANCOVA||||
1604870|NCT02698371|2947241|Equivalence|An alpha value of 0.05 was considered||||||0.317||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.|
1604871|NCT02698371|2947241|Equivalence|An alpha value of 0.05 was considered||||||0.157||||||Applied for rows/categories No Evidence vs Evidence of Secondary Caries-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Secondary Caries performance at 24 month follow-up recall.|
1604872|NCT02698371|2947242|Equivalence|An alpha value of 0.05 was considered||||||0.99||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.|
1604873|NCT02698371|2947242|Equivalence|An alpha value of 0.05 was considered||||||0.18||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.|
1604874|NCT02698371|2947242|Equivalence|An alpha value of 0.05 was considered||||||0.102||||||Applied for rows/categories No Evidence vs Evidence of Postoperative Sensitivity-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Postoperative Sensitivity performance at 24 month follow-up recall.|
1604875|NCT02698371|2947243|Equivalence|An alpha value of 0.05 was considered||||||0.211||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.|
1604876|NCT02698371|2947243|Equivalence|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.|
1604877|NCT02698371|2947243|Equivalence|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for rows/categories alfa/bravo/charlie/delta of Marginal Integrity-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Integrity performance at 24 month follow-up recall.|
1604878|NCT02698371|2947244|Equivalence|An alpha value of 0.05 was considered||||||0.04||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Retention performance at 24 month follow-up recall.|
1604879|NCT02698371|2947244|Equivalence|An alpha value of 0.05 was considered||||||0.02||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Retention performance at 24 month follow-up recall.|
1604880|NCT02698371|2947244|Equivalence|An alpha value of 0.05 was considered||||||0.02||||||Applied for rows/categories alfa/bravo/charlie of Retention-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Retention performance at 24 month follow-up recall.|
1604881|NCT02698371|2947245|Equivalence|An alpha value of 0.05 was considered||||||0.403||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Color Match performance at 24 month follow-up recall.|
1604882|NCT02698371|2947245|Equivalence|An alpha value of 0.05 was considered||||||0.317||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Color Match performance at 24 month follow-up recall.|
1604883|NCT02698371|2947245|Equivalence|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Color Match-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Color Match performance at 24 month follow-up recall.|
1604933|NCT02698371|2947258|Equivalence|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC-SE (G1) and MM-SE(G4G6) result in similar restorations (aesthetic, functional and biologic) success rates;|
1604884|NCT02698371|2947246|Equivalence|An alpha value of 0.05 was considered||||||0.885||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.|
1604885|NCT02698371|2947246|Equivalence|An alpha value of 0.05 was considered||||||0.034||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.|
1604886|NCT02698371|2947246|Equivalence|An alpha value of 0.05 was considered||||||0.011||||||Applied for rows/categories alfa/bravo/charlie of Marginal Discoloration-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Discoloration performance at 24 month follow-up recall.|
1604887|NCT02698371|2947247|Equivalence|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.|
1604888|NCT02698371|2947247|Equivalence|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.|
1604889|NCT02698371|2947247|Equivalence|An alpha value of 0.05 was considered||||||1||||||Applied for rows/categories alfa/bravo/charlie of Surface Staining-USPHS comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Surface Staining performance at 24 month follow-up recall.|
1604890|NCT02698371|2947248|Equivalence|An alpha value of 0.05 was considered||||||0.592||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.|
1604891|NCT02698371|2947248|Equivalence|An alpha value of 0.05 was considered||||||0.107||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.|
1604892|NCT02698371|2947248|Equivalence|An alpha value of 0.05 was considered||||||0.02||||||Applied for all rows/Categories (graded on a 5-point scale) of Tooth Integrity (enamel cracks)-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Tooth Integrity (enamel cracks) performance at 24 month follow-up recall.|
1604893|NCT02698371|2947249|Equivalence|An alpha value of 0.05 was considered||||||0.575||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion & Abfraction-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.|
1604894|NCT02698371|2947249|Equivalence|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion, Abfraction-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.|
1604895|NCT02698371|2947249|Equivalence|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Recurrence of Caries, Erosion, Abfraction-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Recurrence of Caries, Erosion, Abfraction performance at 24 month follow-up recall.|
1604896|NCT02698371|2947250|Equivalence|An alpha value of 0.05 was considered||||||0.918||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.|
1604934|NCT02698371|2947258|Equivalence|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 – Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance between baseline and 24 month follow-up;|
1606396|NCT02651688|2950570|Superiority|||||||0.623|||||||Wilcoxon rank-sum test||||
1604897|NCT02698371|2947250|Equivalence|An alpha value of 0.05 was considered||||||0.18||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.|
1604898|NCT02698371|2947250|Equivalence|An alpha value of 0.05 was considered||||||0.317||||||Applied for all rows/Categories (graded on a 5-point scale) of Postoperative Hypersensibility, Tooth Vitality-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Postoperative Hypersensibility, Tooth Vitality performance at 24 month follow-up recall.|
1604899|NCT02698371|2947251|Equivalence|An alpha value of 0.05 was considered||||||0.898||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.|
1604900|NCT02698371|2947251|Equivalence|An alpha value of 0.05 was considered||||||0.071||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.|
1604901|NCT02698371|2947251|Equivalence|An alpha value of 0.05 was considered||||||0.01||||||Applied for all rows/Categories (graded on a 5-point scale) of Marginal Adaptation-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Marginal Adaptation performance at 24 month follow-up recall.|
1604902|NCT02698371|2947252|Equivalence|An alpha value of 0.05 was considered||||||0.054||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.|
1604903|NCT02698371|2947252|Equivalence|An alpha value of 0.05 was considered||||||0.02||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.|
1604904|NCT02698371|2947252|Equivalence|An alpha value of 0.05 was considered||||||0.006||||||Applied for all rows/Categories (graded on a 5-point scale) of Fractures and Retention-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Fractures and Retention performance at 24 month follow-up recall.|
1604905|NCT02698371|2947253|Equivalence|An alpha value of 0.05 was considered||||||0.064||||||Applied for all rows/Categories (graded on a 5-point scale) of Colour Stability-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.|
1604906|NCT02698371|2947253|Equivalence|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for all rows/Categories (graded on a 5-point scale) of Colour Stability-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.|
1604907|NCT02698371|2947253|Equivalence|An alpha value of 0.05 was considered|||||<|0.001||||||Applied for all rows/Categories (graded on a 5-point scale) Colour Stability-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Colour Stability performance at 24 month follow-up recall.|
1604908|NCT02698371|2947254|Equivalence|An alpha value of 0.05 was considered||||||0.829||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Staining Margin performance at 24 month follow-up recall.|
1604909|NCT02698371|2947254|Equivalence|An alpha value of 0.05 was considered||||||0.059||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Staining Margin Performance at 24 Month Follow-up recall.|
1604910|NCT02698371|2947254|Equivalence|An alpha value of 0.05 was considered||||||0.009||||||Applied for all rows/Categories (graded on a 5-point scale) Staining Margin-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 - Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Staining Margin Performance at 24 Month Follow-up recall.|
1606397|NCT02651688|2950570|Superiority|||||||0.5095|||||||Wilcoxon rank-sum test||||
1604911|NCT02698371|2947255|Equivalence|alpha value of 0.05 was considered||||||0.618||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G1G2 and G3G4 and G5G6 Arms performance from baseline to 24 month recall. P-value adjusted.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) Surface Luster performance at 24 Month Follow-up recall.|
1604912|NCT02698371|2947255|Equivalence|alpha value of 0.05 was considered||||||0.002||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G2 and G3G5 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) Surface Luster performance at 24 Month Follow-up recall;|
1604913|NCT02698371|2947255|Equivalence|alpha value of 0.05 was considered||||||0.029||||||Applied for all rows/Categories (graded on a 5-point scale) Surface Luster-FDI comparison between G1 and G4G6 Arms performance from baseline to 24 month recall.|Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) Surface Luster Performance at 24 Month Follow-up recall.|
1604914|NCT02698371|2947256|Equivalence|An alpha value of 0.05 was considered||||||0.998||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Biologic FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Biological outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.|
1604915|NCT02698371|2947256|Equivalence|An alpha value of 0.05 was considered||||||1||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Functional of FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Functional outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.|
1604916|NCT02698371|2947256|Equivalence|An alpha value of 0.05 was considered||||||1||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Esthetic of FDI and of USPHS comparison; Applied to G1G2; G3G4 and G5G6 separately.|Chi-squared|||H0: FDI or USPHS criteria Esthetic outcomes not differ at 24th month follow-up regarding Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) adhesive, with SE or SE-ER/ER modes.|
1604917|NCT02698371|2947257|Equivalence|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restoration retention rates;|
1604918|NCT02698371|2947257|Equivalence|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restorations (aesthetic, functional and biologic) success rates;|
1604919|NCT02698371|2947257|Equivalence|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;|
1604920|NCT02698371|2947257|Equivalence|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restoration retention rates;|
1604921|NCT02698371|2947257|Equivalence|alpha value of 0.05 was considered||||||0.154|||||||Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restorations (aesthetic, functional and biologic) success rates;|
1604922|NCT02698371|2947257|Equivalence|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 – Bonding to NCCLs with FBDC by SE and enamel etching mode (FBDC-SE-EE; G2) and MM adhesives by Etch-and-Rinse mode (MM-ER; G3G5) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;|
1604923|NCT02698371|2947257|Equivalence|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC-SE (G1) and MM-SE (G4G6) adhesives result in similar restoration retention rates;|
1604924|NCT02698371|2947257|Equivalence|alpha value of 0.05 was considered||||||0.189|||||||Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC-SE (G1) and MM-SE(G4G6) result in similar restorations (aesthetic, functional and biologic) success rates;|
1604925|NCT02698371|2947257|Equivalence|alpha value of 0.05 was considered||||||0.025|||||||McNemar|||H0 – Bonding to NCCLs with FBDC by Self-Etch mode (FBDC-SE; G1) and MM adhesives by SE mode (MM-SE; G4G6) result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;|
1604926|NCT02698371|2947258|Equivalence|alpha value of 0.05 was considered||||||0.07||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Retention-FDI comparison between G1G2 and G3G4 and G5G6 Arms retention rate from baseline to 24 month recall. Adjusted P-values.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restoration retention rates;|
1604927|NCT02698371|2947258|Equivalence|alpha value of 0.05 was considered||||||0.07||||||Applied for rows/Categories- Acceptance Vs Not Acceptance Functional-FDI comparison between G1G2 and G3G4 and G5G6 Arms success rate from baseline to 24 month recall. For Esthetic and Biological-FDI comparison p values were > 0.05. Adjusted P-values.|Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4) and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar restorations (aesthetic, functional and biologic) success rates;|
1604928|NCT02698371|2947258|Equivalence|alpha value of 0.05 was considered||||||0.07|||||||Kruskal-Wallis|||H0 – Bonding to NCCLs with FBDC (G1G2) or FBU (G3G4), DC adhesives, and ADU (G5G6) light-curing adhesive, with SE or SE-ER/ER modes result in similar (no significant differences) clinical (aesthetic, functional and biologic) behaviour/performance;|
1604929|NCT02698371|2947258|Equivalence|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restoration retention rates;|
1604930|NCT02698371|2947258|Equivalence|alpha value of 0.05 was considered||||||0.747|||||||Wilcoxon (Mann-Whitney)|||H0 – Bonding to NCCLs with FBDC-SE-EE (G2) and MM-ER (G3G5) result in similar restorations (aesthetic, functional and biologic) success rates;|
1604937|NCT02698176|2947293|Other||Estimation of DLT Rate|0.25|||||2-Sided|80.0|0.121|0.418|||||Point estimate and 2-sided 80% Bayesian credible interval for DLT rate estimated for the total number of participants from all 3 cohorts (CRPC+NMC+TNBC) that were evaluable for DLT analysis based on a non-informative prior distribution of Beta (1,1).||
1604938|NCT02697773|2947313|Superiority||LS Mean Ratio|0.94|Standard Error of the Mean|0.36||0.8725|2-Sided|95.0|0.44|2.0|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604939|NCT02697773|2947313|Superiority||LS Mean Ratio|1.24|Standard Error of the Mean|0.47||0.5796|2-Sided|95.0|0.58|2.61|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604940|NCT02697773|2947313|Superiority||LS Mean Ratio|0.77|Standard Error of the Mean|0.3||0.5032|2-Sided|95.0|0.36|1.65|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604941|NCT02697773|2947313|Superiority||LS Mean Ratio|0.85|Standard Error of the Mean|0.33||0.6821|2-Sided|95.0|0.4|1.82|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604942|NCT02697773|2947313|Superiority||LS Mean Ratio|0.81|Standard Error of the Mean|0.26||0.5062|2-Sided|95.0|0.43|1.52|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604943|NCT02697773|2947313|Superiority||LS Mean Ratio|0.91|Standard Error of the Mean|0.3||0.7837|2-Sided|95.0|0.48|1.73|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604944|NCT02697773|2947313|Superiority||LS Mean Ratio|0.66|Standard Error of the Mean|0.2||0.1752|2-Sided|95.0|0.36|1.2|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604945|NCT02697773|2947313|Superiority||LS Mean Ratio|0.93|Standard Error of the Mean|0.28||0.8065|2-Sided|95.0|0.51|1.68|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604946|NCT02697773|2947313|Superiority|Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|LS Mean Ratio|0.79|Standard Error of the Mean|0.2||0.3542|2-Sided|95.0|0.47|1.31|||Negative binomial model||||
1604947|NCT02697773|2947313|Superiority||LS Mean Ratio|0.97|Standard Error of the Mean|0.25||0.9164|2-Sided|95.0|0.58|1.62|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604948|NCT02697773|2947315|Superiority||LS Mean Ratio|0.94|Standard Error of the Mean|0.16||0.709|2-Sided|95.0|0.67|1.31|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604949|NCT02697773|2947315|Superiority||LS Mean Ratio|1.06|Standard Error of the Mean|0.18||0.7275|2-Sided|95.0|0.76|1.48|||Negative binomial model|||Week 16: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604950|NCT02697773|2947315|Superiority||LS Mean Ratio|0.77|Standard Error of the Mean|0.13||0.1387|2-Sided|95.0|0.55|1.09|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604951|NCT02697773|2947315|Superiority||LS Mean Ratio|0.91|Standard Error of the Mean|0.16||0.5681|2-Sided|95.0|0.65|1.27|||Negative binomial model|||Week 12: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604952|NCT02697773|2947315|Superiority||LS Mean Ratio|0.87|Standard Error of the Mean|0.13||0.3244|2-Sided|95.0|0.65|1.15|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604953|NCT02697773|2947315|Superiority||LS Mean Ratio|0.95|Standard Error of the Mean|0.14||0.728|2-Sided|95.0|0.71|1.27|||Negative binomial model|||Week 8: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604954|NCT02697773|2947315|Superiority||LS Mean Ratio|0.76|Standard Error of the Mean|0.11||0.0508|2-Sided|95.0|0.58|1.0|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1605199|NCT02696798|2947399|Superiority||LS Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.477||0.149|2-Sided|95.0|-1.63|0.25|||Mixed Models Analysis||||
1604955|NCT02697773|2947315|Superiority||LS Mean Ratio|0.88|Standard Error of the Mean|0.12||0.3371|2-Sided|95.0|0.67|1.15|||Negative binomial model|||Week 4: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604956|NCT02697773|2947315|Superiority|Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|LS Mean Ratio|0.82|Standard Error of the Mean|0.1||0.0942|2-Sided|95.0|0.65|1.03|||Negative binomial model||||
1604957|NCT02697773|2947315|Superiority||LS Mean Ratio|0.92|Standard Error of the Mean|0.11||0.4833|2-Sided|95.0|0.73|1.16|||Negative binomial model|||Week 2: LS Mean was ratio of treatments. Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, and treatment group.|
1604958|NCT02697773|2947317|Superiority||Odds Ratio (OR)|0.92||||0.6564|2-Sided|95.0|0.63|1.33|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604959|NCT02697773|2947317|Superiority||Odds Ratio (OR)|1.06||||0.7475|2-Sided|95.0|0.73|1.54|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604960|NCT02697773|2947317|Superiority||Odds Ratio (OR)|0.77||||0.1712|2-Sided|95.0|0.53|1.12|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604961|NCT02697773|2947317|Superiority||Odds Ratio (OR)|0.89||||0.5311|2-Sided|95.0|0.61|1.29|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604962|NCT02697773|2947317|Superiority||Odds Ratio (OR)|0.99||||0.972|2-Sided|95.0|0.69|1.43|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604963|NCT02697773|2947317|Superiority||Odds Ratio (OR)|0.92||||0.6706|2-Sided|95.0|0.64|1.33|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604964|NCT02697773|2947317|Superiority||Odds Ratio (OR)|0.54||||0.0013|2-Sided|95.0|0.37|0.79|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604965|NCT02697773|2947317|Superiority||Odds Ratio (OR)|0.65||||0.0262|2-Sided|95.0|0.45|0.95|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604966|NCT02697773|2947317|Superiority||Odds Ratio (OR)|0.65||||0.0312|2-Sided|95.0|0.44|0.96|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604967|NCT02697773|2947317|Superiority||Odds Ratio (OR)|0.7||||0.0761|2-Sided|95.0|0.48|1.04|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604968|NCT02697773|2947318|Superiority|||||||0.0239||||||P-value was based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.|
1604969|NCT02697773|2947318|Superiority|||||||0.0809||||||P-value was based on the log-rank test.|Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.|
1604970|NCT02697773|2947319|Superiority||Odds Ratio (OR)|0.29||||0.0335|2-Sided|95.0|0.09|0.91|||Regression, Logistic|||Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604971|NCT02697773|2947319|Superiority||Odds Ratio (OR)|0.48||||0.1444|2-Sided|95.0|0.18|1.29|||Regression, Logistic|||Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604972|NCT02697773|2947330|Superiority||Least Square Mean Difference|-3.77|Standard Error of the Mean|2.41||0.1195|2-Sided|95.0|-8.51|0.98|||ANCOVA|||Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604973|NCT02697773|2947330|Superiority||Least Square Mean Difference|-3.82|Standard Error of the Mean|2.42||0.1151|2-Sided|95.0|-8.58|0.94|||ANCOVA|||Percent Activity Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1605200|NCT02696798|2947399|Superiority||LS Mean Difference (Final Values)|-1.03|Standard Error of the Mean|0.46||0.026|2-Sided|95.0|-1.94|-0.13|||Mixed Models Analysis||||
1606398|NCT02651688|2950571|Superiority|||||||0.7509|||||||Wilcoxon rank-sum test||||
1604974|NCT02697773|2947330|Superiority||Least Square Mean Difference|-6.39|Standard Error of the Mean|4.29||0.138|2-Sided|95.0|-14.85|2.07|||ANCOVA|||Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604975|NCT02697773|2947330|Superiority||Least Square Mean Difference|-5.8|Standard Error of the Mean|4.21||0.1707|2-Sided|95.0|-14.12|2.52|||ANCOVA|||Percent Overall Work Impairment: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604976|NCT02697773|2947330|Superiority||Least Square Mean Difference|-5.59|Standard Error of the Mean|4.2||0.1857|2-Sided|95.0|-13.89|2.71|||ANCOVA|||Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604977|NCT02697773|2947330|Superiority||Least Square Mean Difference|-5.43|Standard Error of the Mean|4.14||0.1911|2-Sided|95.0|-13.59|2.74|||ANCOVA|||Percent Impairment While Working: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604978|NCT02697773|2947330|Superiority||Least Square Mean Difference|-1.68|Standard Error of the Mean|1.6||0.2953|2-Sided|95.0|-4.84|1.48|||ANCOVA|||Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604979|NCT02697773|2947330|Superiority||Least Square Mean Difference|0.61|Standard Error of the Mean|1.56||0.6984|2-Sided|95.0|-2.48|3.7|||ANCOVA|||Percent Work Time Missed: WPAI parameters were analyzed using ANCOVA model which included covariates of the corresponding baseline score, baseline diary average pain, index joint, highest Kellgren-Lawrence grade (2, 3 or 4), and treatment, with study site as a random effect.|
1604980|NCT02697773|2947333|Superiority||Least Square Mean Difference|-0.89|Standard Error of the Mean|0.25||0.0005|2-Sided|95.0|-1.39|-0.39|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604981|NCT02697773|2947333|Superiority||Least Square Mean Difference|-0.7|Standard Error of the Mean|0.25||0.0059|2-Sided|95.0|-1.2|-0.2|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604982|NCT02697773|2947333|Superiority||Least Square Mean Difference|-0.97|Standard Error of the Mean|0.26||0.0002|2-Sided|95.0|-1.48|-0.46|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604983|NCT02697773|2947333|Superiority||Least Square Mean Difference|-0.85|Standard Error of the Mean|0.26||0.0011|2-Sided|95.0|-1.36|-0.34|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604984|NCT02697773|2947333|Superiority||Least Square Mean Difference|-0.44|Standard Error of the Mean|0.24||0.0668|2-Sided|95.0|-0.92|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604985|NCT02697773|2947333|Superiority||Least Square Mean Difference|-0.63|Standard Error of the Mean|0.24||0.0091|2-Sided|95.0|-1.11|-0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604986|NCT02697773|2947333|Superiority||Least Square Mean Difference|-1.1|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.56|-0.64|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604987|NCT02697773|2947333|Superiority||Least Square Mean Difference|-0.98|Standard Error of the Mean|0.24|<|0.0001|2-Sided|95.0|-1.44|-0.51|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1605045|NCT02697773|2947342|Superiority||Odds Ratio (OR)|1.62||||0.0422|2-Sided|95.0|1.02|2.59|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1604988|NCT02697773|2947333|Superiority||Least Square Mean Difference|-0.86|Standard Error of the Mean|0.23|<|0.0002|2-Sided|95.0|-1.31|-0.41|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604989|NCT02697773|2947333|Superiority||Least Square Mean Difference|-0.64|Standard Error of the Mean|0.23|<|0.0058|2-Sided|95.0|-1.09|-0.18|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1604990|NCT02697773|2947335|Superiority||Least Square Mean Difference|-0.68|Standard Error of the Mean|0.25||0.0073|2-Sided|95.0|-1.17|-0.18|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604991|NCT02697773|2947335|Superiority||Least Square Mean Difference|-0.6|Standard Error of the Mean|0.25||0.0167|2-Sided|95.0|-1.09|-0.11|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604992|NCT02697773|2947335|Superiority||Least Square Mean Difference|-0.83|Standard Error of the Mean|0.25||0.0008|2-Sided|95.0|-1.32|-0.35|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604993|NCT02697773|2947335|Superiority||Least Square Mean Difference|-0.76|Standard Error of the Mean|0.25||0.0021|2-Sided|95.0|-1.25|-0.28|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604994|NCT02697773|2947335|Superiority||Least Square Mean Difference|-0.34|Standard Error of the Mean|0.23||0.1506|2-Sided|95.0|-0.79|0.12|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604995|NCT02697773|2947335|Superiority||Least Square Mean Difference|-0.64|Standard Error of the Mean|0.24||0.0066|2-Sided|95.0|-1.11|-0.18|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604996|NCT02697773|2947335|Superiority||Least Square Mean Difference|-0.91|Standard Error of the Mean|0.22|<|0.0001|2-Sided|95.0|-1.35|-0.47|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604997|NCT02697773|2947335|Superiority||Least Square Mean Difference|-0.85|Standard Error of the Mean|0.23|<|0.0002|2-Sided|95.0|-1.29|-0.4|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604998|NCT02697773|2947335|Superiority||Least Mean Square Difference|-0.67|Standard Error of the Mean|0.22|<|0.0023|2-Sided|95.0|-1.1|-0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1604999|NCT02697773|2947335|Superiority||Least Square Mean Difference|-0.66|Standard Error of the Mean|0.22|<|0.0026|2-Sided|95.0|-1.1|-0.23|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects,baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1605000|NCT02697773|2947337|Superiority||Least Square Mean Difference|-0.87|Standard Error of the Mean|0.24||0.0003|2-Sided|95.0|-1.33|-0.4|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1605183|NCT02696798|2947391|Superiority||LS Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.62||0.86|2-Sided|95.0|-1.1|1.3|||Mixed Models Analysis||||
1606399|NCT02651688|2950571|Superiority|||||||0.9302|||||||Wilcoxon rank-sum test||||
1605001|NCT02697773|2947337|Superiority||Least Square Mean Difference|-0.7|Standard Error of the Mean|0.24||0.0034|2-Sided|95.0|-1.16|-0.23|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1605002|NCT02697773|2947337|Superiority||Least Square Mean Difference|-1.04|Standard Error of the Mean|0.24|<|0.0001|2-Sided|95.0|-1.5|-0.57|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1605003|NCT02697773|2947337|Superiority||Least Square Mean Difference|-0.89|Standard Error of the Mean|0.24|<|0.0002|2-Sided|95.0|-1.35|-0.43|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1605004|NCT02697773|2947337|Superiority||Least Square Mean Difference|-0.59|Standard Error of the Mean|0.22|<|0.0078|2-Sided|95.0|-1.03|-0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1605005|NCT02697773|2947337|Superiority||Least Square Mean Difference|-0.68|Standard Error of the Mean|0.22|<|0.0024|2-Sided|95.0|-1.12|-0.24|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1605006|NCT02697773|2947337|Superiority||Least Square Mean Difference|-1.07|Standard Error of the Mean|0.21|<|0.0001|2-Sided|95.0|-1.49|-0.66|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1605007|NCT02697773|2947337|Superiority||Least Square Mean Difference|-1.05|Standard Error of the Mean|0.21|<|0.0001|2-Sided|95.0|-1.46|-0.63|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1605008|NCT02697773|2947337|Superiority||Least Square Mean Difference|-0.88|Standard Error of the Mean|0.21|<|0.0001|2-Sided|95.0|-1.29|-0.48|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1605009|NCT02697773|2947337|Superiority||Least Square Mean Difference|-0.82|Standard Error of the Mean|0.21|<|0.0001|2-Sided|95.0|-1.22|-0.41|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1605010|NCT02697773|2947339|Superiority||Least Square Mean Difference|-1.0|Standard Error of the Mean|0.25|<|0.0001|2-Sided|95.0|-1.48|-0.51|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1605011|NCT02697773|2947339|Superiority||Least Square Mean Difference|-0.84|Standard Error of the Mean|0.25|<|0.0007|2-Sided|95.0|-1.32|-0.35|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1605012|NCT02697773|2947339|Superiority||Least Square Mean Difference|-1.2|Standard Error of the Mean|0.24|<|0.0001|2-Sided|95.0|-1.67|-0.73|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1605013|NCT02697773|2947339|Superiority||Least Square Mean Difference|-1.03|Standard Error of the Mean|0.24|<|0.0001|2-Sided|95.0|-1.51|-0.55|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1605014|NCT02697773|2947339|Superiority||Least Square Mean Difference|-0.74|Standard Error of the Mean|0.23|<|0.0013|2-Sided|95.0|-1.2|-0.29|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1605015|NCT02697773|2947339|Superiority||Least Square Mean Difference|-0.79|Standard Error of the Mean|0.23|<|0.0007|2-Sided|95.0|-1.25|-0.33|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1605016|NCT02697773|2947339|Superiority||Least Square Mean Difference|-1.23|Standard Error of the Mean|0.22|<|0.0001|2-Sided|95.0|-1.66|-0.8|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1605017|NCT02697773|2947339|Superiority||Least Square Mean Difference|-1.24|Standard Error of the Mean|0.22|<|0.0001|2-Sided|95.0|-1.67|-0.81|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1605018|NCT02697773|2947339|Superiority||Least Mean Square Difference|-1.05|Standard Error of the Mean|0.22|<|0.0001|2-Sided|95.0|-1.47|-0.62|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1605019|NCT02697773|2947339|Superiority||Least Square Mean Difference|-1.04|Standard Error of the Mean|0.22|<|0.0001|2-Sided|95.0|-1.47|-0.61|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC stiffness subscales and baseline diary average pain as covariates, and study site as a random effect.|
1605020|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.82|Standard Error of the Mean|0.24||0.0008|2-Sided|95.0|-1.3|-0.34|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605021|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.67|Standard Error of the Mean|0.25||0.0063|2-Sided|95.0|-1.16|-0.19|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605022|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.75|Standard Error of the Mean|0.24||0.0015|2-Sided|95.0|-1.22|-0.29|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605023|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.73|Standard Error of the Mean|0.24||0.0024|2-Sided|95.0|-1.19|-0.26|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605024|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.67|Standard Error of the Mean|0.23||0.0041|2-Sided|95.0|-1.13|-0.21|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605025|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.68|Standard Error of the Mean|0.24||0.0043|2-Sided|95.0|-1.14|-0.21|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605026|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.41|Standard Error of the Mean|0.22||0.0693|2-Sided|95.0|-0.85|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605027|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.44|Standard Error of the Mean|0.23||0.0512|2-Sided|95.0|-0.89|0.0|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605028|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.68|Standard Error of the Mean|0.22||0.0023|2-Sided|95.0|-1.12|-0.24|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605184|NCT02696798|2947391|Superiority||LS Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.59||0.504|2-Sided|95.0|-1.6|0.8|||Mixed Models Analysis||||
1606400|NCT02651688|2950572|Superiority|||||||0.4529|||||||Wilcoxon rank-sum test||||
1605029|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.72|Standard Error of the Mean|0.23||0.0015|2-Sided|95.0|-1.16|-0.28|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605030|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.94|Standard Error of the Mean|0.21|<|0.0001|2-Sided|95.0|-1.36|-0.52|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605031|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.91|Standard Error of the Mean|0.22|<|0.0001|2-Sided|95.0|-1.33|-0.49|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605032|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.77|Standard Error of the Mean|0.21|<|0.0002|2-Sided|95.0|-1.17|-0.36|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605033|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.67|Standard Error of the Mean|0.21|<|0.0014|2-Sided|95.0|-1.08|-0.26|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605034|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.55|Standard Error of the Mean|0.2|<|0.0053|2-Sided|95.0|-0.93|-0.16|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605035|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.64|Standard Error of the Mean|0.2|<|0.0011|2-Sided|95.0|-1.03|-0.25|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605036|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.38|Standard Error of the Mean|0.15|<|0.0139|2-Sided|95.0|-0.68|-0.08|||ANCOVA|||Week 1:Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605037|NCT02697773|2947341|Superiority||Least Square Mean Difference|-0.33|Standard Error of the Mean|0.15|<|0.0319|2-Sided|95.0|-0.63|-0.03|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets includes treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline diary average pain as covariate, and study site as a random effect.|
1605038|NCT02697773|2947342|Superiority||Odds Ratio (OR)|1.49||||0.0846|2-Sided|95.0|0.95|2.35|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605039|NCT02697773|2947342|Superiority||Odds Ratio (OR)|1.66||||0.0307|2-Sided|95.0|1.05|2.62|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605040|NCT02697773|2947342|Superiority||Odds Ratio (OR)|1.72||||0.0124|2-Sided|95.0|1.12|2.63|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605041|NCT02697773|2947342|Superiority||Odds Ratio (OR)|1.55||||0.0476|2-Sided|95.0|1.0|2.39|||Regression, Logistic|||Week 12: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605042|NCT02697773|2947342|Superiority||Odds Ratio (OR)|1.06||||0.7856|2-Sided|95.0|0.68|1.67|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605043|NCT02697773|2947342|Superiority||Odds Ratio (OR)|1.17||||0.4878|2-Sided|95.0|0.75|1.84|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605044|NCT02697773|2947342|Superiority||Odds Ratio (OR)|1.36||||0.1995|2-Sided|95.0|0.85|2.16|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605185|NCT02696798|2947392|Superiority||LS Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.59||0.626|2-Sided|95.0|-1.4|0.9|||Mixed Models Analysis||||
1605046|NCT02697773|2947342|Superiority||Odds Ratio (OR)|0.99||||0.9644|2-Sided|95.0|0.6|1.62|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605047|NCT02697773|2947342|Superiority||Odds Ratio (OR)|1.44||||0.1463|2-Sided|95.0|0.88|2.34|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline PGA of osteoarthritis, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605048|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.3|||<|0.0001|2-Sided|95.0|1.57|3.36|||Regression, Logistic|||Week 16, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605049|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.47|||<|0.1808|2-Sided|95.0|0.84|2.57|||Regression, Logistic|||Week 16, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605050|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.42|||<|0.2286|2-Sided|95.0|0.8|2.5|||Regression, Logistic|||Week 16, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605051|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.9|||<|0.0022|2-Sided|95.0|1.26|2.87|||Regression, Logistic|||Week 16, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605052|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.69|||<|0.0141|2-Sided|95.0|1.11|2.56|||Regression, Logistic|||Week 16, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605053|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.96|||<|0.0005|2-Sided|95.0|1.34|2.87|||Regression, Logistic|||Week 16 >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605054|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.12|||<|0.0002|2-Sided|95.0|1.43|3.14|||Regression, Logistic|||Week 16 >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605055|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.58|||<|0.02|2-Sided|95.0|1.07|2.31|||Regression, Logistic|||Week 16 >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605056|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.19|||<|0.0064|2-Sided|95.0|1.25|3.85|||Regression, Logistic|||Week 12, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605057|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.09|||<|0.0113|2-Sided|95.0|1.18|3.68|||Regression, Logistic|||Week 12, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605058|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.29|||<|0.0001|2-Sided|95.0|1.52|3.46|||Regression, Logistic|||Week 12, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605059|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.13|||<|0.0003|2-Sided|95.0|1.41|3.23|||Regression, Logistic|||Week 12, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605060|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.08|||<|0.0002|2-Sided|95.0|1.42|3.04|||Regression, Logistic|||Week 12, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605061|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.11|||<|0.0001|2-Sided|95.0|1.44|3.09|||Regression, Logistic|||Week 12, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605062|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.64|||<|0.0001|2-Sided|95.0|1.78|3.93|||Regression, Logistic|||Week 12, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605063|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.01|||<|0.0004|2-Sided|95.0|1.36|2.96|||Regression, Logistic|||Week 12, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605186|NCT02696798|2947392|Superiority||LS Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.58||0.861|2-Sided|95.0|-1.0|1.3|||Mixed Models Analysis||||
1605064|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.76|||<|0.0718|2-Sided|95.0|0.95|3.27|||Regression, Logistic|||Week 8, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605065|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.74|||<|0.0796|2-Sided|95.0|0.94|3.23|||Regression, Logistic|||Week 8, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605066|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.87|||<|0.0065|2-Sided|95.0|1.19|2.94|||Regression, Logistic|||Week 8, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605067|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.74|||<|0.0175|2-Sided|95.0|1.1|2.74|||Regression, Logistic|||Week 8, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605068|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.77|||<|0.004|2-Sided|95.0|1.2|2.62|||Regression, Logistic|||Week 8, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605069|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.12|||<|0.0002|2-Sided|95.0|1.43|3.13|||Regression, Logistic|||Week 8, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605070|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.73|||<|0.0039|2-Sided|95.0|1.19|2.51|||Regression, Logistic|||Week 8, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605071|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.49|||<|0.036|2-Sided|95.0|1.03|2.16|||Regression, Logistic|||Week 8, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605072|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.31|||<|0.0088|2-Sided|95.0|1.24|4.34|||Regression, Logistic|||Week 4, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605073|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.02|||<|0.031|2-Sided|95.0|1.07|3.82|||Regression, Logistic|||Week 4, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605074|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.45|||<|0.0001|2-Sided|95.0|1.55|3.89|||Regression, Logistic|||Week 4, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605075|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.33|||<|0.0003|2-Sided|95.0|1.47|3.7|||Regression, Logistic|||Week 4, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605076|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.57|||<|0.0001|2-Sided|95.0|1.74|3.82|||Regression, Logistic|||Week 4, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605077|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.41|||<|0.0001|2-Sided|95.0|1.62|3.57|||Regression, Logistic|||Week 4, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605078|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.12|||<|0.0001|2-Sided|95.0|1.46|3.09|||Regression, Logistic|||Week 4, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605079|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.3|||<|0.0001|2-Sided|95.0|1.58|3.36|||Regression, Logistic|||Week 4, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605080|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.76|||<|0.1348|2-Sided|95.0|0.84|3.69|||Regression, Logistic|||Week 2, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605081|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.1|||<|0.0436|2-Sided|95.0|1.02|4.32|||Regression, Logistic|||Week 2, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1606401|NCT02651688|2950572|Superiority|||||||0.7103|||||||Wilcoxon rank-sum test||||
1605082|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.39|||<|0.0006|2-Sided|95.0|1.45|3.94|||Regression, Logistic|||Week 2, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605083|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.44|||<|0.0005|2-Sided|95.0|1.48|4.01|||Regression, Logistic|||Week 2, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605084|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.12|||<|0.0003|2-Sided|95.0|1.4|3.19|||Regression, Logistic|||Week 2, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605085|NCT02697773|2947344|Superiority||Odds Ratio (OR)|1.58|||<|0.0312|2-Sided|95.0|1.04|2.39|||Regression, Logistic|||Week 2, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605086|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.32|||<|0.0001|2-Sided|95.0|1.59|3.4|||Regression, Logistic|||Week 2, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605087|NCT02697773|2947344|Superiority||Odds Ratio (OR)|2.12|||<|0.0001|2-Sided|95.0|1.45|3.11|||Regression, Logistic|||Week 2, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC physical function subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605088|NCT02697773|2947346|Superiority|The two comparisons for 'Participants with ≥50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus placebo and tanezumab 2.5/5 mg treatment group versus placebo) were adjusted for multiple comparisons using the Hochberg procedure and an overall significance level of 0.05.|Odds Ratio (OR)|2.17|||<|0.0001|2-Sided|95.0|1.48|3.16|||Regression, Logistic|||Week 16 >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605089|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.56|||<|0.1351|2-Sided|95.0|0.87|2.79|||Regression, Logistic|||Week 16, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605090|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.6|||<|0.1149|2-Sided|95.0|0.89|2.86|||Regression, Logistic|||Week 16, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605091|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.72|||<|0.009|2-Sided|95.0|1.14|2.57|||Regression, Logistic|||Week 16, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605092|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.53|||<|0.0411|2-Sided|95.0|1.02|2.31|||Regression, Logistic|||Week 16, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605093|NCT02697773|2947346|Superiority|The two comparisons for 'Participants with >=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus placebo and tanezumab 2.5/5 mg treatment group versus placebo) were adjusted for multiple comparisons using the Hochberg procedure and an overall significance level of 0.05.|Odds Ratio (OR)|1.89|||<|0.001|2-Sided|95.0|1.29|2.76|||Regression, Logistic|||Week 16 >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605094|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.95|||<|0.0007|2-Sided|95.0|1.33|2.88|||Regression, Logistic|||Week 16 >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605095|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.72|||<|0.0061|2-Sided|95.0|1.17|2.52|||Regression, Logistic|||Week 16 >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605096|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.11|||<|0.0075|2-Sided|95.0|1.22|3.64|||Regression, Logistic|||Week 12, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605097|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.01|||<|0.0127|2-Sided|95.0|1.16|3.49|||Regression, Logistic|||Week 12, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605098|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.05|||<|0.0005|2-Sided|95.0|1.37|3.06|||Regression, Logistic|||Week 12, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1607167|NCT02634073|2952054|Superiority or Other||Ratio|0.636|||||2-Sided|90.0|0.595|0.68|||||AUC (0-t) comparision||
1605099|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.0|||<|0.0008|2-Sided|95.0|1.33|2.99|||Regression, Logistic|||Week 12, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605100|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.84|||<|0.0014|2-Sided|95.0|1.26|2.67|||Regression, Logistic|||Week 12, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605101|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.12|||<|0.0001|2-Sided|95.0|1.45|3.1|||Regression, Logistic|||Week 12, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605102|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.5|||<|0.0001|2-Sided|95.0|1.68|3.73|||Regression, Logistic|||Week 12, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605103|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.89|||<|0.0013|2-Sided|95.0|1.28|2.79|||Regression, Logistic|||Week 12, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605104|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.48|||<|0.1923|2-Sided|95.0|0.82|2.68|||Regression, Logistic|||Week 8, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605105|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.48|||<|0.2005|2-Sided|95.0|0.81|2.67|||Regression, Logistic|||Week 8, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605106|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.64|||<|0.0322|2-Sided|95.0|1.04|2.58|||Regression, Logistic|||Week 8, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605107|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.0|||<|0.0023|2-Sided|95.0|1.28|3.12|||Regression, Logistic|||Week 8, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605108|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.66|||<|0.01|2-Sided|95.0|1.13|2.45|||Regression, Logistic|||Week 8, >=50%:Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605109|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.99|||<|0.0005|2-Sided|95.0|1.35|2.92|||Regression, Logistic|||Week 8, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605110|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.6|||<|0.0132|2-Sided|95.0|1.1|2.32|||Regression, Logistic|||Week 8, >=30%:Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605111|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.62|||<|0.0118|2-Sided|95.0|1.11|2.35|||Regression, Logistic|||Week 8, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605112|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.06|||<|0.0173|2-Sided|95.0|1.14|3.72|||Regression, Logistic|||Week 4, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605113|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.06|||<|0.0172|2-Sided|95.0|1.14|3.72|||Regression, Logistic|||Week 4, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605114|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.13|||<|0.0011|2-Sided|95.0|1.35|3.34|||Regression, Logistic|||Week 4, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605115|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.02|||<|0.0024|2-Sided|95.0|1.28|3.18|||Regression, Logistic|||Week 4, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605116|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.15|||<|0.0001|2-Sided|95.0|1.46|3.15|||Regression, Logistic|||Week 4, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605117|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.07|||<|0.0002|2-Sided|95.0|1.41|3.05|||Regression, Logistic|||Week 4, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605118|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.92|||<|0.0006|2-Sided|95.0|1.32|2.79|||Regression, Logistic|||Week 4, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605119|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.07|||<|0.0002|2-Sided|95.0|1.42|3.02|||Regression, Logistic|||Week 4, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605120|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.38|||<|0.3486|2-Sided|95.0|0.7|2.72|||Regression, Logistic|||Week 2, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605121|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.95|||<|0.0404|2-Sided|95.0|1.03|3.71|||Regression, Logistic|||Week 2, >=90%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605122|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.7|||<|0.0276|2-Sided|95.0|1.06|2.72|||Regression, Logistic|||Week 2, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605123|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.72|||<|0.0251|2-Sided|95.0|1.07|2.75|||Regression, Logistic|||Week 2, >=70%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605124|NCT02697773|2947346|Superiority||Odds Ratio (OR)|2.03|||<|0.0008|2-Sided|95.0|1.34|3.07|||Regression, Logistic|||Week 2, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605125|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.95|||<|0.0015|2-Sided|95.0|1.29|2.96|||Regression, Logistic|||Week 2, >=50%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605126|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.99|||<|0.0004|2-Sided|95.0|1.36|2.9|||Regression, Logistic|||Week 2, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605127|NCT02697773|2947346|Superiority||Odds Ratio (OR)|1.9|||<|0.0009|2-Sided|95.0|1.3|2.78|||Regression, Logistic|||Week 2, >=30%: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605128|NCT02697773|2947347|Superiority||Odds Ratio (OR)|1.99||||0.0014|2-Sided|95.0|1.31|3.04|||Regression, Logistic|||Week 16: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605129|NCT02697773|2947347|Superiority||Odds Ratio (OR)|1.39||||0.1139|2-Sided|95.0|0.92|2.07|||Regression, Logistic|||Week 16: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605130|NCT02697773|2947347|Superiority||Odds Ratio (OR)|2.13||||0.0006|2-Sided|95.0|1.38|3.27|||Regression, Logistic|||Week 12: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605131|NCT02697773|2947347|Superiority||Odds Ratio (OR)|1.68||||0.0154|2-Sided|95.0|1.1|2.54|||Regression, Logistic|||Week 12: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605132|NCT02697773|2947347|Superiority||Odds Ratio (OR)|1.38||||0.1066|2-Sided|95.0|0.93|2.03|||Regression, Logistic|||Week 8: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605133|NCT02697773|2947347|Superiority||Odds Ratio (OR)|1.27||||0.2283|2-Sided|95.0|0.86|1.87|||Regression, Logistic|||Week 8: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605134|NCT02697773|2947347|Superiority||Odds Ratio (OR)|2.04||||0.0004|2-Sided|95.0|1.37|3.04|||Regression, Logistic|||Week 4: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605135|NCT02697773|2947347|Superiority||Odds Ratio (OR)|1.98||||0.0008|2-Sided|95.0|1.33|2.95|||Regression, Logistic|||Week 4: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605187|NCT02696798|2947393|Superiority||LS Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.538||0.064|2-Sided|95.0|-2.06|0.06|||Mixed Models Analysis||||
1607414|NCT02628028|2952543|Superiority|||||||0.823|||||||Regression, Logistic||||
1605136|NCT02697773|2947347|Superiority||Odds Ratio (OR)|1.98||||0.0004|2-Sided|95.0|1.36|2.89|||Regression, Logistic|||Week 2: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605137|NCT02697773|2947347|Superiority||Odds Ratio (OR)|1.78||||0.0027|2-Sided|95.0|1.22|2.61|||Regression, Logistic|||Week 2: Odds ratio and 95% confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade and treatment.|
1605138|NCT02697773|2947349|Superiority||Least Square Mean Difference|-0.28|Standard Error of the Mean|0.09||0.0014|2-Sided|95.0|-0.45|-0.11|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.|
1605139|NCT02697773|2947349|Superiority||Least Square Mean Difference|-0.17|Standard Error of the Mean|0.09||0.0426|2-Sided|95.0|-0.34|-0.01|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.|
1605140|NCT02697773|2947349|Superiority||Least Square Mean Difference|-0.09|Standard Error of the Mean|0.08||0.238|2-Sided|95.0|-0.24|0.06|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.|
1605141|NCT02697773|2947349|Superiority||Least Square Mean Difference|-0.15|Standard Error of the Mean|0.08||0.0498|2-Sided|95.0|-0.31|0.0|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.|
1605142|NCT02697773|2947349|Superiority||Least Mean Square Difference|-0.21|Standard Error of the Mean|0.07||0.004|2-Sided|95.0|-0.36|-0.07|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.|
1605143|NCT02697773|2947349|Superiority||Least Square Mean Difference|-0.26|Standard Error of the Mean|0.07||0.0007|2-Sided|95.0|-0.4|-0.11|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.|
1605144|NCT02697773|2947349|Superiority||Least Square Mean Difference|-0.12|Standard Error of the Mean|0.07||0.0958|2-Sided|95.0|-0.27|0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605145|NCT02697773|2947349|Superiority||Least Mean Square Difference|-0.17|Standard Error of the Mean|0.07||0.0236|2-Sided|95.0|-0.32|-0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariate, and study site as a random effect.|
1605146|NCT02697773|2947351|Superiority||Least Square Mean Difference|-1.05|Standard Error of the Mean|0.24|<|0.0001|2-Sided|95.0|-1.52|-0.58|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605147|NCT02697773|2947351|Superiority||Least Square Mean Difference|-0.86|Standard Error of the Mean|0.24|<|0.0004|2-Sided|95.0|-1.33|-0.38|||ANCOVA|||Week 12:Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605148|NCT02697773|2947351|Superiority||Least Square Mean Difference|-0.57|Standard Error of the Mean|0.23|<|0.0114|2-Sided|95.0|-1.02|-0.13|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605149|NCT02697773|2947351|Superiority||Least Square Mean Difference|-0.63|Standard Error of the Mean|0.23|<|0.0057|2-Sided|95.0|-1.07|-0.18|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605188|NCT02696798|2947393|Superiority||LS Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.521||0.547|2-Sided|95.0|-1.34|0.71|||Mixed Models Analysis||||
1605150|NCT02697773|2947351|Superiority||Least Square Mean Difference|-1.11|Standard Error of the Mean|0.22|<|0.0001|2-Sided|95.0|-1.53|-0.68|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605151|NCT02697773|2947351|Superiority||Least Square Mean Difference|-1.02|Standard Error of the Mean|0.22|<|0.0001|2-Sided|95.0|-1.45|-0.6|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605152|NCT02697773|2947351|Superiority||Least Square Mean Difference|-0.91|Standard Error of the Mean|0.21|<|0.0001|2-Sided|95.0|-1.33|-0.5|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605153|NCT02697773|2947351|Superiority||Least Mean Square Difference|-0.75|Standard Error of the Mean|0.21|<|0.0004|2-Sided|95.0|-1.17|-0.34|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605154|NCT02697773|2947353|Superiority||Least Square Mean Difference|-0.86|Standard Error of the Mean|0.24||0.0004|2-Sided|95.0|-1.33|-0.38|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605155|NCT02697773|2947353|Superiority||Least Square Mean Difference|-0.78|Standard Error of the Mean|0.24||0.0012|2-Sided|95.0|-1.25|-0.31|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605156|NCT02697773|2947353|Superiority||Least Square Mean Difference|-0.41|Standard Error of the Mean|0.22||0.0657|2-Sided|95.0|-0.85|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605157|NCT02697773|2947353|Superiority||Least Square Mean Difference|-0.59|Standard Error of the Mean|0.23||0.0085|2-Sided|95.0|-1.03|-0.15|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605158|NCT02697773|2947353|Superiority||Least Square Mean Difference|-0.87|Standard Error of the Mean|0.22|<|0.0001|2-Sided|95.0|-1.3|-0.44|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605159|NCT02697773|2947353|Superiority||Least Square Mean Difference|-0.88|Standard Error of the Mean|0.22|<|0.0001|2-Sided|95.0|-1.31|-0.45|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605160|NCT02697773|2947353|Superiority||Least Square Mean Difference|-0.68|Standard Error of the Mean|0.21|<|0.0014|2-Sided|95.0|-1.1|-0.26|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605161|NCT02697773|2947353|Superiority||Least Square Mean Difference|-0.66|Standard Error of the Mean|0.21|<|0.002|2-Sided|95.0|-1.08|-0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariate, and study site as a random effect.|
1605162|NCT02697773|2947354|Superiority|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.25|Standard Error of the Mean|0.09||0.0038|2-Sided|95.0|-0.41|-0.08||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1605244|NCT02696785|2947420|Superiority||LSMean Difference|-0.5|Standard Error of the Mean|0.48||0.317|2-Sided|95.0|-1.4|0.5|||Mixed Models Analysis||||
1605163|NCT02697773|2947354|Superiority|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.22|Standard Error of the Mean|0.09||0.0109|2-Sided|95.0|-0.39|-0.05||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline PGA of osteoarthritis and baseline diary average pain as covariates, and study site as a random effect.|
1605164|NCT02697773|2947355|Superiority|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.89|Standard Error of the Mean|0.24||0.0002|2-Sided|95.0|-1.37|-0.42||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1605165|NCT02697773|2947355|Superiority|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.66|Standard Error of the Mean|0.24||0.0065|2-Sided|95.0|-1.14|-0.19||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed data sets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1605166|NCT02697773|2947356|Superiority|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.73|Standard Error of the Mean|0.24||0.0023|2-Sided|95.0|-1.2|-0.26||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1605167|NCT02697773|2947356|Superiority|Step-down testing procedure within each of the primary endpoints was applied to maintain Type I error. Tanezumab 2.5/5 mg vs placebo was tested first and if found significant, then the testing was continued for Tanezumab 2.5 mg vs placebo. Tanezumab treatment group was declared as superior to placebo if the corresponding treatment contrast was significant over all 3 primary endpoints.|Least Square Mean Difference|-0.6|Standard Error of the Mean|0.24||0.0129|2-Sided|95.0|-1.07|-0.13||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1605168|NCT02697435|2947358|Superiority||||||<|0.05||||||P-value is calculated.|Mixed Models Analysis||||
1605169|NCT02697292|2947359|Superiority|||||||0.1|||||||Wilcoxon (Mann-Whitney)||||
1605170|NCT02697292|2947360|Superiority||Odds Ratio (OR)|10.5||||0.044|2-Sided|95.0|1.1|98.9|||t-test, 1 sided||||
1605171|NCT02696798|2947385|Superiority||LS Mean Difference (Final Values)|-8.3|Standard Error of the Mean|3.65||0.024|2-Sided|95.0|-15.5|-1.1|||ANCOVA|||Percentage of Activity Impairment|
1605172|NCT02696798|2947385|Superiority||LS Mean Difference (Final Values)|-6.3|Standard Error of the Mean|3.5||0.071|2-Sided|95.0|-13.2|0.5|||ANCOVA|||Percentage of Activity Impairment|
1605173|NCT02696798|2947385|Superiority||LS Mean Difference (Final Values)|-13.66|Standard Error of the Mean|5.341||0.012|2-Sided|95.0|-24.23|-3.1|||ANCOVA|||Overall Work Impairment Score|
1605174|NCT02696798|2947385|Superiority||LS Mean Difference (Final Values)|-11.13|Standard Error of the Mean|5.323||0.038|2-Sided|95.0|-21.65|-0.6|||ANCOVA|||Overall Work Impairment Score|
1605175|NCT02696798|2947386|Superiority||LS Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.7||0.366|2-Sided|95.0|-2.0|0.7|||Mixed Models Analysis||||
1605176|NCT02696798|2947386|Superiority||LS Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.68||0.088|2-Sided|95.0|-2.5|0.2|||Mixed Models Analysis||||
1605177|NCT02696798|2947387|Superiority||LS Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.34||0.005|2-Sided|95.0|-1.6|-0.3|||Mixed Models Analysis||||
1605178|NCT02696798|2947387|Superiority||LS Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.33|<|0.001|2-Sided|95.0|-1.9|-0.6|||Mixed Models Analysis||||
1605179|NCT02696798|2947389|Superiority||LS Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.71||0.41|2-Sided|95.0|-2.0|0.8|||Mixed Models Analysis||||
1605180|NCT02696798|2947389|Superiority||LS Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.7||0.813|2-Sided|95.0|-1.5|1.2|||Mixed Models Analysis||||
1605181|NCT02696798|2947390|Superiority||LS Mean Difference (Final Values)|-1.1|Standard Error of the Mean|1.08||0.303|2-Sided|95.0|-3.3|1.0|||Mixed Models Analysis||||
1605182|NCT02696798|2947390|Superiority||LS Mean Difference (Final Values)|-0.9|Standard Error of the Mean|1.03||0.362|2-Sided|95.0|-3.0|1.1|||Mixed Models Analysis||||
1605201|NCT02696798|2947400|Superiority||LS Mean Difference (Final Values)|4.7585|Standard Error of the Mean|1.1505|<|0.001|2-Sided|95.0|2.494|7.023|||Mixed Models Analysis|||PCS|
1605202|NCT02696798|2947400|Superiority||LS Mean Difference (Final Values)|5.2147|Standard Error of the Mean|1.1149|<|0.001|2-Sided|95.0|3.0204|7.409|||Mixed Models Analysis|||PCS|
1605203|NCT02696798|2947400|Superiority||LS Mean Difference (Final Values)|0.9104|Standard Error of the Mean|1.3338|<|0.495|2-Sided|95.0|-1.7151|3.536|||Mixed Models Analysis|||MCS|
1605204|NCT02696798|2947400|Superiority||LS Mean Difference (Final Values)|0.7689|Standard Error of the Mean|1.2863|<|0.55|2-Sided|95.0|-1.7629|3.3007|||Mixed Models Analysis|||MCS|
1605205|NCT02696798|2947401|Superiority||Odds Ratio (OR)|4.52||||0.006|2-Sided|95.0|1.55|13.18|||Regression, Logistic||||
1605206|NCT02696798|2947401|Superiority||Odds Ratio (OR)|4.22||||0.006|2-Sided|95.0|1.5|11.86|||Regression, Logistic||||
1605207|NCT02696798|2947402|Superiority||Odds Ratio (OR)|5.42||||0.127|2-Sided|95.0|0.62|47.54|||Regression, Logistic||||
1605208|NCT02696798|2947402|Superiority||Odds Ratio (OR)|3.73||||0.242|2-Sided|95.0|0.41|33.98|||Regression, Logistic||||
1605209|NCT02696798|2947403|Superiority||LS Mean Difference (Final Values)|-1.28|Standard Error of the Mean|0.307|<|0.001|2-Sided|95.0|-1.89|-0.68|||Mixed Models Analysis||||
1605210|NCT02696798|2947403|Superiority||LS Mean Difference (Final Values)|-1.05|Standard Error of the Mean|0.295|<|0.001|2-Sided|95.0|-1.63|-0.47|||Mixed Models Analysis||||
1605211|NCT02696798|2947404|Superiority||LS Mean Difference (Final Values)|-1.16|Standard Error of the Mean|0.301|<|0.001|2-Sided|95.0|-1.76|-0.57|||Mixed Models Analysis||||
1605212|NCT02696798|2947404|Superiority||LS Mean Difference (Final Values)|-1.24|Standard Error of the Mean|0.291|<|0.001|2-Sided|95.0|-1.81|-0.67|||Mixed Models Analysis||||
1605213|NCT02696798|2947405|Superiority||Odds Ratio (OR)|2.9||||0.01|2-Sided|95.0|1.29|6.49|||Regression, Logistic||||
1605214|NCT02696798|2947405|Superiority||Odds Ratio (OR)|2.65||||0.015|2-Sided|95.0|1.21|5.84|||Regression, Logistic||||
1605215|NCT02696798|2947406|Superiority||LS Mean Difference (Final Values)|-1.03|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-1.3|-0.75|||Mixed Models Analysis||||
1605216|NCT02696798|2947406|Superiority||LS Mean Difference (Final Values)|-1.05|Standard Error of the Mean|0.135|<|0.001|2-Sided|95.0|-1.32|-0.79|||Mixed Models Analysis||||
1605217|NCT02696798|2947407|Superiority||Odds Ratio (OR)|2.08||||0.013|2-Sided|95.0|1.16|3.73|||Regression, Logistic||||
1605218|NCT02696798|2947407|Superiority||Odds Ratio (OR)|2.2||||0.006|2-Sided|95.0|1.26|3.84|||Regression, Logistic||||
1605219|NCT02696798|2947408|Superiority||Odds Ratio (OR)|3.06||||0.003|2-Sided|95.0|1.48|6.33|||Regression, Logistic||||
1605220|NCT02696798|2947408|Superiority||Odds Ratio (OR)|2.41||||0.017|2-Sided|95.0|1.17|4.95|||Regression, Logistic||||
1605221|NCT02696785|2947409|Superiority||LSMean Difference|-8.08|Standard Error of the Mean|1.603|<|0.001|2-Sided|95.0|-11.2|-4.9|||ANCOVA||||
1605222|NCT02696785|2947409|Superiority||LSMean Difference|-9.51|Standard Error of the Mean|1.591|<|0.001|2-Sided|95.0|-12.6|-6.4|||ANCOVA||||
1605223|NCT02696785|2947409|Superiority||LSMean Difference|-10.07|Standard Error of the Mean|1.588|<|0.001|2-Sided|95.0|-13.2|-6.9|||ANCOVA||||
1605224|NCT02696785|2947410|Superiority||LSMean Difference|-1.0|Standard Error of the Mean|0.77||0.182|2-Sided|95.0|-2.6|0.5|||Mixed Models Analysis||||
1605225|NCT02696785|2947410|Superiority||LSMean Difference|-1.9|Standard Error of the Mean|0.73||0.011|2-Sided|95.0|-3.4|-0.4|||Mixed Models Analysis||||
1605226|NCT02696785|2947410|Superiority||LSMean Difference|-1.1|Standard Error of the Mean|0.76||0.166|2-Sided|95.0|-2.6|0.4|||Mixed Models Analysis||||
1605227|NCT02696785|2947414|Superiority||LSMean Difference|-5.47|Standard Error of the Mean|3.27||0.096|2-Sided|95.0|-11.92|0.98|||Mixed Models Analysis||||
1605228|NCT02696785|2947414|Superiority||LSMean Difference|2.5|Standard Error of the Mean|3.146||0.429|2-Sided|95.0|-3.71|8.7|||Mixed Models Analysis||||
1605229|NCT02696785|2947414|Superiority||LSMean Difference|0.04|Standard Error of the Mean|3.082||0.989|2-Sided|95.0|-6.03|6.12|||Mixed Models Analysis||||
1605230|NCT02696785|2947415|Superiority||LSMean Difference|-1.4|Standard Error of the Mean|0.58||0.013|2-Sided|95.0|-2.6|-0.3|||Mixed Models Analysis||||
1605231|NCT02696785|2947415|Superiority||LSMean Difference|-0.9|Standard Error of the Mean|0.59||0.125|2-Sided|95.0|-2.1|0.3|||Mixed Models Analysis||||
1605232|NCT02696785|2947415|Superiority||LSMean Difference|-1.2|Standard Error of the Mean|0.57||0.041|2-Sided|95.0|-2.3|0.0|||Mixed Models Analysis||||
1605233|NCT02696785|2947416|Superiority||LSMean Difference|-0.7|Standard Error of the Mean|0.33||0.035|2-Sided|95.0|-1.3|0.0|||Mixed Models Analysis||||
1605234|NCT02696785|2947416|Superiority||LSMean Difference|-1.0|Standard Error of the Mean|0.33||0.002|2-Sided|95.0|-1.7|-0.4|||Mixed Models Analysis||||
1605235|NCT02696785|2947416|Superiority||LSMean Difference|-0.7|Standard Error of the Mean|0.32||0.027|2-Sided|95.0|-1.3|-0.1|||Mixed Models Analysis||||
1605236|NCT02696785|2947418|Superiority||LSMean Difference|-1.3|Standard Error of the Mean|0.77||0.091|2-Sided|95.0|-2.8|0.2|||Mixed Models Analysis||||
1605237|NCT02696785|2947418|Superiority||LSMean Difference|-0.5|Standard Error of the Mean|0.78||0.55|2-Sided|95.0|-2.0|1.1|||Mixed Models Analysis||||
1605238|NCT02696785|2947418|Superiority||LSMean Difference|-0.2|Standard Error of the Mean|0.76||0.783|2-Sided|95.0|-1.7|1.3|||Mixed Models Analysis||||
1605239|NCT02696785|2947419|Superiority||LSMean Difference|-0.5|Standard Error of the Mean|0.58||0.398|2-Sided|95.0|-1.6|0.7|||Mixed Models Analysis||||
1605240|NCT02696785|2947419|Superiority||LSMean Difference|0.255|Standard Error of the Mean|0.56||-0.6|2-Sided|95.0|-1.8|0.5|||Mixed Models Analysis||||
1605241|NCT02696785|2947419|Superiority||LSMean Difference|-0.8|Standard Error of the Mean|0.56||0.154|2-Sided|95.0|-1.9|0.3|||Mixed Models Analysis||||
1605242|NCT02696785|2947420|Superiority||LSMean Difference|-0.3|Standard Error of the Mean|0.48||0.5|2-Sided|95.0|-1.3|0.6|||Mixed Models Analysis||||
1605243|NCT02696785|2947420|Superiority||LSMean Difference|-0.2|Standard Error of the Mean|0.48||0.683|2-Sided|95.0|-1.1|0.8|||Mixed Models Analysis||||
1605335|NCT02693132|2947566|Superiority||||||<|0.05|||||||ANOVA||||
1605245|NCT02696785|2947421|Superiority||LSMean Difference|-5.17|Standard Error of the Mean|0.816|<|0.001|2-Sided|95.0|-6.8|-3.6|||ANCOVA||||
1605246|NCT02696785|2947421|Superiority||LSMean Difference|-4.89|Standard Error of the Mean|0.812|<|0.001|2-Sided|95.0|-6.5|-3.3|||ANCOVA||||
1605247|NCT02696785|2947421|Superiority||LSMean Difference|-5.13|Standard Error of the Mean|0.806|<|0.001|2-Sided|95.0|-6.7|-3.5|||ANCOVA||||
1605248|NCT02696785|2947422|Superiority||LSMean Difference|-0.67|Standard Error of the Mean|0.327||0.042|2-Sided|95.0|-1.31|-0.03|||Mixed Models Analysis||||
1605249|NCT02696785|2947422|Superiority||LSMean Difference|-0.63|Standard Error of the Mean|0.33||0.057|2-Sided|95.0|-1.28|0.02|||Mixed Models Analysis||||
1605250|NCT02696785|2947422|Superiority||LSMean Difference|-0.67|Standard Error of the Mean|0.321||0.039|2-Sided|95.0|-1.3|-0.03|||Mixed Models Analysis||||
1605251|NCT02696785|2947423|Superiority||LSMean Difference|0.6|Standard Error of the Mean|0.215||0.005|2-Sided|95.0|0.18|1.03|||Mixed Models Analysis||||
1605252|NCT02696785|2947423|Superiority||LSMean Difference|0.43|Standard Error of the Mean|0.219||0.051|2-Sided|95.0|0.0|0.86|||Mixed Models Analysis||||
1605253|NCT02696785|2947423|Superiority||LSMean Difference|0.63|Standard Error of the Mean|0.211||0.003|2-Sided|95.0|0.22|1.05|||Mixed Models Analysis||||
1605254|NCT02696785|2947424|Superiority||LSMean Difference|-0.329|Standard Error of the Mean|0.1167||0.005|2-Sided|95.0|-0.558|-0.099|||Mixed Models Analysis||||
1605255|NCT02696785|2947424|Superiority||LSMean Difference|-0.422|Standard Error of the Mean|0.1184|<|0.001|2-Sided|95.0|-0.655|-0.189|||Mixed Models Analysis||||
1605256|NCT02696785|2947424|Superiority||LSMean Difference|-0.367|Standard Error of the Mean|0.1143|<|0.001|2-Sided|95.0|-0.592|-0.142|||Mixed Models Analysis||||
1605257|NCT02696785|2947425|Superiority||LSMean Difference|-7.991|Standard Error of the Mean|2.7248||0.004|2-Sided|95.0|-13.351|-2.631|||Mixed Models Analysis||||
1605258|NCT02696785|2947425|Superiority||LSMean Difference|-6.635|Standard Error of the Mean|2.7438||0.016|2-Sided|95.0|-12.033|-1.238|||Mixed Models Analysis||||
1605259|NCT02696785|2947425|Superiority||LSMean Difference|-8.628|Standard Error of the Mean|2.6724||0.001|2-Sided|95.0|-13.885|-3.371|||Mixed Models Analysis||||
1605260|NCT02696785|2947426|Superiority||LSMean Difference|-1.49|Standard Error of the Mean|0.423|<|0.001|2-Sided|95.0|-2.32|-0.66|||Mixed Models Analysis||||
1605261|NCT02696785|2947426|Superiority||LSMean Difference|-1.11|Standard Error of the Mean|0.428|<|0.01|2-Sided|95.0|-1.95|-0.27|||Mixed Models Analysis||||
1605262|NCT02696785|2947426|Superiority||LSMean Difference|-1.05|Standard Error of the Mean|0.416|<|0.012|2-Sided|95.0|-1.87|-0.23|||Mixed Models Analysis||||
1605263|NCT02696785|2947427|Superiority||LSMean Difference|0.4467|Standard Error of the Mean|1.1978||0.709|2-Sided|95.0|-1.9097|2.803|||Mixed Models Analysis|||MCS|
1605264|NCT02696785|2947427|Superiority||LSMean Difference|0.6273|Standard Error of the Mean|1.2028||0.602|2-Sided|95.0|-1.7387|2.9934|||Mixed Models Analysis|||MCS|
1605265|NCT02696785|2947427|Superiority||LSMean Difference|0.4321|Standard Error of the Mean|1.1718||0.713|2-Sided|95.0|-1.8732|2.7373|||Mixed Models Analysis|||MCS|
1605266|NCT02696785|2947427|Superiority||LSMean Difference|4.3254|Standard Error of the Mean|1.0641|<|0.001|2-Sided|95.0|2.2321|6.4186|||Mixed Models Analysis|||PCS|
1605267|NCT02696785|2947427|Superiority||LSMean Difference|4.052|Standard Error of the Mean|1.072|<|0.001|2-Sided|95.0|1.9432|6.1608|||Mixed Models Analysis|||PCS|
1605268|NCT02696785|2947427|Superiority||LSMean Difference|3.2574|Standard Error of the Mean|1.0437|<|0.002|2-Sided|95.0|1.2041|5.3106|||Mixed Models Analysis|||PCS|
1605269|NCT02696785|2947428|Superiority||LSMean Difference|-2.39|Standard Error of the Mean|0.452|<|0.001|2-Sided|95.0|-3.3|-1.5|||ANCOVA||||
1605270|NCT02696785|2947428|Superiority||LSMean Difference|-2.62|Standard Error of the Mean|0.45|<|0.001|2-Sided|95.0|-3.5|-1.7|||ANCOVA||||
1605271|NCT02696785|2947428|Superiority||LSMean Difference|-2.78|Standard Error of the Mean|0.447|<|0.001|2-Sided|95.0|-3.7|-1.9|||ANCOVA||||
1605272|NCT02696785|2947429|Superiority||Odds Ratio (OR)|5.13||||0.041|2-Sided|95.0|1.07|24.49|||Regression, Logistic||||
1605273|NCT02696785|2947429|Superiority||Odds Ratio (OR)|8.03||||0.007|2-Sided|95.0|1.75|36.83|||Regression, Logistic||||
1605274|NCT02696785|2947429|Superiority||LSMean Difference|7.62||||0.009|2-Sided|95.0|1.67|34.68|||Regression, Logistic||||
1605275|NCT02696785|2947430|Superiority||LSMean Difference|-1.27|Standard Error of the Mean|0.304|<|0.001|2-Sided|95.0|-1.86|-0.67|||Mixed Models Analysis||||
1605276|NCT02696785|2947430|Superiority||LSMean Difference|-1.22|Standard Error of the Mean|0.307|<|0.001|2-Sided|95.0|-1.83|-0.62|||Mixed Models Analysis||||
1605277|NCT02696785|2947430|Superiority||LSMean Difference|-0.97|Standard Error of the Mean|0.299|<|0.001|2-Sided|95.0|-1.56|-0.39|||Mixed Models Analysis||||
1605278|NCT02696785|2947431|Superiority||Odds Ratio (OR)|3.9|||<|0.001|2-Sided|95.0|1.91|7.98|||Regression, Logistic||||
1605279|NCT02696785|2947431|Superiority||Odds Ratio (OR)|3.74|||<|0.001|2-Sided|95.0|1.82|7.7|||Regression, Logistic||||
1605280|NCT02696785|2947431|Superiority||Odds Ratio (OR)|2.53|||<|0.012|2-Sided|95.0|1.23|5.21|||Regression, Logistic||||
1605281|NCT02696785|2947432|Superiority||LSMean Difference|-0.91|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-1.18|-0.63|||Mixed Models Analysis||||
1605282|NCT02696785|2947432|Superiority||LSMean Difference|-0.97|Standard Error of the Mean|0.141|<|0.001|2-Sided|95.0|-1.25|-0.7|||Mixed Models Analysis||||
1605283|NCT02696785|2947432|Superiority||LSMean Difference|-0.84|Standard Error of the Mean|0.137|<|0.001|2-Sided|95.0|-1.11|-0.57|||Mixed Models Analysis||||
1605284|NCT02696785|2947433|Superiority||Odds Ratio (OR)|3.39|||<|0.001|2-Sided|95.0|1.79|6.41|||Regression, Logistic||||
1605285|NCT02696785|2947433|Superiority||Odds Ratio (OR)|2.78|||<|0.001|2-Sided|95.0|1.48|5.24|||Regression, Logistic||||
1605286|NCT02696785|2947433|Superiority||Odds Ratio (OR)|2.3|||<|0.007|2-Sided|95.0|1.25|4.23|||Regression, Logistic||||
1605287|NCT02696785|2947434|Superiority||LSMean Difference|-8.9|Standard Error of the Mean|3.22|<|0.001|2-Sided|95.0|-15.2|-2.5|||ANCOVA|||Percentage of Activity Impairment|
1605288|NCT02696785|2947434|Superiority||LSMean Difference|-9.3|Standard Error of the Mean|3.19|<|0.001|2-Sided|95.0|-15.5|-3.0|||ANCOVA|||Percentage of Activity Impairment|
1605289|NCT02696785|2947434|Superiority||LSMean Difference|-7.0|Standard Error of the Mean|3.16|<|0.001|2-Sided|95.0|-13.2|-0.7|||ANCOVA|||Percentage of Activity Impairment|
1605290|NCT02696785|2947434|Superiority||Odds Ratio (OR)|5.09|||<|0.001|2-Sided|95.0|2.52|10.28|||Regression, Logistic|||Overall Work Impairment Score.|
1605291|NCT02696785|2947434|Superiority||Odds Ratio (OR)|4.45|||<|0.001|2-Sided|95.0|2.2|9.03|||Regression, Logistic|||Overall Work Impairment Score.|
1605292|NCT02696785|2947434|Superiority||Odds Ratio (OR)|2.73|||<|0.005|2-Sided|95.0|1.35|5.52|||Regression, Logistic|||Overall Work Impairment Score|
1605293|NCT02696434|2947441|Superiority||Odds Ratio (OR)|0.68||||0.407|2-Sided|95.0|0.28|1.68|||Regression, Logistic||||
1605294|NCT02695719|2947469|Superiority||Median Values of CI|1.0||||0.007|2-Sided|95.0|0.1|1.9||No adjustment was made as there was only one primary comparison.|Van Elteren Test|The Van Elteren test is a stratified version of the Wilcoxon-Mann-Whitney test which provides approximate sample size for the van Elteren analysis.|CI was estimated by inverting the hypothesis test.|Assuming equal allocation, a power of 90%, an alpha level of 0.05 for a 2-sided test, a placebo mean of 4 (standard deviation of 2.7), and a treatment mean of 5.9 (standard deviation of 4) for SBM frequency at Week 1 and using Wilcoxon-Mann-Whitney test, a total sample size of 146 is required. Analysis was conducted using van Elteren test.|
1605295|NCT02695537|2947473|Other|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure severity scores over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure severity scores between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure severity scores was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure severity score outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure severity relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.
1605296|NCT02695537|2947474|Other|Single group.|||||<|0.0001||||||P-value reported above is the global test for change in seizure frequency over a 12-month period.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test with Bonferonni multiple comparison correction was used as a post-hoc analysis to indicate direction of change.||Null hypothesis is that there was no change in seizure frequency between any two assessment time points during this period of analysis. Alternative hypothesis is that there were two or more assessment time points for which change in seizure frequency was different from zero.|Generalized least squares statistical techniques were used for modeling longitudinal data after normality of seizure frequency outcome measures were achieved through log-transformations methods. The following baseline clinical variables were adjusted for: AEDs, AEDs tried, epileptic surgery, and gender. Reported results were geometric least squares mean and its associated 95% Confidence Interval. Percentage reduction in seizure frequency relative to baseline were obtained by subtracting from 1 and then multiplying by 100 at all post-baseline timepoints.
1605297|NCT02695420|2947489|Superiority||Treatment Difference|25.5|Standard Error of the Mean|6.5||0.0002|2-Sided|95.0|12.6|38.4|||Repeated measures model||||
1605298|NCT02695420|2947489|Superiority||Treatment Difference|29.3|Standard Error of the Mean|6.5|<|0.0001|2-Sided|95.0|16.3|42.3|||Repeated measures model||||
1605299|NCT02695420|2947489|Superiority||Treatment Difference|22.1|Standard Error of the Mean|6.3|<|0.0008|2-Sided|95.0|9.6|34.7|||Repeated Measures Model||||
1605300|NCT02694978|2947502|Non-Inferiority|The non-inferiority margin of 2.64% was used for the primary endpoint statistical analysis.|Treatment difference|-0.1||||0.0001|2-Sided|95.0|-0.8|0.61|||Wald|The p-value was calculated using the Wald large sample assumption.||"Statistical analysis was only performed on composite reaction data (that is, the Any TE moderate to severe hypersensitivity rxn row in the data table)."|
1605301|NCT02694744|2947505|Superiority||Mean Difference (Final Values)|0.03||||0.7893|2-Sided|95.0|-0.17|0.22|||ANCOVA|||Estimation of mean change in serum potassium from Baseline to week 4.|
1605302|NCT02694744|2947506|Other||||||||||||||||||If the 95% confidence interval for the w/out food Arm overlapped the confidence interval for the w/ food Arm, the study will conclude that there is no evidence of a statistically significant difference between treatment arms.
1605303|NCT02694523|2947534|Other||difference in percentage of participants|38.9|||<|0.001|2-Sided|95.0|22.0|55.8|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).|
1605304|NCT02694523|2947535|Other||difference in percentage of participants|32.8|||<|0.001|2-Sided|95.0|18.8|46.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).|
1605305|NCT02694523|2947536|Other||difference in percentage of participants|32.8|||<|0.001|2-Sided|95.0|18.8|46.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).|
1605306|NCT02694523|2947537|Other||difference in percentage of participants|16.7|||<|0.001|2-Sided|95.0|9.5|23.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).|
1605307|NCT02694523|2947538|Other||difference in percentage of participants|18.9|||<|0.001|2-Sided|95.0|13.0|24.9|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).|
1605308|NCT02694523|2947539|Other||difference in percentage of participants|45.0|||<|0.001|2-Sided|95.0|28.9|61.1|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).|
1605336|NCT02693132|2947567|Superiority||||||<|0.05|||||||ANOVA||||
1607168|NCT02634073|2952054|Superiority or Other||Ratio|0.819|||||2-Sided|90.0|0.766|0.876|||||AUC (0-t) comparision||
1605309|NCT02694523|2947540|Other||difference in percentage of participants|23.3|||<|0.001|2-Sided|95.0|16.6|30.1|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).|
1605310|NCT02694523|2947541|Other||difference in percentage of participants|24.9|||<|0.001|2-Sided|95.0|17.5|32.4|||Cochran-Mantel-Haenszel|||P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to tumor necrosis factor (TNF) antagonists (0 vs ≥1).|
1605311|NCT02694328|2947544|Superiority||Risk Difference (RD)|-15.9||||0.001|2-Sided|95.0|-25.3|-6.5|||Regression, Logistic|Missing values at Week 24 were imputed using multiple imputation.|Risk difference (RD) ALKS 3831 vs. Olanzapine||
1605312|NCT02694328|2947545|Superiority||Risk Difference (RD)|-13.7||||0.003|2-Sided|95.0|-22.8|-4.6||P-value was adjusted using the CHW method to account for the unblinded interim analysis for sample size re-estimation.|Regression, Logistic|Missing values at Week 24 were imputed using multiple imputation.|Risk difference (RD) of ALKS 3831 vs. Olanzapine||
1605313|NCT02694328|2947546|Superiority||Least Squares Mean Difference|-2.38|Standard Error of the Mean|0.765||0.003|2-Sided|95.0|-3.88|-0.88||P-value was adjusted using the Cui, Hung, and Wang (CHW) method to account for the unblinded interim analysis for sample size re-estimation.|ANCOVA|Missing values at Week 24 were imputed using multiple imputation.|||
1605314|NCT02693834|2947551|Other|Repeated measures MANOVA|||||<|0.001||||||Main effect of Practice on gait velocity for fast paced velocity: F(1, 19) = 23.73, ηp2 = .555|repeated measures MANOVA|||Main effect of Practice on gait velocity was analyzed for fast paced velocity|
1605315|NCT02693834|2947551|Other|repeated measures MANOVA|||||<|0.072||||||Main effect of AFO on gait velocity was analyzed at self selected velocity:FPV F(1, 19) = 3.63, ηp2 =.16|repeated measures MANOVA|||Main effect of AFO on gait velocity was analyzed for self selected velocity|
1605316|NCT02693834|2947551|Other|repeated measures MANOVA|||||<|0.28||||||The above p value is for the interaction effects between the type of AFO and practice time at fast paced velocity: F( 1, 19) = 1.24, ηp2 = .61|repeated measures MANOVA|||The significance of differences in gait velocity at fast paced velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.|
1605317|NCT02693834|2947551|Other|Repeated measures MANOVA|||||<|0.001||||||Main effect of practice on gait velocity at self selected velocity:F(1, 19) = 14.38, ηp2 = .431|repeated measures MANOVA|||Main effect of Practice on gait velocity was analyzed at self selected velocity|
1605318|NCT02693834|2947551|Other|Repeated measures MANOVA|||||<|0.32||||||Main effect of AFO on gait velocity at self selected velocity: F(1, 19) = 1.05, ηp2 = .05|repeated measures MANOVA|||Main effect of AFO on gait velocity was analyzed at self selected velocity|
1605319|NCT02693834|2947551|Other|A repeated measures MANOVA|||||<|0.209||||||The above p value is for the interaction effects between the type of AFO and practice time at self selected velocity: F(1, 19) = 1.69, ηp2 = .082|Repeated measures MANOVA|||The significance of differences in gait velocity at self select velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.|
1605320|NCT02693834|2947552|Other|Repeated measures MANOVA||||||0.077||||||The main effect of practice on gait symmetry at fast paced velocity: F(1, 19) = 3.50, ηp2 = .155|repeated measures MANOVA|||The main effect of practice on gait symmetry at fast paced velocity walk was assessed with repeated measures MANOVA|
1605321|NCT02693834|2947552|Other|Repeated measures MANOVA||||||0.918||||||The main effect of AFO on gait symmetry at fast paced velocity: F(1, 19) = 0.01, ηp2 = 0.001|repeated measures MANOVA|||The main effect of AFO on gait symmetry at fast paced velocity walk was assessed with repeated measures MANOVA|
1605322|NCT02693834|2947552|Other|repeated measures MANOVA||||||0.113||||||The above p value is for the interaction effects between type of AFO and practice time for gait symmetry at fast paced velocity FPV F(1, 19) = 2.76,, ηp2 = .127|repeated measures MANOVA|||The significance of differences in gait symmetry at fast paced velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA|
1605323|NCT02693834|2947552|Other|||||||0.26|||||||t-test, 2 sided|||The significance of differences in gait symmetry, between the two AFO conditions at baseline were analyzed using a paired t test for fast paced velocity|
1605324|NCT02693834|2947552|Other|Repeated measures MANOVA||||||0.111||||||The main effect of practice on gait symmetry at self selected velocity F(1, 19) = 2.79, ηp2 = .128|repeated measures MANOVA|||Main effect of practice on gait symmetry at Self selected velocity|
1605325|NCT02693834|2947552|Other|A repeated measures MANOVA||||||0.95||||||Main effect of AFO on gait symmetry at SSV: F(1, 19) = 0.004, ηp2 =.00|Repeated measures MANOVA|||Main effect of AFO on gait symmetry was analyzed at self selected velocity|
1605326|NCT02693834|2947552|Other|repeated measures MANOVA||||||0.397||||||The above p value is for the interaction effects between type of AFO and practice time for gait symmetry at the self selected velocity F(1, 19)= 0.75, ηp2 = .038|repeated measures MANOVA|||The significance of differences in gait symmetry at self select velocity, between the two AFO conditions and two practice conditions were analyzed using repeated measures MANOVA.|
1605327|NCT02693834|2947552|Other|paired t test||||||0.688|||||||t-test, 2 sided|||The significance of differences in gait symmetry, between the two AFO conditions at baseline were analyzed using a paired t test for self selected velocity|
1605328|NCT02693834|2947553|Other|Repeated measures ANOVA|||||<|0.001||||||main effect of practice: F(1, 19) = 43.94, ηp2 = .698|repeated measures ANOVA|||Main effect of practice|
1605329|NCT02693834|2947553|Other|Repeated measures ANOVA|||||<|0.046||||||main effect of the type of AFO: F(1, 19) = 4.58, ηp2= .194|repeated measures ANOVA|||The main effect of type of AFO|
1605330|NCT02693834|2947553|Other|Repeated measures ANOVA|||||<|0.077||||||The above value was the interaction between the type of AFO and practice time.|repeated measures ANOVA|||A repeated measures ANOVA was calculated to find the differences in gait endurance between the type of AFO and practice time.|
1605331|NCT02693834|2947554|Other|Paired t test||||||0.293|||||||t-test, 2 sided|||In order to test the difference in gait endurance,between the two AFO conditions at baseline, a paired t-test was analyzed|
1605332|NCT02693132|2947563|Superiority||||||<|0.05|||||||ANOVA||||
1605333|NCT02693132|2947564|Superiority||||||<|0.05|||||||ANOVA||||
1605334|NCT02693132|2947565|Superiority||||||<|0.05|||||||ANOVA||||
1605337|NCT02692716|2947590|Other|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.81|||<|0.0001|2-Sided|95.0|1.42|2.3||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from date of first dose of trial product to date of end of treatment visit. Time from first dose to first AE leading to permanent trial product discontinuation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the date of their end of treatment visit or at their end of study date, whichever came first.|
1605338|NCT02692716|2947591|Other|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.51||||0.0078|2-Sided|95.0|0.31|0.84||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.|
1605339|NCT02692716|2947592|Other|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.76||||0.4485|2-Sided|95.0|0.37|1.56||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed fatal or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.|
1605340|NCT02692716|2947593|Other|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.04||||0.8583|2-Sided|95.0|0.66|1.66||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the on-treatment observation period. Time from first dose of trial product to first EAC-confirmed fatal or non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their on-treatment observation period.|
1605341|NCT02692716|2947594|Other|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77|||=|0|2-Sided|95.0|0.56|1.05||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed all-cause death, non-fatal myocardial infarction or non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.|
1605342|NCT02692716|2947595|Other|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.86|||=|0|2-Sided|95.0|0.48|1.55||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed hospitalisation for heart failure was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.|
1605343|NCT02692716|2947595|Other|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.56|||=|0|2-Sided|95.0|0.6|4.01||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed unstable angina pectoris requiring hospitalisation was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.|
1605344|NCT02692716|2947595|Other|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.74|||=|0|2-Sided|95.0|0.35|1.57||Unadjusted two-sided p-value for test of no difference from 1|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal stroke was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.|
1605345|NCT02692716|2947595|Other|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.18|||=|0|2-Sided|95.0|0.73|1.9||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed non-fatal myocardial infarction was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.|
1605346|NCT02692716|2947595|Other|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.49|||=|0|2-Sided|95.0|0.27|0.92||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed cardiovascular death (including undetermined cause of death) was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.|
1605347|NCT02692716|2947596|Other|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.82|||=|0|2-Sided|95.0|0.61|1.1||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed expanded cardiovascular outcome was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.|
1605348|NCT02692716|2947597|Superiority|This hypothesis was controlled for multiplicity.|Hazard Ratio (HR)|0.79|||=|0|2-Sided|95.0|0.57|1.11||Unadjusted two-sided p-value from test of no difference from 1 (superiority).|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.|
1605380|NCT02691702|2947641|Other|MMRM|Mean Difference (Final Values)|-27.13|Standard Error of the Mean|38.61|||2-Sided|90.0|-91.24|36.97|||||Test (PF-05251749 50 mg AM) Reference (Placebo)||
1605381|NCT02691702|2947641|Other|MMRM|Mean Difference (Final Values)|-1.26|Standard Error of the Mean|37.24|||2-Sided|90.0|-63.09|60.57|||||Test (Melatonin 0.5 mg PM) Reference (Placebo)||
1605349|NCT02692716|2947597|Non-Inferiority|This hypothesis was controlled for multiplicity. Non-inferiority of oral semaglutide versus placebo was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was strictly below 1.8.|Hazard Ratio (HR)|0.79|||<|0.0001|2-Sided|95.0|0.57|1.11||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority).|Regression, Cox|||Data from the in-trial observation period. Time from randomisation to first event adjudication committee (EAC) confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor and stratified by evidence of cardiovascular disease at screening. Participants were censored at the end of their in-trial observation period.|
1605350|NCT02692703|2947600|Non-Inferiority|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment as compared with the historical rate for the current standard of care regimens (SOF/LDV + RBV or SOF + DCV + RBV) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 86% to achieve noninferiority.|Percentage of Participants|98.0|||||2-Sided|95.0|95.3|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96%, 90 participants provides >90% power to demonstrate noninferiority of the regimen to the historical rate for current standard of care regimens (SOF/LDV + RBV OR SOF + DCV + RBV) (94%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).|
1605351|NCT02692495|2947611|Other||||||<|0.01|||||||t-test, 2 sided||||
1605352|NCT02692417|2947617|Other|||||||0.028|||||||Wilcoxon (Mann-Whitney)||||
1605353|NCT02692417|2947617|Other|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.|
1605354|NCT02692417|2947618|Other|||||||0.046|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.|
1605355|NCT02692417|2947618|Other|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.|
1605356|NCT02692417|2947619|Other|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.|
1605357|NCT02692417|2947619|Other|||||||0.109|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test comparing FSFI score from baseline to time point.|
1605358|NCT02691741|2947636|Superiority|||||||0.003|||||||Repeated Measures Analysis of Variance||||
1605359|NCT02691741|2947636|Non-Inferiority|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|-0.051|Standard Error of the Mean|0.0168|||2-Sided|90.0|-0.078|-0.023|||||||
1605360|NCT02691741|2947637|Superiority|||||||0.455|||||||Repeated Measures Analysis of Variance||||
1605361|NCT02691741|2947637|Non-Inferiority|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|0.012|Standard Error of the Mean|0.0157|||2-Sided|95.0|-0.019|0.043|||||||
1605362|NCT02691741|2947638|Superiority||Mean Difference (Final Values)|-0.061|Standard Error of the Mean|0.0193||0.002|2-Sided|90.0|-0.093|-0.029|||Repeated Measures Analysis of Variance||||
1605363|NCT02691741|2947639|Non-Inferiority|Non-inferiority is demonstrated if the upper confidence limit of the two-sided 90% confidence interval on the treatment difference is less than 0.1 logMAR unit.|Mean Difference (Final Values)|-0.061|Standard Error of the Mean|0.0193|||2-Sided|90.0|-0.093|-0.029|||||||
1605364|NCT02691702|2947640|Other|MMRM|Mean Difference (Final Values)|140.61|Standard Error of the Mean|37.79|||2-Sided|90.0|77.91|203.3|||||Test (PF-05251749 500 mg AM) Reference (Placebo)||
1605365|NCT02691702|2947640|Other|MMRM|Mean Difference (Final Values)|107.29|Standard Error of the Mean|36.13|||2-Sided|90.0|47.31|167.27|||||Test (PF-05251749 200 mg AM) Reference (Placebo)||
1605366|NCT02691702|2947640|Other|MMRM|Mean Difference (Final Values)|92.36|Standard Error of the Mean|35.48|||2-Sided|90.0|33.51|151.21|||||Test (PF-05251749 50 mg PM) Reference (Placebo)||
1605367|NCT02691702|2947640|Other|MMRM|Mean Difference (Final Values)|126.22|Standard Error of the Mean|42.91|||2-Sided|90.0|54.99|197.45|||||Test (PF-05251749 750 mg AM) Reference (Placebo)||
1605368|NCT02691702|2947640|Other|MMRM|Mean Difference (Final Values)|87.3|Standard Error of the Mean|39.37|||2-Sided|90.0|21.94|152.66|||||Test (PF-05251749 400 mg AM) Reference (Placebo)||
1605369|NCT02691702|2947640|Other|MMRM|Mean Difference (Final Values)|46.48|Standard Error of the Mean|40.88|||2-Sided|90.0|-21.38|114.35|||||Test (PF-05251749 200 mg AM) Reference (Placebo)||
1605370|NCT02691702|2947640|Other|MMRM|Mean Difference (Final Values)|88.72|Standard Error of the Mean|45.72|||2-Sided|90.0|12.81|164.62|||||Test (PF-05251749 100 mg AM) Reference (Placebo)||
1605371|NCT02691702|2947640|Other|MMRM|Mean Difference (Final Values)|-12.13|Standard Error of the Mean|38.61|||2-Sided|90.0|-76.24|51.97|||||Test (PF-05251749 50 mg AM) Reference (Placebo)||
1605372|NCT02691702|2947640|Other|MMRM|Mean Difference (Final Values)|-71.26|Standard Error of the Mean|37.24|||2-Sided|90.0|-133.09|-9.43|||||Test (Melatonin 0.5 mg PM) Reference (Placebo)||
1605373|NCT02691702|2947641|Other|MMRM|Mean Difference (Final Values)|174.9|Standard Error of the Mean|36.01|||2-Sided|90.0|115.11|234.69|||||Test (PF-05251749 500 mg PM) Reference (Placebo)||
1605374|NCT02691702|2947641|Other|MMRM|Mean Difference (Final Values)|142.74|Standard Error of the Mean|36.13|||2-Sided|90.0|82.76|202.72|||||Test (PF-05251749 200 mg PM) Reference (Placebo)||
1605375|NCT02691702|2947641|Other|MMRM|Mean Difference (Final Values)|51.42|Standard Error of the Mean|33.12|||2-Sided|90.0|-3.57|106.41|||||Test (PF-05251749 50 mg PM) Reference (Placebo)||
1605376|NCT02691702|2947641|Other|MMRM|Mean Difference (Final Values)|156.22|Standard Error of the Mean|42.91|||2-Sided|90.0|84.99|227.45|||||Test (PF-05251749 750 mg AM) Reference (Placebo)||
1605377|NCT02691702|2947641|Other|MMRM|Mean Difference (Final Values)|125.87|Standard Error of the Mean|39.37|||2-Sided|90.0|60.51|191.23|||||Test (PF-05251749 400 mg AM) Reference (Placebo)||
1605378|NCT02691702|2947641|Other|MMRM|Mean Difference (Final Values)|61.48|Standard Error of the Mean|40.88|||2-Sided|90.0|-6.38|129.35|||||Test (PF-05251749 200 mg AM) Reference (Placebo)||
1605379|NCT02691702|2947641|Other|MMRM|Mean Difference (Final Values)|43.72|Standard Error of the Mean|45.72|||2-Sided|90.0|-32.19|119.62|||||Test (PF-05251749 100 mg AM) Reference (Placebo)||
1605382|NCT02691507|2947724|Superiority or Other||Mean Difference (Final Values)|12.71|Standard Error of the Mean|5.925||0.037|2-Sided|95.0|0.805|24.621||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605383|NCT02691507|2947724|Superiority or Other|||||||0.034||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605384|NCT02691507|2947724|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605385|NCT02691507|2947725|Superiority or Other||Mean Difference (Final Values)|12.77|Standard Error of the Mean|4.222||0.004|2-Sided|95.0|4.291|21.252||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605386|NCT02691507|2947725|Superiority or Other|||||||0.015||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605387|NCT02691507|2947725|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605388|NCT02691507|2947726|Superiority or Other||Mean Difference (Final Values)|14.26|Standard Error of the Mean|4.679||0.004|2-Sided|95.0|4.862|23.66||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605389|NCT02691507|2947726|Superiority or Other|||||||0.024||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605390|NCT02691507|2947726|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605391|NCT02691507|2947727|Superiority or Other||Mean Difference (Final Values)|14.08|Standard Error of the Mean|4.138||0.001|2-Sided|95.0|5.766|22.387||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605392|NCT02691507|2947727|Superiority or Other|||||||0.049||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605393|NCT02691507|2947727|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605394|NCT02691507|2947728|Superiority or Other||Mean Difference (Final Values)|13.25|Standard Error of the Mean|3.764|<|0.001|2-Sided|95.0|5.684|20.82||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605395|NCT02691507|2947728|Superiority or Other||||||<|0.003||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605396|NCT02691507|2947728|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605397|NCT02691507|2947729|Superiority or Other||Mean Difference (Final Values)|16.01|Standard Error of the Mean|4.072|<|0.001|2-Sided|95.0|7.829|24.187||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605398|NCT02691507|2947729|Superiority or Other||||||<|0.009||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605399|NCT02691507|2947729|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605400|NCT02691507|2947730|Superiority or Other||Mean Difference (Final Values)|19.33|Standard Error of the Mean|3.996|<|0.001|2-Sided|95.0|11.301|27.352||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605401|NCT02691507|2947730|Superiority or Other||||||<|0.004||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605701|NCT02683746|2948387|Other||Mean Difference (Net)|0.03|||||2-Sided|95.0|-0.41|0.47|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 9 are presented.||
1605402|NCT02691507|2947730|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605403|NCT02691507|2947731|Superiority or Other||Mean Difference (Final Values)|26.83|Standard Error of the Mean|6.681|<|0.001|2-Sided|95.0|13.407|40.247||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605404|NCT02691507|2947731|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605405|NCT02691507|2947731|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605406|NCT02691507|2947732|Superiority or Other||Mean Difference (Final Values)|-1.27|Standard Error of the Mean|0.772||0.106|2-Sided|95.0|-2.824|0.278||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605407|NCT02691507|2947732|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605408|NCT02691507|2947732|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605409|NCT02691507|2947733|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.798||0.556|2-Sided|95.0|-2.075|1.129||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605410|NCT02691507|2947733|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605411|NCT02691507|2947733|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605412|NCT02691507|2947734|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.774||0.757|2-Sided|95.0|-1.796|1.314||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605413|NCT02691507|2947734|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605414|NCT02691507|2947734|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605415|NCT02691507|2947735|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.735||0.914|2-Sided|95.0|-1.556|1.397||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605416|NCT02691507|2947735|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605417|NCT02691507|2947735|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605418|NCT02691507|2947736|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.708||0.69|2-Sided|95.0|-1.14|1.709||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605419|NCT02691507|2947736|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605420|NCT02691507|2947736|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605421|NCT02691507|2947737|Superiority or Other||Mean Difference (Final Values)|0.73|Standard Error of the Mean|0.846||0.394|2-Sided|95.0|-0.973|2.426||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605702|NCT02683746|2948387|Other||Mean Difference (Net)|0.19|||||2-Sided|95.0|-0.22|0.6|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 8 are presented.||
1605422|NCT02691507|2947737|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605423|NCT02691507|2947737|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605424|NCT02691507|2947738|Superiority or Other||Mean Difference (Final Values)|0.85|Standard Error of the Mean|0.803||0.297|2-Sided|95.0|-0.767|2.46||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605425|NCT02691507|2947738|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605426|NCT02691507|2947738|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605427|NCT02691507|2947739|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.795||0.616|2-Sided|95.0|-1.196|1.998||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1605428|NCT02691507|2947739|Superiority or Other|||||||0.002||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605429|NCT02691507|2947739|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|Paired t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1605430|NCT02690935|2947775|Superiority|||||||0.829||||||No adjustment for multiplicity|t-test, 2 sided|||H0: 2LALERG and placebo have the same effect on the quality of life H1: 2LALERG and placebo do not have the same effect on the quality of life|
1605431|NCT02690935|2947776|Superiority|||||||0.642||||||No adjustment of the p-value|t-test, 2 sided|||H0: The efficacy of 2LALERG and placebo are similar H1: The efficacy of 2LALERG and placebo are different|
1605432|NCT02690727|2947777|Superiority or Other||Ratio (%)|139.27||||0.0278|2-Sided|90.0|111.01|174.73|||ANOVA||||
1605433|NCT02690727|2947779|Superiority or Other||Ratio (%)|128.49||||0.0002|2-Sided|90.0|119.13|138.59|||ANOVA||||
1605434|NCT02690701|2947809|Superiority|This superiority trial compares secukinumab with placebo with a view of demonstrating the superiority of secukinumab over placebo with regards to a specific outcome measure.|Least Square Mean|-0.053|Standard Error of the Mean|0.059||0.3712|2-Sided|95.0|-0.169|0.064|||ANCOVA|||Statistical analysis (Analysis of Covariance) of change from baseline in target to background ratio for regions of the aorta at Week 12 (Full Analysis Set)|
1605435|NCT02689804|2947859|Superiority|||||||0.15|||||||t-test, 2 sided||||
1605436|NCT02689804|2947860|Superiority||||||<|0.01|||||||t-test, 2 sided||||
1605437|NCT02689492|2947863|Other||Intercept|74.8895|Standard Deviation|8.0048|||||||||||Standard deviation is actually standard error.||
1605438|NCT02689492|2947864|Other||Intercept|95.4051|Standard Deviation|6.9951|||||||||||Standard deviation is actually standard error.||
1605439|NCT02689492|2947865|Other||Intercept|68.5027|Standard Deviation|8.0355|||||||||||Standard deviation is actually standard error.||
1605440|NCT02689206|2947911|Other||Mean Difference (Final Values)|1.67|||||2-Sided|95.0|0.77|2.57|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment*time. Model-adjusted treatment difference of dapro 30 mg arm from Placebo along with 95 percent CI are presented.||
1605441|NCT02689206|2947911|Other||Mean Difference (Final Values)|1.47|||||2-Sided|95.0|0.59|2.35|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment*time. Model-adjusted treatment difference of dapro 25 mg arm from Placebo along with 95 percent CI are presented.||
1605442|NCT02689206|2947911|Other||Mean Difference (Final Values)|0.51|||||2-Sided|95.0|-0.4|1.42|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment*time. Model-adjusted treatment difference of dapro 15 mg arm from Placebo along with 95 percent CI are presented.||
1605443|NCT02689206|2947911|Other||Mean Difference (Final Values)|0.57|||||2-Sided|95.0|-0.31|1.45|||||Analysis using a Repeated Measures Model with terms included for baseline, treatment, time and treatment*time. Model-adjusted treatment difference of dapro 10 mg arm from Placebo along with 95 percent CI are presented.||
1605444|NCT02688933|2947923|Superiority||Least Square mean difference|0.22|Standard Error of the Mean|1.15||0.8494|2-Sided|||||Threshold for significance at 0.05 level.|Generalized linear model|Generalized linear model with identity link||Analysis was performed using generalized linear model with identity link, had percentage of time glucose concentration within target range 70-180 mg/dL as dependent variable, treatment group as an independent variable, adjusting variables including baseline characteristics: duration of diabetes, baseline BMI, age, and randomization strata (HbA1c at screening [<8.0% vs ≥8.0%], frequency of Lantus injection at screening, current CGM use [yes/no], and mealtime insulin titration algorithm).|
1605445|NCT02688764|2947953|Superiority|||||||0.5801||||||0.05 level of significance|t-test, 2 sided|||"Group of SP at baseline below or within Age Related Normal Range~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."|
1605703|NCT02683746|2948387|Other||Mean Difference (Net)|0.27|||||2-Sided|95.0|-0.16|0.71|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 7 are presented.||
1607415|NCT02628028|2952543|Superiority|||||||0.67|||||||Regression, Logistic||||
1605446|NCT02688764|2947953|Superiority|||||||0.0058||||||0.05 level of significance|t-test, 2 sided|||"Group of SP at baseline above Age Related Normal Range~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."|
1605447|NCT02688764|2947954|Superiority|||||||0.022||||||0.05 level of significance|t-test, 2 sided|||"Age group of >=12 years to <=18 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."|
1605448|NCT02688764|2947954|Superiority|||||||0.2271||||||0.05 level of significance|t-test, 2 sided|||"Age group of >=6 years to <12 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."|
1605449|NCT02688764|2947954|Superiority|||||||0.5682||||||0.05 level of significance|t-test, 2 sided|||"Age group of >=2 years to <6 years~Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects."|
1605450|NCT02688764|2947972|Superiority|||||||0.3226||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 2 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.|
1605451|NCT02688764|2947972|Superiority|||||||0.6207||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 2 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.|
1605452|NCT02688764|2947973|Superiority|||||||0.0872||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects|
1605453|NCT02688764|2947976|Superiority|||||||0.1465||||||0.05 level of significance|t-test, 2 sided|||Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.|
1605454|NCT02688387|2948025|Equivalence|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0324|||||2-Sided|90.0|0.9929|1.0734|||||Y2 Vs R4, tadalafil||
1605455|NCT02688387|2948025|Equivalence|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0351|||||2-Sided|90.0|1.0002|1.0713|||||Y2 Vs R4, ambrisentan||
1605456|NCT02688387|2948026|Equivalence|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0362|||||2-Sided|90.0|0.991|1.0834|||||Y2 Vs R4, tadalafil||
1605457|NCT02688387|2948026|Equivalence|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0353|||||2-Sided|90.0|1.0009|1.071|||||Y2 Vs R4, ambrisentan||
1605458|NCT02688387|2948027|Equivalence|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.1196|||||2-Sided|90.0|1.0429|1.2019|||||Y2 Vs R4, tadalafil||
1605459|NCT02688387|2948027|Equivalence|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.1176|||||2-Sided|90.0|1.0166|1.2287|||||Y2 Vs R4, ambrisentan||
1605460|NCT02688387|2948028|Equivalence|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9821|||||2-Sided|90.0|0.9145|1.0547|||||Y1 Vs R3, tadalafil||
1605461|NCT02688387|2948028|Equivalence|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0365|||||2-Sided|90.0|1.0138|1.0596|||||Y1 Vs R3, ambrisentan||
1605462|NCT02688387|2948029|Equivalence|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9806|||||2-Sided|90.0|0.9106|1.056|||||Y1 Vs R3, tadalafil||
1605463|NCT02688387|2948029|Equivalence|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.039|||||2-Sided|90.0|1.0168|1.0617|||||Y1 Vs R3, ambrisentan||
1605464|NCT02688387|2948030|Equivalence|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|0.9758|||||2-Sided|90.0|0.9044|1.0529|||||Y1 Vs R3, tadalafil||
1605465|NCT02688387|2948030|Equivalence|Part 3B of the study is set to establish bioequivalence between the Fixed Dose Combination of an additional two dose strengths (ambrisentan 5 mg + tadalafil 40 mg and ambrisentan 5 mg + tadalafil 20 mg).|Ratio|1.0153|||||2-Sided|90.0|0.9348|1.1027|||||Y1 Vs R3, ambrisentan||
1605466|NCT02688387|2948031|Equivalence|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg & tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0122|||||2-Sided|90.0|0.9562|1.0715|||||X2 Vs R2, tadalafil||
1605467|NCT02688387|2948031|Equivalence|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg & tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9612|||||2-Sided|90.0|0.9265|0.9972|||||X1 Vs R1, tadalafil||
1605468|NCT02688387|2948031|Equivalence|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg & tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0144|||||2-Sided|90.0|0.9832|1.0466|||||X2 Vs R2, ambrisentan||
1605469|NCT02688387|2948031|Equivalence|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg & tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0278|||||2-Sided|90.0|0.9943|1.0623|||||X1 Vs R1, ambrisentan||
1605470|NCT02688387|2948032|Equivalence|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg & tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0157|||||2-Sided|90.0|0.9553|1.0799|||||X2 Vs R2, tadalafil||
1605471|NCT02688387|2948032|Equivalence|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg & tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9693|||||2-Sided|90.0|0.931|1.0092|||||X1 Vs R1, tadalafil||
1605472|NCT02688387|2948032|Equivalence|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg & tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0141|||||2-Sided|90.0|0.982|1.0473|||||X2 Vs R2, ambrisentan||
1605473|NCT02688387|2948032|Equivalence|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg & tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.03|||||2-Sided|90.0|0.9965|1.0646|||||X1 Vs R1, ambrisentan||
1605474|NCT02688387|2948033|Equivalence|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg & tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9656|||||2-Sided|90.0|0.9151|1.0188|||||X2 Vs R2, tadalafil||
1605475|NCT02688387|2948033|Equivalence|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg & tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|0.9839|||||2-Sided|90.0|0.9288|1.0423|||||X1 Vs R1, tadalafil||
1605476|NCT02688387|2948033|Equivalence|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg & tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0353|||||2-Sided|90.0|0.9293|1.1534|||||X2 Vs R2, ambrisentan||
1605477|NCT02688387|2948033|Equivalence|Part 3A of the study is designed to test the bioequivalence of a FDC of ambrisentan 10 mg + tadalafil 40 mg (test) relative to reference monotherapies of ambrisentan 10 mg & tadalafil 40 mg taken concurrently (reference) in healthy participants in both the fed and fasted states.|Ratio|1.0667|||||2-Sided|90.0|0.9657|1.1784|||||X1 Vs R1, ambrisentan||
1605478|NCT02688192|2948042|Superiority|||||||0.34|||||||ANOVA|df = 32||Effect of the intervention on changes in upper body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.|
1605479|NCT02688192|2948042|Superiority|||||||0.019|||||||ANOVA|df = 32||Effect of the intervention on changes in lower body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data|
1605480|NCT02688192|2948043|Superiority|||||||0.29|||||||ANOVA|df = 29|||
1605481|NCT02688192|2948044|Superiority|||||||0.85|||||||ANOVA|df = 29||Effects of the intervention on changes in the PedsQL Psychosocial Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.|
1605482|NCT02688192|2948044|Superiority|||||||0.98|||||||ANOVA|df = 33||Effects of the intervention on changes in the PedsQL Physical Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.|
1605483|NCT02688192|2948045|Superiority|||||||0.83|||||||ANOVA|df = 33||Effect of the intervention on changes in the Cognitive Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.|
1605484|NCT02688192|2948045|Superiority|||||||0.49|||||||ANOVA|df = 33||Effects of the intervention on changes in the Sleep/Rest Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.|
1605485|NCT02688192|2948045|Superiority|||||||0.39|||||||ANOVA|df = 33||Effects of the intervention on changes in the General Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.|
1605486|NCT02688153|2948073|Superiority||Median Difference (Final Values)|2.0||||0.8377|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1605487|NCT02688153|2948074|Superiority||Median Difference (Final Values)|-4.5||||0.366|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1605488|NCT02687542|2948099|Other|Bayesian Dose Response Analysis|Bayesian Dose Reponse Estimate|-0.693|Standard Error of the Mean|0.6162||0.5776|2-Sided|90.0|-1.713|0.304||Bayesian Predictive Test for Emax (the additive increase over Placebo in the response of PF-06649751 at a theoretically infinite dose) Monotonicity|Bayesian Dose Response Analysis|Estimate and 90% credible interval of Bayesian dose response difference from placebo|||
1605950|NCT02669082|2949229|Other|||||||0.8166|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.|
1605489|NCT02687529|2948100|Equivalence|The number of positive and negative CST001 assay results for each subject, across all sites and operators were compared. In order for a subject to have a concordant result, the same assay call must be observed for all replicates across all sites (6/6).|proportion of concordant calls|83.33|||||2-Sided|95.0|72.13|91.38|||||||
1605490|NCT02687412|2948101|Superiority||Mean Difference (Final Values)|164.746|Standard Error of the Mean|317.79||0.605|2-Sided|95.0|-465.0|794.0|||t-test, 2 sided||||
1605491|NCT02687412|2948102|Superiority||Mean Difference (Final Values)|-0.10046|Standard Error of the Mean|0.1915||0.601|2-Sided|95.0|-0.4819|0.2817|||t-test, 2 sided||||
1605492|NCT02687412|2948103|Superiority|||||||1|||||||Chi-squared||||
1605493|NCT02687412|2948104|Superiority|||||||1|||||||Chi-squared||||
1605494|NCT02687412|2948105|Superiority|||||||1|||||||Chi-squared||||
1605495|NCT02687412|2948106|Superiority|||||||1|||||||Chi-squared||||
1605496|NCT02687412|2948107|Superiority|||||||0.034|||||||Chi-squared||||
1605497|NCT02687412|2948108|Superiority|||||||0.014|||||||Chi-squared||||
1605498|NCT02687412|2948109|Superiority||Mean Difference (Final Values)|20.3739|Standard Error of the Mean|6.4198||0.002|2-Sided|95.0|7.6414|33.1065|||t-test, 2 sided||||
1605499|NCT02687412|2948110|Superiority||Mean Difference (Final Values)|-4041.0|Standard Error of the Mean|1831.042||0.029|2-Sided|95.0|-7672.301|-411.065|||t-test, 2 sided||||
1605500|NCT02687412|2948111|Superiority|||||||0.141|||||||t-test, 2 sided||||
1605501|NCT02687217|2948112|Superiority or Other|||||||0.5|||||||Chi-squared||||
1605502|NCT02687217|2948113|Superiority or Other|||||||0.5|||||||Chi-squared||||
1605503|NCT02687217|2948114|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1605504|NCT02686164|2948145|Other||Geometric Mean Ratio|0.94|||||2-Sided|90.0|0.845|1.046||||||Cmax of 1’-hydroxy midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam|
1605505|NCT02686164|2948145|Other||Geometric Mean Ratio|1.055|||||2-Sided|90.0|0.879|1.268||||||Cmax of 1’-hydroxy midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam|
1605506|NCT02686164|2948145|Other||Geometric Mean Ratio|1.027|||||2-Sided|90.0|0.852|1.238||||||Cmax of Midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam|
1605507|NCT02686164|2948145|Other||Geometric Mean Ratio|0.862|||||2-Sided|90.0|0.753|0.988||||||Cmax of Midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam|
1605508|NCT02686164|2948146|Other||Geometric Mean Ratio|1.199|||||2-Sided|90.0|1.057|1.36||||||AUC(0-24) of 1’-hydroxy midazolam: Cycle 1 Day 14, Lenvatinib (steady-state) + Midazolam vs.Cycle 1 Day -3, Midazolam|
1605509|NCT02686164|2948146|Other||Geometric Mean Ratio|1.12|||||2-Sided|90.0|0.94|1.335||||||AUC(0-24) of 1’-hydroxy midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam vs. Cycle 1 Day -3, Midazolam|
1605510|NCT02686164|2948146|Other||Geometric Mean Ratio|1.148|||||2-Sided|90.0|0.938|1.404||||||AUC(0-24) of Midazolam: Cycle 1 Day 14, Lenvatinib (steady state) + Midazolam vs. Cycle 1 Day -3, Midazolam|
1605511|NCT02686164|2948146|Other||Geometric Mean Ratio|0.914|||||2-Sided|90.0|0.85|0.983||||||AUC(0-24) of Midazolam: Cycle 1 Day 1, Lenvatinib (single-dose) + Midazolam Versus (vs.) Cycle 1 Day -3, Midazolam|
1605512|NCT02686138|2948147|Superiority||Risk Difference (RD)|9.17||||0.015|2-Sided||||||Cochran-Mantel-Haenszel||||
1605513|NCT02686138|2948148|Superiority||Risk Difference (RD)|16.18|||<|0.001|2-Sided||||||Cochran-Mantel-Haenszel||||
1605514|NCT02686138|2948149|Superiority||Risk Difference (RD)|13.1|||<|0.001|2-Sided||||||Cochran-Mantel-Haenszel||||
1605515|NCT02686138|2948150|Superiority||Risk Difference (RD)|10.17||||0.013|2-Sided||||||Cochran-Mantel-Haenszel||||
1605516|NCT02686138|2948151|Superiority||Risk Difference (RD)|10.3||||0.01|2-Sided||||||Cochran-Mantel-Haenszel||||
1605517|NCT02686138|2948152|Superiority||Risk Difference (RD)|11.16||||0.003|2-Sided||||||Cochran-Mantel-Haenszel||||
1605518|NCT02686138|2948153|Superiority||Risk Difference (RD)|11.5||||0.004|2-Sided||||||Cochran-Mantel-Haenszel||||
1605519|NCT02686138|2948154|Superiority||Risk Difference (RD)|14.11|||<|0.001|2-Sided||||||Cochran-Mantel-Haenszel||||
1605520|NCT02686138|2948155|Superiority||Risk Difference (RD)|12.85|||<|0.001|2-Sided||||||Cochran-Mantel-Haenszel||||
1605521|NCT02685072|2948222|Superiority||Odds Ratio (OR)|0.7172||||0.6449|2-Sided|95.0|0.1738|2.9594|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of prolonged abstinence in TPN + progesterone versus TPN + placebo.||
1605522|NCT02685072|2948223|Superiority||Odds Ratio (OR)|0.7172||||0.6449|2-Sided|95.0|0.1738|2.9594|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO < 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.||
1605523|NCT02685072|2948234|Superiority||Mean Difference (Final Values)|9.26||||0.0065|2-Sided|95.0|2.71|15.81|||t-test, 2 sided||||
1605524|NCT02685072|2948235|Superiority||Mean Difference (Final Values)|0.148||||0.791|2-Sided|95.0|-0.9747|1.2707|||t-test, 2 sided||(placebo + TPN) - (progesterone + TPN)||
1605525|NCT02685072|2948236|Superiority||Mean Difference (Final Values)|-9.1|Standard Deviation|31.7||0.31|2-Sided|95.0|-27.1|9.0|||t-test, 2 sided||(Placebo + TPN) - (Progesterone + TPN)||
1605526|NCT02685072|2948237|Superiority||Odds Ratio (OR)|0.913||||0.8661|2-Sided|95.0|0.3171|2.6287|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO < 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.||
1605527|NCT02685072|2948238|Superiority||Odds Ratio (OR)|0.7619||||0.662|2-Sided|95.0|0.2247|2.5838|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO < 10 ppm (negative for smoking) in TPN + progesterone versus TPN + placebo.||
1605528|NCT02685072|2948239|Superiority||Odds Ratio (OR)|1.0781||||0.8944|2-Sided|95.0|0.355|3.2744|||Chi-squared|degrees of freedom = 1|Odds ratio represents odds of CO < 10 (negative for smoking) in TPN + progesterone versus TPN + placebo groups||
1605529|NCT02685072|2948240|Superiority||Odds Ratio (OR)|0.5818||||0.3253|2-Sided|95.0|0.1968|1.7202|||Chi-squared|degrees of freedom =1|Odds ratio represents odds of smoking abstinence in TPN + progesterone group versus TPN + placebo group||
1605530|NCT02684981|2948258|Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Median convenience and satisfaction PACT-Q2 scores at last assessment compared to second assessment|
1605531|NCT02684981|2948266|Other||Mean Difference (Net)|19.011|Standard Error of the Mean|0.408|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)|
1605532|NCT02684981|2948266|Other||Mean Difference (Net)|15.884|Standard Error of the Mean|0.388|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in satisfaction PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)|
1605533|NCT02684981|2948267|Other||Mean Difference (Net)|23.341|Standard Error of the Mean|0.509|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at continuation stage (V3)|
1605534|NCT02684981|2948267|Other||Mean Difference (Net)|18.377|Standard Error of the Mean|0.514|<|0.001|||||||Mixed Models Analysis||The primary analysis of PACT-Q2 scores was based on the random intercept model, where the matched group is considered as a random effect, the treatment as a fixed effect and the score as the response variable.|Mean change in convenience PACT-Q2 scores between VKA and Pradaxa therapy at initiation stage (V2)|
1605535|NCT02684981|2948268|Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V3|
1605536|NCT02684981|2948268|Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in satisfaction PACT-Q2 scores from V1 to V2|
1605537|NCT02684981|2948269|Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in convenience PACT-Q2 scores from V1 to V3|
1605538|NCT02684981|2948269|Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis||Statistical analysis for median change in PACT-Q2 scores from V1 to V2|
1605539|NCT02684630|2948276|Other|A procedure is a success if the donor’s post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple sample proportion|1.0|Standard Deviation|0.0|||1-Sided|95.0|0.951||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence."|
1605540|NCT02684630|2948277|Other|A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.|Simple sample proportion|1.0|Standard Deviation|0.0|||1-Sided|95.0|0.951||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|"Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence."|
1605541|NCT02684604|2948278|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1605542|NCT02684370|2948295|Other||Mean Difference (Final Values)|-5.765|||<|0.001|2-Sided|95.0|-6.496|-5.035|||van Elteren test|||P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).|
1605543|NCT02684370|2948296|Other||adjusted difference in percentage|23.0|||<|0.001|2-Sided|95.0|11.9|34.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605544|NCT02684370|2948297|Other||adjusted difference in percentage|17.3|||<|0.001|2-Sided|95.0|7.3|27.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605545|NCT02684370|2948298|Other||adjusted difference in percentage|17.0|||<|0.001|2-Sided|95.0|7.4|26.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605546|NCT02684370|2948299|Other||adjusted difference in percentage|36.5|||<|0.001|2-Sided|95.0|27.0|45.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605547|NCT02684370|2948300|Other||adjusted difference in percentage|35.1|||<|0.001|2-Sided|95.0|25.7|44.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605704|NCT02683746|2948387|Other||Mean Difference (Net)|0.15|||||2-Sided|95.0|-0.26|0.55|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 6 are presented.||
1605548|NCT02684370|2948301|Other||adjusted difference in percentage|38.3|||<|0.001|2-Sided|95.0|27.9|48.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.|P-value calculated according to the Cochran-Mantel-Haenszel test adjusted for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).|
1605549|NCT02684370|2948302|Other||adjusted difference in percentage|22.9|||<|0.001|2-Sided|95.0|14.3|31.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605550|NCT02684370|2948303|Other||adjusted difference in percentage|23.8|||<|0.001|2-Sided|95.0|15.5|32.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605551|NCT02684370|2948304|Other||adjusted difference in percentage|25.1|||<|0.001|2-Sided|95.0|15.2|35.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605552|NCT02684370|2948305|Other||adjusted difference in percentage|33.5|||<|0.001|2-Sided|95.0|22.7|44.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605553|NCT02684370|2948306|Other||adjusted difference in percentage|27.1|||<|0.001|2-Sided|95.0|21.2|32.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605554|NCT02684370|2948307|Other||adjusted difference in percentage|57.9|||<|0.001|2-Sided|95.0|50.4|65.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605555|NCT02684370|2948308|Other||adjusted difference in percentage|35.5|||<|0.001|2-Sided|95.0|30.0|41.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605556|NCT02684370|2948309|Other||adjusted difference in percentage|34.7|||<|0.001|2-Sided|95.0|28.6|40.8||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605557|NCT02684370|2948310|Other||adjusted difference in percentage|79.9|||<|0.001|2-Sided|95.0|73.5|86.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to TNF antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605558|NCT02684370|2948311|Other||adjusted difference in percentage|70.3|||<|0.001|2-Sided|95.0|64.0|76.7||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by Cochran-Mantel-Haenszel test adjusted for strata. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605559|NCT02684357|2948312|Other||Adjusted percentage difference|14.7||||0.001|2-Sided|95.0|5.9|23.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605560|NCT02684357|2948313|Other||Adjusted percentage difference|29.1|||<|0.001|2-Sided|95.0|18.5|39.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605951|NCT02669082|2949230|Other|||||||0.042|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.|
1605561|NCT02684357|2948314|Other||Adjusted percentage difference|84.7|||<|0.001|2-Sided|95.0|79.0|90.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605562|NCT02684357|2948315|Other||Mean Difference (Final Values)|-6.375|||<|0.001|2-Sided|95.0|-7.102|-5.648|||van Elteren test|||P-value calculated by the van Elteren test stratified for baseline weight (≤100 kg vs >100 kg) and prior exposure to TNF antagonists (0 vs ≥1).|
1605563|NCT02684357|2948316|Other||Adjusted percentage difference|20.2|||<|0.001|2-Sided|95.0|9.1|31.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605564|NCT02684357|2948317|Other||Adjusted percentage difference|18.0|||<|0.001|2-Sided|95.0|7.8|28.3||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605565|NCT02684357|2948318|Other||Adjusted percentage difference|19.2|||<|0.001|2-Sided|95.0|9.5|28.8||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605566|NCT02684357|2948319|Other||Adjusted percentage difference|29.5|||<|0.001|2-Sided|95.0|18.9|40.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605567|NCT02684357|2948320|Other||Adjusted percentage difference|29.5|||<|0.001|2-Sided|95.0|18.9|40.1||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605568|NCT02684357|2948321|Other||Adjusted percentage difference|30.2|||<|0.001|2-Sided|95.0|19.6|40.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605569|NCT02684357|2948322|Other||Adjusted percentage difference|26.3|||<|0.001|2-Sided|95.0|16.1|36.4||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605570|NCT02684357|2948323|Other||Adjusted percentage difference|27.0|||<|0.001|2-Sided|95.0|17.0|37.0||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605571|NCT02684357|2948324|Other||Adjusted percentage difference|22.3|||<|0.001|2-Sided|95.0|12.0|32.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605572|NCT02684357|2948325|Other||Adjusted percentage difference|27.6|||<|0.001|2-Sided|95.0|16.7|38.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605573|NCT02684357|2948326|Other||Adjusted percentage difference|31.2|||<|0.001|2-Sided|95.0|25.7|36.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605574|NCT02684357|2948327|Other||Adjusted percentage difference|62.2|||<|0.001|2-Sided|95.0|55.5|68.9||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605575|NCT02684357|2948328|Other||Adjusted percentage difference|48.2|||<|0.001|2-Sided|95.0|41.9|54.6||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605576|NCT02684357|2948329|Other||Adjusted percentage difference|47.5|||<|0.001|2-Sided|95.0|40.9|54.2||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605577|NCT02684357|2948330|Other||Adjusted percentage difference|78.5|||<|0.001|2-Sided|95.0|72.4|84.5||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated by the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605578|NCT02684357|2948331|Other||Adjusted percentage difference|72.5|||<|0.001|2-Sided|95.0|66.8|78.2||Cochran-Mantel-Haenszel test adjusted for strata (baseline weight [≤100 kg vs >100 kg] and prior exposure to tumor necrosis factor [TNF] antagonists [0 vs ≥1]). If there was a stratum containing zero count, 0.1 was added to each cell.|Cochran-Mantel-Haenszel||95% CI for adjusted difference of 2 treatment groups, calculated from the Cochran-Mantel-Haenszel test adjusted for the comparison of 2 treatment groups. If there was a stratum containing zero count, 0.1 was added to each cell.||
1605579|NCT02684188|2948333|Superiority|||||||0.857||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 90 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 90.|For day 90, 83 (50 baseline and 33 intervention) patients were used in this analysis.
1605580|NCT02684188|2948333|Superiority|||||||0.848||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 60 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 60.|For day 60, 87 (54 baseline and 33 intervention) patients were used in this analysis.
1605581|NCT02684188|2948333|Superiority|||||||0.779||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 30 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 30.|For day 30, 95 (57 baseline and 38 intervention) patients were used in this analysis.
1605582|NCT02684188|2948333|Superiority|||||||0.78|||||||Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 21 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 21.|This Hypothesis was tested with no adjustments for covariates since none were significant.
1605583|NCT02684188|2948333|Superiority|||||||0.329|||||||Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 14 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 14.|For day 14, 105 (62 baseline and 43 intervention) patients were used in this analysis.
1605584|NCT02684188|2948333|Superiority|||||||0.479||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||H0: There is no difference in the cumulative number of PCP visits for day 7 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 7.|For day 7, 111 (67 baseline and 44 intervention) patients were used in this analysis.
1605585|NCT02684188|2948333|Superiority|||||||0.717||||||This Hypothesis was tested with no adjustments for covariates since none were significant.|Regression, Logistic|||: H0: There is no difference in the cumulative number of PCP visits for day 3 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 3.|For day 3, 114 (70 baseline and 44 intervention) patients were used in this analysis.
1605586|NCT02684188|2948334|Superiority|||||||0.742|||||||ANOVA|||The following hypotheses were tested: H0: There is no difference in the mean RTM14 score between the standard and enhanced discharge groups (null hypothesis); H1: Patients in the enhanced discharge group will have a higher mean RTM14 rating than patients in the standard discharge group.|A repeated measures ANOVA model (over the 6 time measurement periods) was used to model the RTM14 score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, income, and whether or not a patient had visited a hospital or ED prior to that day. The hypothesis test for the group comparison was 1-sided, hypotheses to assess significance of covariates were 2-sided, and p-values < 0.05 were considered statistically significant. The covariates Sex, Number in household, LACE+ score, and PAM10 score were not significant in explaining SF-12 scores so were not retained in the model.
1605952|NCT02669082|2949231|Other|||||||0.022|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.|
1605587|NCT02684188|2948335|Superiority|||||||0.806|||||||ANCOVA|||The following hypotheses were tested: H0: There is no difference in the mean CTM3 score between the standard and enhanced discharge groups (null hypothesis); H1: Patients in the enhanced discharge group will have a higher mean CTM3 rating than patients in the standard discharge group.|An analysis of covariance was used to model the CTM3 discharge planning score as a function of treatment group. An ANOVA F-test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of patient age and income. The hypothesis test for the group comparison was 1-sided, hypotheses to assess significance of covariates were 2-sided, and p-values < 0.05 were considered statistically significant. The covariates Sex, County, Number in Household, LACE+ score, and PAM10 score did not differ in their mean CTM3 scores so were not retained in the model.
1605588|NCT02684188|2948336|Equivalence|A repeated measures ANOVA model was used to model the SF-12 Mental Health score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, income, and county. All hypotheses were 2-sided and p-values < 0.05 were considered statistically significant.||||||0.232||||||The P-value comparing the means for the 2 groups averaged across the 7 days is p = 0.232, after adjusting for covariates.|ANOVA|||The following hypotheses were tested: Hoi: There is no difference in mean SF-12 Mental Health scores between the standard and enhanced discharge groups (null hypothesis); H1i: The mean SF-12 Mental Health scores differ between the standard and enhanced discharge groups.|
1605589|NCT02684188|2948337|Equivalence|A repeated measures ANOVA model was used to model the SF12 Physical Health score as a function of treatment group. The likelihood ratio test was used to calculate the p-values for the treatment effect and covariates. No adjustments for multiple comparisons were made. Hypotheses were tested after adjusting for the effects of the repeated measures, patient age, and the number of people in a household. All hypotheses were 2-sided and p-values < 0.05 were considered statistically significant.||||||0.371||||||The P-value comparing the means for the 2 groups averaged across the 7 days is p = 0.371, after adjusting for covariates.|ANOVA|||The following hypotheses were tested: Hoi: There is no difference in mean SF12 Physical Health scores between the standard and enhanced discharge groups (null hypothesis); H1i: The mean SF12 Physical Health scores differ between the standard and enhanced discharge groups.|
1605590|NCT02684188|2948338|Superiority|||||||0.995|||||||Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 90 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 90.|For day 90, 83 (50 baseline and 33 intervention) patients were used in this analysis.
1605591|NCT02684188|2948338|Superiority|||||||0.999||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.|Poisson regression|P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.||H0: There is no difference in the cumulative number of PCP visits for day 60 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 60.|For day 60, 87 (54 baseline and 33 intervention) patients were used in this analysis.
1605592|NCT02684188|2948338|Superiority|||||||0.919||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 30 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 30.|For day 30, 95 (57 baseline and 38 intervention) patients were used in this analysis.
1605593|NCT02684188|2948338|Superiority|||||||0.765||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 21 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 21.|For day 21, 98 (58 baseline and 40 intervention) patients were used in this analysis.
1605594|NCT02684188|2948338|Superiority|||||||0.541||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 14 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 14.|For day 14, 105 (62 baseline and 43 intervention) patients were used in this analysis.
1605595|NCT02684188|2948338|Superiority|||||||0.613|||||||Poisson regression|||H0: There is no difference in the cumulative number of PCP visits for day 7 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 7.|For day 7, 111 (67 baseline and 44 intervention) patients were used in this analysis.
1605596|NCT02684188|2948338|Superiority|||||||0.946||||||P-values comparing the counts for the 2 groups after adjusting for sex, age, number in household, county, and LACE+ score.|Poisson regression|||The following hypotheses were tested: H0: There is no difference in the cumulative number of PCP visits for day 3 (null hypothesis); H1: The cumulative number of PCP visits for the standard discharge group is less than that for the enhanced discharge group for day 3.|For day 3, 114 (70 baseline and 44 intervention) patients were used in this analysis.
1605597|NCT02684188|2948339|Superiority|||||||0.368||||||Comments (covariates): P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 90; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 86 (51 baseline and 35 intervention) patients were used in this analysis.
1605598|NCT02684188|2948339|Superiority|||||||0.394||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 60; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 90 (55 baseline and 35 intervention) patients were used in this analysis.
1605705|NCT02683746|2948387|Other||Mean Difference (Net)|0.19|||||2-Sided|95.0|-0.19|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 5 are presented.||
1605599|NCT02684188|2948339|Superiority|||||||0.462||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 30; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 98 (58 baseline and 40 intervention) patients were used in this analysis.
1605600|NCT02684188|2948339|Superiority|||||||0.472||||||Comments (covariates): P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 21; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 101 (59 baseline and 42 intervention) patients were used in this analysis.
1605601|NCT02684188|2948339|Superiority|||||||0.558||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 14; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 107 (63 baseline and 44 intervention) patients were used in this analysis.
1605602|NCT02684188|2948339|Superiority|||||||0.504||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 7; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 113 (68 baseline and 45 intervention) patients were used in this analysis.
1605603|NCT02684188|2948339|Superiority|||||||0.597||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 3; H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 115 (70 baseline and 45 intervention) patients were used in this analysis.
1605604|NCT02684188|2948340|Superiority|||||||0.126||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 90 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 86 (51 baseline and 35 intervention) patients were used in this analysis.
1605605|NCT02684188|2948340|Superiority|||||||0.116||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 60 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 90 (55 baseline and 35 intervention) patients were used in this analysis.
1605606|NCT02684188|2948340|Superiority|||||||0.22||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 30 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 98 (58 baseline and 40 intervention) patients were used in this analysis.
1605607|NCT02684188|2948340|Superiority|||||||0.25||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 21 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 101 (59 baseline and 42 intervention) patients were used in this analysis.
1605608|NCT02684188|2948340|Superiority|||||||0.347||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 14 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 107 (63 baseline and 44 intervention) patients were used in this analysis.
1605609|NCT02684188|2948340|Superiority|||||||0.286||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of ED visits for day 7 (null hypothesis); H1: The cumulative number of ED visits for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 113 (68 baseline and 45 intervention) patients were used in this analysis.
1605610|NCT02684188|2948340|Superiority|||||||0.502||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 3 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 115 (70 baseline and 45 intervention) patients were used in this analysis.
1605611|NCT02684188|2948341|Superiority|H0: There is no difference in the proportion of patients with at least one ED visits by day 90 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 90.||||||0.381||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic||||For day 90, 83 (49 baseline and 34 intervention) patients were used in this analysis.
1605612|NCT02684188|2948341|Superiority|||||||0.452||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 60 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 87 (53 baseline and 34 intervention) patients were used in this analysis.
1605613|NCT02684188|2948341|Superiority|||||||0.478||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 30 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 95 (56 baseline and 39 intervention) patients were used in this analysis.
1605706|NCT02683746|2948387|Other||Mean Difference (Net)|-0.03|||||2-Sided|95.0|-0.42|0.36|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 4 are presented.||
1605614|NCT02684188|2948341|Superiority|||||||0.191||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 21 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 98 (57 baseline and 41 intervention) patients were used in this analysis.
1605615|NCT02684188|2948341|Superiority|||||||0.424||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 14 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 104 (61 baseline and 43 intervention) patients were used in this analysis.
1605616|NCT02684188|2948341|Superiority|||||||0.211||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 7 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 110 (66 baseline and 44 intervention) patients were used in this analysis.
1605617|NCT02684188|2948341|Superiority|||||||0.279||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Regression, Logistic|||H0: There is no difference in the proportion of patients with at least one ED visits by day 3 (null hypothesis); H1: The proportion of patients with at least one ED visit for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 112(68 baseline and 44 intervention) patients were used in this analysis.
1605618|NCT02684188|2948342|Superiority|||||||0.137||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 90 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 90.|For day 90, 83 (49 baseline and 34 intervention) patients were used in this analysis.
1605619|NCT02684188|2948342|Superiority|||||||0.055|||||||Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 60 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 60.|For day 60, 87 (53 baseline and 34 intervention) patients were used in this analysis.
1605620|NCT02684188|2948342|Superiority|||||||0.05||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 30 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 30.|For day 30, 95 (56 baseline and 39 intervention) patients were used in this analysis.
1605621|NCT02684188|2948342|Superiority|||||||0.011||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 21 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 21.|For day 21, 98 (57 baseline and 41 intervention) patients were used in this analysis.
1605622|NCT02684188|2948342|Superiority|||||||0.037||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 14 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 14.|For day 14, 104 (61 baseline and 43 intervention) patients were used in this analysis.
1605623|NCT02684188|2948342|Superiority|||||||0.025||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 7 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 7.|For day 7, 110 (66 baseline and 44 intervention) patients were used in this analysis.
1605624|NCT02684188|2948342|Superiority|||||||0.03||||||P-values comparing the counts for the 2 groups after adjusting for PAM10.|Poisson regression|||H0: There is no difference in the cumulative number of hospital visits for day 3 (null hypothesis); H1: The cumulative number of hospital visits for the standard discharge group is greater than that for the enhanced discharge group for day 3.|For day 3, 112(68 baseline and 44 intervention) patients were used in this analysis.
1605625|NCT02683954|2948349|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Normality of numerical data distribution was examined by the Shapiro-Wilk. Normally distributed numerical variables were presented as mean±SD and inter-group differences were compared using unpaired t test. Skewed numerical variables were presented as median and interquartile range and between-group differences were compared using Mann-Whitney U test. Ordinal data were compared using the chi-squared test for trend. Correlations among numerical variables were tested by Spearman rank correlation.|
1605626|NCT02683785|2948369|Other||Mean Difference (Net)|-1.1||||0.109|2-Sided|95.0|-2.4|0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented||
1605627|NCT02683785|2948369|Other||Mean Difference (Net)|-0.9||||0.186|2-Sided|95.0|-2.2|0.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented||
1605628|NCT02683785|2948369|Other||Mean Difference (Net)|-0.7||||0.271|2-Sided|95.0|-1.9|0.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented||
1605707|NCT02683746|2948387|Other||Mean Difference (Net)|-0.01|||||2-Sided|95.0|-0.42|0.4|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 3 are presented.||
1605629|NCT02683785|2948369|Other||Mean Difference (Net)|-0.2||||0.651|2-Sided|95.0|-1.3|0.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented.||
1605630|NCT02683785|2948370|Other||Mean Difference (Net)|-0.3||||0.687|2-Sided|95.0|-2.1|1.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented||
1605631|NCT02683785|2948370|Other||Mean Difference (Net)|-1.2||||0.12|2-Sided|95.0|-2.8|0.3||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented||
1605632|NCT02683785|2948370|Other||Mean Difference (Net)|-0.5||||0.416|2-Sided|95.0|-1.9|0.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented||
1605633|NCT02683785|2948370|Other||Mean Difference (Net)|0.3||||0.586|2-Sided|95.0|-0.9|1.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented||
1605634|NCT02683785|2948371|Other||Mean Difference (Net)|-0.5||||0.806|2-Sided|95.0|-4.8|3.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented||
1605635|NCT02683785|2948371|Other||Mean Difference (Net)|-0.7||||0.736|2-Sided|95.0|-4.9|3.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented||
1605636|NCT02683785|2948371|Other||Mean Difference (Net)|-1.4||||0.464|2-Sided|95.0|-5.4|2.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented||
1605637|NCT02683785|2948371|Other||Mean Difference (Net)|-0.5||||0.783|2-Sided|95.0|-4.2|3.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented||
1605638|NCT02683785|2948371|Other||Mean Difference (Net)|-1.9||||0.324|2-Sided|95.0|-5.8|2.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented||
1605639|NCT02683785|2948371|Other||Mean Difference (Net)|-0.4||||0.809|2-Sided|95.0|-3.7|2.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented||
1605640|NCT02683785|2948371|Other||Mean Difference (Net)|-1.2||||0.463|2-Sided|95.0|-4.4|2.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented||
1605641|NCT02683785|2948372|Other||Mean Difference (Net)|-0.2||||0.883|2-Sided|95.0|-2.8|2.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented||
1605642|NCT02683785|2948372|Other||Mean Difference (Net)|-0.3||||0.848|2-Sided|95.0|-3.4|2.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented||
1605643|NCT02683785|2948372|Other||Mean Difference (Net)|0.2||||0.875|2-Sided|95.0|-2.5|2.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented||
1605644|NCT02683785|2948372|Other||Mean Difference (Net)|1.4||||0.243|2-Sided|95.0|-1.0|3.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented||
1605645|NCT02683785|2948372|Other||Mean Difference (Net)|-0.5||||0.624|2-Sided|95.0|-2.7|1.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented||
1605646|NCT02683785|2948372|Other||Mean Difference (Net)|0.3||||0.775|2-Sided|95.0|-2.1|2.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented||
1605647|NCT02683785|2948372|Other||Mean Difference (Net)|0.0||||0.957|2-Sided|95.0|-1.9|1.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented||
1605648|NCT02683785|2948373|Other||Mean Difference (Net)|-13.3||||0.127|2-Sided|95.0|-30.5|3.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 12||
1605649|NCT02683785|2948373|Other||Mean Difference (Net)|-12.1||||0.16|2-Sided|95.0|-29.1|5.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 10||
1605650|NCT02683785|2948373|Other||Mean Difference (Net)|-9.0||||0.278|2-Sided|95.0|-25.4|7.5||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 8||
1605651|NCT02683785|2948373|Other||Mean Difference (Net)|-3.4||||0.648|2-Sided|95.0|-18.4|11.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 6||
1605652|NCT02683785|2948373|Other||Mean Difference (Net)|-8.7||||0.207|2-Sided|95.0|-22.4|5.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 4||
1605653|NCT02683785|2948373|Other||Mean Difference (Net)|-4.6||||0.381|2-Sided|95.0|-15.2|5.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 2||
1605654|NCT02683785|2948373|Other||Mean Difference (Net)|-5.5||||0.23|2-Sided|95.0|-14.5|3.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Total of all component scores, Week 1||
1605655|NCT02683785|2948373|Other||Mean Difference (Net)|-8.2||||0.136|2-Sided|95.0|-19.1|2.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 12||
1605656|NCT02683785|2948373|Other||Mean Difference (Net)|-6.2||||0.266|2-Sided|95.0|-17.3|4.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 10||
1605657|NCT02683785|2948373|Other||Mean Difference (Net)|-4.9||||0.343|2-Sided|95.0|-15.2|5.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 8||
1605658|NCT02683785|2948373|Other||Mean Difference (Net)|-2.7||||0.565|2-Sided|95.0|-12.1|6.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 6||
1605659|NCT02683785|2948373|Other||Mean Difference (Net)|-4.8||||0.271|2-Sided|95.0|-13.5|3.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 4||
1605660|NCT02683785|2948373|Other||Mean Difference (Net)|-3.0||||0.383|2-Sided|95.0|-9.8|3.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 2||
1605661|NCT02683785|2948373|Other||Mean Difference (Net)|-2.9||||0.35|2-Sided|95.0|-9.0|3.3||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Physical Function component, Week 1||
1605662|NCT02683785|2948373|Other||Mean Difference (Net)|-0.8||||0.248|2-Sided|95.0|-2.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 12||
1605663|NCT02683785|2948373|Other||Mean Difference (Net)|-0.6||||0.331|2-Sided|95.0|-1.9|0.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 10||
1605664|NCT02683785|2948373|Other||Mean Difference (Net)|-0.7||||0.213|2-Sided|95.0|-1.9|0.4||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 8||
1605665|NCT02683785|2948373|Other||Mean Difference (Net)|-0.2||||0.726|2-Sided|95.0|-1.3|0.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 6||
1605666|NCT02683785|2948373|Other||Mean Difference (Net)|-0.6||||0.298|2-Sided|95.0|-1.8|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 4||
1605667|NCT02683785|2948373|Other||Mean Difference (Net)|-0.4||||0.457|2-Sided|95.0|-1.3|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 2||
1605668|NCT02683785|2948373|Other||Mean Difference (Net)|-0.2||||0.587|2-Sided|95.0|-1.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Stiffness component, Week 1||
1605669|NCT02683785|2948373|Other||Mean Difference (Net)|-4.7||||0.082|2-Sided|95.0|-10.1|0.6||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 12||
1605670|NCT02683785|2948373|Other||Mean Difference (Net)|-5.5||||0.041|2-Sided|95.0|-10.8|-0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 10||
1605671|NCT02683785|2948373|Other||Mean Difference (Net)|-3.8||||0.176|2-Sided|95.0|-9.4|1.8||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 8||
1605672|NCT02683785|2948373|Other||Mean Difference (Net)|-1.0||||0.695|2-Sided|95.0|-5.9|4.0||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 6||
1605673|NCT02683785|2948373|Other||Mean Difference (Net)|-3.7||||0.113|2-Sided|95.0|-8.4|0.9||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component Week 4||
1605674|NCT02683785|2948373|Other||Mean Difference (Net)|-2.0||||0.282|2-Sided|95.0|-5.6|1.7||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||For Pain component, Week 2||
1605675|NCT02683785|2948373|Other||Mean Difference (Net)|-2.8||||0.061|2-Sided|95.0|-5.6|0.1||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||For Pain component, Week 1||
1605676|NCT02683785|2948378|Other||Mean Difference (Net)|-1.01||||0.098|2-Sided|95.0|-2.22|0.2||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented.||
1605677|NCT02683785|2948378|Other||Mean Difference (Net)|-0.98||||0.092|2-Sided|95.0|-2.13|0.17||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented.||
1605678|NCT02683785|2948378|Other||Mean Difference (Net)|-0.94||||0.107|2-Sided|95.0|-2.08|0.21||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented.||
1605679|NCT02683785|2948378|Other||Mean Difference (Net)|-0.33||||0.494|2-Sided|95.0|-1.28|0.63||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented||
1605708|NCT02683746|2948387|Other||Mean Difference (Net)|0.25|||||2-Sided|95.0|-0.2|0.69|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 2 are presented.||
1605680|NCT02683785|2948378|Other||Mean Difference (Net)|-0.78||||0.067|2-Sided|95.0|-1.63|0.06||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented.||
1605681|NCT02683785|2948378|Other||Mean Difference (Net)|-0.6||||0.129|2-Sided|95.0|-1.38|0.18||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 3 is presented||
1605682|NCT02683785|2948378|Other||Mean Difference (Net)|-0.27||||0.426|2-Sided|95.0|-0.96|0.41||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented||
1605683|NCT02683785|2948378|Other||Mean Difference (Net)|-0.45||||0.082|2-Sided|95.0|-0.97|0.06||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented.||
1605684|NCT02683785|2948379|Other||Mean Difference (Net)|-0.89||||0.132|2-Sided|95.0|-2.06|0.28||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 12 is presented.||
1605685|NCT02683785|2948379|Other||Mean Difference (Net)|-0.9||||0.103|2-Sided|95.0|-2.0|0.19||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 10 is presented||
1605686|NCT02683785|2948379|Other||Mean Difference (Net)|-0.83||||0.139|2-Sided|95.0|-1.93|0.28||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 8 is presented||
1605687|NCT02683785|2948379|Other||Mean Difference (Net)|-0.36||||0.442|2-Sided|95.0|-1.31|0.58||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented||
1605688|NCT02683785|2948379|Other||Mean Difference (Net)|-0.74||||0.085|2-Sided|95.0|-1.59|0.11||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 4 is presented||
1605689|NCT02683785|2948379|Other||Mean Difference (Net)|-0.5||||0.22|2-Sided|95.0|-1.31|0.31||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 3 is presented||
1605690|NCT02683785|2948379|Other||Mean Difference (Net)|-0.38||||0.257|2-Sided|95.0|-1.05|0.29||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 2 is presented||
1605691|NCT02683785|2948379|Other||Mean Difference (Net)|-0.46||||0.046|2-Sided|95.0|-0.9|-0.01||MMRM model with fixed effects of Baseline Value, Treatment Group, Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used. p-value corresponds to the difference over placebo measure and confidence interval.|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 1 is presented||
1605692|NCT02683785|2948380|Other||Mean Difference (Net)|-0.36||||0.442|2-Sided|95.0|-1.31|0.58||MMRM model with fixed effects of Baseline Value,Treatment Group,Visit and Treatment Group by Visit Interaction was used. Unstructured covariance structure was used.p-value corresponds to the difference over placebo measure and confidence interval|Mixed Model Repeated Measures Analysis||Difference from placebo for Week 6 is presented.||
1605693|NCT02683772|2948385|Non-Inferiority|The method proposed for this analysis was a one-sided paired t-test using a significance level of 0.05 and a non-inferiority margin of 2 events/hour|Mean Difference (Final Values)|-4.45|Standard Deviation|17.23||0.0134|2-Sided||||||t-test, 1 sided||||
1605694|NCT02683746|2948387|Other||Mean Difference (Net)|-0.34|||||2-Sided|95.0|-0.83|0.14|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 26 are presented.||
1605695|NCT02683746|2948387|Other||Mean Difference (Net)|0.03|||||2-Sided|95.0|-0.47|0.53|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 20 are presented.||
1605696|NCT02683746|2948387|Other||Mean Difference (Net)|0.06|||||2-Sided|95.0|-0.41|0.54|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 16 are presented.||
1605697|NCT02683746|2948387|Other||Mean Difference (Net)|0.05|||||2-Sided|95.0|-0.47|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 13 are presented.||
1605698|NCT02683746|2948387|Other||Mean Difference (Net)|0.03|||||2-Sided|95.0|-0.41|0.46|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 12 are presented.||
1605699|NCT02683746|2948387|Other||Mean Difference (Net)|0.11|||||2-Sided|95.0|-0.34|0.56|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 11 are presented.||
1605700|NCT02683746|2948387|Other||Mean Difference (Net)|0.15|||||2-Sided|95.0|-0.28|0.57|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 10 are presented.||
1605709|NCT02683746|2948387|Other||Mean Difference (Net)|0.25|||||2-Sided|95.0|-0.15|0.65|||||Difference in FPG levels between albiglutide liquid and lyophilized product at Week 1 are presented.||
1605710|NCT02683746|2948388|Other||Mean Difference (Net)|0.01|||<|0.0001|2-Sided|95.0|-0.17|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 26 are presented.||
1605711|NCT02683746|2948388|Other||Mean Difference (Net)|0.02|||<|0.0001|2-Sided|95.0|-0.15|0.19||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 20 are presented.||
1605712|NCT02683746|2948388|Other||Mean Difference (Net)|0.02|||<|0.0001|2-Sided|95.0|-0.16|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 16 are presented.||
1605713|NCT02683746|2948388|Other||Mean Difference (Net)|0.08|||<|0.0001|2-Sided|95.0|-0.08|0.24||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 12 are presented.||
1605714|NCT02683746|2948388|Other||Mean Difference (Net)|0.07|||<|0.0001|2-Sided|95.0|-0.07|0.2||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 8 are presented.||
1605715|NCT02683746|2948388|Other||Mean Difference (Net)|0.03|||<|0.0001|2-Sided|95.0|-0.07|0.13||Calculated P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||Difference in HbA1c levels between albiglutide liquid and lyophilized product at Week 4 are presented.||
1605716|NCT02683746|2948389|Other||Mean Difference (Net)|-0.34|||||2-Sided|95.0|-0.83|0.14|||||||
1605717|NCT02683746|2948397|Non-Inferiority|The primary hypothesis tested was that the liquid drug product would provide glycemic control non-inferior to the lyophilized drug product for a period of 26 weeks of treatment in participants with T2DM. Non-inferiority testing was performed at a one-sided alpha of 0.025 and non-inferiority margin of 0.4.|Mean Difference (Net)|0.06||||0.0002|2-Sided|95.0|-0.13|0.24||P-value from a one-sided t-test to test whether the difference of least square means (Albiglutide liquid - Albiglutide lyophilized) is equal to the pre-specified non-inferiority margin of 0.4%.|MMRM model||||
1605718|NCT02683577|2948408|Superiority or Other||Geometric LS mean ratio|3.32|||||2-Sided|90.0|2.3|4.8|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-inf) values for LP-778902.|
1605719|NCT02683577|2948408|Superiority or Other||Geometric LS mean ratio|2.26|||||2-Sided|90.0|1.33|3.82|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) on ln transformed AUC(0-inf) values for LP-778902.|
1605720|NCT02683577|2948409|Superiority or Other||Geometric LS mean ratio|3.52|||||2-Sided|90.0|2.45|5.03|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for LP-778902.|
1605721|NCT02683577|2948409|Superiority or Other||Geometric LS mean ratio|2.39|||||2-Sided|90.0|1.45|3.94|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for LP-778902.|
1605722|NCT02683577|2948410|Superiority or Other||Median difference|0.0|||=|0|2-Sided|90.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median differences between the hepatic impaired group (Test) versus the healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.|
1605723|NCT02683577|2948410|Superiority or Other||Median difference|0.0|||=|0|2-Sided|90.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median differences between the hepatic impaired group (Test) versus the healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.|
1605724|NCT02683577|2948411|Superiority or Other||Geometric LS mean ratio|2.0|||||2-Sided|90.0|1.51|2.66|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on Cmax values for LP-778902.|
1605725|NCT02683577|2948411|Superiority or Other||Geometric LS mean ratio|1.72|||||2-Sided|90.0|1.11|2.65|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for Cmax values for LP-778902.|
1605775|NCT02678286|2948646|Superiority|||||||0.004||||||Row 3 (SPID48)|t-test, 2 sided||||
1605776|NCT02678286|2948646|Superiority|||||||0.0434||||||Row 2 (SPID12)|t-test, 2 sided||||
1605777|NCT02678286|2948646|Superiority|||||||0.1841||||||Row 1 (SPID6)|t-test, 2 sided||||
1605726|NCT02683577|2948413|Superiority or Other||Geometric LS mean ratio|3.168|||||2-Sided|90.0|1.715|5.852|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) on AUC(0-tlast) values for telotristat ethyl.|
1605727|NCT02683577|2948413|Superiority or Other||Geometric LS mean ratio|2.294|||||2-Sided|90.0|1.144|4.598|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for AUC(0-tlast) values for telotristat ethyl.|
1605728|NCT02683577|2948414|Superiority or Other||Median difference|0.0|||=|0|2-Sided|90.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median difference between the moderate HI group (Test) versus healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.|
1605729|NCT02683577|2948414|Superiority or Other||Median difference|0.0|||=|0|2-Sided|90.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||The Tmax was analysed using a non-parametric analysis (Walsh averages and appropriate quantile of the Wilcoxon signed rank test statistic). The median difference between the mild HI group (Test) versus healthy control group (Reference) and the corresponding 90% CIs were calculated by Hodges-Lehmann estimation.|
1605730|NCT02683577|2948415|Superiority or Other||Geometric LS mean ratio|2.462|||||2-Sided|90.0|1.579|3.837|||||A repeated-measures ANOVA was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of moderate HI group (Test) versus healthy control group (Reference) for Cmax values for telotristat ethyl.|
1605731|NCT02683577|2948415|Superiority or Other||Geometric least square (LS) mean ratio|1.695|||||2-Sided|90.0|0.904|3.176|||||A repeated-measures analysis of variance (ANOVA) was performed using a linear mixed effects model, with hepatic function group as a fixed term. Geometric LS mean ratios were derived for each HI group (Test) versus healthy control group (Reference).|Comparison of mild HI group (Test) versus healthy control group (Reference) for Cmax values for telotristat ethyl.|
1605732|NCT02683109|2948427|Superiority or Other||Adjusted mean|-0.327|Standard Error of the Mean|0.536||0.542|2-Sided|95.0|-1.384|0.729|||ANCOVA|||The secondary analysis was conducted using an ANCOVA model including treatment as fixed categorical effect and baseline as continuous covariate.|
1605733|NCT02683109|2948428|Superiority or Other||Adjusted mean|0.006|Standard Error of the Mean|0.034||0.8648|2-Sided|95.0|-0.061|0.073|||ANCOVA|||The secondary analysis was conducted using an ANCOVA model including treatment as fixed categorical effect and baseline as continuous covariate.|
1605734|NCT02683109|2948429|Non-Inferiority or Equivalence|Non-inferiority of the Tio+Olo FDC versus the Tio/Olo free combination was tested at the one-sided α-level of 0.025 using a non-inferiority margin of 0.1 L.|Adjusted mean|0.024|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|-0.02|0.067|||ANCOVA|||The primary analysis was conducted using an Analysis of Covariance [ANCOVA] model including treatment as fixed categorical effect and baseline as continuous covariate.|
1605735|NCT02681094|2948490|Superiority||LS mean difference|-1.6|||<|0.0001|2-Sided|95.0|-2.11|-1.09|||Mixed Models Analysis||||
1605736|NCT02681094|2948491|Superiority||LS mean difference|-14.88|||<|0.0001|2-Sided|95.0|-20.85|-8.91|||Mixed Models Analysis||||
1605737|NCT02681094|2948491|Superiority||LS mean difference|-7.58|||<|0.0135|2-Sided|95.0|-13.59|-1.57|||Mixed Models Analysis||||
1605738|NCT02681094|2948492|Superiority||Risk Difference (RD)|11.7||||0.0018|2-Sided|95.0|4.4|19.1|||Method of Zhang, Tsiatis, and Davidian||||
1605739|NCT02681094|2948492|Superiority||Risk Difference (RD)|19.8|||<|0.0001|2-Sided|95.0|12.7|26.9|||Method of Zhang, Tsiatis, and Davidian||||
1605740|NCT02681094|2948493|Superiority||LS mean difference|-0.34|||<|0.0001|2-Sided|95.0|-0.5|-0.19|||Mixed Models Analysis||||
1605741|NCT02681094|2948493|Superiority||LS mean difference|-0.4|||<|0.0001|2-Sided|95.0|-0.55|-0.24|||Mixed Models Analysis||||
1605742|NCT02680301|2948538|Equivalence|Wilcoxon sign- rank test values with ranks from change in cream efficacy ratings minus change in ointment efficacy ratings.||||||0.22|||||||Wilcoxon (Mann-Whitney)||||
1605743|NCT02679729|2948576|Superiority or Other||Slope|1.55|||||2-Sided|95.0|1.34|1.76||||||Statistical Analysis for Part A|
1605744|NCT02679729|2948577|Superiority or Other||Slope|1.2|||||2-Sided|95.0|0.905|1.49||||||Statistical Analysis for Part A|
1605745|NCT02679729|2948578|Superiority or Other||Slope|0.625|||||2-Sided|95.0|0.396|0.853||||||Statistical Analysis for Part A|
1605746|NCT02679573|2948582|Other|||||||0.5951||||||The log-rank test was used to compare the time to all-cause mortality between the 2 treatment groups.|Log Rank||||
1605747|NCT02679573|2948583|Non-Inferiority|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.5|||||2-Sided|95.0|-4.8|5.9||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ ‒0.125 Ha: Pd - Pm > ‒0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."|
1605778|NCT02678286|2948647|Superiority|||||||0.0145|||||||t-test, 2 sided||||
1605779|NCT02677896|2948659|Superiority||Cox hazard ratio|0.92||||0.2715|2-Sided|95.0|0.78|1.07|||Log Rank|||Time to Pain Progression Based on BPI-SF Treatment Comparison|
1605780|NCT02677896|2948660|Superiority||Cox hazard ratio|0.96||||0.6548|2-Sided|95.0|0.81|1.14|||Log Rank|||Time to Deterioration of QoL in FACT-P Treatment Comparison|
1605781|NCT02677896|2948661|Superiority||Cox hazard ratio|0.28|||<|0.0001|2-Sided|95.0|0.22|0.36|||Log Rank|||Time to Castration Resistance Treatment Comparison|
1605782|NCT02677896|2948662|Superiority||Cox hazard ratio|0.52||||0.0026|2-Sided|95.0|0.33|0.8|||Log Rank|||Time to SSE Treatment Comparison|
1605748|NCT02679573|2948584|Non-Inferiority|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.8|||||2-Sided|95.0|-3.0|4.6||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ ‒0.125 Ha: Pd - Pm > ‒0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."|
1605749|NCT02679573|2948585|Non-Inferiority|Used on a normal approximation approach (Miettinen and Nurminen's Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|0.8|||||2-Sided|95.0|-3.3|4.8||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ ‒0.125 Ha: Pd - Pm > ‒0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."|
1605750|NCT02679573|2948586|Non-Inferiority|Used on a normal approximation approach (Miettinen and Nurminen’s Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|9.7|||||2-Sided|95.0|3.0|16.3||||||"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd - Pm ≤ ‒0.125 Ha: Pd - Pm > ‒0.125~where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin - moxifloxacin) was presented, and the Miettinen-Nurminen test without stratification was used for the 2 sided 95% CI on the difference in response rate."|
1605751|NCT02679573|2948587|Non-Inferiority|Used on a normal approximation approach (Miettinen and Nurminen’s Likelihood Score Test), 860 subjects in the ITT population provided a 90% power to assess non-inferiority of delafloxacin vs. moxifloxacin based on the following assumptions: (1) a rate of ECR for moxifloxacin therapy and delafloxacin of 77% and 74%, respectively; (2) 1 sided type I error (α) of 0.025; and (3) a non-inferiority margin of 12.5%.|Difference in responder rates|-0.2|||||2-Sided|95.0|-4.4|4.1|||||Difference = Difference in responder rates (Delafloxacin treatment group minus Moxifloxacin treatment group). Confidence intervals are calculated using Miettinen and Nurminen method without stratification.|"The null (H0) and alternative (Ha) hypotheses to be tested to establish the noninferiority of delafloxacin were:~H0: Pd – Pm ≤ ‒0.125 Ha: Pd – Pm > ‒0.125 where Pd and Pm are the probabilities of the ECR for delafloxacin and moxifloxacin, respectively.~The treatment difference (delafloxacin – moxifloxacin) were presented, and the Miettinen-Nurminen test, without stratification, was used for the 2 sided 95% CI on the difference in response rate."|
1605752|NCT02678923|2948618|Superiority||LS mean difference|0.73||||0.0738|2-Sided|95.0|-0.07|1.52||Baseline parameter value as a covariate and treatment group as factor, adjusting for country and prior statin use.|ANCOVA||||
1605753|NCT02678676|2948619|Superiority or Other||Risk Ratio (RR)|0.98|||||2-Sided|95.0|0.83|1.16||||||Test for statistical difference between pioglitazone and placebo with respect to time of first occurrence of the primary composite outcome event.|
1605754|NCT02678676|2948620|Superiority or Other||Hazard Ratio (HR)|0.96||||0.3444|2-Sided|95.0|0.88|1.04||No adjustment to the p-value|Regression, Cox|||Test for statistical difference between pioglitazone and placebo with respect to time of first occurrence of the primary composite outcome event.|
1605755|NCT02678442|2948623|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1605756|NCT02678442|2948624|Superiority|||||||0.02|||||||t-test, 2 sided||||
1605757|NCT02678442|2948625|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1605758|NCT02678442|2948627|Superiority|||||||0.01|||||||t-test, 2 sided||||
1605759|NCT02678286|2948635|Superiority|||||||0.0027|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site|||
1605760|NCT02678286|2948636|Superiority|||||||0.0607|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site|||
1605761|NCT02678286|2948637|Superiority|||||||0.0788|||||||Cochran-Mantel-Haenszel||||
1605762|NCT02678286|2948638|Superiority|||||||0.1888|||||||Cochran-Mantel-Haenszel||||
1605763|NCT02678286|2948639|Superiority|||||||0.0178|||||||Cochran-Mantel-Haenszel||||
1605764|NCT02678286|2948640|Superiority|||||||0.389|||||||Cochran-Mantel-Haenszel||||
1605765|NCT02678286|2948641|Superiority|||||||0.5096|||||||Log Rank||||
1605766|NCT02678286|2948642|Superiority|||||||0.005|||||||Log Rank||||
1605767|NCT02678286|2948643|Superiority|||||||0.0027||||||Row 3 (Hour 0-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site|||
1605768|NCT02678286|2948643|Superiority|||||||0.0009||||||Row 2 (Hour 24-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site|||
1605769|NCT02678286|2948643|Superiority|||||||0.0275||||||Row 1 (Hour 0-24)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site|||
1605770|NCT02678286|2948644|Superiority|||||||0.4994||||||Row 3 (Hour 0-48)|Cochran-Mantel-Haenszel||||
1605771|NCT02678286|2948644|Superiority|||||||0.0014||||||Row 2 (Hour 24-48)|Cochran-Mantel-Haenszel||||
1605772|NCT02678286|2948644|Superiority|||||||0.6559||||||Row 1 (Hour 0-24)|Cochran-Mantel-Haenszel||||
1605773|NCT02678286|2948645|Superiority|||||||0.7572|||||||Log Rank||||
1605774|NCT02678286|2948646|Superiority|||||||0.0028||||||Row 4 (SPID24-48)|t-test, 2 sided||||
1605783|NCT02677896|2948663|Superiority||Cox hazard ratio|0.88||||0.2162|2-Sided|95.0|0.72|1.08||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Time to Deterioration of Urinary Symptoms Treatment Comparison|
1605784|NCT02677896|2948664|Superiority||Difference in rate|19.3|||<|0.0001|2-Sided|95.0|10.4|28.2||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Cochran-Mantel-Haenszel|||ORR Treatment Comparison|
1605785|NCT02677896|2948665|Superiority||Difference in rate|50.5|||<|0.0001|2-Sided|95.0|45.3|55.7||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Cochran-Mantel-Haenszel|||PSA Undetectable Rate Treatment Comparison|
1605786|NCT02677896|2948666|Superiority||Cox hazard ratio|0.28|||<|0.0001|2-Sided|95.0|0.2|0.4||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Time to Start of New Therapy Treatment Comparison|
1605787|NCT02677896|2948667|Superiority||Cox hazard ratio|0.19|||<|0.0001|2-Sided|95.0|0.13|0.26||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Time to PSA Progression Treatment Comparison|
1605788|NCT02677896|2948669|Superiority||Cox proportional hazards model|0.39|||<|0.0001|2-Sided|95.0|0.3|0.5|||Log Rank|||rPFS Treatment Comparision|
1605789|NCT02677896|2948670|Superiority||Cox hazard ratio|0.39|||<|0.0001|2-Sided|95.0|0.3|0.5||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|Log Rank||Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.|rPFS Treatment Comparison|
1605790|NCT02676882|2948720|Other|A one-way repeated measures ANOVA was used to examine the overall course of Group 2 participants’ MADRS scores. (F(6, 29)=5.16, p=0.001).||||||0.001||||||a priori threshold for statistical significance: p <0.05|ANOVA||||
1605791|NCT02676882|2948721|Other|A Chi Squared analysis was performed to determine how the rate of relapse in Group 1 (27.3%) compared to that of historical controls in the literature (67.7%). (Cohen, JAMA 2006)||||||0.005||||||A priori threshold for statistical significance: p<0.05|Chi-squared||||
1605792|NCT02675907|2948731|Superiority|||||||0.0046|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site|||
1605793|NCT02675907|2948732|Superiority|||||||0.107|||||||Cochran-Mantel-Haenszel|P-value was derived from comparisons between N1539 and Placebo via General Association of CMH Test controlling for investigational site|||
1605794|NCT02675907|2948733|Superiority|||||||0.043|||||||Cochran-Mantel-Haenszel||||
1605795|NCT02675907|2948734|Superiority|||||||0.0781|||||||Cochran-Mantel-Haenszel||||
1605796|NCT02675907|2948735|Superiority|||||||0.0107|||||||Cochran-Mantel-Haenszel||||
1605797|NCT02675907|2948736|Superiority|||||||0.0451|||||||Cochran-Mantel-Haenszel||||
1605798|NCT02675907|2948737|Superiority|||||||0.1048|||||||Log Rank||||
1605799|NCT02675907|2948738|Superiority|||||||0.1228|||||||Log Rank||||
1605800|NCT02675907|2948739|Superiority||||||<|0.05||||||Row 3 (Hour 0-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site|||
1605801|NCT02675907|2948739|Superiority||||||<|0.05||||||Row 2 (Hour 24-48)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site|||
1605802|NCT02675907|2948739|Superiority||||||<|0.05||||||Row 1 (Hour 0-24)|ANCOVA|P-values were derived from ANCOVA models with fixed effects of treatment, baseline PI score, and investigational site|||
1605803|NCT02675907|2948740|Superiority||||||<|0.01||||||Row 3 (Hour 0-48)|Cochran-Mantel-Haenszel||||
1605804|NCT02675907|2948740|Superiority||||||<|0.01||||||Row 2 (Hour 24-48)|Cochran-Mantel-Haenszel||||
1605805|NCT02675907|2948740|Superiority||||||<|0.001||||||Row 1 (Hour 0-24)|Cochran-Mantel-Haenszel||||
1605806|NCT02675907|2948741|Superiority|||||||0.0076|||||||Log Rank||||
1605807|NCT02675907|2948742|Superiority||||||<|0.01||||||Row 5 (SPID24-48)|t-test, 2 sided||||
1605808|NCT02675907|2948742|Superiority||||||<|0.01||||||Row 4 (SPID12-48)|t-test, 2 sided||||
1605809|NCT02675907|2948742|Superiority||||||<|0.01||||||Row 3 (SPID24)|t-test, 2 sided||||
1605810|NCT02675907|2948742|Superiority||||||<|0.01||||||Row 2 (SPID12)|t-test, 2 sided||||
1605811|NCT02675907|2948742|Superiority||||||<|0.05||||||Row 1 (SPID6)|t-test, 2 sided||||
1605812|NCT02675907|2948743|Superiority|||||||0.0034|||||||t-test, 2 sided||||
1605813|NCT02675426|2948757|Superiority||Response Rate Difference|19.7|||<|0.001|2-Sided|95.0|12.7|26.7||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use|Response Rate Difference = Upadacitinib - Placebo||
1605814|NCT02675426|2948757|Superiority||Response Rate Difference|13.6|||<|0.001|2-Sided|95.0|7.0|20.2||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo||
1605815|NCT02675426|2948758|Superiority||Response Rate Difference|20.6|||<|0.001|2-Sided|95.0|14.0|27.2||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo||
1605816|NCT02675426|2948758|Superiority||Response Rate Difference|14.9|||<|0.001|2-Sided|95.0|8.7|21.1||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo||
1605817|NCT02675426|2948759|Superiority||Response Rate Difference|28.4|||<|0.001|2-Sided|95.0|20.4|36.5||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo||
1605818|NCT02675426|2948759|Superiority||Response Rate Difference|23.1|||<|0.001|2-Sided|95.0|15.1|31.0||Unadjusted p-value|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo||
1605819|NCT02675426|2948760|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.78|||<|0.001|2-Sided|95.0|3.12|6.44||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo||
1605820|NCT02675426|2948760|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.95|||<|0.001|2-Sided|95.0|3.31|6.6||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo||
1605821|NCT02675426|2948761|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Treatment Difference|-50.86|||<|0.001|2-Sided|95.0|-78.19|-23.53||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo||
1605822|NCT02675426|2948761|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-51.01|||<|0.001|2-Sided|95.0|-78.14|-23.87||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo||
1605823|NCT02675426|2948762|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|23.0|||<|0.001|2-Sided|95.0|14.7|31.3||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo||
1605824|NCT02675426|2948762|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|21.3|||<|0.001|2-Sided|95.0|13.0|29.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo||
1605825|NCT02675426|2948763|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|18.4|||<|0.001|2-Sided|95.0|11.2|25.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo||
1605826|NCT02675426|2948763|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|20.8|||<|0.001|2-Sided|95.0|13.6|28.1||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo||
1605827|NCT02675426|2948764|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.98|||<|0.001|2-Sided|95.0|3.54|6.42||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib – Placebo||
1605828|NCT02675426|2948764|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|4.55|||<|0.001|2-Sided|95.0|3.13|5.98||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and baseline value as covariate.|Treatment Difference = Upadacitinib – Placebo||
1605829|NCT02675426|2948765|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.28|||<|0.001|2-Sided|95.0|-0.38|-0.18||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and baseline value as covariates.|Treatment Difference = Upadacitinib – Placebo||
1605830|NCT02675426|2948765|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-0.33|||<|0.001|2-Sided|95.0|-0.43|-0.24||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and baseline value as covariates.|Treatment Difference = Upadacitinib – Placebo||
1605831|NCT02675426|2948766|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.32|||<|0.001|2-Sided|95.0|-1.56|-1.08||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and baseline value as covariates.|Treatment Difference = Upadacitinib – Placebo||
1605832|NCT02675426|2948766|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|LS Mean Difference|-1.18|||<|0.001|2-Sided|95.0|-1.42|-0.94||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|ANCOVA|ANCOVA model with treatment, prior bDMARD use and baseline value as covariates.|Treatment Difference = Upadacitinib – Placebo||
1605833|NCT02675426|2948767|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|30.8|||<|0.001|2-Sided|95.0|22.5|39.0||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib - Placebo||
1605834|NCT02675426|2948767|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|31.2|||<|0.001|2-Sided|95.0|23.0|39.5||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib – Placebo||
1605835|NCT02675426|2948768|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|30.5|||<|0.001|2-Sided|95.0|21.6|39.4||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib – Placebo||
1605836|NCT02675426|2948768|Superiority|The overall type I error rate of the primary and ranked key secondary endpoints for the two doses was controlled using a graphical multiple testing procedure.|Response Rate Difference|28.1|||<|0.001|2-Sided|95.0|19.1|37.0||The adjusted p-value under multiplicity control is reported, with significance achieved if the adjusted p-value is less than 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological disease-modifying anti-rheumatoid drug use.|Response Rate Difference = Upadacitinib – Placebo||
1605837|NCT02675231|2948770|Superiority||LS Mean Difference|-1.02|Standard Error of the Mean|2.1||0.62|2-Sided||||||MMRM Model||||
1605838|NCT02675231|2948770|Superiority||LS Mean Difference|1.22|Standard Error of the Mean|2.02||0.546|2-Sided||||||MMRM Model||||
1605839|NCT02675231|2948771|Superiority||LS Mean Difference|0.03|Standard Error of the Mean|0.02||0.275|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model||||
1605840|NCT02675231|2948771|Superiority||LS Mean Difference|0.05|Standard Error of the Mean|0.02||0.033|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model||||
1605841|NCT02675231|2948772|Superiority||LS Mean Difference|4.0|Standard Error of the Mean|3.0||0.18|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Symptom scale: Financial difficulties|
1605842|NCT02675231|2948772|Superiority||LS Mean Difference|19.3|Standard Error of the Mean|3.2|<|0.001|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Symptom scale: Diarrhoea|
1605843|NCT02675231|2948772|Superiority||LS Mean Difference|-2.9|Standard Error of the Mean|2.7|<|0.285|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Symptom scale: Constipation|
1605844|NCT02675231|2948772|Superiority||LS Mean Difference|3.9|Standard Error of the Mean|3.4|<|0.262|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Symptom scale: Appetite loss|
1605845|NCT02675231|2948772|Superiority||LS Mean Difference|-6.4|Standard Error of the Mean|3.1|<|0.041|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Symptom scale: Insomnia|
1605846|NCT02675231|2948772|Superiority||LS Mean Difference|-3.1|Standard Error of the Mean|2.8|<|0.276|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Symptom scale: Dyspnoea|
1605847|NCT02675231|2948772|Superiority||LS Mean Difference|-6.8|Standard Error of the Mean|3.0|<|0.026|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Symptom scale: Pain|
1605848|NCT02675231|2948772|Superiority||LS Mean Difference|4.1|Standard Error of the Mean|2.0|<|0.043|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Symptom scale: Nausea and vomiting|
1605849|NCT02675231|2948772|Superiority||LS Mean Difference|-2.9|Standard Error of the Mean|2.8|<|0.308|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Symptom scale: Fatigue|
1607169|NCT02634073|2952054|Superiority or Other||Ratio|0.557|||||2-Sided|90.0|0.518|0.599|||||AUC (0-24) comparision||
1605850|NCT02675231|2948772|Superiority||LS Mean Difference|1.5|Standard Error of the Mean|2.7|<|0.578|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Functional scale: Social functioning|
1605851|NCT02675231|2948772|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|2.1|<|0.935|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Functional scale: Cognitive functioning|
1605852|NCT02675231|2948772|Superiority||LS Mean Difference|1.3|Standard Error of the Mean|2.5|<|0.591|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Functional scale: Emotional functioning|
1605853|NCT02675231|2948772|Superiority||LS Mean Difference|5.5|Standard Error of the Mean|3.3|<|0.095|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Functional scale: Role functioning|
1605854|NCT02675231|2948772|Superiority||LS Mean Difference|3.4|Standard Error of the Mean|2.3|<|0.141|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Functional scales: Physical functioning|
1605855|NCT02675231|2948772|Superiority||Least Square (LS) Mean Difference|-1.0|Standard Error of the Mean|2.4|<|0.689|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model|||Global health status|
1605856|NCT02675231|2948773|Superiority||Mean Difference (Final Values)|-0.31||||0.232|2-Sided|||||p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.|MMRM Model||||
1605857|NCT02675231|2948779|Superiority|The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.||||||0.7695|||||||Log Rank|Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) >3) and status of disease(measurable vs non-measurable).||PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.|
1605858|NCT02675231|2948779|Superiority|The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.||||||0.0506|||||||Log Rank|Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) >3) and status of disease(measurable vs non-measurable).||PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.|
1605859|NCT02674854|2948780|Superiority||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. latanoprost|||
1605860|NCT02674854|2948780|Superiority||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. netarsudil|||
1605861|NCT02674334|2948807|Superiority or Other||Mean Difference (Net)|1.16|Standard Error of the Mean|0.83||0.165|2-Sided|95.0|-0.49|2.82||P-values were not adjusted for multiple inferences|ANOVA|Continuous responses were tested using RCB ANOVA.|||
1605862|NCT02673918|2948828|Equivalence|Differences (the number of participants in each of the three categories) between baseline and follow-up was calculated using a Wilcoxon signed-rank test. This was a feasibility test and no power calculation was performed.||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1605863|NCT02673918|2948829|Equivalence|Differences (the number of participants in each of the three categories) between baseline and follow-up was calculated using a Wilcoxon signed-rank test. This was a feasibility test and no power calculation was performed.||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1605864|NCT02673619|2948858|Other||Percentage Difference|7.5|||||2-Sided|90.0|-27.7|42.3|||||||
1605865|NCT02673619|2948858|Other||Percentage Difference|16.2|||||2-Sided|90.0|-32.0|59.7|||||||
1605866|NCT02673619|2948862|Other||Percentage Difference|18.0|||||2-Sided|90.0|-18.8|52.1|||||||
1605867|NCT02673619|2948862|Other||Percentage Difference|-16.2|||||2-Sided|90.0|-59.7|32.0|||||||
1605868|NCT02673619|2948863|Other||Percentage difference|25.5|||||2-Sided|90.0|-10.2|59.2|||||||
1605869|NCT02673619|2948863|Other||Percentage difference|25.0|||||2-Sided|90.0|-21.1|75.1|||||||
1605870|NCT02673541|2948869|Other|||||||1|||||||Fisher Exact||||
1605871|NCT02673515|2948872|Other|||||||0.797|||||||t-test, 2 sided|||Comparison of changes from baseline to 4 weeks between groups was tested with student´s t-test or Mann Whitney-U-Test|
1605872|NCT02672852|2948895|Other||Adjusted percentage difference|33.7|||<|0.001|2-Sided|95.0|23.2|44.2|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).|
1605873|NCT02672852|2948896|Other||Adjusted percentage difference|33.1|||<|0.001|2-Sided|95.0|24.0|42.2|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).|
1605874|NCT02672852|2948897|Other||Adjusted percentage difference|21.2|||<|0.001|2-Sided|95.0|13.7|28.7|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).|
1605875|NCT02672852|2948898|Other||Adjusted percentage difference|73.9|||<|0.001|2-Sided|95.0|66.0|81.9|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).|
1605876|NCT02672852|2948899|Other||Adjusted percentage difference|62.1|||<|0.001|2-Sided|95.0|56.4|67.9|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).|
1605877|NCT02672852|2948900|Other||Adjusted percentage difference|44.8|||<|0.001|2-Sided|95.0|39.5|50.0|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).|
1605878|NCT02672852|2948901|Other||Adjusted percentage difference|45.5|||<|0.001|2-Sided|95.0|40.3|50.8|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).|
1605879|NCT02672852|2948902|Other||Adjusted percentage difference|80.6|||<|0.001|2-Sided|95.0|74.5|86.6|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).|
1605880|NCT02672852|2948903|Other||Adjusted percentage difference|25.9|||<|0.001|2-Sided|95.0|17.3|34.6|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).|
1605881|NCT02672852|2948904|Other||Adjusted percentage difference|76.5|||<|0.001|2-Sided|95.0|70.4|82.5|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the CMH test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).|
1605882|NCT02672852|2948905|Other||Adjusted percentage difference|70.8|||<|0.001|2-Sided|95.0|65.7|76.0|||Cochran-Mantel-Haenszel|||Across strata, P value was calculated from the Cochran-Mantel-Haenszel (CMH) test adjusted for strata. Within each stratum, P value was calculated based on the chi-square test (or Fisher's exact test if ≥25% of the cells had expected cell count <5).|
1605883|NCT02672553|2948932|Superiority||Median Difference (Final Values)|-10.5||||0.2077|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1605884|NCT02672553|2948933|Superiority||Median Difference (Final Values)|-12.5|||<|0.0001|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1605885|NCT02672514|2948934|Superiority or Other|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected 48 hours after cardiopulmonary bypass.|
1605886|NCT02672514|2948934|Superiority or Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected four hours after cardiopulmonary bypass.|
1605887|NCT02672514|2948934|Superiority or Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected one hour after cardiopulmonary bypass.|
1605888|NCT02672514|2948934|Superiority or Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected on arrival of intensive care unit.|
1605889|NCT02672514|2948934|Superiority or Other|||||||0.118|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.|
1605890|NCT02672514|2948934|Superiority or Other|||||||0.463|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 72 hours after operation.|
1605891|NCT02672514|2948934|Superiority or Other|||||||0.796|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 48 hours after operation.|
1605892|NCT02672514|2948934|Superiority or Other|||||||0.221|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 24 hours after operation.|
1605893|NCT02672514|2948934|Superiority or Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected on arrival of intensive care unit.|
1605894|NCT02672514|2948934|Superiority or Other|||||||0.211|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.|
1605895|NCT02672514|2948934|Superiority or Other|||||||0.308|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups 72 hours after cardiopulmonary bypass.|
1605919|NCT02670811|2949088|Superiority or Other (legacy)||||||<|0.05||||||The primary outcome, systolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.|t-test, 2 sided||||
1605920|NCT02670629|2949091|Superiority or Other (legacy)|||||||0.003|||||||Chi-squared||||
1605896|NCT02672514|2948934|Superiority or Other|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. These blood samples were collected 48 hours after cardiopulmonary Bypass.|
1605897|NCT02672514|2948934|Superiority or Other|||||||0.282|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples from both groups were collected 24 hours after Operation.|
1605898|NCT02672514|2948934|Superiority or Other|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups on arrival of intensive care unit.|
1605899|NCT02672514|2948934|Superiority or Other|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The first blood samples from both groups were collected before cardiopulmonary bypass.|
1605900|NCT02672176|2948943|Equivalence|Information included in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1605901|NCT02672176|2948944|Equivalence|Information in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1605902|NCT02672176|2948945|Equivalence|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1605903|NCT02672176|2948946|Equivalence|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1605904|NCT02672176|2948947|Equivalence|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1605905|NCT02672176|2948948|Equivalence|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1605906|NCT02672176|2948949|Equivalence|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1605907|NCT02672176|2948950|Equivalence|See Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1605908|NCT02672176|2948951|Equivalence|Information included in Statistical Analysis||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1605909|NCT02671500|2948981|Superiority||||||<|0.001|||||||2-sided 1 sample exact binomial test|||A sample size of 260 participants in Region 1 would provide more than 80% power to detect an improvement of at least 6 percentage points in SVR12 rate from the performance goal of 85% by using a two-sided exact one-sample binomial test at the significance level of 0.05.|
1605910|NCT02670915|2949082|Superiority|Stepwise hierarchical testing procedure was applied: Step 3-Confirmatory secondary analysis: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Superiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below 0.|Treatment difference|-0.17|||=|0|2-Sided|95.0|-0.3|-0.03||p-values are from the 1-sided test for superiority evaluated at the 2.5% level.|multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.|
1605911|NCT02670915|2949082|Non-Inferiority|Stepwise hierarchical testing procedure was applied: Step 2-Confirmatory secondary analysis: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%.|Treatment difference|0.13|||<|0.001|2-Sided|95.0|-0.01|0.26||p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.|Multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value(s) imputed from the available information from the treatment the participant had been randomised to.|
1605912|NCT02670915|2949082|Non-Inferiority|Stepwise hierarchical testing procedure was applied: Step 1-Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog® both in combination with insulin degludec. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% confidence interval (CI) was below or equal to 0.4%.|Treatment difference|-0.17|||<|0.001|2-Sided|95.0|-0.3|-0.03||p-values are from the 1-sided test for non-inferiority evaluated at the 2.5% level.|Multiple imputation|Analyses were adjusted for region, strata (age), as factors, and baseline HbA1c as a covariate.||The primary analysis was implemented as a statistical model using multiple imputation where the participants without any available HbA1c measurements at scheduled visits had their change from baseline HbA1c value (s) imputed from the available information from the treatment the participant had been randomised to.|
1605913|NCT02670811|2949083|Superiority or Other (legacy)||||||<|0.05||||||The secondary outcome, triglycerides (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided||||
1605914|NCT02670811|2949084|Superiority or Other (legacy)||||||<|0.05||||||The secondary outcome, high density lipoproteins (mg/dL), between groups were analyzed using an independent sample student t test.|t-test, 2 sided||||
1605915|NCT02670811|2949085|Superiority or Other (legacy)||||||<|0.05||||||The secondary outcome, low density lipoprotein (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided||||
1605916|NCT02670811|2949086|Superiority or Other (legacy)||||||<|0.05||||||The secondary outcome, total cholesterol (mg/dL), between groups was analyzed using an independent sample student t test.|t-test, 2 sided||||
1605917|NCT02670811|2949087|Superiority or Other (legacy)||||||<|0.05||||||The secondary outcome, diastolic blood pressure (mmHg), between groups was analyzed using an independent sample student t test.|t-test, 2 sided||||
1605918|NCT02670811|2949088|Superiority or Other (legacy)||||||<|0.05||||||The primary outcome, systolic blood pressure (mmHg), was analyzed using a paired student t test.|t-test, 2 sided||||
1605948|NCT02669407|2949194|Other|Single group||||||0.001|||||||Tukey's method|||Baseline, 30 minutes|
1605921|NCT02670551|2949094|Superiority||Least Squares Mean Difference|-0.3||||0.0662|2-Sided|95.0|-0.5|0.0||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.|
1605922|NCT02670551|2949094|Superiority||Least Squares Mean Difference|-0.2||||0.0714|2-Sided|95.0|-0.5|0.0||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.|
1605923|NCT02670551|2949095|Superiority||Least Squares Mean Difference|-3.0||||0.0103|2-Sided|95.0|-5.1|-0.9||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.|
1605924|NCT02670551|2949095|Superiority||Least Squares Mean Difference|-2.5||||0.0331|2-Sided|95.0|-4.6|-0.4||MMRM analysis was used. Fixed factors: treatment group, pooled study center, visit, treatment-group-by-visit interaction. Covariates: Baseline value, baseline value-by-visit interaction. P-value was adjusted by matched parallel gatekeeping procedure.|Mixed Model Repeated Measures (MMRM)|||To control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6 for the primary and secondary efficacy parameters, the parallel gatekeeping procedure was implemented.|
1605925|NCT02670538|2949096|Superiority||LS Mean Difference|-0.2||||0.137|2-Sided|95.0|-0.4|0.1||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test||||
1605926|NCT02670538|2949096|Superiority||LS Mean Difference|-0.3||||0.0417|2-Sided|95.0|-0.6|-0.1||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test||||
1605927|NCT02670538|2949097|Superiority||LS Mean Difference|-1.8||||0.1051|2-Sided|95.0|-3.9|0.4||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test||||
1605928|NCT02670538|2949097|Superiority||Least Squares (LS) Mean Difference|-2.5||||0.0417|2-Sided|95.0|-4.6|-0.4||Adjusted p-value: adjustment was performed using matched parallel gatekeeping procedure to control the overall type I error rate for multiple comparisons of 2 active doses versus placebo at Week 6.|Contrast t-test||||
1605929|NCT02669862|2949143|Other|||||||0.0236||||||Not adjusted for multiple comparisons|Chi-squared||||
1605930|NCT02669862|2949143|Other|||||||0.9313||||||Not adjusted for multiple comparisons|Chi-squared|||PVal*- Chi-Square test used for calculating P-value by comparing Vehicle against each Active treatment group|
1605931|NCT02669862|2949145|Other|||||||0.009||||||PVal*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate. No adjustments for multiple comparisons.|ANCOVA|||"In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate."|
1605932|NCT02669862|2949145|Other|||||||0.555|||||||ANCOVA|Baseline values were the covariate||"In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.~PVal*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate."|
1605933|NCT02669849|2949154|Superiority||Least Squares (LS) Mean Difference|-0.69||||0.7519|2-Sided|95.0|-5.08|3.69|||Mixed-effects model for repeated measure||||
1605934|NCT02669433|2949180|Superiority||Mean Difference (Final Values)|0.07||||0.7008|2-Sided|95.0|-0.28|0.42||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active||
1605935|NCT02669433|2949180|Superiority||Mean Difference (Final Values)|0.15||||0.3953|2-Sided|95.0|-0.2|0.5||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active||
1605936|NCT02669433|2949181|Superiority||Mean Difference (Final Values)|0.67||||0.5274|2-Sided|95.0|-1.41|2.75||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active||
1605937|NCT02669433|2949181|Superiority||Mean Difference (Final Values)|-0.47||||0.6531|2-Sided|95.0|-2.55|1.6|||Mixed Models Analysis||Placebo - active||
1605938|NCT02669433|2949182|Superiority||Mean Difference (Final Values)|0.74||||0.6069|2-Sided|95.0|-2.08|3.55||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active||
1605939|NCT02669433|2949182|Superiority||Mean Difference (Final Values)|-2.01||||0.158|2-Sided|95.0|-4.8|0.79||The threshold for statistical significance was p=0.05|Mixed Models Analysis||Placebo - active||
1605940|NCT02669407|2949183|Other|Single group||||||0.045|||||||t-test, 2 sided|||Baseline, 24 hours|
1605941|NCT02669407|2949183|Other|Single group||||||0.606|||||||t-test, 2 sided|||Baseline, 90 minutes|
1605942|NCT02669407|2949185|Other|Single group||||||0.787|||||||t-test, 2 sided||||
1605943|NCT02669407|2949186|Other|Single group||||||0.061|||||||t-test, 2 sided||||
1605944|NCT02669407|2949188|Other|Single group||||||0.175|||||||t-test, 2 sided||||
1605945|NCT02669407|2949189|Other|Single group||||||0.586|||||||t-test, 2 sided|||Change in left ventricular end systolic dimension|
1605946|NCT02669407|2949189|Other|Single group||||||0.237|||||||t-test, 2 sided|||Change in left ventricular end diastolic dimension|
1605947|NCT02669407|2949193|Other|Single group||||||0.007|||||||Tukey's method|||baseline, 30 minutes|
1605953|NCT02669082|2949232|Other|||||||0.4125|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.|
1605954|NCT02669082|2949233|Other|||||||0.0534|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.|
1605955|NCT02669082|2949234|Other|||||||0.1969|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.|
1605956|NCT02669082|2949235|Other|||||||0.1706|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.|
1605957|NCT02669082|2949236|Other|||||||0.1358|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.|
1605958|NCT02669082|2949237|Other|||||||0.2955|||||||t-test, 2 sided|||Data at Baseline compared to the data at the end of the Treatment Period.|
1605959|NCT02668640|2949282|Other||||||=|0|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Activity Impairment Score at Week 24|
1605960|NCT02668640|2949282|Other||||||=|0|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Activity Impairment Score at Week 12|
1605961|NCT02668640|2949283|Other||||||=|0|||||||Wilcoxon signed-rank test|||Median Change from Baseline in Overall Work Impairment Score at Week 24|
1605962|NCT02668640|2949283|Other||||||=|0|||||||Wilcoxon signed-rank test|||Median Change from Baseline in WPAI Overall Work Impairment Score at Week 12|
1605963|NCT02668640|2949284|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median Change From Baseline in EQ-5D-3L Index Score at Week 24|
1605964|NCT02668640|2949284|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median Change From Baseline in EQ-5D-3L Index Score at Week 12|
1605965|NCT02668640|2949285|Other||||||=|0|||||||Wilcoxon signed-rank test|||Median change from baseline in MCS T-score at Week 24|
1605966|NCT02668640|2949285|Other||||||<|0.001|||||||Wilcoxon signed-rank test|||Median change from baseline in PCS T-score at Week 24|
1605967|NCT02668640|2949285|Other||||||=|0|||||||Wilcoxon signed-rank test|||Median change from baseline in MCS T-score at Week 12|
1605968|NCT02668640|2949285|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|||Median change from baseline in PCS T-score at Week 12|
1605969|NCT02668640|2949286|Other||||||=|0|||||||Wilcoxon signed-rank test||||
1605970|NCT02668640|2949287|Other||||||=|0|||||||Wilcoxon signed-rank test||||
1605971|NCT02668302|2949304|Superiority|||||||0.4709|||||||t-test, 2 sided|P-values from two-sample T-test with equal variance assumption|||
1605972|NCT02667912|2949314|Superiority|||||||0.37|||||||t-test, 2 sided||||
1605973|NCT02667912|2949315|Superiority|||||||0.969|||||||t-test, 2 sided||||
1605974|NCT02667912|2949316|Superiority|||||||0.238|||||||t-test, 2 sided||||
1605975|NCT02667912|2949317|Superiority|||||||0.217|||||||t-test, 2 sided||||
1605976|NCT02667912|2949318|Superiority|||||||0.324|||||||t-test, 2 sided||||
1605977|NCT02667912|2949319|Superiority|||||||0.204|||||||t-test, 2 sided||||
1605978|NCT02667912|2949320|Superiority|||||||0.054|||||||t-test, 2 sided||||
1605979|NCT02667912|2949321|Superiority|||||||0.04|||||||t-test, 2 sided||||
1605980|NCT02667912|2949322|Superiority|||||||0.66|||||||t-test, 2 sided||||
1605981|NCT02667912|2949323|Superiority|||||||0.59|||||||t-test, 2 sided||||
1605982|NCT02667912|2949324|Superiority|||||||0.66|||||||t-test, 2 sided||||
1605983|NCT02667912|2949325|Superiority|||||||0.49|||||||t-test, 2 sided||||
1605984|NCT02667912|2949326|Other|||||||0.304|||||||t-test, 2 sided||||
1605985|NCT02667912|2949327|Superiority|||||||0.041|||||||t-test, 2 sided||||
1605986|NCT02667912|2949328|Superiority|||||||0.213|||||||t-test, 2 sided||||
1605987|NCT02667912|2949331|Superiority||Mean Difference (Final Values)|7.8|Standard Error of the Mean|5.7||0.17|2-Sided|95.0|-3.7|19.3||The a priori threshold for statistical significance p<0.05|t-test, 2 sided||||
1605988|NCT02667912|2949332|Superiority||Mean Difference (Final Values)|-4.3||||0.27|2-Sided|95.0|-11.9|3.4|||t-test, 2 sided||||
1605989|NCT02667912|2949333|Other|||||||0.203|||||||t-test, 2 sided||||
1605990|NCT02667912|2949334|Superiority|||||||0.96|||||||t-test, 2 sided||||
1605991|NCT02667912|2949337|Superiority||Mean Difference (Final Values)|10.8||||0.045|2-Sided|95.0|0.3|21.4||The a priori threshold for statistical significance <0.05|t-test, 2 sided||||
1605992|NCT02667704|2949341|Superiority or Other||Ratio of geometric means in percentage|101.98|Standard Deviation|10.3|||2-Sided|90.0|94.909|109.57|||||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect|
1605993|NCT02667704|2949342|Superiority or Other||Ratio of geometric means in percentage|103.36|Standard Deviation|26.5|||2-Sided|90.0|86.134|124.025|||||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect|
1605994|NCT02667704|2949343|Superiority or Other||Ratio of geometric means in percentage|98.85|Standard Deviation|11.4|||2-Sided|90.0|91.32|107.01|||||Relative bioavailability was estimated by the ratio (T/R) of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient of variation.|Analysis of variance (ANOVA) model on the log scale including treatment as fixed effect and subject as a random effect|
1605995|NCT02666664|2949387|Superiority||||||<|0.001|||||||Chi-squared||||
1605996|NCT02666664|2949396|Superiority||Difference in LS mean|-13.6|Standard Error of the Mean|1.13|<|0.001|2-Sided|95.0|-15.8|-11.3|||ANCOVA||||
1605997|NCT02666664|2949397|Superiority||Location shift|-21.5|Standard Error of the Mean|2.8|<|0.001|2-Sided|95.0|-26.96|-16.0|||Wilcoxon (Mann-Whitney)||||
1605998|NCT02666664|2949398|Superiority||Difference in LS mean|-11.9|Standard Error of the Mean|0.85|<|0.001|2-Sided|95.0|-13.6|-10.2|||ANCOVA||||
1605999|NCT02666664|2949399|Superiority||Difference in LS mean|-11.1|Standard Error of the Mean|0.69|<|0.001|2-Sided|95.0|-12.5|-9.8|||ANCOVA||||
1606000|NCT02666664|2949400|Superiority||Difference in LS mean|-13.3|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-15.1|-11.6|||ANCOVA||||
1606001|NCT02666664|2949401|Superiority||Difference in LS mean|-16.1|Standard Error of the Mean|1.07|<|0.001|2-Sided|95.0|-18.2|-14.0|||ANCOVA||||
1606002|NCT02666664|2949403|Superiority||Difference in LS mean|-18.1|Standard Error of the Mean|1.01|<|0.001|2-Sided|95.0|-20.0|-16.1|||ANCOVA||||
1606003|NCT02666352|2949427|Other||Geometric least-squares mean ratio|1.41|||||2-Sided|90.0|1.06|1.87|||||||
1606004|NCT02666352|2949427|Other||Geometric least-squares mean ratio|1.2|||||2-Sided|90.0|0.9|1.6|||||||
1606005|NCT02666352|2949428|Other||Geometric least-squares mean ratio|0.68|||||2-Sided|90.0|0.4|1.14|||||||
1606006|NCT02666352|2949428|Other||Geometric least-squares mean ratio|0.77|||||2-Sided|90.0|0.45|1.3|||||||
1606007|NCT02666352|2949429|Other||Geometric least-squares mean ratio|0.9|||||2-Sided|90.0|0.6|1.34|||||||
1606008|NCT02666352|2949429|Other||Geometric least-squares mean ratio|0.89|||||2-Sided|90.0|0.6|1.33|||||||
1606009|NCT02666352|2949430|Other||Geometric least-squares mean ratio|1.58||||||90.0|1.17|2.14|||||||
1606010|NCT02666352|2949430|Other||Geometric least-squares mean ratio|1.24|||||2-Sided|90.0|0.91|1.68|||||||
1606011|NCT02666352|2949431|Other||Geometric least-squares mean ratio|1.36|||||2-Sided|90.0|1.0|1.85|||||||
1606012|NCT02666352|2949431|Other||Geometric least-squares mean ratio (GMR)|1.16|||||2-Sided|90.0|0.85|1.58|||||||
1606013|NCT02666352|2949434|Other||Geometric least-squares mean ratio|0.73|||||2-Sided|90.0|0.58|0.91|||||||
1606014|NCT02666352|2949434|Other||Geometric least-squares mean ratio|0.71|||||2-Sided|90.0|0.57|0.89|||||||
1606015|NCT02666352|2949435|Other||Geometric least-squares mean ratio|0.78|||||2-Sided|90.0|0.6|1.03|||||||
1606016|NCT02666352|2949435|Other||Geometric least-squares mean ratio|0.8|||||2-Sided|90.0|0.61|1.05|||||||
1606017|NCT02666352|2949436|Other||Geometric least-squares mean ratio|0.8|||||2-Sided|90.0|0.63|1.02|||||||
1606018|NCT02666352|2949436|Other||Geometric least-squares mean ratio|0.79|||||2-Sided|90.0|0.62|1.01|||||||
1606019|NCT02666352|2949437|Other||Geometric least-squares mean ratio|0.61||||||90.0|0.46|0.82|||||||
1606020|NCT02666352|2949437|Other||Geometric least-squares mean ratio|0.64|||||2-Sided|90.0|0.48|0.86|||||||
1606021|NCT02666352|2949438|Other||Geometric least-squares mean ratio|0.66|||||2-Sided|90.0|0.5|0.86|||||||
1606022|NCT02666352|2949438|Other||Geometric least-squares mean ratio|0.68|||||2-Sided|90.0|0.52|0.9|||||||
1606023|NCT02666352|2949442|Other||Geometric least-squares mean ratio|0.82|||||2-Sided|90.0|0.59|1.13|||||||
1606024|NCT02666352|2949442|Other||Geometric least-squares mean ratio|0.83|||||2-Sided|90.0|0.6|1.15|||||||
1606025|NCT02666352|2949443|Other||Geometric least-squares mean ratio|0.75|||||2-Sided|90.0|0.55|1.01|||||||
1606026|NCT02666352|2949443|Other||Geometric least-squares mean ratio|0.83|||||2-Sided|90.0|0.61|1.13|||||||
1606027|NCT02666352|2949444|Other||Geometric least-squares mean ratio|0.73|||||2-Sided|90.0|0.54|0.99|||||||
1606028|NCT02666352|2949444|Other||Geometric least-squares mean ratio|0.77|||||2-Sided|90.0|0.57|1.05|||||||
1606029|NCT02666352|2949445|Other||Geometric least-squares mean ratio|0.86||||||90.0|0.62|1.18|||||||
1606030|NCT02666352|2949445|Other||Geometric least-squares mean ratio|0.8|||||2-Sided|90.0|0.58|1.11|||||||
1606031|NCT02666352|2949446|Other||Geometric least-squares mean ratio|0.84|||||2-Sided|90.0|0.61|1.16|||||||
1606032|NCT02666352|2949446|Other||Geometric least-squares mean ratio|0.8|||||2-Sided|90.0|0.58|1.1|||||||
1606033|NCT02666352|2949452|Other||Geometric least-squares mean ratio|1.81|||||2-Sided|90.0|1.11|2.94|||||||
1606034|NCT02666352|2949452|Other||Geometric least-squares mean ratio|1.32|||||2-Sided|90.0|0.81|2.15|||||||
1606035|NCT02666352|2949453|Other||Geometric least-squares mean ratio|2.15|||||2-Sided|90.0|1.33|3.47|||||||
1606036|NCT02666352|2949453|Other||Geometric least-squares mean ratio|1.43|||||2-Sided|90.0|0.89|2.31|||||||
1606037|NCT02666352|2949454|Other||Geometric least-squares mean ratio|2.15||||||90.0|1.33|3.48|||||||
1606038|NCT02666352|2949454|Other||Geometric least-squares mean ratio|1.43|||||2-Sided|90.0|0.88|2.31|||||||
1606039|NCT02666352|2949455|Other||Geometric least-squares mean ratio|2.15|||||2-Sided|90.0|1.33|3.47|||||||
1606040|NCT02666352|2949455|Other||Geometric least-squares mean ratio|1.43|||||2-Sided|90.0|0.89|2.31|||||||
1606041|NCT02665468|2949472|Superiority|||||||0.01|||||||Chi-squared||||
1606042|NCT02665364|2949474|Superiority|||||||0.0396|||||||Pearson's Chi-squared||||
1606043|NCT02665364|2949475|Superiority|||||||0.0425|||||||Pearson's Chi-squared||||
1606044|NCT02665364|2949476|Superiority|||||||0.0097|||||||Student - Satterthwaite||||
1606045|NCT02665364|2949479|Superiority||Odds Ratio (OR)|1.83||||0.0762|2-Sided|95.0|0.938|3.574|||Regression, Logistic||||
1606046|NCT02665364|2949480|Superiority||Odds Ratio (OR)|1.81||||0.0796|2-Sided|95.0|0.932|3.524|||Regression, Logistic||||
1606047|NCT02665364|2949481|Superiority|||||||0.6169|||||||Student - Satterthwaite||||
1606048|NCT02665364|2949482|Superiority|||||||0.3258|||||||student - pooled||||
1606049|NCT02665364|2949483|Superiority|||||||0.9224|||||||student - pooled||||
1606050|NCT02665364|2949484|Superiority|||||||0.7946|||||||Wilcoxon (Mann-Whitney)|||Baseline to last available value between W24 and W36|
1606051|NCT02665364|2949485|Superiority|||||||0.0022|||||||Pearson's Chi-squared||||
1606052|NCT02665364|2949486|Superiority||Odds Ratio (OR)|1.18||||0.6243|2-Sided|95.0|0.602|2.329|||Regression, Logistic|||The SRI-4 response was analyzed using a logistic regression using the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.|
1606053|NCT02665364|2949487|Superiority||Odds Ratio (OR)|1.38||||0.34|2-Sided|95.0|0.716|2.657|||Regression, Logistic|||Descriptive statistics for the response to treatment according to BICLA at week 36 were presented by treatment group. The response to treatment according to BICLA was analyzed using a logistic regression with the response rate as dependent variable and treatment as independent variable, while adjusting for the minimization factors used for randomization.|
1607170|NCT02634073|2952054|Superiority or Other||Ratio|0.608|||||2-Sided|90.0|0.566|0.655|||||AUC (0-24) comparision||
1606054|NCT02665364|2949488|Superiority||arithmetic mean|-30.2802|Standard Error of the Mean|5.2588|<|0.0001|2-Sided|95.0|-40.6653|-19.8951|||ANCOVA|||The percent of change from baseline to last available value between W24 and W36 of treatment in the expression of IFN-induced genes was analyzed using an analysis of covariance (ANCOVA) model.|
1606055|NCT02664610|2949511|Superiority|||||||0.79|||||||t-test, 2 sided||||
1606056|NCT02664610|2949512|Superiority|||||||0.6|||||||t-test, 2 sided||||
1606057|NCT02664415|2949517|Superiority|||||||0.043|||||||Wilcoxon signed-rank test|||A comparison between baseline ATI and ART resumption within Placebo group.|
1606058|NCT02664415|2949517|Superiority|||||||0.002|||||||Wilcoxon signed-rank test|||A comparison between baseline ATI and ART resumption within VRC01 group.|
1606059|NCT02664415|2949517|Superiority|||||||0.961|||||||Wilcoxon (Mann-Whitney)|||A comparison between groups at ART resumption.|
1606060|NCT02664415|2949517|Superiority|||||||0.522|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups at baseline ATI.|
1606061|NCT02664415|2949518|Superiority|||||||0.5|||||||Wilcoxon signed-rank test|||Comparison between Baseline and ART resumption within Placebo arm.|
1606062|NCT02664415|2949518|Superiority|||||||0.221|||||||Wilcoxon signed-rank test|||Comparison between Baseline and ART resumption within VRC01 arm.|
1606063|NCT02664415|2949518|Superiority|||||||0.805|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at ART resumption|
1606064|NCT02664415|2949518|Superiority|||||||0.961|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at baseline ATI|
1606065|NCT02664415|2949521|Superiority|||||||0.22|||||||Wilcoxon signed-rank test|||A comparison of total HIV DNA at baeline ATI versus 6 months after ART resumption in the placebo arm|
1606066|NCT02664415|2949521|Superiority|||||||0.05|||||||Wilcoxon signed-rank test|||A comparison of total HIV DNA atbaseline ATI and 6 months after ART resumption within the VRC01 arm.|
1606067|NCT02664415|2949521|Superiority|||||||0.22||||||The p-value is adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the placebo arm.|
1606068|NCT02664415|2949521|Superiority|||||||0.002||||||The p-value is adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at ART resumption and 6 months after ART resumption within the VRC01 arm.|
1606069|NCT02664415|2949521|Superiority|||||||0.04||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at baseline ATI and ART resumption within the placebo arm.|
1606070|NCT02664415|2949521|Superiority|||||||0.15||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon signed-rank test|||A comparison of total HIV DNA at baseline ATI and ART resumption within the VRC01 arm.|
1606071|NCT02664415|2949522|Superiority|||||||0.693|||||||Wilcoxon (Mann-Whitney)||||
1606072|NCT02664415|2949524|Superiority|||||||0.031|||||||Log Rank||||
1606073|NCT02664415|2949525|Superiority|||||||0.588||||||This is p-value, comparing HIV-1 RNA levels at ART resumption between arms.|Wilcoxon (Mann-Whitney)||||
1606074|NCT02664415|2949525|Superiority|||||||0.027||||||This is a p-value, comparing HIV-1 RNA levels at first detection between arms.|Wilcoxon (Mann-Whitney)||||
1606075|NCT02664415|2949526|Superiority|||||||0.01|||||||Log Rank|||A comparison of time from ATI to HIV-1 RNA >= 1000 copies/mL between arms.|
1606076|NCT02664415|2949526|Superiority|||||||0.051|||||||Log Rank|||A comparison of time from ATI to HIV-1 RNA >= 20 copies/mL between arms.|
1606077|NCT02664415|2949527|Superiority|||||||1|||||||Fisher Exact|This is to confirm that the p-value from Fisher's Exact test was 1.000.|||
1606078|NCT02663232|2949699|Superiority or Other|||||||0.374|||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Vascular invasion (Without vascular invasion [referral category] vs With vascular invasion) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606079|NCT02663232|2949700|Superiority or Other|||||||0.949|||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of presence of regression (Without regression [referral category] vs With regression) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606080|NCT02663232|2949701|Superiority or Other|||||||0.615|||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Ulceration (no [referral category] vs yes) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606081|NCT02663232|2949702|Superiority or Other|||||||0.683|||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of Berslow thickness (≤1 mm [referral category] vs 1.01-2 mm vs 2.01-4 mm vs 4 mm) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606082|NCT02663232|2949703|Superiority or Other|||||||0.701|||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of method of fixation (buffered formalin [referral category] vs other) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606083|NCT02663232|2949704|Superiority or Other|||||||0.505|||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of tumor sample type (paraffin-embedded blocks [referral category] vs slides of paraffin blocks vs cytology slides) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606084|NCT02663232|2949705|Superiority or Other|||||||0.164|||||||Bivariate regression analysis|Bivariate regression analysis of anatomopathological risk factors for BRAF mutation||The association of tumor sample source (primary tumor [referral category] vs metastases vs relapses) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606085|NCT02663232|2949706|Superiority or Other|||||||0.291|||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of time since diagnosis of primary melanoma (continuous variable) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606167|NCT02661126|2949913|Other|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|2.03|||||2-Sided|90.0|1.38|2.97|||||||
1606086|NCT02663232|2949707|Superiority or Other|||||||0.313|||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of LDH (elevated [referral category] vs normal vs unknown) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606087|NCT02663232|2949708|Superiority or Other|||||||0.262|||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of primary tumor site (trunk [referral category] vs head and neck vs upper extremities vs lower extremities vs. visceral/mucosa) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606088|NCT02663232|2949709|Superiority or Other|||||||0.719|||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of sun exposure yes vs no with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606089|NCT02663232|2949710|Superiority or Other|||||||0.24|||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Family family history of melanoma (yes vs no) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606090|NCT02663232|2949711|Superiority or Other||Hazard Ratio (HR)|0.822||||0.653|2-Sided|95.0|0.351|1.928|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1c (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.|
1606091|NCT02663232|2949711|Superiority or Other||Hazard Ratio (HR)|0.466||||0.142|2-Sided|95.0|0.168|1.291|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1b (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.|
1606092|NCT02663232|2949711|Superiority or Other||Hazard Ratio (HR)|2.716||||0.028|2-Sided|95.0|1.115|6.616|||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation (n=184)||The association of Melanoma Stage M1a (using Melanoma Stage IIIC as referral category) with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.|
1606093|NCT02663232|2949711|Superiority or Other|||||||0.002|||||||Multivariate regression analysis|Multivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage IIIc with the risk of BRAF mutation (Yes/No) was assessed using multivariate regression analysis.|
1606094|NCT02663232|2949711|Superiority or Other|||||||0.196|||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage IIIC/M1a/M1b [referral category] vs M1c with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606095|NCT02663232|2949711|Superiority or Other|||||||0.001|||||||Bivariate regression analysis|Bivariate regression analysis of clinical risk factors for BRAF mutation||The association of Melanoma Stage (IIIC [referral category] versus (vs) M1a vs M1b vs M1c) with the risk of BRAF mutation (Yes/No) was assessed using bivariate regression analysis.|
1606096|NCT02662569|2949774|Superiority||LS Mean Treatment Difference|-24.01|Standard Error of the Mean|2.99|<|0.0001|2-Sided|95.0|-29.88|-18.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606097|NCT02662569|2949774|Superiority||LS Mean Treatment Difference|-27.18|Standard Error of the Mean|3.57|<|0.0001|2-Sided|95.0|-34.2|-20.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606098|NCT02662569|2949775|Superiority||LS Mean Treatment Difference|8.14|Standard Error of the Mean|1.58|<|0.0001|2-Sided|95.0|5.03|11.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606099|NCT02662569|2949775|Superiority||LS Mean Treatment Difference|5.88|Standard Error of the Mean|1.72|<|0.0003|2-Sided|95.0|2.49|9.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606100|NCT02662569|2949776|Superiority||LS Mean Treatment Difference|7.87|Standard Error of the Mean|1.41|<|0.0001|2-Sided|95.0|5.1|10.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606101|NCT02662569|2949776|Superiority||LS Mean Treatment Difference|6.34|Standard Error of the Mean|1.52|<|0.0003|2-Sided|95.0|3.36|9.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606102|NCT02662569|2949777|Superiority||LS Mean Treatment Difference|-12.31|Standard Error of the Mean|3.28|<|0.0001|2-Sided|95.0|-18.76|-5.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606103|NCT02662569|2949777|Superiority||LS Mean Treatment Difference|-16.41|Standard Error of the Mean|14.18|<|0.0002|2-Sided|95.0|-24.63|-8.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606104|NCT02662569|2949778|Superiority||LS Mean Treatment Difference|-15.63|Standard Error of the Mean|3.08|<|0.0001|2-Sided|95.0|-21.69|-9.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606105|NCT02662569|2949778|Superiority||LS Mean Treatment Difference|-18.02|Standard Error of the Mean|4.01|<|0.0002|2-Sided|95.0|-25.89|-10.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606106|NCT02662569|2949779|Superiority||LS Mean Treatment Difference|-45.32|Standard Error of the Mean|8.42|<|0.0001|2-Sided|95.0|-61.87|-28.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606107|NCT02662569|2949779|Superiority||LS Mean Treatment Difference|-62.46|Standard Error of the Mean|24.64|<|0.0001|2-Sided|95.0|-110.89|-14.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606108|NCT02662569|2949780|Superiority||LS Mean Treatment Difference|-50.77|Standard Error of the Mean|6.63|<|0.0001|2-Sided|95.0|-63.82|-37.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606109|NCT02662569|2949780|Superiority||LS Mean Treatment Difference|-55.52|Standard Error of the Mean|18.85|<|0.0001|2-Sided|95.0|-92.64|-18.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606110|NCT02662569|2949781|Superiority||Treatment Difference|68.8|||<|0.0001|2-Sided|95.0|60.6|75.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab QM - Placebo QM||
1606111|NCT02662569|2949781|Superiority||Treatment Difference|67.2|||<|0.0001|2-Sided|95.0|58.9|73.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606112|NCT02662569|2949782|Superiority||Treatment Difference|71.9|||<|0.0001|2-Sided|95.0|64.1|77.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab QM - Placebo QM||
1606113|NCT02662569|2949782|Superiority||Treatment Difference|68.4|||<|0.0001|2-Sided|95.0|60.4|74.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606114|NCT02662569|2949783|Superiority||LS Mean Treatment Difference|-51.7|Standard Error of the Mean|2.09|<|0.0001|2-Sided|95.0|-55.81|-47.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606115|NCT02662569|2949783|Superiority||LS Mean Treatment Difference|-58.21|Standard Error of the Mean|2.23|<|0.0001|2-Sided|95.0|-62.59|-53.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606116|NCT02662569|2949784|Superiority||LS Mean Treatment Difference|-56.73|Standard Error of the Mean|1.93|<|0.0001|2-Sided|95.0|-60.53|-52.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606117|NCT02662569|2949784|Superiority||LS Mean Treatment Difference|-58.2|Standard Error of the Mean|2.01|<|0.0001|2-Sided|95.0|-62.15|-54.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606118|NCT02662569|2949785|Superiority||LS Mean Treatment Difference|-40.56|Standard Error of the Mean|1.79|<|0.0001|2-Sided|95.0|-44.08|-37.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606119|NCT02662569|2949785|Superiority||LS Mean Treatment Difference|-43.94|Standard Error of the Mean|2.02|<|0.0001|2-Sided|95.0|-47.9|-39.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606168|NCT02661126|2949914|Other|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.85|||||2-Sided|90.0|1.2|2.87|||||||
1606169|NCT02661126|2949915|Other|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.72|||||2-Sided|90.0|1.15|2.56|||||||
1606120|NCT02662569|2949786|Superiority||LS Mean Treatment Difference|-43.67|Standard Error of the Mean|1.64|<|0.0001|2-Sided|95.0|-46.9|-40.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606121|NCT02662569|2949786|Superiority||LS Mean Treatment Difference|-44.09|Standard Error of the Mean|1.81|<|0.0001|2-Sided|95.0|-47.64|-40.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606122|NCT02662569|2949787|Superiority||LS Mean Treatment Difference|-35.89|Standard Error of the Mean|1.64|<|0.0001|2-Sided|95.0|-39.12|-32.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606123|NCT02662569|2949787|Superiority||LS Mean Treatment Difference|-42.22|Standard Error of the Mean|1.93|<|0.0001|2-Sided|95.0|-46.02|-38.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606124|NCT02662569|2949788|Superiority||LS Mean Treatment Difference|-39.5|Standard Error of the Mean|1.51|<|0.0001|2-Sided|95.0|-42.47|-36.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606125|NCT02662569|2949788|Superiority||LS Mean Treatment Difference|-41.53|Standard Error of the Mean|1.74|<|0.0001|2-Sided|95.0|-44.95|-38.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606126|NCT02662569|2949789|Superiority||LS Mean Treatment Difference|-49.42|Standard Error of the Mean|1.98|<|0.0001|2-Sided|95.0|-53.31|-45.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606127|NCT02662569|2949789|Superiority||LS Mean Treatment Difference|-57.06|Standard Error of the Mean|2.3|<|0.0001|2-Sided|95.0|-61.59|-52.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606128|NCT02662569|2949790|Superiority||LS Mean Treatment Difference|-54.85|Standard Error of the Mean|1.87|<|0.0001|2-Sided|95.0|-58.52|-51.18||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606129|NCT02662569|2949790|Superiority||LS Mean Treatment Difference|-56.93|Standard Error of the Mean|2.03|<|0.0001|2-Sided|95.0|-60.93|-52.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606130|NCT02662569|2949791|Superiority||LS Mean Treatment Difference|-54.22|Standard Error of the Mean|2.28|<|0.0001|2-Sided|95.0|-58.7|-49.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606131|NCT02662569|2949791|Superiority||LS Mean Treatment Difference|-61.64|Standard Error of the Mean|2.64|<|0.0001|2-Sided|95.0|-66.82|-56.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606132|NCT02662569|2949792|Superiority||LS Mean Treatment Difference|-59.4|Standard Error of the Mean|2.09|<|0.0001|2-Sided|95.0|-63.52|-55.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606133|NCT02662569|2949792|Superiority||LS Mean Treatment Difference|-60.9|Standard Error of the Mean|2.35|<|0.0001|2-Sided|95.0|-65.51|-56.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606134|NCT02662569|2949793|Superiority||LS Mean Treatment Difference|-58.8|Standard Error of the Mean|2.8|<|0.0001|2-Sided|95.0|-64.3|-53.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606170|NCT02661126|2949916|Other|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|2.02|||||2-Sided|90.0|1.5|2.74|||||||
1606171|NCT02661126|2949917|Other|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.94|||||2-Sided|90.0|1.39|2.72|||||||
1606135|NCT02662569|2949793|Superiority||LS Mean Treatment Difference|-63.6|Standard Error of the Mean|3.1|<|0.0001|2-Sided|95.0|-69.7|-57.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606136|NCT02662569|2949794|Superiority||LS Mean Treatment Difference|-63.1|Standard Error of the Mean|2.7|<|0.0001|2-Sided|95.0|-68.4|-57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606137|NCT02662569|2949794|Superiority||LS Mean Treatment Difference|-62.5|Standard Error of the Mean|2.9|<|0.0001|2-Sided|95.0|-68.2|-56.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606138|NCT02662569|2949795|Superiority||LS Mean Treatment Difference|-64.93|Standard Error of the Mean|2.56|<|0.0001|2-Sided|95.0|-69.97|-59.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606139|NCT02662569|2949795|Superiority||LS Mean Treatment Difference|-71.77|Standard Error of the Mean|2.97|<|0.0001|2-Sided|95.0|-77.61|-65.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606140|NCT02662569|2949796|Superiority||LS Mean Treatment Difference|-70.04|Standard Error of the Mean|2.35|<|0.0001|2-Sided|95.0|-74.67|-65.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab QM - Placebo QM||
1606141|NCT02662569|2949796|Superiority||LS Mean Treatment Difference|-70.29|Standard Error of the Mean|2.61|<|0.0001|2-Sided|95.0|-75.43|-65.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit|Treatment difference = Evolocumab Q2W - Placebo Q2W||
1606142|NCT02662036|2949814|Superiority|||||||0.38|||||||Mann Whitney U Test||||
1606143|NCT02662036|2949815|Superiority|||||||0.64|||||||Mann Whitney U Test||||
1606144|NCT02662036|2949816|Superiority|||||||0.2|||||||Mann Whitney U Test||||
1606145|NCT02662036|2949817|Superiority|||||||0.5|||||||Mann Whitney U Test|||Statistical analysis #3 is for total antiemetic use|
1606146|NCT02662036|2949817|Superiority|||||||0.62|||||||Mann Whitney U Test|||Statistical analysis #2 is for floor antiemetic use|
1606147|NCT02662036|2949817|Superiority|||||||0.28|||||||Mann Whitney U Test|||Statistical analysis #1 is for postoperative acute care unit antiemetic use|
1606148|NCT02662036|2949818|Superiority|||||||0.98|||||||Mann Whitney U Test|||Statistical analysis #4 is for total opioid use|
1606149|NCT02662036|2949818|Superiority|||||||0.69|||||||Mann Whitney U Test|||Statistical analysis #3 is for postoperative floor opioid use|
1606150|NCT02662036|2949818|Superiority|||||||0.38|||||||Mann Whitney U Test|||Statistical analysis #2 is for postoperative acute care unit opioid use|
1606151|NCT02662036|2949818|Superiority|||||||0.76|||||||Mann Whitney U Test|||Statistical analysis #1 is for intraoperative opioid use|
1606152|NCT02661126|2949889|Other|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.54|||||2-Sided|90.0|1.15|2.07|||||||
1606153|NCT02661126|2949890|Other|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.44|||||2-Sided|90.0|1.05|1.98|||||||
1606154|NCT02661126|2949891|Other|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.49|||||2-Sided|90.0|1.13|1.98|||||||
1606155|NCT02661126|2949892|Other|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.57|||||2-Sided|90.0|1.2|2.05|||||||
1606156|NCT02661126|2949893|Other|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.56|||||2-Sided|90.0|1.19|2.05|||||||
1606157|NCT02661126|2949898|Other|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.28|||||2-Sided|90.0|0.56|2.91|||||||
1606158|NCT02661126|2949899|Other|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.23|||||2-Sided|90.0|0.5|3.05|||||||
1606159|NCT02661126|2949900|Other|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.15|||||2-Sided|90.0|0.51|2.57|||||||
1606160|NCT02661126|2949901|Other|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.59|||||2-Sided|90.0|0.79|3.19|||||||
1606161|NCT02661126|2949902|Other|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.33|||||2-Sided|90.0|0.65|2.75|||||||
1606162|NCT02661126|2949905|Other|GMR of C24 in Moderate RI/Healthy Participants|GMR of C24 in Moderate RI/Healthy|1.94|||||2-Sided|90.0|1.47|2.57|||||||
1606163|NCT02661126|2949906|Other|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.7|||||2-Sided|90.0|1.29|2.24|||||||
1606164|NCT02661126|2949907|Other|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|1.96|||||2-Sided|90.0|1.54|2.48|||||||
1606165|NCT02661126|2949908|Other|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|1.97|||||2-Sided|90.0|1.48|2.63|||||||
1606166|NCT02661126|2949909|Other|GMR of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|1.91|||||2-Sided|90.0|1.44|2.53|||||||
1606172|NCT02661126|2949923|Other|GMR of Cmax in Moderate RI/Healthy Participants|GMR of Cmax in Moderate RI/Healthy|1.92|||||2-Sided|90.0|1.35|2.74|||||||
1606173|NCT02661126|2949924|Other|GMR of AUC0-24 in Moderate RI/Healthy Participants|GMR of AUC0-24 in Moderate RI/Healthy|2.02|||||2-Sided|90.0|1.39|2.92|||||||
1606174|NCT02661126|2949925|Other|GMR of AUC0-∞ in Moderate RI/Healthy Participants|GMR of AUC0-∞ in Moderate RI/Healthy|2.0|||||2-Sided|90.0|1.39|2.89|||||||
1606175|NCT02661126|2949926|Other|Geometric least-squares mean ratio (GMR) of AUC0-last in Moderate RI/Healthy Participants.|GMR of AUC0-last in Moderate RI/Healthy|2.02|||||2-Sided|90.0|1.4|2.92|||||||
1606176|NCT02660983|2949929|Superiority||Difference in LS means|-14.88||||0.0551|2-Sided|95.0|-30.1|0.33|||ANCOVA|||Part B|
1606177|NCT02660983|2949929|Superiority||Difference in LS means|-7.73||||0.2213|2-Sided|95.0|-20.13|4.68|||ANCOVA|||Part A|
1606178|NCT02660983|2949930|Superiority||Difference in LS means|0.65||||0.0396|2-Sided|95.0|0.03|1.26|||ANCOVA||||
1606179|NCT02660983|2949931|Superiority||Difference in LS means|-0.12||||0.257|2-Sided|95.0|-0.32|0.09|||ANCOVA||LS mean of Donepezil group - LS mean of Placebo (when the difference of LS mean scores were less than 0, considered as demonstrated hypothesis), analyzed with ANCOVA model with baseline (CIBIS) as covariate and treatment as main effect.||
1606180|NCT02660983|2949932|Superiority||Difference in least square (LS) means|-0.58||||0.3455|2-Sided|95.0|-1.79|0.63|||ANCOVA||||
1606181|NCT02660853|2949947|Superiority|||||||0.326|||||||t-test, 2 sided||||
1606182|NCT02660853|2949951|Superiority|||||||0.745|||||||t-test, 2 sided|||Baseline versus during exacerbation.|
1606183|NCT02660580|2949985|Equivalence|MSB11022 was considered equivalent to EU-Humira if the 95% stratified Newcombe Confidence Interval (CI) for the difference in percentage was included in the equivalence interval (-18, 18).|Percentage difference|-1.9|||||2-Sided|95.0|-7.82|4.07|||||||
1606184|NCT02660580|2950001|Equivalence|MSB11022 was considered equivalent to EU-Humira if the 95% CI for the treatment difference was included in the equivalence interval [-15%, 15%]).|Least Square (LS) Mean difference|0.88|||||2-Sided|95.0|-1.21|2.98|||||||
1606185|NCT02660242|2950002|Superiority|||||||0.26|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session|||
1606186|NCT02660242|2950003|Superiority|||||||0.24|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session|||
1606187|NCT02660242|2950004|Superiority|||||||0.63|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session|||
1606188|NCT02660242|2950005|Superiority|||||||0.84|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session|||
1606189|NCT02660242|2950006|Superiority|||||||0.67|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session|||
1606190|NCT02660242|2950007|Superiority|||||||0.69|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session|||
1606191|NCT02660242|2950008|Superiority|||||||0.16|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session|||
1606192|NCT02660242|2950009|Superiority|||||||0.43|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session|||
1606193|NCT02660242|2950010|Superiority|||||||0.99|||||||Mixed Models Analysis|Accounted for correlation due to cross-over design and adjusted for exercise session|||
1606194|NCT02660242|2950011|Superiority|||||||0.15|||||||Mixed Models Analysis|Adjusted for subject effect, exercise session, and baseline blood glucose|||
1606195|NCT02660242|2950012|Other|||||||0.99|||||||Mixed Models Analysis|Adjusted for subject effect, exercise session, and baseline blood glucose|||
1606196|NCT02660242|2950013|Superiority||||||<|0.001|||||||Mixed Models Analysis|Mixed model w/ repeated measures to account for correlation from cross-over design and multiple measures, adjusting for baseline glucose and period.||The mini-dose glucagon (MDG) condition was compared with each of the conditions. In the event that exercise was terminated early due to glucose <70 mg/dL and the participant was treated for hypoglycemia (or if participant was treated for hypoglycemia during early recovery [prior to the meal]), the nadir glucose value was carried forward through the end of early recovery.|
1606197|NCT02660112|2950019|Superiority|||||||0.336|||||||Wilcoxon (Mann-Whitney)||||
1606198|NCT02658240|2950082|Superiority|||||||0.584|||||||Wilcoxon (Mann-Whitney)||||
1606199|NCT02658240|2950083|Superiority|||||||0.149|||||||t-test, 2 sided||||
1606200|NCT02658240|2950084|Superiority|||||||0.05|||||||ANOVA||||
1606201|NCT02658240|2950085|Superiority|||||||0.05|||||||ANOVA|||The study was powered to detect a mean difference of 1.5 in pain scores in favor of patients undergoing SFICB procedure assuming a standard deviation of 2.5. With a two sided alpha level of 0.05, a total of 52 patients would be needed to have 80% power using a repeated measures ANOVA F test with 6 observations on each subject. Correlation on the repeat observations was assumed to be 0.5. Assuming a 14% loss to follow-up, 60 patients were enrolled at 1:1 ratio.|
1606202|NCT02658149|2950086|Other|||||||1|||||||t-test, 2 sided||||
1606203|NCT02658149|2950087|Other|||||||0.741|||||||t-test, 2 sided||||
1606204|NCT02658149|2950088|Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1606205|NCT02658149|2950089|Other|||||||0.204|||||||Wilcoxon (Mann-Whitney)||||
1606206|NCT02658149|2950090|Other|||||||0.036|||||||Wilcoxon (Mann-Whitney)||||
1606207|NCT02657928|2950102|Superiority|||||||0.9127|||||||Log Rank||||
1606208|NCT02657928|2950103|Superiority|||||||0.5004|||||||Log Rank||||
1606209|NCT02657915|2950112|Superiority||Mean Difference (Final Values)|-6.0|||=|0|2-Sided|95.0|-14.56|2.57|||ANCOVA||||
1606210|NCT02657629|2950122|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1606211|NCT02657408|2950127|Equivalence|No statistical hypothesis tested|Geometric mean ratio (%)|0.64|||||2-Sided|90.0|0.43|0.97||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.|
1606383|NCT02651688|2950563|Superiority|||||||0.022|||||||Wilcoxon rank-sum test||||
1606384|NCT02651688|2950564|Superiority|||||||1|||||||Wilcoxon rank-sum test||||
1606212|NCT02657408|2950128|Equivalence|No statistical hypothesis tested|Geometric mean ratio (%)|0.81|||||2-Sided|90.0|0.51|1.28||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.|
1606213|NCT02657408|2950129|Equivalence|No statistical hypothesis tested|Geometric mean ratio (%)|0.94|||||2-Sided|90.0|0.8|1.09||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.|
1606214|NCT02657408|2950130|Equivalence|No statistical hypothesis tested|Geometric mean ratio (%)|1.18|||||2-Sided|90.0|0.91|1.53||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.|
1606215|NCT02657408|2950131|Equivalence|No statistical hypothesis tested|Geometric mean ratio (%)|1.03|||||2-Sided|90.0|0.9|1.18||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.|
1606216|NCT02657408|2950132|Equivalence|No statistical hypothesis tested|Geometric mean ratio (%)|1.29|||||2-Sided|90.0|0.91|1.83||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.|
1606217|NCT02657408|2950133|Equivalence|No statistical hypothesis tested|Geometric mean ratio (%)|1.17|||||2-Sided|90.0|0.49|2.85||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.|
1606218|NCT02657408|2950134|Equivalence|No statistical hypothesis tested|Geometric mean ratio (%)|1.54|||||2-Sided|90.0|0.59|4.03||||||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.|
1606219|NCT02657408|2950135|Equivalence|No statistical hypothesis tested|Geometric mean ratio (%)|1.01|||||2-Sided|90.0|0.88|1.16||||||The statistical model used for the analysis was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.|
1606220|NCT02657408|2950136|Equivalence|confirmatory statistical hypothesis tested|Geometric mean ratio (%)|1.27||||0.3043|2-Sided|90.0|0.86|1.87|||ANOVA|||The statistical model used for the primary analysis of primary endpoints was an ANOVA model on the logarithmic scale. This model included the effect 'treatment'.|
1606221|NCT02656693|2950160|Superiority|||||||0.31|||||||Mixed Models Analysis||||
1606222|NCT02656693|2950161|Superiority|||||||0.34|||||||Mixed Models Analysis||||
1606223|NCT02656693|2950162|Superiority|||||||0.59|||||||Mixed Models Analysis||||
1606224|NCT02656693|2950163|Superiority|||||||0.64|||||||Mixed Models Analysis||||
1606225|NCT02656693|2950164|Superiority|||||||0.0001|||||||Mixed Models Analysis||||
1606226|NCT02656693|2950165|Superiority|||||||0.54|||||||Mixed Models Analysis||||
1606227|NCT02656693|2950166|Superiority|||||||0.34|||||||Mixed Models Analysis||||
1606228|NCT02656693|2950167|Superiority|||||||0.18|||||||Mixed Models Analysis||||
1606229|NCT02656693|2950168|Superiority|||||||0.34|||||||Mixed Models Analysis||||
1606230|NCT02656693|2950169|Superiority|||||||0.31|||||||Mixed Models Analysis||||
1606231|NCT02656693|2950170|Superiority|||||||0.15|||||||Mixed Models Analysis||||
1606232|NCT02656693|2950171|Superiority|||||||0.00017|||||||Mixed Models Analysis||||
1606233|NCT02656420|2950174|Superiority|To summarize first 12-hour SPMA levels over the study course by participant, the SPMA geometric mean (in the log scale) for each individual was calculated and used as the outcome. Treatment arms (placebo, fifth, half and full doses) were independent (categorical) variables in a linear regression model with placebo as the reference.|Mean Difference (Final Values)|63.2|||<|0.05|2-Sided|95.0|10.6|140.9|||Regression, Linear||This Estimation Parameter was based on the comparison between the full dose group and the placebo group.|All broccoli sprout arms were compared with the placebo arm.|
1606234|NCT02656420|2950175|Equivalence|Statistical significance of the treatment effect (p < 0.01) for the lower doses compared to the high dose as the reference.|Mean Difference (Final Values)|-1.73|Standard Error of the Mean|0.09|<|0.001|2-Sided|95.0|-1.89|-1.57||Using a linear mixed effects model with random intercepts and slope, SF level (in the log scale) was regressed on categorical treatment group (medium dose and low dose; high as the reference) as well as day (continuous variable).|Mixed Models Analysis|||The null hypothesis is that the urinary sulforaphane levels are equal across treatment arms. Sulforaphane metabolite levels were measured daily for 10 days in each arm.|
1606235|NCT02656329|2950184|Non-Inferiority|Non-inferiority of AdreView™ group over SoC group was demonstrated if upper bound of the 95% confidence interval (CI) for the hazard ratio (HR) (AdreView™ group / SoC) was equal to 1.20.|Hazard Ratio (HR)|1.047||||0.8459|2-Sided|95.0|0.295|3.719||Threshold for significance at 0.025 level.|Log Rank||AdreView™ vs. Standard of Care|Analysis was performed using the Cox proportional hazards model stratified by country, with method of treatment guidance (SoC vs AdreView™ group) as the only covariate.|
1606236|NCT02656173|2950212|Superiority||Least square mean difference|2.79|||<|0.001|2-Sided|95.0|1.13|4.44|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606237|NCT02656173|2950213|Superiority||Least square mean difference|-4.52|||<|0.001|2-Sided|95.0|-6.91|-2.13|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606238|NCT02656173|2950214|Superiority||Least square mean difference|-0.29||||0.009|2-Sided|95.0|-0.51|-0.07|||ANCOVA|||Subscale: Quality of Life (QoL) Item. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606239|NCT02656173|2950214|Superiority||Least square mean difference|-0.42||||0.103|2-Sided|95.0|-0.93|0.09|||ANCOVA|||Subscale: Voiding Subscale-2. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606240|NCT02656173|2950214|Superiority||Least square mean difference|-0.3||||0.167|2-Sided|95.0|-0.72|0.13|||ANCOVA|||Subscale: Voiding Subscale-1. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606241|NCT02656173|2950214|Superiority||Least square mean difference|-0.78|||<|0.001|2-Sided|95.0|-1.13|-0.43|||ANCOVA|||Subscale: Storage Subscale. Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606242|NCT02656173|2950215|Superiority||Least square mean difference|-1.19||||0.002|2-Sided|95.0|-1.94|-0.44|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606243|NCT02656173|2950216|Superiority||Least square mean difference|-0.18||||0.014|2-Sided|95.0|-0.32|-0.04|||ANCOVA|||Subscale: Urgency Incontinence. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606244|NCT02656173|2950216|Superiority||Least square mean difference|-0.26||||0.037|2-Sided|95.0|-0.5|-0.02|||ANCOVA|||Subscale: Urgency. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606245|NCT02656173|2950216|Superiority||Least square mean difference|-0.08||||0.174|2-Sided|95.0|-0.19|0.03|||ANCOVA|||Subscale: Nighttime Frequency. ANCOVA was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606246|NCT02656173|2950216|Superiority||Least square mean difference|-0.11||||0.006|2-Sided|95.0|-0.19|-0.03|||ANCOVA|||Subscale: Daytime Frequency. Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606247|NCT02656173|2950217|Superiority||Least square mean difference|-0.65||||0.001|2-Sided|95.0|-1.04|-0.26|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606248|NCT02656173|2950218|Superiority||Least square mean difference|12.08|||<|0.001|2-Sided|95.0|6.33|17.84|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606249|NCT02656173|2950219|Superiority||Least square mean difference|-0.03||||0.646|2-Sided|95.0|-0.18|0.11|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606250|NCT02656173|2950220|Superiority||Cochran-Mantel-Haenszel Statistics|0.09||||0.76|||||||Stratified Rank Analysis of Covariance|||Stratified Rank Analysis of Covariance (RANCOVA), including the rank score for change from Baseline to End of Treatment stratified by region as the dependent variable, treatment group and region as fixed factors and the rank score for baseline stratified by region as a covariate for FAS.|
1606251|NCT02656173|2950221|Superiority||Cochran-Mantel-Haenszel Statistics|1.75||||0.186|||||||Stratified Rank Analysis of Covariance|||Stratified Rank Analysis of Covariance (RANCOVA), including the rank score for change from Baseline to End of Treatment stratified by region as the dependent variable, treatment group and region as fixed factors and the rank score for baseline stratified by region as a covariate for FAS.|
1606252|NCT02656173|2950222|Superiority||least square mean difference|-0.28||||0.112|2-Sided|95.0|-0.63|0.07|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis including treatment group and region as fixed factors and baseline as a covariate.|
1606253|NCT02656173|2950223|Superiority||least square mean difference|-0.48|||<|0.001|2-Sided|95.0|-0.78|-0.17|||mixed model repeated measure|||Mixed Model Repeated Measure (MMRM) was used for analysis, which included the baseline as a covariate, treatment group, analysis visits and region as a fixed effect, subject as random effect and including interaction of [treatment group x visit] for FAS.|
1606254|NCT02656173|2950224|Superiority||least square mean difference|-0.52|||<|0.001|2-Sided|95.0|-0.82|-0.21|||ANCOVA|||Analysis of Covariance (ANCOVA) was used for analysis, including treatment group and region as fixed factors and baseline as a covariate.|
1606255|NCT02656160|2950225|Other|||||||0.42||||||P<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)||||
1606256|NCT02656160|2950226|Other|||||||0.322||||||P<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||Phasic activity|
1606257|NCT02656160|2950226|Other|||||||0.85||||||P<0.05 considered statistically significant|Wilcoxon (Mann-Whitney)|||tonic|
1606258|NCT02655887|2950244|Other|||||||0.001||||||p value is < 0.001|t-test, 2 sided||||
1606259|NCT02655887|2950245|Other|||||||0.001||||||this p value is < 0.001.|t-test, 2 sided|||"H0: The distribution at the 12-month follow-up remains unimproved compared to baseline.~Ha: The distribution shifts toward lower (less pain) classes."|
1606260|NCT02655887|2950246|Non-Inferiority|The primary safety endpoint was evaluated against the PG of 89% which was set at 10% (non-inferiority margin) below the literature-derived average freedom from MAE rate at 30 day of 99%. A one-side p-value is derived based on an exact binomial test. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%*99%=84%.|Exact binomial test|93.5||||0.0322|1-Sided|90.0|89.5||||Exact binomial test|||"Hypothesis: H0: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day at most as large as that of the PG.~Ha: The primary safety endpoint absence from event rate in the VENOVO Venous Stent (BVS) through 30 day is better than that of the PG."|
1606261|NCT02655887|2950247|Non-Inferiority|PG of 74%, which was set at 10% (non-inferiority margin) below the weighted mean of primary patency (PP2) rate at 12 month at a combination of 55% (PTS) subjects at primary patency rate of 77.1% and 45% (NIVL) subjects at primary patency rate of 93.4%. When taking into consideration both co-primary efficacy and safety endpoints, with 138 BVS subjects, the overall study power is at least 85%*99%=84%.|Weighted Z-statistics|88.3||||0.0001|1-Sided|90.0|82.4||||Weighted Z-statistics|||"Hypothesis: H0 :Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is at most as good as that of the PG.~Ha: Primary patency rate at 12 months post-index procedure from the overall VENOVO Venous Stent (BVS) patients (PTS and NIVL combined) is better than that of PG."|
1606262|NCT02655237|2950342|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-1.4|||||2-Sided|95.0|-3.96|1.09|||||Relugolix 40 mg-Leuprorelin|Follow-Up (up to Week 28)|
1606263|NCT02655237|2950342|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.3|||||2-Sided|95.0|-2.07|2.71|||||Relugolix 40 mg-Leuprorelin|Week 24|
1606264|NCT02655237|2950342|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.8|||||2-Sided|95.0|-1.74|3.41|||||Relugolix 40 mg-Leuprorelin|Week 20|
1606265|NCT02655237|2950342|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.1|||||2-Sided|95.0|-2.61|2.79|||||Relugolix 40 mg-Leuprorelin|Week 16|
1606266|NCT02655237|2950342|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.9|||||2-Sided|95.0|-1.84|3.61|||||Relugolix 40 mg-Leuprorelin|Week 12|
1606267|NCT02655237|2950342|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|2.7|||||2-Sided|95.0|-0.37|5.77|||||Relugolix 40 mg-Leuprorelin|Week 8|
1606268|NCT02655237|2950342|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|2.3|||||2-Sided|95.0|-1.66|6.34|||||Relugolix 40 mg-Leuprorelin|Week 4|
1606269|NCT02655237|2950343|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|3.4|||||2-Sided|95.0|1.08|5.77|||||Relugolix 40 mg-Leuprorelin|Follow-Up (up to Week 28)|
1606270|NCT02655237|2950343|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.5|||||2-Sided|95.0|-1.48|2.52|||||Relugolix 40 mg-Leuprorelin|Week 24|
1606271|NCT02655237|2950343|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.3|||||2-Sided|95.0|-1.8|2.32|||||Relugolix 40 mg-Leuprorelin|Week 20|
1606272|NCT02655237|2950343|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|1.3|||||2-Sided|95.0|-0.68|3.28|||||Relugolix 40 mg-Leuprorelin|Week 16|
1606273|NCT02655237|2950343|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.2|||||2-Sided|95.0|-1.99|2.36|||||Relugolix 40 mg-Leuprorelin|Week 12|
1606274|NCT02655237|2950343|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-4.0|||||2-Sided|95.0|-6.68|-1.31|||||Relugolix 40 mg-Leuprorelin|Week 8|
1606275|NCT02655237|2950343|Other|The mean differences in the observed values between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-2.5|||||2-Sided|95.0|-6.39|1.43|||||Relugolix 40 mg-Leuprorelin|Week 4|
1606276|NCT02655237|2950344|Other|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.02|||||2-Sided|95.0|-0.063|0.099|||||Relugolix 40 mg-Leuprorelin|For 6 Weeks Before the Final Dose (up to Week 24)|
1606277|NCT02655237|2950344|Other|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.01|||||2-Sided|95.0|-0.06|0.086|||||Relugolix 40 mg-Leuprorelin|Week 18 to 24|
1606278|NCT02655237|2950344|Other|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.05|||||2-Sided|95.0|-0.089|0.197|||||Relugolix 40 mg-Leuprorelin|Week 2 to 6|
1606279|NCT02655237|2950344|Other|Two-sided 95% confidence interval of the difference was calculated between relugolix 40 mg and leuprorelin group.|Mean Difference (Each Visit)|0.07|||||2-Sided|95.0|-0.032|0.174|||||Relugolix 40 mg-Leuprorelin|Week 6 to 12|
1606280|NCT02655237|2950345|Other|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.49|||||2-Sided|95.0|-0.787|-0.199|||||Relugolix 40 mg-Leuprorelin|Follow up (up to Week 28)|
1606281|NCT02655237|2950345|Other|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.09|||||2-Sided|95.0|-0.385|0.209|||||Relugolix 40 mg-Leuprorelin|Week 24|
1606282|NCT02655237|2950345|Other|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.1|||||2-Sided|95.0|-0.386|0.18|||||Relugolix 40 mg-Leuprorelin|Week 20|
1606283|NCT02655237|2950345|Other|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|-0.01|||||2-Sided|95.0|-0.275|0.251|||||Relugolix 40 mg-Leuprorelin|Week 16|
1606284|NCT02655237|2950345|Other|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.07|||||2-Sided|95.0|-0.189|0.323|||||Relugolix 40 mg-Leuprorelin|Week 12|
1606285|NCT02655237|2950345|Other|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.1|||||2-Sided|95.0|-0.135|0.333|||||Relugolix 40 mg-Leuprorelin|Week 8|
1606286|NCT02655237|2950345|Other|The mean differences in the change from baseline between relugolix 40 mg and leuprorelin groups and the two-sided 95% confidence intervals were calculated for each visit.|Mean Difference (Each Visit)|0.2|||||2-Sided|95.0|0.015|0.381|||||Relugolix 40 mg-Leuprorelin|Week 4|
1606287|NCT02655237|2950346|Other|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|0.86|||||2-Sided|95.0|-6.206|7.935|||||Relugolix 40 mg-Leuprorelin|Week 24|
1606288|NCT02655237|2950346|Other|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-0.94|||||2-Sided|95.0|-6.964|5.076|||||Relugolix 40 mg-Leuprorelin|Week 12|
1606385|NCT02651688|2950564|Superiority|||||||0.4341|||||||Wilcoxon rank-sum test||||
1606289|NCT02655237|2950346|Other|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-0.89|||||2-Sided|95.0|-6.996|5.209|||||Relugolix 40 mg-Leuprorelin|Week 8|
1606290|NCT02655237|2950346|Other|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-10.27|||||2-Sided|95.0|-17.291|-3.246|||||Relugolix 40 mg-Leuprorelin|Week 4|
1606291|NCT02655237|2950346|Other|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-15.15|||||2-Sided|95.0|-20.786|-9.509|||||Relugolix 40 mg-Leuprorelin|Week 2|
1606292|NCT02655237|2950347|Other|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|3.96|||||2-Sided|95.0|-3.319|11.245|||||Relugolix 40 mg-Leuprorelin|Week 24|
1606293|NCT02655237|2950347|Other|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|3.59|||||2-Sided|95.0|-3.433|10.605|||||Relugolix 40 mg-Leuprorelin|Week 12|
1606294|NCT02655237|2950347|Other|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|4.69|||||2-Sided|95.0|-3.141|12.529|||||Relugolix 40 mg-Leuprorelin|Week 8|
1606295|NCT02655237|2950347|Other|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-2.55|||||2-Sided|95.0|-11.916|6.819|||||Relugolix 40 mg-Leuprorelin|Week 4|
1606296|NCT02655237|2950347|Other|The mean differences in the percent changes from baseline between relugolix 40 mg and leuprorelin group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Visit)|-12.05|||||2-Sided|95.0|-19.778|-4.33|||||Relugolix 40 mg-Leuprorelin|Week 2|
1606297|NCT02655237|2950348|Other|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|-13.3|||||2-Sided|95.0|-21.418|-5.118|||||Relugolix 40 mg-Leuprorelin||
1606298|NCT02655237|2950349|Other|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|-10.6|||||2-Sided|95.0|-18.337|-2.883|||||Relugolix 40 mg-Leuprorelin||
1606299|NCT02655237|2950350|Other|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between relugolix 40 mg group and leuprorelin group, using FM method with the non-inferiority margin of -15%. The confidence interval was presented in a descriptive manner and not for the purpose of statistical inference.|Difference in percentage|32.5|||||2-Sided|95.0|20.953|44.134|||||Relugolix 40 mg-Leuprorelin||
1606300|NCT02655237|2950351|Non-Inferiority|The point estimate and 2-sided 95% confidence interval of the difference in the percentage were calculated between Relugolix 40 mg group and leuprorelin group (Relugolix 40 mg group – leuprorelin group), using Farrington and Manning (FM) method. If the lower boundary of the 95% CI was greater or equal to the non-inferiority margin of -15%, then the non-inferiority of Relugolix 40 mg to leuprorelin was concluded.|Difference in percentage|-0.9||||0.0013|2-Sided|95.0|-10.098|8.346|||Farrington and Manning (FM)||Relugolix 40 mg-Leuprorelin||
1606301|NCT02655224|2950357|Other|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|11.6|||||2-Sided|95.0|-3.554|26.745|||||Relugolix 40 mg-Placebo|Day 57 to 84|
1606302|NCT02655224|2950357|Other|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|12.7|||||2-Sided|95.0|-3.098|28.494|||||Relugolix 40 mg-Placebo|Day 29 to 56|
1606303|NCT02655224|2950357|Other|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|4.17|||||2-Sided|95.0|-11.507|19.839|||||Relugolix 40 mg-Placebo|Day 1 to 28|
1606304|NCT02655224|2950358|Other|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|-0.54|||||2-Sided|95.0|-1.074|-0.012|||||Relugolix 40 mg-Placebo|Day 57 to 84|
1606305|NCT02655224|2950358|Other|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|-0.57|||||2-Sided|95.0|-1.19|0.049|||||Relugolix 40 mg-Placebo|Day 29 to 56|
1606306|NCT02655224|2950358|Other|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Each Period)|0.09|||||2-Sided|95.0|-0.574|0.745|||||Relugolix 40 mg-Placebo|Day 1 to 28|
1606307|NCT02655224|2950359|Other|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|12.794|||||2-Sided|95.0|2.603|62.88|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 57 to 84|
1606308|NCT02655224|2950359|Other|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|5.438|||||2-Sided|95.0|1.071|27.609|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 29 to 56|
1606309|NCT02655224|2950360|Other|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|9.865|||||2-Sided|95.0|2.784|34.955|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 57 to 84|
1606386|NCT02651688|2950565|Superiority|||||||0.9509|||||||Wilcoxon rank-sum test||||
1606310|NCT02655224|2950360|Other|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|5.625|||||2-Sided|95.0|1.605|19.709|||||Relugolix 40 mg/Placebo. Statistical analysis for Day 29 to 56 and Day 57 to 84, the odds ratio was calculated. For Day 1 to 28, its ratio was not calculated due to zero cell.|Day 29 to 56|
1606311|NCT02655224|2950361|Other|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Final Values)|11.96|||||2-Sided|95.0|-3.201|27.112|||||Relugolix 40 mg-Placebo||
1606312|NCT02655224|2950362|Other|The mean differences between relugolix 40 mg group and placebo group and the two-sided 95% confidence intervals were calculated.|Mean Difference (Final Values)|-0.49|||||2-Sided|95.0|-1.05|0.069|||||Relugolix 40 mg-Placebo||
1606313|NCT02655224|2950363|Other|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|29.176|||||2-Sided|95.0|3.555|239.478|||||Relugolix 40 mg/Placebo||
1606314|NCT02655224|2950364|Superiority|The point estimate and 2-sided 95% confidence interval of odds ratio were calculated between relugolix 40 mg group and placebo group.|Odds Ratio (OR)|42.071|||<|0.0001|2-Sided|95.0|5.113|346.181|||Fisher's Exact Test||Relugolix 40 mg/Placebo||
1606315|NCT02654769|2950367|Equivalence|Difference (Generic - Picato)|90% Wald's confidence interval|-2.64|||<|0.0001|2-Sided|90.0|-13.14|7.86|||Fisher Exact|||Partial Clearance at Week 8|
1606316|NCT02654769|2950368|Equivalence|Difference (Generic- Picato)|90% Wald's confidence interval|-1.87|||<|0.0001|2-Sided|90.0|-12.37|8.63|||Fisher Exact||||
1606317|NCT02654145|2950381|Superiority||Rate ratio|0.36|||<|0.001|2-Sided|95.0|0.28|0.47|||Generalised Estimating Equations||Analysis performed using generalized estimating equation (GEE) model assuming a negative binomial distribution with a covariate of treatment period (pre-treatment , on- and off-treatment), logarithm of time as an offset variable||
1606318|NCT02654145|2950383|Superiority||Mean Difference (Final Values)|-1.34|||<|0.001|2-Sided|95.0|-1.68|-1.0||p- value for Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.11 (Standard Error: 0.14), which was estimated from a meta-analysis of studies NCT01691521 and NCT02281318 using Placebo participants who previously used|Mixed Model Repeated Measures||Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.11 (Standard Error: 0.14), which was estimated from a meta-analysis of studies NCT01691521 and NCT02281318 using Placebo participants who previously used Xolair.||
1606319|NCT02654145|2950383|Superiority||Mean Difference (Final Values)|-0.9|||<|0.001|2-Sided|95.0|-1.13|-0.66||p-value is for Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.55 (Standard Error: 0.05), which was estimated from a meta-analysis of studies NCT01000506 and NCT01691521 using all Placebo participants.|Mixed Model Repeated Measures||Difference (Mepo-Placebo) calculated based on the Historical Placebo estimate of -0.55 (Standard Error: 0.05), which was estimated from a meta-analysis of studies NCT01000506 and NCT01691521 using all Placebo participants.||
1606320|NCT02654132|2950385|Superiority||Odds Ratio (OR)|3.25||||0.0029|2-Sided|95.0|1.49|7.11|||t-test, 2 sided||||
1606321|NCT02654132|2950386|Superiority||Hazard Ratio (HR)|0.54||||0.0078|2-Sided|95.0|0.34|0.86|||Log Rank||||
1606322|NCT02653872|2950393|Non-Inferiority or Equivalence|Geometric mean ratio of AUC (0-t) for AZD7986 administered with itraconazole over AUC (0-t) for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|112.45|||||2-Sided|90.0|103.34|122.37||||||The study was sized for Cmax primarily and not AUC (0-t). A two-sided 90% confidence interval for the ratio of AUC (0-t) between the two treatments groups was used to determine equivalence.|
1606323|NCT02653872|2950393|Non-Inferiority or Equivalence|Geometric mean ratio of AUC (0-t) for AZD7986 administered with verapamil over AUC (0-t) for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|133.51|||||2-Sided|90.0|122.7|145.29||||||The study was sized for Cmax primarily and not AUC (0-t). A two-sided 90% confidence interval for the ratio of AUC (0-t) between the two treatments groups was used to determine equivalence.|
1606324|NCT02653872|2950394|Non-Inferiority or Equivalence|Geometric mean ratio of AUC for AZD7986 administered with itraconazole over AUC for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|113.7|||||2-Sided|90.0|104.69|123.49||||||The study was sized for Cmax primarily and not AUC. A two-sided 90% confidence interval for the ratio of AUC between the two treatments groups was used to determine equivalence.|
1606325|NCT02653872|2950394|Non-Inferiority or Equivalence|Geometric mean ratio of AUC for AZD7986 administered with verapamil over AUC for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|132.25|||||2-Sided|90.0|121.78|143.64||||||The study was sized for Cmax primarily and not AUC. A two-sided 90% confidence interval for the ratio of AUC between the two treatments groups was used to determine equivalence.|
1606326|NCT02653872|2950395|Non-Inferiority or Equivalence|Geometric mean ratio of Cmax for AZD7986 administered with itraconazole over Cmax for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|60.66|||||2-Sided|90.0|53.84|68.34||||||The study was designed based on a test for bioequivalence. Using an estimated standard deviation for Cmax of AZD7986 of less than or equal to 0.202, 12 evaluable subjects were deemed needed to achieve a power of 90%, at an assumed ratio of 0.95, to show that a two-sided 90% confidence interval for the ratio of Cmax between 2 treatments (AZD7986 and AZD7986+ Verapamil/Itraconazole) would be contained within the (0.8;1.25) equivalence limit. 3 extra subjects were added to compensate for dropout.|
1606327|NCT02653872|2950395|Non-Inferiority or Equivalence|Geometric mean ratio of Cmax for AZD7986 administered with verapamil over Cmax for AZD7986 administered alone. Presented as a percentage.|% Geometric Mean Ratio|153.4|||||2-Sided|90.0|136.16|172.83||||||The study was designed based on a test for bioequivalence. Using an estimated standard deviation for Cmax of AZD7986 of less than or equal to 0.202, 12 evaluable subjects were deemed needed to achieve a power of 90%, at an assumed ratio of 0.95, to show that a two-sided 90% confidence interval for the ratio of Cmax between 2 treatments (AZD7986 and AZD7986+ Verapamil/Itraconazole) would be contained within the (0.8;1.25) equivalence limit. 3 extra subjects were added to compensate for dropout.|
1606328|NCT02653768|2950396|Other||Mean Difference (Final Values)|-2.3||||0.23|2-Sided|95.0|-6.1|1.5|||Mixed Models Analysis||||
1606329|NCT02653768|2950397|Superiority||Mean Difference (Final Values)|0.4||||0.43|2-Sided|95.0|-0.6|1.3|||Mixed Models Analysis|||This is the analysis between-group difference in change from baseline to 9-month follow-up for the 30 second chair stand.|
1606330|NCT02653768|2950398|Superiority||Mean Difference (Final Values)|-6.8||||0.0003|2-Sided|95.0|-10.5|-3.2|||Mixed Models Analysis|||This is the analysis of between-group difference in change from baseline to 9-month follow-up. This is the primary outcome assessment time point.|
1606331|NCT02653768|2950398|Other|As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.|Mean Difference (Final Values)|-1.4|||||2-Sided|95.0|-5.2|2.3||||||This is the analysis of between-group difference in change from baseline to 6-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.|
1606332|NCT02653768|2950398|Other|As noted above, a statistical test was not specified at this time point. Rather, the data for all time points were included in the model and are presented here descriptively.|Mean Difference (Final Values)|-5.1|||||2-Sided|95.0|-8.2|-2.0||||||This analysis of between-group difference in change from baseline to 3-month follow-up. We have not included a p-value because there was no pre-specified hypothesis for this time point. Rather, these are additional data obtained from the overall model, for which the 9-month time point was primary and included a pre-specified hypothesis.|
1606333|NCT02653417|2950418|Superiority||Mean Difference (Final Values)|0.46|||||2-Sided|||||||||Regimen 3 = 20 mg vs Regimen 4 = placebo|
1606334|NCT02653417|2950418|Superiority||Mean Difference (Final Values)|0.08|||||2-Sided|||||||||Regimen 2 = 10 mg vs Regimen 4 = placebo|
1606335|NCT02653417|2950418|Superiority||Mean Difference (Final Values)|-0.18|||||2-Sided|||||||||Regimen 1 = 5 mg vs Regimen 4 = placebo|
1606336|NCT02653326|2950421|Superiority|||||||0.32|||||||t-test, 2 sided||||
1606337|NCT02653326|2950422|Superiority|||||||0.63|||||||t-test, 2 sided||||
1606338|NCT02653170|2950440|Superiority|||||||0.993||||||P-value represents the test of the interaction term for a difference-in-differences (DID) model [i.e., 2 degree freedom test of the interaction between intervention group*time]|Mixed Models Analysis|||Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group * time interaction term.|
1606339|NCT02653170|2950441|Superiority||difference-in-differences (DID) p-value|0.042||||0.042|2-Sided|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model [i.e., 2 degree freedom test of the interaction between intervention group*time]|Mixed Models Analysis||The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.651 (p=0.558), SWSCM+VSSP vs Usual Care = 5.023 (p=0.073), SWSCM+VSSP vs SWSCM = 6.674 (p=0.016)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group * time interaction term.|
1606340|NCT02653170|2950442|Superiority|||||||0.789||||||P-value represents the test of the interaction term for a difference-in-differences (DID) model [i.e., 2 degree freedom test of the interaction between intervention group*time]|Mixed Models Analysis|||Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group * time interaction term.|
1606341|NCT02653170|2950443|Superiority||difference-in-differences (DID) p-value|0.562||||0.562|2-Sided|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model [i.e., 2 degree freedom test of the interaction between intervention group*time]|Mixed Models Analysis|PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term|The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = -1.064 (p=0.422), SWSCM+VSSP vs Usual Care = 0.258 (p=0.844), SWSCM+VSSP vs SWSCM = 1.322 (p=0.309)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group * time interaction term.|
1606342|NCT02653170|2950444|Superiority||difference-in-differences (DID) p-value|0.025||||0.025|2-Sided|||||P-value represents the test of the interaction term for a difference-in-differences (DID) model [i.e., 2 degree freedom test of the interaction between intervention group*time]|Mixed Models Analysis|PROC MIXED MODEL including main effects of intervention group (UC, SWSCM, SWSCM+VSSP website) and time (7-day and 90-day) plus the interaction term|The DID estimates contrasting the 90-day minus 7-day differences in each group are as follows: SWSCM vs Usual Care = 0.970 (p=0.335), SWSCM+VSSP vs Usual Care = 3.370 (p<0.001), SWSCM+VSSP vs SWSCM = 2.400 (p=0.016)|Data were analyzed as the change over time between treatment groups (i.e., 90-day least square mean minus 7-day least square mean) using a difference-in-differences (DID) analysis that involves a group * time interaction term.|
1606343|NCT02652949|2950452|Superiority||Event rate|0.023|||<|0.0001|1-Sided|97.5||0.081|||Exact binomial test|||"The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:~H0: p ≥ 16% vs. Ha: p <16%, where p denotes the true event rate of primary study endpoint in the target population."|
1606344|NCT02652780|2950464|Superiority||Mean Difference (Net)|-0.008||||0.8783|2-Sided|95.0|-0.119|0.102|||ANCOVA|||A mixed model of analysis of covariance (ANCOVA) was used with change from baseline at Week 48 as the response, and participants, eyes of the participant as random factor, treatment and baseline LogMAR value as covariates in the model. P-value is used to assess the significance of the difference between All-GS010 and All-Sham with respect to change of LogMAR from baseline.|
1606345|NCT02652767|2950476|Superiority||Mean Difference (Net)|-0.012||||0.889|2-Sided|95.0|-0.182|0.158|||ANCOVA|||A mixed model of analysis of covariance (ANCOVA) was used with change from baseline at Week 48 as the response, and participants, eyes of the participant as random factor, treatment and baseline LogMAR value as covariates in the model. P-value is used to assess the significance of the difference between All-GS010 and All-Sham with respect to change of LogMAR from baseline.|
1606346|NCT02652624|2950477|Other||Difference in least square means|3.0||||0.84|2-Sided|95.0|-27.0|34.0|||ANOVA||Difference in least squares means and its 95% CI were from ANOVA model with treatment group as a fixed effect in the model.||
1606347|NCT02652624|2950478|Superiority|||||||1|||||||Fisher Exact||||
1606348|NCT02652624|2950478|Non-Inferiority|The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.001% CI of the difference between the treatment groups (B/F/TAF group - SBR group) in the percentage of participants with HIV-1 RNA < 50 copies/mL is greater than -10%.|Difference in percentages|0.4|||||2-Sided|95.001|-3.7|4.5|||||The difference in percentages between treatment groups and their 95.001% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.||
1606349|NCT02652624|2950479|Superiority|||||||1|||||||Fisher Exact||||
1606350|NCT02652624|2950479|Non-Inferiority|A sample size of 470 participants (~235 participants per treatment group) would provide at least 87% power to detect a non-inferiority margin of 4% difference in the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 between the 2 treatment groups. This was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.|Difference in percentages|0.0|||||2-Sided|95.001|-2.9|2.9|||||The difference in percentages between treatment groups and their 95.001% confidence intervals (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.|
1606351|NCT02652260|2950520|Other|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-22.18|||||2-Sided|95.0|-38.52|-5.84||||||Difference Estimate: Triglyceride|ISG minus DSG
1606352|NCT02652260|2950520|Other|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-8.18|||||2-Sided|95.0|-11.76|-4.6||||||Difference Estimate: HDL Cholesterol|ISG minus DSG
1606353|NCT02652260|2950520|Other|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-21.42|||||2-Sided|95.0|-29.63|-13.21||||||Difference Estimate: Cholesterol|ISG minus DSG
1606354|NCT02652260|2950520|Other|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-13.57|||||2-Sided|95.0|-20.79|-6.35||||||Difference Estimate: Non-HDL Cholesterol|ISG minus DSG
1606355|NCT02652260|2950520|Other|The 95% CI for treatment difference was calculated from an ANCOVA model with terms for baseline lipid level, use of lipid lowering therapy at study Day 1 and treatment|Difference Estimate|-9.02|||||2-Sided|95.0|-15.69|-2.35||||||Difference Estimate: LDL Cholesterol|ISG minus DSG
1606356|NCT02652260|2950521|Other|The 95% CI was based on a t-distribution.|Mean Difference (Final Values)|-13.4|||||2-Sided|95.0|-16.8|-10.1||||||Change from time of switch to 24 weeks post-switch: Treatment difference in score|Week 24 Post-switch minus Time of switch
1606357|NCT02652260|2950522|Other|The 95% CI was calculated by the method of Miettinen and Nurminen.|Difference in Percentage|-38.4|||||2-Sided|95.0|-51.2|-23.8||||||Change from time of switch to 24 weeks post-switch: Treatment difference in percent response|Week 24 Post-switch minus Time of switch
1606358|NCT02652260|2950523|Other||Estimated Difference|3.6|||||2-Sided|95.0|-4.1|11.3||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was calculated by the method of Miettinen and Nurminen.
1606359|NCT02652260|2950524|Other||Estimated Difference|-2.0|||||2-Sided|95.0|-10.5|6.5||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was based on a t-distribution.
1606360|NCT02652260|2950525|Other|The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.|Estimated Difference|-18.61|||||2-Sided|95.0|-38.14|2.51||||||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% CI was calculated by the method of Miettinen and Nurminen.
1606361|NCT02652260|2950526|Other|The Immediate Switch group will be considered statistically significantly smaller than the Delayed Switch group if the upper bound of the 95% confidence interval for the treatment difference is less than 0.|Estimated Difference|4.65||||0.331|2-Sided|95.0|-15.92|24.85|||Miettinen and Nurminen|||Treatment Difference: Immediate Switch minus Delayed Switch|The 95% confidence interval (CI) was calculated by the method of Miettinen and Nurminen.
1606362|NCT02651688|2950553|Superiority|||||||0.0225|||||||Wilcoxon rank-sum test||||
1606363|NCT02651688|2950553|Superiority|||||||0.0139|||||||Wilcoxon rank-sum test||||
1606364|NCT02651688|2950554|Superiority|||||||0.1333|||||||Wilcoxon rank-sum||||
1606365|NCT02651688|2950554|Superiority|||||||0.0992|||||||Wilcoxon rank-sum test||||
1606366|NCT02651688|2950555|Superiority|||||||0.0364|||||||Wilcoxon rank-sum test||||
1606367|NCT02651688|2950555|Superiority|||||||0.0168|||||||Wilcoxon rank-sum test||||
1606368|NCT02651688|2950556|Superiority|||||||0.5833|||||||Wilcoxon rank-sum test||||
1606369|NCT02651688|2950556|Superiority|||||||0.5581|||||||Wilcoxon rank-sum test||||
1606370|NCT02651688|2950557|Superiority|||||||0.5732|||||||Wilcoxon rank-sum test||||
1606371|NCT02651688|2950557|Superiority|||||||0.1546|||||||Wilcoxon rank-sum test||||
1606372|NCT02651688|2950558|Superiority|||||||0.3263|||||||Wilcoxon rank-sum test||||
1606373|NCT02651688|2950558|Superiority|||||||0.1144|||||||Wilcoxon rank-sum test||||
1606374|NCT02651688|2950559|Superiority|||||||0.4183|||||||Wilcoxon rank-sum test||||
1606375|NCT02651688|2950559|Superiority|||||||0.826|||||||Wilcoxon rank-sum test||||
1606376|NCT02651688|2950560|Superiority|||||||0.2235|||||||Wilcoxon rank-sum test||||
1606377|NCT02651688|2950560|Superiority|||||||0.045|||||||Wilcoxon rank-sum test||||
1606378|NCT02651688|2950561|Superiority|||||||0.3261|||||||Wilcoxon rank-sum test||||
1606379|NCT02651688|2950561|Superiority|||||||0.2962|||||||Wilcoxon rank-sum test||||
1606380|NCT02651688|2950562|Superiority|||||||0.4517|||||||Wilcoxon rank-sum test||||
1606381|NCT02651688|2950562|Superiority|||||||0.9074|||||||Wilcoxon rank-sum test||||
1606382|NCT02651688|2950563|Superiority|||||||0.3677|||||||Wilcoxon rank-sum test||||
1606402|NCT02651584|2950573|Non-Inferiority or Equivalence|The p-value was based on the chi square test for non-inferiority with the margin of 15%.||||||0.006|||||||Chi-squared||||
1606403|NCT02651584|2950575|Superiority|||||||0.008|||||||Wilcoxon Rank-Sum|||not including self-reported opioid use|
1606404|NCT02651584|2950575|Superiority|||||||0.004|||||||Wilcoxon Rank-Sum|||including subject self-reported opioid use|
1606405|NCT02651584|2950576|Non-Inferiority|The p-value was based on the chi square test for non-inferiority with the margin of 10% point.|||||<|0.001|||||||Chi-squared||||
1606406|NCT02651467|2950580|Superiority or Other||Least Square Mean Difference|0.15||||0.2478||95.0|-0.107|0.413||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1606407|NCT02651467|2950581|Superiority or Other||Diference of Least Square mean|-1.04|||<|0.0001|2-Sided|95.0|-1.333|-0.738||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|For the Week 8 comparisons of the two Treatments against the control, Dunnett’s multiplicity adjustment is applied.|
1606408|NCT02651467|2950581|Superiority or Other||Difference of Least Square mean|-0.88|||<|0.0001|2-Sided|95.0|-1.181|-0.584||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|For the Week 8 comparisons of the two Treatments against the Placebo Control, Dunnett’s multiplicity adjustment is applied.|
1606409|NCT02651155|2950620|Superiority or Other||Median Values of CI|1.0||||0.003|2-Sided|95.0|0.1|1.0|||Van Elteren Test|SBM was analyzed using Van Elteren Test stratified by center. Centers with less participants were pooled based on geographical proximity.|CI was estimated by inverting the hypothesis test.||
1606410|NCT02650921|2950649|Superiority||Difference in Responder Rate|45.8|||<|0.0001|2-Sided|95.0|32.3|59.3|||McNemar||||
1606411|NCT02650921|2950650|Superiority||Difference in Responder Rate|57.3|||<|0.0001|2-Sided|95.0|44.8|69.8|||McNemar||||
1606412|NCT02650921|2950651|Superiority||Difference in Responder Rate|72.3|||<|0.0001|2-Sided|95.0|61.9|82.7|||McNemar||||
1606413|NCT02650921|2950652|Superiority||Difference in Responder Rate|64.7|||<|0.0001|2-Sided|95.0|53.3|76.1|||McNemar||||
1606414|NCT02649946|2950736|Non-Inferiority|Non-inferiority Farrington and Manning Exact Test is used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025.||||||0.0022|||||||Farrington and Manning|Non-inferiority test with non-inferiority margin of 10%.||"Hypothesis: The safety rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) is non-inferior to the safety rate in subjects treated with PTA alone through 30 days in the treatment of stenotic lesions.~Sample size: 238 randomized subjects [226 evaluable] will give 85% power with one-sided type 1 error = 0.025."|
1606415|NCT02649946|2950737|Superiority|TLPP evaluated at 6 months post-index procedure to assess if TLPP of COVERA is superior to that of PTA alone, by direct comparison.|||||<|0.001||||||Test successful if the one-side p-value is less than 0.025 and the result is in favor of the COVERA Vascular Covered Stent.|Chi-squared|||"Hypothesis: The (survival) rate in subjects treated with the COVERA Vascular Covered Stent (following PTA) with respect to TLPP through 6 months is greater than that in subjects treated with PTA alone in the treatment of stenoses in the upper extremity venous outflow of subjects dializing with an AV fistula.~Sample size calculation: 238 randomized subjects [214 evaluable] will give 92% power with one-sided type 1 error = 0.025."|
1606416|NCT02649634|2950741|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Confidence for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Confidence for Change ratings on the 11-point visual analogue scales|
1606417|NCT02649634|2950742|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Readiness for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Readiness for Change ratings on the 11-point visual analogue scales|
1606418|NCT02649634|2950743|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Importance of Change ratings were analyzed via an independent sample t-test comparing the groups on mean Importance of Change ratings on the 11-point visual analogue scales|
1606419|NCT02649634|2950744|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Confidence for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Confidence for Change ratings on the 11-point visual analogue scales|
1606420|NCT02649634|2950745|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Readiness for Change ratings were analyzed via an independent sample t-test comparing the groups on mean Readiness for Change ratings on the 11-point visual analogue scales|
1606421|NCT02649634|2950746|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Importance of Change ratings were analyzed via an independent sample t-test comparing the groups on mean Importance of Change ratings on the 11-point visual analogue scales|
1606422|NCT02649634|2950747|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean self efficacy rating on the ESE.|
1606423|NCT02649634|2950748|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean global self efficacy rating on the WEL.|
1606424|NCT02649634|2950749|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean self efficacy rating on the ESE.|
1606425|NCT02649634|2950750|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.|||||>|0.05||||||Significance threshold is p=.05|t-test, 2 sided|||Self-efficacy was analyzed via an independent sample t-test comparing the groups on mean global self efficacy rating on the WEL.|
1606426|NCT02649634|2950751|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.|
1606427|NCT02649634|2950752|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.|
1606428|NCT02649634|2950753|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.|
1606429|NCT02649634|2950754|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.|
1606430|NCT02649634|2950755|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.|
1606431|NCT02649634|2950756|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.|
1606432|NCT02649634|2950757|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.|
1606433|NCT02649634|2950758|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.|
1606434|NCT02649634|2950759|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.|
1606459|NCT02649192|2950780|Superiority|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2015-16 season|
1607171|NCT02634073|2952054|Superiority or Other||Ratio|0.803|||||2-Sided|90.0|0.747|0.864|||||AUC (0-24) comparision||
1606435|NCT02649634|2950760|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.|
1606436|NCT02649634|2950761|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used.|
1606437|NCT02649634|2950762|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used|
1606438|NCT02649634|2950763|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used|
1606439|NCT02649634|2950764|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size.||||||0.65|||||||t-test, 2 sided|||Treatment adherence was analyzed via an independent sample t-test comparing the groups on mean number of TrymGym sessions missed.|
1606440|NCT02649634|2950765|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05|Mixed Models Analysis|||Linear Mixed Modelling (LMM) was used|
1606441|NCT02649634|2950766|Non-Inferiority or Equivalence|Estimated sample size needed was 90 (45/group). This was based on a sample size calculation for 2 groups with 0.05 alpha, 0.80 power, anticipating a medium effect size (most recent meta-analysis on efficacy of MI on dietary behaviours yielded a medium effect size of .53; Burke et al., 2003). Additionally, for MLM, estimates involving the Level 2 variable (i.e., participants) require samples larger than 50 (Maas & Hox, 2005). Others have suggested 30-50 participants (Scherbaum & Ferreter, 2009).|||||>|0.05||||||Significance threshold is p=.05.|Mixed Models Analysis|||Linear mixed modelling (LMM) was used|
1606442|NCT02649192|2950779|Superiority||Treatment Difference in Seroconversion R|-8.4|||||2-Sided|95.0|-45.4|30.5|||||Treatment group minus placebo|B/Brisbane|
1606443|NCT02649192|2950779|Superiority||Treatment Difference in Seroconversion R|-26.4|||||2-Sided|95.0|-54.1|5.8|||||Treatment group minus placebo|B/Brisbane|
1606444|NCT02649192|2950779|Superiority||Treatment Difference in Seroconversion R|0.0|||||2-Sided|95.0|0.0|0.0|||||Treatment group minus placebo|B/Brisbane|
1606445|NCT02649192|2950779|Superiority||Treatment Difference in Seroconversion R|16.9|||||2-Sided|95.0|-23.1|53.3|||||Treatment group minus placebo|B/Phuket|
1606446|NCT02649192|2950779|Superiority||Treatment Difference in Seroconversion R|-26.4|||||2-Sided|95.0|-54.1|5.8|||||Treatment group minus placebo|B/Phuket|
1606447|NCT02649192|2950779|Superiority||Treatment Difference in Seroconversion R|0.0|||||2-Sided|95.0|0.0|0.0|||||Treatment group minus placebo|B/Phuket|
1606448|NCT02649192|2950779|Superiority||Treatment Difference in Seroconversion R|22.7|||||2-Sided|95.0|-17.5|57.9|||||Treatment group minus placebo|H3N2|
1606449|NCT02649192|2950779|Superiority||Treatment Difference in Seroconversion R|-8.6|||||2-Sided|95.0|-38.8|20.6|||||Treatment group minus placebo|H3N2|
1606450|NCT02649192|2950779|Superiority||Treatment Difference in Seroconversion R|-10.0|||||2-Sided|95.0|-70.1|56.1|||||Treatment group minus placebo|H3N2|
1606451|NCT02649192|2950779|Superiority||Treatment Difference in Seroconversion R|-13.0|||||2-Sided|95.0|-49.4|26.5|||||Treatment group minus placebo|H1N1|
1606452|NCT02649192|2950779|Superiority||Treatment Difference in Seroconversion R|-23.6|||||2-Sided|95.0|-51.7|6.2|||||Treatment group minus placebo|H1N1|
1606453|NCT02649192|2950779|Superiority||Treatment Difference in Seroconversion R|0.0|||||2-Sided|95.0|0.0|0.0|||||Treatment group minus placebo|H1N1|
1606454|NCT02649192|2950780|Superiority|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2017-18 season|
1606455|NCT02649192|2950780|Superiority|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2016-17 season|
1606456|NCT02649192|2950780|Superiority|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgM at day 56 in 2015-16 season|
1606457|NCT02649192|2950780|Superiority|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2017-18 season|
1606458|NCT02649192|2950780|Superiority|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG3 at day 56 in 2016-17 season|
1606460|NCT02649192|2950780|Superiority|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2017-18 season|
1606461|NCT02649192|2950780|Superiority|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2016-17 season|
1606462|NCT02649192|2950780|Superiority|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG2 at day 56 in 2015-16 season|
1606463|NCT02649192|2950780|Superiority|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2017-18 season|
1606464|NCT02649192|2950780|Superiority|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2016-17 season|
1606465|NCT02649192|2950780|Superiority|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No difference between intervention and placebo groups in the ratio of IgA/IgG1 at day 56 in 2015-16 season|
1606466|NCT02648438|2950830|Superiority or Other||Geometric mean ratio|101.15|||||2-Sided|90.0|85.21|120.06|||||Ratio (%)|Statistical Assessment of AZD7594 Pharmacokinetic Parameter (AUC0-t) Following Inhalation Administration ofAZD7594 via DPI Device 2 Versus DPI Device 1.|
1606467|NCT02648438|2950831|Superiority or Other||Geometric mean ratio|62.61|||||2-Sided|90.0|53.01|73.94|||||Ratio (%)|Statistical Assessment of AZD7594 Pharmacokinetic Parameter (AUC0-t) Following Inhalation Administration ofAZD7594 via DPI Device 2 Versus DPI Device 1.|
1606468|NCT02648217|2950841|Superiority or Other||Treatment Contrast|0.02||||0.8426|2-Sided|95.0|-0.2|0.24|||Mixed model for repeated measurements|||The endpoint was analysed using mixed model for repeated measurements (MMRM) with an unstructured covariance matrix. The model included treatment, sex, region, previous OAD treatment, pre-Ramadan trial exposure and visit as factors and age and baseline value of the endpoint as covariates. Interactions between visit and all factors and covariates are included in the model.|
1606469|NCT02648204|2950868|Superiority||Treatment difference|-3.55|Standard Error of the Mean|0.39|<|0.0001|2-Sided|95.0|-4.32|-2.78|||Mixed Models Analysis||||
1606470|NCT02648204|2950868|Superiority||Treatment difference|-2.26|Standard Error of the Mean|0.39|<|0.0001|2-Sided|95.0|-3.02|-1.51|||Mixed Models Analysis||||
1606471|NCT02648204|2950869|Superiority||Treatment difference|-0.41|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.57|-0.25|||Mixed Models Analysis||||
1606472|NCT02648204|2950869|Non-Inferiority|Non-Inferiority margin: 0.04|Treatment difference|-0.41|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.57|-0.25|||Mixed Models Analysis||||
1606473|NCT02648204|2950869|Superiority||Treatment difference|-0.4|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.55|-0.25|||Mixed Models Analysis||||
1606474|NCT02648204|2950869|Non-Inferiority|Non-Inferiority margin: 0.4|Treatment difference|-0.4|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.55|-0.25|||Mixed Models Analysis||||
1606475|NCT02648178|2950871|Other|We used a linear mixed model to estimate associations between cigarette smoking and that of e-cigarette smoking, by week and their interactions. We also used the same model to estimate association between biomarkers such as NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), Nicotine, Cotinine, Hydro and Creatinine and CO (Carbon Monoxide) level,by week and their interactions.|||||||||||||||||We used a linear mixed model to estimate associations between cigarette smoking and that of e-cigarette smoking, week and their interactions. We also used the same model to estimate association between biomarkers such as NNAL, Nicotine, Cotinine, Hydro and Creatinine and CO level, week and their interactions.
1606476|NCT02648022|2950874|Superiority or Other||Odds Ratio (OR)|2.91||||0.07|2-Sided|95.0|0.92|9.27|||Regression, Linear|Multivariable Regression Analysis|||
1606477|NCT02647944|2950875|Superiority|||||||0.95|||||||Wilcoxon (Mann-Whitney)||||
1606478|NCT02647944|2950876|Superiority|||||||0.68|||||||Wilcoxon (Mann-Whitney)||||
1606479|NCT02647944|2950877|Superiority|||||||0.13|||||||Wilcoxon (Mann-Whitney)||||
1606480|NCT02647944|2950878|Superiority|||||||0.054|||||||Wilcoxon (Mann-Whitney)||||
1606481|NCT02647944|2950879|Superiority|||||||0.069|||||||Wilcoxon (Mann-Whitney)||||
1606482|NCT02647944|2950880|Superiority|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1606483|NCT02647944|2950881|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1606484|NCT02647944|2950882|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1606485|NCT02647645|2950914|Superiority|Power calculation was based on the investigators' estimate of the impact of cognitive training with transcranial direct current stimulation (tDCS) on subjective cognitive problems, as similar studies were not available to develop effect size estimates.||||||0.33||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = .63).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.|
1606486|NCT02647645|2950915|Superiority|Power calculation was based on similar studies of cognitive training with transcranial direct current stimulation (tDCS).||||||0.34||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = .71).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.|
1606520|NCT02647320|2950930|Other||LS Mean Difference|-3.8|Standard Error of the Mean|7.45||0.608|2-Sided|90.0|-16.13|8.48|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606521|NCT02647320|2950930|Other||LS Mean Difference|-1.4|Standard Error of the Mean|7.59||0.852|2-Sided|90.0|-13.96|11.13|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606522|NCT02647320|2950930|Other||LS Mean Difference|0.5|Standard Error of the Mean|8.62||0.951|2-Sided|90.0|-13.7|14.77|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606487|NCT02647645|2950916|Superiority|Power calculation was based on similar studies of cognitive training with transcranial direct current stimulation (tDCS).||||||0.02||||||Probability associated with the test of the interaction between participants' performance and session number in repeated measures analysis of covariance. In light of small sample size, estimated effect size was also calculated (d = 1.78).|ANCOVA|Test was adjusted for age, gender, race, education, CD4 count, and log viral load.||Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, cluster of differentiation (CD4) cell count, and log viral load as covariates.|
1606488|NCT02647320|2950922|Other||LS Mean Difference|-17.4|Standard Error of the Mean|6.88||0.012|2-Sided|90.0|-28.76|-6.03|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606489|NCT02647320|2950922|Other||LS Mean Difference|-13.0|Standard Error of the Mean|7.03||0.067|2-Sided|90.0|-24.6|-1.35|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606490|NCT02647320|2950922|Other||LS Mean Difference|-18.6|Standard Error of the Mean|7.94||0.02|2-Sided|90.0|-31.73|-5.49|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606491|NCT02647320|2950922|Other||LS Mean Difference|-8.7|Standard Error of the Mean|8.11||0.285|2-Sided|90.0|-22.09|4.7|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606492|NCT02647320|2950923|Other||LS Mean Difference|-16.7|Standard Error of the Mean|5.8||0.004|2-Sided|90.0|-26.31|-7.16|||Mixed Model Repeated Measure|||Difference in change at week 8|
1606493|NCT02647320|2950923|Other||LS Mean Difference|-4.1|Standard Error of the Mean|5.81||0.486|2-Sided|90.0|-13.66|5.54|||Mixed Model Repeated Measure|||Difference in change at week 8|
1606494|NCT02647320|2950923|Other||LS Mean Difference|-4.4|Standard Error of the Mean|6.72||0.512|2-Sided|90.0|-15.52|6.68|||Mixed Model Repeated Measure|||Difference in change at week 8|
1606495|NCT02647320|2950923|Other||LS Mean Difference|3.1|Standard Error of the Mean|6.55||0.642|2-Sided|90.0|-7.77|13.88|||Mixed Model Repeated Measure|||Difference in change at week 8|
1606496|NCT02647320|2950924|Other||LS Mean Difference|-13.1|Standard Error of the Mean|5.27||0.13|2-Sided|90.0|-21.83|-4.43|||Mixed Model Repeated Measure|||Difference in change at week 4|
1606497|NCT02647320|2950924|Other||LS Mean Difference|-6.4|Standard Error of the Mean|5.31||0.227|2-Sided|90.0|-15.21|2.33|||Mixed Model Repeated Measure|||Difference in change at week 4|
1606498|NCT02647320|2950924|Other||LS Mean Difference|-11.9|Standard Error of the Mean|6.06||0.05|2-Sided|90.0|-21.94|-1.91|||Mixed Model Repeated Measure|||Difference in change at week 4|
1606499|NCT02647320|2950924|Other||LS Mean Difference|-1.2|Standard Error of the Mean|5.96||0.84|2-Sided|90.0|-11.04|8.63|||Mixed Model Repeated Measure|||Difference in change at week 4|
1606500|NCT02647320|2950925|Other||LS Mean Difference|-27.2|Standard Error of the Mean|5.32|<|0.001|2-Sided|90.0|-35.96|-18.38|||Mixed Model Repeated Measure|||Difference in change at week 2|
1606501|NCT02647320|2950925|Other||LS Mean Difference|-9.5|Standard Error of the Mean|5.32|<|0.074|2-Sided|90.0|-18.31|-0.75|||Mixed Model Repeated Measure|||Difference in change at week 2|
1606502|NCT02647320|2950925|Other||LS Mean Difference|-16.3|Standard Error of the Mean|6.09|<|0.008|2-Sided|90.0|-26.37|-6.27|||Mixed Model Repeated Measure|||Difference in change at week 2|
1606503|NCT02647320|2950925|Other||LS Mean Difference|-6.2|Standard Error of the Mean|5.9|<|0.298|2-Sided|90.0|-15.9|3.6|||Mixed Model Repeated Measure|||Difference in change at week 2|
1606504|NCT02647320|2950926|Other||LS Mean Difference|-31.58|Standard Error of the Mean|10.229||0.002|2-Sided|90.0|-48.482|-14.676|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606505|NCT02647320|2950926|Other||LS Mean Difference|-4.41|Standard Error of the Mean|10.421||0.672|2-Sided|90.0|-21.635|12.807|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606506|NCT02647320|2950926|Other||LS Mean Difference|-7.39|Standard Error of the Mean|0.532||0.532|2-Sided|90.0|-26.927|12.138|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606507|NCT02647320|2950926|Other||LS Mean Difference|-7.61|Standard Error of the Mean|12.001||0.527|2-Sided|90.0|-27.441|12.221|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606508|NCT02647320|2950927|Other||LS Mean Difference|-27.73|Standard Error of the Mean|8.17|<|0.001|2-Sided|90.0|-41.22|-14.236|||Mixed Model Repeated Measure|||Difference in change at week 4|
1606509|NCT02647320|2950927|Other||LS Mean Difference|-2.53|Standard Error of the Mean|8.306|<|0.761|2-Sided|90.0|-16.247|11.185|||Mixed Model Repeated Measure|||Difference in change at week 4|
1606510|NCT02647320|2950927|Other||LS Mean Difference|-8.09|Standard Error of the Mean|9.505|<|0.395|2-Sided|90.0|-23.79|7.604|||Mixed Model Repeated Measure|||Difference in change at week 4|
1606511|NCT02647320|2950927|Other||LS Mean Difference|1.49|Standard Error of the Mean|9.28|<|0.873|2-Sided|90.0|-13.835|16.815|||Mixed Model Repeated Measure|||Difference in change at week 4|
1606512|NCT02647320|2950928|Other||LS Mean Difference|-29.51|Standard Error of the Mean|17.393||0.091|2-Sided|90.0|-58.254|-0.775|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606513|NCT02647320|2950928|Other||LS Mean Difference|17.25|Standard Error of the Mean|17.72||0.331|2-Sided|90.0|-12.03|46.529|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606514|NCT02647320|2950928|Other||LS Mean Difference|24.25|Standard Error of the Mean|20.335||0.235|2-Sided|90.0|-9.354|57.848|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606515|NCT02647320|2950928|Other||LS Mean Difference|4.39|Standard Error of the Mean|20.396||0.83|2-Sided|90.0|-29.312|38.087|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606516|NCT02647320|2950929|Other||LS Mean Difference|-40.03|Standard Error of the Mean|13.472||0.003|2-Sided|90.0|-62.283|-17.787|||Mixed Model Repeated Measure|||Difference in change at week 4|
1606517|NCT02647320|2950929|Other||LS Mean Difference|-3.65|Standard Error of the Mean|13.747||0.791|2-Sided|90.0|-26.352|19.051|||Mixed Model Repeated Measure|||Difference in change at week 4|
1606518|NCT02647320|2950929|Other||LS Mean Difference|-3.27|Standard Error of the Mean|15.853||0.837|2-Sided|90.0|-29.446|22.914|||Mixed Model Repeated Measure|||Difference in change at week 4|
1606519|NCT02647320|2950929|Other||LS Mean Difference|5.32|Standard Error of the Mean|15.289||0.728|2-Sided|90.0|-19.932|30.566|||Mixed Model Repeated Measure|||Difference in change at week 4|
1606523|NCT02647320|2950930|Other||LS Mean Difference|-10.3|Standard Error of the Mean|8.54||0.228|2-Sided|90.0|-24.43|3.78|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606524|NCT02647320|2950931|Other||LS Mean Difference|-2.9|Standard Error of the Mean|3.68||0.431|2-Sided|90.0|-8.99|3.18|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606525|NCT02647320|2950931|Other||LS Mean Difference|-0.3|Standard Error of the Mean|3.75||0.946|2-Sided|90.0|-6.45|5.94|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606526|NCT02647320|2950931|Other||LS Mean Difference|-1.1|Standard Error of the Mean|4.26||0.794|2-Sided|90.0|-8.15|5.92|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606527|NCT02647320|2950931|Other||LS Mean Difference|-7.6|Standard Error of the Mean|4.22||0.072|2-Sided|90.0|-14.57|-0.64|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606528|NCT02647320|2950932|Other||LS Mean Difference|-1.6|Standard Error of the Mean|2.27||0.478|2-Sided|90.0|-5.35|2.13|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606529|NCT02647320|2950932|Other||LS Mean Difference|0.3|Standard Error of the Mean|2.3||0.902|2-Sided|90.0|-3.52|4.08|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606530|NCT02647320|2950932|Other||LS Mean Difference|-1.2|Standard Error of the Mean|2.62||0.646|2-Sided|90.0|-5.53|3.12|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606531|NCT02647320|2950932|Other||LS Mean Difference|1.5|Standard Error of the Mean|2.59||0.576|2-Sided|90.0|-2.83|5.73|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606532|NCT02647320|2950933|Other||LS Mean Difference|-3.9|Standard Error of the Mean|4.77||0.409|2-Sided|90.0|-11.82|3.93|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606533|NCT02647320|2950933|Other||LS Mean Difference|-0.9|Standard Error of the Mean|4.86||0.846|2-Sided|90.0|-8.97|7.08|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606534|NCT02647320|2950933|Other||LS Mean Difference|0.7|Standard Error of the Mean|5.51||0.894|2-Sided|90.0|-8.36|9.84|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606535|NCT02647320|2950933|Other||LS Mean Difference|-6.7|Standard Error of the Mean|5.5||0.228|2-Sided|90.0|-15.74|2.43|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606536|NCT02647320|2950934|Other||LS Mean Difference|-3.1|Standard Error of the Mean|2.74||0.258|2-Sided|90.0|-7.64|1.42|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606537|NCT02647320|2950934|Other||LS Mean Difference|-0.1|Standard Error of the Mean|2.79||0.963|2-Sided|90.0|-4.73|4.48|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606538|NCT02647320|2950934|Other||LS Mean Difference|-0.9|Standard Error of the Mean|3.16||0.773|2-Sided|90.0|-6.14|4.31|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606539|NCT02647320|2950934|Other||LS Mean Difference|-4.6|Standard Error of the Mean|3.13||0.144|2-Sided|90.0|-9.76|0.58|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606540|NCT02647320|2950935|Other||LS Mean Difference|-0.43|Standard Error of the Mean|0.139||0.002|2-Sided|90.0|-0.655|-0.197|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606541|NCT02647320|2950935|Other||LS Mean Difference|-0.08|Standard Error of the Mean|0.14||0.566|2-Sided|90.0|-0.312|0.151|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606542|NCT02647320|2950935|Other||LS Mean Difference|0.11|Standard Error of the Mean|0.161||0.512|2-Sided|90.0|-0.16|0.371|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606543|NCT02647320|2950935|Other||LS Mean Difference|0.05|Standard Error of the Mean|0.157||0.755|2-Sided|90.0|-0.211|0.309|||Mixed Model Repeated Measure|||Difference in change at week 12|
1606544|NCT02646826|2951003|Superiority||||||<|0.44|||||||ANOVA||||
1606545|NCT02646826|2951004|Superiority|||||||0.0017|||||||ANOVA||||
1606546|NCT02646566|2951011|Superiority|||||||0.258|||||||Wilcoxon (Mann-Whitney)||||
1606547|NCT02646566|2951011|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1606548|NCT02646566|2951012|Superiority|||||||0.42|||||||Wilcoxon (Mann-Whitney)||||
1606549|NCT02646566|2951012|Superiority|||||||0.008|||||||Wilcoxon (Mann-Whitney)||||
1606550|NCT02646566|2951013|Superiority|||||||0.52|||||||Chi-squared||||
1606551|NCT02646566|2951013|Superiority|||||||0.065|||||||Chi-squared||||
1606552|NCT02646566|2951014|Superiority|||||||0.315|||||||Chi-squared||||
1606553|NCT02646566|2951014|Superiority|||||||0.009|||||||Chi-squared||||
1606554|NCT02646566|2951015|Superiority|||||||0.179|||||||Chi-squared||||
1606555|NCT02646566|2951015|Superiority||||||<|0.001|||||||Chi-squared||||
1606556|NCT02646566|2951016|Superiority|||||||0.004|||||||Chi-squared||||
1606557|NCT02646566|2951016|Superiority||||||<|0.001|||||||Chi-squared||||
1606558|NCT02646566|2951017|Superiority|||||||0.084|||||||Regression, Cox||||
1606559|NCT02646566|2951017|Superiority||||||<|0.001|||||||Regression, Cox||||
1606560|NCT02646566|2951018|Superiority|||||||0.021||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared||||
1606561|NCT02646566|2951018|Superiority||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared||||
1606562|NCT02646566|2951019|Superiority|||||||0.053||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared||||
1606563|NCT02646566|2951019|Superiority||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared||||
1606564|NCT02646566|2951020|Superiority|||||||0.059||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared||||
1606565|NCT02646566|2951020|Superiority||||||<|0.001||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared||||
1606599|NCT02643082|2951154|Superiority||LS Mean ratio between treatments|1.79|||<|0.0001|2-Sided|95.0|1.67|1.92|||Mixed Models Analysis||||
1607240|NCT02631070|2952234|Superiority|||||||0.5479|||||||Cochran-Mantel-Haenszel|||Week 1 -24|
1606566|NCT02646566|2951021|Superiority|||||||0.109||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.109) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson’s χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.|
1606567|NCT02646566|2951021|Superiority|||||||0.003||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.003) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson’s χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.|
1606568|NCT02645760|2951029|Superiority or Other|||||||0.012|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 0.30 centimeter in mean repositioning error between core stabilization exercise and conventional treatment from baseline to week 7.|
1606569|NCT02645760|2951030|Superiority or Other|||||||0.013|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 0.79 centimeter in mean range of motion between core stabilization exercise and conventional treatment from baseline to week 7.|
1606570|NCT02645760|2951031|Superiority or Other|||||||0.009|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 2.68 points in mean disability score (RMDQ score) between core stabilization exercise and conventional treatment from baseline to week 7.|
1606571|NCT02645760|2951032|Superiority or Other||||||<|0.001|||||||ANCOVA|||It was calculated that 38 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% power to detect a difference of 2.26 points in mean 11-point NRS pain score between core stabilization exercise and conventional treatment from baseline to week 7.|
1606572|NCT02645253|2951038|Superiority or Other||Ratio of Geometric LS mean (%)|75.38||||||95.0|63.4|89.61|||||Day 16 / Day -1||
1606573|NCT02645253|2951038|Superiority or Other||Ratio of Geometric LS mean (%)|99.82|||||2-Sided|95.0|84.12|118.46|||||Day 1 / Day -1||
1606574|NCT02645253|2951038|Superiority or Other||Ratio of Geometric LS mean (%)|89.44|||||2-Sided|95.0|75.35|106.16|||||Day 16 / Day -1||
1606575|NCT02645253|2951038|Superiority or Other||Ratio of Geometric LS mean (%)|105.92|||||2-Sided|95.0|89.4|125.49|||||Day 1 / Day -1||
1606576|NCT02645253|2951038|Superiority or Other||Ratio of Geometric LS mean (%)|91.82|||||2-Sided|95.0|77.32|109.04|||||Day 16 / Day -1||
1606577|NCT02645253|2951038|Superiority or Other||Ratio of Geometric LS mean (%)|102.99|||||2-Sided|95.0|86.88|122.09|||||Day 1/ Day -1||
1606578|NCT02645253|2951050|Superiority or Other||Slope|1.05|Standard Error of the Mean|0.0552|||2-Sided|90.0|0.951|1.14|||||||
1606579|NCT02645253|2951055|Superiority or Other||Slope|0.979|Standard Error of the Mean|0.0633|||2-Sided|90.0|0.87|1.09|||||||
1606580|NCT02645253|2951065|Superiority or Other||Slope|1.05|Standard Error of the Mean|0.119|||2-Sided|90.0|0.801|1.31|||||||
1606581|NCT02645253|2951067|Superiority or Other||Slope|1.14|Standard Error of the Mean|0.0503|||2-Sided|90.0|1.06|1.23|||||||
1606582|NCT02645253|2951069|Superiority or Other||Slope|1.02|Standard Error of the Mean|0.0785|||2-Sided|90.0|0.882|1.15|||||||
1606583|NCT02644096|2951106|Superiority or Other||||||<|0.05||||||Changes in physical function after 3 months|unpaired t-test|||"Power calculation in this study was based on findings in a previous cross-sectional study.~The physical dimensions in health status was the primary outcome variable. The mean physical score was 49.4, SD was 26.1; alpha in this study was set to 5% and β to 20%. We considered that the intervention could lead to an improvement of 50% in the physical health score and were willing to overlook a difference in score of 12. When the sample size was calculated, 68 patients were needed in both groups."|
1606584|NCT02643472|2951127|Superiority|||||||0.87|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Motor subscale.|
1606585|NCT02643472|2951127|Superiority|||||||0.58|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Language subscale.|
1606586|NCT02643472|2951127|Superiority|||||||0.92|||||||t-test, 2 sided|||Infant development status was evaluated with Bayley subscales. Cognitive subscale.|
1606587|NCT02643472|2951128|Superiority|||||||0.6|||||||Chi-squared||||
1606588|NCT02643472|2951129|Superiority|||||||0.64|||||||Wilcoxon (Mann-Whitney)||||
1606589|NCT02643472|2951130|Superiority|||||||0.43|||||||Wilcoxon (Mann-Whitney)||||
1606590|NCT02643472|2951131|Superiority|||||||0.06|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.|||
1606591|NCT02643472|2951134|Superiority|||||||0.03|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.|||
1606592|NCT02643472|2951135|Superiority|||||||0.12|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.||STAI Y-1 data was used in these statistical analyses.|
1606593|NCT02643472|2951136|Superiority|||||||0.73|||||||Generalized Estimating Equations|In analyzing predicted means, results of Generalized Estimating Equations (GEE) modeling controlled for time from baseline at each assessment.|||
1606594|NCT02643394|2951137|Superiority|||||||0.402|||||||Wilcoxon (Mann-Whitney)||||
1606595|NCT02643394|2951138|Superiority|||||||0.252|||||||Wilcoxon (Mann-Whitney)||||
1606596|NCT02643251|2951144|Superiority|||||||0.3361|||||||Mixed Models Analysis||||
1606597|NCT02643082|2951152|Superiority||LS Mean ratio between treatments|0.87|||<|0.0001|2-Sided|95.0|0.82|0.92|||Mixed Models Analysis||||
1606598|NCT02643082|2951153|Superiority||LS Mean Difference Between Treatments|0.443|||<|0.0001|2-Sided|95.0|0.318|0.569|||Mixed Models Analysis||||
1606600|NCT02643082|2951155|Superiority||LS Mean ratio between treatments|0.29|||<|0.0001|2-Sided|95.0|0.25|0.33|||Mixed Models Analysis||||
1606601|NCT02643082|2951156|Superiority||LS Mean ratio between treatments|0.29|||<|0.0001|2-Sided|95.0|0.26|0.33|||Mixed Models Analysis||||
1606602|NCT02643082|2951157|Superiority||LS Mean ratio between treatments|1.75|||<|0.0001|2-Sided|95.0|1.65|1.86|||Mixed Models Analysis||||
1606603|NCT02642679|2951211|Other|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we will have 95% power to detect an improvement of 2 points in VSS score assuming a common standard deviation of 1 point.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in healing quality. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values <0.05 were considered significant.
1606604|NCT02642679|2951212|Other|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we will have 80% power to detect an improvement in re-epithelialization from 14.6 days to 10 days assuming a common standard deviation of 2.9 days.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in healing rate. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values <0.05 were considered significant.
1606605|NCT02642679|2951213|Other|We set alpha=0.05/3=0.17 to account for multiple outcomes for sample size and power calculations. With 10 patients in each group, we had 95% power to detect an improvement of 2 points in VAS score assuming a common standard deviation of 1 point with a two sided two sample t-test each at alpha=0.17 level.|||||||||||||||||A student t-test was used for correlated samples to determine if there were significant differences in pain. Microsoft Excel 2010 (Microsoft Corp., Redmond, WA) was used for statistical analysis. Data that were considered normally distributed are reported as the mean ± standard deviation (SD) and percentage. P-values <0.05 were considered significant.
1606606|NCT02642614|2951236|Superiority or Other||Ratio of adjusted mean|1.44|Standard Error of the Mean|0.45||0.2398|2-Sided|90.0|0.86|2.41|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 100 milligram BI 1026706 divided by Placebo."|The adjusted means were calculated by exponentiating the LS means of the corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive PK sub-study participation and MBW sub-study participation)|
1606607|NCT02642614|2951236|Superiority or Other||Ratio of adjusted mean|1.58|Standard Error of the Mean|0.49||0.143|2-Sided|90.0|0.94|2.65|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 25 milligram BI 1026706 divided by Placebo."|The adjusted means were calculated by exponentiating the LS means of the corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive PK sub-study participation and MBW sub-study participation)|
1606608|NCT02642614|2951236|Superiority or Other||Ratio of adjusted mean|1.59|Standard Error of the Mean|0.51||0.154|2-Sided|90.0|0.93|2.72|||ANCOVA||"Standard Error of Mean is actually Standard Error of ratio of adjusted means, adjusted means ratio is calculated as 5 milligram BI 1026706 divided by Placebo."|Adjusted means were calculated by exponentiating Least Square (LS) means of corresponding values obtained from fitting an ANCOVA model to the natural log transformed endpoint variable, including treatment effect and study baseline as covariates, and adjusting for stratification factors (extensive pharmacokinetic (PK) sub-study participation and Multiple-breath washout (MBW) sub-study participation)|
1606609|NCT02642159|2951263|Superiority||Adjusted Mean Difference|9.0||||0.2651|2-Sided|97.5|-9.1|27.1||Threshold for significance <=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).|Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)
1606610|NCT02642159|2951264|Superiority||Adjusted Mean Difference|-4.2||||0.2191|2-Sided|97.5|-11.8|3.4||Threshold for significance <=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression.|Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).|
1606611|NCT02642159|2951265|Superiority||Adjusted Mean Difference|-22.8||||0.004|2-Sided|97.5|-40.6|-5.0||Threshold for significance <=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).|
1606612|NCT02642159|2951266|Superiority||Adjusted Mean Difference|-27.4|||<|0.0001|2-Sided|97.5|-34.6|-20.1||Threshold for significance <=0.025.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).|
1606613|NCT02642159|2951267|Superiority||LS Mean Difference|-25.3|||<|0.0001|2-Sided|97.5|-35.4|-15.1||Threshold for significance <=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).|
1606614|NCT02642159|2951268|Superiority||LS Mean Difference|-24.6|||<|0.0001|2-Sided|97.5|-28.8|-20.3||Threshold for significance <=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).|
1606700|NCT02638337|2951674|Superiority||LS Mean Difference|2.8|||<|0.0001|2-Sided|95.0|2.2|3.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12|
1607241|NCT02631070|2952235|Superiority|||||||0.5127|||||||Cochran-Mantel-Haenszel|||Week 1 - 48|
1606615|NCT02642159|2951269|Superiority||LS Mean Difference|-35.2|||<|0.0001|2-Sided|97.5|-47.4|-22.9||Threshold for significance <=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT- intent to prescribe fenofibrate stratum was statistically significant).|
1606616|NCT02642159|2951270|Superiority||LS Mean Difference|-32.3|||<|0.0001|2-Sided|97.5|-37.3|-27.2||Threshold for significance <=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).|
1606617|NCT02642159|2951271|Superiority||LS Mean Difference|-49.7|||<|0.0001|2-Sided|97.5|-63.7|-35.8||Threshold for significance <=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).|
1606618|NCT02642159|2951272|Superiority||LS Mean Difference|-34.7|||<|0.0001|2-Sided|97.5|-40.8|-28.6||Threshold for significance <=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).|
1606619|NCT02642159|2951273|Superiority||LS Mean Difference|-27.4|||<|0.0001|2-Sided|97.5|-40.0|-14.8||Threshold for significance <=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of ITT-intent to prescribe fenofibrate stratum was statistically significant).|
1606620|NCT02642159|2951274|Superiority||LS Mean Difference|-26.1|||<|0.0001|2-Sided|97.5|-31.5|-20.7||Threshold for significance <=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Testing according to the hierarchical testing procedure (only performed if the previous endpoint of overall ITT analysis was statistically significant).|
1606621|NCT02642159|2951275|Superiority||LS Mean Difference|-55.7|||<|0.0001|2-Sided|97.5|-71.8|-39.6||Threshold for significance <=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|A separate hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for ITT-intent to prescribe fenofibrate stratum. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.|
1606622|NCT02642159|2951276|Superiority||LS Mean Difference|-43.0|||<|0.0001|2-Sided|97.5|-49.7|-36.3||Threshold for significance <=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses for overall ITT analysis. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.|
1606623|NCT02642159|2951277|Superiority||LS Mean Difference|-33.3|||<|0.0001|2-Sided|97.5|-46.6|-19.9||Threshold for significance <=0.025.|Mixed Models Analysis||Alirocumab (intent to prescribe fenofibrate) vs. usual care (intent to prescribe fenofibrate)|Alirocumab group was compared to usual care group for the intent to prescribe fenofibrate using an appropriate contrast statement.|
1606624|NCT02642159|2951278|Superiority||LS Mean Difference|-32.5|||<|0.0001|2-Sided|97.5|-38.1|-27.0||Threshold for significance <=0.025.|Mixed Models Analysis||Alirocumab vs. usual care|Alirocumab group was compared to usual care group using an appropriate contrast statement.|
1606625|NCT02641912|2951310|Superiority or Other||Least sqaure (LS) mean difference|0.63||||0.0084|2-Sided|95.0|0.17|1.1|||ANOVA|From ANOVA model with factors for treatment and confirmed Sjögren’s syndrome status stratification using Observed Margins option.|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.||
1606626|NCT02641730|2951330|Superiority||Mean Difference (Final Values)|-4.11|Standard Error of the Mean|1.7||0.017|2-Sided|95.0|-7.468|-0.748|||Mixed-Model for Repeated Measures||||
1606627|NCT02641730|2951330|Superiority||Mean Difference (Final Values)|-7.69|Standard Error of the Mean|1.674|<|0.001|2-Sided|95.0|-11.0|-4.383|||Mixed-Model for Repeated Measures||||
1606628|NCT02641587|2951331|Other|"The analysis will test if the geometric LS mean level of Total NNAL for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC > 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|79.36|||<|0.001|2-Sided|95.0|72.73|84.39||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC [%]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of Total NNAL will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of Total NNAL.|
1606629|NCT02641587|2951332|Other|"The analysis will test if the geometric LS mean level of COHb for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC > 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|55.74|||<|0.001|2-Sided|95.0|49.03|61.56||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC [%]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of COHb will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of COHb.|
1606630|NCT02641587|2951333|Other|"The analysis will test if the geometric LS mean level of S-PMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC > 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|83.9|||<|0.001|2-Sided|95.0|81.61|85.9||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC [%]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of S-PMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of S-PMA.|
1606631|NCT02641587|2951334|Other|"The analysis will test if the geometric LS mean level of 3-HPMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC > 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|40.2|||<|0.001|2-Sided|95.0|30.25|48.73||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC [%]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of 3-HPMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of 3-HPMA.|
1606632|NCT02641587|2951335|Other|"The analysis will test if the geometric LS mean level of MHBMA for CHTP is lower than for CC. The following hypothesis will be evaluated:~H0: XCHTP - XCC ≤ 0.0~HA: XCHTP - XCC > 0.0~where XCHTP and XCC are the geometric LS means of CHTP and CC, respectively. H0 is rejected with a type I error α = 2.5% (one-sided test)."|LS Mean Reduction|85.01|||<|0.001|2-Sided|95.0|82.06|87.47||The primary endpoints will be tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|Generalized linear model||Least squares (LS) means and estimate of the difference, and 95% CI will be back-transformed for obtaining geometric LS means for each arm, the reduction (calculated as 100% - ratio of CHTP 1.2 : CC [%]), and their 95% CI.|Analysis will be conducted on the natural log scale. The Day 5 levels of MHBMA will be analyzed by means of a generalized linear model using randomized arm as covariate adjusting for sex, average cigarette consumption over the previous 6 weeks prior to Admission (value at Admission for stratification), and log-transformed baseline value of MHBMA.|
1606633|NCT02641561|2951336|Superiority|||||||0.04|||||||Fisher Exact||||
1606634|NCT02641379|2951372|Superiority or Other|||||||0.3031||||||The SVR rate i.e., 20.0% participants with genotype IV who achieved SVR with 95 % confidence interval of 0.5 to 71.6 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .|Cochran-Mantel-Haenszel|||Comparison of Groups A1+B1 versus group E stratified by genotype IV|
1606635|NCT02641379|2951372|Superiority or Other|||||||0.0021||||||The SVR rate i.e., 32.1% participants with genotype I who achieved SVR with 95 % confidence interval of 20.3 to 46.0 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .|Cochran-Mantel-Haenszel|||Comparison of Groups A1+B1 versus group E stratified by genotype I.|
1606636|NCT02641379|2951373|Superiority or Other|||||||1|||||||Chi-squared|||For Genotype IV, Week 4 response >= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.|
1606637|NCT02641379|2951373|Superiority or Other|||||||0.091|||||||Chi-squared|||For Genotype IV, Week 4 response < 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.|
1606638|NCT02641379|2951373|Superiority or Other|||||||0.0184|||||||Chi-squared|||For Genotype I, Week 4 response >= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.|
1606639|NCT02641379|2951373|Superiority or Other|||||||0.1002|||||||Chi-squared|||For Genotype I, Week 4 response < 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.|
1606640|NCT02641067|2951382|Other||Geometric mean ratio|0.83|||||2-Sided|90.0|0.61|1.15|||||||
1606641|NCT02641067|2951383|Other||Geometric mean ratio|1.38|||||2-Sided|90.0|0.99|1.92|||||||
1606642|NCT02641067|2951384|Other||Geometric mean ratio|1.43|||||2-Sided|90.0|1.0|2.04|||||||
1606643|NCT02640482|2951450|Superiority|The superiority of the rate of sustained virologic response at 12 weeks after treatment for Arm A as compared with the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 95% to achieve superiority.|Percentage of Participants|99.5|||||2-Sided|95.0|98.5|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96% in the Arm A (180 participants) provides >90% power to demonstrate superiority of ABT-493/ABT-530 to the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) (95%) (based on the normal approximation of a single binomial proportion using a one-sample test for superiority).|
1606644|NCT02640482|2951451|Non-Inferiority|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for Arm A as compared with the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.|Percentage of Participants|99.5|||||2-Sided|95.0|98.5|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥96% in the Arm A (180 participants) provides >90% power to demonstrate noninferiority of ABT-493/ABT-530 to the historical rate for patients treated with the current standard of care (SOF + RBV for 12 weeks) (95%) (based on the normal approximation of using a single binomial proportion a one-sample test for superiority).|
1606645|NCT02640157|2951459|Non-Inferiority|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Difference in percentage of participants|-0.4|||||2-Sided|97.5|-5.4|4.6|||||||
1606646|NCT02640157|2951459|Non-Inferiority|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Percentage of participants|94.9|||||2-Sided|97.5|91.0|98.8|||||||
1606647|NCT02640157|2951459|Non-Inferiority|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm C was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm C was below 92%.|Difference in percentage of participants|-0.4|||||2-Sided|95.0|-4.8|4.0||||||Difference in SVR12 rates (Arm C - Arm A)|
1606648|NCT02640157|2951460|Non-Inferiority|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|Difference in percentage of participants|-1.2|||||2-Sided|97.5|-6.2|3.7||||||Difference in SVR12 rates (Arm A - Arm B).|
1606649|NCT02640157|2951460|Non-Inferiority|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|percentage of participants|95.3|||||2-Sided|97.5|92.2|98.4|||||||
1606650|NCT02640157|2951460|Non-Inferiority|Noninferiority: a) the lower bound (LB) of the 95%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was >92%; or b) the LB of the 95%CI for the difference was below the non-inferiority margin of -6% and the LB of the 97.5%CI for the SVR12 rate within Arm A was >92%; or c) the LB of the 97.5%CI for the difference was above the non-inferiority margin of -6% and the LB of the 95%CI for the SVR12 rate within Arm A was below 92%.|Difference in percentage of participants|-1.2|||||2-Sided|95.0|-5.6|3.1||||||Difference in SVR12 rates (Arm A - Arm B).|
1606651|NCT02640053|2951461|Superiority|||||||0.67|||||||Wilcoxon (Mann-Whitney)||||
1606652|NCT02640053|2951462|Superiority|||||||0.62|||||||Wilcoxon (Mann-Whitney)||||
1606653|NCT02640053|2951463|Superiority|||||||0.76|||||||Wilcoxon (Mann-Whitney)||||
1606654|NCT02640053|2951464|Superiority|||||||0.41|||||||Wilcoxon (Mann-Whitney)||||
1606655|NCT02640053|2951465|Superiority|||||||0.32|||||||Wilcoxon (Mann-Whitney)||||
1606656|NCT02640053|2951466|Superiority|||||||0.39|||||||Wilcoxon (Mann-Whitney)||||
1606657|NCT02640053|2951467|Superiority|||||||0.72|||||||Wilcoxon (Mann-Whitney)||||
1606658|NCT02640053|2951468|Superiority|||||||0.26|||||||Wilcoxon (Mann-Whitney)||||
1606659|NCT02639338|2951603|Superiority|The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 83%.|||||<|0.001||||||The reported p-value was calculated. The statistical test was performed in SOF/VEL for 12 weeks at 0.05 significance level if and only if the statistical test performed in SOF/VEL/VOX for 8 weeks was significant at 0.05 significance level.|2-sided exact 1-sample binomial test||||
1606660|NCT02639338|2951603|Superiority|The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 83%.|||||<|0.001||||||The reported p-value was calculated. The statistical test was performed in SOF/VEL for 12 weeks at 0.05 significance level if and only if the statistical test performed in SOF/VEL/VOX for 8 weeks was significant at 0.05 significance level.|Binomial Test||||
1606661|NCT02639052|2951610|Superiority or Other|||||||0.1306||||||Statistical significance defined a priori as p<0.05.|ANOVA with Repeated Measures|||Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and visit, and interaction effect between treatment and visit.|
1606662|NCT02639052|2951611|Superiority or Other|||||||0.0004||||||Statistical significance defined a priori as p<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|Analyzed using ANOVA with repeated measures to compare treatment (Botox vs saline), time, and interaction effect between treatment & time||3 months (Visit 4) was the third assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.|
1606663|NCT02639052|2951612|Superiority or Other||||||<|0.0001||||||Statistically significant difference in mean itch VAS between the two treatments (Botox mean=2.45 versus saline mean=3.20, p<0.0001). Statistical significance defined a priori as p<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|||1 month (Visit 3) was the second assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.|
1606664|NCT02639052|2951613|Superiority or Other||||||<|0.0001||||||Statistical significance defined a priori as p<0.05. P-values have not been adjusted for multiple comparisons.|ANOVA with Repeated Measures|||1 week (Visit 2) was the first assessment of itch VAS after itch induction after Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.|
1606665|NCT02639052|2951614|Superiority or Other|||||||0.9704||||||Significance defined a priori as p<0.05. P-values not adjusted for multiple comparisons.|ANOVA with Repeated Measures|||Baseline assessment of itch VAS after itch induction but prior to Botox or saline application. Analyzed using ANOVA with repeated measures to compare main effects of treatment (Botox vs saline) and time, and interaction effect between treatment and time.|
1606666|NCT02638948|2951639|Superiority||Estimate of Difference (%)|-0.2||||1|2-Sided|95.0|-22.5|22.2||Threshold for significance = 0.05|Chi-squared||||
1606667|NCT02638948|2951639|Superiority||Estimate of Difference (%)|5.6||||0.2058|2-Sided|95.0|-10.5|21.9||Threshold for significance = 0.05|Chi-squared||||
1606668|NCT02638948|2951639|Superiority||Estimate of Difference (%)|0.1||||1|2-Sided|95.0|-16.0|16.5||Threshold for significance = 0.05|Chi-squared||||
1606669|NCT02638948|2951640|Superiority||Estimate of Difference (%)|0.1||||0.9922|2-Sided|95.0|-20.5|20.7||Threshold for significance = 0.05|Chi-squared||||
1606670|NCT02638948|2951640|Superiority||Estimate of Difference (%)|11.8||||0.136|2-Sided|95.0|-3.6|27.2||Threshold for significance = 0.05|Chi-squared||||
1606671|NCT02638948|2951640|Superiority||Estimate of Difference (%)|4.9||||0.5224|2-Sided|95.0|-10.2|20.1||Threshold for significance = 0.05|Chi-squared||||
1606672|NCT02638337|2951657|Superiority|||||||0.0007|||||||Wilcoxon rank-sum test||||
1606673|NCT02638337|2951658|Superiority|||||||0.8772|||||||Welch's t-test||||
1606674|NCT02638337|2951659|Superiority|||||||0.9575|||||||Welch's t-test||||
1606675|NCT02638337|2951660|Superiority||LS Mean Difference|-5.26|||<|0.0001|2-Sided|95.0|-7.64|-2.89|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.|||
1606676|NCT02638337|2951661|Superiority||LS Mean Difference|-2.06|||<|0.0001|2-Sided|95.0|-2.92|-1.19|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.|||
1606677|NCT02638337|2951662|Superiority||LS Mean Difference|-1.35||||0.0084|2-Sided|95.0|-2.35|-0.35|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.|||
1606678|NCT02638337|2951663|Superiority||LS Mean Difference|-6.2|||<|0.0001|2-Sided|95.0|-8.1|-4.3|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.|||
1606679|NCT02638337|2951664|Superiority||LS Mean Difference|-0.22||||0.0003|2-Sided|95.0|-0.34|-0.1|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.|||
1606680|NCT02638337|2951665|Superiority||LS Mean Difference|-0.75||||0.0227|2-Sided|95.0|-1.39|-0.1|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.|||
1606681|NCT02638337|2951666|Superiority||LS Mean Difference|-0.14||||0.5159|2-Sided|95.0|-0.58|0.29|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.|||
1606682|NCT02638337|2951667|Superiority||LS Mean Difference|-0.049|||<|0.0001|2-Sided|95.0|-0.071|-0.027|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.|||
1606683|NCT02638337|2951668|Superiority||LS Mean Difference|-4388.3||||0.4263|2-Sided|95.0|-15214.8|6438.3|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.|||
1606684|NCT02638337|2951669|Superiority||LS Mean Difference|0.3||||0.2448|2-Sided|95.0|-0.2|0.9|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12|
1606685|NCT02638337|2951669|Superiority||LS Mean Difference|0.4||||0.1104|2-Sided|95.0|-0.1|0.9|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8|
1606686|NCT02638337|2951669|Superiority||LS Mean Difference|0.1||||0.723|2-Sided|95.0|-0.4|0.6|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4|
1606687|NCT02638337|2951670|Superiority||LS Mean Difference|0.45||||0.0103|2-Sided|95.0|0.11|0.8|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Pain|
1606688|NCT02638337|2951670|Superiority||LS Mean Difference|0.16||||0.2195|2-Sided|95.0|-0.1|0.41|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Satisfaction|
1606689|NCT02638337|2951670|Superiority||LS Mean Difference|0.16||||0.34|2-Sided|95.0|-0.16|0.48|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Orgasm|
1606690|NCT02638337|2951670|Superiority||LS Mean Difference|0.4||||0.0161|2-Sided|95.0|0.07|0.73|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Lubrication|
1606691|NCT02638337|2951670|Superiority||LS Mean Difference|0.2||||0.1867|2-Sided|95.0|-0.1|0.49|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Arousal|
1606692|NCT02638337|2951670|Superiority||LS Mean Difference|0.16||||0.0752|2-Sided|95.0|-0.02|0.34|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Desire|
1606693|NCT02638337|2951671|Superiority||LS Mean Difference|1.59||||0.0392|2-Sided|95.0|0.08|3.09|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12|
1606694|NCT02638337|2951671|Superiority||LS Mean Difference|0.19||||0.7865|2-Sided|95.0|-1.18|1.56|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8|
1606695|NCT02638337|2951671|Superiority||LS Mean Difference|0.02||||0.9748|2-Sided|95.0|-1.17|1.2|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4|
1606696|NCT02638337|2951672|Superiority||LS Mean Difference|-1.0||||0.0118|2-Sided|95.0|-1.8|-0.2|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.|||
1606697|NCT02638337|2951673|Superiority||LS Mean Difference|-1.2|||<|0.0001|2-Sided|95.0|-1.6|-0.7|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12|
1606698|NCT02638337|2951673|Superiority||LS Mean Difference|-1.1|||<|0.0001|2-Sided|95.0|-1.5|-0.6|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8|
1606699|NCT02638337|2951673|Superiority||LS Mean Difference|-0.8|||<|0.0002|2-Sided|95.0|-1.3|-0.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4|
1606701|NCT02638337|2951674|Superiority||LS Mean Difference|2.9|||<|0.0001|2-Sided|95.0|2.4|3.4|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8|
1606702|NCT02638337|2951674|Superiority||LS Mean Difference|2.5|||<|0.0001|2-Sided|95.0|2.0|3.0|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4|
1606703|NCT02638337|2951675|Superiority||||||<|0.0001|||||||Fisher Exact|||Week 12|
1606704|NCT02638337|2951675|Superiority||||||<|0.0001|||||||Fisher Exact|||Week 8|
1606705|NCT02638337|2951675|Superiority||||||<|0.0001|||||||Fisher Exact|||Week 4|
1606706|NCT02638337|2951676|Superiority||LS Mean Difference|14.91|||<|0.0001|2-Sided|95.0|12.55|17.28|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 12|
1606707|NCT02638337|2951676|Superiority||LS Mean Difference|14.73|||<|0.0001|2-Sided|95.0|12.5|16.96|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 8|
1606708|NCT02638337|2951676|Superiority||LS Mean Difference|13.98|||<|0.0001|2-Sided|95.0|11.85|16.12|||ANCOVA|The ANCOVA model included treatment group as a fixed effect and baseline value as a covariate.||Week 4|
1606709|NCT02638337|2951677|Superiority||Odds Ratio (OR)|0.86||||0.7101|2-Sided|95.0|0.39|1.89|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12|
1606710|NCT02638337|2951677|Superiority||Odds Ratio (OR)|0.88||||0.7672|2-Sided|95.0|0.37|2.08|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8|
1606711|NCT02638337|2951677|Superiority||Odds Ratio (OR)|0.71||||0.4336|2-Sided|95.0|0.3|1.67|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4|
1606712|NCT02638337|2951678|Superiority||Odds Ratio (OR)|1.97||||0.0004|2-Sided|95.0|1.35|2.88|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12|
1606713|NCT02638337|2951678|Superiority||Odds Ratio (OR)|1.45||||0.0542|2-Sided|95.0|0.99|2.11|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8|
1606714|NCT02638337|2951678|Superiority||Odds Ratio (OR)|1.65||||0.0095|2-Sided|95.0|1.13|2.4|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4|
1606715|NCT02638337|2951679|Superiority||Odds Ratio (OR)|1.33||||0.5391|2-Sided|95.0|0.54|3.26|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12|
1606716|NCT02638337|2951679|Superiority||Odds Ratio (OR)|1.51||||0.397|2-Sided|95.0|0.58|3.95|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8|
1606717|NCT02638337|2951679|Superiority||Odds Ratio (OR)|0.92||||0.8369|2-Sided|95.0|0.4|2.1|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4|
1606718|NCT02638337|2951680|Superiority||Odds Ratio (OR)|1.03||||0.8894|2-Sided|95.0|0.65|1.64|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 12|
1606719|NCT02638337|2951680|Superiority||Odds Ratio (OR)|1.07||||0.7869|2-Sided|95.0|0.66|1.75|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8|
1606720|NCT02638337|2951680|Superiority||Odds Ratio (OR)|0.89||||0.6263|2-Sided|95.0|0.55|1.43|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4|
1606721|NCT02638337|2951681|Superiority||Odds Ratio (OR)|2.01|||<|0.0001|2-Sided|95.0|1.47|2.74|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 8|
1606722|NCT02638337|2951681|Superiority||Odds Ratio (OR)|1.74|||<|0.0005|2-Sided|95.0|1.27|2.36|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|Week 4|
1606723|NCT02638337|2951682|Superiority||LS Mean Difference|-0.63|||<|0.0001|2-Sided|95.0|-0.75|-0.51|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8|
1606724|NCT02638337|2951682|Superiority||LS Mean Difference|-0.58|||<|0.0001|2-Sided|95.0|-0.69|-0.46|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4|
1607151|NCT02634073|2952051|Superiority or Other||Ratio|1.571|||||2-Sided|90.0|1.466|1.684|||||||
1606725|NCT02638337|2951683|Superiority||LS Mean Difference|7.2|||<|0.0001|2-Sided|95.0|5.5|9.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8|
1606726|NCT02638337|2951683|Superiority||LS Mean Difference|5.8|||<|0.0001|2-Sided|95.0|4.2|7.3|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4|
1606727|NCT02638337|2951684|Superiority||LS Mean Difference|-21.8|||<|0.0001|2-Sided|95.0|-25.4|-18.1|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 8|
1606728|NCT02638337|2951684|Superiority||LS Mean Difference|-21.6|||<|0.0001|2-Sided|95.0|-25.2|-18.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||Week 4|
1606729|NCT02638337|2951686|Superiority||Odds Ratio (OR)|2.23|||<|0.0001|2-Sided|95.0|1.62|3.06|||Generalized estimating equations model|GEE model with treatment, week, treatment by week interaction, and study center as fixed effects and baseline severity of dryness as a covariate.|Odds ratio is the exponential of the mean of cumulative log odds ratio.|For the MBS of vaginal dryness a generalized estimating equations (GEE) model was used to fit a marginal proportional odds model to the longitudinal ordered categorical data, with repeated measurements of the change from baseline as the response variable; treatment, week, treatment by week interaction, and study center as fixed effects; and baseline severity of dryness modeled as a covariate.|
1606730|NCT02638337|2951687|Superiority||LS Mean Difference|-0.72|||<|0.0001|2-Sided|95.0|-0.84|-0.59|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.|||
1606731|NCT02638337|2951688|Superiority||LS Mean Difference|7.2|||<|0.0001|2-Sided|95.0|5.2|9.1|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.|||
1606732|NCT02638337|2951689|Superiority||LS Mean Difference|-21.8|||<|0.0001|2-Sided|95.0|-25.7|-18.0|||Mixed-effects model repeated measures|MMRM model with treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.||For the percentage of parabasal cells a mixed-effects model for repeated measures (MMRM) approach was used, with repeated measurements of the change from baseline as the response variable; treatment, week, treatment by week interaction, and study center as fixed effects; and baseline value modeled as a covariate.|
1606733|NCT02638259|2951722|Equivalence|A margin of 0.6 can be statistically and clinically justified based on the results Keystone et al, Arthritis and Rheumatism, p353-363, (2004) and on the EULAR response criteria. The sample size of 155 per group with 90% power is based on the common SD of 1.46 and was calculated using nQuery 7.0.|Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.097|||2-Sided|95.0|-0.26|0.12||||||Therapeutic equivalence in terms of change from baseline in DAS28-CRP at week 24 will be concluded if the 95% confidence interval for the LS mean difference between GP2015 and Enbrel is contained within the interval [-0.6; 0.6]. A mixed-model repeated measures analysis was performed for DAS28-CRP change from baseline including treatment, stratification factors, time, the interaction between time (visits) and treatment all as categorical variables, and baseline DAS28-CRP as a continuous variable.|
1606734|NCT02638051|2951752|Superiority or Other||||||>|0.05|||||||Chi-squared|||"Applies to Worse QoL"|
1606735|NCT02638051|2951752|Superiority or Other||||||>|0.0527|||||||Chi-squared|||"Applies to No Change"|
1606736|NCT02638051|2951752|Superiority or Other||||||>|0.0053|||||||Chi-squared|||"Applies to Better QoL"|
1606737|NCT02638051|2951753|Superiority or Other|||||||0.0215|||||||Chi-squared|||"Applies to Bone marrow depression"|
1606738|NCT02638051|2951753|Superiority or Other||||||>|0.05|||||||Chi-squared|||"Applies to Damage of hepatic or renal function"|
1606739|NCT02638051|2951753|Superiority or Other||||||>|0.05|||||||Chi-squared|||"Applies to Gastrointestinal reactions"|
1606740|NCT02638051|2951753|Superiority or Other||||||>|0.05|||||||Chi-squared|||"Applies to Abdominal pain rate"|
1606741|NCT02638051|2951753|Superiority or Other||||||>|0.0016|||||||Chi-squared|||"Applies to All Adverse Events rate"|
1606742|NCT02638051|2951754|Superiority or Other|||||||0.014|||||||Chi-squared|||"Applies to Objective Response Rate (ORR)"|
1606743|NCT02637557|2951806|Superiority||LS Mean Difference|0.1||||0.0527|2-Sided|95.0|-0.001|0.201||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1606744|NCT02637557|2951806|Superiority||LS Mean Difference|-0.008||||0.8829|2-Sided|95.0|-0.109|0.094||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1606745|NCT02637557|2951806|Superiority||LS Mean Difference|0.0||||0.9961|2-Sided|95.0|-0.1|0.101||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1606746|NCT02637557|2951807|Superiority||LS Mean Difference|0.07||||0.3106|2-Sided|95.0|-0.066|0.207||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1606747|NCT02637557|2951807|Superiority||LS Mean Difference|0.034||||0.6287|2-Sided|95.0|-0.103|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1606748|NCT02637557|2951807|Superiority||LS Mean Difference|-0.02||||0.7689|2-Sided|95.0|-0.155|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1606749|NCT02637557|2951808|Superiority||LS Mean Difference|-0.199||||0.1706|2-Sided|95.0|-0.485|0.086||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606750|NCT02637557|2951808|Superiority||LS Mean Difference|-0.112||||0.4356|2-Sided|95.0|-0.393|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606751|NCT02637557|2951808|Superiority||LS Mean Difference|-0.164||||0.2523|2-Sided|95.0|-0.445|0.117||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606752|NCT02637557|2951808|Superiority||LS Mean Difference|-0.099||||0.4848|2-Sided|95.0|-0.376|0.179||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606753|NCT02637557|2951808|Superiority||LS Mean Difference|0.008||||0.9565|2-Sided|95.0|-0.266|0.281||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606754|NCT02637557|2951808|Superiority||LS Mean Difference|-0.085||||0.5388|2-Sided|95.0|-0.359|0.188||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606755|NCT02637557|2951808|Superiority||LS Mean Difference|-0.141||||0.2923|2-Sided|95.0|-0.404|0.122||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606756|NCT02637557|2951808|Superiority||LS Mean Difference|-0.043||||0.7423|2-Sided|95.0|-0.303|0.216||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606757|NCT02637557|2951808|Superiority||LS Mean Difference|-0.044||||0.7384|2-Sided|95.0|-0.304|0.215||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606758|NCT02637557|2951808|Superiority||LS Mean Difference|-0.166||||0.2014|2-Sided|95.0|-0.421|0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606759|NCT02637557|2951808|Superiority||LS Mean Difference|-0.069||||0.5897|2-Sided|95.0|-0.321|0.183||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606760|NCT02637557|2951808|Superiority||LS Mean Difference|-0.088||||0.4932|2-Sided|95.0|-0.339|0.164||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606761|NCT02637557|2951808|Superiority||LS Mean Difference|-0.165||||0.2064|2-Sided|95.0|-0.422|0.092||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606762|NCT02637557|2951808|Superiority||LS Mean Difference|-0.096||||0.4572|2-Sided|95.0|-0.349|0.158||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606763|NCT02637557|2951808|Superiority||LS Mean Difference|-0.093||||0.4717|2-Sided|95.0|-0.346|0.161||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606764|NCT02637557|2951808|Superiority||LS Mean Difference|-0.149||||0.2189|2-Sided|95.0|-0.388|0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606765|NCT02637557|2951808|Superiority||LS Mean Difference|-0.129||||0.2821|2-Sided|95.0|-0.364|0.106||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606766|NCT02637557|2951808|Superiority||LS Mean Difference|-0.101||||0.401|2-Sided|95.0|-0.336|0.135||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606767|NCT02637557|2951808|Superiority||LS Mean Difference|0.055||||0.6429|2-Sided|95.0|-0.179|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606768|NCT02637557|2951808|Superiority||LS Mean Difference|0.113||||0.3354|2-Sided|95.0|-0.118|0.344||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606769|NCT02637557|2951808|Superiority||LS Mean Difference|0.021||||0.8598|2-Sided|95.0|-0.21|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606770|NCT02637557|2951808|Superiority||LS Mean Difference|0.043||||0.6697|2-Sided|95.0|-0.155|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606771|NCT02637557|2951808|Superiority||LS Mean Difference|0.15||||0.1327|2-Sided|95.0|-0.046|0.345||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606772|NCT02637557|2951808|Superiority||LS Mean Difference|0.043||||0.6653|2-Sided|95.0|-0.152|0.238||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606773|NCT02637557|2951809|Superiority||LS Mean Difference|-0.433||||0.0015|2-Sided|95.0|-0.699|-0.168||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1607152|NCT02634073|2952051|Superiority or Other||Ratio|1.478|||||2-Sided|90.0|1.386|1.576|||||||
1606774|NCT02637557|2951809|Superiority||LS Mean Difference|-0.164||||0.2205|2-Sided|95.0|-0.427|0.099||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606775|NCT02637557|2951809|Superiority||LS Mean Difference|-0.093||||0.4881|2-Sided|95.0|-0.355|0.17||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606776|NCT02637557|2951809|Superiority||LS Mean Difference|-0.311||||0.0241|2-Sided|95.0|-0.581|-0.041||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606777|NCT02637557|2951809|Superiority||LS Mean Difference|-0.152||||0.2627|2-Sided|95.0|-0.419|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606778|NCT02637557|2951809|Superiority||LS Mean Difference|-0.095||||0.4841|2-Sided|95.0|-0.362|0.172||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606779|NCT02637557|2951809|Superiority||LS Mean Difference|-0.278||||0.0338|2-Sided|95.0|-0.534|-0.021||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606780|NCT02637557|2951809|Superiority||LS Mean Difference|-0.106||||0.4123|2-Sided|95.0|-0.359|0.148||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606781|NCT02637557|2951809|Superiority||LS Mean Difference|-0.059||||0.6471|2-Sided|95.0|-0.312|0.194||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606782|NCT02637557|2951809|Superiority||LS Mean Difference|-0.306||||0.0243|2-Sided|95.0|-0.571|-0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606783|NCT02637557|2951809|Superiority||LS Mean Difference|-0.142||||0.2892|2-Sided|95.0|-0.405|0.121||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606784|NCT02637557|2951809|Superiority||LS Mean Difference|-0.152||||0.2543|2-Sided|95.0|-0.415|0.11||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606785|NCT02637557|2951809|Superiority||LS Mean Difference|-0.295||||0.0203|2-Sided|95.0|-0.544|-0.046||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606786|NCT02637557|2951809|Superiority||LS Mean Difference|-0.188||||0.1343|2-Sided|95.0|-0.434|0.058||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606787|NCT02637557|2951809|Superiority||LS Mean Difference|-0.169||||0.1769|2-Sided|95.0|-0.415|0.077||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606788|NCT02637557|2951809|Superiority||LS Mean Difference|-0.252||||0.0325|2-Sided|95.0|-0.483|-0.021||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606789|NCT02637557|2951809|Superiority||LS Mean Difference|-0.116||||0.3175|2-Sided|95.0|-0.345|0.112||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606790|NCT02637557|2951809|Superiority||LS Mean Difference|-0.128||||0.2716|2-Sided|95.0|-0.356|0.1||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606791|NCT02637557|2951809|Superiority||LS Mean Difference|0.001||||0.9939|2-Sided|95.0|-0.224|0.226||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606792|NCT02637557|2951809|Superiority||LS Mean Difference|0.087||||0.4404|2-Sided|95.0|-0.135|0.31||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606793|NCT02637557|2951809|Superiority||LS Mean Difference|0.103||||0.3627|2-Sided|95.0|-0.119|0.326||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606794|NCT02637557|2951809|Superiority||LS Mean Difference|0.022||||0.8055|2-Sided|95.0|-0.156|0.201||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606795|NCT02637557|2951809|Superiority||LS Mean Difference|0.084||||0.3483|2-Sided|95.0|-0.092|0.261||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606796|NCT02637557|2951809|Superiority||LS Mean Difference|0.088||||0.3258|2-Sided|95.0|-0.088|0.265||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606797|NCT02637557|2951810|Superiority||LS Mean Difference|-0.267||||0.0471|2-Sided|95.0|-0.531|-0.003||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1607153|NCT02634073|2952051|Superiority or Other||Ratio|1.17|||||2-Sided|90.0|1.094|1.251|||||||
1606798|NCT02637557|2951810|Superiority||LS Mean Difference|-0.176||||0.1843|2-Sided|95.0|-0.437|0.084||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606799|NCT02637557|2951810|Superiority||LS Mean Difference|-0.043||||0.7466|2-Sided|95.0|-0.304|0.218||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606800|NCT02637557|2951810|Superiority||LS Mean Difference|-0.159||||0.2345|2-Sided|95.0|-0.421|0.103||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606801|NCT02637557|2951810|Superiority||LS Mean Difference|-0.052||||0.6916|2-Sided|95.0|-0.312|0.207||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606802|NCT02637557|2951810|Superiority||LS Mean Difference|-0.017||||0.8955|2-Sided|95.0|-0.277|0.242||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606803|NCT02637557|2951810|Superiority||LS Mean Difference|-0.228||||0.0833|2-Sided|95.0|-0.485|0.03||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606804|NCT02637557|2951810|Superiority||LS Mean Difference|-0.139||||0.2849|2-Sided|95.0|-0.394|0.116||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606805|NCT02637557|2951810|Superiority||LS Mean Difference|-0.096||||0.4611|2-Sided|95.0|-0.351|0.16||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606806|NCT02637557|2951810|Superiority||LS Mean Difference|-0.156||||0.2151|2-Sided|95.0|-0.403|0.091||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606807|NCT02637557|2951810|Superiority||LS Mean Difference|-0.061||||0.6243|2-Sided|95.0|-0.306|0.184||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606808|NCT02637557|2951810|Superiority||LS Mean Difference|-0.052||||0.6764|2-Sided|95.0|-0.297|0.193||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606809|NCT02637557|2951810|Superiority||LS Mean Difference|-0.155||||0.2225|2-Sided|95.0|-0.405|0.095||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606810|NCT02637557|2951810|Superiority||LS Mean Difference|-0.096||||0.4466|2-Sided|95.0|-0.343|0.152||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606811|NCT02637557|2951810|Superiority||LS Mean Difference|-0.05||||0.6936|2-Sided|95.0|-0.297|0.198||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606812|NCT02637557|2951810|Superiority||LS Mean Difference|-0.183||||0.1177|2-Sided|95.0|-0.412|0.046||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606813|NCT02637557|2951810|Superiority||LS Mean Difference|-0.151||||0.1906|2-Sided|95.0|-0.378|0.076||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606814|NCT02637557|2951810|Superiority||LS Mean Difference|-0.115||||0.3173|2-Sided|95.0|-0.342|0.111||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606815|NCT02637557|2951810|Superiority||LS Mean Difference|-0.045||||0.7024|2-Sided|95.0|-0.279|0.188||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606816|NCT02637557|2951810|Superiority||LS Mean Difference|0.062||||0.5971|2-Sided|95.0|-0.169|0.293||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606817|NCT02637557|2951810|Superiority||LS Mean Difference|0.099||||0.4022|2-Sided|95.0|-0.133|0.33||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606818|NCT02637557|2951810|Superiority||LS Mean Difference|-0.028||||0.775|2-Sided|95.0|-0.221|0.165||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606819|NCT02637557|2951810|Superiority||LS Mean Difference|0.1||||0.3021|2-Sided|95.0|-0.091|0.292||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606820|NCT02637557|2951810|Superiority||LS Mean Difference|0.128||||0.1902|2-Sided|95.0|-0.064|0.319||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606821|NCT02637557|2951811|Superiority||LS Mean Difference|-0.38||||0.0039|2-Sided|95.0|-0.637|-0.123||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1607154|NCT02634073|2952052|Superiority or Other||Ratio|1.29|||||2-Sided|90.0|1.04|1.61|||||||
1606822|NCT02637557|2951811|Superiority||LS Mean Difference|-0.218||||0.0913|2-Sided|95.0|-0.472|0.035||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606823|NCT02637557|2951811|Superiority||LS Mean Difference|-0.14||||0.2804|2-Sided|95.0|-0.395|0.115||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606824|NCT02637557|2951811|Superiority||LS Mean Difference|-0.285||||0.0271|2-Sided|95.0|-0.538|-0.033||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606825|NCT02637557|2951811|Superiority||LS Mean Difference|-0.071||||0.5759|2-Sided|95.0|-0.321|0.179||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606826|NCT02637557|2951811|Superiority||LS Mean Difference|-0.103||||0.4172|2-Sided|95.0|-0.354|0.147||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606827|NCT02637557|2951811|Superiority||LS Mean Difference|-0.259||||0.0434|2-Sided|95.0|-0.51|-0.008||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606828|NCT02637557|2951811|Superiority||LS Mean Difference|-0.105||||0.4071|2-Sided|95.0|-0.353|0.144||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606829|NCT02637557|2951811|Superiority||LS Mean Difference|-0.102||||0.4236|2-Sided|95.0|-0.351|0.148||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606830|NCT02637557|2951811|Superiority||LS Mean Difference|-0.27||||0.0294|2-Sided|95.0|-0.512|-0.027||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606831|NCT02637557|2951811|Superiority||LS Mean Difference|-0.108||||0.3739|2-Sided|95.0|-0.348|0.131||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606832|NCT02637557|2951811|Superiority||LS Mean Difference|-0.111||||0.3652|2-Sided|95.0|-0.352|0.13||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606833|NCT02637557|2951811|Superiority||LS Mean Difference|-0.215||||0.0885|2-Sided|95.0|-0.463|0.033||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606834|NCT02637557|2951811|Superiority||LS Mean Difference|-0.068||||0.5824|2-Sided|95.0|-0.313|0.176||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606835|NCT02637557|2951811|Superiority||LS Mean Difference|-0.086||||0.4903|2-Sided|95.0|-0.332|0.16||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606836|NCT02637557|2951811|Superiority||LS Mean Difference|-0.298||||0.0132|2-Sided|95.0|-0.534|-0.063||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606837|NCT02637557|2951811|Superiority||LS Mean Difference|-0.21||||0.0758|2-Sided|95.0|-0.443|0.022||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606838|NCT02637557|2951811|Superiority||LS Mean Difference|-0.203||||0.0887|2-Sided|95.0|-0.436|0.031||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606839|NCT02637557|2951811|Superiority||LS Mean Difference|-0.127||||0.2771|2-Sided|95.0|-0.356|0.102||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606840|NCT02637557|2951811|Superiority||LS Mean Difference|0.051||||0.6595|2-Sided|95.0|-0.176|0.277||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606841|NCT02637557|2951811|Superiority||LS Mean Difference|0.01||||0.9308|2-Sided|95.0|-0.217|0.238||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606842|NCT02637557|2951811|Superiority||LS Mean Difference|-0.028||||0.7671|2-Sided|95.0|-0.216|0.159||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606843|NCT02637557|2951811|Superiority||LS Mean Difference|0.143||||0.1295|2-Sided|95.0|-0.042|0.328||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606844|NCT02637557|2951811|Superiority||LS Mean Difference|0.098||||0.3007|2-Sided|95.0|-0.088|0.284||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606845|NCT02637557|2951812|Superiority||LS Mean Difference|-0.545||||0.0004|2-Sided|95.0|-0.843|-0.246||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1607155|NCT02634073|2952052|Superiority or Other||Ratio|1.53|||||2-Sided|90.0|1.25|1.88|||||||
1606846|NCT02637557|2951812|Superiority||LS Mean Difference|-0.336||||0.0262|2-Sided|95.0|-0.632|-0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606847|NCT02637557|2951812|Superiority||LS Mean Difference|-0.093||||0.5346|2-Sided|95.0|-0.388|0.202||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606848|NCT02637557|2951812|Superiority||LS Mean Difference|-0.469||||0.0034|2-Sided|95.0|-0.781|-0.157||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606849|NCT02637557|2951812|Superiority||LS Mean Difference|-0.377||||0.017|2-Sided|95.0|-0.687|-0.068||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606850|NCT02637557|2951812|Superiority||LS Mean Difference|-0.094||||0.5482|2-Sided|95.0|-0.403|0.214||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606851|NCT02637557|2951812|Superiority||LS Mean Difference|-0.392||||0.0105|2-Sided|95.0|-0.691|-0.093||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606852|NCT02637557|2951812|Superiority||LS Mean Difference|-0.319||||0.035|2-Sided|95.0|-0.616|-0.023||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606853|NCT02637557|2951812|Superiority||LS Mean Difference|-0.037||||0.8046|2-Sided|95.0|-0.333|0.258||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606854|NCT02637557|2951812|Superiority||LS Mean Difference|-0.355||||0.0193|2-Sided|95.0|-0.652|-0.058||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606855|NCT02637557|2951812|Superiority||LS Mean Difference|-0.223||||0.1365|2-Sided|95.0|-0.518|0.071||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606856|NCT02637557|2951812|Superiority||LS Mean Difference|-0.076||||0.6124|2-Sided|95.0|-0.369|0.218||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606857|NCT02637557|2951812|Superiority||LS Mean Difference|-0.384||||0.0064|2-Sided|95.0|-0.66|-0.109||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606858|NCT02637557|2951812|Superiority||LS Mean Difference|-0.348||||0.0128|2-Sided|95.0|-0.621|-0.075||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606859|NCT02637557|2951812|Superiority||LS Mean Difference|-0.127||||0.3586|2-Sided|95.0|-0.399|0.145||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606860|NCT02637557|2951812|Superiority||LS Mean Difference|-0.357||||0.0066|2-Sided|95.0|-0.613|-0.1||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606861|NCT02637557|2951812|Superiority||LS Mean Difference|-0.212||||0.102|2-Sided|95.0|-0.466|0.042||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606862|NCT02637557|2951812|Superiority||LS Mean Difference|-0.08||||0.5334|2-Sided|95.0|-0.333|0.173||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606863|NCT02637557|2951812|Superiority||LS Mean Difference|-0.015||||0.9086|2-Sided|95.0|-0.28|0.249||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606864|NCT02637557|2951812|Superiority||LS Mean Difference|-0.034||||0.7959|2-Sided|95.0|-0.296|0.228||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606865|NCT02637557|2951812|Superiority||LS Mean Difference|0.073||||0.5845|2-Sided|95.0|-0.189|0.334||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606866|NCT02637557|2951812|Superiority||LS Mean Difference|0.037||||0.7394|2-Sided|95.0|-0.181|0.254||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606867|NCT02637557|2951812|Superiority||LS Mean Difference|0.072||||0.5091|2-Sided|95.0|-0.143|0.288||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606868|NCT02637557|2951812|Superiority||LS Mean Difference|0.143||||0.1922|2-Sided|95.0|-0.072|0.357||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606869|NCT02637557|2951813|Superiority||LS Mean Difference|-0.482||||0.0019|2-Sided|95.0|-0.785|-0.18||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1607156|NCT02634073|2952052|Superiority or Other||Ratio|1.37|||||2-Sided|90.0|1.11|1.69|||||||
1606870|NCT02637557|2951813|Superiority||LS Mean Difference|-0.35||||0.0222|2-Sided|95.0|-0.65|-0.05||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606871|NCT02637557|2951813|Superiority||LS Mean Difference|-0.079||||0.6033|2-Sided|95.0|-0.378|0.22||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606872|NCT02637557|2951813|Superiority||LS Mean Difference|-0.484||||0.0023|2-Sided|95.0|-0.793|-0.175||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606873|NCT02637557|2951813|Superiority||LS Mean Difference|-0.29||||0.064|2-Sided|95.0|-0.596|0.017||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606874|NCT02637557|2951813|Superiority||LS Mean Difference|-0.056||||0.7187|2-Sided|95.0|-0.362|0.25||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606875|NCT02637557|2951813|Superiority||LS Mean Difference|-0.345||||0.0273|2-Sided|95.0|-0.652|-0.039||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606876|NCT02637557|2951813|Superiority||LS Mean Difference|-0.373||||0.0163|2-Sided|95.0|-0.677|-0.069||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606877|NCT02637557|2951813|Superiority||LS Mean Difference|-0.06||||0.6985|2-Sided|95.0|-0.363|0.243||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606878|NCT02637557|2951813|Superiority||LS Mean Difference|-0.255||||0.0951|2-Sided|95.0|-0.554|0.045||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606879|NCT02637557|2951813|Superiority||LS Mean Difference|-0.282||||0.0623|2-Sided|95.0|-0.579|0.015||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606880|NCT02637557|2951813|Superiority||LS Mean Difference|-0.096||||0.5232|2-Sided|95.0|-0.392|0.2||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606881|NCT02637557|2951813|Superiority||LS Mean Difference|-0.328||||0.0244|2-Sided|95.0|-0.614|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606882|NCT02637557|2951813|Superiority||LS Mean Difference|-0.336||||0.02|2-Sided|95.0|-0.62|-0.053||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606883|NCT02637557|2951813|Superiority||LS Mean Difference|-0.126||||0.38|2-Sided|95.0|-0.409|0.156||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606884|NCT02637557|2951813|Superiority||LS Mean Difference|-0.252||||0.0635|2-Sided|95.0|-0.519|0.014||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606885|NCT02637557|2951813|Superiority||LS Mean Difference|-0.27||||0.0452|2-Sided|95.0|-0.534|-0.006||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606886|NCT02637557|2951813|Superiority||LS Mean Difference|-0.048||||0.7193|2-Sided|95.0|-0.312|0.216||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606887|NCT02637557|2951813|Superiority||LS Mean Difference|-0.062||||0.6288|2-Sided|95.0|-0.313|0.19||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606888|NCT02637557|2951813|Superiority||LS Mean Difference|-0.122||||0.3348|2-Sided|95.0|-0.372|0.127||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606889|NCT02637557|2951813|Superiority||LS Mean Difference|0.067||||0.5987|2-Sided|95.0|-0.182|0.315||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606890|NCT02637557|2951813|Superiority||LS Mean Difference|-0.077||||0.4596|2-Sided|95.0|-0.283|0.129||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606891|NCT02637557|2951813|Superiority||LS Mean Difference|-0.071||||0.4946|2-Sided|95.0|-0.275|0.133||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606892|NCT02637557|2951813|Superiority||LS Mean Difference|0.037||||0.7207|2-Sided|95.0|-0.167|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606893|NCT02637557|2951814|Superiority||LS Mean Difference|-0.333||||0.0289|2-Sided|95.0|-0.632|-0.035||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1607157|NCT02634073|2952053|Superiority or Other||Ratio|0.454|||||2-Sided|90.0|0.412|0.5|||||Cmax comparision||
1606894|NCT02637557|2951814|Superiority||LS Mean Difference|-0.125||||0.4064|2-Sided|95.0|-0.422|0.171||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606895|NCT02637557|2951814|Superiority||LS Mean Difference|0.042||||0.7804|2-Sided|95.0|-0.253|0.336||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606896|NCT02637557|2951814|Superiority||LS Mean Difference|-0.317||||0.0386|2-Sided|95.0|-0.616|-0.017||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606897|NCT02637557|2951814|Superiority||LS Mean Difference|-0.057||||0.7067|2-Sided|95.0|-0.355|0.241||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606898|NCT02637557|2951814|Superiority||LS Mean Difference|0.093||||0.5365|2-Sided|95.0|-0.203|0.388||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606899|NCT02637557|2951814|Superiority||LS Mean Difference|-0.291||||0.0447|2-Sided|95.0|-0.575|-0.007||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606900|NCT02637557|2951814|Superiority||LS Mean Difference|-0.078||||0.5859|2-Sided|95.0|-0.36|0.204||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606901|NCT02637557|2951814|Superiority||LS Mean Difference|0.078||||0.5831|2-Sided|95.0|-0.202|0.358||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606902|NCT02637557|2951814|Superiority||LS Mean Difference|-0.332||||0.0174|2-Sided|95.0|-0.605|-0.059||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606903|NCT02637557|2951814|Superiority||LS Mean Difference|-0.022||||0.8757|2-Sided|95.0|-0.293|0.25||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606904|NCT02637557|2951814|Superiority||LS Mean Difference|-0.025||||0.854|2-Sided|95.0|-0.294|0.244||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606905|NCT02637557|2951814|Superiority||LS Mean Difference|-0.324||||0.0203|2-Sided|95.0|-0.596|-0.051||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606906|NCT02637557|2951814|Superiority||LS Mean Difference|-0.073||||0.5966|2-Sided|95.0|-0.344|0.198||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606907|NCT02637557|2951814|Superiority||LS Mean Difference|-0.026||||0.848|2-Sided|95.0|-0.295|0.243||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606908|NCT02637557|2951814|Superiority||LS Mean Difference|-0.351||||0.0087|2-Sided|95.0|-0.612|-0.089||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606909|NCT02637557|2951814|Superiority||LS Mean Difference|-0.146||||0.2703|2-Sided|95.0|-0.405|0.114||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606910|NCT02637557|2951814|Superiority||LS Mean Difference|-0.004||||0.9736|2-Sided|95.0|-0.262|0.253||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606911|NCT02637557|2951814|Superiority||LS Mean Difference|-0.096||||0.4408|2-Sided|95.0|-0.342|0.149||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606912|NCT02637557|2951814|Superiority||LS Mean Difference|0.007||||0.9549|2-Sided|95.0|-0.237|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606913|NCT02637557|2951814|Superiority||LS Mean Difference|0.052||||0.6719|2-Sided|95.0|-0.19|0.294||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606914|NCT02637557|2951814|Superiority||LS Mean Difference|-0.021||||0.8415|2-Sided|95.0|-0.232|0.189||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606915|NCT02637557|2951814|Superiority||LS Mean Difference|0.189||||0.0761|2-Sided|95.0|-0.02|0.397||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606916|NCT02637557|2951814|Superiority||LS Mean Difference|0.093||||0.3788|2-Sided|95.0|-0.114|0.3||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606917|NCT02637557|2951815|Superiority||LS Mean Difference|-0.385||||0.0254|2-Sided|95.0|-0.722|-0.048||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1607158|NCT02634073|2952053|Superiority or Other||Ratio|0.479|||||2-Sided|90.0|0.434|0.527|||||Cmax comparision||
1606918|NCT02637557|2951815|Superiority||LS Mean Difference|-0.236||||0.1656|2-Sided|95.0|-0.57|0.098||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606919|NCT02637557|2951815|Superiority||LS Mean Difference|-0.044||||0.795|2-Sided|95.0|-0.378|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606920|NCT02637557|2951815|Superiority||LS Mean Difference|-0.386||||0.0273|2-Sided|95.0|-0.728|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606921|NCT02637557|2951815|Superiority||LS Mean Difference|-0.05||||0.7709|2-Sided|95.0|-0.389|0.289||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606922|NCT02637557|2951815|Superiority||LS Mean Difference|-0.051||||0.7673|2-Sided|95.0|-0.389|0.287||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606923|NCT02637557|2951815|Superiority||LS Mean Difference|-0.323||||0.0556|2-Sided|95.0|-0.653|0.008||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606924|NCT02637557|2951815|Superiority||LS Mean Difference|-0.024||||0.8838|2-Sided|95.0|-0.352|0.303||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606925|NCT02637557|2951815|Superiority||LS Mean Difference|0.086||||0.6068|2-Sided|95.0|-0.241|0.412||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606926|NCT02637557|2951815|Superiority||LS Mean Difference|-0.299||||0.0779|2-Sided|95.0|-0.633|0.034||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606927|NCT02637557|2951815|Superiority||LS Mean Difference|-0.02||||0.9059|2-Sided|95.0|-0.35|0.31||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606928|NCT02637557|2951815|Superiority||LS Mean Difference|0.048||||0.7736|2-Sided|95.0|-0.281|0.378||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606929|NCT02637557|2951815|Superiority||LS Mean Difference|-0.254||||0.1146|2-Sided|95.0|-0.57|0.062||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606930|NCT02637557|2951815|Superiority||LS Mean Difference|-0.059||||0.7109|2-Sided|95.0|-0.372|0.254||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606931|NCT02637557|2951815|Superiority||LS Mean Difference|-0.025||||0.8769|2-Sided|95.0|-0.337|0.288||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606932|NCT02637557|2951815|Superiority||LS Mean Difference|-0.311||||0.0471|2-Sided|95.0|-0.618|-0.004||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606933|NCT02637557|2951815|Superiority||LS Mean Difference|-0.125||||0.4213|2-Sided|95.0|-0.429|0.18||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606934|NCT02637557|2951815|Superiority||LS Mean Difference|-0.006||||0.968|2-Sided|95.0|-0.31|0.298||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606935|NCT02637557|2951815|Superiority||LS Mean Difference|-0.162||||0.2659|2-Sided|95.0|-0.449|0.124||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606936|NCT02637557|2951815|Superiority||LS Mean Difference|-0.013||||0.9283|2-Sided|95.0|-0.297|0.271||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606937|NCT02637557|2951815|Superiority||LS Mean Difference|0.051||||0.7209|2-Sided|95.0|-0.232|0.335||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606938|NCT02637557|2951815|Superiority||LS Mean Difference|-0.023||||0.856|2-Sided|95.0|-0.273|0.227||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606939|NCT02637557|2951815|Superiority||LS Mean Difference|0.148||||0.24|2-Sided|95.0|-0.1|0.396||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606940|NCT02637557|2951815|Superiority||LS Mean Difference|0.054||||0.6663|2-Sided|95.0|-0.193|0.301||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606941|NCT02637557|2951816|Superiority||LS Mean Difference|-0.452||||0.0098|2-Sided|95.0|-0.793|-0.11||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1607159|NCT02634073|2952053|Superiority or Other||Ratio|0.724|||||2-Sided|90.0|0.657|0.798|||||Cmax comparision||
1606942|NCT02637557|2951816|Superiority||LS Mean Difference|-0.298||||0.0842|2-Sided|95.0|-0.636|0.04||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606943|NCT02637557|2951816|Superiority||LS Mean Difference|-0.093||||0.5876|2-Sided|95.0|-0.431|0.245||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606944|NCT02637557|2951816|Superiority||LS Mean Difference|-0.366||||0.0384|2-Sided|95.0|-0.711|-0.02||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606945|NCT02637557|2951816|Superiority||LS Mean Difference|-0.114||||0.5121|2-Sided|95.0|-0.456|0.228||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606946|NCT02637557|2951816|Superiority||LS Mean Difference|-0.049||||0.777|2-Sided|95.0|-0.391|0.293||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606947|NCT02637557|2951816|Superiority||LS Mean Difference|-0.376||||0.0266|2-Sided|95.0|-0.708|-0.044||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606948|NCT02637557|2951816|Superiority||LS Mean Difference|-0.093||||0.5784|2-Sided|95.0|-0.421|0.236||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606949|NCT02637557|2951816|Superiority||LS Mean Difference|0.06||||0.7202|2-Sided|95.0|-0.269|0.388||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606950|NCT02637557|2951816|Superiority||LS Mean Difference|-0.422||||0.0138|2-Sided|95.0|-0.757|-0.087||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606951|NCT02637557|2951816|Superiority||LS Mean Difference|-0.097||||0.5649|2-Sided|95.0|-0.428|0.234||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606952|NCT02637557|2951816|Superiority||LS Mean Difference|-0.06||||0.7197|2-Sided|95.0|-0.392|0.271||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606953|NCT02637557|2951816|Superiority||LS Mean Difference|-0.298||||0.0651|2-Sided|95.0|-0.615|0.019||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606954|NCT02637557|2951816|Superiority||LS Mean Difference|-0.117||||0.4631|2-Sided|95.0|-0.43|0.196||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606955|NCT02637557|2951816|Superiority||LS Mean Difference|-0.047||||0.7689|2-Sided|95.0|-0.36|0.266||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606956|NCT02637557|2951816|Superiority||LS Mean Difference|-0.345||||0.0254|2-Sided|95.0|-0.647|-0.043||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606957|NCT02637557|2951816|Superiority||LS Mean Difference|-0.073||||0.632|2-Sided|95.0|-0.372|0.226||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606958|NCT02637557|2951816|Superiority||LS Mean Difference|-0.035||||0.8192|2-Sided|95.0|-0.333|0.264||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606959|NCT02637557|2951816|Superiority||LS Mean Difference|-0.118||||0.4192|2-Sided|95.0|-0.405|0.169||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606960|NCT02637557|2951816|Superiority||LS Mean Difference|0.028||||0.8466|2-Sided|95.0|-0.256|0.312||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606961|NCT02637557|2951816|Superiority||LS Mean Difference|0.079||||0.5824|2-Sided|95.0|-0.205|0.363||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606962|NCT02637557|2951816|Superiority||LS Mean Difference|-0.036||||0.7729|2-Sided|95.0|-0.284|0.212||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606963|NCT02637557|2951816|Superiority||LS Mean Difference|0.147||||0.2395|2-Sided|95.0|-0.098|0.392||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606964|NCT02637557|2951816|Superiority||LS Mean Difference|0.102||||0.4137|2-Sided|95.0|-0.143|0.347||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606965|NCT02637557|2951817|Superiority||LS Mean Difference|-0.403||||0.0264|2-Sided|95.0|-0.759|-0.048||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1607160|NCT02634073|2952053|Superiority or Other||Ratio|1.39|||||2-Sided|90.0|1.18|1.63|||||Ct comparision||
1606966|NCT02637557|2951817|Superiority||LS Mean Difference|-0.262||||0.1448|2-Sided|95.0|-0.614|0.091||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606967|NCT02637557|2951817|Superiority||LS Mean Difference|-0.078||||0.6649|2-Sided|95.0|-0.43|0.275||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 8|
1606968|NCT02637557|2951817|Superiority||LS Mean Difference|-0.3||||0.0954|2-Sided|95.0|-0.654|0.053||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606969|NCT02637557|2951817|Superiority||LS Mean Difference|-0.044||||0.8038|2-Sided|95.0|-0.394|0.306||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606970|NCT02637557|2951817|Superiority||LS Mean Difference|0.042||||0.8123|2-Sided|95.0|-0.308|0.392||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 7|
1606971|NCT02637557|2951817|Superiority||LS Mean Difference|-0.348||||0.0434|2-Sided|95.0|-0.686|-0.01||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606972|NCT02637557|2951817|Superiority||LS Mean Difference|-0.071||||0.6758|2-Sided|95.0|-0.406|0.263||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606973|NCT02637557|2951817|Superiority||LS Mean Difference|0.053||||0.7561|2-Sided|95.0|-0.282|0.387||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 6|
1606974|NCT02637557|2951817|Superiority||LS Mean Difference|-0.393||||0.022|2-Sided|95.0|-0.729|-0.057||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606975|NCT02637557|2951817|Superiority||LS Mean Difference|-0.055||||0.7453|2-Sided|95.0|-0.388|0.278||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606976|NCT02637557|2951817|Superiority||LS Mean Difference|-0.017||||0.9215|2-Sided|95.0|-0.349|0.316||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 5|
1606977|NCT02637557|2951817|Superiority||LS Mean Difference|-0.235||||0.139|2-Sided|95.0|-0.546|0.077||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606978|NCT02637557|2951817|Superiority||LS Mean Difference|0.004||||0.9772|2-Sided|95.0|-0.304|0.313||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606979|NCT02637557|2951817|Superiority||LS Mean Difference|-0.018||||0.9111|2-Sided|95.0|-0.326|0.291||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 4|
1606980|NCT02637557|2951817|Superiority||LS Mean Difference|-0.258||||0.0952|2-Sided|95.0|-0.562|0.045||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606981|NCT02637557|2951817|Superiority||LS Mean Difference|-0.062||||0.6873|2-Sided|95.0|-0.362|0.239||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606982|NCT02637557|2951817|Superiority||LS Mean Difference|-0.049||||0.7476|2-Sided|95.0|-0.35|0.251||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 3|
1606983|NCT02637557|2951817|Superiority||LS Mean Difference|-0.108||||0.4573|2-Sided|95.0|-0.393|0.177||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606984|NCT02637557|2951817|Superiority||LS Mean Difference|0.017||||0.9072|2-Sided|95.0|-0.266|0.299||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606985|NCT02637557|2951817|Superiority||LS Mean Difference|0.02||||0.8879|2-Sided|95.0|-0.262|0.303||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 2|
1606986|NCT02637557|2951817|Superiority||LS Mean Difference|-0.019||||0.8845|2-Sided|95.0|-0.27|0.233||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606987|NCT02637557|2951817|Superiority||LS Mean Difference|0.124||||0.3301|2-Sided|95.0|-0.126|0.373||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606988|NCT02637557|2951817|Superiority||LS Mean Difference|0.023||||0.856|2-Sided|95.0|-0.226|0.272||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA|||Week 1|
1606989|NCT02637557|2951818|Superiority||LS Mean Difference|0.461||||0.3275|2-Sided|95.0|-0.464|1.385||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1607161|NCT02634073|2952053|Superiority or Other||Ratio|1.46|||||2-Sided|90.0|1.25|1.71|||||Ct comparision||
1606990|NCT02637557|2951818|Superiority||LS Mean Difference|0.419||||0.3741|2-Sided|95.0|-0.507|1.345||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1606991|NCT02637557|2951818|Superiority||LS Mean Difference|0.019||||0.9675|2-Sided|95.0|-0.897|0.935||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1606992|NCT02637557|2951819|Superiority||LS Mean Difference|0.513||||0.3138|2-Sided|95.0|-0.488|1.513||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1606993|NCT02637557|2951819|Superiority||LS Mean Difference|0.252||||0.6177|2-Sided|95.0|-0.741|1.244||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1606994|NCT02637557|2951819|Superiority||LS Mean Difference|-0.298||||0.5504|2-Sided|95.0|-1.279|0.683||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1606995|NCT02637557|2951820|Superiority||Odds Ratio (OR)|1.97||||0.1463|2-Sided|95.0|0.79|4.91||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel||||
1606996|NCT02637557|2951820|Superiority||Odds Ratio (OR)|2.01||||0.128|2-Sided|95.0|0.81|4.98||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel||||
1606997|NCT02637557|2951820|Superiority||Odds Ratio (OR)|1.24||||0.6566|2-Sided|95.0|0.48|3.18||Odds ratio, 95% CI (Confidence Interval) for the Odds Ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel||||
1606998|NCT02637557|2951821|Superiority||Odds Ratio (OR)|1.56||||0.2237|2-Sided|95.0|0.76|3.2||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel||||
1606999|NCT02637557|2951821|Superiority||Odds Ratio (OR)|1.05||||0.8891|2-Sided|95.0|0.51|2.19||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel||||
1607000|NCT02637557|2951821|Superiority||Odds Ratio (OR)|0.56||||0.1489|2-Sided|95.0|0.25|1.23||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel||||
1607001|NCT02637557|2951822|Superiority||Odds Ratio (OR)|1.64||||0.1544|2-Sided|95.0|0.83|3.26||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel||||
1607002|NCT02637557|2951822|Superiority||Odds Ratio (OR)|1.38||||0.3518|2-Sided|95.0|0.7|2.71||Odds ratio, 95% CI for the odds ratio and p-value vs. placebo are obtained from the CMH tests controlling for esophagitis status.|Cochran-Mantel-Haenszel||||
1607003|NCT02637557|2951822|Superiority||Odds Ratio (OR)|0.91||||0.7903|2-Sided|95.0|0.47|1.77||Odds ratio, 95% confidence interval (CI) for the odds ratio and p-value vs. placebo are obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for esophagitis status.|Cochran-Mantel-Haenszel||||
1607004|NCT02637557|2951823|Superiority|||||||0.1374||||||Dose trend test performed using linear contrast statement.|trend test||||
1607005|NCT02637557|2951823|Superiority||LS Mean Difference|-0.257||||0.1157|2-Sided|95.0|-0.577|0.064||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1607006|NCT02637557|2951823|Superiority||LS Mean Difference|-0.047||||0.7699|2-Sided|95.0|-0.364|0.27||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1607007|NCT02637557|2951823|Superiority||LS Mean Difference|-0.052||||0.747|2-Sided|95.0|-0.369|0.265||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1607008|NCT02637557|2951824|Superiority|||||||0.013||||||Dose trend test performed using linear contrast statement.|trend test||||
1607009|NCT02637557|2951824|Superiority||LS Mean Difference|-0.417||||0.0237|2-Sided|95.0|-0.777|-0.056||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1607010|NCT02637557|2951824|Superiority||LS Mean Difference|-0.254||||0.1627|2-Sided|95.0|-0.611|0.103||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1607011|NCT02637557|2951824|Superiority||LS Mean Difference|-0.058||||0.7488|2-Sided|95.0|-0.415|0.299||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1607012|NCT02637557|2951825|Superiority|||||||0.1387||||||Dose trend test performed using linear contrast statement.|trend test||||
1607013|NCT02637557|2951825|Superiority||LS Mean Difference|-8.602||||0.1055|2-Sided|95.0|-19.03|1.826||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1607014|NCT02637557|2951825|Superiority||LS Mean Difference|-2.739||||0.602|2-Sided|95.0|-13.066|7.588||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1607015|NCT02637557|2951825|Superiority||LS Mean Difference|-3.711||||0.4795|2-Sided|95.0|-14.028|6.606||P-values are based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1607016|NCT02637557|2951826|Superiority|||||||0.0225||||||Dose trend test performed using linear contrast statement.|trend test||||
1607017|NCT02637557|2951826|Superiority||LS Mean Difference|-11.943||||0.04|2-Sided|95.0|-23.334|-0.551||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1607018|NCT02637557|2951826|Superiority||LS Mean Difference|-9.036||||0.116|2-Sided|95.0|-20.318|2.245||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1607019|NCT02637557|2951826|Superiority||LS Mean Difference|-2.952||||0.6065|2-Sided|95.0|-14.222|8.318||P-value based on a pairwise comparison versus placebo in an ANCOVA model with fixed effect terms for treatment group and esophagitis stratum and baseline value as covariate.|ANCOVA||||
1607020|NCT02637141|2951830|Superiority||LS Mean Difference|-1.64|Standard Error of the Mean|1.98||0.4088|2-Sided|95.0|-5.53|2.25|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.|||
1607021|NCT02637141|2951830|Superiority||LS Mean Difference|-2.76|Standard Error of the Mean|2.1||0.1908|2-Sided|95.0|-6.89|1.3|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.|||
1607022|NCT02637141|2951831|Superiority||LS Mean Difference|-2.62|Standard Error of the Mean|11.66||0.8221|2-Sided|95.0|-25.51|20.27|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.|||
1607023|NCT02637141|2951831|Superiority||LS Mean Difference|-13.44|Standard Error of the Mean|12.33||0.2761|2-Sided|95.0|-37.66|10.77|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.|||
1607024|NCT02637141|2951833|Superiority||Ratio of LS Means|1.03|Standard Error of the Mean|0.13||0.781|2-Sided|95.0|0.81|1.32|||Generalized Linear Mixed Model|Generalized linear mixed model with treatment group, site, sex, time (week), and time point-by-treatment group interaction as fixed effects.|||
1607025|NCT02637141|2951833|Superiority||Ratio of LS Means|0.83|Standard Error of the Mean|0.11||0.161|2-Sided|95.0|0.63|1.08|||Generalized Linear Mixed Model|Generalized linear mixed model with treatment group, site, sex, time (week), and time point-by-treatment group interaction as fixed effects.||Analysis of Total Weekly Bowel Movements at Week 12|
1607026|NCT02637141|2951834|Superiority||LS Mean Difference|2.86|Standard Error of the Mean|21.66||0.8955|2-Sided|95.0|-40.84|46.57|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP IgG|
1607027|NCT02637141|2951834|Superiority||LS Mean Difference|13.17|Standard Error of the Mean|26.77||0.6254|2-Sided|95.0|-40.86|67.2|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgG|
1607028|NCT02637141|2951834|Superiority||LS Mean Difference|-6.92|Standard Error of the Mean|15.46||0.6569|2-Sided|95.0|-38.11|24.28|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgA|
1607029|NCT02637141|2951834|Superiority||LS Mean Difference|17.8|Standard Error of the Mean|17.09||0.3034|2-Sided|95.0|-16.68|52.29|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.||Analysis of Change From Baseline in Anti-DGP-IgA|
1607030|NCT02637141|2951835|Superiority||LS Mean Difference|944.9|Standard Error of the Mean|1167.22||0.4228|2-Sided|95.0|-1410.65|3300.44|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.|||
1607031|NCT02637141|2951835|Superiority||LS Mean Difference|4402.25|Standard Error of the Mean|1717.4||0.014|2-Sided|95.0|936.39|7868.1|||Mixed-effect Model Repeat Measurement|The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects.|||
1607032|NCT02637141|2951837|Superiority||LS Mean Difference|-41.24|Standard Error of the Mean|18.85||0.0343|2-Sided|95.0|-79.28|-3.2|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.|||
1607033|NCT02637141|2951837|Superiority||LS Mean Difference|-14.32|Standard Error of the Mean|19.85||0.4746|2-Sided|95.0|-54.39|25.74|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.|||
1607034|NCT02637141|2951838|Superiority|P-values smaller than 0.05 were considered statistically significant.|LS Mean Difference|6.39|Standard Error of the Mean|6.67||0.3438|2-Sided|95.0|-7.07|19.85|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.|||
1607035|NCT02637141|2951838|Superiority|P-values smaller than 0.05 were considered statistically significant.|LS Mean Difference|-2.49|Standard Error of the Mean|7.1||0.7271|2-Sided|95.0|-16.82|11.83|||ANCOVA|The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect.|||
1607036|NCT02637037|2951850|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.02|||||2-Sided|90.0|0.94|1.1||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.|
1607037|NCT02637037|2951850|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of geometric means|1.0|||||2-Sided|90.0|0.95|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.|
1607162|NCT02634073|2952053|Superiority or Other||Ratio|1.33|||||2-Sided|90.0|1.13|1.56|||||Ct comparision||
1607038|NCT02637037|2951850|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||2-Sided|90.0|0.92|1.04||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.|
1607039|NCT02637037|2951850|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||2-Sided|90.0|0.96|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.|
1607040|NCT02637037|2951850|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.95|||||2-Sided|90.0|0.87|1.03||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.|
1607041|NCT02637037|2951850|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||2-Sided|90.0|0.89|1.05||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.|
1607042|NCT02637037|2951850|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||2-Sided|90.0|0.9|1.06||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.|
1607043|NCT02637037|2951850|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||2-Sided|90.0|0.93|1.03||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.|
1607044|NCT02637037|2951851|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||2-Sided|90.0|0.95|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.|
1607045|NCT02637037|2951851|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of geometric means|1.03|||||2-Sided|90.0|0.97|1.09||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.|
1607046|NCT02637037|2951851|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||2-Sided|90.0|0.95|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.|
1607047|NCT02637037|2951851|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.02|||||2-Sided|90.0|0.97|1.08||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.|
1607048|NCT02637037|2951851|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||2-Sided|90.0|0.95|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.|
1607049|NCT02637037|2951851|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||2-Sided|90.0|0.93|0.98||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.|
1607050|NCT02637037|2951851|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.99|||||2-Sided|90.0|0.97|1.02||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.|
1607051|NCT02637037|2951851|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||2-Sided|90.0|0.94|0.99||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.|
1607052|NCT02637037|2951852|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.03|||||2-Sided|90.0|0.96|1.1||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.|
1607163|NCT02634073|2952053|Superiority or Other||Ratio|1.09|||||2-Sided|90.0|1.0|1.18|||||C24 comparision||
1607164|NCT02634073|2952053|Superiority or Other||Ratio|1.12|||||2-Sided|90.0|1.03|1.21|||||C24 comparision||
1607053|NCT02637037|2951852|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.05|||||2-Sided|90.0|0.99|1.11||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.|
1607054|NCT02637037|2951852|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.0|||||2-Sided|90.0|0.93|1.07||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.|
1607055|NCT02637037|2951852|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|1.01|||||2-Sided|90.0|0.96|1.06||||||Metformin: Statistical Assessment of Bioequivalence for Metformin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.|
1607056|NCT02637037|2951852|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.98|||||2-Sided|90.0|0.95|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment G and H.|
1607057|NCT02637037|2951852|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.97|||||2-Sided|90.0|0.94|1.0||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 10/1000 mg for Treatment E and F.|
1607058|NCT02637037|2951852|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.99|||||2-Sided|90.0|0.96|1.01||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment C and D.|
1607059|NCT02637037|2951852|Non-Inferiority or Equivalence|If the 90% CIs for both dapagliflozin and metformin geometric mean ratio of AUC is entirely contained within an 80.00% to 125.00% interval, it will be concluded the 2 manufacturing sites are bioequivalent.|Ratios of Geometric means|0.96|||||2-Sided|90.0|0.93|0.99||||||Dapagliflozin: Statistical Assessment of Bioequivalence for Dapagliflozin following administration Dapagliflozin/Metformin XR 5/500 mg for Treatment A and B.|
1607060|NCT02635984|2951899|Superiority|||||||0.001|||||||Chi-squared||||
1607061|NCT02635984|2951900|Superiority|||||||0.13|||||||Chi-squared||||
1607062|NCT02635984|2951901|Superiority|||||||0.006|||||||Chi-squared||||
1607063|NCT02635984|2951902|Superiority|||||||0.002|||||||Chi-squared||||
1607064|NCT02635984|2951903|Superiority|||||||0.28|||||||Chi-squared||||
1607065|NCT02635984|2951904|Superiority|||||||0.11|||||||Chi-squared||||
1607066|NCT02635984|2951905|Superiority|||||||0.001|||||||Chi-squared||||
1607067|NCT02635984|2951906|Superiority|||||||0.003|||||||Chi-squared|||Based on an 80 % power and an alpha of 0.05, we estimated a need for 49 patients in each treatment arm. From a review of existing literature, the sample size was based on an estimated CR achieved in 65 % of patients on triplet therapy alone and a hypothesized clinically relevant increase of 25 % for the treatment group to 90 %.|
1607068|NCT02635646|2951911|Other||||||<|0.05|||||||t-test, 2 sided||||
1607069|NCT02635646|2951912|Other|||||||0.516|||||||t-test, 2 sided||||
1607070|NCT02635646|2951913|Other||||||<|0.05|||||||t-test, 2 sided||||
1607071|NCT02635646|2951914|Other|||||||0.624|||||||t-test, 2 sided||||
1607072|NCT02635646|2951915|Other|T test for mean comparisons between independent groups||||||0.844||||||Significant p value less than 0.05|t-test, 2 sided||||
1607073|NCT02635542|2951916|Superiority|||||||0.02|||||||t-test, 2 sided||||
1607074|NCT02635542|2951917|Superiority|||||||1|||||||Chi-squared||||
1607075|NCT02634983|2951936|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.66|Standard Error of the Mean|0.36||0.0821|2-Sided|90.0|0.04|1.27|||t-test, 2 sided|||Diffusion Capacity of Lung for CO|
1607076|NCT02634983|2951937|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.36||0.982|2-Sided|90.0|-0.62|0.6|||t-test, 2 sided|||Lung Clearance Index|
1607077|NCT02634983|2951938|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|4.98|Standard Error of the Mean|0.83|<|0.0001|2-Sided|90.0|3.56|6.39|||t-test, 2 sided|||FEV1/FVC Day 8 (2 hrs post-dose)|
1607078|NCT02634983|2951938|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|4.6|Standard Error of the Mean|0.85|<|0.0001|2-Sided|90.0|3.16|6.03|||t-test, 2 sided|||FEV1/FVC Day 8 (1 hrs post-dose)|
1607079|NCT02634983|2951938|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|3.74|Standard Error of the Mean|0.75|<|0.0001|2-Sided|90.0|2.45|5.02|||t-test, 2 sided|||FEV1/FVC Day 8 (0.25 hrs post-dose)|
1607080|NCT02634983|2951938|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|3.8|Standard Error of the Mean|0.76|<|0.0001|2-Sided|90.0|2.51|5.09|||t-test, 2 sided|||FEV1/FVC Day 8 (-0.25 hrs post-dose)|
1607081|NCT02634983|2951938|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.82|Standard Error of the Mean|0.83|<|0.0017|2-Sided|90.0|1.41|4.23|||t-test, 2 sided|||FEV1/FVC Day 8 (-0.75 hrs post-dose)|
1607082|NCT02634983|2951938|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.32|Standard Error of the Mean|0.66|<|0.0013|2-Sided|90.0|1.2|3.44|||t-test, 2 sided|||FEV1/FVC Day 1 (2 hrs post-dose)|
1607083|NCT02634983|2951938|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.06|Standard Error of the Mean|0.75|<|0.0106|2-Sided|90.0|0.78|3.33|||t-test, 2 sided|||FEV1/FVC Day 1 (1 hrs post-dose)|
1607084|NCT02634983|2951938|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|2.17|Standard Error of the Mean|0.56|<|0.0006|2-Sided|90.0|1.21|3.12|||t-test, 2 sided|||FEV1/FVC Day 1 (0.25 hrs post-dose)|
1607085|NCT02634983|2951939|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.44|Standard Error of the Mean|0.06|<|0.0001|2-Sided|90.0|0.33|0.55|||t-test, 2 sided|||FVC Day 8 (2 hrs post-dose)|
1607086|NCT02634983|2951939|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.45|Standard Error of the Mean|0.06|<|0.0001|2-Sided|90.0|0.36|0.54|||t-test, 2 sided|||FVC Day 8 (1 hrs post-dose)|
1607087|NCT02634983|2951939|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.43|Standard Error of the Mean|0.06|<|0.0001|2-Sided|90.0|0.33|0.53|||t-test, 2 sided|||FVC Day 8 (0.25 hrs post-dose)|
1607088|NCT02634983|2951939|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.06|<|0.0001|2-Sided|90.0|0.19|0.37|||t-test, 2 sided|||FVC Day 8 (-0.25 hrs post-dose)|
1607089|NCT02634983|2951939|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.35|Standard Error of the Mean|0.06|<|0.001|2-Sided|90.0|0.25|0.45|||t-test, 2 sided|||FVC Day 8 (-0.75 hrs post-dose)|
1607090|NCT02634983|2951939|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.31|Standard Error of the Mean|0.07|<|0.0001|2-Sided|90.0|0.2|0.42|||t-test, 2 sided|||FVC Day 1 (2 hrs post-dose)|
1607091|NCT02634983|2951939|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.35|Standard Error of the Mean|0.06|<|0.0001|2-Sided|90.0|0.25|0.45|||t-test, 2 sided|||FVC Day 1 (1 hrs post-dose)|
1607092|NCT02634983|2951939|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.05|<|0.0001|2-Sided|90.0|0.15|0.33|||t-test, 2 sided|||FVC Day 1 (0.25 hrs post-dose)|
1607093|NCT02634983|2951940|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.04|<|0.0001|2-Sided|90.0|0.26|0.38|||t-test, 2 sided|||FEV1 Day 8 (2 hrs post-dose)|
1607165|NCT02634073|2952053|Superiority or Other||Ratio|0.993|||||2-Sided|90.0|0.916|1.08|||||C24 comparison||
1607242|NCT02631070|2952235|Superiority|||||||0.2382|||||||Cochran-Mantel-Haenszel|||Week 1 -24|
1607094|NCT02634983|2951940|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.03|<|0.0001|2-Sided|90.0|0.26|0.37|||t-test, 2 sided|||FEV1 Day 8 (1 hrs post-dose)|
1607095|NCT02634983|2951940|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.03|<|0.0001|2-Sided|90.0|0.23|0.33|||t-test, 2 sided|||FEV1 Day 8 (0.25 hrs post-dose)|
1607096|NCT02634983|2951940|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.03|<|0.0001|2-Sided|90.0|0.16|0.28|||t-test, 2 sided|||FEV1 Day 8 (-0.25 hrs post-dose)|
1607097|NCT02634983|2951940|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.03|<|0.0001|2-Sided|90.0|0.16|0.27|||t-test, 2 sided|||FEV1 Day 8 (-0.75 hrs post-dose)|
1607098|NCT02634983|2951940|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.03|<|0.0001|2-Sided|90.0|0.13|0.24|||t-test, 2 sided|||FEV1 Day 1 (2 hrs post-dose)|
1607099|NCT02634983|2951940|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.03|<|0.0001|2-Sided|90.0|0.15|0.25|||t-test, 2 sided|||FEV1 Day 1 (1 hrs post-dose)|
1607100|NCT02634983|2951940|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment, time and treatment*Day*time interaction term as fixed factors and patient factor as random factor. Day*time was repeated within each patient*period interaction and subject average baseline and period adjusted baseline were included as covariates.|Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.02|<|0.0001|2-Sided|90.0|0.11|0.18|||t-test, 2 sided|||FEV1 Day 1 (0.25 hrs post-dose)|
1607101|NCT02634983|2951941|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.87|Standard Error of the Mean|0.94||0.3624|2-Sided|90.0|-0.73|2.48|||t-test, 2 sided|||Lung, Right Upper Lobe Perfusion|
1607102|NCT02634983|2951941|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.51|Standard Error of the Mean|1.7||0.3837|2-Sided|90.0|-1.39|4.4|||t-test, 2 sided|||Lung, Right Middle Lobe Perfusion|
1607103|NCT02634983|2951941|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.01|Standard Error of the Mean|1.08||0.9913|2-Sided|90.0|-1.85|1.87|||t-test, 2 sided|||Lung, Right Lower Lobe Perfusion|
1607104|NCT02634983|2951941|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.57|Standard Error of the Mean|0.93||0.5465|2-Sided|90.0|-1.02|2.16|||t-test, 2 sided|||Lung, Right Perfusion|
1607105|NCT02634983|2951941|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.9|Standard Error of the Mean|1.03||0.076|2-Sided|90.0|0.15|3.65|||t-test, 2 sided|||Lung, Left Upper Lobe Perfusion|
1607106|NCT02634983|2951941|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.69|Standard Error of the Mean|1.02||0.5031|2-Sided|90.0|-1.05|2.43|||t-test, 2 sided|||Lung, Left Lower Lobe Perfusion|
1607107|NCT02634983|2951941|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|1.34|Standard Error of the Mean|0.95||0.1717|2-Sided|90.0|-0.29|2.97|||t-test, 2 sided|||Lung, Left Perfusion|
1607108|NCT02634983|2951941|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|0.93|Standard Error of the Mean|0.92||0.323|2-Sided|90.0|-0.64|2.5|||t-test, 2 sided|||Lung Perfusion|
1607109|NCT02634983|2951942|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|7.73|Standard Error of the Mean|2.78||0.0099|2-Sided|90.0|2.98|12.47|||t-test, 2 sided|||Lung, Right Upper Lobe Ventilation|
1607110|NCT02634983|2951942|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.61|Standard Error of the Mean|3.71||0.1421|2-Sided|90.0|-0.71|11.94|||t-test, 2 sided|||Lung, Right Middle Lobe Ventilation|
1607111|NCT02634983|2951942|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|3.27|Standard Error of the Mean|2.29||0.165|2-Sided|90.0|-0.63|7.17|||t-test, 2 sided|||Lung, Right Lower Lobe Ventilation|
1607112|NCT02634983|2951942|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.39|Standard Error of the Mean|2.33||0.0286|2-Sided|90.0|1.42|9.35|||t-test, 2 sided|||Lung, Right Ventilation|
1607113|NCT02634983|2951942|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.97|Standard Error of the Mean|2.41||0.0486|2-Sided|90.0|0.87|9.07|||t-test, 2 sided|||Lung, Left Upper Lobe Ventilation|
1607114|NCT02634983|2951942|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.96|Standard Error of the Mean|2.86||0.0946|2-Sided|90.0|0.08|9.84|||t-test, 2 sided|||Lung, Left Lower Lobe Ventilation|
1607115|NCT02634983|2951942|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|4.77|Standard Error of the Mean|2.15||0.035|2-Sided|90.0|1.11|8.44|||t-test, 2 sided|||Lung, Left Ventilation|
1607116|NCT02634983|2951943|Non-Inferiority|Parameters were analyzed using mixed effects model including sequence, period, treatment as fixed factors and patient as random factor.|Mean Difference (Final Values)|5.0|Standard Error of the Mean|2.11||0.0254|2-Sided|90.0|1.4|8.6|||t-test, 2 sided|||Global Ventilated Lung Volume|
1607117|NCT02634801|2951985|Superiority or Other (legacy)||Risk Ratio (RR)|1.29||||0.0137|2-Sided|95.0|1.06|1.56|||Fisher Exact||||
1607118|NCT02634801|2951985|Superiority or Other (legacy)||Risk Ratio (RR)|4.08|||<|0.0001|2-Sided|95.0|2.46|6.77|||Fisher Exact||||
1607119|NCT02634788|2952000|Other||LS Mean Difference|35.46|Standard Error of the Mean|14.02||0.012|2-Sided|95.0|7.86|63.05|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1607120|NCT02634788|2952000|Other||LS Mean Difference|36.18|Standard Error of the Mean|14.099||0.0108|2-Sided|95.0|8.43|63.93|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1607121|NCT02634788|2952000|Other||LS Mean Difference|81.93|Standard Error of the Mean|14.283|<|0.0001|2-Sided|95.0|53.82|110.04|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1607122|NCT02634580|2952002|Superiority||LS Mean Treatment Difference|7.64|Standard Error of the Mean|9.88||0.44|2-Sided|95.0|-12.15|27.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607123|NCT02634580|2952003|Superiority||LS Mean Treatment Difference|-0.67|Standard Error of the Mean|7.26||0.93|2-Sided|95.0|-15.22|13.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607124|NCT02634580|2952004|Superiority||LS Mean Treatment Difference|5.59|Standard Error of the Mean|3.2||0.086|2-Sided|95.0|-0.82|12.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607125|NCT02634580|2952005|Superiority||LS Mean Treatment Difference|7.96|Standard Error of the Mean|3.08||0.012|2-Sided|95.0|1.78|14.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607126|NCT02634580|2952006|Superiority||LS Mean Treatment Difference|11.79|Standard Error of the Mean|9.52||0.22|2-Sided|95.0|-7.29|30.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607127|NCT02634580|2952007|Superiority||LS Mean Treatment Difference|3.49|Standard Error of the Mean|7.31||0.63|2-Sided|95.0|-11.15|18.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607128|NCT02634580|2952008|Superiority||LS Mean Treatment Difference|-31.21|Standard Error of the Mean|6.17|<|0.0001|2-Sided|95.0|-43.57|-18.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607129|NCT02634580|2952009|Superiority||LS Mean Treatment Difference|-31.13|Standard Error of the Mean|5.34|<|0.0001|2-Sided|95.0|-41.83|-20.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607130|NCT02634580|2952010|Superiority||LS Mean Treatment Difference|-36.29|Standard Error of the Mean|3.54|<|0.0001|2-Sided|95.0|-43.39|-29.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607131|NCT02634580|2952011|Superiority||LS Mean Treatment Difference|-37.07|Standard Error of the Mean|3.28|<|0.0001|2-Sided|95.0|-43.65|-30.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607166|NCT02634073|2952054|Superiority or Other||Ratio|0.585|||||2-Sided|90.0|0.548|0.626|||||AUC (0-t) comparision||
1607132|NCT02634580|2952012|Superiority||LS Mean Treatment Difference|-27.05|Standard Error of the Mean|3.47|<|0.0001|2-Sided|95.0|-34.0|-20.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607133|NCT02634580|2952013|Superiority||LS Mean Treatment Difference|-28.61|Standard Error of the Mean|3.32|<|0.0001|2-Sided|95.0|-35.26|-21.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607134|NCT02634580|2952014|Superiority||LS Mean Treatment Difference|-36.6|Standard Error of the Mean|3.68|<|0.0001|2-Sided|95.0|-43.98|-29.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607135|NCT02634580|2952015|Superiority||LS Mean Treatment Difference|-35.67|Standard Error of the Mean|3.31|<|0.0001|2-Sided|95.0|-42.3|-29.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607136|NCT02634580|2952016|Superiority||LS Mean Treatment Difference|-33.44|Standard Error of the Mean|3.75|<|0.0001|2-Sided|95.0|-40.94|-25.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607137|NCT02634580|2952017|Superiority||LS Mean Treatment Difference|-33.53|Standard Error of the Mean|3.42|<|0.0001|2-Sided|95.0|-40.38|-26.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607138|NCT02634580|2952018|Superiority||LS Mean Treatment Difference|-25.83|Standard Error of the Mean|2.89|<|0.0001|2-Sided|95.0|-31.63|-20.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607139|NCT02634580|2952019|Superiority||LS Mean Treatment Difference|-25.44|Standard Error of the Mean|2.68|<|0.0001|2-Sided|95.0|-30.8|-20.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607140|NCT02634580|2952020|Superiority||Treatment Difference|52.63|||<|0.0001|2-Sided|95.0|30.36|67.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Ezetimibe||
1607141|NCT02634580|2952021|Superiority||Treatment Difference|56.41|||<|0.0001|2-Sided|95.0|34.1|70.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).|Evolocumab - Ezetimibe||
1607142|NCT02634580|2952022|Superiority||LS Mean Treatment Difference|-79.4|Standard Error of the Mean|8.7|<|0.0001|2-Sided|95.0|-96.7|-62.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607143|NCT02634580|2952023|Superiority||LS Mean Treatment Difference|-77.6|Standard Error of the Mean|8.1|<|0.0001|2-Sided|95.0|-93.9|-61.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607144|NCT02634580|2952024|Superiority||LS Mean Treatment Difference|-40.14|Standard Error of the Mean|4.26|<|0.0001|2-Sided|95.0|-48.68|-31.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607145|NCT02634580|2952025|Superiority||LS Mean Treatment Difference|-39.35|Standard Error of the Mean|3.93|<|0.0001|2-Sided|95.0|-47.23|-31.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.|Evolocumab - Ezetimibe||
1607146|NCT02634346|2952027|Superiority||Least square mean difference|-0.44|Standard Error of the Mean|0.118|<|0.001|2-Sided|95.0|-0.67|-0.2|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.|||
1607147|NCT02634346|2952027|Superiority||Least square mean difference|-0.38|Standard Error of the Mean|0.118|<|0.002|2-Sided|95.0|-0.61|-0.14|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.|||
1607148|NCT02634346|2952028|Superiority||Least square mean difference|-5.3|Standard Error of the Mean|1.84||0.004|2-Sided|95.0|-8.9|-1.7|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.|||
1607149|NCT02634346|2952028|Superiority||Least square mean difference|-6.4|Standard Error of the Mean|1.83|<|0.001|2-Sided|95.0|-10.0|-2.8|||Mixed Models Analysis|Mixed model for repeated measures is based on observed data without imputation of missing data.|||
1607150|NCT02634320|2952034|Other|Statistical test is to confirm the change from baseline is statistically different from 0.||||||0.078||||||Change from baseline at last on-treatment visit|t-test, 2 sided||||
1607172|NCT02634073|2952054|Superiority or Other||Ratio|0.637|||||2-Sided|90.0|0.594|0.682|||||AUC (0-inf) comparision||
1607173|NCT02634073|2952054|Superiority or Other||Ratio|0.677|||||2-Sided|90.0|0.635|0.721|||||AUC (0-inf) comparision||
1607174|NCT02634073|2952054|Superiority or Other||Ratio|0.855|||||2-Sided|90.0|0.799|0.914|||||AUC (0-inf) comparison||
1607175|NCT02633956|2952055|Other|Estimation|Least Square Mean Difference|215.05|Standard Error of the Mean|79.51|||2-Sided|95.0|55.84|374.26|||||||
1607176|NCT02633956|2952055|Other|Estimation|Least Square Mean Difference|114.8|Standard Error of the Mean|68.08|||2-Sided|95.0|-21.53|251.13|||||||
1607177|NCT02633956|2952055|Other|Estimation|Least Square Mean Difference|103.61|Standard Error of the Mean|69.51|||2-Sided|95.0|-35.58|242.81|||||||
1607178|NCT02633956|2952056|Other|Estimation|Least Square Mean Difference|0.51|Standard Error of the Mean|0.19|||2-Sided|95.0|0.14|0.89|||||||
1607179|NCT02633956|2952056|Other|Estimation|Least Square Mean Difference|0.09|Standard Error of the Mean|0.17|||2-Sided|95.0|-0.25|0.42|||||||
1607180|NCT02633956|2952056|Other|Estimation|Least Square Mean Difference|0.41|Standard Error of the Mean|0.17|||2-Sided|95.0|0.07|0.75|||||||
1607181|NCT02633956|2952057|Other|Estimation|Least Square Mean Difference|20.13|Standard Error of the Mean|6.39|||2-Sided|95.0|7.33|32.92|||||||
1607182|NCT02633956|2952057|Other|Estimation|Least Square Mean Difference|9.06|Standard Error of the Mean|5.61|||2-Sided|95.0|-2.18|20.3|||||||
1607183|NCT02633956|2952057|Other|Estimation|Least Square Mean Difference|13.79|Standard Error of the Mean|5.75|||2-Sided|95.0|2.28|25.3|||||||
1607184|NCT02633800|2952060|Other|Both Log-rank test and Cox regression analysis did not adjust stratification factors.|Hazard Ratio (HR)|0.9291||||0.8342|2-Sided|95.0|0.4856|1.7778||Unstratified Log-rank p-value|Log Rank|||Heregulin-high population - Patritumab vs Placebo|
1607185|NCT02633501|2952064|Superiority||Least Squares Mean|51.96|Standard Error of the Mean|10.68|<|0.0001|2-Sided|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method|
1607186|NCT02633501|2952064|Superiority||Least Squares Mean|29.23|Standard Error of the Mean|6.53|<|0.0001|2-Sided|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method|
1607187|NCT02633501|2952064|Superiority||Least Squares Mean|2.47|Standard Error of the Mean|5.4|<|0.3249|2-Sided|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method|
1607188|NCT02633501|2952064|Superiority||Least Squares Mean|-23.96|Standard Error of the Mean|4.88|<||2-Sided|||||||||Holm's Step-Down Method|
1607189|NCT02633501|2952064|Superiority||Least Squares Mean|38.37|Standard Error of the Mean|9.76|<|0.0002|2-Sided|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method|
1607190|NCT02633501|2952064|Superiority||Least Squares Mean|19.38|Standard Error of the Mean|3.94|<|0.0001|2-Sided|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method|
1607191|NCT02633501|2952064|Superiority||Least Squares Mean|1.91|Standard Error of the Mean|4.56|<|0.3384|2-Sided|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method|
1607192|NCT02633501|2952064|Superiority||Least Squares Mean|-14.14|Standard Error of the Mean|4.55|<||2-Sided|||||||||Holm's Step-Down Method|
1607193|NCT02633501|2952064|Superiority||Least Squares Mean|14.45|Standard Error of the Mean|3.37|<|0.0001|2-Sided|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method|
1607194|NCT02633501|2952064|Superiority||Least Squares Mean|8.66|Standard Error of the Mean|2.55|<|0.0007|2-Sided|||||Superiority confirmed|Mixed Models Analysis|||Holm's Step-Down Method|
1607195|NCT02633501|2952064|Superiority||Least Squares Mean|2.18|Standard Error of the Mean|2.42|<|0.1858|2-Sided|||||Superiority not confirmed|Mixed Models Analysis|||Holm's Step-Down Method|
1607196|NCT02633501|2952064|Superiority||Least Squares Mean|-10.59|Standard Error of the Mean|2.0|<||2-Sided|||||||||Holm's Step-Down Method|
1607197|NCT02633488|2952065|Equivalence|equivalence defined as less that 2 SD in FMD between 2 treatments|||||>|0.05||||||FMD % change exceeded the threshold of our statistical significance test, i.e. the null hypothesis that there was no effect of metformin remained tenable.|t-test, 2 sided||||
1607198|NCT02633358|2952067|Superiority||||||<|0.05||||||P-value less then 0.05 is statistical significance.|t-test, 2 sided||||
1607199|NCT02633358|2952068|Superiority||||||<|0.05||||||P-value less than 0.05 is statistical significance.|t-test, 2 sided||||
1607200|NCT02633358|2952069|Superiority||||||<|0.05||||||P-value less than 0.05 is statistical significance.|t-test, 2 sided||||
1607201|NCT02633358|2952070|Superiority|Therapeutic hypothermia nee to have superiority in neurological outcome in the 90 days after enrollment.|Risk Ratio (RR)|0.8||||0.04|2-Sided|95.0|0.66|0.98||P value less than 0.05 means significant date|Chi-squared|Test method for proportional data||Therapeutic hypothermia group compare with control group|
1607202|NCT02633358|2952071|Superiority|Therapeutic hypothermia need to have superiority in the survival rate after 90 days|Risk Ratio (RR)|0.58|||<|0.001|2-Sided|95.0|0.41|0.82||P-value less than 0.05 means significant data|Chi-squared|Test method for proportional data||Therapeutic hypothermia group compare with control group|
1607203|NCT02633020|2952083|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.24||0.5561|2-Sided|95.0|-0.64|0.35|||Linear mixed effects repeated measures|Linear mixed effects repeated measures model with baseline value, treatment group, time point and a time point-by-treatment group as fixed effects.|||
1607204|NCT02633020|2952084|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.19||0.4832|2-Sided|95.0|-0.53|0.26|||Linear mixed effects repeated measures|Linear mixed effects repeated measures model with baseline value, treatment group, time point and time point-by-treatment group as fixed effects.|||
1607205|NCT02633020|2952086|Superiority||Ratio of LS Means|1.17|Standard Error of the Mean|0.24||0.4469|2-Sided|95.0|0.77|1.8|||Generalized Linear Mixed Model|Generalized linear mixed model with subject as a random effect and treatment group, time (week) and their interaction as fixed effects.|||
1607206|NCT02633020|2952087|Superiority||LS Mean Difference|-12.73|Standard Error of the Mean|31.34||0.6885|2-Sided|95.0|-77.57|52.12|||ANCOVA|ANCOVA) model with baseline total IEL counts as a covariate and treatment group as a fixed effect.|||
1607207|NCT02633020|2952088|Superiority||Odds Ratio (OR)|1.09||||0.9204|2-Sided|95.0|0.2|6.01|||Regression, Logistic||||
1607401|NCT02628028|2952538|Superiority|||||||0.905|||||||Regression, Logistic||||
1607208|NCT02633020|2952089|Superiority||LS Mean Difference|10.67|Standard Error of the Mean|24.0||0.6607|2-Sided|95.0|-38.97|60.31|||ANCOVA|ANCOVA model with baseline VH:CD ratio as a covariate and treatment group as a fixed effect.|||
1607209|NCT02633020|2952090|Superiority||LS Mean Difference|-38.22|Standard Error of the Mean|27.48||0.1803|2-Sided|95.0|-95.73|19.29|||ANCOVA|ANCOVA model with baseline % aberrant IELs vs intestinal epithelial cells as a covariate and treatment group as a fixed effect.|||
1607210|NCT02633020|2952091|Superiority||LS Mean Difference|-4.85|Standard Error of the Mean|14.7||0.7451|2-Sided|90.0|-30.26|20.56|||ANCOVA|Analysis of covariance (ANCOVA) with baseline % aberrant IELs vs total IELs as a covariate and treatment group as a fixed effect.|||
1607211|NCT02632786|2952104|Superiority|||||||0.4142|||||||Cochran-Mantel-Haenszel||||
1607212|NCT02632786|2952105|Superiority||Slope|-71.97||||0.0729|2-Sided|95.0|-150.72|6.79|||Mixed Models Analysis||||
1607213|NCT02632786|2952106|Superiority||Mean Difference (Net)|-0.6||||0.757|2-Sided|95.0|-4.2|3.0|||Mixed Models Analysis||||
1607214|NCT02632786|2952107|Superiority||Risk Ratio (RR)|1.54||||0.3529|2-Sided|95.0|0.6|3.94|||Cochran-Mantel-Haenszel||||
1607215|NCT02632786|2952108|Superiority||Mean Difference (Net)|5.0||||0.8992|2-Sided|95.0|-11.5|23.0|||ANCOVA||||
1607216|NCT02632786|2952109|Superiority||Mean Difference (Net)|-0.78||||0.5563|2-Sided|95.0|-3.37|1.81|||Mixed Models Analysis||||
1607217|NCT02632786|2952110|Superiority||Risk Ratio (RR)|0.82||||0.319|2-Sided|95.0|0.55|1.21|||Cochran-Mantel-Haenszel||||
1607218|NCT02632526|2952120|Superiority or Other||Ratio|64.58|||||2-Sided|90.0|54.34|76.74||||||AUC(0-τ)|
1607219|NCT02632526|2952121|Superiority or Other||Ratio|28.13|||||2-Sided|90.0|20.98|37.73||||||Cmax|
1607220|NCT02632526|2952134|Superiority or Other||Slope|1.43|Standard Error of the Mean|0.104|||2-Sided|90.0|1.25|1.6||||||Day 10|
1607221|NCT02632526|2952134|Superiority or Other||Slope|1.48|Standard Error of the Mean|0.0839|||2-Sided|90.0|1.34|1.63||||||For Day 1|
1607222|NCT02632526|2952135|Superiority or Other||Slope|0.35|Standard Error of the Mean|0.176|||2-Sided|90.0|0.0315|0.669|||||||
1607223|NCT02632526|2952135|Superiority or Other||Slope|1.55|Standard Error of the Mean|0.0692|||2-Sided|90.0|1.43|1.66|||||||
1607224|NCT02632526|2952136|Superiority or Other||Slope|1.23|Standard Error of the Mean|0.0851|||2-Sided|90.0|1.08|1.38||||||Day 10|
1607225|NCT02632526|2952138|Superiority or Other||Slope|1.22|Standard Error of the Mean|0.0813|||2-Sided|90.0|1.08|1.36||||||Day 1|
1607226|NCT02632526|2952139|Superiority or Other||Slope|0.322|Standard Error of the Mean|0.182|||2-Sided|90.0|-0.0124|0.656|||||||
1607227|NCT02632526|2952139|Superiority or Other||Slope|1.24|Standard Error of the Mean|0.0433|||2-Sided|90.0|1.17|1.31|||||||
1607228|NCT02631551|2952217|Superiority|||||||0.0043|||||||Mixed Models Analysis|||Mometasone furoate NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.|
1607229|NCT02631551|2952217|Superiority|||||||0.0755|||||||Mixed Models Analysis|||Olopatadine HCl NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level.|
1607230|NCT02631551|2952217|Superiority|||||||0.0587|||||||Mixed Models Analysis|||GSP 301 NS vs Mometasone furoate NS comparison for rTNSS was tested at 0.05 significance level.|
1607231|NCT02631551|2952217|Superiority|||||||0.0029|||||||Mixed Models Analysis|||GSP 301 NS vs Olopatadine HCl NS comparison for rTNSS was tested at 0.05 significance level.|
1607232|NCT02631551|2952217|Superiority||||||<|0.0001|||||||Mixed Models Analysis|||GSP 301 NS vs GSP 301 placebo NS comparison for rTNSS was tested at 0.05 significance level.|
1607233|NCT02631070|2952227|Superiority||Hazard Ratio (HR)|0.754||||0.3555|2-Sided|95.0|0.413|1.375|||Log Rank|Stratified based on average RBC transfusion burden: ≥ 6 RBC units versus < 6 RBC units/8 weeks and IPSS-R score (very low or low versus intermediate)|HR is from the Cox proportional hazards model with RBC transfusion ≥ 6 RBC units versus < 6 RBC units/8 weeks and IPSS-R score (very low or low versus intermediate) as covariates.||
1607234|NCT02631070|2952228|Superiority||Hazard Ratio (HR)|0.75||||0.7526|2-Sided|95.0|0.125|4.513|||Log Rank|Stratified based on average RBC transfusion burden: ≥ 6 RBC units versus < 6 RBC units/8 weeks and IPSS-R score (very low or low versus intermediate)|HR is from the Cox proportional hazards model with RBC transfusion ≥ 6 RBC units versus < 6 RBC units/8 weeks and IPSS-R score (very low or low versus intermediate) as covariates.||
1607235|NCT02631070|2952232|Superiority||LS Mean Difference|-24.9|Standard Error of the Mean|93.42||0.7903|2-Sided|95.0|-210.7|160.8|||ANCOVA|||Weeks 33 Through 48 Analysis of covariance was used to compare the treatment difference between groups, with the change in value as the dependent variable, treatment group (2 levels) as a factor, and baseline serum ferritin value as covariates, stratified by average baseline RBC transfusion requirement (≥ 6 units versus < 6 units of RBC per 8 weeks), and baseline IPSS-R (very low or low versus intermediate).|
1607236|NCT02631070|2952232|Superiority||LS Mean Difference|-41.0|Standard Error of the Mean|40.18||0.3087|2-Sided|95.0|-120.3|38.2|||ANCOVA|||Weeks 9 Through 24 Analysis of covariance was used to compare the treatment difference between groups, with the change in value as the dependent variable, treatment group (2 levels) as a factor, and baseline serum ferritin value as covariates, stratified by average baseline RBC transfusion requirement (≥ 6 units versus < 6 units of RBC per 8 weeks), and baseline IPSS-R (very low or low versus intermediate).|
1607237|NCT02631070|2952233|Superiority||LS Mean Difference|-319.5|Standard Error of the Mean|144.57||0.0294|2-Sided|95.0|-606.3|-32.7|||ANCOVA|||Weeks 33 Through 48 Analysis of covariance was used to compare the treatment difference between groups, with the change in value as the dependent variable, treatment group (2 levels) as a factor, and baseline serum ferritin value as covariates, stratified by average baseline RBC transfusion requirement (≥ 6 units versus < 6 units of RBC per 8 weeks), and baseline IPSS-R (very low or low versus intermediate).|
1607238|NCT02631070|2952233|Superiority||LS Mean Difference|-229.1|Standard Error of the Mean|74.43||0.0024|2-Sided|95.0|-375.8|-82.4|||ANCOVA|||Week 9 Through 24 Analysis of covariance was used to compare the treatment difference between groups, with the change in value as the dependent variable, treatment group (2 levels) as a factor, and baseline serum ferritin value as covariates, stratified by average baseline RBC transfusion requirement (≥ 6 units versus < 6 units of RBC per 8 weeks), and baseline IPSS-R (very low or low versus intermediate).|
1607239|NCT02631070|2952234|Superiority|||||||0.298|||||||Cochran-Mantel-Haenszel|||Week 1 - 48|
1607243|NCT02631070|2952241|Superiority||Hazard Ratio (HR)|0.784||||0.5121|2-Sided|95.0|0.362|1.699||Stratified based on average RBC transfusion burden: ≥ 6 RBC units versus < 6 RBC units/8 weeks and IPSS-R score (very low or low versus intermediate)|Log Rank||HR is from the Cox proportional hazards model with RBC transfusion ≥ 6 RBC units versus < 6 RBC units/8 weeks and IPSS-R score (very low or low versus intermediate) as covariates.|Week 1 Through 48|
1607244|NCT02631070|2952242|Superiority||Hazard Ratio (HR)|0.446||||0.0445|2-Sided|95.0|0.196|1.013|||Log Rank|Stratified based on average RBC transfusion burden: ≥ 6 RBC units versus < 6 RBC units/8 weeks and IPSS-R score (very low or low versus intermediate)|HR is from the Cox proportional hazards model with RBC transfusion ≥ 6 RBC units versus < 6 RBC units/8 weeks and IPSS-R score (very low or low versus intermediate) as covariates.|Week 1 Through 24|
1607245|NCT02631070|2952243|Superiority||||||<|0.0001|||||||Fisher Exact|||Week 1 Through Week 48|
1607246|NCT02631070|2952243|Superiority||||||<|0.0001|||||||Fisher Exact|||Week 1 Through Week 24|
1607247|NCT02631070|2952244|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 1 - 48|
1607248|NCT02631070|2952244|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 1 -24|
1607249|NCT02631070|2952246|Superiority||Common Risk Difference on Response Rate|29.55|||<|0.0001|2-Sided|95.0|18.73|40.36|||Cochran-Mantel-Haenszel|Stratified based on average RBC transfusion burden: ≥ 6 RBC units versus < 6 RBC units/8 weeks and IPSS-R score (very low or low versus intermediate)|||
1607250|NCT02631070|2952247|Superiority|Week 1 through Week 48; In order to preserve the overall alpha (α) level at 0.025 across the RBC-TI endpoints, formal statistical inference for the RBC-TI ≥ 12 weeks analysis (first tested for Week 1 to Week 48 and then Week 1 to Week 24) was to be made only if superiority of luspatercept was demonstrated for the primary efficacy endpoint (RBC-TI of ≥ 8 weeks), at the 1-sided 0.025 significance level.|Common Risk Difference on Response Rate|21.37||||0.0003|2-Sided|95.0|11.23|31.51|||Cochran-Mantel-Haenszel|Stratified based on average RBC transfusion burden: ≥ 6 RBC units versus < 6 RBC units/8 weeks and IPSS-R score (very low or low versus intermediate)|||
1607251|NCT02631070|2952247|Superiority||Common Risk Difference in Response Rate|20.0||||0.0002|2-Sided|95.0|10.92|29.08|||Cochran-Mantel-Haenszel|Stratified based on average RBC transfusion burden: ≥ 6 RBC units versus < 6 RBC units/8 weeks and IPSS-R score (very low or low versus intermediate)||Week 1 through Week 24; In order to preserve the overall alpha (α) level at 0.025 across the RBC-TI endpoints, formal statistical inference for the RBC-TI ≥ 12 weeks analysis (first tested for Week 1 to Week 48 and then Week 1 to Week 24) was to be made only if superiority of luspatercept was demonstrated for the primary efficacy endpoint (RBC-TI of ≥ 8 weeks), at the 1-sided 0.025 significance level.|
1607252|NCT02631070|2952248|Superiority||Common Risk Difference on Response Rate|24.56|||<|0.0001|2-Sided|95.0|14.48|34.64|||Cochran-Mantel-Haenszel|Stratified based on average RBC transfusion burden: ≥ 6 RBC units versus < 6 RBC units/8 weeks and IPSS-R score (very low or low versus intermediate)||In order to perform hypothesis testing on multiple endpoints while controlling the overall Type I error rate, a sequential testing approach was employed where the order of the endpoints to be tested was prespecified. The primary efficacy endpoint was tested first at the 1-sided 0.025 significance level.|
1607253|NCT02631057|2952249|Superiority or Other||Mean|-2.484|Standard Error of the Mean|0.629|<|0.001|2-Sided|95.0|-3.717|-1.251|||Abadie-Imbens|LoS Average Treatment Effect on the Treated (ATET) [Dabigatran group], dispersion analysed with Abadie-Imbens’s standard error.|The ATET of LoS from oral anticoagulant initiation to hospital discharge was calculated as [Dabigatran – Warfarin] in the matched cohort of matching ratio 1:3.||
1607254|NCT02630706|2952285|Other||Difference in % (Ert. 5 mg. - placebo)|-9.6|||<|0.001|2-Sided|95.0|-15.8|-5.7|||Miettinen & Nurminen method||||
1607255|NCT02630706|2952285|Other||Difference in % (Ert. 15 mg. - placebo)|-8.9|||<|0.001||95.0|-15.1|-4.2|||Miettinen & Nurminen method||||
1607256|NCT02630706|2952286|Other||Difference in % (Ert. 5 mg. - placebo)|-8.4|||<|0.001|2-Sided|95.0|-14.0|-4.4|||Miettinen & Nurminen method|Miettinen & Nurminen method stratified by country ('China' or 'other') for the overall population.|||
1607257|NCT02630706|2952286|Other||Difference in % (Ert. 15 mg. - placebo)|-9.0|||<|0.001||95.0|-14.5|-5.0|||Miettinen & Nurminen method|Miettinen & Nurminen method stratified by country ('China' or 'other') for the overall population.|||
1607258|NCT02630706|2952287|Superiority|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.29|||<|0.001|2-Sided|95.0|2.44|28.11||Nominal p-values were provided.|Logistic regression model||||
1607259|NCT02630706|2952287|Superiority|Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.34|||<|0.001|2-Sided|95.0|2.52|27.6||Nominal p-values were provided.|Logistic regression model||||
1607260|NCT02630706|2952288|Superiority|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|10.69|||<|0.001|2-Sided|95.0|2.95|38.71||Nominal p-values were provided.|Logistic regression model||||
1607261|NCT02630706|2952288|Superiority|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|8.9|||<|0.001|2-Sided|95.0|2.46|32.22||Nominal p-values were provided.|Logistic regression model||||
1607402|NCT02628028|2952539|Superiority|||||||0.951|||||||Regression, Logistic||||
1607403|NCT02628028|2952539|Superiority|||||||0.418|||||||Regression, Logistic||||
1607262|NCT02630706|2952289|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.0||||0.282|2-Sided|95.0|-2.83|0.83|||cLDA||||
1607263|NCT02630706|2952289|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-0.95||||0.315|2-Sided|95.0|-2.8|0.9|||cLDA||||
1607264|NCT02630706|2952290|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.42||||0.081|2-Sided|95.0|-3.01|0.17|||cLDA||||
1607265|NCT02630706|2952290|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.4||||0.086|2-Sided|95.0|-3.0|0.2|||cLDA||||
1607266|NCT02630706|2952291|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-4.08||||0.003|2-Sided|95.0|-6.78|-1.39|||cLDA||||
1607267|NCT02630706|2952291|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-2.64||||0.058|2-Sided|95.0|-5.36|0.09|||cLDA||||
1607268|NCT02630706|2952292|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-5.3|||<|0.001|2-Sided|95.0|-7.68|-2.92|||cLDA||||
1607269|NCT02630706|2952292|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-4.09|||<|0.001|2-Sided|95.0|-6.48|-1.69|||cLDA||||
1607270|NCT02630706|2952293|Superiority|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|3.47|||<|0.001|2-Sided|95.0|1.77|6.8|||Logistic regression model||||
1607271|NCT02630706|2952293|Superiority|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.49|||<|0.001|2-Sided|95.0|2.32|8.68|||Logistic regression model||||
1607272|NCT02630706|2952294|Superiority|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.59|||<|0.001|2-Sided|95.0|2.52|8.36|||Logistic regression model||||
1607273|NCT02630706|2952294|Superiority|Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment anti-hyperglycemic medication status at screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and baseline A1C (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.|Adjusted Odds Ratio relative to placebo|4.56|||<|0.001|2-Sided|95.0|2.49|8.35|||Logistic regression model||||
1607274|NCT02630706|2952295|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.79|||<|0.001|2-Sided|95.0|-2.36|-1.21|||cLDA||||
1607275|NCT02630706|2952295|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-2.05|||<|0.001|2-Sided|95.0|-2.63|-1.21|||cLDA||||
1607276|NCT02630706|2952296|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the LS Means vs. Placebo|-1.78|||<|0.001|2-Sided|95.0|-2.28|-1.28|||cLDA||||
1607277|NCT02630706|2952296|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-2.0|||<|0.001|2-Sided|95.0|-2.51|-1.5|||cLDA||||
1607278|NCT02630706|2952297|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-28.55|||<|0.001|2-Sided|95.0|-34.67|-22.43|||cLDA||||
1607404|NCT02628028|2952539|Superiority|||||||0.626|||||||Regression, Logistic||||
1607416|NCT02628028|2952543|Superiority|||||||0.473|||||||Regression, Logistic||||
1607279|NCT02630706|2952297|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-26.21|||<|0.001|2-Sided|95.0|-32.41|-20.01|||cLDA||||
1607280|NCT02630706|2952298|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-30.4|||<|0.001|2-Sided|95.0|-36.45|-24.35|||cLDA||||
1607281|NCT02630706|2952298|Superiority|cLDA model with fixed effects for treatment, time, anti-hyperglycemic medication status at Screening (metformin alone, metformin + another AHA), Country (China, other), baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in LS Means vs. Placebo|-27.78|||<|0.001|2-Sided|95.0|-33.85|-21.7|||cLDA||||
1607282|NCT02630706|2952301|Other||Difference in % vs. Placebo|-4.8|||||2-Sided|95.0|-16.5|6.9|||||||Miettinen-Nurminen method
1607283|NCT02630706|2952301|Other||Difference in % vs. Placebo|-8.9|||||2-Sided|95.0|-20.5|3.0|||||||Miettinen-Nurminen method
1607284|NCT02630706|2952302|Other||Difference in % vs. Placebo|-2.8|||||2-Sided|95.0|-13.3|7.7|||||||Miettinen-Nurminen method
1607285|NCT02630706|2952302|Other||Difference in % vs. Placebo|-6.0|||||2-Sided|95.0|-16.5|4.6|||||||Miettinen-Nurminen method
1607286|NCT02630706|2952303|Superiority|cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment.|Difference in the LS Means vs. Placebo|-0.76|||<|0.001|2-Sided|95.0|-0.95|-0.58|||cLDA||||
1607287|NCT02630706|2952303|Superiority||Difference in the LSM vs. placebo|-0.68|||<|0.001|2-Sided|95.0|-0.86|-0.5||cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), baseline eGFR (continuous) and the interaction of time by treatment.|cLDA||||
1607288|NCT02630706|2952304|Superiority|cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), country (China, other), baseline eGFR (continuous) and the interaction of time by treatment.|Difference in the LS Means vs. Placebo|-0.8|||<|0.001|2-Sided|95.0|-0.97|-0.63|||cLDA|||The primary hypothesis of the study was the mean change from baseline in HbA1c for 5 mg ertugliflozin is greater than that for placebo.|
1607289|NCT02630706|2952304|Superiority|Constrained longitudinal data analysis (cLDA)|Difference in the LSM vs. placebo|-0.69|||<|0.001|2-Sided|95.0|-0.85|-0.52||cLDA model with fixed effects for treatment, time, anti-AHA status at Screening (metformin alone, metformin + another AHA), country (China, other), baseline eGFR (continuous) and the interaction of time by treatment.|cLDA|Least squares means = LSM||The primary hypothesis of the study was the mean change from baseline in HbA1c for 15 mg ertugliflozin is greater than that for placebo.|
1607290|NCT02630693|2952305|Other|As stated in the protocol, the objective of this trial is to estimate the hazard ratio and the corresponding 90% confidence interval. Therefore, we do not conduct any statistical hypothesis test for overall survival.|Hazard Ratio (HR)|1.07|||||2-Sided|90.0|0.67|1.69|||||Hazard ratio for Palbociclib 100mg arm vs 125 mg arm||
1607291|NCT02630693|2952308|Other|As stated in the protocol, the primary objective of this trial is to estimate the hazard ratio and the corresponding 90% confidence interval. Therefore, we do not conduct any statistical hypothesis test for progression free survival.|Hazard Ratio (HR)|0.93|||||2-Sided|90.0|0.66|1.3|||||Hazard ratio of Palbociclib100mg arm vs 125 mg arm||
1607292|NCT02630459|2952320|Superiority|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.07||||0.004|2-Sided|95.0|-1.8|-0.35||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure|
1607293|NCT02630459|2952320|Superiority|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.07|||<|0.001|2-Sided|95.0|-2.66|-1.49||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure|
1607294|NCT02630459|2952320|Superiority|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.04|||<|0.001|2-Sided|95.0|-2.63|-1.45||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure|
1607295|NCT02630459|2952321|Superiority||Common Odds Ratio|3.21||||0.009|2-Sided|95.0|1.3|7.88||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.|
1607405|NCT02628028|2952540|Superiority||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.25||0.289|2-Sided|95.0|-0.77|0.23|||Mixed-effects Model for Repeated Measure||||
1607296|NCT02630459|2952321|Superiority||Common Odds Ratio|5.6|||<|0.001|2-Sided|95.0|2.6|12.06||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a CMH test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.|
1607297|NCT02630459|2952321|Superiority||Common Odds Ratio|4.73|||<|0.001|2-Sided|95.0|2.24|9.99||P-values for pairwise comparisons were nominal and obtained from the CMH test using data including placebo and corresponding erenumab dose group only.|Cochran-Mantel-Haenszel|||The common odds ratios and p-values were obtained from a Cochran-Mantel-Haenszel (CMH) test, stratified by stratification factor prior/current treatment with migraine prophylactic medication status.|
1607298|NCT02630459|2952322|Superiority|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.25||||0.004|2-Sided|95.0|-2.1|-0.41||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure|
1607299|NCT02630459|2952322|Superiority|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-2.31|||<|0.001|2-Sided|95.0|-3.0|-1.62||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure|
1607300|NCT02630459|2952322|Superiority|To maintain a family-wise type I error at 0.05, the pairwise comparisons were tested in a sequential testing procedure in the order of erenumab 140 mg QM vs placebo, erenumab 70 mg QM vs placebo and erenumab 28 mg QM vs placebo. The lower dose group was tested only when the higher dose group was considered statistically significant.|LS Mean Difference|-1.89|||<|0.001|2-Sided|95.0|-2.58|-1.2||P-values for pairwise comparisons were nominal and without multiplicity adjustment.|Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment with migraine prophylactic medication status), and baseline value as covariates and assumed a first-order autoregressive covariance structure|
1607301|NCT02629965|2952363|Superiority||Mean Difference (Final Values)|0.152|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.114|0.189|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607302|NCT02629965|2952364|Superiority||Mean Difference (Final Values)|0.083|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.059|0.108|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607303|NCT02629965|2952365|Superiority||Mean Difference (Final Values)|0.086|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.058|0.114|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607304|NCT02629965|2952366|Superiority||Mean Difference (Final Values)|0.082|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.056|0.108|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607305|NCT02629965|2952367|Superiority||Mean Difference (Final Values)|0.128|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.1|0.156|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607306|NCT02629965|2952368|Superiority||Mean Difference (Final Values)|0.133|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.103|0.162|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607307|NCT02629965|2952369|Superiority||Mean Difference (Final Values)|0.163|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.13|0.197|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607406|NCT02628028|2952540|Superiority||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.25||0.503|2-Sided|95.0|-0.32|0.65|||Mixed-effects Model for Repeated Measure||||
1607308|NCT02629965|2952370|Superiority||Mean Difference (Final Values)|0.105|Standard Error of the Mean|0.009|<|0.0001|2-Sided|95.0|0.088|0.123|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607309|NCT02629965|2952371|Superiority||Mean Difference (Final Values)|0.134|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.091|0.176|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607310|NCT02629965|2952372|Superiority||Mean Difference (Final Values)|2.42|Standard Error of the Mean|3.543||0.4955|2-Sided|95.0|-4.572|9.411|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607311|NCT02629965|2952373|Superiority||Mean Difference (Final Values)|2.257|Standard Error of the Mean|2.647||0.3949|2-Sided|95.0|-2.966|7.481|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607312|NCT02629965|2952374|Superiority||Mean Difference (Final Values)|0.939|Standard Error of the Mean|1.007||0.3524|2-Sided|95.0|-1.048|2.926|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607313|NCT02629965|2952375|Superiority||Mean Difference (Final Values)|-0.292|Standard Error of the Mean|0.469||0.5338|2-Sided|95.0|-1.217|0.633|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607314|NCT02629965|2952376|Superiority||Mean Difference (Final Values)|9.501|Standard Error of the Mean|83.704||0.9098|2-Sided|95.0|-155.692|174.694|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607315|NCT02629965|2952377|Superiority||Mean Difference (Final Values)|4.168|Standard Error of the Mean|5.26||0.4291|2-Sided|95.0|-6.211|14.548|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607316|NCT02629965|2952378|Superiority||Mean Difference (Final Values)|0.115|Standard Error of the Mean|0.019|<|0.001|2-Sided|95.0|0.077|0.153|||Mixed Models Analysis|Mixed Effect Model Repeated Measures includes treatment and period as fixed effects, study baseline as a covariate and patient as a random effect.|Adjusted mean of differences between treatments and standard error||Mixed effect repeated measurement was used to calculate adjusted mean values as well as treatment contrasts together with the 95% confidence intervals (CIs) and p-values.
1607317|NCT02629861|2952386|Superiority|||||||0.0021||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.|
1607318|NCT02629861|2952386|Superiority|||||||0.0023||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.|
1607319|NCT02629861|2952387|Superiority||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.|
1607320|NCT02629861|2952387|Superiority||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.|
1607321|NCT02629861|2952388|Superiority||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint|
1607322|NCT02629861|2952388|Superiority||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint|
1607323|NCT02629861|2952389|Superiority||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint|
1607407|NCT02628028|2952540|Superiority||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.25||0.863|2-Sided|95.0|-0.53|0.44|||Mixed-effects Model for Repeated Measure||||
1607324|NCT02629861|2952389|Superiority||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint|
1607325|NCT02629861|2952390|Superiority||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|
1607326|NCT02629861|2952390|Superiority||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|
1607327|NCT02629861|2952390|Superiority||||||<|0.0003||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|
1607328|NCT02629861|2952390|Superiority||||||<|0.0048||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|
1607329|NCT02629861|2952390|Superiority||||||<|0.001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|
1607330|NCT02629861|2952390|Superiority||||||<|0.0032||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|
1607331|NCT02629861|2952390|Superiority||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|
1607332|NCT02629861|2952390|Superiority||||||<|0.0001||||||0.05 level of significance|Cochran-Mantel-Haenszel|||Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|
1607333|NCT02629861|2952392|Superiority||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.|
1607334|NCT02629861|2952392|Superiority||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.|
1607335|NCT02629354|2952404|Superiority or Other||Percent Ratio Test/Ref|96.83|||||2-Sided|90.0|93.75|100.01|||||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability [%] was estimated by the ratios of the geometric means (100*test/reference [T/R]). Additionally, it's two-sided 90% CI was provided.|
1607336|NCT02629354|2952405|Superiority or Other||Percent Ratio Test/Ref|97.21|||||2-Sided|90.0|92.22|102.46|||||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability [%] was estimated by the ratios of the geometric means (100*test/reference [T/R]). Additionally, it's two-sided 90% CI was provided.|
1607337|NCT02629354|2952406|Superiority or Other||Percent Ratio Test/Ref|97.57|||||2-Sided|90.0|94.5|100.73|||||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability [%] was estimated by the ratios of the geometric means (100*test/reference [T/R]). Additionally, it's two-sided 90% CI was provided.|
1607338|NCT02629354|2952407|Superiority or Other||Percent Ratio Test/Ref|97.55|||||2-Sided|90.0|92.57|102.8|||||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability [%] was estimated by the ratios of the geometric means (100*test/reference [T/R]). Additionally, it's two-sided 90% CI was provided.|
1607339|NCT02629354|2952408|Superiority or Other||Percent Ratio Test/Ref|96.47|||||2-Sided|90.0|93.74|99.28|||||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability [%] was estimated by the ratios of the geometric means (100*test/reference [T/R]). Additionally, it's two-sided 90% CI was provided.|
1607340|NCT02629354|2952409|Superiority or Other||Percent Ratio Test/Ref|97.36|||||2-Sided|90.0|94.61|100.19|||||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability [%] was estimated by the ratios of the geometric means (100*test/reference [T/R]). Additionally, it's two-sided 90% CI was provided.|
1607341|NCT02629354|2952410|Superiority or Other||Percent Ratio Test/Ref|112.69|||||2-Sided|90.0|98.49|128.94|||||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability [%] was estimated by the ratios of the geometric means (100*test/reference [T/R]). Additionally, it's two-sided 90% CI was provided.|
1607342|NCT02629354|2952411|Superiority or Other||Percent Ratio Test/Ref|110.16|||||2-Sided|90.0|96.32|125.97|||||ANOVA with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability [%] was estimated by the ratios of the geometric means (100*test/reference [T/R]). Additionally, it's two-sided 90% CI was provided.|
1607343|NCT02629354|2952412|Superiority or Other||Percent Ratio Test/Ref|113.77|||||2-Sided|90.0|98.99|130.75|||||Analysis of variance (ANOVA) with fixed effects for sequence, subject nested within sequence, period and product after logarithmic transformation of the data.|Relative bioavailability [%] was estimated by the ratios of the geometric means (100*test/reference [T/R]). Additionally, it's two-sided 90% confidence interval (CI) was provided.|
1607344|NCT02629159|2952413|Superiority||Response Rate Difference|11.4|||<|0.001|2-Sided|95.0|6.5|16.4||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab||
1607345|NCT02629159|2952413|Superiority||Response Rate Difference|20.0|||<|0.001|2-Sided|95.0|16.3|23.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo||
1607408|NCT02628028|2952541|Superiority|||||||0.863|||||||Regression, Logistic||||
1607409|NCT02628028|2952541|Superiority|||||||0.028|||||||Regression, Logistic||||
1607410|NCT02628028|2952541|Superiority|||||||0.199|||||||Regression, Logistic||||
1607346|NCT02629159|2952414|Superiority||Response Rate Difference|-3.4||||0.187|2-Sided|95.0|-8.2|1.5||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.|Response Rate Difference = Upadacitinib - Adalimumab||
1607347|NCT02629159|2952414|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|7.5|||<|0.001|2-Sided|95.0|3.0|12.1||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for EU/EMA only.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo||
1607348|NCT02629159|2952415|Superiority||LS Mean Difference|-16.3|||<|0.001|2-Sided|95.0|-18.89|-13.71||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo||
1607349|NCT02629159|2952415|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-6.45|||<|0.001|2-Sided|95.0|-9.63|-3.27||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab||
1607350|NCT02629159|2952416|Superiority||LS Mean Difference|1.51||||0.017|2-Sided|95.0|0.27|2.76||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab||
1607351|NCT02629159|2952416|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|4.15|||<|0.001|2-Sided|95.0|3.13|5.16||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate|Treatment Difference = Upadacitinib - Placebo||
1607352|NCT02629159|2952417|Superiority||LS Mean Difference|-9.92||||0.164|2-Sided|95.0|-23.89|4.05||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab||
1607353|NCT02629159|2952417|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-44.04|||<|0.001|2-Sided|95.0|-55.39|-32.69||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo||
1607354|NCT02629159|2952418|Superiority||Response Rate Difference|10.4||||0.001|2-Sided|95.0|4.2|16.7||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab||
1607355|NCT02629159|2952418|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|24.1|||<|0.001|2-Sided|95.0|19.4|28.8||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.|Response Rate Difference = Upadacitinib - Placebo||
1607356|NCT02629159|2952419|Superiority||||||<|0.001||||||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|||
1607357|NCT02629159|2952419|Non-Inferiority|A non-inferiority test of upadacitinib versus adalimumab was evaluated using the lower bound of the 95% confidence interval (CI) of the treatment difference against a non-inferiority margin of 10%. This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for EU/EMA only.|Response Rate Difference|16.3|||<||2-Sided|95.0|10.0|22.5|||||Response Rate Difference = Upadacitinib - Adalimumab||
1607358|NCT02629159|2952419|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|31.2|||<|0.001|2-Sided|95.0|26.5|35.8||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo||
1607411|NCT02628028|2952542|Superiority|||||||0.858|||||||Regression, Logistic||||
1607412|NCT02628028|2952542|Superiority|||||||0.124|||||||Regression, Logistic||||
1607413|NCT02628028|2952542|Superiority|||||||0.743|||||||Regression, Logistic||||
1607359|NCT02629159|2952420|Superiority||LS Mean Difference|1.62||||0.002|2-Sided|95.0|0.62|2.62||This comparison was not part of the pre-specified multiplicity testing sequence.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Adalimumab||
1607360|NCT02629159|2952420|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|4.33|||<|0.001|2-Sided|95.0|3.52|5.15||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|Mixed Effect Model Repeat Measurement|MMRM model with fixed effects of treatment, visit, and treatment-by-visit interaction, previous bDMARD use, and Baseline value as covariate.|Treatment Difference = Upadacitinib - Placebo||
1607361|NCT02629159|2952421|Superiority||Response Rate Difference|30.3|||<|0.001|2-Sided|95.0|25.6|35.0||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo||
1607362|NCT02629159|2952421|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|||||<|0.001||||||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use.|||
1607363|NCT02629159|2952421|Non-Inferiority|A non-inferiority test of upadacitinib versus adalimumab was evaluated using the lower bound of the 95% confidence interval (CI) of the treatment difference against a non-inferiority margin of 10%. This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|Response Rate Difference|16.1|||<||2-Sided|95.0|9.9|22.3|||||Response Rate Difference = Upadacitinib - Adalimumab||
1607364|NCT02629159|2952422|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.11||||0.004|2-Sided|95.0|-0.184|-0.036||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA only.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab||
1607365|NCT02629159|2952422|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.31|||<|0.001|2-Sided|95.0|-0.372|-0.253||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo||
1607366|NCT02629159|2952423|Superiority||LS Mean Difference|0.14||||0.448|2-Sided|95.0|-0.23|0.51||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab||
1607367|NCT02629159|2952423|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-0.67|||<|0.001|2-Sided|95.0|-0.97|-0.37||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo||
1607368|NCT02629159|2952424|Superiority||LS Mean Difference|-0.47|||<|0.001|2-Sided|95.0|-0.638|-0.295||This comparison was not part of the pre-specified multiplicity testing sequence.|ANCOVA|ANCOVA model with treatment, prior biological DMARD use and Baseline value as covariates.|Treatment Difference = Upadacitinib - Adalimumab||
1607369|NCT02629159|2952424|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|LS Mean Difference|-1.33|||<|0.001|2-Sided|95.0|-1.469|-1.194||This comparison was a ranked key secondary endpoint in the pre-specified multiplicity testing sequence for US/FDA and EU/EMA.|ANCOVA|Analysis of covariance (ANCOVA) model with treatment, prior biological DMARD use, and Baseline value as covariates.|Treatment Difference = Upadacitinib - Placebo||
1607370|NCT02629159|2952425|Superiority||Response Rate Difference|10.7|||<|0.001|2-Sided|95.0|5.3|16.1||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab||
1607371|NCT02629159|2952425|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|22.6|||<|0.001|2-Sided|95.0|18.6|26.5||This comparison was the primary analysis for EU/EMA regulatory purposes, and a ranked key secondary endpoint for US/FDA regulatory purposes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo||
1607372|NCT02629159|2952426|Superiority||Response Rate Difference|7.5||||0.018|2-Sided|95.0|1.2|13.8||This comparison was not part of the pre-specified multiplicity testing sequence.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Adalimumab||
1607373|NCT02629159|2952426|Superiority|In order to preserve Type I error, a step-down approach was used to test the primary and ranked key secondary endpoints in a pre-specified order where statistical significance at the 0.05 level could be claimed for a lower ranked endpoint only if the previous endpoint in the sequence met the requirements of significance.|Response Rate Difference|34.1|||<|0.001|2-Sided|95.0|29.0|39.2||This comparison was the primary analysis for US/FDA regulatory purposes, and a ranked key secondary endpoint for EU/EMA regulatory purposes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for the stratification factor of prior biological DMARD use|Response Rate Difference = Upadacitinib - Placebo||
1607374|NCT02629133|2952427|Superiority||Mean Difference (Final Values)|-1.43||||0.119|2-Sided|95.0|-3.24|0.38||We conducted HLM predicting SBC Total scores at 3 and 6 months post-shelter release from treatment condition, using baseline SBC score as a covariate.|Mixed Models Analysis||Higher is better (reflecting more safety behaviors used).||
1607375|NCT02629133|2952428|Superiority||Mean Difference (Final Values)|1.19||||0.192|2-Sided|95.0|-0.61|2.98||We used HLM to predict Cyber-Stalking Scores across 3 and 6 month post shelter follow-up points from treatment condition, using baseline score as a covariate.|Mixed Models Analysis||Higher scores represent more cyber-stalking over follow-up.||
1607376|NCT02629133|2952429|Superiority||Mean Difference (Final Values)|4.5||||0.325|2-Sided|95.0|-4.5|13.5||We used hierarchical linear modeling (HLM) to predict 3-mo and 6-mo post-shelter scores from treatment condition, using baseline score as a covariate.|Mixed Models Analysis||||
1607377|NCT02629133|2952430|Superiority|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||Distributions were badly skewed, and the sample was too small for ZINB or other analyses. Therefore, we analyzed differences between conditions in changes in services/day over time (i.e., from baseline to 6 month post-shelter follow-up) using the Mann-Whitney U.|
1607378|NCT02629133|2952430|Superiority|||||||0.026|||||||Wilcoxon (Mann-Whitney)||||
1607379|NCT02629133|2952431|Superiority|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Differences between conditions in the change in % heavy drinking/using days from baseline to 6 months|
1607380|NCT02629133|2952431|Superiority|||||||0.56|||||||Wilcoxon (Mann-Whitney)||||
1607381|NCT02628938|2952441|Superiority or Other|||||||0.02|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Chlorohexidine gluconate mouth wash|
1607382|NCT02628938|2952441|Superiority or Other|||||||0.001|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak sticks|
1607383|NCT02628938|2952441|Superiority or Other|||||||0.008|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Self-assessment scores after 7 days of using Miswak extract mouth wash|
1607384|NCT02628938|2952442|Superiority or Other|||||||0.82|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Chlorohexidine gluconate mouth wash|
1607385|NCT02628938|2952442|Superiority or Other|||||||0.341|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Chlorohexidine gluconate mouth wash|
1607386|NCT02628938|2952442|Superiority or Other|||||||0.829|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of of using Miswak sticks|
1607387|NCT02628938|2952442|Superiority or Other|||||||0.19|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak sticks|
1607388|NCT02628938|2952442|Superiority or Other|||||||0.244|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 7 days of using Miswak extract mouth wash|
1607389|NCT02628938|2952442|Superiority or Other|||||||0.496|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Volatile sulfur compound scores after 15 minutes of the first use of Miswak extract mouth wash|
1607390|NCT02628938|2952443|Superiority or Other|||||||0.001|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Chlorohexidine gluconate mouth wash|
1607391|NCT02628938|2952443|Superiority or Other|||||||0|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Chlorohexidine gluconate mouth wash|
1607392|NCT02628938|2952443|Superiority or Other|||||||0|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak sticks|
1607393|NCT02628938|2952443|Superiority or Other|||||||0.019|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak sticks|
1607394|NCT02628938|2952443|Superiority or Other|||||||0.007|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 7 days of using Miswak extract mouth wash|
1607395|NCT02628938|2952443|Superiority or Other|||||||0.299|||||||t-test, 2 sided|||Paired t-test was performed to examine the significance of change in Organoleptic scores after 15 minutes of the first use of Miswak extract mouth wash|
1607396|NCT02628093|2952531|Other|||||||1||||||P value threshold <0.05|Fisher Exact||||
1607397|NCT02628093|2952535|Other|||||||0.007||||||P value threshold <0.05|Wilcoxon (Mann-Whitney)|||compared between groups by the Wilcoxon rank-sum test|
1607398|NCT02628093|2952536|Other|Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required.||||||0.214||||||P value threshold <0.05|Wilcoxon (Mann-Whitney)|||Because this was a pilot (exploratory) randomized study, no formal sample size calculation was required. Demographic, preoperative, and postoperative variables and the primary outcome were compared between groups (THUNDERBEAT and LigaSure) by the Wilcoxon rank-sum test for continuous variables and the chi-square test/Fisher’s exact test for categorical variables, as appropriate. All p-values are two-sided with statistical significance evaluated at the 0.05 alpha level.|
1607399|NCT02628028|2952538|Superiority|||||||0.547|||||||Regression, Logistic||||
1607400|NCT02628028|2952538|Superiority|||||||0.069|||||||Regression, Logistic||||
1607417|NCT02627963|2952548|Superiority||Hazard Ratio (HR)|0.73||||0.016|2-Sided|95.0|0.56|0.94||A one-sided, log-rank test stratified for IMDC risk category and prior therapy (two VEGFR TKIs vs. a checkpoint inhibitor plus a VEGFR TKI vs. a VEGFR TKI plus any other systemic agent) at a significance level of α = 0.025 will be used.|Log Rank||||
1607418|NCT02627924|2952555|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 24|
1607419|NCT02627924|2952555|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 12|
1607420|NCT02627924|2952555|Other||||||<|0.0015|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 24|
1607421|NCT02627924|2952555|Other||||||<|0.0098|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 12|
1607422|NCT02627924|2952556|Other||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 24 weeks|
1607423|NCT02627924|2952556|Other||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 12 weeks|
1607424|NCT02627924|2952557|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 24|
1607425|NCT02627924|2952557|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 12|
1607426|NCT02627924|2952557|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 24|
1607427|NCT02627924|2952557|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 12|
1607428|NCT02627924|2952559|Other||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.|||
1607429|NCT02627924|2952560|Other||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.|||
1607430|NCT02627118|2952574|Other|||||||0.05|||||||t-test, 1 sided||||
1607431|NCT02627001|2952575|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Ranks||||
1607432|NCT02626819|2952577|Superiority||||||<|0.05|||||||Fisher Exact||||
1607433|NCT02626819|2952578|Superiority||||||<|0.05|||||||Fisher Exact||||
1607434|NCT02626819|2952579|Superiority||||||<|0.05|||||||Fisher Exact||||
1607435|NCT02626819|2952580|Superiority||||||<|0.05|||||||Fisher Exact||||
1607436|NCT02626819|2952581|Superiority||||||<|0.05|||||||Fisher Exact||||
1607437|NCT02626819|2952582|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data|||
1607438|NCT02626819|2952583|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data.|||
1607439|NCT02626819|2952584|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data|||
1607440|NCT02625974|2952612|Other||||||||||||||||||"Historical Benznidazole 1998, publication from Sosa Estani et al. (1998), 4-year follow-up data.~Number Analyzed: 53 Number Cured: 4 Cure rate: 7.5%~Historical Benznidazole 1996, publication from de Andrade et al. (1996), 3-year follow-up data.~Number Analyzed: 64 Number Cured: 4 Cure rate: 6.25%"
1607441|NCT02625974|2952645|Other|A direct comparison|Difference in cure rate|14.0|||||2-Sided|95.0|3.7|24.2||||||"Historical Cure Rates for Placebo~Publication 1: De Andrade et al 1996. Age range (years): 7-12. Sero-conversion rate (95% CI) in placebo patients: 3/65 = 5% (1%, 13%)~Publication 2: Sosa et al 1998. Age range (years): 6-12. Sero-conversion rate (95% CI) in placebo patients: 2/44 = 5% (1%, 16%).~CI = confidence interval"|
1607442|NCT02625623|2952655|Superiority||Odds Ratio (OR)|0.709||||0.8764|||||||Cochran-Mantel-Haenszel|The treatment arms were compared by 1-sided CMH test. The stratification factor was region (Asia versus non Asia).|||
1607443|NCT02625623|2952657|Superiority||Hazard Ratio (HR)|1.73||||1|2-Sided|95.0|1.36|2.21|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).|||
1607444|NCT02625623|2952658|Superiority||Hazard Ratio (HR)|1.11||||0.8078|2-Sided|95.0|0.88|1.41|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank Test. The stratification factor was region (Asia versus non Asia).|||
1607445|NCT02625402|2952676|Equivalence|Knowledge scores within 10% points|Mean Difference (Final Values)|6.4|Standard Error of the Mean|7.6|<|0.05|2-Sided|95.0|-8.8|21.5|||t-test, 2 sided||||
1607446|NCT02625324|2952684|Superiority||Event Rate|0.023|||<|0.0001|1-Sided|97.5||0.081|||Exact binomial test|||"The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:~H0: p ≥ 16% vs. Ha: p <16%, where p denotes the true event rate of primary study endpoint in the target population."|
1607447|NCT02625298|2952686|Other||||||<|0.01|||||||Mixed Models Analysis||||
1607448|NCT02625259|2952688|Superiority or Other||Geometric mean ratio|0.08|||||2-Sided|90.0|0.03|0.18||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.|
1607449|NCT02625259|2952688|Superiority or Other||Geometric mean ratio|1.5|||||2-Sided|90.0|1.0|2.25||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet dosage form with food versus without food.|
1607450|NCT02625259|2952688|Superiority or Other||Geometric mean ratio|1.53|||||2-Sided|90.0|0.93|2.51||||||Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUC∞ of TAK-117 tablet versus capsule dosage form.|
1607451|NCT02625259|2952689|Superiority or Other||Geometric mean ratio|0.02|||||2-Sided|90.0|0.01|0.04||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.|
1607452|NCT02625259|2952689|Superiority or Other||Geometric mean ratio|1.76|||||2-Sided|90.0|1.11|2.78||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet dosage form with food versus without food.|
1607622|NCT02621060|2952996|Superiority or Other|||||||0.594|||||||Wilcoxon (Mann-Whitney)||||
1607453|NCT02625259|2952689|Superiority or Other||Geometric mean ratio|1.47|||||2-Sided|90.0|0.98|2.18||||||Analysis of variance was performed for calculating 90 % CIs for the ratios of log-transformed geometric mean AUClast of TAK-117 tablet versus capsule dosage form.|
1607454|NCT02625259|2952691|Superiority or Other||Geometric mean ratio|0.03|||||2-Sided|90.0|0.02|0.07||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with lansoprazole versus a single dose of TAK-117 alone.|
1607455|NCT02625259|2952691|Superiority or Other||Geometric mean ratio|1.2|||||2-Sided|90.0|0.86|1.67||||||Analysis of variance was performed for calculating 90% CIs for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet dosage form with food versus without food.|
1607456|NCT02625259|2952691|Superiority or Other||Geometric mean ratio|1.36|||||2-Sided|90.0|1.0|1.83||||||Analysis of variance was performed for calculating 90 percent (%) confidence intervals (CIs) for the ratios of log-transformed geometric mean Cmax of TAK-117 tablet versus capsule dosage form.|
1607457|NCT02625207|2952713|Superiority or Other||Adjusted Geometric Mean Ratio|99.62||||0.9713|2-Sided|90.0|83.07|119.45|||Mixed Models Analysis||||
1607458|NCT02625207|2952714|Superiority or Other||Adjusted Geometric Mean Ratio|71.82||||0.0104|2-Sided|90.0|58.37|88.39|||Mixed Models Analysis||||
1607459|NCT02625207|2952714|Superiority or Other||Adjusted Geometric Mean Ratio|71.84||||0.0104|2-Sided|90.0|58.38|88.4|||Mixed Models Analysis||||
1607460|NCT02625207|2952714|Superiority or Other||Adjusted Geometric Mean Ratio|75.74||||0.0331|2-Sided|90.0|61.26|93.64|||Mixed Models Analysis||||
1607461|NCT02625207|2952714|Superiority or Other||Adjusted Geometric Mean Ratio|105.43||||0.6771||90.0|85.28|130.35|||Mixed Models Analysis||||
1607462|NCT02625207|2952714|Superiority or Other||Adjusted Geometric Mean Ratio|94.83||||0.6761|2-Sided|90.0|76.7|117.24|||Mixed Models Analysis||||
1607463|NCT02625207|2952715|Superiority or Other||Adjusted Geometric Mean Ratio|68.32||||0.0505|2-Sided|90.0|49.81|93.71|||Mixed Models Analysis||||
1607464|NCT02625207|2952716|Superiority or Other||Adjusted Geometric Mean Ratio|72.37||||0.0135|2-Sided|90.0|58.6|89.36|||Mixed Models Analysis||||
1607465|NCT02625207|2952716|Superiority or Other||Adjusted Geometric Mean Ratio|70.16||||0.0071|2-Sided|90.0|56.81|86.63|||Mixed Models Analysis||||
1607466|NCT02625207|2952716|Superiority or Other||Adjusted Geometric Mean Ratio|61.23||||0.0004|2-Sided|90.0|49.35|75.97|||Mixed Models Analysis||||
1607467|NCT02625207|2952716|Superiority or Other||Adjusted Geometric Mean Ratio|87.28||||0.2947|2-Sided|90.0|70.34|108.28|||Mixed Models Analysis||||
1607468|NCT02625207|2952716|Superiority or Other||Adjusted Geometric Mean Ratio|118.19||||0.1997|2-Sided|90.0|95.26|146.63|||Mixed Models Analysis||||
1607469|NCT02625207|2952717|Superiority or Other||Adjusted Geometric Mean Ratio|82.42||||0.0507|2-Sided|90.0|70.2|96.77|||Mixed Models Analysis||||
1607470|NCT02625207|2952718|Superiority or Other||Adjusted Geometric Mean Ratio|73.89||||0.0037|2-Sided|90.0|62.61|87.2|||Mixed Models Analysis||||
1607471|NCT02625207|2952718|Superiority or Other||Adjusted Geometric Mean ratio|73.79||||0.0036|2-Sided|90.0|62.53|87.09|||Mixed Models Analysis||||
1607472|NCT02625207|2952718|Superiority or Other||Adjusted Geometric Mean Ratio|63.34|||<|0.0001|2-Sided|90.0|53.47|75.04|||Mixed Models Analysis||||
1607473|NCT02625207|2952718|Superiority or Other||Adjusted Geometric Mean Ratio|85.84|||<|0.137|2-Sided|90.0|72.46|101.68|||Mixed Models Analysis||||
1607474|NCT02625207|2952718|Superiority or Other||Adjusted Geometric Mean Ratio|116.65|||<|0.1338|2-Sided|90.0|98.47|138.18|||Mixed Models Analysis||||
1607475|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|97.21||||0.7913|2-Sided|90.0|81.29|116.25|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.|
1607476|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|84.05||||0.1099|2-Sided|90.0|70.29|100.52|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.|
1607477|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|99.6||||0.9708|2-Sided|90.0|82.95|119.59|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.|
1607478|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|118.5||||0.1261|2-Sided|90.0|98.69|142.28|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.|
1607479|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|97.6||||0.8241|2-Sided|90.0|81.28|117.18|||Mixed Models Analysis|||Statistical analysis of PF -06927573 was estimated and reported.|
1607480|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|100.73||||0.9536|2-Sided|90.0|81.69|124.22|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.|
1607481|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|96.11||||0.752|2-Sided|90.0|77.94|118.52|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.|
1607482|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|101.03||||0.9363|2-Sided|90.0|81.54|125.18|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.|
1607483|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|105.12||||0.6974|2-Sided|90.0|84.84|130.24|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.|
1607484|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|99.7||||0.9816|2-Sided|90.0|80.47|123.53|||Mixed Models Analysis|||Statistical analysis of PF -06927572 was estimated and reported.|
1607485|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|119.61||||0.059|2-Sided|90.0|102.42|139.69|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.|
1607486|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|106.69||||0.4866|2-Sided|90.0|91.36|124.6|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.|
1607487|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|108.52||||0.3913|2-Sided|90.0|92.6|127.17|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.|
1607488|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|101.71||||0.8583|2-Sided|90.0|86.79|119.2|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.|
1607623|NCT02621060|2952997|Superiority||Mean Difference (Final Values)|0.05||||0.022|2-Sided|5.0|||||Wilcoxon (Mann-Whitney)||||
1607489|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|110.22||||0.3081|2-Sided|90.0|94.05|129.18|||Mixed Models Analysis|||Statistical analysis of PF -6857640 was estimated and reported.|
1607490|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|272.07|||<|0.0001|2-Sided|90.0|224.08|330.33|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.|
1607491|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|120.99|||<|0.1061|2-Sided|90.0|99.65|146.9|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.|
1607492|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|198.49|||<|0.0001|2-Sided|90.0|162.77|242.05|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.|
1607493|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|164.06|||<|0.0001|2-Sided|90.0|134.54|200.06|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.|
1607494|NCT02625207|2952719|Superiority or Other||Adjusted Geometric Mean Ratio|137.07|||<|0.0106|2-Sided|90.0|112.4|167.15|||Mixed Models Analysis|||Statistical analysis of PF -6857639 was estimated and reported.|
1607495|NCT02625207|2952720|Superiority or Other||Adjusted Geometric Mean Ratio|82.59||||0.0531|2-Sided|90.0|70.33|96.98|||Mixed Models Analysis||||
1607496|NCT02625207|2952721|Superiority or Other||Adjusted Geometric Mean ratio|73.99||||0.0038|2-Sided|90.0|62.7|87.31|||Mixed Models Analysis||||
1607497|NCT02625207|2952721|Superiority or Other||Adjusted Geometric Mean Ratio|73.83||||0.0036|2-Sided|90.0|62.57|87.13|||Mixed Models Analysis||||
1607498|NCT02625207|2952721|Superiority or Other||Adjusted Geometric Mean Ratio|63.38|||<|0.0001|2-Sided|90.0|53.51|75.07|||Mixed Models Analysis||||
1607499|NCT02625207|2952721|Superiority or Other||Adjusted Geometric Mean Ratio|85.85|||<|0.1369|2-Sided|90.0|72.48|101.68|||Mixed Models Analysis||||
1607500|NCT02625207|2952721|Superiority or Other||Adjusted Geometric Mean Ratio|116.73|||<|0.1318|2-Sided|90.0|98.55|138.26|||Mixed Models Analysis||||
1607501|NCT02624284|2952775|Superiority|Analysis: Multiple regression predicting main effects of dose on days of abstinence. Age, sex, race and nicotine dependence were included as covariates.||||||0.78|||||||Regression, Linear||||
1607502|NCT02624284|2952777|Superiority|Analysis: Multiple regression predicting main effects of dose on number of cigarettes smoked. Age, sex, race, nicotine dependence, and pre-session craving for negative affect relief (QSU-B Factor 2) were included as covariates.||||||0.53|||||||Regression, Linear||||
1607503|NCT02624284|2952778|Superiority|Analysis: Multiple regression predicting main effects of dose on latency to smoke. Age, sex, race, nicotine dependence, and pre-session craving for negative affect relief (QSU-B Factor 2) were included as covariates.||||||0.94|||||||Regression, Linear||||
1607504|NCT02624050|2952783|Superiority|||||||0.277||||||"Because the data were skewed, the natural logarithmic transformation was used prior to analysis for inference.~Threshold for statistical significance was <0.05"|Ratio of Geometric Means|This p-value is for 15 min after induction of anesthesia|||
1607505|NCT02624050|2952788|Superiority||Risk Ratio (RR)|1.0||||0.37|2-Sided|||||Threshold of significance was <0.05|log binomial regression||||
1607506|NCT02624050|2952789|Superiority||Risk Ratio (RR)|1.0||||0.01|2-Sided|||||Threshold for significance was p<0.05.|log-binomial regression||||
1607507|NCT02623855|2952795|Superiority|||||||0.1749|||||||t-test, 2 sided||||
1607508|NCT02623855|2952797|Superiority|||||||0.0085|||||||t-test, 2 sided||||
1607509|NCT02623855|2952799|Superiority|Our hypothesis was that park prescriptions with group visits would have a superior result than park prescriptions alone.||||||0.6099|||||||t-test, 2 sided|||The study is powered for our primary outcome, caregiver stress as measured by the 10-item perceived stress s score (PSS10). Normative data from population samples show a mean PSS10 score of 13.2 points with a standard deviation of 6.35 points and a within-subject correlation coefficient of 0.77 over 2 weeks.We powered the study to detect a three point difference in the change of the PSS10. This effect size is consistent with other estimates of a clinically significant change.|
1607510|NCT02623803|2952801|Superiority|||||||0.8927|||||||Wilcoxon (Mann-Whitney)||||
1607511|NCT02623803|2952802|Superiority|||||||0.8339|||||||Wilcoxon (Mann-Whitney)||||
1607512|NCT02623803|2952803|Superiority|||||||0.5107|||||||Wilcoxon (Mann-Whitney)||||
1607513|NCT02623803|2952804|Superiority|||||||0.7073|||||||Wilcoxon (Mann-Whitney)||||
1607514|NCT02623803|2952805|Superiority|||||||0.4194|||||||Wilcoxon (Mann-Whitney)||||
1607515|NCT02623803|2952806|Superiority|||||||0.9171|||||||Wilcoxon (Mann-Whitney)||||
1607516|NCT02623803|2952807|Superiority|||||||0.2363|||||||Wilcoxon (Mann-Whitney)||||
1607517|NCT02623803|2952808|Superiority|||||||0.3166|||||||Wilcoxon (Mann-Whitney)||||
1607518|NCT02623803|2952809|Superiority|||||||0.5314|||||||Wilcoxon (Mann-Whitney)||||
1607519|NCT02623803|2952810|Superiority|||||||0.0404|||||||Wilcoxon (Mann-Whitney)||||
1607520|NCT02623803|2952811|Superiority|||||||0.3057|||||||Wilcoxon (Mann-Whitney)||||
1607521|NCT02623803|2952812|Superiority|||||||0.2196|||||||Wilcoxon (Mann-Whitney)||||
1607522|NCT02623803|2952813|Superiority|||||||0.3136|||||||Wilcoxon (Mann-Whitney)||||
1607523|NCT02623803|2952814|Superiority|||||||0.1029|||||||Wilcoxon (Mann-Whitney)||||
1607524|NCT02623803|2952815|Superiority|||||||0.0697|||||||Wilcoxon (Mann-Whitney)||||
1607525|NCT02623803|2952816|Superiority|||||||0.5285|||||||Wilcoxon (Mann-Whitney)||||
1607526|NCT02623803|2952817|Superiority|||||||0.3989|||||||Wilcoxon (Mann-Whitney)||||
1607527|NCT02623803|2952818|Superiority|||||||0.205|||||||Wilcoxon (Mann-Whitney)||||
1607528|NCT02623803|2952819|Superiority|||||||0.1459|||||||Wilcoxon (Mann-Whitney)||||
1607529|NCT02623725|2952832|Superiority|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was >1.|Geometric mean of titer ratio|1.33|||||2-Sided|95.0|1.02|1.73||||||Dengue Virus Serotype 4|
1607530|NCT02623725|2952832|Superiority|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was >1.|Geometric mean of titer ratio|1.06|||||2-Sided|95.0|0.86|1.3||||||Dengue Virus Serotype 3|
1607624|NCT02621060|2952998|Superiority||Mean Difference (Final Values)|0.05||||0.022|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1607531|NCT02623725|2952832|Superiority|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was >1.|Geometric mean of titer ratio|1.89|||||2-Sided|95.0|1.49|2.41||||||Dengue Virus Serotype 2|
1607532|NCT02623725|2952832|Superiority|The superiority was to be demonstrated if the lower limit of the two-sided 95% CI for the ratio was >1.|Geometric mean of titer ratio|1.66|||||2-Sided|95.0|1.34|2.05||||||Dengue Virus Serotype 1|
1607533|NCT02623725|2952833|Non-Inferiority|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was >1/2 for each serotype.|Geometric mean of titer ratio|1.32|||||2-Sided|95.0|1.01|1.74||||||Dengue Virus Serotype 4|
1607534|NCT02623725|2952833|Non-Inferiority|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was >1/2 for each serotype.|Geometric mean of titer ratio|1.04|||||2-Sided|95.0|0.841|1.27||||||Dengue Virus Serotype 3|
1607535|NCT02623725|2952833|Non-Inferiority|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95% CI of the GMTRs (booster vs post-dose 3) was >1/2 for each serotype.|Geometric mean of titer ratio|1.82|||||2-Sided|95.0|1.43|2.31||||||Dengue Virus Serotype 2|
1607536|NCT02623725|2952833|Non-Inferiority|The overall non-inferiority of the booster dose was to be demonstrated if the lower limit of the two-sided 95 percent (%) Confidence Interval (CI) of the Geometric mean of titer ratios (GMTRs) (booster vs post-dose 3) was greater than (>) 1/2 for each serotype.|Geometric mean of titer ratio|1.66|||||2-Sided|95.0|1.33|2.06||||||Dengue Virus Serotype 1|
1607537|NCT02623348|2952846|Superiority||||||<|0.01||||||Threshold for significance: <0.05|linear mixed modeling||||
1607538|NCT02623335|2952847|Superiority||Effect estimate|5.04||||0.07|2-Sided||||||Mixed Models Analysis||||
1607539|NCT02623335|2952849|Superiority||Effect estimate|0.94||||0.053|2-Sided||||||Mixed Models Analysis|||3-4 months post-enrollment post-enrollment (T3)|
1607540|NCT02623335|2952849|Superiority||Effect estimate|1.16||||0.022|2-Sided||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)|
1607541|NCT02623335|2952850|Superiority||Effect estimate|1.12||||0.019|2-Sided||||||Mixed Models Analysis|||3-4 months post-enrollment (T3)|
1607542|NCT02623335|2952850|Superiority||Effect estimate|0.97||||0.034|2-Sided||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)|
1607543|NCT02623335|2952851|Superiority||Effect estimate|-1.12||||0.007|2-Sided||||||Mixed Models Analysis|||3-4 months post-enrollment post-enrollment (T3)|
1607544|NCT02623335|2952851|Superiority||Effect estimate|-0.72||||0.106|2-Sided||||||Mixed Models Analysis|||6-8 weeks post-enrollment (T2)|
1607545|NCT02623335|2952852|Superiority||Effect estimate|-0.25||||0.009|2-Sided||||||Mixed Models Analysis||||
1607546|NCT02623335|2952853|Superiority||Odds Ratio (OR)|1.39||||0.412|2-Sided||||||Mixed Models Analysis||||
1607547|NCT02623335|2952854|Superiority||Effect estimate|-0.37||||0.411|2-Sided||||||Mixed Models Analysis||||
1607548|NCT02623335|2952855|Superiority||Effect estimate|-0.15||||0.645|2-Sided||||||Mixed Models Analysis|||Change in scores between T3 and T1|
1607549|NCT02623335|2952855|Superiority||Effect estimate|-0.04||||0.84|2-Sided||||||Mixed Models Analysis|||Change in scores between T2 and T1|
1607550|NCT02623335|2952856|Superiority||Odds Ratio (OR)|239047259.0||||0.094|2-Sided||||||Mixed Models Analysis|||Advance directives questions|
1607551|NCT02623335|2952856|Superiority||Odds Ratio (OR)|1.41||||0.255|2-Sided||||||Mixed Models Analysis|||Risks questions|
1607552|NCT02623335|2952856|Superiority||Odds Ratio (OR)|0.97||||0.923|2-Sided||||||Mixed Models Analysis|||Expectations questions|
1607553|NCT02623335|2952856|Superiority||Odds Ratio (OR)|1.32||||0.353|2-Sided||||||Mixed Models Analysis|||Options questions|
1607554|NCT02623322|2952858|Superiority||Hazard Ratio (HR)|0.74||||0.2044|2-Sided|80.0|0.53|1.04|||Wilcoxon|||Total Symptom Score of <=7|
1607555|NCT02623322|2952858|Superiority||Hazard Ratio (HR)|0.63||||0.0312|2-Sided|80.0|0.45|0.89|||Wilcoxon|||Total Symptom Score of <=7|
1607556|NCT02623322|2952858|Superiority||Hazard Ratio (HR)|0.9||||0.517|2-Sided|80.0|0.59|1.36|||Wilcoxon|||Total Symptom Score of <=1|
1607557|NCT02623322|2952858|Superiority||Hazard Ratio (HR)|0.92||||0.7858|2-Sided|80.0|0.62|1.37|||Wilcoxon|||Total Symptom Score of <=1|
1607558|NCT02623322|2952862|Superiority||Difference in event rates (Wald)|-3.03||||0.3324|2-Sided|80.0|-12.82|6.76|||Cochran-Mantel-Haenszel||||
1607559|NCT02623322|2952862|Superiority||Difference in event rates (Wald)|-3.03||||0.3031|2-Sided|80.0|-12.25|6.19|||Cochran-Mantel-Haenszel||||
1607560|NCT02623322|2952863|Superiority||Difference in event rates (Wald)|-3.03||||0.3324|2-Sided|80.0|-12.82|6.76|||Cochran-Mantel-Haenszel||||
1607561|NCT02623322|2952863|Superiority||Difference in event rates (Wald)|-3.03||||0.3031|2-Sided|80.0|-12.25|6.19|||Cochran-Mantel-Haenszel||||
1607562|NCT02622724|2952874|Other||Least Squares Mean|28.0|||>|0.05|2-Sided|95.0|-54.0|110.1|||ANOVA|||Treatment effect was analysed using ANOVA parameter estimates (Least Squares Means and 95 % Confidence Intervals) for the overall treatment difference for maximun distance walked on Day 360.|
1607563|NCT02622724|2952877|Other||||||<|0.007||||||The p-value is not adjusted for multiple comparisons.|Chi-squared||||
1607564|NCT02622724|2952878|Other||LS Means difference|0.0|||>|0.05|1-Sided||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||TNF-α - changes in levels from baseline to Day 14|
1607565|NCT02622724|2952878|Other||LS Means difference|0.0|||<|0.05|1-Sided||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IP-10 - changes in levels from baseline to Day 14.|
1607566|NCT02622724|2952878|Other||LS Means difference|0.0|||<|0.05|1-Sided|95.0|||||ANCOVA|ANCOVA estimates (LS means and a 95% CI for the treatment difference) were presented for all numeric biomarker variables.||FGF basic - changes in levels from baseline to Day 14|
1607567|NCT02622724|2952878|Other||LS Means difference|0.0|||>|0.05|1-Sided||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IL- 6 - changes in levels from baseline to Day 14|
1607625|NCT02621060|2952999|Superiority or Other|||||||0.022|||||||Wilcoxon (Mann-Whitney)||||
1607568|NCT02622724|2952878|Other||LS Means difference|0.0|||>|0.05|1-Sided||||||ANCOVA|ANCOVA estimates (LS means and a 95 % CI for the treatment difference) were presented for all numeric biomarker variables.||IL -1ra - changes in levels from baseline to Day 14|
1607569|NCT02622724|2952892|Other||Least Squares Mean|31.1|||>|0.05|2-Sided|95.0|-37.7|99.9|||ANOVA|||Treatment effect was analysed using ANOVA parameter estimates (Least Squares Means and 95% Confidence Intervals) for the overall treatment difference for maximum distance walked on Day 180.|
1607570|NCT02622724|2952895|Superiority||||||<|0.05|||||||ANCOVA|Analysis of covariance (ANCOVA) model using Type III sums of squares with Treatment, Severity, and Country fixed effect factors, Baseline as covariate|||
1607571|NCT02622724|2952900|Superiority|||||||0.4678|||||||Van Elteren p-values|||Van Elteren hypothesis test was used as the distribution was non-normal and negatively skewed by patients who are assigned scores of zero in the event of death.|
1607572|NCT02622724|2952907|Superiority|||||||0.8219|||||||Van Elteren hypothesis test|||A non-parametric analysis has been used as the data distribution was skewed. This involved a generalised Wilcoxon rank sum-based stratification test which assigns ranks within strata and compares two treatments within strata (Van Elteren hypothesis test).|
1607573|NCT02622568|2952908|Non-Inferiority|Comparison at week 0|Mean Difference (Final Values)|-0.222||||0.81|2-Sided||||||t-test, 2 sided||||
1607574|NCT02622568|2952908|Non-Inferiority|Veregen alone has efficacy compared to Veregen + cryotherapy|Mean Difference (Final Values)|1.556||||0.383|2-Sided|||||Comparison at week 12|t-test, 2 sided||||
1607575|NCT02622321|2952912|Superiority or Other (legacy)||Adjusted Mean Difference|-0.16||||0.0014|2-Sided|95.0|-0.25|-0.07||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 29. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.|
1607576|NCT02622321|2952913|Superiority or Other (legacy)||Adjusted Mean Difference|-9.72||||0.0171|2-Sided|95.0|-17.62|-1.82||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 29. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.|
1607577|NCT02622321|2952914|Superiority or Other (legacy)||Adjusted Mean Difference|14.01||||0.0019|2-Sided|95.0|5.56|22.45||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 25. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm.|
1607578|NCT02622321|2952915|Superiority or Other (legacy)||Adjusted Mean Difference|21.55||||0.0029|2-Sided|95.0|7.89|35.22||Statistical significance was controlled at a two-sided alpha level of 0.05.|ANCOVA|||Actual number of participants included for inferential statistics in Arm A is 25. Means adjusted for covariates: baseline score, treatment group and treatment by baseline interaction arm. Analysis was performed using Analysis of Covariance (ANCOVA).|
1607579|NCT02622321|2952916|Superiority or Other (legacy)||ABR Ratio|0.05||||0.0002|2-Sided|95.0|0.009|0.227||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant’s number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (<9 or >/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.|
1607580|NCT02622321|2952917|Superiority or Other (legacy)||ABR Ratio|0.08|||<|0.0001|2-Sided|95.0|0.037|0.154||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant’s number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (<9 or >/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.|
1607581|NCT02622321|2952918|Superiority or Other (legacy)||ABR Ratio|0.21||||0.0003|2-Sided|95.0|0.089|0.486||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for treated bleeds was performed using an NB regression model.|
1607582|NCT02622321|2952919|Superiority or Other (legacy)||ABR Ratio|0.23|||<|0.0001|2-Sided|95.0|0.119|0.435||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for all bleeds was performed using an NB regression model.|
1607583|NCT02622321|2952920|Superiority or Other (legacy)||ABR Ratio|0.11||||0.005|2-Sided|95.0|0.025|0.52||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant’s number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (<9 or >/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.|
1607584|NCT02622321|2952921|Superiority or Other (legacy)||ABR Ratio|0.08|||<|0.0001|2-Sided|95.0|0.031|0.198||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for treated bleeds was performed using an NB regression model.|
1607585|NCT02622321|2952922|Superiority or Other (legacy)||ABR Ratio|0.11|||<|0.0001|2-Sided|95.0|0.055|0.218||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Non-Stratified Wald Test|||This intra-participant comparison of ABR for all bleeds was performed using an NB regression model.|
1607586|NCT02622321|2952923|Superiority or Other (legacy)||ABR Ratio|0.2|||<|0.0001|2-Sided|95.0|0.102|0.375||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant’s number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (<9 or >/=9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.|
1607587|NCT02622321|2952924|Superiority or Other (legacy)||ABR Ratio|0.13|||<|0.0001|2-Sided|95.0|0.057|0.277||Statistical significance was controlled at a two-sided alpha level of 0.05 based on a Wald testing procedure.|Stratified Wald Test|||Analysis was performed using an NB regression model, which accounted for different follow-up times, with the participant’s number of bleeds as a function of randomization and the time that each participant stays in the study included as an offset in the model. The model also included the number of bleeds (less than [<] 9 or greater than or equal to [>/=] 9) in the last 24 weeks prior to study entry as a stratification factor in the randomization.|
1607588|NCT02621931|2952956|Superiority||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.|
1607589|NCT02621931|2952956|Superiority||||||<|0.0004||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.|
1607590|NCT02621931|2952957|Superiority||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.|
1607591|NCT02621931|2952957|Superiority||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.|
1607592|NCT02621931|2952958|Superiority||LSM difference from placebo|-2.3|Standard Error of the Mean|0.31|<|0.0001|2-Sided|95.0|-2.95|-1.73||0.05 level of significance|ANCOVA||||
1607593|NCT02621931|2952959|Superiority||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.|
1607594|NCT02621931|2952959|Superiority||||||<|0.0001||||||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.|
1607595|NCT02621931|2952960|Superiority||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Overall|
1607596|NCT02621931|2952960|Superiority||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Overall|
1607597|NCT02621931|2952960|Superiority||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 3|
1607598|NCT02621931|2952960|Superiority||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 3|
1607599|NCT02621931|2952960|Superiority||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 2|
1607600|NCT02621931|2952960|Superiority||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 2|
1607601|NCT02621931|2952960|Superiority||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 1: Active 675/225/225 to Placebo|
1607602|NCT02621931|2952960|Superiority||||||<|0.0001||||||0.05 level of significance. P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.|Cochran-Mantel-Haenszel|||Month 1: Active 675/placebo/placebo to Placebo|
1607603|NCT02621931|2952961|Superiority||LSM difference from placebo|-1.8|Standard Error of the Mean|0.39|<|0.0001|2-Sided|95.0|-2.61|-1.09||0.05 level of significance|ANCOVA||||
1607604|NCT02621931|2952961|Superiority||LSM difference from placebo|-1.7|Standard Error of the Mean|0.39|<|0.0001|2-Sided|95.0|-2.48|-0.97||0.05 level of significance|ANCOVA||||
1607605|NCT02621931|2952963|Superiority||LSM difference from placebo|-2.1|Standard Error of the Mean|0.33|<|0.0001|2-Sided|95.0|-2.76|-1.45||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.|
1607606|NCT02621931|2952963|Superiority||LSM difference from placebo|-1.8|Standard Error of the Mean|0.33|<|0.0001|2-Sided|95.0|-2.46|-1.15||0.05 level of significance|Wilcoxon (Mann-Whitney)|||Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the statistical analysis plan (SAP).|
1607607|NCT02621892|2952964|Superiority||Risk Difference (RD)|10.9|||<|0.003|2-Sided||||||Cochran-Mantel-Haenszel||||
1607608|NCT02621892|2952965|Superiority||Risk Difference (RD)|11.92|||<|0.001|2-Sided||||||Cochran-Mantel-Haenszel||||
1607609|NCT02621892|2952966|Superiority||Risk Difference (RD)|10.34|||<|0.001|2-Sided||||||Cochran-Mantel-Haenszel||||
1607610|NCT02621892|2952967|Superiority||Risk Difference (RD)|10.86|||<|0.008|2-Sided||||||Cochran-Mantel-Haenszel||||
1607611|NCT02621892|2952969|Superiority||Risk Difference (RD)|8.31|||<|0.02|2-Sided||||||Cochran-Mantel-Haenszel||||
1607612|NCT02621060|2952986|Superiority or Other|||||||0.637|||||||Wilcoxon (Mann-Whitney)||||
1607613|NCT02621060|2952987|Superiority or Other|||||||0.774|||||||Wilcoxon (Mann-Whitney)||||
1607614|NCT02621060|2952988|Superiority or Other|||||||0.472|||||||Wilcoxon (Mann-Whitney)||||
1607615|NCT02621060|2952989|Superiority or Other|||||||0.376|||||||Wilcoxon (Mann-Whitney)||||
1607616|NCT02621060|2952990|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1607617|NCT02621060|2952991|Superiority or Other|||||||0.049|||||||Wilcoxon (Mann-Whitney)||||
1607618|NCT02621060|2952992|Superiority or Other|||||||0.059|||||||Wilcoxon (Mann-Whitney)||||
1607619|NCT02621060|2952993|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1607620|NCT02621060|2952994|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1607621|NCT02621060|2952995|Superiority or Other|||||||0.42|||||||Wilcoxon (Mann-Whitney)||||
1607626|NCT02621060|2953000|Superiority or Other|||||||0.074|||||||Wilcoxon (Mann-Whitney)||||
1607627|NCT02621060|2953002|Superiority or Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)||||
1607628|NCT02621060|2953003|Superiority or Other|||||||0.084|||||||Wilcoxon (Mann-Whitney)||||
1607629|NCT02621060|2953004|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1607630|NCT02621060|2953005|Superiority or Other|||||||0.755|||||||Wilcoxon (Mann-Whitney)||||
1607631|NCT02621060|2953006|Superiority or Other|||||||0.084|||||||Wilcoxon (Mann-Whitney)||||
1607632|NCT02621060|2953007|Superiority or Other||Median Difference (Final Values)|0.05|Standard Deviation|2.0||0.004|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1607633|NCT02621047|2953017|Superiority or Other||Geometric Mean Ratio %|158.0|||||2-Sided|90.0|91.2|274.0|||||||
1607634|NCT02621047|2953017|Superiority or Other||Geometric Mean Ratio %|137.0|||||2-Sided|90.0|100.0|186.0|||||||
1607635|NCT02621047|2953018|Superiority or Other||Geometric Mean Ratio %|180.0||||||90.0|97.2|334.0|||||||
1607636|NCT02621047|2953018|Superiority or Other||Geometric Mean Ratio %|139.0|||||2-Sided|90.0|94.8|203.0|||||||
1607637|NCT02621047|2953019|Superiority or Other||Geometric Mean Ratio %|55.8||||||90.0|26.0|120.0|||||||
1607638|NCT02621047|2953019|Superiority or Other||Geometric Mean Ratio %|96.6||||||90.0|69.9|134.0|||||||
1607639|NCT02621047|2953020|Superiority or Other||Geometric Mean Ratio %|57.5|||||2-Sided|90.0|20.0|165.0|||||||
1607640|NCT02621047|2953020|Superiority or Other||Geometric Mean Ratio %|73.3|||||2-Sided|90.0|46.2|116.0|||||||
1607641|NCT02621047|2953021|Superiority or Other||Geometric Mean Ratio %|157.0|||||2-Sided|90.0|91.8|268.0|||||||
1607642|NCT02621047|2953021|Superiority or Other||Geometric Mean Ratio %|134.0||||||90.0|99.6|181.0|||||||
1607643|NCT02621047|2953022|Superiority or Other||Geometric Mean Ratio %|176.0||||||90.0|98.4|315.0|||||||
1607644|NCT02621047|2953022|Superiority or Other||Geometric Mean Ratio %|136.0|||||2-Sided|90.0|94.7|196.0|||||||
1607645|NCT02621047|2953023|Superiority or Other||Geometric Mean Ratio %|63.7|||||2-Sided|90.0|34.0|119.0|||||||
1607646|NCT02621047|2953023|Superiority or Other||Geometric Mean Ratio %|104.0||||||90.0|76.8|141.0|||||||
1607647|NCT02621047|2953024|Superiority or Other||Geometric Mean Ratio %|65.6|||||2-Sided|90.0|26.9|160.0|||||||
1607648|NCT02621047|2953024|Superiority or Other||Geometric Mean Ratio %|80.6||||||90.0|50.2|130.0|||||||
1607649|NCT02621047|2953025|Superiority or Other||Geometric Mean Ratio %|96.6|||||2-Sided|90.0|55.6|168.0|||||||
1607650|NCT02621047|2953025|Superiority or Other||Geometric Mean Ratio %|115.0|||||2-Sided|90.0|85.2|154.0|||||||
1607651|NCT02621047|2953026|Superiority or Other||Geometric Mean Ratio %|98.1||||||90.0|51.7|186.0|||||||
1607652|NCT02621047|2953026|Superiority or Other||Geometric Mean Ratio %|116.0||||||90.0|78.6|172.0|||||||
1607653|NCT02621047|2953027|Superiority or Other||Geometric Mean Ratio %|59.0||||||90.0|34.2|102.0|||||||
1607654|NCT02621047|2953027|Superiority or Other||Geometric Mean Ratio %|85.1||||||90.0|55.5|130.0|||||||
1607655|NCT02621047|2953028|Superiority or Other||Geometric Mean Ratio %|60.8|||||2-Sided|90.0|26.6|139.0|||||||
1607656|NCT02621047|2953028|Superiority or Other||Geometric Mean Ratio %|64.6||||||90.0|36.2|115.0|||||||
1607657|NCT02621047|2953029|Superiority or Other||Geometric Mean Ratio %|296.0|||||2-Sided|90.0|174.0|506.0|||||||
1607658|NCT02621047|2953029|Superiority or Other||Geometric Mean Ratio %|189.0||||||90.0|121.0|293.0|||||||
1607659|NCT02621047|2953030|Superiority or Other||Geometric Mean Ratio %|228.0||||||90.0|129.0|403.0|||||||
1607660|NCT02621047|2953030|Superiority or Other||Geometric Mean Ratio %|162.0|||||2-Sided|90.0|104.0|254.0|||||||
1607661|NCT02621047|2953031|Superiority or Other||Geometric Mean Ratio %|285.0||||||90.0|175.0|466.0|||||||
1607662|NCT02621047|2953031|Superiority or Other||Geometric Mean Ratio %|186.0||||||90.0|122.0|281.0|||||||
1607663|NCT02621047|2953032|Superiority or Other||Geometric Mean Ratio %|220.0||||||90.0|131.0|369.0|||||||
1607664|NCT02621047|2953032|Superiority or Other||Geometric Mean Ratio %|160.0||||||90.0|105.0|243.0|||||||
1607665|NCT02621047|2953033|Superiority or Other||Geometric Mean Ratio %|130.0|||||2-Sided|90.0|75.4|225.0|||||||
1607666|NCT02621047|2953033|Superiority or Other||Geometric Mean Ratio %|148.0|||||2-Sided|90.0|106.0|208.0|||||||
1607667|NCT02621047|2953034|Superiority or Other||Geometric Mean Ratio %|100.0|||||2-Sided|90.0|55.1|183.0|||||||
1607668|NCT02621047|2953034|Superiority or Other||Geometric Mean Ratio Percentage (%)|128.0|||||2-Sided|90.0|86.5|188.0|||||||
1607669|NCT02620683|2953056|Other||Median Difference (Final Values)|-1.0||||0.23|2-Sided|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)|||The difference between injection type– 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon signed rank tests (SAS v 9.3). Statistical significance was set as P < 0.05 for all outcomes.|
1607670|NCT02620683|2953057|Other||Mean Difference (Final Values)|-0.66||||0.096|2-Sided|95.0|-1.46|0.13|||t-test, 2 sided|||The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using ProcTTEST (SAS v 9.3). Statistical significance was set as P < 0.05 for all outcomes.|
1607671|NCT02620683|2953058|Other||Median Difference (Final Values)|-15.0||||0.006|2-Sided|95.0|-34.6|-5.86|||Wilcoxon (Mann-Whitney)||for a cross over design difference in blood level was calculate buffered lidocaine minus non-buffered lidocaine|The difference between injection type– 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon signed rank tests (SAS v 9.3). Statistical significance was set as P < 0.05 for all outcomes.|
1607672|NCT02620384|2953059|Superiority|||||||0.559|||||||Chi-squared||||
1607673|NCT02620384|2953060|Superiority|||||||0.08|||||||Chi-squared||||
1607674|NCT02620384|2953061|Superiority|||||||0.403|||||||Chi-squared||||
1607675|NCT02620384|2953062|Superiority|||||||0.804|||||||Chi-squared||||
1607676|NCT02620384|2953063|Superiority||Mean Difference (Final Values)|0.106|Standard Error of the Mean|0.734||0.885|2-Sided|95.0|-1.346|1.558|||t-test, 2 sided||||
1607677|NCT02620384|2953064|Superiority|||||||0.171|||||||Chi-squared||||
1607678|NCT02620384|2953065|Superiority|||||||0.144|||||||Chi-squared||||
1607679|NCT02620384|2953066|Superiority||Mean Difference (Final Values)|3.6903|Standard Error of the Mean|72.4074||0.959|2-Sided|95.0|-1395694.0|147.1545|||t-test, 2 sided||||
1607680|NCT02620384|2953067|Superiority||Mean Difference (Final Values)|-0.6955|Standard Error of the Mean|0.2806||0.014|2-Sided|95.0|-1.2506|-0.1403||Represents BORG_48_hours|t-test, 2 sided||Method of estimation is for 48 hour measure.||
1607681|NCT02620384|2953068|Superiority||Mean Difference (Final Values)|-2.717121|Standard Error of the Mean|0.586647|<|0.0001|2-Sided|95.0|-3.8637732|-1.54651|||t-test, 2 sided||||
1607682|NCT02620384|2953069|Superiority||Mean Difference (Final Values)|-2249.3294|Standard Error of the Mean|608.2782|<|0.0001|2-Sided|95.0|-3454.4999|-1044.1589|||t-test, 2 sided||||
1607683|NCT02620384|2953070|Superiority||Mean Difference (Final Values)|2439.511|Standard Error of the Mean|646.2707|<|0.0001|2-Sided|95.0|1160.8485|3718.1734|||t-test, 2 sided||||
1607684|NCT02620020|2953071|Superiority|No hypothesis testing done at this analysis.|LS Mean Difference|-0.3|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.59|-0.07|||||||
1607685|NCT02620020|2953071|Superiority|No hypothesis testing done at this analysis.|LS Mean Difference|-0.1|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.41|0.11|||||||
1607686|NCT02620020|2953071|Superiority|No hypothesis testing done at this analysis.|LS Mean Difference|-0.2|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.46|0.07|||||||
1607687|NCT02620020|2953072|Superiority|No hypothesis testing done at this analysis.|LS Mean Difference|-2.5|Standard Error of the Mean|0.72|||2-Sided|95.0|-3.88|-1.06|||||||
1607688|NCT02620020|2953072|Superiority|No hypothesis testing done at this analysis.|LS Mean Difference|-2.0|Standard Error of the Mean|0.72|||2-Sided|95.0|-3.36|-0.54|||||||
1607689|NCT02620020|2953072|Superiority|No hypothesis testing done at this analysis|LS mean difference|-2.2|Standard Error of the Mean|0.73|||2-Sided|95.0|-3.65|-0.77|||||||
1607690|NCT02620020|2953074|Superiority|No hypothesis testing done at this analysis|LS Mean Difference|-0.7|Standard Error of the Mean|0.3|||2-Sided|95.0|-1.26|-0.07|||||||
1607691|NCT02620020|2953074|Superiority|No hypothesis testing done at this analysis.|LS Mean Difference|-0.7|Standard Error of the Mean|0.3|||2-Sided|95.0|-1.32|-0.12|||||||
1607692|NCT02620020|2953074|Superiority|No hypothesis testing done at this analysis.|Least Squares (LS) Mean Difference|-0.3|Standard Error of the Mean|0.31|||2-Sided|95.0|-0.88|0.34|||||||
1607693|NCT02619617|2953085|Other|1.5mg SOM230 s.c. vs. Placebo s.c.|Odds Ratio (OR)|2.033||||0.385|2-Sided|90.0|0.53|7.79|||Regression, Logistic||||
1607694|NCT02619617|2953086|Other|1.5mg SOM230 s.c. vs. Placebo s.c.|Odds Ratio (OR)|1.308||||0.698|2-Sided|90.0|0.419|4.082|||Regression, Logistic||||
1607695|NCT02618772|2953134|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1607696|NCT02618772|2953135|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1607697|NCT02618772|2953136|Superiority or Other|||||||0.086|||||||t-test, 2 sided||||
1607698|NCT02618772|2953137|Superiority or Other|||||||0.08|||||||t-test, 2 sided||||
1607699|NCT02618772|2953138|Superiority or Other|||||||0.015||||||This p value is in reference to the t-test performed for STAI Post Minus STAI Pre.|t-test, 2 sided||||
1607700|NCT02618772|2953139|Superiority or Other|||||||0.004||||||This p value is a t-test of the Post STAI minus Pre STAI variable.|t-test, 2 sided||||
1607701|NCT02618772|2953140|Superiority or Other|||||||0.008||||||This is in reference to the difference between the suturing and baseline measures.|t-test, 2 sided||||
1607702|NCT02618772|2953140|Superiority or Other|||||||0.191||||||This is in reference to the lidocaine measure.|t-test, 2 sided||||
1607703|NCT02618772|2953140|Superiority or Other|||||||0.011||||||This is in reference to the intervention measure.|t-test, 2 sided||||
1607704|NCT02618772|2953140|Superiority or Other|||||||0.185||||||This is in reference to the baseline measure.|t-test, 2 sided||||
1607705|NCT02618772|2953141|Superiority or Other|||||||0.006||||||This is in reference to the difference between the suturing and baseline measures.|t-test, 2 sided||||
1607706|NCT02618772|2953141|Superiority or Other|||||||0.198||||||This is in reference to the lidocaine measure.|t-test, 2 sided||||
1607707|NCT02618772|2953141|Superiority or Other|||||||0.02||||||This is in reference to the intervention measure.|t-test, 2 sided||||
1607708|NCT02618772|2953141|Superiority or Other|||||||0.151||||||This is in reference to the baseline measure.|t-test, 2 sided||||
1607709|NCT02618772|2953142|Superiority or Other|||||||0.036|||||||t-test, 2 sided||||
1607710|NCT02618772|2953143|Superiority or Other|||||||0.026|||||||t-test, 2 sided||||
1607711|NCT02618759|2953144|Superiority|||||||0.1044|||||||Cochran-Mantel-Haenszel||||
1607712|NCT02618759|2953145|Superiority|||||||1|||||||Cochran-Mantel-Haenszel||||
1607713|NCT02618759|2953146|Superiority|||||||0.6962|||||||Cochran-Mantel-Haenszel||||
1607714|NCT02618759|2953147|Superiority|||||||0.1059|||||||Cochran-Mantel-Haenszel||||
1607715|NCT02618759|2953148|Superiority|||||||0.231|||||||Cochran-Mantel-Haenszel||||
1607716|NCT02618759|2953149|Superiority|||||||0.0745|||||||Cochran-Mantel-Haenszel||||
1607717|NCT02618642|2953150|Superiority|comparison was conducted of the results obtained with a different filter (groups v, x, y,||||||0.0014|||||||Kruskal-Wallis||||
1607718|NCT02618642|2953150|Superiority|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||he results in the irradiated group (n=45) and the control group (n=15) were compared|
1607719|NCT02618642|2953151|Superiority|||||||0.1165|||||||Kruskal-Wallis|||comparison was conducted of the results obtained with a different filter (groups v, x, y,|
1607720|NCT02618642|2953151|Superiority|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared.|
1607721|NCT02618642|2953152|Superiority|||||||0.0907|||||||Kruskal-Wallis||||
1607722|NCT02618642|2953152|Superiority|||||||0.9596|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared.|
1607723|NCT02618642|2953153|Superiority|||||||0.4161|||||||Kruskal-Wallis||||
1607724|NCT02618642|2953153|Superiority|||||||0.4669|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) vs the control group (placebo) (n=15) were compared.|
1607725|NCT02618642|2953154|Superiority|||||||0.5361|||||||Kruskal-Wallis|||comparison was conducted of the results obtained with a different filter were compared|
1607726|NCT02618642|2953154|Superiority|||||||0.3879|||||||Wilcoxon (Mann-Whitney)|||the results in the irradiated group (n=45) and the control group (n=15) were compared|
1607727|NCT02618187|2953156|Superiority||Rate difference (SER-287 - placebo)|14.4||||0.6195|2-Sided|95.0|-11.93|40.81|||Fisher Exact||||
1607728|NCT02618187|2953156|Superiority||Rate difference (SER-287 - placebo)|30.9||||0.1783|2-Sided|95.0|0.86|60.96|||Fisher Exact||||
1607729|NCT02618187|2953156|Superiority||Rate difference (SER-287 - placebo)|24.2||||0.1973|2-Sided|95.0|-5.04|53.53|||Fisher Exact||||
1607730|NCT02618187|2953157|Superiority||Rate difference (SER-287 - placebo)|17.6||||0.2579|2-Sided|95.0|-0.47|35.77|||Fisher Exact||||
1607731|NCT02618187|2953157|Superiority||Rate difference (SER-287 - placebo)|40.0||||0.0237|2-Sided|95.0|15.21|64.79|||Fisher Exact||||
1607732|NCT02618187|2953157|Superiority||Rate difference (SER-287 - placebo)|13.3||||0.4923|2-Sided|95.0|-3.87|30.54|||Fisher Exact||||
1607733|NCT02618187|2953158|Superiority|Daily SER-287, After Vanco. Pre-Treat., tested against Weekly SER-287, After Vanco. Pre-Treat., for superiority||||||0.168|||||||Wilcoxon (Mann-Whitney)|1-sided|||
1607734|NCT02618187|2953158|Superiority|Weekly SER-287, After Vanco. Pre-Treat. tested against Weekly SER-287, After Placebo Pre-Treat., for superiority||||||0.009|||||||Wilcoxon (Mann-Whitney)|1-sided|||
1607735|NCT02618187|2953158|Superiority|Weekly SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority||||||0.001|||||||Wilcoxon (Mann-Whitney)|1-sided|||
1607736|NCT02618187|2953158|Superiority|Daily SER-287, After Vanco. Pre-Treat. tested against Daily Placebo, After Placebo Pre-Treat., for superiority||||||0.001|||||||Wilcoxon (Mann-Whitney)|1-sided|||
1607737|NCT02618187|2953158|Superiority|Weekly SER-287, after Placebo Pre-Treat. tested against Daily placebo, after Placebo Pre-Treat., for superiority||||||0.257|||||||Wilcoxon (Mann-Whitney)|1-sided|||
1607738|NCT02618187|2953159|Other|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.237|||||||Wilcoxon (Mann-Whitney)|2-sided|||
1607739|NCT02618187|2953159|Other|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.384|||||||Wilcoxon (Mann-Whitney)|2-sided|||
1607740|NCT02618187|2953159|Other|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.313|||||||Wilcoxon (Mann-Whitney)|2-sided|||
1607741|NCT02618187|2953159|Other|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.037|||||||Wilcoxon (Mann-Whitney)|2-sided|||
1607742|NCT02618187|2953159|Other|Null hypothesis: the two groups compared show no difference in mean ranks Alternative hypothesis: the two groups compared show a difference in mean ranks||||||0.766|||||||Wilcoxon (Mann-Whitney)|2-sided|||
1607743|NCT02617888|2953165|Superiority||Slope|0.08|||<|0.05|2-Sided||||||Regression, Linear||||
1607744|NCT02617628|2953211|Superiority||Cox Proportional Hazard|-0.74486||||0.01|2-Sided|95.0|||||Regression, Cox|||We used Cox proportional hazards regression model to compare the groups on time to reincarceration.|
1607745|NCT02617628|2953212|Equivalence|The odds ratio for relapse versus non-relapse for the AR group relative to the BR group was analyzed, as well as the corresponding odds ratio for unknown relative to non-relapse.|Odds Ratio (OR)|1.56||||0.38|2-Sided|95.0|0.57|4.27|||Regression, Logistic||Threshold for significance was set at p<.05|Based on Lee et al. we estimated a 23-33% group difference in relapse by month 3. Power estimates calculated this estimate with a 2-sided alpha of .05 and a baseline sample size of 100 per group resulted in 80% power to detect a difference of approximately 20% (OR = 2.4) between groups assuming a rate of 50% in the control condition and 10% and 20% attrition by 3- and 6-month follow-ups. For the 86 participants randomized and released, with 80% power; and odds ratio of 3.5.|
1607746|NCT02616783|2953216|Superiority||Difference in LSM|57.0||||0.051|2-Sided|95.0|0.0|115.0|||ANOVA|The p-value, difference in LSM, and its 95% CI were from ANOVA model with treatment as a fixed effect.|||
1607747|NCT02616783|2953217|Superiority||Difference in LSM|52.0||||0.053|2-Sided|95.0|-1.0|106.0|||ANOVA|The p-value, difference in least square means (LSM), and its 95% CI were from ANOVA model with treatment as a fixed effect.|||
1607748|NCT02616783|2953218|Superiority||Difference in percentages|-1.0||||1|2-Sided|95.0|-8.5|9.3|||Fisher Exact|P-values for the superiority test comparing the percentages of participants with HIV-1 RNA < 50 copies/mL were from the Fisher exact test.|Differences in percentages and 95% CI were generated based on exact method.||
1607749|NCT02616783|2953219|Superiority||Difference in percentages|-5.5||||0.18|2-Sided|95.0|-11.8|1.6||P-values for the superiority test comparing the percentages of participants with HIV-1 RNA < 50 copies/mL were from the Fisher exact test.|Fisher Exact||Differences in percentages and 95% CI were generated based on exact method.||
1607750|NCT02616783|2953220|Superiority||Difference in percentages|1.351|||<|0.001|2-Sided|95.0|0.602|2.099|||ANOVA|P-value was calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.||
1607751|NCT02616783|2953221|Superiority||Difference in percentages|1.749|||<|0.001|2-Sided|95.0|0.726|2.771|||ANOVA|P-value was calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.||
1607752|NCT02616783|2953222|Superiority||Difference in percentages|2.036|||<|0.001|2-Sided|95.0|1.168|2.904|||ANOVA|P-value was calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.|The 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.||
1607866|NCT02614196|2953410|Superiority||LSMean Difference|-0.29|Standard Error of the Mean|0.09||0.002|2-Sided|95.0|-0.47|-0.11|||Mixed Models Analysis||||
1607753|NCT02616783|2953223|Superiority||Difference in Percentages|2.427|||<|0.001|2-Sided|95.0|1.337|3.517|||ANOVA|P-value was calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.|The 95% confidence intervals (CI) were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.||
1607754|NCT02616614|2953224|Equivalence|Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).|Mean Difference (Net)|-0.022|||||2-Sided|90.0|-0.087|0.043|||||Equivalence was based on difference in the number of subjects with success. Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).|Bioequivalence was established if the 90% CI for the difference was contained within the interval (-0.20, +0.20).|
1607755|NCT02616614|2953225|Superiority|||||||0.0006|||||||ANOVA||||
1607756|NCT02616614|2953225|Superiority|||||||0.0002|||||||ANOVA||||
1607757|NCT02616614|2953225|Equivalence|Bioequivalence was established if the 90% CI for the difference was contained within the interval [0.80, 1.25] for the PP population.|Mean Difference (Net)|1.0|||||2-Sided|90.0|0.9|1.11|||||||
1607758|NCT02616614|2953226|Superiority||||||<|0.0001|||||||ANOVA||||
1607759|NCT02616614|2953226|Superiority||||||<|0.0001|||||||ANOVA||||
1607760|NCT02616614|2953226|Equivalence|Bioequivalence was established if the 90% CI for the difference was contained within the interval [0.80,1.25] for the PP population.|Mean Difference (Net)|0.95|||<||2-Sided|90.0|0.88|1.03|||||||
1607761|NCT02616601|2953227|Superiority||||||<|0.0001|||||||Fisher Exact||||
1607762|NCT02616601|2953227|Superiority||||||<|0.0001|||||||Fisher Exact||||
1607763|NCT02616601|2953227|Equivalence|If the 90% confidence interval on the percentage difference between generic fluorouracil cream and Carac (fluorouracil) cream lesion clearance were contained within the interval -0.20 to +0.20, and each of these percentages was greater than and statistically different (p<0.05) from the vehicle cream percentage, then generic fluorouracil cream and Carac (fluorouracil) cream were considered to be therapeutically equivalent.|Mean Difference (Net)|0.04|||<||2-Sided|90.0|-11.03|11.11|||||90% Wald's confidence interval with a continuity correction for the difference (Generic Fluorouracil Cream - Carac [Fluorouracil] Cream) in complete clearance rates.||
1607764|NCT02616380|2953237|Other||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.|||
1607765|NCT02616380|2953238|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 24|
1607766|NCT02616380|2953238|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Activity Impairment at Week 12|
1607767|NCT02616380|2953238|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 24|
1607768|NCT02616380|2953238|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Overall Work Impairment at Week 12|
1607769|NCT02616380|2953239|Other||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 24 weeks|
1607770|NCT02616380|2953239|Other||||||<|0.0001|||||||Paired t-test|||Change from Baseline in EQ-5D-3L at 12 weeks|
1607771|NCT02616380|2953240|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 24|
1607772|NCT02616380|2953240|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Mental Component Score at Week 12|
1607773|NCT02616380|2953240|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 24|
1607774|NCT02616380|2953240|Other||||||<|0.0001|||||||Paired t-test|||Change From Baseline in Physical Component Score at Week 12|
1607775|NCT02616380|2953241|Other||||||<|0.0001|||||||Paired t-test|The mean change was tested with a paired t-test without adjusting for baseline disease severity.|||
1607776|NCT02615470|2953299|Superiority||||||=|0||||||a priori alpha = 0.05|Wilcoxon (Mann-Whitney)||||
1607777|NCT02615470|2953300|Superiority|||||||0.048|||||||Wilcoxon (Mann-Whitney)||||
1607778|NCT02615470|2953301|Superiority||||||=|0||||||A priori alpha = 0.05|Wilcoxon (Mann-Whitney)||||
1607779|NCT02615158|2953302|Equivalence|Alpha is set at 0.05 to indicate statistical significance.|Slope|0.03|Standard Error of the Mean|0.21||0.896|2-Sided|95.0|-0.39|0.45|||Mixed Models Analysis||This is to compare responsive parenting group to child safety group.|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|
1607780|NCT02615158|2953302|Equivalence|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|Slope|-0.36|Standard Error of the Mean|0.21||0.056|2-Sided|95.0|-0.78|0.06||Alpha is set at 0.05 for statistical significance.|Mixed Models Analysis||This is to compare maternal lifestyle group to the child safety group.|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|
1607781|NCT02615158|2953303|Equivalence|The 95% CI was estimated. If it does not include 0, it indicates that there is a significant difference by group in the difference.|Slope|0.98|Standard Error of the Mean|4.94||0.804|2-Sided|95.0|-8.76|10.72|||Mixed Models Analysis||This is to compare responsive parenting group to child safety group.|H0 is that there is no significant difference in the change of maternal MVPA between the two groups.|
1607782|NCT02615158|2953303|Equivalence|The 95% CI for the difference in the change between the two groups was estimated. If it does not include 0, it indicates that there is a significant difference by group in the change.|Slope|10.97|Standard Error of the Mean|4.82||0.024|2-Sided|95.0|1.46|20.48|||Mixed Models Analysis||This is to compare the maternal lifestyle group to the child safety group.|H0 is that there is no difference in the change of maternal MVPA over time between the two groups.|
1607783|NCT02615158|2953304|Equivalence|H0 is that there is no difference between the change of MVPA over time between the two groups.|Slope|13.52|Standard Error of the Mean|10.89||0.216|2-Sided|95.0|-7.98|35.03|||Mixed Models Analysis||This is to compare the responsive parenting group to child safety group.||
1607784|NCT02615158|2953304|Equivalence|A 95% CI was estimated. If it does not include 0, it indicates significant difference in change over time between the two groups.|Slope|23.67|Standard Error of the Mean|11.03||0.034|2-Sided|95.0|1.88|45.46||Alpha is set at 0.05.|Mixed Models Analysis||This is for maternal lifestyle group compared to safety control group.|Null hypothesis is there were no differences in the change over time for toddler MVPA across the two groups.|
1607785|NCT02615158|2953305|Equivalence|95% CI for the difference in change over time was estimated. If it does not include 0, it indicates that there is significant difference between the two groups.|Slope|-0.03|Standard Error of the Mean|2.51||0.99|2-Sided|95.0|-4.97|4.91||Alpha is set to 0.05.|Mixed Models Analysis||This is to compare the responsive parenting group to child safety group.|H0 is there is no difference in the change of maternal HEI score over time between the two groups.|
1607786|NCT02615158|2953305|Equivalence|The 95% CI was estimated. If it does not include 0, it indicates that there is significant difference in the change over time between the two groups.|Slope|3.3|Standard Error of the Mean|2.49||0.186|2-Sided|95.0|-1.6|8.2||Alpha is set at 0.05.|Mixed Models Analysis||This is to compare the maternal lifestyle group to the child safety group.|Null hypothesis is that there are no differences between the two groups regarding the change of HEI 2015 score over time.|
1607787|NCT02615158|2953306|Equivalence|95% CI was estimated. If it does not include 0, it indicates that there is a significant difference in the change between the two groups.|Slope|0.82|Standard Error of the Mean|2.39||0.733|2-Sided|95.0|-3.88|5.52|||Mixed Models Analysis||This is to compare the responsive feeding group to child safety group.|H0 is that there is no difference between the responsive parenting and child safety groups in the change of HEI score over time|
1607788|NCT02615158|2953306|Equivalence|The 95% confidence interval (CI) for the difference in the change over time was estimated. If it does not include 0, it indicates significant difference in the change over time.|Slope|3.31|Standard Error of the Mean|2.4||0.168|2-Sided|95.0|-1.4|8.02||Alpha is set at 0.05.|Mixed Models Analysis|||H0 is that there is no difference between maternal lifestyle and child safety groups in the change of HEI 2015 score over time.|
1607789|NCT02615158|2953307|Equivalence|The 95% CI was estimated. If it does not include 0, it means that there is a statistically significant difference in the change over time between the two groups.|Slope|-0.04|Standard Error of the Mean|0.32||0.904|2-Sided|95.0|-0.66|0.59||The alpha for statistical significance was set at 0.05.|Mixed Models Analysis||This is to compare the responsive parenting group to the child safety group.|H0: There are no differences in the change over time between responsive parenting and child safety groups.|
1607790|NCT02615158|2953307|Equivalence|95% confidence interval (CI) was estimated. If the 95% CI does not include 0, it means there is significant difference in the change over time between the two groups.|Slope|-0.11|Standard Error of the Mean|0.32||0.739|2-Sided|95.0|-0.74|0.52||The alpha for statistical significance is set at 0.05|Mixed Models Analysis||This is to compare maternal lifestyle to child safety group.|H0: There is no difference between maternal lifestyle and child safety groups in the change of BMI over time.|
1607791|NCT02615158|2953308|Equivalence|95% CI|Slope|0.16|Standard Error of the Mean|0.12||0.2|2-Sided|95.0|-0.08|0.39||Two-side test|Mixed Models Analysis||This is to compare the Responsive Parenting to the safety intervention group.||
1607792|NCT02615158|2953308|Equivalence|If the 95% confidence interval of the difference in the change over time does not include 0, it means that there is a significant difference in the change over time between the two groups.|Slope|0.07|Standard Error of the Mean|0.12||0.555|2-Sided|95.0|-0.17|0.31||The alpha for statistical significance is set at 0.05.|Mixed Models Analysis||This is to compare change in maternal lifestyle group to child safety group.|H0: There are no differences between the maternal lifestyle and child safety groups in the change in BMI z-score over time. Mixed models included the interaction between time and intervention, accounting for clustering of the repeated measures within each individual.|
1607793|NCT02615145|2953312|Superiority||Mean Difference (Final Values)|-0.09||||0.8842|2-Sided|95.0|-1.271|1.096|||paired t-test|paired t-test of mean difference vs 0||Change from Baseline to Final visit across all participants|
1607794|NCT02615145|2953312|Superiority||difference in LS means|-0.76||||0.4941|2-Sided|95.0|-2.94|1.42||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA||||
1607795|NCT02615145|2953312|Superiority||difference in LS means|-2.65||||0.1741|2-Sided|95.0|-6.48|1.18||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA||||
1607796|NCT02615145|2953312|Superiority||difference in LS means|-1.89||||0.3125|2-Sided|95.0|-5.57|1.79||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA||||
1607797|NCT02615145|2953312|Superiority|||||||0.3869||||||Between group change comparison: overall. The dependent variable in the change of PAM-13 from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA||||
1607798|NCT02615145|2953313|Superiority||Mean Difference (Final Values)|10.13|||<|0.0001|2-Sided|95.0|7.259|12.992|||paired t-test|paired t-test of mean difference versus 0||baseline vs 48 weeks after EOT across all participants|
1607799|NCT02615145|2953313|Superiority||Mean Difference (Final Values)|10.21|||<|0.0001|2-Sided|95.0|8.113|12.299|||paired t-test|paired t-test of mean difference versus 0||Baseline vs 12 weeks after EOT across all participants|
1607800|NCT02615145|2953313|Superiority||Mean Difference (Final Values)|5.64|||<|0.0001|2-Sided|95.0|3.355|7.935|||paired t-test|paired t-test of mean difference from 0||Baseline to EOT across all participants|
1607801|NCT02615145|2953313|Superiority||difference in LS means|0.654|||<|0.792|2-Sided|95.0|-4.23|5.54||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT|
1607802|NCT02615145|2953313|Superiority||difference in LS means|-3.01|||<|0.5347|2-Sided|95.0|-12.6|6.54||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT|
1607803|NCT02615145|2953313|Superiority||difference in LS means|-3.67|||<|0.4256|2-Sided|95.0|-12.7|5.39||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT|
1607804|NCT02615145|2953313|Superiority||||||<|0.7211||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||48 weeks after EoT|
1607867|NCT02614196|2953411|Superiority||LSMean Difference|-1.78|Standard Error of the Mean|0.24|<|0.001|2-Sided|95.0|-2.25|-1.31|||Mixed Models Analysis||||
1607805|NCT02615145|2953313|Superiority||difference in LS means|0.282|||<|0.874|2-Sided|95.0|-3.21|3.77||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT|
1607806|NCT02615145|2953313|Superiority||difference in LS means|-2.33|||<|0.475|2-Sided|95.0|-8.74|4.08||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT|
1607807|NCT02615145|2953313|Superiority||difference in LS means|-2.61|||<|0.4002|2-Sided|95.0|-8.71|3.49||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 weeks after EoT|
1607808|NCT02615145|2953313|Superiority||||||<|0.7016||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||12 Weeks after EoT|
1607809|NCT02615145|2953313|Superiority||difference in LS means|-1.96|||<|0.3462|2-Sided|95.0|-6.06|2.13||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT|
1607810|NCT02615145|2953313|Superiority||difference in LS means|0.324|||<|0.9308|2-Sided|95.0|-7.0|7.64||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT|
1607811|NCT02615145|2953313|Superiority||difference in LS means|2.29|||<|0.5176|2-Sided|95.0|-4.66|9.23||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EoT|
1607812|NCT02615145|2953313|Superiority||||||<|0.5751||||||Between group change comparison: overall. The dependent variable in the change of FACIT-F [0-100] from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||EOT|
1607813|NCT02615145|2953318|Superiority||Mean Difference (Final Values)|10.15|||<|0.0001|2-Sided|95.0|8.936|11.362|||paired t-test|paired t-test of whether difference in means is 0||Week 48 vs Baseline across all participants|
1607814|NCT02615145|2953318|Superiority||Mean Difference (Final Values)|6.37|||<|0.0001|2-Sided|95.0|5.417|7.32|||paired t-test|paired t-test of whether difference in means is 0||Week 12 vs Baseline across all participants|
1607815|NCT02615145|2953318|Superiority||difference in LS means|0.2|||<|0.8373|2-Sided|95.0|-1.7|2.1||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48|
1607816|NCT02615145|2953318|Superiority||difference in LS means|0.07|||<|0.9678|2-Sided|95.0|-3.33|3.47||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48|
1607817|NCT02615145|2953318|Superiority||difference in LS means|-0.13|||<|0.9379|2-Sided|95.0|-3.37|3.11||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48|
1607818|NCT02615145|2953318|Superiority||||||<|0.9785||||||Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 48|
1607819|NCT02615145|2953318|Superiority||difference in LS means|-1.73|||<|0.0489|2-Sided|95.0|-3.46|-0.01||Between group change comparison: 3DAA+RBV - 3DAA. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12|
1607820|NCT02615145|2953318|Superiority||difference in LS means|-0.09|||<|0.9516|2-Sided|95.0|-3.17|2.98||Between group change comparison: 3DAA+RBV - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12|
1607821|NCT02615145|2953318|Superiority||difference in LS means|1.64|||<|0.2704|2-Sided|95.0|-1.28|4.56||Between group change comparison: 3DAA - 2DAA+RBV. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12|
1607822|NCT02615145|2953318|Superiority||||||<|0.111||||||Between group change comparison: overall. The dependent variable is the change of PRISM from Baseline (Visit-Baseline). The analysis is adjusted for Baseline.|ANCOVA|||Week 12|
1607823|NCT02614469|2953359|Superiority or Other||Ratio of Geometric Means|83.4|||||2-Sided|90.0|62.1|112.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.|
1607824|NCT02614469|2953360|Superiority or Other||Ratio of Geometric Means|103.0|||||2-Sided|90.0|90.9|118.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.|
1607825|NCT02614469|2953364|Superiority or Other||Ratio of Geometric Means|99.3|||||2-Sided|90.0|96.9|102.0|||||Fed/Fasted Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.|
1607868|NCT02614196|2953411|Superiority||LSMean Difference|-1.82|Standard Error of the Mean|0.24|<|0.001|2-Sided|95.0|-2.29|-1.36|||Mixed Models Analysis||||
1607869|NCT02614196|2953412|Superiority||LSMean Difference|7.39|Standard Error of the Mean|1.28|<|0.001|2-Sided|95.0|4.88|9.9|||Mixed Models Analysis||||
1608207|NCT02610816|2953682|Superiority|||||||0.36|||||||Mixed Models Analysis||||
1607826|NCT02614469|2953365|Superiority or Other||Ratio of Geometric Means|103.0|||||2-Sided|90.0|98.0|108.0|||||Fed/Fasting Ratio|To assess the effect of food on the PK of urate, analyses of variance (ANOVA) using a linear mixed-effects model was fitted to the natural logarithmic transformation of PK parameters of urate. The linear mixed-effects model will include subject as a random effect, and treatment, period, and sequence as fixed effects. The 90% confidence intervals were constructed for the ratio of geometric means of PK parameters between fed and fasted treatments, based on log-transformed data.|
1607827|NCT02614287|2953368|Superiority||LSMean Difference|3.09|Standard Error of the Mean|1.8||0.88|2-Sided|95.0|-0.46|6.64|||Mixed Models Analysis|||Emotional Function Domain Score|
1607828|NCT02614287|2953368|Superiority||LSMean Difference|1.26|Standard Error of the Mean|1.49||0.399|2-Sided|95.0|-1.67|4.19|||Mixed Models Analysis|||Role Function-Preventive Domain Score|
1607829|NCT02614287|2953368|Superiority||LSMean Difference|1.85|Standard Error of the Mean|1.59||0.247|2-Sided|95.0|-1.29|4.98|||Mixed Models Analysis|||Role Function-Restrictive Domain Score|
1607830|NCT02614287|2953368|Superiority||LSMean Difference|1.98|Standard Error of the Mean|1.55||0.203|2-Sided|95.0|-1.07|5.03|||Mixed Models Analysis|||Total Score|
1607831|NCT02614287|2953369|Superiority||LSMean Difference|0.91|Standard Error of the Mean|2.82||0.747|2-Sided|95.0|-4.65|6.47|||Mixed Models Analysis||||
1607832|NCT02614287|2953370|Superiority||LSMean Difference|-0.19|Standard Error of the Mean|0.1||0.073|2-Sided|95.0|-0.4|0.02|||Mixed Models Analysis||||
1607833|NCT02614287|2953371|Superiority||LSMean Difference|0.04|Standard Error of the Mean|0.51||0.937|2-Sided|95.0|-0.96|1.04|||Mixed Models Analysis||||
1607834|NCT02614287|2953372|Superiority||Odds Ratio (OR)|1.467||||0.063|2-Sided|95.0|0.979|2.197|||CPLRM|CPLRM: Categorical pseudo likelihood-based repeated measures model|||
1607835|NCT02614287|2953373|Superiority||LSMean Difference|0.09|Standard Error of the Mean|0.41||0.835|2-Sided|95.0|-0.72|0.89|||Mixed Models Analysis||||
1607836|NCT02614287|2953374|Superiority||LSMean Difference|-0.86|Standard Error of the Mean|0.46||0.6|2-Sided|95.0|-1.76|0.04|||Mixed Models Analysis||||
1607837|NCT02614287|2953375|Superiority|||||||0.215|||||||Fisher Exact|||TE ADA Positive (TE ADA+)|
1607838|NCT02614287|2953379|Superiority|||||||1|||||||Fisher Exact||||
1607839|NCT02614261|2953389|Superiority|||||||0.29|||||||Cochran-Mantel-Haenszel||||
1607840|NCT02614261|2953389|Superiority|||||||0.263|||||||Cochran-Mantel-Haenszel||||
1607841|NCT02614261|2953390|Superiority||LSMean Difference|-5.49|Standard Error of the Mean|3.88||0.157|2-Sided|95.0|-13.1|2.12|||ANCOVA||||
1607842|NCT02614261|2953390|Superiority||LSMean Difference|-8.74|Standard Error of the Mean|3.9||0.025|2-Sided|95.0|-16.39|-1.08|||ANCOVA||||
1607843|NCT02614261|2953391|Superiority||LSMean Difference|-18.09|Standard Error of the Mean|4.58|<|0.001|2-Sided|95.0|-27.09|-9.09|||Mixed Models Analysis||||
1607844|NCT02614261|2953391|Superiority||LSMean Difference|-22.71|Standard Error of the Mean|4.6|<|0.001|2-Sided|95.0|-31.74|-13.69|||Mixed Models Analysis||||
1607845|NCT02614261|2953392|Superiority||LSMean Difference|-0.28|Standard Error of the Mean|0.1||0.006|2-Sided|95.0|-0.48|-0.08|||Mixed Models Analysis||||
1607846|NCT02614261|2953392|Superiority||LSMean Difference|-0.14|Standard Error of the Mean|0.1||0.181|2-Sided|95.0|-0.34|0.06|||Mixed Models Analysis||||
1607847|NCT02614261|2953393|Superiority||LSMean Difference|-2.01|Standard Error of the Mean|0.38|<|0.001|2-Sided|95.0|-2.77|-1.26|||Mixed Models Analysis||||
1607848|NCT02614261|2953393|Superiority||LSMean Difference|-2.51|Standard Error of the Mean|0.38|<|0.001|2-Sided|95.0|-3.27|-1.76|||Mixed Models Analysis||||
1607849|NCT02614261|2953394|Superiority||LSMean Difference|6.29|Standard Error of the Mean|1.66|<|0.001|2-Sided|95.0|3.03|9.55|||Mixed Models Analysis||||
1607850|NCT02614261|2953394|Superiority||LSMean Difference|5.06|Standard Error of the Mean|1.5|<|0.001|2-Sided|95.0|2.12|7.99|||Mixed Models Analysis||||
1607851|NCT02614261|2953395|Superiority||Odds Ratio (OR)|1.897||||0.276|2-Sided|95.0|0.6|5.998|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥100%|
1607852|NCT02614261|2953395|Superiority||Odds Ratio (OR)|0.761||||0.729|2-Sided|95.0|0.163|3.563|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥100%|
1607853|NCT02614261|2953395|Superiority||Odds Ratio (OR)|1.819||||0.011|2-Sided|95.0|1.146|2.888|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥75%|
1607854|NCT02614261|2953395|Superiority||Odds Ratio (OR)|1.498||||0.102|2-Sided|95.0|0.923|2.43|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥75%|
1607855|NCT02614261|2953395|Superiority||Odds Ratio (OR)|1.788|||<|0.001|2-Sided|95.0|1.291|2.474|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥50%|
1607856|NCT02614261|2953395|Superiority||Odds Ratio (OR)|1.623|||<|0.004|2-Sided|95.0|1.167|2.256|||CPRMM|Categorical pseudo likelihood-based repeated measures model (CPRMM)||Reduction from Baseline ≥50%,|
1607857|NCT02614261|2953396|Superiority||LSMean Difference|-1.88|Standard Error of the Mean|0.42|<|0.001|2-Sided|-1.88|-2.71|-1.05|||Mixed Models Analysis||||
1607858|NCT02614261|2953396|Superiority||LSMean Difference|-2.09|Standard Error of the Mean|0.42|<|0.001|2-Sided|95.0|-2.92|-1.26|||Mixed Models Analysis||||
1607859|NCT02614196|2953407|Superiority||||||<|0.001|||||||Fisher Exact|||TE ADA Positive|
1607860|NCT02614196|2953407|Superiority||||||<|0.001|||||||Fisher Exact|||TE ADA Positive.|
1607861|NCT02614196|2953408|Superiority||LSMean Difference|-8.22|Standard Error of the Mean|1.78|<|0.001|2-Sided|95.0|-11.71|-4.72|||Mixed Models Analysis||||
1607862|NCT02614196|2953408|Superiority||LSMean Difference|-9.15|Standard Error of the Mean|1.76|<|0.001|2-Sided|95.0|-12.61|-5.69|||Mixed Models Analysis||||
1607863|NCT02614196|2953409|Superiority||LSMean Difference|-13.56|Standard Error of the Mean|2.6|<|0.001|2-Sided|95.0|-18.67|-8.44|||Mixed Models Analysis||||
1607864|NCT02614196|2953409|Superiority||LSMean Difference|-15.19|Standard Error of the Mean|2.59|<|0.001|2-Sided|95.0|-20.27|-10.11|||Mixed Models Analysis||||
1607865|NCT02614196|2953410|Superiority||LSMean Difference|-0.23|Standard Error of the Mean|0.09||0.012|2-Sided|95.0|-0.41|-0.05|||Mixed Models Analysis||||
1607870|NCT02614196|2953412|Superiority||LSMean Difference|8.82|Standard Error of the Mean|1.27|<|0.001|2-Sided|95.0|6.33|11.31|||Mixed Models Analysis||||
1607871|NCT02614196|2953413|Superiority||Odds Ratio (OR)|2.67|||||2-Sided|95.0|1.87|3.81||||||Reduction from Baseline ≥100%|
1607872|NCT02614196|2953413|Superiority||Odds Ratio (OR)|2.16|||||2-Sided|95.0|1.5|3.12||||||Reduction from Baseline ≥100%|
1607873|NCT02614196|2953413|Superiority||Odds Ratio (OR)|2.42|||||2-Sided|95.0|1.84|3.17||||||Reduction from Baseline ≥75%|
1607874|NCT02614196|2953413|Superiority||Odds Ratio (OR)|2.34|||||2-Sided|95.0|1.78|3.06||||||Reduction from Baseline ≥75%|
1607875|NCT02614196|2953413|Superiority||Odds Ratio (OR)|2.31|||||2-Sided|95.0|1.81|2.96||||||Reduction from Baseline ≥50%|
1607876|NCT02614196|2953413|Superiority||Odds Ratio (OR)|2.6|||||2-Sided|95.0|2.03|3.32||||||Reduction from Baseline ≥50%|
1607877|NCT02614196|2953414|Superiority||LSMean Difference|-1.9|Standard Error of the Mean|0.27|<|0.001|2-Sided|95.0|-2.44|-1.36|||Mixed Models Analysis||||
1607878|NCT02614196|2953414|Superiority||LSMean Difference|-2.02|Standard Error of the Mean|0.27|<|0.001|2-Sided|95.0|-2.55|-1.48|||Mixed Models Analysis||||
1607879|NCT02614183|2953417|Superiority|||||||0.009|||||||Fisher Exact|||Neutralizing Antibodies.|
1607880|NCT02614183|2953417|Superiority|||||||0.131|||||||Fisher Exact|||Neutralizing Antibodies.|
1607881|NCT02614183|2953417|Superiority|||||||0.02|||||||Fisher Exact|||TE ADA Positive.|
1607882|NCT02614183|2953417|Superiority||||||<|0.16|||||||Fisher Exact|||TE ADA Positive.|
1607883|NCT02614183|2953418|Superiority||Mean Difference (Final Values)|-5.19|Standard Error of the Mean|1.63|<|0.001|2-Sided|95.0|-8.39|-1.98|||Mixed Models Analysis||||
1607884|NCT02614183|2953418|Superiority||Mean Difference (Final Values)|-6.29|Standard Error of the Mean|1.61|<|0.001|2-Sided|95.0|-9.45|-3.13|||Mixed Models Analysis||||
1607885|NCT02614183|2953419|Superiority||Mean Difference (Final Values)|-13.64|Standard Error of the Mean|2.57|<|0.001|2-Sided|95.0|-18.68|-8.6|||Mixed Models Analysis||||
1607886|NCT02614183|2953419|Superiority||Mean Difference (Final Values)|-13.98|Standard Error of the Mean|2.55|<|0.001|2-Sided|95.0|-18.99|-8.97|||Mixed Models Analysis||||
1607887|NCT02614183|2953420|Superiority||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.48|-0.07|||Mixed Models Analysis||||
1607888|NCT02614183|2953420|Superiority||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.52|-0.12|||Mixed Models Analysis||||
1607889|NCT02614183|2953421|Superiority||Odds Ratio (OR)|-1.61|Standard Error of the Mean|0.26|<|0.001|2-Sided|95.0|-2.09|-1.14|||Mixed Models Analysis||||
1607890|NCT02614183|2953421|Superiority||Mean Difference (Final Values)|-1.81|Standard Error of the Mean|0.24|<|0.001|2-Sided|95.0|-2.28|-1.33|||Mixed Models Analysis||||
1607891|NCT02614183|2953422|Superiority||Mean Difference (Final Values)|7.4|Standard Error of the Mean|1.31|<|0.001|2-Sided|95.0|4.83|9.97|||Mixed Models Analysis||||
1607892|NCT02614183|2953422|Superiority||Mean Difference (Final Values)|7.74|Standard Error of the Mean|1.29|<|0.001|2-Sided|95.0|5.2|10.28|||Mixed Models Analysis||||
1607893|NCT02614183|2953423|Superiority||Odds Ratio (OR)|2.61|||||2-Sided|95.0|1.81|3.75||||||Reduction from Baseline = 100%|
1607894|NCT02614183|2953423|Superiority||Odds Ratio (OR)|2.8|||||2-Sided|95.0|1.96|4.01||||||Reduction from Baseline = 100%|
1607895|NCT02614183|2953423|Superiority||Odds Ratio (OR)|2.62|||||2-Sided|95.0|2.01|3.41||||||Reduction from Baseline ≥75%|
1607896|NCT02614183|2953423|Superiority||Odds Ratio (OR)|2.65|||||2-Sided|95.0|2.04|3.45||||||Reduction from Baseline ≥75%|
1607897|NCT02614183|2953423|Superiority||Odds Ratio (OR)|2.48|||||2-Sided|95.0|1.94|3.18||||||Reduction from Baseline ≥50%|
1607898|NCT02614183|2953423|Superiority||Odds Ratio (OR)|2.63|||||2-Sided|95.0|2.05|3.37||||||Reduction from Baseline ≥50%|
1607899|NCT02614183|2953424|Superiority||Mean Difference (Final Values)|-1.76|Standard Error of the Mean|0.28|<|0.001|2-Sided|95.0|-2.31|-1.2|||Mixed Models Analysis||||
1607900|NCT02614183|2953424|Superiority||Mean Difference (Final Values)|-1.92|Standard Error of the Mean|0.28|<|0.001|2-Sided|95.0|-2.48|-1.37|||Mixed Models Analysis||||
1607901|NCT02613507|2953505|Superiority|||||||0.0147|||||||Log Rank|Stratified log-rank|||
1607902|NCT02613507|2953505|Superiority||Hazard Ratio (HR)|0.77|||||2-Sided|95.0|0.62|0.95|||||||
1607903|NCT02613507|2953506|Superiority||Hazard Ratio (HR)|0.76|||||2-Sided|95.0|0.56|1.04|||||Non-squamous subgroup||
1607904|NCT02613507|2953506|Superiority||Hazard Ratio (HR)|0.61|||||2-Sided|95.0|0.42|0.89|||||Squamous subgroup||
1607905|NCT02613507|2953506|Superiority||Hazard Ratio (HR)|0.95|||||2-Sided|95.0|0.37|2.41|||||Subjects with Non-quantifiable PD-L1 Expression||
1607906|NCT02613507|2953506|Superiority||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.52|1.09|||||subjects with less or equal 1% PD-L1 expression||
1607907|NCT02613507|2953506|Superiority||Hazard Ratio (HR)|0.62|||||2-Sided|95.0|0.45|0.87|||||Subjects with greater than or = 1% PD-L1 expression||
1607908|NCT02613507|2953507|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by Histology, PD-L1, and ECOG Performance Status|||
1607909|NCT02613507|2953509|Superiority|||||||0.0017|||||||Log Rank|regular stratified log-rank test p-value|||
1607910|NCT02613507|2953509|Superiority||Hazard Ratio (HR)|0.68|||||2-Sided|97.7|0.52|0.9|||||||
1607911|NCT02613507|2953509|Superiority|||||||0.0006||||||The boundary for statistical significance requires the p-value to be less than 0.0231|Stratified weighted Log-Rank|Stratified weighted using G [rho=0, gamma=1] Fleming and Harrington.|||
1607912|NCT02613208|2953539|Other|Correlation analysis|Spearman coefficient|0.129||||0.241|||||||Spearman's correlation analysis|||Correlation between CTC and CA 15.3 level considering CTC count at cycle 2|
1607913|NCT02613208|2953539|Other|Correlation analysis|Spearman coefficient|0.373|||<|0.001|||||||Spearman's correlation analysis|||Correlation between CTC and CA 15.3 level considering baseline CTC count|
1607914|NCT02613208|2953541|Other|Correlation analysis|Spearman coefficient|0.088||||0.444|||||||Spearman's correlation analysis|||Correlation between CTC and CEA level considering CTC count at cycle 2|
1608163|NCT02610868|2953667|Superiority||||||<|0.0001|||||||ANCOVA||||
1608164|NCT02610868|2953667|Superiority||||||<|0.8115|||||||ANCOVA||||
1607915|NCT02613208|2953541|Other|Correlation analysis|Spearman coefficient|0.392|||<|0.001|||||||Spearman's correlation analysis|||Correlation between CTC and CEA level considering baseline CTC count|
1607916|NCT02612623|2953573|Other||Percentage Change|-74.0|||||2-Sided|95.0|-95.0|34.7|||||100 x [(Exponent of LSM Difference) minus 1]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.|
1607917|NCT02612623|2953573|Other||Percentage Change|-50.8|||||2-Sided|95.0|-90.3|151.1|||||100 x [(Exponent of LSM Difference) minus 1]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.|
1607918|NCT02612623|2953573|Other||Percentage Change|-42.6|||||2-Sided|95.0|-87.5|162.3|||||100 x [(Exponent of LSM Difference) minus 1]|Estimated Percentage Change: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.|
1607919|NCT02612623|2953573|Other||LSM Difference|-1.35|||||2-Sided|95.0|-2.99|0.3|||||Gefapixant minus Placebo|LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.|
1607920|NCT02612623|2953573|Other||LSM Difference|-0.71|||||2-Sided|95.0|-2.34|0.92|||||Gefapixant minus Placebo|LSM difference: MMRM uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.|
1607921|NCT02612623|2953573|Other||LSM Difference|-0.56|||||2-Sided|95.0|-2.08|0.96|||||Gefapixant minus Placebo|Least squares mean (LSM) difference: Mixed effect repeated measures model (MMRM) uses the change from baseline as the dependent variable, and includes the treatment group, visit day, and the interaction between treatment and visit as fixed factors, and baseline as a covariate.|
1607922|NCT02612610|2953574|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of “No Taste Effect Noted” or “Not at All” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607923|NCT02612610|2953574|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of “No Taste Effect Noted” or “Not at All” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607924|NCT02612610|2953574|Superiority or Other||||||<|0||||||A p-value of zero was calculated if all participants (100%) had “No Taste Effect Noted” or “Not at All” responses in both comparison groups.|Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of “No Taste Effect Noted” or “Not at All” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607925|NCT02612610|2953575|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 50 mg gefapixant vs. placebo~The distribution of “No Taste Effect Noted” or “Never” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607926|NCT02612610|2953575|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 20 mg gefapixant vs. placebo~The distribution of “No Taste Effect Noted” or “Never” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607927|NCT02612610|2953575|Superiority or Other||||||<|0.6115|||||||Cochran-Mantel-Haenszel|||"Taste Effect Frequency: 7.5 mg gefapixant vs. placebo~The distribution of “No Taste Effect Noted” or “Never” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607928|NCT02612610|2953576|Superiority or Other|||||||0.0534|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 50 mg gefapixant vs. placebo~The distribution of “Extremely likely” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607929|NCT02612610|2953576|Superiority or Other|||||||0.2333|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 20 mg gefapixant vs. placebo~The distribution of “Extremely likely” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607930|NCT02612610|2953576|Superiority or Other|||||||0.3887|||||||Cochran-Mantel-Haenszel|||"Twice Daily Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of “Extremely likely” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607931|NCT02612610|2953577|Superiority or Other|||||||0.279|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 50 mg gefapixant vs. placebo~The distribution of “Extremely likely” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607932|NCT02612610|2953577|Superiority or Other|||||||0.5091|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 20 mg gefapixant vs. placebo~The distribution of “Extremely likely” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607933|NCT02612610|2953577|Superiority or Other|||||||0.7559|||||||Cochran-Mantel-Haenszel|||"4 Week Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of “Extremely likely” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1608165|NCT02610868|2953667|Superiority||||||<|0.0001|||||||ANCOVA||||
1607934|NCT02612610|2953578|Superiority or Other|||||||0.2155|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 50 mg gefapixant vs. placebo~The distribution of “Extremely likely” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607935|NCT02612610|2953578|Superiority or Other|||||||0.6372|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 20 mg gefapixant vs. placebo~The distribution of “Extremely likely” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607936|NCT02612610|2953578|Superiority or Other|||||||0.9966|||||||Cochran-Mantel-Haenszel|||"6 Month Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of “Extremely likely” responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607937|NCT02612610|2953579|Superiority or Other|||||||0.4364|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 50 mg gefapixant vs. placebo~The distribution of “Extremely likely” responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607938|NCT02612610|2953579|Superiority or Other|||||||0.7687|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 20 mg gefapixant vs. placebo~The distribution of “Extremely likely” responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for gefapixant vs. placebo using CMH test."|
1607939|NCT02612610|2953579|Superiority or Other|||||||0.8464|||||||Cochran-Mantel-Haenszel|||"1 Year Acceptability: 7.5 mg gefapixant vs. placebo~The distribution of “Extremely likely” responses was compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated for the gefapixant vs. placebo using CMH test."|
1607940|NCT02612610|2953580|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."|
1607941|NCT02612610|2953580|Superiority or Other|||||||0.0751|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."|
1607942|NCT02612610|2953580|Superiority or Other|||||||0.0396|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination CGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."|
1607943|NCT02612610|2953581|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."|
1607944|NCT02612610|2953581|Superiority or Other||||||<|0.0166|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."|
1607945|NCT02612610|2953581|Superiority or Other||||||<|0.0037|||||||Cochran-Mantel-Haenszel|||"Day 85/Early Termination PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."|
1607946|NCT02612610|2953582|Superiority or Other|||||||0.0009|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."|
1607947|NCT02612610|2953582|Superiority or Other|||||||0.0994|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."|
1607948|NCT02612610|2953582|Superiority or Other|||||||0.0872|||||||Cochran-Mantel-Haenszel|||"Day 56 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."|
1607949|NCT02612610|2953583|Superiority or Other|||||||0.0665|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 50 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."|
1607950|NCT02612610|2953583|Superiority or Other|||||||0.5021|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 20 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."|
1607951|NCT02612610|2953583|Superiority or Other|||||||0.3182|||||||Cochran-Mantel-Haenszel|||"Day 28 PGIC: 7.5 mg gefapixant vs. placebo~The distribution of responses were compared between each of the gefapixant treatment groups and placebo using the stratified CMH test (stratified by country). P-values calculated using CMH test."|
1607952|NCT02612610|2953584|Other||LS Mean Difference|1.9||||0.0028|2-Sided|95.0|0.7|3.1|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607953|NCT02612610|2953584|Other||LS Mean Difference|1.0||||0.0967|2-Sided|95.0|-0.2|2.3|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 20 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607954|NCT02612610|2953584|Other||LS Mean Difference|1.2||||0.0626|2-Sided|95.0|-0.1|2.4|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607955|NCT02612610|2953585|Other||LS Mean Difference|1.5||||0.0192|2-Sided|95.0|0.2|2.7|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607956|NCT02612610|2953585|Other||LS Mean Difference|0.9||||0.1321|2-Sided|95.0|-0.3|2.2|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607957|NCT02612610|2953585|Other||LS Mean Difference|1.0||||0.0941|2-Sided|95.0|-0.2|2.3|||Mixed Effect Repeated Measures model|||"Day 56 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607958|NCT02612610|2953586|Other||LS Mean Difference|2.1||||0.0004|2-Sided|95.0|0.9|3.2|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607959|NCT02612610|2953586|Other||LS Mean Difference|0.2||||0.7601|2-Sided|95.0|-1.0|1.3|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607960|NCT02612610|2953586|Other||LS Mean Difference|0.8||||0.163|2-Sided|95.0|-0.3|1.9|||Mixed Effect Repeated Measures model|||"Day 28 LCQ Total Score: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607961|NCT02612610|2953587|Other||LS Mean Difference|-0.6||||0.0961|2-Sided|95.0|-1.4|0.1|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607962|NCT02612610|2953587|Other||LS Mean Difference|-0.6||||0.0882|2-Sided|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607963|NCT02612610|2953587|Other||LS Mean Difference|-0.3||||0.4163|2-Sided|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 12 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607964|NCT02612610|2953588|Other||LS Mean Difference|-0.7||||0.0575|2-Sided|95.0|-1.4|0.0|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607965|NCT02612610|2953588|Other||LS Mean Difference|-0.6||||0.0828|2-Sided|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607966|NCT02612610|2953588|Other||LS Mean Difference|-0.3||||0.4058|2-Sided|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 11 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607967|NCT02612610|2953589|Other||LS Mean Difference|-0.5||||0.1263|2-Sided|95.0|-1.2|0.2|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607968|NCT02612610|2953589|Other||LS Mean Difference|-0.6||||0.0918|2-Sided|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607969|NCT02612610|2953589|Other||LS Mean Difference|-0.1||||0.7255|2-Sided|95.0|-0.8|0.6|||Mixed Effect Repeated Measures model|||"Week 10 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608166|NCT02610868|2953667|Superiority||||||<|0.4567|||||||ANCOVA||||
1608167|NCT02610868|2953667|Superiority||||||<|0.0001|||||||ANCOVA||||
1608168|NCT02610868|2953667|Superiority||||||<|0.0001|||||||ANCOVA||||
1607970|NCT02612610|2953590|Other||LS Mean Difference|-0.4||||0.2672|2-Sided|95.0|-1.1|0.3|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607971|NCT02612610|2953590|Other||LS Mean Difference|-0.6||||0.0854|2-Sided|95.0|-1.3|0.1|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607972|NCT02612610|2953590|Other||LS Mean Difference|-0.3||||0.3749|2-Sided|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 9 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607973|NCT02612610|2953591|Other||LS Mean Difference|-0.3||||0.4629|2-Sided|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607974|NCT02612610|2953591|Other||LS Mean Difference|-0.3||||0.4456|2-Sided|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607975|NCT02612610|2953591|Other||LS Mean Difference|-0.2||||0.6022|2-Sided|95.0|-0.9|0.5|||Mixed Effect Repeated Measures model|||"Week 8 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607976|NCT02612610|2953592|Other||LS Mean Difference|-0.4||||0.2809|2-Sided|95.0|-1.1|0.3|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607977|NCT02612610|2953592|Other||LS Mean Difference|-0.3||||0.3514|2-Sided|95.0|-1.0|0.4|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607978|NCT02612610|2953592|Other||LS Mean Difference|-0.1||||0.6715|2-Sided|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 7 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607979|NCT02612610|2953593|Other||LS Mean Difference|-0.6||||0.0848|2-Sided|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607980|NCT02612610|2953593|Other||LS Mean Difference|-0.6||||0.0651|2-Sided|95.0|-1.3|0.0|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607981|NCT02612610|2953593|Other||LS Mean Difference|-0.5||||0.1718|2-Sided|95.0|-1.1|0.2|||Mixed Effect Repeated Measures model|||"Week 6 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607982|NCT02612610|2953594|Other||LS Mean Difference|-0.7||||0.0352|2-Sided|95.0|-1.4|0.0|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607983|NCT02612610|2953594|Other||LS Mean Difference|-0.5||||0.1136|2-Sided|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607984|NCT02612610|2953594|Other||LS Mean Difference|0.0||||0.9126|2-Sided|95.0|-0.7|0.6|||Mixed Effect Repeated Measures model|||"Week 5 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607985|NCT02612610|2953595|Other||LS Mean Difference|-0.3||||0.3031|2-Sided|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608169|NCT02610868|2953667|Superiority||||||<|0.0001|||||||ANCOVA||||
1608170|NCT02610868|2953667|Superiority||||||<|0.0001|||||||ANCOVA||||
1608171|NCT02610868|2953668|Superiority|||||||0.4992|||||||ANCOVA||||
1608172|NCT02610868|2953668|Superiority|||||||0.0753|||||||ANCOVA||||
1607986|NCT02612610|2953595|Other||LS Mean Difference|-0.3||||0.4044|2-Sided|95.0|-0.9|0.4|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607987|NCT02612610|2953595|Other||LS Mean Difference|-0.1||||0.8457|2-Sided|95.0|-0.7|0.6|||Mixed Effect Repeated Measures model|||"Week 4 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607988|NCT02612610|2953596|Other||LS Mean Difference|-0.3||||0.422|2-Sided|95.0|-0.9|0.4|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607989|NCT02612610|2953596|Other||LS Mean Difference|-0.2||||0.6108|2-Sided|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607990|NCT02612610|2953596|Other||LS Mean Difference|0.1||||0.8084|2-Sided|95.0|-0.6|0.8|||Mixed Effect Repeated Measures model|||"Week 3 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607991|NCT02612610|2953597|Other||LS Mean Difference|-0.3||||0.2837|2-Sided|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607992|NCT02612610|2953597|Other||LS Mean Difference|0.2||||0.4599|2-Sided|95.0|-0.4|0.9|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607993|NCT02612610|2953597|Other||LS Mean Difference|0.3||||0.4033|2-Sided|95.0|-0.4|0.9|||Mixed Effect Repeated Measures model|||"Week 2 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607994|NCT02612610|2953598|Other||LS Mean Difference|-0.1||||0.7383|2-Sided|95.0|-0.6|0.4|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607995|NCT02612610|2953598|Other||LS Mean Difference|0.3||||0.2428|2-Sided|95.0|-0.2|0.8|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607996|NCT02612610|2953598|Other||LS Mean Difference|0.3||||0.1921|2-Sided|95.0|-0.2|0.8|||Mixed Effect Repeated Measures model|||"Week 1 DCS Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607997|NCT02612610|2953599|Other||LS Mean Difference|-0.7||||0.0197|2-Sided|95.0|-1.4|-0.1|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 50 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607998|NCT02612610|2953599|Other||LS Mean Difference|-0.6||||0.0662|2-Sided|95.0|-1.2|0.0|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 20 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1607999|NCT02612610|2953599|Other||LS Mean Difference|-0.4||||0.2458|2-Sided|95.0|-1.0|0.3|||Mixed Effect Repeated Measures model|||"Week 12 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 12 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608000|NCT02612610|2953600|Other||LS Mean Difference|-0.8||||0.0155|2-Sided|95.0|-1.4|-0.1|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 50 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608001|NCT02612610|2953600|Other||LS Mean Difference|-0.6||||0.0665|2-Sided|95.0|-1.2|0.0|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 20 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608173|NCT02610868|2953668|Superiority|||||||0.9016|||||||ANCOVA||||
1608174|NCT02610868|2953668|Superiority|||||||0.0003|||||||ANCOVA||||
1608175|NCT02610868|2953668|Superiority||||||<|0.0001|||||||ANCOVA||||
1608176|NCT02610868|2953668|Superiority||||||<|0.0001|||||||ANCOVA||||
1608002|NCT02612610|2953600|Other||LS Mean Difference|-0.4||||0.2058|2-Sided|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 11 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 11 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608003|NCT02612610|2953601|Other||LS Mean Difference|-0.7||||0.0313|2-Sided|95.0|-1.3|-0.1|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 50 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608004|NCT02612610|2953601|Other||LS Mean Difference|-0.4||||0.1769|2-Sided|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 20 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608005|NCT02612610|2953601|Other||LS Mean Difference|-0.1||||0.6266|2-Sided|95.0|-0.8|0.5|||Mixed Effect Repeated Measures model|||"Week 10 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 10 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608006|NCT02612610|2953602|Other||LS Mean Difference|-0.6||||0.0737|2-Sided|95.0|-1.2|0.1|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 50 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608007|NCT02612610|2953602|Other||LS Mean Difference|-0.5||||0.1132|2-Sided|95.0|-1.1|0.1|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 20 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608008|NCT02612610|2953602|Other||LS Mean Difference|-0.3||||0.2772|2-Sided|95.0|-0.9|0.3|||Mixed Effect Repeated Measures model|||"Week 9 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 9 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608009|NCT02612610|2953603|Other||LS Mean Difference|-0.4||||0.1907|2-Sided|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 50 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608010|NCT02612610|2953603|Other||LS Mean Difference|-0.2||||0.4371|2-Sided|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 20 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608011|NCT02612610|2953603|Other||LS Mean Difference|-0.2||||0.4716|2-Sided|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 8 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 8 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608012|NCT02612610|2953604|Other||LS Mean Difference|-0.5||||0.0792|2-Sided|95.0|-1.1|0.1|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 50 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608013|NCT02612610|2953604|Other||LS Mean Difference|-0.3||||0.332|2-Sided|95.0|-0.9|0.3|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 20 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608014|NCT02612610|2953604|Other||LS Mean Difference|-0.2||||0.4464|2-Sided|95.0|-0.8|0.4|||Mixed Effect Repeated Measures model|||"Week 7 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 7 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608015|NCT02612610|2953605|Other||LS Mean Difference|-0.7||||0.0274|2-Sided|95.0|-1.2|-0.1|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 50 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608016|NCT02612610|2953605|Other||LS Mean Difference|-0.5||||0.071|2-Sided|95.0|-1.1|0.0|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 20 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608017|NCT02612610|2953605|Other||LS Mean Difference|-0.4||||0.1562|2-Sided|95.0|-1.0|0.2|||Mixed Effect Repeated Measures model|||"Week 6 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 6 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608177|NCT02610868|2953668|Superiority||||||<|0.0001|||||||ANCOVA||||
1608178|NCT02610868|2953668|Superiority||||||<|0.0001|||||||ANCOVA||||
1608179|NCT02610868|2953668|Superiority||||||<|0.0001|||||||ANCOVA||||
1608180|NCT02610868|2953669|Superiority|||||||0.029|||||||ANCOVA||||
1608018|NCT02612610|2953606|Other||LS Mean Difference|-0.7||||0.0221|2-Sided|95.0|-1.2|-0.1|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 50 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608019|NCT02612610|2953606|Other||LS Mean Difference|-0.4||||0.143|2-Sided|95.0|-1.0|0.1|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 20 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608020|NCT02612610|2953606|Other||LS Mean Difference|-0.2||||0.5796|2-Sided|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 5 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 5 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608021|NCT02612610|2953607|Other||LS Mean Difference|-0.5||||0.1046|2-Sided|95.0|-1.0|0.1|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 50 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608022|NCT02612610|2953607|Other||LS Mean Difference|-0.3||||0.3129|2-Sided|95.0|-0.8|0.3|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 20 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608023|NCT02612610|2953607|Other||LS Mean Difference|-0.2||||0.5358|2-Sided|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 4 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 4 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608024|NCT02612610|2953608|Other||LS Mean Difference|-0.5||||0.0612|2-Sided|95.0|-1.1|0.0|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 50 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608025|NCT02612610|2953608|Other||LS Mean Difference|-0.3||||0.2499|2-Sided|95.0|-0.9|0.2|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 20 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608026|NCT02612610|2953608|Other||LS Mean Difference|-0.2||||0.5797|2-Sided|95.0|-0.7|0.4|||Mixed Effect Repeated Measures model|||"Week 3 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 3 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608027|NCT02612610|2953609|Other||LS Mean Difference|-0.4||||0.0951|2-Sided|95.0|-0.9|0.1|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 50 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608028|NCT02612610|2953609|Other||LS Mean Difference|0.1||||0.7635|2-Sided|95.0|-0.4|0.6|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 20 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608029|NCT02612610|2953609|Other||LS Mean Difference|0.1||||0.7328|2-Sided|95.0|-0.4|0.6|||Mixed Effect Repeated Measures model|||"Week 2 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 2 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608030|NCT02612610|2953610|Other||LS Mean Difference|0.0||||0.9962|2-Sided|95.0|-0.4|0.4|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 50 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608031|NCT02612610|2953610|Other||LS Mean Difference|0.3||||0.2013|2-Sided|95.0|-0.1|0.7|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 20 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608032|NCT02612610|2953610|Other||LS Mean Difference|0.3||||0.1545|2-Sided|95.0|-0.1|0.7|||Mixed Effect Repeated Measures model|||"Week 1 CSD Total Score: 7.5 mg gefapixant vs. placebo~Week 1 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608033|NCT02612610|2953611|Other||LS Mean Difference|0.28||||0.3167|2-Sided|95.0|-0.27|0.83|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608181|NCT02610868|2953669|Superiority||||||<|0.0001|||||||ANCOVA||||
1608182|NCT02610868|2953669|Superiority||||||<|1|||||||ANCOVA||||
1608183|NCT02610868|2953669|Superiority||||||<|0.0001|||||||ANCOVA||||
1608184|NCT02610868|2953669|Superiority||||||<|0.11|||||||ANCOVA||||
1608034|NCT02612610|2953611|Other||LS Mean Difference|0.08||||0.7782|2-Sided|95.0|-0.46|0.61|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608035|NCT02612610|2953611|Other||LS Mean Difference|0.14||||0.6102|2-Sided|95.0|-0.4|0.68|||Mixed Effect Repeated Measures model|||"Day 84 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608036|NCT02612610|2953612|Other||LS Mean Difference|-0.4||||0.1672|2-Sided|95.0|-0.98|0.17|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608037|NCT02612610|2953612|Other||LS Mean Difference|0.01||||0.9826|2-Sided|95.0|-0.55|0.56|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608038|NCT02612610|2953612|Other||LS Mean Difference|-0.32||||0.2583|2-Sided|95.0|-0.88|0.24|||Mixed Effect Repeated Measures model|||"Day 56 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608039|NCT02612610|2953613|Other||LS Mean Difference|-0.11||||0.6746|2-Sided|95.0|-0.65|0.42|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608040|NCT02612610|2953613|Other||LS Mean Difference|-0.01||||0.9813|2-Sided|95.0|-0.53|0.52|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608041|NCT02612610|2953613|Other||LS Mean Difference|0.0||||0.9858|2-Sided|95.0|-0.53|0.54|||Mixed Effect Repeated Measures model|||"Day 28 Sleep Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608042|NCT02612610|2953614|Superiority or Other|||||||0.3258|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608043|NCT02612610|2953614|Superiority or Other|||||||0.9706|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608044|NCT02612610|2953614|Superiority or Other|||||||0.4575|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608045|NCT02612610|2953614|Superiority or Other|||||||0.0993|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608046|NCT02612610|2953614|Superiority or Other|||||||0.9763|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608047|NCT02612610|2953614|Superiority or Other|||||||0.2721|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608048|NCT02612610|2953614|Superiority or Other|||||||0.1602|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608185|NCT02610868|2953669|Superiority||||||<|0.0001|||||||ANCOVA||||
1608049|NCT02612610|2953614|Superiority or Other|||||||0.5055|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608050|NCT02612610|2953614|Superiority or Other|||||||0.2441|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608051|NCT02612610|2953615|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608052|NCT02612610|2953615|Superiority or Other|||||||0.3856|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608053|NCT02612610|2953615|Superiority or Other|||||||0.0285|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608054|NCT02612610|2953615|Superiority or Other|||||||0.0008|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608055|NCT02612610|2953615|Superiority or Other|||||||0.3301|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608056|NCT02612610|2953615|Superiority or Other|||||||0.0192|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608057|NCT02612610|2953615|Superiority or Other|||||||0.0236|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608058|NCT02612610|2953615|Superiority or Other|||||||0.1177|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608059|NCT02612610|2953615|Superiority or Other|||||||0.3845|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608060|NCT02612610|2953616|Superiority or Other|||||||0.0006|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608061|NCT02612610|2953616|Superiority or Other|||||||0.3577|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608062|NCT02612610|2953616|Superiority or Other|||||||0.0722|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608186|NCT02610868|2953669|Superiority||||||<|0.0001|||||||ANCOVA||||
1608063|NCT02612610|2953616|Superiority or Other|||||||0.0085|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608064|NCT02612610|2953616|Superiority or Other|||||||0.6255|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608065|NCT02612610|2953616|Superiority or Other|||||||0.0165|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608066|NCT02612610|2953616|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608067|NCT02612610|2953616|Superiority or Other|||||||0.0223|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608068|NCT02612610|2953616|Superiority or Other|||||||0.0006|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608069|NCT02612610|2953617|Superiority or Other|||||||0.0822|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608070|NCT02612610|2953617|Superiority or Other|||||||0.5384|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608071|NCT02612610|2953617|Superiority or Other|||||||0.4343|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608072|NCT02612610|2953617|Superiority or Other|||||||0.0013|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608073|NCT02612610|2953617|Superiority or Other|||||||0.267|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608074|NCT02612610|2953617|Superiority or Other|||||||0.1284|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608075|NCT02612610|2953617|Superiority or Other|||||||0.0068|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608076|NCT02612610|2953617|Superiority or Other|||||||0.7098|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608187|NCT02610868|2953669|Superiority||||||<|0.0001|||||||ANCOVA||||
1608188|NCT02610868|2953669|Superiority||||||<|0.0001|||||||ANCOVA||||
1608077|NCT02612610|2953617|Superiority or Other|||||||0.0781|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608078|NCT02612610|2953618|Superiority or Other|||||||0.4092|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608079|NCT02612610|2953618|Superiority or Other|||||||0.8726|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608080|NCT02612610|2953618|Superiority or Other|||||||0.5968|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608081|NCT02612610|2953618|Superiority or Other|||||||0.0993|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608082|NCT02612610|2953618|Superiority or Other|||||||0.9876|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608083|NCT02612610|2953618|Superiority or Other|||||||0.344|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608084|NCT02612610|2953618|Superiority or Other|||||||0.1602|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608085|NCT02612610|2953618|Superiority or Other|||||||0.9007|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608086|NCT02612610|2953618|Superiority or Other|||||||0.4925|||||||Cochran-Mantel-Haenszel|||"Day 98: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608087|NCT02612610|2953619|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608088|NCT02612610|2953619|Superiority or Other|||||||0.6233|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608089|NCT02612610|2953619|Superiority or Other|||||||0.0283|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608090|NCT02612610|2953619|Superiority or Other|||||||0.0031|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608189|NCT02610868|2953671|Superiority|||||||0.1663|||||||ANCOVA||||
1608091|NCT02612610|2953619|Superiority or Other|||||||0.3401|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608092|NCT02612610|2953619|Superiority or Other|||||||0.0209|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608093|NCT02612610|2953619|Superiority or Other|||||||0.0427|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608094|NCT02612610|2953619|Superiority or Other|||||||0.2803|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608095|NCT02612610|2953619|Superiority or Other|||||||0.3893|||||||Cochran-Mantel-Haenszel|||"Day 84: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608096|NCT02612610|2953620|Superiority or Other|||||||0.0086|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608097|NCT02612610|2953620|Superiority or Other|||||||0.3601|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608098|NCT02612610|2953620|Superiority or Other|||||||0.0652|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608099|NCT02612610|2953620|Superiority or Other|||||||0.0026|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608100|NCT02612610|2953620|Superiority or Other|||||||0.1493|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608101|NCT02612610|2953620|Superiority or Other|||||||0.0283|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608102|NCT02612610|2953620|Superiority or Other|||||||0.008|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608103|NCT02612610|2953620|Superiority or Other|||||||0.0947|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608104|NCT02612610|2953620|Superiority or Other|||||||0.0045|||||||Cochran-Mantel-Haenszel|||"Day 56: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608190|NCT02610868|2953671|Superiority|||||||0.0002|||||||ANCOVA||||
1608105|NCT02612610|2953621|Superiority or Other|||||||0.1511|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608106|NCT02612610|2953621|Superiority or Other|||||||0.6443|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608107|NCT02612610|2953621|Superiority or Other|||||||0.0653|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥30% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608108|NCT02612610|2953621|Superiority or Other|||||||0.0088|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608109|NCT02612610|2953621|Superiority or Other|||||||0.3812|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608110|NCT02612610|2953621|Superiority or Other|||||||0.0922|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥50% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608111|NCT02612610|2953621|Superiority or Other|||||||0.0144|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 50 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608112|NCT02612610|2953621|Superiority or Other|||||||0.7238|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 20 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a GLMM with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified CMH test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608113|NCT02612610|2953621|Superiority or Other|||||||0.1387|||||||Cochran-Mantel-Haenszel|||"Day 28: ≥70% Change: 7.5 mg gefapixant vs. placebo~Cough frequency responder endpoints were analyzed by a generalized linear mixed model (GLMM) with treatment, visit, and treatment by visit interaction, and country as fixed effects. Comparison of response rates between each gefapixant treatment group and placebo was conducted using the stratified Cochran Mantel Haenszel (CMH) test (stratified by country, unless stated otherwise). Missing data was categorized as discontinued or missing."|
1608114|NCT02612610|2953622|Other||LS Mean Difference|-15.9||||0.0003|2-Sided|95.0|-24.3|-7.5|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608115|NCT02612610|2953622|Other||LS Mean Difference|-8.2||||0.0519|2-Sided|95.0|-16.6|0.1|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608116|NCT02612610|2953622|Other||LS Mean Difference|-4.0||||0.3509|2-Sided|95.0|-12.3|4.4|||Mixed Effect Repeated Measures model|||"Day 85/Early Termination Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 85/Early Termination estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608117|NCT02612610|2953623|Other||LS Mean Difference|-11.2||||0.0108|2-Sided|95.0|-19.7|-2.6|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608118|NCT02612610|2953623|Other||LS Mean Difference|-6.4||||0.1365|2-Sided|95.0|-14.8|2.0|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608191|NCT02610868|2953671|Superiority|||||||0.1054|||||||ANCOVA||||
1608192|NCT02610868|2953671|Superiority||||||<|0.0001|||||||ANCOVA||||
1608193|NCT02610868|2953671|Superiority||||||<|0.313|||||||ANCOVA||||
1608194|NCT02610868|2953671|Superiority||||||<|0.0001|||||||ANCOVA||||
1608119|NCT02612610|2953623|Other||LS Mean Difference|-4.4||||0.302|2-Sided|95.0|-12.9|4.0|||Mixed Effect Repeated Measures model|||"Day 84 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608120|NCT02612610|2953624|Other||LS Mean Difference|-10.7||||0.0197|2-Sided|95.0|-19.8|-1.7|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608121|NCT02612610|2953624|Other||LS Mean Difference|-3.2||||0.4702|2-Sided|95.0|-12.0|5.6|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608122|NCT02612610|2953624|Other||LS Mean Difference|-2.6||||0.554|2-Sided|95.0|-11.5|6.2|||Mixed Effect Repeated Measures model|||"Day 56 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608123|NCT02612610|2953625|Other||LS Mean Difference|-9.8||||0.0228|2-Sided|95.0|-18.2|-1.4|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608124|NCT02612610|2953625|Other||LS Mean Difference|-2.9||||0.4917|2-Sided|95.0|-11.3|5.4|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608125|NCT02612610|2953625|Other||LS Mean Difference|-6.4||||0.1318|2-Sided|95.0|-14.8|1.9|||Mixed Effect Repeated Measures model|||"Day 28 Cough Severity VAS: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value as a covariate."|
1608126|NCT02612610|2953627|Other||LS Mean Difference|-0.59||||0.0004|2-Sided|95.0|-0.92|-0.27|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608127|NCT02612610|2953627|Other||LS Mean Difference|-0.32||||0.0498|2-Sided|95.0|-0.63|0.0|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608128|NCT02612610|2953627|Other||Mixed Effect Repeated Measures model|-0.39||||0.0177|2-Sided|95.0|-0.7|-0.07|||Mixed Effect Repeated Measures model|||"Day 56 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608129|NCT02612610|2953628|Other||LS Mean Difference|-0.49||||0.0008|2-Sided|95.0|-0.78|-0.21|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608130|NCT02612610|2953628|Other||LS Mean Difference|-0.08||||0.5874|2-Sided|95.0|-0.36|0.2|||Mixed Effect Repeated Measures model|||"Day 28 Awake Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608131|NCT02612610|2953628|Other||LS Mean Difference|-0.21||||0.1468|2-Sided|95.0|-0.5|0.07|||Mixed Effect Repeated Measures model|||"Day 28 Awake Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate. ."|
1608132|NCT02612610|2953629|Other||LS Mean Difference|-0.47||||0.0014|2-Sided|95.0|-0.76|-0.19|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608133|NCT02612610|2953629|Other||LS Mean Difference|-0.25||||0.0811|2-Sided|95.0|-0.53|0.03|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608134|NCT02612610|2953629|Other||LS Mean Difference|-0.24||||0.0991|2-Sided|95.0|-0.52|0.04|||Mixed Effect Repeated Measures model|||"Day 84 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 84 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608195|NCT02610868|2953671|Superiority||||||<|0.0001|||||||ANCOVA||||
1608135|NCT02612610|2953630|Other||LS Mean Difference|-0.62||||0.0001|2-Sided|95.0|-0.93|-0.31|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608136|NCT02612610|2953630|Other||LS Mean Difference|-0.28||||0.0695|2-Sided|95.0|-0.58|0.02|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608137|NCT02612610|2953630|Other||LS Mean Difference|-0.4||||0.0099|2-Sided|95.0|-0.71|-0.1|||Mixed Effect Repeated Measures model|||"Day 56 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 56 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608138|NCT02612610|2953631|Other||LS Mean Difference|-0.52||||0.0003|2-Sided|95.0|-0.8|-0.24|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 50 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608139|NCT02612610|2953631|Other||LS Mean Difference|-0.05||||0.7099|2-Sided|95.0|-0.33|0.23|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 20 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608140|NCT02612610|2953631|Other||LS Mean Difference|-0.19||||0.1914|2-Sided|95.0|-0.47|0.09|||Mixed Effect Repeated Measures model|||"Day 28 24-hour Cough Frequency: 7.5 mg gefapixant vs. placebo~Day 28 estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate."|
1608141|NCT02612610|2953632|Other||LS Mean Difference|-0.46||||0.0027|2-Sided|95.0|-0.76|-0.16|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.|
1608142|NCT02612610|2953632|Other||LS Mean Difference|-0.25||||0.0928|2-Sided|95.0|-0.54|0.04|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% CIs were estimated using a MMRM model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.|
1608143|NCT02612610|2953632|Other||LS Mean Difference|-0.25||||0.0971|2-Sided|95.0|-0.54|0.05|||Mixed Effect Repeated Measures model|||Estimated treatment differences (gefapixant vs. placebo) and corresponding 95% confidence intervals (CIs) were estimated using a mixed effect repeated measures (MMRM) model, which included fixed effects for treatment group, visit, country, treatment-by-visit interaction, and Baseline value (on log scale) as a covariate.|
1608144|NCT02612428|2953633|Superiority|||||||0.048|||||||Chi-squared||||
1608145|NCT02612428|2953634|Superiority|||||||0.6829|||||||Chi-squared||||
1608146|NCT02612428|2953635|Superiority||Hazard Ratio (HR)|0.913||||0.762|2-Sided|95.0|0.509|1.64|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-treat (ITT) population utilizing a log-rank test.|
1608147|NCT02612064|2953642|Superiority or Other||Least Square (LS) mean difference|-0.18||||0.1575|2-Sided|95.0|-0.442|0.072|||ANCOVA|Change from baseline in Schiff Sensitivity Score as response, treatment as a factor and baseline Schiff sensitivity as a covariate.|Difference is first named dentifrice minus second named dentifrice such that a negative difference favours first named dentifrice.|All statistical analyses were conducted under the null hypothesis (H0) of no difference between treatments versus the alternate hypothesis (H1) of a difference between treatments.|
1608148|NCT02611830|2953643|Superiority||Risk Difference (RD)|20.6||||0.067|2-Sided|95.0|-4.5|43.7||P-value was calculated by Fisher’s Exact Test.|Fisher Exact||||
1608149|NCT02611830|2953644|Superiority||Risk Difference (RD)|9.7||||0.076|2-Sided|95.0|-6.6|25.7||P-value was calculated by Fisher’s Exact Test.|Fisher Exact||||
1608150|NCT02611830|2953645|Superiority||Risk Difference (RD)|36.1|||<|0.001|2-Sided|95.0|21.2|50.9||P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel||||
1608151|NCT02611830|2953646|Superiority||Risk Difference (RD)|35.7|||<|0.001|2-Sided|95.0|22.1|49.3||P-value was calculated by CMH test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel||||
1608152|NCT02611830|2953647|Superiority||Risk Difference (RD)|32.3|||<|0.001|2-Sided|95.0|19.7|45.0||P-value was calculated by Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata according to concomitant use of corticosteroids, clinical remission status at Week 6, and previous TNF-α antagonist failure/concomitant immunomodulator.|Cochran-Mantel-Haenszel||||
1608153|NCT02610868|2953665|Superiority|||||||0.3825|||||||ANCOVA||||
1608154|NCT02610868|2953665|Superiority||||||<|0.0001|||||||ANCOVA||||
1608155|NCT02610868|2953665|Superiority||||||<|0.7787|||||||ANCOVA||||
1608156|NCT02610868|2953665|Superiority||||||<|0.0001|||||||ANCOVA||||
1608157|NCT02610868|2953665|Superiority||||||<|0.3786|||||||ANCOVA||||
1608158|NCT02610868|2953665|Superiority||||||<|0.0001|||||||ANCOVA||||
1608159|NCT02610868|2953665|Superiority||||||<|0.0001|||||||ANCOVA||||
1608160|NCT02610868|2953665|Superiority||||||<|0.0001|||||||ANCOVA||||
1608161|NCT02610868|2953665|Superiority||||||<|0.0001|||||||ANCOVA||||
1608162|NCT02610868|2953667|Superiority|||||||0.3282|||||||ANCOVA||||
1608208|NCT02610816|2953683|Superiority|||||||0.74|||||||Mixed Models Analysis||||
1608209|NCT02610816|2953684|Superiority|||||||0.93|||||||Mixed Models Analysis||||
1608210|NCT02610816|2953687|Superiority|||||||1|||||||Fisher Exact||||
1608211|NCT02610816|2953688|Superiority||||||<|0.0001||||||This is a calculated p-value. The threshold for statistical significance is p <0.05|Mixed Models Analysis||||
1608212|NCT02610816|2953688|Superiority||||||<|0.0001||||||This is a calculated p-value. The threshold for statistical significance is p <0.05.|Mixed Models Analysis||||
1608213|NCT02610816|2953689|Superiority|||||||0.04||||||P-values are not adjusted for multiplicity, since a single primary endpoint is analyzed|Mixed Models Analysis|No adjustment of degrees of freedom is needed.||The primary treatment comparison was to compare change in PEESS V2.0 scores of 1FED versus 4FED. The primary null hypothesis was 4FED would be no more effective than 1FED. This was designed as a superiority trial.|
1608214|NCT02610725|2953692|Superiority||Mean Difference (Final Values)|6.06|Standard Error of the Mean|0.98|<|0.001|2-Sided|95.0|4.1|8.02|||t-test, 2 sided|51 degrees of freedom|Means were analyzed in a (pre-post) format. A positive mean indicates a decrease in negative affect.|Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes negative affect analysis.|
1608215|NCT02610725|2953692|Superiority||Mean Difference (Final Values)|-2.1|Standard Deviation|0.81|<|0.013|2-Sided|95.0|-3.73|-0.46|||t-test, 2 sided|51 degrees of freedom.|Means were analyzed in (pre-post) format. A negative mean here indicates an increase in positive affect.|Paired-samples t-tests were used to analyze change in affect after participating in the yoga class. Analyses were conducted to measure changes in both positive affect and negative affect. This entry describes positive affect analysis.|
1608216|NCT02609984|2953733|Other|||||||0.0127|||||||exact Pearson chi-square test||||
1608217|NCT02609984|2953734|Other|||||||0.405|||||||exact Pearson chi-square test||||
1608218|NCT02609984|2953735|Other||||||<|0.0001|||||||exact Pearson chi-square test||||
1608219|NCT02609984|2953736|Other|||||||0.1128|||||||exact Pearson chi-square test||||
1608220|NCT02609984|2953737|Other||Hazard Ratio (HR)|1.1849||||0.6397|2-Sided|95.0|0.5817|2.4134||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.||
1608221|NCT02609984|2953738|Other||Hazard Ratio (HR)|0.7006||||0.1622|2-Sided|95.0|0.4241|1.1574||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.||
1608222|NCT02609984|2953739|Other|||||||0.3466||||||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||||
1608223|NCT02609984|2953740|Other|||||||0.3645||||||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||||
1608224|NCT02609984|2953744|Other||Hazard Ratio (HR)|1.2145||||0.4737|2-Sided|95.0|0.7131|2.0684||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.||
1608225|NCT02609984|2953745|Other||Hazard Ratio (HR)|0.8568||||0.49|2-Sided|95.0|0.5507|1.333||P-value based on a 2-sided stratified log-rank test stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.|Log Rank||Hazard ratio is from Cox proportional hazards model stratified by type of sarcoma: synovial sarcoma versus myxoid/round cell liposarcoma.||
1608226|NCT02609659|2953768|Non-Inferiority|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the 3-DAA + RBV 600 mg treatment group as compared with the historical rate for 3-DAA + weight-based RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 92% to achieve noninferiority.|percentage of participants|89.5|||||2-Sided|95.0|83.7|95.4|||||||
1608227|NCT02609178|2953799|Non-Inferiority or Equivalence|Stated above in statistical analysis 1.||||||0.141||||||Alpha value was set at 0.05.|Tukey's multiple comparison test||||
1608228|NCT02609178|2953799|Non-Inferiority or Equivalence|Stated above in statistical analysis 1.||||||0.005||||||Alpha value was set at 0.05.|Tukey's multiple comparison test||||
1608229|NCT02609178|2953799|Non-Inferiority or Equivalence|Stated above in statistical analysis 1.||||||0.308||||||Alpha value was set at 0.05.|Tukey's multiple comparison test||||
1608230|NCT02609178|2953799|Non-Inferiority or Equivalence|Using G*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.007||||||alpha value was set at 0.05|ANOVA||||
1608231|NCT02609178|2953800|Non-Inferiority or Equivalence|Stated above in statistical analysis 1.||||||0.002||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)||||
1608232|NCT02609178|2953800|Non-Inferiority or Equivalence|Stated above in statistical analysis 1.||||||0.001||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)||||
1608233|NCT02609178|2953800|Non-Inferiority or Equivalence|Stated above in statistical analysis 1.||||||0.579||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)||||
1608234|NCT02609178|2953800|Non-Inferiority or Equivalence|Using G*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.001||||||alpha value was set at 0.05|Kruskal-Wallis||||
1608235|NCT02609178|2953801|Non-Inferiority or Equivalence|Stated above in statistical analysis 1.||||||0.009||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)||||
1608236|NCT02609178|2953801|Non-Inferiority or Equivalence|Stated above in statistical analysis 1.||||||0.03||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)||||
1608237|NCT02609178|2953801|Non-Inferiority or Equivalence|Stated above in statistic analysis 1.||||||0.739||||||Alpha value was set at 0.05.|Wilcoxon (Mann-Whitney)||||
1608425|NCT02605122|2954167|Other||Achievement of Clinical Improvement|68.7|||||2-Sided|95.0|58.0|78.0|||||||
1608238|NCT02609178|2953801|Non-Inferiority or Equivalence|Using G*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.006||||||alpha value was set at 0.05|Kruskal-Wallis||||
1608239|NCT02609178|2953802|Non-Inferiority or Equivalence|Stated above in statistical analysis 1.||||||0.054||||||Alpha value was set at 0.05.|Tukey's multiple comparison test||||
1608240|NCT02609178|2953802|Non-Inferiority or Equivalence|Stated above in statistical analysis 1.||||||0.002||||||Alpha value was set at 0.05.|Tukey's multiple comparison test||||
1608241|NCT02609178|2953802|Non-Inferiority or Equivalence|stated above in statistical analysis 1||||||0.366||||||Alpha value was set at 0.05.|Tukey's multiple comparison test||||
1608242|NCT02609178|2953802|Non-Inferiority or Equivalence|Using G*power 3.1.7, setting α at 0.05, (1- β) at 0.8, the number of the subjects enrolled could reach the actual power as 0.8.||||||0.003||||||Alpha value was set at 0.05.|ANOVA||||
1608243|NCT02608892|2953820|Superiority|Use of pain management during newborn screening was described using frequency and proportion and expressed as an absolute difference in proportions with 95% confidence interval.|Absolute difference in proportions|-7.4|||||2-Sided|95.0|-26.2|11.5|||||||
1608244|NCT02608489|2953829|Superiority or Other|||||||0.151|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.|
1608245|NCT02608489|2953830|Superiority or Other|||||||0.034|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12|
1608246|NCT02608489|2953830|Superiority or Other|||||||0.002|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4|
1608247|NCT02608489|2953830|Superiority or Other|||||||0.001|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.|
1608248|NCT02608489|2953831|Superiority or Other|||||||0.045|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.|
1608249|NCT02608489|2953832|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12|
1608250|NCT02608489|2953832|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 4|
1608251|NCT02608489|2953832|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.|
1608252|NCT02608489|2953833|Superiority or Other|||||||0.021|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.|
1608253|NCT02608489|2953833|Superiority or Other|||||||0.08|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.|
1608254|NCT02608489|2953834|Superiority or Other|||||||0.025|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at Postoperative week 12 follow-up.|
1608255|NCT02608489|2953834|Superiority or Other|||||||0.256|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.|
1608256|NCT02608489|2953835|Superiority or Other|||||||0.015|||||||Mixed Models Analysis|||Linear mixed model was used to compare measurement data between the 2 groups by considering the correlation between both eyes of each patient at postoperative week 12 follow-up.|
1608257|NCT02608489|2953835|Superiority or Other|||||||0.221|||||||Mixed Models Analysis|||To obtain an overall comparison between treatment responses throughout the study period considering the 2 levels of correlation in subjects and follow-up, a linear mixed model with asymmetric random effects was used.|
1608258|NCT02607956|2953871|Other||Difference in LSM|-14.0||||0.48|2-Sided|95.0|-52.0|25.0|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.||
1608259|NCT02607956|2953872|Other||Difference in LSM|-47.0||||0.008|2-Sided|95.0|-81.0|-12.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.||
1608260|NCT02607956|2953873|Other||Difference in LSM|-23.0||||0.096|2-Sided|95.0|-49.0|4.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.||
1608261|NCT02607956|2953874|Other||Difference in LSM|0.09||||0.054|2-Sided|95.0|0.0|0.18|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.||
1608262|NCT02607956|2953875|Other||Difference in LSM|0.06||||0.18|2-Sided|95.0|-0.03|0.15|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.||
1608263|NCT02607956|2953876|Other||Difference in LSM|0.08||||0.081|2-Sided|95.0|-0.01|0.17|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.||
1608426|NCT02605122|2954168|Other||Achievement of ECR|62.1|||||2-Sided|95.0|49.0|74.0|||||||
1608264|NCT02607956|2953877|Other|||||||0.74|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).|||
1608265|NCT02607956|2953877|Other||Difference in Percentages|-1.1|||||2-Sided|95.0|-7.4|5.3|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).||
1608266|NCT02607956|2953878|Other|||||||0.44|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).|||
1608267|NCT02607956|2953878|Other||Difference in Percentages|-2.5|||||2-Sided|95.0|-8.8|3.8|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).||
1608268|NCT02607956|2953879|Other|||||||0.16|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).|||
1608269|NCT02607956|2953879|Other||Difference in Percentages|-3.9|||||2-Sided|95.0|-9.4|1.5|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).||
1608270|NCT02607956|2953880|Other|||||||0.52|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).|||
1608271|NCT02607956|2953880|Other||Difference in Percentages|-1.9|||||2-Sided|95.0|-7.8|3.9|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).||
1608272|NCT02607956|2953881|Other|||||||0.41|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).|||
1608273|NCT02607956|2953881|Other||Difference in Percentages|-2.3|||||2-Sided|95.0|-7.9|3.2|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).||
1608274|NCT02607956|2953882|Superiority|||||||0.12|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).|||
1608275|NCT02607956|2953882|Non-Inferiority|A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.|Difference in Percentages|-3.5|||||2-Sided|95.002|-7.9|1.0|||||Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).||
1608276|NCT02607930|2953887|Other||Difference in LSM|-0.406||||0.26|2-Sided|95.0|-1.119|0.307|||ANOVA||||
1608277|NCT02607930|2953888|Other||Difference in LSM|-0.485||||0.14|2-Sided|95.0|-1.126|0.155|||ANOVA||||
1608278|NCT02607930|2953889|Superiority||Difference in LSM|-0.221||||0.41|2-Sided|95.0|-0.741|0.3|||ANOVA||||
1608279|NCT02607930|2953890|Other||Difference in LSM|0.271||||0.39|2-Sided|95.0|-0.351|0.893|||ANOVA||||
1608280|NCT02607930|2953891|Other||Difference in LSM|0.135||||0.59|2-Sided|95.0|-0.356|0.625|||ANOVA||||
1608281|NCT02607930|2953892|Other||Difference in LSM|0.346||||0.092|2-Sided|95.0|-0.057|0.748|||ANOVA||||
1608282|NCT02607930|2953893|Other||Difference in LSM|-20.0||||0.3|2-Sided|95.0|-59.0|18.0|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.||
1608283|NCT02607930|2953894|Other||Difference in LSM|-1.0||||0.94|2-Sided|95.0|-39.0|36.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.||
1608284|NCT02607930|2953895|Other||Difference in LSM|6.0||||0.69|2-Sided|95.0|-24.0|36.0|||ANOVA|P-value was adjusted by the baseline HIV-1 RNA and region stratum.|Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.||
1608285|NCT02607930|2953896|Other||Difference in LSM|0.01||||0.88|2-Sided|95.0|-0.08|0.1|||ANOVA||Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.||
1608286|NCT02607930|2953897|Other||Difference in LSM|0.0||||0.99|2-Sided|95.0|-0.09|0.09|||ANOVA||Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.||
1608287|NCT02607930|2953898|Other||Difference in LSM|-0.03||||0.48|2-Sided|95.0|-0.12|0.06|||ANOVA|p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.|Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.||
1608288|NCT02607930|2953899|Other|||||||0.19|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).|||
1608289|NCT02607930|2953899|Other||Difference in Percentages|-4.2|||||2-Sided|95.0|-10.5|2.1|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).||
1608290|NCT02607930|2953900|Other|||||||0.69|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).|||
1608291|NCT02607930|2953900|Other||Difference in Percentages|-1.2|||||2-Sided|95.0|-6.9|4.6|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).||
1608427|NCT02605122|2954169|Other||Proportion experiencing TEAE or TESAE|34.3|||||2-Sided|95.0|23.0|47.0|||||||
1608292|NCT02607930|2953901|Other|||||||0.87|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).|||
1608293|NCT02607930|2953901|Other||Difference in Percentages|0.4|||||2-Sided|95.0|-4.8|5.6|||||The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).||
1608294|NCT02607930|2953902|Other|||||||0.39|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).|||
1608295|NCT02607930|2953902|Other||Difference in Percentages|-2.6|||||2-Sided|95.0|-8.5|3.4|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).||
1608296|NCT02607930|2953903|Other|||||||0.45|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).|||
1608297|NCT02607930|2953903|Other||Difference in Percentages|-1.9|||||2-Sided|95.0|-6.9|3.1|||||Differences in percentages of participants between groups and their 95% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).||
1608298|NCT02607930|2953904|Superiority|||||||0.78|||||||Cochran-Mantel-Haenszel|p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).|||
1608299|NCT02607930|2953904|Non-Inferiority|A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.|Difference in Percentages|-0.6|||||2-Sided|95.002|-4.8|3.6|||||Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).||
1608300|NCT02607865|2953924|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.31|||<|0.0001|2-Sided|95.0|0.22|0.43||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1608301|NCT02607865|2953924|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.66|||=|0|2-Sided|95.0|0.51|0.86||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1608302|NCT02607865|2953924|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.33|||=|0|2-Sided|95.0|1.05|1.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Sitagliptin 100 mg|Time to initiation of rescue medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Censoring time was one day before last day on trial product.|
1608303|NCT02607865|2953925|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.53|||<|0.0001|2-Sided|95.0|0.41|0.68||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 14 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1608304|NCT02607865|2953925|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|0.77|||=|0|2-Sided|95.0|0.61|0.96||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 7 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1608305|NCT02607865|2953925|Superiority|This hypothesis was not controlled for multiplicity.|Hazard Ratio (HR)|1.34|||=|0|2-Sided|95.0|1.09|1.65||Unadjusted two-sided p-value for test of no difference from 1.|Regression, Cox||Oral semaglutide 3 mg / Sitagliptin 100 mg|Time to initiation of additional anti-diabetic medication was analysed using a Cox proportional hazards model with treatment, strata, and region as categorical fixed effects and baseline HbA1c as covariate. Withdrawal for any reason or lost to follow-up contributed to the analysis as events (initiation of additional anti-diabetic medication). Censoring time was one day before planned end of treatment.|
1608306|NCT02607865|2953946|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|type Mean treatment difference|-0.5|||=|0|2-Sided|95.0|-1.0|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1608376|NCT02605395|2954131|Equivalence|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC (0 to infinity) to be within 80-125% to prove equivalency.|Ratio of means|95.69|||||2-Sided|90.0|87.06|105.17|||||||
1609330|NCT02572817|2956455|Superiority||Odds Ratio (OR)|1.42||||0.98|2-Sided|95.0|0.23|11.01|||Regression, Logistic||||
1608307|NCT02607865|2953946|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-1.5|||<|0.0001|2-Sided|95.0|-2.0|-1.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1608308|NCT02607865|2953946|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-2.6|||<|0.0001|2-Sided|95.0|-3.1|-2.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline body weight value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1608309|NCT02607865|2953946|Superiority|This hypothesis was not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.6|||=|0|2-Sided|95.0|-1.1|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1608310|NCT02607865|2953946|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-1.6|||<|0.0001|2-Sided|95.0|-2.0|-1.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1608311|NCT02607865|2953946|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-2.5|||<|0.0001|2-Sided|95.0|-3.0|-2.0||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline body weight value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1608312|NCT02607865|2953947|Other|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|0.2|||<|0.0001|2-Sided|95.0|0.1|0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value.|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1608313|NCT02607865|2953947|Non-Inferiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|0.2|||=|0|2-Sided|95.0|0.1|0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1608330|NCT02607306|2954006|Non-Inferiority|Non-inferiority of IDegLira vs. IDeg was confirmed if the 95% confidence interval for the mean treatment difference lies entirely below 0.3%.|Treatment contrast|-0.63|||<|0.0001|2-Sided|95.0|-0.75|-0.52||p-value for non-inferiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.|
1608314|NCT02607865|2953947|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.3|||<|0.0001|2-Sided|95.0|-0.4|-0.2||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1608315|NCT02607865|2953947|Non-Inferiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.3|||<|0.0001|2-Sided|95.0|-0.4|-0.2||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1608316|NCT02607865|2953947|Superiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|2-Sided|95.0|-0.7|-0.5||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a MMRM that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1608317|NCT02607865|2953947|Non-Inferiority|This hypothesis was not controlled for multiplicity. Results are based on the data from the on-treatment without rescue medication observation period. The estimated treatment effect excludes the effect of any rescue medication and any effect after premature trial product discontinuation (hypothetical estimand).|Mean treatment difference|-0.6|||<|0.0001|2-Sided|95.0|-0.7|-0.5||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|MMRM||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a mixed model for repeated measurements (MMRM) that assumed data to be missing at random. As dependent variables, the MMRM model included all post-baseline values collected at scheduled visits up to and including week 26. The independent effects were treatment, strata and region as categorical fixed effects and the baseline HbA1c value as a covariate, all nested within visit, and an unstructured residual covariance matrix.|
1608318|NCT02607865|2953947|Superiority|This hypothesis was not controlled for multiplicity, since the non-inferiority test of change in HbA1c for oral semaglutide 3 mg versus sitagliptin 100 mg could not be confirmed. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|0.2|||=|0|2-Sided|95.0|0.0|0.3||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg. If the mean treatment difference is non-negative, the superiority hypothesis of oral semaglutide 3 mg vs sitagliptin 100 mg will never be confirmed irrespective of the observed two-sided p-value.|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1608319|NCT02607865|2953947|Non-Inferiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|0.2|||=|0|2-Sided|95.0|0.1|0.3||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 3 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1608320|NCT02607865|2953947|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.3|||<|0.0001|2-Sided|95.0|-0.4|-0.1||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1608374|NCT02605837|2954105|Superiority||Difference in proportion of responders|0.13||||0.024||95.0|0.016|0.243|||Cochran-Mantel-Haenszel|||The CMH adjusted difference in proportion with corresponding Newcombe confidence interval (CI) and odds ratio with corresponding CI were based on CMH test stratified by age group and diet restriction.|
1608321|NCT02607865|2953947|Non-Inferiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.2|||<|0.0001|2-Sided|95.0|-0.4|-0.1||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 7 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1608322|NCT02607865|2953947|Superiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand).|Mean treatment difference|-0.5|||<|0.0001|2-Sided|95.0|-0.6|-0.4||Unadjusted two-sided p-value for test of no difference from 0 (superiority).|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an ANCOVA model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1608323|NCT02607865|2953947|Non-Inferiority|This hypothesis was controlled for multiplicity. Results are based on the data from the in-trial observation period. The estimated treatment effect includes the effect of any rescue medication and any effect after premature trial product discontinuation (treatment policy estimand). A value of 0.3% (the non-inferiority margin) was added to imputed values at week 26 for the oral semaglutide treatment arm only.|Mean treatment difference|-0.5|||<|0.0001|2-Sided|95.0|-0.6|-0.4||Unadjusted two-sided p-value for test of no difference from the non-inferiority margin (non-inferiority). The non-inferiority margin was 0.3%.|Pattern mixture model||Oral semaglutide 14 mg - Sitagliptin 100 mg|The analysis was based on a pattern mixture model using multiple imputation to handle missing week 26 data, assuming that data were missing at random within the groups used for imputation. The imputed data sets were analysed using an analysis of covariance (ANCOVA) model with treatment, strata, and region as categorical fixed effects and baseline HbA1c value as covariate for each of the 1000 imputed complete data sets, and pooled by Rubin's rule to draw inference.|
1608324|NCT02607800|2953953|Non-Inferiority|Noninferiority was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 was greater than −5%. If the lower bound of the CI was greater than −5% (ie, the noninferiority null hypothesis was rejected), a 2-sided stratified Cochran-Mantel-Haenszel test was to be used to test for the superiority of SOF/VEL/VOX for 8 weeks over SOF/VEL for 12 weeks at a significance level of 0.05.|Difference in proportions|-3.2|||||2-Sided|95.0|-6.0|-0.4|||||Difference in proportions between treatment groups and associated 95% CI were calculated based on stratum-adjusted Mantel-Haenszel proportions.||
1608325|NCT02607735|2953964|Superiority|The SVR12 rate for the SOF/VEL/VOX group was compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.|||||<|0.001|||||||2-sided exact 1-sample binomial test||||
1608326|NCT02607306|2954003|Superiority|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|-0.63|||<|0.0001|2-Sided|95.0|-0.75|-0.52||p-value for superiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment, pre-trial OAD as fixed factors and corresponding baseline HbA1c value as covariate.|
1608327|NCT02607306|2954004|Superiority|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|0.48|||<|0.0001|2-Sided|95.0|0.35|0.68||p-value for superiority of IDegLira vs IDeg is presented|Negative binomial regression|||The number of events is analysed using a negative binomial regression model (log link) with the logarithm of the treatment emergent exposure time (100 years) as offset. The model includes treatment and pre-trial OAD treatment as fixed factors.|
1608328|NCT02607306|2954005|Superiority|A hierarchical testing procedure is used to control the overall type I error on a two sided 5% level. If and only if non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Lira are confirmed in the primary analysis (change in HbA1c), the three secondary confirmatory tests are performed for superiority of IDegLira versus IDeg with a fixed sequence (1. change in body weight, 2. number of treatment emergent severe or BG confirmed hypoglycaemic episodes and 3. change in HbA1c).|Treatment contrast|-1.19||||0.0001|2-Sided|95.0|-1.8|-0.59||p-value for superiority of IDegLira vs IDeg is presented|ANCOVA|||The change from baseline in response after 52 weeks were analysed using an ANCOVA method with treatment and pre-trial OAD treatment as fixed factors and baseline body weight as covariate.|
1608329|NCT02607306|2954006|Superiority|Superiority of IDegLira vs. Lira was confirmed if the 95% confidence interval for the mean treatment difference for change from baseline in HbA1c lies entirely below 0.0%.|Treatment contrast|-0.48|||<|0.0001|2-Sided|95.0|-0.6|-0.37||p-value for superiority of IDegLira vs Lira is presented|ANCOVA|||The change from baseline in response after 52 weeks are analysed using an ANCOVA model with treatment and pre-trial OAD as fixed factors and baseline HbA1c value as covariate.|
1608377|NCT02605395|2954132|Equivalence|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for AUC(0-t) to be within 80-125% to prove equivalency.|Ratio of means|96.5|||||2-Sided|90.0|90.02|103.44|||||||
1608331|NCT02606903|2954012|Superiority or Other||Ratio of adjusted geometric means (%)|100.22|Standard Deviation|53.137|||2-Sided|90.0|82.13|122.29|||||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and BMI group as fixed effects|
1608332|NCT02606903|2954013|Superiority or Other||Ratio of adjusted geometric means (%)|100.14|Standard Deviation|42.354|||2-Sided|90.0|85.15|117.76|||||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and BMI group as fixed effects|
1608333|NCT02606903|2954014|Superiority or Other||Ratio of adjusted geometric means (%)|110.19|Standard Deviation|33.603|||2-Sided|90.0|96.8|125.44|||||Relative bioavailability was estimated by the ratio (AI/PFS) of the adjusted geometric means (gMean). Standard deviation is actually inter-individual geometric coefficient of variation (%).|Analysis of variance (ANOVA) model on the log scale was used including treatment and body mass index (BMI) group as fixed effects|
1608334|NCT02606877|2954015|Other||T1/R1 Ratio (%)|89.49|Standard Deviation|44.3|||2-Sided|90.0|66.33|120.73|||||To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).||
1608335|NCT02606877|2954016|Other||T2/R2 Ratio (%)|99.49|Standard Deviation|17.4|||2-Sided|90.0|87.94|112.56|||||To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T2 and R2 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).||
1608336|NCT02606877|2954017|Other||T2/R2 Ratio (%)|97.17|Standard Deviation|14.1|||2-Sided|90.0|87.84|107.48|||||To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T2 and R2 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).||
1608337|NCT02606877|2954018|Other||T1/R1 Ratio (%)|80.63|Standard Deviation|74.6|||2-Sided|90.0|51.27|126.79|||||To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).||
1608338|NCT02606877|2954019|Other||T1/R1 Ratio (%)|88.58|Standard Deviation|45.1|||2-Sided|90.0|65.4|119.97|||||To get,geometric mean ratio and Confidence Interval,least square estimates of log-transformed PK endpoint for T1 and R1 were back transformed to original scale. Standard Deviation is actually the intra-individual geometric Coefficient of Variance(%).||
1608339|NCT02606643|2954028|Superiority or Other|||||||0.814|||||||Chi-squared|||an alpha level of .05, and a level of power of 80%. These parameters required a sample size of 63 patients per group|
1608340|NCT02606500|2954040|Non-Inferiority|We presumed Elonva 150 mcg in obese and normal weighing women yields comparable biochemical pregnancy rates.||||||0.4|||||||Regression, Logistic||||
1608341|NCT02606500|2954041|Non-Inferiority|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.9|||||||Regression, Logistic||||
1608342|NCT02606500|2954042|Non-Inferiority|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.3|||||||Regression, Logistic||||
1608343|NCT02606500|2954043|Non-Inferiority|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.5|||||||Regression, Logistic||||
1608344|NCT02606500|2954044|Non-Inferiority|We hypothesized that Elonva 150 mcg is non-inferior for COH in obese women.||||||0.9|||||||Regression, Logistic||||
1608345|NCT02605993|2954068|Other|||||||0.2302||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.|
1608346|NCT02605993|2954068|Other|||||||0.09||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.|
1608347|NCT02605993|2954069|Other|||||||0.0705||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.|
1608348|NCT02605993|2954070|Other|||||||0.6296||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.|
1608349|NCT02605993|2954070|Other|||||||0.4686||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.|
1608350|NCT02605993|2954071|Other|||||||0.252||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.|
1608351|NCT02605993|2954071|Other|||||||0.4037||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.|
1608352|NCT02605993|2954072|Other|||||||0.3641||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281.|
1608353|NCT02605993|2954072|Other|||||||0.698||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|MMRM|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253.|
1608375|NCT02605837|2954106|Superiority||Difference in proportion of responders|0.52|||<|0.001||95.0|0.433|0.591|||Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) adjusted difference in proportion with corresponding Newcombe confidence interval (CI) and odds ratio with corresponding CI were based on CMH test stratified by age group and diet restriction.|
1608423|NCT02605174|2954165|Superiority||Odds Ratio (OR)|1.5|||<|0.003|2-Sided|95.0|1.1|1.9|||Regression, Logistic||||
1608354|NCT02605993|2954073|Other||||||<|0.0001||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0.|MMRM|||Statistical Analysis presented is of Cohort 4 at Day 281. A sample size of 20 participants from the combined cohorts was required to provide approximately 95% power to detect a mean paired difference in LDH from Baseline of –40% at Day 281 for Cohort 4 only, with an estimated SD of 45%. This was based on a 2-sided paired t-test, with 5% type I error rate. To account for a possible 15% dropout rate, up to 26 participants were enrolled.|
1608355|NCT02605993|2954073|Other||||||<|0.0001||||||Hypothesis testing was performed at the 0.05 level of significance. P-value tested whether the percent changes differed from 0 for the combined cohorts.|Mixed Model for Repeated Measures (MMRM)|||Statistical Analysis presented is of Cohorts 1 to 4 combined at Day 253. A sample size of 20 participants from the combined cohorts was required to provide approximately 95% power to detect a mean paired difference in LDH from Baseline of –40% at Day 253 for Cohorts 1 to 4, with an estimated standard deviation (SD) of 45%. This was based on a 2-sided paired t-test, with 5% type I error rate. To account for a possible 15% dropout rate, up to 26 participants were enrolled.|
1608356|NCT02605954|2954075|Other||Difference in least square mean|-36.0||||0.11|2-Sided|95.0|-80.0|9.0|||ANOVA||||
1608357|NCT02605954|2954077|Non-Inferiority|With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the delayed switch group at Week 12, the lower limit of the observed one sided 97.5% confidence interval will be expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with > 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 12.|Difference in Percentages|-3.8||||0.17|2-Sided|95.0|-8.3|1.6|||Fisher Exact||||
1608358|NCT02605954|2954078|Non-Inferiority|With 200 participants randomized to switch to the E/C/F/TAF FDC group at Day 1 and 100 participants randomized to the ABC/3TC+3rd Agent group at Week 24, the lower limit of the observed one sided 97.5% confidence interval was expected to be greater than -0.120 (ie, non-inferiority margin of 12%) with > 90% power when the percentage of responders in both treatment groups for the primary endpoint is at least 90% at Week 24.|Difference in Percentages|-4.4||||0.15|2-Sided|95.0|-9.4|1.9|||Fisher Exact||||
1608359|NCT02605837|2954095|Superiority||Difference in Least square mean|-2.46||||0.002||95.0|-4.018|-0.909|||ANCOVA|||This analysis was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ Pain score as a continuous covariate.|
1608360|NCT02605837|2954096|Superiority||Difference in Least square mean|-6.41||||0.004||95.0|-10.757|-2.063|||ANCOVA|||This analysis was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ + Pain score as a continuous covariate.|
1608361|NCT02605837|2954097|Superiority||Odds Ratio (OR)|61.68||||0.004|2-Sided|95.0|3.836|991.858|||Firth logistic regression|||Overall binary response II at the final treatment period was perfomed based on based on firth logistic regression model adjusted for age group and diet restriction.|
1608362|NCT02605837|2954098|Superiority||Odds Ratio (OR)|91.86||||0.001|2-Sided|95.0|5.687|1483.68|||Firth logistic regression|||Overall binary response I at the final treatment period was performed based on firth logistic regression model adjusted for age group and diet restriction.|
1608363|NCT02605837|2954099|Superiority||Odds Ratio (OR)|1.42||||0.164|2-Sided|95.0|0.866|2.333|||Regression, Logistic|||Dysphagia symptom response (binary response) at the final treatment period was performed based on logistic regression model adjusted for age group and diet restriction.|
1608364|NCT02605837|2954100|Superiority||Difference in Least square mean|-0.2|||<|0.001||95.0|-0.2|-0.2|||ANCOVA|||This analysis of histopathologic epithelial features combined stage TSR was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.|
1608365|NCT02605837|2954100|Superiority||Difference in Least square mean|-0.19|||<|0.001||95.0|-0.22|-0.16|||ANCOVA|||This analysis of histopathologic epithelial features combined grade TSR was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.|
1608366|NCT02605837|2954101|Superiority||Difference in LS Mean|-47.6|||<|0.001|2-Sided|95.0|-56.4|-38.8|||ANCOVA|||This analysis of maximum eosinophil count was from the ANCOVA model with treatment group and age group as factors and the baseline Peak eosinophil count as a continuous covariate.|
1608367|NCT02605837|2954101|Superiority||Difference in Least square mean|-33.1|||<|0.001||95.0|-40.7|-25.5|||ANCOVA|||This analysis of distal eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate|
1608368|NCT02605837|2954101|Superiority||Difference in Least square mean|-30.4|||<|0.001||95.0|-38.1|-22.7|||ANCOVA|||This analysis of mid eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.|
1608369|NCT02605837|2954101|Superiority||Difference in Least square mean|-28.4|||<|0.001||95.0|-35.0|-21.8|||ANCOVA|||This analysis of proximal eosinophil count was from the analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline Peak Eosinophil Count as a continuous covariate.|
1608370|NCT02605837|2954102|Superiority||Odds Ratio (OR)|100.69||||0.001|2-Sided|95.0|6.294|1610.749|||Firth logistic regression|||Peak eosinophil count (<=1/HPF) was performed based on firth logistic regression model adjusted for age group and diet restriction.|
1608371|NCT02605837|2954102|Superiority||Odds Ratio (OR)|169.74|||<|0.001||95.0|23.235|1239.979|||Regression, Logistic|||Peak eosinophil count (<15/HPF) was performed based on logistic regression model adjusted for age group and diet restriction.|
1608372|NCT02605837|2954103|Superiority||Difference in Least square mean|-1.8|||<|0.001||95.0|-2.6|-1.1|||ANCOVA|||This analysis was from analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline. Total EREFS (endoscopy score) as a continuous covariate.|
1608373|NCT02605837|2954104|Superiority||Difference in Least square mean|-3.92||||0.015||95.0|-7.073|-0.774|||ANCOVA|||This analysis was from analysis of covariance (ANCOVA) model with treatment group and age group as factors and the baseline DSQ combined score as a continuous covariate.|
1608424|NCT02605122|2954166|Other||Achievement of Clinical Cure|62.0|||||2-Sided|95.0|50.0|73.0|||||||
1608378|NCT02605395|2954133|Equivalence|The confidence intervals of logarithmically transformed ratio (Idiazole/Pariet) for Cmax to be within 80-125% to prove equivalency.|Ratio of means|95.71|||||2-Sided|90.0|90.12|101.65|||||||
1608379|NCT02605187|2954142|Superiority|||||||0.873|||||||ANOVA|||Comparison of satisfaction with pain medication 48 hours after delivery.|
1608380|NCT02605187|2954142|Superiority|||||||0.019|||||||ANOVA|||Comparison of satisfaction with pain medication 24 hours after delivery.|
1608381|NCT02605187|2954143|Superiority|||||||0.036|||||||ANOVA||||
1608382|NCT02605187|2954144|Superiority|||||||0.226|||||||ANOVA|||Comparison of average number of vomiting episodes 0-24 hours after delivery. Null Hypothesis: all means are equal|
1608383|NCT02605187|2954145|Superiority|||||||0.246|||||||Fisher Exact|||Comparison of participants who need nausea treatment from 24-48 hours after delivery.|
1608384|NCT02605187|2954145|Superiority|||||||0.057|||||||Chi-squared|||Comparison of participants who need nausea treatment from 0-24 hours after delivery.|
1608385|NCT02605187|2954146|Superiority|||||||0.985|||||||ANOVA|||Comparison of nausea score at 48 hours after delivery. Null Hypothesis: all means are equal|
1608386|NCT02605187|2954146|Superiority|||||||0.786|||||||ANOVA|||Comparison of nausea score 24 hours after delivery. Null Hypothesis: all means are equal|
1608387|NCT02605187|2954147|Superiority|||||||0.281|||||||Chi-squared||||
1608388|NCT02605187|2954148|Superiority|||||||0.761|||||||Fisher Exact|||Comparison of participants who need medical treatment of pruritus 24-48 hours after delivery.|
1608389|NCT02605187|2954148|Superiority|||||||0.759|||||||Fisher Exact|||Comparison of participants who need medical treatment of pruritus 0-24 hours after delivery.|
1608390|NCT02605187|2954149|Superiority|||||||0.296|||||||ANOVA|||Comparison of pruritus score 48 hours after delivery. Null Hypothesis: all means are equal|
1608391|NCT02605187|2954149|Superiority|||||||0.006|||||||ANOVA|||Comparison of pruritus score 24 hours after delivery. Null Hypothesis: all means are equal|
1608392|NCT02605187|2954150|Superiority|||||||0.269|||||||Fisher Exact|||Comparison of presence of pruritus 24-48 hours after delivery.|
1608393|NCT02605187|2954150|Superiority|||||||0.092|||||||Fisher Exact|||Comparison of presence of pruritus 0-24 hours after delivery.|
1608394|NCT02605187|2954151|Superiority|||||||0.008||||||Final parameter estimates would be considered significant at P < 0.05.|Fisher Exact|||Comparison of opioid use 24-48 hours after delivery.|
1608395|NCT02605187|2954151|Superiority|||||||0.311||||||Final parameter estimates would be considered significant at P < 0.05.|Fisher Exact|||Comparison of opioid use 0-24 hours after delivery.|
1608396|NCT02605187|2954152|Superiority|||||||0.14||||||Final parameter estimates would be considered significant at P < 0.05.|ANOVA|||Comparison of pain at movement 48 hours after delivery. Null Hypothesis: all the means are the same.|
1608397|NCT02605187|2954152|Superiority|||||||0.022||||||Final parameter estimates would be considered significant at P < 0.05.|ANOVA|||Comparison of pain at rest 48 hours after delivery. Null Hypothesis: all the means are the same.|
1608398|NCT02605187|2954152|Superiority|||||||0.565||||||Final parameter estimates would be considered significant at P < 0.05.|ANOVA|||Comparison of pain at movement 24 hours after delivery. Null Hypothesis: all the means are the same.|
1608399|NCT02605187|2954152|Superiority|||||||0.882||||||Final parameter estimates would be considered significant at P < 0.05.|ANOVA|||Comparison of pain at rest 24 hours after delivery. Null Hypothesis: all the means are the same.|
1608400|NCT02605174|2954156|Superiority||Odds Ratio (OR)|1.8|||<|0.001|2-Sided|95.0|1.4|2.3|||Regression, Logistic||||
1608401|NCT02605174|2954156|Superiority||Odds Ratio (OR)|1.7|||<|0.001|2-Sided|95.0|1.3|2.1|||Regression, Logistic||||
1608402|NCT02605174|2954156|Superiority||Odds Ratio (OR)|1.4|||<|0.007|2-Sided|95.0|1.1|1.7|||Regression, Logistic||||
1608403|NCT02605174|2954157|Superiority||Odds Ratio (OR)|1.6|||<|0.001|2-Sided|95.0|1.3|2.1|||Regression, Logistic||||
1608404|NCT02605174|2954157|Superiority||Odds Ratio (OR)|1.6|||<|0.001|2-Sided|95.0|1.3|2.0|||Regression, Logistic||||
1608405|NCT02605174|2954157|Superiority||Odds Ratio (OR)|1.4|||<|0.008|2-Sided|95.0|1.1|1.7|||Regression, Logistic||||
1608406|NCT02605174|2954158|Superiority||Odds Ratio (OR)|1.0||||0.992|2-Sided|95.0|0.8|1.3|||Regression, Logistic||||
1608407|NCT02605174|2954158|Superiority||Odds Ratio (OR)|1.1||||0.622|2-Sided|95.0|0.8|1.4|||Regression, Logistic||||
1608408|NCT02605174|2954158|Superiority||Odds Ratio (OR)|0.9||||0.522|2-Sided|95.0|0.7|1.2|||Regression, Logistic||||
1608409|NCT02605174|2954160|Superiority||Odds Ratio (OR)|0.8||||0.456|2-Sided|95.0|0.6|1.3|||Regression, Logistic||||
1608410|NCT02605174|2954160|Superiority||Odds Ratio (OR)|0.7||||0.129|2-Sided|95.0|0.5|1.1|||Regression, Logistic||||
1608411|NCT02605174|2954160|Superiority||Odds Ratio (OR)|1.0||||0.917|2-Sided|95.0|0.7|1.5|||Regression, Logistic||||
1608412|NCT02605174|2954161|Superiority||Odds Ratio (OR)|0.3|||<|0.001|2-Sided|95.0|0.3|0.4|||Regression, Logistic||||
1608413|NCT02605174|2954161|Superiority||Odds Ratio (OR)|0.5|||<|0.001|2-Sided|95.0|0.4|0.7|||Regression, Logistic||||
1608414|NCT02605174|2954161|Superiority||Odds Ratio (OR)|0.7|||<|0.002|2-Sided|95.0|0.5|0.9|||Regression, Logistic||||
1608415|NCT02605174|2954163|Superiority||Odds Ratio (OR)|2.4|||<|0.001|2-Sided|95.0|1.8|3.1|||Regression, Logistic||||
1608416|NCT02605174|2954163|Superiority||Odds Ratio (OR)|2.3|||<|0.001|2-Sided|95.0|1.7|2.9|||Regression, Logistic||||
1608417|NCT02605174|2954163|Superiority||Odds Ratio (OR)|1.7|||<|0.001|2-Sided|95.0|1.3|2.2|||Regression, Logistic||||
1608418|NCT02605174|2954164|Superiority||Odds Ratio (OR)|1.9|||<|0.001|2-Sided|95.0|1.4|2.4|||Regression, Logistic||||
1608419|NCT02605174|2954164|Superiority||Odds Ratio (OR)|1.6|||<|0.001|2-Sided|95.0|1.2|2.0|||Regression, Logistic||||
1608420|NCT02605174|2954164|Superiority||Odds Ratio (OR)|1.4|||<|0.009|2-Sided|95.0|1.1|1.8|||Regression, Logistic||||
1608421|NCT02605174|2954165|Superiority||Odds Ratio (OR)|2.3|||<|0.001|2-Sided|95.0|1.8|3.1|||Regression, Logistic||||
1608422|NCT02605174|2954165|Superiority||Odds Ratio (OR)|1.7|||<|0.001|2-Sided|95.0|1.3|2.2|||Regression, Logistic||||
1608428|NCT02604810|2954171|Non-Inferiority|Method of estimation = least-squares means based on analysis of variance (ANOVA) with a mixed-effect model. The lower bound of the 90% confidence interval (CI) for the geometric LSM ratio (SC/IV) of the primary PK endpoint of steady state AUC0-7 days for the PK population should be above 0.80.|Geometric least-squares mean ratio|1.04|||||2-Sided|90.0|1.0|1.07|||||||
1608429|NCT02604433|2954198|Superiority|||||||0.1127||||||Significance level of 0.050 for 2-sided tests.|negative binomial regression|||Negative binomial regression with the geograhiclal regions defined at randomization and baseline transfusion frequency as predictor variables.|
1608430|NCT02604433|2954199|Superiority||Mean Difference (Final Values)|-9.8||||0.8091|2-Sided|95.0|-90.0|70.4||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided||luspatercept - placebo|>=50% Transfusion Burden Reduction|
1608431|NCT02604433|2954199|Superiority||Mean Difference (Final Values)|-63.1||||0.0002|2-Sided|95.0|-96.3|-29.9||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided||luspatercept - placebo|>=33% Transfusion Burden Reduction|
1608432|NCT02604433|2954202|Superiority||Odds Ratio (OR)|6.76||||0.0036|2-Sided|95.0|1.56|29.28||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.|
1608433|NCT02604433|2954205|Superiority|||||||0.303||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Change from Baseline to Week 48|
1608434|NCT02604433|2954205|Superiority|||||||0.839||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Change from Baseline to Week 24|
1608435|NCT02604433|2954206|Superiority|||||||0.564||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Change from Baseline to Week 48|
1608436|NCT02604433|2954206|Superiority|||||||0.857||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Change from Baseline to Week 24|
1608437|NCT02604433|2954207|Superiority|||||||0.929||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Change from Baseline to Week 48|
1608438|NCT02604433|2954207|Superiority|||||||0.918||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Change from Baseline to Week 24|
1608439|NCT02604433|2954208|Superiority|||||||0.238||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Change from Baseline to Week 48|
1608440|NCT02604433|2954208|Superiority|||||||0.666||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Change from Baseline to Week 24|
1608441|NCT02604433|2954209|Superiority|||||||0.873||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Change from Baseline to Week 48|
1608442|NCT02604433|2954209|Superiority|||||||0.384||||||Significance level of 0.050 for 2-sided tests.|t-test, 2 sided|||Change from Baseline to Week 24|
1608443|NCT02604433|2954210|Superiority||LSM Difference|-2.39||||0.0391|2-Sided|95.0|-4.67|-0.12||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline myocardial T2* as covariates.|luspatercept - placebo|Change from baseline at Week 48 LSM = least square mean|
1608444|NCT02604433|2954211|Superiority||LSM Difference|0.01||||0.3998|2-Sided|95.0|-0.02|0.04||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.|luspatercept - placebo|Spine Bone Mineral Density: Change from baseline at Week 48 LSM = least squares mean|
1608445|NCT02604433|2954211|Superiority||LSM Difference|0.0||||0.7931|2-Sided|95.0|-0.01|0.01||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline BMD measurement as covariates.|luspatercept - placebo|Hip Bone Mineral Density: Change from baseline at Week 48 LSM = least squares mean|
1608446|NCT02604433|2954212|Superiority||LSM Difference|-347.8|||<|0.0001|2-Sided|95.0|-516.95|-178.65||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates based on an ANCOVA model with geographical regions defined at randomization and baseline serum ferritin as covariates.|luspatercept - placebo|Change from baseline at Week 48 LSM = least squares mean|
1608447|NCT02604433|2954213|Superiority||LSM Difference|17.3||||0.8998|2-Sided|95.0|-305.3|339.9||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|DM/D = Deferoxamine Mesilate / Deferoxamine: Change from baseline at Week 48 LSM = least squares mean|
1608448|NCT02604433|2954213|Superiority||LSM Difference|151.7||||0.7089|2-Sided|95.0|-664.7|968.1||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferiprone: Change from baseline at Week 48 LSM = least squares mean|
1608449|NCT02604433|2954213|Superiority||LSM Difference|-63.5||||0.3149|2-Sided|95.0|-187.9|60.9||Significance level of 0.050 for 2-sided tests|ANCOVA|Estimates are based on an ANCOVA model with geographical regions defined at randomization and baseline ICT as covariates.|luspatercept - placebo|Deferasirox: Change from baseline at Week 48 LSM = least squares mean|
1608450|NCT02604433|2954214|Superiority||LSM Difference|0.11||||0.8685|2-Sided|95.0|-1.16|1.38||Significance level of 0.050 for 2-sided tests.|ANCOVA||luspatercept - placebo|Change from baseline at Week 48 P-value ANCOVA model with geographical regions defined at randomization and baseline LIC as covariates. LSM = least square mean|
1608451|NCT02604433|2954215|Superiority||LSM Difference|-1.35|||<|0.0001|2-Sided|95.0|-1.77|-0.93||Significance level of 0.050 for 2-sided tests.|ANCOVA|Estimates were based on an ANCOVA model with geographical regions defined at randomization and baseline transfusion burden as covariates.|luspatercept - placebo|Change from baseline at Week 48 LSM = least squares mean|
1608452|NCT02604433|2954216|Superiority||Odds Ratio (OR)|11.92||||0.0017|2-Sided|95.0|1.65|86.29||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio, 95% CIs, and p-value were estimated from the Cochran-Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate, the testing procedure was done strictly in order: the test for this outcome was only conducted when there was evidence showing erythroid response was achieved in the luspatercept group for the primary endpoint, and achievement of objective in the luspatercept group in outcomes 2+3.|
1609804|NCT02559206|2957530|Superiority||Odds Ratio (OR)|1.71||||0.1663|2-Sided|95.0|0.79|3.7|||Cochran-Mantel-Haenszel||||
1608453|NCT02604433|2954217|Superiority||Odds Ratio (OR)|4.55||||0.0303|2-Sided|95.0|1.03|20.11||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio, 95% CIs, and p-value were estimated from the Cochran-Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate, the testing procedure was done strictly in order: the test for this outcome was only conducted when there was evidence showing erythroid response was achieved in the luspatercept group for the primary endpoint, and 33% hematological improvement was achieved in the luspatercept group in outcome 2.|
1608454|NCT02604433|2954218|Superiority||Odds Ratio (OR)|6.44|||<|0.0001|2-Sided|95.0|2.27|18.26||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% CIs, and p-value were estimated from the CMH test stratified by the geographical regions defined at randomization. To control the overall Type 1 error rate for outcomes 2-4, the testing procedure was implemented strictly in order: the test for this outcome was only conducted when there was evidence showing that erythroid response was achieved in the luspatercept group from Week 13 to Week 24 (primary endpoint).|
1608455|NCT02604433|2954219|Superiority||Odds Ratio (OR)|5.79|||<|0.0001|2-Sided|95.0|2.24|14.97||Significance level of 0.050 for 2-sided tests.|Cochran-Mantel-Haenszel|||Odds ratio 95% confidence intervals (CIs), and p-value were estimated from the Cochran Mantel-Haenszel (CMH) test stratified by the geographical regions defined at randomization.|
1608456|NCT02604407|2954221|Superiority or Other||Difference of LS Mean|-13.4|||<|0.001|2-Sided|95.0|-17.1|-9.7|||Mixed-effects model for repeated measure||Between treatment groups of SHP465 37.5 mg and Placebo.||
1608457|NCT02604407|2954221|Superiority or Other||Difference of LS Mean|-8.1|||<|0.001|2-Sided|95.0|-11.7|-4.4|||Mixed-effects model for repeated measure||Between treatment groups of SHP465 12.5 mg and Placebo.||
1608458|NCT02604342|2954244|Superiority||Difference in C-ORR|0.667|||<|0.001|2-Sided|95.0|0.39|0.86|||Chi-squared|||95% confidence interval of the difference (alectinib - chemotherapy) computed using Hauck-Anderson approach.|
1608459|NCT02604342|2954245|Superiority||Hazard Ratio (HR)|0.2|||<|0.001|2-Sided|95.0|0.12|0.33|||Stratified log-rank test||Estimated hazard ratio obtained from stratified Cox model with treatment group as covariate.||
1608460|NCT02604212|2954256|Superiority|||||||0.0849|||||||Fisher Exact||||
1608461|NCT02604212|2954256|Superiority|||||||0.0849|||||||Fisher Exact||||
1608462|NCT02604212|2954256|Superiority|||||||1|||||||Fisher Exact||||
1608463|NCT02604212|2954257|Superiority|||||||0.043|||||||Fisher Exact||||
1608464|NCT02604212|2954257|Superiority|||||||0.0179|||||||Fisher Exact||||
1608465|NCT02604212|2954257|Superiority|||||||0.0699|||||||Fisher Exact||||
1608466|NCT02604212|2954258|Superiority|||||||0.0769|||||||Fisher Exact||||
1608467|NCT02604212|2954258|Superiority|||||||0.0508|||||||Fisher Exact||||
1608468|NCT02604212|2954258|Superiority|||||||0.4615|||||||Fisher Exact||||
1608469|NCT02604212|2954259|Superiority|||||||0.0294|||||||Fisher Exact||||
1608470|NCT02604212|2954259|Superiority|||||||0.0229|||||||Fisher Exact||||
1608471|NCT02604212|2954259|Superiority|||||||0.175|||||||Fisher Exact||||
1608472|NCT02604212|2954260|Superiority|||||||0.2105|||||||Fisher Exact||||
1608473|NCT02604212|2954260|Superiority|||||||0.0684|||||||Fisher Exact||||
1608474|NCT02604212|2954260|Superiority|||||||0.0625|||||||Fisher Exact||||
1608475|NCT02604212|2954261|Superiority|||||||0.1409|||||||Fisher Exact||||
1608476|NCT02604212|2954261|Superiority|||||||0.2217|||||||Fisher Exact||||
1608477|NCT02604212|2954261|Superiority|||||||0.0824|||||||Fisher Exact||||
1608478|NCT02604212|2954262|Superiority|||||||1|||||||Fisher Exact||||
1608479|NCT02604212|2954262|Superiority|||||||0.1409|||||||Fisher Exact||||
1608480|NCT02604212|2954262|Superiority|||||||0.0325|||||||Fisher Exact||||
1608481|NCT02604212|2954263|Superiority|||||||0.7214|||||||Fisher Exact||||
1608482|NCT02604212|2954263|Superiority|||||||0.6285|||||||Fisher Exact||||
1608483|NCT02604212|2954263|Superiority|||||||0.0867|||||||Fisher Exact||||
1608484|NCT02604212|2954264|Superiority||LS Mean Difference|-0.366|Standard Error of the Mean|0.085|<|0.0001|2-Sided|95.0|-0.535|-0.197|||MMRM|||Day 99|
1608485|NCT02604212|2954264|Superiority||LS Mean Difference|-0.516|Standard Error of the Mean|0.097|<|0.0001|2-Sided|95.0|-0.708|-0.325|||MMRM|||Day 99|
1608486|NCT02604212|2954264|Superiority||LS Mean Difference|-0.151|Standard Error of the Mean|0.096|<|0.1198|2-Sided|95.0|-0.341|0.04|||MMRM|||Day 99|
1608487|NCT02604212|2954264|Superiority||LS Mean Difference|-0.318|Standard Error of the Mean|0.082|<|0.0002|2-Sided|95.0|-0.481|-0.156|||MMRM|||Day 85|
1608488|NCT02604212|2954264|Superiority||LS Mean Difference|-0.404|Standard Error of the Mean|0.094|<|0.0001|2-Sided|95.0|-0.59|-0.219|||MMRM|||Day 85|
1608489|NCT02604212|2954264|Superiority||LS Mean Difference|-0.086|Standard Error of the Mean|0.092|<|0.351|2-Sided|95.0|-0.268|0.096|||MMRM|||Day 85|
1608490|NCT02604212|2954264|Superiority||LS Mean Difference|-0.257|Standard Error of the Mean|0.079|<|0.0015|2-Sided|95.0|-0.413|-0.1|||MMRM|||Day 71|
1608491|NCT02604212|2954264|Superiority||LS Mean Difference|-0.441|Standard Error of the Mean|0.091|<|0.0001|2-Sided|95.0|-0.62|-0.261|||MMRM|||Day 71|
1608492|NCT02604212|2954264|Superiority||LS Mean Difference|-0.184|Standard Error of the Mean|0.089|<|0.0415|2-Sided|95.0|-0.361|-0.007|||MMRM|||Day 71|
1608493|NCT02604212|2954264|Superiority||LS Mean Difference|-0.172|Standard Error of the Mean|0.078|<|0.0298|2-Sided|95.0|-0.326|-0.017|||MMRM|||Day 57|
1608494|NCT02604212|2954264|Superiority||LS Mean Difference|-0.322|Standard Error of the Mean|0.088|<|0.0004|2-Sided|95.0|-0.497|-0.147|||MMRM|||Day 57|
1608495|NCT02604212|2954264|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.088|<|0.0889|2-Sided|95.0|-0.324|0.023|||MMRM|||Day 57|
1608496|NCT02604212|2954264|Superiority||LS Mean Difference|-0.108|Standard Error of the Mean|0.078|<|0.1655|2-Sided|95.0|-0.262|0.045|||MMRM|||Day 29|
1608497|NCT02604212|2954264|Superiority||LS Mean Difference|-0.319|Standard Error of the Mean|0.086|<|0.0003|2-Sided|95.0|-0.489|-0.149|||MMRM|||Day 43|
1608498|NCT02604212|2954264|Superiority||LS Mean Difference|-0.211|Standard Error of the Mean|0.085|<|0.0149|2-Sided|95.0|-0.38|-0.042|||MMRM|||Day 43|
1608499|NCT02604212|2954264|Superiority||LS Mean Difference|-0.089|Standard Error of the Mean|0.077|<|0.2494|2-Sided|95.0|-0.242|0.063|||MMRM|||Day 29|
1608500|NCT02604212|2954264|Superiority||LS Mean Difference|-0.174|Standard Error of the Mean|0.084|<|0.0401|2-Sided|95.0|-0.34|-0.008|||MMRM|||Day 29|
1608501|NCT02604212|2954264|Superiority||LS Mean Difference|-0.085|Standard Error of the Mean|0.083|<|0.3104|2-Sided|95.0|-0.249|0.08|||MMRM|||Day 29|
1608502|NCT02604212|2954264|Superiority||LS Mean Difference|-0.039|Standard Error of the Mean|0.077|<|0.6136|2-Sided|95.0|-0.192|0.113|||MMRM|||Day 15|
1608503|NCT02604212|2954264|Superiority||LS Mean Difference|-0.247|Standard Error of the Mean|0.084|<|0.0036|2-Sided|95.0|-0.412|-0.082|||MMRM|||Day 15|
1608504|NCT02604212|2954264|Superiority||LS Mean Difference|-0.208|Standard Error of the Mean|0.083|<|0.0131|2-Sided|95.0|-0.372|-0.044|||MMRM|||Day 15|
1608505|NCT02604212|2954265|Superiority||LS Mean Difference|-0.396|Standard Error of the Mean|0.088|<|0.0001|2-Sided|95.0|-0.569|-0.223|||MMRM||||
1608506|NCT02604212|2954265|Superiority||LS Mean Difference|-0.438|Standard Error of the Mean|0.101|<|0.0001|2-Sided|95.0|-0.638|-0.237|||MMRM||||
1608507|NCT02604212|2954265|Superiority||LS Mean Difference|-0.042|Standard Error of the Mean|0.102|<|0.6815|2-Sided|95.0|-0.243|0.159|||MMRM||||
1608508|NCT02604199|2954275|Superiority||LS Mean|-0.223|Standard Error of the Mean|0.053||0.0001|2-Sided|95.0|-0.329|-0.117||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99|
1608509|NCT02604199|2954275|Superiority||LS Mean|-0.355|Standard Error of the Mean|0.051|<|0.0001|2-Sided|95.0|-0.458|-0.252||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99|
1608510|NCT02604199|2954275|Superiority||LS Mean|-0.132|Standard Error of the Mean|0.052|<|0.0138|2-Sided|95.0|-0.236|-0.028||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 99|
1608511|NCT02604199|2954275|Superiority||LS Mean|-0.239|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.34|-0.137||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85|
1608512|NCT02604199|2954275|Superiority||LS Mean|-0.335|Standard Error of the Mean|0.049|<|0.0001|2-Sided|95.0|-0.433|-0.236||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85|
1608513|NCT02604199|2954275|Superiority||LS Mean|-0.096|Standard Error of the Mean|0.05|<|0.0589|2-Sided|95.0|-0.195|0.004||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 85|
1608514|NCT02604199|2954275|Superiority||LS Mean|-0.206|Standard Error of the Mean|0.049|<|0.0001|2-Sided|95.0|-0.304|-0.108||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71|
1608515|NCT02604199|2954275|Superiority||LS Mean|-0.338|Standard Error of the Mean|0.047|<|0.0001|2-Sided|95.0|-0.433|-0.243||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71|
1608516|NCT02604199|2954275|Superiority||LS Mean|-0.132|Standard Error of the Mean|0.048|<|0.0084|2-Sided|95.0|-0.228|-0.035||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 71|
1608517|NCT02604199|2954275|Superiority||LS Mean|-0.181|Standard Error of the Mean|0.04|<|0.0001|2-Sided|95.0|-0.261|-0.1||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57|
1608518|NCT02604199|2954275|Superiority||LS Mean|-0.298|Standard Error of the Mean|0.039|<|0.0001|2-Sided|95.0|-0.376|-0.221||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57|
1608519|NCT02604199|2954275|Superiority||LS Mean|-0.118|Standard Error of the Mean|0.039|<|0.0043|2-Sided|95.0|-0.197|-0.039||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 57|
1608520|NCT02604199|2954275|Superiority||LS Mean|-0.122|Standard Error of the Mean|0.043|<|0.0072|2-Sided|95.0|-0.209|-0.035||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43|
1608521|NCT02604199|2954275|Superiority||LS Mean|-0.265|Standard Error of the Mean|0.042|<|0.0001|2-Sided|95.0|-0.349|-0.18||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43|
1608522|NCT02604199|2954275|Superiority||LS Mean|-0.143|Standard Error of the Mean|0.043|<|0.0017|2-Sided|95.0|-0.229|-0.057||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 43|
1608523|NCT02604199|2954275|Superiority||LS Mean|-0.109|Standard Error of the Mean|0.041|<|0.0099|2-Sided|95.0|-0.191|-0.027||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29|
1608524|NCT02604199|2954275|Superiority||LS Mean|-0.179|Standard Error of the Mean|0.04|<|0.0001|2-Sided|95.0|-0.259|-0.1||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29|
1608525|NCT02604199|2954275|Superiority||LS Mean|-0.07|Standard Error of the Mean|0.04|<|0.0875|2-Sided|95.0|-0.151|0.011||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 29|
1608526|NCT02604199|2954275|Superiority||LS Mean|-0.087|Standard Error of the Mean|0.047|<|0.067|2-Sided|95.0|-0.181|0.006||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15|
1608527|NCT02604199|2954275|Superiority||LS Mean|-0.176|Standard Error of the Mean|0.045|<|0.003|2-Sided|95.0|-0.267|-0.085||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15|
1608528|NCT02604199|2954275|Superiority||LS Mean|-0.089|Standard Error of the Mean|0.046|<|0.0583|2-Sided|95.0|-0.181|0.003||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM|||Day 15|
1608529|NCT02604199|2954276|Superiority||LS Mean Difference|-0.223|Standard Error of the Mean|0.049|<|0.0001|2-Sided|95.0|-0.322|-0.124||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM||||
1608530|NCT02604199|2954276|Superiority||LS Mean Difference|-0.309|Standard Error of the Mean|0.048|<|0.0001|2-Sided|95.0|-0.406|-0.212||MMRM includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit. Within-subject covariance is unstructured.|MMRM||||
1608531|NCT02604199|2954276|Superiority||LS Mean Difference|-0.086|Standard Error of the Mean|0.048|<|0.081|2-Sided|95.0|-0.183|0.011||Mixed effect model repeat measurement (MMRM) includes terms of parameter baseline as continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit.|MMRM|Within-subject covariance is unstructured.|||
1608532|NCT02604017|2954293|Non-Inferiority|The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 must be above -5% to achieve noninferiority.|Difference in Percentage of Participants|-0.6|||||2-Sided|95.0|-1.8|0.6||||||Based on a 2-sided significance level of 0.05 and a -5% noninferiority margin, and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides >90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.|
1608533|NCT02604017|2954294|Non-Inferiority|The noninferiority of the rate of SVR12 for the 8-week treatment group as compared with the 12-week treatment group was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the difference in percentage of participants with SVR12 (8-week group minus 12-week group) must be above -5% to achieve noninferiority.|Difference in Percentage of Participants|0.0|||||2-Sided|95.0|-1.1|1.1||||||Based on a 2-sided significance level of 0.05 and an -5% noninferiority margin and an underlying rate of ≥97% in the 8-week arm (270 participants) and ≥97% in the 12-week arm (270 participants) provides >90% power to demonstrate noninferiority of the 8-week arm to the 12-week arm.|
1608534|NCT02604017|2954295|Non-Inferiority|The noninferiority of the rate of SVR12 for the 12-week treatment group as compared with the historical rate was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR12 must exceed 91% to achieve noninferiority.|Percentage of Participants|99.7|||||2-Sided|95.0|99.1|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of ≥97% in the 12-week arm, 270 participants provides >90% power to demonstrate noninferiority of the 12-week arm to the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegIFN/RBV (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).|
1608535|NCT02603809|2954315|Superiority||LS Mean|-5.65|Standard Error of the Mean|1.41||0.0003|2-Sided|95.0|-9.11|-2.19|||ANCOVA|with Dunnett correction.|||
1608536|NCT02603809|2954315|Superiority||LS Mean|-7.5|Standard Error of the Mean|1.41|<|0.0001|2-Sided|95.0|-10.96|-4.04|||ANCOVA|with Dunnett correction.|||
1608537|NCT02603809|2954315|Superiority||LS Mean|-5.82|Standard Error of the Mean|1.396|<|0.0001|2-Sided|95.0|-9.25|-2.4|||ANCOVA|with Dunnett correction.|||
1608538|NCT02603809|2954315|Superiority||LS Mean|-1.75|Standard Error of the Mean|1.401|<|0.5356|2-Sided|95.0|-5.19|1.69|||ANCOVA|with Dunnett correction.|||
1608539|NCT02603809|2954315|Other||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrast Tests (MCTs) had a multiplicity adjusted p-value <0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran.r-projects.org/web/packages/DoseFinding.)"|
1608540|NCT02603809|2954321|Superiority||LS Mean|-7.58|Standard Error of the Mean|0.0077||0.0077|2-Sided|95.0|-13.58|-1.59|||ANCOVA|with Dunnett correction.|||
1608541|NCT02603809|2954321|Superiority||LS Mean|-9.9|Standard Error of the Mean|2.457||0.0003|2-Sided|95.0|-15.92|-3.88|||ANCOVA|with Dunnett correction.|||
1608542|NCT02603809|2954321|Superiority||LS Mean|-7.05|Standard Error of the Mean|2.42||0.0138|2-Sided|95.0|-12.98|-1.12|||ANCOVA|with Dunnett correction.|||
1608543|NCT02603809|2954321|Superiority||LS Mean|-2.45|Standard Error of the Mean|2.445||0.7071|2-Sided|95.0|-8.44|3.54|||ANCOVA|with Dunnett correction.|||
1608544|NCT02603809|2954321|Other||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrasts Tests (MCTs) had a multiplicity adjusted p-value <0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran-rprojects.org/web/packages/DoseFinding.)"|
1610436|NCT02553746|2957977|Superiority|||||||0.498|||||||Chi-squared, Corrected||||
1608545|NCT02603809|2954322|Superiority||LS Mean|-4.95|Standard Error of the Mean|1.549||0.0057|2-Sided|95.0|-8.75|-1.15|||ANCOVA|with Dunnett correction.|||
1608546|NCT02603809|2954322|Superiority||LS Mean|-6.99|Standard Error of the Mean|1.554|<|0.0001|2-Sided|95.0|-10.8|-3.19|||ANCOVA|with Dunnett correction.|||
1608547|NCT02603809|2954322|Superiority||LS Mean|-4.93|Standard Error of the Mean|1.532|<|0.0053|2-Sided|95.0|-8.68|-1.17|||ANCOVA|with Dunnett correction.|||
1608548|NCT02603809|2954322|Superiority||LS Mean|-1.31|Standard Error of the Mean|1.548|<|0.8117|2-Sided|95.0|-5.1|2.49|||ANCOVA|with Dunnett correction.|||
1608549|NCT02603809|2954322|Other||||||<|0.001|||||||Multiple Comparison Procedure-Modeling|||"Multiple Comparison Procedure-Modeling (MCP-Mod) was used to assess a dose-response across placebo and all aprocitentan doses. The null hypothesis of no dose-response was rejected if at least one of the six Multiple Contrast Tests (MCTs) had a multiplicity adjusted p-value <0.05. The analysis was performed using the R-package DoseFinding (Bornkamp B, Pinheiro J, Bretz F. Planning and analyzing dose finding experiments. 2016. Available from: cran.r-projects.org/web/packages/DoseFinding.)"|
1608550|NCT02603393|2954377|Superiority||Mean Difference (Final Values)|0.018||||0.4107|2-Sided|95.0|-0.025|0.061||2-Sided|Mixed Model for Repeated Measures Analys||||
1608551|NCT02603393|2954378|Superiority||Mean Difference (Final Values)|0.177||||0.0641||95.0|-0.01|0.365||2-Sided|Linear Mixed Model Analysis||||
1608552|NCT02603393|2954379|Superiority||Mean Difference (Final Values)|-0.288||||0.1055||95.0|-0.638|0.061||2-Sided|Mixed Model for Repated Measures Analysi||||
1608553|NCT02603393|2954380|Superiority||Mean Difference (Final Values)|-0.241||||0.1724||95.0|-0.587|0.105|||Mixed Model for Repeated Measures Analys||||
1608554|NCT02603393|2954381|Superiority||Mean Difference (Final Values)|1.4||||0.0221|2-Sided|95.0|0.2|2.6||2-Sided|Mixed Model for Repeated measures Analys||||
1608555|NCT02603393|2954382|Superiority||Mean Difference (Final Values)|1.8||||0.0022||95.0|0.7|3.0||2-Sided|Mixed Model for Repeated Measures Analys||||
1608556|NCT02603393|2954383|Superiority||Mean Difference (Final Values)|-0.026||||0.0573||95.0|-0.053|0.001||2-Sided|Mixed Model for Repeated Measures Analys||||
1608557|NCT02603393|2954384|Superiority||Ratio of rates|1.02||||0.9665|2-Sided|95.0|0.44|2.34||2-sided|Generalized Linear Model Analysis||||
1608558|NCT02603393|2954385|Superiority||Ratio of rates|1.08||||0.5651|2-Sided|95.0|0.82|1.43||2-sided|Generalized Linear Model Analysis||||
1608559|NCT02603393|2954386|Superiority||Ratio of rates|1.08||||0.5802||95.0|0.83|1.4||2 sided|Generalized Linear Model Analysis||||
1608560|NCT02603393|2954387|Non-Inferiority|Non-inferiority will be demonstrated if the 95% confidence interval of the treatment difference lies entirely to the right of (higher than) –50 mL.|Mean Difference (Final Values)|-0.026||||0.0404||95.0|-0.053|0.001||1 sided|Mixed Model for Repeated Measures Analys||||
1608561|NCT02603211|2954388|Other||||||||||||||||||"We will obtain 20 tactile image data sets from the breast tumor patients. The tactile images will be converted to size and deformation index. Then these two parameters will be converted to the risk score. This is a small number of patients for statistically significance study. Therefore, we plan to use the Leave-One-Out-Cross-Validation (LOOCV) technique to validate the human test results to determine the performance of the device.~We obtain the Risk Score. Risk Score is a unit less numerical value, which can be used as a scale to classify the tumor as malignant and benign. Based on the calculated size of the tumor and measured deformation index, the breast tumors are classified as benign and malignant using scoring method. The risk score will range from 0 to 5, where 0 represents the benign and 5 represents the malignant tumor.~Comparing the Risk Score and the Pathology reports we obtain sensitivity, specificity and accuracy of the system."
1608562|NCT02603120|2954441|Other||Difference in least squares means|-0.143||||0.47|2-Sided|95.0|-0.534|0.248|||ANOVA||||
1608563|NCT02603120|2954443|Other||Difference in least squares means|0.276||||0.33|2-Sided|95.0|-0.275|0.827|||ANOVA||||
1608564|NCT02603120|2954445|Other||Difference in least squares means|-35.0||||0.031|2-Sided|95.0|-67.0|-3.0|||ANOVA||||
1608565|NCT02603120|2954446|Superiority|||||||0.59|||||||Fisher Exact||||
1608566|NCT02603120|2954446|Non-Inferiority|It would be concluded that B/F/TAF is noninferior to ABC/DTG/3TC if the lower bound of the 2-sided 95.002% CI of the difference between treatment groups (B/F/TAF group –ABC/DTG/3TC group) in the percentage of participants with HIV-1 RNA < 50 copies/mL is greater than −10%.|Difference in Percentages|-1.4|||||2-Sided|95.002|-5.5|2.6|||||The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.||
1608567|NCT02603120|2954447|Superiority|||||||0.62|||||||Fisher Exact||||
1608568|NCT02603120|2954447|Non-Inferiority|A sample size of 260 participants per treatment group would provide at least 90% power to detect a noninferiority margin of 4% in difference in percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48, between B/F/TAF group and ABC/DTG/3TC group. Sample size was based on assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL at Wk 48 and that the non-inferiority margin is 4%, and that the significance level of the test is at a one-sided 0.025 level.|Difference in Percentages|0.7|||||2-Sided|95.002|-1.0|2.8|||||The differences in percentages of participants between treatment groups and their 95.002% CIs were calculated based on an unconditional exact method using 2 inverted 1-sided tests.||
1608569|NCT02603107|2954448|Superiority||Difference in Least Squares Means (LSM)|25.0||||0.068|2-Sided|95.0|-2.0|52.0|||ANOVA||||
1608570|NCT02603107|2954449|Superiority|||||||0.2|||||||Fisher Exact||||
1608571|NCT02603107|2954449|Non-Inferiority|The non-inferiority of B/F/TAF would be established if the lower bound of the 2-sided 95.002% CI of the difference between the treatmnet groups (B/F/TAF group - SBR group) in the percentage of participants with HIV-1 RNA < 50 copies/mL is greater than -10%.|Difference in Percentages|3.2|||||2-Sided|95.002|-1.6|8.2|||||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.||
1608572|NCT02603107|2954450|Superiority|||||||1|||||||Fisher Exact||||
1608608|NCT02599961|2954613|Superiority||LS Mean|-82.65|Standard Error of the Mean|15.55|<|0.0001|2-Sided|95.0|-113.13|-52.17||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 10-12|
1608573|NCT02603107|2954450|Non-Inferiority|A sample size of 520 participants (260 participants per treatment group) would provide at least 90% power to establish a non-inferiority margin of 4% in the Week 48 response rate (HIV-1 RNA ≥ 50 copies/mL) between the 2 treatment groups. Sample size was based on the assumptions that both treatment groups have 2% of participants with HIV-1 RNA ≥ 50 copies/mL (based on Gilead Genvoya and Stribild studies) and that the significance level of the test is at a 1-sided 0.025 level.|Difference in Percentages|0.0|||||2-Sided|95.002|-2.5|2.5|||||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 in the B/F/TAF group was at least 4% higher than the rate in the SBR group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA ≥ 50 copies/mL in the B/F/TAF group was less than 4% higher than that in the SBR group.|
1608574|NCT02602496|2954451|Equivalence|Value at week 8 minus value at week 0||||||0.27||||||Corrected for baseline concentrations, age and gender|ANOVA||||
1608575|NCT02602496|2954452|Equivalence|Value at week 8 minus value at week 0||||||0.3173|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608576|NCT02602496|2954452|Equivalence|Value at week 8 minus value at week 0||||||0.8927|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608577|NCT02602496|2954452|Equivalence|Value at week 8 minus value at week 0||||||0.8323||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA||||
1608578|NCT02602496|2954453|Equivalence|Value at week 8 minus value at week 0||||||0.7157|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608579|NCT02602496|2954453|Equivalence|Value at week 8 minus value at week 0||||||0.4715|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608580|NCT02602496|2954453|Equivalence|Value at week 8 minus value at week 0||||||0.2252||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA||||
1608581|NCT02602496|2954454|Equivalence|Value at week 8 minus value at week 0||||||0.292|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608582|NCT02602496|2954454|Equivalence|Value at week 8 minus value at week 0||||||0.0454|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608583|NCT02602496|2954454|Equivalence|Value at week 8 minus value at week 0||||||0.9255||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA||||
1608584|NCT02602496|2954455|Equivalence|Value at week 8 minus value at week 0||||||0.0151|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608585|NCT02602496|2954455|Equivalence|Value at week 8 minus value at week 0||||||0.0083|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608586|NCT02602496|2954455|Equivalence|Value at week 8 minus value at week 0||||||0.0868||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA||||
1608587|NCT02602496|2954456|Equivalence|Value at week 8 minus value at week 0||||||0.6043|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608588|NCT02602496|2954456|Equivalence|Value at week 8 minus value at week 0||||||0.1642|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608589|NCT02602496|2954456|Equivalence|Value at week 8 minus value at week 0||||||0.9708||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA||||
1608590|NCT02602496|2954457|Equivalence|Value at week 8 minus value at week 0||||||0.0006|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608591|NCT02602496|2954457|Equivalence|Value at week 8 minus value at week 0||||||0.2276|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608592|NCT02602496|2954457|Equivalence|Value at week 8 minus value at week 0||||||0.5096||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA||||
1608593|NCT02602496|2954458|Equivalence|Value at week 8 minus value at week 0||||||0.6843|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608594|NCT02602496|2954458|Equivalence|Value at week 8 minus value at week 0||||||0.0062|||||||ANOVA|Corrected for baseline concentrations, age, gender, and body mass index|||
1608595|NCT02602496|2954458|Equivalence|Value at week 8 minus value at week 0||||||0.9942||||||Corrected for baseline concentrations, age, gender, and body mass index|ANOVA||||
1608596|NCT02601560|2954523|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1608597|NCT02601560|2954523|Superiority or Other||||||<|0.44|||||||ANCOVA||||
1608598|NCT02601560|2954523|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1608599|NCT02601560|2954523|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1608600|NCT02601560|2954523|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1608601|NCT02601560|2954523|Superiority or Other||||||<|0.095|||||||ANCOVA||||
1608602|NCT02601209|2954549|Superiority||Hazard Ratio (HR)|1.36||||0.1419|1-Sided|85.0||1.7|||Log Rank|1-sided statistical test and p-value|||
1608603|NCT02601209|2954550|Other||Maximum Tolerated Dose (mg)|30.0|||||2-Sided||||||||||
1608604|NCT02600871|2954558|Superiority|The significance of variation in proportions with treatment (Provodine®, Control) was assessed with Fisher’s Exact tests and variation in the mean with treatment was assessed with T-tests.||||||0.71|||||||Fisher Exact||||
1608605|NCT02600715|2954588|Equivalence|Test for differences in continuous variables.||||||0.94||||||Two-sided alpha of 0.05 was used to determine statistical significance.|Kruskal-Wallis||||
1608606|NCT02600351|2954605|Non-Inferiority|With a 10% non-inferiority margin, a sample size of 125 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 95% for both groups.|Difference in percentages|-11.7||||0.25|2-Sided|95.0|-32.1|8.8|||Cochran-Mantel-Haenszel||||
1608607|NCT02600351|2954605|Non-Inferiority|With a 10% non-inferiority margin, a sample size of 90 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 98% for both groups.|Difference in percentages|-18.8||||0.065|2-Sided|95.0|-40.7|3.2|||Cochran-Mantel-Haenszel||||
1608648|NCT02597920|2954715|Other||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline CDS with that of Visit 3.|
1608609|NCT02599961|2954613|Superiority||LS Mean|-52.53|Standard Error of the Mean|16.882|<|0.0019|2-Sided|95.0|-85.62|-19.45||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 7-9|
1608610|NCT02599961|2954613|Superiority||LS mean|-54.91|Standard Error of the Mean|16.097|<|0.0006|2-Sided|95.0|-86.46|-23.36||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|GEE model|||Month 4-6|
1608611|NCT02599961|2954613|Superiority||LS Mean|-82.73|Standard Error of the Mean|11.363|<|0.0001|2-Sided|95.0|-105.0|-60.46||From the GEE model which includes the reduction from baseline for each visit period as the response variable, baseline as covariates, visit period as a factor, identity link function and exchangeable within subject working correlation matrix.|generalized estimating equation (GEE)|||Month 0-3|
1608612|NCT02598934|2954641|Superiority or Other||Difference in percentage of participants|14.9||||0.01|2-Sided|95.0|3.9|25.9||P-value between Consult group and Non-consult group for items in BCS: ibandronate effective in treating osteoporosis and reduces risk of breaking bone.|Chi-squared, Corrected||||
1608613|NCT02598934|2954641|Superiority or Other||Difference in percentage of participants|16.9||||0.001|2-Sided|95.0|6.3|27.5|||Chi-squared, Corrected|P-value between Consult group and Non-consult group for items in BCS: ibandronate effective in treating osteoporosis or reduces risk of breaking bone.|||
1608614|NCT02598934|2954641|Superiority or Other||Difference in percentage of participants|14.9||||0.009|2-Sided|95.0|4.0|25.8||P-value between Consult group and Non-consult group for the item in the BCS: ibandronate reduces risk of breaking bone.|Chi-squared, Corrected||||
1608615|NCT02598934|2954641|Superiority or Other||Difference in percentage of participants|16.9||||0.002|2-Sided|95.0|6.1|27.7||P-value between Consult group and Non-consult group for the item in the BCS: ibandronate was effective in treating osteoporosis|Chi-squared, Corrected||||
1608616|NCT02598128|2954672|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|The independent variables in the mixed model analysis included fixed effect factors for treatment (placebo or RELiZORB).|||
1608617|NCT02598076|2954685|Superiority|||||||0.047|||||||t-test, 2 sided||||
1608618|NCT02598076|2954686|Superiority|||||||0.095|||||||Fisher Exact||||
1608619|NCT02598076|2954687|Superiority|||||||0.23|||||||t-test, 2 sided||||
1608620|NCT02598076|2954688|Superiority|||||||0.034|||||||t-test, 2 sided||||
1608621|NCT02598076|2954689|Superiority|||||||0.015|||||||t-test, 2 sided||||
1608622|NCT02597933|2954696|Other||Mean Difference (Final Values)|0.64|Standard Error of the Mean|0.58||0.2727|2-Sided|95.0|-0.51|1.79|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.|
1608623|NCT02597933|2954697|Other||Mean Difference (Final Values)|0.032|Standard Error of the Mean|0.034||0.3447|2-Sided|95.0|-0.035|0.099|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.|
1608624|NCT02597933|2954698|Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.06||0.5914|2-Sided|95.0|-0.16|0.09|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.|
1608625|NCT02597933|2954699|Other||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|0.76||0.5668|2-Sided|95.0|-1.94|1.06|||MMRM|||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.|
1608626|NCT02597933|2954700|Other||Odds Ratio (OR)|1.03||||0.9115|2-Sided|95.0|0.57|1.88|||Cochran-Mantel-Haenszel|||The comparison between both treatment groups was performed using a Cochran-Mantel-Haenszel test. CRISS score at Week 52 was transformed into 100 binary responder endpoints using multiple imputation. These were analyzed using a Cochran-Mantel-Haenszel test, stratified by ATA status OR and the 95% confidence interval (CI) as obtained from all 100 imputations were combined using Rubin´s rule.|Missing values were imputed using worst case, i.e. considered having disease progression.
1608627|NCT02597933|2954701|Other||Hazard Ratio (HR)|1.16||||0.7535|2-Sided|95.0|0.47|2.84|||Regression, Cox|Based on Cox’s regression model (Wald test), stratified by ATA status.|||
1608628|NCT02597933|2954702|Other||Mean Difference (Final Values)|-6.28|Standard Error of the Mean|8.39||0.4547|2-Sided|95.0|-22.77|10.21|||MMRM|The model assumed that data were missing at random & that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.|
1608629|NCT02597933|2954703|Other||Mean Difference (Final Values)|46.41|Standard Error of the Mean|19.51||0.0177|2-Sided|95.0|8.09|84.73|||MMRM|The model assumed that data were missing at random & that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by-visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.|
1608649|NCT02597920|2954715|Other||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline CDS with that of Visit 2.|
1608650|NCT02597907|2954716|Other||||||<|0.05|||||||Fisher Exact||||
1608651|NCT02597855|2954717|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney test was used for a comparison of best corrected visual acuity assessed at baseline, 3 months, and 6 months between type1 and type2.||best corrected visual acuity was compared between two groups|
1608630|NCT02597933|2954704|Other||Mean Difference (Final Values)|1.15|Standard Error of the Mean|0.54||0.0331|2-Sided|1.15|0.09|2.21|||MMRM|The model assumed that data were missing at random & that patients who dropped out would have behaved similarly to those who remained in trial.||"Based on a random coefficient regression with fixed categorical effects of treatment, ATA status, fixed continuous effects of time, baseline FVC [% pred], & including treatment−by−time and baseline−by−time interactions. Random effect was included for patient specific intercept & time.~Within−patient errors are modelled by an Unstructured variance−covariance matrix.~Inter−individual variability is modelled by a Variance−Components variance−covariance matrix."|
1608631|NCT02597933|2954705|Other||Mean Difference (Final Values)|1.69|Standard Error of the Mean|1.24||0.1711|2-Sided|95.0|-0.73|4.12|||MMRM|The MMRM model assumed that data were missing at random & that patients who dropped out would have behaved similarly to those who remained in trial.||Based on mixed model repeated measures (MMRM) approach was used, with fixed categorical effects of ATA status, visit, treatment-by visit interaction and baseline-by-visit interaction. Visit was the repeated measure. Within-patient errors were modelled by unstructured variance-covariance structure.|
1608632|NCT02597933|2954706|Other||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.37||0.5785|2-Sided|95.0|-0.94|0.53|||MMRM|||The mixed model repeated measures (MMRM) approach was used. The model assumed that data were missing at random & that patients who dropped out would have behaved similarly to those who remained in trial.|
1608633|NCT02597933|2954707|Other||Mean Difference (Final Values)|40.98||||0.0349|2-Sided|95.0|2.92|79.04|||random coefficient regression|||This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status (Positive / Negative), gender and mycophenolate mofetil /sodium background therapy use (Yes / No), fixed continuous effects of time, age , height and baseline FVC (mL), the treatment-by-time and baseline-by-time interactions. Random effects was included for patient response for both time and intercept|
1608634|NCT02597933|2954707|Other||Mean Difference (Final Values)|40.95||||0.0351|2-Sided|95.0|2.88|79.01|||random coefficient regression|||This is sensitivity analysis using the model similar to the primary analysis but including a different set of covariates: the fixed, categorical effects of treatment, ATA status, the fixed continuous effects of time, baseline FVC (mL), and the treatment-by-time and baseline-by-time interactions.Random effects was included for patient response for both time and intercept.|
1608635|NCT02597933|2954707|Other||Mean Difference (Final Values)|33.86||||0.0644|2-Sided|95.0|-2.03|69.75|||random coefficient regression|||In multiple imputation SA 3, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming a similar rate of FVC decline as in all pts in the pl. group who were included in the PA. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming a similar rate of FVC decline as in all placebo patients included in the primary analysis with the most severe declines. The imputation model was similar to the statistical model of the PA.|
1608636|NCT02597933|2954707|Other||Mean Difference (Final Values)|32.93||||0.074|2-Sided|95.0|-3.19|69.06|||random coefficient regression|||In multiple imputation SA 2, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from pl. group who prematurely disc. trial drug but had a wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with a wk 52 FVC value who prematurely disc. trial drug with most severe declines. The imputation model was similar to the statistical model of the PA|
1608637|NCT02597933|2954707|Other||Mean Difference (Final Values)|30.0||||0.1046|2-Sided|95.0|-6.22|66.22|||random coefficient regression|||In multiple imputation SA 1, missing FVC values at wk 52 in pts who were alive at wk 52 were imputed assuming similar rate of FVC decline as in pts from corresponding trt group who prematurely disc. trial drug but had wk 52 FVC value. Missing FVC values at wk 52 in pts who died before wk 52 were imputed assuming similar rate of FVC decline as in pl. pts with wk 52 FVC value who prematurely disc. trial drug with most severe declines.The imputation model was similar to statistical model of PA.|
1608638|NCT02597933|2954707|Other||Mean Difference (Final Values)|43.13||||0.0378|2-Sided|95.0|2.44|83.83|||random coefficient regression|The model assumed that data were missing at random & that patients who dropped out would have behaved similarly to those who remained in trial.||"This is a sensitivity analysis (SA) on primary endpoint including only on-trt measurements of FVC [mL]. The random coefficient model was used. The analysis included fixed, categorical effects of trt, ATA status & gender, fixed continuous effects of time & bl. FVC (mL), age, height, trt -by time & bl.-by-time interactions. Random effects included for patient response for both time & intercept.~Within−patient errors were modelled by an Unstructured variance−covariance matrix."|
1608639|NCT02597933|2954707|Other||Mean Difference (Final Values)|40.95|Standard Error of the Mean|19.38||0.035|2-Sided|95.0|2.88|79.01|||random coefficient regression||The model assumed that data were missing at random & that patients who dropped out would have behaved similarly to those who remained in trial.|The primary analysis is a restricted maximum likelihood (REML) based approach using a random slope & intercept model. The analysis included the fixed, categorical effects of treatment, ATA status & gender, fixed continuous effects of time & baseline FVC (mL), age and height as well as the treatment-by time & baseline-by-time interactions. Random effects was included for patient response for both time & intercept.Within-patient errors are modelled by an unstructured variance-covariance matrix|
1608640|NCT02597920|2954709|Other||||||<|0.0001|||||||Paired t-test|||Within group comparison of Visit 2 SDS with that of Visit 3.|
1608641|NCT02597920|2954709|Other||||||<|0.0001|||||||Paired t-test|||Within group comparison of Visit 2 CDS with that of Visit 3.|
1608642|NCT02597920|2954714|Other|||||||0.0004|||||||Propensity score matching method|||Between group comparison of Visit 3 SDS|
1608643|NCT02597920|2954714|Other|||||||0.0002|||||||Propensity score matching method|||Between group comparison of Visit 2 SDS|
1608644|NCT02597920|2954714|Other|||||||0.0002|||||||Propensity score matching method|||Between group comparison of Visit 3 CDS|
1608645|NCT02597920|2954714|Other|||||||0.0005|||||||Propensity score matching method|||Between group comparison of Visit 2 CDS|
1608646|NCT02597920|2954715|Other||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline SDS with that of Visit 3.|
1608647|NCT02597920|2954715|Other||||||<|0.0001|||||||Paired t-test|||Within group comparison of Baseline SDS with that of Visit 2.|
1608652|NCT02597855|2954718|Superiority or Other||||||<|0.05|||||||Fisher Exact|||The difference of polyp regression rate between two groups were compared.|
1608653|NCT02597582|2954719|Non-Inferiority or Equivalence|as above||||||0.037|||||||Wilcoxon (Mann-Whitney)||||
1608654|NCT02597582|2954720|Non-Inferiority or Equivalence|as above||||||0.524|||||||t-test, 2 sided||||
1608655|NCT02597582|2954722|Non-Inferiority or Equivalence|as above||||||0.06|||||||t-test, 2 sided||||
1608656|NCT02597582|2954723|Non-Inferiority or Equivalence|As above||||||0.266|||||||t-test, 2 sided||||
1608657|NCT02597582|2954724|Non-Inferiority or Equivalence|"A previous study found that the mean operation time was 165 minutes for patients undergoing LigaSure vessel sealing system-assisted total laryngectomy plus neck dissection and 195 minutes for those receiving conventional hemostasis.~With a difference in operative duration of 30 minutes between the two groups,9 the estimated sample size needed to demonstrate a two-sided significance level of 0.05 with 80% power should be at least 18 participants in each treatment arm."||||||0.022|||||||t-test, 2 sided||||
1608658|NCT02597127|2954747|Superiority|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 300 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided||||
1608659|NCT02597127|2954747|Superiority|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 200 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided||||
1608660|NCT02597127|2954747|Superiority|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 100 mg Double-Dose) Inclisiran group versus Placebo (Double-Dose).|t-test, 1 sided||||
1608661|NCT02597127|2954747|Superiority|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 500 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided||||
1608662|NCT02597127|2954747|Superiority|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 300 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided||||
1608663|NCT02597127|2954747|Superiority|Two sample t-tests were performed to test the superiority of any dosing group over placebo. A Dunnett multiple t-test procedure was applied to adjust for multiple comparisons with six different dosing regimens.|||||<|0.0001||||||This P-Value applies to the comparison of the mean percent change at Day 180 for the 200 mg (Single-Dose) Inclisiran group versus Placebo (Single-Dose).|t-test, 1 sided||||
1608664|NCT02597049|2954755|Superiority||Mean Difference (Final Values)|-0.6||||0.32|2-Sided|95.0|-1.7|0.6|||ANCOVA|||Efficacy Estimand|
1608665|NCT02597049|2954755|Superiority||Mean Difference (Final Values)|-1.3||||0.023|2-Sided|95.0|-2.4|-0.2|||ANCOVA|||Efficacy Estimand|
1608666|NCT02597049|2954755|Superiority||Mean Difference (Final Values)|-0.6||||0.273|2-Sided|95.0|-1.7|0.5|||ANCOVA|||Treatment-regimen Estimand|
1608667|NCT02597049|2954755|Superiority||Mean Difference (Final Values)|-1.2||||0.032|2-Sided|95.0|-2.3|-0.1|||ANCOVA|||Treatment-regimen Estimand|
1608668|NCT02597049|2954756|Superiority||Mean Difference (Final Values)|-16.7|||<|0.001|2-Sided|95.0|-26.0|-7.4|||Mixed Models Analysis|||2-hour postprandial after evening meal|
1608669|NCT02597049|2954756|Superiority||Mean Difference (Final Values)|-22.1|||<|0.001|2-Sided|95.0|-31.4|-12.9|||Mixed Models Analysis|||2-hour postprandial after evening meal|
1608670|NCT02597049|2954756|Superiority||Mean Difference (Final Values)|-22.5|||<|0.001|2-Sided|95.0|-30.7|-14.4|||Mixed Models Analysis|||Pre-evening meal|
1608671|NCT02597049|2954756|Superiority||Mean Difference (Final Values)|-22.7|||<|0.001|2-Sided|95.0|-30.7|-14.7|||Mixed Models Analysis|||Pre-evening meal|
1608672|NCT02597049|2954756|Superiority||Mean Difference (Final Values)|-12.8|||<|0.01|2-Sided|95.0|-22.5|-3.1|||Mixed Models Analysis|||2-hour postprandial after midday meal|
1608673|NCT02597049|2954756|Superiority||Mean Difference (Final Values)|-19.0|||<|0.001|2-Sided|95.0|-28.8|-9.3|||Mixed Models Analysis|||2-hour postprandial after midday meal|
1608674|NCT02597049|2954756|Superiority||Mean Difference (Final Values)|-14.3|||<|0.001|2-Sided|95.0|-22.5|-6.2|||Mixed Models Analysis|||Pre-midday meal|
1608675|NCT02597049|2954756|Superiority||Mean Difference (Final Values)|-18.3|||<|0.001|2-Sided|95.0|-26.4|-10.2|||Mixed Models Analysis|||Pre-midday meal|
1608676|NCT02597049|2954756|Superiority||Mean Difference (Final Values)|-21.1|||<|0.001|2-Sided|95.0|-30.3|-11.8|||Mixed Models Analysis|||2-hour postprandial|
1608677|NCT02597049|2954756|Superiority||Mean Difference (Final Values)|-24.5|||<|0.001|2-Sided|95.0|-33.8|-15.3|||Mixed Models Analysis|||2-hour postprandial|
1608678|NCT02597049|2954756|Superiority||Mean Difference (Final Values)|-15.2|||<|0.001|2-Sided|95.0|-21.2|-9.2|||Mixed Models Analysis|||Pre-morning meal|
1608679|NCT02597049|2954756|Superiority||Mean Difference (Final Values)|-19.7|||<|0.001|2-Sided|95.0|-25.7|-13.8|||Mixed Models Analysis|||Pre-morning meal.|
1608680|NCT02597049|2954757|Superiority||Mean Difference (Final Values)|-20.7|||<|0.001|2-Sided|95.0|-26.7|-14.6||Test was not controlled for type I error.|ANCOVA|||Efficacy Estimand|
1608681|NCT02597049|2954757|Superiority||Mean Difference (Final Values)|-26.6|||<|0.001|2-Sided|95.0|-32.7|-20.6||Test was not controlled for type I error.|ANCOVA|||Efficacy Estimand|
1608682|NCT02597049|2954757|Superiority||Mean Difference (Final Values)|-19.6|||<|0.001|2-Sided|95.0|-25.7|-13.5||Test was not controlled for type I error.|ANCOVA|||Treatment-regimen Estimand|
1608683|NCT02597049|2954757|Superiority||Mean Difference (Final Values)|-24.7|||<|0.001|2-Sided|95.0|-30.8|-18.6|||ANCOVA|||Treatment-regimen Estimand|
1608684|NCT02597049|2954758|Superiority||Mean Difference (Final Values)|-0.3||||0.435|2-Sided|95.0|-1.2|0.5|||Mixed Models Analysis|||Efficacy Estimand|
1608685|NCT02597049|2954758|Superiority||Mean Difference (Final Values)|-0.8||||0.059|2-Sided|95.0|-1.7|0.0|||Mixed Models Analysis|||Efficacy Estimand|
1608686|NCT02597049|2954758|Superiority||Mean Difference (Final Values)|-0.5||||0.264|2-Sided|95.0|-1.3|0.4|||Mixed Models Analysis|||Treatment-regimen Estimand|
1608687|NCT02597049|2954758|Superiority||Mean Difference (Final Values)|-0.9||||0.027|2-Sided|95.0|-1.8|-0.1|||Mixed Models Analysis|||Treatment-regimen Estimand|
1608688|NCT02597049|2954759|Superiority||||||<|0.001|||||||Regression, Logistic|||Efficacy Estimand|
1608689|NCT02597049|2954759|Superiority||||||<|0.001|||||||Regression, Logistic|||Efficacy Estimand|
1608690|NCT02597049|2954759|Superiority||||||<|0.001|||||||Regression, Logistic|||Treatment-regimen Estimand|
1608691|NCT02597049|2954759|Superiority||||||<|0.001|||||||Regression, Logistic|||Treatment-regimen Estimand|
1608692|NCT02597049|2954760|Superiority||Mean Difference (Final Values)|-0.69|||<|0.001|2-Sided|95.0|-0.86|-0.51|||Mixed Models Analysis||||
1608693|NCT02597049|2954760|Superiority||Mean Difference (Final Values)|-0.82|||<|0.001|2-Sided|95.0|-1.0|-0.64|||Mixed Models Analysis||||
1608694|NCT02597049|2954761|Superiority||Mean Difference (Final Values)|-0.66|||<|0.001|2-Sided|95.0|-0.84|-0.49|||Mixed Models Analysis||||
1608695|NCT02597049|2954761|Superiority||Mean Difference (Final Values)|-0.79|||<|0.001|2-Sided|95.0|-0.97|-0.61|||Mixed Models Analysis||||
1608696|NCT02596893|2954790|Superiority||Stratified Difference|-2.7||||0.5591|2-Sided|95.0|-12.0|6.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608697|NCT02596893|2954790|Superiority||Stratified Difference|-3.6||||0.4286|2-Sided|95.0|-12.8|5.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608698|NCT02596893|2954790|Superiority||Stratified Difference|0.5||||0.9141|2-Sided|95.0|-8.9|10.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights||
1608699|NCT02596893|2954793|Superiority||Stratified difference|-2.0||||0.2578|2-Sided|95.0|-8.7|5.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608700|NCT02596893|2954793|Superiority||Stratified difference|-2.0||||0.2221|2-Sided|95.0|-8.7|5.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608701|NCT02596893|2954793|Superiority||Stratified difference|-1.6||||0.3573|2-Sided|95.0|-8.3|5.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with CMH weights.||
1608702|NCT02596893|2954794|Superiority||Stratified difference|-3.9||||0.4383|2-Sided|95.0|-13.5|5.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.||
1608703|NCT02596893|2954794|Superiority||Stratified difference|-1.0||||0.8334|2-Sided|95.0|-10.8|8.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608704|NCT02596893|2954794|Superiority||Stratified difference|-10.6||||0.0239|2-Sided|95.0|-19.6|-1.4|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608705|NCT02596893|2954795|Superiority||Stratified difference|-1.0||||0.6123|2-Sided|95.0|-7.2|6.8|||Cochran-Mantel-Haenszel||||The weighted average of the treatment differences across the strata with the CMH weights.
1608706|NCT02596893|2954795|Superiority||Stratified difference|1.4||||0.5583|2-Sided|95.0|-5.1|7.3|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608707|NCT02596893|2954795|Superiority||Stratified difference|-0.5||||0.8031|2-Sided|95.0|-6.7|5.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608708|NCT02596893|2954796|Superiority||Stratified difference|0.0|||>|0.9999|2-Sided|95.0|-12.8|13.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608709|NCT02596893|2954796|Superiority||Stratified difference|4.7|||>|0.2823|2-Sided|95.0|-8.8|18.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608710|NCT02596893|2954796|Superiority||Unstratified CMH|-2.2|||>|0.3572|2-Sided|95.0|-11.3|7.0|||Cochran-Mantel-Haenszel|p-values were based on the unstratified CMH test when 1 and only 1 of the 2 treatment groups being compared had no subjects in a stratum.|The weighted average of the treatment differences across the strata with the CMH weights.|2-sided 95% CI were based on the unstratified Newcombe method.|
1608711|NCT02596893|2954797|Superiority||Stratified difference|-4.4||||0.2865|2-Sided|95.0|-12.6|3.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.||
1608712|NCT02596893|2954797|Superiority||Stratified difference|-3.7||||0.3784|2-Sided|95.0|-12.0|4.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.||
1608713|NCT02596893|2954797|Superiority||Stratified difference|-1.3||||0.7541|2-Sided|95.0|-9.8|7.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.||
1608714|NCT02596893|2954798|Superiority||Stratified difference|-5.8||||0.2452|2-Sided|95.0|-15.5|4.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.||
1608715|NCT02596893|2954798|Superiority||Stratified difference|-1.8||||0.716|2-Sided|95.0|-11.8|8.2|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.||
1608716|NCT02596893|2954798|Superiority||Stratified difference|-5.8||||0.2493|2-Sided|95.0|-15.5|4.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.||
1608717|NCT02596893|2954799|Superiority||Stratified difference|-9.7||||0.0741|2-Sided|95.0|-20.1|1.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the Cochran-Mantel-Haenszel (CMH) weights.||
1608718|NCT02596893|2954799|Superiority||Stratified difference|-9.9||||0.0582|2-Sided|95.0|-20.3|0.7|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608719|NCT02596893|2954799|Superiority||Stratified Difference|-11.7||||0.0299|2-Sided|95.0|-22.0|-1.1|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608720|NCT02596893|2954800|Superiority||Stratified Difference|-2.1||||0.3264|2-Sided|95.0|-9.1|4.6|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608721|NCT02596893|2954800|Superiority||Stratified Difference|-2.4||||0.2309|2-Sided|95.0|-9.4|4.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608722|NCT02596893|2954800|Superiority||Stratified Difference|-2.6||||0.1799|2-Sided|95.0|-9.5|5.0|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608723|NCT02596893|2954801|Superiority||Stratified Difference|-2.1||||0.442|2-Sided|95.0|-9.1|5.3|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608724|NCT02596893|2954801|Superiority||Slope|4.8||||0.1626|2-Sided|95.0|-3.0|11.8|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608725|NCT02596893|2954801|Superiority||Stratified Difference|-2.9||||0.2523|2-Sided|95.0|-9.7|3.9|||Cochran-Mantel-Haenszel||The weighted average of the treatment differences across the strata with the CMH weights.||
1608726|NCT02596854|2954804|Non-Inferiority|α=0.025 with a margin of Δ=0.5 were used for non-inferiority testing|Median Difference (Net)|-0.428|Standard Error of the Mean|0.3522|<|0.001|2-Sided|95.0|-0.428|-0.269||No adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)||Notably, no separate comparative statistical analysis was performed for the 1.5T and 3.0T subgroups, which were pooled for analysis. All patients underwent both synthetic MR and commercial conventional MR in a single arm.|Non-inferiority of synthetic MR versus conventional commercial MR the hypothesis can be stated as H0: S ≤ -Δ and HA: S > -Δ.|To mitigate possible bias, the hypothesis test was executed via pre-programmed SAS module, which does not show the data for individual synthetic and conventional group values. The data for these individual groups is thus not currently available as part of the study report held by the sponsor or submitted to FDA. Thus, this data cannot be presented without additional analysis (re-programming) of the original SAS used to perform the study. Data were only reported as the difference between synthetic - conventional to determine non-inferiority, and data for individual crossovers (synthetic vs. conventional) were not calculated.The raw conventional scan images and those post-processed with the research software were combined as pre-specified in the study protocol
1608727|NCT02596230|2954818|Other||Hazard Ratio (HR)|0.857||||0.69|2-Sided|95.0|0.402|1.828||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio < 1 favors Dabigatran etexilate.||
1608728|NCT02596230|2954819|Other||Hazard Ratio (HR)|0.0||||0.996|2-Sided|95.0||||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|"Hazard Ratio < 1 favors Dabigatran etexilate.~Hazard Ratio is actually <0.01~95% Confidence Interval is not calculable (NA) due to insufficient number of participants with events."||
1608729|NCT02596230|2954820|Other||Hazard Ratio (HR)|0.751||||0.542|2-Sided|95.0|0.299|1.885||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio < 1 favors Dabigatran etexilate.||
1608730|NCT02596230|2954821|Other||Hazard Ratio (HR)|0.778||||0.606|2-Sided|95.0|0.3|2.017||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio < 1 favors Dabigatran etexilate.||
1608731|NCT02596230|2954822|Other||Hazard Ratio (HR)|0.634||||0.188|2-Sided|95.0|0.322|1.249||One-side p-value|Regression, Cox|Cox-regression proportional hazards model including fixed effects for treatment.|Hazard Ratio < 1 favors Dabigatran etexilate.||
1608732|NCT02596009|2954835|Superiority or Other||Mean Difference (Final Values)|53.93|||<|0.0001|2-Sided|95.0|49.15|58.72|||paired t-test||||
1608733|NCT02596009|2954835|Superiority or Other||Mean Difference (Final Values)|26.97|||<|0.0001|2-Sided|95.0|23.7|30.24|||paired t-test||||
1608734|NCT02595970|2954841|Superiority|adjusted|Mean Difference (Net)|-21.6|Standard Error of the Mean|0.99|<|0.0001|2-Sided|95.0|-23.52|19.58|||t-test, 2 sided||||
1608735|NCT02595970|2954851|Superiority|adjusted for multiplicity using the Hochberg procedure.|Mean Difference (Net)|-22.6|Standard Error of the Mean|0.99|<|0.0001|2-Sided|95.0|-24.52|20.59|||t-test, 2 sided||||
1608736|NCT02595723|2954852|Other|||||||0.003||||||Overall group difference adjusted for prior group, time, and baseline values.|Mixed Models Analysis|Model includes prior group, time, and baseline values to control for possible effects.|||
1608737|NCT02595073|2954865|Superiority|||||||0.619|||||||ANCOVA||||
1608738|NCT02595073|2954866|Superiority|||||||0.3353|||||||z-test, 2-tailed||||
1608739|NCT02594826|2954868|Superiority|||||||0.005|||||||Regression, Linear|Controlling for: marital status, education, language spoken at home, health insurance, regular physician, language of physician, ever had Pap test.||The null hypothesis is that the two conditions would not differ in their knowledge following program participation. The study biostatistician conducted full regression models to examine change in knowledge (from pre- to post-program) within each group and across groups over time. The models controlled for relevant covariates.|
1608740|NCT02594826|2954869|Superiority or Other (legacy)||Odds Ratio (OR)|35.8|||<|0.001|2-Sided|95.0|11.1|114.9|||Mixed Models Analysis|This is the calculated p-value, which is adjusted for age, marital status, prior screening, health insurance, and having a healthcare provider.|||
1608741|NCT02592655|2954922|Superiority or Other|||||||0.5||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that using the pneumatic tourniquet is just as likely to occlude arterial flow as using two windlass tourniquets.~Participant count of 17 to accommodate for missing ultrasound data."|
1608811|NCT02592434|2954974|Superiority||Difference in percentage|-0.6||||0.9308|2-Sided|95.0|-14.03|12.84|||Normal approximation to the binomial|||Week 24|
1608742|NCT02592655|2954922|Superiority or Other|||||||0.5||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that the 10 cm wide tourniquet tape is just as likely to occlude arterial flow as using two windlass tourniquets.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."|
1608743|NCT02592655|2954922|Superiority or Other|||||||0.008||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as two windlass tourniquets.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."|
1608744|NCT02592655|2954922|Superiority or Other|||||||0.002||||||Significance thresh hold: 0.05.|McNemar|||"Null hypothesis is that one windlass tourniquet is just as likely to occlude arterial flow as the 10 cm wide tourniquet tape.~Participant count of 18 to accommodate for missing windlass tourniquet ultrasound data."|
1608745|NCT02592629|2954923|Equivalence|ANOVA|||||<|0.05|||||||ANOVA||||
1608746|NCT02592434|2954959|Superiority||LS mean difference|-0.8|Standard Error of the Mean|0.31||0.0118|2-Sided|95.0|-1.41|-0.18|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608747|NCT02592434|2954959|Superiority||LS mean difference|-0.71|Standard Error of the Mean|0.32||0.0306|2-Sided|95.0|-1.35|-0.07|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608748|NCT02592434|2954959|Superiority||LS mean difference|-0.53|Standard Error of the Mean|0.28||0.0632|2-Sided|95.0|-1.09|0.03|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608749|NCT02592434|2954959|Superiority||LS mean difference|-0.99|Standard Error of the Mean|0.37||0.0091|2-Sided|95.0|-1.73|-0.25|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608750|NCT02592434|2954959|Superiority||LS mean difference|-0.87|Standard Error of the Mean|0.31||0.0067|2-Sided|95.0|-1.5|-0.25|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608751|NCT02592434|2954959|Superiority||LS mean difference|-0.95|Standard Error of the Mean|0.31||0.0026|2-Sided|95.0|-1.56|-0.34|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608752|NCT02592434|2954959|Superiority||LS Mean Difference|-0.32|Standard Error of the Mean|0.24||0.1894|2-Sided|95.0|-0.8|0.16|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608753|NCT02592434|2954961|Superiority||LS mean difference|-0.75|Standard Error of the Mean|1.67||0.6539|2-Sided|95.0|-4.07|2.57|||MMRM|||Psychosocial Health Summary : Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608754|NCT02592434|2954961|Superiority||LS mean difference|3.48|Standard Error of the Mean|2.03||0.0902|2-Sided|95.0|-0.56|7.52|||MMRM|||Physical Health Summary: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608755|NCT02592434|2954961|Superiority||LS mean difference|2.59|Standard Error of the Mean|4.29||0.5474|2-Sided|95.0|-5.96|11.14|||MMRM|||Family Cohesion: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608756|NCT02592434|2954961|Superiority||LS mean difference|-8.6|Standard Error of the Mean|3.23||0.0095|2-Sided|95.0|-15.03|-2.17|||MMRM|||Family Activities: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608757|NCT02592434|2954961|Superiority||LS mean difference|-6.72|Standard Error of the Mean|3.96||0.0944|2-Sided|95.0|-14.62|1.18|||MMRM|||Time Impact on Parent: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608758|NCT02592434|2954961|Superiority||LS mean difference|8.97|Standard Error of the Mean|5.81||0.127|2-Sided|95.0|-2.61|20.55|||MMRM|||Emotional Impact on Parent: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608759|NCT02592434|2954961|Superiority||LS mean difference|-0.02|Standard Error of the Mean|0.13||0.8909|2-Sided|95.0|-0.28|0.25|||MMRM|||Change in Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608760|NCT02592434|2954961|Superiority||LS mean difference|1.77|Standard Error of the Mean|2.48||0.4778|2-Sided|95.0|-3.18|6.72|||MMRM|||General Health Subscale: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608761|NCT02592434|2954961|Superiority||LS mean difference|0.71|Standard Error of the Mean|4.46||0.8736|2-Sided|95.0|-8.18|9.61|||MMRM|||Self Esteem: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608762|NCT02592434|2954961|Superiority||LS mean difference|-3.47|Standard Error of the Mean|3.41||0.3114|2-Sided|95.0|-10.26|3.32|||MMRM|||Mental Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608763|NCT02592434|2954961|Superiority||LS mean difference|-3.65|Standard Error of the Mean|3.9||0.353|2-Sided|95.0|-11.43|4.13|||MMRM|||Global Behavior: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608812|NCT02592434|2954974|Superiority||Difference in percentage|-0.44||||0.9427|2-Sided|95.0|-12.34|11.47|||Normal approximation to the binomial|||Week 20|
1608764|NCT02592434|2954961|Superiority||LS mean difference|-3.43|Standard Error of the Mean|2.83||0.2291|2-Sided|95.0|-9.06|2.2|||MMRM|||Behavior: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608765|NCT02592434|2954961|Superiority||LS mean difference|8.26|Standard Error of the Mean|4.36||0.062|2-Sided|95.0|-0.43|16.94|||MMRM|||Bodily Pain: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608766|NCT02592434|2954961|Superiority||LS mean difference|7.22|Standard Error of the Mean|5.56||0.1981|2-Sided|95.0|-3.86|18.3|||MMRM|||Social Limitations: Physical Subscale: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608767|NCT02592434|2954961|Superiority||LS mean difference|5.47|Standard Error of the Mean|4.76||0.2539|2-Sided|95.0|-4.01|14.95|||MMRM|||Social Limitations: Emotional: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608768|NCT02592434|2954961|Superiority||LS mean difference|3.28|Standard Error of the Mean|4.27||0.4452|2-Sided|95.0|-5.23|11.78|||MMRM|||Physical Functioning: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608769|NCT02592434|2954961|Superiority||LS Mean Difference|3.79|Standard Error of the Mean|3.77||0.3179|2-Sided|95.0|-3.72|11.31|||MMRM|||Global Health: Analysis based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608770|NCT02592434|2954963|Superiority||LS mean difference|-0.12|Standard Error of the Mean|0.05||0.0292|2-Sided|95.0|-0.22|-0.01|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608771|NCT02592434|2954963|Superiority||LS mean difference|-0.11|Standard Error of the Mean|0.06||0.0689|2-Sided|95.0|-0.24|0.01|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608772|NCT02592434|2954963|Superiority||LS mean difference|-0.12|Standard Error of the Mean|0.06||0.0572|2-Sided|95.0|-0.24|0.0|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608773|NCT02592434|2954963|Superiority||LS mean difference|-0.09|Standard Error of the Mean|0.06||0.1061|2-Sided|95.0|-0.2|0.02|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608774|NCT02592434|2954963|Superiority||LS mean difference|-0.1|Standard Error of the Mean|0.05||0.0324|2-Sided|95.0|-0.19|-0.01|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608775|NCT02592434|2954963|Superiority||LS mean difference|-0.07|Standard Error of the Mean|0.04||0.0779|2-Sided|95.0|-0.16|0.01|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608776|NCT02592434|2954963|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|0.04||0.4777|2-Sided|95.0|-0.12|0.06|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608777|NCT02592434|2954965|Superiority||LS mean difference|-0.73|Standard Error of the Mean|0.29||0.0154|2-Sided|95.0|-1.31|-0.15|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608778|NCT02592434|2954965|Superiority||LS mean difference|-0.63|Standard Error of the Mean|0.34||0.0658|2-Sided|95.0|-1.3|0.04|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608779|NCT02592434|2954965|Superiority||LS mean difference|-0.53|Standard Error of the Mean|0.29||0.0711|2-Sided|95.0|-1.1|0.05|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608780|NCT02592434|2954965|Superiority||LS mean difference|-0.97|Standard Error of the Mean|0.32||0.0039|2-Sided|95.0|-1.62|-0.33|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608781|NCT02592434|2954965|Superiority||LS mean difference|-0.82|Standard Error of the Mean|0.32||0.0131|2-Sided|95.0|-1.47|-0.18|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608782|NCT02592434|2954965|Superiority||LS Mean difference|-0.94|Standard Error of the Mean|0.28||0.0011|2-Sided|95.0|-1.49|-0.39|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608783|NCT02592434|2954965|Superiority||LS Mean Difference|-0.42|Standard Error of the Mean|0.2||0.0398|2-Sided|95.0|-0.83|-0.02|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608784|NCT02592434|2954967|Superiority||LS Mean difference|-1.58|Standard Error of the Mean|0.43||0.0007|2-Sided|95.0|-2.44|-0.71|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608785|NCT02592434|2954967|Superiority||LS Mean difference|-1.61|Standard Error of the Mean|0.4||0.0002|2-Sided|95.0|-2.42|-0.81|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608786|NCT02592434|2954967|Superiority||LS Mean difference|-1.42|Standard Error of the Mean|0.41||0.001|2-Sided|95.0|-2.24|-0.61|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608787|NCT02592434|2954967|Superiority||LS Mean difference|-0.89|Standard Error of the Mean|0.27||0.0018|2-Sided|95.0|-1.43|-0.34|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608788|NCT02592434|2954967|Superiority||LS Mean difference|-0.8|Standard Error of the Mean|0.28||0.0065|2-Sided|95.0|-1.36|-0.23|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608789|NCT02592434|2954967|Superiority||LS Mean difference|-0.84|Standard Error of the Mean|0.32||0.0094|2-Sided|95.0|-1.47|-0.21|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608790|NCT02592434|2954967|Superiority||LS mean difference|-0.54|Standard Error of the Mean|0.25||0.0353|2-Sided|95.0|-1.04|-0.04|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608791|NCT02592434|2954969|Superiority||LS Mean difference|-0.82|Standard Error of the Mean|0.42||0.0549|2-Sided|95.0|-1.66|0.02|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608792|NCT02592434|2954969|Superiority||LS Mean difference|-1.08|Standard Error of the Mean|0.49||0.0331|2-Sided|95.0|-2.07|-0.09|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608793|NCT02592434|2954969|Superiority||LS Mean difference|-1.01|Standard Error of the Mean|0.43||0.0251|2-Sided|95.0|-1.88|-0.13|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608794|NCT02592434|2954969|Superiority||LS Mean difference|-0.79|Standard Error of the Mean|0.44||0.0751|2-Sided|95.0|-1.67|0.08|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608795|NCT02592434|2954969|Superiority||LS Mean difference|-0.95|Standard Error of the Mean|0.49||0.058|2-Sided|95.0|-1.93|0.03|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608796|NCT02592434|2954969|Superiority||LS Mean difference|-0.69|Standard Error of the Mean|0.37||0.0674|2-Sided|95.0|-1.42|0.05|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608797|NCT02592434|2954969|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.23||0.2595|2-Sided|95.0|-0.72|0.19|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608798|NCT02592434|2954971|Superiority||LS Mean difference|-2.24|Standard Error of the Mean|1.03||0.0384|2-Sided|95.0|-4.36|-0.13|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608799|NCT02592434|2954971|Superiority||LS Mean difference|-3.57|Standard Error of the Mean|1.22||0.0085|2-Sided|95.0|-6.12|-1.02|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608800|NCT02592434|2954971|Superiority||LS Mean difference|-3.98|Standard Error of the Mean|1.22||0.0041|2-Sided|95.0|-6.53|-1.43|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608801|NCT02592434|2954971|Superiority||LS Mean difference|-1.17|Standard Error of the Mean|0.63||0.0822|2-Sided|95.0|-2.5|0.17|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608802|NCT02592434|2954971|Superiority||LS Mean difference|-1.66|Standard Error of the Mean|0.83||0.0552|2-Sided|95.0|-3.37|0.04|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608803|NCT02592434|2954971|Superiority||LS Mean difference|-1.42|Standard Error of the Mean|0.96||0.1421|2-Sided|95.0|-3.32|0.48|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608804|NCT02592434|2954971|Superiority||LS Mean Difference|-0.87|Standard Error of the Mean|0.61||0.1595|2-Sided|95.0|-2.08|0.35|||MMRM|||Week 20: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608805|NCT02592434|2954973|Superiority||Difference in percentage|-0.12||||0.9719|2-Sided|95.0|-6.74|6.5|||Normal approximation to the binomial||||
1608806|NCT02592434|2954974|Superiority||Difference in percentage|9.25||||0.1787|2-Sided|95.0|-4.23|22.72|||Normal approximation to the binomial|||Week 44|
1608807|NCT02592434|2954974|Superiority||Difference in percentage|12.1||||0.0695|2-Sided|95.0|-0.97|25.17|||Normal approximation to the binomial|||Week 40|
1608808|NCT02592434|2954974|Superiority||Difference in percentage|9.25||||0.1787|2-Sided|95.0|-4.23|22.72|||Normal approximation to the binomial|||Week 36|
1608809|NCT02592434|2954974|Superiority||Difference in percentage|2.22||||0.7455|2-Sided|95.0|-11.2|15.64|||Normal approximation to the binomial|||Week 32|
1608810|NCT02592434|2954974|Superiority||Difference in percentage|0.87||||0.8945|2-Sided|95.0|-12.03|13.78|||Normal approximation to the binomial|||Week 28|
1608813|NCT02592434|2954974|Superiority||Difference in percentage|-17.42||||0.0062|2-Sided|95.0|-29.88|-4.96|||Normal approximation to the binomial|||Double Blind baseline (Week 18)|
1608814|NCT02592434|2954975|Superiority||Difference in percentage|8.06||||0.1634|2-Sided|95.0|-3.27|19.38|||Normal approximation to the binomial|||Week 44|
1608815|NCT02592434|2954975|Superiority||Difference in percentage|10.91||||0.0464|2-Sided|95.0|0.17|21.65|||Normal approximation to the binomial|||Week 40|
1608816|NCT02592434|2954975|Superiority||Difference in percentage|9.52||||0.0758|2-Sided|95.0|-0.99|20.04|||Normal approximation to the binomial|||Week 36|
1608817|NCT02592434|2954975|Superiority||Difference in percentage|5.4||||0.2435|2-Sided|95.0|-3.67|14.47|||Normal approximation to the binomial|||Week 32|
1608818|NCT02592434|2954975|Superiority||Difference in percentage|2.58||||0.5795|2-Sided|95.0|-6.54|11.7|||Normal approximation to the binomial|||Week 28|
1608819|NCT02592434|2954975|Superiority||Difference in percentage|6.79||||0.1561|2-Sided|95.0|-2.59|16.16|||Normal approximation to the binomial|||Week 24|
1608820|NCT02592434|2954975|Superiority||Difference in percentage|6.87||||0.0876|2-Sided|95.0|-1.01|14.74|||Normal approximation to the binomial|||Week 20|
1608821|NCT02592434|2954975|Superiority||Difference in percentage|-3.06||||0.5131|2-Sided|95.0|-12.21|6.1|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)|
1608822|NCT02592434|2954977|Superiority||Difference in percentage|14.37||||0.0773|2-Sided|95.0|-1.57|30.3|||Normal approximation to the binomial|||Week 44|
1608823|NCT02592434|2954977|Superiority||Difference in percentage|14.4||||0.0746|2-Sided|95.0|-1.43|30.24|||Normal approximation to the binomial|||Week 40|
1608824|NCT02592434|2954977|Superiority||Difference in percentage|14.44||||0.0716|2-Sided|95.0|-1.27|30.16|||Normal approximation to the binomial|||Week 36|
1608825|NCT02592434|2954977|Superiority||Difference in percentage|7.42||||0.3571|2-Sided|95.0|-8.37|23.21|||Normal approximation to the binomial|||Week 32|
1608826|NCT02592434|2954977|Superiority||Difference in percentage|11.51||||0.161|2-Sided|95.0|-4.58|27.6|||Normal approximation to the binomial|||Week 28|
1608827|NCT02592434|2954977|Superiority||Difference in percentage|12.94||||0.1135|2-Sided|95.0|-3.08|28.96|||Normal approximation to the binomial|||Week 24|
1608828|NCT02592434|2954977|Superiority||Difference in percentage|10.12||||0.2173|2-Sided|95.0|-5.96|26.2|||Normal approximation to the binomial|||Week 20|
1608829|NCT02592434|2954977|Superiority||Difference in percentage|1.47||||0.861|2-Sided|95.0|-14.96|17.9|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)|
1608830|NCT02592434|2954979|Superiority||LS Mean Difference|-4.41|Standard Error of the Mean|1.25||0.0018|2-Sided|95.0|-6.99|-1.82|||MMRM|||Week 44:Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608831|NCT02592434|2954979|Superiority||LS Mean Difference|-5.62|Standard Error of the Mean|1.49||0.0007|2-Sided|95.0|-8.66|-2.58|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608832|NCT02592434|2954979|Superiority||LS Mean Difference|-5.66|Standard Error of the Mean|1.52||0.0007|2-Sided|95.0|-8.74|-2.57|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608833|NCT02592434|2954979|Superiority||LS Mean Difference|-3.41|Standard Error of the Mean|1.01||0.002|2-Sided|95.0|-5.47|-1.36|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608834|NCT02592434|2954979|Superiority||LS Mean Difference|-3.58|Standard Error of the Mean|1.16||0.0038|2-Sided|95.0|-5.94|-1.23|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608835|NCT02592434|2954979|Superiority||LS Mean Difference|-3.41|Standard Error of the Mean|1.21||0.0057|2-Sided|95.0|-5.81|-1.01|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608836|NCT02592434|2954979|Superiority||LS Mean Difference|-1.83|Standard Error of the Mean|0.76||0.0172|2-Sided|95.0|-3.32|-0.33|||MMRM|||Week 20: Analysis was based on Mixed Model for Repeated Measures (MMRM) with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608837|NCT02592434|2954981|Superiority||LS mean difference|-4.36|Standard Error of the Mean|1.27||0.0027|2-Sided|95.0|-7.02|-1.71|||MMRM|||Week 44: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608838|NCT02592434|2954981|Superiority||LS mean difference|-6.26|Standard Error of the Mean|1.63||0.0006|2-Sided|95.0|-9.6|-2.92|||MMRM|||Week 40: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608839|NCT02592434|2954981|Superiority||LS mean difference|-6.21|Standard Error of the Mean|1.57||0.0005|2-Sided|95.0|-9.42|-3.0|||MMRM|||Week 36: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608840|NCT02592434|2954981|Superiority||LS mean difference|-3.3|Standard Error of the Mean|0.98||0.0022|2-Sided|95.0|-5.3|-1.29|||MMRM|||Week 32: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608841|NCT02592434|2954981|Superiority||LS mean difference|-3.85|Standard Error of the Mean|1.25||0.0039|2-Sided|95.0|-6.38|-1.32|||MMRM|||Week 28: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608881|NCT02592434|2954995|Superiority||Difference in percentage|-23.57||||0.0027|2-Sided|95.0|-38.97|-8.17|||Normal approximation to the binomial|||at Week 36|
1610437|NCT02553746|2957978|Superiority|||||||0.748|||||||Chi-squared, Corrected||||
1608842|NCT02592434|2954981|Superiority||LS mean difference|-3.64|Standard Error of the Mean|1.28||0.0054|2-Sided|95.0|-6.17|-1.1|||MMRM|||Week 24: Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608843|NCT02592434|2954981|Superiority||LS mean difference|-2.07|Standard Error of the Mean|0.78||0.0088|2-Sided|95.0|-3.6|-0.53|||MMRM|||Week 20; Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the double-blind baseline value.|
1608844|NCT02592434|2954983|Superiority||Difference in percentage|12.02||||0.0858|2-Sided|95.0|-1.69|25.74|||Normal approximation to the binomial|||Week 44|
1608845|NCT02592434|2954983|Superiority||Difference in percentage|9.17||||0.2017|2-Sided|95.0|-4.91|23.24|||Normal approximation to the binomial|||Week 40|
1608846|NCT02592434|2954983|Superiority||Difference in percentage|11.98||||0.0936|2-Sided|95.0|-2.02|25.99|||Normal approximation to the binomial|||Week 36|
1608847|NCT02592434|2954983|Superiority||Difference in percentage|6.35||||0.3782|2-Sided|95.0|-7.77|20.47|||Normal approximation to the binomial|||Week 32|
1608848|NCT02592434|2954983|Superiority||Difference in percentage|2.1||||0.7732|2-Sided|95.0|-12.2|16.41|||Normal approximation to the binomial|||Week 28|
1608849|NCT02592434|2954983|Superiority||Difference in percentage|3.49||||0.635|2-Sided|95.0|-10.93|17.91|||Normal approximation to the binomial|||Week 24|
1608850|NCT02592434|2954983|Superiority||Difference in percentage|10.63||||0.1254|2-Sided|95.0|-2.97|24.24|||Normal approximation to the binomial|||Week 20|
1608851|NCT02592434|2954983|Superiority||Difference in percentage|-16.15||||0.0207|2-Sided|95.0|-29.84|-2.46|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)|
1608852|NCT02592434|2954985|Superiority||Difference in percentage|13.29||||0.0744|2-Sided|95.0|-1.31|27.9|||Normal approximation to the binomial|||Week 44|
1608853|NCT02592434|2954985|Superiority||Difference in percentage|11.87||||0.115|2-Sided|95.0|-2.89|26.62|||Normal approximation to the binomial|||Week 40|
1608854|NCT02592434|2954985|Superiority||Difference in percentage|18.89||||0.0115|2-Sided|95.0|4.24|33.54|||Normal approximation to the binomial|||Week 36|
1608855|NCT02592434|2954985|Superiority||Difference in percentage|16.03||||0.0356|2-Sided|95.0|1.08|30.98|||Normal approximation to the binomial|||Week 32|
1608856|NCT02592434|2954985|Superiority||Difference in percentage|8.97||||0.2481|2-Sided|95.0|-6.25|24.19|||Normal approximation to the binomial|||Week 28|
1608857|NCT02592434|2954985|Superiority||Difference in percentage|8.93||||0.2557|2-Sided|95.0|-6.47|24.33|||Normal approximation to the binomial|||Week 24|
1608858|NCT02592434|2954985|Superiority||Difference in percentage|9.01||||0.24||95.0|-6.02|24.03|||Normal approximation to the binomial|||Week 20|
1608859|NCT02592434|2954985|Superiority||Difference in percentage|-5.24||||0.515|2-Sided|95.0|-21.0|10.53|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)|
1608860|NCT02592434|2954987|Superiority||Difference in percentage|19.88||||0.0149|2-Sided|95.0|3.88|35.88|||Normal approximation to the binomial|||Week 40|
1608861|NCT02592434|2954987|Superiority||Difference in percentage|19.88||||0.0149|2-Sided|95.0|3.88|35.88|||Normal approximation to the binomial|||Week 36|
1608862|NCT02592434|2954987|Superiority||Difference in percentage|18.37||||0.0258|2-Sided|95.0|2.22|34.52|||Normal approximation to the binomial|||Week 32|
1608863|NCT02592434|2954987|Superiority||Difference in percentage|7.02||||0.4026|2-Sided|95.0|-9.38|23.43|||Normal approximation to the binomial|||Week 28|
1608864|NCT02592434|2954987|Superiority||Difference in percentage|14.05||||0.0908|2-Sided|95.0|-2.23|30.33|||Normal approximation to the binomial|||Week 24|
1608865|NCT02592434|2954987|Superiority||Difference in percentage|2.62||||0.7525|2-Sided|95.0|-13.66|18.9|||Normal approximation to the binomial|||Week 20|
1608866|NCT02592434|2954987|Superiority||Difference in percentage|3.77||||0.6348|2-Sided|95.0|-11.79|19.33|||Normal approximation to the binomial|||Double Blind Baseline (Week 18)|
1608867|NCT02592434|2954989|Superiority||Difference in percentage|22.34||||0.0058|2-Sided|95.0|6.46|38.22|||Normal approximation for binomial|||Week 40|
1608868|NCT02592434|2954989|Superiority||Difference in percentage|20.91||||0.0099|2-Sided|95.0|5.01|36.81|||Normal approximation for binomial|||Week 36|
1608869|NCT02592434|2954989|Superiority||Difference in percentage|25.16||||0.0018|2-Sided|95.0|9.39|40.93|||Normal approximation for binomial|||Week 32|
1608870|NCT02592434|2954989|Superiority||Difference in percentage|17.9||||0.0233|2-Sided|95.0|2.44|33.36|||Normal approximation for binomial|||Week 28|
1608871|NCT02592434|2954989|Superiority||Difference in percentage|21.98||||0.0034|2-Sided|95.0|7.26|36.71|||Normal approximation for binomial|||Week 24|
1608872|NCT02592434|2954989|Superiority||Difference in percentage|7.66||||0.2682|2-Sided|95.0|-5.9|21.21|||Normal approximation for binomial|||Week 20|
1608873|NCT02592434|2954989|Superiority||Difference in percentage|-1.15||||0.8119|2-Sided|95.0|-10.63|8.33|||Normal approximation for binomial|||Double Blind Baseline (Week 18)|
1608874|NCT02592434|2954991|Superiority||Difference in percentage|23.69||||0.0031|2-Sided|95.0|7.97|39.41|||Normal approximation to the binomial|||at Week 40|
1608875|NCT02592434|2954991|Superiority||Difference in percentage|25.04||||0.0016|2-Sided|95.0|9.52|40.56|||Normal approximation to the binomial|||at Week 36|
1608876|NCT02592434|2954991|Superiority||Difference in percentage|23.53||||0.0025|2-Sided|95.0|8.27|38.8|||Normal approximation to the binomial|||at Week 32|
1608877|NCT02592434|2954991|Superiority||Difference in percentage|19.13||||0.0103|2-Sided|95.0|4.51|33.74|||Normal approximation to the binomial|||at Week 28|
1608878|NCT02592434|2954991|Superiority||Difference in percentage|17.54||||0.0108|2-Sided|95.0|4.05|31.03|||Normal approximation to the binomial|||at Week 24|
1608879|NCT02592434|2954991|Superiority||Difference in percentage|6.03||||0.301|2-Sided|95.0|-5.4|17.46|||Normal approximation to the binomial|||at Week 20|
1608880|NCT02592434|2954995|Superiority||Difference in percentage|-25.08||||0.0016|2-Sided|95.0|-40.69|-9.47|||Normal approximation to the binomial|||at Week 40|
1608882|NCT02592434|2954995|Superiority||Difference in percentage|-22.1||||0.0045|2-Sided|95.0|-37.35|-6.86|||Normal approximation to the binomial|||at Week 32|
1608883|NCT02592434|2954995|Superiority||Difference in percentage|-19.09||||0.0093|2-Sided|95.0|-33.48|-4.7|||Normal approximation to the binomial|||at Week 28|
1608884|NCT02592434|2954995|Superiority||Difference in percentage|-18.93||||0.0052|2-Sided|95.0|-32.22|-5.64|||Normal approximation to the binomial|||at Week 24|
1608885|NCT02592434|2954995|Superiority||Difference in percentage|-1.71||||0.741|2-Sided|95.0|-11.82|8.41|||Normal approximation to the binomial|||at Week 20|
1608886|NCT02592434|2954997|Superiority||Ls mean difference|-0.12|Standard Error of the Mean|0.05||0.0292|2-Sided|95.0|-0.22|-0.01||Threshold for significance at 0.05 level.|Mixed Model for Repeated Measures (MMRM)|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance. Analysis was based on MMRM with fixed effects of treatment, visit, JIA category, open-label baseline CRP, treatment-by-visit interaction, and the Double-Blind baseline value.|
1608887|NCT02592434|2954998|Superiority||Difference in percentage|17.02||||0.0387|2-Sided|95.0|0.88|33.17||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.|
1608888|NCT02592434|2954999|Superiority||Difference in percentage|23.69||||0.0031|2-Sided|95.0|7.97|39.41||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.|
1608889|NCT02592434|2955000|Superiority||Difference in percentage|19.52||||0.0166|2-Sided|95.0|3.55|35.5||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.|
1608890|NCT02592434|2955001|Superiority||Difference in percentage|-23.69||||0.0031|2-Sided|95.0|-39.41|-7.97||Threshold for significance at 0.05 level.|Normal approximation to the binomial|||In order to preserve type I error, each endpoint assessed sequentially using gate-keeping or step-down approach where statistical significance was claimed for the second endpoint only if the first endpoint in the sequence meets the requirements for significance.|
1608891|NCT02591056|2955024|Superiority or Other (legacy)||||||<|0.0001|||||||t-test, 2 sided|t=+7.45; df=26|||
1608892|NCT02590939|2955025|Superiority|||||||0.062||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)||||
1608893|NCT02590939|2955026|Superiority|||||||0.028||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)||||
1608894|NCT02590939|2955027|Superiority|||||||0.037||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)||||
1608895|NCT02590939|2955028|Superiority|||||||1||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)||||
1608896|NCT02590939|2955029|Superiority|||||||0.026||||||Statistical significance threshold set to 0.05|Wilcoxon (Mann-Whitney)||||
1608897|NCT02590939|2955030|Superiority|||||||0.666||||||Statistical significance threshold set to 0.05|Fisher Exact||||
1608898|NCT02590939|2955031|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1608899|NCT02590939|2955032|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1608900|NCT02590562|2955043|Superiority or Other|||||||0.0108|||||||F test||||
1608901|NCT02590562|2955044|Superiority or Other||||||<|0.0001|||||||F test||||
1608902|NCT02590432|2955088|Superiority||Hazard Ratio (HR)|0.76||||0.4518|2-Sided|95.0|0.39|1.47|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 145 μg|
1608903|NCT02590432|2955088|Superiority||Hazard Ratio (HR)|0.27||||0.0234|2-Sided|95.0|0.08|0.87|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 290 μg|
1608904|NCT02590432|2955088|Superiority||Hazard Ratio (HR)|0.92||||0.9519|2-Sided|95.0|0.39|2.18|||Log-Rank Test|||LINZESS® 145 μg vs LINZESS® 290 μg|
1608905|NCT02590432|2955089|Superiority||Hazard Ratio (HR)|0.79||||0.5149|2-Sided|95.0|0.41|1.5|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 145 μg|
1608906|NCT02590432|2955089|Superiority||Hazard Ratio (HR)|0.31||||0.0247|2-Sided|95.0|0.11|0.89|||Log-Rank Test|||LINZESS® 72 μg vs LINZESS® 290 μg|
1608907|NCT02590432|2955089|Superiority||Hazard Ratio (HR)|0.96||||0.993|2-Sided|95.0|0.42|2.19|||Log-Rank Test|||LINZESS® 145 μg vs LINZESS® 290 μg|
1608908|NCT02590432|2955091|Superiority||Odds Ratio (OR)|0.7||||0.7871|2-Sided|95.0|0.3|2.2|||Fisher’s Exact Test|||LINZESS® 72 μg vs LINZESS® 145 μg|
1608909|NCT02590432|2955091|Superiority||Odds Ratio (OR)|0.2||||0.0799|2-Sided|95.0|0.1|1.0|||Fisher’s Exact Test|||LINZESS® 72 μg vs LINZESS® 290 μg|
1608910|NCT02590432|2955091|Superiority||Odds Ratio (OR)|1.3||||1|2-Sided|95.0|0.3|5.1|||Fisher’s Exact Test|||LINZESS® 145 μg vs LINZESS® 290 μg|
1608911|NCT02590432|2955092|Superiority||Odds Ratio (OR)|0.9||||1|2-Sided|95.0|0.3|2.5|||Fisher’s Exact Test|||LINZESS® 72 μg vs LINZESS® 145 μg|
1608912|NCT02590432|2955092|Superiority||Odds Ratio (OR)|0.2||||0.0844|2-Sided|95.0|0.1|1.1|||Fisher’s Exact Test|||LINZESS® 72 μg vs LINZESS® 290 μg|
1608913|NCT02590432|2955092|Superiority||Odds Ratio (OR)|1.3||||1|2-Sided|95.0|0.3|5.5|||Fisher’s Exact Test|||LINZESS® 145 μg versus (vs) LINZESS® 290 μg|
1608914|NCT02590406|2955100|Superiority or Other (legacy)|||||||0.03|||||||ANOVA||||
1608915|NCT02590406|2955101|Superiority or Other (legacy)|||||||0.9|||||||ANOVA||||
1608916|NCT02590406|2955102|Superiority or Other (legacy)|||||||0.0003|||||||ANOVA||||
1608917|NCT02590406|2955103|Superiority or Other (legacy)||||||<|0.0001|||||||ANOVA||||
1609031|NCT02584855|2955441|Superiority||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and conventional disease-modifying antirheumatic drug (cDMARD) use at the time of double blind randomization.|
1608918|NCT02590406|2955104|Superiority or Other (legacy)|||||||0.005|||||||ANOVA|||We calculated our sample size using data from EPO2: PV study (Couture: simultaneous submitted manuscript), where we found a difference in the FRC of 21% between reverse Trendelenburg with non-invasive positive pressure ventilation and beach chair position without positive pressure ventilation. Assuming there would be a difference of 21% in the apnea time, with a type I error of 5% and power of 80%, a total of 17 patients by group was needed.|
1608919|NCT02589808|2955126|Other|||||||0.0005|||||||Kappa||||
1608920|NCT02589665|2955127|Superiority||Odds Ratio (OR)|0.71||||0.428|2-Sided|95.0|0.31|1.65|||Regression, Logistic||||
1608921|NCT02589665|2955128|Superiority||Odds Ratio (OR)|4.62||||0.012|2-Sided|95.0|1.41|15.14|||Regression, Logistic||||
1608922|NCT02589665|2955128|Superiority||Odds Ratio (OR)|7.7|||<|0.001|2-Sided|95.0|2.37|25.0|||Regression, Logistic||||
1608923|NCT02589665|2955128|Superiority||Odds Ratio (OR)|2.25|||<|0.215|2-Sided|95.0|0.63|8.07|||Regression, Logistic||||
1608924|NCT02589665|2955129|Superiority||Odds Ratio (OR)|0.48||||0.131|2-Sided|95.0|0.19|1.24|||Regression, Logistic||||
1608925|NCT02589665|2955130|Superiority||Odds Ratio (OR)|2.27||||0.054|2-Sided|95.0|0.98|5.22|||Regression, Logistic||||
1608926|NCT02589665|2955130|Superiority||Odds Ratio (OR)|6.54|||<|0.001|2-Sided|95.0|2.81|15.2|||Regression, Logistic||||
1608927|NCT02589665|2955130|Superiority||Odds Ratio (OR)|3.61|||<|0.003|2-Sided|95.0|1.57|8.31|||Regression, Logistic||||
1608928|NCT02589665|2955133|Superiority||Mean Difference (Final Values)|-0.59|||||2-Sided|95.0|-1.07|-0.11|||||||
1608929|NCT02589665|2955133|Superiority||Mean Difference (Final Values)|-1.06|||||2-Sided|95.0|-1.54|-0.59|||||||
1608930|NCT02589665|2955133|Superiority||Mean Difference (Final Values)|-0.9|||||2-Sided|95.0|-1.39|-0.41|||||||
1608931|NCT02589665|2955135|Superiority||Mean Difference (Final Values)|10.7|||||2-Sided|95.0|-1.0|22.5|||||||
1608932|NCT02589665|2955135|Superiority||Mean Difference (Final Values)|20.5|||||2-Sided|95.0|8.7|32.3|||||||
1608933|NCT02589665|2955135|Superiority||Mean Difference (Final Values)|22.9|||||2-Sided|95.0|11.0|34.9|||||||
1608934|NCT02589665|2955136|Superiority||Odds Ratio (OR)|2.29|||||2-Sided|95.0|0.8|6.55|||||||
1608935|NCT02589665|2955137|Superiority|||||||0.56|||||||Mantel Haenszel||||
1608936|NCT02589665|2955137|Superiority|||||||0.553|||||||Mantel Haenszel||||
1608937|NCT02589665|2955137|Superiority|||||||0.986|||||||Mantel Haenszel||||
1608938|NCT02589665|2955138|Superiority||Odds Ratio (OR)|2.78|||||2-Sided|95.0|1.23|6.29|||||||
1608939|NCT02589665|2955138|Superiority||Odds Ratio (OR)|6.78|||||2-Sided|95.0|2.94|15.63|||||||
1608940|NCT02589665|2955138|Superiority||Odds Ratio (OR)|3.95|||||2-Sided|95.0|1.73|8.98|||||||
1608941|NCT02589665|2955139|Superiority||Odds Ratio (OR)|3.61|||||2-Sided|95.0|0.92|14.17|||||||
1608942|NCT02589665|2955139|Superiority||Odds Ratio (OR)|7.22|||||2-Sided|95.0|1.88|27.65|||||||
1608943|NCT02589665|2955139|Superiority||Odds Ratio (OR)|2.93|||||2-Sided|95.0|0.7|12.27|||||||
1608944|NCT02589639|2955141|Superiority|The superiority of empagliflozin 25 mg against placebo was tested for change from baseline in HbA1c after 16 weeks of treatment at the level of α=0.05 (2-sided)|Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-1.18|-0.82|||ANCOVA|Analysis of Covariance (ANCOVA) comparing the change from baseline in HbA1c after 16 weeks of treatment|Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo)|The statistical model was: Change from baseline in HbA1c after 16 weeks = overall mean + baseline HbA1c + treatment + baseline renal function + type of insulin therapies + random error|
1608945|NCT02589639|2955141|Superiority|The superiority of empagliflozin 10 mg against placebo was tested for change from baseline in HbA1c after 16 weeks of treatment at the level of α=0.05 (2-sided)|Mean Difference (Final Values)|-0.92|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-1.11|-0.73|||ANCOVA|Analysis of Covariance (ANCOVA) comparing the change from baseline in HbA1c after 16 weeks of treatment||"The statistical model was:~Change from baseline in HbA1c after 16 weeks = overall mean + baseline HbA1c + treatment + baseline renal function + type of insulin therapies + random error"|Adjusted Mean Difference calculated as (Empagliflozin 10 mg - Placebo)
1608946|NCT02588599|2955177|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|t=8.0; df=53|||
1608947|NCT02588261|2955197|Superiority||Hazard Ratio (HR)|1.298||||0.78|2-Sided|95.0|0.661|2.548|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR < 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.|
1608948|NCT02588261|2955198|Superiority|||||||0.839|||||||Cochran-Mantel-Haenszel|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran-Mantel-Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.|
1608949|NCT02588261|2955199|Superiority||Hazard Ratio (HR)|1.674||||0.998|2-Sided|95.0|1.165|2.406|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR < 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.|
1608950|NCT02588261|2955200|Superiority|||||||1|||||||Cochran-Mantel-Haenszel|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using stratified Cochran–Mantel–Haenszel (CMH) test, stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025.|
1609032|NCT02584790|2955443|Other|||||||0.004|||||||Chi-squared|||2x2 table of: Row: 1. NBI suspicious pattern 2. NBI non-suspicious pattern Category: 1. with residual disease 2. without residual disease|
1608951|NCT02588261|2955202|Superiority||Hazard Ratio (HR)|1.611||||0.992|2-Sided|95.0|1.086|2.391|||Log Rank|||Comparison between ASP8273 and Erlotinib or Gefitinib treatment groups was performed using log-rank test stratified by ECOG (0 and 1 vs 2), EGFR mutation type (exon 19 deletion or exon 21 L858R) and TKI chosen by the site (erlotinib or gefitinib) before randomization. Comparison was tested at 1-sided significance level of 0.025. Hazard ratio based on Cox proportional hazards model. Assuming proportional hazards, HR < 1 indicated a reduction in hazard rate in favor of ASP8273 treatment group.|
1608952|NCT02587117|2955250|Superiority or Other|||||||0.224|||||||Mann Whitney test||||
1608953|NCT02587117|2955251|Superiority or Other|||||||0.004|||||||Mann Whitney test||||
1608954|NCT02587065|2955262|Other||Spearman's correlation coefficient|-0.85||||0.56|2-Sided|95.0|-3.72|2.02|||Mixed-effects REML regression|||Adjusted change of convenience satisfaction domain of TSQM-9.|
1608955|NCT02586896|2955268|Superiority|||||||0.54|||||||ANOVA||||
1608956|NCT02586896|2955269|Superiority|||||||0.09|||||||ANOVA||||
1608957|NCT02586896|2955270|Superiority|||||||0.91|||||||ANOVA||||
1608958|NCT02586896|2955272|Superiority|||||||0.29|||||||ANOVA||||
1608959|NCT02586805|2955274|Other||% change in mean rate (vs placebo)|-89.008|||<|0.001|2-Sided|95.0|-94.325|-78.707||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% * (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
1608960|NCT02586805|2955274|Other||% change in mean rate (vs placebo)|-75.377|||<|0.001|2-Sided|95.0|-84.115|-61.833||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% * (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
1608961|NCT02586805|2955274|Other||% change in mean rate (vs placebo)|-77.622|||<|0.001|2-Sided|95.0|-86.253|-63.572||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% * (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
1608962|NCT02586805|2955275|Other||% change in mean rate (vs placebo)|-83.394|||<|0.001|2-Sided|95.0|-91.618|-67.099||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
1608963|NCT02586805|2955275|Other||% change in mean rate (vs placebo)|-73.285|||<|0.001|2-Sided|95.0|-84.316|-54.496||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
1608964|NCT02586805|2955275|Other||% change in mean rate (vs placebo)|-70.497|||<|0.001|2-Sided|95.0|-82.696|-49.699||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
1608965|NCT02586805|2955276|Other||% change in mean rate (vs placebo)|-87.299|||<|0.001|2-Sided|95.0|-93.494|-75.204||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
1608966|NCT02586805|2955276|Other||% change in mean rate (vs placebo)|-74.169|||<|0.001|2-Sided|95.0|-83.733|-58.983||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
1608967|NCT02586805|2955276|Other||% change in mean rate (vs placebo)|-80.842|||<|0.001|2-Sided|95.0|-89.169|-66.114||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% * (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
1608987|NCT02585895|2955348|Superiority or Other||Treatment Difference|-52.74|Standard Error of the Mean|5.64|<|0.0001|2-Sided|95.0|-64.18|-41.3|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.|Treatment difference used apheresis as the reference.||
1608968|NCT02586805|2955277|Other||% change in mean rate (vs placebo)|-86.921|||<|0.001|2-Sided|95.0|-92.828|-76.15||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
1608969|NCT02586805|2955277|Other||% change in mean rate (vs placebo)|-73.271|||<|0.001|2-Sided|95.0|-82.379|-59.456||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% * (estimated mean rate ratio - 1)||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
1608970|NCT02586805|2955277|Other||% change in mean rate (vs placebo)|-75.609|||<|0.001|2-Sided|95.0|-84.65|-61.243||p-values are adjusted for multiple testing.|Chi-squared||% change in mean rate corresponds to 100% * (estimated mean rate ratio - 1).||Results from Poisson regression model with fixed effects for treatment group (categorical) and normalized baseline attack rate (continuous), and logarithm of time in days each participant was observed during treatment period as offset variable in model. Pearson chi-square scaling of standards errors was employed to account for potential overdispersion. Mean estimates are Least Squares (LS) means.
1608971|NCT02586415|2955294|Superiority||Odds Ratio (OR)|2.77|||<|0.001|2-Sided|95.0|1.63|4.7||Criteria to assess superiority was a two-sided P value of <0.05. The study was terminated early because the pre-specified stopping boundary of P <0.0025 was crossed at the first interim analysis (N=182)|Cochran-Mantel-Haenszel||||
1608972|NCT02586025|2955296|Other||Mean Difference (Final Values)|-0.48|||||2-Sided|95.0|-1.69|0.73|||||Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm||
1608973|NCT02586025|2955305|Superiority||Difference in response rates|10.4||||0.0125|2-Sided|95.0|1.12|19.69||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm||
1608974|NCT02586025|2955307|Superiority||Difference in response rates|18.83||||0.0006|2-Sided|95.0|8.14|29.51||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.||
1608975|NCT02586025|2955308|Superiority||Difference in response rates|18.37||||0.001|2-Sided|95.0|7.6|29.15||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.||
1608976|NCT02586025|2955309|Superiority||Difference in response rates|18.36||||0.0008|2-Sided|95.0|7.89|28.83||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.||
1608977|NCT02586025|2955310|Superiority||Difference in response rates|17.45||||0.0014|2-Sided|95.0|6.89|28.01||Two-sided significance level of 5%|Cochran-Mantel-Haenszel|Stratified by disease category (early-stage and locally advanced) and hormone-receptor status (positive for ER and/or PgR or negative for both)|Pertuzumab, Trastuzumab, Docetaxel arm minus Placebo, Trastuzumab, Docetaxel arm. Approximate 95% CI for difference of two rates using Hauck-Anderson method.||
1608978|NCT02585960|2955338|Superiority||Gaussian Statistic estimate|1.96||||0.0545|2-Sided|95.0|-0.038|3.958|||Chi-squared||Approximately Gaussian Statistic is obtained by taking the square root of the Chi-squared test with continuity adjustment.|The proportion of participants with an ABR of 0 during the second 6-month period on BAX 855 prophylaxis, was compared between the 2 prophylaxis arms using a chi-square test with continuity correction at a 2-sided 5% level of significance.|
1608979|NCT02585934|2955340|Superiority||least square mean difference|-0.38||||0.2472|2-Sided|95.0|-1.03|0.27||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures|||
1608980|NCT02585934|2955341|Superiority||least square mean difference|-0.14||||0.765|2-Sided|95.0|-1.09|0.8||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures|||
1608981|NCT02585934|2955342|Superiority||least square mean difference|0.12||||0.2096|2-Sided|95.0|-0.07|0.32||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures|||
1608982|NCT02585934|2955343|Superiority||least square mean difference|-0.12||||0.0234|2-Sided|95.0|-0.22|-0.02||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures|||
1608983|NCT02585934|2955344|Superiority||least square mean difference|-0.09||||0.826|2-Sided|95.0|-0.9|0.72||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures|||
1608984|NCT02585934|2955345|Superiority||least square mean difference|-0.36||||0.2249|2-Sided|95.0|-0.95|0.22||the threshold for statistical significance was p=0.05|Mixed Models Analysis|Statistical Method: Mixed model for repeated measures|||
1608985|NCT02585895|2955346|Superiority or Other||Treatment Difference|-35.8|Standard Error of the Mean|3.74|<|0.0001|2-Sided|95.0|-43.39|-28.21|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.|||
1608986|NCT02585895|2955347|Superiority or Other||Treatment Difference|-46.37|Standard Error of the Mean|4.67|<|0.0001|2-Sided|95.0|-55.85|-36.9|||Repeated measures linear effects model|Model included treatment group, screening LDL-C level, scheduled visit, and the interaction of treatment group with scheduled visit as covariates.|Treatment difference used apheresis as the reference.||
1608988|NCT02585895|2955349|Superiority or Other||Treatment Difference|74.2|||<|0.0001|2-Sided|95.0|44.6|86.8|||Cochran-Mantel-Haenszel|Based on Cochran-Mantel-Haenszel (CMH) test stratified by screening LDL-C level|Treatment difference used apheresis as the reference.||
1608989|NCT02585778|2955369|Superiority||Adjusted Mean Difference|-5.7||||0.0902|2-Sided|95.0|-12.3|0.9||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1608990|NCT02585778|2955370|Superiority||LS Mean Difference|4.4||||0.01|2-Sided|95.0|1.1|7.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1608991|NCT02585778|2955370|Superiority||LS Mean Difference|3.9||||0.3434|2-Sided|95.0|-4.2|12.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1608992|NCT02585778|2955371|Superiority||Adjusted Mean Difference|-18.4|||<|0.0001|2-Sided|95.0|-23.7|-13.2||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1608993|NCT02585778|2955371|Superiority||Adjusted Mean Difference|-18.7|||<|0.0039|2-Sided|95.0|-31.4|-6.0||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1608994|NCT02585778|2955372|Superiority||Odds Ratio (OR)|103.3|||<|0.0001|2-Sided|95.0|24.6|433.1||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1608995|NCT02585778|2955372|Superiority||Odds Ratio (OR)|55.5|||<|0.0002|2-Sided|95.0|6.5|473.7||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1608996|NCT02585778|2955373|Superiority||Odds Ratio (OR)|27.1|||<|0.0001|2-Sided|95.0|14.2|51.5||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1608997|NCT02585778|2955373|Superiority||Odds Ratio (OR)|33.2|||<|0.0001|2-Sided|95.0|8.0|137.4||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1608998|NCT02585778|2955374|Superiority||Odds Ratio (OR)|52.9|||<|0.0001|2-Sided|95.0|16.6|168.3||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1608999|NCT02585778|2955375|Superiority||Odds Ratio (OR)|84.6|||<|0.0001|2-Sided|95.0|36.5|196.1||Threshold for significance at 0.05 level|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609000|NCT02585778|2955375|Superiority||Odds Ratio (OR)|117.0|||<|0.0001|2-Sided|95.0|13.1|1041.8||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609001|NCT02585778|2955376|Superiority||LS Mean Difference|-27.6|||<|0.0001|2-Sided|95.0|-31.2|-24.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609002|NCT02585778|2955376|Superiority||LS Mean Difference|-29.2|||<|0.0001|2-Sided|95.0|-37.8|-20.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609003|NCT02585778|2955377|Superiority||LS Mean Difference|-36.7|||<|0.0001|2-Sided|95.0|-40.9|-32.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609004|NCT02585778|2955377|Superiority||LS Mean Difference|-39.0|||<|0.0001|2-Sided|95.0|-49.4|-28.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609005|NCT02585778|2955378|Superiority||LS Mean Difference|-38.7|||<|0.0001|2-Sided|95.0|-43.4|-33.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609006|NCT02585778|2955378|Superiority||LS Mean Difference|-42.7|||<|0.0001|2-Sided|95.0|-54.2|-31.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1610245|NCT02554786|2957883|Superiority||Hazard Ratio (HR)|1.62||||0.599|2-Sided|95.0|0.27|9.7|||Regression, Cox||||
1609007|NCT02585778|2955379|Superiority||LS Mean Difference|-44.1|||<|0.0001|2-Sided|95.0|-49.0|-39.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609008|NCT02585778|2955379|Superiority||LS Mean Difference|-42.7|||<|0.0001|2-Sided|95.0|-54.9|-30.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609009|NCT02585778|2955380|Superiority||LS Mean Difference|-50.2|||<|0.0001|2-Sided|95.0|-55.2|-45.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609010|NCT02585778|2955380|Superiority||LS Mean Difference|-44.8|||<|0.0001|2-Sided|95.0|-56.9|-32.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609011|NCT02585778|2955381|Superiority||LS Mean Difference|-45.7|||<|0.0001|2-Sided|95.0|-50.9|-40.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609012|NCT02585778|2955381|Superiority||LS Mean Difference|-48.4|||<|0.0001|2-Sided|95.0|-61.2|-35.5||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609013|NCT02585778|2955382|Superiority||LS Mean Difference|-51.6|||<|0.0001|2-Sided|95.0|-56.9|-46.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant in relevant diabetes stratum).|
1609014|NCT02585778|2955382|Superiority||LS Mean Difference|-50.6|||<|0.0001|2-Sided|95.0|-63.4|-37.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level. Hierarchical testing procedure was followed for T1DM and T2DM participants separately.|
1609015|NCT02585778|2955384|Superiority||LS Mean Difference|-49.0|||<|0.0001|2-Sided|95.0|-54.4|-43.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.|
1609016|NCT02585778|2955384|Superiority||LS Mean Difference|-47.8|||<|0.0001|2-Sided|95.0|-60.7|-35.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.|
1609017|NCT02585713|2955385|Superiority|||||||0.1316|||||||Log Rank||||
1609018|NCT02584998|2955400|Other||||||<|0.001|||||||Chi-squared|||In our power and sample size analysis, we assumed 15% screening rate in usual care, 25% with invitation, and 40% with mailed-FIT. A sample size of 500 (250/arm) will give 80% power for UC vs. screening invitation-reminder, and 152/arm will give a power of 80% for the screening invitation-reminder vs. mailed-FIT. Accounting for the possibility that up to 20% of participants could be ineligible post-randomization, we concluded that we should enroll 783 patients, 261 per arm, for this trial.|
1609019|NCT02584959|2955406|Other||Difference in LS means|-31.735||||0.0001|2-Sided|95.0|-42.696|-20.773|||Mixed Models Analysis|||The Least Square means, 95% confidence intervals and p-values are based on mixed effect linear model with period, sequence, use of prophylactic therapy with C1 INH at randomization and treatment as fixed effects and subject nested within sequence as a random effect.|
1609020|NCT02584959|2955421|Other||Difference in LS means|-2.175|||<|0.0001|2-Sided|95.0|-2.75|-1.599|||Mixed Models Analysis||||
1609021|NCT02584959|2955422|Other||Difference in LS means|5.435|||<|0.0001|2-Sided|95.0|3.981|6.889|||Mixed Models Analysis||||
1609022|NCT02584959|2955423|Other||Difference in LS means|-4.881|||<|0.0001|2-Sided|95.0|-6.113|-3.649|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.|
1609023|NCT02584959|2955426|Other||Difference in LS means|-2.323|||<|0.0001|2-Sided|95.0|-2.969|-1.677|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.|
1609024|NCT02584959|2955428|Other||Difference in LS means|-2.32|||<|0.0001|2-Sided|95.0|-2.895|-1.744|||Mixed Models Analysis|||The LS means, 95% CIs, and p-values were based on a mixed effect linear model with period, sequence ,use of prophylactic therapy with C1 INH at randomization, and treatment as fixed effects and subject nested within sequence as a random effect.|
1609025|NCT02584855|2955433|Superiority||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.|
1609026|NCT02584855|2955434|Superiority||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.|
1609027|NCT02584855|2955435|Superiority||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.|
1609028|NCT02584855|2955436|Superiority||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.|
1609029|NCT02584855|2955437|Superiority||||||<|0.001|||||||Log Rank|||Log Rank Test adjusting for geographic region and cDMARD use at the time of double blind randomization.|
1609030|NCT02584855|2955440|Superiority||Odds Ratio (OR)|-45.6|||||2-Sided|95.0|-58.8|-32.3||||||Logistic regression adjusting for treatment, geographic region, and cDMARD use at the time of double-blind randomization .|
1609331|NCT02572817|2956456|Superiority||Hodges-Lehman estimate of location shift|0.0||||0.68|2-Sided|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)||||
1609033|NCT02584686|2955445|Superiority or Other|||||||1|||||||Fisher Exact|||"Fisher Exact Test was used to compare the change in patients who answered Yes in Secondary Outcome 10 (SEP-Q3 Question Before Treatment) to patients who answered Yes in Secondary Outcome 11 (SEP-Q3 Question after Treatment)."|
1609034|NCT02584686|2955447|Superiority or Other|||||||0.109091|||||||Fisher Exact|||"Fisher Exact Test was used to compare the change in the number of in patients who answered Yes in Secondary Outcome 8 (SEP-Q2 Question Before Treatment) to patients who answered Yes in Secondary Outcome 9 (SEP-Q2 Question after Treatment), for both (BTXA) and Saline groups."|
1609035|NCT02584686|2955449|Superiority or Other|||||||0.027191||||||"Due to the small sample size Fisher exact test was chosen. 7 out of 12 in the treatment group answered yes, while 1 out of 12 in the control group answered yes."|Fisher Exact||||
1609036|NCT02584686|2955450|Superiority or Other|||||||0.6618176|||||||Wilcoxon (Mann-Whitney)|||SHIM Score in the control group before & after treatment.|
1609037|NCT02584686|2955450|Superiority or Other|||||||0.00751288|||||||Wilcoxon (Mann-Whitney)|||SHIM Score in the study group before & after treatment.|
1609038|NCT02584686|2955452|Superiority or Other|||||||0.6618176|||||||Wilcoxon (Mann-Whitney)|||Comparing the Erection hardness score before & after treatment in the control group.|
1609039|NCT02584686|2955452|Superiority or Other|||||||0.01086956|||||||Wilcoxon (Mann-Whitney)|||Comparing the Erection hardness score before & after treatment in the study group.|
1609040|NCT02584686|2955454|Superiority or Other|||||||0.68|||||||t-test, 1 sided|||Comparing the mean PSV before & after treatment in the control group using the t-test.|
1609041|NCT02584686|2955454|Superiority or Other|||||||0.0049|||||||t-test, 1 sided|||Comparing the mean PSV before & after treatment in the study group using the t-test.|
1609042|NCT02584660|2955465|Superiority||Mean difference|-1.202|||<|0.0001|2-Sided|95.0|-1.73|-0.674|||t-test||||
1609043|NCT02584504|2955468|Superiority||Adjusted Mean Difference|-11.6||||0.0299|2-Sided|97.5|-23.5|0.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609044|NCT02584504|2955468|Superiority||Adjusted Mean Difference|5.9||||0.2645|2-Sided|97.5|-5.9|17.7||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609045|NCT02584504|2955469|Superiority||LS Mean Difference|7.8||||0.0022|2-Sided|97.5|2.1|13.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609046|NCT02584504|2955469|Superiority||LS Mean Difference|5.7||||0.0241|2-Sided|97.5|0.0|11.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609047|NCT02584504|2955470|Superiority||Adjusted Mean Difference|-50.9|||<|0.0001|2-Sided|97.5|-61.5|-40.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609048|NCT02584504|2955470|Superiority||Adjusted Mean Difference|-32.9|||<|0.0001|2-Sided|97.5|-43.4|-22.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609049|NCT02584504|2955471|Superiority||Odds Ratio (OR)|500.8|||<|0.0001|2-Sided|97.5|47.9|5230.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609050|NCT02584504|2955471|Superiority||Odds Ratio (OR)|102.8|||<|0.0001|2-Sided|97.5|19.0|556.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609051|NCT02584504|2955472|Superiority||Odds Ratio (OR)|281.4|||<|0.0001|2-Sided|97.5|33.3|2382.2||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609052|NCT02584504|2955472|Superiority||Odds Ratio (OR)|61.2|||<|0.0001|2-Sided|97.5|13.9|268.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609053|NCT02584504|2955473|Superiority||LS Mean Difference|-41.4|||<|0.0001|2-Sided|97.5|-46.4|-36.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609054|NCT02584504|2955473|Superiority||LS Mean Difference|-22.5|||<|0.0001|2-Sided|97.5|-27.4|-17.6||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1610438|NCT02553629|2957979|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1609055|NCT02584504|2955474|Superiority||LS Mean Difference|-57.6|||<|0.0001|2-Sided|97.5|-63.8|-51.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609056|NCT02584504|2955474|Superiority||LS Mean Difference|-32.4|||<|0.0001|2-Sided|97.5|-38.6|-26.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609057|NCT02584504|2955475|Superiority||LS Mean Difference|-56.2|||<|0.0001|2-Sided|97.5|-62.5|-49.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609058|NCT02584504|2955475|Superiority||LS Mean Difference|-31.3|||<|0.0001|2-Sided|97.5|-37.7|-25.0||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609059|NCT02584504|2955476|Superiority||LS Mean Difference|-53.4|||<|0.0001|2-Sided|97.5|-59.7|-47.1||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609060|NCT02584504|2955476|Superiority||LS Mean Difference|-27.2|||<|0.0001|2-Sided|97.5|-33.5|-20.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609061|NCT02584504|2955477|Superiority||LS Mean Difference|-51.9|||<|0.0001|2-Sided|97.5|-58.3|-45.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609062|NCT02584504|2955477|Superiority||LS Mean Difference|-26.2|||<|0.0001|2-Sided|97.5|-32.5|-19.9||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609063|NCT02584504|2955478|Superiority||LS Mean Difference|-67.3|||<|0.0001|2-Sided|97.5|-73.3|-61.3||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609064|NCT02584504|2955478|Superiority||LS Mean Difference|-51.4|||<|0.0001|2-Sided|97.5|-57.4|-45.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609065|NCT02584504|2955479|Superiority||LS Mean Difference|-66.2|||<|0.0001|2-Sided|97.5|-72.3|-60.1||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609066|NCT02584504|2955479|Superiority||LS Mean Difference|-50.5|||<|0.0001|2-Sided|97.5|-56.6|-44.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609067|NCT02584504|2955480|Superiority||LS Mean Difference|-67.4|||<|0.0001|2-Sided|97.5|-74.2|-60.5||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1609068|NCT02584504|2955480|Superiority||LS Mean Difference|-40.6|||<|0.0001|2-Sided|97.5|-47.4|-33.8||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q4W vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level. Hierarchical procedure for comparisons of Alirocumab 150 mg Q4W versus Placebo Q2W and Alirocumab 150 mg Q2W versus Placebo Q2W were processed separately.|
1609069|NCT02584504|2955481|Other|Statistical test was not planned because this comparison was for a descriptive purpose.|LS Mean Difference|-26.3|||||2-Sided|95.0|-32.5|-20.0|||||Alirocumab 150 mg Q4W group vs Alirocumab 150 mg Q2W|Alirocumab 150 mg Q4W group was compared to Alirocumab 150 mg Q2W group using an appropriate contrast statement.|
1609070|NCT02584504|2955481|Superiority||LS Mean Difference|-65.8|||<|0.0001|2-Sided|97.5|-72.9|-58.7||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis||Alirocumab 150 mg Q2W vs. Placebo|Alirocumab 150 mg Q2W group was compared to placebo group using an appropriate contrast statement.|
1609071|NCT02584504|2955481|Superiority||Least Square (LS) Mean Difference|-39.5|||<|0.0001|2-Sided|97.5|-46.5|-32.4||Threshold for significance at 0.025 level for Bonferroni adjustment.|Mixed Models Analysis|Threshold for significance at 0.025 level.|Alirocumab 150 mg Q4W vs. Placebo|Alirocumab 150 mg Q4W group was compared to placebo group using an appropriate contrast statement.|
1609072|NCT02583269|2955514|Other|||||||0.688|||||||ANOVA|||Baseline vs. 8 weeks p value log VEGF|
1609073|NCT02583269|2955514|Other|||||||0.851|||||||ANOVA|||Baseline v. 4 weeks p value log VEGF|
1609074|NCT02583269|2955515|Other|||||||0.414|||||||ANOVA|||Baseline v. 8 weeks log IL-8|
1609075|NCT02583269|2955515|Other|||||||0.119|||||||ANOVA|||Baseline v. 4 weeks log IL-8|
1609332|NCT02572817|2956457|Superiority|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Change in PEW from baseline to Day 7|
1609076|NCT02583256|2955547|Non-Inferiority|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|8.36|||||2-Sided|95.0|2.17|14.54||||||Comparison performed for strain B/Victoria.|
1609077|NCT02583256|2955547|Non-Inferiority|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|12.95|||||2-Sided|95.0|6.73|19.12||||||Comparison performed for strain B/Yamagata.|
1609078|NCT02583256|2955547|Non-Inferiority|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|-3.95|||||2-Sided|95.0|-10.02|2.15||||||Comparison performed for strain A/H3N2.|
1609079|NCT02583256|2955547|Non-Inferiority|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|9.67|||||2-Sided|95.0|3.11|16.17||||||Comparison performed for strain A/H1N1.|
1609080|NCT02583256|2955547|Non-Inferiority|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|2.6|||||2-Sided|95.0|-3.3|8.5||||||Comparison performed for strain B/Victoria.|
1609081|NCT02583256|2955547|Non-Inferiority|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|4.3|||||2-Sided|95.0|-1.8|10.4||||||Comparison performed for strain B/Yamagata.|
1609082|NCT02583256|2955547|Non-Inferiority|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|0.9|||||2-Sided|95.0|-5.6|7.3||||||Comparison performed for strain A/H3N2.|
1609083|NCT02583256|2955547|Non-Inferiority|The lower bound of two-sided 95% CI on the difference between SCR should not be below -10%.|SCR difference|1.8|||||2-Sided|95.0|-4.9|8.6||||||Comparison performed for strain A/H1N1.|
1609084|NCT02583256|2955548|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.32|||||2-Sided|95.0|1.2|1.5||||||Comparison performed for strain B/Victoria.|
1609085|NCT02583256|2955548|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.3|||||2-Sided|95.0|1.2|1.4||||||Comparison performed for strain B/Yamagata.|
1609086|NCT02583256|2955548|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.01|||||2-Sided|95.0|0.9|1.1||||||Comparison performed for strain A/H3N2.|
1609087|NCT02583256|2955548|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.4|||||2-Sided|95.0|1.3|1.5||||||Comparison performed for strain A/H1N1.|
1609088|NCT02583256|2955548|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.11|||||2-Sided|95.0|0.98|1.27||||||Comparison performed for strain B/Victoria.|
1609089|NCT02583256|2955548|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.12|||||2-Sided|95.0|1.01|1.25||||||Comparison performed for strain B/Yamagata.|
1609090|NCT02583256|2955548|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|0.99|||||2-Sided|95.0|0.9|1.09||||||Comparison performed for strain A/H3N2.|
1609091|NCT02583256|2955548|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||2-Sided|95.0|1.07|1.32||||||Comparison performed for strain A/H1N1.|
1609092|NCT02583256|2955549|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.36|||||2-Sided|95.0|1.22|1.51||||||Comparison performed for strain B/Victoria.|
1609093|NCT02583256|2955549|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.42|||||2-Sided|95.0|1.27|1.58||||||Comparison performed for strain B/Yamagata.|
1609094|NCT02583256|2955549|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.06|||||2-Sided|95.0|0.99|1.14||||||Comparison performed for strain A/H3N2|
1609095|NCT02583256|2955549|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of QIV-aQIV/QIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.39|||||2-Sided|95.0|1.28|1.51||||||Comparison performed for strain A/H1N1.|
1609096|NCT02583256|2955550|Superiority|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||2-Sided|95.0|1.1|1.3||||||Comparison performed for strain B/Victoria.|
1609097|NCT02583256|2955550|Superiority|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||2-Sided|95.0|1.1|1.3||||||Comparison performed for strain B/Yamagata.|
1609098|NCT02583256|2955550|Superiority|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|0.93|||||2-Sided|95.0|0.9|1.0||||||Comparison performed for strain A/H3N2.|
1609099|NCT02583256|2955550|Superiority|Superiority criterion for the GMT ratio: Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should exceed 1.|GMT ratio|1.19|||||2-Sided|95.0|1.1|1.3||||||Comparison performed for strain A/H1N1.|
1609100|NCT02583256|2955551|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.18|||||2-Sided|95.0|1.1|1.3||||||Comparison performed for strain B/Victoria.|
1609101|NCT02583256|2955551|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||2-Sided|95.0|1.1|1.3||||||Comparison performed for strain B/Yamagata.|
1609102|NCT02583256|2955551|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|0.93|||||2-Sided|95.0|0.9|1.0||||||Comparison performed for strain A/H3N2.|
1609103|NCT02583256|2955551|Non-Inferiority|Lower bound of two-sided 95% CI on the ratio of aQIV-aQIV/aQIV-QIV HI GMT should not fall below 0.667.|GMT ratio|1.19|||||2-Sided|95.0|1.1|1.3||||||Comparison performed for strain A/H1N1.|
1609104|NCT02583230|2955552|Superiority|||||||0.0008|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was used to evaluate the change in QIDS total scores over the eight-week study period.|||
1609105|NCT02583230|2955553|Superiority|||||||0.0005|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was used to evaluate the change in PHQ-9 total scores over the eight-week study period.|||
1609333|NCT02572817|2956457|Superiority|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Change in PEW from baseline to Day 3|
1609106|NCT02583048|2955566|Superiority||Mean Difference (Net)|12.1|||||2-Sided|95.1|5.7|18.6|||||Arm 3 minus Arm 2 difference in change from baseline estimated from ANOVA model. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.||
1609107|NCT02583048|2955566|Superiority||Mean Difference (Net)|8.4|||||2-Sided|95.1|2.0|14.8|||||Arm 3 minus Arm 1 difference in change from baseline estimated from ANOVA model. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.||
1609108|NCT02582684|2955634|Other|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|proportion|0.85|||||2-Sided|95.0|0.77|0.91|||||Confidence interval was calculated using the Clopper-Pearson exact method.||
1609109|NCT02582684|2955635|Other|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|Proportion|0.89|||||2-Sided|95.0|0.82|0.94|||||Confidence interval was calculated using the Clopper-Pearson exact method.||
1609110|NCT02582684|2955636|Other|Binomial Proportion of Participants with Virologic Success and 95% Confidence Interval|proportion|0.9|||||2-Sided|95.0|0.83|0.95|||||Confidence interval was calculated using the Clopper-Pearson exact method.||
1609111|NCT02582255|2955671|Other|||||||0.05|||||||Clopper-Pearson||||
1609112|NCT02582255|2955672|Other|||||||0.025|||||||Clopper-Pearson||||
1609113|NCT02582255|2955673|Other|||||||0.025|||||||Clopper-Pearson||||
1609114|NCT02582255|2955674|Other|||||||0.05|||||||Clopper-Pearson||||
1609115|NCT02582242|2955692|Other||Treatment difference at week 24|-0.09||||0.2601|2-Sided|95.0|-0.23|0.06|||Mixed model for repeated measurements||Treatment difference at week 24: BIAsp 30 (TID) - BIAsp 30 (BID). Number of subjects contributed to the statistical analysis: N=217 for BIAsp 30 (TID) and N=213 for BIAsp 30 (BID).|The analysis was based on a mixed-effect model for repeated measures including changes from baseline in HbA1c at visit 6, 10, 14, 18, 22 and 26 (in week 4, 8, 12, 16, 20 and 24, respectively). The model included treatment, strata and region as fixed factors, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.|
1609116|NCT02581930|2955715|Other|Exact binomial test|Probability of response|0.0||||1|1-Sided|||||Significant if p-value is less than 0.1|Exact binomial test, 1-sided||Estimated as proportion of subjects with response|The primary comparison was between the response rate of an ineffective drug, such as investigators’ choice chemotherapy (5%), and the response rate of ibrutinib.|
1609117|NCT02581891|2955724|Non-Inferiority|The non-inferiority margin is set to 5 letters.|LS mean difference|-2.0199|Standard Error of the Mean|1.3833||0.0162|2-Sided|95.0|-4.747|0.7073|||ANCOVA||||
1609118|NCT02581865|2955725|Superiority||Mean Difference (Net)|-0.5|Standard Error of the Mean|1.1||0.6289|2-Sided|95.0|-2.8|1.7|||Mixed Models Analysis||||
1609119|NCT02581865|2955725|Superiority||Mean Difference (Net)|-0.8|Standard Error of the Mean|1.1||0.4515|2-Sided|95.0|-3.0|1.3|||Mixed Models Analysis||||
1609120|NCT02581865|2955726|Superiority||Mean Difference (Net)|-4.8|Standard Error of the Mean|4.0||0.232|2-Sided|95.0|-12.8|3.1|||Mixed Models Analysis||||
1609121|NCT02581865|2955726|Superiority||Mean Difference (Net)|-2.2|Standard Error of the Mean|3.8||0.5689|2-Sided|95.0|-9.8|5.4|||Mixed Models Analysis||||
1609122|NCT02581865|2955727|Superiority||Mean Difference (Net)|-1.6|Standard Error of the Mean|0.9||0.0566|2-Sided|95.0|-3.3|0.0|||ANCOVA||||
1609123|NCT02581865|2955727|Superiority||Mean Difference (Net)|-1.0|Standard Error of the Mean|0.8||0.2215|2-Sided|95.0|-2.7|0.6|||ANCOVA||||
1609124|NCT02581865|2955728|Superiority||Mean Difference (Net)|-0.3|Standard Error of the Mean|0.2||0.2052|2-Sided|95.0|-0.7|0.2|||Mixed Models Analysis||||
1609125|NCT02581865|2955728|Superiority||Mean Difference (Net)|-0.2|Standard Error of the Mean|0.2||0.3065|2-Sided|95.0|-0.6|0.2|||Mixed Models Analysis||||
1609126|NCT02581865|2955729|Superiority||Mean Difference (Net)|-0.7|Standard Error of the Mean|0.3||0.0146|2-Sided|95.0|-1.2|-0.1|||ANOVA||||
1609127|NCT02581865|2955729|Superiority||Mean Difference (Net)|-0.2|Standard Error of the Mean|0.2||0.3812|2-Sided|95.0|-0.7|0.3|||ANOVA||||
1609128|NCT02581865|2955730|Superiority||Mean Difference (Net)|-2.5|Standard Error of the Mean|1.9||0.1835|2-Sided|95.0|-6.2|1.2|||Mixed Models Analysis||||
1609129|NCT02581865|2955730|Superiority||Mean Difference (Net)|-1.4|Standard Error of the Mean|1.8||0.4326|2-Sided|95.0|-4.9|2.1|||Mixed Models Analysis||||
1609130|NCT02581410|2955758|Non-Inferiority|Non-inferiority will be demonstrated if the upper limit of the two-sided 95% confidence interval of the adjusted geometric mean concentration (GMC) ratio (No prev- Zvax over Prev-Zvax) 1 month post-dose 2 is below 1.5 in terms of anti-gE antibodies.|Adjusted GMC ratio|1.04|||||2-Sided|95.0|0.92|1.17||||||To compare humoral immune responses at 1 month after dose 2 of GSK1437173A (Month 3) in subjects ≥ 65 years of age who received Zostavax ≥ 5 years earlier (Prev-Zvax) as compared to subjects who have never received Zostavax (No prev-Zvax).|
1609131|NCT02581345|2955789|Other|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are:[-0.15;+0.15] for 95% confidence interval.|Difference in proportion (M923 - EU RPP)|0.08|||||2-Sided|95.0|-0.004|0.162|||||||
1609132|NCT02581345|2955789|Other|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: [-0.18;+0.18] for 90% confidence interval.|Difference in proportion (M923 - EU RPP)|0.08|||||2-Sided|90.0|0.01|0.149|||||||
1609133|NCT02581345|2955792|Other|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: [-0.15;+0.15] for 95% confidence interval.|Difference in proportion (M923 - EU RPP)|-0.022|||||2-Sided|95.0|-0.069|0.024|||||||
1609250|NCT02576587|2956196|Other||median of change|-0.7||||0.59|2-Sided||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-6.2, 10.7).||
1609134|NCT02581345|2955792|Other|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale calculated using stratified Newcombe method. Protocol defined margins are: [-0.18;+0.18] for 90% confidence interval.|Difference in proportion (M923 - EU RPP)|-0.022|||||2-Sided|90.0|-0.061|0.016|||||||
1609135|NCT02581345|2955793|Other|No formal hypothesis testing of equivalence was performed for the comparison between M923 and EU RPP using the secondary efficacy outcome measures. Confidence Interval for difference in proportion in original scale was calculated using stratified Newcombe method.|Difference in proportion (M923 - EU RPP)|0.031|||||2-Sided|95.0|-0.048|0.11|||||||
1609136|NCT02581345|2955794|Equivalence|Per European Medicines Agency (EMA), the equivalence testing was made using 95% confidence interval and an equivalence margin of 15%|Difference in proportion (M923 - EU RPP)|0.014|||||2-Sided|95.0|-0.054|0.082|||||||
1609137|NCT02581345|2955794|Equivalence|Per Food and Drug Administration (FDA), the equivalence testing was made using 90% confidence interval and an equivalence margin of 18%|Difference in proportion (M923 - EU RPP)|0.014|||||2-Sided|90.0|-0.043|0.072|||||||
1609138|NCT02580799|2955860|Superiority or Other||||||=|0|||||||Chi-squared|||Abroad: Site E variability assessment|
1609139|NCT02580799|2955860|Superiority or Other||||||=|0|||||||Chi-squared|||Abroad: Site D variability assessment|
1609140|NCT02580799|2955860|Superiority or Other||||||=|0|||||||Chi-squared|||Abroad: Site C variability assessment|
1609141|NCT02580799|2955860|Superiority or Other||||||=|0|||||||Chi-squared|||Abroad: Site B variability assessment|
1609142|NCT02580799|2955860|Superiority or Other||||||=|0|||||||Chi-squared|||Abroad: Site A variability assessment|
1609143|NCT02580799|2955862|Superiority or Other||||||=|0|||||||Chi-squared|||Site D: Site E variability assessment|
1609144|NCT02580799|2955862|Superiority or Other||||||=|0|||||||Chi-squared|||Site C: Site E variability assessment|
1609145|NCT02580799|2955862|Superiority or Other||||||=|0|||||||Chi-squared|||Site C: Site D variability assessment|
1609146|NCT02580799|2955875|Superiority or Other||||||=|0|||||||Chi-squared|||Site B: Site E variability assessment|
1609147|NCT02580799|2955875|Superiority or Other||||||=|0|||||||Chi-squared|||Site B: Site D variability assessment|
1609148|NCT02580799|2955875|Superiority or Other||||||=|0|||||||Chi-squared|||Site B: Site C variability assessment|
1609149|NCT02580799|2955877|Superiority or Other||||||=|0|||||||Chi-squared|||Site A: Site E variability assessment|
1609150|NCT02580799|2955877|Superiority or Other||||||=|0|||||||Chi-squared|||Site A: Site D variability assessment|
1609151|NCT02580799|2955877|Superiority or Other||||||=|0|||||||Chi-squared|||Site A: Site C variability assessment|
1609152|NCT02580799|2955877|Superiority or Other||||||=|0|||||||Chi-squared|||Site A: Site B variability assessment|
1609153|NCT02580591|2955879|Superiority||Mean Difference (Final Values)|-1.4||||0.0202|2-Sided|99.75|-3.3|0.4|||Mixed effect Model Repeat Measurement|||For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, ß, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609154|NCT02580591|2955879|Superiority||Mean Difference (Final Values)|-1.7||||0.0047|2-Sided|99.75|-3.6|0.1|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, ß, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609155|NCT02580591|2955879|Superiority||Mean Difference (Final Values)|-0.3|||||2-Sided|95.0|-1.5|0.9|||||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model includes baseline DBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609156|NCT02580591|2955879|Superiority||Mean Difference (Final Values)|-3.7|||<|0.0001|2-Sided|99.75|-6.6|-0.9|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609157|NCT02580591|2955879|Superiority||Mean Difference (Final Values)|-3.9|||<|0.0001|2-Sided|99.75|-6.8|-1.1|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, , treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609158|NCT02580591|2955879|Superiority||Median Difference (Final Values)|-2.1|||<||2-Sided|95.0|-3.9|-0.2|||||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609223|NCT02578680|2956038|Superiority||Hazard Ratio (HR)|0.49|||<|1e-05|2-Sided|95.0|0.38|0.64|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. <1%), platinum chemotherapy (cisplatin vs. carboplatin) & smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.||
1610439|NCT02553629|2957980|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1609159|NCT02580591|2955880|Superiority||Mean Difference (Final Values)|-0.091|Standard Error of the Mean|0.01|<|0.0001|2-Sided|99.75|-0.122|-0.06|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609160|NCT02580591|2955880|Superiority||Mean Difference (Final Values)|-0.07|||<|0.0001|2-Sided|99.75|-0.101|-0.039|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609161|NCT02580591|2955880|Superiority||Mean Difference (Final Values)|-0.049|||<||2-Sided|95.0|-0.069|-0.03|||||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline total daily insulin dose, baseline estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609162|NCT02580591|2955881|Superiority||Mean Difference (Final Values)|-3.43|||<|0.0001|2-Sided|99.75|-4.3|-2.57|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609163|NCT02580591|2955881|Superiority||Mean Difference (Final Values)|-3.04|||<|0.0001|2-Sided|99.75|-3.91|-2.18|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609164|NCT02580591|2955881|Superiority||Mean Difference (Final Values)|-1.76|||<||2-Sided|95.0|-2.32|-1.2|||||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline weight, baseline Estimated glomerular filtration rate (eGFR), baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609165|NCT02580591|2955882|Superiority||Adjusted Rate Ratio (%)|1.051||||0.7543|2-Sided|95.0|0.771|1.433||This is a nominal p-value.|Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk [days]) was used as offset.|
1609166|NCT02580591|2955882|Superiority||Adjusted Rate Ratio (%)|1.258||||0.1438|2-Sided|95.0|0.925|1.713||This is a nominal p-value.|Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk [days]) was used as offset.|
1609167|NCT02580591|2955882|Superiority||Adjusted Rate Ratio (%)|0.932|||||2-Sided|95.0|0.682|1.274||||||For Week 1 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk [days]) was used as offset.|
1609168|NCT02580591|2955882|Superiority||Adjusted Rate Ratio (%)|1.02||||0.9077|2-Sided|97.75|0.693|1.501|||Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk [days]) was used as offset.|
1609169|NCT02580591|2955882|Superiority||Adjusted Rate Ratio (%)|1.202||||0.2752|2-Sided|97.75|0.818|1.766|||Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk [days]) was used as offset.|
1609170|NCT02580591|2955882|Superiority||Adjusted Rate Ratio (%)|0.94|||||2-Sided|95.0|0.673|1.314|||||Empagliflozin 2.5 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For Week 5 to 26, negative binomial model includes baseline rate of hypoglycemia, baseline HbA1c, and baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk [days]) was used as offset.|
1609171|NCT02580591|2955883|Superiority||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.07|<|0.0001|2-Sided|97.5|-0.66|-0.35|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609247|NCT02576938|2956164|Superiority||||||=|0|||||||Chi-squared||||
1609172|NCT02580591|2955883|Superiority||Median Difference (Final Values)|-0.44|Standard Error of the Mean|0.07|<|0.0001|2-Sided|97.5|-0.59|-0.28|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609173|NCT02580591|2955883|Superiority||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.07|<||2-Sided|95.0|-0.4|-0.14|||||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609174|NCT02580591|2955884|Superiority||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.07|<|0.0001|2-Sided|97.5|-0.68|-0.37|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609175|NCT02580591|2955884|Superiority||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.07|<|0.0001|2-Sided|97.5|-0.6|-0.3|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609176|NCT02580591|2955884|Superiority||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.07|<|0.0001|2-Sided|99.0|-0.46|-0.11|||Mixed effect Model Repeat Measurement||Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model includes baseline HbA1c, baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.|
1609177|NCT02580318|2955888|Other||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after drinking water)|t-test, 2 sided|||p value calculated for drinking water (5 minutes)|
1609178|NCT02580318|2955888|Other||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (immediately after drinking water)|t-test, 2 sided|||p value calculated for drinking water (immediate)|
1609179|NCT02580318|2955888|Other||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (10 minutes after hyperventilation)|t-test, 2 sided|||p value calculated for hyperventilation (after 10 minutes)|
1609180|NCT02580318|2955888|Other||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (5 minutes after hyperventilation)|t-test, 2 sided|||p value calculated for hyperventilation (after 5 minutes)|
1609181|NCT02580318|2955888|Other||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (hyperventilation - immediate)|t-test, 2 sided|||p value calculated for hyperventilation (immediate)|
1609182|NCT02580318|2955888|Other||||||<|0.0001||||||the separate paired sample t-tests were conducted to compare the baseline BrAC to the BrAC after the manipulation (poor effort)|t-test, 2 sided|||this p value is calculated for poor effort|
1609183|NCT02580058|2955912|Superiority||Hazard Ratio (HR)|0.78||||0.0301|2-Sided|95.0|0.607|1.011|||Log Rank|1-sided|||
1609184|NCT02580058|2955912|Superiority||Hazard Ratio (HR)|1.68|||>|0.9999|2-Sided|95.0|1.31|2.16|||Log Rank|1-sided|||
1609185|NCT02580058|2955913|Superiority||Hazard Ratio (HR)|0.89||||0.2082|2-Sided|95.0|0.672|1.179|||Log Rank|1-sided|||
1609186|NCT02580058|2955913|Superiority||Hazard Ratio (HR)|1.14||||0.8253|2-Sided|95.0|0.867|1.497|||Log Rank|1-sided|||
1609187|NCT02579863|2955933|Superiority||Hazard Ratio (HR)|0.92||||0.36091|2-Sided|95.0|0.57|1.47|||Log Rank|One-sided p-value based on Stratified log-rank test.|Based on Cox regression model with treatment as a covariate stratified by Age (<75 years vs >= 75 years) and ISS stage (I or II vs. III).||
1609188|NCT02579759|2955941|Superiority||Odds Ratio (OR)|1.26||||0.569|2-Sided|97.5|0.5|3.16|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.|
1609189|NCT02579759|2955941|Superiority||Odds Ratio (OR)|3.39||||0.026|2-Sided|97.5|0.99|11.62|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.|
1609190|NCT02579759|2955942|Superiority||Odds Ratio (OR)|1.07||||0.865|2-Sided|97.5|0.42|2.7|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.|
1609191|NCT02579759|2955942|Superiority||Odds Ratio (OR)|2.09||||0.097|2-Sided|97.5|0.77|5.68|||General Linear Mixed Model|||The proportion of responders (on Completers selection only) at the end of treatment was assessed through a Generalized Linear Mixed Model (GLMM) featuring logistic regression including treatment as a fixed effect, adjusting for the baseline value and center as a random effect.|
1609329|NCT02572817|2956454|Superiority||Hodges-Lehman estimate of location shift|-1.5||||0.37|2-Sided|95.0|-6.0|2.0|||Wilcoxon (Mann-Whitney)||||
1609192|NCT02579759|2955946|Superiority||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.11||0.162|2-Sided|97.5|-0.4|0.09|||ANCOVA|||"The main analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609193|NCT02579759|2955946|Superiority||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.13||0.023|2-Sided|97.5|-0.58|0.0|||ANCOVA|||"The main analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609194|NCT02579759|2955950|Superiority||Slope|-0.19|Standard Error of the Mean|0.22||0.373|2-Sided|95.0|-0.62|0.23|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609195|NCT02579759|2955950|Superiority||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|0.38||0.334|2-Sided|97.5|-1.21|0.48|||ANCOVA|||"The main analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609196|NCT02579759|2955950|Superiority||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.46||0.377|2-Sided|97.5|-1.43|0.62|||ANCOVA|||"The main analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609197|NCT02579759|2955951|Superiority||Slope|-0.18|Standard Error of the Mean|0.18||0.322|2-Sided|95.0|-0.53|0.17|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609198|NCT02579759|2955951|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.31||0.868|2-Sided|97.5|-0.74|0.64|||ANCOVA|||"The main analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609199|NCT02579759|2955951|Superiority||Mean Difference (Final Values)|-0.43|Standard Error of the Mean|0.36||0.232|2-Sided|97.5|-1.25|0.38|||ANCOVA|||"The main analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609200|NCT02579759|2955952|Superiority||Slope|-0.17|Standard Error of the Mean|0.13||0.204|2-Sided|95.0|-0.43|0.09|||Regression, Linear|||"Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609201|NCT02579759|2955952|Superiority||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.23||0.556|2-Sided|97.5|-0.66|0.39|||ANCOVA|||"The main analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609202|NCT02579759|2955952|Superiority||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.28||0.162|2-Sided|97.5|-1.01|0.23|||ANCOVA|||"The main analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609203|NCT02579759|2955953|Superiority||Slope|-0.22|Standard Error of the Mean|0.09||0.015|2-Sided|95.0|-0.41|-0.04|||Regression, Linear|||"Dose effect:~Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609204|NCT02579759|2955953|Superiority||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.16||0.084|2-Sided|97.5|-0.65|0.08|||ANCOVA|||"The main analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609248|NCT02576587|2956194|Other||mean of change|-1.7|Standard Deviation|12.2||0.65|2-Sided||||||t-test, 2 sided|Paired t test was used to compare pre- and post- treatment outcomes.|||
1609205|NCT02579759|2955953|Superiority||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.19||0.016|2-Sided|97.5|-0.91|-0.03|||ANCOVA|||"The main analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609206|NCT02579759|2955954|Superiority||Slope|-0.17|Standard Error of the Mean|0.07||0.013|2-Sided|95.0|-0.31|-0.04|||Regression, Linear|||"Dose effect:~Dose is defined as a numerical variable proportional to quantity of PXT3003 administered (0 for Placebo, 1 for Dose 1, 2 for Dose 2).~The analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA assessing the dose-effect at the mean of 12 and 15 months, adjusting for baseline value and assuming centre as random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609207|NCT02579759|2955954|Superiority||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.1||0.05|2-Sided|97.5|-0.42|0.03|||Longitudinal mixed model|||"This analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: Longitudinal model where the effect of each treatment over time (baseline, 6, 12 and 15 months) was estimated through a mixed model with repeated measures (MMRM) assuming time from baseline (Time) and Time-by-Treatment full interaction as fixed effects and patient as random effect and considering Time as continuous linear effect~Missing value imputation: No imputation"|
1609208|NCT02579759|2955954|Superiority||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.13||0.013|2-Sided|97.5|-0.59|-0.03|||Longitudinal mixed model|||"This analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: Longitudinal model where the effect of each treatment over time (baseline, 6, 12 and 15 months) was estimated through a mixed model with repeated measures (MMRM) assuming time from baseline (Time) and Time-by-Treatment full interaction as fixed effects and patient as random effect and considering Time as continuous linear effect~Missing value imputation: No imputation"|
1609209|NCT02579759|2955954|Superiority||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.12||0.287|2-Sided|97.5|-0.39|0.14|||ANCOVA|||"The main analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609210|NCT02579759|2955954|Superiority||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.14||0.008|2-Sided|97.5|-0.68|-0.06|||ANCOVA|||"The main analysis was performed as follows:~Analysis population: modified Full Analysis Set (mFAS)~Statistical model: ANCOVA where the mean at 12 and 15 months of each treatment group was compared against the placebo group, adjusting for the baseline value and assuming centre as a random effect~Missing value imputation: multiple imputation taking into account the reason of missingness"|
1609211|NCT02579382|2955981|Superiority||Least Squares Mean Difference|0.127||||0.151|2-Sided|95.0|-0.047|0.301||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM||||
1609212|NCT02579382|2955981|Superiority||Least Squares Mean Difference|0.018||||0.84|2-Sided|95.0|-0.156|0.191||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM||||
1609213|NCT02579382|2955981|Superiority||Least Squares Mean Difference|0.107||||0.227|2-Sided|95.0|-0.067|0.282||MMRM model included treatment, baseline ALT level, HBeAg baseline status, baseline HBsAg, visit and treatment-by-visit interaction as fixed effect and visit as repeated measurement.|MMRM||||
1609214|NCT02579135|2955982|Superiority|Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).|beta|8.31|Standard Error of the Mean|2.71|<|0.001|2-Sided||||||Regression, Linear|||We used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.|
1609215|NCT02579135|2955983|Superiority|Before the onset of the study, we conducted a power calculation to determine the appropriate sample size. We designed the study to have 80% power at a .05 significance level to detect differences in primary outcomes, assuming an effect size of 0.5 and a correlation of 0.4 between assessments. Final enrollment (n= 222) exceeded our target sample size (n= 150).|beta|0.05|Standard Error of the Mean|0.05||0.32|2-Sided||||||Regression, Linear|||Third, to assess the effectiveness of the HEART intervention from pretest to immediate posttest, we used linear regression analyses to compute adjusted means and mean differences between intervention and control groups. We included an indicator for school to adjust for clustering by school. For each outcome, the corresponding pretest measure was included as a covariate.|
1609216|NCT02578745|2956003|Superiority|||||||0.5|||||||Chi-squared||||
1609217|NCT02578745|2956004|Superiority||||||>|0.99|||||||Chi-squared||||
1609218|NCT02578745|2956005|Superiority||||||>|0.99|||||||Chi-squared||||
1609219|NCT02578745|2956006|Superiority|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1609220|NCT02578745|2956007|Superiority||Risk Ratio (RR)|1.67||||0.72|2-Sided|95.0|0.42|6.67|||Chi-squared||||
1609221|NCT02578745|2956008|Superiority||Risk Ratio (RR)|1.67||||0.72|2-Sided|95.0|0.42|6.67|||Chi-squared||||
1609222|NCT02578680|2956037|Superiority||Difference in Percentage vs. Control|28.5|||<|0.0001|2-Sided|95.0|21.1|35.4||H0:Difference in percentages=0 vs H1:Difference in percentages>0|Stratified Miettinen and Nurminen||Miettinen and Nurminen method with treatment as a covariate stratified by PD-L1 status (≥1% vs. <1%), platinum chemotherapy (cisplatin vs. carboplatin) & smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.||
1609249|NCT02576587|2956195|Other||mean of change|0.62|Standard Deviation|4.2||0.65|2-Sided||||||t-test, 2 sided|Paired t test was used to compare pre- and post- treatment outcomes.|||
1610440|NCT02553629|2957981|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1609224|NCT02578680|2956039|Superiority||Hazard Ratio (HR)|0.52|||<|1e-05|2-Sided|95.0|0.43|0.64|||Log Rank||Based on Cox regression model with treatment as a covariate stratified by PD-L1 status (≥1% vs. <1%), platinum chemotherapy (cisplatin vs. carboplatin) & smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.||
1609225|NCT02578186|2956057|Superiority or Other|||||||0.0312|||||||ANCOVA||||
1609226|NCT02577510|2956097|Other|||||||0.05|||||||t-test, 1 sided|||Statistical analysis was performed using SPSS Version 21 statistical software (IBM, Armonk, New York). For continuous data, normality was fi rst assessed with the Lilliefors test and then analyzed using a paired t test. Data that did not have a normal distribution, as well as ordinal data, was analyzed using Wilcoxon’s signed ranks or McNemar’s test. All P values presented were 2-sided and values inferior to 0.05 were considered signifi cant|
1609227|NCT02577315|2956104|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|93.55|||||2-Sided|90.0|82.86|105.61|||||Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination|
1609228|NCT02577315|2956105|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|100.3|||||2-Sided|90.0|97.532|103.149|||||Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination|
1609229|NCT02577315|2956106|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|101.07|||||2-Sided|90.0|95.565|106.902|||||Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination|
1609230|NCT02577315|2956107|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|102.71|||||2-Sided|90.0|97.309|108.413|||||Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination|
1609231|NCT02577315|2956108|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|95.51|||||2-Sided|90.0|89.29|102.16|||||Relative bioavailability of Metformin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination|
1609232|NCT02577315|2956109|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of geometric means|100.1|||||2-Sided|90.0|97.466|102.804|||||Relative bioavailability of Empagliflozin was estimated by the ratios of the adjusted geometric means (gMean).|Empagliflozin / Metformin (FDC) vs. Empagliflozin + Metformin free combination|
1609233|NCT02577107|2956115|Superiority or Other||Mean Difference (Final Values)|20.314|Standard Error of the Mean|4.1613|||2-Sided|95.0|9.618|31.011|||||||
1609234|NCT02577016|2956128|Superiority||Difference in least squares means|-11.2|||<|0.001|2-Sided|95.0|-17.2|-5.2|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.|||
1609235|NCT02577016|2956129|Superiority||Difference in least squares means|-67.0|||<|0.001|2-Sided|95.0|-84.0|-50.0|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.|||
1609236|NCT02577016|2956130|Superiority||Difference in least squares means|-42.5|||<|0.001|2-Sided|95.0|-53.7|-31.2|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.|||
1609237|NCT02577016|2956133|Superiority||Difference in least squares means|-0.83|||<|0.001|2-Sided|95.0|-1.05|-0.62|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.|||
1609238|NCT02577003|2956134|Superiority||Difference in least squares means|-1.8|||<|0.001|2-Sided|95.0|-2.5|-1.1|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.|||
1609239|NCT02577003|2956135|Superiority||Difference in least squares means|-84.6|||<|0.001|2-Sided|95.0|-102.6|-66.6|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.|||
1609240|NCT02577003|2956136|Superiority||Difference in least squares means|-48.5|||<|0.001|2-Sided|95.0|-59.6|-37.5|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.|||
1609241|NCT02577003|2956137|Superiority||Difference in least squares means|-28.1|||<|0.001|2-Sided|95.0|-34.8|-21.5|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.|||
1609242|NCT02577003|2956140|Superiority||Difference in least squares means|-0.77|||<|0.001|2-Sided|95.0|-0.98|-0.57|||Constrained longitudinal data analysis|Based on a cLDA model with the terms listed above.|||
1609243|NCT02576977|2956145|Superiority||Difference in % vs. SOC|-5.2||||0.79921|2-Sided|95.0|-17.1|6.9|||Miettinen & Nurminen method||||Based on Miettinen & Nurminen method stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more); If there were no participants in one of the treatment groups involved in a comparison for a particular stratum, then that stratum was excluded from the treatment comparison.
1609244|NCT02576977|2956146|Superiority||Hazard Ratio (HR)|1.86||||0.99886|2-Sided|95.0|1.24|2.78|||Log Rank|One-sided p-value based on Stratified log-rank test.|||The Hazard Ratio and 95% confidence intervals were based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).
1609245|NCT02576977|2956147|Superiority||Hazard Ratio (HR)|1.5||||0.99324|2-Sided|95.0|1.08|2.08|||Log Rank|One-sided p-value based on Stratified log-rank test.|Based on Cox regression model with treatment as a covariate stratified by disease status (refractory vs. sensitive to Lenalidomide) and Lines of previous treatments (two vs. three or more).||
1609246|NCT02576938|2956164|Superiority||||||=|0|||||||Chi-squared||||
1609251|NCT02576587|2956197|Other||median of change|-3.7||||0.006|2-Sided||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-8.0, -0.57).||
1609252|NCT02576587|2956198|Other||median of change|1.8||||0.088|2-Sided||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|Inter-quartile range of the change (post minus pre) is (-2.0, 6.0).||
1609253|NCT02576587|2956199|Other||median of change|3.4||||0.16|2-Sided||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test was used to compare pre- and post- treatment outcomes.|||Inter-Quartile Range of the change (post minus pre) is (-7.0, 13.7).
1609254|NCT02576587|2956200|Other|Conditional logistic regression was used to assess the relationship of PAF and LA systolic strain apical two-chamber (A2C) on matched pairs of case and control.|Odds Ratio (OR)|0.99|Standard Error of the Mean|0.013||0.49|2-Sided|95.0|0.97|1.02|||Conditional logistic regression|N=212 (106 cases and 106 controls)|||
1609255|NCT02576587|2956200|Other|Conditional logistic regression was used to assess the relationship of PAF and LA systolic strain apical four-chamber (A4C) on matched pairs of case and control.|Odds Ratio (OR)|0.99|Standard Error of the Mean|0.013||0.39|2-Sided|95.0|0.96|1.01|||Conditional logistic regression|N=214 (107 cases and 107 controls)|||
1609256|NCT02576587|2956200|Other|Conditional logistic regression was used to assess the relationship of PAF and LA volume index on matched pairs of case and control.|Odds Ratio (OR)|1.03|Standard Error of the Mean|0.015||0.03|2-Sided|95.0|1.0|1.06|||Conditional logistic regression|N=268 (134 cases and 134 controls)|||
1609257|NCT02576587|2956200|Other|Conditional logistic regression was used to assess the relationship of PAF and LA volume on matched pairs of case and control.|Odds Ratio (OR)|1.02|Standard Error of the Mean|0.007||0.014|2-Sided|95.0|1.0|1.03|||Conditional logistic regression|N = 270 (135 cases and 135 controls)|||
1609258|NCT02576587|2956200|Other|Conditional logistic regression was used to assess the relationship of PAF and AHI on matched pairs of case and control.|Odds Ratio (OR)|0.98|Standard Error of the Mean|0.007||0.054|2-Sided|95.0|0.97|1.0|||Conditional logistic regression||||
1609259|NCT02576054|2956233|Non-Inferiority|The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|3.05|||<|0.001|2-Sided|95.0|2.33|3.99|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 18|
1609260|NCT02576054|2956233|Non-Inferiority|The statistical criterion for success requires that the lower bound of two-sided 95% CI of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|1.69|||<|0.001|2-Sided|95.0|1.35|2.11|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 16|
1609261|NCT02576054|2956233|Non-Inferiority|The statistical criterion for success requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|2.3|||<|0.001|2-Sided|95.0|1.89|2.78|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio = GMT PN200 divided by GMT PN122|Anti-HPV 11|
1609262|NCT02576054|2956233|Non-Inferiority|The statistical criterion for success requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio between boys enrolled in V501-200 and men enrolled in the Phase III study V501-122 be greater than 0.5% for each HPV type|GMT Ratio|1.25|||<|0.001|2-Sided|95.0|1.0|1.57|||ANOVA|Log-transformed data using an analysis of variance model with a term for age-group|GMT Ratio= GMT PN200 divided by GMT PN122|Anti-HPV 6|
1609263|NCT02575950|2956254|Superiority||Mean Difference (Final Values)|-9.34|||<|0.001|2-Sided|95.0|-14.71|-3.96|||ANCOVA|||Least square mean values and difference is from ANCOVA model with treatment as fixed effect and baseline total lesion count as covariate and participants as random effect. 100 simulations of monotone multiple imputation is performed. Summary statistics are found across these 100 simulations.|
1609264|NCT02575833|2956265|Superiority||Hazard Ratio (HR)|1.24||||0.39|2-Sided|90.0|0.82|1.87|||Cox Proportional Hazard|Adjusted by baseline total exercise time strata (< 7 or ≥ 7 minutes), age group (< 65, ≥ 65), and sex.|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio < 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.||
1609265|NCT02575833|2956265|Superiority||Hazard Ratio (HR)|1.08||||0.75|2-Sided|90.0|0.73|1.6|||Cox Proportional Hazard|Adjusted by continuous baseline total exercise time|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio < 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.||
1609266|NCT02575833|2956265|Superiority||Hazard Ratio (HR)|1.14||||0.59|2-Sided|90.0|0.76|1.69|||Cox Proportional Hazard|Adjusted by stratified baseline total exercise time strata (< 7 or ≥ 7 minutes)|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio < 1.0 indicates a lower average event rate and a longer exercise-induced ST-segment depression free survival for erenumab 140 mg relative to placebo.||
1609267|NCT02575833|2956265|Superiority|The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.|Normal score|2.2||||0.59|||||||Stratified Log Rank|Log rank test stratified by baseline total exercise time strata (< 7 minutes or ≥ 7 minutes).|A normal score < 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.||
1609268|NCT02575833|2956266|Superiority||Hazard Ratio (HR)|0.82||||0.47|2-Sided|90.0|0.52|1.28|||Cox Proportional Hazard|Adjusted by baseline total exercise time strata (< 7 or ≥ 7 minutes), age group (< 65, ≥ 65), and sex.|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio < 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.||
1609269|NCT02575833|2956266|Superiority||Hazard Ratio (HR)|0.81||||0.44|2-Sided|90.0|0.52|1.26|||Cox Proportional Hazard|Adjusted by continuous baseline total exercise time|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio < 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.||
1609270|NCT02575833|2956266|Superiority||Hazard Ratio (HR)|1.11||||0.69|2-Sided|90.0|0.73|1.69|||Cox Proportional Hazard|Adjusted by stratified baseline total exercise time strata (< 7 or ≥ 7 minutes)|Hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio < 1.0 indicates a lower average event rate and a longer exercise-induced angina free survival for erenumab 140 mg relative to placebo.||
1609271|NCT02575833|2956266|Superiority|The log-rank test statistic was used to compare the two treatment groups at a significance level of 0.10.|Normal score|1.55||||0.69|||||||Stratified Log Rank|Log rank test stratified by baseline total exercise time strata (< 7 minutes or ≥ 7 minutes).|A normal score < 0 indicates fewer than expected events for erenumab 140 mg relative to placebo and therefore a longer survival time.||
1609272|NCT02575833|2956267|Non-Inferiority|The non-inferiority margin was -90 seconds.|Treatment Difference|-11.0|Standard Error of the Mean|20.4|||2-Sided|90.0|-44.9|22.9||||||The primary endpoint was analyzed using an analysis of variance model with terms for treatment group and randomization strata (< 7 or ≥ 7 minutes). If the lower bound of the 90% confidence interval (CI) of the difference in change from baseline in exercise duration was above the non-inferiority margin of -90 seconds, then the hypothesis that erenumab does not decrease exercise duration would be supported.|
1609273|NCT02574845|2956302|Superiority or Other||Adjusted geometric mean ratio T5/REF (%)|118.1|||||2-Sided|90.0|106.75|130.67||||||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.|
1609274|NCT02574845|2956302|Superiority or Other||Adjusted geometric mean ratio T4/REF (%)|105.63|||||2-Sided|90.0|92.2|121.0||||||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.|
1609275|NCT02574845|2956302|Superiority or Other||Adjusted geometric mean ratio T3/REF (%)|146.45|||||2-Sided|90.0|135.21|158.62||||||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.|
1609276|NCT02574845|2956302|Superiority or Other||Adjusted geometric mean ratio T2/REF (%)|107.26|||||2-Sided|90.0|97.65|117.81||||||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.|
1609277|NCT02574845|2956302|Superiority or Other||Adjusted geometric mean ratio T1/REF (%)|101.22|||||2-Sided|90.0|89.23|114.82||||||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.|
1609278|NCT02574845|2956303|Superiority or Other||Adjusted geometric mean ratio T5/REF (%)|117.98|||||2-Sided|90.0|98.27|141.65||||||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.|
1609279|NCT02574845|2956303|Superiority or Other||Adjusted geometric mean ratio T4/REF (%)|106.81|||||2-Sided|90.0|91.78|124.3||||||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.|
1609280|NCT02574845|2956303|Superiority or Other||Adjusted geometric mean ratio T3/REF (%)|154.07|||||2-Sided|90.0|131.7|180.24||||||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.|
1609281|NCT02574845|2956303|Superiority or Other||Adjusted geometric mean ratio T2/REF (%)|106.98|||||2-Sided|90.0|92.54|123.69||||||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.|
1609282|NCT02574845|2956303|Superiority or Other||Adjusted geometric mean ratio T1/REF (%)|102.47|||||2-Sided|90.0|87.19|120.42||||||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.|
1609283|NCT02574845|2956304|Superiority or Other||Adjusted geometric mean ratio T5/REF (%)|115.92|||||2-Sided|90.0|101.93|131.82||||||This statistical analysis assess the effect of coadministration of 5 mg furosemide on the primary outcome measure of the REF treatment.|
1609284|NCT02574845|2956304|Superiority or Other||Adjusted geometric mean ratio T4/REF (%)|106.97|||||2-Sided|90.0|94.34|121.3||||||This statistical analysis assess the effect of coadministration of 1 mg furosemide on the primary outcome measure of the REF treatment.|
1609285|NCT02574845|2956304|Superiority or Other||Adjusted geometric mean ratio T3/REF (%)|152.18|||||2-Sided|90.0|135.12|171.41||||||This statistical analysis assess the effect of coadministration of 500 mg metformin hydrochloride on the primary outcome measure of the REF treatment.|
1609286|NCT02574845|2956304|Superiority or Other||Adjusted geometric mean ratio T2/REF (%)|106.09|||||2-Sided|90.0|96.12|117.11||||||This statistical analysis assess the effect of coadministration of 50 mg metformin hydrochloride on the primary outcome measure of the REF treatment.|
1609287|NCT02574845|2956304|Superiority or Other||Adjusted geometric mean ratio T1/REF (%)|101.95|||||2-Sided|90.0|89.49|116.15||||||This statistical analysis assess the effect of coadministration of 10 mg metformin hydrochloride on the primary outcome measure of the REF treatment.|
1609288|NCT02574481|2956329|Non-Inferiority|A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions..|||||<|0.0001||||||A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions. If the P-value from the one-sided Farrington-Manning test is <0.05, Eluvia is concluded to be non-inferior to Zilver PTX.|Farrington-Manning||||
1609289|NCT02574481|2956330|Non-Inferiority|A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions.|||||<|0.0001||||||A two-group Farrington-Manning test is used to test the one-sided hypothesis of non-inferiority in proportions. If the P-value from the one-sided Farrington-Manning test is <0.05, Eluvia is concluded to be non-inferior to Zilver PTX.|Farrington-Manning||||
1609290|NCT02574312|2956336|Non-Inferiority|Non-Inferiority Analysis of absolute value of mechanical axis alignment with NI margin of 1.5 degrees, using a 1-sided T-test with alpha of 0.05. Anticipated power was 95%.||||||0.028|||||||t-test, 1 sided||||
1609291|NCT02574247|2956340|Other|||||||0.04|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for row IEEE slope|
1609292|NCT02574247|2956340|Other|||||||0.03|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM slope|
1609293|NCT02574247|2956343|Other|||||||0.2|||||||Spearman partial rank correlation|Age and high-frequency average controlled for.||Statistical analysis for the row IEEE at -3 dB SNR|
1609294|NCT02574247|2956343|Other|||||||0.24|||||||Spearman partial rank correlation|Age and high-frequency average controlled for.||Statistical analysis for the row IEEE at -6 dB SNR|
1609295|NCT02574247|2956343|Other|||||||0.64|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM at -6 dB SNR|
1609296|NCT02574247|2956343|Other|||||||0.34|||||||Spearman partial rank correlation|Age and high-frequency pure-tone average controlled for.||Statistical analysis for the row CRM at -9 dB SNR|
1609297|NCT02573870|2956350|Non-Inferiority or Equivalence|p-values were not presented as non-inferiority was assessed by confidence interval (CI).|Mean Difference (Final Values)|-2.245|||||2-Sided|95.0|-6.153|1.663|||||Treatment difference is calculated as active minus placebo and the non-inferiority bound was 10 bpm for Day 42||
1609298|NCT02573233|2956388|Superiority||LS Mean Difference|-22.0||||0.0005|2-Sided|90.0|-31.3|-12.8||Threshold for significance at 0.05 level|MMRM|||Analysis was performed using a Mixed-effect model with Repeated Measures (MMRM) with treatment, treatment-by-visit interaction, region, and ICS dose level as fixed effects, and baseline biomarker-by-visit interaction as fixed covariate, and assuming an unstructured covariance structure separately by treatment group.|
1609299|NCT02573233|2956389|Superiority||LS Mean Difference|-22.4||||0.0012|2-Sided|90.0|-32.9|-11.9||Threshold for significance at 0.05 level|MMRM|||Analysis was performed using a Mixed-effect Model with Repeated Measures (MRMM) with treatment, treatment-by-visit interaction, region, and ICS dose level as fixed effects, and baseline biomarker-by-visit interaction as fixed covariate, and assuming an unstructured covariance structure separately by treatment group.|
1609300|NCT02573233|2956390|Superiority|||||||0.7588||||||Threshold for significance at 0.05 level|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.|
1609301|NCT02573233|2956391|Superiority|||||||0.6865||||||Threshold for significance at 0.05 level.|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.|
1609302|NCT02573233|2956392|Superiority||LS mean difference|-18.98||||0.4494|2-Sided|90.0|-60.92|22.97||Threshold for significance at 0.05 level.|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.|
1609303|NCT02573233|2956393|Superiority||LS mean difference|13.89||||0.4795|2-Sided|90.0|-19.0|46.78||Threshold for significance at 0.05 level.|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.|
1609304|NCT02573233|2956394|Superiority||LS Mean Difference|-235.02||||0.0336|2-Sided|90.0|-414.19|-55.84||Threshold for significance at 0.05 level|Linear fixed-effect model|||Analysis was performed using a linear fixed-effect model with treatment, region and ICS dose level as fixed effects, and the baseline value as continuous covariate.|
1609305|NCT02573233|2956395|Superiority|||||||0.84||||||Threshold for significance at 0.05 level|Rank ANCOVA|Rank ANCOVA model stratified by ICS dose level and region||Analysis was performed using a rank ANCOVA model stratified by ICS dose level and region.|
1609306|NCT02573181|2956402|Other|Difference in % with headache|Headache difference|-2.5|||||2-Sided|95.0|-11.4|6.4|||||Difference and 95% CI calculated based on the Miettinen & Nurminen method.||
1609307|NCT02573181|2956402|Other|Difference in % with myalgia|Myalgia difference|4.6|||||2-Sided|95.0|-3.9|13.3|||||Difference and 95% CI calculated based on the Miettinen & Nurminen method.||
1609308|NCT02573181|2956402|Other|Difference in % with arthralgia|Arthralgia difference|-3.2|||||2-Sided|95.0|-10.2|3.4|||||Difference and 95% CI calculated based on the Miettinen & Nurminen method.||
1609309|NCT02573181|2956402|Other|Difference in % with fatigue|Fatigue difference|-0.9|||||2-Sided|95.0|-10.7|8.8|||||Difference and 95% CI calculated based on the Miettinen & Nurminen method.||
1609310|NCT02573181|2956404|Other|Difference in percentage with AEs|Difference|4.2|||||2-Sided|95.0|-7.4|15.8|||||Difference and 95% CI calculated based on Miettinen & Nurminen method.||
1609311|NCT02573155|2956411|Superiority or Other||Least square mean|0.21|Standard Error of the Mean|0.0272|<|0.0001||95.0|0.156|0.264|||ANCOVA||||
1609312|NCT02573155|2956411|Superiority or Other||Least Square Mean|0.111|Standard Error of the Mean|0.0265|<|0.0001|2-Sided|95.0|0.0585|0.163|||ANCOVA||||
1609313|NCT02573012|2956416|Superiority||Least Square Means|2.264||||0.009||95.0|0.574|3.953|||ANCOVA||||
1609314|NCT02573012|2956436|Superiority||Least Square Mean|2.342||||0.006|2-Sided|95.0|0.661|4.023|||ANCOVA||||
1609315|NCT02573012|2956437|Superiority||Relative Risk|0.833||||0.021|2-Sided|95.0|0.714|0.972|||Cochran-Mantel-Haenszel||||
1609316|NCT02573012|2956437|Superiority||Odds Ratio (OR)|0.5||||0.018|2-Sided|95.0|0.285|0.889|||Regression, Logistic||||
1609317|NCT02573012|2956438|Superiority||Least Square Means|0.613||||0.001|2-Sided|95.0|0.346|0.879|||ANCOVA||||
1609318|NCT02572817|2956443|Superiority||Odds Ratio (OR)|0.47||||0.23|2-Sided|95.0|0.13|1.43|||Regression, Logistic||||
1609319|NCT02572817|2956444|Superiority||Odds Ratio (OR)|1.73||||0.12|2-Sided|95.0|0.87|3.44|||Regression, Logistic||||
1609320|NCT02572817|2956445|Superiority|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change in PELOD from baseline to Day 7|
1609321|NCT02572817|2956445|Superiority|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Change in PELOD from baseline to Day 3|
1609322|NCT02572817|2956446|Superiority||Hodges-Lehman estimate of location shift|-1.0||||0.13|2-Sided|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in SOFA from baseline to Day 7|
1609323|NCT02572817|2956446|Superiority||Hodges-Lehman estimate of location shift|0.0||||0.06|2-Sided|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in SOFA from baseline to Day 3|
1609324|NCT02572817|2956447|Superiority|||||||1|||||||Fisher Exact||||
1609325|NCT02572817|2956449|Superiority||Odds Ratio (OR)|0.33||||0.24|2-Sided|95.0|0.05|1.79|||Regression, Logistic||||
1609326|NCT02572817|2956451|Superiority||Odds Ratio (OR)|0.74||||1|2-Sided|95.0|0.08|9.29|||Regression, Logistic||||
1609327|NCT02572817|2956452|Superiority||Hodges-Lehman estimate of location shift|-3.0||||0.22|2-Sided|95.0|-14.0|2.0|||Wilcoxon (Mann-Whitney)||||
1609328|NCT02572817|2956453|Superiority|||||||0.55|||||||Fisher Exact||||
1609334|NCT02572817|2956458|Superiority||Hodges-Lehman estimate of location shift|0.0||||0.66|2-Sided|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||Change in NEW from baseline to Day 3|
1609335|NCT02572817|2956458|Superiority||Hodges-Lehman estimate of location shift|-1.0||||0.2|2-Sided|95.0|-2.0|0.0|||Wilcoxon (Mann-Whitney)|||Change in NEW from baseline to Day 3|
1609336|NCT02572817|2956459|Superiority||Odds Ratio (OR)|1.65||||0.29|2-Sided|95.0|0.66|4.12|||Regression, Logistic|||Composite mortality and hospitalization, Day 28|
1609337|NCT02572817|2956459|Superiority||Odds Ratio (OR)|1.11||||0.79|2-Sided|95.0|0.5|2.48|||Regression, Logistic|||Composite mortality and hospitalization, Day 14|
1609338|NCT02572817|2956459|Superiority||Odds Ratio (OR)|1.33||||0.43|2-Sided|95.0|0.65|2.71|||Regression, Logistic|||Composite mortality and hospitalization, Day 7|
1609339|NCT02572817|2956460|Superiority|||||||0.69|||||||Fisher Exact||||
1609340|NCT02572817|2956461|Superiority||Hazard Ratio (HR)|0.74||||0.64|2-Sided|95.0|0.21|2.64|||Log Rank||||
1609341|NCT02572817|2956462|Superiority|||||||0.3|||||||Wilcoxon (Mann-Whitney)||||
1609342|NCT02572817|2956463|Superiority||Odds Ratio (OR)|1.29||||0.47|2-Sided|95.0|0.65|2.56|||Regression, Logistic||||
1609343|NCT02572817|2956464|Superiority||Odds Ratio (OR)|1.07||||0.83|2-Sided|95.0|0.55|2.08|||Regression, Logistic||||
1609344|NCT02572817|2956465|Superiority||Odds Ratio (OR)|1.26||||0.49|2-Sided|95.0|0.65|2.41|||Regression, Logistic||||
1609345|NCT02572817|2956466|Superiority||Odds Ratio (OR)|0.95||||0.87|2-Sided|95.0|0.5|1.8|||Regression, Logistic||||
1609346|NCT02572817|2956467|Superiority||Odds Ratio (OR)|0.86||||0.66|2-Sided|95.0|0.45|1.66|||Regression, Logistic||||
1609347|NCT02572817|2956468|Superiority||Odds Ratio (OR)|1.22||||0.54|2-Sided|95.0|0.65|2.29|||Regression, Logistic||||
1609348|NCT02572752|2956469|Superiority or Other||gMean Ratio|97.149|Standard Deviation|11.4|<|0.0001|2-Sided|90.0|94.223|100.166|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 & R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An ANOVA model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed|
1609349|NCT02572752|2956470|Superiority or Other||gMean Ratio|97.004|Standard Error of the Mean|20.77|<|0.0001|2-Sided|90.0|90.948|103.463|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 & R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An ANOVA model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed.|
1609350|NCT02572752|2956471|Superiority or Other||gMean Ratio|97.478|Standard Error of the Mean|11.57|<|0.0001|2-Sided|90.0|94.545|100.502|||ANOVA||Relative bioavailability was estimated by the ratios of the gMean of nin Test treatment (T) divided by nin Reference treatment (R1 & R2). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment (without differentiation between R1 and R2). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. For the two 1-sided t-test procedure, the effect 'subjects within sequences' was considered to be random, whereas the other effects were considered to be fixed|
1609351|NCT02572609|2956472|Non-Inferiority or Equivalence|Bioequivalence in the AUC0-t will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|T/R Ratio|119.61|Standard Deviation|10.65||0.0438|2-Sided|90.0|114.65|124.79|||Anderson-Hauck procedure||Standard Deviation is actually the Coefficient of variation intra subject (CVintra).||
1609352|NCT02572609|2956473|Non-Inferiority or Equivalence|Bioequivalence in the Cmax will be concluded if the 90% confidence interval for the test/reference ratio of the least squares means is fully contained within the acceptance range, 80.00% - 125.00%.|T/R Ratio|113.56|Standard Deviation|16.24||0.0082|2-Sided|90.0|106.48|121.1|||Anderson-Hauck procedure||Standard Deviation is actually the Coefficient of variation intra subject (CVintra).||
1609353|NCT02572427|2956474|Superiority or Other|||||||0.001|||||||t-test, 2 sided||||
1609354|NCT02572427|2956475|Superiority or Other|||||||0.039|||||||t-test, 2 sided||||
1609355|NCT02572401|2956476|Superiority||Mean Difference (Final Values)|-0.009|||<|0.05|2-Sided|95.0|-0.167|0.149|||Regression, Linear|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.||The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.|
1609356|NCT02572401|2956476|Superiority||Mean Difference (Final Values)|-0.003|||<|0.05|2-Sided|95.0|-0.082|0.076|||Regression, Linear|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.|
1609357|NCT02572401|2956476|Superiority||Mean Difference (Final Values)|0.001|||<|0.05|2-Sided|95.0|-0.078|0.08|||Regression, Linear|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.|
1609453|NCT02566135|2956864|Other|||||||0.22|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following induction of anaesrthesia between group I and group C.|
1609358|NCT02572401|2956477|Superiority||Risk Ratio (RR)|1.02|||<|0.05|2-Sided|95.0|0.5|2.08|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.|
1609359|NCT02572401|2956477|Superiority||Risk Ratio (RR)|1.01|||<|0.05|2-Sided|95.0|0.71|1.45|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.|
1609360|NCT02572401|2956477|Superiority||Risk Ratio (RR)|1.04|||<|0.05|2-Sided|95.0|0.73|1.48|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.|
1609361|NCT02572401|2956478|Superiority||Risk Ratio (RR)|1.05|||<|0.05|2-Sided|95.0|0.76|1.47|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.|
1609362|NCT02572401|2956478|Superiority||Risk Ratio (RR)|1.1|||<|0.05|2-Sided|95.0|0.94|1.3|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).||This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.|The numerator is the treatment.
1609363|NCT02572401|2956478|Superiority||Risk Ratio (RR)|1.05|||<|0.05|2-Sided|95.0|0.89|1.24|||Poisson regression|Adjusted for baseline of the criterion.|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.|
1609364|NCT02572401|2956479|Superiority||Risk Ratio (RR)|1.1|||<|0.05|2-Sided|95.0|0.86|1.42|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.|
1609365|NCT02572401|2956479|Superiority||Risk Ratio (RR)|1.02|||<|0.05|2-Sided|95.0|0.9|1.16|||Poisson regression|Adjusted for baseline of the criterion.|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.|
1609366|NCT02572401|2956479|Superiority||Risk Ratio (RR)|1.04|||<|0.05|2-Sided|95.0|0.92|1.18|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.|
1609367|NCT02572401|2956480|Superiority||Risk Ratio (RR)|0.72|||<|0.05|2-Sided|95.0|0.35|1.49|||Poisson regression|Adjusted for baseline of the criterion, time of follow-up assessment (6 vs. 12 months), and the HIV x Time and Text Messaging x Time interactions.|The numerator is the treatment.|The analysis tested whether text messaging enhanced the effects of the HIV risk reduction intervention by comparing the HIV Risk Reduction and Text Messaging and No-Intervention No Text Message Arms to the Text Messaging Only and HIV Risk Reduction Only Arms. This is a test of the interaction between the two types of interventions.|
1609368|NCT02572401|2956480|Superiority||Risk Ratio (RR)|0.99|||<|0.05|2-Sided|95.0|0.69|1.42|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|This analysis tested the efficacy of the text messaging intervention by comparing the HIV Risk Reduction and Text Messaging and Text Messaging Only Arms to the HIV Risk Reduction Only and No-Intervention No Text Message Control Arms. This is a test of the text messaging main effect.|
1609369|NCT02572401|2956480|Superiority||Risk Ratio (RR)|0.84|||<|0.05|2-Sided|95.0|0.59|1.21|||Poisson regression|Adjusted for baseline of the criterion and time of follow-up assessment (6 vs. 12 months).|The numerator is the treatment.|The primary analysis tested the efficacy of the HIV risk reduction intervention by comparing the HIV Risk Reduction Only and HIV Risk Reduction and Text Messaging Arms to the Text Messaging Only and No-Intervention No Text Message Control Arms. This is a test of the main effect of the HIV risk reduction intervention.|
1609370|NCT02572076|2956491|Other|Pilot study- no sample size was calculated|number of subjects with adequate cleansi|100.0|||||2-Sided|95.0|66.0|100.0||||||patients had partial bowel preparation to mimic poor bowel cleansing before the colonoscopy procedure at baseline, MCS was used during the procedure to clean the colon.|
1609371|NCT02571452|2956501|Superiority||Mean Difference (Net)|-0.66|Standard Error of the Mean|0.49||0.173|2-Sided|95.0|-1.61|0.29||The threshold for statistical significance was p=.05.|Mixed Models Analysis||||
1609455|NCT02566135|2956864|Other|||||||0.34|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared at base line between group I and group C.|
1609372|NCT02571452|2956502|Superiority||Mean Difference (Net)|-4.1|Standard Error of the Mean|0.89|<|0.001|2-Sided|95.0|-5.87|-2.33||The threshold for statistical significance was p=.05.|Mixed Models Analysis||||
1609373|NCT02571452|2956503|Superiority||Mean Difference (Net)|0.52|Standard Error of the Mean|0.57||0.568|2-Sided|95.0|-1.26|2.3||The threshold for statistical significance was p=.05.|Mixed Models Analysis||||
1609374|NCT02571452|2956504|Superiority||Mean Difference (Net)|-3.6|Standard Error of the Mean|1.53||0.021|2-Sided|95.0|-6.65|-0.55||The threshold for statistical significance was p=.05.|Mixed Models Analysis||||
1609375|NCT02571439|2956505|Other|||||||0.91|||||||Kruskal-Wallis||||
1609376|NCT02571439|2956506|Other|||||||0.27|||||||Chi-squared||||
1609377|NCT02571439|2956507|Other|||||||0.87|||||||Kruskal-Wallis||||
1609378|NCT02571439|2956508|Other|||||||0.17|||||||Kruskal-Wallis||||
1609379|NCT02571439|2956509|Other|||||||0.13|||||||Kruskal-Wallis||||
1609380|NCT02571439|2956510|Other|||||||0.33|||||||Kruskal-Wallis||||
1609381|NCT02571439|2956511|Other|||||||0.46|||||||Kruskal-Wallis||||
1609382|NCT02571439|2956512|Other|||||||0.61|||||||Kruskal-Wallis||||
1609383|NCT02571439|2956513|Other||||||<|0.001|||||||t-test, 2 sided||||
1609384|NCT02571439|2956514|Other||||||<|0.001|||||||t-test, 2 sided||||
1609385|NCT02571244|2956515|Superiority||Risk Ratio (RR)|1.44|||||2-Sided|95.0|1.07|1.92|||||||
1609386|NCT02571244|2956516|Superiority||Risk Ratio (RR)|1.45|||||2-Sided|95.0|1.08|1.95|||||||
1609387|NCT02571244|2956517|Superiority|||||||0.42|||||||Fisher Exact||||
1609388|NCT02571244|2956518|Superiority|||||||0.28|||||||t-test, 2 sided||||
1609389|NCT02571244|2956519|Superiority||Risk Ratio (RR)|1.35|||||2-Sided|95.0|0.99|1.85|||||||
1609390|NCT02570165|2956571|Superiority or Other||Mean Difference (Final Values)|211.1|||||2-Sided|95.0|138.6|283.7|||||The 95% confidence interval for the difference between 600 µg Batefenterol and Placebo was estimated.||
1609391|NCT02570165|2956571|Superiority or Other||Mean Difference (Final Values)|208.9|||||2-Sided|95.0|138.7|279.2|||||The 95% confidence interval for the difference between 300 µg Batefenterol and Placebo was estimated.||
1609392|NCT02570165|2956571|Superiority or Other||Mean Difference (Final Values)|204.6|||||2-Sided|95.0|137.2|272.1|||||The 95% confidence interval for the difference between 150 µg Batefenterol and Placebo was estimated.||
1609393|NCT02570165|2956571|Superiority or Other||Mean Difference (Final Values)|196.6|||||2-Sided|95.0|128.4|264.8|||||The 95% confidence interval for the difference between 75 µg Batefenterol and Placebo was estimated.||
1609394|NCT02570165|2956571|Superiority or Other||Mean Difference (Final Values)|182.2|||||2-Sided|95.0|99.8|264.6|||||The 95% confidence interval for the difference between 37.5 µg Batefenterol and Placebo was estimated.||
1609395|NCT02570165|2956572|Superiority or Other||Mean Difference (Final Values)|292.8|||||2-Sided|95.0|223.02|364.42|||||The 95% Bayesian credible interval for differences between each individual batefenterol 600 µg dose and placebo was estimated.||
1609396|NCT02570165|2956572|Superiority or Other||Mean Difference (Final Values)|281.4|||||2-Sided|95.0|212.35|351.3|||||The 95% Bayesian credible interval for differences between each individual batefenterol 300 µg dose and placebo was estimated.||
1609397|NCT02570165|2956572|Superiority or Other||Mean Difference (Final Values)|261.8|||||2-Sided|95.0|189.85|332.25|||||The 95% Bayesian credible interval for differences between each individual batefenterol 150 µg dose and placebo was estimated.||
1609398|NCT02570165|2956572|Superiority or Other||Mean Difference (Final Values)|231.6|||||2-Sided|95.0|149.31|310.02|||||The 95% Bayesian credible interval for differences between each individual batefenterol 75 µg dose and placebo was estimated.||
1609399|NCT02570165|2956572|Superiority or Other||Mean Difference (Final Values)|191.1|||||2-Sided|95.0|101.07|284.26|||||The 95% Bayesian credible interval for the mean difference between batefenterol 37.5 µg dose and placebo (batefenterol 37.5 µg minus placebo) was estimated.||
1609400|NCT02570126|2956586|Non-Inferiority|Criterion for the Varilrix HSA-free vaccine as compared to Varilrix™ vaccine, the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (VAR_HSA_F minus VAR) in incidence of fever > 39.0°C (> 102.2°F) within 0-14 days after Dose 1 was to be equal to or below 5%|Difference in percentage between groups|-1.29|||||2-Sided|95.0|-3.72|1.08|||||Power obtained using PASS 2005 (Likelihood Score [Miettinen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=2.5%|Non-inferiority of Varilrix HSA-free vaccine to Varilrix™ vaccine in terms of percentage of subjects reporting fever > 39.0°C (> 102.2°F) within 15-days (Days 0-14) after Dose 1 (VAR_HSA_F Group minus VAR Group)|
1609401|NCT02570022|2956615|Superiority or Other||Mean Difference (Final Values)|0.05|||<|0.05|2-Sided||||||t-test, 2 sided||This analysis corresponds to the visual analog scale and morphine equivalent data.|Our hypothesis was that in patients undergoing shoulder arthroplasty, treatment with LB would lead to no significant differences in average daily pain scores. A power analysis was performed prior to the study to assess the primary hypothesis that a significant difference in average daily pain of 13mm on VAS will not be found between the INB and LB groups. With a power of 80% (beta level = 0.80, alpha level = 0.05), a sample size of 25 patients per group was obtained|
1609402|NCT02569112|2956707|Superiority|A significant improvement in skin laxity reduction is defined as a mean average increase in grade of 1 as per the GAIS.|||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Used Wilcoxon Matched-Pairs Signed-Ranks test||The null hypothesis was that the addition of the multipolar radiofrequency with varipulse technology treatment to the cryolipolysis treatment would not show visual improvement.|
1609403|NCT02568345|2956747|Superiority or Other||isotonic regression functions through PA|2.2|||||2-Sided||||||||||
1609404|NCT02567968|2956766|Superiority|||||||0.002|||||||paired t-test||||
1609405|NCT02567708|2956775|Other||Posterior median ratio|1.0|Standard Deviation|0.085||0.51|2-Sided|95.0|0.84|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than one.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.||
1609406|NCT02567708|2956775|Other||Posterior median ratio|0.95|Standard Deviation|0.071||0.76|2-Sided|95.0|0.83|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.||
1609407|NCT02567708|2956775|Other||Posterior median ratio|0.89|Standard Deviation|0.063||0.97|2-Sided|95.0|0.78|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median ratio is calculated as GSK2269557 1000 μg/ Placebo.||
1609408|NCT02567708|2956778|Other||Posterior median difference|0.5|Standard Deviation|0.59||0.81|2-Sided|95.0|-0.6|1.7||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.||
1609409|NCT02567708|2956779|Other||Posterior median difference|-0.113|Standard Deviation|0.5148||0.41|2-Sided|95.0|-1.125|0.908||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo..||
1609410|NCT02567708|2956779|Other||Posterior median difference|0.014|Standard Deviation|0.6672||0.51|2-Sided|95.0|-1.271|1.341||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.||
1609411|NCT02567708|2956779|Other||Posterior median difference|0.083|Standard Deviation|0.6175||0.56|2-Sided|95.0|-1.102|1.346||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.||
1609412|NCT02567708|2956780|Other||Posterior median difference|0.038|Standard Deviation|0.0559||0.76|2-Sided|95.0|-0.073|0.148||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 28. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.||
1609413|NCT02567708|2956780|Other||Posterior median difference|0.04|Standard Deviation|0.0578||0.76|2-Sided|95.0|-0.071|0.156||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.||
1609414|NCT02567708|2956780|Other||Posterior median difference|-0.021|Standard Deviation|0.0609||0.35|2-Sided|95.0|-0.14|0.099||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.||
1609415|NCT02567708|2956781|Other||Posterior median difference|0.024|Standard Deviation|0.057||0.66|2-Sided|95.0|-0.087|0.137||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 14. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.||
1609416|NCT02567708|2956781|Other||Posterior median difference|-0.009|Standard Deviation|0.0712||0.44|2-Sided|95.0|-0.151|0.131||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|Day 7. The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.||
1609417|NCT02567708|2956782|Other|The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Posterior median difference|0.05|Standard Deviation|0.0818||0.731|2-Sided|95.0|-0.111|0.21|||Bayesian model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.||
1609418|NCT02567708|2956783|Other||Posterior median difference.|0.013|Standard Deviation|0.0501||0.61|2-Sided|95.0|-0.084|0.113||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.||
1609454|NCT02566135|2956864|Other|||||||0.27|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.|
1609419|NCT02567708|2956784|Other||Posterior median difference.|0.007|Standard Deviation|0.0468||0.57|2-Sided|95.0|-0.083|0.102||The data entered for the p-value represents the posterior probability that the true treatment difference is greater than zero.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted.|The data entered as the 95% confidence interval represents the 95% equi-tailed credible interval. The posterior median difference is calculated as GSK2269557 1000 μg minus Placebo.||
1609420|NCT02567552|2956790|Other|||||||0.5|||||||Fisher Exact||||
1609421|NCT02567552|2956791|Other|||||||0.3107|||||||t-test, 2 sided||||
1609422|NCT02567552|2956792|Other||||||<|0.0001|||||||t-test, 2 sided||||
1609423|NCT02567552|2956793|Other|||||||0.8371|||||||t-test, 2 sided||||
1609424|NCT02567552|2956794|Other|||||||0.5118|||||||t-test, 2 sided||||
1609425|NCT02567552|2956795|Other|||||||0.2301|||||||t-test, 2 sided||||
1609426|NCT02567552|2956796|Other|||||||0.6262|||||||t-test, 2 sided||||
1609427|NCT02567552|2956797|Other|||||||0.2042|||||||t-test, 2 sided||||
1609428|NCT02567552|2956799|Other|||||||0.1189|||||||t-test, 2 sided|||comparison between groups|
1609429|NCT02567552|2956800|Other|||||||0.1523|||||||Chi-squared||||
1609430|NCT02567552|2956801|Other|||||||0.3395|||||||Chi-squared||||
1609431|NCT02566759|2956832|Superiority or Other||LS Mean Ratio|2.336|||||2-Sided|90.0|1.9592|2.7854||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.|
1609432|NCT02566759|2956832|Superiority or Other||LS Mean Ratio|0.543|||||2-Sided|90.0|0.4797|0.6149||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.|
1609433|NCT02566759|2956832|Superiority or Other||Slope|0.8415|||<|0.001|2-Sided|90.0|0.7618|0.9212|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.|
1609434|NCT02566759|2956832|Superiority or Other||Slope|0.8505|||<|0.001|2-Sided|90.0|0.7925|0.9084|||Power model|||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.|
1609435|NCT02566759|2956833|Superiority or Other||LS Mean Ratio|2.563|||||2-Sided|90.0|2.1|3.1275||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.|
1609436|NCT02566759|2956833|Superiority or Other||LS Mean Ratio|0.5|||||2-Sided|90.0|0.4324|0.5777||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.|
1609437|NCT02566759|2956833|Superiority or Other||Slope|0.9135|||||2-Sided|90.0|0.8062|1.0209||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.|
1609438|NCT02566759|2956833|Superiority or Other||Slope|0.872|||||2-Sided|90.0|0.8145|0.9296||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 % CI of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.|
1609439|NCT02566759|2956836|Superiority or Other||LS Mean Ratio|1.799|||||2-Sided|90.0|1.4625|2.2116||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed LS Means.|
1609440|NCT02566759|2956836|Superiority or Other||Least Square (LS) Mean Ratio|0.362|||||2-Sided|90.0|0.3043|0.4301||||||The point estimate and CI were obtained by taking the antilog of the difference in the log transformed lease square (LS) Means.|
1609441|NCT02566759|2956836|Superiority or Other||Slope|0.7795|||||2-Sided|90.0|0.6597|0.8993||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) = a+b*ln (dose), where a and b were the intercept and slope of the line, respectively. Dose proportionality was declared when the 90% CI of the slope lies entirely within the critical region (0.9139, 1.0861) for the dose range of 30 mg to 400 mg.|
1609442|NCT02566759|2956836|Superiority or Other||Slope|0.6662|||||2-Sided|90.0|0.5969|0.7355||||||Dose proportionality was evaluated using the following power model: ln (PK Parameter) is equal to (=) a+b*ln (dose), where a and b are the intercept and slope of the line, respectively. Dose proportionality was declared when the 90 percent (%) confidence interval (CI) of the slope lies entirely within the critical region (0.9483, 1.0517) for the dose range of 10 mg to 750 mg.|
1609443|NCT02566135|2956862|Other||||||<|0.0001|||||||t-test, 2 sided||||
1609444|NCT02566135|2956863|Other||||||<|0.0001|||||||t-test, 2 sided|||We had compared time of insertion for supraglottic airway between group I and group C.|
1609445|NCT02566135|2956864|Other|||||||0.81|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 15 minutes after endotracheal tube insertion between group I and group C.|
1609446|NCT02566135|2956864|Other|||||||0.69|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 10 minutes after endotracheal tube insertion between group I and group C.|
1609447|NCT02566135|2956864|Other|||||||0.76|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 7 minutes after endotracheal tube insertion between group I and group C.|
1609448|NCT02566135|2956864|Other|||||||0.49|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 5 minutes after endotracheal tube insertion between group I and group C.|
1609449|NCT02566135|2956864|Other|||||||0.49|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared 3 minutes after endotracheal tube insertion between group I and group C.|
1609450|NCT02566135|2956864|Other|||||||0.55|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared the time of endotracheal tube insertion between group I and group C.|
1609451|NCT02566135|2956864|Other|||||||0.71|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.|
1609452|NCT02566135|2956864|Other|||||||0.96|||||||t-test, 2 sided|||Diastolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.|
1609456|NCT02566135|2956865|Other|||||||0.49|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 15 minutes after ETT insertion between group I and group C.|
1609457|NCT02566135|2956865|Other|||||||0.98|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 10 minutes after ETT insertion between group I and group C.|
1609458|NCT02566135|2956865|Other|||||||0.68|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 7 minutes after ETT insertion between group I and group C.|
1609459|NCT02566135|2956865|Other|||||||0.86|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 5 minutes after ETT insertion between group I and group C.|
1609460|NCT02566135|2956865|Other|||||||0.2|||||||t-test, 2 sided|||Systolic blood pressure measured and compared 3 minutes after ETT insertion between group I and group C.|
1609461|NCT02566135|2956865|Other|||||||0.71|||||||t-test, 2 sided|||Systolic blood pressure measured and compared at ETT insertion time between group I and group C.|
1609462|NCT02566135|2956865|Other|||||||0.055|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following ventilating bougie insertion between group I and group C.|
1609463|NCT02566135|2956865|Other|||||||0.85|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following supraglottic airway insertion between group I and group C.|
1609464|NCT02566135|2956865|Other|||||||0.07|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following induction os anaesthesia between group I and group C.|
1609465|NCT02566135|2956865|Other|||||||0.11|||||||t-test, 2 sided|||Systolic blood pressure measured and compared following Dexmedetomidine injection between group I and group C.|
1609466|NCT02566135|2956865|Other|||||||0.24|||||||t-test, 2 sided|||Systolic blood pressure measured and compared at base line between group I and group C.|
1609467|NCT02566135|2956866|Other|||||||0.49|||||||t-test, 2 sided|||Heart rate beats per minute measured after 15 minute of ETT insertion among the group I and group C.|
1609468|NCT02566135|2956866|Other|||||||0.98|||||||t-test, 2 sided|||Heart rate beats per minute measured after 10 minute of ETT insertion among the group I and group C.|
1609469|NCT02566135|2956866|Other|||||||0.18|||||||t-test, 2 sided|||Heart rate beats per minute measured after 7 minute of ETT insertion among the group I and group C.|
1609470|NCT02566135|2956866|Other|||||||0.29|||||||t-test, 2 sided|||Heart rate beats per minute measured after 5 minute of ETT insertion among the group I and group C.|
1609471|NCT02566135|2956866|Other|||||||0.63|||||||t-test, 2 sided|||Heart rate beats per minute measured after 3 minute of ETT insertion among the group I and group C.|
1609472|NCT02566135|2956866|Other||||||>|0.33|||||||t-test, 2 sided|||Heart rate beats per minute measured at endotracheal intubation among the group I and group C.|
1609473|NCT02566135|2956866|Other||||||>|0.059|||||||t-test, 2 sided|||Heart rate beats per minute measured following ventilating bougie insertion among the group I and group C.|
1609474|NCT02566135|2956866|Other||||||>|0.22|||||||t-test, 2 sided|||Heart rate beats per minute measured following supraglottic airway insertion among the group I and group C.|
1609475|NCT02566135|2956866|Other||||||>|0.16|||||||t-test, 2 sided|||Heart rate beats per minute measured following induction of anaesthesia among the group I and group C.|
1609476|NCT02566135|2956866|Other||||||>|0.58|||||||t-test, 2 sided|||Heart rate beats per minute is measured following Dexmedetomidine injection among the group I and group C.|
1609477|NCT02566135|2956866|Other||||||>|0.44|||||||t-test, 2 sided|||Heart rate beats per minute measured at base line among the group I and group C.|
1609478|NCT02566135|2956867|Other||||||>|0.05|||||||Chi-squared, Corrected||||
1609479|NCT02566135|2956868|Other||Risk Ratio (RR)|0.8972|||>|0.05|2-Sided|95.0|0.4858|1.6569|||Chi-squared, Corrected|||We had applied chi square to see the statistical significant difference between group I and group C for number of attempt for ventilating bougie insertion.|
1609480|NCT02566135|2956869|Other||Risk Ratio (RR)|1.4628||||0.5033|2-Sided|95.0|0.6401|3.3428|||Chi-squared, Corrected|||Chi square test was applied to see weather there is a statistical significant difference between group I and group C for attempt for supraglottic airway insertion.|
1609481|NCT02566109|2956874|Other|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.98432||||0.1129|2-Sided||||||Pearson Correlation Coefficient||||
1609482|NCT02566109|2956875|Other|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.99696||||0.0497|2-Sided||||||Pearson Correlation Coefficient|||Correlation between baseline and 6 months.|
1609483|NCT02566109|2956875|Other|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.10327||||0.9341|2-Sided||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.|
1609484|NCT02566109|2956876|Other|Pearson Correlation Coefficient|Pearson Correlation Coefficient|0.97287||||0.1486|2-Sided||||||Pearson Correlation Coefficient|||Correlation between baseline and 6 months.|
1609485|NCT02566109|2956876|Other|Pearson Correlation Coefficient|Pearson Correlation Coefficient|-0.09487||||0.9395|2-Sided||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.|
1609486|NCT02566109|2956877|Other|Correlation|Pearson Correlation Coefficient|0.25733||||0.8343|2-Sided||||||Peason Correlation Coefficient|||Correlation between baseline and 6 months.|
1609487|NCT02566109|2956877|Other|Estimation of Pearson correlation|Pearson Correlation Coefficient|-0.57472||||0.6102|2-Sided||||||Pearson Correlation Coefficient|||Correlation between baseline and 2 months.|
1609488|NCT02566031|2956887|Superiority||Mean Difference (Net)|-0.81||||0.1008|2-Sided|95.0|-1.77|0.16|||ANCOVA||||
1609489|NCT02566031|2956888|Superiority||Mean Difference (Net)|0.31||||0.0767|2-Sided|95.0|-0.033|0.646|||ANCOVA||||
1609490|NCT02566031|2956889|Superiority||Mean Difference (Net)|0.05||||0.0161|2-Sided|95.0|0.009|0.091|||ANCOVA|||-15min|
1609491|NCT02566031|2956889|Superiority||Mean Difference (Net)|0.06||||0.0058|2-Sided|95.0|0.017|0.098|||ANCOVA|||-45 min|
1609492|NCT02566031|2956890|Superiority||Mean Difference (Net)|0.05||||0.0129|2-Sided|95.0|0.011|0.093|||ANCOVA||||
1609493|NCT02565628|2956940|Superiority or Other||Least Square Mean Difference|-5.02|Standard Error of the Mean|10.49||0.6382|1-Sided|90.0||8.97|||Mixed Models Analysis||||
1609523|NCT02564055|2957095|Other||Difference in percentages|-3.3|||||2-Sided|95.0|-46.0|42.3|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.||
1610441|NCT02553629|2957982|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1609494|NCT02565576|2956975|Superiority||estimate of contrast posterior median|-1.14|||||2-Sided|90.0|-3.41|1.14||||||Primary analysis was performed on the PD analysis set. Changes from baseline in QMG scores at Week 25 were analyzed using a Bayesian model. The model investigated effects for treatment (CFZ533 or placebo) and baseline QMG score. A difference of 3 points on the mean change in QMG score between CFZ533 and placebo was deemed a clinical meaningful effect.|
1609495|NCT02565147|2956999|Superiority|||||||0.7505|||||||Wilcoxon Rank Sum Test||||
1609496|NCT02564926|2957007|Other||LS mean difference (%)|-1.94|||<|0.001|2-Sided|95.0|-2.807|-1.082|||ANCOVA||||
1609497|NCT02564926|2957008|Other||LS mean difference (mg/L)|-0.12||||0.756|2-Sided|95.0|-0.858|0.625|||ANCOVA||||
1609498|NCT02564926|2957009|Other||LS mean difference (ng/mL)|657.71||||0.044|2-Sided|95.0|18.325|1297.101|||ANCOVA||||
1609499|NCT02564926|2957010|Other||LS mean difference|-1.3|||<|0.001|2-Sided|95.0|-1.992|-0.54|||ANCOVA||||
1609500|NCT02564926|2957011|Other||LS mean difference|-0.03||||0.503|2-Sided|95.0|-0.127|0.063|||ANCOVA||||
1609501|NCT02564926|2957012|Other||LS mean difference (cm2)|-18.39|||<|0.001|2-Sided|95.0|-27.561|-9.218|||ANCOVA||||
1609502|NCT02564926|2957013|Other||LS mean difference (cm2)|-17.55||||0.002|2-Sided|95.0|-28.603|-6.489|||ANCOVA||||
1609503|NCT02564926|2957014|Other||LS mean difference (mmHg)|-2.61||||0.11|2-Sided|95.0|-5.829|0.6|||Mixed Models Analysis||||
1609504|NCT02564926|2957015|Other||LS mean difference (mmHg)|-6.81||||0.002|2-Sided|95.0|-10.969|-2.641|||Mixed Models Analysis||||
1609505|NCT02564926|2957016|Other||LS mean difference (kg/m2)|-1.37|||<|0.001|2-Sided|95.0|-1.742|-0.99|||Mixed Models Analysis||||
1609506|NCT02564926|2957017|Other||LS mean difference (cm)|-2.21||||0.006|2-Sided|95.0|-3.785|-0.635|||Mixed Models Analysis||||
1609507|NCT02564926|2957018|Other||LS mean difference (kg)|-3.7|||<|0.001|2-Sided|95.0|-4.667|-2.631|||Mixed Models Analysis||||
1609508|NCT02564926|2957019|Other||LS mean difference (mg/dL)|-18.25||||0.006|2-Sided|95.0|-31.14|-5.351|||Mixed Models Analysis||||
1609509|NCT02564926|2957020|Other||Odds Ratio (OR)|1.45||||0.343|2-Sided|95.0|0.673|3.113|||Regression, Logistic||||
1609510|NCT02564926|2957021|Other||LS mean difference (%)|-0.46||||0.014|2-Sided|95.0|-0.821|-0.094|||Mixed Models Analysis||||
1609511|NCT02564926|2957022|Other||LS mean difference (kg)|-2.6|||<|0.001|2-Sided|95.0|-3.346|-1.819|||ANCOVA||||
1609512|NCT02564432|2957049|Other|"In this study, dissimilarities between the stomal and healthy thigh skins were tested.~Observational study. Used only for visualizing trends in the data."|PERMANOVA|0.001|||<|0.005|2-Sided|||||Each stomal community type was distinguished by both its diversity and taxonomic composition|Bray–Curtis dissimilarities|Nonmetric multidimensional scaling (NMDS) of Bray–Curtis dissimilarities|||Loess Regression was used to visualize temporal trends in the Shannnon Diversity and relative abundance of microbes (Staphylococcus, Streptococcus, Corynebacterium, and obligate anaerobes).
1609513|NCT02564432|2957049|Equivalence|This is not a randomized clinical trial but is an observational study, each patient's thigh skin site served as the control.|Base mean abundance|0.03|||<|0.05|2-Sided|||||The reported p-value was calculated.|Unweighted UniFrac (qualitative)|Both weighted and unweighted UniFrac were calculated; weighted UniFrac is calculated to be p = 0.398 while unweighted UniFrac was P<0.03|Differential abundance of Staphylococcus aureus in the stoma calculated by Log2 fold change (y‐axis) versus base mean abundance (x‐axis)|Sample similarity was calculated using the statistical comparisons of community composition.|
1609514|NCT02564263|2957052|Superiority||Difference in Percentages|15.1||||0.0006|2-Sided|95.0|6.2|24.7||One-sided p-value for testing. H0: difference in %=0; H1: difference in %>0.|Miettinen & Nurminen method||Miettinen & Nurminen method stratified by geographic region (Asia vs RoW) & tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)||
1609515|NCT02564263|2957053|Superiority||Difference in Percentages|9.2||||0.0022|2-Sided|95.0|3.0|15.8||One-sided p-value for testing. H0: difference in %=0; H1: difference in %>0.|Miettinen & Nurminen method||Miettinen & Nurminen method stratified by geographic region (Asia vs RoW)||
1609516|NCT02564263|2957054|Superiority||Hazard Ratio (HR)|0.73||||0.015|2-Sided|95.0|0.54|0.97||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) & tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)||
1609517|NCT02564263|2957055|Superiority||Hazard Ratio (HR)|0.92||||0.216|2-Sided|95.0|0.75|1.13||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)||
1609518|NCT02564263|2957056|Superiority||Difference in Percentages|6.4||||0.0037|2-Sided|95.0|1.7|11.2||One-sided p-value for testing. H0: difference in %=0 versus; H1: difference in %>0.|Miettinen & Nurminen method||Miettinen & Nurminen method stratified by geographic region (Asia vs RoW) & tumor histology (SCC vs adenocarcinoma/Siewert type I adenocarcinoma of the EGJ)||
1609519|NCT02564263|2957057|Superiority||Hazard Ratio (HR)|1.11||||0.287|2-Sided|95.0|0.94|1.31||One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic & a weighted log-rank Fleming-Harrington (0,1) test statistic|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) & tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the EGJ)||
1609520|NCT02564263|2957058|Superiority||Hazard Ratio (HR)|0.89||||0.0531|2-Sided|95.0|0.75|1.05||One-sided p-value based on stratified maximum weighted log rank test: the maximum of the log-rank test statistic & a weighted log-rank Fleming-Harrington (0,1) test statistic|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) & tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction [EGJ])||
1609521|NCT02564263|2957059|Superiority||Hazard Ratio (HR)|0.7||||0.00855|2-Sided|95.0|0.52|0.94||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW) & tumor histology (SCC vs adenocarcinoma/Siewert type 1 adenocarcinoma of the esophagogastric junction [EGJ])||
1609522|NCT02564263|2957060|Superiority||Hazard Ratio (HR)|0.77||||0.00894|2-Sided|95.0|0.63|0.96||One-sided p-value based on stratified log-rank test|Log Rank||Cox regression model with treatment as a covariate stratified by geographic region (Asia vs RoW)||
1609524|NCT02564055|2957095|Other||Difference in percentages|8.3|||||2-Sided|95.0|-35.0|49.2|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.||
1609525|NCT02564055|2957095|Other||Difference in percentages|-1.0|||||2-Sided|95.0|-44.5|42.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.||
1609526|NCT02564055|2957095|Other||Difference in percentages|-4.4|||||2-Sided|95.0|-48.3|41.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.||
1609527|NCT02564055|2957095|Other||Difference in percentages|-5.5|||||2-Sided|95.0|-47.9|37.6|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.||
1609528|NCT02564055|2957095|Other||Difference in percentages|5.6|||||2-Sided|95.0|-37.8|47.3|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.||
1609529|NCT02564055|2957095|Other||Difference in percentages|-1.0|||||2-Sided|95.0|-44.5|42.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.||
1609530|NCT02564055|2957095|Other||Difference in percentages|-25.6|||||2-Sided|95.0|-65.3|22.4|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.||
1609531|NCT02564055|2957095|Other||Difference in percentages|-13.6|||||2-Sided|95.0|-54.0|31.2|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.||
1609532|NCT02564055|2957095|Other||Difference in percentages|6.0|||||2-Sided|95.0|-35.8|47.1|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.||
1609533|NCT02564055|2957095|Other||Difference in percentages|6.4|||||2-Sided|95.0|-35.4|48.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.||
1609534|NCT02564055|2957095|Other||Difference in percentages|9.1|||||2-Sided|95.0|-35.6|51.2|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 8 has been presented.||
1609535|NCT02564055|2957095|Other||Difference in percentages|-11.7|||||2-Sided|95.0|-51.3|30.2|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 8 has been presented.||
1609536|NCT02564055|2957095|Other||Difference in percentages|47.7|||||2-Sided|95.0|4.8|78.7|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 8 has been presented.||
1609537|NCT02564055|2957095|Other||Difference in percentages|18.3|||||2-Sided|95.0|-25.1|57.1|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 8 has been presented.||
1609538|NCT02564055|2957095|Other||Difference in percentages|9.1|||||2-Sided|95.0|-35.6|51.2|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 4 has been presented.||
1609539|NCT02564055|2957095|Other||Difference in percentages|-15.2|||||2-Sided|95.0|-53.8|23.5|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 4 has been presented.||
1609540|NCT02564055|2957095|Other||Difference in percentages|43.4|||||2-Sided|95.0|2.7|74.6|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 4 has been presented.||
1609541|NCT02564055|2957095|Other||Difference in percentages|-15.2|||||2-Sided|95.0|-53.8|23.5|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 4 has been presented.||
1609542|NCT02564055|2957095|Other||Difference in percentages|-0.9|||||2-Sided|95.0|-40.7|40.7|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 2 has been presented.||
1609543|NCT02564055|2957095|Other||Difference in percentages|-33.3|||||2-Sided|95.0|-67.4|6.1|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 2 has been presented.||
1609544|NCT02564055|2957095|Other||Difference in percentages|28.5|||||2-Sided|95.0|-13.7|63.0|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 2 has been presented.||
1609545|NCT02564055|2957095|Other||Difference in percentages|-24.2|||||2-Sided|95.0|-60.8|14.8|||||Difference between GSK2894512 1 % BID and vehicle BID at Week 2 has been presented.||
1609546|NCT02564055|2957095|Other||Difference in percentages|9.1|||||2-Sided|95.0|-32.2|48.8|||||Difference between GSK2894512 0.5 % QD and vehicle QD at Week 1 has been presented.||
1609547|NCT02564055|2957095|Other||Difference in percentages|-7.7|||||2-Sided|95.0|-46.0|32.6|||||Difference between GSK2894512 0.5 % BID and vehicle BID at Week 1 has been presented.||
1609548|NCT02564055|2957095|Other||Difference in percentages|15.4|||||2-Sided|95.0|-25.7|52.6|||||Difference between GSK2894512 1 % QD and vehicle QD at Week 1 has been presented.||
1609549|NCT02564055|2957095|Other||Difference in percentages|-7.7|||||2-Sided|95.0|-45.8|32.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.||
1609550|NCT02564055|2957102|Other||Difference in percentages|24.2|||||2-Sided|95.0|-40.3|80.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at EW has been presented.||
1609551|NCT02564055|2957102|Other||Difference in percentages|14.3|||||2-Sided|95.0|-32.2|57.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at EW has been presented.||
1609552|NCT02564055|2957102|Other||Difference in percentages|-9.1|||||2-Sided|95.0|-62.4|47.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at EW has been presented.||
1609553|NCT02564055|2957102|Other||Difference in percentages|33.3|||||2-Sided|95.0|-31.9|90.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at EW has been presented.||
1609554|NCT02564055|2957102|Other||Difference in percentages|10.9|||||2-Sided|95.0|-14.9|35.8|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 16 has been presented.||
1609555|NCT02564055|2957102|Other||Difference in percentages|16.8|||||2-Sided|95.0|-9.5|41.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.||
1609556|NCT02564055|2957102|Other||Difference in percentages|6.9|||||2-Sided|95.0|-18.7|31.7|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.||
1609557|NCT02564055|2957102|Other||Difference in percentages|2.6|||||2-Sided|95.0|-22.6|27.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.||
1609558|NCT02564055|2957102|Other||Difference in percentages|0.4|||||2-Sided|95.0|-25.6|25.6|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.||
1609559|NCT02564055|2957102|Other||Difference in percentages|27.0|||||2-Sided|95.0|0.7|50.5|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.||
1609560|NCT02564055|2957102|Other||Difference in percentages|12.6|||||2-Sided|95.0|-13.4|37.3|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.||
1609561|NCT02564055|2957102|Other||Difference in percentages|9.3|||||2-Sided|95.0|-16.2|33.8|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.||
1609562|NCT02564055|2957102|Other||Difference in percentages|5.7|||||2-Sided|95.0|-20.1|30.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.||
1609563|NCT02564055|2957102|Other||Difference in percentages|29.5|||||2-Sided|95.0|3.7|52.3|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.||
1609564|NCT02564055|2957102|Other||Difference in percentages|16.8|||||2-Sided|95.0|-9.0|40.7|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.||
1609565|NCT02564055|2957102|Other||Difference in percentages|27.4|||||2-Sided|95.0|2.5|49.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.||
1609566|NCT02564055|2957102|Other||Difference in percentages|10.9|||||2-Sided|95.0|-13.5|34.7|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 8 has been presented.||
1609567|NCT02564055|2957102|Other||Difference in percentages|21.9|||||2-Sided|95.0|-3.0|44.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 8 has been presented.||
1609568|NCT02564055|2957102|Other||Difference in percentages|30.8|||||2-Sided|95.0|6.1|52.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 8 has been presented.||
1609569|NCT02564055|2957102|Other||Difference in percentages|13.4|||||2-Sided|95.0|-11.3|36.5|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 8 has been presented.||
1609570|NCT02564055|2957102|Other||Difference in percentages|16.3|||||2-Sided|95.0|-7.3|38.3|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 4 has been presented.||
1609571|NCT02564055|2957102|Other||Difference in percentages|8.9|||||2-Sided|95.0|-14.9|32.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 4 has been presented.||
1609572|NCT02564055|2957102|Other||Difference in percentages|41.9|||||2-Sided|95.0|19.2|61.2|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 4 has been presented.||
1609573|NCT02564055|2957102|Other||Difference in percentages|16.8|||||2-Sided|95.0|-7.1|39.4|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 4 has been presented.||
1609574|NCT02564055|2957102|Other||Difference in percentages|17.4|||||2-Sided|95.0|-6.0|39.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 2 has been presented.||
1609575|NCT02564055|2957102|Other||Difference in percentages|3.7|||||2-Sided|95.0|-19.4|26.6|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 2 has been presented.||
1609576|NCT02564055|2957102|Other||Difference in percentages|30.2|||||2-Sided|95.0|6.8|51.0|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 2 has been presented.||
1609577|NCT02564055|2957102|Other||Difference in percentages|11.4|||||2-Sided|95.0|-12.0|33.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 2 has been presented.||
1609578|NCT02564055|2957102|Other||Difference in percentages|-0.8|||||2-Sided|95.0|-24.0|22.7|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 1 has been presented.||
1609579|NCT02564055|2957102|Other||Difference in percentages|5.9|||||2-Sided|95.0|-17.1|28.4|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 1 has been presented.||
1609580|NCT02564055|2957102|Other||Difference in percentages|5.3|||||2-Sided|95.0|-18.3|28.4|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.||
1609581|NCT02564055|2957103|Other||Difference in percentages|24.2|||||2-Sided|95.0|-40.3|80.9|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at EW has been presented.||
1609582|NCT02564055|2957103|Other||Difference in percentages|28.6|||||2-Sided|95.0|-19.2|71.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at EW has been presented.||
1609583|NCT02564055|2957103|Other||Difference in percentages|-9.1|||||2-Sided|95.0|-62.4|47.8|||||Difference between GSK2894512 1 % QD and Vehicle QD at EW has been presented.||
1609584|NCT02564055|2957103|Other||Difference in percentages|33.3|||||2-Sided|95.0|-31.9|90.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at EW has been presented.||
1609585|NCT02564055|2957103|Other||Difference in percentages|-0.6|||||2-Sided|95.0|-26.0|25.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 16 has been presented.||
1609586|NCT02564055|2957103|Other||Difference in percentages|17.2|||||2-Sided|95.0|-9.0|41.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 16 has been presented.||
1609587|NCT02564055|2957103|Other||Difference in percentages|5.8|||||2-Sided|95.0|-19.7|30.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 16 has been presented.||
1609588|NCT02564055|2957103|Other||Difference in percentages|9.8|||||2-Sided|95.0|-15.5|33.9|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 16 has been presented.||
1609589|NCT02564055|2957103|Other||Difference in percentages|7.8|||||2-Sided|95.0|-17.8|33.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 14 has been presented.||
1609590|NCT02564055|2957103|Other||Difference in percentages|17.7|||||2-Sided|95.0|-8.4|41.9|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 14 has been presented.||
1609591|NCT02564055|2957103|Other||Difference in percentages|6.3|||||2-Sided|95.0|-19.5|31.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 14 has been presented.||
1609592|NCT02564055|2957103|Other||Difference in percentages|22.3|||||2-Sided|95.0|-3.1|45.3|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 14 has been presented.||
1609593|NCT02564055|2957103|Other||Difference in percentages|-9.7|||||2-Sided|95.0|-34.6|16.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 12 has been presented.||
1609594|NCT02564055|2957103|Other||Difference in percentages|32.6|||||2-Sided|95.0|6.9|55.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 12 has been presented.||
1609595|NCT02564055|2957103|Other||Difference in percentages|-0.2|||||2-Sided|95.0|-25.0|25.0|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 12 has been presented.||
1609596|NCT02564055|2957103|Other||Difference in percentages|19.0|||||2-Sided|95.0|-6.0|42.3|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 12 has been presented.||
1609597|NCT02564055|2957103|Other||Difference in percentages|23.4|||||2-Sided|95.0|-1.5|46.1|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 8 has been presented.||
1610442|NCT02553629|2957983|Superiority or Other|||||||0.001|||||||Mixed Models Analysis||||
1609598|NCT02564055|2957103|Other||Difference in percentages|26.7|||||2-Sided|95.0|1.7|49.0|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 8 has been presented.||
1609599|NCT02564055|2957103|Other||Difference in percentages|36.3|||||2-Sided|95.0|12.1|57.6|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 8 has been presented.||
1609600|NCT02564055|2957103|Other||Difference in percentages|21.9|||||2-Sided|95.0|-2.3|44.7|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 8 has been presented.||
1609601|NCT02564055|2957103|Other||Difference in percentages|18.3|||||2-Sided|95.0|-5.3|40.5|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 4 has been presented.||
1609602|NCT02564055|2957103|Other||Difference in percentages|26.5|||||2-Sided|95.0|2.3|48.4|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 4 has been presented.||
1609603|NCT02564055|2957103|Other||Difference in percentages|31.2|||||2-Sided|95.0|7.8|52.1|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 4 has been presented.||
1609604|NCT02564055|2957103|Other||Difference in percentages|39.6|||||2-Sided|95.0|16.0|60.0|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 4 has been presented.||
1609605|NCT02564055|2957103|Other||Difference in percentages|17.1|||||2-Sided|95.0|-6.4|39.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 2 has been presented.||
1609606|NCT02564055|2957103|Other||Difference in percentages|5.1|||||2-Sided|95.0|-18.0|27.8|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 2 has been presented.||
1609607|NCT02564055|2957103|Other||Difference in percentages|37.7|||||2-Sided|95.0|14.7|57.6|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 2 has been presented.||
1609608|NCT02564055|2957103|Other||Difference in percentages|23.1|||||2-Sided|95.0|-0.3|44.6|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 2 has been presented.||
1609609|NCT02564055|2957103|Other||Difference in percentages|9.1|||||2-Sided|95.0|-14.5|32.0|||||Difference between GSK2894512 0.5 % QD and Vehicle QD at Week 1 has been presented.||
1609610|NCT02564055|2957103|Other||Difference in percentages|2.3|||||2-Sided|95.0|-19.5|24.5|||||Difference between GSK2894512 0.5 % BID and Vehicle BID at Week 1 has been presented.||
1609611|NCT02564055|2957103|Other||Difference in percentages|26.5|||||2-Sided|95.0|3.3|47.5|||||Difference between GSK2894512 1 % QD and Vehicle QD at Week 1 has been presented.||
1609612|NCT02564055|2957103|Other||Difference in percentages|21.1|||||2-Sided|95.0|-2.7|43.1|||||Difference between GSK2894512 1 % BID and Vehicle BID at Week 1 has been presented.||
1609613|NCT02564055|2957111|Other||Difference in percentages|-4.0|||||2-Sided|95.0|-29.3|21.6|||||Difference between GSK2894512 0.5 percent QD and Vehicle QD has been presented.||
1609614|NCT02564055|2957111|Other||Difference in percentages|14.3|||||2-Sided|95.0|-11.2|38.7|||||Difference between GSK2894512 0.5 percent BID and Vehicle BID has been presented.||
1609615|NCT02564055|2957111|Other||Difference in percentages|7.4|||||2-Sided|95.0|-18.3|32.0|||||Difference between GSK2894512 1 percent QD and Vehicle QD has been presented.||
1609616|NCT02564055|2957111|Other||Difference in percentages|22.6|||||2-Sided|95.0|-2.4|45.5|||||Difference between GSK2894512 1 percent BID and Vehicle BID has been presented.||
1609617|NCT02564042|2957135|Other||Proportion difference|25.0|||||2-Sided|95.0|-35.7|80.6|||||Difference between GSK2894512 0.5% BID and Vehicle BID at EW has been presented||
1609618|NCT02564042|2957135|Other||Proportion difference|42.9|||||2-Sided|95.0|-6.3|81.6|||||Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented||
1609619|NCT02564042|2957135|Other||Proportion difference|10.0|||||2-Sided|95.0|-36.9|53.9|||||Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented||
1609620|NCT02564042|2957135|Other||Proportion difference|35.7|||||2-Sided|95.0|6.5|60.2|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented||
1609621|NCT02564042|2957135|Other||Proportion difference|29.4|||||2-Sided|95.0|-0.3|55.0|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented||
1609622|NCT02564042|2957135|Other||Proportion difference|53.8|||||2-Sided|95.0|25.8|75.5|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented||
1609623|NCT02564042|2957135|Other||Proportion difference|53.1|||||2-Sided|95.0|24.7|75.6|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented||
1609624|NCT02564042|2957135|Other||Proportion difference|37.0|||||2-Sided|95.0|7.8|61.6|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented||
1609625|NCT02564042|2957135|Other||Proportion difference|23.9|||||2-Sided|95.0|-6.1|51.0|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented||
1609626|NCT02564042|2957135|Other||Proportion difference|61.5|||||2-Sided|95.0|34.6|81.0|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented||
1609627|NCT02564042|2957135|Other||Proportion difference|51.3|||||2-Sided|95.0|22.0|74.0|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented||
1609628|NCT02564042|2957135|Other||Proportion difference|30.7|||||2-Sided|95.0|1.6|55.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented||
1609629|NCT02564042|2957135|Other||Proportion difference|35.6|||||2-Sided|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented||
1609630|NCT02564042|2957135|Other||Proportion difference|51.0|||||2-Sided|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented||
1609631|NCT02564042|2957135|Other||Proportion difference|54.7|||||2-Sided|95.0|25.9|76.6|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented.||
1609632|NCT02564042|2957135|Other||Proportion difference|40.6|||||2-Sided|95.0|12.8|63.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented.||
1609633|NCT02564042|2957135|Other||Proportion difference|33.3|||||2-Sided|95.0|4.8|58.2|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented .||
1609634|NCT02564042|2957135|Other||Proportion difference|37.0|||||2-Sided|95.0|8.7|61.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented||
1609635|NCT02564042|2957135|Other||Proportion difference|42.3|||||2-Sided|95.0|13.8|66.0|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented||
1609636|NCT02564042|2957135|Other||Proportion difference|12.5|||||2-Sided|95.0|-13.6|37.4|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented .||
1609637|NCT02564042|2957135|Other||Proportion difference|12.7|||||2-Sided|95.0|-15.1|38.9|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented||
1609638|NCT02564042|2957135|Other||Proportion difference|19.4|||||2-Sided|95.0|-6.9|43.6|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented .||
1609639|NCT02564042|2957135|Other||Proportion difference|9.7|||||2-Sided|95.0|-18.2|36.7|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented||
1609640|NCT02564042|2957135|Other||Proportion difference|6.3|||||2-Sided|95.0|-19.3|31.0|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented||
1609641|NCT02564042|2957135|Other||Proportion difference|10.0|||||2-Sided|95.0|-17.1|36.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented .||
1609642|NCT02564042|2957135|Other||Proportion difference|9.1|||||2-Sided|95.0|-15.4|33.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented .||
1609643|NCT02564042|2957135|Other||Proportion difference|9.4|||||2-Sided|95.0|-17.5|35.3|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented||
1609644|NCT02564042|2957135|Other||Proportion difference|-0.3|||||2-Sided|95.0|-25.4|25.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 1 has been presented||
1609645|NCT02564042|2957135|Other||Proportion difference|-3.6|||||2-Sided|95.0|-28.8|21.9|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 1 has been presented||
1609646|NCT02564042|2957144|Other||Proportion difference|42.9|||||2-Sided|95.0|-6.3|81.6|||||Difference between GSK2894512 1% QD and Vehicle QD at EW has been presented||
1609647|NCT02564042|2957144|Other||Proportion difference|10.0|||||2-Sided|95.0|-36.9|53.9|||||Difference between GSK2894512 1% BID and Vehicle BID at EW has been presented||
1609648|NCT02564042|2957144|Other||Proportion difference|48.3|||||2-Sided|95.0|19.7|71.1|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 16 has been presented||
1609649|NCT02564042|2957144|Other||Proportion difference|35.6|||||2-Sided|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 16 has been presented||
1609650|NCT02564042|2957144|Other||Proportion difference|52.4|||||2-Sided|95.0|24.4|74.0|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 16 has been presented||
1609651|NCT02564042|2957144|Other||Proportion difference|52.0|||||2-Sided|95.0|23.2|74.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 16 has been presented||
1609652|NCT02564042|2957144|Other||Proportion difference|42.9|||||2-Sided|95.0|14.4|66.5|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 14 has been presented||
1609653|NCT02564042|2957144|Other||Proportion difference|30.0|||||2-Sided|95.0|0.2|56.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 14 has been presented||
1609654|NCT02564042|2957144|Other||Proportion difference|60.1|||||2-Sided|95.0|33.2|80.1|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 14 has been presented||
1609655|NCT02564042|2957144|Other||Proportion difference|49.4|||||2-Sided|95.0|20.1|72.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 14 has been presented||
1609656|NCT02564042|2957144|Other||Proportion difference|41.4|||||2-Sided|95.0|12.7|65.0|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 12 has been presented||
1609657|NCT02564042|2957144|Other||Proportion difference|30.4|||||2-Sided|95.0|1.0|56.1|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 12 has been presented||
1609658|NCT02564042|2957144|Other||Proportion difference|51.0|||||2-Sided|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 12 has been presented||
1609659|NCT02564042|2957144|Other||Proportion difference|49.4|||||2-Sided|95.0|20.1|72.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 12 has been presented||
1609660|NCT02564042|2957144|Other||Proportion difference|34.4|||||2-Sided|95.0|6.3|58.7|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 8 has been presented||
1609661|NCT02564042|2957144|Other||Proportion difference|32.0|||||2-Sided|95.0|3.5|57.2|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 8 has been presented||
1609662|NCT02564042|2957144|Other||Proportion difference|37.0|||||2-Sided|95.0|8.7|61.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 8 has been presented||
1609663|NCT02564042|2957144|Other||Proportion difference|45.0|||||2-Sided|95.0|16.6|68.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 8 has been presented||
1609664|NCT02564042|2957144|Other||Proportion difference|6.3|||||2-Sided|95.0|-19.7|31.7|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 4 has been presented||
1609665|NCT02564042|2957144|Other||Proportion difference|9.2|||||2-Sided|95.0|-18.4|35.7|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 4 has been presented||
1609666|NCT02564042|2957144|Other||Proportion difference|25.8|||||2-Sided|95.0|-0.4|49.3|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 4 has been presented||
1609667|NCT02564042|2957144|Other||Proportion difference|27.6|||||2-Sided|95.0|-0.5|52.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 4 has been presented||
1609668|NCT02564042|2957144|Other||Proportion difference|3.1|||||2-Sided|95.0|-22.2|28.1|||||Difference between GSK2894512 0.5% QD and Vehicle QD at Week 2 has been presented||
1609669|NCT02564042|2957144|Other||Proportion difference|3.3|||||2-Sided|95.0|-23.6|29.9|||||Difference between GSK2894512 0.5% BID and Vehicle BID at Week 2 has been presented||
1609670|NCT02564042|2957144|Other||Proportion difference|15.2|||||2-Sided|95.0|-9.6|39.1|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 2 has been presented||
1609671|NCT02564042|2957144|Other||Proportion difference|6.3||||||95.0|-20.5|32.4|||||Difference between GSK2894512 1% BID and Vehicle BID at Week 2 has been presented||
1609672|NCT02564042|2957144|Other||Proportion difference|2.9|||||2-Sided|95.0|-21.0|26.6|||||Difference between GSK2894512 1% QD and Vehicle QD at Week 1 has been presented||
1609673|NCT02564042|2957145|Other||Proportion difference|30.7|||||2-Sided|95.0|1.6|55.9|||||Difference between GSK2894512 0.5% QD and Vehicle QD has been presented||
1610246|NCT02554786|2957883|Superiority||Hazard Ratio (HR)|0.14||||0.063|2-Sided|95.0|0.02|1.11|||Regression, Cox||||
1609674|NCT02564042|2957145|Other||Proportion difference|35.6|||||2-Sided|95.0|6.3|60.5|||||Difference between GSK2894512 0.5% BID and Vehicle BID has been presented||
1609675|NCT02564042|2957145|Other||Proportion difference|51.0|||||2-Sided|95.0|22.2|73.2|||||Difference between GSK2894512 1% QD and Vehicle QD has been presented||
1609676|NCT02564042|2957145|Other||Proportion difference|54.7|||||2-Sided|95.0|25.9|76.6|||||Difference between GSK2894512 1% BID and Vehicle BID has been presented||
1609677|NCT02564029|2957155|Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.65|||2-Sided|90.0|-1.11|1.13||||||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609678|NCT02564029|2957155|Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.66|||2-Sided|90.0|-1.18|1.1||||||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609679|NCT02564029|2957155|Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.66|||2-Sided|90.0|-1.08|1.19||||||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609680|NCT02564029|2957155|Other||Mean Difference (Final Values)|-4.38|Standard Error of the Mean|0.69|||2-Sided|90.0|-5.57|-3.19||||||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609681|NCT02564029|2957155|Other||Mean Difference (Final Values)|-4.37|Standard Error of the Mean|0.69|||2-Sided|90.0|-5.57|-3.17||||||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609682|NCT02564029|2957155|Other||Mean Difference (Final Values)|-4.42|Standard Error of the Mean|0.68|||2-Sided|90.0|-5.6|-3.25||||||In eyes open condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609683|NCT02564029|2957155|Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.72|||2-Sided|90.0|-2.09|0.7||||||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609684|NCT02564029|2957155|Other||Mean Difference (Final Values)|-0.77|Standard Error of the Mean|0.74|||2-Sided|90.0|-2.19|0.65||||||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609685|NCT02564029|2957155|Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.72|||2-Sided|90.0|-1.31|1.46||||||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609686|NCT02564029|2957155|Other||Mean Difference (Final Values)|-5.74|Standard Error of the Mean|0.76|||2-Sided|90.0|-7.2|-4.28||||||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609687|NCT02564029|2957155|Other||Mean Difference (Final Values)|-6.44|Standard Error of the Mean|0.78|||2-Sided|90.0|-7.93|-4.95||||||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609688|NCT02564029|2957155|Other||Mean Difference (Final Values)|-6.51|Standard Error of the Mean|0.79|||2-Sided|90.0|-8.01|-5.01||||||In eyes closed condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609689|NCT02564029|2957155|Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|1.36|||2-Sided|90.0|-2.56|2.16||||||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609690|NCT02564029|2957155|Other||Mean Difference (Final Values)|-1.01|Standard Error of the Mean|1.4|||2-Sided|90.0|-3.43|1.41||||||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609691|NCT02564029|2957155|Other||Mean Difference (Final Values)|0.81|Standard Error of the Mean|1.38|||2-Sided|90.0|-1.58|3.2||||||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609692|NCT02564029|2957155|Other||Mean Difference (Final Values)|-5.22|Standard Error of the Mean|1.37|||2-Sided|90.0|-7.6|-2.84||||||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609693|NCT02564029|2957155|Other||Mean Difference (Final Values)|-5.42|Standard Error of the Mean|1.36|||2-Sided|90.0|-7.78|-3.06||||||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609694|NCT02564029|2957155|Other||Mean Difference (Final Values)|-6.23|Standard Error of the Mean|1.37|||2-Sided|90.0|-8.6|-3.86||||||In eye closure condition. The same mixed model repeated measures analysis as applied to the primary outcome measure was used.|
1609695|NCT02564029|2957156|Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|1.36|||2-Sided|90.0|-2.56|2.16||||||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.|
1609696|NCT02564029|2957156|Other||Mean Difference (Final Values)|-1.01|Standard Error of the Mean|1.4|||2-Sided|90.0|-3.43|1.41||||||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.|
1609697|NCT02564029|2957156|Other||Mean Difference (Final Values)|0.81|Standard Error of the Mean|1.38|||2-Sided|90.0|-1.58|3.2||||||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.|
1609763|NCT02559895|2957482|Superiority||Mean Difference (Final Values)|-0.69|Standard Deviation|3.4||0.0182|2-Sided|95.0|-1.25|-0.12|||ANCOVA||||
1609698|NCT02564029|2957156|Other||Mean Difference (Final Values)|-5.22|Standard Error of the Mean|1.37|||2-Sided|90.0|-7.6|-2.84||||||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.|
1609699|NCT02564029|2957156|Other||Mean Difference (Final Values)|-5.42|Standard Error of the Mean|1.36|||2-Sided|90.0|-7.78|-3.06||||||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.|
1609700|NCT02564029|2957156|Other||Mean Difference (Final Values)|-6.23|Standard Error of the Mean|1.37|||2-Sided|90.0|-8.6|-3.86||||||A mixed effects model was applied with fixed effects for period, time, treatment, and the interaction between treatment and time. Baseline was included as 2 separate covariates. The interaction between each baseline covariate and time were included as fixed effects. Participant was fitted as a random effect and time was fitted as a repeated effect within each participant × period. An unstructured correlation matrix was used. The effect reported is an average across all post-dose measurements.|
1609701|NCT02563899|2957169|Superiority or Other||Percent difference in treatment|27.0|||||2-Sided|95.0|-8.5|62.6|||||||
1609702|NCT02563899|2957171|Superiority or Other||Percent difference in treatment|9.0|||||2-Sided|95.0|-25.2|44.0||||||Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vs Vehicle: <=-70%|
1609703|NCT02563899|2957171|Superiority or Other||Percent difference in treatment|1.0|||||2-Sided|95.0|-39.9|42.2||||||Umeclidinium, 2 mg/cm^2 of 1.85%, OD vs Vehicle: <=-50%|
1609704|NCT02563899|2957171|Superiority or Other||Percent difference in treatment|-1.0|||||2-Sided|95.0|-42.2|39.9||||||Umeclidinium, 2 mg/cm^2 of 1.85%, OD Vs Vehicle: <=-30%|
1609705|NCT02563106|2957218|Other|The analysis of the primary endpoint was based on the mITT analysis set. Per-protocol and worse case analyses were performed as sensitivity analyses.The P-value was based on a one-sided z-test for the comparison of the treatment difference between the SYN-004 group and the Placebo group.|Relative Risk Reduction (%)|71.4||||0.045|2-Sided|95.0|-35.9|94.0||Study was designed to provide 80% power to detect treatment effect with one-sided alpha = 0.05 on the primary endpoint. Based on the pre-specified z-test the one-sided P=0.045.|z-test|1-sided P=0.045.|Relative Risk Reduction in SYN-004 group compared to Placebo group.|The Modified Intent-to-Treat (mITT) analysis set included randomized subjects who received at least 1 dose of study drug. Number of subjects with CDI, imputing early termination without CDI as not being treatment failures.|
1609706|NCT02561806|2957271|Superiority||Risk Ratio (RR)|1.391||||0.012|2-Sided|95.0|1.085|1.698|||Regression, Logistic||||
1609707|NCT02561806|2957278|Superiority||Risk Ratio (RR)|3.421||||0.021|2-Sided|95.0|1.353|5.488|||Regression, Logistic||||
1609708|NCT02561806|2957279|Superiority||Risk Ratio (RR)|1.469|||<|0.001|2-Sided|95.0|1.244|1.695|||Regression, Logistic||||
1609709|NCT02561806|2957280|Superiority||Risk Ratio (RR)|2.699||||0.009|2-Sided|95.0|1.423|3.975|||Regression, Logistic||||
1609710|NCT02561806|2957281|Superiority||Risk Ratio (RR)|1.285|||<|0.001|2-Sided|95.0|1.13|1.439|||Regression, Logistic||||
1609711|NCT02561806|2957282|Non-Inferiority|Non-inferiority margin was -12.6% for 97.5% confidence interval|Risk Difference (RD)|0.321|||<|0.001|2-Sided|97.5|0.198|0.445|||Regression, Logistic||||
1609712|NCT02561585|2957298|Superiority||Mean Difference (Final Values)|-0.2||||0.97|2-Sided|95.0|-12.05|11.65||t-test in a baseline adjusted linear model|t-test, 2 sided|t-test, 2 sided on a 5% level|||
1609713|NCT02561078|2957387|Superiority||Mean Difference (Net)|0.8||||0.1|2-Sided|95.0|-0.2|1.8|||Mixed Models Analysis||||
1609714|NCT02561078|2957388|Superiority||Relative Rate|1.21||||0.025|2-Sided|95.0|1.02|1.42|||Negative binomial regression||||
1609715|NCT02561078|2957389|Superiority||Odds Ratio (OR)|1.05||||0.919|2-Sided|95.0|0.39|2.86|||Regression, Logistic||||
1609716|NCT02561078|2957390|Superiority||Mean Difference (Net)|-48.4|||<|0.001|2-Sided|95.0|-74.1|-22.8|||Mixed Models Analysis||||
1609717|NCT02561078|2957391|Superiority||Mean Difference (Net)|0.6||||0.905|2-Sided|95.0|-9.5|10.8|||Mixed Models Analysis|||Overnight (3:00 AM)|
1609718|NCT02561078|2957391|Superiority||Mean Difference (Net)|16.7||||0.004|2-Sided|95.0|5.3|28.2|||Mixed Models Analysis|||2 Hours Post Evening Meal|
1609719|NCT02561078|2957391|Superiority||Mean Difference (Net)|9.1||||0.113|2-Sided|95.0|-2.2|20.4|||Mixed Models Analysis|||Pre Evening Meal|
1609720|NCT02561078|2957391|Superiority||Mean Difference (Net)|8.3||||0.16|2-Sided|95.0|-3.3|19.8|||Mixed Models Analysis|||2 Hours Post Mid-Day Meal|
1609721|NCT02561078|2957391|Superiority||Mean Difference (Net)|-8.9||||0.138|2-Sided|95.0|-20.6|2.9|||Mixed Models Analysis|||Pre Mid-Day Meal|
1609722|NCT02561078|2957391|Superiority||Mean Difference (Net)|-17.2||||0.008|2-Sided|95.0|-29.9|-4.6|||Mixed Models Analysis|||2 Hours Post Morning Meal|
1609723|NCT02561078|2957391|Superiority||Mean Difference (Net)|-22.5|||<|0.001|2-Sided|95.0|-32.1|-12.8|||Mixed Models Analysis|||Pre Morning Meal|
1609724|NCT02561078|2957392|Superiority||Odds Ratio (OR)|1.94||||0.005|2-Sided|95.0|1.23|3.07|||Regression, Logistic||||
1609725|NCT02561078|2957393|Superiority||Odds Ratio (OR)|1.97||||0.015|2-Sided|95.0|1.14|3.39|||Regression, Logistic||||
1609726|NCT02561078|2957394|Superiority||Mean Difference (Net)|-35.6|||<|0.001|2-Sided|95.0|-49.4|-21.7|||Mixed Models Analysis||||
1609727|NCT02561078|2957395|Non-Inferiority|The test for the primary objective of noninferiority was performed at the 0.05 significance level using the LS Mean estimate of the difference in change in HbA1c between the 2 treatments at Week 26. Noninferiority was established if the upper limit of a 2-sided 95% confidence interval (CI) for the difference (U 500R CSII minus U 500R MDI) was below the noninferiority margin (NIM) of 0.4%.|Mean Difference (Net)|-0.42|||<|0.001|2-Sided|95.0|-0.62|-0.22|||Mixed Models Analysis||||
1609728|NCT02560922|2957396|Superiority||Mean Difference (Final Values)|-0.87|||<|0.001|2-Sided|95.0|-1.24|-0.51|||Mixed Models Analysis|||Test of between-group difference in self-reported change in symptoms (from baseline) at 9 months|
1609729|NCT02560922|2957396|Superiority||Mean Difference (Final Values)|-1.27|||<|0.001|2-Sided|95.0|-1.6|-0.95|||Mixed Models Analysis|||Test of between-group difference in self-reported change in symptoms (from baseline) at 3 months|
1609730|NCT02560922|2957397|Superiority||Mean Difference (Final Values)|0.67||||0.002|2-Sided|95.0|0.24|1.09|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months|
1609731|NCT02560922|2957397|Superiority||Mean Difference (Final Values)|1.01|||<|0.001|2-Sided|95.0|0.61|1.41|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months|
1609732|NCT02560922|2957398|Superiority||Mean Difference (Final Values)|-1.02||||0.087|2-Sided|95.0|-2.19|0.15|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months|
1609733|NCT02560922|2957398|Superiority||Mean Difference (Final Values)|-0.5||||0.356|2-Sided|95.0|-1.57|0.57|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months|
1609734|NCT02560922|2957399|Superiority||Mean Difference (Final Values)|11.67|||<|0.001|2-Sided|95.0|5.08|18.27|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months|
1609735|NCT02560922|2957399|Superiority||Mean Difference (Final Values)|15.31|||<|0.001|2-Sided|95.0|9.09|21.53|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months|
1609736|NCT02560922|2957400|Superiority||Mean Difference (Final Values)|1.71||||0.12|2-Sided|95.0|-0.45|3.86|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months|
1609737|NCT02560922|2957400|Superiority||Mean Difference (Final Values)|0.76||||0.433|2-Sided|95.0|-1.15|2.66|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months|
1609738|NCT02560922|2957401|Superiority||Mean Difference (Final Values)|0.73||||0.502|2-Sided|95.0|-1.42|2.88|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months|
1609739|NCT02560922|2957401|Superiority||Mean Difference (Final Values)|1.71||||0.111|2-Sided|95.0|-0.4|3.82|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months|
1609740|NCT02560922|2957402|Superiority||Mean Difference (Final Values)|-1.14||||0.128|2-Sided|95.0|-2.6|0.33|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months|
1609741|NCT02560922|2957402|Superiority||Mean Difference (Final Values)|-0.83||||0.222|2-Sided|95.0|-2.18|0.51|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months|
1609742|NCT02560922|2957403|Superiority||Mean Difference (Final Values)|-2.2||||0.128|2-Sided|95.0|-5.03|0.63|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months|
1609743|NCT02560922|2957403|Superiority||Mean Difference (Final Values)|-1.61||||0.209|2-Sided|95.0|-4.14|0.91|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months|
1609744|NCT02560922|2957404|Superiority||Mean Difference (Final Values)|-3.31||||0.084|2-Sided|95.0|-7.07|0.44|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months|
1609745|NCT02560922|2957404|Superiority||Mean Difference (Final Values)|-2.62||||0.129|2-Sided|95.0|-6.01|0.77|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months|
1609746|NCT02560922|2957405|Superiority||Mean Difference (Final Values)|-0.84||||0.068|2-Sided|95.0|-1.73|0.06|||Mixed Models Analysis|||Test of between group difference in change from baseline to 9 months|
1609747|NCT02560922|2957405|Superiority||Mean Difference (Final Values)|-0.63||||0.128|2-Sided|95.0|-1.45|0.18|||Mixed Models Analysis|||Test of between group difference in change from baseline to 3 months|
1609748|NCT02560584|2957417|Superiority||||||<|0.0001|||||||Exact one-sided test for single proporti|||"The proportion of patients with one or more CIS lesions detected with BL and none with WL was to be evaluated using an exact binomial test for single proportion with a significance level of 2.5% (one-sided).~Null hypothesis: One or more CIS lesions are detected with BLC with Cysview and none with WL in less than or equal to 0.1% of the patients."|
1609749|NCT02560584|2957419|Superiority||||||<|0.0001|||||||Exact one-sided test for a single propor|||"The proportion of patients with malignancy detected only with BLC with Cysview was to be analyzed using an exact one-sided test for a single proportion based on the cumulative binomial distribution with a significance level of 2.5%.~Null hypothesis: Malignancy is detected with BL only in 0.5% or less of the patients"|
1609750|NCT02559895|2957478|Superiority|||||||0.1539|||||||Cochran-Mantel-Haenszel||||
1609751|NCT02559895|2957478|Superiority|||||||0.0312|||||||Cochran-Mantel-Haenszel||||
1609752|NCT02559895|2957478|Superiority|||||||0.0159|||||||Cochran-Mantel-Haenszel||||
1609753|NCT02559895|2957479|Superiority||Mean Difference (Final Values)|12.8||||0.0064|2-Sided|95.0|3.7|22.0|||Cochran-Mantel-Haenszel||||
1609754|NCT02559895|2957479|Superiority||Mean Difference (Final Values)|12.4||||0.0085|2-Sided|95.0|3.2|21.5|||Cochran-Mantel-Haenszel||||
1609755|NCT02559895|2957479|Superiority||Mean Difference (Final Values)|18.9||||0.0001|2-Sided|95.0|9.8|28.0|||Cochran-Mantel-Haenszel||||
1609756|NCT02559895|2957480|Superiority||Mean Difference (Final Values)|9.8||||0.017|2-Sided|95.0|1.8|17.8|||Cochran-Mantel-Haenszel||||
1609757|NCT02559895|2957480|Superiority||Mean Difference (Final Values)|10.5||||0.0112|2-Sided|95.0|2.4|18.6|||Cochran-Mantel-Haenszel||||
1609758|NCT02559895|2957480|Superiority||Mean Difference (Final Values)|11.3||||0.0066|2-Sided|95.0|3.2|19.3|||Cochran-Mantel-Haenszel||||
1609759|NCT02559895|2957481|Superiority||Mean Difference (Final Values)|8.4||||0.0272|2-Sided|95.0|1.0|15.9|||Cochran-Mantel-Haenszel||||
1609760|NCT02559895|2957481|Superiority||Mean Difference (Final Values)|6.0||||0.1126|2-Sided|95.0|-1.4|13.3|||Cochran-Mantel-Haenszel||||
1609761|NCT02559895|2957481|Superiority||Mean Difference (Final Values)|13.5||||0.0007|2-Sided|95.0|5.8|21.2|||Cochran-Mantel-Haenszel||||
1609762|NCT02559895|2957482|Superiority||Mean Difference (Final Values)|-0.82|Standard Deviation|3.4||0.0046|2-Sided|95.0|-1.39|-0.25|||ANCOVA||||
1610443|NCT02553538|2957984|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1609764|NCT02559895|2957482|Superiority||Mean Difference (Final Values)|-1.11|Standard Deviation|3.4||0.0001|2-Sided|95.0|-1.68|-0.54|||ANCOVA||||
1609765|NCT02559622|2957513|Superiority||Least Square (LS) mean difference|1.17||||0.223|2-Sided|95.0|-0.72|3.06|||ANCOVA||||
1609766|NCT02559570|2957515|Superiority||Least Squares Mean Difference|0.08|Standard Error of the Mean|0.44||0.856|2-Sided|95.0|-0.789|0.949|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.||
1609767|NCT02559570|2957515|Superiority||Least Squares Mean Difference|-0.235|Standard Error of the Mean|0.435||0.5892|2-Sided|95.0|-1.095|0.624|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.||
1609768|NCT02559570|2957515|Superiority||Least Squares Mean Difference|-0.425|Standard Error of the Mean|0.45||0.3461|2-Sided|95.0|-1.313|0.463|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.||
1609769|NCT02559570|2957516|Superiority||Least Squares Mean Difference|0.039|Standard Error of the Mean|0.149||0.7933|2-Sided|95.0|-0.254|0.332|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.||
1609770|NCT02559570|2957516|Superiority||Least Squares Mean Difference|0.028|Standard Error of the Mean|0.146||0.8505|2-Sided|95.0|-0.262|0.317|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.||
1609771|NCT02559570|2957516|Superiority||Least Squares Mean Difference|0.048|Standard Error of the Mean|0.152||0.7507|2-Sided|95.0|-0.252|0.349|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.||
1609772|NCT02559570|2957517|Superiority||Least Squares Mean Difference|-0.199|Standard Error of the Mean|0.202||0.3263|2-Sided|95.0|-0.6|0.201|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average|
1609773|NCT02559570|2957517|Superiority||Least Squares Mean Difference|-0.113|Standard Error of the Mean|0.204||0.5802|2-Sided|95.0|-0.517|0.29|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average|
1609774|NCT02559570|2957517|Superiority||Least Squares Mean Difference|-0.054|Standard Error of the Mean|0.206||0.7923|2-Sided|95.0|-0.461|0.352|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average|
1609775|NCT02559570|2957517|Superiority||Least Squares Mean Difference|-0.236|Standard Error of the Mean|0.205||0.2529|2-Sided|95.0|-0.641|0.17|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation|
1609776|NCT02559570|2957517|Superiority||Least Squares Mean Difference|-0.121|Standard Error of the Mean|0.207||0.5602|2-Sided|95.0|-0.53|0.288|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation|
1609777|NCT02559570|2957517|Superiority||Least Squares Mean Difference|-0.053|Standard Error of the Mean|0.208||0.7997|2-Sided|95.0|-0.465|0.359|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation|
1609778|NCT02559570|2957518|Superiority||Least Squares Mean Difference|0.262|Standard Error of the Mean|0.235||0.2676|2-Sided|95.0|-0.204|0.728|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average|
1609779|NCT02559570|2957518|Superiority||Least Squares Mean Difference|-0.074|Standard Error of the Mean|0.235||0.7543|2-Sided|95.0|-0.54|0.392|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average|
1609780|NCT02559570|2957518|Superiority||Least Squares Mean Difference|-0.062|Standard Error of the Mean|0.239||0.7949|2-Sided|95.0|-0.535|0.41|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Weighted average|
1609781|NCT02559570|2957518|Superiority||Least Squares Mean Difference|0.356|Standard Error of the Mean|0.246||0.1502|2-Sided|95.0|-0.131|0.842|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation|
1609782|NCT02559570|2957518|Superiority||Least Squares Mean Difference|-0.038|Standard Error of the Mean|0.246||0.877|2-Sided|95.0|-0.525|0.448|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation|
1609783|NCT02559570|2957518|Superiority||Least Squares Mean Difference|-0.05|Standard Error of the Mean|0.249||0.8426|2-Sided|95.0|-0.543|0.444|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.|Adult derivation|
1609784|NCT02559570|2957519|Superiority||Least Squares Mean Difference|0.364|Standard Error of the Mean|0.563||0.5188|2-Sided|95.0|-0.748|1.477|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.||
1609785|NCT02559570|2957519|Superiority||Least Squares Mean Difference|-0.186|Standard Error of the Mean|0.557||0.7384|2-Sided|95.0|-1.286|0.913|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.||
1609786|NCT02559570|2957519|Superiority||Least Squares Mean Difference|-0.588|Standard Error of the Mean|0.577||0.3097|2-Sided|95.0|-1.729|0.552|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.||
1609787|NCT02559570|2957520|Superiority||Least Squares Mean Difference|0.12|Standard Error of the Mean|0.146||0.4107|2-Sided|95.0|-0.167|0.408|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.||
1609788|NCT02559570|2957520|Superiority||Least Squares Mean Difference|0.001|Standard Error of the Mean|0.143||0.993|2-Sided|95.0|-0.282|0.284|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.||
1609789|NCT02559570|2957520|Superiority||Least Squares Mean Difference|-0.042|Standard Error of the Mean|0.149||0.7789|2-Sided|95.0|-0.335|0.252|||ANCOVA|ANCOVA model estimates/t-tests comparing specified treatment groups, controlling for age group and baseline value.|ANCOVA model was applied with treatment arm groups (linaclotide doses A, B, and C, and placebo) and age group (6 to 11 years of age and 12 to 17 years of age) as factors and baseline value as covariate.||
1609790|NCT02559310|2957526|Non-Inferiority|Non-Inferiority Margin = 10%|Treatment Difference (Lef - Mox)|-2.5|||||2-Sided|95.0|-8.7|3.7|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed using continuity-corrected Z-statistic||
1609791|NCT02559310|2957526|Non-Inferiority|Non-Inferiority Margin = 10%.|Treatment Difference|-2.5|||||2-Sided|95.0|-8.4|3.4|||||Difference in percentage of success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use [Y vs. N] and PORT risk class [III vs. IV/V], using CMH stratum weights.||
1609792|NCT02559310|2957527|Non-Inferiority|Non-Inferiority Margin = 10%|Treatment Difference (Lef - Mox)|-2.6|||||2-Sided|95.0|-9.2|4.1|||||Difference in percentage of Success for IACR at test of cure visit. CI computed using continuity-corrected Z-statistic.||
1609793|NCT02559310|2957527|Non-Inferiority|Non-inferiority Margin = 10%.|Treatment Difference (Lef - Mox)|-2.6|||||2-Sided|95.0|-8.9|3.9|||||Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use [Y vs. N] and PORT risk class [III vs. IV/V], using CMH stratum weights.||
1609794|NCT02559310|2957528|Non-Inferiority|Non-inferiority Margin = 12.5%.|Treatment Difference (Lef - Mox)|-2.9|||||2-Sided|95.0|-8.5|2.8|||||Difference in percentage of Responders for ECR (Lefamulin - Moxifloxacin). CI computed using continuity-corrected Z-statistic.||
1609795|NCT02559206|2957529|Superiority|||||||0.8578||||||For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.|Correlation test||||
1609796|NCT02559206|2957529|Superiority||Odds Ratio (OR)|0.89||||0.8011|2-Sided|95.0|0.37|2.14|||Cochran-Mantel-Haenszel||||
1609797|NCT02559206|2957529|Superiority||Odds Ratio (OR)|1.11||||0.8021|2-Sided|95.0|0.48|2.58|||Cochran-Mantel-Haenszel||||
1609798|NCT02559206|2957529|Superiority||Odds Ratio (OR)|1.13||||0.771|2-Sided|95.0|0.49|2.58|||Cochran-Mantel-Haenszel||||
1609799|NCT02559206|2957529|Superiority||Odds Ratio (OR)|1.71||||0.1663|2-Sided|95.0|0.79|3.7|||Cochran-Mantel-Haenszel||||
1609800|NCT02559206|2957530|Superiority|||||||0.0249||||||For each DR formulation, the Correlation Test p-values are obtained from the correlation statistic controlling for geographic region.|Correlation test||||
1609801|NCT02559206|2957530|Superiority||Odds Ratio (OR)|2.39||||0.0262|2-Sided|95.0|1.1|5.19|||Cochran-Mantel-Haenszel||||
1609802|NCT02559206|2957530|Superiority||Odds Ratio (OR)|1.27||||0.554|2-Sided|95.0|0.57|2.85|||Cochran-Mantel-Haenszel||||
1609803|NCT02559206|2957530|Superiority||Odds Ratio (OR)|1.39||||0.4399|2-Sided|95.0|0.61|3.17|||Cochran-Mantel-Haenszel||||
1609805|NCT02559206|2957531|Superiority|||||||0.4201||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test||||
1609806|NCT02559206|2957531|Superiority||LS Mean Difference (Lin-Placebo)|-0.246||||0.5275|2-Sided|95.0|-1.011|0.519|||MMRM||||
1609807|NCT02559206|2957531|Superiority||LS Mean Difference (Lin-Placebo)|-0.095||||0.8069|2-Sided|95.0|-0.861|0.67|||MMRM||||
1609808|NCT02559206|2957531|Superiority||LS Mean Difference (Lin-Placebo)|0.161||||0.6801|2-Sided|95.0|-0.604|0.925|||MMRM||||
1609809|NCT02559206|2957531|Superiority||LS Mean Difference (Lin-Placebo)|0.992||||0.011|2-Sided|95.0|0.228|1.756|||MMRM||||
1609810|NCT02559206|2957532|Superiority|||||||0.07||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test||||
1609811|NCT02559206|2957532|Superiority||LS Mean Difference (Lin-Placebo)|0.662||||0.0904|2-Sided|95.0|-0.104|1.428|||MMRM||||
1609812|NCT02559206|2957532|Superiority||LS Mean Difference (Lin-Placebo)|0.299||||0.4447|2-Sided|95.0|-0.469|1.067|||MMRM||||
1609813|NCT02559206|2957532|Superiority||LS Mean Difference (Lin-Placebo)|0.048||||0.9013|2-Sided|95.0|-0.716|0.812|||MMRM||||
1609814|NCT02559206|2957532|Superiority||LS Mean Difference (Lin-Placebo)|0.992||||0.011|2-Sided|95.0|0.228|1.756|||MMRM||||
1609815|NCT02559206|2957533|Superiority|||||||0.5528||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test||||
1609816|NCT02559206|2957533|Superiority||LS Mean Difference (Lin-Placebo)|-0.258||||0.4333|2-Sided|95.0|-0.905|0.389|||MMRM||||
1609817|NCT02559206|2957533|Superiority||LS Mean Difference (Lin-Placebo)|-0.299||||0.3637|2-Sided|95.0|-0.947|0.348|||MMRM||||
1609818|NCT02559206|2957533|Superiority||LS Mean Difference (Lin-Placebo)|-0.455||||0.1669|2-Sided|95.0|-1.102|0.191|||MMRM||||
1609819|NCT02559206|2957533|Superiority||LS Mean Difference (Lin-Placebo)|-0.569||||0.0839|2-Sided|95.0|-1.214|0.076|||MMRM||||
1609820|NCT02559206|2957534|Superiority|||||||0.0276||||||Trend test performed using linear contrast statement for each DR formulation with placebo.|Trend Test||||
1609821|NCT02559206|2957534|Superiority||LS Mean Difference (Lin-Placebo)|-0.771||||0.0199|2-Sided|95.0|-1.419|-0.123|||MMRM||||
1609822|NCT02559206|2957534|Superiority||LS Mean Difference (Lin-Placebo)|-0.286||||0.3869|2-Sided|95.0|-0.936|0.363|||MMRM||||
1609823|NCT02559206|2957534|Superiority||LS Mean Difference (Lin-Placebo)|-0.297||||0.3661|2-Sided|95.0|-0.942|0.348|||MMRM||||
1609824|NCT02559206|2957534|Superiority||LS Mean Difference (Lin-Placebo)|-0.569||||0.0839|2-Sided|95.0|-1.214|0.076|||mixed model repeated measures (MMRM)||||
1609825|NCT02558829|2957546|Other|Negative percent agreement [%] = 100% x D/(B+D). D = test outcome negative for MAC core study part and negative for MAC repeatability extension; B = test outcome negative for MAC core study part and positive for MAC repeatability extension|CI (Clopper Pearson): negative agreement|100.0|||||2-Sided|95.0|79.41|100.0||||||Amendment no 1 had been issued for selected sites in Europe to obtain exploratory data on the repeatability of the MAC in a subset of subjects that had completed the core study.|
1609826|NCT02558829|2957546|Other|Positive percent agreement [%] = 100% x A/(A+C). A= test outcome positive for MAC core study part and positive for MAC repeatability extension; C = test outcome positive for MAC core study part and negative for MAC repeatability extension.|CI (Clopper Pearson): positive agreement|88.89|||||2-Sided|95.0|65.29|98.62||||||Please refer to Statistical Analysis 1 for this outcome.|
1609827|NCT02558829|2957547|Other|"Specificity is the probability that the test result is negative given the subject does not have the disease.~Specificity (SP) was estimated by: SP = TN/(TN+FP). TN = True AGHD negative Subjects; FP = False AGHD positive subjects."|CI (Clopper Pearson)|0.96|||||2-Sided|95.0|0.8|1.0||||||Specificity was estimated for the MAC at the pre-defined cut-off point GH: 2.8 ng/mL.|
1609828|NCT02558829|2957547|Other|Sensitivity is the probability that the test result is positive given the subject has the disease (for the purpose of this analysis, all group A subjects were assumed to have AGHD, but none of the group D subjects). Sensitivity (SS) was estimated by: SS = TP/(TP+FN). TP=True AGHD positive subject; FN=False AGHD negative subject.|CI (Clopper Pearson)|0.87|||||2-Sided|95.0|0.72|0.96||||||Sensitivity was estimated for the MAC at the pre-defined cut-off point GH: 2.8 ng/mL.|
1609829|NCT02558829|2957548|Other|Please refer to Statistical Analysis 1 for this secondary outcome measure.|Mean Difference (Final Values)|1.8|Standard Deviation|8.15|||2-Sided||||||||||
1609830|NCT02558829|2957548|Other||Mean Difference (Final Values)|-2.9|Standard Deviation|6.38|||2-Sided|||||||||"Pre/post dose comparison of ECGs was done for both GHSTs. During the GHSTs, ECGs were measured at pre-dose (up to 15 min before) and 60 minutes post-dose. Furthermore, ECGs were measured at screening and at End-of-Study (EOS) Visit.~Calculations were done from two time points: baseline and 60 min post-dose. Baseline is either the screening or pre-dose value."|
1609831|NCT02558829|2957550|Other|The secondary diagnostic accuracy measure was ‘percent overall agreement’.|overall agreement|83.57|||||2-Sided|95.0|76.38|89.29||||||This variable was analyzed using the same methodology described for the analyses for the primary efficacy variables. in the below, the results for Step 1 (peak GH level among all post baseline samples) are presented.|
1609832|NCT02558829|2957551|Other|Negative percent agreement [%] = 100% x D/(B+D). D = MAC outcome negative and ITT outcome negative; B = MAC outcome positive and ITT outcome negative|CI (Clopper Pearson): negative agreement|93.94|||||2-Sided|95.0|85.2|98.32||||||Please refer to Statistical Analysis 1.|
1609833|NCT02558829|2957551|Other|Positive percent agreement [%] = 100% x A/(A+C). A= MAC outcome positive and ITT outcome positive; C = MAC outcome negative and ITT positive|CI (Clopper Pearson): positive agreement|74.32|||||2-Sided|95.0|62.84|83.78||||||The estimated percentages of the agreements and the two-sided 95% confidence interval (or one-sided 97.5% confidence interval) of the percent agreement based on Clopper-Pearson are presented. The performance of the MAC (cut-off point 2.8 ng/mL) was considered to be acceptable if the lower bound of the two-sided 95% CI (or lower bound of the one-sided 97.5% CI) was 75% or higher for ‘percent negative agreement’, and 70% or higher for the ‘percent positive agreement’.|
1609834|NCT02558400|2957554|Superiority||||||<|0.0001|||||||t-test, 2 sided|PG324 vs. latanoprost|||
1609835|NCT02558400|2957554|Superiority|To claim superiority PG324 had to be statistically superior to netarsudil and to latanoprost at all 9 of 9 primary efficacy timepoints|||||<|0.0001|||||||t-test, 2 sided|PG324 vs. netarsudil|||
1609836|NCT02557698|2957557|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.687|2-Sided|95.0|-0.2|0.4|||t-test, 2 sided||||
1609837|NCT02557698|2957558|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.326|2-Sided|95.0|-0.4|0.1|||t-test, 2 sided||||
1609838|NCT02557698|2957559|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.662|2-Sided|95.0|-6.5|4.2|||t-test, 2 sided||||
1609839|NCT02557698|2957560|Superiority or Other||Mean Difference (Final Values)|-3.6||||0.143|2-Sided|95.0|-8.5|1.3|||t-test, 2 sided||||
1609840|NCT02557698|2957561|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.365|2-Sided|95.0|-2.6|0.9|||t-test, 2 sided||||
1609841|NCT02557698|2957562|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.325|2-Sided|95.0|-1.8|0.6|||t-test, 2 sided||||
1609842|NCT02557698|2957563|Superiority or Other||Mean Difference (Final Values)|4.1||||0.029|2-Sided|95.0|0.4|7.7|||t-test, 2 sided||||
1609843|NCT02557698|2957564|Superiority or Other||Mean Difference (Final Values)|3.6||||0.07|2-Sided|95.0|-0.3|7.4|||t-test, 2 sided||||
1609844|NCT02557698|2957565|Superiority or Other|||||||0.084|||||||Wilcoxon (Mann-Whitney)||||
1609845|NCT02557698|2957566|Superiority or Other|||||||0.831|||||||Wilcoxon (Mann-Whitney)||||
1609846|NCT02557698|2957567|Superiority or Other|||||||0.759|||||||Wilcoxon (Mann-Whitney)||||
1609847|NCT02557698|2957568|Superiority or Other|||||||0.182|||||||Wilcoxon (Mann-Whitney)||||
1609848|NCT02557698|2957569|Superiority or Other|||||||0.581|||||||Wilcoxon (Mann-Whitney)||||
1609849|NCT02557698|2957570|Superiority or Other|||||||0.259|||||||Wilcoxon (Mann-Whitney)||||
1609850|NCT02557698|2957571|Superiority or Other|||||||0.585|||||||Wilcoxon (Mann-Whitney)||||
1609851|NCT02557698|2957572|Superiority or Other|||||||0.822|||||||Wilcoxon (Mann-Whitney)||||
1609852|NCT02557698|2957573|Superiority or Other|||||||0.914|||||||Wilcoxon (Mann-Whitney)||||
1609853|NCT02557698|2957574|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1609854|NCT02557698|2957575|Superiority or Other||Mean Difference (Final Values)|0.1||||0.1|2-Sided|95.0|-0.1|0.4|||t-test, 2 sided||||
1609855|NCT02557698|2957576|Superiority or Other||Mean Difference (Final Values)|0.2||||0.4|2-Sided|95.0|-0.2|0.5|||t-test, 2 sided||||
1609856|NCT02557698|2957577|Superiority or Other||Mean Difference (Final Values)|-7.5||||0.059|2-Sided|95.0|-15.3|0.3|||t-test, 2 sided||||
1609857|NCT02557698|2957578|Superiority or Other||Mean Difference (Final Values)|-5.6||||0.171|2-Sided|95.0|-13.7|2.5|||t-test, 2 sided||||
1609858|NCT02557698|2957579|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.066|2-Sided|95.0|-3.5|0.1|||t-test, 2 sided||||
1609859|NCT02557698|2957580|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.458|2-Sided|95.0|-2.5|1.1|||t-test, 2 sided||||
1609860|NCT02557698|2957581|Superiority or Other||Mean Difference (Final Values)|4.4||||0.025|2-Sided|95.0|0.5|8.2|||t-test, 2 sided||||
1609861|NCT02557698|2957582|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.964|2-Sided|95.0|-3.9|3.7|||t-test, 2 sided||||
1609862|NCT02557698|2957583|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.017|2-Sided|95.0|-3.1|-0.3|||t-test, 2 sided||||
1609863|NCT02557698|2957584|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.024|2-Sided|95.0|-3.2|-0.2|||t-test, 2 sided||||
1609864|NCT02557698|2957585|Superiority or Other||Mean Difference (Final Values)|-2.3|||<|0.001|2-Sided|95.0|-3.5|-1.2|||t-test, 2 sided||||
1609865|NCT02557698|2957586|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.002|2-Sided|95.0|-3.1|-0.8|||t-test, 2 sided|||H0=Intervention and control groups do not differ with respect to the TEWL forearm at visit 3 H1=The TEWL on the forearm at visit 3 differs between the groups|
1609866|NCT02557646|2957588|Superiority or Other|||||||0.0062|||||||Chi-squared|||The relationship between the body weight-normalized dose of ribavirin and relapse rate was analyzed using Chi-square test.|
1609867|NCT02557646|2957589|Superiority or Other|||||||0.5885|||||||Chi-squared|||The relationship between the starting dose of ribavirin and relapse rate was analyzed using Chi-square test.|
1609868|NCT02557646|2957590|Superiority or Other|||||||0.1499|||||||Chi-squared|||The relationship between the cumulative dose of ribavirin and relapse rate was analyzed using Chi-square test.|
1609869|NCT02557646|2957596|Superiority or Other|||||||0.0475|||||||Chi-squared|||The relationship between the body weight-normalized dose of ribavirin and sustained virological (SVR) response was analyzed using Chi-square test.|
1609870|NCT02557646|2957597|Superiority or Other|||||||0.0263|||||||Chi-squared, Corrected|||The relationship between the body weight-normalized dose of ribavirin and virological response was analyzed using Chi-square test.|
1609871|NCT02557646|2957598|Superiority or Other|||||||0.374|||||||Chi-squared|||The relationship between the starting dose ribavirin and sustained virological response (SVR) was analyzed using Chi-square test.|
1609872|NCT02557646|2957599|Superiority or Other|||||||0.6859|||||||Chi-squared|||The relationship between the starting dose ribavirin and virological response was analyzed using Chi-square test.|
1609873|NCT02557646|2957601|Superiority or Other|||||||0.0437|||||||Chi-squared|||Cumulative dose of ribavirin >90%: the relationship between cumulative dose and SVR response in participants in whom the cumulative dose of ribavirin exceeded 90% was analyzed using Chi-square test.|
1609874|NCT02557555|2957602|Other||||||<|0.0001||||||Written information should always be available|Test of equal proportion (50/50)||||
1609875|NCT02557555|2957602|Other||||||<|0.0002||||||Information corrected any misconception|Test of equal proportion (50/50)||||
1609876|NCT02557555|2957602|Other||||||<|0.0001||||||Pamphlet information helped to reduce anxiety|Test of equal proportion (50/50)||||
1609877|NCT02557555|2957602|Other||||||<|0.0001||||||Pamphlet should be given before onset labor pain|Test of equal proportion (50/50)||||
1609878|NCT02557555|2957602|Other|P-values corresponding to a test of equal proportions (yes/no- 50%/50%)|||||<|0.0001||||||Pamphlet better explained options for pain|Test of equal proportion (50/50)||||
1609879|NCT02557555|2957602|Other|P-values corresponding to a test of equal proportions (yes/no- 50%/50%)|||||<|0.0001||||||Researched options for labor pain|Test of equal proportion (50/50)||||
1609982|NCT02556801|2957663|Superiority||Treatment effect|-0.394|Standard Error of the Mean|0.186|=|0|2-Sided|90.0|-0.702|-0.086|||ANOVA||||
1609880|NCT02557399|2957612|Superiority or Other||Mean Difference (Net)|-0.17||||0.08|2-Sided|95.0|-0.36|0.02|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609881|NCT02557399|2957612|Superiority or Other||Mean Difference (Net)|-0.22||||0.024|2-Sided|95.0|-0.41|-0.03|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609882|NCT02557399|2957612|Superiority or Other||Mean Difference (Net)|-0.22||||0.017|2-Sided|95.0|-0.4|-0.04|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609883|NCT02557399|2957612|Superiority or Other||Mean Difference (Net)|-0.22||||0.017|2-Sided|95.0|-0.4|-0.04|||mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609884|NCT02557399|2957616|Superiority or Other||Odds Ratio (OR)|2.3||||0.666|2-Sided|95.0|-5.8|10.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609885|NCT02557399|2957616|Superiority or Other||Difference in percentage|-0.8||||0.766|2-Sided|95.0|-10.1|8.5||The P-values are based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609886|NCT02557399|2957616|Superiority or Other||Difference in percentage|3.9||||0.519|2-Sided|95.0|-6.5|14.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609887|NCT02557399|2957616|Superiority or Other||Difference in percentage|3.3||||0.584|2-Sided|95.0|-6.7|13.4||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609888|NCT02557399|2957616|Superiority or Other||Difference in percentage|-2.0||||0.527|2-Sided|95.0|-9.4|5.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609889|NCT02557399|2957616|Superiority or Other||Difference in percentage|2.6||||0.424|2-Sided|95.0|-3.5|8.7||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609890|NCT02557399|2957616|Superiority or Other||Difference in percentage|3.6||||0.345|2-Sided|95.0|-3.8|11.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609891|NCT02557399|2957616|Superiority or Other||Difference in percentage|8.6||||0.044|2-Sided|95.0|0.4|16.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609892|NCT02557399|2957616|Superiority or Other||Difference in percentage|11.2||||0.016|2-Sided|95.0|1.8|20.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609893|NCT02557399|2957616|Superiority or Other||Difference in percentage|9.1||||0.048|2-Sided|95.0|-1.3|19.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609894|NCT02557399|2957616|Superiority or Other||Difference in percentage|1.9||||0.648|2-Sided|95.0|-5.2|9.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609895|NCT02557399|2957616|Superiority or Other||Difference in percentage|-0.5||||0.81|2-Sided|95.0|-8.8|7.7||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609896|NCT02557399|2957616|Superiority or Other||Difference in percentage|7.0||||0.18|2-Sided|95.0|-3.1|17.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609949|NCT02556801|2957660|Superiority||Treatment effect|1.99|||<|0.001|2-Sided|90.0|1.61|2.46|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)|
1609897|NCT02557399|2957616|Superiority or Other||Difference in percentage|4.7||||0.409|2-Sided|95.0|-5.7|15.1||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609898|NCT02557399|2957616|Superiority or Other||Difference in percentage|3.9||||0.379|2-Sided|95.0|-4.5|12.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609899|NCT02557399|2957617|Superiority or Other||Difference in percentage|11.3||||0.018|2-Sided|95.0|1.4|21.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609900|NCT02557399|2957617|Superiority or Other||Difference in percentage|7.9||||0.034|2-Sided|95.0|0.3|15.5||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609901|NCT02557399|2957617|Superiority or Other||Difference in percentage|7.1||||0.016|2-Sided|95.0|1.1|13.2||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609902|NCT02557399|2957617|Superiority or Other||Difference in percentage|1.3||||0.612|2-Sided|95.0|-3.4|5.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609903|NCT02557399|2957617|Superiority or Other||Difference in percentage|1.8||||0.129|2-Sided|95.0|-0.7|4.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609904|NCT02557399|2957618|Superiority or Other||Difference in percentage|10.7||||0.022|2-Sided|95.0|0.9|20.4||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609905|NCT02557399|2957618|Superiority or Other||Difference in percentage|10.2||||0.006|2-Sided|95.0|2.4|18.0||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609906|NCT02557399|2957618|Superiority or Other||Difference in percentage|3.7||||0.251|2-Sided|95.0|-2.5|9.9||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609907|NCT02557399|2957618|Superiority or Other||Difference in percentage|3.0||||0.185|2-Sided|95.0|-1.3|7.3||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609908|NCT02557399|2957618|Superiority or Other||Difference in percentage|2.3||||0.047|2-Sided|95.0|0.1|4.6||The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.|Cochran-Mantel-Haenszel||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1.The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.||
1609909|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|-0.6||||0.684|2-Sided|95.0|-3.5|2.3||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609910|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|1.2||||0.494|2-Sided|95.0|-2.3|4.7||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609911|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|-2.0||||0.314|2-Sided|95.0|-5.9|1.9||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609912|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|-3.1||||0.148|2-Sided|95.0|-7.4|1.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609913|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|1.8||||0.367|2-Sided|95.0|-2.1|5.7||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609914|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|-1.1||||0.078|2-Sided|95.0|-2.4|0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609915|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|-1.9||||0.012|2-Sided|95.0|-3.4|-0.4||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609916|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|-2.6||||0.002|2-Sided|95.0|-4.3|-1.0||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609917|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|-3.0||||0.002|2-Sided|95.0|-4.8|-1.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609918|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|-1.8||||0.068|2-Sided|95.0|-3.8|0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609919|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|-1.7||||0.338|2-Sided|95.0|-5.3|1.8||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609920|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|-0.7||||0.747|2-Sided|95.0|-4.9|3.5||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609921|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|-4.7||||0.044|2-Sided|95.0|-9.2|-0.1||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609922|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|-6.2||||0.015|2-Sided|95.0|-11.2|-1.2||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609923|NCT02557399|2957619|Superiority or Other||Mean Difference (Net)|-0.1||||0.961|2-Sided|95.0|-4.6|4.4||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609924|NCT02557399|2957620|Superiority or Other||difference in percent|-3.78||||0.073|2-Sided|95.0|-7.92|0.35||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609925|NCT02557399|2957620|Superiority or Other||difference in percent|-0.59||||0.818|2-Sided|95.0|-5.61|4.44||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609926|NCT02557399|2957620|Superiority or Other||difference in percent|-3.89||||0.186|2-Sided|95.0|-9.67|1.88||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609927|NCT02557399|2957620|Superiority or Other||difference in percent|-5.69||||0.085|2-Sided|95.0|-12.17|0.78||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609928|NCT02557399|2957620|Superiority or Other||difference in percent|2.71||||0.382|2-Sided|95.0|-3.38|8.8||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609929|NCT02557399|2957620|Superiority or Other||Mean Difference (Net)|-4.5||||0.015|2-Sided|95.0|-8.1|-0.89||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs||
1609930|NCT02557399|2957620|Superiority or Other||difference in percent|-6.69||||0.004|2-Sided|95.0|-11.21|-2.16||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609931|NCT02557399|2957620|Superiority or Other||difference in percent|-9.37|||<|0.001|2-Sided|95.0|-14.42|-4.33||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609932|NCT02557399|2957620|Superiority or Other||difference in percent|-8.43|||<|0.005|2-Sided|95.0|-14.35|-2.51||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609933|NCT02557399|2957620|Superiority or Other||difference in percent|-5.08|||<|0.115|2-Sided|95.0|-11.41|1.25||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609934|NCT02557399|2957621|Superiority or Other||difference in percent|-3.24||||0.062|2-Sided|95.0|-6.64|0.16||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12||
1609935|NCT02557399|2957621|Superiority or Other||difference in percent|-2.35||||0.257|2-Sided|95.0|-6.42|1.72||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8||
1609936|NCT02557399|2957621|Superiority or Other||difference in percent|-5.85||||0.01|2-Sided|95.0|-10.29|-1.42||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4||
1609937|NCT02557399|2957621|Superiority or Other||difference in percent|-0.25||||0.916|2-Sided|95.0|-4.85|4.35||The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1||
1609938|NCT02557399|2957622|Superiority or Other||difference in percent|-6.83||||0.008|2-Sided|95.0|-11.88|-1.78||The analysis method was mixed model repeated measures analysis with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.|mixed model repeated measures analysis||Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.||
1609939|NCT02556801|2957660|Superiority||Treatment effect|2.88|||<|0.001|2-Sided|90.0|1.8|4.62|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)|
1609940|NCT02556801|2957660|Superiority||Treatment effect|2.68|||<|0.001|2-Sided|90.0|1.67|4.3|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)|
1609941|NCT02556801|2957660|Superiority||Treatment effect|1.67|||<|0.04|2-Sided|90.0|1.03|2.69|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 10 months (Visit 6)|
1609942|NCT02556801|2957660|Superiority||Treatment effect|2.83|||<|0.001|2-Sided|90.0|1.88|4.24|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)|
1609943|NCT02556801|2957660|Superiority||Treatment effect|2.35|||<|0.001|2-Sided|90.0|1.56|3.53|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)|
1609944|NCT02556801|2957660|Superiority||Treatment effect|1.52|||<|0.048|2-Sided|90.0|1.01|2.31|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP5 levels after 5 months (Visit 4)|
1609945|NCT02556801|2957660|Superiority||Treatment effect|1.7|||<|0.001|2-Sided|90.0|1.31|2.19|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)|
1609946|NCT02556801|2957660|Superiority||Treatment effect|2.38|||<|0.001|2-Sided|90.0|1.84|3.08|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)|
1609947|NCT02556801|2957660|Superiority||Treatment effect|1.39|||<|0.019|2-Sided|90.0|1.07|1.81|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 10 months (Visit 6)|
1609948|NCT02556801|2957660|Superiority||Treatment effect|1.57|||<|0.001|2-Sided|90.0|1.27|1.94|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)|
1610444|NCT02553538|2957985|Superiority or Other||||||<|0.001|||||||Regression, Logistic||||
1609950|NCT02556801|2957660|Superiority||Treatment effect|1.18|||<|0.102|2-Sided|90.0|0.95|1.47|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 AP1 levels after 5 months (Visit 4)|
1609951|NCT02556801|2957660|Superiority||Treatment effect|2.12|||<|0.001|2-Sided|90.0|1.54|2.93|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)|
1609952|NCT02556801|2957660|Superiority||Treatment effect|2.88|||<|0.001|2-Sided|90.0|2.09|3.98|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)|
1609953|NCT02556801|2957660|Superiority||Treatment effect|1.48|||<|0.024|2-Sided|90.0|1.07|2.06|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 10 months (Visit 6)|
1609954|NCT02556801|2957660|Superiority||Treatment effect|2.03|||<|0.001|2-Sided|90.0|1.59|2.59|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)|
1609955|NCT02556801|2957660|Superiority||Treatment effect|2.15|||<|0.001|2-Sided|90.0|1.68|2.74|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)|
1609956|NCT02556801|2957660|Superiority||Treatment effect|1.33|||<|0.032|2-Sided|90.0|1.03|1.7|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG4 ATG levels after 5 months (Visit 4)|
1609957|NCT02556801|2957661|Superiority||Treatment effect|1.26||||0.002|2-Sided|90.0|1.11|1.43|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)|
1609958|NCT02556801|2957661|Superiority||Treatment effect|1.28|||<|0.001|2-Sided|90.0|1.13|1.45|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)|
1609959|NCT02556801|2957661|Superiority||Treatment effect|1.09|||<|0.126|2-Sided|90.0|0.96|1.24|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 10 months (Visit 6)|
1609960|NCT02556801|2957661|Superiority||Treatment effect|1.15|||<|0.004|2-Sided|90.0|1.06|1.25|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)|
1609961|NCT02556801|2957661|Superiority||Treatment effect|1.16|||<|0.002|2-Sided|90.0|1.07|1.27|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)|
1609962|NCT02556801|2957661|Superiority||Treatment effect|1.04|||<|0.212|2-Sided|90.0|0.96|1.14|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP5 levels after 5 months (Visit 4)|
1609963|NCT02556801|2957661|Superiority||Treatment effect|1.11|||<|0.008|2-Sided|90.0|1.03|1.2|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)|
1609964|NCT02556801|2957661|Superiority||Treatment effect|1.22|||<|0.001|2-Sided|90.0|1.13|1.31|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)|
1609965|NCT02556801|2957661|Superiority||Treatment effect|1.02|||<|0.312|2-Sided|90.0|0.95|1.1|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 10 months (Visit 6)|
1609966|NCT02556801|2957661|Superiority||Treatment effect|1.02|||<|0.269|2-Sided|90.0|0.97|1.08|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)|
1609967|NCT02556801|2957661|Superiority||Treatment effect|1.1|||<|0.003|2-Sided|90.0|1.04|1.16|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)|
1609968|NCT02556801|2957661|Superiority||Treatment effect|0.99|||<|0.341|2-Sided|90.0|0.93|1.04|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG AP1 levels after 5 months (Visit 4)|
1609969|NCT02556801|2957661|Superiority||Treatment effect|1.39|||<|0.001|2-Sided|90.0|1.19|1.62|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)|
1609970|NCT02556801|2957661|Superiority||Treatment effect|1.6|||<|0.001|2-Sided|90.0|1.37|1.87|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)|
1609971|NCT02556801|2957661|Superiority||Treatment effect|1.23|||<|0.015|2-Sided|90.0|1.05|1.45|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 10 months (Visit 6)|
1609972|NCT02556801|2957661|Superiority||Treatment effect|1.24|||<|0.001|2-Sided|90.0|1.12|1.37|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)|
1609973|NCT02556801|2957661|Superiority||Treatment effect|1.29|||<|0.001|2-Sided|90.0|1.17|1.43|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)|
1609974|NCT02556801|2957661|Superiority||Treatment effect|1.11|||<|0.057|2-Sided|90.0|1.0|1.23|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgG ATG levels after 5 months (Visit 4)|
1609975|NCT02556801|2957662|Superiority||Treatment effect|1.37||||0.042|2-Sided|90.0|1.01|1.85|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)|
1609976|NCT02556801|2957662|Superiority||Treatment effect|1.67||||0.003|2-Sided|90.0|1.24|2.25|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)|
1609977|NCT02556801|2957662|Superiority||Treatment effect|1.42||||0.029|2-Sided|90.0|1.05|1.93|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 10 months (Visit 6)|
1609978|NCT02556801|2957662|Superiority||Treatment effect|2.34|||<|0.001|2-Sided|90.0|1.73|3.15|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)|
1609979|NCT02556801|2957662|Superiority||Treatment effect|2.43|||<|0.001|2-Sided|90.0|1.8|3.27|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)|
1609980|NCT02556801|2957662|Superiority||Treatment effect|1.92|||<|0.001|2-Sided|90.0|1.41|2.6|||Mixed Models Analysis|||Analysis of change from baseline of serum specific IgE levels after 5 months (Visit 4)|
1609981|NCT02556801|2957663|Superiority||Treatment effect|-0.28|Standard Error of the Mean|0.182|=|0|2-Sided|90.0|-0.581|0.021|||ANOVA||||
1609983|NCT02556801|2957663|Superiority||Treatment effect|-0.354|Standard Error of the Mean|0.183|=|0|2-Sided|90.0|-0.657|-0.05|||ANOVA||||
1609984|NCT02556801|2957664|Superiority||Treatment effect|-0.5|Standard Error of the Mean|0.57|=|0|2-Sided|90.0|-1.45|0.46|||Mixed Models Analysis||||
1609985|NCT02556801|2957664|Superiority||Treatment effect|-0.62|Standard Error of the Mean|0.56|=|0|2-Sided|90.0|-1.55|0.32|||Mixed Models Analysis||||
1609986|NCT02556801|2957664|Superiority||Treatment effect|-0.07|Standard Error of the Mean|0.58|=|0|2-Sided|90.0|-1.03|0.88|||Mixed Models Analysis||||
1609987|NCT02556801|2957665|Superiority||Treatment effect|-1.11|Standard Error of the Mean|0.62|=|0|2-Sided|0.62|-2.13|-0.08|||Mixed Models Analysis||||
1609988|NCT02556801|2957665|Superiority||Treatment effect|-0.88|Standard Error of the Mean|0.61|=|0|2-Sided|90.0|-1.89|0.13|||Mixed Models Analysis||||
1609989|NCT02556801|2957665|Superiority||Treatment effect|-0.89|Standard Error of the Mean|0.63|=|0|2-Sided|90.0|-1.93|0.15|||Mixed Models Analysis||||
1609990|NCT02556801|2957666|Superiority||Treatment effect|-1.78|Standard Error of the Mean|1.08||0.05|2-Sided|90.0|-3.56|0.0|||Mixed Models Analysis||||
1609991|NCT02556801|2957666|Superiority||Treatment effect|-1.84|Standard Error of the Mean|1.06|=|0|2-Sided|90.0|-3.6|-0.09|||Mixed Models Analysis||||
1609992|NCT02556801|2957666|Superiority||Treatment effect|-0.6|Standard Error of the Mean|1.08|=|0.291|2-Sided|90.0|-2.39|1.19|||Mixed Models Analysis||||
1609993|NCT02556801|2957667|Superiority||Treatment effect|-2.3|Standard Error of the Mean|1.15||0.024|2-Sided|90.0|-4.2|-0.4|||Mixed Models Analysis||||
1609994|NCT02556801|2957667|Superiority||Treatment effect|-1.79|Standard Error of the Mean|1.14||0.059|2-Sided|90.0|-3.68|0.1|||Mixed Models Analysis||||
1609995|NCT02556801|2957667|Superiority||Treatment effect|-1.92|Standard Error of the Mean|1.17|=|0|2-Sided|90.0|-3.85|0.01|||Mixed Models Analysis||||
1609996|NCT02556801|2957668|Superiority||Treatment effect|-2.33|Standard Error of the Mean|1.15|||2-Sided|90.0|-4.23|-0.43|||||||
1609997|NCT02556801|2957668|Superiority||Treatment effect|-1.83|Standard Error of the Mean|1.14|||2-Sided|90.0|-3.72|0.06|||||||
1609998|NCT02556801|2957668|Superiority||Treatment effect|-1.96|Standard Deviation|1.17|||2-Sided|90.0|-3.89|-0.03|||||||
1609999|NCT02556801|2957668|Superiority||Test statistic|1.823||||0.057|1-Sided||||||MCP-Mod Method|The primary dose-response analysis was performed by applying linear, Emax, logistic and exponential models.The p-value was based on Emax model.|||
1610000|NCT02556632|2957670|Other|||||||0.8591|||||||ANOVA||||
1610001|NCT02556632|2957671|Other|||||||0.8048|||||||Fisher Exact||||
1610002|NCT02556632|2957672|Other|||||||0.9306|||||||ANOVA||||
1610003|NCT02556203|2957691|Other|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.84|||=|0|2-Sided|95.0|1.41|2.41|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs >1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.||
1610004|NCT02556203|2957692|Other|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.66|||=|0|2-Sided|95.0|1.05|2.62|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs >1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.||
1610005|NCT02556203|2957693|Other|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.78|||=|0|2-Sided|95.0|1.08|2.94|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs >1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.||
1610006|NCT02556203|2957694|Superiority|2-sided Log Rank test|Hazard Ratio (HR)|1.22|||=|0|2-Sided|95.0|0.89|1.69|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs >1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.||
1610007|NCT02556203|2957695|Superiority|2-sided Log Rank test|Hazard Ratio (HR)|1.39|||=|0|2-Sided|95.0|1.08|1.8|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs >1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.||
1610008|NCT02556203|2957696|Other|Descriptive. 2-sided Log Rank test.|Hazard Ratio (HR)|1.5|||=|0|2-Sided|95.0|0.95|2.37|||Log Rank||Estimates for HRs are based on Cox proportional hazards model. HRs >1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.||
1610009|NCT02556203|2957697|Superiority|2-sided Log Rank test|Hazard Ratio (HR)|1.35|||=|0|2-Sided|95.0|1.01|1.81|||Log Rank||||
1610010|NCT02556203|2957698|Non-Inferiority|1-sided Confidence interval|Hazard Ratio (HR)|1.2089302|||||1-Sided|97.5||1.7040824||||||H0: HR(t)>=1.20 for all time points t>=0, (i.e. “the hazard for the primary efficacy endpoint in the rivaroxaban-based treatment group is more than 20% larger than that in the antiplatelet-based control group”)|
1610011|NCT02555878|2957715|Superiority||Hazard Ratio (HR)|1.96|||=|0|2-Sided|95.0|0.59|6.49|||Log Rank||||
1610012|NCT02555878|2957716|Superiority||Hazard Ratio (HR)|0.33|||=|0|2-Sided|95.0|0.03|3.18|||Log Rank|||Statistical analysis for VTE-related death.|
1610013|NCT02555878|2957716|Superiority||Hazard Ratio (HR)|0.59|||=|0|2-Sided|95.0|0.21|1.62|||Log Rank|||Statistical analysis for incidental PE.|
1610014|NCT02555878|2957716|Superiority||Hazard Ratio (HR)|0.35|||=|0|2-Sided|95.0|0.11|1.11|||Log Rank|||Statistical analysis for asymptomatic lower extremity proximal DVT.|
1610015|NCT02555878|2957716|Superiority||Hazard Ratio (HR)|1.02|||=|0|2-Sided|95.0|0.29|3.52|||Log Rank|||Statistical analysis for symptomatic non-fatal PE.|
1610016|NCT02555878|2957716|Superiority||Hazard Ratio (HR)|0.67|||=|0|2-Sided|95.0|0.19|2.39|||Log Rank|||Statistical analysis for symptomatic upper extremity DVT.|
1610017|NCT02555878|2957716|Superiority||Hazard Ratio (HR)|0.4|||=|0|2-Sided|95.0|0.08|2.07|||Log Rank|||Statistical analysis for symptomatic lower extremity distal DVT.|
1610018|NCT02555878|2957716|Superiority||Hazard Ratio (HR)|1.12|||=|0|2-Sided|95.0|0.43|2.91|||Log Rank|||Statistical analysis for Symptomatic lower extremity proximal DVT.|
1610019|NCT02555878|2957716|Superiority||Hazard Ratio (HR)|0.66|||=|0|2-Sided|95.0|0.4|1.09|||Log Rank|||Statistical analysis for primary efficacy composite endpoint.|
1610247|NCT02554786|2957883|Superiority||Hazard Ratio (HR)|0.51||||0.337|2-Sided|95.0|0.13|2.03|||Regression, Cox||||
1610020|NCT02555683|2957743|Superiority||Mean Difference (Net)|0.04|Standard Error of the Mean|0.0292||0.591|2-Sided|95.0|-0.017|0.097||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure|||
1610021|NCT02555683|2957743|Superiority||Mean Difference (Net)|0.076|Standard Error of the Mean|0.0292||0.819|2-Sided|95.0|0.019|0.134||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure|||
1610022|NCT02555683|2957744|Superiority||Mean Difference (Net)|-0.19|Standard Error of the Mean|0.079||0.591|2-Sided|95.0|-0.35|-0.04||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure|||
1610023|NCT02555683|2957744|Superiority||Mean Difference (Net)|-0.11|Standard Error of the Mean|0.079||0.819|2-Sided|95.0|-0.27|0.04||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure|||
1610024|NCT02555683|2957745|Superiority||Mean Difference (Net)|0.12|Standard Error of the Mean|0.076||0.591|2-Sided|95.0|-0.03|0.27||adjusted p-vale|ANCOVA|Adjusted p-values obtained from the closed testing procedure|||
1610025|NCT02555683|2957745|Superiority||Mean Difference (Net)|0.08|Standard Error of the Mean|0.076||0.819|2-Sided|95.0|-0.07|0.23||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure|||
1610026|NCT02555683|2957746|Superiority||Rate Ratio|0.78||||0.51|2-Sided|95.0|0.61|1.01||adjusted p-value|negative binomial regression model|Adjusted p-values are based on the closed testing procedure|||
1610027|NCT02555683|2957746|Superiority||rate ratio|0.96||||0.819|2-Sided|95.0|0.75|1.22||adjusted p-value|negative binomial regression model|Adjusted p-values obtained from the closed testing procedure|||
1610028|NCT02555683|2957747|Superiority||Mean Difference (Net)|0.05|Standard Error of the Mean|0.0363||0.523|2-Sided|95.0|-0.021|0.121||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure|||
1610029|NCT02555683|2957747|Superiority||Mean Difference (Net)|0.067|Standard Error of the Mean|0.0365||0.8|2-Sided|95.0|-0.005|0.139||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure|||
1610030|NCT02555683|2957748|Superiority||Mean Difference (Net)|-0.17|Standard Error of the Mean|0.098||0.591|2-Sided|95.0|-0.37|0.02||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure|||
1610031|NCT02555683|2957748|Superiority||Mean Difference (Net)|-0.12|Standard Error of the Mean|0.098||0.819|2-Sided|95.0|-0.31|0.07||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure|||
1610032|NCT02555683|2957749|Superiority||Mean Difference (Net)|0.14|Standard Error of the Mean|0.095||0.591|2-Sided|95.0|-0.05|0.32||adjusted p-vale|ANCOVA|Adjusted p-values obtained from the closed testing procedure|||
1610033|NCT02555683|2957749|Superiority||Mean Difference (Net)|0.08|Standard Error of the Mean|0.095||0.819|2-Sided|95.0|-0.11|0.26||adjusted p-value|ANCOVA|Adjusted p-values obtained from the closed testing procedure|||
1610034|NCT02555683|2957750|Superiority||Rate Ratio|0.83||||0.51|2-Sided|95.0|0.61|1.14||adjusted p-value|negative binomial regression model|Adjusted p-values are based on the closed testing procedure|||
1610035|NCT02555683|2957750|Superiority||rate ratio|1.04||||0.8|2-Sided|95.0|0.77|1.41||adjusted p-value|negative binomial regression model|Adjusted p-values obtained from the closed testing procedure|||
1610036|NCT02555657|2957753|Superiority||Difference in percentages|-6.5||||0.9877|2-Sided|95.0|-12.2|-0.8|||Miettinen & Nurminen method||||
1610037|NCT02555657|2957754|Superiority||Difference in percentages|-1.6||||0.6701|2-Sided|95.0|-8.6|5.5|||Miettinen & Nurminen method||||
1610038|NCT02555657|2957755|Superiority||Difference in percentages|2.3||||0.3388|2-Sided|95.0|-8.7|13.5|||Miettinen & Nurminen method||||
1610039|NCT02555657|2957759|Superiority||Hazard Ratio (HR)|1.6||||1|2-Sided|95.0|1.33|1.92|||Regression, Cox||||
1610040|NCT02555657|2957760|Superiority||Hazard Ratio (HR)|1.35||||0.9964|2-Sided|95.0|1.08|1.68|||Regression, Cox||||
1610041|NCT02555657|2957761|Superiority||Hazard Ratio (HR)|1.14||||0.7936|2-Sided|95.0|0.82|1.59|||Regression, Cox||||
1610042|NCT02555657|2957762|Superiority||Difference in percentages|-1.0||||0.6629|2-Sided|95.0|-5.9|3.8|||Miettinen & Nurminen method||||
1610043|NCT02555657|2957763|Superiority||Difference in percentages|2.9||||0.1752|2-Sided|95.0|-3.3|9.2|||Miettinen & Nurminen method||||
1610044|NCT02555657|2957764|Superiority||Difference in percentages|8.3||||0.0457|2-Sided|95.0|-1.4|18.4|||Miettinen & Nurminen method||||
1610045|NCT02555657|2957765|Superiority||Hazard Ratio (HR)|0.97||||0.3802|2-Sided|95.0|0.82|1.15|||Regression, Cox||||
1610046|NCT02555657|2957766|Superiority||Hazard Ratio (HR)|0.86||||0.0728|2-Sided|95.0|0.69|1.06|||Regression, Cox||||
1610047|NCT02555657|2957767|Superiority||Hazard Ratio (HR)|0.78||||0.0574|2-Sided|95.0|0.57|1.06|||Regression, Cox||||
1610048|NCT02555618|2957777|Non-Inferiority or Equivalence|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.05|||||2-Sided|95.0|0.9622|1.1427|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.|
1610049|NCT02555618|2957777|Non-Inferiority or Equivalence|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.98|||||2-Sided|95.0|0.8686|1.0969|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2-Day 22.|
1610050|NCT02555618|2957777|Non-Inferiority or Equivalence|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||2-Sided|95.0|0.9106|1.2484|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.|
1610051|NCT02555618|2957778|Non-Inferiority or Equivalence|Non inferiority margin is set to -20%.|Rate difference|3.2|||||2-Sided|95.0|-6.406|12.757|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.|
1610052|NCT02555618|2957778|Non-Inferiority or Equivalence|Non inferiority margin is set to -20%.|Rate difference|-0.8|||||2-Sided|95.0|-10.369|8.803|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.|
1610053|NCT02555618|2957778|Non-Inferiority or Equivalence|Non inferiority margin is set to -20%.|Rate difference|1.1|||||2-Sided|95.0|-7.195|9.423|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.|
1610054|NCT02555618|2957781|Non-Inferiority or Equivalence|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||2-Sided|95.0|0.8166|1.3934|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.|
1610055|NCT02555618|2957781|Non-Inferiority or Equivalence|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.07|||||2-Sided|95.0|0.7806|1.4564|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.|
1610056|NCT02555618|2957781|Non-Inferiority or Equivalence|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.48|||||2-Sided|95.0|1.1221|1.9623|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.|
1610057|NCT02555618|2957782|Non-Inferiority or Equivalence|Non inferiority margin is set to -20%.|Rate difference|-2.4|||||2-Sided|95.0|-10.346|5.579||||||The analysis is difference of seroconversion rate between treatment groups for B-Strain.|
1610058|NCT02555618|2957782|Non-Inferiority or Equivalence|Non inferiority margin is set to -20%.|Rate difference|-1.9|||||2-Sided|95.0|-10.614|6.928||||||The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.|
1610059|NCT02555618|2957782|Non-Inferiority or Equivalence|Non inferiority margin is set to -20%.|Rate difference|14.7|||||2-Sided|95.0|5.489|23.577||||||The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.|
1610060|NCT02555618|2957785|Non-Inferiority or Equivalence|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.98|||||2-Sided|95.0|0.9273|1.0364|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.|
1610061|NCT02555618|2957785|Non-Inferiority or Equivalence|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.9|||||2-Sided|95.0|0.7862|1.0241|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.|
1610062|NCT02555618|2957785|Non-Inferiority or Equivalence|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.05|||||2-Sided|95.0|0.9559|1.1473|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.|
1610063|NCT02555618|2957786|Non-Inferiority or Equivalence|Non inferiority margin is set to -20%.|Rate difference|-2.3|||||2-Sided|95.0|-11.461|6.835||||||The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.|
1610064|NCT02555618|2957786|Non-Inferiority or Equivalence|Non inferiority margin is set to -20%.|Rate difference|-8.8|||||2-Sided|95.0|-18.282|0.901||||||The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.|
1610065|NCT02555618|2957786|Non-Inferiority or Equivalence|Non inferiority margin is set to -20%.|Rate difference|6.8|||||2-Sided|95.0|-3.02|16.348||||||The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.|
1610066|NCT02555618|2957789|Non-Inferiority or Equivalence|Non inferiority margin is set to 0.5.|Ratio of GMTs|1.06|||||2-Sided|95.0|0.8134|1.3931|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for B Strain-Day 22.|
1610067|NCT02555618|2957789|Non-Inferiority or Equivalence|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.76|||||2-Sided|95.0|0.5544|1.05|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H3N2 Strain-Day 22.|
1610068|NCT02555618|2957789|Non-Inferiority or Equivalence|Non inferiority margin is set to 0.5.|Ratio of GMTs|0.99|||||2-Sided|95.0|0.7984|1.2253|||||TAK-850/Influenza HA Vaccine|The analysis is Geometric Mean Ratio between treatment groups for A/H1N1 Strain-Day 22.|
1610069|NCT02555618|2957790|Non-Inferiority or Equivalence|Non inferiority margin is set to -20%.|Rate difference|2.6|||||2-Sided|95.0|-6.082|11.32|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for B Strain-Day 22.|
1610070|NCT02555618|2957790|Non-Inferiority or Equivalence|Non inferiority margin is set to -20%.|Rate difference|-4.8|||||2-Sided|95.0|-13.974|4.403|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H3N2 Strain-Day 22.|
1610071|NCT02555618|2957790|Non-Inferiority or Equivalence|Non inferiority margin is set to -20%.|Rate difference|1.7|||||2-Sided|95.0|-7.983|11.415|||||TAK-850 - Influenza HA Vaccine|The analysis is difference of seroconversion rate between treatment groups for A/H1N1 Strain-Day 22.|
1610072|NCT02555371|2957791|Superiority||Hazard Ratio (HR)|1.33||||0.57|2-Sided|95.0|0.5|3.51|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.||
1610073|NCT02555371|2957792|Superiority||Hazard Ratio (HR)|0.66||||0.005|2-Sided|95.0|0.49|0.88|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.||
1610074|NCT02555371|2957793|Superiority||Ratio|0.16|||<|0.001|2-Sided|95.0|0.13|0.2|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 52 has been presented.||
1610075|NCT02555371|2957793|Superiority||Ratio|0.19|||<|0.001|2-Sided|95.0|0.15|0.24|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 36 has been presented.||
1610076|NCT02555371|2957793|Superiority||Ratio|0.16|||<|0.001|2-Sided|95.0|0.12|0.2|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 24 has been presented.||
1610077|NCT02555371|2957793|Superiority||Ratio|0.19|||<|0.001|2-Sided|95.0|0.15|0.24|||Mixed model repeated measures||Treatment comparison between mepolizumab 100 mg SC and placebo using ratio of mepolizumab to placebo and its 95% confidence interval at Week 12 has been presented.||
1610078|NCT02555371|2957794|Superiority||Hazard Ratio (HR)|0.62||||0.004|2-Sided|95.0|0.45|0.86|||Cox Proportional Hazards Model||Treatment comparison between mepolizumab 100 mg SC and placebo using hazards ratio and 95% confidence interval has been presented.||
1610093|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|1.05|Standard Error of the Mean|0.34||0.0024|2-Sided|90.0|0.48|1.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)|
1610248|NCT02554786|2957884|Superiority||Hazard Ratio (HR)|0.84||||0.185|2-Sided|95.0|0.66|1.08|||Regression, Cox|||All asthma exacerbation|
1610445|NCT02553538|2957986|Superiority or Other||||||<|0.001|||||||Regression, Logistic||||
1610079|NCT02554929|2957832|Superiority||Mean Difference (Final Values)|1.89|Standard Error of the Mean|3.14||0.002|2-Sided|95.0|-4.28|8.08||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||The estimated value of the estimation parameter corresponds to the difference between change in CGAS scores for participants in the CBT arm, in comparison to those in the socialization arm, from pre-treatment to 6-month follow-up.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.|
1610080|NCT02554929|2957835|Superiority||Mean Difference (Final Values)|0.27|Standard Error of the Mean|0.62||0.002|2-Sided|95.0|-0.95|1.48||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SM.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.|
1610081|NCT02554929|2957835|Superiority||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.42||0.002|2-Sided|95.0|-0.91|0.74||P value adjusted for multiple comparison; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||Values above are for the primary outcome measure of the Anxiety Disorders Interview Schedule for DSM-IV, Clinical Severity Rating (ADIS-CSR) score for SAD.|In our previous study, 42% participants in the CBT arm lost their primary diagnosis of social anxiety disorder (SAD) and/or selective mutism (SM) post-intervention versus none of the comparison group participants. In the present study, we conservatively estimated that 10% of comparison group children will lose their primary diagnosis. A sample size of 70 achieves a power of 81% to detect a 32% difference between treatments, using a two-sided Chi-squared test with a significance level of 0.05.|
1610082|NCT02554890|2957836|Other||expon. back transformed from LS means|0.7133|||<|0.0001|2-Sided|95.0|0.6171|0.8245||ANCOVA model for a log-scaled response with treatment group as a class variable and biomarker baseline value in logarithmic scale as a continuous covariate.|ANCOVA||Geometric Mean Ratio: Sacubitril/Valsartan vs. Enalapril||
1610083|NCT02554890|2957837|Other||expon. back transformed from LS means|1.4745|||<|0.0001|2-Sided|95.0|1.3752|1.581|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril||
1610084|NCT02554890|2957838|Other||expon. back transformed from LS means|1.4186|||<|0.0001|2-Sided|95.0|1.3248|1.519|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril||
1610085|NCT02554890|2957839|Other||expon. back transformed from LS means|1.6487|||<|0.0001|2-Sided|95.0|1.4559|1.8669|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril||
1610086|NCT02554890|2957840|Other||exponentially back transformed from LS m|0.8487||||0.0011|2-Sided|95.0|0.7694|0.9361|||ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril||
1610087|NCT02554890|2957844|Other||expon. back transformed from LS means|0.7143|||<|0.0001|2-Sided|95.0|0.6315|0.808||ANCOVA model for a log-scaled response with treatment group as a class variable and biomarker baseline value in logarithmic scale as a continuous covariate.|ANCOVA||Geometric Mean Ratio: Sacubitril/ Valsartan vs. Enalapril||
1610088|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|0.97|Standard Error of the Mean|0.45||0.0344|2-Sided|90.0|0.22|1.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)|
1610089|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|1.15|Standard Error of the Mean|0.45||0.0115|2-Sided|90.0|0.4|1.89||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)|
1610090|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|1.39|Standard Error of the Mean|0.45||0.0024|2-Sided|90.0|0.65|2.14||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)|
1610091|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|0.86|Standard Error of the Mean|0.34||0.0132|2-Sided|90.0|0.29|1.42||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)|
1610092|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|0.92|Standard Error of the Mean|0.34||0.0068|2-Sided|90.0|0.37|1.48||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)|
1610240|NCT02554786|2957882|Superiority||Rate Ratio|0.46|||<|0.001|2-Sided|95.0|0.31|0.67|||Generalized linear model|||Severe asthma exacerbation|
1610241|NCT02554786|2957882|Superiority||Rate Ratio|0.71|||<|0.108|2-Sided|95.0|0.47|1.08|||Generalized linear model|||Severe asthma exacerbation|
1610094|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|0.48|Standard Error of the Mean|0.28||0.0862|2-Sided|90.0|0.02|0.93||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)|
1610095|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|0.57|Standard Error of the Mean|0.27||0.0394|2-Sided|90.0|0.12|1.02||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation.(Excluding outliers)|
1610096|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|0.8|Standard Error of the Mean|0.27||0.0038|2-Sided|90.0|0.35|1.25||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)|
1610097|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|0.34|Standard Error of the Mean|0.26||0.193|2-Sided|90.0|-0.09|0.77||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)|
1610098|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|0.0|Standard Error of the Mean|0.26||0.9912|2-Sided|90.0|-0.42|0.43||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)|
1610099|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|0.3|Standard Error of the Mean|0.26||0.2391|2-Sided|90.0|-0.12|0.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2. The readings with residual greater than 3.5 times of its standard derivation were excluded from the presentation. (Excluding outliers)|
1610100|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|1.4|Standard Error of the Mean|0.51||0.0073|2-Sided|90.0|0.55|2.25||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610101|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|1.18|Standard Error of the Mean|0.51||0.0225|2-Sided|90.0|0.33|2.02||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610102|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|1.41|Standard Error of the Mean|0.51||0.0067|2-Sided|90.0|0.56|2.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610103|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|1.31|Standard Error of the Mean|0.42||0.0021|2-Sided|90.0|0.62|2.01||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610104|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|0.97|Standard Error of the Mean|0.42||0.022|2-Sided|90.0|0.27|1.66||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610105|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|1.07|Standard Error of the Mean|0.42||0.0116|2-Sided|90.0|0.38|1.76||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610106|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|1.39|Standard Error of the Mean|0.49||0.0047|2-Sided|90.0|0.58|2.19||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610107|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|1.08|Standard Error of the Mean|0.48||0.0268|2-Sided|90.0|0.28|1.88||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610108|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|1.28|Standard Error of the Mean|0.48||0.0087|2-Sided|90.0|0.48|2.08||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610434|NCT02553746|2957975|Superiority|||||||0.162|||||||Wilcoxon (Mann-Whitney)||||
1610109|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|0.87|Standard Error of the Mean|0.41||0.0345|2-Sided|90.0|0.19|1.54||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610110|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|0.06|Standard Error of the Mean|0.4||0.8789|2-Sided|90.0|-0.61|0.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610111|NCT02554877|2957845|Superiority or Other||LS Mean difference from placebo|0.34|Standard Error of the Mean|0.4||0.402|2-Sided|90.0|-0.33|1.01||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610112|NCT02554877|2957846|Superiority or Other||LS Mean difference from placebo|0.88|Standard Error of the Mean|3.72||0.8129|2-Sided|90.0|-5.27|7.04||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610113|NCT02554877|2957846|Superiority or Other||LS Mean difference from placebo|3.82|Standard Error of the Mean|3.7||0.3031|2-Sided|90.0|-2.3|9.94||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610114|NCT02554877|2957846|Superiority or Other||LS Mean difference from placebo|3.54|Standard Error of the Mean|3.74||0.3443|2-Sided|90.0|-2.64|9.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610115|NCT02554877|2957846|Superiority or Other||LS Mean difference from placebo|-4.17|Standard Error of the Mean|3.36||0.216|2-Sided|90.0|-9.73|1.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610116|NCT02554877|2957846|Superiority or Other||LS Mean difference from placebo|-5.31|Standard Error of the Mean|3.33||0.1126|2-Sided|90.0|-10.81|0.2||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610117|NCT02554877|2957846|Superiority or Other||LS Mean difference from placebo|-2.94|Standard Error of the Mean|3.36||0.3827|2-Sided|90.0|-8.48|2.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610118|NCT02554877|2957846|Superiority or Other||LS Mean difference from placebo|-6.49|Standard Error of the Mean|3.39||0.0568|2-Sided|90.0|-12.08|-0.89||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610119|NCT02554877|2957846|Superiority or Other||LS Mean difference from placebo|-4.33|Standard Error of the Mean|3.38||0.2016|2-Sided|90.0|-9.92|1.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610120|NCT02554877|2957846|Superiority or Other||LS Mean difference from placebo|-1.83|Standard Error of the Mean|3.38||0.5877|2-Sided|90.0|-7.42|3.75||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610121|NCT02554877|2957846|Superiority or Other||LS Mean difference from placebo|3.11|Standard Error of the Mean|3.33||0.3516|2-Sided|90.0|-2.39|8.61||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610122|NCT02554877|2957846|Superiority or Other||LS Mean difference from placebo|1.02|Standard Error of the Mean|3.31||0.7583|2-Sided|90.0|-4.45|6.49||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610123|NCT02554877|2957846|Superiority or Other||LS Mean difference from placebo|1.46|Standard Error of the Mean|3.31||0.6597|2-Sided|90.0|-4.01|6.92||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610124|NCT02554877|2957847|Superiority or Other||LS Mean difference from placebo|10.83|Standard Error of the Mean|2.77||0.0001|2-Sided|90.0|6.24|15.42||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610242|NCT02554786|2957882|Superiority||Rate Ratio|0.93|||<|0.669|2-Sided|95.0|0.67|1.29|||Generalized linear model|||Moderate or severe asthma exacerbation|
1610243|NCT02554786|2957882|Superiority||Rate Ratio|0.47|||<|0.001|2-Sided|95.0|0.35|0.64|||Generalized linear model|||Moderate or severe asthma exacerbation|
1610125|NCT02554877|2957847|Superiority or Other||LS Mean difference from placebo|7.41|Standard Error of the Mean|2.75||0.0079|2-Sided|90.0|2.85|11.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610126|NCT02554877|2957847|Superiority or Other||LS Mean difference from placebo|6.96|Standard Error of the Mean|2.78||0.0132|2-Sided|90.0|2.36|11.56||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610127|NCT02554877|2957847|Superiority or Other||LS Mean difference from placebo|10.14|Standard Error of the Mean|2.51|<|0.0001|2-Sided|90.0|5.98|14.3||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610128|NCT02554877|2957847|Superiority or Other||LS Mean difference from placebo|4.39|Standard Error of the Mean|2.48|<|0.0789|2-Sided|90.0|0.28|8.49||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610129|NCT02554877|2957847|Superiority or Other||LS Mean difference from placebo|3.59|Standard Error of the Mean|2.51|<|0.1538|2-Sided|90.0|-0.55|7.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610130|NCT02554877|2957847|Superiority or Other||LS Mean difference from placebo|7.88|Standard Error of the Mean|2.56|<|0.0024|2-Sided|90.0|3.65|12.11||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610131|NCT02554877|2957847|Superiority or Other||LS Mean difference from placebo|3.62|Standard Error of the Mean|2.55|<|0.1573|2-Sided|90.0|-0.6|7.84||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610132|NCT02554877|2957847|Superiority or Other||LS Mean difference from placebo|0.37|Standard Error of the Mean|2.55|<|0.8837|2-Sided|90.0|-3.85|4.59||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610133|NCT02554877|2957847|Superiority or Other||LS Mean difference from placebo|8.45|Standard Error of the Mean|2.18|<|0.0002|2-Sided|90.0|4.84|12.06||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610134|NCT02554877|2957847|Superiority or Other||LS Mean difference from placebo|2.97|Standard Error of the Mean|2.17|<|0.1729|2-Sided|90.0|-0.62|6.55||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610135|NCT02554877|2957847|Superiority or Other||LS Mean difference from placebo|0.39|Standard Error of the Mean|2.17|<|0.8559|2-Sided|90.0|-3.19|3.98||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610136|NCT02554877|2957848|Superiority or Other||LS Mean difference from placebo|3.79|Standard Error of the Mean|2.85||0.1851|2-Sided|90.0|-0.92|8.5||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610137|NCT02554877|2957848|Superiority or Other||LS Mean difference from placebo|4.7|Standard Error of the Mean|2.83||0.0986|2-Sided|90.0|0.02|9.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610138|NCT02554877|2957848|Superiority or Other||LS Mean difference from placebo|4.23|Standard Error of the Mean|2.86||0.1408|2-Sided|90.0|-0.5|8.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610139|NCT02554877|2957848|Superiority or Other||LS Mean difference from placebo|0.08|Standard Error of the Mean|2.57||0.9751|2-Sided|90.0|-4.16|4.32||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610140|NCT02554877|2957848|Superiority or Other||LS Mean difference from placebo|-2.64|Standard Error of the Mean|2.54||0.2993|2-Sided|90.0|-6.84|1.56||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610141|NCT02554877|2957848|Superiority or Other||LS Mean difference from placebo|-0.98|Standard Error of the Mean|2.56||0.7036|2-Sided|90.0|-5.21|3.26||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610142|NCT02554877|2957848|Superiority or Other||LS Mean difference from placebo|-2.03|Standard Error of the Mean|2.49||0.4173|2-Sided|90.0|-6.15|2.09||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610143|NCT02554877|2957848|Superiority or Other||LS Mean difference from placebo|-1.95|Standard Error of the Mean|2.49||0.4346|2-Sided|90.0|-6.06|2.16||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610144|NCT02554877|2957848|Superiority or Other||LS Mean difference from placebo|-0.62|Standard Error of the Mean|2.48||0.8021|2-Sided|90.0|-4.73|3.48||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610145|NCT02554877|2957848|Superiority or Other||LS Mean difference from placebo|4.66|Standard Error of the Mean|2.53||0.0676|2-Sided|90.0|0.47|8.85||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610146|NCT02554877|2957848|Superiority or Other||LS Mean difference from placebo|1.64|Standard Error of the Mean|2.52||0.515|2-Sided|90.0|-2.52|5.8||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610147|NCT02554877|2957848|Superiority or Other||LS Mean difference from placebo|1.04|Standard Error of the Mean|2.52||0.68|2-Sided|90.0|-3.12|5.2||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610148|NCT02554877|2957849|Superiority or Other||Median Difference (Net)|5.99|||||2-Sided|90.0|-7.07|19.04||||||Placebo was the reference and each of the active doses was the test for Week 12.|
1610149|NCT02554877|2957849|Superiority or Other||Median Difference (Net)|-1.13|||||2-Sided|90.0|-16.13|13.87||||||Placebo was the reference and each of the active doses was the test for Week 12.|
1610150|NCT02554877|2957849|Superiority or Other||Median Difference (Net)|7.86|||||2-Sided|90.0|-3.3|19.02||||||Placebo was the reference and each of the active doses was the test for Week 12.|
1610151|NCT02554877|2957849|Superiority or Other||Median Difference (Net)|2.75|||||2-Sided|90.0|-13.66|19.16||||||Placebo was the reference and each of the active doses was the test for Week 8.|
1610152|NCT02554877|2957849|Superiority or Other||Median Difference (Net)|-4.59|||||2-Sided|90.0|-20.4|11.22||||||Placebo was the reference and each of the active doses was the test for Week 8.|
1610153|NCT02554877|2957849|Superiority or Other||Median Difference (Net)|-1.63|||||2-Sided|90.0|-16.29|13.03||||||Placebo was the reference and each of the active doses was the test for Week 8.|
1610154|NCT02554877|2957849|Superiority or Other||Median Difference (Net)|-2.57|||||2-Sided|90.0|-15.08|9.94||||||Placebo was the reference and each of the active doses was the test for Week 4.|
1610155|NCT02554877|2957849|Superiority or Other||Median Difference (Net)|2.92|||||2-Sided|90.0|-10.61|16.45||||||Placebo was the reference and each of the active doses was the test for Week 4.|
1610156|NCT02554877|2957849|Superiority or Other||Median Difference (Net)|2.71|||||2-Sided|90.0|-10.8|16.22||||||Placebo was the reference and each of the active doses was the test for Week 4.|
1610157|NCT02554877|2957849|Superiority or Other||Median Difference (Net)|17.13|||||2-Sided|90.0|3.91|30.34||||||Placebo was the reference and each of the active doses was the test for Week 2.|
1610158|NCT02554877|2957849|Superiority or Other||Median Difference (Net)|2.86|||||2-Sided|90.0|-9.76|15.48||||||Placebo was the reference and each of the active doses was the test for Week 2.|
1610159|NCT02554877|2957849|Superiority or Other||Median Difference (Net)|5.09|||||2-Sided|90.0|-5.86|16.05||||||Placebo was the reference and each of the active doses was the test for Week 2.|
1610160|NCT02554877|2957850|Superiority or Other||LS Mean difference from placebo|2.29|Standard Error of the Mean|3.92||0.5592|2-Sided|90.0|-4.19|8.78||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610161|NCT02554877|2957850|Superiority or Other||LS Mean difference from placebo|4.96|Standard Error of the Mean|3.89||0.2038|2-Sided|90.0|-1.47|11.4||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610162|NCT02554877|2957850|Superiority or Other||LS Mean difference from placebo|3.15|Standard Error of the Mean|3.95||0.4266|2-Sided|90.0|-3.39|9.69||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610163|NCT02554877|2957850|Superiority or Other||LS Mean difference from placebo|-1.81|Standard Error of the Mean|3.74||0.6295|2-Sided|90.0|-7.99|4.37||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610164|NCT02554877|2957850|Superiority or Other||LS Mean difference from placebo|-2.46|Standard Error of the Mean|3.7||0.5075|2-Sided|90.0|-8.57|3.66||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610165|NCT02554877|2957850|Superiority or Other||LS Mean difference from placebo|-1.25|Standard Error of the Mean|3.73||0.7373|2-Sided|90.0|-7.42|4.92||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610166|NCT02554877|2957850|Superiority or Other||LS Mean difference from placebo|-4.83|Standard Error of the Mean|3.28||0.143|2-Sided|90.0|-10.26|0.6||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610167|NCT02554877|2957850|Superiority or Other||LS Mean difference from placebo|-3.45|Standard Error of the Mean|3.27||0.2927|2-Sided|90.0|-8.85|1.95||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610168|NCT02554877|2957850|Superiority or Other||LS Mean difference from placebo|-2.22|Standard Error of the Mean|3.27||0.4979|2-Sided|90.0|-7.63|3.19||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610169|NCT02554877|2957850|Superiority or Other||LS Mean difference from placebo|2.47|Standard Error of the Mean|3.42||0.4699|2-Sided|90.0|-3.17|8.12||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610170|NCT02554877|2957850|Superiority or Other||LS Mean difference from placebo|-0.65|Standard Error of the Mean|3.39||0.8489|2-Sided|90.0|-6.25|4.96||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610171|NCT02554877|2957850|Superiority or Other||LS Mean difference from placebo|-1.03|Standard Error of the Mean|3.4||0.7618|2-Sided|90.0|-6.66|4.59||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610172|NCT02554877|2957855|Superiority or Other||Odds Ratio (OR)|5.588||||0.0272|2-Sided|95.0|1.21|25.73||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C<6.5%)|
1610173|NCT02554877|2957855|Superiority or Other||Risk Ratio (RR)|4.198||||0.0826|2-Sided|95.0|0.83|21.22||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C<6.5%)|
1610174|NCT02554877|2957855|Superiority or Other||Odds Ratio (OR)|3.34||||0.1532|2-Sided|95.0|0.64|17.47||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C<6.5%)|
1610175|NCT02554877|2957855|Superiority or Other||Odds Ratio (OR)|15.116|||<|0.0001|2-Sided|95.0|4.34|52.67||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C<7%)|
1610176|NCT02554877|2957855|Superiority or Other||Odds Ratio (OR)|8.927|||<|0.0008|2-Sided|95.0|2.49|31.96||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C<7%)|
1610177|NCT02554877|2957855|Superiority or Other||Odds Ratio (OR)|6.057|||<|0.0059|2-Sided|95.0|1.68|21.82||P-value was derived from the logistic regression model with treatment (categorical) and baseline HbA1c as covariate.|Regression, Logistic|||Placebo was the reference and each of the active doses was the test for Week 12 (HbA1C<7%)|
1610178|NCT02554877|2957856|Superiority or Other||LS Mean difference from placebo|-36.44|Standard Error of the Mean|6.07|<|0.0001|2-Sided|95.0|-48.43|-24.46||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12|
1610179|NCT02554877|2957856|Superiority or Other||LS Mean difference from placebo|-35.26|Standard Error of the Mean|6.03|<|0.0001|2-Sided|95.0|-47.17|-23.35||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12|
1610180|NCT02554877|2957856|Superiority or Other||LS Mean difference from placebo|-19.77|Standard Error of the Mean|6.1|<|0.0014|2-Sided|95.0|-31.81|-7.73||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610181|NCT02554877|2957856|Superiority or Other||LS Mean difference from placebo|-35.14|Standard Error of the Mean|6.29|<|0.0001|2-Sided|95.0|-47.55|-22.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610182|NCT02554877|2957856|Superiority or Other||LS Mean difference from placebo|-36.98|Standard Error of the Mean|6.23|<|0.0001|2-Sided|95.0|-49.27|-24.69||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610183|NCT02554877|2957856|Superiority or Other||LS Mean difference from placebo|-19.47|Standard Error of the Mean|6.29|<|0.0023|2-Sided|95.0|-31.88|-7.05||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 8.|
1610184|NCT02554877|2957856|Superiority or Other||LS Mean difference from placebo|-38.3|Standard Error of the Mean|6.04|<|0.0001|2-Sided|95.0|-50.22|-26.38||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610185|NCT02554877|2957856|Superiority or Other||LS Mean difference from placebo|-39.24|Standard Error of the Mean|6.03|<|0.0001|2-Sided|95.0|-51.13|-27.35||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610186|NCT02554877|2957856|Superiority or Other||LS Mean difference from placebo|-30.63|Standard Error of the Mean|6.03|<|0.0001|2-Sided|95.0|-42.52|-18.74||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 4.|
1610187|NCT02554877|2957856|Superiority or Other||LS Mean difference from placebo|-48.59|Standard Error of the Mean|5.18|<|0.0001|2-Sided|95.0|-58.81|-38.37||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610188|NCT02554877|2957856|Superiority or Other||LS Mean difference from placebo|-44.85|Standard Error of the Mean|5.13|<|0.0001|2-Sided|95.0|-54.98|-34.72||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610189|NCT02554877|2957856|Superiority or Other||LS Mean difference from placebo|-37.83|Standard Error of the Mean|5.13|<|0.0001|2-Sided|95.0|-47.96|-27.7||Two (2)-sided p-values were from MMRM with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 2.|
1610190|NCT02554877|2957857|Superiority or Other||LS Mean difference from placebo|-0.98|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-1.2|-0.76||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 8.|
1610191|NCT02554877|2957857|Superiority or Other||LS Mean difference from placebo|-0.96|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-1.17|-0.74||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects..|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 8.|
1610192|NCT02554877|2957857|Superiority or Other||LS Mean difference from placebo|-0.71|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-0.93|-0.49||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model||Placebo was the reference and each of the active doses was the test for Week 8.|
1610193|NCT02554877|2957857|Superiority or Other||LS Mean difference from placebo|-0.62|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.79|-0.46||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.|
1610194|NCT02554877|2957857|Superiority or Other||LS Mean difference from placebo|-0.63|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.8|-0.46||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.|
1610195|NCT02554877|2957857|Superiority or Other||LS Mean difference from placebo|-0.59|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.76|-0.42||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 4.|
1610196|NCT02554877|2957857|Superiority or Other||LS Mean difference from placebo|-0.44|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|-0.57|-0.3||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 2.|
1610197|NCT02554877|2957857|Superiority or Other||LS Mean difference from placebo|-0.39|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|-0.52|-0.26||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects|ANCOVA|LS mean difference from placebo adjusted for baseline values was derived from the ANCOVA model.||Placebo was the reference and each of the active doses was the test for Week 2.|
1610198|NCT02554877|2957857|Superiority or Other||LS Mean difference from placebo|-0.39|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|-0.52|-0.26||Two (2)-sided p-values were from analysis of covariance (ANCOVA) model with baseline value and treatment group as fixed effects|ANCOVA|Least squares mean (LS mean) difference from placebo adjusted for baseline values was derived from the ANCOVA model||Placebo was the reference and each of the active doses was the test for Week 2.|
1610244|NCT02554786|2957882|Superiority||Rate Ratio|0.65|||<|0.008|2-Sided|95.0|0.48|0.89|||Generalized linear model|||Moderate or severe asthma exacerbation|
1610199|NCT02554877|2957858|Superiority or Other||LS Mean difference from placebo|-1.17|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.6|-0.74||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12.|
1610200|NCT02554877|2957858|Superiority or Other||LS Mean difference from placebo|-1.16|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.59|-0.73||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12|
1610201|NCT02554877|2957858|Superiority or Other||LS Mean difference from placebo|-0.91|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.34|-0.48||Two (2)-sided p-values were from mixed model for repeated measurements (MMRM) with baseline value, time (study day), treatment group, time by treatment interaction as fixed effects and an unstructured correlation matrix.|Mixed Models Analysis|||Placebo was the reference and each of the active doses was the test for Week 12|
1610202|NCT02554786|2957874|Non-Inferiority|QMF 150/320 was considered non-inferior to S/F 50/500 if the lower bound of the 95% CI was above the non-inferiority margin of -90 mL and was considered superior if the lower bound of the 95% CI was > 0. The p-value is for null-hypothesis testing.|LS Mean|0.036|Standard Error of the Mean|0.0222||0.101|2-Sided|95.0|-0.007|0.08|||MMRM||||
1610203|NCT02554786|2957875|Superiority||LS Mean|0.041|Standard Error of the Mean|0.0548||0.455|2-Sided|95.0|-0.067|0.148|||MMRM|||Day 364|
1610204|NCT02554786|2957875|Superiority||LS Mean|0.191|Standard Error of the Mean|0.0553|<|0.001|2-Sided|95.0|0.082|0.299|||MMRM|||Day 364|
1610205|NCT02554786|2957875|Superiority||LS Mean|0.079|Standard Error of the Mean|0.0552|<|0.154|2-Sided|95.0|-0.03|0.187|||MMRM|||Day 364|
1610206|NCT02554786|2957875|Superiority||LS Mean|0.061|Standard Error of the Mean|0.0538|<|0.258|2-Sided|95.0|-0.045|0.166|||MMRM|||Day 254|
1610207|NCT02554786|2957875|Superiority||LS Mean|0.168|Standard Error of the Mean|0.0543|<|0.002|2-Sided|95.0|0.061|0.274|||MMRM|||Day 254|
1610208|NCT02554786|2957875|Superiority||LS Mean|0.071|Standard Error of the Mean|0.0542|<|0.188|2-Sided|95.0|-0.035|0.178|||MMRM|||Day 254|
1610209|NCT02554786|2957875|Superiority||LS Mean|0.085|Standard Error of the Mean|0.0525|<|0.103|2-Sided|95.0|-0.017|0.188|||MMRM|||Day 183|
1610210|NCT02554786|2957875|Superiority||LS Mean|0.156|Standard Error of the Mean|0.0529|<|0.003|2-Sided|95.0|0.053|0.26|||MMRM|||Day 183|
1610211|NCT02554786|2957875|Superiority||LS Mean|0.127|Standard Error of the Mean|0.0526|<|0.016|2-Sided|95.0|0.023|0.23|||MMRM|||Day 183|
1610212|NCT02554786|2957875|Superiority||LS Mean|0.026|Standard Error of the Mean|0.0501|<|0.598|2-Sided|95.0|-0.072|0.125|||MMRM|||Day 86|
1610213|NCT02554786|2957875|Superiority||LS Mean|0.118|Standard Error of the Mean|0.0507|<|0.02|2-Sided|95.0|0.019|0.217|||MMRM|||Day 86|
1610214|NCT02554786|2957875|Superiority||LS Mean|0.054|Standard Error of the Mean|0.0503|<|0.28|2-Sided|95.0|-0.044|0.153|||MMRM|||Day 86|
1610215|NCT02554786|2957875|Superiority||LS Mean|0.045|Standard Error of the Mean|0.046|<|0.33|2-Sided|95.0|-0.045|0.135|||MMRM|||Day 30|
1610216|NCT02554786|2957875|Superiority||LS Mean|0.123|Standard Error of the Mean|0.0464|<|0.008|2-Sided|95.0|0.032|0.214|||MMRM|||Day 30|
1610217|NCT02554786|2957875|Superiority||LS Mean|0.147|Standard Error of the Mean|0.0462|<|0.002|2-Sided|95.0|0.056|0.237|||MMRM|||Day 30|
1610218|NCT02554786|2957876|Superiority||LS Mean|4.3|Standard Error of the Mean|2.04||0.034|2-Sided|95.0|0.3|8.3|||LMM|||Weeks 1-52|
1610219|NCT02554786|2957876|Superiority||LS Mean|8.6|Standard Error of the Mean|2.03|<|0.001|2-Sided|95.0|4.7|12.6|||LMM|||Weeks 1-52|
1610220|NCT02554786|2957876|Superiority||LS Mean|9.6|Standard Error of the Mean|2.03|<|0.001|2-Sided|95.0|5.7|13.6|||LMM|||Weeks 1-52|
1610221|NCT02554786|2957876|Superiority||LS Mean|4.1|Standard Error of the Mean|2.02|<|0.045|2-Sided|95.0|0.1|8.0|||LMM|||Weeks 1-26|
1610222|NCT02554786|2957876|Superiority||LS Mean|8.3|Standard Error of the Mean|2.02|<|0.001|2-Sided|95.0|4.3|12.3|||LMM|||Weeks 1-26|
1610223|NCT02554786|2957876|Superiority||LS Mean|10.1|Standard Error of the Mean|2.02|<|0.001|2-Sided|95.0|6.2|14.1|||LMM|||Weeks 1-26|
1610224|NCT02554786|2957879|Superiority||Hazard Ratio (HR)|0.54||||0.618|2-Sided|95.0|0.05|6.01|||Regression, Cox||||
1610225|NCT02554786|2957879|Superiority||Hazard Ratio (HR)|0.0||||0.992|2-Sided|95.0|0.0||The upper limit of CI could not be calculated due to low number of participants with asthma exacerbation.||Regression, Cox||||
1610226|NCT02554786|2957879|Superiority||Hazard Ratio (HR)|0.26||||0.222|2-Sided|95.0|0.03|2.29|||Regression, Cox||||
1610227|NCT02554786|2957881|Superiority|||||||0.074|||||||van Elteren test|||All (mild, moderate, severe) asthma exacerbation|
1610228|NCT02554786|2957881|Superiority||||||<|0.001|||||||Van Elteren Test|||All (mild, moderate, severe) Asthma Exacerbation|
1610229|NCT02554786|2957881|Superiority||||||<|0.002|||||||Van Elteren Test|||All(mild, moderate, severe) Asthma Exacerbation|
1610230|NCT02554786|2957881|Superiority||||||<|0.025|||||||van Elteren test|||Severe asthma exacerbation|
1610231|NCT02554786|2957881|Superiority||||||<|0.001|||||||Van Elteren Test|||Severe Asthma Exacerbation|
1610232|NCT02554786|2957881|Superiority||||||<|0.004|||||||Van Elteren Test|||Severe Asthma Exacerbation|
1610233|NCT02554786|2957881|Superiority||||||<|0.059|||||||van Elteren test|||Moderate or severe asthma exacerbation|
1610234|NCT02554786|2957881|Superiority||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation|
1610235|NCT02554786|2957881|Superiority||||||<|0.001|||||||van Elteren test|||Moderate or severe asthma exacerbation|
1610236|NCT02554786|2957882|Superiority||Rate Ratio|0.95||||0.681|2-Sided|95.0|0.72|1.23|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation|
1610237|NCT02554786|2957882|Superiority||Rate Ratio|0.46|||<|0.001|2-Sided|95.0|0.36|0.59|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation|
1610238|NCT02554786|2957882|Superiority||Rate Ratio|0.67|||<|0.002|2-Sided|95.0|0.52|0.87|||Generalized linear model|||All (mild, moderate, severe) asthma exacerbation|
1610239|NCT02554786|2957882|Superiority||Rate Ratio|0.89|||<|0.597|2-Sided|95.0|0.58|1.37|||Generalized linear model|||Severe asthma exacerbation|
1610249|NCT02554786|2957884|Superiority||Hazard Ratio (HR)|0.48|||<|0.001|2-Sided|95.0|0.38|0.6|||Regression, Cox|||All asthma exacerbation|
1610250|NCT02554786|2957884|Superiority||Hazard Ratio (HR)|0.65|||<|0.001|2-Sided|95.0|0.51|0.82|||Regression, Cox|||All asthma exacerbation|
1610251|NCT02554786|2957884|Superiority||Hazard Ratio (HR)|0.71|||<|0.115|2-Sided|95.0|0.47|1.09|||Regression, Cox|||Severe asthma exacerbation|
1610252|NCT02554786|2957884|Superiority||Hazard Ratio (HR)|0.44|||<|0.001|2-Sided|95.0|0.3|0.63|||Regression, Cox|||Severe asthma exacerbation|
1610253|NCT02554786|2957884|Superiority||Hazard Ratio (HR)|0.54|||<|0.003|2-Sided|95.0|0.36|0.81|||Regression, Cox|||Severe asthma exacerbation|
1610254|NCT02554786|2957884|Superiority||Hazard Ratio (HR)|0.81|||<|0.209|2-Sided|95.0|0.59|1.12|||Regression, Cox|||Moderate or severe asthma exacerbation|
1610255|NCT02554786|2957884|Superiority||Hazard Ratio (HR)|0.45|||<|0.001|2-Sided|95.0|0.34|0.6|||Regression, Cox|||Moderate or severe asthma exacerbation|
1610256|NCT02554786|2957884|Superiority||Hazard Ratio (HR)|0.53|||<|0.001|2-Sided|95.0|0.39|0.72|||Regression, Cox|||Moderate or severe asthma exacerbation|
1610257|NCT02554786|2957885|Superiority||LS Mean|-0.09|Standard Error of the Mean|0.081||0.245|2-Sided|95.0|-0.25|0.06|||LMM|||Week 1-52 Mean daily number of puffs|
1610258|NCT02554786|2957885|Superiority||LS Mean|-0.23|Standard Error of the Mean|0.081||0.004|2-Sided|95.0|-0.39|-0.07|||LMM|||Week 1-52 Mean daily number of puffs|
1610259|NCT02554786|2957885|Superiority||LS Mean|-0.28|Standard Error of the Mean|0.081|<|0.001|2-Sided|95.0|-0.44|-0.12|||LMM|||Week 1-52 Mean daily number of puffs|
1610260|NCT02554786|2957885|Superiority||LS Mean|-0.04|Standard Error of the Mean|0.048|<|0.384|2-Sided|95.0|-0.14|0.05|||LMM|||Week 1-52 Mean daytime number of puffs|
1610261|NCT02554786|2957885|Superiority||LS Mean|-0.15|Standard Error of the Mean|0.048|<|0.002|2-Sided|95.0|-0.24|-0.05|||LMM|||Week 1-52 Mean daytime number of puffs|
1610262|NCT02554786|2957885|Superiority||LS Mean|-0.17|Standard Error of the Mean|0.048|<|0.001|2-Sided|95.0|-0.26|-0.07|||LMM|||Week 1-52 Mean daytime number of puffs|
1610263|NCT02554786|2957885|Superiority||LS Mean|-0.05|Standard Error of the Mean|0.039|<|0.226|2-Sided|95.0|-0.12|0.03|||LMM|||Week 1-52 Mean night-time number of puffs|
1610264|NCT02554786|2957885|Superiority||LS Mean|-0.09|Standard Error of the Mean|0.039|<|0.019|2-Sided|95.0|-0.17|-0.02|||LMM|||Week 1-52 Mean night-time number of puffs|
1610265|NCT02554786|2957885|Superiority||LS Mean|-0.11|Standard Error of the Mean|0.039|<|0.004|2-Sided|95.0|-0.19|-0.04|||LMM|||Week 1-52 Mean night-time number of puffs|
1610266|NCT02554786|2957885|Superiority||LS Mean|-0.09|Standard Error of the Mean|0.081|<|0.29|2-Sided|95.0|-0.24|-0.07|||LMM|||Week 1-26 Mean daily number of puffs|
1610267|NCT02554786|2957885|Superiority||LS Mean|-0.19|Standard Error of the Mean|0.081|<|0.017|2-Sided|95.0|-0.35|-0.03|||LMM|||Week 1-26 Mean daily number of puffs|
1610268|NCT02554786|2957885|Superiority||LS Mean|-0.31|Standard Error of the Mean|0.081|<|0.001|2-Sided|95.0|-0.46|-0.15|||LMM|||Week 1-26 Mean daily number of puffs|
1610269|NCT02554786|2957885|Superiority||LS Mean|-0.04|Standard Deviation|0.047|<|0.425|2-Sided|95.0|-0.13|0.06|||LMM|||Week 1-26 Mean daytime number of puffs|
1610270|NCT02554786|2957885|Superiority||LS Mean|-0.12|Standard Error of the Mean|0.047|<|0.011|2-Sided|95.0|-0.21|-0.03|||LMM|||Week 1-26 Mean daytime number of puffs|
1610271|NCT02554786|2957885|Superiority||LS Mean|-0.19|Standard Error of the Mean|0.047|<|0.001|2-Sided|95.0|-0.28|-0.09|||LMM|||Week 1-26 Mean daytime number of puffs|
1610272|NCT02554786|2957885|Superiority||LS Mean|-0.04|Standard Error of the Mean|0.039|<|0.261|2-Sided|95.0|-0.12|0.03|||LMM|||Week 1-26 Mean night-time number of puffs|
1610273|NCT02554786|2957885|Superiority||LS Mean|-0.08|Standard Error of the Mean|0.039|<|0.035|2-Sided|95.0|-0.16|-0.01|||LMM|||Week 1-26 Mean night-time number of puffs|
1610274|NCT02554786|2957885|Superiority||LS Mean|-0.13|Standard Error of the Mean|0.039|<|0.001|2-Sided|95.0|-0.2|-0.05|||LMM|||Week1-26 Mean night-time number of puffs|
1610275|NCT02554786|2957886|Superiority||LS Mean|4.8|Standard Error of the Mean|2.2||0.029|2-Sided|95.0|0.5|9.1|||LMM||||
1610276|NCT02554786|2957886|Superiority||LS Mean|8.9|Standard Error of the Mean|2.19|<|0.001|2-Sided|95.0|4.6|13.2|||LMM||||
1610277|NCT02554786|2957886|Superiority||LS Mean|6.4|Standard Error of the Mean|2.19|<|0.003|2-Sided|95.0|2.1|10.7|||LMM||||
1610278|NCT02554786|2957887|Superiority||LS Mean|0.9|Standard Error of the Mean|1.73||0.588|2-Sided|95.0|-2.5|4.3|||LMM||||
1610279|NCT02554786|2957887|Superiority||LS Mean|3.9|Standard Error of the Mean|1.72||0.024|2-Sided|95.0|0.5|7.3|||LMM||||
1610280|NCT02554786|2957887|Superiority||LS Mean|2.8|Standard Error of the Mean|1.72||0.104|2-Sided|95.0|-0.6|6.2|||LMM||||
1610281|NCT02554786|2957888|Superiority||LS Mean|3.2|Standard Error of the Mean|2.25||0.151|2-Sided|95.0|-1.2|7.7|||LMM||||
1610282|NCT02554786|2957888|Superiority||LS Mean|8.1|Standard Error of the Mean|2.25|<|0.001|2-Sided|95.0|3.7|12.5|||LMM||||
1610283|NCT02554786|2957888|Superiority||LS Mean|5.0|Standard Error of the Mean|2.25|<|0.026|2-Sided|95.0|0.6|9.4|||LMM||||
1610284|NCT02554786|2957889|Superiority||LS Mean|3.4|Standard Error of the Mean|2.29||0.135|2-Sided|95.0|-1.1|7.9|||LMM||||
1610285|NCT02554786|2957889|Superiority||LS Mean|9.1|Standard Error of the Mean|2.29|<|0.001|2-Sided|95.0|4.6|13.6|||LMM||||
1610286|NCT02554786|2957889|Superiority||LS Mean|5.8|Standard Error of the Mean|2.29|<|0.012|2-Sided|95.0|1.3|10.2|||Linear Mixed Model (LMM)||||
1610287|NCT02554786|2957890|Superiority||Odds Ratio (OR)|1.05||||0.771|2-Sided|95.0|0.75|1.49|||Logistic regression model|||Day 364|
1610288|NCT02554786|2957890|Superiority||Odds Ratio (OR)|2.24|||<|0.001|2-Sided|95.0|1.58|3.17|||Logistic regression model|||Day 364|
1610289|NCT02554786|2957890|Superiority||Odds Ratio (OR)|1.34|||<|0.088|2-Sided|95.0|0.96|1.87|||Logistic regression model|||Day 364|
1610290|NCT02554786|2957890|Superiority||Odds Ratio (OR)|1.06|||<|0.746|2-Sided|95.0|0.76|1.46|||Logistic regression model|||Day 183|
1610291|NCT02554786|2957890|Superiority||Odds Ratio (OR)|1.73|||<|0.001|2-Sided|95.0|1.26|2.37|||Logistic regression model|||Day 183|
1610292|NCT02554786|2957890|Superiority||Odds Ratio (OR)|1.31|||<|0.094|2-Sided|95.0|0.95|1.81|||Logistic regression model|||Day 183|
1610435|NCT02553746|2957976|Superiority|||||||0.171|||||||Wilcoxon (Mann-Whitney)||||
1610293|NCT02554786|2957891|Superiority||LS Mean|9.1|Standard Error of the Mean|2.95||0.002|2-Sided|95.0|3.3|14.9|||LMM|||Week 52: Mean evening PEF|
1610294|NCT02554786|2957891|Superiority||LS Mean|29.1|Standard Error of the Mean|2.94|<|0.001|2-Sided|95.0|23.3|34.8|||LMM|||Week 52: Mean evening PEF|
1610295|NCT02554786|2957891|Superiority||LS Mean|23.7|Standard Error of the Mean|2.94|<|0.001|2-Sided|95.0|18.0|29.5|||LMM|||Week 52: Mean evening PEF|
1610296|NCT02554786|2957891|Superiority||LS Mean|13.8|Standard Error of the Mean|3.08|<|0.001|2-Sided|95.0|7.7|19.8|||LMM|||Week 52: Mean morning PEF|
1610297|NCT02554786|2957891|Superiority||LS Mean|30.2|Standard Error of the Mean|3.07|<|0.001|2-Sided|95.0|24.2|36.3|||LMM|||Week 52: Mean morning PEF|
1610298|NCT02554786|2957891|Superiority||LS Mean|28.7|Standard Error of the Mean|3.07|<|0.001|2-Sided|95.0|22.7|34.8|||LMM|||Week 52: Mean morning PEF|
1610299|NCT02554786|2957891|Superiority||LS Mean|8.6|Standard Error of the Mean|2.83|<|0.002|2-Sided|95.0|3.1|14.2|||LMM|||Week 26: Mean evening PEF|
1610300|NCT02554786|2957891|Superiority||LS Mean|30.4|Standard Error of the Mean|2.83|<|0.001|2-Sided|95.0|24.8|35.9|||LMM|||Week 26: Mean evening PEF|
1610301|NCT02554786|2957891|Superiority||LS Mean|24.8|Standard Error of the Mean|2.82|<|0.001|2-Sided|95.0|19.3|30.3|||LMM|||Week 26: Mean evening PEF|
1610302|NCT02554786|2957891|Superiority||LS Mean|13.3|Standard Error of the Mean|2.97|<|0.001|2-Sided|95.0|7.5|19.1|||LMM|||Week 26: Mean morning PEF|
1610303|NCT02554786|2957891|Superiority||LS Mean|32.2|Standard Error of the Mean|2.97|<|0.001|2-Sided|95.0|26.4|38.1|||LMM|||Week 26: Mean morning PEF|
1610304|NCT02554786|2957891|Superiority||LS Mean|29.6|Standard Error of the Mean|2.96|<|0.001|2-Sided|95.0|23.8|35.4|||Linear Mixed Model (LMM)|||Week 26: Mean morning PEF|
1610305|NCT02554786|2957892|Superiority||LS Mean|0.053|Standard Error of the Mean|0.0356||0.139|2-Sided|95.0|-0.017|0.122|||MMRM|||Day 365|
1610306|NCT02554786|2957892|Superiority||LS Mean|0.246|Standard Error of the Mean|0.0357|<|0.001|2-Sided|95.0|0.176|0.316|||MMRM|||Day 365|
1610307|NCT02554786|2957892|Superiority||LS Mean|0.215|Standard Error of the Mean|0.0358|<|0.001|2-Sided|95.0|0.145|0.285|||MMRM|||Day 365|
1610308|NCT02554786|2957892|Superiority||LS Mean|0.083|Standard Error of the Mean|0.0343|<|0.015|2-Sided|95.0|0.016|0.151|||MMRM|||Day 184|
1610309|NCT02554786|2957892|Superiority||LS Mean|0.265|Standard Error of the Mean|0.0346|<|0.001|2-Sided|95.0|0.197|0.333|||MMRM|||Day 184|
1610310|NCT02554786|2957892|Superiority||LS Mean|0.228|Standard Error of the Mean|0.0345|<|0.001|2-Sided|95.0|0.161|0.296|||MMRM|||Day 184|
1610311|NCT02554786|2957892|Superiority||LS Mean|-0.018|Standard Error of the Mean|0.0252|<|0.475|2-Sided|95.0|-0.067|0.031|||MMRM|||Day 2|
1610312|NCT02554786|2957892|Superiority||LS Mean|0.21|Standard Error of the Mean|0.025|<|0.001|2-Sided|95.0|0.161|0.259|||MMRM|||Day 2|
1610313|NCT02554786|2957892|Superiority||LS Mean|0.189|Standard Error of the Mean|0.0253|<|0.001|2-Sided|95.0|0.139|0.238|||MMRM|||Day 2|
1610314|NCT02554786|2957893|Superiority||LS Mean|0.036|Standard Error of the Mean|0.0248||0.143|2-Sided|95.0|-0.012|0.085|||MMRM|||Day 365|
1610315|NCT02554786|2957893|Superiority||LS Mean|0.146|Standard Error of the Mean|0.0248|<|0.001|2-Sided|95.0|0.098|0.195|||MMRM|||Day 365|
1610316|NCT02554786|2957893|Superiority||LS Mean|0.076|Standard Error of the Mean|0.0249|<|0.002|2-Sided|95.0|0.027|0.125|||MMRM|||Day 365|
1610317|NCT02554786|2957893|Superiority||LS Mean|0.017|Standard Error of the Mean|0.0244|<|0.49|2-Sided|95.0|-0.031|0.065|||MMRM|||Day 184|
1610318|NCT02554786|2957893|Superiority||LS Mean|0.141|Standard Error of the Mean|0.0246|<|0.001|2-Sided|95.0|0.093|0.19|||MMRM|||Day 184|
1610319|NCT02554786|2957893|Superiority||LS Mean|0.05|Standard Error of the Mean|0.0246|<|0.044|2-Sided|95.0|0.001|0.098|||MMRM|||Day 184|
1610320|NCT02554786|2957893|Superiority||LS Mean|-0.002|Standard Error of the Mean|0.0237|<|0.927|2-Sided|95.0|-0.049|0.044|||MMRM|||Day 2|
1610321|NCT02554786|2957893|Superiority||LS Mean|0.139|Standard Error of the Mean|0.0235|<|0.001|2-Sided|95.0|0.093|0.185|||MMRM|||Day 2|
1610322|NCT02554786|2957893|Superiority||LS Mean|0.086|Standard Error of the Mean|0.0237|<|0.001|2-Sided|95.0|0.04|0.133|||MMRM|||Day 2|
1610323|NCT02554786|2957894|Superiority||LS Mean|0.031|Standard Error of the Mean|0.0231||0.182|2-Sided|95.0|-0.014|0.076|||MMRM|||Day 364: 1 hour|
1610324|NCT02554786|2957894|Superiority||LS Mean|0.262|Standard Error of the Mean|0.0232|<|0.001|2-Sided|95.0|0.216|0.308|||MMRM|||Day 364: 1 hour|
1610325|NCT02554786|2957894|Superiority||LS Mean|0.163|Standard Error of the Mean|0.0234|<|0.001|2-Sided|95.0|0.117|0.209|||MMRM|||Day 364: 1 hour|
1610326|NCT02554786|2957894|Superiority||LS Mean|0.032|Standard Error of the Mean|0.0226|<|0.162|2-Sided|95.0|-0.013|0.076|||MMRM|||Day 364: 30 minutes|
1610327|NCT02554786|2957894|Superiority||LS Mean|0.264|Standard Error of the Mean|0.0227|<|0.001|2-Sided|95.0|0.219|0.308|||MMRM|||Day 364: 30 minutes|
1610328|NCT02554786|2957894|Superiority||LS Mean|0.155|Standard Error of the Mean|0.0228|<|0.001|2-Sided|95.0|0.11|0.2|||MMRM|||Day 364: 30 minutes|
1610329|NCT02554786|2957894|Superiority||LS Mean|0.026|Standard Error of the Mean|0.0227|<|0.244|2-Sided|95.0|-0.018|0.071|||MMRM|||Day 364: 5 minutes|
1610330|NCT02554786|2957894|Superiority||LS Mean|0.249|Standard Error of the Mean|0.0228|<|0.001|2-Sided|95.0|0.205|0.294|||MMRM|||Day 364: 5 minutes|
1610331|NCT02554786|2957894|Superiority||LS Mean|0.139|Standard Error of the Mean|0.0229|<|0.001|2-Sided|95.0|0.094|0.184|||MMRM|||Day 364: 5 minutes|
1610332|NCT02554786|2957894|Superiority||LS Mean|0.039|Standard Error of the Mean|0.0218|<|0.071|2-Sided|95.0|-0.003|0.082|||MMRM|||Day 183: 1 hour|
1610333|NCT02554786|2957894|Superiority||LS Mean|0.259|Standard Error of the Mean|0.0222|<|0.001|2-Sided|95.0|0.215|0.302|||MMRM|||Day 183: 1 hour|
1610334|NCT02554786|2957894|Superiority||LS Mean|0.18|Standard Error of the Mean|0.0219|<|0.001|2-Sided|95.0|0.137|0.223|||MMRM|||Day 183: 1 hour|
1610335|NCT02554786|2957894|Superiority||LS Mean|0.04|Standard Error of the Mean|0.0221|<|0.071|2-Sided|95.0|-0.003|0.083|||MMRM|||Day 183: 30 minutes|
1610336|NCT02554786|2957894|Superiority||LS Mean|0.259|Standard Error of the Mean|0.0224|<|0.001|2-Sided|95.0|0.215|0.303|||MMRM|||Day 183: 30 minutes|
1610337|NCT02554786|2957894|Superiority||LS Mean|0.176|Standard Error of the Mean|0.0222|<|0.001|2-Sided|95.0|0.133|0.22|||MMRM|||Day 183: 30 minutes|
1610338|NCT02554786|2957894|Superiority||LS Mean|0.044|Standard Error of the Mean|0.0216|<|0.041|2-Sided|95.0|0.002|0.087|||MMRM|||Day 183: 5 minutes|
1610339|NCT02554786|2957894|Superiority||LS Mean|0.243|Standard Error of the Mean|0.0219|<|0.001|2-Sided|95.0|0.2|0.286|||MMRM|||Day 183: 5 minutes|
1610340|NCT02554786|2957894|Superiority||LS Mean|0.163|Standard Error of the Mean|0.0217|<|0.001|2-Sided|95.0|0.121|0.206|||MMRM|||Day 183: 5 minutes|
1610341|NCT02554786|2957894|Superiority||LS Mean|0.043|Standard Error of the Mean|0.0205|<|0.037|2-Sided|95.0|0.003|0.083|||MMRM|||Day 86: 1hour|
1610342|NCT02554786|2957894|Superiority||LS Mean|0.249|Standard Error of the Mean|0.0208|<|0.001|2-Sided|95.0|0.208|0.289|||MMRM|||Day 86: 1 hour|
1610343|NCT02554786|2957894|Superiority||LS Mean|0.187|Standard Error of the Mean|0.0205|<|0.001|2-Sided|95.0|0.147|0.227|||MMRM|||Day 86: 1 hour|
1610344|NCT02554786|2957894|Superiority||LS Mean|0.038|Standard Error of the Mean|0.0202|<|0.057|2-Sided|95.0|-0.001|0.078|||MMRM|||Day 86: 30 minutes|
1610345|NCT02554786|2957894|Superiority||LS Mean|0.252|Standard Error of the Mean|0.0205|<|0.001|2-Sided|95.0|0.211|0.292|||MMRM|||Day 86: 30 minutes|
1610346|NCT02554786|2957894|Superiority||LS Mean|0.18|Standard Error of the Mean|0.0203|<|0.001|2-Sided|95.0|0.14|0.219|||MMRM|||Day 86: 30 minutes|
1610347|NCT02554786|2957894|Superiority||LS Mean|0.055|Standard Error of the Mean|0.0203|<|0.007|2-Sided|95.0|0.015|0.095|||MMRM|||Day 86: 5minutes|
1610348|NCT02554786|2957894|Superiority||LS Mean|0.231|Standard Error of the Mean|0.0206|<|0.001|2-Sided|95.0|0.191|0.271|||MMRM|||Day 86: 5 minutes|
1610349|NCT02554786|2957894|Superiority||LS Mean|0.163|Standard Error of the Mean|0.0204|<|0.001|2-Sided|95.0|0.123|0.203|||MMRM|||Day 86: 5 minutes|
1610350|NCT02554786|2957894|Superiority||LS Mean|0.037|Standard Error of the Mean|0.0194|<|0.059|2-Sided|95.0|-0.001|0.075|||MMRM|||Day 30: 1 hour|
1610351|NCT02554786|2957894|Superiority||LS Mean|0.258|Standard Error of the Mean|0.0198|<|0.001|2-Sided|95.0|0.219|0.296|||MMRM|||Day 30: 1 hour|
1610352|NCT02554786|2957894|Superiority||LS Mean|0.19|Standard Error of the Mean|0.0196|<|0.001|2-Sided|95.0|0.152|0.229|||MMRM|||Day 30: 1 hour|
1610353|NCT02554786|2957894|Superiority||LS Mean|0.043|Standard Error of the Mean|0.0192|<|0.026|2-Sided|95.0|0.005|0.08|||MMRM|||Day 30: 30 minutes|
1610354|NCT02554786|2957894|Superiority||LS Mean|0.253|Standard Error of the Mean|0.0196|<|0.001|2-Sided|95.0|0.214|0.291|||MMRM|||Day 30: 30 minutes|
1610355|NCT02554786|2957894|Superiority||LS Mean|0.194|Standard Error of the Mean|0.0194|<|0.001|2-Sided|95.0|0.156|0.232|||MMRM|||Day 30: 30 minutes|
1610356|NCT02554786|2957894|Superiority||LS Mean|0.053|Standard Error of the Mean|0.0191|<|0.005|2-Sided|95.0|0.016|0.091|||MMRM|||Day 30: 5 minutes|
1610357|NCT02554786|2957894|Superiority||LS Mean|0.232|Standard Error of the Mean|0.0194|<|0.001|2-Sided|95.0|0.194|0.27|||MMRM|||Day 30: 5 minutes|
1610358|NCT02554786|2957894|Superiority||LS Mean|0.189|Standard Error of the Mean|0.0192|<|0.001|2-Sided|95.0|0.151|0.226|||MMRM|||Day 30: 5 minutes|
1610359|NCT02554786|2957894|Superiority||LS Mean|0.007|Standard Error of the Mean|0.0139|<|0.632|2-Sided|95.0|-0.021|0.034|||MMRM|||Day 1: 1hour|
1610360|NCT02554786|2957894|Superiority||LS Mean|0.205|Standard Error of the Mean|0.0139|<|0.001|2-Sided|95.0|0.177|0.232|||MMRM|||Day 1: 1hour|
1610361|NCT02554786|2957894|Superiority||LS Mean|0.178|Standard Error of the Mean|0.0139|<|0.001|2-Sided|95.0|0.15|0.205|||MMRM|||Day 1: 1 hour|
1610362|NCT02554786|2957894|Superiority||LS Mean|0.027|Standard Error of the Mean|0.0132|<|0.038|2-Sided|95.0|0.001|0.053|||MMRM|||Day 1: 30 minutes|
1610363|NCT02554786|2957894|Superiority||LS Mean|0.185|Standard Error of the Mean|0.0132|<|0.001|2-Sided|95.0|0.159|0.211|||MMRM|||Day 1: 30 minutes|
1610364|NCT02554786|2957894|Superiority||LS Mean|0.175|Standard Error of the Mean|0.0132|<|0.001|2-Sided|95.0|0.149|0.201|||MMRM|||Day 1: 30 minutes|
1610365|NCT02554786|2957894|Superiority||LS Mean|0.044|Standard Error of the Mean|0.0122|<|0.001|2-Sided|95.0|0.02|0.068|||MMRM|||Day1: 15 minutes|
1610366|NCT02554786|2957894|Superiority||LS mean|0.174|Standard Error of the Mean|0.0123|<|0.001|2-Sided|95.0|0.15|0.198|||MMRM|||Day 1: 15 minutes|
1610367|NCT02554786|2957894|Superiority||LS Mean|0.162|Standard Error of the Mean|0.0122|<|0.001|2-Sided|95.0|0.138|0.186|||MMRM|||Day 1: 15 minutes|
1610368|NCT02554786|2957894|Superiority||LS Mean|0.055|Standard Error of the Mean|0.0116|<|0.001|2-Sided|95.0|0.032|0.078|||MMRM|||Day 1: 5 minutes|
1610369|NCT02554786|2957894|Superiority||LS Mean|0.152|Standard Error of the Mean|0.0116|<|0.001|2-Sided|95.0|0.129|0.175|||MMRM|||Day 1: 5 minutes|
1610370|NCT02554786|2957894|Superiority||LS Mean|0.142|Standard Error of the Mean|0.0116|<|0.001|2-Sided|95.0|0.119|0.164|||MMRM|||Day 1: 5 minutes|
1610371|NCT02554786|2957895|Superiority||LS Mean|0.037|Standard Error of the Mean|0.02||0.063|2-Sided|95.0|-0.002|0.076|||MMRM|||Day 86|
1610372|NCT02554786|2957895|Superiority||LS Mean|0.184|Standard Error of the Mean|0.0202|<|0.001|2-Sided|95.0|0.144|0.224|||MMRM|||Day 86|
1610373|NCT02554786|2957895|Superiority||LS Mean|0.122|Standard Error of the Mean|0.0201|<|0.001|2-Sided|95.0|0.083|0.162|||MMRM|||Day 86|
1610374|NCT02554786|2957895|Superiority||LS Mean|0.035|Standard Error of the Mean|0.0192|<|0.064|2-Sided|95.0|-0.002|0.073|||MMRM|||Day 30|
1610375|NCT02554786|2957895|Superiority||LS Mean|0.196|Standard Error of the Mean|0.0194|<|0.001|2-Sided|95.0|0.158|0.234|||MMRM|||Day 30|
1610376|NCT02554786|2957895|Superiority||LS Mean|0.132|Standard Error of the Mean|0.0193|<|0.001|2-Sided|95.0|0.094|0.17|||MMRM|||Day 30|
1610377|NCT02554786|2957896|Superiority||LS Mean|0.048|Standard Error of the Mean|0.0234||0.04|2-Sided|95.0|0.002|0.094|||MMRM||||
1610378|NCT02554786|2957896|Superiority||LS Mean|0.209|Standard Error of the Mean|0.0235|<|0.001|2-Sided|95.0|0.163|0.255|||MMRM||||
1610379|NCT02554786|2957896|Superiority||LS Mean|0.136|Standard Error of the Mean|0.0235|<|0.001|2-Sided|95.0|0.09|0.183|||MMRM||||
1610380|NCT02554786|2957897|Superiority||LS Mean|-0.203|Standard Error of the Mean|0.0318|<|0.001|2-Sided|95.0|-0.266|-0.141|||MMRM|||Week 52: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 & 150/320 μg and MF 400 & 800 μg derived by weighting treatment groups equally.|
1610381|NCT02554786|2957897|Superiority||LS Mean|0.01|Standard Error of the Mean|0.0447|<|0.824|2-Sided|95.0|-0.078|0.098|||MMRM|||Week 52|
1610382|NCT02554786|2957897|Superiority||LS Mean|-0.266|Standard Error of the Mean|0.045|<|0.001|2-Sided|95.0|-0.354|-0.177|||MMRM|||Week 52|
1610383|NCT02554786|2957897|Superiority||LS Mean|-0.141|Standard Error of the Mean|0.0449|<|0.002|2-Sided|95.0|-0.229|-0.053|||MMRM|||Week 52|
1610384|NCT02554786|2957897|Superiority||LS Mean|-0.209|Standard Error of the Mean|0.031|<|0.001|2-Sided|95.0|-0.27|-0.149|||MMRM|||Week 26: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 & 150/320 μg and MF 400 & 800 μg derived by weighting treatment groups equally.|
1610385|NCT02554786|2957897|Superiority||LS Mean|-0.054|Standard Error of the Mean|0.0437|<|0.214|2-Sided|95.0|-0.14|0.031|||MMRM|||Week 26|
1610386|NCT02554786|2957897|Superiority||LS Mean|-0.248|Standard Error of the Mean|0.0439|<|0.001|2-Sided|95.0|-0.334|-0.162|||MMRM|||Week 26|
1610387|NCT02554786|2957897|Superiority||LS Mean|-0.171|Standard Error of the Mean|0.0437|<|0.001|2-Sided|95.0|-0.257|-0.086|||MMRM|||Week 26|
1610388|NCT02554786|2957897|Superiority||LS Mean|-0.188|Standard Error of the Mean|0.0307|<|0.001|2-Sided|95.0|-0.248|-0.128|||MMRM|||Week 12: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 & 150/320 μg and MF 400 & 800 μg derived by weighting treatment groups equally.|
1610389|NCT02554786|2957897|Superiority||LS Mean|-0.052|Standard Error of the Mean|0.0431|<|0.232|2-Sided|95.0|-0.136|0.033|||MMRM|||Week 12|
1610390|NCT02554786|2957897|Superiority||LS Mean|-0.248|Standard Error of the Mean|0.0435|<|0.001|2-Sided|95.0|-0.333|-0.162|||MMRM|||Week 12|
1610391|NCT02554786|2957897|Superiority||LS Mean|-0.129|Standard Error of the Mean|0.0431|<|0.003|2-Sided|95.0|-0.214|-0.044|||MMRM|||Week 12|
1610392|NCT02554786|2957897|Superiority||LS Mean|-0.184|Standard Error of the Mean|0.0294|<|0.001|2-Sided|95.0|-0.242|-0.127|||MMRM|||Week 4: The comparison of QMF149 vs. MF was based on combined effects of QMF149 150/160 & 150/320 μg and MF 400 & 800 μg derived by weighting treatment groups equally.|
1610393|NCT02554786|2957897|Superiority||LS Mean|-0.055|Standard Error of the Mean|0.0414|<|0.186|2-Sided|95.0|-0.136|0.026|||MMRM|||Week 4|
1610394|NCT02554786|2957897|Superiority||LS Mean|-0.196|Standard Error of the Mean|0.0416|<|0.001|2-Sided|95.0|-0.278|-0.115|||MMRM|||Week 4|
1610395|NCT02554786|2957897|Superiority||LS Mean|-0.172|Standard Error of the Mean|0.0415|<|0.001|2-Sided|95.0|-0.254|-0.091|||MMRM|||Week 4|
1610396|NCT02554786|2957898|Superiority||LS Mean|0.211|Standard Error of the Mean|0.0224|<|0.001|2-Sided|95.0|0.167|0.255|||MMRM||||
1610397|NCT02554786|2957898|Superiority||Least Square mean (LS Mean)|0.132|Standard Error of the Mean|0.0223|<|0.001|2-Sided|95.0|0.088|0.176|||Mixed Model for Repeated Measures (MMRM)||||
1610398|NCT02554682|2957899|Superiority|||||||0.006|||||||t-test, 2 sided||||
1610399|NCT02554682|2957900|Superiority|||||||0.165|||||||t-test, 2 sided||||
1610400|NCT02554682|2957901|Superiority|||||||0.112|||||||t-test, 2 sided||||
1610401|NCT02554682|2957902|Superiority|||||||0.159|||||||t-test, 2 sided||||
1610402|NCT02554682|2957903|Superiority|||||||0.001|||||||t-test, 2 sided||||
1610403|NCT02554682|2957904|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1610404|NCT02554682|2957905|Superiority|||||||0.008|||||||t-test, 2 sided||||
1610405|NCT02554682|2957906|Superiority|||||||0.394|||||||t-test, 2 sided||||
1610406|NCT02554682|2957907|Superiority|||||||0.571|||||||t-test, 2 sided||||
1610407|NCT02554682|2957908|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1610408|NCT02554682|2957909|Superiority|||||||0.003|||||||t-test, 2 sided||||
1610409|NCT02554682|2957910|Superiority|||||||0.037|||||||t-test, 2 sided||||
1610410|NCT02554682|2957911|Superiority|||||||0.029|||||||Generalized Linear Model||||
1610411|NCT02554682|2957911|Superiority|||||||0.134|||||||Generalized Linear Model||||
1610412|NCT02554682|2957911|Superiority|||||||0.176|||||||Generalized Linear Model||||
1610413|NCT02554682|2957911|Superiority|||||||0.505|||||||Generalized Linear Model||||
1610414|NCT02554682|2957912|Superiority|||||||0.21|||||||Generalized Linear Model||||
1610415|NCT02554682|2957912|Superiority|||||||0.952|||||||Generalized Linear Model||||
1610416|NCT02554682|2957912|Superiority|||||||0.02|||||||Generalized Linear Model||||
1610417|NCT02554682|2957912|Superiority|||||||0.677|||||||Generalized Linear Model||||
1610418|NCT02554682|2957913|Other|||||||0.082|||||||Generalized Linear Model||||
1610419|NCT02554682|2957913|Superiority|||||||0.886|||||||Generalized Linear Model||||
1610420|NCT02554682|2957913|Superiority|||||||0.796|||||||Generalized Linear Model||||
1610421|NCT02554682|2957913|Superiority|||||||0.906|||||||Generalized Linear Model||||
1610422|NCT02554279|2957941|Other||Absolute difference|-9.5|||||2-Sided|95.0|-19.2|0.2|||||||
1610423|NCT02554279|2957942|Other||Absolute difference|3.8|||||2-Sided|95.0|-3.8|11.3|||||||
1610424|NCT02554279|2957943|Other||Absolute difference|1.2|||||2-Sided|95.0|-6.6|8.9|||||||
1610425|NCT02554279|2957944|Non-Inferiority|The study had at least 80% power, to demonstrate the non-inferiority of menotropin to recombinant FSH at 1-sided significance level of 0.025 with a -12% non-inferiority margin.|Absolute difference|4.7|||||2-Sided|95.0|-2.7|12.1||||||Null hypothesis was defined as the difference between ongoing pregnancy rate of participants randomized and treated with menotropin and recombinant FSH, as ≤-12%.|
1610426|NCT02553928|2957950|Other||Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.19||0.097|2-Sided|95.0|-0.06|0.69||Based on full analysis set|ANCOVA||The comparison is to BID memantine.|The ADCS-CGIC was analyzed based on an analysis of covariance (ANCOVA) of ADCS-CGIC score at Week 12, with treatment and site as fixed factors, and baseline score as a covariate using observed cases.|
1610427|NCT02553915|2957953|Other|Exploratory|||||<|0.1|||||||Spearman Rank Order Correlation|||To evaluate whether EPA treatment produces decreases in the expression of inflammation pathway-related genes. [Time Frame: 12 weeks] (We evaluated gene expression of IL-6 and TNF-α.)|
1610428|NCT02553915|2957954|Other|Exploratory.|||||<|0.1|||||||Spearman Rank Order Correlation|||To evaluate whether EPA treatment produces decreases in mitogen-stimulated PBMC IL-6. [Time Frame: 12 weeks] Comparisons were made between pre and post treatment levels in each of the 4 treatment arms.|
1610429|NCT02553915|2957955|Other||||||<|0.01|||||||Kruskal-Wallis|||Change in IDS-C30 scores were compared pre and post 12 weeks of treatment with each intervention, within each arm.|
1610430|NCT02553915|2957956|Superiority||||||<|0.1|||||||ANOVA|||"To evaluate:~whether EPA treatment produces a decrease in ratings of depression severity, when compared with placebo-treated subjects; and~whether the changes in IL-6 or mitogen- stimulated PBMC TNF-α expression mediate changes observed in ratings of depression.~[Time Frame: 12 weeks]"|
1610431|NCT02553915|2957957|Other|Comparisons were made for each biomarker within each arm pre and post 12 weeks of treatment.|||||<|0.1|||||||Kruskal-Wallis|||To evaluate whether a dose-response relationship exists between dose of EPA and decrease either in plasma IL-6 levels or in mitogen-stimulated PBMC TNF-α expression and secretion, when compared with placebo. [Time Frame: 12 weeks]. Comparisons were made within each arm pre and post 12 weeks of treatment.|
1610432|NCT02553746|2957973|Superiority||||||<|0.005|||||||Wilcoxon (Mann-Whitney)||||
1610433|NCT02553746|2957974|Superiority|||||||0.104|||||||Chi-squared, Corrected||||
1610446|NCT02553538|2957987|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1610447|NCT02553317|2958007|Superiority||||||=|0||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A CMH test was conducted with adjustment for GCS category (stratification factor used in randomization).|
1610448|NCT02553317|2958008|Superiority||||||=|0||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A CMH test was conducted with adjustment for GCS category (stratification factor used in randomization).|
1610449|NCT02553317|2958009|Superiority||||||<|0.0001||||||The resulting p-value was compared with a significance level of 5%.|Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was conducted with adjustment for GCS category (stratification factor used in randomization).|
1610450|NCT02553317|2958010|Superiority||Hazard Ratio (HR)|1.55|||||2-Sided|95.0|1.095|2.195|||||The HR was estimated from a Cox proportional Hazards regression model.|Time to platelet count response was analyzed using a Cox proportional hazards regression model with time to platelet count response as dependent variable, and treatment group and GCS category as independent variables. The hazard (or platelet count normalization rate) ratio from the Cox model was reported along with 95% CI.|
1610451|NCT02553317|2958010|Superiority||||||=|0||||||The resulting p-value was compared with a significance level of 5%.|Log Rank|||Time to platelet count response in the caplacizumab arm and placebo arm was compared by conducting a two-sided stratified log-rank test based on a KM analysis, with severity of neurological involvement (according to the Glasgow coma scale [GCS] category, stratification factor used in randomization: ≤12 / 13-15) as stratification factor.|
1610452|NCT02552966|2958015|Other||||||<|0.01|||||||t-test, 2 sided||||
1610453|NCT02552966|2958016|Other||||||<|0.01|||||||t-test, 2 sided||||
1610454|NCT02552966|2958017|Other||||||<|0.01|||||||t-test, 2 sided||||
1610455|NCT02552966|2958018|Other|||||||0.61|||||||t-test, 2 sided|This t-test was applied to determine if the mean salivary pepsin concentration changed between baseline and 2 week post UESAD measurements.|||
1610456|NCT02552810|2958024|Non-Inferiority or Equivalence|Sample size calculation, 30 (effect size: 0.5, alpha error: 0.05, power: 0.80).|||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1610457|NCT02552368|2958025|Superiority|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Signed-Rank Test for Satisfaction COPM between Baseline and 12 weeks|
1610458|NCT02552368|2958025|Superiority|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Signed-Rank Test for Performance COPM between Baseline and 12 weeks|
1610459|NCT02552368|2958026|Superiority|||||||0.002|||||||Paired t-Test||||
1610460|NCT02552147|2958038|Superiority|||||||0.69|||||||Binomial test||||
1610461|NCT02552147|2958039|Superiority|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Two-tailed|||
1610462|NCT02552147|2958040|Superiority|||||||1||||||P value was calculated to >0.99 and thus rounded to 1.0.|Wilcoxon (Mann-Whitney)|Two-tailed|||
1610463|NCT02552147|2958041|Superiority|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Two-tailed|||
1610464|NCT02552147|2958042|Superiority|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Two-tailed|||
1610465|NCT02552147|2958043|Superiority|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Two-tailed|||
1610466|NCT02552147|2958047|Superiority|||||||0.38|||||||Wilcoxon (Mann-Whitney)|Two-tailed|||
1610467|NCT02552147|2958048|Superiority|||||||0.44|||||||Wilcoxon (Mann-Whitney)|Two-tailed|||
1610468|NCT02551874|2958113|Non-Inferiority|Noninferiority was defined by upper bound of 95% CI <12 mg/dL.|Mean Difference (Final Values)|-19.99|Standard Error of the Mean|3.55|<|0.0001|2-Sided|95.0|-26.98|-13.0|||Mixed Models Analysis|Adjusted for treatment, baseline measurement, randomization stratification factor, visit, treatment-by-visit, and baseline-by-visit.|||
1610469|NCT02551874|2958114|Non-Inferiority|Noninferiority was defined by lower bound of 95% CI >-10%.|Adjusted Percent Difference|-0.4|||||2-Sided|95.0|-7.42|6.54|||||||
1610470|NCT02551874|2958115|Superiority||Odds Ratio (OR)|1.8||||0.008|2-Sided|95.0|1.16|2.67|||Regression, Logistic||||
1610471|NCT02551874|2958116|Superiority||Odds Ratio (OR)|0.4|||<|0.001|2-Sided|95.0|0.3|0.62|||Regression, Logistic|Adjusted for baseline HbA1c and randomization stratification factor (background medication of metformin with or without SU).|||
1610472|NCT02551874|2958117|Superiority||Mean Difference (Final Values)|-3.64|Standard Error of the Mean|0.282|<|0.001|2-Sided|95.0|-4.2|-3.09|||Mixed Models Analysis|Adjusted for treatment, baseline body weight, randomization stratification factor, visit, treatment-by-visit, and baseline body weight-by-visit.|||
1610473|NCT02551874|2958118|Non-Inferiority|Noninferiority was defined by upper bound of 95% CI <0.3%|Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.085||0.118|2-Sided|95.0|-0.3|0.03||Superiority|Mixed Models Analysis|Adjusted for treatment, baseline HbA1c, randomization stratification factor, visit, treatment-by-visit, and baseline HbA1c-by-visit.|||
1610474|NCT02551692|2958145|Other||Partial sum of squares|101.69||||0.318|2-Sided||||||ANCOVA||||
1610475|NCT02551692|2958146|Other||Partial sum of squares|29602.69||||0.26|2-Sided||||||ANOVA||||
1610476|NCT02551692|2958147|Other||Partial sum of squares|855.65||||0.534|2-Sided||||||ANOVA||||
1610477|NCT02551653|2958148|Other||Mean Ratio|1.047|||||2-Sided|95.0|0.786|1.34|||||||Mean Standardized Uptake Values - Lung: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.
1610478|NCT02551653|2958148|Other||Mean Ratio|1.056|||||2-Sided|95.0|0.853|1.269|||||||Mean Standardized Uptake Values - Heart, Right Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.
1610479|NCT02551653|2958148|Other||Mean Ratio|1.013|||||2-Sided|95.0|0.846|1.189|||||||Mean Standardized Uptake Values - Heart, Left Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.
1610554|NCT02549040|2958342|Other||Geometric mean ratio|0.88|||||2-Sided|90.0|0.79|0.97||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610480|NCT02551653|2958149|Other||Mean Ratio|0.958|||||2-Sided|95.0|0.692|1.241|||||||Volume of Distribution - Lung: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.
1610481|NCT02551653|2958149|Other||Mean Ratio|1.472|||||2-Sided|95.0|1.113|1.891|||||||Volume of Distribution - Heart, Right Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.
1610482|NCT02551653|2958149|Other||Mean Ratio|0.832|||||2-Sided|95.0|0.682|0.979|||||||Volume of Distribution - Heart, Left Ventricular Wall: The mean ratio was calculated using the posterior distribution of the ratio of group means (PAH subjects to Healthy Volunteers). The 95% confidence interval is a 95% Bayesian credible interval based on the highest posterior density interval.
1610483|NCT02551224|2958155|Superiority or Other||Mean Difference (Net)|0.41|||<|0.0001|2-Sided|95.0|0.21|0.61|||Wilcoxon (Mann-Whitney)||||
1610484|NCT02551224|2958156|Superiority or Other||Mean Difference (Net)|0.75|||<|0.0001|2-Sided|95.0|0.51|0.99|||Wilcoxon (Mann-Whitney)||||
1610485|NCT02550873|2958171|Superiority||Mean Difference (Net)|114.6|Standard Deviation|56.1||0.0416|2-Sided|90.0|22.2|207.1||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.|||
1610486|NCT02550873|2958181|Superiority||Mean Difference (Net)|-0.4|Standard Error of the Mean|1.31||0.7424|2-Sided|90.0|-2.6|1.7||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.|||
1610487|NCT02550873|2958182|Superiority|||||||0.1846||||||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction|||
1610488|NCT02550873|2958183|Superiority|||||||0.6308||||||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction|||
1610489|NCT02550873|2958184|Superiority|||||||0.0508||||||P-Value for increase in FVC ≥ 100 mL. P-Value for increase in FVC ≥ 200 mL not reported. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction|||
1610490|NCT02550873|2958185|Superiority|||||||0.29||||||P-Value for increase in % predicted FVC ≥ 5%. P-Value for an increase in % predicted FVC ≥ 10% not reported. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction|||
1610491|NCT02550873|2958186|Superiority|||||||0.5976||||||P-Value for decline in FVC ≥ 200 mL. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction|||
1610492|NCT02550873|2958186|Superiority|||||||0.7773||||||P-Value for decline in FVC ≥ 100 mL. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction|||
1610493|NCT02550873|2958187|Superiority|||||||0.2184||||||P-Value for decline in % predicted FVC ≥ 10%. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction|||
1610494|NCT02550873|2958187|Superiority|||||||0.4179||||||P-Value for decline in % Predicted FVC ≥ 5%. This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction|||
1610495|NCT02550873|2958188|Other|Correlation analysis||||||0.0069|||||||Pearson's correlation|||This study was not powered to test hypotheses beyond the primary endpoint.|
1610496|NCT02550873|2958188|Other|Correlation analysis||||||0.0001||||||This study was not powered to test hypotheses beyond the primary endpoint.|Pearson's correlation||||
1610497|NCT02550873|2958189|Superiority||Mean Difference (Net)|-1.2|Standard Error of the Mean|1.91||0.52|2-Sided|90.0|-4.4|1.9||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction|||
1610498|NCT02550873|2958190|Superiority||Mean Difference (Net)|43.6|Standard Error of the Mean|102.28||0.6707|2-Sided|90.0|-126.3|213.5||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction|||
1610499|NCT02550873|2958191|Superiority||Mean Difference (Net)|1.1|Standard Error of the Mean|1.96||0.5835|2-Sided|90.0|-2.2|4.3||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction|||
1610500|NCT02550873|2958192|Superiority||Mean Difference (Net)|31.9|Standard Error of the Mean|46.33||0.4927|2-Sided|90.0|-45.0|108.8||This study was not powered to test hypotheses beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction|||
1610501|NCT02550873|2958193|Superiority||Mean Difference (Net)|93.5|Standard Error of the Mean|72.98||0.2032|2-Sided|90.0|-27.7|214.7||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.|||
1610502|NCT02550873|2958194|Superiority||Mean Difference (Net)|31.3|Standard Error of the Mean|8.42||0.0002|2-Sided|90.0|17.4|45.1||This study was not powered to test hypothesis beyond the primary endpoint.|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.|||
1610503|NCT02550873|2958195|Superiority||Mean Difference (Net)|2.3|Standard Error of the Mean|0.72||0.0014|2-Sided|90.0|1.1|3.5||a priori threshold for statistical significance = 0.10|Mixed Models Analysis|Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction||"The sample size calculation was based on the following assumptions:~Normal distribution Homogeneity of variance the same in both arms, and for both types of patients Randomization ratio PRM-151:placebo = 2:1 Expected value for patients on pirfenidone or nintedanib = -1.5 Expected value for patients on no other treatment = -3 Expected value for patients on PRM-151 ≥ 0.75 Standard deviation = 5 75% of patients on a stable dose of pirfenidone or nintedanib α=0.10 two-sided Power = 80%"|
1610504|NCT02550652|2958206|Superiority||Difference in Percentage of Participants|7.3||||0.3726|2-Sided|95.0|-10.0|24.6||Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).|Cochran-Mantel-Haenszel||||
1610505|NCT02550652|2958207|Superiority||Difference in Percentage of Participants|10.6||||0.1838|2-Sided|95.0|-6.4|27.6||Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).|Cochran-Mantel-Haenszel||||
1610506|NCT02550652|2958208|Superiority||Difference in Percentage of Participants|13.9||||0.09||95.0|-2.4|30.1||Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).|Cochran-Mantel-Haenszel||||
1610507|NCT02550652|2958209|Superiority||Difference in Adjusted Mean|0.085|||<|0.0001||95.0|0.053|0.117|||ANCOVA|Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).|||
1610508|NCT02550652|2958210|Superiority||Difference in Adjusted Mean|0.178||||0.0002|2-Sided|95.0|0.086|0.27|||ANCOVA|Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).|||
1610509|NCT02550652|2958211|Superiority||Difference in Adjusted Mean|-0.811|||<|0.0001|2-Sided|95.0|-1.142|-0.48|||ANCOVA|Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).|||
1610510|NCT02550652|2958212|Superiority|||||||0.2516|||||||Log Rank||||
1610511|NCT02550652|2958213|Superiority||Difference in Percentage of Participants|11.5||||0.9833|2-Sided|95.0|-15.4|14.6||Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).|Cochran-Mantel-Haenszel||||
1610512|NCT02550652|2958214|Superiority||Difference in Percentage of Participants|21.7||||0.015||95.0|4.7|38.7||Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).|Cochran-Mantel-Haenszel||||
1610513|NCT02550652|2958215|Superiority|||||||0.0537|||||||Log Rank||||
1610514|NCT02550652|2958216|Superiority||Difference in Percentage of Participants|20.1||||0.0246||95.0|3.0|37.2||Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).|Cochran-Mantel-Haenszel||||
1610515|NCT02550652|2958217|Superiority||Difference in Percentage of Participants|12.3||||0.1145|2-Sided|95.0|-3.4|28.1||Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).|Cochran-Mantel-Haenszel||||
1610516|NCT02550288|2958235|Superiority or Other||Difference in Least Squares Means|-10.1|||<|0.001|2-Sided|95.0|-13.5|-6.8|||Constrained longitudinal data analysis||||
1610517|NCT02550288|2958235|Superiority or Other||Difference in Least Squares Means|-39.9|||<|0.001|2-Sided|95.0|-44.1|-35.8|||Constrained longitudinal data analysis||||
1610518|NCT02550288|2958235|Superiority or Other||Difference in Least Squares Means|-11.6|||<|0.001|2-Sided|95.0|-14.9|-8.2|||Constrained longitudinal data analysis||||
1610519|NCT02550288|2958235|Superiority or Other||Difference in Least Squares Means|-36.3|||<|0.001|2-Sided|95.0|-40.5|-32.2|||Constrained longitudinal data analysis||||
1610520|NCT02549365|2958313|Other||Odds Ratio (OR)|2.89|||||2-Sided|95.0|0.6|13.9|||||Incidence of laboratory confirmed influenza is compared between those vaccinated and household controls. VE will be calculated as 1 - RR with 95% confidence intervals using Poisson regression.||
1610521|NCT02549352|2958314|Superiority||Week 8 AK count ratio|0.3|||<|0.001|2-Sided|95.0|0.25|0.36||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.037% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1610522|NCT02549352|2958315|Superiority||Ratio of clearance rates|7.59|||<|0.001|2-Sided|95.0|3.7|15.61|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1610523|NCT02549352|2958316|Superiority||Ratio of clearance rates|5.91|||<|0.001|2-Sided|95.0|3.32|10.51|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1610524|NCT02549352|2958317|Superiority||Ratio of clearance rates|7.83|||<|0.001|2-Sided|95.0|2.58|23.71|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.||
1610525|NCT02549339|2958318|Superiority||Week 8 AK count ratio|0.3|||<|0.001|2-Sided|95.0|0.25|0.35||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.018% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1610555|NCT02549040|2958342|Other||Geometric mean ratio|0.9|||||2-Sided|90.0|0.81|1.0||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610526|NCT02549339|2958319|Superiority||Ratio of clearance rates|5.75|||<|0.001|2-Sided|95.0|3.24|10.2|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1610527|NCT02549339|2958320|Superiority||Ratio of clearance rates|5.9|||<|0.001|2-Sided|95.0|3.3|10.54|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1610528|NCT02549339|2958321|Superiority||Ratio of clearance rates|7.57||||0.001|2-Sided|95.0|2.26|25.31|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.||
1610529|NCT02549287|2958322|Superiority||Slope|-0.18||||0.63|2-Sided|95.0|-3.57|3.22||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.|
1610530|NCT02549287|2958323|Superiority||Odds Ratio, log|0.25||||0.47|2-Sided|95.0|-0.39|0.89||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.|
1610531|NCT02549287|2958324|Superiority||Odds Ratio, log|-0.25||||0.44|2-Sided|95.0|-0.79|0.29||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.|
1610532|NCT02549287|2958325|Superiority||Odds Ratio, log|0.05||||0.64|2-Sided|95.0|-0.59|0.69||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.|
1610533|NCT02549287|2958326|Superiority||Slope|-0.75||||0.65|2-Sided|95.0|-3.7|2.2||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.|
1610534|NCT02549287|2958327|Superiority||Odds Ratio, log|-0.22||||0.47|2-Sided|95.0|-0.76|0.32||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.|
1610535|NCT02549287|2958328|Superiority||Odds Ratio, log|-0.11||||0.61|2-Sided|95.0|-0.73|0.52||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.|
1610536|NCT02549287|2958329|Superiority||Odds Ratio, log|0.49||||0.15|2-Sided|95.0|-0.08|1.06||Other [Marginal Model (e.g., GEE)]|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.|
1610537|NCT02549287|2958330|Superiority||Odds Ratio, log|0.35||||0.29|2-Sided|95.0|-0.27|0.97|||Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.|
1610538|NCT02549287|2958331|Superiority||Odds Ratio, log|-0.07||||0.77|2-Sided|95.0|-0.58|0.43||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.|
1610539|NCT02549287|2958332|Superiority||Odds Ratio, log|0.44||||0.2|2-Sided|95.0|-0.2|1.07||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.|
1610540|NCT02549287|2958333|Superiority||Odds Ratio, log|0.41||||0.14|2-Sided|95.0|-0.2|1.03||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.|
1610541|NCT02549287|2958334|Superiority||Odds Ratio, log|0.55||||0.12|2-Sided|95.0|-0.11|1.2||Group by time interaction effect reported here.|Marginal Model (e.g., GEE)|||Intent-to-treat (ITT) framework (multiple imputation used), Multilevel model applied.|
1610542|NCT02549040|2958337|Other||Geometric mean ratio|0.86|||||2-Sided|90.0|0.77|0.96||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610543|NCT02549040|2958337|Other||Geometric mean ratio|0.85|||||2-Sided|90.0|0.76|0.95||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610544|NCT02549040|2958337|Other||Geometric mean ratio|1.06|||||2-Sided|90.0|0.95|1.18||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610545|NCT02549040|2958337|Other||Geometric mean ratio|0.84|||||2-Sided|90.0|0.75|0.94||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610546|NCT02549040|2958340|Other||Geometric mean ratio|0.83|||||2-Sided|90.0|0.74|0.94||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610547|NCT02549040|2958340|Other||Geometric mean ratio|0.85|||||2-Sided|90.0|0.76|0.96||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610548|NCT02549040|2958340|Other||Geometric mean ratio|1.05|||||2-Sided|90.0|0.94|1.18||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610549|NCT02549040|2958340|Other||Geometric mean ratio|0.82|||||2-Sided|90.0|0.72|0.93||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610550|NCT02549040|2958341|Other||Geometric mean ratio|0.76|||||2-Sided|90.0|0.66|0.86||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610551|NCT02549040|2958341|Other||Geometric mean ratio|0.7|||||2-Sided|90.0|0.6|0.81||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610552|NCT02549040|2958341|Other||Geometric mean ratio|0.87|||||2-Sided|90.0|0.75|1.01||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610553|NCT02549040|2958341|Other||Geometric mean ratio|0.7|||||2-Sided|90.0|0.61|0.82||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1611125|NCT02530385|2959896|Superiority|||||||0.7|||||||Mixed Models Analysis||||
1610556|NCT02549040|2958342|Other||Geometric mean ratio|1.09|||||2-Sided|90.0|0.98|1.21||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610557|NCT02549040|2958342|Other||Geometric mean ratio|0.88|||||2-Sided|90.0|0.79|0.98||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610558|NCT02549040|2958343|Other||Geometric mean ratio|0.89|||||2-Sided|90.0|0.8|0.99||||||Comparison of Treatment E: MK-1439 100 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610559|NCT02549040|2958343|Other||Geometric mean ratio|0.99|||||2-Sided|90.0|0.88|1.11||||||Comparison of Treatment D: MK-1439 150 mg tablet (50% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610560|NCT02549040|2958343|Other||Geometric mean ratio|1.13|||||2-Sided|90.0|1.02|1.26||||||Comparison of Treatment C: MK-1439 150 mg tablet (30% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610561|NCT02549040|2958343|Other||Geometric mean ratio|0.96|||||2-Sided|90.0|0.85|1.09||||||Comparison of Treatment B: MK-1439 150 mg tablet (40% drug loaded granule) vs. Treatment A: MK-1439 100 mg film coated tablet|
1610562|NCT02549027|2958344|Superiority or Other||Mean Difference (Final Values)|9.3|||||2-Sided|90.0|-7.1|25.7|||||Difference is MK-6096 – placebo|Mean treatment difference in change from baseline of MK-6096 versus placebo (MK-6096 – placebo) and 90% CI were computed.|
1610563|NCT02549027|2958345|Superiority or Other||Mean Difference (Final Values)|6.38|||||2-Sided|90.0|-8.23|20.98|||||Difference is MK-1064 – placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 – placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.|
1610564|NCT02549027|2958345|Superiority or Other||Mean Difference (Final Values)|5.28|||||2-Sided|90.0|-9.33|19.88|||||Difference is MK-1064 – placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 – placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.|
1610565|NCT02549027|2958345|Superiority or Other||Mean Difference (Final Values)|2.59|||||2-Sided|90.0|-12.01|17.2|||||Difference is MK-1064 – placebo|Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 – placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.|
1610566|NCT02549027|2958346|Superiority or Other||Geometric Mean Ratio|0.63|||||2-Sided|90.0|0.5|0.79|||||Ratio is MK-6096/placebo|Mean log treatment difference of MK-6096 versus placebo (MK-6096 – placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio.|
1610567|NCT02549027|2958347|Superiority or Other||Geometric Mean Ratio|0.75|||||2-Sided|90.0|0.6|0.95|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 – placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.|
1610568|NCT02549027|2958347|Superiority or Other||Geometric Mean Ratio|0.68|||||2-Sided|90.0|0.54|0.86|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 – placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.|
1610569|NCT02549027|2958347|Superiority or Other||Geometric Mean Ratio|0.85|||||2-Sided|90.0|0.67|1.07|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 – placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.|
1610570|NCT02549027|2958350|Superiority or Other||Geometric Mean Ratio|0.05|||||2-Sided|90.0|0.02|0.11|||||Ratio is MK-6096/placebo|Mean log treatment difference of MK-6096 versus placebo (MK-6096 – placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio.|
1610571|NCT02549027|2958351|Superiority or Other||Geometric Mean Ratio|0.15|||||2-Sided|90.0|0.08|0.3|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 – placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.|
1610572|NCT02549027|2958351|Superiority or Other||Geometric Mean Ratio|0.21|||||2-Sided|90.0|0.1|0.41|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 – placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.|
1610609|NCT02546609|2958594|Other|||||||0.3474|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610657|NCT02545868|2958695|Superiority||Normal Distribution Approximation|-55.6|||||2-Sided|95.0|-88.0|-23.1||||||Strain = BPHU13 (Group A2 minus Group B) [Protocol]|
1610573|NCT02549027|2958351|Superiority or Other||Geometric Mean Ratio|0.24|||||2-Sided|90.0|0.12|0.47|||||Ratio is MK-1064/placebo|Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 – placebo) and 90% confidence interval (CI) were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.|
1610574|NCT02548650|2958375|Non-Inferiority|Under the null hypothesis that the mean aggregation between dual and triple therapy is not equal to 0 and a common standard deviation of 13%, a sample size of 28 patients per group with a valid primary end point time point allowed for the 95% confidence interval (CI) to stay within ± 10% with a 80% power and a two-sided alpha=0.05.|Mean Difference (Net)|12.0|||>|0.05|2-Sided|95.0|3.0|21.0|||ANOVA|||The primary end point of our study was the comparison of CAT-induced MPA measured by LTA between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy. We hypothesized that dual therapy would be non-inferior to triple therapy after 30±5 days of treatment|
1610575|NCT02548585|2958400|Superiority|||||||0.0008|||||||ANCOVA|p-value was based on pairwise comparison using ANCOVA adjusted by baseline value.|||
1610576|NCT02548585|2958401|Superiority||||||<|0.0001|||||||ANCOVA|p-value was based on pairwise comparison using analysis of covariance (ANCOVA) adjusted by baseline value.|||
1610577|NCT02548455|2958402|Equivalence|Freedom from left ventricular lead-related complications through 3 months was estimated to be 96.0% with a 95% lower confidence bound of 92.6% based on the Promote Q IDE study (NCT00990665), and 98.3% with a 95% lower confidence bound of 97.7% based on data from the Quadripolar Post-Approval study (NCT01555619).|Kaplan-Meier Estimate|85.0||||0.05|2-Sided||||||Log Rank|||"The hypothesis for the endpoint is:~H0: Freedom from LV lead-related complications through 3 months (91 days) ≤ 85% H1: Freedom from LV lead-related complications through 3 months (91 days) > 85%~A total of 85 subjects were required to have at least 80% power to reject the null hypothesis at the 5% significance level at three months (91 days) post-implant or attempted implant. After accounting for 9% attrition, the required sample size was 94 subjects."|
1610578|NCT02548156|2958410|Superiority or Other||Ratio of LS mean|1.52|||<|0.0001|2-Sided|95.0||||From ANCOVA of log transformed data: subject (random), treatment (fixed) and period (fixed) as factors, participant-level baseline and period-level baseline minus participant-level baseline as covariates.|ANCOVA||Treatment difference from ANCOVA of log transformed data. This therefore represents the ratio of the first named treatment to the second named treatment. A ratio >1 favors the first named treatment.|Test and Reference dentifrice combined vs. Comparator dentifrice|
1610579|NCT02547935|2958481|Superiority||Difference in adjusted mean change|-0.16|Standard Error of the Mean|0.11||0.142|2-Sided|95.0|-0.38|0.05||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e. anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|
1610580|NCT02547935|2958482|Superiority||Difference in adjusted mean change|-2.8|Standard Error of the Mean|1.8||0.122|2-Sided|95.0|-6.4|0.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios, included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation strata, as well as the continuous fixed covariates of log-baseline SBP value and log-baseline SBP value-by-week interaction.|
1610581|NCT02547935|2958482|Superiority||Difference in adjusted mean change|-4.8|Standard Error of the Mean|1.8||0.009|2-Sided|95.0|-8.3|-1.2||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios, included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation strata, as well as the continuous fixed covariates of log-baseline SBP value and log-baseline SBP value-by-week interaction.|
1610582|NCT02547935|2958483|Superiority||Odds Ratio (OR)|1.74||||0.167|2-Sided|95.0|0.8|3.8||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline HbA1c and pooled randomisation strata.|
1610583|NCT02547935|2958483|Superiority||Odds Ratio (OR)|5.43|||<|0.001|2-Sided|95.0|2.6|11.2||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline HbA1c and pooled randomisation strata.|
1610584|NCT02547935|2958484|Superiority||Odds Ratio (OR)|1.86||||0.013|2-Sided|95.0|1.1|3.0||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline UACR and pooled randomisation strata.|
1610585|NCT02547935|2958484|Superiority||Odds Ratio (OR)|2.98|||<|0.001|2-Sided|95.0|1.8|4.8||Statistical significance level = 0.025.|Regression, Logistic|||Logistic regression model analysis with adjustment for baseline UACR and pooled randomisation strata.|
1610586|NCT02547935|2958485|Superiority||Difference in adjusted mean change|-1.9|Standard Error of the Mean|5.9||0.746|2-Sided|95.0|-13.6|9.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e.anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|
1610587|NCT02547935|2958485|Superiority||Difference in adjusted mean change|-6.1|Standard Error of the Mean|5.8||0.298|2-Sided|95.0|-17.5|5.4||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e.anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|
1610588|NCT02547935|2958486|Superiority||Difference in adjusted mean change|-0.87|Standard Error of the Mean|0.66||0.193|2-Sided|95.0|-2.17|0.44||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline total body weight value and log-baseline total body weight value-by-week interaction.|
1611126|NCT02530385|2959897|Superiority|||||||0.16|||||||Wilcoxon (Mann-Whitney)||||
1610589|NCT02547935|2958486|Superiority||Difference in adjusted mean change|-0.04|Standard Error of the Mean|0.66||0.953|2-Sided|95.0|-1.32|1.26||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline total body weight value and log-baseline total body weight value-by-week interaction.|
1610590|NCT02547935|2958487|Superiority||Difference in adjusted mean change|-21.0|Standard Error of the Mean|7.3||0.011|2-Sided|95.0|-34.1|-5.2||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline UACR value and log-baseline UACR value-by-week interaction.|
1610591|NCT02547935|2958487|Superiority||Difference in adjusted mean change|-38.0|Standard Error of the Mean|5.7|<|0.001|2-Sided|95.0|-48.2|-25.8||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures model of the logarithms of the post-baseline to baseline ratios included the fixed categorical effects of treatment, week, treatment-by-week interaction, and randomisation stratification factor (i.e. anti-diabetic treatment strata), as well as the continuous fixed covariates of log-baseline UACR value and log-baseline UACR value-by-week interaction.|
1610592|NCT02547935|2958488|Superiority||Difference in adjusted mean change|-0.58|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|-0.8|-0.37||Statistical significance level = 0.025.|MMRM|||A longitudinal repeated measures analysis included the fixed categorical effects of treatment, week, randomisation stratification factor (i.e. anti-diabetic treatment strata), and treatment-by-week interaction, as well as the continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|
1610593|NCT02547779|2958489|Superiority||Odds Ratio (OR)|0.98|||<|0.05|2-Sided||||||Regression, Logistic||||
1610594|NCT02547779|2958490|Superiority||Odds Ratio (OR)|0.95|||<|0.05|2-Sided||||||Regression, Logistic||||
1610595|NCT02547363|2958548|Superiority||Week 8 AK count ratio|0.27|||<|0.001|2-Sided|95.0|0.23|0.32|||Mantel Haenszel||0.037% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1610596|NCT02547363|2958549|Superiority||Ratio of clearance rates|59.21|||<|0.001|2-Sided|95.0|8.44|415.35|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1610597|NCT02547363|2958550|Superiority||Ratio of clearance rates|62.59|||<|0.001|2-Sided|95.0|8.68|451.08|||Mantel Haenszel||Mantel-Haenszel estimate (0.037% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1610598|NCT02547363|2958551|Superiority||||||<|0.001|||||||Fisher exact test||||
1610599|NCT02547233|2958552|Superiority||Week 8 AK count ratio|0.3|||<|0.001|2-Sided|95.0|0.25|0.37||Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.|Mantel Haenszel||0.018% relative to vehicle.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1610600|NCT02547233|2958553|Superiority||Ratio of clearance rates|10.31|||<|0.001|2-Sided|95.0|4.43|23.97|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1610601|NCT02547233|2958554|Superiority||Ratio of clearance rates|12.26|||<|0.001|2-Sided|95.0|4.73|31.78|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1610602|NCT02547233|2958555|Superiority||Ratio of clearance rates|30.55|||<|0.001|2-Sided|95.0|4.28|218.0|||Mantel Haenszel||Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.||
1610603|NCT02546986|2958580|Superiority||Hazard Ratio (HR)|1.352||||0.199|2-Sided|90.0|0.914|2.0|||Stratified Log-Rank Test|Stratified by squamous cell carcinoma versus non-squamous cell carcinoma|Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model||
1610604|NCT02546986|2958582|Superiority||Overall Response Rate (ORR) Difference|5.3|||||2-Sided|90.0|-11.5|21.3|||||The 90% exact unconditional confidence interval was used for ORR difference.||
1610605|NCT02546986|2958583|Superiority||Hazard Ratio (HR)|1.375||||0.2968|2-Sided|90.0|0.83|2.276|||Stratified Log Rank|Stratified by squamous cell carcinoma vs non-squamous cell carcinoma).|Hazard ratio and associated 2-sided 90% CIs were estimated using Cox proportional hazard model.||
1610606|NCT02546986|2958584|Superiority||Disease Control Rate Difference|-13.3||||0.1572|2-Sided|90.0|-29.0|3.5|||Cochran-Mantel-Haenszel|Stratified by squamous cell carcinoma vs non-squamous cell carcinoma|||
1610607|NCT02546986|2958585|Superiority||Hazard Ratio (HR)|1.374||||0.1789|2-Sided|90.0|0.926|2.038|||Stratified Log-Rank Test|Stratified by squamous cell carcinoma versus non-squamous cell carcinoma|Hazard ratio and associated 2-sided 90% CIs were estimated using a Cox proportional hazard model||
1610608|NCT02546609|2958594|Other|||||||0.8832|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610739|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-32.9|||||2-Sided|95.0|-45.7|-20.1||||||Serotype 8|
1610610|NCT02546609|2958595|Other|||||||0.4697|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610611|NCT02546609|2958595|Other|MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.||||||0.1946|||||||MMRM||||
1610612|NCT02546609|2958596|Other|||||||0.4316|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610613|NCT02546609|2958596|Other|||||||0.0129|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610614|NCT02546609|2958597|Other|||||||0.6221|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610615|NCT02546609|2958597|Other|||||||0.347|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610616|NCT02546609|2958598|Other|||||||0.6221|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610617|NCT02546609|2958598|Other|||||||0.347|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610618|NCT02546609|2958599|Other|||||||0.8366|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610619|NCT02546609|2958599|Other|||||||0.2265|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610620|NCT02546609|2958600|Other|||||||0.9776|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610621|NCT02546609|2958600|Other|||||||0.2559|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610622|NCT02546609|2958601|Other|||||||0.1455|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610623|NCT02546609|2958601|Other|||||||0.4099|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610624|NCT02546609|2958602|Other|||||||0.0164|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610625|NCT02546609|2958602|Other|||||||0.002|||||||MMRM|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610626|NCT02546609|2958603|Other|||||||0.6666|||||||Mixed effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610627|NCT02546609|2958603|Other|||||||0.7742|||||||Mixed effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610628|NCT02546609|2958604|Other|||||||0.8479|||||||Mixed Effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610629|NCT02546609|2958604|Other|||||||0.3811|||||||Mixed Effect Model Repeat Measurement|||MMRM model: with treatment group, visit, and treatment-by-visit interaction as fixed effects, the baseline value of the response variable as a covariate, and subject as a random effect. Placebo is used as the reference group.|
1610630|NCT02546609|2958605|Other|||||||0.377|||||||ANCOVA|||Analysis of variance (ANOVA) model: with treatment group as the factor. Placebo is used as the reference group.|
1610631|NCT02546609|2958605|Other|||||||0.0572|||||||ANCOVA|||Analysis of variance (ANOVA) model: with treatment group as the factor. Placebo is used as the reference group.|
1610632|NCT02546323|2958657|Other||Least squares mean difference|-33.93|Standard Error of the Mean|1.836|<|0.001|2-Sided|95.0|-37.54|-30.32|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C/HDL-C ratio|
1610633|NCT02546323|2958657|Other||Least squares mean difference|-33.78|Standard Error of the Mean|1.529|<|0.001|2-Sided|95.0|-36.78|-30.78|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C|
1610634|NCT02546323|2958657|Other||Least squares mean difference|-18.41|Standard Error of the Mean|2.981|<|0.001|2-Sided|95.0|-24.26|-12.55|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Triglycerides|
1610656|NCT02545868|2958695|Superiority||Normal Distribution Approximation|-78.5|||||2-Sided|95.0|-94.8|-62.2||||||Strain = H3N2SW13 (Group A2 minus Group B) [FDA]|
1610635|NCT02546323|2958657|Other||Least squares mean difference|3.67|Standard Error of the Mean|1.051|<|0.001|2-Sided|95.0|1.6|5.73|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): HDL-C|
1610636|NCT02546323|2958657|Other||Least squares mean difference|-25.46|Standard Error of the Mean|1.139|<|0.001|2-Sided|95.0|-27.7|-23.23|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): total cholesterol|
1610637|NCT02546323|2958657|Other||Least squares mean difference|-39.51|Standard Error of the Mean|1.819|<|0.001|2-Sided|95.0|-43.08|-35.94|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): LDL-C|
1610638|NCT02546323|2958658|Other||Least squares mean difference|-26.77|Standard Error of the Mean|2.041|<|0.001|2-Sided|95.0|-30.78|-22.76|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): ApoB/ApoA-I ratio|
1610639|NCT02546323|2958658|Other||Least squares mean difference|2.19|Standard Error of the Mean|1.104|<|0.047|2-Sided|95.0|0.02|4.36|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate|Treatment difference (rosuvastatin 20 mg - placebo): ApoA-I|
1610640|NCT02546323|2958658|Other||Least squares mean difference|-26.12|Standard Error of the Mean|1.84|<|0.001|2-Sided|95.0|-29.73|-22.5|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): ApoB|
1610641|NCT02546323|2958658|Other||Least squares mean difference|-31.75|Standard Error of the Mean|2.334|<|0.001|2-Sided|95.0|-36.33|-27.16|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C/HDL-C ratio|
1610642|NCT02546323|2958658|Other||Least squares mean difference|-29.49|Standard Error of the Mean|1.917|<|0.001|2-Sided|95.0|-33.25|-25.72|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Non-HDL-C|
1610643|NCT02546323|2958658|Other||Least squares mean difference|-19.65|Standard Error of the Mean|3.671|<|0.001|2-Sided|95.0|-26.86|-12.44|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): Triglycerides|
1610644|NCT02546323|2958658|Other||Least squares mean difference|5.0|Standard Error of the Mean|1.347|<|0.001|2-Sided|95.0|2.35|7.64|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): HDL-C|
1610645|NCT02546323|2958658|Other||Least squares mean difference|-21.85|Standard Error of the Mean|1.441|<|0.001|2-Sided|95.0|-24.68|-19.02|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): total cholesterol|
1610646|NCT02546323|2958658|Other||Least squares mean difference|-35.46|Standard Error of the Mean|2.426|<|0.001|2-Sided|95.0|-40.23|-30.7|||ANCOVA||Treatment as a fixed effect and baseline value as a covariate.|Treatment difference (rosuvastatin 20 mg - placebo): LDL-C|
1610647|NCT02546323|2958659|Other||Estimated mean difference|-0.0086|Standard Error of the Mean|0.00272||0.002|2-Sided|95.0|-0.0139|-0.0032||Statistical significance of the MeanMean CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients|Comparison of annualized rate of change in MeanMean CIMT measurement difference between rosuvastatin 20 mg and placebo|
1610648|NCT02546323|2958660|Other||Estimated mean difference|-0.0043|Standard Error of the Mean|0.00716||0.547|2-Sided|95.0|-0.0183|0.0097||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.|
1610649|NCT02546323|2958661|Other||Estimated mean difference|-0.0162|Standard Error of the Mean|0.00903||0.073|2-Sided|95.0|-0.0339|0.0015||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.|
1610650|NCT02546323|2958662|Other||Estimated mean difference|-0.011|Standard Error of the Mean|0.00442||0.013|2-Sided|95.0|-0.0197|-0.0024||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.|
1610651|NCT02546323|2958663|Other||Estimated mean difference|-0.0103|Standard Error of the Mean|0.00445||0.02|2-Sided|95.0|-0.0191|-0.0016||Statistical significance of the MeanMax CIMT annualized rate of change between rosuvastatin 20 mg and placebo was evaluated using time-by-treatment interaction term in the model.|Multi-level mixed effects model||Randomized treatment group, time, time-by-treatment interaction, ICVD risk stratification, carotid artery site, center, age, sex, and scan reader were fixed effects. Random effects were the intercept and slope for individual patients.|Comparison of annualized rate of change in MeanMax CIMT measurement difference between rosuvastatin 20 mg and placebo.|
1610652|NCT02545868|2958695|Superiority||Normal Distribution Approximation|-6.7|||||2-Sided|95.0|-63.8|50.5||||||Strain = AHK4801 (Group A2 minus Group B) [FDA]|
1610653|NCT02545868|2958695|Superiority||Normal Distribution Approximation|-25.0|||||2-Sided|95.0|-67.4|17.4||||||Strain = BBRIS08 (Group A2 minus Group B) [Protocol]|
1610654|NCT02545868|2958695|Superiority||Normal Distribution Approximation|-36.7|||||2-Sided|95.0|-67.2|-6.1||||||Strain = BBRIS08 (Group A2 minus Group B) [FDA]|
1610655|NCT02545868|2958695|Superiority||Normal Distribution Approximation|-57.8|||||2-Sided|95.0|-100.0|-13.4||||||Strain = H3N2SW13 (Group A2 minus Group B) [Protocol]|
1610658|NCT02545868|2958695|Superiority||Normal Distribution Approximation|-57.9|||||2-Sided|95.0|-77.7|-38.1||||||Strain = BPHU13 (Group A2 minus Group B) [FDA]|
1610659|NCT02545868|2958695|Superiority||Normal Distribution Approximation|-46.0|||||2-Sided|95.0|-88.0|-4.0||||||Strain = H1N1CA09 (Group A2 minus Group B) [Protocol]|
1610660|NCT02545868|2958695|Superiority||Normal Distribution Approximation|-61.3|||||2-Sided|95.0|-80.2|-42.3||||||Strain = H1N1CA09 (Group A2 minus Group B) [FDA]|
1610661|NCT02545868|2958696|Superiority||Normal Distribution Approximation|-6.7|||||2-Sided|95.0|-63.8|50.5||||||Strain = AHK4801 - Difference in at least 4-fold response, Group A2 minus Group B|
1610662|NCT02545868|2958696|Superiority||Normal Distribution Approximation|-36.7|||||2-Sided|95.0|-67.2|-6.1||||||Strain = BBRIS08 - Difference in at least 4-fold response, Group A2 minus Group B|
1610663|NCT02545868|2958696|Superiority||Normal Distribution Approximation|-82.3|||||2-Sided|95.0|-97.1|-67.5||||||Strain = H3N2SW13 - Difference in at least 4-fold response, Group A2 minus Group B|
1610664|NCT02545868|2958696|Superiority||Normal Distribution Approximation|-54.8|||||2-Sided|95.0|-75.3|-34.4||||||Strain = BPHU13 - Difference in at least 4-fold response, Group A2 minus Group B|
1610665|NCT02545868|2958696|Superiority||Normal Distribution Approximation|-61.3|||||2-Sided|95.0|-80.2|-42.3||||||Strain = H1N1CA09 - Difference in at least 4-fold response, Group A2 minus Group B|
1610666|NCT02545868|2958697|Superiority||Normal Distribution Approximation|-3.3|||||2-Sided|95.0|-49.4|42.7||||||Strain = AHK4801 (Group A2 minus Group B)|
1610667|NCT02545868|2958697|Superiority||Normal Distribution Approximation|-45.6|||||2-Sided|95.0|-76.0|-15.1||||||Strain = BBRIS08 (Group A2 minus Group B)|
1610668|NCT02545868|2958697|Superiority||Normal Distribution Approximation|-59.5|||||2-Sided|95.0|-78.2|-40.7||||||Strain = H3N2SW13 (Group A2 minus Group B)|
1610669|NCT02545868|2958697|Superiority||Normal Distribution Approximation|-37.6|||||2-Sided|95.0|-59.7|-15.5||||||Strain = BPHU13 (Group A2 minus Group B)|
1610670|NCT02545868|2958697|Superiority||Normal Distribution Approximation|-41.8|||||2-Sided|95.0|-61.9|-21.7||||||Strain = H1N1CA09 (Group A2 minus Group B)|
1610671|NCT02545868|2958698|Superiority||Normal Distribution Approximation|-3.3|||||2-Sided|95.0|-49.4|42.7||||||Strain = AHK4801 (Group A2 minus Group B)|
1610672|NCT02545868|2958698|Superiority||Normal Distribution Approximation|-19.4|||||2-Sided|95.0|-50.7|11.8||||||Strain = BBRIS08 (Group A2 minus Group B)|
1610673|NCT02545868|2958698|Superiority||Normal Distribution Approximation|-25.9|||||2-Sided|95.0|-45.5|-6.4||||||Strain = H3N2SW13 (Group A2 minus Group B)|
1610674|NCT02545868|2958698|Superiority||Normal Distribution Approximation|-14.0|||||2-Sided|95.0|-35.2|7.3||||||Strain = BPHU13 (Group A2 minus Group B)|
1610675|NCT02545868|2958698|Superiority||Normal Distribution Approximation|-25.5|||||2-Sided|95.0|-41.6|-9.5||||||Strain = H1N1CA09 (Group A2 minus Group B)|
1610676|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-50.0|||||2-Sided|95.0|-68.5|-31.5||||||Serotype 33F- Difference in positive response, Group A2 minus Group B|
1610677|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-47.1|||||2-Sided|95.0|-68.0|-26.1||||||Serotype 23F- Difference in positive response, Group A2 minus Group B|
1610678|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-67.6|||||2-Sided|95.0|-84.8|-50.5||||||Serotype 22F- Difference in positive response, Group A2 minus Group B|
1610679|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-70.6|||||2-Sided|95.0|-87.4|-53.8||||||Serotype 20- Difference in positive response, Group A2 minus Group B|
1610680|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-58.8|||||2-Sided|95.0|-77.6|-40.1||||||Serotype 19F- Difference in positive response, Group A2 minus Group B|
1610681|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-52.9|||||2-Sided|95.0|-72.3|-33.6||||||Serotype 19A- Difference in positive response, Group A2 minus Group B|
1610682|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-61.8|||||2-Sided|95.0|-79.4|-44.2||||||Serotype 18C- Difference in positive response, Group A2 minus Group B|
1610683|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-44.1|||||2-Sided|95.0|-64.0|-24.2||||||Serotype 17F- Difference in positive response, Group A2 minus Group B|
1610684|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-50.0|||||2-Sided|95.0|-69.6|-30.4||||||Serotype 15B- Difference in positive response, Group A2 minus Group B|
1610685|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-17.6|||||2-Sided|95.0|-37.4|2.1||||||Serotype 14- Difference in positive response, Group A2 minus Group B|
1610686|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-58.8|||||2-Sided|95.0|-78.0|-39.6||||||Serotype 12F- Difference in positive response, Group A2 minus Group B|
1610687|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-38.2|||||2-Sided|95.0|-59.3|-17.2||||||Serotype 11A- Difference in positive response, Group A2 minus Group B|
1610688|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-61.8|||||2-Sided|95.0|-79.8|-43.7||||||Serotype 10A- Difference in positive response, Group A2 minus Group B|
1610689|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-38.2|||||2-Sided|95.0|-58.2|-18.2||||||Serotype 9V- Difference in positive response, Group A2 minus Group B|
1610690|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-35.3|||||2-Sided|95.0|-56.4|-14.2||||||Serotype 9N- Difference in positive response, Group A2 minus Group B|
1610691|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-29.4|||||2-Sided|95.0|-46.1|-12.7||||||Serotype 8- Difference in positive response, Group A2 minus Group B|
1610692|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-58.8|||||2-Sided|95.0|-76.7|-40.9||||||Serotype 7F- Difference in positive response, Group A2 minus Group B|
1610693|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-38.2|||||2-Sided|95.0|-59.3|-17.2||||||Serotype 6B- Difference in positive response, Group A2 minus Group B|
1610694|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-52.9|||||2-Sided|95.0|-70.6|-35.3||||||Serotype 5- Difference in positive response, Group A2 minus Group B|
1610695|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-64.7|||||2-Sided|95.0|-82.6|-46.8||||||Serotype 4- Difference in positive response, Group A2 minus Group B|
1610696|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-55.9|||||2-Sided|95.0|-75.3|-36.5||||||Serotype 3- Difference in positive response, Group A2 minus Group B|
1610697|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-52.9|||||2-Sided|95.0|-70.6|-35.3||||||Serotype 2- Difference in positive response, Group A2 minus Group B|
1610698|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-61.8|||||2-Sided|95.0|-78.1|-45.4||||||Serotype 1- Difference in positive response, Group A2 minus Group B|
1610699|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-49.0|||||2-Sided|95.0|-68.2|-29.7||||||Serotype 33F- Difference in positive response, Group A1 minus Group B|
1610700|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-28.1|||||2-Sided|95.0|-50.7|-5.4||||||Serotype 23F- Difference in positive response, Group A1 minus Group B|
1610701|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-52.5|||||2-Sided|95.0|-72.1|-32.8||||||Serotype 22F- Difference in positive response, Group A1 minus Group B|
1610702|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-59.5|||||2-Sided|95.0|-79.0|-40.0||||||Serotype 20- Difference in positive response, Group A1 minus Group B|
1610703|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-46.3|||||2-Sided|95.0|-66.8|-25.8||||||Serotype 19F- Difference in positive response, Group A1 minus Group B|
1610704|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-30.2|||||2-Sided|95.0|-50.6|-9.7||||||Serotype 19A- Difference in positive response, Group A1 minus Group B|
1610705|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-42.5|||||2-Sided|95.0|-61.8|-23.2||||||Serotype 18C- Difference in positive response, Group A1 minus Group B|
1610706|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-46.3|||||2-Sided|95.0|-66.8|-25.8||||||Serotype 17F- Difference in positive response, Group A1 minus Group B|
1610707|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-52.8|||||2-Sided|95.0|-72.8|-32.7||||||Serotype 15B- Difference in positive response, Group A1 minus Group B|
1610708|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-20.8|||||2-Sided|95.0|-41.4|-0.2||||||Serotype 14- Difference in positive response, Group A1 minus Group B|
1610709|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-56.8|||||2-Sided|95.0|-76.9|-36.8||||||Serotype 12F- Difference in positive response, Group A1 minus Group B|
1610710|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-50.1|||||2-Sided|95.0|-71.0|-29.2||||||Serotype 11A- Difference in positive response, Group A1 minus Group B|
1610711|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-62.1|||||2-Sided|95.0|-80.8|-43.5||||||Serotype 10A- Difference in positive response, Group A1 minus Group B|
1610712|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-36.6|||||2-Sided|95.0|-57.3|-16.0||||||Serotype 9V- Difference in positive response, Group A1 minus Group B|
1610713|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-37.2|||||2-Sided|95.0|-58.9|-15.5||||||Serotype 9N- Difference in positive response, Group A1 minus Group B|
1610714|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-42.2|||||2-Sided|95.0|-60.6|-23.8||||||Serotype 8- Difference in positive response, Group A1 minus Group B|
1610715|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-42.5|||||2-Sided|95.0|-61.8|-23.2||||||Serotype 7F- Difference in positive response, Group A1 minus Group B|
1610716|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-34.0|||||2-Sided|95.0|-55.7|-12.2||||||Serotype 6B- Difference in positive response, Group A1 minus Group B|
1610717|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-58.3|||||2-Sided|95.0|-76.4|-40.3||||||Serotype 5- Difference in positive response, Group A1 minus Group B|
1610718|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-56.0|||||2-Sided|95.0|-75.7|-36.3||||||Serotype 4- Difference in positive response, Group A1 minus Group B|
1610719|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-49.8|||||2-Sided|95.0|-70.4|-29.2||||||Serotype 3- Difference in positive response, Group A1 minus Group B|
1610720|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-42.2|||||2-Sided|95.0|-60.6|-23.8||||||Serotype 2- Difference in positive response, Group A1 minus Group B|
1610721|NCT02545868|2958700|Superiority||Normal Distribution Approximation|-45.2|||||2-Sided|95.0|-62.7|-27.6||||||Serotype 1- Difference in positive response, Group A1 minus Group B|
1610722|NCT02545868|2958702|Superiority||Normal Distribution Approximation|-59.7|||||2-Sided|95.0|-72.6|-46.8|||||||
1610723|NCT02545868|2958703|Superiority||Normal Distribution Approximation|-13.4|||||2-Sided|95.0|-21.6|-5.3|||||||
1610724|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-47.8|||||2-Sided|95.0|-62.2|-33.5||||||Serotype 33F|
1610725|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-33.2|||||2-Sided|95.0|-51.7|-14.6||||||Serotype 23F|
1610726|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-56.8|||||2-Sided|95.0|-71.7|-42.0||||||Serotype 22F|
1610727|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-61.5|||||2-Sided|95.0|-77.5|-45.4||||||Serotype 20|
1610728|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-52.5|||||2-Sided|95.0|-68.8|-36.1||||||Serotype 19F|
1610729|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-46.4|||||2-Sided|95.0|-62.5|-30.4||||||Serotype 19A|
1610730|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-52.4|||||2-Sided|95.0|-67.4|-37.3||||||Serotype 18C|
1610731|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-56.9|||||2-Sided|95.0|-72.4|-41.4||||||Serotype 17F|
1610732|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-47.9|||||2-Sided|95.0|-63.9|-32.0||||||Serotype 15B|
1610733|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-25.5|||||2-Sided|95.0|-41.4|-9.7||||||Serotype 14|
1610734|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-55.6|||||2-Sided|95.0|-72.8|-38.3||||||Serotype 12F|
1610735|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-52.5|||||2-Sided|95.0|-69.4|-35.6||||||Serotype 11A|
1610736|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-62.8|||||2-Sided|95.0|-77.2|-48.4||||||Serotype 10A|
1610737|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-40.4|||||2-Sided|95.0|-55.7|-25.1||||||Serotype 9V|
1610738|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-46.4|||||2-Sided|95.0|-62.5|-30.4||||||Serotype 9N|
1610740|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-58.3|||||2-Sided|95.0|-73.1|-43.6||||||Serotype 7F|
1610741|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-37.5|||||2-Sided|95.0|-54.4|-20.7||||||Serotype 6B|
1610742|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-53.8|||||2-Sided|95.0|-68.0|-39.7||||||Serotype 5|
1610743|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-62.8|||||2-Sided|95.0|-77.2|-48.4||||||Serotype 4|
1610744|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-48.0|||||2-Sided|95.0|-65.2|-30.9||||||Serotype 3|
1610745|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-43.3|||||2-Sided|95.0|-56.5|-30.1||||||Serotype 2|
1610746|NCT02545868|2958704|Superiority||Normal Distribution Approximation|-50.7|||||2-Sided|95.0|-62.7|-38.8||||||Serotype 1|
1610747|NCT02545868|2958708|Superiority||normal distribution approximation|-47.0|||||2-Sided|95.0|-63.2|-30.7||||||Difference in positive response, Group A minus Group B|
1610748|NCT02545868|2958709|Superiority||normal distribution approximation|-36.4|||||2-Sided|95.0|-56.0|-16.7||||||Difference in positive response, Group A minus Group B|
1610749|NCT02545868|2958710|Superiority||normal distribution approximation|-30.7|||||2-Sided|95.0|-50.5|-10.8||||||Difference in positive response, Group A minus Group B|
1610750|NCT02545504|2958725|Superiority||ORR Difference|9.4|||||2-Sided|95.0|0.1|18.8|||||The 2-sided 95% confidence interval (CI) of difference for ORR between the treatment and placebo is calculated based on stratum-adjusted Cochran-Mantel-Haenszel proportion.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.|
1610751|NCT02545504|2958725|Superiority||Odds Ratio (OR)|1.47||||0.0493|2-Sided|95.0|1.0|2.15||The significance level at final analysis was 0.032 (two-sided). Stratum with < 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Cochran-Mantel-Haenszel|p-value was stratified by ECOG status, geographic region and primary tumor site.|OR was stratified by ECOG status, geographic region and primary tumor site. Stratum with < 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. ORR was tested only if OS and PFS were significant.The P-value is for display only.|
1610752|NCT02545504|2958726|Superiority||Cox Proportional Hazard|0.84||||0.1031|2-Sided|95.0|0.67|1.04||The significance level at final analysis was 0.032 (two-sided). Stratum with < 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Log Rank|p-value was stratified by ECOG status,geographic region and primary tumor site.|HR was stratified by ECOG status,geographic region;primary tumor site with treatment arm as a covariate.Stratum with <6 participants or no informative event by combined treatment arms was pooled with smallest adjacent stratum for stratified analyses.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint. PFS was tested only if OS was significant. The P-value is for display only.|
1610753|NCT02545504|2958727|Superiority||Cox Proportional Hazard|0.93||||0.5625|2-Sided|95.0|0.74|1.18||The significance level at final analysis is 0.046 (two-sided). Stratum with < 6 participants or no informative event by combined treatment arms was pooled with the smallest adjacent stratum for stratified analyses.|Log Rank|p-value was stratified by Eastern Cooperative Oncology Group (ECOG) status, geographic region and primary tumor site.|Hazard ratio (HR) was stratified by ECOG status, geographic region and primary tumor site with treatment arm as the only covariate.|The primary and secondary endpoints were tested sequentially in the following gate-keeping order: the primary OS endpoint, then the secondary PFS endpoint, and finally the secondary ORR endpoint.|
1610754|NCT02545075|2958750|Superiority||Odds Ratio (OR)|0.98||||0.9738|2-Sided|80.0|0.48|2.03|||Cochran-Mantel-Haenszel||||
1610755|NCT02545075|2958751|Superiority||Odds Ratio (OR)|1.0||||0.9932|2-Sided|80.0|0.64|1.55|||Cochran-Mantel-Haenszel||||
1610756|NCT02545075|2958752|Superiority||Stratified Cox proportional hazard|0.9||||0.2503|2-Sided|80.0|0.71|1.15|||Log Rank|One-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c) and BRAF mutation status as entered into the IVRS|||
1610757|NCT02545075|2958753|Superiority||Stratified cox proportional hazard model|1.13||||0.7267|2-Sided|80.0|0.87|1.45|||Log Rank|One-sided p-value from Log-rank Test stratified by M substage (M1a+M1b vs. M1c)|||
1610758|NCT02545075|2958754|Superiority|||||||0.6202|||||||Chi-squared|One-sided unstratified chi-square|||
1610759|NCT02545075|2958755|Superiority|||||||0.5059|||||||Chi-squared|One-sided p-value based on unstratified chi-square test|||
1610760|NCT02544984|2958760|Superiority|||||||0.435|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy|||
1610761|NCT02544984|2958761|Superiority|||||||0.675|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Numbers of hospital admissions are compared|
1610762|NCT02544984|2958761|Superiority|||||||0.047|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Numbers of emergency room visits are compared|
1610763|NCT02544984|2958761|Superiority|||||||0.505|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||Unscheduled clinic visits due to symptoms other than respiratory symptoms are compared|
1610764|NCT02544984|2958761|Superiority|||||||0.473|||||||negative binomial model|negative binomial model adjusting for use of Synagis and tracheostomy||The numbers of unscheduled clinic visits due to respiratory symptoms are compared.|
1610765|NCT02544633|2958778|Superiority||Objective response rate|0.0|||>|0.999|2-Sided|95.0|0.0|26.46|||Exact test||||
1610766|NCT02544633|2958778|Superiority||Objective response rate|25.0|||>|0.47|2-Sided|95.0|3.19|65.09|||Exact Test||||
1610767|NCT02544633|2958778|Superiority||Objective response rate|15.0|||>|0.79|2-Sided|95.0|3.21|37.89|||exact test||||
1610768|NCT02544633|2958778|Superiority|An exact test for single proportion (two-sided a=5%) will be performed to test H0: ORR <=20% against H1: ORR >20%.|Objective response rate|10.7|||>|0.94|2-Sided|95.0|2.27|28.23|||exact test||||
1610774|NCT02544152|2958813|Other||||||=|0|||||||Cochran-Mantel-Haenszel|||P-value is from a Cochran-Mantel-Haenszel (CMH) test stratified by sex and baseline stool consistency|
1610775|NCT02543918|2958824|Non-Inferiority or Equivalence|Noninferiority of the ixekizumab arm to the control arm for the pneumococcal vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.|Mean Difference (Final Values)|-0.8|||||2-Sided|90.0|-12.9|11.0||||||Pneumococcal vaccine responders|
1610776|NCT02543918|2958824|Non-Inferiority or Equivalence|Noninferiority of the ixekizumab arm to the control arm for the tetanus vaccine was established if the lower limit of the 90% CI excludes an absolute difference of 40% or more.|Mean Difference (Final Values)|1.4|||||2-Sided|90.0|-16.6|19.2||||||Tetanus vaccine responders|
1610777|NCT02542943|2958852|Superiority or Other||LS mean difference|-0.2||||0.4843|2-Sided|95.0|-0.76|0.361||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1610778|NCT02542943|2958852|Superiority or Other||LS mean difference|0.1||||0.7353|2-Sided|95.0|-0.46|0.651||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1610779|NCT02542943|2958852|Superiority or Other||LS mean difference|-0.1||||0.7137|2-Sided|95.0|-0.661|0.453||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1610780|NCT02542943|2958853|Superiority or Other||LS mean difference|-0.33||||0.1663|2-Sided|95.0|-0.788|0.136||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1610781|NCT02542943|2958853|Superiority or Other||LS mean difference|0.17||||0.4538|2-Sided|95.0|-0.284|0.633||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1610782|NCT02542943|2958853|Superiority or Other||LS mean difference|-0.15||||0.517|2-Sided|95.0|-0.611|0.308||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate.|ANCOVA||From ANCOVA model with treatment and baseline Schiff stratification as factors and baseline VRS as covariate. Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1610783|NCT02542943|2958854|Superiority or Other||Median Difference (Net)|0.0||||0.439|2-Sided|95.0|0.0|5.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.||
1610784|NCT02542943|2958854|Superiority or Other||Median Difference (Net)|0.0||||0.8423|2-Sided|95.0|0.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.||
1610785|NCT02542943|2958854|Superiority or Other||Median Difference (Net)|0.0||||0.5631|2-Sided|95.0|0.0|5.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.||
1610786|NCT02542943|2958855|Superiority or Other||Median Difference (Net)|0.0||||0.1419|2-Sided|95.0|0.0|5.0|||Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.||
1610787|NCT02542943|2958855|Superiority or Other||Median Difference (Net)|0.0||||0.1656|2-Sided|95.0|-5.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.||
1610788|NCT02542943|2958855|Superiority or Other||Median Difference (Net)|0.0||||0.8106|2-Sided|95.0|0.0|0.0||From Van Elteren test.|Van Elteren test||Median difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment. From non-parametric Hodges-Lehmann estimations.||
1610789|NCT02542943|2958856|Superiority or Other||LS mean difference|-0.09||||0.4003|2-Sided|95.0|-0.287|0.115||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1610790|NCT02542943|2958856|Superiority or Other||LS mean difference|0.02||||0.8728|2-Sided|95.0|-0.183|0.216||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1610791|NCT02542943|2958856|Superiority or Other||LS mean difference|-0.07||||0.4921|2-Sided|95.0|-0.27|0.13||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1610792|NCT02542943|2958857|Superiority or Other||LS mean difference|-0.21||||0.0873|2-Sided|95.0|-0.445|0.031||From ANCOVA model with treatment as factor and baseline Schiff score as covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1610814|NCT02540265|2959054|Superiority||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, SPID 0-24, SPID 12-24, SPID 12-48, and SPID 24-48|t-test, 2 sided||||
1610815|NCT02540265|2959055|Superiority|||||||0.0076|||||||t-test, 2 sided||||
1610816|NCT02540265|2959055|Superiority|||||||0.0049|||||||t-test, 2 sided||||
1610793|NCT02542943|2958858|Superiority or Other||LS mean difference|0.07||||0.7605|2-Sided|95.0|-0.192|0.34||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett’s multiplicity adjustment is applied.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett’s multiplicity adjustment is applied.||
1610794|NCT02542943|2958858|Superiority or Other||Least square (LS) mean difference|-0.13||||0.435|2-Sided|95.0|-0.4|0.134||From ANCOVA model with treatment as factor and baseline Schiff score as covariate. For the Week 8 comparisons of the two test groups against the control group, Dunnett’s multiplicity adjustment is applied.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment. For Week 8 comparisons of the two test groups against the control group, Dunnett’s multiplicity adjustment is applied.||
1610795|NCT02542865|2958878|Superiority||Mean Difference (Net)|-4.9||||0.039|||||||ANCOVA|ANCOVA:cluster/school=random effect,product group and gender=fixed effects,baseline Individual Dietary Diversity Score=covariate|Difference is difference in back-transformed adjusted means for Test Group minus Control Group. The corresponding CI is not presented as there is no direct back-transformation.|Since the distribution of the data was found to be more skewed with more zero counts than was anticipated at the time the trial was designed, an additional analysis of log (+1)-transformed data was performed.|
1610796|NCT02542865|2958878|Superiority||Mean Difference (Net)|-6.0|Standard Error of the Mean|1.56||0.0628|2-Sided|95.0|-12.7|0.8|||ANCOVA|Analysis of variance(ANCOVA):cluster/school=random effect,product group and gender=fixed effects,baseline Individual Dietary Diversity Score=covariate|Difference is difference in back-transformed adjusted means for Test Group (fortified malt based food plus dietary counselling) minus Control Group (dietary counselling only).||
1610797|NCT02542631|2958885|Superiority|||||||1|||||||Chi-squared||||
1610798|NCT02542631|2958886|Superiority||Mean Difference (Final Values)|4.32|Standard Error of the Mean|2.03||0.03|2-Sided|95.0|0.33|8.32||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.|||
1610799|NCT02542631|2958887|Superiority||Mean Difference (Final Values)|9.16|Standard Error of the Mean|2.8||0.001|2-Sided|95.0|3.65|14.67||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.|||
1610800|NCT02542631|2958888|Superiority||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.09||0.52|2-Sided|95.0|-0.12|0.24||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with treatment group as a factor and week 24 value as a covariate was used to compare devices for continuous measures.|||
1610801|NCT02542631|2958889|Superiority||Odds Ratio (OR)|1.1|Standard Error of the Mean|0.28||0.71|2-Sided|95.0|0.64|1.93||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|Cochran-Mantel-Haenszel||||
1610802|NCT02542631|2958890|Superiority||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.14||0.99|2-Sided|95.0|-0.28|0.28||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.|||
1610803|NCT02542631|2958891|Superiority||Mean Difference (Final Values)|-2.97|Standard Error of the Mean|3.36||0.38|2-Sided|95.0|-9.63|3.7||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|ANCOVA|ACNOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.|||
1610804|NCT02542631|2958892|Superiority||Odds Ratio (OR)|1.3|Standard Error of the Mean|0.25||0.26|2-Sided|95.0|0.81|2.14||Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.|Cochran-Mantel-Haenszel||||
1610805|NCT02542631|2958893|Non-Inferiority|The sample size determination was based on the primary endpoint, A1C change from Baseline to Week 24. Assuming that the true mean difference in A1C change for Finesse versus Pen was -0.1% with a SD of 1.2%, a study population of 250 completers (125 per arm) was required to achieve a power of 90% for non-inferiority with a margin of 0.4%.|Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.32|0.14||Non-inferiority p-value was calculated with 2-sided comparison of the difference in treatment effects between Finesse and Pen with a non-inferiority margin of 0.4%.|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.|||
1610806|NCT02542462|2958918|Superiority|||||||0.3||||||P value for change in the number of subjects with an increase in number of lymph nodes from pre to post was 0.3.|Fisher Exact|||The test is to see a difference among the four groups and the pre to post change of the primary outcomes|
1610807|NCT02542462|2958918|Superiority|||||||0.2||||||P value for the number of subjects with an increase of 1 mm or more of terminal ileum from pre to post was 0.2|Fisher Exact|||The test is to see a difference among the four groups and the pre to post change of the primary outcomes|
1610808|NCT02541422|2958989|Superiority|||||||0.72||||||p value calculated for symptom of weakness|Wilcoxon (Mann-Whitney)||||
1610809|NCT02541422|2958989|Superiority|||||||0.11||||||p value calculated for symptom of nausea|Wilcoxon (Mann-Whitney)||||
1610810|NCT02541422|2958989|Superiority|||||||0.93||||||p value calculated for symptom of headache|Wilcoxon (Mann-Whitney)||||
1610811|NCT02541422|2958989|Superiority|||||||0.45||||||p-value calculated for the total hangover scale|Wilcoxon (Mann-Whitney)||||
1610812|NCT02540629|2959008|Equivalence|Chi-squared test||||||0.01|||||||Chi-squared||||
1610813|NCT02540265|2959054|Superiority||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, SPID 0-24, SPID 12-24, SPID 12-48, and SPID 24-48|t-test, 2 sided||||
1610817|NCT02540265|2959056|Other||Effect Size|0.87|||||2-Sided||||||||||
1610819|NCT02539225|2959146|Superiority||Odds Ratio (OR)|1.527||||0.501|2-Sided|80.0|0.68|3.433|||Cochran-Mantel-Haenszel||||
1610820|NCT02539225|2959147|Superiority||Odds Ratio (OR)|1.374||||0.402|2-Sided|80.0|0.844|2.236|||Cochran-Mantel-Haenszel||||
1610821|NCT02539225|2959148|Superiority|||||||0.548|||||||Log Rank Stratified||||
1610822|NCT02539225|2959149|Superiority|||||||0.549|||||||Log Rank Stratified||||
1610823|NCT02539225|2959150|Superiority|||||||0.698|||||||Stratified Log Rank||||
1610824|NCT02539134|2959151|Superiority or Other||Slope|1.36||||0.039|2-Sided|90.0|1.08|1.642|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.|
1610825|NCT02539134|2959152|Superiority or Other||Slope|1.19||||0.288|2-Sided|90.0|0.89|1.489|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90% CI for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.|
1610826|NCT02539134|2959153|Superiority or Other||Slope|1.37||||0.036|2-Sided|90.0|1.089|1.657|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.|
1610827|NCT02539134|2959153|Superiority or Other||Slope|1.2||||0.191|2-Sided|90.0|0.946|1.45|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90% CI for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.|
1610828|NCT02539134|2959154|Superiority or Other||Slope|1.37||||0.042|2-Sided|90.0|1.078|1.664|||Power model|||Day 14: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 14 was assessed using the power model. For Day 14, the criteria for dose proportionality was the 90% CI for the slope within (0.839, 1.161) for the dose range of 100 mg to 400 mg.|
1610829|NCT02539134|2959154|Superiority or Other||Slope|1.06||||0.757|2-Sided|90.0|0.741|1.374|||Power model|||Day 1: For groups with QD dosing, dose proportionality for TAK-935 plasma exposure on Day 1 was assessed using the power model. For Day 1, the criteria for dose proportionality was the 90 percent (%) confidence interval (CI) for the slope within (0.875, 1.125) for the dose range of 100 mg to 600 mg.|
1610830|NCT02538666|2959183|Superiority||Hazard Ratio (HR)|0.69|||||2-Sided|95.0|0.53|0.9|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff <13 mutations/mb: Nivo over placebo|
1610831|NCT02538666|2959183|Superiority||Hazard Ratio (HR)|0.78|||||2-Sided|95.0|0.6|1.01|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff <13 mutations/mb: Nivo+Ipi over placebo|
1610832|NCT02538666|2959183|Superiority||Hazard Ratio (HR)|0.68|||||2-Sided|95.0|0.5|0.92|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff <10 mutations/mb: Nivo over placebo|
1610833|NCT02538666|2959183|Superiority||Hazard Ratio (HR)|0.72|||||2-Sided|95.0|0.53|0.97|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff <10 mutations/mb: Nivo+Ipi over placebo|
1610834|NCT02538666|2959183|Superiority||Hazard Ratio (HR)|0.68|||||2-Sided|95.0|0.47|0.99|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo over placebo|
1610835|NCT02538666|2959183|Superiority||Hazard Ratio (HR)|0.69|||||2-Sided|95.0|0.47|1.03|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo|
1610836|NCT02538666|2959183|Superiority||Hazard Ratio (HR)|0.7|||||2-Sided|95.0|0.51|0.95|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo over placebo|
1610837|NCT02538666|2959183|Superiority||Hazard Ratio (HR)|0.76|||||2-Sided|95.0|0.56|1.05|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo|
1610838|NCT02538666|2959184|Superiority||Hazard Ratio (HR)|0.92|||||2-Sided|95.0|0.7|1.22|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff <13 mutations/mb: Nivo over placebo|
1610839|NCT02538666|2959184|Superiority||Hazard Ratio (HR)|1.04|||||2-Sided|95.0|0.79|1.37|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff <13 mutations/mb: Nivo+Ipi over placebo|
1610840|NCT02538666|2959184|Superiority||Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.65|1.22|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff <10 mutations/mb: Nivo over placebo|
1610841|NCT02538666|2959184|Superiority||Hazard Ratio (HR)|0.94|||||2-Sided|95.0|0.69|1.28|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff <10 mutations/mb: Nivo+Ipi over placebo|
1610842|NCT02538666|2959184|Superiority||Hazard Ratio (HR)|0.67|||||2-Sided|95.0|0.45|1.01|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo over placebo|
1610843|NCT02538666|2959184|Superiority||Hazard Ratio (HR)|0.61|||||2-Sided|95.0|0.39|0.94|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥13 mutations/mb: Nivo+Ipi over placebo|
1610844|NCT02538666|2959184|Superiority||Hazard Ratio (HR)|0.76|||||2-Sided|95.0|0.54|1.07|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo over placebo|
1610845|NCT02538666|2959184|Superiority||Hazard Ratio (HR)|0.79|||||2-Sided|95.0|0.55|1.12|||||Unstratified Cox proportional hazard model. Hazard Ratios are experimental treatment group over placebo.|TMB cutoff ≥10 mutations/mb: Nivo+Ipi over placebo|
1610846|NCT02538666|2959185|Superiority||Hazard Ratio (HR)|1.08|||||2-Sided|95.0|0.89|1.3|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|nivo+ ipi over nivo|
1610847|NCT02538666|2959185|Superiority||Hazard Ratio (HR)|0.67|||||2-Sided|95.0|0.56|0.81|||||Hazard Ratios based on stratified 3-arms Cox proportional hazard model|nivo over placebo|
1610848|NCT02538666|2959185|Superiority||Hazard Ratio (HR)|0.72|||||2-Sided|95.0|0.6|0.87|||||Hazard Ratios based on stratified 3-arms Cox proportional hazard model|nivo + ipi over placebo|
1610849|NCT02538666|2959186|Superiority||Hazard Ratio (HR)|1.09|||||2-Sided|95.0|0.89|1.33|||||Hazard Ratios are based on stratified 3-arms Cox proportional hazard model.|nivo + ipi over nivo|
1610850|NCT02538666|2959186|Superiority||Hazard Ratio (HR)|0.84|||||2-Sided|95.0|0.69|1.02|||||based on stratified 3-arms Cox proportional hazard model|nivo over placebo|
1610851|NCT02538666|2959187|Superiority||Hazard Ratio (HR)|0.92||||0.3693|2-Sided|95.0|0.75|1.12|||Stratified Log Rank|Stratified by response to ECOG PS (0vs1), gender (MvF), irradiation following chemotherapy (YorN) as entered in IVRS|based on stratified 3-arms Cox proportional hazard model|nivo + ipi over placebo|
1610852|NCT02538523|2959188|Superiority||||||<|0.05|||||||ANCOVA|||Differences is the statistical significance of change scores in ODI total score from study baseline to endpoint (two-months post-procedure) were evaluated by Analysis of Covariance (ANCOVA), with change from baseline to endpoint in ODI total score as the dependent variable, baseline ODI total score as the covariate and procedure group (Erchonia FX-635 or placebo laser) as a main effect.|
1610853|NCT02538523|2959189|Superiority||||||<|0.005|||||||Fisher Exact|||A Fischer’s Exact Test for two independent proportions was conducted to compare the statistical significance of the 44.8% difference in proportion of successes between procedure groups at two-months post-procedure (study endpoint) relative to baseline evaluation.|
1610854|NCT02538042|2959221|Superiority|||||||0.39|||||||ANOVA||||
1610855|NCT02537574|2959247|Superiority||Odds Ratio (OR)|0.8|Standard Error of the Mean|0.207||0.383|2-Sided|95.0|0.48|1.33|||Regression, Logistic||||
1610856|NCT02537574|2959247|Superiority||Odds Ratio (OR)|1.02|Standard Error of the Mean|0.264||0.94|2-Sided|95.0|0.61|1.7|||Regression, Logistic||||
1610857|NCT02537431|2959251|Other||LS mean|-27.3|||||2-Sided|95.0|-52.33|-2.28|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|EOSII|
1610858|NCT02537431|2959251|Other||LS mean|6.92|||||2-Sided|95.0|-13.44|27.28|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 96|
1610859|NCT02537431|2959251|Other||LS mean|15.13|||||2-Sided|95.0|-11.19|41.46|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 72|
1610860|NCT02537431|2959251|Other||l|24.35||||0.1672|2-Sided|95.0|-10.2|58.9|||GEE model||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 48|
1610861|NCT02537431|2959251|Other||LS Mean|31.37|||||2-Sided|95.0|8.23|54.51|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 24|
1610862|NCT02537431|2959251|Other||LS Mean|52.54|||||2-Sided|95.0|21.18|83.9|||||From the GEE model, which includes the percent change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 12|
1610863|NCT02537431|2959252|Other||LS mean|-5.8|||||2-Sided|95.0|-12.46|0.85|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|EOSII|
1610864|NCT02537431|2959252|Other||LS mean|1.14|||||2-Sided|95.0|-2.84|5.11|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 96|
1610865|NCT02537431|2959252|Other||LS mean|3.13|||||2-Sided|95.0|-1.64|7.9|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 72|
1610866|NCT02537431|2959252|Other||LS Mean|4.5||||0.2592|2-Sided|95.0|-3.32|12.32|||GEE model||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 48|
1610867|NCT02537431|2959252|Other||LS Mean|5.82|||||2-Sided|95.0|-0.02|11.66|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 24|
1610868|NCT02537431|2959252|Other||LS Mean|10.93|||||2-Sided|95.0|3.98|17.89|||||From the GEE model, which includes the change from baseline for Bone ALP as the dependent variable, visit as fixed factors, and baseline of Bone ALP as a covariate, with compound symmetry covariance structure.|Week 12|
1610869|NCT02537431|2959253|Other||LS mean|17.88|||||2-Sided|95.0|-0.32|36.07|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|EOSII|
1610870|NCT02537431|2959253|Other||LS mean|25.86|||||2-Sided|95.0|9.27|42.44|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 96|
1610871|NCT02537431|2959253|Other||LS mean|34.0|||||2-Sided|95.0|6.53|61.47|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 72|
1610872|NCT02537431|2959253|Other||LS Mean|35.86|||<|0.0001|2-Sided|95.0|21.37|50.36|||GEE model||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 48|
1610873|NCT02537431|2959253|Other||LS Mean|70.17|||<||2-Sided|95.0|49.9|90.44|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 24|
1610874|NCT02537431|2959253|Other||LS Mean|89.68|||<||2-Sided|95.0|63.58|115.78|||||From the GEE model which includes the percent change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 12|
1610875|NCT02537431|2959254|Other||LS mean|-41.32|||||2-Sided|95.0|-204.28|121.64|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|EOSII|
1610876|NCT02537431|2959254|Other||LS mean|76.8|||||2-Sided|95.0|-35.62|189.22|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 96|
1610877|NCT02537431|2959254|Other||LS mean|143.11|||||2-Sided|95.0|-38.2|324.41|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 72|
1610878|NCT02537431|2959254|Other||LS Mean|175.13|||<|0.0001|2-Sided|95.0|88.85|261.41|||GEE model||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 48|
1610879|NCT02537431|2959254|Other||LS Mean|404.13|||<||2-Sided|95.0|294.47|513.78|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 24|
1610880|NCT02537431|2959254|Other||LS Mean|464.84|||<||2-Sided|95.0|343.92|585.77|||||From the GEE model which includes the change from baseline for CTx as the dependent variable, visit as fixed factors, and baseline of CTx as a covariate, with compound symmetry covariance structure.|Week 12|
1610881|NCT02537431|2959255|Other||LS mean|26.2|||||2-Sided|95.0|6.76|45.64|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|EOSII|
1610882|NCT02537431|2959255|Other||LS mean|41.36|||||2-Sided|95.0|18.69|64.03|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 96|
1610883|NCT02537431|2959255|Other||LS mean|50.46|||||2-Sided|95.0|23.69|77.23|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 72|
1610884|NCT02537431|2959255|Other||LS Mean|76.86|||<|0.0001|2-Sided|95.0|49.2|104.53|||GEE model||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 48|
1610885|NCT02537431|2959255|Other||LS Mean|137.8|||<||2-Sided|95.0|106.95|168.65|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 24|
1610886|NCT02537431|2959255|Other||LS Mean|133.08|||<||2-Sided|95.0|106.26|159.89|||||From the GEE model, which includes the percent change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 12|
1610887|NCT02537431|2959256|Other||LS mean|2.14|||||2-Sided|95.0|-17.67|21.94|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|EOSII|
1610888|NCT02537431|2959256|Other||LS mean|29.29|||||2-Sided|95.0|3.18|55.4|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 96|
1610889|NCT02537431|2959256|Other||LS mean|37.29|||||2-Sided|95.0|13.19|61.38|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 72|
1610890|NCT02537431|2959256|Other||LS Mean|52.49|||<|0.0001|2-Sided|95.0|29.84|75.13|||GEE model||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 48|
1610891|NCT02537431|2959256|Other||LS Mean|104.33|||<||2-Sided|95.0|82.47|126.19|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 24|
1610892|NCT02537431|2959256|Other||LS Mean|99.18|||<||2-Sided|95.0|76.83|121.53|||||From the GEE model, which includes the change from baseline for P1NP as the dependent variable, visit as fixed factors, and baseline of P1NP as a covariate, with compound symmetry covariance structure.|Week 12|
1610893|NCT02537431|2959257|Other||LS mean|0.01|||||2-Sided|95.0|-0.01|0.03|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|EOSII|
1610894|NCT02537431|2959257|Other||LS mean|0.02|||||2-Sided|95.0|-0.01|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 96|
1610895|NCT02537431|2959257|Other||LS mean|0.02|||||2-Sided|95.0|-0.01|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 84|
1610896|NCT02537431|2959257|Other||LS mean|-0.02|||||2-Sided|95.0|-0.09|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 72|
1610897|NCT02537431|2959257|Other||LS mean|0.03|||||2-Sided|95.0|0.0|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 60|
1610898|NCT02537431|2959257|Other||LS Mean|0.0||||0.8377|2-Sided|95.0|-0.05|0.04|||GEE model||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 48|
1610899|NCT02537431|2959257|Other||LS Mean|0.01|||||2-Sided|95.0|-0.02|0.04||||||Week 24|
1610900|NCT02537431|2959257|Other||LS Mean|0.04|||||2-Sided|95.0|0.02|0.05|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 22|
1610901|NCT02537431|2959257|Other||LS Mean|0.01|||||2-Sided|95.0|-0.01|0.04|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 12|
1610902|NCT02537431|2959257|Other||LS Mean|0.03|||||2-Sided|95.0|0.01|0.06|||||From the GEE model which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 4|
1610903|NCT02537431|2959257|Other||LS Mean|0.07|||||2-Sided|95.0|0.06|0.08|||||From the GEE model, which includes the change from baseline or percent change from baseline for TRP as the dependent variable, visit as fixed factors, and baseline of TRP as a covariate, with compound symmetry covariance structure.|Week 2|
1610904|NCT02537431|2959258|Other||LS mean|0.21|||||2-Sided|95.0|0.08|0.34|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|EOSII|
1610905|NCT02537431|2959258|Other||LS mean|0.29|||||2-Sided|95.0|0.1|0.48|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 96|
1610906|NCT02537431|2959258|Other||LS mean|0.39|||||2-Sided|95.0|0.13|0.66|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 84|
1610907|NCT02537431|2959258|Other||LS mean|0.28|||||2-Sided|95.0|0.03|0.52|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 72|
1610908|NCT02537431|2959258|Other||LS mean|0.3|||||2-Sided|95.0|-0.04|0.64|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 60|
1610909|NCT02537431|2959258|Other||LS Mean|0.2||||0.043|2-Sided|95.0|0.01|0.38|||GEE model||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 48|
1610910|NCT02537431|2959258|Other||LS Mean|0.44|||||2-Sided|95.0|0.24|0.64|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 24|
1610911|NCT02537431|2959258|Other||LS Mean|0.87|||||2-Sided|95.0|0.74|0.99|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 22|
1610912|NCT02537431|2959258|Other||LS Mean|0.58|||||2-Sided|95.0|0.34|0.82|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 12|
1610913|NCT02537431|2959258|Other||LS Mean|0.78|||||2-Sided|95.0|0.59|0.97|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 4|
1610914|NCT02537431|2959258|Other||LS Mean|1.76|||||2-Sided|95.0|1.49|2.03|||||From the GEE model, which includes the change from baseline for TmP/GFR as the dependent variable, visit as fixed factors, and baseline of TmP/GFR as a covariate, with compound symmetry covariance structure.|Week 2|
1610915|NCT02537431|2959259|Other||LS mean|-0.07|||||2-Sided|95.0|-0.41|0.26|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|EOS II|
1610916|NCT02537431|2959259|Other||LS mean|-0.13|||||2-Sided|95.0|-0.29|0.03|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 96|
1610917|NCT02537431|2959259|Other||LS mean|0.0|||||2-Sided|95.0|-0.19|0.19|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 72|
1610918|NCT02537431|2959259|Other||LS Mean|-0.04||||0.6021|2-Sided|95.0|-0.19|0.11|||GEE model||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 48|
1610919|NCT02537431|2959259|Other||LS Mean|-0.01|||||2-Sided|95.0|-0.12|0.11|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 36|
1610920|NCT02537431|2959259|Other||LS Mean|-0.04|||||2-Sided|95.0|-0.19|0.11|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 24|
1610921|NCT02537431|2959259|Other||LS Mean|0.1|||||2-Sided|95.0|-0.15|0.35|||||From the GEE model; includes change from baseline from baseline for 24-Hour urinary phosphorus as the dependent variable, visit as fixed factors, and baseline of 24-Hour urinary phosphorus as a covariate, with compound symmetry covariance structure.|Week 12|
1610922|NCT02537431|2959260|Other||LS mean|-1.69|||||2-Sided|95.0|-5.6|2.21|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 132|
1610923|NCT02537431|2959260|Other||LS mean|1.45|||||2-Sided|95.0|-6.77|9.68|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 120|
1610924|NCT02537431|2959260|Other||LS mean|0.02|||||2-Sided|95.0|-9.22|9.26|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 108|
1610925|NCT02537431|2959260|Other||LS mean|-6.09|||||2-Sided|95.0|-10.8|-1.38||||||Week 96|
1610926|NCT02537431|2959260|Other||LS mean|9.63|||||2-Sided|95.0|1.33|17.94|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 94|
1610927|NCT02537431|2959260|Other||LS mean|-5.55|||||2-Sided|95.0|-11.35|0.26|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 84|
1610928|NCT02537431|2959260|Other||LS mean|-5.55|||||2-Sided|95.0|-11.22|0.13|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 72|
1610929|NCT02537431|2959260|Other||LS mean|3.36|||||2-Sided|95.0|-4.45|11.18|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 70|
1610930|NCT02537431|2959260|Other||LS mean|-5.73|||||2-Sided|95.0|-12.38|0.92|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 60|
1610931|NCT02537431|2959260|Other||LS Mean|-1.72||||0.6821|2-Sided|95.0|-9.93|6.5|||GEE model||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 48|
1610932|NCT02537431|2959260|Other||LS Mean|-3.04|||||2-Sided|95.0|-12.62|6.55|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 24|
1610933|NCT02537431|2959260|Other||LS Mean|11.5|||||2-Sided|95.0|3.54|19.46|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 22|
1610934|NCT02537431|2959260|Other||LS Mean|31.75|||||2-Sided|95.0|21.49|42.0|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 21|
1610935|NCT02537431|2959260|Other||LS Mean|-1.34|||||2-Sided|95.0|-8.43|5.75|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 20|
1610936|NCT02537431|2959260|Other||LS Mean|13.58|||||2-Sided|95.0|6.85|20.31|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 4|
1610937|NCT02537431|2959260|Other||LS Mean|48.41|||||2-Sided|95.0|33.91|62.91|||||From the GEE model which includes the change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 2|
1610938|NCT02537431|2959260|Other||Least Squares Mean (GEE)|107.75|||||2-Sided|95.0|76.46|139.03|||||From the generalized estimation equation (GEE) model which includes change from baseline for 1, 25 (OH)2 D as the dependent variable, visit as fixed factors, and baseline of 1, 25 (OH)2 D as a covariate, with compound symmetry covariance structure.|Week 1|
1610939|NCT02537431|2959272|Other||Mean|-52.24||||0.0199|2-Sided|95.0|-94.08|-10.41||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test||||
1610940|NCT02537431|2959273|Other||Mean|-26.0||||0.0002|2-Sided|95.0|-36.08|-15.91||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test||||
1610941|NCT02537431|2959274|Other||Mean|-32.21|||<|0.0001|2-Sided|95.0|-40.25|-24.17||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test||||
1610942|NCT02537431|2959275|Other||||||<|0.0001||||||The p-value is for testing the proportion of participants achieving the mean serum phosphorus levels above the LLN (2.5 mg/dL [0.81 mmol/L]) against 0% from the binomial test.|binomial test||||
1610943|NCT02537431|2959276|Other||Mean|-54.18|||<|0.0001|2-Sided|95.0|-68.64|-39.72||The null hypothesis of no mean percent change from baseline is tested using t-test.|t-test||||
1610944|NCT02535715|2959346|Superiority|ANOVA Bonferroni adjustment|||||<|0.05|||||||ANOVA||||
1610945|NCT02535026|2959385|Superiority or Other||||||<|0.001|||||||ANOVA|||phenotypes of breast cancer association with HER2 status.|
1610946|NCT02535026|2959386|Superiority or Other||||||<|0.001|||||||ANOVA|||Phenotypes of breast cancer association with PR status.|
1610947|NCT02535026|2959387|Superiority or Other||||||<|0.001|||||||ANOVA|||phenotypes of breast cancer association with ER status.|
1610948|NCT02535026|2959388|Superiority or Other||||||=|0|||||||ANOVA|||phenotypes of breast cancer association with lymphovascular invasion.|
1610949|NCT02535026|2959389|Superiority or Other||||||<|0.001|||||||ANOVA|||Breast cancer phenotypes association with nuclear grades.|
1610950|NCT02535026|2959390|Superiority or Other||||||=|0|||||||ANOVA|||Breast cancer phenotypes association with age groups.|
1610951|NCT02535026|2959391|Superiority or Other||||||=|0|||||||Chi-squared||||
1610952|NCT02535026|2959392|Superiority or Other||||||<|0.001|||||||Chi-squared|||HER2 status association with nuclear grade.|
1610953|NCT02535026|2959393|Superiority or Other||||||=|0|||||||ANOVA|||HER2 status association with age groups.|
1610954|NCT02535026|2959394|Superiority or Other||||||=|0|||||||ANOVA|||PR status association with lymphovascular invasion.|
1610955|NCT02535026|2959395|Superiority or Other||||||<|0.001|||||||Chi-squared|||PR status association with nuclear grade.|
1610956|NCT02535026|2959396|Superiority or Other||||||=|0|||||||Chi-squared|||PR status association with age groups|
1610957|NCT02535026|2959397|Superiority or Other||||||=|0|||||||Chi-squared|||ER status association with lymphovascular invasion.|
1610958|NCT02535026|2959398|Superiority or Other||||||<|0.001|||||||Chi-squared|||ER status association with nuclear grade.|
1610959|NCT02535026|2959399|Superiority or Other|||||||0.28|||||||Chi-squared|||ER status association with age groups|
1610960|NCT02534896|2959421|Superiority|||||||0.374|||||||Hochberg and Gatekeeping||||
1610961|NCT02534896|2959421|Superiority|||||||0.573|||||||Hochberg and Gatekeeping||||
1610962|NCT02534896|2959422|Superiority|||||||0.339|||||||Hochberg and Gatekeeping||||
1610963|NCT02534896|2959422|Superiority|||||||0.96|||||||Hochberg and Gatekeeping||||
1610964|NCT02534896|2959423|Superiority|||||||0.003|||||||Hochberg and Gatekeeping||||
1610965|NCT02534896|2959423|Superiority|||||||0.028|||||||Hochberg and Gatekeeping||||
1610966|NCT02534896|2959424|Superiority|||||||0.007|||||||Hochberg and Gatekeeping||||
1610967|NCT02534896|2959424|Superiority|||||||0.018|||||||Hochberg and Gatekeeping||||
1610968|NCT02534350|2959433|Superiority||Treatment Difference|-3.25||||0.6|2-Sided|95.0|-15.58|9.08|||ANCOVA||||
1610969|NCT02534350|2959434|Superiority||Treatment Difference|0.01||||0.86|2-Sided|95.0|-0.12|0.15|||ANCOVA||||
1610970|NCT02534350|2959435|Superiority||Treatment Difference|-0.12||||0.76|2-Sided|95.0|-0.94|0.69|||ANCOVA||||
1610971|NCT02534350|2959436|Superiority||Treatment Difference|0.1||||0.72|2-Sided|95.0|-0.43|0.63|||ANCOVA||||
1610972|NCT02534324|2959437|Superiority or Other|||||||0.15|||||||t-test, 2 sided||||
1610973|NCT02534324|2959438|Superiority or Other|||||||0.49|||||||Chi-squared||||
1610974|NCT02533921|2959448|Superiority||Mean Difference (Final Values)|-0.1608|Standard Error of the Mean|0.3934||0.6834|2-Sided|95.0|-0.9382|0.6167|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.|
1610975|NCT02533921|2959449|Superiority||Mean Difference (Final Values)|-0.6878|Standard Error of the Mean|0.4789||0.1529|2-Sided|95.0|-1.6338|0.2581|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.|
1610976|NCT02533921|2959450|Superiority||Mean Difference (Final Values)|-0.1309||||0.7484|2-Sided|95.0|-0.9349|0.673|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.||
1610977|NCT02533921|2959451|Superiority||Mean Difference (Final Values)|-0.4616|Standard Error of the Mean|0.3889||0.2369|2-Sided|95.0|-1.2291|0.3059|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.|
1610978|NCT02533921|2959452|Superiority||Mean Difference (Final Values)|-1.1236|Standard Error of the Mean|0.8267||0.1761|2-Sided|95.0|-2.7569|0.5097|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.|
1610979|NCT02533921|2959453|Superiority||Mean Difference (Final Values)|1.5022|Standard Error of the Mean|0.6749||0.0272|2-Sided|95.0|0.1706|2.8338|||Mixed Models Analysis||Compares the palliative care plus usual care group to the usual care group.|Comparing the mean within group change from baseline to 6 months between groups. The null hypothesis is there is no mean difference between groups.|
1610980|NCT02533726|2959455|Other||Odds Ratio (OR)|0.2||||0.015|2-Sided|95.0|0.06|0.74|||Fisher Exact|||Per protocol analysis adjusted for admitting team, unit of admission, and risk for pressure injury.|
1610981|NCT02533726|2959455|Superiority||Odds Ratio (OR)|0.27||||0.012|2-Sided|95.0|0.1|0.75|||Fisher Exact|||Per-protocol (PP) analysis, consistent with regulatory guidance (FDA).|
1610982|NCT02533505|2959460|Superiority||Mean Difference (Final Values)|0.019||||0.007|2-Sided|95.0|0.005|0.033|||Mixed Models Analysis|||ΔFEV1/FVC|
1610983|NCT02533505|2959461|Superiority||Mean Difference (Final Values)|862.157|||<|0.001|2-Sided|95.0|439.817|1284.496|||Mixed Models Analysis|||ΔVe|
1610984|NCT02533505|2959462|Superiority||Mean Difference (Final Values)|57.624|||<|0.001|2-Sided|95.0|29.701|85.546|||Mixed Models Analysis|||ΔVt|
1610985|NCT02533505|2959463|Superiority||Mean Difference (Final Values)|0.016||||0.113|2-Sided|95.0|-0.004|0.036|||Mixed Models Analysis|||ΔTi/Ttot|
1610986|NCT02533505|2959464|Superiority||Mean Difference (Final Values)|0.237||||0.484|2-Sided|95.0|-0.439|0.913|||Mixed Models Analysis|||ΔRR|
1610987|NCT02533505|2959465|Superiority||Mean Difference (Final Values)|0.242||||0.333|2-Sided|95.0|-0.255|0.738|||Mixed Models Analysis|||ΔSaO2|
1610988|NCT02533505|2959466|Superiority||Mean Difference (Final Values)|10.245||||0.011|2-Sided|95.0|2.469|18.021|||Mixed Models Analysis|||ΔVCO2|
1610989|NCT02533505|2959467|Superiority||Mean Difference (Final Values)|-0.204||||0.106|2-Sided|95.0|-0.454|0.045|||Mixed Models Analysis||||
1610990|NCT02533505|2959468|Superiority||Mean Difference (Final Values)|23.315||||0.021|2-Sided|95.0|3.723|42.907|||Mixed Models Analysis|||ΔVT/Ti|
1610991|NCT02533505|2959469|Superiority||Mean Difference (Final Values)|0.28|||<|0.001|2-Sided|95.0|0.218|0.342|||Mixed Models Analysis|||ΔIC|
1610992|NCT02533505|2959469|Superiority||Mean Difference (Final Values)|0.312|||<|0.001|2-Sided|95.0|0.236|0.388|||Mixed Models Analysis|||ΔFVC|
1610993|NCT02533505|2959469|Superiority||Mean Difference (Final Values)|0.191|||<|0.001|2-Sided|95.0|0.15|0.233|||Mixed Models Analysis|||ΔFEV1|
1610994|NCT02533505|2959470|Superiority||Mean Difference (Final Values)|0.35||||0.609|2-Sided|95.0|-1.018|1.719|||Mixed Models Analysis|||ΔHR|
1610995|NCT02533505|2959471|Superiority||Mean Difference (Final Values)|0.087||||0.111|2-Sided|95.0|-0.021|0.196|||Mixed Models Analysis||||
1610996|NCT02533505|2959472|Superiority||Mean Difference (Final Values)|10.114||||0.007|2-Sided|95.0|2.943|17.286||All p-values ≤ 0.05 after rounding will be considered statistically significant.|Mixed Models Analysis||||
1610997|NCT02533466|2959473|Non-Inferiority or Equivalence|Equivalent analyses was executed using scale transformation or non-parametric methods|Mean Difference (Final Values)|-0.08||||0.9121|2-Sided|95.0|-1.6|1.4||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.||
1610998|NCT02533466|2959474|Non-Inferiority or Equivalence|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|0.34||||0.7829|2-Sided|95.0|-2.2|2.8||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.||
1610999|NCT02533466|2959475|Non-Inferiority or Equivalence|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Net)|0.09||||0.3939|2-Sided|95.0|-0.1|0.3||P value obtained from the ANCOVA analysis.|ANCOVA||||
1611000|NCT02533466|2959476|Non-Inferiority or Equivalence|Equivalent analyses was executed using scale transformation or non-parametric methods.|Median Difference (Final Values)|0.21||||0.4611|2-Sided|95.0|-0.4|0.8||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.||
1611001|NCT02533466|2959477|Non-Inferiority or Equivalence|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|-2.3||||0.408|2-Sided|95.0|-7.9|3.3||P value obtained from the ANCOVA analysis.|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product||
1611002|NCT02533466|2959478|Non-Inferiority or Equivalence|Equivalent analyses was executed using scale transformation or non-parametric methods.|Mean Difference (Final Values)|-1.4||||0.6061|2-Sided|95.0|-6.8|4.1||P value obtained from the ANCOVA analysis|ANCOVA||Difference and 95 % CI obtained from the ANCOVA analysis. Difference was calculated as reference product minus test product.||
1611003|NCT02533466|2959479|Non-Inferiority or Equivalence|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-1.83||||0.0654|2-Sided|95.0|-3.0|0.0||P-value is calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test.||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product"||
1611004|NCT02533466|2959480|Non-Inferiority or Equivalence|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-1.5||||0.068|2-Sided|95.0|-2.7|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."||
1611005|NCT02533466|2959481|Non-Inferiority or Equivalence|Equivalent analyses was executed using scale transformation or non-parametric methods|Median Difference (Final Values)|-0.92||||0.069|2-Sided|95.0|-1.8|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum Test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."||
1611006|NCT02533466|2959482|Non-Inferiority or Equivalence|Equivalent analyses was executed using scale transformation or non-parametric methods.|Median Difference (Final Values)|-0.08||||0.2673|2-Sided|95.0|-1.0|0.0||P-value was calculated from Wilcoxon Rank Sum test.|Wilcoxon Rank Sum test||"Median difference and 95% CI intervals were calculated from the Hodges Lehnmann estimate.~Difference was calculated as reference product minus test product."||
1611007|NCT02533063|2959541|Superiority|||||||0.483|||||||ANOVA||||
1611008|NCT02533063|2959544|Superiority|||||||0.06|||||||ANOVA||||
1611009|NCT02533063|2959545|Superiority|||||||0.678|||||||ANOVA||||
1611010|NCT02533063|2959546|Superiority|||||||0.45|||||||ANOVA||||
1611011|NCT02533063|2959547|Superiority|||||||0.151|||||||ANOVA||||
1611012|NCT02533063|2959548|Superiority|||||||0.501|||||||ANOVA||||
1611013|NCT02533063|2959549|Superiority|||||||0.217|||||||ANOVA||||
1611014|NCT02532998|2959561|Superiority or Other||Treatment differences|3.409|||||2-Sided|90.0|2.946|3.872||||||Statistical analysis of urinary sodium/potassium ratio between Treatment A and Treatment B.|
1611015|NCT02532998|2959576|Superiority or Other||Treatment differences|-1.258|||||2-Sided|90.0|-1.721|0.7945||||||Statistical analysis of urinary sodium/potassium ratio between Treatment C and Treatment D.|
1611016|NCT02532855|2959581|Superiority||Difference in the LSM (Sit. - Dap.)|3.5|||||2-Sided|95.0|-1.2|8.3|||||||
1611017|NCT02532855|2959582|Other|The percentage of participants was estimated using standard multiple imputation techniques from LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.|Difference in % (Sit. - Dap.)|15.5|||||2-Sided|95.0|7.7|23.2|||||||
1611018|NCT02532855|2959583|Superiority||Difference in the LSM (Sit. - Dap.)|0.6|||||2-Sided|95.0|-0.1|1.3|||||||
1611019|NCT02532855|2959584|Superiority||Difference in the LSM (Sit. - Dap.)|4.9|||||2-Sided|95.0|-12.2|22.0|||||||
1611020|NCT02532855|2959585|Superiority||Difference in the LSM (Sit. - Dap.)|-4.4|||||2-Sided|95.0|-10.1|1.4|||||||
1611021|NCT02532855|2959586|Superiority||Difference in the LSM (Sit. - Dap.)|-3.4|||||2-Sided|95.0|-12.1|5.3|||||||
1611022|NCT02532855|2959587|Superiority||Difference in LSM (Sit. - Dap.)|-5.7||||0.138|2-Sided|95.0|-13.3|1.8|||LDA|LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.|||
1611023|NCT02532855|2959588|Other||Difference in % (Sit. - Dap.)|0.0|||||2-Sided|95.0|-3.0|3.0|||||||
1611024|NCT02532855|2959589|Other||Difference in % (Sit. - Dap.)|-2.8|||||2-Sided|95.0|-10.7|5.1|||||||
1611025|NCT02532855|2959590|Superiority||Difference in LSM (Sit. - Dap.)|-0.15||||0.006|2-Sided|95.0|-0.26|-0.04|||Longitudinal data analysis|LDA model including terms for treatment, time, background AHA, the interaction of time and background AHA, and the interaction of time by treatment.|||
1611026|NCT02532855|2959590|Non-Inferiority|For the primary hypothesis, sitagliptin will be considered non-inferior to dapagliflozin if the upper bound of the two-sided 95% confidence interval (CI) of the between-group difference in least squares mean change from baseline in A1C (sitagliptin minus dapagliflozin) is less than 0.3% (the non-inferiority margin). Longitudinal data analysis (LDA), Antihyperglycemic agent (AHA), Least squares means (LSM)|Difference in LSM (Sit. - Dap.)|-0.15|||||2-Sided|95.0|-0.26|-0.04|||||||
1611027|NCT02532764|2959591|Superiority||Difference vs placebo|3.21|Standard Error of the Mean|3.89||0.4224|2-Sided|95.0|-5.13|11.55||P-values are presented for Day 33|Mixed Models Analysis||||
1611028|NCT02532764|2959591|Superiority||Difference vs placebo|3.5|Standard Error of the Mean|3.69||0.358|2-Sided|95.0|-4.4|11.41||P-values are presented for Day 33|Mixed Models Analysis||||
1611029|NCT02532764|2959591|Superiority||Difference vs placebo|7.99|Standard Error of the Mean|3.91||0.0601|2-Sided|95.0|-0.39|16.37||P-values are presented for Day 33|Mixed Models Analysis||||
1611030|NCT02532764|2959591|Superiority||Difference vs placebo|10.19|Standard Error of the Mean|4.22||0.0301|2-Sided|95.0|1.13|19.25||P-values are presented for Day 33|Mixed Models Analysis||||
1611031|NCT02532764|2959593|Superiority||difference vs placebo|-0.51|Standard Error of the Mean|3.35||0.8813|2-Sided|95.0|-7.41|6.39||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.|
1611032|NCT02532764|2959593|Superiority||difference vs placebo|0.53|Standard Error of the Mean|3.18||0.8688|2-Sided|95.0|-6.01|7.07||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.|
1611033|NCT02532764|2959593|Superiority||difference vs placebo|2.75|Standard Error of the Mean|3.18||0.3943|2-Sided|95.0|-3.79|9.29||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariates.|
1611034|NCT02532764|2959593|Superiority||difference vs placebo|4.24|Standard Error of the Mean|3.18||0.1938|2-Sided|95.0|-2.3|10.79||P-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline ppFEV1 as outcome variable and including treatment, baseline ppFEV1 value, time and interaction between time and treatment as covariate|
1611035|NCT02532764|2959595|Superiority||Difference vs placebo|10.84|Standard Error of the Mean|9.01||0.2485|2-Sided|95.0|-8.47|30.16||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.|
1611036|NCT02532764|2959595|Superiority||Difference vs placebo|20.16|Standard Error of the Mean|8.62||0.0346|2-Sided|95.0|1.68|38.64||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.|
1611037|NCT02532764|2959595|Superiority||Difference vs placebo|27.3|Standard Error of the Mean|9.17||0.01|2-Sided|95.0|7.64|46.96||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.|
1611038|NCT02532764|2959595|Superiority||Difference vs placebo|23.17|Standard Error of the Mean|9.73||0.0321|2-Sided|95.0|2.29|44.04||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.|
1611039|NCT02532764|2959597|Superiority||difference vs placebo|3.46|Standard Error of the Mean|6.87||0.6193|2-Sided|95.0|-10.69|17.6||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.|
1611040|NCT02532764|2959597|Superiority||difference vs placebo|14.24|Standard Error of the Mean|6.6||0.0408|2-Sided|95.0|0.64|27.83||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.|
1611041|NCT02532764|2959597|Superiority||difference vs placebo|19.13|Standard Error of the Mean|6.56||0.0074|2-Sided|95.0|5.62|32.64||p-values are presented for Day 33|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.|
1611042|NCT02532764|2959597|Superiority||Difference vs placebo|12.91|Standard Error of the Mean|6.53||0.0592|2-Sided|95.0|-0.54|26.35||p-values are presented for Day 33.|Mixed Models Analysis|||A mixed-model analysis was performed with repeated time measures on the change from baseline CFQ-R RSS as outcome variable and including treatment, baseline CFQ-R RSS value, time and interaction between time and treatment as covariates.|
1611043|NCT02532543|2959613|Superiority|||||||0.756|||||||ANOVA|||Comparison between each arm/group of change in distal soft tissue height|
1611044|NCT02532543|2959613|Superiority|||||||0.243|||||||ANOVA|||Comparison between each arm/group of change in mesial soft tissue height|
1611045|NCT02532543|2959613|Superiority|||||||0.823|||||||ANOVA|||Comparison between each arm/group of change in mid palatal soft tissue height|
1611046|NCT02532543|2959613|Superiority|||||||0.353|||||||ANOVA|||Comparison between each arm/group of change in mid buccal soft tissue height|
1611047|NCT02532543|2959614|Superiority|||||||0.917|||||||ANOVA|||Comparison between each arm/group at 4 mm from the height of the bone crest|
1611127|NCT02530294|2959898|Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1611048|NCT02532543|2959614|Superiority|||||||0.492|||||||ANOVA|||Comparison between each arm/group at 2 mm from the height of the bone crest|
1611049|NCT02532543|2959615|Superiority|||||||0.613|||||||ANOVA||||
1611050|NCT02532543|2959616|Superiority|||||||0.729|||||||ANOVA|||Comparison between each arm/group of change in distal bone height|
1611051|NCT02532543|2959616|Superiority|||||||0.44|||||||ANOVA|||Comparison between each arm/group of change in mesial bone height|
1611052|NCT02532543|2959616|Superiority|||||||0.999|||||||ANOVA|||Comparison between each arm/group of change in mid palatal bone height|
1611053|NCT02532543|2959616|Superiority|||||||0.718|||||||ANOVA|||Comparison between each arm/group of change in mid buccal bone height|
1611054|NCT02532543|2959617|Superiority|||||||0.853|||||||ANOVA|||Comparison between each arm/group at 4 mm from the height of the bone crest|
1611055|NCT02532543|2959617|Superiority|||||||0.718|||||||ANOVA|||Comparison between each arm/group at 2 mm from the height of the bone crest|
1611056|NCT02532543|2959618|Superiority|||||||0.863|||||||ANOVA||||
1611057|NCT02532179|2959658|Superiority||Mean Ratio|6.55|||<|0.001|2-Sided|95.0|3.87|11.06||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis||||
1611058|NCT02532179|2959659|Superiority||Mean Ratio|3.82|||<|0.001|2-Sided|95.0|2.77|5.25||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis||||
1611059|NCT02532179|2959660|Superiority||Mean Ratio|3.0|||<|0.001|2-Sided|95.0|2.09|4.29||Null hypothesis: there is no difference in immune modulation over time|Mixed Models Analysis||||
1611060|NCT02531646|2959748|Superiority or Other|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided||||
1611061|NCT02531646|2959750|Superiority or Other|||||||0.007||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided||||
1611062|NCT02531646|2959751|Superiority or Other|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician. They were rounded to fit four digits."|t-test, 1 sided||||
1611063|NCT02531646|2959752|Superiority or Other|||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|t-test, 1 sided||||
1611064|NCT02531646|2959753|Non-Inferiority or Equivalence|Equivalence interval (-0.25, 0.25)||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|Equivalence test||||
1611065|NCT02531646|2959754|Non-Inferiority or Equivalence|Equivalence interval (-0.25, 0.25)||||||0||||||"Level of significance (alpha) = 0.05~All p-values were calculated (and verified) by our statistician.They were rounded to fit four digits."|Equivalence test||||
1611066|NCT02531438|2959848|Non-Inferiority|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||2-Sided|95.0|-1.7|6.8|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.||
1611067|NCT02531438|2959849|Non-Inferiority|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||2-Sided|95.0|-2.4|7.4|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.||
1611068|NCT02531438|2959850|Non-Inferiority|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-1.6|||||2-Sided|95.0|-7.1|3.8|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus moxifloxacin.||
1611069|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|18.38|||||2-Sided|95.0|9.82|34.41||||||Serotype 33F (non-Prevnar serotype)|
1611070|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.98|||||2-Sided|95.0|0.61|1.57||||||Serotype 23F|
1611071|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|89.87|||||2-Sided|95.0|67.02|120.51||||||Serotype 22F (non-Prevnar serotype)|
1611072|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|1.08|||||2-Sided|95.0|0.81|1.44||||||Serotype 19F|
1611073|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.88|||||2-Sided|95.0|0.63|1.22||||||Serotype 19A|
1611074|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.79|||||2-Sided|95.0|0.55|1.16||||||Serotype 18C|
1611075|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.93|||||2-Sided|95.0|0.63|1.37||||||Serotype 14|
1611076|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.98|||||2-Sided|95.0|0.64|1.49||||||Serotype 9V|
1611077|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.97|||||2-Sided|95.0|0.71|1.31||||||Serotype 7F|
1611078|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.8|||||2-Sided|95.0|0.42|1.5||||||Serotype 6B|
1611079|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.54|||||2-Sided|95.0|0.31|0.92||||||Serotype 6A|
1611080|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.83|||||2-Sided|95.0|0.53|1.31||||||Serotype 5|
1611081|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|1.15|||||2-Sided|95.0|0.82|1.62||||||Serotype 4|
1611082|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|2.11|||||2-Sided|95.0|1.6|2.8||||||Serotype 3|
1611083|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.92|||||2-Sided|95.0|0.68|1.23||||||Serotype 1|
1611084|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|22.23|||||2-Sided|95.0|11.77|41.97||||||Serotype 33F (non-Prevnar serotype)|
1611085|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.91|||||2-Sided|95.0|0.56|1.47||||||Serotype 23F|
1611086|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|81.47|||||2-Sided|95.0|60.51|109.68||||||Serotype 22F (non-Prevnar serotype)|
1611087|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.83|||||2-Sided|95.0|0.62|1.11||||||Serotype 19F|
1611088|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.9|||||2-Sided|95.0|0.64|1.26||||||Serotype 19A|
1611089|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.63||||||95.0|0.43|0.92||||||Serotype 18C|
1611090|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.86|||||2-Sided|95.0|0.58|1.27||||||Serotype 14|
1611091|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|1.14|||||2-Sided|95.0|0.74|1.75||||||Serotype 9V|
1611092|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.75|||||2-Sided|95.0|0.55|1.03||||||Serotype 7F|
1611093|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|1.11|||||2-Sided|95.0|0.58|2.1||||||Serotype 6B|
1611094|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.5||||||95.0|0.29|0.86||||||Serotype 6A|
1611095|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.95|||||2-Sided|95.0|0.59|1.51||||||Serotype 5|
1611096|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|1.28|||||2-Sided|95.0|0.91|1.81||||||Serotype 4|
1611097|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|1.77|||||2-Sided|95.0|1.33|2.35||||||Serotype 3|
1611098|NCT02531373|2959858|Equivalence|2-sample t-test|Risk Ratio (RR)|0.82|||||2-Sided|95.0|0.61|1.1||||||Serotype 1|
1611099|NCT02531373|2959859|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|5.8||||0.298|2-Sided|95.0|-5.8|18.2|||Miettinen and Nurminen method||||
1611100|NCT02531373|2959859|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|3.7||||0.529|2-Sided|95.0|-8.7|16.4|||Miettinen and Nurminen method||||
1611101|NCT02531373|2959859|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|-2.5||||0.711|2-Sided|95.0|-16.4|11.2|||Miettinen and Nurminen method||||
1611102|NCT02531373|2959859|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|-0.5||||0.943|2-Sided|95.0|-14.0|12.9|||Miettinen and Nurminen method||||
1611103|NCT02531373|2959860|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|23.1||||0.011|2-Sided|95.0|5.4|39.6|||Miettinen and Nurminen method||||
1611104|NCT02531373|2959860|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|1.1||||0.908|2-Sided|95.0|-17.7|19.9|||Miettinen and Nurminen method||||
1611105|NCT02531373|2959860|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|22.3||||0.016|2-Sided|95.0|4.3|39.1|||Miettinen and Nurminen method||||
1611106|NCT02531373|2959860|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|20.3||||0.029|2-Sided|95.0|2.1|37.3|||Miettinen and Nurminen method||||
1611107|NCT02531373|2959861|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||2-Sided|95.0|-6.9|6.9|||||||
1611108|NCT02531373|2959861|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||2-Sided|95.0|-6.9|7.1|||||||
1611109|NCT02531373|2959861|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||2-Sided|95.0|-6.9|7.2|||||||
1611110|NCT02531373|2959861|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|0.0|||||2-Sided|95.0|-6.9|7.2|||||||
1611111|NCT02531373|2959862|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|-1.9|||||2-Sided|95.0|-10.2|5.1|||||||
1611112|NCT02531373|2959862|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|-3.9|||||2-Sided|95.0|-13.3|3.2|||||||
1611113|NCT02531373|2959862|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|-6.0|||||2-Sided|95.0|-16.3|1.2|||||||
1611114|NCT02531373|2959862|Equivalence|Miettinen and Nurminen method|Risk Difference (RD)|-4.0|||||2-Sided|95.0|-13.5|3.1|||||||
1611115|NCT02531321|2959866|Other|Unpaired t test with Welch’s correction|||||<|0.05|||||||t-test, 2 sided||||
1611116|NCT02531035|2959868|Superiority||Least squares mean difference|-12.32|||<|0.001|2-Sided|95.0|-18.17|-6.48|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (<25 kg/m2, >=25 kg/m2), randomization stratum of Week -2 A1C (<=9.0%, >9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.|
1611117|NCT02531035|2959869|Superiority||Least Squares Mean Difference|-3.5|||=|0|2-Sided|95.0|-5.7|-1.3|||MMRM|||Testing according to the hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (<25 kg/m2, >=25 kg/m2), randomization stratum of Week -2 A1C (<=9.0%, >9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by- time interaction as fixed categorical effects, and Baseline SBP-by-time interaction as a covariate.|
1611118|NCT02531035|2959870|Superiority||Least squares mean difference|-2.98|||<|0.001|2-Sided|95.0|-3.31|-2.66|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (<25 kg/m^2, >=25 kg/m^2), randomization stratum of Week -2 A1C (<=9%, >9%), randomization stratum of Use of CSII at Screening (Yes, No), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline weight-by-time interaction as a covariate.|
1611119|NCT02531035|2959871|Superiority||Least Squares Mean Difference|-0.46|||<|0.001|2-Sided|95.0|-0.54|-0.38|||MMRM|||Testing according to hierarchical procedure. Post-Baseline LS means and p-values were obtained from MMRM model with treatment, randomization stratum of BMI at Screening (<25 kg/m^2, >=25 kg/m^2), randomization stratum of Week -2 A1C (<=9.0%, >9.0%), randomization stratum of use of CSII at Screening (yes, no), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.|
1611120|NCT02531035|2959872|Superiority||Percentage difference|13.4|||<|0.001|2-Sided|95.0|8.97|17.81||P-values from Cochran-Mantel-Haenszel test stratified by different levels of stratification factors of BMI at Screening(<25 kg/m^2,>=25 kg/m^2),Week -2 A1C(<=9.0%, >9.0%),and using continuous subcutaneous insulin infusion(CSII) at Screening(yes,no).|Cochran-Mantel-Haenszel||||
1611121|NCT02530450|2959892|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Testing the change between two time points within each group using Wilcoxon signed rank test.|
1611122|NCT02530385|2959893|Superiority|||||||0.32|||||||Mixed Models Analysis||||
1611123|NCT02530385|2959894|Superiority|||||||0.9|||||||Mixed Models Analysis||||
1611124|NCT02530385|2959895|Superiority|||||||0.93|||||||Mixed Models Analysis||||
1611128|NCT02530294|2959899|Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1611129|NCT02530294|2959900|Other||||||<|0.001|||||||ANCOVA|Ranked ANCOVA|||
1611130|NCT02530294|2959901|Other||||||<|0.001|||||||ANCOVA|Ranked ANCOVA|||
1611131|NCT02530294|2959902|Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1611132|NCT02530281|2959903|Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1611133|NCT02530281|2959904|Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1611134|NCT02530281|2959905|Other||||||=|0|||||||ANCOVA|Ranked ANCOVA|||
1611135|NCT02530281|2959906|Other||||||=|0|||||||ANCOVA|Ranked ANCOVA|||
1611136|NCT02530281|2959907|Other||||||=|0|||||||ANCOVA|Ranked ANCOVA|||
1611137|NCT02530281|2959908|Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1611138|NCT02529137|2959941|Non-Inferiority|the non-inferiority margin was set at 4%|difference|0.4|||||2-Sided|95.0|-0.3|1.01|||||||
1611139|NCT02528643|2959949|Superiority||Hazard Ratio (HR)|0.959||||0.586|2-Sided|95.0|0.684|1.345||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model. Hazard ratio < 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Unstratified Analysis. The null hypothesis was stated as: PFS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: PFS is prolonged in enzalutamide arm. The null hypothesis was tested using a one-sided log-rank test at the 0.10 level.|
1611140|NCT02528643|2959949|Superiority||Hazard Ratio (HR)|1.039||||0.396|2-Sided|95.0|0.732|1.474||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model, stratified by ECOG performance status and region. Hazard ratio < 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Stratified Analysis. The null hypothesis was stated as: PFS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: PFS is prolonged in enzalutamide arm. The null hypothesis was tested using a stratified one-sided log-rank test at the 0.10 level. Stratification factors were ECOG performance status and region from eCRF.|
1611141|NCT02528643|2959954|Superiority||Hazard Ratio (HR)|1.142||||0.252|2-Sided|95.0|0.773|1.688||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model. Hazard ratio < 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Unstratified Analysis. The null hypothesis was stated as: OS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: OS is prolonged in enzalutamide arm. The null hypothesis was tested using a one-sided log-rank test at the 0.10 level.|
1611142|NCT02528643|2959954|Superiority||Hazard Ratio (HR)|1.146||||0.248|2-Sided|95.0|0.774|1.696||One-sided p-value.|Log Rank||Calculated using a Cox proportional hazard model, stratified by geographic region and ECOG performance status. Hazard ratio < 1 indicated a reduction in hazard rate in favor of enzalutamide group.|Stratified Analysis. The null hypothesis was stated as: OS distributions of the 2 arms are equivalent. The alternative hypothesis was stated as: OS is prolonged in enzalutamide arm. The null hypothesis was tested using a stratified one-sided log-rank test at the 0.10 level. Stratification factors were ECOG performance status and region from eCRF.|
1611143|NCT02528305|2959982|Superiority or Other|||||||0.009|||||||ANOVA||||
1611144|NCT02528305|2959983|Superiority or Other|||||||0.513|||||||ANOVA||||
1611145|NCT02528305|2959984|Superiority or Other|||||||0.793|||||||ANOVA||||
1611146|NCT02528305|2959985|Superiority or Other|||||||0.005|||||||ANOVA||||
1611147|NCT02528305|2959986|Superiority or Other||||||<|0.001|||||||ANOVA||||
1611148|NCT02528305|2959987|Superiority or Other|||||||0.31|||||||ANOVA||||
1611149|NCT02528305|2959988|Superiority or Other|||||||0.745|||||||ANOVA|For the analysis of Health Perception|||
1611150|NCT02528305|2959988|Superiority or Other|||||||0.366|||||||ANOVA|For the analysis of Energy/Vitality|||
1611151|NCT02528305|2959988|Superiority or Other|||||||0.841|||||||ANOVA|For the analysis of Mental Role Limitation|||
1611152|NCT02528305|2959988|Superiority or Other|||||||0.114|||||||ANOVA|For the analysis of Physical Role Limitation|||
1611153|NCT02528305|2959988|Superiority or Other|||||||0.085|||||||ANOVA|For the analysis of Change in Health|||
1611154|NCT02528305|2959988|Superiority or Other|||||||0.145|||||||ANOVA|For the analysis of Pain|||
1611155|NCT02528305|2959988|Superiority or Other|||||||0.246|||||||ANOVA|For the analysis of Mental Health|||
1611156|NCT02528305|2959988|Superiority or Other|||||||0.566|||||||ANOVA|For the analysis of Social Function|||
1611157|NCT02528305|2959988|Superiority or Other|||||||0.099|||||||ANOVA|For the analysis of Physical Function|||
1611158|NCT02528305|2959989|Superiority or Other|||||||0.028|||||||ANOVA|For the analysis of diastolic blood pressure|||
1611159|NCT02528305|2959989|Superiority or Other|||||||0.771|||||||ANOVA|For the analysis of systolic blood pressure|||
1611160|NCT02528305|2959990|Superiority or Other|||||||0.101|||||||ANOVA|For the analysis of Trunk fat|||
1611161|NCT02528305|2959990|Superiority or Other|||||||0.092|||||||ANOVA|For the analysis of Total body fat|||
1611162|NCT02528305|2959991|Superiority|||||||0.023|||||||ANOVA||||
1611163|NCT02528305|2959992|Superiority or Other|||||||0.303|||||||ANOVA||||
1611164|NCT02528305|2959993|Superiority or Other|||||||0.174|||||||ANOVA||||
1611165|NCT02528305|2959994|Superiority or Other|||||||0.474|||||||ANOVA||||
1611166|NCT02528253|2960012|Superiority||LS Mean Difference|3.93|Standard Error of the Mean|2.19||0.0743|2-Sided|95.0|-0.39|8.24|||ANCOVA|||TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611167|NCT02528253|2960012|Superiority||LS Mean Difference|3.54|Standard Error of the Mean|2.27||0.1197|2-Sided|95.0|-0.92|8.0|||ANCOVA|||TSQM Global Satisfaction; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611168|NCT02528253|2960012|Superiority||LS Mean Difference|2.1|Standard Error of the Mean|1.92||0.2758|2-Sided|95.0|-1.68|5.87|||ANCOVA|||TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611217|NCT02528253|2960021|Superiority||LS Mean Ratio|1.02|Standard Error of the Mean|0.23||0.9351|2-Sided|95.0|0.65|1.6|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611169|NCT02528253|2960012|Superiority||LS Mean Difference|0.3|Standard Error of the Mean|1.99||0.8795|2-Sided|95.0|-3.61|4.21|||ANCOVA|||TSQM Convenience; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611170|NCT02528253|2960012|Superiority||LS Mean Difference|13.17|Standard Error of the Mean|5.6||0.0265|2-Sided|95.0|1.66|24.68|||ANCOVA|||TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611171|NCT02528253|2960012|Superiority||LS Mean Difference|2.71|Standard Error of the Mean|6.95||0.6991|2-Sided|95.0|-11.56|16.99|||ANCOVA|||TSQM Side Effects; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611172|NCT02528253|2960012|Superiority||LS Mean Difference|1.3|Standard Error of the Mean|2.53||0.6084|2-Sided|95.0|-3.68|6.27|||ANCOVA|||TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611173|NCT02528253|2960012|Superiority||LS Mean Difference|1.45|Standard Error of the Mean|2.62||0.5806|2-Sided|95.0|-3.7|6.6|||ANCOVA|||TSQM Effectiveness; Week 56: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611174|NCT02528253|2960012|Superiority||LS Mean Difference|1.52|Standard Error of the Mean|1.72||0.3775|2-Sided|95.0|-1.86|4.9|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611175|NCT02528253|2960012|Superiority||LS Mean Difference|3.2|Standard Error of the Mean|1.73||0.0644|2-Sided|95.0|-0.19|6.59|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611176|NCT02528253|2960012|Superiority||LS Mean Difference|2.22|Standard Error of the Mean|1.75||0.2038|2-Sided|95.0|-1.21|5.65|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611177|NCT02528253|2960012|Superiority||LS Mean Difference|3.74|Standard Error of the Mean|1.86||0.0449|2-Sided|95.0|0.09|7.39|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611178|NCT02528253|2960012|Superiority||LS Mean Difference|5.42|Standard Error of the Mean|1.86||0.0037|2-Sided|95.0|1.77|9.08|||ANCOVA|||TSQM Global Satisfaction; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611179|NCT02528253|2960012|Superiority||LS Mean Difference|1.74|Standard Error of the Mean|1.27||0.173|2-Sided|95.0|-0.76|4.24|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611180|NCT02528253|2960012|Superiority||LS Mean Difference|1.05|Standard Error of the Mean|1.28||0.4124|2-Sided|95.0|-1.46|3.56|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611181|NCT02528253|2960012|Superiority||LS Mean Difference|1.52|Standard Error of the Mean|1.3||0.2419|2-Sided|95.0|-1.03|4.06|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611182|NCT02528253|2960012|Superiority||LS Mean Difference|3.26|Standard Error of the Mean|1.38||0.0187|2-Sided|95.0|0.54|5.97|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611183|NCT02528253|2960012|Superiority||LS Mean Difference|2.57|Standard Error of the Mean|1.38||0.0627|2-Sided|95.0|-0.14|5.27|||ANCOVA|||TSQM Convenience; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611184|NCT02528253|2960012|Superiority||LS Mean Difference|8.67|Standard Error of the Mean|3.9||0.0276|2-Sided|95.0|0.97|16.38|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611185|NCT02528253|2960012|Superiority||LS Mean Difference|8.42|Standard Error of the Mean|3.89||0.0319|2-Sided|95.0|0.74|16.11|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611186|NCT02528253|2960012|Superiority||LS Mean Difference|3.88|Standard Error of the Mean|4.29||0.3675|2-Sided|95.0|-4.6|12.36|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611187|NCT02528253|2960012|Superiority||LS Mean Difference|12.55|Standard Error of the Mean|4.96||0.0124|2-Sided|95.0|2.76|22.35|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611188|NCT02528253|2960012|Superiority||LS Mean Difference|12.3|Standard Error of the Mean|4.96||0.0143|2-Sided|95.0|2.5|22.11|||ANCOVA|||TSQM Side Effects; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611189|NCT02528253|2960012|Superiority||LS Mean Difference|1.49|Standard Error of the Mean|1.86||0.4235|2-Sided|95.0|-2.16|5.14|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611190|NCT02528253|2960012|Superiority||LS Mean Difference|2.31|Standard Error of the Mean|1.87||0.2176|2-Sided|95.0|-1.36|5.97|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611191|NCT02528253|2960012|Superiority||LS Mean Difference|4.72|Standard Error of the Mean|1.89||0.0125|2-Sided|95.0|1.02|8.42|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1612418|NCT02527161|2960183|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in KOOS Sports score from preoperative to 2 years.|
1611192|NCT02528253|2960012|Superiority||LS Mean Difference|6.21|Standard Error of the Mean|2.01||0.0021|2-Sided|95.0|2.26|10.15|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611193|NCT02528253|2960012|Superiority||LS Mean Difference|7.02|Standard Error of the Mean|2.01||0.0005|2-Sided|95.0|3.07|10.97|||ANCOVA|||TSQM Effectiveness; Week 16: p-value was computed using ANCOVA with covariates of baseline average LBPI score, treatment, and study site as a random effect.|
1611194|NCT02528253|2960021|Superiority||LS Mean Ratio|1.05|Standard Error of the Mean|0.33||0.8826|2-Sided|95.0|0.56|1.95|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611195|NCT02528253|2960021|Superiority||LS Mean Ratio|1.19|Standard Error of the Mean|0.38||0.5914|2-Sided|95.0|0.64|2.21|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611196|NCT02528253|2960021|Superiority||LS Mean Ratio|0.94|Standard Error of the Mean|0.3||0.8359|2-Sided|95.0|0.5|1.75|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611197|NCT02528253|2960021|Superiority||LS Mean Ratio|0.98|Standard Error of the Mean|0.34||0.9564|2-Sided|95.0|0.5|1.94|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611198|NCT02528253|2960021|Superiority||LS Mean Ratio|1.11|Standard Error of the Mean|0.39||0.7635|2-Sided|95.0|0.56|2.2|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611199|NCT02528253|2960021|Superiority||LS Mean Ratio|0.92|Standard Error of the Mean|0.26||0.7673|2-Sided|95.0|0.52|1.61|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611200|NCT02528253|2960021|Superiority||LS Mean Ratio|1.02|Standard Error of the Mean|0.29||0.9486|2-Sided|95.0|0.58|1.79|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611201|NCT02528253|2960021|Superiority||LS Mean Ratio|0.86|Standard Error of the Mean|0.25||0.5925|2-Sided|95.0|0.49|1.5|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611202|NCT02528253|2960021|Superiority||LS Mean Ratio|0.79|Standard Error of the Mean|0.25||0.4475|2-Sided|95.0|0.43|1.46|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611203|NCT02528253|2960021|Superiority||LS Mean Ratio|0.87|Standard Error of the Mean|0.27||0.6673|2-Sided|95.0|0.47|1.62|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611204|NCT02528253|2960021|Superiority||LS Mean Ratio|1.07|Standard Error of the Mean|0.28||0.8049|2-Sided|95.0|0.64|1.77|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611205|NCT02528253|2960021|Superiority||LS Mean Ratio|1.11|Standard Error of the Mean|0.29||0.6821|2-Sided|95.0|0.67|1.85|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611206|NCT02528253|2960021|Superiority||LS Mean Ratio|0.86|Standard Error of the Mean|0.22||0.5629|2-Sided|95.0|0.52|1.43|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611207|NCT02528253|2960021|Superiority||LS Mean Ratio|0.92|Standard Error of the Mean|0.26||0.7614|2-Sided|95.0|0.53|1.6|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611208|NCT02528253|2960021|Superiority||LS Mean Ratio|0.96|Standard Error of the Mean|0.27||0.8772|2-Sided|95.0|0.55|1.67|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611209|NCT02528253|2960021|Superiority||LS Mean Ratio|1.0|Standard Error of the Mean|0.23||0.992|2-Sided|95.0|0.63|1.57|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611210|NCT02528253|2960021|Superiority||LS Mean Ratio|1.06|Standard Error of the Mean|0.25||0.7949|2-Sided|95.0|0.67|1.67|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611211|NCT02528253|2960021|Superiority||LS Mean Ratio|0.89|Standard Error of the Mean|0.21||0.6103|2-Sided|95.0|0.56|1.4|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611212|NCT02528253|2960021|Superiority||LS Mean Ratio|0.89|Standard Error of the Mean|0.22||0.6345|2-Sided|95.0|0.54|1.46|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611213|NCT02528253|2960021|Superiority||LS Mean Ratio|0.94|Standard Error of the Mean|0.24||0.8192|2-Sided|95.0|0.57|1.55|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611214|NCT02528253|2960021|Superiority||LS Mean Ratio|1.05|Standard Error of the Mean|0.22||0.8031|2-Sided|95.0|0.7|1.59|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611215|NCT02528253|2960021|Superiority||LS Mean Ratio|1.14|Standard Error of the Mean|0.24||0.537|2-Sided|95.0|0.75|1.72|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611216|NCT02528253|2960021|Superiority||LS Mean Ratio|0.97|Standard Error of the Mean|0.2||0.8731|2-Sided|95.0|0.64|1.46|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1612419|NCT02527161|2960183|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in KOOS ADL score from preoperative to 2 years.|
1611218|NCT02528253|2960021|Superiority||LS Mean Ratio|1.1|Standard Error of the Mean|0.25||0.6764|2-Sided|95.0|0.7|1.73|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611219|NCT02528253|2960023|Superiority||LS Mean Ratio|0.86|Standard Error of the Mean|0.12||0.2844|2-Sided|95.0|0.66|1.13|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611220|NCT02528253|2960023|Superiority||LS Mean Ratio|0.93|Standard Error of the Mean|0.13||0.6148|2-Sided|95.0|0.71|1.22|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611221|NCT02528253|2960023|Superiority||LS Mean Ratio|0.91|Standard Error of the Mean|0.13||0.5092|2-Sided|95.0|0.69|1.2|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611222|NCT02528253|2960023|Superiority||LS Mean Ratio|0.96|Standard Error of the Mean|0.14||0.7938|2-Sided|95.0|0.73|1.27|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611223|NCT02528253|2960023|Superiority||LS Mean Ratio|0.91|Standard Error of the Mean|0.13||0.488|2-Sided|95.0|0.69|1.2|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611224|NCT02528253|2960023|Superiority||LS Mean Ratio|1.02|Standard Error of the Mean|0.14||0.8996|2-Sided|95.0|0.77|1.34|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611225|NCT02528253|2960023|Superiority||LS Mean Ratio|0.98|Standard Error of the Mean|0.14||0.8827|2-Sided|95.0|0.75|1.29|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611226|NCT02528253|2960023|Superiority||LS Mean Ratio|0.98|Standard Error of the Mean|0.14||0.8716|2-Sided|95.0|0.75|1.28|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611227|NCT02528253|2960023|Superiority||LS Mean Ratio|1.02|Standard Error of the Mean|0.14||0.8936|2-Sided|95.0|0.78|1.34|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611228|NCT02528253|2960023|Superiority||LS Mean Ratio|1.03|Standard Error of the Mean|0.14||0.8444|2-Sided|95.0|0.78|1.35|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611229|NCT02528253|2960023|Superiority||LS Mean Ratio|0.98|Standard Error of the Mean|0.14||0.8692|2-Sided|95.0|0.73|1.3|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611230|NCT02528253|2960023|Superiority||LS Mean Ratio|1.2|Standard Error of the Mean|0.18||0.2088|2-Sided|95.0|0.9|1.6|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611231|NCT02528253|2960023|Superiority||LS Mean Ratio|0.92||||0.551|2-Sided|95.0|0.71|1.2|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611232|NCT02528253|2960023|Superiority||LS Mean Ratio|1.13||||0.3378|2-Sided|95.0|0.88|1.47|||Negative binomial model|||Week 12: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611233|NCT02528253|2960023|Superiority||LS Mean Ratio|0.94||||0.5865|2-Sided|95.0|0.74|1.19|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611234|NCT02528253|2960023|Superiority||LS Mean Ratio|1.14||||0.267|2-Sided|95.0|0.9|1.44|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611235|NCT02528253|2960023|Superiority||LS Mean Ratio|0.96||||0.6798|2-Sided|95.0|0.77|1.18|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611236|NCT02528253|2960023|Superiority||LS Mean Ratio|1.1|Standard Error of the Mean|0.12||0.3559|2-Sided|95.0|0.89|1.36|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611237|NCT02528253|2960023|Superiority||LS Mean Ratio|1.05|Standard Error of the Mean|0.1||0.6322|2-Sided|95.0|0.86|1.27|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611238|NCT02528253|2960023|Superiority||LS Mean Ratio|1.16|Standard Error of the Mean|0.11||0.1272|2-Sided|95.0|0.96|1.41|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of Baseline average LBPI and treatment group.|
1611239|NCT02528253|2960025|Superiority||Odds Ratio (OR)|0.96||||0.7803|2-Sided|95.0|0.74|1.25|||Regression, Logistic|||Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611240|NCT02528253|2960025|Superiority||Odds Ratio (OR)|0.97||||0.7946|2-Sided|95.0|0.74|1.26|||Regression, Logistic|||Week 56: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611241|NCT02528253|2960025|Superiority||Odds Ratio (OR)|1.02||||0.88|2-Sided|95.0|0.78|1.33|||Regression, Logistic|||Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611242|NCT02528253|2960025|Superiority||Odds Ratio (OR)|0.99||||0.9383|2-Sided|95.0|0.76|1.29|||Regression, Logistic|||Week 48: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611243|NCT02528253|2960025|Superiority||Odds Ratio (OR)|1.03||||0.8389|2-Sided|95.0|0.79|1.34|||Regression, Logistic|||Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1614328|NCT02494401|2963012|Superiority|||||||0.32|||||||Wilcoxon (Mann-Whitney)||||
1611244|NCT02528253|2960025|Superiority||Odds Ratio (OR)|1.04||||0.7714|2-Sided|95.0|0.8|1.35|||Regression, Logistic|||Week 40: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611245|NCT02528253|2960025|Superiority||Odds Ratio (OR)|1.11||||0.4321|2-Sided|95.0|0.85|1.44|||Regression, Logistic|||Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611246|NCT02528253|2960025|Superiority||Odds Ratio (OR)|1.04||||0.769|2-Sided|0.769|0.8|1.35|||Regression, Logistic|||Week 32: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611247|NCT02528253|2960025|Superiority||Odds Ratio (OR)|1.08||||0.5644|2-Sided|95.0|0.83|1.4|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611248|NCT02528253|2960025|Superiority||Odds Ratio (OR)|1.03||||0.8532|2-Sided|95.0|0.79|1.33|||Regression, Logistic|||Week 24: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611249|NCT02528253|2960025|Superiority||Odds Ratio (OR)|0.94||||0.6377|2-Sided|95.0|0.71|1.23|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611250|NCT02528253|2960025|Superiority||Odds Ratio (OR)|1.04||||0.7746|2-Sided|95.0|0.79|1.36|||Regression, Logistic|||Week 16: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611251|NCT02528253|2960025|Superiority||Odds Ratio (OR)|1.01||||0.9476|2-Sided|95.0|0.78|1.31|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611252|NCT02528253|2960025|Superiority||Odds Ratio (OR)|1.04||||0.7562|2-Sided|95.0|0.8|1.35|||Regression, Logistic|||Week 12: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611253|NCT02528253|2960025|Superiority||Odds Ratio (OR)|0.89||||0.3909|2-Sided|95.0|0.69|1.16|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611254|NCT02528253|2960025|Superiority||Odds Ratio (OR)|1.08||||0.5619|2-Sided|95.0|0.84|1.39|||Regression, Logistic|||Week 8: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611255|NCT02528253|2960025|Superiority||Odds Ratio (OR)|0.84||||0.1765|2-Sided|95.0|0.65|1.08|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611256|NCT02528253|2960025|Superiority||Odds Ratio (OR)|1.13||||0.3326|2-Sided|95.0|0.88|1.46|||Regression, Logistic|||Week 4: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611257|NCT02528253|2960025|Superiority||Odds Ratio (OR)|0.93||||0.5932|2-Sided|95.0|0.73|1.2|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611258|NCT02528253|2960025|Superiority||Odds Ratio (OR)|1.12||||0.396|2-Sided|95.0|0.87|1.44|||Regression, Logistic|||Week 2: Odds ratio and 95% CI estimated from logistic regression model. Logistic regression model included baseline LBPI and treatment.|
1611259|NCT02528253|2960026|Superiority|||||||0.7142|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.|
1611260|NCT02528253|2960026|Superiority|||||||0.4724|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.|
1611261|NCT02528253|2960027|Superiority||Odds Ratio (OR)|1.06||||0.771|2-Sided|95.0|0.71|1.58|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611262|NCT02528253|2960027|Superiority||Odds Ratio (OR)|0.93||||0.7366|2-Sided|95.0|0.62|1.41|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611263|NCT02528253|2960028|Superiority||LS Mean Difference|-1.16|Standard Error of the Mean|2.08||0.5764|2-Sided|95.0|-5.25|2.93|||ANCOVA|||Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611264|NCT02528253|2960028|Superiority||LS Mean Difference|-0.53|Standard Error of the Mean|2.17||0.8056|2-Sided|95.0|-4.8|3.73|||ANCOVA|||Change at Week 56: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611265|NCT02528253|2960028|Superiority||LS Mean Difference|-1.42|Standard Error of the Mean|1.59||0.3733|2-Sided|95.0|-4.55|1.71|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611266|NCT02528253|2960028|Superiority||LS Mean Difference|-1.42|Standard Error of the Mean|1.6||0.3749|2-Sided|95.0|-4.57|1.72|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611267|NCT02528253|2960028|Superiority||LS Mean Difference|-2.75|Standard Error of the Mean|1.62||0.0896|2-Sided|95.0|-5.94|0.43|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611268|NCT02528253|2960028|Superiority||LS Mean Difference|-4.18|Standard Error of the Mean|1.73||0.0159|2-Sided|95.0|-7.57|-0.78|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612420|NCT02527161|2960183|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in KOOS Symptoms score from preoperative to 2 years.|
1611269|NCT02528253|2960028|Superiority||LS Mean Difference|-4.18|Standard Error of the Mean|1.73||0.0157|2-Sided|95.0|-7.57|-0.79|||ANCOVA|||Change at Week 16: Percent Activity Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611270|NCT02528253|2960028|Superiority||LS Mean Difference|-3.38|Standard Error of the Mean|2.96||0.255|2-Sided|95.0|-9.22|2.46|||ANCOVA|||Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611271|NCT02528253|2960028|Superiority||LS Mean Difference|-1.93|Standard Error of the Mean|2.97||0.5151|2-Sided|95.0|-7.78|3.92|||ANCOVA|||Change at Week 56: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611272|NCT02528253|2960028|Superiority||LS Mean Difference|-3.66|Standard Error of the Mean|2.34||0.1179|2-Sided|95.0|-8.26|0.93|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611273|NCT02528253|2960028|Superiority||LS Mean Difference|-2.2|Standard Error of the Mean|2.33||0.346|2-Sided|95.0|-6.78|2.38|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611274|NCT02528253|2960028|Superiority||LS Mean Difference|-1.75|Standard Error of the Mean|2.37||0.4613|2-Sided|95.0|-6.41|2.91|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611275|NCT02528253|2960028|Superiority||LS Mean Difference|-5.41|Standard Error of the Mean|2.47||0.0289|2-Sided|95.0|-10.27|-0.56|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611276|NCT02528253|2960028|Superiority||LS Mean Difference|-3.95|Standard Error of the Mean|2.46||0.109|2-Sided|95.0|-8.78|0.88|||ANCOVA|||Change at Week 16: Percent Overall Work Impairment: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611277|NCT02528253|2960028|Superiority||LS Mean Difference|-2.81|Standard Error of the Mean|2.75||0.3078|2-Sided|95.0|-8.24|2.61|||ANCOVA|||Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611278|NCT02528253|2960028|Superiority||LS Mean Difference|-0.87|Standard Error of the Mean|2.75||0.7521|2-Sided|95.0|-6.3|4.56|||ANCOVA|||Change at Week 56: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611279|NCT02528253|2960028|Superiority||LS Mean Difference|-3.11|Standard Error of the Mean|2.27||0.1714|2-Sided|95.0|-7.56|1.35|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611280|NCT02528253|2960028|Superiority||LS Mean Difference|-2.38|Standard Error of the Mean|2.26||0.2935|2-Sided|95.0|-6.82|2.06|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611281|NCT02528253|2960028|Superiority||LS Mean Difference|-1.65|Standard Error of the Mean|2.3||0.4735|2-Sided|95.0|-6.17|2.87|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611282|NCT02528253|2960028|Superiority||LS Mean Difference|-4.76|Standard Error of the Mean|2.4||0.0477|2-Sided|95.0|-9.47|-0.05|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611283|NCT02528253|2960028|Superiority||LS Mean Difference|-4.03|Standard Error of the Mean|2.39||0.0919|2-Sided|95.0|-8.72|0.66|||ANCOVA|||Change at Week 16: Percent Impairment While Working: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611284|NCT02528253|2960028|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|1.53||0.8464|2-Sided|95.0|-3.32|2.72|||ANCOVA|||Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611285|NCT02528253|2960028|Superiority||LS Mean Difference|-0.87|Standard Error of the Mean|1.53||0.5698|2-Sided|95.0|-3.89|2.15|||ANCOVA|||Change at Week 56: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611286|NCT02528253|2960028|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|1.58||0.8902|2-Sided|95.0|-3.32|2.88|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611287|NCT02528253|2960028|Superiority||LS Mean Difference|0.6|Standard Error of the Mean|1.57||0.7007|2-Sided|95.0|-2.48|3.69|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611288|NCT02528253|2960028|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|1.66||0.9629|2-Sided|95.0|-3.33|3.18|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611313|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.68||||0.0114|2-Sided|95.0|1.12|2.51|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611289|NCT02528253|2960028|Superiority||LS Mean Difference|0.74|Standard Error of the Mean|1.64||0.6508|2-Sided|95.0|-2.49|3.98|||ANCOVA|||Change at Week 16: Percent Work Time Missed: ANCOVA model included treatment as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611290|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.01||||0.9626|2-Sided|95.0|0.73|1.39|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611291|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.32||||0.0846|2-Sided|95.0|0.96|1.81|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611292|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.09||||0.6022|2-Sided|95.0|0.79|1.5|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611293|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.25||||0.1708|2-Sided|95.0|0.91|1.72|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611294|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.11||||0.5223|2-Sided|95.0|0.8|1.53|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611295|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.47||||0.0178|2-Sided|95.0|1.07|2.01|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611296|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.12||||0.4763|2-Sided|95.0|0.81|1.56|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611297|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.42||||0.0304|2-Sided|95.0|1.03|1.96|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611298|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.21||||0.2478|2-Sided|95.0|0.88|1.65|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611299|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.39||||0.04|2-Sided|95.0|1.02|1.91|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611300|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.51||||0.0093|2-Sided|95.0|1.11|2.07|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611301|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.45||||0.0207|2-Sided|95.0|1.06|2.0|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611302|NCT02528253|2960032|Superiority||Odds Ratio (OR)|0.96||||0.79|2-Sided|95.0|0.69|1.33|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611303|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.45||||0.0347|2-Sided|95.0|1.03|2.04|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611304|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.39||||0.063|2-Sided|95.0|0.98|1.97|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611305|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.38||||0.0586|2-Sided|95.0|0.99|1.94|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611306|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.2||||0.3084|2-Sided|95.0|0.85|1.7|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611307|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.27||||0.1992|2-Sided|95.0|0.88|1.84|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611308|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.76||||0.004|2-Sided|95.0|1.2|2.59|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611309|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.53||||0.0363|2-Sided|95.0|1.03|2.27|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611310|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.59||||0.0109|2-Sided|95.0|1.11|2.28|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611311|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.7||||0.0041|2-Sided|95.0|1.18|2.44|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611312|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.06||||0.7857|2-Sided|95.0|0.71|1.56|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611314|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.79||||0.0048|2-Sided|95.0|1.2|2.69|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611315|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.58||||0.0308|2-Sided|95.0|1.04|2.38|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611316|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.25||||0.3194|2-Sided|95.0|0.81|1.94|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611317|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.02||||0.9263|2-Sided|95.0|0.65|1.61|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611318|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.61||||0.0445|2-Sided|95.0|1.01|2.56|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611319|NCT02528253|2960032|Superiority||Odds Ratio (OR)|1.28||||0.326|2-Sided|95.0|0.78|2.08|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of low back pain, baseline average LBPI, and treatment.|
1611320|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.18||||0.2163|2-Sided|95.0|0.91|1.54|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611321|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.14||||0.3336|2-Sided|95.0|0.87|1.49|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611322|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.09||||0.5239|2-Sided|95.0|0.84|1.42|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611323|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.2||||0.1749|2-Sided|95.0|0.92|1.57|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611324|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.16||||0.2727|2-Sided|95.0|0.89|1.51|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611325|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.28||||0.0626|2-Sided|95.0|0.99|1.67|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611326|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.28||||0.0633|2-Sided|95.0|0.99|1.66|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611327|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.27||||0.0749|2-Sided|95.0|0.98|1.65|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611328|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.22||||0.1278|2-Sided|95.0|0.94|1.59|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611329|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.35||||0.0251|2-Sided|95.0|1.04|1.75|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611330|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.06||||0.6629|2-Sided|95.0|0.81|1.38|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611331|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.56||||0.0021|2-Sided|95.0|1.18|2.08|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611332|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.41||||0.0179|2-Sided|95.0|1.06|1.88|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611333|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.56||||0.0033|2-Sided|95.0|1.16|2.1|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611334|NCT02528253|2960033|Superiority||Odds Ratio (OR)|2.21|||<|0.0001|2-Sided|95.0|1.62|3.03|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611335|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.8|||<|0.0003|2-Sided|95.0|1.31|2.47|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611561|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.53||||0.0223|2-Sided|95.0|1.06|2.2|||Regression, Logistic|||Week 48, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611336|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.44|||<|0.029|2-Sided|95.0|1.04|1.99|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611337|NCT02528253|2960033|Superiority||Odds Ratio (OR)|2.37|||<|0.0001|2-Sided|95.0|1.69|3.32|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611338|NCT02528253|2960033|Superiority||Odds Ratio (OR)|2.03|||<|0.0001|2-Sided|95.0|1.44|2.86|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611339|NCT02528253|2960033|Superiority||Odds Ratio (OR)|1.62|||<|0.03|2-Sided|95.0|1.05|2.51|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611340|NCT02528253|2960033|Superiority||Odds Ratio (OR)|2.68|||<|0.0001|2-Sided|95.0|1.73|4.16|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611341|NCT02528253|2960033|Superiority||Odds Ratio (OR)|2.14|||<|0.001|2-Sided|95.0|1.36|3.36|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included treatment as fixed effect and baseline average LBPI, baseline PGA, and baseline RMDQ as covariates.|
1611342|NCT02528253|2960035|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.22||0.2664|2-Sided|95.0|-0.67|0.19|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611343|NCT02528253|2960035|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.22||0.5586|2-Sided|95.0|-0.56|0.3|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611344|NCT02528253|2960035|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.22||0.4571|2-Sided|95.0|-0.58|0.26|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611345|NCT02528253|2960035|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.22||0.4932|2-Sided|95.0|-0.57|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611346|NCT02528253|2960035|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.21||0.2822|2-Sided|95.0|-0.65|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611347|NCT02528253|2960035|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.22||0.3326|2-Sided|95.0|-0.63|0.21|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611348|NCT02528253|2960035|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.22||0.2994|2-Sided|95.0|-0.65|0.2|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611349|NCT02528253|2960035|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.21||0.3527|2-Sided|95.0|-0.62|0.22|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611350|NCT02528253|2960035|Superiority||LS Mean Difference|-0.36|Standard Error of the Mean|0.2||0.0781|2-Sided|95.0|-0.76|0.04|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611351|NCT02528253|2960035|Superiority||LS Mean Difference|-0.25|Standard Error of the Mean|0.2||0.2157|2-Sided|95.0|-0.65|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611352|NCT02528253|2960035|Superiority||LS Mean Difference|-0.46|Standard Error of the Mean|0.18||0.0133|2-Sided|95.0|-0.82|-0.09|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1612359|NCT02528188|2960144|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.08||0.102|2-Sided|95.0|-0.3|0.03|||ANCOVA|||Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.|
1611353|NCT02528253|2960035|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.18||0.1351|2-Sided|95.0|-0.64|0.09|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611354|NCT02528253|2960035|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.18||0.2028|2-Sided|95.0|-0.59|0.13|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611355|NCT02528253|2960035|Superiority||LS Mean Difference|-0.69|Standard Error of the Mean|0.2||0.0006|2-Sided|95.0|-1.08|-0.29|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611356|NCT02528253|2960035|Superiority||LS Mean Difference|-0.51|Standard Error of the Mean|0.2||0.0115|2-Sided|95.0|-0.9|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611357|NCT02528253|2960035|Superiority||LS Mean Difference|-0.46|Standard Error of the Mean|0.17||0.0064|2-Sided|95.0|-0.78|-0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611358|NCT02528253|2960035|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.17||0.2408|2-Sided|95.0|-0.53|0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611359|NCT02528253|2960035|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.17||0.2768|2-Sided|95.0|-0.51|0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611360|NCT02528253|2960035|Superiority||LS Mean Difference|-0.64|Standard Error of the Mean|0.18||0.0005|2-Sided|95.0|-1.0|-0.28|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611361|NCT02528253|2960035|Superiority||LS Mean Difference|-0.38|Standard Error of the Mean|0.18||0.0387|2-Sided|95.0|-0.74|-0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611362|NCT02528253|2960035|Superiority||LS Mean Difference|-0.67|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-0.99|-0.35|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611363|NCT02528253|2960035|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.16|<|0.0696|2-Sided|95.0|-0.62|0.02|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611364|NCT02528253|2960035|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.17|<|0.1799|2-Sided|95.0|-0.55|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611365|NCT02528253|2960035|Superiority||LS Mean Difference|-0.89|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.25|-0.54|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611366|NCT02528253|2960035|Superiority||LS Mean Difference|-0.52|Standard Error of the Mean|0.18|<|0.0041|2-Sided|95.0|-0.87|-0.17|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611367|NCT02528253|2960035|Superiority||LS Mean Difference|-0.48|Standard Error of the Mean|0.15|<|0.0015|2-Sided|95.0|-0.77|-0.18|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611368|NCT02528253|2960035|Superiority||LS Mean Difference|-0.33|Standard Error of the Mean|0.15|<|0.029|2-Sided|95.0|-0.63|-0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611369|NCT02528253|2960035|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.15|<|0.1291|2-Sided|95.0|-0.53|0.07|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611370|NCT02528253|2960035|Superiority||LS Mean Difference|-0.71|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.03|-0.38|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611371|NCT02528253|2960035|Superiority||LS Mean Difference|-0.56|Standard Error of the Mean|0.16|<|0.0007|2-Sided|95.0|-0.88|-0.24|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with normal work, and baseline average LBPI as covariates, and study site as a random effect.|
1611372|NCT02528253|2960037|Superiority||LS Mean Difference|-0.36|Standard Error of the Mean|0.21||0.0893|2-Sided|95.0|-0.79|0.06|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611373|NCT02528253|2960037|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.22||0.368|2-Sided|95.0|-0.62|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611374|NCT02528253|2960037|Superiority||LS Mean Difference|-0.39|Standard Error of the Mean|0.22||0.0806|2-Sided|95.0|-0.82|0.05|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611375|NCT02528253|2960037|Superiority||LS Mean Difference|-0.27|Standard Error of the Mean|0.23||0.2293|2-Sided|95.0|-0.71|0.17|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611376|NCT02528253|2960037|Superiority||LS Mean Difference|-0.4|Standard Error of the Mean|0.22||0.0737|2-Sided|95.0|-0.83|0.04|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611377|NCT02528253|2960037|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.22||0.3041|2-Sided|95.0|-0.65|0.2|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611378|NCT02528253|2960037|Superiority||LS Mean Difference|-0.4|Standard Error of the Mean|0.21||0.0599|2-Sided|95.0|-0.82|0.02|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611379|NCT02528253|2960037|Superiority||LS Mean Difference|-0.35|Standard Error of the Mean|0.21||0.1049|2-Sided|95.0|-0.77|0.07|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611380|NCT02528253|2960037|Superiority||LS Mean Difference|-0.5|Standard Error of the Mean|0.21||0.0169|2-Sided|95.0|-0.91|-0.09|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611381|NCT02528253|2960037|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.21||0.1539|2-Sided|95.0|-0.72|0.11|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611382|NCT02528253|2960037|Superiority||LS Mean Difference|-0.43|Standard Error of the Mean|0.19||0.025|2-Sided|95.0|-0.81|-0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611383|NCT02528253|2960037|Superiority||LS Mean Difference|-0.38|Standard Error of the Mean|0.19||0.0468|2-Sided|95.0|-0.75|-0.01|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611384|NCT02528253|2960037|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.2||0.6624|2-Sided|95.0|-0.47|0.3|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611385|NCT02528253|2960037|Superiority||LS Mean Difference|-0.52|Standard Error of the Mean|0.21||0.0136|2-Sided|95.0|-0.93|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611386|NCT02528253|2960037|Superiority||LS Mean Difference|-0.46|Standard Error of the Mean|0.21||0.0236|2-Sided|95.0|-0.87|-0.06|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611387|NCT02528253|2960037|Superiority||LS Mean Difference|-0.44|Standard Error of the Mean|0.18||0.0129|2-Sided|95.0|-0.78|-0.09|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611388|NCT02528253|2960037|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.18||0.1652|2-Sided|95.0|-0.59|0.1|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611389|NCT02528253|2960037|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.18||0.1155|2-Sided|95.0|-0.63|0.07|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611390|NCT02528253|2960037|Superiority||LS Mean Difference|-0.72|Standard Error of the Mean|0.19||0.0002|2-Sided|95.0|-1.09|-0.34|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611391|NCT02528253|2960037|Superiority||LS Mean Difference|-0.52|Standard Error of the Mean|0.19||0.0063|2-Sided|95.0|-0.9|-0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611392|NCT02528253|2960037|Superiority||LS Mean Difference|-0.64|Standard Error of the Mean|0.17||0.0002|2-Sided|95.0|-0.98|-0.31|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611393|NCT02528253|2960037|Superiority||LS Mean Difference|-0.45|Standard Error of the Mean|0.17||0.0084|2-Sided|95.0|-0.78|-0.11|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611394|NCT02528253|2960037|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.17||0.2056|2-Sided|95.0|-0.55|0.12|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611395|NCT02528253|2960037|Superiority||LS Mean Difference|-0.86|Standard Error of the Mean|0.19|<|0.0001|2-Sided|95.0|-1.22|-0.49|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611396|NCT02528253|2960037|Superiority||LS Mean Difference|-0.66|Standard Error of the Mean|0.18|<|0.0003|2-Sided|95.0|-1.02|-0.3|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611397|NCT02528253|2960037|Superiority||LS Mean Difference|-0.35|Standard Error of the Mean|0.16|<|0.0289|2-Sided|95.0|-0.66|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611398|NCT02528253|2960037|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.16|<|0.0686|2-Sided|95.0|-0.6|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611399|NCT02528253|2960037|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.16|<|0.1712|2-Sided|95.0|-0.53|0.09|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611400|NCT02528253|2960037|Superiority||LS Mean Difference|-0.57|Standard Error of the Mean|0.18|<|0.0013|2-Sided|95.0|-0.91|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611401|NCT02528253|2960037|Superiority||LS Mean Difference|-0.51|Standard Error of the Mean|0.18|<|0.0037|2-Sided|95.0|-0.85|-0.17|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with sleep, and baseline average LBPI as covariates, and study site as a random effect.|
1611402|NCT02528253|2960039|Superiority||LS Mean Difference|-0.38|Standard Error of the Mean|0.21||0.0641|2-Sided|95.0|-0.79|0.02|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611403|NCT02528253|2960039|Superiority||LS Mean Difference|-0.17|Standard Error of the Mean|0.21||0.4036|2-Sided|95.0|-0.58|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611404|NCT02528253|2960039|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.2||0.1375|2-Sided|95.0|-0.7|0.1|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611405|NCT02528253|2960039|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.2||0.311|2-Sided|95.0|-0.59|0.19|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611406|NCT02528253|2960039|Superiority||LS Mean Difference|-0.36|Standard Error of the Mean|0.2||0.0745|2-Sided|95.0|-0.76|0.04|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611407|NCT02528253|2960039|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.21||0.2847|2-Sided|95.0|-0.63|0.18|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611408|NCT02528253|2960039|Superiority||LS Mean Difference|-0.35|Standard Error of the Mean|0.2||0.0795|2-Sided|95.0|-0.75|0.04|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611409|NCT02528253|2960039|Superiority||LS Mean Difference|-0.27|Standard Error of the Mean|0.2||0.1838|2-Sided|95.0|-0.66|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611410|NCT02528253|2960039|Superiority||LS Mean Difference|-0.42|Standard Error of the Mean|0.2||0.0331|2-Sided|95.0|-0.81|-0.03|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611411|NCT02528253|2960039|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.2||0.2243|2-Sided|95.0|-0.63|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611412|NCT02528253|2960039|Superiority||LS Mean Difference|-0.46|Standard Error of the Mean|0.18||0.0086|2-Sided|95.0|-0.81|-0.12|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611413|NCT02528253|2960039|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.18||0.2271|2-Sided|95.0|-0.56|0.13|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611414|NCT02528253|2960039|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.18||0.4535|2-Sided|95.0|-0.48|0.21|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611415|NCT02528253|2960039|Superiority||LS Mean Difference|-0.59|Standard Error of the Mean|0.19||0.0021|2-Sided|95.0|-0.97|-0.22|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611562|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.49||||0.0065|2-Sided|95.0|1.12|1.99|||Regression, Logistic|||Week 48, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611416|NCT02528253|2960039|Superiority||LS Mean Difference|-0.35|Standard Error of the Mean|0.19||0.0737|2-Sided|95.0|-0.72|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611417|NCT02528253|2960039|Superiority||LS Mean Difference|-0.43|Standard Error of the Mean|0.16||0.0078|2-Sided|95.0|-0.74|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611418|NCT02528253|2960039|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.16||0.0659|2-Sided|95.0|-0.62|0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611419|NCT02528253|2960039|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.16||0.4173|2-Sided|95.0|-0.45|0.19|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611420|NCT02528253|2960039|Superiority||LS Mean Difference|-0.56|Standard Error of the Mean|0.18||0.0015|2-Sided|95.0|-0.91|-0.21|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611421|NCT02528253|2960039|Superiority||LS Mean Difference|-0.43|Standard Error of the Mean|0.18||0.0158|2-Sided|95.0|-0.78|-0.08|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611422|NCT02528253|2960039|Superiority||LS Mean Difference|-0.52|Standard Error of the Mean|0.16||0.0013|2-Sided|95.0|-0.84|-0.2|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611423|NCT02528253|2960039|Superiority||LS Mean Difference|-0.35|Standard Error of the Mean|0.16||0.0305|2-Sided|95.0|-0.66|-0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611424|NCT02528253|2960039|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.16||0.1873|2-Sided|95.0|-0.53|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611425|NCT02528253|2960039|Superiority||LS Mean Difference|-0.74|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.08|-0.39|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611426|NCT02528253|2960039|Superiority||LS Mean Difference|-0.56|Standard Error of the Mean|0.17|<|0.0013|2-Sided|95.0|-0.91|-0.22|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611427|NCT02528253|2960039|Superiority||LS Mean Difference|-0.34|Standard Error of the Mean|0.15|<|0.0208|2-Sided|95.0|-0.63|-0.05|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611428|NCT02528253|2960039|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.15|<|0.2197|2-Sided|95.0|-0.47|0.11|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611429|NCT02528253|2960039|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.15|<|0.0756|2-Sided|95.0|-0.56|0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611430|NCT02528253|2960039|Superiority||LS Mean Difference|-0.61|Standard Error of the Mean|0.16|<|0.0002|2-Sided|95.0|-0.93|-0.29|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611563|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.42||||0.0179|2-Sided|95.0|1.06|1.9|||Regression, Logistic|||Week 48, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1614558|NCT02485561|2963721|Superiority||F-value|1.68||||0.19|2-Sided||||||ANOVA||||
1611431|NCT02528253|2960039|Superiority||LS Mean Difference|-0.45|Standard Error of the Mean|0.16|<|0.0059|2-Sided|95.0|-0.76|-0.13|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with walking ability, and baseline average LBPI as covariates, and study site as a random effect.|
1611432|NCT02528253|2960041|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.22||0.5146|2-Sided|95.0|-0.56|0.28|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611433|NCT02528253|2960041|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.21||0.8373|2-Sided|95.0|-0.47|0.38|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611434|NCT02528253|2960041|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.21||0.5065|2-Sided|95.0|-0.56|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611435|NCT02528253|2960041|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.22||0.5157|2-Sided|95.0|-0.56|0.28|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611436|NCT02528253|2960041|Superiority||LS Mean Difference|-0.19|Standard Error of the Mean|0.21||0.3752|2-Sided|95.0|-0.6|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611437|NCT02528253|2960041|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.22||0.5195|2-Sided|95.0|-0.57|0.29|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611438|NCT02528253|2960041|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.21||0.2584|2-Sided|95.0|-0.65|0.17|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611439|NCT02528253|2960041|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.21||0.2986|2-Sided|95.0|-0.63|0.19|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611440|NCT02528253|2960041|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.2||0.1922|2-Sided|95.0|-0.66|0.13|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611441|NCT02528253|2960041|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.2||0.3732|2-Sided|95.0|-0.57|0.21|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611442|NCT02528253|2960041|Superiority||LS Mean Difference|-0.45|Standard Error of the Mean|0.18||0.0117|2-Sided|95.0|-0.81|-0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611443|NCT02528253|2960041|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.18||0.0956|2-Sided|95.0|-0.66|0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611444|NCT02528253|2960041|Superiority||LS Mean Difference|-0.19|Standard Error of the Mean|0.18||0.2966|2-Sided|95.0|-0.54|0.17|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611445|NCT02528253|2960041|Superiority||LS Mean Difference|-0.64|Standard Error of the Mean|0.2||0.0012|2-Sided|95.0|-1.03|-0.25|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611564|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.23||||0.1222|2-Sided|95.0|0.95|1.6|||Regression, Logistic|||Week 48, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611446|NCT02528253|2960041|Superiority||LS Mean Difference|-0.49|Standard Error of the Mean|0.2||0.0118|2-Sided|95.0|-0.88|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611447|NCT02528253|2960041|Superiority||LS Mean Difference|-0.32|Standard Error of the Mean|0.17||0.0505|2-Sided|95.0|-0.65|0.0|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611448|NCT02528253|2960041|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.17||0.3763|2-Sided|95.0|-0.47|0.18|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611449|NCT02528253|2960041|Superiority||LS Mean Difference|-0.17|Standard Error of the Mean|0.16||0.316|2-Sided|95.0|-0.49|0.16|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611450|NCT02528253|2960041|Superiority||LS Mean Difference|-0.49|Standard Error of the Mean|0.18||0.0074|2-Sided|95.0|-0.85|-0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611451|NCT02528253|2960041|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|0.18||0.0841|2-Sided|95.0|-0.66|0.04|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611452|NCT02528253|2960041|Superiority||LS Mean Difference|-0.56|Standard Error of the Mean|0.16||0.0005|2-Sided|95.0|-0.88|-0.25|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611453|NCT02528253|2960041|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|0.16||0.0573|2-Sided|95.0|-0.63|0.01|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611454|NCT02528253|2960041|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.16||0.1859|2-Sided|95.0|-0.54|0.1|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611455|NCT02528253|2960041|Superiority||LS Mean Difference|-0.78|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.13|-0.44|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611456|NCT02528253|2960041|Superiority||LS Mean Difference|-0.53|Standard Error of the Mean|0.18|<|0.0027|2-Sided|95.0|-0.87|-0.18|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611457|NCT02528253|2960041|Superiority||LS Mean Difference|-0.38|Standard Error of the Mean|0.14|<|0.0085|2-Sided|95.0|-0.66|-0.1|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611458|NCT02528253|2960041|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|0.14|<|0.0271|2-Sided|95.0|-0.59|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611459|NCT02528253|2960041|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.14|<|0.6194|2-Sided|95.0|-0.35|0.21|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611460|NCT02528253|2960041|Superiority||LS Mean Difference|-0.45|Standard Error of the Mean|0.16|<|0.0044|2-Sided|95.0|-0.76|-0.14|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611565|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.23||||0.1202|2-Sided|95.0|0.95|1.6|||Regression, Logistic|||Week 48, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1614559|NCT02485561|2963722|Superiority||F-value|2.0||||0.14|2-Sided||||||ANOVA||||
1611461|NCT02528253|2960041|Superiority||LS Mean Difference|-0.39|Standard Error of the Mean|0.16|<|0.0137|2-Sided|95.0|-0.69|-0.08|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference with general activity, and baseline average LBPI as covariates, and study site as a random effect.|
1611462|NCT02528253|2960043|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.2||0.2562|2-Sided|95.0|-0.62|0.16|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611463|NCT02528253|2960043|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.2||0.5818|2-Sided|95.0|-0.5|0.28|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611464|NCT02528253|2960043|Superiority||LS Mean Difference|-0.19|Standard Error of the Mean|0.2||0.3391|2-Sided|95.0|-0.58|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611465|NCT02528253|2960043|Superiority||LS Mean Difference|-0.19|Standard Error of the Mean|0.2||0.3408|2-Sided|95.0|-0.58|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611466|NCT02528253|2960043|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.2||0.2253|2-Sided|95.0|-0.62|0.15|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611467|NCT02528253|2960043|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.2||0.3164|2-Sided|95.0|-0.59|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611468|NCT02528253|2960043|Superiority||LS Mean Difference|-0.27|Standard Error of the Mean|0.2||0.1751|2-Sided|95.0|-0.66|0.12|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611469|NCT02528253|2960043|Superiority||LS Mean Difference|-0.27|Standard Error of the Mean|0.2||0.1673|2-Sided|95.0|-0.65|0.11|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611470|NCT02528253|2960043|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|0.19||0.1088|2-Sided|95.0|-0.69|0.07|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611471|NCT02528253|2960043|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.19||0.2396|2-Sided|95.0|-0.61|0.15|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611472|NCT02528253|2960043|Superiority||LS Mean Difference|-0.43|Standard Error of the Mean|0.17||0.0107|2-Sided|95.0|-0.76|-0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611473|NCT02528253|2960043|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.17||0.1209|2-Sided|95.0|-0.59|0.07|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611474|NCT02528253|2960043|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.17||0.3906|2-Sided|95.0|-0.48|0.19|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611475|NCT02528253|2960043|Superiority||LS Mean Difference|-0.58|Standard Error of the Mean|0.18||0.0019|2-Sided|95.0|-0.94|-0.21|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611476|NCT02528253|2960043|Superiority||LS Mean Difference|-0.41|Standard Error of the Mean|0.18||0.027|2-Sided|95.0|-0.77|-0.05|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1614560|NCT02485561|2963722|Superiority||F-value|16.31|||<|0.001|2-Sided||||||ANOVA||||
1611477|NCT02528253|2960043|Superiority||LS Mean Difference|-0.39|Standard Error of the Mean|0.15||0.0121|2-Sided|95.0|-0.69|-0.08|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611478|NCT02528253|2960043|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.15||0.0961|2-Sided|95.0|-0.56|0.05|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611479|NCT02528253|2960043|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.15||0.2264|2-Sided|95.0|-0.48|0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611480|NCT02528253|2960043|Superiority||LS Mean Difference|-0.57|Standard Error of the Mean|0.17||0.0007|2-Sided|95.0|-0.9|-0.24|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611481|NCT02528253|2960043|Superiority||LS Mean Difference|-0.44|Standard Error of the Mean|0.17||0.0091|2-Sided|95.0|-0.77|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611482|NCT02528253|2960043|Superiority||LS Mean Difference|-0.55|Standard Error of the Mean|0.15||0.0003|2-Sided|95.0|-0.85|-0.25|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611483|NCT02528253|2960043|Superiority||LS Mean Difference|-0.37|Standard Error of the Mean|0.15||0.016|2-Sided|95.0|-0.66|-0.07|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611484|NCT02528253|2960043|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.15||0.1198|2-Sided|95.0|-0.53|0.06|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611485|NCT02528253|2960043|Superiority||LS Mean Difference|-0.78|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.1|-0.46|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611486|NCT02528253|2960043|Superiority||LS Mean Difference|-0.6|Standard Error of the Mean|0.16|<|0.0002|2-Sided|95.0|-0.92|-0.28|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611487|NCT02528253|2960043|Superiority||LS Mean Difference|-0.41|Standard Error of the Mean|0.14|<|0.0029|2-Sided|95.0|-0.67|-0.14|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611488|NCT02528253|2960043|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|0.14|<|0.0209|2-Sided|95.0|-0.58|-0.05|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611489|NCT02528253|2960043|Superiority||LS Mean Difference|-0.17|Standard Error of the Mean|0.14|<|0.2272|2-Sided|95.0|-0.43|-0.1|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611490|NCT02528253|2960043|Superiority||LS Mean Difference|-0.57|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-0.87|-0.28|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611491|NCT02528253|2960043|Superiority||LS Mean Difference|-0.48|Standard Error of the Mean|0.15|<|0.0013|2-Sided|95.0|-0.77|-0.19|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf pain interference index, and baseline average LBPI as covariates, and study site as a random effect.|
1611492|NCT02528253|2960045|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.2||0.2663|2-Sided|95.0|-0.6|0.17|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1612421|NCT02527161|2960183|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in KOOS Pain score from preoperative to 2 years.|
1611493|NCT02528253|2960045|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|0.2||0.8752|2-Sided|95.0|-0.42|0.36|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611494|NCT02528253|2960045|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.2||0.4346|2-Sided|95.0|-0.54|0.23|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611495|NCT02528253|2960045|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.2||0.5861|2-Sided|95.0|-0.5|0.29|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611496|NCT02528253|2960045|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.2||0.2754|2-Sided|95.0|-0.6|0.17|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611497|NCT02528253|2960045|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.2||0.4823|2-Sided|95.0|-0.53|0.25|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611498|NCT02528253|2960045|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.19||0.1997|2-Sided|95.0|-0.62|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611499|NCT02528253|2960045|Superiority||LS Mean Difference|-0.19|Standard Error of the Mean|0.19||0.3249|2-Sided|95.0|-0.56|0.18|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611500|NCT02528253|2960045|Superiority||LS Mean Difference|-0.27|Standard Error of the Mean|0.19||0.1482|2-Sided|95.0|-0.64|0.1|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611501|NCT02528253|2960045|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.19||0.4776|2-Sided|95.0|-0.5|0.23|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611502|NCT02528253|2960045|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.16||0.0724|2-Sided|95.0|-0.6|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611503|NCT02528253|2960045|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.16||0.2231|2-Sided|95.0|-0.51|0.12|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611504|NCT02528253|2960045|Superiority||LS Mean Difference|-0.17|Standard Error of the Mean|0.16||0.2923|2-Sided|95.0|-0.49|0.15|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611505|NCT02528253|2960045|Superiority||LS Mean Difference|-0.46|Standard Error of the Mean|0.18||0.0092|2-Sided|95.0|-0.8|-0.11|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611506|NCT02528253|2960045|Superiority||LS Mean Difference|-0.37|Standard Error of the Mean|0.18||0.0365|2-Sided|95.0|-0.71|-0.02|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611507|NCT02528253|2960045|Superiority||LS Mean Difference|-0.4|Standard Error of the Mean|0.14||0.0058|2-Sided|95.0|-0.68|-0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611508|NCT02528253|2960045|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.15||0.2786|2-Sided|95.0|-0.44|0.13|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1612422|NCT02527161|2960184|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in KOOS QOL score from preoperative to 12 months.|
1611509|NCT02528253|2960045|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|0.15||0.0361|2-Sided|95.0|-0.59|-0.02|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611510|NCT02528253|2960045|Superiority||LS Mean Difference|-0.7|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.01|-0.39|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611511|NCT02528253|2960045|Superiority||LS Mean Difference|-0.46|Standard Error of the Mean|0.16|<|0.0034|2-Sided|95.0|-0.77|-0.15|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611512|NCT02528253|2960045|Superiority||LS Mean Difference|-0.46|Standard Error of the Mean|0.14|<|0.0008|2-Sided|95.0|-0.73|-0.19|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611513|NCT02528253|2960045|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.14|<|0.0336|2-Sided|95.0|-0.55|-0.02|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611514|NCT02528253|2960045|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.14|<|0.079|2-Sided|95.0|-0.5|0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611515|NCT02528253|2960045|Superiority||LS Mean Difference|-0.7|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-0.99|-0.41|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611516|NCT02528253|2960045|Superiority||LS Mean Difference|-0.53|Standard Error of the Mean|0.15|<|0.0003|2-Sided|95.0|-0.81|-0.24|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611517|NCT02528253|2960045|Superiority||LS Mean Difference|-0.27|Standard Error of the Mean|0.12|<|0.0212|2-Sided|95.0|-0.49|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611518|NCT02528253|2960045|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.12|<|0.0845|2-Sided|95.0|-0.42|0.03|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611519|NCT02528253|2960045|Superiority||LS Mean Difference|-0.27|Standard Error of the Mean|0.12|<|0.0193|2-Sided|95.0|-0.5|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611520|NCT02528253|2960045|Superiority||LS Mean Difference|-0.54|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-0.79|-0.29|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611521|NCT02528253|2960045|Superiority||LS Mean Difference|-0.47|Standard Error of the Mean|0.13|<|0.0002|2-Sided|95.0|-0.72|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf average pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611522|NCT02528253|2960047|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.22||0.1876|2-Sided|95.0|-0.71|0.14|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611523|NCT02528253|2960047|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.22||0.3438|2-Sided|95.0|-0.65|0.23|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611524|NCT02528253|2960047|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.21||0.1778|2-Sided|95.0|-0.71|0.13|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611566|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.2||||0.1534|2-Sided|95.0|0.93|1.55|||Regression, Logistic|||Week 48, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611525|NCT02528253|2960047|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.22||0.2997|2-Sided|95.0|-0.65|0.2|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611526|NCT02528253|2960047|Superiority||LS Mean Difference|-0.27|Standard Error of the Mean|0.21||0.2|2-Sided|95.0|-0.68|0.14|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611527|NCT02528253|2960047|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.21||0.384|2-Sided|95.0|-0.6|0.23|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611528|NCT02528253|2960047|Superiority||LS Mean Difference|-0.32|Standard Error of the Mean|0.21||0.1199|2-Sided|95.0|-0.73|0.08|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611529|NCT02528253|2960047|Superiority||LS Mean Difference|-0.25|Standard Error of the Mean|0.21||0.2339|2-Sided|95.0|-0.66|0.16|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611530|NCT02528253|2960047|Superiority||LS Mean Difference|-0.35|Standard Error of the Mean|0.2||0.0799|2-Sided|95.0|-0.74|0.04|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611531|NCT02528253|2960047|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.21||0.4603|2-Sided|95.0|-0.56|0.25|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611532|NCT02528253|2960047|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|0.17||0.0734|2-Sided|95.0|-0.64|0.03|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611533|NCT02528253|2960047|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.17||0.1083|2-Sided|95.0|-0.62|0.06|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611534|NCT02528253|2960047|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.17||0.1707|2-Sided|95.0|-0.58|0.1|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611535|NCT02528253|2960047|Superiority||LS Mean Difference|-0.54|Standard Error of the Mean|0.19||0.0038|2-Sided|95.0|-0.91|-0.18|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611536|NCT02528253|2960047|Superiority||LS Mean Difference|-0.52|Standard Error of the Mean|0.19||0.0058|2-Sided|95.0|-0.88|-0.15|||ANCOVA|||Change at Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611537|NCT02528253|2960047|Superiority||LS Mean Difference|-0.49|Standard Error of the Mean|0.15||0.0016|2-Sided|95.0|-0.79|-0.18|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611538|NCT02528253|2960047|Superiority||LS Mean Difference|-0.19|Standard Error of the Mean|0.15||0.215|2-Sided|95.0|-0.5|0.11|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611539|NCT02528253|2960047|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.16||0.0977|2-Sided|95.0|-0.57|0.05|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611540|NCT02528253|2960047|Superiority||LS Mean Difference|-0.75|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.08|-0.41|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611567|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.09||||0.4925|2-Sided|95.0|0.85|1.41|||Regression, Logistic|||Week 48, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611541|NCT02528253|2960047|Superiority||LS Mean Difference|-0.45|Standard Error of the Mean|0.17|<|0.0079|2-Sided|95.0|-0.78|-0.12|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611542|NCT02528253|2960047|Superiority||LS Mean Difference|-0.52|Standard Error of the Mean|0.15|<|0.0004|2-Sided|95.0|-0.8|-0.23|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611543|NCT02528253|2960047|Superiority||LS Mean Difference|-0.32|Standard Error of the Mean|0.14|<|0.0258|2-Sided|95.0|-0.6|-0.04|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611544|NCT02528253|2960047|Superiority||LS Mean Difference|-0.25|Standard Error of the Mean|0.15|<|0.0844|2-Sided|95.0|-0.54|0.03|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611545|NCT02528253|2960047|Superiority||LS Mean Difference|-0.77|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.08|-0.46|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611546|NCT02528253|2960047|Superiority||LS Mean Difference|-0.57|Standard Error of the Mean|0.16|<|0.0003|2-Sided|95.0|-0.88|-0.27|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611547|NCT02528253|2960047|Superiority||LS Mean Difference|-0.36|Standard Error of the Mean|0.12|<|0.0032|2-Sided|95.0|-0.6|-0.12|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611548|NCT02528253|2960047|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.12|<|0.0356|2-Sided|95.0|-0.5|-0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611549|NCT02528253|2960047|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.12|<|0.0615|2-Sided|95.0|-0.47|0.01|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611550|NCT02528253|2960047|Superiority||LS Mean Difference|-0.59|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-0.85|-0.33|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611551|NCT02528253|2960047|Superiority||LS Mean Difference|-0.49|Standard Error of the Mean|0.13|<|0.0003|2-Sided|95.0|-0.75|-0.22|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline BPI-sf worst pain, and baseline average LBPI as covariates, and study site as a random effect.|
1611552|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.74||||0.0021|2-Sided|95.0|1.22|2.47|||Regression, Logistic|||Week 56, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611553|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.64||||0.0063|2-Sided|95.0|1.15|2.34|||Regression, Logistic|||Week 56, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611554|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.39||||0.024|2-Sided|95.0|1.04|1.86|||Regression, Logistic|||Week 56, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611555|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.36||||0.0389|2-Sided|95.0|1.02|1.81|||Regression, Logistic|||Week 56, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611556|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.34||||0.0285|2-Sided|95.0|1.03|1.74|||Regression, Logistic|||Week 56, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611557|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.21||||0.1631|2-Sided|95.0|0.93|1.57|||Regression, Logistic|||Week 56, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611558|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.23||||0.1093|2-Sided|95.0|0.95|1.59|||Regression, Logistic|||Week 56, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611559|NCT02528253|2960049|Superiority||Odds Ratio (OR)|0.99||||0.9385|2-Sided|95.0|0.77|1.28|||Regression, Logistic|||Week 56, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611560|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.68||||0.0045|2-Sided|95.0|1.17|2.4|||Regression, Logistic|||Week 48, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611568|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.62||||0.0085|2-Sided|95.0|1.13|2.32|||Regression, Logistic|||Week 40, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611569|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.64||||0.007|2-Sided|95.0|1.14|2.35|||Regression, Logistic|||Week 40, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611570|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.38||||0.0257|2-Sided|95.0|1.04|1.84|||Regression, Logistic|||Week 40, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611571|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.42||||0.0164|2-Sided|95.0|1.07|1.88|||Regression, Logistic|||Week 40, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611572|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.32||||0.035|2-Sided|95.0|1.02|1.71|||Regression, Logistic|||Week 40, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611573|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.19||||0.1823|2-Sided|95.0|0.92|1.55|||Regression, Logistic|||Week 40, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611574|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.32||||0.0326|2-Sided|95.0|1.02|1.7|||Regression, Logistic|||Week 40, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611575|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.15||||0.2777|2-Sided|95.0|0.89|1.48|||Regression, Logistic|||Week 40, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611576|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.68||||0.0043|2-Sided|95.0|1.18|2.4|||Regression, Logistic|||Week 32, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611577|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.67||||0.005|2-Sided|95.0|1.17|2.38|||Regression, Logistic|||Week 32, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611578|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.63||||0.0007|2-Sided|95.0|1.23|2.16|||Regression, Logistic|||Week 32, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611579|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.43||||0.0143|2-Sided|95.0|1.07|1.91|||Regression, Logistic|||Week 32, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611580|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.45||||0.0043|2-Sided|95.0|1.12|1.88|||Regression, Logistic|||Week 32, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611581|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.29||||0.0536|2-Sided|95.0|1.0|1.67|||Regression, Logistic|||Week 32, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611582|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.3||||0.0399|2-Sided|95.0|1.01|1.68|||Regression, Logistic|||Week 32, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611583|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.26||||0.0732|2-Sided|95.0|0.98|1.62|||Regression, Logistic|||Week 32, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611584|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.53|||<|0.0001|2-Sided|95.0|1.72|3.71|||Regression, Logistic|||Week 24, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611585|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.23|||<|0.0001|2-Sided|95.0|1.51|3.3|||Regression, Logistic|||Week 24, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611586|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.79|||<|0.0001|2-Sided|95.0|1.34|2.39|||Regression, Logistic|||Week 24, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611587|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.61|||<|0.0013|2-Sided|95.0|1.2|2.15|||Regression, Logistic|||Week 24, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611588|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.59|||<|0.0004|2-Sided|95.0|1.23|2.06|||Regression, Logistic|||Week 24, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611589|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.43|||<|0.0072|2-Sided|95.0|1.1|1.85|||Regression, Logistic|||Week 24, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611590|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.42|||<|0.0067|2-Sided|95.0|1.1|1.83|||Regression, Logistic|||Week 24, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611591|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.25|||<|0.089|2-Sided|95.0|0.97|1.6|||Regression, Logistic|||Week 24, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611592|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.96|||<|0.0008|2-Sided|95.0|1.32|2.9|||Regression, Logistic|||Week 16, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611593|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.21|||<|0.0001|2-Sided|95.0|1.5|3.25|||Regression, Logistic|||Week 16, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611594|NCT02528253|2960049|Superiority||Odds Ratio (OR)|0.94|||<|0.7741|2-Sided|95.0|0.6|1.46|||Regression, Logistic|||Week 16, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611595|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.84|||<|0.0059|2-Sided|95.0|1.19|2.83|||Regression, Logistic|||Week 16, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611596|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.07|||<|0.0008|2-Sided|95.0|1.35|3.17|||Regression, Logistic|||Week 16, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611597|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.86|||<|0.0001|2-Sided|95.0|1.4|2.46|||Regression, Logistic|||Week 16, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611598|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.67|||<|0.0004|2-Sided|95.0|1.26|2.22|||Regression, Logistic|||Week 16, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611599|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.09|||<|0.5701|2-Sided|95.0|0.8|1.49|||Regression, Logistic|||Week 16, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611600|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.03|||<|0.0001|2-Sided|95.0|1.48|2.79|||Regression, Logistic|||Week 16, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611601|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.82|||<|0.0002|2-Sided|95.0|1.33|2.51|||Regression, Logistic|||Week 16, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611602|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.48|||<|0.0025|2-Sided|95.0|1.15|1.91|||Regression, Logistic|||Week 16, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611603|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.38|||<|0.0124|2-Sided|95.0|1.07|1.79|||Regression, Logistic|||Week 16, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611604|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.74|||<|0.0001|2-Sided|95.0|1.31|2.31|||Regression, Logistic|||Week 16, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611605|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.63|||<|0.0007|2-Sided|95.0|1.23|2.16|||Regression, Logistic|||Week 16, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611606|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.52|||<|0.0015|2-Sided|95.0|1.17|1.96|||Regression, Logistic|||Week 16, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611607|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.28|||<|0.0575|2-Sided|95.0|0.99|1.65|||Regression, Logistic|||Week 16, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611608|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.15|||<|0.2757|2-Sided|95.0|0.89|1.48|||Regression, Logistic|||Week 16, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611609|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.74|||<|0.0001|2-Sided|95.0|1.32|2.31|||Regression, Logistic|||Week 16, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611610|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.47|||<|0.0064|2-Sided|95.0|1.12|1.95|||Regression, Logistic|||Week 16, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611611|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.33|||<|0.0001|2-Sided|95.0|1.52|3.59|||Regression, Logistic|||Week 8, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611612|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.02|||<|0.0019|2-Sided|95.0|1.3|3.14|||Regression, Logistic|||Week 8, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611613|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.33|||<|0.312|2-Sided|95.0|0.76|2.32|||Regression, Logistic|||Week 8, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611614|NCT02528253|2960049|Superiority||Odds Ratio (OR)|3.1|||<|0.0001|2-Sided|95.0|1.82|5.28|||Regression, Logistic|||Week 8, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611615|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.69|||<|0.0003|2-Sided|95.0|1.56|4.61|||Regression, Logistic|||Week 8, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611616|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.7|||<|0.0009|2-Sided|95.0|1.24|2.32|||Regression, Logistic|||Week 8, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611617|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.56|||<|0.0062|2-Sided|95.0|1.13|2.14|||Regression, Logistic|||Week 8, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611618|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.34|||<|0.118|2-Sided|95.0|0.93|1.92|||Regression, Logistic|||Week 8, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611619|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.27|||<|0.0001|2-Sided|95.0|1.57|3.28|||Regression, Logistic|||Week 8, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611620|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.08|||<|0.0001|2-Sided|95.0|1.43|3.02|||Regression, Logistic|||Week 8, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611621|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.38|||<|0.0149|2-Sided|95.0|1.07|1.8|||Regression, Logistic|||Week 8, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611622|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.16|||<|0.2857|2-Sided|95.0|0.89|1.51|||Regression, Logistic|||Week 8, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611623|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.41|||<|0.0164|2-Sided|95.0|1.06|1.86|||Regression, Logistic|||Week 8, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611624|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.95|||<|0.0001|2-Sided|95.0|1.45|2.63|||Regression, Logistic|||Week 8, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611625|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.63|||<|0.0015|2-Sided|95.0|1.2|2.2|||Regression, Logistic|||Week 8, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611626|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.4|||<|0.0092|2-Sided|95.0|1.09|1.81|||Regression, Logistic|||Week 8, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611627|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.19|||<|0.1736|2-Sided|95.0|0.93|1.54|||Regression, Logistic|||Week 8, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611628|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.33|||<|0.0273|2-Sided|95.0|1.03|1.72|||Regression, Logistic|||Week 8, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611629|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.87|||<|0.0001|2-Sided|95.0|1.41|2.47|||Regression, Logistic|||Week 8, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611630|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.59|||<|0.0011|2-Sided|95.0|1.2|2.1|||Regression, Logistic|||Week 8, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611631|NCT02528253|2960049|Superiority||Odds Ratio (OR)|3.29|||<|0.0001|2-Sided|95.0|1.87|5.78|||Regression, Logistic|||Week 4, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611632|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.68|||<|0.0009|2-Sided|95.0|1.49|4.79|||Regression, Logistic|||Week 4, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611633|NCT02528253|2960049|Superiority||Odds Ratio (OR)|0.74|||<|0.377|2-Sided|95.0|0.38|1.44|||Regression, Logistic|||Week 4, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611634|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.43|||<|0.003|2-Sided|95.0|1.35|4.38|||Regression, Logistic|||Week 4, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611635|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.98|||<|0.027|2-Sided|95.0|1.08|3.63|||Regression, Logistic|||Week 4, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611636|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.21|||<|0.0001|2-Sided|95.0|1.56|3.15|||Regression, Logistic|||Week 4, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611637|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.76|||<|0.0022|2-Sided|95.0|1.23|2.54|||Regression, Logistic|||Week 4, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611638|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.09|||<|0.6765|2-Sided|95.0|0.72|1.65|||Regression, Logistic|||Week 4, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611639|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.42|||<|0.0001|2-Sided|95.0|1.62|3.62|||Regression, Logistic|||Week 4, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611640|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.93|||<|0.0019|2-Sided|95.0|1.27|2.91|||Regression, Logistic|||Week 4, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611641|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.54|||<|0.002|2-Sided|95.0|1.17|2.04|||Regression, Logistic|||Week 4, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611642|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.33|||<|0.0459|2-Sided|95.0|1.01|1.76|||Regression, Logistic|||Week 4, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611643|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.43|||<|0.0235|2-Sided|95.0|1.05|1.95|||Regression, Logistic|||Week 4, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611644|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.21|||<|0.0001|2-Sided|95.0|1.6|3.05|||Regression, Logistic|||Week 4, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611645|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.9|||<|0.0001|2-Sided|95.0|1.37|2.64|||Regression, Logistic|||Week 4, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611646|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.56|||<|0.0007|2-Sided|95.0|1.21|2.01|||Regression, Logistic|||Week 4, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611647|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.32|||<|0.0332|2-Sided|95.0|1.02|1.71|||Regression, Logistic|||Week 4, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611648|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.25|||<|0.0963|2-Sided|95.0|0.96|1.63|||Regression, Logistic|||Week 4, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611649|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.95|||<|0.0001|2-Sided|95.0|1.47|2.59|||Regression, Logistic|||Week 4, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611650|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.65|||<|0.0006|2-Sided|95.0|1.24|2.2|||Regression, Logistic|||Week 4, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611651|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.43|||<|0.0108|2-Sided|95.0|1.23|4.81|||Regression, Logistic|||Week 2, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611652|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.89|||<|0.082|2-Sided|95.0|0.92|3.89|||Regression, Logistic|||Week 2, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611653|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.33|||<|0.5374|2-Sided|95.0|0.53|3.34|||Regression, Logistic|||Week 2, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611654|NCT02528253|2960049|Superiority||Odds Ratio (OR)|3.24|||<|0.0075|2-Sided|95.0|1.37|7.69|||Regression, Logistic|||Week 2, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611655|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.53|||<|0.0416|2-Sided|95.0|1.04|6.17|||Regression, Logistic|||Week 2, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611656|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.64|||<|0.0335|2-Sided|95.0|1.04|2.57|||Regression, Logistic|||Week 2, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611657|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.71|||<|0.0202|2-Sided|95.0|1.09|2.68|||Regression, Logistic|||Week 2, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611658|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.17|||<|0.5599|2-Sided|95.0|0.69|1.99|||Regression, Logistic|||Week 2, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611659|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.91|||<|0.0162|2-Sided|95.0|1.13|3.25|||Regression, Logistic|||Week 2, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611660|NCT02528253|2960049|Superiority||Odds Ratio (OR)|2.0|||<|0.0101|2-Sided|95.0|1.18|3.39|||Regression, Logistic|||Week 2, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611661|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.35|||<|0.0667|2-Sided|95.0|0.98|1.86|||Regression, Logistic|||Week 2, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611662|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.24|||<|0.1863|2-Sided|95.0|0.9|1.72|||Regression, Logistic|||Week 2, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611663|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.3|||<|0.1528|2-Sided|95.0|0.91|1.85|||Regression, Logistic|||Week 2, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611664|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.75|||<|0.0032|2-Sided|95.0|1.21|2.54|||Regression, Logistic|||Week 2, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611665|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.61|||<|0.0125|2-Sided|95.0|1.11|2.35|||Regression, Logistic|||Week 2, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611666|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.52|||<|0.0022|2-Sided|95.0|1.16|1.98|||Regression, Logistic|||Week 2, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611667|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.17|||<|0.2655|2-Sided|95.0|0.89|1.54|||Regression, Logistic|||Week 2, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611668|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.31|||<|0.07|2-Sided|95.0|0.98|1.74|||Regression, Logistic|||Week 2, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611669|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.98|||<|0.0001|2-Sided|95.0|1.46|2.69|||Regression, Logistic|||Week 2, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611670|NCT02528253|2960049|Superiority||Odds Ratio (OR)|1.53|||<|0.0076|2-Sided|95.0|1.12|2.08|||Regression, Logistic|||Week 2, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline RMDQ, baseline average LBPI and treatment.|
1611671|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.13||||0.5673|2-Sided|95.0|0.74|1.72|||Regression, Logistic|||Week 56, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611672|NCT02528253|2960050|Superiority||Odds Ratio (OR)|0.95||||0.8266|2-Sided|95.0|0.61|1.48|||Regression, Logistic|||Week 56, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611673|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.25||||0.125|2-Sided|95.0|0.94|1.67|||Regression, Logistic|||Week 56, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611674|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.22||||0.184|2-Sided|95.0|0.91|1.62|||Regression, Logistic|||Week 56, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611675|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.31||||0.0358|2-Sided|95.0|1.02|1.7|||Regression, Logistic|||Week 56, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611676|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.13||||0.3531|2-Sided|95.0|0.87|1.46|||Regression, Logistic|||Week 56, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611677|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.33||||0.0256|2-Sided|95.0|1.04|1.72|||Regression, Logistic|||Week 56, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611678|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.17||||0.2137|2-Sided|95.0|0.91|1.51|||Regression, Logistic|||Week 56, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611679|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.38||||0.1338|2-Sided|95.0|0.91|2.11|||Regression, Logistic|||Week 48, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611680|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.14||||0.5635|2-Sided|95.0|0.73|1.77|||Regression, Logistic|||Week 48, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611681|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.18||||0.2601|2-Sided|95.0|0.88|1.58|||Regression, Logistic|||Week 48, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611682|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.21||||0.2025|2-Sided|95.0|0.9|1.61|||Regression, Logistic|||Week 48, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611683|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.28||||0.0619|2-Sided|95.0|0.99|1.65|||Regression, Logistic|||Week 48, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611684|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.2||||0.1647|2-Sided|95.0|0.93|1.55|||Regression, Logistic|||Week 48, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611685|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.19||||0.1741|2-Sided|95.0|0.93|1.53|||Regression, Logistic|||Week 48, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611686|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.16||||0.256|2-Sided|95.0|0.9|1.49|||Regression, Logistic|||Week 48, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611687|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.55||||0.0447|2-Sided|95.0|1.01|2.39|||Regression, Logistic|||Week 40, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611688|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.29||||0.2628|2-Sided|95.0|0.83|2.02|||Regression, Logistic|||Week 40, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611689|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.23||||0.1608|2-Sided|95.0|0.92|1.63|||Regression, Logistic|||Week 40, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611690|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.12||||0.4418|2-Sided|95.0|0.84|1.5|||Regression, Logistic|||Week 40, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611691|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.24||||0.1032|2-Sided|95.0|0.96|1.59|||Regression, Logistic|||Week 40, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611692|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.15||||0.2773|2-Sided|95.0|0.89|1.49|||Regression, Logistic|||Week 40, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611693|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.2||||0.1579|2-Sided|95.0|0.93|1.54|||Regression, Logistic|||Week 40, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611694|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.16||||0.2622|2-Sided|95.0|0.9|1.49|||Regression, Logistic|||Week 40, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611695|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.36||||0.1848|2-Sided|95.0|0.86|2.13|||Regression, Logistic|||Week 32, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611696|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.06||||0.8122|2-Sided|95.0|0.66|1.71|||Regression, Logistic|||Week 32, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611697|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.19||||0.2515|2-Sided|95.0|0.89|1.59|||Regression, Logistic|||Week 32, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611698|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.28||||0.0964|2-Sided|95.0|0.96|1.71|||Regression, Logistic|||Week 32, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611699|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.31||||0.0365|2-Sided|95.0|1.02|1.69|||Regression, Logistic|||Week 32, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611700|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.22||||0.1206|2-Sided|95.0|0.95|1.58|||Regression, Logistic|||Week 32, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611701|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.33||||0.0274|2-Sided|95.0|1.03|1.71|||Regression, Logistic|||Week 32, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611702|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.28||||0.0562|2-Sided|95.0|0.99|1.65|||Regression, Logistic|||Week 32, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611703|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.09||||0.7433|2-Sided|95.0|0.66|1.78|||Regression, Logistic|||Week 24, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611704|NCT02528253|2960050|Superiority||Odds Ratio (OR)|0.93||||0.7696|2-Sided|95.0|0.55|1.55|||Regression, Logistic|||Week 24, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611705|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.22||||0.1768|2-Sided|95.0|0.91|1.62|||Regression, Logistic|||Week 24, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611706|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.03||||0.8641|2-Sided|95.0|0.76|1.38|||Regression, Logistic|||Week 24, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611707|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.36||||0.017|2-Sided|95.0|1.06|1.75|||Regression, Logistic|||Week 24, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611708|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.13||||0.3557|2-Sided|95.0|0.87|1.45|||Regression, Logistic|||Week 24, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611709|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.42||||0.0074|2-Sided|95.0|1.1|1.83|||Regression, Logistic|||Week 24, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611710|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.18||||0.1996|2-Sided|95.0|0.92|1.52|||Regression, Logistic|||Week 24, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611711|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.06||||0.8165|2-Sided|95.0|0.64|1.77|||Regression, Logistic|||Week 16, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611712|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.18||||0.5027|2-Sided|95.0|0.72|1.95|||Regression, Logistic|||Week 16, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611713|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.17||||0.5798|2-Sided|95.0|0.68|2.0|||Regression, Logistic|||Week 16, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611714|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.24||||0.4717|2-Sided|95.0|0.69|2.21|||Regression, Logistic|||Week 16, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611715|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.38||||0.2661|2-Sided|95.0|0.78|2.44|||Regression, Logistic|||Week 16, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611716|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.33||||0.0638|2-Sided|95.0|0.98|1.79|||Regression, Logistic|||Week 16, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611717|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.09||||0.5954|2-Sided|95.0|0.8|1.48|||Regression, Logistic|||Week 16, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611718|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.11||||0.5212|2-Sided|95.0|0.81|1.53|||Regression, Logistic|||Week 16, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611719|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.47||||0.0238|2-Sided|95.0|1.05|2.07|||Regression, Logistic|||Week 16, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1614329|NCT02494401|2963012|Superiority|||||||0.89||||||p value baseline comparison|Wilcoxon (Mann-Whitney)||||
1611720|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.21||||0.2839|2-Sided|95.0|0.86|1.7|||Regression, Logistic|||Week 16, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611721|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.15||||0.2734|2-Sided|95.0|0.89|1.48|||Regression, Logistic|||Week 16, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611722|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.02||||0.8732|2-Sided|95.0|0.79|1.32|||Regression, Logistic|||Week 16, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611723|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.25||||0.0848|2-Sided|95.0|0.97|1.62|||Regression, Logistic|||Week 16, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611724|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.45||||0.0101|2-Sided|95.0|1.09|1.91|||Regression, Logistic|||Week 16, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611725|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.28||||0.0846|2-Sided|95.0|0.97|1.7|||Regression, Logistic|||Week 16, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611726|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.38||||0.0144|2-Sided|95.0|1.07|1.8|||Regression, Logistic|||Week 16, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611727|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.34||||0.0269|2-Sided|95.0|1.03|1.74|||Regression, Logistic|||Week 16, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611728|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.08||||0.5493|2-Sided|95.0|0.84|1.39|||Regression, Logistic|||Week 16, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611729|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.5||||0.0054|2-Sided|95.0|1.13|1.99|||Regression, Logistic|||Week 16, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611730|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.45||||0.0101|2-Sided|95.0|1.09|1.92|||Regression, Logistic|||Week 16, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611731|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.31||||0.2768|2-Sided|95.0|0.8|2.15|||Regression, Logistic|||Week 12, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611732|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.27||||0.3498|2-Sided|95.0|0.77|2.08|||Regression, Logistic|||Week 12, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611733|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.25||||0.4317|2-Sided|95.0|0.72|2.19|||Regression, Logistic|||Week 12, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611734|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.64||||0.0913|2-Sided|95.0|0.92|2.92|||Regression, Logistic|||Week 12, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611735|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.58||||0.1197|2-Sided|95.0|0.89|2.83|||Regression, Logistic|||Week 12, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611736|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.49||||0.0088|2-Sided|95.0|1.11|2.01|||Regression, Logistic|||Week 12, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611737|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.02||||0.9177|2-Sided|95.0|0.74|1.4|||Regression, Logistic|||Week 12, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611738|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.38||||0.0653|2-Sided|95.0|0.98|1.94|||Regression, Logistic|||Week 12, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611739|NCT02528253|2960050|Superiority||Odds Ratio (OR)|2.06|||<|0.0001|2-Sided|95.0|1.45|2.92|||Regression, Logistic|||Week 12, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611740|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.4|||<|0.0723|2-Sided|95.0|0.97|2.02|||Regression, Logistic|||Week 12, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611741|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.45|||<|0.004|2-Sided|95.0|1.13|1.87|||Regression, Logistic|||Week 12, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611742|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.17|||<|0.2358|2-Sided|95.0|0.9|1.51|||Regression, Logistic|||Week 12, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611743|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.16|||<|0.2561|2-Sided|95.0|0.9|1.51|||Regression, Logistic|||Week 12, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611744|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.69|||<|0.0003|2-Sided|95.0|1.27|2.24|||Regression, Logistic|||Week 12, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611745|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.36|||<|0.0342|2-Sided|95.0|1.02|1.81|||Regression, Logistic|||Week 12, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1614561|NCT02485561|2963723|Superiority||F-value|0.608||||0.55|2-Sided||||||ANOVA||||
1611746|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.52|||<|0.0018|2-Sided|95.0|1.17|1.97|||Regression, Logistic|||Week 12, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611747|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.21|||<|0.137|2-Sided|95.0|0.94|1.57|||Regression, Logistic|||Week 12, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611748|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.14|||<|0.315|2-Sided|95.0|0.88|1.47|||Regression, Logistic|||Week 12, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611749|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.73|||<|0.0002|2-Sided|95.0|1.3|2.3|||Regression, Logistic|||Week 12, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611750|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.38|||<|0.0229|2-Sided|95.0|1.05|1.83|||Regression, Logistic|||Week 12, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611751|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.17|||<|0.6199|2-Sided|95.0|0.62|2.2|||Regression, Logistic|||Week 8, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611752|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.16|||<|0.6402|2-Sided|95.0|0.62|2.18|||Regression, Logistic|||Week 8, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611753|NCT02528253|2960050|Superiority||Odds Ratio (OR)|0.96|||<|0.9029|2-Sided|95.0|0.5|1.84|||Regression, Logistic|||Week 8, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611754|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.13|||<|0.7347|2-Sided|95.0|0.57|2.24|||Regression, Logistic|||Week 8, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611755|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.12|||<|0.7546|2-Sided|95.0|0.56|2.22|||Regression, Logistic|||Week 8, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611756|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.67|||<|0.0022|2-Sided|95.0|1.2|2.32|||Regression, Logistic|||Week 8, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611757|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.08|||<|0.6706|2-Sided|95.0|0.76|1.54|||Regression, Logistic|||Week 8, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611758|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.36|||<|0.121|2-Sided|95.0|0.92|2.0|||Regression, Logistic|||Week 8, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611759|NCT02528253|2960050|Superiority||Odds Ratio (OR)|2.27|||<|0.0001|2-Sided|95.0|1.53|3.36|||Regression, Logistic|||Week 8, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611760|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.47|||<|0.0694|2-Sided|95.0|0.97|2.22|||Regression, Logistic|||Week 8, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611761|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.43|||<|0.0072|2-Sided|95.0|1.1|1.86|||Regression, Logistic|||Week 8, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611762|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.19|||<|0.2076|2-Sided|95.0|0.91|1.55|||Regression, Logistic|||Week 8, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611763|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.48|||<|0.0069|2-Sided|95.0|1.11|1.97|||Regression, Logistic|||Week 8, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611764|NCT02528253|2960050|Superiority||Odds Ratio (OR)|2.12|||<|0.0001|2-Sided|95.0|1.57|2.87|||Regression, Logistic|||Week 8, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611765|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.76|||<|0.0003|2-Sided|95.0|1.3|2.39|||Regression, Logistic|||Week 8, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611766|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.39|||<|0.011|2-Sided|95.0|1.08|1.79|||Regression, Logistic|||Week 8, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611767|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.22|||<|0.1187|2-Sided|95.0|0.95|1.57|||Regression, Logistic|||Week 8, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611768|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.42|||<|0.0071|2-Sided|95.0|1.1|1.83|||Regression, Logistic|||Week 8, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611769|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.97|||<|0.0001|2-Sided|95.0|1.49|2.61|||Regression, Logistic|||Week 8, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611770|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.73|||<|0.0001|2-Sided|95.0|1.31|2.29|||Regression, Logistic|||Week 8, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611771|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.51|||<|0.2682|2-Sided|95.0|0.73|3.12|||Regression, Logistic|||Week 4, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1615063|NCT02473471|2964571|Other|||||||0.29|||||||t-test, 2 sided|||Day 3|
1611772|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.09|||<|0.8331|2-Sided|95.0|0.49|2.4|||Regression, Logistic|||Week 4, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611773|NCT02528253|2960050|Superiority||Odds Ratio (OR)|0.91|||<|0.814|2-Sided|95.0|0.41|2.0|||Regression, Logistic|||Week 4, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611774|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.37|||<|0.4333|2-Sided|95.0|0.62|3.02|||Regression, Logistic|||Week 4, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611775|NCT02528253|2960050|Superiority||Odds Ratio (OR)|0.99|||<|0.9819|2-Sided|95.0|0.42|2.31|||Regression, Logistic|||Week 4, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611776|NCT02528253|2960050|Superiority||Odds Ratio (OR)|2.16|||<|0.0001|2-Sided|95.0|1.48|3.14|||Regression, Logistic|||Week 4, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611777|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.46|||<|0.0642|2-Sided|95.0|0.98|2.19|||Regression, Logistic|||Week 4, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611778|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.25|||<|0.3485|2-Sided|95.0|0.79|1.99|||Regression, Logistic|||Week 4, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611779|NCT02528253|2960050|Superiority||Odds Ratio (OR)|2.69|||<|0.0001|2-Sided|95.0|1.71|4.22|||Regression, Logistic|||Week 4, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611780|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.83|||<|0.0126|2-Sided|95.0|1.14|2.93|||Regression, Logistic|||Week 4, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611781|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.49|||<|0.0057|2-Sided|95.0|1.12|1.98|||Regression, Logistic|||Week 4, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611782|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.19|||<|0.2504|2-Sided|95.0|0.89|1.59|||Regression, Logistic|||Week 4, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611783|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.27|||<|0.1389|2-Sided|95.0|0.93|1.73|||Regression, Logistic|||Week 4, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611784|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.89|||<|0.0001|2-Sided|95.0|1.36|2.62|||Regression, Logistic|||Week 4, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611785|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.5|||<|0.0166|2-Sided|95.0|1.08|2.09|||Regression, Logistic|||Week 4, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611786|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.56|||<|0.0006|2-Sided|95.0|1.21|2.01|||Regression, Logistic|||Week 4, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611787|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.24|||<|0.0903|2-Sided|95.0|0.97|1.6|||Regression, Logistic|||Week 4, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611788|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.32|||<|0.0387|2-Sided|95.0|1.01|1.71|||Regression, Logistic|||Week 4, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611789|NCT02528253|2960050|Superiority||Odds Ratio (OR)|2.05|||<|0.0001|2-Sided|95.0|1.55|2.72|||Regression, Logistic|||Week 4, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611790|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.64|||<|0.0006|2-Sided|95.0|1.23|2.17|||Regression, Logistic|||Week 4, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611791|NCT02528253|2960050|Superiority||Odds Ratio (OR)|2.1|||<|0.2065|2-Sided|95.0|0.66|6.68|||Regression, Logistic|||Week 2, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611792|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.19|||<|0.795|2-Sided|95.0|0.32|4.46|||Regression, Logistic|||Week 2, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611793|NCT02528253|2960050|Superiority||Odds Ratio (OR)|0.83|||<|0.7874|2-Sided|95.0|0.22|3.12|||Regression, Logistic|||Week 2, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611794|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.75|||<|0.3726|2-Sided|95.0|0.51|6.04|||Regression, Logistic|||Week 2, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611795|NCT02528253|2960050|Superiority||Odds Ratio (OR)|0.99|||<|0.9926|2-Sided|95.0|0.25|4.0|||Regression, Logistic|||Week 2, >=90%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611796|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.76|||<|0.072|2-Sided|95.0|0.95|3.24|||Regression, Logistic|||Week 2, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611797|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.59|||<|0.1492|2-Sided|95.0|0.85|2.96|||Regression, Logistic|||Week 2, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1615064|NCT02473471|2964571|Other|||||||0.09|||||||t-test, 2 sided|||Day 1|
1611798|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.22|||<|0.5966|2-Sided|95.0|0.58|2.58|||Regression, Logistic|||Week 2, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611799|NCT02528253|2960050|Superiority||Odds Ratio (OR)|2.15|||<|0.0407|2-Sided|95.0|1.03|4.47|||Regression, Logistic|||Week 2, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611800|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.94|||<|0.0806|2-Sided|95.0|0.92|4.08|||Regression, Logistic|||Week 2, >=70%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611801|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.37|||<|0.0974|2-Sided|95.0|0.94|1.99|||Regression, Logistic|||Week 2, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611802|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.19|||<|0.3746|2-Sided|95.0|0.81|1.75|||Regression, Logistic|||Week 2, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611803|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.29|||<|0.236|2-Sided|95.0|0.85|1.98|||Regression, Logistic|||Week 2, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611804|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.77|||<|0.0105|2-Sided|95.0|1.14|2.75|||Regression, Logistic|||Week 2, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611805|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.54|||<|0.0594|2-Sided|95.0|0.98|2.41|||Regression, Logistic|||Week 2, >=50%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611806|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.16|||<|0.2771|2-Sided|95.0|0.89|1.53|||Regression, Logistic|||Week 2, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611807|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.14|||<|0.3456|2-Sided|95.0|0.87|1.5|||Regression, Logistic|||Week 2, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611808|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.77|||<|0.0004|2-Sided|95.0|1.29|2.44|||Regression, Logistic|||Week 2, >=30%: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611809|NCT02528253|2960050|Superiority||Odds Ratio (OR)|1.74|||<|0.0007|2-Sided|95.0|1.26|2.39|||Regression, Logistic|||Week 2, >=30%: Odds ratio (OR) and 95% Confidence interval (CI) estimated from logistic regression model. Logistic regression model included baseline average LBPI and treatment.|
1611810|NCT02528253|2960053|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.08||0.3634|2-Sided|95.0|-0.23|0.09|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611811|NCT02528253|2960053|Superiority||LS Mean Difference|-0.1|Standard Error of the Mean|0.08||0.2346|2-Sided|95.0|-0.25|0.06|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611812|NCT02528253|2960053|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.08||0.5173|2-Sided|95.0|-0.21|0.1|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611813|NCT02528253|2960053|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.08||0.3329|2-Sided|95.0|-0.23|0.08|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611814|NCT02528253|2960053|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.08||0.521|2-Sided|95.0|-0.2|0.1|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611815|NCT02528253|2960053|Superiority||LS Mean Difference|-0.1|Standard Error of the Mean|0.08||0.1884|2-Sided|95.0|-0.25|0.05|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611816|NCT02528253|2960053|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.07||0.4946|2-Sided|95.0|-0.2|0.09|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611817|NCT02528253|2960053|Superiority||LS Mean Difference|-0.06|Standard Error of the Mean|0.07||0.433|2-Sided|95.0|-0.21|0.09|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611818|NCT02528253|2960053|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.07||0.278|2-Sided|95.0|-0.22|0.06|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1612423|NCT02527161|2960184|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in KOOS Sports score from preoperative to 12 months.|
1611819|NCT02528253|2960053|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.07||0.1974|2-Sided|95.0|-0.24|0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611820|NCT02528253|2960053|Superiority||LS Mean Difference|-0.17|Standard Error of the Mean|0.06||0.006|2-Sided|95.0|-0.29|-0.05|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611821|NCT02528253|2960053|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.06||0.0299|2-Sided|95.0|-0.25|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611822|NCT02528253|2960053|Superiority||LS Mean Difference|0.01|Standard Error of the Mean|0.06||0.8399|2-Sided|95.0|-0.11|0.13|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611823|NCT02528253|2960053|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.07||0.0207|2-Sided|95.0|-0.29|-0.02|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611824|NCT02528253|2960053|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.07||0.0717|2-Sided|95.0|-0.25|0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611825|NCT02528253|2960053|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.05||0.0219|2-Sided|95.0|-0.23|-0.02|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611826|NCT02528253|2960053|Superiority||LS Mean Difference|-0.06|Standard Error of the Mean|0.05||0.2968|2-Sided|95.0|-0.16|0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611827|NCT02528253|2960053|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.05||0.168|2-Sided|95.0|-0.18|0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611828|NCT02528253|2960053|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.06||0.0009|2-Sided|95.0|-0.31|-0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611829|NCT02528253|2960053|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.06||0.0272|2-Sided|95.0|-0.25|-0.01|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611830|NCT02528253|2960053|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.05||0.0001|2-Sided|95.0|-0.3|-0.1|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611831|NCT02528253|2960053|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.05||0.002|2-Sided|95.0|-0.26|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611832|NCT02528253|2960053|Superiority||LS Mean Difference|-0.01|Standard Error of the Mean|0.05||0.8348|2-Sided|95.0|-0.11|0.09|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611833|NCT02528253|2960053|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.06||0.0002|2-Sided|95.0|-0.32|-0.1|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611834|NCT02528253|2960053|Superiority||LS Mean Difference|-0.17|Standard Error of the Mean|0.06||0.0025|2-Sided|95.0|-0.28|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611835|NCT02528253|2960053|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.05||0.0044|2-Sided|95.0|-0.23|-0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1612424|NCT02527161|2960184|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in KOOS ADL score from preoperative to 12 months.|
1611836|NCT02528253|2960053|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.05||0.0893|2-Sided|95.0|-0.18|0.01|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611837|NCT02528253|2960053|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.05||0.0135|2-Sided|95.0|-0.24|-0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611838|NCT02528253|2960053|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.05||0.1472|2-Sided|95.0|-0.18|0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline PGA, and baseline average LBPI as covariates, and study site as a random effect.|
1611839|NCT02528253|2960055|Superiority||LS Mean Difference|-0.83|Standard Error of the Mean|0.52||0.1089|2-Sided|95.0|-1.84|0.18|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611840|NCT02528253|2960055|Superiority||LS Mean Difference|-0.44|Standard Error of the Mean|0.52||0.3981|2-Sided|95.0|-1.47|0.58|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611841|NCT02528253|2960055|Superiority||LS Mean Difference|-0.7|Standard Error of the Mean|0.52||0.1782|2-Sided|95.0|-1.71|0.32|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611842|NCT02528253|2960055|Superiority||LS Mean Difference|-0.47|Standard Error of the Mean|0.52||0.3654|2-Sided|95.0|-1.5|0.55|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611843|NCT02528253|2960055|Superiority||LS Mean Difference|-0.71|Standard Error of the Mean|0.51||0.1605|2-Sided|95.0|-1.71|0.28|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611844|NCT02528253|2960055|Superiority||LS Mean Difference|-0.59|Standard Error of the Mean|0.51||0.248|2-Sided|95.0|-1.6|0.41|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611845|NCT02528253|2960055|Superiority||LS Mean Difference|-0.97|Standard Error of the Mean|0.5||0.0507|2-Sided|95.0|-1.94|0.0|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611846|NCT02528253|2960055|Superiority||LS Mean Difference|-0.72|Standard Error of the Mean|0.5||0.1485|2-Sided|95.0|-1.7|0.26|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611847|NCT02528253|2960055|Superiority||LS Mean Difference|-1.33|Standard Error of the Mean|0.49||0.0068|2-Sided|95.0|-2.3|-0.37|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611848|NCT02528253|2960055|Superiority||LS Mean Difference|-0.98|Standard Error of the Mean|0.49||0.0464|2-Sided|95.0|-1.94|-0.02|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611849|NCT02528253|2960055|Superiority||LS Mean Difference|-1.48|Standard Error of the Mean|0.42||0.0004|2-Sided|95.0|-2.29|-0.66|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611850|NCT02528253|2960055|Superiority||LS Mean Difference|-1.06|Standard Error of the Mean|0.42||0.0107|2-Sided|95.0|-1.87|-0.25|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611851|NCT02528253|2960055|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.42||0.5412|2-Sided|95.0|-1.09|0.57|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611852|NCT02528253|2960055|Superiority||LS Mean Difference|-1.74|Standard Error of the Mean|0.46||0.0002|2-Sided|95.0|-2.64|-0.83|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1612425|NCT02527161|2960184|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in KOOS Symptoms score from preoperative to 12 months.|
1611853|NCT02528253|2960055|Superiority||LS Mean Difference|-1.32|Standard Error of the Mean|0.45||0.0035|2-Sided|95.0|-2.21|-0.43|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611854|NCT02528253|2960055|Superiority||LS Mean Difference|-1.34|Standard Error of the Mean|0.37||0.0003|2-Sided|95.0|-2.06|-0.61|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611855|NCT02528253|2960055|Superiority||LS Mean Difference|-0.76|Standard Error of the Mean|0.37||0.0385|2-Sided|95.0|-1.47|-0.04|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611856|NCT02528253|2960055|Superiority||LS Mean Difference|-1.95|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|-2.73|-1.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611857|NCT02528253|2960055|Superiority||LS Mean Difference|-1.37|Standard Error of the Mean|0.4|<|0.0006|2-Sided|95.0|-2.15|-0.58|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611858|NCT02528253|2960055|Superiority||LS Mean Difference|-1.65|Standard Error of the Mean|0.35|<|0.0001|2-Sided|95.0|-2.34|-0.97|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611859|NCT02528253|2960055|Superiority||LS Mean Difference|-0.92|Standard Error of the Mean|0.35|<|0.0082|2-Sided|95.0|-1.6|-0.24|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611860|NCT02528253|2960055|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.35|<|0.3906|2-Sided|95.0|-0.99|0.39|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611861|NCT02528253|2960055|Superiority||LS Mean Difference|-1.96|Standard Error of the Mean|0.38|<|0.0001|2-Sided|95.0|-2.7|-1.21|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611862|NCT02528253|2960055|Superiority||LS Mean Difference|-1.22|Standard Error of the Mean|0.38|<|0.0013|2-Sided|95.0|-1.96|-0.48|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611863|NCT02528253|2960055|Superiority||LS Mean Difference|-1.1|Standard Error of the Mean|0.31|<|0.0004|2-Sided|95.0|-1.7|-0.5|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611864|NCT02528253|2960055|Superiority||LS Mean Difference|-0.56|Standard Error of the Mean|0.3|<|0.0658|2-Sided|95.0|-1.16|0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611865|NCT02528253|2960055|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.31|<|0.3697|2-Sided|95.0|-0.89|0.33|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611866|NCT02528253|2960055|Superiority||LS Mean Difference|-1.38|Standard Error of the Mean|0.34|<|0.0001|2-Sided|95.0|-2.05|-0.71|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611867|NCT02528253|2960055|Superiority||LS Mean Difference|-0.84|Standard Error of the Mean|0.34|<|0.0121|2-Sided|95.0|-1.5|-0.18|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611868|NCT02528253|2960057|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.2||0.2887|2-Sided|95.0|-0.61|0.18|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611869|NCT02528253|2960057|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.2||0.5763|2-Sided|95.0|-0.51|0.28|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1612360|NCT02528188|2960145|Superiority||LS Mean Difference|0.05|Standard Error of the Mean|0.12||0.7109|2-Sided|95.0|-0.19|0.28|||ANCOVA|||Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.|
1611870|NCT02528253|2960057|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.2||0.3205|2-Sided|95.0|-0.58|0.19|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611871|NCT02528253|2960057|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.2||0.4403|2-Sided|95.0|-0.53|0.23|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611872|NCT02528253|2960057|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.2||0.3523|2-Sided|95.0|-0.56|0.2|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611873|NCT02528253|2960057|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.2||0.4561|2-Sided|95.0|-0.54|0.24|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611874|NCT02528253|2960057|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.2||0.2428|2-Sided|95.0|-0.62|0.16|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611875|NCT02528253|2960057|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.19||0.2431|2-Sided|95.0|-0.6|0.15|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611876|NCT02528253|2960057|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.19||0.1488|2-Sided|95.0|-0.66|0.1|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611877|NCT02528253|2960057|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.19||0.5164|2-Sided|95.0|-0.5|0.25|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611878|NCT02528253|2960057|Superiority||LS Mean Difference|-0.38|Standard Error of the Mean|0.16||0.0152|2-Sided|95.0|-0.68|-0.07|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611879|NCT02528253|2960057|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.16||0.2656|2-Sided|95.0|-0.48|0.13|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611880|NCT02528253|2960057|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.16||0.2103|2-Sided|95.0|-0.51|0.11|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611881|NCT02528253|2960057|Superiority||LS Mean Difference|-0.58|Standard Error of the Mean|0.17||0.0009|2-Sided|95.0|-0.91|-0.24|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611882|NCT02528253|2960057|Superiority||LS Mean Difference|-0.37|Standard Error of the Mean|0.17||0.0307|2-Sided|95.0|-0.71|-0.03|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611883|NCT02528253|2960057|Superiority||LS Mean Difference|-0.37|Standard Error of the Mean|0.15||0.0123|2-Sided|95.0|-0.65|-0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611884|NCT02528253|2960057|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.15||0.1495|2-Sided|95.0|-0.5|0.08|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611885|NCT02528253|2960057|Superiority||LS Mean Difference|-0.32|Standard Error of the Mean|0.15||0.0274|2-Sided|95.0|-0.61|-0.04|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611886|NCT02528253|2960057|Superiority||LS Mean Difference|-0.69|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.0|-0.38|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611887|NCT02528253|2960057|Superiority||LS Mean Difference|-0.53|Standard Error of the Mean|0.16|<|0.0008|2-Sided|95.0|-0.84|-0.22|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611888|NCT02528253|2960057|Superiority||LS Mean Difference|-0.44|Standard Error of the Mean|0.13|<|0.0009|2-Sided|95.0|-0.7|-0.18|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611889|NCT02528253|2960057|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.13|<|0.0661|2-Sided|95.0|-0.5|0.02|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611890|NCT02528253|2960057|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.13|<|0.0711|2-Sided|95.0|-0.5|0.02|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611891|NCT02528253|2960057|Superiority||LS Mean Difference|-0.68|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-0.96|-0.39|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611892|NCT02528253|2960057|Superiority||LS Mean Difference|-0.48|Standard Error of the Mean|0.14|<|0.0008|2-Sided|95.0|-0.76|-0.2|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611893|NCT02528253|2960057|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.11|<|0.037|2-Sided|95.0|-0.44|-0.01|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611894|NCT02528253|2960057|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.11|<|0.0959|2-Sided|95.0|-0.39|0.03|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611895|NCT02528253|2960057|Superiority||LS Mean Difference|-0.42|Standard Error of the Mean|0.12|<|0.0004|2-Sided|95.0|-0.65|-0.19|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611896|NCT02528253|2960057|Superiority||LS Mean Difference|-0.37|Standard Error of the Mean|0.12|<|0.0015|2-Sided|95.0|-0.6|-0.14|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611897|NCT02528253|2960058|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.17||0.0958|2-Sided|95.0|-0.6|0.05|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611898|NCT02528253|2960058|Superiority||LS Mean Difference|-0.17|Standard Error of the Mean|0.17||0.3118|2-Sided|95.0|-0.5|0.16|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline average LBPI as a covariates, and study site as a random effect.|
1611899|NCT02528253|2960059|Superiority||LS Mean Difference|-1.74|Standard Error of the Mean|0.46||0.0002|2-Sided|95.0|-2.64|-0.83|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611900|NCT02528253|2960059|Superiority||LS Mean Difference|-1.32|Standard Error of the Mean|0.45||0.0035|2-Sided|95.0|-2.21|-0.43|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as fixed effects, baseline RMDQ, and baseline average LBPI as covariates, and study site as a random effect.|
1611901|NCT02528253|2960060|Superiority||LS Mean Difference|-0.4|Standard Error of the Mean|0.18||0.0281|2-Sided|95.0|-0.76|-0.04|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.|
1611902|NCT02528253|2960060|Superiority||Least Square (LS) Mean Difference|-0.3|Standard Error of the Mean|0.19||0.1117|2-Sided|95.0|-0.66|0.07|||ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment as a fixed effect, and baseline LBPI as a covariates, and study site as a random effect.|
1611903|NCT02528214|2960069|Superiority|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|2.74||||0.0015|2-Sided|95.0|1.47|5.1||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant no longer required OCS at Week 24 as the response variable, and treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed using a pattern mixture model by multiple imputation approach.|
1611921|NCT02528188|2960101|Superiority||LS Mean Ratio|0.7|Standard Error of the Mean|0.13||0.0595|2-Sided|95.0|0.49|1.01|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1612426|NCT02527161|2960184|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in KOOS Pain Score from preoperative to 12 months|
1611904|NCT02528214|2960070|Superiority|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|2.57||||0.0024|2-Sided|95.0|1.4|4.73||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome was analyzed using a logistic regression model. The model included binary status of whether or not a participant achieved their maximum possible reduction of OCS dose per protocol at Week 24 as the response variable, treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.|
1611905|NCT02528214|2960071|Superiority|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|4.48|||<|0.0001|2-Sided|95.0|2.39|8.39||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant achieved a reduction of OCS dose to <5 mg/day at Week 24 as the response variable, treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.|
1611906|NCT02528214|2960072|Superiority|Testing was performed according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant).|Odds Ratio (OR)|3.98|||<|0.0001|2-Sided|95.0|2.06|7.67||Threshold for significance at 0.05.|Regression, Logistic||Dupilumab 300 mg q2w v Placebo q2w|The outcome measure was analyzed using a logistic regression model. The model included the binary status of whether or not a participant achieved the 50% OCS dose reduction criterion as the response variable, and treatment groups, optimized OCS dose at baseline, regions, and baseline eosinophil level subgroups as covariates. Missing data was imputed by using a pattern mixture model by multiple imputation approach.|
1611907|NCT02528214|2960074|Superiority|A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measure are reported and continued when previous outcome measure was statistically significant at two-sided 0.05. Only the primary and the first 4 secondary outcome measures were included in the procedure.|Least Square (LS) Mean Difference|28.24|||<|0.0001|2-Sided|95.0|15.81|40.67||Threshold for significance at two-sided 0.05 level.|ANCOVA||LS mean difference represents reduction difference i.e. dupilumab - placebo.|The outcome measure was analyzed using analysis of covariance (ANCOVA) model which included percentage reduction of OCS dose at Week 24 as the response variable, and treatment group, baseline eosinophil level, optimized OCS dose at baseline, region as covariates. Missing data was imputed using a pattern mixture model by multiple imputation approach.|
1611908|NCT02528188|2960092|Superiority|||||||0.1545|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611909|NCT02528188|2960092|Superiority|||||||0.7284|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611910|NCT02528188|2960092|Superiority|||||||0.819|||||||Cochran-Mantel-Haenszel|||Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611911|NCT02528188|2960092|Superiority|||||||0.9867|||||||Cochran-Mantel-Haenszel|||Week 24: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611912|NCT02528188|2960092|Superiority|||||||0.6627|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611913|NCT02528188|2960092|Superiority|||||||0.7857|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611914|NCT02528188|2960092|Superiority|||||||0.7969|||||||Cochran-Mantel-Haenszel|||Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611915|NCT02528188|2960092|Superiority|||||||0.7204|||||||Cochran-Mantel-Haenszel|||Week 8: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611916|NCT02528188|2960092|Superiority|||||||0.1928|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611917|NCT02528188|2960092|Superiority|||||||0.6037|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611918|NCT02528188|2960101|Superiority||LS Mean Ratio|0.68|Standard Error of the Mean|0.14||0.0709|2-Sided|95.0|0.45|1.03|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611919|NCT02528188|2960101|Superiority||LS Mean Ratio|0.73|Standard Error of the Mean|0.15||0.1389|2-Sided|95.0|0.48|1.11|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611920|NCT02528188|2960101|Superiority||LS Mean Ratio|0.57|Standard Error of the Mean|0.11||0.003|2-Sided|95.0|0.4|0.83|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1612361|NCT02528188|2960145|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.12||0.4406|2-Sided|95.0|-0.32|0.14|||ANCOVA|||Change in lateral JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.|
1611922|NCT02528188|2960101|Superiority||LS Mean Ratio|0.69|Standard Error of the Mean|0.12||0.0281|2-Sided|95.0|0.5|0.96|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611923|NCT02528188|2960101|Superiority||LS Mean Ratio|0.75|Standard Error of the Mean|0.13||0.0854|2-Sided|95.0|0.54|1.04|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611924|NCT02528188|2960101|Superiority||LS Mean Ratio|0.88|Standard Error of the Mean|0.13||0.3595|2-Sided|95.0|0.66|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611925|NCT02528188|2960101|Superiority||LS Mean Ratio|0.87|Standard Error of the Mean|0.13||0.3348|2-Sided|95.0|0.66|1.15|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611926|NCT02528188|2960103|Superiority||LS Mean Ratio|1.06|Standard Error of the Mean|0.09||0.5148|2-Sided|95.0|0.89|1.26|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611927|NCT02528188|2960103|Superiority||LS Mean Ratio|0.99|Standard Error of the Mean|0.09||0.9119|2-Sided|95.0|0.83|1.18|||Negative binomial model|||Week 56: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611928|NCT02528188|2960103|Superiority||LS Mean Ratio|1.01|Standard Error of the Mean|0.09||0.8822|2-Sided|95.0|0.85|1.21|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611929|NCT02528188|2960103|Superiority||LS Mean Ratio|0.96|Standard Error of the Mean|0.09||0.6784|2-Sided|95.0|0.81|1.15|||Negative binomial model|||Week 48: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611930|NCT02528188|2960103|Superiority||LS Mean Ratio|0.97|Standard Error of the Mean|0.09||0.7469|2-Sided|95.0|0.81|1.16|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611931|NCT02528188|2960103|Superiority||LS Mean Ratio|0.97|Standard Error of the Mean|0.09||0.7426|2-Sided|95.0|0.81|1.16|||Negative binomial model|||Week 40: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611932|NCT02528188|2960103|Superiority||LS Mean Ratio|0.93|Standard Error of the Mean|0.08||0.441|2-Sided|95.0|0.78|1.11|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611933|NCT02528188|2960103|Superiority||LS Mean Ratio|0.94|Standard Error of the Mean|0.09||0.5041|2-Sided|95.0|0.79|1.12|||Negative binomial model|||Week 32: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611934|NCT02528188|2960103|Superiority||LS Mean Ratio|0.94|Standard Error of the Mean|0.09||0.5385|2-Sided|95.0|0.79|1.13|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611935|NCT02528188|2960103|Superiority||LS Mean Ratio|0.94|Standard Error of the Mean|0.09||0.5426|2-Sided|95.0|0.79|1.13|||Negative binomial model|||Week 24: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611936|NCT02528188|2960103|Superiority||LS Mean Ratio|0.9|Standard Error of the Mean|0.09||0.2817|2-Sided|95.0|0.74|1.09|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611937|NCT02528188|2960103|Superiority||LS Mean Ratio|0.93|Standard Error of the Mean|0.09||0.4485|2-Sided|95.0|0.77|1.13|||Negative binomial model|||Week 16: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611938|NCT02528188|2960103|Superiority||LS Mean Ratio|0.86|Standard Error of the Mean|0.07||0.0771|2-Sided|95.0|0.72|1.02|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611939|NCT02528188|2960103|Superiority||LS Mean Ratio|1.0|Standard Error of the Mean|0.09||0.9986|2-Sided|95.0|0.84|1.18|||Negative binomial model|||Week 8: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611940|NCT02528188|2960103|Superiority||LS Mean Ratio|0.91|Standard Error of the Mean|0.07||0.2279|2-Sided|95.0|0.78|1.06|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1612362|NCT02528188|2960145|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.1||0.6345|2-Sided|95.0|-0.24|0.15|||ANCOVA|||Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.|
1611941|NCT02528188|2960103|Superiority||LS Mean Ratio|0.97|Standard Error of the Mean|0.08||0.658|2-Sided|95.0|0.83|1.13|||Negative binomial model|||Week 4: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611942|NCT02528188|2960103|Superiority||LS Mean Ratio|1.01|Standard Error of the Mean|0.07||0.8441|2-Sided|95.0|0.89|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611943|NCT02528188|2960103|Superiority||LS Mean Ratio|1.02|Standard Error of the Mean|0.07||0.7746|2-Sided|95.0|0.89|1.16|||Negative binomial model|||Week 2: Analysis was performed using negative binomial model with model terms of baseline WOMAC Pain subscale score, baseline diary average pain score, index joint, Kellgren Lawrence grade, NSAID and treatment group.|
1611944|NCT02528188|2960105|Superiority||Odds Ratio (OR)|1.05||||0.5769|2-Sided|95.0|0.88|1.26|||Regression, Logistic|||Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611945|NCT02528188|2960105|Superiority||Odds Ratio (OR)|0.96||||0.6936|2-Sided|95.0|0.8|1.16|||Regression, Logistic|||Week 56: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611946|NCT02528188|2960105|Superiority||Odds Ratio (OR)|1.02||||0.8219|2-Sided|95.0|0.85|1.22|||Regression, Logistic|||Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611947|NCT02528188|2960105|Superiority||Odds Ratio (OR)|1.0||||0.9718|2-Sided|95.0|0.83|1.19|||Regression, Logistic|||Week 48: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611948|NCT02528188|2960105|Superiority||Odds Ratio (OR)|1.0||||0.9762|2-Sided|95.0|0.84|1.2|||Regression, Logistic|||Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611949|NCT02528188|2960105|Superiority||Odds Ratio (OR)|1.0||||0.9977|2-Sided|95.0|0.83|1.2|||Regression, Logistic|||Week 40: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611950|NCT02528188|2960105|Superiority||Odds Ratio (OR)|0.96||||0.6621|2-Sided|95.0|0.8|1.15|||Regression, Logistic|||Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611951|NCT02528188|2960105|Superiority||Odds Ratio (OR)|0.99||||0.9242|2-Sided|95.0|0.83|1.19|||Regression, Logistic|||Week 32: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611952|NCT02528188|2960105|Superiority||Odds Ratio (OR)|0.9||||0.2425|2-Sided|95.0|0.75|1.08|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611953|NCT02528188|2960105|Superiority||Odds Ratio (OR)|0.94||||0.4976|2-Sided|95.0|0.78|1.13|||Regression, Logistic|||Week 24: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611954|NCT02528188|2960105|Superiority||Odds Ratio (OR)|0.9||||0.2919|2-Sided|95.0|0.75|1.09|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611955|NCT02528188|2960105|Superiority||Odds Ratio (OR)|0.99||||0.9056|2-Sided|95.0|0.82|1.19|||Regression, Logistic|||Week 16: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611956|NCT02528188|2960105|Superiority||Odds Ratio (OR)|0.84||||0.0561|2-Sided|95.0|0.7|1.0|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611957|NCT02528188|2960105|Superiority||Odds Ratio (OR)|1.04||||0.6454|2-Sided|95.0|0.87|1.25|||Regression, Logistic|||Week 8: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611958|NCT02528188|2960105|Superiority||Odds Ratio (OR)|0.88||||0.143|2-Sided|95.0|0.73|1.05|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611959|NCT02528188|2960105|Superiority||Odds Ratio (OR)|1.03||||0.7691|2-Sided|95.0|0.86|1.22|||Regression, Logistic|||Week 4: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612523|NCT02522624|2960377|Superiority or Other|||||||0.57|||||||Regression, Linear|||Controlling for Numeracy.|
1611960|NCT02528188|2960105|Superiority||Odds Ratio (OR)|1.08||||0.391|2-Sided|95.0|0.9|1.29|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611961|NCT02528188|2960105|Superiority||Odds Ratio (OR)|1.15||||0.1136|2-Sided|95.0|0.97|1.38|||Regression, Logistic|||Week 2: Odds ratio and 95%CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611962|NCT02528188|2960106|Superiority|||||||0.0162|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.|
1611963|NCT02528188|2960106|Superiority|||||||0.0074|||||||Log Rank|||Missing data for the selected percentile(s) was due to the Kaplan-Meier estimate not reaching the level for discontinuation due to lack of efficacy.|
1611964|NCT02528188|2960107|Superiority||Odds Ratio (OR)|0.67||||0.0187|2-Sided|95.0|0.48|0.94|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611965|NCT02528188|2960107|Superiority||Odds Ratio (OR)|0.63||||0.0076|2-Sided|95.0|0.45|0.88|||Regression, Logistic|||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline diary average pain, baseline WOMAC pain score, classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611966|NCT02528188|2960108|Superiority|||||||0.1835|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611967|NCT02528188|2960108|Superiority|||||||0.0266|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611968|NCT02528188|2960108|Superiority|||||||0.0029|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611969|NCT02528188|2960108|Superiority|||||||0.0229|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611970|NCT02528188|2960109|Superiority|||||||0.1947|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611971|NCT02528188|2960109|Superiority|||||||0.0718|||||||Cochran-Mantel-Haenszel|||Week 56: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611972|NCT02528188|2960109|Superiority|||||||0.0049|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611973|NCT02528188|2960109|Superiority|||||||0.0823|||||||Cochran-Mantel-Haenszel|||Week 16: Cochran-Mantel-Haenszel test for row mean scores differ, stratified by the combinations of the three stratification factors (index joint, highest Kellgren-Lawrence grade and NSAID)|
1611974|NCT02528188|2960111|Superiority||LS Mean Difference|0.01|Standard Error of the Mean|1.32||0.996|2-Sided|95.0|-2.59|2.6|||ANCOVA|||TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611975|NCT02528188|2960111|Superiority||LS Mean Difference|1.94|Standard Error of the Mean|1.31||0.1373|2-Sided|95.0|-0.62|4.51|||ANCOVA|||TSQM Global Satisfaction; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611976|NCT02528188|2960111|Superiority||LS Mean Difference|3.55|Standard Error of the Mean|1.04||0.0007|2-Sided|95.0|1.51|5.6|||ANCOVA|||TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611977|NCT02528188|2960111|Superiority||LS Mean Difference|3.18|Standard Error of the Mean|1.05||0.0025|2-Sided|95.0|1.12|5.25|||ANCOVA|||TSQM Global Satisfaction; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611978|NCT02528188|2960111|Superiority||LS Mean Difference|1.48|Standard Error of the Mean|1.11||0.1838|2-Sided|95.0|-0.7|3.67|||ANCOVA|||TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611979|NCT02528188|2960111|Superiority||LS Mean Difference|1.85|Standard Error of the Mean|1.1||0.0937|2-Sided|95.0|-0.31|4.01|||ANCOVA|||TSQM Convenience; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611980|NCT02528188|2960111|Superiority||LS Mean Difference|2.07|Standard Error of the Mean|0.8||0.0098|2-Sided|95.0|0.5|3.65|||ANCOVA|||TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1612363|NCT02528188|2960145|Superiority||LS Mean Difference|0.01|Standard Error of the Mean|0.09||0.8885|2-Sided|95.0|-0.17|0.2|||ANCOVA|||Change in lateral JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.|
1611981|NCT02528188|2960111|Superiority||LS Mean Difference|1.8|Standard Error of the Mean|0.81||0.0264|2-Sided|95.0|0.21|3.38|||ANCOVA|||TSQM Convenience; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611982|NCT02528188|2960111|Superiority||LS Mean Difference|-9.34|Standard Error of the Mean|6.05||0.1349|2-Sided|95.0|-21.8|3.11|||ANCOVA|||TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611983|NCT02528188|2960111|Superiority||LS Mean Difference|7.27|Standard Error of the Mean|6.44||0.2694|2-Sided|95.0|-5.99|20.54|||ANCOVA|||TSQM Side Effects; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611984|NCT02528188|2960111|Superiority||LS Mean Difference|2.29|Standard Error of the Mean|3.71||0.5381|2-Sided|95.0|-5.04|9.62|||ANCOVA|||TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611985|NCT02528188|2960111|Superiority||LS Mean Difference|-2.42|Standard Error of the Mean|3.8||0.5253|2-Sided|95.0|-9.93|5.09|||ANCOVA|||TSQM Side Effects; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611986|NCT02528188|2960111|Superiority||LS Mean Difference|0.27|Standard Error of the Mean|1.46||0.8524|2-Sided|95.0|-2.6|3.14|||ANCOVA|||TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611987|NCT02528188|2960111|Superiority||LS Mean Difference|2.15|Standard Error of the Mean|1.45||0.1371|2-Sided|95.0|-0.69|4.99|||ANCOVA|||TSQM Effectiveness; Week 56: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611988|NCT02528188|2960111|Superiority||LS Mean Difference|4.67|Standard Error of the Mean|1.08|<|0.0001|2-Sided|95.0|2.56|6.78|||ANCOVA|||TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611989|NCT02528188|2960111|Superiority||LS Mean Difference|2.66|Standard Error of the Mean|1.08|<|0.0142|2-Sided|95.0|0.53|4.78|||ANCOVA|||TSQM Effectiveness; Week 16: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline diary average pain as covariates, and study site as a random effect.|
1611990|NCT02528188|2960119|Superiority||LS Mean Difference|3.26|Standard Error of the Mean|1.44||0.0238|2-Sided|95.0|0.43|6.08|||ANCOVA|||Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611991|NCT02528188|2960119|Superiority||LS Mean Difference|1.7|Standard Error of the Mean|1.44||0.2377|2-Sided|95.0|-1.12|4.52|||ANCOVA|||Week 56: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611992|NCT02528188|2960119|Superiority||LS Mean Difference|-0.77|Standard Error of the Mean|1.14||0.4991|2-Sided|95.0|-3.0|1.46|||ANCOVA|||Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611993|NCT02528188|2960119|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|1.14||0.917|2-Sided|95.0|-2.36|2.12|||ANCOVA|||Week 24: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611994|NCT02528188|2960119|Superiority||LS Mean Difference|-1.98|Standard Error of the Mean|1.04||0.057|2-Sided|95.0|-4.01|0.06|||ANCOVA|||Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611995|NCT02528188|2960119|Superiority||LS Mean Difference|-1.21|Standard Error of the Mean|1.05||0.247|2-Sided|95.0|-3.26|0.84|||ANCOVA|||Week 16: Percent Activity Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611996|NCT02528188|2960119|Superiority||LS Mean Difference|4.96|Standard Error of the Mean|2.58||0.0551|2-Sided|95.0|-0.11|10.04|||ANCOVA|||Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611997|NCT02528188|2960119|Superiority||LS Mean Difference|3.05|Standard Error of the Mean|2.62||0.2448|2-Sided|95.0|-2.1|8.2|||ANCOVA|||Week 56: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612128|NCT02528188|2960130|Superiority||Odds Ratio (OR)|1.37||||0.0116|2-Sided|95.0|1.07|1.75|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1611998|NCT02528188|2960119|Superiority||LS Mean Difference|-1.43|Standard Error of the Mean|2.05||0.486|2-Sided|95.0|-5.44|2.59|||ANCOVA|||Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1611999|NCT02528188|2960119|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|2.03||0.941|2-Sided|95.0|-4.13|3.83|||ANCOVA|||Week 24: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612000|NCT02528188|2960119|Superiority||LS Mean Difference|-0.48|Standard Error of the Mean|1.83||0.7945|2-Sided|95.0|-4.06|3.11|||ANCOVA|||Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612001|NCT02528188|2960119|Superiority||LS Mean Difference|-1.63|Standard Error of the Mean|1.82||0.3699|2-Sided|95.0|-5.21|1.94|||ANCOVA|||Week 16: Percent Overall Work Impairment: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612002|NCT02528188|2960119|Superiority||LS Mean Difference|4.68|Standard Error of the Mean|2.4||0.0527|2-Sided|95.0|-0.05|9.41|||ANCOVA|||Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612003|NCT02528188|2960119|Superiority||LS Mean Difference|3.1|Standard Error of the Mean|2.44||0.2049|2-Sided|95.0|-1.7|7.91|||ANCOVA|||Week 56: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612004|NCT02528188|2960119|Superiority||LS Mean Difference|-1.51|Standard Error of the Mean|1.96||0.4421|2-Sided|95.0|-5.36|2.34|||ANCOVA|||Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612005|NCT02528188|2960119|Superiority||LS Mean Difference|-0.19|Standard Error of the Mean|1.94||0.923|2-Sided|95.0|-4.0|3.63|||ANCOVA|||Week 24: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612006|NCT02528188|2960119|Superiority||LS Mean Difference|-0.34|Standard Error of the Mean|1.78||0.848|2-Sided|95.0|-3.84|3.15|||ANCOVA|||Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612007|NCT02528188|2960119|Superiority||LS Mean Difference|-1.48|Standard Error of the Mean|1.78||0.406|2-Sided|95.0|-4.96|2.01|||ANCOVA|||Week 16: Percent Impairment While Working: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612008|NCT02528188|2960119|Superiority||LS Mean Difference|2.64|Standard Error of the Mean|1.72||0.1261|2-Sided|95.0|-0.75|6.04|||ANCOVA|||Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612009|NCT02528188|2960119|Superiority||LS Mean Difference|0.68|Standard Error of the Mean|1.76||0.6974|2-Sided|95.0|-2.77|4.14|||ANCOVA|||Week 56: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612010|NCT02528188|2960119|Superiority||LS Mean Difference|0.53|Standard Error of the Mean|0.93||0.5678|2-Sided|95.0|-1.3|2.36|||ANCOVA|||Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612011|NCT02528188|2960119|Superiority||LS Mean Difference|0.03|Standard Error of the Mean|0.92||0.976|2-Sided|95.0|-1.78|1.83|||ANCOVA|||Week 24: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612012|NCT02528188|2960119|Superiority||LS Mean Difference|-0.43|Standard Error of the Mean|0.75||0.5656|2-Sided|95.0|-1.9|1.04|||ANCOVA|||Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612013|NCT02528188|2960119|Superiority||LS Mean Difference|0.58|Standard Error of the Mean|0.74||0.4303|2-Sided|95.0|-0.87|2.04|||ANCOVA|||Week 16: Percent Work Time Missed: ANCOVA model included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WPAI score and baseline diary average pain as covariates, and study site as a random effect.|
1612053|NCT02528188|2960125|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.14||0.4043|2-Sided|95.0|-0.38|0.15|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612014|NCT02528188|2960121|Superiority||LS Mean Difference|0.08|Standard Error of the Mean|0.15||0.5785|2-Sided|95.0|-0.21|0.38|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612015|NCT02528188|2960121|Superiority||LS Mean Difference|0.01|Standard Error of the Mean|0.15||0.9705|2-Sided|95.0|-0.28|0.29|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612016|NCT02528188|2960121|Superiority||LS Mean Difference|0.04|Standard Error of the Mean|0.15||0.8078|2-Sided|95.0|-0.25|0.33|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612017|NCT02528188|2960121|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.15||0.8081|2-Sided|95.0|-0.32|0.25|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612018|NCT02528188|2960121|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.14||0.7614|2-Sided|95.0|-0.33|0.24|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612019|NCT02528188|2960121|Superiority||LS Mean Difference|0.01|Standard Error of the Mean|0.14||0.9376|2-Sided|95.0|-0.27|0.29|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612020|NCT02528188|2960121|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.14||0.4439|2-Sided|95.0|-0.38|0.17|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612021|NCT02528188|2960121|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|0.14||0.8402|2-Sided|95.0|-0.3|0.25|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612022|NCT02528188|2960121|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.14||0.1439|2-Sided|95.0|-0.47|0.07|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612023|NCT02528188|2960121|Superiority||LS Mean Difference|-0.06|Standard Error of the Mean|0.14||0.6445|2-Sided|95.0|-0.33|0.2|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612024|NCT02528188|2960121|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|0.11||0.0053|2-Sided|95.0|-0.53|-0.09|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612025|NCT02528188|2960121|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.11||0.1543|2-Sided|95.0|-0.38|0.06|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612026|NCT02528188|2960121|Superiority||LS Mean Difference|-0.41|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.61|-0.21|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612348|NCT02528188|2960143|Superiority||Odds Ratio (OR)|0.71||||0.5996|2-Sided|95.0|0.2|2.54|||Regression, Logistic|||Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.|
1612027|NCT02528188|2960121|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.1|<|0.4402|2-Sided|95.0|-0.27|0.12|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612028|NCT02528188|2960121|Superiority||LS Mean Difference|-0.35|Standard Error of the Mean|0.1|<|0.0003|2-Sided|95.0|-0.54|-0.16|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612029|NCT02528188|2960121|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.1|<|0.0076|2-Sided|95.0|-0.45|-0.07|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612030|NCT02528188|2960121|Superiority||LS Mean Difference|0.0|Standard Error of the Mean|0.09|<|0.9749|2-Sided|95.0|-0.18|0.17|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612031|NCT02528188|2960121|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.09|<|0.0846|2-Sided|95.0|-0.33|0.02|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when going up or down stairs and baseline diary average pain as covariates, and study site as a random effect.|
1612032|NCT02528188|2960123|Superiority||LS Mean Difference|0.19|Standard Error of the Mean|0.15||0.1981|2-Sided|95.0|-0.1|0.47|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612033|NCT02528188|2960123|Superiority||LS Mean Difference|0.03|Standard Error of the Mean|0.14||0.8538|2-Sided|95.0|-0.26|0.31|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612034|NCT02528188|2960123|Superiority||LS Mean Difference|0.08|Standard Error of the Mean|0.14||0.5819|2-Sided|95.0|-0.19|0.35|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612035|NCT02528188|2960123|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|0.14||0.8317|2-Sided|95.0|-0.3|0.24|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612036|NCT02528188|2960123|Superiority||LS Mean Difference|0.06|Standard Error of the Mean|0.14||0.6485|2-Sided|95.0|-0.21|0.34|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612037|NCT02528188|2960123|Superiority||LS Mean Difference|0.0|Standard Error of the Mean|0.14||0.9981|2-Sided|95.0|-0.28|0.28|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612038|NCT02528188|2960123|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|0.14||0.8416|2-Sided|95.0|-0.3|0.24|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612039|NCT02528188|2960123|Superiority||LS Mean Difference|-0.02|Standard Error of the Mean|0.14||0.8806|2-Sided|95.0|-0.29|0.25|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612349|NCT02528188|2960143|Superiority||Odds Ratio (OR)|1.48||||0.4559|2-Sided|95.0|0.53|4.18|||Regression, Logistic|||Decrease in lateral JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.|
1612040|NCT02528188|2960123|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.13||0.2547|2-Sided|95.0|-0.41|0.11|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612041|NCT02528188|2960123|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.13||0.7646|2-Sided|95.0|-0.3|0.22|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612042|NCT02528188|2960123|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.11||0.0899|2-Sided|95.0|-0.4|0.03|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612043|NCT02528188|2960123|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.11||0.5372|2-Sided|95.0|-0.28|0.15|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612044|NCT02528188|2960123|Superiority||LS Mean Difference|-0.25|Standard Error of the Mean|0.1||0.012|2-Sided|95.0|-0.44|-0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612045|NCT02528188|2960123|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.1||0.7179|2-Sided|95.0|-0.23|0.16|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612046|NCT02528188|2960123|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.09||0.0106|2-Sided|95.0|-0.43|-0.06|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612047|NCT02528188|2960123|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.09||0.0137|2-Sided|95.0|-0.42|-0.05|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612048|NCT02528188|2960123|Superiority||LS Mean Difference|0.07|Standard Error of the Mean|0.09||0.3894|2-Sided|95.0|-0.09|0.24|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612049|NCT02528188|2960123|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.09||0.3622|2-Sided|95.0|-0.25|0.09|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain when walking on a flat surface and baseline diary average pain as covariates, and study site as a random effect.|
1612050|NCT02528188|2960125|Superiority||LS Mean Difference|0.02|Standard Error of the Mean|0.13||0.8688|2-Sided|95.0|-0.24|0.29|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612051|NCT02528188|2960125|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.14||0.7415|2-Sided|95.0|-0.31|0.22|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612052|NCT02528188|2960125|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.14||0.7663|2-Sided|95.0|-0.31|0.23|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612350|NCT02528188|2960143|Superiority||Odds Ratio (OR)|1.07||||0.8997|2-Sided|95.0|0.39|2.89|||Regression, Logistic|||Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.|
1612054|NCT02528188|2960125|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.13||0.4907|2-Sided|95.0|-0.35|0.17|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612055|NCT02528188|2960125|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.13||0.5582|2-Sided|95.0|-0.34|0.18|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612056|NCT02528188|2960125|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.13||0.2629|2-Sided|95.0|-0.41|0.11|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612057|NCT02528188|2960125|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.13||0.4074|2-Sided|95.0|-0.37|0.15|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612058|NCT02528188|2960125|Superiority||LS Mean Difference|-0.25|Standard Error of the Mean|0.13||0.053|2-Sided|95.0|-0.5|0.0|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612059|NCT02528188|2960125|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.13||0.4005|2-Sided|95.0|-0.36|0.14|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612060|NCT02528188|2960125|Superiority||LS Mean Difference|-0.34|Standard Error of the Mean|0.1||0.001|2-Sided|95.0|-0.54|-0.14|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612061|NCT02528188|2960125|Superiority||LS Mean Difference|-0.19|Standard Error of the Mean|0.1||0.0625|2-Sided|95.0|-0.39|0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612062|NCT02528188|2960125|Superiority||LS Mean Difference|-0.48|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.66|-0.3|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612063|NCT02528188|2960125|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.09|<|0.0251|2-Sided|95.0|-0.39|-0.03|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612064|NCT02528188|2960125|Superiority||LS Mean Difference|-0.39|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.56|-0.22|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612065|NCT02528188|2960125|Superiority||LS Mean Difference|-0.33|Standard Error of the Mean|0.09|<|0.0002|2-Sided|95.0|-0.5|-0.15|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612066|NCT02528188|2960125|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.08|<|0.3073|2-Sided|95.0|-0.24|0.08|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612067|NCT02528188|2960125|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.08|<|0.0119|2-Sided|95.0|-0.37|-0.05|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC average score and baseline diary average pain as covariates, and study site as a random effect.|
1612068|NCT02528188|2960127|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.14||0.7883|2-Sided|95.0|-0.32|0.24|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612069|NCT02528188|2960127|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|0.14||0.8129|2-Sided|95.0|-0.31|0.24|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612070|NCT02528188|2960127|Superiority||LS Mean Difference|-0.1|Standard Error of the Mean|0.14||0.4609|2-Sided|95.0|-0.37|0.17|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612071|NCT02528188|2960127|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.14||0.2442|2-Sided|95.0|-0.43|0.11|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612072|NCT02528188|2960127|Superiority||LS Mean Difference|-0.17|Standard Error of the Mean|0.14||0.2149|2-Sided|95.0|-0.45|0.1|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612073|NCT02528188|2960127|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.14||0.4002|2-Sided|95.0|-0.38|0.15|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612074|NCT02528188|2960127|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.14||0.1019|2-Sided|95.0|-0.49|0.04|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612075|NCT02528188|2960127|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.13||0.2328|2-Sided|95.0|-0.42|0.1|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612076|NCT02528188|2960127|Superiority||LS Mean Difference|-0.32|Standard Error of the Mean|0.13||0.0179|2-Sided|95.0|-0.58|-0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612077|NCT02528188|2960127|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.13||0.298|2-Sided|95.0|-0.4|0.12|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612078|NCT02528188|2960127|Superiority||LS Mean Difference|-0.44|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-0.65|-0.23|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612079|NCT02528188|2960127|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.11|<|0.0425|2-Sided|95.0|-0.43|-0.01|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612080|NCT02528188|2960127|Superiority||LS Mean Difference|-0.63|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.82|-0.43|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612109|NCT02528188|2960129|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.09|<|0.0005|2-Sided|95.0|-0.47|-0.13|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612081|NCT02528188|2960127|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.1|<|0.0031|2-Sided|95.0|-0.49|-0.1|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612082|NCT02528188|2960127|Superiority||LS Mean Difference|-0.48|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.67|-0.29|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612083|NCT02528188|2960127|Superiority||LS Mean Difference|-0.38|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.56|-0.19|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612084|NCT02528188|2960127|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.09|<|0.0134|2-Sided|95.0|-0.4|-0.05|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612085|NCT02528188|2960127|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|0.09|<|0.0004|2-Sided|95.0|-0.49|-0.14|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC stiffness subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612086|NCT02528188|2960129|Superiority||LS Mean Difference|0.02|Standard Error of the Mean|0.14||0.9072|2-Sided|95.0|-0.25|0.28|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612087|NCT02528188|2960129|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.13||0.3571|2-Sided|95.0|-0.39|0.14|||ANCOVA|||Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612088|NCT02528188|2960129|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.13||0.5719|2-Sided|95.0|-0.33|0.18|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612089|NCT02528188|2960129|Superiority||LS Mean Difference|-0.17|Standard Error of the Mean|0.13||0.1873|2-Sided|95.0|-0.43|0.08|||ANCOVA|||Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612090|NCT02528188|2960129|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.13||0.317|2-Sided|95.0|-0.39|0.13|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612091|NCT02528188|2960129|Superiority||LS Mean Difference|-0.17|Standard Error of the Mean|0.13||0.1837|2-Sided|95.0|-0.43|0.08|||ANCOVA|||Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612092|NCT02528188|2960129|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.13||0.1198|2-Sided|95.0|-0.45|0.05|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612093|NCT02528188|2960129|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.13||0.0944|2-Sided|95.0|-0.47|0.04|||ANCOVA|||Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612094|NCT02528188|2960129|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.12||0.018|2-Sided|95.0|-0.53|-0.05|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612412|NCT02527161|2960179|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in SF-12 Mental Component score from preoperative to 2 years.|
1612095|NCT02528188|2960129|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.12||0.0589|2-Sided|95.0|-0.48|0.01|||ANCOVA|||Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612096|NCT02528188|2960129|Superiority||LS Mean Difference|-0.33|Standard Error of the Mean|0.11||0.0025|2-Sided|95.0|-0.54|-0.12|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612097|NCT02528188|2960129|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.11||0.0064|2-Sided|95.0|-0.51|-0.08|||ANCOVA|||Week 20: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612098|NCT02528188|2960129|Superiority||LS Mean Difference|-0.34|Standard Error of the Mean|0.11||0.0011|2-Sided|95.0|-0.55|-0.14|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612099|NCT02528188|2960129|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.1||0.0238|2-Sided|95.0|-0.44|-0.03|||ANCOVA|||Week 16: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612100|NCT02528188|2960129|Superiority||LS Mean Difference|-0.45|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.64|-0.25|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612101|NCT02528188|2960129|Superiority||LS Mean Difference|-0.37|Standard Error of the Mean|0.1|<|0.0002|2-Sided|95.0|-0.57|-0.18|||ANCOVA|||Week 12: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612102|NCT02528188|2960129|Superiority||LS Mean Difference|-0.48|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.67|-0.28|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612103|NCT02528188|2960129|Superiority||LS Mean Difference|-0.36|Standard Error of the Mean|0.1|<|0.0002|2-Sided|95.0|-0.56|-0.17|||ANCOVA|||Week 10: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612104|NCT02528188|2960129|Superiority||LS Mean Difference|-0.45|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.63|-0.26|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612105|NCT02528188|2960129|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.09|<|0.0115|2-Sided|95.0|-0.42|-0.05|||ANCOVA|||Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612106|NCT02528188|2960129|Superiority||LS Mean Difference|-0.48|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.66|-0.3|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612107|NCT02528188|2960129|Superiority||LS Mean Difference|-0.37|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.55|-0.18|||ANCOVA|||Week 6: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612108|NCT02528188|2960129|Superiority||LS Mean Difference|-0.33|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.5|-0.16|||ANCOVA|||Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612127|NCT02528188|2960130|Superiority||Odds Ratio (OR)|0.95||||0.6279|2-Sided|95.0|0.76|1.18|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612110|NCT02528188|2960129|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.08|<|0.3336|2-Sided|95.0|-0.24|0.08|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612111|NCT02528188|2960129|Superiority||LS Mean Difference|-0.17|Standard Error of the Mean|0.08|<|0.032|2-Sided|95.0|-0.33|-0.01|||ANCOVA|||Week 3: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612112|NCT02528188|2960129|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.08|<|0.472|2-Sided|95.0|-0.2|0.09|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612113|NCT02528188|2960129|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.08|<|0.1589|2-Sided|95.0|-0.25|0.04|||ANCOVA|||Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612114|NCT02528188|2960129|Superiority||LS Mean Difference|0.0|Standard Error of the Mean|0.06|<|0.9686|2-Sided|95.0|-0.11|0.11|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612115|NCT02528188|2960129|Superiority||LS Mean Difference|0.09|Standard Error of the Mean|0.06|<|0.112|2-Sided|95.0|-0.02|0.2|||ANCOVA|||Week 1: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline pain in the index joint as covariate, and study site as a random effect.|
1612116|NCT02528188|2960130|Superiority||Odds Ratio (OR)|0.89||||0.322|2-Sided|95.0|0.7|1.12|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612117|NCT02528188|2960130|Superiority||Odds Ratio (OR)|0.93||||0.5284|2-Sided|95.0|0.74|1.17|||Regression, Logistic|||Week 56: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612118|NCT02528188|2960130|Superiority||Odds Ratio (OR)|1.0||||0.9981|2-Sided|95.0|0.79|1.26|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612119|NCT02528188|2960130|Superiority||Odds Ratio (OR)|0.96||||0.752|2-Sided|95.0|0.76|1.22|||Regression, Logistic|||Week 48: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612120|NCT02528188|2960130|Superiority||Odds Ratio (OR)|1.01||||0.9456|2-Sided|95.0|0.8|1.27|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612121|NCT02528188|2960130|Superiority||Odds Ratio (OR)|0.95||||0.6763|2-Sided|95.0|0.75|1.2|||Regression, Logistic|||Week 40: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612122|NCT02528188|2960130|Superiority||Odds Ratio (OR)|0.88||||0.2629|2-Sided|95.0|0.7|1.1|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612123|NCT02528188|2960130|Superiority||Odds Ratio (OR)|0.92||||0.4504|2-Sided|95.0|0.73|1.15|||Regression, Logistic|||Week 32: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612124|NCT02528188|2960130|Superiority||Odds Ratio (OR)|1.04||||0.7581|2-Sided|95.0|0.83|1.3|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612125|NCT02528188|2960130|Superiority||Odds Ratio (OR)|0.89||||0.3135|2-Sided|95.0|0.71|1.12|||Regression, Logistic|||Week 24: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612126|NCT02528188|2960130|Superiority||Odds Ratio (OR)|1.09||||0.4674|2-Sided|95.0|0.87|1.35|||Regression, Logistic|||Week 16: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612351|NCT02528188|2960143|Superiority||Odds Ratio (OR)|0.55||||0.3002|2-Sided|95.0|0.18|1.7|||Regression, Logistic|||Decrease in lateral JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.|
1612129|NCT02528188|2960130|Superiority||Odds Ratio (OR)|1.11||||0.4007|2-Sided|95.0|0.87|1.43|||Regression, Logistic|||Week 8: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612130|NCT02528188|2960130|Superiority||Odds Ratio (OR)|1.63||||0.0002|2-Sided|95.0|1.26|2.1|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612131|NCT02528188|2960130|Superiority||Odds Ratio (OR)|1.4||||0.0105|2-Sided|95.0|1.08|1.81|||Regression, Logistic|||Week 4: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612132|NCT02528188|2960130|Superiority||Odds Ratio (OR)|1.42||||0.0154|2-Sided|95.0|1.07|1.89|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612133|NCT02528188|2960130|Superiority||Odds Ratio (OR)|1.22||||0.1772|2-Sided|95.0|0.91|1.62|||Regression, Logistic|||Week 2: OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline PGA of OA scale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|
1612134|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.16||||0.3193|2-Sided|95.0|0.86|1.57|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: >=90% reduction|
1612135|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.02||||0.9044|2-Sided|95.0|0.75|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: >=90% reduction|
1612136|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.01||||0.9397|2-Sided|95.0|0.82|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: >=70% reduction|
1612137|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.03||||0.7732|2-Sided|95.0|0.84|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: >=70% reduction|
1612138|NCT02528188|2960132|Superiority||Odds Ratio (OR)|0.94||||0.5355|2-Sided|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: >=50% reduction|
1612139|NCT02528188|2960132|Superiority||Odds Ratio, log|1.06||||0.528|2-Sided|95.0|0.89|1.27|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: >=50% reduction|
1612140|NCT02528188|2960132|Superiority||Odds Ratio (OR)|0.92||||0.3857|2-Sided|95.0|0.77|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: >=30% reduction|
1612141|NCT02528188|2960132|Superiority||Odds Ratio (OR)|0.96||||0.6527|2-Sided|95.0|0.8|1.15|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 56: >=30% reduction|
1612142|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.29||||0.081|2-Sided|95.0|0.97|1.73|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: >=90% reduction|
1612143|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.08||||0.6342|2-Sided|95.0|0.8|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: >=90% reduction|
1612144|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.08||||0.4356|2-Sided|95.0|0.89|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: >=70% reduction|
1612145|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.14||||0.1843|2-Sided|95.0|0.94|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: >=70% reduction|
1612146|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.0||||0.9757|2-Sided|95.0|0.83|1.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: >=50% reduction|
1612352|NCT02528188|2960143|Superiority||Odds Ratio (OR)|2.65||||0.0016|2-Sided|95.0|1.45|4.85|||Regression, Logistic|||Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.|
1612147|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.07||||0.4488|2-Sided|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: >=50% reduction|
1612148|NCT02528188|2960132|Superiority||Odds Ratio (OR)|0.94||||0.5098|2-Sided|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: >=30% reduction|
1612149|NCT02528188|2960132|Superiority||Odds Ratio (OR)|0.99||||0.9095|2-Sided|95.0|0.83|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 48: >=30% reduction|
1612150|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.43||||0.0132|2-Sided|95.0|1.08|1.9|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: >=90% reduction|
1612151|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.08||||0.6273|2-Sided|95.0|0.8|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: >=90% reduction|
1612152|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.07||||0.525|2-Sided|95.0|0.88|1.3|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: >=70% reduction|
1612153|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.08||||0.4261|2-Sided|95.0|0.89|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: >=70% reduction|
1612154|NCT02528188|2960132|Superiority||Odds Ratio (OR)|0.99||||0.9385|2-Sided|95.0|0.83|1.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: >=50% reduction|
1612155|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.01||||0.898|2-Sided|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: >=50% reduction|
1612156|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.02||||0.8472|2-Sided|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: >=30% reduction|
1612157|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.02||||0.8443|2-Sided|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 40: >=30% reduction|
1612158|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.44||||0.0121|2-Sided|95.0|1.08|1.91|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: >=90% reduction|
1612159|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.18||||0.2762|2-Sided|95.0|0.88|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: >=90% reduction|
1612160|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.17||||0.1239|2-Sided|95.0|0.96|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: >=70% reduction|
1612161|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.14||||0.1985|2-Sided|95.0|0.93|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: >=70% reduction|
1612162|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.04||||0.695|2-Sided|95.0|0.87|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: >=50% reduction|
1612163|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.1||||0.2964|2-Sided|95.0|0.92|1.31|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: >=50% reduction|
1612164|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.02||||0.7979|2-Sided|95.0|0.86|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: >=30% reduction|
1612413|NCT02527161|2960180|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in SF-12 Mental Component score from preoperative to 12 months.|
1612165|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.03||||0.7607|2-Sided|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 32: >=30% reduction|
1612166|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.37||||0.0296|2-Sided|95.0|1.03|1.81|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: >=90% reduction|
1612167|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.13||||0.4074|2-Sided|95.0|0.85|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: >=90% reduction|
1612168|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.25||||0.0235|2-Sided|95.0|1.03|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: >=70% reduction|
1612169|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.12||||0.2472|2-Sided|95.0|0.92|1.36|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: >=70% reduction|
1612170|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.05||||0.5714|2-Sided|95.0|0.88|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: >=50% reduction|
1612171|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.12||||0.1944|2-Sided|95.0|0.94|1.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: >=50% reduction|
1612172|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.1||||0.2977|2-Sided|95.0|0.92|1.32|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: >=30% reduction|
1612173|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.02||||0.8393|2-Sided|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 24: >=30% reduction|
1612174|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.44||||0.0108|2-Sided|95.0|1.09|1.9|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: >=90% reduction|
1612175|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.11||||0.4658|2-Sided|95.0|0.83|1.49|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: >=90% reduction|
1612176|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.34||||0.0025|2-Sided|95.0|1.11|1.63|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: >=70% reduction|
1612177|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.1||||0.3571|2-Sided|95.0|0.9|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: >=70% reduction|
1612178|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.25||||0.0135|2-Sided|95.0|1.05|1.49|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: >=50% reduction|
1612179|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.12||||0.2097|2-Sided|95.0|0.94|1.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: >=50% reduction|
1612180|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.19||||0.0806|2-Sided|95.0|0.98|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: >=30% reduction|
1612181|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.18||||0.0977|2-Sided|95.0|0.97|1.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 16: >=30% reduction|
1612182|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.64||||0.0122|2-Sided|95.0|1.11|2.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: >=90% reduction|
1614330|NCT02494401|2963013|Superiority|||||||0.6||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)||||
1612183|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.31||||0.1942|2-Sided|95.0|0.87|1.96|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: >=90% reduction|
1612184|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.65|||<|0.0001|2-Sided|95.0|1.3|2.09|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: >=70% reduction|
1612185|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.39|||<|0.0077||95.0|1.09|1.77|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: >=70% reduction|
1612186|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.45|||<|0.0001|2-Sided|95.0|1.2|1.75|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: >=50% reduction|
1612187|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.25|||<|0.0196|2-Sided|95.0|1.04|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: >=50% reduction|
1612188|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.19|||<|0.0548|2-Sided|95.0|1.0|1.43|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: >=30% reduction|
1612189|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.03|||<|0.7613|2-Sided|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 8: >=30% reduction|
1612190|NCT02528188|2960132|Superiority||Odds Ratio (OR)|2.12|||<|0.0021|2-Sided|95.0|1.31|3.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: >=90% reduction|
1612191|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.76|||<|0.0235|2-Sided|95.0|1.08|2.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: >=90% reduction|
1612192|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.49|||<|0.0031|2-Sided|95.0|1.14|1.93|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: >=70% reduction|
1612193|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.45|||<|0.006|2-Sided|95.0|1.11|1.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: >=70% reduction|
1612194|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.51|||<|0.0001|2-Sided|95.0|1.24|1.85|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: >=50% reduction|
1612195|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.5|||<|0.0001|2-Sided|95.0|1.22|1.83|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: >=50% reduction|
1612196|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.27|||<|0.008|2-Sided|95.0|1.07|1.52|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: >=30% reduction|
1612197|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.26|||<|0.0108|2-Sided|95.0|1.05|1.51|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 4: >=30% reduction|
1612198|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.9|||<|0.0349|2-Sided|95.0|1.05|3.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: >=90% reduction|
1612199|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.22|||<|0.5442|2-Sided|95.0|0.64|2.34|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: >=90% reduction|
1612200|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.44|||<|0.0425|2-Sided|95.0|1.01|2.04|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: >=70% reduction|
1614331|NCT02494401|2963013|Superiority|||||||0.69||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)||||
1612201|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.44|||<|0.0434|2-Sided|95.0|1.01|2.04|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: >=70% reduction|
1612202|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.12|||<|0.3728|2-Sided|95.0|0.88|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: >=50% reduction|
1612203|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.36|||<|0.01|2-Sided|95.0|1.08|1.72|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: >=50% reduction|
1612204|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.01|||<|0.9032|2-Sided|95.0|0.84|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: >=30% reduction|
1612205|NCT02528188|2960132|Superiority||Odds Ratio (OR)|1.19|||<|0.0651|2-Sided|95.0|0.99|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model.Logistic regression model included baseline WOMAC physical function subscale,baseline diary average pain,classification variables index joint,highest Kellgren-Lawrence grade,NSAID and treatment.|Week 2: >=30% reduction|
1612206|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.03||||0.8495|2-Sided|95.0|0.77|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: >=90% reduction|
1612207|NCT02528188|2960134|Superiority||Odds Ratio (OR)|0.99||||0.9384|2-Sided|95.0|0.74|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: >=90% reduction|
1612208|NCT02528188|2960134|Superiority||Odds Ratio (OR)|0.97||||0.7686|2-Sided|95.0|0.8|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: >=70% reduction|
1612209|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.03||||0.7624|2-Sided|95.0|0.85|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: >=70% reduction|
1612210|NCT02528188|2960134|Superiority||Odds Ratio (OR)|0.92||||0.3467|2-Sided|95.0|0.77|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: >=50% reduction|
1612211|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.03||||0.7429|2-Sided|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: >=50% reduction|
1612212|NCT02528188|2960134|Superiority||Odds Ratio (OR)|0.93||||0.4491|2-Sided|95.0|0.78|1.11|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: >=30% reduction|
1612213|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.01||||0.9046|2-Sided|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56: >=30% reduction|
1612214|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.07||||0.6405|2-Sided|95.0|0.81|1.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: >=90% reduction|
1612215|NCT02528188|2960134|Superiority||Odds Ratio (OR)|0.96||||0.7729|2-Sided|95.0|0.72|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: >=90% reduction|
1612216|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.04||||0.706|2-Sided|95.0|0.85|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: >=70% reduction|
1612217|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.05||||0.6436|2-Sided|95.0|0.86|1.27|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: >=70% reduction|
1612218|NCT02528188|2960134|Superiority||Odds Ratio (OR)|0.95||||0.5638|2-Sided|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: >=50% reduction|
1612353|NCT02528188|2960143|Superiority||Odds Ratio (OR)|2.01||||0.0301|2-Sided|95.0|1.07|3.77|||Regression, Logistic|||Decrease in medial JSW at Week 80: Logistic regression model included treatment, and baseline JSW as covariate.|
1612219|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.07||||0.4382|2-Sided|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: >=50% reduction|
1612220|NCT02528188|2960134|Superiority||Odds Ratio (OR)|0.94||||0.5032|2-Sided|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: >=30% reduction|
1612221|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.01||||0.9093|2-Sided|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48: >=30% reduction|
1612222|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.16||||0.2951|2-Sided|95.0|0.88|1.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: >=90% reduction|
1612223|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.04||||0.8069|2-Sided|95.0|0.78|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: >=90% reduction|
1612224|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.04||||0.6786|2-Sided|95.0|0.86|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: >=70% reduction|
1612225|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.03||||0.799|2-Sided|95.0|0.85|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: >=70% reduction|
1612226|NCT02528188|2960134|Superiority||Odds Ratio (OR)|0.96||||0.6817|2-Sided|95.0|0.81|1.15|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: >=50% reduction|
1612227|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.04||||0.6262|2-Sided|95.0|0.88|1.25|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: >=50% reduction|
1612228|NCT02528188|2960134|Superiority||Odds Ratio (OR)|0.98||||0.8632|2-Sided|95.0|0.82|1.18|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: >=30% reduction|
1612229|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.03||||0.7331|2-Sided|95.0|0.86|1.23|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40: >=30% reduction|
1612230|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.32||||0.0548|2-Sided|95.0|0.99|1.74|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: >=90% reduction|
1612231|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.02||||0.901|2-Sided|95.0|0.76|1.37|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: >=90% reduction|
1612232|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.21||||0.0578|2-Sided|95.0|0.99|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: >=70% reduction|
1612233|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.19||||0.0757|2-Sided|95.0|0.98|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: >=70% reduction|
1612234|NCT02528188|2960134|Superiority||Odds Ratio (OR)|0.98||||0.7973|2-Sided|95.0|0.82|1.17|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: >=50% reduction|
1612235|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.04||||0.6493|2-Sided|95.0|0.87|1.24|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: >=50% reduction|
1612236|NCT02528188|2960134|Superiority||Odds Ratio (OR)|0.97||||0.7317|2-Sided|95.0|0.81|1.16|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: >=30% reduction|
1612354|NCT02528188|2960143|Superiority||Odds Ratio (OR)|2.37||||0.0021|2-Sided|95.0|1.37|4.12|||Regression, Logistic|||Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.|
1612237|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.02||||0.8682|2-Sided|95.0|0.85|1.21|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32: >=30% reduction|
1612238|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.17||||0.2497|2-Sided|95.0|0.89|1.53|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: >=90% reduction|
1612239|NCT02528188|2960134|Superiority||Odds Ratio (OR)|0.88||||0.3641|2-Sided|95.0|0.66|1.16|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: >=90% reduction|
1612240|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.24||||0.0248|2-Sided|95.0|1.03|1.5|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: >=70% reduction|
1612241|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.08||||0.4071|2-Sided|95.0|0.89|1.31|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: >=70% reduction|
1612242|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.08||||0.4078|2-Sided|95.0|0.9|1.29|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: >=50% reduction|
1612243|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.07||||0.4406|2-Sided|95.0|0.9|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: >=50% reduction|
1612244|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.07||||0.4374|2-Sided|95.0|0.9|1.29|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: >=30% reduction|
1612245|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.0||||0.9932|2-Sided|95.0|0.83|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24: >=30% reduction|
1612246|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.57||||0.0024|2-Sided|95.0|1.17|2.11|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: >=90% reduction|
1612247|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.24||||0.159|2-Sided|95.0|0.92|1.69|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: >=90% reduction|
1612248|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.33||||0.0033|2-Sided|95.0|1.1|1.61|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: >=70% reduction|
1612249|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.0||||0.9805|2-Sided|95.0|0.83|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: >=70% reduction|
1612250|NCT02528188|2960134|Superiority|The two key secondary comparisons for 'Participants with >=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus NSAID and tanezumab 5 mg treatment group versus NSAID) could not be considered significant since preceding tests in the graphical testing procedure were not significant.|Odds Ratio (OR)|1.22||||0.0262|2-Sided|95.0|1.02|1.46|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: >=50% reduction|
1612251|NCT02528188|2960134|Superiority|The two key secondary comparisons for 'Participants with >=50% reduction from baseline in WOMAC Pain at Week 16' (tanezumab 2.5 mg treatment group versus NSAID and tanezumab 5 mg treatment group versus NSAID) could not be considered significant since preceding tests in the graphical testing procedure were not significant.|Odds Ratio (OR)|1.15||||0.1322|2-Sided|95.0|0.96|1.37|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: >=50% reduction|
1612252|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.21||||0.0529|2-Sided|95.0|1.0|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: >=30% reduction|
1612253|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.15||||0.1635|2-Sided|95.0|0.95|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16: >=30% reduction|
1615065|NCT02473471|2964572|Other|||||||0.809|||||||t-test, 2 sided|||Day 7 after intervention|
1612254|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.6||||0.0207|2-Sided|95.0|1.07|2.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: >=90% reduction|
1612255|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.11||||0.6421|2-Sided|95.0|0.72|1.7|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: >=90% reduction|
1612256|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.53||||0.0003|2-Sided|95.0|1.22|1.92|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: >=70% reduction|
1612257|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.26||||0.0535|2-Sided|95.0|1.0|1.59|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: >=70% reduction|
1612258|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.34||||0.0021|2-Sided|95.0|1.11|1.61|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: >=50% reduction|
1612259|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.2||||0.0559|2-Sided|95.0|1.0|1.44|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: >=50% reduction|
1612260|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.21||||0.0336|2-Sided|95.0|1.02|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: >=30% reduction|
1612261|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.07||||0.4744|2-Sided|95.0|0.89|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8: >=30% reduction|
1612262|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.59||||0.048|2-Sided|95.0|1.0|2.52|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: >=90% reduction|
1612263|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.36||||0.1971|2-Sided|95.0|0.85|2.19|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: >=90% reduction|
1612264|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.45||||0.0046|2-Sided|95.0|1.12|1.88|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: >=70% reduction|
1612265|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.24||||0.1037|2-Sided|95.0|0.96|1.62|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: >=70% reduction|
1612266|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.32||||0.0068|2-Sided|95.0|1.08|1.6|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: >=50% reduction|
1612267|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.31||||0.0079|2-Sided|95.0|1.07|1.6|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: >=50% reduction|
1612268|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.23||||0.0239|2-Sided|95.0|1.03|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: >=30% reduction|
1612269|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.26||||0.0114|2-Sided|95.0|1.05|1.5|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4: >=30% reduction|
1612270|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.38||||0.3089|2-Sided|95.0|0.74|2.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: >=90% reduction|
1612271|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.3||||0.4006|2-Sided|95.0|0.7|2.42|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: >=90% reduction|
1612355|NCT02528188|2960143|Superiority||Odds Ratio (OR)|1.85||||0.0358|2-Sided|95.0|1.04|3.29|||Regression, Logistic|||Decrease in medial JSW at Week 56: Logistic regression model included treatment, and baseline JSW as covariate.|
1612272|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.14||||0.478|2-Sided|95.0|0.8|1.62|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: >=70% reduction|
1612273|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.23||||0.255|2-Sided|95.0|0.86|1.74|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: >=70% reduction|
1612274|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.14||||0.3|2-Sided|95.0|0.89|1.45|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: >=50% reduction|
1612275|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.24||||0.0748|2-Sided|95.0|0.98|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: >=50% reduction|
1612276|NCT02528188|2960134|Superiority||Odds Ratio (OR)|0.91||||0.3146|2-Sided|95.0|0.75|1.1|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: >=30% reduction|
1612277|NCT02528188|2960134|Superiority||Odds Ratio (OR)|1.11||||0.2938|2-Sided|95.0|0.92|1.33|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2: >=30% reduction|
1612278|NCT02528188|2960135|Superiority||Odds Ratio (OR)|0.94||||0.4823|2-Sided|95.0|0.79|1.12|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56|
1612279|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.02||||0.8302|2-Sided|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 56|
1612280|NCT02528188|2960135|Superiority||Odds Ratio (OR)|0.95||||0.587|2-Sided|95.0|0.8|1.14|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48|
1612281|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.0||||0.9901|2-Sided|95.0|0.84|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 48|
1612282|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.02||||0.8553|2-Sided|95.0|0.85|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40|
1612283|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.01||||0.9557|2-Sided|95.0|0.84|1.2|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 40|
1612284|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.05||||0.5697|2-Sided|95.0|0.88|1.26|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32|
1612285|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.02||||0.8018|2-Sided|95.0|0.86|1.22|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 32|
1612286|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.16||||0.1154|2-Sided|95.0|0.96|1.39|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24|
1612287|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.05||||0.6258|2-Sided|95.0|0.87|1.25|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 24|
1612288|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.19||||0.1004|2-Sided|95.0|0.97|1.47|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16|
1612289|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.18||||0.1117|2-Sided|95.0|0.96|1.46|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 16|
1612290|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.3||||0.006||95.0|1.08|1.58|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8|
1615066|NCT02473471|2964572|Other|||||||0.743|||||||t-test, 2 sided|||Day 5 after intervention|
1612291|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.14||||0.1584|2-Sided|95.0|0.95|1.38|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 8|
1612292|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.29||||0.0057|2-Sided|95.0|1.08|1.55|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4|
1612293|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.29||||0.0059|2-Sided|95.0|1.08|1.54|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 4|
1612294|NCT02528188|2960135|Superiority||Odds Ratio (OR)|0.95||||0.5451|2-Sided|95.0|0.79|1.13|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2|
1612295|NCT02528188|2960135|Superiority||Odds Ratio (OR)|1.07||||0.4691|2-Sided|95.0|0.89|1.28|||Regression, Logistic||OR and 95% CI estimated from logistic regression model. Logistic regression model included baseline WOMAC pain subscale, baseline diary average pain, and classification variables index joint, highest Kellgren-Lawrence grade, NSAID and treatment.|Week 2|
1612296|NCT02528188|2960137|Superiority||LS Mean Difference|0.06|Standard Error of the Mean|0.05||0.2814|2-Sided|95.0|-0.05|0.16|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612297|NCT02528188|2960137|Superiority||LS Mean Difference|0.01|Standard Error of the Mean|0.05||0.8856|2-Sided|95.0|-0.09|0.11|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612298|NCT02528188|2960137|Superiority||LS Mean Difference|0.02|Standard Error of the Mean|0.05||0.728|2-Sided|95.0|-0.09|0.12|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612299|NCT02528188|2960137|Superiority||LS Mean Difference|-0.02|Standard Error of the Mean|0.05||0.6648|2-Sided|95.0|-0.13|0.08|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612300|NCT02528188|2960137|Superiority||LS Mean Difference|0.0|Standard Error of the Mean|0.05||0.9995|2-Sided|95.0|-0.1|0.1|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612301|NCT02528188|2960137|Superiority||LS Mean Difference|-0.01|Standard Error of the Mean|0.05||0.8784|2-Sided|95.0|-0.11|0.09|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612302|NCT02528188|2960137|Superiority||LS Mean Difference|0.01|Standard Error of the Mean|0.05||0.9137|2-Sided|95.0|-0.09|0.11|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612303|NCT02528188|2960137|Superiority||LS Mean Difference|0.0|Standard Error of the Mean|0.05||0.983|2-Sided|95.0|-0.1|0.1|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612304|NCT02528188|2960137|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.05||0.3292|2-Sided|95.0|-0.14|0.05|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612305|NCT02528188|2960137|Superiority||LS Mean Difference|0.0|Standard Error of the Mean|0.05||0.9718|2-Sided|95.0|-0.1|0.1|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612356|NCT02528188|2960144|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.1||0.5005|2-Sided|95.0|-0.26|0.13|||ANCOVA|||Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.|
1612306|NCT02528188|2960137|Superiority||LS Mean Difference|-0.09|Standard Error of the Mean|0.03||0.0061|2-Sided|95.0|-0.16|-0.03|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612307|NCT02528188|2960137|Superiority||LS Mean Difference|-0.01|Standard Error of the Mean|0.03||0.7799|2-Sided|95.0|-0.08|0.06|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612308|NCT02528188|2960137|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.03|<|0.0001|2-Sided|95.0|-0.21|-0.08|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612309|NCT02528188|2960137|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.03|<|0.0002|2-Sided|95.0|-0.19|-0.06|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612310|NCT02528188|2960137|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.03|<|0.2049|2-Sided|95.0|-0.1|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612311|NCT02528188|2960137|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.03|<|0.2159|2-Sided|95.0|-0.1|0.02|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612312|NCT02528188|2960139|Superiority||LS Mean Difference|0.05|Standard Error of the Mean|0.14||0.733|2-Sided|95.0|-0.22|0.32|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612313|NCT02528188|2960139|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.14||0.7305|2-Sided|95.0|-0.32|0.22|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612314|NCT02528188|2960139|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.14||0.7747|2-Sided|95.0|-0.31|0.23|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612315|NCT02528188|2960139|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.14||0.4394|2-Sided|95.0|-0.38|0.16|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612316|NCT02528188|2960139|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.14||0.5756|2-Sided|95.0|-0.35|0.19|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612317|NCT02528188|2960139|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.14||0.6344|2-Sided|95.0|-0.34|0.2|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612318|NCT02528188|2960139|Superiority||LS Mean Difference|-0.13|Standard Error of the Mean|0.13||0.3404|2-Sided|95.0|-0.39|0.13|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612357|NCT02528188|2960144|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.1||0.0645|2-Sided|95.0|-0.37|0.01|||ANCOVA|||Change at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.|
1614332|NCT02494401|2963013|Superiority|||||||0.96||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)||||
1612319|NCT02528188|2960139|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.13||0.4072|2-Sided|95.0|-0.38|0.15|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612320|NCT02528188|2960139|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.13||0.0832|2-Sided|95.0|-0.47|0.03|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612321|NCT02528188|2960139|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.13||0.3621|2-Sided|95.0|-0.37|0.13|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612322|NCT02528188|2960139|Superiority||LS Mean Difference|-0.42|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.61|-0.23|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612323|NCT02528188|2960139|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.09|<|0.0517|2-Sided|95.0|-0.37|0.0|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612324|NCT02528188|2960139|Superiority||LS Mean Difference|-0.35|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.53|-0.17|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612325|NCT02528188|2960139|Superiority||LS Mean Difference|-0.32|Standard Error of the Mean|0.09|<|0.0004|2-Sided|95.0|-0.5|-0.15|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612326|NCT02528188|2960139|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.08|<|0.3286|2-Sided|95.0|-0.25|0.08|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612327|NCT02528188|2960139|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.08|<|0.015|2-Sided|95.0|-0.37|-0.04|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint and highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612328|NCT02528188|2960141|Superiority||LS Mean Difference|0.05|Standard Error of the Mean|0.14||0.7076|2-Sided|95.0|-0.22|0.32|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612329|NCT02528188|2960141|Superiority||LS Mean Difference|-0.02|Standard Error of the Mean|0.14||0.8782|2-Sided|95.0|-0.29|0.25|||ANCOVA|||Change at Week 56: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612330|NCT02528188|2960141|Superiority||LS Mean Difference|-0.01|Standard Error of the Mean|0.14||0.9345|2-Sided|95.0|-0.28|0.26|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612331|NCT02528188|2960141|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.13||0.5888|2-Sided|95.0|-0.33|0.19|||ANCOVA|||Change at Week 48: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612358|NCT02528188|2960144|Superiority||LS Mean Difference|-0.19|Standard Error of the Mean|0.08||0.023|2-Sided|95.0|-0.35|-0.03|||ANCOVA|||Change at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.|
1612332|NCT02528188|2960141|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.13||0.7328|2-Sided|95.0|-0.31|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612333|NCT02528188|2960141|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.14||0.7526|2-Sided|95.0|-0.31|0.22|||ANCOVA|||Change at Week 40: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612334|NCT02528188|2960141|Superiority||LS Mean Difference|-0.11|Standard Error of the Mean|0.13||0.4224|2-Sided|95.0|-0.37|0.16|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612335|NCT02528188|2960141|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.13||0.6237|2-Sided|95.0|-0.33|0.2|||ANCOVA|||Change at Week 32: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612336|NCT02528188|2960141|Superiority||LS Mean Difference|-0.19|Standard Error of the Mean|0.13||0.1339|2-Sided|95.0|-0.44|0.06|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612337|NCT02528188|2960141|Superiority||LS Mean Difference|-0.06|Standard Error of the Mean|0.13||0.6349|2-Sided|95.0|-0.31|0.19|||ANCOVA|||Change at Week 24: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612338|NCT02528188|2960141|Superiority||LS Mean Difference|-0.38|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.57|-0.2|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612339|NCT02528188|2960141|Superiority||LS Mean Difference|-0.14|Standard Error of the Mean|0.09|<|0.1273|2-Sided|95.0|-0.33|0.04|||ANCOVA|||Change at Week 8: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612340|NCT02528188|2960141|Superiority||LS Mean Difference|-0.32|Standard Error of the Mean|0.09|<|0.0005|2-Sided|95.0|-0.5|-0.14|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612341|NCT02528188|2960141|Superiority||LS Mean Difference|-0.27|Standard Error of the Mean|0.09|<|0.0029|2-Sided|95.0|-0.45|-0.09|||ANCOVA|||Change at Week 4: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612342|NCT02528188|2960141|Superiority||LS Mean Difference|0.06|Standard Error of the Mean|0.08|<|0.4557|2-Sided|95.0|-0.1|0.23|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612343|NCT02528188|2960141|Superiority||LS Mean Difference|-0.1|Standard Error of the Mean|0.08|<|0.2212|2-Sided|95.0|-0.27|0.06|||ANCOVA|||Change at Week 2: Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612344|NCT02528188|2960142|Superiority||Odds Ratio (OR)|3.11||||0.0976|2-Sided|95.0|0.81|11.9|||Regression, Logistic|||Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariate|
1612345|NCT02528188|2960142|Superiority||Odds Ratio (OR)|3.12||||0.0967|2-Sided|95.0|0.81|11.95|||Regression, Logistic|||Decrease at Week 80: Logistic regression model included treatment, and baseline JSW as covariate|
1612346|NCT02528188|2960142|Superiority||Odds Ratio (OR)|3.42||||0.0681|2-Sided|95.0|0.91|12.84|||Regression, Logistic|||Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariate|
1612347|NCT02528188|2960142|Superiority||Odds Ratio (OR)|3.37||||0.0714|2-Sided|95.0|0.9|12.65|||Regression, Logistic|||Decrease at Week 56: Logistic regression model included treatment, and baseline JSW as covariate|
1612364|NCT02528188|2960145|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.05||0.0128|2-Sided|95.0|-0.22|-0.03|||ANCOVA|||Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.|
1612365|NCT02528188|2960145|Superiority||LS Mean Difference|-0.08|Standard Error of the Mean|0.05||0.1162|2-Sided|95.0|-0.17|0.02|||ANCOVA|||Change in medial JSW at Week 80: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.|
1612366|NCT02528188|2960145|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.04|<|0.0001|2-Sided|95.0|-0.24|-0.08|||ANCOVA|||Change in medial JSW at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.|
1612367|NCT02528188|2960145|Superiority||LS Mean Difference|-0.07|Standard Error of the Mean|0.04|<|0.0979|2-Sided|95.0|-0.15|0.01|||ANCOVA|||Change in medial JSW width at Week 56: ANCOVA model included treatment, baseline JSW as covariate, and study site as a random effect.|
1612368|NCT02528188|2960146|Superiority||Rate Difference|95.83|||<|0.0001|2-Sided|95.0|70.25|121.42|||Poisson model for rate difference||||
1612369|NCT02528188|2960146|Superiority||Rate Difference|48.25|||<|0.0001|2-Sided|95.0|26.76|69.74||The event of adjudicated primary osteonecrosis in the tanezumab 2.5 mg treatment group is not included in this analysis. Conclusions for this analysis do not change as the comparison to NSAID is already statistically significant in favor of NSAID.|Poisson model for rate difference||||
1612370|NCT02528188|2960147|Superiority||Risk Difference (RD)|9.41|||<|0.0001|2-Sided|95.0|6.73|12.52|||Exact methods for risk difference||||
1612371|NCT02528188|2960147|Superiority||Risk Difference (RD)|4.87|||<|0.0002|2-Sided|95.0|2.43|7.74||The event of adjudicated primary osteonecrosis in the tanezumab 2.5 mg treatment group is not included in this analysis. Conclusions for this analysis do not change as the comparison to NSAID is already statistically significant in favor of NSAID.|Exact methods for risk difference||||
1612372|NCT02528188|2960148|Superiority||Rate Difference|1.0|||||||||||||95% CI was not estimable since there were less number of participants with events.|Primary osteonecrosis|
1612373|NCT02528188|2960148|Superiority||Poisson model for rate difference|1.0|||||||||||||95% CI was not estimable since there were less number of participants with events.|Primary osteonecrosis|
1612374|NCT02528188|2960148|Superiority||Rate Difference|2.98||||0.3636|2-Sided|95.0|-3.44|9.39|||Poisson model for rate difference|||Subchondral Insufficiency Fracture|
1612375|NCT02528188|2960148|Superiority||Rate Difference|1.9||||0.5394|2-Sided|95.0|-4.17|7.96|||Poisson model for rate difference|||Subchondral Insufficiency Fracture|
1612376|NCT02528188|2960148|Superiority||Rate Difference|12.88||||0.0008|2-Sided|95.0|5.36|20.39|||Poisson model for rate difference|||Rapidly Progressive OA Type 2|
1612377|NCT02528188|2960148|Superiority||Rate Difference|1.94||||0.3214|2-Sided|95.0|-1.89|5.76|||Poisson model for rate difference|||Rapidly Progressive OA Type 2|
1612378|NCT02528188|2960148|Superiority||Rate Difference|38.22|||<|0.0001|2-Sided|95.0|23.05|53.4|||Poisson model for rate difference|||Rapidly Progressive OA Type 1|
1612379|NCT02528188|2960148|Superiority||Rate Difference|17.58|||<|0.0047|2-Sided|95.0|5.39|29.76|||Poisson model for rate difference|||Rapidly Progressive OA Type 1|
1612380|NCT02528188|2960148|Superiority||Rate Difference|51.48|||<|0.0001|2-Sided|95.0|34.47|68.5|||Poisson model for rate difference|||Rapidly Progressive OA Type 1 or 2|
1612381|NCT02528188|2960148|Superiority||Rate Difference|19.56|||<|0.0027|2-Sided|95.0|6.78|32.35|||Poisson model for rate difference|||Rapidly Progressive OA Type 1 or 2|
1612382|NCT02528188|2960149|Superiority||Risk difference|0.3||||0.5632|2-Sided|95.0|-0.86|2.03|||Exact methods for risk difference|||Subchondral insufficiency fracture|
1612383|NCT02528188|2960149|Superiority||Risk difference|0.2||||0.6824|2-Sided|95.0|-0.96|1.9|||Exact methods for risk difference|||Subchondral insufficiency fracture|
1612384|NCT02528188|2960149|Superiority||Risk difference|0.1||||0.7182|2-Sided|95.0|-0.74|1.52|||Exact methods for risk difference|||Primary osteonecrosis|
1612385|NCT02528188|2960149|Superiority||Risk difference|0.1||||0.7245|2-Sided|95.0|-0.74|1.51|||Exact methods for risk difference|||Primary osteonecrosis|
1612386|NCT02528188|2960149|Superiority||Risk difference|1.3||||0.0388|2-Sided|95.0|0.17|2.97|||Exact methods for risk difference|||Rapidly Progressive OA Type 2|
1612387|NCT02528188|2960149|Superiority||Risk difference|0.2||||0.6168|2-Sided|95.0|-0.76|1.71|||Exact methods for risk difference|||Rapidly Progressive OA Type 2|
1612388|NCT02528188|2960149|Superiority||Risk difference|3.81||||0.0001|2-Sided|95.0|1.99|6.12|||Exact methods for risk difference|||Rapidly Progressive OA Type 1|
1612389|NCT02528188|2960149|Superiority||Risk difference|1.79||||0.0366|2-Sided|95.0|0.16|3.92|||Exact methods for risk difference|||Rapidly Progressive OA Type 1|
1612390|NCT02528188|2960149|Superiority||Risk difference|5.11|||<|0.0001|2-Sided|95.0|3.16|7.54|||Exact methods for risk difference|||Rapidly Progressive OA Type 1 or 2|
1612391|NCT02528188|2960149|Superiority||Risk Difference|1.99|||<|0.0248|2-Sided|95.0|0.31|4.17|||Exact methods for risk difference|||Rapidly progressive OA Type 1 or 2|
1612392|NCT02528188|2960150|Superiority||Rate Difference|16.9||||0.001|2-Sided|95.0|6.8|27.0|||Poisson model for rate difference||||
1612393|NCT02528188|2960150|Superiority||Rate Difference|4.8||||0.2035|2-Sided|95.0|-2.6|12.2|||Poisson model for rate difference||||
1612394|NCT02528188|2960151|Superiority||Risk Difference (RD)|1.7||||0.0238|2-Sided|95.0|0.31|3.63|||Exact methods for risk difference||||
1612395|NCT02528188|2960151|Superiority||Risk Difference (RD)|0.5||||0.4082|2-Sided|95.0|-0.75|2.28|||Exact methods for risk difference||||
1612414|NCT02527161|2960180|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in SF-12 Physical Component score from preoperative to 12 months.|
1612415|NCT02527161|2960181|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Change in SF-12 Mental Component score from preoperative to 6 months.|
1612416|NCT02527161|2960181|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Change in SF-12 Physical Component Score from preoperative to 6 months.|
1612417|NCT02527161|2960183|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in KOOS QOL score from preoperative to 2 years.|
1614333|NCT02494401|2963014|Superiority|||||||0.23|||||||Wilcoxon (Mann-Whitney)||||
1612396|NCT02528188|2960152|Superiority|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.02|Standard Error of the Mean|0.04||0.6332|2-Sided|95.0|-0.09|0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612397|NCT02528188|2960152|Superiority|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.04|Standard Error of the Mean|0.04||0.3431|2-Sided|95.0|-0.11|0.04||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline PGA and baseline diary average pain as covariates, and study site as a random effect.|
1612398|NCT02528188|2960153|Superiority|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.19|Standard Error of the Mean|0.11||0.0691|2-Sided|95.0|-0.4|0.02||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612399|NCT02528188|2960153|Superiority|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.31|Standard Error of the Mean|0.1||0.003|2-Sided|95.0|-0.52|-0.11||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC physical function subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612400|NCT02528188|2960154|Superiority|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.15|Standard Error of the Mean|0.11||0.1597|2-Sided|95.0|-0.36|0.06||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. Analysis of covariance (ANCOVA) model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612401|NCT02528188|2960154|Superiority|A graphical testing procedure was applied to maintain Type I error. Tanezumab 5 mg versus NSAID was tested first and if all primary endpoints were found significant, then the testing was continued for Tanezumab 2.5 mg versus NSAID and the key secondary endpoint (>=50% reduction from baseline in WOMAC Pain at Week 16). Primary endpoints were tested sequentially within a dose in order of WOMAC pain, WOMAC physical function, and PGA.|LS Mean Difference|-0.26|Standard Error of the Mean|0.11||0.0148|2-Sided|95.0|-0.46|-0.05||Threshold for significance at 0.05 level.|ANCOVA|||Multiple imputation method was applied for missing data, with imputation dependent on reason for missing data. ANCOVA model for imputed datasets included treatment, randomization stratification variables (index joint, highest Kellgren-Lawrence grade and NSAID) as fixed effects, baseline WOMAC pain subscale and baseline diary average pain as covariates, and study site as a random effect.|
1612402|NCT02528188|2960155|Superiority||Rate Difference|56.7|||<|0.0001|2-Sided|95.0|38.4|74.9|||Poisson model for rate difference||||
1612403|NCT02528188|2960155|Superiority||Rate Difference|23.5|||<|0.0012|2-Sided|95.0|9.3|37.7|||Poisson model for rate difference||||
1612404|NCT02528188|2960156|Superiority||Risk Difference (RD)|5.61|||<|0.0001|2-Sided|95.0|3.55|8.14|||Exact methods for risk difference||||
1612405|NCT02528188|2960156|Superiority||Risk Difference (RD)|2.39|||<|0.0123|2-Sided|95.0|0.58|4.68|||Exact methods for risk difference||||
1612406|NCT02527161|2960175|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in Pain during mobilization from preoperative to 2 years.|
1612407|NCT02527161|2960175|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in Pain at rest from preoperative to 2 years.|
1612408|NCT02527161|2960176|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in Pain during mobilization from preoperative to 12 months.|
1612409|NCT02527161|2960176|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in Pain at rest from preoperative to 12 months.|
1612410|NCT02527161|2960177|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Change in Pain during mobilization from preoperative to 6 months.|
1612411|NCT02527161|2960177|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Change in Pain at rest from preoperative to 6 months.|
1612427|NCT02527161|2960185|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Change in KOOS QOL score from preoperative to 6 months.|
1612428|NCT02527161|2960185|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Change in KOOS Sport score from preoperative to 6 months.|
1612429|NCT02527161|2960185|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Change in KOOS ADL score from preoperative to 6 months.|
1612430|NCT02527161|2960185|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Change in KOOS Symptoms score from preoperative to 6 months.|
1612431|NCT02527161|2960185|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Change in KOOS Pain score from preoperative to 6 months.|
1612432|NCT02527161|2960189|Superiority or Other|||||||0.8777|||||||t-test, 2 sided|||Change from 12 months to 24 months for the Forgotten Joint Score.|
1612433|NCT02527161|2960191|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Change from preoperative to 6 months KSS function.|
1612434|NCT02527161|2960191|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Change from preoperative to 6 months KSS Pain/Motion|
1612435|NCT02527161|2960192|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1612436|NCT02526524|2960219|Superiority||LS Mean|-1.03|Standard Error of the Mean|0.184|<|0.0001|2-Sided|95.0|-1.39|-0.67|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.|||
1612437|NCT02526524|2960219|Superiority||LS Mean|-0.55|Standard Error of the Mean|0.18|<|0.0022|2-Sided|95.0|-0.91|-0.2|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.|||
1612438|NCT02526524|2960219|Superiority||LS Means|-0.42|Standard Error of the Mean|0.184|<|0.0214|2-Sided|95.0|-0.79|-0.06|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.|||
1612439|NCT02526524|2960219|Superiority||LS Mean|-0.33|Standard Error of the Mean|0.18|<|0.0643|2-Sided|95.0|-0.69|0.02|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.|||
1612440|NCT02526524|2960219|Superiority||LS Mean|-0.27|Standard Error of the Mean|0.184|<|0.1449|2-Sided|95.0|-0.63|0.09|||Mixed Models Analysis|Included treatment, visit, and treatment-by-visit interaction as fixed effects, and HbA1c value at Baseline as a covariate.|||
1612441|NCT02525094|2960293|Superiority||Odds Ratio (OR)|1.97|||||2-Sided|95.0|0.9|4.33|||||||
1612442|NCT02524977|2960297|Superiority or Other|||||||0.02|||||||Chi-squared||||
1612443|NCT02524665|2960298|Superiority or Other|||||||0.1573||||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 8.|McNemar||||
1612444|NCT02524665|2960298|Superiority or Other|||||||0.3173||||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 8.|McNemar||||
1612445|NCT02524665|2960298|Superiority or Other|||||||1||||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 4.|McNemar||||
1612446|NCT02524665|2960298|Superiority or Other|||||||0.4795||||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 4.|McNemar||||
1612447|NCT02524665|2960298|Superiority or Other|||||||1||||||Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 2.|McNemar||||
1612448|NCT02524665|2960298|Superiority or Other|||||||0.5637||||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 2.|McNemar||||
1612449|NCT02524665|2960298|Superiority or Other|||||||0||||||The value is mentioned as '0', as no P-value generated. Comparison of two or more grade improvement between MAXCLARITY II and Murad at Week 1.|McNemar||||
1612450|NCT02524665|2960298|Superiority or Other|||||||1||||||Comparison of one or more grade improvement between MAXCLARITY II and Murad at Week 1.|McNemar||||
1612451|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Deviation|0.81||1||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 8.||
1612452|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Deviation|0.93||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 4.||
1612453|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Deviation|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 2.||
1612454|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Deviation|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Scaling score between MAXCLARITY II and Murad at Week 1.||
1612455|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Deviation|0.82||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 8.||
1612456|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Deviation|1.01||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 4.||
1612457|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Deviation|0.74||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 2.||
1612458|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.21|Standard Deviation|0.54||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Itching score between MAXCLARITY II and Murad at Week 1.||
1612459|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Deviation|0.73||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 8.||
1612460|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.21|Standard Deviation|0.98||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 4.||
1612461|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Deviation|0.74||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 2.||
1612462|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Deviation|0.62||1||95.0|||||Wilcoxon signed-rank test||Comparison of Burning score between MAXCLARITY II and Murad at Week 1.||
1612463|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Deviation|0.82||0.25||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.||
1612464|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Deviation|0.93||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.||
1612465|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Deviation|0.94||0.5742||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.||
1612466|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Deviation|0.88||0.8125||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.||
1612467|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.16|Standard Deviation|0.69||1||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 8.||
1612468|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|-0.21|Standard Deviation|0.92||1||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 4.||
1612469|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Deviation|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 2.||
1612470|NCT02524665|2960299|Superiority or Other||Mean Difference (Final Values)|0.21|Standard Deviation|0.63||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Redness score between MAXCLARITY II and Murad at Week 1.||
1612471|NCT02524665|2960300|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Deviation|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 8.||
1612472|NCT02524665|2960300|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Deviation|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 4.||
1612473|NCT02524665|2960300|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Deviation|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 2.||
1612474|NCT02524665|2960300|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Deviation|0.69||1||95.0|||||Wilcoxon signed-rank test||Comparison of Peeling score between MAXCLARITY II and Murad at Week 1.||
1612475|NCT02524665|2960300|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Deviation|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 8.||
1612476|NCT02524665|2960300|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Deviation|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 4.||
1612477|NCT02524665|2960300|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Deviation|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 2.||
1612478|NCT02524665|2960300|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Deviation|0.74||1||95.0|||||Wilcoxon signed-rank test||Comparison of Dryness score between MAXCLARITY II and Murad at Week 1.||
1612479|NCT02524665|2960300|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Deviation|0.0||0||95.0||||The value is mentioned as '0', as no P-value generated.|Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 8.||
1612480|NCT02524665|2960300|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Deviation|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 4.||
1612481|NCT02524665|2960300|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Deviation|0.52||1||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 2.||
1612482|NCT02524665|2960300|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Deviation|0.5||0.5||95.0|||||Wilcoxon signed-rank test||Comparison of Erythema score between MAXCLARITY II and Murad at Week 1.||
1612483|NCT02524665|2960301|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Deviation|0.87||0.3071||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 8||
1612484|NCT02524665|2960301|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Deviation|0.74||0.7539||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 4.||
1612485|NCT02524665|2960301|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Deviation|0.66||0.75||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 2.||
1612486|NCT02524665|2960301|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Deviation|0.23||1||95.0|||||Wilcoxon signed-rank test||Comparison of ISGA score between MAXCLARITY II and Murad at Week 1||
1612487|NCT02524665|2960302|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Deviation|17.83||0.9616||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 4.||
1612488|NCT02524665|2960302|Superiority or Other||Mean Difference (Final Values)|-1.22|Standard Deviation|22.97||0.8199||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 2.||
1612489|NCT02524665|2960302|Superiority or Other||Mean Difference (Final Values)|5.72|Standard Deviation|26.05||0.3513||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change total lesion counts between MAXCLARITY II and Murad at Week 1.||
1612606|NCT02516605|2960933|Other||Median difference from baseline|-10.9|Standard Error of the Mean|8.59||0.21|2-Sided|90.0|-25.29|3.48|||ANCOVA|Day 84|||
1614334|NCT02494401|2963014|Superiority|||||||0.83||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)||||
1612490|NCT02524665|2960302|Superiority or Other||Mean Difference (Final Values)|7.41|Standard Deviation|35.46||0.9323||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.||
1612491|NCT02524665|2960302|Superiority or Other||Mean Difference (Final Values)|8.99|Standard Deviation|39.59||0.3352||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.||
1612492|NCT02524665|2960302|Superiority or Other||Mean Difference (Final Values)|10.98|Standard Error of the Mean|46.04||0.6722||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.||
1612493|NCT02524665|2960302|Superiority or Other||Mean Difference (Final Values)|-4.03|Standard Deviation|65.22||0.8894||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 4.||
1612494|NCT02524665|2960302|Superiority or Other||Mean Difference (Final Values)|-29.11|Standard Deviation|99.76||0.2464||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 2.||
1612495|NCT02524665|2960302|Superiority or Other||Mean Difference (Final Values)|-3.1|Standard Deviation|74.55||0.5031||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of percent change inflammatory lesion counts between MAXCLARITY II and Murad at Week 1.||
1612496|NCT02524665|2960303|Superiority or Other||Mean Difference (Final Values)|-1.66|Standard Deviation|17.59||0.6854||95.0||||Percent change from baseline were analyzed using the individual differences between both sides of the face at an alpha level of 0.05 using paired t-tests.|t-test, 2 sided||Comparison of total lesion counts between MAXCLARITY II and Murad at Week 8.||
1612497|NCT02524665|2960303|Superiority or Other||Mean Difference (Final Values)|7.77|Standard Deviation|33.73||0.6698||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used.|Wilcoxon signed-rank test||Comparison of non-inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.||
1612498|NCT02524665|2960303|Superiority or Other||Mean Difference (Final Values)|-14.67|Standard Deviation|61.97||0.0769||95.0||||The assumption of normality was verified using a Shapiro-Wilk Test. If the assumption of normality was rejected (at the 0.01 level), a non-parametric method (Wilcoxon signed-rank test) was used|Wilcoxon signed-rank test||Comparison of inflammatory lesion counts between MAXCLARITY II and Murad at Week 8.||
1612499|NCT02524158|2960322|Superiority|||||||0.071|||||||ANCOVA||||
1612500|NCT02524158|2960323|Superiority|||||||0.036||||||The a priori specified threshold is p < 0.05|ANCOVA||||
1612501|NCT02524158|2960324|Superiority|||||||0.92|||||||ANCOVA||||
1612502|NCT02524158|2960325|Superiority|||||||0.071|||||||ANCOVA||||
1612503|NCT02524158|2960327|Superiority|||||||0.067|||||||ANCOVA||||
1612504|NCT02524158|2960328|Superiority|||||||0.5|||||||ANCOVA||||
1612505|NCT02524158|2960329|Superiority|||||||0.369|||||||ANCOVA||||
1612506|NCT02524158|2960330|Superiority|||||||0.202|||||||ANCOVA||||
1612507|NCT02524158|2960331|Superiority||||||<|0.1|||||||Mixed Models Analysis||||
1612508|NCT02524158|2960332|Superiority|||||||0.66|||||||ANCOVA||||
1612509|NCT02524158|2960333|Superiority|||||||0.01||||||The a priori specified threshold is p < 0.05|ANCOVA||||
1612510|NCT02524158|2960334|Superiority||||||<|0.01|||||||ANCOVA||||
1612511|NCT02524158|2960335|Superiority|||||||0.044||||||The a priori specified threshold is p < 0.05|ANCOVA||||
1612512|NCT02524158|2960336|Superiority|||||||0.013|||||||Mixed Models Analysis||||
1612513|NCT02524158|2960337|Superiority|||||||0.005||||||The a priori specified threshold is p < 0.05|Mixed Models Analysis||||
1612514|NCT02524158|2960338|Superiority|||||||0.003|||||||Mixed Models Analysis||||
1612515|NCT02524158|2960339|Superiority|||||||0.34|||||||Mixed Models Analysis||||
1612516|NCT02524106|2960342|Other||percentage difference|39.0||||0.096|2-Sided||||||Mixed Models Analysis||||
1612517|NCT02524106|2960343|Other||percentage difference|61.0||||0.028|2-Sided||||||Mixed Models Analysis||||
1612518|NCT02524054|2960344|Superiority||||||<|0.001||||||The p-value is not adjusted for multiple comparisons, and the a priori threshold for significance was 0.05.|t-test, 2 sided||||
1612519|NCT02524054|2960345|Superiority|||||||0.35||||||The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||This is a paired t-test comparing the treatment effect of furosemide to the treatment effect of saline in each individual.|
1612520|NCT02522624|2960376|Superiority or Other|||||||0.46|||||||Regression, Linear|||Controlling for numeracy.|
1612521|NCT02522624|2960376|Superiority or Other|||||||0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).|
1612522|NCT02522624|2960376|Superiority or Other||Odds Ratio (OR)|10.32|||<|0.001|2-Sided|95.0|5.94|17.95||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic||||
1612524|NCT02522624|2960377|Superiority or Other|||||||0.39||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).|
1612525|NCT02522624|2960377|Superiority or Other||Odds Ratio (OR)|2.52|||<|0.001|2-Sided|95.0|1.58|4.01||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic||||
1612526|NCT02522624|2960378|Superiority or Other|||||||0.58|||||||Regression, Linear|||Controlling for Numeracy.|
1612527|NCT02522624|2960378|Superiority or Other|||||||0.26|||||||Regression, Logistic|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).|
1612528|NCT02522624|2960378|Superiority or Other||Odds Ratio (OR)|1.48||||0.1|2-Sided|95.0|0.92|2.36||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Logistic||||
1612529|NCT02522624|2960379|Superiority or Other|||||||0.15|||||||Regression, Linear|||Controlling for Numeracy.|
1612530|NCT02522624|2960379|Superiority or Other|||||||0.82|||||||Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).|
1612531|NCT02522624|2960379|Superiority or Other||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear||||
1612532|NCT02522624|2960380|Superiority or Other|||||||0.82|||||||Regression, Linear|||Controlling for Numeracy.|
1612533|NCT02522624|2960380|Superiority or Other|||||||0.3|||||||Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).|
1612534|NCT02522624|2960380|Superiority or Other|||||||0.002||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear||||
1612535|NCT02522624|2960381|Superiority or Other||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||Controlling for Numeracy.|
1612536|NCT02522624|2960381|Superiority or Other||||||<|0.16||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear|||Examined the relation between group and categorical outcomes, controlling for % Federal Poverty Level (400 or greater, 250-399, 100-249, less than 100).|
1612537|NCT02522624|2960381|Superiority or Other||||||<|0.001||||||A priori sample size estimates yielded an estimate of 183 per group needed to detect an effect size of 0.34 with 90% power at a 0.05 level of significance and 137 per group with 80% power.|Regression, Linear||||
1612538|NCT02522442|2960385|Other|Pilot study, not powered for any endpoint.||||||0.624|||||||Chi-squared||||
1612539|NCT02522442|2960386|Other|Pilot study, not powered for any endpoint.||||||0.377|||||||Chi-squared|||Pilot study, not powered for any endpoint.|
1612540|NCT02522377|2960390|Superiority||Odds Ratio (OR)|0.36||||0.58|2-Sided|95.0|0.01|7.2|||Fisher Exact||Odds Ratio of Midazolam (numerator) to Ketamine Infusions (denominator)||
1612541|NCT02522377|2960391|Superiority|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|3.72|Standard Error of the Mean|3.71||0.34|2-Sided||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions||
1612542|NCT02522377|2960392|Superiority|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|1.78|Standard Error of the Mean|0.54||0.009|2-Sided||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.3634.|Midazolam - Ketamine Infusions||
1612543|NCT02522377|2960393|Superiority|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|0.98|Standard Error of the Mean|1.12||0.4|2-Sided||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions||
1612544|NCT02522377|2960394|Superiority|Superiority test based upon group differences pooled across infusions in mixed effect model|Mean Difference (Final Values)|1.98|Standard Error of the Mean|6.4||0.77|2-Sided||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=7.836.|Midazolam - Ketamine Infusions||
1612545|NCT02522377|2960395|Superiority|Superiority test based upon group differences pooled across infusions|Mean Difference (Final Values)|1.22|Standard Error of the Mean|3.28||0.72|2-Sided||||||Mixed Models Analysis|Model includes main effect for treatment group and infusion number categorically. Satterthwaite DF=9.987.|Midazolam - Ketamine Infusions||
1612546|NCT02521376|2960458|Other||GMR|107.35|||||2-Sided|90.0|72.71|158.51|||||||
1612547|NCT02521376|2960458|Other||GMR|171.33|||||2-Sided|90.0|108.17|271.37|||||||
1612548|NCT02521376|2960458|Other||GMR|211.94|||||2-Sided|90.0|132.49|339.03|||||||
1612549|NCT02521376|2960458|Other||GMR|55.71|||||2-Sided|90.0|34.7|89.42|||||||
1612550|NCT02521376|2960459|Other||GMR|108.5|||||2-Sided|90.0|77.2|152.48|||||||
1612551|NCT02521376|2960459|Other||GMR|219.2|||||2-Sided|90.0|139.74|343.84|||||||
1612552|NCT02521376|2960459|Other||GMR|233.63|||||2-Sided|90.0|141.85|384.79|||||||
1612553|NCT02521376|2960459|Other||Geometric Mean Ratio (GMR)|43.69|||||2-Sided|90.0|24.59|77.62|||||||
1612554|NCT02520388|2960482|Superiority|||||||0.05|||||||Mixed model repeated measures analysis||||
1612555|NCT02520388|2960483|Superiority|||||||0.05|||||||Mixed model repeated measures analysis||||
1614335|NCT02494401|2963014|Superiority|||||||0.68||||||p value baseline comparison|Wilcoxon (Mann-Whitney)||||
1612556|NCT02519855|2960718|Non-Inferiority or Equivalence|A lower bound of the 95% CI on the fold difference (GMT ratio [Concomitant / Nonconcomitant] at 4 weeks postvaccination) >0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|0.99|||<|0.001|2-Sided|95.0|0.87|1.13|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.|||
1612557|NCT02519855|2960719|Non-Inferiority or Equivalence|A lower bound of the 95% CI on the fold difference (GMT ratio [Concomitant / Nonconcomitant] at 4 weeks postvaccination) >0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.0|||<|0.001|2-Sided|95.0|0.88|1.14|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.|||
1612558|NCT02519855|2960720|Non-Inferiority or Equivalence|A lower bound of the 95% CI on the fold difference (GMT ratio [Concomitant / Nonconcomitant] at 4 weeks postvaccination) >0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.1|||<|0.001|2-Sided|95.0|0.94|1.29|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.|||
1612559|NCT02519855|2960721|Non-Inferiority or Equivalence|A lower bound of the 95% CI on the fold difference (GMT ratio [Concomitant / Nonconcomitant] at 4 weeks postvaccination) >0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported the conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|1.02|||<|0.001|2-Sided|95.0|0.88|1.18|||Longitudinal regression|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.|||
1612560|NCT02519855|2960722|Superiority or Other||GMFR from Baseline|1.9|||<|0.001|2-Sided|95.0|1.76|2.05||A lower bound of the 95% CI on the GMFR > 1.4 indicated that the Concomitant Group induces an acceptable VZV antibody response. A p-value ≤0.025 also supported this conclusion.|Longitudinal regression||Estimated GMFR, 95% CI and p-value were based on a longitudinal regression model adjusting for age.||
1612561|NCT02519855|2960723|Non-Inferiority or Equivalence|A lower bound of the 95% CI on the fold difference (GMT ratio [Concomitant / Nonconcomitant] at 4 weeks postvaccination) >0.67 implied that the difference is statistically significantly noninferior to the prespecified clinically relevant decrease of 1.5-fold. A p-value ≤0.025 also supported a conclusion of noninferiority.|GMT Ratio at 4 weeks postvaccination|0.87|||<|0.001|2-Sided|95.0|0.8|0.95|||Longitudinal regression model|GMT ratio, 95% CI and p-value were based on a longitudinal regression model adjusting for prevaccination titers and age.|||
1612562|NCT02519842|2960727|Other||Mean Difference (Final Values)|5.4|||||2-Sided|95.0|-5.1|17.8|||||Mean difference in percentage of participants who discontinued due to an AE and received fosaprepitant regimen compared with participants who received control regimen.||
1612563|NCT02519842|2960728|Other||Mean Difference (Final Values)|9.8|||||2-Sided|95.0|-7.6|27.9|||||Mean difference in percentage of participants who experienced at least 1 tier 2 AE and received fosaprepitant regimen compared with participants who received control regimen.||
1612564|NCT02519595|2960731|Superiority or Other|||||||0.011|||||||Chi-squared||||
1612565|NCT02519595|2960732|Superiority or Other|||||||0.5|||||||Chi-squared|||Post discharge Emesis|
1612566|NCT02519595|2960732|Superiority or Other|||||||0.8|||||||Chi-squared|||Adverse events in ED|
1612567|NCT02519595|2960734|Superiority or Other|||||||0.2|||||||Kruskal-Wallis||||
1612568|NCT02519595|2960735|Superiority or Other|||||||0.09|||||||Kruskal-Wallis||||
1612569|NCT02519595|2960736|Superiority or Other|||||||0.2|||||||Kruskal-Wallis||||
1612570|NCT02518971|2960820|Other|||||||0.207|||||||Student T-test||||
1612571|NCT02518971|2960821|Other|||||||0.497|||||||Fisher Exact||||
1612572|NCT02518971|2960822|Other|||||||1|||||||Fisher Exact||||
1612573|NCT02518971|2960823|Other|||||||0.378|||||||Student T-Test||||
1612574|NCT02518971|2960824|Other|||||||0.345|||||||Chi-squared||||
1612575|NCT02518685|2960835|Superiority|Statistical success criterion for achieving the performance standard of (≥ 50%) of proportion of TPS subjects who have 5% or more TBL at the 12-Month Follow-up|Proportion of Subjects|66.8|||<|0.0001|2-Sided|95.0|59.3|74.3|||Wilson's Midpoint Estimate||||
1612576|NCT02518685|2960836|Superiority||Least-Square Mean Difference|6.7|||<|0.0001|2-Sided|95.0|4.54|8.81|||multiple imputations||||
1612577|NCT02518048|2960858|Superiority or Other||Mean Difference (Final Values)|-0.55|||<|0.001|2-Sided|95.0|-0.69|-0.41||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)|ANOVA|||Echo-Poor Band Thickness: LEO 90100 vs. Betesil®|
1612578|NCT02518048|2960858|Superiority or Other||Mean Difference (Final Values)|-0.42|||<|0.001|2-Sided|95.0|-0.53|-0.32||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group)|ANOVA|||Total Skin Thickness: LEO 90100 vs. Betesil®|
1612579|NCT02518048|2960861|Superiority or Other||Mean Difference (Final Values)|-2.17|||<|0.001|2-Sided|95.0|-2.58|-1.76||Least Square Means difference from ANOVA with treatment group as fixed effect and subject as random effect (105 treated sites per treatment group).|ANOVA|||A last observation carried forward (LOCF) approach was used to account for drop-outs and missing values in the analysis of end of treatment values.|
1612607|NCT02516605|2960933|Other||Median difference from baseline|-1.75|Standard Error of the Mean|7.19||0.809|2-Sided|90.0|-13.8|10.31|||ANCOVA|Day 56|||
1612608|NCT02516605|2960933|Other||Median difference from baseline|14.05|Standard Error of the Mean|9.184||0.132|2-Sided|90.0|-1.35|29.44|||ANCOVA|Day 28|||
1612609|NCT02516605|2960933|Other||Median difference from baseline|16.79|Standard Error of the Mean|8.707||0.059|2-Sided|90.0|2.2|31.38|||ANCOVA|day 21|||
1612610|NCT02516605|2960933|Other||Median difference from baseline|7.74|Standard Error of the Mean|8.226||0.351|2-Sided|90.0|-6.05|21.52|||ANCOVA|Day 14|||
1612580|NCT02517515|2960901|Superiority|The superiority of the rate of sustained virologic response at 24 weeks after treatment (SVR24) for the treatment-experienced participants in the double-blind 3-DAA group as compared with the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with SVR24 must exceed 75% to achieve superiority.|percentage of participants|100.0|||||2-Sided|95.0|97.4|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided >90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).|
1612581|NCT02517515|2960901|Superiority|The superiority of the rate of sustained virologic response at 24 weeks after treatment (SVR24) for the treatment-naïve participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR24 must exceed 84% to achieve superiority.|percentage of participants|99.5|||||2-Sided|95.0|97.0|99.9||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided >90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).|
1612582|NCT02517515|2960902|Superiority|The superiority of the rate of sustained virologic response at 12 weeks after treatment for the treatment-experienced participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|percentage of participants|100.0|||||2-Sided|95.0|97.4|100.0||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-experienced group, the sample size 180 treatment-experienced participants provided >90% power to demonstrate superiority of the regimen to the historical rate for treatment-experienced patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).|
1612583|NCT02517515|2960902|Superiority|The superiority of the rate of sustained virologic response at 12 weeks after treatment (SVR12) for the treatment-naïve participants in the Double-blind 3-DAA group as compared with the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with SVR12 must exceed 84% to achieve superiority.|percentage of participants|99.5|||||2-Sided|95.0|97.0|99.9||||||Based on a 2-sided significance level of 0.05 and an underlying rate of 96% for the Double-blind 3-DAA treatment-naïve group, the sample size 180 treatment-naïve participants provided >90% power to demonstrate superiority of the regimen to the historical rate for treatment-naïve patients treated with TVR + pegIFN + RBV (80%) (based on one-sample chi-square test of a single binomial proportion for superiority).|
1612584|NCT02517463|2960903|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1612585|NCT02517463|2960904|Superiority or Other|||||||0.564|||||||Fisher Exact||||
1612586|NCT02517463|2960905|Non-Inferiority or Equivalence|The PPP from a previous study was 67.2%. Assuming the PPP in the “preovulatory” and “post-ovulatory” groups were equivalent, and taking 10% to be the maximum permitted difference for equivalence, a minimum of 273 subjects in each group would be required to confirm equivalence between the two groups with a power of 80% and type I error of 0.05. Therefore, our recruitment of 700 subjects with more than 300 in each group was sufficient.|||||<|0.0001|||||||Chi-squared||||
1612587|NCT02516982|2960926|Superiority|||||||0.869|||||||Chi-squared, Corrected||||
1612588|NCT02516982|2960927|Superiority|||||||0.024|||||||Wilcoxon (Mann-Whitney)||||
1612589|NCT02516982|2960928|Superiority|||||||0.0001467|||||||Chi-squared, Corrected||||
1612590|NCT02516982|2960929|Superiority|||||||0.919|||||||Chi-squared, Corrected||||
1612591|NCT02516982|2960930|Superiority|||||||0.008|||||||Chi-squared, Corrected||||
1612592|NCT02516982|2960931|Superiority|||||||0.7|||||||Wilcoxon (Mann-Whitney)||||
1612593|NCT02516982|2960932|Superiority|||||||0.994|||||||Chi-squared, Corrected||||
1612594|NCT02516605|2960933|Other||Median difference from baseline|-16.93|Standard Error of the Mean|8.961||0.064|2-Sided|90.0|-31.94|-1.92|||ANCOVA|Day 84|||
1612595|NCT02516605|2960933|Other||Median difference from baseline|-11.08|Standard Error of the Mean|7.69||0.156|2-Sided|90.0|-23.95|1.8|||ANCOVA|Day 56|||
1612596|NCT02516605|2960933|Other||Median difference from baseline|8.91|Standard Error of the Mean|10.911||0.418|2-Sided|90.0|-9.34|27.15|||ANCOVA|Day 28|||
1612597|NCT02516605|2960933|Other||Median difference from baseline|5.9|Standard Error of the Mean|10.014||0.558|2-Sided|90.0|-10.86|22.66|||ANCOVA|Day 21|||
1612598|NCT02516605|2960933|Other||Median difference from baseline|8.17|Standard Error of the Mean|9.032||0.37|2-Sided|90.0|-6.96|23.29|||ANCOVA|Day 14|||
1612599|NCT02516605|2960933|Other||Median difference from baseline|26.7|Standard Error of the Mean|8.799||0.004|2-Sided|90.0|11.97|41.44|||ANCOVA|Day 7|||
1612600|NCT02516605|2960933|Other||Median difference from baseline|-18.23|Standard Error of the Mean|8.11||0.029|2-Sided|90.0|-31.81|-4.64|||ANCOVA|Day 84|||
1612601|NCT02516605|2960933|Other||Median difference from baseline|-13.82|Standard Error of the Mean|6.797||0.047|2-Sided|90.0|-25.21|-2.43|||ANCOVA|day 56|||
1612602|NCT02516605|2960933|Other||Median difference from baseline|0.19|Standard Error of the Mean|8.697||0.982|2-Sided|90.0|-14.38|14.77|||ANCOVA|Day 28|||
1612603|NCT02516605|2960933|Other||Median difference from baseline|5.02|Standard Error of the Mean|8.244||0.545|2-Sided|90.0|-8.79|18.83|||ANCOVA|day 21|||
1612604|NCT02516605|2960933|Other||Median difference from baseline|0.48|Standard Error of the Mean|7.787||0.951|2-Sided|90.0|-12.57|13.53|||ANCOVA|Day 14|||
1612605|NCT02516605|2960933|Other||Median difference from baseline|13.92|Standard Error of the Mean|7.963||0.086||90.0|0.58|27.25|||ANCOVA|day 7|||
1615067|NCT02473471|2964572|Other|||||||0.582|||||||t-test, 2 sided|||Day 3 after intervention|
1612611|NCT02516605|2960933|Other||Median difference from baseline|11.34|Standard Error of the Mean|8.434||0.185|2-Sided|90.0|-2.78|25.46|||ANCOVA|Day 7|||
1612612|NCT02516605|2960933|Other||Median difference from baseline|-16.93|Standard Error of the Mean|8.592||0.054|2-Sided|90.0|-31.31|-2.54|||ANCOVA|Day 84|||
1612613|NCT02516605|2960933|Other||Median difference from baseline|-15.25|Standard Error of the Mean|7.192||0.039|2-Sided|90.0|-27.3|-3.19|||ANCOVA|Day 56|||
1612614|NCT02516605|2960933|Other||Median difference from baseline|7.03|Standard Error of the Mean|9.187||0.448|2-Sided|90.0|-8.36|22.43|||ANCOVA|Day 28|||
1612615|NCT02516605|2960933|Other||Median difference from baseline|7.78|Standard Error of the Mean|8.71||0.376|2-Sided|90.0|-6.81|22.38|||ANCOVA|Day 21|||
1612616|NCT02516605|2960933|Other||Median difference from baseline|-14.07|Standard Error of the Mean|8.229||0.093|2-Sided|90.0|-27.85|-0.28|||ANCOVA|Day 14|||
1612617|NCT02516605|2960933|Other||Mean difference from baseline|-2.78|Standard Error of the Mean|8.436||0.743|2-Sided|90.0|-16.91|11.34|||ANCOVA|Day 7|||
1612618|NCT02516605|2960934|Other||Median difference from baseline|0.0||||0.602|2-Sided|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84|||
1612619|NCT02516605|2960934|Other||Median difference from baseline|0.0||||0.975|2-Sided|90.0|-1.0|1.0|||Wilcoxon rank-sum test|Day 56|||
1612620|NCT02516605|2960934|Other||Median difference from baseline|2.0||||0.142|2-Sided|90.0|0.0|5.0|||Wilcoxon rank-sum test|Day 28|||
1612621|NCT02516605|2960934|Other||Median difference|0.0||||1|2-Sided|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84|||
1612622|NCT02516605|2960934|Other||Median difference from baseline|0.0||||0.717|2-Sided|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 56|||
1612623|NCT02516605|2960934|Other||Median difference from baseline|2.0||||0.102|2-Sided|90.0|0.0|4.0|||Wilcoxon rank-sum test|Day 28|||
1612624|NCT02516605|2960934|Other||Median difference from baseline|0.0||||0.979|2-Sided|90.0|-2.0|1.0|||Wilcoxon rank-sum test|Day 84|||
1612625|NCT02516605|2960934|Other||Median difference from baseline|1.0||||0.292|2-Sided|90.0|0.0|2.0|||Wilcoxon rank-sum test|Day 56|||
1612626|NCT02516605|2960934|Other||Median difference from baseline|1.0||||0.132|2-Sided|90.0|0.0|2.0|||Wilcoxon rank-sum test|Day 28|||
1612627|NCT02516605|2960934|Other||Median difference from baseline|-1.0||||0.377|2-Sided|90.0|-3.0|0.0|||Wilcoxon rank-sum test|Day 84|||
1612628|NCT02516605|2960934|Other||Median difference from baseline|0.0||||0.699|2-Sided|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 56|||
1612629|NCT02516605|2960934|Other||Median difference from baseline|1.0||||0.342|2-Sided|90.0|-1.0|2.0|||Wilcoxon rank-sum test|Day 28|||
1612630|NCT02516605|2960935|Other||Median difference from baseline|-3.5||||0.397|2-Sided|90.0|-11.0|3.0|||Wilcoxon rank-sum test|Day 84|||
1612631|NCT02516605|2960935|Other||Median difference from baseline|-11.0||||0.037|2-Sided|90.0|-21.0|-1.0|||Wilcoxon rank-sum test|Day 56|||
1612632|NCT02516605|2960935|Other||Median difference from baseline|2.0||||0.605|2-Sided|90.0|-2.0|9.0|||Wilcoxon rank-sum test|Day 28|||
1612633|NCT02516605|2960935|Other||Median difference from baseline|-6.5||||0.192|2-Sided|90.0|-15.0|1.0|||Wilcoxon rank-sum test|Day 84|||
1612634|NCT02516605|2960935|Other||Median difference from baseline|-6.0||||0.236|2-Sided|90.0|-14.0|1.0|||Wilcoxon rank-sum test|Day 56|||
1612635|NCT02516605|2960935|Other||Median difference from baseline|4.0||||0.297|2-Sided|90.0|-3.0|8.0|||Wilcoxon rank-sum test|Day 28|||
1612636|NCT02516605|2960935|Other||Median difference from baseline|-1.0||||0.838|2-Sided|90.0|-10.0|8.0|||Wilcoxon rank-sum test|Day 84|||
1612637|NCT02516605|2960935|Other||Median difference from baseline|-2.0||||0.702|2-Sided|90.0|-12.0|4.0|||Wilcoxon rank-sum test|Day 56|||
1612638|NCT02516605|2960935|Other||Median difference from baseline|1.5||||0.591|2-Sided|90.0|-5.0|7.0|||Wilcoxon rank-sum test|Day 28|||
1612639|NCT02516605|2960935|Other||Median difference from baseline|-3.0||||0.509|2-Sided|90.0|-11.0|4.0|||Wilcoxon rank-sum test|Day 84|||
1612640|NCT02516605|2960935|Other||Median difference from baseline|2.0||||0.593|2-Sided|90.0|-4.0|10.0|||Wilcoxon rank-sum test|Day 56|||
1612641|NCT02516605|2960935|Other||Median difference from baseline|1.0||||0.898|2-Sided|90.0|-7.0|6.0|||Wilcoxon rank-sum test|Day 28|||
1612642|NCT02516605|2960945|Other||adjusted fold change from baseline|0.36|||<|0.001|2-Sided|90.0|0.27|0.47|||ANCOVA||||
1612643|NCT02516605|2960945|Other||adjusted fold change from baseline|0.32|||<|0.001|2-Sided|90.0|0.26|0.4|||ANCOVA||||
1612644|NCT02516605|2960945|Other||adjusted fold change from baseline|0.47|||<|0.001|2-Sided|90.0|0.37|0.6|||ANCOVA||||
1612645|NCT02516605|2960945|Other||adjusted fold change from baseline|0.86|||<|0.293|2-Sided|90.0|0.68|1.09|||ANCOVA||||
1612646|NCT02516592|2960946|Superiority||Mean Difference (Final Values)|-0.04||||0.662|2-Sided|95.0|-0.2|0.13|||Mixed Models Analysis||||
1612647|NCT02516592|2960947|Superiority||Mean Difference (Final Values)|-0.4||||0.319|2-Sided|95.0|-1.3|0.4|||Mixed Models Analysis||||
1612648|NCT02516592|2960948|Superiority||Mean Difference (Final Values)|0.102||||0.002|2-Sided|95.0|0.037|0.167|||Mixed Models Analysis||||
1612649|NCT02516592|2960949|Superiority||Mean Difference (Final Values)|0.46||||0.063|2-Sided|95.0|-0.03|0.94|||Mixed Models Analysis||||
1612650|NCT02516592|2960950|Superiority||Mean Difference (Final Values)|0.045||||0.028|2-Sided|95.0|0.005|0.084|||Mixed Models Analysis||||
1612651|NCT02516410|2960965|Superiority||Least squares (LS) mean difference|1.2|||=|0|2-Sided|95.0|-0.3|2.6|||Mixed-effect repeated measure (MMRM)||||
1612652|NCT02516202|2960967|Superiority|||||||0.95|||||||Chi-squared||||
1612653|NCT02516202|2960967|Superiority||||||<|0.001|||||||Chi-squared||||
1612654|NCT02516202|2960968|Superiority|||||||0.6|||||||Chi-squared||||
1612655|NCT02516202|2960968|Superiority||||||<|0.001|||||||Chi-squared||||
1612656|NCT02516202|2960969|Superiority|||||||0.02||||||p-value calculation includes 195 participants with known responses at week 12.|Chi-squared||||
1612830|NCT02513940|2961099|Superiority|||||||0.6|||||||Mixed Models Analysis|Repeated measures ANOVA|||
1615068|NCT02473471|2964572|Other|||||||0.302|||||||t-test, 2 sided|||Day 1 after intervention|
1612657|NCT02516202|2960971|Superiority|||||||0.17||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures|||
1612658|NCT02516202|2960971|Superiority|||||||0.64||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures|||
1612659|NCT02516202|2960972|Superiority|||||||0.05||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures|||
1612660|NCT02516202|2960972|Superiority|||||||0.99||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures|||
1612661|NCT02516202|2960973|Superiority|||||||0.31||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures|||
1612662|NCT02516202|2960973|Superiority|||||||0.25||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|Regression, Linear|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures|||
1612663|NCT02516098|2960977|Superiority or Other||Geometric mean ratio (%): T/REF|92.96|||||2-Sided|92.46|81.94|105.47|||||ANOVA model was used with ‘sequence’, ‘treatment’ and ‘period’ as fixed effects and ‘subject within sequence’ as a random effect after logarithmic transformation of the data.|The test product was compared to the reference product by means of statistical analysis.|
1612664|NCT02516098|2960978|Superiority or Other||Geometric mean ratio (%): T/REF|91.66|||||2-Sided|92.46|83.59|100.51|||||ANOVA model was used with ‘sequence’, ‘treatment’ and ‘period’ as fixed effects and ‘subject within sequence’ as a random effect after logarithmic transformation of the data.|The test product was compared to the reference product by means of statistical analysis.|
1612665|NCT02516098|2960979|Non-Inferiority or Equivalence|Bioequivalence of the test and reference products for Stage 1 was assessed on the basis of the 92.46% confidence intervals for the geometric mean (test/reference) ratio for the AUC0-t in relation to the bioequivalence range of 80.00% to 125.00%, with a one-sided alpha of 0.0377.|Geometric mean ratio (%): T/REF|91.74|||||2-Sided|92.46|83.51|100.78|||||ANOVA model was used with ‘sequence’, ‘treatment’ and ‘period’ as fixed effects and ‘subject within sequence’ as a random effect after logarithmic transformation of the data.|The study design is a two-stage Pocock-like group sequential design according to the alpha spending function approach. The alpha level for Stage 1 was 0.0377 (one-sided).|
1612666|NCT02516098|2960980|Non-Inferiority or Equivalence|Bioequivalence of the test and reference product (for Stage 1) was assessed on the basis of the point estimate of the geometric mean ratio for Cmax in relation to the bioequivalence range of 80.00% to 125.00%.|Geometric mean ratio (%): T/REF|87.52|||||2-Sided|92.46|77.18|99.24|||||ANOVA model was used with ‘sequence’, ‘treatment’ and ‘period’ as fixed effects and ‘subject within sequence’ as a random effect after logarithmic transformation of the data.|The study design is a two-stage Pocock-like group sequential design according to the alpha spending function approach. The alpha level for Stage 1 was 0.0377 (one-sided).|
1612667|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.18||||0.6471|2-Sided|80.0|-2.85|5.21|||Mixed Models Analysis|||Change from baseline at Day 337|
1612668|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.71||||0.1965|2-Sided|80.0|-6.8|1.37|||Mixed Models Analysis|||Change from baseline at Day 337|
1612669|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.9||||0.1132|2-Sided|80.0|-8.03|0.23|||Mixed Models Analysis|||Change from baseline at Day 337|
1612670|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.94||||0.757|2-Sided|80.0|-1.64|5.53|||Mixed Models Analysis|||Change from baseline at Day 309|
1612831|NCT02513940|2961100|Superiority|||||||0.001||||||"Pairwise comparisons:~Testosterone vs placebo: p=0.008 Progesterone vs placebo: p=0.73 Testosterone vs progesterone: p=0.0008"|Mixed Models Analysis||||
1612832|NCT02513940|2961101|Superiority|||||||0.09|||||||Mixed Models Analysis||||
1615069|NCT02473471|2964572|Other|||||||0.1|||||||t-test, 2 sided|||12 hour after intervention|
1612671|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.7||||0.4027|2-Sided|80.0|-4.33|2.94|||Mixed Models Analysis|||Change from baseline at Day 309|
1612672|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.64||||0.1778|2-Sided|80.0|-6.31|1.03|||Mixed Models Analysis|||Change from baseline at Day 309|
1612673|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.94||||0.6335|2-Sided|80.0|-2.61|4.49|||Mixed Models Analysis|||Change from baseline at Day 281|
1612674|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.28||||0.2085|2-Sided|80.0|-5.88|1.33|||Mixed Models Analysis|||Change from baseline at Day 281|
1612675|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.22||||0.1283|2-Sided|80.0|-6.86|0.42|||Mixed Models Analysis|||Change from baseline at Day 281|
1612676|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|4.1||||0.956|2-Sided|80.0|1.03|7.17|||Mixed Models Analysis|||Change from baseline at Day 253|
1612677|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.46||||0.575|2-Sided|80.0|-2.67|3.59|||Mixed Models Analysis|||Change from baseline at Day 253|
1612678|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.64||||0.0708|2-Sided|80.0|-6.81|-0.47|||Mixed Models Analysis|||Change from baseline at Day 253|
1612679|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.46||||0.8163|2-Sided|80.0|-1.05|5.98|||Mixed Models Analysis|||Change from baseline at Day 225|
1612680|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.47||||0.2962|2-Sided|80.0|-5.0|2.06|||Mixed Models Analysis|||Change from baseline at Day 225|
1612681|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.93||||0.0798|2-Sided|80.0|-7.51|-0.35|||Mixed Models Analysis|||Change from baseline at Day 225|
1612682|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.36||||0.2867|2-Sided|80.0|-4.46|1.74|||Mixed Models Analysis|||Change from baseline at Day 197|
1612683|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.45||||0.1568|2-Sided|80.0|-5.57|0.67|||Mixed Models Analysis|||Change from baseline at Day 197|
1612684|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.09||||0.3285|2-Sided|80.0|-4.25|2.07|||Mixed Models Analysis|||Change from baseline at Day 197|
1612685|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.0||||0.4992|2-Sided|80.0|-2.82|2.81|||Mixed Models Analysis|||Change from baseline at Day 169|
1612686|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.05||||0.4909|2-Sided|80.0|-2.89|2.79|||Mixed Models Analysis|||Change from baseline at Day 169|
1612687|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.05||||0.4917|2-Sided|80.0|-2.92|2.82|||Mixed Models Analysis|||Change from baseline at Day 169|
1612688|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.47||||0.8977|2-Sided|80.0|-0.04|6.97|||Mixed Models Analysis|||Change from baseline at Day 141|
1612689|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.38||||0.4444|2-Sided|80.0|-3.89|3.13|||Mixed Models Analysis|||Change from baseline at Day 141|
1612690|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.85||||0.0838|2-Sided|80.0|-7.42|-0.28|||Mixed Models Analysis|||Change from baseline at Day 141|
1612691|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.76||||0.7644|2-Sided|80.0|-1.38|4.91|||Mixed Models Analysis|||Change from baseline at Day 113|
1612692|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.16||||0.1876|2-Sided|80.0|-5.29|0.97|||Mixed Models Analysis|||Change from baseline at Day 113|
1612693|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.92||||0.0575|2-Sided|80.0|-7.11|-0.74|||Mixed Models Analysis|||Change from baseline at Day 113|
1612694|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.5||||0.0475|2-Sided|80.0|-6.18|-0.82|||Mixed Models Analysis|||Change from baseline at Day 85|
1612695|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-3.37||||0.0534|2-Sided|80.0|-6.04|-0.7|||Mixed Models Analysis|||Change from baseline at Day 85|
1612696|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.13||||0.5247|2-Sided|80.0|-2.57|2.83|||Mixed Models Analysis|||Change from baseline at Day 85|
1612697|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.53||||0.411|2-Sided|80.0|-3.55|2.49|||Mixed Models Analysis|||Change from baseline at Day 57|
1612698|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.7||||0.236|2-Sided|80.0|-4.73|1.34|||Mixed Models Analysis|||Change from baseline at Day 57|
1612699|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.17||||0.3111|2-Sided|80.0|-4.22|1.88|||Mixed Models Analysis|||Change from baseline at Day 57|
1612700|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.22||||0.7256|2-Sided|80.0|-1.39|3.82|||Mixed Models Analysis|||Change from baseline at Day 29|
1612701|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.37||||0.8759|2-Sided|80.0|-0.26|5.01|||Mixed Models Analysis|||Change from baseline at Day 29|
1612702|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.16||||0.713|2-Sided|80.0|-1.49|3.8|||Mixed Models Analysis|||Change from baseline at Day 29|
1612703|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.46||||0.8861|2-Sided|80.0|-0.16|5.08|||Mixed Models Analysis|||Change from baseline at Day 2|
1612704|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.28||||0.4454|2-Sided|80.0|-2.89|2.33|||Mixed Models Analysis|||Change from baseline at Day 2|
1612705|NCT02515942|2960993|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.74||||0.0913|2-Sided|80.0|-5.38|-0.11|||Mixed Models Analysis|||Change from baseline at Day 2|
1612706|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.36||||0.5471|2-Sided|80.0|-4.24|3.53|||Mixed Models Analysis|||Change from baseline at Day 337|
1612707|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.2||||0.2353|2-Sided|80.0|-1.72|6.12|||Mixed Models Analysis|||Change from baseline at Day 337|
1612708|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.56||||0.2053|2-Sided|80.0|-1.44|6.55|||Mixed Models Analysis|||Change from baseline at Day 337|
1612709|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.4||||0.2126|2-Sided|80.0|-1.47|6.26|||Mixed Models Analysis|||Change from baseline at Day 309|
1612710|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.33||||0.2211|2-Sided|80.0|-1.57|6.23|||Mixed Models Analysis|||Change from baseline at Day 309|
1612711|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.07||||0.5086|2-Sided|80.0|-4.04|3.9|||Mixed Models Analysis|||Change from baseline at Day 309|
1612712|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.11||||0.3596|2-Sided|80.0|-2.87|5.09|||Mixed Models Analysis|||Change from baseline at Day 281|
1612713|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.41||||0.2194|2-Sided|80.0|-1.59|6.42|||Mixed Models Analysis|||Change from baseline at Day 281|
1612714|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.3||||0.3405|2-Sided|80.0|-2.78|5.38|||Mixed Models Analysis|||Change from baseline at Day 281|
1612715|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.03||||0.6504|2-Sided|80.0|-4.46|2.4|||Mixed Models Analysis|||Change from baseline at Day 253|
1612716|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.79||||0.2542|2-Sided|80.0|-1.69|5.27|||Mixed Models Analysis|||Change from baseline at Day 253|
1612717|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.82||||0.1537|2-Sided|80.0|-0.73|6.37|||Mixed Models Analysis|||Change from baseline at Day 253|
1612718|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.06||||0.5084|2-Sided|80.0|-3.74|3.62|||Mixed Models Analysis|||Change from baseline at Day 225|
1612719|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.72||||0.2741|2-Sided|80.0|-1.97|5.41|||Mixed Models Analysis|||Change from baseline at Day 225|
1612720|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.78||||0.2714|2-Sided|80.0|-1.99|5.55|||Mixed Models Analysis|||Change from baseline at Day 225|
1612721|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.65||||0.397|2-Sided|80.0|-2.54|3.84|||Mixed Models Analysis|||Change from baseline at Day 197|
1612722|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.93||||0.3535|2-Sided|80.0|-2.26|4.13|||Mixed Models Analysis|||Change from baseline at Day 197|
1612723|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.29||||0.4549|2-Sided|80.0|-2.97|3.55|||Mixed Models Analysis|||Change from baseline at Day 197|
1612724|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.25||||0.4557|2-Sided|80.0|-2.59|3.09|||Mixed Models Analysis|||Change from baseline at Day 169|
1612725|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.38||||0.7331|2-Sided|80.0|-4.25|1.48|||Mixed Models Analysis|||Change from baseline at Day 169|
1612726|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.63||||0.7643|2-Sided|80.0|-4.54|1.28|||Mixed Models Analysis|||Change from baseline at Day 169|
1612727|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.16||||0.5227|2-Sided|80.0|-3.67|3.36|||Mixed Models Analysis|||Change from baseline at Day 141|
1612728|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.33||||0.3127|2-Sided|80.0|-2.18|4.84|||Mixed Models Analysis|||Change from baseline at Day 141|
1612729|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.49||||0.2973|2-Sided|80.0|-2.11|5.08|||Mixed Models Analysis|||Change from baseline at Day 141|
1612730|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.77||||0.7844|2-Sided|80.0|-4.65|1.12|||Mixed Models Analysis|||Change from baseline at Day 113|
1612731|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.91||||0.1955|2-Sided|80.0|-0.95|4.77|||Mixed Models Analysis|||Change from baseline at Day 113|
1612732|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.68||||0.0544|2-Sided|80.0|0.75|6.61|||Mixed Models Analysis|||Change from baseline at Day 113|
1612733|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.04||||0.0762|2-Sided|80.0|0.32|5.76|||Mixed Models Analysis|||Change from baseline at Day 85|
1612734|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.95||||0.0316|2-Sided|80.0|1.24|6.66|||Mixed Models Analysis|||Change from baseline at Day 85|
1612735|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.91||||0.336|2-Sided|80.0|-1.85|3.66|||Mixed Models Analysis|||Change from baseline at Day 85|
1612736|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.71||||0.3727|2-Sided|80.0|-2.1|3.52|||Mixed Models Analysis|||Change from baseline at Day 57|
1612737|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.24||||0.286|2-Sided|80.0|-1.58|4.05|||Mixed Models Analysis|||Change from baseline at Day 57|
1612738|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.53||||0.4059|2-Sided|80.0|-2.32|3.37|||Mixed Models Analysis|||Change from baseline at Day 57|
1612739|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.48||||0.0875|2-Sided|80.0|0.14|4.82|||Mixed Models Analysis|||Change from baseline at Day 29|
1612740|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.4||||0.5862|2-Sided|80.0|-2.76|1.96|||Mixed Models Analysis|||Change from baseline at Day 29|
1612741|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.88||||0.9385|2-Sided|80.0|-5.26|-0.49|||Mixed Models Analysis|||Change from baseline at Day 29|
1612742|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.32||||0.4161|2-Sided|80.0|-1.6|2.24|||Mixed Models Analysis|||Change from baseline at Day 2|
1612743|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.46||||0.3771|2-Sided|80.0|-1.44|2.37|||Mixed Models Analysis|||Change from baseline at Day 2|
1612744|NCT02515942|2960994|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.15||||0.4609|2-Sided|80.0|-1.79|2.09|||Mixed Models Analysis|||Change from baseline at Day 2|
1612745|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.37||||0.5451|2-Sided|80.0|-4.62|3.87|||Mixed Models Analysis|||Change from baseline at Day 337|
1612746|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.2||||0.5237|2-Sided|80.0|-4.54|4.14|||Mixed Models Analysis|||Change from baseline at Day 337|
1612747|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.17||||0.4799|2-Sided|80.0|-4.23|4.57|||Mixed Models Analysis|||Change from baseline at Day 337|
1612748|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.68||||0.0907|2-Sided|80.0|0.15|7.21|||Mixed Models Analysis|||Change from baseline at Day 309|
1612749|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.14||||0.2227|2-Sided|80.0|-1.46|5.74|||Mixed Models Analysis|||Change from baseline at Day 309|
1612750|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.54||||0.7063|2-Sided|80.0|-5.19|2.11|||Mixed Models Analysis|||Change from baseline at Day 309|
1612751|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.41||||0.3083|2-Sided|80.0|-2.21|5.02|||Mixed Models Analysis|||Change from baseline at Day 281|
1612752|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.85||||0.3833|2-Sided|80.0|-2.84|4.55|||Mixed Models Analysis|||Change from baseline at Day 281|
1612753|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.56||||0.5758|2-Sided|80.0|-4.29|3.18|||Mixed Models Analysis|||Change from baseline at Day 281|
1612754|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.85||||0.1457|2-Sided|80.0|-0.62|6.32|||Mixed Models Analysis|||Change from baseline at Day 253|
1612755|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.3||||0.2018|2-Sided|80.0|-1.24|5.85|||Mixed Models Analysis|||Change from baseline at Day 253|
1612756|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.55||||0.5778|2-Sided|80.0|-4.14|3.04|||Mixed Models Analysis|||Change from baseline at Day 253|
1612757|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.46||||0.285|2-Sided|80.0|-1.85|4.77|||Mixed Models Analysis|||Change from baseline at Day 225|
1612758|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.11||||0.3358|2-Sided|80.0|-2.25|4.46|||Mixed Models Analysis|||Change from baseline at Day 225|
1612759|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.35||||0.5533|2-Sided|80.0|-3.76|3.05|||Mixed Models Analysis|||Change from baseline at Day 225|
1612760|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.95||||0.6548|2-Sided|80.0|-4.0|2.11|||Mixed Models Analysis|||Change from baseline at Day 197|
1612761|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.25||||0.6973|2-Sided|80.0|-4.35|1.85|||Mixed Models Analysis|||Change from baseline at Day 197|
1612762|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.3||||0.5487|2-Sided|80.0|-3.44|2.84|||Mixed Models Analysis|||Change from baseline at Day 197|
1612763|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.04||||0.507|2-Sided|80.0|-2.72|2.64|||Mixed Models Analysis|||Change from baseline at Day 169|
1612764|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.99||||0.679|2-Sided|80.0|-3.71|1.74|||Mixed Models Analysis|||Change from baseline at Day 169|
1612765|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.95||||0.6708|2-Sided|80.0|-3.71|1.81|||Mixed Models Analysis|||Change from baseline at Day 169|
1612766|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.92||||0.0773|2-Sided|80.0|0.29|5.55|||Mixed Models Analysis|||Change from baseline at Day 141|
1612767|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.98||||0.3179|2-Sided|80.0|-1.68|3.64|||Mixed Models Analysis|||Change from baseline at Day 141|
1612768|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.94||||0.8221|2-Sided|80.0|-4.64|0.76|||Mixed Models Analysis|||Change from baseline at Day 141|
1612769|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.2||||0.4625|2-Sided|80.0|-2.53|2.93|||Mixed Models Analysis|||Change from baseline at Day 113|
1612770|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.3||||0.5564|2-Sided|80.0|-3.05|2.45|||Mixed Models Analysis|||Change from baseline at Day 113|
1612771|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.5||||0.5916|2-Sided|80.0|-3.3|2.29|||Mixed Models Analysis|||Change from baseline at Day 113|
1612772|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.48||||0.5976|2-Sided|80.0|-2.99|2.03|||Mixed Models Analysis|||Change from baseline at Day 85|
1612773|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.81||||0.3402|2-Sided|80.0|-1.72|3.34|||Mixed Models Analysis|||Change from baseline at Day 85|
1612774|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.29||||0.2582|2-Sided|80.0|-1.27|3.85|||Mixed Models Analysis|||Change from baseline at Day 85|
1612775|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.44||||0.4149|2-Sided|80.0|-2.18|3.06|||Mixed Models Analysis|||Change from baseline at Day 57|
1612776|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.61||||0.616|2-Sided|80.0|-3.26|2.04|||Mixed Models Analysis|||Change from baseline at Day 57|
1612777|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.04||||0.6924|2-Sided|80.0|-3.72|1.63|||Mixed Models Analysis|||Change from baseline at Day 57|
1612778|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.24||||0.4431|2-Sided|80.0|-1.94|2.42|||Mixed Models Analysis|||Change from baseline at Day 30|
1612779|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.38||||0.4125|2-Sided|80.0|-1.84|2.6|||Mixed Models Analysis|||Change from baseline at Day 30|
1612780|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.14||||0.4682|2-Sided|80.0|-2.11|2.39|||Mixed Models Analysis|||Change from baseline at Day 30|
1612781|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|4.03||||0.015|2-Sided|80.0|1.67|6.4|||Mixed Models Analysis|||Change from baseline at Day 29|
1612782|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|2.03||||0.1402|2-Sided|80.0|-0.38|4.44|||Mixed Models Analysis|||Change from baseline at Day 29|
1612783|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment|-2.01||||0.8544|2-Sided|80.0|-4.45|0.43|||Mixed Models Analysis|||Change from baseline at Day 29|
1612784|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.81||||0.1685|2-Sided|80.0|-0.61|4.24|||Mixed Models Analysis|||Change from baseline at Day 15|
1612785|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effecgt|-0.12||||0.5255|2-Sided|80.0|-2.59|2.35|||Mixed Models Analysis|||Change from baseline at Day 15|
1612786|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-1.94||||0.8392|2-Sided|80.0|-4.44|0.57|||Mixed Models Analysis|||Change from baseline at Day 15|
1612787|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.61||||0.2058|2-Sided|80.0|-0.91|4.12|||Mixed Models Analysis|||Change from baseline at Day 8|
1612788|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|1.29||||0.2575|2-Sided|80.0|-1.25|3.83|||Mixed Models Analysis|||Change from baseline at Day 8|
1612789|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.32||||0.5632|2-Sided|80.0|-2.91|2.27|||Mixed Models Analysis|||Change from baseline at Day 8|
1612790|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|3.23||||0.0418|2-Sided|80.0|0.85|5.61|||Mixed Models Analysis|||Change from baseline at Day 2|
1612791|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.51||||0.3929|2-Sided|80.0|-1.89|2.91|||Mixed Models Analysis|||Change from baseline at Day 2|
1612792|NCT02515942|2960995|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-2.72||||0.9243|2-Sided|80.0|-5.15|-0.29|||Mixed Models Analysis|||Change from baseline at Day 2|
1612793|NCT02515942|2960997|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.08||||0.7087|2-Sided|80.0|-0.11|0.27|||Mixed Models Analysis|||Change from baseline at Day 253|
1612794|NCT02515942|2960997|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.17||||0.1386|2-Sided|80.0|-0.37|0.03|||Mixed Models Analysis|||Change from baseline at Day 253|
1612795|NCT02515942|2960997|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.25||||0.053|2-Sided|80.0|-0.45|-0.05|||Mixed Models Analysis|||Change from baseline at Day 253|
1612796|NCT02515942|2960997|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.01||||0.4717|2-Sided|80.0|-0.16|0.14|||Mixed Models Analysis|||Change from baseline at Day 169|
1612797|NCT02515942|2960997|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.13||||0.1398|2-Sided|80.0|-0.29|0.02|||Mixed Models Analysis|||Change from baseline at Day 169|
1612798|NCT02515942|2960997|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|-0.12||||0.1545|2-Sided|80.0|-0.28|0.03|||Mixed Models Analysis|||Change from baseline at Day 169|
1612799|NCT02515942|2960997|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.04||||0.6826|2-Sided|80.0|-0.07|0.14|||Mixed Models Analysis|||Change from baseline at Day 85|
1612800|NCT02515942|2960997|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.04||||0.682|2-Sided|80.0|-0.07|0.14|||Mixed Models Analysis|||Change from baseline at Day 85|
1612801|NCT02515942|2960997|Superiority|Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject.|Treatment Effect|0.0||||0.5029|2-Sided|80.0|-0.11|0.11|||Mixed Models Analysis|||Change from baseline at Day 85|
1612802|NCT02515942|2960998|Superiority||Treatment Effect|0.06||||0.5987|2-Sided|80.0|-0.24|0.35|||ANCOVA|||Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.|
1612803|NCT02515942|2960998|Superiority||Treatment Effect|-0.29||||0.1019|2-Sided|80.0|-0.59|0.0|||ANCOVA|||Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.|
1612804|NCT02515942|2960998|Superiority|Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations.|Treatment Effect|-0.35||||0.0636|2-Sided|80.0|-0.64|-0.06|||ANCOVA||||
1612805|NCT02515331|2961032|Superiority||Mean Difference (Net)|-14.727|Standard Error of the Mean|3.0548|<|0.001|2-Sided|95.0|-20.852|-8.602||1-sided p-value|Longitudinal repeated measures mixed eff||||
1612806|NCT02515331|2961032|Superiority||Mean Difference (Net)|-8.555|Standard Error of the Mean|2.9077|<|0.002|2-Sided|95.0|-14.388|-2.722||1-sided p-value|Longitudinal repeated measures mixed eff||||
1612807|NCT02514889|2961046|Equivalence|For the comparison conditions to be judged equivalent, as predicted, the critical p-value was set to P >.20|Mean Difference (Net)|0.14|Standard Error of the Mean|0.51||0.776|2-Sided|95.0|-0.85|1.14|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)||
1612808|NCT02514889|2961047|Equivalence|For the comparison conditions to be equivalent, as predicted, the critical alpha was set at P > 0.20.|Mean Difference (Net)|-0.04|Standard Error of the Mean|0.135||0.747|2-Sided|95.0|-0.31|0.22|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)||
1612809|NCT02514889|2961048|Superiority||Mean Difference (Net)|0.46|Standard Error of the Mean|0.99||0.64|2-Sided|95.0|-1.47|2.39|||Mixed Models Analysis||The differences in difference interaction term consists of the product of assessment intervals (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)||
1612810|NCT02514889|2961049|Superiority|Difference in differences|Mean Difference (Net)|-1.88|Standard Error of the Mean|2.35||0.3|2-Sided|95.0|-6.47|2.74|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment, marital status|The difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting)||
1612811|NCT02514889|2961050|Superiority||Mean Difference (Net)|-1.37|Standard Error of the Mean|2.55||0.504|2-Sided|95.0|-6.37|3.63|||Mixed Models Analysis|Covariates included: age, sex, ethnicity, educational attainment and marital status|Difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting).||
1612812|NCT02514889|2961051|Equivalence|p-value >0.20 would be considered equivalent.|Mean Difference (Final Values)|2.59|Standard Error of the Mean|1.39||0.06|2-Sided|95.0|-0.1342|5.3228|||Mixed Models Analysis|Covariates included age, sex, ethnicity, educational attainment and marital status|||
1612813|NCT02514889|2961052|Superiority||Mean Difference (Final Values)|-2.11|Standard Error of the Mean|2.05||0.3|2-Sided|95.0|-6.12|1.91||a priori threshold is p = .017, so that experiment-wide critical alpha would be p = .05.|Mixed Models Analysis|Covariates: sex, age, ethnicity, marital status and educational attainment|Difference in differences interaction term is the product of assessment period (baseline, 6-months, 12-months) and experimental condition (MyPlate, Calorie Counting).||
1612814|NCT02514772|2961053|Other||Mean Difference (Final Values)|-7.2|||||2-Sided|95.0|-26.0|11.4||||||Incidence difference of infusion-related reactions overall on day(s) of or day(s) after either infusion (i.e. on day 1 or 2 and on day 14 or day 15).|
1612815|NCT02514772|2961053|Other||Mean Difference (Final Values)|-5.3|||||2-Sided|95.0|-24.5|13.6||||||Incidence difference of infusion-related reactions, occurred on day of or on day after second infusion (i.e. on study day 14 or on study day 15).|
1612816|NCT02514772|2961053|Other||Mean Difference (Final Values)|-5.4|||||2-Sided|95.0|-24.2|13.3||||||Incidence difference of infusion-related reactions, occurred on day of or on day after first infusion (i.e. on study day 1 or on study day 2).|
1612817|NCT02514772|2961054|Other||Difference (%)|-1.9|||||2-Sided|95.0|-21.2|17.6|||||||
1612818|NCT02514772|2961055|Other||Difference (%)|-1.7|||||2-Sided|95.0|-20.6|16.9|||||||
1612819|NCT02514772|2961056|Other||Difference (%)|-1.9|||||2-Sided|95.0|-20.6|16.9|||||||
1612820|NCT02514551|2961063|Superiority||Hazard Ratio (HR)|0.963|||||2-Sided|95.0|0.727|1.274|||||Unstratified cox proportional hazards model.||
1612821|NCT02514551|2961064|Superiority||Hazard Ratio (HR)|0.617|||||2-Sided|95.0|0.447|0.853|||||Unstratified cox proportional hazards model comparing Ramucirumab I4T-MC-JVCZ and I4T-IE-JVBE (NCT01170663)|"This analysis were comparison of PFS for participants treated with ramucirumab 12 mg/kg plus paclitaxel in Study I4T-MC-JVCZ versus placebo plus paclitaxel in I4T-IE-JVBE (NCT01170663) using meta-analysis.~Placebo + 80 mg/m² Paclitaxel in I4T-IE-JVBE Number of participants: 335, Median (95% CI), months: 2.86 (2.79 to 3.02)"|
1612822|NCT02514473|2961083|Superiority||Least Square (LS) Mean Difference|-1.09|||<|0.0001|2-Sided|95.0|-1.43|-0.75|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM). The model included treatment, visit and treatment-by-visit interaction as fixed effects; and participant as a random effect with adjustments for baseline, weight (less than [<] 25 kilogram [kg] versus greater than or equal to [>=] 25 kg) and percent predicted forced expiratory volume in 1 second (FEV1) severity (<90 versus >=90) at screening.|
1612823|NCT02514122|2961090|Superiority||Risk Difference (RD)|0.37|||<|0.001|2-Sided|95.0|0.18|0.54|||Fisher Exact||||
1612824|NCT02514122|2961091|Superiority||Mean Difference (Final Values)|0.83||||0.009|2-Sided|95.0|0.29|1.9||The p-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05.|t-test, 2 sided||Score was lower in the Ketamine group.||
1612825|NCT02514044|2961095|Other|We also performed normalization by calculating the dependent variable as the percentage of change (“proportional change”) as it follows; (1) (post-active values – pre-active values)/ (pre-active values) and (2) (post-placebo values – pre-placebo values)/ (pre-placebo series). We compared the percentage of change in Bedside WAB-R® aphasia and language quotients and blood pressures for the experiments with active- and placebo drugs combined active tDCS with MIT using a two-tailed paired t-test.||||||0.02|||||||t-test, 2 sided|||We tested normality using the Kolmogorov–Smirnov (KS) test for all reported measures. We compared scores of Bedside WAB-R® subtests Bedside WAB-R® AQ and LQ from before the study intervention and after the intervention in both experiments by using a two-tailed and paired t-test.|
1612826|NCT02514044|2961096|Other|"We also performed normalization by calculating the dependent variable as the percentage of change (proportional change) as it follows; (1) (post-active values - pre-active values)/ (pre-active values) and (2) (post-placebo values - pre-placebo values)/ (pre-placebo series). We compared the percentage of change in Bedside WAB-R® aphasia and language quotients and blood pressures for the experiments with active- and placebo drugs combined active tDCS with MIT using a two-tailed paired t-test."||||||0.008|||||||t-test, 2 sided|||We tested normality using the Kolmogorov-Smirnov (KS) test for all reported measures. We compared scores of Bedside WAB-R® subtests Bedside WAB-R® AQ and LQ from before the study intervention and after the intervention in both experiments by using a two-tailed and paired t-test.|
1612827|NCT02513940|2961097|Superiority||||||>|0.99|||||||Fisher Exact|||Rash at gel application site|
1612828|NCT02513940|2961097|Superiority||||||>|0.99|||||||Fisher Exact|||Fatigue|
1612829|NCT02513940|2961098|Superiority|||||||0.0003||||||"Pairwise comparisons:~Testosterone vs placebo: p = 0.0001 Progesterone vs placebo: p = 0.25 Testosterone vs progesterone: p = 0.002"|Mixed Models Analysis|Repeated measures ANOVA|||
1612833|NCT02513771|2961119|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)|Stratified Wilcoxon rank-sum test stratified by screening CD4 count (<= or > 350 cells/mm^3) and statin use.||Null hypothesis: There is no difference between the two arms in the change in sCD14 from baseline to week 15/16.|
1612834|NCT02513550|2961370|Superiority||Risk Difference (RD)|4.6|||=|0|2-Sided||||||Regression, Logistic||||
1612835|NCT02513550|2961370|Superiority||Risk Difference (RD)|6.9|||=|0|2-Sided||||||Regression, Logistic||||
1612836|NCT02513550|2961371|Superiority||Risk Difference (RD)|1.9|||=|0|2-Sided||||||Regression, Logistic||||
1612837|NCT02513550|2961371|Superiority||Risk Difference (RD)|7.9|||=|0|2-Sided||||||Regression, Logistic||||
1612838|NCT02513446|2961412|Superiority or Other||Adjusted gMean T/R ratio|174.8|||||2-Sided|90.0|159.1|192.0|||||Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).||
1612839|NCT02513446|2961413|Superiority or Other||Adjusted gMean T/R ratio|136.5|||||2-Sided|90.0|109.9|169.4|||||Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).||
1612840|NCT02513446|2961414|Superiority or Other||Adjusted gMean T/R ratio|176.1|||||2-Sided|90.0|160.5|193.2|||||Ratio of the treatment adjusted geometric means (gMean) of (T) versus (R).||
1612841|NCT02513160|2961416|Superiority or Other|||||||0.0062|||||||Log Rank||||
1612842|NCT02513160|2961416|Superiority or Other|||||||0.0014|||||||Log Rank||||
1612843|NCT02513160|2961416|Superiority or Other|||||||0.0058|||||||Log Rank||||
1612844|NCT02513160|2961417|Superiority or Other||LSM difference|-0.3|||<|0.0001|2-Sided|95.0|-0.423|-0.185||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.|
1612845|NCT02513160|2961417|Superiority or Other||LSM difference|-0.25|||<|0.0001|2-Sided|95.0|-0.365|-0.128||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.|
1612846|NCT02513160|2961417|Superiority or Other||LSM difference|-0.32|||<|0.0001|2-Sided|95.0|-0.44|-0.203||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.|
1612847|NCT02513160|2961418|Superiority or Other||LSM difference|-1.03|||<|0.0001|2-Sided|95.0|-1.415|-0.643||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.|
1612848|NCT02513160|2961418|Superiority or Other||LSM difference|-1.1|||<|0.0001|2-Sided|95.0|-1.482|-0.717||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.|
1612849|NCT02513160|2961418|Superiority or Other||LSM difference|-1.02|||<|0.0001|2-Sided|95.0|-1.408|-0.64||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.|
1612850|NCT02513160|2961419|Superiority or Other||LSM difference|133.0||||0.0003|2-Sided|95.0|61.3|204.3||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.|
1612851|NCT02513160|2961419|Superiority or Other||LSM difference|170.0|||<|0.0001|2-Sided|95.0|98.5|240.5||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.|
1612852|NCT02513160|2961419|Superiority or Other||LSM difference|143.0|||<|0.0001|2-Sided|95.0|71.7|214.1||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in Outcome #2, analysis #1.|
1612853|NCT02513160|2961420|Superiority or Other||LSM difference|21.0||||0.0006|2-Sided|95.0|9.14|32.83||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Comparisons for MDI dose versus placebo for the secondary efficacy endpoints were used for assay sensitivity.|
1612854|NCT02513160|2961420|Superiority or Other||LSM difference|30.1|||<|0.0001|2-Sided|95.0|18.33|41.9||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Sequential order of analyses described in previous analysis.|
1612855|NCT02513160|2961420|Superiority or Other||LSM difference|21.9|||<|0.0003|2-Sided|95.0|10.11|33.71||a priori threshold for significance of 0.05.|mixed model for repeated measures|MMRM analysis with covariates for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Active - placebo|Treatment comparisons began with am PEF for BAI 640 mcg/day vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BAI 640 mcg/day vs placebo 2) the am PEF for BAI 320 mcg/day vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.|
1612897|NCT02512276|2961552|Superiority||Mean Difference (Net)|4.7|||||2-Sided|95.0|3.0|6.4|||||||
1614113|NCT02503202|2962189|Other||Risk Difference (RD)|-5.7|||<|0.1|2-Sided|95.0|-12.5|1.1|||Miettinen & Nurminen||Risk difference is Lot B - Lot C||
1612856|NCT02513160|2961421|Superiority or Other||LSM difference|148.0|||<|0.0001|2-Sided|95.0|84.7|211.4||a priori threshold for significance of 0.05. The p-value was not adjusted.|ANCOVA|Difference of LS means and 95% CI represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo||
1612857|NCT02513160|2961421|Superiority or Other||LSM difference|144.0|||<|0.0001|2-Sided|95.0|80.7|206.6||a priori threshold for significance of 0.05.|ANCOVA|Difference of LS means, 95% CI, and p-value represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|A fixed-sequence multiple testing procedure was implemented to interpret the results from the primary analysis while controlling the family-wise error rate at 5%. The 640-mcg/day BAI dose was tested first. If the comparison to placebo resulted in p≤0.05, the 320-mcg/day BAI dose was then tested.|
1612858|NCT02513160|2961421|Superiority or Other||LSM difference|150.0|||<|0.0001|2-Sided|95.0|86.8|213.2||a priori threshold for significance of 0.05.|ANCOVA|Difference of LS means, 95% CI, and p-value represent ANCOVA results adjusted for baseline, sex, age, current asthma therapy, and treatment.|Active - placebo|A fixed-sequence multiple testing procedure was implemented to interpret the results from the primary analysis while controlling the family-wise error rate at 5%. The 640-mcg/day BAI dose was tested first. If the comparison to placebo resulted in p≤0.05, the 320-mcg/day BAI dose was then tested.|
1612859|NCT02512874|2961453|Superiority|||||||0.62|||||||Chi-squared||||
1612860|NCT02512575|2961469|Superiority or Other||Ratio (Active Vs Placebo)|0.691||||||90.0|0.608|0.785|||||||
1612861|NCT02512575|2961469|Superiority or Other||Ratio (Active Vs Placebo)|0.893|||||2-Sided|90.0|0.784|1.02|||||||
1612862|NCT02512575|2961469|Superiority or Other||Ratio (Active Vs Placebo)|0.907|||||2-Sided|90.0|0.798|1.03|||||||
1612863|NCT02512575|2961469|Superiority or Other||Ratio (Active Vs Placebo)|0.927|||||2-Sided|90.0|0.815|1.05|||||||
1612864|NCT02512575|2961469|Superiority or Other||Ratio (Active Vs Placebo)|0.848|||||2-Sided|90.0|0.745|0.964|||||||
1612865|NCT02512575|2961469|Superiority or Other||Ratio (Active Vs Placebo)|0.861|||||2-Sided|90.0|0.757|0.979|||||||
1612866|NCT02512575|2961469|Superiority or Other||Ratio (Active Vs Placebo)|0.942|||||2-Sided|90.0|0.829|1.07|||||||
1612867|NCT02512575|2961469|Superiority or Other||Ratio (Active Vs Placebo)|0.961||||||90.0|0.846|1.09|||||||
1612868|NCT02512575|2961469|Superiority or Other||Ratio (Active Vs Placebo)|0.982|||||2-Sided|90.0|0.861|1.12|||||||
1612869|NCT02512575|2961470|Superiority or Other||Ratio (Active Vs Placebo)|0.687|||||2-Sided|90.0|0.572|0.825|||||||
1612870|NCT02512575|2961470|Superiority or Other||Ratio (Active Vs Placebo)|1.02|||||2-Sided|90.0|0.846|1.22|||||||
1612871|NCT02512575|2961470|Superiority or Other||Ratio (Active Vs Placebo)|1.01|||||2-Sided|90.0|0.842|1.21|||||||
1612872|NCT02512575|2961470|Superiority or Other||Ratio (Active Vs Placebo)|0.86|||||2-Sided|90.0|0.716|1.03|||||||
1612873|NCT02512575|2961470|Superiority or Other||Ratio (Active Vs Placebo)|0.876|||||2-Sided|90.0|0.728|1.05|||||||
1612874|NCT02512575|2961470|Superiority or Other||Ratio (Active Vs Placebo)|0.914|||||2-Sided|90.0|0.762|1.1|||||||
1612875|NCT02512575|2961470|Superiority or Other||Ratio (Active Vs Placebo)|0.907|||||2-Sided|90.0|0.745|1.1|||||||
1612876|NCT02512575|2961470|Superiority or Other||Ratio (Active Vs Placebo)|1.05|||||2-Sided|90.0|0.874|1.26|||||||
1612877|NCT02512575|2961470|Superiority or Other||Ratio (Active Vs Placebo)|1.05|||||2-Sided|90.0|0.872|1.26|||||||
1612878|NCT02512575|2961471|Superiority or Other||Ratio (Active Vs Placebo)|1.19|||||2-Sided|90.0|1.11|1.27|||||||
1612879|NCT02512575|2961471|Superiority or Other||Ratio (Active Vs Placebo)|1.2|||||2-Sided|90.0|1.11|1.29|||||||
1612880|NCT02512575|2961471|Superiority or Other||Ratio (Active Vs Placebo)|1.15|||||2-Sided|90.0|1.07|1.24|||||||
1612881|NCT02512575|2961471|Superiority or Other||Ratio (Active Vs Placebo)|1.17|||||2-Sided|90.0|1.09|1.25|||||||
1612882|NCT02512575|2961471|Superiority or Other||Ratio (Active Vs Placebo)|1.07|||||2-Sided|90.0|0.995|1.15|||||||
1612883|NCT02512575|2961471|Superiority or Other||Ratio (Active Vs Placebo)|1.06|||||2-Sided|95.0|0.983|1.13|||||||
1612884|NCT02512575|2961471|Superiority or Other||Ratio (Active Vs Placebo)|1.06|||||2-Sided|90.0|0.987|1.14|||||||
1612885|NCT02512575|2961471|Superiority or Other||Ratio (Active Vs Placebo)|1.0|||||2-Sided|90.0|0.929|1.08|||||||
1612886|NCT02512575|2961471|Superiority or Other||Ratio (Active Vs Placebo)|1.03|||||2-Sided|90.0|0.96|1.11|||||||
1612887|NCT02512575|2961472|Superiority or Other||Slope|0.917|Standard Error of the Mean|0.0364|||2-Sided|90.0|0.856|0.978|||||||
1612888|NCT02512575|2961473|Superiority or Other||Slope|0.93|Standard Error of the Mean|0.0364|||2-Sided|90.0|0.869|0.991|||||||
1612889|NCT02512575|2961476|Superiority or Other||Slope|0.847|Standard Error of the Mean|0.0238|||2-Sided|90.0|0.807|0.887|||||||
1612890|NCT02512419|2961484|Superiority||Median Difference (Final Values)|42.36|Standard Error of the Mean|38.83||0.1|2-Sided||||||quantile regression|||Quantile regression was used.|
1612891|NCT02512419|2961485|Superiority||regression parameter (median diff)|37.52|Standard Error of the Mean|18.01||0.04|2-Sided||||||quantile regression|Models regressed outcome at 6 months on treatment assigned, baseline value of the outcome and actigraph wear time. Effect sizes reported are adjusted|Effects are unstandardized regression coefficients. They represent difference in median outcome between conditions at 6m controlling for baseline and covariates.|To examine potential intervention effects on the primary outcome (MVPA at 6 months), we used a series of quantile regression models which model median outcome at follow-up as a function of baseline value of the outcome (MVPA), treatment condition and covariates. Note that the adjusted difference in median MVPA between conditions at follow-up will not equal the difference in median minutes as seen in the unadjusted tables as these estimates are adjusted|
1612892|NCT02512276|2961547|Superiority||Odds Ratio (OR)|1.02|||||2-Sided|95.0|0.78|1.34|||||||
1612893|NCT02512276|2961548|Superiority||Odds Ratio (OR)|1.11|||||2-Sided|95.0|0.91|1.36|||||||
1612894|NCT02512276|2961549|Superiority||Odds Ratio (OR)|0.62|||||2-Sided|95.0|0.45|0.85|||||||
1612895|NCT02512276|2961550|Superiority||Odds Ratio (OR)|1.1|||||2-Sided|95.0|0.94|1.28|||||||
1612896|NCT02512276|2961551|Superiority||Odds Ratio (OR)|1.05|||||2-Sided|95.0|0.91|1.22|||||||
1612898|NCT02512068|2961563|Other||Point estimate|-2.66|||||2-Sided|95.0|-3.608|-1.715||||||Change from baseline in glycoalbumin at End of Treatment Period I was compared between the treatment groups.|
1612899|NCT02512068|2961563|Other||Point estimate|-2.66|||||2-Sided|95.0|-3.608|-1.715||||||Change from baseline in glycoalbumin at Week 12 was compared between the treatment groups.|
1612900|NCT02512068|2961563|Other||Point estimate|-2.48|||||2-Sided|95.0|-3.289|-1.679||||||Change from baseline in glycoalbumin at Week 8 was compared between the treatment groups.|
1612901|NCT02512068|2961563|Other||Point estimate|-2.45||||||95.0|-3.03|-1.87||||||Change from baseline in glycoalbumin at Week 4 was compared between the treatment groups.|
1612902|NCT02512068|2961563|Other||Point estimate|-1.76|||||2-Sided|95.0|-2.184|-1.34||||||Change from baseline in glycoalbumin at Week 2 was compared between the treatment groups.|
1612903|NCT02512068|2961564|Other||Point estimate|-15.6|||||2-Sided|95.0|-26.67|-4.62||||||Change from baseline in fasting plasma glucose at End of Treatment Period I was compared between the treatment groups.|
1612904|NCT02512068|2961564|Other||Point estimate|-15.6|||||2-Sided|95.0|-27.14|-4.03||||||Change from baseline in fasting plasma glucose at Week 12 was compared between the treatment groups.|
1612905|NCT02512068|2961564|Other||Point estimate|-8.3|||||2-Sided|95.0|-18.76|2.11||||||Change from baseline in fasting plasma glucose at Week 8 was compared between the treatment groups.|
1612906|NCT02512068|2961564|Other||Point estimate|-8.7|||||2-Sided|95.0|-20.98|3.58||||||Change from baseline in fasting plasma glucose at Week 4 was compared between the treatment groups.|
1612907|NCT02512068|2961564|Other||Point estimate|-15.2|||||2-Sided|95.0|-23.59|-6.88||||||Change from baseline in fasting plasma glucose at Week 2 was compared between the treatment groups.|
1612908|NCT02512068|2961565|Other||Point estimate|45.6|||||2-Sided|95.0|15.528|75.7||||||The data of participants achieving <8.0% at the end of Treatment Period I were compared between the treatment groups.|
1612909|NCT02512068|2961565|Other||Point estimate|32.9|||||2-Sided|95.0|14.194|51.66||||||The data of participants achieving <7.0% at the end of Treatment Period I were compared between the treatment groups.|
1612910|NCT02512068|2961565|Other||Point estimate|1.7|||||2-Sided|95.0|-6.598|9.919||||||The data of participants achieving <6.0% at the end of Treatment Period I were compared between the treatment groups.|
1612911|NCT02512068|2961566|Other||Point estimate|-0.7|||||2-Sided|95.0|-0.948|-0.452||||||Change from baseline in HbA1c at End of Treatment Period I was compared between the treatment groups.|
1612912|NCT02512068|2961566|Other||Point estimate|-0.71|||||2-Sided|95.0|-0.975|-0.441||||||Change from baseline in HbA1c at Week 12 was compared between the treatment groups.|
1612913|NCT02512068|2961566|Other||Point estimate|-0.58|||||2-Sided|95.0|-0.797|-0.367||||||Change from baseline in HbA1c at Week 8 was compared between the treatment groups.|
1612914|NCT02512068|2961566|Other||Point estimate|-0.48|||||2-Sided|95.0|-0.621|-0.338||||||Change from baseline in HbA1c at Week 4 was compared between the treatment groups.|
1612915|NCT02512068|2961566|Other||Point estimate|-0.28|||||2-Sided|95.0|-0.385|-0.18||||||Change from baseline in HbA1c at Week 2 was compared between the treatment groups.|
1612916|NCT02512068|2961569|Superiority||Least square (LS) mean difference|-0.72|Standard Error of the Mean|0.124|<|0.0001|2-Sided|95.0|-0.966|-0.473|||ANCOVA||||
1612917|NCT02512042|2961570|Equivalence|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 10:00 hour on Day 42 should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population|Mean Difference (Net)|-0.19|||||2-Sided|95.0|-0.5|0.13|||||||
1612918|NCT02512042|2961570|Equivalence|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 10:00 hour on Day 14 should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.4|||||2-Sided|95.0|-0.71|-0.09|||||||
1612919|NCT02512042|2961570|Equivalence|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 8:00 hour on Day 42 should be within +/-1.5mm Hg, and should be within +/- 1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.11|||||2-Sided|95.0|-0.43|0.22|||||||
1612920|NCT02512042|2961570|Equivalence|The limits of each two-sided 95% confidence interval of the treatment difference (test-reference) for mean IOP of both eyes at approximately 8:00 (hours 0, before the morning drop) at the Day 14 visit should be within +/-1.5mm Hg, and should be within +/-1.0mm Hg for majority of time points using the PP population.|Mean Difference (Net)|-0.36|||||2-Sided|95.0|-0.69|-0.03|||||||
1612921|NCT02511782|2961571|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1612922|NCT02511782|2961572|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1612923|NCT02511678|2961587|Superiority|||||||0.0746||||||The 1-sided p-value was based on a t-test against a performance goal of -2.|t-test, 1 sided||||
1612924|NCT02510144|2961666|Superiority||||||<|0.01|||||||t-test, 2 sided|||Negative cultures were compared on the treated side versus the non-treated side|
1612925|NCT02510144|2961666|Superiority||||||<|0.68|||||||t-test, 2 sided|||Negative cultures were compared on the treated side vs the non-treated side|
1612926|NCT02509117|2961717|Superiority or Other||Adjusted Mean Difference|-61.797|Standard Error of the Mean|0.1014|<|0.0001|2-Sided|80.0|-66.51|-56.42|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.|
1612927|NCT02509117|2961717|Superiority or Other||Adjusted Mean Difference|-45.018|Standard Error of the Mean|0.1001|<|0.0001|2-Sided|80.0|-51.72|-37.38|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.|
1612928|NCT02509117|2961717|Superiority or Other||Adjusted Mean Difference|-37.373|Standard Error of the Mean|0.1007|<|0.0001|2-Sided|80.0|-45.06|-28.62|||Mixed Model Repeated Measures|||ABeta Total: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.|
1612929|NCT02509117|2961717|Superiority or Other||Adjusted Mean Difference|-59.583|Standard Error of the Mean|0.0558|<|0.0001|2-Sided|80.0|-62.4|-56.56|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.|
1612974|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||Physical functioning domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612930|NCT02509117|2961717|Superiority or Other||Adjusted Mean Difference|-51.368|Standard Error of the Mean|0.0561|<|0.0001|2-Sided|80.0|-54.78|-47.7|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.|
1612931|NCT02509117|2961717|Superiority or Other||Adjusted Mean Difference|-40.558|Standard Error of the Mean|0.0558|<|0.0001|2-Sided|80.0|-44.7|-36.1|||Mixed Model Repeated Measures|||ABeta x-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.|
1612932|NCT02509117|2961717|Superiority or Other||Adjusted Mean Difference|-86.152|Standard Error of the Mean|0.0643|<|0.0001|2-Sided|80.0|-87.26|-84.95|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.|
1612933|NCT02509117|2961717|Superiority or Other||Adjusted Mean Difference|-68.026|Standard Error of the Mean|0.0665|<|0.0001|2-Sided|80.0|-70.66|-65.16|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.|
1612934|NCT02509117|2961717|Superiority or Other||Adjusted Mean Difference|-58.659|Standard Error of the Mean|0.0642|<|0.0001|2-Sided|80.0|-61.95|-55.08|||Mixed Model Repeated Measures|||ABeta 1-40: General linear model with intervention, as the fixed effect and loge(baseline) as covariate.|
1612935|NCT02509078|2961769|Superiority||Risk Difference (RD)|-0.3||||0.93|2-Sided|95.0|-6.4|5.9|||Wald test for the difference of two prop||Estimated value is a percentage||
1612936|NCT02508480|2961792|Superiority|||||||0.978||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.|
1612937|NCT02508480|2961793|Superiority|||||||0.076||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.|
1612938|NCT02508480|2961794|Superiority|||||||0.597||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.|
1612939|NCT02508480|2961795|Superiority|||||||0.017||||||The p-value above is for the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.|
1612940|NCT02508480|2961796|Superiority|||||||0.917||||||The p-value is for group effect for tcpm_days_participated.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction. The p-value reported below is for group effect for tcpm_days_participated.|
1612941|NCT02508480|2961797|Superiority|||||||0.118||||||The p-value represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared on the intrapsychic foundations subscale using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.|
1612942|NCT02508480|2961797|Superiority|||||||0.25||||||The p-value above represents the overall group effect.|Mixed Models Analysis|||The two study arms were compared on the interpersonal function subscale using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.|
1612943|NCT02508480|2961798|Superiority|||||||0.135||||||The p-value above is for the overall group effect.|Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.|
1612944|NCT02508480|2961799|Superiority|||||||0.543||||||Group effect for Avoidant Coping.|Mixed Models Analysis|||"The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.~The p-value reported below is for group effect for Avoidant Coping."|
1612945|NCT02508480|2961799|Superiority|||||||0.884||||||Group effect for Proactive Coping|Mixed Models Analysis|||"The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction.~The p-value reported below is for group effect for Proactive Coping."|
1612946|NCT02508480|2961800|Superiority|||||||0.66|||||||Mixed Models Analysis|||The two study arms were compared using mixed models analysis controlling for baseline scores. Variables included in the model were- baseline score, group, time, and group by time interaction. The p-value reported below is for group effect.|
1612947|NCT02508259|2961801|Equivalence|In this analysis, the child-specific RBQ score was tested for equivalence before and 6-weeks after suramin treatment.|Mean Difference (Net)|-3.2|Standard Deviation|5.8||0.28|2-Sided|95.0|-10.4|4.0|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.|
1612948|NCT02508259|2961802|Equivalence|In this analysis, overall ASD symptom scores, measured by CGI were compared between suramin and placebo groups.|Mean Difference (Final Values)|-1.8|Standard Deviation|1.04||0.05|2-Sided|95.0|-3.4|-0.15|||ANOVA|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.|
1612949|NCT02508259|2961803|Equivalence|In this analysis, we tested the equivalence of the child-specific ATEC subscore for language before and 6-weeks after treatment with suramin.|Mean Difference (Net)|-2.0|Standard Deviation|1.4||0.034|2-Sided|95.0|-2.7|-0.49|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.|
1612950|NCT02508259|2961804|Equivalence|In this analysis, the null hypothesis was tested that the child-specific ABC subscores for stereotypy were unchanged before and after suramin treatment.|Mean Difference (Net)|-4.0|Standard Deviation|2.3||0.019|2-Sided|95.0|-6.9|-1.1|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.|
1612951|NCT02508259|2961805|Equivalence|The child-specific difference in EOWPVT scores were compared for equivalence before and 6-weeks after suramin treatment|Mean Difference (Net)|-4.2|Standard Deviation|8.3||0.32|2-Sided|95.0|-14.5|6.1|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.|
1612952|NCT02508259|2961806|Equivalence|The null hypothesis was that before and after treatment ADOS scores were equivalent.|Mean Difference (Net)|-1.6|Standard Deviation|0.55||0.0028|2-Sided|95.0|-2.3|-0.9|||t-test, 2 sided|||In this analysis, each child was used as their own control to examine before and after suramin treatment effects in a paired t-test design. This study was a small pilot study of safety and activity of suramin. The small subject numbers of just 5 per group make it impossible to draw any strong conclusions about efficacy. Future studies are required.|
1612953|NCT02508207|2961808|Other|||||||0.0002||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided||||
1612954|NCT02508207|2961809|Other|||||||0.3345|||||||t-test, 2 sided|p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|||
1612955|NCT02508207|2961810|Other|||||||0.0004||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided||||
1612956|NCT02508207|2961811|Other|||||||0.6841||||||p-value for within TEZ/IVA group was analyzed using a 2-sided, paired, t-test at a 5% level of significance.|t-test, 2 sided||||
1612957|NCT02508194|2961828|Superiority||Vaccine efficacy|-7.1|||||2-Sided|90.0|-106.9|44.3|||||The CI was estimated by an exact conditional method.|2 sided 90 percent (%) confidence interval (CI) was used to compare vaccine efficacy (VE). VE = ([1 - relative risk (RR)] *100%), where RR was the RR of ARA-RI in the MEDI7510 group compared with the placebo group. A lower bound of the 90% CI greater than (>) 0% would demonstrate the efficacy of MEDI7510.|
1612958|NCT02508116|2961830|Superiority|||||||0.27|||||||Log Rank|||The incidence of first MACE between the groups were compared by use of Kaplan-Meier estimators; statistical tests were based on log-rank tests.|
1612959|NCT02508116|2961832|Superiority||Odds Ratio (OR)|1.6||||0.03|2-Sided|95.0|1.07|2.42|||Regression, Logistic|||The sample size calculation was based on two factors: 1) the rate of pre-study prasugrel/ticagrelor use (~20%) and 2) anticipated increase in prasugrel/ticagrelor prescribing based on the frequency CYP2C19 LOF variants (~30-35%). We estimated a 15% difference in the use of prasugrel/ticagrelor in the two groups (35% in the genotyped group and 20% in the control group). A sample size of 138 per group (a total of 276) would provide 80% power at an alpha level of 0.05 to detect this difference.|
1612960|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||Mental health domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612961|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||Mental health domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612962|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||Role emotional domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612963|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||Role emotional domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612964|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||Social functioning domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612965|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||Social functioning domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612966|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||Vitality domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612967|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||Vitality domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612968|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||General health domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612969|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||General health domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612970|NCT02507752|2961839|Superiority or Other||||||<|0.001|||||||ANOVA|||Bodily pain domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612971|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||Bodily pain domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612972|NCT02507752|2961839|Superiority or Other||||||<|0.001|||||||ANOVA|||Role physical domain at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612973|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||Role physical domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612975|NCT02507752|2961839|Superiority or Other||||||=|0|||||||ANOVA|||Physical functioning domain at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612976|NCT02507752|2961840|Superiority or Other||||||=|0|||||||ANOVA|||Mental component score at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612977|NCT02507752|2961840|Superiority or Other||||||=|0|||||||ANOVA|||Physical component score at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612978|NCT02507752|2961841|Superiority or Other||||||<|0.001|||||||ANOVA|||Change in pain scale from screening to Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612979|NCT02507752|2961841|Superiority or Other||||||<|0.001|||||||ANOVA|||Change in pain scale from screening to Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612980|NCT02507752|2961842|Superiority or Other||||||=|0|||||||ANOVA|||Change in HAQ score from screening to Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612981|NCT02507752|2961842|Superiority or Other||||||=|0|||||||ANOVA|||Change in HAQ score from screening to Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612982|NCT02507752|2961843|Superiority or Other||||||<|0.001|||||||ANOVA|||Mean change from Baseline in patient global assessment at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612983|NCT02507752|2961843|Superiority or Other||||||<|0.001|||||||ANOVA|||Mean change from Baseline in patient global assessment at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612984|NCT02507752|2961844|Superiority or Other||||||<|0.001|||||||ANOVA|||Mean change from Baseline in DAS28 at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612985|NCT02507752|2961844|Superiority or Other||||||<|0.001|||||||ANOVA|||Mean change from Baseline in DAS28 at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612986|NCT02507752|2961845|Superiority or Other||||||<|0.001|||||||ANOVA|||Mean change from Baseline in TJC at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612987|NCT02507752|2961845|Superiority or Other||||||<|0.001|||||||ANOVA|||Mean change from Baseline in TJC at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612988|NCT02507752|2961846|Superiority or Other||||||<|0.001|||||||ANOVA|||Mean change from Baseline in SJC at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612989|NCT02507752|2961846|Superiority or Other||||||<|0.001|||||||ANOVA|||Mean change from Baseline in SJC at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612990|NCT02507752|2961847|Superiority or Other||||||=|0|||||||ANOVA|||Mean change from Baseline in CRP at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612991|NCT02507752|2961847|Superiority or Other||||||=|0|||||||ANOVA|||Mean change from Baseline in CRP at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612992|NCT02507752|2961848|Superiority or Other||||||=|0|||||||ANOVA|||Mean change from Baseline in ESR at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612993|NCT02507752|2961848|Superiority or Other||||||=|0|||||||ANOVA|||Mean change from Baseline in ESR at Week 12: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA)|
1612994|NCT02507752|2961850|Superiority or Other||||||=|0|||||||ANOVA|||Mental component score at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA).|
1612995|NCT02507752|2961850|Superiority or Other||||||<|0.001|||||||ANOVA|||Physical component score at Week 24: The statistical hypothesis (H0) that the change is equal to 0 is evaluated using the Repeated Measures Analysis of Variance (ANOVA).|
1612996|NCT02507349|2961869|Superiority|||||||0.0003|||||||Mixed Models Analysis||||
1612997|NCT02507349|2961870|Superiority||||||<|0.0001|||||||Mixed Models Analysis||||
1612998|NCT02507349|2961871|Superiority|||||||0.008|||||||Mixed Models Analysis|||Time-by-treatment interaction|
1612999|NCT02507349|2961872|Superiority|||||||0.0016|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)|
1613000|NCT02507349|2961872|Superiority|||||||0.1649|||||||Mixed Models Analysis|||Time-by-treatment interaction|
1613001|NCT02507349|2961873|Superiority|||||||0.0033|||||||Mixed Models Analysis|||Time-by-treatment interaction|
1613002|NCT02507349|2961874|Superiority|||||||0.0005|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)|
1613003|NCT02507349|2961874|Superiority|||||||0.2328|||||||Mixed Models Analysis|||Time-by-treatment interaction|
1613004|NCT02507349|2961875|Superiority|||||||0.0113|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)|
1613005|NCT02507349|2961875|Superiority|||||||0.8733|||||||Mixed Models Analysis|||Time-by-treatment interaction|
1613006|NCT02507349|2961876|Superiority|||||||0.094|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)|
1613007|NCT02507349|2961876|Superiority|||||||0.4677|||||||Mixed Models Analysis|||Time-by-treatment interaction|
1614114|NCT02503202|2962189|Other||Risk Difference (RD)|-1.1|||<|0.769|2-Sided|95.0|-8.2|6.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C||
1613008|NCT02507349|2961877|Superiority|||||||0.058|||||||Mixed Models Analysis|||Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)|
1613009|NCT02507349|2961877|Superiority|||||||0.7254|||||||Mixed Models Analysis|||Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)|
1613010|NCT02507349|2961877|Superiority|||||||0.0002|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.|
1613011|NCT02507349|2961877|Superiority|||||||0.0042|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if <=35; 1 if (35<age<=49); 2 if age >49|
1613012|NCT02507349|2961877|Superiority|||||||0.1969|||||||Mixed Models Analysis|||Test for change over time from baseline (Marginal Effect of Time)|
1613013|NCT02507349|2961877|Superiority|||||||0.6243|||||||Mixed Models Analysis|||Time-by-treatment interaction|
1613014|NCT02507349|2961878|Superiority|||||||0.9928|||||||Mixed Models Analysis|||Three-way interaction of Treatment, time, and subgroup of side effects. Subgroup of side effect= 0 if the response to the medication side effects question at baseline is 1, 2, or 3 (i.e. subgroup of participants who are minimally bothered by medication side effects at baseline); Subgroup of side effect= 1 if the response to the medication side effects question at baseline is 4-10 (i.e. subgroup of participants who are moderately or very bothered by medication side effects at baseline)|
1613015|NCT02507349|2961878|Superiority|||||||0.0482|||||||Mixed Models Analysis|||Three-way interaction effect of time, treatment, and the basis subgroups (no symptoms =group 1; at least 1 severe symptom = group 2)|
1613016|NCT02507349|2961878|Superiority|||||||0.3164|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and SMI group). Participants with a diagnosis of major depression, schizoaffective or schizophrenia were classified into the SMI group and the reference group (Non-SMI) included diagnosis of anxiety, PTSD, depression/dysthymia/depression nos.|
1613017|NCT02507349|2961878|Superiority|||||||0.0033|||||||Mixed Models Analysis|||Three-way interaction effect (treatment, polynomial time, and age group 1) where age group 1 is defined by 0 (reference) if <=35; 1 if (35<age<=49); 2 if age >49.|
1613018|NCT02507349|2961878|Superiority||||||<|0.0001|||||||Mixed Models Analysis|||Time-by-treatment interaction|
1613019|NCT02507219|2961879|Superiority||Slope|-0.00012||||0.221|2-Sided|95.0|-0.0003|0.000067|||Mixed Models Analysis||Slope is the percent signal change per mg of ibuprofen.|A linear mixed effects model was run for the right amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.|
1613020|NCT02507219|2961879|Superiority||Slope|0.000055||||0.512|2-Sided|95.0|-0.00011|0.00022|||Mixed Models Analysis||Slope is percent signal change per milligram of ibuprofen.|A linear mixed effects model was run for the left amygdala with contrast and percent signal change between faces and shapes as the dependent variable and ibuprofen dose as a continuous predictor. Each subject had up to 3 visits and each visit contained 3 contrasts (happy - shape, angry - shape, fearful - shape) so subject and drug were used as random effects. Drug was nested inside of subject.|
1613021|NCT02506816|2961910|Other|The differences in the change from baseline of different biomarkers were evaluated by the P-valor Wilcoxon method, a non-parametric statistical hypothesis test.||||||0.03||||||In order to adjust the multiple comparisons made, Benjamini-Hochberg's false discovery rate (FDR) 10% method was used.|Wilcoxon (Mann-Whitney)|||After having analyzed the H-score for each of several biomarkers, we calculated the change from baseline subtracting post-treatment H-score from baseline H-score. Data were expressed as mean value and relative standard deviation.|
1613022|NCT02506816|2961911|Other|The P-valor Wilcoxon method is a non-parametric statistical hypothesis test used to evaluate changes from baseline H-score values of the three biomarkers.||||||0.033||||||In order to adjust the multiple comparisons made, Benjamini–Hochberg’s false discovery rate (FDR) 10% method was used.|Wilcoxon (Mann-Whitney)|||After having analyzed the H-score for each of 3 biomarkers, we calculated the change from baseline subtracting post-treatment H-score from baseline H-score. Data were expressed as mean value and relative standard deviation.|
1613023|NCT02505542|2961978|Other||LS Mean Difference vs Placebo|-0.3|Standard Error of the Mean|0.19|=|0|2-Sided|95.0|-0.73|0.03|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."|
1613024|NCT02505542|2961978|Other||LS Mean Difference vs Placebo|-0.4|Standard Error of the Mean|0.19|=|0|2-Sided|95.0|-0.78|-0.02|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."|
1613025|NCT02505542|2961979|Other||LS Mean Difference vs Placebo|-0.6|Standard Error of the Mean|0.76|=|0|2-Sided|95.0|-2.11|0.91|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."|
1615070|NCT02473471|2964572|Other|||||||0.092|||||||t-test, 2 sided|||1 hour after intervention|
1613026|NCT02505542|2961979|Other||LS Mean Difference vs Placebo|-1.0|Standard Error of the Mean|0.76|=|0|2-Sided|95.0|-2.5|0.51|||ANCOVA|||"Only MRIs performed ± 2 weeks around the Week 96 or Early Withdrawal Visit were assigned to Week 96 or Early Withdrawal.~Only results of the double-read assessments of the central MRI review were included. The analysis used the average of the scores from the 2 independent reviewers. Whenever an adjudication was present, the average score across all 3 reviewers was used.~ANCOVA model with treatment, geographical region, mNY classification, and Part B Baseline as covariates."|
1613027|NCT02505542|2961980|Superiority||Odds Ratio (OR)|12.02|||<|0.001|2-Sided|95.0|6.255|23.098|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.|
1613028|NCT02505542|2961980|Superiority||Odds Ratio (OR)|18.308|||<|0.001|2-Sided|95.0|9.084|36.898|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.|
1613029|NCT02505542|2961981|Other||LS Mean Difference vs Placebo|-0.24|Standard Error of the Mean|0.113|=|0|2-Sided|95.0|-0.46|-0.02|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.|
1613030|NCT02505542|2961981|Other||LS Mean Difference vs Placebo|-0.2|Standard Error of the Mean|0.112|=|0|2-Sided|95.0|-0.42|0.02|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.|
1613031|NCT02505542|2961982|Other||LS Mean Difference vs Placebo|-1.43|Standard Error of the Mean|0.238|<|0.001|2-Sided|95.0|-1.9|-0.96|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.|
1613032|NCT02505542|2961982|Other||LS Mean Difference vs Placebo|-1.57|Standard Error of the Mean|0.238|<|0.001|2-Sided|95.0|-2.04|-1.11|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.|
1613033|NCT02505542|2961983|Other||LS Mean Difference vs Placebo|-2.24|Standard Error of the Mean|0.267|<|0.001|2-Sided|95.0|-2.77|-1.72|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.|
1613034|NCT02505542|2961983|Other||LS Mean Difference vs Placebo|-2.46|Standard Error of the Mean|0.268|<|0.001|2-Sided|95.0|-2.99|-1.94|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.|
1613035|NCT02505542|2961984|Other||LS Mean Difference vs Placebo|-1.21|Standard Error of the Mean|0.126|<|0.001|2-Sided|95.0|-1.45|-0.96|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.|
1613036|NCT02505542|2961984|Other||LS Mean Difference vs Placebo|-1.42|Standard Error of the Mean|0.126|<|0.001|2-Sided|95.0|-1.66|-1.17|||Mixed Models Analysis|||An mixed model with repeated measures (MMRM) analysis on all observed post-baseline data with the following fixed-effect covariates was used: treatment, geographical region, mNY classification, Part B Baseline value, and visit as fixed-effect factors, as well as treatment group by visit interaction and Part B Baseline value by visit interaction.|
1613037|NCT02505542|2961985|Superiority||Odds Ratio (OR)|11.503|||<|0.001|2-Sided|95.0|5.939|22.278|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.|
1613038|NCT02505542|2961985|Superiority||Odds Ratio (OR)|17.082|||<|0.001|2-Sided|95.0|8.561|34.085|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.|
1613039|NCT02505542|2961986|Superiority||Odds Ratio (OR)|12.072|||<|0.001|2-Sided|95.0|5.954|24.476|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.|
1613040|NCT02505542|2961986|Superiority||Odds Ratio (OR)|16.9|||<|0.001|2-Sided|95.0|8.211|34.785|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.|
1613041|NCT02505542|2961987|Superiority||Odds Ratio (OR)|10.377|||<|0.001|2-Sided|95.0|5.456|19.738|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.|
1613042|NCT02505542|2961987|Superiority||Odds Ratio (OR)|20.891|||<|0.001|2-Sided|95.0|10.21|42.744|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.|
1613043|NCT02505542|2961988|Superiority||Odds Ratio (OR)|12.07|||<|0.001|2-Sided|95.0|6.275|23.218|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.|
1613970|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613044|NCT02505542|2961988|Superiority||Odds Ratio (OR)|20.205|||<|0.001|2-Sided|95.0|9.851|41.439|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and mNY classification.|
1613045|NCT02505542|2961989|Superiority||Odds Ratio (OR)|11.863|||<|0.001|2-Sided|95.0|5.67|24.822|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.|
1613046|NCT02505542|2961989|Superiority||Odds Ratio (OR)|17.653|||<|0.001|2-Sided|95.0|8.333|37.399|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.|
1613047|NCT02505542|2961989|Superiority||Odds Ratio (OR)|11.385|||<|0.001|2-Sided|95.0|5.952|21.778|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.|
1613048|NCT02505542|2961989|Superiority||Odds Ratio (OR)|17.94|||<|0.001|2-Sided|95.0|8.95|35.961|||Regression, Logistic|||Odds ratios (and corresponding p-values) were from a logistic regression model with factors for treatment group, geographical region, and modified New York (mNY) classification.|
1613049|NCT02505542|2961991|Other||||||<|0.001|||||||Log Rank|||P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q4W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).|
1613050|NCT02505542|2961991|Other||||||<|0.001|||||||Log Rank|||P-values were from stratified log-rank test comparing the Certolizumab pegol 200 mg Q2W Double-Blind (RS) group with the Placebo Double-Blind (RS) group (Geographic region and modified New York (mNY) classification were used as stratification factors).|
1613051|NCT02505542|2961995|Superiority||Odds Ratio (OR)|14.069|||<|0.001|2-Sided|95.0|7.395|27.955||A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.|Regression, Logistic|||Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio > 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.|
1613052|NCT02505542|2961995|Superiority||Odds Ratio (OR)|18.822|||<|0.001|2-Sided|95.0|9.605|38.864||A fixed sequence testing procedure was used whereby the second test (CZP 200 mg Q4W vs PBO) was interpreted as statistically significant only if the first test (CZP 200 mg Q2W vs PBO) was significant at the 0.05 level as well.|Regression, Logistic|||Odds ratio (and corresponding p-value) resulted from a logistic regression model with factors for treatment, geographic region, and modified New York (mNY) classification for study participants who did not experience a flare. An odds ratio > 1 indicates a study participant on CZP was more likely not to experience a flare than a study participant on placebo. Penalized maximum likelihood approach was used for logistic regression.|
1613053|NCT02505334|2962056|Superiority|Superiority of liraglutide 1.8 mg/day vs. liraglutide 0.9 mg/day was to be considered confirmed if the 95% confidence interval for the treatment difference (liraglutide 1.8 mg/day minus liraglutide 0.9 mg/day) for change from baseline in HbA1c (% of HbA1c) was entirely below 0%, equivalent to a one-sided test with significance level of 2.5%.|Treatment difference|-0.4|||<|0.0001|2-Sided|95.0|-0.55|-0.24|||ANCOVA|||Missing data was imputed using the LOCF method. The change from baseline in the response after 26 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline response as a covariate.|
1613054|NCT02505217|2962058|Superiority|||||||0.007|||||||Regression, Cox||||
1613055|NCT02504775|2962068|Non-Inferiority or Equivalence|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|106.132|||||2-Sided|90.0|85.151|132.283|||||||
1613056|NCT02504775|2962069|Non-Inferiority or Equivalence|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|95.989|||||2-Sided|90.0|89.826|102.574|||||||
1613057|NCT02504775|2962070|Non-Inferiority or Equivalence|Log-transformed PK parameter was compared between products using a linear mixed effects model including terms for product, period, sequence as fixed effect and subject nested within sequence as random effect. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Ratio of Averages of Tylenol/Mejoral|94.704|||||2-Sided|90.0|88.329|101.54|||||||
1613058|NCT02504671|2962080|Other||Mean Difference (Net)|-0.58||||0.432|2-Sided|95.0|-2.02|0.87||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score||
1613059|NCT02504671|2962080|Other||Mean Difference (Net)|-0.76||||0.324|2-Sided|95.0|-2.28|0.76||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score||
1613060|NCT02504671|2962080|Other||Mean Difference (Net)|-1.57||||0.001|2-Sided|95.0|-2.53|-0.62||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score||
1613061|NCT02504671|2962080|Other||Mean Difference (Net)|-1.44||||0.003|2-Sided|95.0|-2.4|-0.48||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score||
1613062|NCT02504671|2962080|Other||Mean Difference (Net)|-0.93||||0.059|2-Sided|95.0|-1.89|0.03||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score||
1613063|NCT02504671|2962080|Other||Mean Difference (Net)|-1.26||||0.01|2-Sided|95.0|-2.22|-0.3||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score||
1613064|NCT02504671|2962080|Other||Mean Difference (Net)|-0.2||||0.788|2-Sided|95.0|-1.68|1.28||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score||
1613065|NCT02504671|2962080|Other||Mean Difference (Net)|0.07||||0.928|2-Sided|95.0|-1.43|1.57||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score||
1613066|NCT02504671|2962080|Other||Mean Difference (Net)|-0.36||||0.656|2-Sided|95.0|-1.94|1.23||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, BFI score||
1613067|NCT02504671|2962080|Other||Mean Difference (Net)|-1.39||||0.004|2-Sided|95.0|-2.34|-0.45||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score||
1613068|NCT02504671|2962080|Other||Mean Difference (Net)|-1.2||||0.014|2-Sided|95.0|-2.16|-0.24||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score||
1613069|NCT02504671|2962080|Other||Mean Difference (Net)|-0.64||||0.191|2-Sided|95.0|-1.6|0.32||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, BFI score||
1613070|NCT02504671|2962080|Other||Mean Difference (Net)|-0.99||||0.041|2-Sided|95.0|-1.95|-0.04||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score||
1613071|NCT02504671|2962080|Other||Mean Difference (Net)|-0.5||||0.307|2-Sided|95.0|-1.46|0.46||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score||
1613072|NCT02504671|2962080|Other||Mean Difference (Net)|-0.07||||0.888|2-Sided|95.0|-1.04|0.9||MMRM analysis adjusted for BFI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, BFI score||
1613073|NCT02504671|2962081|Other||Mean Difference (Net)|1.87||||0.511|2-Sided|95.0|-3.74|7.48||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score||
1613074|NCT02504671|2962081|Other||Mean Difference (Net)|0.73||||0.808|2-Sided|95.0|-5.19|6.64||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score||
1613075|NCT02504671|2962081|Other||Mean Difference (Net)|5.33||||0.004|2-Sided|95.0|1.77|8.89||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score||
1613076|NCT02504671|2962081|Other||Mean Difference (Net)|3.92||||0.032|2-Sided|95.0|0.34|7.49||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score||
1613077|NCT02504671|2962081|Other||Mean Difference (Net)|2.81||||0.094|2-Sided|95.0|-0.48|6.1||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score||
1613078|NCT02504671|2962081|Other||Mean Difference (Net)|3.57||||0.033|2-Sided|95.0|0.29|6.85||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score||
1613079|NCT02504671|2962081|Other||Mean Difference (Net)|-0.81||||0.78|2-Sided|95.0|-6.58|4.95||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,FACIT score||
1613080|NCT02504671|2962081|Other||Mean Difference (Net)|-0.47||||0.874|2-Sided|95.0|-6.31|5.38||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score||
1613081|NCT02504671|2962081|Other||Mean Difference (Net)|0.76||||0.808|2-Sided|95.0|-5.4|6.92||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, FACIT score||
1613082|NCT02504671|2962081|Other||Mean Difference (Net)|3.08||||0.087|2-Sided|95.0|-0.46|6.61||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score||
1613083|NCT02504671|2962081|Other||Mean Difference (Net)|6.11||||0.163|2-Sided|95.0|-1.04|6.11||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT sscore||
1613084|NCT02504671|2962081|Other||Mean Difference (Net)|1.92||||0.292|2-Sided|95.0|-1.66|5.5||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, FACIT score||
1613085|NCT02504671|2962081|Other||Mean Difference (Net)|2.55||||0.125|2-Sided|95.0|-0.71|5.81||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score||
1613086|NCT02504671|2962081|Other||Mean Difference (Net)|1.5||||0.37|2-Sided|95.0|-1.79|4.78||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score||
1613087|NCT02504671|2962081|Other||Mean Difference (Net)|-0.65||||0.701|2-Sided|95.0|-3.97|2.67||MMRM analysis adjusted for FACIT Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, FACIT score||
1613088|NCT02504671|2962082|Other||Mean Difference (Net)|3.13||||0.328|2-Sided|95.0|-3.18|9.44||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality||
1613089|NCT02504671|2962082|Other||Mean Difference (Net)|3.36||||0.321|2-Sided|95.0|-3.31|10.02||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Vitality||
1613090|NCT02504671|2962082|Other||Mean Difference (Net)|3.97||||0.051|2-Sided|95.0|-0.01|7.95||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Vitality||
1613091|NCT02504671|2962082|Other||Mean Difference (Net)|2.64||||0.193|2-Sided|95.0|-1.35|6.64||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Vitality||
1613092|NCT02504671|2962082|Other||Mean Difference (Net)|3.34||||0.087|2-Sided|95.0|-0.49|7.17||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Vitality||
1613093|NCT02504671|2962082|Other||Mean Difference (Net)|4.64||||0.018|2-Sided|95.0|0.82|8.46||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality||
1613094|NCT02504671|2962082|Other||Mean Difference (Net)|0.3||||0.927|2-Sided|95.0|-6.11|6.7||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning||
1613095|NCT02504671|2962082|Other||Mean Difference (Net)|-0.33||||0.923|2-Sided|95.0|-7.15|6.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Social Functioning||
1613096|NCT02504671|2962082|Other||Mean Difference (Net)|4.35||||0.043|2-Sided|95.0|0.14|8.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Social Functioning||
1613097|NCT02504671|2962082|Other||Mean Difference (Net)|1.98||||0.359|2-Sided|95.0|-2.26|6.21||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Social Functioning||
1613098|NCT02504671|2962082|Other||Mean Difference (Net)|3.4||||0.109|2-Sided|95.0|-0.77|7.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Social Functioning||
1613099|NCT02504671|2962082|Other||Mean Difference (Net)|2.95||||0.165|2-Sided|95.0|-1.22|7.11||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Social Functioning||
1613100|NCT02504671|2962082|Other||Mean Difference (Net)|0.87||||0.737|2-Sided|95.0|-4.22|5.95||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role physical||
1613101|NCT02504671|2962082|Other||Mean Difference (Net)|1.21||||0.657|2-Sided|95.0|-4.16|6.57||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role physical||
1613102|NCT02504671|2962082|Other||Mean Difference (Net)|3.35||||0.061|2-Sided|95.0|-0.16|6.86||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role physical||
1613103|NCT02504671|2962082|Other||Mean Difference (Net)|1.43||||0.423|2-Sided|95.0|-2.08|4.94||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role physical||
1613104|NCT02504671|2962082|Other||Mean Difference (Net)|2.66||||0.094|2-Sided|95.0|-0.46|5.77||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role physical||
1613105|NCT02504671|2962082|Other||Mean Difference (Net)|1.88||||0.234|2-Sided|95.0|-1.22|4.98||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role physical||
1613106|NCT02504671|2962082|Other||Mean Difference (Net)|2.52||||0.412|2-Sided|95.0|-3.54|8.59||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role emotional||
1613107|NCT02504671|2962082|Other||Mean Difference (Net)|0.41||||0.901|2-Sided|95.0|-6.03|6.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Role emotional||
1613108|NCT02504671|2962082|Other||Mean Difference (Net)|2.68||||0.23|2-Sided|95.0|-1.71|7.07||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role emotional||
1613109|NCT02504671|2962082|Other||Mean Difference (Net)|1.08||||0.631|2-Sided|95.0|-3.34|5.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Role emotional||
1613110|NCT02504671|2962082|Other||Mean Difference (Net)|-0.6||||0.773|2-Sided|95.0|-4.7|3.5||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role emotional||
1613111|NCT02504671|2962082|Other||Mean Difference (Net)|0.59||||0.778|2-Sided|95.0|-3.51|4.69||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Role emotional||
1613112|NCT02504671|2962082|Other||Mean Difference (Net)|0.65||||0.793|2-Sided|95.0|-4.24|5.55||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Physical functioning||
1613113|NCT02504671|2962082|Other||Mean Difference (Net)|0.47||||0.856|2-Sided|95.0|-4.66|5.61||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Physical functioning||
1613114|NCT02504671|2962082|Other||Mean Difference (Net)|2.54||||0.014|2-Sided|95.0|0.97|8.61||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Physical functioning||
1613115|NCT02504671|2962082|Other||Mean Difference (Net)|2.87||||0.145|2-Sided|95.0|-0.99|6.73||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Physical functioning||
1613116|NCT02504671|2962082|Other||Mean Difference (Net)|2.45||||0.147|2-Sided|95.0|-0.87|5.77||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Physical functioning||
1613117|NCT02504671|2962082|Other||Mean Difference (Net)|1.88||||0.268|2-Sided|95.0|-1.45|5.21||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Physical functioning||
1613118|NCT02504671|2962082|Other||Mean Difference (Net)|5.01||||0.099|2-Sided|95.0|-0.96|10.98||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24,Mental health||
1613119|NCT02504671|2962082|Other||Mean Difference (Net)|2.15||||0.503|2-Sided|95.0|-4.18|8.49||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Mental health||
1613120|NCT02504671|2962082|Other||Mean Difference (Net)|3.45||||0.125|2-Sided|95.0|-0.96|7.85||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Mental health||
1613121|NCT02504671|2962082|Other||Mean Difference (Net)|2.4||||0.287|2-Sided|95.0|-2.03|6.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Mental health||
1613122|NCT02504671|2962082|Other||Mean Difference (Net)|0.05||||0.979|2-Sided|95.0|-3.94|4.05||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Mental health||
1613123|NCT02504671|2962082|Other||Mean Difference (Net)|-0.15||||0.941|2-Sided|95.0|-4.15|3.84||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Mental health||
1613124|NCT02504671|2962082|Other||Mean Difference (Net)|3.35||||0.198|2-Sided|95.0|-1.77|8.46||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, General health||
1613125|NCT02504671|2962082|Other||Mean Difference (Net)|1.77||||0.516|2-Sided|95.0|-3.62|7.17||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, General health||
1613126|NCT02504671|2962082|Other||Mean Difference (Net)|2.29||||0.138|2-Sided|95.0|-0.74|5.33||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, General health||
1613127|NCT02504671|2962082|Other||Mean Difference (Net)|0.69||||0.654|2-Sided|95.0|-2.36|3.74||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, General health||
1613128|NCT02504671|2962082|Other||Mean Difference (Net)|1.94||||0.199|2-Sided|95.0|-1.03|4.91||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, General health||
1613129|NCT02504671|2962082|Other||Mean Difference (Net)|1.65||||0.275|2-Sided|95.0|-1.32|4.62||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, General health||
1613130|NCT02504671|2962082|Other||Mean Difference (Net)|5.2||||0.078|2-Sided|95.0|-0.58|10.97||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Bodily pain||
1613131|NCT02504671|2962082|Other||Mean Difference (Net)|4.72||||0.134|2-Sided|95.0|-1.47|10.9||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 24, Bodily pain||
1613132|NCT02504671|2962082|Other||Mean Difference (Net)|3.43||||0.059|2-Sided|95.0|-0.13|6.99||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Bodily pain||
1613133|NCT02504671|2962082|Other||Mean Difference (Net)|2.11||||0.249|2-Sided|95.0|-1.49|5.7||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 12, Bodily pain||
1613134|NCT02504671|2962082|Other||Mean Difference (Net)|5.08|||<|0.001|2-Sided|95.0|2.14|8.03||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Bodily pain||
1613135|NCT02504671|2962082|Other||Mean Difference (Net)|3.45|||<|0.023|2-Sided|95.0|0.49|6.41||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions|MMRM||Week 4, Bodily pain||
1613136|NCT02504671|2962082|Other||Mean Difference (Net)|3.79|||<|0.203|2-Sided|95.0|-4.85|7.56||MMRM analysis adjusted for Baseline, treatment group, visit, treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS||
1613137|NCT02504671|2962082|Other||Mean Difference (Net)|1.36|||<|0.667|2-Sided|95.0|-4.85|7.56||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS||
1613138|NCT02504671|2962082|Other||Mean Difference (Net)|3.25|||<|0.138|2-Sided|95.0|-1.05|7.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS||
1613139|NCT02504671|2962082|Other||Mean Difference (Net)|1.97|||<|0.37|2-Sided|95.0|-2.35|6.28||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS||
1613140|NCT02504671|2962082|Other||Mean Difference (Net)|0.1|||<|0.964|2-Sided|95.0|-4.01|4.2||MMRM analysis adjusted for MCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS||
1613141|NCT02504671|2962082|Other||Mean Difference (Net)|1.16|||<|0.577|2-Sided|95.0|-2.94|5.26||MMRM analysis adjusted for MCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS||
1613142|NCT02504671|2962082|Other||Mean Difference (Net)|1.65|||<|0.493|2-Sided|95.0|-3.09|6.39||MMRM analysis adjusted for PCS Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS||
1613143|NCT02504671|2962082|Other||Mean Difference (Net)|2.16|||<|0.392|2-Sided|95.0|-2.81|7.14||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS||
1613144|NCT02504671|2962082|Other||Mean Difference (Net)|3.55|||<|0.037|2-Sided|95.0|0.22|6.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,PCS||
1613145|NCT02504671|2962082|Other||Mean Difference (Net)|1.89|||<|0.264|2-Sided|95.0|-1.44|5.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,PCS||
1613146|NCT02504671|2962082|Other||Mean Difference (Net)|4.11|||<|0.006|2-Sided|95.0|1.22|7.01||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS||
1613147|NCT02504671|2962082|Other||Mean Difference (Net)|2.94|||<|0.045|2-Sided|95.0|0.06|5.83||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS||
1613148|NCT02504671|2962082|Other||Mean Difference (Net)|2.97|||<|0.37|2-Sided|95.0|-3.55|9.48||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality||
1613149|NCT02504671|2962082|Other||Mean Difference (Net)|3.15|||<|0.346|2-Sided|95.0|-3.44|9.73||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Vitality||
1613150|NCT02504671|2962082|Other||Mean Difference (Net)|1.94|||<|0.584|2-Sided|95.0|-5.04|8.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,Vitality||
1613151|NCT02504671|2962082|Other||Mean Difference (Net)|2.18|||<|0.279|2-Sided|95.0|-1.78|6.13||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality||
1613152|NCT02504671|2962082|Other||Mean Difference (Net)|2.91|||<|0.153|2-Sided|95.0|-1.09|6.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality||
1613153|NCT02504671|2962082|Other||Mean Difference (Net)|1.97|||<|0.334|2-Sided|95.0|-2.04|5.98||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Vitality||
1613154|NCT02504671|2962082|Other||Mean Difference (Net)|2.63|||<|0.174|2-Sided|95.0|-1.17|6.43||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality||
1613155|NCT02504671|2962082|Other||Mean Difference (Net)|3.56|||<|0.068|2-Sided|95.0|-0.26|7.39||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality||
1613156|NCT02504671|2962082|Other||Mean Difference (Net)|1.02|||<|0.603|2-Sided|95.0|-2.85|4.9||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Vitality||
1613157|NCT02504671|2962082|Other||Mean Difference (Net)|-3.79|||<|0.26|2-Sided|95.0|-10.42|2.84||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning||
1613158|NCT02504671|2962082|Other||Mean Difference (Net)|-0.44|||<|0.898|2-Sided|95.0|-7.16|6.29||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning||
1613159|NCT02504671|2962082|Other||Mean Difference (Net)|-2.89|||<|0.424|2-Sided|95.0|-10.02|4.24||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Social Functioning||
1613160|NCT02504671|2962082|Other||Mean Difference (Net)|0.28|||<|0.896|2-Sided|95.0|-3.91|4.46||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning||
1613161|NCT02504671|2962082|Other||Mean Difference (Net)|0.0|||>|0.999|2-Sided|95.0|-4.23|4.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning||
1613162|NCT02504671|2962082|Other||Mean Difference (Net)|0.55|||>|0.797|2-Sided|95.0|-3.69|4.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Social Functioning||
1613163|NCT02504671|2962082|Other||Mean Difference (Net)|0.57|||>|0.785|2-Sided|95.0|-3.56|4.71||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning||
1613164|NCT02504671|2962082|Other||Mean Difference (Net)|3.17|||>|0.135|2-Sided|95.0|-1.0|7.33||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning||
1613165|NCT02504671|2962082|Other||Mean Difference (Net)|-0.32|||>|0.88|2-Sided|95.0|-4.54|3.89||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Social Functioning||
1613166|NCT02504671|2962082|Other||Mean Difference (Net)|1.12|||>|0.675|2-Sided|95.0|-4.14|6.37||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical||
1613167|NCT02504671|2962082|Other||Mean Difference (Net)|-0.12|||>|0.965|2-Sided|95.0|-5.41|5.17||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical||
1613168|NCT02504671|2962082|Other||Mean Difference (Net)|1.26|||>|0.657|2-Sided|95.0|-4.34|6.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Physical||
1613169|NCT02504671|2962082|Other||Mean Difference (Net)|0.92|||>|0.6|2-Sided|95.0|-2.55|4.4||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical||
1613170|NCT02504671|2962082|Other||Mean Difference (Net)|1.72|||>|0.338|2-Sided|95.0|-1.8|5.23||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical||
1613171|NCT02504671|2962082|Other||Mean Difference (Net)|0.6|||>|0.736|2-Sided|95.0|-2.92|4.12||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Physical||
1613847|NCT02504671|2962091|Other||Difference|70.3|||||2-Sided|95.0|55.0|85.5|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613172|NCT02504671|2962082|Other||Mean Difference (Net)|2.41|||>|0.125|2-Sided|95.0|-0.67|5.49||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical||
1613173|NCT02504671|2962082|Other||Mean Difference (Net)|1.9|||>|0.229|2-Sided|95.0|-1.21|5.0||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical||
1613174|NCT02504671|2962082|Other||Mean Difference (Net)|0.86|||>|0.588|2-Sided|95.0|-2.28|4.01||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Physical||
1613175|NCT02504671|2962082|Other||Mean Difference (Net)|-1.3|||>|0.684|2-Sided|95.0|-7.59|4.99||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional||
1613176|NCT02504671|2962082|Other||Mean Difference (Net)|0.5|||>|0.876|2-Sided|95.0|-5.86|6.87||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional||
1613177|NCT02504671|2962082|Other||Mean Difference (Net)|0.91|||>|0.79|2-Sided|95.0|-5.81|7.63||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Role Emotional||
1613178|NCT02504671|2962082|Other||Mean Difference (Net)|0.24|||>|0.913|2-Sided|95.0|-4.12|4.61||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Emotional||
1613179|NCT02504671|2962082|Other||Mean Difference (Net)|0.66|||>|0.767|2-Sided|95.0|-3.74|5.07||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,Role Emotional||
1613180|NCT02504671|2962082|Other||Mean Difference (Net)|0.34|||>|0.881|2-Sided|95.0|-4.08|4.76||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Role Emotional||
1613181|NCT02504671|2962082|Other||Mean Difference (Net)|-1.03|||>|0.62|2-Sided|95.0|-5.1|3.05||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional||
1613182|NCT02504671|2962082|Other||Mean Difference (Net)|-1.29|||>|0.535|2-Sided|95.0|-5.39|2.81||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional||
1613183|NCT02504671|2962082|Other||Mean Difference (Net)|-1.29|||>|0.541|2-Sided|95.0|-5.44|2.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Role Emotional||
1613184|NCT02504671|2962082|Other||Mean Difference (Net)|0.23|||>|0.928|2-Sided|95.0|-4.8|5.26||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning||
1613185|NCT02504671|2962082|Other||Mean Difference (Net)|-0.41|||>|0.873|2-Sided|95.0|-5.49|4.67||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning||
1613186|NCT02504671|2962082|Other||Mean Difference (Net)|-0.64|||>|0.814|2-Sided|95.0|-5.98|4.7||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Physical Functioning||
1613187|NCT02504671|2962082|Other||Mean Difference (Net)|3.0|||>|0.12|2-Sided|95.0|-0.79|6.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning||
1613188|NCT02504671|2962082|Other||Mean Difference (Net)|3.01|||>|0.124|2-Sided|95.0|-0.83|6.86||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning||
1613189|NCT02504671|2962082|Other||Mean Difference (Net)|2.82|||>|0.151|2-Sided|95.0|-1.04|6.69||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Physical Functioning||
1613190|NCT02504671|2962082|Other||Mean Difference (Net)|1.53|||>|0.36|2-Sided|95.0|-1.76|4.83||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning||
1613191|NCT02504671|2962082|Other||Mean Difference (Net)|2.38|||>|0.159|2-Sided|95.0|-0.94|5.7||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning||
1613192|NCT02504671|2962082|Other||Mean Difference (Net)|0.66|||>|0.698|2-Sided|95.0|-2.71|4.04||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Physical Functioning||
1613193|NCT02504671|2962082|Other||Mean Difference (Net)|0.61|||>|0.844|2-Sided|95.0|-5.54|6.77||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health||
1613194|NCT02504671|2962082|Other||Mean Difference (Net)|3.28|||>|0.302|2-Sided|95.0|-2.98|9.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health||
1613195|NCT02504671|2962082|Other||Mean Difference (Net)|1.32|||>|0.693|2-Sided|95.0|-5.28|7.93||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Mental Health||
1613196|NCT02504671|2962082|Other||Mean Difference (Net)|2.5|||>|0.262|2-Sided|95.0|-1.88|6.89||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health||
1613197|NCT02504671|2962082|Other||Mean Difference (Net)|3.21|||>|0.154|2-Sided|95.0|-1.22|7.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health||
1614336|NCT02494401|2963015|Superiority|||||||0.008||||||p value 6 month comparison|Wilcoxon (Mann-Whitney)||||
1613198|NCT02504671|2962082|Other||Mean Difference (Net)|2.6|||>|0.25|2-Sided|95.0|-1.84|7.03||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Mental Health||
1613199|NCT02504671|2962082|Other||Mean Difference (Net)|-0.01|||>|0.994|2-Sided|95.0|-3.99|3.96||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health||
1613200|NCT02504671|2962082|Other||Mean Difference (Net)|0.88|||>|0.664|2-Sided|95.0|-3.11|4.87||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health||
1613201|NCT02504671|2962082|Other||Mean Difference (Net)|0.16|||>|0.95|2-Sided|95.0|-0.19|0.52||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Mental Health||
1613202|NCT02504671|2962082|Other||Mean Difference (Net)|2.53|||>|0.345|2-Sided|95.0|-2.74|7.79||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health||
1613203|NCT02504671|2962082|Other||Mean Difference (Net)|2.76|||>|0.307|2-Sided|95.0|-2.57|8.09||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health||
1613204|NCT02504671|2962082|Other||Mean Difference (Net)|3.29|||>|0.25|2-Sided|95.0|-2.34|8.93||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, General Health||
1613205|NCT02504671|2962082|Other||Mean Difference (Net)|0.57|||>|0.708|2-Sided|95.0|-2.44|3.59||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health||
1613206|NCT02504671|2962082|Other||Mean Difference (Net)|1.85|||>|0.233|2-Sided|95.0|-1.2|4.91||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health||
1613207|NCT02504671|2962082|Other||Mean Difference (Net)|0.63|||>|0.687|2-Sided|95.0|-2.43|3.68||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, General Health||
1613208|NCT02504671|2962082|Other||Mean Difference (Net)|0.12|||>|0.934|2-Sided|95.0|-2.83|3.08||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health||
1613209|NCT02504671|2962082|Other||Mean Difference (Net)|0.99|||>|0.513|2-Sided|95.0|-1.99|3.97||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health||
1613210|NCT02504671|2962082|Other||Mean Difference (Net)|-0.51|||>|0.738|2-Sided|95.0|-3.52|2.5||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, General Health||
1613211|NCT02504671|2962082|Other||Mean Difference (Net)|3.21|||>|0.29|2-Sided|95.0|-2.76|9.17||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain||
1613212|NCT02504671|2962082|Other||Mean Difference (Net)|5.05|||>|0.105|2-Sided|95.0|-1.07|11.16||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain||
1613213|NCT02504671|2962082|Other||Mean Difference (Net)|2.85|||>|0.384|2-Sided|95.0|-3.61|9.32||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Bodily Pain||
1613214|NCT02504671|2962082|Other||Mean Difference (Net)|2.08|||>|0.247|2-Sided|95.0|-1.45|5.62||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain||
1613215|NCT02504671|2962082|Other||Mean Difference (Net)|2.82|||>|0.122|2-Sided|95.0|-0.76|6.4||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain||
1613216|NCT02504671|2962082|Other||Mean Difference (Net)|1.53|||>|0.403|2-Sided|95.0|-2.07|5.12||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Bodily Pain||
1613217|NCT02504671|2962082|Other||Mean Difference (Net)|2.92|||>|0.051|2-Sided|95.0|-0.01|5.84||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain||
1613218|NCT02504671|2962082|Other||Mean Difference (Net)|3.73|||>|0.013|2-Sided|95.0|0.78|6.67||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain||
1613219|NCT02504671|2962082|Other||Mean Difference (Net)|-0.11|||>|0.941|2-Sided|95.0|-3.11|2.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Bodily Pain||
1613220|NCT02504671|2962082|Other||Mean Difference (Net)|-1.05|||>|0.732|2-Sided|95.0|-7.1|4.99||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS||
1613221|NCT02504671|2962082|Other||Mean Difference (Net)|2.29|||>|0.461|2-Sided|95.0|-3.84|8.42||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS||
1613222|NCT02504671|2962082|Other||Mean Difference (Net)|0.43|||>|0.895|2-Sided|95.0|-6.03|6.9||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, MCS||
1613223|NCT02504671|2962082|Other||Mean Difference (Net)|1.12|||>|0.605|2-Sided|95.0|-3.15|5.39||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS||
1613224|NCT02504671|2962082|Other||Mean Difference (Net)|1.46|||>|0.505|2-Sided|95.0|-2.85|5.77||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS||
1613225|NCT02504671|2962082|Other||Mean Difference (Net)|1.32|||>|0.548|2-Sided|95.0|-3.0|5.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, MCS||
1613226|NCT02504671|2962082|Other||Mean Difference (Net)|-0.54|||>|0.795|2-Sided|95.0|-4.61|3.54||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS||
1613227|NCT02504671|2962082|Other||Mean Difference (Net)|0.45|||>|0.83|2-Sided|95.0|-3.65|4.55||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS||
1613228|NCT02504671|2962082|Other||Mean Difference (Net)|-0.5|||>|0.811|2-Sided|95.0|-4.65|3.64||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, MCS||
1613229|NCT02504671|2962082|Other||Mean Difference (Net)|2.46|||>|0.32|2-Sided|95.0|-2.41|7.32||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS||
1613230|NCT02504671|2962082|Other||Mean Difference (Net)|1.28|||>|0.606|2-Sided|95.0|-3.63|6.2||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS||
1613231|NCT02504671|2962082|Other||Mean Difference (Net)|1.69|||>|0.521|2-Sided|95.0|-3.5|6.88||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, PCS||
1613232|NCT02504671|2962082|Other||Mean Difference (Net)|1.73|||>|0.302|2-Sided|95.0|-1.56|5.02||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS||
1613233|NCT02504671|2962082|Other||Mean Difference (Net)|2.42|||>|0.154|2-Sided|95.0|-0.91|5.75||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS||
1613234|NCT02504671|2962082|Other||Mean Difference (Net)|1.46|||>|0.39|2-Sided|95.0|-1.88|4.8||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, PCS||
1613235|NCT02504671|2962082|Other||Mean Difference (Net)|2.61|||>|0.074|2-Sided|95.0|-0.25|5.47||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS||
1613236|NCT02504671|2962082|Other||Mean Difference (Net)|3.19|||>|0.03|2-Sided|95.0|0.31|6.07||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS||
1613237|NCT02504671|2962082|Other||Mean Difference (Net)|0.6|||>|0.683|2-Sided|95.0|-2.31|3.52||MMRM analysis adjusted for Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, PCS||
1613238|NCT02504671|2962083|Other||Mean Difference (Net)|-16.7||||0.03|2-Sided|95.0|-31.79|-1.62||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score||
1613239|NCT02504671|2962083|Other||Mean Difference (Net)|-13.23||||0.102|2-Sided|95.0|-29.11|2.64||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score||
1613240|NCT02504671|2962083|Other||Mean Difference (Net)|-13.22||||0.048|2-Sided|95.0|-26.32|-0.13||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score||
1613241|NCT02504671|2962083|Other||Mean Difference (Net)|-13.91||||0.048|2-Sided|95.0|-27.68|-0.14||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score||
1613242|NCT02504671|2962083|Other||Mean Difference (Net)|-11.87||||0.099|2-Sided|95.0|-26.02|2.27||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score||
1613243|NCT02504671|2962083|Other||Mean Difference (Net)|-13.2||||0.084|2-Sided|95.0|-28.18|1.79||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score||
1613244|NCT02504671|2962083|Other||Mean Difference (Net)|-17.94|||<|0.001|2-Sided|95.0|-28.18|-7.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score||
1613245|NCT02504671|2962083|Other||Mean Difference (Net)|-12.0|||<|0.022|2-Sided|95.0|-22.27|-1.73||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score||
1613246|NCT02504671|2962083|Other||Mean Difference (Net)|-20.39|||<|0.001|2-Sided|95.0|-30.27|-10.52||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score||
1613247|NCT02504671|2962083|Other||Mean Difference (Net)|-16.51|||<|0.001|2-Sided|95.0|-26.38|-6.65||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score||
1613248|NCT02504671|2962083|Other||Mean Difference (Net)|-12.43|||<|0.009|2-Sided|95.0|-21.68|-3.19||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score||
1613249|NCT02504671|2962083|Other||Mean Difference (Net)|-7.36|||<|0.118|2-Sided|95.0|-16.62|1.89||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score||
1613250|NCT02504671|2962083|Other||Mean Difference (Net)|-13.96|||<|0.001|2-Sided|95.0|-22.47|-5.44||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score||
1613251|NCT02504671|2962083|Other||Mean Difference (Net)|-7.94|||<|0.068|2-Sided|95.0|-16.47|0.58||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score||
1613252|NCT02504671|2962083|Other||Mean Difference (Net)|-10.44|||<|0.009|2-Sided|95.0|-18.27|-2.6||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score||
1613253|NCT02504671|2962083|Other||Mean Difference (Net)|-7.85|||<|0.051|2-Sided|95.0|-15.72|0.03||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score||
1613254|NCT02504671|2962083|Other||Mean Difference (Net)|-5.63|||<|0.13|2-Sided|95.0|-12.93|1.67||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score||
1613255|NCT02504671|2962083|Other||Mean Difference (Net)|-4.93|||<|0.187|2-Sided|95.0|-12.26|2.41||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score||
1613256|NCT02504671|2962083|Other||Mean Difference (Net)|-12.07|||<|0.125|2-Sided|95.0|-27.55|3.41||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score||
1613257|NCT02504671|2962083|Other||Mean Difference (Net)|-10.14|||<|0.205|2-Sided|95.0|-25.87|5.58||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score||
1613258|NCT02504671|2962083|Other||Mean Difference (Net)|-6.38|||<|0.445|2-Sided|95.0|-22.84|10.07||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, Pain score||
1613259|NCT02504671|2962083|Other||Mean Difference (Net)|-13.49|||<|0.049|2-Sided|95.0|-26.91|-0.08||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score||
1613260|NCT02504671|2962083|Other||Mean Difference (Net)|-13.17|||<|0.058|2-Sided|95.0|-26.82|0.48||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score||
1613261|NCT02504671|2962083|Other||Mean Difference (Net)|-0.69|||<|0.924|2-Sided|95.0|-14.85|13.47||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, Pain score||
1613262|NCT02504671|2962083|Other||Mean Difference (Net)|-13.86|||<|0.062|2-Sided|95.0|-28.42|0.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score||
1613263|NCT02504671|2962083|Other||Mean Difference (Net)|-15.95|||<|0.034|2-Sided|95.0|-30.72|-1.19||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score||
1613264|NCT02504671|2962083|Other||Mean Difference (Net)|-4.89|||<|0.527|2-Sided|95.0|-20.15|10.36||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, Pain score||
1613265|NCT02504671|2962083|Other||Mean Difference (Net)|-18.18|||<|0.001|2-Sided|95.0|-28.35|-8.01||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score||
1613266|NCT02504671|2962083|Other||Mean Difference (Net)|-14.15|||<|0.007|2-Sided|95.0|-24.42|-3.87||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score||
1613267|NCT02504671|2962083|Other||Mean Difference (Net)|-7.02|||<|0.182|2-Sided|95.0|-17.36|3.32||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, Pain score||
1613268|NCT02504671|2962083|Other||Mean Difference (Net)|-13.94|||<|0.005|2-Sided|95.0|-23.72|-4.16||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score||
1613269|NCT02504671|2962083|Other||Mean Difference (Net)|-14.57|||<|0.004|2-Sided|95.0|-24.43|-4.7||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score||
1613270|NCT02504671|2962083|Other||Mean Difference (Net)|-5.61|||<|0.268|2-Sided|95.0|-15.57|4.34||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, Pain score||
1613271|NCT02504671|2962083|Other||Mean Difference (Net)|-8.36|||<|0.074|2-Sided|95.0|-17.55|0.83||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score||
1613272|NCT02504671|2962083|Other||Mean Difference (Net)|-8.02|||<|0.09|2-Sided|95.0|-17.3|1.26||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score||
1613273|NCT02504671|2962083|Other||Mean Difference (Net)|-4.49|||<|0.345|2-Sided|95.0|-13.83|4.85||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, Pain score||
1613274|NCT02504671|2962083|Other||Mean Difference (Net)|-12.21|||<|0.005|2-Sided|95.0|-20.67|-3.74||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score||
1613275|NCT02504671|2962083|Other||Mean Difference (Net)|-9.38|||<|0.031|2-Sided|95.0|-17.91|-0.86||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score||
1613276|NCT02504671|2962083|Other||Mean Difference (Net)|-3.03|||<|0.49|2-Sided|95.0|-11.67|5.61||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, Pain score||
1613277|NCT02504671|2962083|Other||Mean Difference (Net)|-7.58|||<|0.057|2-Sided|95.0|-15.4|0.23||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score||
1615071|NCT02473471|2964572|Other|||||||0.388|||||||t-test, 2 sided|||Immediate after intervention|
1613278|NCT02504671|2962083|Other||Mean Difference (Net)|-5.99|||<|0.133|2-Sided|95.0|-13.82|1.85||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score||
1613279|NCT02504671|2962083|Other||Mean Difference (Net)|-2.92|||<|0.469|2-Sided|95.0|-10.86|5.01||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, Pain score||
1613280|NCT02504671|2962083|Other||Mean Difference (Net)|-7.71|||<|0.039|2-Sided|95.0|-15.03|-0.39||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score||
1613281|NCT02504671|2962083|Other||Mean Difference (Net)|-2.76|||<|0.461|2-Sided|95.0|-10.13|4.6||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score||
1613282|NCT02504671|2962083|Other||Mean Difference (Net)|-2.45|||<|0.511|2-Sided|95.0|-9.81|4.9||MMRM analysis adjusted for Pain Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, Pain score||
1613283|NCT02504671|2962084|Other||Mean Difference (Final Values)|-0.2||||0.251|2-Sided|95.0|-0.53|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI||
1613284|NCT02504671|2962084|Other||Mean Difference (Net)|-0.08||||0.637|2-Sided|95.0|-0.44|0.27||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI||
1613285|NCT02504671|2962084|Other||Mean Difference (Net)|-0.21||||0.207|2-Sided|95.0|-0.54|0.12||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI||
1613286|NCT02504671|2962084|Other||Mean Difference (Net)|-0.15||||0.401|2-Sided|95.0|-0.49|0.2||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI||
1613287|NCT02504671|2962084|Other||Mean Difference (Net)|-0.01||||0.959|2-Sided|95.0|-0.34|0.32||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI||
1613288|NCT02504671|2962084|Other||Mean Difference (Net)|0.09||||0.607|2-Sided|95.0|-0.26|0.44||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI||
1613289|NCT02504671|2962084|Other||Mean Difference (Net)|-0.24||||0.059|2-Sided|95.0|-0.49|0.01||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI||
1613290|NCT02504671|2962084|Other||Mean Difference (Net)|-0.12||||0.34|2-Sided|95.0|-0.38|0.13||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI||
1613291|NCT02504671|2962084|Other||Mean Difference (Net)|-0.21||||0.071|2-Sided|95.0|-0.44|0.02||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI||
1613292|NCT02504671|2962084|Other||Mean Difference (Net)|-0.14||||0.238|2-Sided|95.0|-0.36|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI||
1613293|NCT02504671|2962084|Other||Mean Difference (Net)|-0.2||||0.065|2-Sided|95.0|-0.42|0.01||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI||
1613294|NCT02504671|2962084|Other||Mean Difference (Net)|0.01||||0.897|2-Sided|95.0|-0.2|0.23||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI||
1613295|NCT02504671|2962084|Other||Mean Difference (Net)|-0.18||||0.085|2-Sided|95.0|-0.38|0.02||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI||
1613296|NCT02504671|2962084|Other||Mean Difference (Net)|-0.07||||0.473|2-Sided|95.0|-0.28|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI||
1613297|NCT02504671|2962084|Other||Mean Difference (Net)|-0.09||||0.325|2-Sided|95.0|-0.26|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI||
1613298|NCT02504671|2962084|Other||Mean Difference (Net)|-0.08||||0.358|2-Sided|95.0|-0.26|0.09||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI||
1613299|NCT02504671|2962084|Other||Mean Difference (Net)|-0.09||||0.259|2-Sided|95.0|-0.23|0.06||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI||
1613300|NCT02504671|2962084|Other||Mean Difference (Net)|-0.04||||0.588|2-Sided|95.0|-0.19|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI||
1613301|NCT02504671|2962084|Other||Mean Difference (Net)|-0.09||||0.599|2-Sided|95.0|-0.44|0.25||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI||
1613302|NCT02504671|2962084|Other||Mean Difference (Net)|-0.07||||0.687|2-Sided|95.0|-0.42|0.28||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI||
1613303|NCT02504671|2962084|Other||Mean Difference (Net)|0.02||||0.902|2-Sided|95.0|-0.34|0.39||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24, HAQ-DI||
1613304|NCT02504671|2962084|Other||Mean Difference (Net)|-0.16||||0.34|2-Sided|95.0|-0.5|0.17||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI||
1614115|NCT02503202|2962189|Other||Risk Difference (RD)|4.6|||<|0.176|2-Sided|95.0|-2.1|11.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot B||
1613305|NCT02504671|2962084|Other||Mean Difference (Net)|-0.08||||0.66|2-Sided|95.0|-0.42|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI||
1613306|NCT02504671|2962084|Other||Mean Difference (Net)|-0.02||||0.91|2-Sided|95.0|-0.37|0.33||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20, HAQ-DI||
1613307|NCT02504671|2962084|Other||Mean Difference (Net)|-0.08||||0.647|2-Sided|95.0|-0.42|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI||
1613308|NCT02504671|2962084|Other||Mean Difference (Net)|0.12||||0.503|2-Sided|95.0|-0.23|0.46||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI||
1613309|NCT02504671|2962084|Other||Mean Difference (Net)|0.16||||0.364|2-Sided|95.0|-0.19|0.52||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16, HAQ-DI||
1613310|NCT02504671|2962084|Other||Mean Difference (Net)|-0.11||||0.398|2-Sided|95.0|-0.36|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI||
1613311|NCT02504671|2962084|Other||Mean Difference (Net)|-0.04||||0.74|2-Sided|95.0|-0.3|0.21||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI||
1613312|NCT02504671|2962084|Other||Mean Difference (Net)|-0.05||||0.71|2-Sided|95.0|-0.3|0.21||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12, HAQ-DI||
1613313|NCT02504671|2962084|Other||Mean Difference (Net)|-0.1||||0.395|2-Sided|95.0|-0.32|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI||
1613314|NCT02504671|2962084|Other||Mean Difference (Net)|-0.11||||0.327|2-Sided|95.0|-0.34|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI||
1613315|NCT02504671|2962084|Other||Mean Difference (Final Values)|0.04||||0.748|2-Sided|95.0|-0.19|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8, HAQ-DI||
1613316|NCT02504671|2962084|Other||Mean Difference (Net)|-0.1||||0.357|2-Sided|95.0|-0.31|0.11||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI||
1613317|NCT02504671|2962084|Other||Mean Difference (Net)|-0.04||||0.713|2-Sided|95.0|-0.25|0.17||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI||
1613318|NCT02504671|2962084|Other||Mean Difference (Net)|0.0||||0.987|2-Sided|95.0|-0.21|0.22||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6, HAQ-DI||
1613319|NCT02504671|2962084|Other||Mean Difference (Net)|-0.07||||0.473|2-Sided|95.0|-0.27|0.13||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI||
1613320|NCT02504671|2962084|Other||Mean Difference (Net)|0.05||||0.603|2-Sided|95.0|-0.15|0.26||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI||
1613321|NCT02504671|2962084|Other||Mean Difference (Net)|0.04||||0.707|2-Sided|95.0|-0.16|0.24||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4, HAQ-DI||
1613322|NCT02504671|2962084|Other||Mean Difference (Net)|-0.05||||0.545|2-Sided|95.0|-0.23|0.12||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI||
1613323|NCT02504671|2962084|Other||Mean Difference (Net)|0.01||||0.917|2-Sided|95.0|-0.16|0.18||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI||
1613324|NCT02504671|2962084|Other||Mean Difference (Net)|0.05||||0.592|2-Sided|95.0|-0.13|0.22||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2, HAQ-DI||
1613325|NCT02504671|2962084|Other||Mean Difference (Net)|-0.01||||0.857|2-Sided|95.0|-0.16|0.14||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI||
1613326|NCT02504671|2962084|Other||Mean Difference (Net)|0.0||||0.981|2-Sided|95.0|-0.15|0.15||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI||
1613327|NCT02504671|2962084|Other||Mean Difference (Net)|0.01||||0.938|2-Sided|95.0|-0.14|0.16||MMRM analysis adjusted for HAQ-DI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, HAQ-DI||
1613328|NCT02504671|2962085|Other||Mean Difference (Net)|-19.88|||<|0.001|2-Sided|95.0|-29.7|-10.06||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI||
1613329|NCT02504671|2962085|Other||Mean Difference (Net)|-15.43|||<|0.004|2-Sided|95.0|-25.78|-5.07||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI||
1613330|NCT02504671|2962085|Other||Mean Difference (Net)|-8.67|||<|0.034|2-Sided|95.0|-16.67|-0.67||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI||
1613331|NCT02504671|2962085|Other||Mean Difference (Net)|-6.55|||<|0.127|2-Sided|95.0|-14.99|1.89||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI||
1613971|NCT02504671|2962094|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613332|NCT02504671|2962085|Other||Mean Difference (Net)|-8.85|||<|0.022|2-Sided|95.0|-16.39|-1.32||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI||
1613333|NCT02504671|2962085|Other||Mean Difference (Net)|-5.53|||<|0.165|2-Sided|95.0|-13.37|2.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI||
1613334|NCT02504671|2962085|Other||Mean Difference (Net)|-16.63|||<|0.001|2-Sided|95.0|-23.97|-9.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI||
1613335|NCT02504671|2962085|Other||Mean Difference (Net)|-9.67|||<|0.01|2-Sided|95.0|-17.03|-2.31||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI||
1613336|NCT02504671|2962085|Other||Mean Difference (Net)|-13.79|||<|0.001|2-Sided|95.0|-20.18|-7.41||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI||
1613337|NCT02504671|2962085|Other||Mean Difference (Net)|-10.37|||<|0.002|2-Sided|95.0|-16.75|-4.0||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI||
1613338|NCT02504671|2962085|Other||Mean Difference (Net)|-10.17|||<|0.001|2-Sided|95.0|-15.97|-4.38||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI||
1613339|NCT02504671|2962085|Other||Mean Difference (Net)|-5.62|||<|0.059|2-Sided|95.0|-11.45|0.21||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI||
1613340|NCT02504671|2962085|Other||Mean Difference (Net)|-12.19|||<|0.001|2-Sided|95.0|-17.74|-6.64||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI||
1613341|NCT02504671|2962085|Other||Mean Difference (Net)|-7.92|||<|0.005|2-Sided|95.0|-13.48|-2.37||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI||
1613342|NCT02504671|2962085|Other||Mean Difference (Net)|-6.85|||<|0.007|2-Sided|95.0|-11.78|-1.91||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI||
1613343|NCT02504671|2962085|Other||Mean Difference (Net)|-6.1|||<|0.016|2-Sided|95.0|-11.06|-1.14||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI||
1613344|NCT02504671|2962085|Other||Mean Difference (Net)|-7.39|||<|0.001|2-Sided|95.0|-11.42|-3.36||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI||
1613345|NCT02504671|2962085|Other||Mean Difference (Net)|-3.89|||<|0.06|2-Sided|95.0|-7.96|0.17||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI||
1613346|NCT02504671|2962085|Other||Mean Difference (Net)|-14.91|||<|0.004|2-Sided|95.0|-25.01|-4.8||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI||
1613347|NCT02504671|2962085|Other||Mean Difference (Net)|-15.12|||<|0.004|2-Sided|95.0|-25.4|-4.83||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI||
1613348|NCT02504671|2962085|Other||Mean Difference (Net)|-9.37|||<|0.088|2-Sided|95.0|-20.15|1.42||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,CDAI||
1613349|NCT02504671|2962085|Other||Mean Difference (Net)|-5.9|||<|0.157|2-Sided|95.0|-14.09|2.3||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI||
1613350|NCT02504671|2962085|Other||Mean Difference (Net)|-5.39|||<|0.204|2-Sided|95.0|-13.75|2.96||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI||
1613351|NCT02504671|2962085|Other||Mean Difference (Net)|1.04|||<|0.812|2-Sided|95.0|-7.61|9.69||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,CDAI||
1613352|NCT02504671|2962085|Other||Mean Difference (Net)|-6.44|||<|0.099|2-Sided|95.0|-14.12|1.23||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI||
1613353|NCT02504671|2962085|Other||Mean Difference (Net)|-6.33|||<|0.11|2-Sided|95.0|-14.11|1.44||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI||
1613354|NCT02504671|2962085|Other||Mean Difference (Net)|-1.68|||<|0.676|2-Sided|95.0|-9.63|6.26||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,CDAI||
1613355|NCT02504671|2962085|Other||Mean Difference (Net)|-13.88|||<|0.001|2-Sided|95.0|-21.17|-6.59||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI||
1613356|NCT02504671|2962085|Other||Mean Difference (Net)|-9.8|||<|0.009|2-Sided|95.0|-17.17|-2.44||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI||
1613357|NCT02504671|2962085|Other||Mean Difference (Net)|-6.8|||<|0.071|2-Sided|95.0|-14.19|0.58||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,CDAI||
1613358|NCT02504671|2962085|Other||Mean Difference (Net)|-8.74|||<|0.007|2-Sided|95.0|-15.06|-2.43||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI||
1613359|NCT02504671|2962085|Other||Mean Difference (Net)|-8.6|||<|0.008|2-Sided|95.0|-14.97|-2.22||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI||
1613360|NCT02504671|2962085|Other||Mean Difference (Net)|-6.41|||<|0.051|2-Sided|95.0|-12.84|0.02||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,CDAI||
1613361|NCT02504671|2962085|Other||Mean Difference (Final Values)|-6.63|||<|0.024|2-Sided|95.0|-12.38|-0.87||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI||
1613362|NCT02504671|2962085|Other||Mean Difference (Net)|-5.85|||<|0.05|2-Sided|95.0|-11.69|0.0||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI||
1613363|NCT02504671|2962085|Other||Mean Difference (Net)|-5.48|||<|0.065|2-Sided|95.0|-11.31|0.35||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,CDAI||
1613364|NCT02504671|2962085|Other||Mean Difference (Net)|-9.19|||<|0.001|2-Sided|95.0|-14.73|-3.66||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI||
1613365|NCT02504671|2962085|Other||Mean Difference (Net)|-6.73|||<|0.018|2-Sided|95.0|-12.3|-1.16||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI||
1613366|NCT02504671|2962085|Other||Mean Difference (Net)|-7.2|||<|0.012|2-Sided|95.0|-12.82|-1.57||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,CDAI||
1613367|NCT02504671|2962085|Other||Mean Difference (Net)|-5.2|||<|0.039|2-Sided|95.0|-10.13|-0.27||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI||
1613368|NCT02504671|2962085|Other||Mean Difference (Net)|-3.47|||<|0.17|2-Sided|95.0|-8.43|1.49||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI||
1613369|NCT02504671|2962085|Other||Mean Difference (Net)|-4.17|||<|0.102|2-Sided|95.0|-9.17|0.84||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,CDAI||
1613370|NCT02504671|2962085|Other||Mean Difference (Net)|-4.43|||<|0.032|2-Sided|95.0|-8.46|-0.39||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI||
1613371|NCT02504671|2962085|Other||Mean Difference (Net)|-3.84|||<|0.067|2-Sided|95.0|-7.95|0.28||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI||
1613372|NCT02504671|2962085|Other||Mean Difference (Net)|-3.84|||<|0.063|2-Sided|95.0|-7.89|0.2||MMRM analysis adjusted for CDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,CDAI||
1613373|NCT02504671|2962086|Other||Mean Difference (Net)|-20.87|||<|0.001|2-Sided|95.0|-31.2|-10.53||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI||
1613374|NCT02504671|2962086|Other||Mean Difference (Net)|-15.88|||<|0.005|2-Sided|95.0|-26.77|-4.98||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI||
1613375|NCT02504671|2962086|Other||Mean Difference (Net)|-8.7|||<|0.04|2-Sided|95.0|-16.99|-0.42||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI||
1613376|NCT02504671|2962086|Other||Mean Difference (Net)|-6.59|||<|0.138|2-Sided|95.0|-15.32|2.14||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI||
1613377|NCT02504671|2962086|Other||Mean Difference (Net)|-9.43|||<|0.019|2-Sided|95.0|-17.32|-1.55||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI||
1613378|NCT02504671|2962086|Other||Mean Difference (Net)|-6.03|||<|0.149|2-Sided|95.0|-14.24|2.18||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI||
1613379|NCT02504671|2962086|Other||Mean Difference (Net)|-16.86|||<|0.001|2-Sided|95.0|-24.39|-9.32||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI||
1613380|NCT02504671|2962086|Other||Mean Difference (Net)|-9.68|||<|0.013|2-Sided|95.0|-17.26|-2.11||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI||
1613381|NCT02504671|2962086|Other||Mean Difference (Net)|-14.0|||<|0.001|2-Sided|95.0|-20.57|-7.44||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI||
1613382|NCT02504671|2962086|Other||Mean Difference (Net)|-11.18|||<|0.001|2-Sided|95.0|-17.7|-4.66||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI||
1613383|NCT02504671|2962086|Other||Mean Difference (Net)|-10.16|||<|0.001|2-Sided|95.0|-16.07|-4.24||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI||
1613384|NCT02504671|2962086|Other||Mean Difference (Net)|-7.0|||<|0.022|2-Sided|95.0|-12.99|-1.01||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI||
1613385|NCT02504671|2962086|Other||Mean Difference (Net)|-12.51|||<|0.001|2-Sided|95.0|-18.26|-6.75||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI||
1613386|NCT02504671|2962086|Other||Mean Difference (Net)|-8.44|||<|0.004|2-Sided|95.0|-14.2|-2.67||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI||
1613387|NCT02504671|2962086|Other||Mean Difference (Net)|-6.85|||<|0.008|2-Sided|95.0|-11.91|-1.78||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI||
1613388|NCT02504671|2962086|Other||Mean Difference (Net)|-6.67|||<|0.01|2-Sided|95.0|-11.74|-1.6||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI||
1613389|NCT02504671|2962086|Other||Mean Difference (Net)|-7.77|||<|0.001|2-Sided|95.0|-11.84|-3.7||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI||
1613390|NCT02504671|2962086|Other||Mean Difference (Net)|-4.78|||<|0.024|2-Sided|95.0|-8.91|-0.65||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI||
1613391|NCT02504671|2962086|Other||Mean Difference (Net)|-15.67|||<|0.004|2-Sided|95.0|-26.3|-5.03||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI||
1613392|NCT02504671|2962086|Other||Mean Difference (Net)|-16.37|||<|0.003|2-Sided|95.0|-27.25|-5.49||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI||
1613393|NCT02504671|2962086|Other||Mean Difference (Net)|-10.65|||<|0.066|2-Sided|95.0|-21.99|0.69||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24,SDAI||
1613394|NCT02504671|2962086|Other||Mean Difference (Net)|-6.0|||<|0.164|2-Sided|95.0|-14.48|2.48||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI||
1613395|NCT02504671|2962086|Other||Mean Difference (Net)|-5.71|||<|0.196|2-Sided|95.0|-14.4|2.99||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI||
1613396|NCT02504671|2962086|Other||Mean Difference (Net)|0.8|||<|0.86|2-Sided|95.0|-8.14|9.74||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20,SDAI||
1613397|NCT02504671|2962086|Other||Mean Difference (Net)|-7.26|||<|0.076|2-Sided|95.0|-15.3|0.78||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI||
1613398|NCT02504671|2962086|Other||Mean Difference (Net)|-7.0|||<|0.093|2-Sided|95.0|-15.19|1.19||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI||
1613399|NCT02504671|2962086|Other||Mean Difference (Net)|-1.88|||<|0.656|2-Sided|95.0|-10.19|6.43||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16,SDAI||
1613400|NCT02504671|2962086|Other||Mean Difference (Net)|-14.15|||<|0.001|2-Sided|95.0|-21.64|-6.67||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI||
1613401|NCT02504671|2962086|Other||Mean Difference (Net)|-10.37|||<|0.008|2-Sided|95.0|-17.99|-2.74||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI||
1613402|NCT02504671|2962086|Other||Mean Difference (Net)|-6.91|||<|0.074|2-Sided|95.0|-14.49|0.68||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12,SDAI||
1613403|NCT02504671|2962086|Other||Mean Difference (Net)|-8.86|||<|0.007|2-Sided|95.0|-15.32|-2.41||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI||
1613404|NCT02504671|2962086|Other||Mean Difference (Net)|-9.15|||<|0.006|2-Sided|95.0|-15.71|-2.6||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI||
1613405|NCT02504671|2962086|Other||Mean Difference (Net)|-6.58|||<|0.05|2-Sided|95.0|-13.15|-0.01||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8,SDAI||
1613406|NCT02504671|2962086|Other||Mean Difference (Net)|-6.79|||<|0.024|2-Sided|95.0|-12.69|-0.9||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI||
1613407|NCT02504671|2962086|Other||Mean Difference (Net)|-6.29|||<|0.04|2-Sided|95.0|-12.28|-0.3||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI||
1613408|NCT02504671|2962086|Other||Mean Difference (Net)|-5.65|||<|0.063|2-Sided|95.0|-11.62|0.32||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6,SDAI||
1613409|NCT02504671|2962086|Other||Mean Difference (Net)|-9.23|||<|0.002|2-Sided|95.0|-14.99|-3.47||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI||
1613410|NCT02504671|2962086|Other||Mean Difference (Net)|-7.28|||<|0.014|2-Sided|95.0|-13.09|-1.47||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI||
1613411|NCT02504671|2962086|Other||Mean Difference (Net)|-6.78|||<|0.023|2-Sided|95.0|-12.61|-0.94||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4,SDAI||
1613412|NCT02504671|2962086|Other||Mean Difference (Net)|-5.48|||<|0.034|2-Sided|95.0|-10.53|-0.42||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI||
1613413|NCT02504671|2962086|Other||Mean Difference (Net)|-4.72|||<|0.071|2-Sided|95.0|-9.85|0.4||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI||
1613414|NCT02504671|2962086|Other||Mean Difference (Net)|-4.06|||<|0.119|2-Sided|95.0|-9.18|1.05||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2,SDAI||
1613415|NCT02504671|2962086|Other||Mean Difference (Net)|-4.33|||<|0.038|2-Sided|95.0|-8.43|-0.23||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI||
1613416|NCT02504671|2962086|Other||Mean Difference (Net)|-3.66|||<|0.086|2-Sided|95.0|-7.84|0.52||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1,SDAI||
1613417|NCT02504671|2962086|Other||Mean Difference (Net)|-4.09|||<|0.05|2-Sided|95.0|-8.18|0.0||MMRM analysis adjusted for SDAI Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1, SDAI||
1613418|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613419|NCT02504671|2962087|Other||Difference|16.2|||||2-Sided|95.0|4.3|28.1|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613420|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613421|NCT02504671|2962087|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613422|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613423|NCT02504671|2962087|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613424|NCT02504671|2962087|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613425|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613426|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613427|NCT02504671|2962087|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613428|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613429|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613430|NCT02504671|2962087|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613431|NCT02504671|2962087|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613432|NCT02504671|2962087|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613433|NCT02504671|2962087|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613434|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613435|NCT02504671|2962087|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613436|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613437|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613438|NCT02504671|2962087|Other||5.4|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613439|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613440|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613441|NCT02504671|2962087|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614337|NCT02494401|2963015|Superiority|||||||0.05||||||p value 16 week comparison|Wilcoxon (Mann-Whitney)||||
1613442|NCT02504671|2962087|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613443|NCT02504671|2962087|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613444|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613445|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613446|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.6||
1613447|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613448|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613449|NCT02504671|2962087|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||CDAI, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613450|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613451|NCT02504671|2962087|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||CDAI, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613452|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613453|NCT02504671|2962087|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613454|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613455|NCT02504671|2962087|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613456|NCT02504671|2962087|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613457|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613458|NCT02504671|2962087|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613459|NCT02504671|2962087|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613460|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613461|NCT02504671|2962087|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613462|NCT02504671|2962087|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613463|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613464|NCT02504671|2962087|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613465|NCT02504671|2962087|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||CDAI, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613466|NCT02504671|2962087|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613467|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613468|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613469|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613470|NCT02504671|2962087|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613471|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613472|NCT02504671|2962087|Other||Difference|16.2|||||2-Sided|95.0|4.3|28.1|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613473|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613474|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613475|NCT02504671|2962087|Other||Difference|8.1|||||2-Sided|95.0|-3.2|19.4|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613476|NCT02504671|2962087|Other||Difference|-2.7|||||2-Sided|95.0|-7.9|2.5|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613477|NCT02504671|2962087|Other||Difference|-2.7|||||2-Sided|95.0|-7.9|2.5|||||CDAI, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613478|NCT02504671|2962087|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613479|NCT02504671|2962087|Other||Difference|-2.7|||||2-Sided|95.0|-7.9|2.5|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613480|NCT02504671|2962087|Other||Difference|-2.7|||||2-Sided|95.0|-7.9|2.5|||||CDAI, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613481|NCT02504671|2962087|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||CDAI, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613482|NCT02504671|2962087|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||CDAI, Week 4, Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613483|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613484|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613485|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613486|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613487|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613488|NCT02504671|2962088|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613489|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613490|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613491|NCT02504671|2962088|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613492|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613493|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613494|NCT02504671|2962088|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613495|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613496|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613497|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613498|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613499|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613972|NCT02504671|2962094|Other||Difference|24.3|||||2-Sided|95.0|10.5|38.1|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613500|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613501|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613502|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613503|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613504|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613505|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613506|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613507|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613508|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613509|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613510|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613511|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613512|NCT02504671|2962088|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613513|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613514|NCT02504671|2962088|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613515|NCT02504671|2962088|Other||Difference|21.6|||||2-Sided|95.0|0.4|42.8|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613516|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613517|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613518|NCT02504671|2962088|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613519|NCT02504671|2962088|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Boolean based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613520|NCT02504671|2962088|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613521|NCT02504671|2962088|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613522|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613523|NCT02504671|2962088|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613524|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613525|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613526|NCT02504671|2962088|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613527|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613528|NCT02504671|2962088|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613529|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613530|NCT02504671|2962088|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613531|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613532|NCT02504671|2962088|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Boolean based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613533|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613534|NCT02504671|2962088|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Boolean based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613535|NCT02504671|2962088|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Boolean based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613536|NCT02504671|2962089|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613537|NCT02504671|2962089|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613538|NCT02504671|2962089|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613539|NCT02504671|2962089|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613540|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613541|NCT02504671|2962089|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613542|NCT02504671|2962089|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613543|NCT02504671|2962089|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613544|NCT02504671|2962089|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613545|NCT02504671|2962089|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613546|NCT02504671|2962089|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613547|NCT02504671|2962089|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613548|NCT02504671|2962089|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613549|NCT02504671|2962089|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613550|NCT02504671|2962089|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613551|NCT02504671|2962089|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613552|NCT02504671|2962089|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613553|NCT02504671|2962089|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613554|NCT02504671|2962089|Other||Difference|5.4|||||2-Sided|95.0|-1.9|68.2|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613555|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|12.7|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613556|NCT02504671|2962089|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613557|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613558|NCT02504671|2962089|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613559|NCT02504671|2962089|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613560|NCT02504671|2962089|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613561|NCT02504671|2962089|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613562|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613563|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613564|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613565|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 2. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613566|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613567|NCT02504671|2962089|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 62 (follow-up). Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613568|NCT02504671|2962089|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613569|NCT02504671|2962089|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613570|NCT02504671|2962089|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 52. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613571|NCT02504671|2962089|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613572|NCT02504671|2962089|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613573|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 48. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613574|NCT02504671|2962089|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613575|NCT02504671|2962089|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613576|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 44. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613577|NCT02504671|2962089|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613578|NCT02504671|2962089|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613579|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 40. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613580|NCT02504671|2962089|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613581|NCT02504671|2962089|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613582|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 36. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613583|NCT02504671|2962089|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613584|NCT02504671|2962089|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 32. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613585|NCT02504671|2962089|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613586|NCT02504671|2962089|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 28. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613587|NCT02504671|2962089|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613588|NCT02504671|2962089|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 24. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613589|NCT02504671|2962089|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613590|NCT02504671|2962089|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Index based ACR/EULAR, Week 20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613591|NCT02504671|2962089|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613592|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 16. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613593|NCT02504671|2962089|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613594|NCT02504671|2962089|Other||Difference|-2.7|||||2-Sided|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613595|NCT02504671|2962089|Other||Difference|-2.7|||||2-Sided|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 12. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613596|NCT02504671|2962089|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613597|NCT02504671|2962089|Other||Difference|-2.7|||||2-Sided|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613598|NCT02504671|2962089|Other||Difference|-2.7|||||2-Sided|95.0|-7.9|2.5|||||Index based ACR/EULAR, Week 8. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613599|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 6. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613600|NCT02504671|2962089|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Index based ACR/EULAR, Week 4. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613601|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 62 (follow-up), ACR70. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613602|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 62 (follow-up), ACR70. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613603|NCT02504671|2962090|Other||Difference|24.3|||||2-Sided|95.0|9.1|39.6|||||Week 62 (follow-up), ACR50. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613604|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 62 (follow-up), ACR50. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613605|NCT02504671|2962090|Other||Difference|40.5|||||2-Sided|95.0|23.7|57.3|||||Week 62 (follow-up), ACR20. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613606|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 62 (follow-up), ACR20. Difference to Placebo is presented for Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613607|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Week 52, ACR70. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613608|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Week 52, ACR70. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613609|NCT02504671|2962090|Other||Difference|24.3|||||2-Sided|95.0|9.1|39.6|||||Week 52, ACR50. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613610|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613611|NCT02504671|2962090|Other||Difference|48.6|||||2-Sided|95.0|31.7|65.6|||||Week 52, ACR20. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613612|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo is presented for Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613613|NCT02504671|2962090|Other||Difference|21.6|||||2-Sided|95.0|8.4|34.9|||||Week 48, ACR70. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613614|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Week 48, ACR70. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613615|NCT02504671|2962090|Other||Difference|32.4|||||2-Sided|95.0|16.2|48.7|||||Week 48, ACR50. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613616|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 48, ACR50. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613617|NCT02504671|2962090|Other||Difference|51.4|||||2-Sided|95.0|37.3|70.9|||||Week 48, ACR20. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613618|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 48, ACR20. Difference to Placebo is presented for Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613619|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|6.3|31.5|||||Week 44, ACR70. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613620|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Week 44, ACR70. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613621|NCT02504671|2962090|Other||Difference|35.1|||||2-Sided|95.0|18.7|51.6|||||Week 44, ACR50. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613622|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 44, ACR50. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613623|NCT02504671|2962090|Other||Difference|51.4|||||2-Sided|95.0|34.5|68.2|||||Week 44, ACR20. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613624|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 44, ACR20. Difference to Placebo is presented for Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613625|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 40, ACR70. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613626|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-3.2|19.4|||||Week 40, ACR70. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613627|NCT02504671|2962090|Other||Difference|29.7|||||2-Sided|95.0|13.8|45.7|||||Week 40, ACR50. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613628|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 40, ACR50. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613629|NCT02504671|2962090|Other||Difference|51.4|||||2-Sided|95.0|34.5|68.2|||||Week 40, ACR20. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613630|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 40, ACR20. Difference to Placebo is presented for Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613631|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Week 36, ACR70. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613632|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|4.3|28.1|||||Week 36, ACR70. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613633|NCT02504671|2962090|Other||Difference|32.4|||||2-Sided|95.0|16.2|48.7|||||Week 36, ACR50. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613634|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 36, ACR50. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613635|NCT02504671|2962090|Other||Difference|56.8|||||2-Sided|95.0|40.1|73.4|||||Week 36, ACR20. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613636|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 36, ACR20. Difference to Placebo is presented for Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613637|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 32, ACR70. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613638|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 32, ACR70. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613639|NCT02504671|2962090|Other||Difference|27.0|||||2-Sided|95.0|11.4|42.7|||||Week 32, ACR50. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613640|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 32, ACR50. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613641|NCT02504671|2962090|Other||Difference|51.4|||||2-Sided|95.0|34.5|68.2|||||Week 32, ACR20. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613642|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 32, ACR20. Difference to Placebo is presented for Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613643|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613644|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-3.2|19.4|||||Week 28, ACR70. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613645|NCT02504671|2962090|Other||Difference|21.6|||||2-Sided|95.0|6.8|36.4|||||Week 28, ACR50. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613646|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 28, ACR50. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613647|NCT02504671|2962090|Other||Difference|64.9|||||2-Sided|95.0|48.9|80.8|||||Week 28, ACR20. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613648|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 28, ACR20. Difference to Placebo is presented for Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613649|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|-1.1|28.1|||||Week 24, ACR70. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613650|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|-1.1|28.1|||||Week 24, ACR70. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613651|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|-1.2|33.7|||||Week 24, ACR50. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613652|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|-3.6|30.6|||||Week 24, ACR50. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613653|NCT02504671|2962090|Other||Difference|45.9|||||2-Sided|95.0|26.7|65.2|||||Week 24, ACR20. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613654|NCT02504671|2962090|Other||Difference|27.0|||||2-Sided|95.0|7.7|46.3|||||Week 24, ACR20. Difference to Placebo is presented for Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613655|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|-1.1|28.1|||||Week 20, ACR70. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613656|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|3.3|34.5|||||Week 20, ACR70. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613657|NCT02504671|2962090|Other||Difference|21.6|||||2-Sided|95.0|4.5|38.8|||||Week 20, ACR50. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613658|NCT02504671|2962090|Other||Difference|24.3|||||2-Sided|95.0|6.9|41.8|||||Week 20, ACR50. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613659|NCT02504671|2962090|Other||Difference|43.2|||||2-Sided|95.0|23.5|63.0|||||Week 20, ACR20. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613660|NCT02504671|2962090|Other||Difference|21.6|||||2-Sided|95.0|2.0|41.2|||||Week 20, ACR20. Difference to Placebo is presented for Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613661|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-7.0|17.8|||||Week 16, ACR70. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613662|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|-2.4|29.4|||||Week 16, ACR50. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613663|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613664|NCT02504671|2962090|Other||Difference|51.4|||||2-Sided|95.0|32.2|70.5|||||Week 16, ACR20. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613665|NCT02504671|2962090|Other||Difference|24.3|||||2-Sided|95.0|4.5|44.1|||||Week 16, ACR20. Difference to Placebo is presented for Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613666|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-7.0|17.8|||||Week 12, ACR70. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613667|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-8.7|14.1|||||Week 12, ACR70. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613668|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|-2.4|29.4|||||Week 12, ACR50. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613669|NCT02504671|2962090|Other||Difference|21.6|||||2-Sided|95.0|4.5|38.8|||||Week 12, ACR50. Difference to Placebo is presented for Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613670|NCT02504671|2962090|Other||Difference|40.5|||||2-Sided|95.0|21.6|59.5|||||Week 12, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613973|NCT02504671|2962094|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613671|NCT02504671|2962090|Other||Difference|29.7|||||2-Sided|95.0|11.0|48.4|||||Week 12, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613672|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 8, ACR70. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613673|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 8, ACR70. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613674|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 8, ACR50. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613675|NCT02504671|2962090|Other||Difference|21.6|||||2-Sided|95.0|6.8|36.4|||||Week 8, ACR50. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613676|NCT02504671|2962090|Other||Difference|35.1|||||2-Sided|95.0|15.1|55.1|||||Week 8, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613677|NCT02504671|2962090|Other||Difference|32.4|||||2-Sided|95.0|12.4|52.4|||||Week 8, ACR20. Difference to Placebo is presented for Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613678|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Week 6, ACR70. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613679|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613680|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-12.2|17.6|||||Week 6, ACR50. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613681|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-12.2|17.6|||||Week 6, ACR50. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613682|NCT02504671|2962090|Other||Difference|24.3|||||2-Sided|95.0|3.5|45.2|||||Week 6, ACR20. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613683|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|-6.8|33.8|||||Week 6, ACR20. Difference to Placebo is presented for Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613684|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Week 4, ACR70. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613685|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-8.7|14.1|||||Week 4, ACR50. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613686|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-8.7|14.1|||||Week 4, ACR50. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613687|NCT02504671|2962090|Other||Difference|51.4|||||2-Sided|95.0|19.5|56.1|||||Week 4, ACR20. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613688|NCT02504671|2962090|Other||Difference|37.8|||||2-Sided|95.0|19.5|56.1|||||Week 4, ACR20. Difference to Placebo is presented for Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613689|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Week 2, ACR50. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613690|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Week 2, ACR50. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613691|NCT02504671|2962090|Other||Difference|37.8|||||2-Sided|95.0|20.3|55.4|||||Week 2, ACR20. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613692|NCT02504671|2962090|Other||Difference|29.7|||||2-Sided|95.0|12.7|46.8|||||Week 2, ACR20. Difference to Placebo is presented for Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613693|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|6.3|31.5|||||Week 1, ACR20. Difference to Placebo is presented for Week 1. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613694|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Week 1, ACR20. Difference to Placebo is presented for Week 1. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613695|NCT02504671|2962090|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613696|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613697|NCT02504671|2962090|Other||Difference|-2.7|||||2-Sided|95.0|-7.9|2.5|||||Week 62 (follow-up), ACR70. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613698|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613699|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613848|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613700|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||Week 62 (follow-up), ACR50. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613701|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-3.2|19.4|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613702|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613703|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 62 (follow-up), ACR20. Difference to Placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613704|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613705|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|4.3|28.1|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613706|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Week 52, ACR70. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613707|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613708|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613709|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 52, ACR50. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613710|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613711|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613712|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 52, ACR20. Difference to Placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613713|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613714|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|6.3|31.5|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613715|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Week 48, ACR70. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613716|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613717|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613718|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 48, ACR50. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613719|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613720|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613721|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 48, ACR20. Difference to Placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613722|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613723|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|6.3|31.5|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613724|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Week 44, ACR70. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613725|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613726|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613727|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 44, ACR50. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613728|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614087|NCT02504268|2962122|Superiority|||||||0.0112|||||||Regression, Logistic||||
1613729|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613730|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 44, ACR20. Difference to Placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613731|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613732|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613733|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||Week 40, ACR70. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613734|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613735|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613736|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 40, ACR50. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613737|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|4.7|33.2|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613738|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613739|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 40, ACR20. Difference to Placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613740|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613741|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|6.3|31.5|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613742|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Week 36, ACR70. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613743|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-3.2|19.4|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613744|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613745|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||Week 36, ACR50. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613746|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613747|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613748|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 36, ACR20. Difference to Placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613749|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613750|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613751|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||Week 32, ACR70. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613752|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613753|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|4.7|33.2|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613754|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 32, ACR50. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613755|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|4.7|33.2|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613756|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|4.7|33.2|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613757|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 32, ACR20. Difference to Placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613966|NCT02504671|2962094|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613758|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613759|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613760|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 28, ACR70. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613761|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613762|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613763|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 28, ACR50. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613764|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613765|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613766|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 28, ACR20. Difference to Placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613767|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-5.1|21.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613768|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-5.1|21.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613769|NCT02504671|2962090|Other||Difference|0.0|||||2-Sided|95.0|-10.3|10.3|||||Week 24, ACR70. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613770|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|1.1|36.7|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613771|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|-1.2|33.7|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613772|NCT02504671|2962090|Other||Difference|0.0|||||2-Sided|95.0|-14.1|14.1|||||Week 24, ACR50. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613773|NCT02504671|2962090|Other||Difference|43.2|||||2-Sided|95.0|23.8|62.6|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613774|NCT02504671|2962090|Other||Difference|27.0|||||2-Sided|95.0|7.7|46.3|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613775|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-6.9|28.5|||||Week 24, ACR20. Difference to Placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613776|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-5.1|21.3|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613777|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-3.1|24.7|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613778|NCT02504671|2962090|Other||Difference|-2.7|||||2-Sided|95.0|-11.7|6.3|||||Week 20, ACR70. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613779|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|-2.4|29.4|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613780|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|-0.2|32.6|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613781|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-10.6|16.0|||||Week 20, ACR50. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613782|NCT02504671|2962090|Other||Difference|37.8|||||2-Sided|95.0|17.9|57.8|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613783|NCT02504671|2962090|Other||Difference|21.6|||||2-Sided|95.0|2.0|41.2|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613784|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-10.1|26.3|||||Week 20, ACR20. Difference to Placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613785|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|-1.1|28.1|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613786|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-5.1|21.3|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613967|NCT02504671|2962094|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613787|NCT02504671|2962090|Other||Difference|-2.7|||||2-Sided|95.0|-11.7|6.3|||||Week 16, ACR70. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613788|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613789|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|2.1|35.7|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613790|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|-2.4|29.4|||||Week 16, ACR50. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613791|NCT02504671|2962090|Other||Difference|35.1|||||2-Sided|95.0|15.1|55.1|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613792|NCT02504671|2962090|Other||Difference|29.7|||||2-Sided|95.0|9.8|49.7|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613793|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|-5.4|32.4|||||Week 16, ACR20. Difference to Placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613794|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|-1.1|28.1|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613795|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-5.1|21.3|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613796|NCT02504671|2962090|Other||Difference|-2.7|||||2-Sided|95.0|-11.7|6.3|||||Week 12, ACR70. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613797|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|-0.2|32.6|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613798|NCT02504671|2962090|Other||Difference|18.9|||||2-Sided|95.0|2.1|35.7|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613799|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-10.6|16.0|||||Week 12, ACR50. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613800|NCT02504671|2962090|Other||Difference|40.5|||||2-Sided|95.0|21.6|59.5|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613801|NCT02504671|2962090|Other||Difference|29.7|||||2-Sided|95.0|11.0|48.4|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613802|NCT02504671|2962090|Other||Difference|24.3|||||2-Sided|95.0|6.0|42.7|||||Week 12, ACR20. Difference to Placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613803|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-3.2|19.4|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613804|NCT02504671|2962090|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613805|NCT02504671|2962090|Other||Difference|-2.7|||||2-Sided|95.0|-7.9|2.5|||||Week 8, ACR70. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613806|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613807|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613808|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-3.2|19.4|||||Week 8, ACR50. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613809|NCT02504671|2962090|Other||Difference|29.7|||||2-Sided|95.0|9.8|49.7|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613810|NCT02504671|2962090|Other||Difference|24.3|||||2-Sided|95.0|4.5|44.1|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613811|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-10.1|26.3|||||Week 8, ACR20. Difference to Placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613812|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613813|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Week 6, ACR70. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613814|NCT02504671|2962090|Other||Difference|0.0|||||2-Sided|95.0|-14.1|14.1|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613815|NCT02504671|2962090|Other||Difference|-2.7|||||2-Sided|95.0|-16.0|10.6|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613816|NCT02504671|2962090|Other||Difference|-5.4|||||2-Sided|95.0|-17.8|7.0|||||Week 6, ACR50. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613817|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-9.3|30.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613818|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-11.7|27.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613819|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-9.3|30.9|||||Week 6, ACR20. Difference to Placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613820|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Week 4, ACR70. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613821|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-7.0|17.8|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613822|NCT02504671|2962090|Other||Difference|0.0|||||2-Sided|95.0|-10.3|10.3|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613823|NCT02504671|2962090|Other||Difference|0.0|||||2-Sided|95.0|-10.3|10.3|||||Week 4, ACR50. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613824|NCT02504671|2962090|Other||Difference|24.3|||||2-Sided|95.0|6.9|41.8|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613825|NCT02504671|2962090|Other||Difference|27.0|||||2-Sided|95.0|9.3|44.7|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613826|NCT02504671|2962090|Other||Difference|16.2|||||2-Sided|95.0|-0.2|32.6|||||Week 4, ACR20. Difference to Placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613827|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613828|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613829|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Week 2, ACR50. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613830|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|-3.1|24.7|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613831|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-5.1|21.3|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613832|NCT02504671|2962090|Other||Difference|13.5|||||2-Sided|95.0|-1.1|28.1|||||Week 2, ACR20. Difference to Placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613833|NCT02504671|2962090|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Week 1, ACR50. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613834|NCT02504671|2962090|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613835|NCT02504671|2962090|Other||Difference|8.1|||||2-Sided|95.0|-0.7|16.9|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613836|NCT02504671|2962090|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Week 1, ACR20. Difference to Placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613837|NCT02504671|2962091|Other||Difference|51.4|||||2-Sided|95.0|34.5|68.2|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613838|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613839|NCT02504671|2962091|Other||Difference|48.6|||||2-Sided|95.0|31.7|65.6|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613840|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613841|NCT02504671|2962091|Other||Difference|62.2|||||2-Sided|95.0|45.9|78.4|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613842|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613843|NCT02504671|2962091|Other||Difference|56.8|||||2-Sided|95.0|40.1|73.4|||||Difference to placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613844|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Difference to placebo for Week 44 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613845|NCT02504671|2962091|Other||Difference|62.2|||||2-Sided|95.0|45.9|78.4|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613846|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614088|NCT02504268|2962123|Superiority|||||||0.2359|||||||Regression, Logistic||||
1613849|NCT02504671|2962091|Other||Difference|70.3|||||2-Sided|95.0|55.0|85.5|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613850|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613851|NCT02504671|2962091|Other||Difference|75.7|||||2-Sided|95.0|61.4|89.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613852|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613853|NCT02504671|2962091|Other||Difference|54.1|||||2-Sided|95.0|35.1|73.0|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613854|NCT02504671|2962091|Other||Difference|27.0|||||2-Sided|95.0|7.1|46.9|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613855|NCT02504671|2962091|Other||Difference|56.8|||||2-Sided|95.0|38.2|75.4|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613856|NCT02504671|2962091|Other||Difference|27.0|||||2-Sided|95.0|7.1|46.9|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613857|NCT02504671|2962091|Other||Difference|51.4|||||2-Sided|95.0|31.8|70.9|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613858|NCT02504671|2962091|Other||Difference|21.6|||||2-Sided|95.0|0.9|42.4|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613859|NCT02504671|2962091|Other||Difference|54.1|||||2-Sided|95.0|34.9|73.2|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613860|NCT02504671|2962091|Other||Difference|27.0|||||2-Sided|95.0|6.2|47.9|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613861|NCT02504671|2962091|Other||Difference|35.1|||||2-Sided|95.0|13.8|56.5|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613862|NCT02504671|2962091|Other||Difference|27.0|||||2-Sided|95.0|5.2|48.9|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613863|NCT02504671|2962091|Other||Difference|40.5|||||2-Sided|95.0|19.9|61.2|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613864|NCT02504671|2962091|Other||Difference|21.6|||||2-Sided|95.0|0.4|42.8|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613865|NCT02504671|2962091|Other||Difference|51.4|||||2-Sided|95.0|32.2|70.5|||||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613866|NCT02504671|2962091|Other||Difference|27.0|||||2-Sided|95.0|7.1|46.9|||||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613867|NCT02504671|2962091|Other||Difference|24.3|||||2-Sided|95.0|5.2|43.4|||||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613868|NCT02504671|2962091|Other||Difference|18.9|||||2-Sided|95.0|0.2|37.6|||||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613869|NCT02504671|2962091|Other||Difference|21.6|||||2-Sided|95.0|5.6|37.7|||||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613870|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|-1.1|28.1|||||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613871|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613872|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613873|NCT02504671|2962091|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||Difference to placebo for Week 62 (follow-up) is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613874|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613875|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613876|NCT02504671|2962091|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Difference to placebo for Week 52 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613877|NCT02504671|2962091|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613878|NCT02504671|2962091|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613879|NCT02504671|2962091|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Difference to placebo for Week 48 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613968|NCT02504671|2962094|Other||Difference|18.9|||||2-Sided|95.0|6.3|31.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613880|NCT02504671|2962091|Other||Difference|18.9|||||2-Sided|95.0|4.7|33.2|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613881|NCT02504671|2962091|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613882|NCT02504671|2962091|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Difference to placebo for Week 40 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613883|NCT02504671|2962091|Other||Difference|18.9|||||2-Sided|95.0|4.7|33.2|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613884|NCT02504671|2962091|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613885|NCT02504671|2962091|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Difference to placebo for Week 36 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613886|NCT02504671|2962091|Other||Difference|18.9|||||2-Sided|95.0|4.7|33.2|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613887|NCT02504671|2962091|Other||Difference|18.9|||||2-Sided|95.0|4.7|33.2|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613888|NCT02504671|2962091|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Difference to placebo for Week 32 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613889|NCT02504671|2962091|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613890|NCT02504671|2962091|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613891|NCT02504671|2962091|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Difference to placebo for Week 28 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613892|NCT02504671|2962091|Other||Difference|37.8|||||2-Sided|95.0|17.9|57.8|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613893|NCT02504671|2962091|Other||Difference|29.7|||||2-Sided|95.0|9.8|49.7|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613894|NCT02504671|2962091|Other||Difference|16.2|||||2-Sided|95.0|-3.0|35.4|||||Difference to placebo for Week 24 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613895|NCT02504671|2962091|Other||Difference|48.6|||||2-Sided|95.0|29.2|68.1|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613896|NCT02504671|2962091|Other||Difference|35.1|||||2-Sided|95.0|15.1|55.1|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613897|NCT02504671|2962091|Other||Difference|18.9|||||2-Sided|95.0|-0.5|38.4|||||Difference to placebo for Week 20 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613898|NCT02504671|2962091|Other||Difference|37.8|||||2-Sided|95.0|17.2|58.5|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613899|NCT02504671|2962091|Other||Difference|32.4|||||2-Sided|95.0|11.6|53.3|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613900|NCT02504671|2962091|Other||Difference|13.5|||||2-Sided|95.0|-6.8|33.8|||||Difference to placebo for Week 16 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613901|NCT02504671|2962091|Other||Difference|45.9|||||2-Sided|95.0|25.9|66.0|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613902|NCT02504671|2962091|Other||Difference|29.7|||||2-Sided|95.0|8.9|50.6|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613903|NCT02504671|2962091|Other||Difference|21.6|||||2-Sided|95.0|0.9|42.4|||||Difference to placebo for Week 12 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613904|NCT02504671|2962091|Other||Difference|32.4|||||2-Sided|95.0|10.9|54.0|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613905|NCT02504671|2962091|Other||Difference|27.0|||||2-Sided|95.0|5.2|48.9|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613906|NCT02504671|2962091|Other||Difference|10.8|||||2-Sided|95.0|-11.2|32.8|||||Difference to placebo for Week 8 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.Wald confidence limits without correction.||
1613907|NCT02504671|2962091|Other||Difference|27.0|||||2-Sided|95.0|5.8|48.3|||||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613908|NCT02504671|2962091|Other||Difference|18.9||||0.083|2-Sided|95.0|-2.2|40.0|||Regression, Logistic||Difference to placebo for Week 6 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613909|NCT02504671|2962091|Other||Difference|21.6||||0.044|2-Sided|95.0|0.4|42.8|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613910|NCT02504671|2962091|Other||Difference|29.7||||0.008|2-Sided|95.0|9.8|49.7|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613911|NCT02504671|2962091|Other||Difference|21.6||||0.039|2-Sided|95.0|2.0|41.2|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613912|NCT02504671|2962091|Other||Difference|29.7||||0.006|2-Sided|95.0|9.8|49.7|||Regression, Logistic||Difference to placebo for Week 4 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613913|NCT02504671|2962091|Other||Difference|24.3||||0.023|2-Sided|95.0|5.2|43.4|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613914|NCT02504671|2962091|Other||Difference|2.7||||0.755|2-Sided|95.0|-13.5|18.9|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613915|NCT02504671|2962091|Other||Difference|5.4||||0.437|2-Sided|95.0|-11.3|22.2|||Regression, Logistic||Difference to placebo for Week 2 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613916|NCT02504671|2962091|Other||Difference|18.9||||0.033|2-Sided|95.0|3.3|34.5|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613917|NCT02504671|2962091|Other||Difference|10.8||||0.144|2-Sided|95.0|-3.1|24.7|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613918|NCT02504671|2962091|Other||Difference|16.2||||0.037|2-Sided|95.0|1.1|31.4|||Regression, Logistic||Difference to placebo for Week 1 is presented. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613919|NCT02504671|2962093|Other||Mean Difference (Net)|-1.82|||<|0.001|2-Sided|95.0|-2.75|-0.89||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24||
1613920|NCT02504671|2962093|Other||Mean Difference (Net)|-1.48|||<|0.003|2-Sided|95.0|-2.46|-0.5||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24||
1613921|NCT02504671|2962093|Other||Mean Difference (Net)|-0.8|||<|0.059|2-Sided|95.0|-1.63|0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20||
1613922|NCT02504671|2962093|Other||Mean Difference (Net)|-0.77|||<|0.083|2-Sided|95.0|-1.65|0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20||
1613923|NCT02504671|2962093|Other||Mean Difference (Net)|-1.11|||<|0.007|2-Sided|95.0|-1.91|-0.3||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16||
1613924|NCT02504671|2962093|Other||Mean Difference (Net)|-0.77|||<|0.073|2-Sided|95.0|-1.61|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16||
1613925|NCT02504671|2962093|Other||Mean Difference (Net)|-1.27|||<|0.001|2-Sided|95.0|-1.91|-0.63||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12||
1613926|NCT02504671|2962093|Other||Mean Difference (Net)|-0.68|||<|0.039|2-Sided|95.0|-1.32|-0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12||
1613927|NCT02504671|2962093|Other||Mean Difference (Net)|-1.1|||<|0.001|2-Sided|95.0|-1.65|-0.56||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8||
1613928|NCT02504671|2962093|Other||Mean Difference (Net)|-0.89|||<|0.001|2-Sided|95.0|-1.43|-0.35||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8||
1613929|NCT02504671|2962093|Other||Mean Difference (Net)|-0.85|||<|0.001|2-Sided|95.0|-1.36|-0.34||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6||
1613930|NCT02504671|2962093|Other||Mean Difference (Net)|-0.47|||<|0.073|2-Sided|95.0|-0.99|0.04||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6||
1613931|NCT02504671|2962093|Other||Mean Difference (Net)|-1.01|||<|0.001|2-Sided|95.0|-1.48|-0.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4||
1613932|NCT02504671|2962093|Other||Mean Difference (Net)|-0.67|||<|0.005|2-Sided|95.0|-1.13|-0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4||
1613933|NCT02504671|2962093|Other||Mean Difference (Net)|-0.52|||<|0.009|2-Sided|95.0|-0.9|-0.13||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2||
1613934|NCT02504671|2962093|Other||Mean Difference (Net)|-0.47|||<|0.017|2-Sided|95.0|-0.86|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2||
1613935|NCT02504671|2962093|Other||Mean Difference (Net)|-0.49|||<|0.003|2-Sided|95.0|-0.8|-0.17||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1||
1613936|NCT02504671|2962093|Other||Mean Difference (Net)|-0.41|||<|0.013|2-Sided|95.0|-0.73|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1||
1613937|NCT02504671|2962093|Other||Mean Difference (Net)|-1.39|||<|0.005|2-Sided|95.0|-2.34|-0.43||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24||
1613969|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613938|NCT02504671|2962093|Other||Mean Difference (Net)|-1.53|||<|0.002|2-Sided|95.0|-2.51|-0.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24||
1613939|NCT02504671|2962093|Other||Mean Difference (Net)|-1.22|||<|0.019|2-Sided|95.0|-2.24|-0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 24||
1613940|NCT02504671|2962093|Other||Mean Difference (Net)|-0.66|||<|0.13|2-Sided|95.0|-1.51|0.2||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20||
1613941|NCT02504671|2962093|Other||Mean Difference (Net)|-0.58|||<|0.19|2-Sided|95.0|-1.46|0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20||
1613942|NCT02504671|2962093|Other||Mean Difference (Net)|-0.07|||<|0.871|2-Sided|95.0|-0.98|0.83||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 20||
1613943|NCT02504671|2962093|Other||Mean Difference (Net)|-1.0|||<|0.017|2-Sided|95.0|-1.83|-0.18||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16||
1613944|NCT02504671|2962093|Other||Mean Difference (Net)|-0.99|||<|0.021|2-Sided|95.0|-1.83|-0.15||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16||
1613945|NCT02504671|2962093|Other||Mean Difference (Net)|-0.29|||<|0.5|2-Sided|95.0|-1.15|0.56||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 16||
1613946|NCT02504671|2962093|Other||Mean Difference (Net)|-1.24|||<|0.001|2-Sided|95.0|-1.88|-0.6||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12||
1613947|NCT02504671|2962093|Other||Mean Difference (Net)|-0.88|||<|0.008|2-Sided|95.0|-1.53|-0.23||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12||
1613948|NCT02504671|2962093|Other||Mean Difference (Net)|-0.53|||<|0.11|2-Sided|95.0|-1.17|0.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 12||
1613949|NCT02504671|2962093|Other||Mean Difference (Net)|-0.82|||<|0.003|2-Sided|95.0|-1.36|-0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8||
1613950|NCT02504671|2962093|Other||Mean Difference (Net)|-0.78|||<|0.005|2-Sided|95.0|-1.33|-0.24||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8||
1613951|NCT02504671|2962093|Other||Mean Difference (Net)|-0.42|||<|0.128|2-Sided|95.0|-0.97|0.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 8||
1613952|NCT02504671|2962093|Other||Mean Difference (Net)|-0.61|||<|0.02|2-Sided|95.0|-1.11|-0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6||
1613953|NCT02504671|2962093|Other||Mean Difference (Net)|-0.47|||<|0.076|2-Sided|95.0|-0.98|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6||
1613954|NCT02504671|2962093|Other||Mean Difference (Net)|-0.42|||<|0.11|2-Sided|95.0|-0.93|0.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 6||
1613955|NCT02504671|2962093|Other||Mean Difference (Net)|-0.76|||<|0.001|2-Sided|95.0|-1.22|-0.29||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4||
1613956|NCT02504671|2962093|Other||Mean Difference (Net)|-0.56|||<|0.02|2-Sided|95.0|-1.02|-0.09||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4||
1613957|NCT02504671|2962093|Other||Mean Difference (Net)|-0.4|||<|0.096|2-Sided|95.0|-0.87|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 4||
1613958|NCT02504671|2962093|Other||Mean Difference (Net)|-0.42|||<|0.034|2-Sided|95.0|-0.8|-0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2||
1613959|NCT02504671|2962093|Other||Mean Difference (Net)|-0.32|||<|0.103|2-Sided|95.0|-0.71|0.07||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2||
1613960|NCT02504671|2962093|Other||Mean Difference (Net)|-0.28|||<|0.16|2-Sided|95.0|-0.67|0.11||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 2||
1613961|NCT02504671|2962093|Other||Mean Difference (Net)|-0.37|||<|0.022|2-Sided|95.0|-0.69|-0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1||
1613962|NCT02504671|2962093|Other||Mean Difference (Net)|-0.3|||<|0.071|2-Sided|95.0|-0.62|0.03||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1||
1613963|NCT02504671|2962093|Other||Mean Difference (Net)|-0.32|||<|0.046|2-Sided|95.0|-0.64|-0.01||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||Week 1||
1613964|NCT02504671|2962094|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613965|NCT02504671|2962094|Other||Difference|8.1|||||2-Sided|95.0|-3.2|19.4|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613974|NCT02504671|2962094|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 36, 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613975|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613976|NCT02504671|2962094|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613977|NCT02504671|2962094|Other||Difference|8.1|||||2-Sided|95.0|-3.2|19.4|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613978|NCT02504671|2962094|Other||Difference|18.9|||||2-Sided|95.0|4.7|33.2|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613979|NCT02504671|2962094|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613980|NCT02504671|2962094|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613981|NCT02504671|2962094|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613982|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613983|NCT02504671|2962094|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613984|NCT02504671|2962094|Other||Difference|18.9|||||2-Sided|95.0|6.3|31.5|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613985|NCT02504671|2962094|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613986|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613987|NCT02504671|2962094|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613988|NCT02504671|2962094|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613989|NCT02504671|2962094|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613990|NCT02504671|2962094|Other||Difference|2.7|||||2-Sided|95.0|-8.7|14.1|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613991|NCT02504671|2962094|Other||Difference|-2.7|||||2-Sided|95.0|-11.7|6.3|||||95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613992|NCT02504671|2962094|Other||Difference|10.8|||||2-Sided|95.0|0.8|20.8|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613993|NCT02504671|2962094|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613994|NCT02504671|2962094|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613995|NCT02504671|2962094|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613996|NCT02504671|2962094|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613997|NCT02504671|2962094|Other||Difference|-2.7|||||2-Sided|95.0|-7.9|2.5|||||Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613998|NCT02504671|2962094|Other||Difference|8.1|||||2-Sided|95.0|-3.2|19.4|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1613999|NCT02504671|2962094|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614000|NCT02504671|2962094|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614001|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614002|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614003|NCT02504671|2962094|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614004|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614005|NCT02504671|2962094|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614006|NCT02504671|2962094|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614007|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614008|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614009|NCT02504671|2962094|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614010|NCT02504671|2962094|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614011|NCT02504671|2962094|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614012|NCT02504671|2962094|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614013|NCT02504671|2962094|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614014|NCT02504671|2962094|Other||Difference|18.9|||||2-Sided|95.0|4.7|33.2|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614015|NCT02504671|2962094|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614016|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614017|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614018|NCT02504671|2962094|Other||Difference|0.0|||||2-Sided|95.0|-7.4|7.4|||||Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614019|NCT02504671|2962094|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614020|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614021|NCT02504671|2962094|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614022|NCT02504671|2962094|Other||Difference|16.2|||||2-Sided|95.0|2.6|29.9|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614023|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|0.5|26.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614024|NCT02504671|2962094|Other||Difference|-2.7|||||2-Sided|95.0|-7.9|2.5|||||Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614025|NCT02504671|2962094|Other||Difference|27.0|||||2-Sided|95.0|12.7|41.3|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614026|NCT02504671|2962094|Other||Difference|13.5|||||2-Sided|95.0|2.5|24.5|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614027|NCT02504671|2962094|Other||Difference|2.7|||||2-Sided|95.0|-2.5|7.9|||||Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614028|NCT02504671|2962094|Other||Difference|21.6|||||2-Sided|95.0|6.8|36.4|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614029|NCT02504671|2962094|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614030|NCT02504671|2962094|Other||Difference|5.4|||||2-Sided|95.0|-4.8|15.6|||||Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614031|NCT02504671|2962094|Other||Difference|10.8|||||2-Sided|95.0|-1.4|23.0|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614032|NCT02504671|2962094|Other||Difference|2.7|||||2-Sided|95.0|-6.3|11.7|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614033|NCT02504671|2962094|Other||Difference|-2.7|||||2-Sided|95.0|-7.9|2.5|||||Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614034|NCT02504671|2962094|Other||Difference|0.0|||||2-Sided|95.0|-10.3|10.3|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614035|NCT02504671|2962094|Other||Difference|-5.4|||||2-Sided|95.0|-12.7|1.9|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614036|NCT02504671|2962094|Other||Difference|0.0|||||2-Sided|95.0|-10.3|10.3|||||Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614037|NCT02504671|2962094|Other||Difference|5.4|||||2-Sided|95.0|-1.9|12.7|||||Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614038|NCT02504671|2962095|Other||Mean Difference (Net)|-6.32|||<|0.001|2-Sided|95.0|-9.61|-3.02||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12||
1614039|NCT02504671|2962095|Other||Mean Difference (Net)|-3.63|||<|0.031|2-Sided|95.0|-6.92|-0.33||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12||
1614040|NCT02504671|2962095|Other||Mean Difference (Net)|-6.04|||<|0.001|2-Sided|95.0|-9.05|-3.02||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12||
1614041|NCT02504671|2962095|Other||Mean Difference (Net)|-2.98|||<|0.054|2-Sided|95.0|-6.0|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12||
1614042|NCT02504671|2962095|Other||Mean Difference (Net)|-17.18|||<|0.001|2-Sided|95.0|-27.27|-7.1||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12||
1614043|NCT02504671|2962095|Other||Mean Difference (Net)|-12.63|||<|0.015|2-Sided|95.0|-22.78|-2.48||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12||
1614044|NCT02504671|2962095|Other||Mean Difference (Net)|-2.0|||<|0.599|2-Sided|95.0|-9.5|5.49||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12||
1614045|NCT02504671|2962095|Other||Mean Difference (Net)|-2.51|||<|0.518|2-Sided|95.0|-10.13|5.12||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12||
1614111|NCT02503202|2962188|Other||Risk Difference (RD)|0.0||||0.983|2-Sided|95.0|-4.2|4.1|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Arthralgia|
1614046|NCT02504671|2962095|Other||Mean Difference (Net)|-5.72|||<|0.001|2-Sided|95.0|-8.98|-2.45||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12||
1614047|NCT02504671|2962095|Other||Mean Difference (Net)|-3.92|||<|0.02|2-Sided|95.0|-7.22|-0.62||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TJC28, Week 12||
1614048|NCT02504671|2962095|Other||Mean Difference (Net)|-2.3|||<|0.172|2-Sided|95.0|-5.61|1.01||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||TC28, Week 12||
1614049|NCT02504671|2962095|Other||Mean Difference (Net)|-4.56|||<|0.003|2-Sided|95.0|-6.0|0.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12||
1614050|NCT02504671|2962095|Other||Mean Difference (Net)|-3.17|||<|0.041|2-Sided|95.0|-6.2|-0.14||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12||
1614051|NCT02504671|2962095|Other||Mean Difference (Net)|-2.42|||<|0.118|2-Sided|95.0|-5.45|0.62||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||SJC28, Week 12||
1614052|NCT02504671|2962095|Other||Mean Difference (Net)|-17.4|||<|0.001|2-Sided|95.0|-27.44|-7.35||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12||
1614053|NCT02504671|2962095|Other||Mean Difference (Net)|-13.68|||<|0.009|2-Sided|95.0|-23.85|-3.52||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12||
1614054|NCT02504671|2962095|Other||Mean Difference (Net)|-7.68|||<|0.14|2-Sided|95.0|-17.92|2.55||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||PtGA, Week 12||
1614055|NCT02504671|2962095|Other||Mean Difference (Net)|-2.58|||<|0.495|2-Sided|95.0|-10.04|4.87||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12||
1614056|NCT02504671|2962095|Other||Mean Difference (Net)|-3.36|||<|0.387|2-Sided|95.0|-11.0|4.28||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|MMRM||CRP, Week 12||
1614057|NCT02504671|2962095|Other||Mean Difference (Net)|0.46|||<|0.905|2-Sided|95.0|-7.13|8.05||MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.|Mixed Model Repeated Measures (MMRM)||CRP, Week 12||
1614058|NCT02504671|2962096|Other||Odds Ratio (OR)|5.4||||0.134|2-Sided|95.0|0.6|48.83|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614059|NCT02504671|2962096|Other||Odds Ratio (OR)|5.69||||0.122|2-Sided|95.0|0.63|51.4|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614060|NCT02504671|2962096|Other||Odds Ratio (OR)|8.39||||0.053|2-Sided|95.0|0.98|72.14|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614061|NCT02504671|2962096|Other||Odds Ratio (OR)|7.11||||0.077|2-Sided|95.0|0.81|62.44|||Regression, Logistic||95% CI were constructed using asymptotic Wald confidence limits without correction.||
1614062|NCT02504671|2962096|Other||Odds Ratio (OR)|2.12||||0.547|2-Sided|95.0|0.18|24.52|||Regression, Logistic||95% Confidence Intervals (CI) were constructed using asymptotic Wald confidence limits without correction.||
1614063|NCT02504645|2962098|Superiority|||||||0.2631|||||||Chi-squared||||
1614064|NCT02504554|2962102|Other|||||||0.002||||||no adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank test was used to compare scores at baseline vs. at 10 weeks (end of treatment)|
1614065|NCT02504554|2962103|Other||||||<|0.001||||||"no adjustment for multiple comparisons~the p-value listed is the actual result for the analysis of the study data"|t-test, 2 sided|||2-sided t-test comparing the group at baseline vs. 18 weeks (8 weeks after end of treatment)|
1614066|NCT02504554|2962105|Other||||||<|0.001||||||"no adjustment for multiple comparisons~the p-value listed is the actual result for the study results."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test comparing scores at baseline vs. 10 weeks (end of treatment)|
1614067|NCT02504554|2962106|Other||||||<|0.001||||||"no adjustment for multiple comparisons~The p-value listed is the result for the actual analysis of the data."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed-rank test comparing the baseline score vs. the score at 10 weeks (end of treatment).|
1614068|NCT02504554|2962108|Other|paired 2-sided t-test comparing baseline and 10 weeks (end of treatment)|||||<|0.001||||||no adjustment for multiple comparisons|t-test, 2 sided|paired t-test, 2 sided|||
1614069|NCT02504554|2962109|Other||||||<|0.001||||||"no adjustment for multiple hypothesis testing since this was an exploratory study.~the p-value listed is the actual result from analysis of the study data."|Wilcoxon (Mann-Whitney)|||Wilcoxon signed rank analysis of symptoms at 10 weeks (end of treatment) vs. baseline|
1614070|NCT02504424|2962112|Other||% breasts successfully exchanged|95.2|||||1-Sided|||||||||Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in analysis as subject withdrew from the study prior to exchange of her expanders.|
1614071|NCT02504424|2962113|Other||% breasts successfully exchanged|100.0|||||1-Sided|||||||||Sensitivity Analysis (Best / Worst Case): Treatment Success by subject for the Per Protocol cohort includes all failures (excluding non-device related failures). The best case analysis considers success if the subject has at least one breast successfully reconstructed, and the worst case analysis considers it a failure if at least one breast has failed. The treatment success by subject is 100% for both best and worst case analysis.|
1614112|NCT02503202|2962189|Other||Risk Difference (RD)|31.4|||<|0.001|2-Sided|95.0|25.6|37.5|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo||
1615072|NCT02473471|2964573|Other|||||||0.48|||||||t-test, 2 sided|||Root length at 3 months|
1614072|NCT02504424|2962113|Other||percent of breasts successfully exchange|100.0|||||1-Sided|||||||||Treatment Success includes all breasts which were exchanged successfully in the Per Protocol Cohort, excluding non-device related failures. The Treatment Success Rate per breast is 100% (80/80). Note: Denominator = 80 (86 implanted breasts – 6 breasts). Failed exchange = 4 breasts (non-device related) & Missing = 2 breasts (patient non-compliant w/study and withdrew consent after treatment).|
1614073|NCT02504320|2962114|Non-Inferiority or Equivalence|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimates|0.9463|||||2-Sided|90.0|0.8909|1.0051|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and reference (Regimen D).|
1614074|NCT02504320|2962114|Non-Inferiority or Equivalence|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.9056|||||2-Sided|90.0|0.8516|0.963|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).|
1614075|NCT02504320|2962114|Non-Inferiority or Equivalence|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0283|||||2-Sided|90.0|0.9691|1.0911|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).|
1614076|NCT02504320|2962115|Non-Inferiority or Equivalence|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.954|||||2-Sided|90.0|0.8996|1.0117|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).|
1614077|NCT02504320|2962115|Non-Inferiority or Equivalence|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.8777|||||2-Sided|90.0|0.8274|0.9311|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).|
1614078|NCT02504320|2962115|Non-Inferiority or Equivalence|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0435|||||2-Sided|90.0|0.984|1.1066|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).|
1614079|NCT02504320|2962116|Non-Inferiority or Equivalence|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.9389|||||2-Sided|90.0|0.8246|1.0689|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen C) and reference (Regimen D).|
1614080|NCT02504320|2962116|Non-Inferiority or Equivalence|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|0.7709|||||2-Sided|90.0|0.6767|0.8782|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen B) and reference (Regimen D).|
1614081|NCT02504320|2962116|Non-Inferiority or Equivalence|Bioequivalence of Febuxostat formulation 1, 2, and 3 to Febuxostat formulation 4 was declared if the 90% confidence intervals for the ratios of central values were within the pre-specified interval of 0.80 to 1.25.|Point Estimate|1.0848|||||2-Sided|90.0|0.9528|1.235|||||Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural log (ln)-transformed parameters was performed with regimen, sequence, period, and participants nested within sequence as fixed effects.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in test (Regimen A) and reference (Regimen D).|
1614082|NCT02504294|2962117|Superiority or Other||LS Mean Difference|-1062.0|Standard Error of the Mean|803.95||0.1874|2-Sided|95.0|-2643.2|519.2|||ANCOVA|||P-value was calculated using analysis of covariance (ANCOVA) model with treatment as factor and baseline ESA dose as covariate.|
1614083|NCT02504294|2962118|Non-Inferiority or Equivalence|Non-inferiority was concluded since the lower bound of the 95% CI of the difference in percentage was greater than the non-inferiority margin (-12.5%).|Difference in Percentage|-1.3975|||||2-Sided|95.0|-7.6503|4.8553||||||Clustered binomial analysis using logistic regression method was performed and generalized estimating equation method was used to construct 95 percent (%) two-sided confidence intervals (CIs).|
1614084|NCT02504268|2962119|Superiority|||||||0.0006|||||||Regression, Logistic||||
1614085|NCT02504268|2962120|Superiority||||||<|0.0001|||||||rank-based ANCOVA||||
1614086|NCT02504268|2962121|Superiority|||||||0.0021|||||||Regression, Logistic||||
1614089|NCT02503852|2962139|Other|||||||0.0318||||||P value cited is the difference in non-vellus hair count between the low-dose ADRC NW3 group and the no-fat saline control at week 24|ANCOVA|||Non-vellus hair count in the low-dose ADRC group in the NW3 subgroup beginning at Week 6 (mean change from baseline persisting through weeks 12 , 24, and 52.|
1614090|NCT02503852|2962139|Superiority|||||||0.032|||||||ANCOVA||||
1614091|NCT02503787|2962144|Superiority||||||<|0.01|||||||t-test, 2 sided|||A negative value for change in pain represents a reduction (improvement) of the subject's pain score. The null hypothesis was that the mean change from baseline to 3 months equals 0. The sample provided over 90% power, with two-sided significance level of 0.05, to detect a change of 2 points.|
1614092|NCT02503254|2962179|Superiority or Other (legacy)||Geometric LS Mean Ratio|58.83|||<|0.001|2-Sided|95.0|49.3|66.56||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC respectively."|
1614093|NCT02503254|2962180|Superiority or Other (legacy)||Geometric LS Mean Reduction|88.14|||<|0.001|2-Sided|95.0|86.46|89.62||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively."|
1614094|NCT02503254|2962181|Superiority or Other (legacy)||Geometric LS Mean Reduction|63.53|||<|0.001|2-Sided|95.0|59.55|67.12||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively"|
1614095|NCT02503254|2962182|Superiority or Other (legacy)||Geometric LS Mean Reduction|82.82|||<|0.001|2-Sided|95.0|78.79|86.09||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at a two-sided alpha level of 5%.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|"Geometric LS Mean Reduction = 100 - (CHTP 1.0 : CC ratio)~Expressed as %"|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for CHTP 1.0 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for CHTP 1.0 and CC, respectively."|
1614096|NCT02503202|2962186|Other||Risk Difference (RD)|1.5||||0.151|2-Sided|95.0|-1.3|3.9|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo||
1614097|NCT02503202|2962186|Other||Risk Difference (RD)|-0.4||||0.704|2-Sided|95.0|-2.8|2.0|||Miettinen & Nurminen||Risk difference is Lot B - Lot C||
1614098|NCT02503202|2962186|Other||Risk Difference (RD)|0.4||||0.746|2-Sided|95.0|-2.2|3.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C||
1614099|NCT02503202|2962186|Other||Risk Difference (RD)|0.7||||0.483|2-Sided|95.0|-1.6|3.3|||Miettinen & Nurminen||Risk difference is Lot A - Lot B||
1614100|NCT02503202|2962187|Other||Risk Difference (RD)|2.3||||0.202|2-Sided|95.0|-1.8|5.7|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo||
1614101|NCT02503202|2962187|Other||Risk Difference (RD)|0.8||||0.663|2-Sided|95.0|-2.9|4.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C||
1614102|NCT02503202|2962187|Other||Risk Difference (RD)|-0.8||||0.62|2-Sided|95.0|-4.2|2.5|||Miettinen & Nurminen||Risk difference is Lot A - Lot C||
1614103|NCT02503202|2962187|Other||Risk Difference (RD)|-1.5||||0.353|2-Sided|95.0|-5.1|1.9|||Miettinen & Nurminen||Risk difference is Lot A - Lot B||
1614104|NCT02503202|2962188|Other||Risk Difference (RD)|3.1||||0.041|2-Sided|95.0|0.2|6.0|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Arthritis|
1614105|NCT02503202|2962188|Other||Risk Difference (RD)|1.1||||0.46|2-Sided|95.0|-2.1|4.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Arthritis|
1614106|NCT02503202|2962188|Other||Risk Difference (RD)|1.9||||0.25|2-Sided|95.0|-1.4|5.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Arthritis|
1614107|NCT02503202|2962188|Other||Risk Difference (RD)|0.7||||0.677|2-Sided|95.0|-2.9|4.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Arthritis|
1614108|NCT02503202|2962188|Other||Risk Difference (RD)|6.2||||0.012|2-Sided|95.0|1.8|10.4|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Arthralgia|
1614109|NCT02503202|2962188|Other||Risk Difference (RD)|-0.8||||0.716|2-Sided|95.0|-5.1|3.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Arthralgia|
1614110|NCT02503202|2962188|Other||Risk Difference (RD)|-0.8||||0.699|2-Sided|95.0|-5.1|3.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Arthralgia|
1614116|NCT02503202|2962190|Other||Risk Difference (RD)|13.1|||<|0.001|2-Sided|95.0|7.4|18.6|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site swelling|
1614117|NCT02503202|2962190|Other||Risk Difference (RD)|-4.6|||<|0.154|2-Sided|95.0|-10.9|1.7|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site swelling|
1614118|NCT02503202|2962190|Other||Risk Difference (RD)|-0.5|||<|0.878|2-Sided|95.0|-7.1|6.1|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site swelling|
1614119|NCT02503202|2962190|Other||Risk Difference (RD)|4.0|||<|0.202|2-Sided|95.0|-2.2|10.3|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site swelling|
1614120|NCT02503202|2962190|Other||Risk Difference (RD)|54.9|||<|0.001|2-Sided|95.0|46.2|62.3|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site pain|
1614121|NCT02503202|2962190|Other||Risk Difference (RD)|2.7|||<|0.499|2-Sided|95.0|-5.1|10.4|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site pain|
1614122|NCT02503202|2962190|Other||Risk Difference (RD)|-3.5|||<|0.38|2-Sided|94.0|-11.4|4.4|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site pain|
1614123|NCT02503202|2962190|Other||Risk Difference (RD)|-6.2|||<|0.12|2-Sided|95.0|-14.0|1.6|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site pain|
1614124|NCT02503202|2962190|Other||Risk Difference (RD)|5.8|||<|0.016|2-Sided|95.0|1.4|9.9|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo|Injection site erythema|
1614125|NCT02503202|2962190|Other||Risk Difference (RD)|-4.2|||<|0.151|2-Sided|95.0|-10.0|1.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C|Injection site erythema|
1614126|NCT02503202|2962190|Other||Risk Difference (RD)|-0.1|||<|0.971|2-Sided|95.0|-6.2|6.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C|Injection site erythema|
1614127|NCT02503202|2962190|Other||Risk Difference (RD)|4.1|||<|0.16|2-Sided|95.0|-1.6|9.9|||Miettinen & Nurminen||Risk difference is Lot A - Lot B|Injection site erythema|
1614128|NCT02503202|2962191|Other||Risk Difference (RD)|1.2||||0.214|2-Sided|95.0|-1.7|3.3|||Miettinen & Nurminen||Risk difference is High-dose Lot - Placebo||
1614129|NCT02503202|2962191|Other||Risk Difference (RD)|-1.1||||0.361|2-Sided|95.0|-4.1|1.5|||Miettinen & Nurminen||Risk difference is Lot B - Lot C||
1614130|NCT02503202|2962191|Other||Risk Difference (RD)|0.0||||0.989|2-Sided|95.0|-3.1|3.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot C||
1614131|NCT02503202|2962191|Other||Risk Difference (RD)|1.1||||0.368|2-Sided|95.0|-1.5|4.0|||Miettinen & Nurminen||Risk difference is Lot A - Lot B||
1614132|NCT02503202|2962192|Equivalence|Lot consistency requires the 95% confidence interval of the GMT ratio of >0.5 and ≤2.0 for the primary analysis and >0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot B / Lot C)|0.94|||<|0.001|2-Sided|95.0|0.77|1.15||Primary analysis: a p-value <0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA||||
1614133|NCT02503202|2962192|Equivalence|Lot consistency requires the 95% confidence interval of the GMT ratio of >0.5 and ≤2.0 for the primary analysis and >0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot A / Lot C)|0.88|||<|0.001|2-Sided|95.0|0.71|1.09||Primary analysis: a p-value <0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA||||
1614134|NCT02503202|2962192|Equivalence|Lot consistency requires the 95% confidence interval of the GMT ratio of >0.5 and ≤2.0 for the primary analysis and >0.67 and ≤1.5 for the secondary analysis.|GMT ratio (Lot A / Lot B)|0.94|||<|0.001|2-Sided|95.0|0.77|1.14||Primary analysis: a p-value <0.025 supported the conclusion of equivalence. If equivalence was established for the 3 pairwise comparisons, the lots would be considered to be consistent.|ANOVA||||
1614135|NCT02502734|2962209|Non-Inferiority or Equivalence|Non-inferiority would be demonstrated if the lower limit of the confidence interval (0.025, 1-sided significance test level) for the mean difference in lower-leg growth rate of FF 50 mcg OD versus Placebo was greater than -0.20mm/week.|Mean Difference (Final Values)|-0.052|||||2-Sided|95.0|-0.1217|0.0176|||||||
1614136|NCT02502526|2962210|Superiority|||||||0.817|||||||ANCOVA||||
1614137|NCT02502526|2962210|Superiority|||||||0.52|||||||ANCOVA||||
1614138|NCT02502526|2962211|Superiority|||||||0.605|||||||ANCOVA||||
1614139|NCT02502526|2962211|Superiority||||||<|0.001|||||||ANCOVA||||
1614140|NCT02502526|2962212|Superiority||||||<|0.001|||||||ANCOVA||||
1614141|NCT02502461|2962235|Superiority||Mean Difference (Final Values)|0.9||||0.04|2-Sided|95.0|0.1|1.7||Bonferroni correction|t-test, 2 sided||||
1614142|NCT02502149|2962293|Other||Adjusted Geometric Mean Ratio|1.01|||||2-Sided|90.0|0.87|1.16|||||The adjusted geometric mean ratio is calculated as 15K (PK2)/2K (PK1).||
1614143|NCT02502149|2962294|Other||Adjusted Geometric Mean Ratio|1.08|||||2-Sided|90.0|0.93|1.24|||||The adjusted geometric mean ratio is calculated as 15K (PK2)/2K (PK1).||
1614144|NCT02501629|2962307|Superiority||Odds Ratio (OR)|0.82||||0.628|2-Sided|95.0|0.371|1.818||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.|
1614145|NCT02501629|2962308|Superiority||CAE rate ratio|0.82||||0.407|2-Sided|95.0|0.504|1.321|||Negative binomial regression model|Negative binomial regression model adjusted for stratification factors (OCS dose group), age, number of prior exacerbations, and an offset variable.|reslizumab vs placebo||
1614182|NCT02499900|2962496|Superiority||Mean Difference (Final Values)|-0.231||||0.47|2-Sided|95.0|-0.8588|0.3962||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Physical Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.|
1614338|NCT02494401|2963015|Superiority|||||||0.08||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)||||
1614146|NCT02501629|2962309|Superiority||Odds Ratio (OR)|1.36||||0.341|2-Sided|95.0|0.722|2.562||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.|
1614147|NCT02501629|2962310|Superiority||Mean Difference (Final Values)|-17.75|Standard Error of the Mean|10.759||0.101|2-Sided|95.0|-38.986|3.494|||mixed model repeated measures (MMRM)||Reslizumab - Placebo|Mixed model repeated measures (MMRM) with fixed effects for treatment, visit, treatment by visit interaction, age group, and OCS dose group, duration of OCS use and baseline value as covariates, and patient as a random effect. Unstructured covariance was assumed for the repeated measures.|
1614148|NCT02501629|2962311|Superiority||Odds Ratio (OR)|1.19||||0.596|2-Sided|95.0|0.631|2.229||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.|
1614149|NCT02501629|2962312|Superiority||Odds Ratio (OR)|1.45||||0.234|2-Sided|95.0|0.786|2.683||significance at 0.05.|Regression, Logistic|logistic regression model adjusted for treatment, stratification factors (age group and OCS dose group), duration of OCS use, and baseline value.||As the analysis of the primary efficacy endpoint did not meet criteria for statistical significance (p≤0.05), the secondary efficacy endpoints were not interpreted inferentially according to the pre-defined hierarchy. P-values are nominal, meaning they were obtained from the analysis without adjustments to protect family-wise errors and should be interpreted with caution. Nominal p-values do not indicate treatment differences.|
1614150|NCT02501629|2962313|Superiority||Odds Ratio (OR)|1.23||||0.468|2-Sided|95.0|0.702|2.157||Significance at 0.05.|proportional odds model|factors for treatment group and randomization strata (age and OCS dose); baseline OCS dose and duration of OCS use prior to study were covariates.||The proportional odds ratio (reslizumab/placebo) was estimated from this model, representing the ratio of the odds of a patient outcome being in a higher OCS dose reduction category for reslizumab compared to placebo.|
1614151|NCT02501590|2962314|Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1614152|NCT02501161|2962367|Other||||||<|0.0001|||||||Stratified log-rank test|||Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.|
1614153|NCT02501161|2962368|Other||||||<|0.0001|||||||Stratified log-rank test|||Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model.|
1614154|NCT02500979|2962380|Superiority or Other||LS mean ratio (pramlintide/placebo)|1.085||||0.373|2-Sided|95.0|0.901|1.307|||Linear mixed effects model||||
1614155|NCT02500979|2962382|Superiority or Other||LS mean ratio (pramlintide/placebo)|0.951||||0.1015|2-Sided|95.0|0.896|1.011|||Linear mixed-effects model||||
1614156|NCT02500979|2962383|Superiority or Other||LS Mean Ratio (Pramlintide/Placebo)|1.31||||0.0456|2-Sided|95.0|1.01|1.7|||Linear mixed-effects model||||
1614157|NCT02500979|2962385|Superiority or Other||LS mean difference|-28.418||||0.0258|2-Sided|95.0|-53.099|-3.737|||Linear mixed-effects model||||
1614158|NCT02500979|2962386|Superiority or Other||Least squares mean difference|-28733.0|Standard Error of the Mean|4163.6|<|0.0001|2-Sided|95.0|-37326.0|-20139.0|||Linear mixed-effects model||||
1614159|NCT02500979|2962387|Superiority or Other||LS mean difference (pramlintide-placebo)|-4.435||||0.0057|2-Sided|95.0|-7.445|-1.424|||Linear mixed effects model||||
1614160|NCT02500979|2962388|Superiority or Other||LS mean difference (pramlintide-placebo)|-5.277||||0.0091|2-Sided|95.0|-9.175|-1.378|||Linear mixed effects model||||
1614161|NCT02500979|2962389|Superiority or Other||LS mean difference (pramlintide-placebo)|-7.897||||0.0013|2-Sided|95.0|-12.356|-3.438|||Linear mixed effects model||||
1614162|NCT02500979|2962390|Superiority or Other||Least squares mean difference|-21.5|Standard Error of the Mean|7.88||0.0118|2-Sided|95.0|-37.8|-5.2|||Linear mixed-effects model||||
1614163|NCT02500836|2962394|Superiority||||||<|0.0001||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.|
1614164|NCT02500836|2962395|Superiority||||||<|0.0001||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.|
1614165|NCT02500706|2962449|Superiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 5: 1,5-anhydroglucitol superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Superiority was to be confirmed if the lower boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was above 0."|Treatment difference|0.02||||0.924|2-Sided|95.0|-0.31|0.34||p-values are from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA model after multiple imputation|||Change from baseline in 1,5-anhydroglucitol was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline 1,5-anhydroglucitol as a covariate.|
1614183|NCT02499900|2962496|Superiority||Mean Difference (Final Values)|-0.802||||0.208|2-Sided|95.0|-2.05|0.4461||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Total Score Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.|
1614339|NCT02494401|2963016|Superiority|||||||0.3||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614340|NCT02494401|2963016|Superiority|||||||0.32||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)||||
1614166|NCT02500706|2962450|Superiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: 1-hour postprandial glucose (PPG) increments superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog.~Superiority was confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0."|Treatment difference|-0.9|||<|0.001|2-Sided|95.0|-1.36|-0.45||p-value from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA|||Change from baseline in postprandial glucose increment (meal test) is analysed using an analysis of variance model. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline postprandial glucose increment as a covariate.|
1614167|NCT02500706|2962451|Superiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: HbA1c superiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Superiority was to be confirmed if the upper boundary of the two-sided 95% CI of the mean treatment difference (mealtime faster aspart minus mealtime NovoRapid®/NovoLog®) was below 0%-points."|Treatment difference|-0.02||||0.633|2-Sided|95.0|-0.11|0.07||p-value from the 2-sided test for treatment difference evaluated at the 5% level|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.|
1614168|NCT02500706|2962451|Non-Inferiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: HbA1c non-inferiority of postmeal faster aspart versus mealtime NovoRapid®/NovoLog®.~Non-inferiority of postmeal faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%"|Treatment difference|0.1|||<|0.001|2-Sided|95.0|0.004|0.19||p-value from the 2-sided test for treatment difference evaluated at the 5% level.|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.|
1614169|NCT02500706|2962451|Non-Inferiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®.~Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4%"|Treatment difference|-0.02|||<|0.001|2-Sided|95.0|-0.11|0.07||p-value from the 2-sided test for treatment difference evaluated at the 5% level|ANOVA model after multiple imputation|||The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.|
1614170|NCT02500641|2962452|Superiority|||||||0.5298|||||||ANCOVA||||
1614171|NCT02500628|2962453|Other|||||||0.92|||||||t-test, 2 sided|||difference between fibromyalgia and non-fibromyalgia patients.|
1614172|NCT02500628|2962454|Other|||||||0.27|||||||t-test, 2 sided||||
1614173|NCT02500628|2962455|Other|||||||0.77|||||||t-test, 2 sided|||comparison between fibromyalgia and non-fibromyalgia group|
1614174|NCT02499900|2962494|Superiority||Mean Difference (Final Values)|-0.059||||0.851|2-Sided|95.0|-0.6777|0.5592||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline BDI-II total score=baseline BDI-II total score+treatment+visit+country/geographic region +treatment by visit interaction.|
1614175|NCT02499900|2962495|Superiority||Mean Difference (Final Values)|-0.092||||0.919|2-Sided|95.0|-1.8565|1.6728||0.05 level of significance|Repeated Measures ANCOVA|||MHI Positive Affect subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.|
1614176|NCT02499900|2962495|Superiority||Mean Difference (Final Values)|1.867||||0.014|2-Sided|95.0|0.3843|3.3487||0.05 level of significance|Repeated Measures ANCOVA|||Behavioral Control subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.|
1614177|NCT02499900|2962495|Superiority||Mean Difference (Final Values)|0.481||||0.544|2-Sided|95.0|-1.0734|2.0348||0.05 level of significance|Repeated Measures ANCOVA|||Depression subscale estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.|
1614178|NCT02499900|2962495|Superiority||Mean Difference (Final Values)|0.141||||0.868|2-Sided|95.0|-1.5179|1.7991||0.05 level of significance|Repeated Measures ANCOVA|||Anxiety subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.|
1614179|NCT02499900|2962495|Superiority||Mean Difference (Final Values)|0.706||||0.287|2-Sided|95.0|-0.5947|1.0074||0.05 level of significance|Repeated Measures ANCOVA|||Total Score Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction.|
1614180|NCT02499900|2962496|Superiority||Mean Difference (Final Values)|0.102||||0.237|2-Sided|95.0|-0.0672|0.2711||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Psychosocial Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.|
1614181|NCT02499900|2962496|Superiority||Mean Difference (Final Values)|-0.639||||0.043|2-Sided|95.0|-1.2564|-0.0214||0.05 level of significance|Repeated Measures ANCOVA|||MFIS Cognitive Subscale Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MFIS score=baseline MFIS score+treatment+visit +CGR+treatment by visit interaction.|
1614317|NCT02494401|2963008|Superiority|||||||0.59||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)||||
1614318|NCT02494401|2963009|Superiority|||||||0.33||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614184|NCT02499900|2962497|Superiority||Mean Difference (Final Values)|9.448|||<|0.001|2-Sided|95.0|6.9538|11.9429||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: TSQM-9 convenience score=baseline TSQM-9 convenience score+treatment+CGR+treatment by visit interaction. Treatment-naïve patients are not included in this analysis as TSQM-9 is not measured at baseline for these patients.|
1614185|NCT02499900|2962498|Superiority||Mean Difference (Final Values)|0.321|||<|0.001|2-Sided|95.0|0.1615|0.4814||0.05 level of significance|Repeated Measures ANCOVA|||Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: MSQ=baseline MSQ score+treatment+visit+treatment by visit interaction. Treatment-naïve patients are not included in this analysis as MSQ is not measured at baseline for these patients.|
1614186|NCT02499783|2962502|Superiority||Least Squares Mean Difference|-16.844|||<|0.001|2-Sided|95.0|-21.206|-12.483||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in hs-CRP Level at Week 4|
1614187|NCT02499783|2962502|Superiority||Least Squares Mean Difference|-13.921|||<|0.001|2-Sided|95.0|-19.183|-8.659||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in hs-CRP Level at Week 2|
1614188|NCT02499783|2962504|Superiority||Least Squares Mean Difference|-66.63|||<|0.001|2-Sided|95.0|-84.2|-49.06||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in CDAI at Week 4|
1614189|NCT02499783|2962504|Superiority||Least Squares Mean Difference|-43.34|||<|0.001|2-Sided|95.0|-59.39|-27.3||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA|||Change From Baseline in CDAI at Week 2|
1614190|NCT02499783|2962506|Superiority||Adjusted Risk Difference|50.2|||<|0.001|2-Sided|95.0|36.9|63.5||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4|
1614191|NCT02499783|2962506|Superiority||Adjusted Risk Difference|31.4|||<|0.001|2-Sided|95.0|19.6|43.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 2|
1614192|NCT02499783|2962508|Superiority||Adjusted Risk Difference|40.4|||<|0.001|2-Sided|95.0|26.7|54.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4|
1614193|NCT02499783|2962508|Superiority||Adjusted Risk Difference|21.7|||<|0.001|2-Sided|95.0|8.7|34.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 2|
1614194|NCT02499783|2962510|Superiority||Adjusted Risk Difference|33.4|||<|0.001|2-Sided|95.0|23.2|43.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Clinical Remission (CDAI < 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 4|
1614195|NCT02499783|2962510|Superiority||Adjusted Risk Difference|21.4|||<|0.001|2-Sided|95.0|12.6|30.2||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Clinical Remission (CDAI < 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 2|
1614196|NCT02499783|2962512|Superiority||Adjusted Risk Difference|30.4|||<|0.001|2-Sided|95.0|19.2|41.7||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Clinical Remission at Week 4|
1614197|NCT02499783|2962512|Superiority||Adjusted Risk Difference|18.4|||<|0.001|2-Sided|95.0|8.2|28.6||Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Clinical Remission at Week 2|
1614319|NCT02494401|2963009|Superiority|||||||0.54||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)||||
1614320|NCT02494401|2963009|Superiority|||||||0.93||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)||||
1614198|NCT02499783|2962514|Superiority||Adjusted Risk Difference|9.8||||0.001|2-Sided|95.0|3.9|15.8||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline.||
1614199|NCT02499783|2962515|Superiority||Least Squares Mean Difference|-385.2|||<|0.001|2-Sided|95.0|-598.81|-171.5||P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate.|ANCOVA||||
1614200|NCT02499783|2962517|Superiority||Adjusted Risk Difference|19.6||||0.002|2-Sided|95.0|7.1|32.1||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline.||
1614201|NCT02499783|2962519|Superiority||Adjusted Risk Difference|27.6|||<|0.001|2-Sided|95.0|18.2|37.0||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline.||
1614202|NCT02499783|2962520|Superiority||Adjusted Risk Difference|50.2|||<|0.001|2-Sided|95.0|36.9|63.5||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline.||
1614203|NCT02499783|2962521|Superiority||Adjusted Risk Difference|40.4|||<|0.001|2-Sided|95.0|26.7|54.2||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline.||
1614204|NCT02499783|2962525|Superiority||Adjusted Risk Difference|33.4|||<|0.001|2-Sided|95.0|23.2|43.6||Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline.|Cochran-Mantel-Haenszel||Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by be stratified by Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline.||
1614205|NCT02499783|2962526|Superiority||Risk Difference Compared to 30%|34.6|||<|0.001|2-Sided|95.0|26.2|42.4|||One Sample Exact Test|The one sample Exact test was performed by comparing it to the clinically meaningful remission rate of 30%.|||
1614206|NCT02499783|2962527|Superiority||Adjusted Risk Difference|30.4|||<|0.001|2-Sided|95.0|19.2|41.7|||Cochran-Mantel-Haenszel|Stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.|Risk difference = (adalimumab 160/80 mg - placebo). Stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline.||
1614207|NCT02499406|2962537|Superiority||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.|
1614208|NCT02499406|2962538|Superiority||||||=|0||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=10||Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.|
1614209|NCT02499406|2962539|Superiority||||||>|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t test|df=14||Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.|
1614210|NCT02499406|2962540|Superiority||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=11||Null hypothesis is no difference between baseline and this 9-month assessment.|
1614211|NCT02499406|2962541|Superiority||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=10||Null hypothesis is no difference between baseline and this 6-month assessment.|
1614212|NCT02499406|2962542|Superiority||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired samples t test|df=14||Null hypothesis is that there is no difference in paired samples between baseline and 3-month assessment|
1614213|NCT02499406|2962543|Superiority||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 9-month assessment.|
1614214|NCT02499406|2962544|Superiority||||||<|0.016||||||p value was calculated and found to be below the a priori threshold for significance, which was adjusted to p = .016 for multiple comparisons|paired sample t-test|df=11||Null hypothesis is that there is no difference between baseline assessment and this 6-month assessment.|
1614215|NCT02499406|2962545|Superiority||||||<|0.016||||||a priori threshold for significance adjusted to p = .016 for multiple comparisons|paired sample t-test|df=14||Null hypothesis is that there is no difference between baseline assessment and this 3-month assessment.|
1614216|NCT02499120|2962639|Superiority||Hazard Ratio (HR)|1.0||||0.4953|2-Sided|95.0|0.669|1.495||1-sided p-value was from the log-rank test stratified by stratification factors ECOG per randomization.|Log Rank||||
1614217|NCT02499120|2962640|Superiority||Hazard Ratio (HR)|0.82||||0.18|2-Sided|95.0|0.536|1.253||1-sided p-value was from the log-rank test stratified by stratification factors ECOG(Eastern Cooperative Oncology Group) per randomization.|Log Rank||||
1614321|NCT02494401|2963010|Superiority|||||||0.23||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614322|NCT02494401|2963010|Superiority|||||||0.16||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)||||
1614218|NCT02499029|2962641|Superiority|||||||0.05|||||||Regression, Linear|||A series of hierarchical linear regression analyses were conducted to examine the effects of treatment group (NAC or placebo) on PTSD symptomatology, craving, substance use, and depression. Baseline levels of the respective outcome measures were entered in Step 1 of the model to adjust for any baseline differences. Treatment group was entered as the predictor in Step 2. The significance threshold was set at a p-value of .05 (two-sided) for all statistical tests.|
1614219|NCT02498769|2962660|Other|||||||0.97|||||||Chi-squared||||
1614220|NCT02498769|2962661|Other|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Hospital LOS|
1614221|NCT02498769|2962661|Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||ICU length of stay hours|
1614222|NCT02498769|2962662|Other||Odds Ratio (OR)|0.63||||0.19|2-Sided|95.0|0.31|1.27|||Regression, Logistic||||
1614223|NCT02498769|2962663|Other||Hazard Ratio (HR)|0.69||||0.18|2-Sided|95.0|0.41|1.19|||Regression, Cox||||
1614224|NCT02498652|2962674|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%|Geometric Least Squares Mean Ratio (%)|97.5|||||2-Sided|90.0|92.8|102.0|||||||
1614225|NCT02498652|2962674|Non-Inferiority|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.9|||||2-Sided|90.0|91.0|107.0|||||||
1614226|NCT02498652|2962674|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|92.0|||||2-Sided|90.0|86.7|97.7|||||||
1614227|NCT02498652|2962674|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|104.0|||||2-Sided|90.0|94.5|114.0|||||||
1614228|NCT02498652|2962674|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.0|||||2-Sided|90.0|90.4|106.0|||||||
1614229|NCT02498652|2962674|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|100.0|||||2-Sided|90.0|94.3|107.0|||||||
1614230|NCT02498652|2962677|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|101.0|||||2-Sided|90.0|85.5|119.0|||||||
1614231|NCT02498652|2962677|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|100.0|||||2-Sided|90.0|87.7|114.0|||||||
1614232|NCT02498652|2962677|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|88.9|||||2-Sided|90.0|78.4|101.0|||||||
1614233|NCT02498652|2962677|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|102.0|||||2-Sided|90.0|85.7|120.0|||||||
1614234|NCT02498652|2962677|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|92.6|||||2-Sided|90.0|78.1|110.0|||||||
1614235|NCT02498652|2962677|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|103.0|||||2-Sided|90.0|90.7|117.0|||||||
1614236|NCT02498418|2962689|Superiority||Difference in percentage of participants|0.033||||0.5987|2-Sided|95.0|-0.07|0.14||Threshold for significance at 0.05 level.|Z-test|||95% CIs was calculated using Z-test with Yates’ correction.|
1614237|NCT02498418|2962689|Superiority||Difference in percentage of participants|-0.0195||||0.7899|2-Sided|95.0|-0.09|0.13||Threshold of significance at 0.05 level.|Z-test|||95% CIs was calculated using Z-test with Yates’ correction.|
1614238|NCT02498418|2962692|Equivalence|Bioequivalence was demonstrated if 90% confidence interval (CI) of percentage difference between generic rifaximin 200 mg tablets and xifaxan 200 mg tablets was within the equivalence range (-20%, +20%).|Difference in percentage of participants|-0.0193|||||2-Sided|90.0|-0.11|0.07||||||Bioequivalence was evaluated based on the PP analysis set using Z-test with Yates correction.|
1614239|NCT02497937|2962738|Other||Mean Difference (Net)|0.793|||||2-Sided|95.0|-0.925|2.512|||||Difference estimate of DLco on Day 7 has been presented for Mayo site||
1614240|NCT02497469|2962777|Superiority||Adjusted Difference|-9.3||||0.0641|2-Sided|95.0|-18.9|0.4|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was <=5.
1614241|NCT02497469|2962778|Superiority||Adjusted Difference|11.9||||0.0005|2-Sided|95.0|5.3|18.5|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was <=5.
1614242|NCT02497469|2962779|Superiority||Adjusted Difference|8.8||||0.0061|2-Sided|95.0|2.5|15.0|||Cochran-Mantel-Haenszel||||P-value of the adjusted difference was based on the Cochran-Mantel-Haenszel method, stratified by concomitant use of oral corticosteroids (Yes/No) and prior use of TNF-alpha antagonist (Yes/No) or the Fisher's exact method if the numerator was <=5.
1614243|NCT02496533|2962831|Superiority or Other||||||<|0.45||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported pulse rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.|
1614244|NCT02496533|2962832|Superiority or Other||||||<|0.009||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported respiration rate between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.|
1614245|NCT02496533|2962833|Superiority or Other||||||<|0.09||||||No multiple comparisons were conducted in this analysis. P-Value not adjusted for multiple comparisons. No interim analyses were performed.|ANOVA|||H0: No difference in reported diastolic blood pressure between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.|
1614246|NCT02496533|2962833|Superiority or Other||||||<|0.02||||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported systolic blood pressure measurements between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.|
1614247|NCT02496533|2962834|Superiority or Other||Mean Difference (Net)|1.8|||<|0.001|2-Sided|||||No multiple comparisons were conducted in this analysis. P-value not adjusted for multiple comparisons. No interim analyses performed.|ANOVA|||H0: No difference in reported anxiety as self-reported change of VAS between Baseline and After Imaging time points between the Massage and No Massage groups After Imaging.|
1614248|NCT02496221|2962841|Superiority or Other||Mean Difference (Final Values)|-0.01456||||0.0733|2-Sided|95.0|-0.030666|0.001554|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect|||
1614249|NCT02496221|2962842|Superiority or Other||Mean Difference (Final Values)|0.001526||||0.9424|2-Sided|95.0|-0.045665|0.048717|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect|||
1614250|NCT02496221|2962844|Superiority or Other||Mean Difference (Final Values)|-0.3748||||0.7961|2-Sided|95.0|-3.4109|2.6614|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect|||
1614251|NCT02496221|2962845|Superiority or Other||Mean Difference (Final Values)|252.6099||||0.0291|2-Sided|95.0|29.5081|475.7117|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect|||
1614252|NCT02496221|2962846|Superiority or Other||Mean Difference (Final Values)|-16.2992||||0.0317|2-Sided|95.0|-31.0762|-1.5223|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect|||
1614253|NCT02496221|2962848|Superiority or Other||Mean Difference (Final Values)|-545.9585||||0.1291|2-Sided|95.0|-1260.0|168.0858|||Mixed Models Analysis||||
1614254|NCT02496221|2962849|Superiority or Other||Mean Difference (Final Values)|-9.0021||||0.1229|2-Sided|95.0|-20.5781|2.5739|||Mixed Models Analysis|Treatment (albiglutide or placebo), and period as fixed effects and participant as random effect|||
1614255|NCT02496091|2962855|Other||95% confidence interval (using the exact|92.7|||||2-Sided|95.0|88.8|95.5||||||Only descriptive statistics The implant success rate is analyzed on an implant level (i.e. percent of successful implants) as well as subject level (i.e. percentage of subjects with no unsuccessful implants). This proportion is presented together with a 95% confidence interval (using the exact Binomial approach) and an average follow-up time.|
1614256|NCT02496000|2962869|Superiority or Other (legacy)|||||||0.0117|||||||Kruskal-Wallis|ANOVA model on the ranks||This outcome measure requires that the the mean differences of ORMD-0801 in each of the two arms be pooled.|
1614257|NCT02495844|2962883|Superiority||Odds Ratio (OR)|4.14|||=|0|2-Sided|95.0|0.9|19.06|||Regression, Logistic||||
1614258|NCT02495831|2962887|Superiority or Other||geometric mean ratio|104.84|||||2-Sided|90.0|96.4|114.02|||||||
1614259|NCT02495831|2962888|Superiority or Other||point estimate (ratio of geometric means|90.0||||0.1|2-Sided|90.0|80.0|125.0||If the upper limit of the 90% confidence interval is < 125.00%, no effect of safinamide on diclofenamic acid bioavailability is present (no interaction present).|ANOVA|||The PK parameters AUC0-t and Cmax were analysed using analysis of variance (ANOVA). Before analysis, the data were transformed using a neperian logarithmic transformation. ANOVA was performed taking into account treatment, period, sequence and subject (sequence) as fixed effects with a variance components structure of the covariance matrix.|
1614260|NCT02495467|2962891|Superiority|||||||0.0003|||||||Prescott Test (Exact)||||
1614261|NCT02495467|2962892|Superiority||||||<|0.0001|||||||Prescott Test (Exact)||||
1614262|NCT02495467|2962893|Superiority||Means ratio|1.32||||0.0005|2-Sided|95.0|1.128|1.545|||Generalized Linear Mixed Model||||
1614263|NCT02495467|2962894|Superiority||Means ratio|1.522|||<|0.0001|2-Sided|95.0|1.267|1.829|||Generalized Linear Mixed Model||||
1614264|NCT02495467|2962895|Superiority||Means ratio|1.075||||0.0959|2-Sided|95.0|0.987|1.17|||Generalized Linear Mixed Model||||
1614265|NCT02495467|2962896|Superiority||Means ratio|0.989||||0.6746|2-Sided|95.0|0.937|1.043|||Generalized Linear Mixed Model||||
1614266|NCT02495467|2962897|Superiority||Means ratio|0.995||||0.7999|2-Sided|95.0|0.96|1.032|||Generalized Linear Mixed Model||||
1614267|NCT02495467|2962898|Superiority||Mean Difference (Final Values)|0.48||||0.001|2-Sided|95.0|0.2|0.76|||Mixed Models Analysis||||
1614268|NCT02495467|2962899|Superiority||Mean Difference (Final Values)|0.41||||0.0055|2-Sided|95.0|0.12|0.69|||Mixed Models Analysis||||
1614269|NCT02495467|2962900|Superiority||Mean Difference (Final Values)|0.39|||<|0.0001|2-Sided|95.0|0.21|0.57|||Mixed Models Analysis||||
1614270|NCT02495467|2962901|Superiority||Mean Difference (Final Values)|0.41||||0.0122|2-Sided|95.0|0.09|0.73|||Mixed Models Analysis||||
1614271|NCT02495467|2962902|Superiority||Mean Difference (Final Values)|1.03||||0.0132|2-Sided|95.0|0.22|1.84|||Mixed Models Analysis||||
1614272|NCT02495168|2962920|Superiority||LS Mean Difference|0.164|||<|0.0001|2-Sided|95.0|0.099|0.229||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on Symbicort and Placebo participants only.|
1614273|NCT02495168|2962920|Superiority||LS Mean Difference|0.159|||<|0.0001|2-Sided|95.0|0.093|0.226||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on generic budesonide/formoterol fumarate dihydrate and Placebo participants only.|
1614274|NCT02495168|2962921|Equivalence|To show the clinical equivalence, an ANCOVA model was fit on the participants from the generic budesonide/formoterol fumarate and Symbicort groups only, with the endpoint as outcome and treatment, study site and treatment-by site interaction as fixed effects and FEV1 baseline value as covariate. If the treatment-by-site interaction factor was not significant at the 0.05 level, the model was to be rerun without the interaction term.|Test/Reference LS Mean Ratio|99.8|||||2-Sided|90.0|87.0|114.5|||||Fieller’s formula was applied to calculate the 90% CI for the generic budesonide/formoterol fumarate and Symbicort LS mean ratio; covariance between treatment means was assumed to be 0.||
1614275|NCT02495168|2962922|Superiority||LS Mean Difference|2.606|||<|0.0001|2-Sided|95.0|1.939|3.273||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on Symbicort and Placebo participants only.|
1614323|NCT02494401|2963010|Superiority|||||||0.28||||||p value for baseline comparison|Wilcoxon (Mann-Whitney)||||
1614276|NCT02495168|2962922|Superiority||LS Mean Difference|2.334|||<|0.0001|2-Sided|95.0|1.673|2.996||Threshold for significance at 0.05 level.|ANCOVA|||LS means difference and p-value from ANCOVA model with treatment and site as fixed effects, baseline FEV1 as covariate and endpoint as outcome on generic budesonide/formoterol fumarate dihydrate and Placebo participants only.|
1614277|NCT02495168|2962923|Equivalence|To show the clinical equivalence, an analysis of covariance (ANCOVA) model was fit on the participants from the generic budesonide/formoterol fumarate and Symbicort groups only, with the endpoint as outcome and treatment, study site and treatment by site interaction as fixed effects and FEV1 baseline value as covariate. If the treatment-by-site interaction factor was not significant at the 0.05 level, the model was to be rerun without the interaction term.|Test/Referece LS Mean Ratio|101.9|||||2-Sided|90.0|92.7|111.9|||||Fieller’s formula was applied to calculate the 90% confidence interval (CI) for the generic budesonide/formoterol fumarate and Symbicort LS mean ratio; covariance between treatment means was assumed to be 0.||
1614278|NCT02494583|2962974|Other||Difference in LS Means|-6.56||||0.001|2-Sided|95.0|-10.55|-2.58||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.|
1614279|NCT02494583|2962975|Other||Difference in LS Means|2.35||||0.308|2-Sided|95.0|-2.18|6.89||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-STO22 Pain symptom subscale score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.|
1614280|NCT02494583|2962976|Other||Difference in LS Means|1.98||||0.368|2-Sided|95.0|-2.34|6.31||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.|
1614281|NCT02494583|2962977|Other||Difference in LS Means|-0.16||||0.948|2-Sided|95.0|-5.01|4.69||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|cLDA||Stratified analyses could be based on collapsing strata with insufficient number of participants or events; strata were pooled in some cases based on clinical judgement and actual counts.|Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the SOC arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.|
1614282|NCT02494583|2962978|Other||Hazard Ratio (HR)|1.64||||1|2-Sided|95.0|1.36|1.98||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the SOC arm based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.|
1614283|NCT02494583|2962980|Other||Difference in ORR Percentage|-22.3|||>|0.99999|2-Sided|95.0|-29.6|-14.9||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen & Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.|
1614284|NCT02494583|2962982|Other||Difference in ORR Percentage|11.5||||0.00447|2-Sided|95.0|2.9|20.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen & Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.|
1614285|NCT02494583|2962983|Superiority||Hazard Ratio (HR)|0.69||||0.01491|2-Sided|95.0|0.49|0.97||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥10 participants of the pembro mono arm was compared to OS in CPS ≥10 participants of the SOC arm to address the sixth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.|
1614324|NCT02494401|2963011|Superiority|||||||0.07||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614325|NCT02494401|2963011|Superiority|||||||0.29||||||p value for 16 week comparison|Wilcoxon (Mann-Whitney)||||
1614326|NCT02494401|2963011|Superiority|||||||0.69||||||p value for baseline comparison|Wilcoxon (Mann-Whitney)||||
1614327|NCT02494401|2963012|Superiority|||||||0.56||||||p value for 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614286|NCT02494583|2962984|Superiority||Hazard Ratio (HR)|0.91||||0.16205|2-Sided|95.0|0.74|1.1||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fifth primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.|
1614287|NCT02494583|2962984|Non-Inferiority|Pre-specified non-inferiority margin: if the upper bound of the confidence interval (based on the alpha level allocated to the analysis) for the hazard ratio ([HR], pembro mono arm vs SOC) is < 1.2, the pembro mono arm could be considered as non-inferior to the SOC arm in terms of OS.|Hazard Ratio (HR)|0.91|||||2-Sided|99.2|0.69|1.18|||||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the SOC arm to address the fourth primary hypothesis (non-inferiority to SOC). The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.|
1614288|NCT02494583|2962985|Superiority||Hazard Ratio (HR)|0.85||||0.15804|2-Sided|95.0|0.62|1.17||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥10 participants of the pembro combo arm was compared to OS in CPS ≥10 participants of the SOC arm to address the third primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.|
1614289|NCT02494583|2962986|Superiority||Hazard Ratio (HR)|0.85||||0.04611|2-Sided|95.0|0.7|1.03||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the SOC arm to address the second primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and Fluoropyrimidine treatment.|
1614290|NCT02494583|2962987|Superiority||Hazard Ratio (HR)|0.84||||0.03918|2-Sided|95.0|0.7|1.02||One-sided p-value based on log-rank test with stratification.|Regression, Cox||Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.|PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the SOC arm to address the first primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.|
1614291|NCT02494401|2963000|Superiority|||||||0.82||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614292|NCT02494401|2963000|Superiority|||||||0.89||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)||||
1614293|NCT02494401|2963000|Superiority|||||||0.87||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)||||
1614294|NCT02494401|2963001|Superiority|||||||0.49||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614295|NCT02494401|2963001|Superiority|||||||0.58||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)||||
1614296|NCT02494401|2963001|Superiority|||||||0.29||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)||||
1614297|NCT02494401|2963002|Superiority|||||||0.7||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614298|NCT02494401|2963002|Superiority|||||||0.62||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)||||
1614299|NCT02494401|2963002|Superiority|||||||0.05||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)||||
1614300|NCT02494401|2963003|Superiority|||||||0.63||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614301|NCT02494401|2963003|Superiority|||||||0.87||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)||||
1614302|NCT02494401|2963003|Superiority|||||||0.95||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)||||
1614303|NCT02494401|2963004|Superiority|||||||0.04||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614304|NCT02494401|2963004|Superiority|||||||0.82||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)||||
1614305|NCT02494401|2963004|Superiority|||||||0.73||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)||||
1614306|NCT02494401|2963005|Superiority|||||||0.09||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614307|NCT02494401|2963005|Superiority|||||||0.8||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)||||
1614308|NCT02494401|2963005|Superiority|||||||0.64||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)||||
1614309|NCT02494401|2963006|Superiority|||||||0.18||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614310|NCT02494401|2963006|Superiority|||||||0.27||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)||||
1614311|NCT02494401|2963006|Superiority|||||||0.83||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)||||
1614312|NCT02494401|2963007|Superiority|||||||0.84||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614313|NCT02494401|2963007|Superiority|||||||0.93||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)||||
1614314|NCT02494401|2963007|Superiority|||||||0.51||||||p value of baseline comparison|Wilcoxon (Mann-Whitney)||||
1614315|NCT02494401|2963008|Superiority|||||||0.12||||||p value of 6 month comparison|Wilcoxon (Mann-Whitney)||||
1614316|NCT02494401|2963008|Superiority|||||||0.25||||||p value of 16 week comparison|Wilcoxon (Mann-Whitney)||||
1614341|NCT02494401|2963016|Superiority|||||||0.87||||||p value of baseline comparison.|Wilcoxon (Mann-Whitney)||||
1614342|NCT02494323|2963024|Superiority or Other||||||<|0.01||||||P value is adjusted for the comparison of subjects who benefited, were satisfied and willing to continue using the Segmented Electrodes versus subjects who didn't benefit, wern't satisfied ans were not willing to continue using the Segmented Eletrode|t-test, 1 sided||||
1614343|NCT02493946|2963048|Superiority||Treatment difference|-1.4|||<|0.0001|2-Sided|95.0|-2.1|-0.8||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution – Placebo) at Day 85 Cycle 1.|
1614344|NCT02493946|2963048|Superiority||Treatment difference|-1.4|||<|0.0001|2-Sided|95.0|-2.0|-0.7||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution – Placebo) at Day 57 Cycle 1.|
1614345|NCT02493946|2963048|Superiority||Treatment difference|-1.2|||<|0.0001|2-Sided|95.0|-1.7|-0.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution – Placebo) at Day 29 Cycle 1.|
1614346|NCT02493946|2963048|Superiority||Treatment difference|-0.6|||<|0.0174|2-Sided|95.0|-1.1|-0.1||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution – Placebo) at Day 8 Cycle 1.|
1614347|NCT02493946|2963049|Superiority||Treatment difference|8.1||||0.0004|2-Sided|95.0|3.7|12.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution – Placebo) at Day 85 Cycle 1.|
1614348|NCT02493946|2963049|Superiority||Treatment difference|11.2|||<|0.0001|2-Sided|95.0|6.4|15.9||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution – Placebo) at Day 57 Cycle 1.|
1614349|NCT02493946|2963049|Superiority||Treatment difference|11.4|||<|0.0001|2-Sided|95.0|6.7|16.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution – Placebo) at Day 29 Cycle 1.|
1614350|NCT02493946|2963049|Superiority||Treatment difference|9.3|||<|0.0001|2-Sided|95.0|5.0|13.6||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariate.|General linear model|||Treatment difference (BTX-A-HAC Solution – Placebo) at Day 8 Cycle 1.|
1614351|NCT02493946|2963050|Superiority||Treatment difference|9.6|||<|0.0001|2-Sided|95.0|5.9|13.3||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution – Placebo) at Day 85 Cycle 1.|
1614352|NCT02493946|2963050|Superiority||Treatment difference|10.4|||<|0.0001|2-Sided|95.0|6.8|14.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution – Placebo) at Day 57 Cycle 1.|
1614353|NCT02493946|2963050|Superiority||Treatment difference|11.1|||<|0.0001|2-Sided|95.0|7.4|14.8||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference (BTX-A-HAC Solution – Placebo) at Day 29 Cycle 1.|
1614354|NCT02493946|2963050|Superiority||Treatment difference|8.6|||<|0.0001|2-Sided|95.0|5.2|12.0||The general linear model included mean change from baseline as a dependent variable and treatment group, gender and centre as fixed effects, and baseline severity score on ILA at maximum frown as covariates.|General linear model|||Treatment difference ( BTX-A-HAC Solution – Placebo) at Day 8 Cycle 1.|
1614355|NCT02493946|2963051|Superiority||Hazard Ratio (HR)|15.296|||<|0.0001|2-Sided||||||Cox proportional hazard model|The cox proportional hazard model used centre, gender and ILA baseline severity score as covariates.||Treatment difference in median time to onset of treatment response.|
1614356|NCT02493946|2963052|Superiority||Treatment difference|51.0|||<|0.0001|2-Sided|95.0|42.0|59.9||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.|
1614357|NCT02493946|2963052|Superiority||Treatment difference|74.4|||<|0.0001|2-Sided|95.0|65.7|83.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.|
1614358|NCT02493946|2963052|Superiority||Treatment difference|77.4|||<|0.0001|2-Sided|95.0|68.6|86.2||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.|
1614359|NCT02493946|2963052|Superiority||Treatment difference|68.2|||<|0.0001|2-Sided|95.0|58.2|78.3||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Linear|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.|
1615073|NCT02473471|2964573|Other|||||||0.59|||||||t-test, 2 sided|||Root length at baseline.|
1614360|NCT02493946|2963053|Superiority||Treatment difference|33.0|||<|0.0001|2-Sided|95.0|24.0|42.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.|
1614361|NCT02493946|2963053|Superiority||Treatment difference|70.5|||<|0.0001|2-Sided|95.0|62.2|78.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.|
1614362|NCT02493946|2963053|Superiority||Treatment difference|65.8|||<|0.0001|2-Sided|95.0|56.8|74.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.|
1614363|NCT02493946|2963053|Superiority||Treatment difference|61.1|||<|0.0001|2-Sided|95.0|51.9|70.3||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.|
1614364|NCT02493946|2963054|Superiority||Treatment difference|42.6|||<|0.0001|2-Sided|95.0|29.5|55.7||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.|
1614365|NCT02493946|2963054|Superiority||Treatment difference|62.5|||<|0.0001|2-Sided|95.0|52.1|72.9||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.|
1614366|NCT02493946|2963054|Superiority||Treatment difference|56.8|||<|0.0001|2-Sided|95.0|44.5|69.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 29 Cycle 1.|
1614367|NCT02493946|2963054|Superiority||Treatment difference|58.0|||<|0.0001|2-Sided|95.0|44.5|71.6||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.|
1614368|NCT02493946|2963056|Superiority||Treatment difference|53.6|||<|0.0001|2-Sided|95.0|44.2|63.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 85 Cycle 1.|
1614369|NCT02493946|2963056|Superiority||Treatment difference|74.1|||<|0.0001|2-Sided|95.0|66.2|82.1||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 57 Cycle 1.|
1614370|NCT02493946|2963056|Superiority||Treatment difference|75.0|||<|0.0001|2-Sided|95.0|67.1|82.8||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders at Day 8 Cycle 1.|
1614371|NCT02493946|2963057|Superiority||Treatment difference|80.8|||<|0.0001|2-Sided|95.0|73.7|88.0||The treatment difference and p-value were obtained from a logistic regression on responders with treatment group, gender, baseline severity score on ILA at maximum frown and centre as fixed variables.|Regression, Logistic|||Treatment difference against placebo in the adjusted percentage of responders.|
1614372|NCT02493868|2963075|Superiority||Hazard Ratio (HR)|0.49|||=|0|2-Sided|95.0|0.29|0.84|||Weighted Log-rank||||
1614373|NCT02493855|2963076|Superiority|This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.||||||0.561|||||||Wilcoxon Rank Sum Test||||
1614374|NCT02493855|2963076|Superiority|This study was an exploratory study to evaluate the effect of ribavirin on the slope of the second phase of HCV RNA decline in participants who received the 3-direct-acting antiviral agent regimen.||||||0.311|||||||Wilcoxon Rank Sum Test||||
1614375|NCT02493777|2963077|Superiority||||||<|0.001|||||||Mixed model repeated measures analysis||||
1614376|NCT02493777|2963078|Superiority||||||<|0.001|||||||Mixed model repeated measures analysis||||
1614377|NCT02493764|2963079|Other|Difference in FMR|Adjusted difference in FMR|4.7|||||2-Sided|95.0|-4.0|14.1|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable microbiological response|
1614378|NCT02493764|2963080|Other|Difference in FMR|Adjusted difference in FMR|2.5|||||2-Sided|95.0|-5.5|11.0|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable microbiological response|
1614379|NCT02493764|2963081|Other|Difference in FMR|Adjusted difference in FMR|6.2|||||2-Sided|95.0|-2.7|15.0|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable microbiological response|
1614380|NCT02493764|2963082|Other|Difference in FMR|Adjusted difference in FMR|9.7|||||2-Sided|95.0|1.6|17.9|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable microbiological response|
1614381|NCT02493764|2963083|Other|Difference in FCR|Adjusted difference in FCR|1.1|||||2-Sided|95.0|-7.2|9.4|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable clinical response|
1615538|NCT02451839|2966002|Superiority||||||<|0.001|||||||paired t-test||||
1614382|NCT02493764|2963084|Other|Difference in FCR|Adjusted difference in FCR|4.4|||||2-Sided|95.0|-3.1|12.0|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable clinical response|
1614383|NCT02493764|2963085|Other|Difference in FCR|Adjusted difference in FCR|3.4|||||2-Sided|95.0|-7.1|14.2|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable clinical response|
1614384|NCT02493764|2963086|Other|Difference in FCR|Adjusted difference in FCR|0.5|||||2-Sided|95.0|-6.3|7.4|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable clinical response|
1614385|NCT02493764|2963087|Other|Difference in FCR|Adjusted difference in FCR|3.5|||||2-Sided|95.0|-4.6|11.6|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable clinical response|
1614386|NCT02493764|2963088|Other|Difference in FCR|Adjusted difference in FCR|-3.7|||||2-Sided|95.0|-13.6|6.4|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable clinical response|
1614387|NCT02493764|2963089|Other|Difference in FCR|Adjusted difference in FCR|-3.4|||||2-Sided|95.0|-14.3|7.5|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable clinical response|
1614388|NCT02493764|2963090|Other|Difference in FCR|Adjusted difference in FCR|-0.4|||||2-Sided|95.0|-8.1|7.4|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable clinical response|
1614389|NCT02493764|2963091|Other|Difference in favorable clinical response|Adjusted difference in FCR|6.6|||||2-Sided|95.0|-4.6|18.4|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable clinical response|
1614390|NCT02493764|2963092|Other|Difference in FCR|Adjusted difference in FCR|-2.2|||||2-Sided|95.0|-9.8|5.5|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable clinical response|
1614391|NCT02493764|2963093|Other|Difference in FCR|Adjusted difference in FCR|-1.7|||||2-Sided|95.0|-11.3|7.8|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in favorable clinical response|
1614392|NCT02493764|2963094|Other|Adjusted difference in ACM|Adjusted difference in ACM|-3.1|||||2-Sided|95.0|-10.2|3.8|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in all-cause mortality|
1614393|NCT02493764|2963095|Non-Inferiority|Non-inferiority was declared when the upper bound of the 2-sided 95% CI for the difference in mortality (IMI/REL minus PIP/TAZ) was ≥ 10 percentage points.|Adjusted difference in ACM|-4.6|||||2-Sided|95.0|-11.0|1.7|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in all-cause mortality|
1614394|NCT02493764|2963096|Other||Adjusted difference in ACM|-3.5|||||2-Sided|95.0|-10.9|3.6|||||Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in all-cause mortality|
1614395|NCT02493764|2963097|Other|Difference in % discontinuing vs PIP/TAZ|Difference in % discontinuing|-2.5|||||2-Sided|95.0|-7.1|1.8|||||||
1614396|NCT02493764|2963098|Other|Difference in % with AE vs PIP/TAZ|Difference in % with AE|-1.7|||||2-Sided|95.0|-7.7|4.3|||||||
1614397|NCT02493764|2963099|Non-Inferiority|Non-inferiority was declared when the lower bound of the 2-sided 95% CI for the difference in FCR (IMI/REL minus PIP/TAZ) was > 12.5 percentage points.|Adjusted difference in FCR|5.0|||<|0.001|2-Sided|95.0|-3.2|13.2|||t-test, 1 sided|A one-sided alpha level of 0.025 was used to declare significance.|Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in FCR|
1614398|NCT02493764|2963100|Non-Inferiority|Non-inferiority was declared when the upper bound of the 2-sided 95% confidence interval (CI) for the difference in mortality (IMI/REL minus PIP/TAZ) was < 10 percentage points.|Adjusted difference in ACM|-5.3|||<|0.001|2-Sided|95.0|-11.9|1.2|||t-test, 1 sided|A one-sided alpha level of 0.025 was used to declare significance.|Adjusted difference and 95% CI are based on the Miettinen & Nurminen method.|Adjusted difference in all-cause mortality|
1614399|NCT02493608|2963104|Other|||||||0.113|||||||t-test, 2 sided||||
1614400|NCT02493608|2963105|Other|||||||0.638||||||POD 2|t-test, 2 sided||||
1614401|NCT02493608|2963105|Other|||||||0.218||||||POD 1|t-test, 2 sided||||
1614402|NCT02493608|2963106|Other||||||<|0.001|||||||t-test, 2 sided||||
1614403|NCT02493517|2963109|Other||Risk Difference (RD)|-5.5|||||2-Sided|95.0|-24.3|13.3||||||Risk difference (lanreotide Autogel - lanreotide PR) in the percentage of subjects with at least 20% reduction in the solid component of tumour volume compared to Baseline is presented.|
1614404|NCT02493517|2963110|Other||Treatment difference|3.63|Standard Deviation|21.6|||2-Sided|95.0|-3.98|11.25||||||Treatment difference (lanreotide Autogel - lanreotide PR) is presented.|
1614405|NCT02493517|2963111|Other||Risk Difference (RD)|4.7|||||2-Sided|95.0|-3.1|12.5||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage subjects with normal IGF-1 levels and who have GH levels >1 mcg/L and ≤2.5 mcg/L at EOST/EW Visit is presented.|
1614406|NCT02493517|2963112|Other||Risk Difference (RD)|1.6|||||2-Sided|95.0|-8.9|12.0||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of GH levels ≤1 mcg/L at EOST/EW Visit is presented.|
1614407|NCT02493517|2963113|Other||Risk Difference (RD)|-1.6|||||2-Sided|95.0|-17.5|14.4||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of GH levels ≤2.5 mcg/L at EOST/EW Visit is presented.|
1614408|NCT02493517|2963114|Other||Risk Difference (RD)|6.3|||||2-Sided|95.0|-5.2|17.7||||||The risk difference (lanreotide Autogel - lanreotide PR) in the percentage of normal IGF-1 SDS values at EOST/EW Visit is presented.|
1614409|NCT02493517|2963115|Non-Inferiority|The non-inferiority margin for the back-transformed LS Mean ratio of IGF-1 SDS of lanreotide Autogel versus lanreotide PR is exp (0.6) = 1.822.|LS Mean ratio|0.73|||||2-Sided|95.0|0.48|1.11||||||"The LS Means and 95% CIs were based on the GLM with IGF-1 SDS change from baseline values as dependent variable, with treatment group and previous pituitary surgery as independent factors, and the baseline value of IGF-1 SDS as independent covariate. A log-transformation with base e was applied to the IGF-1 SDS data before analysing.~The LS Mean ratio (lanreotide Autogel versus lanreotide PR) is presented."|
1614515|NCT02489773|2963364|Other|Calculate the pearson correlation within whole subjects (across Group 1 and Group 2)|pearson correlation coefficient|0.6342|||>||2-Sided||||||||||
1614410|NCT02493517|2963115|Non-Inferiority|The non-inferiority margin is defined as 0.6 SDS for the upper limit of 95% CI of the LS mean difference of the log-transformed IGF-1 SDS without back-transformation.|Treatment difference|-0.32|||||2-Sided|95.0|-0.74|0.11||||||"The Least Square (LS) Means and 95% Confidence Intervals (CIs) were based on the generalised linear model (GLM) with IGF-1 SDS change from baseline values as dependent variable, with treatment group and previous pituitary surgery as independent factors, and the baseline value of IGF-1 SDS as independent covariate. A log-transformation with base e was applied to the IGF-1 SDS data before analysing.~The treatment difference (lanreotide Autogel - lanreotide PR) is presented."|
1614411|NCT02492802|2963180|Other|||||||0.77|||||||The Wald Type III test||||
1614412|NCT02492763|2963181|Superiority||Difference in the Least Squares Means|1.6||||0.325|2-Sided|95.0|-1.6|4.9|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614413|NCT02492763|2963181|Superiority||Difference in Least Squares Means|-0.2||||0.905|2-Sided|95.0|-3.5|3.1|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614414|NCT02492763|2963181|Superiority||Difference in Least Squares Means|1.4||||0.394|2-Sided|95.0|-1.9|4.7|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614415|NCT02492763|2963181|Superiority||Difference in Least Squares Means|-0.1||||0.963|2-Sided|95.0|-3.3|3.2|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614416|NCT02492763|2963181|Superiority||Difference in Least Squares Means|1.5||||0.347|2-Sided|95.0|-1.7|4.8|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614417|NCT02492763|2963182|Superiority||Difference in the Least Squares Means|-2.7||||0.306|2-Sided|95.0|-7.8|2.5||Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis||||
1614418|NCT02492763|2963182|Superiority||Difference in Least Squares Means|0.2||||0.948|2-Sided|95.0|-5.0|5.4|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614419|NCT02492763|2963182|Superiority||Difference in Least Squares Means|-2.5||||0.344|2-Sided|95.0|-7.7|2.7|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614420|NCT02492763|2963182|Superiority||Difference in Least Squares Means|-1.1||||0.682|2-Sided|95.0|-6.2|4.1|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614421|NCT02492763|2963182|Superiority||Difference in Least Squares Means|-3.7||||0.151|2-Sided|95.0|-8.8|1.4|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614422|NCT02492763|2963186|Superiority||Difference in the Least Squares Means|-37.8|||<|0.001|2-Sided|95.0|-57.5|-18.0||Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis||||
1614423|NCT02492763|2963186|Superiority||Difference in Least Squares Means|8.3|||<|0.416|2-Sided|95.0|-11.7|28.2|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614424|NCT02492763|2963186|Superiority||Difference in Least Squares Means|-29.5|||<|0.004|2-Sided|95.0|-49.6|-9.4|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614425|NCT02492763|2963186|Superiority||Difference in Least Squares Means|29.1|||<|0.004|2-Sided|95.0|9.7|48.6|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614426|NCT02492763|2963186|Superiority||Difference in Least Squares Means|-8.6|||<|0.385|2-Sided|95.0|-28.2|10.9|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614427|NCT02492763|2963187|Superiority||Difference in the Least Squares Means|-1.6||||0.018|2-Sided|95.0|-2.9|-0.3||Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis||||
1614428|NCT02492763|2963187|Superiority||Difference in Least Squares Means|-0.2||||0.811|2-Sided|95.0|-1.5|1.2|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614429|NCT02492763|2963187|Superiority||Difference in Least Squares Means|-1.8||||0.01|2-Sided|95.0|-3.1|-0.4|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614430|NCT02492763|2963187|Superiority||Difference in Least Squares Means|0.9||||0.183|2-Sided|95.0|-0.4|2.2|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614431|NCT02492763|2963187|Superiority||Difference in Least Squares Means|-0.7||||0.285|2-Sided|95.0|-2.0|0.6|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614562|NCT02485561|2963724|Superiority||Mean Difference (Final Values)|0.716|Standard Error of the Mean|0.182|<|0.001|2-Sided||||||t-test, 2 sided||||
1615539|NCT02451839|2966003|Superiority|||||||0.015|||||||paired t-test||||
1614432|NCT02492763|2963188|Superiority||Difference in LS Means vs. Liraglutide|4.65|||||2-Sided|95.0|1.11|8.19|||||Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis
1614433|NCT02492763|2963188|Superiority||Difference in LS Means vs. Placebo|7.7|||||2-Sided|95.0|4.17|11.23|||||Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis
1614434|NCT02492763|2963188|Superiority||Difference in LS Means vs. Liraglutide|3.84|||||2-Sided|95.0|0.35|7.33|||||Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis
1614435|NCT02492763|2963188|Superiority||Difference in the LS Means vs. Placebo|6.9|||||2-Sided|95.0|3.42|10.37|||||Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment||Longitudinal data analysis
1614436|NCT02492763|2963189|Superiority||Difference in % vs Liraglutide|2.2||||0.587|2-Sided|95.0|-8.4|13.2|||Miettinen & Nurminen method||||
1614437|NCT02492763|2963189|Superiority||Difference in % vs Liraglutide|-2.4||||0.295|2-Sided|95.0|-12.4|5.5|||Miettinen & Nurminen method||||
1614438|NCT02492763|2963189|Superiority||Difference in % vs Placebo|2.2||||0.573|2-Sided|95.0|-8.1|13.2|||Miettinen & Nurminen method||||
1614439|NCT02492763|2963189|Superiority||Difference in % vs Placebo|-2.3||||0.301|2-Sided|95.0|-12.1|5.6|||Miettinen & Nurminen method||||
1614440|NCT02492763|2963192|Superiority||Difference in the Least Squares Means|-0.98|||<|0.001|2-Sided|95.0|-1.49|-0.48||Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|Longitudinal data analysis||||
1614441|NCT02492763|2963192|Superiority||Difference in Least Squares Means|0.37|||<|0.146|2-Sided|95.0|-0.13|0.87|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614442|NCT02492763|2963192|Superiority||Difference in Least Squares Means|-0.61|||<|0.018|2-Sided|95.0|-1.12|-0.1|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614443|NCT02492763|2963192|Superiority||Difference in Least Squares Means|0.6|||<|0.017|2-Sided|95.0|0.11|1.08|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614444|NCT02492763|2963192|Superiority||Difference in Least Squares Means|-0.39|||<|0.126|2-Sided|95.0|-0.88|0.11|||Longitudinal data analysis|Terms for treatment, time, A1C (<8.5%, ≥8.5%), BMI (<30 kg/m^2, ≥30 kg/m^2) and AHA washout status (Yes, No), and the interaction of time by treatment|||
1614445|NCT02492750|2963195|Other||Maximum Tolerated Dose (MTD) Level|3.0|||||2-Sided||||||||MTD is defined as the dose level below the lowest dose that induces DLT in at least one-third of patients. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.||
1614446|NCT02491684|2963254|Superiority or Other||LS Mean difference|0.09||||0.134|2-Sided|95.0|-0.03|0.22|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.|
1614447|NCT02491684|2963254|Superiority or Other||LS Mean difference|0.05||||0.315|2-Sided|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.|
1614448|NCT02491684|2963254|Superiority or Other||LS Mean difference|0.04||||0.457|2-Sided|95.0|-0.06|0.14|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.|
1614449|NCT02491684|2963254|Superiority or Other||LS Mean difference|0.06||||0.287|2-Sided|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.|
1614450|NCT02491684|2963255|Superiority or Other||LS Mean difference|17.13||||0.161|2-Sided|95.0|-6.92|41.18|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.|
1614451|NCT02491684|2963255|Superiority or Other||LS Mean difference|11.14||||0.277|2-Sided|95.0|-9.08|31.36|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.|
1614452|NCT02491684|2963255|Superiority or Other||LS Mean difference|11.19||||0.125|2-Sided|95.0|-3.18|25.56|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.|
1614453|NCT02491684|2963255|Superiority or Other||LS Mean difference|11.69||||0.211|2-Sided|95.0|-6.76|30.14|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.|
1614454|NCT02491684|2963256|Superiority or Other||LS Mean difference|0.11||||0.086|2-Sided|95.0|-0.02|0.24|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.|
1614455|NCT02491684|2963256|Superiority or Other||LS Mean difference|0.06||||0.28|2-Sided|95.0|-0.05|0.16|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.|
1614563|NCT02485561|2963724|Superiority||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.15|<|0.91|2-Sided||||||t-test, 2 sided||||
1614456|NCT02491684|2963256|Superiority or Other||LS Mean difference|0.08||||0.087|2-Sided|95.0|-0.01|0.17|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.|
1614457|NCT02491684|2963256|Superiority or Other||LS Mean difference|0.07||||0.161|2-Sided|95.0|-0.03|0.17|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.|
1614458|NCT02491684|2963257|Superiority or Other||LS Mean difference|19.26||||0.096|2-Sided|95.0|-3.44|41.97|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 15-30.|
1614459|NCT02491684|2963257|Superiority or Other||LS Mean difference|14.38||||0.153|2-Sided|95.0|-5.44|34.2|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 8-14.|
1614460|NCT02491684|2963257|Superiority or Other||LS Mean difference|19.35||||0.01|2-Sided|95.0|4.66|34.05|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-7.|
1614461|NCT02491684|2963257|Superiority or Other||LS Mean difference|16.98||||0.059|2-Sided|95.0|-0.63|34.6|||ANCOVA|Analysis uses an ANCOVA model with treatment, region, gender, and smoking status as factors, and baseline value and height as covariates.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.|
1614462|NCT02491684|2963258|Superiority or Other||LS Mean difference|0.54||||0.309|2-Sided|95.0|-0.51|1.59|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline over Days 1-14.|
1614463|NCT02491684|2963259|Superiority or Other||LS Mean difference|-0.09||||0.624|2-Sided|95.0|-0.48|0.29|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in overall score at Visit 8.|
1614464|NCT02491684|2963259|Superiority or Other||LS Mean difference|-0.07||||0.66|2-Sided|95.0|-0.38|0.24|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in overall score at Visit 6.|
1614465|NCT02491684|2963261|Superiority or Other||LS Mean difference|0.0||||0.985|2-Sided|95.0|-0.35|0.35|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 15-30.|
1614466|NCT02491684|2963261|Superiority or Other||LS mean difference|0.01||||0.954|2-Sided|95.0|-0.34|0.36|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 8-14.|
1614467|NCT02491684|2963261|Superiority or Other||LS mean difference|0.11||||0.417|2-Sided|95.0|-0.16|0.37|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 1-7.|
1614468|NCT02491684|2963261|Superiority or Other||LS Mean difference|0.11||||0.516|2-Sided|95.0|-0.23|0.45|||ANCOVA|AUC for change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of AUC for change from baseline in total score over Days 1-14.|
1614469|NCT02491684|2963262|Superiority or Other||LS Mean Difference|-0.07||||0.687|2-Sided|95.0|-0.42|0.28|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in total score at Visit 8.|
1614470|NCT02491684|2963262|Superiority or Other||LS Mean Difference|0.06||||0.715|2-Sided|95.0|-0.26|0.38|||ANCOVA|Change from baseline is analysed using an ANCOVA model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo|Analysis of change from baseline in total score at Visit 6.|
1614471|NCT02491684|2963262|Superiority or Other||Least Squares (LS) Mean difference|0.09||||0.495|2-Sided|95.0|-0.17|0.35|||ANCOVA|Change from baseline is analysed using an Analysis of Covariance (ANCOVA) model with treatment and region as factors and baseline value as covariate.|AZD9412 versus Placebo for change from baseline in total score at Visit 4.|Analysis of change from baseline in total score at Visit 4.|
1614472|NCT02491684|2963264|Superiority or Other||Hazard Ratio (HR)|1.05||||0.973|2-Sided|95.0|0.07|16.78|||Regression, Cox|Hazard ratio was calculated adjusting for treatment group and region.|AZD9412 versus Placebo|Analysis of time to first moderate exacerbation within 30 days of treatment start.|
1614473|NCT02491684|2963265|Superiority or Other||Hazard Ratio (HR)|1.3||||0.634|2-Sided|95.0|0.45|3.77|||Regression, Cox|Hazard ratio was calculated adjusting for treatment group and region.|AZD9412 versus Placebo|Analysis of time to first severe exacerbation within 30 days of treatment start.|
1614474|NCT02491684|2963266|Superiority or Other||Ratio of proportions|1.1||||0.944|2-Sided|95.0|0.08|15.79|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 30|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.|
1614475|NCT02491684|2963266|Superiority or Other||Ratio of proportions|1.1||||0.944|2-Sided|95.0|0.08|15.79|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 14|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.|
1614476|NCT02491684|2963267|Superiority or Other||Ratio of proportions|1.25||||0.659|2-Sided|95.0|0.46|3.41|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 30|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.|
1614477|NCT02491684|2963267|Superiority or Other||Ratio of proportions|1.97||||0.411|2-Sided|95.0|0.39|9.89|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo for Days 1 - 7|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.|
1614478|NCT02491684|2963268|Superiority or Other||Ratio of proportions|1.29||||0.645|2-Sided|95.0|0.43|3.85|||log-binomial regression model|The ratio of proportions was calculated by back-transforming the estimated treatment effect.|AZD9412 versus Placebo|Proportions of patients with exacerbations are compared using a log-binomial regression model with treatment group and region as factors.|
1614479|NCT02491073|2963315|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||2-Sided|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|
1614480|NCT02491073|2963315|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||2-Sided|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614481|NCT02491073|2963315|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||2-Sided|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value -0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614482|NCT02491073|2963316|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.19|||||2-Sided|90.0|1.11|1.27|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.215|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator
1614483|NCT02491073|2963316|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.19|||||2-Sided|90.0|1.12|1.27|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.203|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator
1614484|NCT02491073|2963316|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.42|||||2-Sided|90.0|1.33|1.52|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.224|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator
1614485|NCT02491073|2963316|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.21|||||2-Sided|90.0|1.15|1.52|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.178|FT3|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator
1614486|NCT02491073|2963316|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.04|||||2-Sided|90.0|0.99|1.1|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.179|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.
1614487|NCT02491073|2963316|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.11|||||2-Sided|90.0|1.04|1.18|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.203|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.
1614488|NCT02491073|2963316|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.13|||||2-Sided|90.0|1.07|1.2|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.202|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator
1614564|NCT02485561|2963724|Superiority||F-value|6.482|||<|0.002|2-Sided||||||ANOVA||||
1614489|NCT02491073|2963316|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.11|||||2-Sided|90.0|1.06|1.16|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.148|FT4|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator
1614490|NCT02491073|2963317|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|0.99|||||2-Sided|90.0|0.97|1.0|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.048|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614491|NCT02491073|2963317|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||2-Sided|90.0|0.98|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.043|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614492|NCT02491073|2963317|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|0.99|||||2-Sided|90.0|0.98|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.047|TT3|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614493|NCT02491073|2963317|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||2-Sided|90.0|0.99|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.036|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614494|NCT02491073|2963317|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Slope|1.01|||||2-Sided|90.0|1.0|1.02|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.033|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614495|NCT02491073|2963317|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric mean ratio|1.0|||||2-Sided|90.0|0.99|1.02|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|TT4|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator.
1614496|NCT02491073|2963317|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||2-Sided|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|
1614497|NCT02491073|2963317|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||2-Sided|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614498|NCT02491073|2963317|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||2-Sided|90.0|1.0|1.01|||||parameter dispersion type - geometric coefficient of variation dispersion value -0.018|TSH|In each geometric mean ratio estimate, thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614499|NCT02491073|2963318|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.03|||||2-Sided|90.0|1.02|1.04|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614516|NCT02489279|2963409|Superiority|||||||0.00018|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.|
1615540|NCT02451839|2966004|Superiority||||||<|0.001|||||||paired t-test||||
1614500|NCT02491073|2963318|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geotmetric mean ratio|1.02|||||2-Sided|90.0|1.0|1.03|||||parameter dispersion type - geometric coefficient of variation dispersion value - 0.041|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614501|NCT02491073|2963318|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.0|||||2-Sided|90.0|0.99|1.02|||||parameter dispersion type -geometric coefficient of variation dispersion value - 0.040|FT3|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614502|NCT02491073|2963318|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|geometric mean ratio|1.05|||||2-Sided|90.0|1.05|1.06|||||parameter dispersion type - geometric coefficient variation dispersion value - 0.021|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614503|NCT02491073|2963318|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric Mean Ratio|1.03|||||2-Sided|90.0|1.03|1.04|||||parameter dispersion value - geometric coefficient of variation dispersion value - 0.020|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614504|NCT02491073|2963318|Other|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|Geometric Mean Ratio|1.01|||||2-Sided|90.0|1.01|1.03|||||Parameter dispersion type: geometric coefficient of variation dispersion value 0.024|FT4|In each geometric mean ratio estimate, free thyroid hormone levels in the spiked serum samples (LS or MS or HS) represent the numerator; free thyroid hormone levels in non-spiked serum samples (NS) represent the denominator
1614505|NCT02491073|2963319|Other||Geometric Mean Ratio|1.15|||||2-Sided|90.0|1.09|1.22|||||parameter dispersion type: Geometric Coefficient of Variation Dispersion Value : FT3: 0.178|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.
1614506|NCT02491073|2963319|Other||geometric mean ratio|1.05||||1.05|2-Sided|90.0|0.98|1.09|||geometric mean ration||The parameter dispersion type:Geometric coefficient of variation Dispersion Value: FT4: 0.220|There is no hypothesis testing in this study. The sample size was determined outside of statistical considerations; it was required by the U.S. Food and Drug Administration (FDA) in the New Drug Application 022416 Approval Letter issued on 08 November 2013 for PMR 2099-9.|In each geometric mean ratio estimate, free thyroid hormone levels as measured by the automated kit assay represent the numerator; free thyroid hormone levels as measured by the optimized equilibrium dialysis method represent the denominator.
1614507|NCT02490631|2963322|Superiority|||||||0.019|||||||Chi-squared||||
1614508|NCT02490631|2963323|Superiority|||||||0.456|||||||Chi-squared||||
1614509|NCT02489968|2963351|Superiority or Other||Adjusted mean difference|-0.59|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|-0.73|-0.45|||REML based MMRM|Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.|Adjusted mean difference: Change in HbA1c in (empagliflozin 25 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 25 mg + placebo)||
1614510|NCT02489968|2963351|Superiority or Other||Adjusted mean difference|-0.82|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.97|-0.67|||REML based MMRM|Model including baseline HbA1c, treatment, baseline renal function, prior use of antidiabetic drug, visit, and visit by treatment interaction.|Adjusted mean difference: Change in HbA1c in (empagliflozin 10 mg + linagliptin 5 mg) - change in HbA1c in (empagliflozin 10 mg + placebo)||
1614511|NCT02489799|2963360|Equivalence|The study was powered based on two former studies utilizing RIAS, (both powered =.8 and alpha =.05). With a 0.6 effect size, the required sample size is 72 patients (36 per group) for a one-tailed test of study hypotheses (power =.8 and alpha =.05).|Incidence Rate Ratio|1.06||||0.545|2-Sided|95.0|0.87|1.3|||Poisson model using GEE|We fit a Poisson model using generalized estimating equations. No adjustments were made for degrees of freedom.|The incidence rate ratio compares intervention to control.|We employed two ways of interpreting this data. The first treats the outcome continuously, which is described in the results section. Here we describe the outcome treating it as a ratio. We created a variable representing the numerator of the ratio (type 1) and the denominator of the ratio (type 2) thereby treating the information in both the numerator and denominator as random (each a Poisson variable).|
1614512|NCT02489773|2963362|Other|The difference in Kendall correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.|Difference in correlation coefficient|0.181|||<|0.0001|2-Sided|95.0|0.096|0.265|||t-test, 2 sided||||
1614513|NCT02489773|2963363|Other|The difference in Spearman correlation coefficient between GA and MBG vs HbA1c and MBG in the first 3-month period in Group 1.|Difference in correlation coefficients|0.249|||<|0.0001|2-Sided|95.0|0.13|0.364|||t-test, 2 sided||||
1614514|NCT02489773|2963364|Other|Diffenrence between Pearson correlations within whole subjects (accross Group 1 and Group 2) and PG, 0.8.|Difference with PG 0.8|-0.1658|||>|0.9999|2-Sided|95.0|-0.2204|-0.1113|||t-test, 2 sided||||
1614517|NCT02489279|2963410|Superiority|||||||1e-06|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report only a main effect of Time.|
1614518|NCT02489279|2963411|Superiority|||||||0.21|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.|
1614519|NCT02489279|2963411|Superiority|||||||0.0005|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.|
1614520|NCT02489279|2963411|Superiority|||||||0.014|||||||GLM with repeated measures ANOVA|||We used a GLM with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.|
1614521|NCT02489279|2963412|Superiority|||||||0.25|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.|
1614522|NCT02489279|2963412|Superiority|||||||0.0075|||||||t-test, 1 sided|||We then examined the within-subjects factor of Time (Post-Treatment (10 week measure) - Baseline), for each Group, using a 1-tailed t test.|
1614523|NCT02489279|2963412|Superiority|||||||0.026|||||||GLM with repeated measures ANOVA|||We used a General Linear Model (GLM) with time (Baseline and 10 Weeks) as the within subjects factor, experimental group (Active and Control) as the between subjects factor, and a group by time interaction to test for differential treatment effects. We report the Group x Time interaction.|
1614524|NCT02488239|2963445|Other||||||<|0.001|||||||t-test, 1 sided||||
1614525|NCT02488239|2963446|Other||||||<|0.001|||||||exact binomial rate||||
1614526|NCT02488018|2963452|Superiority or Other||||||<|0.01|||||||ANOVA|Degree of freedom for the model (treatment) was 8.||Hypothesis Ho: Honey plant origin does not affects the glycemic index of human subjects. Ha: Honey plant origin affects the glycemic index of human subjects.|
1614527|NCT02487498|2963560|Superiority or Other||Mean Difference (Net)|0.0086|Standard Error of the Mean|0.00874|||2-Sided|95.0|-0.0086|0.0258|||||||
1614528|NCT02487498|2963561|Superiority or Other||Mean Difference (Net)|-0.0091|Standard Error of the Mean|0.01132|||2-Sided|95.0|-0.0313|0.0131|||||||
1614529|NCT02487498|2963562|Superiority or Other||Mean Difference (Net)|-0.0182|Standard Error of the Mean|0.00813|||2-Sided|95.0|-0.0342|-0.0023|||||||
1614530|NCT02487498|2963563|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the lower limit (LL) of the 97.5% one -sided confidence interval (CI) > –20 mL|Mean Difference (Net)|-0.0182|Standard Error of the Mean|0.00813||0.415|2-Sided|95.0|-0.0342|-0.0023|||Linear Mixed Model|||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.|
1614531|NCT02487446|2963578|Superiority or Other||Mean Difference (Net)|0.0051|Standard Error of the Mean|0.00806|||2-Sided|95.0|-0.0108|0.0209|||||||
1614532|NCT02487446|2963579|Superiority or Other||Mean Difference (Net)|-0.0153|Standard Error of the Mean|0.01062|||2-Sided|95.0|-0.0361|0.0056|||||||
1614533|NCT02487446|2963580|Superiority or Other||Mean Difference (Net)|-0.0115|Standard Error of the Mean|0.00778|||2-Sided|95.0|-0.0269|0.0038||||||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.|
1614534|NCT02487446|2963581|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the lower limit (LL) of the 97.5% one -sided confidence interval (CI) > –20 mL.|Mean Difference (Net)|-0.0115|Standard Error of the Mean|0.00778||0.139|2-Sided|95.0|-0.0269|0.0038||p-value unadjusted|Linear Mixed Model|||Ho: QVA149 27.5/12.5 μg b.i.d. is inferior to umeclidinium/vilanterol 62.5/25 μg q.d; Ha: QVA149 27.5/12.5 μg b.i.d. is non-inferior to umeclidinium/vilanterol 62.5/25 μg q.d.|
1614535|NCT02487225|2963592|Superiority|||||||0.3173|||||||Kruskal-Wallis|||Day 5|
1614536|NCT02487225|2963592|Superiority|||||||0.157|||||||Kruskal-Wallis|||Admission (baseline)|
1614537|NCT02487225|2963593|Superiority|||||||0.9468|||||||Kruskal-Wallis|||Day 5|
1614538|NCT02487225|2963593|Superiority|||||||0.1236|||||||Kruskal-Wallis|||Admission (baseline)|
1614539|NCT02487225|2963594|Superiority|||||||0.4619|||||||Kruskal-Wallis||||
1614540|NCT02487225|2963594|Superiority|||||||0.1109|||||||Kruskal-Wallis|||Admission (baseline)|
1614541|NCT02487225|2963595|Superiority|||||||0.8415|||||||Kruskal-Wallis|||Day 5|
1614542|NCT02487225|2963595|Superiority|||||||0.5796|||||||Kruskal-Wallis|||Admission (baseline)|
1614543|NCT02486627|2963636|Non-Inferiority|95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.|Difference|11.6|||||2-Sided|95.0|2.7|20.3|||||||
1614544|NCT02486627|2963637|Non-Inferiority|95% CIs for the difference in cure rates were calculated using the Newcombe method with continuity correction.|Difference|-3.4|||||2-Sided|95.0|-10.0|3.1|||||||
1614545|NCT02485925|2963699|Other||Proportion of participants|99.5|||||2-Sided|95.0|97.2|100.0|||||||95% confidence interval is based on Clopper-Pearson confidence interval
1614546|NCT02485925|2963700|Other||Proportion of participants|80.7|||||2-Sided|95.0|73.9|86.4|||||||95% confidence interval is based on Clopper-Pearson confidence interval
1614547|NCT02485561|2963717|Superiority||F-value|0.056||||0.95|2-Sided||||||ANOVA||||
1614548|NCT02485561|2963717|Superiority||F-value|1.17||||0.31|2-Sided||||||ANOVA||||
1614549|NCT02485561|2963718|Superiority||F-value|1.16||||0.31|2-Sided||||||ANOVA||||
1614550|NCT02485561|2963719|Superiority||F-value|0.18||||0.84|2-Sided||||||ANOVA||||
1614551|NCT02485561|2963720|Superiority||F-value|0.59||||0.56|2-Sided||||||ANOVA||||
1614552|NCT02485561|2963721|Superiority||F-value|0.666||||0.514|2-Sided||||||ANOVA||||
1614553|NCT02485561|2963721|Superiority||F-value|0.667||||0.514|2-Sided||||||ANOVA||||
1614554|NCT02485561|2963721|Superiority||F-value|1.88||||0.154|2-Sided||||||ANOVA||||
1614555|NCT02485561|2963721|Superiority||F-value|0.702||||0.496|2-Sided||||||ANOVA||||
1614556|NCT02485561|2963721|Superiority||F-value|0.312||||0.73|2-Sided||||||ANOVA||||
1614557|NCT02485561|2963721|Superiority||F-value|0.021||||0.98|2-Sided||||||ANOVA||||
1614565|NCT02485561|2963725|Superiority||Mean Difference (Final Values)|-0.024|Standard Error of the Mean|0.074||0.75|2-Sided||||||t-test, 2 sided||||
1614566|NCT02485561|2963725|Superiority||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.098||0.024|2-Sided||||||t-test, 2 sided||||
1614567|NCT02485561|2963726|Superiority||F-value|1.019||||0.362|2-Sided||||||ANOVA||||
1614568|NCT02485483|2963732|Superiority or Other||Spearman correlation coefficient|-0.77|||<|0.001|2-Sided|95.0|-0.82|-0.7||"Convergent Validity Criterion ρ > |0.50|"|t-test, 2 sided||Convergent correlation between WHO-5 and PHQ-9|Number of participants analyzed (N) = 205|
1614569|NCT02485483|2963732|Superiority or Other||Spearman correlation coefficient|-0.68|||<|0.001|2-Sided|95.0|-0.75|-0.6||"Convergent Validity Criterion ρ > |0.50|"|t-test, 2 sided||Convergent correlation between WHO-5 and BDI-II|Number of participants analyzed (N) = 199|
1614570|NCT02485483|2963732|Superiority or Other||Spearman correlation coefficient|-0.54|||<|0.219|2-Sided|95.0|-0.63|-0.43||"Convergent Validity Criterion ρ > |0.50|"|t-test, 2 sided||Convergent correlation between WHO-5 and MADRS|Number of participants analyzed (N) = 202|
1614571|NCT02485483|2963733|Superiority or Other||Spearman correlation coefficient|-0.73|||<|0.001|2-Sided|95.0|-0.78|-0.66||"Convergent Validity Criterion ρ > |0.50|"|t-test, 2 sided||Convergent correlation between WHO-5 and PHQ-9|Number of participants analyzed (N) = 222|
1614572|NCT02485483|2963733|Superiority or Other||Spearman correlation coefficient|-0.61|||<|0.01|2-Sided|95.0|-0.68|-0.52||"Convergent Validity Criterion ρ > |0.50|"|t-test, 2 sided||Convergent correlation between WHO-5 and BDI-II|Number of participants analyzed (N) = 223|
1614573|NCT02485483|2963733|Superiority or Other||Spearman correlation coefficient|-0.59|||<|0.034|2-Sided|95.0|-0.67|-0.49||"Convergent Validity Criterion ρ > |0.50|"|t-test, 2 sided||Convergent correlation between WHO-5 and MADRS|Number of participants analyzed (N) = 222|
1614574|NCT02485483|2963734|Superiority or Other||Spearman correlation coefficient|0.71|||<|0.001|2-Sided|95.0|0.64|0.77||"Convergent Validity Criterion ρ > |0.50|"|t-test, 2 sided||Convergent correlation between BDI-II and MADRS|Number of participants analyzed (N) = 214|
1614575|NCT02485483|2963735|Superiority or Other||Spearman correlation coefficient|0.73|||<|0.001|2-Sided|95.0|0.67|0.79||"Convergent Validity Criterion ρ > |0.50|"|t-test, 2 sided||Convergent correlation between BDI-II and MADRS|Number of participants analyzed (N) = 258|
1614576|NCT02485483|2963736|Superiority or Other||Spearman correlation coefficient|0.74|||<|0.001|2-Sided|95.0|0.67|0.8||"Convergent Validity Criterion ρ > |0.50|"|t-test, 2 sided||Convergent correlation between PHQ-9 and BDI-II|Number of participants analyzed (N) = 200|
1614577|NCT02485483|2963736|Superiority or Other||Spearman correlation coefficient|0.58|||<|0.057|2-Sided|95.0|0.48|0.66||"Convergent Validity Criterion ρ > |0.50|"|t-test, 2 sided||Convergent correlation between PHQ-9 and MADRS|Number of participants analyzed (N) = 203|
1614578|NCT02485483|2963737|Superiority or Other||Spearman correlation coefficient|0.69|||<|0.001|2-Sided|95.0|0.62|0.76||"Convergent Validity Criterion ρ > |0.50|"|t-test, 2 sided||Convergent correlation between PHQ-9 and BDI-II|Number of participants analyzed (N) = 222|
1614579|NCT02485483|2963737|Superiority or Other||Spearman correlation coefficient|0.67|||<|0.001|2-Sided|95.0|0.59|0.74||"Convergent Validity Criterion Correlation coefficient (ρ) > |0.50|"|t-test, 2 sided||Convergent correlation between PHQ-9 and MADRS|Number of participants analyzed (N) = 221|
1614580|NCT02484911|2963777|Superiority or Other|||||||0.246|||||||Chi-squared||||
1614581|NCT02484911|2963778|Superiority or Other|||||||1|||||||Chi-squared||||
1614582|NCT02484911|2963779|Superiority or Other|||||||0.283|||||||Chi-squared||||
1614583|NCT02484911|2963780|Superiority or Other|||||||1|||||||Chi-squared||||
1614584|NCT02484911|2963782|Superiority or Other|||||||0.005|||||||Chi-squared||||
1614585|NCT02484911|2963783|Superiority or Other|||||||1|||||||Chi-squared||||
1614586|NCT02484911|2963784|Superiority or Other|||||||0.02|||||||Chi-squared||||
1614587|NCT02484911|2963785|Superiority or Other|||||||0.397|||||||Chi-squared||||
1614588|NCT02484911|2963787|Superiority or Other|||||||1|||||||Chi-squared||||
1614589|NCT02484911|2963788|Superiority or Other|||||||0.397|||||||Chi-squared||||
1614590|NCT02484859|2963790|Superiority|||||||0.47|||||||Chi-squared||||
1614591|NCT02484859|2963791|Superiority|||||||0.55|||||||Chi-squared|||Null hypothesis was that the visual analog pain scores (VAS) of patients at discharge from post anesthetic care unit (PACU) were similar.|
1614592|NCT02484859|2963791|Superiority|||||||0.05|||||||Chi-squared|||Null hypothesis was that the visual analog pain scores (VAS) of patients at arrrival to post anesthetic care unit (PACU) were similar.|
1614593|NCT02484859|2963792|Superiority|||||||0.052|||||||t-test, 2 sided||||
1614594|NCT02484859|2963793|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1614595|NCT02484859|2963794|Superiority||||||>|0.69|||||||Wilcoxon (Mann-Whitney)|||Median intraoperative bleeding scores were compared with Wilcoxon test. In this pilot study the power analysis showed that a sample size of 44 patients in each group was sufficient to detect a difference of 0.2 in the mean (standard deviation of 0.4) with an 80% power with an alpha error of 0.05 and a beta error of 20%. The Shapiro-Wilk test was used to test the distribution of data.|
1614596|NCT02484651|2963821|Superiority|||||||0.669|||||||Chi-squared|||The null hypothesis was that PQRS satisfaction with anesthetic care was independent of the study group.|
1614597|NCT02484651|2963822|Superiority|||||||0.107|||||||Fisher Exact|||The null hypothesis was that PQRS overall recovery at 40 minutes was independent from the study group.|
1614598|NCT02484651|2963822|Superiority|||||||0.419|||||||Fisher Exact|||The null hypothesis was that PQRS overall recovery at 15 minutes was independent from the study group.|
1614599|NCT02484651|2963823|Superiority|||||||0.245|||||||t-test, 2 sided|||"This statistical analysis applies to the remifentanil effect-site concentration.~Sample size calculation was performed with a power of 0.80 and an α of 0.05 also a reduction in the remifentanil drug consumption (measured as the average effect-site concentration) during maintenance of anesthesia. A reduction on on remifentanil average effect-site concentration of 20% was considered clinically relevant, giving a minimum of 24 patients per group"|
1614638|NCT02483611|2963861|Superiority or Other||Median Difference (Final Values)|63.5||||0.1406|2-Sided|95.0|55.0|86.0|||Kruskal-Wallis||||
1614600|NCT02484651|2963823|Superiority||||||<|0.001|||||||t-test, 2 sided|||This statistical analysis applies to the propofol effect-site concentration. Sample size calculation was performed with a power of 0.80 and an α of 0.05 also a reduction in the propofol drug consumption (measured as the average effect-site concentration) during maintenance of anesthesia. A reduction on propofol mean effect-site concentration of 20% was considered clinically relevant, giving a minimum of 34 patients per group|
1614601|NCT02484651|2963824|Superiority|||||||0.651|||||||t-test, 2 sided|||Sample size calculation was performed with a power of 0.80 and an α of 0.05, considering the primary hypothesis of a reduction in the BIS variability (measured as the standard deviation). A 25% reduction on the BIS variability (standard deviation) was considered clinically relevant, and gave a minimum sample size of 26 per group.|
1614602|NCT02483975|2963839|Superiority or Other (legacy)||Least square Geometric Mean ratio|0.88|||||2-Sided|95.0|0.72|1.07|||||||
1614603|NCT02483975|2963840|Superiority or Other (legacy)||Least square Geometric Mean ratio|0.79|||||2-Sided|95.0|0.61|1.03|||||||
1614604|NCT02483975|2963841|Superiority or Other (legacy)||Least square Geometric Mean ratio|0.93|||||2-Sided|95.0|0.81|1.06|||||||
1614605|NCT02483975|2963842|Non-Inferiority or Equivalence (legacy)|Non inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of each dose of fluticasone furoate 50 µg versus placebo was greater than 0.8.|Least square Geometric Mean ratio|0.93|||||2-Sided|95.0|0.8096|1.062|||||||
1614606|NCT02483975|2963843|Non-Inferiority or Equivalence (legacy)|Non inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of each dose of fluticasone furoate 50 µg versus placebo was greater than 0.8.|Least square Geometric Mean ratio|0.92|||||2-Sided|95.0|0.804|1.0505|||||||
1614607|NCT02483611|2963851|Superiority or Other||Median Difference (Final Values)|61.0||||0.7723|2-Sided|95.0|50.0|78.0|||Kruskal-Wallis||||
1614608|NCT02483611|2963851|Superiority or Other||Median Difference (Final Values)|61.0||||0.7723|2-Sided|95.0|51.0|82.0|||Kruskal-Wallis||||
1614609|NCT02483611|2963851|Superiority or Other||Median Difference (Final Values)|66.0||||0.7723|2-Sided|95.0|43.0|89.0|||Kruskal-Wallis||||
1614610|NCT02483611|2963852|Superiority or Other||Median Difference (Final Values)|58.0||||0.4988|2-Sided|95.0|51.0|80.0|||Kruskal-Wallis||||
1614611|NCT02483611|2963852|Superiority or Other||Median Difference (Final Values)|63.0||||0.4988|2-Sided|95.0|50.0|85.0|||Kruskal-Wallis||||
1614612|NCT02483611|2963852|Superiority or Other||Median Difference (Final Values)|66.5||||0.4988|2-Sided|95.0|42.0|92.0|||Kruskal-Wallis||||
1614613|NCT02483611|2963853|Superiority or Other||Mean Difference (Final Values)|61.93|Standard Deviation|9.0||0.5351|2-Sided|95.0|51.0|79.0|||ANOVA||||
1614614|NCT02483611|2963853|Superiority or Other||Mean Difference (Final Values)|65.31|Standard Deviation|10.87||0.5351|2-Sided|95.0|47.0|82.0|||ANOVA||||
1614615|NCT02483611|2963853|Superiority or Other||Mean Difference (Final Values)|66.19|Standard Deviation|12.82||0.5351|2-Sided|95.0|45.0|92.0|||ANOVA||||
1614616|NCT02483611|2963854|Superiority or Other||Mean Difference (Final Values)|62.33|Standard Deviation|9.26||0.5796|2-Sided|95.0|50.0|79.0|||ANOVA||||
1614617|NCT02483611|2963854|Superiority or Other||Mean Difference (Final Values)|65.75|Standard Deviation|10.19||0.5796|2-Sided|95.0|48.0|79.0|||ANOVA||||
1614618|NCT02483611|2963854|Superiority or Other||Mean Difference (Final Values)|65.75|Standard Deviation|11.52||0.5796|2-Sided|95.0|47.0|93.0|||ANOVA||||
1614619|NCT02483611|2963855|Superiority or Other||Mean Difference (Final Values)|64.0|Standard Deviation|8.23||0.4195|2-Sided|95.0|52.0|80.0|||ANOVA||||
1614620|NCT02483611|2963855|Superiority or Other||Mean Difference (Final Values)|68.38|Standard Deviation|9.28||0.4195|2-Sided|95.0|53.0|80.0|||ANOVA||||
1614621|NCT02483611|2963855|Superiority or Other||Mean Difference (Final Values)|67.44|Standard Deviation|10.95||0.4195|2-Sided|95.0|47.0|92.0|||ANOVA||||
1614622|NCT02483611|2963856|Superiority or Other||Mean Difference (Final Values)|73.4|Standard Deviation|7.94||0.8746|2-Sided|95.0|54.0|80.0|||ANOVA||||
1614623|NCT02483611|2963856|Superiority or Other||Mean Difference (Final Values)|64.38|Standard Deviation|6.96||0.8746|2-Sided|95.0|56.0|82.0|||ANOVA||||
1614624|NCT02483611|2963856|Superiority or Other||Mean Difference (Final Values)|68.67|Standard Deviation|8.51||0.8746|2-Sided|95.0|51.0|99.0|||ANOVA||||
1614625|NCT02483611|2963857|Superiority or Other||Median Difference (Final Values)|72.0||||0.0178|2-Sided|95.0|61.0|91.0|||Kruskal-Wallis||||
1614626|NCT02483611|2963857|Superiority or Other||Median Difference (Final Values)|64.5||||0.0178|2-Sided|95.0|51.0|75.0|||Kruskal-Wallis||||
1614627|NCT02483611|2963857|Superiority or Other||Median Difference (Final Values)|64.0||||0.0178|2-Sided|95.0|60.0|84.0|||Kruskal-Wallis||||
1614628|NCT02483611|2963858|Superiority or Other||Median Difference (Final Values)|69.0||||0.3004|2-Sided|95.0|62.0|81.0|||Kruskal-Wallis||||
1614629|NCT02483611|2963858|Superiority or Other||Median Difference (Final Values)|66.0||||0.3004|2-Sided|95.0|56.0|78.0|||Kruskal-Wallis||||
1614630|NCT02483611|2963858|Superiority or Other||Median Difference (Final Values)|68.0||||0.3004|2-Sided|95.0|58.0|86.0|||Kruskal-Wallis||||
1614631|NCT02483611|2963859|Superiority or Other||Median Difference (Final Values)|66.0||||0.0205|2-Sided|95.0|59.0|75.0|||Kruskal-Wallis||||
1614632|NCT02483611|2963859|Superiority or Other||Median Difference (Final Values)|62.0||||0.0205|2-Sided|95.0|54.0|72.0|||Kruskal-Wallis||||
1614633|NCT02483611|2963859|Superiority or Other||Median Difference (Final Values)|68.0||||0.0205|2-Sided|95.0|60.0|93.0|||Kruskal-Wallis||||
1614634|NCT02483611|2963860|Superiority or Other||Mean Difference (Final Values)|69.0|Standard Deviation|7.56||0.0504|2-Sided|95.0|58.0|84.0|||ANOVA||||
1614635|NCT02483611|2963860|Superiority or Other||Mean Difference (Final Values)|63.0|Standard Deviation|7.62||0.0504|2-Sided|95.0|49.0|79.0|||ANOVA||||
1614636|NCT02483611|2963860|Superiority or Other||Mean Difference (Final Values)|69.25|Standard Deviation|6.74||0.0504|2-Sided|95.0|60.0|81.0|||ANOVA||||
1614637|NCT02483611|2963861|Superiority or Other||Median Difference (Final Values)|68.0||||0.1406|2-Sided|95.0|55.0|84.0|||Kruskal-Wallis||||
1614849|NCT02478359|2964208|Superiority||Odds Ratio (OR)|0.96||||0.8|2-Sided|95.0|0.68|1.35|||Regression, Logistic||||
1614639|NCT02483611|2963861|Superiority or Other||Median Difference (Final Values)|66.5||||0.1406|2-Sided|95.0|60.0|88.0|||Kruskal-Wallis||||
1614640|NCT02483611|2963862|Superiority or Other||Median Difference (Final Values)|69.0||||0.0937|2-Sided|95.0|58.0|87.0|||Kruskal-Wallis||||
1614641|NCT02483611|2963862|Superiority or Other||Median Difference (Final Values)|61.5||||0.0937|2-Sided|95.0|56.0|90.0|||Kruskal-Wallis||||
1614642|NCT02483611|2963862|Superiority or Other||Median Difference (Final Values)|66.0||||0.0937|2-Sided|95.0|58.0|80.0|||Kruskal-Wallis||||
1614643|NCT02483611|2963863|Superiority or Other||Mean Difference (Final Values)|65.13|Standard Deviation|10.5||0.6817|2-Sided|95.0|47.0|81.0|||ANOVA||||
1614644|NCT02483611|2963863|Superiority or Other||Mean Difference (Final Values)|68.19|Standard Deviation|8.4||0.6817|2-Sided|95.0|54.0|82.0|||ANOVA||||
1614645|NCT02483611|2963863|Superiority or Other||Mean Difference (Final Values)|66.5|Standard Deviation|10.11||0.6817|2-Sided|95.0|53.0|92.0|||ANOVA||||
1614646|NCT02483611|2963864|Superiority or Other||Mean Difference (Final Values)|64.27|Standard Deviation|10.81||0.3423|2-Sided|95.0|41.0|81.0|||ANOVA||||
1614647|NCT02483611|2963864|Superiority or Other||Mean Difference (Final Values)|69.31|Standard Deviation|7.73||0.3423|2-Sided|95.0|57.0|83.0|||ANOVA||||
1614648|NCT02483611|2963864|Superiority or Other||Mean Difference (Final Values)|67.56|Standard Deviation|10.05||0.3423|2-Sided|95.0|56.0|92.0|||ANOVA||||
1614649|NCT02483611|2963865|Superiority or Other||Mean Difference (Final Values)|65.07|Standard Deviation|10.01||0.1015|2-Sided|95.0|44.0|81.0|||ANOVA||||
1614650|NCT02483611|2963865|Superiority or Other||Mean Difference (Final Values)|72.25|Standard Deviation|9.78||0.1015|2-Sided|95.0|52.0|89.0|||ANOVA||||
1614651|NCT02483611|2963865|Superiority or Other||Mean Difference (Final Values)|71.94|Standard Deviation|10.87||0.1015|2-Sided|95.0|57.0|93.0|||ANOVA||||
1614652|NCT02483611|2963866|Superiority or Other||Mean Difference (Final Values)|75.4|Standard Deviation|11.54||0.8067|2-Sided|95.0|53.0|90.0|||ANOVA||||
1614653|NCT02483611|2963866|Superiority or Other||Mean Difference (Final Values)|74.19|Standard Deviation|8.65||0.8067|2-Sided|95.0|57.0|86.0|||ANOVA||||
1614654|NCT02483611|2963866|Superiority or Other||Mean Difference (Final Values)|72.94|Standard Deviation|10.96||0.8067|2-Sided|95.0|58.0|92.0|||ANOVA||||
1614655|NCT02483611|2963867|Superiority or Other||Mean Difference (Final Values)|75.4|Standard Deviation|11.54||0.9167|2-Sided|95.0|53.0|90.0|||ANOVA||||
1614656|NCT02483611|2963867|Superiority or Other||Mean Difference (Final Values)|73.69|Standard Deviation|11.18||0.9167|2-Sided|95.0|51.0|96.0|||ANOVA||||
1614657|NCT02483611|2963867|Superiority or Other||Mean Difference (Final Values)|74.69|Standard Deviation|11.76||0.9167|2-Sided|95.0|57.0|99.0|||ANOVA||||
1614658|NCT02483611|2963868|Superiority or Other||Mean Difference (Final Values)|73.67|Standard Deviation|11.82||0.4338|2-Sided|95.0|55.0|92.0|||ANOVA||||
1614659|NCT02483611|2963868|Superiority or Other||Mean Difference (Final Values)|77.25|Standard Deviation|12.13||0.4338|2-Sided|95.0|55.0|95.0|||ANOVA||||
1614660|NCT02483611|2963868|Superiority or Other||Mean Difference (Final Values)|79.94|Standard Deviation|15.79||0.4338|2-Sided|95.0|52.0|109.0|||ANOVA||||
1614661|NCT02483611|2963869|Superiority or Other||Median Difference (Final Values)|69.0||||0.1002|2-Sided|95.0|60.0|90.0|||Kruskal-Wallis||||
1614662|NCT02483611|2963869|Superiority or Other||Median Difference (Final Values)|64.0||||0.1002|2-Sided|95.0|56.0|74.0|||Kruskal-Wallis||||
1614663|NCT02483611|2963869|Superiority or Other||Median Difference (Final Values)|64.5||||0.1002|2-Sided|95.0|60.0|85.0|||Kruskal-Wallis||||
1614664|NCT02483611|2963870|Superiority or Other||Median Difference (Final Values)|67.0||||0.0731|2-Sided|95.0|56.0|85.0|||Kruskal-Wallis||||
1614665|NCT02483611|2963870|Superiority or Other||Median Difference (Final Values)|61.5||||0.0731|2-Sided|95.0|55.0|74.0|||Kruskal-Wallis||||
1614666|NCT02483611|2963870|Superiority or Other||Median Difference (Final Values)|62.5||||0.0731|2-Sided|95.0|58.0|98.0|||Kruskal-Wallis||||
1614667|NCT02483611|2963871|Superiority or Other||Median Difference (Final Values)|74.0||||0.113|2-Sided|95.0|59.0|83.0|||Kruskal-Wallis||||
1614668|NCT02483611|2963871|Superiority or Other||Median Difference (Final Values)|63.0||||0.113|2-Sided|95.0|55.0|84.0|||Kruskal-Wallis||||
1614669|NCT02483611|2963871|Superiority or Other||Median Difference (Final Values)|69.0||||0.113|2-Sided|95.0|57.0|96.0|||Kruskal-Wallis||||
1614670|NCT02483611|2963872|Superiority or Other||Mean Difference (Final Values)|76.73|Standard Deviation|7.48||0.7145|2-Sided|95.0|58.0|86.0|||ANOVA||||
1614671|NCT02483611|2963872|Superiority or Other||Mean Difference (Final Values)|73.88|Standard Deviation|9.8||0.7145|2-Sided|95.0|59.0|97.0|||ANOVA||||
1614672|NCT02483611|2963872|Superiority or Other||Mean Difference (Final Values)|75.88|Standard Deviation|11.95||0.7145|2-Sided|95.0|58.0|107.0|||ANOVA||||
1614673|NCT02483611|2963873|Superiority or Other||Mean Difference (Final Values)|92.47|Standard Deviation|12.3||0.1996|2-Sided|95.0|73.0|112.0|||ANOVA||||
1614674|NCT02483611|2963873|Superiority or Other||Mean Difference (Final Values)|84.69|Standard Deviation|11.38||0.1996|2-Sided|95.0|67.0|109.0|||ANOVA||||
1614675|NCT02483611|2963873|Superiority or Other||Mean Difference (Final Values)|87.63|Standard Deviation|12.1||0.1996|2-Sided|95.0|60.0|110.0|||ANOVA||||
1614676|NCT02483611|2963874|Superiority or Other||Mean Difference (Final Values)|100.1|Standard Deviation|16.62||0.0527|2-Sided|95.0|70.0|140.0|||ANOVA||||
1614677|NCT02483611|2963874|Superiority or Other||Mean Difference (Final Values)|88.75|Standard Deviation|10.05||0.0527|2-Sided|95.0|65.0|104.0|||ANOVA||||
1614678|NCT02483611|2963874|Superiority or Other||Mean Difference (Final Values)|94.63|Standard Deviation|10.18||0.0527|2-Sided|95.0|70.0|112.0|||ANOVA||||
1614679|NCT02483611|2963875|Superiority or Other||Mean Difference (Final Values)|90.03|Standard Deviation|12.78|<|0.0001|2-Sided|95.0|71.75|116.4|||ANOVA||||
1614680|NCT02483611|2963875|Superiority or Other||Mean Difference (Final Values)|126.7|Standard Deviation|14.19|<|0.0001|2-Sided|95.0|106.5|149.4|||ANOVA||||
1615541|NCT02451839|2966005|Superiority||||||<|0.001|||||||paired t-test||||
1614681|NCT02483611|2963875|Superiority or Other||Mean Difference (Final Values)|120.2|Standard Deviation|10.88|<|0.0001|2-Sided|95.0|106.3|140.2|||ANOVA||||
1614682|NCT02483611|2963876|Superiority or Other||Mean Difference (Final Values)|88.19|Standard Deviation|16.34|<|0.0001|2-Sided|95.0|58.0|125.2|||ANOVA||||
1614683|NCT02483611|2963876|Superiority or Other||Mean Difference (Final Values)|120.1|Standard Deviation|18.2|<|0.0001|2-Sided|95.0|95.82|163.3|||ANOVA||||
1614684|NCT02483611|2963876|Superiority or Other||Mean Difference (Final Values)|113.2|Standard Deviation|12.16|<|0.0001|2-Sided|95.0|94.87|136.8|||ANOVA||||
1614685|NCT02483611|2963877|Superiority or Other||Mean Difference (Final Values)|21.51|Standard Deviation|3.28||0.0003|2-Sided|95.0|17.5|30.05|||ANOVA||||
1614686|NCT02483611|2963877|Superiority or Other||Mean Difference (Final Values)|33.81|Standard Deviation|10.97||0.0003|2-Sided|95.0|18.5|49.5|||ANOVA||||
1614687|NCT02483611|2963877|Superiority or Other||Mean Difference (Final Values)|27.97|Standard Deviation|6.77||0.0003|2-Sided|95.0|19.5|41.5|||ANOVA||||
1614688|NCT02483611|2963878|Superiority or Other||Mean Difference (Final Values)|14.53|Standard Deviation|1.52||0.0015|2-Sided|95.0|11.0|16.5|||ANOVA||||
1614689|NCT02483611|2963878|Superiority or Other||Mean Difference (Final Values)|20.26|Standard Deviation|7.69||0.0015|2-Sided|95.0|10.5|39.83|||ANOVA||||
1614690|NCT02483611|2963878|Superiority or Other||Mean Difference (Final Values)|20.08|Standard Deviation|6.49||0.0015|2-Sided|95.0|12.0|32.25|||ANOVA||||
1614691|NCT02483611|2963879|Superiority or Other||Median Difference (Final Values)|64.8|||<|0.0001|2-Sided|95.0|40.5|92.9|||Kruskal-Wallis||||
1614692|NCT02483611|2963879|Superiority or Other||Median Difference (Final Values)|86.33|||<|0.0001|2-Sided|95.0|71.78|140.6|||Kruskal-Wallis||||
1614693|NCT02483611|2963879|Superiority or Other||Median Difference (Final Values)|82.68|||<|0.0001|2-Sided|95.0|72.62|99.27|||Kruskal-Wallis||||
1614694|NCT02483611|2963880|Superiority or Other||Mean Difference (Final Values)|147.8|Standard Deviation|29.75||0.9651|2-Sided|95.0|105.0|200.0|||ANOVA|||The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. The pharmacodynamic (latency, clinical duration, recovery rate and total duration) and hemodynamic variables (mean arterial pressure (MAP) and HR) were compared between the groups via analysis of variance (ANOVA) followed by the Tukey post-hoc test. The significance level was set at 5%.|
1614695|NCT02483611|2963880|Superiority or Other||Mean Difference (Final Values)|145.3|Standard Deviation|42.48||0.9651|2-Sided|95.0|78.0|244.0|||ANOVA||||
1614696|NCT02483611|2963880|Superiority or Other||Mean Difference (Final Values)|149.0|Standard Deviation|46.07||0.9651|2-Sided|95.0|88.0|235.0|||ANOVA||||
1614697|NCT02483585|2963883|Superiority||Odds Ratio (OR)|1.33||||0.13|2-Sided|95.0|0.92|1.9|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).|
1614698|NCT02483585|2963884|Superiority||Odds Ratio (OR)|1.22||||0.26|2-Sided|95.0|0.87|1.71|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).|
1614699|NCT02483585|2963885|Superiority||LS Mean Difference|-0.59||||0.002|2-Sided|95.0|-0.96|-0.21|||Generalized Linear Mixed Model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.|
1614700|NCT02483585|2963886|Superiority||Odds Ratio (OR)|1.59||||0.01|2-Sided|95.0|1.12|2.27|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel (CMH) test after the missing data were imputed as nonresponse, stratified by stratification factors (region and prior/current treatment with migraine prophylactic medication).|
1614701|NCT02483585|2963887|Superiority|A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the primary and efficacy secondary endpoints.|LS Mean Difference|-1.04|||<|0.001|2-Sided|95.0|-1.61|-0.47|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and prior/current treatment with migraine prophylactic medication), scheduled visit, and the interaction of treatment group with scheduled visit.|
1614702|NCT02482870|2963922|Superiority or Other|||||||0.75||||||A priori threshold for statistical significance was 0.05.|Chi-squared, Corrected|Chi-square test with Yates' continuity correction: chi-square = 0.101; degrees of freedom = 1|||
1614703|NCT02482870|2963923|Superiority or Other||Mean Difference (Net)|-0.81|||<|0.0001|2-Sided|95.0|-0.95|-0.67||A priori threshold for statistical significance was 0.05.|t-test, 2 sided|t value = -11.224, degrees of freedom = 773.99||"For each patient, the difference between Cormack-Lehane score and Mallampati class was calculated for each laryngoscope. As an example, the first patient had a Mallampati score 3. Macintosh laryngoscope provided a Cormack-Lehane score of 2, therefore the difference is - 1, calculated as 2 - 3. In the same patient, King Vision video laryngoscope provided a Cormack-Lehane score of 1, therefore the difference is - 2, calculated as 1 - 3. T-test was used to compare the differences."|
1614704|NCT02482870|2963924|Superiority or Other||Mean Difference (Net)|0.9|||<|0.0001|2-Sided|95.0|0.5|1.4||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)||||
1614705|NCT02482870|2963925|Superiority or Other||Mean Difference (Final Values)|3.8|||<|0.0001|2-Sided|95.0|3.0|4.6||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)||||
1614706|NCT02482870|2963926|Superiority or Other|||||||0.119||||||A priori threshold for statistical significance was 0.05.|Chi-squared|Chi-square value = 2.424; degrees of freedom = 1||Sample size was calculated according to the first 60 patients. To obtain 90% power with an alpha error of 0.05, a total of 378 patients were required. Considering a possible drop-out rate of 2.5% due to unexpected complications, we aimed for 388 patients.|
1614707|NCT02482428|2963953|Non-Inferiority or Equivalence|p value is provided|Mean Difference (Net)|0.02|Standard Deviation|0.07||0.541|2-Sided|90.0|-0.07|0.19|||posterior mean||||
1614850|NCT02478359|2964209|Superiority||Odds Ratio (OR)|0.92||||0.63|2-Sided|95.0|0.66|1.28|||Regression, Logistic||||
1614708|NCT02482428|2963953|Non-Inferiority or Equivalence|p value is provided|Mean Difference (Net)|0.05|Standard Deviation|0.07||0.862|2-Sided|90.0|-0.03|0.2|||Posterior mean||||
1614709|NCT02482298|2963956|Superiority or Other||Mean Difference (Final Values)|0.0975|Standard Error of the Mean|0.04923|||2-Sided|90.0|0.0155|0.1795|||||||
1614710|NCT02482298|2963956|Superiority or Other||Mean Difference (Final Values)|0.1192|Standard Error of the Mean|0.05059|||2-Sided|90.0|0.035|0.2035|||||||
1614711|NCT02482298|2963958|Superiority or Other||Mean Difference (Final Values)|0.0801|Standard Error of the Mean|0.06192|||2-Sided|90.0|-0.023|0.1832|||||||
1614712|NCT02482298|2963958|Superiority or Other||Mean Difference (Final Values)|0.045|Standard Error of the Mean|0.06367|||2-Sided|90.0|-0.061|0.151|||||||
1614713|NCT02481830|2963988|Superiority||Hazard Ratio (HR)|1.41|||||2-Sided|95.0|1.18|1.69|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin||
1614714|NCT02481830|2963989|Superiority||Hazard Ratio (HR)|0.86||||0.1144|2-Sided|95.0|0.72|1.04|||Log Rank||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Topotecan/Amrubicin||
1614715|NCT02481596|2963990|Superiority|||||||0.034||||||Beta=.101. Threshold p<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.|
1614716|NCT02481596|2963990|Superiority|||||||0.015||||||Beta=.114. Threshold p<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.|
1614717|NCT02481596|2963991|Superiority|||||||0.012||||||Beta=-.115. Threshold p<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.||6 months. Multiply imputed data (m=20) using chained equations.|
1614718|NCT02481596|2963991|Superiority|||||||0.001||||||Beta=-.133. Threshold p<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for helpful involvement subscale of FIAD due to suppression effect.||3 months. Multiply imputed data (m=20) using chained equations.|
1614719|NCT02481596|2963992|Superiority|||||||0.003||||||Beta=.128. Threshold p<.05|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.||6 months. Multiply imputed data (m=20) using chained equations.|
1614720|NCT02481596|2963992|Superiority|||||||0.024||||||Beta=.088. Threshold p<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots); also adjusted for harmful involvement subscale of FIAD due to suppression effect.||3 months. Multiply imputed data (m=20) using chained equations.|
1614721|NCT02481596|2963993|Superiority|||||||0.41||||||Beta=-.037. Threshold p<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.|
1614722|NCT02481596|2963993|Superiority|||||||0.53||||||Beta=-.027. Threshold p<.05|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations|
1614723|NCT02481596|2963994|Superiority|||||||0.092||||||Beta=.092. Threshold p<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.|
1614724|NCT02481596|2963994|Superiority|||||||0.518||||||Beta=.031. Threshold p<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.|
1614725|NCT02481596|2963995|Superiority|||||||0.006||||||Beta=.126. Threshold p<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||6 months. Multiply imputed data (m=20) using chained equations.|
1614726|NCT02481596|2963995|Superiority|||||||0.045||||||Beta=.083. Threshold p<.05.|Regression, Linear|Adjusted for baseline values with cubic splines (3 knots).||3 months. Multiply imputed data (m=20) using chained equations.|
1614727|NCT02481375|2963998|Other||Marginal means|0.0|||<|0.05|2-Sided|95.0|||||Regression, Linear|||Marginal means (95% CI) of ferritin concentrations at 12-weeks using a generalized mixed-effects model with adjustments for baseline values and village clusters|
1614728|NCT02481258|2964005|Equivalence|Power calculations were based on a two-sample t-test. A priori calculations to detect an effect size of 0.57 units indicated that that 50 patients per arm were needed to have 80% power. The actual effect size observed in the present study was 0.86.||||||0.05|||||||ANCOVA|||The statistical analysis was done using an ANCOVA analysis adjusting for the baseline aortic valve calcium levels.|
1614729|NCT02480764|2964033|Other||Odds Ratio (OR)|1.769|Standard Error of the Mean|0.4136||0.015|2-Sided|95.0|1.118|2.797||Clinic SBP<130 mm Hg and DBP<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic||||
1614730|NCT02480764|2964033|Other||Odds Ratio (OR)|1.424|Standard Error of the Mean|0.3407||0.14|2-Sided|95.0|0.891|2.276||Clinic SBP<130 mm Hg and DBP<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic||||
1614731|NCT02480764|2964033|Other||Odds Ratio (OR)|2.017|Standard Error of the Mean|0.4816||0.003|2-Sided|95.0|1.263|3.22||Clinic DBP <80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic||||
1614732|NCT02480764|2964033|Other||Odds Ratio (OR)|1.427|Standard Error of the Mean|0.3414||0.137|2-Sided|95.0|0.893|2.28||Clinic DBP<80 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic||||
1614733|NCT02480764|2964033|Other||Odds Ratio (OR)|1.914|Standard Error of the Mean|0.4229||0.003|2-Sided|95.0|1.241|2.951||Clinic SBP<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic||||
1614734|NCT02480764|2964033|Other||Odds Ratio (OR)|1.487|Standard Error of the Mean|0.3333||0.077|2-Sided|95.0|0.958|2.307||Clinic SBP<130 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic||||
1614758|NCT02480439|2964057|Superiority or Other||Point Estimate|1.0149|||||2-Sided|90.0|0.9685|1.0636|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.||
1614735|NCT02480764|2964034|Other||Odds Ratio (OR)|1.172|Standard Error of the Mean|0.2517||0.46|2-Sided|95.0|0.769|1.785||Clinic SBP<140 mm Hg and DBP<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic||||
1614736|NCT02480764|2964034|Other||Odds Ratio (OR)|1.042|Standard Error of the Mean|0.2244||0.847|2-Sided|95.0|0.684|1.59||Clinic SBP<140 mm Hg and DBP<90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic||||
1614737|NCT02480764|2964034|Other||Odds Ratio (OR)|1.045|Standard Error of the Mean|0.2788||0.868|2-Sided|95.0|0.62|1.763||Clinic DBP <90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic||||
1614738|NCT02480764|2964034|Other||Odds Ratio (OR)|1.051|Standard Error of the Mean|0.2837||0.852|2-Sided|95.0|0.62|1.784||Clinic DBP <90 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic||||
1614739|NCT02480764|2964034|Other||Odds Ratio (OR)|0.937|Standard Error of the Mean|0.2078||0.768|2-Sided|95.0|0.606|1.447||Clinic SBP <140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic||||
1614740|NCT02480764|2964034|Other||Odds Ratio (OR)|0.831|Standard Error of the Mean|0.1846||0.404|2-Sided|95.0|0.537|1.284||Clinic SBP <140 mm Hg: P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic||||
1614741|NCT02480764|2964035|Other||Odds Ratio (OR)|1.103|Standard Error of the Mean|0.235||0.647|2-Sided|95.0|0.726|1.674||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic||||
1614742|NCT02480764|2964035|Other||Odds Ratio (OR)|0.901|Standard Error of the Mean|0.1916||0.624|2-Sided|95.0|0.594|1.367||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic||||
1614743|NCT02480764|2964036|Other||Odds Ratio (OR)|1.074|Standard Error of the Mean|0.2897||0.79|2-Sided|95.0|0.633|1.823||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic||||
1614744|NCT02480764|2964036|Other||Odds Ratio (OR)|1.033|Standard Error of the Mean|0.2805||0.904|2-Sided|95.0|0.607|1.759||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough DBP as a continuous covariate.|Regression, Logistic||||
1614745|NCT02480764|2964037|Other||Odds Ratio (OR)|0.979|Standard Error of the Mean|0.2136||0.921|2-Sided|95.0|0.638|1.501||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic||||
1614746|NCT02480764|2964037|Other||Odds Ratio (OR)|0.877|Standard Error of the Mean|0.192||0.548|2-Sided|95.0|0.571|1.347||P-value was calculated using logistic regression model with treatment group as a fixed effect and baseline trough SBP as a continuous covariate.|Regression, Logistic||||
1614747|NCT02480764|2964038|Other||Least Square Mean Difference|-2.822|Standard Error of the Mean|0.9354||0.003|2-Sided|95.0|-4.659|-0.985||Change at 8 Week: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.|ANCOVA||||
1614748|NCT02480764|2964038|Other||Least Square Mean Difference|-1.459|Standard Error of the Mean|0.9455||0.123|2-Sided|95.0|-3.316|0.397||Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic DBP as a continuous covariate.|ANCOVA||||
1614749|NCT02480764|2964039|Non-Inferiority|A test for noninferiority was done using a margin of 1.5 mm Hg. A test for significant difference was performed at 5% level.|Least Square Mean Difference|-3.685|Standard Error of the Mean|1.4344||0.01|2-Sided|95.0|-6.502|-0.868||Change at Week 8: P-value was calculated using ANCOVA model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate.|ANCOVA||||
1614750|NCT02480764|2964039|Non-Inferiority|A test for noninferiority was done using a margin of 1.5 mm Hg. A test for significant difference was performed at 5% level.|Least Square Mean Difference|-1.932|Standard Error of the Mean|1.4512||0.184|2-Sided|95.0|-4.782|0.918||Change at Week 8: P-value was calculated using analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and baseline trough sitting clinic SBP as a continuous covariate.|ANCOVA||||
1614751|NCT02480621|2964048|Superiority||Mean Difference (Net)|1.74|||<|0.1|2-Sided||||||t-test, 2 sided||||
1614752|NCT02480582|2964049|Superiority or Other||||||<|0.05|||||||ANOVA|Null hypothesis is that there was no difference in energy intake between almonds, cheese savouries and no food.||"Energy intake measured by ad-libitum test meals (breakfast, lunch, dinner) during each intervention condition.~Null hypothesis is that there was no difference in total energy intake between almonds, cheese savouries and no food."|
1614753|NCT02480582|2964050|Superiority or Other||||||<|0.001||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in hunger AUC between almonds, cheese savouries and no food.|||
1614754|NCT02480582|2964051|Superiority or Other||||||<|0.05||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in wanting for high fat foods between almonds, cheese savouries and no food.|||
1614755|NCT02480582|2964052|Superiority or Other||||||<|0.01||||||Where significant effects were obtained post hoc analyses, with a Bonferroni correction for multiple comparisons were conducted.|ANOVA|Null hypothesis is that there was no difference in energy intake between almonds, cheese savouries and no food.|||
1614756|NCT02480439|2964056|Superiority or Other||Point Estimate|1.0134|||||2-Sided|90.0|0.9676|1.0612|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.||
1614757|NCT02480439|2964056|Superiority or Other||Point Estimate|0.9992|||||2-Sided|90.0|0.9541|1.0464|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.||
1614759|NCT02480439|2964057|Superiority or Other||Point Estimate|0.9998|||||2-Sided|90.0|0.954|1.0477|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.||
1614760|NCT02480439|2964058|Superiority or Other||Point Estimate|0.9223|||||2-Sided|90.0|0.8352|1.0185|||||Relative Bioavailability B/C. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.||
1614761|NCT02480439|2964058|Superiority or Other||Point Estimate|0.966|||||2-Sided|90.0|0.8747|1.0668|||||Relative Bioavailability A/B. The point estimates and 90% CIs were obtained from the exponentiated results of the analysis of the natural logarithm-transformed data.||
1614762|NCT02480153|2964116|Non-Inferiority or Equivalence|Confidence interval (CIs) calculated by the score statistic method were used for the inference of the equivalence for ACR20 at Week 12. Therapeutic equivalence could be established if 2-sided 90% CI fell within (-12%, 15%). Non-responder imputation was applied. Comparisons between treatments were computed as PF-06410293 versus Adalimumab-EU.|Week 12 ACR20 response rate difference|-2.98|||||2-Sided|90.0|-9.25|3.28|||||||
1614763|NCT02480153|2964116|Non-Inferiority or Equivalence|Confidence interval (CIs) calculated by the score statistic method were used for the inference of the equivalence for ACR20 at Week 12. Therapeutic equivalence could be established if the 2-sided 95% CI fell within (-14%, 14%). Non-responder imputation was applied. Comparisons between treatments were computed as PF-06410293 versus Adalimumab-EU.|Week 12 ACR20 response rate difference|-2.98|||||2-Sided|95.0|-10.38|4.44|||||||
1614764|NCT02479412|2964146|Superiority or Other||Ratio Estimate (%)|964.62|||<|0.0001|2-Sided|90.0|816.13|1140.13|||ANOVA|||AZD7594 800 μg versus AZD7594 58 μg|
1614765|NCT02479412|2964146|Superiority or Other||Ratio Estimate (%)|337.82|||<|0.0001|2-Sided|90.0|290.8|392.43|||ANOVA|||AZD7594 250 μg versus AZD7594 58 μg|
1614766|NCT02479412|2964147|Superiority or Other||Ratio Estimate (%)|676.13|||<|0.0001|2-Sided|90.0|580.91|786.95|||ANOVA|||AZD7594 800 μg versus AZD7594 58 μg|
1614767|NCT02479412|2964147|Superiority or Other||Ratio Estimate (%)|272.2|||<|0.0001|2-Sided|90.0|237.43|312.05|||ANOVA|||AZD7594 250 μg versus AZD7594 58 μg|
1614768|NCT02479412|2964151|Superiority or Other||Mean Difference (Final Values)|0.9415|Standard Error of the Mean|0.2987||0.0022|2-Sided|95.0|0.3483|1.535|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO|
1614769|NCT02479412|2964151|Superiority or Other||Mean Difference (Final Values)|0.4281|Standard Error of the Mean|0.2965||0.1521|2-Sided|95.0|-0.1607|1.017|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO|
1614770|NCT02479412|2964151|Superiority or Other||Mean Difference (Final Values)|0.673|Standard Error of the Mean|0.2946||0.0247|2-Sided|95.0|0.08779|1.258|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO|
1614771|NCT02479412|2964152|Superiority or Other||Mean Difference (Final Values)|-0.2027|Standard Error of the Mean|0.05044||0.0001|2-Sided|95.0|-0.3028|-0.1025|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO|
1614772|NCT02479412|2964152|Superiority or Other||Mean Difference (Final Values)|-0.08205|Standard Error of the Mean|0.05015||0.1052|2-Sided|95.0|-0.1817|0.01756|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO|
1614773|NCT02479412|2964152|Superiority or Other||Mean Difference (Final Values)|-0.1067|Standard Error of the Mean|0.04982||0.0349|2-Sided|95.0|-0.2057|-0.007755|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO|
1614774|NCT02479412|2964153|Superiority or Other||Mean Difference (Final Values)|-0.7661|Standard Error of the Mean|0.1636|<|0.0001|2-Sided|95.0|-1.091|-0.4411|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO|
1614775|NCT02479412|2964153|Superiority or Other||Mean Difference (Final Values)|-0.1794|Standard Error of the Mean|0.1628|<|0.2732|2-Sided|95.0|-0.5027|0.1438|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO|
1614776|NCT02479412|2964153|Superiority or Other||Mean Difference (Final Values)|-0.4185|Standard Error of the Mean|0.1626|<|0.0116|2-Sided|95.0|-0.7414|-0.09563|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO|
1614777|NCT02479412|2964154|Superiority or Other||Mean Difference (Final Values)|-0.2532|Standard Error of the Mean|0.09176||0.007|2-Sided|95.0|-0.4354|-0.07092|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO|
1614778|NCT02479412|2964154|Superiority or Other||Mean Difference (Final Values)|-0.09079|Standard Error of the Mean|0.09204||0.3265|2-Sided|95.0|-0.2736|0.09201|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO|
1614779|NCT02479412|2964154|Superiority or Other||Mean Difference (Final Values)|-0.1651|Standard Error of the Mean|0.09139||0.0741|2-Sided|95.0|-0.3466|0.01638|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO|
1614780|NCT02479412|2964155|Superiority or Other||Mean Difference (Final Values)|-0.4301|Standard Error of the Mean|0.1055|<|0.0001|2-Sided|95.0|-0.6397|-0.2205|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO|
1614781|NCT02479412|2964155|Superiority or Other||Mean Difference (Final Values)|-0.1824|Standard Error of the Mean|0.1059|<|0.0883|2-Sided|95.0|-0.3927|0.02789|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO|
1614782|NCT02479412|2964155|Superiority or Other||Mean Difference (Final Values)|-0.3071|Standard Error of the Mean|0.1051|<|0.0044|2-Sided|95.0|-0.5159|-0.09836|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO|
1614783|NCT02479412|2964156|Superiority or Other||Mean Difference (Final Values)|-0.8026|Standard Error of the Mean|0.1914|<|0.0001|2-Sided|95.0|-1.183|-0.4224|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO|
1614784|NCT02479412|2964156|Superiority or Other||Mean Difference (Final Values)|-0.4852|Standard Error of the Mean|0.1903|<|0.0124|2-Sided|95.0|-0.8631|-0.1073|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO|
1614785|NCT02479412|2964156|Superiority or Other||Mean Difference (Final Values)|-0.3435|Standard Error of the Mean|0.189|<|0.0723|2-Sided|95.0|-0.7189|0.03179|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO|
1614786|NCT02479412|2964157|Superiority or Other||Mean Difference (Final Values)|19.91|Standard Error of the Mean|5.459||0.0004|2-Sided|95.0|9.068|30.75|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO|
1614787|NCT02479412|2964157|Superiority or Other||Mean Difference (Final Values)|14.3|Standard Error of the Mean|5.419||0.0098|2-Sided|95.0|3.534|25.06|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO|
1614788|NCT02479412|2964157|Superiority or Other||Mean Difference (Final Values)|15.73|Standard Error of the Mean|5.384||0.0044|2-Sided|95.0|5.039|26.43|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO|
1614789|NCT02479412|2964158|Superiority or Other||Mean Difference (Final Values)|12.52|Standard Error of the Mean|5.926||0.0374|2-Sided|95.0|0.7481|24.29|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO|
1614790|NCT02479412|2964158|Superiority or Other||Mean Difference (Final Values)|5.253|Standard Error of the Mean|5.881||0.3741|2-Sided|95.0|-6.427|16.93|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO|
1614791|NCT02479412|2964158|Superiority or Other||Mean Difference (Final Values)|10.34|Standard Error of the Mean|5.877||0.0819|2-Sided|95.0|-1.335|22.01|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO|
1614792|NCT02479412|2964159|Superiority or Other||Mean Difference (Final Values)|0.06831|Standard Error of the Mean|0.05774||0.2398|2-Sided|95.0|-0.04637|0.183|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO|
1614793|NCT02479412|2964159|Superiority or Other||Mean Difference (Final Values)|-0.000314|Standard Error of the Mean|0.05755||0.9957|2-Sided|95.0|-0.1146|0.114|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO|
1614794|NCT02479412|2964159|Superiority or Other||Mean Difference (Final Values)|-0.02262|Standard Error of the Mean|0.05743||0.6945|2-Sided|95.0|-0.1367|0.09144|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO|
1614795|NCT02479412|2964160|Superiority or Other||Mean Difference (Final Values)|0.06169|Standard Error of the Mean|0.05371||0.2538|2-Sided|95.0|-0.04501|0.1684|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO|
1614796|NCT02479412|2964160|Superiority or Other||Mean Difference (Final Values)|0.02821|Standard Error of the Mean|0.05336||0.5983|2-Sided|95.0|-0.07778|0.1342|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO|
1614797|NCT02479412|2964160|Superiority or Other||Mean Difference (Final Values)|-0.03467|Standard Error of the Mean|0.05377||0.5207|2-Sided|95.0|-0.1415|0.07213|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO|
1614798|NCT02479412|2964161|Superiority or Other||Mean Difference (Final Values)|0.1561|Standard Error of the Mean|0.05874||0.0093|2-Sided|95.0|0.03943|0.2728|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO|
1614799|NCT02479412|2964161|Superiority or Other||Mean Difference (Final Values)|0.01744|Standard Error of the Mean|0.05869||0.767|2-Sided|95.0|-0.09912|0.134|||Mixed Models Analysis|||AZD7594 250 μg vs. PBO|
1614800|NCT02479412|2964161|Superiority or Other||Mean Difference (Final Values)|0.03051|Standard Error of the Mean|0.05856||0.6036|2-Sided|95.0|-0.08579|0.1468|||Mixed Models Analysis|||AZD7594 58 μg vs. PBO|
1614801|NCT02479412|2964162|Superiority or Other||Mean Difference (Final Values)|-19.9|Standard Error of the Mean|5.137||0.0002|2-Sided|95.0|-30.1|-9.689|||Mixed Models Analysis|||AZD7594 800 µg vs. PBO|
1614802|NCT02479412|2964162|Superiority or Other||Mean Difference (Final Values)|-14.26|Standard Error of the Mean|5.088||0.0062|2-Sided|95.0|-24.37|-4.149|||Mixed Models Analysis|||AZD7594 250 µg vs. PBO|
1614803|NCT02479412|2964162|Superiority or Other||Mean Difference (Final Values)|-13.85|Standard Error of the Mean|5.139||0.0084|2-Sided|95.0|-24.06|-3.642|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO|
1614804|NCT02479412|2964163|Superiority or Other||Mean Difference (Final Values)|-14.75|Standard Error of the Mean|3.236|<|0.0001|2-Sided|95.0|-21.18|-8.319|||Mixed Models Analysis|||AZD7594 800 µg vs. PBO|
1614805|NCT02479412|2964163|Superiority or Other||Mean Difference (Final Values)|-10.41|Standard Error of the Mean|3.19|<|0.0016|2-Sided|95.0|-16.75|-4.075|||Mixed Models Analysis|||AZD7594 250 µg vs. PBO|
1614806|NCT02479412|2964163|Superiority or Other||Mean Difference (Final Values)|-4.857|Standard Error of the Mean|3.214|<|0.1342|2-Sided|95.0|-11.24|1.528|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO|
1614807|NCT02479412|2964164|Superiority or Other||Mean Difference (Final Values)|0.1478|Standard Error of the Mean|0.05679||0.0108|2-Sided|95.0|0.03494|0.2606|||Mixed Models Analysis|||AZD7594 800 μg vs. PBO|
1614808|NCT02479412|2964164|Superiority or Other||Mean Difference (Final Values)|0.07604|Standard Error of the Mean|0.05663||0.1827|2-Sided|95.0|-0.03645|0.1885|||Mixed Models Analysis|||AZD7594 250 µg vs.PBO|
1614809|NCT02479412|2964164|Superiority or Other||Mean Difference (Final Values)|0.02691|Standard Error of the Mean|0.05697||0.6379|2-Sided|95.0|-0.08626|0.1401|||Mixed Models Analysis|||AZD7594 58 µg vs. PBO|
1614810|NCT02478632|2964174|Other||Mean Difference (Final Values)|0.04|||||2-Sided|95.0|-0.26|0.34|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent PI.||
1614811|NCT02478632|2964174|Other||Mean Difference (Final Values)|0.12|||||2-Sided|95.0|-0.02|0.26|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent NNRTI.||
1614812|NCT02478632|2964174|Other||Mean Difference (Final Values)|0.38|||||2-Sided|95.0|0.03|0.74|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine Z-scores by baseline third agent INSTI.||
1614813|NCT02478632|2964174|Other||Mean Difference (Final Values)|0.01|||||2-Sided|95.0|-0.3|0.33|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent PI.||
1614814|NCT02478632|2964174|Other||Mean Difference (Final Values)|0.11|||||2-Sided|95.0|-0.03|0.25|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent NNRTI.||
1614815|NCT02478632|2964174|Other||Mean Difference (Final Values)|0.36|||||2-Sided|95.0|0.01|0.71|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in lumbar spine T-scores by baseline third agent INSTI.||
1614816|NCT02478632|2964174|Other||Mean Difference (Final Values)|0.04|||||2-Sided|95.0|-0.14|0.21|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent PI.||
1614817|NCT02478632|2964174|Other||Mean Difference (Final Values)|0.1|||||2-Sided|95.0|0.02|0.18|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent NNRTI.||
1614818|NCT02478632|2964174|Other||Mean Difference (Final Values)|0.06|||||2-Sided|95.0|-0.25|0.37|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip Z-scores by baseline third agent INSTI.||
1614819|NCT02478632|2964174|Other||Mean Difference (Final Values)|0.07|||||2-Sided|95.0|-0.09|0.24|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent PI.||
1614820|NCT02478632|2964174|Other||Mean Difference (Final Values)|0.11|||||2-Sided|95.0|0.03|0.19|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent NNRTI.||
1614821|NCT02478632|2964174|Other||Mean Difference (Final Values)|0.02|||||2-Sided|95.0|-0.26|0.3|||||The analysis estimated comparison of change from baseline to Week 48 between the DTG+RPV and CAR groups in total hip T-scores by baseline third agent INSTI.||
1614822|NCT02478632|2964175|Other||Mean Difference (Final Values)|0.38|||||2-Sided|95.0|-3.0|3.77|||||this analysis refers to PI and lumbar spine||
1614823|NCT02478632|2964175|Other||Mean Difference (Final Values)|1.25|||||2-Sided|95.0|-0.26|2.76|||||this analysis refers to NNRTI and lumbar spine||
1614824|NCT02478632|2964175|Other||Mean Difference (Final Values)|3.85|||||2-Sided|95.0|0.67|7.03|||||this analysis refers to INSTI and lumbar spine.||
1614825|NCT02478632|2964175|Other||Mean Difference (Final Values)|1.0|||||2-Sided|95.0|-1.39|3.38|||||this analysis refers to PI and total hip||
1614826|NCT02478632|2964175|Other||Mean Difference (Final Values)|1.6|||||2-Sided|95.0|0.39|2.81|||||The analysis refers to NNRTI and total hip.||
1614827|NCT02478632|2964175|Other||Mean Difference (Final Values)|0.65|||||2-Sided|95.0|-3.51|4.81|||||The analysis refers to INSTI and total hip.||
1614828|NCT02478632|2964178|Superiority||Mean Difference (Final Values)|0.15||||0.013|2-Sided|95.0|0.03|0.27||p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine Z-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR in lumbar spine Z-score.||
1614829|NCT02478632|2964178|Superiority||Mean Difference (Final Values)|0.12||||0.049|2-Sided|95.0|0.0|0.23||p value for the difference in adjusted change from Baseline at Week 48 in lumbar spine T-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR for lumbar spine T-score.||
1614830|NCT02478632|2964178|Superiority||Mean Difference (Final Values)|0.08||||0.026|2-Sided|95.0|0.01|0.15||p value for the difference in adjusted change from Baseline at Week 48 in total hip Z-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated difference between DTG+RPV and CAR in total hip Z-score.||
1614831|NCT02478632|2964178|Superiority||Mean Difference (Final Values)|0.09||||0.016|2-Sided|95.0|0.02|0.16||p value for the difference in adjusted change from Baseline at Week 48 in total hip T-scores between the DTG+RPV and CAR groups|ANCOVA||The analysis estimated the difference between DTG+RPV and CAR in total hip T-scores||
1614832|NCT02478632|2964181|Superiority||Mean Difference (Final Values)|1.32||||0.039|2-Sided|95.0|0.07|2.57|||ANCOVA||||
1614833|NCT02478632|2964182|Superiority||Mean Difference (Final Values)|1.29||||0.014|2-Sided|95.0|0.27|2.31|||ANCOVA||||
1614834|NCT02478398|2964185|Other||Difference in % estimates|0.0|||=|0|2-Sided|95.0|-0.92|0.92|||Miettinen & Nurminen||||
1614835|NCT02478398|2964186|Other||Difference in % estimates|0.39|||=|0|2-Sided|95.0|-0.57|1.53|||Miettinen & Nurminen||||
1614836|NCT02478398|2964187|Other||Difference in % estimates|37.61|||<|0.001|2-Sided|95.0|31.82|43.12|||Miettinen & Nurminen||||
1614837|NCT02478398|2964188|Superiority||Mean Difference (Final Values)|-1.84|||<|0.001|2-Sided|95.0|-2.6|-1.08|||Zero-Inflated Log-Normal Model|Model included fixed effects of treatment, baseline asthma, age group, pollen season, and pollen region nested within pollen season|||
1614838|NCT02478398|2964189|Superiority||Mean Difference (Final Values)|-1.4|||<|0.001|2-Sided|95.0|-1.81|-0.99|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season|||
1614839|NCT02478398|2964190|Superiority||Difference in LS Mean|-1.86|||<|0.001|2-Sided|95.0|-2.46|-1.27|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season|||
1614840|NCT02478398|2964191|Superiority||Mean Difference (Final Values)|-2.73|||<|0.001|2-Sided|95.0|-3.45|-2.0|||ANOVA|Model included fixed effects of treatment, baseline asthma status, age group, pollen season, and pollen region nested within pollen season|||
1614841|NCT02478372|2964200|Superiority or Other|||||||0.332||||||Significance was set at <0.01|Chi-squared||||
1614842|NCT02478359|2964201|Superiority|||||||0.83||||||Adjusted P value|Regression, Linear|||Covariated included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site|
1614843|NCT02478359|2964202|Superiority|||||||0.11||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site|
1614844|NCT02478359|2964203|Superiority|||||||0.34||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site|
1614845|NCT02478359|2964204|Superiority|||||||0.13||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site|
1614846|NCT02478359|2964205|Superiority|||||||0.67||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site|
1614847|NCT02478359|2964206|Superiority|||||||0.07||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site|
1614848|NCT02478359|2964207|Superiority|||||||0.06||||||Adjusted P value|Regression, Linear|||Covariates included in the as-treated adjusted linear regression analyses were age, FEV1%predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level, and study site|
1614851|NCT02478359|2964210|Superiority||Odds Ratio (OR)|1.07||||0.6|2-Sided|95.0|0.84|1.36|||Regression, Logistic||||
1614852|NCT02478359|2964211|Superiority||Odds Ratio (OR)|0.84||||0.21|2-Sided|95.0|0.65|1.1|||Regression, Logistic||||
1614853|NCT02478359|2964212|Superiority||Odds Ratio (OR)|0.62||||0.11|2-Sided|95.0|0.35|1.11|||Regression, Logistic||||
1614854|NCT02478359|2964213|Superiority||Odds Ratio (OR)|1.05||||0.69|2-Sided|95.0|0.82|1.35|||Regression, Logistic||||
1614855|NCT02478359|2964214|Superiority|||||||0.57|||||||t-test, 2 sided||||
1614856|NCT02478359|2964215|Superiority|||||||0.86||||||Adjusted P values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|
1614857|NCT02478359|2964216|Superiority|||||||0.16||||||Adjusted P values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|
1614858|NCT02478359|2964217|Superiority|||||||0.82||||||Adjusted P Values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|
1614859|NCT02478359|2964218|Superiority|||||||0.09||||||Adjusted P Values|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|
1614860|NCT02478359|2964219|Superiority|||||||0.35|||||||Regression, Linear|Adjusted P Values||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|
1614861|NCT02478359|2964220|Superiority|||||||0.7||||||Adjusted P value|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|
1614862|NCT02478359|2964221|Superiority|||||||0.87||||||Adjusted P value|Regression, Linear|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|
1614863|NCT02478359|2964222|Superiority|||||||0.33|||||||Regression, Linear||||
1614864|NCT02478359|2964223|Superiority|||||||0.47|||||||Regression, Linear||||
1614865|NCT02478359|2964224|Superiority|||||||0.32|||||||Regression, Linear||||
1614866|NCT02478359|2964225|Superiority|||||||0.6|||||||Regression, Linear||||
1614867|NCT02478359|2964226|Superiority|||||||0.34||||||adjusted p values|Regression, Logistic|||Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|
1614868|NCT02478359|2964227|Superiority|||||||0.55|||||||Regression, Linear||||
1614869|NCT02478359|2964228|Superiority|||||||0.41|||||||t-test, 2 sided||||
1614870|NCT02478359|2964229|Superiority||Odds Ratio (OR)|1.1||||0.26|2-Sided|95.0|0.93|1.31|||Regression, Logistic||||
1614871|NCT02478359|2964230|Superiority||Odds Ratio (OR)|1.13||||0.21|2-Sided|95.0|0.93|1.37|||Regression, Logistic||||
1614872|NCT02478359|2964231|Superiority||Odds Ratio (OR)|1.03||||0.73|2-Sided|95.0|0.88|1.2|||Regression, Logistic||||
1614873|NCT02478359|2964232|Superiority||Odds Ratio (OR)|1.05||||0.53|2-Sided|95.0|0.89|1.24|||Regression, Logistic||||
1614874|NCT02478359|2964233|Superiority||Odds Ratio (OR)|1.02||||0.88|2-Sided|95.0|0.77|1.36|||Regression, Logistic||||
1614875|NCT02478359|2964234|Superiority||Odds Ratio (OR)|1.09||||0.33|2-Sided|95.0|0.92|1.28|||Regression, Logistic||||
1614876|NCT02477618|2964241|Superiority||LS Mean Difference|-0.2||||0.567|2-Sided|95.0|-0.9|0.5|||ANCOVA||||
1614877|NCT02477618|2964242|Superiority||Hazard Ratio (HR)|1.086||||0.817|2-Sided|95.0|0.539|2.189|||Regression, Cox||||
1614878|NCT02477618|2964243|Superiority||Hazard Ratio (HR)|0.583||||0.339|2-Sided|95.0|0.193|1.763|||Regression, Cox||||
1614879|NCT02477618|2964245|Superiority||Hazard Ratio (HR)|0.683||||0.328|2-Sided|95.0|0.318|1.466|||Regression, Cox||||
1614880|NCT02477618|2964246|Superiority||Odds Ratio (OR)|0.623||||0.199|2-Sided|95.0|0.303|1.282|||Regression, Logistic||||
1614881|NCT02477618|2964247|Superiority||Hazard Ratio (HR)|0.747||||0.636|2-Sided|95.0|0.222|2.507|||Regression, Cox||||
1614882|NCT02477618|2964248|Superiority||Odds Ratio (OR)|1.056||||0.878|2-Sided|95.0|0.527|2.118|||Regression, Logistic||||
1614883|NCT02477332|2964277|Superiority||Estimated target dose|32.5|||<|0.05|2-Sided|60.0|27.5|42.5|||Regression, Logistic|Target dose was based on this estimated dose response. The 60% CI included the 20 - 80th percentile of target dose estimated in the bootstrap samples.|Min dose with effect size >15%||
1614984|NCT02476890|2964317|Other||Mean Difference (Final Values)|0.56||||0.1771|2-Sided|95.0|-0.3|1.4|||Mixed Models Analysis|||C2 Response/Healthy|
1614985|NCT02476890|2964318|Other||Mean Difference (Final Values)|0.25||||0.4287|2-Sided|95.0|-0.4|0.9|||Mixed Models Analysis|||C5 Response/Chronic Cough|
1615542|NCT02451839|2966006|Superiority||||||<|0.001|||||||paired t-test||||
1614884|NCT02477020|2964287|Superiority or Other||Least mean square difference|-0.54|Standard Error of the Mean|2.255||0.812|2-Sided|95.0|-5.0|3.92||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline UPSA-B composite score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline UPSA-B composite score-by-week interaction.|Change at Week 6|
1614885|NCT02477020|2964287|Superiority or Other||Least square mean difference|0.06|Standard Error of the Mean|1.855||0.973|2-Sided|95.0|-3.61|3.73||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline UPSA-B composite score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline UPSA-B composite score-by-week interaction.|Change at Week 3|
1614886|NCT02477020|2964288|Superiority or Other||Least square mean difference|2.62|Standard Error of the Mean|2.313||0.26|2-Sided|95.0|-1.96|7.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline PSP score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PSP score-by-week interaction.|Change at Week 6|
1614887|NCT02477020|2964288|Superiority or Other||Least square mean difference|2.69|Standard Error of the Mean|1.769||0.131|2-Sided|95.0|-0.81|6.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline PSP score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PSP score-by-week interaction.|Change at Week 3|
1614888|NCT02477020|2964289|Superiority or Other||Least square mean difference|-2.87|Standard Error of the Mean|2.05||0.163|2-Sided|95.0|-6.93|1.18||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline BNSS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction.|Change at Week 6|
1614889|NCT02477020|2964289|Superiority or Other||Least mean square difference|-0.38|Standard Error of the Mean|1.664||0.82|2-Sided|95.0|-3.67|2.91||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline BNSS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BNSS total score-by-week interaction.|Change at Week 3|
1614890|NCT02477020|2964290|Superiority or Other||Least square mean difference|2.2|Standard Error of the Mean|1.767||0.216|2-Sided|95.0|-1.3|5.69||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|Least square mean difference||TAK-063 – Placebo. Baseline BACS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction|Change at Week 6|
1614891|NCT02477020|2964290|Superiority or Other||Least square mean difference|1.8|Standard Error of the Mean|1.547||0.246|2-Sided|95.0|-1.26|4.86||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline BACS total score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline BACS total score-by-week interaction.|Change at Week 3|
1614892|NCT02477020|2964291|Superiority or Other||Odds Ratio (OR)|3.44||||0.003|2-Sided|95.0|1.523|7.77||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 6|
1614893|NCT02477020|2964291|Superiority or Other||Odds Ratio (OR)|1.739||||0.164|2-Sided|95.0|0.798|3.789||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 5|
1614894|NCT02477020|2964291|Superiority or Other||Odds Ratio (OR)|1.737||||0.158|2-Sided|95.0|0.807|3.735||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 4|
1614895|NCT02477020|2964291|Superiority or Other||Odds Ratio (OR)|2.69||||0.015|2-Sided|95.0|1.208|5.99||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 3|
1614896|NCT02477020|2964291|Superiority or Other||Odds Ratio (OR)|2.331||||0.036|2-Sided|95.0|1.055|5.153||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 2|
1614897|NCT02477020|2964291|Superiority or Other||Odds Ratio (OR)|2.726||||0.077|2-Sided|95.0|0.899|8.267||No multiplicity adjustment.|Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline CGI-S score.|Week 1|
1614898|NCT02477020|2964292|Superiority or Other||Least square mean difference|-0.66|Standard Error of the Mean|0.244||0.007|2-Sided|95.0|-1.15|-0.18||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 6|
1614899|NCT02477020|2964292|Superiority or Other||Least mean square difference|-0.56|Standard Error of the Mean|0.238||0.02|2-Sided|95.0|-1.03|-0.09||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 5|
1614900|NCT02477020|2964292|Superiority or Other||Least square mean difference|-0.55|Standard Error of the Mean|0.22||0.013|2-Sided|95.0|-0.99|-0.12||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 4|
1614986|NCT02476890|2964318|Other||Mean Difference (Final Values)|0.32||||0.2823|2-Sided|95.0|-0.3|0.9|||Mixed Models Analysis|||C2 Response/Chronic Cough|
1614901|NCT02477020|2964292|Superiority or Other||Least square mean difference|-0.57|Standard Error of the Mean|0.203||0.006|2-Sided|95.0|-0.97|-0.17||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 3|
1614902|NCT02477020|2964292|Superiority or Other||Least mean square difference|-0.37|Standard Error of the Mean|0.173||0.034|2-Sided|95.0|-0.72|-0.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 2|
1614903|NCT02477020|2964292|Superiority or Other||Least square mean difference|-0.04|Standard Error of the Mean|0.128||0.746|2-Sided|95.0|-0.29|0.21||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Week 1|
1614904|NCT02477020|2964293|Superiority or Other||Least square mean difference|-0.43|Standard Error of the Mean|0.202||0.035||95.0|-0.83|-0.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 6|
1614905|NCT02477020|2964293|Superiority or Other||Least square mean difference|-0.47|Standard Error of the Mean|0.191||0.016|2-Sided|95.0|-0.85|-0.09||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 5|
1614906|NCT02477020|2964293|Superiority or Other||Least square mean difference|-0.36|Standard Error of the Mean|0.18||0.049|2-Sided|95.0|-0.72|0.0||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 4|
1614907|NCT02477020|2964293|Superiority or Other||Least square mean difference|-0.44|Standard Error of the Mean|0.166||0.009|2-Sided|95.0|-0.77|-0.11||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 3|
1614908|NCT02477020|2964293|Superiority or Other||Least square mean difference|-0.21|Standard Error of the Mean|0.136||0.116|2-Sided|95.0|-0.48|0.05||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 2|
1614909|NCT02477020|2964293|Superiority or Other||Least square mean difference|-0.05|Standard Error of the Mean|0.095||0.619|2-Sided|95.0|-0.23|0.14||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline CGI-S score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline CGI-S score-by-week interaction.|Change at Week 1|
1614910|NCT02477020|2964294|Superiority or Other||Odds Ratio (OR)|1.567||||0.253||95.0|0.725|3.388|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 6|
1614911|NCT02477020|2964294|Superiority or Other||Odds Ratio (OR)|1.542||||0.263|2-Sided|95.0|0.722|3.292|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 5|
1614912|NCT02477020|2964294|Superiority or Other||Odds Ratio (OR)|1.222||||0.596|2-Sided|95.0|0.583|2.561|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 4|
1614913|NCT02477020|2964294|Superiority or Other||Odds Ratio (OR)|1.818||||0.108|2-Sided|95.0|0.877|3.771|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 3|
1614914|NCT02477020|2964294|Superiority or Other||Odds Ratio (OR)|2.782||||0.009|2-Sided|95.0|1.287|6.014|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 2|
1614915|NCT02477020|2964294|Superiority or Other||Odds Ratio (OR)|3.664||||0.017|2-Sided|95.0|1.263|10.624|||Regression, Logistic||TAK-063 versus Placebo. The p-values were obtained using a logistic regression model adjusting for treatment and the Baseline PANSS total score.|Week 1|
1614916|NCT02477020|2964295|Superiority or Other||Least square mean difference|-2.44|Standard Error of the Mean|1.732||0.161|2-Sided|95.0|-5.87|0.98||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 6|
1614917|NCT02477020|2964295|Superiority or Other||Least square mean difference|-1.61|Standard Error of the Mean|1.621||0.323|2-Sided|95.0|-4.81|1.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 5|
1614987|NCT02476890|2964318|Other||Mean Difference (Final Values)|-0.22||||0.5993|2-Sided|95.0|-1.1|0.6|||Mixed Models Analysis|||C5 Response/Healthy|
1614988|NCT02476890|2964318|Other||Mean Difference (Final Values)|0.01||||0.9666|2-Sided|95.0|-0.6|0.7|||Mixed Models Analysis|||C2 Response/Healthy|
1614918|NCT02477020|2964295|Superiority or Other||Least square mean difference|-0.37|Standard Error of the Mean|1.625||0.821|2-Sided|95.0|-3.58|2.84||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 4|
1614919|NCT02477020|2964295|Superiority or Other||Least square mean difference|-1.31|Standard Error of the Mean|1.455||0.371|2-Sided|95.0|-4.18|1.57||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 3|
1614920|NCT02477020|2964295|Superiority or Other||Least square mean difference|-0.61|Standard Error of the Mean|1.151||0.596|2-Sided|95.0|-2.89|1.66||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 2|
1614921|NCT02477020|2964295|Superiority or Other||Least square mean difference|0.07|Standard Error of the Mean|0.801||0.933|2-Sided|95.0|-1.52|1.65||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS General Score, Change at Week 1|
1614922|NCT02477020|2964295|Superiority or Other||Least square mean difference|-1.14|Standard Error of the Mean|0.853||0.182|2-Sided|95.0|-2.83|0.54||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 6|
1614923|NCT02477020|2964295|Superiority or Other||Least square mean difference|-0.22|Standard Error of the Mean|0.892||0.807|2-Sided|95.0|-1.98|1.55||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 5|
1614924|NCT02477020|2964295|Superiority or Other||Least square mean difference|-0.37|Standard Error of the Mean|0.856||0.67|2-Sided|95.0|-2.06|1.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 4|
1614925|NCT02477020|2964295|Superiority or Other||Least square mean difference|-0.37|Standard Error of the Mean|0.722||0.612|2-Sided|95.0|-1.79|1.06||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 3|
1614926|NCT02477020|2964295|Superiority or Other||MMRM|-0.59|Standard Error of the Mean|0.693||0.396|2-Sided|95.0|-1.96|0.78||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 2|
1614927|NCT02477020|2964295|Superiority or Other||Least square mean difference|0.06|Standard Error of the Mean|0.504||0.902|2-Sided|95.0|-0.93|1.06||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Negative Score, Change at Week 1|
1614928|NCT02477020|2964295|Superiority or Other||Least square mean difference|-1.6|Standard Error of the Mean|1.094||0.145|2-Sided|95.0|-3.77|0.56||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 6|
1614929|NCT02477020|2964295|Superiority or Other||Least square mean difference|-1.73|Standard Error of the Mean|1.051||0.102|2-Sided|95.0|-3.81|0.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 5|
1614930|NCT02477020|2964295|Superiority or Other||Least square mean difference|-1.2|Standard Error of the Mean|1.014||0.238|2-Sided|95.0|-3.21|0.8||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 4|
1614931|NCT02477020|2964295|Superiority or Other||Least square mean difference|-1.48|Standard Error of the Mean|0.943||0.119|2-Sided|95.0|-3.34|0.38||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 3|
1614989|NCT02476422|2964347|Superiority or Other||Mean Difference (Net)|3.2||||0.211|2-Sided|95.0|-1.8|8.3|||ANCOVA||||
1615141|NCT02469896|2964781|Superiority||||||||||||||||||No statistical data was obtain because no patients died during the trial.
1614932|NCT02477020|2964295|Superiority or Other||Least square mean difference|-0.72|Standard Error of the Mean|0.784||0.359|2-Sided|95.0|-2.27|0.83||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 2|
1614933|NCT02477020|2964295|Superiority or Other||Least square mean difference|-0.7|Standard Error of the Mean|0.59||0.238|2-Sided|95.0|-1.87|0.47||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS subscale score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction and Baseline PANSS subscale score-by-week interaction.|PANSS Positive Score, Change at Week 1|
1614934|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.68|Standard Error of the Mean|0.635||0.288|2-Sided|95.0|-1.93|0.58||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 6|
1614935|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.52|Standard Error of the Mean|0.569||0.36|2-Sided|95.0|-1.65|0.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 5|
1614936|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.32|Standard Error of the Mean|0.59||0.589|2-Sided|95.0|-1.49|0.85||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 4|
1614937|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.49|Standard Error of the Mean|0.522||0.354|2-Sided|95.0|-1.52|0.55||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 3|
1614938|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.41|Standard Error of the Mean|0.502||0.412|2-Sided|95.0|-1.4|0.58||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 2|
1614939|NCT02477020|2964296|Superiority or Other||Least square mean difference|0.25|Standard Error of the Mean|0.397||0.535|2-Sided|95.0|-0.54|1.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Anxiety, Change at Week 1|
1614940|NCT02477020|2964296|Superiority or Other||Least square mean difference|-1.12|Standard Error of the Mean|0.653||0.088|2-Sided|95.0|-2.41|0.17||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 6|
1614941|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.62|Standard Error of the Mean|0.679||0.365|2-Sided|95.0|-1.96|0.73||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 5|
1614942|NCT02477020|2964296|Superiority or Other||Least square mean difference|0.0|Standard Error of the Mean|0.681||0.994|2-Sided|95.0|-1.34|1.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 4|
1614943|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.87|Standard Error of the Mean|0.604||0.153|2-Sided|95.0|-2.06|0.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 3|
1614944|NCT02477020|2964296|Superiority or Other||Least square mean difference|0.03|Standard Error of the Mean|0.504||0.949|2-Sided|95.0|-0.96|1.03||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 2|
1614945|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.32|Standard Error of the Mean|0.469||0.493|2-Sided|95.0|-1.25|0.6||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Hostility, Change at Week 1|
1615059|NCT02473471|2964570|Other||||||>|0.37|||||||t-test, 2 sided|||Day 3|
1615060|NCT02473471|2964570|Other||||||>|0.27|||||||t-test, 2 sided|||Day 1|
1614946|NCT02477020|2964296|Superiority or Other||Least square mean difference|-1.26|Standard Error of the Mean|0.804||0.119|2-Sided|95.0|-2.85|0.33||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 6|
1614947|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.73|Standard Error of the Mean|0.782||0.354|2-Sided|95.0|-2.27|0.82||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 5|
1614948|NCT02477020|2964296|Superiority or Other||Least square mean difference|0.01|Standard Error of the Mean|0.704||0.991|2-Sided|95.0|-1.38|1.4||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 4|
1614949|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.46|Standard Error of the Mean|0.618||0.458|2-Sided|95.0|-1.68|0.76||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 3|
1614950|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.21|Standard Error of the Mean|0.53||0.687|2-Sided|95.0|-1.26|0.83||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 2|
1614951|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.37|Standard Error of the Mean|0.406||0.362|2-Sided|95.0|-1.17|0.43||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Disorganized thoughts, Change at Week 1|
1614952|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.73|Standard Error of the Mean|0.94||0.441|2-Sided|95.0|-2.58|1.13||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 6|
1614953|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.15|Standard Error of the Mean|0.94||0.875|2-Sided|95.0|-2.01|1.71||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 5|
1614954|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.59|Standard Error of the Mean|0.936||0.527|2-Sided|95.0|-2.44|1.26||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 4|
1614955|NCT02477020|2964296|Superiority or Other||Least square mean difference|0.15|Standard Error of the Mean|0.818||0.857|2-Sided|95.0|-1.47|1.76||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 3|
1614956|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.61|Standard Error of the Mean|0.756||0.42|2-Sided|95.0|-2.11|0.88||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 2|
1614957|NCT02477020|2964296|Superiority or Other||Least square mean difference|0.34|Standard Error of the Mean|0.566||0.548|2-Sided|95.0|-0.78|1.46||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Negative symptoms, Change at Week 1|
1614958|NCT02477020|2964296|Superiority or Other||Least square mean difference|-1.9|Standard Error of the Mean|1.119||0.092|2-Sided|95.0|-4.11|0.31||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 6|
1614959|NCT02477020|2964296|Superiority or Other||Least square mean difference|-2.01|Standard Error of the Mean|1.09||0.067|2-Sided|95.0|-4.17|0.14||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 5|
1614960|NCT02477020|2964296|Superiority or Other||Least square mean difference|-1.54|Standard Error of the Mean|1.025||0.135|2-Sided|95.0|-3.56|0.49||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 4|
1614961|NCT02477020|2964296|Superiority or Other||Least square mean difference|-1.94|Standard Error of the Mean|0.959||0.045|2-Sided|95.0|-3.84|-0.05||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 3|
1614962|NCT02477020|2964296|Superiority or Other||Least square mean difference|-1.19|Standard Error of the Mean|0.786||0.132|2-Sided|95.0|-2.74|0.36||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 2|
1614963|NCT02477020|2964296|Superiority or Other||Least square mean difference|-0.73|Standard Error of the Mean|0.562||0.195|2-Sided|95.0|-1.84|0.38||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. PANSS Marder five-factor score was used as a covariate, pooled center, week and treatment as fixed factors, the treatment-by-week interaction, and Baseline PANSS Marder five-factor score-by-week interaction.|Positive symptoms, Change at Week 1|
1614964|NCT02477020|2964297|Superiority or Other||Least square mean difference|-3.91|Standard Error of the Mean|3.231||0.229|2-Sided|95.0|-10.3|2.48||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 5|
1614965|NCT02477020|2964297|Superiority or Other||Least square mean difference|-2.11|Standard Error of the Mean|3.147||0.504|2-Sided|95.0|-8.33|4.11||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 4|
1614966|NCT02477020|2964297|Superiority or Other||Least square mean difference|-3.46|Standard Error of the Mean|2.813||0.221|2-Sided|95.0|-9.02|2.1||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 3|
1614967|NCT02477020|2964297|Superiority or Other||Least square mean difference|-2.22|Standard Error of the Mean|2.229||0.322|2-Sided|95.0|-6.62|2.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using a MMRM.|MMRM||TAK-063 – Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 2|
1614968|NCT02477020|2964297|Superiority or Other||Least square mean difference|-0.79|Standard Error of the Mean|1.508||0.602|2-Sided|95.0|-3.77|2.19||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using MMRM.|MMRM||TAK-063 – Placebo. Baseline PANSS total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.|Change at Week 1|
1614969|NCT02477020|2964298|Superiority or Other||Least square mean difference|-5.46|Standard Error of the Mean|3.442||0.115|2-Sided|95.0|-12.26|1.35||No adjustment for multiple comparisons. Least square means, differences and p-values were obtained using MMRM|MMRM||TAK-063 – Placebo. Baseline Positive and Negative Symptom Scale (PANSS) total score was used as covariate, pooled center, week and treatment as fixed factors, treatment-by-week interaction and Baseline PANSS total score-by-week interaction.||
1614970|NCT02476890|2964312|Other||Mean Difference (Final Values)|-3.6||||0.0075|2-Sided|95.0|-6.2|-1.0|||Mixed Models Analysis|||Cough Frequency Analysis|
1614971|NCT02476890|2964313|Other||Mean Difference (Final Values)|-18.0||||0.002|2-Sided|95.0|-29.1|-7.0|||Mixed Models Analysis|||Urge to Cough VAS Analysis|
1614972|NCT02476890|2964314|Other||Mean Difference (Final Values)|-18.0||||0.0037|2-Sided|95.0|-29.8|-6.2|||Mixed Models Analysis|||Cough Severity VAS Analysis|
1614973|NCT02476890|2964315|Other||Mean Difference (Final Values)|0.28||||0.0023|2-Sided|95.0|0.1|0.4|||Mixed Models Analysis|||C5 Response/Chronic Cough|
1614974|NCT02476890|2964315|Other||Mean Difference (Final Values)|0.3||||0.0011|2-Sided|95.0|0.1|0.5|||Mixed Models Analysis|||C2 Response/Chronic Cough|
1614975|NCT02476890|2964315|Other||Mean Difference (Final Values)|0.23||||0.1798|2-Sided|95.0|-0.1|0.6|||Mixed Models Analysis|||C5 Response/Healthy|
1614976|NCT02476890|2964315|Other||Mean Difference (Final Values)|0.38|||<|0.0001|2-Sided|95.0|0.2|0.5|||Mixed Models Analysis|||C2 Response/Healthy|
1614977|NCT02476890|2964316|Other||Mean Difference (Final Values)|1.3||||0.0067|2-Sided|95.0|0.4|2.2|||Mixed Models Analysis|||C5 Response/Chronic Cough|
1614978|NCT02476890|2964316|Other||Mean Difference (Final Values)|1.54||||0.0006|2-Sided|95.0|0.7|2.4|||Mixed Models Analysis|||C2 Response/Chronic Cough|
1614979|NCT02476890|2964316|Other||Mean Difference (Final Values)|0.88||||0.0029|2-Sided|95.0|0.4|1.4|||Mixed Models Analysis|||C5 Response/Healthy|
1614980|NCT02476890|2964316|Other||Mean Difference (Final Values)|0.89||||0.1125|2-Sided|95.0|-0.2|2.0|||Mixed Models Analysis|||C2 Response/Healthy|
1614981|NCT02476890|2964317|Other||Mean Difference (Final Values)|0.28||||0.4243|2-Sided|95.0|-0.4|1.0|||Mixed Models Analysis|||C5 Response/Chronic Cough|
1614982|NCT02476890|2964317|Other||Mean Difference (Final Values)|0.23||||0.5169|2-Sided|95.0|-0.5|1.0|||Mixed Models Analysis|||C2 Response/Chronic Cough|
1614983|NCT02476890|2964317|Other||Mean Difference (Final Values)|0.3||||0.5473|2-Sided|95.0|-0.7|1.3|||Mixed Models Analysis|||C5 Response/Healthy|
1614990|NCT02476032|2964355|Other|||||||0.05||||||P-values for pairwise group comparisons were adjusted for multiple comparisons using the Tukey method.|t-test, 2 sided|||Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.|
1614991|NCT02476032|2964356|Other|||||||0.05||||||P-values for pairwise group comparisons were adjusted for multiple comparisons using the Tukey method.|t-test, 2 sided|||Within group comparisons: t-tests comparing the mean change to 0 were utilized. P-values less than 0.05 were considered statistically significant. SAS V9.3 (SAS Institute Inc., Cary, NC) was used for analysis. The sample size of 20 participants per group was based on having 90% power to detect a one standard deviation difference between the DO-strip groups and the placebo group means using ANOVA with a 0.05 level of significance.|
1614992|NCT02475655|2964410|Superiority||Risk Ratio (RR)|0.83||||0.59|2-Sided|90.0|0.46|1.48||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Week 5 to Week 12.|
1614993|NCT02475655|2964410|Superiority||Risk Ratio (RR)|0.74||||0.46|2-Sided|90.0|0.37|1.46||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 12.|
1614994|NCT02475655|2964410|Superiority||Risk Ratio (RR)|0.98||||0.94|2-Sided|90.0|0.65|1.49||Not adjusted for multiple comparisons. Two-sided 10% alpha.|GEE|A GEE model for binary data was used to compare changes in iSCA because a substantial proportion of data was below the assay limit.|Risk ratio is Ruxolitinib risk divided by No Study Treatment risk.|Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 5.|
1614995|NCT02475655|2964411|Superiority||Mean Difference (Net)|-112.0||||0.12|2-Sided|90.0|-231.0|5.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|There is no difference between the two arms in the change in CD4+ T cell counts from Week 5 to Week 12.|
1614996|NCT02475655|2964411|Superiority||Mean Difference (Net)|-38.9||||0.54|2-Sided|90.0|-143.0|65.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 12.|
1614997|NCT02475655|2964411|Superiority||Mean Difference (Net)|74.3||||0.14|2-Sided|90.0|-8.23|156.7||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 5.|
1614998|NCT02475655|2964411|Superiority||Mean Difference (Net)|142.1||||0.007|2-Sided|90.0|57.6|227.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 2.|
1614999|NCT02475655|2964415|Superiority||Mean Difference (Net)|1.06||||0.56|2-Sided|90.0|0.9|1.24||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from Week 4/5 to Week 12.|
1615000|NCT02475655|2964415|Superiority||Mean Difference (Net)|0.93||||0.47|2-Sided|90.0|0.79|1.1||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 12.|
1615001|NCT02475655|2964415|Superiority||Mean Difference (Net)|0.88||||0.034|2-Sided|90.0|0.8|0.97||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 4/5.|
1615002|NCT02475655|2964416|Superiority||Mean Difference (Net)|1.37||||0.026|2-Sided|90.0|1.09|1.73||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from Week 4/5 to Week 10/12.|
1615003|NCT02475655|2964416|Superiority||Mean Difference (Net)|1.1||||0.56|2-Sided|90.0|0.84|1.44||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to Week 10/12.|
1615004|NCT02475655|2964417|Superiority||Mean Difference (Net)|4.64||||0.043|2-Sided|90.0|0.88|8.39||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 10/12.|
1615005|NCT02475655|2964417|Superiority||Mean Difference (Net)|11.0||||0.004|2-Sided|90.0|4.84|17.1||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 4/5.|
1615006|NCT02475655|2964417|Superiority||Mean Difference (Net)|4.9||||0.02|2-Sided|90.0|1.46|8.33||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 1/2.|
1615007|NCT02475655|2964419|Superiority||Mean Difference (Net)|3.95||||0.025|2-Sided|90.0|1.08|6.81||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 10/12.|
1615008|NCT02475655|2964419|Superiority||Mean Difference (Net)|8.15|||<|0.001|2-Sided|90.0|4.47|11.8||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 4/5.|
1615009|NCT02475655|2964419|Superiority||Mean Difference (Net)|4.96|||<|0.05|2-Sided|90.0|0.78|9.14||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 1/2.|
1615010|NCT02475655|2964421|Superiority||Mean Difference (Net)|5376.0||||0.52|2-Sided|90.0|-8592.0|19344.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 10/12.|
1615011|NCT02475655|2964421|Superiority||Mean Difference (Net)|27832.0||||0.012|2-Sided|90.0|9849.0|45815.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 4/5.|
1615012|NCT02475655|2964421|Superiority||Mean Difference (Net)|37754.0|||<|0.001|2-Sided|90.0|19609.0|55898.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 1/2.|
1615013|NCT02475655|2964423|Superiority||Mean Difference (Net)|0.15||||0.75|2-Sided|90.0|-0.65|0.95||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 10/12.|
1615014|NCT02475655|2964423|Superiority||Mean Difference (Net)|-0.55||||0.005|2-Sided|90.0|-0.87|-0.23||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 4/5.|
1615015|NCT02475655|2964423|Superiority||Mean Difference (Net)|-0.13||||0.45|2-Sided|90.0|-0.42|0.15||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 1/2.|
1615016|NCT02475655|2964425|Superiority||Mean Difference (Net)|33.6||||0.91|2-Sided|90.0|-461.0|528.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 10/12.|
1615017|NCT02475655|2964425|Superiority||Mean Difference (Net)|-651.0||||0.021|2-Sided|90.0|-1110.0|-192.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 4/5.|
1615018|NCT02475655|2964425|Superiority||Mean Difference (Net)|-679.0||||0.018|2-Sided|90.0|-1146.0|-212.0||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean|Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 1/2.|
1615019|NCT02475655|2964427|Superiority||Mean Difference (Net)|-0.07||||0.016|2-Sided|90.0|-0.11|-0.02||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to 10/12.|
1615020|NCT02475655|2964427|Superiority||Mean Difference (Net)|-0.01||||0.79|2-Sided|90.0|-0.06|0.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 4/5.|
1615021|NCT02475655|2964427|Superiority||Mean Difference (Net)|-0.02||||0.58|2-Sided|90.0|-0.06|0.03||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 1/2.|
1615022|NCT02475655|2964429|Superiority||Mean Difference (Net)|6.35||||0.09|2-Sided|90.0|0.16|12.5||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.||Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to 10/12.|
1615061|NCT02473471|2964571|Other|||||||0.82|||||||t-test, 2 sided|||Day 7|
1615062|NCT02473471|2964571|Other|||||||0.57|||||||t-test, 2 sided|||Day 5|
1615023|NCT02475655|2964429|Superiority||Mean Difference (Net)|1.61||||0.69|2-Sided|90.0|-5.06|8.29||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 4/5.|
1615024|NCT02475655|2964429|Superiority||Mean Difference (Net)|1.31||||0.7|2-Sided|90.0|-4.27|6.9||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib mean minus No Study Treatment mean.|Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 1/2.|
1615025|NCT02475655|2964433|Superiority|||||||0.4||||||Not adjusted for multiple comparisons. One-sided 5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 12.|
1615026|NCT02475655|2964435|Superiority||Mean Difference (Net)|0.85||||0.18|2-Sided|90.0|0.69|1.04||Not adjusted for multiple comparisons. Two-sided 10% alpha.|t-test, 2 sided|2-sample t-test with equal variance.|Mean difference is Ruxolitinib geometric mean minus No Study Treatment geometric mean. All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.|Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to week 4/5.|
1615027|NCT02475655|2964438|Superiority|||||||0.67||||||Not adjusted for multiple comparisons. One-sided 5% alpha.|Fisher Exact|Fisher's Exact Mid P-Value||Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 5.|
1615028|NCT02475564|2964458|Superiority or Other|||||||0.8|||||||Mann-Whitney test||||
1615029|NCT02475564|2964459|Superiority or Other|||||||0.1|||||||Mann-Whitney test||||
1615030|NCT02475564|2964460|Superiority or Other|||||||0.7|||||||Mann-Whitney test|||A sample size of at least 21 patients per arm would be necessary to have a 90% chance of detecting, as significant at the 1% level, a difference of 3 points in a scale of 10 points, between both groups as the primary outcome, after 42 days of treatment.|
1615031|NCT02475395|2964461|Other||Specificity|93.8|||||2-Sided|95.0|89.2|96.5|||||||
1615032|NCT02475395|2964461|Other||Sensitivity|96.7|||||2-Sided|95.0|88.7|99.1|||||||
1615033|NCT02475395|2964462|Other||Specificity|94.9|||||2-Sided|95.0|90.6|97.3|||||||
1615034|NCT02475395|2964462|Other||Sensitivity|95.0|||||2-Sided|95.0|86.3|98.3|||||||
1615035|NCT02475395|2964463|Other||Specificity|93.3|||||2-Sided|95.0|88.7|96.1|||||Specificity is calculated by the percentage of true negative results obtained using Trak compared to reference method. Negative (for subfertility) results are greater than 15 M/mL.||
1615036|NCT02475395|2964463|Other||Sensitivity|90.0|||||2-Sided|95.0|79.9|95.3|||||Sensitivity estimates the percent true positive results obtained by Trak. Positive results are less than 15 M/mL sperm concentration and are part of a sub fertile diagnostic assessment.||
1615037|NCT02474901|2964482|Equivalence|Looked for statistically-significant difference in numbers of adverse events between the two groups, used a p-value of 0.05 as the cutoff value for significance.|||||<|0.05|||||||Chi-squared, Corrected|Groups were compared with Yates-corrected chi-square test or Fisher exact test for binary or categorical variables.|||
1615038|NCT02474082|2964510|Superiority||Odds Ratio (OR)|16.61|||<|0.0001|2-Sided|95.0|7.79|35.4|||Regression, Logistic||||
1615039|NCT02474069|2964521|Superiority or Other||Odds Ratio (OR)|0.74||||0.281|2-Sided|95.0|0.43|1.28|||ANCOVA|||Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error|
1615040|NCT02474069|2964522|Superiority or Other||Odds Ratio (OR)|0.64||||0.087|2-Sided|95.0|0.39|1.07|||ANCOVA|||Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error|
1615041|NCT02473991|2964523|Superiority or Other||||||<|0.01|||||||Regression, Linear|||Null hypothesis In normal pregnant women, placental thickness during third trimesters may be correlated with birth weight at term.|
1615042|NCT02473991|2964524|Superiority or Other||||||<|0.01|||||||Regression, Linear|||Null hypothesis In normal pregnant women, placental thickness during second trimesters may be correlated with birth weight at term.|
1615043|NCT02473965|2964527|Superiority||LS mean difference|1.58|Standard Error of the Mean|12.536|=|0|2-Sided|95.0|-23.52|26.68|||ANCOVA|||Treatment comparison of percent change in daily CS dose from baseline to Week 39. The Analysis of Covariance model included the percent change from baseline in daily CS dose as the dependent variable, treatment as a fixed effect and baseline daily CS dose as covariate.|
1615044|NCT02473965|2964528|Superiority||Odds Ratio (OR)|0.868|||=|0|2-Sided|95.0|0.27|2.787||The statistical inference was tested as 2-sided with alpha=0.05.|Fisher Exact|||An unstratified analysis using Fisher's exact test was used for treatment comparison without adjustment for stratified baseline prednisone equivalent dose level due to the small cell size. The odds ratio and confidence intervals are calculated overall (i.e. all mITT subjects).|
1615045|NCT02473510|2964564|Superiority or Other||Rate Difference|17.9|||||2-Sided|95.0|4.4|29.3||||||Up to Day 15|
1615046|NCT02473510|2964564|Superiority or Other||Rate Difference|16.7|||||2-Sided|95.0|3.6|27.6||||||Up to Day 8|
1615047|NCT02473510|2964565|Superiority or Other||Rate Difference|0.4|||||2-Sided|95.0|-5.2|2.6|||||||
1615048|NCT02473471|2964567|Other||||||<|0.05|||||||Descriptive statistics||||
1615049|NCT02473471|2964568|Other|||||||0.56|||||||t-test, 2 sided|||Day 7|
1615050|NCT02473471|2964568|Other|||||||0.3|||||||t-test, 2 sided|||Day 5|
1615051|NCT02473471|2964568|Other|||||||0.57|||||||t-test, 2 sided|||Day 3|
1615052|NCT02473471|2964568|Other|||||||0.18|||||||t-test, 2 sided|||Day 1|
1615053|NCT02473471|2964569|Other|||||||0.16|||||||t-test, 2 sided||||
1615054|NCT02473471|2964569|Other|||||||0.09|||||||t-test, 2 sided|||Day 5|
1615055|NCT02473471|2964569|Other|||||||0.47|||||||t-test, 2 sided|||Day 3|
1615056|NCT02473471|2964569|Other|||||||0.05|||||||t-test, 2 sided|||Day 1|
1615057|NCT02473471|2964570|Other||||||>|0.05|||||||t-test, 2 sided|||Day 7|
1615058|NCT02473471|2964570|Other||||||>|0.33|||||||t-test, 2 sided|||Day 5|
1615074|NCT02473471|2964574|Other|||||||0.74||||||There was no significant difference in tooth movement between control and MOP sides from baseline to 1st, 2nd and 3rd months. P Value < 0.05 was considered statistically significant.|t-test, 2 sided||||
1615075|NCT02473471|2964575|Other|||||||0.88|||||||t-test, 2 sided||||
1615076|NCT02473471|2964576|Other|||||||0.56|||||||t-test, 2 sided||||
1615077|NCT02473471|2964577|Other|||||||0.76|||||||t-test, 2 sided||||
1615078|NCT02473471|2964578|Other|||||||0.5|||||||t-test, 2 sided||||
1615079|NCT02473471|2964579|Other|The sample size was calculated based on a type I error frequency of 5%. According to the power analysis and assuming a large effect size difference between groups (effect size= 0.8), the power analysis yielded 28 subjects per group at a conventional alpha level (p = 0.05) and desired power (1 - β) of 0.90||||||0.77|||||||t-test, 2 sided||||
1615080|NCT02473367|2964583|Superiority or Other||GLSMR|0.43|||||2-Sided|90.0|0.36|0.51|||||Raltegravir+12 Hrs TUMS/Raltegravir only||
1615081|NCT02473367|2964583|Superiority or Other||GLSMR|0.42|||||2-Sided|90.0|0.34|0.52|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only||
1615082|NCT02473367|2964583|Superiority or Other||GLSMR|0.52|||||2-Sided|90.0|0.45|0.61|||||Raltegravir+TUMS/Raltegravir only||
1615083|NCT02473367|2964584|Superiority or Other||GLSMR|0.98|||||2-Sided|90.0|0.81|1.17|||||Raltegravir+12 Hrs TUMS/Raltegravir only||
1615084|NCT02473367|2964584|Superiority or Other||GLSMR|0.86|||||2-Sided|90.0|0.65|1.15|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only||
1615085|NCT02473367|2964584|Superiority or Other||GLSMR|0.26|||||2-Sided|90.0|0.21|0.32|||||Raltegravir+TUMS/Raltegravir only||
1615086|NCT02473367|2964585|Superiority or Other||GLSMR|0.9|||||2-Sided|90.0|0.8|1.03|||||Raltegravir+12 Hrs TUMS/Raltegravir only||
1615087|NCT02473367|2964585|Superiority or Other||GLSMR|0.86|||||2-Sided|90.0|0.73|1.03|||||Raltegravir+12 Hrs Leader Antacid/Raltegravir only||
1615088|NCT02473367|2964585|Superiority or Other||Geom. least-squares mean ratio (GLSMR)|0.28|||||2-Sided|90.0|0.24|0.32|||||Raltegravir+TUMS/Raltegravir only||
1615089|NCT02473289|2964594|Superiority||Difference of Least Square (LS) Means|-0.8|Standard Error of the Mean|1.67||0.31|2-Sided|75.0|-2.77|1.1||1-sided|MMRM|Here 'MMRM' refers to Mixed-effect Model Using Repeated Measures.|||
1615090|NCT02472795|2964611|Superiority||Mean Difference (Final Values)|-56.452|Standard Error of the Mean|10.541|<|0.0001|2-Sided|95.0|-77.585|-35.32|||ANCOVA||||
1615091|NCT02472795|2964611|Superiority||Mean Difference (Final Values)|-47.278|Standard Error of the Mean|9.329|<|0.0001|2-Sided|95.0|-65.981|-28.574|||ANCOVA||||
1615092|NCT02472795|2964611|Superiority||Mean Difference (Final Values)|-39.311|Standard Error of the Mean|10.096|<|0.0003|2-Sided|95.0|-59.552|-19.069|||ANCOVA||||
1615093|NCT02472795|2964611|Superiority||Mean Difference (Final Values)|-13.214|Standard Error of the Mean|9.626|<|0.1755|2-Sided|95.0|-32.513|6.085|||ANCOVA||||
1615094|NCT02472795|2964613|Superiority||Mean Difference (Final Values)|-0.88|Standard Error of the Mean|0.147|<|0.0001|2-Sided|95.0|-1.173|-0.586|||ANCOVA||||
1615095|NCT02472795|2964613|Superiority||Mean Difference (Final Values)|-0.565|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-0.825|-0.305|||ANCOVA||||
1615096|NCT02472795|2964613|Superiority||Mean Difference (Final Values)|-0.515|Standard Error of the Mean|0.14|<|0.0006|2-Sided|95.0|-0.797|-0.234|||ANCOVA||||
1615097|NCT02472795|2964613|Superiority||Mean Difference (Final Values)|-0.145|Standard Error of the Mean|0.134|<|0.2837|2-Sided|95.0|-0.413|0.123|||ANCOVA||||
1615098|NCT02472795|2964615|Superiority||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.19||0.06|2-Sided|95.0|-0.75|0.02|||ANCOVA||||
1615099|NCT02472795|2964615|Superiority||Mean Difference (Final Values)|-0.57|Standard Error of the Mean|0.19||0.004|2-Sided|95.0|-0.95|-0.19|||ANCOVA||||
1615100|NCT02472795|2964615|Superiority||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.2||0.02|2-Sided|95.0|-0.91|0.09|||ANCOVA||||
1615101|NCT02472795|2964615|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.2||0.39|2-Sided|95.0|-0.56|0.22|||ANCOVA||||
1615102|NCT02472652|2964623|Other||change in prolactin|30.0|||||2-Sided||||||||||
1615103|NCT02472145|2964670|Superiority||Hazard Ratio (HR)|1.04||||0.7817|2-Sided|95.0|0.79|1.37|||Log Rank|||Statistical Analysis 1|
1615104|NCT02472145|2964671|Superiority||Odds Ratio (OR)|1.5||||0.4747|2-Sided|95.0|0.8|2.8|||Chi-squared|||Statistical Analysis 1|
1615105|NCT02471612|2964687|Superiority or Other (legacy)|||||||0.665||||||Comparing the sensitivity of APACHE-II and P-POSSUM|McNemar|||Area under the curve (AUC) is used to measure the “size” of the prediction composed by the graphic display between the ‘sensitivity’ and the ‘1–specificity’ relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value > 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value < 0.60 is regarded as poor.|
1615106|NCT02471404|2964691|Superiority||Hazard Ratio (HR)|0.36|||<|0.001|2-Sided|95.0|0.23|0.57|||Regression, Cox||||
1615107|NCT02471404|2964691|Superiority||Hazard Ratio (HR)|0.95|||<|0.777|2-Sided|95.0|0.67|1.35|||Regression, Cox||||
1615108|NCT02471404|2964692|Superiority||Mean Difference (Final Values)|-0.59|||<|0.001|2-Sided|95.0|-0.88|-0.31|||Mixed Models Analysis||||
1615109|NCT02471404|2964692|Superiority||Mean Difference (Final Values)|-0.13|||<|0.374|2-Sided|95.0|-0.43|0.16|||Mixed Models Analysis||||
1615110|NCT02471404|2964693|Superiority||Mean Difference (Final Values)|-4.91|||<|0.001|2-Sided|95.0|-5.52|-4.29|||Mixed Models Analysis||||
1615111|NCT02471404|2964693|Superiority||Mean Difference (Final Values)|-5.3|||<|0.001|2-Sided|95.0|-5.93|-4.67|||Mixed Models Analysis||||
1615112|NCT02471404|2964694|Superiority||Risk Difference (RD)|-3.89|Standard Error of the Mean|1.19|<|0.001|2-Sided|95.0|-6.21|-1.56|||Fisher Exact||||
1615113|NCT02471404|2964694|Superiority||Risk Difference (RD)|-4.21|Standard Error of the Mean|1.14|<|0.001|2-Sided|95.0|-6.45|-1.97|||Fisher Exact||||
1615114|NCT02471404|2964695|Non-Inferiority|The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% Confidence Interval of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.|Mean Difference (Final Values)|-0.21||||0.001|2-Sided|95.0|-0.3443|-0.0825||(superiority)|Mixed Models Analysis||||
1615115|NCT02471404|2964695|Non-Inferiority|The non-inferiority (NI) margin was determined to be 0.30% (in absolute terms). A difference of ≤0.30%, in HbA1c change from b/l to wk 52 between the treatment groups was considered clinically equivalent. NI was assessed using the 2-sided 95% CI of adjusted mean difference between dapagliflozin or dapagliflozin plus saxagliptin and glimepiride.|Mean Difference (Final Values)|0.16|||||2-Sided|95.0|0.0294|0.2986|||||||
1615116|NCT02470806|2964720|Non-Inferiority|Stepwise regression method - Primary efficacy analysis, difference between treatment groups in percentage change in wound area from baseline visit to end of 12-week treatment period for the PP population.||||||0.001|||||||Stepwise regression|||Percentage change in wound area from Baseline to end of 12-week treatment period (PP population - all wounds)|
1615117|NCT02470741|2964732|Superiority||Mean Difference (Net)|-11.85||||0.24|2-Sided|95.0|-32.92|9.23|||Mixed Models Analysis|Repeated measures mixed models, with unstructured co-variance matrix.|Model generated LS Mean Differences|Null hypotheses: Letrozole is not associated with an improvement in the UFSQOL Overall Score.|
1615118|NCT02470403|2964756|Superiority or Other||Mean Difference (Net)|-2.38|||<|0.001|2-Sided|80.0|-2.93|-1.83|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~upper confidence limit of 80% CI for treatment difference was less than 0, and~estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%"|
1615119|NCT02470403|2964756|Superiority or Other||Mean Difference (Net)|-2.39|||<|0.001|2-Sided|80.0|-2.94|-1.84|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~upper confidence limit of 80% CI for treatment difference was less than 0, and~estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."|
1615120|NCT02470403|2964756|Superiority or Other||Mean Difference (Net)|-1.83|||<|0.001|2-Sided|80.0|-2.16|-1.51|||Mixed Models Analysis|||"This analysis on all subjects. The following criteria were assessed:~upper confidence limit of 80% CI for treatment difference was less than 0, and~estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."|
1615121|NCT02470403|2964758|Superiority or Other||Mean Difference (Net)|-4.55|||<|0.001|2-Sided|80.0|-5.76|-3.34|||Mixed Models Analysis|||"This analysis included normoglycemic subjects. The following criteria were assessed:~upper confidence limit of 80% CI for treatment difference was less than 0, and~estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."|
1615122|NCT02470403|2964758|Superiority or Other||Mean Difference (Net)|-6.85|||<|0.001|2-Sided|80.0|-7.96|-5.73|||Mixed Models Analysis|||"This analysis included dysglycemic subjects. The following criteria were assessed:~upper confidence limit of 80% CI for treatment difference was less than 0, and~estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."|
1615123|NCT02470403|2964758|Superiority or Other||Mean Difference (Net)|-5.7|||<|0.001|2-Sided|80.0|-6.52|-4.87|||Mixed Models Analysis|||"This analysis included all subjects. The following criteria were assessed:~upper confidence limit of the 80% CI for treatment difference (LIK066 - placebo) was less than 0, and~estimated mean treatment difference was less than or equal to -5%. The first criterion addressed whether, with high certainty, there was superior weight loss in LIK066 treated group compared to placebo. The second criterion addressed whether observed mean reduction in body weight over placebo was at least 5%."|
1615124|NCT02469896|2964774|Superiority||Ratio of fold change|1.785|||<|0.001|2-Sided|95.0|1.502|2.121|||Mixed Models Analysis||||
1615125|NCT02469896|2964775|Superiority||Ratio of fold change|1.078||||0.697|2-Sided|95.0|0.728|1.595|||Mixed Models Analysis||||
1615126|NCT02469896|2964775|Superiority||Ratio of fold change|1.078||||0.587|2-Sided|95.0|0.813|1.431|||Mixed Models Analysis||||
1615127|NCT02469896|2964775|Superiority||Ratio of fold change|2.94|||<|0.001|2-Sided|95.0|1.823|4.74|||Mixed Models Analysis||||
1615128|NCT02469896|2964775|Superiority||Ratio of fold change|0.741|||<|0.604|2-Sided|95.0|0.228|2.405|||Mixed Models Analysis||||
1615129|NCT02469896|2964775|Superiority||Ratio of fold change|0.167|||<|0.011|2-Sided|95.0|0.043|0.643|||Mixed Models Analysis||||
1615130|NCT02469896|2964776|Superiority||Ratio of fold change|0.893||||0.285|2-Sided|95.0|0.725|1.1|||Mixed Models Analysis||||
1615131|NCT02469896|2964776|Superiority||Ratio of fold change|1.396||||0.427|2-Sided|95.0|0.608|3.206|||Mixed Models Analysis||||
1615132|NCT02469896|2964776|Superiority||Ratio of fold change|1.264||||0.185|2-Sided|95.0|0.892|1.791|||Mixed Models Analysis||||
1615133|NCT02469896|2964776|Superiority||Ratio of fold change|19.591|||<|0.001|2-Sided|95.0|11.143|34.446|||Mixed Models Analysis||||
1615134|NCT02469896|2964776|Superiority||Ratio of fold change|1.306|||<|0.247|2-Sided|95.0|0.828|2.059|||Mixed Models Analysis||||
1615135|NCT02469896|2964776|Superiority||Ratio of fold change|0.047|||<|0.001|2-Sided|95.0|0.01|0.217|||Mixed Models Analysis||||
1615136|NCT02469896|2964777|Superiority||Ratio of geometric means|1.198||||0.5|2-Sided|95.0|0.691|2.08|||t-test, 2 sided||||
1615137|NCT02469896|2964777|Superiority||Ratio of geometric means|1.344||||0.663|2-Sided|95.0|0.331|2.08|||t-test, 2 sided||||
1615138|NCT02469896|2964777|Superiority||Ratio of geometric means|1.15||||0.684|2-Sided|95.0|0.566|2.337|||t-test, 2 sided|||PBMC IL-6 fold-change|
1615139|NCT02469896|2964779|Superiority||Difference of slopes|-0.008||||0.983|2-Sided|95.0|-0.761|0.745|||Mixed Models Analysis||||
1615140|NCT02469896|2964780|Superiority||Slope|0.099||||0.922|2-Sided|95.0|-1.902|2.099||Unadjusted|Mixed Models Analysis||||
1615543|NCT02451839|2966007|Superiority||||||<|0.001|||||||paired t-test||||
1615142|NCT02469896|2964782|Superiority||Risk Ratio (RR)|0.875||||0.602|2-Sided|95.0|0.556|1.377|||Fisher Exact||||
1615143|NCT02469870|2964783|Superiority|||||||0.045|||||||t-test, 2 sided|||Two-sample t-test|
1615144|NCT02469870|2964784|Superiority|||||||0.007|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.|
1615145|NCT02469870|2964785|Superiority|||||||0.246|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.|
1615146|NCT02469870|2964786|Superiority|||||||0.404|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.|
1615147|NCT02469870|2964787|Superiority|||||||0.81|||||||ANCOVA|||. To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.|
1615148|NCT02469870|2964788|Superiority|||||||0.598|||||||ANCOVA|||To address hypotheses predicting differential change in outcome measures between condition over time we used analysis of covariance (ANCOVA) models that allow for examination of cross-sectional effects and mean adjusted outcomes. The ANCOVA models (adjusted for baseline scores) were used for analyses of change in the outcome measures at posttest.|
1615149|NCT02469714|2964789|Superiority||Mean Difference (Final Values)|0.95||||0.21|2-Sided||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.|
1615150|NCT02469714|2964790|Superiority||Mean Difference (Final Values)|0.93||||0.34|2-Sided||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.|
1615151|NCT02469714|2964791|Superiority||Mean Difference (Final Values)|1.03||||0.073|2-Sided||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.|
1615152|NCT02469714|2964792|Superiority||Mean Difference (Final Values)|1.05||||0.06|2-Sided||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.|
1615153|NCT02469714|2964793|Superiority||Mean Difference (Final Values)|1.0||||0.0005|2-Sided||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.|
1615154|NCT02469714|2964794|Superiority||Mean Difference (Final Values)|0.99||||0.077|2-Sided||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.|
1615155|NCT02469714|2964795|Superiority||Mean Difference (Final Values)|0.99||||0.135|2-Sided||||||ANCOVA|||This statistical analysis applies from baseline to 12 month.|
1615156|NCT02469714|2964796|Superiority||Mean Difference (Final Values)|0.61||||0.008|2-Sided||||||ANCOVA|||Between group comparison of total achieved appointments from 1-13 months|
1615157|NCT02469714|2964796|Superiority||Mean Difference (Final Values)|0.66||||0.04|2-Sided||||||ANCOVA|||Between group comparison of total scheduled appointments from 1-13 months|
1615158|NCT02469246|2964842|Superiority||Difference in LSM|-0.056||||0.89|2-Sided|95.0|-0.825|0.713||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).||
1615159|NCT02469246|2964843|Superiority||Difference in LSM|0.151||||0.63|2-Sided|95.0|-0.465|0.767||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).||
1615160|NCT02469246|2964844|Superiority||Difference in LSM|0.165||||0.53|2-Sided|95.0|-0.348|0.678||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).||
1615161|NCT02469246|2964845|Superiority||Difference in LSM|0.179||||0.4|2-Sided|95.0|-0.24|0.598||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).||
1615162|NCT02469246|2964846|Superiority||Difference in LSM|-39.0||||0.013|2-Sided|95.0|-70.0|-8.0||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).||
1615163|NCT02469246|2964847|Superiority||Difference in LSM|-32.0||||0.026|2-Sided|95.0|-61.0|-4.0||P-value was adjusted by the third agent stratum (boosted protease inhibitors vs. others).|ANOVA||Difference in LSM and its 95% CI were adjusted by the third agent stratum (boosted protease inhibitors vs. others).||
1615164|NCT02469246|2964848|Non-Inferiority|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.|Difference in Percentages|-5.9||||0.069|2-Sided|95.0|-12.2|0.4|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.|
1615165|NCT02469246|2964849|Non-Inferiority|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 10%.|Difference in Percentages|-1.6||||0.62|2-Sided|95.0|-7.4|4.2|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.|
1615200|NCT02468674|2964898|Other|||||||0.839|||||||ANCOVA|Difference in the least square means (SE)||Population II: SPPB total score at Week 49|
1615201|NCT02468674|2964899|Other|||||||0.53|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49|
1615544|NCT02451839|2966008|Superiority||||||<|0.001|||||||paired t-test||||
1615166|NCT02469246|2964850|Non-Inferiority|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|1.4||||0.34|2-Sided|95.0|-1.0|4.2|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.|
1615167|NCT02469246|2964851|Non-Inferiority|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|1.1||||0.45|2-Sided|95.002|-1.0|3.5|||Fisher Exact||The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.|
1615168|NCT02469246|2964852|Non-Inferiority|Non-inferiority was assessed using a 2-sided exact 95% CI approach, with a non-inferiority margin of 4%.|Difference in Percentages|-6.3||||0.042|2-Sided|95.0|-12.3|-0.3|||Fisher Exact||The difference in percentages and its 95% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of this efficacy endpoint was to assess the non-inferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.|
1615169|NCT02469246|2964853|Non-Inferiority|Non-inferiority was assessed using a 2-sided exact 95% confidence interval (CI) approach, with a non-inferiority margin of 10%.|Difference in Percentages|-3.8||||0.15|2-Sided|95.002|-8.9|1.1|||Fisher Exact||The difference in percentages and its 95.002% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The analysis purpose of the primary efficacy endpoint was to assess the noninferiority of switching to F/TAF+3rd Agent relative to maintaining treatment with ABC/3TC+3rd Agent.|
1615170|NCT02469064|2964863|Other||Slope|0.46||||0.48|2-Sided|95.0|-3.75|4.78|||t-test, 2 sided||The slope shows the difference between the means of the change in the MIP of the group that received the experimental treatment and the group that received the conventional treatment||
1615171|NCT02469064|2964864|Other||Hazard Ratio (HR)|0.82||||0.84|2-Sided|95.0|0.55|1.2|||Mann Whitneey||Univariate analysis of the probability of extubation was performed using Kaplan-Meir survival analysis and the logrank test.The multivariate analysis was performed by cox regression, a simple model was performed and a final model.||
1615172|NCT02468674|2964890|Other|||||||1|||||||ANCOVA|Difference in the least square geometric means||Population II: LBM at Week 49|
1615173|NCT02468674|2964891|Other|||||||0.227|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49|
1615174|NCT02468674|2964891|Other|||||||0.179|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49|
1615175|NCT02468674|2964891|Other|||||||0.018|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49|
1615176|NCT02468674|2964891|Other|||||||0.323|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49|
1615177|NCT02468674|2964891|Other|||||||0.283|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49|
1615178|NCT02468674|2964891|Other|||||||0.084|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: LBM at Week 49|
1615179|NCT02468674|2964892|Other|||||||1|||||||ANCOVA|Difference in the least square geometric means||Population II: ASMI at Week 49|
1615180|NCT02468674|2964893|Other|||||||0.211|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49|
1615181|NCT02468674|2964893|Other|||||||0.106|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49|
1615182|NCT02468674|2964893|Other|||||||0.022|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49|
1615183|NCT02468674|2964893|Other|||||||0.074|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49|
1615184|NCT02468674|2964893|Other|||||||0.297|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49|
1615185|NCT02468674|2964893|Other|||||||0.12|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: ASMI at Week 49|
1615186|NCT02468674|2964894|Other|||||||0.395|||||||ANCOVA|Difference in the least square means (SE)||Population II: Gait speed at Week 49|
1615187|NCT02468674|2964895|Other|||||||0.321|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49|
1615188|NCT02468674|2964895|Other|||||||0.31|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49|
1615189|NCT02468674|2964895|Other|||||||0.632|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49|
1615190|NCT02468674|2964895|Other|||||||0.168|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49|
1615191|NCT02468674|2964895|Other|||||||0.909|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49|
1615192|NCT02468674|2964895|Other|||||||0.875|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: Gait speed at Week 49|
1615193|NCT02468674|2964896|Other|||||||0.367|||||||ANCOVA|Difference in the least square means (SE)||Population II: 6MWT at Week 49|
1615194|NCT02468674|2964897|Other|||||||0.84|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49|
1615195|NCT02468674|2964897|Other|||||||0.885|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49|
1615196|NCT02468674|2964897|Other|||||||0.766|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49|
1615197|NCT02468674|2964897|Other|||||||0.29|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49|
1615198|NCT02468674|2964897|Other|||||||0.773|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49|
1615199|NCT02468674|2964897|Other|||||||0.669|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: 6MWT at Week 49|
1615202|NCT02468674|2964899|Other|||||||0.929|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49|
1615203|NCT02468674|2964899|Other|||||||0.648|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49|
1615204|NCT02468674|2964899|Other|||||||0.144|||||||t-test, 1 sided|One-sided test at the 0.025 significance||Population I: SPPB total score at Week 49|
1615205|NCT02468674|2964899|Other|||||||0.5|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49|
1615206|NCT02468674|2964899|Other|||||||0.759|||||||t-test, 1 sided|One-sided test at the 0.025 significance level.||Population I: SPPB total score at Week 49|
1615207|NCT02467842|2964965|Superiority|Superiority was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator-experimental) was ≤0% in each B strain.|Difference in percentage|-12.62|||||2-Sided|95.0|-18.79|-6.45||||||Diff. SCR of B/Victoria strain (SCR of TIV minus QIV)|
1615208|NCT02467842|2964965|Superiority|Superiority was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator-experimental) was ≤0% in each B strain.|Difference in percentage|-18.98|||||2-Sided|95.0|-24.61|-13.36||||||Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)|
1615209|NCT02467842|2964966|Superiority|Superiority of GMTs was concluded if the upper limit of 95% confidence interval for GMR (active comparator/experimental) was ≤1.0 for each B strain.|GMR (TIV/QIV)|0.75|||||2-Sided|95.0|0.69|0.81||||||GMR of B/Victoria (GMTs of TIV/QIV)|
1615210|NCT02467842|2964966|Superiority|Superiority of GMTs was concluded if the upper limit of 95% confidence interval for GMR (active comparator/experimental) was ≤1.0 for each B strain.|GMR (TIV/QIV)|0.75|||||2-Sided|95.0|0.7|0.81||||||GMR of B/Yamagata strain (GMTs of TIV/QIV)|
1615211|NCT02467842|2964970|Non-Inferiority|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-3.09|||||2-Sided|95.0|-9.26|3.09||||||Diff. SCR of B/Victoria (SCR of TIV minus QIV)|
1615212|NCT02467842|2964970|Non-Inferiority|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-7.06|||||2-Sided|95.0|-13.12|-1.0||||||Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)|
1615213|NCT02467842|2964970|Non-Inferiority|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-5.02|||||2-Sided|95.0|-10.08|0.04||||||Diff. SCR of A/H3N2 strain (SCR of pooled TIV minus QIV)|
1615214|NCT02467842|2964970|Non-Inferiority|Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain.|Difference in percentage|-1.0|||||2-Sided|95.0|-6.07|4.06||||||Diff. SCR of A/H1N1 strain (SCR of pooled TIV minus QIV)|
1615215|NCT02467842|2964971|Non-Inferiority|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (TIV/QIV)|0.9|||||2-Sided|95.0|0.83|0.97||||||GMR of A/H1N1 strain (GMTs of TIV/QIV)|
1615216|NCT02467842|2964971|Non-Inferiority|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (TIV/QIV)|0.88|||||2-Sided|95.0|0.82|0.95||||||GMR of B/Yamagata strain (GMTs of TIV/QIV)|
1615217|NCT02467842|2964971|Non-Inferiority|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (pooled TIV/QIV)|0.94|||||2-Sided|95.0|0.87|1.01||||||GMR of A/H3N2 strain (GMTs of pooled TIV/QIV)|
1615218|NCT02467842|2964971|Non-Inferiority|Non-inferiority of GMTs was concluded if the upper limit of 95% confidence interval of the GMR (active comparator/experimental) was ≤1.5 for each strain.|GMR (pooled TIV/QIV)|1.02|||||2-Sided|95.0|0.94|1.1||||||GMR of A/H1N1 strain (GMTs of pooled TIV/QIV)|
1615219|NCT02467504|2964982|Other|||||||0.156|||||||Wilcoxon (Mann-Whitney)||||
1615220|NCT02467504|2964983|Other|||||||0.039|||||||Wilcoxon (Mann-Whitney)||||
1615221|NCT02467504|2964984|Other|||||||0.055|||||||Wilcoxon (Mann-Whitney)||||
1615222|NCT02467504|2964985|Other|||||||0.422|||||||Mixed Models Analysis||||
1615223|NCT02467504|2964986|Other|||||||0.881|||||||Mixed Models Analysis||||
1615224|NCT02467504|2964987|Other|||||||0.74|||||||Wilcoxon (Mann-Whitney)||||
1615225|NCT02467504|2964988|Other|||||||0.085|||||||Wilcoxon (Mann-Whitney)||||
1615226|NCT02467504|2964989|Other|||||||0.221|||||||Wilcoxon (Mann-Whitney)||||
1615227|NCT02467504|2964990|Other|||||||0.565|||||||Chi-squared||||
1615228|NCT02467504|2964991|Other|||||||0.373|||||||Chi-squared||||
1615229|NCT02467504|2964992|Other|||||||0.2|||||||Chi-squared||||
1615230|NCT02467504|2964993|Other|||||||0.616|||||||Chi-squared||||
1615231|NCT02467504|2964994|Other|||||||0.616|||||||Chi-squared||||
1615232|NCT02467504|2964995|Other|description of Treg cells in CD4+ T cells||||||0.665|||||||Mixed Models Analysis||||
1615233|NCT02467504|2964996|Other|Chi||||||0.474|||||||Chi-squared||||
1615234|NCT02467504|2964997|Other|||||||0.015|||||||Mixed Models Analysis||||
1615235|NCT02467504|2964998|Other|||||||0.018|||||||Mixed Models Analysis||||
1615236|NCT02467504|2964999|Other|||||||0.315|||||||Chi-squared||||
1615237|NCT02467504|2965000|Other|||||||0.53|||||||Chi-squared||||
1615238|NCT02467491|2965001|Superiority or Other|||||||0.02|||||||t-test, 2 sided|||The Short Physical Performance Battery (SPPB) score after 4 weeks of physical activity intervention was compared with the SPPB score after 2 to 3 months from the completion of the physical activity intervention with a paired t-test|
1615239|NCT02467491|2965002|Superiority or Other|||||||0.04|||||||t-test, 2 sided|||The Short Physical Performance Battery (SPPB) score at baseline was compared with the SPPB scored after 4 weeks of physical activity intervention with a paired t-test|
1615240|NCT02466425|2965029|Superiority or Other||LS Mean difference|-9.9|Standard Error of the Mean|1.59|<|0.001|2-Sided|95.0|-13.0|-6.8|||Mixed-effects model for repeated measure||Between treatment groups||
1615296|NCT02462291|2965229|Superiority or Other||Mean Difference (Final Values)|0.06||||0.84|2-Sided|95.0|-1.14|1.27|||ANOVA|||Baseline|
1615241|NCT02466412|2965030|Superiority or Other (legacy)||Geometric LS Mean Ratio|60.0052|||||2-Sided|95.0|44.9517|80.0997|||||"Geometric LS mean ratio (CHTP 1.1 M:mCC).~Expressed as %"|The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for AUC(0-last). Therefore, there was no statistical hypothesis to be tested for this objective.|
1615242|NCT02466412|2965031|Superiority or Other (legacy)||Geometric LS Mean Ratio|63.9326|||||2-Sided|95.0|49.6045|82.3991|||||"Geometric LS mean ratio (CHTP 1.1 M:mCC).~Expressed as %"|The objective of this study was to determine the point estimate and precision of the CHTP 1.1 M:mCC ratio for Cmax. Therefore, there was no statistical hypothesis to be tested for this objective.|
1615243|NCT02466087|2965041|Other||diiference in differences|1.5|||||2-Sided|95.0|||||||||
1615244|NCT02465931|2965042|Other|||||||0.89|||||||t-test, 1 sided||||
1615245|NCT02465515|2965069|Other||Mean Difference (Net)|-0.43||||0.315|2-Sided|95.0|-1.26|0.41||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16.||
1615246|NCT02465515|2965069|Other||Mean Difference (Net)|-1.11||||0.003|2-Sided|95.0|-1.84|-0.39||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline eGFR+Treatment+Visit+Treatment-by-Visit Interaction+Baseline eGFR-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8.||
1615247|NCT02465515|2965073|Other||Hazard Ratio (HR)|0.95||||0.644|2-Sided|95.0|0.79|1.16||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.||
1615248|NCT02465515|2965074|Other||Mean Difference (Net)|0.52||||0.192|2-Sided|95.0|-0.26|1.31||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide - Placebo) is from MMRM model for Month 16||
1615249|NCT02465515|2965074|Other||Mean Difference (Net)|1.47|||<|0.001|2-Sided|95.0|0.87|2.07||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8.||
1615250|NCT02465515|2965075|Other||Mean Difference (Net)|2.33|||<|0.001|2-Sided|95.0|1.66|3.01||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16||
1615251|NCT02465515|2965075|Other||Mean Difference (Net)|2.39|||<|0.001|2-Sided|95.0|1.85|2.93||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero.|t-test, 2 sided||Based on MMRM model: Change=Baseline Total Score+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Total Score-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8||
1615252|NCT02465515|2965076|Other||Mean Difference (Net)|-0.83|||<|0.001|2-Sided|95.0|-1.06|-0.6||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16||
1615253|NCT02465515|2965076|Other||Mean Difference (Net)|-0.66|||<|0.001|2-Sided|95.0|-0.83|-0.49||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide-Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline Body Weight+Treatment+Visit+Treatment-by-Visit Interaction+Baseline Body Weight-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8||
1615254|NCT02465515|2965077|Other||Mean Difference (Net)|-0.52|||<|0.001|2-Sided|95.0|-0.58|-0.45||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 16||
1615255|NCT02465515|2965077|Other||Mean Difference (Net)|-0.63|||<|0.001|2-Sided|95.0|-0.69|-0.58||P-value from a two-sided t-test to test whether the difference of least square means (Albiglutide - Placebo) is equal to zero|t-test, 2 sided||Based on MMRM model: Change=Baseline HbA1c+Treatment+Visit+Treatment-by-Visit Interaction+Baseline HbA1c-by-Visit Interaction. Difference of least squares means (Albiglutide-Placebo) is from MMRM model for Month 8||
1615256|NCT02465515|2965078|Superiority||Hazard Ratio (HR)|0.66||||0.055|2-Sided|95.0|0.43|1.01||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.||
1615257|NCT02465515|2965079|Other||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (<8.0% versus >= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Final assessment|||
1615258|NCT02465515|2965079|Other||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (<8.0% versus >= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 24|||
1615259|NCT02465515|2965079|Other||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (<8.0% versus >= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 16|||
1615260|NCT02465515|2965079|Other||||||<|0.001||||||P-value based on the covariate-adjusted extended Mantel-Haenszel test. Covariates include Baseline HbA1c (<8.0% versus >= 8.0%) and Baseline diabetes therapy (diet and exercise alone versus all other therapies).|Mantel Haenszel|Month 8|||
1615261|NCT02465515|2965080|Superiority||Hazard Ratio (HR)|0.71||||0.043|2-Sided|95.0|0.51|0.99||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.||
1615262|NCT02465515|2965081|Superiority||Hazard Ratio (HR)|0.42|||<|0.001|2-Sided|95.0|0.33|0.53||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.||
1615263|NCT02465515|2965082|Other||Hazard Ratio (HR)|0.85||||0.113|2-Sided|95.0|0.7|1.04||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.||
1615264|NCT02465515|2965083|Other||Hazard Ratio (HR)|0.86||||0.3|2-Sided|95.0|0.66|1.14||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.||
1615265|NCT02465515|2965084|Other||Hazard Ratio (HR)|0.75||||0.003|2-Sided|95.0|0.61|0.9||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.||
1615266|NCT02465515|2965085|Other||Hazard Ratio (HR)|0.93||||0.578|2-Sided|95.0|0.73|1.19||Two-sided p-value based on the Wald statistic|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate||
1615267|NCT02465515|2965086|Other||Hazard Ratio (HR)|0.78|||<|0.001|2-Sided|95.0|0.69|0.9||Two-sided p-value based on the Wald statistic.|Wald statistic||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate.||
1615268|NCT02465515|2965087|Superiority||||||<|0.001||||||Two-sided p-value based on Wald test of HR=1 versus HR not equal to 1|Wald test||||
1615269|NCT02465515|2965087|Non-Inferiority|Non-inferiority was determined by testing the hypothesis that the observed hazard ratio is significantly different from the null margin of 1.3 (a one-sided p <0.025 for such a test with result in appropriate direction being equivalent to the upper 95% confidence limit for the hazard ratio being less than 1.3)|Hazard Ratio (HR)|0.78|||<|0.0001|2-Sided|95.0|0.68|0.9||One-sided p-value based on Wald test of hazard ratio (HR) >=1.3 versus HR <1.3.|Wald test||Hazard ratio is estimated using a Cox proportional hazard regression model with treatment as the only covariate||
1615270|NCT02463071|2965187|Superiority||Mean Difference (Final Values)|-32.92|Standard Error of the Mean|5.04|<|0.0001|2-Sided|95.0|-42.93|-22.92|||ANCOVA|Baseline TG and statin usage were included as covariates.|||
1615271|NCT02463071|2965187|Superiority||Mean Difference (Final Values)|-26.72|Standard Error of the Mean|4.96|<|0.0001|2-Sided|95.0|-36.55|-16.88|||ANCOVA|Baseline TG and statin usage were included as covariates.|||
1615272|NCT02462291|2965220|Superiority or Other||Chi-squared value|1.049||||0.789|2-Sided||||||Chi-squared||Power of performed test with alpha = 0.050: 0.116; 3 degrees of freedom||
1615273|NCT02462291|2965221|Superiority or Other||Chi-squared value|0.008||||1|2-Sided||||||Chi-squared||Power of performed test with alpha = 0.050: 0.050; 3 degrees of freedom||
1615274|NCT02462291|2965222|Superiority or Other||Chi-squared value|5.749||||0.124|2-Sided||||||Chi-squared||Power of performed test with alpha = 0.050: 0.488; 3 degrees of freedom||
1615275|NCT02462291|2965223|Superiority or Other||Chi-squared value|17.73|||<|0.001|2-Sided||||||Chi-squared||Power of performed test with alpha = 0.050: 0.965; 3 degrees of freedom||
1615276|NCT02462291|2965224|Superiority or Other||Chi-squared value|0.542|||=|0|2-Sided||||||Chi-squared||Power of performed test with alpha = 0.050: 0.082; 3 degrees of freedom||
1615277|NCT02462291|2965225|Superiority or Other||Mean Difference (Final Values)|0.24||||0.87|2-Sided|95.0|-0.31|0.81|||ANOVA|||PRE Vs POST|
1615278|NCT02462291|2965225|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.013|2-Sided|95.0|-1.21|-0.09|||ANOVA|||PRE Vs POST|
1615279|NCT02462291|2965225|Superiority or Other||Mean Difference (Final Values)|0.72||||0.005|2-Sided|95.0|0.15|1.29|||ANOVA|||After the treatment|
1615280|NCT02462291|2965225|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.83|2-Sided|95.0|-0.72|0.37|||ANOVA|||Baseline|
1615281|NCT02462291|2965226|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.88|2-Sided|95.0|-1.17|0.59|||ANOVA|||PRE Vs POST|
1615282|NCT02462291|2965226|Superiority or Other||Mean Difference (Final Values)|-2.92|||<|0.01|2-Sided|95.0|-3.8|-2.04|||ANOVA|||PRE Vs POST|
1615283|NCT02462291|2965226|Superiority or Other||Mean Difference (Final Values)|2.86|||<|0.01|2-Sided|95.0|1.96|3.76|||ANOVA|||After the treatment|
1615284|NCT02462291|2965226|Superiority or Other||Mean Difference (Final Values)|0.23|||<|0.9|2-Sided|95.0|-0.64|1.09|||ANOVA|||Baseline|
1615285|NCT02462291|2965227|Superiority or Other||Mean Difference (Final Values)|-1.04||||0.69|2-Sided|95.0|-5.28|3.19|||ANOVA|||PRE Vs POST|
1615286|NCT02462291|2965227|Superiority or Other||Mean Difference (Final Values)|0.63||||0.59|2-Sided|95.0|-3.57|4.82|||ANOVA|||PRE Vs POST|
1615287|NCT02462291|2965227|Superiority or Other||Mean Difference (Final Values)|-1.25||||0.82|2-Sided|95.0|-5.54|3.04|||ANOVA|||After the treatment|
1615288|NCT02462291|2965227|Superiority or Other||Mean Difference (Final Values)|0.41||||0.74|2-Sided|95.0|-3.73|4.56|||ANOVA|||Baseline|
1615289|NCT02462291|2965228|Superiority or Other||Mean Difference (Final Values)|-6.6||||0.84|2-Sided|95.0|-67.7|54.5|||ANOVA|||PRE Vs POST|
1615290|NCT02462291|2965228|Superiority or Other||Mean Difference (Final Values)|-29.7||||0.78|2-Sided|95.0|-90.19|30.78|||ANOVA|||PRE Vs POST|
1615291|NCT02462291|2965228|Superiority or Other||Mean Difference (Final Values)|8.36||||0.87|2-Sided|95.0|-53.47|70.2|||ANOVA|||After the treatment|
1615292|NCT02462291|2965228|Superiority or Other||Mean Difference (Final Values)|-14.7||||0.94|2-Sided|95.0|-74.4|44.9|||ANOVA|||Baseline|
1615293|NCT02462291|2965229|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.75|2-Sided|95.0|-1.49|0.97|||ANOVA|||PRE Vs POST|
1615294|NCT02462291|2965229|Superiority or Other||Mean Difference (Final Values)|-0.48||||0.86|2-Sided|95.0|-1.71|0.74|||ANOVA|||PRE Vs POST|
1615295|NCT02462291|2965229|Superiority or Other||Mean Difference (Final Values)|0.28||||0.81|2-Sided|95.0|-0.96|1.54|||ANOVA|||After the treatment|
1615297|NCT02462291|2965230|Superiority or Other||Mean Difference (Final Values)|0.46||||0.15|2-Sided|95.0|-0.08|1.01|||ANOVA|||PRE Vs POST|
1615298|NCT02462291|2965230|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.96|2-Sided|95.0|-0.65|0.44|||ANOVA|||PRE Vs POST|
1615299|NCT02462291|2965230|Superiority or Other||Mean Difference (Final Values)|0.43||||0.23|2-Sided|95.0|-0.12|0.99|||ANOVA|||After the treatment|
1615300|NCT02462291|2965230|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.95|2-Sided|95.0|-0.67|0.4|||ANOVA|||Baseline|
1615301|NCT02462291|2965231|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.95|2-Sided|95.0|-1.78|1.39|||ANOVA|||PRE Vs POST|
1615302|NCT02462291|2965231|Superiority or Other||Mean Difference (Final Values)|0.4||||0.88|2-Sided|95.0|-1.17|1.98|||ANOVA|||PRE Vs POST|
1615303|NCT02462291|2965231|Superiority or Other||Mean Difference (Final Values)|0.79||||0.7|2-Sided|95.0|-0.81|2.41|||ANOVA|||After the treatment|
1615304|NCT02462291|2965231|Superiority or Other||Mean Difference (Final Values)|1.39||||0.11|2-Sided|95.0|-0.16|2.95|||ANOVA|||Baseline|
1615305|NCT02462291|2965232|Superiority or Other||Mean Difference (Final Values)|0.18||||0.84|2-Sided|95.0|-1.64|2.0|||ANOVA|||PRE Vs POST|
1615306|NCT02462291|2965232|Superiority or Other||Mean Difference (Final Values)|-2.14||||0.01|2-Sided|95.0|-3.94|-0.34|||ANOVA|||PRE Vs POST|
1615307|NCT02462291|2965232|Superiority or Other||Mean Difference (Final Values)|2.69|||<|0.01|2-Sided|95.0|0.84|4.53|||ANOVA|||After the treatment|
1615308|NCT02462291|2965232|Superiority or Other||Mean Difference (Final Values)|0.36|||<|0.83|2-Sided|95.0|-1.41|2.14|||ANOVA|||Baseline|
1615309|NCT02462291|2965233|Superiority or Other||Mean Difference (Final Values)|1.03||||0.9|2-Sided|95.0|-3.17|5.23|||ANOVA|||PRE Vs POST|
1615310|NCT02462291|2965233|Superiority or Other||Mean Difference (Final Values)|-2.99||||0.34|2-Sided|95.0|-7.15|1.16|||ANOVA|||PRE Vs POST|
1615311|NCT02462291|2965233|Superiority or Other||Mean Difference (Final Values)|2.62||||0.59|2-Sided|95.0|-1.6|6.9|||ANOVA|||After the treatment|
1615312|NCT02462291|2965233|Superiority or Other||Mean Difference (Final Values)|-1.37||||0.9|2-Sided|95.0|-5.48|2.73|||ANOVA|||Baseline|
1615313|NCT02462291|2965234|Superiority or Other||Mean Difference (Final Values)|-0.78||||0.89|2-Sided|95.0|-3.73|2.16|||ANOVA|||PRE Vs POST|
1615314|NCT02462291|2965234|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.88|2-Sided|95.0|-3.14|2.69|||ANOVA|||PRE Vs POST|
1615315|NCT02462291|2965234|Superiority or Other||Mean Difference (Final Values)|-1.31|||=|0|2-Sided|95.0|-4.3|1.7|||ANOVA|||After the treatment|
1615316|NCT02462291|2965234|Superiority or Other||Mean Difference (Final Values)|-0.74|||=|0|2-Sided|95.0|-3.6|2.1|||ANOVA|||Baseline|
1615317|NCT02462291|2965235|Superiority or Other||Mean Difference (Final Values)|-0.84|||<|0.01|2-Sided|95.0|-1.52|-0.17|||ANOVA|||PRE Vs POST|
1615318|NCT02462291|2965235|Superiority or Other||Mean Difference (Final Values)|0.94|||<|0.01|2-Sided|95.0|0.28|1.61|||ANOVA|||PRE Vs POST|
1615319|NCT02462291|2965235|Superiority or Other||Mean Difference (Final Values)|-1.94|||<|0.01|2-Sided|95.0|-2.6|-1.2|||ANOVA|||After the treatment|
1615320|NCT02462291|2965235|Superiority or Other||Mean Difference (Final Values)|-0.14|||<|1|2-Sided|95.0|-0.8|0.5|||ANOVA|||Baseline|
1615321|NCT02462291|2965236|Superiority or Other||Mean Difference (Final Values)|3.1||||1|2-Sided|95.0|-3.7|9.9|||ANOVA|||PRE Vs POST|
1615322|NCT02462291|2965236|Superiority or Other||Mean Difference (Final Values)|-31.5|||<|0.01|2-Sided|95.0|-38.2|-24.8|||ANOVA|||PRE Vs POST|
1615323|NCT02462291|2965236|Superiority or Other||Mean Difference (Final Values)|33.3|||<|0.01|2-Sided|95.0|26.4|40.2|||ANOVA|||After the treatment|
1615324|NCT02462291|2965236|Superiority or Other||Mean Difference (Final Values)|-1.27|||<|1|2-Sided|95.0|-7.9|5.4|||ANOVA|||Baseline|
1615325|NCT02462057|2965244|Equivalence|The anticipated sample size of 3500 provided 80% power to detect a 3% pairwise difference between the proportions of participants who enrolled in HF with significance testing conducted at the Bonferroni-corrected significance level of 0.005 (0.05/10) to account for the 10 pairwise between-arm comparisons and pessimistically allowing for up to 10% further exclusions. The baseline monthly enrolment rate was estimated at ∼1%/month.|||||<|0.0001|||||||Fisher Exact||||
1615326|NCT02461589|2965277|Other||Treatment difference|-1.86|||<|0.0001|2-Sided|95.0|-2.12|-1.6|||Mixed Models Analysis||||
1615327|NCT02461589|2965277|Other||Treatment difference|-1.69|||<|0.0001|2-Sided|95.0|-1.95|-1.42|||Mixed Models Analysis||||
1615328|NCT02461589|2965277|Other||Treatment difference|-1.34|||<|0.0001|2-Sided|95.0|-1.61|-1.08|||Mixed Models Analysis||||
1615329|NCT02461589|2965277|Other||Treatment difference|-1.04|||<|0.0001|2-Sided|95.0|-1.3|-0.77|||Mixed Models Analysis||||
1615330|NCT02460978|2965351|Superiority||Odds Ratio (OR)|3.07|Standard Error of the Mean|0.2054|<|0.0001|2-Sided|95.0|2.05|4.6|||Regression, Logistic|Adjusted for baseline HbA1c and randomization strata||Odds Ratio vs. Placebo|
1615331|NCT02460978|2965351|Superiority||Odds Ratio (OR)|2.71|Standard Error of the Mean|0.2058|<|0.0001|2-Sided|95.0|1.81|4.06|||Regression, Logistic|Adjusted for baseline HbA1c and randomization strata||Odds Ratio vs. Placebo|
1615332|NCT02460978|2965352|Superiority||Mean Difference (Final Values)|10.7|Standard Error of the Mean|1.0396|<|0.0001|2-Sided|95.0|8.66|12.74|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week*treatment, and week*baseline.||Difference vs. placebo in adjusted mean change from baseline|
1615333|NCT02460978|2965352|Superiority||Mean Difference (Final Values)|9.02|Standard Error of the Mean|1.0415|<|0.0001|2-Sided|95.0|6.97|11.06|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week*treatment, and week*baseline.||Difference vs. placebo in adjusted mean change from baseline|
1615334|NCT02460978|2965353|Superiority||Mean Difference (Final Values)|-9.36|Standard Error of the Mean|2.4487||0.0001|2-Sided|95.0|-14.16|-4.55|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week*treatment, and week*baseline.||Difference vs. placebo in adjusted mean change from baseline|
1615466|NCT02453256|2965851|Superiority|||||||0.0015||||||P-value from Van Elteren analysis stratified by IL-6 level (<10; >=10 pg/mL) at screening.|Van Elteren||||
1615335|NCT02460978|2965353|Superiority||Mean Difference (Final Values)|-9.85|Standard Error of the Mean|2.4519|<|0.0001|2-Sided|95.0|-14.66|-5.03|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week*treatment, and week*baseline.||Difference vs. placebo in adjusted mean change from baseline|
1615336|NCT02460978|2965354|Superiority||Mean Difference (Final Values)|-19.74|Standard Error of the Mean|2.3419|<|0.0001|2-Sided|95.0|-24.34|-15.14|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week*treatment, and week*baseline.||Difference vs. placebo in adjusted mean change from baseline|
1615337|NCT02460978|2965354|Superiority||Mean Difference (Final Values)|-15.66|Standard Error of the Mean|2.3468|<|0.0001|2-Sided|95.0|-20.26|-11.05|||Mixed Models Analysis|Adjusted for baseline, treatment, week, randomization stratum, week*treatment, and week*baseline.||Difference vs. placebo in adjusted mean change from baseline|
1615338|NCT02460978|2965355|Superiority||Mean Difference (Final Values)|-3.74|Standard Error of the Mean|0.3812|<|0.0001|2-Sided|95.0|-4.49|-2.99|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week*treatment, and week*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline|
1615339|NCT02460978|2965355|Superiority||Mean Difference (Final Values)|-3.21|Standard Error of the Mean|0.3829|<|0.0001|2-Sided|95.0|-3.96|-2.45|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week*treatment, and week*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline|
1615340|NCT02460978|2965356|Superiority||Mean Difference (Final Values)|-11.08|Standard Error of the Mean|1.5331|<|0.0001|2-Sided|95.0|-14.04|-8.02|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week*treatment, and week*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline|
1615341|NCT02460978|2965356|Superiority||Mean Difference (Final Values)|-10.78|Standard Error of the Mean|1.5291|<|0.0001|2-Sided|95.0|-13.73|-7.72|||Mixed Models Analysis|Adjusted for ln(baseline), treatment, week, randomization stratum, week*treatment, week*ln(baseline).||Difference vs. placebo in adjusted mean percentage change from baseline|
1615342|NCT02460978|2965357|Superiority||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.0578|<|0.0001|2-Sided|95.0|-0.53|-0.3|||Mixed Models Analysis|Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week*treatment, and week*baseline HbA1c.||Difference vs. placebo in adjusted mean change from baseline|
1615343|NCT02460978|2965357|Superiority||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.0579|<|0.0001|2-Sided|95.0|-0.49|-0.26|||Mixed Models Analysis|Model is adjusted for baseline HbA1c, treatment, week, randomization stratum, week*treatment, and week*baseline HbA1c.||Difference vs. placebo in adjusted mean change from baseline|
1615344|NCT02460562|2965366|Superiority||Odds Ratio (OR)|0.45|||<|0.05|2-Sided|95.0|||||Chi-squared|||Caries assessments were performed to examine the difference in mean number of surface caries (DMFS) ± standard deviation between the control and the intervention groups at baseline and at 1.5 years.The transition (∆Q) of developed new caries surfaces (ICDAS score 1-3) from baseline to 1.5 years of follow-up for the two groups was analyzed with respect to arrest or progress rates. Numbers of new caries surfaces were compared by independent t-test, Pearson chi-square and correlation coefficient.|
1615345|NCT02460562|2965367|Superiority||||||<|0.05||||||Mean salivary fluoride concentrations (part per million) between groups were assessed at different time points using repeated measures analysis of variance. Saliva fluoride concentration from each groups were compared with baseline using a t-test.|ANOVA|||Mean saliva fluoride concentration (part per million) collected at different time points was compared in order to assess the change in capacity for fluoride release and recharge from the resin denture base and to assess differences between the control and the intervention group.|
1615346|NCT02459951|2965405|Superiority|||||||0.002||||||"refer to cylinder E (2.5 diameter)"|Regression, Logistic||||
1615347|NCT02459951|2965405|Superiority|||||||0.004||||||"refer to cylinder D (2 diameter)"|Regression, Logistic||||
1615348|NCT02459951|2965405|Superiority|||||||0.022||||||"refer to cylinder C (1.5 diameter)"|Regression, Logistic||||
1615349|NCT02459951|2965405|Superiority|||||||0.465|||||||Regression, Logistic|"refer to cylinder B(1 diameter)"|||
1615350|NCT02459951|2965405|Superiority|||||||0.059||||||"refer to cylinder A (.5 diameter)"|Regression, Logistic||||
1615351|NCT02459899|2965411|Superiority||Least squares mean difference|-0.38|Standard Error of the Mean|0.136||0.006|2-Sided|95.0|-0.65|-0.11||Threshold for significance < 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.|
1615352|NCT02459899|2965411|Superiority||Least squares mean difference|-0.48|Standard Error of the Mean|0.135|<|0.001|2-Sided|95.0|-0.75|-0.22||Threshold for significance < 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.|
1615353|NCT02459899|2965411|Superiority||Least squares mean difference|-0.25|Standard Error of the Mean|0.139|<|0.07|2-Sided|95.0|-0.53|0.02||Threshold for significance < 0.05|MMRM|||Analysis was performed using MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline A1C-by-time interaction as a covariate.|
1615354|NCT02459418|2965418|Other||Median Difference (Net)|2.14|||||2-Sided|90.0|-9.91|12.29||||||Non-transformed Tmax was tested using the non-parametric Wilcoxon signed rank test to assess the differences between Gonal-f® RFF and AFOLIA. Median difference and corresponding 90% CIs were was calculated using an Exact Hodges-Lehmann estimate with an exact confidence interval.|
1615355|NCT02459418|2965419|Equivalence|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected Cmax were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|177.17|||||2-Sided|90.0|125.65|249.81||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.|
1615467|NCT02453256|2965852|Superiority||Weighted difference|-5.41||||0.3276|2-Sided|95.0|-16.2|5.4|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 60% improvement in mRSS.|
1615356|NCT02459418|2965420|Equivalence|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-last) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|163.0|||||2-Sided|90.0|94.0|282.67||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.|
1615357|NCT02459418|2965422|Other||Median Difference (Net)|7.5|||||2-Sided|90.0|4.5|11.5||||||Non-transformed Tmax was tested using the non-parametric Wilcoxon signed rank test to assess the differences between Gonal-f® RFF and AFOLIA. Median differences and corresponding 90% CIs were calculated using an exact Hodges-Lehmann estimate.|
1615358|NCT02459418|2965423|Equivalence|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-∞) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS mean ratio|133.68|||||2-Sided|90.0|102.42|174.49||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.|
1615359|NCT02459418|2965424|Equivalence|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected Cmax were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|123.15|||||2-Sided|90.0|108.12|140.28||||||An ANOVA model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. LS means and 90% CIs for treatment differences on log-scale were obtained and back-transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.|
1615360|NCT02459418|2965425|Equivalence|The 90% CIs of the ratios of geometric means of log-transformed baseline corrected AUC(0-last) were used to assess bioequivalence between Gonal-f® RFF and AFOLIA using the bioequivalence interval of 80.00% to 125.00%.|Geometric LS Mean Ratio|164.96|||||2-Sided|90.0|137.82|197.45||||||A mixed-effects analysis of variance (ANOVA) model with sequence, treatment and period as fixed effects, and subject nested within sequence as random effect was used. Least squares (LS) means and 90% confidence intervals (CIs) for treatment differences on log-scale were obtained and back transformed to provide geometric LS mean ratios of AFOLIA over Gonal-f® RFF.|
1615361|NCT02459093|2965436|Superiority||Risk Ratio (RR)|0.6||||0.05|2-Sided|95.0|0.36|1.01|||Chi-squared||||
1615362|NCT02459093|2965437|Superiority||Risk Ratio (RR)|0.61||||0.04|2-Sided|95.0|0.37|0.99|||Chi-squared||||
1615363|NCT02458469|2965445|Superiority|||||||0.749|||||||ANOVA||||
1615364|NCT02458469|2965446|Superiority|||||||0.231|||||||Student-Newman-Keuls Method||||
1615365|NCT02458469|2965446|Superiority|||||||0.015|||||||Student-Newman-Keuls Method||||
1615366|NCT02458469|2965446|Superiority|||||||0.019|||||||ANOVA||||
1615367|NCT02458365|2965447|Superiority or Other||Odds Ratio (OR)|0.47||||0.003|2-Sided|95.0|0.29|0.77|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.|||
1615368|NCT02458365|2965447|Superiority or Other||Odds Ratio (OR)|0.43|||<|0.0001|2-Sided|95.0|0.29|0.64|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design|||
1615369|NCT02458365|2965448|Superiority or Other||Odds Ratio (OR)|0.5||||0.005|2-Sided|95.0|0.31|0.81|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.|||
1615370|NCT02458365|2965448|Superiority or Other||Odds Ratio (OR)|0.53||||0.002|2-Sided|95.0|0.35|0.78|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design|||
1615371|NCT02458365|2965449|Superiority or Other||Odds Ratio (OR)|0.54||||0.004|2-Sided|95.0|0.35|0.82|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.|||
1615372|NCT02458365|2965449|Superiority or Other||Odds Ratio (OR)|0.53|||<|0.001|2-Sided|95.0|0.37|0.76|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design|||
1615373|NCT02458365|2965450|Superiority or Other||Odds Ratio (OR)|0.6||||0.013|2-Sided|95.0|0.4|0.9|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.|||
1615374|NCT02458365|2965450|Superiority or Other||Odds Ratio (OR)|0.55||||0.001|2-Sided|95.0|0.38|0.78|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design|||
1615375|NCT02458365|2965451|Superiority or Other||Odds Ratio (OR)|0.44|||<|0.0001|2-Sided|95.0|0.35|0.54|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.|||
1615376|NCT02458365|2965451|Superiority or Other||Odds Ratio (OR)|0.5|||<|0.0001|2-Sided|95.0|0.41|0.62|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design|||
1615377|NCT02458365|2965452|Superiority or Other||Odds Ratio (OR)|0.45|||<|0.0001|2-Sided|95.0|0.36|0.56|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.|||
1615378|NCT02458365|2965452|Superiority or Other||Odds Ratio (OR)|0.53|||<|0.0001|2-Sided|95.0|0.43|0.67|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design|||
1615379|NCT02458365|2965453|Superiority or Other||Odds Ratio (OR)|0.61|||<|0.0001|2-Sided|95.0|0.5|0.75|||Regression, Logistic|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.|||
1615380|NCT02458365|2965453|Superiority or Other||Odds Ratio (OR)|0.7|||<|0.001|2-Sided|95.0|0.57|0.84|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design|||
1615468|NCT02453256|2965852|Superiority||Weighted difference|4.32||||0.5139|2-Sided|95.0|-8.7|17.3|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 40% improvement in mRSS.|
1615381|NCT02458365|2965454|Superiority or Other||Odds Ratio (OR)|0.55|||<|0.0001|2-Sided|95.0|0.45|0.68|||Regression, Linear|Adjusted model that controls for potential confounds and covariates, including variables that predicted non-response and the primary outcomes.|||
1615382|NCT02458365|2965454|Superiority or Other||Odds Ratio (OR)|0.62|||<|0.0001|2-Sided|95.0|0.51|0.75|||Regression, Logistic|Hierarchical logistic regression using random intercepts for school to account for the clustered study design|||
1615383|NCT02458287|2965461|Superiority or Other||LS Mean Difference|-37.2|Standard Error of the Mean|3.99|<|0.001|2-Sided|95.0|-45.0|-29.3|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group * visit interaction, baseline value, baseline value * visit interaction as covariates.|
1615384|NCT02458287|2965461|Superiority or Other||LS Mean Difference|-56.2|Standard Error of the Mean|3.84|<|0.001|2-Sided|95.0|-63.7|-48.6|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group * visit interaction, baseline value, baseline value * visit interaction as covariates.|
1615385|NCT02458287|2965462|Superiority or Other||LS Mean Difference|-35.8|Standard Error of the Mean|4.38|<|0.001|2-Sided|95.0|-44.4|-27.1|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group * visit interaction, baseline value, baseline value * visit interaction as covariates.|
1615386|NCT02458287|2965462|Superiority or Other||LS Mean Difference|-57.9|Standard Error of the Mean|4.25|<|0.001|2-Sided|95.0|-66.2|-49.5|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group * visit interaction, baseline value, baseline value * visit interaction as covariates.|
1615387|NCT02458287|2965463|Superiority or Other||LS Mean Difference|-26.7|Standard Error of the Mean|2.96|<|0.001|2-Sided|95.0|-32.5|-20.8|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group * visit interaction, baseline value, baseline value * visit interaction as covariates.|
1615388|NCT02458287|2965463|Superiority or Other||LS Mean Difference|-39.7|Standard Error of the Mean|2.86|<|0.001|2-Sided|95.0|-45.4|-34.1|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group * visit interaction, baseline value, baseline value * visit interaction as covariates.|
1615389|NCT02458287|2965464|Superiority or Other||LS Mean Difference|-43.0|Standard Error of the Mean|4.53|<|0.001|2-Sided|95.0|-51.9|-34.0|||MMRM|||LS-mean differences and associated 95% confidence intervals, and p-values are from an MMRM model with fixed effects for treatment groups, visit, treatment group * visit interaction, baseline value, baseline value * visit interaction as covariates.|
1615390|NCT02458287|2965473|Superiority or Other||LS Mean Difference|-63.4|Standard Error of the Mean|4.4|<|0.001|2-Sided|95.0|-72.0|-54.7|||Mixed Models Repeated Measures (MMRM)|||LS-mean difference, associated 95% confidence intervals, and p-value are from MMRM model with fixed effects for treatment groups, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction as covariates.|
1615391|NCT02457546|2965524|Non-Inferiority|"The statistical hypothesis for testing the treatment difference was presented as follows:~H0: Δ ≤ -0.10 tested against the alternative hypothesis Ha: Δ > -0.10. where:~Δ is the difference between the success rates of Experimental (Evicel®) and Control (DuraSeal™) (Experimental minus Control)~-0.10 is the non-inferiority difference PC is the proportion of success in DuraSeal™ Control subjects and PE is the proportion of success in EVICEL® subjects."|Difference in Success Rates|6.3|||||2-Sided|95.0|-1.8|14.4|||||||
1615392|NCT02456740|2965550|Superiority|If the erenumab 140 mg group for both remaining MPFID secondary endpoints were statistically significant, then the erenumab 70 mg group for the two remaining MPFID secondary endpoints was tested for significance using the Hochberg method with the same alpha level carried over from 140 mg group.|LS Mean Difference|-2.22|||<|0.001|2-Sided|95.0|-3.28|-1.16|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.|
1615393|NCT02456740|2965550|Superiority|If the first tier secondary endpoints were statistically significant for both erenumab doses the erenumab 140 mg group for the 2 remaining MPFID secondary endpoints was tested using the Hochberg method at a level of 0.05; If only the erenumab 70 mg group or 140 mg group showed statistical significance for the first tier secondary endpoints then the erenumab 140 group for the 2 remaining MPFID secondary endpoints was tested for significance at a level of either 0.04 or 0.01 respectively.|LS Mean Difference|-2.57|||<|0.001|2-Sided|95.0|-3.62|-1.51|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.|
1615394|NCT02456740|2965551|Superiority|If the erenumab 140 mg group for both remaining MPFID secondary endpoints were statistically significant, then the erenumab 70 mg group for the two remaining MPFID secondary endpoints was tested for significance using the Hochberg method with the same alpha level carried over from 140 mg group.|LS Mean Difference|-1.86|||<|0.001|2-Sided|95.0|-2.95|-0.77|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.|
1615395|NCT02456740|2965551|Superiority|If the first tier secondary endpoints were statistically significant for both erenumab doses the erenumab 140 mg group for the 2 remaining MPFID secondary endpoints was tested using the Hochberg method at a level of 0.05; If only the erenumab 70 mg group or 140 mg group showed statistical significance for the first tier secondary endpoints then the erenumab 140 group for the 2 remaining MPFID secondary endpoints was tested for significance at a level of either 0.04 or 0.01 respectively.|LS Mean Difference|-2.43|||<|0.001|2-Sided|95.0|-3.51|-1.35|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.|
1615507|NCT02452047|2965955|Other|Difference in Category 1 ECI %|Difference in Category 1 ECI %|-12.5||||0.047|2-Sided|95.0|-36.3|-0.3|||Miettinen and Nurminen method||||
1615396|NCT02456740|2965552|Superiority|If the primary endpoint was statistically significant for the erenumab 140 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.01.|LS Mean Difference|-1.42|||<|0.001|2-Sided|95.0|-1.71|-1.12|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, (stratification factors region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.|
1615397|NCT02456740|2965552|Superiority|If the primary endpoint was statistically significant for the erenumab 70 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.04.|LS Mean Difference|-0.94|||<|0.001|2-Sided|95.0|-1.23|-0.64|||Generalized Linear Mixed Model|||Analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.|
1615398|NCT02456740|2965553|Superiority|If the primary endpoint was statistically significant for the erenumab 140 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.01.|Odds Ratio (OR)|2.81|||<|0.001|2-Sided|95.0|2.01|3.94|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test, stratified by the randomization stratification factors (region and prior/current treatment with migraine prophylactic medication).|
1615399|NCT02456740|2965553|Superiority|If the primary endpoint was statistically significant for the erenumab 70 mg group, using a gate-keeping strategy, the first two (first tier) secondary endpoints were tested using the Hochberg method at an alpha level of 0.04.|Odds Ratio (OR)|2.13|||<|0.001|2-Sided|95.0|1.52|2.98|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test, stratified by the randomization stratification factors (region and prior/current treatment with migraine prophylactic medication).|
1615400|NCT02456740|2965554|Superiority|The primary endpoint was tested independently for each erenumab dose at an alpha level of 0.04 for 70 mg and of 0.01 for 140 mg to maintain the type 1 error rate at an alpha level of 0.05.|LS Mean Difference|-1.85|||<|0.001|2-Sided|95.0|-2.33|-1.37|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.|
1615401|NCT02456740|2965554|Superiority|The primary endpoint was tested independently for each erenumab dose at an alpha level of 0.04 for 70 mg and of 0.01 for 140 mg to maintain the type 1 error rate at an alpha level of 0.05.|LS Mean Difference|-1.4|||<|0.001|2-Sided|95.0|-1.88|-0.92|||Generalized Linear Mixed Model|||The primary endpoint was analyzed using a generalized linear mixed model which includes treatment, visit, treatment by visit interaction, stratification factors (region and prior/current treatment with migraine prophylactic medication), and baseline value as covariates.|
1615402|NCT02456662|2965555|Superiority|Based on previous work as well as anecdotal data from our clinic population, we expect vomiting to occur in approximately 30% of our patients who take their doxycycline the night before their procedure. To have 80% power to detect a 50% decrease in nausea and vomiting, we will need 122 patients in each arm of the study.||||||0|||||||Chi-squared||||
1615403|NCT02455388|2965567|Other||Odds Ratio (OR)|1.7|||<|0.01|2-Sided||||||Regression, Logistic||||
1615404|NCT02455388|2965568|Superiority||||||<|0.05|||||||ANOVA||||
1615405|NCT02455388|2965569|Equivalence|No equivalence margin set.|||||<|0.001|||||||Intraclass correlation coefficient||||
1615406|NCT02454608|2965629|Superiority or Other|||||||0.7|||||||t-test, 2 sided||||
1615407|NCT02454608|2965630|Superiority or Other|||||||0.78|||||||t-test, 2 sided||||
1615408|NCT02454608|2965631|Superiority or Other|||||||0.6|||||||t-test, 2 sided||||
1615409|NCT02454608|2965632|Superiority or Other|||||||0.02|||||||t-test, 2 sided||||
1615410|NCT02454608|2965633|Superiority or Other|||||||0.25|||||||Mixed Models Analysis||||
1615411|NCT02454608|2965634|Superiority or Other|||||||0.001|||||||Mixed Models Analysis||||
1615412|NCT02454608|2965635|Superiority or Other|||||||0.01|||||||Mixed Models Analysis||||
1615413|NCT02454296|2965664|Superiority or Other|||||||0.34|||||||Wilcoxon (Mann-Whitney)||||
1615414|NCT02454296|2965665|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1615415|NCT02454296|2965666|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1615416|NCT02453711|2965731|Other||Treatment difference (%-points)|-11.55|Standard Error of the Mean|1.12|<|0.0001|2-Sided|95.0|-14.38|-8.72|||ANCOVA||Semaglutide 0.4 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett’s method was used to adjust for multiple comparisons.|
1615417|NCT02453711|2965731|Other||Treatment difference (%-points)|-8.88|Standard Error of the Mean|1.12|<|0.0001|2-Sided|95.0|-11.72|-6.03|||ANCOVA||Semaglutide 0.3 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett’s method was used to adjust for multiple comparisons.|
1615418|NCT02453711|2965731|Other||Treatment difference (%-points)|-9.31|Standard Error of the Mean|1.12|<|0.0001|2-Sided|95.0|-12.15|-6.46|||ANCOVA||Semaglutide 0.2 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett’s method was used to adjust for multiple comparisons.|
1615432|NCT02453282|2965785|Superiority||Hazard Ratio (HR)|0.78||||0.045|2-Sided|95.0|0.606|0.994||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy|
1615419|NCT02453711|2965731|Other||Treatment difference (%-points)|-6.32|Standard Error of the Mean|1.12|<|0.0001|2-Sided|95.0|-9.16|-3.49|||ANCOVA||Semaglutide 0.1 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett’s method was used to adjust for multiple comparisons.|
1615420|NCT02453711|2965731|Other||Treatment difference (%-points)|-3.7|Standard Error of the Mean|1.13|=|0|2-Sided|95.0|-6.55|-0.85|||ANCOVA||Semaglutide 0.05 mg - placebo pool|J2R-MI: Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Dunnett’s method was used to adjust for multiple comparisons.|
1615421|NCT02453685|2965735|Superiority or Other||Treatment difference at week 32|0.18||||0.0435|2-Sided|95.0|0.01|0.36|||Mixed Models Analysis||"'Treatment difference' refers to BIAsp 30 minus Basal-bolus"|Analysis was performed using mixed model repeated measurements including treatment, region, and strata as fixed effects, HbA1c at baseline as covariate, interactions between all fixed effects and visit and using an unstructured residual covariance matrix.|
1615422|NCT02453555|2965744|Superiority or Other||Adjusted Mean Difference (Net)|-1.09|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-1.34|-0.84|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in Empagliflozin 25 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 52 in All Placebo group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.|
1615423|NCT02453555|2965745|Superiority or Other||Adjusted Mean Difference (Net)|-1.21|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-1.45|-0.96|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in Empagliflozin 25 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 52 in Linagliptin 5 mg + Placebo 25 mg group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.|
1615424|NCT02453555|2965746|Superiority or Other||Adjusted Mean Difference (Net)|-1.22|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-1.45|-0.99|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 52 in All Empagliflozin group) - (adjusted mean change from baseline in HbA1c at Week 52 in All Placebo group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.|
1615425|NCT02453555|2965748|Superiority or Other||Adjusted Mean Difference (Net)|-1.14|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-1.36|-0.91|||Mixed Models Analysis||Adjusted Mean Difference was calculated as: (adjusted mean change from baseline in HbA1c at Week 24 in Empagliflozin 10 mg/linagliptin 5 mg group) - (adjusted mean change from baseline in HbA1c at Week 24 in Linagliptin 5 mg + Placebo 10 mg group)|A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD] formula), prior use of antidiabetic drug, treatment, visit, visit by Treatment interaction as fixed effect(s). The covariance used to fit the model was unstructured.|
1615426|NCT02453321|2965772|Superiority|||||||0.065|||||||Kruskal-Wallis||||
1615427|NCT02453321|2965773|Superiority|||||||0.355|||||||Kruskal-Wallis||||
1615428|NCT02453282|2965783|Superiority||Hazard Ratio (HR)|0.88||||0.103|2-Sided|95.0|0.746|1.027||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy|
1615429|NCT02453282|2965783|Superiority||Hazard Ratio (HR)|0.97||||0.663|2-Sided|95.0|0.824|1.131||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy|
1615430|NCT02453282|2965784|Superiority||Hazard Ratio (HR)|0.94||||0.534|2-Sided|95.0|0.787|1.132||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy|
1615431|NCT02453282|2965784|Superiority||Hazard Ratio (HR)|0.9||||0.255|2-Sided|95.0|0.746|1.08||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy|
1615464|NCT02453256|2965849|Superiority||Difference in least square means|-0.053||||0.4489|2-Sided|95.0|-0.192|0.085|||Repeated Measure||||
1615465|NCT02453256|2965850|Superiority||Difference in least square means|0.167||||0.0001|2-Sided|95.0|0.083|0.25|||Repeated Measure||||
1615433|NCT02453282|2965785|Superiority||Hazard Ratio (HR)|0.76||||0.03|2-Sided|95.0|0.597|0.975||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy|
1615434|NCT02453282|2965792|Superiority||Odds Ratio (OR)|1.16||||0.406|2-Sided|95.0|0.818|1.647||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous) and PD-L1 status (>=25% Vs <25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy|
1615435|NCT02453282|2965792|Superiority||Odds Ratio (OR)|0.76||||0.093|2-Sided|95.0|0.543|1.048||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous) and PD-L1 status (>=25% Vs <25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy|
1615436|NCT02453282|2965792|Superiority||Odds Ratio (OR)|0.65||||0.012|2-Sided|95.0|0.462|0.908||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (>=25% Vs <25%), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy|
1615437|NCT02453282|2965793|Superiority||Odds Ratio (OR)|0.97||||0.887|2-Sided|95.0|0.661|1.43||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (>=25% Vs <25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy|
1615438|NCT02453282|2965793|Superiority||Odds Ratio (OR)|0.67||||0.029|2-Sided|95.0|0.464|0.959||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (>=25% Vs <25%), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy|
1615439|NCT02453282|2965793|Superiority||Odds Ratio (OR)|0.69||||0.05|2-Sided|95.0|0.48|1.0||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non squamous) and PD-L1 status (>=25% Vs <25%), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy|
1615440|NCT02453282|2965794|Superiority||Odds Ratio (OR)|0.95||||0.82|2-Sided|95.0|0.601|1.496||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy|
1615441|NCT02453282|2965794|Superiority||Odds Ratio (OR)|0.87||||0.534|2-Sided|95.0|0.549|1.363||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab + Tremelimumab Vs SoC Chemotherapy|
1615442|NCT02453282|2965794|Superiority||Odds Ratio (OR)|0.91||||0.698|2-Sided|95.0|0.582|1.437||P-value is based on twice the change in log-likelihood resulting from the addition of a treatment factor to the model.|Regression, Logistic||The analysis was performed using logistic regression adjusting for histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.|Durvalumab Monotherapy Vs SoC Chemotherapy|
1615443|NCT02453282|2965795|Superiority||Hazard Ratio (HR)|1.0||||0.984|2-Sided|95.0|0.845|1.179||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy|
1615444|NCT02453282|2965795|Superiority||Hazard Ratio (HR)|1.25||||0.01|2-Sided|95.0|1.054|1.485||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy|
1615445|NCT02453282|2965795|Superiority||Hazard Ratio (HR)|1.24||||0.015|2-Sided|95.0|1.043|1.475||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy|
1615446|NCT02453282|2965796|Superiority||Hazard Ratio (HR)|1.16||||0.138|2-Sided|95.0|0.954|1.403||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy|
1615447|NCT02453282|2965796|Superiority||Hazard Ratio (HR)|1.38||||0.001|2-Sided|95.0|1.136|1.678||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy|
1615545|NCT02451839|2966009|Superiority||||||<|0.001|||||||paired t-test||||
1615448|NCT02453282|2965796|Superiority||Hazard Ratio (HR)|1.09||||0.383|2-Sided|95.0|0.894|1.339||The analysis was performed using stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy|
1615449|NCT02453282|2965797|Superiority||Hazard Ratio (HR)|1.18||||0.207|2-Sided|95.0|0.911|1.541||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy|
1615450|NCT02453282|2965797|Superiority||Hazard Ratio (HR)|0.87||||0.324|2-Sided|95.0|0.667|1.143||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy|
1615451|NCT02453282|2965798|Superiority||Hazard Ratio (HR)|0.98||||0.802|2-Sided|95.0|0.828|1.157||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy|
1615452|NCT02453282|2965798|Superiority||Hazard Ratio (HR)|0.94||||0.43|2-Sided|95.0|0.794|1.103||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy|
1615453|NCT02453282|2965798|Superiority||Hazard Ratio (HR)|0.96||||0.602|2-Sided|95.0|0.812|1.128||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy|
1615454|NCT02453282|2965799|Superiority||Hazard Ratio (HR)|1.13||||0.218|2-Sided|95.0|0.931|1.371||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy|
1615455|NCT02453282|2965799|Superiority||Hazard Ratio (HR)|1.01||||0.952|2-Sided|95.0|0.834|1.213||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy|
1615456|NCT02453282|2965799|Superiority||Hazard Ratio (HR)|0.88||||0.194|2-Sided|95.0|0.725|1.067||The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (>=25% Vs <25%) and histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy|
1615457|NCT02453282|2965800|Superiority||Hazard Ratio (HR)|1.09||||0.523|2-Sided|95.0|0.836|1.421||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs Durvalumab Monotherapy|
1615458|NCT02453282|2965801|Superiority||Hazard Ratio (HR)|1.05||||0.705|2-Sided|99.5|0.722|1.534||The analysis was performed using stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy|
1615459|NCT02453282|2965802|Superiority||Hazard Ratio (HR)|0.85||||0.202|2-Sided|98.77|0.611|1.173||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab + Tremelimumab Vs SoC Chemotherapy|
1615460|NCT02453282|2965802|Superiority||Hazard Ratio (HR)|0.76||||0.036|2-Sided|97.54|0.564|1.019||The 2-sided p-value was calculated using a stratified log-rank test adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Log Rank||The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Breslow approach.|Durvalumab Monotherapy Vs SoC Chemotherapy|
1615461|NCT02453256|2965846|Superiority||Hazard Ratio (HR)|0.63||||0.0821|2-Sided|95.0|0.37|1.06|||Cox-proportional hazards model||||
1615462|NCT02453256|2965847|Superiority||Difference in least square means|-2.46||||0.4378|2-Sided|95.0|-8.72|3.79|||Repeated Measure||||
1615463|NCT02453256|2965848|Superiority||Difference in least square means|-2.44||||0.4339|2-Sided|95.0|-8.57|3.7|||Repeated Measure||||
1615469|NCT02453256|2965852|Superiority||Weighted difference|21.91||||0.0007|2-Sided|95.0|9.2|34.6|||Cochran-Mantel-Haenszel|||This statistical analysis applies to participants with ≥ 20% improvement in mRSS.|
1615470|NCT02453256|2965853|Superiority||Difference in least square means|-1.73||||0.0983|2-Sided|95.0|-3.78|0.32|||Repeated Measure|||Difference in least square means between the TCZ group and the Placebo group at week 48. Null hypothesis: There is no difference between the TCZ group and the placebo group in mean change in mRSS from baseline to Week 48.|
1615471|NCT02452892|2965879|Superiority|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.3907||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, & gender as factors & baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed & the negative score for affected subjects & visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."|
1615472|NCT02452892|2965879|Superiority|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0307||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, & gender as factors & baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed & the negative score for affected subjects & visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."|
1615473|NCT02452892|2965880|Superiority|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.593||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where Incorrect Item #2 data was removed.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, & gender as factors & baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed & the negative score for affected subjects & visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."|
1615474|NCT02452892|2965880|Superiority|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0848||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was removed.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, & gender as factors & baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed & the negative score for affected subjects & visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."|
1615475|NCT02452892|2965881|Superiority|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.3537||||||"P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.~."|ANCOVA|P-value estimated using ANCOVA model with treatment, age, & gender as factors & baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed & the negative score for affected subjects & visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."|
1615476|NCT02452892|2965881|Superiority|Negative score is sum of 10 items: 2,4,6,7,8,11,13,15,18,20.||||||0.0307||||||P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.|ANCOVA|P-value estimated using ANCOVA model with treatment, age, & gender as factors & baseline negative PANAS score as a covariate.||"Due to item #2 error, analyses were done in the following manner to check robustness:~All missing values including these 72 data points in item #2 were considered as random missing data (values posted in outcome measures).~The 72 data points were removed & the negative score for affected subjects & visits were not calculated.~The 72 data points were imputed using worst value imputation algorithm (using score =5 as extremely) while other random missing values imputed by average."|
1615477|NCT02452892|2965882|Superiority|Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.||||||0.166||||||P-value not adjusted for multiple comparisons.|ANCOVA|P-value estimated using ANCOVA model with treatment,age,& gender as factors & baseline positive PANAS score as a covariate.|||
1615478|NCT02452892|2965882|Superiority|Positive score is the sum of 10 items: 1,3,5,9,10,12,14,16,17,19.||||||0.2672||||||P-value not adjusted for multiple comparisons.|ANCOVA|P-value estimated using ANCOVA model with treatment,age,& gender as factors & baseline positive PANAS score as a covariate.|||
1615479|NCT02452892|2965883|Superiority|||||||0.7509||||||The p-value is not adjusted for multiple comparisons.|ANCOVA|P-value was estimated using ANCOVA model with treatment, age, & gender as factors and baseline negative MADRS score as a covariate.||Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.|
1615480|NCT02452892|2965883|Superiority|||||||0.0932||||||P-value is not adjusted for multiple comparisons.|ANCOVA|P-value was estimated using ANCOVA model with treatment, age, & gender as factors and baseline negative MADRS score as a covariate.||Estimates for LS Means, confidence intervals, difference in LS means and p-value are from an ANCOVA model with treatment, age, sex as factors and baseline negative MADRS score as a covariate.|
1615508|NCT02452047|2965956|Other|Difference in percentages|Difference blood creatinine inc %|-25.0|||||2-Sided|95.0|-49.8|-10.1|||||Miettinen & Nurminen method||
1615481|NCT02452892|2965884|Superiority|The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.||||||0.232||||||For 20min. LFMS, P-value not adjusted for multiple comparisons. P-value estimated using Logistic Regression model including Wk2 baseline HAM-D6 total score, treatment, age & gender as covariates.|Regression, Logistic|Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response|||
1615482|NCT02452892|2965884|Superiority|The persistence rate calculated based on Week 1 treatment group: 20 minutes LFMS, 60 minutes LFMS and sham therapy.||||||0.294||||||For 60 min LFMS, P-value not adjusted for multiple comparisons. P-value estimated using LR model including Wk2 baseline HAM-D6 total score, treatment, age & gender as covariates.|Regression, Logistic|Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response|||
1615483|NCT02452892|2965885|Superiority|||||||0.966||||||P-value is not adjusted for multiple comparisons. P-value was estimated from Mixed Model Repeated Measures (MMRM) model.|Mixed Models Analysis|Week 2 baseline HAM-D6 total score, treatment, visit, treatment*visit, age, & gender included in model. Visit was the repeated measure within subject.|||
1615484|NCT02452892|2965886|Superiority|To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.||||||0.859||||||P-value displayed for 20min. Mixed Model Repeated Measures (MMRM) model.|Mixed Models Analysis|Week 1 baseline HAM-D6 total score, treatment,visit treatment*visit age, & gender included in model. Visit was the repeated measure within subjects.||Comparisons of 20 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS & sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.|
1615485|NCT02452892|2965886|Superiority|To control for multiple comparisons in the primary endpoint analysis, a hierarchical approach was taken. First LFMS 60min. was compared to LFMS sham. If p<0.05 for this comparison, then LFMS 20min. was formally compared to LFMS sham for statistical significance.||||||0.307||||||"P-value displayed for 60min.~Mixed Model Repeated Measures (MMRM) model."|Mixed Models Analysis|Week 1 baseline HAM-D6 total score, treatment,visit treatment*visit age, & gender included in model. Visit was the repeated measure within subjects.||Comparisons of 60 min LFMS vs. sham, LSMean diff with 95% Confidence Interval (CI) reported. Hypothesis 1: no difference between 60 min. LFMS and sham therapy in mean change from baseline (Day 1) to end of Tx Day 4 in HAM-D6 total score. If hypothesis is rejected at significance level of 0.05, then second hypothesis will be tested. Hypothesis 2:no difference between 20 min. LFMS & sham therapy in mean change from baseline (Day 1) to the end of Tx. Day 4 in HAM-D6 total score.|
1615486|NCT02452463|2965906|Superiority|||||||1|||||||Cochran-Mantel-Haenszel||||
1615487|NCT02452463|2965907|Superiority|||||||0.203|||||||paired T-test|||Evaluating change relative to baseline.|
1615488|NCT02452463|2965907|Superiority|||||||0.183|||||||Paired T-test|||Comparing change relative to baseline.|
1615489|NCT02452463|2965907|Superiority|||||||0.616|||||||t-test, 2 sided||||
1615490|NCT02452463|2965908|Superiority|||||||0.073|||||||t-test, 2 sided||||
1615491|NCT02452463|2965909|Superiority|||||||0.131|||||||t-test, 2 sided||||
1615492|NCT02452463|2965910|Superiority|||||||0.25|||||||Log Rank|||Null Hypotheses: PFS distributions are equal|
1615493|NCT02452463|2965911|Superiority|||||||0.75|||||||Log Rank|||Null Hypotheses: OS distributions are equal|
1615494|NCT02452463|2965913|Superiority|||||||0.107|||||||Cochran-Mantel-Haenszel||||
1615495|NCT02452320|2965921|Other|||||||0.59|||||||t-test, 2 sided||||
1615496|NCT02452190|2965931|Superiority|A fixed-sequence multiple testing procedure was implemented to test the primary and secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p>0.05, no further comparisons were interpreted inferentially.|CAE rate ratio (reslizumab vs placebo)|0.79||||0.194|2-Sided|95.0|0.562|1.124||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group, randomization stratification factors, and number of prior exacerbations as model factors and the logarithm of treatment duration excluding the summed duration of exacerbations in the treatment period as an offset variable.|
1615497|NCT02452047|2965946|Other|Difference in percentages|Difference in FMR %|-27.3|||||2-Sided|90.0|-52.8|12.8|||||Miettinen & Nurminen method||
1615498|NCT02452047|2965947|Other|Difference in percentages|Difference in FMR %|0.0|||||2-Sided|90.0|-20.8|36.6|||||Miettinen & Nurminen method||
1615499|NCT02452047|2965948|Other|Difference in percentages|Difference in FMR %|0.0|||||2-Sided|90.0|-20.8|36.6|||||Miettinen & Nurminen method||
1615500|NCT02452047|2965949|Other|Adjusted difference in EFU FCR %|Difference in EFU FCR %|24.7|||||2-Sided|90.0|3.8|51.4|||||Miettinen and Nurminen method stratified by infection-site stratum||
1615501|NCT02452047|2965950|Other|Adjusted difference in EOT FCR %|Adjusted difference in EOT FCR %|25.4|||||2-Sided|90.0|3.1|53.6|||||Miettinen and Nurminen method stratified by infection-site stratum||
1615502|NCT02452047|2965951|Other|Adjusted difference in OTX FCR %|Adjusted difference in OTX FCR %|33.9|||||2-Sided|90.0|7.4|61.1|||||Miettinen and Nurminen method stratified by infection-site stratum||
1615503|NCT02452047|2965952|Other|Difference in mortality %|Difference in mortality %|-17.3|||||2-Sided|90.0|-46.4|6.7|||||Miettinen and Nurminen method stratified by infection-site stratum||
1615504|NCT02452047|2965953|Other|Difference in Day 28 FCR %|Difference in Day 28 FCR %|26.3|||||2-Sided|90.0|1.3|51.5|||||Miettinen and Nurminen method stratified by infection-site stratum||
1615505|NCT02452047|2965954|Other|Difference in percentages|Difference in nephrotoxicity %|-45.9||||0.002||95.0|-69.1|-18.4|||Fisher Exact||Miettinen & Nurminen method||
1615506|NCT02452047|2965955|Other|Difference in Category 2 ECI %|Difference in Category 2 ECI %|-12.5||||0.047||95.0|-36.3|-0.3|||Miettinen and Nurminen method||||
1615537|NCT02451839|2966001|Superiority|||||||0.006|||||||paired t-test||||
1615509|NCT02452047|2965956|Other|Difference in percentages|Difference in pyrexia %|0.4|||||2-Sided|95.0|-25.2|19.7|||||Miettinen & Nurminen method||
1615510|NCT02452047|2965957|Other|Difference in percentages|Difference in drug-related discon %|-12.5|||||2-Sided|95.0|-36.3|-0.3|||||Miettinen & Nurminen method||
1615511|NCT02452047|2965958|Other|Difference in percentages|Difference in discontinuation %|-18.8|||||2-Sided|95.0|-43.3|-6.2|||||Miettinen & Nurminen method||
1615512|NCT02452047|2965959|Other|Difference in percentages|Difference in drug-related SAE %|0.0|||||2-Sided|95.0|-19.7|11.2|||||Miettinen & Nurminen method||
1615513|NCT02452047|2965960|Other|Difference in percentages|Difference in drug-related AE %|-15.1|||||2-Sided|95.0|-42.3|9.2|||||Miettinen & Nurminen method||
1615514|NCT02452047|2965961|Other|Difference in percentages|Difference in SAE %|-21.6|||||2-Sided|95.0|-47.8|1.3|||||Miettinen & Nurminen method||
1615515|NCT02452047|2965962|Other|Difference in percentages|Difference in AE %|-10.3|||||2-Sided|95.0|-33.1|18.0|||||Miettinen & Nurminen method||
1615516|NCT02452047|2965963|Other|Difference in percentages|Difference in FOR %|-7.3|||||2-Sided|90.0|-27.5|21.4|||||Stratified Miettinen & Nurminen method by infection type||
1615517|NCT02451943|2965976|Superiority||Hazard Ratio (HR)|1.123||||0.3347|2-Sided|95.0|0.892|1.413|||Log Rank|Stratified|||
1615518|NCT02451943|2965977|Superiority||Hazard Ratio (HR)|0.616||||0.0934|2-Sided|95.0|0.347|1.093|||Log Rank|Stratified|||
1615519|NCT02451943|2965983|Superiority||Hazard Ratio (HR)|1.231||||0.0422|2-Sided|95.0|1.009|1.502|||Log Rank|Stratified|||
1615520|NCT02451943|2965984|Superiority||Hazard Ratio (HR)|0.951||||0.7618|2-Sided|95.0|0.69|1.312|||Log Rank|Stratified|||
1615521|NCT02451943|2965985|Superiority||Hazard Ratio (HR)|1.047||||0.6945|2-Sided|95.0|0.841|1.303|||Log Rank|Stratified|||
1615522|NCT02451917|2965986|Non-Inferiority or Equivalence|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.994|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.|
1615523|NCT02451917|2965987|Non-Inferiority or Equivalence|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.999|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.|
1615524|NCT02451917|2965988|Non-Inferiority or Equivalence|A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.999|||||||ANOVA|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18r andomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.|
1615525|NCT02451917|2965989|Non-Inferiority or Equivalence|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.||||||0.668|||||||ANOVA|||A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.|
1615526|NCT02451917|2965990|Non-Inferiority or Equivalence|t-test was applied to compare percentages of the time spent in hypoglycemia, hyperglycemia and euglycemia on CGM readings.|||||<|0.05|||||||t-test, 1 sided|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.|
1615527|NCT02451917|2965991|Non-Inferiority or Equivalence|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.|number of nocturnal events per patient|0.0||||0.047|2-Sided|||||Analysis of covariance (ANOVA) model - number of nocturnal hypoglycemic events per patient during 24 weeks|ANOVA||The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%.|
1615528|NCT02451917|2965991|Non-Inferiority or Equivalence|A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov–Smirnov statistics) was performed at baseline for each sequence of the therapy.|number of total events per patient|0.0||||0.35|2-Sided|||||Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks|ANOVA||The calculated value for the estimation parameter was zero, since the best treatment option for those with diabetes is reach a good glycemic control without hypoglycemia.|Analysis of covariance (ANOVA) model - total hypoglycemic events per patient during 24 weeks|
1615529|NCT02451917|2965992|Non-Inferiority or Equivalence|A sample size of 34 participants (16randomized to sequence IGlar/INPH and 18randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint(A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%.||||||0.00045||||||The intention-to-treat population consisted of all randomized participants.|ANOVA|||A sample size of 34 participants (16 randomized to sequence IGlar/INPH and 18 randomized to sequence INPH/IGlar) provided 90% power to detect a mean difference of 0.7% in the primary endpoint (A1c), considering a 15% dropout rate and assuming an SD of 0.85%, and a type I error of 5%. Test for data normality (Kolmogorov–Smirnov statistics) was performed at baseline for each sequence of the therapy.|
1615530|NCT02451839|2965994|Superiority||||||<|0.001|||||||paired t-test||||
1615531|NCT02451839|2965995|Superiority||||||<|0.001|||||||paired t-test||||
1615532|NCT02451839|2965996|Superiority||||||<|0.001|||||||paired t-test||||
1615533|NCT02451839|2965997|Superiority||||||<|0.001|||||||paired t-test||||
1615534|NCT02451839|2965998|Superiority|||||||0.006|||||||paired t-test||||
1615535|NCT02451839|2965999|Superiority||||||<|0.001|||||||paired t-test||||
1615536|NCT02451839|2966000|Superiority||||||<|0.001|||||||paired t-test||||
1615546|NCT02451137|2966053|Superiority||Odds Ratio (OR)|1.19||||0.0308|2-Sided|95.4|1.01|1.39||Threshold for significance at 0.046 level.|Regression, Logistic|||A logistic regression model was used with treatment arm as a fixed effect and adjusted for: randomization strata of HbA1c target (<8%,<7%), sulfonylurea (SU) use (yes/no), glucagon like peptide1-receptor agonists (GLP-1 RA) use (yes/no) and baseline HbA1c (as continuous).|
1615547|NCT02450539|2966081|Superiority||Median Difference (Final Values)|-0.04|Standard Error of the Mean|0.03|||2-Sided|||||||||EQ-5D-5L Index Value|
1615548|NCT02450539|2966082|Superiority||Mean Difference (Final Values)|-3.13|Standard Error of the Mean|2.07|||2-Sided|||||||||EQ VAS Overall Self-rated Health Score|
1615549|NCT02450539|2966083|Superiority||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.22|||2-Sided|||||||||Rash|
1615550|NCT02450539|2966083|Superiority||Mean Difference (Final Values)|0.69|Standard Error of the Mean|0.28|||2-Sided|||||||||Mean core plus lung worst 5 symptoms severity|
1615551|NCT02450539|2966083|Superiority||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.19|||2-Sided|||||||||Mean brain tumor symptom severity|
1615552|NCT02450539|2966083|Superiority||Mean Difference (Final Values)|0.52|Standard Error of the Mean|0.21|||2-Sided|||||||||Mean core plus lung cancer symptom severity|
1615553|NCT02450539|2966083|Superiority||Mean Difference (Final Values)|0.39|Standard Error of the Mean|0.19|||2-Sided|||||||||Mean lung cancer symptom severity|
1615554|NCT02450539|2966083|Superiority||Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.34|||2-Sided|||||||||Mean interference|
1615555|NCT02450539|2966083|Superiority||Mean Difference (Final Values)|0.53|Standard Error of the Mean|0.22|||2-Sided|||||||||Mean core symptom severity|
1615556|NCT02450539|2966083|Superiority||Mean Difference (Final Values)|0.86|Standard Error of the Mean|0.29|||2-Sided|||||||||Diarrhea|
1615557|NCT02450539|2966083|Superiority||Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.23|||2-Sided|||||||||Headache|
1615558|NCT02450539|2966084|Superiority||Hazard Ratio (HR)|1.184||||0.7039|2-Sided|95.0|0.502|2.792|||Stratified Log Rank||Stratified Cox regression model.|Stratification factors are baseline ECOG performance status (0 vs 1), Number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (<=9 months vs >9 months).|
1615559|NCT02450539|2966085|Superiority||Rate Difference|-13.2|||||2-Sided|95.0|-29.2|2.8|||||Confidence intervals are based on the normal approximation to the binomial.||
1615560|NCT02450539|2966086|Superiority||Rate Difference|-17.9|||||2-Sided|95.0|-29.3|-6.6|||||Confidence intervals are based on the normal approximation to the binomial.||
1615561|NCT02450539|2966090|Superiority||Hazard Ratio (HR)|1.765||||0.0068|2-Sided|95.0|1.165|2.672|||Stratified log-rank test.||Stratified Cox proportional hazard model|Stratified by baseline ECOG performance status (0 vs 1), number of Prior Therapies (received only platinum-based therapy vs Received platinum-based Therapy plus Immune Checkpoint Inhibitor), and time since initiation of first line therapy (<=9 months vs >9 months).|
1615562|NCT02450526|2966105|Superiority|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|83.7|||<|0.0001|2-Sided|95.0|78.7|88.7|||Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.|
1615563|NCT02450526|2966106|Superiority|The comparison between mean scores of SGA at Treatment Cycle 1, Day 29 is based on 2 separate linear mixed models, adjusting on the two stratification parameters, gender and baseline ILA severity score, and the centre.|Treatment Difference|2.603|||<|0.0001|2-Sided|95.0|2.327|2.878||The test was two-sided at the significance level of 0.05|Mixed Models Analysis|||Superiority analysis of Dysport® to placebo was tested using a linear mixed model.|
1615564|NCT02450526|2966107|Superiority|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|73.8|||<|0.0001|2-Sided|95.0|59.1|88.4|||Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.|
1615565|NCT02450526|2966108|Non-Inferiority|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment Difference|-2.4|||||2-Sided|95.0|-6.7|1.9||||||The non-inferiority of Dysport® to Botox on the ILA at maximum frown was tested using a multivariate logistic regression model|
1615566|NCT02450526|2966109|Superiority|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|87.5|||<|0.0001|2-Sided|95.0|82.5|92.4||The test is two-sided at the significance level of 0.025.|Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.|
1615567|NCT02450526|2966110|Superiority|The model includes treatment group, stratification factors, gender and baseline severity score of glabellar lines at maximum frown measured by the ILA, and centre as explanatory variables and responder (Yes or No) as response variable.|Treatment difference|94.3|||<|0.0001|2-Sided|95.0|90.8|97.7||The test is two-sided at the significance level of 0.025.|Regression, Logistic|||Superiority analysis of Dysport® to placebo was tested using a multivariate logistic regression model.|
1615568|NCT02449915|2966115|Other|||||||0.52|||||||Wilcoxon (Mann-Whitney)||||
1615569|NCT02449902|2966116|Superiority or Other|||||||0.0401|||||||ANCOVA||||
1615570|NCT02449902|2966117|Superiority or Other|||||||0.182|||||||ANCOVA||||
1615571|NCT02449902|2966118|Superiority or Other|||||||0.0001|||||||ANCOVA||||
1615572|NCT02449902|2966119|Superiority or Other|||||||0.1945|||||||ANCOVA||||
1615573|NCT02449902|2966120|Superiority or Other|||||||0.1429|||||||Fisher Exact||||
1615574|NCT02449902|2966121|Superiority or Other|||||||0.9951|||||||ANOVA||||
1615575|NCT02449902|2966122|Superiority or Other|||||||0.0002|||||||ANCOVA||||
1615576|NCT02449902|2966123|Superiority or Other|||||||0.0017|||||||ANCOVA||||
1615577|NCT02449902|2966124|Superiority or Other|||||||0.0002|||||||ANOVA||||
1615578|NCT02449902|2966125|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1615579|NCT02449889|2966130|Non-Inferiority|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.5|||||2-Sided|95.0|-0.5|1.4|||||ANOVA with treatment, stratum (<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG SC versus rhCG SC.|
1615580|NCT02449889|2966130|Non-Inferiority|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.3|||||2-Sided|95.0|-0.6|1.3|||||ANOVA with treatment, stratum (<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of fertilized (2 pronuclei (2PN)) oocytes for the treatment comparison of HP-hCG IM versus rhCG SC|
1615581|NCT02449889|2966131|Non-Inferiority|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.6|||||2-Sided|95.0|-0.4|1.6|||||ANOVA with treatment, stratum (<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of Mll oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC|
1615582|NCT02449889|2966131|Non-Inferiority|Pre-specified supportive endpoint analyzed in a similar manner as the primary endpoint.|Mean Difference (Final Values)|0.4|||||2-Sided|95.0|-0.6|1.5|||||ANOVA with treatment, stratum (<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Number of MII oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC|
1615583|NCT02449889|2966132|Non-Inferiority|As step 2 in the pre-specified sequential testing, NI was tested for HP-hCG SC compared to rhCG SC.|Mean Difference (Final Values)|0.8|||||2-Sided|95.0|-0.5|2.0|||||ANOVA with treatment, stratum (<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Mean number of oocytes retrieved for the treatment comparison of HP-hCG SC versus rhCG SC|
1615584|NCT02449889|2966132|Non-Inferiority|Treatment comparisons were done in a sequential manner. First non-inferiority (NI) was tested for HP-hCG IM compared to rhCG SC (lower limit of the 95% confidence interval (CI) > -3.0). If NI was demonstrated, NI was also to be tested for HP-hCG SC compared to rhCG SC.|Mean Difference (Final Values)|0.6|||||2-Sided|95.0|-0.6|1.8|||||ANOVA with treatment, stratum (<10 or ≥10 follicles with a diameter ≥12 mm), and site as fixed factors.|Mean number of oocytes retrieved for the treatment comparison of HP-hCG IM versus rhCG SC|
1615585|NCT02449473|2966142|Superiority|The repeated measures analysis included treatment group, baseline log-transformed sputum free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|0.49||||0.1126|2-Sided|95.0|0.2|1.2|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in sputum free ECP concentration; Tralo 300 mg Q2W vs placebo.|
1615586|NCT02449473|2966143|Superiority|The repeated measures analysis included treatment group, baseline log-transformed blood free ECP and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|1.11||||0.3769|2-Sided|95.0|0.88|1.4|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in blood free ECP concentration; Tralo 300 mg Q2W vs placebo.|
1615587|NCT02449473|2966144|Superiority|The repeated measures analysis included treatment group, baseline log-transformed differential sputum eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A REML approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|0.57||||0.6334|2-Sided|95.0|0.06|6.0|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in differential sputum eosinophils; Tralo 300 mg Q2W vs placebo.|
1615588|NCT02449473|2966145|Superiority|The repeated measures analysis included treatment group, baseline log-transformed eosinophils and visit as fixed effects. Treatment-by-visit interaction was also included. The analysis was performed using log-transformed data. A restricted maximum likelihood (REML) approach was used. An unstructured variance-covariance matrix was used to model the within-subject errors.|LS geometric mean ratio|1.21||||0.0546|2-Sided|95.0|1.0|1.48|||Repeated measures analysis|||Comparison of change from baseline, expressed as a ratio, in blood eosinophil count; Tralo 300 mg Q2W vs placebo.|
1615589|NCT02449473|2966146|Superiority|The model included treatment group as fixed effect and baseline log-transformed airway submucosal eosinophils as a continuous covariate. No interaction terms were included in the model. The analysis was performed using log-transformed data. All group comparisons from analysis of covariance (ANCOVA) model were based on Type III sums of squares.|Least square (LS) geometric mean ratio|1.43||||0.3862|2-Sided|95.0|0.63|3.27|||ANCOVA|||Comparison of change from baseline, expressed as a ratio, in airway submucosal eosinophils; Tralo 300 mg Q2W vs placebo. The null hypothesis was that the change in airway submucosal eosinophils at Week 12 on tralokinumab was equal to the corresponding change on placebo.|
1615590|NCT02449356|2966151|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1615591|NCT02449356|2966152|Superiority or Other||Odds Ratio (OR)|0.73|||<|0.05|2-Sided|95.0|||||Chi-squared||||
1615592|NCT02449291|2966153|Superiority|||||||0.029|||||||Wilcoxon (Mann-Whitney)||||
1615593|NCT02449291|2966153|Superiority|||||||0.06|||||||Wilcoxon (Mann-Whitney)||||
1615594|NCT02449291|2966154|Superiority|||||||0.166|||||||Wilcoxon (Mann-Whitney)||||
1615595|NCT02449291|2966154|Superiority|||||||0.103|||||||Wilcoxon (Mann-Whitney)||||
1615596|NCT02449291|2966155|Superiority|||||||0.505|||||||Chi-squared||||
1615597|NCT02449291|2966155|Superiority|||||||0.474|||||||Chi-squared||||
1615598|NCT02449291|2966156|Superiority|||||||0.222|||||||Chi-squared||||
1615599|NCT02449291|2966156|Superiority|||||||0.115|||||||Chi-squared||||
1615600|NCT02449291|2966157|Superiority|||||||0.009|||||||Chi-squared||||
1615601|NCT02449291|2966157|Superiority|||||||0.009|||||||Chi-squared||||
1615602|NCT02449291|2966158|Superiority|||||||0.44|||||||Chi-squared||||
1615603|NCT02449291|2966158|Superiority|||||||0.209|||||||Chi-squared||||
1615604|NCT02449291|2966159|Superiority||||||<|0.001|||||||Regression, Cox||||
1615605|NCT02449291|2966159|Superiority||||||<|0.003|||||||Regression, Cox||||
1615606|NCT02449291|2966160|Superiority|||||||0.552||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared||||
1615607|NCT02449291|2966160|Superiority|||||||0.17||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared||||
1615608|NCT02449291|2966161|Superiority|||||||0.002||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared||||
1615609|NCT02449291|2966161|Superiority|||||||0.009||||||One-sided p-value. No adjustment for multiple comparisons. A priori threshold for statistical significance = 0.025.|Chi-squared||||
1615610|NCT02449291|2966162|Superiority|||||||0.016||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.015) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson’s χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.|
1615611|NCT02449291|2966162|Superiority|||||||0.016||||||One-sided p-value. After adjustment for multiplicity using Hommel's method. (Note: unadjusted p value = 0.016) A priori threshold for statistical significance = 0.025.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson’s χ2 test. The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.|
1615612|NCT02449174|2966163|Superiority|||||||0.2059|||||||Chi-squared, Corrected||||
1615613|NCT02449174|2966164|Superiority|||||||0.8958|||||||Chi-squared, Corrected||||
1615614|NCT02449044|2966166|Superiority or Other|||||||0.3609||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214|
1615615|NCT02449044|2966166|Superiority or Other|||||||0.4401||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190|
1615616|NCT02449044|2966166|Superiority or Other|||||||0.9292||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178|
1615617|NCT02449044|2966166|Superiority or Other|||||||0.6923||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166|
1615618|NCT02449044|2966166|Superiority or Other|||||||0.6691||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142|
1615619|NCT02449044|2966166|Superiority or Other|||||||0.0013||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106|
1615620|NCT02449044|2966166|Superiority or Other|||||||0.0119||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94|
1615621|NCT02449044|2966166|Superiority or Other|||||||0.0164||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82|
1615622|NCT02449044|2966166|Superiority or Other|||||||0.0128||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70|
1615623|NCT02449044|2966166|Superiority or Other|||||||0.0277||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58|
1615624|NCT02449044|2966166|Superiority or Other|||||||0.0631||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50|
1615625|NCT02449044|2966166|Superiority or Other|||||||0.0325||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42|
1615626|NCT02449044|2966166|Superiority or Other|||||||0.0039||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34|
1615627|NCT02449044|2966166|Superiority or Other|||||||0.1871||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26|
1615628|NCT02449044|2966166|Superiority or Other|||||||0.0224||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18|
1615629|NCT02449044|2966166|Superiority or Other|||||||0.686||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10|
1615630|NCT02449044|2966166|Superiority or Other|||||||0.2715||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31|
1615631|NCT02449044|2966166|Superiority or Other|||||||0.2575||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student t-test|||Statistical analysis at Day 14|
1615632|NCT02449044|2966167|Superiority or Other|||||||0.3334||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214|
1615633|NCT02449044|2966167|Superiority or Other|||||||0.3739||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190|
1615634|NCT02449044|2966167|Superiority or Other|||||||0.1001||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178|
1615635|NCT02449044|2966167|Superiority or Other|||||||0.6233||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166|
1615636|NCT02449044|2966167|Superiority or Other|||||||0.4448||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142|
1615637|NCT02449044|2966167|Superiority or Other|||||||0.0412||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106|
1615674|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 178.|Student's t-test||||
1615638|NCT02449044|2966167|Superiority or Other|||||||0.0702||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94|
1615639|NCT02449044|2966167|Superiority or Other|||||||0.2749||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82|
1615640|NCT02449044|2966167|Superiority or Other|||||||0.2269||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70|
1615641|NCT02449044|2966167|Superiority or Other|||||||0.3109||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58|
1615642|NCT02449044|2966167|Superiority or Other|||||||0.1926||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50|
1615643|NCT02449044|2966167|Superiority or Other|||||||0.2198||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42|
1615644|NCT02449044|2966167|Superiority or Other|||||||0.7787||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34|
1615645|NCT02449044|2966167|Superiority or Other|||||||0.321||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26|
1615646|NCT02449044|2966167|Superiority or Other|||||||0.634||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18|
1615647|NCT02449044|2966167|Superiority or Other|||||||0.6902||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10|
1615648|NCT02449044|2966167|Superiority or Other|||||||0.6095||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31|
1615649|NCT02449044|2966167|Superiority or Other|||||||0.1739||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student t-test|||Statistical analysis at Day 14|
1615650|NCT02449044|2966168|Superiority or Other|||||||0.0944||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 214|
1615651|NCT02449044|2966168|Superiority or Other|||||||0.0269||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 202|
1615652|NCT02449044|2966168|Superiority or Other|||||||0.3101||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 190|
1615653|NCT02449044|2966168|Superiority or Other|||||||0.36||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 178|
1615654|NCT02449044|2966168|Superiority or Other|||||||0.3743||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 166|
1615655|NCT02449044|2966168|Superiority or Other|||||||0.282||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 154|
1615656|NCT02449044|2966168|Superiority or Other|||||||0.1598||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 142|
1615657|NCT02449044|2966168|Superiority or Other|||||||0.2488||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 130|
1615658|NCT02449044|2966168|Superiority or Other|||||||0.3476||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 118|
1615659|NCT02449044|2966168|Superiority or Other|||||||0.5237||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 106|
1615660|NCT02449044|2966168|Superiority or Other|||||||0.1346||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 94|
1615661|NCT02449044|2966168|Superiority or Other|||||||0.2335||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 82|
1615662|NCT02449044|2966168|Superiority or Other|||||||0.1923||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 70|
1615663|NCT02449044|2966168|Superiority or Other|||||||0.0852||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 58|
1615664|NCT02449044|2966168|Superiority or Other|||||||0.354||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 50|
1615665|NCT02449044|2966168|Superiority or Other|||||||0.7175||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 42|
1615666|NCT02449044|2966168|Superiority or Other|||||||0.5138||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 34|
1615667|NCT02449044|2966168|Superiority or Other|||||||0.7084||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 26|
1615668|NCT02449044|2966168|Superiority or Other|||||||0.7656||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 18|
1615669|NCT02449044|2966168|Superiority or Other|||||||0.1054||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Week 10|
1615670|NCT02449044|2966168|Superiority or Other|||||||0.4922||||||Descriptive use only, no statistical adjustments for multiplicity were planned.|Student's t-test|||Statistical analysis at Day 31|
1615671|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 214.|Student's t-test||||
1615672|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 202.|Student's t-test||||
1615673|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 190.|Student's t-test||||
1616210|NCT02441179|2966896|Superiority or Other|||||||0.006|||||||Kruskal-Wallis||||
1615675|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 166.|Student's t-test||||
1615676|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 154.|Student's t-test||||
1615677|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 142.|Student's t-test||||
1615678|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 130.|Student's t-test||||
1615679|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 118.|Student's t-test||||
1615680|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 106.|Student's t-test||||
1615681|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 94.|Student's t-test||||
1615682|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 82.|Student's t-test||||
1615683|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 70.|Student's t-test||||
1615684|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 58.|Student's t-test||||
1615685|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 50.|Student's t-test||||
1615686|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 42.|Student's t-test||||
1615687|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 34.|Student's t-test||||
1615688|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 26.|Student's t-test||||
1615689|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 18.|Student's t-test||||
1615690|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Week 10.|Student's t-test||||
1615691|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Day 31.|Student's t-test||||
1615692|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Day 14.|Student's t-test||||
1615693|NCT02449044|2966175|Superiority or Other||||||<|0.0001||||||This was the p-value for analysis at Day 1.|Student's t-test||||
1615694|NCT02449018|2966193|Superiority||Mean Difference (Net)|0.28|Standard Deviation|0.31||0.13|2-Sided|90.0|-0.24|0.79|||ANCOVA||||
1615695|NCT02448914|2966199|Non-Inferiority or Equivalence|Analysis was first to attempt to show non-inferiority. To show non-inferiority of TRIGEL over Duodopa, the lower limit of the two-sided CI for the treatment ratio had to be above the chosen non-inferiority margin of 0.9. If non-inferiority was shown, analysis continued with test of superiority. To show superiority of TRIGEL versus Duodopa, the lower confidence limit had to be above 1 (corresponding to a p-value less than 0.05).|back-transformed ratio|1.382|||<|0.0001|2-Sided|95.0|1.264|1.511|||ANCOVA|||Levodopa AUC 0-14h/dose, was derived using the trapezoidal method and divided by the total administered dose of levodopa during the corresponding time interval.The primary endpoint was log transformed and analysed using an ANCOVA, adjusting for treatment, period and patient. The back-transformed ratio of TRIGEL over Duodopa was calculated together with 95% confidence intervals (CI) and the associated (2 sided) p value.|
1615696|NCT02448810|2966217|Other||Hazard Ratio (HR)|0.8||||0.354|2-Sided|70.0|0.5|1.4||P-value is based on a one-sided log-rank test.|Log Rank||||Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).
1615697|NCT02448810|2966217|Other||Hazard Ratio (HR)|0.8||||0.246|2-Sided|70.0|0.5|1.1||P-value is based on a one-sided log-rank test.|Log Rank||||Hazard Ratio and 70% CI are based on a Cox proportional hazards model with a covariate for treatment (imalumab vs SoC).
1615698|NCT02448641|2966237|Other||Mean Difference (Net)|0.58||||0.5347|2-Sided|95.0|-1.26|2.43|||Regression, Logistic||The LSM difference (SE) from the sham surgery group was 0.58 (0.934), with a 95% CI of (-1.26, 2.43), an effect size of 0.11, and a p-value of 0.5347.|Statistical Analysis: NeuroQOL score for Lower Extremity Function (Between-group Effect size is calculated as the lease square [LS] mean difference)|
1615699|NCT02448641|2966237|Other||Mean Difference (Net)|-0.36||||0.7788|2-Sided|95.0|-2.9|2.17|||Regression, Logistic||The LSM difference (SE) from the sham surgery group was -0.36 (1.283), with a 95% CI of (-2.90, 2.17), an effect size of 0.05, and a p-value of 0.7788.|Statistical analysis: NeuroQOL score for the Upper Extremity Function (Between-group Effect size is calculated as the lease square [LS] mean difference)|
1615700|NCT02448641|2966241|Other||Mean Difference (Final Values)|1.2||||0.2959|2-Sided|95.0|-1.1|3.6|||Regression, Logistic||The LSM difference (SE) from the sham surgery group was 1.2 (1.18), with a 95% CI of (-1.1, 3.6), an effect size of 0.19, and a p-value of 0.2959|Between-group Effect size is calculated as the lease square [LS] mean difference|
1615701|NCT02448368|2966257|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|113.0|||||2-Sided|90.0|93.3|137.0|||||||
1615702|NCT02448368|2966257|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|103.0|||||2-Sided|90.0|94.6|113.0|||||||
1615703|NCT02448368|2966257|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|107.0|||||2-Sided|90.0|98.1|116.0|||||||
1615704|NCT02448368|2966258|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170|Geometric Least Squares mean Ratio|115.0|||||2-Sided|90.0|95.3|140.0|||||||
1615705|NCT02448368|2966258|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|104.0|||||2-Sided|90.0|95.0|113.0|||||||
1616107|NCT02444715|2966674|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1615706|NCT02448368|2966258|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|107.0|||||2-Sided|90.0|98.3|116.0|||||||
1615707|NCT02448368|2966259|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|116.0|||||2-Sided|90.0|94.8|143.0|||||||
1615708|NCT02448368|2966259|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|99.9|||||2-Sided|90.0|85.5|117.0|||||||
1615709|NCT02448368|2966259|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|99.4|||||2-Sided|90.0|88.3|112.0|||||||
1615710|NCT02448368|2966261|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|131.0|||||2-Sided|90.0|116.0|147.0|||||||
1615711|NCT02448368|2966261|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|159.0|||||2-Sided|90.0|135.0|188.0|||||||
1615712|NCT02448368|2966261|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|161.0|||||2-Sided|90.0|139.0|187.0|||||||
1615713|NCT02448368|2966262|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|129.0|||||2-Sided|90.0|114.0|146.0|||||||
1615714|NCT02448368|2966262|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|170.0|||||2-Sided|90.0|146.0|199.0|||||||
1615715|NCT02448368|2966262|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|170.0|||||2-Sided|90.0|147.0|195.0|||||||
1615716|NCT02448368|2966264|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|106.0|||||2-Sided|90.0|91.5|124.0|||||||
1615717|NCT02448368|2966264|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio|181.0|||||2-Sided|90.0|164.0|200.0|||||||
1615718|NCT02448368|2966264|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the Pharmacokinetics (PK), Pharmacodynamics (PD), and safety profile of RDEA3170.|Geometric Least Squares Mean Ratio|232.0|||||2-Sided|90.0|202.0|266.0|||||||
1615719|NCT02448043|2966269|Superiority|||||||0.062||||||Threshold is p<0.05|t-test, 2 sided|||Comparison between baseline nail brittleness values and completion values|
1615720|NCT02448043|2966270|Superiority|||||||0.912||||||Threshold is p<0.05|t-test, 2 sided|||Comparing baseline values of both arms to completion values of both arms|
1615721|NCT02448043|2966271|Superiority|||||||0.523||||||Threshold is p<0.05|t-test, 2 sided||||
1615722|NCT02448043|2966272|Superiority|||||||0.532||||||Threshold is p<0.05|t-test, 2 sided||||
1615723|NCT02447432|2966363|Non-Inferiority|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.28|||||2-Sided|95.0|0.92|1.8||||||(Synflorix/10Pn_4d) antibody GMCs ratio for ANTI-23F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn_4d) should be below a limit of 2-fold for each of the 10 serotypes.|
1615724|NCT02447432|2966363|Non-Inferiority|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.99|||||2-Sided|95.0|0.78|1.25||||||(Synflorix/10Pn_4d) antibody GMCs ratio for ANTI-19F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn_4d) should be below a limit of 2-fold for each of the 10 serotypes.|
1615725|NCT02447432|2966363|Non-Inferiority|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.08|||||2-Sided|95.0|0.86|1.37||||||(Synflorix/10Pn_4d) antibody GMCs ratio for ANTI-18C serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn_4d) should be below a limit of 2-fold for each of the 10 serotypes.|
1615726|NCT02447432|2966363|Non-Inferiority|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.98|||||2-Sided|95.0|0.73|1.31||||||(Synflorix/10Pn_4d) antibody GMCs ratio for ANTI-14 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn_4d) should be below a limit of 2-fold for each of the 10 serotypes.|
1616108|NCT02444715|2966674|Superiority or Other|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1615727|NCT02447432|2966363|Non-Inferiority|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.88|||||2-Sided|95.0|0.69|1.13||||||(Synflorix/10Pn_4d) antibody GMCs ratio for ANTI-9V serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn_4d) should be below a limit of 2-fold for each of the 10 serotypes.|
1615728|NCT02447432|2966363|Non-Inferiority|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.05|||||2-Sided|95.0|0.88|1.25||||||(Synflorix/10Pn_4d) antibody GMCs ratio for ANTI-7F serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn_4d) should be below a limit of 2-fold for each of the 10 serotypes.|
1615729|NCT02447432|2966363|Non-Inferiority|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.12|||||2-Sided|95.0|0.78|1.61||||||(Synflorix/10Pn_4d) antibody GMCs ratio for ANTI-6B serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn_4d) should be below a limit of 2-fold for each of the 10 serotypes.|
1615730|NCT02447432|2966363|Non-Inferiority|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.03|||||2-Sided|95.0|0.85|1.26||||||(Synflorix/10Pn_4d) antibody GMCs ratio for ANTI-5 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn_4d) should be below a limit of 2-fold for each of the 10 serotypes.|
1615731|NCT02447432|2966363|Non-Inferiority|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|0.92|||||2-Sided|95.0|0.75|1.12||||||(Synflorix/10Pn_4d) antibody GMCs ratio for ANTI-4 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn_4d) should be below a limit of 2-fold for each of the 10 serotypes.|
1615732|NCT02447432|2966363|Non-Inferiority|GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance.|GMCs ratio|1.09|||||2-Sided|95.0|0.89|1.33||||||(Synflorix/10Pn_4d) antibody GMCs ratio for ANTI-1 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn_4d) should be below a limit of 2-fold for each of the 10 serotypes.|
1615733|NCT02447250|2966365|Other|||||||0.5|||||||Fisher Exact||||
1615734|NCT02447250|2966366|Other|||||||1|||||||Chi-squared||||
1615735|NCT02447250|2966368|Other|||||||1|||||||Fisher Exact||||
1615736|NCT02447250|2966369|Other|||||||0.16|||||||Chi-squared||||
1615737|NCT02447250|2966370|Other|||||||0.14|||||||Chi-squared|||comparison of mean birth weights between responders and non-responders|
1615738|NCT02446990|2966392|Superiority or Other (legacy)||Cox Proportional Hazard|0.97||||0.5285|2-Sided|95.0|0.87|1.07|||Regression, Cox||||
1615739|NCT02446990|2966393|Superiority or Other (legacy)||Cox Proportional Hazard|1.05||||0.3671|2-Sided|95.0|0.94|1.18|||Regression, Cox||||
1615740|NCT02446990|2966394|Superiority or Other (legacy)||Cox Proportional Hazard|1.06||||0.2222|2-Sided|95.0|0.96|1.18|||Regression, Cox||||
1615741|NCT02446990|2966395|Superiority or Other (legacy)||Cox Proportional Hazard|0.98||||0.6963|2-Sided|95.0|0.89|1.08|||Regression, Cox||||
1615742|NCT02446990|2966396|Superiority or Other (legacy)||Cox Proportional Hazard|0.97||||0.5916|2-Sided|95.0|0.88|1.08|||Regression, Cox||||
1615743|NCT02446990|2966397|Superiority or Other (legacy)||Cox Proportional Hazard|1.06||||0.4299|2-Sided|95.0|0.92|1.22|||Regression, Cox||||
1615744|NCT02446990|2966398|Superiority or Other (legacy)||Cox Proportional Hazard|1.0||||0.979|2-Sided|95.0|0.89|1.12|||Regression, Cox||||
1615745|NCT02446990|2966399|Superiority or Other (legacy)||Cox Proportional Hazard|0.89||||0.1458|2-Sided|95.0|0.75|1.04|||Regression, Cox||||
1615746|NCT02446990|2966400|Superiority or Other (legacy)||Cox Proportional Hazard|1.04|Standard Error of the Mean|0.08||0.6024|2-Sided|95.0|0.9|1.21|||Regression, Cox||||
1615747|NCT02446990|2966401|Superiority or Other (legacy)||Cox Proportional Hazard|1.35|Standard Error of the Mean|0.29||0.1647|2-Sided|95.0|0.88|2.05|||Regression, Cox||||
1615748|NCT02446990|2966402|Superiority or Other (legacy)||Cox Proportional Hazard|1.06|Standard Error of the Mean|0.09||0.5162|2-Sided|95.0|0.89|1.26|||Regression, Cox||||
1615749|NCT02446990|2966403|Superiority or Other (legacy)||Cox Proportional Hazard|1.1|Standard Error of the Mean|0.09||0.2493|2-Sided|95.0|0.94|1.28|||Regression, Cox||||
1615750|NCT02446990|2966404|Superiority or Other (legacy)||Cox Proportional Hazard|1.06|Standard Error of the Mean|0.07||0.3461|2-Sided|95.0|0.94|1.21|||Regression, Cox||||
1615751|NCT02446990|2966405|Superiority or Other (legacy)||Cox Proportional Hazard|1.08|Standard Error of the Mean|0.06||0.1969|2-Sided|95.0|0.96|1.2|||Regression, Cox||||
1615752|NCT02446912|2966415|Superiority|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|Mean Difference (Final Values)|16.4|||||2-Sided|95.0|6.7|26.2|||||||
1615753|NCT02446912|2966416|Superiority|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|Mean Difference (Final Values)|10.1|||||2-Sided|95.0|0.6|19.7|||||||
1615754|NCT02446912|2966417|Superiority|Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening [<10 points vs >=10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]). The logarithm of the follow-up time is used as an offset variable.|Rate Ratio|0.83||||0.258|2-Sided|95.0|0.6|1.14||Nominal p-value|Negative binomial regression||||
1615755|NCT02446912|2966418|Superiority|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|Mean Difference (Final Values)|3.3||||0.515|2-Sided|95.0|-6.7|13.4||Nominal p-value|Cochran-Mantel-Haenszel||||
1615756|NCT02446912|2966419|Superiority|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|Mean Difference (Final Values)|0.6||||0.905|2-Sided|95.0|-9.4|10.6||Nominal p-value|Cochran-Mantel-Haenszel||||
1615757|NCT02446912|2966420|Superiority|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|Mean Difference (Final Values)|18.7||||0.034|2-Sided|95.0|1.4|36.0||Nominal p-value|Cochran-Mantel-Haenszel||||
1615758|NCT02446912|2966421|Superiority|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|Mean Difference (Final Values)|17.0||||0.054|2-Sided|95.0|-0.3|34.3||Nominal p-value|Cochran-Mantel-Haenszel||||
1615759|NCT02446912|2966422|Superiority|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|Mean Difference (Final Values)|16.7||||0.013|2-Sided|95.0|3.5|29.8||Nominal p-value|Cochran-Mantel-Haenszel||||
1615760|NCT02446912|2966423|Superiority|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|Mean Difference (Final Values)|8.9||||0.18|2-Sided|95.0|-4.1|21.9||Nominal p-value|Cochran-Mantel-Haenszel||||
1615761|NCT02446912|2966424|Superiority|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|Mean Difference (Final Values)|6.4||||0.261|2-Sided|95.0|-4.8|17.7||Nominal p-value|Cochran-Mantel-Haenszel||||
1615762|NCT02446912|2966425|Superiority|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|Mean Difference (Final Values)|-3.4||||0.549|2-Sided|95.0|-14.4|7.6||Nominal p-value|Cochran-Mantel-Haenszel||||
1615763|NCT02446912|2966426|Superiority||Mean Difference (Final Values)|5.5|||||2-Sided|95.0|-6.7|17.8|||||||
1615764|NCT02446912|2966426|Superiority|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|Mean Difference (Final Values)|3.9||||0.455|2-Sided|95.0|-6.3|14.1||Nominal p-value|Cochran-Mantel-Haenszel||||
1615765|NCT02446912|2966427|Superiority||Mean Difference (Final Values)|-2.6|||||2-Sided|95.0|-14.7|9.6|||||||
1615766|NCT02446912|2966427|Superiority|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|Mean Difference (Final Values)|-4.2||||0.412|2-Sided|95.0|-14.2|5.8||Nominal p-value|Cochran-Mantel-Haenszel||||
1615767|NCT02446899|2966432|Superiority||Rate Ratio|0.67||||0.0809|2-Sided|95.0|0.48|0.94||Adjusted p-value.|Negative binomial regression|||Analysed using a negative binomial regression model. The response variable in the model is the number of flares over the 52-week treatment period. The model includes covariates of treatment group, and the stratification factors (SLEDAI-2K score at screening [<10 points vs >=10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]). The logarithm of the follow-up time is used as an offset variable.|
1616063|NCT02446483|2966510|Non-Inferiority or Equivalence|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|98.71|||||2-Sided|90.0|92.54|105.28||||||Comparison of T- rabeprazole 20 mg and R- rabeprazole 20 mg for AUC0-t.|
1615768|NCT02446899|2966433|Superiority||Mean Difference (Final Values)|4.7||||0.5469|2-Sided|95.0|-10.6|20.0||Adjusted p-value|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|
1615769|NCT02446899|2966434|Superiority||Mean Difference (Final Values)|24.0||||0.0392|2-Sided|95.0|4.3|43.6||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|
1615770|NCT02446899|2966435|Superiority||Mean Difference (Final Values)|21.2||||0.0135|2-Sided|95.0|6.8|35.7||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|
1615771|NCT02446899|2966436|Superiority||Mean Difference (Final Values)|17.3||||0.0022|2-Sided|95.0|6.5|28.2||Adjusted p-value.|Cochran-Mantel-Haenszel|||The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|
1615772|NCT02446899|2966437|Superiority|The difference in estimates and associated 95% CI are weighted and are calculated using a stratified Cochran-Mantel-Haenszel (CMH) approach, with stratification factors (SLEDAI-2K score at screening [<10 points vs >= 10 points], Week 0 OCS dose [<10 mg/day vs >=10 mg/day prednisone or equivalent] and type I IFN gene signature test result at screening [high vs low]).|Mean Difference (Final Values)|16.3||||0.0013|2-Sided|95.0|6.3|26.3||Nominal p-value.|Cochran-Mantel-Haenszel||||
1615773|NCT02446743|2966452|Other|1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference|Vaccine group difference|42.0|||||2-Sided|95.0|31.0|51.9||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615774|NCT02446743|2966452|Other|7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference|Vaccine group difference|28.0|||||2-Sided|95.0|20.2|36.6||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615775|NCT02446743|2966452|Other|3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference|Vaccine group difference|3.0|||||2-Sided|95.0|-3.9|7.6||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615776|NCT02446743|2966452|Other|1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference|Vaccine group difference|37.0|||||2-Sided|95.0|25.1|47.0||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615777|NCT02446743|2966452|Other|7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference|Vaccine group difference|25.0|||||2-Sided|95.0|9.7|37.1||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615778|NCT02446743|2966452|Other|3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference|Vaccine group difference|2.0|||||2-Sided|95.0|-4.9|6.7||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615779|NCT02446743|2966452|Other|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference|vaccine group difference|39.0|||||2-Sided|95.0|31.6|46.6||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615780|NCT02446743|2966452|Other|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference|vaccine group difference|28.0|||||2-Sided|95.0|19.1|34.9||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615781|NCT02446743|2966452|Other|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference|vaccine group difference|3.0|||||2-Sided|95.0|-1.1|5.4||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615782|NCT02446743|2966452|Other|1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference|vaccine group difference|60.0|||||2-Sided|95.0|47.9|69.6||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616064|NCT02446483|2966511|Non-Inferiority or Equivalence|Bioequivalence was established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|101.32|||||2-Sided|90.0|95.81|107.15|||||||
1615783|NCT02446743|2966452|Other|7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference|Vaccine group difference|42.0|||||2-Sided|95.0|27.8|54.5||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615784|NCT02446743|2966452|Other|3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference|Vaccine group difference|0.0|||||2-Sided|95.0|-8.0|5.4||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615785|NCT02446743|2966452|Other|1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference|Vaccine group difference|46.0|||||2-Sided|95.0|33.6|57.1||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/154 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615786|NCT02446743|2966452|Other|7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference|vaccine group difference|29.0|||||2-Sided|95.0|12.1|43.0||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615787|NCT02446743|2966452|Other|3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference|vaccine group difference|0.0|||||2-Sided|95.0|-8.4|5.0||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615788|NCT02446743|2966452|Other|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference|vaccine group difference|54.0|||||2-Sided|95.0|45.2|61.1||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615789|NCT02446743|2966452|Other|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference|Vaccine group difference|36.0|||||2-Sided|95.0|25.6|45.7||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615790|NCT02446743|2966452|Other|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference|vaccine group difference|0.0|||||2-Sided|95.0|-4.7|3.4||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615791|NCT02446743|2966452|Other|1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference|vaccine group difference|24.0|||||2-Sided|95.0|13.2|34.4||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615792|NCT02446743|2966452|Other|7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference|vaccine group difference|32.0|||||2-Sided|95.0|18.2|47.0||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615793|NCT02446743|2966452|Other|3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference|vaccine group difference|-6.0|||||2-Sided|95.0|-19.2|0.9||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615794|NCT02446743|2966452|Other|1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference|vaccine group difference|42.0|||||2-Sided|95.0|31.1|53.0||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615795|NCT02446743|2966452|Other|7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference|vaccine group difference|43.0|||||2-Sided|95.0|27.7|58.6||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615796|NCT02446743|2966452|Other|3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference|vaccine group difference|2.0|||||2-Sided|95.0|-8.7|10.2||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615797|NCT02446743|2966452|Other|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference|Vaccine group difference|33.0|||||2-Sided|95.0|25.2|40.4||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615798|NCT02446743|2966452|Other|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference|vaccine group difference|37.0|||||2-Sided|95.0|27.0|48.1||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615799|NCT02446743|2966452|Other|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference|vaccine group difference|-1.0|||||2-Sided|95.0|-9.1|4.0||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615800|NCT02446743|2966452|Other|1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference|vaccine group difference|71.0|||||2-Sided|95.0|61.2|78.5||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615801|NCT02446743|2966452|Other|7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference|Vaccine group difference|60.0|||||2-Sided|95.0|45.0|71.5||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615802|NCT02446743|2966452|Other|3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10)] Difference|vaccine group difference|0.0|||||2-Sided|95.0|-8.0|4.8||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615803|NCT02446743|2966452|Other|1 month Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference|vaccine group difference|44.0|||||2-Sided|95.0|32.7|54.1||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615804|NCT02446743|2966452|Other|7 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference|vaccine group difference|44.0|||||2-Sided|95.0|28.1|58.5||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615805|NCT02446743|2966452|Other|3 Days Post Booster/Second Vaccination. Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41)] Difference|vaccine group difference|-4.0|||||2-Sided|95.0|-14.1|2.0||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615806|NCT02446743|2966452|Other|1 Month Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference|vaccine group difference|58.0|||||2-Sided|95.0|50.5|64.7||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615807|NCT02446743|2966452|Other|7 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference|vaccine group difference|53.0|||||2-Sided|95.0|42.1|62.5||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615808|NCT02446743|2966452|Other|3 Days Post Booster/Second Vaccination. Four-fold Increase (Group 3B vs. Group B_0_1) Difference|Vaccine group difference|-2.0|||||2-Sided|95.0|-7.5|1.8||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615809|NCT02446743|2966454|Other|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|1.91|||||2-Sided|95.0|1.41|2.58||||||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615810|NCT02446743|2966454|Other|Vaccine Comparison Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|Ratio of GMTs|1.88|||||2-Sided|95.0|1.37|2.59||||||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615811|NCT02446743|2966454|Other|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B_0_1(1 month after booster or 2nd dose)|Ratio of GMTs|1.9|||||2-Sided|95.0|1.52|2.36||||||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615812|NCT02446743|2966454|Other|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|2.51|||||2-Sided|95.0|1.67|3.78||||||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615813|NCT02446743|2966454|Other|Vaccine Comparison Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|Ratio of GMTs|2.65|||||2-Sided|95.0|1.89|3.73||||||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615814|NCT02446743|2966454|Other|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B_0_1(1 month after booster or 2nd dose)|Ratio of GMTs|2.58|||||2-Sided|95.0|1.98|3.36||||||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615815|NCT02446743|2966454|Other|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|6.9|||||2-Sided|95.0|4.82|9.87||||||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615816|NCT02446743|2966454|Other|Vaccine Comparison Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|Ratio of GMTs|9.58|||||2-Sided|95.0|7.17|13.0||||||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615817|NCT02446743|2966454|Other|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B_0_1(1 month after booster or 2nd dose)|Ratio of GMTs|8.18|||||2-Sided|95.0|6.51|10.0||||||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615818|NCT02446743|2966454|Other|Vaccine Comparison Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose)|Ratio of GMTs|4.46|||||2-Sided|95.0|3.38|5.88||||||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615819|NCT02446743|2966454|Other|Vaccine Comparison Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|Ratio of GMTs|2.73|||||2-Sided|95.0|2.02|3.69||||||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615820|NCT02446743|2966454|Other|Vaccine Comparison Day 31 Group 3B vs Day 61 Group B_0_1(1 month after booster or 2nd dose)|Ratio of GMTs|3.49|||||2-Sided|95.0|2.85|4.29||||||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615821|NCT02446743|2966455|Other|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|6.0|||||2-Sided|95.0|-0.47|12.6||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615822|NCT02446743|2966455|Other|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||2-Sided|95.0|-8.4|11.8||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615823|NCT02446743|2966455|Other|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||2-Sided|95.0|-19.1|9.1||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615824|NCT02446743|2966455|Other|Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|vaccine group difference|17.0|||||2-Sided|95.0|8.2|27.8||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615825|NCT02446743|2966455|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||2-Sided|95.0|-9.7|15.7||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615826|NCT02446743|2966455|Other|Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose)|vaccine group difference|-2.0|||||2-Sided|95.0|-18.0|14.1||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615827|NCT02446743|2966455|Other|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose)|vaccine group difference|11.0|||||2-Sided|95.0|5.3|16.9||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615828|NCT02446743|2966455|Other|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||2-Sided|95.0|-6.8|8.9||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615829|NCT02446743|2966455|Other|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||2-Sided|95.0|-16.0|6.0||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615830|NCT02446743|2966455|Other|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|33.0|||||2-Sided|95.0|22.0|44.1||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615831|NCT02446743|2966455|Other|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|12.0|||||2-Sided|95.0|-3.9|28.1||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615832|NCT02446743|2966455|Other|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-25.0|||||2-Sided|95.0|-40.1|-11.2||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615833|NCT02446743|2966455|Other|Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|vaccine group difference|33.0|||||2-Sided|95.0|20.5|45.3||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615834|NCT02446743|2966455|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||2-Sided|95.0|-17.1|15.9||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615835|NCT02446743|2966455|Other|Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose)|vaccine group difference|-13.0|||||2-Sided|95.0|-25.9|-3.0||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615836|NCT02446743|2966455|Other|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose)|vaccine group difference|32.0|||||2-Sided|95.0|23.2|40.2||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615837|NCT02446743|2966455|Other|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose)|vaccine group difference|4.0|||||2-Sided|95.0|-7.6|15.7||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615838|NCT02446743|2966455|Other|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose)|vaccine group difference|-20.0|||||2-Sided|95.0|-30.0|-11.1||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615839|NCT02446743|2966455|Other|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|3.0|||||2-Sided|95.0|-1.2|9.4||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615840|NCT02446743|2966455|Other|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||2-Sided|95.0|-2.5|11.0||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615841|NCT02446743|2966455|Other|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||2-Sided|95.0|-19.4|13.0||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615842|NCT02446743|2966455|Other|Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||2-Sided|95.0|-3.6|4.4||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615843|NCT02446743|2966455|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||2-Sided|95.0|-3.6|8.8||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615844|NCT02446743|2966455|Other|Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||2-Sided|95.0|-20.5|10.6||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615845|NCT02446743|2966455|Other|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose)|vaccine group difference|2.0|||||2-Sided|95.0|-0.33|5.0||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615846|NCT02446743|2966455|Other|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||2-Sided|95.0|-0.9|6.2||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615847|NCT02446743|2966455|Other|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||2-Sided|95.0|-16.0|6.5||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615848|NCT02446743|2966455|Other|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||2-Sided|95.0|4.4|15.0||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615849|NCT02446743|2966455|Other|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|4.0|||||2-Sided|95.0|1.9|13.5||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615850|NCT02446743|2966455|Other|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-31.0|||||2-Sided|95.0|-45.1|-14.6||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615851|NCT02446743|2966455|Other|Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|vaccine group difference|7.0|||||2-Sided|95.0|1.4|15.2||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615852|NCT02446743|2966455|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||2-Sided|95.0|-6.0|16.2||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615853|NCT02446743|2966455|Other|Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose)|vaccine group difference|-27.0|||||2-Sided|95.0|-41.8|-12.9||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615854|NCT02446743|2966455|Other|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||2-Sided|95.0|3.9|12.5||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615855|NCT02446743|2966455|Other|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||2-Sided|95.0|-2.6|10.3||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615856|NCT02446743|2966455|Other|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose)|vaccine group difference|-30.0|||||2-Sided|95.0|-40.4|-19.0||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615857|NCT02446743|2966456|Other|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|5.0|||||2-Sided|95.0|-0.7|11.1||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615858|NCT02446743|2966456|Other|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||2-Sided|95.0|-5.7|11.1||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615859|NCT02446743|2966456|Other|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||2-Sided|95.0|-16.7|8.6||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615860|NCT02446743|2966456|Other|Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|vaccine group difference|12.0|||||2-Sided|95.0|5.9|20.9||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615861|NCT02446743|2966456|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||2-Sided|95.0|-4.7|13.9||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615862|NCT02446743|2966456|Other|Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose)|vaccine group difference|0.0|||||2-Sided|95.0|-15.1|16.1||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615863|NCT02446743|2966456|Other|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose)|vaccine group difference|8.0|||||2-Sided|95.0|4.2|13.2||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615864|NCT02446743|2966456|Other|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||2-Sided|95.0|-3.2|8.5||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615865|NCT02446743|2966456|Other|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||2-Sided|95.0|-13.4|7.1||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615866|NCT02446743|2966456|Other|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|22.0|||||2-Sided|95.0|12.1|32.8||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615867|NCT02446743|2966456|Other|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|3.0|||||2-Sided|95.0|-10.8|18.8||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615868|NCT02446743|2966456|Other|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-31.0|||||2-Sided|95.0|-46.0|-15.5||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615869|NCT02446743|2966456|Other|Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|vaccine group difference|20.0|||||2-Sided|95.0|8.4|31.3||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615870|NCT02446743|2966456|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|vaccine group difference|-7.0|||||2-Sided|95.0|-22.3|9.5||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615871|NCT02446743|2966456|Other|Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose)|vaccine group difference|-18.0|||||2-Sided|95.0|-32.5|-5.8||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615872|NCT02446743|2966456|Other|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose)|vaccine group difference|21.0|||||2-Sided|95.0|12.8|28.3||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615873|NCT02446743|2966456|Other|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose)|vaccine group difference|-3.0|||||2-Sided|95.0|-13.3|8.5||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615874|NCT02446743|2966456|Other|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose)|vaccine group difference|-26.0|||||2-Sided|95.0|-36.6|-15.7||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615875|NCT02446743|2966456|Other|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|2.0|||||2-Sided|95.0|-2.3|7.8||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615876|NCT02446743|2966456|Other|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||2-Sided|95.0|-2.5|11.0||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615877|NCT02446743|2966456|Other|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||2-Sided|95.0|-19.4|9.1||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615878|NCT02446743|2966456|Other|Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||2-Sided|95.0|-3.6|4.4||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615879|NCT02446743|2966456|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||2-Sided|95.0|-3.6|8.8||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615880|NCT02446743|2966456|Other|Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||2-Sided|95.0|-19.2|10.3||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615881|NCT02446743|2966456|Other|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||2-Sided|95.0|-0.9|4.1||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615882|NCT02446743|2966456|Other|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||2-Sided|95.0|-0.9|6.2||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615883|NCT02446743|2966456|Other|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose)|vaccine group difference|-6.0|||||2-Sided|95.0|-15.9|4.6||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615884|NCT02446743|2966456|Other|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|3.0|||||2-Sided|95.0|-0.6|7.8||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615885|NCT02446743|2966456|Other|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|0.0|||||2-Sided|95.0|-4.8|8.1||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615886|NCT02446743|2966456|Other|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-41.0|||||2-Sided|95.0|-53.3|-25.5||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615887|NCT02446743|2966456|Other|Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|vaccine group difference|-1.0|||||2-Sided|95.0|-5.7|3.7||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615888|NCT02446743|2966456|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||2-Sided|95.0|-7.3|10.1||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615889|NCT02446743|2966456|Other|Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose)|vaccine group difference|-48.0|||||2-Sided|95.0|-60.8|-32.0||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615890|NCT02446743|2966456|Other|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||2-Sided|95.0|-1.9|3.9||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615891|NCT02446743|2966456|Other|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||2-Sided|95.0|-4.5|5.2||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615892|NCT02446743|2966456|Other|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose)|vaccine group difference|-45.0|||||2-Sided|95.0|-54.4|-34.3||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615893|NCT02446743|2966457|Other|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month days after booster or 2nd dose)|vaccine group difference|4.0|||||2-Sided|95.0|-0.8|9.5||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615894|NCT02446743|2966457|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||2-Sided|95.0|-4.6|10.1||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616206|NCT02441179|2966892|Superiority or Other|||||||0.14|||||||Chi-squared||||
1615895|NCT02446743|2966457|Other|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose)|vaccine group difference|-2.0|||||2-Sided|95.0|-11.8|11.0||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615896|NCT02446743|2966457|Other|Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|vaccine group difference|9.0|||||2-Sided|95.0|3.7|16.5||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615897|NCT02446743|2966457|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||2-Sided|95.0|-3.2|13.0||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615898|NCT02446743|2966457|Other|Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose)|vaccine group difference|-5.0|||||2-Sided|95.0|-17.8|10.6||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615899|NCT02446743|2966457|Other|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose)|vaccine group difference|6.0|||||2-Sided|95.0|2.8|10.5||||||1 month post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615900|NCT02446743|2966457|Other|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose)|vaccine group difference|2.0|||||2-Sided|95.0|-2.2|7.7||||||7 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615901|NCT02446743|2966457|Other|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose)|vaccine group difference|-4.0|||||2-Sided|95.0|-12.4|5.8||||||3 days post vaccination-The group difference in percentages of subjects with response N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615902|NCT02446743|2966457|Other|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose)|vaccine group difference|1.0|||||2-Sided|95.0|-2.4|5.0||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615903|NCT02446743|2966457|Other|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 38 Group B_0_1 (V72P10) (7 days after booster or 2nd dose)|vaccine group difference|1.0|||||2-Sided|95.0|-3.3|9.0||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615904|NCT02446743|2966457|Other|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-40.0|||||2-Sided|95.0|-51.8|-25.4||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615905|NCT02446743|2966457|Other|Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|vaccine group difference|-1.0|||||2-Sided|95.0|-5.7|3.7||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615906|NCT02446743|2966457|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|vaccine group difference|-3.0|||||2-Sided|95.0|-7.7|5.1||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615907|NCT02446743|2966457|Other|Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose)|vaccine group difference|-46.0|||||2-Sided|95.0|-58.4|-29.8||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615908|NCT02446743|2966457|Other|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose)|vaccine group difference|0.0|||||2-Sided|95.0|-2.7|2.4||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615909|NCT02446743|2966457|Other|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose)|vaccine group difference|-1.0|||||2-Sided|95.0|-3.9|3.6||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615910|NCT02446743|2966457|Other|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose)|vaccine group difference|-44.0|||||2-Sided|95.0|-52.7|-33.1||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616207|NCT02441179|2966893|Superiority or Other|||||||0.57|||||||Chi-squared||||
1615911|NCT02446743|2966458|Other|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose)|Vaccine group difference|14.0|||||2-Sided|95.0|7.6|20.3||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615912|NCT02446743|2966458|Other|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose)|Vaccine group difference|15.0|||||2-Sided|95.0|6.4|24.6||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615913|NCT02446743|2966458|Other|Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1 (V72_41) (1 month after booster or 2nd dose)|Vaccine group difference|12.0|||||2-Sided|95.0|3.6|21.6||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615914|NCT02446743|2966458|Other|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose)|Vaccine group difference|-5.0|||||2-Sided|95.0|-13.6|5.6||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615915|NCT02446743|2966458|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|Vaccine group difference|-2.0|||||2-Sided|95.0|-14.1|12.3||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615916|NCT02446743|2966458|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|Vaccine group difference|-6.0|||||2-Sided|95.0|-19.2|9.2||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615917|NCT02446743|2966458|Other|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose)|Vaccine group difference|-28.0|||||2-Sided|95.0|-38.4|-17.1||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615918|NCT02446743|2966458|Other|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-32.0|||||2-Sided|95.0|-46.5|-15.7||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615919|NCT02446743|2966458|Other|Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose)|Vaccine group difference|-20.0|||||2-Sided|95.0|-35.2|-7.5||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615920|NCT02446743|2966458|Other|Vaccine comparison at Day 31 Group 3B vs Day 61 Group B_0_1 (1 month after booster or 2nd dose)|Vaccine group difference|1.0|||||2-Sided|95.0|-0.9|4.1||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615921|NCT02446743|2966458|Other|Vaccine comparison at Day 31 Group 3B (V72P10) vs Day 61 Group B_0_1 (V72P10) (1 month after booster or 2nd dose)|Vaccine group difference|2.0|||||2-Sided|95.0|-2.3|7.8||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615922|NCT02446743|2966458|Other|Vaccine comparison at Day 31 Group 3B (V72_41) vs Day 61 Group B_0_1(V72_41) (1 month after booster or 2nd dose)|Vaccine group difference|0.0|||||2-Sided|95.0|-3.6|4.4||||||1 month post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615923|NCT02446743|2966458|Other|Vaccine comparison at Day 8 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (7 days after booster or 2nd dose)|Vaccine group difference|2.0|||||2-Sided|95.0|-2.5|11.0||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615924|NCT02446743|2966458|Other|Vaccine comparison at Day 8 Group 3B (V72_41) vs Day 38 Group B_0_1 (V72_41) (7 days after booster or 2nd dose)|Vaccine group difference|0.0|||||2-Sided|95.0|-3.6|8.8||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615925|NCT02446743|2966458|Other|Vaccine comparison at Day 8 Group 3B vs Day 38 Group B_0_1 (7 days after booster or 2nd dose)|Vaccine group difference|1.0|||||2-Sided|95.0|-0.9|6.2||||||7 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615926|NCT02446743|2966458|Other|Vaccine comparison at Day 4 Group 3B (V72P10) vs Day 34 Group B_0_1 (V72P10) (3 days after booster or 2nd dose)|Vaccine group difference|-8.0|||||2-Sided|95.0|-20.0|7.3||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615927|NCT02446743|2966458|Other|Vaccine comparison at Day 4 Group 3B (V72_41) vs Day 34 Group B_0_1 (V72_41) (3 days after booster or 2nd dose)|Vaccine group difference|-4.0|||||2-Sided|95.0|-17.0|11.4||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615928|NCT02446743|2966458|Other|Vaccine comparison at Day 4 Group 3B vs Day 34 Group B_0_1 (3 days after booster or 2nd dose)|Vaccine group difference|-6.0|||||2-Sided|95.0|-15.0|4.5||||||3 days post vaccination-The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1615929|NCT02446743|2966459|Other|1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10) Difference|Vaccine group difference|22.0|||||2-Sided|95.0|10.6|32.9||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615930|NCT02446743|2966459|Other|1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41) Difference|Vaccine group difference|24.0|||||2-Sided|95.0|12.2|35.5||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615931|NCT02446743|2966459|Other|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B_0_1) Difference|Vaccine group difference|23.0|||||2-Sided|95.0|14.7|30.8||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615932|NCT02446743|2966459|Other|1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10) Difference|Vaccine group difference|24.0|||||2-Sided|95.0|12.9|35.1||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615933|NCT02446743|2966459|Other|1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41) Difference|Vaccine group difference|55.0|||||2-Sided|95.0|43.5|64.7||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615934|NCT02446743|2966459|Other|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B_0_1) Difference|Vaccine group difference|38.0|||||2-Sided|95.0|29.8|45.4||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615935|NCT02446743|2966459|Other|1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10) Difference|Vaccine group difference|23.0|||||2-Sided|95.0|14.6|31.9||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615936|NCT02446743|2966459|Other|1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41) Difference|Vaccine group difference|19.0|||||2-Sided|95.0|11.5|28.5||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615937|NCT02446743|2966459|Other|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B_0_1) Difference|Vaccine group difference|22.0|||||2-Sided|95.0|15.9|27.9||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval or the difference was calculated using the method of Miettinen and Nurminen|
1615938|NCT02446743|2966459|Other|1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72P10) vs. Group B_0_1 (V72P10) Difference|Vaccine group difference|26.0|||||2-Sided|95.0|18.3|33.9||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615939|NCT02446743|2966459|Other|1 month post booster/first dose of vaccination: Four-fold Increase [Group 3B (V72_41) vs. Group B_0_1 (V72_41) Difference|Vaccine group difference|29.0|||||2-Sided|95.0|19.3|38.7||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615940|NCT02446743|2966459|Other|1 month post booster/first dose of vaccination: Four-fold Increase (Group 3B vs. Group B_0_1) Difference|Vaccine group difference|27.0|||||2-Sided|95.0|20.7|33.0||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615941|NCT02446743|2966461|Other|Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Ratio of GMTs|2.45|||||2-Sided|95.0|1.79|3.36||||||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615942|NCT02446743|2966461|Other|Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Ratio of GMTs|1.23|||||2-Sided|95.0|0.82|1.82||||||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1616104|NCT02444715|2966672|Superiority or Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1615943|NCT02446743|2966461|Other|Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Ratio of GMTs|2.79|||||2-Sided|95.0|2.04|3.81||||||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615944|NCT02446743|2966461|Other|Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Ratio of GMTs|1.4|||||2-Sided|95.0|0.9|2.18||||||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615945|NCT02446743|2966461|Other|"Vaccine comparison Post-booster or post-1st dose in V72_75 (Group 3B vs. Group B~_0_1)"|Ratio of GMTs|2.6|||||2-Sided|95.0|2.08|3.25||||||Post booster/Post first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615946|NCT02446743|2966461|Other|"Vaccine comparison Pre-booster or pre-1st dose in V72_75 (Group 3B vs. Group B~_0_1)"|Ratio of GMTs|1.3|||||2-Sided|95.0|0.97|1.75||||||Pre booster/Pre first dose-Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615947|NCT02446743|2966461|Other|Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Ratio of GMTs|4.36|||||2-Sided|95.0|2.88|6.58||||||Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615948|NCT02446743|2966461|Other|Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Ratio of GMTs|1.64|||||2-Sided|95.0|1.22|2.2||||||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615949|NCT02446743|2966461|Other|Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Ratio of GMTs|8.27|||||2-Sided|95.0|5.83|12.0||||||Post booster/Post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615950|NCT02446743|2966461|Other|Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Ratio of GMTs|1.32|||||2-Sided|95.0|1.13|1.54||||||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615951|NCT02446743|2966461|Other|"Vaccine comparison Post-booster or post-1st dose in V72_75 (Group 3B vs. Group B~_0_1)"|Ratio of GMTs|5.9|||||2-Sided|95.0|4.49|7.76||||||Post booster dose/ post first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615952|NCT02446743|2966461|Other|"Vaccine comparison Pre-booster or pre-1st dose in V72_75 (Group 3B vs. Group B~_0_1)"|Ratio of GMTs|1.48|||||2-Sided|95.0|1.24|1.75||||||Pre booster/Pre first dose-Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615953|NCT02446743|2966461|Other|Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Ratio of GMTs|63.0|||||2-Sided|95.0|41.0|95.0||||||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615954|NCT02446743|2966461|Other|Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Ratio of GMTs|14.0|||||2-Sided|95.0|8.99|22.0||||||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615955|NCT02446743|2966461|Other|Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Ratio of GMTs|74.0|||||2-Sided|95.0|51.0|107.0||||||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615956|NCT02446743|2966461|Other|Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Ratio of GMTs|18.0|||||2-Sided|95.0|13.0|26.0||||||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615957|NCT02446743|2966461|Other|"Vaccine comparison Post-booster or post-1st dose in V72_75 (Group 3B vs. Group B~_0_1)"|Ratio of GMTs|68.0|||||2-Sided|95.0|51.0|90.0||||||Post booster/Post first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615958|NCT02446743|2966461|Other|"Vaccine comparison Pre-booster or pre-1st dose in V72_75 (Group 3B vs. Group B~_0_1)"|Ratio of GMTs|16.0|||||2-Sided|95.0|12.0|21.0||||||Pre booster/Pre first dose-Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615959|NCT02446743|2966461|Other|Vaccine comparison- post-booster or post-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Ratio of GMTs|11.0|||||2-Sided|95.0|7.75|16.0||||||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615960|NCT02446743|2966461|Other|Vaccine comparison- Pre-booster or pre-1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Ratio of GMTs|3.04|||||2-Sided|95.0|2.2|4.2||||||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615961|NCT02446743|2966461|Other|Vaccine comparison-post-booster or post-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Ratio of GMTs|12.0|||||2-Sided|95.0|8.22|17.0||||||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615962|NCT02446743|2966461|Other|Vaccine comparison-Pre-booster or pre-1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Ratio of GMTs|2.18|||||2-Sided|95.0|1.7|2.79||||||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615963|NCT02446743|2966461|Other|"Vaccine comparison Post-booster or post-1st dose in V72_75 (Group 3B vs. Group B~_0_1)"|Ratio of GMTs|11.0|||||2-Sided|95.0|8.85|15.0||||||Post booster/Post first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1615964|NCT02446743|2966461|Other|"Vaccine comparison Pre-booster or pre-1st dose in V72_75 (Group 3B vs. Group B~_0_1)"|Ratio of GMTs|2.6|||||2-Sided|95.0|2.11|3.2||||||Pre booster/Pre first dose-Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1615965|NCT02446743|2966462|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|13.0|||||2-Sided|95.0|6.4|20.1||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615966|NCT02446743|2966462|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|28.0|||||2-Sided|95.0|17.9|37.8||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615967|NCT02446743|2966462|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1)|vaccine group difference|19.0|||||2-Sided|95.0|12.9|24.6||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615968|NCT02446743|2966462|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|41.0|||||2-Sided|95.0|29.9|50.2||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615969|NCT02446743|2966462|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|51.0|||||2-Sided|95.0|39.3|60.9||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615970|NCT02446743|2966462|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1)|vaccine group difference|43.0|||||2-Sided|95.0|35.1|50.6||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615971|NCT02446743|2966462|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|30.0|||||2-Sided|95.0|22.9|38.1||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615972|NCT02446743|2966462|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|23.0|||||2-Sided|95.0|15.5|32.0||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615973|NCT02446743|2966462|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1)|vaccine group difference|27.0|||||2-Sided|95.0|21.6|33.0||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616208|NCT02441179|2966894|Superiority or Other|||||||0.16|||||||Kruskal-Wallis||||
1615974|NCT02446743|2966462|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|34.0|||||2-Sided|95.0|26.6|42.2||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615975|NCT02446743|2966462|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|49.0|||||2-Sided|95.0|38.9|58.5||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615976|NCT02446743|2966462|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1)|vaccine group difference|40.0|||||2-Sided|95.0|33.9|46.3||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615977|NCT02446743|2966463|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|8.0|||||2-Sided|95.0|2.7|14.7||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615978|NCT02446743|2966463|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|20.0|||||2-Sided|95.0|12.6|29.0||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615979|NCT02446743|2966463|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1)|vaccine group difference|13.0|||||2-Sided|95.0|8.8|18.3||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615980|NCT02446743|2966463|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|33.0|||||2-Sided|95.0|23.0|42.5||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615981|NCT02446743|2966463|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|58.0|||||2-Sided|95.0|46.6|67.3||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615982|NCT02446743|2966463|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1)|vaccine group difference|43.0|||||2-Sided|95.0|35.2|49.9||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615983|NCT02446743|2966463|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|19.0|||||2-Sided|95.0|13.3|26.4||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615984|NCT02446743|2966463|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|19.0|||||2-Sided|95.0|12.1|27.5||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615985|NCT02446743|2966463|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1)|vaccine group difference|19.0|||||2-Sided|95.0|14.3|24.3||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615986|NCT02446743|2966463|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|26.0|||||2-Sided|95.0|19.2|33.1||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615987|NCT02446743|2966463|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|31.0|||||2-Sided|95.0|21.8|40.3||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615988|NCT02446743|2966463|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|27.0|||||2-Sided|95.0|21.9|33.3||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615989|NCT02446743|2966464|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|6.0|||||2-Sided|95.0|1.5|12.2||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615990|NCT02446743|2966464|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|20.0|||||2-Sided|95.0|12.8|28.6||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615991|NCT02446743|2966464|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1)|vaccine group difference|12.0|||||2-Sided|95.0|8.0|16.8||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1615992|NCT02446743|2966464|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|21.0|||||2-Sided|95.0|15.6|28.8||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615993|NCT02446743|2966464|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|18.0|||||2-Sided|95.0|10.7|27.0||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615994|NCT02446743|2966464|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|20.0|||||2-Sided|95.0|15.0|25.4||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615995|NCT02446743|2966465|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|41.0|||||2-Sided|95.0|33.6|47.2||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615996|NCT02446743|2966465|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|31.0|||||2-Sided|95.0|22.0|40.1||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615997|NCT02446743|2966465|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|54.0|||||2-Sided|95.0|43.0|63.3||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615998|NCT02446743|2966465|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|15.0|||||2-Sided|95.0|11.0|20.1||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1615999|NCT02446743|2966465|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|16.0|||||2-Sided|95.0|10.8|23.1||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1616000|NCT02446743|2966465|Other|Vaccine comparison at 1 month after booster /1st dose in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|13.0|||||2-Sided|95.0|8.0|21.6||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference were calculated using the method of Miettinen and Nurminen|
1616001|NCT02446743|2966470|Other|Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|vaccine group ratio of GMTs|1.2|||||2-Sided|95.0|0.81|1.78||||||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1616002|NCT02446743|2966470|Other|Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|vaccine group ratio of GMTs|1.32|||||2-Sided|95.0|0.85|2.05||||||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1616003|NCT02446743|2966470|Other|Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group ratio of GMTs|1.26|||||2-Sided|95.0|0.94|1.68||||||Adjusted geometric mean titers for M10713 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1616004|NCT02446743|2966470|Other|Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|vaccine group ratio of GMTs|1.7|||||2-Sided|95.0|1.27|2.28||||||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1616005|NCT02446743|2966470|Other|Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|vaccine group ratio of GMTs|1.3|||||2-Sided|95.0|1.11|1.51||||||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1616006|NCT02446743|2966470|Other|Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group ratio of GMTs|1.5|||||2-Sided|95.0|1.26|1.78||||||Adjusted geometric mean titers for NZ98/254 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country|
1616105|NCT02444715|2966673|Superiority or Other|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616007|NCT02446743|2966470|Other|Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|vaccine group ratio of GMTs|14.0|||||2-Sided|95.0|9.05|20.0||||||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1616008|NCT02446743|2966470|Other|Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|vaccine group ratio of GMTs|20.0|||||2-Sided|95.0|14.0|28.0||||||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1616009|NCT02446743|2966470|Other|Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group ratio of GMTs|16.0|||||2-Sided|95.0|12.0|21.0||||||Adjusted geometric mean titers for 5/99 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1616010|NCT02446743|2966470|Other|Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|vaccine group ratio of GMTs|2.96|||||2-Sided|95.0|2.15|4.07||||||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1616011|NCT02446743|2966470|Other|Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|vaccine group ratio of GMTs|2.13|||||2-Sided|95.0|1.66|2.72||||||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1616012|NCT02446743|2966470|Other|Vaccine Comparison at Persistence at 4 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|vaccine group ratio of GMTs|2.54|||||2-Sided|95.0|2.07|3.12||||||Adjusted geometric mean titers for H44/76 indicator strain were obtained by exponentiating (base 10) the least square means and the lower and upper limits of the 95% confidence intervals of the log-transformed titers obtained from an ANOVA estimation adjusting for vaccine group and country.|
1616013|NCT02446743|2966471|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|4.0|||||2-Sided|95.0|-7.8|14.7||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616014|NCT02446743|2966471|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|3.0|||||2-Sided|95.0|-9.8|15.2||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616015|NCT02446743|2966471|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|2.0|||||2-Sided|95.0|-6.8|10.0||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616016|NCT02446743|2966471|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|15.0|||||2-Sided|95.0|7.5|22.6||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616017|NCT02446743|2966471|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|5.0|||||2-Sided|95.0|1.2|9.7||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616018|NCT02446743|2966471|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|9.0|||||2-Sided|95.0|4.9|13.6||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616019|NCT02446743|2966471|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|65.0|||||2-Sided|95.0|55.2|73.7||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616020|NCT02446743|2966471|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|70.0|||||2-Sided|95.0|60.8|77.0||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616021|NCT02446743|2966471|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|vaccine group difference|66.0|||||2-Sided|95.0|59.6|72.4||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616022|NCT02446743|2966471|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|21.0|||||2-Sided|95.0|12.3|29.9||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616106|NCT02444715|2966673|Superiority or Other|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616023|NCT02446743|2966471|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|12.0|||||2-Sided|95.0|7.5|18.1||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616024|NCT02446743|2966471|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|15.0|||||2-Sided|95.0|10.1|20.9||||||The group difference in percentages of subjects with response against N. meningitidis serogroup B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616025|NCT02446743|2966472|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|4.0|||||2-Sided|95.0|-6.4|14.5||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616026|NCT02446743|2966472|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|9.0|||||2-Sided|95.0|-3.3|21.4||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616027|NCT02446743|2966472|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|5.0|||||2-Sided|95.0|-3.4|12.8||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616028|NCT02446743|2966472|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|13.0|||||2-Sided|95.0|4.5|22.0||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616029|NCT02446743|2966472|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|7.0|||||2-Sided|95.0|3.3|12.3||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616030|NCT02446743|2966472|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|9.0|||||2-Sided|95.0|3.7|14.0||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616031|NCT02446743|2966472|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|64.0|||||2-Sided|95.0|53.6|72.3||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616032|NCT02446743|2966472|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|74.0|||||2-Sided|95.0|65.3|81.3||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616033|NCT02446743|2966472|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|68.0|||||2-Sided|95.0|60.8|73.7||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen|
1616034|NCT02446743|2966472|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|26.0|||||2-Sided|95.0|16.4|35.3||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616035|NCT02446743|2966472|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|21.0|||||2-Sided|95.0|14.6|28.9||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616036|NCT02446743|2966472|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|22.0|||||2-Sided|95.0|16.5|28.6||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616037|NCT02446743|2966474|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1(V72P10)]|Vaccine group difference|0.0|||||2-Sided|95.0|-10.0|9.5||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616038|NCT02446743|2966474|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1(V72_41)]|vaccine group differences|12.0|||||2-Sided|95.0|0.33|24.2||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616039|NCT02446743|2966474|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|4.0|||||2-Sided|95.0|-3.4|11.9||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain M10713 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616040|NCT02446743|2966474|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|30.0|||||2-Sided|95.0|20.0|39.6||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616041|NCT02446743|2966474|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [(Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine groups difference|22.0|||||2-Sided|95.0|13.2|30.1||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616042|NCT02446743|2966474|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|vaccine group difference|25.0|||||2-Sided|95.0|18.2|31.4||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain H44/76and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616043|NCT02446743|2966475|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|10.0|||||2-Sided|95.0|4.3|15.9||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616044|NCT02446743|2966475|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10 vs. Group B_0_1 (V72P10)]|Vaccine group difference|14.0|||||2-Sided|95.0|4.9|24.2||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616045|NCT02446743|2966475|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine group difference|9.0|||||2-Sided|95.0|5.3|14.8||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain NZ98/254 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616046|NCT02446743|2966475|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 (Group 3B vs. Group B_0_1)|Vaccine group difference|68.0|||||2-Sided|95.0|60.5|73.5||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616047|NCT02446743|2966475|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [Group 3B (V72P10) vs. Group B_0_1 (V72P10)]|Vaccine group difference|60.0|||||2-Sided|95.0|49.9|69.2||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616048|NCT02446743|2966475|Other|Vaccine comparison at Persistence at 4/7.5 years/Baseline in V72_75 [(Group 3B (V72_41) vs. Group B_0_1 (V72_41)]|Vaccine Group Difference|77.0|||||2-Sided|95.0|68.1|84.1||||||The group difference in percentages of subjects with response against N. meningitidis group B indicator strain 5/99 and the associated confidence interval for the difference was calculated using the method of Miettinen and Nurminen.|
1616049|NCT02446613|2966496|Superiority or Other||Median Difference (Final Values)|6.6|Standard Deviation|0.007|||2-Sided|95.0|-13.69|28.04|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.2525||
1616050|NCT02446613|2966497|Superiority or Other||Median Difference (Final Values)|1.1|Standard Deviation|0.008|||2-Sided|95.0|-17.47|19.2|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.4528||
1616051|NCT02446613|2966498|Superiority or Other||Median Difference (Final Values)|4.3|Standard Deviation|0.007|||2-Sided|95.0|-14.97|24.38|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.3266||
1616052|NCT02446613|2966499|Superiority or Other||Median Difference (Final Values)|4.6|Standard Deviation|0.006|||2-Sided|95.0|-10.7|19.71|||||The posterior probability statement value for percentage reduction in the reductions of PNIF ≤0 was 0.2665.||
1616053|NCT02446613|2966500|Superiority or Other||Median Difference (Final Values)|1.9|Standard Deviation|0.006|||2-Sided|95.0|-1.86|5.34|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.1453.||
1616054|NCT02446613|2966501|Superiority or Other||Median Difference (Final Values)|0.4|Standard Deviation|0.007|||2-Sided|95.0|-1.08|1.87|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.2876.||
1616055|NCT02446613|2966502|Superiority or Other||Mean Difference (Final Values)|1.0|Standard Deviation|0.007|||2-Sided|95.0|-1.98|3.75|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.2417.||
1616056|NCT02446613|2966503|Superiority or Other||Mean Difference (Final Values)|2.1|Standard Deviation|0.007|||2-Sided|95.0|-1.41|5.43|||||The posterior probability statement value for change from baseline in post-challenge TNSS ≤0 was 0.1071.||
1616057|NCT02446496|2966505|Superiority or Other|||||||0.267|||||||Wilcoxon's Signed-Rank Test|Comparison of T-max between Treatment A and Treatment B.|||
1616058|NCT02446496|2966506|Non-Inferiority or Equivalence|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|103.13|||||2-Sided|90.0|91.19|116.62|||||Comparison of AUC(0-infinity) between Treatment A and Treatment B||
1616059|NCT02446496|2966506|Non-Inferiority or Equivalence|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|102.31|||||2-Sided|90.0|90.46|115.7|||||Comparison of AUC (0-t) between Treatment A and Treatment B||
1616060|NCT02446496|2966507|Non-Inferiority or Equivalence|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point estimate percent|95.91|||||2-Sided|90.0|85.67|107.37|||||||
1616061|NCT02446483|2966509|Superiority or Other|||||||0.0029|||||||Wilcoxon's Signed-Rank Test||||
1616062|NCT02446483|2966510|Non-Inferiority or Equivalence|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Point Estimate Percent|98.05|||||2-Sided|90.0|91.81|104.71||||||Comparison of Treatment A- rabeprazole 20 mg and Treatment B- rabeprazole 20 mg for AUC0-infinity.|
1616065|NCT02446418|2966512|Superiority||Adjusted Odds Ratio|1.41||||0.566|2-Sided|95.0|0.43|4.6|||Regression, Logistic|||Week 24|The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.
1616066|NCT02446418|2966512|Superiority||Adjusted Odds Ratio|1.11||||0.82|2-Sided|95.0|0.47|2.62|||Regression, Logistic|||Week 12|The analysis method was logistic regression adjusted for randomized treatment, correct use of inhaler device at Baseline, gender, age and country.
1616067|NCT02446418|2966513|Non-Inferiority|Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.|Mean Difference (Net)|0.4||||0.224|2-Sided|95.0|-0.3|1.1|||Mixed model repeated measures (MMRM)||||The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6, Week 12, Week 18 and Week 24), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by visit interaction, gender, age, country and participant fitted as a random factor. The REML estimation approach was used with a default covariance structure of unstructured.
1616068|NCT02446418|2966514|Non-Inferiority|Non-inferiority of fixed combination FF/VI to usual ICS/LABA in inhalation powder was assessed assuming a non-inferiority margin of -1.5.|Mean Difference (Net)|0.8||||0.033|2-Sided|95.0|0.1|1.5|||Mixed model repeated measures (MMRM)||||The analysis method was an MMRM adjusted for randomized treatment, visit (Week 6 and Week 12), Baseline ACT total score, randomized treatment-by-visit interaction, Baseline ACT total score-by-visit interaction, gender, age, country and participant fitted as a random factor. The Restricted Maximum Likelihood (REML) estimation approach was used with a default covariance structure of unstructured.
1616069|NCT02446314|2966515|Superiority||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate||||
1616070|NCT02446314|2966516|Superiority||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate||||
1616071|NCT02446314|2966517|Superiority||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate||||
1616072|NCT02446314|2966518|Superiority||||||>|0.05|||||||Linear Mixed Model / Baseline Covariate||||
1616073|NCT02446314|2966519|Superiority||||||=|0|||||||Linear Mixed Model / Baseline Covariate||||
1616074|NCT02446171|2966540|Superiority or Other||Ratio#|102.5|||||2-Sided|90.0|93.13|111.82|||||||
1616075|NCT02446171|2966540|Superiority or Other||Ratio#|100.56|||||2-Sided|90.0|91.8|110.16|||||||
1616076|NCT02446171|2966540|Superiority or Other||Ratio#|97.05|||||2-Sided|90.0|88.09|106.92|||||||
1616077|NCT02446171|2966541|Superiority or Other||Ratio#|94.83|||||2-Sided|90.0|89.2|100.82|||||||
1616078|NCT02446171|2966541|Superiority or Other||Ratio#|100.44|||||2-Sided|90.0|93.65|107.72|||||||
1616079|NCT02446171|2966541|Superiority or Other||Ratio#|98.79|||||2-Sided|90.0|92.24|105.8|||||||
1616080|NCT02446171|2966542|Superiority or Other||Ratio#|94.37|||||2-Sided|90.0|88.7|100.4|||||||
1616081|NCT02446171|2966542|Superiority or Other||Ratio#|100.04|||||2-Sided|90.0|93.17|107.43|||||||
1616082|NCT02446171|2966542|Superiority or Other||Ratio#|98.89|||||2-Sided|90.0|92.4|105.84|||||||
1616083|NCT02445911|2966563|Other||Least-squares Mean Difference|-5.05|||||2-Sided|95.0|-21.97|11.88|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.||
1616084|NCT02445911|2966563|Other||Least-squares Mean Difference|-2.97|||||2-Sided|95.0|-19.65|13.72|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.||
1616085|NCT02445911|2966563|Other||Least-squares Mean Difference|-6.78|||||2-Sided|95.0|-23.75|10.18|||||Least-squares means have baseline and site as covariates. Placebo was the reference group.||
1616086|NCT02445287|2966622|Superiority or Other|||||||0.012||||||level of significance (alpha) = 0.05|t-test, 1 sided||||
1616087|NCT02445287|2966623|Non-Inferiority or Equivalence|Equivalence interval = (-0.25, 0.25)||||||0||||||level of significance (alpha) = 0.05|Equivalence test||||
1616088|NCT02445287|2966624|Superiority or Other|||||||0||||||Level of significance (alpha) = 0.05|t-test, 1 sided||||
1616089|NCT02445287|2966625|Superiority or Other|||||||0.92||||||Level of significance (alpha) = 0.05|t-test, 2 sided||||
1616090|NCT02445196|2966626|Superiority or Other||Mean Difference (Net)|2.78||||0.113|2-Sided||||||t-test, 2 sided||||
1616091|NCT02445196|2966627|Superiority or Other||Mean Difference (Net)|2.72||||0.005|2-Sided||||||ANOVA||||
1616092|NCT02445196|2966628|Superiority or Other||Mean Difference (Net)|0.75||||0.007|2-Sided||||||ANOVA||||
1616093|NCT02445196|2966629|Superiority or Other||Mean Difference (Net)|4.87||||0.086|2-Sided||||||ANOVA||||
1616094|NCT02445196|2966630|Superiority or Other||Mean Difference (Net)|4.57||||0.035|2-Sided||||||ANOVA|||Repeated measures ANOVAs assessed the condition by time (baseline to posttreatment) interaction effects covarying PTSD treatment. Following the ITT principle, data from all randomized participants were analyzed and multiple imputation replaced missing values. A power analysis indicated that to achieve 80% power to detect an effect size in the magnitude (i.e., d = 0.25 to .33) with alpha of .05 and a correlation between repeated measures of .5, 60 participants per condition would be needed.|
1616095|NCT02444988|2966633|Superiority||Odds Ratio (OR)|0.84|||<|0.05|2-Sided|95.0|0.73|0.97|||Regression, Logistic||||
1616096|NCT02444988|2966634|Superiority||Odds Ratio (OR)|0.87|||<|0.05|2-Sided|95.0|0.77|0.99|||Regression, Logistic||||
1616097|NCT02444715|2966670|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616098|NCT02444715|2966670|Superiority or Other|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616099|NCT02444715|2966671|Superiority or Other|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||"High intensity~H0: no change between baseline and post-intervention"|
1616100|NCT02444715|2966671|Superiority or Other|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||"High intensity~H0: no change between baseline and post-intervention"|
1616101|NCT02444715|2966671|Superiority or Other|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||"Medium intensity~H0: no change between baseline and post-intervention"|
1616102|NCT02444715|2966671|Superiority or Other|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||"Medium intensity~H0: no change between baseline and post-intervention"|
1616103|NCT02444715|2966672|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616109|NCT02444715|2966675|Superiority or Other|||||||0.43|||||||t-test, 2 sided|||H0: no change between baseline and post-intervention|
1616110|NCT02444715|2966675|Superiority or Other|||||||0.9|||||||t-test, 2 sided|||H0: no change between baseline and post-intervention|
1616111|NCT02444715|2966676|Superiority or Other|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616112|NCT02444715|2966676|Superiority or Other|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616113|NCT02444715|2966677|Superiority or Other|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616114|NCT02444715|2966677|Superiority or Other|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616115|NCT02444715|2966678|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616116|NCT02444715|2966678|Superiority or Other|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616117|NCT02444715|2966679|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616118|NCT02444715|2966679|Superiority or Other|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616119|NCT02444715|2966680|Superiority or Other|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616120|NCT02444715|2966680|Superiority or Other|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||H0: no change between baseline and post-intervention|
1616121|NCT02444715|2966681|Superiority or Other|||||||0.03|||||||t-test, 2 sided|||H0: no change between baseline and post-intervention|
1616122|NCT02444715|2966681|Superiority or Other|||||||0.96|||||||t-test, 2 sided|||H0: no change between baseline and post-intervention|
1616123|NCT02444533|2966684|Superiority|||||||1|||||||t-test, 2 sided|||Comparison between groups at 7 days. Statistical significance was defined as a p-value less than 0.05.|
1616124|NCT02444533|2966685|Superiority|||||||0.835|||||||t-test, 2 sided|||Comparison between groups for oxycodone usage. Statistical significance was defined as a p-value less than 0.05.|
1616125|NCT02444533|2966685|Superiority|||||||0.97|||||||t-test, 2 sided|||Comparison between groups for acetaminophen usage. Statistical significance was defined as a p-value less than 0.05.|
1616126|NCT02444533|2966685|Superiority|||||||0.65|||||||t-test, 2 sided|||Comparison between groups for ibuprofen usage. Statistical significance was defined as a p-value less than 0.05.|
1616127|NCT02444533|2966686|Superiority|||||||0.445|||||||t-test, 2 sided|||Comparison between groups for pain at 14 days after surgery. Statistical significance was defined as a p-value less than 0.05.|
1616128|NCT02444533|2966686|Superiority|||||||0.043|||||||t-test, 2 sided|||Comparison between groups for pain on day of surgery. Statistical significance was defined as a p-value less than 0.05.|
1616129|NCT02444182|2966693|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Deviation|0.09||0.909|2-Sided||||||paired t-test|||Null hypothesis was no difference in plaque index between probiotics and control groups|
1616130|NCT02444182|2966694|Superiority or Other||Mean Difference (Net)|0.28|Standard Deviation|0.21||0.015|2-Sided||||||paired t-test|||Null hypothesis was no difference in Gingival index between probiotics and control groups|
1616131|NCT02444143|2966695|Other|||||||0.9|||||||t-test, 2 sided||||
1616132|NCT02444143|2966696|Other|||||||0.29|||||||t-test, 2 sided||||
1616133|NCT02443805|2966702|Superiority||||||<|0.0001||||||Source Model: Type III effects Covariates: Treatment group, Gender, Age Class, Sensitization Status, Asthma Status, Pooled Center, Baseline Average RTSS.|ANCOVA||||
1616134|NCT02443740|2966709|Superiority or Other||Adjusted Geometric Mean Ratio|15.21|||||2-Sided|90.0|13.29|17.42|||||Values were back-transformed from the log scale.||
1616135|NCT02443740|2966711|Superiority or Other||Adjusted Geometric Mean Ratio|16.71|||||2-Sided|90.0|15.35|18.18|||||Values were back-transformed from the log scale.||
1616136|NCT02443740|2966713|Superiority or Other||Adjusted Geometric Mean Ratio.|29.76|||||2-Sided|90.0|24.17|36.64|||||Values have been back-transformed from the log scale.||
1616137|NCT02443740|2966714|Superiority or Other||Adjusted Geometric Mean Ratio|68.62|||||2-Sided|90.0|63.27|74.41|||||Values have been back-transformed from the log scale.||
1616138|NCT02443740|2966715|Superiority or Other||Adjusted Geometric Mean Ratio|65.58|||||2-Sided|90.0|62.18|69.16|||||Values have been back-transformed from the log scale.||
1616139|NCT02443740|2966720|Superiority or Other||Adjusted Geometric Mean Ratio|80.12|||||2-Sided|90.0|58.92|108.94|||||Values have been back-transformed from the log scale.||
1616140|NCT02443740|2966721|Superiority or Other||Adjusted Geometric Mean Ratio|80.6|||||2-Sided|90.0|59.74|108.75|||||Values have been back-transformed from the log scale.||
1616141|NCT02443740|2966722|Superiority or Other||Adjusted Geometric Mean Ratio.|39.58|||||2-Sided|90.0|30.14|51.99|||||Values have been back-transformed from the log scale.||
1616142|NCT02443688|2966737|Other|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.57|Standard Error of the Mean|0.18|||2-Sided|95.0|0.31|1.05|||||||
1616143|NCT02443688|2966737|Other|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.62|Standard Error of the Mean|0.18|||2-Sided|95.0|0.3|1.27|||||||
1616144|NCT02443688|2966737|Other|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.52|Standard Error of the Mean|0.2|||2-Sided|95.0|0.25|1.1|||||||
1616145|NCT02443688|2966738|Other|Group Rate with 95% CI|see Estimation Comment below|1.04|Standard Error of the Mean|0.18|||2-Sided|95.0|0.74|1.46|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.||
1616146|NCT02443688|2966738|Other|Single Group Rate with 95% CI|see Estimation Comment below|1.61|Standard Error of the Mean|0.34|||2-Sided|95.0|1.07|2.42|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.||
1616147|NCT02443688|2966738|Other|Single Group Rate with 95% CI|see Estimation Comment below|1.28|Standard Error of the Mean|0.28|||2-Sided|95.0|0.84|1.96|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.||
1616148|NCT02443688|2966738|Other|Single Group Rate with 95% CI|see Estimation Comment below|0.84|Standard Error of the Mean|0.23|||2-Sided|95.0|0.49|1.44|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.||
1616149|NCT02443688|2966744|Other|95% 2-sided confidence interval for the Hazard Ratio Relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.87|Standard Error of the Mean|0.16|||2-Sided|95.0|0.61|1.25|||||||
1616150|NCT02443688|2966744|Other|95% 2-sided confidence interval for the Hazard Ratio relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.86|Standard Error of the Mean|0.18|||2-Sided|95.0|0.56|1.31|||||||
1616151|NCT02443688|2966744|Other|95% 2-sided confidence interval for the Hazard Ratio relative to Placebo unadjusted for multiple comparisons|Hazard Ratio (HR)|0.88|Standard Error of the Mean|0.19|||2-Sided|95.0|0.58|1.34|||||||
1616152|NCT02443688|2966745|Other|Pooled Group Rate with 95% CI|see Estimation Comment below|1.51|Standard Error of the Mean|0.14|||2-Sided|95.0|1.26|1.81|||||Estimated using negative binomial distribution unadjusted for multiple comparisons.||
1616153|NCT02443688|2966745|Other|Single Group Rate with 95% CI|see Estimation Comment below|1.56|Standard Error of the Mean|0.2|||2-Sided|95.0|1.21|2.01|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.||
1616154|NCT02443688|2966745|Other|Single Group Rate with 95% CI|see Estimation Comment below|1.46|Standard Error of the Mean|0.19|||2-Sided|95.0|1.13|1.89|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.||
1616155|NCT02443688|2966745|Other|Single Group Rate with 95% CI|see Estimation Comment below|1.57|Standard Error of the Mean|0.2|||2-Sided|95.0|1.22|2.02|||||Estimated using negative binomial distribution by treatment group unadjusted for multiple comparisons.||
1616156|NCT02443688|2966746|Superiority|Difference from placebo of pooled arms (100mg CTX-4430 and 50mg CTX-4430) in change from baseline in ppFEV1 at Week 48.|Mean Difference (Final Values)|0.16|Standard Error of the Mean|1.2||0.45|2-Sided|95.0|-2.2|2.5||0.1 alpha level (2-sided) prespecified|ANOVA||||
1616157|NCT02443688|2966746|Other|Single Group Difference from Placebo Mean Change from Baseline with 95% CI|Mean Difference (Final Values)|-1.07|Standard Error of the Mean|1.37|||2-Sided|95.0|-3.78|1.64|||||||
1616158|NCT02443688|2966746|Other|Single Group Difference from Placebo Mean Change from Baseline with 95% confidence interval (CI)|Mean Difference (Final Values)|1.39|Standard Error of the Mean|1.38|||2-Sided|95.0|-1.34|4.12|||||||
1616159|NCT02443298|2966780|Superiority||Mean Difference (Final Values)|0.149|Standard Error of the Mean|0.115||0.1985|2-Sided|80.0|0.0|0.297|||ANCOVA||Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting an analysis of covariance (ANCOVA) model separately for each week including treatment, OCS use at baseline, and baseline as covariates. The weekly averages of daily measurements are calculated before fitting the model.|
1616160|NCT02443298|2966781|Superiority||Mean Difference (Final Values)|-0.068|Standard Error of the Mean|0.045||0.1377|2-Sided|80.0|-0.126|-0.009|||Mixed Models Analysis|Unstructured covariance structure for within−patient variation|Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment−by−test day interaction, baseline, and baseline−by−test day interaction as covariates patient as a random effect.|
1616161|NCT02443298|2966782|Superiority||Mean Difference (Final Values)|-0.039|Standard Error of the Mean|0.051||0.4423|2-Sided|80.0|-0.104|0.026|||Mixed Models Analysis|Unstructured covariance structure for within−patient variation|Comparison of Risankizumab to Placebo|The adjusted mean (SE) are obtained from fitting a mixed effect repeated measures (MMRM) model including treatment, OCS use at baseline, test day, treatment−by−test day interaction, baseline, and baseline−by−test day interaction as covariates patient as a random effect.|
1616162|NCT02443298|2966783|Superiority||Rate Ratio|1.1317|Standard Error of the Mean|0.237||0.555|2-Sided|80.0|0.8652|1.4803|||Negative binomial regression||Comparison of Risankizumab to Placebo|Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.|
1616163|NCT02443298|2966784|Superiority||Hazard Ratio (HR)|1.18||||0.4619|2-Sided|80.0|0.88|1.57|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|Time to first event is obtained from fitting a Cox proportional−hazards model including treatment, and OCS use at baseline as covariate|
1616164|NCT02443298|2966785|Superiority||Rate Ratio|1.4937|Standard Error of the Mean|0.22||0.0065|2-Sided|80.0|1.2366|1.8044|||Negative binomial regression||Comparison of Risankizumab to Placebo|Annualized rate is obtained from fitting a negative binomial regression including logarithm of the exposure as an offset, treatment, and OCS use at baseline as covariate.|
1616165|NCT02443298|2966786|Superiority||Hazard Ratio (HR)|1.47||||0.0131|2-Sided|80.0|1.2|1.79|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.|
1616166|NCT02443298|2966787|Superiority||Hazard Ratio (HR)|1.46||||0.0255|2-Sided|80.0|1.18|1.81|||Cox proportional hazards model||Comparison of Risankizumab to Placebo|This was analyzed by using a Cox proportional hazards model that included treatment and the stratification factor of OCS use at baseline as fixed effects.|
1616167|NCT02442830|2966794|Other|Log rank test||||||0.002|||||||Log Rank||||
1616168|NCT02442700|2966808|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis||||
1616169|NCT02442687|2966825|Other|||||||0.253||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was <0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.|||
1616170|NCT02442687|2966825|Other|||||||0.0882||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was <0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.|||
1616171|NCT02442687|2966826|Other|||||||0.1806||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was <0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.|||
1616209|NCT02441179|2966895|Superiority or Other|||||||0.012|||||||Kruskal-Wallis||||
1616172|NCT02442687|2966826|Other|||||||0.2591||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was <0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.|||
1616173|NCT02442687|2966827|Other|||||||0.4968||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was <0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.|||
1616174|NCT02442687|2966827|Other|||||||0.5276||||||The p-value is not adjusted for multiple comparisons. The threshold for statistical significance was <0.05.|ANCOVA|The change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.|||
1616175|NCT02442687|2966828|Other|||||||0.1731||||||The p-value was not adjusted for multiple comparison. The threshold for statistical significance was <0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.|||
1616176|NCT02442687|2966828|Other|||||||0.034||||||The p-value was not adjusted for multiple comparison. The threshold for statistical significance was <0.05.|ANCOVA|Change from baseline as the dependent variable, baseline value as a covariate, and treatment group and diabetes stratum as factors.|||
1616177|NCT02442206|2966846|Superiority||Mean Difference (Net)|0.281||||0.0182|2-Sided|95.0|0.05|0.512|||ANOVA|||RVCO|
1616178|NCT02442206|2966846|Superiority||Mean Difference (Net)|0.337||||0.0032|2-Sided|95.0|0.118|0.555|||ANOVA|||LVCO|
1616179|NCT02442206|2966847|Superiority||Mean Difference (Net)|9.357||||0.0002|2-Sided|95.0|4.649|14.065|||ANOVA||||
1616180|NCT02442206|2966848|Superiority||Mean Difference (Net)|2.095||||0.1236|2-Sided|95.0|-0.591|4.782|||ANOVA|||RV ESV|
1616181|NCT02442206|2966848|Superiority||Mean Difference (Net)|2.241||||0.0437|2-Sided|95.0|0.066|4.417|||ANOVA|||LV ESV|
1616182|NCT02442206|2966849|Superiority||Mean Difference (Net)|1.131||||0.1732|2-Sided|95.0|-0.512|2.774|||ANOVA|||RV EF|
1616183|NCT02442206|2966849|Superiority||Mean Difference (Net)|1.209||||0.142|2-Sided|95.0|-0.419|2.836|||ANOVA|||LV EF|
1616184|NCT02442206|2966850|Superiority||Mean Difference (Net)|-0.625|||<|0.0001|2-Sided|95.0|-0.761|-0.489|||ANOVA||||
1616185|NCT02442206|2966851|Superiority||Mean Difference (Net)|-1.639|||<|0.0001|2-Sided|95.0|-1.945|-1.332|||ANOVA||||
1616186|NCT02442206|2966852|Superiority||Mean Difference (Net)|-0.751|||<|0.0001|2-Sided|95.0|-0.925|-0.577|||ANOVA||||
1616187|NCT02442206|2966853|Superiority||Mean Difference (Net)|-0.177||||0.0017|2-Sided|95.0|-0.285|-0.07|||ANOVA||||
1616188|NCT02442206|2966854|Superiority||Mean Difference (Net)|0.446|||<|0.0001|2-Sided|95.0|0.352|0.541|||ANOVA||||
1616189|NCT02442206|2966855|Superiority||Mean Difference (Net)|0.67|||<|0.0001|2-Sided|95.0|0.55|0.8|||ANOVA||||
1616190|NCT02442206|2966856|Superiority||Mean Difference (Net)|0.42|||<|0.0001|2-Sided|95.0|0.36|0.49|||ANOVA||||
1616191|NCT02442206|2966857|Superiority||Mean Difference (Net)|10.27|||<|0.0001|2-Sided|95.0|6.209|14.331|||ANOVA||||
1616192|NCT02441946|2966864|Superiority||Ratio of Geometric Means|0.25|||<|0.001|2-Sided|90.0|0.17|0.38|||t-test, 1 sided||||
1616193|NCT02441946|2966864|Superiority||Ratio of Geometric Means|0.19|||<|0.001|2-Sided|90.0|0.13|0.28|||t-test, 1 sided||||
1616194|NCT02441218|2966880|Superiority or Other (legacy)||Hazard Ratio (HR)|0.82|||<|0.0001|2-Sided|95.0|0.74|0.89|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate. P-value: Wald test||
1616195|NCT02441218|2966881|Superiority or Other (legacy)||Hazard Ratio (HR)|0.84||||0.0002|2-Sided|95.0|0.77|0.92|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"||
1616196|NCT02441218|2966882|Superiority or Other (legacy)||Hazard Ratio (HR)|0.88||||0.0013|2-Sided|95.0|0.81|0.95|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"||
1616197|NCT02441218|2966883|Superiority or Other (legacy)||Hazard Ratio (HR)|0.85||||0.0002|2-Sided|95.0|0.78|0.92|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"||
1616198|NCT02441218|2966884|Superiority or Other (legacy)||Hazard Ratio (HR)|0.89||||0.0027|2-Sided|95.0|0.82|0.96|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"||
1616199|NCT02441218|2966885|Superiority or Other (legacy)||Hazard Ratio (HR)|0.74||||0.014|2-Sided|95.0|0.58|0.94|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"||
1616200|NCT02441218|2966886|Superiority or Other (legacy)||Hazard Ratio (HR)|0.9||||0.092|2-Sided|95.0|0.8|1.02|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"||
1616201|NCT02441218|2966887|Superiority or Other (legacy)||Hazard Ratio (HR)|0.74|||<|0.0001|2-Sided|95.0|0.66|0.83|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"||
1616202|NCT02441218|2966888|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.128|2-Sided|95.0|0.8|1.03|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"||
1616203|NCT02441218|2966889|Superiority or Other (legacy)||Hazard Ratio (HR)|0.82|||<|0.0001|2-Sided|95.0|0.75|0.9|||Regression, Cox||"Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake at randomisation as a covariate.~P-value: Wald test"||
1616204|NCT02441179|2966890|Superiority or Other|||||||0.55|||||||Wilcoxon (Mann-Whitney)||||
1616205|NCT02441179|2966891|Superiority or Other|||||||0.43|||||||Wilcoxon (Mann-Whitney)||||
1616211|NCT02440789|2966904|Other|||||||0.008|||||||t-test, 2 sided|paired t-test|||
1616212|NCT02440789|2966906|Other|||||||0.69|||||||t-test, 2 sided|paired t-test|||
1616213|NCT02440789|2966908|Other|||||||0.005|||||||t-test, 2 sided|paired t-test|||
1616214|NCT02440789|2966910|Other|||||||0.031|||||||t-test, 2 sided|paired t-test|||
1616215|NCT02440789|2966912|Other|||||||0.22|||||||t-test, 2 sided|paired t-test|||
1616216|NCT02440789|2966914|Other|||||||0.65|||||||t-test, 2 sided|paired t-test|||
1616217|NCT02440789|2966916|Other|||||||0.93|||||||t-test, 2 sided|paired t-test|||
1616218|NCT02440789|2966918|Other|||||||0.77|||||||t-test, 2 sided|paired t-test|||
1616219|NCT02440789|2966920|Other|||||||0.28|||||||t-test, 2 sided|paired t-test|||
1616220|NCT02440789|2966922|Other|||||||0.7|||||||t-test, 2 sided|paired t-test|||
1616221|NCT02440789|2966924|Other|||||||0.28|||||||t-test, 2 sided|paired t-test|||
1616222|NCT02440789|2966926|Other|||||||0.72|||||||t-test, 2 sided|paired t-test|||
1616223|NCT02440789|2966928|Other|||||||0.47|||||||t-test, 2 sided|paired t-test|||
1616224|NCT02440789|2966930|Other|||||||0.7|||||||t-test, 2 sided|paired t-test|||
1616225|NCT02440789|2966932|Other|||||||0.97|||||||t-test, 2 sided|paired t-test|||
1616226|NCT02440789|2966934|Other|||||||0.75|||||||t-test, 2 sided|paired t-test|||
1616227|NCT02440789|2966936|Other|||||||0.26|||||||t-test, 2 sided|paired t-test|||
1616228|NCT02440789|2966938|Other|||||||0.008|||||||t-test, 2 sided|paired t-test|||
1616229|NCT02440789|2966941|Other|||||||0.041|||||||t-test, 2 sided|paired t-test|||
1616230|NCT02440789|2966943|Other|||||||0.93|||||||t-test, 2 sided|paired t-test; results less than the analysis lower limit (0.7 cp/mL) were imputed to a value of one half the analysis lower limit.|||
1616231|NCT02440789|2966945|Other|||||||0.11|||||||t-test, 2 sided|paired t-test|||
1616232|NCT02440789|2966947|Other|||||||0.56|||||||t-test, 2 sided|paired t-test|||
1616233|NCT02440022|2966973|Other|||||||0.716||||||P-value was type 3 test of the interaction of treatment group and pre-dilation balloon type.|Regression, Cox||||
1616234|NCT02440022|2966979|Non-Inferiority|Where δ = 10% is the non-inferiority margin, which is the range of difference that is considered not clinically important. A non-inferiority Farrington and Manning Test was used to test the primary safety hypothesis. The test is successful if the one-sided p-value is less than 0.025. In addition to the p-value of the test, the confidence intervals of the rate in each group and the difference between the two groups is calculated.||||||0.002|||||||Binary Analysis|||"H0: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is inferior to that p2 of the PTA treatment group. (i.e. p1 ≤ p2 - δ)~H1: The primary safety rate p1 in the DCB treatment group through 30 days post index procedure is non-inferior to that p2 of the PTA treatment group. (i.e. p1 > p2 - δ)"|
1616235|NCT02440022|2966980|Superiority|||||||0.0562|||||||Kaplan-Meier||||
1616236|NCT02439879|2966981|Superiority or Other||||||<|0.05|||||||paired t test|||All data were analyzed using the SPSS v16 statistical package software. To compare categorical variables, the chi2 test was used, and, for continuous variables,the T-test for independent or paired samples was applied.Data are expressed as percent values with 95% confidence intervals (CI) or mean ± SD or mean ± SEM|
1616237|NCT02439320|2966988|Superiority||Odds Ratio (OR)|1.7|||<|0.001|2-Sided|95.0|1.4|2.2|||Regression, Logistic||||
1616238|NCT02439320|2966988|Superiority||Odds Ratio (OR)|1.9|||<|0.001|2-Sided|95.0|1.5|2.4|||Regression, Logistic||||
1616239|NCT02439320|2966989|Superiority||Odds Ratio (OR)|1.3||||0.037|2-Sided|95.0|1.0|1.6|||Regression, Logistic||||
1616240|NCT02439320|2966989|Superiority||Odds Ratio (OR)|1.4||||0.006|2-Sided|95.0|1.1|1.8|||Regression, Logistic||||
1616241|NCT02439320|2966990|Superiority||Odds Ratio (OR)|1.1||||0.47|2-Sided|95.0|0.9|1.4|||Regression, Linear||||
1616242|NCT02439320|2966990|Superiority||Odds Ratio (OR)|1.1||||0.386|2-Sided|95.0|0.9|1.4|||Regression, Linear||||
1616243|NCT02439320|2966992|Superiority||Odds Ratio (OR)|0.6||||0.035|2-Sided|95.0|0.4|1.0|||Regression, Logistic||||
1616244|NCT02439320|2966992|Superiority||Odds Ratio, log|0.7||||0.12|2-Sided|95.0|0.5|1.1|||Regression, Logistic||||
1616245|NCT02439320|2966993|Superiority||Odds Ratio (OR)|0.3|||<|0.001|2-Sided|95.0|0.2|0.4|||Regression, Logistic||||
1616246|NCT02439320|2966993|Superiority||Odds Ratio (OR)|0.4|||<|0.001|2-Sided|95.0|0.3|0.5|||Regression, Logistic||||
1616247|NCT02439320|2966994|Superiority||Odds Ratio (OR)|2.1|||=|0|2-Sided|95.0|1.3|3.4|||Regression, Logistic||||
1616248|NCT02439320|2966994|Superiority||Odds Ratio (OR)|1.7|||=|0|2-Sided|95.0|1.1|2.8|||Regression, Logistic||||
1616249|NCT02439320|2966995|Superiority||Odds Ratio (OR)|2.5|||<|0.001|2-Sided|95.0|1.9|3.3|||Regression, Logistic||||
1616250|NCT02439320|2966995|Superiority||Odds Ratio, log|2.4|||<|0.001|2-Sided|95.0|1.8|3.1|||Regression, Logistic||||
1616251|NCT02439320|2966996|Superiority||Odds Ratio, log|1.6|||<|0.001|2-Sided|95.0|1.3|2.1|||Regression, Logistic||||
1616252|NCT02439320|2966996|Superiority||Odds Ratio (OR)|1.7|||<|0.001|2-Sided|95.0|1.3|2.2|||Regression, Logistic||||
1616253|NCT02439320|2966997|Superiority||Odds Ratio (OR)|2.6|||<|0.001|2-Sided|95.0|2.0|3.6|||Regression, Logistic||||
1616254|NCT02439320|2966997|Superiority||Odds Ratio (OR)|2.2|||<|0.001|2-Sided|95.0|1.6|3.0|||Regression, Logistic||||
1616255|NCT02439281|2966998|Other|||||||0.5692|||||||Wilcoxon (Mann-Whitney)||||
1616256|NCT02439281|2966999|Other|||||||0.778|||||||Wilcoxon (Mann-Whitney)||||
1616257|NCT02439281|2967000|Other|||||||0.9531|||||||Wilcoxon (Mann-Whitney)||||
1616258|NCT02439281|2967003|Other|||||||0.8914|||||||Wilcoxon (Mann-Whitney)||||
1616259|NCT02439281|2967004|Other|||||||0.451|||||||Wilcoxon (Mann-Whitney)||||
1616329|NCT02436577|2967290|Superiority or Other||Geometric mean ratio|95.15|||||2-Sided|90.0|91.59|98.85||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.|
1616260|NCT02439164|2967009|Superiority||Mean Difference (Net)|23.51|||<|0.01|2-Sided|95.0|14.16|32.87|||t-test, 2 sided|bonferroni correction was used for post hoc analysis, P value less than 0.05 indicated statistical significance.|this described the difference during midazolam sedation between the glioma and control group without dividing into subgroups.||Oneway Analysis of Variance (ANOVA) was used to test the difference among hands in a certain time point. General linear model for repeated measures ANOVA was used to analyze the time difference of test before and after drug administration,
1616261|NCT02438826|2967025|Superiority||Odds Ratio (OR)|0.788||||0.437|2-Sided|95.0|0.431|1.44|||Mixed Models Analysis||||
1616262|NCT02438826|2967026|Superiority||Odds Ratio (OR)|1.008||||0.979|2-Sided|95.0|0.548|1.856|||Mixed Models Analysis||||
1616263|NCT02438826|2967027|Superiority||Odds Ratio (OR)|1.141||||0.713|2-Sided|95.0|0.563|2.314|||Mixed Models Analysis||||
1616264|NCT02438826|2967028|Superiority||Odds Ratio (OR)|1.51||||0.057|2-Sided|95.0|0.987|2.309|||Mixed Models Analysis||||
1616265|NCT02438826|2967029|Superiority|||||||0.946||||||Chui, Hung, Wang (CHW) procedure applied)|Mixed Models Analysis||||
1616266|NCT02438826|2967030|Superiority||Odds Ratio (OR)|1.297||||0.17|2-Sided|95.0|0.83|2.028||Cui, Hung, Wang (CHW) procedure applied|Mixed Models Analysis||||
1616267|NCT02438826|2967031|Superiority||LSMean Difference|-0.8||||0.334|2-Sided|95.0|-2.77|1.17||Cui, Hung, Wang (CHW) procedure applied|Mixed Models Analysis||||
1616268|NCT02438540|2967050|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616269|NCT02438540|2967051|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616270|NCT02438540|2967052|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616271|NCT02438540|2967053|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616272|NCT02438540|2967054|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616273|NCT02438540|2967055|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616274|NCT02438540|2967056|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616275|NCT02438540|2967057|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616276|NCT02438540|2967058|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616277|NCT02438540|2967059|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616278|NCT02438540|2967060|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616279|NCT02438540|2967061|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616280|NCT02438540|2967062|Non-Inferiority or Equivalence|from 0.59±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082||||||0.082||||||CRP is known to be an independent parameter|ANOVA||||
1616281|NCT02438540|2967062|Non-Inferiority or Equivalence|from 0.60±0.03 mg/dl before treatment to 0.57±0.03 mg/dl after treatment, P=0.082||||||0.082||||||CRP is known to be an independent parameter|ANOVA||||
1616282|NCT02438540|2967062|Non-Inferiority or Equivalence|multiple comparatives||||||0.082||||||CRP is known to be an independent parameter|ANOVA||||
1616283|NCT02438540|2967063|Superiority or Other|||||||0.04|||||||ANOVA||||
1616284|NCT02438540|2967064|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616285|NCT02438540|2967065|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616286|NCT02438540|2967066|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616287|NCT02438540|2967067|Superiority or Other||||||<|0.001|||||||ANOVA||||
1616288|NCT02438384|2967077|Superiority||Mean Difference (Final Values)|1.1|||||2-Sided|95.0|0.6|1.6|||||||
1616289|NCT02438384|2967077|Superiority||Mean Difference (Final Values)|1.7|||||2-Sided|95.0|1.2|2.1|||||||
1616290|NCT02438137|2967081|Superiority|In multiple linear regression models, the effect of DMF treatment on mean RDI change (beta-coefficient) was -11.3 respiratory events per hour (p=0.0124).|beta-coefficient for treatment effect|-11.3|Standard Error of the Mean|4.3||0.0124|2-Sided||||||Regression, Linear|||Multiple linear regression models were used to calculate treatment effect (DMF or placebo) on mean RDI change, controlling for change in age, gender, BMI, time spent in supine sleep, and time spent in REM sleep.|A mixed effects model, which treated RDI as a repeated measure and used individual ID as random effect, adjusted for age, gender, BMI, time spent in supine sleep, was also conducted. In this model, the effect of DMF compared to placebo, controlling for all other covariates, is a 28% decrease in Month 4 RDI (p=0.033).
1616291|NCT02437890|2967127|Superiority||||||=|0||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: 2nd Beta model"|
1616292|NCT02437890|2967127|Superiority||||||=|0||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: 1st Beta model"|
1616293|NCT02437890|2967127|Superiority||||||=|0||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: logistic model"|
1616294|NCT02437890|2967127|Superiority||||||=|0||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: Emax model"|
1616388|NCT02434471|2967477|Other||Mean Difference (Final Values)|0.1||||0.83|2-Sided||||||Mixed Models Analysis||||
1617133|NCT02420353|2968683|Other|mixed effects model||||||0.5853|||||||Mixed Models Analysis||||
1616295|NCT02437890|2967127|Superiority||||||=|0||||||Threshold for statistical significance: p = 0.05|Multiple Contrast Test|||"A multiple contrast test was used to establish evidence of a drug effect by testing for a statistically significant dose-response signal for clinical endpoint and patient population investigated in the study. Candidate dose-response models were selected amongst the following types of parametric models: linear model, Emax model, logistic model, a 1st Beta model, and a 2nd Beta model.~Model tested: linear model"|
1616296|NCT02437487|2967144|Superiority||Relative Risk|1.0878|||||2-Sided|95.0|0.7383|1.6029|||||||
1616297|NCT02437487|2967145|Superiority||Relative Risk|1.2217|||||2-Sided|95.0|0.7919|1.8849|||||||
1616298|NCT02437487|2967146|Superiority||Relative Risk|1.2624|||||2-Sided|95.0|0.7668|2.0785|||||||
1616299|NCT02437487|2967148|Superiority||Relative Risk|1.2217|||||2-Sided|95.0|0.7919|1.8849|||||||
1616300|NCT02437383|2967189|Superiority||LSM Difference (Final Values)|-1.8||||0.414|2-Sided|95.0|-6.2|2.6||P-value is not adjusted for multiple comparisons and the a priori threshold for statistical significance is 0.05.|Mixed Models Analysis|Covariates for site, baseline value, sex, race, treatment, visit, a treatment*visit interaction, and an unstructured covariance structure.|||
1616301|NCT02437318|2967204|Superiority||Hazard Ratio (HR)|0.65||||0.00065|2-Sided|95.0|0.5|0.85||(one-sided)|Log Rank||||
1616302|NCT02437305|2967205|Superiority or Other||||||>|0.5||||||P-value compares the increase in knowledge from pre-intervention to 2-months follow-up between the 2 groups.|McNemar||||
1616303|NCT02437305|2967206|Superiority or Other|||||||0.048||||||P-value compares the increase in skin self-exams from pre-intervention to 2-months follow-up between the 2 groups.|McNemar||||
1616304|NCT02437162|2967252|Superiority||Percentage difference|-0.646||||0.913|2-Sided|95.0|-12.18|10.887|||Cochran-Mantel-Haenszel||||
1616305|NCT02437162|2967252|Superiority||Percentage difference|2.586||||0.669|2-Sided|95.0|-9.138|14.31|||Cochran-Mantel-Haenszel||||
1616306|NCT02436915|2967253|Equivalence|We hypothesized that the real tDCS would improve the performance of walking (i.e., greater percent decrease of dual task cost to stride time from baseline to follow ups) as compared to the sham tDCS.||||||0.04|||||||ANOVA||||
1616307|NCT02436915|2967254|Equivalence|We hypothesized that the real tDCS would improve the performance of dual task standing (i.e., greater percent decrease of dual task cost to standing postural sway area from baseline to follow ups) as compared to the sham tDCS.||||||0.0007|||||||ANOVA||||
1616308|NCT02436915|2967255|Equivalence|We hypothesized that the real tDCS would improve the performance of TMT (i.e., greater percent decrease of time to complete TMT from baseline to follow ups) as compared to the sham tDCS.||||||0.54|||||||ANOVA||||
1616309|NCT02436915|2967256|Equivalence|We hypothesized that the real tDCS would reduce the depression (i.e., greater percent decrease of GDS score from baseline to follow ups) as compared to the sham tDCS.||||||0.37|||||||ANOVA||||
1616310|NCT02436915|2967257|Equivalence|We hypothesized that the real tDCS would improve the performance of dual task standing (i.e., greater percent decrease of dual task cost to standing sway speed from baseline to follow ups) as compared to the sham tDCS.||||||0.004|||||||ANOVA||||
1616311|NCT02436915|2967258|Equivalence|We hypothesized that the real tDCS would improve the dual task performance of walking (i.e., greater percent decrease of dual task cost to walking speed from baseline to follow ups) as compared to the sham tDCS.||||||0.37|||||||ANOVA||||
1616312|NCT02436915|2967259|Equivalence|We hypothesized that the real tDCS would improve the MoCA score (i.e., greater percent increase decrease of MoCA score from baseline to follow ups) as compared to the sham tDCS.||||||0.03|||||||ANOVA||||
1616313|NCT02436915|2967260|Equivalence|We hypothesized that the real tDCS would improve the performance of TUG (i.e., greater percent decrease of time to complete TUG from baseline to follow ups) as compared to the sham tDCS.||||||0.24|||||||ANOVA||||
1616314|NCT02436889|2967261|Superiority||Mean Difference (Final Values)|2.1||||0.0101|2-Sided|95.0|0.5|3.71|||ANCOVA||||
1616315|NCT02436889|2967262|Superiority||Mean Difference (Final Values)|1.87||||0.0168|2-Sided|95.0|0.34|3.4|||ANCOVA||||
1616316|NCT02436889|2967263|Superiority||Mean Difference (Final Values)|-0.63||||0.1956|2-Sided|95.0|-1.59|0.33|||ANCOVA||||
1616317|NCT02436889|2967264|Superiority||Mean Difference (Final Values)|-12.01||||0.0001|2-Sided|95.0|-18.16|-5.87|||ANCOVA||||
1616318|NCT02436889|2967265|Superiority||Mean Difference (Final Values)|3.11||||0.2415|2-Sided|95.0|-2.09|8.31|||ANCOVA|change from baseline, adjusted for baseline value|||
1616319|NCT02436889|2967266|Superiority|||||||0.949|||||||ANCOVA||||
1616320|NCT02436811|2967267|Superiority or Other||||||<|0.001||||||A stepwise forward selection model was used. All independent variables with P<0.20 in the univariate analysis were selected and those which were significant (P<0.05) were kept in the final model. The level of significance was 5%.|Regression, Poisson|||Univariate and multivariate Poisson regressions with robust variance were obtained to estimate the rate ratios (RR) and their respective 95% confidence intervals. Two Poisson regression models were generated, using the knowledge score 15 minutes after the intervention (post-test) and 4 weeks after the interventions (follow-up test) as dependent variables.|
1616321|NCT02436681|2967268|Superiority||||||=|0|||||||t-test, 1 sided||||
1616322|NCT02436681|2967269|Superiority||||||=|0|||||||t-test, 1 sided||||
1616323|NCT02436681|2967271|Superiority||||||=|0|||||||t-test, 1 sided||||
1616324|NCT02436681|2967273|Superiority||||||<|0.0001|||||||t-test, 1 sided||||
1616325|NCT02436577|2967289|Superiority or Other||Geometric mean ratio|95.47|||||2-Sided|90.0|91.99|99.08||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.|
1616326|NCT02436577|2967289|Superiority or Other||Geometric mean ratio|98.46|||||2-Sided|90.0|94.85|102.2||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.|
1616327|NCT02436577|2967289|Superiority or Other||Geometric mean ratio|96.5|||||2-Sided|90.0|93.31|99.8||||||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.|
1616328|NCT02436577|2967289|Superiority or Other||Geometric Mean Ratio|97.75|||||2-Sided|90.0|94.4|101.21||||||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.|
1616330|NCT02436577|2967290|Superiority or Other||Geometric mean ratio|98.43|||||2-Sided|90.0|94.75|102.25||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered compared to ticagrelor IR tablets.|
1616331|NCT02436577|2967290|Superiority or Other||Geometric Mean ratio|96.38|||||2-Sided|90.0|93.24|99.63||||||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.|
1616332|NCT02436577|2967290|Superiority or Other||Geometric Mean Ratio|97.76|||||2-Sided|90.0|94.46|101.18||||||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.|
1616333|NCT02436577|2967291|Superiority or Other||Geometric mean ratio|92.32|||||2-Sided|90.0|85.04|100.23||||||Statistical Assessment of Bioequivalence for metabolite AR-C124910XX Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.|
1616334|NCT02436577|2967291|Superiority or Other||Geometric mean ratio|96.79|||||2-Sided|90.0|88.27|106.14||||||Statistical Assessment of Bioequivalence for metabolite AR-C124910XX Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.|
1616335|NCT02436577|2967291|Superiority or Other||Geometric mean ratio|93.67|||||2-Sided|90.0|87.88|99.84||||||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.|
1616336|NCT02436577|2967291|Superiority or Other||Geometric Mean Ratio|93.16|||||2-Sided|90.0|85.8|101.15||||||Statistical Assessment of Bioequivalence for Ticagrelor Following Ticagrelor OD Tablets Compared to Ticagrelor IR Tablets.|
1616337|NCT02436330|2967292|Superiority or Other|||||||0.4892|||||||t-test, 2 sided||||
1616338|NCT02436330|2967293|Superiority or Other|||||||0.3671|||||||t-test, 2 sided||||
1616339|NCT02436330|2967294|Superiority or Other||Mean Difference (Net)|3.61||||0.1265|2-Sided|95.0|-1.15|8.33|||t-test, 2 sided||||
1616340|NCT02436330|2967295|Superiority or Other|||||||0.2122|||||||t-test, 2 sided||||
1616341|NCT02436330|2967297|Superiority or Other||Mean Difference (Net)|0.7024||||0.6974|2-Sided|95.0|-2.9377|4.3425|||t-test, 2 sided||||
1616342|NCT02436330|2967298|Superiority or Other||Mean Difference (Net)|-0.7958||||0.0008|2-Sided|95.0|-1.235|-0.3566|||t-test, 2 sided||||
1616343|NCT02436330|2967299|Superiority or Other||Mean Difference (Net)|-0.8169||||0.2764|2-Sided|95.0|-2.4147|0.7808|||t-test, 2 sided||||
1616344|NCT02436330|2967300|Superiority or Other||Mean Difference (Net)|7.2151||||0.0247|2-Sided|95.0|0.973|13.457|||t-test, 2 sided||||
1616345|NCT02436330|2967301|Superiority or Other||Mean Difference (Net)|-4.2048||||0.176|2-Sided|95.0|-10.3835|1.974|||t-test, 2 sided||||
1616346|NCT02436330|2967302|Superiority or Other||Mean Difference (Net)|-247.9||||0.0849|2-Sided|95.0|-531.7|35.8686|||t-test, 2 sided||||
1616347|NCT02436330|2967303|Superiority or Other||Mean Difference (Net)|0.2995||||0.1856|2-Sided|95.0|-0.2051|0.8041|||t-test, 2 sided||||
1616348|NCT02436330|2967304|Superiority or Other||Mean Difference (Net)|0.2837||||0.3326|2-Sided|95.0|-0.3037|0.8711|||t-test, 2 sided||||
1616349|NCT02436330|2967305|Superiority or Other||Mean Difference (Net)|2433.7||||0.812|2-Sided|95.0|-18579.7|23447.2|||t-test, 2 sided||||
1616350|NCT02436330|2967306|Superiority or Other||Mean Difference (Net)|-1.0491||||0.4164|2-Sided|95.0|-3.6407|1.5425|||t-test, 2 sided||||
1616351|NCT02436330|2967307|Superiority or Other||Mean Difference (Net)|-0.9464||||0.2207|2-Sided|95.0|-2.4954|0.6025|||t-test, 2 sided||||
1616352|NCT02436330|2967308|Superiority or Other||Mean Difference (Net)|0.2971||||0.035|2-Sided|95.0|0.0224|0.5718|||t-test, 2 sided||||
1616353|NCT02436330|2967309|Superiority or Other||Mean Difference (Net)|-2.9||||0.501|2-Sided|95.0|-11.7|5.8|||t-test, 2 sided||||
1616354|NCT02436330|2967310|Superiority or Other||Mean Difference (Net)|1.0||||0.851|2-Sided|95.0|-9.0|11.0|||t-test, 2 sided||||
1616355|NCT02436330|2967311|Superiority or Other||Mean Difference (Net)|0.0||||0.991|2-Sided|95.0|-5.2|5.1|||t-test, 2 sided||||
1616356|NCT02436330|2967312|Superiority or Other||Mean Difference (Net)|-0.0775||||0.0335|2-Sided|95.0|-0.1485|-0.00652|||t-test, 2 sided||||
1616357|NCT02436330|2967313|Superiority or Other||Mean Difference (Net)|-0.0615||||0.0967|2-Sided|95.0|-0.1344|0.0115||We checked the distribution of bmiz changes between baseline and 6 months, and there is one subject from control group had bigger changes than others. After excluding this subject, the results are still similar with previous.|t-test, 2 sided||||
1616358|NCT02436031|2967331|Other|||||||0.135|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Passive Pcrit|
1616359|NCT02436031|2967331|Other|||||||0.049|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Active Pcrit|
1616360|NCT02435433|2967385|Superiority||Hazard Ratio (HR)|0.799||||0.2382|2-Sided|95.0|0.545|1.171|||Log Rank||||
1616361|NCT02435433|2967389|Superiority||Odds Ratio (OR)|4.6||||0.1697|2-Sided|95.0|0.6|37.3|||Cochran-Mantel-Haenszel||||
1616362|NCT02435433|2967390|Superiority||Hazard Ratio (HR)|0.427|||<|0.0001|2-Sided|95.0|0.313|0.582|||Log Rank||||
1616363|NCT02435433|2967391|Superiority||Hazard Ratio (HR)|0.452|||<|0.0001|2-Sided|95.0|0.339|0.603|||Log Rank||||
1616364|NCT02435433|2967392|Superiority||Hazard Ratio (HR)|0.71||||0.0199|2-Sided|95.0|0.531|0.949|||Log Rank||||
1616365|NCT02435277|2967393|Other|||||||0.0317|||||||ANCOVA||||
1616366|NCT02435277|2967393|Other|||||||0.0083|||||||ANCOVA||||
1616367|NCT02435277|2967393|Other|||||||0.26||||||Total daily dose is twice the respective dose Pairwise Comparison using Treatment D as the Reference Group|ANCOVA|||Mixed Model Inferential Statistical Analysis of Fssting Plasma Glucose change from day 1-day 84 in Evaluable Population (n=43)|
1616368|NCT02435277|2967394|Other|||||||0.0458|||||||ANCOVA||||
1616369|NCT02435277|2967394|Other|||||||0.0912|||||||ANCOVA||||
1616370|NCT02435277|2967394|Other|||||||0.0475||||||Total daily dose is twice the respective dose, Pairwise Comparison using Control as the Reference Group|ANCOVA|||Mixed Model Inferential Statistical Analysis of HbA1c change from day 1-day 84 Evaluable Population (n=43)|
1616371|NCT02435069|2967398|Superiority|||||||0.346594|||||||two-sample pooled variance t test|two tailed||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.|
1616389|NCT02434471|2967478|Other||Mean Difference (Final Values)|0.6|||<|0.001|2-Sided||||||Mixed Models Analysis||||
1616372|NCT02435069|2967399|Superiority|||||||0.8028|||||||two-sample pooled variance t-test|two-sided||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the difference in calprotectin levels between samples obtained at baseline and samples obtained following the completion of the NS and USP Glycerin flush in the dosing phase of the study.|
1616373|NCT02435069|2967402|Superiority|||||||0.172|||||||two-sample pooled variance t-test|two tailed||Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.|
1616374|NCT02435069|2967403|Superiority|||||||0.069751||||||significance level set at <0.05 a priori|two-sample pooled variance t-test|Two-tailed||"Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. and calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.~Power analysis conducted using data from this study with α = 0.5, power of .80, correlation between two means of .598, and effect size of 1.554 estimated a sample size of 11 would be needed to minimize the risk of a Type II error to (20%)."|
1616375|NCT02434939|2967405|Non-Inferiority or Equivalence|A clinically meaningful difference in validated pain scores was defined as 1.3.Assuming both treatments are on average equal, a sample size of 240 patients (120 per group) provided 95% power to demonstrate that IV LDK is non-inferior to IV morphine with a 0.05 level of significance.||||||0.07|||||||t-test, 2 sided||||
1616376|NCT02434939|2967408|Non-Inferiority or Equivalence|a clinically significant difference in validated pain scores was defined as 1.3. assuming both treatments are on average equal, 240 patients provided 95% power to demonstrate that IV low dose ketamine is non inferior to IV morphine with a 0.05 level of significance.|Mean Difference (Final Values)|5.5||||0.18|2-Sided|95.0|-2.2|13.2|||t-test, 2 sided||||
1616377|NCT02434770|2967409|Non-Inferiority|To show non-inferiority of Lots 1+2 combined versus BioFarma bOPV Control, the lower limit of the 95% CI must be > 0.5.|Ratio of Geometric Mean Titers|0.99|||||2-Sided|95.0|0.71|1.38|||||Lot 1 + Lot 2 / BioFarma bOPV||
1616378|NCT02434770|2967410|Other||Difference in seroprotection rate|-0.09||||0.5586|2-Sided|95.0|-3.86|4.48|||Fisher’s exact 1-tailed test|Fisher’s exact 1-tailed test of a lower rate in Lots 1+2|BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV||
1616379|NCT02434770|2967411|Non-Inferiority|To show non-inferiority of Lots 1+2 combined versus BioFarma bOPV Control, the lower limit of the 95% CI must be > 0.5.|Ratio of Geometric Mean Titers|1.2|||||2-Sided|95.0|0.89|1.63|||||Lot 1 + Lot 2 / BioFarma bOPV||
1616380|NCT02434770|2967412|Non-Inferiority|Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes.|Difference in seroconversion rate|0.1|||||2-Sided|95.0|-2.6|2.8|||||Lot 1 - Lot 2|For Serotype 3|
1616381|NCT02434770|2967412|Other|Secondary efficacy objective 1 of this study was to show consistency of the two lots in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The two lots would be declared consistent if the upper and lower limits of the 95% CI for the difference in seroconversion rates is within 10 percentage points of the observed difference for both serotypes.|Difference in seroconversion rate|-0.4|||||2-Sided|95.0|-3.0|2.1|||||Lot 1 - Lot 2|For Serotype 1|
1616382|NCT02434770|2967412|Non-Inferiority|Primary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The immune response of the combined lots of BBIBP bOPV would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the difference in percent responders is greater than negative 10, provided the two lots are declared equivalent.|Difference in seroconversion rate|2.2|||||2-Sided|95.0|-0.1|5.6|||||BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|For Serotype 3|
1616383|NCT02434770|2967412|Non-Inferiority|Primary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody seroconversion rates. The immune response of the combined lots of BBIBP bOPV would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the difference in percent responders is greater than negative 10, provided the two lots are declared equivalent.|Difference in seroconversion rate|1.5|||||2-Sided|95.0|-0.5|4.6|||||BBIBP bOPV (Lot 1 + Lot 2) - BioFarma bOPV|For serotype 1|
1616384|NCT02434770|2967413|Non-Inferiority|Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was > 0.5.|Ratio of Geometric Mean Titers|1.47|||||2-Sided|95.0|1.21|1.79|||||BBIBP bOPV Lot 1 + Lot 2 / BioFarma bOPV||
1616385|NCT02434770|2967413|Equivalence|Primary efficacy objective 1 of this study was to demonstrate the equivalence of two lots of BBIBP bOPV in terms of post-vaccination anti-polio neutralizing antibody GMTs. The immune response of the two lots of BBIBP bOPV would be declared equivalent if the 95% confidence interval (CI) for the serotype-specific GMT ratio for both serotypes was contained within (0.5, 2.0).|Ratio of Geometric Mean Titers|0.92|||||2-Sided|95.0|0.73|1.15|||||Lot 1 / Lot 2||
1616386|NCT02434770|2967414|Non-Inferiority|Secondary efficacy objective 2 of this study was to demonstrate the non-inferiority of the two lots of BBIBP bOPV combined to the WHO control in terms of post-vaccination anti-polio neutralizing antibody GMTs. The two Lots combined would be declared non-inferior to the WHO control if the lower limit of the 95% CI for the serotype-specific GMT ratio of BBIBP Lots 1+2 over WHO control for both serotypes was > 0.5.|Ratio of Geometric Mean Titers|1.08|||||2-Sided|95.0|0.87|1.34|||||Lot 1 + Lot 2 / BioFarma bOPV||
1616387|NCT02434770|2967414|Equivalence|Primary efficacy objective 1 of this study was to demonstrate the equivalence of two lots of BBIBP bOPV in terms of post-vaccination anti-polio neutralizing antibody GMTs. The immune response of the two lots of BBIBP bOPV would be declared equivalent if the 95% confidence interval (CI) for the serotype-specific GMT ratio for both serotypes was contained within (0.5, 2.0).|Ratio of Geometric Mean Titers|0.84|||||2-Sided|95.0|0.65|1.08|||||Lot 1 / Lot 2||
1616390|NCT02434328|2967484|Other||Difference in proportions|-14.1|||||2-Sided|95.0|-21.3|-7.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1616391|NCT02434328|2967484|Other||Difference in proportions|-2.9|||||2-Sided|95.0|-9.4|3.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1616392|NCT02434328|2967484|Other||Difference in proportions|-11.0|||||2-Sided|95.0|-18.2|-4.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1616393|NCT02434328|2967484|Other||Difference in proportions|-4.5|||||2-Sided|95.0|-11.4|2.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1616394|NCT02434328|2967484|Other||Difference in proportions|-10.4|||||2-Sided|95.0|-17.2|-3.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1616395|NCT02434328|2967484|Other||Difference in proportions|-0.8|||||2-Sided|95.0|-7.5|5.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1616396|NCT02434328|2967484|Other||Difference in proportions|-14.9|||||2-Sided|95.0|-21.4|-8.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1616397|NCT02434328|2967484|Other||Difference in proportions|0.9|||||2-Sided|95.0|-5.9|7.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1616398|NCT02434328|2967484|Other||Difference in proportions|-15.5|||||2-Sided|95.0|-21.9|-8.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1616399|NCT02434328|2967484|Other||Difference in proportions|-5.7|||||2-Sided|95.0|-12.5|1.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1616400|NCT02434328|2967484|Other||Difference in proportions|-9.4|||||2-Sided|95.0|-16.3|-2.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1616401|NCT02434328|2967484|Other||Difference in proportions|-3.0|||||2-Sided|95.0|-9.2|3.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1616402|NCT02434328|2967484|Other||Difference in proportions|-18.1|||||2-Sided|95.0|-24.9|-11.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1616403|NCT02434328|2967484|Other||Difference in proportions|3.4|||||2-Sided|95.0|-3.3|10.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1616404|NCT02434328|2967484|Other||Difference in proportions|-16.5|||||2-Sided|95.0|-23.4|-9.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1616405|NCT02434328|2967484|Other||Difference in proportions|-9.4|||||2-Sided|95.0|-15.8|-3.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1616406|NCT02434328|2967484|Other||Difference in proportions|-9.7|||||2-Sided|95.0|-16.7|-2.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1616407|NCT02434328|2967484|Other||Difference in proportions|-3.9|||||2-Sided|95.0|-10.4|2.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1616408|NCT02434328|2967484|Other||Difference in proportions|-20.0|||||2-Sided|95.0|-27.3|-13.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1616409|NCT02434328|2967484|Other||Difference in proportions|7.7|||||2-Sided|95.0|0.9|14.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1616793|NCT02429791|2968033|Other||Risk Difference (RD)|2.8|||||2-Sided|95.0|-5.3|10.8|||||PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.||
1616410|NCT02434328|2967484|Other||Difference in proportions|-15.7|||||2-Sided|95.0|-22.9|-9.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1616411|NCT02434328|2967484|Other||Difference in proportions|-8.7|||||2-Sided|95.0|-15.0|-2.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1616412|NCT02434328|2967484|Other||Difference in proportions|-9.2|||||2-Sided|95.0|-15.5|-2.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1616413|NCT02434328|2967484|Other||Difference in proportions|-6.9|||||2-Sided|95.0|-14.2|0.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1616414|NCT02434328|2967485|Other||Difference in proportions|-5.9|||||2-Sided|95.0|-11.5|-0.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1616415|NCT02434328|2967485|Other||Difference in proportions|-5.6|||||2-Sided|95.0|-11.4|0.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1616416|NCT02434328|2967485|Other||Difference in proportions|-4.8|||||2-Sided|95.0|-10.5|1.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1616417|NCT02434328|2967485|Other||Difference in proportions|-1.4|||||2-Sided|95.0|-7.0|4.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1616418|NCT02434328|2967485|Other||Difference in proportions|-6.5|||||2-Sided|95.0|-12.4|-0.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1616419|NCT02434328|2967485|Other||Difference in proportions|-5.5|||||2-Sided|95.0|-10.7|-0.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1616420|NCT02434328|2967485|Other||Difference in proportions|-6.9|||||2-Sided|95.0|-12.5|-1.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1616421|NCT02434328|2967485|Other||Difference in proportions|-5.2|||||2-Sided|95.0|-11.0|-0.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1616422|NCT02434328|2967485|Other||Difference in proportions|-5.1|||||2-Sided|95.0|-10.9|0.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1616423|NCT02434328|2967485|Other||Difference in proportions|-5.6|||||2-Sided|95.0|-10.9|-0.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1616424|NCT02434328|2967485|Other||Difference in proportions|-5.2|||||2-Sided|95.0|-11.1|0.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1616425|NCT02434328|2967485|Other||Difference in proportions|-1.8|||||2-Sided|95.0|-7.1|3.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1616426|NCT02434328|2967485|Other||Difference in proportions|-9.1|||||2-Sided|95.0|-13.8|-3.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1616427|NCT02434328|2967485|Other||Difference in proportions|0.5|||||2-Sided|95.0|-4.8|5.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1616428|NCT02434328|2967485|Other||Difference in proportions|-6.0|||||2-Sided|95.0|-11.2|-0.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1616429|NCT02434328|2967485|Other||Difference in proportions|-5.5|||||2-Sided|95.0|-10.3|-0.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1616722|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.7|Standard Error of the Mean|0.95|||2-Sided|95.0|-2.5|1.2|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64|
1616430|NCT02434328|2967485|Other||Difference in proportions|-5.3|||||2-Sided|95.0|-10.5|-0.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1616431|NCT02434328|2967485|Other||Difference in proportions|-2.1|||||2-Sided|95.0|-6.8|2.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1616432|NCT02434328|2967485|Other||Difference in proportions|-7.9|||||2-Sided|95.0|-12.6|-3.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1616433|NCT02434328|2967485|Other||Difference in proportions|1.3|||||2-Sided|95.0|-3.6|6.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1616434|NCT02434328|2967485|Other||Difference in proportions|-7.8|||||2-Sided|95.0|-13.0|-2.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1616435|NCT02434328|2967485|Other||Difference in proportions|-1.6|||||2-Sided|95.0|-6.9|3.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1616436|NCT02434328|2967485|Other||Difference in proportions|-2.6|||||2-Sided|95.0|-7.6|2.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1616437|NCT02434328|2967485|Other||Difference in proportions|-3.5|||||2-Sided|95.0|-8.9|1.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1616438|NCT02434328|2967486|Other||Difference in proportions|0.2|||||2-Sided|95.0|-4.3|4.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1616439|NCT02434328|2967486|Other||Difference in proportions|3.8|||||2-Sided|95.0|-0.1|8.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1616440|NCT02434328|2967486|Other||Difference in proportions|-0.1|||||2-Sided|95.0|-4.5|3.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1616441|NCT02434328|2967486|Other||Difference in proportions|0.9|||||2-Sided|95.0|-3.3|5.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1616442|NCT02434328|2967486|Other||Difference in proportions|-0.3|||||2-Sided|95.0|-4.8|4.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1616443|NCT02434328|2967486|Other||Difference in proportions|0.4|||||2-Sided|95.0|-3.5|4.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1616444|NCT02434328|2967486|Other||Difference in proportions|0.2|||||2-Sided|95.0|-4.2|4.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1616445|NCT02434328|2967486|Other||Difference in proportions|2.6|||||2-Sided|95.0|-1.2|6.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1616446|NCT02434328|2967486|Other||Difference in proportions|-1.8|||||2-Sided|95.0|-6.2|2.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1616447|NCT02434328|2967486|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-4.4|3.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1616448|NCT02434328|2967486|Other||Difference in proportions|-1.2|||||2-Sided|95.0|-5.9|3.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1616449|NCT02434328|2967486|Other||Difference in proportions|1.2|||||2-Sided|95.0|-2.5|5.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1616723|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.8|Standard Error of the Mean|0.93|||2-Sided|95.0|-2.7|1.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60|
1616450|NCT02434328|2967486|Other||Difference in proportions|-2.0|||||2-Sided|95.0|-6.2|2.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1616451|NCT02434328|2967486|Other||Difference in proportions|3.8|||||2-Sided|95.0|-0.5|8.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1616452|NCT02434328|2967486|Other||Difference in proportions|-1.3|||||2-Sided|95.0|-6.0|3.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1616453|NCT02434328|2967486|Other||Difference in proportions|-1.8|||||2-Sided|95.0|-5.6|1.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1616454|NCT02434328|2967486|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-5.5|4.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1616455|NCT02434328|2967486|Other||Difference in proportions|2.8|||||2-Sided|95.0|-1.0|6.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1616456|NCT02434328|2967486|Other||Difference in proportions|-3.2|||||2-Sided|95.0|-7.9|1.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1616457|NCT02434328|2967486|Other||Difference in proportions|8.2|||||2-Sided|95.0|3.9|12.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1616458|NCT02434328|2967486|Other||Difference in proportions|0.1|||||2-Sided|95.0|-4.5|4.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1616459|NCT02434328|2967486|Other||Difference in proportions|-1.4|||||2-Sided|95.0|-5.3|2.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1616460|NCT02434328|2967486|Other||Difference in proportions|-2.1|||||2-Sided|95.0|-6.1|1.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1616461|NCT02434328|2967486|Other||Difference in proportions|1.5|||||2-Sided|95.0|-2.5|5.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1616462|NCT02434328|2967487|Other||Difference in proportions|-14.5|||||2-Sided|95.0|-20.3|-8.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1616463|NCT02434328|2967487|Other||Difference in proportions|-5.5|||||2-Sided|95.0|-11.4|0.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1616464|NCT02434328|2967487|Other||Difference in proportions|-12.0|||||2-Sided|95.0|-18.9|-5.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1616465|NCT02434328|2967487|Other||Difference in proportions|-5.3|||||2-Sided|95.0|-11.3|0.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1616466|NCT02434328|2967487|Other||Difference in proportions|-11.0|||||2-Sided|95.0|-17.4|-5.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1616467|NCT02434328|2967487|Other||Difference in proportions|-1.1|||||2-Sided|95.0|-7.0|5.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1616468|NCT02434328|2967487|Other||Difference in proportions|-16.6|||||2-Sided|95.0|-22.6|-10.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1616469|NCT02434328|2967487|Other||Difference in proportions|0.1|||||2-Sided|95.0|-6.1|6.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1616492|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-4.6|Standard Error of the Mean|5.24|||2-Sided|95.0|-14.8|5.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72|
1616470|NCT02434328|2967487|Other||Difference in proportions|-15.1|||||2-Sided|95.0|-21.3|-8.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1616471|NCT02434328|2967487|Other||Difference in proportions|-3.9|||||2-Sided|95.0|-9.8|2.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1616472|NCT02434328|2967487|Other||Difference in proportions|-9.0|||||2-Sided|95.0|-15.7|-2.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1616473|NCT02434328|2967487|Other||Difference in proportions|-2.7|||||2-Sided|95.0|-8.5|3.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1616474|NCT02434328|2967487|Other||Difference in proportions|-15.9|||||2-Sided|95.0|-22.4|-10.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1616475|NCT02434328|2967487|Other||Difference in proportions|2.5|||||2-Sided|95.0|-3.2|8.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1616476|NCT02434328|2967487|Other||Difference in proportions|-15.4|||||2-Sided|95.0|-21.5|-9.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1616477|NCT02434328|2967487|Other||Difference in proportions|-8.0|||||2-Sided|95.0|-13.6|-2.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1616478|NCT02434328|2967487|Other||Difference in proportions|-9.8|||||2-Sided|95.0|-16.5|-3.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1616479|NCT02434328|2967487|Other||Difference in proportions|-5.9|||||2-Sided|95.0|-11.6|-0.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1616480|NCT02434328|2967487|Other||Difference in proportions|-19.2|||||2-Sided|95.0|-25.5|-13.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1616481|NCT02434328|2967487|Other||Difference in proportions|3.1|||||2-Sided|95.0|-2.9|9.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1616482|NCT02434328|2967487|Other||Difference in proportions|-14.2|||||2-Sided|95.0|-20.8|-8.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1616483|NCT02434328|2967487|Other||Difference in proportions|-6.9|||||2-Sided|95.0|-12.2|-1.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1616484|NCT02434328|2967487|Other||Difference in proportions|-8.5|||||2-Sided|95.0|-13.8|-3.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1616485|NCT02434328|2967487|Other||Difference in proportions|-6.6|||||2-Sided|95.0|-13.2|-0.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1616486|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-3.0|Standard Error of the Mean|5.42|||2-Sided|95.0|-13.6|7.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96|
1616487|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-2.3|Standard Error of the Mean|5.25|||2-Sided|95.0|-12.6|8.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92|
1616488|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-4.0|Standard Error of the Mean|5.39|||2-Sided|95.0|-14.6|6.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88|
1616489|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-3.1|Standard Error of the Mean|5.3|||2-Sided|95.0|-13.5|7.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84|
1616490|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-3.7|Standard Error of the Mean|5.33|||2-Sided|95.0|-14.1|6.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80|
1616491|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-2.8|Standard Error of the Mean|5.23|||2-Sided|95.0|-13.1|7.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76|
1616493|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-0.6|Standard Error of the Mean|5.17|||2-Sided|95.0|-10.7|9.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68|
1616494|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-3.9|Standard Error of the Mean|5.24|||2-Sided|95.0|-14.2|6.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64|
1616495|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-4.2|Standard Error of the Mean|5.15|||2-Sided|95.0|-14.3|5.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60|
1616496|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-5.0|Standard Error of the Mean|5.31|||2-Sided|95.0|-15.4|5.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56|
1616497|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-2.7|Standard Error of the Mean|5.19|||2-Sided|95.0|-12.9|7.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52|
1616498|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-7.0|Standard Error of the Mean|5.4|||2-Sided|95.0|-17.6|3.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48|
1616499|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-2.8|Standard Error of the Mean|5.42|||2-Sided|95.0|-13.4|7.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44|
1616500|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-6.6|Standard Error of the Mean|5.3|||2-Sided|95.0|-17.0|3.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40|
1616501|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-5.0|Standard Error of the Mean|5.15|||2-Sided|95.0|-15.2|5.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36|
1616502|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-2.0|Standard Error of the Mean|5.37|||2-Sided|95.0|-12.6|8.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32|
1616503|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-3.1|Standard Error of the Mean|5.13|||2-Sided|95.0|-13.1|7.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28|
1616504|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-5.8|Standard Error of the Mean|5.35|||2-Sided|95.0|-16.3|4.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24|
1616505|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|4.6|Standard Error of the Mean|5.11|||2-Sided|95.0|-5.5|14.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20|
1616506|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-3.7|Standard Error of the Mean|5.12|||2-Sided|95.0|-13.7|6.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16|
1616507|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-4.5|Standard Error of the Mean|4.98|||2-Sided|95.0|-14.3|5.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12|
1616508|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-3.8|Standard Error of the Mean|4.98|||2-Sided|95.0|-13.6|6.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8|
1616509|NCT02434328|2967488|Other|Treatment difference|Least Squares Mean Difference|-2.1|Standard Error of the Mean|4.8|||2-Sided|95.0|-11.6|7.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4|
1616510|NCT02434328|2967489|Other|Treatment difference|Least Squares Mean Difference|0.3|Standard Error of the Mean|0.16|||2-Sided|95.0|0.0|0.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96|
1616511|NCT02434328|2967489|Other|Treatment difference|Least Squares Mean Difference|0.3|Standard Error of the Mean|0.17|||2-Sided|95.0|-0.1|0.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48|
1616512|NCT02434328|2967489|Other|Treatment difference|Least Squares Mean Difference|0.3|Standard Error of the Mean|0.18|||2-Sided|95.0|0.0|0.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12|
1616513|NCT02434328|2967490|Other|Treatment difference|Least Squares Mean Difference|-33.5|Standard Error of the Mean|8.84|||2-Sided|95.0|-50.8|-16.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96|
1616514|NCT02434328|2967490|Other|Treatment difference|Least Squares Mean Difference|-30.8|Standard Error of the Mean|8.53|||2-Sided|95.0|-47.6|-14.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48|
1616515|NCT02434328|2967491|Other|Treatment difference|Least Squares Mean Difference|-36.3|Standard Error of the Mean|9.56|||2-Sided|95.0|-55.1|-17.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)||
1616516|NCT02434328|2967492|Other|Treatment difference|Least Squares Mean Difference|-36.1|Standard Error of the Mean|9.13|||2-Sided|95.0|-54.0|-18.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)||
1616517|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-42.6|Standard Error of the Mean|9.87|||2-Sided|95.0|-62.0|-23.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96|
1616518|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-29.1|Standard Error of the Mean|9.56|||2-Sided|95.0|-47.9|-10.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92|
1616519|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-42.6|Standard Error of the Mean|9.84|||2-Sided|95.0|-61.9|-23.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88|
1616520|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-31.0|Standard Error of the Mean|9.48|||2-Sided|95.0|-49.6|-12.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84|
1616521|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-40.9|Standard Error of the Mean|9.94|||2-Sided|95.0|-60.4|-21.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80|
1616522|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-28.0|Standard Error of the Mean|9.43|||2-Sided|95.0|-46.5|-9.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76|
1616523|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-47.3|Standard Error of the Mean|9.69|||2-Sided|95.0|-66.4|-28.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72|
1616524|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-23.7|Standard Error of the Mean|9.31|||2-Sided|95.0|-42.0|-5.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68|
1616525|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-45.8|Standard Error of the Mean|9.7|||2-Sided|95.0|-64.9|-26.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64|
1616526|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-31.1|Standard Error of the Mean|9.34|||2-Sided|95.0|-49.5|-12.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60|
1616527|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-43.1|Standard Error of the Mean|9.86|||2-Sided|95.0|-62.4|-23.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56|
1616528|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-28.1|Standard Error of the Mean|9.01|||2-Sided|95.0|-45.8|-10.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52|
1616529|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-49.9|Standard Error of the Mean|9.68|||2-Sided|95.0|-68.9|-30.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48|
1616530|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-19.2|Standard Error of the Mean|9.24|||2-Sided|95.0|-37.3|-1.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44|
1616531|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-44.7|Standard Error of the Mean|9.57|||2-Sided|95.0|-63.5|-25.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40|
1616532|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-30.4|Standard Error of the Mean|8.94|||2-Sided|95.0|-48.0|-12.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36|
1616533|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-33.7|Standard Error of the Mean|9.54|||2-Sided|95.0|-52.4|-15.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32|
1616534|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-23.7|Standard Error of the Mean|9.34|||2-Sided|95.0|-42.0|-5.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28|
1616535|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-47.8|Standard Error of the Mean|9.42|||2-Sided|95.0|-66.3|-29.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24|
1616536|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-2.9|Standard Error of the Mean|9.12|||2-Sided|95.0|-20.9|15.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20|
1616537|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-40.2|Standard Error of the Mean|9.51|||2-Sided|95.0|-58.9|-21.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16|
1616538|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-30.3|Standard Error of the Mean|8.45|||2-Sided|95.0|-46.9|-13.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12|
1616539|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-29.5|Standard Error of the Mean|8.18|||2-Sided|95.0|-45.6|-13.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8|
1616540|NCT02434328|2967493|Other|Treatment difference|Least Squares Mean Difference|-17.7|Standard Error of the Mean|7.57|||2-Sided|95.0|-32.6|-2.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4|
1616541|NCT02434328|2967494|Other||Difference in proportions|-2.0|||||2-Sided|95.0|-8.1|4.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1616542|NCT02434328|2967494|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-6.5|5.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1616543|NCT02434328|2967494|Other||Difference in proportions|-1.3|||||2-Sided|95.0|-7.4|4.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1616544|NCT02434328|2967494|Other||Difference in proportions|-2.4|||||2-Sided|95.0|-8.3|3.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1616545|NCT02434328|2967494|Other||Difference in proportions|0.5|||||2-Sided|95.0|-5.6|6.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1616546|NCT02434328|2967494|Other||Difference in proportions|-2.0|||||2-Sided|95.0|-8.1|4.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1616547|NCT02434328|2967494|Other||Difference in proportions|-1.6|||||2-Sided|95.0|-7.9|4.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1616548|NCT02434328|2967494|Other||Difference in proportions|-3.1|||||2-Sided|95.0|-9.5|2.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1616549|NCT02434328|2967494|Other||Difference in proportions|-2.8|||||2-Sided|95.0|-8.9|3.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1616550|NCT02434328|2967494|Other||Difference in proportions|-4.7|||||2-Sided|95.0|-10.8|1.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1616551|NCT02434328|2967494|Other||Difference in proportions|-1.9|||||2-Sided|95.0|-7.7|4.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1616552|NCT02434328|2967494|Other||Difference in proportions|-1.8|||||2-Sided|95.0|-7.7|4.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1616553|NCT02434328|2967494|Other||Difference in proportions|0.4|||||2-Sided|95.0|-5.4|6.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1616554|NCT02434328|2967494|Other||Difference in proportions|-1.4|||||2-Sided|95.0|-7.5|5.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1616555|NCT02434328|2967494|Other||Difference in proportions|-1.7|||||2-Sided|95.0|-7.6|4.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1616556|NCT02434328|2967494|Other||Difference in proportions|-3.7|||||2-Sided|95.0|-9.6|2.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1616557|NCT02434328|2967494|Other||Difference in proportions|-3.1|||||2-Sided|95.0|-9.6|2.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1616558|NCT02434328|2967494|Other||Difference in proportions|-3.2|||||2-Sided|95.0|-9.3|2.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1616559|NCT02434328|2967494|Other||Difference in proportions|-3.1|||||2-Sided|95.0|-9.0|3.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1616560|NCT02434328|2967494|Other||Difference in proportions|-2.2|||||2-Sided|95.0|-8.2|4.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1616561|NCT02434328|2967494|Other||Difference in proportions|0.3|||||2-Sided|95.0|-5.4|6.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1616562|NCT02434328|2967494|Other||Difference in proportions|-2.5|||||2-Sided|95.0|-8.4|3.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1616563|NCT02434328|2967494|Other||Difference in proportions|-2.1|||||2-Sided|95.0|-8.1|3.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1616564|NCT02434328|2967494|Other||Difference in proportions|-4.0|||||2-Sided|95.0|-9.2|1.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1616565|NCT02434328|2967495|Other||Difference in proportions|-0.1|||||2-Sided|95.0|-5.1|4.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1616566|NCT02434328|2967495|Other||Difference in proportions|-1.5|||||2-Sided|95.0|-6.5|3.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1616567|NCT02434328|2967495|Other||Difference in proportions|-1.2|||||2-Sided|95.0|-5.7|3.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1616568|NCT02434328|2967495|Other||Difference in proportions|-0.4|||||2-Sided|95.0|-5.2|4.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1616569|NCT02434328|2967495|Other||Difference in proportions|-1.2|||||2-Sided|95.0|-6.0|3.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1616570|NCT02434328|2967495|Other||Difference in proportions|0.7|||||2-Sided|95.0|-4.4|5.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1616571|NCT02434328|2967495|Other||Difference in proportions|0.7|||||2-Sided|95.0|-4.3|5.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1616572|NCT02434328|2967495|Other||Difference in proportions|1.8|||||2-Sided|95.0|-2.8|6.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1616573|NCT02434328|2967495|Other||Difference in proportions|0.5|||||2-Sided|95.0|-4.0|5.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1616574|NCT02434328|2967495|Other||Difference in proportions|1.2|||||2-Sided|95.0|-3.6|5.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1616575|NCT02434328|2967495|Other||Difference in proportions|1.8|||||2-Sided|95.0|-2.8|6.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1616576|NCT02434328|2967495|Other||Difference in proportions|2.1|||||2-Sided|95.0|-2.5|6.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1616577|NCT02434328|2967495|Other||Difference in proportions|-0.7|||||2-Sided|95.0|-5.1|3.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1616578|NCT02434328|2967495|Other||Difference in proportions|2.9|||||2-Sided|95.0|-1.4|7.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1616579|NCT02434328|2967495|Other||Difference in proportions|1.0|||||2-Sided|95.0|-3.8|5.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1616580|NCT02434328|2967495|Other||Difference in proportions|3.4|||||2-Sided|95.0|-0.7|8.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1616581|NCT02434328|2967495|Other||Difference in proportions|1.2|||||2-Sided|95.0|-3.2|5.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1616582|NCT02434328|2967495|Other||Difference in proportions|2.6|||||2-Sided|95.0|-1.7|7.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1616583|NCT02434328|2967495|Other||Difference in proportions|3.1|||||2-Sided|95.0|-1.3|7.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Number of subjects with >=5 letter loss from baseline in BCVA (letters read) at each post-baseline visit - Week 24|
1616584|NCT02434328|2967495|Other||Difference in proportions|3.7|||||2-Sided|95.0|-0.4|7.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1616585|NCT02434328|2967495|Other||Difference in proportions|1.9|||||2-Sided|95.0|-1.9|6.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1616586|NCT02434328|2967495|Other||Difference in proportions|-1.0|||||2-Sided|95.0|-5.0|3.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1616587|NCT02434328|2967495|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-4.4|3.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1616588|NCT02434328|2967495|Other||Difference in proportions|-0.2|||||2-Sided|95.0|-3.5|3.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1616589|NCT02434328|2967496|Other||Difference in proportions|-1.0|||||2-Sided|95.0|-4.9|3.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1616590|NCT02434328|2967496|Other||Difference in proportions|-1.8|||||2-Sided|95.0|-5.7|2.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1616591|NCT02434328|2967496|Other||Difference in proportions|-0.7|||||2-Sided|95.0|-4.5|3.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1616720|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.9|Standard Error of the Mean|0.98|||2-Sided|95.0|-2.8|1.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72|
1616592|NCT02434328|2967496|Other||Difference in proportions|0.2|||||2-Sided|95.0|-3.6|4.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1616593|NCT02434328|2967496|Other||Difference in proportions|-0.7|||||2-Sided|95.0|-4.5|3.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1616594|NCT02434328|2967496|Other||Difference in proportions|0.4|||||2-Sided|95.0|-3.5|4.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1616595|NCT02434328|2967496|Other||Difference in proportions|-0.1|||||2-Sided|95.0|-4.0|3.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1616596|NCT02434328|2967496|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-4.2|3.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1616597|NCT02434328|2967496|Other||Difference in proportions|-0.1|||||2-Sided|95.0|-4.0|4.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1616598|NCT02434328|2967496|Other||Difference of proportions|1.0|||||2-Sided|95.0|-2.6|4.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1616599|NCT02434328|2967496|Other||Difference in proportions|1.2|||||2-Sided|95.0|-2.8|5.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1616600|NCT02434328|2967496|Other||Difference in proportions|0.9|||||2-Sided|95.0|-2.8|4.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1616601|NCT02434328|2967496|Other||Difference in proportions|-0.4|||||2-Sided|95.0|-4.0|3.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1616602|NCT02434328|2967496|Other||Difference in proportions|2.5|||||2-Sided|95.0|-1.1|6.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1616603|NCT02434328|2967496|Other||Difference in proportions|1.2|||||2-Sided|95.0|-2.4|5.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1616604|NCT02434328|2967496|Other||Difference in proportions|0.3|||||2-Sided|95.0|-3.0|4.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1616605|NCT02434328|2967496|Other||Difference in proportions|-0.1|||||2-Sided|95.0|-3.8|3.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1616606|NCT02434328|2967496|Other||Difference in proportions|0.3|||||2-Sided|95.0|-3.2|3.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1616607|NCT02434328|2967496|Other||Difference in proportions|-0.7|||||2-Sided|95.0|-3.9|2.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1616608|NCT02434328|2967496|Other||Difference in proportions|1.4|||||2-Sided|95.0|-1.7|4.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1616609|NCT02434328|2967496|Other||Difference in proportions|-1.4|||||2-Sided|95.0|-4.4|1.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1616610|NCT02434328|2967496|Other||Difference in proportions|-0.3|||||2-Sided|95.0|-2.8|2.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1616611|NCT02434328|2967496|Other||Difference in proportions|0.0|||||2-Sided|95.0|-2.2|2.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1616612|NCT02434328|2967496|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-2.6|1.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1616613|NCT02434328|2967497|Other||Difference in proportions|-0.4|||||2-Sided|95.0|-3.8|3.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1616614|NCT02434328|2967497|Other||Difference in proportions|-0.4|||||2-Sided|95.0|-3.8|3.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1616615|NCT02434328|2967497|Other||Difference in proportions|-0.2|||||2-Sided|95.0|-3.5|3.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1616616|NCT02434328|2967497|Other||Difference in proportions|0.2|||||2-Sided|95.0|-3.1|4.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1616617|NCT02434328|2967497|Other||Difference in proportions|0.9|||||2-Sided|95.0|-2.4|4.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1616618|NCT02434328|2967497|Other||Difference in proportions|0.7|||||2-Sided|95.0|-2.5|4.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1616619|NCT02434328|2967497|Other||Difference in proportions|0.9|||||2-Sided|95.0|-2.5|4.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1616620|NCT02434328|2967497|Other||Difference in proportions|-0.9|||||2-Sided|95.0|-4.2|2.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1616621|NCT02434328|2967497|Other||Difference in proportions|0.7|||||2-Sided|95.0|-2.7|4.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1616622|NCT02434328|2967497|Other||Difference in proportions|0.6|||||2-Sided|95.0|-2.5|4.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1616623|NCT02434328|2967497|Other||Difference in proportions|0.6|||||2-Sided|95.0|-2.8|3.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1616624|NCT02434328|2967497|Other||Difference in proportions|-1.0|||||2-Sided|95.0|-4.3|2.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1616625|NCT02434328|2967497|Other||Difference in proportions|-1.0|||||2-Sided|95.0|-3.9|2.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1616626|NCT02434328|2967497|Other||Difference in proportions|0.1|||||2-Sided|95.0|-2.7|3.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1616627|NCT02434328|2967497|Other||Difference in proportions|1.2|||||2-Sided|95.0|-1.7|4.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1616628|NCT02434328|2967497|Other||Difference in proportions|0.4|||||2-Sided|95.0|-2.3|3.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1616629|NCT02434328|2967497|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-3.2|2.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1616630|NCT02434328|2967497|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-3.0|2.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1616631|NCT02434328|2967497|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-3.0|2.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1616632|NCT02434328|2967497|Other||Difference in proportions|0.6|||||2-Sided|95.0|-2.0|3.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1616633|NCT02434328|2967497|Other||Difference in proportions|0.0|||||2-Sided|95.0|-2.1|2.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1616634|NCT02434328|2967497|Other||Difference in proportions|0.0|||||2-Sided|95.0|-1.9|2.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2 mg) was estimated using a bootstrap method.|Week 12|
1616635|NCT02434328|2967497|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-2.3|1.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1616636|NCT02434328|2967497|Other||Difference in proportions|0.0|||||2-Sided|95.0|-1.6|1.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1616637|NCT02434328|2967498|Other||Difference in proportions|3.1|||||2-Sided|95.0|-3.9|10.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1616638|NCT02434328|2967498|Other||Difference in proportions|3.7|||||2-Sided|95.0|-3.0|10.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1616639|NCT02434328|2967498|Other||Difference in proportions|0.9|||||2-Sided|95.0|-6.1|7.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1616640|NCT02434328|2967498|Other||Difference in proportions|-2.7|||||2-Sided|95.0|-9.3|4.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1616641|NCT02434328|2967498|Other||Difference in proportions|4.2|||||2-Sided|95.0|-2.8|10.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1616642|NCT02434328|2967498|Other||Difference in proportions|2.0|||||2-Sided|95.0|-5.1|8.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1616643|NCT02434328|2967498|Other||Difference in proportions|1.1|||||2-Sided|95.0|-5.8|7.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1616644|NCT02434328|2967498|Other||Difference in proportions|-1.5|||||2-Sided|95.0|-8.6|4.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1616645|NCT02434328|2967498|Other||Difference in proportions|2.3|||||2-Sided|95.0|-4.5|9.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1616646|NCT02434328|2967498|Other||Difference in proportions|-0.7|||||2-Sided|95.0|-7.8|6.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1616647|NCT02434328|2967498|Other||Difference in proportions|-1.7|||||2-Sided|95.0|-8.6|4.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1616648|NCT02434328|2967498|Other||Difference in proportions|-2.7|||||2-Sided|95.0|-9.8|4.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1616649|NCT02434328|2967498|Other||Difference in proportions|-0.2|||||2-Sided|95.0|-7.4|6.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1616650|NCT02434328|2967498|Other||Difference in proportions|-1.5|||||2-Sided|95.0|-8.5|5.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1616651|NCT02434328|2967498|Other||Difference in proportions|-1.3|||||2-Sided|95.0|-8.2|5.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1616652|NCT02434328|2967498|Other||Difference in proportions|-2.3|||||2-Sided|95.0|-9.2|4.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1616653|NCT02434328|2967498|Other||Difference in proportions|-1.9|||||2-Sided|95.0|-8.2|4.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1616654|NCT02434328|2967498|Other||Difference in proportions|-5.9|||||2-Sided|95.0|-12.8|0.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1616655|NCT02434328|2967498|Other||Difference in proportions|-3.2|||||2-Sided|95.0|-9.9|3.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1616656|NCT02434328|2967498|Other||Difference in proportions|-5.3|||||2-Sided|95.0|-12.3|1.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1616657|NCT02434328|2967498|Other||Difference in proportions|-1.4|||||2-Sided|95.0|-8.4|5.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1616658|NCT02434328|2967498|Other||Difference in proportions|-3.7|||||2-Sided|95.0|-10.7|3.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1616659|NCT02434328|2967498|Other||Difference in proportions|-3.2|||||2-Sided|95.0|-10.2|3.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1616660|NCT02434328|2967498|Other||Difference in proportions|-3.5|||||2-Sided|95.0|-10.4|3.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1616661|NCT02434328|2967499|Other||Difference in proportions|0.1|||||2-Sided|95.0|-7.0|6.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1616662|NCT02434328|2967499|Other||Difference in proportions|1.9|||||2-Sided|95.0|-5.0|8.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1616663|NCT02434328|2967499|Other||Difference in proportions|-2.5|||||2-Sided|95.0|-9.6|3.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1616664|NCT02434328|2967499|Other||Difference in proportions|-3.5|||||2-Sided|95.0|-10.4|3.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1616665|NCT02434328|2967499|Other||Difference in proportions|-0.7|||||2-Sided|95.0|-7.5|6.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1616666|NCT02434328|2967499|Other||Difference in proportions|0.5|||||2-Sided|95.0|-6.5|7.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1616667|NCT02434328|2967499|Other||Difference in proportions|-3.6|||||2-Sided|95.0|-10.4|2.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1616668|NCT02434328|2967499|Other||Difference in proportions|-1.7|||||2-Sided|95.0|-8.4|5.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1616669|NCT02434328|2967499|Other||Difference in proportions|-1.7|||||2-Sided|95.0|-8.8|5.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1616670|NCT02434328|2967499|Other|Hypothesis testing not pre-specified.|Difference in proportions|-2.8|||||2-Sided|95.0|-9.6|4.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1616671|NCT02434328|2967499|Other||Difference in proportions|-2.8|||||2-Sided|95.0|-9.8|4.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1616672|NCT02434328|2967499|Other||Difference in proportions|-1.3|||||2-Sided|95.0|-8.0|5.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1616673|NCT02434328|2967499|Other||Difference in proportions|-1.9|||||2-Sided|95.0|-8.7|4.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1616674|NCT02434328|2967499|Other||Difference in proportions|-3.0|||||2-Sided|95.0|-10.3|4.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1616721|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.7|Standard Error of the Mean|0.96|||2-Sided|95.0|-2.5|1.2|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68|
1616675|NCT02434328|2967499|Other||Difference in proportions|-3.1|||||2-Sided|95.0|-9.9|3.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1616676|NCT02434328|2967499|Other||Difference in proportions|-5.4|||||2-Sided|95.0|-12.1|1.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1616677|NCT02434328|2967499|Other||Difference in proportions|-2.6|||||2-Sided|95.0|-9.4|4.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1616678|NCT02434328|2967499|Other||Difference in proportions|-2.4|||||2-Sided|95.0|-9.6|4.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1616679|NCT02434328|2967499|Other||Difference in proportions|-3.7|||||2-Sided|95.0|-10.7|3.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1616680|NCT02434328|2967499|Other||Difference in proportions|-4.6|||||2-Sided|95.0|-11.2|2.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1616681|NCT02434328|2967499|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-7.3|6.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1616682|NCT02434328|2967499|Other||Difference in proportions|-3.8|||||2-Sided|95.0|-10.1|2.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1616683|NCT02434328|2967499|Other||Difference in proportions|-6.0|||||2-Sided|95.0|-13.0|0.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1616684|NCT02434328|2967499|Other||Difference in proportions|-2.1|||||2-Sided|95.0|-7.6|3.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1616685|NCT02434328|2967500|Other||Difference in proportions|-2.4|||||2-Sided|95.0|-8.8|4.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1616686|NCT02434328|2967500|Other||Difference in proportions|-1.7|||||2-Sided|95.0|-7.9|4.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1616687|NCT02434328|2967500|Other||Difference in proportions|-5.8|||||2-Sided|95.0|-11.8|0.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1616688|NCT02434328|2967500|Other||Difference in proportions|-3.8|||||2-Sided|95.0|-9.9|2.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1616689|NCT02434328|2967500|Other||Difference in proportions|-2.6|||||2-Sided|95.0|-9.0|3.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1616690|NCT02434328|2967500|Other||Difference in proportions|-2.4|||||2-Sided|95.0|-8.8|4.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1616691|NCT02434328|2967500|Other||Difference in proportions|-4.1|||||2-Sided|95.0|-10.2|2.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1616692|NCT02434328|2967500|Other||Difference in proportions|-3.5|||||2-Sided|95.0|-9.9|3.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1616693|NCT02434328|2967500|Other||Difference in proportions|-1.4|||||2-Sided|95.0|-7.9|5.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1616694|NCT02434328|2967500|Other||Difference in proportions|-2.2|||||2-Sided|95.0|-8.3|4.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1616695|NCT02434328|2967500|Other||Difference in proportions|-1.1|||||2-Sided|95.0|-7.7|5.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1616696|NCT02434328|2967500|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-7.0|5.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1616697|NCT02434328|2967500|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-7.1|5.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1616698|NCT02434328|2967500|Other||Difference in proportions|-4.6|||||2-Sided|95.0|-11.3|1.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1616699|NCT02434328|2967500|Other||Difference in proportions|-4.7|||||2-Sided|95.0|-11.5|1.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1616700|NCT02434328|2967500|Other||Difference in proportions|-4.9|||||2-Sided|95.0|-11.6|1.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1616701|NCT02434328|2967500|Other||Difference in proportions|-3.6|||||2-Sided|95.0|-10.5|2.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1616702|NCT02434328|2967500|Other||Difference in proportions|-3.7|||||2-Sided|95.0|-9.9|2.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1616703|NCT02434328|2967500|Other||Difference in proportions|0.9|||||2-Sided|95.0|-5.2|6.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1616704|NCT02434328|2967500|Other||Difference in proportions|-3.1|||||2-Sided|95.0|-8.8|2.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1616705|NCT02434328|2967500|Other||Difference in proportions|-2.3|||||2-Sided|95.0|-8.4|3.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1616706|NCT02434328|2967500|Other||Difference in proportions|-5.0|||||2-Sided|95.0|-10.5|0.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1616707|NCT02434328|2967500|Other||Difference in proportions|-4.3|||||2-Sided|95.0|-9.5|1.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1616708|NCT02434328|2967500|Other||Difference in proportions|-1.3|||||2-Sided|95.0|-5.1|2.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1616709|NCT02434328|2967501|Other|Treatment difference|Least Squares Mean Difference|-0.6|Standard Error of the Mean|0.99|||2-Sided|95.0|-2.5|1.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)||
1616710|NCT02434328|2967502|Other|Treatment difference|Least Squares Mean Difference|-0.8|Standard Error of the Mean|0.82|||2-Sided|95.0|-2.4|0.8||||||Week 12 to Week 96|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)
1616711|NCT02434328|2967502|Other|Treatment difference|Least Squares Mean Difference|-1.1|Standard Error of the Mean|0.74|||2-Sided|95.0|-2.5|0.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 48|
1616712|NCT02434328|2967503|Other|Treatment difference|Least Squares Mean Difference|-0.8|Standard Error of the Mean|0.78|||2-Sided|95.0|-2.4|0.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96|
1616713|NCT02434328|2967503|Other|Treatment difference|Least Squares Mean Difference|-1.1|Standard Error of the Mean|0.69|||2-Sided|95.0|-2.4|0.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48|
1616714|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.4|Standard Error of the Mean|1.04|||2-Sided|95.0|-2.5|1.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96|
1616715|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.4|Standard Error of the Mean|1.02|||2-Sided|95.0|-2.4|1.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92|
1616716|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.6|Standard Error of the Mean|0.99|||2-Sided|95.0|-2.6|1.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88|
1616717|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.9|Standard Error of the Mean|1.0|||2-Sided|95.0|-2.9|1.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84|
1616718|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.2|Standard Error of the Mean|0.99|||2-Sided|95.0|-2.1|1.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80|
1616719|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.5|Standard Error of the Mean|0.98|||2-Sided|95.0|-2.5|1.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76|
1616753|NCT02431468|2967896|Superiority||Mean Difference (Net)|6.5|||<|0.1|2-Sided|80.0|||||t-test, 1 sided|||Change from baseline in SIB in the Completer Analysis Set (CAS)|
1616724|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.7|Standard Error of the Mean|0.92|||2-Sided|95.0|-2.5|1.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56|
1616725|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.7|Standard Error of the Mean|0.9|||2-Sided|95.0|-2.5|1.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52|
1616726|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.7|Standard Error of the Mean|0.86|||2-Sided|95.0|-2.4|1.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48|
1616727|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-1.6|Standard Error of the Mean|0.86|||2-Sided|95.0|-3.2|0.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44|
1616728|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-1.2|Standard Error of the Mean|0.85|||2-Sided|95.0|-2.9|0.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40|
1616729|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-1.2|Standard Error of the Mean|0.84|||2-Sided|95.0|-2.9|0.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36|
1616730|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.9|Standard Error of the Mean|0.81|||2-Sided|95.0|-2.5|0.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32|
1616731|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-1.1|Standard Error of the Mean|0.82|||2-Sided|95.0|-2.7|0.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28|
1616732|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.9|Standard Error of the Mean|0.79|||2-Sided|95.0|-2.5|0.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24|
1616733|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-1.5|Standard Error of the Mean|0.76|||2-Sided|95.0|-3.0|0.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20|
1616734|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-0.9|Standard Error of the Mean|0.73|||2-Sided|95.0|-2.3|0.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16|
1616735|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-1.0|Standard Error of the Mean|0.71|||2-Sided|95.0|-2.4|0.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12|
1616736|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-1.0|Standard Error of the Mean|0.63|||2-Sided|95.0|-2.2|0.2|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8|
1616737|NCT02434328|2967504|Other|Treatment difference|Least Squares Mean Difference|-1.0|Standard Error of the Mean|0.52|||2-Sided|95.0|-2.0|0.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4|
1616738|NCT02434328|2967509|Non-Inferiority|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-1.2|Standard Error of the Mean|0.82||0.0003|2-Sided|95.0|-2.8|0.5||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)||
1616739|NCT02434328|2967510|Non-Inferiority|The noninferiority margin was 4 letters.|Least Squares Mean Difference|-0.7|Standard Error of the Mean|0.86|<|0.0001|2-Sided|95.0|-2.4|1.0||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)||
1616740|NCT02433288|2967758|Superiority or Other||Mean Difference (Final Values)|0.63|Standard Error of the Mean|1.99||0.7514|2-Sided|95.0|-3.27|4.53|||ANCOVA|linear model including terms for randomized group and baseline LDL-C|||
1616741|NCT02433288|2967759|Superiority or Other||Mean Difference (Final Values)|-1.38|Standard Error of the Mean|1.6||0.3939|2-Sided|95.0|-4.56|1.8|||t-test, 2 sided||||
1616742|NCT02433288|2967760|Superiority or Other||Mean Difference (Final Values)|-20.24|Standard Error of the Mean|3.39|<|0.0001|2-Sided|95.0|-26.91|-13.57|||t-test, 2 sided||||
1616743|NCT02433288|2967761|Superiority or Other|||||||0.0017|||||||Chi-squared||||
1616744|NCT02433288|2967762|Superiority or Other|||||||0.0019|||||||Log Rank||||
1616745|NCT02433080|2967773|Other||Mean Difference (Net)|6.4||||0.05|2-Sided|95.0|-3.6|16.5|||ANCOVA|||This statistical analysis applies for the outcomes 2-8.|
1616746|NCT02432144|2967825|Superiority||LS Mean|-57.85|||<|0.0001|2-Sided|95.0|-71.87|-43.82||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 48|
1616747|NCT02432144|2967825|Superiority||LS Mean|-60.8|Standard Error of the Mean|5.992|<|0.0001|2-Sided|95.0|-72.54|-49.06||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 36|
1616748|NCT02432144|2967825|Superiority||LS Mean|-64.12|Standard Error of the Mean|4.016|<|0.0001|2-Sided|95.0|-71.99|-56.24||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 24|
1616749|NCT02432144|2967825|Superiority||LS Mean|-67.18|Standard Error of the Mean|3.224|<|0.0001|2-Sided|95.0|-73.49|-60.86||P-values are from a GEE model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 12|
1616750|NCT02432144|2967825|Superiority||LS Mean|-62.28|Standard Error of the Mean|4.946|<|0.0001|2-Sided|95.0|-71.98|-52.59||P-values are from generalized estimating equation (GEE) model including baseline value and visit (in this study) as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model|||Week 0|
1616751|NCT02431754|2967848|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.1485|2-Sided|95.0|-1.69|0.26|||Mixed Models Analysis||||
1616752|NCT02431754|2967849|Superiority or Other|||||||0.0937|||||||Normal approximation (Z-test)||||
1617134|NCT02420353|2968684|Other|mixed effects model||||||0.0122|||||||Mixed Models Analysis||||
1616754|NCT02431468|2967896|Superiority||Mean Difference (Net)|6.5|||<|0.1|2-Sided|80.0||||LSM and two-sided 80% CI were provided for treatment group differences and estimated endpoint values. A true mean difference in change from baseline in the SIB (one-sided at α=0.10) of at least 6.5 points in favor of bryostatin groups was assumed.|t-test, 1 sided|||The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the Severe Impairment Battery (SIB) after 12 weeks of treatment. A linear model was used for both estimation and significance testing. Primary analysis populations were defined as the Full Analysis Set (FAS) and the Completer Analysis Set (CAS)|
1616755|NCT02431299|2967909|Superiority or Other||||||<|0.05|||||||Regression, Linear|||Hypothesized that higher levels of IMR competence would predict higher IMRS outcomes.|
1616756|NCT02431299|2967910|Superiority or Other||||||<|0.01||||||Whether there were significant changes in the IMRS baseline scores to IMRS follow up scores.|t-test, 2 sided|t = 2.78, df = 182|||
1616757|NCT02431247|2967935|Other||LS mean difference|1.7|Standard Error of the Mean|0.588|=|0|2-Sided|95.0|0.539|2.858|||ANCOVA|||Spine region BMD (Week 48)|
1616758|NCT02431247|2967935|Other||LS mean difference|2.09|Standard Error of the Mean|0.421|<|0.001|2-Sided|95.0|1.259|2.919|||ANCOVA|||Spine region BMD (Week 24)|
1616759|NCT02431247|2967935|Other||LS mean difference|2.86|Standard Error of the Mean|0.47|<|0.001|2-Sided|95.0|1.934|3.791|||ANCOVA|||Hip region BMD (Week 48)|
1616760|NCT02431247|2967935|Other||LS mean difference|1.95|Standard Error of the Mean|0.368|<|0.001|2-Sided|95.0|1.227|2.678|||ANCOVA|||Hip region BMD (Week 24)|
1616761|NCT02431247|2967940|Other||||||=|0|||||||Wilcoxon rank sum test||||
1616762|NCT02431247|2967941|Other||||||<|0.001|||||||Wilcoxon rank sum test||||
1616763|NCT02431247|2967942|Other||||||<|0.001|||||||Wilcoxon rank sum test||||
1616764|NCT02431247|2967943|Other||||||=|0|||||||Wilcoxon rank sum test||||
1616765|NCT02431247|2967944|Other||||||=|0|||||||Wilcoxon rank sum test||||
1616766|NCT02431247|2967946|Other||LS mean difference|2.4|Standard Error of the Mean|0.747|=|0|2-Sided|95.0|0.93|3.87|||ANCOVA||||
1616767|NCT02431247|2967947|Other||LS mean difference|6.04|Standard Error of the Mean|1.126|<|0.001|2-Sided|95.0|3.83|8.25|||ANCOVA||||
1616768|NCT02431247|2967948|Other||LS mean difference|3.12|Standard Error of the Mean|0.786|<|0.001|2-Sided|95.0|1.57|4.66|||ANCOVA||||
1616769|NCT02431247|2967949|Other||LS mean difference|-0.04|Standard Error of the Mean|0.008|<|0.001|2-Sided|95.0|-0.05|-0.02|||ANCOVA||||
1616770|NCT02431247|2967951|Other||LS mean difference|18.48|Standard Error of the Mean|14.808|=|0|2-Sided|95.0|-10.595|47.55|||ANCOVA||||
1616771|NCT02431247|2967952|Other||Least square mean difference|-0.05|Standard Error of the Mean|0.063|=|0|2-Sided|95.0|-0.171|0.074|||ANCOVA||||
1616772|NCT02431247|2967955|Non-Inferiority|One-sided p-value for non-inferiority of Test versus Control arm. The non-inferiority margin is 10%.|Difference in percentage|2.7|||<|0.001|2-Sided|95.0|-1.6|7.1|||Mantel Haenszel||||
1616773|NCT02431052|2967956|Other|||||||0.0055|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (vehicle treatment groups included as single combined treatment group).|||
1616774|NCT02431052|2967957|Other|||||||0.0002|||||||Cochran-Mantel-Haenszel|ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.|||
1616775|NCT02431052|2967958|Other|||||||0.0006|||||||Cochran-Mantel-Haenszel|ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.|||
1616776|NCT02430389|2967985|Superiority or Other|||||||0.348|||||||t-test, 2 sided||||
1616777|NCT02430389|2967986|Superiority or Other|||||||0.0575|||||||t-test, 2 sided||||
1616778|NCT02429791|2968022|Superiority|||||||0.099||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test||||
1616779|NCT02429791|2968022|Superiority|||||||0.002||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test||||
1616780|NCT02429791|2968022|Superiority|||||||0.063||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test||||
1616781|NCT02429791|2968022|Superiority|||||||0.005||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test||||
1616782|NCT02429791|2968022|Superiority||||||<|0.001||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test||||
1616783|NCT02429791|2968022|Superiority||||||<|0.001||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test||||
1616784|NCT02429791|2968022|Superiority||||||<|0.024||||||P-value to assess HIVTSQs Total score difference between treatment groups (Week 48)|Wilcoxon rank sum test||||
1616785|NCT02429791|2968022|Superiority||||||<|0.001||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 24)|Wilcoxon rank sum test||||
1616786|NCT02429791|2968022|Superiority||||||<|0.002||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 4)|Wilcoxon rank sum test||||
1616787|NCT02429791|2968025|Superiority||Mean Difference (Final Values)|-1.569||||0.038|2-Sided|95.0|-3.048|-0.09||P value to assess difference between treatment groups (Week 48)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.||
1616788|NCT02429791|2968025|Other|||||||0.048||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 48)|ANCOVA||||
1616789|NCT02429791|2968025|Superiority||Mean Difference (Final Values)|-1.192||||0.11|2-Sided|95.0|-2.656|0.271||P value to assess difference between treatment groups (Week 24)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.||
1616790|NCT02429791|2968025|Other|||||||0.001||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 24)|ANCOVA||||
1616791|NCT02429791|2968025|Superiority||Mean Difference (Final Values)|-2.924|||<|0.001|2-Sided|95.0|-4.26|-1.588||P value to assess difference between treatment groups (Week 4)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.||
1616792|NCT02429791|2968025|Other||||||<|0.94||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 4)|ANCOVA||||
1616794|NCT02429791|2968033|Other||Risk Difference (RD)|2.0|||||2-Sided|95.0|-5.1|9.0|||||INI: No formal non-inferiority margin has been pre-specified for secondary endpoints.||
1616795|NCT02429791|2968033|Other||Risk Difference (RD)|-3.1|||||2-Sided|95.0|-7.7|1.5|||||NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.||
1616796|NCT02429791|2968033|Other|||||||0.317||||||One-sided p-value from weighted least squares chi-squared statistic. A p-value <=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.|Chi-squared, Corrected||||
1616797|NCT02429791|2968046|Superiority||Odds Ratio (OR)|0.804|||<|0.001|2-Sided|95.0|0.742|0.872||P value to assess difference between treatment groups (type 1 collagen cross-linked C-telopeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616798|NCT02429791|2968046|Other||||||<|0.782||||||P-value for interaction between treatment group and baseline third agent (type 1 collagen cross-linked C-telopeptide)|ANCOVA||||
1616799|NCT02429791|2968046|Superiority||Odds Ratio (OR)|0.691|||<|0.001|2-Sided|95.0|0.628|0.759||P value to assess difference between treatment groups (osteocalcin - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616800|NCT02429791|2968046|Superiority||Odds Ratio (OR)|0.829|||<|0.001|2-Sided|95.0|0.74|0.93||P value to assess difference between treatment groups (osteocalcin - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616801|NCT02429791|2968046|Superiority||Odds Ratio (OR)|0.881|||<|0.001|2-Sided|95.0|0.823|0.943||P value to assess difference between treatment groups (osteocalcin - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616802|NCT02429791|2968046|Other||||||<|0.001||||||P-value for interaction between treatment group and Baseline third agent (osteocalcin)|ANCOVA||||
1616803|NCT02429791|2968046|Superiority||Odds Ratio (OR)|0.817|||<|0.001|2-Sided|95.0|0.774|0.863||P value to assess difference between treatment groups (procollagen type 1-N-propeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616804|NCT02429791|2968046|Other||||||<|0.677||||||P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)|ANCOVA||||
1616805|NCT02429791|2968046|Superiority||Odds Ratio (OR)|0.81|||<|0.001|2-Sided|95.0|0.742|0.884||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616806|NCT02429791|2968046|Superiority||Odds Ratio (OR)|0.825|||<|0.001|2-Sided|95.0|0.742|0.918||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616807|NCT02429791|2968046|Superiority||Odds Ratio (OR)|0.724|||<|0.001|2-Sided|95.0|0.679|0.772||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616808|NCT02429791|2968046|Other||||||<|0.001||||||P-value for interaction between treatment group and baseline third agent (bone-specific alkaline phosphatase)|ANCOVA||||
1616809|NCT02429791|2968048|Superiority||Odds Ratio (OR)|0.847||||0.002|2-Sided|95.0|0.763|0.942||P value to assess difference between treatment groups (25 hydroxy-vitamin D - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.||
1616810|NCT02429791|2968048|Superiority||Odds Ratio (OR)|0.902||||0.112|2-Sided|95.0|0.793|1.025||P value to assess difference between treatment groups (25 hydroxy-vitamin D - INI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.||
1616811|NCT02429791|2968048|Superiority||Odds Ratio (OR)|0.958||||0.275|2-Sided|95.0|0.888|1.034||P value to assess difference between treatment groups (25 hydroxy-vitamin D - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and baseline biomarker level.||
1616812|NCT02429791|2968048|Other|||||||0.007||||||P-value for interaction between treatment group and baseline third agent (25 hydroxy-vitamin D)|ANCOVA||||
1616813|NCT02429791|2968059|Other||Risk Difference (RD)|1.0|||||2-Sided|95.0|-1.9|4.0|||||Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (< or >=50 years old) and Baseline third agent (PI, NNRTI, INI). No formal non-inferiority margin has been pre-specified for secondary endpoints.||
1616814|NCT02429791|2968061|Non-Inferiority|Non-inferiority can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms is greater than -10%.|Risk Difference (RD)|-0.6|||||2-Sided|95.0|-4.3|3.0|||||Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (< or >=50 years old) and Baseline third agent (PI, NNRTI, INI).||
1616815|NCT02429258|2968081|Superiority or Other||Mean Difference (Final Values)|7.0|Standard Error of the Mean|2.86||0.017||95.0|1.3|12.7|||ANCOVA||||
1616816|NCT02429258|2968082|Superiority or Other||Mean Difference (Final Values)|-36.3|Standard Error of the Mean|9.25|<|0.001||95.0|-54.7|-17.9|||ANCOVA||||
1616817|NCT02429258|2968083|Superiority or Other||Mean Difference (Final Values)|-10.8|Standard Error of the Mean|4.55||0.019||95.0|-19.9|-1.8|||ANCOVA||||
1616818|NCT02429258|2968084|Superiority or Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.1||0.024||95.0|-0.43|-0.03|||ANCOVA||||
1616819|NCT02429258|2968085|Superiority or Other||Mean Difference (Final Values)|-40.8|Standard Error of the Mean|9.14|<|0.001||95.0|-59.0|-22.7|||ANCOVA||||
1616820|NCT02429258|2968086|Superiority or Other||Mean Difference (Final Values)|-29.7|Standard Error of the Mean|8.47|<|0.001||95.0|-46.6|-12.9|||ANCOVA||||
1616821|NCT02429258|2968087|Superiority or Other||Mean Difference (Final Values)|-16.1|Standard Error of the Mean|3.72|<|0.001||95.0|-23.5|-8.7|||ANCOVA||||
1616822|NCT02429258|2968088|Superiority or Other||Mean Difference (Final Values)|15.0|Standard Error of the Mean|3.65|<|0.001||95.0|7.7|22.2|||ANCOVA||||
1616823|NCT02429258|2968089|Superiority or Other||Mean Difference (Final Values)|1.0|Standard Error of the Mean|0.42||0.023||95.0|0.1|1.8|||ANCOVA||||
1616824|NCT02429258|2968090|Superiority or Other||Mean Difference (Final Values)|-15.3|Standard Error of the Mean|5.8||0.01||95.0|-26.8|-3.8|||ANCOVA||||
1616825|NCT02429258|2968091|Superiority or Other||Mean Difference (Final Values)|-24.0|Standard Error of the Mean|6.08|<|0.001||95.0|-36.1|-12.0|||Mixed Models Analysis||||
1616826|NCT02429115|2968092|Superiority||||||<|0.05|||||||ANOVA||||
1616827|NCT02429115|2968093|Superiority||||||<|0.05|||||||ANOVA||||
1616828|NCT02429115|2968094|Superiority||||||<|0.05|||||||ANOVA||||
1616829|NCT02428699|2968106|Superiority||Mean Difference (Net)|5.16|||<|0.0001|2-Sided|95.0|2.79|7.53|||ANCOVA|Subject as random effect,treatment and period as fixed effects,subject and period level baseline values for plasma total and free acids as covariates|Difference is test minus reference such that a positive difference favors the test treatment.||
1616830|NCT02428478|2968115|Other||||||>|0.5|||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Active Pcrit|
1616831|NCT02428478|2968115|Other||Median Change|-0.6|||>|0.037|2-Sided||||||Wilcoxon Matched-Pairs Signed-Rank Test|||Passive Pcrit|
1616832|NCT02428478|2968116|Other|||||||0.38||||||P<0.05 considered statistically significant|Wilcoxon Matched-Pairs Signed-Rank Test|||Phasic analysis|
1616833|NCT02428478|2968116|Other|||||||0.01||||||P<0.05 considered statistically significant|Wilcoxon Matched-Pairs Signed-Rank Test|||Tonic analysis|
1616834|NCT02428413|2968119|Superiority or Other|||||||0.26|||||||t-test, 2 sided||||
1616835|NCT02428413|2968120|Superiority or Other|||||||0.24|||||||t-test, 2 sided||||
1616836|NCT02427737|2968176|Superiority||||||<|0.0001|||||||Chi-squared||||
1616837|NCT02427737|2968177|Superiority||||||<|0.0001|||||||Chi-squared||||
1616838|NCT02427737|2968178|Superiority|||||||0.5267|||||||Chi-squared||||
1616839|NCT02427737|2968179|Superiority|||||||0.2396|||||||Chi-squared||||
1616840|NCT02427737|2968180|Superiority||||||<|0.0001|||||||Chi-squared||||
1616841|NCT02427737|2968185|Superiority||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|CMH test with time as a strata variable was 28.7; chi-square value with pooling all data together was 28.6||Comparison among trained and untrained sites over time|
1616842|NCT02427737|2968186|Superiority|||||||0.9065||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the quarterly average no-show rate as compared to the baseline quarter for untrained sites|
1616843|NCT02427737|2968186|Superiority|||||||0.9012||||||Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.|Chi-squared|||Change in the quarterly average no show rate as compared to the baseline quarter for trained sites|
1616844|NCT02427737|2968186|Superiority||||||<|0.01||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites|
1616845|NCT02427737|2968187|Superiority|||||||0.2764||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows as compared to the baseline quarter at untrained sites|
1616846|NCT02427737|2968187|Superiority|||||||0.276||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows compared to the baseline quarter|
1616847|NCT02427737|2968187|Superiority|||||||0.0195||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites|
1616848|NCT02427737|2968188|Superiority|||||||0.5883||||||Bonferroni-correction was not done for this nonsignificant result since the corrected p-value would be have been greater than 1, which is not possible.|Chi-squared|||Change in the quarterly average no-show rate as compared to the baseline quarter at untrained sites|
1616849|NCT02427737|2968188|Superiority|||||||0.8523||||||No Bonferroni-correction|Chi-squared|||Change in the quarterly no-shows as compared to the baseline quarter|
1616850|NCT02427737|2968188|Superiority|||||||0.2357||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites|
1616851|NCT02427737|2968190|Superiority||||||<|0.0001|||||||Chi-squared||||
1616852|NCT02427737|2968191|Superiority||||||<|0.0001||||||CMH test was used with time as a strata variable (rather than pooling all data together as in the regular chi-squared test). The CMH chi-squared value was 858.2, and the regular chi-squared value was 858.8.|Chi-squared, Corrected|Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|||
1616853|NCT02427737|2968192|Superiority||||||<|0.001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter|
1616854|NCT02427737|2968192|Superiority||||||<|0.303||||||"Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.~Chi-square analysis was used to assess equipment utilization at trained sites compared with untrained sites when stratifying by time (chi-square MH = 858.2)."|Chi-squared|||Change in the quarterly equipment utilization rate as compared to the baseline quarter Q4FY15 over time and at sites|
1616855|NCT02427737|2968192|Superiority||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared|||Comparison among trained and untrained sites|
1616856|NCT02427737|2968193|Superiority||||||<|0.001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared|||Change in the average quarterly completion rate as compared to the baseline quarter|
1616857|NCT02427737|2968193|Superiority||||||<|0.201||||||Bonferroni-correction was not done since the corrected p-value would be have been greater than 1.|Chi-squared|||Change in the average quarterly completion rate as compared to the baseline quarter|
1617135|NCT02420353|2968685|Other|mixed effects model||||||0.0357|||||||Mixed Models Analysis||||
1616858|NCT02427737|2968193|Superiority||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites|
1616859|NCT02427737|2968194|Superiority||||||<|0.01||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter|
1616860|NCT02427737|2968194|Superiority||||||<|0.3037||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Change in the average quarterly completion rate as compared to the baseline quarter|
1616861|NCT02427737|2968194|Superiority||||||<|0.0001||||||Bonferroni-corrected p-values were used after multiplying the uncorrected p-value by 10.|Chi-squared, Corrected|||Comparison among trained and untrained sites|
1616862|NCT02427646|2968198|Other|A linear mixed effects (LME) model via the maximized likelihood estimation was implemented using open-source statistical software, R (version 3.3.3). The effects of each clinical and kinematic outcome measures were examined for each participant group (ET and PD arms were separately analyzed thus no interaction effects were investigated) in separate LME models (“lme4” package using “lmer” function).|||||<|0.05|||||||Linear mixed effects model|a log-transformation ofthe RMS datasets was applied for statistical analysis|||
1616863|NCT02427646|2968199|Other|A linear mixed effects (LME) model via the maximized likelihood estimation was implemented using open-source statistical software, R (version 3.3.3). The effects of each clinical and kinematic outcome measures were examined for each participant group (ET and PD arms were separately analyzed thus no interaction effects were investigated) in separate LME models (“lme4” package using “lmer” function).|||||<|0.05|||||||Linear mixed effects model||||
1616864|NCT02427100|2968206|Superiority or Other|||||||0.00036||||||The Linear Mixed Model (LMM) regression analysis (repeated measures) was adjusted for daily minutes of accelerometer wear time, gender, age, BMI, education, and meeting physical activity guidelines at baseline.|Mixed Models Analysis|A fourth root transformation of daily accelerometer-measured minutes of MVPA was used to normalize the distribution and was included in the analyses.|||
1616865|NCT02427100|2968207|Superiority or Other|||||||0.18|||||||ANCOVA||||
1616866|NCT02426918|2968212|Non-Inferiority|Non-inferiority for the high dose was confirmed if the upper bound of the CI was < 15%.|Risk Difference (RD)|0.0|||||2-Sided|95.0|-8.32|8.38||||||Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type [cellulitis, noncellulitis] according to a Mantel-Haenszel type risk difference estimator.|
1616867|NCT02426918|2968212|Non-Inferiority|Non-inferiority for the low dose was confirmed if the upper bound of the CI was < 15% and if non-inferiority was confirmed for the high dose.|Risk Difference (RD)|-4.2|||||2-Sided|95.0|-11.42|3.0||||||Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type [cellulitis, noncellulitis] according to a Mantel-Haenszel type risk difference estimator.|
1616868|NCT02426658|2968221|Superiority|||||||0.7044|||||||Mixed Models Analysis||||
1616869|NCT02426541|2968223|Superiority or Other||Mean Difference (Final Values)|-0.003||||0.9984|2-Sided|95.0|-3.07|3.07|||ANCOVA|Adjusted for sex and baseline|||
1616870|NCT02426541|2968224|Superiority or Other||Mean Difference (Final Values)|-1.32||||0.5317|2-Sided|95.0|-5.6|2.96|||ANCOVA|Adjusted for sex and baseline|||
1616871|NCT02426541|2968225|Superiority or Other||Mean Difference (Final Values)|1.68||||0.3794|2-Sided|95.0|-2.18|5.54|||ANCOVA|Adjusted for sex and baseline|||
1616872|NCT02426125|2968248|Superiority||Hazard Ratio (HR)|0.931||||0.61|2-Sided|95.0|0.701|1.235|||Log Rank|||Global health status/QoL|
1616873|NCT02426125|2968249|Superiority||Hazard Ratio (HR)|0.652|||||2-Sided|95.0|0.376|1.131|||||||
1616874|NCT02426125|2968252|Superiority||Hazard Ratio (HR)|0.887||||0.2461|2-Sided|95.0|0.724|1.086|||Log Rank||||
1616875|NCT02426125|2968253|Superiority||Hazard Ratio (HR)|0.757||||0.0118|2-Sided|95.0|0.607|0.943|||Log Rank||||
1616876|NCT02425826|2968260|Superiority or Other (legacy)||Difference|13.5||||0.0136|2-Sided|95.0|4.4|22.7|||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test stratified by sites.|2-sided 95% CI is based on normal approximation.||
1616877|NCT02425826|2968261|Superiority or Other (legacy)||Difference|29.1|||<|0.0001|2-Sided|95.0|16.3|41.8|||Cochran-Mantel-Haenszel|2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.|Two-sided 95% CI is based on normal approximation||
1616878|NCT02425826|2968262|Superiority or Other (legacy)||LS Mean Difference|-37.0|||<|0.0001|2-Sided|95.0|-54.08|-19.91|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate|||
1616879|NCT02425826|2968264|Superiority or Other (legacy)||Mean Difference (Final Values)|14.07|||<|0.0001|2-Sided|95.0|7.16|20.97|||ANOVA|||TSQM-Global Satisfaction|
1616880|NCT02425826|2968264|Superiority or Other (legacy)||LS Mean Difference|1.4|||<|0.625|2-Sided|95.0|-4.25|7.06|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSMQ-Convenience|
1616881|NCT02425826|2968264|Superiority or Other (legacy)||LS Mean Difference|5.0|||<|0.3433|2-Sided|95.0|-5.4|15.4|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSQM - Side Effects|
1616882|NCT02425826|2968264|Superiority or Other (legacy)||LS Mean Difference|17.8|||<|0.0001|2-Sided|95.0|10.36|25.24|||ANOVA|Based on 2-way ANOVA with treatment and site as factors.||TSQM-Effectiveness|
1616883|NCT02425826|2968265|Superiority or Other (legacy)||Difference|11.8||||0.0463|2-Sided|95.0|-4.0|27.6|||Cochran-Mantel-Haenszel|p-value was based on 2-sided CMH tests stratified by sites.|Two-sided 95% CI is based on normal approximation.||
1616884|NCT02425826|2968266|Superiority or Other (legacy)||LS Mean Difference|-11.6||||0.0016|2-Sided|95.0|-18.8|-4.5|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.||The treatment comparison was only done for Week 16; End of Phase|
1616885|NCT02425826|2968267|Superiority or Other (legacy)||Difference|13.7||||0.0365|2-Sided|95.0|1.7|25.7|||Cochran-Mantel-Haenszel|2-sided p-value is calculated based on Cochran-Mantel-Haenszel test stratified by sites.|Two-sided 95% CI is based on normal approximation||
1616886|NCT02425826|2968268|Superiority or Other (legacy)||Difference|21.0|||<|0.0001|2-Sided|95.0|11.0|31.1||Two-sided p-value is based on the Cochran-Mantel-Haenszel test stratified by sites.|Cochran-Mantel-Haenszel||Two-sided 95% confidence intervals (CI) is based on normal approximation||
1616887|NCT02425826|2968269|Superiority or Other (legacy)||LS Mean Difference|-2.5||||0.0008|2-Sided|95.0|-3.9|-1.0|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.|||
1616888|NCT02425826|2968270|Superiority or Other (legacy)||LS Mean Difference|-39.84|||<|0.0001|2-Sided|95.0|-54.39|-25.3|||ANCOVA|Based on 2-way ANCOVA with treatment and site as factors and baseline value as covariate.|||
1616889|NCT02424591|2968366|Superiority or Other|||||||0.74|||||||Wilcoxon (Mann-Whitney)||||
1616890|NCT02424591|2968367|Superiority or Other|||||||0.79|||||||Wilcoxon (Mann-Whitney)||||
1616891|NCT02424591|2968368|Superiority or Other|||||||0.86|||||||Wilcoxon (Mann-Whitney)||||
1616892|NCT02424539|2968381|Other||Mean Difference (Final Values)|2.67|||<|0.001|2-Sided|95.0|1.38|3.95|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616893|NCT02424539|2968381|Other||Mean Difference (Final Values)|1.88|||<|0.004|2-Sided|95.0|0.6|3.16|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616894|NCT02424539|2968382|Other||Mean Difference (Final Values)|-0.3||||0.035|2-Sided|95.0|-0.57|-0.02|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616895|NCT02424539|2968382|Other||Mean Difference (Final Values)|-0.11||||0.442|2-Sided|95.0|-0.38|0.17|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616896|NCT02424539|2968383|Other||Mean Difference (Final Values)|-2.27|||<|0.001|2-Sided|95.0|-3.03|-1.52|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616897|NCT02424539|2968383|Other||Mean Difference (Final Values)|-2.48|||<|0.001|2-Sided|95.0|-3.23|-1.73|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616898|NCT02424539|2968384|Other||Odds Ratio (OR)|0.17|||<|0.001|2-Sided|95.0|0.1|0.29|||Regression, Logistic||Odds ratio for FF 110 µg QD versus placebo has been presented using a logistic regression model with Wald’s test with treatment, gender, age and type of Allergic Rhinitis as factors.||
1616899|NCT02424539|2968384|Other||Odds Ratio (OR)|0.2|||<|0.001|2-Sided|95.0|0.12|0.34|||Regression, Logistic||Odds ratio for FF 55 µg QD versus placebo has been presented using a logistic regression model with Wald’s test with treatment, gender, age and type of Allergic Rhinitis as factors.||
1616900|NCT02424539|2968385|Other||Mean Difference (Final Values)|-1.46|||<|0.001|2-Sided|95.0|-1.92|-0.99|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616901|NCT02424539|2968385|Other||Mean Difference (Final Values)|-1.36|||<|0.001|2-Sided|95.0|-1.83|-0.9|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616902|NCT02424539|2968386|Other||Mean Difference (Final Values)|0.66||||0.011|2-Sided|95.0|0.16|1.17|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616903|NCT02424539|2968386|Other||Mean Difference (Final Values)|0.51||||0.048|2-Sided|95.0|0.01|1.02|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616904|NCT02424539|2968387|Other||Mean Difference (Final Values)|-0.25||||0.078|2-Sided|95.0|-0.53|0.03|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616905|NCT02424539|2968387|Other||Mean Difference (Final Values)|-0.1||||0.503|2-Sided|95.0|-0.38|0.18|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616906|NCT02424539|2968388|Other||Mean Difference (Final Values)|-1.98|||<|0.001|2-Sided|95.0|-2.66|-1.29|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616907|NCT02424539|2968388|Other||Mean Difference (Final Values)|-2.15|||<|0.001|2-Sided|95.0|-2.84|-1.46|||ANCOVA||LS mean difference between placebo and FF 55 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616908|NCT02424539|2968389|Other||Odds Ratio (OR)|0.2|||<|0.001|2-Sided|95.0|0.12|0.33|||Regression, Logistic||Odds ratio for FF 110 µg QD versus placebo has been presented using a logistic regression model with Wald’s test with treatment, gender, age and type of Allergic Rhinitis as factors.||
1616909|NCT02424539|2968389|Other||Odds Ratio (OR)|0.24|||<|0.001|2-Sided|95.0|0.14|0.39|||Regression, Logistic||Odds ratio for FF 55 µg QD versus placebo has been presented using a logistic regression model with Wald’s test with treatment, gender, age and type of Allergic Rhinitis as factors.||
1616910|NCT02424539|2968390|Other||Mean Difference (Final Values)|-1.32|||<|0.001|2-Sided|95.0|-1.77|-0.87|||ANCOVA||LS mean difference between placebo and FF 110 µg QD has been presented using ANCOVA model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616911|NCT02424539|2968390|Other||Mean Difference (Final Values)|-1.23|||<|0.001|2-Sided|95.0|-1.68|-0.78|||ANCOVA||Least square (LS) mean difference between placebo and FF 55 µg QD has been presented using analysis of co-variance (ANCOVA) model adjusted for treatment, Baseline value, gender, age and type of Allergic Rhinitis.||
1616912|NCT02424383|2968397|Other||||||||||||||||||Freedom from composite of safety events from the time following the index procedure through 30 days post procedure were reported with frequency counts, percentages and 95% confidence intervals from exact binomial test. Kaplan-Meier tables and curves were also calculated.
1617136|NCT02420353|2968686|Other|mixed effects analysis||||||0.1605|||||||Mixed Models Analysis||||
1616913|NCT02424383|2968398|Other||||||||||||||||||Freedom from Target LesionRevascularization (TLR) were reported through 12 months with frequency counts, percentages and 95% confidence intervals from exact binomial test. In addition, Kaplan-Meier tables and curves were created.
1616914|NCT02424344|2968404|Superiority or Other||Least Square mean difference|-0.125||||0.069|2-Sided|95.0|-0.259|0.01|||ANCOVA|Adjusted by baseline and age as covariates, and treatment group, sex and smoking-status as fixed effect factors|||
1616915|NCT02424149|2968408|Superiority or Other|||||||0.04|||||||Fisher Exact||||
1616916|NCT02424149|2968409|Superiority or Other|||||||0.78|||||||t-test, 2 sided||||
1616917|NCT02424149|2968410|Superiority or Other|||||||1|||||||Fisher Exact||||
1616918|NCT02424149|2968411|Superiority or Other|||||||0.73|||||||t-test, 2 sided||||
1616919|NCT02424149|2968412|Superiority or Other|||||||0.77|||||||t-test, 2 sided||||
1616920|NCT02423798|2968430|Other||Mean|9.13|||||2-Sided||||||||||
1616921|NCT02423577|2968431|Superiority||Risk Ratio (RR)|1.14||||0.1436|2-Sided|90.0|0.98|1.31|||Chi-squared||||
1616922|NCT02422797|2968473|Superiority|||||||0.547||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test||||
1616923|NCT02422797|2968473|Superiority|||||||0.073||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test||||
1616924|NCT02422797|2968473|Superiority|||||||0.076||||||P-value to assess HIVTSQs General satisfaction/CS sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test||||
1616925|NCT02422797|2968473|Superiority|||||||0.004||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 48)|Wilcoxon rank sum test||||
1616926|NCT02422797|2968473|Superiority|||||||0.022||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 24)|Wilcoxon rank sum test||||
1616927|NCT02422797|2968473|Superiority|||||||0.132||||||P-value to assess HIVTSQs lifestyle/ease sub- score difference between treatment groups (Week 4)|Wilcoxon rank sum test||||
1616928|NCT02422797|2968473|Superiority|||||||0.042||||||P-value to assess HIVTSQs Total score difference between treatment groups (Week 48)|Wilcoxon rank sum test||||
1616929|NCT02422797|2968473|Superiority|||||||0.101||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 24)|Wilcoxon rank sum test||||
1616930|NCT02422797|2968473|Superiority|||||||0.037||||||P-value to assess HIVTSQs Total Score difference between treatment groups (Week 4)|Wilcoxon rank sum test||||
1616931|NCT02422797|2968476|Superiority||Mean Difference (Final Values)|-1.037||||0.164|2-Sided|95.0|-2.501|0.426||P value to assess difference between treatment groups (Symptom Bother Score - Week 48)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.||
1616932|NCT02422797|2968476|Other|||||||0.402||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 48)|ANCOVA||||
1616933|NCT02422797|2968476|Superiority||Mean Difference (Final Values)|-0.528||||0.448|2-Sided|95.0|-1.896|0.84||P value to assess difference between treatment groups (Symptom Bother Score - Week 24)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.||
1616934|NCT02422797|2968476|Other|||||||0.542||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 24)|ANCOVA||||
1616935|NCT02422797|2968476|Other||Mean Difference (Final Values)|-1.239||||0.039|2-Sided|95.0|-2.414|-0.064||P value to assess difference between treatment groups (Symptom Bother Score - Week 4)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for age, Baseline third agent, gender, race and Baseline score.||
1616936|NCT02422797|2968476|Other|||||||0.43||||||P-value for interaction between treatment group and Baseline symptom bother score (Week 4)|ANCOVA||||
1616937|NCT02422797|2968484|Other||Risk Difference (RD)|-5.4|||||2-Sided|95.0|-13.9|3.1|||||PI: No formal non-inferiority margin has been pre-specified for secondary endpoints.||
1616938|NCT02422797|2968484|Other||Risk Difference (RD)|-2.4|||||2-Sided|95.0|-12.1|7.4|||||INSTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.||
1616939|NCT02422797|2968484|Other||Risk Difference (RD)|3.5|||||2-Sided|95.0|-1.6|8.6|||||NNRTI: No formal non-inferiority margin has been pre-specified for secondary endpoints.||
1616940|NCT02422797|2968484|Other|||||||0.179||||||One-sided p-value from weighted least squares chi-squared statistic. A p-value <=0.10 was used to indicate statistically significant evidence of heterogeneity in the difference in proportions across levels of each analysis strata.|Chi-squared, Corrected||||
1616941|NCT02422797|2968497|Superiority||Odds Ratio (OR)|0.818|||<|0.001|2-Sided|95.0|0.751|0.891||P value to assess difference between treatment groups (type 1 collagen cross-linked C-telopeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616942|NCT02422797|2968497|Other||||||<|0.782||||||P-value for interaction between treatment group and Baseline third agent (type 1 collagen cross-linked C-telopeptide)|ANCOVA||||
1616943|NCT02422797|2968497|Superiority||Odds Ratio (OR)|0.743|||<|0.001|2-Sided|95.0|0.672|0.822||P value to assess difference between treatment groups (osteocalcin - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616944|NCT02422797|2968497|Superiority||Odds Ratio (OR)|0.886|||<|0.028|2-Sided|95.0|0.796|0.987||P value to assess difference between treatment groups (osteocalcin - INSTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616945|NCT02422797|2968497|Superiority||Odds Ratio (OR)|0.853|||<|0.001|2-Sided|95.0|0.799|0.91||P value to assess difference between treatment groups (osteocalcin - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616946|NCT02422797|2968497|Other||||||<|0.001||||||P-value for interaction between treatment group and Baseline third agent (osteocalcin)|ANCOVA||||
1617137|NCT02420353|2968687|Other|mixed effects model||||||0.0509|||||||Mixed Models Analysis||||
1617138|NCT02420353|2968688|Other|||||||0.1064|||||||Mixed Models Analysis||||
1616947|NCT02422797|2968497|Superiority||Odds Ratio (OR)|0.867|||<|0.001|2-Sided|95.0|0.823|0.914||P value to assess difference between treatment groups (procollagen type 1-N-propeptide)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616948|NCT02422797|2968497|Other||||||<|0.677||||||P-value for interaction between treatment group and Baseline third agent (procollagen type 1-N-propeptide)|ANCOVA||||
1616949|NCT02422797|2968497|Superiority||Odds Ratio (OR)|0.788|||<|0.001|2-Sided|95.0|0.719|0.864||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616950|NCT02422797|2968497|Superiority||Odds Ratio (OR)|0.865|||<|0.004|2-Sided|95.0|0.785|0.954||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - INSTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616951|NCT02422797|2968497|Superiority||Odds Ratio (OR)|0.728|||<|0.001|2-Sided|95.0|0.686|0.773||P value to assess difference between treatment groups (bone-specific alkaline phosphatase - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616952|NCT02422797|2968497|Other||||||<|0.001||||||P-value for interaction between treatment group and Baseline third agent (bone-specific alkaline phosphatase)|ANCOVA||||
1616953|NCT02422797|2968499|Superiority||Odds Ratio (OR)|0.877||||0.018|2-Sided|95.0|0.787|0.977||P value to assess difference between treatment groups (25 hydroxy-vitamin D - PI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616954|NCT02422797|2968499|Superiority||Odds Ratio (OR)|1.012||||0.745|2-Sided|95.0|0.943|1.085||P value to assess difference between treatment groups (25 hydroxy-vitamin D - NNRTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616955|NCT02422797|2968499|Superiority||Odds Ratio (OR)|0.861||||0.011|2-Sided|95.0|0.767|0.967||P value to assess difference between treatment groups (25 hydroxy-vitamin D - INSTI)|ANCOVA||Estimates are calculated from an ANCOVA model adjusting for Baseline third agent class, age, sex, BMI category, smoking status and Baseline biomarker level.||
1616956|NCT02422797|2968499|Other|||||||0.007||||||P-value for interaction between treatment group and Baseline third agent (25 hydroxy-vitamin D)|ANCOVA||||
1616957|NCT02422797|2968510|Other||Risk Difference (RD)|-1.1|||||2-Sided|95.0|-4.0|1.8|||||Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (< or >=50 years old) and Baseline third agent (PI, NNRTI, INSTI). No formal non-inferiority margin has been pre-specified for secondary endpoints.||
1616958|NCT02422797|2968512|Non-Inferiority|Non-inferiority can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms is greater than -10%.|Risk Difference (RD)|0.2|||||2-Sided|95.0|-3.9|4.2|||||Estimates based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factors: Age group (< or >=50 years old) and Baseline third agent (PI, NNRTI, INSTI).||
1616959|NCT02422615|2968523|Superiority||Cox Proportional Hazard|0.593||||4.1e-07|2-Sided|95.0|0.48|0.732|||Log Rank||||
1616960|NCT02422186|2968552|Other||Least Square (LS) Mean Difference|-3.6|||=|0|2-Sided|95.0|-7.16|-0.03|||ANCOVA||||
1616961|NCT02422186|2968553|Superiority||Difference of Least Square (LS) Means|-3.6|||=|0|2-Sided|95.0|-7.2|0.07|||Mixed Model for Repeated Measures||||
1616962|NCT02421939|2968559|Other||Adjusted Treatment Difference,|18.6|||<|0.0171|2-Sided|95.0|9.8|27.4||Stratified 1-sided P-value.|Cochran-Mantel-Haenszel|||"Based on a stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Pooled strata were used as shown in Table 12.3.3.2.~Treatment differences were adjusted based on pooled strata. Treatment difference = gilteritinib 120 mg – chemotherapy."|
1616963|NCT02421939|2968560|Other||Least Squares Mean Difference|0.1574||||0.8037|||||||ANCOVA|||C2D1: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.|
1616964|NCT02421939|2968560|Other||Least Squares Mean Difference|-1.2567||||0|||||||ANCOVA|||C1D8: Using analysis of covariance (ANCOVA) including treatment as a fixed factor, baseline score, response to first-line AML therapy and preselected salvage chemotherapy per IRT as covariates. Least Square (LS) Mean difference was estimated using chemotherapy as control.|
1616965|NCT02421939|2968561|Other||Treatment Difference|10.2||||0.0333|2-Sided|95.0|1.2|19.1||Unstratified 2-sided P-value.|2-sided Fisher’s exact test|Treatment difference = gilteritinib – chemotherapy.|||
1616966|NCT02421939|2968562|Other||Treatment difference|32.5|||<|0.0001|2-Sided|95.0|22.3|42.6||Unstratified 2-sided P-value|2-sided Fisher’s exact test|||Treatment difference = gilteritinib – chemotherapy. The 95% CIs were asymptotic confidence limits using the normal approximation to the binomial distribution.|
1616967|NCT02421939|2968563|Other||Hazard Ratio (HR)|0.206||||0.1189|2-Sided|95.0|0.022|1.886||Unstratified|Log Rank||Based on Cox proportional hazards model. Assuming proportional hazards, a hazard ratio < 1 indicates a reduction in hazard rate in favor of gilteritinib arm.||
1616968|NCT02421939|2968564|Other||Hazard Ratio (HR)|0.889||||0.6654|2-Sided|95.0|0.506|1.563||Unstratified p-value|Log Rank||Based on the Cox proportional hazards model. Assuming proportional hazards, an HR of < 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm.|The LFS was analyzed for participants who achieved remission using the stratified log-rank test with strata to control for response to first-line AML therapy and preselected salvage chemotherapy. Duration of LFS was based on Kaplan-Meier estimates.|
1616969|NCT02421939|2968565|Other||Adjusted Treatment Difference|10.6||||0.0106|2-Sided|95.0|2.8|18.4||Stratified P-value|Cochran-Mantel-Haenszel|||Based on stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Treatment difference = gilteritinib –chemotherapy.|
1616970|NCT02421939|2968566|Other||Hazard Ratio (HR)|0.793||||0.0415|2-Sided|95.0|0.577|1.089||1-sided P-value|Log Rank||Based on the Cox proportional hazards model. Assuming proportional hazards, an HR of < 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm.|Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT|
1616971|NCT02421939|2968568|Other||Hazard Ratio (HR)|0.637||||0.0004|2-Sided|95.0|0.49|0.83||1-sided P-value|Log Rank||Based on Cox proportional hazards model. Assuming proportional hazards, an HR of < 1 indicates a reduction in the hazard rate in favor of the gilteritinib arm|Stratified analysis where tratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT.|
1616972|NCT02421588|2968579|Superiority|||||||0.1231|||||||Fisher Exact|||ORR (%) by CA-125 between treatments|
1616973|NCT02421588|2968579|Superiority||ORR (%)|19.4|||||2-Sided|95.0|13.7|26.3|||||Percent of Participants|ORR (%) by CA-125|
1616974|NCT02421588|2968579|Superiority||ORR (%)|26.6|||||2-Sided|95.0|20.2|33.8|||||Percent of Participants|ORR (%) by CA-125|
1616975|NCT02421588|2968580|Superiority|Duration of response between treatments|Hazard Ratio (HR)|1.056||||0.8276|2-Sided|95.0|0.64|1.743|||Log Rank||||
1616976|NCT02421588|2968581|Superiority||Hazard Ratio (HR)|1.406||||0.2631|2-Sided|95.0|0.769|2.569|||Log Rank|||Duration of response between treatments|
1616977|NCT02421588|2968582|Superiority|||||||0.8976|||||||Fisher Exact|||Overall response rate (ORR) between treatments|
1616978|NCT02421588|2968582|Superiority||Overall response rate (ORR)|16.7|||||2-Sided|95.0|12.1|22.3|||||Percent of Participants|Overall response rate (ORR)|
1616979|NCT02421588|2968582|Superiority||ORR|15.8|||||2-Sided|95.0|11.3|21.3|||||Percent of Participants|Overall response rate (ORR)|
1616980|NCT02421588|2968583|Superiority|||||||0.6772|||||||Fisher Exact|||Overall response rate between treatments|
1616981|NCT02421588|2968583|Superiority||ORR|12.7|||||2-Sided|95.0|8.6|17.8|||||Percent of Participants|Overall response rate|
1616982|NCT02421588|2968583|Superiority||ORR|14.5|||||2-Sided|95.0|10.1|19.8|||||Percent of Participants|Overall response rate|
1616983|NCT02421588|2968584|Superiority|||||||0.9253|||||||Normal approximation|||OS (%) at 24 months between treatments|
1616984|NCT02421588|2968584|Superiority||OS (%) at 24 months|22.7|||||2-Sided|95.0|17.1|28.7|||||Percent of Participants|OS (%) at 24 months|
1616985|NCT02421588|2968584|Superiority||OS (%) at 24 months|22.3|||||2-Sided|95.0|16.8|28.2|||||Percent of Participants|OS (%) at 24 months|
1616986|NCT02421588|2968584|Superiority|||||||0.5515|||||||Normal approximation|||OS (%) at 12 months between treatments|
1616987|NCT02421588|2968584|Superiority||OS (%) at 12 months|45.3|||||2-Sided|95.0|38.4|52.0|||||Percent of Participants|OS (%) at 12 months|
1616988|NCT02421588|2968584|Superiority||OS at 12 months|48.2|||||2-Sided|95.0|41.3|54.8|||||Percent of Participants|OS (%) at 12 months|
1616989|NCT02421588|2968584|Superiority||Hazard Ratio (HR)|0.956||||0.8021|2-Sided|95.0|0.772|1.183|||Log Rank|||OS between treatments|
1616990|NCT02421588|2968585|Superiority|||||||0.8245|||||||Normal approximation|||PFS (%) at 12 months between treatments|
1616991|NCT02421588|2968585|Superiority||PFS (%) at 12 months|7.5|||||2-Sided|95.0|4.2|12.2|||||Percent of Participants|PFS (%) at 12 months|
1616992|NCT02421588|2968585|Superiority||PFS (%) at 12 months|8.2|||||2-Sided|95.0|4.8|12.7|||||Percent of Participants|PFS (%) at 12 months|
1616993|NCT02421588|2968585|Superiority|||||||0.7385|||||||Normal approximation|||PFS (%) at 6 months between treatments|
1616994|NCT02421588|2968585|Superiority||PFS at 6 months|27.4|||||2-Sided|95.0|21.3|33.9|||||Percent of Participants|PFS (%) at 6 months|
1616995|NCT02421588|2968585|Superiority||PFS at 6 months|29.0|||||2-Sided|95.0|22.8|35.4|||||Percent of Participants|PFS (%) at 6 months|
1616996|NCT02421588|2968585|Superiority||Hazard Ratio (HR)|0.987||||0.7673|2-Sided|95.0|0.805|1.209|||Log Rank|||PFS between treatments|
1616997|NCT02421588|2968586|Superiority|||||||0.6742|||||||Normal approximation|||PFS (%) at 12 months between treatments|
1616998|NCT02421588|2968586|Superiority||PFS at 12 months|7.0|||||2-Sided|95.0|3.3|12.5|||||Percent of Participants|PFS (%) at 12 months|
1616999|NCT02421588|2968586|Superiority||PFS at 12 months|8.3|||||2-Sided|95.0|4.7|13.3|||||Percent of Participants|PFS (%) at 12 months|
1617000|NCT02421588|2968586|Superiority|||||||0.5032|||||||Normal approximation|||PFS (%) at 6 months between treatments|
1617001|NCT02421588|2968586|Superiority||PFS at 6 months|27.5|||||2-Sided|95.0|20.9|34.4|||||Percent of Participants|PFS (%) at 6 months|
1617002|NCT02421588|2968586|Superiority||PFS at 6 months|24.3|||||2-Sided|95.0|18.4|30.7|||||Percent of Participants|PFS (%) at 6 months|
1617003|NCT02421588|2968586|Superiority||Hazard Ratio (HR)|1.057||||0.6294|2-Sided|95.0|0.854|1.309|||Log Rank|||PFS between treatments|
1617004|NCT02421510|2968588|Superiority|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-0.4|Standard Error of the Mean|0.15||0.003|2-Sided|95.0|-0.7|-0.2||Threshold for significance <= 0.05.|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (<=8.5%, >8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DDS2 total score-by-time interaction as a covariate.|
1617005|NCT02421510|2968588|Superiority|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-0.3|Standard Error of the Mean|0.15||0.025|2-Sided|95.0|-0.6|0.0||Threshold for significance <= 0.05.|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (<= 8.5%, >8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DDS2 total score-by-time interaction as a covariate.|
1617139|NCT02420353|2968689|Other|mixed effects analysis||||||0.2802|||||||Mixed Models Analysis||||
1617006|NCT02421510|2968589|Superiority|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|1.7|Standard Error of the Mean|0.36|<|0.001|2-Sided|95.0|1.0|2.4||Threshold for significance <= 0.05.|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (<= 8.5%, >8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DTSQs total score-by-time interaction as a covariate.|
1617007|NCT02421510|2968589|Superiority|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|2.0|Standard Error of the Mean|0.37|<|0.001|2-Sided|95.0|1.3|2.7||Threshold for significance <= 0.05.|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (<= 8.5%, >8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline DTSQs total score-by-time interaction as a covariate.|
1617008|NCT02421510|2968590|Superiority|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-25.7|Standard Error of the Mean|5.37|<|0.001|2-Sided|95.0|-36.2|-15.1||Threshold for significance <= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (<= 8.5%, >8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline Fasting Plasma Glucose-by-time interaction as a covariate.|
1617009|NCT02421510|2968590|Superiority|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-21.6|Standard Error of the Mean|5.38|<|0.001|2-Sided|95.0|-32.2|-11.0||Threshold for significance <= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (<= 8.5%, >8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline Fasting Plasma Glucose-by-time interaction as a covariate.|
1617010|NCT02421510|2968591|Superiority|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-3.59|Standard Error of the Mean|0.845|<|0.001|2-Sided|95.0|-5.25|-1.93||Threshold for significance <= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (<= 8.5%, >8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.|
1617011|NCT02421510|2968591|Superiority|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-3.2|Standard Error of the Mean|0.847|<|0.001|2-Sided|95.0|-4.86|-1.53||Threshold for significance <=0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (<= 8.5%, >8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and Baseline mean daily bolus insulin dose-by-time interaction as a covariate.|
1617012|NCT02421510|2968592|Superiority|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-2.58|Standard Error of the Mean|0.276|<|0.001|2-Sided|95.0|-3.12|-2.04|||MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (<= 8.5%, >8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects.|
1617013|NCT02421510|2968592|Superiority|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least squares mean difference|-1.98|Standard Error of the Mean|0.276|<|0.001|2-Sided|95.0|-2.53|-1.44||Threshold for significance <= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (<= 8.5%, >8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects.|
1617014|NCT02421510|2968593|Superiority|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Percentage difference|17.2|||<|0.001|2-Sided|95.0|10.06|24.35||Threshold for significance <= 0.05|Cochran-Mantel-Haenszel||Sotagliflozin 400 mg versus Placebo|P-values were obtained from a CMH test stratified by the different levels of the randomization stratification factors of insulin delivery method (MDI, CSII) and Week -2 A1C (<= 8.5%, >8.5%). The 95% CL were calculated using asymptotic Wald method.|
1617120|NCT02420821|2968665|Superiority||Difference in Response Rates|3.3||||0.2733|2-Sided|95.0|-3.09|9.7|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).|
1617015|NCT02421510|2968593|Superiority|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Percentage difference|16.3|||<|0.001|2-Sided|95.0|9.17|23.43||Threshold for significance <= 0.05|Cochran-Mantel-Haenszel||Sotagliflozin 200 mg versus Placebo|P-values were obtained from a Cochran–Mantel–Haenszel (CMH) test stratified by the different levels of the randomization stratification factors of insulin delivery method (MDI, CSII) and Week -2 A1C (<=8.5%, >8.5%). The 95% Confidence Limits (CL) were calculated using asymptotic Wald method. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis.|
1617016|NCT02421510|2968594|Superiority||Least squares mean difference|-0.35|||<|0.001|2-Sided|95.0|-0.47|-0.24||Threshold for significance <= 0.05|MMRM||Sotagliflozin 400 mg versus Placebo|LS means and p-values were obtained from Mixed effect Model Repeat Measurement (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (<= 8.5%, >8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C- by-time interaction as a covariate.|
1617017|NCT02421510|2968594|Superiority||Least squares mean difference|-0.37|Standard Error of the Mean|0.058|<|0.001|2-Sided|95.0|-0.48|-0.25||Threshold for significance <= 0.05|MMRM||Sotagliflozin 200 mg versus Placebo|LS means and p-values were obtained from MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week -2 A1C (<= 8.5%, >8.5%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.|
1617018|NCT02421211|2968614|Superiority or Other||LS means ratio|1.7|||||2-Sided|90.0|1.6|2.0|||||||
1617019|NCT02421211|2968615|Superiority or Other||LS means ratio|1.6|||||2-Sided|90.0|1.4|1.9|||||||
1617020|NCT02421211|2968616|Superiority or Other||LS means ratio|1.7|||||2-Sided|90.0|1.5|2.0|||||||
1617021|NCT02421211|2968617|Superiority or Other||LS means ratio|3.1|||||2-Sided|90.0|2.4|3.8|||||||
1617022|NCT02421211|2968618|Superiority or Other||LS means ratio|2.3|||||2-Sided|90.0|2.0|2.8|||||||
1617023|NCT02421211|2968619|Superiority or Other||LS means ratio|4.7|||||2-Sided|90.0|3.4|6.5|||||||
1617024|NCT02421172|2968625|Superiority or Other||Posterior probablility|0.9729|||||||||||||||
1617025|NCT02420821|2968647|Superiority||LS Mean Difference|0.52||||0.5743|2-Sided|95.0|-1.29|2.33|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617026|NCT02420821|2968647|Superiority||LS Mean Difference|0.33||||0.5537|2-Sided|95.0|-0.77|1.43|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617027|NCT02420821|2968647|Superiority||LS Mean Difference|0.62||||0.1487|2-Sided|95.0|-0.22|1.47|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617028|NCT02420821|2968647|Superiority||LS Mean Difference|0.58||||0.1078|2-Sided|95.0|-0.13|1.29|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617029|NCT02420821|2968647|Superiority||LS Mean Difference|0.55||||0.0708|2-Sided|95.0|-0.05|1.14|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617030|NCT02420821|2968647|Superiority||LS Mean Difference|0.93||||0.0011|2-Sided|95.0|0.37|1.49|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617031|NCT02420821|2968647|Superiority||LS Mean Difference|0.48||||0.0531|2-Sided|95.0|-0.01|0.96|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617032|NCT02420821|2968647|Superiority||LS Mean Difference|0.43||||0.065|2-Sided|95.0|-0.03|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617033|NCT02420821|2968647|Superiority||LS Mean Difference|0.3||||0.1378|2-Sided|95.0|-0.09|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617034|NCT02420821|2968647|Superiority||LS Mean Difference|0.67||||0.0005|2-Sided|95.0|0.29|1.05|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617035|NCT02420821|2968647|Superiority||LS Mean Difference|0.33||||0.0591|2-Sided|95.0|-0.01|0.67|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617036|NCT02420821|2968647|Superiority||LS Mean Difference|0.56||||0.0008|2-Sided|95.0|0.23|0.88|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617037|NCT02420821|2968647|Superiority||LS Mean Difference|0.52||||0.0005|2-Sided|95.0|0.23|0.82|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617038|NCT02420821|2968647|Superiority||LS Mean Difference|0.6|||<|0.0001|2-Sided|95.0|0.32|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617039|NCT02420821|2968647|Superiority||LS Mean Difference|0.42|||<|0.001|2-Sided|95.0|0.17|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617040|NCT02420821|2968647|Superiority||LS Mean Difference|0.74|||<|0.0001|2-Sided|95.0|0.49|0.99|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617041|NCT02420821|2968647|Superiority||LS Mean Difference|0.64|||<|0.0001|2-Sided|95.0|0.41|0.86|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617042|NCT02420821|2968647|Superiority||LS Mean Difference|0.74|||<|0.0001|2-Sided|95.0|0.51|0.96|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617043|NCT02420821|2968647|Superiority||LS Mean Difference|0.53|||<|0.0001|2-Sided|95.0|0.33|0.73|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617044|NCT02420821|2968647|Superiority||LS Mean Difference|0.71|||<|0.0001|2-Sided|95.0|0.52|0.91|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617121|NCT02420821|2968666|Superiority||Hazard Ratio (HR)|0.93||||0.6138|2-Sided|95.0|0.72|1.21|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).|
1617140|NCT02420353|2968690|Other|mixed effects analysis||||||0.3279|||||||Mixed Models Analysis||||
1617045|NCT02420821|2968647|Superiority||LS Mean Difference|0.49|||<|0.0001|2-Sided|95.0|0.29|0.68|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617046|NCT02420821|2968647|Superiority||LS Mean Difference|0.6|||<|0.0001|2-Sided|95.0|0.41|0.79|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617047|NCT02420821|2968647|Superiority||LS Mean Difference|0.47|||<|0.0001|2-Sided|95.0|0.29|0.66|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617048|NCT02420821|2968647|Superiority||LS Mean Difference|0.68|||<|0.0001|2-Sided|95.0|0.49|0.86|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617049|NCT02420821|2968647|Superiority||LS Mean Difference|0.47|||<|0.0001|2-Sided|95.0|0.3|0.65|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617050|NCT02420821|2968647|Superiority||LS Mean Difference|0.72|||<|0.0001|2-Sided|95.0|0.54|0.89|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617051|NCT02420821|2968647|Superiority||LS Mean Difference|0.63|||<|0.0001|2-Sided|95.0|0.46|0.8|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617052|NCT02420821|2968647|Superiority||LS Mean Difference|0.83|||<|0.0001|2-Sided|95.0|0.66|0.99|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617053|NCT02420821|2968647|Superiority||LS Mean Difference|0.65|||<|0.0001|2-Sided|95.0|0.49|0.81|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617054|NCT02420821|2968647|Superiority||LS Mean Difference|0.82|||<|0.0001|2-Sided|95.0|0.66|0.97|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617055|NCT02420821|2968647|Superiority||LS Mean Difference|0.62|||<|0.0001|2-Sided|95.0|0.46|0.78|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617056|NCT02420821|2968647|Superiority||LS Mean Difference|0.77|||<|0.0001|2-Sided|95.0|0.62|0.92|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617122|NCT02420821|2968668|Superiority||Hazard Ratio (HR)|0.88||||0.1218|2-Sided|95.0|0.74|1.04|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).|
1617141|NCT02420353|2968691|Other|mixed effects analysis||||||0.6094|||||||Mixed Models Analysis||||
1617057|NCT02420821|2968647|Superiority||LS Mean Difference|0.58|||<|0.0001|2-Sided|95.0|0.44|0.73|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617058|NCT02420821|2968647|Superiority||LS Mean Difference|0.7|||<|0.0001|2-Sided|95.0|0.55|0.84|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617059|NCT02420821|2968647|Superiority||LS Mean Difference|0.42|||<|0.0001|2-Sided|95.0|0.28|0.57|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617060|NCT02420821|2968647|Superiority||LS Mean Difference|0.73|||<|0.0001|2-Sided|95.0|0.58|0.87|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617061|NCT02420821|2968650|Superiority||LS Mean Difference|-1.07|||<|0.0001|2-Sided|95.0|-1.27|-0.88|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Diarrhea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617062|NCT02420821|2968650|Superiority||LS Mean Difference|-1.02|||<|0.0001|2-Sided|95.0|-1.28|-0.76|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Mouth/Throat Sores: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617063|NCT02420821|2968650|Superiority||LS Mean Difference|-0.05|||<|0.6541|2-Sided|95.0|-0.26|0.16|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Headache: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617064|NCT02420821|2968650|Superiority||LS Mean Difference|-1.08|||<|0.0001|2-Sided|95.0|-1.33|-0.83|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Rash/Skin Changes: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617065|NCT02420821|2968650|Superiority||LS Mean Difference|-0.34|||<|0.0051|2-Sided|95.0|-0.58|-0.1|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Numbness or tingling: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617066|NCT02420821|2968650|Superiority||LS Mean Difference|-0.58|||<|0.0001|2-Sided|95.0|-0.75|-0.41|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Vomiting: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617067|NCT02420821|2968650|Superiority||LS Mean Difference|-0.6|||<|0.0001|2-Sided|95.0|-0.87|-0.33|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Feeling sad: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617068|NCT02420821|2968650|Superiority||LS Mean Difference|-1.0|||<|0.0001|2-Sided|95.0|-1.28|-0.71|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Dry mouth: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617123|NCT02420821|2968670|Superiority||Hazard Ratio (HR)|0.68||||0.047|2-Sided|95.0|0.46|1.0|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).|
1617142|NCT02420353|2968692|Other|Mixed effects analysis||||||0.0185|||||||Mixed Models Analysis||||
1617069|NCT02420821|2968650|Superiority||LS Mean Difference|-0.54|||<|0.0001|2-Sided|95.0|-0.81|-0.27|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Drowsy: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617070|NCT02420821|2968650|Superiority||LS Mean Difference|-1.19|||<|0.0001|2-Sided|95.0|-1.46|-0.91|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Lack of appetite: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617071|NCT02420821|2968650|Superiority||LS Mean Difference|-0.33|||<|0.0036|2-Sided|95.0|-0.56|-0.11|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Remembering things: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617072|NCT02420821|2968650|Superiority||LS Mean Difference|-0.56|||<|0.0001|2-Sided|95.0|-0.81|-0.32|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Shortness of breath: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617073|NCT02420821|2968650|Superiority||LS Mean Difference|-0.56|||<|0.0001|2-Sided|95.0|-0.84|-0.29|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Feelings of being distressed: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617074|NCT02420821|2968650|Superiority||LS Mean Difference|-0.52|||<|0.0002|2-Sided|95.0|-0.79|-0.25|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Disturbed sleep: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617075|NCT02420821|2968650|Superiority||LS Mean Difference|-0.91|||<|0.0001|2-Sided|95.0|-1.13|-0.69|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Nausea: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617076|NCT02420821|2968650|Superiority||LS Mean Difference|-0.63|||<|0.0001|2-Sided|95.0|-0.91|-0.34|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Fatigue: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617077|NCT02420821|2968650|Superiority||LS Mean Difference|-0.49|||<|0.001|2-Sided|95.0|-0.77|-0.2|||Mixed Models Analysis||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Pain: Mixed-effects model, assuming unstructured covariance matrix, with a term for treatment group, a term for visit time as a continuous variable, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model. The random effects are intercept and slope of visit time.|
1617078|NCT02420821|2968651|Superiority||LS Mean Difference|0.5||||0.7725|2-Sided|95.0|-2.9|3.91|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 19 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617079|NCT02420821|2968651|Superiority||LS Mean Difference|0.22||||0.8345|2-Sided|95.0|-1.85|2.3|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617080|NCT02420821|2968651|Superiority||LS Mean Difference|0.01||||0.9914|2-Sided|95.0|-1.61|1.63|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 18 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617124|NCT02420821|2968672|Superiority||Hazard Ratio (HR)|0.81||||0.0895|2-Sided|95.0|0.63|1.03|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).|
1617143|NCT02420353|2968693|Other|Mixed effects analysis||||||0.0673|||||||Mixed Models Analysis||||
1617144|NCT02420353|2968694|Other|||||||0.0894|||||||Mixed Models Analysis||||
1617081|NCT02420821|2968651|Superiority||LS Mean Difference|0.03||||0.9663|2-Sided|95.0|-1.34|1.4|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617082|NCT02420821|2968651|Superiority||LS Mean Difference|0.38||||0.5285|2-Sided|95.0|-0.8|1.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 17 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617083|NCT02420821|2968651|Superiority||LS Mean Difference|0.02||||0.9725|2-Sided|95.0|-1.07|1.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617084|NCT02420821|2968651|Superiority||LS Mean Difference|0.08||||0.8655|2-Sided|95.0|-0.88|1.04|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 16 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617085|NCT02420821|2968651|Superiority||LS Mean Difference|-0.79||||0.0837|2-Sided|95.0|-1.69|0.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617086|NCT02420821|2968651|Superiority||LS Mean Difference|-0.15||||0.7112|2-Sided|95.0|-0.93|0.63|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 15 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617087|NCT02420821|2968651|Superiority||LS Mean Difference|-0.39||||0.3077|2-Sided|95.0|-1.13|0.36|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617088|NCT02420821|2968651|Superiority||LS Mean Difference|-0.13||||0.7088|2-Sided|95.0|-0.81|0.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 14 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617089|NCT02420821|2968651|Superiority||LS Mean Difference|-0.36||||0.2745|2-Sided|95.0|-1.01|0.29|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617090|NCT02420821|2968651|Superiority||LS Mean Difference|0.02||||0.9575|2-Sided|95.0|-0.57|0.61|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 13 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617091|NCT02420821|2968651|Superiority||LS Mean Difference|-0.76||||0.0089|2-Sided|95.0|-1.32|-0.19|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617092|NCT02420821|2968651|Superiority||LS Mean Difference|-0.5||||0.0582|2-Sided|95.0|-1.01|0.02|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 12 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617125|NCT02420821|2968674|Superiority||Hazard Ratio (HR)|0.73||||0.0205|2-Sided|95.0|0.57|0.95|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).|
1617126|NCT02420353|2968676|Other|Mixed effects model||||||0.8581|||||||Mixed Models Analysis||||
1617093|NCT02420821|2968651|Superiority||LS Mean Difference|-0.85||||0.0011|2-Sided|95.0|-1.35|-0.34|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617094|NCT02420821|2968651|Superiority||LS Mean Difference|-0.5||||0.0353|2-Sided|95.0|-0.96|-0.03|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 11 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617095|NCT02420821|2968651|Superiority||LS Mean Difference|-1.0|||<|0.0001|2-Sided|95.0|-1.46|-0.55|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617096|NCT02420821|2968651|Superiority||LS Mean Difference|-0.62|||<|0.0041|2-Sided|95.0|-1.05|-0.2|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 10 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617097|NCT02420821|2968651|Superiority||LS Mean Difference|-0.9|||<|0.0001|2-Sided|95.0|-1.32|-0.49|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617098|NCT02420821|2968651|Superiority||LS Mean Difference|-0.37|||<|0.0728|2-Sided|95.0|-0.78|0.03|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 9 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617099|NCT02420821|2968651|Superiority||LS Mean Difference|-0.65|||<|0.0014|2-Sided|95.0|-1.05|-0.25|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617100|NCT02420821|2968651|Superiority||LS Mean Difference|-0.29|||<|0.1411|2-Sided|95.0|-0.68|0.1|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 8 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617101|NCT02420821|2968651|Superiority||LS Mean Difference|-0.77|||<|0.0001|2-Sided|95.0|-1.15|-0.39|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617102|NCT02420821|2968651|Superiority||LS Mean Difference|-0.43|||<|0.0247|2-Sided|95.0|-0.8|-0.05|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 7 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617103|NCT02420821|2968651|Superiority||LS Mean Difference|-0.65|||<|0.0005|2-Sided|95.0|-1.01|-0.28|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617104|NCT02420821|2968651|Superiority||LS Mean Difference|-0.21|||<|0.2512|2-Sided|95.0|-0.56|0.15|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 6 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617127|NCT02420353|2968677|Other|mixed effects model||||||0.0208|||||||Mixed Models Analysis||||
1617128|NCT02420353|2968678|Other|mixed effects model||||||0.8581|||||||Mixed Models Analysis||||
1617129|NCT02420353|2968679|Other|mixed effects model|||||<|0.0001|||||||Mixed Models Analysis||||
1617130|NCT02420353|2968680|Other|mixed effects model||||||0.7507|||||||Mixed Models Analysis||||
1617105|NCT02420821|2968651|Superiority||LS Mean Difference|-0.78|||<|0.0001|2-Sided|95.0|-1.13|-0.44|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617106|NCT02420821|2968651|Superiority||LS Mean Difference|-0.46|||<|0.008|2-Sided|95.0|-0.8|-0.12|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 5 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617107|NCT02420821|2968651|Superiority||LS Mean Difference|-0.98|||<|0.0001|2-Sided|95.0|-1.32|-0.65|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617108|NCT02420821|2968651|Superiority||LS Mean Difference|-0.43|||<|0.0098|2-Sided|95.0|-0.76|-0.1|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 4 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617109|NCT02420821|2968651|Superiority||LS Mean Difference|-1.02|||<|0.0001|2-Sided|95.0|-1.34|-0.7|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617110|NCT02420821|2968651|Superiority||LS Mean Difference|-0.51|||<|0.0013|2-Sided|95.0|-0.82|-0.2|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 3 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617111|NCT02420821|2968651|Superiority||LS Mean Difference|-1.02|||<|0.0001|2-Sided|95.0|-1.33|-0.71|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617112|NCT02420821|2968651|Superiority||LS Mean Difference|-0.2|||<|0.2085|2-Sided|95.0|-0.51|0.11|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 2 Day 1: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617113|NCT02420821|2968651|Superiority||LS Mean Difference|-0.74|||<|0.0001|2-Sided|95.0|-1.06|-0.43|||Repeated measures model||Difference in LS mean score change between arms (Atezolizumab + Bevacizumab minus Sunitinib) was reported.|Cycle 1 Day 22: Repeated measures model, assuming 1st order autoregressive covariance structure, with a term for visit as a categorical variable, a term for treatment group, a term for treatment-by-visit interaction, baseline score and stratification factors (presence of liver metastasis, PD-L1 status, and Motzer score) included as covariates in the model.|
1617114|NCT02420821|2968652|Superiority||Hazard Ratio (HR)|0.56||||0.0323|2-Sided|95.0|0.32|0.96|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).|
1617115|NCT02420821|2968654|Superiority||Hazard Ratio (HR)|0.52||||0.002|2-Sided|95.0|0.34|0.79|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).|
1617116|NCT02420821|2968656|Superiority||Hazard Ratio (HR)|0.83||||0.0254|2-Sided|95.0|0.7|0.98|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).|
1617117|NCT02420821|2968659|Superiority||Difference in Response Rates|5.09||||0.1011|2-Sided|95.0|-1.4|11.58|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).|
1617118|NCT02420821|2968660|Superiority||Hazard Ratio (HR)|0.85||||0.0606|2-Sided|95.0|0.71|1.01|||Log Rank||Hazard ratio was estimated by Cox regression.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).|
1617119|NCT02420821|2968663|Superiority||Difference in Response Rates|1.96||||0.5121|2-Sided|95.0|-4.32|8.24|||Cochran-Mantel-Haenszel||95% CI for difference in response rates was constructed using Wald method.|Stratified Analysis: Strata were presence of liver metastases, Motzer score, PD-L1 level per interactive voice/web response system (IxRS).|
1617131|NCT02420353|2968681|Other|mixed effects model||||||0.5022|||||||Mixed Models Analysis||||
1617132|NCT02420353|2968682|Other|mixed effects model||||||0.6288|||||||Mixed Models Analysis||||
1617145|NCT02420353|2968695|Other|||||||0.7943|||||||Mixed Models Analysis||||
1617146|NCT02420353|2968696|Other|Mixed effects analysis||||||0.4852|||||||Mixed Models Analysis||||
1617147|NCT02420353|2968697|Other|Mixed effects analysis||||||0.1064|||||||Mixed Models Analysis||||
1617148|NCT02420353|2968698|Other|Mixed-model analysis||||||0.5251|||||||Mixed Models Analysis||||
1617149|NCT02420353|2968699|Other|mixed effects analysis||||||0.1331|||||||Mixed Models Analysis||||
1617150|NCT02420353|2968700|Other|Mixed effects analysis||||||0.4965|||||||Mixed Models Analysis||||
1617151|NCT02420353|2968701|Other|Mixed effects analysis||||||0.79|||||||Mixed Models Analysis||||
1617152|NCT02420353|2968702|Other|Mixed-effects model||||||0.3332|||||||Mixed Models Analysis||||
1617153|NCT02420353|2968703|Other|Mixed effects analysis||||||0.6291|||||||Mixed Models Analysis||||
1617154|NCT02420353|2968704|Other|mixed effects model||||||0.7325|||||||Mixed Models Analysis||||
1617155|NCT02420353|2968705|Other|mixed effects model||||||0.4437|||||||Mixed Models Analysis||||
1617156|NCT02420353|2968706|Other|mixed effects model||||||0.161|||||||Mixed Models Analysis||||
1617157|NCT02420353|2968707|Other|mixed effects model||||||0.6292|||||||Mixed Models Analysis||||
1617158|NCT02420353|2968708|Other|mixed effects model||||||0.0901|||||||Mixed Models Analysis||||
1617159|NCT02420353|2968709|Other|mixed effects model||||||0.7883|||||||Mixed Models Analysis||||
1617160|NCT02420353|2968710|Other|mixed effects model||||||0.0564|||||||Mixed Models Analysis||||
1617161|NCT02420353|2968711|Other|mixed effects model||||||0.8573|||||||Mixed Models Analysis||||
1617162|NCT02420353|2968712|Other|mixed effects model||||||0.45|||||||Mixed Models Analysis||||
1617163|NCT02420353|2968713|Other|mixed effects model||||||0.5586|||||||Mixed Models Analysis||||
1617164|NCT02420353|2968714|Other|mixed effects model||||||0.1576|||||||Mixed Models Analysis||||
1617165|NCT02420353|2968715|Other|mixed effects model||||||0.9271|||||||Mixed Models Analysis||||
1617166|NCT02420353|2968716|Other|Mixed effects model||||||0.6836|||||||Mixed Models Analysis||||
1617167|NCT02420353|2968717|Other|Mixed effects model||||||0.135|||||||Mixed Models Analysis||||
1617168|NCT02420353|2968718|Other|Mixed effects model||||||0.7024|||||||Mixed Models Analysis||||
1617169|NCT02420353|2968719|Other|||||||0.0498|||||||Mixed Models Analysis|||Mixed effect model|
1617170|NCT02420262|2968729|Superiority or Other||Treatment difference|-3.57|||<|0.0001|2-Sided|95.0|-4.19|-2.95|||Mixed Models Analysis||Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment difference was below 0 or equal to zero.|Body weight measurements were analysed using a linear mixed model with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline bodyweight as covariate. Interactions between visit and all factors and the covariate were also included in the model. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.|
1617171|NCT02420262|2968730|Superiority or Other||Treatment ratio|0.11|||<|0.0001|2-Sided|95.0|0.08|0.17|||Negative binomial regression model||Superiority for IDegLira vs basal-bolus was considered confirmed if the 95% confidence interval for the treatment rate ratio was entirely below 1.0.|Hypoglycaemic episodes were analysed using a negative binomial regression. The model included treatment and region as fixed factors and logarithm of the time period in which a hypoglycaemic episode considered treatment emergent as offset. The test for superiority of the confirmatory secondary endpoints was carried out only if non-inferiority of IDegLira vs basal-bolus for primary endpoint was confirmed.|
1617172|NCT02420262|2968731|Non-Inferiority or Equivalence|Non-inferiority for IDegLira vs basal-bolus (IGlar + IAsp) was considered confirmed if the upper boundary of the two-sided 95% confidence interval was strictly below 0.30% or equivalent for non-inferiority using one-sided test for null hypothesis (H0): D ≥0.30% against alternative hypothesis (HA): D <0.30% was less than or equal to 2.5%, where D is the mean treatment difference (IDegLira minus basal-bolus).|Treatment contrast|-0.02|||<|0.0001|2-Sided|95.0|-0.16|0.12|||Mixed Models Analysis|||Change from baseline in HbA1c was analysed using a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit and region as fixed factors and baseline HbA1c as covariate. Interactions between visit and all factors and the covariate were also included in the model.|
1617173|NCT02419612|2968771|Superiority||Hazard Ratio (HR)|0.15||||0.002|2-Sided|95.0|0.04|0.5||This endpoint did not meet the required number of events (n=10) in each treatment arm, hence was excluded from sequential testing.|Regression, Cox||||
1617174|NCT02419612|2968772|Superiority||Mean Difference (Final Values)|-3.6|Standard Error of the Mean|1.35||0.007|2-Sided|95.0|-6.3|-1.0|||Mixed Models Analysis|Adjusted for treatment, baseline SBP, visit, treatment-by-visit interaction, and baseline SBP-by-visit interaction|||
1617175|NCT02419612|2968773|Superiority||Odds Ratio (OR)|1.5||||0.044||95.0|1.01|2.29|||Regression, Logistic|Adjusted for baseline HbA1c value|||
1617176|NCT02419612|2968774|Superiority||Mean Difference (Final Values)|-4.06|Standard Error of the Mean|0.397|<|0.001|2-Sided|95.0|-4.84|-3.28|||Mixed Models Analysis|Adjusted for for treatment, baseline body weight, visit, treatment-by-visit interaction, and baseline body weight-by-visit interaction.|||
1617177|NCT02419612|2968775|Superiority||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.099|<|0.001|2-Sided|95.0|-0.57|-0.18|||Mixed Models Analysis|Adjusted for for treatment, baseline HbA1c, visit, treatment-by-visit interaction, and baseline HbA1c-by-visit interaction.|||
1617178|NCT02419508|2968790|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1617179|NCT02419508|2968791|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1617180|NCT02419508|2968792|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1617181|NCT02419508|2968793|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1617182|NCT02419508|2968794|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1617183|NCT02419508|2968795|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1617184|NCT02419508|2968796|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1617185|NCT02419313|2968798|Superiority or Other|||||||0.0105|||||||Fisher Exact||||
1617186|NCT02419313|2968799|Superiority or Other|||||||0.0008|||||||Fisher Exact||||
1617187|NCT02419313|2968800|Superiority or Other|||||||0.0007|||||||Fisher Exact||||
1617188|NCT02418819|2968807|Superiority or Other||LSMean difference from placebo|0.0498|Standard Error of the Mean|0.2403||0.4182|1-Sided|99.0|-0.5226||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|
1617189|NCT02418819|2968807|Superiority or Other||LSMean difference from placebo|-0.2974|Standard Error of the Mean|0.276||0.8576|1-Sided|99.0|-0.9547||||ANCOVA|One (1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|
1617190|NCT02418819|2968807|Superiority or Other||LSMean difference from placebo|0.0129|Standard Error of the Mean|0.286||0.4821|1-Sided|99.0|-0.6682||||ANCOVA|One (1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day 0 assessment.|
1617191|NCT02418819|2968808|Superiority or Other||LSMean difference from placebo|-4.01|Standard Error of the Mean|1.902||0.981|1-Sided|92.0|-6.7||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|
1617192|NCT02418819|2968808|Superiority or Other||LSMean difference from placebo|-2.14|Standard Error of the Mean|2.252||0.8277|1-Sided|92.0|-5.33||||ANCOVA|One(1)-side P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|
1617193|NCT02418819|2968808|Superiority or Other||LSMean difference from placebo|-1.9|Standard Error of the Mean|2.032||0.8243|1-Sided|92.0|-4.78||||ANCOVA|One(1)-sided P-values were obtained from an ANCOVA model on change from baseline with baseline, treatment, site, gender and age as fixed effects.||Baseline is defined as the Day -2 assessment.|
1617194|NCT02418585|2968830|Superiority||Difference of Least Square (LS) Means|-3.5|||=|0|2-Sided|95.0|-6.67|-0.26|||ANCOVA||||
1617195|NCT02418585|2968831|Superiority||Difference of Least Square (LS) Means|-4.0|Standard Error of the Mean|1.69|=|0|2-Sided|95.0|-7.31|-0.64|||Mixed Model for Repeated Measures||||
1617196|NCT02418468|2968839|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.08||0.262|2-Sided|95.0|-0.26|0.07|||mixed models for repeated measures (MMRM||||
1617197|NCT02418455|2968840|Superiority||LS Mean|-0.56|Standard Error of the Mean|0.503||0.2618|2-Sided|95.0|-1.55|0.42||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 144|
1617198|NCT02418455|2968840|Superiority||LS Mean|0.22|Standard Error of the Mean|0.364||0.5492|2-Sided|95.0|-0.5|0.93||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 96|
1617199|NCT02418455|2968840|Superiority||LS Mean|-0.15|Standard Error of the Mean|0.391||0.6954|2-Sided|95.0|-0.92|0.61||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|GEE model|||Change at Week 48|
1617200|NCT02418455|2968840|Superiority||LS Mean|-0.02|Standard Error of the Mean|0.513||0.9618|2-Sided|95.0|-1.03|0.98||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 24|
1617201|NCT02418455|2968840|Superiority||LS Mean|-0.37|Standard Error of the Mean|0.213||0.0843|2-Sided|95.0|-0.78|0.05||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 12|
1617202|NCT02418455|2968841|Superiority||LS Mean|-0.35|Standard Error of the Mean|0.255||0.1731|2-Sided|95.0|-0.85|0.15||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 144|
1617203|NCT02418455|2968841|Superiority||LS Mean|-0.57|Standard Error of the Mean|0.428||0.1792|2-Sided|95.0|-1.41|0.26||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 96|
1617204|NCT02418455|2968841|Superiority||LS Mean|-0.98|Standard Error of the Mean|0.31||0.0016|2-Sided|95.0|-1.58|-0.37||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 48|
1617205|NCT02418455|2968841|Superiority||LS Mean|-1.21|Standard Error of the Mean|0.461||0.0086|2-Sided|95.0|-2.12|-0.31||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 24|
1617206|NCT02418455|2968841|Superiority||LS Mean|-0.99|Standard Error of the Mean|0.396||0.0122|2-Sided|95.0|-1.77|-0.22||From generalized estimating equation model including baseline value and visit as a categorical variable. Change from baseline in Liver Ultrasound (cm) as a dependent variable. Covariance structure within subjects is assumed to be exchangeable.|generalized estimating equation|||Change at Week 12|
1617207|NCT02418455|2968842|Superiority|||||||0.2655|||||||t-test||||
1617208|NCT02418455|2968850|Superiority||LS Mean|-61.0|Standard Error of the Mean|6.409|<|0.0001|2-Sided|95.0|-73.56|-48.44||P-values are from generalized estimating equation (GEE) model including baseline value and visit as a categorical variable. The covariance structure within subjects is assumed to be exchangeable.|GEE model||||
1617209|NCT02418234|2968852|Superiority or Other||||||<|0.05|||||||ANOVA||||
1617210|NCT02418234|2968853|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1617211|NCT02417961|2968901|Superiority or Other||Percentage|0.2|||||2-Sided|95.0|0.0|0.97|||||Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 16)||
1617212|NCT02417961|2968901|Superiority or Other||Percentage|0.0|||||2-Sided|95.0|0.0|1.63|||||Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12 to 16)||
1617213|NCT02417961|2968901|Superiority or Other||Percentage|0.3|||||2-Sided|95.0|0.01|1.59|||||Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 0 to 8)||
1617214|NCT02417961|2968901|Superiority or Other||Percentage|0.0|||||2-Sided|95.0|0.0|3.33|||||Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 16)||
1617215|NCT02417961|2968901|Superiority or Other||Percentage|0.0|||||2-Sided|95.0|0.0|3.13|||||Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 12)||
1617216|NCT02417961|2968901|Superiority or Other||Percentage|0.0|||||2-Sided|95.0|0.0|3.16|||||Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 8)||
1617217|NCT02417961|2968901|Superiority or Other||Percentage|0.9|||||2-Sided|95.0|0.02|4.67|||||Percentage of malfunctioning APFS used to administer benralizumab at home or clinic (Week 4)||
1617218|NCT02417961|2968901|Superiority or Other||Percentage|0.0|||||2-Sided|95.0|0.0|3.13|||||Percentage of mulfunctioning APFS used to administer benralizumab at home or clinic (Week 0)||
1617219|NCT02417961|2968902|Superiority or Other||Percentage|99.1|||||2-Sided|95.0|94.99|99.98|||||Percentage of patients returned functional APFS administered at home (Week 16)||
1617220|NCT02417961|2968902|Superiority or Other||Percentage|99.1|||||2-Sided|95.0|95.21|99.98|||||Percentage of patients returned functional APFS administered at home (Week 12)||
1617221|NCT02417961|2968903|Superiority or Other||Percentage|93.0|||||2-Sided|95.0|86.64|96.92|||||Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12 and 16)||
1617222|NCT02417961|2968903|Superiority or Other||Percentage|99.1|||||2-Sided|95.0|94.99|99.98|||||Percentage of patients who successfully administered benralizumab with an APFS at home (Week 16)||
1617223|NCT02417961|2968903|Superiority or Other||Percentage|98.2||||||95.0|93.81|99.79|||||Percentage of patients who successfully administered benralizumab with an APFS at home (Week 12)||
1617224|NCT02417935|2968904|Other|||||||0.907|||||||Fisher Exact|||50% Reduction|
1617225|NCT02417935|2968904|Other|||||||0.632||||||30% reduction|Fisher Exact||||
1617226|NCT02417935|2968905|Other||Mean Difference (Final Values)|0.136||||0.503|2-Sided|95.0|-0.264|0.537|||Mixed Models Analysis||||
1617227|NCT02417935|2968906|Other||Mean Difference (Final Values)|0.005||||0.976|2-Sided|95.0|-0.355|0.366|||Mixed Models Analysis||||
1617228|NCT02417935|2968907|Other||Mean Difference (Final Values)|0.2||||0.701|2-Sided|95.0|-0.8|1.1|||Mixed Models Analysis||||
1617229|NCT02417935|2968908|Other||Mean Difference (Final Values)|0.014||||0.361|2-Sided|95.0|-0.0161|0.0441|||ANCOVA||||
1617230|NCT02417935|2968909|Other||Mean Difference (Final Values)|-0.2||||0.106|2-Sided|95.0|-0.4|0.0|||Mixed Models Analysis||||
1617231|NCT02417935|2968910|Other||Mean Difference (Final Values)|-0.1||||0.557|2-Sided|95.0|-0.5|0.3|||ANCOVA|||Paresthesia/Dysesthesia|
1617232|NCT02417935|2968910|Other||Mean Difference (Final Values)|-0.2||||0.345|2-Sided|95.0|-0.5|0.2|||ANCOVA|||Evoked Pain|
1617233|NCT02417935|2968910|Other||Mean Difference (Final Values)|0.1||||0.721|2-Sided|95.0|-0.3|0.4|||ANCOVA|||Paroxysmal Pain|
1617234|NCT02417935|2968910|Other||Mean Difference (Final Values)|0.1||||0.731|2-Sided|95.0|-0.3|0.4|||ANCOVA|||Pressing Pain|
1617235|NCT02417935|2968910|Other||Mean Difference (Final Values)|-0.2||||0.355|2-Sided|95.0|-0.6|0.2|||ANCOVA|||Burning Pain|
1617236|NCT02417935|2968910|Other||Mean Difference (Final Values)|-0.7||||0.627|2-Sided|95.0|-3.6|2.2|||ANCOVA|||Total Score|
1617237|NCT02417935|2968911|Other||Mean Difference (Final Values)|-0.16||||0.246|2-Sided|95.0|-0.44|0.11|||Mixed Models Analysis|||Average Interference Score|
1617238|NCT02417935|2968911|Other||Mean Difference (Final Values)|-0.2||||0.133|2-Sided|95.0|-0.5|0.1|||Mixed Models Analysis|||Enjoyment of life|
1617239|NCT02417935|2968911|Other||Mean Difference (Final Values)|0.0||||0.857|2-Sided|95.0|-0.3|0.3|||Mixed Models Analysis|||Sleep|
1617240|NCT02417935|2968911|Other||Mean Difference (Final Values)|-0.2||||0.233|2-Sided|95.0|-0.4|0.1|||Mixed Models Analysis|||Relations with other people|
1617241|NCT02417935|2968911|Other||Mean Difference (Final Values)|-0.2||||0.216|2-Sided|95.0|-0.5|0.1|||Mixed Models Analysis|||Normal Work|
1617242|NCT02417935|2968911|Other||Mean Difference (Final Values)|-0.1||||0.507|2-Sided|95.0|-0.4|0.2|||Mixed Models Analysis|||Walking Ability|
1617243|NCT02417935|2968911|Other||Mean Difference (Final Values)|-0.2||||0.276|2-Sided|95.0|-0.6|0.2|||Mixed Models Analysis|||Mood|
1617244|NCT02417935|2968911|Other||Mean Difference (Final Values)|-0.2||||0.225|2-Sided|95.0|-0.6|0.1|||Mixed Models Analysis|||General Activity|
1617245|NCT02417935|2968911|Other||Mean Difference (Final Values)|0.0||||0.948|2-Sided|95.0|-0.4|0.4|||Mixed Models Analysis|||Pain Right Now|
1617246|NCT02417935|2968911|Other||Mean Difference (Final Values)|0.1||||0.534|2-Sided|95.0|-0.2|0.5|||Mixed Models Analysis|||Average Pain|
1617247|NCT02417935|2968911|Other||Mean Difference (Final Values)|-0.1||||0.436|2-Sided|95.0|-0.5|0.2|||Mixed Models Analysis|||Least Pain|
1617248|NCT02417935|2968911|Other||Mean Difference (Final Values)|0.1||||0.535|2-Sided|95.0|-0.3|0.6|||Mixed Models Analysis|||Worst Pain|
1617249|NCT02417935|2968912|Other||Mean Difference (Final Values)|-0.2||||0.149|2-Sided|95.0|-0.4|0.1|||Mixed Models Analysis||||
1617250|NCT02417935|2968913|Non-Inferiority|If the upper bound of the 95% CI does not exceed 0.51 (pre-defined non-inferiority margin), it will be concluded that duloxetine is not inferior to Pregabalin.|Mean Difference (Final Values)|0.072||||0.7|2-Sided|95.0|-0.295|0.439|||Mixed Models Analysis||||
1617251|NCT02417844|2968917|Non-Inferiority or Equivalence (legacy)|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.48|Standard Deviation|14.12|||2-Sided|90.0|93.9|105.39|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."||
1617851|NCT02397785|2970652|Superiority|||||||0.3155|||||||t-test, 2 sided||||
1617252|NCT02417844|2968918|Non-Inferiority or Equivalence (legacy)|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.58|Standard Deviation|13.51|||2-Sided|90.0|94.23|105.24|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."||
1617253|NCT02417844|2968919|Non-Inferiority or Equivalence (legacy)|Bioequivalence range of 80% to 125%.|Geometric mean ratio (%)|99.66|Standard Deviation|19.15|||2-Sided|90.0|92.19|107.74|||||"The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation.~Ratio calculated as test divided by reference."||
1617254|NCT02417831|2968923|Non-Inferiority or Equivalence (legacy)|Bioequivalence range of 80% to 125%.|Ratio|101.42|Standard Deviation|8.85|||2-Sided|90.0|97.81|105.17|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.||
1617255|NCT02417831|2968924|Non-Inferiority or Equivalence (legacy)|Bioequivalence range of 80% to 125%.|Ratio|101.4|Standard Deviation|9.05|||2-Sided|90.0|97.71|105.23|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.||
1617256|NCT02417831|2968925|Non-Inferiority or Equivalence (legacy)|Bioequivalence range of 80% to 125%.|Ratio|105.76|Standard Deviation|14.18|||2-Sided|90.0|99.81|112.08|||||The standard deviation in the statistical analysis is actually the intra-individual coefficient of variation. Ratio calculated as test divided by reference.||
1617257|NCT02417246|2968967|Equivalence|A mixed effect model for repeated measures was performed to model the 24-hour HR by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|1.134||||0.368|2-Sided||||||Mixed Models Analysis||||
1617258|NCT02417246|2968967|Equivalence|A mixed effect model for repeated measures was performed to model the 24-hour HR by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|1.233||||0.333|2-Sided||||||Mixed Models Analysis||||
1617259|NCT02417246|2968968|Equivalence|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory DBP by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|-2.329||||0.068|2-Sided||||||Mixed Models Analysis||||
1617260|NCT02417246|2968968|Equivalence|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory SBP by quartile for 35 patients receiving brand name metoprolol ER and Generic A.|Slope|-2.371||||0.2|2-Sided||||||Mixed Models Analysis||||
1617261|NCT02417246|2968968|Equivalence|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory diastolic blood pressure (DBP) by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|-0.543||||0.671|2-Sided||||||Mixed Models Analysis||||
1617262|NCT02417246|2968968|Equivalence|A mixed effect model for repeated measures was performed to model the 24-hour ambulatory systolic blood pressure (SBP) by quartile for 35 patients receiving brand name metoprolol ER and Generic B.|Slope|-2.39||||0.203|2-Sided||||||Mixed Models Analysis||||
1617263|NCT02417246|2968969|Equivalence|A mixed effect model for repeated measures was used to model medication effect on HRV comparing brand name metoprolol ER to Generic A, adjusting for quartile,(quartile*med) interaction, and treatment assignment.|Slope|-0.6|Standard Error of the Mean|0.3||0.0168|2-Sided||||||Mixed Models Analysis||p for medication*quartile interaction considered significant if p<0.025.||
1617264|NCT02417246|2968969|Equivalence|A mixed effect model for repeated measures was used to model medication effect on HRV comparing brand name metoprolol ER to Generic B, adjusting for quartile, (quartile*med) interaction, and treatment assignment.|Slope|-0.7|Standard Error of the Mean|0.3||0.0858|2-Sided||||||Mixed Models Analysis||||
1617265|NCT02417246|2968970|Equivalence|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of Cmax for Generic A to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|1.12|||||2-Sided|90.0|1.02|1.23|||||||
1617266|NCT02417246|2968970|Equivalence|A paired t-test was used to compare the mean values of Cmax for brand name metoprolol ER and Generic A at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t-test, we would have >80% power to detect a 11% difference in Cmax.|Mean Difference (Final Values)|-2.5|Standard Deviation|12.6||0.3|2-Sided|95.0|-7.3|2.3|||t-test, 2 sided|Average Cmax for patients on the 50mg dose who were administered brand name metoprolol ER and Generic A were compared using a paired t-test (n=29)|||
1617267|NCT02417246|2968970|Equivalence|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of Cmax for Generic B to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|0.87|||||2-Sided|90.0|0.79|0.95|||||||
1617268|NCT02417246|2968970|Equivalence|A paired t-test was used to compare the mean values of Cmax for brand name metoprolol ER and Generic B at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t-test, we would have >80% power to detect a 11% difference in Cmax.|Mean Difference (Final Values)|2.6|Standard Deviation|10.7||0.2|2-Sided|95.0|-1.5|6.6|||t-test, 2 sided|Average Cmax for patients on the 50mg dose who were administered brand name metoprolol ER and Generic B were compared using a paired t-test (n=29)|||
1617269|NCT02417246|2968971|Equivalence|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if the 90% confidence interval for the ratio of the population geometric means of the AUC0-24 for Generic A to brand name metoprolol ER fell within 0.8 to 1.25|Geometric mean ratio|0.93|||||2-Sided|90.0|0.86|1.01|||||||
1617270|NCT02417246|2968971|Equivalence|A paired t-test was used to compare mean values of AUC0-24 for brand name metoprolol ER and Generic A at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t test, we would have >80% power to detect a 16% difference in AUC.|Mean Difference (Final Values)|7.2|Standard Deviation|176.5||0.8|2-Sided|95.0|-60.0|74.3|||t-test, 2 sided|Average AUC0-24 for patients on the 50mg dose who were administered brand name metoprolol ER and Generic A were compared using a paired t-test (n=29)|||
1617271|NCT02417246|2968971|Equivalence|A bioequivalence (BE) test was performed for patients who were administered the 50mg dose. BE was declared if 90% confidence interval for the ratio of the population geometric means of the AUC0-24 for Generic B to brand name metoprolol ER falls within 0.8 to 1.25|Geometric mean ratio|0.85|||||2-Sided|90.0|0.76|0.95|||||||
1617272|NCT02417246|2968971|Equivalence|A paired t-test was used to compare mean values of AUC0-24 for brand name metoprolol ER and Generic B at the 50mg dose. With a sample size of 38, at an alpha level of 0.025 (0.05/2 comparisons), using a 2-sided paired t test, we would have >80% power to detect a 16% difference in AUC.|Mean Difference (Final Values)|45.1|Standard Deviation|222.2||0.3|2-Sided|95.0|-41.1|131.2|||t-test, 2 sided|Average AUC from 0 to 24 hours (0-24) for patients on the 50mg dose of brand name metoprolol ER and Generic B were compared by a paired t-test (n=28)|||
1617273|NCT02417233|2968973|Other||Odds Ratio (OR)|1.764||||0.152|2-Sided|95.0|0.81|3.83|||Regression, Logistic||||
1617274|NCT02417233|2968973|Other||Odds Ratio (OR)|1.943||||0.093|2-Sided|95.0|0.9|4.21|||Regression, Logistic||||
1617275|NCT02417233|2968974|Other||Odds Ratio (OR)|2.68||||0.2|2-Sided|95.0|0.59|12.16|||Regression, Logistic||||
1617276|NCT02417233|2968974|Other||Odds Ratio (OR)|0.27||||0.24|2-Sided|95.0|0.03|2.45|||Regression, Logistic||||
1617277|NCT02417233|2968975|Other||Odds Ratio (OR)|1.82||||0.03|2-Sided|95.0|1.06|3.14|||Regression, Logistic||||
1617278|NCT02417233|2968975|Other||Odds Ratio (OR)|1.48||||0.16|2-Sided|95.0|0.86|2.55|||Regression, Logistic||||
1617279|NCT02417233|2968976|Other||Odds Ratio (OR)|1.401||||0.165|2-Sided|95.0|0.87|2.26|||Regression, Logistic||||
1617280|NCT02417233|2968976|Other||Odds Ratio (OR)|0.866||||0.636|2-Sided|96.0|0.48|1.57|||Regression, Logistic||||
1617281|NCT02417233|2968977|Other||Odds Ratio (OR)|1.492||||0.125|2-Sided|95.0|0.9|2.49|||Regression, Logistic||||
1617282|NCT02417233|2968977|Other||Odds Ratio (OR)|0.958||||0.848|2-Sided|95.0|0.62|1.49|||Regression, Logistic||||
1617283|NCT02417064|2968995|Superiority||Difference of Least Square (LS) Means|-4.1|||||2-Sided|95.0|-7.53|-0.6|||||||
1617284|NCT02417064|2968995|Superiority||Difference of Least Square (LS) Means|-2.0|||=|0|2-Sided|95.0|-5.52|1.42|||ANCOVA||||
1617285|NCT02417064|2968996|Superiority||Difference of Least Square (LS) Means|-4.1|||||2-Sided|95.0|-7.67|-0.49|||||||
1617286|NCT02417064|2968996|Superiority||Difference of Least Square (LS) Means|-3.2||||0.088|2-Sided|95.0|-6.88|0.45|||Mixed Model for Repeated Measures||||
1617287|NCT02416934|2968998|Superiority|||||||0.375||||||Fisher's Exact Test|Fisher Exact||||
1617288|NCT02416934|2968999|Superiority||Mean Difference (Final Values)|1.7874|Standard Error of the Mean|3.1273|<|0.05|2-Sided|95.0|-4.5153|8.0902|||t-test, 2 sided|||Comparing the changes in VNDI between Dexamethasone and Saline from baseline to last visit|
1617289|NCT02416934|2969000|Superiority||Mean Difference (Final Values)|-0.604|Standard Error of the Mean|0.2543|<|0.05|2-Sided|95.0|-1.1151|-0.093|||t-test, 2 sided|||Comparing Bazaz between Dexamethasone and Saline at 6 months post-op|
1617290|NCT02416934|2969000|Superiority||Mean Difference (Final Values)|-1.5392|Standard Error of the Mean|0.7176|<|0.036|2-Sided|95.0|-2.9761|-0.1022|||t-test, 2 sided|||Comparing DSQ between Dexamethasone and Saline at Day 1 post-op|
1617291|NCT02416713|2969010|Superiority||Slope|-0.16||||0.7|2-Sided|95.0|-1.0|0.69|||Mixed Models Analysis||||
1617292|NCT02416713|2969010|Superiority||relative change from baseline|-0.3||||0.49|2-Sided|95.0|-1.17|0.57|||Mixed Models Analysis||||
1617293|NCT02416713|2969010|Superiority||relative change from baseline|0.66||||0.12|2-Sided|95.0|-0.18|1.51|||Mixed Models Analysis||||
1617294|NCT02415842|2969025|Equivalence|Difference between groups (H9N2_AS minus H9N2_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|0.24|||||2-Sided|95.0|-13.76|15.0|||||||
1617295|NCT02415842|2969025|Equivalence|Difference between groups (H9N2_AS minus H9N2_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|16.67|||||2-Sided|95.0|0.35|34.76|||||||
1617296|NCT02415842|2969025|Equivalence|Difference between groups (H9N2_AS minus H9N2_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|3.33|||||2-Sided|95.0|-13.06|20.24|||||||
1617297|NCT02415842|2969026|Equivalence|Difference between groups (H5N1_AS minus H5N1_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 365.|Difference in percentage of subjects|6.9|||||2-Sided|95.0|-6.19|22.15|||||||
1617298|NCT02415842|2969026|Equivalence|Difference between groups (H5N1_AS minus H5N1_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|6.39|||||2-Sided|95.0|-11.91|24.71|||||||
1617299|NCT02415842|2969026|Equivalence|Difference between groups (H5N1_AS minus H5N1_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|36.65|||||2-Sided|95.0|11.41|57.53|||||||
1617300|NCT02415842|2969026|Equivalence|Difference between groups (H5N1_AS minus H5N1_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|27.08|||||2-Sided|95.0|5.96|47.01|||||||
1617301|NCT02415842|2969027|Equivalence|Difference between groups (H1N1_AS minus H1N1_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 182.|Difference in percentage of subjects|-6.07|||||2-Sided|95.0|-30.56|18.65|||||||
1617302|NCT02415842|2969027|Equivalence|Difference between groups (H1N1_AS minus H1N1_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 42.|Difference in percentage of subjects|12.0|||||2-Sided|95.0|-14.45|36.98|||||||
1617303|NCT02415842|2969027|Equivalence|Difference between groups (H1N1_AS minus H1N1_NAS) in percentage of subjects with at least 4-fold increase of anti-H1 stalk ELISA at Day 21.|Difference in percentage of subjects|10.79|||||2-Sided|95.0|-16.5|36.83|||||||
1617304|NCT02415842|2969028|Equivalence|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2_AS over H9N2_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.2|||||2-Sided|95.0|1.0|1.44|||||||
1617305|NCT02415842|2969028|Equivalence|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2_AS over H9N2_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.49|||||2-Sided|95.0|1.28|1.73|||||||
1617306|NCT02415842|2969028|Equivalence|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H9N2_AS over H9N2_NAS) at Day 21. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.39|||||2-Sided|95.0|1.14|1.69|||||||
1617307|NCT02415842|2969029|Equivalence|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1_AS over H5N1_NAS) at Day 385 . Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.63|||||2-Sided|95.0|1.32|2.01|||||||
1617308|NCT02415842|2969029|Equivalence|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1_AS over H5N1_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.95|||||2-Sided|95.0|1.49|2.54|||||||
1617309|NCT02415842|2969029|Equivalence|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1_AS over H5N1_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|2.16|||||2-Sided|95.0|1.54|3.03|||||||
1617310|NCT02415842|2969029|Equivalence|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H5N1_AS over H5N1_NAS) at Day 21 . Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.66|||||2-Sided|95.0|1.12|2.47|||||||
1617311|NCT02415842|2969030|Equivalence|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1_AS over H1N1_NAS) at Day 182. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|0.88|||||2-Sided|95.0|0.63|1.24|||||||
1617312|NCT02415842|2969030|Equivalence|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1_AS over H1N1_NAS) at Day 42. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.23|||||2-Sided|95.0|0.83|1.81|||||||
1617313|NCT02415842|2969030|Equivalence|Adjusted GMC ratios of anti-H1 HA stalk ELISA antibody concentration between groups (H1N1_AS over H1N1_NAS) at Day 21. Adjusted GMC = GMC adjusted for baseline concentration.|Adjusted GMC ratio|1.12|||||2-Sided|95.0|0.73|1.72|||||||
1617314|NCT02415400|2969212|Superiority||Hazard Ratio (HR)|0.86||||0.1742|2-Sided|95.0|0.7|1.07|||2-sided p-value|||Separate hierarchical testing was performed for aspirin vs placebo: 4) Superiority for all-cause death and ischemic events.|
1617315|NCT02415400|2969213|Superiority||Hazard Ratio (HR)|0.92||||0.437|2-Sided|95.0|0.75|1.13|||2-sided p-value|||Separate hierarchical testing was performed for apixaban vs VKA: 4) Superiority for all-cause death and ischemic events.|
1617316|NCT02415400|2969214|Superiority||Hazard Ratio (HR)|1.07||||0.2219|2-Sided|95.0|0.96|1.2|||2-sided p-value|||Separate hierarchical testing was performed for aspirin vs placebo: 3) Superiority for all-cause death and all-cause rehospitalization.|
1617317|NCT02415400|2969215|Superiority||Hazard Ratio (HR)|0.84||||0.0033|2-Sided|95.0|0.75|0.94|||2-sided p-value|||Separate hierarchical testing was performed for apixaban vs VKA: 3) Superiority for all-cause death and all-cause rehospitalization.|
1617318|NCT02415400|2969216|Superiority||||||<|0.0001|||||||2-sided p-value for superiority test|||Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint.|
1617319|NCT02415400|2969217|Superiority||Hazard Ratio (HR)|1.88|||<|0.0001|2-Sided|95.0|1.58|2.23|||2-sided p-value for superiority test|||Separate hierarchical testing was performed for aspirin vs placebo: 2) Superiority for the primary endpoint.|
1617320|NCT02415400|2969218|Superiority||Hazard Ratio (HR)|0.69|||<|0.0001|2-Sided|95.0|0.58|0.82|||2-sided p-value for superiority test|||Separate hierarchical testing was performed for apixaban vs VKA: 2) Superiority for the primary endpoint|
1617321|NCT02415400|2969218|Non-Inferiority|Non-Inferiority (NI) margin = 1.2|||||<|0.0001|||||||1-sided p-value for NI test|||Separate hierarchical testing was performed for apixaban vs VKA: 1) Non-inferiority for the primary endpoint.|
1617322|NCT02415127|2969229|Superiority|||||||0.5442||||||From a repeated-measures ANCOVA with fixed effects of treatment, visit, and treatment*visit with baseline score and investigative site as covariates using an unstructured covariance matrix, testing ACTIMMUNE® vs placebo.|ANCOVA|||The primary and secondary efficacy endpoints were tested in a hierarchical manner. Each endpoint was tested in sequential order and the current endpoint must have shown statistical significance (p < 0.05) prior to performing testing the next endpoint. The primary endpoint, FARS-mNeuro, was to be tested first, followed by the key secondary endpoint, ADL, followed by the other secondary endpoints, T25FW, FARS-mNeuro responder rate, and FARStot.|
1617323|NCT02414958|2969230|Superiority||Mean Difference (Final Values)|-2.3|Standard Error of the Mean|0.7||0.0006|2-Sided|99.75|-4.3|-0.3|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model MMRM includes baseline DBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1617324|NCT02414958|2969230|Superiority||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|0.7||0.0457|2-Sided|99.75|-2.7|0.0||Nominal p-value|MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For DBP, the model MMRM includes baseline DBP seated, baseline eGFR baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, treatment by visit interaction, baseline DBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1617325|NCT02414958|2969230|Superiority||Mean Difference (Final Values)|-3.7|Standard Error of the Mean|1.0||0.0003|2-Sided|99.75|-6.8|-0.6|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1617326|NCT02414958|2969230|Superiority||Mean Difference (Final Values)|-2.1|Standard Error of the Mean|1.0||0.0397|2-Sided|99.75|-5.2|1.0|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|For SBP, the model MMRM includes baseline SBP seated, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, treatment by visit interaction, baseline SBP seated by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1617375|NCT02413294|2969379|Superiority|||||||0.56|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.|
1617852|NCT02397785|2970653|Superiority|||||||0.138|||||||t-test, 2 sided||||
1617327|NCT02414958|2969231|Superiority||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.009|<|0.0001|2-Sided|99.75|-0.119|-0.062|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1617328|NCT02414958|2969231|Superiority||Mean Difference (Final Values)|-0.092|Standard Error of the Mean|0.009|<|0.0001|2-Sided|99.75|-0.121|-0.063|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline total daily insulin dose, baseline estimated eGFR, baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline total daily insulin dose by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1617329|NCT02414958|2969232|Superiority||Mean Difference (Final Values)|-19.04|Standard Error of the Mean|1.68|<|0.0001|2-Sided|99.75|-24.13|-13.95|||ANCOVA||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.|
1617330|NCT02414958|2969232|Superiority||Mean Difference (Final Values)|-16.92|Standard Error of the Mean|1.68|<|0.0001|2-Sided|99.75|-22.04|-11.81|||ANCOVA||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|The analysis of covariance (ANCOVA) model includes model includes baseline IQR of glucose, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.|
1617331|NCT02414958|2969233|Superiority||Mean Difference (Final Values)|12.87|Standard Error of the Mean|1.01|<|0.0001|2-Sided|99.75|9.81|15.93|||ANCOVA||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean||
1617332|NCT02414958|2969233|Superiority||Mean Difference (Final Values)|11.86|||<|0.0001|2-Sided|99.75|8.78|14.93|||ANCOVA||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|The analysis of covariance (ANCOVA) model includes baseline time in the target range, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects.|
1617333|NCT02414958|2969234|Superiority||Mean Difference (Final Values)|-3.27|||<|0.0001|2-Sided|99.75|-4.15|-2.39|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1617334|NCT02414958|2969234|Superiority||Mean Difference (Final Values)|-2.69|Standard Error of the Mean|0.29|<|0.0001|2-Sided|99.75|-3.57|-1.8|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline weight, baseline eGFR, baseline HbA1c as linear covariate and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline weight by visit interaction as fixed effect. An unstructured covariance structure was used to model the within-patient measurements.|
1617335|NCT02414958|2969235|Superiority||Adjusted Rate Ratio (%)|0.782||||0.118|2-Sided|97.75|0.575|1.064||Negative binomial model|MMRM||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk [days]) was used as offset.|
1617336|NCT02414958|2969235|Superiority||Adjusted Rate Ratio (%)|0.774||||0.0972|2-Sided|95.0|0.572|1.048||This is a nominal p-value.|Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 1 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk [days]) was used as offset.|
1617337|NCT02414958|2969235|Superiority||Adjusted Rate Ratio (%)|0.726||||0.048|2-Sided|97.75|0.502|1.501|||Negative binomial model||Empagliflozin 25 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk [days]) was used as offset|
1617338|NCT02414958|2969235|Superiority||Adjusted Rate Ratio (%)|0.744||||0.0623|2-Sided|97.75|0.518|1.069|||Negative binomial model||Empagliflozin 10 milligram (mg) adjusted rate/Placebo matching Empagliflozin adjusted rate.|For week 5 to 26, negative binomial model includes baseline rate of hypoglycaemia, baseline HbA1c, and baseline eGFR as linear covariates and baseline pre-existing insulin therapy and treatment as fixed effects. Log (time at risk [days]) was used as offset.|
1617339|NCT02414958|2969236|Superiority||Mean Difference (Final Values)|-0.51|||<|0.0001|2-Sided|97.5|-0.64|-0.39|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements|
1617340|NCT02414958|2969236|Superiority||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.06|<|0.0001|2-Sided|97.5|-0.65|-0.4|||MMRM||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model MMRM includes baseline HbA1c, baseline eGFR as linear covariates and baseline pre−existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.|
1617376|NCT02413294|2969380|Superiority|||||||0.67|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.|
1617539|NCT02409667|2969803|Superiority||LSM estimate|0.02||||0.0117|2-Sided|95.0|0.0|0.04|||ANCOVA|||UK|
1617341|NCT02414958|2969237|Superiority||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.06|<|0.0001|2-Sided|97.5|-0.66|-0.41|||MMRM||Mean Difference= Empagliflozin 25 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean|Model MMRM included the fixed categorical effects of treatment, pre-existing insulin therapy, visit, and treatment-by- visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline eGFR, and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.|
1617342|NCT02414958|2969237|Superiority||Mean Difference (Final Values)|-0.54|Standard Error of the Mean|0.06|<|0.0001|2-Sided|97.5|-0.66|-0.41|||Mixed effect Model Repeated Measures||Mean Difference= Empagliflozin 10 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.|Model Mixed effect Model Repeated Measures (MMRM) included the fixed categorical effects of treatment, pre-existing insulin therapy, visit , and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline HbA1c, baseline estimated glomerular filtration rate (eGFR), and baseline HbA1c-by- visit interaction. Patient was included as random effect. An unstructured covariance structure was used to model the within-patient measurements.|
1617343|NCT02414854|2969269|Superiority|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.834||||0.2599|2-Sided|95.0|0.608|1.144||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 10 of testing order.|
1617344|NCT02414854|2969270|Superiority|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.24|||<|0.0001|2-Sided|95.0|0.16|0.32||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 9 of testing order.|
1617345|NCT02414854|2969271|Superiority|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.326|||<|0.0001|2-Sided|95.0|0.234|0.454||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 8 of testing order.|
1617346|NCT02414854|2969272|Superiority|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.15|||<|0.0001|2-Sided|95.0|0.09|0.21||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 7 of testing order.|
1617347|NCT02414854|2969273|Superiority|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.402|||<|0.0001|2-Sided|95.0|0.307|0.526||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 6 of testing order.|
1617348|NCT02414854|2969274|Superiority|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|9.41|||<|0.0001|2-Sided|95.0|5.74|13.07||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis performed using MMRM model(n=954 for 300 vs placebo)with percent change from baseline in FEV1 values up to Week 12 as response variable; & treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value & baseline-by-visit interaction as covariates. Hierarchical testing procedure used to control type I error & handle multiple secondary endpoint analyses. Here, it is test no. 5 of testing order.|
1617349|NCT02414854|2969275|Superiority|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|LS Mean Difference|0.14|||<|0.0001|2-Sided|95.0|0.08|0.19||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w|Analysis was performed using MMRM model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 4 of testing order.|
1617350|NCT02414854|2969275|Superiority|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Least Square (LS) Mean Difference|0.13|||<|0.0001|2-Sided|95.0|0.08|0.18||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using mixed-effect model with repeated measures (MMRM) model with change from baseline in FEV1 values up to Week 12 as response variable; and treatment, age, sex, baseline height, region, baseline eosinophil strata, baseline ICS dose level, visit, treatment by-visit interaction, baseline FEV1 value and baseline-by-visit interaction as covariates. Here, it is test no. 2 of testing order.|
1617351|NCT02414854|2969276|Superiority|Testing according to the hierarchical testing procedure (performed only if previous outcome measures were statistically significant).|Relative risk|0.523|||<|0.0001|2-Sided|95.0|0.413|0.662||Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 3 of testing order.|
1617352|NCT02414854|2969276|Superiority|Hierarchical testing procedure was used to control type I error rate at 0.05 level. The procedure included the 2 primary outcome measures and the first 13 secondary outcome measures reported and considered 2 pair-wise comparisons: Dupilumab 200 mg q2w vs Placebo (for Dupilumab 200 mg) q2w and Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w. Testing order is specified in analysis description.|Relative risk|0.54|||<|0.0001|2-Sided|95.0|0.43|0.68||Hierarchical testing sequence performed continued only when previous outcome measures was statistically significant at 0.05. Threshold for significance at 0.05 level.|Negative binomial regression model||Dupilumab 300 mg q2w vs Placebo (for Dupilumab 300 mg) q2w|Analysis was performed using negative binomial model with total number of events onset from randomization up to Week 52 or last contact date (whichever comes earlier) as response variable; with 4 treatment groups, age, region, baseline eosinophil strata, baseline ICS dose level, number of severe exacerbation events within 1 year prior to study as covariates; and log transformed standardized observation duration as an offset variable. Here, it is test no. 1 of testing order.|
1617353|NCT02414841|2969277|Superiority|||||||0.328|||||||Chi-squared||||
1617354|NCT02414841|2969278|Superiority||Hazard Ratio (HR)|0.96||||0.932|2-Sided|95.0|0.67|1.39|||Log Rank|Weighted|Performed as sensitivity analysis||
1617355|NCT02413996|2969324|Superiority||Mean Difference (Net)|5.94|Standard Deviation|5.3||0.05|2-Sided|95.0|-4.62|16.51|||t-test, 2 sided|||Does VRRS rehabilitation is superior to the traditional one?|
1617356|NCT02413918|2969325|Superiority or Other||Mean Difference (Final Values)|-15.4|Standard Deviation|10.1|<|0.0001|2-Sided||||||t-test, 2 sided|||BISS Outcomes: Mean changes in mania for study completers were measured. The a priori hypothesis was a mean change of 50%.|
1617357|NCT02413918|2969325|Superiority or Other||Mean Difference (Final Values)|-14.9|Standard Deviation|20.0|<|0.0094|2-Sided|||||p value is not adjusted for multiple comparisons (see above). A priori threshold for significance was p<0.05.|t-test, 2 sided|||BISS Outcomes: Mean changes in depression and mania for study completers were measured. The a priori hypothesis was a mean change of 50%.|
1617358|NCT02413879|2969326|Superiority||||||<|0.001|||||||McNemar||||
1617359|NCT02413879|2969328|Superiority||||||<|0.001|||||||McNemar||||
1617360|NCT02413580|2969345|Other|The hypothesis test is to test the null hypothesis: H0: μd = 0 versus alternative hypothesis Ha: μd ≠ 0 where μd is the mean change from Baseline to Day 14. The Shapiro-Wilk test is used to test the normality. If the assumptions for parametric test are met, a paired t-test (comparison between the pre- and post-treatment) is used to test for the treatment effect. Otherwise, a non-parametric test (Wilcoxon signed rank test) is used.|Mean Difference (Final Values)|-6.4|||<|0.001|2-Sided|95.0|-7.957|-4.787|||Paired t-test||||
1617361|NCT02413463|2969352|Superiority||||||<|0.01||||||This is the calculated p-value for the intraoperative time in the Augmented Group Vs. Faden Group|t-test, 2 sided||||
1617362|NCT02413463|2969353|Superiority|||||||0.03||||||This is the calculated p-value for the postoperative angle disparity in the Augmented Group Vs. Faden Group|t-test, 2 sided||||
1617363|NCT02413463|2969354|Superiority|||||||0.02||||||This is the calculated p-value for the postoperative angle of deviation without spectacles for near in Augmented recession vs. Faden group (Second row)|t-test, 2 sided||||
1617364|NCT02413463|2969355|Superiority|||||||0.22||||||This is the calculated p-value for the postoperative angle of deviation with spectacles for distance in Augmented recession vs. Faden group (First row)|t-test, 2 sided||||
1617365|NCT02413463|2969356|Superiority|Chi-square test||||||0.18||||||This is the calculated p-value for the success rate in the Augmented Group Vs. Faden Group|Chi-squared|||An estimation of sample size was performed considering a study power of 0.8 with an alpha error of 0.05 aiming to detect a difference of 5 Δ in the postoperative angle disparity between the 2 groups, assuming a postoperative standard deviation of 6 Δ. Based on this estimation, a total of 24 eyes were found to be adequate in each group, and considering a 25% dropout during the follow-up, recruitment of 30 study subjects in each group was targeted|
1617366|NCT02413398|2969357|Superiority||Mean Difference (Final Values)|-3.1|Standard Error of the Mean|1.6|<|0.05|2-Sided|95.0|-6.3|0.0|||Mixed Models Analysis|||Difference in adjusted mean change from baseline vs. placebo (MMRM)|
1617367|NCT02413398|2969358|Superiority||Mean Difference (Final Values)|-16.59|Standard Error of the Mean|5.15||0.001|2-Sided|95.0|-26.73|-6.45|||Mixed Models Analysis|||Difference in adjusted mean change from baseline versus placebo (MMRM)|
1617368|NCT02413398|2969359|Superiority||Mean Difference (Final Values)|-1.43|Standard Error of the Mean|0.37|<|0.001|2-Sided|95.0|-2.15|-0.69|||Mixed Models Analysis|||Difference in adjusted mean percent change from baseline (MMRM)|
1617369|NCT02413398|2969360|Superiority||Mean Difference (Final Values)|-0.34|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.53|-0.15|||Mixed Models Analysis|||Difference in adjusted mean change from baseline (MMRM model)|
1617370|NCT02413372|2969374|Superiority||Mean Difference (Final Values)|-3.85||||0.0084|2-Sided|90.0|-6.47|-1.23|||t-test, 1 sided||mean difference in adjusted change from baseline vs placebo|Day 112|
1617371|NCT02413372|2969374|Superiority||Mean Difference (Final Values)|-5.43||||0.0004|2-Sided|90.0|-8.01|-2.84|||t-test, 1 sided||mean difference in adjusted change from baseline vs placebo|Day 112|
1617372|NCT02413372|2969374|Superiority||Mean Difference (Final Values)|-5.19|||||2-Sided|90.0|-7.14|-3.25|||||mean difference in adjusted change from baseline vs placebo|Day 57|
1617373|NCT02413372|2969374|Superiority||Mean Difference (Final Values)|-7.17|||||2-Sided|90.0|-9.09|-5.26|||||mean difference in adjusted change from baseline vs placebo|Day 57|
1617374|NCT02413294|2969378|Superiority|||||||0.82|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.|
1617377|NCT02413294|2969381|Superiority|||||||0.28|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.|
1617378|NCT02413294|2969382|Superiority||||||<|0.01|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.|
1617379|NCT02413294|2969383|Superiority|||||||0.46|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.|
1617380|NCT02413294|2969384|Superiority|||||||0.4|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.|
1617381|NCT02413294|2969385|Superiority|||||||0.81|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.|
1617382|NCT02413294|2969386|Superiority|||||||0.94|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.|
1617383|NCT02413294|2969387|Superiority|||||||0.65|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.|
1617384|NCT02413294|2969388|Superiority|||||||0.65|||||||Paired T test, 2-sided|||Pre-intervention period means are compared to intervention period means for all subjects.|
1617385|NCT02413294|2969389|Superiority|||||||1|||||||Fisher Exact|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.|
1617386|NCT02413294|2969390|Superiority|||||||0.65|||||||Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.|
1617387|NCT02413294|2969391|Superiority|||||||0.42|||||||Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.|
1617388|NCT02413294|2969392|Superiority|||||||0.37||||||This t-test analyzes the change in mean between the midpoint interview immediately prior to the start of the intervention and the follow-up interview at the conclusion of the intervention.|Paired T test, 2-sided|||The analysis, like the measures themselves, tracks the significance of the change from end of pre-intervention period to end of intervention period, so while only a single comparison group is listed, because it is all one population group, there are two sets of data for that group.|
1617389|NCT02413255|2969393|Other||Estimated Ratio|1.225|||||2-Sided|90.0|0.844|1.778|||||||
1617390|NCT02413255|2969393|Other||Estimated Ratio|1.105|||||2-Sided|90.0|0.761|1.604|||||||
1617391|NCT02413255|2969393|Other||Estimated Ratio|1.055|||||2-Sided|90.0|0.701|1.587|||||||
1617392|NCT02413255|2969393|Other||Estimated Ratio|0.982|||||2-Sided|90.0|0.676|1.425|||||||
1617393|NCT02413255|2969393|Other||Estimated Ratio|1.156|||||2-Sided|90.0|0.796|1.678|||||||
1617394|NCT02413255|2969393|Other||Estimated Ratio|1.121|||||2-Sided|90.0|0.772|1.628|||||||
1617395|NCT02413255|2969409|Superiority||||||<|0.0001|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.|||
1617396|NCT02413255|2969416|Equivalence|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0846||||0.224|2-Sided|90.0|0.969|1.2002|||Power Model||||
1617397|NCT02413255|2969417|Equivalence|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0188||||0.49|2-Sided|90.0|0.9734|1.0642|||Power Model||||
1617398|NCT02413255|2969418|Equivalence|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0897||||0.201|2-Sided|90.0|0.9735|1.206|||Power Model||||
1617399|NCT02413255|2969419|Equivalence|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0799||||0.003|2-Sided|90.0|1.0371|1.1227|||Power Model||||
1617400|NCT02413255|2969422|Equivalence|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0929||||0.144|2-Sided|90.0|0.9878|1.198|||Power Model|||Day 9|
1617401|NCT02413255|2969422|Equivalence|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0789||||0.258|2-Sided|90.0|0.9628|1.195|||Power Model|||Day 1|
1617402|NCT02413255|2969423|Equivalence|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0606||||0.019|2-Sided|90.0|1.0187|1.1026|||Power Model||||
1617403|NCT02413255|2969424|Superiority|||||||0.4056|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||Day 9|
1617404|NCT02413255|2969424|Superiority|||||||0.7824|||||||ANOVA|Statistical analysis results were obtained using ANOVA with dose level as a fixed effect.||Day 1|
1617405|NCT02413255|2969425|Superiority|||||||0.5402|||||||ANOVA|Statistical analysis results were obtained using Analysis of Variance (ANOVA) with dose level as a fixed effect.|||
1617406|NCT02413255|2969426|Equivalence|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.09||||0.114|2-Sided|90.0|0.9962|1.1838|||Power Model|||Day 9|
1617407|NCT02413255|2969426|Equivalence|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.1124||||0.126|2-Sided|90.0|0.9913|1.2336|||Power Model|||Day 1|
1617496|NCT02411578|2969612|Superiority|||||||0.49|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617408|NCT02413255|2969427|Equivalence|Dose proportionality is declared when the 90% confidence interval of the slope lies entirely within the critical region (0.9679, 1.0321) for the dose range of 0.1 mg to 105 mg.|Slope|1.0195||||0.465|2-Sided|90.0|0.9752|1.0637|||Power Model||||
1617409|NCT02413229|2969436|Superiority|||||||0.0325|||||||Cochran-Mantel-Haenszel||||
1617410|NCT02413229|2969436|Superiority|||||||0.389|||||||Cochran-Mantel-Haenszel||||
1617411|NCT02413229|2969436|Superiority|||||||0.5224|||||||Cochran-Mantel-Haenszel||||
1617412|NCT02413229|2969436|Superiority|||||||0.3571|||||||Cochran-Mantel-Haenszel||||
1617413|NCT02413008|2969468|Other|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Change in maturation value from baseline to week 12|
1617414|NCT02413008|2969468|Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Change in maturation value from baseline to week 3|
1617415|NCT02413008|2969469|Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in total score of signs between week 12 and baseline|
1617416|NCT02413008|2969469|Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change in total score of signs between week 3 and baseline|
1617417|NCT02413008|2969470|Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12|
1617418|NCT02413008|2969470|Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3|
1617419|NCT02413008|2969471|Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 12|
1617420|NCT02413008|2969471|Other||||||<|0.13|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 3|
1617421|NCT02413008|2969472|Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa betweeen baseline and week 12|
1617422|NCT02413008|2969472|Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Changes in dryness of the mucosa between baseline and week 3|
1617423|NCT02413008|2969473|Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Changes in total score of symptoms of vaginal atrophy from baseline to week 12|
1617424|NCT02413008|2969473|Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Changes in total score of symptoms of vaginal atrophy from baseline to week 3|
1617425|NCT02413008|2969474|Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Changes in vaginal dryness from baseline to week 12|
1617426|NCT02413008|2969474|Other||||||<|0.14|||||||Wilcoxon (Mann-Whitney)|||Changes in vaginal dryness from baseline to week 3|
1617427|NCT02413008|2969475|Other|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12|
1617428|NCT02413008|2969475|Other|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3|
1617429|NCT02413008|2969476|Other|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Changes in dyspareunia from baseline to week 12|
1617430|NCT02413008|2969476|Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Changes in dyspareunia from baseline to week 3|
1617431|NCT02413008|2969477|Other|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||Change in pH between baseline and week 12|
1617432|NCT02413008|2969477|Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Change in pH between baseline and week 3|
1617433|NCT02413008|2969478|Other|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 12|
1617434|NCT02413008|2969478|Other|||||||0.175|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 8|
1617435|NCT02413008|2969478|Other|||||||0.642|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 3|
1617436|NCT02413008|2969478|Other|||||||0.418|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estrona from baseline to week 1|
1617437|NCT02413008|2969479|Other|||||||0.163|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estradiol from baseline to week 12|
1617438|NCT02413008|2969479|Other|||||||0.523|||||||Wilcoxon (Mann-Whitney)|||Change in plasma levels of estradiol from baseline to week 8|
1617439|NCT02413008|2969479|Other|||||||0.523|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3 in plasma levels of estradiol.|
1617440|NCT02413008|2969479|Other|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 1 in plasma levels of estradiol.|
1617441|NCT02413008|2969480|Other|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 12 in plasma levels of estriol|
1617442|NCT02413008|2969480|Other|||||||0.588|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 8 in plasma levels of estriol|
1617443|NCT02413008|2969480|Other|||||||0.649|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 3 in plasma levels of estriol|
1617444|NCT02413008|2969480|Other|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to week 1 in plasma levels of estriol|
1617445|NCT02413008|2969481|Other|||||||0.135|||||||Wilcoxon (Mann-Whitney)|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 12|
1617446|NCT02413008|2969481|Other||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 8|
1617447|NCT02413008|2969481|Other||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 3|
1617448|NCT02413008|2969481|Other||||||>|0.05|||||||Dunn Test|||Change in serum levels of Luteinizing hormone (LH) from baseline to week 1|
1617449|NCT02413008|2969482|Other||||||>|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 8|
1617450|NCT02413008|2969482|Other||||||<|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 3|
1617451|NCT02413008|2969482|Other||||||<|0.05|||||||Dunn Test|||Variation in serum levels of FSH at week 1|
1617452|NCT02413008|2969483|Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)||||
1617453|NCT02413008|2969483|Other|The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).||||||0.413|||||||Wilcoxon (Mann-Whitney)|||The variations in the intensities for each one of the symptoms and signs of the vaginal atrophy, after 3 and 12 weeks, in each treatment arm, will be compared using the non-parametric test Mann-Whitney-Wilcoxon.|
1617497|NCT02411578|2969613|Superiority|||||||0.09|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617454|NCT02413008|2969483|Other|The primary endpoint, the variation of FSH between week 12 and baseline and also comparing by arm will be analyzed using a non-parametric test (Mann-Whitney-Wilcoxon test).||||||0.1|||||||Wilcoxon (Mann-Whitney)|||"The variations of the levels of FSH after treatment was studied in each women at baseline, week 3 and week12 weeks, the variation of levels between two arms were analysed using a non-parametric test Mann-Whitney-Wilcoxon.~The intra individual variation (differences between the pre study determinations screening and baseline) was compared to the variation between baseline and the values obtained at every study visit."|
1617455|NCT02412878|2969486|Superiority||Hazard Ratio (HR)|0.82||||0.1326|2-Sided|95.0|0.578|1.164|||Log Rank|One-sided unstratified log-rank test|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using an unstratified Cox proportional hazards model.||
1617456|NCT02412878|2969486|Superiority||Hazard Ratio (HR)|0.8||||0.107|2-Sided|95.0|0.563|1.138||Progression-free survival, overall response, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Log Rank|One-sided stratified log-rank test, stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using a Cox proportional hazards model stratified by the randomization stratification factors.||
1617457|NCT02412878|2969487|Superiority||Hazard Ratio (HR)|0.72||||0.0033|2-Sided|95.0|0.567|0.913|||Log Rank|One-sided unstratified log-rank test|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using an unstratified Cox proportional hazards model.||
1617458|NCT02412878|2969487|Superiority||Hazard Ratio (HR)|0.693||||0.0014|2-Sided|95.0|0.544|0.883||Progression-free survival, overall response rate, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Log Rank|One-sided stratified log-rank test, stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Hazard ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was estimated using a Cox proportional hazards model stratified by the randomization stratification factors.|To ensure proper control of type I error, analysis of PFS was performed under a group sequential design framework with the stopping boundaries constructed using the Lan-DeMets spending function with an O'Brien-Fleming approach. The inferential comparison between the 2 treatment groups for PFS used the 1-sided log-rank test stratified by the randomization stratification factors. A 1-sided p-value was compared against the prespecified adjusted alpha value of 0.011 to determine significance.|
1617459|NCT02412878|2969488|Superiority||Odds Ratio (OR)|2.466|||<|0.0001|2-Sided|95.0|1.707|3.563|||Fisher Exact||Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method.||
1617460|NCT02412878|2969488|Superiority||Odds Ratio (OR)|2.485|||<|0.0001|2-Sided|95.0|1.716|3.598||Progression-free survival, overall response, and overall survival were tested using a fixed sequence hierarchical testing procedure to control the family-wise type I error rate below one-sided 0.025 level.|Cochran-Mantel-Haenszel|One-sided p-value from CMH test stratified by the randomization factors (ISS stage at study entry, refractory to bortezomib treatment, and age).|Odds ratio (once weekly carfilzomib 20/70 mg/m²/ twice weekly carfilzomib 20/27 mg/m²) was calculated using the Mantel-Haenszel method stratified by the randomization stratification factors.||
1617461|NCT02412852|2969489|Other|ANOVA to compare differences from baseline to completion of testing.||||||0.93|||||||ANOVA||||
1617462|NCT02412852|2969490|Other|A 3 by 3 Analysis of Variance with one between-subjects factor (Combined placebo, 40 mg TV1001, or 80 mg TV1001) and one within-subjects factor (Visit 1, Visit 2, or Visit 3) was performed for HbA1c values.||||||0.36|||||||ANOVA||||
1617463|NCT02412852|2969491|Other|The composite conduction measure and the composite velocity measure were analyzed using an Analysis of Variance with one between-subjects factor (Group: combined placebo, 40 mg TV1001, and 80 mg TV1001); and one within-subjects factor (Visit: Visit 1, Visit 2, and Visit 3).||||||0.15|||||||ANOVA||||
1617464|NCT02412852|2969492|Other|ANOVA on only those subjects who completed testing.||||||0.05||||||The results were analyzed using an ANOVA with one between-subjects factor (Group: both placebo groups combined, 40 mg TV1001sr, and 80 mg TV1001sr); and one within-subjects factor (Visit: Visit 1, Visit 2, and Visit 3).|ANOVA|The means of the three groups were further analyzed using a post hoc comparison procedure (the Scheffé test).|||
1617465|NCT02412852|2969494|Other||||||||||||||||||]The pharmacokinetics data are particularly sparse, and therefore substantial interpolations and imputations were required to produce an analyzable data set. Consequently, while not ideal, the Last Observation Carried Forward method was used for these data. There was a large amount of missing data which required imputation to determine results. The large amount of interpolations and imputations required for the pharmacokinetic analysis means that the pharmacokinetic results will need to be interpreted with caution. 3 X 3 Analysis of Variance used to compare Placebo to the two active groups. Missing data required imputation of available data.
1617466|NCT02412722|2969501|Superiority||Geometric Mean Ratio|0.92|||||2-Sided|90.0|0.67|1.26|||||||
1617467|NCT02412722|2969502|Superiority||Geometric Mean Ratio|1.12|||||2-Sided|90.0|0.75|1.68|||||||
1617468|NCT02412722|2969503|Superiority||Geometric Mean Ratio|1.07|||||2-Sided|90.0|0.78|1.47|||||||
1617469|NCT02412722|2969507|Superiority||Geometric Mean Ratio|1.04|||||2-Sided|90.0|0.72|1.49|||||||
1617470|NCT02412722|2969508|Superiority||Geometric Mean Ratio|0.9|||||2-Sided|90.0|0.59|1.36|||||||
1617471|NCT02412722|2969509|Superiority||Geometric Mean Ratio|0.59|||||2-Sided|90.0|0.46|0.76|||||||
1617498|NCT02411578|2969614|Superiority|||||||0.21|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617499|NCT02411578|2969615|Superiority|||||||0.78|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617500|NCT02411578|2969616|Superiority|||||||0.95|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617540|NCT02409667|2969803|Superiority||LSM estimate|0.01||||0.0861|2-Sided|95.0|0.0|0.02|||ANCOVA|||Germany|
1617472|NCT02412488|2969538|Other|"The goal of the primary study objective was to estimate the rate of untoward events associated with Reveal LINQ insertions performed in the out-of-cathlab setting through 3-months within a desired level of precision. The target sample size of approximately 200 subjects undergoing Reveal LINQ insertion was selected to ensure that the upper 95% confidence interval would be within 3 percentage points of the point estimate of the untoward event rate assuming the underlying rate was 2%"|Event Rate expressed as a percent|0.0|||||2-Sided|95.0|0.0|2.1|||||The estimate is the observed rate of untoward events expressed as a percentage. The 95% confidence interval is also expressed as a percentage|"There was no formal statistical hypothesis test associated with the primary outcome measure. Rather the goal of the primary study objective was to estimate the rate of untoward events associated with Reveal LINQ insertions performed in the out-of-cathlab setting through 3-months within a desired level of precision."|
1617473|NCT02412111|2969576|Superiority||Least square mean difference|-5.8|||=|0|2-Sided|95.0|-10.7|-0.9|||Mixed models Repeated Measures (MMRM)||||
1617474|NCT02412111|2969577|Superiority||Least square mean difference|2.8|||=|0|2-Sided|95.0|-0.8|6.4|||Mixed models Repeated Measures (MMRM)||||
1617475|NCT02412111|2969578|Superiority||Least square mean difference|0.8|||=|0|2-Sided|95.0|-1.0|2.6|||Mixed models Repeated Measures (MMRM)||||
1617476|NCT02412111|2969579|Superiority||Least Square (LS) mean difference|0.3|||=|0|2-Sided|95.0|-0.8|1.4|||Mixed Model for Repeated Measures (MMRM)||||
1617477|NCT02412098|2969582|Other||GLSM Ratio (%)|71.06|||||2-Sided|90.0|44.59|113.25|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 Cmax.|
1617478|NCT02412098|2969582|Other||GLSM Ratio (%)|76.24|||||2-Sided|90.0|50.65|114.77|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 Cmax.|
1617479|NCT02412098|2969583|Other||GLSM Ratio (%)|102.06|||||2-Sided|90.0|83.03|125.45|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine Cmax.|
1617480|NCT02412098|2969583|Other||GLSM Ratio (%)|66.55|||||2-Sided|90.0|53.33|83.04|||||A 90% CI was constructed for the GLSM ratio of Cmax in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine Cmax.|
1617481|NCT02412098|2969584|Other||GLSM Ratio (%)|73.52|||||2-Sided|90.0|47.83|113.02|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.||
1617482|NCT02412098|2969584|Other||GLSM Ratio (%)|80.82|||||2-Sided|90.0|45.11|144.79|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|ANOVA appropriate for a parallel design was fit to the natural logarithmic transformation of GS-623134 AUCinf.|
1617483|NCT02412098|2969585|Other||GLSM Ratio (%)|127.8|||||2-Sided|90.0|73.57|222.01|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|An analysis of variance (ANOVA) appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine AUCinf.|
1617484|NCT02412098|2969585|Other||Geometric Least Square Mean (GLSM) Ratio|73.54|||||2-Sided|90.0|41.92|129.01|||||A 90% CI was constructed for the GLSM ratio of AUCinf in the hepatic impairment group versus matched control.|An analysis of variance (ANOVA) appropriate for a parallel design was fit to the natural logarithmic transformation of eleclazine AUCinf.|
1617485|NCT02411929|2969588|Superiority or Other||Ratio|110.71|||||||||||||The ratio (Test/Reference) of the geometric means of dose normalized natural log transformed Total 14^C in Urine will be estimated. Total 14^C_Urine_IV is the Reference formulation and Total 14C_Urine_Oral is the Test formulation (expressed as a %).|Ratio - Test (Oral) / Reference (IV) (%)|
1617486|NCT02411929|2969598|Superiority or Other||Test (oral)/Reference (IV) of means|104.73|||||2-Sided|90.0|101.64|107.91|||||Natural log transformed AUCinf(dn) and AUClast(dn) from Period 1 were analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences were exponentiated.|Ratio - Test (oral) / Reference (IV) of means|
1617487|NCT02411747|2969599|Non-Inferiority or Equivalence|Beta: 0.8, p significant if p > 0.005||||||0.34|||||||t-test, 2 sided|||Independent samples t-test|
1617488|NCT02411578|2969604|Superiority|||||||0.08||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis||||
1617489|NCT02411578|2969605|Superiority|||||||0.66||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis||||
1617490|NCT02411578|2969606|Superiority|||||||0.93||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis||||
1617491|NCT02411578|2969607|Superiority|||||||0.7|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617492|NCT02411578|2969608|Superiority|||||||0.13|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617493|NCT02411578|2969609|Superiority|||||||0.8|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617494|NCT02411578|2969610|Superiority|||||||0.41|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617495|NCT02411578|2969611|Superiority|||||||0.63|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617536|NCT02410200|2969770|Superiority or Other|||||||0.009|||||||Wilcoxon Signed Rank test||||
1617501|NCT02411578|2969617|Superiority|||||||0.86|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617502|NCT02411578|2969618|Superiority|||||||0.02|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617503|NCT02411578|2969619|Superiority|||||||0.01|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617504|NCT02411578|2969620|Superiority|||||||0.34|||||||Mixed Models Analysis|Analyzed with generalized linear mixed model with an identity link. Due to violations of normality, rank transformations were used in model.|||
1617505|NCT02411578|2969621|Superiority|||||||0.99||||||Proportions of successes in each arm were compared using a generalized linear mixed model with a logistic link function, random participant effect to account for correlated data from some pts having multiple events, and adjustment for baseline BG.|Mixed Models Analysis|||For the crossover trial primary analysis, analyzed events were study treatment events meeting the following criteria: a) a survey was completed in the smart phone application, b) the initial BG measurement was 40 to 69 mg/dL, c) BG measurements were performed at both the 15-minute (in a window of 13 to 20 minutes) and 30-minute (28 to 40 minutes) time points, and d) appropriate treatment including dose was taken both at the initial and 15-minute time points.|
1617506|NCT02411539|2969661|Superiority|Assuming that a common standard deviation of change (measured as difference of log10 transformed HIV-1 RNA/DNA ratios) in both arms was 0.30, with a sample size of 36 evaluable participants (18 in each arm), the study had 88% power to detect an effect size of 0.30 log10 (2-fold) in change of cell-associated HIV-1 RNA/DNA from baseline to week 6 using a two-sided Wilcoxon rank sum test at 10% type I error rate assuming a normal distribution||||||0.16||||||Two-sided Wilcoxon rank sum test at 10% significance level. Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The primary efficacy analysis compared the change in cell-associated HIV-1 RNA/DNA ratio (log-transformed) from baseline to week 6 between the two randomized arms, testing the null hypothesis of no difference in changes in cell-associated HIV-1 RNA/DNA ratio between the two arms using a Wilcoxon rank sum test at 10% significance level.|
1617507|NCT02411448|2969670|Other||Hazard Ratio (HR)|0.619||||0.0003|2-Sided|95.0|0.477|0.805|||Log Rank||||
1617508|NCT02411448|2969671|Other|||||||1|||||||Cochran-Mantel-Haenszel||||
1617509|NCT02411448|2969672|Other|||||||0.7413|||||||Cochran-Mantel-Haenszel||||
1617510|NCT02411448|2969673|Other||Hazard Ratio (HR)|0.832||||0.4209|2-Sided|95.0|0.532|1.303|||Log Rank||||
1617511|NCT02411448|2969675|Other||Hazard Ratio (HR)|0.591|||<|0.0001|2-Sided|95.0|0.461|0.76|||Log Rank||||
1617512|NCT02411396|2969678|Other|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Odds Ratio (OR)|2.24|||||2-Sided|95.0|1.84|2.72|||||VOC in patients with SCD whom went to ICs represents the numerator, VOC in patients with SCD whom went to EDs represents the denominator for Odds Ratio.||
1617513|NCT02411396|2969679|Other|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Odds Ratio (OR)|5.14|||||2-Sided|95.0|4.13|6.41|||||VOC in patients with SCD whom went to EDs represents the numerator, VOC in patients with SCD whom went to ICs represents the denominator for Odds Ratio.||
1617514|NCT02411396|2969680|Other|In order to eliminate bias from the naïve estimation on the treatment effects due to the confounders, time varying propensity score model was developed. This balanced the covariates between the two arms at each single acute visit of each patient. A sub classification on the propensity scores was used to estimate the potential outcome for each arm and the average treatment effects (ATE). Bootstrapping was employed to estimate the standard error of ATE.|Mean Difference (Final Values)|124.6|Standard Error of the Mean|3.2|||2-Sided|95.0|118.3|130.9||||||This analysis is to compare outcome measure between ED or IC visits by using time varying propensity score method developed by our group to adjust imbalance of covariates between the two arms. Each patient can have multiple visits to the facility of choice.|
1617515|NCT02411110|2969690|Superiority or Other||Least Squares Mean Difference|0.34||||0.505|||||||ANCOVA|Baseline value as a covariate; treatment group and stratification (age: < 40 or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or > 6) as factors.|LiRIS® - Placebo||
1617516|NCT02410278|2969749|Superiority|||||||0.2604|||||||Chi-squared||||
1617517|NCT02410278|2969750|Superiority|||||||1|||||||Fisher's Exact||||
1617518|NCT02410278|2969751|Superiority|||||||1|||||||Chi-squared||||
1617519|NCT02410278|2969752|Superiority||adjusted mean difference|0.129||||0.2469|2-Sided|95.0|-0.092|0.349|||Repeated measures model|||Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight (kg) and baseline GSRS score, and has unstructured variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and Day 3.|
1617520|NCT02410278|2969753|Superiority||adjusted mean difference|0.082||||0.054|2-Sided|95.0|-0.001|0.166|||Repeated measures model|||Change from Day 1 to Week 8: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.|
1617537|NCT02409667|2969802|Superiority||LSM estimate|-0.03||||0.2203|2-Sided|95.0|-0.07|0.02|||ANCOVA|||UK|
1617538|NCT02409667|2969802|Superiority||LSM estimate|-0.02||||0.1852|2-Sided|95.0|-0.05|0.01|||ANCOVA|||Germany|
1617521|NCT02410278|2969753|Superiority||adjusted mean difference|0.088||||0.0479|2-Sided|95.0|0.001|0.176|||Repeated measures model|||Change from Day 1 to Week 7: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.|
1617522|NCT02410278|2969753|Superiority||adjusted mean difference|0.088||||0.0649|2-Sided|95.0|-0.006|0.182|||Repeated measures model|||Change from Day 1 to Week 6: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.|
1617523|NCT02410278|2969753|Superiority||adjusted mean difference|0.1||||0.0509|2-Sided|95.0|0.0|0.201|||Repeated measures model|||Change from Day 1 to Week 5: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.|
1617524|NCT02410278|2969753|Superiority||adjusted mean difference|0.1||||0.0866|2-Sided|95.0|-0.015|0.216|||Repeated measures model|||Change from Day 1 to Week 4: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.|
1617525|NCT02410278|2969753|Superiority||adjusted mean difference|0.085||||0.1788|2-Sided|95.0|-0.04|0.211|||Repeated measures model|||Change from Day 1 to Week 3: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.|
1617526|NCT02410278|2969753|Superiority||adjusted mean difference|0.079||||0.2677|2-Sided|95.0|-0.063|0.221|||Repeated measures model|||Change from Day 1 to Week 2: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.|
1617527|NCT02410278|2969753|Superiority||adjusted mean difference|0.115||||0.1743|2-Sided|95.0|-0.052|0.283|||Repeated measures model|||Change from Day 1 to Week 1: Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight(kg) and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and the specified time point.|
1617528|NCT02410278|2969754|Superiority||Hazard Ratio (HR)|0.946||||0.8328|2-Sided|95.0|0.563|1.589|||Regression, Cox|||Hazard ratio and the P-value are based on the Cox's proportional hazard regression model, adjusted for age, weight and baseline GSRS score. Hazard ratio (HR) is the ratio of hazard rates of Montelukast and placebo treatment groups. P-value is from the Wald test that HR is 1. CI = Wald confidence interval.|
1617529|NCT02410278|2969755|Superiority||Hazard Ratio (HR)|1.094||||0.7952|2-Sided|95.0|0.554|2.164|||Regression, Cox|||Hazard ratio and the P-value are based on the Cox's proportional hazard regression model, adjusted for age, weight and baseline GSRS score. Hazard ratio (HR) is the ratio of hazard rates of Montelukast and placebo treatment groups. P-value is from the Wald test that HR is 1. CI = Wald confidence interval.|
1617530|NCT02410278|2969756|Superiority||adjusted mean difference|0.081||||0.0376|2-Sided|95.0|0.005|0.158|||Repeated measures model|||Results are obtained from a repeated measures model for change from baseline (Day 0) in the GSRS score. The model includes treatment, day and treatment by day interaction, adjusted for age, weight and baseline GSRS score, and has spatial-exponential variance-covariance structure. The P-value is for testing the null hypothesis of no difference between the two treatment groups in the average change from baseline (Day 0) between Day 1 and Week 10.|
1617531|NCT02410278|2969757|Superiority||adjusted mean difference|0.084||||0.3753|2-Sided|95.0|-0.104|0.273|||ANCOVA|||Results are obtained from an ANCOVA model for comparing average change of the GSRS score in the two treatment groups, adjusted for age, weight and baseline GSRS score. Weights, defined as the proportions of days with GSRS score recorded during the Day 1 – Day 10 period are applied to adjust for missing data.|
1617532|NCT02410278|2969758|Superiority||Odds Ratio (OR)|3.931||||0.0617|2-Sided|95.0|0.938|20.832|||weighted logistic regression model|||Odds ratio is the odds of an event in the Montelukast treatment group divided by the odds of an event in the placebo treatment group. P-value is from the likelihood ratio test that the odds ratio is 1. CI = profile likelihood confidence interval.|
1617533|NCT02410252|2969759|Other||%|84.0||||0.05|2-Sided||||||descriptive analysis|||Descriptive statistics were used to characterize the study sample, and survey responses. All analysis was conducted using STATA version 14.2 with an alpha of 0.05 set a priori. Since this was an exploratory study with descriptive statistics, a complete case analysis approach was adopted for this study|
1617534|NCT02410252|2969760|Other||%|0.29||||0.13|2-Sided|||||Significance was set at p<0.05|Cochran-Mantel-Haenszel|||"GAD-7 scores were coded as a categorical variable as follows: mild anxiety (total score 0 to 5) and moderate/ severe anxiety (total score 6-15).~Proportion of participants with mild and moderate/ severe anxiety at enrollment and closeout was compared using Cochran’s Q test."|
1617535|NCT02410252|2969761|Other||%|100.0|||||2-Sided|||||||||Descriptive statistics were used to characterize the study sample, and survey responses.|
1617541|NCT02409667|2969804|Superiority||LSM estimate|-2.31||||0.2823|2-Sided|95.0|-6.55|1.92|||ANCOVA||||
1617542|NCT02409667|2969805|Superiority||LSM estimate|2.22||||0.0027|2-Sided|95.0|0.77|3.68|||ANCOVA||||
1617543|NCT02409667|2969806|Superiority||LSM estimate|0.75||||0.0203|2-Sided|95.0|0.12|1.39|||ANCOVA|||Scaling|
1617544|NCT02409667|2969806|Superiority||LSM estimate|0.19||||0.6136|2-Sided|95.0|-0.56|0.94|||ANCOVA|||Itching|
1617545|NCT02409667|2969806|Superiority||LSM estimate|0.17||||0.6457|2-Sided|95.0|-0.57|0.92|||ANCOVA|||Pain|
1617546|NCT02409667|2969807|Superiority||LSM estimate|-0.31||||0.0003|2-Sided|95.0|-0.48|-0.14|||ANCOVA|||Scaling|
1617547|NCT02409667|2969807|Superiority||LSM estimate|-0.38||||0.0001|2-Sided|95.0|-0.57|-0.18|||ANCOVA|||Itching|
1617548|NCT02409667|2969807|Superiority||LSM estimate|-0.13||||0.1219|2-Sided|95.0|-0.3|0.04|||ANCOVA|||Pain|
1617549|NCT02409667|2969808|Superiority||LSM estimate|1.7||||0.5674|2-Sided|95.0|-4.16|7.56|||ANCOVA|||Work productivity loss|
1617550|NCT02409667|2969808|Superiority||LSM estimate|-0.61||||0.6139|2-Sided|95.0|-6.31|10.61|||ANCOVA|||Total activity impairment|
1617551|NCT02409667|2969808|Superiority||LSM estimate|0.63||||0.8619|2-Sided|95.0|-6.59|7.85|||ANCOVA|||Presenteeism|
1617552|NCT02409667|2969808|Superiority||LSM estimate|1.2||||0.4156|2-Sided|95.0|-1.71|4.11|||ANCOVA|||Absenteeism|
1617553|NCT02409667|2969809|Superiority||LSM estimate|-1.08||||0.0758|2-Sided|95.0|-2.28|0.11|||ANCOVA||||
1617554|NCT02409667|2969809|Superiority||LSM estimate|-0.61||||0.5499|2-Sided|95.0|-2.59|1.38|||ANCOVA|||Total activity impairment|
1617555|NCT02409667|2969809|Superiority||LSM estimate|-0.67||||0.2971|2-Sided|95.0|-1.93|0.59|||ANCOVA|||Presenteeism|
1617556|NCT02409667|2969809|Superiority||LSM estimate|-0.97||||0.2101|2-Sided|95.0|-2.48|0.55|||ANCOVA|||Absenteeism|
1617557|NCT02409667|2969810|Superiority||LSM estimate|1.17||||0.0675|2-Sided|95.0|-0.09|2.42|||ANCOVA||||
1617558|NCT02409667|2969811|Superiority||LSM estimate|-0.62||||0.0001|2-Sided|95.0|-0.93|-0.31|||ANCOVA||||
1617559|NCT02409667|2969812|Superiority||LSM estimate|1.47||||0.009|2-Sided|95.0|0.37|2.57|||ANCOVA|||Week 52|
1617560|NCT02409667|2969812|Superiority||LSM estimate|1.17||||0.024|2-Sided|95.0|0.16|2.18|||ANCOVA|||Week 48|
1617561|NCT02409667|2969812|Superiority||LSM estimate|0.54||||0.3189|2-Sided|95.0|-0.52|1.59|||ANCOVA|||Week 44|
1617562|NCT02409667|2969812|Superiority||LSM estimate|0.75||||0.1157|2-Sided|95.0|-0.19|1.68|||ANCOVA|||Week 40|
1617563|NCT02409667|2969812|Superiority||LSM estimate|0.62||||0.1202|2-Sided|95.0|-0.16|1.41|||ANCOVA|||Week 36|
1617564|NCT02409667|2969812|Superiority||LSM estimate|0.79||||0.0287|2-Sided|95.0|0.08|1.5|||ANCOVA|||Week 32|
1617565|NCT02409667|2969812|Superiority||LSM estimate|0.4||||0.174|2-Sided|95.0|-0.18|0.99|||ANCOVA|||Week 28|
1617566|NCT02409667|2969813|Superiority||LSM mean|-0.59||||0|2-Sided|95.0|-0.81|-0.36|||ANCOVA||||
1617567|NCT02409667|2969813|Superiority||LSM estimate|-0.49||||0|2-Sided|95.0|-0.7|-0.27|||ANCOVA|||Week 48|
1617568|NCT02409667|2969813|Superiority||LSM estimate|-0.3||||0.0001|2-Sided|95.0|-0.45|-0.15|||ANCOVA|||Week 44|
1617569|NCT02409667|2969813|Superiority||LSM estimate|-0.25||||0.0005|2-Sided|95.0|-0.38|-0.11|||ANCOVA|||Week 40|
1617570|NCT02409667|2969813|Superiority||LSM estimate|-0.24||||0.0001|2-Sided|95.0|-0.37|-0.12|||ANCOVA|||Week 36|
1617571|NCT02409667|2969813|Superiority||LSM estimate|-0.09||||0.1073|2-Sided|95.0|-0.19|0.02|||ANCOVA|||Week 32|
1617572|NCT02409667|2969813|Superiority||Least square mean (LSM) estimate|-0.09||||0.0489|2-Sided|95.0|-0.18|0.0|||ANCOVA|||Week 28|
1617573|NCT02409667|2969816|Superiority||Odds Ratio (OR)|0.62||||0.1013|2-Sided|95.0|0.35|1.1|||Regression, Logistic||||
1617574|NCT02409667|2969817|Non-Inferiority|The statistical null-hypothesis to be rejected in the primary analysis was that the odds ratio of maintaining a PASI 90 response for patients with secukinumab 4-weekly dosing versus patients on secukinumab 6-weekly dosing exceeds the non-inferiority margin of 1+δ.|Odds Ratio (OR)|1.91||||0.1499|2-Sided|95.0|1.44|2.55|||Regression, Logistic||||
1617575|NCT02408965|2969845|Superiority|||||||0.02|||||||Chi-squared||||
1617576|NCT02408965|2969846|Superiority|||||||0.03|||||||Chi-squared||||
1617577|NCT02408965|2969847|Superiority||||||<|0.001|||||||Chi-squared||||
1617578|NCT02408965|2969848|Superiority|||||||0.07|||||||Chi-squared||||
1617579|NCT02408965|2969849|Superiority|||||||0.06|||||||Chi-squared||||
1617580|NCT02408965|2969850|Superiority|||||||0.06|||||||Chi-squared||||
1617581|NCT02408965|2969851|Superiority|||||||0.04|||||||Chi-squared||||
1617582|NCT02408965|2969852|Superiority|||||||0.02|||||||t-test, 2 sided||||
1617583|NCT02408965|2969853|Superiority|||||||0.5|||||||Chi-squared||||
1617584|NCT02408523|2969858|Superiority||Hazard Ratio (HR)|0.683|||=|0|2-Sided|95.0|0.507|0.921||Wald's method was used to calculate the p-value, Hazard Ratio (HR) and confidence intervals (CIs).|Regression, Cox|||Comparison of LCM versus Placebo was based on a Cox proportional hazards regression model with an effect for treatment, stratifying for the following combinations of study participants’ Baseline PGTCS frequency and Development from interactive response technology (IRT) (<= 2 per 28 days in the Combined Baseline Period and Pediatric, <= 2 per 28 days in the Combined Baseline Period and Adult, and > 2 per 28 days in the Combined Baseline Period). The reference group was Placebo.|
1617585|NCT02408523|2969859|Superiority||KM seizure free of LCM vs Placebo|14.1|||=|0|2-Sided|95.0|3.2|25.1||Superiority of LCM vs Placebo p-value was based on a chi-square test on 1 degree of freedom.|Mantel Haenszel||Stratified difference in proportion of subjects who are seizure-free from PGTCS on Lacosamide (FAS) vs Placebo (FAS).|The key secondary efficacy variable was evaluated using an extended Mantel-Haenszel testing procedure. Baseline PGTCS Frequency from Combined Baseline and development (age from interactive response technology (IRT)) were calculated from IRT.|
1617630|NCT02404493|2970257|Superiority or Other||||||<|0.003||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617586|NCT02408523|2969860|Superiority||Hazard Ratio (HR)|0.54|||<|0.001|2-Sided|95.0|0.377|0.774||Wald's method was used to calculate the p-value, Hazard Ratio (HR) and confidence intervals (CIs).|Regression, Cox|||Comparison of LCM versus Placebo was based on a Cox proportional hazards regression model with an effect for treatment, stratifying for the following combinations of study participants’ Baseline PGTCS frequency and Development from interactive response technology (IRT) (<= 2 per 28 days in the Combined Baseline Period and Pediatric, <= 2 per 28 days in the Combined Baseline Period and Adult, and > 2 per 28 days in the Combined Baseline Period). The reference group was Placebo.|
1617587|NCT02408315|2969883|Non-Inferiority|Estimates obtained from Kaplan-Meier method and results of Log-rank test. P-value for non-inferiority hypothesis based on Cox proportional hazards model (H0: HR ≤ 0.74 vs. HA: HR > .74), p-value < .05 provides evidence to reject inferiority and conclude BM is non-inferior to VM.||||||0.663|||||||Cox proportional||||
1617588|NCT02408068|2969888|Superiority or Other||Median Difference (Final Values)|3.5||||0.0014|2-Sided|95.0|2.25|4.38|||Wilcoxon (Mann-Whitney)||||
1617589|NCT02408068|2969889|Superiority or Other||Geometric LSmean ratio|118.83|||||2-Sided|90.0|111.58|126.54|||||||
1617590|NCT02408068|2969890|Superiority or Other||Geometric LSmean ratio|83.27|||||2-Sided|90.0|75.58|91.74|||||||
1617591|NCT02408068|2969891|Superiority or Other||Median Difference (Final Values)|2.25||||0.0005|2-Sided|95.0|1.25|3.75|||Wilcoxon (Mann-Whitney)||||
1617592|NCT02408068|2969892|Superiority or Other||Geometric LSmean ratio|108.33|||||2-Sided|90.0|102.3|114.72|||||||
1617593|NCT02408068|2969893|Superiority or Other||Geometric LSmean ratio|77.56|||||2-Sided|90.0|70.89|84.86||||||Results obtained using a mixed effects ANOVA with fixed effects for study period, sequence, treatment and subject (sequence) (excl. tmax).|
1617594|NCT02407236|2969977|Superiority||Adjusted treatment difference|17.9|||<|0.001|2-Sided|95.0|8.6|27.2|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 2|
1617595|NCT02407236|2969977|Superiority||Adjusted treatment difference|15.1|||<|0.002|2-Sided|95.0|6.0|24.2|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 1|
1617596|NCT02407236|2969978|Superiority||Adjusted treatment difference|19.7|||<|0.001|2-Sided|95.0|10.3|29.0|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 2|
1617597|NCT02407236|2969978|Superiority||Adjusted treatment difference|14.5|||<|0.002|2-Sided|95.0|5.5|23.6|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.|Statistical Analysis 1|
1617598|NCT02407236|2969979|Superiority||Adjusted treatment difference|12.7|||<|0.001|2-Sided|97.5|7.0|18.4|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 2|
1617599|NCT02407236|2969979|Superiority||Adjusted treatment difference|10.3|||<|0.001|2-Sided|97.5|4.8|15.8|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 1|
1617600|NCT02407236|2969980|Superiority||Adjusted treatment difference|10.2|||<|0.001|2-Sided|95.0|5.6|14.8|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 2|
1617601|NCT02407236|2969980|Superiority||Adjusted treatment difference|10.3|||<|0.001|2-Sided|95.0|5.7|14.9|||Cochran-Mantel-Haenszel||Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.|Statistical Analysis 1|
1617602|NCT02407132|2969996|Superiority|||||||0.326||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.|
1617603|NCT02407132|2969997|Superiority|||||||0.147||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.|
1617604|NCT02407132|2969998|Superiority|||||||0.957||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.|
1617605|NCT02407132|2969999|Superiority|||||||0.622||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.|
1617606|NCT02407132|2970000|Superiority|||||||0.312||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed Effects Logistic Regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.|
1617853|NCT02397785|2970654|Superiority|||||||0.7456|||||||t-test, 2 sided||||
1617607|NCT02407132|2970001|Superiority|||||||0.04||||||The p-value above represents results of analysis of the between-arm changes in probability of performing the self-care behavior from baseline to 12 months post-intervention. Analyses do not include imputed values.|Mixed effects logistic regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||To facilitate interpretation of regression coefficients, estimates obtained in the logit scale (log odds) were transformed into probability scale.|
1617608|NCT02407132|2970002|Superiority|||||||0.186||||||The p-value above reflects results of between-arms analysis of mean change in HDL from baseline to immediate post-intervention. 6 months between-arms p-value=0.009; 12 months between-arms p-value=0.201. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean HDL (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.|
1617609|NCT02407132|2970003|Superiority|||||||0.019||||||The p-value above reflects results of between-arms analysis of change in mean total chol from baseline to immediate post-intervention. 6 months between-arms p-value=0.598; 12 months between-arms p-value=0.073. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean Total Cholesterol (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.|
1617610|NCT02407132|2970004|Superiority|||||||0.234||||||The p-value above reflects results of between-arms analysis of change in mean BMI from baseline to immediate post-intervention. 6 months between-arms p-value = 0.552; 12 months between-arms p-value = 0.447. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean BMI from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.|
1617611|NCT02407132|2970005|Superiority|||||||0.038||||||The p-value above reflects results of between-arms analysis of mean change in HbA1c from baseline to immediate post-intervention. 6 months between-arms p-value = 0.139; 12 months between-arms p-value = 0.013. Analyses do not include imputed values.|Linear mixed effects regression|Adjusted for baseline sex, age, education, marital status, employment, use of diabetes medication, and households containing multiple participants.||The outcome variable for these analyses is Change in mean HbA1c from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention.|
1617612|NCT02406677|2970023|Superiority||Odds Ratio (OR)|2.035|||<|0.0001|2-Sided|95.0|1.564|2.649|||Regression, Logistic|Logistic regression with GEE to account for within hospital clustering|||
1617613|NCT02406677|2970024|Superiority||Odds Ratio (OR)|0.838||||0.026|2-Sided|95.0|0.717|0.979|||Regression, Logistic|Logistic regression model with parameters estimated using GEE to account for within hospital clustering for selected patient characteristics|||
1617614|NCT02406677|2970025|Superiority||Hazard Ratio (HR)|1.073||||0.3503|2-Sided|95.0|0.925|1.246|||Regression, Cox|Cox proportional hazards model accounting for within hospital clustering using robust standard errors|Usual Care arm is the reference group||
1617615|NCT02406443|2970072|Superiority||Mean Difference (Final Values)|5.7||||0.42|2-Sided||||||Regression, Linear||||
1617616|NCT02406443|2970073|Superiority||Mean Difference (Final Values)|2.4|||<|0.001|2-Sided||||||Regression, Linear||||
1617617|NCT02406443|2970074|Superiority||Mean Difference (Final Values)|0.5|||<|0.001|2-Sided||||||Regression, Linear||||
1617618|NCT02406443|2970075|Superiority||Mean Difference (Final Values)|22.0||||0.15|2-Sided||||||Regression, Linear||||
1617619|NCT02406443|2970076|Superiority||Median Difference (Final Values)|5.7||||0.4|2-Sided||||||Regression, Linear||||
1617620|NCT02406443|2970077|Superiority||Mean Difference (Final Values)|46.0|||=|0|2-Sided||||||Regression, Linear||||
1617621|NCT02405962|2970108|Superiority||Adjusted Incidence Rate Ratio|0.2|||<|0.05|2-Sided|95.0|0.08|0.53|||Mixed Models Analysis||||
1617622|NCT02405195|2970137|Other||||||<|0.001||||||Bonferroni–Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA|
1617623|NCT02405195|2970138|Other|||||||0.972||||||Bonferroni–Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA|
1617624|NCT02405195|2970139|Other|||||||0.638||||||Bonferroni–Holm adjustment for multiple comparisons was used|ANOVA|||Repeated measures ANOVA throughout measurement period (before, during and after CPB).|
1617625|NCT02404493|2970256|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.242||0.571|2-Sided|95.0|-0.65|0.37||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617626|NCT02404493|2970256|Superiority or Other|||||||0.004||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617627|NCT02404493|2970256|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617628|NCT02404493|2970257|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.228||0.767|2-Sided|95.0|-0.41|0.547||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617629|NCT02404493|2970257|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617854|NCT02397785|2970655|Superiority|||||||0.0723|||||||t-test, 2 sided||||
1617631|NCT02404493|2970258|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.194||0.932|2-Sided|95.0|-0.391|0.424||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617632|NCT02404493|2970258|Superiority or Other|||||||0.012||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617633|NCT02404493|2970258|Superiority or Other|||||||0.006||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617634|NCT02404493|2970259|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.33||0.711|2-Sided|95.0|-0.607|0.857||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617635|NCT02404493|2970259|Superiority or Other|||||||0.058||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617636|NCT02404493|2970259|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617637|NCT02404493|2970260|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.31||0.699|2-Sided|95.0|-0.824|0.574||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617638|NCT02404493|2970260|Superiority or Other|||||||0.08||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617639|NCT02404493|2970260|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617640|NCT02404493|2970261|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.19||0.027|2-Sided|95.0|-0.931|-0.069||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617641|NCT02404493|2970261|Superiority or Other|||||||0.182||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617642|NCT02404493|2970261|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617643|NCT02404493|2970262|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.24||0.317|2-Sided|95.0|-0.778|0.278||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617644|NCT02404493|2970262|Superiority or Other|||||||0.169||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617645|NCT02404493|2970263|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.19||0.334|2-Sided|95.0|-0.214|0.6||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617646|NCT02404493|2970263|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617647|NCT02404493|2970263|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617648|NCT02404493|2970264|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.24||0.991|2-Sided|95.0|-0.509|0.514||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617649|NCT02404493|2970264|Superiority or Other|||||||0.025||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617650|NCT02404493|2970264|Superiority or Other|||||||0.004||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617755|NCT02402218|2970460|Superiority|||||||0.33|||||||Chi-squared|||changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.|
1617651|NCT02404493|2970265|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.27||0.682|2-Sided|95.0|-0.672|0.449||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617652|NCT02404493|2970265|Superiority or Other|||||||0.076||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617653|NCT02404493|2970265|Superiority or Other|||||||0.055||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617654|NCT02404493|2970266|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.2||0.539|2-Sided|95.0|-0.531|0.286||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617655|NCT02404493|2970266|Superiority or Other|||||||0.363||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617656|NCT02404493|2970266|Superiority or Other|||||||0.58||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617657|NCT02404493|2970267|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.188||0.926|2-Sided|95.0|-0.41|0.375||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617658|NCT02404493|2970267|Superiority or Other|||||||0.051||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617659|NCT02404493|2970267|Superiority or Other|||||||0.007||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617660|NCT02404493|2970268|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.351||0.06|2-Sided|95.0|-1.435|0.032||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617661|NCT02404493|2970268|Superiority or Other|||||||0.821||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617662|NCT02404493|2970268|Superiority or Other|||||||0.005||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617663|NCT02404493|2970269|Superiority or Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.231||0.518|2-Sided|95.0|-0.635|0.331||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617664|NCT02404493|2970269|Superiority or Other|||||||0.223||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617665|NCT02404493|2970269|Superiority or Other|||||||0.017||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617666|NCT02404493|2970270|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.18||0.492|2-Sided|95.0|-0.25|0.502||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617667|NCT02404493|2970270|Superiority or Other|||||||0.541||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617668|NCT02404493|2970270|Superiority or Other|||||||0.692||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617669|NCT02404493|2970271|Superiority or Other||Mean Difference (Final Values)|134.9|Standard Error of the Mean|79.567||0.107|2-Sided|95.0|-32.266|302.063||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617670|NCT02404493|2970271|Superiority or Other|||||||0.06||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617756|NCT02402218|2970462|Superiority|||||||0.22|||||||Chi-squared||||
1617855|NCT02397785|2970656|Superiority|||||||0.2556|||||||Sign test||||
1617671|NCT02404493|2970271|Superiority or Other|||||||0.002||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617672|NCT02404493|2970272|Superiority or Other||Mean Difference (Final Values)|194.0|Standard Error of the Mean|68.461||0.011|2-Sided|95.0|50.712|337.291||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617673|NCT02404493|2970272|Superiority or Other|||||||0.22||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617674|NCT02404493|2970272|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617675|NCT02404493|2970273|Superiority or Other||Mean Difference (Final Values)|221.97|Standard Error of the Mean|100.674||0.04|2-Sided|95.0|11.254|432.68||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617676|NCT02404493|2970273|Superiority or Other|||||||0.26||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617677|NCT02404493|2970273|Superiority or Other|||||||0.002||||||The significance level threshold level was 0.05.|One-sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617678|NCT02404493|2970274|Superiority or Other||Mean Difference (Final Values)|167.95|Standard Error of the Mean|48.21||0.002|2-Sided|95.0|67.046|268.854||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617679|NCT02404493|2970274|Superiority or Other|||||||0.271||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617680|NCT02404493|2970274|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617681|NCT02404493|2970275|Superiority or Other||Median Difference (Final Values)|52.3|Standard Error of the Mean|19.21||0.013|2-Sided|95.0|12.23|92.373||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617682|NCT02404493|2970275|Superiority or Other|||||||0.754||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617683|NCT02404493|2970275|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617684|NCT02404493|2970276|Superiority or Other||Mean Difference (Final Values)|422.81|Standard Error of the Mean|122.905||0.003|2-Sided|95.0|166.435|679.186||The significance level threshold level was 0.05.|ANCOVA|Change from baseline as response, baseline score as covariate and treatment as factor.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1617685|NCT02404493|2970276|Superiority or Other|||||||0.023||||||The significance level threshold level was 0.05.|One sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617686|NCT02404493|2970276|Superiority or Other||||||<|0.001||||||The significance level threshold level was 0.05.|One-sample t-test|||The null hypothesis was no difference between the baseline score and the post-baseline score. The alternative hypothesis was a difference between the baseline score and the post-baseline score.|
1617687|NCT02404389|2970282|Non-Inferiority or Equivalence|p value is provided|Mean Difference (Net)|0.0|Standard Deviation|0.07||0.517|2-Sided|90.0|-0.12|0.13|||posterior mean||||
1617688|NCT02404389|2970282|Non-Inferiority or Equivalence|p value is provided|Mean Difference (Net)|0.0|Standard Deviation|0.07||0.515|2-Sided|90.0|-0.12|0.12|||Posterior mean||||
1617689|NCT02404350|2970284|Superiority||Odds Ratio (OR)|0.24|||<|0.0001|2-Sided|95.0|0.13|0.44|||Regression, Logistic||||
1617690|NCT02404350|2970284|Superiority||Odds Ratio (OR)|0.34|||<|0.0003|2-Sided|95.0|0.19|0.6|||Regression, Logistic||||
1617691|NCT02404350|2970284|Superiority||Odds Ratio (OR)|0.37|||<|0.0004|2-Sided|95.0|0.22|0.65|||Regression, Logistic||||
1617692|NCT02404350|2970285|Superiority||Odds Ratio, log|0.44||||0.0004|2-Sided|95.0|0.28|0.69|||Regression, Logistic||||
1617693|NCT02404350|2970285|Superiority||Odds Ratio (OR)|0.45||||0.0004|2-Sided|95.0|0.29|0.7|||Regression, Logistic||||
1617694|NCT02404350|2970285|Superiority||Odds Ratio (OR)|0.75||||0.225|2-Sided|95.0|0.47|1.19|||Regression, Logistic||||
1617753|NCT02402322|2970453|Non-Inferiority or Equivalence|In the preliminary analysis, we studied the possible group differences in demographic data and pretreatment measures with chi-square tests and analysis of variance (ANOVA).||||||0.05|||||||ANOVA|||The participants’ pre- and posttreatment scores were studied with repeated measures ANOVA. Within- and between-group effect sizes were calculated using the pooled standard deviation, Cohen’s d.|
1617695|NCT02404350|2970286|Superiority||Treatment contrast in LS mean (Change)|-0.86|Standard Error of the Mean|0.096|<|0.0001|2-Sided|95.0|-1.05|-0.67|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure|
1617696|NCT02404350|2970286|Superiority||Treatment Contrast in LS Mean (Change)|-0.66|Standard Error of the Mean|0.096|<|0.0001|2-Sided|95.0|-0.85|-0.47|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure|
1617697|NCT02404350|2970286|Superiority||Treatment contrast in LS mean (Change)|-0.66|Standard Error of the Mean|0.096|<|0.0001|2-Sided|95.0|-0.85|-0.47|||Mixed Models Analysis|LS Mean, 95% CI, and p-value are from a mixed model repeated measures (MMRM)||Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure|
1617698|NCT02404350|2970287|Superiority||Treatment Contrast inj LS mean (Change)|-0.33|Standard Error of the Mean|0.045|<|0.0001|2-Sided|95.0|-0.42|-0.24|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)|||
1617699|NCT02404350|2970287|Superiority||Treatment Contrast in LS mean (Change)|-0.23|Standard Error of the Mean|0.045|<|0.0001|2-Sided|95.0|-0.32|-0.14|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)|||
1617700|NCT02404350|2970287|Superiority|Mixed model with treatment regimen, analysis visit and randomization stratum (TNF-alpha status -naïve or IR) as factors, weight and baseline score as continuous covariates, and treatment by analysis visit and baseline score by analysis visit as interaction terms, using an unstructured covariance structure|Treatment contrast in LS mean (Change)|-0.24|Standard Error of the Mean|0.045|<|0.0001|2-Sided|95.0|-0.32|-0.15|||Mixed Models Analysis|LS Mean, 95% confidence interval, and p-value are from a mixed model for repeated measures (MMRM)|||
1617701|NCT02404350|2970288|Superiority||Odds Ratio (OR)|7.43|||<|0.0001|2-Sided|95.0|4.61|12.0|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.|
1617702|NCT02404350|2970288|Superiority||Odds Ratio (OR)|6.37|||<|0.0001|2-Sided|95.0|3.93|10.32|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.|
1617703|NCT02404350|2970288|Superiority||Odds Ratio, log|5.37|||<|0.0001|2-Sided|95.0|3.3|8.73|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.|
1617704|NCT02404350|2970289|Superiority||Odds Ratio (OR)|12.55|||<|0.0001|2-Sided|95.0|6.43|24.48|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."|
1617705|NCT02404350|2970289|Superiority||Odds Ratio (OR)|6.14|||<|0.0001|2-Sided|95.0|3.18|11.87|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."|
1617706|NCT02404350|2970289|Superiority||Odds Ratio (OR)|4.51|||<|0.0001|2-Sided|95.0|2.31|8.83|||Regression, Logistic|||"Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.~Missing responses are imputed as non-responders."|
1617707|NCT02404350|2970290|Superiority||Odds Ratio (OR)|18.06|||<|0.0001|2-Sided|95.0|9.56|34.12|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.|
1617708|NCT02404350|2970290|Superiority||Odds Ratio (OR)|11.66|||<|0.0001|2-Sided|95.0|6.37|21.37|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.|
1617709|NCT02404350|2970290|Superiority||Odds Ratio (OR)|10.15|||<|0.0001|2-Sided|95.0|5.52|18.63|||Regression, Logistic|||Odds ratio, 95% confidence interval, and p-value are from a logistic regression model with treatment and randomization stratum (TNF-alpha status -naïve or IR) as factors and baseline weight as a covariate.|
1617710|NCT02404350|2970291|Superiority||Difference in Mean|-0.48|Standard Error of the Mean|0.13||0.0003|||||||Non-parametric ANCOVA model||For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.|
1617711|NCT02404350|2970291|Superiority||Difference in Mean|-0.36|Standard Error of the Mean|0.13||0.0048|2-Sided||||||Non-parametric ANCOVA model||*For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.|
1617712|NCT02404350|2970291|Superiority||Difference in Mean|-0.61|Standard Error of the Mean|0.22||0.0061|2-Sided||||||Non-parametric ANCOVA model||*For the Statistical Test of the Hypothesis for the Secondary Outcome, The Estimation Parameter is the Standard Error of the Difference in Mean and not Standard Error of the Mean|Secukinumab 300 mg With Load compared to Placebo Estimate (for the difference in mean), SE and p-value are from a non-parametric ANCOVA model (Koch, 1998) with the change from baseline van der Heijde total modified Sharp score (or Erosion Score or Joint Space Narrowing Score) as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.|
1617713|NCT02404350|2970292|Superiority||Odds Ratio (OR)|4.58|||<|0.0001|2-Sided|95.0|3.16|6.63|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.|
1617714|NCT02404350|2970292|Superiority||Odds Ratio (OR)|3.38|||<|0.0001|2-Sided|95.0|2.35|4.87|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.|
1617715|NCT02404350|2970292|Superiority||Odds Ratio (OR)|4.02|||<|0.0001|2-Sided|95.0|2.78|5.79|||Regression, Logistic|||Statistical values were calculated from a logistic regression model with treatment and randomization stratum (TNF-a status -naive or Incidence Rate) as factors and baseline weight as a covariate.|
1617716|NCT02404285|2970304|Superiority||||||<|0.001|||||||ANOVA||||
1617717|NCT02404285|2970306|Superiority||||||<|0.01|||||||ANOVA||||
1617718|NCT02404103|2970314|Equivalence|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.6|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used|||
1617719|NCT02404103|2970314|Equivalence|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.543|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used|||
1617720|NCT02404103|2970314|Equivalence|To assess the impact of flunisolide on small airway parameters using spirometry and impulse oscillometry and determine whether there is a dose-related difference (320 mcg vs 160 mcg) with flunisolide HFA in pediatric patients who have evidence of small airway obstruction.||||||0.62|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.|||
1617721|NCT02404103|2970315|Equivalence|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.102|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.|||
1617722|NCT02404103|2970315|Equivalence|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.906|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.|||
1617723|NCT02404103|2970315|Equivalence|The primary aim is to compare the average change in spirometric values (FEV1 and FEF25-75%) and AX from baseline to Week 6 from participants randomized flunisolide HFA 1 inhalation BID and to flunisolide HFA 2 inhalations BID.||||||0.782|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used.|||
1617724|NCT02404103|2970316|Equivalence|A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.582|||||||Mixed Models Analysis||||
1617725|NCT02404103|2970316|Equivalence|secondary goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.82|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used|||
1617726|NCT02404103|2970316|Equivalence|The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction.||||||0.872|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used|||
1617727|NCT02404103|2970317|Equivalence|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used||||||0.921|||||||Mixed Models Analysis||||
1617728|NCT02404103|2970317|Equivalence|A goal was to evaluate whether flunisolide HFA 320 mcg when compared to flunisolide 160 mcg lead to significantly better improvement in the same outcome measures over time.||||||0.74|||||||Mixed Models Analysis||||
1617729|NCT02404103|2970317|Equivalence|The primary goal of the current study is to determine the effects of Aerospan on lung function in children with small airway obstruction with two doses.||||||0.148|||||||Mixed Models Analysis|generalized linear mixed-effects models (GLMM) using the identity link function and normal distribution were used|||
1617730|NCT02403830|2970360|Superiority||Mean Difference (Final Values)|-32.0||||0.261|2-Sided|95.0|-90.0|25.0|||Mixed Models Analysis||||
1617731|NCT02403817|2970361|Other|||||||0.018|||||||t-test, 2 sided|||This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary eye movement outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).|
1617754|NCT02402218|2970459|Superiority|||||||0.3||||||changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.|Chi-squared||||
1617856|NCT02397785|2970657|Superiority|||||||0.461|||||||Sign test||||
1617857|NCT02397785|2970658|Superiority|||||||0.4986|||||||Sign test||||
1617732|NCT02403817|2970362|Other|This is a small pilot study with no power calculations required (and no data upon which to base a priori power estimates).||||||5e-05|||||||t-test, 2 sided|||This analysis compares pre-intervention to post-intervention scores in the eye movement training group on the primary attention outcome measure. The hand movement Control in this pilot was not feasible and the sample is too small for analysis. This is a small pilot study and so power analyses were not computed. The null hypothesis was no difference between pre- and post-training outcome measure (alpha .05).|
1617733|NCT02403674|2970373|Superiority||Difference in mean %change from baseline|-6.47|||||2-Sided|95.0|-7.97|-4.96|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.||
1617734|NCT02403674|2970374|Superiority||Difference in mean %change from baseline|-35.96|||||2-Sided|95.0|-47.1|-24.82|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.||
1617735|NCT02403674|2970375|Superiority||Difference in mean %change from baseline|-23.44|||||2-Sided|95.0|-27.57|-19.32|||||95% CIs for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.||
1617736|NCT02403674|2970376|Superiority||Difference in mean %change from baseline|-17.02|||<|0.0001|2-Sided|95.0|-20.89|-13.16|||ANCOVA||95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.||
1617737|NCT02403674|2970377|Superiority||Difference in mean %change from baseline|-10.01|||<|0.0001|2-Sided|95.0|-13.53|-6.49|||ANCOVA||95% CIs and 2-sided p-values for treatment difference were calculated from an ANCOVA model with terms for baseline lipid level and treatment.||
1617738|NCT02403674|2970378|Superiority|Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.|Difference in percentages|-0.8|||<|0.001|2-Sided|95.0|-2.5|0.5||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Psychosis and psychotic disorders difference|
1617739|NCT02403674|2970378|Superiority|Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.|Difference in percentages|-2.5|||<|0.001|2-Sided|95.0|-5.9|0.8||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Depression and suicide/self-injury difference|
1617740|NCT02403674|2970379|Other|Difference in percentage of participants with ≥1 AE(s)|Difference in percentages|-3.6|||||2-Sided|95.0|-6.9|-0.5|||||95% CIs were calculated with the Miettinen & Nurminen method.||
1617741|NCT02403674|2970380|Other|Difference in percentage of participants with ≥1 AE(s)|Difference in percentages|-8.0|||||2-Sided|95.0|-13.0|-3.1|||||95% CIs were calculated with the Miettinen & Nurminen method.||
1617742|NCT02403674|2970382|Superiority|Superiority was declared when group difference (MK-1439A-ATRIPLA®) was a positive value.|Difference in mean %change from baseline|10.1|||||2-Sided|95.0|-16.1|36.3|||||95% CIs were calculated based on t-distribution.||
1617743|NCT02403674|2970384|Non-Inferiority|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.|Difference in percentages|4.1|||||2-Sided|95.0|-1.5|9.7|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or >100,000 copies/mL).||
1617744|NCT02403674|2970386|Superiority|Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.|Difference in percentages|-3.8||||0.033|2-Sided|95.0|-7.6|-0.3||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Altered sensorium difference|
1617745|NCT02403674|2970386|Superiority|Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.|Difference in percentages|-13.5|||<|0.001|2-Sided|95.0|-19.1|-7.9||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Sleep disorders and disturbances difference|
1617746|NCT02403674|2970386|Superiority|Superiority was declared when the 1-sided p-value comparing treatment difference was <0.02497.|Difference in percentages|-28.3|||<|0.001|2-Sided|95.0|-34.0|-22.5||2-sided P-value|t-test, 2 sided||95% CIs were calculated using the Miettinen and Nurminen method.|Dizziness difference|
1617747|NCT02403674|2970387|Non-Inferiority|Non-inferiority was declared if the lower bound of the 95% CI of the mean treatment difference was greater than -10.|Difference in percentages|3.537|||||2-Sided|95.0|-1.951|9.026|||||The 95% CIs for difference in percentages were calculated using stratum-adjusted Mantel-Haenszel method for each stratum (HIV-1 RNA ≤100,000 or >100,000 copies/mL).||
1617748|NCT02402881|2970434|Other||Odds Ratio (OR)|1.0|||<|0.05|2-Sided|95.0|||||Mixed Models Analysis|We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.||Our secondary outcome was the proportion of VTE events. We compared rates of VTE prophylaxis nonadministration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% CIs, the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.|
1617749|NCT02402881|2970435|Other||Odds Ratio (OR)|1.0|||<|0.05|2-Sided|95.0|||||Mixed Models Analysis|We used generalized linear mixed-effects models with multiple outputation reiterated 1000 times to bootstrap the 95% CIs and the P values.||Our primary outcome was the proportion of non-administered doses of prescribed pharmacologic VTE prophylaxis. We compared rates of VTE prophylaxis non-administration pre-post-intervention. For estimating conditional odds ratios (ORs) and their 95% confidence intervals (CIs), the binomial family and a logit link were used; for estimating the conditional proportions, the Poisson family and a log link were used.|
1617750|NCT02402452|2970442|Other||GLSM Ratio (%)|145.43|||||2-Sided|90.0|83.77|252.48||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of Cmax for the comparison groups using two 1-sided tests.|
1617751|NCT02402452|2970443|Other||GLSM Ratio (%)|171.27|||||2-Sided|90.0|97.65|300.38||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUCinf for the comparison groups using two 1-sided tests.|
1617752|NCT02402452|2970444|Other||Geometric Least-Square Mean(GLSM)Ratio %|172.92|||||2-Sided|90.0|97.93|305.33||||||An analysis of variance (ANOVA) appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio of AUClast for the comparison groups using two 1-sided tests.|
1617757|NCT02402218|2970463|Superiority|||||||0.11||||||For the primary and secondary outcomes, the proportion of participants with the outcome in each group was compared using a chi-square test.|Chi-squared|||Sample size was based on an estimated HCV treatment initiation rate of 50% in the UC group (based on a 33% rate observed during the interferon era) and 80% in the intervention groups, a significance level of 0.05, a desired ratio of participants in the intervention group compared to UC group of 3 to 2, and power of 80% to detect this difference between groups. The study was not powered to detect differences between the peer and cash groups.|
1617758|NCT02401867|2970480|Superiority or Other||Negative predictive value|94.74|||||2-Sided|95.0|88.9|98.04|||||Used exact confidence intervals|Assessed negative predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).|
1617759|NCT02401867|2970480|Superiority or Other||Positive Predictive Value|88.24|||||2-Sided|95.0|63.56|98.54|||||Used exact confidence intervals.|Assessed positive predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).|
1617760|NCT02401867|2970480|Non-Inferiority or Equivalence|Assessed specificity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).|Specificity|98.18|||||2-Sided|95.0|93.59|99.78|||||Used exact confidence intervals.||
1617761|NCT02401867|2970480|Superiority or Other||Sensitivity|71.43|||||2-Sided|95.0|47.82|88.72|||||Used exact confidence intervals.|Assessed sensitivity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).|
1617762|NCT02401867|2970480|Superiority or Other||Kappa|0.75|Standard Error of the Mean|0.08|<|0.001|2-Sided|95.0|0.58|0.92||A priori threshold: p<0.05|Kappa||Using the asymptotic standard error assuming the null hypothesis.|Concordance of HPV DNA detection between self-swab and provider swab assessed via an unweighted Kappa (K) statistic to determine the percentage agreement beyond that expected by chance.|
1617763|NCT02401867|2970480|Non-Inferiority or Equivalence|We selected our initial sample size of 150 participants to detect a clinically meaningful % discordance between the two sampling approaches and achieve 90% power at the 0.05 alpha-level using McNemar’s test adjusted for analysis of clustered matched-pair data.|||||<|0.29||||||Statistical significance was determined at an a priori threshold of p <0.05|McNemar|Degrees of freedom = 1||Comparing the concordance of the HPV DNA-positive results to the cervical provider swab HPV DNA test results (reference) using the McNemar’s test, a two-sample test for binomial proportions for matched-pair data. Null hypothesis: The sensitivities between swab 1 (self-vaginal) and swab 2 (provider-cervical) are equal [ H0 : p1 = p2 ]|
1617764|NCT02401529|2970483|Superiority or Other|||||||0.019|||||||Chi-squared||||
1617765|NCT02401529|2970484|Superiority or Other|||||||0.026|||||||Chi-squared||||
1617766|NCT02401529|2970485|Superiority or Other|||||||0.017|||||||Chi-squared||||
1617767|NCT02401529|2970486|Superiority or Other|||||||0.02|||||||Chi-squared||||
1617768|NCT02401529|2970487|Superiority or Other|||||||0.024|||||||Chi-squared||||
1617769|NCT02401529|2970488|Superiority or Other|||||||0.012|||||||Chi-squared||||
1617770|NCT02401529|2970489|Superiority or Other|||||||0.019|||||||Chi-squared||||
1617771|NCT02401529|2970490|Superiority or Other|||||||0.016|||||||Chi-squared||||
1617772|NCT02401529|2970491|Superiority or Other|||||||0.026|||||||Chi-squared||||
1617773|NCT02401529|2970492|Superiority or Other|||||||0.033|||||||Chi-squared||||
1617774|NCT02401464|2970498|Non-Inferiority or Equivalence|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)– ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)–ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.979|||||2-Sided|90.0|0.938|1.022||||||Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.|
1617775|NCT02401464|2970499|Non-Inferiority or Equivalence|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)– ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)–ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.985|||||2-Sided|90.0|0.958|1.011||||||Based on the ANOVA in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.|
1617776|NCT02401464|2970500|Non-Inferiority or Equivalence|Formulations were considered bioequivalent if: 1)90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)– ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)–ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|LS mean difference (ln)|0.906|||||2-Sided|90.0|0.88|0.933||||||Based on the ANOVA in which the natural logarithms of Cmax of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% CIs for the differences between the formulations and between the periods.|
1617801|NCT02400307|2970578|Equivalence|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|80.32|||||2-Sided|90.0|59.56|108.3||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.|
1617858|NCT02397785|2970659|Superiority|||||||0.2114|||||||Sign test||||
1617777|NCT02401464|2970501|Non-Inferiority or Equivalence|Formulations were considered bioequivalent if: 1) 90% Cls of the differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.80)– ln(1.25);2) Differences in the means of the natural log-transformed AUC(0-48) and Cmax between commercial and pediatric formulations was within ln(0.9)–ln(1.11),and results of the dissolution test met the conditions specified in the Guideline for Bioequivalence Studies of Generic Products.|Least Squares (LS) mean difference (ln)|0.963|||||2-Sided|90.0|0.927|1.001||||||Based on the analysis of variance (ANOVA) in which the natural logarithms of AUC(0-48) of TAK-536 were used as dependent variables, and formulation, sequence (administration order) and administration period were used as fixed effects, bioequivalence was assessed providing two-sided 90% confidence intervals (CIs) for the differences between the formulations and between the periods.|
1617778|NCT02400710|2970553|Superiority or Other|||||||0.05|||||||Chi-squared||||
1617779|NCT02400710|2970554|Superiority or Other|||||||0.05|||||||ANOVA||||
1617780|NCT02400580|2970555|Other|||||||0.508|||||||Fisher Exact||||
1617781|NCT02400580|2970557|Other|||||||0.517|||||||Fisher Exact||||
1617782|NCT02400333|2970572|Superiority or Other||Geometric mean ratio|96.5|||||2-Sided|95.0|93.26|99.87||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.|
1617783|NCT02400333|2970572|Superiority or Other||Geometric mean ratio|95.71|||||2-Sided|95.0|91.78|99.82||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.|
1617784|NCT02400333|2970572|Superiority or Other||Geometric mean ratio|94.82|||||2-Sided|95.0|91.36|98.42||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.|
1617785|NCT02400333|2970572|Superiority or Other||Geometric mean ratio|94.4|||||2-Sided|95.0|90.26|98.73||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.|
1617786|NCT02400333|2970572|Superiority or Other||Geometric mean ratio|95.24|||||2-Sided|95.0|89.81|100.99||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.|
1617787|NCT02400333|2970572|Superiority or Other||Geometric mean ratio|94.96|||||2-Sided|95.0|90.27|99.89||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.|
1617788|NCT02400333|2970573|Superiority or Other||Geometric mean ratio|96.56|||||2-Sided|95.0|93.08|100.17||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.|
1617789|NCT02400333|2970573|Superiority or Other||Geometric mean ratio|96.0|||||2-Sided|95.0|91.87|100.33||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.|
1617790|NCT02400333|2970573|Superiority or Other||Geometric mean ratio|94.67|||||2-Sided|95.0|90.94|98.56||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.|
1617791|NCT02400333|2970573|Superiority or Other||Geometric mean ratio|94.66|||||2-Sided|95.0|90.53|98.98||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.|
1617792|NCT02400333|2970573|Superiority or Other||Geometric mean ratio|95.41|||||2-Sided|95.0|89.94|101.21||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.|
1617793|NCT02400333|2970573|Superiority or Other||Geometric mean ratio|95.04|||||2-Sided|95.0|90.33|99.99||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.|
1617794|NCT02400333|2970574|Superiority or Other||Geometric mean ratio|97.07|||||2-Sided|95.0|90.83|103.74||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.|
1617795|NCT02400333|2970574|Superiority or Other||Geometric mean ratio|97.45|||||2-Sided|95.0|90.53|104.9||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.|
1617796|NCT02400333|2970574|Superiority or Other||Geometric mean ratio|89.84|||||2-Sided|95.0|82.03|98.39||||||Statistical assessment of metabolite AR-C124910XX relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.|
1617797|NCT02400333|2970574|Superiority or Other||Geometric mean ratio|92.16|||||2-Sided|95.0|85.59|99.25||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets suspended in water and administered through NG tube compared to ticagrelor IR tablets.|
1617798|NCT02400333|2970574|Superiority or Other||Geometric mean ratio|96.61|||||2-Sided|95.0|88.22|105.79||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered without water compared to ticagrelor IR tablets.|
1617799|NCT02400333|2970574|Superiority or Other||Geometric mean ratio|84.85|||||2-Sided|90.0|76.77|93.78||||||Statistical assessment of ticagrelor relative bioavailability following ticagrelor OD tablets administered with water compared to ticagrelor IR tablets.|
1617800|NCT02400307|2970577|Equivalence|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|109.8|||||2-Sided|90.0|87.46|137.85||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.|
1617844|NCT02397837|2970645|Other||||||||||||||||||Tabulation of participants with suicidal acknowledgements over 12-week study
1617845|NCT02397837|2970646|Other|||||||0.98|||||||t-test, 2 sided||||
1617802|NCT02400307|2970579|Equivalence|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|99.02|||||2-Sided|90.0|79.24|123.74||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.|
1617803|NCT02400307|2970580|Equivalence|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|72.43|||||2-Sided|90.0|48.54|108.07||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.|
1617804|NCT02400307|2970581|Equivalence|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|GLSM Ratio|99.29|||||2-Sided|90.0|79.49|124.04||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.|
1617805|NCT02400307|2970582|Equivalence|For the power and sample size analysis, it was assumed that a one-sided t-test was performed at an alpha level of 0.05 and the inter-subject standard deviations for the three natural log scale PK parameters are 0.466 or smaller (based on another Gilead study) and the expected difference was 0.|Geometric Least-Square Mean (GLSM) Ratio|72.63|||||2-Sided|90.0|48.8|108.1||||||A sample size of 8 evaluable participants in each group will provide at least 88% power to reject the null hypothesis that participants with severe impairment have at least 100% increase in bictegravir AUCinf, AUClast, or Cmax compared to participants with normal renal function.|
1617806|NCT02399163|2970601|Superiority or Other||Mean Difference (Net)|16.76|||<|0.0001|2-Sided|95.0|11.061|22.454||From ANOVA: participant (random), treatment (fixed), period (fixed)|ANCOVA||Difference is Placebo dentifrice/Fluoride rinse minus Placebo dentifrice/No rinse such that a positive difference implies a larger response value for the Placebo dentifrice/Fluoride rinse.||
1617807|NCT02398227|2970609|Superiority|||||||0.56|||||||ANCOVA|p value reported for overall effect across all-time points between treatment arms|||
1617808|NCT02398227|2970610|Superiority|||||||0.968|||||||ANCOVA|p value reported for overall effect across all-time points between treatment arms|||
1617809|NCT02398188|2970612|Superiority|||||||0.379|||||||Cochran-Mantel-Haenszel||||
1617810|NCT02398188|2970613|Superiority|||||||0.397|||||||Cochran-Mantel-Haenszel||||
1617811|NCT02397915|2970619|Superiority or Other||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617812|NCT02397915|2970620|Superiority or Other||Median Difference (Final Values)|0.0||||0.568||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617813|NCT02397915|2970621|Superiority or Other||Median Difference (Final Values)|0.0||||0.007||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617814|NCT02397915|2970622|Superiority or Other||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617815|NCT02397915|2970623|Superiority or Other||Median Difference (Final Values)|0.0||||0.831||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617816|NCT02397915|2970624|Superiority or Other||Median Difference (Final Values)|0.0||||0.008||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617817|NCT02397915|2970625|Superiority or Other||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617818|NCT02397915|2970626|Superiority or Other||Median Difference (Final Values)|0.0||||0.223||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617819|NCT02397915|2970627|Superiority or Other||Median Difference (Final Values)|0.0||||0.004||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617820|NCT02397915|2970628|Superiority or Other||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617846|NCT02397837|2970647|Other|||||||0.99|||||||t-test, 2 sided||||
1617847|NCT02397837|2970648|Other|||||||0.55|||||||t-test, 2 sided||||
1617848|NCT02397837|2970649|Other|||||||0.17|||||||t-test, 2 sided||||
1617821|NCT02397915|2970629|Superiority or Other||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617822|NCT02397915|2970630|Superiority or Other||Median Difference (Final Values)|0.0||||0.951||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all delayed attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617823|NCT02397915|2970631|Superiority or Other||Median Difference (Final Values)|0.0||||0.188||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617824|NCT02397915|2970632|Superiority or Other||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617825|NCT02397915|2970633|Superiority or Other||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617826|NCT02397915|2970634|Superiority or Other||Median Difference (Final Values)|0.0|||<|0.001||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617827|NCT02397915|2970635|Superiority or Other||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617828|NCT02397915|2970636|Superiority or Other||Median Difference (Final Values)|0.0||||0.179||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617829|NCT02397915|2970637|Superiority or Other||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617830|NCT02397915|2970638|Superiority or Other||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617831|NCT02397915|2970639|Superiority or Other||Median Difference (Final Values)|0.0||||1||||||Analyzed using an ANOVA mixed model with par. as random effect, ctry, tmt, BL rhinitis sym subgrp, and tmt seq as main effects. P-values for all immediate attribute rating scores adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617832|NCT02397915|2970640|Superiority or Other|||||||0.532||||||Par. preferences were analyzed using Prescott’s test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg’s method. P-value is for product attribute UTS.|Cochran-Mantel-Haenszel||||
1617833|NCT02397915|2970640|Superiority or Other||||||<|0.001||||||Par. preferences were analyzed using Prescott’s test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg’s method. P-value is for product attribute less irritating.|Cochran-Mantel-Haenszel||||
1617834|NCT02397915|2970640|Superiority or Other||||||<|0.046||||||Par. preferences were analyzed using Prescott’s test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg’s method. P-value is for product attribute more soothing.|Cochran-Mantel-Haenszel||||
1617835|NCT02397915|2970640|Superiority or Other||||||<|0.017||||||Par. preferences were analyzed using Prescott’s test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg’s method. P-value is for product attribute LRON.|Cochran-Mantel-Haenszel||||
1617836|NCT02397915|2970640|Superiority or Other||||||<|0.001||||||Par. preferences were analyzed using Prescott’s test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg’s method. P-value is for product attribute LDTT.|Cochran-Mantel-Haenszel||||
1617837|NCT02397915|2970640|Superiority or Other||||||<|0.138||||||Par. preferences were analyzed using Prescott’s test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg’s method. P-value is for product attribute after taste.|Cochran-Mantel-Haenszel||||
1617838|NCT02397915|2970640|Superiority or Other||||||<|0.532||||||Par. preferences were analyzed using Prescott’s test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg’s method. P-value is for product attribute immediate taste.|Cochran-Mantel-Haenszel||||
1617839|NCT02397915|2970640|Superiority or Other||||||<|0.065||||||Par. preferences were analyzed using Prescott’s test, as approximated by a CMH test, adjusted for ctry and sym. All preference p-values were also adjusted for multiplicity using Hochberg’s method. P-value is for product attribute scent/odor.|Cochran-Mantel-Haenszel||||
1617840|NCT02397915|2970641|Superiority or Other||||||<|0.001||||||Par. preferences were analyzed using Prescott’s test, as approximated by a Cochran-Mantel-Haenszel test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg’s method.|Cochran-Mantel-Haenszel||||
1617841|NCT02397837|2970642|Other|||||||0.17|||||||t-test, 2 sided||||
1617842|NCT02397837|2970643|Other|||||||1|||||||t-test, 2 sided||||
1617843|NCT02397837|2970644|Other|||||||0.09|||||||t-test, 2 sided||||
1617849|NCT02397837|2970650|Other|||||||0.22|||||||t-test, 2 sided||||
1617859|NCT02397785|2970660|Superiority|||||||0.7827|||||||Sign test||||
1617860|NCT02397785|2970661|Superiority|||||||0.0574|||||||Sign test||||
1617861|NCT02397785|2970662|Superiority|||||||0.9954|||||||Sign test||||
1617862|NCT02397785|2970663|Superiority|||||||0.2887|||||||Sign test||||
1617863|NCT02397785|2970664|Superiority|||||||0.0287|||||||Sign test||||
1617864|NCT02397785|2970665|Superiority|||||||0.0855|||||||Sign test||||
1617865|NCT02397785|2970666|Superiority|||||||0.2884|||||||Sign test||||
1617866|NCT02397785|2970667|Superiority|||||||0.286|||||||Sign test||||
1617867|NCT02397785|2970668|Superiority|||||||0.3817|||||||Sign test||||
1617868|NCT02397785|2970669|Superiority|||||||0.1568|||||||Sign test||||
1617869|NCT02397785|2970670|Superiority|||||||0.9338|||||||Sign test||||
1617870|NCT02397785|2970671|Superiority|||||||0.8979|||||||t-test, 2 sided|||It was calculated that 52 participants (26 in each arm) was sufficient to detect a 30% reduction in the VAS score (⍺ = 0.05, β = 0.80) from baseline to 12 weeks using paired t-tests, assuming average pain of 80-90 on the VAS and 10% drop-out. Because stratified randomization was performed on the basis of levator ani muscle spasm, there was an imbalance between the size of the sham and active groups, and 58 subjects were ultimately recruited with approval from the Institutional Review Board.|
1617871|NCT02397707|2970672|Other||GLSM Ratio (%)|713.92|||||2-Sided|90.0|384.07|1327.06||||||An ANOVA appropriate was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.|
1617872|NCT02397707|2970672|Other||GLSM Ratio (%)|338.41|||||2-Sided|90.0|168.96|677.79||||||An ANOVA appropriate was fitted to the natural logarithmic transformation of voxilaprevir Cmax. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.|
1617873|NCT02397707|2970673|Other||GLSM Ratio (%)|599.63|||||2-Sided|90.0|342.36|1050.22||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUCinf for the comparison groups using two 1-sided tests.|
1617874|NCT02397707|2970673|Other||GLSM Ratio (%)|399.24|||||2-Sided|90.0|210.89|755.81||||||An ANOVA appropriate for parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUCinf. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.|
1617875|NCT02397707|2970674|Other||GLSM Ratio (%)|644.15|||||2-Sided|90.0|364.67|1137.82||||||An ANOVA appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% CI was constructed for the GLSM ratio of AUClast for the comparison groups using two 1-sided tests.|
1617876|NCT02397707|2970674|Other||Geometric Least-Square Mean (GLSM)Ratio%|411.62|||||2-Sided|90.0|214.72|789.08||||||An analysis of variance (ANOVA) appropriate for a parallel design was fitted to the natural logarithmic transformation of voxilaprevir AUClast. A 90% confidence interval (CI) was constructed for the geometric least squares mean (GLSM) ratio of AUClast for the comparison groups using two 1-sided tests.|
1617877|NCT02397694|2970690|Non-Inferiority|Noninferiority of treatment with BIC + F/TAF relative to treatment with DTG + F/TAF. Noninferiority assessed using a conventional 95% confidence interval (CI) approach, with a noninferiority margin of 12%|Difference in percentages|2.9||||0.5|2-Sided|95.0|-8.5|14.2|||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline HIV-1 RNA stratum (≤ 100,000 copies/mL vs > 100,000 copies/mL).|||
1617878|NCT02397564|2970693|Superiority or Other|||||||0.019|||||||Wilcoxon (Mann-Whitney)||||
1617879|NCT02397473|2970699|Superiority||Odds Ratio (OR)|0.929||||0.841|2-Sided|95.0|0.449|1.923|||Mixed Models Analysis|Pseudolikelihood-based repeated measures model|||
1617880|NCT02397473|2970700|Superiority||Odds Ratio (OR)|0.965||||0.91|2-Sided|95.0|0.512|1.819|||Mixed Models Analysis|Pseudo-likelihood-based repeated measures.|||
1617881|NCT02397473|2970701|Superiority||Odds Ratio (OR)|1.312||||0.575|2-Sided|95.0|0.502|3.426|||Mixed Models Analysis||||
1617882|NCT02397473|2970702|Superiority||Odds Ratio (OR)|3.046||||0.016|2-Sided|95.0|1.242|7.469|||Mixed Models Analysis||||
1617883|NCT02397473|2970703|Superiority||LSMean Difference|-0.83|Standard Error of the Mean|1.2||0.493|2-Sided|95.0|-3.23|1.57|||Mixed Models Analysis||||
1617884|NCT02397473|2970704|Superiority|||||||0.046|||||||ANCOVA|Koch's nonparametric randomization-based ANCOVA.|||
1617885|NCT02397473|2970705|Superiority||LSMean Difference|-3.47|Standard Error of the Mean|1.63||0.036|2-Sided|95.0|-6.72|-0.23|||Mixed Models Analysis||||
1617886|NCT02397122|2970707|Superiority|||||||0.001||||||<0.05|Mann-Whitney U|||6 months|
1617887|NCT02397122|2970707|Superiority|||||||0.001|||||||Mann-Whitney|||6 weeks|
1617888|NCT02397122|2970707|Superiority|||||||0.946|||||||Mann-Whitney|||Baseline|
1617889|NCT02397122|2970708|Superiority|||||||0.077|||||||Mann-Whitney U||||
1617890|NCT02397122|2970708|Superiority|||||||0.099|||||||Mann-Whitney|||6 weeks|
1617891|NCT02397122|2970708|Superiority|||||||0.245|||||||Mann-Whitney|||Baseline|
1617892|NCT02397122|2970709|Superiority|||||||0.064||||||<0.05|Mann-Whitney U|||6 months|
1617893|NCT02397122|2970709|Superiority|||||||0.041|||||||Mann-Whitney|||6 weeks|
1617894|NCT02397122|2970709|Superiority|||||||0.136|||||||Mann-Whitney|||Baseline|
1617895|NCT02397122|2970710|Superiority|||||||0.317||||||<0.05|Mann-Whitney U|||6 months|
1617896|NCT02397122|2970710|Superiority|||||||0.152|||||||Mann-Whitney|||6 weeks|
1617897|NCT02397122|2970710|Superiority|||||||0.298|||||||Mann-Whitney|||Baseline|
1617898|NCT02397122|2970711|Superiority|||||||0.128||||||<0.05|Mann-Whitney U|||6 months|
1617899|NCT02397122|2970711|Superiority|||||||0.13|||||||Mann-Whitney|||6 weeks|
1617900|NCT02397122|2970711|Superiority|||||||0.067|||||||Mann-Whitney|||Baseline|
1617901|NCT02397122|2970712|Superiority|||||||0.07||||||<0.05|Mann-Whitney U|||6 months|
1617902|NCT02397122|2970712|Superiority|||||||0.097|||||||Mann-Whitney|||6 weeks|
1617903|NCT02397122|2970712|Superiority|||||||0.259|||||||Mann-Whitney|||Baseline|
1618016|NCT02391987|2971117|Superiority|||||||0.37|||||||Fisher Exact||||
1617904|NCT02397096|2970716|Non-Inferiority|DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -4 percentage points.|Treatment Difference|-0.232|||||2-Sided|95.0|-2.529|2.064|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||
1617905|NCT02397096|2970717|Other||Treatment Difference|-0.427|||||2-Sided|95.0|-4.591|3.738|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||
1617906|NCT02397096|2970718|Other||Treatment Difference|-3.556|||||2-Sided|95.0|-7.977|0.864|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||
1617907|NCT02397096|2970719|Superiority||Mean Difference (Final Values)|-12.8|||||2-Sided|95.0|-41.1|15.4|||||95% Confidence Intervals were based on t-distribution.||
1617908|NCT02397096|2970720|Other||Mean Difference (Final Values)|-4.0|||||2-Sided|95.0|-31.6|23.5|||||95% CIs were calculated based on t-distribution.||
1617909|NCT02397096|2970721|Non-Inferiority|DOR/3TC/TDF QD ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.|Treatment Difference|-0.877|||||2-Sided|95.0|-4.706|2.952|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).
1617910|NCT02397096|2970722|Other||Treatment Difference|-23.03|||<|0.0001|2-Sided|95.0|-28.0|-18.05|||ANCOVA||95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.||
1617911|NCT02397096|2970723|Other||Treatment Difference|-14.65|||<|0.0001|2-Sided|95.0|-18.92|-10.38|||ANCOVA||95% CIs and 2-sided p-values were calculated from an ANCOVA model with terms for baseline lipid level, use of lipid-lowering therapy at Study Day 1 and treatment.||
1617912|NCT02397096|2970724|Non-Inferiority|Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) once daily (QD) ISG is concluded to be non-inferior to baseline regimen DSG if the lower bound of the 95% CI for the difference in percent response is above -8 percentage points.|Treatment Difference|-3.784|||||2-Sided|95.0|-7.877|0.31|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||Superiority of an immediate switch to DOR/3TC/TDF over continuation of the baseline regimen was defined by a lower bound of the two-sided 95% CI for the difference in response rates being greater than zero (contingent upon satisfying the multiplicity criteria).
1617913|NCT02396420|2970754|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617914|NCT02396420|2970755|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617915|NCT02396420|2970756|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617916|NCT02396420|2970757|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617917|NCT02396420|2970758|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617918|NCT02396420|2970759|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617919|NCT02396420|2970760|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617920|NCT02396420|2970761|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617921|NCT02396420|2970762|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617922|NCT02396420|2970763|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617923|NCT02396420|2970764|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617924|NCT02396420|2970765|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617925|NCT02396420|2970766|Other|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.||||||||||||||||Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.
1617926|NCT02396420|2970767|Other|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.||||||||||||||||Statistical analysis was not performed as this data was not available for any subjects in the analysis population.|Statistical analysis was not performed as this data was not available for any subjects in the analysis population.
1617927|NCT02396420|2970768|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617928|NCT02396420|2970769|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1617929|NCT02396420|2970770|Other||||||||||||||||||Statistical analysis was not performed as the sample size is insufficient to have confidence that the results would be meaningful for the overall target population.
1618017|NCT02391987|2971118|Superiority|||||||0.98|||||||Cochran-Mantel-Haenszel||||
1617930|NCT02396381|2970771|Superiority||% Reduction|32.2|||<|0.001|2-Sided|96.875|24.5|39.0|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 – LS Mean Ratio (THS / CC)|"The analysis will test if the mean level of COHb for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC < 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use. H0 is rejected with a type I error α = 1.5625% (one-sided test)."|
1617931|NCT02396381|2970772|Superiority||% Reduction|43.5|||<|0.001|2-Sided|96.875|33.7|51.9|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 – LS Mean Ratio (THS / CC)|"The analysis of Total NNAL will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC < 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."|
1617932|NCT02396381|2970773|Superiority||% Reduction|6.8||||0.018|2-Sided|96.875|-0.216|13.3|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 – LS Mean Ratio (THS / CC)|"The analysis of 8-epi-PGF2α will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC < 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."|
1617933|NCT02396381|2970774|Superiority||% Reduction|4.74||||0.193|2-Sided|96.875|-7.5|15.6|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 – LS Mean Ratio (THS / CC)|"The analysis of 11-DTX-B2 will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC < 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."|
1617934|NCT02396381|2970775|Superiority||% Reduction|2.86||||0.03|2-Sided|96.875|-0.426|6.04|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach|Derived as 1 – LS Mean Ratio (THS / CC)|"The analysis of sICAM-1 will test if the mean level of this clinical risk endpoint for THS-use is lower relative to CC-use. The following hypothesis will be evaluated:~H0: XTHS / XCC ≥ 1.0~HA: XTHS / XCC < 1.0~where XTHS and XCC are the adjusted geometrical means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."|
1617935|NCT02396381|2970776|Superiority||LS Mean Difference|1.28||||0.008|2-Sided|96.875|0.145|2.42|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of FEV1 for THS-use is greater than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≤ 0.0~HA: XTHS - XCC > 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."|
1617936|NCT02396381|2970777|Superiority||LS Mean Difference|-0.42||||0.001|2-Sided|96.875|-0.717|-0.123|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of WBC for THS-use is lower than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≥ 0.0~HA: XTHS - XCC < 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."|
1617937|NCT02396381|2970778|Other||LS Mean Difference|3.09|||<|0.001|2-Sided|96.875|1.1|5.09|||Hailperin-Rüger|p-value less than 1.5625% would be considered statistically significant, following test multiplicity adjustment using the Hailperin-Rüger approach||"The analysis will test if the mean level of HDL-C for THS-use is greater than for CC-use. The following hypothesis will be evaluated:~H0: XTHS - XCC ≤ 0.0~HA: XTHS - XCC > 0.0~where XTHS and XCC are the adjusted means of THS-use and CC-use, respectively. H0 is rejected with a type I error α = 1.5625% (one-sided test)."|
1617938|NCT02396316|2970779|Superiority or Other||MH adjusted difference|59.1|||||2-Sided|95.0|37.0|81.2||||||The point estimate of the treatment difference (the aflibercept group minus the sham group) at Week 1 and its two-sided 95% confidence interval stratified by stage of NVG (as randomized) using Mantel-Haenszel weights.|
1617939|NCT02396316|2970780|Superiority or Other||Difference of LS mean change|-4.9||||0.0644|2-Sided|95.0|-10.2|0.3|||ANCOVA|||Point estimate, 95% CI and P-value were based on treatment difference of the LS mean changes using an ANCOVA model with treatment group and stage of NVG for randomization as fixed effects, baseline value as covariate. The superiority of aflibercept injection to sham injection was to be established if the upper limit of the two-sided 95% confidence interval for the difference (the aflibercept group minus the sham group) is less than 0.|
1617940|NCT02396147|2970811|Superiority or Other||Geometric Mean Ratio|92.99|||||2-Sided|90.0|76.84|112.54|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) * 100||
1617941|NCT02396147|2970811|Superiority or Other||Geometric Mean Ratio|81.16|||||2-Sided|90.0|64.36|102.34|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) * 100||
1617942|NCT02396147|2970811|Superiority or Other||Geometric Mean Ratio|78.09|||||2-Sided|90.0|64.53|94.51|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) * 100||
1617943|NCT02396147|2970811|Superiority or Other||Geometric Mean Ratio|94.43|||||2-Sided|90.0|74.85|119.12|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (reference) * 100||
1617944|NCT02396147|2970812|Superiority or Other||Geometric Mean Ratio|92.78|||||2-Sided|90.0|76.48|112.55|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) * 100||
1617945|NCT02396147|2970812|Superiority or Other||Geometric Mean Ratio|81.08|||||2-Sided|90.0|64.21|102.37|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) * 100||
1617946|NCT02396147|2970812|Superiority or Other||Geometric Mean Ration|77.99|||||2-Sided|90.0|64.29|94.61|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) * 100||
1617947|NCT02396147|2970812|Superiority or Other||Geometric Mean Ratio|94.53|||||2-Sided|90.0|74.83|119.4|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (Reference) *100||
1617948|NCT02396147|2970813|Superiority or Other||Geometric Mean Ratio|94.23|||||2-Sided|90.0|67.98|130.61|||||T4 Formulation C Fed (test)/T4 Formulation C Fasted (reference) * 100||
1617949|NCT02396147|2970813|Superiority or Other||Geometric Mean Ratio|78.59|||||2-Sided|90.0|52.88|116.79|||||T4 Formulation B Fed (test)/T4 Formulation B Fasted (reference) * 100||
1617950|NCT02396147|2970813|Superiority or Other||Geometric Mean Ratio|83.09|||||2-Sided|90.0|59.95|115.18|||||T4 Formulation C Fasted (test)/T2 Formulation Fasted (reference) * 100||
1617951|NCT02396147|2970813|Superiority or Other||Geometric Mean Ratio|87.09|||||2-Sided|90.0|58.56|129.52|||||T4 Formulation B Fasted (test)/T2 Formulation Fasted (reference)*100||
1617952|NCT02395536|2970837|Non-Inferiority|A non-inferiority margin of 5% was chosen since the inability to rule out a 5% increase in untoward event rate associated with moving the Reveal LINQ procedure in-office may suggest that in-office procedures would too high of a complication rate compared procedures performed in the traditional office setting.|Risk Difference (RD)|-0.001|||<|0.001|2-Sided|95.0|-0.03|0.029||P-value for non-inferiority versus a 5% non-inferiority margin.|Farrington-Manning test||The estimated value and its associated confidence interval are for the in-office minus traditional hospital setting difference in the untoward event rates. The point estimate is negative since the in-office rate was lower than the hospital rate.|The null hypothesis was that Reveal LINQ insertions performed in-office would have a higher untoward event rate than insertions performed in the traditional hospital setting. A sample size of 476 subjects was estimated to provide at least 90% power at a 1-sided alpha level of 2.5% and 5% non-inferiority margin. For the sample size calculation, an event rate of 2.0% was assumed in both arms. The Farrington-Manning test of two indepent proportions was used to compare study arms.|
1617953|NCT02395172|2970857|Superiority||Odds Ratio (OR)|1.76||||0.0105|2-Sided|95.0|1.08|2.86|||Cochran-Mantel-Haenszel|Test the null hypothesis that there is no association between treatment effect and Objective Response Rate in at least one randomization stratum.|||
1617954|NCT02395172|2970858|Superiority||Odds Ratio (OR)|1.4||||0.0554|2-Sided|95.0|0.92|2.13|||Cochran-Mantel-Haenszel|Test the null hypothesis that there is no association between treatment effect and Objective Response Rate in at least one randomization stratum.|||
1617955|NCT02395172|2970861|Superiority||Hazard Ratio (HR)|1.17||||0.9561|2-Sided|95.0|0.98|1.41|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank test.|||
1617956|NCT02395172|2970862|Superiority||Hazard Ratio (HR)|1.01||||0.5336|2-Sided|95.0|0.8|1.27|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank test.|||
1617957|NCT02395172|2970863|Superiority||Hazard Ratio (HR)|0.9||||0.1175|2-Sided|95.0|0.76|1.07|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank test.|||
1617958|NCT02395172|2970864|Superiority||Hazard Ratio (HR)|0.9||||0.1627|2-Sided|95.0|0.73|1.11|||Log Rank|The treatment arms were compared using a stratified, 1-sided, log rank test.|||
1617959|NCT02395133|2970880|Superiority||Percentage difference|-36.1|||<|0.0001|2-Sided|95.0|-48.4|-23.74||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.|
1617960|NCT02395133|2970880|Superiority||Percentage difference|-20.6|||=|0|2-Sided|95.0|-35.32|-5.89||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.|
1617961|NCT02395133|2970880|Superiority||Percentage difference|-14.4|||=|0.1048|2-Sided|95.0|-29.21|0.32||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.|
1617962|NCT02395133|2970881|Superiority||Percentage difference|39.7|||<|0.0001|2-Sided|95.0|27.42|51.95||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.|
1617963|NCT02395133|2970881|Superiority||Percentage difference|29.7|||=|0|2-Sided|95.0|14.89|44.42||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.|
1617964|NCT02395133|2970881|Superiority||Percentage difference|18.5|||=|0|2-Sided|95.0|4.14|32.91||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.|
1617965|NCT02395133|2970882|Superiority||Percentage difference|42.1|||<|0.0001|2-Sided|95.0|28.36|55.76||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.|
1617966|NCT02395133|2970882|Superiority||Percentage difference|33.5|||=|0|2-Sided|95.0|17.38|49.72||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.|
1617987|NCT02393417|2970973|Superiority||Odds Ratio (OR)|1.0||||0.8267|2-Sided|95.0|0.995|1.004|||Regression, Logistic||An odds ratio < 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.|
1617967|NCT02395133|2970882|Superiority||Percentage difference|21.4|||=|0|2-Sided|95.0|4.86|38.0||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.|
1617968|NCT02395133|2970883|Superiority||Percentage difference|41.2|||<|0.0001|2-Sided|95.0|28.93|53.52||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.|
1617969|NCT02395133|2970883|Superiority||Percentage difference|28.0|||=|0|2-Sided|95.0|13.32|42.58||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.|
1617970|NCT02395133|2970883|Superiority||Percentage difference|24.5|||=|0|2-Sided|95.0|9.7|39.29||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region, baseline disease severity and Dupilumab regimen received in parent studies.|
1617971|NCT02395133|2970884|Superiority||Percent Change Difference|-21.61|||<|0.0001|2-Sided|95.0|-28.36|-14.87|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.|
1617972|NCT02395133|2970884|Superiority||Percent Change Difference|-17.83|||<|0.0001|2-Sided|95.0|-25.33|-10.34|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.|
1617973|NCT02395133|2970884|Superiority||Percent Change Difference|-14.83|||=|0|2-Sided|95.0|-22.34|-7.33|||ANCOVA|Threshold for significance at 0.05 level.||A 2-sided hierarchical testing procedure was used for the co-primary and key secondary efficacy endpoints in a pre-specified order. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analysis was performed using ANCOVA method.|
1617974|NCT02395042|2970889|Superiority||Least Squares Mean Difference|-1.02||||0.137|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.|||
1617975|NCT02395042|2970889|Superiority||Least Squares Mean Difference|-1.46||||0.024|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.|||
1617976|NCT02395042|2970890|Superiority||Least Squares Mean Difference|-0.92||||0.319|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.|||
1617977|NCT02395042|2970890|Superiority||Least Squares Mean Difference|-1.15||||0.142|||||||ANCOVA|ANCOVA model with baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors.|||
1617978|NCT02394561|2970930|Superiority||||||<|0.0001||||||All time points|Wilcoxon (Mann-Whitney)||||
1617979|NCT02394561|2970931|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|At all time points|||
1617980|NCT02394561|2970932|Other|||||||0.447||||||difference between cohorts for PASI 75 using Kaplan-Meier estimate|Log Rank||||
1617981|NCT02394561|2970932|Other|difference between cohorts for PASI 90 using Kaplan-Meier estimate||||||0.1295|||||||Log Rank||||
1617982|NCT02394561|2970935|Non-Inferiority|The difference in percentage of patients achieving PASI 90 response between the Cw6-positive cohort and the Cw6-negative cohort was H0 = Cw6-positive minus Cw6-negative ≥0.12 and HA = Cw6-positive minus Cw6-negative was < 0.12. The percentage of PASI 90 response by cohort as well as the difference between cohort together with 97.5% upper CI was provided using Clopper Pearson CI method.|difference|-1.3|||||2-Sided|95.0|-8.8|6.2|||||||
1617983|NCT02393417|2970972|Superiority||Odds Ratio (OR)|1.001||||0.5572|2-Sided|95.0|0.997|1.006|||Regression, Logistic||An odds ratio > 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.|
1617984|NCT02393417|2970972|Superiority||Odds Ratio (OR)|0.998||||0.4183|2-Sided|95.0|0.993|1.003|||Regression, Logistic||An odds ratio > 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.|
1617985|NCT02393417|2970972|Superiority||Odds Ratio (OR)|1.0||||0.8168|2-Sided|95.0|0.997|1.003|||Regression, Logistic||An odds ratio > 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.|
1617986|NCT02393417|2970972|Superiority||Odds Ratio (OR)|0.964||||0.1657|2-Sided|95.0|0.915|1.015|||Regression, Logistic||An odds ratio > 1 indicates that the age of the largest primary injected wart is positively correlated with the recurrence of any resolved wart and vice versa.|Using a logistic regression model for recurrence status of any resolved wart (yes vs no) with age of the largest primary injected wart as a covariate.|
1618015|NCT02392234|2971097|Superiority||Least Squares (LS) Mean Difference|4.7|||<|0.0001|2-Sided|95.0|3.7|5.8|||Linear Mixed Effects Model||||
1617988|NCT02393417|2970973|Superiority||Odds Ratio (OR)|0.993||||0.0219|2-Sided|95.0|0.987|0.999|||Regression, Logistic||An odds ratio < 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.|
1617989|NCT02393417|2970973|Superiority||Odds Ratio (OR)|1.001||||0.5007|2-Sided|95.0|0.998|1.004|||Regression, Logistic||An odds ratio < 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.|
1617990|NCT02393417|2970973|Superiority||Odds Ratio (OR)|0.999||||0.4824|2-Sided|95.0|0.997|1.001|||Regression, Logistic||An odds ratio < 1 indicates that the age of the wart is negatively correlated with positive treatment outcome and vice versa.|Using a logistic regression model for complete resolution status of largest primary injected wart (yes vs no) with wart age as a covariate.|
1617991|NCT02393417|2970979|Superiority||Cox Proportional Hazard|3.3257||||0.0003|2-Sided|95.0|1.7263|6.407|||Regression, Cox||||
1617992|NCT02393417|2970979|Superiority||Cox Proportional Hazard|3.1516||||0.0008|2-Sided|95.0|1.6148|6.1509|||Regression, Cox||||
1617993|NCT02393417|2970979|Superiority||Cox Proportional Hazard|2.7553||||0.0027|2-Sided|95.0|1.4211|5.3419|||Regression, Cox||||
1617994|NCT02393417|2970981|Superiority||Risk Ratio (RR)|3.0||||0.0451|2-Sided|95.0|0.9281|9.6975|||Cochran-Mantel-Haenszel||||
1617995|NCT02393417|2970981|Superiority||Risk Ratio (RR)|2.8908||||0.0014|2-Sided|95.0|1.4169|5.8978|||Cochran-Mantel-Haenszel||||
1617996|NCT02393417|2970981|Superiority||Risk Ratio (RR)|1.3828||||0.4307|2-Sided|95.0|0.6191|3.0883|||Cochran-Mantel-Haenszel||||
1617997|NCT02393417|2970982|Superiority||Risk Ratio (RR)|1.7319||||0.0052|2-Sided|95.0|1.1602|2.5854|||Cochran-Mantel-Haenszel||||
1617998|NCT02393417|2970982|Superiority||Risk Ratio (RR)|1.8926||||0.0007|2-Sided|95.0|1.2722|2.8156|||Cochran-Mantel-Haenszel||||
1617999|NCT02393417|2970982|Superiority||Risk Ratio (RR)|1.5706||||0.0329|2-Sided|95.0|1.0184|2.4223|||Cochran-Mantel-Haenszel||||
1618000|NCT02392806|2971017|Superiority||||||>|0.05|||||||t-test, 2 sided||||
1618001|NCT02392624|2971024|Other||||||<|0.0001|||||||One-sample t-test, 2 sided|The p-value from this test was used to evaluate the importance of retreatment after experiencing clinical worsening.||The null hypothesis for this test was that the mean change from the time of retreatment to 12 weeks after retreatment in UAS7 was zero and the alternative hypothesis was that this change was non-zero.|
1618002|NCT02392624|2971025|Other||||||<|0.0001|||||||One-sample t-test, 1 sided|The p-value from this test was used to determine the importance of continued treatment in this study. P-value is one-sided with alpha = 0.05.||The null hypothesis for this test was that the mean change from Week 24 to Week 48 in UAS7 score was >/=5 and the alternative hypothesis was that the mean change from Week 24 to Week 48 in UAS7 score was <5.|
1618003|NCT02392624|2971026|Superiority||Clinical Worsening Rate Difference|-32.1||||0.0004|2-Sided|95.0|-47.9|-14.9|||Chi-squared|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.|
1618004|NCT02392624|2971027|Superiority||||||<|0.0001|||||||Log Rank|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.|
1618005|NCT02392624|2971028|Superiority||Clinical Worsening Rate Difference|-39.4|||<|0.0001|2-Sided|95.0|-54.5|-22.5|||Chi-squared|||For participants who transitioned to open-label omalizumab, data prior to the date of transitioning was used for analysis.|
1618006|NCT02392247|2971089|Superiority or Other||Slope|3.1|||<|0.001|2-Sided|95.0|2.9|3.4||This study was not designed to determine which method is ‘superior’. Statistical significance refers to deviation of slope for perfect agreement (=1) between paired measurements to quantify strength of association .|Deming regression|Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|Slope measured deviation from 1:1 concordance between SEER and TEG with TEG as denominator. Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|A cohort of 50 patients was estimated to capture at least 7 ‘bleeding’ patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements )|
1618007|NCT02392247|2971090|Superiority or Other||Slope|0.34|||<|0.001|2-Sided|95.0|0.26|0.44||This study was not designed to determine which method is ‘superior’.Statistical significance refers to deviation of slope for perfect agreement (=1) between paired measurements to quantify strength of association .|Deming Regression||Slope measured deviation from 1:1 concordance between SEER and TEG with TEG measurement as denominator. Confidence intervals were obtained by bootstrapping 1000 times on the parameters estimates for the slopes, intervals and correlation coefficients|A cohort of 50 patients was estimated to capture at least 7 ‘bleeding’ patients with a likelihood of 95%, assuming a 25% incidence of bleeding, and standard deviation of 20%, to determine maximum clot stiffness within +/- 10% of the mean. This was a descriptive and method-comparison study. Method comparisons were performed according to Clinical Laboratory Science Institute (CLSI) guidelines (Deming regression on paired measurements)|
1618008|NCT02392234|2971093|Superiority||LS Mean Difference|-9.5|||<|0.0001|2-Sided|95.0|-11.7|-7.3|||Linear Mixed Effects Model||||
1618009|NCT02392234|2971093|Superiority||LS Mean Difference|-4.5|||<|0.0001|2-Sided|95.0|-6.7|-2.3|||Linear Mixed Effects Model||||
1618010|NCT02392234|2971094|Superiority||LS Mean Difference|11.4|||<|0.0001|2-Sided|95.0|9.6|13.2|||Linear Mixed Effects Model||||
1618011|NCT02392234|2971094|Superiority||LS Mean Difference|8.1|||<|0.0001|2-Sided|95.0|6.3|9.9|||Linear Mixed Effects Model||||
1618012|NCT02392234|2971096|Superiority||LS Mean Difference|11.1|||<|0.0001|2-Sided|95.0|8.7|13.6|||Linear Mixed Effects Model||||
1618013|NCT02392234|2971096|Superiority||LS Mean Difference|9.7|||<|0.0001|2-Sided|95.0|7.2|12.2|||Linear Mixed Effects Model||||
1618014|NCT02392234|2971097|Superiority||LS Mean Difference|6.8|||<|0.0001|2-Sided|95.0|5.7|7.8|||Linear Mixed Effects Model||||
1618018|NCT02391987|2971119|Superiority|||||||0.73|||||||Cochran-Mantel-Haenszel||||
1618019|NCT02391948|2971123|Other||population average|1056.0|||||2-Sided|95.0|471.0|1665.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model. This analysis combined children in GMFCS Levels III-V.|
1618020|NCT02391948|2971123|Other||population average|3109.0|||||2-Sided|95.0|2502.0|3739.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.|
1618021|NCT02391948|2971123|Other||population average|2815.0|||||2-Sided|95.0|2025.0|3650.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.|
1618022|NCT02391948|2971124|Other||population average|10.0|||||2-Sided|95.0|0.0|35.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model. This analysis combined children in GMFCS Levels III-V.|
1618023|NCT02391948|2971124|Other||population average|100.0|||||2-Sided|95.0|58.0|145.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.|
1618024|NCT02391948|2971124|Other||population average|108.0|||||2-Sided|95.0|67.0|151.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.|
1618025|NCT02391948|2971125|Other||population average|4319.0|||||2-Sided|95.0|3258.0|5443.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.|
1618026|NCT02391948|2971125|Other||population average|5240.0|||||2-Sided|95.0|3874.0|6670.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.|
1618027|NCT02391948|2971126|Other||population average|1858.0|||||2-Sided|95.0|1233.0|2530.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.|
1618028|NCT02391948|2971126|Other||population average|2319.0|||||2-Sided|95.0|1460.0|3218.0||||||The outcome was modelled as a function of age using a linear mixed effects model, and the population value at age 12 years was estimated from the model.|
1618029|NCT02391948|2971130|Other||Odds Ratio (OR)|1.19|||||2-Sided|95.0|0.92|1.53|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of physical therapy services.|
1618030|NCT02391948|2971130|Other||Odds Ratio (OR)|0.86|||||2-Sided|95.0|0.6|1.25|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of speech and language therapy.|
1618031|NCT02391948|2971130|Other||Odds Ratio (OR)|1.1|||||2-Sided|95.0|0.87|1.39|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of speech and language therapy.|
1618032|NCT02391948|2971130|Other||Odds Ratio (OR)|1.03|||||2-Sided|95.0|0.81|1.31|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor amount of speech and language therapy.|
1618033|NCT02391948|2971130|Other||Odds Ratio (OR)|0.95|||||2-Sided|95.0|0.65|1.38|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of occupational therapy.|
1618034|NCT02391948|2971130|Other||Odds Ratio (OR)|1.15|||||2-Sided|95.0|0.89|1.5|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor amount of occupational therapy.|
1618035|NCT02391948|2971130|Other||Odds Ratio (OR)|0.93|||||2-Sided|95.0|0.72|1.21|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life -Self Care outcome for the predictor amount of occupational therapy.|
1618036|NCT02391948|2971130|Other||Odds Ratio (OR)|1.05|||||2-Sided|95.0|0.74|1.48|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor amount of physical therapy services.|
1618037|NCT02391948|2971130|Other||Odds Ratio (OR)|0.9|||||2-Sided|95.0|0.7|1.15|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor amount of physical therapy services.|
1618167|NCT02389816|2971351|Superiority||LS mean difference|-1.81|Standard Error of the Mean|0.753||0.0165|2-Sided|95.0|-3.29|-0.332|||ANCOVA||||
1618038|NCT02391948|2971130|Other||Odds Ratio (OR)|0.97|||||2-Sided|95.0|0.76|1.24|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor focus on participation (structured play/recreation/leisure activities).|
1618039|NCT02391948|2971130|Other||Odds Ratio (OR)|1.1|||||2-Sided|95.0|0.91|1.32|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor focus on participation (structured play/recreation/leisure activities).|
1618040|NCT02391948|2971130|Other||Odds Ratio (OR)|1.09|||||2-Sided|95.0|0.9|1.31|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor focus on participation (structured play/recreation/leisure activities).|
1618041|NCT02391948|2971130|Other||Odds Ratio (OR)|0.89|||||2-Sided|95.0|0.7|1.13|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).|
1618042|NCT02391948|2971130|Other||Odds Ratio (OR)|1.02|||||2-Sided|95.0|0.86|1.22||||||Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).|
1618043|NCT02391948|2971130|Other||Odds Ratio (OR)|1.08|||||2-Sided|95.0|0.9|1.29|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).|
1618044|NCT02391948|2971130|Other||Odds Ratio (OR)|0.87|||||2-Sided|95.0|0.59|1.3|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor parents' perception of needs being met.|
1618045|NCT02391948|2971130|Other||Odds Ratio (OR)|1.13|||||2-Sided|95.0|0.83|1.53|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor parents' perception of needs being met.|
1618046|NCT02391948|2971130|Other||Odds Ratio (OR)|1.37|||||2-Sided|95.0|1.0|1.87|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor parents' perception of needs being met.|
1618047|NCT02391948|2971130|Other||Odds Ratio (OR)|0.83|||||2-Sided|95.0|0.54|1.26|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Six Minute Walk Test outcome for the predictor family-centred service.|
1618048|NCT02391948|2971130|Other||Odds Ratio (OR)|1.06|||||2-Sided|95.0|0.78|1.44|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Early Clinical Assessment of Balance outcome for the predictor family-centred service.|
1618049|NCT02391948|2971130|Other||Odds Ratio (OR)|1.37|||||2-Sided|95.0|1.0|1.88|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Self Care outcome for the predictor family-centred service.|
1618050|NCT02391948|2971130|Other||Odds Ratio (OR)|1.25|||||2-Sided|95.0|0.97|1.6|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of speech and language therapy.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of speech and language therapy.|
1618051|NCT02391948|2971130|Other||Odds Ratio (OR)|0.98|||||2-Sided|95.0|0.74|1.28|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of occupational therapy services.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of occupational therapy.|
1618095|NCT02391584|2971147|Superiority||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value <0.05 was considered significant.|Mixed Models Analysis||||
1618168|NCT02389816|2971352|Superiority||Odds Ratio (OR)|1.7||||0.0418|2-Sided|95.0|1.02|2.834|||Regression, Logistic||||
1618052|NCT02391948|2971130|Other||Odds Ratio (OR)|0.93|||||2-Sided|95.0|0.72|1.58|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in amount of physical therapy services.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor amount of physical therapy services.|
1618053|NCT02391948|2971130|Other||Odds Ratio (OR)|1.3|||||2-Sided|95.0|1.07|1.58|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in focus on participation.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor focus on participation (structured play/recreation/leisure activities).|
1618054|NCT02391948|2971130|Other||Odds Ratio (OR)|1.15|||||2-Sided|95.0|0.96|1.38|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in the amount of focus on environment.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor degree of focus on environment (assistive devices, equipment, home/school modifications).|
1618055|NCT02391948|2971130|Other||Odds Ratio (OR)|1.48|||||2-Sided|95.0|1.07|2.03|||||Country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in parents' perception of needs being met.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor parents' perception of needs being met.|
1618056|NCT02391948|2971130|Other||Odds Ratio (OR)|1.46|||||2-Sided|95.0|1.06|2.02|||||Data from all GMFCS levels was used, country was included as a model covariate. OR represents the odds of children developing 'better than expected' (top 10%) vs 'as expected' (central 80%) for each unit change in family-centredness outcome.|Logistic regression comparing children progressing better than expected to those progressing as expected on the Child Engagement in Daily Life - Participation outcome for the predictor family-centred service.|
1618057|NCT02391948|2971131|Other||mean population value age 12|14.5|||||2-Sided|95.0|12.4|16.5|||||||
1618058|NCT02391948|2971131|Other||mean population value age 12|37.9|||||2-Sided|95.0|35.6|40.3|||||||
1618059|NCT02391948|2971131|Other||mean population value age 12|60.5|||||2-Sided|95.0|57.3|63.3|||||||
1618060|NCT02391948|2971131|Other||mean population value age 12|66.1|||||2-Sided|95.0|63.5|68.5|||||||
1618061|NCT02391948|2971131|Other||mean population value age 12|78.3|||||2-Sided|95.0|76.0|80.4|||||||
1618062|NCT02391948|2971132|Other||mean population value age 12|51.9|||||2-Sided|95.0|50.2|53.6|||||||
1618063|NCT02391948|2971132|Other||mean population value age 12|58.2|||||2-Sided|95.0|56.7|59.7|||||||
1618064|NCT02391948|2971132|Other||mean population value age 12|62.9|||||2-Sided|95.0|60.9|65.0|||||||
1618065|NCT02391948|2971132|Other||mean population value age 12|62.1|||||2-Sided|95.0|59.4|65.0|||||||
1618066|NCT02391948|2971132|Other||mean population value age 12|70.6|||||2-Sided|95.0|69.1|72.0|||||||
1618067|NCT02391948|2971133|Other||mean population value|2.33|||||2-Sided|95.0|2.08|2.6|||||||
1618068|NCT02391948|2971133|Other||mean population value|1.38|||||2-Sided|95.0|1.12|1.65|||||||
1618069|NCT02391948|2971133|Other||mean population value|0.68|||||2-Sided|95.0|0.48|0.89|||||||
1618070|NCT02391948|2971133|Other||mean population value|1.1|||||2-Sided|95.0|0.91|1.3|||||||
1618071|NCT02391948|2971133|Other||mean population value|0.59|||||2-Sided|9.0|0.47|0.72|||||||
1618072|NCT02391948|2971134|Other||mean population value|1.79|||||2-Sided|95.0|1.67|1.91|||||||
1618073|NCT02391948|2971134|Other||mean population value|2.8|||||2-Sided|95.0|2.67|2.93|||||||
1618074|NCT02391948|2971134|Other||mean population value|3.23|||||2-Sided|95.0|3.08|3.37|||||||
1618075|NCT02391948|2971134|Other||mean population value|3.49|||||2-Sided|95.0|3.39|3.6|||||||
1618076|NCT02391948|2971134|Other||mean population value|3.99|||||2-Sided|95.0|3.91|4.07|||||||
1618077|NCT02391948|2971135|Other||mean population value|592.62|||||2-Sided|95.0|533.79|652.72|||||||
1618078|NCT02391948|2971135|Other||mean population value|1096.33|||||2-Sided|95.0|1028.8|1158.62|||||||
1618079|NCT02391948|2971135|Other||mean population value|1362.3|||||2-Sided|95.0|1313.6|1410.7|||||||
1618080|NCT02391948|2971136|Other||mean population value|1.59|||||2-Sided|95.0|1.44|1.75|||||||
1618081|NCT02391948|2971136|Other||mean population value|2.95|||||2-Sided|95.0|2.73|3.19|||||||
1618082|NCT02391948|2971136|Other||mean population value|3.99|||||2-Sided|95.0|3.75|4.25|||||||
1618083|NCT02391948|2971136|Other||mean population value|4.1|||||2-Sided|95.0|3.99|4.2|||||||
1618084|NCT02391948|2971136|Other||mean population value|4.49|||||2-Sided|95.0|4.43|4.54|||||||
1618085|NCT02391948|2971137|Other||mean population value age 12|2.16|||||2-Sided|95.0|2.01|2.31|||||||
1618086|NCT02391948|2971137|Other||mean population value age 12|1.38|||||2-Sided|95.0|1.22|1.54|||||||
1618087|NCT02391948|2971137|Other||mean population value age 12|0.93|||||2-Sided|95.0|0.79|1.07|||||||
1618088|NCT02391948|2971137|Other||mean population value age 12|0.68|||||2-Sided|95.0|0.6|0.77|||||||
1618089|NCT02391948|2971137|Other||mean population value age 12|0.44|||||2-Sided|95.0|0.38|0.49|||||||
1618090|NCT02391948|2971138|Other||mean population value age 12|6.48|||||2-Sided|95.0|5.66|7.38|||||||
1618091|NCT02391948|2971138|Other||mean population value age 12|25.3|||||2-Sided|95.0|23.7|27.0|||||||
1618092|NCT02391948|2971138|Other||mean population value age 12|50.1|||||2-Sided|95.0|46.5|53.6|||||||
1618093|NCT02391948|2971138|Other||mean population value age 12|89.1|||||2-Sided|95.0|86.6|91.1|||||||
1618094|NCT02391948|2971138|Other||mean population value age 12|98.3|||||2-Sided|95.0|97.8|98.6|||||||
1618548|NCT02373098|2972515|Other|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||IL13|
1618096|NCT02391584|2971148|Superiority||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value <0.05 was considered significant.|Mixed Models Analysis||||
1618097|NCT02391584|2971149|Superiority||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value <0.05 was considered significant.|Mixed Models Analysis||||
1618098|NCT02391584|2971150|Superiority||||||<|0.0001||||||Dunnett's t-test was used for the multiple comparisons with baseline. A p value <0.05 was considered significant.|Mixed Models Analysis||||
1618099|NCT02391584|2971154|Superiority||||||<|0.0001||||||p<0.025 was considered significant.|t-test, 1 sided||||
1618100|NCT02391363|2971162|Superiority|||||||0.54||||||Parameter estimate for treatment group = -0.29 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618101|NCT02391363|2971163|Superiority|||||||0.55||||||Parameter estimate for treatment group = -0.28 (SE = 0.46). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month psychological service use, controlling for baseline psychological service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618102|NCT02391363|2971164|Superiority|||||||0.85||||||Parameter estimate for treatment group = 0.09 (SE = 0.47). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618103|NCT02391363|2971165|Superiority|||||||0.42||||||Parameter estimate for treatment group = 0.42 (SE = 0.51). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month social service use, controlling for baseline social service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618104|NCT02391363|2971166|Superiority|||||||0.001||||||Parameter estimate for treatment group = 2.96 (SE = 0.91). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618105|NCT02391363|2971167|Superiority|||||||0.04||||||Parameter estimate for treatment group = 1.56 (SE = 0.74). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 6 month hospital admissions, controlling for baseline hospital admissions.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618106|NCT02391363|2971168|Superiority|||||||0.04||||||Parameter estimate for treatment group = 1.79 (SE = 0.85). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.||"We expected to reject the null hypothesis of no treatment group difference in 9 month health service use, controlling for baseline health service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618107|NCT02391363|2971169|Superiority|"We expected to reject the null hypothesis of no treatment group difference in 6 month health service use, controlling for baseline health service use.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"||||||0.52||||||Parameter estimate for treatment group = 0.40 (SE = 0.63). Controlled for baseline health service use, ERS-expectancies and race/ethnicity|Regression, Logistic|ITT analyses with PROC MI AND MI ANALYZE in conjunction with multiple logistic regression.|||
1618108|NCT02391363|2971170|Superiority|||||||0.96||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618165|NCT02389816|2971350|Superiority||LS mean difference|-0.36|Standard Error of the Mean|0.12||0.0031|2-Sided|95.0|-0.59|-0.121|||ANCOVA||||
1618109|NCT02391363|2971171|Superiority|||||||0.31||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 1.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PCL-5, controlling for baseline PCL-5.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618110|NCT02391363|2971172|Superiority|||||||0.88||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F= 0.02 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618111|NCT02391363|2971173|Superiority|||||||0.98||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618112|NCT02391363|2971174|Superiority|||||||0.94||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.00 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618113|NCT02391363|2971175|Superiority|||||||0.64||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F= 0.23 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month SF-12, controlling for baseline SF-12.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618114|NCT02391363|2971176|Superiority|||||||0.89||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618115|NCT02391363|2971177|Superiority|||||||0.59||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.29 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618116|NCT02391363|2971178|Superiority|||||||0.92||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = .01(Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618117|NCT02391363|2971179|Superiority|||||||0.52||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month LL-FDI, controlling for baseline LL-FDI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618118|NCT02391363|2971180|Superiority|||||||0.35||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.88 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618119|NCT02391363|2971181|Superiority|||||||0.64||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.22 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month ISI, controlling for baseline ISI.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618120|NCT02391363|2971182|Superiority|||||||0.59||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.30 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618121|NCT02391363|2971183|Superiority|||||||0.14||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 2.19 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GDS-SF, controlling for baseline GDS-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618122|NCT02391363|2971184|Superiority|||||||0.29||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 1.14 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618123|NCT02391363|2971185|Superiority|||||||0.52||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.42 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PHQ-8, controlling for baseline PHQ-8.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618124|NCT02391363|2971186|Superiority|||||||0.13||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 2.37 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618125|NCT02391363|2971187|Superiority|||||||0.45||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.59 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAI-SF, controlling for baseline GAI-SF.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618126|NCT02391363|2971188|Superiority|||||||0.08||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 3.20 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618127|NCT02391363|2971189|Superiority|||||||0.34||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.92. (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month GAD-7, controlling for baseline GAD-7.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618128|NCT02391363|2971190|Superiority|||||||0.07||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 3.50 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 9 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate"|
1618129|NCT02391363|2971191|Superiority|||||||0.77||||||P-value for treatment-group effect (CL vs ECC)|ANCOVA|Treatment group F = 0.08 (Numerator df = 1, Denominator df varies, as multiple imputation was used).||"Analyses were ITT using PROC MI and PROC MI ANALYZE in conjunction with ANCOVA. We expected to reject the null hypothesis of no treatment group difference in 6 month PSWQ-A, controlling for baseline PSWQ-A.~Race/ethnicity and ERS-expectancies significantly differed between groups at baseline and were included as covariates.~A total of 134 participants allowed for 80% power to detect moderate group differences (d=.49) in primary and secondary outcomes given a 2-tailed type 1 error rate of .05."|
1618130|NCT02391116|2971212|Other||Percentage Difference|26.3|||||2-Sided|90.0|-44.3|77.6|||||ORR difference in PPS (N=40): ORR in Unclassifiable subgroup minus ORR in ABC / GCB subgroup (i.e. combined ABC subgroup and GCB subgroup)||
1618131|NCT02391116|2971212|Other||Percentage Difference|12.9|||||2-Sided|90.0|-42.4|63.2|||||ORR difference in FAS (N=52): ORR in Unclassifiable subgroup minus ORR in ABC / GCB subgroup (i.e. combined ABC subgroup and GCB subgroup)||
1618166|NCT02389816|2971351|Superiority||LS mean difference|-1.79|Standard Error of the Mean|0.759||0.019|2-Sided|95.0|-3.278|-0.295|||ANCOVA||||
1618132|NCT02391116|2971212|Other||Percentage Difference|-25.3|||||2-Sided|90.0|-49.1|1.1|||||ORR difference in PPS (N=40): ORR in GCB subgroup minus ORR in non-GCB subgroup (i.e. combined ABC subgroup and Unclassifiable subgroup)||
1618133|NCT02391116|2971212|Other||Percentage Difference|-18.5|||||2-Sided|90.0|-40.1|4.6|||||ORR difference in FAS (N=52): ORR in GCB subgroup minus ORR in non-GCB subgroup (i.e. combined ABC subgroup and Unclassifiable subgroup)||
1618134|NCT02391116|2971212|Other||Percentage Difference|20.8|||||2-Sided|90.0|-6.8|46.2|||||ORR difference in PPS (N=40): ORR in ABC subgroup minus ORR in non-ABC group (i.e. combined GCB subgroup and Unclassifiable subgroup)||
1618135|NCT02391116|2971212|Other||Percentage Difference|16.4|||||2-Sided|90.0|-7.2|39.1|||||ORR difference in FAS (N=52): ORR in ABC subgroup minus ORR in non-ABC group (i.e. combined GCB subgroup and Unclassifiable subgroup)||
1618136|NCT02391116|2971213|Other||Percentage Difference|0.0|||||2-Sided|90.0|-33.5|33.5|||||ORR difference in PPS (N=40): ORR in CD79b mutant subgroup minus ORR in CD79b wild-type subgroup||
1618137|NCT02391116|2971213|Other||Percentage Difference|2.2|||||2-Sided|90.0|-28.7|32.9|||||ORR difference in FAS (N=54): ORR in CD79b mutant subgroup minus ORR in CD79b wild-type subgroup||
1618138|NCT02390791|2971266|Superiority|||||||0.71|||||||generalized linear model||||
1618139|NCT02390791|2971267|Superiority|||||||0.48|||||||generalized linear model||||
1618140|NCT02390791|2971268|Superiority|||||||0.15|||||||Chi-squared||||
1618141|NCT02390791|2971269|Superiority|||||||0.88|||||||Wilcoxon (Mann-Whitney)||||
1618142|NCT02390791|2971270|Superiority|||||||0.94|||||||Wilcoxon (Mann-Whitney)||||
1618143|NCT02390791|2971271|Superiority|||||||0.13|||||||Wilcoxon (Mann-Whitney)||||
1618144|NCT02390791|2971272|Superiority|||||||0.69|||||||Wilcoxon (Mann-Whitney)||||
1618145|NCT02390791|2971273|Superiority|||||||0.85|||||||Wilcoxon (Mann-Whitney)||||
1618146|NCT02390791|2971274|Superiority|||||||0.89|||||||Wilcoxon (Mann-Whitney)||||
1618147|NCT02390791|2971275|Superiority|||||||0.04|||||||generalized linear model|assuming a Poisson distribution with a log link function|||
1618148|NCT02390557|2971276|Superiority||Mean Difference (Final Values)|7.4||||0.069|2-Sided||||||Chi-squared, Corrected|||We compared change in perception of quality of health care between Control v YES Health, wave 1 v Wave 2|
1618149|NCT02390557|2971276|Superiority||Mean Difference (Final Values)|10.7||||0.074|2-Sided||||||Chi-squared, Corrected|||we had a prior hypothesis that the survey intervention would be associated with a larger increase in perceived quality of health care compared with control from Wave 1 to Wave 2|
1618150|NCT02389946|2971312|Other|||||||0.415|||||||Fisher Exact||||
1618151|NCT02389946|2971313|Non-Inferiority|Non-inferiority of the 12-month TLF rate for the Orsiro stent vs. the Xience stent was assessed as the primary endpoint. The null hypothesis H0 was that the Orsiro stent would have a primary endpoint (12-month TLF) rate equal to or exceeding that of the Xience group by the non-inferiority margin or more. The alternative hypothesis HA was that the Orsiro stent would have a 12-month TLF rate less than the Xience group rate plus the non-inferiority margin of 3.85%.|Posterior Probability of non-inferioriry|100.0|||||2-Sided|||||||||Bayesian calculation using a hierarchical model to incorporate data from previous BIOFLOW-II and BIOFLOW-IV trials.|
1618152|NCT02389894|2971333|Superiority||Risk Difference (RD)|-2.8||||0.61|2-Sided|95.0|-13.5|7.9|||Chi-squared||The absolute difference was computed as Cardiogard minus control||
1618153|NCT02389894|2971333|Superiority||Risk Difference (RD)|9.7||||0.08|2-Sided|95.0|-1.2|20.5|||Chi-squared||The absolute difference was computed as Embol-x minus control||
1618154|NCT02389894|2971334|Superiority||Risk Difference (RD)|1.3||||0.84|2-Sided|95.0|-11.2|13.8||The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.|Chi-squared||The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Cardiogard minus control.|A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.|
1618155|NCT02389894|2971334|Superiority||Risk Difference (RD)|6.9||||0.22|2-Sided|95.0|-4.2|17.9|||Chi-squared|The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism.|The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Embol-x minus control|A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint.|
1618156|NCT02389816|2971346|Superiority||LS mean difference|-1.27|Standard Error of the Mean|0.332||0.0001|2-Sided|95.0|-1.922|-0.619|||ANCOVA||||
1618157|NCT02389816|2971346|Superiority||LS mean difference|-0.87|Standard Error of the Mean|0.329||0.0089|2-Sided|95.0|-1.512|-0.218|||ANCOVA||||
1618158|NCT02389816|2971347|Superiority||LS mean difference|-0.11|Standard Error of the Mean|0.891||0.9011|2-Sided|95.0|-1.862|1.641|||ANCOVA||||
1618159|NCT02389816|2971347|Superiority||LS mean difference|-0.79|Standard Error of the Mean|0.893||0.3793|2-Sided|95.0|-2.539|0.968|||ANCOVA||||
1618160|NCT02389816|2971348|Superiority||LS mean difference|-1.57|Standard Error of the Mean|0.628||0.0126|2-Sided|95.0|-2.807|-0.339|||ANCOVA||||
1618161|NCT02389816|2971348|Superiority||LS mean difference|-1.34|Standard Error of the Mean|0.621||0.0311|2-Sided|95.0|-2.564|-0.122|||ANCOVA||||
1618162|NCT02389816|2971349|Superiority||LS mean difference|-0.29|Standard Error of the Mean|0.124||0.0179|2-Sided|95.0|-0.537|-0.051|||ANCOVA||||
1618163|NCT02389816|2971349|Superiority||LS mean difference|-0.23|Standard Error of the Mean|0.123||0.0609|2-Sided|95.0|-0.474|0.011|||ANCOVA||||
1618164|NCT02389816|2971350|Superiority||LS mean difference|-0.39|Standard Error of the Mean|0.12||0.0011|2-Sided|95.0|-0.629|-0.158|||ANCOVA||||
1618169|NCT02389816|2971352|Superiority||Odds Ratio (OR)|1.839||||0.0186|2-Sided|95.0|1.107|3.054|||Regression, Logistic||||
1618170|NCT02389816|2971353|Superiority||Odds Ratio (OR)|1.788||||0.011||95.0|1.143|2.799|||Regression, Logistic||||
1618171|NCT02389816|2971353|Superiority||Odds Ratio (OR)|1.621||||0.0341|2-Sided|95.0|1.037|2.533|||Regression, Logistic||||
1618172|NCT02389816|2971354|Superiority||LS mean difference|-3.07|Standard Error of the Mean|1.003||0.0023|2-Sided|95.0|-5.05|-1.1|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)|||
1618173|NCT02389816|2971354|Superiority||Least square (LS) mean difference|-2.66|Standard Error of the Mean|0.999||0.008|2-Sided|95.0|-4.63|-0.7|||Mixed Models Analysis|Mixed Models for Repeated Measures (MMRM)|||
1618174|NCT02389725|2971359|Superiority|||||||0.32|||||||Wilcoxon (Mann-Whitney)||||
1618175|NCT02389725|2971360|Superiority|||||||0.67|||||||Wilcoxon (Mann-Whitney)||||
1618176|NCT02389725|2971361|Superiority|||||||0.87|||||||Wilcoxon (Mann-Whitney)||||
1618177|NCT02389725|2971362|Superiority|||||||0.95|||||||Wilcoxon (Mann-Whitney)||||
1618178|NCT02389621|2971372|Superiority|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|||||<|0.0001|||||||Wilcoxon rank sum test||||
1618179|NCT02389621|2971373|Superiority|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.||||||0.0002|||||||van Elteren test|van Elteren test stratified by platelet transfusion during the study.|||
1618180|NCT02389621|2971374|Superiority|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|Difference|52.5|||<|0.0001|2-Sided|95.0|42.0|62.9|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of platelet count at randomization and the planned primary invasive procedure.|||
1618181|NCT02389621|2971375|Superiority|A gatekeeping procedure was employed for sequentially testing the prespecified important secondary endpoints, identified as the most clinically relevant endpoints. If the primary endpoint was statistically significant, the secondary endpoints were tested at the 0.05 level (2-sided) in sequence.|Difference|34.8|||<|0.0001|2-Sided|95.0|22.8|46.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors of platelet count at randomization and the planned primary invasive procedure.|||
1618182|NCT02389621|2971376|Superiority||Difference|36.7|||<|0.0001|2-Sided|95.0|24.9|48.5||Statistical tests were performed at a 2-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Adjusted using the stratification factors of platelet count at randomization and the planned primary invasive procedure.|||
1618183|NCT02389452|2971390|Superiority or Other||||||<|0.0001|||||||Paired t-test||||
1618184|NCT02388997|2971407|Superiority|||||||0.037||||||The p value is based on the fold change (ratio) of the geometric means of the time (days) to peak symptoms among asthmatics in the omalizumab/placebo treatment groups.|2-sample t-test on the log scale||||
1618185|NCT02388997|2971409|Superiority|||||||0.6|||||||2-sample t-test with unequal variances||||
1618186|NCT02388997|2971410|Superiority|||||||0.55|||||||2-sample t-test with unequal variances||||
1618187|NCT02388997|2971411|Superiority|||||||0.87|||||||2-sample t-test with unequal variances||||
1618188|NCT02388997|2971412|Superiority|||||||0.58|||||||2-sample t-test with unequal variances||||
1618189|NCT02388997|2971413|Superiority|||||||0.59|||||||2-sample t-test with unequal variences||||
1618190|NCT02388724|2971446|Superiority||Difference in percentages|1.8|||||2-Sided|95.0|-4.763|8.395||||||4 Weeks|
1618191|NCT02388724|2971446|Superiority||Difference in percentages|7.2|||||2-Sided|95.0|-1.054|15.371||||||2 Weeks|
1618192|NCT02388724|2971447|Non-Inferiority|If the lower bound of the 95% confidence intervals of the difference was more than -10% (non-inferiority margin), non-inferiority for Vonoprazan relative to Lansoprazole was declared.|Difference in percentages|1.1|||||2-Sided|95.0|-3.822|6.087|||||||
1618193|NCT02388295|2971471|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.36||0.45|2-Sided|||||no adjustment|ANOVA||lookin for negative difference compared to placebo|Secondary objective|
1618194|NCT02388295|2971471|Superiority or Other||Mean Difference (Final Values)|0.35|Standard Error of the Mean|0.34||0.32|2-Sided|||||no adjustment|ANOVA||Looking for negative direction to indicate treatment better than placebo|Secondary objective - comparison to placebo|
1618195|NCT02388295|2971471|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.25||0.68|1-Sided||||||ANOVA|no adjustments|larger negagtive values (powereed to detect -0.50)|Change from baseline|
1618196|NCT02388295|2971471|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.25||0.91|1-Sided|||||not adjusted|ANOVA||larger negative values (powered to detect -0.50)|Change from baseline|
1618197|NCT02388295|2971471|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.24||0.13|1-Sided|||||Not adjusted|ANOVA||larger negative values (powered to detect -0.50)|Change from baseline within treatment arm|
1618198|NCT02387970|2971502|Superiority|||||||0.854|||||||t-test, 2 sided||||
1618199|NCT02387970|2971503|Superiority|||||||0.248|||||||t-test, 2 sided||||
1618200|NCT02387970|2971504|Superiority|||||||0.121|||||||t-test, 2 sided||||
1618201|NCT02387970|2971505|Superiority|||||||0.297|||||||t-test, 2 sided||||
1618202|NCT02387970|2971506|Superiority|||||||0.165|||||||t-test, 2 sided||||
1618203|NCT02387970|2971507|Superiority|||||||0.235|||||||t-test, 2 sided||||
1618204|NCT02387970|2971508|Superiority|||||||0.088|||||||t-test, 2 sided||||
1618205|NCT02387749|2971538|Superiority|||||||0.005|||||||Chi-squared, Corrected||||
1618206|NCT02387710|2971541|Other||||||>|0.5|||||||Wilcoxon (Mann-Whitney)||||
1618273|NCT02382744|2971817|Superiority or Other||Difference between means (s)|107.0|||<|0.0001|2-Sided|95.0|61.0|153.0|||t-test, 2 sided||||
1618207|NCT02387476|2971564|Non-Inferiority|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|Mean Difference (Final Values)|0.3|Standard Deviation|0.36|<|0.001|2-Sided|95.0|-0.4|1.0||The p-value to test non-inferiority of FRESCA Mask compared with CPAP Mask (FRESCA-CPAP<5 units) assumes a 1-sided test using a level of significance of 2.5% and NI margin of 5 units.|t-test, 1 sided||The mean ODI values are rounded to a single decimal point value in the text of the table (1.4 and 1.1, respectively) to ensure consistency with ODI reporting standards.|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|
1618208|NCT02387476|2971565|Non-Inferiority|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|Mean Difference (Final Values)|0.6|Standard Deviation|1.13|<|0.001|2-Sided|95.0|-1.7|2.9||The p-value to test non-inferiority of FRESCA Mask compared with CPAP Mask (FRESCA-CPAP<5 units) assumes a 1-sided test using a level of significance of 2.5% and NI margin of 5 units.|t-test, 1 sided||The mean AHI is rounded to a single decimal point in the text of the report (3.0 and 2.4, respectively), in order to be consistent with standard reporting of AHI.|This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.|
1618209|NCT02387372|2971579|Other||GMR|1.2|||||2-Sided|90.0|1.09|1.33|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose|
1618210|NCT02387372|2971579|Other||Geometric least squares mean ratio (GMR)|1.71|||||2-Sided|90.0|1.51|1.95|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose|
1618211|NCT02387372|2971580|Other||GMR|1.24|||||2-Sided|90.0|1.11|1.39|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose|
1618212|NCT02387372|2971580|Other||Geometric least squares mean ratio (GMR)|1.61|||||2-Sided|90.0|1.44|1.81|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose|
1618213|NCT02387372|2971582|Other||GMR|1.33|||||2-Sided|90.0|1.14|1.55|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose|
1618214|NCT02387372|2971582|Other||Geometric least squares mean ratio (GMR)|1.71|||||2-Sided|90.0|1.5|1.96|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose|
1618215|NCT02387372|2971585|Other||GMR|1.15|||||2-Sided|90.0|1.03|1.29|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose|
1618216|NCT02387372|2971585|Other||Geometric least squares mean ratio (GMR)|1.38|||||2-Sided|90.0|1.21|1.56|||||Ratio of Last Dose/First Dose|Accumulation Ratio of Last Dose/First Dose|
1618217|NCT02386189|2971607|Superiority||Mean Difference (Final Values)|-0.5|Standard Deviation|8.9||0.89|2-Sided||||||t-test, 2 sided||||
1618218|NCT02386189|2971608|Superiority||Mean Difference (Final Values)|-3.6|Standard Deviation|7.1||0.18|2-Sided||||||t-test, 2 sided||||
1618219|NCT02386189|2971609|Superiority||Mean Difference (Net)|-0.01|Standard Deviation|0.15||0.75|2-Sided||||||t-test, 2 sided||||
1618220|NCT02386189|2971610|Superiority|||||||0.17|||||||Fisher Exact||||
1618221|NCT02386189|2971611|Superiority||Mean Difference (Net)|0.28|Standard Deviation|2.7||0.71|2-Sided||||||t-test, 2 sided||||
1618222|NCT02386189|2971612|Superiority||Mean Difference (Net)|2.91|Standard Deviation|5.5||0.06|2-Sided||||||t-test, 2 sided||||
1618223|NCT02386189|2971613|Superiority||Mean Difference (Net)|-4.65|Standard Deviation|7.3||0.02|2-Sided||||||t-test, 2 sided|||The t-test was conducted on change between baseline and 12-month follow-up.|
1618224|NCT02384941|2971686|Superiority||Least squares mean difference|-0.8|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-1.0|-0.5||Threshold for significance < 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1618225|NCT02384941|2971687|Superiority||Least squares mean difference|2.5|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|1.8|3.3||Threshold for significance < 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1618226|NCT02384941|2971688|Superiority||Least squares mean difference|-0.99|Standard Error of the Mean|0.26|<|0.001|2-Sided|95.0|-1.5|-0.48||Threshold for significance < 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1618227|NCT02384941|2971689|Superiority||Least squares mean difference|-3.3|Standard Error of the Mean|0.916|<|0.001|2-Sided|95.0|-5.09|-1.5||Threshold for significance < 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1618228|NCT02384941|2971689|Superiority||Least squares mean difference|-1.5|Standard Error of the Mean|0.917|<|0.1|2-Sided|95.0|-3.3|0.3||Threshold for significance < 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1618229|NCT02384941|2971690|Superiority||Least squares mean difference|-3.45|Standard Error of the Mean|0.256|<|0.001|2-Sided|95.0|-3.95|-2.94||Threshold for significance < 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1618295|NCT02380859|2971884|Superiority|||||||0.005|||||||ANOVA|||Group (real, sham) x Time (pre, 1d post) x Stepping Direction (forward, backward) ANOVA|
1618230|NCT02384941|2971690|Superiority||Least squares mean difference|-2.35|Standard Error of the Mean|0.256|<|0.001|2-Sided|95.0|-2.85|-1.85||Threshold for significance < 0.05.|MMRM|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1618231|NCT02384941|2971691|Superiority||Percentage difference|21.9|||<|0.001|2-Sided|95.0|14.1|29.64||Threshold for significance < 0.05.|Cochran-Mantel-Haenszel|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant for the relevant compared arms).|
1618232|NCT02384941|2971691|Superiority||Percentage difference|11.8|||<|0.002|2-Sided|95.0|4.28|19.36||Threshold for significance < 0.05.|Cochran-Mantel-Haenszel|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints were reported. The hierarchical testing sequence continued only when previous endpoint of each treatment comparison was statistically significant at 0.05 level.|
1618233|NCT02384941|2971692|Superiority||Least squares mean difference|-0.41|Standard Error of the Mean|0.047|<|0.001|2-Sided|95.0||||Threshold for significance < 0.05.|MMRM||||
1618234|NCT02384941|2971692|Superiority||Least squares mean difference|-0.36|Standard Error of the Mean|0.047|<|0.001|2-Sided|||||Threshold for significance < 0.05.|MMRM||||
1618235|NCT02384538|2971693|Other||LS Mean Difference|0.52||||0.212|2-Sided|95.0|-0.3|1.336||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16|
1618236|NCT02384538|2971694|Other||LS Mean Difference|0.45||||0.281|2-Sided|95.0|-0.373|1.272||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16|
1618237|NCT02384538|2971695|Other||LS Mean Difference|4.25||||0.387|2-Sided|95.0|-5.448|13.945||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16|
1618238|NCT02384538|2971696|Other||LS Mean Difference|0.15||||0.719|2-Sided|95.0|-0.677|0.979||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16|
1618239|NCT02384538|2971697|Other||LS Mean Difference|2.55||||0.383|2-Sided|95.0|-3.214|8.308||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA|||Week 16|
1618240|NCT02384538|2971699|Other||LS Mean Difference|1.52||||0.386|2-Sided|95.0|-1.944|4.99||P-value for test of difference in change from baseline between ABT-981 dose group and placebo is from an ANCOVA model with treatment group and country as the main factors and baseline as a covariate.|ANCOVA||||
1618241|NCT02384460|2971700|Other|Pre-specified.|Odds Ratio (OR)|0.596||||0.098|2-Sided|95.0|0.323|1.1||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||The proportion of participants experiencing improvement in pain versus non-improvement (including missing) was compared between the 2 treatment groups for Day 7 using the logistic regression model with baseline pain score and EB type as covariates.|
1618242|NCT02384460|2971701|Other|Pre-specified.|Odds Ratio (OR)|1.445||||0.262|2-Sided|95.0|0.759|2.752||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||The proportion of participants experiencing improvement in itching versus non-improvement (including missing) was compared between the 2 treatment groups for Day 7 using the logistic regression model with baseline itching score, and EB type as covariates.|
1618243|NCT02384460|2971702|Other|Multiple imputation was used by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a linear regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline BSAI of lesional skin, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|LS means difference|0.128||||0.9|2-Sided|95.0|-2.116|1.861||The p-value is calculated based on the hypothesis testing for the difference of LS-means between treatment and placebo.|Mixed Models Analysis|||MMRM Analysis. The MMRM approach (using REML estimation) was used on each multiply-imputed data set. The model included treatment, baseline BSAI of lesional skin, EB type, visit, and visit-treatment interaction as the fixed effects.|
1618244|NCT02384460|2971703|Other|Multiple imputation was used by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a linear regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline BSAI of lesional skin, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|LS means difference|0.682||||0.706|2-Sided|95.0|-2.873|4.238||The p-value is calculated based on the hypothesis testing for the difference of least-squares (LS)-means between treatment and placebo.|Mixed Models Analysis|||Mixed Model Repeated Measures (MMRM) Analysis. The MMRM approach (using restricted maximum likelihood [REML] estimation) was used on each multiply-imputed data set. The model included treatment, baseline BSAI of lesional skin, EB type, visit, and visit-treatment interaction as the fixed effects.|
1618245|NCT02384460|2971704|Other|Multiple imputation was implemented by 2 steps. The first step used MCMC to get monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|Odds Ratio (OR)|0.891||||0.802|2-Sided|95.0|0.436|1.821||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Logistic Regression Analysis at Month 2 visit. Comparison between treatment groups of complete closure of target wound within 2 months was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.|
1618296|NCT02380742|2971886|Superiority or Other||Mean Difference (Final Values)|-1.07|Standard Error of the Mean|0.63||0.09|2-Sided||||||ANCOVA|||The null hypothesis was that patients' pain scores at insertion were the same between the lidocaine and placebo groups after controlling for baseline pain.|
1618549|NCT02373098|2972515|Other|||||||0.934|||||||Wilcoxon (Mann-Whitney)|||IL8|
1618246|NCT02384460|2971704|Other|Multiple imputation was implemented by 2 steps. The first step used MCMC to get the monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation method: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 01005 and the number of imputations was 5.|Odds Ratio (OR)|1.633||||0.212|2-Sided|95.0|0.758|3.517||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Logistic Regression Analysis at Month 1 visit. Comparison between treatment groups of complete closure of target wound within 1 month was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.|
1618247|NCT02384460|2971705|Other|Multiple imputation was implemented by 2 steps. The first step used Markov Chain Monte Carlo (MCMC) to get monotonic missing data pattern. In the second step, a logistic regression model was used, with the following covariates included in the imputation model: treatment, EB type, baseline target wound size, target wound age, and non-missing data from earlier time points. The seed number was 010005 and the number of imputations was 5.|Odds Ratio (OR)|0.733||||0.39|2-Sided|95.0|0.365|1.474||p-value is from the logistic regression model for treatment comparison.|Regression, Logistic|||Comparison between treatment groups of complete closure of target wound within 3 months was performed using a logistic regression model with multiple imputation with EB type, baseline target wound size, and baseline target wound age as covariates.|
1618248|NCT02384460|2971706|Other||Hazard Ratio (HR)|1.004||||0.985|2-Sided|95.0|0.651|1.549||p-value is for Type 3 chi-square test for comparison between treatments.|Cox Model Analysis|||Cox proportional hazards model compares treatment groups with baseline target wound size, target wound age, and EB type as covariates.|
1618249|NCT02384070|2971722|Superiority or Other|||||||1||||||The prior threshold for statistical significance was P < 0.05|ANOVA||||
1618250|NCT02384070|2971722|Superiority or Other|||||||1||||||Analysis of the variance was used and Chi-square test for categorical variables. A sample size was calculated for a 95% confidence level and a power of 80%, assuming a 10% difference between groups.|ANOVA||||
1618251|NCT02383966|2971727|Other||Odds Ratio (OR)|2.14|||||2-Sided|95.0|1.15|3.95|||||||
1618252|NCT02383966|2971728|Other||Odds Ratio (OR)|2.76|||||2-Sided|95.0|1.52|5.45|||||||
1618253|NCT02383966|2971729|Other||Hazard Ratio (HR)|0.705|||||2-Sided|95.0|0.502|0.991|||||||
1618254|NCT02383966|2971730|Other||Hazard Ratio (HR)|0.568|||||2-Sided|95.0|0.406|0.795|||||||
1618255|NCT02383966|2971731|Other||Hazard Ratio (HR)|0.566|||||2-Sided|95.0|0.4|0.803|||||||
1618256|NCT02383940|2971736|Superiority||Least squares mean difference|-0.35|Standard Error of the Mean|0.207||0.1|2-Sided|95.0|-0.76|0.06||Threshold for significance = 0.05|MMRM||Difference is sotagliflozin – placebo|Between-group comparison was based on MMRM model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (<=10%, >10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.|
1618257|NCT02383862|2971747|Superiority||Mean Difference (Final Values)|1.67|Standard Error of the Mean|1.36||0.222|2-Sided|95.0|-1.0|4.35|||t-test, 2 sided||||
1618258|NCT02383862|2971748|Superiority||Mean Difference (Final Values)|1.49|Standard Error of the Mean|1.1||0.174|2-Sided|95.0|-0.66|3.65|||t-test, 2 sided||||
1618259|NCT02383862|2971749|Superiority||Mean Difference (Final Values)|0.83|Standard Error of the Mean|1.16||0.471|2-Sided|95.0|-1.44|3.11|||t-test, 2 sided||||
1618260|NCT02383862|2971750|Superiority||Mean Difference (Final Values)|0.65|Standard Error of the Mean|1.05||0.539|2-Sided|95.0|-1.41|2.7|||t-test, 2 sided||||
1618261|NCT02383862|2971751|Superiority||Mean Difference (Final Values)|0.84|Standard Error of the Mean|1.05||0.425|2-Sided|95.0|-1.23|2.91|||t-test, 2 sided||||
1618262|NCT02383862|2971752|Superiority||Mean Difference (Final Values)|1.1|Standard Error of the Mean|0.79||0.165|2-Sided|95.0|-0.45|2.64|||t-test, 2 sided||||
1618263|NCT02383589|2971765|Superiority||Difference in Estimated Means|-2.872||||0.0012|2-Sided|95.0|-4.577|-1.167||P-value is from Mixed Model Repeated Measures (MMRM) with unstructured covariance matrix, adjusting for treatment, region, duration of illness, baseline DLQI score, visit, and an interaction terms for visit × baseline DLQI score and visit × treatment|Mixed Model Repeated Measures||||
1618264|NCT02383589|2971766|Superiority||Hazard Ratio (HR)|0.15|||<|0.0001|2-Sided|95.0|0.06|0.39||P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization|Log Rank||||
1618265|NCT02383589|2971767|Superiority||Hazard Ratio (HR)|4.83||||0.0003|2-Sided|95.0|1.97|11.81||P-value is from a stratified log-rank test used to test the time to first disease flare between the RTX and MMF treatment arms over the 52-week treatment period, adjusting for the stratification factors applied at randomization|Log Rank||||
1618266|NCT02383589|2971768|Superiority||Adjusted Rate Ratio|0.12|||<|0.0001|2-Sided|95.0|0.05|0.29||The model was adjusted for the following covariates in addition to log (each participant’s duration in study) as an offset: treatment, region, duration of illness, baseline PDAI activity score, and baseline prednisone dose.|Negative Binominal Regression||||
1618267|NCT02383589|2971769|Superiority|||||||0.0005|||||||Wilcoxon (Mann-Whitney)||||
1618268|NCT02383589|2971770|Superiority||Difference in proportion|30.8|||<|0.0001|2-Sided|95.0|14.7|45.15||The analysis was stratified by the stratification factors applied at randomization.|Cochran-Mantel-Haenszel||||
1618269|NCT02383420|2971782|Superiority or Other|||||||0||||||Level of significance (alpha) = 0.05|t-test, 1 sided||||
1618270|NCT02383420|2971783|Superiority or Other|||||||0.415||||||Level of significance (alpha) = 0.05|t-test, 2 sided||||
1618271|NCT02382744|2971811|Superiority or Other|||||||0.0057|||||||Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two arms, Patients with response to nerve stimulation and Patients with lack response to nerve stimulation, as far as the two categorical outcomes are concerned, block failure at 30 minutes post nerve block versus no block failure at 30 minutes post nerve block."|
1618272|NCT02382744|2971814|Superiority or Other||"Median survival ratio"|0.58||||0.02|2-Sided|95.0|0.37|0.93|||Log Rank||"Numerator, group Ultrasound Guidance; denominator, group, Ultrasound Guidance + Nerve Stimulation"||
1618274|NCT02382744|2971821|Superiority or Other||"Median survival ratio"|0.7||||0.12|2-Sided|95.0|0.38|1.31|||Log Rank||"Numerator, group Ultrasound Guidance; denominator, group, Ultrasound Guidance + Nerve Stimulation"|"To assess speed of onset, sensation to pinprick in the distribution of the saphenous nerve was assessed for each patient every 5 min until complete sensory loss was noted, or until 30 min had elapsed. To compare the two groups in speed of onset on the basis of these data, we constructed Kaplan-Meyer survival curves for the times to onset of sensory blockade and compared the underlying time-to-event data with the log-rank test."|
1618275|NCT02382744|2971822|Superiority or Other|||||||0.26||||||Two-sided P-value|Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two groups, Ultrasound Guidance and Ultrasound Guidance and Nerve Stimulation, as far as the two categorical outcomes are concerned, incomplete block at 30 minutes post nerve block versus no incomplete block at 30 minutes post nerve block."|
1618276|NCT02382744|2971823|Superiority or Other|||||||0.62|||||||Fisher Exact||||
1618277|NCT02382744|2971824|Superiority or Other|||||||0.62||||||Two-sided P-value|Fisher Exact|||"This contingency-table type analysis (Fisher Exact test) compares the two groups, Ultrasound Guidance and Ultrasound Guidance and Nerve Stimulation, as far as the two categorical outcomes are concerned, block failure at 30 minutes post nerve block versus no block failure at 30 minutes post nerve block."|
1618278|NCT02382744|2971825|Superiority or Other||Difference between proportions (%)|10.0||||0.25|2-Sided|95.0|-11.9|31.9||One-sided P-value based on the lack of plausibility that additional nerve stimulation would worsen sensory blockade rates.|Fisher Exact|||We sought to detect an increase in the rate of complete absence of sensation to pinprick 30 min following ultrasound-guided subsartorial saphenous nerve blockade to 90% from an assumed baseline of 64% as extrapolated from our previous study (cf. Head SJ et al. 2015) at β = 0.2. The required minimum sample size at α = 0.05 (one-sided) was 30 patients in each group. To be conservative, we aimed to enroll a total of 80 patients.|
1618279|NCT02382133|2971838|Superiority|comparing nasal and forehead oximetry sensor pressure ulcer incidence|||||=|0|||||||Chi-squared||||
1618280|NCT02382016|2971840|Superiority||Least squares (LS) mean difference|0.03||||0.9844|2-Sided|95.0|-2.85|2.91||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in SVO2 (LS mean difference macitentan 10 mg - placebo).||
1618281|NCT02382016|2971841|Superiority||Least squares (LS) mean difference|-171.48||||0.0001|2-Sided|95.0|-223.67|-119.3||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in TPR (LS mean difference macitentan 10 mg - placebo).||
1618282|NCT02382016|2971842|Superiority||Least squares (LS) mean difference|0.52||||0.0009|2-Sided|95.0|0.22|0.81||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in cardiac index (LS mean difference macitentan 10 mg - placebo).||
1618283|NCT02382016|2971843|Superiority||Least squares (LS) mean difference|-5.99||||0.0001|2-Sided|95.0|-8.4|-3.57||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in mPAP (LS mean difference macitentan 10 mg - placebo).||
1618284|NCT02382016|2971844|Superiority||Least squares (LS) mean difference|1.67||||0.0637|2-Sided|95.0|-0.1|3.44||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in mRAP (LS mean difference macitentan 10 mg - placebo).||
1618285|NCT02382016|2971845|Superiority||ratio of geometric means|0.874||||0.3951|2-Sided|95.0|0.639|1.196||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|ANCOVA||||
1618286|NCT02382016|2971846|Superiority||Odds Ratio (OR)|6.253||||0.1278|2-Sided|95.0|0.714|298.376||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|Regression, Logistic|||A logistic regression model (exact) adjusted for treatment, PAH-specific therapy at baseline, and region as covariates was used to analyze worsening in WHO FC.|
1618287|NCT02382016|2971847|Superiority||Least squares (LS) mean difference|9.73||||0.4264|2-Sided|95.0|-14.5|33.95||No adjustment was made for multiplicity for secondary endpoints, therefore all corresponding p-values provided are of an exploratory nature.|mixed-effect model repeated measure||The estimated value refers to a between-treatment analysis of change from baseline to Week 12 in 6MWD (LS mean difference macitentan 10 mg - placebo).|The main analysis on 6MWD was performed using a mixed-effect model repeated measure (MMRM) adjusted for treatment, visit, region, PAH-specific therapy at baseline, and treatment-by-visit interaction as factors, and baseline 6MWD and WHO functional class (FC) as covariates.|
1618288|NCT02382016|2971848|Superiority||ratio of geometric means|0.65||||0.0001|2-Sided|95.0|0.59|0.72|||ANCOVA|ANCOVA model adjusted by treatment, background PAH-specific therapy at baseline and region as factors & log-transformed PVR at baseline as a covariate||The null hypothesis (change of PVR at Week 12 as a ratio of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed ratio of PVR at Week 12 to baseline PVR.|
1618289|NCT02381015|2971865|Other||Beta|94.7|Standard Error of the Mean|2.93||0.33|2-Sided||||||ANOVA||||
1618290|NCT02381015|2971866|Other||Beta|93.5|Standard Error of the Mean|1.55||0.42|2-Sided||||||ANOVA|||The statistical analysis shows the relation between risk given and risk recall at the immediate post results assessment for the total number of participants.|
1618291|NCT02381015|2971867|Superiority or Other (legacy)|||||||0.49|||||||Kruskal-Wallis||||
1618292|NCT02381015|2971868|Superiority or Other (legacy)|||||||0.29|||||||Chi-squared||||
1618293|NCT02381015|2971869|Superiority or Other (legacy)|||||||0.35|||||||Chi-squared||||
1618294|NCT02381015|2971870|Superiority or Other (legacy)|||||||0.29|||||||Chi-squared||||
1618550|NCT02373098|2972515|Other|||||||1|||||||Wilcoxon (Mann-Whitney)|||IL6|
1618297|NCT02380742|2971887|Superiority or Other||Mean Difference (Final Values)|-1.811|Standard Error of the Mean|0.83||0.03|2-Sided||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain and patient age.|
1618298|NCT02380742|2971888|Superiority or Other||Mean Difference (Final Values)|-1.96|Standard Error of the Mean|0.87||0.03|2-Sided||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for investigator training and pessary type.|
1618299|NCT02380742|2971889|Superiority or Other||Mean Difference (Final Values)|2.87|Standard Error of the Mean|0.47||0.02|2-Sided||||||ANCOVA|||The null hypothesis was that patients' pain scores at removal were the same between the lidocaine and placebo groups after controlling for baseline pain.|
1618300|NCT02379091|2971999|Superiority or Other||LS Mean Difference|-0.92|Standard Error of the Mean|0.347||0.01|2-Sided|95.0|-1.61|-0.23||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.|Namilumab - Placebo||
1618301|NCT02379091|2971999|Superiority or Other||LS Mean|-0.6|Standard Error of the Mean|0.366||0.107|2-Sided|95.0|-1.32|0.13||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and subject as a random effect with an unstructured covariance structure.|Namilumab - Placebo||
1618302|NCT02379091|2971999|Superiority or Other||Least Squares (LS) Mean Difference|-0.61|Standard Error of the Mean|0.351||0.086|2-Sided|95.0|-1.31|0.09||MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value.|ANOVA|Baseline values were used as a covariate and participant as a random effect with an unstructured covariance structure.|Namilumab - Placebo||
1618303|NCT02379052|2972002|Superiority||Least Squares Mean Difference|0.33||||0.091|2-Sided|95.0|-0.053|0.72|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values ([seeds = 12345 & 54321 in the 2 steps respectively; number of imputations=50]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.||
1618304|NCT02379052|2972003|Superiority||Least Square Mean Difference|-1.6||||0.0006|2-Sided|95.0|-2.5|-0.68|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values ([seeds = 12345 & 54321 in the 2 steps respectively; number of imputations=50])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.||
1618305|NCT02379052|2972004|Superiority||Least Squares Mean Difference|-107.13|||<|0.0001|2-Sided|95.0|-141.215|-73.046|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values ([seeds = 12345 & 54321 in the 2 steps respectively; number of imputations=50])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.||
1618306|NCT02379052|2972005|Superiority||Percent Difference|35.0||||0.0044|2-Sided|95.0|5.69|58.34||P-values were derived by Fisher exact test|Clopper-Pearson Exact|CI = Confidence interval calculated using Exact method|Difference is Dupilumab minus Placebo||
1618307|NCT02379052|2972006|Superiority||Percent Difference|17.8||||0.1365|2-Sided|95.0|-11.54|43.55||P-values were derived by Fisher exact test|Clopper-Pearson Exact|CI = Confidence interval calculated using Exact method|Difference is Dupilumab minus Placebo||
1618308|NCT02379052|2972007|Superiority||Least Squares Mean Difference|-21.1||||0.0318|2-Sided|95.0|-40.42|-1.86|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values ([seeds = 12345 & 54321 in the 2 steps respectively; number of imputations=50]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.||
1618309|NCT02379052|2972008|Superiority||Least Squares Mean Difference|-33.65||||0.0608|2-Sided|95.0|-68.828|1.536|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values ([seeds = 12345 & 54321 in the 2 steps respectively; number of imputations=50])|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.||
1618310|NCT02379052|2972009|Superiority||Least Squares Mean Difference|-13.9||||0.0635|2-Sided|95.0|-28.54|0.78|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values ([seeds = 12345 & 54321 in the 2 steps respectively; number of imputations=50]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using ANCOVA model with baseline measurement and baseline SDI score as covariates and the treatment as fixed factor.||
1618311|NCT02379052|2972010|Superiority||Least Squares Mean Difference|-23.23||||0.085|2-Sided|95.0|-49.677|3.212|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values ([seeds = 12345 & 54321 in the 2 steps respectively; number of imputations=50]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.||
1618312|NCT02379052|2972011|Superiority||Percent Difference|26.6||||0.049|2-Sided|95.0|-3.04|51.05|||Clopper-Pearson Exact||Difference is Dupilumab minus Placebo. CI = Confidence interval calculated using Clopper-Pearson Exact method||
1618313|NCT02379052|2972012|Superiority||Percent Difference|26.6||||0.049|2-Sided|95.0|-3.04|51.05|||Clopper-Pearson Exact||Difference is Dupilumab minus Placebo. CI = Confidence interval calculated using Clopper-Pearson Exact method||
1618352|NCT02376790|2972296|Superiority||LS Mean Treatment Difference|0.16|Standard Error of the Mean|0.42||0.7|2-Sided|95.0|-0.66|0.98||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference||
1618551|NCT02373098|2972515|Other|||||||0.911|||||||Wilcoxon (Mann-Whitney)|||CXCL13|
1618314|NCT02379052|2972013|Superiority||Least Squares Mean Difference|-11.0||||0.4147|2-Sided|95.0|-37.46|15.467|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values ([seeds = 12345 & 54321 in the 2 steps respectively; number of imputations=50]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.||
1618315|NCT02379052|2972014|Superiority||Least Squares Mean Difference|-0.8||||0.383|2-Sided|95.0|-2.48|0.96|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values ([seeds = 12345 & 54321 in the 2 steps respectively; number of imputations=50]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.||
1618316|NCT02379052|2972015|Superiority||Least Squares Mean Difference|-26.45||||0.0312|2-Sided|95.0|-50.523|-2.387|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values ([seeds = 12345 & 54321 in the 2 steps respectively; number of imputations=50]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.||
1618317|NCT02379052|2972016|Superiority||Least Squares (LS) Mean Difference|-1.7||||0.0304|2-Sided|95.0|-3.22|-0.16|||ANCOVA|A 2-step multiple imputation (MI) method addressed missing values ([seeds = 12345 & 54321 in the 2 steps respectively; number of imputations=50]).|The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.||
1618318|NCT02378480|2972070|Non-Inferiority|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.8|||||2-Sided|95.0|-1.0|6.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.||
1618319|NCT02378480|2972071|Non-Inferiority|A non-inferiority margin of 10% was used for the analysis.|treatment difference|2.5|||||2-Sided|95.0|-3.2|8.2|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.||
1618320|NCT02378480|2972072|Non-Inferiority|A non-inferiority margin of 10% was used for the analysis.|treatment difference|-0.7|||||2-Sided|95.0|-6.3|4.9|||||The 95% confidence interval was constructed based on the Miettinen and Nurminen method without stratification. Treatment difference for a response of clinical success was calculated as omadacycline minus linezolid.||
1618321|NCT02378220|2972084|Other||Hazard Ratio (HR)|0.6||||0.09|2-Sided|95.0|0.33|1.1|||Log Rank||||
1618322|NCT02378220|2972085|Other||Hazard Ratio (HR)|0.59||||0.1|2-Sided|95.0|0.31|1.12|||Log Rank||||
1618323|NCT02378220|2972086|Other||Risk Ratio (RR)|0.58||||0.045|2-Sided|95.0|0.34|0.99|||Regression, Poisson||||
1618324|NCT02378220|2972086|Other||Risk Ratio (RR)|0.62||||0.16|2-Sided|95.0|0.31|1.21||P-Value for 30 days measure|Regression, Poisson||||
1618325|NCT02378220|2972087|Other||Risk Ratio (RR)|0.48||||0.007|2-Sided|95.0|0.27|0.82||P-Value for 60 days measure|Regression, Poisson||||
1618326|NCT02378220|2972087|Other||Risk Ratio (RR)|0.65||||0.21|2-Sided|95.0|0.32|1.28||P-value for 30 days measure.|Regression, Poisson||||
1618327|NCT02377921|2972112|Other||LS Mean Difference|-0.32||||0.5608|2-Sided|95.0|-1.39|0.75||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo||
1618328|NCT02377921|2972113|Superiority||LS Mean Difference|-1.4||||0.2241|2-Sided|95.0|-3.66|0.86||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER - placebo||
1618329|NCT02377921|2972114|Other||LS Mean Difference|-10.98||||0.1964|2-Sided|95.0|-27.64|5.68||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo||
1618330|NCT02377921|2972115|Superiority||LS Mean Difference|-0.43||||0.3907|2-Sided|95.0|-1.4|0.55||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo||
1618331|NCT02377921|2972116|Superiority||LS Mean Difference|-2.76||||0.1235|2-Sided|95.0|-6.27|0.75||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference: Ace-ER 6 g/day - placebo||
1618332|NCT02377921|2972117|Superiority||LS Mean Difference|-0.72||||0.2739|2-Sided|95.0|-2.01|0.57||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo||
1618333|NCT02377921|2972118|Superiority||LS Mean Difference|-1.49||||0.5023|2-Sided|95.0|-5.83|2.86||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo||
1618334|NCT02377921|2972119|Superiority||LS Mean Difference|-0.4||||0.6938|2-Sided|95.0|-2.38|1.58||GEE model includes change from Baseline as dependent variable, visit, treatment and visit by treatment as fixed factors, and Baseline values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo||
1618335|NCT02377921|2972120|Superiority||Least Squares (LS) Mean Difference|0.74||||0.5387|2-Sided|95.0|-1.61|3.09||Generalized estimating equation (GEE) model includes change from Baseline (BL) as dependent variable, visit, treatment and visit by treatment as fixed factors, and BL values, sex, and region as covariates, with compound symmetry covariance structure.|GEE model||Difference = Ace-ER - placebo||
1618336|NCT02377349|2972276|Superiority|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio [dTpa Group-Mother/Control Group-Mother] for anti-PRN antibodies was greater than or equal to (≥) 1.5.|GMC ratio|20.65|||||2-Sided|95.0|15.86|26.88||||||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.|
1618337|NCT02377349|2972276|Superiority|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio [dTpa Group-Mother/Control Group-Mother] for anti-FHA antibodies was greater than or equal to (≥) 1.5.|GMC ratio|16.11|||||2-Sided|95.0|13.48|19.24||||||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.|
1618338|NCT02377349|2972276|Superiority|Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio [dTpa Group-Mother/Control Group-Mother] for anti-PT antibodies was greater than or equal to (≥) 1.5.|GMC ratio|8.47|||||2-Sided|95.0|7.02|10.2||||||GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.|
1618339|NCT02377063|2972277|Other||Mean Difference (Final Values)|10.5||||0.026|2-Sided|||||p<0.05 was defined as significant|ANOVA|||Comparison was made to day 4 minus day 0 (baseline) change of phylum Bacteroidetes after juice consumption|
1618340|NCT02377063|2972277|Other||Mean Difference (Final Values)|-11.2||||0.014|2-Sided|||||p<0.05 was defined as significant|ANOVA|||Comparison was made to day 4 minus day 0 (baseline) change of phylum Firmicutes after juice consumption|
1618341|NCT02376790|2972287|Superiority||Treatment Difference|17.1||||0.012|2-Sided|95.0|4.0|30.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.|
1618342|NCT02376790|2972287|Superiority||Treatment Difference|20.1||||0.004|2-Sided|95.0|6.8|33.3||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.|
1618343|NCT02376790|2972288|Superiority||Treatment Difference|4.2||||0.4|2-Sided|95.0|-5.6|14.0||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.||
1618344|NCT02376790|2972288|Superiority||Treatment Difference|11.4||||0.019|2-Sided|95.0|2.0|20.8||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.||
1618345|NCT02376790|2972293|Superiority||LS Mean Treatment Difference|6.97|Standard Error of the Mean|4.5||0.12|2-Sided|95.0|-1.89|15.83||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.|
1618346|NCT02376790|2972293|Superiority||LS Mean Treatment Difference|15.95|Standard Error of the Mean|4.55|<|0.001|2-Sided|95.0|6.99|24.9||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.|
1618347|NCT02376790|2972294|Superiority||LS Mean Treatment Difference|3.02|Standard Error of the Mean|4.33||0.49|2-Sided|95.0|-5.49|11.54||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference||
1618348|NCT02376790|2972294|Superiority||LS Mean Treatment Difference|9.36|Standard Error of the Mean|4.33||0.031|2-Sided|95.0|0.85|17.87||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference||
1618349|NCT02376790|2972295|Superiority||Treatment Difference|8.8||||0.11|2-Sided|95.0|-1.9|19.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.||
1618350|NCT02376790|2972295|Superiority||Treatment Difference|3.2||||0.55|2-Sided|95.0|-7.3|13.7||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.||
1618351|NCT02376790|2972296|Superiority||LS Mean Treatment Difference|0.04|Standard Error of the Mean|0.42||0.93|2-Sided|95.0|-0.79|0.86||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference||
1618552|NCT02373098|2972515|Other|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||IL17A|
1618353|NCT02376790|2972297|Superiority||Treatment Difference|10.9||||0.12|2-Sided|95.0|-2.5|24.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.||
1618354|NCT02376790|2972297|Superiority||Treatment Difference|12.9||||0.057|2-Sided|95.0|-0.4|26.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.||
1618355|NCT02376790|2972298|Superiority||LS Mean Treatment Difference|6.34|Standard Error of the Mean|33.05||0.85|2-Sided|95.0|-58.75|71.42||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference||
1618356|NCT02376790|2972298|Superiority||LS Mean Treatment Difference|13.92|Standard Error of the Mean|33.23||0.68|2-Sided|95.0|-51.52|79.36||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference||
1618357|NCT02376790|2972300|Superiority||LS Mean Treatment Difference|-0.4|Standard Error of the Mean|0.24||0.1|2-Sided|95.0|-0.88|0.08||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference||
1618358|NCT02376790|2972300|Superiority||LS Mean Treatment Difference|-0.56|Standard Error of the Mean|0.24||0.02|2-Sided|95.0|-1.03|-0.09||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference||
1618359|NCT02376790|2972301|Superiority||LS Mean Treatment Difference|-0.5|Standard Error of the Mean|0.85||0.56|2-Sided|95.0|-2.16|1.16||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Mental Component Summary at week 24|
1618360|NCT02376790|2972301|Superiority||LS Mean Treatment Difference|-0.03|Standard Error of the Mean|0.84||0.97|2-Sided|95.0|-1.69|1.63||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Mental Component Summary at week 24|
1618361|NCT02376790|2972301|Superiority||LS Mean Treatment Difference|1.71|Standard Error of the Mean|0.8||0.033|2-Sided|95.0|0.13|3.28||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Physical Component Summary at week 24|
1618362|NCT02376790|2972301|Superiority||LS Mean Treatment Difference|1.94|Standard Error of the Mean|0.8||0.015|2-Sided|95.0|0.37|3.51||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in Physical Component Summary at week 24|
1618363|NCT02376790|2972302|Superiority||LS Mean Treatment Difference|-0.02|Standard Error of the Mean|0.05||0.67|2-Sided|95.0|-0.12|0.08||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference||
1618364|NCT02376790|2972302|Superiority||LS Mean Treatment Difference|-0.05|Standard Error of the Mean|0.05||0.34|2-Sided|95.0|-0.15|0.05||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference||
1618365|NCT02376790|2972303|Superiority||LS Mean Treatment Difference|-0.4|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|-0.62|-0.17||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in DAS28 at week 24|
1618366|NCT02376790|2972303|Superiority||LS Mean Treatment Difference|-0.29|Standard Error of the Mean|0.11|<|0.01|2-Sided|95.0|-0.52|-0.07||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in DAS28 at week 24|
1618367|NCT02376790|2972304|Superiority||LS Mean Treatment Difference|-1.72|Standard Error of the Mean|1.21||0.15|2-Sided|95.0|-4.09|0.65||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in SDAI at week 24|
1618368|NCT02376790|2972304|Superiority||LS Mean Treatment Difference|-0.98|Standard Error of the Mean|1.2||0.41|2-Sided|95.0|-3.35|1.38||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in SDAI at week 24|
1618369|NCT02376790|2972305|Superiority||LS Mean Treatment Difference|-1.32|Standard Error of the Mean|1.18||0.26|2-Sided|95.0|-3.63|0.99||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in CDAI at week 24|
1618370|NCT02376790|2972305|Superiority||LS Mean Treatment Difference|-0.63|Standard Error of the Mean|1.18||0.59|2-Sided|95.0|-2.93|1.68||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in CDAI at week 24|
1618418|NCT02374138|2972427|Superiority|||||||0.85||||||p-value adjusted for age and gender|Generalized Linear Model Analysis|||Parent use of mental health resources at 12 Months|
1618371|NCT02376790|2972306|Superiority||LS Mean Treatment Difference|-0.63|Standard Error of the Mean|0.15|<|0.001|2-Sided|95.0|-0.92|-0.34||P-value is unadjusted and considered descriptive|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in PASDAS at week 24|
1618372|NCT02376790|2972306|Superiority||LS Mean Treatment Difference|-0.62|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-0.91|-0.34||P-value is unadjusted and considered descriptive.|ANCOVA|ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use.|Methotrexate Monotherapy is the reference|Analysis of change from baseline in PASDAS at week 24|
1618373|NCT02376790|2972315|Superiority||Treatment Difference|13.7|||<|0.001|2-Sided|95.0|6.7|20.7||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR70 response at week 24.|
1618374|NCT02376790|2972315|Superiority||Treatment Difference|13.4|||<|0.001|2-Sided|95.0|6.5|20.4||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR70 response at week 24.|
1618375|NCT02376790|2972316|Superiority||Treatment Difference|11.8||||0.006|2-Sided|95.0|3.4|20.2||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR50 response at week 24.|
1618376|NCT02376790|2972316|Superiority||Treatment Difference|14.7|||<|0.001|2-Sided|95.0|6.4|23.0||P-value is unadjusted and considered descriptive.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|Analysis of the percentage of participants with an ACR50 response at week 24.|
1618377|NCT02376790|2972318|Superiority||Treatment Difference|11.6||||0.005|2-Sided|95.0|4.2|18.9||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The secondary hypothesis of this study was that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with PsA achieving MDA response at week 24.|
1618378|NCT02376790|2972318|Superiority||Treatment Difference|12.2||||0.005|2-Sided|95.0|4.9|19.6||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The secondary hypothesis of this study was that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with PsA achieving MDA response at week 24.|
1618379|NCT02376790|2972319|Superiority||Treatment Difference|9.2||||0.029|2-Sided|95.0|1.0|17.3||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The primary hypothesis of this study is that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with psoriatic arthritis achieving ACR 20 response at week 24.|
1618380|NCT02376790|2972319|Superiority||Treatment Difference|13.9||||0.005|2-Sided|95.0|5.8|22.0||Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors|The risk difference was estimated using the Mantel-Haenszel estimate of common risk difference using the stratification factors described above.|The primary hypothesis of this study is that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with psoriatic arthritis achieving ACR 20 response at week 24.|
1618381|NCT02376283|2972321|Other|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||<|0.0001||||||NSTEMI- clopi vs pras vs tic|ANOVA|ANOVA F(2,25) = 14.103||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student’s independent sample t-tests. Categorical variables were assessed using separate Fisher’s exact (Chi-square) test."|
1618395|NCT02374957|2972379|Superiority|||||||0.61|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over three months (two-sided test)."|
1618382|NCT02376283|2972321|Other|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||=|0||||||STEMI- clopidogrel vs prasugrel vs ticagrelor|ANOVA|ANOVA F(3,17) = 0.321||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student’s independent sample t-tests. Categorical variables were assessed using separate Fisher’s exact (Chi-square) test."|
1618383|NCT02376283|2972321|Other|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||"Continuous variables were expressed as mean ± SD and categorical variables as frequencies (%).~Continuous variables were analysed individually using student’s independent sample t-tests. Categorical variables were assessed using separate Fisher’s exact (Chi-square) test."|
1618384|NCT02376283|2972322|Other|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|ANOVA F(4,62)=18.932||NSTEMI- different drugs (as stated above)|
1618385|NCT02376283|2972322|Other|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||=|0|||||||ANOVA|ANOVA F(6,56)=1.707||STEMI- different drugs (as stated above)|
1618386|NCT02376283|2972322|Other|Comparison of means between groups was assessed using analysis of variance (ANOVA) technique. ANOVA allowed for a comparison of more than two means and enabled an assessment to be made of the relationship between, different drugs (clopidogrel active metabolite vs prasugrel active metabolite vs ticagrelor parent compound and active metabolite), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic, rows of STEMI vs NSTEMI/UA and different time points. P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||"Continuous variables were expressed as mean ± SEM (Standard Error of Measurement) and categorical variables as frequencies (%).~Continuous variables were analysed individually using student’s independent sample t-tests. Categorical variables were assessed using separate Fisher’s exact (Chi-square) test."|
1618387|NCT02376283|2972323|Other|Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001||||||Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|ANOVA F(2,40) = 29.097||NSTEMI- clopidogrel vs prasugrel vs ticagrelor|
1618388|NCT02376283|2972323|Other|Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.0001|||||||ANOVA|ANOVA F(3,36) = 12.282||STEMI- clop vs prasl vs tic|
1618389|NCT02376283|2972323|Other|A p value < 0.05 was considered to be statistically significant.Comparison of means between groups assessed using ANOVA allowing comparison of more than 2 means and enabled assessment made of the relationship between different drugs (clopidogrel vs prasugrel vs ticagrelor), different clinical states (STEMI vs NSTEMI/UA (Unstable angina)) and different time points.|||||<|0.05||||||Assessment made of relationship between groups-clop vs pras vs tic,rows of STEMI vs NSTEMI/UA and different time points.P-values reported are calculated values based on data collated during sample collection and review of clinical characteristics.|ANOVA|||Continuous variables expressed as mean ± SD (standard deviation) and categorical variables as frequencies (%).Continuous variables analysed individually using student’s independent sample t-tests. Categorical variables assessed using separate Fisher’s exact (Chi-square) test.|
1618390|NCT02375971|2972366|Superiority|The primary efficacy variable was treatment success, defined as the absence of active ROP and absence of unfavorable structural outcomes in both eyes 24 weeks after starting study treatment.|Odds Ratio (OR)|2.19||||0.0254|2-Sided|95.0|0.9932|4.8235|||Cochran-Mantel-Haenszel||||
1618391|NCT02375724|2972367|Superiority or Other||Least squares mean difference|-0.06||||0.844|2-Sided|95.0|-0.64|0.52|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors|||
1618392|NCT02375724|2972368|Superiority or Other||Least squares mean difference|-0.22||||0.0793|2-Sided|95.0|-0.46|0.03|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors|||
1618393|NCT02375724|2972369|Superiority or Other||Least squares mean difference|-1.02||||0.0306|2-Sided|95.0|-1.94|-0.1|||Mixed Models Analysis|Baseline and age as covariates; treatment group, sex, visit, smoking-status and treatment group-by-visit interaction as fixed effect factors|||
1618394|NCT02374957|2972378|Superiority|||||||0.26|||||||Log Rank|||"Null hypothesis: time to patency-failure (graft occlusion) is the same between treatment arms.~Alternate hypothesis: one arm differs from the other in durability of graft patency (two-sided test)."|
1618396|NCT02374957|2972380|Superiority|||||||0.82|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EACH Q sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EACH Q sum score than the other over initial six weeks (two-sided test)."|
1618397|NCT02374957|2972381|Superiority|||||||0.014|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over three months (two-sided test)."|
1618398|NCT02374957|2972382|Superiority|||||||0.027|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EQ5D visual analog score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D visual analog score than the other over initial six weeks (two-sided test)."|
1618399|NCT02374957|2972383|Superiority|||||||0.17|||||||t-test, 2 sided|||"Null hypothesis: three-month change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over three months (two-sided test)."|
1618400|NCT02374957|2972384|Superiority|||||||0.26|||||||t-test, 2 sided|||"Null hypothesis: six-week change in EQ5D sum score is the same between the two arms.~Alternate hypothesis: one arm experiences more change in EQ5D than the other over initial six weeks (two-sided test)."|
1618401|NCT02374463|2972389|Superiority||||||<|0.05|||||||ANOVA||||
1618402|NCT02374463|2972390|Superiority||||||=|0||||||not adjusted for multiple comparisons|ANOVA||||
1618403|NCT02374463|2972391|Superiority||||||=|0|||||||Chi-squared||||
1618404|NCT02374463|2972391|Superiority||||||=|0.84||||||Not adjusted for multiple comparisons|Chi-squared|exploratory aim prespecified.|||
1618405|NCT02374463|2972392|Superiority||||||=|0|||||||ANOVA|not adjusted for multiple comparisons|||
1618406|NCT02374463|2972393|Superiority||||||=|0||||||p value not adjusted for multiple comparisons|ANOVA||||
1618407|NCT02374463|2972394|Superiority||||||<|0.05||||||P value not adjusted for multiple comparisons|t-test, 2 sided|||within group change was assessed|
1618408|NCT02374346|2972400|Non-Inferiority or Equivalence|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student’s t test.Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|4.26||||0.001|2-Sided|95.0|1.82|9.95|||t-test, 2 sided|||Association of sevoflurane administration and postoperative headache|
1618409|NCT02374346|2972400|Non-Inferiority or Equivalence|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student’s t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.86||||0.041|2-Sided|95.0|1.06|14.06|||t-test, 2 sided|||Association of caffeine consumption and postoperative headache|
1618410|NCT02374346|2972400|Non-Inferiority or Equivalence|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student’s t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.79||||0.006|2-Sided|95.0|1.48|9.72|||t-test, 2 sided|||Association of intraoperative hypotension and postoperative headache|
1618411|NCT02374346|2972400|Non-Inferiority or Equivalence|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student’s t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|4.56||||0.005|2-Sided|95.0|1.58|13.17|||t-test, 2 sided|||Association of female gender and postoperative headache|
1618412|NCT02374346|2972400|Non-Inferiority or Equivalence|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student’s t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|1.85||||0.024|2-Sided|95.0|1.08|3.15|||t-test, 2 sided|||Female gender as a factor for developing postoperative headache|
1618413|NCT02374346|2972400|Non-Inferiority or Equivalence|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student’s t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|2.11||||0.008|2-Sided|95.0|1.22|3.66|||t-test, 2 sided|||Intraoperative hypotension associated with postoperative headache in total sample|
1618414|NCT02374346|2972400|Non-Inferiority or Equivalence|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student’s t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|1.85||||0.006|2-Sided|95.0|1.19|2.84|||t-test, 2 sided|||Smoking as a factor for developing postoperative headache|
1618415|NCT02374346|2972400|Non-Inferiority or Equivalence|Associations between categorical variables were tested by χ2 test, while differences between categorical and continuous variables were tested by Student’s t test. Univariate analysis was performed with the computation of unadjusted odds ratios with 95% confidence intervals. A stepwise multiple logistic regression analysis was conducted to find independent factors.|Odds Ratio (OR)|3.23||||0.001|2-Sided|95.0|2.04|5.13|||t-test, 2 sided|||Sevoflurane administration in developing postoperative headache|
1618416|NCT02374164|2972422|Superiority or Other||Point Estimate|0.72|||||2-Sided|90.0|0.612|0.847|||||Ratio Fed/Fasted. Point estimate and 90% CI were obtained from the exponentiated results of analysis of the natural logarithm–transformed data. Bioequivalence was reached if the value was 0.80 to 1.25.|Relative bioavailability of a single dose of Febuxostat XR 80 mg in the fasted and fed (high-fat meal) states.|
1618417|NCT02374138|2972426|Other|Univariate test||||||0.9|||||||Wilcoxon (Mann-Whitney)||||
1618419|NCT02374138|2972427|Superiority|||||||0.02||||||p-value adjusted for age and gender|Generalized Linear Model Analysis|||Parent use of mental health resources at 6 Months|
1618420|NCT02374138|2972428|Other|Univariate test||||||0.94|||||||Chi-squared||||
1618421|NCT02374138|2972429|Superiority|||||||0.98||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ETS Exposure at 12 Month Follow up|
1618422|NCT02374138|2972429|Superiority|||||||0.91||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ETS exposure at 6 Month Follow Up|
1618423|NCT02374138|2972430|Other|Univariate test||||||0.2|||||||Chi-squared|||Parent education|
1618424|NCT02374138|2972431|Superiority|Days of Quick Relief Medicine Use at 12 month follow up||||||0.58|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender|||
1618425|NCT02374138|2972431|Superiority|Days of Quick Relief Medicine Use at 6 month follow up||||||0.7|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender|||
1618426|NCT02374138|2972431|Superiority|Days of Activity Limitations at 12 month follow up||||||0.84|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender|||
1618427|NCT02374138|2972431|Superiority|Days of Activity Limitations at 6 month follow up||||||0.82|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender|||
1618428|NCT02374138|2972431|Superiority|Daytime Asthma Symptoms at 12 month follow up||||||0.11|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender|||
1618429|NCT02374138|2972431|Superiority|Daytime asthma symptoms in prior 14d at 6-month follow up||||||0.54|||||||Generalized Linear Model Analysis|By repeated measures, p-value adjusted for age and gender|||
1618430|NCT02374138|2972432|Superiority|By repeated measures, p-value adjusted for age and gender||||||0.35|||||||Generalized Linear Model Analysis||||
1618431|NCT02374138|2972434|Superiority|||||||0.62||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on LOT-R at 12 Month Follow Up|
1618432|NCT02374138|2972434|Superiority|||||||0.46||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on LOT-R at 6 Month Follow Up|
1618433|NCT02374138|2972436|Superiority|||||||0.58||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Score on Brief COPE at 12 Months|
1618434|NCT02374138|2972439|Superiority|||||||1|||||||Fisher Exact||||
1618435|NCT02374138|2972440|Superiority|||||||0.57||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Quality of Life at 12 Month Follow up|
1618436|NCT02374138|2972440|Superiority|||||||0.53||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||Quality of Life at 6 Month Follow up|
1618437|NCT02374138|2972441|Superiority|||||||0.77||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||12 Month Follow up|
1618438|NCT02374138|2972441|Superiority|||||||0.53||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||6 Month Follow Up|
1618439|NCT02374138|2972442|Superiority|||||||0.8||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 Month Follow Up|
1618440|NCT02374138|2972442|Superiority|||||||0.7||||||Repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month Follow Up|
1618441|NCT02374138|2972443|Superiority|||||||0.44||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 month follow up|
1618442|NCT02374138|2972443|Superiority|||||||0.32||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month follow up|
1618443|NCT02374138|2972444|Superiority|||||||0.06||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 Month Follow Up|
1618444|NCT02374138|2972444|Superiority|||||||0.32||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Month Follow Up|
1618445|NCT02374138|2972445|Superiority|||||||0.48||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||Courses of systemic steroids between 6m and 12m FU|
1618446|NCT02374138|2972445|Superiority|||||||0.98||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||Courses of systemic steroids over 6 months|
1618447|NCT02374138|2972446|Superiority|||||||0.44||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||ED Visits between 6 and 12 Month follow up|
1618448|NCT02374138|2972446|Superiority|||||||0.63||||||Adjusted for child age, gender, and baseline value|Generalized Linear Model Analysis|||ED visits over 6 months|
1618449|NCT02374138|2972447|Superiority|||||||0.62||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||LTRA use at 12 Month Follow Up|
1618450|NCT02374138|2972447|Superiority|||||||0.35||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||LTRA Use at 6 Months|
1618451|NCT02374138|2972447|Superiority|||||||0.34||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ICS Use at 12 Month Follow Up|
1618452|NCT02374138|2972447|Superiority|||||||0.35||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||ICS Use at 6 Month Follow Up|
1618453|NCT02374138|2972449|Superiority|||||||0.25||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 12 month follow up|
1618454|NCT02374138|2972449|Superiority|||||||0.87||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 month follow up|
1618455|NCT02374138|2972450|Superiority|||||||0.93||||||By repeated measures, p-value adjusted for age and gender|Generalized Linear Model Analysis|||At 6 Months|
1618456|NCT02374099|2972453|Superiority||Hazard Ratio (HR)|0.59|||=|0|2-Sided|95.0|0.23|1.53|||Log Rank||||Hazard Ratio and associated two-sided 95% CI were estimated by the Cox proportional hazard model.
1618545|NCT02373098|2972515|Other|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||CXCL10=IP-10 (CXCR3 ligand)|
1618546|NCT02373098|2972515|Other|||||||0.208|||||||Wilcoxon (Mann-Whitney)|||VLA4|
1618457|NCT02374099|2972454|Superiority||Difference in Clinical Benefit Rate|0.7|||=|0|2-Sided|95.0|-17.76|19.04|||Fisher Exact||||The two-sided 95% confidence interval for the difference in clinical benefit rate was estimated by the Wilson method.
1618458|NCT02374099|2972455|Superiority||Difference in Response Rates|6.3|||=|0|2-Sided|95.0|-2.47|15.06|||Fisher Exact||||The two-sided 95% confidence interval for the difference in ORR was estimated by the Wilson method.
1618459|NCT02374099|2972456|Superiority||Hazard Ratio (HR)|0.87|||=|0|2-Sided|95.0|0.54|1.42|||Log Rank||||Hazard ratio and associated two-sided 95% confidence intervals (CI) were estimated by the Cox proportional hazard models.
1618460|NCT02374060|2972457|Superiority||Hazard Ratio (HR)|0.64||||0.53|2-Sided|95.0|0.16|2.59|||Regression, Cox||Dexamthasone/Intravitreal||
1618461|NCT02374060|2972457|Superiority||Hazard Ratio (HR)|0.71||||0.65|2-Sided|95.0|0.16|3.11|||Regression, Cox||Dexamethasone/Periocular||
1618462|NCT02374060|2972457|Superiority||Hazard Ratio (HR)|1.07||||0.92|2-Sided|95.0|0.28|4.01|||Regression, Cox||Intravitreal/Periocular||
1618463|NCT02374060|2972458|Superiority||Hazard Ratio (HR)|1.32||||0.37|2-Sided|95.0|0.72|2.43|||Regression, Cox||Dexamethasone/intravitreal||
1618464|NCT02374060|2972458|Superiority||Hazard Ratio (HR)|2.52||||0.007|2-Sided|95.0|1.29|4.91|||Regression, Cox||Dexamethasone/periocular||
1618465|NCT02374060|2972458|Superiority||Hazard Ratio (HR)|1.83||||0.09|2-Sided|95.0|0.91|3.65|||Regression, Cox||Intravitreal/periocular||
1618466|NCT02374060|2972459|Superiority||Hazard Ratio (HR)|1.43||||0.3|2-Sided|95.0|0.72|2.81|||Regression, Cox||Dexamethasone/intravitreal||
1618467|NCT02374060|2972459|Superiority||Hazard Ratio (HR)|2.85||||0.009|2-Sided|95.0|1.3|6.28|||Regression, Cox||Dexamethasone/Intravitreal||
1618468|NCT02374060|2972459|Superiority||Hazard Ratio (HR)|1.92||||0.11|2-Sided|95.0|0.86|4.29|||Regression, Cox||Intravitreal/Periocular||
1618469|NCT02374060|2972460|Superiority||Hazard Ratio (HR)|1.45||||0.62|2-Sided|95.0|0.34|6.26|||Regression, Cox||Dexamethasone/Intravitreal||
1618470|NCT02374060|2972460|Superiority||Hazard Ratio (HR)|0.46||||0.2|2-Sided|95.0|0.14|1.5|||Regression, Cox||Dexamethasone/Periocular||
1618471|NCT02374060|2972460|Superiority||Hazard Ratio (HR)|0.33||||0.1|2-Sided|95.0|0.09|1.24|||Regression, Cox||Intravitreal/Periocular||
1618472|NCT02374060|2972464|Superiority||Difference in mean change from BL|-0.4||||0.84|2-Sided|95.0|-4.16|3.37|||mixed effects model||Dexamethasone-intravitreal||
1618473|NCT02374060|2972464|Superiority||Difference in mean change from BL|5.14||||0.019|2-Sided|95.0|0.84|9.44|||mixed effects model||Dexamethasone - periocular||
1618474|NCT02374060|2972464|Superiority||Difference in mean change from BL|5.53||||0.013|2-Sided|95.0|1.14|9.92|||mixed effects model||Intravitreal - periocular||
1618475|NCT02374060|2972465|Superiority||Difference in mean change from BL|-0.16||||0.93|2-Sided|95.0|-3.67|3.34|||mixed effects model||Dexamethasone - intravitreal||
1618476|NCT02374060|2972465|Superiority||Difference in mean change from BL|5.16||||0.004|2-Sided|95.0|1.6|8.72|||mixed effects model||Dexamethasone - periocular||
1618477|NCT02374060|2972465|Superiority||Difference in mean change from BL|5.32||||0.003|2-Sided|95.0|1.82|8.82|||mixed effects model||Intravitreal - periocular||
1618478|NCT02374060|2972466|Superiority||Difference in proportion|0.05||||0.54|2-Sided|95.0|-0.12|0.22|||mixed effects model||Dexamethasone - intravitreal||
1618479|NCT02374060|2972466|Superiority||Difference in proportion|0.06||||0.51|2-Sided|95.0|-0.11|0.23|||mixed effects model||Dexamethasone - periocular||
1618480|NCT02374060|2972466|Superiority||Difference in proportion|0.004||||0.96|2-Sided|95.0|-0.16|0.17|||mixed effects model||Intravitreal - periocular||
1618481|NCT02374060|2972467|Superiority||Difference in proportion|0.13||||0.12|2-Sided|95.0|-0.04|0.3|||mixed effects model||Dexamethasone - intravitreal||
1618482|NCT02374060|2972467|Superiority||Difference in proportion|0.4|||<|0.0001|2-Sided|95.0|0.25|0.56|||mixed effects model||Dexamethasone - periocular||
1618483|NCT02374060|2972467|Superiority||Difference in proportion|0.27|||<|0.0005|2-Sided|95.0|0.11|0.43|||mixed effects model||Intravitreal - periocular||
1618484|NCT02374060|2972468|Superiority||Difference in proportion|0.002||||0.98|2-Sided|95.0|-0.16|0.16|||mixed effects model||Dexamethasone - Intravitreal||
1618485|NCT02374060|2972468|Superiority||Difference in proportion|0.12||||0.11|2-Sided|95.0|-0.03|0.28|||mixed effects model||Dexamethasone - Periocular||
1618486|NCT02374060|2972468|Superiority||Difference in proportion|0.12||||0.1|2-Sided|95.0|-0.03|0.27|||mixed effects model||Intravitreal - Periocular||
1618487|NCT02374060|2972469|Superiority||Difference in proportion|0.05||||0.45|2-Sided|95.0|-0.09|0.19|||mixed effects model||Dexamethasone - intravitreal||
1618488|NCT02374060|2972469|Superiority||Difference in proportion|0.44|||<|0.0001|2-Sided|95.0|0.29|0.59|||mixed effects model||Dexamethasone - periocular||
1618489|NCT02374060|2972469|Superiority||Difference in proportion|0.39|||<|0.0001|2-Sided|95.0|0.24|0.53|||mixed effects model||Intravitreal - periocular||
1618490|NCT02374060|2972470|Non-Inferiority|The non inferiority margin was 1.16|Ratio of the proportion of BL|0.94|||||2-Sided|99.87|0.77|1.16|||||A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal||
1618491|NCT02374060|2972470|Superiority||Ratio of the proportion of BL|0.89||||0.07|2-Sided|99.87|0.72|1.1||the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||ratio of dexamethasone over periocular||
1618492|NCT02374060|2972470|Superiority||Ratio of the proportion of BL|0.95||||0.35|2-Sided|99.87|0.77|1.16||Two sided type I error threshold was 0.00132 since recruitment was halted after the single Two sided type I error threshold was 0.00132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||Ratio of intravitreal over periocular||
1618493|NCT02374060|2972471|Non-Inferiority|The non inferiority margin was 1.16|Ratio of the proportion of BL|0.88|||||2-Sided|99.87|0.71|1.08|||||A mixed effects model was used to create the confidence interval for testing non-inferiority. The direction is the ratio of dexamethasone over intravitreal||
1618547|NCT02373098|2972515|Other|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||IL23|
1618494|NCT02374060|2972471|Superiority||Ratio of the proportion of BL|0.69|||<|0.0001|2-Sided|99.87|0.56|0.86||the 2 sided type 1 error threshold was 0.000132 since recruitment was halted after the single preplanned interim analysis|mixed effects model||ratio of dexamethasone over periocular||
1618495|NCT02374060|2972471|Superiority||Ratio of the proportion of BL|0.79|||<|0.0001|2-Sided|99.87|0.65|0.96||Two sided type I error threshold was 0.00132 since recruitment was halted after the single pre-planned interim analysis|mixed effects model||Ratio of intravitreal over periocular||
1618496|NCT02373371|2972477|Superiority|||||||0.0001|||||||Wilcoxon (Mann-Whitney)||||
1618497|NCT02373371|2972478|Superiority|||||||0.0005|||||||Wilcoxon (Mann-Whitney)||||
1618498|NCT02373371|2972480|Superiority|||||||0.846|||||||Wilcoxon (Mann-Whitney)|||"Main analysis:~nbDPKAdispM3 the number of KA disappeared at M3 after treatment with DPDT compared to the inclusion layer,~nbCPKAdispM3 the number of KA disappeared at M3 after treatment with conventional blue light,~The primary endpoint is:~differenceM3 = nbDPKAdispM3 - nbCPKAdispM3 The main analysis will consist of a signed Wilcoxon rank test for matched data testing whether difference M3 is significantly different from 0"|
1618499|NCT02373137|2972498|Superiority|||||||0.7|||||||t-test, 2 sided||||
1618500|NCT02373137|2972504|Superiority||Coefficient|-215.0||||0.051|2-Sided|95.0|-430.0|-0.4|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 12 months.||
1618501|NCT02373137|2972504|Superiority||Coefficient|-150.0||||0.17|2-Sided|95.0|-356.0|66.0|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 6 months.||
1618502|NCT02373137|2972504|Superiority||Coefficient|-77.0||||0.53|2-Sided|95.0|-326.0|172.0|||t-test, 2 sided||Comparing DMEK to UT-DSAEK at 3 months.||
1618503|NCT02373137|2972506|Superiority||Coefficient|-1.4|||<|0.001|2-Sided|95.0|-2.2|-0.7|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.4 lines better vision at 12 months.|Comparison of 12 Month Visual Acuity Between Groups|
1618504|NCT02373137|2972506|Superiority||Coefficient|-1.5|||<|0.002|2-Sided|95.0|-2.5|-0.6|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.5 lines better vision at 3 months.|Comparison of 3-Month Visual Acuity Between Groups|
1618505|NCT02373137|2972507|Superiority||Coefficient|-1.8|||<|0.001|2-Sided|95.0|-2.8|-1.0|||Regression, Linear|Multiple linear regression model with a covariate for baseline visual acuity.|Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.8 lines better vision at 6 months.||
1618506|NCT02373098|2972511|Other|||||||0.127|||||||Wilcoxon (Mann-Whitney)|||IL9+ (in CD4+CD25+)|
1618507|NCT02373098|2972511|Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||TNFa+ (in CD4+CD25+)|
1618508|NCT02373098|2972511|Other|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||CD8+IL9+ (in CD8+)|
1618509|NCT02373098|2972511|Other|||||||0|||||||Wilcoxon (Mann-Whitney)|||CD8+TNFa+ (in CD8+)|
1618510|NCT02373098|2972511|Other|||||||0.107|||||||Wilcoxon (Mann-Whitney)|||CD4+IL9+ (in CD4+)|
1618511|NCT02373098|2972511|Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||CD4+TNFa+ (in CD4+)|
1618512|NCT02373098|2972511|Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||IL4+ (in CD4+CD25+)|
1618513|NCT02373098|2972511|Other|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||IL10+ (in CD4+CD25+)|
1618514|NCT02373098|2972511|Other|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD8+IL4+ (in CD8+)|
1618515|NCT02373098|2972511|Other|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD8+IL10+ (in CD8+)|
1618516|NCT02373098|2972511|Other|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||CD4-CD8-IL4+ (in CD4-CD8-)|
1618517|NCT02373098|2972511|Other|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||CD4+IL4+ (in CD4+)|
1618518|NCT02373098|2972511|Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||CD4+IL10+ (in CD4+)|
1618519|NCT02373098|2972511|Other|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||IL17+ (in CD4+CD25+)|
1618520|NCT02373098|2972511|Other|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||IFNg+ (in CD4+CD25+)|
1618521|NCT02373098|2972511|Other|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD8+IL17+ (in CD8+)|
1618522|NCT02373098|2972511|Other|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD8+IFNg+ (in CD8+)|
1618523|NCT02373098|2972511|Other|||||||0.402|||||||Wilcoxon (Mann-Whitney)|||CD4+IL17+ (in CD4+)|
1618524|NCT02373098|2972511|Other|||||||0.069|||||||Wilcoxon (Mann-Whitney)|||CD4+IFNg+ (in CD4+)|
1618525|NCT02373098|2972511|Other|||||||0.209|||||||Wilcoxon (Mann-Whitney)|||CD3CD8|
1618526|NCT02373098|2972511|Other|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||CD3CD4|
1618527|NCT02373098|2972511|Other|||||||0.787|||||||Wilcoxon (Mann-Whitney)|||CD3CD8|
1618528|NCT02373098|2972511|Other|||||||0.356|||||||Wilcoxon (Mann-Whitney)|||CD3CD4|
1618529|NCT02373098|2972511|Other|||||||0.449|||||||Wilcoxon (Mann-Whitney)|||Hi CD16CD56 %|
1618530|NCT02373098|2972511|Other|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||NKT %|
1618531|NCT02373098|2972511|Other|||||||0.657|||||||Wilcoxon (Mann-Whitney)|||NK %|
1618532|NCT02373098|2972511|Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||CD19 %|
1618533|NCT02373098|2972511|Other|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||CD3 %|
1618534|NCT02373098|2972514|Other|||||||0.283|||||||Wilcoxon (Mann-Whitney)|||Hi CD4CD25|
1618535|NCT02373098|2972514|Other|||||||0.902|||||||Wilcoxon (Mann-Whitney)|||CD4CD25|
1618536|NCT02373098|2972514|Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Hi CD16CD56 abs|
1618537|NCT02373098|2972514|Other|||||||0.096|||||||Wilcoxon (Mann-Whitney)|||NKT abs|
1618538|NCT02373098|2972514|Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||NK abs|
1618539|NCT02373098|2972514|Other|||||||0.587|||||||Wilcoxon (Mann-Whitney)|||CD19 abs|
1618540|NCT02373098|2972514|Other|||||||0.256|||||||Wilcoxon (Mann-Whitney)|||CD3 abs|
1618541|NCT02373098|2972515|Other|||||||0.662|||||||Wilcoxon (Mann-Whitney)|||IL22|
1618542|NCT02373098|2972515|Other|||||||0.724|||||||Wilcoxon (Mann-Whitney)|||TNF alpha|
1618543|NCT02373098|2972515|Other|||||||0.057|||||||Wilcoxon (Mann-Whitney)|||IL4|
1618544|NCT02373098|2972515|Other|||||||0.725|||||||Wilcoxon (Mann-Whitney)|||CCL2=MCP-1|
1618553|NCT02373098|2972515|Other|||||||0|||||||Wilcoxon (Mann-Whitney)|||CCL5=RANTES|
1618554|NCT02372799|2972516|Superiority||LSMD|-0.2||||0.2158|2-Sided|95.0|-0.52|0.12|||MMRM||||
1618555|NCT02372799|2972516|Superiority||LSMD|-0.04||||0.7387|2-Sided|95.0|-0.31|0.22|||MMRM||||
1618556|NCT02372799|2972517|Superiority||LSMD|-2.39||||0.1433|2-Sided|95.0|-5.6|0.81|||MMRM||||
1618557|NCT02372799|2972517|Superiority||LSMD|-0.4||||0.7662|2-Sided|95.0|-3.08|2.27|||MMRM||||
1618558|NCT02372344|2972521|Superiority or Other||Geometric LS mean ratio|0.86|||||2-Sided|95.0|0.72|1.02||||||Total DHA: Ratio of Before meal to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.|
1618559|NCT02372344|2972521|Superiority or Other||Geometric LS mean ratio|0.87|||||2-Sided|95.0|0.73|1.04||||||Total DHA: Ratio of Fasting to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.|
1618560|NCT02372344|2972521|Superiority or Other||Geometric LS mean ratio|0.55||||||95.0|0.44|0.69||||||Total EPA: Ratio of Before Meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.|
1618561|NCT02372344|2972521|Superiority or Other||Geometric LS mean ratio|0.56|||||2-Sided|95.0|0.45|0.69||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC0-72) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.|
1618562|NCT02372344|2972522|Superiority or Other||Geometric LS mean ratio|0.57|||||2-Sided|95.0|0.45|0.71||||||Total DHA: Ratio of Before meal to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.|
1618563|NCT02372344|2972522|Superiority or Other||Geometric LS mean ratio|0.46|||||2-Sided|95.0|0.36|0.57||||||Total DHA: Ratio of Fasting to After meal. Primary comparisons for total DHA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.|
1618564|NCT02372344|2972522|Superiority or Other||Geometric LS mean ratio|0.44|||||2-Sided|95.0|0.33|0.59||||||Total EPA: Ratio of Before meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.|
1618565|NCT02372344|2972522|Superiority or Other||Geometric LS mean ratio|0.35|||||2-Sided|95.0|0.27|0.47||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (Cmax) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.|
1618566|NCT02372344|2972523|Superiority or Other||Geometric LS mean ratio|0.71|||||2-Sided|95.0|0.59|0.86||||||Total EPA: Ratio of Before meal to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.|
1618567|NCT02372344|2972523|Superiority or Other||Geometric least square (LS) mean ratio|0.64|||||2-Sided|95.0|0.54|0.77||||||Total EPA: Ratio of Fasting to After meal. Primary comparisons for total EPA were based on a linear mixed-effect model. This model included log-transformed PK parameter (AUC) as a response variable and treatment, sequence and period as fixed categorical effects, and subject nested within sequence as a random categorical effect.|
1618568|NCT02372097|2972536|Superiority or Other||LS mean difference|0.1099|||||2-Sided|90.0|0.0235|0.1963||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the λz as a dependent variable, and product, group and period as fixed effects.|
1618569|NCT02372097|2972537|Superiority or Other||LS mean difference|-0.0168|||||2-Sided|90.0|-0.0504|0.0169||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the MRT as a dependent variable, and product, group and period as fixed effects.|
1618570|NCT02372097|2972538|Superiority or Other||LS mean difference|0.375|||||2-Sided|90.0|-0.1452|0.8952||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with Tmax as a dependent variable, and product, group and period as fixed effects.|
1618571|NCT02372097|2972539|Superiority or Other||LS mean difference|-0.021||||||90.0|-0.0362|-0.0058||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the AUC(0-inf) as a dependent variable, and product, group and period as fixed effects.|
1618572|NCT02372097|2972540|Non-Inferiority or Equivalence|Two tablets of SYR-472 25 mg and 1 tablet of SYR-472 50 mg were considered bioequivalent if 90% CI of the mean differences of natural log-transformed Cmax of SYR-472Z was within the range of ln(0.80) to ln(1.25) or within the range of ln(0.9) to ln(1.11) and the results of dissolution test satisfied the requirement.|LS mean difference|-0.1292|||||2-Sided|90.0|-0.2177|-0.0406||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the Cmax as a dependent variable, and product, group and period as fixed effects.|
1618641|NCT02371759|2972572|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1618642|NCT02371759|2972588|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1618573|NCT02372097|2972541|Non-Inferiority or Equivalence|Two tablets of SYR-472 25 mg and 1 tablet of SYR-472 50 mg were considered bioequivalent if 90% CI of the mean differences of natural log-transformed AUC(0-168) of SYR-472Z was within the range of ln(0.80) to ln(1.25) or within the range of ln(0.9) to ln(1.11) and the results of dissolution test satisfied the requirement.|Least square (LS) mean difference|-0.017|||||2-Sided|90.0|-0.0344|0.0004||||||The 2-sided 90% confidence interval for the difference between the products (2 tablets of SYR-472 25 mg, 1 tablet of SYR-472 50 mg) was determined from the ANOVA model with the natural logarithms of the AUC(0-168) as a dependent variable, and product, group and period as fixed effects.|
1618574|NCT02371980|2972544|Superiority||Hazard Ratio (HR)|0.484||||0.002|2-Sided|95.0|0.304|0.771||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 20 mg Vs Double-blind Placebo|
1618575|NCT02371980|2972544|Superiority||Hazard Ratio (HR)|0.455|||<|0.001|2-Sided|95.0|0.286|0.725||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 10 mg Vs Double-blind Placebo|
1618576|NCT02371980|2972544|Superiority||Hazard Ratio (HR)|0.481|||<|0.002|2-Sided|95.0|0.302|0.766||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 5mg Vs Double-blind Placebo|
1618577|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.37|Standard Error of the Mean|0.141||0.009|2-Sided|95.0|-0.65|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32|
1618578|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.33|Standard Error of the Mean|0.139||0.018|2-Sided|95.0|-0.6|-0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32|
1618579|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.18|Standard Error of the Mean|0.141||0.209|2-Sided|95.0|-0.45|0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32|
1618580|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.11|Standard Error of the Mean|0.131||0.391|2-Sided|95.0|-0.37|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28|
1618581|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.15|Standard Error of the Mean|0.129||0.251|2-Sided|95.0|-0.4|0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28|
1618582|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.12|Standard Error of the Mean|0.131||0.362|2-Sided|95.0|-0.38|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28|
1618583|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.23|Standard Error of the Mean|0.135||0.087|2-Sided|95.0|-0.5|0.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24|
1618584|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.37|Standard Error of the Mean|0.133||0.006|2-Sided|95.0|-0.63|-0.1|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24|
1618585|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.16|Standard Error of the Mean|0.135||0.248|2-Sided|95.0|-0.42|0.11|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24|
1618586|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.33|Standard Error of the Mean|0.122||0.008|2-Sided|95.0|-0.57|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20|
1618587|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.44|Standard Error of the Mean|0.121|<|0.001|2-Sided|95.0|-0.67|-0.2|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20|
1618588|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.2|Standard Error of the Mean|0.121|<|0.092|2-Sided|95.0|-0.44|0.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20|
1618589|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.28|Standard Error of the Mean|0.124|<|0.023|2-Sided|95.0|-0.53|-0.04|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16|
1618590|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.37|Standard Error of the Mean|0.122|<|0.002|2-Sided|95.0|-0.61|-0.13|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16|
1618591|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.12|Standard Error of the Mean|0.123|<|0.333|2-Sided|95.0|-0.36|0.12|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16|
1618592|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.39|Standard Error of the Mean|0.124|<|0.002|2-Sided|95.0|-0.63|-0.15|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12|
1618593|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.5|Standard Error of the Mean|0.122|<|0.001|2-Sided|95.0|-0.74|-0.26|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12|
1618594|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.27|Standard Error of the Mean|0.122|<|0.025|2-Sided|95.0|-0.51|-0.03|||Least Squares Mean Difference|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12|
1618595|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.38|Standard Error of the Mean|0.123|<|0.002|2-Sided|95.0|-0.62|-0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8|
1618596|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.39|Standard Error of the Mean|0.121|<|0.001|2-Sided|95.0|-0.63|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8|
1618597|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.3|Standard Error of the Mean|0.121|<|0.014|2-Sided|95.0|-0.54|-0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8|
1618598|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.36|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.55|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4|
1618599|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.31|Standard Error of the Mean|0.099|<|0.002|2-Sided|95.0|-0.5|-0.12|||Least Squares Mean Difference|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4|
1618600|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.28|Standard Error of the Mean|0.099|<|0.004|2-Sided|95.0|-0.48|-0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4|
1618601|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.08|Standard Error of the Mean|0.085|<|0.361|2-Sided|95.0|-0.24|0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2|
1618602|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.09|Standard Error of the Mean|0.085|<|0.273|2-Sided|95.0|-0.26|0.07|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2|
1618603|NCT02371980|2972546|Superiority||Least Squares Mean Difference|-0.03|Standard Error of the Mean|0.085|<|0.732|2-Sided|95.0|-0.2|0.14|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2|
1618604|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-3.58|Standard Error of the Mean|1.143||0.002|2-Sided|95.0|-5.82|-1.34|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32|
1618605|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-3.97|Standard Error of the Mean|1.122|<|0.001|2-Sided|95.0|-6.16|-1.77|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32|
1618606|NCT02371980|2972547|Superiority||MMRM Model|-3.09|Standard Error of the Mean|1.136|<|0.007|2-Sided|95.0|-5.31|-0.86|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 32|
1618607|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-1.88|Standard Error of the Mean|1.015|<|0.065|2-Sided|95.0|-3.87|0.12|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28|
1618608|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-2.36|Standard Error of the Mean|0.997|<|0.018|2-Sided|95.0|-4.31|-0.4|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28|
1618609|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-1.9|Standard Error of the Mean|1.012|<|0.061|2-Sided|95.0|-3.88|0.09|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 28|
1618610|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-2.53|Standard Error of the Mean|1.011|<|0.012|2-Sided|95.0|-4.51|-0.55|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24|
1618611|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-3.5|Standard Error of the Mean|0.997|<|0.001|2-Sided|95.0|-5.46|-1.55|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24|
1618612|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-1.92|Standard Error of the Mean|1.008|<|0.057|2-Sided|95.0|-3.89|0.06|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 24|
1618613|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-2.76|Standard Error of the Mean|0.921|<|0.003|2-Sided|95.0|-4.57|-0.96|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20|
1618614|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-4.09|Standard Error of the Mean|0.906|<|0.001|2-Sided|95.0|-5.86|-2.31|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20|
1618615|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-2.61|Standard Error of the Mean|0.912|<|0.004|2-Sided|95.0|-4.4|-0.82|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 20|
1618616|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-2.63|Standard Error of the Mean|0.967|<|0.007|2-Sided|95.0|-4.52|-0.73|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16|
1618617|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-3.69|Standard Error of the Mean|0.952|<|0.001|2-Sided|95.0|-5.55|-1.82|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16|
1618618|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-2.04|Standard Error of the Mean|0.957|<|0.033|2-Sided|95.0|-3.92|-0.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 16|
1618619|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-3.64|Standard Error of the Mean|0.949|<|0.001|2-Sided|95.0|-5.5|-1.78|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12|
1618620|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-4.51|Standard Error of the Mean|0.934|<|0.001|2-Sided|95.0|-6.34|-2.68|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12|
1618621|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-2.92|Standard Error of the Mean|0.938|<|0.002|2-Sided|95.0|-4.76|-1.08|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 12|
1618622|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-3.0|Standard Error of the Mean|0.939|<|0.001|2-Sided|95.0|-4.84|-1.16|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8|
1618623|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-3.84|Standard Error of the Mean|0.919|<|0.001|2-Sided|95.0|-5.64|-2.03|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8|
1618624|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-2.95|Standard Error of the Mean|0.924|<|0.001|2-Sided|95.0|-4.76|-1.13|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 8|
1618625|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-2.5|Standard Error of the Mean|0.775|<|0.001|2-Sided|95.0|-4.02|-0.98|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4|
1618626|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-3.0|Standard Error of the Mean|0.761|<|0.001|2-Sided|95.0|-4.49|-1.51|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4|
1618627|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-2.43|Standard Error of the Mean|0.765|<|0.002|2-Sided|95.0|-3.93|-0.93|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 4|
1618628|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-0.41|Standard Error of the Mean|0.592|<|0.488|2-Sided|95.0|-1.57|0.75|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2|
1618629|NCT02371980|2972547|Superiority||Least Squares Mean Difference|-1.23|Standard Error of the Mean|0.589|<|0.037|2-Sided|95.0|-2.39|-0.08|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2|
1618630|NCT02371980|2972547|Superiority||Least Squares Mean (LSM) Difference|-0.48|Standard Error of the Mean|0.59|<|0.421|2-Sided|95.0|-1.63|0.68|||MMRM|MMRM with treatment, visit, BL II score, treatment by visit interaction as fixed factors, center as random effect, and unstructured covariance matrix.||Change From Baseline II at Week 2|
1618631|NCT02371980|2972548|Superiority||Hazard Ratio (HR)|0.483||||0.003|2-Sided|95.0|0.298|0.782||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 20 mg Vs Double-blind Placebo|
1618632|NCT02371980|2972548|Superiority||Hazard Ratio (HR)|0.476||||0.002|2-Sided|95.0|0.296|0.767||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 10 mg Vs Double-blind Placebo|
1618633|NCT02371980|2972548|Superiority||Hazard Ratio (HR)|0.517||||0.006|2-Sided|95.0|0.323|0.828||Gate-keeping fixed-sequence testing procedure was used for multiple comparisons.|Cox Proportional Hazards Model|Cox proportional hazards model with a factor for treatment and baseline II MADRS total score as a covariate, using the exact method to handle ties.||Double-blind Vortioxetine 5mg Vs Double-blind Placebo|
1618634|NCT02371759|2972565|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1618635|NCT02371759|2972566|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1618636|NCT02371759|2972567|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1618637|NCT02371759|2972568|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1618638|NCT02371759|2972569|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1618639|NCT02371759|2972570|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1618640|NCT02371759|2972571|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1618643|NCT02371759|2972589|Non-Inferiority or Equivalence|In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group|||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||In order to detect 20% difference in intraoral anesthesia duration between healthy and diabetic participants, with 80 % statistical power at a two-tailed significance level of 0.05 using Mann Whitney U test, it was calculated that at least 24 participants must be included in each group|
1618644|NCT02371746|2972590|Superiority||Change from baseline|30.4|Standard Deviation|1.84|<|0.001|2-Sided|95.0|-1.8|36.6|||ANCOVA|||estimatCohort 1 all Groups: Non-study eye: TRAVANTAN Z Cohort 1 - Group 1: Study Eye: 28.2 ug travoprost Cohort 1 - Group 2: Study Eye: 42.3 ug travoprost Cohort 1 - Group 3: Study Eye: 42 .5 ug travoprost Cohort 1 - Group 4: Study Eye: 85.0 ug travoprost|
1618645|NCT02371668|2972591|Superiority|||||||0.646|||||||Fisher Exact||||
1618646|NCT02371668|2972592|Superiority|||||||0.23|||||||Wilcoxon (Mann-Whitney)||||
1618647|NCT02371668|2972593|Superiority|||||||0.045|||||||Fisher Exact||||
1618648|NCT02371668|2972594|Superiority|||||||0.2445|||||||Wilcoxon (Mann-Whitney)||||
1618649|NCT02371668|2972595|Superiority|||||||0.137|||||||Fisher Exact||||
1618650|NCT02371668|2972596|Superiority|||||||0.1412|||||||Wilcoxon (Mann-Whitney)||||
1618651|NCT02371668|2972597|Superiority|||||||0.4989|||||||Wilcoxon (Mann-Whitney)||||
1618652|NCT02371668|2972598|Superiority|||||||0.114|||||||Fisher Exact||||
1618653|NCT02371668|2972599|Superiority|||||||0.31|||||||Wilcoxon (Mann-Whitney)||||
1618654|NCT02371629|2972614|Superiority or Other||Mean Difference (Net)|0.033|Standard Error of the Mean|0.0169||0.051|2-Sided|95.0|0.0|0.066|||Mixed model for repeated measure (MMRM)||||
1618655|NCT02371616|2972618|Non-Inferiority|Inferences: upper end of the 2-sided 95% CI for the treatment difference for the estimated effect of Test relative to Comparator, for success, should be <=6mm. (i.e., Test is no more than 6mm inferior to Comparator).|Least square (LS) mean difference|2.67||||0.2678|2-Sided|95.0|-2.06|7.4||From ANCOVA model: change from baseline as the response variable, treatment group, baseline Schiff stratum and study site as fixed effects, with baseline VAS score as covariate.|ANCOVA||Difference is first named treatment minus second named dentifrice such that a negative difference favors the first named treatment.|Statistical analysis applies to change from baseline at week 8 for test and comparator dentifrice.|
1618656|NCT02371369|2972630|Other|Treatment comparison analysis|||||<|0.0001|||||||Mixed effects model for repeated measure|||Treatment comparison between the pexidartinib and placebo groups at Week 25|
1618657|NCT02371369|2972631|Other|Treatment comparison analysis||||||0.0019|||||||Mixed effects model for repeated measure|||Treatment comparison between pexidartinib and placebo groups at Week 25|
1618658|NCT02371369|2972632|Other|Treatment comparison analysis|||||<|0.0001|||||||Mixed effects model for repeated measure|||Treatment comparison between the pexidartinib and placebo groups at Week 25|
1618659|NCT02371369|2972633|Other|Treatment comparison analysis||||||0.0043|||||||Mixed effects model for repeated measure|||Treatment comparison between the pexidartinib and placebo groups at Week 25|
1618660|NCT02371369|2972634|Other|Treatment comparison analysis|||||<|0.0001|||||||Mixed effects model for repeated measure|||Treatment comparison between the pexidartinib and placebo groups at Week 25|
1618661|NCT02370914|2972642|Other|||||||||||||||||This is a pilot study to evaluate the potential for utilizing cranial accelerometry to be used as an aid to diagnosis of concussion. No pre-specific statistical analysis was setup for this study.|This pilot study evaluated the ability of utilizing the Nautilus Neurowave data to be potentially used as an aid to diagnosis of concussion. The primary measures were evaluated using a 95% confidence interval for sensitivity and specificity. No comparison to any gold standards were made as part of this study.
1618662|NCT02370641|2972664|Other||Mean Difference (Final Values)|2.6||||0.009|2-Sided|||||p<0.05 was defined as significant|Wilcoxon (Mann-Whitney)|||Comparison was made to week 4 minus baseline change of phylum Proteobacteria abundance between urolithin excretors and non excretors|
1618663|NCT02370641|2972664|Other||Mean Difference (Final Values)|-4.0||||0.012|2-Sided|||||p<0.05 is defined as significant|Wilcoxon (Mann-Whitney)|||Comparison was made to week 4 minus baseline change of phylum Firmicutes abundance between urolithin excretors and non excretors|
1618664|NCT02370615|2972671|Superiority or Other||Geometric Mean Ratio (Day 7/Day 1)|1.061|||||2-Sided|90.0|0.986|1.143||||||Analysis for 1’Hydroxymidazolam|
1618665|NCT02370615|2972671|Superiority or Other||Geometric Mean Ratio (Day 7/Day 1)|1.425|||||2-Sided|90.0|1.291|1.574||||||Analysis for Midazolam|
1618666|NCT02370615|2972672|Superiority or Other||Geometric Mean Ratio (Day 7/Day 1)|1.081|||||2-Sided|90.0|1.008|1.16||||||Analysis for 1’Hydroxymidazolam|
1618667|NCT02370615|2972672|Superiority or Other||Geometric Mean Ratio (Day 7/Day 1)|1.422|||||2-Sided|90.0|1.29|1.568||||||Analysis for Midazolam|
1618668|NCT02370615|2972673|Superiority or Other||Geometric Mean Ratio (Day 7/Day 1)|0.887|||||2-Sided|90.0|0.781|1.008||||||Analysis for 1’Hydroxymidazolam|
1618669|NCT02370615|2972673|Superiority or Other||Geometric Mean Ratio (Day 7/Day 1)|1.235|||||2-Sided|90.0|1.1|1.387||||||Analysis for Midazolam|
1618670|NCT02370615|2972675|Superiority or Other||Geometric Mean Ratio (Day 7/Day 1)|1.155|||||2-Sided|90.0|1.035|1.289|||||||
1618671|NCT02370615|2972676|Superiority or Other||Geometric Mean Ratio (Day 7/Day 1)|1.02|||||2-Sided|90.0|0.919|1.131|||||||
1618672|NCT02370615|2972677|Superiority or Other||Geometric Mean Ratio (Day 7/Day 1)|1.349|||||2-Sided|90.0|1.117|1.628|||||||
1618673|NCT02370615|2972679|Superiority or Other||Geometric Mean Ratio (Day 10/Day 1)|0.023|||||2-Sided|90.0|0.012|0.045||||||Analysis for TAK 272-M-I|
1618674|NCT02370615|2972679|Superiority or Other||Geometric Mean Ratio (Day 10/Day 1)|4.702|||||2-Sided|90.0|3.969|5.569||||||Analysis for TAK 272F|
1618675|NCT02370615|2972680|Superiority or Other||Geometric Mean Ratio (Day 10/Day 1)|4.888|||||2-Sided|90.0|4.137|5.777||||||Analysis for TAK 272F|
1618676|NCT02370615|2972681|Superiority or Other||Geometric Mean Ratio (Day 10/Day 1)|0.089|||||2-Sided|90.0|0.064|0.123||||||Analysis for TAK 272-M-I|
1618677|NCT02370615|2972681|Superiority or Other||Geometric Mean Ratio (Day 10/Day 1)|2.012|||||2-Sided|90.0|1.632|2.481||||||Analysis for TAK 272F|
1618678|NCT02370537|2972700|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.7|||||2-Sided|90.0|0.54|0.9|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618679|NCT02370537|2972700|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.6|||||2-Sided|90.0|0.42|0.84|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618680|NCT02370537|2972700|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean|0.68|||||2-Sided|90.0|0.49|0.92|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618681|NCT02370537|2972701|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.11|||||2-Sided|90.0|0.88|1.4|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618682|NCT02370537|2972701|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS mean Ratio|0.92|||||2-Sided|90.0|0.67|1.25|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618683|NCT02370537|2972701|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of least-squares LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.02|||||2-Sided|90.0|0.77|1.36|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618684|NCT02370537|2972702|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.53|||||2-Sided|90.0|0.4|0.7|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618685|NCT02370537|2972702|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.46|||||2-Sided|90.0|0.32|0.67|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618686|NCT02370537|2972702|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.52|||||2-Sided|90.0|0.37|0.73|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618687|NCT02370537|2972703|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.75|||||2-Sided|90.0|0.55|1.0|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618688|NCT02370537|2972703|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.58|||||2-Sided|90.0|0.39|0.85|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618689|NCT02370537|2972703|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.9|||||2-Sided|90.0|0.63|1.28|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618690|NCT02370537|2972704|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.29|||||2-Sided|90.0|0.92|1.82|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618691|NCT02370537|2972704|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.8|||||2-Sided|90.0|0.51|1.25|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618692|NCT02370537|2972704|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|1.28|||||2-Sided|90.0|0.84|1.93|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618693|NCT02370537|2972705|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean Ratio|0.6|||||2-Sided|90.0|0.44|0.82|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618694|NCT02370537|2972705|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of LSmeans for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% CIs by degree of pancreatic exocrine function using level of FEC were exponentiated.|GLS Mean ratio|0.48|||||2-Sided|90.0|0.32|0.72|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618695|NCT02370537|2972705|Non-Inferiority or Equivalence|The exposure of a single dose of EPANOVA® 4 g (reference) relative to OMACOR® 4 g (test) was estimated by degree of pancreatic exocrine function using level of FEC. Natural log estimates of least-square means (LSmeans) for each treatment and differences of the LSmeans (OMACOR®-EPANOVA®) along with 90% Confidence Intervals (CIs) by degree of pancreatic exocrine function using level of FEC were exponentiated.|Geometric least-squares (GLS) Mean Ratio|0.75|||||2-Sided|90.0|0.52|1.1|||||OMACOR®/EPANOVA®|Back transformed results are based on the analysis of natural log-transformed data with a Linear Mixed Model containing the terms of FEC classification, treatment, FEC x treatment, sequence, and period as fixed effects and patient nested within sequence as random effect.|
1618696|NCT02370498|2972707|Other||Difference in Percentage|-4.0|||||2-Sided|95.0|-8.4|0.3||||||Between-treatment differences (Pembrolizumab vs. Paclitaxel) in the percentage of participants with events and accompanying 95% confidence intervals were based on the Miettinen and Nurminen method. Negative values correspond to a greater percentage of events for Paclitaxel.|
1618697|NCT02370498|2972709|Other||Difference in Percentage|-3.2|||||2-Sided|95.0|-6.9|0.2||||||Between-treatment differences (Pembrolizumab vs. Paclitaxel) in the percentage of participants with events and accompanying 95% confidence intervals were based on the Miettinen and Nurminen method. Negative values correspond to a greater percentage of events for Paclitaxel.|
1618698|NCT02370498|2972715|Other||Difference in Percentage|-3.0||||0.85922|2-Sided|95.0|-8.5|2.6||Stratification factors included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified Miettinen and Nurminen’s method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm is provided.|
1618699|NCT02370498|2972716|Other||Difference in Percentage|1.6||||0.3322|2-Sided|95.0|-5.8|9.1||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (<6 months vs. ≥6 months), weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.|
1618700|NCT02370498|2972717|Other||Difference in Percentage|-1.3||||0.6901|2-Sided|95.0|-6.5|4.0||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative) weighting by sample size|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified MN method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.|
1618701|NCT02370498|2972718|Other||Difference in Percentage|2.0||||0.28967|2-Sided|95.0|-5.0|9.1||Stratification factors for MN method included geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (<6 months vs. ≥6 months) weighting by sample size.|Miettinen and Nurminen method|P-value rounded to 5 decimal places.||Stratified Miettinen and Nurminen’s (MN) method was used for comparison of the ORR between the treatment arms. A 95% CI for the difference in response rates between the pembrolizumab arm and paclitaxel arm was provided.|
1618702|NCT02370498|2972719|Other||Hazard Ratio (HR)|1.21||||0.97033|2-Sided|95.0|1.0|1.47||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (< 6 months vs. >= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.|
1618703|NCT02370498|2972720|Other||Hazard Ratio (HR)|0.97||||0.3928|2-Sided|95.0|0.77|1.23||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.|
1618704|NCT02370498|2972721|Other||Hazard Ratio (HR)|1.77||||1|2-Sided|95.0|1.42|2.2||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (< 6 months vs. >= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.|
1618705|NCT02370498|2972722|Other||Hazard Ratio (HR)|1.45||||0.99661|2-Sided|95.0|1.11|1.89||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in TTP was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.|
1618706|NCT02370498|2972723|Other||Hazard Ratio (HR)|1.34||||0.99932|2-Sided|95.0|1.12|1.6||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (< 6 months vs. >= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.|
1618707|NCT02370498|2972724|Other||Hazard Ratio (HR)|1.11||||0.80696|2-Sided|95.0|0.89|1.38||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.|
1618708|NCT02370498|2972725|Other||Hazard Ratio (HR)|1.19||||0.97481|2-Sided|95.0|1.0|1.42||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.|
1618709|NCT02370498|2972726|Other||Hazard Ratio (HR)|0.98||||0.41331|2-Sided|95.0|0.79|1.21||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (<6 months vs. ≥6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.|
1618710|NCT02370498|2972727|Other||Hazard Ratio (HR)|0.94||||0.24463|2-Sided|95.0|0.79|1.12||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (<6 months vs. ≥6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio [HR]) between the treatment arms.|
1618752|NCT02369874|2972815|Superiority||Odds Ratio (OR)|0.96|||||2-Sided|95.0|0.64|1.46||||||6 Month analysis|
1618711|NCT02370498|2972728|Other||Hazard Ratio (HR)|1.49||||0.99999|2-Sided|95.0|1.25|1.77||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World), TTP on first-line therapy (< 6 months vs. >= 6 months), and PD-L1 status (positive vs. negative).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio [HR]) between the treatment arms.|
1618712|NCT02370498|2972729|Other||Hazard Ratio (HR)|0.82||||0.04205|2-Sided|95.0|0.66|1.03||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (< 6 months vs. >= 6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in OS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (HR) between the treatment arms.|
1618713|NCT02370498|2972730|Other||Hazard Ratio (HR)|1.27||||0.98358|2-Sided|95.0|1.03|1.57||One-sided p-value based on log-rank test stratified by geographic region (Europe/Israel/North America/Australia vs. Asia vs. Rest of World) and TTP on first-line therapy (< 6 months vs. >= 6 months).|Regression, Cox|P-value rounded to 5 decimal places.||Treatment difference in PFS was assessed by the Stratified Log-rank test, and a stratified Cox proportional hazard model with Efron's method of tie handling was used to assess the magnitude of the treatment difference (Hazard Ratio [HR]) between the treatment arms.|
1618714|NCT02370394|2972743|Superiority|||||||0.2467|||||||Wilcoxon (Mann-Whitney)|||Change in Readiness from Baseline to Follow Up|
1618715|NCT02370394|2972743|Superiority|||||||0.4085|||||||Wilcoxon (Mann-Whitney)|||Readiness at Follow Up|
1618716|NCT02370394|2972744|Superiority|||||||0.3256|||||||Wilcoxon (Mann-Whitney)|||Change in Motivation Scale from Baseline to Follow Up|
1618717|NCT02370394|2972744|Superiority|||||||0.9085|||||||Wilcoxon (Mann-Whitney)|||Motivation Scale at Follow Up|
1618718|NCT02370394|2972745|Superiority||Mean Difference (Net)|-0.86||||0.3045|2-Sided|95.0|-2.54|0.82|||t-test, 2 sided|||Change in Number of Issues Effective at Accomplishing from Baseline to Follow Up|
1618719|NCT02370394|2972745|Superiority||Mean Difference (Final Values)|-0.13||||0.8646|2-Sided|95.0|-1.62|1.36|||t-test, 2 sided|Unequal variances handled by Satterthwaite's degrees of freedom||EOR Number of issues Effective at Accomplishing at Follow Up|
1618720|NCT02370394|2972746|Superiority||Mean Difference (Net)|-0.01||||0.9116|2-Sided|95.0|-0.16|0.15|||t-test, 2 sided|||Change is Safety Behavior Change Score from Baseline to Follow Up|
1618721|NCT02370394|2972746|Superiority||Mean Difference (Final Values)|-0.04||||0.6011|2-Sided|95.0|-0.21|0.12|||t-test, 2 sided|||Safety Behavior Change Score at Follow Up|
1618722|NCT02370394|2972747|Superiority||Mean Difference (Net)|14.46||||0.0072|2-Sided|95.0|4.11|24.82|||t-test, 2 sided|||Change in CAS Victimization Total score from Baseline to Follow Up|
1618723|NCT02370394|2972747|Superiority||Mean Difference (Final Values)|-4.14||||0.4016|2-Sided|95.0|-14.02|5.75|||t-test, 2 sided|Unequal variances handled by Satterthwaite's degrees of freedom||CAS Victimization Total Score at Follow Up|
1618724|NCT02370160|2972757|Other||||||||||||||||||In Phase I: There were 9 subjects treated on dose level 1 (60 µg/kg/dose). There were 6 subjects treated on Dose level 2 (80 µg/kg/dose). There were four DLT events happened in Phase I. One was treated on dose level 1 and the other three were treated on dose level 2. Therefore the MTD was dose level 1.
1618725|NCT02370121|2972758|Superiority or Other|||||||0.89|||||||Wilcoxon (Mann-Whitney)||||
1618726|NCT02370121|2972759|Superiority or Other|||||||0.17|||||||Wilcoxon (Mann-Whitney)||||
1618727|NCT02370121|2972760|Superiority or Other|||||||0.32|||||||Wilcoxon (Mann-Whitney)||||
1618728|NCT02370121|2972761|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1618729|NCT02370121|2972762|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)||||
1618730|NCT02370121|2972763|Superiority or Other|||||||0.83|||||||Wilcoxon (Mann-Whitney)||||
1618731|NCT02370121|2972764|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1618732|NCT02370121|2972765|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1618733|NCT02370121|2972766|Superiority or Other|||||||0.17|||||||Wilcoxon (Mann-Whitney)||||
1618734|NCT02370121|2972767|Superiority or Other|||||||0.77|||||||Wilcoxon (Mann-Whitney)||||
1618735|NCT02370121|2972768|Superiority or Other|||||||0.42|||||||Wilcoxon (Mann-Whitney)||||
1618736|NCT02370121|2972769|Superiority or Other|||||||0.92|||||||Wilcoxon (Mann-Whitney)||||
1618737|NCT02370121|2972770|Superiority or Other|||||||0.95|||||||Wilcoxon (Mann-Whitney)||||
1618738|NCT02370121|2972771|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1618739|NCT02370121|2972772|Superiority or Other|||||||0.79|||||||Wilcoxon (Mann-Whitney)||||
1618740|NCT02370121|2972773|Superiority or Other|||||||0.07|||||||Wilcoxon (Mann-Whitney)||||
1618741|NCT02370121|2972774|Superiority or Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)||||
1618742|NCT02370095|2972777|Superiority|||||||0.5055|||||||Fisher Exact||||
1618743|NCT02370095|2972779|Superiority|||||||0.2507||||||The threshold for statistical significance was 0.05|Fisher Exact||||
1618744|NCT02370095|2972780|Superiority|||||||0.567|||||||Mixed Models Analysis|Measurement of MAP were evaluated from baseline to end of treatment|||
1618745|NCT02370095|2972785|Superiority|||||||0.0679|||||||Wilcoxon (Mann-Whitney)||||
1618746|NCT02370095|2972786|Superiority|||||||0.06|||||||Mixed Models Analysis|The change in S/F ratio over time was evaluated using a mixed model for repeated measures|||
1618747|NCT02370095|2972787|Superiority|||||||0.2416|||||||Wilcoxon (Mann-Whitney)|||Only one placebo subject had data to allow for change from baseline to be calculated|
1618748|NCT02369874|2972811|Superiority||Odds Ratio (OR)|1.33|||||2-Sided|95.0|0.74|2.39|||||||
1618749|NCT02369874|2972812|Superiority||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.76|1.21|||||||
1618750|NCT02369874|2972815|Superiority||Odds Ratio (OR)|1.0|||||2-Sided|95.0|0.63|1.57||||||12 Month analysis|
1618751|NCT02369874|2972815|Superiority||Odds Ratio (OR)|1.12|||||2-Sided|95.0|0.72|1.75||||||12 Month analysis|
1618753|NCT02369874|2972815|Superiority||Odds Ratio (OR)|1.01|||||2-Sided|95.0|0.67|1.52||||||6 Month analysis|
1618754|NCT02369874|2972817|Superiority||Odds Ratio (OR)|1.05|||||2-Sided|95.0|0.66|1.68|||||||
1618755|NCT02369874|2972817|Superiority||Odds Ratio (OR)|1.07|||||2-Sided|95.0|0.67|1.7|||||||
1618756|NCT02369874|2972818|Superiority||Hazard Ratio (HR)|1.02|||||2-Sided|95.0|0.84|1.25|||||||
1618757|NCT02369874|2972818|Superiority||Hazard Ratio (HR)|1.09|||||2-Sided|95.0|0.9|1.33|||||||
1618758|NCT02369874|2972819|Superiority||Hazard Ratio (HR)|0.93|||||2-Sided|95.0|0.63|1.39|||||||
1618759|NCT02369874|2972820|Superiority||Hazard Ratio (HR)|1.08|||||2-Sided|95.0|0.85|1.36|||||||
1618760|NCT02369874|2972820|Superiority||Hazard Ratio (HR)|0.92||||0.459|2-Sided|95.0|0.73|1.17|||Log Rank||||
1618761|NCT02369874|2972821|Superiority||Hazard Ratio (HR)|0.88||||0.1993|2-Sided|95.0|0.72|1.08|||Log Rank||||
1618762|NCT02369874|2972821|Superiority||Hazard Ratio (HR)|1.04||||0.7624|2-Sided|95.0|0.85|1.26|||Log Rank||||
1618763|NCT02369835|2972835|Other|||||||0.8872|||||||Chi-squared||||
1618764|NCT02369068|2972917|Other|||||||0.285|||||||Kruskal-Wallis|||The null hypothesis assumed that there was no difference in the distribution between the groups. Significance level was set at 0.05|
1618765|NCT02369068|2972918|Other|||||||0.571|||||||Kruskal-Wallis|||The null hypothesis assumed that there is no difference in the change in pain interference between the groups. Statistical significance was set at 0.05|
1618766|NCT02369068|2972919|Other|||||||0.624|||||||Kruskal-Wallis|||The null hypothesis assumed there were no differences in the median change pain severity between the groups. Significance level was set at 0.05|
1618767|NCT02369068|2972920|Other|||||||0.072|||||||Kruskal-Wallis|This test was selected since the distribution of the change in pain was not normal nor approximately symmetric.||The null hypothesis assumed there were no differences in the pain score change between groups. Significance level was set at 0.05.|
1618768|NCT02368886|2972927|Superiority||Hazard Ratio (HR)|0.85||||0.4614|2-Sided|95.0|0.55|1.31|||Log Rank||||
1618769|NCT02368886|2972928|Superiority||Hazard Ratio (HR)|0.84||||0.3797|2-Sided|95.0|0.57|1.24|||Log Rank||||
1618770|NCT02368886|2972929|Superiority||Hazard Ratio (HR)|0.72||||0.1241|2-Sided|95.0|0.47|1.1|||Log Rank||||
1618771|NCT02368886|2972930|Superiority||Risk Difference (RD)|0.17||||0.0434|2-Sided|95.0|0.0|0.34||1-sided|Fisher Exact||||
1618772|NCT02368314|2972951|Superiority or Other|||||||0.226|||||||Fisher Exact||||
1618773|NCT02368210|2972956|Superiority||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: Plaque Elevation.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).|
1618774|NCT02368210|2972956|Superiority||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: erythema.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).|
1618775|NCT02368210|2972956|Superiority||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05. The reported P-Value applies to the clinical sign of psoriasis: Scaling.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).|
1618776|NCT02368210|2972957|Superiority||||||<|0.001||||||Treatment groups were compared with respect to the proportions of subjects with “treatment success” at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.|||
1618777|NCT02367872|2973001|Superiority or Other||LS Mean Cohort Ratio (%)|325.28|||||2-Sided|95.0|211.32|500.7||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618778|NCT02367872|2973001|Superiority or Other||LS Mean Cohort Ratio (%)|135.08|||||2-Sided|95.0|87.75|207.92||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618779|NCT02367872|2973001|Superiority or Other||LS Mean Cohort Ratio (%)|139.7|||||2-Sided|95.0|92.88|210.11||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618780|NCT02367872|2973001|Superiority or Other||LS Mean Cohort Ratio (%)|111.68|||||2-Sided|95.0|74.25|167.96||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618781|NCT02367872|2973001|Superiority or Other||LS Mean Cohort Ratio (%)|98.01|||||2-Sided|95.0|65.17|147.41||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618782|NCT02367872|2973001|Superiority or Other||LS Mean Cohort Ratio (%)|60.68|||||2-Sided|95.0|40.35|91.27||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618783|NCT02367872|2973002|Superiority or Other||LS Mean Cohort Ratio (%)|312.89|||||2-Sided|95.0|192.34|509.0||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618784|NCT02367872|2973002|Superiority or Other||LS Mean Cohort Ratio (%)|113.25|||||2-Sided|95.0|69.62|184.24||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618785|NCT02367872|2973002|Superiority or Other||LS Mean Cohort Ratio (%)|108.54|||||2-Sided|95.0|67.7|174.01||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618786|NCT02367872|2973002|Superiority or Other||LS Mean Cohort Ratio (%)|84.45|||||2-Sided|95.0|52.67|135.38||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618787|NCT02367872|2973002|Superiority or Other||LS Mean Cohort Ratio (%)|63.7|||||2-Sided|95.0|39.73|102.12||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618788|NCT02367872|2973002|Superiority or Other||LS Mean Cohort Ratio (%)|67.61|||||2-Sided|95.0|42.17|108.39||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618789|NCT02367872|2973003|Superiority or Other||LS Mean Cohort Ratio (%)|323.75|||||2-Sided|95.0|210.54|497.85||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618790|NCT02367872|2973003|Superiority or Other||LS Mean Cohort Ratio (%)|135.18|||||2-Sided|95.0|87.91|207.87||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618791|NCT02367872|2973003|Superiority or Other||LS Mean Cohort Ratio (%)|138.79|||||2-Sided|95.0|92.29|208.7||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618792|NCT02367872|2973003|Superiority or Other||LS Mean Cohort Ratio (%)|111.6|||||2-Sided|95.0|74.21|167.82||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618793|NCT02367872|2973003|Superiority or Other||LS Mean Cohort Ratio (%)|97.39|||||2-Sided|95.0|64.77|146.46||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618794|NCT02367872|2973003|Superiority or Other||LS Mean Cohort Ratio (%)|60.22|||||2-Sided|95.0|40.05|90.56||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618795|NCT02367872|2973004|Superiority or Other||LS Mean Cohort Ratio (%)|192.63|||||2-Sided|95.0|120.94|306.83||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618796|NCT02367872|2973004|Superiority or Other||LS Mean Cohort Ratio (%)|130.07|||||2-Sided|95.0|81.66|207.18||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618797|NCT02367872|2973004|Superiority or Other||LS Mean Cohort Ratio (%)|319.06|||||2-Sided|95.0|183.31|555.34||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618798|NCT02367872|2973004|Superiority or Other||LS Mean Cohort Ratio (%)|260.03|||||2-Sided|95.0|149.39|452.6||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618799|NCT02367872|2973004|Superiority or Other||LS Mean Cohort Ratio (%)|97.04|||||2-Sided|95.0|55.75|168.9||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618800|NCT02367872|2973004|Superiority or Other||LS Mean Cohort Ratio (%)|59.17|||||2-Sided|95.0|33.99|102.99||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618801|NCT02367872|2973004|Superiority or Other||LS Mean Cohort Ratio (%)|136.59|||||2-Sided|95.0|92.78|201.09||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618802|NCT02367872|2973004|Superiority or Other||LS Mean Cohort Ratio (%)|101.64|||||2-Sided|95.0|69.04|149.64||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618803|NCT02367872|2973004|Superiority or Other||LS Mean Cohort Ratio (%)|184.13|||||2-Sided|95.0|127.02|266.91||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618804|NCT02367872|2973004|Superiority or Other||LS Mean Cohort Ratio (%)|272.83|||||2-Sided|95.0|188.21|395.5||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618805|NCT02367872|2973004|Superiority or Other||LS Mean Cohort Ratio (%)|118.43|||||2-Sided|95.0|81.7|171.68||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618806|NCT02367872|2973004|Superiority or Other||LS Mean Cohort Ratio (%)|51.39|||||2-Sided|95.0|35.45|74.49||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618807|NCT02367872|2973005|Superiority or Other||LS Mean Cohort Ratio (%)|139.33|||||2-Sided|95.0|74.91|259.15||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618808|NCT02367872|2973005|Superiority or Other||LS Mean Cohort Ratio (%)|91.97|||||2-Sided|95.0|49.45|171.06||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618834|NCT02367781|2973051|Superiority||Hazard Ratio (HR)|0.64|||<|0.0001|2-Sided|95.0|0.54|0.77|||Stratified Log Rank Test||||
1619470|NCT02349152|2974757|Superiority|||||||0.93|||||||Chi-squared|||Prolonged Mechanical Ventilation|
1618809|NCT02367872|2973005|Superiority or Other||LS Mean Cohort Ratio (%)|103.93|||||2-Sided|95.0|59.7|180.95||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618810|NCT02367872|2973005|Superiority or Other||LS Mean Cohort Ratio (%)|125.96|||||2-Sided|95.0|72.35|219.3||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618811|NCT02367872|2973005|Superiority or Other||LS Mean Cohort Ratio (%)|55.03|||||2-Sided|95.0|31.61|95.81||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618812|NCT02367872|2973005|Superiority or Other||LS Mean Cohort Ratio (%)|70.38|||||2-Sided|95.0|40.42|122.53||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618813|NCT02367872|2973005|Superiority or Other||LS Mean Cohort Ratio (%)|131.63|||||2-Sided|95.0|78.74|220.04||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618814|NCT02367872|2973005|Superiority or Other||LS Mean Cohort Ratio (%)|85.31|||||2-Sided|95.0|51.03|142.61||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618815|NCT02367872|2973005|Superiority or Other||LS Mean Cohort Ratio (%)|143.11|||||2-Sided|95.0|94.21|217.39||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618816|NCT02367872|2973005|Superiority or Other||LS Mean Cohort Ratio (%)|206.41|||||2-Sided|95.0|135.88|313.54||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618817|NCT02367872|2973005|Superiority or Other||LS Mean Cohort Ratio (%)|77.04|||||2-Sided|95.0|50.72|117.03||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618818|NCT02367872|2973005|Superiority or Other||LS Mean Cohort Ratio (%)|57.36|||||2-Sided|95.0|37.76|87.14||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618819|NCT02367872|2973006|Superiority or Other||LS Mean Cohort Ratio (%)|176.75|||||2-Sided|95.0|108.97|286.67||||||M-I: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618820|NCT02367872|2973006|Superiority or Other||LS Mean Cohort Ratio (%)|112.47|||||2-Sided|95.0|69.34|182.41||||||M-I: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618821|NCT02367872|2973006|Superiority or Other||LS Mean Cohort Ratio (%)|261.12|||||2-Sided|95.0|151.5|450.05||||||M-I: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618822|NCT02367872|2973006|Superiority or Other||LS Mean Cohort Ratio (%)|274.21|||||2-Sided|95.0|159.1|472.63||||||M-I: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618823|NCT02367872|2973006|Superiority or Other||LS Mean Cohort Ratio (%)|93.2|||||2-Sided|95.0|54.08|160.64||||||M-I: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618824|NCT02367872|2973006|Superiority or Other||LS Mean Cohort Ratio (%)|62.34|||||2-Sided|95.0|36.17|107.45||||||M-I: LS mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618825|NCT02367872|2973006|Superiority or Other||LS Mean Cohort Ratio (%)|135.98|||||2-Sided|95.0|92.23|200.5||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618826|NCT02367872|2973006|Superiority or Other||LS Mean Cohort Ratio (%)|101.67|||||2-Sided|95.0|68.95|149.9||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 2H) and the reference group (Cohort 1H) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618827|NCT02367872|2973006|Superiority or Other||LS Mean Cohort Ratio (%)|183.27|||||2-Sided|95.0|126.36|265.81||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 5R-Part 2) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618828|NCT02367872|2973006|Superiority or Other||LS Mean Cohort Ratio (%)|272.87|||||2-Sided|95.0|188.14|395.76||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 4R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618829|NCT02367872|2973006|Superiority or Other||LS Mean Cohort Ratio (%)|117.95|||||2-Sided|95.0|81.32|171.07||||||TAK-272F: LS mean cohort ratios for the test groups (Cohort 3R) and the reference group (Cohort 1R) with their 95% CIs were calculated using an ANOVA model for natural log-transformed data.|
1618830|NCT02367872|2973006|Superiority or Other||LS Mean Cohort Ratio (%)|51.08|||||2-Sided|95.0|35.22|74.08||||||TAK-272F: Least square mean (LS) mean cohort ratios for the test groups (Cohort 2R) and the reference group (Cohort 1R) with their 95 percent (%) confidence intervals (CI) were calculated using an analysis of variance (ANOVA) model for natural log-transformed data.|
1618831|NCT02367794|2973035|Superiority||Hazard Ratio (HR)|0.88||||0.1581|2-Sided|95.0|0.73|1.05|||Log Rank||||
1618832|NCT02367794|2973036|Superiority||Hazard Ratio (HR)|0.75||||0.0006|2-Sided|95.0|0.64|0.88|||Log Rank||||
1618833|NCT02367781|2973050|Superiority||Hazard Ratio (HR)|0.79||||0.0331|2-Sided|95.0|0.64|0.98|||Stratified Log Rank Test||||
1619471|NCT02349152|2974757|Superiority|||||||0.24|||||||Chi-squared|||Cerebral Vascular Accident|
1618835|NCT02367729|2973057|Superiority||Mean Difference (Final Values)|2.15|Standard Error of the Mean|0.3947||0.003|2-Sided|95.0|1.37|2.93|||Wilcoxon (Mann-Whitney)||||
1618836|NCT02367066|2973136|Superiority or Other||LS Mean Difference|0.01|Standard Error of the Mean|0.01||0.45|2-Sided|90.0|-0.01|0.03||2-sided|Mixed Models Analysis||||
1618837|NCT02367066|2973137|Superiority or Other||Geometric LS Mean Ratio|1.02|Standard Error of the Mean|0.01||0.06|2-Sided|80.0|1.0|1.04||1-sided|Mixed Models Analysis||||
1618838|NCT02367066|2973139|Superiority or Other||Geometric LS MEan Ratio|1.0|Standard Error of the Mean|0.05||0.37|2-Sided|80.0|0.91|1.06||1-sided|Mixed Models Analysis||||
1618839|NCT02367066|2973141|Superiority or Other||Geometric LS Mean Ratio|0.93|Standard Error of the Mean|0.04||0.04|2-Sided|80.0|0.89|0.98||1-sided|Mixed Models Analysis||||
1618840|NCT02367066|2973142|Superiority or Other||Geometric LS Mean Ratio|1.06|Standard Error of the Mean|0.04||0.18|2-Sided|80.0|0.99|1.13||1-sided|Mixed Models Analysis||||
1618841|NCT02367066|2973143|Superiority or Other||Geometric LS Mean Ratio|0.92|Standard Error of the Mean|0.05||0.06|2-Sided|80.0|0.85|0.99||1-sided|Mixed Models Analysis||||
1618842|NCT02367066|2973144|Superiority or Other||Geometric LS Mean Ratio|0.99|Standard Error of the Mean|0.03||0.41|2-Sided|80.0|0.96|1.03||1-sided|Mixed Models Analysis||||
1618843|NCT02367066|2973145|Superiority or Other||Geometric LS Mean Ratio|0.96|Standard Error of the Mean|0.03||0.06|2-Sided|80.0|0.92|0.99||1-sided|Mixed Models Analysis||||
1618844|NCT02367066|2973146|Superiority or Other||Geometric LS Mean Ratio|0.94|Standard Error of the Mean|0.02||0.02|2-Sided|80.0|0.9|0.98||1-sided|Mixed Models Analysis||||
1618845|NCT02366689|2973199|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1618846|NCT02366689|2973200|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1618847|NCT02366689|2973201|Superiority or Other|||||||0.432|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1618848|NCT02366689|2973202|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1618849|NCT02366689|2973203|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1618850|NCT02366689|2973204|Superiority or Other|||||||0.04|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1618851|NCT02366468|2973228|Superiority||Mean Difference (Final Values)|-1.5||||0.925|2-Sided|95.0|-33.66|30.59|||ANCOVA|containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates|||
1618852|NCT02366468|2973229|Superiority||Mean Difference (Final Values)|5.7||||0.62|2-Sided|95.0|-17.1|28.56|||ANCOVA|containing the baseline values of the dependent variables as continuous covariates, and center and treatment as categorical covariates|||
1618853|NCT02366468|2973233|Non-Inferiority|non-inferiority margin: -4 letters|Median Difference (Final Values)|-0.9||||0.002|2-Sided|95.0|-3.04|1.27|||ANCOVA|including study treatment (DI, PRN) and center as factors and baseline BCVA as continuous covariate.||The primary objective was to demonstrate that the mean visit-averaged change from baseline of BCVA over month 1 to treatment completion for the DI arm was non-inferior to the PRN arm.|
1618854|NCT02366195|2973242|Other|||||||0.18|||||||Fisher’s Z transformation||||
1618855|NCT02366195|2973243|Other|||||||0.626|||||||Cox proportional hazards||||
1618856|NCT02366195|2973244|Other|||||||0.974|||||||Regression, Logistic||||
1618857|NCT02366195|2973245|Other|||||||0.66|||||||Regression, Logistic||||
1618858|NCT02366195|2973246|Other|||||||0.82|||||||Fisher’s Z transformation||||
1618859|NCT02366195|2973247|Other|||||||0.335|||||||Cox proportional hazards||||
1618860|NCT02366195|2973248|Other|||||||0.056|||||||Regression, Logistic||||
1618861|NCT02366195|2973249|Other|||||||0.387|||||||Regression, Logistic||||
1618862|NCT02365636|2973262|Superiority||LSM difference from placebo|0.0||||0.871|2-Sided|95.0|-0.64|0.55||5% level of siignificance|mixed model for repeated measures|||Change from baseline at week 4. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.|
1618863|NCT02365636|2973262|Superiority||LSM difference from placebo|0.1||||0.714|2-Sided|95.0|-0.49|0.71||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.|
1618864|NCT02365636|2973262|Superiority||LSM difference from placebo|-0.1||||0.804|2-Sided|95.0|-0.64|0.5||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.|
1618865|NCT02365636|2973262|Superiority||LSM difference from placebo|-0.2||||0.563|2-Sided|95.0|-0.75|0.41||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.|
1618866|NCT02365636|2973263|Superiority||LSM difference from placebo|-0.1||||0.833|2-Sided|95.0|-0.62|0.5||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.|
1618867|NCT02365636|2973263|Superiority||LSM difference from placebo|-0.3||||0.333|2-Sided|95.0|-0.81|0.28||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4. The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.|
1619472|NCT02349152|2974757|Superiority|||||||0.03|||||||Chi-squared|||30-day readmission|
1619473|NCT02349152|2974757|Superiority|||||||0.06|||||||Chi-squared|||30-day mortality|
1618868|NCT02365636|2973263|Superiority||LSM difference from placebo|-0.2||||0.482|2-Sided|95.0|-0.65|0.31||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.|
1618869|NCT02365636|2973263|Superiority||LSM difference from placebo|-0.1||||0.556|2-Sided|95.0|-0.61|0.33||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.|
1618870|NCT02365636|2973264|Superiority|||||||0.304||||||5% level of significance|Regression, Cox||||
1618871|NCT02365636|2973264|Superiority|||||||0.245||||||5% level of significance|Regression, Cox||||
1618872|NCT02365636|2973265|Superiority||LSM difference from placebo|0.3||||0.296|2-Sided|95.0|-0.23|0.76||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.|
1618873|NCT02365636|2973265|Superiority||LSM difference from placebo|0.5||||0.065|2-Sided|95.0|-0.03|0.97||5% level of significance|mixed model for repeated measures|||Change from baseline at week 4 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.|
1618874|NCT02365636|2973265|Superiority||LSM difference from placebo|0.3||||0.262|2-Sided|95.0|-0.2|0.73||5% level of significance|mixed model for repeated measures|||Change from baseline at week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.|
1618875|NCT02365636|2973265|Superiority||LSM difference from placebo|0.2||||0.311|2-Sided|95.0|-0.22|0.7||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2 The inferential model includes study center, week, treatment, and treatment by week interaction as the fixed factors; baseline as a covariate and unstructured variance-covariance structure in the initial model.|
1618876|NCT02365636|2973266|Superiority||LSM difference from placebo|0.1||||0.342|2-Sided|95.0|-0.16|0.46||5% level of significance|mixed model for repeated measures|||Week 4 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.|
1618877|NCT02365636|2973266|Superiority||LSM difference from placebo|0.2||||0.152|2-Sided|95.0|-0.08|0.53||5% level of significance|mixed model for repeated measures|||Week 4 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.|
1618878|NCT02365636|2973266|Superiority||LSM difference from placebo|0.3||||0.046|2-Sided|95.0|0.0|0.51||5% level of significance|mixed model for repeated measures|||Week 2 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.|
1618879|NCT02365636|2973266|Superiority||LSM difference from placebo|0.2||||0.166|2-Sided|95.0|-0.07|0.43||5% level of significance|mixed model for repeated measures|||Week 2 Mixed model for repeated measures (MMRM) with pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.|
1618880|NCT02365636|2973267|Superiority||LSM difference with placebo|2.1||||0.427|2-Sided|95.0|-3.05|7.19||5% level of significance|ANCOVA|ANCOVA model includes study center, treatment, and baseline.|||
1618881|NCT02365636|2973267|Superiority||LSM difference from placebo|1.3||||0.609|2-Sided|95.0|-3.81|6.48||5% level of significance|ANCOVA|ANCOVA model includes study center, treatment, and baseline.|||
1618882|NCT02365636|2973268|Superiority||LSM difference from placebo|2.8||||0.16|2-Sided|95.0|-1.12|6.77||5% level of significance.|miex model for repeated measures|||Change from baseline at Week 4. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.|
1618883|NCT02365636|2973268|Superiority||LSM difference from placebo|3.1||||0.123|2-Sided|95.0|-0.84|7.06||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 4. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.|
1618884|NCT02365636|2973268|Superiority||LSM difference from placebo|1.3||||0.495|2-Sided|95.0|-2.46|5.07||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2. The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.|
1618885|NCT02365636|2973268|Superiority||LSM of difference with placebo|2.2||||0.251|2-Sided|95.0|-1.55|5.92||5% level of significance|mixed model for repeated measures|||Change from baseline at Week 2 The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used.|
1618886|NCT02365636|2973269|Superiority||Odds Ratio (OR)|1.02||||0.967|2-Sided|95.0|0.494|2.088||5% level of significance|Regression, Logistic|||>=50% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.|
1618887|NCT02365636|2973269|Superiority||Odds Ratio (OR)|0.74||||0.43|2-Sided|95.0|0.357|1.55||5% level of significance|Regression, Logistic|||>=50% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.|
1619560|NCT02347176|2974935|Superiority||Odds Ratio (OR)|0.98||||0.974|2-Sided|95.0|0.29|3.32|||Regression, Logistic||||
1618888|NCT02365636|2973269|Superiority||Odds Ratio (OR)|1.05||||0.893|2-Sided|95.0|0.52|2.117||5% level of significance|Regression, Logistic|||>=30% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.|
1618889|NCT02365636|2973269|Superiority||Odds Ratio (OR)|0.92||||0.815|2-Sided|95.0|0.456|1.856||5% level of significance|Regression, Logistic|||>=30% improvement. P-value, odds ratio and CI for odds ratio are calculated using logistic model including response (yes/no) as dependent variable, treatment group and pooled study sites as factors.|
1618890|NCT02365636|2973270|Superiority||LSM difference from placebo|0.457||||0.457|2-Sided|95.0|-0.28|0.621||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the worst NRS pain scores recorded in the evening as covariate; and patient as a random effect.|
1618891|NCT02365636|2973270|Superiority||LSM difference from placebo|0.29||||0.202|2-Sided|95.0|-0.158|0.741||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the worst NRS pain scores recorded in the evening as covariate; and patient as a random effect.|
1618892|NCT02365636|2973271|Superiority||LSM difference from placebo|0.2||||0.325|2-Sided|95.0|-0.204|0.614||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the morning at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the morning as covariate; and patient as a random effect.|
1618893|NCT02365636|2973271|Superiority||LSM difference from placebo|0.28||||0.177|2-Sided|95.0|-0.128|0.691||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the morning at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the morning as covariate; and patient as a random effect.|
1618894|NCT02365636|2973272|Superiority||LSM difference from placebo|0.27||||0.194|2-Sided|95.0|-0.14|0.688||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the evening as covariate; and patient as a random effect.|
1618895|NCT02365636|2973272|Superiority||LSM difference from placebo|0.32||||0.128|2-Sided|95.0|-0.093|0.735||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the average NRS pain scores recorded in the evening at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the average NRS pain scores recorded in the evening as covariate; and patient as a random effect.|
1618896|NCT02365636|2973273|Superiority||LSM difference from placebo|0.24||||0.245|2-Sided|95.0|-0.167|0.652||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.|
1618897|NCT02365636|2973273|Superiority||LSM difference from placebo|0.32||||0.13|2-Sided|95.0|-0.094|0.726||5% level of significance|mixed model for repeated measures|||The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.|
1618898|NCT02365584|2973283|Superiority|"The assumptions required for the analysis of covariance (ANCOVA) were to be tested as follows:~The equality of variances was to verified using the Levene’s test. If it was significant AUC values were to be properly transformed.~The linear relationship of AUC with the basal total score within treatment group was to be tested by a regression analysis.~The parallelism of the regression lines between groups and the slope non zero value with the appropriate F tests."|Adjusted LS Mean Difference|-11.0|Standard Error of the Mean|17.7|=|0|2-Sided|95.0|-47.0|25.0|||ANCOVA|||Analysis of covariance (ANCOVA), where the AUC was the dependent and the independent was the baseline ESAS total score.|
1618899|NCT02365233|2973303|Superiority||||||||||||||||||IRB withheld the data due to inadequate supporting documentation
1618900|NCT02364999|2973308|Other|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; >1 indicated an increase in PD/death in PF-06439535; <1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.918||||0.4726|2-Sided|95.0|0.729|1.157|||Log Rank|Stratified by smoking, sex and region.|||
1618901|NCT02364999|2973309|Other|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; >1 indicated an increase in PD/death in PF-06439535; <1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.931||||0.4492||95.0|0.777|1.116|||Log Rank|Stratified by smoking, sex and region.|||
1618902|NCT02364999|2973310|Other|Hazard ratio of PF-06439535 versus Bevacizumab-EU; a hazard ratio =1 indicated no difference in progressive disease(PD)/death between 2 reporting groups; >1 indicated an increase in PD/death in PF-06439535; <1 indicated an increase in PD/death in bevacizumab-EU.|Hazard Ratio (HR)|0.8||||0.1077|2-Sided|95.0|0.608|1.051|||Log Rank|Stratified by smoking, sex and region.|||
1618903|NCT02364999|2973313|Equivalence|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk ratio for confirmed response. Japan equivalence margins (95% CI in 0.729 to 1.371).|Risk Ratio (RR)|1.0146|||||2-Sided|95.0|0.8628|1.1933|||||PF-06439535 vs Bevacizumab-EU||
1618904|NCT02364999|2973313|Equivalence|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk ratio for confirmed response. US equivalence margins (90% CI in 0.73 to 1.37).|Risk Ratio (RR)|1.0146|||||2-Sided|90.0|0.8856|1.1625|||||PF-06439535 vs Bevacizumab-EU||
1618905|NCT02364999|2973313|Equivalence|Calculated based on 2-sided Miettinen and Nurminen method without strata for risk difference for confirmed response. EU equivalence margins (95% CI in -13% to 13%).|Risk Difference (RD)|0.6531|||||2-Sided|95.0|-6.608|7.9082|||||PF-06439535 vs Bevacizumab-EU||
1618906|NCT02364947|2973314|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.049|Standard Error of the Mean|0.034||0.1444|2-Sided|95.0|-0.116|0.017|||Mixed Models Analysis||||
1618907|NCT02364947|2973314|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.066|Standard Error of the Mean|0.031||0.0348|2-Sided|95.0|-0.127|-0.005|||Mixed Models Analysis||||
1618908|NCT02364947|2973315|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.049|Standard Error of the Mean|0.033||0.1374|2-Sided|95.0|-0.115|0.016|||Mixed Models Analysis|||Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|
1618909|NCT02364947|2973315|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.031||0.0234|2-Sided|95.0|-0.13|-0.009|||Mixed Models Analysis||||
1618910|NCT02364947|2973316|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.139|Standard Error of the Mean|0.044||0.0017|2-Sided|95.0|-0.226|-0.052|||Mixed Models Analysis||||
1618911|NCT02364947|2973316|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.168|Standard Error of the Mean|0.041|<|0.0001|2-Sided|95.0|-0.248|-0.088|||Mixed Models Analysis||||
1618912|NCT02364947|2973317|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.156|Standard Error of the Mean|0.039||0.0001|2-Sided|95.0|-0.232|-0.08|||Mixed Models Analysis||||
1618913|NCT02364947|2973317|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, logarithm scale baseline value, and logarithm scale baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.192|Standard Error of the Mean|0.036|<|0.0001|2-Sided|95.0|-0.262|-0.121|||Mixed Models Analysis||||
1618914|NCT02364947|2973318|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.55|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-0.77|-0.33|||Mixed Models Analysis||||
1618915|NCT02364947|2973318|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.7|-0.31|||Mixed Models Analysis||||
1618916|NCT02364947|2973319|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.67|-0.27|||Mixed Models Analysis||||
1618917|NCT02364947|2973319|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used. Baseline CGI-S value was used as baseline value in MMRM.|Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.69|-0.33|||Mixed Models Analysis||||
1618918|NCT02364947|2973320|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.51|-0.19|||Mixed Models Analysis||||
1618919|NCT02364947|2973320|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.33|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.48|-0.18|||Mixed Models Analysis||||
1619152|NCT02358668|2973786|Superiority or Other||Mean Difference (Net)|49.0||||0.69|2-Sided|95.0|-198.1|296.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1618920|NCT02364947|2973321|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.08||0.0001|2-Sided|95.0|-0.45|-0.15|||Mixed Models Analysis||||
1618921|NCT02364947|2973321|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.07||0.0002|2-Sided|95.0|-0.4|-0.13|||Mixed Models Analysis||||
1618922|NCT02364947|2973322|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|19.6||||0.0001|2-Sided|95.0|9.9|29.2|||Cochran-Mantel-Haenszel||||
1618923|NCT02364947|2973322|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|8.0||||0.0724|2-Sided|95.0|-0.7|16.7|||Cochran-Mantel-Haenszel||||
1618924|NCT02364947|2973323|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|17.9||||0.0001|2-Sided|95.0|8.9|26.9|||Cochran-Mantel-Haenszel||||
1618925|NCT02364947|2973323|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|15.2||||0.0002|2-Sided|95.0|7.1|23.3|||Cochran-Mantel-Haenszel||||
1618926|NCT02364947|2973324|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|12.8||||0.0013|2-Sided|95.0|4.6|21.0|||Cochran-Mantel-Haenszel||||
1618927|NCT02364947|2973324|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|13.6||||0.0003|2-Sided|95.0|6.2|20.9|||Cochran-Mantel-Haenszel||||
1618928|NCT02364947|2973325|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|11.1||||0.0016|2-Sided|95.0|3.8|18.3|||Cochran-Mantel-Haenszel||||
1618929|NCT02364947|2973325|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline value|Risk Difference (RD)|9.9||||0.0022|2-Sided|95.0|3.5|16.3|||Cochran-Mantel-Haenszel||||
1618930|NCT02364947|2973326|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|14.8||||0.001|2-Sided|95.0|5.8|23.9|||Cochran-Mantel-Haenszel||||
1618931|NCT02364947|2973326|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|11.0||||0.0079|2-Sided|95.0|2.9|19.1|||Cochran-Mantel-Haenszel||||
1618932|NCT02364947|2973327|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|14.3||||0.0002|2-Sided|95.0|6.4|22.2|||Cochran-Mantel-Haenszel||||
1618933|NCT02364947|2973327|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|17.8|||<|0.0001|2-Sided|95.0|10.5|25.1|||Cochran-Mantel-Haenszel||||
1618934|NCT02364947|2973328|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|20.6||||0.0001|2-Sided|95.0|10.4|30.8|||Cochran-Mantel-Haenszel||||
1618935|NCT02364947|2973328|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|18.0||||0.0002|2-Sided|95.0|8.8|27.2|||Cochran-Mantel-Haenszel||||
1618936|NCT02364947|2973329|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|15.7||||0.0007|2-Sided|95.0|6.5|25.0|||Cochran-Mantel-Haenszel||||
1618937|NCT02364947|2973329|Superiority or Other (legacy)|Cochran-Mantel-Haenszel test, stratified by sex and baseline DRL|Risk Difference (RD)|22.0|||<|0.0001|2-Sided|95.0|13.6|30.4|||Cochran-Mantel-Haenszel||||
1618938|NCT02364947|2973330|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-11.27|Standard Error of the Mean|3.11||0.0003|2-Sided|95.0|-17.37|-5.17|||Mixed Models Analysis||||
1618939|NCT02364947|2973330|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-11.15|Standard Error of the Mean|2.86||0.0001|2-Sided|95.0|-16.77|-5.53|||Mixed Models Analysis||||
1618940|NCT02364947|2973331|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-12.94|Standard Error of the Mean|2.95|<|0.0001|2-Sided|95.0|-18.72|-7.15|||Mixed Models Analysis||||
1618941|NCT02364947|2973331|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-12.47|Standard Error of the Mean|2.72|<|0.0001|2-Sided|95.0|-17.81|-7.13|||Mixed Models Analysis|||Change in total alcohol consumption (TAC) from baseline at Week 12|
1618942|NCT02364947|2973332|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.54|Standard Error of the Mean|0.98|<|0.0001|2-Sided|95.0|-6.46|-2.63|||Mixed Models Analysis||||
1618943|NCT02364947|2973332|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-3.92|Standard Error of the Mean|0.9|<|0.0001|2-Sided|95.0|-5.69|-2.16|||Mixed Models Analysis||||
1619841|NCT02340221|2975643|Superiority|||||||0.0002|||||||Cochran-Mantel-Haenszel||||
1618944|NCT02364947|2973333|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.18|Standard Error of the Mean|0.95||0.0001|2-Sided|95.0|-6.05|-2.32||Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.|Mixed Models Analysis||||
1618945|NCT02364947|2973333|Superiority or Other (legacy)|Mixed model for repeated measures (MMRM) with fixed effect of treatment, sex, time point, treatment-by-time point interaction, baseline value, and baseline value-by-time point interaction with an unstructured variance-covariance matrix structure was used.|Mean Difference (Final Values)|-4.34|Standard Error of the Mean|0.87||0.0001|2-Sided|95.0|-6.05|-2.62||Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.|Mixed Models Analysis||||
1618946|NCT02364700|2973343|Equivalence|Group means from baseline to discharge were compared to determine if 6-week and training on the Hand of Hope device elicited changes in outcome measures.|||||<|0.05|||||||Friedman Test||||
1618947|NCT02363959|2973376|Other|||||||1|||||||Fisher Exact||||
1618948|NCT02363959|2973377|Other|||||||1|||||||Fisher Exact||||
1618949|NCT02363959|2973378|Other|||||||1|||||||Fisher Exact||||
1618950|NCT02363959|2973379|Other|||||||1|||||||Fisher Exact||||
1618951|NCT02363959|2973380|Other|||||||0.39|||||||Fisher Exact||||
1618952|NCT02363959|2973381|Other||Odds Ratio (OR)|1.0||||1|2-Sided||||||Fisher Exact||||
1618953|NCT02363946|2973390|Other||beta estimate|1.163|Standard Error of the Mean|0.049|||2-Sided|95.0|1.081|1.245|||||Estimation of model: Parameter = alpha * Dose^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte ARC-MLP|R-square (r^2)=0.95
1618954|NCT02363946|2973390|Other||alpha estimate|12.347|Standard Error of the Mean|0.049|||2-Sided||||||||Estimation of model: Parameter = alpha * Dose^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte ARC-MLP|
1618955|NCT02363946|2973390|Other||beta estimate|1.179|Standard Error of the Mean|0.041|||2-Sided|95.0|1.11|1.249|||||Estimation of model: Parameter = alpha * Dose^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte AD00370|R-square (r^2)=0.96
1618956|NCT02363946|2973390|Other||alpha estimate|11.286|Standard Error of the Mean|0.058|||2-Sided||||||||Estimation of model: Parameter = alpha * Dose^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUCinf for Analyte AD00370|
1618957|NCT02363946|2973391|Other||beta estimate|1.147|Standard Error of the Mean|0.04|||2-Sided|95.0|1.08|1.215|||||Estimation of model: Parameter = alpha * Dose^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte ARC-MLP|R-square (r^2)=0.96
1618958|NCT02363946|2973391|Other||alpha estimate|12.133|Standard Error of the Mean|0.04|||2-Sided||||||||Estimation of model: Parameter = alpha * Dose^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte ARC-MLP|
1618959|NCT02363946|2973391|Other||beta estimate|1.181|Standard Error of the Mean|0.04|||2-Sided|95.0|1.112|1.249|||||Estimation of model: Parameter = alpha * Dose^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte AD00370|R-square (r^2)=0.96
1618960|NCT02363946|2973391|Other||alpha estimate|11.274|Standard Error of the Mean|0.057|||2-Sided||||||||Estimation of model: Parameter = alpha * Dose^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter AUC0-24 for Analyte AD00370|
1618961|NCT02363946|2973393|Other||beta estimate|1.103|Standard Error of the Mean|0.029|||2-Sided|95.0|1.054|1.153|||||Estimation of model: Parameter = alpha * Dose^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte ARC-MLP|R-square (r^2)=0.98
1618962|NCT02363946|2973393|Other||alpha estimate|9.824|Standard Error of the Mean|0.03|||2-Sided||||||||Estimation of model: Parameter = alpha * Dose^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte ARC-MLP|
1618963|NCT02363946|2973393|Other||beta estimate|1.173|Standard Error of the Mean|0.027|||2-Sided|95.0|1.128|1.218|||||Estimation of model: Parameter = alpha * Dose^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte AD00370|R-square (r^2)=0.98
1618964|NCT02363946|2973393|Other||alpha estimate|9.557|Standard Error of the Mean|0.037|||2-Sided||||||||Estimation of model: Parameter = alpha * Dose^beta. Determined from linear regression model: Log(Parameter) = log(Dose)|Dose-Proportionality of Pharmacokinetic Parameter Cmax for Analyte AD00370|
1618965|NCT02363803|2973404|Superiority|||||||0.03|||||||t-test, 2 sided|Paired t-test|||
1618966|NCT02363478|2973408|Superiority or Other|||||||0.05|||||||t-test, 2 sided|This statistical analysis applies to changes of amplitude of heartburn, regurgitation, chest pain and dysphagia between baseline and week 4.|||
1618967|NCT02363478|2973411|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|This statistical analysis applies to changes of amplitude of contractions, resting LES pressure and IRP between baseline and week 4.|||
1618968|NCT02362789|2973417|Superiority||Mean Difference (Net)|-18.3||||0.0055|2-Sided|95.0|-31.01|-5.59|||ANCOVA||||
1618969|NCT02362594|2973443|Superiority||Hazard Ratio (HR)|0.54|||<|0.0001|2-Sided|95.0|0.42|0.69||One-sided p-value based on log-rank test.|Regression, Cox|||Comparison of RFS time-to-event distribution between the 2 treatment arms (PD-L1-positive participants) was based on Cox regression model with treatment as a covariate stratified by stage (IIIA [>1 mm metastasis] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.|
1619267|NCT02357420|2974001|Superiority|||||||0.36|||||||Measures mixed effects model (MMRM)|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.|||
1618970|NCT02362594|2973444|Superiority||Hazard Ratio (HR)|0.57|||<|0.0001|2-Sided|98.4|0.43|0.74||One-sided p-value based on log-rank test.|Regression, Cox|||Comparison of RFS time-to-event distribution between the 2 treatment arms was based on Cox regression model with treatment as a covariate stratified by stage (IIIA [>1 mm metastasis] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.|
1618971|NCT02362503|2973450|Other||Mean Difference (Net)|0.617|||||2-Sided|95.0|0.082|1.151|||||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.||
1618972|NCT02362503|2973451|Other||Mean Difference (Net)|-0.4|||||2-Sided|95.0|-16.8|16.0|||||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.||
1618973|NCT02362503|2973457|Other||Mean Difference (Net)|35.67|||||2-Sided|95.0|24.16|44.25|||||Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for >1.0 log10 c/mL.||
1618974|NCT02362503|2973457|Other||Mean Difference (Net)|45.69|||||2-Sided|95.0|32.95|55.45|||||Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for >0.5 log10 c/mL.||
1618975|NCT02362503|2973458|Superiority||Mean Difference (Net)|-0.625|||<|0.0001|2-Sided|95.0|-0.81|-0.441||Hypothesis test:µfostemsavir=µPlacebo where µ is a common intercept.|ANCOVA||Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.||
1618976|NCT02362425|2973488|Superiority||Mean Difference (Final Values)|-12.5||||0.28|2-Sided|95.0|-38.9|13.9|||t-test, 2 sided||||
1618977|NCT02362425|2973489|Superiority||Mean Difference (Final Values)|0.6||||0.87|2-Sided|95.0|-7.4|8.5|||t-test, 2 sided||||
1618978|NCT02362425|2973490|Superiority||Mean Difference (Final Values)|2.5||||0.61|2-Sided|95.0|-10.3|15.2|||t-test, 2 sided||||
1618979|NCT02362425|2973491|Superiority||Mean Difference (Final Values)|0.2||||0.88|2-Sided|95.0|-2.8|3.3|||t-test, 2 sided||||
1618980|NCT02362425|2973492|Superiority||Mean Difference (Final Values)|0.4||||0.7|2-Sided|95.0|-1.8|2.7|||t-test, 2 sided||||
1618981|NCT02362425|2973493|Superiority||Mean Difference (Final Values)|0.5||||0.72|2-Sided|95.0|-2.5|3.5|||t-test, 2 sided||||
1618982|NCT02362425|2973494|Superiority||Mean Difference (Final Values)|-0.5||||0.76|2-Sided|95.0|-3.6|2.7|||t-test, 2 sided||||
1618983|NCT02362425|2973495|Superiority||Mean Difference (Final Values)|-2.1||||0.12|2-Sided|95.0|-5.0|0.6|||t-test, 2 sided||||
1618984|NCT02362425|2973496|Superiority||Mean Difference (Final Values)|10.0||||0.57|2-Sided|95.0|-59.5|39.5|||t-test, 2 sided||||
1618985|NCT02362425|2973497|Superiority||Mean Difference (Final Values)|-16.27||||0.39|2-Sided|95.0|-80.1|47.5|||t-test, 2 sided||||
1618986|NCT02362425|2973498|Superiority||Mean Difference (Final Values)|-6.4||||0.08|2-Sided|95.0|-13.7|1.0|||t-test, 2 sided||||
1618987|NCT02362425|2973499|Superiority||Mean Difference (Final Values)|-5.5||||0.15|2-Sided|95.0|-13.4|2.4|||t-test, 2 sided||||
1618988|NCT02362425|2973500|Superiority||Mean Difference (Final Values)|4.2||||0.09|2-Sided|95.0|-0.7|9.0|||t-test, 2 sided||||
1618989|NCT02362425|2973501|Superiority||Mean Difference (Final Values)|2.1||||0.09|2-Sided|95.0|-0.4|4.6|||t-test, 2 sided||||
1618990|NCT02362425|2973502|Superiority||Mean Difference (Final Values)|-0.2||||0.66|2-Sided|95.0|-1.3|0.8|||t-test, 2 sided||||
1618991|NCT02362425|2973503|Superiority||Mean Difference (Final Values)|0.1||||0.93|2-Sided|95.0|-2.6|2.4|||t-test, 2 sided||||
1618992|NCT02362425|2973504|Superiority||Mean Difference (Final Values)|1.1||||0.22|2-Sided|95.0|-0.8|3.0|||t-test, 2 sided||||
1618993|NCT02362425|2973505|Superiority||Mean Difference (Final Values)|-1.2||||0.31|2-Sided|95.0|-3.5|1.1|||t-test, 2 sided||||
1618994|NCT02362425|2973506|Superiority||Mean Difference (Final Values)|0.3||||0.69|2-Sided|95.0|-1.3|2.0|||t-test, 2 sided||||
1618995|NCT02362425|2973507|Superiority||Mean Difference (Final Values)|3.4||||0.09|2-Sided|95.0|-0.6|7.3|||t-test, 2 sided||||
1618996|NCT02362425|2973508|Superiority||Mean Difference (Final Values)|-1.1||||0.05|2-Sided|95.0|-2.1|0.0|||t-test, 2 sided||||
1618997|NCT02362425|2973509|Superiority||Mean Difference (Final Values)|-0.8||||0.25|2-Sided|95.0|-2.1|0.6|||t-test, 2 sided||||
1618998|NCT02362425|2973510|Superiority||Mean Difference (Final Values)|-0.5||||0.05|2-Sided|95.0|-1.1|0.0|||t-test, 2 sided||||
1618999|NCT02362425|2973511|Superiority||Mean Difference (Final Values)|-0.1||||0.62|2-Sided|95.0|-0.5|0.3|||t-test, 2 sided||||
1619000|NCT02362425|2973512|Superiority||Mean Difference (Final Values)|-1.5||||0.14|2-Sided|95.0|-3.6|0.7|||Regression, Linear||||
1619001|NCT02362425|2973513|Superiority||Mean Difference (Final Values)|23.9||||0.11|2-Sided|95.0|-5.5|53.4||Model controlled for six-month(pre-intervention) distance and treatment group. Investigated covariates: height|Regression, Linear|||In RYR1-RM myopathy patients, there will be no statistically significant difference in 6MWT (six minute walk test) total distance between NAC and placebo groups at month 12, after controlling for established a priori confounders.|
1619002|NCT02362425|2973514|Superiority|An a priori power calculation, with power at 80% and a two-sided α of 0·05, determined that n=76 participants (n=38 per group) would be required to detect a statistically significant post-intervention difference in plasma glutathione (GSH) concentration between NAC and placebo groups. After the primary endpoint was changed, re-evaluation of the sample size determined that a larger sample (total n=182) would be required. As per protocol, the study was completed at this time.|Mean Difference (Final Values)|0.1||||0.88|2-Sided|95.0|-1.4|1.6|||Regression, Linear|Model comparing 12 m corrected 15-F2t-isoprostane conc. controlling for pre-intervention value. Investigated covariates: smoking and drinking status.||Null Hypothesis: In RYR1-RM myopathy patients, there will be no statistically significant difference in corrected 15-F2t-isoprostane concentration and/or corrected 15=f2t-Isop:PGR2alpha ratio between NAC and placebo groups at month 12, after controlling for established a priori confounders.|
1619003|NCT02362412|2973517|Superiority or Other||Least Squares Mean Difference|0.0|||||2-Sided|95.0|-0.5|0.5|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.||
1619268|NCT02357264|2974024|Other|||||||0.162|||||||Fisher Exact||||
1619004|NCT02362412|2973518|Superiority or Other||Least Squares Mean Difference|0.0|||||2-Sided|95.0|-0.5|0.5|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.||
1619005|NCT02362412|2973520|Superiority or Other||Least Squares Mean Difference|0.1|||||2-Sided|95.0|-0.3|0.4|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.||
1619006|NCT02362412|2973521|Superiority or Other||Least Squares Mean Difference|0.1|||||2-Sided|95.0|-0.3|0.4|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.||
1619007|NCT02362412|2973522|Superiority or Other||Least Squares Mean Difference|0.1|||||2-Sided|95.0|-1.7|1.9|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.||
1619008|NCT02362412|2973523|Superiority or Other||Least Squares Mean Difference|-0.5|||||2-Sided|95.0|-3.4|2.3|||||Analysis of variance with treatment sequence, time point, and formulation as fixed effects and patient as a random effect using the data at Week 12 and Week 20 of the treatment period.||
1619009|NCT02362282|2973531|Superiority|||||||0.54|||||||t-test, 2 sided||||
1619010|NCT02361762|2973533|Other|||||||0.16|||||||ANCOVA|Repeated measures ANOVA compared group (Training/Waitlist) by time (Pre/Post) by condition (Go/Nogo) covarying the number of trials|||
1619011|NCT02361762|2973534|Other|||||||0.62|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)|||
1619012|NCT02361762|2973536|Other|||||||0.37|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)|||
1619013|NCT02361762|2973537|Other|||||||0.08|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)|||
1619014|NCT02361762|2973538|Other|||||||0.54|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)|||
1619015|NCT02361762|2973539|Other|||||||0.43|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)0.|||
1619016|NCT02361762|2973540|Other|||||||0.63|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)|||
1619017|NCT02361762|2973541|Other|||||||0.79||||||ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)|ANCOVA|Compared scores at post testing with baseline scores covaried.|||
1619018|NCT02361762|2973542|Other|||||||0.008|||||||ANOVA|Repeated measures ANOVA compared group (Training/Waitlist) by time (Pre/Post) by condition (Congruent/Incongruent) covarying the number of trials|||
1619019|NCT02361762|2973543|Other|||||||0.79|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)|||
1619020|NCT02361762|2973544|Other|||||||0.04|||||||ANCOVA|ANCOVA-of-change was used to compare the Training and Waitlist groups at post-testing while controlling for baseline (baseline was co-varied)|||
1619021|NCT02361216|2973560|Superiority or Other||Ratio of clearance|0.28|||<|0.001|2-Sided|95.0|0.24|0.32||Negative binominal regression with log baseline count as offset variable and treatment group, anatomical location stratum and pooled site as factors.|Cochran-Mantel-Haenszel|||The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1619022|NCT02361216|2973561|Superiority or Other||Ratio of clearance rates|6.53|||<|0.001|2-Sided|95.0|4.04|10.5|||Mantel Haenszel|||The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The pre-specified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1619023|NCT02361216|2973562|Superiority||Ratio of clearance rates|6.81|||<|0.001|2-Sided|95.0|4.16|11.1|||Cochran-Mantel-Haenszel||Mantel-Haenszel estimate (0.027% relative to vehicle), adjusted for pooled sites|The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.|
1619024|NCT02361216|2973563|Superiority or Other||Ratio of clearance rates|6.29|||<|0.001|2-Sided|95.0|2.82|14.0|||Cochran-Mantel-Haenszel|||AKclear100 at Week 8: full analysis set. The null hypothesis was that there is no difference at Week 8 in AKclear100 rates between ingenol mebutate gel 0.027% and vehicle gel. This hypothesis was tested against the 2-sided alternative of a difference between the 2 treatment groups.|
1619025|NCT02360995|2973564|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1619026|NCT02360995|2973565|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1619027|NCT02360995|2973566|Superiority or Other|||||||0.533|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1619028|NCT02360995|2973567|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1619029|NCT02360995|2973568|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1619030|NCT02360995|2973569|Superiority or Other|||||||0.652|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1619100|NCT02358668|2973759|Superiority or Other||Mean Difference (Net)|0.42||||0.37|2-Sided|95.0|-0.51|1.36||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619269|NCT02356198|2974107|Superiority|||||||0.212|||||||Fisher Exact||||
1619270|NCT02356198|2974108|Superiority|||||||0.454|||||||Chi-squared||||
1619031|NCT02360488|2973577|Non-Inferiority|The trial aimed to establish comparable efficacy based upon a non-inferiority margin of 30% of the change in Fugl-Meyer score in the In-Clinic group. Under these assumptions at alpha=0.05 and assuming SD=3.8 points, 124 subjects would need to be enrolled to provide 85% power; this sample was pursued independent of subject dropouts.|Mean Difference (Net)|0.06||||0.96|2-Sided|95.0|-2.14|2.26|||Regression, Linear|The model was adjusted for study site, age, time post-stroke, stroke subtype, and baseline Fugl-Meyer score.|||
1619032|NCT02360293|2973595|Superiority||Slope|-0.345|Standard Error of the Mean|0.267|||2-Sided|95.0|-1.044|0.353|||||Estimate generated through ANCOVA predicting “Pain In Past Week” as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline..|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.|
1619033|NCT02360293|2973596|Superiority||Slope|-1.162|Standard Error of the Mean|0.69|||2-Sided|95.0|-2.969|0.646|||||Generated through ANCOVA predicting PHQ-8 Score as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.|
1619034|NCT02360293|2973597|Superiority||Slope|-5.02|Standard Error of the Mean|56.7|||2-Sided|95.0|-15.85|5.81|||||Generated through ANCOVA predicting Weight as a function of the interaction of arm and follow-up time. Estimate represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|The estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA.|
1619035|NCT02360293|2973598|Superiority||Slope|1.88|Standard Error of the Mean|46.2|||2-Sided|95.0|-119.0|122.7|||||Generated through ANCOVA predicting Active Minutes as a function of arm and f/u time, adjusted for Sex, Baseline PA Goal (AM), and type of Smart Phone. Represents the contrast between SS+Coaching, 12 mos. - Baseline vs. SS alone, 12 mos. - Baseline.|Estimated marginal means/least squares means are derived from a linear mixed model/rmANOVA/rmANCOVA, adjusted for baseline AM goal, Type of Smart Phone, and Sex.|
1619036|NCT02360228|2973606|Other|||||||0.11|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham groups using a one way ANOVA. Degrees of freedom: df=19||"The null hypothesis was that there is no difference between the changes in the BACS score from baseline to 5 days between the groups:~H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)"|
1619037|NCT02360228|2973607|Other|||||||0.37|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham using a one way ANOVA. Degrees of freedom: df=19||The null hypothesis was that there is no difference between the changes in the PANSS score from day 5 to baseline. H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)|
1619038|NCT02360228|2973609|Other|||||||0.47|||||||ANOVA|Difference from day 5 to baseline was compared between the tACS, tDCS, and sham groups using a one way ANOVA. Degrees of freedom: df=19||The null hypothesis was that there is no difference between the changes in the AHRS score from baseline to 5 days between the groups.H0: μ1=μ2=μ3 μ1: mean(difference 5 days-baseline) for tACS group (n=8) μ2: mean(difference 5 days-baseline) for tDCS group (n=7) μ3: mean(difference 5 days-baseline) for sham group (n=7)|
1619039|NCT02360215|2973614|Superiority|||||||0.47||||||Two-sided p-value = 0.05|Chi-squared||||
1619040|NCT02360215|2973615|Superiority||Hazard Ratio (HR)|1.14||||0.242|2-Sided|95.0|0.91|1.43||Two-sided significance level = 0.05|Log Rank||Reference level = WBRT + Memantin||
1619041|NCT02360215|2973616|Superiority||Hazard Ratio (HR)|1.2||||0.076|2-Sided|95.0|0.98|1.47||Two-sided significance level = 0.05|Log Rank||Reference level = WBRT + Memantine||
1619042|NCT02360215|2973617|Other|||||||0.92||||||Significance level = 0.05|t-test, 2 sided||||
1619043|NCT02360215|2973618|Superiority|||||||0.91||||||Significance level = 0.05|t-test, 2 sided||||
1619044|NCT02360215|2973619|Superiority|||||||0.64||||||Significance level = 0.05|t-test, 2 sided||||
1619045|NCT02360215|2973620|Superiority|||||||0.18||||||Significance level = 0.05|t-test, 2 sided||||
1619046|NCT02360215|2973621|Superiority|||||||0.66||||||Significance level = 0.05|t-test, 2 sided||||
1619047|NCT02360215|2973622|Superiority|||||||0.95||||||Significance level = 0.05|t-test, 2 sided||||
1619048|NCT02360215|2973624|Superiority|||||||0.86||||||Significance level = 0.05|t-test, 2 sided||||
1619049|NCT02360215|2973625|Superiority|||||||0.0078|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Age (> 61 years vs. <= 61 years) is reported here.|
1619050|NCT02360215|2973625|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline neurologic factor is reported here.|
1619051|NCT02360215|2973625|Superiority||||||<|0.8877|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Neurologic Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.|
1619101|NCT02358668|2973759|Superiority or Other||Mean Difference (Net)|-0.65||||0.18|2-Sided|95.0|-1.62|0.31||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619052|NCT02360215|2973626|Superiority|||||||0.0032|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Prior radiotherapy (yes vs. no) is reported here.|
1619053|NCT02360215|2973626|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline cognitive factor score is reported here.|
1619054|NCT02360215|2973626|Superiority||||||<|0.1964|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Cognitive Factor Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.|
1619055|NCT02360215|2973627|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Interference Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline interference score is reported here.|
1619056|NCT02360215|2973627|Superiority||||||<|0.9118|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Interference Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.|
1619057|NCT02360215|2973628|Superiority|||||||0.083|||||||Mixed Models Analysis|||A two-sample t-test with a 2-sided type I error of 0.05 provides >90% statistical power to detect a medium effect size of 0.5 for a comparison of the change from baseline to 6 months from the start of treatment. The comparison at six months was tested within a mixed effects model with covariates age, RPA class, prior radiosurgery, prior surgical resection, baseline score, treatment arm, and time was used.|
1619058|NCT02360215|2973628|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Symptom Severity score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline symptom severity is reported here.|
1619059|NCT02360215|2973628|Superiority||||||<|0.57|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with MDASI-BT Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.|
1619060|NCT02360215|2973629|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline composite score is reported here.|
1619061|NCT02360215|2973629|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Age (> 61 years vs. <= 61 years) is reported here.|
1619062|NCT02360215|2973629|Superiority||||||<|0.2552|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with the neurocognitive composite score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.|
1619063|NCT02360215|2973630|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Age (> 61 years vs. <= 61 years) is reported here. is reported here.|
1619271|NCT02356198|2974109|Superiority|||||||0.85|||||||Wilcoxon (Mann-Whitney)||||
1619272|NCT02356198|2974110|Superiority|||||||0.102|||||||Wilcoxon (Mann-Whitney)||||
1619064|NCT02360215|2973630|Superiority||||||<|0.9749|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.|
1619065|NCT02360215|2973630|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with COWA (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline COWA is reported here.|
1619066|NCT02360215|2973631|Superiority||||||<|0.0001|||||||Regression, Cox|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline TMT Part B is reported here.|
1619067|NCT02360215|2973631|Superiority||||||<|0.0024|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Age (> 61 years vs. <= 61 years) is reported here.|
1619068|NCT02360215|2973631|Superiority||||||<|0.9226|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part B (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.|
1619069|NCT02360215|2973632|Superiority||||||<|0.0001|||||||McNemar|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline TMT Part A is reported here.|
1619070|NCT02360215|2973632|Superiority||||||<|0.0005|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Age (> 61 years vs. <= 61 years) is reported here.|
1619071|NCT02360215|2973632|Superiority||||||<|0.5988|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with TMT Part A (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.|
1619072|NCT02360215|2973633|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Delayed Recognition is reported here.|
1619073|NCT02360215|2973633|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Age (> 61 years vs. <= 61 years) is reported here.|
1619074|NCT02360215|2973633|Superiority||||||<|0.0993|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recognition Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.|
1619075|NCT02360215|2973634|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Delayed Recall is reported here.|
1619102|NCT02358668|2973760|Superiority or Other||Mean Difference (Net)|0.39||||0.37|2-Sided|95.0|-0.46|1.24||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619076|NCT02360215|2973634|Superiority||||||<|0.0067|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Age (> 61 years vs. <= 61 years) is reported here.|
1619077|NCT02360215|2973634|Superiority||||||<|0.2656|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Delayed Recall Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.|
1619078|NCT02360215|2973635|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Baseline Total Recall is reported here.|
1619079|NCT02360215|2973635|Superiority||||||<|0.0048|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Age (>61 year vs. <= 61 years) is reported here.|
1619080|NCT02360215|2973635|Superiority||||||<|0.0586|||||||Mixed Models Analysis|Each explanatory variable is reported separately. (Time and intercept estimates are not shown.)||A mixed effects model was run with HVLT-R Symptom Score (baseline, 2, 4, 6, and 12 months) as the outcome of interest. Age, RPA class, prior radiosurgery, prior surgical resection were the covariates considered in each model along with interaction terms treatment*time, time*time, time*time*time and remained if p<0.05. Baseline score, treatment arm, and time were forced into the model. Treatment Arm (WBRT+Memantine vs. HA-WBRT Memantine) is reported here.|
1619081|NCT02360215|2973636|Superiority||Hazard Ratio (HR)|0.76||||0.029|2-Sided|95.0|0.59|0.96|||Gray's test|||Null hypothesis: the addition of HA-WBRT as compared to WBRT will increase time to neurocognitive failure from 53.8% in the WBRT arm to 42.8% in the HA-WBRT arm at 6 months. Treating death as a competing risk and using a Gray’s test with two-sided α=0.05 to test for statistically significant difference in the distribution of neurocognitive failure times, it was calculated that 230 events over both arms would provide 90% statistical power.|
1619082|NCT02359890|2973674|Superiority or Other||Percentage of patient with acute success|96.2|||||2-Sided|95.0|92.0|98.6|||||The 2-sided 95% confidence interval is derived using the exact Clopper–Pearson interval||
1619083|NCT02359890|2973676|Superiority or Other||Percentage of participants with events|2.6|||||2-Sided|95.0|0.7|6.5|||||The 2-sided 95% confidence interval is derived using the exact Clopper–Pearson interval.||
1619084|NCT02359435|2973691|Superiority or Other||Hazard Ratio (HR)|0.016|||<|0.05|2-Sided||||||Chi-squared||||
1619085|NCT02359110|2973695|Superiority|||||||0.88|||||||t-test, 2 sided||||
1619086|NCT02359110|2973696|Superiority||Mean Difference (Final Values)|1.7||||0.8|2-Sided|95.0|-11.9|15.3|||Mixed Models Analysis|||Hour 6 Analysis|
1619087|NCT02359110|2973696|Superiority||Mean Difference (Final Values)|3.8||||0.52|2-Sided|95.0|-8.1|15.8|||Mixed Models Analysis|||Hour 2 Analysis|
1619088|NCT02359110|2973697|Superiority||Mean Difference (Final Values)|0.6||||0.59|2-Sided|95.0|-1.6|2.8|||Mixed Models Analysis|||Hour 8 Analysis|
1619089|NCT02359110|2973697|Superiority||Mean Difference (Final Values)|-0.4||||0.64|2-Sided|95.0|-2.2|1.3|||Mixed Models Analysis|||Hour 6 Analysis|
1619090|NCT02359110|2973697|Superiority||Mean Difference (Final Values)|-0.1||||0.94|2-Sided|95.0|-1.6|1.5|||Mixed Models Analysis|||Hour 4 Analysis|
1619091|NCT02359110|2973697|Superiority||Mean Difference (Final Values)|0.1||||0.89|2-Sided|95.0|-1.2|1.3|||Mixed Models Analysis|||Hour 2 Analysis|
1619092|NCT02358668|2973755|Superiority or Other|||||||0.89||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided||||
1619093|NCT02358668|2973755|Superiority or Other|||||||0.61||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided||||
1619094|NCT02358668|2973756|Superiority or Other|||||||0.48||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided||||
1619095|NCT02358668|2973756|Superiority or Other|||||||0.41||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided||||
1619096|NCT02358668|2973757|Superiority or Other|||||||0.22||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided||||
1619097|NCT02358668|2973757|Superiority or Other|||||||0.29||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided||||
1619098|NCT02358668|2973758|Superiority or Other||Mean Difference (Net)|0.43||||0.69|2-Sided|95.0|-1.71|2.58||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619099|NCT02358668|2973758|Superiority or Other||Mean Difference (Net)|-2.14||||0.06|2-Sided|95.0|-4.36|0.09||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619273|NCT02356198|2974111|Superiority|||||||0.007|||||||t-test, 2 sided||||
1619842|NCT02340221|2975644|Superiority||Hazard Ratio (HR)|0.7||||0.0037|2-Sided|95.0|0.56|0.89|||Log Rank||||
1619103|NCT02358668|2973760|Superiority or Other||Mean Difference (Net)|-0.62||||0.17|2-Sided|95.0|-1.5|0.26||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619104|NCT02358668|2973761|Superiority or Other||Mean Difference (Net)|0.22||||0.64|2-Sided|95.0|-0.73|1.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619105|NCT02358668|2973761|Superiority or Other||Mean Difference (Net)|-0.48||||0.34|2-Sided|95.0|-1.46|0.5||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619106|NCT02358668|2973762|Superiority or Other||Mean Difference (Net)|0.01||||0.87|2-Sided|95.0|-0.13|0.15||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619107|NCT02358668|2973762|Superiority or Other||Mean Difference (Net)|-0.16||||0.03|2-Sided|95.0|-0.31|-0.02||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619108|NCT02358668|2973763|Superiority or Other||Mean Difference (Net)|0.03||||0.46|2-Sided|95.0|-0.05|0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619109|NCT02358668|2973763|Superiority or Other||Mean Difference (Net)|-0.07||||0.06|2-Sided|95.0|-0.15|0.0||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619110|NCT02358668|2973764|Superiority or Other||Mean Difference (Net)|0.03||||0.46|2-Sided|95.0|-0.05|0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619111|NCT02358668|2973764|Superiority or Other||Mean Difference (Net)|-0.07||||0.06|2-Sided|95.0|-0.15|0.0||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619112|NCT02358668|2973765|Superiority or Other||Mean Difference (Net)|0.01||||0.73|2-Sided|95.0|-0.06|0.09||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619113|NCT02358668|2973765|Superiority or Other||Mean Difference (Net)|-0.05||||0.18|2-Sided|95.0|-0.13|0.02||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619114|NCT02358668|2973766|Superiority or Other||Mean Difference (Net)|-0.09||||0.63|2-Sided|95.0|-0.48|0.29||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619115|NCT02358668|2973766|Superiority or Other||Mean Difference (Net)|-0.42||||0.03|2-Sided|95.0|-0.81|-0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619116|NCT02358668|2973767|Superiority or Other||Mean Difference (Net)|-0.08||||0.54|2-Sided|95.0|-0.35|0.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619117|NCT02358668|2973767|Superiority or Other||Mean Difference (Net)|-0.39||||0.01|2-Sided|95.0|-0.67|-0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619118|NCT02358668|2973768|Superiority or Other||Mean Difference (Net)|-0.17||||0.1|2-Sided|95.0|-0.38|0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619119|NCT02358668|2973768|Superiority or Other||Mean Difference (Net)|-0.19||||0.08|2-Sided|95.0|-0.4|0.03||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619120|NCT02358668|2973769|Superiority or Other||Mean Difference (Net)|-0.08||||0.41|2-Sided|95.0|-0.28|0.11||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619121|NCT02358668|2973769|Superiority or Other||Mean Difference (Net)|-0.27||||0.01|2-Sided|95.0|-0.48|-0.07||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619122|NCT02358668|2973770|Superiority or Other||Mean Difference (Net)|-0.09||||0.38|2-Sided|95.0|-0.3|0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619123|NCT02358668|2973770|Superiority or Other||Mean Difference (Net)|-0.31|||<|0.01|2-Sided|95.0|-0.52|-0.1||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619124|NCT02358668|2973771|Superiority or Other||Mean Difference (Net)|-0.15||||0.14|2-Sided|95.0|-0.34|0.05||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619151|NCT02358668|2973784|Superiority or Other||Mean Difference (Net)|-2.2||||0.57|2-Sided|95.0|-9.8|5.5||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619125|NCT02358668|2973771|Superiority or Other||Mean Difference (Net)|-0.32|||<|0.01|2-Sided|95.0|-0.52|-0.12||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619126|NCT02358668|2973772|Superiority or Other||Mean Difference (Net)|-0.17||||0.57|2-Sided|95.0|-0.75|0.42||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619127|NCT02358668|2973772|Superiority or Other||Mean Difference (Net)|-0.74||||0.02|2-Sided|95.0|-1.35|-0.14||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619128|NCT02358668|2973773|Superiority or Other||Mean Difference (Net)|-0.17||||0.42|2-Sided|95.0|-0.57|0.24||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619129|NCT02358668|2973773|Superiority or Other||Mean Difference (Net)|-0.59||||0.01|2-Sided|95.0|-1.01|-0.18||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619130|NCT02358668|2973774|Superiority or Other||Mean Difference (Net)|-0.14||||0.13|2-Sided|95.0|-0.32|0.04||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619131|NCT02358668|2973774|Superiority or Other||Mean Difference (Net)|-0.3|||<|0.01|2-Sided|95.0|-0.48|-0.11||The p-value of treatment effects (reference to placebo) were obtained by mixed effect model analysis comparing the outcome values adjusted with repeated measures, ages and gender.|Mixed Models Analysis||||
1619132|NCT02358668|2973775|Superiority or Other|||||||0.3||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided||||
1619133|NCT02358668|2973775|Superiority or Other|||||||0.67||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided||||
1619134|NCT02358668|2973776|Superiority or Other|||||||0.26||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided||||
1619135|NCT02358668|2973776|Superiority or Other|||||||0.68||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided||||
1619136|NCT02358668|2973777|Superiority or Other|||||||0.82||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided||||
1619137|NCT02358668|2973777|Superiority or Other|||||||0.09||||||The univariate p-value of treatment group was obtained by t-tests comparing the changes to that of placebo group|t-test, 2 sided||||
1619138|NCT02358668|2973778|Superiority or Other||Mean Difference (Net)|0.4||||0.36|2-Sided|95.0|-0.4|1.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619139|NCT02358668|2973778|Superiority or Other||Mean Difference (Net)|-0.4||||0.36|2-Sided|95.0|-1.2|0.5||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619140|NCT02358668|2973779|Superiority or Other||Mean Difference (Net)|0.015||||0.4|2-Sided|95.0|-0.021|0.051||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619141|NCT02358668|2973779|Superiority or Other||Mean Difference (Net)|0.002||||0.93|2-Sided|95.0|-0.035|0.038||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619142|NCT02358668|2973780|Superiority or Other||Mean Difference (Net)|1.13||||0.24|2-Sided|95.0|-0.75|3.05||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619143|NCT02358668|2973780|Superiority or Other||Mean Difference (Net)|0.62||||0.52|2-Sided|95.0|-1.32|2.57||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619144|NCT02358668|2973781|Superiority or Other||Mean Difference (Net)|-0.22||||0.3|2-Sided|95.0|-0.63|0.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619145|NCT02358668|2973781|Superiority or Other||Mean Difference (Net)|0.03||||0.9|2-Sided|95.0|-0.39|0.44||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619146|NCT02358668|2973782|Superiority or Other||Mean Difference (Net)|-0.1||||0.86|2-Sided|95.0|-1.7|1.4||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619147|NCT02358668|2973782|Superiority or Other||Mean Difference (Net)|-1.7||||0.03|2-Sided|95.0|-3.2|-0.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619148|NCT02358668|2973783|Superiority or Other||Mean Difference (Net)|0.5||||0.68|2-Sided|95.0|-2.0|3.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619149|NCT02358668|2973783|Superiority or Other||Mean Difference (Net)|-0.8||||0.54|2-Sided|95.0|-3.4|1.8||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619150|NCT02358668|2973784|Superiority or Other||Mean Difference (Net)|1.0||||0.79|2-Sided|95.0|-6.6|8.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619153|NCT02358668|2973786|Superiority or Other||Mean Difference (Net)|-120.2||||0.37|2-Sided|95.0|-385.3|144.9||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619154|NCT02358668|2973787|Superiority or Other||Mean Difference (Net)|60.1||||0.29|2-Sided|95.0|-52.5|172.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619155|NCT02358668|2973787|Superiority or Other||Mean Difference (Net)|15.0||||0.79|2-Sided|95.0|-99.6|129.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619156|NCT02358668|2973788|Superiority or Other||Mean Difference (Net)|323.9||||0.68|2-Sided|95.0|-1269.0|1916.6||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619157|NCT02358668|2973788|Superiority or Other||Mean Difference (Net)|-980.0||||0.23|2-Sided|95.0|-2604.0|643.8||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619158|NCT02358668|2973789|Superiority or Other||Mean Difference (Net)|40.0||||0.34|2-Sided|95.0|-43.9|123.9||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619159|NCT02358668|2973789|Superiority or Other||Mean Difference (Net)|-13.6||||0.75|2-Sided|95.0|-99.6|72.3||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619160|NCT02358668|2973790|Superiority or Other||Mean Difference (Net)|-0.92||||0.86|2-Sided|95.0|-11.1|9.27||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619161|NCT02358668|2973790|Superiority or Other||Mean Difference (Net)|1.14||||0.83|2-Sided|95.0|-9.17|11.45||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619162|NCT02358668|2973791|Superiority or Other||Mean Difference (Net)|-0.04||||0.48|2-Sided|95.0|-0.16|0.08||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619163|NCT02358668|2973791|Superiority or Other||Mean Difference (Net)|-0.01||||0.83|2-Sided|95.0|-0.13|0.1||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619164|NCT02358668|2973792|Superiority or Other||Mean Difference (Net)|-1.75||||0.24|2-Sided|95.0|-4.72|1.21||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619165|NCT02358668|2973792|Superiority or Other||Mean Difference (Net)|-1.19||||0.46|2-Sided|95.0|-4.43|2.05||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619166|NCT02358668|2973793|Superiority or Other||Mean Difference (Net)|-0.09||||0.41|2-Sided|95.0|-0.3|0.12||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619167|NCT02358668|2973793|Superiority or Other||Mean Difference (Net)|-0.05||||0.64|2-Sided|95.0|-0.29|0.18||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619168|NCT02358668|2973794|Superiority or Other||Mean Difference (Net)|-1.34||||0.15|2-Sided|95.0|-3.18|0.51||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619169|NCT02358668|2973794|Superiority or Other||Mean Difference (Net)|-0.84||||0.41|2-Sided|95.0|-2.88|1.21||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619170|NCT02358668|2973795|Superiority or Other||Mean Difference (Net)|0.11||||0.49|2-Sided|95.0|-0.21|0.44||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619171|NCT02358668|2973795|Superiority or Other||Mean Difference (Net)|0.15||||0.4|2-Sided|95.0|-0.2|0.51||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619172|NCT02358668|2973796|Superiority or Other||Mean Difference (Net)|0.01||||0.97|2-Sided|95.0|-0.52|0.55||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619173|NCT02358668|2973796|Superiority or Other||Mean Difference (Net)|0.15||||0.62|2-Sided|95.0|-0.44|0.73||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619174|NCT02358668|2973797|Superiority or Other||Mean Difference (Net)|-0.14||||0.59|2-Sided|95.0|-0.66|0.38||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619175|NCT02358668|2973797|Superiority or Other||Mean Difference (Net)|0.05||||0.86|2-Sided|95.0|-0.5|0.59||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619176|NCT02358668|2973798|Superiority or Other||Mean Difference (Net)|0.07||||0.9|2-Sided|95.0|-1.03|1.18||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619177|NCT02358668|2973798|Superiority or Other||Mean Difference (Net)|0.25||||0.66|2-Sided|95.0|-0.91|1.42||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619178|NCT02358668|2973799|Superiority or Other||Mean Difference (Net)|-1.57||||0.72|2-Sided|95.0|-10.3|7.11||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619179|NCT02358668|2973799|Superiority or Other||Mean Difference (Net)|2.46||||0.57|2-Sided|95.0|-6.28|11.2||The p-value of treatment effects relative to placebo was obtained by ANCOVA analysis comparing the outcome values adjusted for age, gender and baseline measurements.|ANCOVA||||
1619180|NCT02358343|2973807|Superiority||Mean Difference (Final Values)|0.25|||||2-Sided|95.0|-0.25|0.75|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).||
1619181|NCT02358343|2973808|Superiority||Mean Difference (Final Values)|-0.1|||||2-Sided|95.0|-0.54|0.34|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).||
1619182|NCT02358343|2973809|Superiority||Risk Ratio (RR)|0.78|||||2-Sided|95.0|0.55|1.1|||||The mean difference estimate is from a negative binomial model adjusted for clinical site. It is the rate of sessions skipped/shortened in the Drug group (numerator) compared to CBT (denominator).||
1619183|NCT02358343|2973810|Superiority||Mean Difference (Final Values)|0.1|||||2-Sided|95.0|-0.5|0.7|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).||
1619184|NCT02358343|2973812|Superiority||Mean Difference (Final Values)|-0.01|||||2-Sided|95.0|-0.5|0.5|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).||
1619185|NCT02358343|2973813|Superiority||Mean Difference (Final Values)|2.6|||||2-Sided|95.0|0.1|5.1|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).||
1619186|NCT02358343|2973814|Superiority||Mean Difference (Final Values)|0.6|||||2-Sided|95.0|-0.2|1.4|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).||
1619187|NCT02358343|2973815|Superiority||Mean Difference (Final Values)|10.2|||||2-Sided|95.0|1.3|19.0|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).||
1619188|NCT02358343|2973816|Superiority||Mean Difference (Final Values)|-3.1|||||2-Sided|95.0|-6.2|-0.1|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).||
1619189|NCT02358343|2973817|Superiority||Mean Difference (Final Values)|-1.2|||||2-Sided|95.0|-3.1|0.8|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).||
1619190|NCT02358343|2973818|Superiority||Mean Difference (Final Values)|-3.7|||||2-Sided|95.0|-7.4|-0.02|||||The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120).||
1619191|NCT02358343|2973819|Superiority|||||||0.96||||||a priori threshold for significance is 0.05.|Likelihood Ratio Test|Likelihood Ratio Test from logistic regression analysis adjusting for clinical site.|||
1619192|NCT02358343|2973820|Superiority||Mean Difference (Final Values)|-1.84||||0.035|2-Sided|95.0|-3.54|-0.13||a priori threshold for significance is 0.05.|Wald Test|The Wald test is for the week 12 comparative treatment effect from a longitudinal model of QIDS-C adjusting for clinical site.|The week 12 mean difference estimated from the longitudinal model is the difference between antidepressant drug therapy (drug) and the cognitive behavioral therapy (CBT) at 12 weeks, (drug - CBT).|All participants randomized to treatment (N=120) were included in the pre-specified longitudinal model of QIDS-C used to estimate comparative treatment effect at 12 weeks (primary outcome). The model adjustment for clinical site and included baseline, 6 week and 12 week QIDS-C scores. Week 0 (baseline) and week 6 measurements are not pre-specified primary or secondary outcomes. The Observational Cohort arm was not included in the analysis.|
1619193|NCT02358343|2973821|Superiority|||||||0.77||||||a priori threshold for significance is 0.05.|Likelihood Ratio Test|Likelihood ratio test obtained from logistic regression analysis adjusting for site|||
1619194|NCT02358044|2973829|Non-Inferiority or Equivalence|The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.|Adjusted Difference in Percentage|8.8|||||2-Sided|95.0|3.3|15.7||||||Analyses of the percentage of participants achieving SVR24 was conducted using the Miettinen & Nurminen (M&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided.|
1619195|NCT02358044|2973830|Superiority or Other||Difference in Percentage|-13.5|||<|0.001|2-Sided|95.0|-20.8|-7.9||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Hemoglobin <10 g/dL:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."|
1619433|NCT02349451|2974702|Superiority||Least squares mean difference|-0.13|||<|0.479|2-Sided|95.0|-0.48|0.23||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA||||
1619196|NCT02358044|2973830|Superiority or Other||Difference in Percentage|-12.7|||<|0.001|2-Sided|95.0|-19.7|-8.0||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Neutrophil count <0.75 x 10^9/L:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."|
1619197|NCT02358044|2973830|Superiority or Other||Difference in Percentage|-0.8|||<|0.312|2-Sided|95.0|-4.4|2.1||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"DC due to drug-related AE:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."|
1619198|NCT02358044|2973830|Superiority or Other||Difference in Percentage|-2.4|||<|0.078|2-Sided|95.0|-6.8|0.6||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Serious drug-related AEs:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."|
1619199|NCT02358044|2973830|Superiority or Other||Difference in Percentage|-27.0|||<|0.001|2-Sided|95.0|-35.5|-19.6||% of participants with ≥1 Tier 1 event = total number participants with ≥1 Tier 1 event ÷ total number ASaT participants within each treatment arm. M&N method used to calculate a 2-sided 95% CI for the treatment difference and corresponding p-value.|Miettinen & Nurminen Method|||"Total Tier 1 AEs:~If, and only if the primary efficacy null hypothesis was rejected, the Tier 1 safety superiority hypothesis was tested at the 2-sided 5% alpha level. The safety superiority hypothesis was that the percentage of grazoprevir+elbasvir participants with ≥1 Tier 1 event is lower than the percentage of SOF+PR participants with ≥1 Tier 1 event."|
1619200|NCT02358044|2973832|Superiority or Other||Difference in Percentage|-41.7|||||2-Sided|95.0|-51.1|-31.9||||||The percentage of participants with an event were assessed via point estimates with 95% CIs provided for between-group comparisons.|
1619201|NCT02358044|2973833|Superiority or Other||Adjusted Difference in Percentage|8.8||||0.001|2-Sided|95.0|3.6|15.3|||Miettinen & Nurminen Method|The lower bound of 95% CIs was compared to zero to evaluate superiority. The M=F approach was used to handle missing values.||"Secondary Analysis Approach: Superiority~Analyses of the percentage of participants achieving SVR12 was conducted using the M&N method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir +elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% CIs and p-values were provided."|
1619202|NCT02358044|2973833|Non-Inferiority or Equivalence|The lower bound of 95% CIs was compared to pre-specified non-inferiority margin, -10% to evaluate non-inferiority. The Missing=Failure (M=F) approach was used to handle missing values.|Adjusted Difference in Percentage|8.8|||<|0.001|2-Sided|95.0|3.6|15.3|||Miettinen & Nurminen Method|||"Primary Analysis Approach: Non-Inferiority~Analyses of the percentage of participants achieving SVR12 was conducted using the Miettinen & Nurminen (M&N) method. The analysis was adjusted for genotype (1a vs. non-1a) and fibrosis stage (cirrhotic vs. non-cirrhotic). The adjusted differences (grazoprevir+elbasvir arm minus SOF+PR arm) in percentages along with the corresponding 95% confidence intervals (CIs) and p-values were provided."|
1619203|NCT02358031|2973836|Other||Hazard Ratio (HR)|1.26||||0.8751|2-Sided|95.0|0.85|1.88||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H&N35 Swallowing Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).|
1619204|NCT02358031|2973837|Other||Hazard Ratio (HR)|0.8||||0.1501|2-Sided|95.0|0.53|1.21||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H&N35 Pain Score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).|
1619205|NCT02358031|2973838|Other||Hazard Ratio (HR)|1.38||||0.953|2-Sided|95.0|0.95|2.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).|
1619206|NCT02358031|2973839|Other||Difference in LS Means|0.24||||0.893|2-Sided|95.0|-3.34|3.82||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|constrained Longitudinal Data Analysis|||Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG [0 vs. 1], HPV status [Positive vs. Negative] and PD-L1 TPS status [Strongly Positive, Not Strongly Positive]) as covariates.|
1619207|NCT02358031|2973840|Other||Difference in ORR Percentage|-12.8||||0.9869|2-Sided|95.0|-23.8|-1.5||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥20 participants of the pembro mono arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen & Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).|
1619208|NCT02358031|2973841|Other||Difference in ORR Percentage|-15.9||||1|2-Sided|95.0|-23.4|-8.3||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen & Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).|
1619209|NCT02358031|2973842|Other||Difference in ORR Percentage|-19.0||||1|2-Sided|95.0|-25.8|-12.1||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in all participants of the pembro mono arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen & Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive , Not Strongly Positive).|
1619210|NCT02358031|2973849|Other||Hazard Ratio (HR)|1.05||||0.5836|2-Sided|95.0|0.69|1.59||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H&N35 Swallowing Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).|
1619211|NCT02358031|2973850|Other||Hazard Ratio (HR)|1.37||||0.9476|2-Sided|95.0|0.93|2.02||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in EORTC QLQ-H&N35 Pain Score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).|
1619212|NCT02358031|2973851|Other||Hazard Ratio (HR)|1.37||||0.9497|2-Sided|95.0|0.94|2.0||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Regression, Cox|||TTD in GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).|
1619213|NCT02358031|2973852|Other||Difference in LS Means|0.4||||0.839|2-Sided|95.0|-3.46|4.26||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|constrained Longitudinal Data Analysis|||Change from baseline to Week 15 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm. Comparison based on constrained longitudinal data analysis (cLDA) model with GHS/QoL score as response variable and treatment by visit interaction, stratification factors (ECOG [0 vs. 1], HPV status [Positive vs. Negative] and PD-L1 TPS status [Strongly Positive, Not Strongly Positive]) as covariates.|
1619214|NCT02358031|2973853|Other||Difference in ORR Percentage|5.0||||0.2161|2-Sided|95.0|-7.5|17.4||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥20 participants of the pembro combo arm was compared to ORR in CPS ≥20 participants of the control arm. The comparison was based on Miettinen & Nurminen method stratified by ECOG (0 vs. 1) and HPV status (Positive vs. Negative).|
1619215|NCT02358031|2973854|Other||Difference in ORR Percentage|0.5||||0.4586|2-Sided|95.0|-8.2|9.1||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in CPS ≥1 participants of the pembro combo arm was compared to ORR in CPS ≥1 participants of the control arm. The comparison was based on Miettinen & Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).|
1619216|NCT02358031|2973855|Other||Difference in ORR Percentage|-0.8||||0.574|2-Sided|95.0|-8.7|7.2||No formal hypothesis testing performed; nominal p-value provided for treatment comparison.|Miettinen & Nurminen method|||ORR in all participants of the pembro combo arm was compared to ORR in all participants of the control arm. The comparison was based on Miettinen & Nurminen method stratified by ECOG (0 vs. 1), HPV status (Positive vs. Negative) and PD-L1 TPS status (Strongly Positive, Not Strongly Positive).|
1619217|NCT02358031|2973862|Superiority||Hazard Ratio (HR)|0.58||||0.0001|2-Sided|95.0|0.44|0.78||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||OS in CPS ≥20 participants of the pembro mono arm was compared to OS in CPS ≥20 participants of the control arm to address the seventh primary hypothesis. The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG and HPV status.|
1619218|NCT02358031|2973863|Superiority||Hazard Ratio (HR)|0.74||||0.00133|2-Sided|95.0|0.61|0.9||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in CPS ≥1 participants of the pembro mono arm was compared to OS in CPS ≥1 participants of the control arm to address the eighth primary hypothesis. The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.|
1619219|NCT02358031|2973864|Superiority||Hazard Ratio (HR)|0.83||||0.01985|2-Sided|95.0|0.7|0.99||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in all participants of the pembro mono arm was compared to OS in all participants of the control arm to address the tenth primary hypothesis. The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.|
1619220|NCT02358031|2973865|Superiority||Hazard Ratio (HR)|0.99||||0.46791|2-Sided|95.0|0.76|1.29||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||PFS in CPS ≥20 participants of the pembro mono arm was compared to PFS in CPS ≥20 participants of the control arm to address the first primary hypothesis. The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG and HPV status.|
1619221|NCT02358031|2973866|Superiority||Hazard Ratio (HR)|1.13||||0.8958|2-Sided|95.0|0.94|1.36||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the control arm to address the second primary hypothesis. The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.|
1619222|NCT02358031|2973867|Superiority||Hazard Ratio (HR)|1.29||||0.9983|2-Sided|95.0|1.09|1.53||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in all participants of the pembro mono arm was compared to PFS in all participants of the control arm to address the third primary hypothesis. The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.|
1619223|NCT02358031|2973868|Superiority||Hazard Ratio (HR)|0.6||||0.00044|2-Sided|95.0|0.45|0.82||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||OS in CPS ≥20 participants of the pembro combo arm was compared to OS in CPS ≥20 participants of the control arm to address the eleventh primary hypothesis. The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG and HPV status.|
1619224|NCT02358031|2973869|Superiority||Hazard Ratio (HR)|0.65||||2e-05|2-Sided|95.0|0.53|0.8||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the control arm to address the twelfth primary hypothesis. The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.|
1619225|NCT02358031|2973870|Superiority||Hazard Ratio (HR)|0.72||||0.00025|2-Sided|95.0|0.6|0.87||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||OS in all participants of the pembro combo arm was compared to OS in all participants of the control arm to address the fourteenth primary hypothesis. The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.|
1619226|NCT02358031|2973871|Superiority||Hazard Ratio (HR)|0.76||||0.02951|2-Sided|95.0|0.58|1.01||One-sided p-value based on log-rank test stratified by ECOG and HPV status.|Regression, Cox|||PFS in CPS ≥20 participants of the pembro combo arm was compared to PFS in CPS ≥20 participants of the control arm to address the fourth primary hypothesis. The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG and HPV status.|
1619227|NCT02358031|2973872|Superiority||Hazard Ratio (HR)|0.84||||0.03697|2-Sided|95.0|0.69|1.02||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the control arm to address the fifth primary hypothesis. The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.|
1619228|NCT02358031|2973873|Superiority||Hazard Ratio (HR)|0.93||||0.21211|2-Sided|95.0|0.78|1.11||One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.|Regression, Cox|||PFS in all participants of the pembro combo arm was compared to PFS in all participants of the control arm to address the sixth primary hypothesis. The comparison was based on a Cox regression model with Efron’s method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.|
1619229|NCT02357901|2973937|Superiority||LSM difference|7.5|Standard Error of the Mean|0.86|<|0.0001|2-Sided|95.0|5.82|9.21||Significance level of 0.05.|ANOVA|a random effects ANOVA model with treatment included as fixed effect and center as random effect.|||
1619230|NCT02357901|2973937|Superiority||LSM difference|7.5|Standard Error of the Mean|0.86|<|0.0001|2-Sided|95.0|5.81|9.2||Significance level of 0.05.|ANOVA|a random effects ANOVA model with treatment included as fixed effect and center as random effect.|||
1619231|NCT02357901|2973938|Superiority||LSM difference|-2.6|Standard Error of the Mean|0.87||0.0028|2-Sided|95.0|-4.32|-0.9||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.|
1619232|NCT02357901|2973938|Superiority||LSM difference|-1.6|Standard Error of the Mean|0.87||0.0726|2-Sided|95.0|-3.29|0.14||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.|
1619233|NCT02357901|2973939|Superiority||LSM difference|-1.0|Standard Error of the Mean|0.38||0.0101|2-Sided|95.0|-1.72|-0.23||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.|
1619234|NCT02357901|2973939|Superiority||LSM difference|-0.4|Standard Error of the Mean|0.38||0.3143|2-Sided|95.0|-1.13|0.36||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.|
1619235|NCT02357901|2973940|Superiority||LSM difference|-0.7|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-0.97|-0.41||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.|
1619236|NCT02357901|2973940|Superiority||LSM difference|-0.6|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-0.89|-0.33||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.|
1619237|NCT02357901|2973941|Superiority||LSM difference|-0.9|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-1.12|-0.62||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.|
1619467|NCT02349152|2974757|Superiority|||||||1|||||||Chi-squared|||cardiac arrest|
1619468|NCT02349152|2974757|Superiority|||||||0.1|||||||Chi-squared|||Atrial Fibrillation|
1619238|NCT02357901|2973941|Superiority||LSM difference|-0.7|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-0.96|-0.46||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.|
1619239|NCT02357901|2973942|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site|||
1619240|NCT02357901|2973942|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site|||
1619241|NCT02357901|2973943|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site|||
1619242|NCT02357901|2973943|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel|stratified by site|||
1619243|NCT02357901|2973944|Superiority||LSM difference|-12.4|Standard Error of the Mean|2.61|<|0.0001|2-Sided|95.0|-17.51|-7.28||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.|
1619244|NCT02357901|2973944|Superiority||LSM difference|-9.4|Standard Error of the Mean|2.62|<|0.0003|2-Sided|95.0|-14.56|-4.3||Significance level of 0.05.|mixed model for repeated measures|||Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect.|
1619245|NCT02357901|2973945|Superiority||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test||||
1619246|NCT02357901|2973945|Superiority||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test||||
1619247|NCT02357901|2973946|Superiority||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test||||
1619248|NCT02357901|2973946|Superiority||||||<|0.0001||||||Significance level of 0.05.|Wilcoxon rank-sum test||||
1619249|NCT02357901|2973947|Superiority||||||<|0.0001||||||Significance level of 0.05.|Cochran-Mantel-Haenszel||||
1619250|NCT02357901|2973947|Superiority||||||<|0.0001||||||Significance level of 0.05.|Cochran-Mantel-Haenszel||||
1619251|NCT02357901|2973948|Superiority||||||<|0.0001||||||significance at the 0.025 level|Wilcoxon rank-sum test||||
1619252|NCT02357901|2973948|Superiority||||||<|0.0001||||||significance at the 0.025 level|Wilcoxon rank-sum test||||
1619253|NCT02357706|2973960|Non-Inferiority|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|2.69||||0.134|2-Sided||||||t-test, 1 sided||||
1619254|NCT02357706|2973960|Non-Inferiority|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|2.69||||0.205|2-Sided||||||t-test, 1 sided||||
1619255|NCT02357706|2973961|Non-Inferiority|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs~The expected difference mu is 0 events/hr The Non-Inferiority Margin delta is 0.75 events/hr (A difference of 1 event per hour is seen as clinically significant. 0.75 has been chosen to ensure any AHI change is seen)."|Mean Difference (Net)|1.24||||0.05|2-Sided||||||t-test, 1 sided||||
1619256|NCT02357706|2973961|Non-Inferiority or Equivalence (legacy)|"We are testing the Hypothesis that there is a significant difference between CPAP A and CPAP B~The Null Hypothesis is H0 = One CPAP is inferior to the other CPAP The Alternate Hypothesis is H1 = There is no significant difference between the CPAPs"|Mean Difference (Final Values)|1.24||||0.537|2-Sided||||||t-test, 1 sided|||"Comparison of AHI/ oxygen desaturation index (ODI) of Device A compared with Device B.~Efficacy is defined as a residual AHI and ODI on each night of the trial. PSG scored AHI and ODI will be collected on both trial nights (excluding the ramp period); and compared using the Paired T test"|
1619257|NCT02357576|2973976|Other|The Kaplan Meier curve was used to evaluated the time to first PNAC event.||||||0.2716|||||||Log Rank|A log rank test was used to test the equality of the survival curve between the two groups.|||
1619258|NCT02357576|2973977|Other|Percentage and frequencies were used to describe the incidence of severe PNAC.||||||0.45|||||||Fisher Exact||||
1619259|NCT02357576|2973978|Other|Percentage and frequencies were used to describe the incidence of PNAC in the two groups.||||||0.617|||||||Fisher Exact||||
1619260|NCT02357485|2973980|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1619261|NCT02357485|2973981|Superiority or Other|||||||0.053|||||||t-test, 2 sided||||
1619262|NCT02357485|2973982|Superiority or Other||||||<|0.001||||||Baseline vs 1 year Post-treatment|t-test, 2 sided||||
1619263|NCT02357485|2973983|Superiority or Other||||||<|0.004||||||Baseline vs 1 year Post-treatment|t-test, 2 sided||||
1619264|NCT02357459|2973998|Superiority|The analysis included all study weeks of data, and was not confined to only that at Baseline and Week 12. Descriptive statistics included number of observations, unadjusted mean, standard deviation, median, minimum and maximum, and baseline adjusted means from the mixed model. Treatment differences from control was presented, and estimated via least squares means from the analysis model along with 95% confidence intervals and associated 2-sided p-values.|Mean Difference (Final Values)|-0.98|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|-1.47|-0.49||The threshold for significance was <0.05.|longitudinal mixed repeated measures||||
1619265|NCT02357420|2974001|Superiority|||||||0.59|||||||MMRM|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.|||
1619266|NCT02357420|2974001|Superiority|||||||0.25|||||||MMRM|MMRM analysis used treatment, week, treatment-by-week interaction as fixed factors and baseline values as the covariates.|||
1619274|NCT02355665|2974126|Superiority||Least Squares Mean Difference|7.13|Standard Error of the Mean|4.573||0.138|2-Sided|95.0|-2.56|16.83||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.|
1619275|NCT02355665|2974127|Superiority||Least Squares Mean Difference|3.04|Standard Error of the Mean|3.409||0.383|2-Sided|95.0|-4.03|10.11||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.|
1619276|NCT02355665|2974128|Superiority||Least Squares Mean Difference|0.99|Standard Error of the Mean|1.679||0.558|2-Sided|95.0|-2.42|4.41||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment, baseline smoking category, study site, and baseline weight were factors.|Least Squares Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in mean change from baseline in body weight between treatments. The alternative hypothesis was a difference in mean change from baseline in body weight between treatments.|
1619277|NCT02355665|2974297|Superiority||Estimated Mean Difference|-1.01||||0.354|2-Sided|95.0|-2.93|0.91||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.|
1619278|NCT02355665|2974298|Superiority||Estimated Mean Difference|-0.45||||0.532|2-Sided|95.0|-2.27|1.38||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.|
1619279|NCT02355665|2974299|Superiority||Estimated Mean Difference|-1.79||||0.102|2-Sided|95.0|-4.24|0.67||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.|
1619280|NCT02355665|2974300|Superiority||Estimated Mean Difference|-0.56||||0.483|2-Sided|95.0|-2.84|1.73||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of aggregated withdrawal scores between treatments. The alternative hypothesis was a difference in distribution of aggregated withdrawal scores between treatments.|
1619281|NCT02355665|2974301|Superiority||Estimated Mean Difference|-0.11||||0.502|2-Sided|95.0|-0.62|0.4||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.|
1619282|NCT02355665|2974302|Superiority||Estimated Mean Difference|-0.35||||0.194|2-Sided|95.0|-0.93|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.|
1619283|NCT02355665|2974303|Superiority||Estimated Mean Difference|-0.04||||0.604|2-Sided|95.0|-0.6|0.51||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.|
1619284|NCT02355665|2974304|Superiority||Estimated Mean Difference|-0.3||||0.105|2-Sided|95.0|-0.93|0.33||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of increased appetite between treatments. The alternative hypothesis was a difference in distribution of the ratings of increased appetite between treatments.|
1619285|NCT02355665|2974305|Superiority||Estimated Mean Difference|-0.42||||0.027|2-Sided|95.0|-0.77|-0.06||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.|
1619286|NCT02355665|2974306|Superiority||Estimated Mean Difference|-0.08||||0.517|2-Sided|95.0|-0.44|0.28||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.|
1619287|NCT02355665|2974307|Superiority||Estimated Mean Difference|0.13||||0.438|2-Sided|95.0|-0.3|0.57||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.|
1619288|NCT02355665|2974308|Superiority||Estimated Mean Difference|0.0||||0.804|2-Sided|95.0|-0.4|0.4||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of insomnia between treatments. The alternative hypothesis was a difference in distribution of the ratings of insomnia between treatments.|
1619348|NCT02353871|2974457|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148|
1619289|NCT02355665|2974309|Superiority||Estimated Mean Difference|0.02||||0.823|2-Sided|95.0|-0.28|0.32||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.|
1619290|NCT02355665|2974310|Superiority||Estimated Mean Difference|-0.06||||0.879|2-Sided|95.0|-0.4|0.28||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.|
1619291|NCT02355665|2974311|Superiority||Estimated Mean Difference|-0.05||||0.273|2-Sided|95.0|-0.42|0.32||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.|
1619292|NCT02355665|2974312|Superiority||Estimated Mean Difference|0.04||||0.635|2-Sided|95.0|-0.28|0.36||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of dysphoric or depressed mood between treatments. The alternative hypothesis was a difference in distribution of the ratings of dysphoric or depressed mood between treatments.|
1619293|NCT02355665|2974313|Superiority||Estimated Mean Difference|-0.06||||0.731|2-Sided|95.0|-0.44|0.31||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.|
1619294|NCT02355665|2974314|Superiority||Estimated Mean Difference|0.04||||0.9|2-Sided|95.0|-0.3|0.38||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.|
1619295|NCT02355665|2974315|Superiority||Estimated Mean Difference|-0.63||||0.014|2-Sided|95.0|-1.16|-0.09||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.|
1619296|NCT02355665|2974316|Superiority||Estimated Mean Difference|-0.03||||0.608|2-Sided|95.0|-0.54|0.49||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of anxiety between treatments. The alternative hypothesis was a difference in distribution of the ratings of anxiety between treatments.|
1619297|NCT02355665|2974317|Superiority||Estimated Mean Difference|-0.11||||0.721|2-Sided|95.0|-0.48|0.25||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.|
1619298|NCT02355665|2974318|Superiority||Estimated Mean Difference|0.13||||0.891|2-Sided|95.0|-0.24|0.51||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.|
1619299|NCT02355665|2974319|Superiority||Estimated Mean Difference|-0.21||||0.325|2-Sided|95.0|-0.66|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.|
1619300|NCT02355665|2974320|Superiority||Estimated Mean Difference|0.01||||0.925|2-Sided|95.0|-0.44|0.47||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of difficulty concentrating between treatments. The alternative hypothesis was a difference in distribution of the ratings of difficulty concentrating between treatments.|
1619301|NCT02355665|2974321|Superiority||Estimated Mean Difference|-0.23||||0.179|2-Sided|95.0|-0.59|0.13||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.|
1619302|NCT02355665|2974322|Superiority||Estimated Mean Difference|-0.14||||0.392|2-Sided|95.0|-0.47|0.2||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.|
1619303|NCT02355665|2974323|Superiority||Estimated Mean Difference|-0.41||||0.116|2-Sided|95.0|-0.89|0.08||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.|
1619304|NCT02355665|2974324|Superiority||Estimated Mean Difference|-0.17||||0.754|2-Sided|95.0|-0.78|0.43||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of restlessness between treatments. The alternative hypothesis was a difference in distribution of the ratings of restlessness between treatments.|
1619305|NCT02355665|2974325|Superiority||Estimated Mean Difference|-0.1||||0.3|2-Sided|95.0|-0.51|0.31||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.|
1619306|NCT02355665|2974326|Superiority||Estimated Mean Difference|0.0||||0.665|2-Sided|95.0|-0.5|0.49||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.|
1619307|NCT02355665|2974327|Superiority||Estimated Mean Difference|-0.58||||0.022|2-Sided|95.0|-1.15|-0.01||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.|
1619308|NCT02355665|2974328|Superiority||Estimated Mean Difference|-0.11||||0.433|2-Sided|95.0|-0.65|0.43||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of irritability/frustration/anger between treatments. The alternative hypothesis was a difference in distribution of the ratings of irritability/frustration/anger between treatments.|
1619309|NCT02355665|2974329|Superiority||Estimated Mean Difference|0.09||||0.487|2-Sided|95.0|-0.38|0.55||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.|
1619310|NCT02355665|2974330|Superiority||Estimated Mean Difference|-0.19||||0.266|2-Sided|95.0|-0.61|0.24||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.|
1619311|NCT02355665|2974331|Superiority||Estimated Mean Difference|-0.1||||0.861|2-Sided|95.0|-0.62|0.42||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.|
1619312|NCT02355665|2974332|Superiority||Estimated Mean Difference|-0.02||||0.847|2-Sided|95.0|-0.64|0.6||The significance threshold level was 0.05 (two-sided).|Wilcoxon (Mann-Whitney)||Estimated Mean Difference = Nicotine - Placebo|The null hypothesis was no difference in distribution of the ratings of desire/urge to smoke between treatments. The alternative hypothesis was a difference in distribution of the ratings of desire/urge to smoke between treatments.|
1619313|NCT02355665|2974333|Superiority||Estimated Success Rate Ratio|2.66||||0.013|2-Sided|95.0|1.2|5.92||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.|
1619314|NCT02355665|2974334|Superiority||Estimated Success Rate Ratio|2.91||||0.006|2-Sided|95.0|1.32|6.42||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.|
1619315|NCT02355665|2974335|Superiority||Estimated Success Rate Ratio|2.09||||0.023|2-Sided|95.0|1.09|3.98||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.|
1619316|NCT02355665|2974336|Superiority||Estimated Success Rate Ratio|1.66||||0.04|2-Sided|95.0|1.02|2.71||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.|
1619317|NCT02355665|2974337|Superiority||Estimated Success Rate Ratio|2.87||||0.011|2-Sided|95.0|1.23|6.71||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.|
1619318|NCT02355665|2974338|Superiority||Estimated Success Rate Ratio|3.04||||0.004|2-Sided|95.0|1.39|6.68||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.|
1619429|NCT02349451|2974701|Superiority||Least squares mean difference|-0.09|||<|0.696|2-Sided|95.0|-0.54|0.36||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA||||
1619319|NCT02355665|2974339|Superiority||Estimated Success Rate Ratio|2.0||||0.021|2-Sided|95.0|1.1|3.66||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study site and number of cigarettes smoked per day at baseline (<20 per day vs ≥20 per day).|Estimated Success Rate Ratio = Nicotine/Placebo|The null hypothesis was no difference in continuous smoking abstinence rates between treatments. The alternative hypothesis was a difference in continuous smoking abstinence rates between treatments.|
1619320|NCT02354976|2974361|Other||Geometric mean ratio for difference|0.84||||0.077|2-Sided|95.0|0.7|1.02|||Mixed Models Analysis||||
1619321|NCT02354976|2974362|Other||Geometric mean ratio for difference|0.92||||0.407|2-Sided|95.0|0.76|1.12|||Mixed Models Analysis||||
1619322|NCT02354859|2974366|Superiority||Mean Difference (Final Values)|4.23||||0.053|2-Sided|95.0|-0.06|8.53|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 6, Day 14, Day 28, and Day 56. Mixed-effects repeated measures model includes terms for the baseline CFRSD-CRISS score, treatment, visit and a visit-by-visit interaction.||
1619323|NCT02354859|2974367|Superiority||Mean Difference (Final Values)|-0.74||||0.054|2-Sided|95.0|-1.49|0.01|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 28 and Day 56. Mixed-effects repeated measures model includes terms for the baseline Pa density (log10 (CFU)), treatment, visit and a visit-by-visit interaction.||
1619324|NCT02354859|2974368|Superiority||Mean Difference (Final Values)|2.05||||0.479|2-Sided|95.0|-3.66|7.77|||Mixed Models Analysis||Analysis includes all data for relative change from baseline at Day 6, Day 14, Day 28, and Day 56. Mixed-effects repeated measures model includes terms for the baseline FEV1 (liters), treatment, visit and a visit-by-visit interaction.||
1619325|NCT02354859|2974369|Superiority||Rate Ratio|0.89||||0.783|2-Sided|95.0|0.39|2.03|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the IV Gallium group was 486.86 and in the Placebo group was 473.57.|
1619326|NCT02354859|2974369|Superiority||Rate Ratio|0.81||||0.002|2-Sided|95.0|0.71|0.93|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks of all participants (not per participant) in the trial was as follows: in the IV Gallium group was 486.86 and in the Placebo group was 473.57.|
1619327|NCT02354859|2974370|Superiority||Difference in Proportions-SAE inicidence|3.1||||0.807|2-Sided|95.0|-10.6|16.6|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson method without continuity correction.||
1619328|NCT02354859|2974371|Superiority||Difference in Proportions|5.9||||0.811|2-Sided|95.0|-11.2|22.4|||Cochran-Mantel-Haenszel||The estimate is adjusted for baseline FEV1 % predicted strata (<50% of predicted, between 50% and 70% of predicted, and >70% of predicted).||
1619329|NCT02354833|2974372|Superiority or Other|||||||0.73|||||||Wilcoxon (Mann-Whitney)||||
1619330|NCT02354833|2974373|Superiority or Other|||||||0.1|||||||Wilcoxon (Mann-Whitney)||||
1619331|NCT02354833|2974374|Superiority or Other||||||<|0.001|||||||Chi-squared|||This analysis is comparing the percentage of participants with Emesis|
1619332|NCT02354833|2974374|Superiority or Other||||||<|0.28|||||||Chi-squared|||This analysis is comparing the percentage of participants with Nausea|
1619333|NCT02354833|2974375|Superiority or Other|||||||0.12|||||||t-test, 2 sided||||
1619334|NCT02354352|2974441|Non-Inferiority|Using a Type I error rate of 5%, we conducted a power calculation using a non-inferiority test on 12-month change in Ecc. If there is truly no difference in the 12-month Ecc change between the spironolactone and eplerenone groups, 46 patients (23 in each group) would result in at least 80% power to ensure that the lower limit of a one-sided 95% confidence interval for the true difference between the spironolactone and eplerenone groups to be above the non-inferiority limit of -1.75.||||||0.5867|||||||Wilcoxon (Mann-Whitney)||||
1619335|NCT02354235|2974442|Superiority||Least Squares Mean Difference|-50.9|Standard Error of the Mean|7.1|<|0.001|2-Sided|95.0|-64.9|-36.9|||ANCOVA||||
1619336|NCT02354235|2974443|Superiority||Least Squares Mean Difference|-100.3|Standard Error of the Mean|11.1|<|0.001|2-Sided|95.0|-122.2|-78.4|||ANCOVA||||
1619337|NCT02354235|2974444|Superiority||Least Squares Mean Difference|-2.33|Standard Error of the Mean|0.44|<|0.001|2-Sided|95.0|-3.2|-1.45|||ANCOVA||||
1619338|NCT02354235|2974445|Superiority||Least Squares Mean Difference|-38.8|Standard Error of the Mean|4.9|<|0.001|2-Sided|95.0|-48.5|-29.2|||ANCOVA||||
1619339|NCT02354235|2974446|Superiority||Least Squares Mean Difference|-0.88|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-1.15|-0.6|||ANCOVA||||
1619340|NCT02354222|2974447|Superiority||Least Squares Mean Difference|-37.6|Standard Error of the Mean|6.2|<|0.001|2-Sided|95.0|-49.9|-25.2|||ANCOVA||||
1619341|NCT02354222|2974448|Superiority||Least Squares Mean Difference|-55.9|Standard Error of the Mean|9.2|<|0.001|2-Sided|95.0|-74.1|-37.6|||ANCOVA||||
1619342|NCT02354222|2974449|Superiority||Least Squares Mean Difference|1.43|Standard Error of the Mean|0.41|<|0.001|2-Sided|95.0|0.63|2.23|||ANCOVA||||
1619343|NCT02354222|2974450|Superiority||Least Squares Mean Difference|-15.6|Standard Error of the Mean|3.9|<|0.001|2-Sided|95.0|-23.3|-7.9|||ANCOVA||||
1619344|NCT02354222|2974451|Superiority||Least Squares Mean Difference|-0.94|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|-1.16|-0.72|||ANCOVA||||
1619345|NCT02353871|2974456|Superiority or Other||Hazard Ratio (HR)|6.561|||<|0.0001|2-Sided||||||Cox proportional hazard model|Centre, gender and ILA baseline severity score used as covariates.||Comparison of time to onset of treatment response - BTX-A-HAC NG solution (50 U) versus placebo|
1619346|NCT02353871|2974456|Superiority or Other||||||<|0.0001|||||||Log Rank|||Comparison of time to onset of treatment response - BTX-A-HAC NG solution (50 U) versus Placebo|
1619347|NCT02353871|2974457|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183|
1619430|NCT02349451|2974701|Superiority||Least squares mean difference|-1.17|||<|0.001|2-Sided|95.0|-1.81|-0.53||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA||||
1619349|NCT02353871|2974457|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113|
1619350|NCT02353871|2974457|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85|
1619351|NCT02353871|2974457|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57|
1619352|NCT02353871|2974457|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29|
1619353|NCT02353871|2974457|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15|
1619354|NCT02353871|2974457|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of subject's level of satisfaction - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8|
1619355|NCT02353871|2974458|Superiority or Other|||||||0.0036||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183|
1619356|NCT02353871|2974458|Superiority or Other|||||||0.0011||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148|
1619357|NCT02353871|2974458|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113|
1619358|NCT02353871|2974458|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - Dysport 50 U versus Placebo at Day 85|
1619359|NCT02353871|2974458|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57|
1619360|NCT02353871|2974458|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29|
1619361|NCT02353871|2974458|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15|
1619362|NCT02353871|2974458|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of SSA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8|
1619363|NCT02353871|2974459|Superiority or Other|||||||0.367||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183|
1619364|NCT02353871|2974459|Superiority or Other|||||||0.0643||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 148|
1619365|NCT02353871|2974459|Superiority or Other|||||||0.0065||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113|
1619366|NCT02353871|2974459|Superiority or Other|||||||0.0008||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85|
1619367|NCT02353871|2974459|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57|
1619368|NCT02353871|2974459|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29|
1619369|NCT02353871|2974459|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15|
1619370|NCT02353871|2974459|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8|
1619371|NCT02353871|2974460|Superiority or Other|||||||0.0015||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 183|
1619372|NCT02353871|2974460|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 113|
1619373|NCT02353871|2974460|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 85|
1619374|NCT02353871|2974460|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 57|
1619375|NCT02353871|2974460|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29|
1619376|NCT02353871|2974460|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 15|
1619377|NCT02353871|2974460|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (at rest)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 8|
1619378|NCT02353871|2974461|Superiority or Other|||||||0.7894||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 183 - BTX-A-HAC NG solution (50 U) versus Placebo|
1619379|NCT02353871|2974461|Superiority or Other|||||||0.701||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 148 - BTX-A-HAC NG solution (50 U) versus Placebo|
1619380|NCT02353871|2974461|Superiority or Other|||||||0.7064||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 113 - BTX-A-HAC NG solution (50 U) versus Placebo|
1619381|NCT02353871|2974461|Superiority or Other|||||||0.0917||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 85 - BTX-A-HAC NG solution (50 U) versus Placebo|
1619382|NCT02353871|2974461|Superiority or Other|||||||0.2422||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of the proportion of responders on Day 29 who remained responders at Day 57 - BTX-A-HAC NG solution (50 U) versus Placebo|
1619383|NCT02353871|2974462|Superiority or Other|||||||0.0441||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 183 (End of Study) - BTX-A-HAC NG solution (50 U) versus placebo|
1619384|NCT02353871|2974462|Superiority or Other|||||||0.0035||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 148 - BTX-A-HAC NG solution (50 U) versus placebo|
1619385|NCT02353871|2974462|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 113 - BTX-A-HAC NG solution (50 U) versus placebo|
1619386|NCT02353871|2974462|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 85 - BTX-A-HAC NG solution (50 U) versus placebo|
1619387|NCT02353871|2974462|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 57 - BTX-A-HAC NG solution (50 U) versus placebo|
1619431|NCT02349451|2974702|Superiority||Least squares mean difference|-0.45||||0.012|2-Sided|95.0|-0.81|-0.1||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA||||
1619388|NCT02353871|2974462|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 15 - BTX-A-HAC NG solution (50 U) versus placebo|
1619389|NCT02353871|2974462|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA at Day 8 - BTX-A-HAC NG solution (50 U) versus placebo|
1619390|NCT02353871|2974463|Superiority or Other||||||<|0.0001||||||Statistical tests were two-sided with a type I error rate at 5%.|Regression, Logistic|Multivariate model, controlling for centre and stratification factors (i.e. gender and baseline ILA (maximum frown)) as fixed effects.||Comparison of ILA - BTX-A-HAC NG solution (50 U) versus Placebo at Day 29|
1619391|NCT02352948|2974541|Superiority||Hazard Ratio (HR)|0.65||||0.002|2-Sided|95.0|0.49|0.85|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.|
1619392|NCT02352948|2974545|Superiority||Odds Ratio (OR)|2.46||||0.109|2-Sided|95.0|0.91|8.61|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.|
1619393|NCT02352948|2974545|Superiority||Odds Ratio (OR)|0.97||||0.923|2-Sided|95.0|0.51|1.89|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.|
1619394|NCT02352948|2974545|Superiority||Odds Ratio (OR)|2.43||||0.037|2-Sided|95.0|1.1|5.94|||Regression, Logistic||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.|
1619395|NCT02352948|2974545|Other|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Odds Ratio (OR)|3.87|||||2-Sided|95.0|1.61|10.1|||||The analysis was performed using logistic regression adjusting for SoC therapy (gemcitabine/vinorelbine versus erlotinib) and histology (squamous versus all other histology types), with 95% CI calculated by profile likelihood.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.|
1619396|NCT02352948|2974546|Superiority||Hazard Ratio (HR)|0.67||||0.011|2-Sided|95.0|0.49|0.92|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.|
1619397|NCT02352948|2974546|Superiority||Hazard Ratio (HR)|0.87||||0.282|2-Sided|95.0|0.68|1.12|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.|
1619398|NCT02352948|2974547|Superiority|||||||0.063||||||The z-test statistic is the ratio of log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by square root of the variance.|z-test|The variance is estimated using the delta method and Greenwood's formula.||For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.|
1619399|NCT02352948|2974548|Superiority||Hazard Ratio (HR)|0.78||||0.153|2-Sided|95.0|0.56|1.11|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with tremelimumab monotherapy.|
1619400|NCT02352948|2974548|Superiority||Hazard Ratio (HR)|0.98||||0.885|2-Sided|95.0|0.74|1.3|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|As part of the contribution of components analysis for sub-study B, durvalumab plus tremelimumab treatment arm was compared with durvalumab monotherapy.|
1619401|NCT02352948|2974549|Superiority||Hazard Ratio (HR)|0.77||||0.056|2-Sided|95.0|0.59|1.01|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.|
1619432|NCT02349451|2974702|Superiority||Least squares mean difference|-1.4|||<|0.001|2-Sided|95.0|-1.9|-0.89||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA||||
1619469|NCT02349152|2974757|Superiority|||||||1|||||||Chi-squared|||Renal Failure|
1619402|NCT02352948|2974549|Other|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Hazard Ratio (HR)|0.71|||||2-Sided|95.0|0.49|1.04|||||Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.|
1619403|NCT02352948|2974550|Superiority||Hazard Ratio (HR)|0.8||||0.109|2-Sided|95.0|0.61|1.05|||Log Rank|The P-value arises from a stratified log-rank test adjusting for SoC therapy and histology, with ties handled by the Breslow approach.|Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study B: durvalumab plus tremelimumab treatment arm was compared with SoC.|
1619404|NCT02352948|2974550|Other|Sub-study A was not powered and thus no formal statistical comparisons were performed.|Hazard Ratio (HR)|0.63|||||2-Sided|95.0|0.42|0.93|||||Hazard ratio and CI are estimated from a stratified Cox proportional hazards model with Breslow method to control for ties, stratification factors SoC therapy, and histology in strata statement, and CI is calculated using profile likelihood approach.|For sub-study A: durvalumab monotherapy treatment arm was compared with SoC.|
1619405|NCT02352779|2974561|Other||Mean Difference (Final Values)|2.9898|Standard Error of the Mean|3.5448||0.4016|2-Sided||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||MFSI-SF|
1619406|NCT02352779|2974561|Other||Mean Difference (Final Values)|0.0831|Standard Error of the Mean|3.8065||0.9826|2-Sided||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||MFSI-SF|
1619407|NCT02352779|2974561|Other||Mean Difference (Final Values)|0.6936|Standard Error of the Mean|0.4567||0.1329|2-Sided||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||BFI-SF|
1619408|NCT02352779|2974561|Other||Mean Difference (Final Values)|0.6763|Standard Error of the Mean|0.4843||0.1666|2-Sided||||||ANCOVA|Based on a contrast using the three-arm ANCOVA.||BFI-SF|
1619409|NCT02351934|2974594|Superiority|||||||0.985|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.|
1619410|NCT02351934|2974595|Superiority|||||||0.595|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.|
1619411|NCT02351934|2974597|Superiority|||||||0.125|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.|
1619412|NCT02351934|2974598|Superiority|||||||0.675|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.|
1619413|NCT02351934|2974599|Superiority|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Significance level of 0.05 was used.|
1619414|NCT02350309|2974679|Superiority or Other (legacy)||||||<|0.0001||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar||||
1619415|NCT02350309|2974679|Superiority or Other (legacy)||||||<|0.0001||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar||||
1619416|NCT02350309|2974679|Superiority or Other (legacy)||||||<|0.0215||||||P-value was calculated based on non-missing two-way contingency table between placebo and study treatment.|McNemar||||
1619417|NCT02350309|2974680|Superiority or Other (legacy)||Mean Difference (Final Values)|-3.48|||<|0.0001|1-Sided|95.0|-4.46|||The mixed model included treatment, period and sequence as fixed effects, baseline (predose) measurement as a covariate, and participant nested within treatment sequence as a random effect.|Mixed Models Analysis||||
1619418|NCT02350309|2974680|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.15|||<|0.0262|1-Sided|95.0|-2.12|||The mixed model included treatment, period and sequence as fixed effects, baseline (predose) measurement as a covariate, and participant nested within treatment sequence as a random effect.|Mixed Models Analysis||||
1619419|NCT02349477|2974697|Superiority|||||||0.67|||||||Chi-squared|||For the Low AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.|
1619420|NCT02349477|2974697|Superiority|||||||0.001|||||||Chi-squared|||For the High AWS group, a chi squared analysis compares the number of individuals with no heavy drinking days between medication groups.|
1619421|NCT02349477|2974698|Superiority||Odds Ratio (OR)|4.9||||0.053|2-Sided||||||Regression, Logistic|This is the p-value output from the logistic regression model where medication group predicted the discrete variable for abstinence.||This analysis compares between Gabapentin and Placebo, the number of individuals who reported no drinking days (abstinence) throughout the entire trial, corrected for %dCDT.|
1619422|NCT02349477|2974699|Superiority||Odds Ratio (OR)|3.9||||0.028|2-Sided||||||Regression, Logistic|This is the p-value output from the logistic regression model where medication group predicted the discrete variable for no heavy drinking days.||This analysis compares between Gabapentin and Placebo, the number of individuals who reported no heavy drinking days throughout the entire trial, corrected for %dCDT.|
1619423|NCT02349451|2974700|Superiority||Least squares mean difference|-0.37||||0.288|2-Sided|95.0|-1.06|0.32||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA||||
1619424|NCT02349451|2974700|Superiority||Least squares mean difference|-2.73|||<|0.001|2-Sided|95.0|-3.7|-1.75||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA||||
1619425|NCT02349451|2974700|Superiority||Least squares mean difference|-0.81|||<|0.021|2-Sided|95.0|-1.51|-0.12||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA||||
1619426|NCT02349451|2974700|Superiority||Least squares mean difference|-3.17|||<|0.001|2-Sided|95.0|-4.14|-2.19||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA||||
1619427|NCT02349451|2974701|Superiority||Least squares mean difference|-0.33||||0.151|2-Sided|95.0|-0.77|0.12||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA||||
1619428|NCT02349451|2974701|Superiority||Least squares mean difference|-1.41|||<|0.001|2-Sided|95.0|-2.04|-0.77||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA||||
1620549|NCT02314546|2977581|Superiority or Other|||||||0.73|||||||Chi-squared||||
1619434|NCT02349451|2974702|Superiority||Least squares mean difference|-1.07|||<|0.001|2-Sided|95.0|-1.58|-0.57||Two-sided p-value is calculated from ANCOVA model with treatment group as the fixed factor and baseline value as the covariate.|ANCOVA||||
1619435|NCT02349451|2974703|Superiority|||||||0.106||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.|Kolmogorov-Smirnov test||||
1619436|NCT02349451|2974703|Superiority||||||<|0.001||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.|Kolmogorov-Smirnov test||||
1619437|NCT02349451|2974703|Superiority||||||<|0.561||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with adalimumab group.|Kolmogorov-Smirnov test||||
1619438|NCT02349451|2974703|Superiority||||||<|0.001||||||Kolmogorov-Smirnov test based on the empirical distribution function is applied to get the p-value of comparing the ABT-122 treatment group with placebo group.|Kolmogorov-Smirnov test||||
1619439|NCT02349451|2974704|Superiority||response rate difference|16.2||||0.017|2-Sided|95.0|2.3|29.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact||||
1619440|NCT02349451|2974704|Superiority||response rate difference|27.3||||0.004|2-Sided|95.0|9.6|39.0||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact||||
1619441|NCT02349451|2974704|Superiority||response rate difference|7.3||||0.185|2-Sided|95.0|-5.8|19.9||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact||||
1619442|NCT02349451|2974704|Superiority||response rate difference|18.4||||0.034|2-Sided|95.0|1.5|29.7||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact||||
1619443|NCT02349451|2974705|Superiority||response rate difference|15.9||||0.039|2-Sided|95.0|-0.3|31.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact||||
1619444|NCT02349451|2974705|Superiority||response rate difference|40.9|||<|0.001|2-Sided|95.0|20.1|55.8||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact||||
1619445|NCT02349451|2974705|Superiority||response rate difference|-0.9|||<|0.611|2-Sided|95.0|-16.5|14.8||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact||||
1619446|NCT02349451|2974705|Superiority||response rate difference|24.1|||<|0.021|2-Sided|95.0|3.9|39.3||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group.|Fisher Exact||||
1619447|NCT02349451|2974706|Superiority||response rate difference|7.3||||0.215|2-Sided|95.0|-7.4|21.6||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact||||
1619448|NCT02349451|2974706|Superiority||response rate difference|-3.3||||0.723|2-Sided|95.0|-18.5|12.1||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to adalimumab group.|Fisher Exact||||
1619449|NCT02349451|2974707|Superiority||response rate difference|50.3|||<|0.001|2-Sided|95.0|28.1|67.4||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.|Fisher Exact||||
1619450|NCT02349451|2974707|Superiority||response rate difference|39.8|||<|0.001|2-Sided|95.0|17.2|57.7||P-value is calculated by one-sided Fisher's exact test to test whether ABT-122 treatment group is superior to placebo group. The a priori statistical significance threshold is P = 0.025.|Fisher Exact||||
1619451|NCT02349412|2974718|Superiority|||||||0.006|||||||Chi-squared||||
1619452|NCT02349412|2974719|Superiority||Mean Difference (Final Values)|-0.81||||0.033|2-Sided|95.0|-1.54|-0.07|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Anxiety score|||
1619453|NCT02349412|2974720|Superiority||Mean Difference (Final Values)|0.08||||0.884|2-Sided|95.0|-0.94|2.09|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline HADS-Depression score|||
1619454|NCT02349412|2974721|Superiority||Mean Difference (Final Values)|3.12||||0.188|2-Sided|95.0|-1.54|7.77|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score|||
1619455|NCT02349412|2974722|Superiority||Mean Difference (Final Values)|3.23||||0.104|2-Sided|95.0|-0.67|7.13|||ANCOVA|Statistical Method: Available Case ANCOVA Model adjusting for baseline FACT-G score|||
1619456|NCT02349295|2974750|Other|1) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.|Odds Ratio (OR)|3.79|||<|0.001|2-Sided|95.0|2.12|6.78|||Regression, Logistic|||model includes: treatment, geographic region, and TNFi experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi)|
1619457|NCT02349295|2974750|Other||Odds Ratio (OR)|4.74|||<|0.001|2-Sided|95.0|2.65|8.48||model includes: treatment, geographic region, and tumor necrosis factor inhibitor (TNFi) experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi).|Regression, Logistic|1) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.|||
1619458|NCT02349152|2974752|Superiority|||||||0.35|||||||Wilcoxon (Mann-Whitney)||||
1619459|NCT02349152|2974756|Superiority|||||||0.977|||||||t-test, 2 sided|||Hrs 43-48|
1619460|NCT02349152|2974756|Superiority|||||||0.501|||||||t-test, 2 sided|||Hrs 37-42|
1619461|NCT02349152|2974756|Superiority|||||||0.924|||||||t-test, 2 sided|||Hrs 31-36|
1619462|NCT02349152|2974756|Superiority|||||||0.568|||||||t-test, 2 sided|||Hrs 25-30|
1619463|NCT02349152|2974756|Superiority|||||||0.747|||||||t-test, 2 sided|||Hrs 19-24|
1619464|NCT02349152|2974756|Superiority|||||||0.006|||||||t-test, 2 sided|||Hrs 13-18|
1619465|NCT02349152|2974756|Superiority|||||||0.339|||||||t-test, 2 sided|||Hrs 7-12|
1619466|NCT02349152|2974756|Superiority|||||||0.205|||||||t-test, 2 sided|||Hrs 0-6|
1619474|NCT02349152|2974758|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.261|||||||t-test, 2 sided|||Analyzing the Glucagon 8-hr|
1619475|NCT02349152|2974758|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.062|||||||t-test, 2 sided|||Analyzing the Glucagon Post-bypass|
1619476|NCT02349152|2974758|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.175|||||||t-test, 2 sided|||Analyzing the Glucagon CPB-END|
1619477|NCT02349152|2974758|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.059|||||||t-test, 2 sided|||Analyzing the Glucagon CPB-30|
1619478|NCT02349152|2974758|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.455|||||||t-test, 2 sided|||Analyzing the Glucagon Pre Bypass|
1619479|NCT02349152|2974758|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.695|||||||t-test, 2 sided|||Analyzing the GH-8-hr|
1619480|NCT02349152|2974758|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.046|||||||t-test, 2 sided|||GH-Post-bypass|
1619481|NCT02349152|2974758|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.009|||||||t-test, 2 sided|||Analyzing the GH-CPB-END|
1619482|NCT02349152|2974758|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||GH-CPB-30|
1619483|NCT02349152|2974758|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.1|||||||t-test, 2 sided|||Analyzing the GH- Pre-bypass|
1619484|NCT02349152|2974758|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.014|||||||t-test, 2 sided|||Analyzing the ACTH 8-hr|
1619485|NCT02349152|2974758|Non-Inferiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH post-bypass|
1619486|NCT02349152|2974758|Non-Inferiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH CPB-END|
1619487|NCT02349152|2974758|Non-Inferiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||Analyzing the ACTH CPB-30 group.|
1619488|NCT02349152|2974758|Non-Inferiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.74|||||||t-test, 2 sided|||Analyzing the ACTH Pre-bypass group|
1619489|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.074|||||||t-test, 2 sided|||Analyzing the TNFa-8HR|
1619490|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.004|||||||t-test, 2 sided|||Analyzing the TNFa- post-bypass|
1619491|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.09|||||||t-test, 2 sided|||Analyzing the TNFa CPB-END|
1619492|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.062|||||||t-test, 2 sided|||Analyzing the TNFa CPB-30|
1619493|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.315|||||||t-test, 2 sided|||Analyzing the TNFa Pre-bypass|
1619494|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.601|||||||t-test, 2 sided|||Analyzing the IL-6 8HR|
1619495|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.274|||||||t-test, 2 sided|||Analyzing the IL-6 post-bypass|
1619496|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.779|||||||t-test, 2 sided|||Analyzing the CPB-END|
1619497|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.284|||||||t-test, 2 sided|||Analyzing the IL-6 CPB-30|
1619561|NCT02347176|2974936|Superiority||Adjusted Mean Difference|-4.94|Standard Error of the Mean|1.932||0.011|2-Sided|95.0|-8.76|-1.13|||Mixed Model Repeated Measures Analysis||||
1619498|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.439|||||||t-test, 2 sided|||Analyzing the IL-6 Pre bypass|
1619499|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.651|||||||t-test, 2 sided|||Analyzing the IL-1b 8 HR|
1619500|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.33|||||||t-test, 2 sided|||Analyzing the IL-1b post-bypass|
1619501|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.715|||||||t-test, 2 sided|||Analyzing the CPB-END|
1619502|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.815|||||||t-test, 2 sided|||Analyzing the IL-1b CPB-30|
1619503|NCT02349152|2974759|Superiority|Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.58|||||||t-test, 2 sided|||Analyzing the IL-1b Pre bypass|
1619504|NCT02349152|2974760|Non-Inferiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.021|||||||t-test, 2 sided|||Postoperative (8 hours)|
1619505|NCT02349152|2974760|Non-Inferiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||End of Surgery|
1619506|NCT02349152|2974760|Non-Inferiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||End of CPB|
1619507|NCT02349152|2974760|Non-Inferiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.0001|||||||t-test, 2 sided|||30 minutes after the start of CPB|
1619508|NCT02349152|2974760|Superiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.|||||<|0.401|||||||t-test, 2 sided|||Prebypass|
1619509|NCT02349152|2974762|Superiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.49|||||||t-test, 2 sided||||
1619510|NCT02349152|2974763|Superiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.25|||||||t-test, 2 sided|||Peak Postoperative Blood Glucose|
1619511|NCT02349152|2974763|Superiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.14|||||||t-test, 2 sided|||Mean post-operative glucose|
1619512|NCT02349152|2974764|Superiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.98|||||||t-test, 2 sided|||Lowest Intraoperative Blood Glucose|
1619513|NCT02349152|2974764|Superiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.0003|||||||t-test, 2 sided|||Peak Intraoperative Blood Glucose|
1619514|NCT02349152|2974764|Superiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.0001|||||||t-test, 2 sided|||Mean Intraoperative Blood Glucose|
1619515|NCT02349152|2974765|Superiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG>180 mg/dl) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha= 0.05) between the groups. A total of 116 patients were recruited to allow for dropouts.||||||0.01|||||||Fisher Exact||||
1619516|NCT02349152|2974766|Superiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts.||||||0.004|||||||t-test, 2 sided||||
1619517|NCT02349152|2974767|Superiority|Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG>180 mg/dl) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha= 0.05) between the groups. A total of 116 patients were recruited to allow for dropouts.|Risk Ratio (RR)|1.9||||0.001|2-Sided|95.0|1.3|3.0|||Chi-squared|||The null hypothesis that there was no difference in the percentage of patients with two or more blood glucose values greater than 180mg/dl between the two groups. Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG>180 mg/dl) to an absolute value of 20%.|
1619518|NCT02349061|2974768|Superiority||LS Means Difference|-2.17||||0.1032|2-Sided|95.0|-4.78|0.45|||Mixed model repeated measures model||||
1619519|NCT02349061|2974769|Superiority||Odds Ratio (OR)|1.0||||0.9939|2-Sided|95.0|0.43|2.34|||Regression, Logistic||||
1619520|NCT02349061|2974770|Superiority||LS Means Difference|-0.383||||0.3944|2-Sided|95.0|-1.271|0.506|||Mixed model repeated measures model||||
1619521|NCT02349061|2974771|Superiority||Least Squares (LS) Mean Difference|-1.36||||0.0929|2-Sided|95.0|-2.94|0.23|||Mixed model repeated measures model||||
1619522|NCT02349061|2974772|Superiority||Odds Ratio (OR)|3.28||||0.0057|2-Sided|95.0|1.41|7.63|||Regression, Logistic||||
1619523|NCT02348723|2974788|Superiority or Other||Risk Difference (RD) %|-5.3||||0.0009|2-Sided|95.0|-8.4|-2.2|||Chi-squared|||The risk difference between dabigatran etexilate vs. warfarin, its 2-sided 95% CI, and corresponding p-value are presented.|
1619524|NCT02347787|2974847|Superiority|||||||0.06|||||||Regression, Linear||||
1619525|NCT02347787|2974848|Superiority|||||||0.09|||||||Regression, Linear||||
1619526|NCT02347787|2974850|Superiority|||||||0.04|||||||Regression, Logistic||||
1619527|NCT02347787|2974851|Superiority|||||||0.02|||||||Regression, Logistic||||
1619528|NCT02347787|2974852|Superiority||||||<|0.001|||||||Regression, Logistic||||
1619529|NCT02347787|2974854|Superiority||Odds Ratio (OR)|1.0||||0.98|2-Sided|95.0|0.6|1.5|||Regression, Logistic||||
1619530|NCT02347787|2974855|Superiority||||||<|0.001|||||||Regression, Logistic||||
1619531|NCT02347787|2974856|Superiority|||||||0.41|||||||Regression, Linear||||
1619532|NCT02347787|2974857|Superiority||Risk Difference (RD)|-6.3||||0.21|2-Sided|95.0|-14.3|1.8|||Regression, Linear||||
1619533|NCT02347787|2974858|Superiority||Risk Difference (RD)|-0.5||||0.21|2-Sided|95.0|-2.2|1.2|||Regression, Linear||||
1619534|NCT02347787|2974859|Superiority||Risk Difference (RD)|-0.2||||0.21|2-Sided|95.0|-0.7|0.4|||Regression, Linear||||
1619535|NCT02347787|2974860|Superiority||Risk Difference (RD)|-0.2||||0.21|2-Sided|95.0|-1.3|0.9|||Regression, Linear||||
1619536|NCT02347787|2974861|Superiority|||||||0.3|||||||Regression, Linear|||Determination of targeted sample size was based on detecting a between-arm difference in mean change in SF-12 Physical Component Summary of 3 points, which is the minimal clinically significant difference for this instrument. To achieve at least 80% power with a type I error rate of 5%, we required 444 total participants. To account for 25% attrition, we aimed to accrue 592 participants.|
1619537|NCT02347774|2974876|Superiority||Least Mean Squared (SE)|0.084|Standard Error of the Mean|0.02069||0.0001|2-Sided|95.0|0.0433|0.1246||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least Mean Squared (SE)|||The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures model including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.|
1619538|NCT02347774|2974876|Superiority||Least Mean Squared (SE)|0.082|Standard Error of the Mean|0.02055|<|0.0001|2-Sided|95.0|0.0417|0.1224||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least Mean Squared (SE)|I||The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures model including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.|
1619539|NCT02347774|2974877|Superiority|A sample size of 215 subjects per treatment would give ~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Mean Squared (SE)|0.081|Standard Error of the Mean|0.02006||0.0001|2-Sided|95.0|0.0416|0.1204|||Least Mean Squared (SE)||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.|
1619562|NCT02347176|2974936|Superiority||Adjusted Mean Difference|-4.36|Standard Error of the Mean|1.951||0.027|2-Sided|95.0|-8.22|-0.51|||Mixed Model Repeated Measures Analysis||||
1620550|NCT02314546|2977582|Superiority or Other|||||||0.73|||||||Chi-squared||||
1619540|NCT02347774|2974877|Superiority|A sample size of 215 subjects per treatment would give ~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Mean Squared (SE)|0.0736|Standard Error of the Mean|0.01989||0.0002|2-Sided|95.0|0.0346|0.1127|||Least Mean Squared (SE)||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|The change from baseline in trough FEV1 was analyzed using a mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.|
1619541|NCT02347761|2974894|Superiority|In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|LS mean (SE)|0.1052|Standard Error of the Mean|0.0206|<|0.0001|2-Sided|95.0|0.0647|0.1457|||LS mean (SE)|||The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.|
1619542|NCT02347761|2974894|Superiority||Least Squares Mean (SE)|0.1264|Standard Error of the Mean|0.02076|<|0.0001|2-Sided|95.0|0.0856|0.1672||In order to control the family-wise Type I error rate, the Hochberg procedure (a tree-structured gatekeeping procedure) was used for comparisons of the primary efficacy endpoints and the key secondary efficacy endpoints.|Least squares mean (SE)|||The change from baseline in trough FEV1 was analyzed using mixed model repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit week, visit week by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.|
1619543|NCT02347761|2974895|Superiority|A sample size of 215 subjects per treatment would give ~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Squares Mean Difference (SE)|0.0961|Standard Error of the Mean|0.01896|<|0.0001|2-Sided|95.0|0.0589|0.1334||The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.|Mixed Model Repeat Measurement|to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of the endpoint.|Standard error of the least squares mean|The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.|
1619544|NCT02347761|2974895|Superiority|A sample size of 215 subjects per treatment would give ~ 90% power to detect a treatment difference of 80 mL in the change from baseline in trough FEV1 at Week 12 between each of the 2 SUN-101 dose groups and placebo at alpha= 0.05, assuming a standard deviation of 255 mL and using a 2-sided test.|Least Squares Mea Difference (SE)|0.1036|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.0663|0.1409||The primary null hypothesis for this study is that the mean change from baseline in trough FEV1 at Week 12 for the SUN-101 50 mcg dose is equal to the mean change from baseline in trough FEV1 at Week 12 for Placebo.|MMixed Model Repeat Measurement|to control the family-wise Type I error rate,the Hochberg procedure(a tree-structured gatekeeping procedure)was used for comparisons of this endpoint|standard error of the least squares mean|The change from baseline in trough FEV1 was analyzed using a mixed model for repeated measures including terms for treatment, cardiovascular risk, background LABA use, visit, visit by treatment interaction, and baseline FEV1 as a covariate. An unstructured covariance matrix was used.|
1619545|NCT02347657|2974903|Superiority||LS mean difference|0.06||||0.4127|2-Sided|95.0|-0.08|0.19|||MMRM|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.|
1619546|NCT02347657|2974904|Superiority||Event Rate Ratio|0.65||||0.0054|2-Sided|95.0|0.48|0.88|||Negative Binomial Regression|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.|
1619547|NCT02347657|2974905|Superiority||LS mean difference|6.8|||<|0.0001|2-Sided|95.0|5.3|8.3|||MMRM|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.|
1619548|NCT02347657|2974906|Superiority||Least Squares (LS) Mean Difference|4.0|||<|0.0001|2-Sided|95.0|3.1|4.8|||Mixed model for repeated measures (MMRM)|||Testing was performed according to the hierarchical testing procedure to control the overall type I error for tested at α = 0.05.|
1619549|NCT02347605|2974907|Superiority|||||||0.18||||||Adjusted for treatment order, session, room sequence|Mixed Models Analysis||||
1619550|NCT02347605|2974908|Superiority|||||||0.25||||||Adjusted for treatment order, session, room sequence|Mixed Models Analysis||||
1619551|NCT02347488|2974912|Superiority or Other||Mean Difference (Final Values)|3.1|Standard Deviation|1.8|<|0.001|2-Sided|95.0|2.88|3.32|||ANCOVA|||Average displacement difference in cm, tape vs. tube-holder. 17 participants was the estimated enrollment needed to detect a difference of 1 SD from the mean between the 2 fixation techniques at 80% power; additional enrollment was included to increase the power of results and to include a larger variety of patients undergoing different surgical procedures.|
1619552|NCT02347345|2974915|Other|Descriptive pilot study. Not relevant.||||||0.07|||||||Kruskal-Wallis||||
1619553|NCT02347332|2974916|Superiority|||||||0.6289||||||Threshold significance value p<0.05|Log Rank||||
1619554|NCT02347332|2974917|Superiority|||||||0.243||||||Threshold significance value p<0.05|Log Rank||||
1619555|NCT02347332|2974918|Superiority|||||||0.467||||||Threshold significance value p<0.05|Log Rank||||
1619556|NCT02347332|2974919|Superiority|||||||0.3576||||||Threshold significance value p<0.05|Log Rank||||
1619557|NCT02347332|2974920|Superiority|||||||0.8329||||||Threshold significance value p<0.05|Log Rank||||
1619558|NCT02347176|2974935|Superiority||Odds Ratio (OR)|2.83||||0.061|2-Sided|95.0|0.95|8.37|||Regression, Logistic||||
1619559|NCT02347176|2974935|Superiority||Odds Ratio (OR)|1.85||||0.281|2-Sided|95.0|0.61|5.65|||Regression, Logistic||||
1619563|NCT02347176|2974936|Superiority||Adjusted Mean Difference|-2.89|Standard Error of the Mean|1.968||0.143|2-Sided|95.0|-6.78|0.99|||Mixed Model Repeated Measures Analysis||||
1619564|NCT02347124|2974937|Superiority||Odds Ratio (OR)|0.07||||0.45|2-Sided|95.0|-0.11|0.26|||Regression, Linear|Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medication.|||
1619565|NCT02347124|2974938|Superiority||Odds Ratio (OR)|-0.02||||0.8|2-Sided|95.0|-0.2|0.16|||Regression, Linear|Adjusted for sex, age, state quit line, baseline self-efficacy score, baseline cigarettes per day, and baseline use of stop smoking medications.|||
1619566|NCT02347124|2974939|Superiority||Odds Ratio (OR)|0.02||||0.82|2-Sided|95.0|-0.17|0.21|||Regression, Linear||||
1619567|NCT02347124|2974940|Superiority||Odds Ratio (OR)|0.22||||0.02|2-Sided|95.0|0.04|0.41|||Regression, Linear|adjusted for sex, age, state quit line, and baseline motivation score.|||
1619568|NCT02347124|2974941|Superiority||Odds Ratio (OR)|-0.02||||0.83|2-Sided|95.0|-0.16|0.13|||Regression, Linear|Adjusted for sex, age, state quit line, use of a smoking cessation medication at baseline, baseline motivation score, and baseline cigarettes per day.|||
1619569|NCT02347124|2974942|Superiority||Odds Ratio (OR)|-0.1||||0.16|2-Sided|95.0|-0.24|0.04|||Regression, Linear|Adjusted for sex, age, state quit line, use of stop-smoking medications, baseline motivation, and baseline cigarettes per day.|||
1619570|NCT02347124|2974943|Superiority||Odds Ratio (OR)|0.0||||0.97|2-Sided|95.0|-0.22|0.23||Adjusted for sex, age, state quit line, and baseline self-efficacy score.|Regression, Linear||||
1619571|NCT02347124|2974944|Superiority||Odds Ratio (OR)|0.35||||0.002|2-Sided|95.0|0.13|0.56|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline self-efficacy score.|||
1619572|NCT02347124|2974945|Superiority||Odds Ratio (OR)|0.41||||0.14|2-Sided|95.0|-0.14|0.96|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline knowledge score.|||
1619573|NCT02347124|2974946|Superiority||Odds Ratio (OR)|-0.05||||0.85|2-Sided|95.0|-0.57|0.47|||Regression, Linear|Adjusted for sex, age, state quit line, and baseline knowledge score.|||
1619574|NCT02347124|2974947|Superiority||Odds Ratio (OR)|1.37||||0.09|2-Sided|95.0|0.95|1.96||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic||||
1619575|NCT02347124|2974948|Superiority||Odds Ratio (OR)|1.42||||0.04|2-Sided|95.0|1.01|2.0||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic||||
1619576|NCT02347124|2974949|Superiority||Odds Ratio (OR)|1.22||||0.21|2-Sided|95.0|0.89|1.69||Model is adjusted for sex, age, cigarettes per day at baseline, depression, self-efficacy, motivation, self-reported use of a stop smoking medication at baseline, and stratification variables state quit line and dental insurance.|Regression, Logistic||||
1619577|NCT02347124|2974950|Superiority||Odds Ratio (OR)|1.03||||0.9|2-Sided|95.0|0.69|1.53||Adjusted for baseline sex, age, depression history, motivation, self-efficacy, state quitline, and dental insurance.|Regression, Logistic||||
1619578|NCT02347124|2974951|Superiority||Odds Ratio (OR)|1.29||||0.13|2-Sided|95.0|0.93|1.78||Adjusted for baseline sex, age, cigarettes per day, depression history, motivation, self-efficacy, current use of a stop-smoking medication, state quitline, and dental insurance.|Regression, Logistic||||
1619579|NCT02347098|2974952|Superiority|||||||0.2663|||||||Fisher Exact||||
1619580|NCT02347098|2974953|Superiority|||||||0.4549||||||The p-value reported compares the trends of outcome across time (baseline pre-PCI, baseline post-PCI, 30-day follow-up, and 90-day follow-up) between treatment groups using the repeated measurement analysis.|Mixed Models Analysis||||
1619581|NCT02347098|2974954|Superiority|||||||0.779|||||||t-test, 2 sided||||
1619582|NCT02347098|2974955|Superiority|||||||0.2533|||||||t-test, 2 sided||||
1619583|NCT02346240|2975007|Superiority||Odds Ratio (OR)|49.527|||<|0.0001|2-Sided|95.0|10.002|245.256||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619584|NCT02346240|2975007|Superiority||Odds Ratio (OR)|72.278|||<|0.0001|2-Sided|95.0|14.65|356.602||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619585|NCT02346240|2975007|Superiority||Estimated difference in responder rate|39.5|||<||2-Sided|95.0|25.58|53.38|||||Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619586|NCT02346240|2975007|Superiority||Estimated difference in responder rate|48.8|||<||2-Sided|95.0|34.22|63.41|||||Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619587|NCT02346240|2975008|Superiority||Odds Ratio (OR)|27.165|||<|0.0001|2-Sided|95.0|6.504|113.453||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619655|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.27|Standard Error of the Mean|0.14||0.058|2-Sided|95.0|-0.54|0.01|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 45-48||
1619656|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.25|Standard Error of the Mean|0.144||0.078|2-Sided|95.0|-0.54|0.03|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 41-44||
1619588|NCT02346240|2975008|Superiority||Odds Ratio (OR)|40.717|||<|0.0001|2-Sided|95.0|9.741|170.198||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619589|NCT02346240|2975008|Superiority||Estimated difference in responder rate|44.9|||<||2-Sided|95.0|35.39|54.49|||||Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619590|NCT02346240|2975008|Superiority||Estimated difference in responder rate|55.0|||<||2-Sided|95.0|45.59|64.35|||||Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619591|NCT02346240|2975009|Superiority||Odds Ratio (OR)|55.413|||<|0.0001|2-Sided|95.0|13.135|233.782||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619592|NCT02346240|2975009|Superiority||Odds Ratio (OR)|76.277|||<|0.0001|2-Sided|95.0|17.952|324.094||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619593|NCT02346240|2975009|Superiority||Estimated difference in responder rate|64.4|||<||2-Sided|95.0|55.12|73.63|||||Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619594|NCT02346240|2975009|Superiority||Estimated difference in responder rate|70.9|||<||2-Sided|95.0|62.15|79.59|||||Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619595|NCT02346240|2975010|Superiority||Odds Ratio (OR)|35.084|||<|0.0001|2-Sided|95.0|7.363|167.179||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619596|NCT02346240|2975010|Superiority||Odds Ratio (OR)|39.949|||<|0.0001|2-Sided|95.0|8.407|189.828||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619597|NCT02346240|2975010|Superiority||Estimated difference in responder rate|31.0|||<||2-Sided|95.0|18.18|43.8|||||Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619598|NCT02346240|2975010|Superiority||Estimated difference in responder rate|33.8|||<||2-Sided|95.0|20.68|46.98|||||Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619599|NCT02346240|2975011|Superiority||Odds Ratio (OR)|36.566|||=|0|2-Sided|95.0|5.061|264.196||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619600|NCT02346240|2975011|Superiority||Odds Ratio (OR)|56.129|||<|0.0001|2-Sided|95.0|7.787|404.555||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619601|NCT02346240|2975011|Superiority||Estimated difference in responder rate|37.9|||<||2-Sided|95.0|28.88|46.96|||||Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619602|NCT02346240|2975011|Superiority||Estimated difference in responder rate|48.5|||<||2-Sided|95.0|39.33|57.63|||||Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619603|NCT02346240|2975012|Superiority||Odds Ratio (OR)|1.388|||=|0|2-Sided|95.0|0.886|2.175||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. ETN|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619657|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.11|Standard Error of the Mean|0.138||0.417|2-Sided|95.0|-0.38|0.16|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 37-40||
1619604|NCT02346240|2975012|Superiority||Odds Ratio (OR)|1.756|||=|0|2-Sided|95.0|1.114|2.768||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. ETN.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619605|NCT02346240|2975012|Superiority||Estimated difference in responder rate|8.0|||=||2-Sided|95.0|-2.9|18.9|||||Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Etanercept Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619606|NCT02346240|2975012|Superiority||Estimated difference in responder rate|13.4|||=||2-Sided|95.0|2.7|24.1|||||Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Etanercept Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619607|NCT02346240|2975012|Superiority||Odds Ratio (OR)|30.023|||<|0.0001|2-Sided|95.0|8.971|100.481||The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619608|NCT02346240|2975012|Superiority||Odds Ratio (OR)|37.988|||<|0.0001|2-Sided|95.0|11.312|127.576||The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO.|Regression, Logistic|Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619609|NCT02346240|2975012|Superiority||Estimated difference in responder rate|56.2|||<||2-Sided|95.0|46.4|66.0|||||Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619610|NCT02346240|2975012|Superiority||Estimated difference in responder rate|61.6|||<||2-Sided|95.0|52.1|71.2|||||Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1619611|NCT02346136|2975013|Superiority||Mean Difference (Net)|1.27|Standard Error of the Mean|0.81||0.13|2-Sided|95.0|-0.4|2.94|||Mixed Models Analysis||||
1619612|NCT02346136|2975014|Superiority||Risk Ratio (RR)|0.476||||0.06|2-Sided|95.0|0.216|1.05|||Mixed Models Analysis|Mixed model Poisson reg with fixed effects of age, baseline SPPB, baseline CES-D, and falls in prev year and random intercept and trt by site pair|Numerator of risk ratio is the rate among participants at sites receiving Tai Chi. Denominator of risk ratio is the rate among participants at sites receiving Health Education.||
1619613|NCT02346136|2975016|Superiority||Mean Difference (Net)|2.14|Standard Error of the Mean|2.56||0.41|2-Sided|95.0|-2.98|7.26||to accommodate two co-primary outcomes|Mixed Models Analysis||||
1619614|NCT02346136|2975017|Superiority||Median Difference (Net)|0.4|Standard Error of the Mean|1.0||0.69|2-Sided|95.0|-1.6|2.41|||Mixed Models Analysis||||
1619615|NCT02346136|2975018|Superiority||Mean Difference (Net)|-1.1|Standard Error of the Mean|1.66||0.51|2-Sided|95.0|-4.41|2.21|||Mixed Models Analysis|||Mental component score|
1619616|NCT02346136|2975018|Superiority||Mean Difference (Net)|0.85|Standard Error of the Mean|1.43||0.55|2-Sided|95.0|-2.0|3.71|||Mixed Models Analysis|||Physical component score|
1619617|NCT02346136|2975019|Superiority||Median Difference (Net)|1.36|Standard Error of the Mean|9.28||0.88|2-Sided|95.0|-17.2|19.9|||Mixed Models Analysis||||
1619618|NCT02346136|2975020|Superiority||Median Difference (Net)|0.72|Standard Error of the Mean|7.29||0.92|2-Sided|95.0|-13.9|15.3|||Mixed Models Analysis||||
1619619|NCT02346136|2975021|Superiority||Mean Difference (Net)|0.81|Standard Error of the Mean|0.71||0.26|2-Sided|95.0|-0.61|2.22|||Mixed Models Analysis||||
1619620|NCT02346136|2975022|Superiority||Mean Difference (Net)|-0.004|Standard Error of the Mean|0.02||0.84|2-Sided|95.0|-0.04|0.03|||Mixed Models Analysis||||
1619621|NCT02346136|2975023|Superiority||Mean Difference (Net)|0.02|Standard Error of the Mean|0.02||0.26|2-Sided|95.0|-0.02|0.06|||Mixed Models Analysis|||Gait DT velocity variable|
1619622|NCT02346136|2975023|Superiority||Mean Difference (Net)|0.0|Standard Error of the Mean|0.02||0.85|2-Sided|95.0|-0.04|0.05|||Mixed Models Analysis|||Gait NW velocity variable|
1619623|NCT02346136|2975024|Superiority||Mean Difference (Net)|-0.65|Standard Error of the Mean|0.94||0.5|2-Sided|95.0|-2.53|1.24|||Mixed Models Analysis||||
1619624|NCT02346136|2975025|Superiority||Risk Ratio (RR)|0.535||||0.194|2-Sided|95.0|0.182|1.57|||Mixed Models Analysis|Mixed model Poisson reg with fixed effects of age, baseline SPPB, baseline CES-D, and falls in prev year and random intercept and trt by site pair|Numerator of risk ratio is the rate among participants at sites receiving Tai Chi. Denominator of risk ratio is the rate among participants at sites receiving Health Education.||
1619625|NCT02346136|2975026|Superiority||Mean Difference (Net)|-0.12|Standard Error of the Mean|0.25||0.62|2-Sided|95.0|-0.62|0.37||Tested as two-tailed p<0.025 to accommodate two co-primary outcomes|Mixed Models Analysis||||
1619626|NCT02345486|2975079|Superiority||Mean Difference (Final Values)|0.7||||0.001|2-Sided|95.0|0.66|0.74|||Wilcoxon (Mann-Whitney)||"reported mean difference is a difference in proportions."||
1619627|NCT02345252|2975107|Superiority|||||||1|||||||Fisher Exact||||
1619658|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.17|Standard Error of the Mean|0.14||0.239|2-Sided|95.0|-0.44|0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 33-36||
1619659|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.2|Standard Error of the Mean|0.136||0.138|2-Sided|95.0|-0.47|0.07|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 29-32||
1619896|NCT02338193|2975799|Superiority||||||<|0.032|||||||ANOVA|||One Way ANOVA with Bonferroni contrast if p>0.05|
1619628|NCT02345252|2975107|Non-Inferiority|A sample size of 275 HIV-1 infected participants per treatment group would provide 85% power to detect a noninferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and FTC/RPV/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.|Difference in Percentages|-0.3|||||2-Sided|95.001|-4.2|3.7|||||The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the FTC/RPV/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA < 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the FTC/RPV/TDF group.|
1619629|NCT02345226|2975119|Superiority|||||||0.35|||||||Fisher Exact||||
1619630|NCT02345226|2975119|Non-Inferiority|A sample size of 400 HIV-1 infected participants per treatment group would provide 95% power to detect a non-inferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and EFV/FTC/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89% (based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.|Difference in Percentages|-2.0|||||2-Sided|95.001|-5.9|1.8|||||The difference in percentages and its 95.001% confidence interval (CI) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.|The null hypothesis was that the percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the EFV/FTC/TDF group; the alternative hypothesis was that the percentage of participants with HIV-1 RNA < 50 copies/mL in the FTC/RPV/TAF group was less than 8% lower than that in the EFV/FTC/TDF group.|
1619631|NCT02345161|2975140|Superiority or Other||LS mean difference|2.6|Standard Error of the Mean|0.96||0.007|2-Sided|95.0|0.7|4.5|||Mixed Model Repeated Measures||||
1619632|NCT02345161|2975141|Superiority or Other||LS mean difference|0.3|Standard Error of the Mean|0.45||0.526|2-Sided|95.0|-0.6|1.2|||Mixed Model Repeated Measures||||
1619633|NCT02345161|2975143|Superiority or Other||LS mean difference|-0.9|Standard Error of the Mean|0.75||0.253|2-Sided|95.0|-2.3|0.6|||Mixed Model Repeated Measures||Week 52, DBP||
1619634|NCT02345161|2975143|Superiority or Other||: LS mean difference|-1.6|Standard Error of the Mean|1.19||0.183|2-Sided|95.0|-3.9|0.8|||Mixed Model Repeated Measures||Week 52, SBP||
1619635|NCT02345161|2975144|Superiority or Other||LS mean difference|0.2|Standard Error of the Mean|0.38||0.613|2-Sided|95.0|-0.6|0.9|||Mixed Model Repeated Measures||Week 24, DBP||
1619636|NCT02345161|2975144|Superiority or Other||LS mean difference|0.1|Standard Error of the Mean|0.56||0.849|2-Sided|95.0|-1.0|1.2|||Mixed Model Repeated Measures||Week 24, SBP||
1619637|NCT02345161|2975147|Superiority or Other||LS mean difference|0.2|Standard Error of the Mean|1.57||0.908|2-Sided|95.0|-2.9|3.3|||Mixed Model Repeated Measures||For PR interval||
1619638|NCT02345161|2975147|Superiority or Other||LS mean difference|-1.1|Standard Error of the Mean|1.83||0.564|2-Sided|95.0|-4.7|2.5|||Mixed Model Repeated Measures||For QTcF||
1619639|NCT02345161|2975148|Superiority or Other||LS mean difference|-0.6|Standard Error of the Mean|0.78||0.471|2-Sided|95.0|-2.1|1.0|||Mixed Model Repeated Measures||For PR interval||
1619640|NCT02345161|2975148|Superiority or Other||LS mean difference|1.8|Standard Error of the Mean|0.81||0.023|2-Sided|95.0|0.3|3.4|||Mixed Model Repeated Measures||For QTcF||
1619641|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.41|Standard Error of the Mean|0.163||0.013|2-Sided|95.0|-0.73|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 49-52||
1619642|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.45|Standard Error of the Mean|0.16||0.006|2-Sided|95.0|-0.76|-0.13|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 45-48||
1619643|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.42|Standard Error of the Mean|0.153||0.007|2-Sided|95.0|-0.72|-0.12|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 41-44||
1619644|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.37|Standard Error of the Mean|0.151||0.014|2-Sided|95.0|-0.67|-0.07|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 37-40||
1619645|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.4|Standard Error of the Mean|0.157||0.011|2-Sided|95.0|-0.71|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 33-36||
1619646|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.39|Standard Error of the Mean|0.152||0.011|2-Sided|95.0|-0.68|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 29-32||
1619647|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.41|Standard Error of the Mean|0.148|||2-Sided|95.0|-0.7|-0.12|||||Chest EXACT-RS score, Week 25-28||
1619648|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.37|Standard Error of the Mean|0.144||0.01|2-Sided|95.0|-0.66|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 21-24||
1619649|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.38|Standard Error of the Mean|0.146||0.01|2-Sided|95.0|-0.67|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 17-20||
1619650|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.3|Standard Error of the Mean|0.136||0.027|2-Sided|95.0|-0.57|-0.03|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 13-16||
1619651|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.27|Standard Error of the Mean|0.131||0.042|2-Sided|95.0|-0.53|-0.01|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 9-12||
1619652|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.32|Standard Error of the Mean|0.118||0.006|2-Sided|95.0|-0.56|-0.09|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 5-8||
1619653|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.18|Standard Error of the Mean|0.097||0.068|2-Sided|95.0|-0.37|0.01|||Mixed Model Repeated Measures||Chest EXACT-RS score, Week 1-4||
1619654|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.17|Standard Error of the Mean|0.141||0.231|2-Sided|95.0|-0.45|0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 49-52||
1619660|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.17|Standard Error of the Mean|0.137||0.218|2-Sided|95.0|-0.44|0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 25-28||
1619661|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.12|Standard Error of the Mean|0.138||0.388|2-Sided|95.0|-0.39|0.15|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 21-24||
1619662|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.09|Standard Error of the Mean|0.134||0.49|2-Sided|95.0|-0.36|0.17|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 17-20||
1619663|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.11|Standard Error of the Mean|0.124||0.36|2-Sided|95.0|-0.36|0.13|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 13-16||
1619664|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.11|Standard Error of the Mean|0.117||0.359|2-Sided|95.0|-0.34|0.12|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 9-12||
1619665|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.15|Standard Error of the Mean|0.106||0.167|2-Sided|95.0|-0.36|-0.06|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 5-8||
1619666|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.02|Standard Error of the Mean|0.091||0.84|2-Sided|95.0|-0.2|0.16|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS score, Week 1-4||
1619667|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.87|Standard Error of the Mean|0.294||0.003|2-Sided|95.0|-1.45|-0.3|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 49-52EXA||
1619668|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.85|Standard Error of the Mean|0.299||0.004|2-Sided|95.0|-1.44|-0.27|||Breathlessness score, Week 41-44||Breathlessness EXACT-RS score, Week 45-48||
1619669|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.82|Standard Error of the Mean|0.294||0.006|2-Sided|95.0|-1.4|-0.24|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 41-44||
1619670|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.76|Standard Error of the Mean|0.287||0.008|2-Sided|95.0|-1.32|-0.2|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 37-40||
1619671|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.95|Standard Error of the Mean|0.288||0.001|2-Sided|95.0|-1.51|-0.38|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 33-36||
1619672|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.85|Standard Error of the Mean|0.276||0.002|2-Sided|95.0|-1.4|-0.31|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 29-32||
1619673|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.76|Standard Error of the Mean|0.275||0.006|2-Sided|95.0|-1.3|-0.21|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 25-28||
1619674|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.64|Standard Error of the Mean|0.268||0.018|2-Sided|95.0|-1.16|-0.11|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 21-24||
1619675|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.67|Standard Error of the Mean|0.265||0.012|2-Sided|95.0|-1.19|-0.15|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 17-20||
1619676|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.62|Standard Error of the Mean|0.247||0.013|2-Sided|95.0|-1.1|-0.13|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 13-16||
1619677|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.61|Standard Error of the Mean|0.234||0.01|2-Sided|95.0|-1.07|-0.15|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 9-12||
1619678|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.61|Standard Error of the Mean|0.207||0.003|2-Sided|95.0|-1.02|-0.2|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 5-8||
1619679|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.33|Standard Error of the Mean|0.169||0.051|2-Sided|95.0|-0.66|0.0|||Mixed Model Repeated Measures||Breathlessness EXACT-RS score, Week 1-4||
1619680|NCT02345161|2975157|Superiority or Other||LS Mean difference|-1.42|Standard Error of the Mean|0.524||0.007|2-Sided|95.0|-2.45|-0.39|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 49-52||
1619681|NCT02345161|2975157|Superiority or Other||LS Mean difference|-1.53|Standard Error of the Mean|0.525||0.007|2-Sided|95.0|-2.56|-0.5|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 45-49||
1619682|NCT02345161|2975157|Superiority or Other||LS Mean difference|-1.49|Standard Error of the Mean|0.513||0.04|2-Sided|95.0|-2.5|-0.48|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 41-44||
1619683|NCT02345161|2975157|Superiority or Other||LS Mean difference|-1.23|Standard Error of the Mean|0.507||0.016|2-Sided|95.0|-2.22|-0.23|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 37-40||
1619684|NCT02345161|2975157|Superiority or Other||LS Mean difference|-1.5|Standard Error of the Mean|0.519||0.004|2-Sided|95.0|-2.52|-0.48|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 33-36||
1619685|NCT02345161|2975157|Superiority or Other||LS Mean difference|-1.43|Standard Error of the Mean|0.494||0.004|2-Sided|95.0|-2.4|-0.46|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 29-32||
1619686|NCT02345161|2975157|Superiority or Other||LS Mean difference|-1.32|Standard Error of the Mean|0.492||0.008|2-Sided|95.0|-2.29|-0.35|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 25-28||
1619687|NCT02345161|2975157|Superiority or Other||LS Mean difference|-1.11|Standard Error of the Mean|0.481||0.022|2-Sided|95.0|-2.05|-0.16|||Mixed Model Repeated Measures||EXACT-RS Score, Week 21-24||
1619688|NCT02345161|2975157|Superiority or Other||LS Mean difference|-1.11|Standard Error of the Mean|0.481||0.021|2-Sided|95.0|-2.06|-0.17|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 17-20||
1619689|NCT02345161|2975157|Superiority or Other||LS Mean difference|-1.01|Standard Error of the Mean|0.445||0.024|2-Sided|95.0|-1.88|-0.13|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 13-16||
1619690|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.97|Standard Error of the Mean|0.419||0.022|2-Sided|95.0|-1.79|-0.14|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 9-12||
1619691|NCT02345161|2975157|Superiority or Other||LS Mean difference|-1.07|Standard Error of the Mean|0.371||0.004|2-Sided|95.0|-1.8|-0.34|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 5-8||
1619692|NCT02345161|2975157|Superiority or Other||LS Mean difference|-0.52|Standard Error of the Mean|0.311||0.094|2-Sided|95.0|-1.13|0.09|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 1-4||
1619693|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.36|Standard Error of the Mean|0.072|<|0.001|2-Sided|95.0|-0.5|-0.22|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 21-24||
1619694|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.4|Standard Error of the Mean|0.071|<|0.001|2-Sided|95.0|-0.53|-0.26|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 17-20||
1619695|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.38|Standard Error of the Mean|0.068|<|0.001|2-Sided|95.0|-0.51|-0.25|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 13-16||
1619696|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.34|Standard Error of the Mean|0.066|<|0.001|2-Sided|95.0|-0.47|-0.21|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 9-12||
1619697|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.34|Standard Error of the Mean|0.06|<|0.001|2-Sided|95.0|-0.46|-0.23|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 5-8||
1619698|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.27|Standard Error of the Mean|0.049|<|0.001|2-Sided|95.0|-0.37|-0.18|||Mixed Model Repeated Measures||Chest EXACT-RS Scores, Week 1-4||
1619699|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.23|Standard Error of the Mean|0.065|<|0.001|2-Sided|95.0|-0.35|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 21-24||
1619700|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.24|Standard Error of the Mean|0.064|<|0.001|2-Sided|95.0|-0.36|-0.11|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 17-20||
1619701|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.22|Standard Error of the Mean|0.061|<|0.001|2-Sided|95.0|-0.34|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 13-16||
1619702|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.17|Standard Error of the Mean|0.058|<|0.004|2-Sided|95.0|-0.28|-0.05|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 9-12||
1619703|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.2|Standard Error of the Mean|0.053|<|0.001|2-Sided|95.0|-0.31|-0.1|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 5-8||
1619704|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.17|Standard Error of the Mean|0.044|<|0.001|2-Sided|95.0|-0.26|-0.09|||Mixed Model Repeated Measures||Cough and sputum EXACT-RS Score, Week 1-4||
1619705|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.77|Standard Error of the Mean|0.122|<|0.001|2-Sided|95.0|-1.01|-0.54|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 21-24||
1619706|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.79|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|-1.03|-0.56|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 17-20||
1619707|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.75|Standard Error of the Mean|0.115|<|0.001|2-Sided|95.0|-0.97|-0.52|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 13-16||
1619708|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.69|Standard Error of the Mean|0.108|<|0.001|2-Sided|95.0|-0.9|-0.48|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 9-12||
1619709|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.69|Standard Error of the Mean|0.098|<|0.001|2-Sided|95.0|-0.88|-0.5|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 5-8||
1619710|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.52|Standard Error of the Mean|0.08|<|0.001|2-Sided|95.0|-0.67|-0.36|||Mixed Model Repeated Measures||Breathlessness EXACT-RS Score, Week 1-4||
1619711|NCT02345161|2975158|Superiority or Other||Mixed Model Repeated Measures|-1.35|Standard Error of the Mean|0.224|<|0.001|2-Sided|95.0|-1.79|-0.91|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 21-24||
1619712|NCT02345161|2975158|Superiority or Other||LS Mean difference|-1.41|Standard Error of the Mean|0.223|<|0.001|2-Sided|95.0|-1.85|-0.97|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 17-20||
1619713|NCT02345161|2975158|Superiority or Other||LS Mean difference|-1.33|Standard Error of the Mean|0.213|<|0.001|2-Sided|95.0|-1.75|-0.91|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 13-16||
1619714|NCT02345161|2975158|Superiority or Other||LS Mean difference|-1.18|Standard Error of the Mean|0.201|<|0.001|2-Sided|95.0|-1.57|-0.78|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 9-12||
1619715|NCT02345161|2975158|Superiority or Other||LS Mean difference|-1.23|Standard Error of the Mean|0.183|<|0.001|2-Sided|95.0|-1.59|-0.87|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 5-8||
1619716|NCT02345161|2975158|Superiority or Other||LS Mean difference|-0.95|Standard Error of the Mean|0.15|<|0.001|2-Sided|95.0|-1.25|-0.66|||Mixed Model Repeated Measures||EXACT-RS Scores, Week 1-4||
1619717|NCT02345161|2975159|Superiority or Other||Rate ratio|0.56||||0.006|2-Sided|95.0|0.37|0.85|||Generalized Linear model|Generalized linear model assuming a negative binomial distribution|||
1619718|NCT02345161|2975160|Superiority or Other||Rate ratio|0.65||||0.002|2-Sided|95.0|0.49|0.86|||Generalized linear modeL|Generalized linear model assuming a negative binomial distribution|||
1619719|NCT02345161|2975161|Superiority or Other||LS Mean difference|-0.3|Standard Error of the Mean|0.95||0.767|2-Sided|95.0|-2.1|1.6|||ANCOVA||||
1619720|NCT02345161|2975162|Superiority or Other||LS Mean difference|0.1|Standard Error of the Mean|0.51||0.817|2-Sided|95.0|-0.9|1.1|||ANCOVA||||
1619721|NCT02345161|2975163|Superiority or Other||LS Mean difference|0.34|Standard Error of the Mean|0.317||0.279|2-Sided|95.0|-0.28|0.97|||Mixed effect repeated measures model||||
1619722|NCT02345161|2975164|Superiority or Other||LS Mean difference|0.57|Standard Error of the Mean|0.138|<|0.001|2-Sided|95.0|0.3|0.84|||Mixed effect repeated measures model||||
1619723|NCT02345161|2975165|Superiority or Other||Adjusted LS mean difference|-2.7|Standard Error of the Mean|1.44||0.065|2-Sided|95.0|-5.5|0.2|||Mixed Model Repeated Measures||||
1619724|NCT02345161|2975166|Superiority or Other||Adjusted LS mean difference|-2.2|Standard Error of the Mean|0.64|<|0.001|2-Sided|95.0|-3.5|-1.0|||Mixed Model Repeated Measures||||
1619725|NCT02345161|2975167|Superiority or Other||Adjusted LS mean difference|0.179|Standard Error of the Mean|0.0242|<|0.001|2-Sided|95.0|0.131|0.226|||Mixed Model Repeated Measures||||
1619726|NCT02345161|2975168|Superiority or Other||Adjusted LS mean difference|0.171|Standard Error of the Mean|0.0118|<|0.001|2-Sided|95.0|0.148|0.194|||Mixed Model Repeated Measures||||
1619784|NCT02341599|2975436|Other|LS mean ratio of Group E: Period 2/Group A|LS mean ratio|0.326|||||2-Sided|90.0|0.265|0.402|||||LS mean ratio was calculated from ANOVA model.||
1619727|NCT02345070|2975171|Superiority|The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|LS Mean Difference|0.56|Standard Error of the Mean|1.04|=|0|2-Sided|95.0|-1.47|2.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||SAR156597 200mg q2w versus Placebo qw|A hierarchical testing procedure was used to control type I error. Testing was performed sequentially in the order outcome measures were reported (q2w dose group compared to placebo). Analysis was performed using MMRM with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of percent predicted FVC baseline.|
1619728|NCT02345070|2975171|Superiority|The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|Least Square (LS) Mean Difference|-0.5|Standard Error of the Mean|1.05|=|0|2-Sided|95.0|-2.56|1.56||Threshold for significance at 0.05 level.|Mixed Models Analysis||SAR156597 200mg qw versus Placebo qw|A hierarchical testing procedure was used to control type I error. Testing was done sequentially in order the outcome measures were reported. Analyzed using Mixed Model for Repeated Measurements (MMRM) with fixed categorical effects of treatment arm, stratification factor (with/without background therapy), time point, treatment-by-time point interaction, stratification factor-by-treatment-by-time point interaction, and continuous fixed covariate of percent predicted FVC baseline.|
1619729|NCT02344745|2975177|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1619730|NCT02344745|2975178|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1619731|NCT02344745|2975179|Superiority or Other|||||||0.7|||||||Wilcoxon (Mann-Whitney)||||
1619732|NCT02344745|2975180|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1619733|NCT02344407|2975200|Superiority||||||<|0.001|||||||ANCOVA|Analysis of covariance adjusting for baseline antibody level|||
1619734|NCT02344407|2975200|Superiority||||||<|0.001|||||||ANCOVA|Linear regression (analysis of covariance) adjusted for baseline antibody level|||
1619735|NCT02344407|2975201|Superiority|||||||0.68|||||||Chi-squared|Barnard Exact Test Chi-square|||
1619736|NCT02344407|2975201|Superiority|||||||0.68|||||||Chi-squared|Bernards Exact Test Chi-square||Each active vaccine is compared to the placebo group|
1619737|NCT02344004|2975219|Superiority||Cox Proportional Hazard|3.92|||<|0.0001|2-Sided|95.0|2.01|7.63|||Regression, Cox|||Kaplan Meier estimates for the distribution of time to culture conversion were constructed for treatment arms. The treatment comparison was made using the stratified log rank test for the ITT population. The estimated median time to culture conversion for each treatment arm was not estimable. The time to culture conversion was analyzed using Cox regression model to estimate hazards ratio.|
1619738|NCT02344004|2975220|Superiority|||||||0.7804|||||||Mixed Model Repeated Measures (MMRM)|||This was analyzed using a mixed model repeated measures (MMRM) analysis of change from Baseline at Months 4&6. MMRM included treatment, month, treatment-by-month interaction, combination of smoking status & prior MDR (4 levels: Yes/Yes, Yes/No, No/Yes, and No/No) as fixed factors, baseline 6MWD as a covariate & baseline 6MWD-by-month interaction. An unstructured covariance matrix was used for the MMRM.|"Baseline is defined as the last non-missing value prior to first dose of study drug.~Statistics were obtained from an mixed-effects model repeated measures (MMRM) model with pattern-mixture modeling of missing values due to dropout, which included treatment, month, the treatment-by-month interaction, and the combination of smoking status and prior multidrug regimen as fixed factors, the baseline 6MWT distance as a covariate and baseline 6MWT distance-by-month interaction. MMRM included postbaseline data through Month 6.~For baseline, n is the number of participants with a baseline score and at least 1 postbaseline score. For Month 6, n is the number of participants with a baseline score and a postbaseline score at the summarized visit."
1619739|NCT02344004|2975221|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1619740|NCT02344004|2975222|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||The proportion of participants achieving culture conversion by Month 6 was analyzed using the Cochran-Mantel-Haenszel test, stratified by smoking status and prior multi-drug regimen. The treatment comparison was tested at two-sided significance level of 0.05. The null hypothesis assumed that culture conversion by Month 6 is independent of treatment, and the alternative hypothesis assumed that culture conversion by Month 6 is associated with treatment.|The final analysis of the primary endpoint, the number of participants achieving culture conversion at by Month 6, was performed after the last participants completed Month 6 and his/her Month 6 sputum culture result was available.
1619741|NCT02343406|2975263|Other||Cox Proportional Hazard|0.88|||=|0|2-Sided|95.0|0.52|1.49||2-sided|Log Rank||||
1619742|NCT02343406|2975263|Other||Cox Proportional Hazard|0.67|||=|0|2-Sided|95.0|0.4|1.13||2-sided|Log Rank||||
1619743|NCT02343406|2975264|Other||Odds Ratio (OR)|1.21|||=|0|2-Sided|95.0|0.12|12.49||2-sided|Cochran-Mantel-Haenszel|||Comparison is based on Cochran-Mantel-Haenszel method with stratification factors. Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, > 0), timing of relapse (< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).|
1619744|NCT02343406|2975264|Other||Odds Ratio (OR)|3.1|||=|0|2-Sided|95.0|0.6|16.16||2-sided|Cochran-Mantel-Haenszel|||Comparison is based on Cochran-Mantel-Haenszel method with stratification factors. Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, > 0), timing of relapse (< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).|
1619745|NCT02343406|2975272|Other||Cox Proportional Hazard|1.31|||=|0|2-Sided|95.0|0.93|1.84||2-sided|Log Rank||||
1619746|NCT02343406|2975272|Other||Cox Proportional Hazard|0.77|||=|0|2-Sided|95.0|0.55|1.07||2-sided|Log Rank||||
1619747|NCT02343406|2975273|Other||Cox Proportional Hazard|1.04|||=|0|2-Sided|95.0|0.73|1.48||2-sided|Log Rank|||Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, > 0), timing of relapse (< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).|
1619748|NCT02343406|2975273|Other||Cox Proportional Hazard|0.71|||=|0|2-Sided|95.0|0.5|1.02||2-sided|Log Rank|||Stratified at randomization by regions of the world (North America, Europe and Australia, Asia/Other Regions), WHO performance status (0, > 0), timing of relapse (< 16 weeks, ≥ 16 weeks after first day of last TMZ cycle).|
1619749|NCT02343081|2975298|Non-Inferiority or Equivalence|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the means ratio for AUC0-inf for Temozolomide reference and test to fall within the 80-125% confidence range.|AUC0-inf|101.53|||<|0.05|2-Sided|90.0|98.6|104.54|||ANOVA||AUC0-inf Test/Reference Ratio||
1619750|NCT02343081|2975299|Non-Inferiority or Equivalence|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the means ratio for AUC0-t for Temozolomide reference and test to fall within the 80-125% confidence range.|AUC0-t|100.99|||<|0.05|2-Sided|90.0|97.81|104.28|||ANOVA||AUC0-t Test/Reference Ratio||
1619751|NCT02343081|2975303|Non-Inferiority or Equivalence|Assuming an intrasubject CV of 15%, an enrollment of 16 subjects was selected to provide a minimum of 80% power for the 90% CI of the ratio of the mean for Cmax for Temozolomide reference and test to fall within the 80–125% confidence range.|Cmax|94.37|||<|0.05|2-Sided|90.0|82.69|107.69|||ANOVA|Primary parameters were analyzed using ANOVA. A linear, mixed model for crossover designs (two-period, two-sequence, two-treatment) was used.|Cmax Test/Reference Ratio|Bioequivalence assessment was made for the 90% CI for the ratio of log transformed pharmacokinetic parameters μT / μR and with the two one-sided Schuirmann T-test procedure under the null hypothesis|
1619752|NCT02342886|2975310|Non-Inferiority|Non-inferiority was assessed using the upper bound of the two-sided 95% CI for the difference between the percentage of patients who are classified as having an unfavourable status on the intervention (6 months moxifloxacin + 200 mg PA-824 + pyrazinamide) and the control regimen (2 months HRZE/ 4 months HR). The intervention was considered to be non-inferior to the control arm if the upper bound 95% CI was < 12%.|Treatment difference: unfavourable rate|6.62|||||2-Sided|95.0|-2.15|15.4|||||(DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide) - (DS-TB: 2 Months HRZE/ 4 Months HR).||
1619753|NCT02342886|2975311|Non-Inferiority|Non-inferiority was assessed using the upper bound of the two-sided 95% confidence interval (CI) for the difference between the percentage of patients who are classified as having an unfavourable status on the intervention (6 months moxifloxacin + 200 mg PA-824 + pyrazinamide) and the control regimen (2 months HRZE/ 4 months HR). The intervention was considered to be non-inferior to the control arm if the upper bound 95% CI was < 12%.|Treatment difference: unfavourable rate|9.88|||||2-Sided|95.0|-4.13|23.89|||||(DS-TB: 6 Months Moxifloxacin + PA-824 (200 mg) + Pyrazinamide) - (DS-TB: 2 Months HRZE/ 4 Months HR).||
1619754|NCT02342743|2975312|Superiority|||||||0.03||||||Threshold for statistical significance set to 0.05|Wilcoxon (Mann-Whitney)||||
1619755|NCT02342743|2975314|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1619756|NCT02342743|2975315|Superiority|||||||0.012||||||Threshold for statistical significance set to 0.05|Wilcoxon (Mann-Whitney)||||
1619757|NCT02342743|2975316|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1619758|NCT02342743|2975317|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1619759|NCT02342743|2975318|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1619760|NCT02342743|2975319|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1619761|NCT02342704|2975326|Superiority or Other|||||||0.2632|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups|||
1619762|NCT02342704|2975328|Superiority or Other|||||||0.0528|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||T2 Lesion Volume Change|
1619763|NCT02342704|2975328|Superiority or Other|||||||0.5318|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||T1 Lesion Volume Change|
1619764|NCT02342704|2975329|Superiority or Other|||||||0.0076|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 24|
1619765|NCT02342704|2975329|Superiority or Other|||||||0.0123|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 24|
1619766|NCT02342704|2975329|Superiority or Other|||||||0.0299|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 12|
1619767|NCT02342704|2975329|Superiority or Other|||||||0.0127|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 12|
1619768|NCT02342704|2975329|Superiority or Other|||||||0.3525|||||||negative binomial regression|p-value is based on negative binomial regression model, adjusted for baseline GD lesion count||Week 4|
1619769|NCT02342704|2975329|Superiority or Other|||||||0.126|||||||Wilcoxon rank-sum test|p-value is based on Wilcoxon rank-sum test between the 2 treatment groups||Week 4|
1619770|NCT02342678|2975331|Superiority||Mean Difference (Final Values)|0.2||||0.46|2-Sided|95.0|-0.4|0.9|||ANCOVA||||
1619771|NCT02342678|2975332|Superiority||Mean Difference (Final Values)|5.6||||0.24|2-Sided|95.0|-3.7|14.8|||ANCOVA||||
1619772|NCT02342678|2975333|Superiority||Mean Difference (Final Values)|-19.3||||0.38|2-Sided|95.0|-62.9|24.3|||ANCOVA||||
1619773|NCT02342678|2975334|Superiority||Mean Difference (Final Values)|0.1||||0.73|2-Sided|95.0|-0.3|0.4|||ANCOVA||||
1619774|NCT02342678|2975335|Superiority||Mean Difference (Final Values)|0.9||||0.13|2-Sided|95.0|-0.3|2.0|||ANCOVA||||
1619775|NCT02342678|2975336|Superiority||Mean Difference (Final Values)|0.1||||0.89|2-Sided|95.0|-1.2|1.3|||ANCOVA||||
1619776|NCT02342678|2975337|Superiority||Mean Difference (Final Values)|0.4||||0.18|2-Sided|95.0|-0.2|1.1|||ANCOVA||||
1619777|NCT02342678|2975338|Superiority||Mean Difference (Final Values)|0.9||||0.13|2-Sided|95.0|-0.3|2.2|||ANCOVA||||
1619778|NCT02342561|2975339|Superiority or Other|||||||0.731|||||||Fisher Exact|||Difference in prevalence of CoNs between the 2 groups was analysed. The null-hypothesis was no difference.|
1619779|NCT02342561|2975340|Superiority or Other|||||||0.823|||||||Wilcoxon (Mann-Whitney)|||After skin disinfection|
1619780|NCT02342561|2975340|Superiority or Other|||||||0.601|||||||Wilcoxon (Mann-Whitney)|||At end of surgery|
1619781|NCT02342418|2975353|Superiority or Other|||||||0.214|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pair signed-rank test|
1619782|NCT02342418|2975354|Superiority or Other|||||||0.314|||||||Wilcoxon (Mann-Whitney)||||
1619783|NCT02341599|2975436|Other|LS mean ratio of Group E: Period 2/Group E: Period 1|LS mean ratio|0.808|||||2-Sided|90.0|0.65|1.0|||||LS mean ratio was calculated from ANOVA model.||
1619785|NCT02341599|2975436|Other|LS mean ratio of Group E: Period 1/Group A|LS mean ratio|0.273|||||2-Sided|90.0|0.221|0.336|||||LS mean ratio was calculated from ANOVA model.||
1619786|NCT02341599|2975436|Other|LS mean ratio of Group D/Group A|LS mean ratio|0.678|||||2-Sided|90.0|0.554|0.831|||||LS mean ratio was calculated from ANOVA model.||
1619787|NCT02341599|2975436|Other|LS mean ratio of Group C/Group A|LS mean ratio|0.524|||||2-Sided|90.0|0.428|0.641|||||LS mean ratio was calculated from ANOVA model.||
1619788|NCT02341599|2975436|Other|LS mean ratio of Group B/Group A|LS mean ratio|1.04|||||2-Sided|90.0|0.846|1.27|||||LS mean ratio was calculated from ANOVA model.||
1619789|NCT02341599|2975437|Other|LS mean ratio of Group E: Period 1/Group E: Period 2|LS mean ratio|0.299|||||2-Sided|90.0|0.236|0.378|||||LS mean ratio was calculated from ANOVA model.||
1619790|NCT02341599|2975437|Other|LS mean ratio of Group E: Period 2/Group A|LS mean ratio|3.27|||||2-Sided|90.0|2.67|4.02|||||LS mean ratio was calculated from ANOVA model.||
1619791|NCT02341599|2975437|Other|LS mean ratio of Group E: Period 1/Group A|LS mean ratio|0.989|||||2-Sided|90.0|0.806|1.21|||||LS mean ratio was calculated from ANOVA model.||
1619792|NCT02341599|2975437|Other|LS mean ratio of Group D/Group A|LS mean ratio|2.51|||||2-Sided|90.0|2.06|3.06|||||LS mean ratio was calculated from ANOVA model.||
1619793|NCT02341599|2975437|Other|LS mean ratio of Group C/Group A|LS mean ratio|1.08|||||2-Sided|90.0|0.889|1.32|||||LS mean ratio was calculated from ANOVA model.||
1619794|NCT02341599|2975437|Other|LS mean ratio of Group B/Group A|LS mean ratio|1.29|||||2-Sided|90.0|1.06|1.58|||||LS mean ratio was calculated from analysis of variance (ANOVA) model.||
1619795|NCT02341144|2975510|Superiority|||||||0.44|||||||Wilcoxon (Mann-Whitney)||||
1619796|NCT02341144|2975511|Superiority|||||||0.11|||||||Wilcoxon (Mann-Whitney)||||
1619797|NCT02341144|2975512|Superiority|||||||0.39|||||||Chi-squared||||
1619798|NCT02341144|2975513|Superiority|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1619799|NCT02341144|2975514|Superiority|||||||0.11|||||||Wilcoxon (Mann-Whitney)||||
1619800|NCT02340975|2975540|Other|Comparison|Median Difference (Net)|2.8||||1|2-Sided|95.0|-16.8|22.4|||Fisher Exact||||
1619801|NCT02340975|2975540|Other|Comparison|Mean Difference (Net)|11.1||||0.2376|2-Sided|95.0|-0.7|23.0|||Fisher Exact||||
1619802|NCT02340806|2975579|Superiority|||||||0.37|||||||Kruskal-Wallis||||
1619803|NCT02340806|2975580|Superiority|||||||0.99|||||||Chi-squared||||
1619804|NCT02340806|2975581|Superiority|||||||0.67|||||||Chi-squared||||
1619805|NCT02340806|2975582|Superiority|||||||0.58|||||||Kruskal-Wallis||||
1619806|NCT02340806|2975583|Superiority|||||||0.92|||||||Wilcoxon (Mann-Whitney)||||
1619807|NCT02340806|2975585|Superiority|||||||0.66|||||||Kruskal-Wallis||||
1619808|NCT02340806|2975586|Superiority|||||||0.14|||||||Wilcoxon (Mann-Whitney)||||
1619809|NCT02340806|2975587|Superiority|||||||0.21|||||||Wilcoxon (Mann-Whitney)||||
1619810|NCT02340806|2975588|Superiority|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1619811|NCT02340806|2975589|Superiority|||||||0.67|||||||Chi-squared, Corrected||||
1619812|NCT02340663|2975604|Other|||||||0.923||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)||||
1619813|NCT02340663|2975605|Other|||||||0.643||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)||||
1619814|NCT02340663|2975606|Other|||||||0.505||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)||||
1619815|NCT02340663|2975607|Other|||||||0.287||||||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|Wilcoxon (Mann-Whitney)||||
1619816|NCT02340663|2975608|Other|||||||0.289|||||||Wilcoxon (Mann-Whitney)|||The P-value refers to the main effect of treatment group, i.e., differences between SOVA bite splints and Michigan bite splints.|
1619817|NCT02340663|2975609|Other|||||||0.292||||||"The P-value refers to the difference in group means, see Group Means row in the table."|Mixed Models Analysis||||
1619818|NCT02340663|2975610|Other|||||||0.53||||||"The P-value refers to the difference in group means, see Group Means row in the table."|ANOVA||||
1619819|NCT02340663|2975611|Other|||||||0.952||||||"The P-value refers to the difference in group means, see Group Means row in the table."|ANOVA||||
1619820|NCT02340663|2975612|Other|||||||0.238|||||||Wilcoxon (Mann-Whitney)||||
1619821|NCT02340663|2975613|Other|||||||0.731|||||||Wilcoxon (Mann-Whitney)||||
1619822|NCT02340663|2975614|Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1619823|NCT02340663|2975615|Other|||||||0.081|||||||Wilcoxon (Mann-Whitney)||||
1619824|NCT02340663|2975616|Other|||||||0.22|||||||Wilcoxon (Mann-Whitney)||||
1619825|NCT02340663|2975617|Other|||||||0.544|||||||Wilcoxon (Mann-Whitney)||||
1619826|NCT02340663|2975618|Other||||||<|0.01||||||The P-value given is the computed value|Mixed Models Analysis||||
1619827|NCT02340663|2975619|Other|||||||0.75|||||||Wilcoxon (Mann-Whitney)||||
1619828|NCT02340663|2975622|Other|||||||0.049|||||||Wilcoxon (Mann-Whitney)||||
1619829|NCT02340663|2975623|Other|||||||0.255|||||||Wilcoxon (Mann-Whitney)||||
1619830|NCT02340663|2975624|Other|||||||0.695|||||||t-test, 2 sided||||
1619831|NCT02340663|2975625|Other|||||||0.626|||||||Wilcoxon (Mann-Whitney)||||
1619832|NCT02340663|2975626|Other|||||||0.249|||||||Wilcoxon (Mann-Whitney)||||
1619833|NCT02340663|2975627|Other|||||||0.665|||||||t-test, 2 sided||||
1619834|NCT02340663|2975628|Other|||||||0.045|||||||ANOVA||||
1619835|NCT02340663|2975629|Other|||||||0.23|||||||t-test, 2 sided||||
1619836|NCT02340520|2975630|Other||||||>|0.1|||||||ANOVA||||
1619837|NCT02340520|2975631|Other||||||>|0.05|||||||t-test, 2 sided||||
1619838|NCT02340221|2975639|Superiority||Hazard Ratio (HR)|0.66||||0.0023|2-Sided|95.0|0.51|0.86|||Log Rank||||
1619839|NCT02340221|2975640|Superiority||Hazard Ratio (HR)|0.77|||||2-Sided|95.0|0.23|2.59|||||||
1619840|NCT02340221|2975642|Superiority||Hazard Ratio (HR)|0.85|||||2-Sided|95.0|0.58|1.25|||||||
1619843|NCT02340104|2975645|Equivalence|Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as model with treatment as a fixed effect and participant and error as random effects.|Ratio of Geometric LS Means|0.789|||||2-Sided|90.0|0.769|0.81|||||Geometric Least Square (LS) Means values were calculated using Log pharmacokinetic (PK) model with treatment, participant, random error as independent variables, where participant was fitted as a random effect.||
1619844|NCT02340091|2975646|Superiority||Subjects % with difference in VAS ≥ 10mm|0.9194|||||2-Sided|95.0|0.8|0.97|||||||
1619845|NCT02340078|2975647|Superiority||Subjects % with difference in VAS ≥ 10mm|0.9516|||||2-Sided|95.0|0.87|0.99|||||||
1619846|NCT02339415|2975683|Superiority||Mean Difference (Net)|-0.54|Standard Error of the Mean|0.17||0.002|2-Sided|95.0|-0.88|-0.2|||Mixed Models Analysis|included predictors: treatment, assigned treatment sequence and pre-treatment biomarker level.|because biomarkers were analyzed on natural log scale, the estimated parameter is the log-transformed mean percent difference in treatment effect on Edoxaban vs. Placebo.||
1619847|NCT02339415|2975684|Superiority||Mean Difference (Net)|0.08|Standard Error of the Mean|0.07||0.26|2-Sided|95.0|-0.06|0.21|||Mixed Models Analysis|included predictors: treatment, assigned treatment sequence and pre-treatment biomarker level.|because biomarkers were analyzed on natural log scale, the estimated parameter is the log-transformed mean percent difference in treatment effect on Edoxaban vs. Placebo.||
1619848|NCT02339285|2975691|Other||||||>|0.1|||||||ANOVA|||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG 4 weeks after completion of the intervention between treatment groups."|
1619849|NCT02339285|2975692|Other|F-test; Interaction effect (region x condition)|||||>|0.1|||||||ANOVA|F(6, 68.284)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."|
1619850|NCT02339285|2975692|Other|F-test; Region effect (region defined as region of brain - frontal, parietal, occipital temporal)|||||<|0.001|||||||ANOVA|F(3, 79.358)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."|
1619851|NCT02339285|2975692|Other|F-test; Condition effect|||||<|0.05|||||||ANOVA|F(2,21.595)||"Null hypothesis: There is no difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups.~Alternative hypothesis: There is a difference in changes of alpha frequency power between baseline EEG and EEG on Day 5 of Stimulation between treatment groups."|
1619852|NCT02339285|2975693|Other|F-test; Interaction effect (session x treatment)|||||>|0.1|||||||ANOVA|F(2,29)|||
1619853|NCT02339285|2975693|Other|F-test; Session effect|||||<|0.001|||||||ANOVA|F(1, 31)||"Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups."|
1619854|NCT02339285|2975693|Other|F-test; Treatment effect|||||>|0.1|||||||ANOVA|F(2, 29)||"Null hypothesis: There is no difference baseline and the 4 week follow up in MADRS score between treatment groups.~Alternative hypothesis: There is a difference between baseline and the 4 week follow up MADRS score between treatment groups."|
1619855|NCT02339155|2975706|Other||Ratio|0.98|||<|0.0001|2-Sided|90.0|0.89|1.07|||t-test, 1 sided||Week 26||
1619856|NCT02339155|2975706|Other||Ratio|1.09|||<||2-Sided|90.0|0.98|1.22|||||Week 8||
1619857|NCT02339155|2975707|Non-Inferiority|If the upper bound of the 90% confidence interval (CI) or the ratio of anti-PA Ab (attributable to AVA) GMCs between the AVA and the AVA + raxibacumab groups at Week 4 is less than 1.5, non-inferiority was to be established.|Ratio|1.18||||0.0016|2-Sided|90.0|1.03|1.35|||t-test, 1 sided||||
1619858|NCT02338843|2975756|Superiority||Odds Ratio (OR)|7.95|||<|0.001|2-Sided|95.0|4.76|13.3|||Regression, Logistic|Stratified logistic regression model. Adjusted by baseline MAP and APACHE II, vasopressin use and average NED 6 hours prior to randomization.|||
1619859|NCT02338492|2975774|Other||Percentage of Subjects|82.7|||||2-Sided|95.0|73.0|90.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Safety Success|
1619860|NCT02338492|2975774|Other||Percentage of Subjects|82.7|||||2-Sided|95.0|73.0|90.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation|
1619861|NCT02338492|2975774|Other||Percentage of Subjects|91.4|||||2-Sided|95.0|83.0|96.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: No additional surgical interventions of revisions, supplements, fixations or removals|
1619862|NCT02338492|2975774|Other||Percentage of Subjects|91.4|||||2-Sided|95.0|83.0|96.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no serious device related complications|
1619863|NCT02338492|2975774|Other||Percentage of Subjects|86.4|||||2-Sided|95.0|77.0|93.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Safety Success|
1619864|NCT02338492|2975774|Other||Percentage of Subjects|86.4|||||2-Sided|95.0|77.0|93.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation|
1619865|NCT02338492|2975774|Other||Percentage of Subjects|95.1|||||2-Sided|95.0|88.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: No additional surgical interventions of revisions, supplements, fixations or removals|
1619866|NCT02338492|2975774|Other||Percentage of Subjects|93.8|||||2-Sided|95.0|86.0|98.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no serious device related complications|
1619867|NCT02338492|2975774|Other||Percentage of Subjects|92.6|||||2-Sided|95.0|85.0|97.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Safety Success|
1619868|NCT02338492|2975774|Other||Percentage of Subjects|93.8|||||2-Sided|95.0|86.0|98.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation|
1619869|NCT02338492|2975774|Other||Percentage of Subjects|98.8|||||2-Sided|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: No additional surgical interventions of revisions, supplements, fixations or removals|
1619870|NCT02338492|2975774|Other||Percentage of Subjects|96.3|||||2-Sided|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no serious device related complications|
1619871|NCT02338492|2975774|Other||Percentage of Subjects|96.3|||||2-Sided|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Safety Success|
1619872|NCT02338492|2975774|Other||Percentage of Subjects|96.3|||||2-Sided|95.0|90.0|99.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation|
1619873|NCT02338492|2975774|Other||Percentage of Subjects|98.8|||||2-Sided|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: No additional surgical interventions of revisions, supplements, fixations or removals|
1619874|NCT02338492|2975774|Other||Percentage of Subjects|98.8|||||2-Sided|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications|
1619875|NCT02338492|2975774|Other||Percentage of Subjects|98.8|||||2-Sided|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Safety Success|
1619876|NCT02338492|2975774|Other||Percentage of Subjects|98.8|||||2-Sided|95.0|93.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation|
1619877|NCT02338492|2975774|Other||Percentage of Subjects|100.0|||||2-Sided|95.0|96.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: No additional surgical interventions of revisions, supplements, fixations or removals|
1619878|NCT02338492|2975774|Other||Percentage of Subjects|100.0|||||2-Sided|95.0|96.0|100.0||||||95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications|
1619879|NCT02338492|2975776|Superiority|||||||0.615||||||P-value not adjusted for multiple comparisons as the second co-primary endpoint will only be tested if the p-value for VAS improvement is <0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM) model employed, including the baseline VAS score. Missing values will be imputed.||Null hypothesis: Mean improvement in VAS over 90 days <= 53.8 (i.e. 80% of reference based on historical control data). The study was powered to 80% with 68 evaluable subjects, a standard deviation of 13.3 at each visit, a true mean improvement from baseline VAS across post-baseline visits of 57 and a within-patient correlation of VAS of 0.4. The historical control data comes from 4 selected articles (Gregory et al. 2011, Kim et al. 2011, Deschamps et al. 2012, and Pretell et al. 2010).|
1619880|NCT02338336|2975783|Superiority or Other||||||<|0.001|||||||ANOVA||||
1619881|NCT02338193|2975784|Superiority||||||<|0.03|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1619882|NCT02338193|2975785|Superiority||||||<|0.028|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1619883|NCT02338193|2975786|Superiority||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1619884|NCT02338193|2975787|Superiority||||||<|0.012|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1619885|NCT02338193|2975788|Superiority||||||<|0.02|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1619886|NCT02338193|2975789|Superiority||||||<|0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1619887|NCT02338193|2975790|Superiority||||||<|0.001|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1619888|NCT02338193|2975791|Superiority||||||<|0.001|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast|
1619889|NCT02338193|2975792|Superiority||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast|
1619890|NCT02338193|2975793|Superiority||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast|
1619891|NCT02338193|2975794|Superiority|||||||0.023|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast|
1619892|NCT02338193|2975795|Superiority|||||||0.007|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1619893|NCT02338193|2975796|Superiority||||||<|0.012|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1619894|NCT02338193|2975797|Superiority||||||<|0.01|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1619895|NCT02338193|2975798|Superiority||||||<|0.05|||||||ANOVA|One Way ANOVA with Bonferoni contrast test|||
1619897|NCT02337959|2975827|Superiority or Other|||||||0||||||level of significance (alpha) = 0.05|t-test, 1 sided|||Both the predicate and investigational images were randomized for the monitors. Predicate images could display on the left or the right and vice versa with the investigational. There were formulas in the spreadsheet that gave the preferences a numerical value, and subsequently became part of the analysis.|
1619898|NCT02337959|2975828|Superiority or Other|||||||0.028||||||Level of significance (alpha) = 0.05|t-test, 2 sided||||
1619899|NCT02337946|2975833|Superiority||Multivariable Hazard Ratio (HR)|0.9||||0.5901|2-Sided|95.0|0.6|1.33|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.|||
1619900|NCT02337946|2975835|Superiority||Adjusted Hazard Ratio (HR)|1.41||||0.3485|2-Sided|95.0|0.69|2.88|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.|||
1619901|NCT02337946|2975836|Superiority||Adjusted Hazard Ratio (HR)|0.93||||0.7349|2-Sided|95.0|0.6|1.43|||Regression, Multivariable Cox|The Cox regression model was adjusted by stratification factors except for study sites.|||
1619902|NCT02337946|2975837|Superiority||Difference of PFS rate between groups|0.9|||||2-Sided|95.0|-17.2|19.0|||||||Agresti-Caffo method was used for estimation of 95% CI.
1619903|NCT02337907|2975838|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|2.47|Standard Error of the Mean|0.936||0.0088|2-Sided|95.0|0.63|4.31||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1619904|NCT02337907|2975838|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.28|Standard Error of the Mean|0.94||0.1732|2-Sided|95.0|-0.57|3.13||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1619905|NCT02337907|2975838|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.12|Standard Error of the Mean|0.962||0.2455|2-Sided|95.0|-0.77|3.01||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1619906|NCT02337907|2975838|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.32|Standard Error of the Mean|0.933||0.1595|2-Sided|95.0|-0.52|3.15||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1619907|NCT02337907|2975839|Superiority||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.28||0.6889|2-Sided|95.0|-0.43|0.65||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|
1619908|NCT02337907|2975839|Superiority||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.27||0.7822|2-Sided|95.0|-0.45|0.6||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|
1619909|NCT02337907|2975839|Superiority||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.28||0.3643|2-Sided|95.0|-0.29|0.8||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|
1619910|NCT02337907|2975839|Superiority||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.28||0.7551|2-Sided|95.0|-0.46|0.64||p-value was nominal and not adjusted.|Mixed-effects Model for Repeated Measure|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|
1619911|NCT02337907|2975840|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.49|Standard Error of the Mean|1.066||0.6472|2-Sided|95.0|-2.59|1.61||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1619981|NCT02334306|2976137|Superiority||Difference in percentages|25.0||||0.252|2-Sided|90.0|-3.1|50.9|||Fisher Exact|||ESSDAI [3]|
1619912|NCT02337907|2975840|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.93|Standard Error of the Mean|1.064||0.3822|2-Sided|95.0|-1.16|3.03||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1619913|NCT02337907|2975840|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.41|Standard Error of the Mean|1.099||0.7105|2-Sided|95.0|-2.57|1.76||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1619914|NCT02337907|2975840|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.67|Standard Error of the Mean|1.066||0.5287|2-Sided|95.0|-1.43|2.77||p-value was nominal and not adjusted.|ANCOVA||The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1619915|NCT02337907|2975841|Superiority|H1-0: Mean NTB response of pooled doses of 10 mg QD, 25 mg QD, 25 mg BID and 50 mg QD = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.041||0.6492|2-Sided|95.0|-0.098|0.061||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.|
1619916|NCT02337907|2975841|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.057||0.1288|2-Sided|95.0|-0.199|0.025||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.|
1619917|NCT02337907|2975841|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Net)|0.0|Standard Error of the Mean|0.056||0.9321|2-Sided|95.0|-0.105|0.115||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.|
1619918|NCT02337907|2975841|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.057||0.9512|2-Sided|95.0|-0.116|0.109||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.|
1619919|NCT02337907|2975841|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.056||0.8694|2-Sided|95.0|-0.101|0.12||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.|
1619920|NCT02337907|2975842|Superiority|H1-0: Mean NTB response of pooled doses of 10 mg QD, 25 mg QD, 25 mg BID and 50 mg QD = Mean NTB response of placebo|Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.053||0.5687|2-Sided|95.0|-0.135|0.074||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|
1619940|NCT02337062|2975902|Superiority||||||<|0.001||||||The threshold for determining statistical significance in the comparison of incidence of success between the active and placebo groups (the primary efficacy analysis) was a p-value of 2.5% one-sided.|Chi-squared|||The primary efficacy analysis was a comparison of the incidence of the primary efficacy variable between the two groups that received APD421 and the group that received placebo, using Pearson’s χ2 test.|
1619941|NCT02336958|2975903|Superiority or Other|||||||0.459|||||||t-test, 2 sided||||
1619921|NCT02337907|2975842|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.074||0.0609|2-Sided|95.0|-0.285|0.006||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|
1619922|NCT02337907|2975842|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Net)|0.01|Standard Error of the Mean|0.071||0.8789|2-Sided|95.0|-0.13|0.152||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|
1619923|NCT02337907|2975842|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.075||0.7622|2-Sided|95.0|-0.125|0.171||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|
1619924|NCT02337907|2975842|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.073||0.7907|2-Sided|95.0|-0.163|0.124||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|
1619925|NCT02337738|2975867|Superiority or Other||LS Mean Difference|-0.6||||0.014|2-Sided|95.0|-1.07|-0.122|||ANCOVA||Estimated Value was reported for the difference between TVP-1012 0.5mg and Placebo (TVP-1012 0.5mg - Placebo).||
1619926|NCT02337738|2975867|Superiority or Other||LS Mean Difference|-0.84||||0.0006|2-Sided|95.0|-1.32|-0.364|||ANCOVA||Estimated Value was reported for the difference between TVP-1012 1mg and Placebo (TVP-1012 1mg - Placebo).||
1619927|NCT02337725|2975876|Superiority or Other||LS Mean Difference|-6.39|||<|0.0001|2-Sided|95.0|-8.53|-4.25|||ANCOVA||Estimated Value was reported for the least squares mean difference between TVP-1012 1mg and Placebo (TVP-1012 1mg - Placebo).||
1619928|NCT02337361|2975891|Other||||||||||||||||||Generalized estimating equations (GEE) tested DrinkWise’s effects on changes in depression over time controlling for demographic differences between study condition and study sites.
1619929|NCT02337361|2975892|Other||Odds Ratio (OR)|0.26|Standard Error of the Mean|0.15|<|0.01|2-Sided||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report significant depression at 6 month follow-up||
1619930|NCT02337361|2975893|Other||Odds Ratio (OR)|0.51|Standard Error of the Mean|0.2|<|0.1|2-Sided||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report any tobacco use at 6 month follow-up||Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.
1619931|NCT02337361|2975894|Other||Odds Ratio (OR)|0.23|Standard Error of the Mean|0.14|<|0.05|2-Sided||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report drinking a maximum quantity of 5 or more drinks in a day at 6 month follow-up||
1619932|NCT02337361|2975895|Other||Odds Ratio (OR)|0.22|Standard Error of the Mean|0.12|<|0.01|2-Sided||||||t-test, 2 sided||the e-SBI group was at reduced odds relative to the control group to report weekly or more frequent drinking at 6 month follow-up||Generalized estimating equations (GEE) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.
1619933|NCT02337361|2975896|Other||||||||||||||||||Generalized estimating equations tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation
1619934|NCT02337361|2975896|Other||||||||||||||||||Generalized estimating equations (GEE)(Diggle et al. 2002) tested e-SBI efficacy, controlling for demographic differences between study condition and study sites. GEE models estimate population average or marginal models and account for within-subject nonindependence (clustering) of observations across multiple waves of data collection and use all available data in model estimation.
1619935|NCT02337062|2975897|Superiority||||||<|0.001|||||||Log Rank||||
1619936|NCT02337062|2975898|Superiority||||||<|0.001|||||||Chi-squared||||
1619937|NCT02337062|2975899|Superiority|||||||0.002|||||||Chi-squared||||
1619938|NCT02337062|2975900|Superiority|||||||0.002|||||||Chi-squared||||
1619939|NCT02337062|2975901|Superiority|||||||0.003|||||||Chi-squared||||
1619942|NCT02336958|2975904|Superiority or Other|||||||1|||||||Fisher Exact||||
1620154|NCT02323646|2976834|Superiority|||||||0.8206|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620155|NCT02323646|2976834|Superiority|||||||0.7903|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1619943|NCT02336594|2975926|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|83.4|||||2-Sided|90.0|73.5|94.7|||||||
1619944|NCT02336594|2975927|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|85.5|||||2-Sided|90.0|73.9|98.8|||||||
1619945|NCT02336594|2975928|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|79.1|||||2-Sided|90.0|66.4|94.2|||||||
1619946|NCT02336594|2975929|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|134.0|||||2-Sided|90.0|114.0|156.0|||||||
1619947|NCT02336594|2975930|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|140.0|||||2-Sided|90.0|121.0|163.0|||||||
1619948|NCT02336594|2975931|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|182.0|||||2-Sided|90.0|144.0|230.0|||||||
1619949|NCT02336594|2975933|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|100.0|||||2-Sided|90.0|87.3|115.0|||||||
1619950|NCT02336594|2975934|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.|Geometric Least Squares mean Ratio (%)|97.3|||||2-Sided|90.0|85.6|111.0|||||||
1619951|NCT02336594|2975936|Non-Inferiority or Equivalence|The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the Pharmacokinetics (PK), Pharmacodynamics (PD), and safety profile of RDEA3170.|Geometric Least Squares Mean Ratio (%)|107.0|||||2-Sided|90.0|95.2|120.0|||||||
1619952|NCT02336555|2975937|Superiority||Odds Ratio (OR)|1.073|||||2-Sided|95.0|0.446|2.58|||||Logistic regression model with factors for treatment & baseline pain intensity||
1619953|NCT02336555|2975938|Superiority||Mean Difference (Final Values)|-0.452||||0.075|2-Sided|95.0|-1.076|0.172||Linear mixed model with a posterior probability evaluation for the treatment effect|Linear mixed model|One-sided p-value and a posterior probability greater than 90% that the treatment effect is less than 0.|||
1619954|NCT02336438|2975967|Superiority or Other|||||||0.13|||||||Wilcoxon Signed Rank Test||||
1619955|NCT02336438|2975968|Superiority or Other|||||||0.02|||||||Wilcoxon Signed Rank Test||||
1619956|NCT02336438|2975969|Superiority or Other|||||||0.0156|||||||Wilcoxon Signed Rank Test||||
1619957|NCT02336438|2975970|Superiority or Other|||||||0.77|||||||Wilcoxon Signed Rank Test||||
1619958|NCT02336438|2975971|Superiority or Other|||||||0.4922|||||||Wilcoxon Signed Rank Test||||
1619959|NCT02336438|2975972|Superiority or Other|||||||0.99|||||||Wilcoxon Signed Rank Test||||
1619960|NCT02336074|2976022|Superiority||Odds Ratio (OR)|0.41||||0.145|2-Sided||||||Regression, Logistic|||"Comparison of the proportion of patients with undetectable viral outgrowth using logistic regression.~The analysis was adjusted for stratum and baseline viral outgrowth. Missing baseline values were imputed."|
1619961|NCT02336074|2976024|Superiority|||||||0.26||||||Treatment arms were compared in terms of absolute total HIV DNA levels (on a log10-scale) at post-randomization weeks 16 and 18 adjusted for the baseline (i.e. randomization) level and by stratum.|Regression, Linear||||
1619962|NCT02334800|2976106|Superiority or Other||ratio of adjusted geometric mean|172.27|||||2-Sided|90.0|125.25|236.96|||||||
1619963|NCT02334800|2976106|Superiority or Other||ratio of adjusted geometric mean|137.5|||||2-Sided|90.0|99.96|189.12|||||||
1619964|NCT02334800|2976106|Superiority or Other||ratio of adjusted geometric mean|107.37|||||2-Sided|90.0|78.06|147.68|||||||
1619965|NCT02334800|2976109|Superiority or Other||ratio of adjusted geometric mean|178.39|||||2-Sided|90.0|138.62|229.57|||||||
1619966|NCT02334800|2976109|Superiority or Other||ratio of adjusted geometric mean|134.9|||||2-Sided|90.0|104.82|173.6|||||||
1619967|NCT02334800|2976109|Superiority or Other||ratio of adjusted geometric mean|82.14|||||2-Sided|90.0|63.83|105.71|||||||
1619968|NCT02334800|2976110|Superiority or Other||ratio of adjusted geometric mean|134.66|||||2-Sided|90.0|104.38|173.73|||||||
1619969|NCT02334800|2976110|Superiority or Other||ratio of adjusted geometric mean|115.57|||||2-Sided|90.0|89.58|149.11|||||||
1619970|NCT02334800|2976110|Superiority or Other||ratio of adjusted geometric mean|72.81|||||2-Sided|90.0|56.43|93.93|||||||
1619971|NCT02334800|2976111|Superiority or Other||ratio of adjusted geometric mean|176.88|||||2-Sided|90.0|139.28|224.63|||||||
1619972|NCT02334800|2976111|Superiority or Other||ratio of adjusted geometric mean|134.28|||||2-Sided|90.0|105.73|170.53|||||||
1619973|NCT02334800|2976111|Superiority or Other||ratio of adjusted geometric mean|83.01|||||2-Sided|90.0|65.37|105.43|||||||
1619974|NCT02334800|2976112|Superiority or Other||ratio of adjusted geometric mean|129.89|||||2-Sided|90.0|95.63|176.43|||||||
1619975|NCT02334800|2976112|Superiority or Other||ratio of adjusted geometric mean|117.75|||||2-Sided|90.0|86.69|159.95|||||||
1619976|NCT02334800|2976112|Superiority or Other||ratio of adjusted geometric mean|94.99|||||2-Sided|90.0|69.93|129.03|||||||
1619977|NCT02334800|2976113|Superiority or Other||ratio of adjusted geometric mean|133.68|||||2-Sided|90.0|105.0|170.19|||||||
1619978|NCT02334800|2976113|Superiority or Other||ratio of adjusted geometric mean|115.3|||||2-Sided|90.0|90.57|146.79|||||||
1619979|NCT02334800|2976113|Superiority or Other||ratio of adjusted geometric mean|73.6|||||2-Sided|90.0|57.81|93.71|||||||
1619980|NCT02334306|2976137|Superiority||Difference in precentages|25.0||||0.252|2-Sided|90.0|-3.1|50.9|||Fisher Exact|||ESSDAI[4]|
1619982|NCT02334306|2976138|Superiority||Mean Difference (Net)|0.4|Standard Error of the Mean|0.7||0.574|2-Sided|90.0|-0.8|1.6|||ANCOVA||Adjusted mean difference for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval and p-value.||
1619983|NCT02334306|2976140|Superiority||Median Difference (Net)|1.01|Standard Error of the Mean|0.26||0.972|2-Sided|90.0|0.64|1.59|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For PD-1/ICOS TFH cells|
1619984|NCT02334306|2976140|Superiority||Median Difference (Net)|0.43|Standard Error of the Mean|0.28||0.008|2-Sided|90.0|0.26|0.7|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For CD4/ICOS TFH cells|
1619985|NCT02334306|2976140|Superiority||Mean Difference (Net)|0.87|Standard Error of the Mean|0.17||0.44|2-Sided|90.0|0.65|1.18|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For total plasma cells|
1619986|NCT02334306|2976141|Superiority||Median Difference (Net)|0.65|Standard Error of the Mean|0.4||0.291|2-Sided|90.0|0.33|1.28|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For TFH cells|
1619987|NCT02334306|2976141|Superiority||Mean Difference (Net)|0.93|Standard Error of the Mean|0.33||0.82|2-Sided|90.0|0.52|1.64|||ANCOVA||Adjusted Geometric mean ratio for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval, SE (log), and p-value.|For plasma cell levels|
1619988|NCT02334306|2976142|Superiority||Mean Difference (Net)|-1.4|Standard Error of the Mean|1.3||0.262|2-Sided|90.0|-3.6|0.7|||ANCOVA||Adjusted mean difference for MEDI5872 210 mg:Placebo was calculated with associated 90% confidence interval and p-value.||
1619989|NCT02334267|2976143|Superiority or Other||||||<|0.0001||||||trend analysis over time|Mixed Models Analysis||||
1619990|NCT02334267|2976144|Superiority or Other|||||||0.003||||||trend analysis over time|Mixed Models Analysis||||
1619991|NCT02334267|2976145|Superiority or Other|||||||0.4||||||trend analysis over time|Mixed Models Analysis||||
1619992|NCT02334267|2976146|Superiority or Other||||||<|0.0001||||||trend analysis over time|Mixed Models Analysis||||
1619993|NCT02333331|2976167|Superiority||Mean Difference (Net)|1.06|||<|0.001|2-Sided|95.0|1.04|1.07|||Mixed Models Analysis||||
1619994|NCT02333331|2976167|Superiority||Mean Difference (Net)|1.05|||<|0.001|2-Sided|95.0|1.03|1.08|||Mixed Models Analysis||||
1619995|NCT02333331|2976167|Superiority||Mean Difference (Net)|1.0|||<|0.458|2-Sided|95.0|0.98|1.02|||Mixed Models Analysis||||
1619996|NCT02333331|2976168|Superiority||Mean Difference (Net)|1.06|||<|0.001|2-Sided|95.0|1.05|1.08|||Mixed Models Analysis||||
1619997|NCT02333331|2976168|Superiority||Mean Difference (Net)|1.06|||<|0.001|2-Sided|95.0|1.03|1.09|||Mixed Models Analysis||||
1619998|NCT02333331|2976168|Superiority||Mean Difference (Net)|1.01|||<|0.213|2-Sided|95.0|0.99|1.03|||Mixed Models Analysis||||
1619999|NCT02333331|2976169|Superiority||Mean Difference (Net)|0.03||||0.161|2-Sided|95.0|-0.03|0.09|||Mixed Models Analysis||||
1620000|NCT02333331|2976169|Superiority||Mean Difference (Net)|0.1||||0.055|2-Sided|95.0|-0.02|0.22|||Mixed Models Analysis||||
1620001|NCT02333331|2976169|Superiority||Mean Difference (Net)|0.0||||0.488|2-Sided|95.0|-0.1|0.1|||Mixed Models Analysis||||
1620002|NCT02333331|2976170|Superiority||Mean Difference (Final Values)|10.31||||0.163|2-Sided|95.0|-10.4|30.98|||Mixed Models Analysis||||
1620003|NCT02333331|2976170|Superiority||Mean Difference (Final Values)|19.6||||0.178|2-Sided|95.0|-22.2|61.41|||Mixed Models Analysis||||
1620004|NCT02333331|2976170|Superiority||Mean Difference (Final Values)|-3.32||||0.576|2-Sided|95.0|-37.6|30.95|||Mixed Models Analysis||||
1620005|NCT02333331|2976171|Superiority||Mean Difference (Final Values)|0.31||||0.134|2-Sided|95.0|-0.24|0.87|||Mixed Models Analysis||||
1620006|NCT02333331|2976171|Superiority||Mean Difference (Final Values)|0.26||||0.32|2-Sided|95.0|-0.83|1.35|||Mixed Models Analysis||||
1620007|NCT02333331|2976171|Superiority||Mean Difference (Final Values)|0.28||||0.274|2-Sided|95.0|-0.64|1.21|||Mixed Models Analysis||||
1620008|NCT02332876|2976179|Superiority||||||<|0.05|||||||Mixed Models Analysis||||
1620009|NCT02332824|2976184|Superiority or Other||LS Mean difference|-0.53|||<|0.0001|2-Sided|95.0|-0.6874|-0.3719||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (Candesartan cilexetil 8 mg −placebo group) in log-transformed UACR changes from baseline to the end of treatment period.||
1620010|NCT02332824|2976184|Superiority or Other||LS Mean difference|-0.65|||<|0.0001|2-Sided|95.0|-0.8083|-0.4908||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 80 mg −placebo) in log-transformed UACR changes from baseline to the end of treatment period.||
1620011|NCT02332824|2976184|Superiority or Other||LS Mean difference|-0.63|||<|0.0001|2-Sided|95.0|-0.7897|-0.4711||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 40 mg −placebo) in log-transformed UACR changes from baseline to the end of treatment period.||
1620012|NCT02332824|2976184|Superiority or Other||LS Mean difference|-0.469|||<|0.0001|2-Sided|95.0|-0.6251|-0.3132||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 20 mg−placebo) in log-transformed UACR changes from baseline to the end of treatment period.||
1620013|NCT02332824|2976184|Superiority or Other||LS Mean difference|-0.325|||<|0.0001|2-Sided|95.0|-0.4845|-0.1649||In the primary analysis, each TAK-272 group will be compared with placebo group based on a step-down testing procedure, which will be employed for multiple comparison adjustment.|ANCOVA||Estimated Value was for LS mean differences (TAK-272 5 mg−placebo) in log-transformed UACR changes from baseline to the end of treatment period.||
1620551|NCT02314546|2977583|Superiority or Other|||||||0.04|||||||Kruskal-Wallis||||
1620014|NCT02332590|2976239|Superiority||LS Mean Difference|1.768||||0.0689|2-Sided|95.0|-0.137|3.674||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline FACIT-F score as a continuous covariates.|
1620015|NCT02332590|2976240|Superiority||LS Mean Difference|2.65||||0.0006|2-Sided|95.0|1.147|4.153||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline SF-36 PCS score as a continuous covariates.|
1620016|NCT02332590|2976241|Superiority||LS Mean Difference|-0.182||||0.0037|2-Sided|95.0|-0.305|-0.059||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI score as a continuous covariates.|
1620017|NCT02332590|2976242|Superiority||Odds Ratio (OR)|1.8||||0.0074|2-Sided|95.0|1.168|2.773||Threshold for significance 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.|
1620018|NCT02332590|2976243|Superiority||Odds Ratio (OR)|2.286||||0.0036|2-Sided|95.0|1.3|4.02||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.|
1620019|NCT02332590|2976244|Superiority||Odds Ratio (OR)|1.976||||0.0017|2-Sided|95.0|1.289|3.028||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.|
1620020|NCT02332590|2976245|Superiority||Odds Ratio (OR)|4.879|||<|0.0001|2-Sided|95.0|2.536|9.389||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg vs. Adalimumab 40 mg|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified by region.|
1620021|NCT02332590|2976246|Superiority||LS Mean Difference|-1.077|||<|0.0001|2-Sided|95.0|-1.361|-0.793||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg vs. Adalimumab 40 mg|Analysis was performed using MMRM approach with treatment, region, visits, and treatment-by-visit interaction as fixed effects and baseline DAS28-ESR score as a continuous covariates. Hierarchical testing procedure was used to control overall alpha error rate at 0.05 level and handle multiple endpoint analyses. Testing was then performed sequentially in order endpoints are reported. Hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|
1620022|NCT02332239|2976247|Superiority|||||||0.33|||||||t-test, 2 sided||||
1620023|NCT02332239|2976250|Superiority||Median Difference (Final Values)|-7.29|Standard Error of the Mean|2.62||0.01|2-Sided||||||quantile regression models|Controlled for baseline and gender|d=0.46|CTS Score where baseline >=4: 8 week|
1620024|NCT02332239|2976251|Superiority||Mean Difference (Final Values)|-7.48|Standard Error of the Mean|4.11||0.07|2-Sided||||||Mixed effects longitudinal regression||d=0.37|BDI Score where baseline >=20: 8 week|
1620025|NCT02331940|2976257|Superiority or Other|||||||0.88||||||p<0.05 was considered statistically significant|t-test, 1 sided||||
1620026|NCT02330549|2976357|Other|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|3.2146|Standard Error of the Mean|2.757||0.2522|2-Sided|95.0|-2.4|8.83||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of ADIPO-IR as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 24|
1620027|NCT02330549|2976357|Other|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-1.505|Standard Error of the Mean|2.369||0.5297|2-Sided|95.0|-6.33|3.32||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of ADIPO-IR as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 12|
1620028|NCT02330549|2976358|Other|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-0.4113|Standard Error of the Mean|0.205||0.053|2-Sided|95.0|-0.83|0.01||An ANCOVA model that included treatment and presence or absence of NASH as factors, and the baseline value of Matsuda index as a covariate was used for analysis.|ANCOVA|||Change form Baseline to Week 24|
1620029|NCT02330549|2976358|Other|This was a proof of concept study, and is not powered for statistical detection of differences between groups, no adjustments for multiplicity was made, or no-imputation for missing data.|LS Mean Difference|-0.2286|Standard Error of the Mean|0.195||0.2483|2-Sided|95.0|-0.62|0.17||An analysis of covariance (ANCOVA) model that included treatment and presence or absence of nonalcoholic steatohepatitis (NASH) as factors, and the baseline value of Matsuda index as a covariate was used for analysis.|ANCOVA|||Change from Baseline to Week 12|
1620030|NCT02330276|2976362|Superiority or Other|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models||||
1620031|NCT02330276|2976363|Superiority or Other|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models||||
1620032|NCT02330276|2976364|Superiority or Other|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models||||
1620156|NCT02323646|2976834|Superiority|||||||0.1358|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620552|NCT02314546|2977584|Superiority or Other|||||||0.02|||||||Kruskal-Wallis||||
1620033|NCT02330276|2976365|Other|one way ANOVA between groups|Mean Difference (Final Values)|77.9|Standard Deviation|11.9|<|0.05|2-Sided|95.0|70.3|85.5||for change in heart rate at 24 hr post-dosing from baseline between the 3 doses|ANOVA|||Primary hypothesis: None of the doses of (+)-epicatechin will differ with regard to change from baseline in any of the major safety endpoints; heart rate, systolic and diastolic blood pressure.|
1620034|NCT02330276|2976366|Superiority or Other|||||||0.05||||||The reported P-Value was calculated|General linear mixed-effects models||||
1620035|NCT02330172|2976367|Superiority|||||||0.05|||||||t-test, 2 sided||||
1620036|NCT02330172|2976368|Superiority|||||||0.05|||||||t-test, 2 sided||||
1620037|NCT02330094|2976369|Superiority|||||||0.66|||||||ANOVA||||
1620038|NCT02330094|2976370|Superiority|||||||0.79|||||||ANOVA||||
1620039|NCT02330094|2976371|Superiority|||||||0.7|||||||t-test, 2 sided||||
1620040|NCT02330081|2976384|Non-Inferiority|One of the FDA validation level requirements for test platelet quality is that the lower 1-sided 95% confidence limit of the mean platelet survival time must be ≥58% of fresh control platelet mean survival time|Mean Ratio Survival Time|81.0|Standard Error of the Mean|2.0|||1-Sided|95.0|77.0||||||Estimate is the ratio of the mean platelet survival time of treatment over control||
1620041|NCT02330081|2976385|Non-Inferiority|The FDA validation level requirements for test platelet quality is that the lower 1-sided 95% confidence limit of platelet recovery must be ≥ 66% of fresh control platelet values|Risk Ratio (RR)|83.3|Standard Error of the Mean|4.97|||1-Sided|95.0|76.2||||||Estimate is the ratio of the mean platelet recovery of treatment over control||
1620042|NCT02329587|2976421|Other||Odds Ratio (OR)|1.125|||||2-Sided||||||||||
1620043|NCT02329587|2976422|Other||Between-groups effect size (Hedge's g)|0.704|||||2-Sided||||||||||
1620044|NCT02329587|2976423|Other||Between-group effect size (Hedge's g)|-0.151|||||2-Sided||||||||||
1620045|NCT02329587|2976424|Other||Between-groups effect size (Hedge's g)|-0.007|||||2-Sided||||||||||
1620046|NCT02329587|2976425|Other||Between-group effect size (Hedge's g)|-0.214|||||2-Sided||||||||||
1620047|NCT02329587|2976426|Other||Between-group effect size (Hedge's g)|0.138|||||2-Sided||||||||||
1620048|NCT02329223|2976441|Superiority or Other||Mean Difference (Net)|-2.29|Standard Error of the Mean|0.828||0.006|2-Sided|95.0|-3.921|-0.654|||Mixed Model with repeated measures(MMRM)||||
1620049|NCT02329223|2976441|Superiority or Other||Mean Difference (Net)|-3.7|Standard Error of the Mean|0.815|<|0.001|2-Sided|95.0|-5.31|-2.098|||Mixed Model with repeated measures(MMRM)||||
1620050|NCT02329015|2976446|Superiority or Other|||||||0.301|||||||Regression, Linear|||Analysis of the Voluntary subscale of the Response to Stress Questionnaire|
1620051|NCT02329015|2976447|Superiority or Other||Slope|2.7||||0.009|2-Sided|95.0|0.69|4.71|||Regression, Linear|||Model 3: Per Protocol Analysis: it was hypothesized that any benefit of yoga education would only accrue if the student was assigned to yoga classes and actively participated in the class. A third Model was fit with an interaction term for class assignment and class participation.|
1620052|NCT02329015|2976447|Superiority or Other||Slope|1.67||||0.08|2-Sided|95.0|-0.21|3.55|||Regression, Linear|||Model 2: As active participation between groups was significantly different a second intent to treat analysis was performed which added to Model 1 (controlling for previous year GPA) by controlling for active participation.|
1620053|NCT02329015|2976447|Superiority or Other||Slope|0.58||||0.54|2-Sided|95.0|-1.25|2.41|||Regression, Logistic|||Model 1: An intent to treat analyses was performed determining effect of group assignment on academic performance while controlling for previous year GPA.|
1620054|NCT02328807|2976452|Other||Negative biopsy rate at 6 months after R|0.667|||||2-Sided|95.0|0.223|0.957|||||Two-sided exact confidence interval was calculated using Clopper-Pearson method.|This trail is a single cohort study and no statistical hypothesis test for the primary outcome was planned.|
1620055|NCT02328404|2976470|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1620056|NCT02328404|2976471|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)||||
1620057|NCT02328404|2976472|Superiority or Other|||||||0.25|||||||t-test, 2 sided||||
1620058|NCT02328404|2976473|Superiority or Other|||||||0.65|||||||t-test, 2 sided||||
1620059|NCT02328404|2976474|Superiority or Other|||||||0.35|||||||t-test, 2 sided||||
1620060|NCT02328404|2976475|Superiority or Other|||||||0.01|||||||t-test, 2 sided||||
1620061|NCT02328404|2976476|Superiority or Other|||||||0.6|||||||t-test, 2 sided||||
1620062|NCT02328404|2976477|Superiority or Other|||||||0.89|||||||t-test, 2 sided||||
1620063|NCT02328404|2976478|Superiority or Other|||||||0.001|||||||Chi-squared||||
1620064|NCT02328404|2976479|Superiority or Other|||||||0.01|||||||t-test, 2 sided||||
1620065|NCT02328404|2976480|Superiority or Other|||||||0.08|||||||t-test, 2 sided||||
1620066|NCT02328404|2976481|Superiority or Other|||||||0.51|||||||t-test, 2 sided||||
1620067|NCT02328404|2976482|Superiority or Other|||||||0.67|||||||t-test, 2 sided||||
1620068|NCT02328404|2976483|Superiority or Other||||||<|0||||||A P-value < 0.05 would be considered statistically significant.|t-test, 2 sided|||Both arms where evaluated at which paired t-test for the mean difference in the two arm was calculated . where the serum 25-OH Vit D3 was measured at 0 day time and after the end of the study. after that a paired t-test where applied for the difference for the 25-OH VitD3 levels between the two time points|
1620069|NCT02328404|2976484|Superiority or Other|||||||0.001|||||||Chi-squared|Fisher Exact test was used||The participants in the treatment and placebo groups will be classified into two categories of prognosis (improved and not improved) and will be analyzed using Chi-square test, if Chi-square is higher than 3.84 (df=1) it will be statistically significant (p-value</= 0.05)|
1620070|NCT02328105|2976489|Other|Estimation only.|Disease Control Rate|0.818|||||2-Sided|95.0|0.482|0.977|||||Confidence interval estimated using the Clopper Pearson method.||
1620120|NCT02326220|2976650|Superiority||LS Mean Difference|-50.0|||<|0.0001|2-Sided|95.0|-57.3|-42.7||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1620157|NCT02323646|2976834|Superiority|||||||0.3896|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620071|NCT02328105|2976490|Superiority|Assuming the true overall response rate is 0.20 under the null hypothesis, then this design will provide 81% power to detect a difference of 0.15 under the alternative hypothesis, assuming a one-sided alpha = 0.09 significance level. A three stage design with n=15, 30 and 45 subjects was determined with the following rejection regions: For n = 15, the rejection region in number of responses (CR or PR) is 0 - 2, for n = 30 it is 3 - 6, and for n = 45 it is 7 - 12.|Response Rate|0.364||||0.161|2-Sided|95.0|0.109|0.692||This p-value is only based on partial enrollment of stage 1. As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.||
1620072|NCT02327325|2976517|Superiority||Mean Difference (Final Values)|0.11||||0.97|2-Sided|95.0|-7.07|1.07|||Mixed Models Analysis|||This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.|
1620073|NCT02327325|2976517|Superiority||Median Difference (Final Values)|0.16||||0.95|2-Sided|95.0|-4.86|5.19|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.|
1620074|NCT02327325|2976518|Superiority||Mean Difference (Final Values)|-1.99||||0.17|2-Sided|95.0|-4.85|0.86|||Mixed Models Analysis|||This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.|
1620075|NCT02327325|2976518|Superiority||Mean Difference (Final Values)|-4.1|||<|0.01|2-Sided|95.0|-6.85|-1.34|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.|
1620076|NCT02327325|2976519|Superiority||Mean Difference (Final Values)|2.91||||0.196|2-Sided|95.0|-1.55|7.39|||Mixed Models Analysis|||This is the comparison of the PA+CBT group with the wait list control. Rejection of the null hypothesis means that the PA+CBT group was superior to the wait list group.|
1620077|NCT02327325|2976519|Superiority||Mean Difference (Final Values)|3.64||||0.097|2-Sided|95.0|-0.69|7.96|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.|
1620078|NCT02327325|2976520|Superiority||Mean Difference (Final Values)|-4.1||||0.28|2-Sided|95.0|-11.69|3.48|||Mixed Models Analysis|||This is the comparison of the PA + CBT only group with the wait list control. Rejection of the null hypothesis means that the PA + CBT group was superior to the wait list group.|
1620079|NCT02327325|2976520|Superiority||Mean Difference (Net)|-6.11||||0.07|2-Sided|95.0|-12.85|0.64|||Mixed Models Analysis|||This is the comparison of the PA only group with the wait list control. Rejection of the null hypothesis means that the PA group was superior to the wait list group.|
1620080|NCT02327325|2976521|Superiority||Mean Difference (Final Values)|-3.26||||0.06|2-Sided|95.0|-6.69|0.06|||Mixed Models Analysis|||This is the comparison of the PA & CBT group to the wait list group. Rejection of the null hypothesis means that the PA + CBT group was superior on this outcome to the wait list group.|
1620081|NCT02327325|2976521|Superiority||Mean Difference (Final Values)|-2.94||||0.08|2-Sided|95.0|-6.24|0.35|||Mixed Models Analysis|||This is the comparison between physical activity only and the wait list group. Rejection of the null hypothesis means that the physical activity group had greater improvement than the wait list group.|
1620082|NCT02327143|2976554|Superiority or Other||Ratio of geometric least squares|0.448|||||2-Sided|90.0|0.395|0.508|||||Absolute bioavailability of LY2835219 following the administration of 200 mg LY2835219 (oral) with 0.4 mg [13C8]-LY2835219 (IV).||
1620083|NCT02327013|2976600|Superiority|The mean difference between treatment groups was estimated based on LS means for the treatment-by-visit interaction in stagewise MMRM analyses. In each stage, the REML-based MMRM model included site ID (stage 1 only), visit, treatment (placebo, vortioxetine 10mg, vortioxetine 20mg), baseline (for the stage) AISRS total score, treatment-by-visit interaction, and baseline (stage) AISRS total score-by-visit interaction, with an unstructured covariance structure to model the within-patient errors.|Mean Difference (Final Values)|1.0|Standard Deviation|1.9||0.601|2-Sided|95.0|-2.8|4.8|||weighed z-score|Equally weighed LS z-score, combining results from stagewise MMRM, was compared to standard normal distribution.|||
1620084|NCT02327013|2976600|Superiority||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|1.8||0.9723|2-Sided|95.0|-3.6|3.5|||weighed z-score|Equally weighed LS z-score, combining results from stagewise MMRM, was compared to standard normal distribution.||The mean difference between treatment groups was estimated based on LS means for the treatment-by-visit interaction in stagewise MMRM analyses. In each stage, the REML-based MMRM model included site ID (stage 1 only), visit, treatment (placebo, vortioxetine 10mg, vortioxetine 20mg), baseline (for the stage) AISRS total score, treatment-by-visit interaction, and baseline (stage) AISRS total score-by-visit interaction, with an unstructured covariance structure to model the within-patient errors.|
1620085|NCT02326649|2976607|Other||Mean Difference (Final Values)|0.557|Standard Error of the Mean|0.452||0.238|2-Sided|95.0|-0.411|1.526|||Regression, Linear|||Systolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure|
1620086|NCT02326649|2976607|Other||Mean Difference (Final Values)|-0.427|Standard Error of the Mean|0.305||0.183|2-Sided|95.0|-1.081|0.227|||Regression, Linear|||Diastolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure|
1620087|NCT02326649|2976607|Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.417||0.25|2-Sided|95.0|-0.395|1.395|||Regression, Linear|||Heart rate delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure|
1620088|NCT02326649|2976607|Other||Mean Difference (Final Values)|6.561|Standard Error of the Mean|5.528||0.255|2-Sided|95.0|-5.295|18.417|||Regression, Linear|||Intercept for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure|
1620089|NCT02326649|2976607|Other|||||||0.47|||||||paired t-test||||
1620121|NCT02326220|2976651|Superiority||LS Mean Difference|-44.0|||<|0.0001|2-Sided|95.0|-51.3|-36.6||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1620090|NCT02326298|2976618|Superiority||Ajusted Mean Treatment Differences|-6.84|||<|0.0001|2-Sided|97.5|-9.05|-4.62||P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620091|NCT02326298|2976618|Superiority||Adjusted Mean Treatment Differences|-6.0|||<|0.0001|2-Sided|97.5|-8.18|-3.81||P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620092|NCT02326298|2976619|Superiority||Estimated difference in responder rate|43.1|||||2-Sided|95.0|27.56|58.71|||||Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620093|NCT02326298|2976619|Superiority||Estimated difference in responder rate|35.4|||||2-Sided|95.0|20.85|49.87|||||Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620094|NCT02326298|2976619|Superiority||Odds Ratio (OR)|50.606|||<|0.0001|2-Sided|97.5|7.88|324.988||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620095|NCT02326298|2976619|Superiority||Odds Ratio (OR)|36.668|||<|0.0001|2-Sided|97.5|5.717|235.193||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment,region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620096|NCT02326298|2976620|Superiority||Estimated difference in responder rate|53.6|||||2-Sided|95.0|41.33|65.94|||||Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620097|NCT02326298|2976620|Superiority||Estimated difference in responder rate|42.8|||||2-Sided|95.0|30.7|54.86|||||Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620098|NCT02326298|2976620|Superiority||Odds Ratio (OR)|31.143|||<|0.0001|2-Sided|97.5|5.687|170.548||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620099|NCT02326298|2976620|Superiority||Odds Ratio (OR)|20.116|||<|0.0001|2-Sided|97.5|3.699|109.399||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620100|NCT02326298|2976621|Superiority||Estimated difference in responder rate|69.3|||||2-Sided|95.0|57.65|80.99|||||Estimate and 95% CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620101|NCT02326298|2976621|Superiority||Estimated difference in responder rate|60.0|||||2-Sided|95.0|47.92|72.17|||||Estimate and 95% CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).|The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620102|NCT02326298|2976621|Superiority||Odds Ratio (OR)|45.66|||<|0.0001|2-Sided|97.5|10.657|195.634||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620103|NCT02326298|2976621|Superiority||Odds Ratio (OR)|28.962|||<|0.0001|2-Sided|97.5|6.968|120.371||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620122|NCT02326220|2976652|Superiority||H-L estimate of median difference|0.5|||<|0.0001|2-Sided|95.0|0.5|1.0||Threshold for significance at 0.05 level.|ANCOVA||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1620104|NCT02326272|2976622|Superiority||Adjusted Mean Treatment Differences|-6.19|||<|0.0001|2-Sided|97.5|-8.46|-3.93||The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620105|NCT02326272|2976622|Superiority||Adjusted Mean Treatment Differences|-6.62|||<|0.0001|2-Sided|97.5|-8.88|-4.36||The P-value was obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.|ANCOVA|ANCOVA model of change from Baseline DLQI score with treatment group, region, prior biologic exposure as factors; Baseline DLQI score as a covariate.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620106|NCT02326272|2976625|Superiority||Estimated difference in responder rate|51.0|||||2-Sided|95.0|37.75|64.19||||||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620107|NCT02326272|2976625|Superiority||Odds Ratio (OR)|27.204|||<|0.0001|2-Sided|97.5|4.895|151.198||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620108|NCT02326272|2976625|Superiority||Estimated difference in responder rate|48.1|||<||2-Sided|95.0|35.04|61.26||||||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620109|NCT02326272|2976625|Superiority||Odds Ratio (OR)|24.283|||<|0.0001|2-Sided|97.5|4.386|134.432||The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620110|NCT02326272|2976626|Superiority||Estimated difference in responder rate|69.6|||||2-Sided|95.0|57.48|81.77||||||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620111|NCT02326272|2976626|Superiority||Odds Ratio (OR)|133.163|||<|0.0001|2-Sided|97.5|11.904|1489.578||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620112|NCT02326272|2976626|Superiority||Estimated difference in responder rate|64.8|||<||2-Sided|95.0|52.16|77.46||||||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620113|NCT02326272|2976626|Superiority||Odds Ratio (OR)|106.225|||<|0.0001|2-Sided|97.5|9.572|1178.843||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620114|NCT02326272|2976627|Superiority||Estimated difference in responder rate|71.0|||||2-Sided|95.0|58.47|83.43||||||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620115|NCT02326272|2976627|Superiority||Odds Ratio (OR)|36.212|||<|0.0001|2-Sided|97.5|10.686|122.713||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620116|NCT02326272|2976627|Superiority||Estimated difference in responder rate|69.7|||<||2-Sided|95.0|57.12|82.36||||||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620117|NCT02326272|2976627|Superiority||Odds Ratio (OR)|33.405|||<|0.0001|2-Sided|97.5|9.965|111.983||The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) placebo (PBO).|Regression, Logistic|Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.||The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.|
1620118|NCT02326220|2976648|Superiority||LS Mean Difference|4.2||||0.3012|2-Sided|95.0|-3.9|12.3||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1620119|NCT02326220|2976649|Superiority||LS Mean Difference|-39.4|||<|0.0001|2-Sided|95.0|-45.6|-33.2||Threshold for significance at 0.05 level.|MMRM||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1620153|NCT02323646|2976834|Superiority|||||||0.7891|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620553|NCT02314546|2977585|Superiority or Other|||||||0.26|||||||Kruskal-Wallis||||
1620123|NCT02326220|2976653|Superiority||Least Square (LS) Mean Difference|-55.3|Standard Error of the Mean|3.9|<|0.0001|2-Sided|95.0|-63.0|-47.5||Threshold for significance at 0.05 level.|MMRM|MMRM: Mixed-effect model with repeated measures|Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|
1620124|NCT02326220|2976654|Superiority||H-L estimate of median difference|0.75|||<|0.0001|2-Sided|95.0|0.667|0.833||Threshold for significance at 0.05 level.|ANCOVA||Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period)|"Analysis was performed using the ranked analysis of covariance (ANCOVA) model with baseline frequency of the apheresis procedure (QW or Q2W) and Lp(a) levels (normal or elevated) as fixed effect and the baseline LDL-C level as a covariate. Hodges-Lehmann estimator of median difference (median of all pairwise differences; CI is Moses distribution free CI.~p-value is derived from the rank-based ANCOVA model. The model includes the baseline LDL-C value and stratification factors per IVRS."|
1620125|NCT02326025|2976661|Superiority||Ratio of LS Means|1.03|||||2-Sided|90.0|0.801|1.33|||||||
1620126|NCT02326025|2976661|Superiority||Ratio of LS Means|0.944|||||2-Sided|90.0|0.77|1.16|||||||
1620127|NCT02326025|2976662|Superiority||Ratio of LS Means|1.03|||||2-Sided|90.0|0.957|1.11|||||||
1620128|NCT02326025|2976662|Superiority||Ratio of Geometric LS Means|1.04|||||2-Sided|90.0|0.964|1.13|||||Log(PK) is participant and treatment and random error, where participant is fitted as a random effect.||
1620129|NCT02325791|2976665|Superiority||percentage treatment difference|2.02|||||2-Sided|95.0|-2.836|6.867||||||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) & gestational age category (<= 31 weeks 6 days GA vs >= 32 weeks 0 days and <= 35 weeks 6 days GA). Threshold for significance at 0.05 level.|
1620130|NCT02325791|2976665|Superiority||percentage treatment difference|-0.67|||||2-Sided|95.0|-5.291|3.959||||||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) & gestational age category (<= 31 weeks 6 days GA vs >= 32 weeks 0 days and <= 35 weeks 6 days GA). Threshold for significance at 0.05 level.|
1620131|NCT02325791|2976669|Superiority||percentage treatment difference|-0.44|||||2-Sided|95.0|-4.318|3.438||||||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each Suptavumab dose regimen to placebo. Missing values were imputed to Kaplan-Meier (KM) estimate from the placebo group. Randomization strata adjusted in Cochran-Mantel-Haenszel (CMH) test include region (North America vs. Rest of World) & gestational age category (<= 31 weeks 6 days GA vs >= 32 weeks 0 days and <= 35 weeks 6 days GA). Threshold for significance at 0.05 level.|
1620132|NCT02325791|2976669|Superiority||percentage treatment difference|1.15||||0.5773|2-Sided|95.0|-2.898|5.201|||Cochran-Mantel-Haenszel|||A hierarchical inferential approach was used to control Type-1 error at 0.05 for pairwise comparisons of each suptavumab dose regimen to placebo. Missing values were imputed to KM estimate from the placebo group. Randomization strata adjusted in CMH test include region (North America vs. Rest of World) & gestational age category (<= 31 weeks 6 days GA vs >= 32 weeks 0 days and <= 35 weeks 6 days GA). Threshold for significance at 0.05 level.|
1620133|NCT02325713|2976685|Superiority or Other||Geometric LS mean ration|82.1|||||2-Sided|90.0|68.5|98.3|||||||
1620134|NCT02325713|2976685|Superiority or Other||Geometric LS mean ration|238.1|||||2-Sided|90.0|198.7|285.3|||||||
1620135|NCT02325713|2976685|Superiority or Other||Geometric LS mean ration|222.7|||||2-Sided|90.0|186.8|265.6|||||||
1620136|NCT02325713|2976685|Superiority or Other||Geometric LS mean ration|18.4|||||2-Sided|90.0|15.3|22.0|||||||
1620137|NCT02325713|2976685|Superiority or Other||Geometric Least square (LS) mean ratio|96.2|||||2-Sided|90.0|83.7|110.6|||||||
1620138|NCT02325219|2976740|Superiority||||||<|0.001|||||||Fisher Exact||||
1620139|NCT02325219|2976740|Superiority||||||<|0.001|||||||Fisher Exact||||
1620140|NCT02325219|2976741|Superiority||||||<|0.001|||||||Fisher Exact||||
1620141|NCT02325219|2976741|Superiority||||||<|0.001|||||||Fisher Exact||||
1620142|NCT02324972|2976742|Superiority or Other||Mean Difference (Final Values)|2.52||||0.233|2-Sided|95.0|-1.68|6.72|||ANOVA||||
1620143|NCT02324972|2976743|Superiority or Other||Mean Difference (Final Values)|0.108||||0.976|2-Sided|95.0|-7.076|7.292|||ANOVA||||
1620144|NCT02324972|2976744|Superiority or Other||Mean Difference (Final Values)|-0.219||||0.802|2-Sided|95.0|-1.983|1.544|||ANOVA||||
1620145|NCT02324972|2976745|Superiority or Other||Mean Difference (Final Values)|0.12||||0.677|2-Sided|95.0|-0.44|0.68|||ANOVA||||
1620146|NCT02324972|2976746|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.636|2-Sided|95.0|-1.3|1.25|||ANCOVA|||A sample size of 20 subjects per group was assumed to have 80% power to allow detection of a statistically significant difference in change from baseline in TLSS between the 2 groups, if the effect size was approximately less than or equal to 0.9. This is equivalent to detecting a difference of -4.5 between the 2 groups with a common standard deviation of 5. The primary analysis was doing using last observation carried forward (LOCF) imputed data.|
1620147|NCT02324569|2976805|Superiority||Least square (LS) mean difference|-0.63|Standard Error of the Mean|0.097|<|0.0001|2-Sided|95.0|-0.826|-0.443|||ANCOVA||||
1620148|NCT02323646|2976833|Superiority|||||||0.8314|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620149|NCT02323646|2976833|Superiority|||||||0.0442|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620150|NCT02323646|2976833|Superiority|||||||0.1934|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620151|NCT02323646|2976833|Superiority|||||||0.0294|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620152|NCT02323646|2976834|Superiority|||||||0.401|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620554|NCT02314546|2977586|Superiority or Other|||||||0.99|||||||Chi-squared||||
1620158|NCT02323646|2976835|Superiority|||||||0.726|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620159|NCT02323646|2976835|Superiority|||||||0.6929|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620160|NCT02323646|2976835|Superiority|||||||0.5503|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620161|NCT02323646|2976835|Superiority|||||||0.3167|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620162|NCT02323646|2976835|Superiority|||||||0.8177|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620163|NCT02323646|2976835|Superiority|||||||0.817|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620164|NCT02323646|2976836|Superiority|||||||0.9302|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620165|NCT02323646|2976836|Superiority|||||||0.6266|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620166|NCT02323646|2976836|Superiority|||||||0.9102|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620167|NCT02323646|2976836|Superiority|||||||0.9396|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620168|NCT02323646|2976836|Superiority|||||||0.1355|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620169|NCT02323646|2976836|Superiority|||||||0.9536|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620170|NCT02323646|2976837|Superiority|||||||0.4602|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620171|NCT02323646|2976837|Superiority|||||||0.541|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620172|NCT02323646|2976837|Superiority|||||||0.392|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620173|NCT02323646|2976837|Superiority|||||||1|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620174|NCT02323646|2976837|Superiority|||||||0.1928|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620175|NCT02323646|2976837|Superiority|||||||0.7949|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620176|NCT02323646|2976838|Superiority|||||||0.137|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620177|NCT02323646|2976838|Superiority|||||||0.8237|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620178|NCT02323646|2976838|Superiority|||||||0.6273|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620179|NCT02323646|2976838|Superiority|||||||0.0382|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620180|NCT02323646|2976838|Superiority|||||||0.1361|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620181|NCT02323646|2976838|Superiority|||||||0.8393|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620182|NCT02323646|2976839|Superiority|||||||0.3847|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620183|NCT02323646|2976839|Superiority|||||||0.3086|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620184|NCT02323646|2976839|Superiority|||||||0.2678|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620185|NCT02323646|2976839|Superiority|||||||0.5219|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620186|NCT02323646|2976839|Superiority|||||||0.9539|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620187|NCT02323646|2976839|Superiority|||||||0.6356|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620188|NCT02323646|2976840|Superiority|||||||0.3847|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620189|NCT02323646|2976840|Superiority|||||||0.0323|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620190|NCT02323646|2976840|Superiority|||||||0.1334|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620191|NCT02323646|2976840|Superiority|||||||0.4997|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620192|NCT02323646|2976840|Superiority|||||||0.256|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620193|NCT02323646|2976840|Superiority|||||||0.1683|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620194|NCT02323646|2976841|Superiority|||||||0.5399|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620195|NCT02323646|2976841|Superiority|||||||0.7569|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2, Week 24 Follow-up Visit|
1620196|NCT02323646|2976841|Superiority|||||||0.0233|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620197|NCT02323646|2976841|Superiority|||||||0.0749|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620198|NCT02323646|2976841|Superiority|||||||0.0191|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620199|NCT02323646|2976841|Superiority|||||||0.0473|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620200|NCT02323646|2976842|Superiority|||||||0.345|||||||Wilcoxon Rank-Sum Test|||Percentage Change: Course 2, Week 24 Follow-up|
1620201|NCT02323646|2976842|Superiority|||||||0.3666|||||||Wilcoxon Rank-Sum Test|||Percentage Change: Course 2, Week 24 Follow-up|
1620202|NCT02323646|2976842|Superiority|||||||0.8791|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620203|NCT02323646|2976842|Superiority|||||||0.5333|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 2|
1620204|NCT02323646|2976842|Superiority|||||||0.4383|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620205|NCT02323646|2976842|Superiority|||||||0.2642|||||||Wilcoxon Rank-Sum Test|||Percentage Change from BL: Course 1|
1620206|NCT02323646|2976843|Superiority|||||||0.0296|||||||Wilcoxon Rank-Sum Test|||Percentage change in the last value on drug Course 2.|
1620555|NCT02314546|2977587|Superiority or Other|||||||0.99|||||||Chi-squared||||
1620207|NCT02323646|2976843|Superiority|||||||0.0061|||||||Wilcoxon Rank-Sum Test|||Percentage change in the last value on drug Course 2.|
1620208|NCT02323646|2976843|Superiority|||||||0.0662|||||||Wilcoxon Rank-Sum Test.|||Percentage change in the last value on drug Course 1.|
1620209|NCT02323646|2976843|Superiority|||||||0.0145|||||||Wilcoxon Rank-Sum Test.|||Percentage change in the last value on drug Course 1.|
1620210|NCT02323646|2976844|Superiority|||||||0.0272|||||||Fisher Exact||||
1620211|NCT02323646|2976844|Superiority|||||||0.0237|||||||Fisher Exact||||
1620212|NCT02323646|2976845|Superiority|||||||0.0063|||||||Fisher Exact||||
1620213|NCT02323646|2976845|Superiority|||||||0.0019|||||||Fisher Exact||||
1620214|NCT02323204|2976846|Other|||||||0.0003|||||||Wald 2-sided t-test|||A Generalized Linear Mixed Model (GLMM) with cumulative logit link and multinomial distribution was fit to the data. A comparison of implementation between interventions was made through the intervention main effect included in the model. The model at hand does not contain an interaction between intervention and time. Significance in the main intervention effect is indicative of a difference in implementation between intervention groups.|
1620215|NCT02323204|2976846|Other|||||||0.7949|||||||Wald 2-sided t-test|||A Generalized Linear Mixed Model (GLMM) with cumulative logit link and multinomial distribution was fit to the data. A comparison of implementation over time between interventions was made through the intervention-time interaction effect included in the model. Significance in the interaction effect is indicative of a difference in the rate of change in implementation between interventions over time.|
1620216|NCT02323204|2976847|Other|||||||0.4635|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620217|NCT02323204|2976847|Other|||||||0.5824|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620218|NCT02323204|2976848|Other|||||||0.2568|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620219|NCT02323204|2976848|Other|||||||0.0325|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620220|NCT02323204|2976849|Other|||||||0.0982|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620221|NCT02323204|2976849|Other|||||||0.9928|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620222|NCT02323204|2976850|Other|||||||0.0201|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620223|NCT02323204|2976850|Other|||||||0.0286|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620224|NCT02323204|2976851|Other|||||||0.7957|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620225|NCT02323204|2976851|Other|||||||0.0654|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620226|NCT02323204|2976852|Other|||||||0.0769|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620343|NCT02320903|2977022|Equivalence|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.22.
1620227|NCT02323204|2976852|Other|||||||0.1507|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620228|NCT02323204|2976853|Other|||||||0.5381|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620229|NCT02323204|2976853|Other|||||||0.6756|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620230|NCT02323204|2976854|Other|||||||0.4501|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620231|NCT02323204|2976854|Other|||||||0.7166|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620232|NCT02323204|2976855|Other|||||||0.2951|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620233|NCT02323204|2976855|Other|||||||0.7893|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620234|NCT02323204|2976856|Other|||||||0.2341|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620235|NCT02323204|2976856|Other|||||||0.6298|||||||Wald 2-sided t-test|||"A Generalized Linear Mixed Model (GLMM) with log link and gamma distribution was fit to five imputed data sets. Obtained estimates and standard errors were adjusted accordingly.~A comparison of intervention efficacy was made through the intervention-time interaction effect included in the model. Statistical significance of the interaction effect is indicative of a difference in effect between interventions over time."|
1620236|NCT02322879|2976869|Superiority|||||||0.59|||||||Chi-squared||||
1620237|NCT02322866|2976870|Superiority||Least Squares Mean Difference|-2.9|||<|0.0001|2-Sided|95.0|-4.1|-1.7||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3|
1620238|NCT02322866|2976871|Superiority||Least Squares Mean Difference|-3.7|||<|0.0001|2-Sided|95.0|-5.0|-2.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6|
1620239|NCT02322866|2976872|Superiority||Least Squares Mean Difference|-3.8|||<|0.0001|2-Sided|95.0|-5.2|-2.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9|
1620240|NCT02322866|2976873|Superiority||Least Squares Mean Difference|-9.4|||<|0.0001|2-Sided|95.0|-13.5|-5.3||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3|
1620241|NCT02322866|2976874|Superiority||Least Squares Mean Difference|-11.8|||<|0.0001|2-Sided|95.0|-16.1|-7.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6|
1620242|NCT02322866|2976875|Superiority||Least Squares Mean Difference|-12.6|||<|0.0001|2-Sided|95.0|-17.3|-7.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9|
1620243|NCT02322866|2976876|Superiority||Least Squares Mean Difference|-14.4|||<|0.0001|2-Sided|95.0|-19.4|-9.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12|
1620244|NCT02322866|2976877|Superiority||Treatment Rate Difference|7.3||||0.0038|2-Sided|95.0|2.53|12.07||P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.|Cochran-Mantel-Haenszel||sarecycline - placebo||
1620344|NCT02320903|2977023|Equivalence|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.23.
1620245|NCT02322866|2976878|Superiority||Least Squares Mean Difference|-4.4|||<|0.0001|2-Sided|95.0|-5.8|-2.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo||
1620246|NCT02322788|2976899|Non-Inferiority or Equivalence|The details of the sample size calculation is document at Section 8.2 the study protocol.|Estimated mean ratio|0.88|||||2-Sided|95.0|0.72|1.08||||||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.|
1620247|NCT02322788|2976899|Non-Inferiority or Equivalence|The details of the sample size calculation is document at Section 8.2 the study protocol.|Estimated mean ratio|0.92|||||2-Sided|95.0|0.75|1.13||||||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.|
1620248|NCT02322788|2976899|Superiority or Other||Estimated mean ratio|1.79|||<|0.001|2-Sided|95.0|1.46|2.2|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.|
1620249|NCT02322788|2976899|Superiority or Other||Estimated mean ratio|1.87|||<|0.001|2-Sided|95.0|1.52|2.29|||Mixed Models Analysis|||A linear mixed effect model based on restricted maximum likelihood analysis is used to estimate the treatment effect. PC20 in natural log scale is the response variable, treatment and period are the fixed effects, and patient within sequence is a random effect.|
1620250|NCT02322775|2976902|Superiority or Other||Difference of Least Square Means|0.19||||0.135|2-Sided|95.0|-0.06|0.44||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Environmental stimuli score|
1620251|NCT02322775|2976902|Superiority or Other||Difference of Least Square Means|0.19||||0.156|2-Sided|95.0|-0.07|0.45||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Emotional function score|
1620252|NCT02322775|2976902|Superiority or Other||Difference of Least Square Means|0.2||||0.061|2-Sided|95.0|-0.01|0.41||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Activity limitation score|
1620253|NCT02322775|2976902|Superiority or Other||Difference of Least Square Means|0.23||||0.063|2-Sided|95.0|-0.01|0.47||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Symptoms score|
1620254|NCT02322775|2976902|Superiority or Other||Difference of Least Square Means|0.21||||0.055|2-Sided|95.0|0.0|0.42||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|ANCOVA|||Parameter: Total score|
1620255|NCT02322775|2976904|Superiority or Other||Difference of Least Square Means|-0.17||||0.114|2-Sided|95.0|-0.39|0.04||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis||||
1620256|NCT02322775|2976905|Superiority or Other||Difference of Least Square Means|-0.03||||0.38|2-Sided|95.0|-0.08|0.03||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis||||
1620257|NCT02322775|2976906|Superiority or Other||Difference of Least Square Means|-0.36||||0.2|2-Sided|95.0|-0.91|0.19||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis||||
1620258|NCT02322775|2976907|Superiority or Other||Difference of Least Square Means|-0.13||||0.266|2-Sided|95.0|-0.35|0.1||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis||||
1620259|NCT02322775|2976908|Superiority or Other||Difference of Least Square Means|5.29||||0.456|2-Sided|95.0|-8.67|19.25||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis||||
1620260|NCT02322775|2976909|Superiority or Other||Difference of Least Square Means|8.84||||0.233|2-Sided|95.0|-5.74|23.42||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis||||
1620261|NCT02322775|2976910|Superiority or Other||Difference of Least Square Means|0.08||||0.04|2-Sided|95.0|0.0|0.15||Hypothesis testing were reported using 2-sided 5% level tests with nominal p-values (i.e., not adjusted for multiplicity).|Mixed Models Analysis|||The null hypothesis was: H0: Change from baseline in pre-bronchodilator FEV1 (L) at Week 12 (benralizumab vs placebo)=0.|
1620262|NCT02322749|2976911|Superiority or Other||Geometric LS Mean Ratio|12.8|||||2-Sided|90.0|11.07|14.8|||||N-desmethyl selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.||
1620263|NCT02322749|2976911|Superiority or Other||Geometric LS Mean Ratio|11.31|||||2-Sided|90.0|9.8|13.05|||||N-desmethyl selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.||
1620264|NCT02322749|2976912|Superiority or Other||Geometric LS Mean Ratio|13.04|||||2-Sided|90.0|11.45|14.86|||||N-desmethyl selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.||
1620265|NCT02322749|2976912|Superiority or Other||Geometric LS Mean Ratio|9.66|||||2-Sided|90.0|8.5|10.97|||||N-desmethyl selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect||
1620266|NCT02322749|2976913|Superiority or Other||Geometric LS Mean Ratio|23.6|||||2-Sided|90.0|22.02|25.3|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.||
1620449|NCT02319148|2977187|Superiority or Other||Ratio of adjusted geometric means|90.16|||||2-Sided|90.0|78.57|103.46|||||||
1620267|NCT02322749|2976914|Superiority or Other||Geometric LS Mean Ratio|26.2|||||2-Sided|90.0|24.44|28.09|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.||
1620268|NCT02322749|2976915|Superiority or Other||Geometric LS Mean Ratio|12.93|||||2-Sided|90.0|11.42|14.65|||||Selumetinib: Ratio of Treatment C to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.||
1620269|NCT02322749|2976916|Non-Inferiority or Equivalence|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric LS mean ratio|22.12|||||2-Sided|90.0|20.65|23.69|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.||
1620270|NCT02322749|2976917|Non-Inferiority or Equivalence|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric LS Mean Ratio|24.26|||||2-Sided|90.0|22.62|26.03|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.||
1620271|NCT02322749|2976918|Non-Inferiority or Equivalence|If the 90% confidence intervals for both AUC and Cmax were entirely contained within the limits 80.00% to 125.00% then bioequivalence was concluded.|Geometric Least Squares (LS) Mean Ratio|9.32|||||2-Sided|90.0|8.25|10.53|||||Selumetinib: Ratio of Treatment B to Treatment A based on a linear mixed-effects model with sequence, period, and treatment as fixed effects and volunteer nested within sequence as a random effect.||
1620272|NCT02322710|2976919|Non-Inferiority|Non-inferiority was demonstrated if the upper limit of the 95% confidence interval of the observed difference between healing rates at D21 (Urgotul® - Tullegras M.S.®) in the PP population did not exceed +10%.|Difference in Percentages|1.2|Standard Deviation|4.5|||1-Sided|97.5||10.0|||||||
1620273|NCT02322320|2976930|Superiority|||||||0.7||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.|
1620274|NCT02322320|2976930|Superiority|||||||0.7||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.|
1620275|NCT02322320|2976930|Superiority|||||||0.43||||||The analysis involved pairwise comparisons of SPM between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Gray's test|Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with SPM at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.|
1620276|NCT02322320|2976931|Superiority|||||||0.4||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.|
1620277|NCT02322320|2976931|Superiority|||||||0.2||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.|
1620278|NCT02322320|2976931|Superiority|||||||0.67||||||The analysis involved pairwise comparisons of EFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with EFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.|
1620279|NCT02322320|2976932|Superiority|||||||0.77||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.|
1620280|NCT02322320|2976932|Superiority|||||||0.38||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.|
1620345|NCT02320903|2977023|Equivalence|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.62.
1620281|NCT02322320|2976932|Superiority|||||||0.57||||||The analysis involved pairwise comparisons of OS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.|
1620282|NCT02322320|2976933|Superiority|||||||0.68||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.|
1620283|NCT02322320|2976933|Superiority|||||||0.35||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.|
1620284|NCT02322320|2976933|Superiority|||||||0.6||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.|
1620285|NCT02321930|2976950|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months|
1620286|NCT02321930|2976951|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months|
1620287|NCT02321930|2976952|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months|
1620288|NCT02321930|2976953|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months|
1620289|NCT02321930|2976954|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Analysis performed to test for the change in values from Baseline to 3 months|
1620290|NCT02321800|2976962|Other||Treatment Difference|9.02|||||2-Sided|95.0|-0.37|18.41||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.|
1620291|NCT02321800|2976963|Other||Treatment Difference|-1.07|||||2-Sided|95.0|-3.42|1.29||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.|
1620292|NCT02321800|2976964|Other||Treatment Difference|-0.26|||||2-Sided|95.0|-6.57|6.05||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.|
1620293|NCT02321800|2976965|Other||Treatment Difference|2.39|||||2-Sided|95.0|-4.66|9.44||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.|
1620294|NCT02321800|2976970|Other||Treatment Difference|13.92|||||2-Sided|95.0|3.21|24.63||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.|
1620295|NCT02321800|2976971|Other||Treatment Difference|1.1|||||2-Sided|95.0|-3.04|5.25||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.|
1620296|NCT02321800|2976972|Other||Treatment Difference|1.28|||||2-Sided|95.0|-4.83|7.39||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.|
1620297|NCT02321800|2976973|Other||Treatment Difference|17.25|||||2-Sided|95.0|6.92|27.58||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.|
1620298|NCT02321800|2976974|Other||Treatment Difference|15.31|||||2-Sided|95.0|4.69|25.92|||||||
1620299|NCT02321800|2976975|Other||Treatment Difference|0.72|||||2-Sided|95.0|-3.48|4.92||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.|
1620300|NCT02321800|2976976|Other||Treatment Difference|0.66|||||2-Sided|95.0|-6.48|7.79||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.|
1620301|NCT02321800|2976977|Non-Inferiority|The margin of noninferiority was 20%. Noninferiority was concluded if the lower bound of a 2-sided 95% CI for the difference in response rates between the 2 treatment groups was greater than -20%. If the noninferiority inference based on the 20% margin was concluded successfully, noninferiority inference based on the 15% margin was performed.|Treatment Difference|18.58|||||2-Sided|95.0|8.23|28.92||||||Adjusted estimates of the difference between the two treatment groups are based on a stratified analysis using Cochran-Mantel-Haenszel weights, with clinical diagnosis (complicated urinary tract infection with or without pyelonephritis vs acute uncomplicated pyelonephritis) as the stratification factor.|
1620302|NCT02321462|2976996|Superiority||Adjusted difference|13.35|||=|0|2-Sided|95.0|6.37|20.32|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; >65), gender and IBD status was used.|||
1620303|NCT02321462|2976997|Superiority||Adjusted difference|0.1|||=|0|2-Sided|95.0|-0.05|0.25|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; >65), gender and IBD status was used.|||
1620304|NCT02321462|2976998|Superiority||Adjusted difference|-0.3|||=|0|2-Sided|95.0|-1.88|1.27|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; >65), gender and IBD status was used.|||
1620305|NCT02321462|2976999|Superiority||Adjusted difference|0.01|||=|0|2-Sided|95.0|-3.12|3.14|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; >65), gender and IBD status was used.|||
1620306|NCT02321462|2977000|Superiority||Adjusted difference|-1.55|||=|0|2-Sided|95.0|-9.64|6.54|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; >65), gender and IBD status was used.||Treatment difference for detection of other lesions.|
1620307|NCT02321462|2977000|Superiority||Adjusted difference|1.87|||=|0|2-Sided|95.0|-6.25|9.99|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; >65), gender and IBD status was used.||Treatment difference for detection of adenomas.|
1620308|NCT02321462|2977000|Superiority||Adjusted difference|-6.94|||=|0|2-Sided|95.0|-17.53|3.64|||Regression, Logistic|A multivariate logistic regression model, adjusted on centre, age class (≤65; >65), gender and IBD status was used.||Treatment difference for detection of polyps.|
1620309|NCT02321462|2977001|Superiority||Treatment difference|0.08|||=|0|2-Sided|95.0|-0.02|0.18|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; >65), gender and IBD status was used.||Treatment difference for Transverse Colon BBPS Score (per protocol population).|
1620310|NCT02321462|2977001|Superiority||Adjusted difference|0.11|||=|0|2-Sided|95.0|-0.02|0.24|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; >65), gender and IBD status was used.||Treatment difference for Right Colon BBPS Score (per protocol population).|
1620311|NCT02321462|2977002|Superiority||Adjusted difference|0.33|||=|0|2-Sided|95.0|0.04|0.62|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; >65), gender and IBD status was used.||Treatment difference for Global BBPS Score.|
1620312|NCT02321462|2977002|Superiority||Adjusted difference|0.06|||=|0|2-Sided|95.0|-0.04|0.16|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; >65), gender and IBD status was used.||Treatment difference for Left Colon BBPS Score.|
1620313|NCT02321462|2977002|Superiority||Adjusted difference|0.11|||=|0|2-Sided|95.0|0.01|0.22|||ANOVA|A 2-way ANOVA with covariates for centre, age group (≤65; >65), gender and IBD status was used.||Treatment difference for Transverse Colon BBPS Score.|
1620314|NCT02321462|2977002|Superiority||Adjusted difference|0.15|||=|0|2-Sided|95.0|0.02|0.28|||ANOVA|A 2-way analysis of variance model (ANOVA) with covariates for centre, age group (≤65; >65), gender and IBD status was used.||Treatment difference for Right Colon BBPS Score.|
1620315|NCT02321462|2977003|Non-Inferiority|Non-inferiority would be demonstrated if the lower limit of the 95% confidence intervals (CI) of the difference was higher than the predefined noninferiority margin (-15%).|Adjusted difference|-0.46|||||2-Sided|95.0|-4.22|3.29|||||To investigate noninferiority of Eziclen compared to Fortrans®, the adjusted difference between these 2 groups was calculated with 95% CI of the adjusted difference.|A multivariate logistic regression model, adjusted on centre, age class (≤65; >65), gender and IBD status (No IBD, IBD) was used.|
1620316|NCT02321436|2977006|Other|||||||0.6128||||||The Cochran-Mantel-Haenszel (CMH) p-value represents the strength of the association between treatment and global assessments of changes at the last visit, adjusted for symptomatic status at baseline.|Cochran-Mantel-Haenszel|p value significance level = 5%|||
1620317|NCT02321436|2977007|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-4.5||||0.731|2-Sided|95.0|-33.3|24.3||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 10 (Week 28).|
1620318|NCT02321436|2977007|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-9.0||||0.4311|2-Sided|95.0|-33.7|15.7||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 9 (Week 24).|
1620319|NCT02321436|2977007|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-14.1||||0.2441|2-Sided|95.0|-39.4|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 8 (Week 20).|
1620320|NCT02321436|2977007|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-12.5||||0.2325|2-Sided|95.0|-34.0|9.0||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 7 (Week 16).|
1620321|NCT02321436|2977007|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|4.6||||0.5646|2-Sided|95.0|-11.9|21.2||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 6 (Week 12).|
1620732|NCT02312687|2977738|Superiority||LS Mean|0.0|||||2-Sided|95.0|-0.02|0.02||||||Change at Week 72|
1620322|NCT02321436|2977007|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.1||||0.9882|2-Sided|95.0|-13.0|12.8||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 5 (Week 10).|
1620323|NCT02321436|2977007|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-2.2||||0.6992|2-Sided|95.0|-14.0|9.6||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 4 (Week 8).|
1620324|NCT02321436|2977007|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.9||||0.8805|2-Sided|95.0|-12.8|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 3 (Week 6).|
1620325|NCT02321436|2977007|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|0.8||||0.8754|2-Sided|95.0|-9.5|11.1||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 2 (Week 4).|
1620326|NCT02321436|2977008|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.21||||0.6582|2-Sided|95.0|-1.24|0.81||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 10 (Week 28).|
1620327|NCT02321436|2977008|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.12||||0.8521|2-Sided|95.0|-1.46|1.23||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 9 (Week 24).|
1620328|NCT02321436|2977008|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.15||||0.7656|2-Sided|95.0|-1.25|0.94||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 8 (Week 20).|
1620329|NCT02321436|2977008|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.52||||0.2037|2-Sided|95.0|-1.35|0.31||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 7 (Week 16).|
1620330|NCT02321436|2977008|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.83||||0.0052|2-Sided|95.0|-1.39|-0.26||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 6 (Week 12).|
1620331|NCT02321436|2977008|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-0.84||||0.0027|2-Sided|95.0|-1.36|-0.31||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 5 (Week 10).|
1620332|NCT02321436|2977008|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.05||||0.0006|2-Sided|95.0|-1.62|-0.48||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 4 (Week 8).|
1620333|NCT02321436|2977008|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.05||||0.0007|2-Sided|95.0|-1.63|-0.47||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 3 (Week 6).|
1620334|NCT02321436|2977008|Other|Differences between treatment groups and p-values are based on an analysis of variance performed at each visit, taking into account treatment and spasticity status as fixed effects. Baseline value is value assessed at Visit 1.|Mean Difference (Final Values)|-1.0||||0.0005|2-Sided|95.0|-1.54|-0.47||p value significance level = 5%|ANOVA|||Differences between treatment groups at Visit 2 (Week 4).|
1620335|NCT02321436|2977009|Other|The treatment difference (Dysport® versus placebo) was tested using a non-parametric, two-sided, stratified Wilcoxon test.||||||0.048||||||Significance level (α) = 5%|Wilcoxon (Mann-Whitney)||||
1620336|NCT02321436|2977009|Other|The treatment difference (Dysport® versus placebo) was tested using a non-parametric, two-sided, stratified log rank test.||||||0.0176||||||Significance level (α) = 5%|Log Rank||||
1620337|NCT02321111|2977015|Other|ANOVA||||||0.02|||||||ANOVA||||
1620338|NCT02320903|2977018|Equivalence|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for youth report on this measure was d = 24.
1620339|NCT02320903|2977019|Equivalence|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.43.
1620340|NCT02320903|2977020|Equivalence|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.81.
1620341|NCT02320903|2977021|Equivalence|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d =.12.
1620342|NCT02320903|2977022|Equivalence|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired samples T tests were used to measure within-groups change over time for teens.|Cohen's d for youth report was d = 0.26.
1620346|NCT02320903|2977024|Equivalence|What was the within-group change over time effect size? (Cohen's d)||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for youth report was d = 0.21.
1620347|NCT02320903|2977024|Equivalence|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.16.
1620348|NCT02320903|2977025|Equivalence|What was the within-group change over time effect size? (Cohen's d)||||||||||||||||Paired samples T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.28.
1620349|NCT02320903|2977025|Equivalence|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.10.
1620350|NCT02320903|2977026|Other|What was the within-group change over time effect size?||||||||||||||||Paired sample T tests were used to measure change for teens over time.|Cohen's d for teen report on this measure was d = 0.22.
1620351|NCT02320903|2977026|Equivalence|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was d = 0.22.
1620352|NCT02320903|2977027|Equivalence|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change over time for teens.|Cohen's d for youth report was d = 0.22.
1620353|NCT02320903|2977027|Equivalence|What was the within-group change over time effect size (Cohen's d)?||||||||||||||||Paired sample T tests were used to measure change for parents over time.|Cohen's d for parent report on this measure was 0.16.
1620354|NCT02320838|2977039|Other|||||||1||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620355|NCT02320838|2977040|Other|||||||0.2||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620356|NCT02320838|2977041|Other|||||||0.1||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620357|NCT02320838|2977042|Other|||||||0.6||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620358|NCT02320838|2977043|Other|||||||0.5||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620359|NCT02320838|2977044|Other|||||||0.9||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620360|NCT02320838|2977045|Other|||||||0.9||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620361|NCT02320838|2977046|Other|||||||0.1||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620362|NCT02320838|2977047|Other|||||||0.4||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620363|NCT02320838|2977048|Other|||||||1||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620364|NCT02320838|2977049|Other|||||||0.8|||||||ANOVA||||
1620365|NCT02320838|2977050|Other|||||||0.4||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620366|NCT02320838|2977051|Other|||||||0.02||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620367|NCT02320838|2977052|Other|||||||0.8||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620368|NCT02320838|2977053|Other|||||||0.003||||||A priori threshold for statistical significance. p<0,05|t-test, 2 sided||||
1620369|NCT02320838|2977054|Other|||||||0.023||||||A priori threshold for statistical significance. p<0.05|Chi-squared||||
1620370|NCT02320838|2977055|Other|||||||0.003||||||A priori threshold for statistical significance. p<0.05|t-test, 2 sided||||
1620371|NCT02320838|2977056|Other|||||||0.001||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620372|NCT02320838|2977057|Other|||||||0.9||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620373|NCT02320838|2977058|Other|||||||0.04||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620374|NCT02320838|2977059|Other||||||<|0.001||||||A priori threshold for statistical significance. p<0.05|ANOVA||||
1620375|NCT02320721|2977075|Superiority or Other (legacy)|A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only if previous endpoint was statistically significant at 0.05 level.|Relative risk|1.01||||0.8415|2-Sided|95.0|0.89|1.153||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was done by Cochran-Mantel-Haenszel method with randomization strata (screening HbA1c [<8.0%; ≥8.0%], previous use of insulin [naive, pre-treated], use of sulfonylurea or meglitinides at screening [yes, no]), following multiple imputation procedure for missing data.|
1620376|NCT02320721|2977076|Non-Inferiority|Non-inferiority of HOE901-U300 vs Lantus was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for the difference between groups was <0.3%.|LS Mean Difference|0.02|Standard Error of the Mean|0.056|||2-Sided|95.0|-0.092|0.129||||||Analysis was performed using ANCOVA model including the fixed categorical effects of treatment group, randomization strata, as well as the continuous fixed covariates of baseline value and following multiple imputation procedure for missing data.|
1620377|NCT02320695|2977079|Non-Inferiority or Equivalence|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.34|Standard Error of the Mean|0.12||0.013|2-Sided|95.0|-0.63|-0.07|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.|||
1620378|NCT02320695|2977079|Non-Inferiority or Equivalence|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.37|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|-0.67|-0.16|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.|||
1620379|NCT02320695|2977079|Non-Inferiority or Equivalence|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.08|Standard Error of the Mean|0.12|<|0.522|2-Sided|95.0|-0.32|0.2|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.|||
1620380|NCT02320695|2977079|Non-Inferiority or Equivalence|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.29|Standard Error of the Mean|0.12|<|0.023|2-Sided|95.0|-0.54|-0.05|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.|||
1620381|NCT02320695|2977080|Non-Inferiority or Equivalence|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.31|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|-0.53|-0.12|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.|||
1620382|NCT02320695|2977080|Non-Inferiority or Equivalence|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.28|Standard Error of the Mean|0.12|<|0.002|2-Sided|95.0|-0.49|-0.1|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.|||
1620383|NCT02320695|2977080|Non-Inferiority or Equivalence|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.2|Standard Error of the Mean|0.12|<|0.101|2-Sided|95.0|-0.42|0.04|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.|||
1620384|NCT02320695|2977080|Non-Inferiority or Equivalence|"For the purpose of showing equivalent stinging of investigational product to saline, the hypothesis was set up as: Ho: μ1 - μ2 ≥ D vs HA: μ1 - μ2 < D where D was the non-inferiority margin. Equivalent stinging of investigational product to saline was claimed if the upper limit of the two-sided 95% confidence interval of (investigational product - saline) was less than 0.5."|Mean Difference (Net)|-0.12|Standard Error of the Mean|0.12|<|0.187|2-Sided|95.0|-0.33|0.05|||ANCOVA|Terms included treatment as factor, post tape-stripping score as covariate and subject as random effect to incorporate within-subject correlations.|||
1620385|NCT02320396|2977096|Superiority or Other||Odds Ratio (OR)|2.149|||<|0.001|2-Sided|95.0|1.408|3.28|||Regression, Logistic|||"Impression Rate as Assessed by Participant: Desloratadine 5 mg/Placebo Odds Ratio~Impression was evaluated using a logistic model with impression rate (percentage of assessments of “Better” + “Much better”) as a response variable and treatment and severity as factors. Odds ratio was estimated and tested. A point estimate of >1 indicated that desloratadine 5mg was more effective than placebo"|
1620386|NCT02320396|2977097|Superiority or Other||Odds Ratio (OR)|1.492||||0.071|2-Sided|95.0|0.966|2.303|||Regression, Logistic|||"Impression Rate as Assessed by Investigator: Desloratadine 5 mg/Placebo Odds Ratio~Impression was evaluated using a logistic model with impression rate (percentage of assessments of “Better” + “Much better”) as a response variable and treatment and severity as factors. Odds ratio was estimated and tested. A point estimate of >1 indicated that desloratadine 5mg was more effective than placebo."|
1620387|NCT02320396|2977098|Superiority or Other||Difference in LS Means|-0.17|||<|0.001|2-Sided|95.0|-0.26|-0.08|||cLDA model|||"Change from BL in Interference with Daily Activities During 2 Wks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Interference with Daily Activities estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo evaluated with the 95% confidence interval and P-value."|
1620388|NCT02320396|2977098|Superiority or Other||Difference in LS Means|-0.19|||<|0.001|2-Sided|95.0|-0.3|-0.09|||cLDA model|||"Change from BL to Week 2 in Interference with Daily Activities: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Interference with Daily Activities was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620389|NCT02320396|2977098|Superiority or Other||Difference in LS Means|-0.16|||<|0.001|2-Sided|95.0|-0.24|-0.07|||cLDA model|||"Change from BL to Week 1 in Interference with Daily Activities: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Interference with Daily Activities was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620390|NCT02320396|2977099|Superiority or Other||Difference in LS Means|-0.25|||<|0.001|2-Sided|95.0|-0.35|-0.15|||cLDA model|||The LS mean change from BL to post BL (average score of 2 weeks) in the worse of Pruritus or Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1-Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value|
1620391|NCT02320396|2977099|Superiority or Other||Difference in LS Means|-0.15|||<|0.001|2-Sided|95.0|-0.23|-0.07|||cLDA model|||"Change from BL in Watering Eyes During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620392|NCT02320396|2977099|Superiority or Other||Difference in LS Means|-0.25|||<|0.001|2-Sided|95.0|-0.35|-0.14|||cLDA model|||"Change from BL in Eye Pruritus During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620393|NCT02320396|2977100|Superiority or Other||Difference in LS Means|-0.24|||<|0.001|2-Sided|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620394|NCT02320396|2977100|Superiority or Other||Difference in LS Means|-0.13|||<|0.01|2-Sided|95.0|-0.24|-0.03|||cLDA model|||"Change from BL to Week 2 in Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620395|NCT02320396|2977100|Superiority or Other||Difference in LS Means|-0.25|||<|0.001|2-Sided|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Eye Pruritus: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620396|NCT02320396|2977101|Superiority or Other||Difference in LS Means|-0.25|||<|0.001|2-Sided|95.0|-0.35|-0.15|||cLDA model|||"Change from BL to Week 1 in Worse of Pruritus or Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in the worse symptom of Pruritus or Watering Eyes estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620397|NCT02320396|2977101|Superiority or Other||Difference in LS Means|-0.16|||<|0.001|2-Sided|95.0|-0.24|-0.08|||cLDA model|||"Change from BL to Week 1 in Watering Eyes: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Watering Eyes was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620398|NCT02320396|2977101|Superiority or Other||Difference in LS Means|-0.25|||<|0.001|2-Sided|95.0|-0.35|-0.15|||cLDA model|||"Change from BL to Week 1 in Eye Pruritus: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Eye Pruritus was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620399|NCT02320396|2977102|Superiority or Other||Difference in LS Means|-0.26|||<|0.001|2-Sided|95.0|-0.38|-0.15|||cLDA model|||"Change from BL in Nasal Itching During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value.~cLDA model"|
1620400|NCT02320396|2977102|Superiority or Other||Difference in LS Means|-0.09|||<|0.009|2-Sided|95.0|-0.16|-0.02|||cLDA model|||"Change from BL in Nasal Congestion During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620401|NCT02320396|2977102|Superiority or Other||Difference in LS Means|-0.23|||<|0.001|2-Sided|95.0|-0.33|-0.12|||cLDA model|||"Change from BL in Rhinorrhea During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620402|NCT02320396|2977102|Superiority or Other||Difference in LS Means|-0.25|||<|0.001|2-Sided|95.0|-0.35|-0.14|||cLDA model|||"Change from BL in Sneezing During 2 Weeks: Desloratadine vs. Placebo~The LS mean change from BL to post BL (average score of 2 weeks) in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score from Day 1 to Day 13) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620418|NCT02320149|2977117|Superiority||Least Squares Mean Difference|6.4||||0.2861|2-Sided|95.0|-5.3|18.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3|
1620450|NCT02319148|2977188|Superiority or Other||Ratio of adjusted geometric means|116.36|||||2-Sided|90.0|101.86|132.92|||||||
1620403|NCT02320396|2977103|Superiority or Other||Difference in LS Means|-0.26|||<|0.001|2-Sided|95.0|-0.4|-0.12|||cLDA model|||"Change from BL to Week 2 in Nasal Itching: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620404|NCT02320396|2977103|Superiority or Other||Difference in LS Means|-0.09|||<|0.037|2-Sided|95.0|-0.18|-0.01|||cLDA model|||"Change from BL to Week 2 in Nasal Congestion: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620405|NCT02320396|2977103|Superiority or Other||Difference in LS Means|-0.25|||<|0.001|2-Sided|95.0|-0.37|-0.12|||cLDA model|||"Change from BL to Week 2 in Rhinorrhea: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620406|NCT02320396|2977103|Superiority or Other||Difference in LS Means|-0.25|||<|0.001|2-Sided|95.0|-0.36|-0.13|||cLDA model|||"Change from BL to Week 2 in Sneezing: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620407|NCT02320396|2977104|Superiority or Other||Difference in LS Means|-0.27|||<|0.001|2-Sided|95.0|-0.38|-0.15|||cLDA model|||"Change from BL to Week 1 in Nasal Itching: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Nasal Itching was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620408|NCT02320396|2977104|Superiority or Other||Difference in LS Means|-0.09|||<|0.008|2-Sided|95.0|-0.16|-0.02|||cLDA model|||"Change from BL to Week 1 in Nasal Congestion: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Nasal Congestion was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620409|NCT02320396|2977104|Superiority or Other||Difference in LS Means|-0.21|||<|0.001|2-Sided|95.0|-0.32|-0.1|||cLDA model|||"Change from BL to Week 1 in Rhinorrhea: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Rhinorrhea was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620410|NCT02320396|2977104|Superiority or Other||Difference in LS Means|-0.25|||<|0.001|2-Sided|95.0|-0.35|-0.14|||cLDA model|||"Change from BL to Week 1 in Sneezing: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in Sneezing was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620411|NCT02320396|2977105|Superiority or Other||Difference in LS Means|-0.84|||<|0.001|2-Sided|95.0|-1.23|-0.46|||cLDA model|||"Change from BL in TNSS at Week 2: Desloratadine vs. Placebo~The LS mean change from BL to Week 2 post BL in TNSS was estimated using a cLDA model, where both BL and post- BL measurements (average score of 1 week prior to Week 2) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620412|NCT02320396|2977105|Superiority or Other||Difference in LS Means|-0.82|||<|0.001|2-Sided|95.0|-1.14|-0.5|||cLDA model|||"Change from BL in TNSS at Week 1: Desloratadine vs. Placebo~The LS mean change from BL to Week 1 post BL in TNSS was estimated using a cLDA model, where both BL and post-BL measurements (average score of 1 week prior to Week 1) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value."|
1620413|NCT02320396|2977108|Superiority or Other||Difference in Least Squares (LS) Means|-0.83|||<|0.001|2-Sided|95.0|-1.14|-0.51|||cLDA model|||The LS mean change from BL to post BL (average score of 2 weeks) in TNSS was estimated using a constrained longitudinal data analysis (cLDA) model, where both BL and post-BL measurements (average score of 2 weeks) were included in the response variable. The treatment difference in terms of LS mean change from BL between desloratadine 5 mg and placebo was evaluated with the 95% confidence interval and P-value.|
1620414|NCT02320149|2977113|Superiority||Least Squares Mean Difference|-0.8||||0.3806|2-Sided|95.0|-2.5|1.0||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3|
1620415|NCT02320149|2977114|Superiority||Least Squares Mean Difference|-2.0||||0.0371|2-Sided|95.0|-4.0|-0.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6|
1620416|NCT02320149|2977115|Superiority||Least Squares Mean Difference|-3.4||||0.001|2-Sided|95.0|-5.5|-1.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9|
1620417|NCT02320149|2977116|Superiority||Least Squares Mean Difference|-3.9||||0.0014|2-Sided|95.0|-6.3|-1.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 12|
1620419|NCT02320149|2977118|Superiority||Least Squares Mean Difference|3.0||||0.7377|2-Sided|95.0|-14.7|20.7||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6|
1620420|NCT02320149|2977119|Superiority||Least Squares Mean Difference|-2.8||||0.6969|2-Sided|95.0|-17.1|11.4||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9|
1620421|NCT02320149|2977120|Superiority||Least Squares Mean Difference|-4.3||||0.5786|2-Sided|95.0|-19.4|10.8||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12|
1620422|NCT02320149|2977121|Superiority||Least Squares Mean Difference|-2.1||||0.0005|2-Sided|95.0|-3.3|-0.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 3|
1620423|NCT02320149|2977122|Superiority||Least Squares Mean Difference|-4.1|||<|0.0001|2-Sided|95.0|-5.4|-2.9||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 6|
1620424|NCT02320149|2977123|Superiority||Least Squares Mean Difference|-3.9|||<|0.0001|2-Sided|95.0|-5.3|-2.5||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Change from Baseline to Week 9|
1620425|NCT02320149|2977124|Superiority||Least Squares Mean Difference|-7.2||||0.0003|2-Sided|95.0|-11.1|-3.3||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 3|
1620426|NCT02320149|2977125|Superiority||Least Squares Mean Difference|-13.3|||<|0.0001|2-Sided|95.0|-17.5|-9.1||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 6|
1620427|NCT02320149|2977126|Superiority||Least Squares Mean Difference|-12.5|||<|0.0001||95.0|-16.9|-8.0||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 9|
1620428|NCT02320149|2977127|Superiority||Least Squares Mean Difference|-16.7|||<|0.0001|2-Sided|95.0|-21.9|-11.6||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo|Percent Change from Baseline to Week 12|
1620429|NCT02320149|2977128|Superiority||Treatment Rate Difference|11.05|||<|0.0001|2-Sided|95.0|6.39|15.72||P-values were based on the test of general association between the response and treatment group using Cochran-Mantel-Haenszel test with pooled site as stratification factor.|Cochran-Mantel-Haenszel||sarecycline - placebo||
1620430|NCT02320149|2977129|Superiority||Least Squares Mean Difference|-5.2|||<|0.0001|2-Sided|95.0|-6.7|-3.6||Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|ANCOVA||sarecycline - placebo||
1620431|NCT02319668|2977153|Superiority or Other||Least square (LS) Mean difference|0.2||||0.2965|2-Sided|95.0|-0.18|0.58|||ANCOVA|ANCOVA with treatment as factor and baseline as covariate.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1620432|NCT02319525|2977161|Superiority or Other|||||||0.006|||||||Chi-squared|||The test of significance compared all the rows, i.e., all response options for the statement.|
1620433|NCT02319525|2977162|Superiority or Other||||||<|0.001|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the study about other patients"|
1620434|NCT02319525|2977162|Superiority or Other||||||<|0.001|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the evidence about medications"|
1620435|NCT02319525|2977162|Superiority or Other||||||<|0.003|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the medication options"|
1620436|NCT02319525|2977162|Superiority or Other||||||<|0.006|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the Risk factors"|
1620437|NCT02319525|2977162|Superiority or Other||||||<|0.006|||||||Chi-squared|||"statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the Impact of lupus nephritis"|
1620438|NCT02319525|2977163|Superiority or Other|||||||0.06|||||||t-test, 2 sided||||
1620439|NCT02319525|2977164|Superiority or Other|||||||0.504|||||||t-test, 2 sided||||
1620440|NCT02319525|2977165|Superiority or Other|||||||0.252|||||||Chi-squared|||We compared concordance between preferred and actual roles vs. no concordance between roles between decision aid and pamphlet.|
1620441|NCT02319525|2977166|Superiority or Other|||||||0.08||||||We compared informed choice vs. no informed choice made between the decision aid and the pamphlet groups.|Chi-squared||||
1620442|NCT02319525|2977167|Superiority or Other|||||||0.005|||||||t-test, 2 sided||||
1620443|NCT02319486|2977168|Superiority or Other||Probability of Event-Free Survival ，pEFS|0.32||||0.034|2-Sided|||||stage 2 vs stage 3|pEFS||over all pEFS||
1620444|NCT02319148|2977186|Superiority or Other||Ratio of adjusted geometric means|102.69|||||2-Sided|90.0|89.42|117.93|||||||
1620445|NCT02319148|2977186|Superiority or Other||Ratio of adjusted geometric means|106.97|||||2-Sided|90.0|93.1|122.91|||||||
1620446|NCT02319148|2977186|Superiority or Other||Ratio of adjusted geometric means|91.33|||||2-Sided|90.0|79.49|104.94|||||||
1620447|NCT02319148|2977187|Superiority or Other||Ratio of adjusted geometric means|101.71|||||2-Sided|90.0|88.68|116.66|||||||
1620448|NCT02319148|2977187|Superiority or Other||Ratio of adjusted geometric means|106.38|||||2-Sided|90.0|92.7|122.07|||||||
1620451|NCT02319148|2977188|Superiority or Other||Ratio of adjusted geometric means|92.54|||||2-Sided|90.0|80.96|105.77|||||||
1620452|NCT02319148|2977188|Superiority or Other||Ratio of adjusted geometric means|105.28|||||2-Sided|90.0|92.11|120.34|||||||
1620453|NCT02318992|2977213|Other|||||||0.041|||||||Chi-squared, Corrected||||
1620454|NCT02318992|2977214|Other|||||||0.157|||||||Chi-squared, Corrected||||
1620455|NCT02318797|2977228|Superiority|||||||0.9209|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)|
1620456|NCT02318797|2977228|Superiority|||||||0.4715|||||||Mixed Models Analysis|||Test for treatment by time interaction|
1620457|NCT02318797|2977229|Superiority|||||||0.0202|||||||Mixed Models Analysis|||Test for treatment by time interaction|
1620458|NCT02318797|2977230|Superiority||||||<|0.0001|||||||Mixed Models Analysis|||Test for treatment by time interaction|
1620459|NCT02318797|2977231|Superiority|||||||0.1772|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)|
1620460|NCT02318797|2977231|Superiority|||||||0.1653|||||||Mixed Models Analysis|||Test for treatment by time interaction|
1620461|NCT02318797|2977232|Superiority||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)|
1620462|NCT02318797|2977232|Superiority||||||<|0.0745|||||||Mixed Models Analysis|||Test for treatment by time interaction|
1620463|NCT02318797|2977233|Superiority|||||||0.0569|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)|
1620464|NCT02318797|2977233|Superiority|||||||0.1183|||||||Mixed Models Analysis|||Test for treatment by time interaction|
1620465|NCT02318797|2977234|Superiority|||||||0.0021|||||||Mixed Models Analysis|||Test for treatment by time interaction|
1620466|NCT02318797|2977235|Superiority|||||||0.0029|||||||Mixed Models Analysis|||Test for treatment by time interaction|
1620467|NCT02318797|2977236|Superiority|||||||0.002|||||||Mixed Models Analysis|||Test for treatment by time interaction|
1620468|NCT02318797|2977237|Superiority||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time (only calculated if treatment by time interaction non-significant)|
1620469|NCT02318797|2977237|Superiority||||||<|0.5566|||||||Mixed Models Analysis|||Treatment by time interaction test|
1620470|NCT02318797|2977238|Superiority|||||||0.0001|||||||Mixed Models Analysis|||Test for treatment by time interaction|
1620471|NCT02318797|2977239|Superiority|||||||0.0014|||||||Mixed Models Analysis|||Treatment by time interaction test|
1620472|NCT02318797|2977240|Superiority|||||||0.0058|||||||Mixed Models Analysis|||Treatment by time interaction test|
1620473|NCT02318797|2977241|Superiority|||||||0.0014|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)|
1620474|NCT02318797|2977241|Superiority|||||||0.4797|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction|
1620475|NCT02318797|2977241|Superiority||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)|
1620476|NCT02318797|2977241|Superiority||||||<|0.2179|||||||Mixed Models Analysis|||Treatment by time interaction test|
1620477|NCT02318797|2977242|Superiority|||||||0.1792|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)|
1620478|NCT02318797|2977242|Superiority|||||||0.05|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction|
1620479|NCT02318797|2977242|Superiority||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)|
1620480|NCT02318797|2977242|Superiority||||||<|0.4582|||||||Mixed Models Analysis|||Treatment by time interaction test|
1620481|NCT02318797|2977243|Superiority|||||||0.2656|||||||Mixed Models Analysis|||Test for gender by treatment interaction (only calculated if gender by treatment by time non-significant)|
1620482|NCT02318797|2977243|Superiority|||||||0.4068|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction|
1620483|NCT02318797|2977243|Superiority||||||<|0.0001|||||||Mixed Models Analysis|||Test for change over time from baseline (only conducted if treatment by time interaction test non-significant)|
1620484|NCT02318797|2977243|Superiority||||||<|0.4103|||||||Mixed Models Analysis|||Treatment by time interaction test|
1620485|NCT02318797|2977244|Superiority|||||||0.0019|||||||Mixed Models Analysis|||Test for gender by treatment by time interaction|
1620486|NCT02318797|2977244|Superiority||||||<|0.0001|||||||Mixed Models Analysis|||Treatment by time interaction test|
1620487|NCT02318693|2977245|Superiority or Other||LS Means Difference|0.0||||0.332|2-Sided|95.0|-0.1|0.0|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values < 50 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.|
1620488|NCT02318693|2977245|Superiority or Other||LS Means Difference|-0.6||||0.226|2-Sided|95.0|-1.5|0.4|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values < 60 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.|
1620489|NCT02318693|2977245|Superiority or Other||LS Means Difference|-1.1||||0.134|2-Sided|95.0|-2.5|0.3|||constrained longitudinal analysis model|||Comparison: Change in Baseline in Percentage of Hypoglycemic Values < 70 mg/dL. The comparison was conducted at the α=0.05 (2-sided) significance level.|
1620490|NCT02318693|2977246|Superiority or Other||LS Means Difference|15.7||||0.02|2-Sided|95.0|2.5|28.8|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.|
1620521|NCT02314923|2977569|Other||||||<|0.961|||||||ANOVA||||
1620522|NCT02314923|2977569|Other||||||<|0.169|||||||ANOVA||||
1620523|NCT02314923|2977569|Other||||||<|0.024|||||||ANOVA||||
1620524|NCT02314923|2977569|Other||||||<|0.191|||||||ANOVA||||
1620525|NCT02314923|2977569|Other||||||<|0.508|||||||ANOVA||||
1620491|NCT02318693|2977247|Superiority or Other||LS Means Difference|5.1||||0.509|2-Sided|95.0|-10.3|20.4|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Dinner. The comparison was conducted at the α=0.05 (2-sided) significance level.|
1620492|NCT02318693|2977247|Superiority or Other||LS Means Difference|-14.3||||0.043|2-Sided|95.0|-28.1|-0.5|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Lunch. The comparison was conducted at the α=0.05 (2-sided) significance level.|
1620493|NCT02318693|2977247|Superiority or Other||LS Means Difference|-12.8||||0.041|2-Sided|95.0|-25.1|-0.5|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||Comparison: Change from Baseline in Maximum Incremental Postprandial Glucose Levels at Breakfast. The comparison was conducted at the α=0.05 (2-sided) significance level.|
1620494|NCT02318693|2977248|Superiority or Other||LS Means Difference|-5.9||||0.029|2-Sided|95.0|-11.3|-0.6|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.|
1620495|NCT02318693|2977249|Superiority or Other||LS Means Difference|-8.8||||0.245|2-Sided|95.0|-23.8|6.2|||constrained longitudinal analysis model|Model included terms for treatment, time and time-by-treatment interaction with a constraint that mean baseline is the same for both treatment groups.||The comparison was conducted at the α=0.05 (2-sided) significance level.|
1620496|NCT02318667|2977258|Other|||||||0.1506|||||||t-test, 2 sided||||
1620497|NCT02318667|2977259|Other|||||||0.0074|||||||t-test, 2 sided||||
1620498|NCT02317809|2977300|Non-Inferiority or Equivalence|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Geometric least squares (LS) mean ratio|103.27|||||2-Sided|90.0|93.16|114.47|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.|
1620499|NCT02317809|2977301|Non-Inferiority or Equivalence|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|112.67|||||2-Sided|90.0|106.44|119.27|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.|
1620500|NCT02317809|2977302|Non-Inferiority or Equivalence|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.|Geometric least squares (LS) mean ratio|106.99|||||2-Sided|90.0|101.42|112.86|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.|
1620501|NCT02317809|2977303|Non-Inferiority or Equivalence|Bio-equivalence Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%|Geometric least squares (LS) mean ratio|114.45|||||2-Sided|90.0|110.87|118.15|||||Percentage of geometric LS mean ratio was presented.|Mixed model analysis was used.|
1620502|NCT02317016|2977352|Non-Inferiority or Equivalence|No effect on the PK of rosuvastatin after co-administration of AZD9291 was concluded if the 2-sided 90% CIs for the ratios of rosuvastatin AUC and Cmax were within the range of 70% to 143%.|Geometric LS Mean Ratio|134.63|||||2-Sided|90.0|115.41|157.07|||||AZD9291+ rosuvastatin / rosuvastatin alone (Day 32 versus Day 1).|Natural log-transformed AUC values were compared between treatments using a mixed effects ANOVA with treatment as a fixed effect and patient as a random effect. It was assumed the within-patient coefficient of variation for rosuvastatin in both AUC and Cmax was 41%. No change in the exposure for rosuvastatin when given with AZD9291 was also assumed.|
1620503|NCT02317016|2977353|Non-Inferiority or Equivalence|No effect on the PK of rosuvastatin after co-administration of AZD9291 was concluded if the 2-sided 90% confidence intervals (CIs) for the ratios of rosuvastatin AUC and Cmax were within the range of 70% to 143%.|Geometric least-squares (LS) mean ratio|171.92|||||2-Sided|90.0|145.94|202.53|||||AZD9291+ rosuvastatin / rosuvastatin alone (Day 32 versus Day 1).|Natural log-transformed Cmax values were compared between treatments using a mixed effects analysis of variance (ANOVA) with treatment as a fixed effect and patient as a random effect. It was assumed the within-patient coefficient of variation for rosuvastatin in both area under the plasma concentration-time curve (AUC) and Cmax was 41%. No change in the exposure for rosuvastatin when given with AZD9291 was also assumed.|
1620504|NCT02316470|2977446|Superiority or Other||||||<|0.0001||||||the p-value was <0.0001 at each time point (Day 14, 28, 35, 56, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.|
1620505|NCT02316470|2977447|Superiority or Other||||||<|0.0001||||||p-value was <0.0001 at each time point (Day 14, 28, 35, 56, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.|
1620506|NCT02316470|2977448|Superiority or Other||||||<|0.0001||||||p-value was <0.0001 at each time point (Day 14, 28, 35, 120, 210)|Fisher-Freeman-Halton Test|||statistical test was applied across all treatment groups at each of the listed time points.|
1620507|NCT02316470|2977449|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1620508|NCT02316470|2977449|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1620509|NCT02316470|2977449|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1620510|NCT02316470|2977449|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1620511|NCT02316470|2977449|Superiority or Other||||||<|0.0364|||||||Cochran-Mantel-Haenszel||||
1620512|NCT02316470|2977449|Superiority or Other||||||<|0.0261|||||||Cochran-Mantel-Haenszel||||
1620513|NCT02316470|2977449|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1620514|NCT02314923|2977569|Other||||||<|0.001|||||||ANOVA||||
1620515|NCT02314923|2977569|Other||||||<|0.37|||||||ANOVA||||
1620516|NCT02314923|2977569|Other||||||<|0.001|||||||ANOVA||||
1620517|NCT02314923|2977569|Other||||||<|0.007|||||||ANOVA||||
1620518|NCT02314923|2977569|Other||||||<|0.068|||||||ANOVA||||
1620519|NCT02314923|2977569|Other||||||<|0.001|||||||ANOVA||||
1620520|NCT02314923|2977569|Other||||||<|0.454|||||||ANOVA||||
1620556|NCT02314520|2977591|Superiority|||||||0.271||||||0.05 is the threshold for significance for this primary outcome.|Fisher Exact||||
1620557|NCT02314260|2977592|Superiority or Other||Mean Difference (Final Values)|5.5|Standard Error of the Mean|0.0578||0|2-Sided|95.0|0.0|10.0||P<0.05 is significant|t-test, 2 sided||at a cutoff value of 5.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.73 (73%).|The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.|
1620558|NCT02314260|2977593|Superiority or Other||Slope|4.5|Standard Error of the Mean|0.0318||0|2-Sided|95.0|0.0|10.0||P<0.05 is significant|t-test, 2 sided||at a cutoff value of 4.5, the sensitivity for failure to labour induction is 0.83 (83%), with a specificity of 0.87(87%).|The smallest cutoff value is the minimum observed test value minus 1, and the largest cutoff value is the maximum observed test value plus 1. All the other cutoff values are the averages of two consecutive ordered observed test values.|
1620559|NCT02314260|2977594|Superiority or Other||Mean Difference (Final Values)|0.806|Standard Error of the Mean|0.0578||0|2-Sided|95.0|0.693|0.919||Under the nonparametric assumption P value <0.05 is statistically significant|t-test, 2 sided||The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails. the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)|
1620560|NCT02314260|2977595|Superiority or Other||Mean Difference (Final Values)|0.917|Standard Error of the Mean|0.0318||0|2-Sided|95.0|0.854|0.979||Under the nonparametric assumption. P-value <0.05, means statistical significance|t-test, 2 sided||The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails. the Y-axis of the curve is sensitivity and the x- axis is (1-Specificity).|Null hypothesis: true area = 0.5 The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity)|
1620561|NCT02314143|2977616|Other||Odds Ratio (OR)|1.97||||0.4216|2-Sided|95.0|0.382|10.166|||Cochran-Mantel-Haenszel||The odds ratio for trametinib followed by combination therapy versus combination therapy has been presented.||
1620562|NCT02314143|2977616|Other||Odds Ratio (OR)|1.0||||1|2-Sided|95.0|0.224|4.459|||Cochran-Mantel-Haenszel||The odds ratio for dabrafenib followed by combination therapy versus combination therapy has been presented.||
1620563|NCT02314117|2977622|Superiority||Hazard Ratio (HR)|1.117|||||2-Sided|95.0|0.79|1.58|||||||
1620564|NCT02314117|2977624|Superiority||Hazard Ratio (HR)|1.013|||||2-Sided|95.0|0.77|1.332|||||||
1620565|NCT02314117|2977625|Superiority||Hazard Ratio (HR)|0.657|||||2-Sided|95.0|0.499|0.866|||||||
1620566|NCT02314117|2977626|Superiority||Hazard Ratio (HR)|0.699|||||2-Sided|95.0|0.569|0.859|||||||
1620567|NCT02314117|2977629|Superiority||Hazard Ratio (HR)|0.926|||||2-Sided|95.0|0.774|1.108|||||||
1620568|NCT02314117|2977630|Superiority||Hazard Ratio (HR)|0.962|||||2-Sided|95.0|0.801|1.156|||||||
1620569|NCT02314117|2977631|Superiority||Hazard Ratio (HR)|0.753|||||2-Sided|95.0|0.607|0.935|||||||
1620570|NCT02313909|2977651|Superiority||Hazard Ratio (HR)|2.01||||0.04409|2-Sided|95.0|1.0|4.02|||Log Rank|||Statistical analysis 1: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.|
1620571|NCT02313909|2977652|Superiority||Hazard Ratio (HR)|1.51||||0.00451|2-Sided|95.0|1.13|2.0|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.|
1620572|NCT02313909|2977653|Superiority||Hazard Ratio (HR)|2.34||||0.00443|2-Sided|95.0|1.28|4.29|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.|
1620573|NCT02313909|2977654|Superiority||Hazard Ratio (HR)|0.74||||0.34284|2-Sided|95.0|0.39|1.38|||Log Rank|||Statistical analysis 5: Myocardial infarction: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.|
1620574|NCT02313909|2977654|Superiority||Hazard Ratio (HR)|1.48||||0.14051|2-Sided|95.0|0.87|2.52|||Log Rank|||Statistical analysis 4:CV death: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.|
1620575|NCT02313909|2977654|Superiority||Hazard Ratio (HR)|1.42||||0.14822|2-Sided|95.0|0.88|2.28|||Log Rank|||Statistical analysis 3: Disabling stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.|
1620576|NCT02313909|2977654|Superiority||Hazard Ratio (HR)|1.03||||0.78738|2-Sided|95.0|0.83|1.29|||Log Rank|||Statistical analysis 2: Ischemic stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.|
1620577|NCT02313909|2977654|Superiority||Hazard Ratio (HR)|1.08||||0.4797|2-Sided|95.0|0.87|1.34|||Log Rank|||Statistical analysis 1: Stroke: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.|
1620578|NCT02313909|2977655|Superiority||Hazard Ratio (HR)|1.26||||0.22078|2-Sided|95.0|0.87|1.81|||Log Rank|||Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Confidence intervals were calculated, if at least 1 event in each treatment arm existed. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.|
1620579|NCT02313909|2977656|Superiority||Hazard Ratio (HR)|1.06||||0.56922|2-Sided|95.0|0.87|1.29|||Log Rank|||Statistical analysis: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Confidence intervals were calculated, if at least 1 event in each treatment arm existed. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.|
1620580|NCT02313909|2977657|Superiority||Hazard Ratio (HR)|2.72||||2e-05|2-Sided|95.0|1.68|4.39|||Log Rank|||Statistical analysis: ISTH major bleeding events: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.|
1620581|NCT02313909|2977658|Superiority||Hazard Ratio (HR)|1.07||||0.51884|2-Sided|95.0|0.87|1.33|||Log Rank|||Statistical analysis: Stroke + Systemic embolism: Risk reduction was estimated with the stratified Cox proportional hazards model. Hazard ratios (95% confidence interval) as compared to acetylsalicylic acid arm were reported. Rivaroxaban treatment was compared with the Acetylsalicylic acid control group using a stratified log-rank test. P-values (two-sided) as compared to acetylsalicylic acid arm were based on the log-rank test.|
1620582|NCT02313506|2977675|Superiority||Mean Difference (Net)|-11.0||||0.29|2-Sided|95.0|-31.1|9.1|||ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 3 compared T0-T1 in the immediate group against T0-T2 in the delayed group.|
1620583|NCT02313506|2977675|Superiority||Mean Difference (Net)|4.6||||0.71|2-Sided|95.0|-19.6|28.9|||ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 2 compared T0-T1 in the immediate group against T1-T2 in the delayed group.|
1620584|NCT02313506|2977675|Superiority||Mean Difference (Net)|-31.1||||0.02|2-Sided|95.0|-56.6|-5.7||No adjustment was made for multiple comparisons because Type II error is a greater concern than Type I error in feasibility studies.|ANCOVA|||ANCOVA was performed to evaluate the effect of the group type on the outcome measures after adjusting for blocking and baseline (T0). We assessed 3 planned contrasts of changes in outcome measures over time. Contrast 1 compared T0-T1 between the 2 groups to determine if the intervention was superior to the control.|
1620585|NCT02313454|2977676|Superiority||Mean Difference (Final Values)|-11.2|Standard Error of the Mean|15.7||0.004|2-Sided|95.0|-19.0|-3.4|||Paired t-test||Intranasal application relative to Extranasal application||
1620586|NCT02313454|2977677|Superiority||Mean Difference (Final Values)|-0.6|Standard Deviation|0.8||0.008|2-Sided|95.0|-1.0|-0.19|||Paired t-test||Intranasal Application relative to the Extranasal Application||
1620587|NCT02313233|2977678|Superiority or Other||||||<|0.05|||||||t-test, 1 sided||||
1620588|NCT02313233|2977679|Superiority or Other||||||<|0.05|||||||t-test, 1 sided||||
1620589|NCT02313233|2977682|Superiority or Other||||||<|0.05|||||||t-test, 1 sided||||
1620590|NCT02313233|2977683|Superiority or Other||||||<|0.05|||||||t-test, 1 sided||||
1620591|NCT02313155|2977704|Superiority or Other||Difference|-11.8|||||2-Sided|95.0|-30.048|6.547|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|B Strain|
1620592|NCT02313155|2977704|Superiority or Other||Difference|-15.5|||||2-Sided|95.0|-33.779|2.87|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|A/H3N2 Strain|
1620593|NCT02313155|2977704|Superiority or Other||Difference|-6.6|||||2-Sided|95.0|-24.858|11.592|||||Seroconversion rate difference between treatment groups was obtained by subtracting the value of TAK-850 I.M. from TAK-850 S.C.|A/H1N1 Strain|
1620594|NCT02312934|2977708|Other|||||||0.79||||||All pairwise comparisons were Sidak corrected for multiple comparisons at the p < 0.05 level.|Mixed Models Analysis|Degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = 0.72).||For the Secondary Aim (Specific Aim 2), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline CPT Scores (Visit 3, Visit 4, and Visit 5) as the dependent measure.|
1620595|NCT02312934|2977709|Other||||||=|0||||||All pairwise comparisons were Sidak corrected for multiple comparisons at the p < 0.05 level.|Mixed Models Analysis|Degrees of freedom were corrected using Greenhouse-Geisser estimates of sphericity (ε = 0.72).||For the Primary Aim (Specific Aim 1), a mixed-models repeated measures ANOVA was used to assess the interaction of treatment group (nicotine, placebo) with time (Visit), using change from baseline PCI FACT-Cog score (Visit 3, Visit 4, and Visit 5) as the dependent measure.|
1620596|NCT02312882|2977710|Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1620617|NCT02312713|2977722|Superiority||Mean Difference (Final Values)|7.02||||0.43|2-Sided|95.0|-10.31|24.35|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.|
1620618|NCT02312713|2977722|Superiority||Mean Difference (Final Values)|-6.82||||0.5|2-Sided|95.0|-26.55|12.91|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.|
1620597|NCT02312713|2977721|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.07||||0.93|2-Sided|95.0|-1.69|1.54|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Aerobic Exercise.|
1620598|NCT02312713|2977721|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.79||||0.27|2-Sided|95.0|-0.62|2.2|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Aerobic Exercise.|
1620599|NCT02312713|2977721|Superiority||Mean Difference (Final Values)|1.99||||0.05|2-Sided|95.0|0.01|3.97|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Aerobic Exercise.|
1620600|NCT02312713|2977721|Superiority||Mean Difference (Final Values)|1.89||||0.03|2-Sided|95.0|0.15|3.62|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Aerobic Exercise.|
1620601|NCT02312713|2977721|Superiority||Mean Difference (Final Values)|2.07||||0.04|2-Sided|95.0|0.13|4.0|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Aerobic Exercise.|
1620602|NCT02312713|2977721|Superiority||Mean Difference (Final Values)|1.09||||0.21|2-Sided|95.0|-0.61|2.8|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Aerobic Exercise.|
1620603|NCT02312713|2977721|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.45||||0.32|2-Sided|95.0|-0.44|1.34|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Stretching.|
1620604|NCT02312713|2977721|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.48||||0.33|2-Sided|95.0|-1.46|0.5|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Stretching.|
1620605|NCT02312713|2977721|Superiority||Mean Difference (Final Values)|2.07||||0|2-Sided|95.0|0.98|3.16|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Stretching.|
1620606|NCT02312713|2977721|Superiority||Mean Difference (Final Values)|1.37||||0.03|2-Sided|95.0|0.16|2.57|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Stretching.|
1620607|NCT02312713|2977721|Superiority||Mean Difference (Final Values)|1.62||||0|2-Sided|95.0|0.55|2.68|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Stretching.|
1620608|NCT02312713|2977721|Superiority||Mean Difference (Final Values)|1.85||||0|2-Sided|95.0|0.67|3.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Stretching.|
1620609|NCT02312713|2977721|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.14||||0.81|2-Sided|95.0|-1.03|1.31|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Strength.|
1620610|NCT02312713|2977721|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.51||||0.36|2-Sided|95.0|-1.6|0.58|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Strength.|
1620611|NCT02312713|2977721|Superiority||Mean Difference (Final Values)|1.35||||0.06|2-Sided|95.0|-0.08|2.78|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Strengthening Exercises.|
1620612|NCT02312713|2977721|Superiority||Mean Difference (Final Values)|0.85||||0.22|2-Sided|95.0|-0.49|2.19|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Strengthening Exercises.|
1620613|NCT02312713|2977721|Superiority||Mean Difference (Final Values)|1.21||||0.09|2-Sided|95.0|-0.18|2.6|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Strengthening Exercises.|
1620614|NCT02312713|2977721|Superiority||Mean Difference (Final Values)|1.36||||0.04|2-Sided|95.0|0.05|2.66|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Strengthening Exercises|
1620615|NCT02312713|2977722|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.09||||0.99|2-Sided|95.0|-14.41|14.23|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.|
1620616|NCT02312713|2977722|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-13.77||||0.09|2-Sided|95.0|-29.73|2.19|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.|
1620619|NCT02312713|2977722|Superiority||Mean Difference (Final Values)|7.11||||0.41|2-Sided|95.0|-9.69|23.91|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.|
1620620|NCT02312713|2977722|Superiority||Mean Difference (Final Values)|6.95||||0.48|2-Sided|95.0|-12.31|26.22|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.|
1620621|NCT02312713|2977723|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.22||||0.51|2-Sided|95.0|-0.86|0.43|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.|
1620622|NCT02312713|2977723|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.35||||0.32|2-Sided|95.0|-0.33|1.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.|
1620623|NCT02312713|2977723|Superiority||Mean Difference (Final Values)|-0.22||||0.58|2-Sided|95.0|-1.01|0.57|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.|
1620624|NCT02312713|2977723|Superiority||Mean Difference (Final Values)|-0.44||||0.31|2-Sided|95.0|-1.29|0.41|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.|
1620625|NCT02312713|2977723|Superiority||Mean Difference (Net)|0.0||||1|2-Sided|95.0|-0.77|0.77|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.|
1620626|NCT02312713|2977723|Superiority||Mean Difference (Final Values)|-0.79||||0.06|2-Sided|95.0|-1.62|0.04|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.|
1620627|NCT02312713|2977724|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.79||||0.33|2-Sided|95.0|-0.8|2.37|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.|
1620628|NCT02312713|2977724|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.48||||0.11|2-Sided|95.0|-0.33|3.29|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.|
1620629|NCT02312713|2977724|Superiority||Mean Difference (Final Values)|-1.65||||0.1|2-Sided|95.0|-3.58|0.29|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.|
1620630|NCT02312713|2977724|Superiority||Mean Difference (Final Values)|-0.99||||0.39|2-Sided|95.0|-3.24|1.27|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.|
1620631|NCT02312713|2977724|Superiority||Mean Difference (Final Values)|-2.43||||0.01|2-Sided|95.0|-4.31|-0.55|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.|
1620632|NCT02312713|2977724|Superiority||Mean Difference (Final Values)|-2.47||||0.03|2-Sided|95.0|-4.67|-0.26|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.|
1620633|NCT02312713|2977725|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.71||||0.06|2-Sided|95.0|-0.1|3.52|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.|
1620634|NCT02312713|2977725|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.19||||0.01|2-Sided|95.0|0.48|3.9|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.|
1620635|NCT02312713|2977725|Superiority||Mean Difference (Final Values)|0.65||||0.56|2-Sided|95.0|-1.56|2.86|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.|
1620636|NCT02312713|2977725|Superiority||Mean Difference (Final Values)|-0.39||||0.72|2-Sided|95.0|-2.52|1.74|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.|
1620637|NCT02312713|2977725|Superiority||Mean Difference (Final Values)|-1.06||||0.33|2-Sided|95.0|-3.22|1.09|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.|
1620638|NCT02312713|2977725|Superiority||Mean Difference (Final Values)|-2.58||||0.02|2-Sided|95.0|-4.67|-0.5|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.|
1620639|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|5.15||||0.02|2-Sided|95.0|0.92|9.37|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS QOL.|
1620640|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|3.29||||0.14|2-Sided|95.0|-1.08|7.67|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS QOL.|
1620641|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|7.74||||0|2-Sided|95.0|3.39|12.08|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS QOL.|
1620642|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|3.63||||0.11|2-Sided|95.0|-0.85|8.11|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS QOL.|
1620643|NCT02312713|2977726|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.59||||0.15|2-Sided|95.0|-0.96|6.13|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS QOL.|
1620644|NCT02312713|2977726|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.33||||0.86|2-Sided|95.0|-3.29|3.96|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS QOL.|
1620645|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|5.47||||0.05|2-Sided|95.0|-0.1|11.03|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS Sport/Rec.|
1620646|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|3.91||||0.14|2-Sided|95.0|-1.28|9.1|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS Sport/Rec.|
1620647|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|6.01||||0.04|2-Sided|95.0|0.29|11.74|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Sport/Rec.|
1620648|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|3.71||||0.17|2-Sided|95.0|-1.59|9.0|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Sport/Rec.|
1620649|NCT02312713|2977726|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.55||||0.82|2-Sided|95.0|-4.15|5.24|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS Sport/Rec.|
1620650|NCT02312713|2977726|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.21||||0.92|2-Sided|95.0|-4.47|4.06|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Sport/Rec.|
1620651|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|2.45||||0.22|2-Sided|95.0|-1.44|6.34|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for KOOS ADL.|
1620652|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|3.43||||0.07|2-Sided|95.0|-0.32|7.18|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for KOOS ADL.|
1620653|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|2.79||||0.17|2-Sided|95.0|-1.2|6.77|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 month for KOOS ADL.|
1620654|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|2.11||||0.28|2-Sided|95.0|-1.73|5.94|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 month for KOOS ADL.|
1620655|NCT02312713|2977726|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.33||||0.84|2-Sided|95.0|-2.93|3.59|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for KOOS ADL.|
1620656|NCT02312713|2977726|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-1.32||||0.4|2-Sided|95.0|-4.43|1.79|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS ADL.|
1620657|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|0.85||||0.7|2-Sided|95.0|-3.48|5.18|||Mixed Models Analysis|||This is the comparison between Standard Physical Therapy and Wait List Control at 12 months for KOOS Pain.|
1620658|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|2.37||||0.25|2-Sided|95.0|-1.67|6.4|||Mixed Models Analysis|||This is the comparison between Standard Physical Therapy and Wait List Control at 4 months for KOOS Pain.|
1620659|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|3.36||||0.14|2-Sided|95.0|-1.08|7.79|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for KOOS Pain.|
1620660|NCT02312713|2977726|Superiority||Mean Difference (Final Values)|3.94||||0.06|2-Sided|95.0|-0.19|8.06|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for KOOS Pain.|
1620661|NCT02312713|2977726|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|2.51||||0.17|2-Sided|95.0|-1.11|6.14|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months for KOOS Pain.|
1620662|NCT02312713|2977726|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|1.57||||0.36|2-Sided|95.0|-1.77|4.92|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for KOOS Pain.|
1620729|NCT02312687|2977738|Superiority||LS Mean|0.03|||||2-Sided|95.0|-0.01|0.08||||||Change at Week 144|
1620663|NCT02312713|2977727|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.0||||0.99|2-Sided|95.0|-0.77|0.78|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.|
1620664|NCT02312713|2977727|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.23||||0.49|2-Sided|95.0|-0.43|0.89|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.|
1620665|NCT02312713|2977727|Superiority||Mean Difference (Final Values)|-0.89||||0.06|2-Sided|95.0|-1.83|0.05|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.|
1620666|NCT02312713|2977727|Superiority||Mean Difference (Final Values)|-0.55||||0.19|2-Sided|95.0|-1.37|0.27|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.|
1620667|NCT02312713|2977727|Superiority||Mean Difference (Final Values)|-0.9||||0.05|2-Sided|95.0|-1.82|0.02|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.|
1620668|NCT02312713|2977727|Superiority||Mean Difference (Final Values)|-0.79||||0.05|2-Sided|95.0|-1.59|0.02|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.|
1620669|NCT02312713|2977728|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.72||||0.21|2-Sided|95.0|-1.85|0.41|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Timed Up and Go.|
1620670|NCT02312713|2977728|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.24||||0.63|2-Sided|95.0|-1.23|0.74|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Timed Up and Go.|
1620671|NCT02312713|2977728|Superiority||Mean Difference (Final Values)|-1.22||||0.08|2-Sided|95.0|-2.61|0.16|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Timed Up and Go.|
1620672|NCT02312713|2977728|Superiority||Mean Difference (Final Values)|-0.64||||0.3|2-Sided|95.0|-1.85|0.58|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Timed Up and Go.|
1620673|NCT02312713|2977728|Superiority||Mean Difference (Final Values)|-0.5||||0.46|2-Sided|95.0|-1.86|0.85|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Timed Up and Go.|
1620674|NCT02312713|2977728|Superiority||Mean Difference (Final Values)|-0.39||||0.52|2-Sided|95.0|-1.58|0.8|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Timed Up and Go.|
1620675|NCT02312713|2977729|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.74||||0.11|2-Sided|95.0|-0.17|1.64|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for 30 Second Chair Stand.|
1620676|NCT02312713|2977729|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.63||||0.23|2-Sided|95.0|-0.4|1.66|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for 30 Second Chair Stand.|
1620677|NCT02312713|2977729|Superiority||Mean Difference (Final Values)|0.24||||0.67|2-Sided|95.0|-0.87|1.35|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for 30 Second Chair Stand.|
1620678|NCT02312713|2977729|Superiority||Mean Difference (Final Values)|0.32||||0.62|2-Sided|95.0|-0.95|1.59|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for 30 Second Chair Stand.|
1620679|NCT02312713|2977729|Superiority||Mean Difference (Final Values)|-0.49||||0.37|2-Sided|95.0|-1.58|0.6|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for 30 Second Chair Stand.|
1620680|NCT02312713|2977729|Superiority||Mean Difference (Final Values)|-0.31||||0.63|2-Sided|95.0|-1.55|0.94|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for 30 Second Chair Stand.|
1620681|NCT02312713|2977730|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.0||||1|2-Sided|95.0|-0.78|0.77|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for Unilateral Stand Time.|
1620682|NCT02312713|2977730|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.61||||0.12|2-Sided|95.0|-0.16|1.38|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for Unilateral Stand Time.|
1620730|NCT02312687|2977738|Superiority||LS Mean|0.0|||||2-Sided|95.0|-0.02|0.03||||||Change at Week 120|
1620683|NCT02312713|2977730|Superiority||Mean Difference (Final Values)|0.04||||0.93|2-Sided|95.0|-0.91|1.0|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for Unilateral Stand Time|
1620684|NCT02312713|2977730|Superiority||Mean Difference (Final Values)|-0.02||||0.97|2-Sided|95.0|-0.97|0.93|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for Unilateral Stand Time.|
1620685|NCT02312713|2977730|Superiority||Mean Difference (Final Values)|0.04||||0.93|2-Sided|95.0|-0.89|0.98|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for Unilateral Stand Time.|
1620686|NCT02312713|2977730|Superiority||Mean Difference (Final Values)|-0.63||||0.19|2-Sided|95.0|-1.56|0.3|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for Unilateral Stand Time.|
1620687|NCT02312713|2977731|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.01||||1|2-Sided|95.0|-6.4|6.42|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 12 months for the 2 Minute Step Test.|
1620688|NCT02312713|2977731|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-2.86||||0.35|2-Sided|95.0|-8.94|3.21|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months for the 2 Minute Step Test.|
1620689|NCT02312713|2977731|Superiority||Mean Difference (Final Values)|1.13||||0.78|2-Sided|95.0|-6.74|8.99|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months for the 2 Minute Step Test.|
1620690|NCT02312713|2977731|Superiority||Mean Difference (Final Values)|4.88||||0.2|2-Sided|95.0|-2.56|12.33|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months for the 2 Minute Step Test.|
1620691|NCT02312713|2977731|Superiority||Mean Difference (Final Values)|1.12||||0.78|2-Sided|95.0|-6.59|8.82|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months for the 2 Minute Step Test.|
1620692|NCT02312713|2977731|Superiority||Mean Difference (Final Values)|7.75||||0.04|2-Sided|95.0|0.43|15.07|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months for the 2 Minute Step Test.|
1620693|NCT02312713|2977732|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|0.04||||0.83|2-Sided|95.0|-0.31|0.39|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.|
1620694|NCT02312713|2977732|Non-Inferiority|Since there were not sufficient data in prior literature to specific an a priori non-inferiority margin, for this and other secondary outcomes we based conclusions and discussions on magnitude of differences between the group, descriptively. This strategy was specified in the protocol.|Mean Difference (Final Values)|-0.5||||0|2-Sided|95.0|-0.84|-0.16|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.|
1620695|NCT02312713|2977732|Superiority||Mean Difference (Final Values)|0.27||||0.22|2-Sided|95.0|-0.16|0.7|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.|
1620696|NCT02312713|2977732|Superiority||Mean Difference (Final Values)|0.07||||0.75|2-Sided|95.0|-0.35|0.49|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.|
1620697|NCT02312713|2977732|Superiority||Mean Difference (Final Values)|0.23||||0.28|2-Sided|95.0|-0.19|0.65|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.|
1620698|NCT02312713|2977732|Superiority||Median Difference (Final Values)|0.56||||0.01|2-Sided|95.0|0.15|0.98|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.|
1620699|NCT02312713|2977733|Non-Inferiority|The IBET intervention will be non-inferior to the standard PT intervention, indicated by a mean WOMAC score less than 5 points higher than standard PT.|Mean Difference (Final Values)|-1.04||||0.51|2-Sided|95.0|-4.13|2.05|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet-Based Exercise Training at 12 months.|
1620700|NCT02312713|2977733|Non-Inferiority|The IBET intervention will be non-inferior to the standard PT intervention, indicated by a mean WOMAC score less than 5 points higher than standard PT.|Mean Difference (Final Values)|0.67||||0.65|2-Sided|95.0|-2.23|3.56|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Internet Based Exercise Training at 4 months.|
1620701|NCT02312713|2977733|Superiority||Mean Difference (Final Values)|-2.63||||0.17|2-Sided|95.0|-6.37|1.11|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 12 months.|
1620702|NCT02312713|2977733|Superiority||Mean Difference (Final Values)|-2.7||||0.14|2-Sided|95.0|-6.24|0.85|||Mixed Models Analysis|||This is the comparison between Internet Based Exercise Training and Wait List Control at 4 months.|
1620703|NCT02312713|2977733|Superiority||Mean Difference (Final Values)|-1.59||||0.39|2-Sided|95.0|-5.26|2.08|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 12 months.|
1620704|NCT02312713|2977733|Superiority||Mean Difference (Final Values)|-3.36||||0.06|2-Sided|95.0|-6.84|0.12|||Mixed Models Analysis|||This is the comparison between Physical Therapy and Wait List Control at 4 months.|
1620705|NCT02312687|2977734|Superiority||LS Mean|43.12||||0.2009|2-Sided|95.0|-22.96|109.2||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144|
1620731|NCT02312687|2977738|Superiority||LS Mean|-0.01|||||2-Sided|95.0|-0.04|0.02||||||Change at Week 96|
1620706|NCT02312687|2977734|Superiority||LS Mean|13.02||||0.1195|2-Sided|95.0|-3.37|29.4||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120|
1620707|NCT02312687|2977734|Superiority||LS Mean|27.02|||<|0.0001|2-Sided|95.0|13.81|40.22||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96|
1620708|NCT02312687|2977734|Superiority||LS Mean|28.3|||<|0.0002|2-Sided|95.0|13.24|43.37||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72|
1620709|NCT02312687|2977734|Superiority||LS Mean|44.4|||<|0.0001|2-Sided|95.0|30.34|58.47||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48|
1620710|NCT02312687|2977734|Superiority||LS Mean|72.45|||<|0.0001|2-Sided|95.0|39.21|105.7||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24|
1620711|NCT02312687|2977735|Superiority||LS Mean|-97.46||||0.08|2-Sided|95.0|-206.57|11.65||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144|
1620712|NCT02312687|2977735|Superiority||LS Mean|-53.41||||0.2907|2-Sided|95.0|-152.47|45.66||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120|
1620713|NCT02312687|2977735|Superiority||LS Mean|-68.62||||0.2772|2-Sided|95.0|-192.39|55.16||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96|
1620714|NCT02312687|2977735|Superiority||LS Mean|-61.96||||0.3288|2-Sided|95.0|-186.34|62.41||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72|
1620715|NCT02312687|2977735|Superiority||LS Mean|41.45||||0.4972|2-Sided|95.0|-78.23|161.13||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48|
1620716|NCT02312687|2977735|Superiority||LS Mean|343.38||||0.0113|2-Sided|95.0|77.66|609.11||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24|
1620717|NCT02312687|2977736|Superiority||LS Mean|-10.89|||<|0.0001|2-Sided|95.0|-14.77|-7.02||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144|
1620718|NCT02312687|2977736|Superiority||LS Mean|-10.01|||<|0.0001|2-Sided|95.0|-13.07|-6.95||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120|
1620719|NCT02312687|2977736|Superiority||LS Mean|-8.08|||<|0.0001|2-Sided|95.0|-9.86|-6.29||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96|
1620720|NCT02312687|2977736|Superiority||LS Mean|-7.45|||<|0.0001|2-Sided|95.0|-9.54|-5.36||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72|
1620721|NCT02312687|2977736|Superiority||LS Mean|-2.68|||<|0.233|2-Sided|95.0|-7.09|1.72||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48|
1620722|NCT02312687|2977736|Superiority||LS Mean|4.68|||<|0.1673|2-Sided|95.0|-1.96|11.32||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24|
1620723|NCT02312687|2977737|Superiority||LS Mean|-25.72|||<|0.0001|2-Sided|95.0|-36.89|-14.54||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144|
1620724|NCT02312687|2977737|Superiority||LS Mean|-18.77|||<|0.0094|2-Sided|95.0|-32.93|-4.6||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120|
1620725|NCT02312687|2977737|Superiority||LS Mean|-20.93|||<|0.0001|2-Sided|95.0|-27.92|-13.94||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96|
1620726|NCT02312687|2977737|Superiority||LS Mean|-22.28|||<|0.0001|2-Sided|95.0|-30.2|-14.35||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72|
1620727|NCT02312687|2977737|Superiority||LS Mean|-1.73|||<|0.764|2-Sided|95.0|-13.0|9.55||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48|
1620728|NCT02312687|2977737|Superiority||LS Mean|14.92|||<|0.0314|2-Sided|95.0|1.33|28.52||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24|
1620733|NCT02312687|2977738|Superiority||LS Mean|0.01|||||2-Sided|95.0|-0.01|0.04||||||Change at Week 48|
1620734|NCT02312687|2977738|Superiority||LS Mean|0.01|||||2-Sided|95.0|-0.01|0.03||||||Change at Week 24|
1620735|NCT02312687|2977739|Superiority||LS Mean|-96.06|||||2-Sided|95.0|-206.59|14.46||||||Change at Week 144|
1620736|NCT02312687|2977739|Superiority||LS Mean|-76.11|||||2-Sided|95.0|-237.29|85.08||||||Change at Week 120|
1620737|NCT02312687|2977739|Superiority||LS Mean|-41.74|||||2-Sided|95.0|-150.61|67.13||||||Change at Week 96|
1620738|NCT02312687|2977739|Superiority||LS Mean|-16.11|||||2-Sided|95.0|-110.96|78.73||||||Change at Week 72|
1620739|NCT02312687|2977739|Superiority||LS Mean|-70.79|||||2-Sided|95.0|-161.31|19.74||||||Change at Week 48|
1620740|NCT02312687|2977739|Superiority||LS Mean|-14.77|||||2-Sided|95.0|-87.62|58.08||||||Change at Week 24|
1620741|NCT02312687|2977740|Superiority||LS Mean|28.55|||||2-Sided|95.0|-11.12|68.22||||||Change at Week 144|
1620742|NCT02312687|2977740|Superiority||LS Mean|3.48|||||2-Sided|95.0|-32.53|39.49||||||Change at Week 120|
1620743|NCT02312687|2977740|Superiority||LS Mean|-16.65|||||2-Sided|95.0|-37.5|4.2||||||Change at Week 96|
1620744|NCT02312687|2977740|Superiority||LS Mean|11.1|||||2-Sided|95.0|-14.33|36.53||||||Change at Week 72|
1620745|NCT02312687|2977740|Superiority||LS Mean|15.15|||||2-Sided|95.0|-2.32|32.62||||||Change at Week 48|
1620746|NCT02312687|2977740|Superiority||LS Mean|22.89|||||2-Sided|95.0|-1.81|47.6||||||Change at Week 24|
1620747|NCT02312687|2977741|Superiority||LS Mean|-0.05|||||2-Sided|95.0|-0.16|0.06||||||Change at Week 144|
1620748|NCT02312687|2977741|Superiority||LS Mean|-0.01|||||2-Sided|95.0|-0.12|0.1||||||Change at Week 120|
1620749|NCT02312687|2977741|Superiority||LS Mean|-0.01|||||2-Sided|95.0|-0.09|0.06||||||Change at Week 96|
1620750|NCT02312687|2977741|Superiority||LS Mean|0.08|||||2-Sided|95.0|-0.01|0.16||||||Change at Week 72|
1620751|NCT02312687|2977741|Superiority||LS Mean|0.02|||||2-Sided|95.0|-0.07|0.1||||||Change at Week 48|
1620752|NCT02312687|2977741|Superiority||LS Mean|-0.01|||||2-Sided|95.0|-0.1|0.08||||||Change at Week 24|
1620753|NCT02312687|2977742|Superiority||LS Mean|-0.02|||||2-Sided|95.0|-0.05|0.01||||||Change at Week 144|
1620754|NCT02312687|2977742|Superiority||LS Mean|-0.01|||||2-Sided|95.0|-0.03|0.02||||||Change at Week 120|
1620755|NCT02312687|2977742|Superiority||LS Mean|-0.05|||||2-Sided|95.0|-0.07|-0.02||||||Change at Week 96|
1620756|NCT02312687|2977742|Superiority||LS Mean|-0.01|||||2-Sided|95.0|-0.04|0.01||||||Change at Week 72|
1620757|NCT02312687|2977742|Superiority||LS Mean|-0.01|||||2-Sided|95.0|-0.03|0.01||||||Change at Week 48|
1620758|NCT02312687|2977742|Superiority||LS Mean|-0.04|||||2-Sided|95.0|-0.07|-0.01||||||Change at Week 24|
1620759|NCT02312687|2977743|Superiority||LS Mean|0.02|||||2-Sided|95.0|-0.01|0.05||||||Change at Week 144|
1620760|NCT02312687|2977743|Superiority||LS Mean|0.01|||||2-Sided|95.0|-0.02|0.03||||||Change at Week 120|
1620761|NCT02312687|2977743|Superiority||LS Mean|0.05|||||2-Sided|95.0|0.02|0.07||||||Change at Week 96|
1620762|NCT02312687|2977743|Superiority||LS Mean|0.01|||||2-Sided|95.0|-0.01|0.04||||||Change at Week 72|
1620763|NCT02312687|2977743|Superiority||LS Mean|0.01|||||2-Sided|95.0|-0.01|0.03||||||Change at Week 48|
1620764|NCT02312687|2977743|Superiority||LS Mean|0.04|||||2-Sided|95.0|0.01|0.07||||||Change at Week 24|
1620765|NCT02312687|2977744|Superiority||LS Mean|0.47|||||2-Sided|95.0|0.32|0.62||||||Change at Week 144|
1620766|NCT02312687|2977744|Superiority||LS Mean|0.36|||||2-Sided|95.0|0.23|0.48||||||Change at Week 120|
1620767|NCT02312687|2977744|Superiority||LS Mean|0.44|||||2-Sided|95.0|0.27|0.6||||||Change at Week 96|
1620768|NCT02312687|2977744|Superiority||LS Mean|0.42|||||2-Sided|95.0|0.28|0.56||||||Change at Week 72|
1620769|NCT02312687|2977744|Superiority||LS Mean|0.47|||||2-Sided|95.0|0.37|0.56||||||Change at Week 48|
1620770|NCT02312687|2977744|Superiority||LS Mean|0.57|||||2-Sided|95.0|0.32|0.83||||||Change at Week 24|
1620771|NCT02312687|2977745|Superiority||LS Mean|-3.43||||0.2284|2-Sided|95.0|-9.0|2.15||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144|
1620772|NCT02312687|2977745|Superiority||LS Mean|-0.48||||0.8396|2-Sided|95.0|-5.11|4.16||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120|
1620773|NCT02312687|2977745|Superiority||LS Mean|0.31||||0.8796|2-Sided|95.0|-3.71|4.33||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96|
1620774|NCT02312687|2977745|Superiority||LS Mean|2.62||||0.2958|2-Sided|95.0|-2.29|7.53||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72|
1620775|NCT02312687|2977745|Superiority||LS Mean|2.7||||0.3092|2-Sided|95.0|-2.5|7.9||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48|
1620776|NCT02312687|2977745|Superiority||LS Mean|7.87||||0.0011|2-Sided|95.0|3.16|12.58||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24|
1620777|NCT02312687|2977746|Superiority||LS Mean|1298.41|||<|0.0001|2-Sided|95.0|1208.31|1388.51||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144|
1620778|NCT02312687|2977746|Superiority||LS Mean|1368.68|||<|0.0001|2-Sided|95.0|1327.4|1409.96||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120|
1621254|NCT02307682|2978235|Other|Treatment difference|Least squares mean difference|0.18|||||2-Sided|95.0|-1.6|1.9|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72|
1620779|NCT02312687|2977746|Superiority||LS Mean|1311.05|||<|0.0001|2-Sided|95.0|1238.3|1383.8||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96|
1620780|NCT02312687|2977746|Superiority||LS Mean|1298.49|||<|0.0001|2-Sided|95.0|1233.56|1363.43||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72|
1620781|NCT02312687|2977746|Superiority||LS Mean|1244.99|||<|0.0001|2-Sided|95.0|1166.1|1323.88||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48|
1620782|NCT02312687|2977746|Superiority||LS Mean|1277.84|||<|0.0001|2-Sided|95.0|1202.34|1353.34||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24|
1620783|NCT02312687|2977747|Superiority||LS Mean|235953.55|||<|0.0001|2-Sided|95.0|166110.59|305796.52||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144|
1620784|NCT02312687|2977747|Superiority||LS Mean|208270.02|||<|0.0001|2-Sided|95.0|167217.98|249322.06||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120|
1620785|NCT02312687|2977747|Superiority||LS Mean|221674.07|||<|0.0001|2-Sided|95.0|181313.34|262034.81||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96|
1620786|NCT02312687|2977747|Superiority||LS Mean|221481.03|||<|0.0001|2-Sided|95.0|179628.07|263333.98||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72|
1620787|NCT02312687|2977747|Superiority||LS Mean|202525.38|||<|0.0001|2-Sided|95.0|168364.92|236685.83||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48|
1620788|NCT02312687|2977747|Superiority||LS Mean|215493.38|||<|0.0001|2-Sided|95.0|194650.78|236335.97||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 24|
1620789|NCT02312687|2977748|Superiority||LS Mean|-28.33|||<|0.0001|2-Sided|95.0|-40.11|-16.56||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 144|
1620790|NCT02312687|2977748|Superiority||LS Mean|-22.39|||<|0.0001|2-Sided|95.0|-31.51|-13.26||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 120|
1620791|NCT02312687|2977748|Superiority||LS Mean|-25.28|||<|0.0001|2-Sided|95.0|-36.21|-14.35||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 96|
1620792|NCT02312687|2977748|Superiority||LS Mean|-18.12|||<|0.0001|2-Sided|95.0|-27.07|-9.17||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 72|
1620793|NCT02312687|2977748|Superiority||LS Mean|-11.17|||<|0.1334|2-Sided|95.0|-25.76|3.42||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 48|
1620794|NCT02312687|2977748|Superiority||LS Mean|-9.75|||<|0.1366|2-Sided|95.0|-22.59|3.09||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE estimate|||Change at Week 24|
1620795|NCT02312687|2977749|Superiority||LS Mean|0.59|||<|0.0001|2-Sided|95.0|0.43|0.76||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 144|
1620796|NCT02312687|2977749|Superiority||LS Mean|0.57|||<|0.0001|2-Sided|95.0|0.41|0.73||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 120|
1620797|NCT02312687|2977749|Superiority||LS Mean|0.47|||<|0.0001|2-Sided|95.0|0.31|0.63||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 96|
1620798|NCT02312687|2977749|Superiority||LS Mean|0.59|||<|0.0001|2-Sided|95.0|0.44|0.75||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 72|
1620799|NCT02312687|2977749|Superiority||LS Mean|0.68|||<|0.0001|2-Sided|95.0|0.57|0.79||The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|GEE|||Change at Week 48|
1620800|NCT02312687|2977749|Superiority||Least Squares (LS) Mean|0.68|||<|0.0001|2-Sided|95.0|0.48|0.88||The generalized estimation equation (GEE) model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure.|generalized estimation equation (GEE)|||Change at Week 24|
1620801|NCT02312206|2977771|Superiority||Hazard Ratio (HR)|0.835||||0.33|2-Sided|95.0|0.5799|1.2011|||Log Rank||||
1622375|NCT02295020|2979027|Superiority or Other|||||||0.735|||||||Wilcoxon (Mann-Whitney)||||
1620802|NCT02312154|2977772|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and –1, worse. Two independent investigators also individually assessed every patient’s improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.|
1620803|NCT02312154|2977773|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale, which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and –1, worse. Two independent investigators also individually assessed every patient’s improvement, and the values of the two scores were averaged for each patient. The Wilcoxon rank-sum test was performed to compare the pre-by-posttreatment changes in treated side.|
1620804|NCT02312154|2977774|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).|
1620805|NCT02312154|2977775|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).|
1620806|NCT02312154|2977776|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).|
1620807|NCT02312154|2977777|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The change in each of the biophysical parameters was calculated as the pretreatment value minus the posttreatment value for each visit, and these pre- vs posttreatment changes were used in the statistical analysis to minimize the intraindividual variation between the two cheeks. The Wilcoxon rank-sum test was performed to compare the week-by-week changes in parameters of the right and left cheeks (i.e., treated vs untreated).|
1620808|NCT02311972|2977781|Superiority|Infant 040||||||0.3947|||||||t-test, 2 sided||||
1620809|NCT02311972|2977781|Superiority|Infant 039|||||<|0.0001|||||||t-test, 2 sided||||
1620810|NCT02311972|2977781|Superiority|Infant 015|||||<|0.0001|||||||t-test, 2 sided||||
1620811|NCT02311972|2977781|Superiority|Infant 010|||||<|0.0001|||||||t-test, 2 sided||||
1620812|NCT02311972|2977781|Superiority|Infant 007|||||<|0.0001|||||||t-test, 2 sided||||
1620813|NCT02311972|2977782|Superiority|||||||0.4947|||||||t-test, 2 sided||||
1620814|NCT02311972|2977783|Superiority|||||||0.05|||||||t-test, 2 sided||||
1620815|NCT02311972|2977784|Superiority|||||||0.1089|||||||t-test, 2 sided||||
1620816|NCT02311972|2977785|Superiority|||||||0.05|||||||t-test, 2 sided||||
1620817|NCT02311972|2977786|Superiority|||||||0.236|||||||t-test, 2 sided||||
1620818|NCT02311972|2977787|Superiority|Mean axillary admission temperature||||||0.7294|||||||t-test, 2 sided||||
1620819|NCT02311907|2977795|Superiority or Other|||||||0.63|||||||Log Rank||||
1620820|NCT02311907|2977796|Superiority or Other|||||||0.21|||||||ANOVA|||Generalized linear models (repeated measures analysis of variance [ANOVA]) will be used to compare the CIPN between GSH and placebo arms.|
1620821|NCT02311881|2977812|Superiority or Other||LS mean difference|-0.15||||0.9352|2-Sided|95.0|-3.687|3.394|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: There is no significant difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 665 mg SR tablets and placebo.~H1: There is a significant difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 665 mg SR tablets and placebo."|
1620822|NCT02311881|2977812|Non-Inferiority or Equivalence|Paracetamol 2000mg BID is non-inferior to Paracetamol 1330mg TID if the upper bound of the 95% confidence Interval is less than 5.3.|LS mean difference|-2.36|||||2-Sided|95.0|-5.894|1.166|||||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: Difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 1000 mg SR tablet and Paracetamol 665 mg SR tablet is ≤ - 5.3 (inferiority).~H1: Difference in mean change from baseline through week 12 of WOMAC Pain between Paracetamol 1000 mg SR tablet and Paracetamol 665 mg SR tablet is > - 5.3 (noninferiority)."|
1620823|NCT02311881|2977812|Superiority or Other||LS mean difference|-2.51||||0.1626|2-Sided|95.0|-6.037|1.016|||ANCOVA||LS treatment means from mixed model analysis of covariance with treatment, target joint and center pools as fixed effects and baseline as a covariate.|"H0: There is no significant difference in mean change from baseline through week 12 of WOMAC Pain between twice daily Paracetamol 1000 mg SR tablets and placebo.~H1: There is a significant difference in mean change from baseline through week 12 of WOMAC Pain between twice daily Paracetamol 1000 mg SR tablets and placebo."|
1620824|NCT02311478|2977814|Equivalence|α of 0.05 or lower.|Mean Difference (Final Values)|0.93|||<|0.05|2-Sided|95.0|0.36|1.5|||t-test, 2 sided|||The estimation parameter compares the 90 days following to the 90 days prior.|
1620852|NCT02310763|2977854|Superiority||Mean Difference (Net)|2.0||||0.3597|2-Sided|95.0|-2.4|6.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620853|NCT02310763|2977855|Superiority||Mean Difference (Net)|2.9||||0.0926|2-Sided|95.0|-0.5|6.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1622376|NCT02295020|2979028|Superiority or Other|||||||0.86|||||||Wilcoxon (Mann-Whitney)||||
1620825|NCT02311478|2977814|Other|Given that this is a observational cohort design we do not use either non-inferiority or equivalence analysis. Using ANOVA we test for differences in the number of days per month of bleeding between the 90 days pre-insertion, the 90 days following insertion, and 91-180 days following insertion.|Mean Difference (Net)|1.77|Standard Error of the Mean|0.28|<|0.05|2-Sided|95.0|1.2|2.3||The p-value is not adjusted for multiple comparisons.|ANOVA|df=2||The null hypothesis is that there is no difference between the number of days of bleeding per month at baseline and the days of bleeding per month during 90 days after insertion, and months or 91-180 days following insertion.|
1620826|NCT02310763|2977843|Superiority||Mean Difference (Net)|1.98||||0.2414|2-Sided|95.0|-1.3513|5.3112||The significance level is 0.05|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49|
1620827|NCT02310763|2977843|Superiority||Mean Difference (Net)|1.755||||0.1866|2-Sided|95.0|-0.8621|4.3729||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33|
1620828|NCT02310763|2977843|Superiority||Mean Difference (Net)|0.761||||0.4921|2-Sided|95.0|-1.4272|2.9491||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17|
1620829|NCT02310763|2977844|Superiority||Mean Difference (Net)|2.864||||0.2035|2-Sided|95.0|-1.5718|7.2994||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49|
1620830|NCT02310763|2977844|Superiority||Mean Difference (Net)|2.11||||0.2102|2-Sided|95.0|-1.2078|5.4279||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33|
1620831|NCT02310763|2977844|Superiority||Mean Difference (Net)|2.189||||0.1323|2-Sided|95.0|-0.6721|5.0506||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17|
1620832|NCT02310763|2977848|Superiority||Mean Difference (Net)|3.9||||0.94|2-Sided|95.0|-100.7|108.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620833|NCT02310763|2977848|Superiority||Mean Difference (Net)|-15.8||||0.4634|2-Sided|95.0|-58.9|27.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <=8 seconds|
1620834|NCT02310763|2977848|Superiority||Mean Difference (Net)|7.0||||0.719|2-Sided|95.0|-32.1|46.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620835|NCT02310763|2977849|Superiority||Mean Difference (Net)|16.3||||0.7152|2-Sided|95.0|-73.4|106.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620836|NCT02310763|2977849|Superiority||Mean Difference (Net)|7.3||||0.6018|2-Sided|95.0|-20.6|35.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <=8 seconds|
1620837|NCT02310763|2977849|Superiority||Mean Difference (Net)|-3.7||||0.8117|2-Sided|95.0|-34.8|27.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620838|NCT02310763|2977850|Superiority||Mean Difference (Net)|13.1||||0.6896|2-Sided|95.0|-53.4|79.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620839|NCT02310763|2977850|Superiority||Mean Difference (Net)|-1.3||||0.9053|2-Sided|95.0|-23.9|21.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <=8 seconds|
1620840|NCT02310763|2977850|Superiority||Mean Difference (Net)|-5.8||||0.7483|2-Sided|95.0|-42.4|30.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620841|NCT02310763|2977851|Superiority||Mean Difference (Net)|-0.9||||0.6746|2-Sided|95.0|-5.5|3.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620842|NCT02310763|2977851|Superiority||Mean Difference (Net)|-0.1||||0.8629|2-Sided|95.0|-1.8|1.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <= 8 seconds|
1620843|NCT02310763|2977851|Superiority||Mean Difference (Net)|0.0||||0.9582|2-Sided|95.0|-1.5|1.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620844|NCT02310763|2977852|Superiority||Mean Difference (Net)|-1.0||||0.6736|2-Sided|95.0|-5.8|3.9||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620845|NCT02310763|2977852|Superiority||Mean Difference (Net)|-0.3||||0.6919|2-Sided|95.0|-1.9|1.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <=8 seconds|
1620846|NCT02310763|2977852|Superiority||Mean Difference (Net)|6.5||||0.097|2-Sided|95.0|-1.2|14.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620847|NCT02310763|2977853|Superiority||Mean Difference (Net)|-0.9||||0.6764|2-Sided|95.0|-5.4|3.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620848|NCT02310763|2977853|Superiority||Mean Difference (Net)|-1.2||||0.14|2-Sided|95.0|-2.9|0.4||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <= 8 seconds|
1620849|NCT02310763|2977853|Superiority||Mean Difference (Net)|1.2||||0.3345|2-Sided|95.0|-1.3|3.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620850|NCT02310763|2977854|Superiority||Mean Difference (Net)|4.0||||0.032|2-Sided|95.0|0.4|7.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620851|NCT02310763|2977854|Superiority||Mean Difference (Net)|0.5||||0.7345|2-Sided|95.0|-2.3|3.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <=8 seconds|
1620854|NCT02310763|2977855|Superiority||Mean Difference (Net)|1.6||||0.2027|2-Sided|95.0|-0.9|4.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <= 8 seconds|
1620855|NCT02310763|2977855|Superiority||Mean Difference (Net)|3.5||||0.0554|2-Sided|95.0|-0.1|7.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620856|NCT02310763|2977856|Superiority||Mean Difference (Net)|1.3||||0.2298|2-Sided|95.0|-0.9|3.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620857|NCT02310763|2977856|Superiority||Mean Difference (Net)|1.2||||0.2107|2-Sided|95.0|-0.7|3.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <=8 seconds|
1620858|NCT02310763|2977856|Superiority||Mean Difference (Net)|-0.3||||0.8925|2-Sided|95.0|-4.5|3.9||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620859|NCT02310763|2977857|Superiority||Mean Difference (Net)|0.1039||||0.3739|2-Sided|95.0|-0.1386|0.3463||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620860|NCT02310763|2977857|Superiority||Mean Difference (Net)|-0.0359||||0.4603|2-Sided|95.0|-0.1326|0.0608||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <= 8 seconds|
1620861|NCT02310763|2977857|Superiority||Mean Difference (Net)|-0.1013||||0.2101|2-Sided|95.0|-0.2622|0.0597||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620862|NCT02310763|2977858|Superiority||Mean Difference (Net)|0.0562||||0.6645|2-Sided|95.0|-0.2187|0.3312||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620863|NCT02310763|2977858|Superiority||Mean Difference (Net)|-0.0117||||0.8485|2-Sided|95.0|-0.1339|0.1105||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <= 8 seconds|
1620864|NCT02310763|2977858|Superiority||Mean Difference (Net)|-0.0934||||0.2294|2-Sided|95.0|-0.2481|0.0613||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620865|NCT02310763|2977859|Superiority||Mean Difference (Net)|0.0889||||0.3746|2-Sided|95.0|-0.1219|0.2996||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620866|NCT02310763|2977859|Superiority||Mean Difference (Net)|-0.0132||||0.7709|2-Sided|95.0|-0.1036|0.0772||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <=8 seconds|
1620867|NCT02310763|2977859|Superiority||Mean Difference (Net)|0.0159||||0.8229|2-Sided|95.0|-0.127|0.1588||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620868|NCT02310763|2977860|Superiority||Mean Difference (Net)|-11.2881||||0.2947|2-Sided|95.0|-32.8328|10.2566||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620869|NCT02310763|2977860|Superiority||Mean Difference (Net)|0.0944||||0.9503|2-Sided|95.0|-3.0798|3.2686||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <=8 seconds|
1620870|NCT02310763|2977860|Superiority||Mean Difference (Net)|-0.5582||||0.1163||95.0|-1.2615|0.1451||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620871|NCT02310763|2977861|Superiority||Mean Difference (Net)|8.2893||||0.3562|2-Sided|95.0|-9.6409|26.2194||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620872|NCT02310763|2977861|Superiority||Mean Difference (Net)|0.3457||||0.7648|2-Sided|95.0|-1.9614|2.6528||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <=8 seconds|
1620873|NCT02310763|2977861|Superiority||Mean Difference (Net)|-0.3289||||0.1353|2-Sided|95.0|-0.7649|0.1072||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620874|NCT02310763|2977862|Superiority||Mean Difference (Net)|-2.6439||||0.6469|2-Sided|95.0|-14.4292|9.1414||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>8 seconds|
1620875|NCT02310763|2977862|Superiority||Mean Difference (Net)|0.2114||||0.6893|2-Sided|95.0|-0.8472|1.27||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC>=3.5 and <= 8 seconds|
1620876|NCT02310763|2977862|Superiority||Mean Difference (Net)|-0.0692||||0.7033|2-Sided|95.0|-0.4345|0.2961||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Baseline 4SC<3.5 seconds|
1620877|NCT02310763|2977863|Superiority|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-66.3||||0.0267|2-Sided|95.0|-124.5|-8.1|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.||
1620878|NCT02310763|2977864|Equivalence|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-31.6||||0.1669|2-Sided|95.0|-76.9|13.6|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.||
1620879|NCT02310763|2977865|Superiority|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-3.9||||0.0146|2-Sided|95.0|-7.0|-0.8|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.||
1620880|NCT02310763|2977866|Equivalence|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|-2.9||||0.0483|2-Sided|95.0|-5.7|0.0|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.||
1620881|NCT02310763|2977867|Superiority|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.0506||||0.3643|2-Sided|95.0|-0.0594|0.1607|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.||
1620882|NCT02310763|2977868|Equivalence|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.0097||||0.807|2-Sided|95.0|-0.0692|0.0887|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.||
1620883|NCT02310763|2977869|Superiority|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.819||||0.4748|2-Sided|95.0|-1.4514|3.0895|||Mixed Models Analysis||Mean difference was calculated by Sequence 1 minus natural history control group.||
1620884|NCT02310763|2977870|Equivalence|The comparator was the natural history control group. The significance level is 0.05.|Mean Difference (Net)|0.211||||0.8908|2-Sided|95.0|-2.8353|3.2573|||Mixed Models Analysis||Mean difference was calculated by Sequence 3 minus natural history control group.||
1620885|NCT02310763|2977871|Superiority||Mean Difference (Net)|-0.439||||0.2328|2-Sided|95.0|-1.165|0.286||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 49|
1620886|NCT02310763|2977871|Superiority||Mean Difference (Net)|-0.757||||0.0086|2-Sided|95.0|-1.318|-0.196||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 33|
1620887|NCT02310763|2977871|Superiority||Mean Difference (Net)|-0.236||||0.3279|2-Sided|95.0|-0.711|0.239||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right shoulder abduction, Week 17|
1620888|NCT02310763|2977871|Superiority||Mean Difference (Net)|-0.023||||0.934|2-Sided|95.0|-0.566|0.521||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 49|
1620889|NCT02310763|2977871|Superiority||Mean Difference (Net)|-0.154||||0.5495|2-Sided|95.0|-0.663|0.355||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 33|
1620890|NCT02310763|2977871|Superiority||Mean Difference (Net)|-0.044||||0.8569|2-Sided|95.0|-0.525|0.437||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left shoulder abduction, Week 17|
1620891|NCT02310763|2977872|Superiority||Mean Difference (Net)|-0.149||||0.732|2-Sided|95.0|-1.008|0.71||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 49|
1620892|NCT02310763|2977872|Superiority||Mean Difference (Net)|-0.467||||0.2646|2-Sided|95.0|-1.294|0.359||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 33|
1620893|NCT02310763|2977872|Superiority||Mean Difference (Net)|-0.236||||0.4975|2-Sided|95.0|-0.924|0.451||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right knee extension, Week 17|
1620894|NCT02310763|2977872|Superiority||Mean Difference (Net)|0.113||||0.7815|2-Sided|95.0|-0.693|0.919||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 49|
1620895|NCT02310763|2977872|Superiority||Mean Difference (Net)|-0.322||||0.4127|2-Sided|95.0|-1.098|0.454||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 33|
1620896|NCT02310763|2977872|Superiority||Mean Difference (Net)|-0.107||||0.7676|2-Sided|95.0|-0.825|0.61||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left knee extension, Week 17|
1620897|NCT02310763|2977873|Superiority||Mean Difference (Net)|-0.322||||0.4019|2-Sided|95.0|-1.079|0.436||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 49|
1620898|NCT02310763|2977873|Superiority||Mean Difference (Net)|-0.336||||0.3739|2-Sided|95.0|-1.082|0.41||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 33|
1620899|NCT02310763|2977873|Superiority||Mean Difference (Net)|-0.689||||0.0526|2-Sided|95.0|-1.386|0.008||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right hip abduction, Week 17|
1620900|NCT02310763|2977873|Superiority||Mean Difference (Net)|-0.378||||0.3196|2-Sided|95.0|-1.128|0.371||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 49|
1620901|NCT02310763|2977873|Superiority||Mean Difference (Net)|0.046||||0.8967|2-Sided|95.0|-0.654|0.746||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 33|
1620902|NCT02310763|2977873|Superiority||Mean Difference (Net)|-0.586||||0.1078|2-Sided|95.0|-1.303|0.13||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left hip abduction, Week 17|
1620903|NCT02310763|2977874|Superiority||Mean Difference (Net)|-0.189||||0.3783|2-Sided|95.0|-0.612|0.234||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 49|
1620904|NCT02310763|2977874|Superiority||Mean Difference (Net)|-0.361||||0.1695|2-Sided|95.0|-0.877|0.156||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 33|
1620905|NCT02310763|2977874|Superiority||Mean Difference (Net)|-0.083||||0.7335|2-Sided|95.0|-0.564|0.399||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow flexion, Week 17|
1620906|NCT02310763|2977874|Superiority||Mean Difference (Net)|-0.161||||0.4665|2-Sided|95.0|-0.598|0.276||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 49|
1620907|NCT02310763|2977874|Superiority||Mean Difference (Net)|-0.303||||0.2669|2-Sided|95.0|-0.841|0.235||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 33|
1620908|NCT02310763|2977874|Superiority||Mean Difference (Net)|-0.156||||0.5557|2-Sided|95.0|-0.679|0.367||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow flexion, Week 17|
1620909|NCT02310763|2977875|Superiority||Mean Difference (Net)|-0.166||||0.4362|2-Sided|95.0|-0.587|0.255||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 49|
1620910|NCT02310763|2977875|Superiority||Mean Difference (Net)|-0.439||||0.0469|2-Sided|95.0|-0.872|-0.006||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 33|
1620911|NCT02310763|2977875|Superiority||Mean Difference (Net)|-0.022||||0.9274|2-Sided|95.0|-0.489|0.446||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right elbow extension, Week 17|
1620912|NCT02310763|2977875|Superiority||Mean Difference (Net)|-0.126||||0.5767|2-Sided|95.0|-0.573|0.321||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 49|
1620913|NCT02310763|2977875|Superiority||Mean Difference (Net)|-0.163||||0.4334|2-Sided|95.0|-0.574|0.248||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 33|
1620914|NCT02310763|2977875|Superiority||Mean Difference (Net)|0.115||||0.5726|2-Sided|95.0|-0.287|0.517||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left elbow extension, Week 17|
1620915|NCT02310763|2977876|Superiority||Mean Difference (Net)|-1.5||||0.916|2-Sided|95.0|-30.0|27.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49|
1620916|NCT02310763|2977876|Superiority||Mean Difference (Net)|8.9||||0.4008|2-Sided|95.0|-12.0|29.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33|
1620917|NCT02310763|2977876|Superiority||Mean Difference (Net)|1.8||||0.8499|2-Sided|95.0|-16.7|20.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17|
1620918|NCT02310763|2977877|Superiority||Mean Difference (Net)|0.0||||0.9391|2-Sided|95.0|-1.3|1.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49|
1620919|NCT02310763|2977877|Superiority||Mean Difference (Net)|1.7||||0.2065|2-Sided|95.0|-1.0|4.4||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33|
1620920|NCT02310763|2977877|Superiority||Mean Difference (Net)|-0.3||||0.6049|2-Sided|95.0|-1.7|1.0||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17|
1620921|NCT02310763|2977878|Superiority||Mean Difference (Net)|0.0||||0.9927|2-Sided|95.0|-3.3|3.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 49|
1620922|NCT02310763|2977878|Superiority||Mean Difference (Net)|2.9||||0.0385|2-Sided|95.0|0.2|5.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 33|
1620923|NCT02310763|2977878|Superiority||Mean Difference (Net)|0.8||||0.5995|2-Sided|95.0|-2.1|3.6||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Right ankle, Week 17|
1620924|NCT02310763|2977878|Superiority||Mean Difference (Net)|-1.5||||0.2939|2-Sided|95.0|-4.3|1.3||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 49|
1620925|NCT02310763|2977878|Superiority||Mean Difference (Net)|0.2||||0.8893|2-Sided|95.0|-2.4|2.7||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 33|
1620926|NCT02310763|2977878|Superiority||Mean Difference (Net)|-0.4||||0.7337|2-Sided|95.0|-2.9|2.1||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Left ankle, Week 17|
1620927|NCT02310763|2977879|Superiority|Week 49|Mean Difference (Net)|1.6||||0.1268|2-Sided|95.0|-0.5|3.8||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.||
1620928|NCT02310763|2977879|Superiority||Mean Difference (Net)|2.5||||0.0061|2-Sided|95.0|0.7|4.2||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33|
1620929|NCT02310763|2977879|Superiority||Mean Difference (Net)|0.8||||0.3522|2-Sided|95.0|-0.9|2.5||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17|
1620930|NCT02310763|2977880|Superiority||Mean Difference (Net)|-0.042||||0.3041|2-Sided|95.0|-0.1227|0.0386||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49|
1620931|NCT02310763|2977880|Superiority||Mean Difference (Net)|-0.0259||||0.5464|2-Sided|95.0|-0.1107|0.0589||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33|
1620932|NCT02310763|2977880|Superiority||Mean Difference (Net)|0.0||||0.9993|2-Sided|95.0|-0.0693|0.0693||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17|
1620933|NCT02310763|2977881|Superiority||Mean Difference (Net)|0.2712||||0.9423|2-Sided|95.0|-7.3799|7.9223||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 49|
1620934|NCT02310763|2977881|Superiority||Mean Difference (Net)|0.5837||||0.7642|2-Sided|95.0|-3.2978|4.4652||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 33|
1620935|NCT02310763|2977881|Superiority||Mean Difference (Net)|-0.0845||||0.9191|2-Sided|95.0|-1.7354|1.5663||The significance level is 0.05.|Mixed Models Analysis||Mean difference was calculated by domagrozumab minus placebo.|Week 17|
1620936|NCT02310763|2977885|Superiority||Mean Difference (Net)|1.293|Standard Error of the Mean|1.022||0.2088|2-Sided|95.0|-0.7343|3.32||The significance level is 0.05.|ANCOVA||Least square mean difference was calculated by placebo minus domagrozumab.||
1620937|NCT02310646|2977961|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank Test|Wilcoxon signed rank test comparing within subject difference to latest topical treatment||Subjects in the analysis are 118. All subjects received both study treatments. Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison gel versus latest topical treatment.|
1620938|NCT02310646|2977961|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank Test|Wilcoxon signed rank test comparing within subject difference to latest topical treatment||Subjects in the analysis are 118. All subjects received both study treatments. Statistical analysis for total TPUQ score (summary score item 1-25): superiority comparison foam versus latest topical treatment.|
1620939|NCT02310646|2977962|Superiority or Other|||||||0.007||||||"The total TPUQ score for the gel and the foam (mean score 29.9 vs. mean score 26.8; p=0.007).~Threshold for statistical significance: p<0.05."|Wilcoxon Rank Sum Test|Wilcoxon rank sum test comparing the period difference (within subject difference between study treatments) between both treatment sequences.||Subjects in the analysis are 212 - full analysis set. All subjects received both study treatments. Total TPUQ score (summary score item 1-25) superiority comparison gel versus foam.|
1620940|NCT02310646|2977963|Superiority or Other|||||||0.2||||||Treatment sequence effect: p=0.30; onset phenotype (≤40 years of age, >40 years of age) effect: p=0.20; threshold for statistical significance: p<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and onset phenotype (≤40 years of age, >40 years of age) as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: onset phenotype (≤40 years of age, >40 years of age)."|
1620941|NCT02310646|2977963|Superiority or Other|||||||0.41||||||Treatment sequence effect: p=0.34; skin thickness phenotype (≤0.75 mm, >0.75 mm) effect: p=0.41; threshold for statistical significance: p<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and skin thickness phenotype as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: skin thickness phenotype (≤0.75 mm, >0.75 mm)."|
1620942|NCT02310646|2977963|Superiority or Other|||||||0.25||||||Treatment sequence effect: p=0.32; plaque size (≤3 mm diameter, >3 mm diameter): p=0.25; threshold for statistical significance: p<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and plaque size as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: plaque size (≤3 mm diameter, >3 mm diameter)."|
1620943|NCT02310646|2977963|Superiority or Other|||||||0.55||||||Treatment sequence effect: p=0.33; distribution phenotype (localised, widespread) effect: p=0.55; threshold for statistical significance: p<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and distribution phenotype (localised, widespread) as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: distribution phenotype (localised, widespread)."|
1620944|NCT02310646|2977963|Superiority or Other|||||||0.29||||||Treatment sequence effect: p=0.34; baseline disease severity effect: p=0.29; threshold for statistical significance: p<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and baseline disease severity as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: Baseline disease severity (mild, moderate, severe)."|
1620945|NCT02310646|2977963|Superiority or Other||||||=|0||||||Treatment sequence effect: p=0.34; age effect: p=0.001; threshold for statistical significance: p<0.05.|Regression, Logistic|2-factor logistic regression with age and treatment sequence as factors||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: age (18-39 years, 40-59 years, ≥60 years)."|
1620946|NCT02310646|2977963|Superiority or Other||||||=|0.2||||||Treatment sequence effect: p=0.28; gender effect: p=0.20; threshold for statistical significance: p<0.05|Regression, Logistic|2-factor logistic regression model with treatment sequence and gender as factors.||"The statistical significance of each of the 7 baseline characteristics was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Baseline factor: gender (male, female)."|
1620947|NCT02310581|2977965|Other||LS Mean Difference|56.879|Standard Error of the Mean|18.3984||0.004|2-Sided|95.0|19.45|94.31|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1620948|NCT02310581|2977965|Other||LS Mean Difference|50.284|Standard Error of the Mean|17.5979||0.007|2-Sided|95.0|14.48|86.09|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1620949|NCT02310581|2977965|Other||LS Mean Difference|63.881|Standard Error of the Mean|18.3971||0.001|2-Sided|95.0|26.45|101.31|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1620950|NCT02310581|2977966|Other||LS Mean Difference|22.143|Standard Error of the Mean|8.1997||0.011|2-Sided|95.0|5.46|38.83|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1620951|NCT02310581|2977966|Other||LS Mean Difference|21.605|Standard Error of the Mean|7.8429||0.009|2-Sided|95.0|5.65|37.56|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1620952|NCT02310581|2977966|Other||LS Mean Difference|26.665|Standard Error of the Mean|8.1991||3|2-Sided|95.0|9.98|43.35|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1620953|NCT02310581|2977967|Other||LS Mean Difference|10.063|Standard Error of the Mean|4.7393||0.041|2-Sided|95.0|0.42|19.7|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1620954|NCT02310581|2977967|Other||LS Mean Difference|8.056|Standard Error of the Mean|4.5331||0.085|2-Sided|95.0|-1.17|17.28|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1620955|NCT02310581|2977967|Other||LS Mean Difference|14.398|Standard Error of the Mean|4.739||0.005|2-Sided|95.0|4.76|24.04|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1620956|NCT02310581|2977970|Other||LS Mean Difference|64.485|Standard Error of the Mean|39.2459||0.11|2-Sided|95.0|-15.36|144.33|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1620957|NCT02310581|2977970|Other||LS Mean Difference|86.316|Standard Error of the Mean|37.5385||0.028|2-Sided|95.0|9.94|162.69|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1621255|NCT02307682|2978235|Other|Treatment difference|Least squares mean difference|-0.26|||||2-Sided|95.0|-1.9|1.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48|
1620958|NCT02310581|2977970|Other||LS Mean Difference|104.973|Standard Error of the Mean|39.2433||0.012|2-Sided|95.0|25.13|184.81|||ANCOVA|The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.|||
1620959|NCT02310568|2977971|Superiority or Other||Odds Ratio (OR)|0.58|||||2-Sided|90.0|0.23|1.49||||||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).|
1620960|NCT02310568|2977971|Superiority or Other||Odds Ratio (OR)|1.64|||||2-Sided|90.0|0.39|6.88||||||(PF-06372865 2.5 mg – Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).|
1620961|NCT02310568|2977971|Superiority or Other||Odds Ratio (OR)|0.95|||||2-Sided|90.0|0.37|2.45||||||(PF-06372865 7.5 mg – Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).|
1620962|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|1.07||0.752|2-Sided|90.0|-1.5|2.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect.|
1620963|NCT02310568|2977972|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|1.09||0.708|2-Sided|90.0|-2.3|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect.|
1620964|NCT02310568|2977972|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|1.11||0.949|2-Sided|90.0|-2.0|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect.|
1620965|NCT02310568|2977972|Superiority or Other||LS Mean Difference|1.1|Standard Error of the Mean|1.81||0.538|2-Sided|90.0|-2.0|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620966|NCT02310568|2977972|Superiority or Other||LS Mean Difference|-1.8|Standard Error of the Mean|1.95||0.362|2-Sided|90.0|-5.2|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620967|NCT02310568|2977972|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|1.96||0.728|2-Sided|90.0|-4.1|2.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620968|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.9|Standard Error of the Mean|1.5||0.555|2-Sided|90.0|-1.7|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620969|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|1.6||0.942|2-Sided|90.0|-2.7|2.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620970|NCT02310568|2977972|Superiority or Other||LS Mean Difference|1.0|Standard Error of the Mean|1.62||0.538|2-Sided|90.0|-1.8|3.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620971|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.7|Standard Error of the Mean|1.43||0.635|2-Sided|90.0|-1.8|3.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620972|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.9|Standard Error of the Mean|1.56||0.56|2-Sided|90.0|-1.8|3.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620973|NCT02310568|2977972|Superiority or Other||LS Mean Difference|1.6|Standard Error of the Mean|1.56||0.313|2-Sided|90.0|-1.1|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620974|NCT02310568|2977972|Superiority or Other||LS Mean Difference|1.2|Standard Error of the Mean|1.27||0.369|2-Sided|90.0|-1.0|3.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620975|NCT02310568|2977972|Superiority or Other||LS Mean Difference|-0.8|Standard Error of the Mean|1.38||0.559|2-Sided|90.0|-3.2|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1622377|NCT02295020|2979029|Superiority or Other|||||||0.449|||||||t-test, 2 sided||||
1620976|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|1.38||0.804|2-Sided|90.0|-2.0|2.7|||LS Mean Difference|||(PF-06372865 7.5 mg – Placebo). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620977|NCT02310568|2977972|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|1.17||0.704|2-Sided|90.0|-2.4|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 4: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620978|NCT02310568|2977972|Superiority or Other||LS Mean Difference|1.0|Standard Error of the Mean|1.0||0.322|2-Sided|90.0|-0.7|2.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 4: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620979|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.5|Standard Error of the Mean|1.04||0.599|2-Sided|90.0|-1.2|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 4: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620980|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.99||0.987|2-Sided|90.0|-1.7|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620981|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.9|Standard Error of the Mean|0.85||0.294|2-Sided|90.0|-0.5|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620982|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.9|Standard Error of the Mean|0.88||0.321|2-Sided|90.0|-0.6|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620983|NCT02310568|2977972|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|0.95||0.611|2-Sided|90.0|-2.1|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620984|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|0.82||0.463|2-Sided|90.0|-0.8|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620985|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.86||0.892|2-Sided|90.0|-1.3|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620986|NCT02310568|2977972|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.92||0.914|2-Sided|90.0|-1.6|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620987|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|0.78||0.439|2-Sided|90.0|-0.7|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620988|NCT02310568|2977972|Superiority or Other||LS Mean Difference|0.5|Standard Error of the Mean|0.82||0.539|2-Sided|90.0|-0.9|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620989|NCT02310568|2977973|Superiority or Other||LS Mean Difference|0.4|Standard Error of the Mean|1.12||0.704|2-Sided|90.0|-1.5|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect.|
1620990|NCT02310568|2977973|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|1.13||0.991|2-Sided|90.0|-2.0|1.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect.|
1620991|NCT02310568|2977973|Superiority or Other||LS Mean Difference|0.4|Standard Error of the Mean|1.15||0.72|2-Sided|90.0|-1.6|2.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect.|
1621073|NCT02310568|2977978|Superiority or Other||Odds Ratio (OR)|1.26|||||2-Sided|90.0|0.69|2.32||||||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.|
1620992|NCT02310568|2977973|Superiority or Other||LS Mean Difference|2.6|Standard Error of the Mean|1.75||0.159|2-Sided|90.0|-0.5|5.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620993|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-1.5|Standard Error of the Mean|1.9||0.44|2-Sided|90.0|-4.8|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620994|NCT02310568|2977973|Superiority or Other||LS Mean Difference|1.1|Standard Error of the Mean|1.93||0.586|2-Sided|90.0|-2.3|4.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620995|NCT02310568|2977973|Superiority or Other||LS Mean Difference|1.6|Standard Error of the Mean|1.36||0.245|2-Sided|90.0|-0.7|4.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620996|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|1.49||0.719|2-Sided|90.0|-3.1|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620997|NCT02310568|2977973|Superiority or Other||LS Mean Difference|1.1|Standard Error of the Mean|1.51||0.482|2-Sided|90.0|-1.5|3.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620998|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-1.0|Standard Error of the Mean|1.36||0.477|2-Sided|90.0|-3.3|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1620999|NCT02310568|2977973|Superiority or Other||LS Mean Difference|1.5|Standard Error of the Mean|1.52||0.34|2-Sided|90.0|-1.1|4.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621000|NCT02310568|2977973|Superiority or Other||LS Mean Difference|0.5|Standard Error of the Mean|1.53||0.744|2-Sided|90.0|-2.1|3.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621001|NCT02310568|2977973|Superiority or Other||LS Mean Difference|0.9|Standard Error of the Mean|1.22||0.487|2-Sided|90.0|-1.3|3.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621002|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|1.37||0.764|2-Sided|90.0|-2.8|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28). Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621003|NCT02310568|2977973|Superiority or Other||LS Mean Difference|0.4|Standard Error of the Mean|1.38||0.747|2-Sided|90.0|-1.9|2.8|||LS Mean Difference|||(PF-06372865 7.5 mg – Placebo). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621004|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-1.7|Standard Error of the Mean|1.4||0.224|2-Sided|90.0|-4.0|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 4: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621005|NCT02310568|2977973|Superiority or Other||LS Mean Difference|1.5|Standard Error of the Mean|1.24||0.237|2-Sided|90.0|-0.6|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 4: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621006|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|1.23||0.848|2-Sided|90.0|-2.3|1.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 4: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621007|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|1.24||0.6|2-Sided|90.0|-2.7|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1622107|NCT02301897|2978576|Superiority|||||||0.279|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1621008|NCT02310568|2977973|Superiority or Other||LS Mean Difference|0.4|Standard Error of the Mean|1.1||0.705|2-Sided|90.0|-1.4|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621009|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|1.09||0.831|2-Sided|90.0|-2.1|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621010|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|1.28||0.574|2-Sided|90.0|-2.9|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621011|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|1.14||0.759|2-Sided|90.0|-2.2|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621012|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-1.1|Standard Error of the Mean|1.14||0.347|2-Sided|90.0|-3.0|0.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621013|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|1.05||0.852|2-Sided|90.0|-1.9|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621014|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.92||0.708|2-Sided|90.0|-1.9|1.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621015|NCT02310568|2977973|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|0.93||0.562|2-Sided|90.0|-2.1|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621016|NCT02310568|2977976|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.34||0.778|2-Sided|90.0|-0.5|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect.|
1621017|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.35||0.515|2-Sided|90.0|-0.8|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect.|
1621018|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.36||0.714|2-Sided|90.0|-0.8|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect.|
1621019|NCT02310568|2977976|Superiority or Other||LS Mean Difference|0.5|Standard Error of the Mean|0.6||0.445|2-Sided|90.0|-0.6|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621020|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|0.63||0.271|2-Sided|90.0|-1.8|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621021|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.65||0.701|2-Sided|90.0|-1.4|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621022|NCT02310568|2977976|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|0.47||0.188|2-Sided|90.0|-0.2|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621023|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.5||0.643|2-Sided|90.0|-1.1|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621074|NCT02310568|2977978|Superiority or Other||Odds Ratio (OR)|0.6|||||2-Sided|90.0|0.23|1.54||||||(PF-06372865 2.5 mg – Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.|
1621024|NCT02310568|2977976|Superiority or Other||LS Mean Difference|0.4|Standard Error of the Mean|0.51||0.442|2-Sided|90.0|-0.5|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621025|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.51||0.632|2-Sided|90.0|-1.1|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621026|NCT02310568|2977976|Superiority or Other||LS Mean Difference|0.4|Standard Error of the Mean|0.55||0.507|2-Sided|90.0|-0.6|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621027|NCT02310568|2977976|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.56||0.827|2-Sided|90.0|-0.9|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621028|NCT02310568|2977976|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.46||0.836|2-Sided|90.0|-0.7|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621029|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.49||0.757|2-Sided|90.0|-1.0|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621030|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.5||0.94|2-Sided|90.0|-0.9|0.8|||LS Mean Difference|||(PF-06372865 7.5 mg – Placebo). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621031|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.34||0.433|2-Sided|90.0|-0.8|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 4: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621032|NCT02310568|2977976|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.3||0.389|2-Sided|90.0|-0.2|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 4: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621033|NCT02310568|2977976|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.3||0.965|2-Sided|90.0|-0.5|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 4: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621034|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|0.33||0.16|2-Sided|90.0|-1.0|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621035|NCT02310568|2977976|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.29||0.348|2-Sided|90.0|-0.2|0.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621036|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.29||0.502|2-Sided|90.0|-0.7|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621037|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.27||0.39|2-Sided|90.0|-0.7|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621038|NCT02310568|2977976|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.24||0.925|2-Sided|90.0|-0.4|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621039|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.24||0.291|2-Sided|90.0|-0.7|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621256|NCT02307682|2978235|Other|Treatment difference|Least squares mean difference|-0.2|||||2-Sided|95.0|-1.8|1.4|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48|
1621040|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.24||0.377|2-Sided|90.0|-0.6|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621041|NCT02310568|2977976|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.2||0.996|2-Sided|90.0|-0.3|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621042|NCT02310568|2977976|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.21||0.325|2-Sided|90.0|-0.6|0.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect.|
1621043|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|0.31||0.436|2-Sided|90.0|-0.3|0.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect.|
1621044|NCT02310568|2977977|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.31||0.407|2-Sided|90.0|-0.8|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect.|
1621045|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.33||0.946|2-Sided|90.0|-0.6|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect.|
1621046|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.5|Standard Error of the Mean|0.54||0.272|2-Sided|90.0|-0.4|1.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621047|NCT02310568|2977977|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|0.58||0.329|2-Sided|90.0|-1.7|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621048|NCT02310568|2977977|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.6||0.858|2-Sided|90.0|-1.2|0.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621049|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|0.42||0.208|2-Sided|90.0|-0.2|1.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621050|NCT02310568|2977977|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.45||0.567|2-Sided|90.0|-1.0|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621051|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.47||0.548|2-Sided|90.0|-0.5|1.1|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621052|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|0.48||0.667|2-Sided|90.0|-0.6|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621053|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.51||0.873|2-Sided|90.0|-0.8|1.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621054|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.53||0.589|2-Sided|90.0|-0.6|1.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621055|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|0.45||0.18|2-Sided|90.0|-0.2|1.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621075|NCT02310568|2977978|Superiority or Other||Odds Ratio (OR)|0.75|||||2-Sided|90.0|0.45|1.26||||||(PF-06372865 7.5 mg – Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.|
1622378|NCT02295020|2979031|Superiority or Other|||||||0.311|||||||t-test, 2 sided||||
1621056|NCT02310568|2977977|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|0.48||0.356|2-Sided|90.0|-1.3|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621057|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|0.5||0.743|2-Sided|90.0|-0.7|1.0|||LS Mean Difference|||(PF-06372865 7.5 mg – Placebo). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621058|NCT02310568|2977977|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.28||0.844|2-Sided|90.0|-0.5|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 4: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621059|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.25||0.624|2-Sided|90.0|-0.3|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 4: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621060|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.25||0.796|2-Sided|90.0|-0.4|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 4: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621061|NCT02310568|2977977|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.27||0.433|2-Sided|90.0|-0.7|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621062|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|0.23||0.49|2-Sided|90.0|-0.2|0.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621063|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.24||0.848|2-Sided|90.0|-0.4|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621064|NCT02310568|2977977|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.27||0.775|2-Sided|90.0|-0.5|0.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621065|NCT02310568|2977977|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.24||0.683|2-Sided|90.0|-0.5|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621066|NCT02310568|2977977|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.24||0.47|2-Sided|90.0|-0.6|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621067|NCT02310568|2977977|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.23||0.634|2-Sided|90.0|-0.3|0.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621068|NCT02310568|2977977|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.2||0.416|2-Sided|90.0|-0.5|0.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621069|NCT02310568|2977977|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.21||0.801|2-Sided|90.0|-0.4|0.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).|
1621070|NCT02310568|2977978|Superiority or Other||Odds Ratio (OR)|0.58|||||2-Sided|90.0|0.16|2.09||||||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.|
1621071|NCT02310568|2977978|Superiority or Other||Odds Ratio, log|2.13|||||2-Sided|90.0|0.19|24.51||||||(PF-06372865 2.5 mg – Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.|
1621072|NCT02310568|2977978|Superiority or Other||Odds Ratio (OR)|1.24|||||2-Sided|90.0|0.27|5.78||||||(PF-06372865 7.5 mg – Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.|
1621257|NCT02307682|2978235|Other|Treatment difference|Least squares mean difference|0.63|||||2-Sided|95.0|-0.9|2.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24|
1621076|NCT02310568|2977979|Superiority or Other||LS Mean Difference|-0.6|Standard Error of the Mean|1.9||0.771|2-Sided|90.0|-3.7|2.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.|
1621077|NCT02310568|2977979|Superiority or Other||LS Mean Difference|1.5|Standard Error of the Mean|1.67||0.362|2-Sided|90.0|-1.2|4.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.|
1621078|NCT02310568|2977979|Superiority or Other||LS Mean Difference|1.0|Standard Error of the Mean|1.72||0.575|2-Sided|90.0|-1.9|3.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 3: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.|
1621079|NCT02310568|2977979|Superiority or Other||LS Mean Difference|-1.4|Standard Error of the Mean|1.99||0.496|2-Sided|90.0|-4.7|2.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.|
1621080|NCT02310568|2977979|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|1.74||0.736|2-Sided|90.0|-2.3|3.5|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.|
1621081|NCT02310568|2977979|Superiority or Other||LS Mean Difference|-0.8|Standard Error of the Mean|1.81||0.67|2-Sided|90.0|-3.8|2.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 2: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.|
1621082|NCT02310568|2977979|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|1.6||0.817|2-Sided|90.0|-3.0|2.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.|
1621083|NCT02310568|2977979|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|1.38||0.647|2-Sided|90.0|-1.7|2.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.|
1621084|NCT02310568|2977979|Superiority or Other||Least Squares Mean Difference|0.3|Standard Error of the Mean|1.45||0.856|2-Sided|90.0|-2.2|2.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 1: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.|
1621085|NCT02310568|2977980|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|0.66||0.412|2-Sided|90.0|-0.6|1.7|||ANCOVA|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621086|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-0.6|Standard Error of the Mean|0.7||0.407|2-Sided|90.0|-1.8|0.6|||ANCOVA|||(PF-06372865 2.5 mg – Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621087|NCT02310568|2977980|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.69||0.954|2-Sided|90.0|-1.2|1.2|||ANCOVA|||(PF-06372865 7.5 mg – Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621088|NCT02310568|2977980|Superiority or Other||LS Mean Difference|1.0|Standard Error of the Mean|0.79||0.212|2-Sided|90.0|-0.4|2.4|||ANCOVA|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621089|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-1.8|Standard Error of the Mean|0.8||0.041|2-Sided|90.0|-3.2|-0.4|||ANCOVA|||(PF-06372865 2.5 mg – Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621090|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-0.8|Standard Error of the Mean|0.78||0.347|2-Sided|90.0|-2.1|0.6|||ANCOVA|||(PF-06372865 7.5 mg – Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1622108|NCT02301897|2978576|Superiority|||||||0.0688|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1621091|NCT02310568|2977980|Superiority or Other||LS Mean Difference|0.8|Standard Error of the Mean|0.81||0.359|2-Sided|90.0|-0.6|2.2|||ANCOVA|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621092|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-1.0|Standard Error of the Mean|0.95||0.332|2-Sided|90.0|-2.6|0.7|||ANCOVA|||(PF-06372865 2.5 mg – Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621093|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.95||0.841|2-Sided|90.0|-1.8|1.5|||ANCOVA|||(PF-06372865 7.5 mg – Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621094|NCT02310568|2977980|Superiority or Other||LS Mean Difference|2.1|Standard Error of the Mean|1.92||0.296|2-Sided|90.0|-1.3|5.4|||ANCOVA|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621095|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-2.1|Standard Error of the Mean|2.16||0.353|2-Sided|90.0|-5.8|1.7|||ANCOVA|||(PF-06372865 2.5 mg – Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621096|NCT02310568|2977980|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|2.11||0.998|2-Sided|90.0|-3.7|3.7|||ANCOVA|||(PF-06372865 7.5 mg – Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621097|NCT02310568|2977980|Superiority or Other||LS Mean Difference|0.9|Standard Error of the Mean|1.11||0.417|2-Sided|90.0|-1.0|2.9|||ANCOVA|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621098|NCT02310568|2977980|Superiority or Other||LS Mean Difference|1.26|Standard Error of the Mean|-0.5||0.691|2-Sided|90.0|-2.7|1.7|||ANCOVA|||(PF-06372865 2.5 mg – Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621099|NCT02310568|2977980|Superiority or Other||LS Mean Difference|0.4|Standard Error of the Mean|1.22||0.738|2-Sided|90.0|-1.7|2.5|||ANCOVA|||(PF-06372865 7.5 mg – Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621100|NCT02310568|2977980|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|0.7||0.799|2-Sided|90.0|-1.0|1.3|||ANCOVA|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621101|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|0.6||0.26|2-Sided|90.0|-1.7|0.3|||ANCOVA|||(PF-06372865 2.5 mg – Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621102|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|0.62||0.429|2-Sided|90.0|-1.5|0.5|||ANCOVA|||(PF-06372865 7.5 mg – Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621130|NCT02310568|2977982|Superiority or Other||LS Mean Difference|2.0|Standard Error of the Mean|2.09||0.352|2-Sided|90.0|-1.6|5.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).|
1621103|NCT02310568|2977980|Superiority or Other||LS Mean Difference|1.2|Standard Error of the Mean|1.36||0.399|2-Sided|90.0|-1.2|3.6|||ANCOVA|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621104|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-1.9|Standard Error of the Mean|1.43||0.217|2-Sided|90.0|-4.4|0.7|||ANCOVA|||(PF-06372865 2.5 mg – Placebo). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621105|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|1.38||0.635|2-Sided|90.0|-3.1|1.8|||ANCOVA|||(PF-06372865 7.5 mg – Placebo). Work Sub-Scale Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621106|NCT02310568|2977980|Superiority or Other||LS Mean Difference|0.9|Standard Error of the Mean|0.82||0.285|2-Sided|0.285|-0.5|2.3|||ANCOVA|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621107|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-1.7|Standard Error of the Mean|0.7||0.016|2-Sided|90.0|-2.9|-0.6|||ANCOVA|||(PF-06372865 2.5 mg – Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621108|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-0.8|Standard Error of the Mean|0.73||0.249|2-Sided|90.0|-2.1|0.4|||ANCOVA|||(PF-06372865 7.5 mg – Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621109|NCT02310568|2977980|Superiority or Other||LS Mean Difference|1.6|Standard Error of the Mean|1.43||0.272|2-Sided|90.0|-0.9|4.1|||ANCOVA|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621110|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-2.0|Standard Error of the Mean|1.8||0.281|2-Sided|90.0|-5.1|1.1|||ANCOVA|||(PF-06372865 2.5 mg – Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621111|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|1.78||0.834|2-Sided|90.0|-3.5|2.7|||ANCOVA|||(PF-06372865 7.5 mg – Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621112|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.74||0.885|2-Sided|90.0|-1.3|1.1|||ANCOVA|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621113|NCT02310568|2977980|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.62||0.87|2-Sided|90.0|-0.9|1.1|||ANCOVA|||(PF-06372865 2.5 mg – Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621114|NCT02310568|2977980|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.65||0.994|2-Sided|90.0|-1.1|1.1|||ANCOVA|||(PF-06372865 7.5 mg – Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621131|NCT02310568|2977982|Superiority or Other||LS Mean Difference|-1.1|Standard Error of the Mean|2.36||0.646|2-Sided|90.0|-5.2|3.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).|
1622109|NCT02301897|2978576|Superiority|||||||0.2624|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1621115|NCT02310568|2977980|Superiority or Other||LS Mean Difference|3.5|Standard Error of the Mean|3.3||0.299|2-Sided|90.0|-2.2|9.3|||ANCOVA|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Total Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621116|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-2.4|Standard Error of the Mean|4.0||0.553|2-Sided|90.0|-9.4|4.5|||ANCOVA|||(PF-06372865 2.5 mg – Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621117|NCT02310568|2977980|Superiority or Other||LS Mean Difference|1.1|Standard Error of the Mean|3.85||0.775|2-Sided|90.0|-5.6|7.8|||ANCOVA|||(PF-06372865 7.5 mg – Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621118|NCT02310568|2977980|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|1.94||0.736|2-Sided|90.0|-2.6|3.8|||ANCOVA|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621119|NCT02310568|2977980|Superiority or Other||LS Mean Difference|-1.7|Standard Error of the Mean|1.65||0.302|2-Sided|90.0|-4.5|1.0|||ANCOVA|||(PF-06372865 2.5 mg – Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621120|NCT02310568|2977980|Superiority or Other||Least Squares Mean Difference|-1.1|Standard Error of the Mean|1.72||0.514|2-Sided|90.0|-4.0|1.7|||ANCOVA|||(PF-06372865 7.5 mg – Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.|
1621121|NCT02310568|2977982|Superiority or Other||LS Mean Difference|3.8|Standard Error of the Mean|3.51||0.295|2-Sided|90.0|-2.3|9.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).|
1621122|NCT02310568|2977982|Superiority or Other||LS Mean Difference|-3.0|Standard Error of the Mean|3.89||0.449|2-Sided|90.0|-9.8|3.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).|
1621123|NCT02310568|2977982|Superiority or Other||LS Mean Difference|0.8|Standard Error of the Mean|3.92||0.846|2-Sided|90.0|-6.0|7.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 8: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).|
1621124|NCT02310568|2977982|Superiority or Other||LS Mean Difference|2.5|Standard Error of the Mean|2.42||0.308|2-Sided|90.0|-1.7|6.7|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).|
1621125|NCT02310568|2977982|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|2.69||0.939|2-Sided|90.0|-4.5|4.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).|
1621126|NCT02310568|2977982|Superiority or Other||LS Mean Difference|2.7|Standard Error of the Mean|2.71||0.324||90.0|-2.0|7.4|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 7: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).|
1621127|NCT02310568|2977982|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|2.65||0.889|2-Sided|90.0|-5.0|4.2|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).|
1621128|NCT02310568|2977982|Superiority or Other||LS Mean Difference|2.5|Standard Error of the Mean|2.99||0.422|2-Sided|90.0|-2.7|7.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).|
1621129|NCT02310568|2977982|Superiority or Other||LS Mean Difference|2.1|Standard Error of the Mean|2.99||0.495|2-Sided|90.0|-3.1|7.3|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 6: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).|
1621258|NCT02307682|2978235|Other|Treatment difference|Least squares mean difference|0.9|||||2-Sided|95.0|-0.5|2.3|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24|
1621132|NCT02310568|2977982|Superiority or Other||LS Mean Difference|0.9|Standard Error of the Mean|2.36||0.708|2-Sided|90.0|-3.2|5.0|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Week 5: Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).|
1621133|NCT02310568|2977984|Superiority or Other||LS Mean Difference|-2.0|Standard Error of the Mean|2.22||0.36|2-Sided|90.0|-5.7|1.6|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – PF-06372865 2.5 mg). Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.|
1621134|NCT02310568|2977984|Superiority or Other||LS Mean Difference|2.6|Standard Error of the Mean|1.94||0.184|2-Sided|90.0|-0.6|5.8|||Mixed-Effects Model Repeated Measure|||(PF-06372865 2.5 mg – Placebo). Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.|
1621135|NCT02310568|2977984|Superiority or Other||Least Square (LS) Mean Difference|0.6|Standard Error of the Mean|2.01||0.784|2-Sided|90.0|-2.8|3.9|||Mixed-Effects Model Repeated Measure|||(PF-06372865 7.5 mg – Placebo). Repeated measures model included week*treatment and baseline*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.|
1621136|NCT02310100|2977987|Other|One group comparison to a performance goal.|binomial proportion|0.081||||0.0013|1-Sided|95.0||0.124|||Exact binomial|||H0: PS ≥ 16.2% Ha: PS < 16.2% where PS is the primary safety endpoint rate|
1621137|NCT02310100|2977988|Other|This is a one-group comparison to a performance goal.|binomial proportion|0.673||||0.0008|1-Sided|95.0|0.608||||Exact binomial|||H0: PE ≤ 54.9% Ha: PE > 54.9% Where PE is the primary effectiveness endpoint rate.|
1621138|NCT02309359|2978032|Other|Under the assumption of monotonicity, a Cochran-Armitage trend test was performed as the primary efficacy analysis. Data were analyzed according to the intent-to-treat (ITT) principle; thus, subjects were analyzed according to the treatment to which they were assigned. Subjects with missing ACR20 response at Week 12 were treated as non responders (non responder imputation approach).||||||0.172|||||||Cochran-Armitage trend test|||The null hypothesis of this test was that there is no difference in the percentage of subjects achieving ACR20 response between the treatment groups and the alternative hypothesis was that the percentage of subjects achieving ACR20 response increases with increasing dose level.|
1621139|NCT02308748|2978080|Superiority or Other||Mean Difference (Final Values)|2.9||||0.025|2-Sided|95.0|-1.0|6.7||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis||||
1621140|NCT02308748|2978081|Superiority or Other||Mean Difference (Final Values)|-20.5||||0.025|2-Sided|95.0|-25.5|-15.5||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in J-Tpeakc interval on the ECG measured in milliseconds when dofetilide is administered with lidocaine compared to when dofetilide is administered alone at evening dose on treatment day.|
1621141|NCT02308748|2978081|Superiority or Other||Mean Difference (Final Values)|-23.2||||0.025|2-Sided|95.0|-28.0|-18.3||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in J-Tpeakc interval on the ECG measured in milliseconds when dofetilide is administered with mexiletine compared to when dofetilide is administered alone at evening dose on treatment day.|
1621142|NCT02308748|2978081|Superiority or Other||Mean Difference (Final Values)|-19.7||||0.025|2-Sided|95.0|-25.2|-14.1||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in QTc interval on the ECG measured in milliseconds when dofetilide is administered with lidocaine compared to when dofetilide is administered alone at evening dose on treatment day.|
1621143|NCT02308748|2978081|Superiority or Other||Mean Difference (Final Values)|-19.8||||0.025|2-Sided|95.0|-25.2|-14.3||Adjustment for multiple comparisons was performed according to the Bonferroni method.|Mixed Models Analysis|||Change in QTc interval on the ECG measured in milliseconds when dofetilide is administered with mexiletine compared to when dofetilide is administered alone at evening dose on treatment day.|
1621144|NCT02308540|2978100|Other|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 19F|5.0|||||2-Sided|90.0|-11.64|22.97|||||||
1621145|NCT02308540|2978100|Other|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 19A|-5.9|||||2-Sided|90.0|-26.41|11.01|||||||
1621146|NCT02308540|2978100|Other|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 14|5.3|||||2-Sided|90.0|-12.15|24.01|||||||
1621147|NCT02308540|2978100|Other|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 6B|5.0|||||2-Sided|90.0|-12.35|22.97|||||||
1621148|NCT02308540|2978100|Other|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 5|0.0|||||2-Sided|90.0|-18.56|18.56|||||||
1621149|NCT02308540|2978100|Other|Exact confidence intervals around treatment group differences are calculated based on Newcombe score. Calculation of difference and confidence interval around the difference is not possible when all subjects in both groups are responders|Absolute difference for MOPA type 1|9.1|||||2-Sided|90.0|-15.55|36.11|||||||
1621168|NCT02308540|2978104|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 5 GMC Ratio|1.2|||<|0.0865|2-Sided|90.0|1.01|1.43|||t-test, 2 sided||||
1622110|NCT02301897|2978577|Superiority|||||||0.3437|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1621150|NCT02308540|2978102|Other|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 23F|-6.0|||||2-Sided|90.0|-12.77|0.4|||||||
1621151|NCT02308540|2978102|Other|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 19F|0.0|||||2-Sided|90.0|-4.22|4.33|||||||
1621152|NCT02308540|2978102|Other|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 19A|-5.9|||||2-Sided|90.0|-12.38|0.17|||||||
1621153|NCT02308540|2978102|Other|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 14|1.0|||||2-Sided|90.0|-4.0|6.27|||||||
1621154|NCT02308540|2978102|Other|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 9V|-3.0|||||2-Sided|90.0|-9.17|2.9|||||||
1621155|NCT02308540|2978102|Other|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 7F|-3.0|||||2-Sided|90.0|-7.95|1.1|||||||
1621156|NCT02308540|2978102|Other|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 6B|-7.9|||||2-Sided|90.0|-15.0|-1.01|||||||
1621157|NCT02308540|2978102|Other|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 6A|-12.0|||||2-Sided|90.0|-20.94|-2.97|||||||
1621158|NCT02308540|2978102|Other|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 5|3.0|||||2-Sided|90.0|-1.1|7.95|||||||
1621159|NCT02308540|2978102|Other|Treatment group differences were estimated by the difference in proportion of seroresponders, with 2-sided exact 90% CIs around the difference calculated using the unconditional exact method of Newcombe. Although inference regarding seroresponse was not of primary concern in this study, a 2-sided 90% CI that excluded 0 was indicative of statistically significant difference at p ≤ 0.10 not corrected for multiplicity analysis.|Absolute Difference for Type 1|-1.0|||||2-Sided|90.0|-5.13|2.66|||||||
1621160|NCT02308540|2978104|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 23F GMC Ratio|0.58||||0.0001|2-Sided|90.0|0.46|0.73|||t-test, 2 sided||||
1621161|NCT02308540|2978104|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19F GMC Ratio|0.72||||0.004|2-Sided|90.0|0.6|0.87|||t-test, 2 sided||||
1621162|NCT02308540|2978104|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19A GMC Ratio|0.29|||<|0.0001|2-Sided|90.0|0.22|0.36|||t-test, 2 sided||||
1621163|NCT02308540|2978104|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 14 GMC Ratio|1.11|||<|0.5234|2-Sided|90.0|0.85|1.45|||t-test, 2 sided||||
1621164|NCT02308540|2978104|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 9V GMC Ratio|0.49|||<|0.0001|2-Sided|90.0|0.41|0.59|||t-test, 2 sided||||
1621165|NCT02308540|2978104|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 7F GMC Ratio|0.56|||<|0.0001|2-Sided|90.0|0.47|0.68|||t-test, 2 sided||||
1621166|NCT02308540|2978104|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6B GMC Ratio|0.43|||<|0.0001|2-Sided|90.0|0.33|0.57|||t-test, 2 sided||||
1621167|NCT02308540|2978104|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6A GMC Ratio|0.56|||<|0.0006|2-Sided|90.0|0.43|0.74|||t-test, 2 sided||||
1621169|NCT02308540|2978104|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 1 GMC Ratio|0.89|||<|0.255|2-Sided|90.0|0.74|1.06|||t-test, 2 sided||||
1621170|NCT02308540|2978105|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 23F GMC Ratio|0.65||||0.2039|2-Sided|90.0|0.4|1.16|||Two-tailed from z-test||||
1621171|NCT02308540|2978105|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 19F GMC Ratio|0.76||||0.3278|2-Sided|90.0|0.48|1.23|||Two-tailed from z-test||||
1621172|NCT02308540|2978105|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 19A GMC Ratio|0.71||||0.3443|2-Sided|90.0|0.42|1.35|||Two-tailed from z-test||||
1621173|NCT02308540|2978105|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 14 GMC Ratio|1.76||||0.0713|2-Sided|90.0|1.02|2.79|||Two-tailed from z-test||||
1621174|NCT02308540|2978105|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 9V GMC Ratio|0.6||||0.097|2-Sided|90.0|0.38|1.03|||Two-tailed from z-test||||
1621175|NCT02308540|2978105|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 7F GMC Ratio|0.74||||0.2189|2-Sided|90.0|0.52|1.14|||Two-tailed from z-test||||
1621176|NCT02308540|2978105|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 6B GMC Ratio|0.82||||0.4456|2-Sided|90.0|0.57|1.31|||Two-tailed from z-test||||
1621177|NCT02308540|2978105|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 6A GMC Ratio|0.84||||0.5664|2-Sided|90.0|0.55|1.54|||Two-tailed from z-test||||
1621178|NCT02308540|2978105|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 5 GMC Ratio|0.69||||0.2059|2-Sided|90.0|0.45|1.2|||Two-tailed from z-test||||
1621179|NCT02308540|2978105|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates. Due to distributional characteristics, confidence intervals around GMCs and treatment-group ratio are estimated using bootstrap resampling (10,000 bootstrap samples).|Pn IgG type 1 GMC Ratio|0.75||||0.2653|2-Sided|90.0|0.54|1.31|||Two-tailed from z-test||||
1621180|NCT02308540|2978106|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 23F GMC Ratio|1.13||||0.7565|2-Sided|90.0|0.59|2.15|||t-test, 2 sided||||
1621181|NCT02308540|2978106|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19F GMC Ratio|1.67||||0.149|2-Sided|90.0|0.93|3.02|||t-test, 2 sided||||
1621182|NCT02308540|2978106|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 19A GMC Ratio|1.74||||0.2044|2-Sided|90.0|0.84|3.58|||t-test, 2 sided||||
1621183|NCT02308540|2978106|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 14 GMC Ratio|1.08||||0.806|2-Sided|90.0|0.65|1.79|||t-test, 2 sided||||
1621184|NCT02308540|2978106|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 9V GMC Ratio|0.56||||0.0313|2-Sided|90.0|0.37|0.87|||t-test, 2 sided||||
1621185|NCT02308540|2978106|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 7F GMC Ratio|0.76||||0.3365|2-Sided|90.0|0.47|1.22|||t-test, 2 sided||||
1621186|NCT02308540|2978106|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6B GMC Ratio|2.22||||0.046|2-Sided|90.0|1.16|4.24|||t-test, 2 sided||||
1621187|NCT02308540|2978106|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 6A GMC Ratio|4.69||||0.0003|2-Sided|90.0|2.46|8.94|||t-test, 2 sided||||
1621188|NCT02308540|2978106|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 5 GMC Ratio|0.74||||0.454|2-Sided|90.0|0.38|1.45|||t-test, 2 sided||||
1621189|NCT02308540|2978106|Other|GMC will be summarized by treatment group with corresponding two-sided 90% CIs based on the t-distribution to provide population estimates.|Pn IgG type 1 GMC Ratio|0.31||||0.0025|2-Sided|90.0|0.17|0.57|||t-test, 2 sided||||
1621190|NCT02308163|2978133|Superiority||LS mean|-20.41|Standard Error of the Mean|3.13|<|0.001|2-Sided|95.0|-26.59|-14.24||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621191|NCT02308163|2978133|Superiority||LS mean|-17.3|Standard Error of the Mean|3.39|<|0.001|2-Sided|95.0|-24.0|-10.61||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621192|NCT02308163|2978135|Superiority||LS mean|-23.67|Standard Error of the Mean|5.28|<|0.001|2-Sided|95.0|-34.16|-13.17|||Covariance model|No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621193|NCT02308163|2978135|Superiority||LS mean|-20.22|Standard Error of the Mean|5.12|<|0.001|2-Sided|95.0|-30.38|-10.06||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621194|NCT02308163|2978137|Superiority||LS mean|-22.01|Standard Error of the Mean|5.06|<|0.001|2-Sided|95.0|-32.06|-11.97||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621195|NCT02308163|2978137|Superiority||LS mean|-20.67|Standard Error of the Mean|4.92|<|0.001|2-Sided|95.0|-30.44|-10.89||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621196|NCT02308163|2978139|Superiority||LS mean|-10.17|Standard Error of the Mean|3.88||0.01|2-Sided|95.0|-17.88|-2.47||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621197|NCT02308163|2978139|Superiority||LS mean|-8.55|Standard Error of the Mean|3.81||0.027|2-Sided|95.0|-16.11|-1.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: WPAI Change = Treatment + Baseline WPAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621198|NCT02308163|2978141|Superiority||LS mean|6.23|Standard Error of the Mean|1.77|<|0.001|2-Sided|95.0|2.74|9.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621199|NCT02308163|2978141|Superiority||LS mean|2.27|Standard Error of the Mean|1.8|<|0.21|2-Sided|95.0|-1.29|5.83||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621200|NCT02308163|2978143|Superiority||LS mean|3.25|Standard Error of the Mean|0.98||0.001|2-Sided|95.0|1.3|5.19||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621201|NCT02308163|2978143|Superiority||LS mean|2.89|Standard Error of the Mean|1.0||0.004|2-Sided|95.0|0.91|4.87||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621202|NCT02308163|2978145|Superiority||LS mean|6.98|Standard Error of the Mean|1.45|<|0.001|2-Sided|95.0|4.11|9.85||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621203|NCT02308163|2978145|Superiority||LS mean|6.87|Standard Error of the Mean|1.61|<|0.001|2-Sided|95.0|3.69|10.05||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SF-36v2 Change = Treatment + Baseline SF-36v2 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621204|NCT02308163|2978147|Superiority||LS mean|-0.4|Standard Error of the Mean|0.07|<|0.001|2-Sided|95.0|-0.53|-0.26||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: HAQ-DI Change = Treatment + Baseline HAQ-DI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea., and Taiwan)|Treatment Difference vs Placebo|
1621253|NCT02307682|2978235|Other|Treatment difference|Least squares mean difference|-0.12|||||2-Sided|95.0|-1.9|1.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72|
1621205|NCT02308163|2978147|Superiority||LS mean|-0.34|Standard Error of the Mean|0.07|<|0.001|2-Sided|95.0|-0.48|-0.2||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: HAQ-DI Change = Treatment + Baseline HAQ-DI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea., and Taiwan)|Treatment Difference vs Placebo|
1621206|NCT02308163|2978148|Superiority|||||||0.035||||||No Multiplicity Adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Fisher Exact|||Treatment Difference vs Placebo|
1621207|NCT02308163|2978148|Superiority|||||||0.033||||||No Multiplicity Adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Fisher Exact|||Treatment Difference vs Placebo|
1621208|NCT02308163|2978150|Superiority||LS mean|-23.9|Standard Error of the Mean|3.21|<|0.001|2-Sided|95.0|-30.24|-17.57||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA of pain (100 mm VAS) Change = Treatment + Baseline SGA of pain (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621209|NCT02308163|2978150|Superiority||LS mean|-17.58|Standard Error of the Mean|3.44|<|0.001|2-Sided|95.0|-24.36|-10.81||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA of pain (100 mm VAS) Change = Treatment + Baseline SGA of pain (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621210|NCT02308163|2978152|Superiority||LS mean|-23.56|Standard Error of the Mean|3.18|<|0.001|2-Sided|95.0|-29.83|-17.28||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621211|NCT02308163|2978152|Superiority||LS mean|-16.88|Standard Error of the Mean|3.51|<|0.001|2-Sided|95.0|-23.81|-9.95||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SGA (100 mm VAS) Change = Treatment + Baseline SGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621212|NCT02308163|2978154|Superiority||LS mean|-23.14|Standard Error of the Mean|2.86|<|0.001|2-Sided|95.0|-28.78|-17.51||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621213|NCT02308163|2978154|Superiority||LS mean|-15.2|Standard Error of the Mean|3.14|<|0.001|2-Sided|95.0|-21.4|-9.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: PGA (100 mm VAS) Change = Treatment + Baseline PGA (100 mm VAS) + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621214|NCT02308163|2978156|Superiority||LS mean|-12.83|Standard Error of the Mean|1.58|<|0.001|2-Sided|95.0|-15.96|-9.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|ANCOVA||Based on ANCOVA Model: CDAI Change = Treatment + Baseline CDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621215|NCT02308163|2978156|Superiority||LS mean|-8.69|Standard Error of the Mean|1.77|<|0.001|2-Sided|95.0|-12.19|-5.2||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|ANCOVA||Based on ANCOVA Model: CDAI Change = Treatment + Baseline CDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621216|NCT02308163|2978160|Superiority||Odds Ratio (OR)|-14.43|Standard Error of the Mean|1.66|<|0.001|2-Sided|95.0|-17.71|-11.15||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SDAI Change = Treatment + Baseline SDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621217|NCT02308163|2978160|Superiority||LS Mean|-9.94|Standard Error of the Mean|1.89|<|0.001|2-Sided|95.0|-13.66|-6.22||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: SDAI Change = Treatment + Baseline SDAI + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621218|NCT02308163|2978166|Superiority||Odds Ratio (OR)|13.65|||<|0.001|2-Sided|95.0|6.39|29.17||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621219|NCT02308163|2978166|Superiority||Odds Ratio (OR)|3.82|||<|0.001||95.0|2.11|6.93||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621220|NCT02308163|2978168|Superiority||Odds Ratio, log|11.01|||<|0.001|2-Sided|95.0|4.07|29.74||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1622111|NCT02301897|2978577|Superiority|||||||0.557|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1621221|NCT02308163|2978168|Superiority||Odds Ratio (OR)|4.29|||<|0.006|2-Sided|95.0|1.52|12.08||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald's chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621222|NCT02308163|2978170|Superiority||Odds Ratio (OR)|16.78|||<|0.001|2-Sided|95.0|7.31|38.51||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621223|NCT02308163|2978170|Superiority||Odds Ratio (OR)|4.37|||<|0.001|2-Sided|95.0|2.38|8.04||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: Good or Moderate Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621224|NCT02308163|2978172|Superiority||Odds Ratio (OR)|10.86|||<|0.001|2-Sided|95.0|4.91|24.03||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621225|NCT02308163|2978172|Superiority||Odds Ratio (OR)|6.64|||<|0.001|2-Sided|95.0|2.98|14.83||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: Good Response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621226|NCT02308163|2978174|Superiority||LS mean|-21.14|Standard Error of the Mean|2.47|<|0.001|2-Sided|95.0|-26.01|-16.27||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: ESR Change = Treatment + Baseline ESR + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621227|NCT02308163|2978174|Superiority||LS mean|-10.9|Standard Error of the Mean|2.56|<|0.001|2-Sided|95.0|-15.95|-5.84||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: ESR Change = Treatment + Baseline ESR + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621228|NCT02308163|2978176|Superiority||LS mean|-1.677|Standard Error of the Mean|0.221|<|0.001|2-Sided|95.0|-2.114|-1.241||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: CRP Change = Treatment + Baseline CRP + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621229|NCT02308163|2978176|Superiority||LS Mean|-1.112|Standard Error of the Mean|0.22|<|0.001|2-Sided|95.0|-1.546|-0.679||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test|Covariance model||Based on analysis of covariance model: CRP Change = Treatment + Baseline CRP + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621230|NCT02308163|2978178|Superiority||Odds Ratio (OR)|8.19|||<|0.001|2-Sided|96.0|3.42|19.63||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: DAS28-ESR score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621231|NCT02308163|2978178|Superiority||Odds Ratio (OR)|3.24|||<|0.012|2-Sided|95.0|1.29|8.12||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: DAS28-ESR score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621232|NCT02308163|2978180|Superiority||Odds Ratio (OR)|9.66|||<|0.001|2-Sided|95.0|4.57|20.41||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: DAS28-CRP score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621233|NCT02308163|2978180|Superiority||Odds Ratio (OR)|5.8|||<|0.001|2-Sided|95.0|2.74|12.29||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: DAS28-CRP score ≤ 3.2 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621234|NCT02308163|2978182|Superiority||Odds Ratio (OR)|21.72||||0.003|2-Sided|95.0|2.83|166.66||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: DAS28-ESR score < 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.|
1621235|NCT02308163|2978184|Superiority||Odds Ratio (OR)|10.13|||<|0.001|2-Sided|95.0|3.76|27.27||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: DAS28-CRP score < 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1622112|NCT02301897|2978577|Superiority|||||||0.1605|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1621236|NCT02308163|2978184|Superiority||Odds Ratio (OR)|6.4|||<|0.001|2-Sided|95.0|2.31|17.67||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: DAS28-CRP score < 2.6 (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621237|NCT02308163|2978186|Superiority||LS mean|-5.3|Standard Error of the Mean|0.7|<|0.001|2-Sided|95.0|-6.8|-3.9||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621238|NCT02308163|2978186|Superiority||LS mean|-3.0|Standard Error of the Mean|0.8|<|0.001|2-Sided|95.0|-4.6|-1.4||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621239|NCT02308163|2978188|Superiority||LS mean|-6.1|Standard Error of the Mean|1.0|<|0.001|2-Sided|95.0|-8.1|-4.0||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621240|NCT02308163|2978188|Superiority||LS mean|-4.6|Standard Error of the Mean|1.1|<|0.001|2-Sided|95.0|-6.8|-2.4||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: TJC68 Change = Treatment + Baseline TJC68 + the prior biologic - DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621241|NCT02308163|2978190|Superiority||LS mean|-1.64|Standard Error of the Mean|0.17|<|0.001|2-Sided|95.0|-1.96|-1.31||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621242|NCT02308163|2978190|Superiority||LS mean|-1.03|Standard Error of the Mean|0.18|<|0.001|2-Sided|95.0|-1.38|-0.67||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621243|NCT02308163|2978192|Superiority||LS mean|-1.55|Standard Error of the Mean|0.16|<|0.001|2-Sided|95.0|-1.86|-1.24||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621244|NCT02308163|2978192|Superiority||LS mean|-1.06|Standard Error of the Mean|0.18|<|0.001|2-Sided|95.0|-1.41|-0.71||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Covariance model||Based on analysis of covariance model: DAS28 Change = Treatment + Baseline DAS28 + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621245|NCT02308163|2978194|Superiority||Odds Ratio (OR)|39.93|||<|0.001|2-Sided|95.0|5.29|301.61||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: ACR70-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo. Difference vs. Peficitinib 100mg was not estimable.|
1621246|NCT02308163|2978196|Superiority||Odds Ratio (OR)|7.86|||<|0.001|2-Sided|95.0|3.53|17.5||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: ACR50-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621247|NCT02308163|2978196|Superiority||Odds Ratio (OR)|4.79|||<|0.001|2-Sided|95.0|2.14|10.75||No multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: ACR50-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621248|NCT02308163|2978198|Superiority||Odds Ratio (OR)|6.59|||<|0.001|2-Sided|95.0|3.56|12.2||Closed testing procedure was used for multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: ACR20-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621249|NCT02308163|2978198|Superiority||Odds Ratio (OR)|3.13|||<|0.001|2-Sided|95.0|1.76|5.58||Closed testing procedure was used for multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test.|Wald’s chi-squared test||Based on logistic regression model: ACR20-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan).|Treatment Difference vs Placebo|
1621250|NCT02307838|2978231|Superiority or Other||Difference in LS Means|-0.59||||0.0155|2-Sided|95.0|-1.07|-0.11|||ANCOVA||||
1621251|NCT02307682|2978235|Other|Treatment difference|Least squares mean difference|1.05|||||2-Sided|95.0|-0.9|3.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96|
1621252|NCT02307682|2978235|Other|Treatment difference|Least squares mean difference|0.75|||||2-Sided|95.0|-1.2|2.7|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96|
1621259|NCT02307682|2978236|Superiority||difference in proportions|-10.5||||0.0013|2-Sided|95.0|-17.1|-3.5||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for age categories (<75, >=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method.||
1621260|NCT02307682|2978236|Superiority||difference in proportions|-6.5||||0.0331|2-Sided|95.0|-13.2|0.3||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for age categories (<75, >=75 years) and treatment as fixed effect factors. 95% CI for the treatment difference estimated using bootstrap method.||
1621261|NCT02307682|2978237|Superiority|||||||0.0012||||||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Cochran-Mantel-Haenszel|CMH-test row mean score (scores=table) stratified by age categories (<75, ≥75 years) and baseline fluid status)|||
1621262|NCT02307682|2978237|Superiority|||||||0.0574||||||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Cochran-Mantel-Haenszel|CMH-test row mean score (scores=table) stratified by age categories (<75, ≥75 years) and baseline fluid status)|||
1621263|NCT02307682|2978238|Other||Difference in proportions|-12.9|||||2-Sided|95.0|-19.7|-6.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621264|NCT02307682|2978238|Other||Difference in proportions|-6.4|||||2-Sided|95.0|-13.2|0.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621265|NCT02307682|2978238|Other||Difference in proportions|-3.0|||||2-Sided|95.0|-9.8|2.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621266|NCT02307682|2978238|Other||Difference in proportions|4.1|||||2-Sided|95.0|-2.3|11.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621267|NCT02307682|2978238|Other||Difference in proportions|-10.3|||||2-Sided|95.0|-17.3|-3.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621268|NCT02307682|2978238|Other||Difference in proportions|-3.8|||||2-Sided|95.0|-10.8|3.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621269|NCT02307682|2978238|Other||Difference in proportions|-4.5|||||2-Sided|95.0|-11.2|1.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621270|NCT02307682|2978238|Other||Difference in proportions|-2.1|||||2-Sided|95.0|-8.9|4.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621271|NCT02307682|2978238|Other||Difference in proportions|-8.1|||||2-Sided|95.0|-15.3|-1.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621272|NCT02307682|2978238|Other||Difference in proportions|-4.4|||||2-Sided|95.0|-11.2|2.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621273|NCT02307682|2978238|Other||Difference in proportions|-3.4|||||2-Sided|95.0|-9.8|2.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621274|NCT02307682|2978238|Other||Difference in proportions|0.3|||||2-Sided|95.0|-5.9|7.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621275|NCT02307682|2978238|Other||Difference in proportions|-12.5|||||2-Sided|95.0|-19.8|-5.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621276|NCT02307682|2978238|Other||Difference in proportions|-8.9|||||2-Sided|95.0|-15.7|-1.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621277|NCT02307682|2978238|Other||Difference in proportions|2.2|||||2-Sided|95.0|-4.9|8.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621278|NCT02307682|2978238|Other||Difference in proportions|7.2|||||2-Sided|95.0|0.3|13.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621462|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-0.2|Standard Error of the Mean|5.95|||2-Sided|95.0|-11.9|11.5|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84|
1621279|NCT02307682|2978238|Other||Difference in proportions|-12.1|||||2-Sided|95.0|-19.5|-5.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621280|NCT02307682|2978238|Other||Difference in proportions|-7.6|||||2-Sided|95.0|-14.7|-0.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621281|NCT02307682|2978238|Other||Difference in proportions|-7.1|||||2-Sided|95.0|-14.0|-0.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621282|NCT02307682|2978238|Other||Difference in proportions|-3.8|||||2-Sided|95.0|-10.1|3.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621283|NCT02307682|2978238|Other||Difference in proportions|-6.9|||||2-Sided|95.0|-14.1|0.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621284|NCT02307682|2978238|Other||Difference in proportions|-3.2|||||2-Sided|95.0|-10.3|3.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621285|NCT02307682|2978238|Other||Difference in proportions|-4.9|||||2-Sided|95.0|-11.8|1.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621286|NCT02307682|2978238|Other||Difference in proportions|1.0|||||2-Sided|95.0|-5.4|8.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621287|NCT02307682|2978238|Superiority||Difference in proportions|-13.5||||0.0001|2-Sided|95.0|-20.7|-6.1||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621288|NCT02307682|2978238|Superiority||Difference in proportions|-10.5||||0.002|2-Sided|95.0|-17.4|-3.3||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621289|NCT02307682|2978238|Other||Difference in proportions|-0.1|||||2-Sided|95.0|-7.5|6.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621290|NCT02307682|2978238|Other||Difference in proportions|6.0|||||2-Sided|95.0|-0.8|13.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621291|NCT02307682|2978238|Other||Difference in proportions|-13.0|||||2-Sided|95.0|-20.5|-5.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621292|NCT02307682|2978238|Other||Difference in proportions|-8.2|||||2-Sided|95.0|-15.7|-0.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621293|NCT02307682|2978238|Other||Difference in proportions|-9.2|||||2-Sided|95.0|-16.2|-2.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621294|NCT02307682|2978238|Other||Difference in proportions|-5.9|||||2-Sided|95.0|-12.5|0.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621295|NCT02307682|2978238|Other||Difference in proportions|-10.3|||||2-Sided|95.0|-18.0|-3.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621296|NCT02307682|2978238|Other||Difference in proportions|-4.5|||||2-Sided|95.0|-12.0|3.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621297|NCT02307682|2978238|Other||Difference in proportions|-3.9|||||2-Sided|95.0|-11.8|2.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621298|NCT02307682|2978238|Other||Difference in proportions|1.7|||||2-Sided|95.0|-4.8|9.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621299|NCT02307682|2978238|Other||Difference in proportions|-23.2|||||2-Sided|95.0|-30.5|-16.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621300|NCT02307682|2978238|Other||Difference in proportions|-10.6|||||2-Sided|95.0|-17.7|-3.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621301|NCT02307682|2978238|Other||Difference in proportions|11.1|||||2-Sided|95.0|3.8|18.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621302|NCT02307682|2978238|Other||Difference in proportions|12.0|||||2-Sided|95.0|5.2|19.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621303|NCT02307682|2978238|Superiority||Difference in proportions|-18.2|||<|0.0001|2-Sided|95.0|-25.3|-10.9||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621304|NCT02307682|2978238|Superiority||Difference in proportions|-10.2|||<|0.003|2-Sided|95.0|-17.3|-2.5||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|Regression, Logistic||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621305|NCT02307682|2978238|Other||Difference in proportions|-10.2|||<||2-Sided|95.0|-17.4|-3.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621306|NCT02307682|2978238|Other||Difference in proportions|-8.2|||<||2-Sided|95.0|-14.8|-1.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621307|NCT02307682|2978238|Other||Difference in proportions|-12.1|||<||2-Sided|95.0|-19.7|-5.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621308|NCT02307682|2978238|Other||Difference in proportions|-9.3|||<||2-Sided|95.0|-16.6|-2.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621309|NCT02307682|2978238|Other||Difference in proportions|-7.4|||<||2-Sided|95.0|-15.3|-0.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621310|NCT02307682|2978238|Other||Difference in proportions|-6.7|||<||2-Sided|95.0|-14.1|0.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621311|NCT02307682|2978239|Other||Difference in proportions|-3.8|||||2-Sided|95.0|-8.5|0.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621312|NCT02307682|2978239|Other||Difference in proportions|-0.1|||||2-Sided|95.0|-5.3|5.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621313|NCT02307682|2978239|Other||Difference in proportions|-3.0|||||2-Sided|95.0|-7.6|1.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621314|NCT02307682|2978239|Other||Difference in proportions|-0.1|||||2-Sided|95.0|-4.9|5.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621315|NCT02307682|2978239|Other||Difference in proportions|-6.0|||||2-Sided|95.0|-11.0|-1.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621316|NCT02307682|2978239|Other||Difference in proportions|-2.2|||||2-Sided|95.0|-7.4|3.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621317|NCT02307682|2978239|Other||Difference in proportions|-5.4|||||2-Sided|95.0|-10.4|-0.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621318|NCT02307682|2978239|Other||Difference in proportions|-4.7|||||2-Sided|95.0|-9.8|0.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621319|NCT02307682|2978239|Other||Difference in proportions|-3.3|||||2-Sided|95.0|-8.5|1.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621320|NCT02307682|2978239|Other||Difference in proportions|-3.4|||||2-Sided|95.0|-8.4|1.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621321|NCT02307682|2978239|Other||Difference in proportions|-1.0|||||2-Sided|95.0|-5.8|3.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621322|NCT02307682|2978239|Other||Difference in proportions|-0.8|||||2-Sided|95.0|-5.2|4.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621323|NCT02307682|2978239|Other||Difference in proportions|-7.3|||||2-Sided|95.0|-12.2|-2.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621324|NCT02307682|2978239|Other||Difference in proportions|-5.4|||||2-Sided|95.0|-10.1|-0.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621325|NCT02307682|2978239|Other||Difference in proportions|-1.3|||||2-Sided|95.0|-6.3|3.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621326|NCT02307682|2978239|Other||Difference in proportions|-1.0|||||2-Sided|95.0|-6.0|4.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621327|NCT02307682|2978239|Other||Difference in proportions|-7.1|||||2-Sided|95.0|-12.5|-1.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621328|NCT02307682|2978239|Other||Difference in proportions|-5.2|||||2-Sided|95.0|-10.5|0.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621329|NCT02307682|2978239|Other||Difference in proportions|-2.7|||||2-Sided|95.0|-7.9|2.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621330|NCT02307682|2978239|Other||Difference in proportions|-2.3|||||2-Sided|95.0|-7.3|3.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621331|NCT02307682|2978239|Other||Difference in proportions|-6.2|||||2-Sided|95.0|-11.5|-0.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621332|NCT02307682|2978239|Other||Difference in proportions|-4.2|||||2-Sided|95.0|-9.4|1.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621333|NCT02307682|2978239|Other||Difference in proportions|-1.6|||||2-Sided|95.0|-6.2|2.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621334|NCT02307682|2978239|Other||Difference in proportions|-0.4|||||2-Sided|95.0|-5.1|4.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621335|NCT02307682|2978239|Other||Difference in proportions|-8.1|||||2-Sided|95.0|-13.6|-2.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621336|NCT02307682|2978239|Other||Difference in proportions|-4.0|||||2-Sided|95.0|-9.4|1.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621337|NCT02307682|2978239|Other||Difference in proportions|-4.7|||||2-Sided|95.0|-10.0|0.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621338|NCT02307682|2978239|Other||Difference in proportions|-1.2|||||2-Sided|95.0|-6.6|4.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621463|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|0.5|Standard Error of the Mean|6.01|||2-Sided|95.0|-11.3|12.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80|
1621339|NCT02307682|2978239|Other||Difference in proportions|-6.3|||||2-Sided|95.0|-12.2|-0.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621340|NCT02307682|2978239|Other||Difference in proportions|-4.6|||||2-Sided|95.0|-10.2|1.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621341|NCT02307682|2978239|Other||Difference in proportions|-5.4|||||2-Sided|95.0|-10.6|-0.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621342|NCT02307682|2978239|Other||Difference in proportions|-4.5|||||2-Sided|95.0|-9.5|0.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621343|NCT02307682|2978239|Other||Difference in proportions|-2.4|||||2-Sided|95.0|-7.5|3.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621344|NCT02307682|2978239|Other||Difference in proportions|-0.7|||||2-Sided|95.0|-6.2|5.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621345|NCT02307682|2978239|Other||Difference in proportions|-3.2|||||2-Sided|95.0|-8.4|1.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621346|NCT02307682|2978239|Other||Difference in proportions|1.1|||||2-Sided|95.0|-4.2|6.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621347|NCT02307682|2978239|Other||Difference in proportions|-7.1|||||2-Sided|95.0|-12.3|-1.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621348|NCT02307682|2978239|Other||Difference in proportions|-4.6|||||2-Sided|95.0|-9.7|0.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621349|NCT02307682|2978239|Other||Difference in proportions|2.1|||||2-Sided|95.0|-3.4|7.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621350|NCT02307682|2978239|Other||Difference in proportions|2.7|||||2-Sided|95.0|-2.8|8.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621351|NCT02307682|2978239|Other||Difference in proportions|-8.6|||||2-Sided|95.0|-14.4|-2.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621352|NCT02307682|2978239|Other||Difference in proportions|-6.5|||||2-Sided|95.0|-11.8|-1.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621353|NCT02307682|2978239|Other||Difference in proportions|-7.6|||||2-Sided|95.0|-12.8|-2.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621354|NCT02307682|2978239|Other||Difference in proportions|-6.5|||||2-Sided|95.0|-11.5|-1.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621355|NCT02307682|2978239|Other||Difference in proportions|-4.4|||||2-Sided|95.0|-9.8|1.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621356|NCT02307682|2978239|Other||Difference in proportions|-3.8|||||2-Sided|95.0|-9.3|1.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621357|NCT02307682|2978239|Other||Difference in proportions|-5.7|||||2-Sided|95.0|-11.4|0.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621358|NCT02307682|2978239|Other||Difference in proportions|-2.3|||||2-Sided|95.0|-7.7|3.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621466|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|1.8|Standard Error of the Mean|6.05|||2-Sided|95.0|-10.0|13.7|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76|
1621359|NCT02307682|2978240|Other||Difference in proportions|-4.9|||||2-Sided|95.0|-10.8|0.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621360|NCT02307682|2978240|Other||Difference in proportions|-0.9|||||2-Sided|95.0|-6.4|5.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621361|NCT02307682|2978240|Other||Difference in proportions|0.9|||||2-Sided|95.0|-4.3|6.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621362|NCT02307682|2978240|Other||Difference in proportions|3.8|||||2-Sided|95.0|-1.3|8.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621363|NCT02307682|2978240|Other||Difference in proportions|0.1|||||2-Sided|95.0|-5.3|5.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621364|NCT02307682|2978240|Other||Difference in proportions|3.9|||||2-Sided|95.0|-1.7|9.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621365|NCT02307682|2978240|Other||Difference in proportions|-0.3|||||2-Sided|95.0|-5.7|4.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621366|NCT02307682|2978240|Other||Difference in proportions|2.1|||||2-Sided|95.0|-3.3|7.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621367|NCT02307682|2978240|Other||Difference in proportions|0.2|||||2-Sided|95.0|-5.2|6.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621368|NCT02307682|2978240|Other||Difference in proportions|0.7|||||2-Sided|95.0|-4.7|6.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621369|NCT02307682|2978240|Other||Difference in proportions|1.3|||||2-Sided|95.0|-3.9|6.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621370|NCT02307682|2978240|Other||Difference in proportions|3.1|||||2-Sided|95.0|-1.9|8.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621371|NCT02307682|2978240|Other||Difference in proportions|-3.4|||||2-Sided|95.0|-9.0|1.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621372|NCT02307682|2978240|Other||Difference in proportions|-0.9|||||2-Sided|95.0|-6.1|4.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621373|NCT02307682|2978240|Other||Difference in proportions|2.2|||||2-Sided|95.0|-3.2|7.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621374|NCT02307682|2978240|Other||Difference in proportions|5.5|||||2-Sided|95.0|0.3|10.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621375|NCT02307682|2978240|Other||Difference in proportions|-3.0|||||2-Sided|95.0|-8.7|2.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621376|NCT02307682|2978240|Other||Difference in proportions|-0.8|||||2-Sided|95.0|-6.4|5.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621377|NCT02307682|2978240|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-5.8|5.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621378|NCT02307682|2978240|Other||Difference in proportions|-1.5|||||2-Sided|95.0|-6.6|3.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1622113|NCT02301897|2978577|Superiority|||||||0.3206|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1621379|NCT02307682|2978240|Other||Difference in proportions|-0.3|||||2-Sided|95.0|-5.8|5.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621380|NCT02307682|2978240|Other||Difference in proportions|2.3|||||2-Sided|95.0|-3.5|8.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621381|NCT02307682|2978240|Other||Difference in proportions|1.9|||||2-Sided|95.0|-3.2|7.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621382|NCT02307682|2978240|Other||Difference in proportions|3.3|||||2-Sided|95.0|-2.2|8.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621383|NCT02307682|2978240|Other||Difference in proportions|-0.8|||||2-Sided|95.0|-6.4|5.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621384|NCT02307682|2978240|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-6.2|5.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621385|NCT02307682|2978240|Other||Difference in proportions|1.9|||||2-Sided|95.0|-3.3|7.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621386|NCT02307682|2978240|Other||Difference in proportions|4.6|||||2-Sided|95.0|-1.0|9.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621387|NCT02307682|2978240|Other||Difference in proportions|-4.6|||||2-Sided|95.0|-10.2|1.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621388|NCT02307682|2978240|Other||Difference in proportions|-3.8|||||2-Sided|95.0|-9.6|1.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621389|NCT02307682|2978240|Other||Difference in proportions|-2.3|||||2-Sided|95.0|-7.8|3.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621390|NCT02307682|2978240|Other||Difference in proportions|-1.0|||||2-Sided|95.0|-6.4|4.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621391|NCT02307682|2978240|Other||Difference in proportions|-2.5|||||2-Sided|95.0|-8.4|3.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621392|NCT02307682|2978240|Other||Difference in proportions|0.0|||||2-Sided|95.0|-5.8|6.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621393|NCT02307682|2978240|Other||Difference in proportions|-0.8|||||2-Sided|95.0|-6.3|5.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621394|NCT02307682|2978240|Other||Difference in proportions|2.9|||||2-Sided|95.0|-2.1|8.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621395|NCT02307682|2978240|Other||Difference in proportions|-9.0|||||2-Sided|95.0|-14.9|-3.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621396|NCT02307682|2978240|Other||Difference in proportions|-4.0|||||2-Sided|95.0|-9.8|1.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621397|NCT02307682|2978240|Other||Difference in proportions|10.0|||||2-Sided|95.0|4.7|15.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621398|NCT02307682|2978240|Other||Difference in proportions|10.6|||||2-Sided|95.0|5.0|16.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621497|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-3.0|Standard Error of the Mean|5.55|||2-Sided|95.0|-13.9|7.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12|
1621399|NCT02307682|2978240|Other||Difference in proportions|-4.3|||||2-Sided|95.0|-10.0|1.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621400|NCT02307682|2978240|Other||Difference in proportions|-2.5|||||2-Sided|95.0|-8.3|3.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621401|NCT02307682|2978240|Other||Difference in proportions|0.3|||||2-Sided|95.0|-5.4|5.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621402|NCT02307682|2978240|Other||Difference in proportions|-2.7|||||2-Sided|95.0|-7.6|2.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621403|NCT02307682|2978240|Other||Difference in proportions|-1.5|||||2-Sided|95.0|-7.7|4.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621404|NCT02307682|2978240|Other||Difference in proportions|-4.5|||||2-Sided|95.0|-10.0|1.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621405|NCT02307682|2978240|Other||Difference in proportions|1.7|||||2-Sided|95.0|-4.1|7.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621406|NCT02307682|2978240|Other||Difference in proportions|-2.0|||||2-Sided|95.0|-7.9|3.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621407|NCT02307682|2978241|Other||Difference in proportions|-11.1|||||2-Sided|95.0|-16.4|-6.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621408|NCT02307682|2978241|Other||Difference in proportions|-5.5|||||2-Sided|95.0|-11.4|-0.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621409|NCT02307682|2978241|Other||Difference in proportions|-5.0|||||2-Sided|95.0|-9.7|-0.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621410|NCT02307682|2978241|Other||Difference in proportions|1.1|||||2-Sided|95.0|-4.0|6.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621411|NCT02307682|2978241|Other||Difference in proportions|-11.7|||||2-Sided|95.0|-17.3|-6.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621412|NCT02307682|2978241|Other||Difference in proportions|-5.7|||||2-Sided|95.0|-11.7|0.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621413|NCT02307682|2978241|Other||Difference in proportions|-5.1|||||2-Sided|95.0|-10.0|0.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621414|NCT02307682|2978241|Other||Difference in proportions|-5.1|||||2-Sided|95.0|-10.1|0.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621415|NCT02307682|2978241|Other||Difference in proportions|-11.7|||||2-Sided|95.0|-17.0|-6.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621416|NCT02307682|2978241|Other||Difference in proportions|-6.1|||||2-Sided|95.0|-11.8|-0.1|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621417|NCT02307682|2978241|Other||Difference in proportions|-5.9|||||2-Sided|95.0|-11.4|-0.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621418|NCT02307682|2978241|Other||Difference in proportions|-1.4|||||2-Sided|95.0|-7.0|4.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621464|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|2.8|Standard Error of the Mean|6.05|||2-Sided|95.0|-9.1|14.7|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80|
1621419|NCT02307682|2978241|Other||Difference in proportions|-12.5|||||2-Sided|95.0|-18.2|-7.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621420|NCT02307682|2978241|Other||Difference in proportions|-7.5|||||2-Sided|95.0|-12.8|-1.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621421|NCT02307682|2978241|Other||Difference in proportions|-1.4|||||2-Sided|95.0|-6.7|3.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621422|NCT02307682|2978241|Other||Difference in proportions|2.7|||||2-Sided|95.0|-2.5|8.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621423|NCT02307682|2978241|Other||Difference in proportions|-12.0|||||2-Sided|95.0|-17.8|-6.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621424|NCT02307682|2978241|Other||Difference in proportions|-7.4|||||2-Sided|95.0|-13.1|-1.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621425|NCT02307682|2978241|Other||Difference in proportions|-8.5|||||2-Sided|95.0|-13.9|-3.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621426|NCT02307682|2978241|Other||Difference in proportions|-4.5|||||2-Sided|95.0|-9.9|0.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621427|NCT02307682|2978241|Other||Difference in proportions|-9.6|||||2-Sided|95.0|-16.0|-3.8|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621428|NCT02307682|2978241|Other||Difference in proportions|-6.9|||||2-Sided|95.0|-12.6|-0.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621429|NCT02307682|2978241|Other||Difference in proportions|-8.6|||||2-Sided|95.0|-13.7|-3.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621430|NCT02307682|2978241|Other||Difference in proportions|-2.6|||||2-Sided|95.0|-8.0|3.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621431|NCT02307682|2978241|Other||Difference in proportions|-15.6|||||2-Sided|95.0|-21.2|-9.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621432|NCT02307682|2978241|Other||Difference in proportions|-11.6|||||2-Sided|95.0|-17.8|-5.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621433|NCT02307682|2978241|Other||Difference in proportions|-3.1|||||2-Sided|95.0|-8.7|2.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621434|NCT02307682|2978241|Other||Difference in proportions|0.9|||||2-Sided|95.0|-5.1|6.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621435|NCT02307682|2978241|Other||Difference in proportions|-11.4|||||2-Sided|95.0|-17.7|-5.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621436|NCT02307682|2978241|Other||Difference in proportions|-5.6|||||2-Sided|95.0|-11.5|0.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621437|NCT02307682|2978241|Other||Difference in proportions|-10.3|||||2-Sided|95.0|-15.9|-4.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621438|NCT02307682|2978241|Other||Difference in proportions|-7.8|||||2-Sided|95.0|-13.2|-2.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621465|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-0.2|Standard Error of the Mean|6.13|||2-Sided|95.0|-12.2|11.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76|
1621439|NCT02307682|2978241|Other||Difference in proportions|-12.4|||||2-Sided|95.0|-19.3|-6.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621440|NCT02307682|2978241|Other||Difference in proportions|-7.7|||||2-Sided|95.0|-14.3|-1.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621441|NCT02307682|2978241|Other||Difference in proportions|-5.1|||||2-Sided|95.0|-11.2|0.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621442|NCT02307682|2978241|Other||Difference in proportions|-2.8|||||2-Sided|95.0|-8.7|3.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621443|NCT02307682|2978241|Other||Difference in proportions|-23.4|||||2-Sided|95.0|-29.7|-17.6|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621444|NCT02307682|2978241|Other||Difference in proportions|-12.7|||||2-Sided|95.0|-19.1|-6.0|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621445|NCT02307682|2978241|Other||Difference in proportions|2.1|||||2-Sided|95.0|-4.3|7.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621446|NCT02307682|2978241|Other||Difference in proportions|4.1|||||2-Sided|95.0|-2.0|9.9|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621447|NCT02307682|2978241|Other||Difference in proportions|-19.7|||||2-Sided|95.0|-25.8|-13.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621448|NCT02307682|2978241|Other||Difference in proportions|-10.4|||||2-Sided|95.0|-16.8|-3.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621449|NCT02307682|2978241|Other||Difference in proportions|-14.0|||||2-Sided|95.0|-18.9|-8.7|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621450|NCT02307682|2978241|Other||Difference in proportions|-8.1|||||2-Sided|95.0|-13.8|-2.4|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621451|NCT02307682|2978241|Other||Difference in proportions|-15.0|||||2-Sided|95.0|-20.9|-9.5|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621452|NCT02307682|2978241|Other||Difference in proportions|-8.4|||||2-Sided|95.0|-14.6|-2.2|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621453|NCT02307682|2978241|Other||Difference in proportions|-14.2|||||2-Sided|95.0|-21.3|-7.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621454|NCT02307682|2978241|Other||Difference in proportions|-9.4|||||2-Sided|95.0|-16.4|-3.3|||||Statistical model used logistic regression adjusting for baseline fluid status, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621455|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-3.9|Standard Error of the Mean|6.07|||2-Sided|95.0|-15.8|8.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96|
1621456|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-4.0|Standard Error of the Mean|5.91|||2-Sided|95.0|-15.6|7.6|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96|
1621457|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|0.9|Standard Error of the Mean|6.09|||2-Sided|95.0|-11.1|12.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92|
1621458|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|1.7|Standard Error of the Mean|5.87|||2-Sided|95.0|-9.8|13.3|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92|
1621459|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-0.8|Standard Error of the Mean|6.0|||2-Sided|95.0|-12.6|11.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88|
1621460|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-1.7|Standard Error of the Mean|5.86|||2-Sided|95.0|-13.2|9.8|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88|
1621461|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|6.04|||2-Sided|95.0|-12.0|11.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84|
1621467|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-1.8|Standard Error of the Mean|6.06|||2-Sided|95.0|-13.7|10.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72|
1621468|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-2.9|Standard Error of the Mean|5.91|||2-Sided|95.0|-14.5|8.7|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72|
1621469|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|2.1|Standard Error of the Mean|6.08|||2-Sided|95.0|-9.8|14.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68|
1621470|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|2.3|Standard Error of the Mean|5.91|||2-Sided|95.0|-9.3|13.9|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68|
1621471|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-0.2|Standard Error of the Mean|6.09|||2-Sided|95.0|-12.2|11.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64|
1621472|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-0.2|Standard Error of the Mean|5.87|||2-Sided|95.0|-11.7|11.3|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64|
1621473|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|2.4|Standard Error of the Mean|6.17|||2-Sided|95.0|-9.7|14.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60|
1621474|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-0.4|Standard Error of the Mean|5.89|||2-Sided|95.0|-11.9|11.2|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60|
1621475|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|1.6|Standard Error of the Mean|6.08|||2-Sided|95.0|-10.4|13.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56|
1621476|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|0.9|Standard Error of the Mean|5.87|||2-Sided|95.0|-10.6|12.4|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56|
1621477|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|1.2|Standard Error of the Mean|6.04|||2-Sided|95.0|-10.6|13.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52|
1621478|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|1.9|Standard Error of the Mean|5.77|||2-Sided|95.0|-9.5|13.2|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52|
1621479|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-0.6|Standard Error of the Mean|5.93|||2-Sided|95.0|-12.2|11.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48|
1621480|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|0.8|Standard Error of the Mean|5.76|||2-Sided|95.0|-10.5|12.1|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48|
1621481|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|1.5|Standard Error of the Mean|5.87|||2-Sided|95.0|-10.0|13.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44|
1621482|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|4.9|Standard Error of the Mean|5.62|||2-Sided|95.0|-6.1|15.9|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44|
1621483|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-3.6|Standard Error of the Mean|5.83|||2-Sided|95.0|-15.0|7.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40|
1621484|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|0.5|Standard Error of the Mean|5.71|||2-Sided|95.0|-10.7|11.7|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40|
1621485|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-0.6|Standard Error of the Mean|5.89|||2-Sided|95.0|-12.2|10.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36|
1621486|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|2.4|Standard Error of the Mean|5.7|||2-Sided|95.0|-8.8|13.6|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36|
1621487|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|5.92|||2-Sided|95.0|-11.7|11.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32|
1621488|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|2.9|Standard Error of the Mean|5.73|||2-Sided|95.0|-8.4|14.1|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32|
1621489|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|2.6|Standard Error of the Mean|5.73|||2-Sided|95.0|-8.7|13.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28|
1621490|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|2.1|Standard Error of the Mean|5.51|||2-Sided|95.0|-8.8|12.9|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28|
1621491|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-6.3|Standard Error of the Mean|5.92|||2-Sided|95.0|-17.9|5.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24|
1621492|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-3.6|Standard Error of the Mean|5.68|||2-Sided|95.0|-14.7|7.6|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24|
1621493|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|7.6|Standard Error of the Mean|5.58|||2-Sided|95.0|-3.4|18.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20|
1621494|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|9.3|Standard Error of the Mean|5.56|||2-Sided|95.0|-1.6|20.3|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20|
1621495|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-4.8|Standard Error of the Mean|5.76|||2-Sided|95.0|-16.1|6.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16|
1621496|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|0.2|Standard Error of the Mean|5.73|||2-Sided|95.0|-11.1|11.4|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16|
1622114|NCT02301897|2978577|Superiority|||||||0.0772|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1621498|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-0.6|Standard Error of the Mean|5.38|||2-Sided|95.0|-11.2|10.0|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12|
1621499|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|-1.6|Standard Error of the Mean|5.52|||2-Sided|95.0|-12.5|9.2|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8|
1621500|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|2.1|Standard Error of the Mean|5.35|||2-Sided|95.0|-8.4|12.6|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8|
1621501|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|0.3|Standard Error of the Mean|5.37|||2-Sided|95.0|-10.2|10.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4|
1621502|NCT02307682|2978242|Other|Treatment difference|Least Squares Mean Difference|7.1|Standard Error of the Mean|5.31|||2-Sided|95.0|-3.3|17.5|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4|
1621503|NCT02307682|2978243|Other|Treatment difference|Least Squares Mean Difference|-0.7|Standard Error of the Mean|0.23|||2-Sided|95.0|-1.1|-0.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96|
1621504|NCT02307682|2978243|Other|Treatment difference|Least Squares Mean Difference|-0.8|Standard Error of the Mean|0.26|||2-Sided|95.0|-1.3|-0.3|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96|
1621505|NCT02307682|2978243|Other|Treatment difference|Least Squares Mean Difference|-0.5|Standard Error of the Mean|0.22|||2-Sided|95.0|-0.9|0.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48|
1621506|NCT02307682|2978243|Other|Treatment difference|Least Squares Mean Difference|-0.7|Standard Error of the Mean|0.24|||2-Sided|95.0|-1.1|-0.2|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48|
1621507|NCT02307682|2978243|Other|Treatment difference|Least Squares Mean Difference|-0.6|Standard Error of the Mean|0.2|||2-Sided|95.0|-1.0|-0.2|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12|
1621508|NCT02307682|2978243|Other|Treatment difference|Least Squares Mean Difference|-0.3|Standard Error of the Mean|0.23|||2-Sided|95.0|-0.8|0.1|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12|
1621509|NCT02307682|2978244|Other|Treatment difference|Least Squares Mean Difference|-19.3|Standard Error of the Mean|8.93|||2-Sided|95.0|-36.9|-1.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96|
1621510|NCT02307682|2978244|Other|Treatment difference|Least Squares Mean Difference|-18.9|Standard Error of the Mean|8.87|||2-Sided|95.0|-36.4|-1.5|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 96|
1621511|NCT02307682|2978244|Other|Treatment difference|Least Squares Mean Difference|-19.9|Standard Error of the Mean|8.45|||2-Sided|95.0|-36.5|-3.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48|
1621512|NCT02307682|2978244|Other|Treatment difference|Least Squares Mean Difference|-16.0|Standard Error of the Mean|8.5|||2-Sided|95.0|-32.6|0.7|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 48|
1621513|NCT02307682|2978245|Other|Treatment difference|Least Squares Mean Difference|-18.6|Standard Error of the Mean|10.0|||2-Sided|95.0|-38.3|1.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)||
1621514|NCT02307682|2978245|Other|Treatment difference|Least Squares Mean Difference|-23.2|Standard Error of the Mean|9.76|||2-Sided|95.0|-42.4|-4.1|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)||
1621515|NCT02307682|2978246|Superiority||Least Squares Mean Difference|-22.4|Standard Error of the Mean|9.19||0.0075|2-Sided|95.0|-40.4|-4.4||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)||
1621516|NCT02307682|2978246|Superiority||Least Squares Mean Difference|-19.5|Standard Error of the Mean|9.29||0.0183|2-Sided|95.0|-37.7|-1.2||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)||
1621517|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-26.0|Standard Error of the Mean|10.28|||2-Sided|95.0|-46.2|-5.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96|
1621518|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-30.9|Standard Error of the Mean|10.0|||2-Sided|95.0|-50.6|-11.3|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96|
1621519|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-12.5|Standard Error of the Mean|9.99|||2-Sided|95.0|-32.1|7.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92|
1621520|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-15.1|Standard Error of the Mean|9.7|||2-Sided|95.0|-34.2|3.9|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92|
1621521|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-24.2|Standard Error of the Mean|10.22|||2-Sided|95.0|-44.3|-4.2|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88|
1621522|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-27.3|Standard Error of the Mean|10.16|||2-Sided|95.0|-47.3|-7.4|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88|
1621523|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-11.8|Standard Error of the Mean|10.05|||2-Sided|95.0|-31.5|8.0|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84|
1621524|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-19.5|Standard Error of the Mean|9.65|||2-Sided|95.0|-38.4|-0.5|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84|
1621525|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-23.7|Standard Error of the Mean|10.32|||2-Sided|95.0|-43.9|-3.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80|
1621526|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-24.8|Standard Error of the Mean|10.34|||2-Sided|95.0|-45.0|-4.5|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80|
1622115|NCT02301897|2978577|Superiority|||||||0.401|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1621527|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-15.7|Standard Error of the Mean|9.84|||2-Sided|95.0|-35.0|3.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76|
1621528|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-19.3|Standard Error of the Mean|9.62|||2-Sided|95.0|-38.2|-0.4|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76|
1621529|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-26.4|Standard Error of the Mean|9.99|||2-Sided|95.0|-46.0|-6.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72|
1621530|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-29.9|Standard Error of the Mean|9.89|||2-Sided|95.0|-49.3|-10.5|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72|
1621531|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-13.2|Standard Error of the Mean|9.88|||2-Sided|95.0|-32.6|6.2|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68|
1621532|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-14.9|Standard Error of the Mean|9.6|||2-Sided|95.0|-33.8|3.9|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68|
1621533|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-22.5|Standard Error of the Mean|9.73|||2-Sided|95.0|-41.6|-3.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64|
1621534|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-27.2|Standard Error of the Mean|9.96|||2-Sided|95.0|-46.7|-7.6|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64|
1621535|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-12.7|Standard Error of the Mean|9.56|||2-Sided|95.0|-31.4|6.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60|
1621536|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-18.8|Standard Error of the Mean|9.3|||2-Sided|95.0|-37.0|-0.5|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60|
1621537|NCT02307682|2978247|Other||Least Squares Mean Difference|-20.0|Standard Error of the Mean|9.86|||2-Sided|95.0|-39.4|-0.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56|
1621538|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-20.0|Standard Error of the Mean|9.62|||2-Sided|95.0|-38.9|-1.1|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56|
1621539|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-15.1|Standard Error of the Mean|9.35|||2-Sided|95.0|-33.4|3.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52|
1621540|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-15.6|Standard Error of the Mean|9.17|||2-Sided|95.0|-33.6|2.4|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52|
1621541|NCT02307682|2978247|Superiority||Least Squares Mean Difference|-29.0|Standard Error of the Mean|9.47||0.0012|2-Sided|95.0|-47.6|-10.4||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48|
1621542|NCT02307682|2978247|Superiority||Least Squares Mean Difference|-23.9|Standard Error of the Mean|9.79||0.0075|2-Sided|95.0|-43.1|-4.6||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48|
1621543|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-11.4|Standard Error of the Mean|9.64|||2-Sided|95.0|-30.3|7.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44|
1621544|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-9.3|Standard Error of the Mean|9.27|||2-Sided|95.0|-27.5|8.9|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44|
1621545|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-29.5|Standard Error of the Mean|9.5|||2-Sided|95.0|-48.2|-10.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40|
1621546|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-27.3|Standard Error of the Mean|9.83|||2-Sided|95.0|-46.6|-8.0|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40|
1621547|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-19.6|Standard Error of the Mean|9.14|||2-Sided|95.0|-37.6|-1.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36|
1621548|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-17.4|Standard Error of the Mean|9.24|||2-Sided|95.0|-35.5|0.7|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36|
1621549|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-23.2|Standard Error of the Mean|9.64|||2-Sided|95.0|-42.1|-4.2|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32|
1621550|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-20.1|Standard Error of the Mean|9.91|||2-Sided|95.0|-39.6|-0.7|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32|
1621551|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-12.1|Standard Error of the Mean|8.98|||2-Sided|95.0|-29.8|5.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28|
1621552|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-11.6|Standard Error of the Mean|8.96|||2-Sided|95.0|-29.2|5.9|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28|
1621553|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-29.6|Standard Error of the Mean|9.13|||2-Sided|95.0|-47.5|-11.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24|
1621554|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-25.8|Standard Error of the Mean|9.44|||2-Sided|95.0|-44.3|-7.2|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24|
1621555|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|3.2|Standard Error of the Mean|8.8|||2-Sided|95.0|-14.1|20.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20|
1621556|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|5.2|Standard Error of the Mean|8.69|||2-Sided|95.0|-11.8|22.3|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20|
1621557|NCT02307682|2978247|Superiority||Least Squares Mean Difference|-27.8|Standard Error of the Mean|8.8||0.0008|2-Sided|95.0|-45.1|-10.5||1-sided testing for superiority of brolucizumab 6 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16|
1621558|NCT02307682|2978247|Superiority||Least Squares Mean Difference|-19.9|Standard Error of the Mean|9.24||0.0159|2-Sided|95.0|-38.0|-1.7||1-sided testing for superiority of brolucizumab 3 mg versus aflibercept 2 mg|ANOVA|Analyzed using ANOVA model with baseline CSFT-total categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16|
1621559|NCT02307682|2978247|Other||Least Squares Mean Difference|-24.5|Standard Error of the Mean|8.24|||2-Sided|95.0|-40.7|-8.3|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12|
1621560|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-19.7|Standard Error of the Mean|8.45|||2-Sided|95.0|-36.3|-3.1|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12|
1621561|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-19.0|Standard Error of the Mean|8.16|||2-Sided|95.0|-35.0|-2.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8|
1621562|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-13.7|Standard Error of the Mean|8.51|||2-Sided|95.0|-30.4|3.0|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8|
1621563|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-16.5|Standard Error of the Mean|7.86|||2-Sided|95.0|-31.9|-1.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4|
1621564|NCT02307682|2978247|Other|Treatment difference|Least Squares Mean Difference|-7.9|Standard Error of the Mean|8.3|||2-Sided|95.0|-24.2|8.4|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4|
1621565|NCT02307682|2978248|Other||Difference in proportions|2.3|||||2-Sided|95.0|-3.8|9.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621566|NCT02307682|2978248|Other||Difference in proportions|1.7|||||2-Sided|95.0|-4.7|7.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621567|NCT02307682|2978248|Other||Difference in proportions|1.8|||||2-Sided|95.0|-4.3|8.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621568|NCT02307682|2978248|Other||Difference in proportions|3.8|||||2-Sided|95.0|-2.8|9.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621569|NCT02307682|2978248|Other||Difference in proportions|-0.1|||||2-Sided|95.0|-6.0|6.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621570|NCT02307682|2978248|Other||Difference in proportions|0.0|||||2-Sided|95.0|-6.6|6.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621571|NCT02307682|2978248|Other||Difference in proportions|0.2|||||2-Sided|95.0|-5.8|6.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621572|NCT02307682|2978248|Other||Difference in proportions|3.3|||||2-Sided|95.0|-3.0|9.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621573|NCT02307682|2978248|Other||Difference in proportions|2.4|||||2-Sided|95.0|-3.5|9.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621574|NCT02307682|2978248|Other||Difference in proportions|3.9|||||2-Sided|95.0|-2.5|9.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621575|NCT02307682|2978248|Other||Difference in proportions|1.2|||||2-Sided|95.0|-5.1|7.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621576|NCT02307682|2978248|Other||Difference in proportions|4.0|||||2-Sided|95.0|-2.4|10.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621577|NCT02307682|2978248|Other||Difference in proportions|-2.1|||||2-Sided|95.0|-8.5|4.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621578|NCT02307682|2978248|Other||Difference in proportions|-0.4|||||2-Sided|95.0|-7.2|5.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621579|NCT02307682|2978248|Other||Difference in proportions|-0.1|||||2-Sided|95.0|-6.3|6.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621580|NCT02307682|2978248|Other||Difference in proportions|2.0|||||2-Sided|95.0|-4.3|8.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621581|NCT02307682|2978248|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-6.6|5.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621582|NCT02307682|2978248|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-7.2|5.5||||||Week 64|
1621583|NCT02307682|2978248|Other||Difference in proportions|-3.0|||||2-Sided|95.0|-9.0|3.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621584|NCT02307682|2978248|Other||Difference in proportions|0.6|||||2-Sided|95.0|-5.7|6.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621585|NCT02307682|2978248|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-6.6|6.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621586|NCT02307682|2978248|Other||Difference in proportions|0.2|||||2-Sided|95.0|-5.9|6.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621587|NCT02307682|2978248|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-6.8|6.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621588|NCT02307682|2978248|Other||Difference in proportions|-2.4|||||2-Sided|95.0|-8.8|3.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621589|NCT02307682|2978248|Other||Difference in proportions|-2.4|||||2-Sided|95.0|-8.6|3.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621590|NCT02307682|2978248|Other||Difference in proportions|-3.5|||||2-Sided|95.0|-9.5|2.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621591|NCT02307682|2978248|Other||Difference in proportions|-2.2|||||2-Sided|95.0|-8.4|4.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621592|NCT02307682|2978248|Other||Difference in proportions|-2.4|||||2-Sided|95.0|-8.8|3.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621593|NCT02307682|2978248|Other||Difference in proportions|-1.2|||||2-Sided|95.0|-7.4|5.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621594|NCT02307682|2978248|Other||Difference in proportions|1.0|||||2-Sided|95.0|-5.2|6.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621595|NCT02307682|2978248|Other||Difference in proportions|0.4|||||2-Sided|95.0|-6.0|6.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621596|NCT02307682|2978248|Other||Difference in proportions|-2.4|||||2-Sided|95.0|-8.5|3.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621597|NCT02307682|2978248|Other||Difference in proportions|5.1|||||2-Sided|95.0|-1.0|11.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621598|NCT02307682|2978248|Other||Difference in proportions|1.6|||||2-Sided|95.0|-3.9|7.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621599|NCT02307682|2978248|Other||Difference in proportions|1.1|||||2-Sided|95.0|-4.9|7.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621921|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.0|Standard Error of the Mean|1.06|||2-Sided|95.0|-2.1|2.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 76|
1621600|NCT02307682|2978248|Other||Difference in proportions|-0.1|||||2-Sided|95.0|-6.5|5.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621601|NCT02307682|2978248|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-6.6|5.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621602|NCT02307682|2978248|Other||Difference in proportions|1.1|||||2-Sided|95.0|-4.6|6.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621603|NCT02307682|2978248|Other||Difference in proportions|-3.4|||||2-Sided|95.0|-9.4|2.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621604|NCT02307682|2978248|Other||Difference in proportions|-4.0|||||2-Sided|95.0|-10.4|2.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621605|NCT02307682|2978248|Other||Difference in proportions|0.1|||||2-Sided|95.0|-6.2|6.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621606|NCT02307682|2978248|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-6.3|5.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621607|NCT02307682|2978248|Other||Difference in proportions|-4.0|||||2-Sided|95.0|-10.0|2.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621608|NCT02307682|2978248|Other||Difference in proportions|-3.1|||||2-Sided|95.0|-8.9|2.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621609|NCT02307682|2978248|Other||Difference in proportions|-2.1|||||2-Sided|95.0|-7.7|3.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621610|NCT02307682|2978248|Other||Difference in proportions|-3.0|||||2-Sided|95.0|-8.9|2.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621611|NCT02307682|2978248|Other||Difference in proportions|-2.7|||||2-Sided|95.0|-8.5|2.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621612|NCT02307682|2978248|Other||Difference in proportions|-2.1|||||2-Sided|95.0|-7.7|3.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621613|NCT02307682|2978249|Other||Difference in proportions|1.6|||||2-Sided|95.0|-4.7|7.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621614|NCT02307682|2978249|Other||Difference in proportions|2.8|||||2-Sided|95.0|-3.1|8.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621615|NCT02307682|2978249|Other||Difference in proportions|1.4|||||2-Sided|95.0|-4.5|6.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621616|NCT02307682|2978249|Other||Difference in proportions|1.3|||||2-Sided|95.0|-4.5|6.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621617|NCT02307682|2978249|Other||Difference in proportions|1.4|||||2-Sided|95.0|-4.6|6.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621618|NCT02307682|2978249|Other||Difference in proportions|0.9|||||2-Sided|95.0|-4.5|6.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621619|NCT02307682|2978249|Other||Difference in proportions|3.3|||||2-Sided|95.0|-2.9|8.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621620|NCT02307682|2978249|Other||Difference in proportions|2.2|||||2-Sided|95.0|-3.1|7.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621621|NCT02307682|2978249|Other||Difference in proportions|1.1|||||2-Sided|95.0|-4.8|6.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621622|NCT02307682|2978249|Other||Difference in proportions|0.7|||||2-Sided|95.0|-4.8|6.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621623|NCT02307682|2978249|Other||Difference in proportions|1.2|||||2-Sided|95.0|-4.7|6.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621624|NCT02307682|2978249|Other||Difference in proportions|0.9|||||2-Sided|95.0|-4.6|6.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621625|NCT02307682|2978249|Other||Difference in proportions|0.5|||||2-Sided|95.0|-5.2|5.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621626|NCT02307682|2978249|Other||Difference in proportions|1.2|||||2-Sided|95.0|-4.3|6.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621627|NCT02307682|2978249|Other||Difference in proportions|0.5|||||2-Sided|95.0|-5.1|5.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621628|NCT02307682|2978249|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-5.5|4.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621629|NCT02307682|2978249|Other||Difference in proportions|2.9|||||2-Sided|95.0|-2.8|7.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621630|NCT02307682|2978249|Other||Difference in proportions|2.2|||||2-Sided|95.0|-2.9|7.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621631|NCT02307682|2978249|Other||Difference in proportions|1.7|||||2-Sided|95.0|-3.8|6.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621632|NCT02307682|2978249|Other||Difference in proportions|0.4|||||2-Sided|95.0|-4.5|5.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621633|NCT02307682|2978249|Other||Difference in proportions|1.5|||||2-Sided|95.0|-3.8|6.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621634|NCT02307682|2978249|Other||Difference in proportions|0.9|||||2-Sided|95.0|-4.0|6.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621635|NCT02307682|2978249|Other||Difference in proportions|1.6|||||2-Sided|95.0|-3.9|6.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621636|NCT02307682|2978249|Other||Difference in proportions|0.2|||||2-Sided|95.0|-4.6|5.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621637|NCT02307682|2978249|Other||Difference in proportions|0.8|||||2-Sided|95.0|-4.3|5.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621638|NCT02307682|2978249|Other||Difference in proportions|2.1|||||2-Sided|95.0|-2.7|6.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621639|NCT02307682|2978249|Other||Difference in proportions|-1.6|||||2-Sided|95.0|-6.5|3.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621640|NCT02307682|2978249|Other||Difference in proportions|-0.7|||||2-Sided|95.0|-5.7|4.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621641|NCT02307682|2978249|Other||Difference in proportions|0.4|||||2-Sided|95.0|-4.7|4.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621642|NCT02307682|2978249|Other||Difference in proportions|-1.1|||||2-Sided|95.0|-5.9|4.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621643|NCT02307682|2978249|Other||Difference in proportions|2.1|||||2-Sided|95.0|-2.7|6.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621644|NCT02307682|2978249|Other||Difference in proportions|2.8|||||2-Sided|95.0|-1.8|7.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621645|NCT02307682|2978249|Other||Difference in proportions|-1.1|||||2-Sided|95.0|-6.1|4.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621646|NCT02307682|2978249|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-5.0|4.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621647|NCT02307682|2978249|Other||Difference in proportions|0.8|||||2-Sided|95.0|-4.7|5.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621648|NCT02307682|2978249|Other||Difference in proportions|-2.3|||||2-Sided|95.0|-6.8|2.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621649|NCT02307682|2978249|Other||Difference in proportions|3.8|||||2-Sided|95.0|-1.4|8.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621650|NCT02307682|2978249|Other||Difference in proportions|-0.8|||||2-Sided|95.0|-5.2|3.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621651|NCT02307682|2978249|Other||Difference in proportions|2.0|||||2-Sided|95.0|-2.9|6.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621652|NCT02307682|2978249|Other||Difference in proportions|-1.3|||||2-Sided|95.0|-5.4|3.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621653|NCT02307682|2978249|Other||Difference in proportions|-1.6|||||2-Sided|95.0|-6.2|3.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621654|NCT02307682|2978249|Other||Difference in proportions|-0.7|||||2-Sided|95.0|-5.4|4.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621655|NCT02307682|2978249|Other||Difference in proportions|3.4|||||2-Sided|95.0|-0.9|7.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621656|NCT02307682|2978249|Other||Difference in proportions|1.8|||||2-Sided|95.0|-2.3|6.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621657|NCT02307682|2978249|Other||Difference in proportions|2.7|||||2-Sided|95.0|-1.7|6.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621658|NCT02307682|2978249|Other||Difference in proportions|-0.2|||||2-Sided|95.0|-4.1|3.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621659|NCT02307682|2978249|Other||Difference in proportions|2.4|||||2-Sided|95.0|-1.8|6.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621660|NCT02307682|2978249|Other||Difference in proportions|1.6|||||2-Sided|95.0|-2.4|5.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621661|NCT02307682|2978250|Other||Difference in proportions|2.1|||||2-Sided|95.0|-3.4|7.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621662|NCT02307682|2978250|Other||Difference in proportions|-0.8|||||2-Sided|95.0|-5.7|4.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621663|NCT02307682|2978250|Other||Difference in proportions|-0.2|||||2-Sided|95.0|-5.3|4.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621664|NCT02307682|2978250|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-5.5|4.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621665|NCT02307682|2978250|Other||Difference in proportions|0.1|||||2-Sided|95.0|-5.2|4.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621666|NCT02307682|2978250|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-5.8|4.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621667|NCT02307682|2978250|Other||Difference in proportions|1.9|||||2-Sided|95.0|-3.2|6.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621668|NCT02307682|2978250|Other||Difference in proportions|0.5|||||2-Sided|95.0|-4.2|5.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621669|NCT02307682|2978250|Other||Difference in proportions|1.7|||||2-Sided|95.0|-3.2|6.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621670|NCT02307682|2978250|Other||Difference in proportions|-1.2|||||2-Sided|95.0|-5.8|3.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621671|NCT02307682|2978250|Other||Difference in proportions|2.3|||||2-Sided|95.0|-2.9|6.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621672|NCT02307682|2978250|Other||Difference in proportions|-1.1|||||2-Sided|95.0|-5.6|3.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621673|NCT02307682|2978250|Other||Difference in proportions|-0.9|||||2-Sided|95.0|-6.1|3.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621674|NCT02307682|2978250|Other||Difference in proportions|-1.9|||||2-Sided|95.0|-6.6|2.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621675|NCT02307682|2978250|Other||Difference in proportions|2.3|||||2-Sided|95.0|-2.8|6.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621676|NCT02307682|2978250|Other||Difference in proportions|1.1|||||2-Sided|95.0|-3.4|5.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621677|NCT02307682|2978250|Other||Difference in proportions|2.0|||||2-Sided|95.0|-2.8|6.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621678|NCT02307682|2978250|Other||Difference in proportions|1.4|||||2-Sided|95.0|-3.1|5.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621679|NCT02307682|2978250|Other||Difference in proportions|1.2|||||2-Sided|95.0|-3.8|5.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621680|NCT02307682|2978250|Other||Difference in proportions|-0.4|||||2-Sided|95.0|-4.8|3.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621681|NCT02307682|2978250|Other||Difference in proportions|2.5|||||2-Sided|95.0|-2.2|6.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621682|NCT02307682|2978250|Other||Difference in proportions|2.0|||||2-Sided|95.0|-2.3|6.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621683|NCT02307682|2978250|Other||Difference in proportions|3.0|||||2-Sided|95.0|-1.6|7.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621684|NCT02307682|2978250|Other||Difference in proportions|0.6|||||2-Sided|95.0|-3.5|4.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621685|NCT02307682|2978250|Other||Difference in proportions|1.3|||||2-Sided|95.0|-2.9|5.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621686|NCT02307682|2978250|Other||Difference in proportions|1.9|||||2-Sided|95.0|-2.2|6.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621687|NCT02307682|2978250|Other||Difference in proportions|0.7|||||2-Sided|95.0|-3.7|4.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621688|NCT02307682|2978250|Other||Difference in proportions|0.6|||||2-Sided|95.0|-3.7|4.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621689|NCT02307682|2978250|Other||Difference in proportions|0.8|||||2-Sided|95.0|-3.6|4.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621690|NCT02307682|2978250|Other||Difference in proportions|-0.2|||||2-Sided|95.0|-4.3|3.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621691|NCT02307682|2978250|Other||Difference in proportions|1.9|||||2-Sided|95.0|-2.1|5.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621692|NCT02307682|2978250|Other||Difference in proportions|1.2|||||2-Sided|95.0|-2.6|5.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621693|NCT02307682|2978250|Other||Difference in proportions|0.6|||||2-Sided|95.0|-3.2|4.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621694|NCT02307682|2978250|Other||Difference in proportions|0.6|||||2-Sided|95.0|-3.2|4.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621695|NCT02307682|2978250|Other||Difference in proportions|0.6|||||2-Sided|95.0|-3.6|4.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621696|NCT02307682|2978250|Other||Difference in proportions|0.5|||||2-Sided|95.0|-3.5|4.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621697|NCT02307682|2978250|Other||Difference in proportions|2.3|||||2-Sided|95.0|-1.8|6.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621698|NCT02307682|2978250|Other||Difference in proportions|-0.5|||||2-Sided|95.0|-3.9|3.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621699|NCT02307682|2978250|Other||Difference in proportions|1.1|||||2-Sided|95.0|-2.3|4.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621700|NCT02307682|2978250|Other||Difference in proportions|-0.9|||||2-Sided|95.0|-4.1|2.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621701|NCT02307682|2978250|Other||Difference in proportions|-1.5|||||2-Sided|95.0|-5.0|2.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621702|NCT02307682|2978250|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-4.2|2.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621703|NCT02307682|2978250|Other||Difference in proportions|0.1|||||2-Sided|95.0|-3.5|3.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621704|NCT02307682|2978250|Other||Difference in proportions|-1.2|||||2-Sided|95.0|-4.6|2.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621705|NCT02307682|2978250|Other||Difference in proportions|0.0|||||2-Sided|95.0|-3.0|2.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621706|NCT02307682|2978250|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-3.3|2.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621707|NCT02307682|2978250|Other||Difference in proportions|0.3|||||2-Sided|95.0|-2.6|3.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621708|NCT02307682|2978250|Other||Difference in proportions|-0.7|||||2-Sided|95.0|-3.7|2.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621709|NCT02307682|2978251|Other||Difference in proportions|0.7|||||2-Sided|95.0|-3.6|4.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621710|NCT02307682|2978251|Other||Difference in proportions|1.1|||||2-Sided|95.0|-2.9|4.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621711|NCT02307682|2978251|Other||Difference in proportions|1.2|||||2-Sided|95.0|-3.0|5.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621712|NCT02307682|2978251|Other||Difference in proportions|1.7|||||2-Sided|95.0|-2.2|5.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621713|NCT02307682|2978251|Other||Difference in proportions|0.1|||||2-Sided|95.0|-4.1|4.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621714|NCT02307682|2978251|Other||Difference in proportions|0.6|||||2-Sided|95.0|-3.7|4.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621715|NCT02307682|2978251|Other||Difference in proportions|0.6|||||2-Sided|95.0|-3.7|4.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621716|NCT02307682|2978251|Other||Difference in proportions|1.4|||||2-Sided|95.0|-2.6|5.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621717|NCT02307682|2978251|Other||Difference in proportions|-0.2|||||2-Sided|95.0|-4.6|3.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621718|NCT02307682|2978251|Other||Difference in proportions|-0.8|||||2-Sided|95.0|-4.8|3.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621719|NCT02307682|2978251|Other||Difference in proportions|2.0|||||2-Sided|95.0|-2.1|6.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621720|NCT02307682|2978251|Other||Difference in proportions|0.6|||||2-Sided|95.0|-3.1|4.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621721|NCT02307682|2978251|Other||Difference in proportions|1.5|||||2-Sided|95.0|-2.7|5.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621722|NCT02307682|2978251|Other||Difference in proportions|1.2|||||2-Sided|95.0|-2.6|4.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621723|NCT02307682|2978251|Other||Difference in proportions|1.1|||||2-Sided|95.0|-2.9|4.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621724|NCT02307682|2978251|Other||Difference in proportions|0.8|||||2-Sided|95.0|-3.1|4.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621725|NCT02307682|2978251|Other||Difference in proportions|2.8|||||2-Sided|95.0|-1.3|6.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621726|NCT02307682|2978251|Other||Difference in proportions|1.5|||||2-Sided|95.0|-2.4|5.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621727|NCT02307682|2978251|Other||Difference in proportions|1.2|||||2-Sided|95.0|-2.9|4.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621728|NCT02307682|2978251|Other||Difference in proportions|0.1|||||2-Sided|95.0|-3.5|3.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621729|NCT02307682|2978251|Other||Difference in proportions|2.6|||||2-Sided|95.0|-1.5|6.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621730|NCT02307682|2978251|Other||Difference in proportions|1.1|||||2-Sided|95.0|-2.4|4.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621731|NCT02307682|2978251|Other||Difference in proportions|1.3|||||2-Sided|95.0|-2.5|4.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621732|NCT02307682|2978251|Other||Difference in proportions|0.3|||||2-Sided|95.0|-3.3|4.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621733|NCT02307682|2978251|Other||Difference in proportions|0.9|||||2-Sided|95.0|-2.7|4.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621734|NCT02307682|2978251|Other||Difference in proportions|0.3|||||2-Sided|95.0|-3.2|3.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621735|NCT02307682|2978251|Other||Difference in proportions|2.0|||||2-Sided|95.0|-1.4|5.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621736|NCT02307682|2978251|Other||Difference in proportions|1.1|||||2-Sided|95.0|-2.2|4.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621737|NCT02307682|2978251|Other||Difference in proportions|2.8|||||2-Sided|95.0|-0.7|6.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621738|NCT02307682|2978251|Other||Difference in proportions|0.9|||||2-Sided|95.0|-2.1|3.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621739|NCT02307682|2978251|Other||Difference in proportions|3.1|||||2-Sided|95.0|0.0|6.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621740|NCT02307682|2978251|Other||Difference in proportions|1.4|||||2-Sided|95.0|-1.5|4.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621741|NCT02307682|2978251|Other||Difference in proportions|2.2|||||2-Sided|95.0|-1.0|5.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621742|NCT02307682|2978251|Other||Difference in proportions|1.0|||||2-Sided|95.0|-2.0|4.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621743|NCT02307682|2978251|Other||Difference in proportions|1.1|||||2-Sided|95.0|-2.3|4.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621744|NCT02307682|2978251|Other||Difference in proportions|0.2|||||2-Sided|95.0|-2.9|3.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621745|NCT02307682|2978251|Other||Difference in proportions|1.5|||||2-Sided|95.0|-1.8|4.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621746|NCT02307682|2978251|Other||Difference in proportions|0.3|||||2-Sided|95.0|-2.6|3.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621747|NCT02307682|2978251|Other||Difference in proportions|2.3|||||2-Sided|95.0|-0.3|5.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621748|NCT02307682|2978251|Other||Difference in proportions|0.0|||||2-Sided|95.0|-2.2|2.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621749|NCT02307682|2978251|Other||Difference in proportions|0.3|||||2-Sided|95.0|-2.4|3.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621750|NCT02307682|2978251|Other||Difference in proportions|-0.3|||||2-Sided|95.0|-3.0|2.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621751|NCT02307682|2978251|Other||Difference in proportions|-0.3|||||2-Sided|95.0|-3.2|2.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621752|NCT02307682|2978251|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-3.3|2.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621753|NCT02307682|2978251|Other||Difference in proportions|0.7|||||2-Sided|95.0|-1.7|2.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621754|NCT02307682|2978251|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-2.6|1.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621755|NCT02307682|2978251|Other||Difference in proportions|1.7|||||2-Sided|95.0|-0.5|4.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621756|NCT02307682|2978251|Other||Difference in proportions|0.4|||||2-Sided|95.0|-1.4|2.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621757|NCT02307682|2978252|Other||Difference in proportions|0.6|||||2-Sided|95.0|-6.6|8.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621758|NCT02307682|2978252|Other||Difference in proportions|4.6|||||2-Sided|95.0|-2.9|11.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621759|NCT02307682|2978252|Other||Difference in proportions|-2.1|||||2-Sided|95.0|-9.1|5.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621760|NCT02307682|2978252|Other||Difference in proportions|-0.4|||||2-Sided|95.0|-7.9|6.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621761|NCT02307682|2978252|Other||Difference in proportions|-2.5|||||2-Sided|95.0|-9.7|4.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621762|NCT02307682|2978252|Other||Difference in proportions|-1.2|||||2-Sided|95.0|-8.5|5.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621763|NCT02307682|2978252|Other||Difference in proportions|1.3|||||2-Sided|95.0|-5.9|8.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621764|NCT02307682|2978252|Other||Difference in proportions|1.9|||||2-Sided|95.0|-5.1|8.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621765|NCT02307682|2978252|Other||Difference in proportions|0.8|||||2-Sided|95.0|-6.1|8.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621766|NCT02307682|2978252|Other||Difference in proportions|3.2|||||2-Sided|95.0|-3.9|10.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621767|NCT02307682|2978252|Other||Difference in proportions|1.9|||||2-Sided|95.0|-5.0|8.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621768|NCT02307682|2978252|Other||Difference in proportions|2.4|||||2-Sided|95.0|-5.1|9.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621769|NCT02307682|2978252|Other||Difference in proportions|1.7|||||2-Sided|95.0|-5.5|9.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621770|NCT02307682|2978252|Other||Difference in proportions|1.4|||||2-Sided|95.0|-6.2|8.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621771|NCT02307682|2978252|Other||Difference in proportions|-3.1|||||2-Sided|95.0|-10.0|4.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621772|NCT02307682|2978252|Other||Difference in proportions|-2.1|||||2-Sided|95.0|-9.4|5.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621773|NCT02307682|2978252|Other||Difference in proportions|0.5|||||2-Sided|95.0|-6.6|7.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621774|NCT02307682|2978252|Other||Difference in proportions|-1.0|||||2-Sided|95.0|-7.9|5.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621775|NCT02307682|2978252|Other||Difference in proportions|-0.3|||||2-Sided|95.0|-7.2|6.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621776|NCT02307682|2978252|Other||Difference in proportions|1.0|||||2-Sided|95.0|-5.8|8.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621777|NCT02307682|2978252|Other||Difference in proportions|-0.6|||||2-Sided|95.0|-7.2|6.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621778|NCT02307682|2978252|Other||Difference in proportions|1.4|||||2-Sided|95.0|-5.5|7.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621779|NCT02307682|2978252|Other||Difference in proportions|-2.7|||||2-Sided|95.0|-9.7|4.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621780|NCT02307682|2978252|Other||Difference in proportions|-1.0|||||2-Sided|95.0|-8.0|5.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621781|NCT02307682|2978252|Other||Difference in proportions|-3.5|||||2-Sided|95.0|-10.4|3.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621782|NCT02307682|2978252|Other||Difference in proportions|-4.6|||||2-Sided|95.0|-11.1|2.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621783|NCT02307682|2978252|Other||Difference in proportions|-2.0|||||2-Sided|95.0|-9.1|5.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621784|NCT02307682|2978252|Other||Difference in proportions|-3.0|||||2-Sided|95.0|-9.6|3.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621785|NCT02307682|2978252|Other||Difference in proportions|0.9|||||2-Sided|95.0|-6.2|7.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621786|NCT02307682|2978252|Other||Difference in proportions|-1.6|||||2-Sided|95.0|-8.1|5.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621787|NCT02307682|2978252|Other||Difference in proportions|-5.4|||||2-Sided|95.0|-12.7|1.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621788|NCT02307682|2978252|Other||Difference in proportions|-6.0|||||2-Sided|95.0|-12.6|1.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621789|NCT02307682|2978252|Other||Difference in proportions|3.1|||||2-Sided|95.0|-3.9|10.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621790|NCT02307682|2978252|Other||Difference in proportions|2.0|||||2-Sided|95.0|-4.7|9.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621791|NCT02307682|2978252|Other||Difference in proportions|1.1|||||2-Sided|95.0|-6.3|7.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621792|NCT02307682|2978252|Other||Difference in proportions|-0.2|||||2-Sided|95.0|-7.2|6.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621793|NCT02307682|2978252|Other||Difference in proportions|2.5|||||2-Sided|95.0|-4.4|10.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621794|NCT02307682|2978252|Other||Difference in proportions|-0.9|||||2-Sided|95.0|-7.6|6.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621795|NCT02307682|2978252|Other||Difference in proportions|-4.1|||||2-Sided|95.0|-11.4|3.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621796|NCT02307682|2978252|Other||Difference in proportions|-3.1|||||2-Sided|95.0|-9.7|3.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621797|NCT02307682|2978252|Other||Difference in proportions|1.5|||||2-Sided|95.0|-5.3|8.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621798|NCT02307682|2978252|Other||Difference in proportions|-2.4|||||2-Sided|95.0|-9.8|4.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621799|NCT02307682|2978252|Other||Difference in proportions|2.1|||||2-Sided|95.0|-4.8|8.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621800|NCT02307682|2978252|Other||Difference in proportions|-1.4|||||2-Sided|95.0|-8.1|5.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621801|NCT02307682|2978252|Other||Difference in proportions|-1.8|||||2-Sided|95.0|-8.9|5.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621802|NCT02307682|2978252|Other||Difference in proportions|-0.3|||||2-Sided|95.0|-7.4|6.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621803|NCT02307682|2978252|Other||Difference in proportions|1.4|||||2-Sided|95.0|-5.3|8.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621804|NCT02307682|2978252|Other||Difference in proportions|-0.8|||||2-Sided|95.0|-7.7|6.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621805|NCT02307682|2978253|Other||Difference in proportions|5.7|||||2-Sided|95.0|-1.0|12.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621806|NCT02307682|2978253|Other||Difference in proportions|5.6|||||2-Sided|95.0|-1.9|12.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621807|NCT02307682|2978253|Other||Difference in proportions|3.9|||||2-Sided|95.0|-3.0|11.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621808|NCT02307682|2978253|Other||Difference in proportions|5.1|||||2-Sided|95.0|-1.6|12.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621809|NCT02307682|2978253|Other||Difference in proportions|3.3|||||2-Sided|95.0|-3.4|10.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621810|NCT02307682|2978253|Other||Difference in proportions|4.6|||||2-Sided|95.0|-2.5|11.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621811|NCT02307682|2978253|Other||Difference in proportions|2.1|||||2-Sided|95.0|-5.0|9.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621812|NCT02307682|2978253|Other||Difference in proportions|3.0|||||2-Sided|95.0|-3.9|10.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621813|NCT02307682|2978253|Other||Difference in proportions|1.7|||||2-Sided|95.0|-5.1|8.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621814|NCT02307682|2978253|Other||Difference in proportions|-0.1|||||2-Sided|95.0|-6.9|7.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621815|NCT02307682|2978253|Other||Difference in proportions|1.5|||||2-Sided|95.0|-5.0|8.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621816|NCT02307682|2978253|Other||Difference in proportions|2.5|||||2-Sided|95.0|-4.8|9.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621817|NCT02307682|2978253|Other||Difference in proportions|1.6|||||2-Sided|95.0|-5.4|8.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621818|NCT02307682|2978253|Other||Difference in proportions|5.2|||||2-Sided|95.0|-1.6|12.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621819|NCT02307682|2978253|Other||Difference in proportions|2.1|||||2-Sided|95.0|-4.8|9.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621820|NCT02307682|2978253|Other||Difference in proportions|2.7|||||2-Sided|95.0|-4.1|9.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621821|NCT02307682|2978253|Other||Difference in proportions|5.5|||||2-Sided|95.0|-1.4|13.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621822|NCT02307682|2978253|Other||Difference in proportions|4.0|||||2-Sided|95.0|-3.0|10.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621823|NCT02307682|2978253|Other||Difference in proportions|3.4|||||2-Sided|95.0|-3.5|11.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621824|NCT02307682|2978253|Other||Difference in proportions|-0.3|||||2-Sided|95.0|-7.0|7.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621825|NCT02307682|2978253|Other||Difference in proportions|-1.3|||||2-Sided|95.0|-8.6|5.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621826|NCT02307682|2978253|Other||Difference in proportions|1.0|||||2-Sided|95.0|-6.1|8.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621827|NCT02307682|2978253|Other||Difference in proportions|1.2|||||2-Sided|95.0|-5.8|8.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621828|NCT02307682|2978253|Other||Difference in proportions|0.5|||||2-Sided|95.0|-6.8|8.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621829|NCT02307682|2978253|Other||Difference in proportions|2.4|||||2-Sided|95.0|-4.5|9.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621830|NCT02307682|2978253|Other||Difference in proportions|-1.0|||||2-Sided|95.0|-7.9|6.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621831|NCT02307682|2978253|Other||Difference in proportions|0.2|||||2-Sided|95.0|-7.1|7.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621832|NCT02307682|2978253|Other||Difference in proportions|2.2|||||2-Sided|95.0|-4.4|9.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621833|NCT02307682|2978253|Other||Difference in proportions|2.3|||||2-Sided|95.0|-4.8|10.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621834|NCT02307682|2978253|Other||Difference in proportions|-0.9|||||2-Sided|95.0|-7.8|6.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621835|NCT02307682|2978253|Other||Difference in proportions|1.9|||||2-Sided|95.0|-5.2|8.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621836|NCT02307682|2978253|Other||Difference in proportions|-0.1|||||2-Sided|95.0|-7.3|6.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621837|NCT02307682|2978253|Other||Difference in proportions|3.6|||||2-Sided|95.0|-3.2|10.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621838|NCT02307682|2978253|Other||Difference in proportions|-1.6|||||2-Sided|95.0|-8.2|5.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621839|NCT02307682|2978253|Other||Difference in proportions|3.9|||||2-Sided|95.0|-3.4|11.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621840|NCT02307682|2978253|Other||Difference in proportions|1.2|||||2-Sided|95.0|-5.9|8.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621841|NCT02307682|2978253|Other||Difference in proportions|3.8|||||2-Sided|95.0|-3.5|11.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621842|NCT02307682|2978253|Other||Difference in proportions|2.5|||||2-Sided|95.0|-4.0|9.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621843|NCT02307682|2978253|Other||Difference in proportions|5.2|||||2-Sided|95.0|-1.8|12.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621844|NCT02307682|2978253|Other||Difference in proportions|0.3|||||2-Sided|95.0|-6.5|7.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621845|NCT02307682|2978253|Other||Difference in proportions|5.6|||||2-Sided|95.0|-1.5|12.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621846|NCT02307682|2978253|Other||Difference in proportions|1.0|||||2-Sided|95.0|-6.0|7.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621847|NCT02307682|2978253|Other||Difference in proportions|6.0|||||2-Sided|95.0|-0.8|12.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621848|NCT02307682|2978253|Other||Difference in proportions|0.5|||||2-Sided|95.0|-6.2|7.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621849|NCT02307682|2978253|Other||Difference in proportions|1.7|||||2-Sided|95.0|-4.7|8.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621850|NCT02307682|2978253|Other||Difference in proportions|0.3|||||2-Sided|95.0|-6.6|6.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621851|NCT02307682|2978253|Other||Difference in proportions|6.3|||||2-Sided|95.0|0.6|12.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621852|NCT02307682|2978253|Other||Difference in proportions|1.3|||||2-Sided|95.0|-4.3|6.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621853|NCT02307682|2978254|Other||Difference in proportions|7.2|||||2-Sided|95.0|1.4|13.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621854|NCT02307682|2978254|Other||Difference in proportions|5.5|||||2-Sided|95.0|-1.2|12.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 96|
1621855|NCT02307682|2978254|Other||Difference in proportions|5.9|||||2-Sided|95.0|0.0|12.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621856|NCT02307682|2978254|Other||Difference in proportions|1.6|||||2-Sided|95.0|-5.1|8.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 92|
1621857|NCT02307682|2978254|Other||Difference in proportions|8.0|||||2-Sided|95.0|1.9|14.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621858|NCT02307682|2978254|Other||Difference in proportions|4.1|||||2-Sided|95.0|-3.0|10.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 88|
1621859|NCT02307682|2978254|Other||Difference in proportions|4.2|||||2-Sided|95.0|-2.2|10.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621860|NCT02307682|2978254|Other||Difference in proportions|3.3|||||2-Sided|95.0|-3.7|9.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 84|
1621861|NCT02307682|2978254|Other||Difference in proportions|8.8|||||2-Sided|95.0|2.7|15.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621862|NCT02307682|2978254|Other||Difference in proportions|1.7|||||2-Sided|95.0|-5.1|8.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 80|
1621863|NCT02307682|2978254|Other||Difference in proportions|5.0|||||2-Sided|95.0|-1.0|11.6|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621864|NCT02307682|2978254|Other||Difference in proportions|6.0|||||2-Sided|95.0|-1.5|12.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 76|
1621865|NCT02307682|2978254|Other||Difference in proportions|5.1|||||2-Sided|95.0|-1.1|11.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621866|NCT02307682|2978254|Other||Difference in proportions|3.8|||||2-Sided|95.0|-3.0|9.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 72|
1621867|NCT02307682|2978254|Other||Difference in proportions|5.6|||||2-Sided|95.0|-0.2|11.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621868|NCT02307682|2978254|Other||Difference in proportions|2.4|||||2-Sided|95.0|-4.2|9.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 68|
1621869|NCT02307682|2978254|Other||Difference in proportions|5.8|||||2-Sided|95.0|-0.4|12.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621870|NCT02307682|2978254|Other||Difference in proportions|3.7|||||2-Sided|95.0|-2.9|10.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 64|
1621871|NCT02307682|2978254|Other||Difference in proportions|4.9|||||2-Sided|95.0|-1.3|11.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621872|NCT02307682|2978254|Other||Difference in proportions|-0.3|||||2-Sided|95.0|-6.5|6.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 60|
1621873|NCT02307682|2978254|Other||Difference in proportions|3.0|||||2-Sided|95.0|-3.1|9.7|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621874|NCT02307682|2978254|Other||Difference in proportions|0.8|||||2-Sided|95.0|-5.9|7.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 56|
1621875|NCT02307682|2978254|Other||Difference in proportions|4.8|||||2-Sided|95.0|-1.5|11.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621876|NCT02307682|2978254|Other||Difference in proportions|2.8|||||2-Sided|95.0|-3.9|9.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 52|
1621877|NCT02307682|2978254|Other||Difference in proportions|8.2|||||2-Sided|95.0|2.2|15.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621878|NCT02307682|2978254|Other||Difference in proportions|-0.2|||||2-Sided|95.0|-6.8|6.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 48|
1621879|NCT02307682|2978254|Other||Difference in proportions|7.6|||||2-Sided|95.0|0.7|13.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621880|NCT02307682|2978254|Other||Difference in proportions|1.0|||||2-Sided|95.0|-5.2|7.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 44|
1621881|NCT02307682|2978254|Other||Difference in proportions|8.3|||||2-Sided|95.0|2.0|15.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621882|NCT02307682|2978254|Other||Difference in proportions|1.5|||||2-Sided|95.0|-4.4|8.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 40|
1621883|NCT02307682|2978254|Other||Difference in proportions|8.1|||||2-Sided|95.0|2.1|14.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621884|NCT02307682|2978254|Other||Difference in proportions|1.0|||||2-Sided|95.0|-5.4|7.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 36|
1621885|NCT02307682|2978254|Other||Difference in proportions|7.9|||||2-Sided|95.0|1.5|14.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621886|NCT02307682|2978254|Other||Difference in proportions|1.2|||||2-Sided|95.0|-5.0|7.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 32|
1621887|NCT02307682|2978254|Other||Difference in proportions|3.2|||||2-Sided|95.0|-3.4|9.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621888|NCT02307682|2978254|Other||Difference in proportions|2.3|||||2-Sided|95.0|-4.3|8.5|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 28|
1621889|NCT02307682|2978254|Other||Difference in proportions|7.2|||||2-Sided|95.0|0.8|13.4|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621890|NCT02307682|2978254|Other||Difference in proportions|1.9|||||2-Sided|95.0|-4.2|7.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 24|
1621891|NCT02307682|2978254|Other||Difference in proportions|3.8|||||2-Sided|95.0|-2.4|9.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621892|NCT02307682|2978254|Other||Difference in proportions|0.3|||||2-Sided|95.0|-5.9|6.1|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 20|
1621893|NCT02307682|2978254|Other||Difference in proportions|2.3|||||2-Sided|95.0|-3.8|8.3|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621894|NCT02307682|2978254|Other||Difference in proportions|2.3|||||2-Sided|95.0|-3.7|8.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 16|
1621895|NCT02307682|2978254|Other||Difference in proportions|4.9|||||2-Sided|95.0|-0.5|11.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621896|NCT02307682|2978254|Other||Difference in proportions|0.2|||||2-Sided|95.0|-5.9|5.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 12|
1621897|NCT02307682|2978254|Other||Difference in proportions|4.2|||||2-Sided|95.0|-1.2|10.0|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621898|NCT02307682|2978254|Other||Difference in proportions|0.8|||||2-Sided|95.0|-4.4|5.9|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 8|
1621899|NCT02307682|2978254|Other||Difference in proportions|1.6|||||2-Sided|95.0|-2.8|5.8|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 6mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621900|NCT02307682|2978254|Other||Difference in proportions|-0.2|||||2-Sided|95.0|-4.2|4.2|||||Statistical model used logistic regression adjusting for BCVA categories, age categories, and treatment as fixed effect factors. 95% CI for difference in proportions (Brolucizumab 3mg - Aflibercept 2mg) was estimated using a bootstrap method.|Week 4|
1621901|NCT02307682|2978255|Other|Treatment difference|Least Squares Mean Difference|0.4|Standard Error of the Mean|1.06|||2-Sided|95.0|-1.7|2.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)||
1621902|NCT02307682|2978255|Other|Treatment difference|Least Squares Mean Difference|0.4|Standard Error of the Mean|1.08|||2-Sided|95.0|-1.7|2.5|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)||
1621903|NCT02307682|2978256|Other|Treatment difference|Least Squares Mean Difference|0.1|Standard Error of the Mean|0.92|||2-Sided|95.0|-1.7|1.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 96|
1621904|NCT02307682|2978256|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.91|||2-Sided|95.0|-1.9|1.7|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12 to Week 96|
1621905|NCT02307682|2978256|Other|Treatment difference|Least Squares Mean Difference|0.1|Standard Error of the Mean|0.85|||2-Sided|95.0|-1.6|1.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12 to Week 48|
1621906|NCT02307682|2978256|Other|Treatment difference|Least Squares Mean Difference|-0.4|Standard Error of the Mean|0.83|||2-Sided|95.0|-2.0|1.2|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12 to Week 48|
1621907|NCT02307682|2978257|Other|Treatment difference|Least Squares Mean Difference|0.0|Standard Error of the Mean|0.88|||2-Sided|95.0|-1.7|1.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 96|
1621908|NCT02307682|2978257|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.87|||2-Sided|95.0|-1.8|1.6|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 96|
1621909|NCT02307682|2978257|Other|Treatment difference|Least Squares Mean Difference|0.0|Standard Error of the Mean|0.8|||2-Sided|95.0|-1.5|1.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 4 to Week 48|
1621910|NCT02307682|2978257|Other|Treatment difference|Least Squares Mean Difference|-0.4|Standard Error of the Mean|0.76|||2-Sided|95.0|-1.9|1.1|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4 to Week 48|
1621911|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.5|Standard Error of the Mean|1.1|||2-Sided|95.0|-1.6|2.7|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 96|
1621912|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.3|Standard Error of the Mean|1.12|||2-Sided|95.0|-1.9|2.5|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 96|
1621913|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.4|Standard Error of the Mean|1.09|||2-Sided|95.0|-1.8|2.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 92|
1621914|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.3|Standard Error of the Mean|1.1|||2-Sided|95.0|-1.9|2.5|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 92|
1621915|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.3|Standard Error of the Mean|1.1|||2-Sided|95.0|-1.9|2.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 88|
1621916|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.4|Standard Error of the Mean|1.1|||2-Sided|95.0|-1.8|2.5|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 88|
1621917|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.3|Standard Error of the Mean|1.06|||2-Sided|95.0|-1.8|2.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 84|
1621918|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.6|Standard Error of the Mean|1.08|||2-Sided|95.0|-1.5|2.7|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 84|
1621919|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.7|Standard Error of the Mean|1.08|||2-Sided|95.0|-1.4|2.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 80|
1621920|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.6|Standard Error of the Mean|1.07|||2-Sided|95.0|-1.5|2.7|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 80|
1622106|NCT02301897|2978576|Superiority|||||||0.6541|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1621922|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.3|Standard Error of the Mean|1.07|||2-Sided|95.0|-1.8|2.4|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 76|
1621923|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.3|Standard Error of the Mean|1.07|||2-Sided|95.0|-2.4|1.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 72|
1621924|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.2|Standard Error of the Mean|1.08|||2-Sided|95.0|-2.0|2.3|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 72|
1621925|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|1.05|||2-Sided|95.0|-2.2|1.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 68|
1621926|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|1.04|||2-Sided|95.0|-2.1|2.0|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 68|
1621927|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.2|Standard Error of the Mean|1.05|||2-Sided|95.0|-2.2|1.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 64|
1621928|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.3|Standard Error of the Mean|1.04|||2-Sided|95.0|-2.3|1.7|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 64|
1621929|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|1.04|||2-Sided|95.0|-2.2|1.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 60|
1621930|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|1.03|||2-Sided|95.0|-2.1|1.9|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 60|
1621931|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.6|Standard Error of the Mean|1.03|||2-Sided|95.0|-2.7|1.4|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 56|
1621932|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.5|Standard Error of the Mean|1.0|||2-Sided|95.0|-2.5|1.5|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 56|
1621933|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.2|Standard Error of the Mean|1.04|||2-Sided|95.0|-2.2|1.9|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 52|
1621934|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.2|Standard Error of the Mean|1.03|||2-Sided|95.0|-2.2|1.8|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 52|
1621935|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.2|Standard Error of the Mean|1.0|||2-Sided|95.0|-2.1|1.8|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 48|
1621936|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.6|Standard Error of the Mean|0.98|||2-Sided|95.0|-2.5|1.3|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 48|
1621937|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.2|Standard Error of the Mean|1.0|||2-Sided|95.0|-1.8|2.2|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 44|
1621938|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|1.0|||2-Sided|95.0|-2.1|1.9|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 44|
1621939|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.1|Standard Error of the Mean|1.0|||2-Sided|95.0|-1.9|2.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 40|
1621940|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.3|Standard Error of the Mean|0.98|||2-Sided|95.0|-2.2|1.6|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 40|
1621941|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.2|Standard Error of the Mean|0.95|||2-Sided|95.0|-2.1|1.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 36|
1621942|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-1.0|Standard Error of the Mean|0.94|||2-Sided|95.0|-2.9|0.8|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 36|
1621943|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.6|Standard Error of the Mean|0.94|||2-Sided|95.0|-1.2|2.5|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 32|
1621944|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.5|Standard Error of the Mean|0.94|||2-Sided|95.0|-2.4|1.3|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 32|
1621945|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.4|Standard Error of the Mean|0.92|||2-Sided|95.0|-1.4|2.2|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 28|
1621946|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.92|||2-Sided|95.0|-1.9|1.7|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 28|
1621947|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.88|||2-Sided|95.0|-1.9|1.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 24|
1621948|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.4|Standard Error of the Mean|0.87|||2-Sided|95.0|-2.1|1.3|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 24|
1621949|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.5|Standard Error of the Mean|0.86|||2-Sided|95.0|-2.2|1.2|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 20|
1621950|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.6|Standard Error of the Mean|0.83|||2-Sided|95.0|-2.2|1.0|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 20|
1621951|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.5|Standard Error of the Mean|0.82|||2-Sided|95.0|-1.1|2.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 16|
1621952|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.82|||2-Sided|95.0|-1.8|1.5|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 16|
1621953|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|0.0|Standard Error of the Mean|0.8|||2-Sided|95.0|-1.5|1.6|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 12|
1621954|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.3|Standard Error of the Mean|0.76|||2-Sided|95.0|-1.8|1.2|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 12|
1621955|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.3|Standard Error of the Mean|0.73|||2-Sided|95.0|-1.7|1.2|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)|Week 8|
1621956|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.67|||2-Sided|95.0|-1.4|1.2|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 8|
1621957|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.64|||2-Sided|95.0|-1.4|1.1|||||Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)||
1621958|NCT02307682|2978258|Other|Treatment difference|Least Squares Mean Difference|-0.2|Standard Error of the Mean|0.59|||2-Sided|95.0|-1.4|0.9|||||Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)|Week 4|
1621959|NCT02307682|2978263|Non-Inferiority|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|0.0|Standard Error of the Mean|0.96|<|0.0001|2-Sided|95.0|-1.9|1.9||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)||
1621960|NCT02307682|2978263|Non-Inferiority|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.5|Standard Error of the Mean|0.95|<|0.0001|2-Sided|95.0|-2.4|1.3||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)||
1621961|NCT02307682|2978264|Non-Inferiority|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.2|Standard Error of the Mean|1.0|<|0.0001|2-Sided|95.0|-2.1|1.8||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 6mg - Aflibercept 2mg)||
1621962|NCT02307682|2978264|Non-Inferiority|The non-inferiority margin was 4 letters.|Least Squares Mean Difference|-0.6|Standard Error of the Mean|0.98|<|0.0003|2-Sided|95.0|-2.5|1.3||1-sided p-value reported. Hypothesis tested according to the pre-specified hierarchical testing that ensures the global type I error rate at 0.05.|ANOVA|Analyzed using ANOVA model with baseline BCVA categories, age categories, and treatment as fixed effect factors.|Least squares mean difference (Brolucizumab 3mg - Aflibercept 2mg)||
1621963|NCT02307513|2978271|Superiority||Difference in LS Mean|-5.5||||0.6182|2-Sided|95.0|-27.6|16.7|||ANCOVA|Based on an ANCOVA model for the change from baseline, with treatment arm, sex and region as factors and the baseline score as a covariate.|||
1621964|NCT02307513|2978272|Superiority||Difference in LS Mean|-0.1||||0.5944|2-Sided|95.0|-0.4|0.3|||ANCOVA|Based on an ANCOVA model for the change from baseline, with treatment arm, sex and region as factors and the baseline score as a covariate.|||
1621965|NCT02307513|2978273|Superiority||Difference in LS Means|-0.4||||0.0683|2-Sided|95.0|-0.9|0.0|||ANCOVA|ANCOVA model with treatment group, sex and region as factors and the baseline ulcers number as a covariate.|||
1621966|NCT02307513|2978274|Superiority||Hazard Ratio (HR)|0.611||||0.0112|2-Sided|95.0|0.408|0.915|||Stratified Log Rank Test|Treatment comparison is based on the stratified log-rank test, with sex and region as the stratification factors.|The HR is based on the stratified Cox model with baseline number of oral ulcers and sex and region as the stratification factors||
1621967|NCT02307513|2978275|Superiority||Adjusted difference in proportions|17.5||||0.0204|2-Sided|95.0|4.2|30.7|||Cochran-Mantel-Haenszel|Two-sided p-value was based on the CMH test, adjusting for sex and region.|Adjusted difference in proportions was the weighted average of the treatment differences across the 4 strata of combined sex and region factors with the CMH weights.||
1621968|NCT02307513|2978276|Superiority||Adjusted difference in proportions|28.4||||0.11|2-Sided|95.0|-3.6|60.4|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex.|||
1621969|NCT02307513|2978277|Superiority||Difference in LS Mean|-3.0||||0.0003||95.0|-4.5|-1.4|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.|||
1621970|NCT02307513|2978278|Superiority||Adjusted difference in proportions|30.6|||<|0.0001|2-Sided|95.0|18.1|43.1|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex and region.|||
1621971|NCT02307513|2978279|Superiority||Hazard Ratio (HR)|2.4|||<|0.0001|2-Sided|95.0|1.692|3.405|||Stratified Log-Rank Test|Treatment comparison is based on the stratified log-rank test, with sex and region as the stratification factors.|The HR is based on the stratified Cox model with baseline number of oral ulcers and sex and region as the stratification factors.||
1621972|NCT02307513|2978280|Superiority||Adjusted difference in percentages|25.1|||<|0.0001|2-Sided|95.0|15.5|34.6|||Cochran-Mantel-Haenszel|2 sided p-value based on the CMH test adjusting for sex and region.|||
1621973|NCT02307513|2978281|Superiority||Difference in LS Means|-0.9|||<|0.0001|2-Sided|95.0|-1.3|-0.5|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.|||
1621974|NCT02307513|2978282|Superiority||Difference in LS Means|-1.0|||<|0.0001|2-Sided|95.0|-1.4|-0.6|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.|||
1621975|NCT02307513|2978283|Superiority||Difference in LS Means|-0.5||||0.0335|2-Sided|95.0|-1.0|0.0|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.|||
1621976|NCT02307513|2978284|Superiority||Difference in LS Mean|-11.94|||<|0.0001||95.0|-16.2|-7.67|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.|||
1621977|NCT02307513|2978285|Superiority||Difference in LS Mean|-24.8|||<|0.0001|2-Sided|95.0|-32.8|-16.8|||ANCOVA|Based on an ANCOVA model for the change from baseline with the treatment arm, sex, region as factors and the baseline value as a covariate.|||
1621978|NCT02307513|2978286|Superiority||Difference in LS Mean|-92.6|||<|0.0001|2-Sided|95.0|-130.59|-54.6|||ANCOVA|ANCOVA model with AUCW0-12 as the response variables; treatment arm, sex, region as factors and the number of oral ulcers at baseline as a covariate.|||
1621979|NCT02307266|2978291|Superiority or Other|||||||0.0206|||||||Cochran-Mantel-Haenszel||||
1621980|NCT02307266|2978291|Superiority or Other|||||||0.3165|||||||Cochran-Mantel-Haenszel||||
1621981|NCT02305758|2978323|Superiority||Difference in proportions|-4.62|||||2-Sided|95.0|-21.4|12.1||||||Comparisons between treatment groups were performed using the Mantel-Haenszel method, stratified by planned bevacizumab use (planned use versus no planned use).|
1621982|NCT02305758|2978324|Superiority||Hazard Ratio (HR)|1.261|||||2-Sided|95.0|0.738|2.156||||||Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).|
1621983|NCT02305758|2978325|Superiority||Hazard Ratio (HR)|0.939|||||2-Sided|95.0|0.596|1.48||||||Comparisons between treatment groups were performed using the Cox Proportional Hazard Model, stratified by planned bevacizumab use (planned use versus no planned use).|
1621984|NCT02305381|2978340|Superiority or Other||Treatment difference|-1.35|||<|0.0001|2-Sided|95.0|-1.61|-1.1|||Mixed Models Analysis||Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening [≤8.0% or >8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate|
1621985|NCT02305381|2978340|Superiority or Other||Treatment difference|-1.75|||<|0.0001|2-Sided|95.0|-2.01|-1.5|||Mixed Models Analysis||Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Hierarchical testing was performed as per sequence listed below:Change in HbA1c: semaglutide 1.0 mg vs placebo. Change in HbA1c: semaglutide 0.5 mg vs placebo. Change in body weight: semaglutide 1.0 mg vs placebo. Change in body weight: semaglutide 0.5 mg vs placebo. Analysis was performed using MMRM with treatment, country and stratification variable (HbA1c at screening [≤8.0% or >8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate|
1621986|NCT02305238|2978352|Superiority or Other||MH adjusted difference|1.0|||||2-Sided|95.0|-10.6|12.7|||||||
1621987|NCT02305238|2978353|Superiority or Other||LS mean difference|-5.8|||||2-Sided|95.0|-24.3|12.7|||||||
1621988|NCT02305238|2978354|Superiority or Other||MH adjusted difference|-1.4|||||2-Sided|95.0|-12.7|9.8|||||||
1621989|NCT02305238|2978355|Superiority or Other||Mantel-Haenszel (MH) adjusted difference|-0.9|||||2-Sided|95.0|-5.7|4.0|||||||
1621990|NCT02305238|2978356|Superiority or Other||Least Square (LS) mean difference|-0.4|||||2-Sided|95.0|-3.8|3.0|||||||
1621991|NCT02304926|2978361|Superiority or Other||||||<|0.05|||||||ANOVA||||
1621992|NCT02304926|2978362|Superiority or Other||||||<|0.05|||||||ANOVA||||
1621993|NCT02304926|2978363|Superiority or Other||||||>|0.05|||||||ANOVA||||
1621994|NCT02304926|2978364|Superiority or Other||||||<|0.05|||||||ANOVA||||
1621995|NCT02304926|2978365|Superiority or Other||||||<|0.05|||||||ANOVA||||
1621996|NCT02304926|2978366|Superiority or Other||||||<|0.05|||||||ANOVA||||
1621997|NCT02304926|2978367|Superiority or Other||||||<|0.05|||||||ANOVA||||
1621998|NCT02304926|2978368|Superiority or Other||||||<|0.05|||||||ANOVA||||
1621999|NCT02304926|2978369|Superiority or Other||||||<|0.05|||||||ANOVA||||
1622000|NCT02304926|2978370|Superiority or Other||||||<|0.05|||||||ANOVA||||
1622001|NCT02304926|2978371|Superiority or Other||||||<|0.05|||||||ANOVA||||
1622002|NCT02304926|2978372|Superiority or Other||||||<|0.05|||||||ANOVA||||
1622003|NCT02304926|2978373|Superiority or Other||||||<|0.05|||||||ANOVA||||
1622004|NCT02304926|2978374|Superiority or Other||||||<|0.05|||||||ANOVA||||
1622005|NCT02304926|2978375|Superiority or Other||||||<|0.05|||||||ANOVA||||
1622006|NCT02304926|2978376|Superiority or Other||||||>|0.05|||||||ANOVA||||
1622007|NCT02304926|2978377|Superiority or Other||||||>|0.05|||||||ANOVA||||
1622008|NCT02304926|2978378|Superiority or Other||||||<|0.05|||||||ANOVA||||
1622009|NCT02304926|2978379|Superiority or Other||||||<|0.05|||||||ANOVA||||
1622010|NCT02304926|2978380|Superiority or Other||||||<|0.05|||||||ANOVA||||
1622011|NCT02304705|2978385|Superiority|||||||0.052|||||||t-test, 2 sided||||
1622012|NCT02304406|2978405|Other|||||||0.6877|||||||Cochran-Mantel-Haenszel||||
1622013|NCT02304406|2978406|Other|||||||0.0294|||||||Cochran-Mantel-Haenszel||||
1622014|NCT02304406|2978407|Other|||||||0.0862|||||||Cochran-Mantel-Haenszel||||
1622015|NCT02304406|2978408|Other|||||||0.1144|||||||Cochran-Mantel-Haenszel||||
1622016|NCT02304406|2978409|Other|||||||0.978|||||||Cochran-Mantel-Haenszel||||
1622017|NCT02304406|2978410|Other|||||||0.9231|||||||Cochran-Mantel-Haenszel||||
1622018|NCT02304406|2978411|Other|||||||0.8785|||||||Cochran-Mantel-Haenszel||||
1622019|NCT02304406|2978412|Other|||||||0.9067|||||||Cochran-Mantel-Haenszel||||
1622020|NCT02304406|2978413|Other|||||||0.901|||||||Cochran-Mantel-Haenszel||||
1622021|NCT02304406|2978414|Other|||||||0.4524|||||||Cochran-Mantel-Haenszel||||
1622022|NCT02304406|2978415|Other|||||||0.6422|||||||Cochran-Mantel-Haenszel||||
1622023|NCT02304406|2978416|Other||Odds Ratio (OR)|1.85||||0.1304|2-Sided|95.0|0.8|4.77|||Cochran-Mantel-Haenszel||||
1622024|NCT02303704|2978423|Superiority or Other||||||<|0.05||||||P-value <0.05 was considered to be significant i.e. operative mortality is not same between the two groups|Fisher Exact|Fisher exact test was used because 1 cell (25%) have expected count less than 5.||Null Hypothesis: Operative mortality ratio is same in both groups|
1622025|NCT02303704|2978424|Superiority or Other||||||<|0.05||||||p- value less than 0.05 was considered as significant difference in proportion between the two groups|Chi-squared|two compare the qualitative data between two groups||Null Hypothesis:The proportion of IABP use is same between the two groups|
1622026|NCT02303704|2978425|Non-Inferiority or Equivalence|to chek the equality of means between the two groups|||||<|0.05|||||||t-test, 2 sided||||
1622027|NCT02303704|2978426|Non-Inferiority or Equivalence|to check the equality of means|||||<|0.05||||||p-value <0.05 was considered significant.|t-test, 2 sided|To compare the means between the two groups, to find out the significant difference between Group I and II.||Null Hypothesis: The dose of nor-adrenaline on weaning from CPB is same for Group I and II.|
1622028|NCT02303704|2978427|Non-Inferiority or Equivalence|to check the equality of means between the two groups|||||<|0.05|||||||t-test, 2 sided||||
1622029|NCT02303704|2978428|Non-Inferiority or Equivalence|to check the equality of means|||||<|0.05||||||P-value less than 0.05 was considered significant|t-test, 2 sided|two compare two independent quantitative groups||Null hypothesis was there is no significant difference between the means of two groups|
1622030|NCT02303574|2978461|Other|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.157|Standard Error of the Mean|0.1098|||2-Sided|95.0|0.9285|1.385|||||||
1622031|NCT02303574|2978462|Other|Effect of food analysis by linear mixed effects ANOVA model with fixed effect of fasting status.|Ratio (%)|64.14|||||2-Sided|90.0|55.07|74.7|||||||
1622032|NCT02303574|2978462|Other||Slope|1.302|Standard Error of the Mean|0.05056|||2-Sided|95.0|1.198|1.406||||||Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|
1622033|NCT02303574|2978463|Other|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|158.68|||||2-Sided|90.0|146.67|171.67|||||||
1622034|NCT02303574|2978463|Other|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|151.82|||||2-Sided|90.0|138.23|166.74|||||||
1622035|NCT02303574|2978463|Other|ime dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|159.4|||||2-Sided|90.0|140.61|180.7|||||||
1622036|NCT02303574|2978463|Other|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.228|Standard Error of the Mean|0.1329|||2-Sided|95.0|0.9513|1.504|||||||
1622037|NCT02303574|2978464|Other|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|158.68|||||2-Sided|90.0|146.67|171.67|||||||
1622038|NCT02303574|2978464|Other|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|151.82|||||2-Sided|90.0|138.23|166.74|||||||
1622039|NCT02303574|2978464|Other|Time dependency was assessed via linear mixed effects ANOVA model with fixed effects of dose level, day and dose-level-by-day interaction.|Ratio (%)|159.4|||||2-Sided|90.0|140.61|180.7|||||||
1622040|NCT02303574|2978465|Other|Effect of food analysis by linear mixed effects ANOVA model with fixed effect of fasting status.|Ratio (%)|90.72|||||2-Sided|90.0|83.72|98.31|||||||
1622041|NCT02303574|2978465|Other|Dose proportionality was analyzed by power model. Slope parameter was obtained via linear least squares.|Slope|1.287|Standard Error of the Mean|0.05085|||2-Sided|95.0|1.183|1.391|||||||
1622042|NCT02302807|2978490|Superiority||Hazard Ratio (HR)|0.85|||||2-Sided|95.0|0.73|0.99|||||||
1622043|NCT02302807|2978490|Superiority||Hazard Ratio (HR)|0.87|||||2-Sided|95.0|0.71|1.05|||||||
1622044|NCT02302807|2978490|Superiority||Hazard Ratio (HR)|0.87||||0.4134|2-Sided|95.0|0.63|1.21|||Log Rank||||
1622045|NCT02302716|2978501|Non-Inferiority or Equivalence|The primary treatment comparison was to compare LY2963016 versus Lantus at the non-inferiority margin of +0.4%. If the upper limit of the 95% confidence interval on the change from baseline to 24-week HbA1c level for LY2963016 versus Lantus was below +0.4%, then LY2963016 would be declared non-inferior to Lantus.|Mean Difference (Final Values)|-0.04||||0.693|2-Sided|95.0|-0.22|0.15|||Mixed Models Analysis||||
1622046|NCT02302222|2978522|Superiority||Risk Difference (RD)|0.113||||0.1981|2-Sided|95.0|-0.016|0.243|||Fisher Exact||||
1622047|NCT02301988|2978546|Superiority||Difference in Response Rates|8.33||||0.6291|2-Sided|95.0|-33.04|49.71|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.||
1622048|NCT02301988|2978547|Superiority||Difference in Response Rates|4.2||||0.628|2-Sided|95.0|-14.37|22.76|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.||
1622049|NCT02301988|2978549|Superiority||Difference in Response Rates|9.66||||0.3032||95.0|-12.25|31.58|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.||
1622050|NCT02301988|2978550|Superiority||Difference in Response Rates|6.09||||0.498|2-Sided|95.0|-15.01|27.2|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction method.||
1622051|NCT02301988|2978551|Superiority||Difference in Response Rates|23.68||||0.1486|2-Sided|95.0|-13.57|60.94|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified Analysis|
1622052|NCT02301988|2978552|Superiority||Difference in response rate|11.11||||0.1607||95.0|-5.64|27.85|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis|
1622053|NCT02301988|2978553|Superiority||Difference in response rates|-2.96||||0.8169|2-Sided|95.0|-33.91|27.99|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis|
1622054|NCT02301988|2978554|Superiority||Difference in Response Rates|7.7||||0.2234|2-Sided|95.0|-5.95|21.35|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis|
1622055|NCT02301988|2978555|Superiority||Difference in response rates|3.29||||0.7817|2-Sided|95.0|-25.52|32.1|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified analysis|
1622056|NCT02301988|2978556|Superiority||Difference in Response Rates|3.77||||0.519||95.0|-8.99|16.54|||Chi-squared||95% CI for difference in rates were constructed using normal approximation (Wald) with continuity correction.|Unstratified Analysis|
1622057|NCT02301975|2978557|Other||Least square mean change difference|14.2|||<|0.001|2-Sided|95.0|9.9|18.5|||ANCOVA||||
1622058|NCT02301975|2978557|Other||Least square mean change difference|19.2|||<|0.001|2-Sided|95.0|14.9|23.5|||ANCOVA||||
1622059|NCT02301975|2978557|Other||Least square mean change difference|5.0|||<||2-Sided|95.0|0.7|9.3|||||||
1622060|NCT02301975|2978558|Other||Odds Ratio (OR)|1.27||||0.372|2-Sided|95.0|0.75|2.12|||Regression, Logistic||||
1622061|NCT02301975|2978558|Other||Odds Ratio (OR)|1.15||||0.595|2-Sided|95.0|0.69|1.9|||Regression, Logistic||||
1622062|NCT02301975|2978558|Other||Odds Ratio (OR)|0.91|||||2-Sided|95.0|0.53|1.54|||||||
1622063|NCT02301975|2978559|Other||Least square mean change difference|16.3|||<|0.001|2-Sided|95.0|12.2|20.4|||ANCOVA||||
1622064|NCT02301975|2978559|Other||Least square mean change difference|21.5|||<|0.001|2-Sided|95.0|17.4|25.6|||ANCOVA||||
1622065|NCT02301975|2978559|Other||Least square mean change difference|5.2|||<||2-Sided|95.0|1.1|9.4|||||||
1622066|NCT02301975|2978560|Other||Least square mean change difference|1.5||||0.115|2-Sided|95.0|-0.4|3.3|||ANCOVA||||
1622067|NCT02301975|2978560|Other||Least square mean change difference|2.7||||0.004|2-Sided|95.0|0.8|4.5|||ANCOVA||||
1622068|NCT02301975|2978560|Other||Least square mean change difference|1.2|||||2-Sided|95.0|-0.7|3.1|||||||
1622069|NCT02301975|2978561|Other||Least square mean change difference|1.4||||0.106|2-Sided|95.0|-0.3|3.2|||ANCOVA||||
1622070|NCT02301975|2978561|Other||Least square mean change difference|2.7||||0.002|2-Sided|95.0|0.9|4.4|||ANCOVA||||
1622071|NCT02301975|2978561|Other||Least square mean change difference|1.2|||||2-Sided|95.0|-0.5|3.0|||||||
1622072|NCT02301975|2978562|Other||Least square mean change difference|0.113|||<|0.001|2-Sided|95.0|0.08|0.147|||Mixed Models Analysis||||
1622073|NCT02301975|2978562|Other||Least square mean change difference|0.12|||<|0.001|2-Sided|95.0|0.086|0.153|||Mixed Models Analysis||||
1622074|NCT02301975|2978562|Non-Inferiority or Equivalence|Non-inferiority was defined if the lower bound of the 95% CI for the difference between mean change from Baseline in clinic visit for FF/VI and FP/S was more than -100 mL|Least square mean change difference|0.006|||<||2-Sided|95.0|-0.027|0.04|||||||
1622075|NCT02301975|2978563|Other||Least square mean change difference|0.104|||<|0.001|2-Sided|95.0|0.074|0.134|||Mixed Models Analysis||||
1622076|NCT02301975|2978563|Other||Least square mean change difference|0.123|||<|0.001|2-Sided|95.0|0.093|0.153|||Mixed Models Analysis||||
1622077|NCT02301975|2978563|Non-Inferiority or Equivalence|Non-inferiority was defined if the lower bound of the 95% CI for the difference between mean change from Baseline in clinic visit PM FEV1 for FF/VI and FP/S was more than -100 milliliter (mL)|Least square mean change difference|0.019|||<||2-Sided|95.0|-0.011|0.049|||||||
1622078|NCT02301897|2978573|Superiority|||||||0.0896|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Off-drug|
1622079|NCT02301897|2978573|Superiority|||||||0.1859|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Off-drug|
1622080|NCT02301897|2978573|Superiority|||||||0.0142|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622081|NCT02301897|2978573|Superiority|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622082|NCT02301897|2978573|Superiority|||||||0.0142|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622083|NCT02301897|2978573|Superiority|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622084|NCT02301897|2978573|Superiority|||||||0.0004|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622085|NCT02301897|2978573|Superiority|||||||0.0338|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622086|NCT02301897|2978574|Superiority|||||||0.8751|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622087|NCT02301897|2978574|Superiority|||||||0.7016|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622088|NCT02301897|2978574|Superiority|||||||0.2725|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622089|NCT02301897|2978574|Superiority|||||||0.7067|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622090|NCT02301897|2978574|Superiority|||||||0.243|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622091|NCT02301897|2978574|Superiority|||||||0.5904|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622092|NCT02301897|2978574|Superiority|||||||0.2075|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622093|NCT02301897|2978574|Superiority|||||||0.1262|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622094|NCT02301897|2978575|Superiority|||||||0.8922|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622095|NCT02301897|2978575|Superiority|||||||0.7678|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622096|NCT02301897|2978575|Superiority|||||||0.4468|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622097|NCT02301897|2978575|Superiority|||||||0.2218|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622098|NCT02301897|2978575|Superiority|||||||0.0639|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622099|NCT02301897|2978575|Superiority|||||||0.6761|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622100|NCT02301897|2978575|Superiority|||||||0.067|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622101|NCT02301897|2978575|Superiority|||||||0.1439|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622102|NCT02301897|2978576|Superiority|||||||0.9206|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622103|NCT02301897|2978576|Superiority|||||||0.1052|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622104|NCT02301897|2978576|Superiority|||||||0.4326|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622105|NCT02301897|2978576|Superiority|||||||0.8559|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622116|NCT02301897|2978577|Superiority|||||||0.048|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622117|NCT02301897|2978577|Superiority|||||||0.0653|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622118|NCT02301897|2978578|Superiority|||||||0.4614|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622119|NCT02301897|2978578|Superiority|||||||0.4506|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622120|NCT02301897|2978578|Superiority|||||||0.0807|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622121|NCT02301897|2978578|Superiority|||||||0.1318|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622122|NCT02301897|2978578|Superiority|||||||0.1114|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622123|NCT02301897|2978578|Superiority|||||||0.4005|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622124|NCT02301897|2978578|Superiority|||||||0.0298|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622125|NCT02301897|2978578|Superiority|||||||0.0651|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622126|NCT02301897|2978579|Superiority|||||||0.8733|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622127|NCT02301897|2978579|Superiority|||||||0.8275|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622128|NCT02301897|2978579|Superiority|||||||0.0392|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622129|NCT02301897|2978579|Superiority|||||||0.1416|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622130|NCT02301897|2978579|Superiority|||||||0.0831|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622131|NCT02301897|2978579|Superiority|||||||0.5932|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622132|NCT02301897|2978579|Superiority|||||||0.0151|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622133|NCT02301897|2978579|Superiority|||||||0.0504|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622134|NCT02301897|2978580|Superiority|||||||0.5302|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622135|NCT02301897|2978580|Superiority|||||||0.557|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622136|NCT02301897|2978580|Superiority|||||||0.0843|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622137|NCT02301897|2978580|Superiority|||||||0.243|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622138|NCT02301897|2978580|Superiority|||||||0.0101|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622139|NCT02301897|2978580|Superiority|||||||0.2168|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622140|NCT02301897|2978580|Superiority|||||||0.0601|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622141|NCT02301897|2978580|Superiority|||||||0.011|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622142|NCT02301897|2978581|Superiority|||||||0.0565|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622143|NCT02301897|2978581|Superiority|||||||0.1516|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622144|NCT02301897|2978581|Superiority|||||||0.008|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622145|NCT02301897|2978581|Superiority|||||||0.0788|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622146|NCT02301897|2978581|Superiority|||||||0.0006|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622147|NCT02301897|2978581|Superiority|||||||0.2117|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622148|NCT02301897|2978581|Superiority|||||||0.0059|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622149|NCT02301897|2978581|Superiority|||||||0.0069|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622150|NCT02301897|2978582|Superiority|||||||0.5371|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622151|NCT02301897|2978582|Superiority|||||||0.4497|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 24 FU|
1622152|NCT02301897|2978582|Superiority|||||||0.1419|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622153|NCT02301897|2978582|Superiority|||||||0.4262|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622154|NCT02301897|2978582|Superiority|||||||0.0505|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622155|NCT02301897|2978582|Superiority|||||||0.5637|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to On-Drug Course 2|
1622156|NCT02301897|2978582|Superiority|||||||0.0064|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622157|NCT02301897|2978582|Superiority|||||||0.0049|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622158|NCT02301897|2978583|Superiority|||||||0.3743|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 28 FU|
1622159|NCT02301897|2978583|Superiority|||||||0.0641|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Course 2 Week 28 FU|
1622160|NCT02301897|2978583|Superiority|||||||0.0007|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622161|NCT02301897|2978583|Superiority|||||||0.0309|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 2|
1622162|NCT02301897|2978583|Superiority|||||||0.3612|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to ODI Course 1|
1622163|NCT02301897|2978583|Superiority|||||||0.6666|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to ODI Course 1|
1622164|NCT02301897|2978583|Superiority|||||||0.0003|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622165|NCT02301897|2978583|Superiority|||||||0.0016|||||||Wilcoxon Rank-Sum Test|||Percentage CFB to Week 18 Course 1|
1622166|NCT02301897|2978584|Superiority|||||||0.2482|||||||Wilcoxon Rank-Sum Test|||CFB to Course 2 Week 28 FU|
1622167|NCT02301897|2978584|Superiority|||||||0.3545|||||||Wilcoxon Rank-Sum Test|||CFB to Course 2 Week 28 FU|
1622168|NCT02301897|2978584|Superiority|||||||0.4512|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 2|
1622169|NCT02301897|2978584|Superiority|||||||0.2232|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 2|
1622170|NCT02301897|2978584|Superiority|||||||0.7672|||||||Wilcoxon Rank-Sum Test|||CFB to ODI Course 1|
1622171|NCT02301897|2978584|Superiority|||||||0.9754|||||||Wilcoxon Rank-Sum Test|||CFB to ODI Course 1|
1622172|NCT02301897|2978584|Superiority|||||||0.1257|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 1|
1622173|NCT02301897|2978584|Superiority|||||||0.0167|||||||Wilcoxon Rank-Sum Test|||CFB to Week 18 Course 1|
1622174|NCT02301897|2978585|Superiority|||||||0.0004|||||||Chi-Square Test||||
1622175|NCT02301897|2978585|Superiority|||||||0.0719|||||||Chi-Square Test||||
1622176|NCT02301897|2978586|Superiority||||||<|0.001|||||||Chi-Square Test||||
1622177|NCT02301897|2978586|Superiority||||||<|0.0008|||||||Chi-Square Test||||
1622178|NCT02301793|2978587|Other||Odds Ratio (OR)|1.0||||0.05|2-Sided|95.0||||The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.|Regression, Logistic|||The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.|
1622179|NCT02301793|2978591|Other||Odds Ratio (OR)|1.0||||0.05|2-Sided|95.0||||The reported p-values were calculated by reiterating the multiple outputation procedure 1000 times, we estimated the odds ratios (ORs) and their 95% confidence intervals conditional on the floor and nurse.|Regression, Logistic|||The hypothesis comparing the different educational arms was evaluated using an intention-to-treat approach (i.e. all nurses were included regardless of training completion) accounting for clustering in the data and comparing rates of VTE prophylaxis dose non-administration at baseline and during the Post-Education period. Two per-protocol sensitivity analyses were performed. They compared the Baseline vs. Post-Education periods for nurses who received training and nurses who completed training.|
1622180|NCT02301403|2978612|Superiority||Odds Ratio (OR)|2.95|||<|0.001|2-Sided|95.0|1.69|5.14|||Regression, Logistic||||
1622181|NCT02301299|2978625|Other|For power calculation, we assumed that the intervention would be almost fully implemented in May 2016 and the EMS use would be observed until Dec 2017. Therefore, a post-intervention period would be 20 months. To have one-third of the study period as an intervention period, we planned to analyze five-year (60-month) data from January 2013 to December 2017.|||||<|0.0001|||||||Regression, Linear|||The effect size was defined as the sum of expected slope change in monthly EMS use rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05. The effect size is measured in slope of change over time (negative values indicate a decrease while positive values indicate an increase in % EMS use/month).|Using SAS PROC TIMESERIES, individual admission data were aggregated into monthly time series data to calculate a monthly EMS arrival rate. In this procedure, we also generated seasonally adjusted time series data to take into account a seasonal pattern. Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG. The statistical hypothesis of the regression model was that there are a level change and a slope change after the intervention. In the regression model, we included a time variable to account for a natural trend prior to the intervention introduction (or in absence of the intervention). We assumed that the patient population was stable during the five-year period and no other factors than the intervention affected the outcome; no other potential confounding factors were not considered. A backward elimination was used to correct for autocorrelation. Maximum likelihood method was used to estimate parameters.
1622182|NCT02301299|2978626|Other|For power calculation, we assumed that the intervention would be almost fully implemented in May 2016 and the early hospital arrival would be observed until Dec 2017. Therefore, a post-intervention period would be 20 months. To have one-third of the study period as an intervention period, we planned to analyze five-year (60-month) data from January 2013 to December 2017.|||||<|0.0001|||||||Regression, Linear|Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG.||The effect size was defined as the sum of expected slope change in monthly early hospital arrival rate over the standard deviation. Assuming an autocorrelation level of 0.3, both level and trend change effect size of 0.5 would be detectable at 90% power at a significance level of 0.05.|Using SAS PROC TIMESERIES, individual admission data were aggregated into monthly time series data to calculate a monthly early arrival rate. In this procedure, we also generated seasonally adjusted time series data to take into account a seasonal pattern. Using the seasonally adjusted time series data, we conducted linear regression analysis for time series data in PROC AUTOREG. The statistical hypothesis of the regression model was that there are a level change and a slope change after the intervention. In the regression model, we included a time variable to account for a natural trend prior to the intervention introduction (or in absence of the intervention). We assumed that the patient population was stable during the five-year period and no other factors than the intervention affected the outcome; no other potential confounding factors were not considered. A backward elimination was used to correct for autocorrelation. Maximum likelihood method was used to estimate parameters.
1622183|NCT02301169|2978627|Non-Inferiority or Equivalence|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by the Brief Pain Inventory (BPI), T4P1001 compared with placebo.|Mean Difference (Final Values)|1.683333||||0.3386|2-Sided|95.0|-1.83119|5.197857||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test|||
1622184|NCT02301169|2978628|Non-Inferiority or Equivalence|Null hypothesis: no difference in mean change from baseline to day 42 of pain intensity measured after heat pain stimuli, T4P1001 compared with placebo.|Mean Difference (Final Values)|0.7656429||||0.06204|2-Sided|95.0|-0.0406744|1.5719601||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test|||
1622216|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|-3.6||||0.421|2-Sided|95.0|-12.45|5.26||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 39||
1622185|NCT02301169|2978629|Non-Inferiority or Equivalence|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by Investigator Global Assessment of Change, T4P1001 compared with Placebo|Mean Difference (Final Values)|0.802381||||0.2353|2-Sided|95.0|-0.5457743|2.1505362||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test|||
1622186|NCT02301169|2978630|Non-Inferiority or Equivalence|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Worst Pain Score (WPS), T4P1001 compared with placebo.|Mean Difference (Final Values)|0.1255102||||0.7887|2-Sided|95.0|-0.8152493|1.0662697||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons.|t-test, 2 sided|Welch two sample t-test|||
1622187|NCT02301169|2978631|Non-Inferiority or Equivalence|Null hypothesis: no difference in mean change from baseline to day 42 of pain severity as measured by weekly means of the daily Average Pain Score (APS), T4P1001 compared with placebo|Mean Difference (Final Values)|0.3748299||||0.4162|2-Sided|95.0|-0.5479411|1.297601||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment group comparisons|t-test, 2 sided|Welch two sample t-test|||
1622188|NCT02300558|2978655|Other|||||||0.0087|||||||paired t- test|||Based on a 2-sided, paired t-test ( α = 0.05), and a standard deviation (SD) of 30 msec, a sample size of 40 participants provided greater than 95% power assuming a difference in mean daytime QTcF interval (AUC0-6/6) as measured by standard 12-lead ECG between baseline and Week 24 of 20 msec. The null hypothesis was that the mean difference between the baseline and Week 24 mean daytime QTcF interval was zero.|
1622189|NCT02300311|2978656|Superiority or Other||Odds Ratio (OR)|11.37|||<|0.0001|2-Sided|95.0|5.342|24.199|||Regression, Logistic|Ordinal logistic regression models adjusting for the continuous covariate ‘baseline PI’ and the categorical variable ‘country’ was performed.|Odds ratio of (Finalgon® cream / placebo)|"For the analysis of the repeated multinomial efficacy endpoint ‘patient assessment of efficacy’ on the last individual treatment day, ordinal logistic regression models is used.~Only non−missing data is analysed in the statistical model."|
1622190|NCT02300311|2978657|Superiority or Other||Mean Difference (Final Values)|-2.958|Standard Error of the Mean|0.381|<|0.0001|2-Sided|95.0|-3.712|-2.205|||ANCOVA|ANCOVA using the fixed, categorical effects of treatment and country as well as the continuous covariate of baseline PI.|Differences between the treatment group effects (Finalgon® cream – placebo)|The difference of average pain intensity from pre-dose baseline on the last individual treatment day was analysed using ANCOVA.|
1622191|NCT02300311|2978658|Superiority or Other||Mean Difference (Final Values)|-1.341|Standard Error of the Mean|0.248|<|0.0001|2-Sided|95.0|-1.832|-0.851||The statistical model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.|REML based repeated measures approach|restricted maximum likelihood (REML) based repeated measures approach|Differences between the treatment group effects (Finalgon® cream – placebo)|"PID4 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 4 hours.~The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, and 4 hours."|
1622192|NCT02300311|2978659|Superiority or Other||Mean Difference (Final Values)|-1.849|Standard Error of the Mean|0.306|<|0.0001|2-Sided|95.0|-2.454|-1.244||The model included the fixed, categorical effects of treatment, country, time and treatment-by-time interaction and the continuous covariate of baseline PI.|REML based repeated measures approach|restricted maximum likelihood (REML) based repeated measures approach|Differences between the treatment group effects (Finalgon® cream – placebo).|"PID8 utilised a restricted maximum likelihood (REML) based repeated measures approach, using all available longitudinal pain intensity observations at each post-baseline time up to 8 hours.~The statistical model was applied to the analysis of change from baseline in pain intensity at 0.5, 1, 2, 3, 4, 6 and 8 hours."|
1622193|NCT02300129|2978667|Superiority or Other|||||||0.742||||||P value associated to treatment effect in the model. Study design with a power of 80% and a type I error at 5% (two-sided).|ANOVA|Analysis of variance including sequence, subject (sequence), period and treatment as factors in the model|||
1622194|NCT02300077|2978674|Superiority|||||||0.02|||||||Kruskal-Wallis||||
1622195|NCT02300077|2978675|Superiority|||||||0.001|||||||Kruskal-Wallis||||
1622196|NCT02300077|2978676|Superiority|||||||0.01|||||||Kruskal-Wallis||||
1622197|NCT02300077|2978677|Superiority|||||||0.0001|||||||Chi-squared||||
1622198|NCT02300025|2978683|Superiority or Other||LS means ratio|68.5|||||2-Sided|90.0|40.4|116.2|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).|
1622199|NCT02300025|2978683|Superiority or Other||LS means ratio|103.0|||||2-Sided|90.0|62.6|169.6|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).|
1622200|NCT02300025|2978683|Superiority or Other||LS means ratio|97.6|||||2-Sided|90.0|59.3|160.6|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0 - ∞) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).|
1622379|NCT02295020|2979032|Superiority or Other|||||||0.232|||||||t-test, 2 sided||||
1622201|NCT02300025|2978684|Superiority or Other||LS means ratio|42.5|||||2-Sided|90.0|22.5|80.5|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).|
1622202|NCT02300025|2978684|Superiority or Other||LS means ratio|102.2|||||2-Sided|90.0|54.0|193.2|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).|
1622203|NCT02300025|2978684|Superiority or Other||LS means ratio|98.4|||||2-Sided|90.0|52.0|186.0|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|AUC (0-t) was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where, hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).|
1622204|NCT02300025|2978686|Superiority or Other||LS means ratio|39.0|||||2-Sided|90.0|25.1|60.7|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and severe hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).|
1622205|NCT02300025|2978686|Superiority or Other||LS means ratio|84.9|||||2-Sided|90.0|54.6|132.1|||||The 90% CI for differences in LS means between the test and reference treatments obtained from the mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model ANOVA to determine 90% CI of the ratio between normal hepatic function (reference) and moderate hepatic impairment (test) where hepatic impairment group was a fixed factor. The LS means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).|
1622206|NCT02300025|2978686|Superiority or Other||LS means ratio|92.2|||||2-Sided|90.0|59.2|143.4|||||The 90% CI for differences in LS means between test and reference treatments obtained from mixed model were also back-transformed to give 90% CIs for the ratio of the test treatment relative to the reference treatment.|Cmax was analyzed using a mixed model analysis of variance (ANOVA) to determine 90% confidence interval (CI) of the ratio between normal hepatic function (reference) and mild hepatic impairment (test) where hepatic impairment group was a fixed factor. The least squares (LS) means of the test and reference treatments obtained from the mixed model were back-transformed to give geometric LS means (a point estimate).|
1622207|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|-1.29||||0.809|2-Sided|95.0|-12.19|9.6||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 52||
1622208|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|-2.21||||0.559|2-Sided|95.0|-9.73|5.3||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 39||
1622209|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|-0.35||||0.896|2-Sided|95.0|-5.67|4.97||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 26||
1622210|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|-1.69||||0.411|2-Sided|95.0|-5.75|2.37||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Impact, Week 12||
1622211|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|4.39||||0.35|2-Sided|95.0|-5.06|13.84||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 52||
1622212|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|-2.41||||0.546|2-Sided|95.0|-10.32|5.5||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 39||
1622213|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|1.03||||0.704|2-Sided|95.0|-4.31|6.36||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 26||
1622214|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|1.23||||0.592|2-Sided|95.0|-3.31|5.78||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Activity, Week 12||
1622215|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|-7.98||||0.162|2-Sided|95.0|-19.35|3.4||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 52||
1622217|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|0.73||||0.793|2-Sided|95.0|-4.79|6.25||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 26||
1622218|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|-1.67||||0.481|2-Sided|95.0|-6.33|2.99||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Symptoms, Week 12||
1622219|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|-0.49||||0.903|2-Sided|95.0|-8.54|7.57||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 52||
1622220|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|-2.83||||0.382|2-Sided|95.0|-9.23|3.58||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 39||
1622221|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|0.89||||0.694|2-Sided|95.0|-3.58|5.36||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 26||
1622222|NCT02299375|2978743|Superiority or Other||Mean Difference (Net)|-0.67||||0.706|2-Sided|95.0|-4.2|2.85||Analysis was performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment by visit and Baseline by visit interactions.|Mixed Models Analysis||SGRQ Total, Week 12||
1622223|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|1.17||||0.517|2-Sided|95.0|-2.49|4.84||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 52||
1622224|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|1.45||||0.24|2-Sided|95.0|-0.99|3.89||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 39||
1622225|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|3.82||||0.231|2-Sided|95.0|-2.48|10.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 26||
1622226|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|0.41||||0.585|2-Sided|95.0|-1.08|1.91||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 18||
1622227|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|-0.46||||0.588|2-Sided|95.0|-2.13|1.21||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 12||
1622228|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|0.17||||0.826|2-Sided|95.0|-1.32|1.65||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 8||
1622229|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|0.67||||0.348|2-Sided|95.0|-0.74|2.08||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 4||
1622230|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|0.43||||0.607|2-Sided|95.0|-1.2|2.06||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Post-dose FEV1/FVC, Week 2||
1622231|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|1.44||||0.383|2-Sided|95.0|-1.85|4.73||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 52||
1622232|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|2.05||||0.102|2-Sided|95.0|-0.42|4.52||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 39||
1622233|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|1.32||||0.184|2-Sided|95.0|-0.63|3.27||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 26||
1622234|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|0.24||||0.803|2-Sided|95.0|-1.62|2.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 18||
1622235|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|-0.29||||0.715|2-Sided|95.0|-1.86|1.28||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 12||
1622380|NCT02295020|2979033|Superiority or Other|||||||0.181|||||||t-test, 2 sided||||
1622236|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|0.35||||0.644|2-Sided|95.0|-1.15|1.85||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 8||
1622237|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|0.13||||0.878|2-Sided|95.0|-1.53|1.79||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 4||
1622238|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|0.21||||0.746|2-Sided|95.0|-1.09|1.52||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||Pre-dose FEV1/FVC, Week 2||
1622239|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|2.67||||0.562|2-Sided|95.0|-6.58|11.92||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 52||
1622240|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|4.19||||0.043|2-Sided|95.0|0.13|8.25||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 39||
1622241|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|3.53||||0.041|2-Sided|95.0|0.14|6.92||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 26||
1622242|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|3.34||||0.052|2-Sided|95.0|-0.03|6.7||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 18||
1622243|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|0.4||||0.785|2-Sided|95.0|-2.5|3.29||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 12||
1622244|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|3.75||||0.025|2-Sided|95.0|0.49|7.01||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 8||
1622245|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|2.87||||0.032|2-Sided|95.0|0.25|5.49||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 4||
1622246|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|2.82||||0.044|2-Sided|95.0|0.08|5.55||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV6, Week 2||
1622247|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|2.34||||0.355|2-Sided|95.0|-2.7|7.38||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 52||
1622248|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|3.13||||0.077|2-Sided|95.0|-0.34|6.59||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 39||
1622249|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|3.33||||0.017|2-Sided|95.0|0.61|6.05||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 26||
1622250|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|1.37||||0.334|2-Sided|95.0|-1.43|4.17||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 18||
1622251|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|0.22||||0.853|2-Sided|95.0|-2.08|2.51||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 12||
1622252|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|2.19||||0.073|2-Sided|95.0|-0.2|4.58||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 8||
1622253|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|1.76||||0.095|2-Sided|95.0|-0.31|3.84||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 4||
1622254|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|1.75||||0.089|2-Sided|95.0|-0.27|3.77||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FEV1, Week 2||
1622381|NCT02294786|2979053|Superiority||Difference in Percentages|-4.8||||0.775|2-Sided|95.0|-29.2|20.0|||Chi-squared|||Cycle 1-3 (up to 9 weeks)|
1623072|NCT02289352|2979702|Superiority||||||<|0.0001|||||||t-test, 2 sided||||
1622255|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|2.16||||0.448|2-Sided|95.0|-3.5|7.82||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 52||
1622256|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|3.3||||0.103|2-Sided|95.0|-0.69|7.29||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 39||
1622257|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|4.69||||0.018|2-Sided|95.0|0.82|8.56||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 26||
1622258|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|2.7||||0.091|2-Sided|95.0|-0.43|5.82||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 18||
1622259|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|-0.14||||0.933|2-Sided|95.0|-3.4|3.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 12||
1622260|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|2.52||||0.21|2-Sided|95.0|-1.43|6.46||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 8||
1622261|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|2.44||||0.074|2-Sided|95.0|-0.24|5.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 6||
1622262|NCT02299375|2978750|Superiority or Other||Mean Difference (Net)|0.6||||0.661|2-Sided|95.0|-2.08|3.27||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||PP FVC, Week 2||
1622263|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.042||||0.64|2-Sided|95.0|-0.138|0.222||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 52||
1622264|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.048||||0.467|2-Sided|95.0|-0.083|0.18||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 39||
1622265|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.138||||0.038|2-Sided|95.0|0.008|0.267||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 26||
1622266|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.059||||0.283|2-Sided|95.0|-0.049|0.167||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 18||
1622267|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.012||||0.783|2-Sided|95.0|-0.075|0.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 12||
1622268|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.072||||0.111|2-Sided|95.0|-0.017|0.16||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 8||
1622269|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.054||||0.143|2-Sided|95.0|-0.018|0.126||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 4||
1622270|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.045||||0.315|2-Sided|95.0|-0.043|0.132||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Post-dose, Week 2||
1622271|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.083||||0.471|2-Sided|95.0|-0.143|0.309||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 52||
1622272|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.082||||0.267|2-Sided|95.0|-0.063|0.228||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 39||
1622273|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.067||||0.242|2-Sided|95.0|-0.045|0.18||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 26||
1622382|NCT02294734|2979061|Superiority or Other||Median Difference (Final Values)|1.114||||0.913|2-Sided|95.0|0.953|1.305|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|||
1622274|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.073||||0.172|2-Sided|95.0|-0.032|0.177||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 18||
1622275|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|-0.012||||0.813|2-Sided|95.0|-0.111|0.087||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 12||
1622276|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.073||||0.138|2-Sided|95.0|-0.024|0.169||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 8||
1622277|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.045||||0.348|2-Sided|95.0|-0.049|0.14|||MMRM||FVC Pre-dose, Week 4||
1622278|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.056||||0.241|2-Sided|95.0|-0.038|0.15||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FVC Pre-dose, Week 2||
1622279|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.102||||0.277|2-Sided|95.0|-0.086|0.291||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 52||
1622280|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.028||||0.622|2-Sided|95.0|-0.085|0.141||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 39||
1622281|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.084||||0.071|2-Sided|95.0|-0.007|0.175||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 26||
1622282|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.025||||0.608|2-Sided|95.0|-0.07|0.12||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 18||
1622283|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|-0.001||||0.97|2-Sided|95.0|-0.077|0.074||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 12||
1622284|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.052||||0.184|2-Sided|95.0|-0.025|0.128||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 8||
1622285|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.037||||0.256|2-Sided|95.0|-0.027|0.1||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 4||
1622286|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.025||||0.484|2-Sided|95.0|-0.046|0.097||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 post-dose, Week 2||
1622287|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.171||||0.107|2-Sided|95.0|-0.038|0.381||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 52||
1622288|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.114||||0.076|2-Sided|95.0|-0.012|0.241||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 39||
1622289|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.073||||0.152|2-Sided|95.0|-0.027|0.172||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 26||
1622290|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.059||||0.259|2-Sided|95.0|-0.044|0.163||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 18||
1622291|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.003||||0.949|2-Sided|95.0|-0.084|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 12||
1622292|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.075||||0.131|2-Sided|95.0|-0.023|0.173||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 8||
1622293|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.046||||0.276|2-Sided|95.0|-0.037|0.129||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 4||
1623171|NCT02285010|2980159|Non-Inferiority|Alpha 0.05, beta 80%||||||0.05||||||P-Value 0.05 was calculated.|Chi-squared||||
1622294|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.051||||0.223|2-Sided|95.0|-0.032|0.134||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV6 pre-dose, Week 2||
1622295|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.043||||0.506|2-Sided|95.0|-0.087|0.172||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 52||
1622296|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.055||||0.248|2-Sided|95.0|-0.039|0.148||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 39||
1622297|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.099||||0.007|2-Sided|95.0|0.028|0.17||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 26||
1622298|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.023||||0.489|2-Sided|95.0|-0.043|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 18||
1622299|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|-0.012||||0.665|2-Sided|95.0|-0.066|0.042||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 12||
1622300|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.033||||0.266|2-Sided|95.0|-0.025|0.09||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 8||
1622301|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.04||||0.084|2-Sided|95.0|-0.005|0.086||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 4||
1622302|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.014||||0.521|2-Sided|95.0|-0.03|0.059||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 post-dose, Week 2||
1622303|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.05||||0.481|2-Sided|95.0|-0.09|0.191||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 52||
1622304|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.086||||0.057|2-Sided|95.0|-0.003|0.174||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 39||
1622305|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.079||||0.024|2-Sided|95.0|0.011|0.148||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 26||
1622306|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.05||||0.127|2-Sided|95.0|-0.014|0.114||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 18||
1622307|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|-0.002||||0.942|2-Sided|95.0|-0.063|0.058||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 12||
1622308|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.059||||0.05|2-Sided|95.0|0.0|0.119||Analysis performed using a mixed-effects repeated measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 8||
1622309|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.035||||0.244|2-Sided|95.0|-0.024|0.093||Analysis performed using a Mixed-effect Repeated Measures model with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 4||
1622310|NCT02299375|2978751|Superiority or Other||Mean Difference (Net)|0.026||||0.371|2-Sided|95.0|-0.031|0.084||Analysis performed using a Mixed-effect Model Repeated Measures (MMRM) with covariates of treatment, smoking status at Screening, ICS use, region, Baseline, visit, treatment and Baseline by visit interactions. Toeplitz structure was used.|MMRM||FEV1 pre-dose, Week 2||
1622311|NCT02299375|2978754|Superiority or Other||Adjusted median|1.04|Standard Deviation|0.28|||2-Sided|95.0|0.63|1.73|||||Data presented above are for 95% equal-tailed credible intervals. The estimated posterior probability that the true ratio losmapimod/placebo is <1 assuming noninformative priors is 0.44.The estimated posterior probability that the true ratio losmapi||
1622312|NCT02299076|2978793|Superiority|Welch Two Sample t-test|||||<|0.0001|||||||t-test, 2 sided||||
1622327|NCT02298192|2978844|Non-Inferiority or Equivalence|The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D <0.30%.|Treatment Contrast|0.12||||0.012|2-Sided|95.0|-0.04|0.28|||Mixed Models Analysis|||The null hypothesis was tested against the alternative hypothesis of non-inferiority as given by H0: D ≥0.30% against HA: D <0.30%.|
1623172|NCT02285010|2980160|Non-Inferiority|Alpha 0.05, beta 80%||||||0.05|||||||Chi-squared|||For visual disturbance|
1622313|NCT02298842|2978823|Non-Inferiority|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|43.8|Standard Deviation|26.05|||1-Sided|97.5|36.821||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that Morphology's mean difference, Test - 0.8 * Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|
1622314|NCT02298842|2978824|Non-Inferiority|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-2.389|Standard Deviation|9.0544|||1-Sided|97.5|-4.915||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that HSR's mean difference, Test - 0.8 * Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|
1622315|NCT02298842|2978825|Non-Inferiority|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-3.042|Standard Deviation|5.422|||1-Sided|97.5|-4.407||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that ESC's mean difference, Test - 0.8 * Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|
1622316|NCT02298842|2978826|Non-Inferiority|Lower value is considered to indicate better platelet quality. If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|12.314|Standard Deviation|6.0422|||1-Sided|97.5||13.981|||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that P-selection's mean difference, Test - 1.25 * Control, is greater or equal to 0, and the alternative is that the mean difference is less than 0.|
1622317|NCT02298842|2978827|Non-Inferiority|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|46.1|Standard Deviation|23.056|||1-Sided|97.5|40.02||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that Morphology's mean difference, Test - 0.8 * Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|
1622318|NCT02298842|2978828|Non-Inferiority|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|-0.667|Standard Deviation|6.7882|||1-Sided|97.5|-2.499||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that HSR's mean difference, Test - 0.8 * Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|
1622319|NCT02298842|2978829|Non-Inferiority|Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Median Difference (Final Values)|-0.418|Standard Deviation|4.5531|||1-Sided|97.5|-1.544||||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that ESC's mean difference, Test - 0.8 * Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.|
1622320|NCT02298842|2978830|Non-Inferiority|If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.|Mean Difference (Final Values)|15.099|Standard Deviation|5.6367|||1-Sided|97.5||16.738|||||Estimated from an ANCOVA with effects of treatment and subject nested within sequence.|The null hypothesis is that P-selectin's mean difference, Test - 1.25 * Control, is greater than or equal to 0, and the alternative is that the mean difference is less than 0.|
1622321|NCT02298842|2978831|Non-Inferiority|The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH> 6.2 will be at least 95%. This will be achieved if zero failures (pH<=6.2) is seen.|Simple sample proportion|100.0|Standard Deviation|0.0|||1-Sided|95.0|95.1||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|A “success” is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria.|
1622322|NCT02298842|2978832|Non-Inferiority|The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH> 6.2 will be at least 95%. This will be achieved if zero failures (pH<=6.2) is seen.|Simple sample proportion|100.0|Standard Deviation|0.0|||1-Sided|95.0|95.1||||||Estimated proportion is 100%. Hence standard deviation is estimated as 0.|A “success” is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria.|
1622323|NCT02298361|2978838|Superiority or Other||Odds Ratio (OR)|0.55|||||2-Sided|95.0|0.45|0.67|||||Adjusted odds of losing Medicaid: intervention patients (numerator) relative to control clinic comparison patients (denominator)||
1622324|NCT02298361|2978838|Superiority or Other||Odds Ratio (OR)|0.71|||||2-Sided|95.0|0.53|0.94|||||Adjusted odds of losing Medicaid: intervention patients (numerator) relative to within-clinic comparison patients (denominator)||
1622325|NCT02298361|2978839|Superiority or Other||Odds Ratio (OR)|2.28|||||2-Sided|95.0|1.91|2.72|||||Adjusted odds of gaining Medicaid: intervention patients (numerator) relative to control clinic comparison patients (denominator)||
1622326|NCT02298361|2978839|Superiority or Other||Odds Ratio (OR)|1.76|||||2-Sided|95.0|1.6|1.93|||||Adjusted odds of gaining Medicaid: intervention patients (numerator) relative to within-clinic comparison patients (denominator)||
1622328|NCT02297815|2978865|Superiority||Risk Difference (RD)|4.6||||0.07|2-Sided|95.0|-0.3|9.6|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.|
1622329|NCT02297815|2978866|Superiority or Other||Risk Difference (RD)|4.9||||0.09|2-Sided|95.0|-0.8|10.6|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.|
1622330|NCT02297815|2978867|Superiority or Other||Risk Difference (RD)|12.2|||<|0.001|2-Sided|95.0|7.3|17.2|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.|
1622331|NCT02297815|2978868|Superiority or Other||Risk Difference (RD)|1.5||||0.59|2-Sided|95.0|-3.9|6.8|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.|
1622332|NCT02297815|2978869|Superiority or Other||Risk Difference (RD)|2.4||||0.39|2-Sided|95.0|-3.1|7.9|||Weighted logistic regression|Propensity-score based full matching. Average treatment effect weights calculated and applied to a weighted logistic regression.|Broad spectrum antibiotics are the reference. A risk difference more than 0 indicates that the broad spectrum antibiotics had a higher risk of adverse outcome|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted logistic regression. Risk difference obtained by marginal standardization.|
1622333|NCT02297815|2978870|Superiority or Other||Score difference|-1.4||||0.008|2-Sided|95.0|-2.44|-0.36|||Weighted linear regression|Propensity-score based full matching performed. Average treatment effect weights calculated and applied to a weighted linear regression.|Narrow antibiotics is the reference group. A score difference less than zero indicates that broad spectrum antibiotics are associated with a lower (poorer) health related quality of life score.|Propensity-score based full matching performed using patient and physician-level characteristics. Average treatment effect weights calculated and applied to a weighted linear regression.|
1622334|NCT02297412|2978887|Superiority or Other|||||||0.0243|||||||Wilcoxon (Mann-Whitney)||||
1622335|NCT02297412|2978888|Superiority or Other|||||||0.1146|||||||Wilcoxon (Mann-Whitney)||||
1622336|NCT02297412|2978889|Superiority or Other|||||||0.0186|||||||Wilcoxon (Mann-Whitney)||||
1622337|NCT02296892|2978904|Superiority||Difference in Rates|0.7588|||<|0.0001|2-Sided|95.0|0.6903|0.8274|||Cochran-Mantel-Haenszel||||
1622338|NCT02296424|2978949|Equivalence|nominal 2.5% two-sided significance level was expected to have 90% powe to detect a difference between the Null Hypothesis proportion of patients who remain at their dose level.||||||0.0001|||||||exact binomial test||||
1622339|NCT02296320|2978962|Superiority||Relative risk reduction|31.9||||0.166|2-Sided|90.0|-7.5|56.8|||Poisson regression with robust variance|||The key efficacy analyses were based on 5000 mg MEDI4893 and placebo. Participants who received 2000 mg MEDI4893 were summarized descriptively.|
1622340|NCT02296242|2978967|Other||Highest dose (mg) with no DLTs.|600.0|||||2-Sided|||||||||In Part 1, 2 patients experienced DLTs in the 750 mg b.i.d. treatment group (2/7; 29%). There were no dose-limiting toxicities in the 600 mg b.i.d. group or 300 mg b.i.d. group. Therefore, based on these results, 600 mg b.i.d. was selected as the MTD dose (and RP2D dose) which was used as the treatment dose in Part 2 of the study.|
1622341|NCT02296138|2978969|Superiority||Hazard Ratio (HR)|1.09||||0.7357|2-Sided|95.0|0.67|1.75|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox’s proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value|
1622342|NCT02296138|2978970|Superiority||Hazard Ratio (HR)|0.93||||0.2773|2-Sided|95.0|0.82|1.06|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox’s proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value|
1622343|NCT02296138|2978971|Superiority||Ratio of events vs. Tiotropium 5 μg|0.89||||0.1265|2-Sided|95.0|0.76|1.03|||Negative binomial model||Ratio of events Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg) is provided.|Annualised rate of exacerbations leading to hospitalization was analysed using a negative binomial model including the fixed, categorical effect of treatment as well as the logarithm of the treatment exposure as an offset.|
1622344|NCT02296138|2978972|Superiority|This hypothesis testing strategy ensures that the overall type I error is protected at 2-sided 0.01 level.|Hazard Ratio (HR)|0.95||||0.1188|2-Sided|99.0|0.87|1.03|||Log Rank||Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg)|A Cox’s proportional hazard model was used to estimate the hazard ratio and the corresponding Confidence Interval. A log-rank test was used to obtain the p-value|
1622345|NCT02296138|2978973|Superiority||Ratio of rates|0.89||||0.0011|2-Sided|95.0|0.84|0.96|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on TRINITY/TRILOGY- Covariates: Treatment, region, severity of airflow limitation, and smoking status as effects, and exacerbations treated with antibiotics/steroids in previous year.|
1622346|NCT02296138|2978973|Superiority||Ratio of rates|0.91||||0.008|2-Sided|95.0|0.85|0.98|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on HERMES- Covariates: age, sex, smoking status, baseline Long-acting Beta-agonist/inhaled corticosteroid, region and percent predicted post-bronchodilator Forced Expiratory Volume in One Second|
1622347|NCT02296138|2978973|Superiority||Ratio of rates|0.89||||0.001|2-Sided|95.0|0.84|0.96|||Negative binomial model||Ratio of rates Tiotropium (5 μg) versus Tiotropium (5 μg) + Olodaterol (5 μg) is provided.|Model was based on SPARK/FLAME- Covariates: Smoking status, baseline inhaled corticosteroid, Global Initiative on Chronic Obstructive Lung Disease stage, region, COPD Assessment Test score (replacing baseline symptom score), exacerbations treated with antibiotics/steroids history in previous year (replacing 1-year history of exacerbations)|
1622348|NCT02296138|2978973|Superiority|This hypothesis testing strategy ensures that the overall type I error is protected at 2-sided 0.01 level.|Ratio of rates vs. Tiotropium 5 μg|0.93||||0.0498|2-Sided|99.0|0.85|1.02|||Negative binomial model||Ratio of events Tiotropium (5 μg) + Olodaterol (5 μg) versus Tiotropium (5 μg) is provided.|Annualised rate of moderate to severe COPD exacerbation was analysed using a negative binomial model including the fixed, categorical effect of treatment as well as the logarithm of the treatment exposure as an offset.|
1622349|NCT02296125|2978980|Superiority||Hazard Ratio (HR)|0.68||||0.1965||95.0|0.38|1.22|||Log Rank||||
1622350|NCT02296125|2978980|Superiority||Hazard Ratio (HR)|0.63||||0.0068|2-Sided|95.0|0.45|0.88|||Log Rank||||
1622351|NCT02296125|2978982|Superiority||Odds Ratio (OR)|1.67||||0.5772|2-Sided|95.0|0.27|12.98|||Regression, Logistic||An odds ratio >1 favours osimertinib||
1622352|NCT02296125|2978982|Superiority||Odds Ratio (OR)|2.78||||0.011|2-Sided|95.0|1.25|6.78|||Regression, Logistic||An odds ratio > 1 favours osimertinib||
1622353|NCT02296125|2978984|Superiority||Odds Ratio (OR)|1.31||||0.485||95.0|0.61|2.84|||Regression, Logistic||||
1622354|NCT02296125|2978984|Superiority||Odds Ratio (OR)|1.51||||0.036|2-Sided|95.0|1.03|2.22|||Regression, Logistic||||
1622355|NCT02296125|2978986|Superiority||Hazard Ratio (HR)|0.56||||0.0065||95.0|0.37|0.85|||Log Rank||||
1622356|NCT02296125|2978986|Superiority||Hazard Ratio (HR)|0.46|||<|0.0001|2-Sided|95.0|0.37|0.57|||Log Rank||||
1622357|NCT02296099|2979006|Equivalence|The Mann-Whitney U test was utilized.||||||0.014||||||The p-value was not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|There were no adjustments.||The null hypothesis is that there is no difference in the pain scores between the two groups.|
1622358|NCT02295995|2979007|Other|||||||||||||||||The between-group difference at 12 weeks [mean difference (MD) and 95% Confidence Interval] was calculated for all outcome measures. Cohen’s d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for 6-minute walk in this sample was 0.50|Cohen's d calculated as the change from baseline to 12 weeks in both groups.
1622359|NCT02295995|2979008|Other|||||||||||||||||The between-group difference at 12 weeks [mean difference (MD) and 95% Confidence Interval] was calculated for all outcome measures. Cohen’s d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for PCL-5 in this sample was 0.38|Cohen's d calculated as the change from baseline to 12 weeks in both groups.
1622360|NCT02295995|2979009|Other|||||||||||||||||The between-group difference at 12 weeks [mean difference (MD) and 95% Confidence Interval] was calculated for all outcome measures. Cohen’s d effect sizes were calculated as the difference in mean-level change (from baseline to 12 weeks) between the two groups divided by the standard deviation (SD) and is interpreted as d=0.20 (small), d=0.50 (medium), and d=0.80 (large). Cohen's d for physical activity in this sample was 1.37|Cohen's d calculated as the change from baseline to 12 weeks in both groups.
1622361|NCT02295774|2979012|Superiority or Other||Mc Nemar’s χ2 test|0.0|||||2-Sided||||||||Mc Nemar’s χ2 test was not applicable because there is no change between visits.|"The results of the γH2AX analysis were listed and summarised by frequency tables by visit and colonic region.~The results were compared between Visit 2 and Visit 1 for each colonic region and overall using the Mc Nemar’s χ2 test.~In case of the presence of at least one positive colonic region, that visit was to be considered as ‘Positive’ for the overall γH2AX analysis."|
1622362|NCT02295644|2979013|Superiority or Other|||||||0.178|||||||ANOVA|||Interaction of intensity and duty cycle.|
1622363|NCT02295644|2979013|Superiority or Other|||||||0.475|||||||ANOVA|||Main effect for intensity.|
1622364|NCT02295644|2979013|Superiority or Other|||||||0.034||||||Main effect for duty cycle.|ANOVA||||
1622365|NCT02295644|2979014|Superiority or Other|||||||0.17|||||||ANOVA|||Interaction of intensity and duty cycle.|
1622366|NCT02295644|2979014|Superiority or Other|||||||0.019||||||Main effect for intensity.|ANOVA||||
1622367|NCT02295644|2979014|Superiority or Other|||||||0.24||||||Main effect for duty cycle.|ANOVA||||
1622368|NCT02295644|2979015|Superiority or Other|||||||1||||||Main effect of intensity on self reported pain score.|ANOVA||||
1622369|NCT02295644|2979015|Superiority or Other|||||||0.14||||||Main effect of duty cycle on self reported pain score.|ANOVA||||
1622370|NCT02295644|2979015|Superiority or Other|||||||0.17||||||Interaction test of duty cycle and intensity for self reported pain score|ANOVA||||
1622371|NCT02295280|2979020|Superiority|||||||0.14||||||Reduction in pain scores by at least 2 units six hours post administration|Mann Whitney U test|Mann Whitney U test used for analysis of this continuous variable as data were not normally distributed. Outcome was comparable at the 6-hour mark.||A sample size calculation of 35 patients in each group was based on an estimated reduction in headache pain score by at least two points, with an a of 0.05 and power of 90%, which is similar to estimates reported in prior studies in non-pregnant patients and felt to be a clinically significant decrease. Statistical analyses were performed using chi-square, Fisher's exact test for categorical variables, the independent Student's t-test and Kolmogorov-Smirnov for continuous variables.|
1622372|NCT02295020|2979024|Superiority or Other|||||||0.878|||||||Wilcoxon (Mann-Whitney)||||
1622373|NCT02295020|2979025|Superiority or Other|||||||0.323|||||||Wilcoxon (Mann-Whitney)||||
1622374|NCT02295020|2979026|Superiority or Other|||||||0.479|||||||Wilcoxon (Mann-Whitney)||||
1622383|NCT02294734|2979061|Superiority or Other||Median Difference (Final Values)|1.171||||0.965|2-Sided|95.0|0.988|1.388|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|||
1622384|NCT02294734|2979064|Superiority or Other||Median Difference (Final Values)|0.114||||0.697|2-Sided|95.0|-0.324|0.549|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84||
1622385|NCT02294734|2979064|Superiority or Other||Median Difference (Final Values)|0.18||||0.817|2-Sided|95.0|-0.216|0.57|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28||
1622386|NCT02294734|2979065|Superiority or Other||Median Difference (Final Values)|0.121||||0.712|2-Sided|95.0|-0.305|0.551|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84||
1622387|NCT02294734|2979065|Superiority or Other||Median Difference (Final Values)|-0.144||||0.151|2-Sided|95.0|-0.42|0.133|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28||
1622388|NCT02294734|2979068|Superiority or Other||Median Difference (Final Values)|60.6||||0.816|2-Sided|95.0|-73.3|194.3|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 84||
1622389|NCT02294734|2979068|Superiority or Other||Median Difference (Final Values)|-2.0||||0.487|2-Sided|95.0|-118.5|115.3|||Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|Day 28||
1622390|NCT02294734|2979076|Superiority or Other||Posterior Median Ratio|1.0||||45.28|2-Sided|95.0|0.98|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length/Diameter Day 28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622391|NCT02294734|2979076|Superiority or Other||Posterior Median Ratio|0.99||||66.51|2-Sided|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622392|NCT02294734|2979076|Superiority or Other||Posterior Median Ratio|1.01||||32.15|2-Sided|95.0|0.97|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length/Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622393|NCT02294734|2979076|Superiority or Other||Posterior Median Ratio|1.01||||28.51|2-Sided|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length/Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622394|NCT02294734|2979077|Superiority or Other||Posterior Median Ratio|0.99||||25.05|2-Sided|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622395|NCT02294734|2979077|Superiority or Other||Posterior Median Ratio|1.0||||34.93|2-Sided|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622396|NCT02294734|2979077|Superiority or Other||Posterior Median Ratio|1.0||||71.08|2-Sided|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622397|NCT02294734|2979077|Superiority or Other||Posterior Median Ratio|0.99||||84.29|2-Sided|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622398|NCT02294734|2979077|Superiority or Other||Posterior Median Ratio|1.01||||75.2|2-Sided|95.0|0.98|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Diameter Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1623950|NCT02263326|2981799|Other|||||||0.074|||||||Wilcoxon (Mann-Whitney)||||
1622399|NCT02294734|2979077|Superiority or Other||Posterior Median Ratio|1.02||||86.21|2-Sided|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Diameter Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622400|NCT02294734|2979077|Superiority or Other||Posterior Median Ratio|1.02||||8.49|2-Sided|95.0|0.99|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622401|NCT02294734|2979077|Superiority or Other||Posterior Median Ratio|1.04||||2.89|2-Sided|95.0|1.0|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Length Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622402|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.0||||48.97|2-Sided|95.0|0.97|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622403|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|0.99||||73.01|2-Sided|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622404|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.0||||39.81|2-Sided|95.0|0.97|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622405|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|0.99||||69.67|2-Sided|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622406|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.0||||63.04|2-Sided|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC UpperDay 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622407|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|0.99||||81.34|2-Sided|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622408|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|0.99||||60.2|2-Sided|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622409|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|0.98||||85.95|2-Sided|95.0|0.94|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622410|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.02||||22.99|2-Sided|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622411|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.0||||47.44|2-Sided|95.0|0.96|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622964|NCT02289729|2979603|Other||Fisher's z|0.06326||||0.6546|2-Sided|95.0|-0.210715|0.327872|||Fisher's z Transformation|||SQLC with NBL A-S|
1622412|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.01||||36.28|2-Sided|95.0|0.97|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622413|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|0.99||||72.55|2-Sided|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622414|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.0||||62.63|2-Sided|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622415|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.0||||69.42|2-Sided|95.0|0.98|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622416|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.0||||63.78|2-Sided|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622417|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|0.99||||84.89|2-Sided|95.0|0.97|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622418|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.03||||10.86|2-Sided|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Total Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622419|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.02||||22.28|2-Sided|95.0|0.98|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Total Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622420|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.02||||18.58|2-Sided|95.0|0.97|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Lower Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622421|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.02||||21.87|2-Sided|95.0|0.97|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Lower Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622422|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.03||||9.83|2-Sided|95.0|0.99|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|FRC Region; Upper Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622423|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.01||||27.87|2-Sided|95.0|0.97|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Region; Upper Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622424|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.01||||28.28|2-Sided|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1623024|NCT02289729|2979636|Superiority||||||<|0.0001|||||||signed-rank test||||
1622425|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.01||||28.88|2-Sided|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622426|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.04||||7.66|2-Sided|95.0|0.99|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RLL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622427|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.03||||11.62|2-Sided|95.0|0.98|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RLL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622428|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.03||||12.19|2-Sided|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RML Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622429|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.02||||27.65|2-Sided|95.0|0.96|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RML Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622430|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.04||||6.73|2-Sided|95.0|0.99|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes;LUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622431|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.02||||15.91|2-Sided|95.0|0.98|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; LUL Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622432|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.04||||6.21|2-Sided|95.0|0.99|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RUL Day 28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622433|NCT02294734|2979078|Superiority or Other||Posterior Median Ratio|1.01||||32.51|2-Sided|95.0|0.97|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC Lobes; RUL; Day 12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622434|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.85||||98.66|2-Sided|95.0|0.73|0.98||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622435|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.0||||49.78|2-Sided|95.0|0.84|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622436|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.2||||1.17|2-Sided|95.0|1.02|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622437|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.76||||99.43|2-Sided|95.0|0.62|0.94||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622438|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.0||||49.97|2-Sided|95.0|0.76|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622439|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.31||||2.06|2-Sided|95.0|1.01|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622440|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.98||||62.84|2-Sided|95.0|0.89|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622441|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.04||||30.26|2-Sided|95.0|0.91|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622442|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.07||||14.5|2-Sided|95.0|0.95|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622443|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.75||||98.87|2-Sided|95.0|0.59|0.96||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622444|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.12||||23.67|2-Sided|95.0|0.81|1.56||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters.Unstructured covariance matrix fitted, accounting for correlation within region and visit|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622445|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.38||||2.29|2-Sided|95.0|1.01|1.89||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622446|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.85||||92.41|2-Sided|95.0|0.69|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622447|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.93||||73.09|2-Sided|95.0|0.72|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622448|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.22||||3.49|2-Sided|95.0|0.98|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622449|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.7||||99.2|2-Sided|95.0|0.52|0.94||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622766|NCT02294175|2979157|Superiority|||||||0.99|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).|
1622767|NCT02294175|2979158|Superiority|||||||0.993|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).|
1622450|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.04||||41.25|2-Sided|95.0|0.75|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622451|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.46||||0.88|2-Sided|95.0|1.06|2.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622452|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.86||||86.4|2-Sided|95.0|0.65|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622453|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.22||||13.92|2-Sided|95.0|0.85|1.73||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622454|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.42||||2.94|2-Sided|95.0|0.99|2.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622455|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.02||||45.69|2-Sided|95.0|0.75|1.37||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622456|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.22||||14.8|2-Sided|95.0|0.84|1.75||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622457|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.24||||8.67|2-Sided|95.0|0.91|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622458|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.88||||85.77|2-Sided|95.0|0.7|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622459|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.94||||66.85|2-Sided|95.0|0.71|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622460|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.13||||14.54|2-Sided|95.0|0.9|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622461|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.79||||96.49|2-Sided|95.0|0.61|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622768|NCT02294175|2979159|Superiority|||||||0.415|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).|
1622769|NCT02294175|2979160|Superiority|||||||0.999|||||||Kolmogorov-Smirnov Z|||Kolmogorov-Smirnov Z test was used as a non-parametric test to compare rank scores between treatment arms (similar to Mann-Whitney, but potentially more powerful).|
1622462|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.98||||55.09|2-Sided|95.0|0.75|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622463|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.19||||7.29|2-Sided|95.0|0.94|1.5||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622464|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.98||||56.53|2-Sided|95.0|0.77|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622465|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.86||||87.35|2-Sided|95.0|0.66|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622466|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.91||||77.2|2-Sided|95.0|0.7|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622467|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.25||||11.46|2-Sided|95.0|0.87|1.8||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622468|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.93||||65.66|2-Sided|95.0|0.64|1.36||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622469|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.01||||48.1|2-Sided|95.0|0.64|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622470|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.9||||82.11|2-Sided|95.0|0.72|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622471|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.81||||94.52|2-Sided|95.0|0.62|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622472|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.85||||91|2-Sided|95.0|0.67|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622473|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.07||||38.12|2-Sided|95.0|0.69|1.66||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622840|NCT02292433|2979295|Superiority or Other||LS Mean Difference|0.11|Standard Error of the Mean|0.156||0.5064|2-Sided|90.0|-0.17|0.39|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622474|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.92||||64.4|2-Sided|95.0|0.61|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622475|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.92||||61.12|2-Sided|95.0|0.53|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622476|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.19||||18.05|2-Sided|95.0|0.82|1.74||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622477|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.95||||61.06|2-Sided|95.0|0.65|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622478|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.01||||48.28|2-Sided|95.0|0.71|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622479|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.89||||71.95|2-Sided|95.0|0.6|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622480|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.91||||65.99|2-Sided|95.0|0.57|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622481|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.91||||63.71|2-Sided|95.0|0.51|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622482|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.89||||70.87|2-Sided|95.0|0.59|1.36||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622483|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.8||||87.99|2-Sided|95.0|0.55|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622484|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.94||||59.37|2-Sided|95.0|0.55|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622485|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.0||||50.1|2-Sided|95.0|0.66|1.54||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622841|NCT02292433|2979295|Superiority or Other||LS Mean Difference|0.03|Standard Error of the Mean|0.118||0.7877|2-Sided|90.0|-0.18|0.25|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622486|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.7||||95.35|2-Sided|95.0|0.46|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622487|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.14||||32.45|2-Sided|95.0|0.65|1.96||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622488|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.08||||34.93|2-Sided|95.0|0.73|1.57||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622489|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.82||||83.98|2-Sided|95.0|0.54|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622490|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.91||||70.12|2-Sided|95.0|0.63|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622491|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.95||||59.9|2-Sided|95.0|0.61|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622492|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|1.03||||44.8|2-Sided|95.0|0.66|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622493|NCT02294734|2979079|Superiority or Other||Posterior Median Ratio|0.92||||67.19|2-Sided|95.0|0.64|1.33||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures random effect|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622494|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.83||||99.19|2-Sided|95.0|0.72|0.97||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622495|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.97||||63.03|2-Sided|95.0|0.81|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622496|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.19||||1.9|2-Sided|95.0|1.01|1.4||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622497|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.75||||99.64|2-Sided|95.0|0.61|0.92||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622842|NCT02292433|2979295|Superiority or Other||LS Mean Difference|-0.17|Standard Error of the Mean|0.071||0.0282|2-Sided|90.0|-0.29|-0.05|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1623025|NCT02289729|2979637|Superiority|||||||0.0274|||||||signed-rank test||||
1622498|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.97||||58.48|2-Sided|95.0|0.73|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622499|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.29||||2.65|2-Sided|95.0|1.0|1.67||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622500|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.96||||78|2-Sided|95.0|0.86|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622501|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.0||||47.35|2-Sided|95.0|0.87|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622502|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.06||||18.91|2-Sided|95.0|0.93|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622503|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.72||||99.32|2-Sided|95.0|0.56|0.93||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622504|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.06||||36.75|2-Sided|95.0|0.76|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622505|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.33||||3.79|2-Sided|95.0|0.97|1.82||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622506|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.85||||93.29|2-Sided|95.0|0.68|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622507|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.92||||75.39|2-Sided|95.0|0.71|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622508|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.22||||3.1|2-Sided|95.0|0.99|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622509|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.68||||99.52|2-Sided|95.0|0.51|0.91||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622770|NCT02294175|2979161|Superiority|||||||0.979||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in IL6 over time varies according to treatment arm.|
1622510|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.0||||50.71|2-Sided|95.0|0.72|1.38||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622511|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.42||||1.64|2-Sided|95.0|1.03|1.95||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622512|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.81||||93|2-Sided|95.0|0.61|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622513|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.11||||28.82|2-Sided|95.0|0.77|1.6||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622514|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.36||||5.29|2-Sided|95.0|0.94|1.97||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622515|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.98||||55.06|2-Sided|95.0|0.73|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622516|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.15||||20.44|2-Sided|95.0|0.82|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622517|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.21||||9.64|2-Sided|95.0|0.91|1.62||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622518|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.86||||90.22|2-Sided|95.0|0.69|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622519|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.9||||75.69|2-Sided|95.0|0.68|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622520|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.13||||16.02|2-Sided|95.0|0.89|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622521|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.78||||97.39|2-Sided|95.0|0.6|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622771|NCT02294175|2979162|Superiority|||||||0.661||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether change in MMP-9 over time varies according to treatment arm.|
1622522|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.95||||66.4|2-Sided|95.0|0.74|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622523|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.17||||9.05|2-Sided|95.0|0.93|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622524|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.96||||63.42|2-Sided|95.0|0.75|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622525|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.82||||92.24|2-Sided|95.0|0.63|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622526|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.88||||84.87|2-Sided|95.0|0.68|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622527|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.21||||15.05|2-Sided|95.0|0.84|1.75||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622528|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.89||||72.31|2-Sided|95.0|0.61|1.3||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622529|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.97||||54.73|2-Sided|95.0|0.62|1.53||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622530|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.89||||85.41|2-Sided|95.0|0.7|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622531|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.77||||97.11|2-Sided|95.0|0.59|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622532|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.82||||94.93|2-Sided|95.0|0.65|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622533|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.03||||44.05|2-Sided|95.0|0.68|1.58||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622772|NCT02294175|2979163|Superiority|||||||0.397|||||||t-test, 2 sided||||
1622843|NCT02292433|2979295|Superiority or Other||LS Mean Difference|-0.21|Standard Error of the Mean|0.069||0.0067|2-Sided|90.0|-0.33|-0.09|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622534|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.86||||75.29|2-Sided|95.0|0.57|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622535|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.86||||69.91|2-Sided|95.0|0.5|1.5||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622536|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.16||||21.45|2-Sided|95.0|0.79|1.71||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; D12D28 . The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622537|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.92||||66.46|2-Sided|95.0|0.63|1.35||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622538|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.98||||54.22|2-Sided|95.0|0.69|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622539|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.87||||75.82|2-Sided|95.0|0.59|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622540|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.86||||73.67|2-Sided|95.0|0.54|1.37||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622541|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.87||||69.29|2-Sided|95.0|0.5|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622542|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.83||||81.07|2-Sided|95.0|0.55|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622543|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.73||||94.41|2-Sided|95.0|0.5|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622544|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.85||||72.81|2-Sided|95.0|0.51|1.44||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622545|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.0||||50.74|2-Sided|95.0|0.67|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622773|NCT02294175|2979164|Superiority|||||||0.012||||||Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.|
1622546|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.7||||95.74|2-Sided|95.0|0.47|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622547|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.1||||36.1|2-Sided|95.0|0.64|1.91||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622548|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|1.03||||43.88|2-Sided|95.0|0.7|1.51||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622549|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.77||||89.98|2-Sided|95.0|0.51|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622550|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.85||||81.67|2-Sided|95.0|0.59|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622551|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.92||||65.66|2-Sided|95.0|0.6|1.4||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622552|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.99||||51.75|2-Sided|95.0|0.65|1.53||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622553|NCT02294734|2979080|Superiority or Other||Posterior Median Ratio|0.95||||60.07|2-Sided|95.0|0.66|1.39||The data entered for the p-value represents the posterior probability that the true treatment ratio is less than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622554|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.01||||78.09|2-Sided|95.0|0.98|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622555|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.99||||32.84|2-Sided|95.0|0.95|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622556|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.98||||13.52|2-Sided|95.0|0.94|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622557|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.04||||86.41|2-Sided|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622812|NCT02292771|2979248|Superiority||Odds Ratio (OR)|2.3||||0.1432|2-Sided|95.0|0.75|7.24|||Regression, Logistic||||
1622813|NCT02292771|2979249|Superiority||Odds Ratio (OR)|1.2||||0.6646|2-Sided|95.0|0.51|2.9|||Regression, Logistic||||
1622814|NCT02292771|2979250|Superiority||Odds Ratio (OR)|0.8||||0.779|2-Sided|95.0|0.12|4.84|||Regression, Logistic||||
1622558|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.98||||35.88|2-Sided|95.0|0.89|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622559|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.94||||5.93|2-Sided|95.0|0.86|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622560|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.0||||58.42|2-Sided|95.0|0.98|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622561|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.99||||34.15|2-Sided|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622562|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.99||||27.33|2-Sided|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622563|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.07||||93.33|2-Sided|95.0|0.98|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622564|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.99||||42.13|2-Sided|95.0|0.89|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622565|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.92||||4.64|2-Sided|95.0|0.83|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622566|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.02||||73.03|2-Sided|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622567|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.98||||30.03|2-Sided|95.0|0.89|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622568|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.95||||9.54|2-Sided|95.0|0.88|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622569|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.0||||51.44|2-Sided|95.0|0.95|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622815|NCT02292771|2979256|Superiority||Odds Ratio (OR)|1.9||||0.5066|2-Sided|95.0|0.3|11.71|||Regression, Logistic||||
1622816|NCT02292771|2979257|Superiority||Ratio|1.14|Standard Error of the Mean|0.222||0.5672|2-Sided|95.0|0.73|1.76|||ANCOVA||||
1622817|NCT02292771|2979258|Superiority||Odds Ratio (OR)|1.0||||0.952|2-Sided|95.0|0.46|2.29|||Regression, Logistic||||
1622570|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.97||||11.82|2-Sided|95.0|0.93|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622571|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.02||||62.87|2-Sided|95.0|0.9|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622572|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.92||||10.14|2-Sided|95.0|0.82|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622573|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.0||||44.1|2-Sided|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622574|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.99||||25.61|2-Sided|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622575|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.04||||70.73|2-Sided|95.0|0.89|1.22||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622576|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.9||||9.67|2-Sided|95.0|0.77|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622577|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.01||||57.82|2-Sided|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model.|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D28.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622578|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.96||||23.27|2-Sided|95.0|0.87|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622579|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.05||||87.39|2-Sided|95.0|0.97|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622580|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.97||||28.82|2-Sided|95.0|0.86|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622581|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.92||||6.38|2-Sided|95.0|0.83|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622818|NCT02292771|2979259|Superiority||Odds Ratio (OR)|1.0||||0.952|2-Sided|95.0|0.44|2.18|||Regression, Logistic||||
1622819|NCT02292771|2979260|Superiority||Mean Difference (Final Values)|-1.2||||0.3797|2-Sided|95.0|-8.879|6.479|||Finite mixture model||||
1622820|NCT02292758|2979263|Superiority|||||||0.5262|||||||Wilcoxon (Mann-Whitney)|||Irinotecan comparison|
1622582|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.09||||95.24|2-Sided|95.0|0.99|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622583|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.99||||42.22|2-Sided|95.0|0.88|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622584|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.91||||3.3|2-Sided|95.0|0.81|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12.The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622585|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.05||||80.61|2-Sided|95.0|0.95|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622586|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.94||||14.15|2-Sided|95.0|0.85|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622587|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.89||||1.95|2-Sided|95.0|0.81|0.99||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622588|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.0||||48.45|2-Sided|95.0|0.91|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622589|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.97||||24.36|2-Sided|95.0|0.88|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622590|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.97||||25.65|2-Sided|95.0|0.89|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622591|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.04||||80.34|2-Sided|95.0|0.95|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622592|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.97||||30.03|2-Sided|95.0|0.89|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622593|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.93||||4.03|2-Sided|95.0|0.86|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622821|NCT02292758|2979263|Superiority|||||||0.4283|||||||Wilcoxon (Mann-Whitney)|||Cetuximab comparison|
1622822|NCT02292758|2979264|Superiority||Hazard Ratio (HR)|0.755||||0.3738|2-Sided|95.0|0.345|1.655|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)||
1622823|NCT02292758|2979265|Superiority|||||||0.447|||||||Log Rank||||
1622594|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.03||||63.15|2-Sided|95.0|0.87|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622595|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.9||||9.87|2-Sided|95.0|0.76|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622596|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.08||||81.73|2-Sided|95.0|0.91|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622597|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.95||||25.21|2-Sided|95.0|0.8|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622598|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.98||||38.43|2-Sided|95.0|0.84|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622599|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.95||||28.14|2-Sided|95.0|0.78|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622600|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.05||||75.23|2-Sided|95.0|0.92|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622601|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.02||||60.75|2-Sided|95.0|0.9|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622602|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.0||||52.99|2-Sided|95.0|0.89|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622603|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.94||||13.08|2-Sided|95.0|0.85|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622604|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.0||||56.99|2-Sided|95.0|0.95|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622605|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.06||||96.58|2-Sided|95.0|1.0|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622824|NCT02292758|2979266|Superiority|||||||0.1279|||||||Fisher Exact||||
1622825|NCT02292758|2979267|Superiority|||||||0.3415|||||||Chi-squared||||
1622826|NCT02292758|2979269|Superiority||Hazard Ratio (HR)|0.406|||||2-Sided|95.0|0.151|1.089|||||Adjusted HR; Model adjusted by: age, gender, race (white vs others), number of metastatic sites (1 vs 2 vs 3+), ECOG PS (0 vs 1), tumor site (colon, rectum/rectosigmoid, multiple)||
1622606|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.05||||93.68|2-Sided|95.0|0.98|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622607|NCT02294734|2979081|Superiority or Other||Bayesian repeated measures model|1.08||||95.09|2-Sided|95.0|0.99|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622608|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.13||||98.29|2-Sided|95.0|1.01|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622609|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.03||||71.55|2-Sided|95.0|0.92|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622610|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.0||||47.62|2-Sided|95.0|0.94|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622611|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.06||||96.27|2-Sided|95.0|0.99|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622612|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.06||||95.29|2-Sided|95.0|0.99|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622613|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.05||||79.8|2-Sided|95.0|0.94|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622614|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.12||||95.83|2-Sided|95.0|0.99|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622615|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.05||||75.74|2-Sided|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622616|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.08||||94.07|2-Sided|95.0|0.98|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622617|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.13||||98.19|2-Sided|95.0|1.01|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622827|NCT02292758|2979269|Superiority||Hazard Ratio (HR)|0.471||||0.0446|2-Sided|95.0|0.209|1.062|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)||
1623026|NCT02289729|2979638|Superiority||||||<|0.0001|||||||signed-rank test||||
1622618|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.03||||68.89|2-Sided|95.0|0.92|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622619|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.06||||91.54|2-Sided|95.0|0.97|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622620|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.06||||87.8|2-Sided|95.0|0.96|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622621|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.23||||98.25|2-Sided|95.0|1.02|1.48||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622622|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.07||||74.67|2-Sided|95.0|0.87|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622623|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.05||||89.3|2-Sided|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622624|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.07||||91.11|2-Sided|95.0|0.97|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622625|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.23||||96.8|2-Sided|95.0|0.99|1.52||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622626|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.11||||78.24|2-Sided|95.0|0.86|1.43||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622627|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.22||||98.44|2-Sided|95.0|1.02|1.47||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622628|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.06||||72.55|2-Sided|95.0|0.88|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622629|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.06||||82.15|2-Sided|95.0|0.94|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622828|NCT02292758|2979272|Superiority||Hazard Ratio (HR)|0.642|||||2-Sided|95.0|0.249|1.656|||||Adjusted HR; Model adjusted by: age, gender, race (white vs others), number of metastatic sites (1 vs 2 vs 3+), ECOG PS (0 vs 1), tumor site (colon, rectum/rectosigmoid, multiple)||
1623027|NCT02289729|2979639|Superiority|||||||0.0038|||||||t-test||||
1622630|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.08||||85.3|2-Sided|95.0|0.94|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622631|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.04||||71.94|2-Sided|95.0|0.91|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622632|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.14||||97.8|2-Sided|95.0|1.0|1.3||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622633|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.22||||99.54|2-Sided|95.0|1.05|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622634|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.07||||79.13|2-Sided|95.0|0.9|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622635|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.14||||96.57|2-Sided|95.0|0.99|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622636|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.15||||97.17|2-Sided|95.0|1.0|1.32||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622637|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.01||||55.32|2-Sided|95.0|0.88|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622638|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.08||||91.94|2-Sided|95.0|0.97|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622639|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.16||||98.89|2-Sided|95.0|1.02|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622640|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.07||||86.18|2-Sided|95.0|0.95|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622641|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.1||||96.86|2-Sided|95.0|0.99|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622829|NCT02292758|2979272|Superiority||Hazard Ratio (HR)|0.912||||0.7609|2-Sided|95.0|0.431|1.93|||Log Rank||Unadjusted HR; Model stratified by: prior bevacizumab (Y vs N) and prior lines of chemotherapy (1 vs 2+)||
1623028|NCT02289729|2979640|Superiority||||||<|0.0001|||||||t-test||||
1622642|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.14||||98.35|2-Sided|95.0|1.01|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622643|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.02||||67.37|2-Sided|95.0|0.92|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622644|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.13||||86.82|2-Sided|95.0|0.91|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622645|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.02||||58.8|2-Sided|95.0|0.82|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622646|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.38||||99.01|2-Sided|95.0|1.05|1.81||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622647|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.25||||92.6|2-Sided|95.0|0.92|1.7||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622648|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.29||||98.3|2-Sided|95.0|1.02|1.64||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622649|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|0.99||||46.24|2-Sided|95.0|0.75|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622650|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.31||||99.22|2-Sided|95.0|1.06|1.61||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622651|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.1||||82.27|2-Sided|95.0|0.9|1.33||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622652|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.18||||94.01|2-Sided|95.0|0.96|1.46||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|(FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622653|NCT02294734|2979081|Superiority or Other||Posterior Median Ratio|1.02||||59.55|2-Sided|95.0|0.84|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|(FRC; Longitudinal; Lobes; RUL; D12, The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622830|NCT02292537|2979284|Superiority||Difference in Proportions|1.5|||||2-Sided|95.0|-19.1|22.1|||||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.||
1622831|NCT02292537|2979285|Superiority||Difference in Proportions|-1.4|||||2-Sided|95.0|-21.84|19.34|||||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.||
1622654|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.0||||55.52|2-Sided|95.0|0.97|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622655|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.99||||24.49|2-Sided|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622656|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.98||||21.87|2-Sided|95.0|0.95|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622657|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.03||||81.15|2-Sided|95.0|0.96|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622658|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.98||||32.91|2-Sided|95.0|0.9|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region; Distal; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622659|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.94||||7.13|2-Sided|95.0|0.87|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622660|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.99||||29.89|2-Sided|95.0|0.97|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622661|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.99||||24.88|2-Sided|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622662|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.0||||41.38|2-Sided|95.0|0.96|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622663|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.05||||86.07|2-Sided|95.0|0.97|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622664|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.98||||33.63|2-Sided|95.0|0.89|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622665|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.93||||6.1|2-Sided|95.0|0.84|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622832|NCT02292537|2979286|Superiority||LS Mean Differenec|3.7|||||2-Sided|95.0|2.3|5.0|||||From multiple imputation procedure, based on ANCOVA with treatment as a fixed effect and adjustment for each participant's age at screening and derived total score at baseline.||
1622958|NCT02289729|2979603|Other||Fisher's z|0.01625||||0.9076|2-Sided|95.0|-0.252613|0.282777|||Fisher's z Transformation|||SQLC with Global NMSS|
1622666|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.02||||69.92|2-Sided|95.0|0.95|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622667|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.98||||32.29|2-Sided|95.0|0.91|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD28 The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622668|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.96||||12.63|2-Sided|95.0|0.89|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622669|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.99||||29.88|2-Sided|95.0|0.95|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622670|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.97||||10|2-Sided|95.0|0.93|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622671|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.01||||57.39|2-Sided|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622672|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.92||||8.12|2-Sided|95.0|0.82|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622673|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.99||||18.15|2-Sided|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal;Region; Cetral; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622674|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.99||||25.44|2-Sided|95.0|0.96|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622675|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.01||||55.85|2-Sided|95.0|0.88|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622676|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.89||||6.22|2-Sided|95.0|0.76|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622677|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.01||||58.17|2-Sided|95.0|0.91|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622833|NCT02292537|2979287|Superiority||LS Mean Difference|0.4|||||2-Sided|95.0|0.2|0.7|||||Based on ANCOVA with treatment as a fixed effect and adjustment for each participant's age at screening and number of milestones at baseline.||
1622959|NCT02289729|2979603|Other||Fisher's z|0.17846||||0.2025|2-Sided|95.0|-0.095693|0.424291|||Fisher's z Transformation|||SQLC with UPDRS-IV|
1622678|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.96||||22.54|2-Sided|95.0|0.87|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622679|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.03||||76.16|2-Sided|95.0|0.95|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622680|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.96||||23.39|2-Sided|95.0|0.87|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622681|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.93||||7.9|2-Sided|95.0|0.84|1.03||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622682|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.06||||87.6|2-Sided|95.0|0.96|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622683|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.96||||20.83|2-Sided|95.0|0.86|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622684|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.9||||3.23|2-Sided|95.0|0.81|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622685|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.02||||66.6|2-Sided|95.0|0.92|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622686|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.92||||6.09|2-Sided|95.0|0.83|1.02||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622687|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.89||||2.21|2-Sided|95.0|0.8|1.0||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622688|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.99||||44.94|2-Sided|95.0|0.92|1.08||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622689|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.96||||18.58|2-Sided|95.0|0.88|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622834|NCT02292537|2979288|Superiority||Difference in Proportions|13.8||||0.0811|2-Sided|95.0|-6.64|34.17|||Fisher Exact||Difference in proportions of Nusinersen minus Sham Procedure is based on exact unconditional confidence interval.||
1622960|NCT02289729|2979603|Other||Fisher's z|-0.13433||||0.3374|2-Sided|95.0|-0.387439|0.139207|||Fisher's z Transformation|||SQLC with UPDRS-III|
1622690|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.97||||23.07|2-Sided|95.0|0.89|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622691|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.03||||77.08|2-Sided|95.0|0.95|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622692|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.97||||24.79|2-Sided|95.0|0.89|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622693|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.93||||4.03|2-Sided|95.0|0.87|1.01||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622694|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.01||||56.35|2-Sided|95.0|0.87|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622695|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.89||||7.44|2-Sided|95.0|0.76|1.04||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LLL; D12 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622696|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.0||||50.4|2-Sided|95.0|0.86|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622697|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.89||||0.89|2-Sided|95.0|0.75|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622698|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.92||||16.95|2-Sided|95.0|0.78|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622699|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.88||||9.12|2-Sided|95.0|0.72|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622700|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.03||||66.48|2-Sided|95.0|0.91|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622701|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.0||||52.25|2-Sided|95.0|0.9|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622835|NCT02292537|2979289|Superiority||Difference in Proportions|30.5|||||2-Sided|95.0|12.74|48.31|||||Difference in proportions of Nusinersen minus Sham Procedure are from multiple imputation procedure and are based on binomial proportions.||
1622961|NCT02289729|2979603|Other||Fisher's z|-0.36687||||0.0088|2-Sided|95.0|-0.565795|-0.092154|||Fisher's z Transformation|||SQLC with Global PDQ-39|
1622702|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.0||||48.69|2-Sided|95.0|0.9|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622703|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.95||||15.85|2-Sided|95.0|0.86|1.05||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|TLC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622704|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.0||||52.58|2-Sided|95.0|0.94|1.07||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed;Region;Total; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622705|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.03||||81.04|2-Sided|95.0|0.96|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Total; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622706|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.03||||73.7|2-Sided|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Total; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622707|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.08||||93.16|2-Sided|95.0|0.98|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Distal; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622708|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.1||||94.51|2-Sided|95.0|0.98|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region; Distal; SCRD28 .The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622709|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.0||||52.79|2-Sided|95.0|0.89|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region;Distal; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622710|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.0||||44.15|2-Sided|95.0|0.93|1.06||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region Central; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622711|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.03||||78.42|2-Sided|95.0|0.96|1.1||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed; Region Central; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622712|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.03||||77.07|2-Sided|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC;Scan Trimmed;Region;Central; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622713|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.05||||77.57|2-Sided|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622836|NCT02292537|2979289|Superiority||Odds Ratio (OR)|5.59||||0.0006|2-Sided|95.0|2.09|14.91||Based on multiple imputation and logistic regression with treatment effect and adjustment for each participant's age at screening and HFMSE score at baseline.|Regression, Logistic||||
1623029|NCT02289729|2979641|Superiority|||||||0.0002|||||||signed-rank test||||
1622714|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.08||||87.93|2-Sided|95.0|0.95|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region; Lower; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622715|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.01||||54.65|2-Sided|95.0|0.88|1.16||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Lower; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622716|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.07||||92.27|2-Sided|95.0|0.97|1.18||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622717|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.1||||95.02|2-Sided|95.0|0.98|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622718|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.01||||53.85|2-Sided|95.0|0.9|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Region;Upper; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622719|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.03||||74.38|2-Sided|95.0|0.95|1.11||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Total; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622720|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.03||||72.17|2-Sided|95.0|0.93|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Total; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622721|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.18||||96.47|2-Sided|95.0|0.99|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622722|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.04||||63.91|2-Sided|95.0|0.85|1.27||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Distal; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622723|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.02||||67.01|2-Sided|95.0|0.95|1.09||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Central; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622724|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.03||||76.81|2-Sided|95.0|0.94|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region;Central; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622725|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.15||||91.99|2-Sided|95.0|0.94|1.41||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622837|NCT02292537|2979290|Superiority||LS Mean Difference|4.9|Standard Error of the Mean|0.91||1e-07|2-Sided|95.0|3.1|6.7|||ANCOVA|ANCOVA model with treatment group as a factor and age at Screening and baseline HFMSE score as covariates.|||
1623030|NCT02289729|2979642|Superiority||||||<|0.0001|||||||t-test||||
1622726|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.05||||63.99|2-Sided|95.0|0.81|1.34||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Lower; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622727|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.19||||97.15|2-Sided|95.0|0.99|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Region; Upper; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622728|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.04||||65.43|2-Sided|95.0|0.87|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal;Region; Upper; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622729|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.04||||74.15|2-Sided|95.0|0.92|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622730|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.04||||70.84|2-Sided|95.0|0.91|1.19||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622731|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.01||||53.24|2-Sided|95.0|0.87|1.17||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622732|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.12||||94.02|2-Sided|95.0|0.97|1.29||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622733|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.15||||96.63|2-Sided|95.0|0.99|1.34||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.No|FRC; Scan Trimmed; Lobes; RLL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622734|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.03||||61.27|2-Sided|95.0|0.86|1.23||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RLL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622735|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.13||||94.59|2-Sided|95.0|0.97|1.31||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622736|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.12||||94.51|2-Sided|95.0|0.98|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622737|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.0||||48.99|2-Sided|95.0|0.86|1.15||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RML; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622838|NCT02292433|2979295|Superiority or Other||LS Mean Difference|-0.45|Standard Error of the Mean|0.295||0.1422|2-Sided|90.0|-0.95|0.06|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622738|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.09||||94.16|2-Sided|95.0|0.98|1.2||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622739|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.12||||96.86|2-Sided|95.0|0.99|1.26||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622740|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.02||||62.95|2-Sided|95.0|0.91|1.14||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; LUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622741|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.09||||94.09|2-Sided|95.0|0.98|1.21||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; D12D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622742|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.1||||94.45|2-Sided|95.0|0.98|1.24||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622743|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.01||||54.89|2-Sided|95.0|0.9|1.12||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Scan Trimmed; Lobes; RUL; SCRD12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622744|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.15||||90.66|2-Sided|95.0|0.93|1.42||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622745|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.0||||51.27|2-Sided|95.0|0.81|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622746|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.3||||97.79|2-Sided|95.0|1.01|1.66||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622747|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.14||||80.24|2-Sided|95.0|0.84|1.54||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RLL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622748|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.28||||97.92|2-Sided|95.0|1.01|1.62||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622749|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|0.87||||13.98|2-Sided|95.0|0.66|1.13||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RML; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622839|NCT02292433|2979295|Superiority or Other||LS Mean Difference|-0.25|Standard Error of the Mean|0.293||0.4072|2-Sided|90.0|-0.75|0.25|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1623031|NCT02289729|2979643|Superiority|||||||0.0002|||||||t-test||||
1622750|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.29||||99.48|2-Sided|95.0|1.06|1.58||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622751|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.06||||74.29|2-Sided|95.0|0.88|1.28||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; LUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622752|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.19||||95.21|2-Sided|95.0|0.97|1.47||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RUL; D28. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622753|NCT02294734|2979082|Superiority or Other||Posterior Median Ratio|1.03||||60.66|2-Sided|95.0|0.85|1.25||The data entered for the p-value represents the posterior probability that the true treatment ratio is greater than 1. P-value is denoted in percentage.|Bayesian repeated measures model|Non-informative priors used for all modelling parameters. Unstructured covariance matrix fitted, accounting for correlation within region and visit.|FRC; Longitudinal; Lobes; RUL; D12. The data entered to the 95% confidence interval represents the 95% equi-tailed credible interval.||
1622754|NCT02294682|2979100|Superiority or Other||Microbio Response Urogenital Gonorrhea|95.0|||||1-Sided|95.0|84.7||||||GSK2140944 3000 mg||
1622755|NCT02294682|2979100|Superiority or Other||Microbio Response Urogenital Gonorrhea|97.0|||||1-Sided|95.0|85.1||||||GSK2140944 1500 mg||
1622756|NCT02294474|2979113|Non-Inferiority|Non-inferiority of SAR342434 over Humalog was demonstrated if upper bound of 2-sided 95% confidence interval(CI) of difference between SAR342434 & Humalog was <0.3%.Inverse non-inferiority of Humalog over SAR342434 was tested using hierarchical step-down testing procedure: if non-inferiority of SAR342434 over Humalog was demonstrated,then inverse non-inferiority of Humalog over SAR342434 was tested and demonstrated if lower bound of 2-sided 95% CI of difference between SAR342434 & Humalog>-0.3%.|Least Square (LS) Mean Difference|-0.07|Standard Error of the Mean|0.072|||2-Sided|95.0|-0.215|0.067|||||SAR342434 vs. Humalog|Analysis was performed using a MMRM approach with treatment groups, randomization strata, visit (Week 12, Week 26) and treatment-by-visit interaction as fixed categorical effects and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-participant errors.|
1622757|NCT02294461|2979123|Superiority or Other (legacy)||Difference in objective response rate|26.0|||<|0.0001|2-Sided|95.0|14.7|37.4||P-value is based on unstratified Cochran-Mantel-Haenszel mean score test.|Unstratified Cochran-Mantel-Haenszel|||When deriving the response category, it was based on the target, non-target and new lesions without confirming CR, PR, and Progressive disease (PD). Participants with no post baseline assessment were included in the category of Nonevaluable (NE). The best overall soft tissue objective response was defined as PR or CR based on the investigator assessments of target, non-target and new lesions while on the study treatment.|
1622758|NCT02294461|2979124|Superiority or Other (legacy)||Difference of response rate|55.8|||<|0.0001|2-Sided|95.0|47.4|64.2||P-value is based on unstratified Cochran-Mantel-Haenszel mean score test.|Unstratified Cochran-Mantel-Haenszel %||||
1622759|NCT02294461|2979125|Superiority or Other (legacy)||Hazard Ratio (HR)|0.28||||0.002||95.0|0.12|0.66||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who did not start cytotoxic chemotherapy at the time of analysis data cutoff were censored at the date of the last assessment indicating no evidence of cytotoxic chemotherapy usage. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.|
1622760|NCT02294461|2979126|Superiority or Other (legacy)||Hazard Ratio (HR)|0.56||||0.2501|2-Sided|95.0|0.21|1.52||P-value was based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who did not have an SRE at the time of analysis data cutoff were censored at the date of the last assessment indicating no evidence of SRE. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.|
1622761|NCT02294461|2979127|Superiority or Other (legacy)||Hazard Ratio (HR)|0.31|||<|0.0001||95.0|0.2|0.46||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who were not known to have had an rPFS event at the time of data cutoff were censored at the date of the last assessment showing no objective evidence of rPFS prior to scan modality change, new antineoplastic treatment, initiation of radiation therapy for prostate cancer, skeletal-related event (SRE) and 2 or more consecutive missed tumor assessments. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide.|
1622762|NCT02294461|2979128|Superiority or Other (legacy)||Hazard Ratio (HR)|0.33||||0.0015|2-Sided|95.0|0.16|0.67||P-value is based on an unstratified log-rank test.|Unstratified log-rank test|||Participants who were not known to have had died at the analysis date were censored at date last known alive or data analysis cutoff date, whichever occurred first. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.|
1622763|NCT02294461|2979129|Superiority or Other (legacy)||Unstratified Cox Proportional Hazards|0.38|||<|0.0001|2-Sided|95.0|0.27|0.52|||Hazard Ratio|||P-value is based on an unstratified log-rank test. Hazard ratio calculated using unstratified Cox Proportional Hazards model with treatment as the only covariate for enzalutamide group versus placebo group.|
1622764|NCT02294227|2979156|Superiority||Odds Ratio (OR)|3.24||||0.0003|2-Sided|95.0|1.76|5.97|||Chi-squared, Corrected||||
1622765|NCT02294227|2979156|Superiority||Odds Ratio (OR)|3.07||||0.0002|2-Sided|95.0|1.66|5.66|||Chi-squared||||
1622774|NCT02294175|2979165|Superiority|||||||0.037||||||Repeated Measures ANOVA. This interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p<.05 for Mauchly's W).||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.|
1622775|NCT02294175|2979166|Superiority|||||||0.029||||||Repeated Measures ANOVA. The interaction effect is controlling for any potential main effects of treatment arm (SDT vs LDT) and time (days 0, 4, 8).|Repeated Measures ANOVA|Greenhouse-Geisser corrections were applied to the F test degrees of freedom due to violation of the sphericity assumption (p<.05 for Mauchly's W).||Repeated Measures Analysis of Variance (RMANOVA) to test for effects of treatment arm, time, and treatment-by-time interaction. The effect of interest is the treatment-by-time interaction, i.e, whether the reduction of bacterial CFUs over time varies according to treatment arm.|
1622776|NCT02293902|2979177|Superiority||Odds Ratio (OR)|7.227|||<|0.0001|2-Sided|95.0|3.446|15.158||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using CMH test stratified by prior biologic use (Yes, No) and weight at screening (<55 kg, >=55 kg).|Placebo vs. Sarilumab 200 mg
1622777|NCT02293902|2979177|Superiority||Odds Ratio (OR)|12.185|||<|0.0001|2-Sided|95.0|5.583|26.594||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test stratified by prior biologic use (Yes, No) and weight at screening (<55 kg, >=55 kg).|Placebo vs. Sarilumab 150 mg
1622778|NCT02293863|2979183|Other||Hazard Ratio (HR)|0.58||||0.2522|2-Sided|80.0|0.36|0.96|||Wilcoxon (Mann-Whitney)||||
1622779|NCT02293863|2979183|Other||Hazard Ratio (HR)|0.66||||0.7827|2-Sided|80.0|0.41|1.07|||Wilcoxon (Mann-Whitney)||||
1622780|NCT02293863|2979184|Other||Difference in event rates|-1.85||||0.3667|2-Sided|80.0|-9.88|6.18|||Cochran-Mantel-Haenszel||||
1622781|NCT02293863|2979184|Other||Difference in event rates|1.99||||0.5379|2-Sided|80.0|-5.57|9.56|||Cochran-Mantel-Haenszel||||
1622782|NCT02293863|2979185|Other||Difference in event rates|0.67||||0.9225|2-Sided|80.0|-9.29|10.64|||Cochran-Mantel-Haenszel||||
1622783|NCT02293863|2979185|Other||Difference in event rates|2.42||||0.7219|2-Sided|80.0|-6.96|11.8|||Cochran-Mantel-Haenszel||||
1622784|NCT02293863|2979186|Other||Difference in event rates|-1.6||||0.8111|2-Sided|80.0|-11.48|8.28|||Cochran-Mantel-Haenszel||||
1622785|NCT02293863|2979186|Other||Difference in event rates|-1.42||||0.824|2-Sided|80.0|-10.61|7.76|||Cochran-Mantel-Haenszel||||
1622786|NCT02293863|2979187|Other||Hazard Ratio (HR)|0.9||||0.8322|2-Sided|80.0|0.61|1.34|||Wilcoxon (Mann-Whitney)||||
1622787|NCT02293863|2979187|Other||Hazard Ratio (HR)|0.7||||0.4171|2-Sided|80.0|0.47|1.03|||Wilcoxon (Mann-Whitney)||||
1622788|NCT02293863|2979188|Other||Hazard Ratio (HR)|1.05||||0.5447|2-Sided|80.0|0.8|1.38|||Wilcoxon (Mann-Whitney)||||
1622789|NCT02293863|2979188|Other||Hazard Ratio (HR)|1.01||||0.8806|2-Sided|80.0|0.78|1.32|||Wilcoxon (Mann-Whitney)||||
1622790|NCT02293863|2979189|Other||Hazard Ratio (HR)|1.32||||0.4763|2-Sided|80.0|0.99|1.77|||Wilcoxon (Mann-Whitney)||||
1622791|NCT02293863|2979189|Other||Hazard Ratio (HR)|1.01||||0.7413|2-Sided|80.0|0.77|1.32|||Wilcoxon (Mann-Whitney)||||
1622792|NCT02293863|2979190|Other||Mean Difference (Final Values)|-0.42||||0.1909|2-Sided|80.0|-0.7|-0.15|||ANOVA||||
1622793|NCT02293863|2979190|Other||Mean Difference (Final Values)|-0.33||||0.279|2-Sided|80.0|-0.6|-0.07|||ANOVA||||
1622794|NCT02293863|2979191|Other||Mean Difference (Final Values)|-0.7||||0.8339|2-Sided|80.0|-3.49|2.1|||ANOVA||||
1622795|NCT02293863|2979191|Other||Mean Difference (Final Values)|-3.73||||0.2407|2-Sided|80.0|-6.41|-1.06|||ANOVA||||
1622796|NCT02293863|2979192|Other||Difference in event rates|1.68||||0.7633|2-Sided|80.0|-7.38|10.74|||Cochran-Mantel-Haenszel|||Day 60|
1622797|NCT02293863|2979192|Other||Difference in event rates|2.21||||0.6849|2-Sided|80.0|-6.28|10.69|||Cochran-Mantel-Haenszel|||Day 60|
1622798|NCT02293863|2979192|Other||Difference in event rates|3.54||||0.5013|2-Sided|80.0|-5.24|12.31|||Cochran-Mantel-Haenszel|||Day 30|
1622799|NCT02293863|2979192|Other||Difference in event rates|2.14||||0.6594|2-Sided|80.0|-6.04|10.31|||Cochran-Mantel-Haenszel|||Day 30|
1622800|NCT02293863|2979192|Other||Difference in event rates|4.97||||0.2189|2-Sided|80.0|-3.12|13.05|||Cochran-Mantel-Haenszel|||Day 14|
1622801|NCT02293863|2979192|Other||Difference in event rates|1.99||||0.5379|2-Sided|80.0|-5.57|9.56|||Cochran-Mantel-Haenszel|||Day 14|
1622802|NCT02293863|2979193|Other||Difference in event rates|-14.58||||0.3865|2-Sided|80.0|-36.13|6.97|||Cochran-Mantel-Haenszel||||
1622803|NCT02293863|2979193|Other||Difference in event rates|-7.92||||0.6043|2-Sided|80.0|-27.5|11.66|||Cochran-Mantel-Haenszel||||
1622804|NCT02293863|2979194|Other||Difference in event rates|7.91||||0.3168|2-Sided|80.0|-2.64|18.47|||Cochran-Mantel-Haenszel||||
1622805|NCT02293863|2979194|Other||Difference in event rates|10.19||||0.1905|2-Sided|80.0|-0.15|20.52|||Cochran-Mantel-Haenszel||||
1622806|NCT02293863|2979196|Other||Hazard Ratio (HR)|1.13||||0.2028|2-Sided|80.0|0.85|1.51|||Wilcoxon (Mann-Whitney)||||
1622807|NCT02293863|2979196|Other||Hazard Ratio (HR)|1.08||||0.605|2-Sided|80.0|0.83|1.4|||Wilcoxon (Mann-Whitney)||||
1622808|NCT02293460|2979206|Superiority|The response rate was tested against the historical response rate of 33.3%.|Responder rate|76.2|||<|0.0001|2-Sided|95.0|60.5|87.9||One-sided test at nominal level of significance alpha = 2.5 %|exact binomial Clopper-Pearson|||"For this single-arm study, the response rate was tested against the historical response rate of 33.3% with a 1-sided Clopper-Pearson exact test at the nominal level of significance of 2.5% on the Full Analysis Set. The null and alternative hypotheses were as follows:~H0: pI10E <= 33.3% H1: pI10E > 33.3%"|
1622809|NCT02293395|2979207|Superiority or Other||Hazard Ratio (HR)|1.09||||0.584|2-Sided|95.0|0.8|1.5|||Log Rank||||
1622810|NCT02292771|2979246|Superiority||Odds Ratio (OR)|0.6||||0.4682|2-Sided|95.0|0.13|2.58|||Regression, Logistic||||
1622811|NCT02292771|2979247|Superiority||Odds Ratio (OR)|1.5||||0.525|2-Sided|95.0|0.43|5.15|||Regression, Logistic||||
1622844|NCT02292433|2979296|Superiority or Other||LS Mean Difference|-3.766|Standard Error of the Mean|1.5951||0.0254|2-Sided|90.0|-6.479|-1.052|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622845|NCT02292433|2979296|Superiority or Other||LS Mean Difference|-1.358|Standard Error of the Mean|1.5994||0.4031|2-Sided|90.0|-4.079|1.363|||Mixed Models Analysis|||Analysis for pre-dinner. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622846|NCT02292433|2979296|Superiority or Other||LS Mean Difference|-2.439|Standard Error of the Mean|0.9533||0.0659|2-Sided|90.0|-4.502|-0.377|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622847|NCT02292433|2979296|Superiority or Other||LS Mean Difference|-0.967|Standard Error of the Mean|2.3324||0.6873|2-Sided|90.0|-5.195|3.261|||Mixed Models Analysis|||Analysis for pre-lunch. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622848|NCT02292433|2979296|Superiority or Other||LS Mean Difference|-1.949|Standard Error of the Mean|0.7249||0.0119|2-Sided|90.0|-3.183|-0.716|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622849|NCT02292433|2979296|Superiority or Other||LS Mean Difference|-1.521|Standard Error of the Mean|0.7237||0.0447|2-Sided|90.0|-2.752|-0.29|||Mixed Models Analysis|||Analysis for pre-breakfast. Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622850|NCT02292433|2979297|Superiority or Other||LS Mean Difference|-25.81|Standard Error of the Mean|2.821|<|0.0001|2-Sided|90.0|-30.73|-20.88|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622851|NCT02292433|2979297|Superiority or Other||LS Mean Difference|-12.18|Standard Error of the Mean|2.851|<|0.0006|2-Sided|90.0|-17.16|-7.21|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622852|NCT02292433|2979298|Superiority or Other||LS Mean Difference|-41.06|Standard Error of the Mean|3.172|<|0.0001|2-Sided|90.0|-46.77|-35.35|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622853|NCT02292433|2979298|Superiority or Other||LS Mean Difference|-19.96|Standard Error of the Mean|4.841|<|0.0032|2-Sided|90.0|-28.93|-10.98|||Mixed Models Analysis|||Analysis was done using a mixed effect model with sequence, period, dose, and baseline as fixed effects and participants within sequence as a random effect.|
1622854|NCT02291861|2979358|Superiority||Mean Difference (Final Values)|-8.4||||0.16|2-Sided|95.0|-20.15|3.34||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo||
1622855|NCT02291861|2979358|Superiority||Mean Difference (Final Values)|-20.2||||0.001|2-Sided|95.0|-32.57|-7.92||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo||
1622856|NCT02291861|2979358|Superiority||Mean Difference (Final Values)|-21.5|||<|0.001|2-Sided|95.0|-33.44|-9.52||5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo||
1622857|NCT02291861|2979359|Superiority||Odds Ratio (OR)|1.13||||0.829|2-Sided|95.0|0.383|3.316||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.||
1622858|NCT02291861|2979359|Superiority||Odds Ratio (OR)|3.96||||0.005|2-Sided|95.0|1.46|10.716||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.||
1622859|NCT02291861|2979359|Superiority||Odds Ratio (OR)|3.8||||0.007|2-Sided|95.0|1.395|10.359||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.||
1622860|NCT02291861|2979360|Superiority||Odds Ratio (OR)|0.69||||0.372|2-Sided|95.0|0.302|1.563||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.||
1622861|NCT02291861|2979360|Superiority||Odds Ratio (OR)|1.82||||0.134|2-Sided|95.0|0.826|3.994||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.||
1622862|NCT02291861|2979360|Superiority||Odds Ratio (OR)|1.51||||0.296|2-Sided|95.0|0.694|3.285||5% level of significance (2-sided)|Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.||
1622863|NCT02291861|2979361|Superiority||LSM difference|1.3||||0.627|2-Sided|95.0|-4.1|6.79||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo||
1622864|NCT02291861|2979361|Superiority||LSM difference|-3.1||||0.281|2-Sided|95.0|-8.86|2.59||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo||
1622962|NCT02289729|2979603|Other||Fisher's z|0.2944||||0.0374|2-Sided|95.0|0.017222|0.516523|||Fisher's z Transformation|||SQLC with NBL C-R|
1622865|NCT02291861|2979361|Superiority||LSM difference|-3.6||||0.207|2-Sided|95.0|-9.18|2.0||5% level of significance (2-sided)|ANCOVA|The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.|SD-809 - placebo||
1622866|NCT02291861|2979362|Superiority||Odds Ratio (OR)|1.15||||0.734|2-Sided|95.0|0.509|2.61|||Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 12 mg/day group and the placebo group, and is the sixth (last) analysis in the fixed-sequence."|
1622867|NCT02291861|2979362|Superiority||Odds Ratio (OR)|2.71||||0.014|2-Sided|95.0|1.211|6.052|||Cochran-Mantel-Haenszel|The statistical test was a CMH test stratified by baseline use of DRAs.|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 24 mg/day group and the placebo group, and is the fourth analysis in the fixed-sequence."|
1622868|NCT02291861|2979362|Superiority||Odds Ratio (OR)|2.11||||0.059|2-Sided|95.0|0.96|4.645|||Cochran-Mantel-Haenszel|The statistical test was a Cochran-Mantel-Haenszel (CMH) test stratified by baseline use of dopamine receptor antagonist (DRAs).|SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 36 mg/day group and the placebo group, and is the second analysis in the fixed-sequence."|
1622869|NCT02291861|2979363|Superiority||LSM difference|-0.7||||0.217|2-Sided|95.0|-1.84|0.42||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 12 mg/day group and the placebo group, and is the fifth analysis in the fixed-sequence."|
1622870|NCT02291861|2979363|Superiority||LSM difference|-1.8||||0.003|2-Sided|95.0|-3.0|-0.63||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~This key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 24 mg/day group and the placebo group, and is the third analysis in the fixed-sequence."|
1622871|NCT02291861|2979363|Superiority||LSM difference|-1.9||||0.001|2-Sided|95.0|-3.09|-0.79||Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.|mixed model for repeated measures||SD-809 - placebo|"A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.~The primary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 36 mg/day group and the placebo group."|
1622872|NCT02291679|2979368|Superiority||Odds Ratio (OR)|2.78||||0.0001|2-Sided|95.0|1.61|4.8||P-value is obtained from the CMH tests controlling for baseline SBM stratum and geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for baseline SBM stratum and geographic region.||
1622873|NCT02291679|2979369|Superiority||LS Mean Difference|-0.178||||0.1028|2-Sided|95.0|-0.391|0.036||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.||
1622874|NCT02291679|2979370|Superiority||LS Mean Difference|-0.319||||0.0063|2-Sided|95.0|-0.548|-0.09||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.||
1622875|NCT02291679|2979371|Superiority||Odds Ratio (OR)|1.49||||0.0342|2-Sided|95.0|1.03|2.17||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.||
1622876|NCT02291679|2979372|Superiority||Odds Ratio (OR)|2.15||||0.0002|2-Sided|95.0|1.42|3.26||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.||
1622877|NCT02291679|2979373|Superiority||Odds Ratio (OR)|2.58|||<|0.0001|2-Sided|95.0|1.58|4.2||P-value is obtained from the CMH tests controlling for geographic region and baseline stratum.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region and baseline stratum.||
1622878|NCT02291679|2979374|Superiority||Odds Ratio (OR)|2.68||||0.0008|2-Sided|95.0|1.47|4.87||P-value is obtained from the CMH tests controlling for geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% CI for the odds ratio are obtained from the CMH tests controlling for geographic region.||
1622963|NCT02289729|2979603|Other||Fisher's z|0.17674||||0.2114|2-Sided|95.0|-0.100105|0.425116|||Fisher's z Transformation|||SQLC with NBL C-D|
1622879|NCT02291679|2979375|Superiority||LS Mean Difference|-0.329|||<|0.0001|2-Sided|95.0|-0.449|-0.21||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.||
1622880|NCT02291679|2979376|Superiority||LS Mean Difference|0.628|||<|0.0001|2-Sided|95.0|0.45|0.806||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.||
1622881|NCT02291679|2979377|Superiority||LS Mean Difference|1.037|||<|0.0001|2-Sided|95.0|0.636|1.438||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a LS mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.||
1622882|NCT02291679|2979378|Superiority||LS Mean Difference|0.841|||<|0.0001|2-Sided|95.0|0.505|1.176||P-value is based on a pairwise comparison versus placebo in an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.|ANCOVA||Linaclotide - Placebo. Estimate and 95% CI are based on a least squares (LS) mean difference from an ANCOVA model with treatment group, baseline SBM stratum, and geographic region as factors and baseline value as covariate.||
1622883|NCT02291679|2979379|Superiority||Odds Ratio (OR)|3.03|||<|0.0001|2-Sided|95.0|1.76|5.2||P-value is obtained from the Cochran-Mantel-Haenszel (CMH) tests controlling for baseline SBM stratum and geographic region.|Cochran-Mantel-Haenszel||Placebo as reference. Odds ratio and 95% confidence interval (CI) for the odds ratio are obtained from the CMH tests controlling for baseline SBM stratum and geographic region.||
1622884|NCT02291549|2979380|Superiority|||||||0.913||||||P-value adjusted for multiplicity using the Holm’s step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.|
1622885|NCT02291549|2979381|Superiority||Mean Difference (Final Values)|-0.46||||0.047|2-Sided|95.0|-0.85|-0.06||P-value adjusted for multiplicity using the Holm’s step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|The adjusted p-value is presentenced.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.|
1622886|NCT02291549|2979382|Superiority||Mean Difference (Final Values)|-0.27||||0.0248|2-Sided|95.0|-0.48|-0.07||P-value adjusted for multiplicity using the Holm’s step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and the alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.|
1622887|NCT02291549|2979383|Superiority||Mean Difference (Final Values)|-7.96||||0.0007|2-Sided|95.0|-12.1|-3.83||P-value adjusted for multiplicity using the Holm’s step-down procedure at a 2-sided significance level of 0.05.|ANCOVA|Adjusted p-value is presented.||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.The null hypothesis was H0: β1 = 0 and the alternative hypothesis was H1: β1 ≠ 0. Although the alternative hypothesis was specified as 2-sided, only a statistically significant, negative estimate of β1 constituted evidence of effectiveness. The 2-sided alpha for this test was 0.05.|
1622888|NCT02291549|2979384|Superiority||Odds Ratio (OR)|2.69||||0.0004|2-Sided|95.0|1.63|4.44||P-value adjusted for multiplicity using the Holm’s step-down procedure at a 2-sided significance level of 0.05.|Cochran-Mantel-Haenszel|Adjusted p-value is presented.||Test: H0: OR = 1 vs. OR ≠ 1 by Cochrane-Mantel-Haenszel test|
1622889|NCT02291549|2979385|Superiority||Mean Difference (Final Values)|-0.35||||0.0073|2-Sided|95.0|-0.6|-0.09||The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparisons.|ANCOVA|ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.||The between treatment group difference was estimated using the ANCOVA model with site and treatment group as fixed effects. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the bilateral polyp grade compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.|
1622890|NCT02291549|2979386|Superiority||Mean Difference (Final Values)|-0.23||||0.0074|2-Sided|95.0|-0.39|-0.06||The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparison.|ANCOVA|Where appropriate, confidence intervals of the difference were constructed using the estimate of the least-squares means||ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the Nasal Obstruction/Congestion score compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.|
1622891|NCT02291510|2979387|Superiority or Other||% Ratio of LS Means|79.3||||0.0004|2-Sided|90.0|71.65|87.86|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.|
1622892|NCT02291510|2979387|Superiority or Other||% Ratio of LS Means|66.8|||<|0.001|2-Sided|90.0|60.34|74.0|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.|
1623032|NCT02289729|2979644|Superiority|||||||0.0109|||||||t-test||||
1622893|NCT02291510|2979387|Superiority or Other||% Ratio of LS Means|45.3|||<|0.001|2-Sided|90.0|40.88|50.13|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.|
1622894|NCT02291510|2979387|Superiority or Other||% Ratio of LS Means|53.0|||<|0.001|2-Sided|90.0|47.88|58.71|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.|
1622895|NCT02291510|2979387|Superiority or Other||% Ratio of LS Means|35.9|||<|0.001|2-Sided|90.0|32.43|39.77|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.|
1622896|NCT02291510|2979388|Superiority or Other||% Ratio of LS Means|110.1||||0.0832|2-Sided|90.0|100.5|120.68|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.|
1622897|NCT02291510|2979388|Superiority or Other||% Ratio of LS Means|47.5|||<|0.001|2-Sided|90.0|43.38|52.09|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.|
1622898|NCT02291510|2979388|Superiority or Other||% Ratio of LS Means|32.1|||<|0.001|2-Sided|90.0|29.3|35.18|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met IR BID is the denominator for the % ratio of LS means and the comparator for the p-values.|
1622899|NCT02291510|2979388|Superiority or Other||% Ratio of LS Means|52.3|||<|0.001|2-Sided|90.0|47.77|57.36|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of LS means and the comparator for the p-values.|
1622900|NCT02291510|2979388|Superiority or Other||% Ratio of LS Means|35.4|||<|0.001|2-Sided|90.0|32.27|38.74|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||2000 mg Met XR QD is the denominator for the % ratio of least squares (LS) means and the comparator for the p-values.|
1622901|NCT02291237|2979395|Superiority||LS Mean Difference(Eleclazine - Placebo)|0.0||||0.993|2-Sided|95.0|-0.96|0.97|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in treadmill exercise time from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).|
1622902|NCT02291237|2979396|Superiority||LS Mean Difference(Eleclazine - Placebo)|-0.04||||0.944|2-Sided|95.0|-1.18|1.1|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in treadmill exercise time from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).|
1622903|NCT02291237|2979397|Superiority||LS Mean Difference(Eleclazine − Placebo)|0.1||||0.964|2-Sided|95.0|-4.36|4.56|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in MLHFQ from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).|
1622904|NCT02291237|2979398|Superiority||LS Mean Difference(Eleclazine - Placebo)|1.54||||0.513|2-Sided|95.0|-3.11|6.19|||ANCOVA|P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline score as the covariate.||The analysis evaluated the change in MLHFQ from baseline to Week 24 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline treadmill exercise time, sex, and age (continuous).|
1622905|NCT02291237|2979399|Superiority||LS Mean Difference(Eleclazine − Placebo)|-0.42||||0.517|2-Sided|95.0|-1.68|0.85||P-value and LS Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.|ANCOVA|||The analysis evaluated the change in Peak VO2 from baseline to Week 12 for the eleclazine group compared with that of the placebo group using ANCOVA including terms for baseline Peak VO2, sex, and age (continuous).|
1622906|NCT02291237|2979400|Superiority||LS Mean Difference(Eleclazine - Placebo)|-0.55||||0.416|2-Sided|95.0|-1.87|0.78|||ANCOVA|P-value and Least Squares (LS) Means are from model with terms for sex, age (continuous), and treatment group and baseline peak VO2 as the covariate.||The analysis evaluated the change in Peak VO2 from baseline to Week 24 for the eleclazine group compared with that of the placebo group using analysis of covariance (ANCOVA) including terms for baseline Peak VO2, sex, and age (continuous).|
1622907|NCT02291029|2979401|Superiority||Mean Difference (Net)|-9.83||||0.074|2-Sided|95.0|-20.66|1.01|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622908|NCT02291029|2979401|Superiority||Mean Difference (Net)|1.34||||0.807|2-Sided|95.0|-10.48|13.15|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622909|NCT02291029|2979402|Superiority||Mean Difference (Net)|3.83||||0.175|2-Sided|95.0|-1.81|9.48|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622910|NCT02291029|2979402|Superiority||Mean Difference (Net)|-0.07||||0.986|2-Sided|95.0|-8.49|8.35|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622911|NCT02291029|2979403|Superiority||Mean Difference (Net)|3.83||||0.175|2-Sided|95.0|-1.81|9.48|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622912|NCT02291029|2979403|Superiority||Mean Difference (Net)|-5.5||||0.172|2-Sided|95.0|-13.91|2.91|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622913|NCT02291029|2979404|Superiority||Mean Difference (Net)|-8.14||||0.376|2-Sided|95.0|-26.67|10.39|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622914|NCT02291029|2979404|Superiority||Mean Difference (Net)|-9.45||||0.456|2-Sided|95.0|-36.2|17.3|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622915|NCT02291029|2979405|Superiority||Mean Difference (Net)|-12.16||||0.017|2-Sided|95.0|-21.94|-2.38|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622916|NCT02291029|2979405|Superiority||Mean Difference (Net)|-15.26||||0.161|2-Sided|95.0|-37.9|7.38|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622917|NCT02291029|2979406|Superiority||Mean Difference (Net)|-0.37||||0.663|2-Sided|95.0|-2.08|1.35|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622918|NCT02291029|2979406|Superiority||Mean Difference (Net)|-0.95||||0.188|2-Sided|95.0|-2.41|0.5|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622919|NCT02291029|2979406|Superiority||Mean Difference (Net)|-1.09||||0.205|2-Sided|95.0|-2.97|0.8|||Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622920|NCT02291029|2979407|Superiority||Mean Difference (Net)|2.34||||0.344|2-Sided|95.0|-2.78|7.45||two-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate.|||
1622921|NCT02291029|2979407|Superiority||Mean Difference (Net)|-5.21||||0.009|2-Sided|95.0|-9.46|-0.96||One-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate.|||
1622922|NCT02291029|2979407|Superiority||Mean Difference (Net)|-0.41||||0.397|2-Sided|95.0|-3.7|2.89||One-sided p-value|Repeated measures model|with time (as nominal study week), the interaction between time and treatment (all as fixed effects) and with baseline as a covariate|||
1622923|NCT02290925|2979420|Other|general linear model (GLM) with repeated measures|Mean Difference (Net)|0.25|||||2-Sided||||||||Box's M tests was used. Mauchly's test was used to verify that the error covariance matrix of the orthonormalized-transformed dependent variables is proportional to an identity matrix.||We used intention to treat analysis. Since the missing data were more than 5%, we examined the dataset to determine whether it shows “missing completely at random” (MCAR) “not missing at random (NMAR)” or “data missing at random” (MAR). A sensitivity analysis was done to determine whether multiple imputations are required. It included complete case analysis, best-worst case and worst best case scenario with group mean±1SD.
1622924|NCT02290873|2979423|Superiority||Hazard Ratio (HR)|6.133|||<|0.0001|2-Sided|95.0|4.416|8.517|||Log Rank||||
1622925|NCT02290873|2979424|Superiority||Median Difference (Net)|0.8961|||<|0.0001|2-Sided|95.0|0.8505|0.9416||P-value calculated from a Cochran-Mantel-Haenszel test accounting for fentanyl strata.|Cochran-Mantel-Haenszel||||
1622926|NCT02290431|2979488|Superiority||||||<|0.0001|||||||single-sample binomial test||||
1622927|NCT02290184|2979527|Superiority|A multi-level regression was used to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected CI.|cross-level interaction|-2.7|||||2-Sided|95.0|-4.5|-0.91|||||"Multilevel regression was used. The primary test of between -group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: Intervention group will have a significantly greater reduction in waist-circumference (cm) compared to the Active Control from baseline to 3-months|
1622928|NCT02290184|2979528|Superiority|Multi-level regression was used to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected CI.|cross-level interaction|-2.6|||||2-Sided|0.05|-3.9|-1.4|||||"Multilevel regression was used. The primary test of between group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: Intervention group will have a significantly greater reduction in % weight change compared to the active control from baseline to 3-months|
1622929|NCT02290184|2979529|Superiority or Other|A multi-level regression was employed to test differences between the 2 arm's change trajectories of their estimated simple slopes. Bootstrapped full information maximum likelihood models were estimated to obtain nonparametric, bias-corrected confidence interval (CI).|cross-level interaction|-2.0|||||2-Sided|0.05|-3.0|-1.1|||||"Multilevel regression analysis was used. The primary test of between-group change effect is also called the cross-level interaction between time and group. Simple slopes were also tested to determine if the change was significant within each group."|Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the active control from baseline to 3-months.|
1622930|NCT02289963|2979549|Superiority||LS Mean Difference|-4.515||||0.311|2-Sided|95.0|-13.25|4.219||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622931|NCT02289963|2979550|Superiority||LS Mean Difference|7.5||||0.0029|2-Sided|95.0|2.6|12.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622932|NCT02289963|2979551|Superiority||Adjusted Mean Difference|-33.611|||<|0.0001|2-Sided|95.0|-41.883|-25.338||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622933|NCT02289963|2979552|Superiority||Odds Ratio (OR)|70.0|||<|0.0001|2-Sided|95.0|23.3|210.8||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622934|NCT02289963|2979553|Superiority||Odds Ratio (OR)|46.9|||<|0.0001|2-Sided|95.0|18.4|119.4||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622935|NCT02289963|2979554|Superiority||LS Mean Difference|-35.8|||<|0.0001|2-Sided|95.0|-39.7|-31.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant.|
1622936|NCT02289963|2979555|Superiority||LS Mean Difference|-51.2|||<|0.0001|2-Sided|95.0|-56.4|-46.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622937|NCT02289963|2979556|Superiority||LS Mean Difference|-46.1|||<|0.0001|2-Sided|95.0|-51.2|-41.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622938|NCT02289963|2979557|Superiority||LS Mean Difference|-35.2|||<|0.0001|2-Sided|95.0|-40.3|-30.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622939|NCT02289963|2979558|Superiority||LS Mean Difference|-54.2|||<|0.0001|2-Sided|95.0|-60.6|-47.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622940|NCT02289963|2979559|Superiority||LS Mean Difference|-51.5|||<|0.0001|2-Sided|95.0|-58.4|-44.6||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622941|NCT02289963|2979560|Superiority||LS Mean Difference|-49.2|||<|0.0001|2-Sided|95.0|-55.3|-43.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622942|NCT02289963|2979561|Superiority||LS Mean Difference|-46.3|||<|0.0001|2-Sided|95.0|-53.0|-39.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622943|NCT02289963|2979562|Superiority||LS Mean Difference|-63.1|||<|0.0001|2-Sided|95.0|-69.2|-57.0||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622944|NCT02289963|2979563|Superiority||LS Mean Difference|-62.5|||<|0.0001|2-Sided|95.0|-68.8|-56.3||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1622945|NCT02289963|2979564|Superiority||LS Mean Difference|-66.2|||<|0.0001|2-Sided|95.0|-73.9|-58.4||Threshold for significance was at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/Up to 150 mg Q2W vs. Placebo Q2W|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|
1622946|NCT02289963|2979565|Superiority||Least Square (LS) Mean Difference|-63.4|||<|0.0001|2-Sided|95.0|-71.6|-55.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 75 mg Q2W/ Up to 150 mg Q2W vs. Placebo Q2W|Alirocumab group was compared to placebo group using an appropriate contrast statement.|
1622947|NCT02289898|2979566|Superiority||Hazard Ratio (HR)|0.93|||=|0|2-Sided|95.0|0.63|1.375|||Wilcoxon (Mann-Whitney)|||Efficacy (investigator-assessed Kaplan-Meier estimates of progression-free survival) of placebo/placebo arm to the pooled demcizumab arm (i.e., placebo/placebo arm to demcizumab/placebo and demcizumab/demcizumab arms) in subjects with first-line metastatic pancreatic ductal adenocarcinoma.|
1622948|NCT02289729|2979602|Other||Fisher's z|0.11688||||0.4382|2-Sided|95.0|-0.176724|0.390468|||Fisher's z Transformation|||SQLC with Global NMSS|
1622949|NCT02289729|2979602|Other||Fisher's z|-0.13015||||0.3826|2-Sided|95.0|-0.398887|0.16062|||Fisher's z Transformation|||SQLC with UPDRS-IV|
1622950|NCT02289729|2979602|Other||Fisher's z|-0.23658||||0.1125|2-Sided|95.0|-0.484427|0.055538|||Fisher's z Transformation|||SQLC with UPDRS-III|
1622951|NCT02289729|2979602|Other||Fisher's z|-0.33661||||0.0239|2-Sided|95.0|-0.557217|-0.044411|||Fisher's z Transformation|||SQLC with Global PDQ-39|
1622952|NCT02289729|2979602|Other||Fisher's z|-0.10293||||0.4899|2-Sided|95.0|-0.375749|0.187021|||Fisher's z Transformation|||SQLC with NBL C-R|
1622953|NCT02289729|2979602|Other||Fisher's z|0.00326||||0.9826|2-Sided|95.0|-0.281136|0.287128|||Fisher's z Transformation|||SQLC with NBL C-D|
1622954|NCT02289729|2979602|Other||Fisher's z|-0.1106||||0.4581|2-Sided|95.0|-0.382323|0.179601|||Fisher's z transformation|||SQLC with NBL A-S|
1622955|NCT02289729|2979602|Other||Fisher's z|-0.06987||||0.8251|2-Sided|95.0|-0.597767|0.500464|||Fisher's z Transformation|||SQLC with Goldberg Depression|
1622956|NCT02289729|2979602|Other||Fisher's z|0.17924||||0.5347|2-Sided|95.0|-0.368382|0.632178|||Fisher's z Transformation|||SQLC with Goldberg Anxiety|
1622957|NCT02289729|2979602|Other||Fisher's z|-0.7468|||<|0.0001|2-Sided|95.0|-0.777482|-0.425693|||Fisher's z Transformation|||SQLC with ZBI|
1623033|NCT02289729|2979645|Superiority|||||||0.0003|||||||t-test||||
1622965|NCT02289729|2979603|Other||Fisher's z|-0.48143||||0.0239|2-Sided|95.0|-0.715956|-0.063481|||Fisher's z Transformation|||SQLC with Goldberg Depression|
1622966|NCT02289729|2979603|Other||Fisher's z|-0.16332||||0.4142|2-Sided|95.0|-0.504489|0.224771|||Fisher's z Transformation|||SQLC with Goldberg Anxiety|
1622967|NCT02289729|2979603|Other||Fisher's z|-0.57271|||<|0.0001|2-Sided|95.0|-0.689585|-0.289724|||Fisher's z Transformation|||SQLC with ZBI|
1622968|NCT02289729|2979604|Other||Fisher's z|0.10898||||0.7058|2-Sided|95.0|-0.427482|0.588111|||Fisher's z Transformation|||PDQ-39 with Goldberg-Depression|
1622969|NCT02289729|2979604|Other||Fisher's z|0.64565|||<|0.0001|2-Sided|95.0|0.339454|0.734221|||Fisher's z Transformation|||PDQ-39 with Goldberg-Anxiety|
1622970|NCT02289729|2979604|Other||Fisher's z|-0.33661|||<|0.0239|2-Sided|95.0|-0.557217|-0.044411|||Fisher's z Transformation|||PDQ-39 with ZBI|
1622971|NCT02289729|2979604|Other||Fisher's z|0.41143|||<|0.0036|2-Sided|95.0|0.133445|0.597087|||Fisher's z Transformation|||PDQ-39 with NBL C-R|
1622972|NCT02289729|2979604|Other||Fisher's z|0.60613|||<|0.0001|2-Sided|95.0|0.31758|0.708076|||Fisher's z Transformation|||PDQ-39 with NBL C-D|
1622973|NCT02289729|2979604|Other||Fisher's z|0.60612|||<|0.0001|2-Sided|95.0|0.317572|0.708072|||Fisher's z Transformation|||PDQ-39 with NBL A-S|
1622974|NCT02289729|2979604|Other||Fisher's z|0.67113|||<|0.0001|2-Sided|95.0|0.374757|0.739016|||Fisher's z Transformation|||PDQ-39 with PFS|
1622975|NCT02289729|2979604|Other||Fisher's z|0.24114|||<|0.0882|2-Sided|95.0|-0.036024|0.476404|||Fisher's z Transformation|||PDQ-39 with AS|
1622976|NCT02289729|2979604|Other||Fisher's z|0.63758|||<|0.0001|2-Sided|95.0|0.345567|0.72341|||Fisher's z Transformation|||PDQ-39 with BDI-II|
1622977|NCT02289729|2979604|Other||Fisher's z|0.70289|||<|0.0001|2-Sided|95.0|0.40173|0.753097|||Fisher's z Transformation|||PDQ-39 with BAI|
1622978|NCT02289729|2979604|Other||Fisher's z|0.38627|||<|0.0069|2-Sided|95.0|0.105875|0.582517|||Fisher's z Transformation|||PDQ-39 with NMSS|
1622979|NCT02289729|2979604|Other||Fisher's z|0.36796|||<|0.0093|2-Sided|95.0|0.090528|0.568388|||Fisher's z Transformation|||PDQ-39 with UPDRS-IV|
1622980|NCT02289729|2979604|Other||Fisher's z|0.31946|||<|0.0239|2-Sided|95.0|0.042257|0.534657|||Fisher's z Transformation|||PDQ-39 with UPDRS-III|
1622981|NCT02289729|2979605|Other||Fisher's z|0.57423||||0.0041|2-Sided|95.0|0.180247|0.74704|||Fisher's z Transformation|||PDQ-39 with Goldberg-Depression|
1622982|NCT02289729|2979605|Other||Fisher's z|0.21643||||0.1222|2-Sided|95.0|-0.057959|0.454911|||Fisher's z Transformation|||PDQ-39 with Goldberg-Anxiety|
1622983|NCT02289729|2979605|Other||Fisher's z|-0.36687||||0.0088|2-Sided|95.0|-0.565795|-0.092154|||Fisher's z Transformation|||PDQ-39 with ZBI|
1622984|NCT02289729|2979605|Other||Fisher's z|0.00011||||0.9993|2-Sided|95.0|-0.260462|0.260673|||Fisher's z Transformation|||PDQ-39 with NBL C-R|
1622985|NCT02289729|2979605|Other||Fisher's z|0.35742||||0.006|2-Sided|95.0|0.106797|0.565335|||Fisher's z Transformation|||PDQ-39 with NBL C-D|
1622986|NCT02289729|2979605|Other||Fisher's z|0.22455||||0.0989|2-Sided|95.0|-0.042139|0.455224|||Fisher's z Transformation|||PDQ-39 with NBL A-S|
1622987|NCT02289729|2979605|Other||Fisher's z|0.34688||||0.0108|2-Sided|95.0|0.079996|0.546657|||Fisher's z Transformation|||PDQ-39 with PFS|
1622988|NCT02289729|2979605|Other||Fisher's z|0.08869||||0.5146|2-Sided|95.0|-0.176169|0.341163|||Fisher's z Transformation|||PDQ-39 with AS|
1622989|NCT02289729|2979605|Other||Fisher's z|0.49952||||0.0002|2-Sided|95.0|0.230995|0.643312|||Fisher's z Transformation|||PDQ-39 with BDI-II|
1622990|NCT02289729|2979605|Other||Fisher's z|0.29062||||0.0311|2-Sided|95.0|0.026334|0.504186|||Fisher's z Transformation|||PDQ-39 with BAI|
1622991|NCT02289729|2979605|Other||Fisher's z|0.21311||||0.114|2-Sided|95.0|-0.051127|0.444152|||Fisher's z Transformation|||PDQ-39 with NMSS|
1622992|NCT02289729|2979605|Other||Fisher's z|0.07359||||0.5852|2-Sided|95.0|-0.188409|0.32558|||Fisher's z Transformation|||PDQ-39 with UPDRS-IV|
1622993|NCT02289729|2979605|Other||Fisher's z|0.27846||||0.0389|2-Sided|95.0|0.014175|0.495059|||Fisher's z Transformation|||PDQ-39 with UPDRS-III|
1622994|NCT02289729|2979606|Superiority|||||||0.6741|||||||t-test||||
1622995|NCT02289729|2979607|Superiority|||||||0.6481|||||||t-test||||
1622996|NCT02289729|2979608|Superiority|||||||1|||||||t-test||||
1622997|NCT02289729|2979609|Superiority|||||||0.5922|||||||t-test||||
1622998|NCT02289729|2979610|Superiority|||||||0.0234|||||||signed-rank test||||
1622999|NCT02289729|2979611|Superiority|||||||0.7937|||||||t-test||||
1623000|NCT02289729|2979612|Superiority|||||||0.1945|||||||signed-rank test||||
1623001|NCT02289729|2979613|Superiority|||||||0.8321|||||||t-test||||
1623002|NCT02289729|2979614|Superiority|||||||0.4048|||||||t-test||||
1623003|NCT02289729|2979615|Superiority|||||||0.8145|||||||t-test||||
1623004|NCT02289729|2979616|Superiority|||||||0.1533|||||||t-test||||
1623005|NCT02289729|2979617|Superiority|||||||0.3126|||||||t-test||||
1623006|NCT02289729|2979618|Superiority|||||||0.0687|||||||t-test||||
1623007|NCT02289729|2979619|Superiority|||||||0.2428|||||||signed-rank test||||
1623008|NCT02289729|2979620|Superiority||||||<|0.0001|||||||signed-rank test||||
1623009|NCT02289729|2979621|Superiority|||||||0.0001|||||||t-test||||
1623010|NCT02289729|2979622|Superiority||||||<|0.0001|||||||t-test||||
1623011|NCT02289729|2979623|Superiority||||||<|0.0001|||||||signed-rank test||||
1623012|NCT02289729|2979624|Superiority||||||<|0.0001|||||||t-test||||
1623013|NCT02289729|2979625|Superiority||||||<|0.0001|||||||t-test||||
1623014|NCT02289729|2979626|Superiority|||||||0.0002|||||||t-test||||
1623015|NCT02289729|2979627|Superiority||||||<|0.5877|||||||t-test||||
1623016|NCT02289729|2979628|Superiority|||||||0.0003|||||||t-test||||
1623017|NCT02289729|2979629|Superiority|||||||0.0047|||||||t-test||||
1623018|NCT02289729|2979630|Superiority|||||||0.2777|||||||t-test||||
1623019|NCT02289729|2979631|Superiority|||||||0.0279|||||||t-test||||
1623020|NCT02289729|2979632|Superiority|||||||0.0297|||||||t-test||||
1623021|NCT02289729|2979633|Superiority|||||||0.0002|||||||t-test||||
1623022|NCT02289729|2979634|Superiority|||||||0.001|||||||signed-rank test||||
1623023|NCT02289729|2979635|Superiority|||||||0.0006|||||||t-test||||
1623041|NCT02289690|2979654|Superiority||Odds Ratio (OR)|0.8||||0.604|2-Sided|80.0|0.5|1.3|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by LDH level.|Odds ratio was from a Cochran-Mantel-Haenszel test stratified by LDH level. An odds ratio of > 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~OS (Arm A vs Arm C)~PFS (Arms B vs Arm C)~OS (Arm B vs Arm C)~ORR (Arm A vs Arm C)~ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."|
1623042|NCT02289690|2979654|Superiority||Odds Ratio (OR)|1.9||||0.115|2-Sided|80.0|1.1|3.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by LDH level.|Odds ratio was from a Cochran-Mantel-Haenszel test stratified by LDH level. An odds ratio of > 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~OS (Arm A vs Arm C)~PFS (Arms B vs Arm C)~OS (Arm B vs Arm C)~ORR (Arm A vs Arm C)~ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."|
1623043|NCT02289690|2979655|Superiority||Hazard Ratio (HR)|1.46||||0.083|2-Sided|80.0|1.104|1.931|||Log Rank|Two-sided log rank test stratified by LDH level.|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of < 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~OS (Arm A vs Arm C)~PFS (Arms B vs Arm C)~OS (Arm B vs Arm C)~ORR (Arm A vs Arm C)~ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."|
1623044|NCT02289690|2979655|Superiority||Hazard Ratio (HR)|1.432||||0.088|2-Sided|80.0|1.092|1.879|||Log Rank|Two-sided log rank test stratified by LDH level.|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of < 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~OS (Arm A vs Arm C)~PFS (Arms B vs Arm C)~OS (Arm B vs Arm C)~ORR (Arm A vs Arm C)~ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."|
1623045|NCT02289690|2979656|Superiority||Hazard Ratio (HR)|0.979||||0.924|2-Sided|80.0|0.744|1.288|||Log Rank|Two-sided log-rank test stratified by lactate dehydrogenase (LDH) level|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio of < 1 favors veliparib in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm B).|"If the primary analysis of PFS (Arm A vs Arm C) was statistically significant a fixed sequence testing procedure was to be performed with a 2-sided significance level of 0.2 for the following key secondary endpoints:~OS (Arm A vs Arm C)~PFS (Arms B vs Arm C)~OS (Arm B vs Arm C)~ORR (Arm A vs Arm C)~ORR (Arm B vs Arm C)~If significance versus Arm C was not demonstrated, all endpoints later in the testing hierarchy were to be considered exploratory."|
1623046|NCT02289690|2979656|Superiority||Hazard Ratio (HR)|0.665||||0.059|2-Sided|80.0|0.503|0.88|||Log Rank|Two-sided log-rank test stratified by lactate dehydrogenase (LDH) level|Hazard ratio estimate was obtained from a Cox proportional hazards model stratified by LDH level. A hazard ratio < 1 favors veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A).|"The primary efficacy analysis in the Phase 2 portion of the study was the comparison of PFS among participants who received veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy (Arm A) vs. placebo in combination with carboplatin and etoposide followed by placebo maintenance monotherapy (Arm C).~Statistical significance was determined by a two-sided p-value ≤ 0.2"|
1623047|NCT02289690|2979672|Other||RP2D for veliparib in mg BID for 14 days|240.0|||||2-Sided||||||||The RP2D for veliparib was determined to be 240 mg BID for 14 days with carboplatin (AUC 5 mg/mL*min) on Day 1 and etoposide (100 mg/m²) on Days 1 to 3 during 21-day cycles for 4 cycles.|A primary objective of Phase 1 was to establish the recommended phase 2 dose (RP2D) for veliparib combined with carboplatin and etoposide. The RP2D was determined by the rate of DLTs and overall tolerability of veliparib plus carboplatin and etoposide.|
1623048|NCT02289469|2979673|Other||||||<|0.01|||||||Other|||Descriptive statistics (counts, frequencies) were used to summarize responses.|
1623049|NCT02289469|2979674|Superiority||Mean Difference (Final Values)|23.8|||<|0.0001|2-Sided|95.0|16.0|31.6|||Chi-squared|||A chi-square test was used to test for differences in proportions between intervention and control groups.|
1623050|NCT02289417|2979692|Superiority||Stratified Difference|32.5||||0.0004|2-Sided|95.0|14.9|47.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623051|NCT02289417|2979692|Superiority||Stratified Difference|16.6||||0.0758|2-Sided|95.0|-1.5|33.3|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623052|NCT02289417|2979693|Superiority||Stratified Difference|18.1||||0.0534|2-Sided|95.0|-0.3|34.9|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623173|NCT02285010|2980160|Non-Inferiority|Alpha 0.05, beta 80%||||||0.54|||||||Chi-squared|||For Dizziness|
1623174|NCT02285010|2980160|Non-Inferiority|alpha 0.05, beta 80%||||||0.46|||||||Chi-squared|||For Vomiting|
1623053|NCT02289417|2979693|Superiority||Stratified Difference|14.6||||0.1167|2-Sided|95.0|-3.3|31.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623054|NCT02289417|2979694|Superiority||Stratified Difference|19.8||||0.037|2-Sided|95.0|1.5|36.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623055|NCT02289417|2979694|Superiority||Stratified Difference|16.7||||0.0755|2-Sided|95.0|-1.4|33.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623056|NCT02289417|2979695|Superiority||Stratified Difference|6.0||||0.4476||95.0|-9.8|21.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623057|NCT02289417|2979695|Superiority||Stratified Difference|24.8||||0.0046|2-Sided|95.0|7.5|40.1|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623058|NCT02289417|2979696|Superiority||Stratified Difference|13.5||||0.0788|2-Sided|95.0|-1.6|27.7||Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Cochran-Mantel-Haenszel||Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623059|NCT02289417|2979696|Superiority||Stratified Difference|11.5||||0.1388|2-Sided|95.0|-4.1|26.1|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623060|NCT02289417|2979697|Superiority||Stratified Difference|3.7||||0.6878|2-Sided|95.0|-14.4|21.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623061|NCT02289417|2979697|Superiority||Stratified Difference|32.0||||0.0005|2-Sided|95.0|13.8|47.4|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623062|NCT02289417|2979698|Superiority||Stratified Difference|3.1||||0.4628|2-Sided|95.0|-7.5|14.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623063|NCT02289417|2979698|Superiority||Stratified Difference|5.2||||0.2472|2-Sided|95.0|-5.7|16.7|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623064|NCT02289417|2979699|Superiority||Stratified Difference|19.4||||0.0401|2-Sided|95.0|1.1|36.0|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623065|NCT02289417|2979699|Superiority||Stratified Difference|14.6||||0.1224|2-Sided|95.0|-3.6|31.5|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623066|NCT02289417|2979700|Superiority||Stratified Difference|7.7||||0.2689|2-Sided|95.0|-6.9|22.0|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of PO corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method||
1623067|NCT02289417|2979700|Superiority||Stratified Difference|19.2||||0.0142|2-Sided|95.0|3.4|33.6|||Cochran-Mantel-Haenszel|Stratification was based on baseline use of oral (PO) corticosteroids and previously used immunosuppressants (yes/no).|Stratified difference in percentages is the weighted average of the treatment differences across the strata with the CMH weights, with 2-sided 95% CI based on the stratified Newcombe method.||
1623068|NCT02289352|2979701|Superiority|||||||0.0045|||||||t-test, 2 sided||||
1623069|NCT02289352|2979701|Superiority||||||<|0.0001|||||||t-test, 2 sided||||
1623070|NCT02289352|2979701|Equivalence|"The secondary efficacy variable is the proportion of patients with a clinical response of treatment success on Day 1.~If the 90% confidence interval for the absolute difference between the proportion of patients considered a treatment success (at least a 2-grade improvement on both the CEA and PSA over 6 hours+/-10 minutes) in the Test and Reference groups is contained within the range [-20%, 20%], then bioequivalence of the Test to Reference product is considered to have been demonstrated."|Mean Difference (Net)|6.94|||<||2-Sided|90.0|-1.54|15.41|||||||
1623071|NCT02289352|2979702|Superiority||||||<|0.0001|||||||t-test, 2 sided||||
1623073|NCT02289352|2979702|Equivalence|If the 90% confidence interval for the absolute difference between the proportion of patients considered a treatment success (at least a 2-grade improvement on both CEA and PSA over 6 hours+/-10 minutes) in the Test and Reference groups is contained within the range [-20%, +20%], then bioequivalence of the Test product to the Reference product is considered to have been demonstrated.|Mean Difference (Net)|-0.58|||<||2-Sided|90.0|-6.49|5.33|||||||
1623074|NCT02289157|2979706|Other|Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity||||||0.74|||||||Cochran-Mantel-Haenszel||||
1623075|NCT02289157|2979707|Other|Cochran-Mantel-Haenzel measure used to estimate interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.||||||0.22|||||||Cochran-Mantel-Haenszel||||
1623076|NCT02289157|2979708|Other|Cochran-Mantel-Haenzel measure used to estimate interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing in wound morbidity||||||0.92|||||||Cochran-Mantel-Haenszel||||
1623077|NCT02289157|2979709|Other|Cochran-Mantel-Haenzel test for interactions between labor vs no labor stratified by icNPT vs Standard dressing||||||0.49|||||||Cochran-Mantel-Haenszel||||
1623078|NCT02289157|2979710|Other|Cochran-Mantel-Haenzel test for interactions between different risk factors: ruptured vs unruptured membranes and icNPT vs Standard dressing||||||0.55|||||||Cochran-Mantel-Haenszel||||
1623079|NCT02289157|2979711|Other|Cochran-Mantel-Haenzel test for interactions between different risk factors: pfannenstiel vs midline abdominal incision and icNPT vs Standard dressing||||||0.27|||||||Cochran-Mantel-Haenszel||||
1623080|NCT02289157|2979712|Other|Cochran-Mantel-Haenzel test for interactions between different risk factors: scheduled vs unscheduled cesarean section and icNPT vs Standard dressing||||||0.68||||||Ho: There is no difference between patients with wound morbidity that is significantly affected by the use of icNPT and whether or not the cesarean is scheduled or unscheduled.|Cochran-Mantel-Haenszel||||
1623081|NCT02289157|2979713|Other|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in the number of patients with Incision and Drainage and/or Extirpation between the study (icNPT) and comparison groups.|
1623082|NCT02289157|2979713|Other|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in the use of post operative antimicrobials between the the study (icNPT) and comparison groups.|
1623083|NCT02289157|2979713|Other|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference between number of readmissions between the study (icNPT) and comparison groups.|
1623084|NCT02289157|2979714|Other|||||||0.48||||||Ho: There is no difference between the number of visits made to the clinic for wound morbidity per patient between the study (icNPT) and comparison groups.|Chi-squared||||
1623085|NCT02289157|2979715|Other|||||||0.38|||||||Chi-squared|||Ho: There is no difference between the number of ER visits made per person between the study (icNPT) and comparison groups.|
1623086|NCT02289157|2979716|Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Ho: There is no difference in length of stay after readmission for wound morbidity between the study (icNPT) and comparison groups.|
1623087|NCT02289157|2979717|Other|||||||0.54||||||Ho: There is no difference between initial length of stay between the study (icNPT) and comparison groups.|Wilcoxon (Mann-Whitney)||||
1623088|NCT02289157|2979718|Other|||||||0.31|||||||Chi-squared|Pearson Chi-squared, df (3)||Ho: There is no difference between the types wound morbidity in the study (icNPT) and comparison groups.|
1623089|NCT02289157|2979719|Other||Risk Ratio (RR)|0.9||||0.54|2-Sided|95.0|0.5|1.4|||Regression, Logistic|Ho: There is no difference between number of patients with wound complications between the study (icNPT) and comparison groups.|||
1623090|NCT02288559|2979749|Superiority||Difference in Adjusted Means|-0.21||||0.3361|2-Sided|80.0|-0.491|0.071|||MMRM|MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.|||
1623091|NCT02288559|2979749|Superiority||Difference in Adjusted Means|0.435||||0.0428|2-Sided|80.0|0.162|0.707|||Mixed-Effect Model Repeated Measures|MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.|||
1623092|NCT02288364|2979756|Superiority or Other|||||||0.29|||||||Chi-squared||||
1623093|NCT02288364|2979757|Superiority or Other|||||||0.08|||||||Chi-squared||||
1623094|NCT02288364|2979758|Superiority or Other|||||||0.3|||||||Chi-squared||||
1623095|NCT02288325|2979760|Superiority||Hazard Ratio (HR)|0.56||||0.0212|2-Sided|95.0|0.33|0.92|||Log Rank||||
1623096|NCT02288273|2979771|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1623097|NCT02288182|2979775|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Student's t-test comparing the group means was planned and performed (successfully). However, due to some outliers, the central tendencies have been reported as medians (instead of arithmetic means). Therefore an additional non-parameteric test (Mann-Whitney U-test) was performed.|
1623098|NCT02287883|2979809|Other|Clustered two-sample t-test||||||0.05|||||||t-test, 2 sided||||
1623099|NCT02287883|2979810|Other|Clustered two-sample t-test||||||0.48|||||||t-test, 2 sided||||
1623100|NCT02287883|2979811|Other|Clustered two-sample t-test||||||0.8|||||||t-test, 2 sided||||
1623101|NCT02287467|2979882|Superiority||ratio of geometric means|0.94||||0.78|2-Sided|95.0|0.58|1.5|||Mixed Models Analysis|log-transformed titers adjusted for baseline titer|ratio of geometric mean for hIVIG vs placebo. A ratio > 1.0 indicates higher titers at day 7 for the hIVIG group.||
1623102|NCT02287467|2979883|Superiority||ratio of geometric means|1.31||||0.13|2-Sided|95.0|0.93|1.8|||Mixed Models Analysis|longitudinal analysis of log-transformed titers adjust for baseline titer.|Ratio of geometric means of hIVIG vs placebo. A ratio >1.0 indicates higher titers in the hIVIG group on day 7.||
1623103|NCT02287467|2979884|Superiority||ratio of geometric means|1.5||||0.18|2-Sided|95.0|0.84|2.7|||Mixed Models Analysis|longitudinal regression with adjustment for baseline titer|Ratio of hIVIG group to placebo group. A ratio > 1.0 indicates higher titers for the hIVIG group.|HAI measurements were log-transformed to compute treatment differences and the model was adjusted for baseline titer.|
1623175|NCT02285010|2980160|Non-Inferiority|Alpha 0.05, beta 80%||||||0.66|||||||Chi-squared|||For Nausea|
1623104|NCT02287467|2979885|Superiority||Odds Ratio (OR)|3.19||||0.02|2-Sided|95.0|1.21|8.42|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|Odds ratio (hIVIG vs placebo) for a better outcome. An odds ratio > 1 favors the hIVIG group.|Multiple imputation was used to estimate the outcome for one participant.|
1623105|NCT02287467|2979886|Superiority||Odds Ratio (OR)|0.94||||0.82|2-Sided|95.0|0.55|1.59|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio (hIVIG vs placebo) is for being in a better category.|Multiple imputation was used to estimate the outcome for 3 participants for whom the outcome was partially unknown.|
1623106|NCT02287467|2979887|Superiority||Odds Ratio (OR)|0.9||||0.73|2-Sided|95.0|0.5|1.62||adjusted for baseline clinical status, region, and participation in pilot study|Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio (hIVIG vs placebo) is for being in a better category. An odds ratio >1 favors the hIVIG group.||
1623107|NCT02287467|2979888|Superiority||Odds Ratio (OR)|1.32||||0.34|2-Sided|95.0|0.7|2.34|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is expressed as hIVIG vs placebo||
1623108|NCT02287467|2979889|Superiority||Odds Ratio (OR)|1.12||||0.77|2-Sided|95.0|0.5|2.31|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG vs placebo||
1623109|NCT02287467|2979890|Superiority||Odds Ratio (OR)|1.17||||0.55|2-Sided|95.0|0.7|1.95|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study|Odds ratio (hIVIG vs placebo) of being in a better category. An odds ratio > 1 favors the hIVIG group.|Proportional odds for being in a better category|
1623110|NCT02287467|2979891|Superiority||Odds Ratio (OR)|0.92||||0.81|2-Sided|95.0|0.5|1.82|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG group vs placebo||
1623111|NCT02287467|2979892|Superiority||Odds Ratio (OR)|0.97||||0.93|2-Sided|95.0|0.5|1.97|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study.|Odds ratio is for hIVIG vs placebo.||
1623112|NCT02287467|2979893|Superiority||Mean Difference (Net)|0.14||||0.49|2-Sided|95.0|-0.26|0.54|||Regression, Linear|Adjusted for baseline RNA, geographic region, and influenza subtype|Change is calculated as day 3 - baseline. Difference in changes is hIVIG - placebo.||
1623113|NCT02287467|2979894|Superiority||Odds Ratio (OR)|0.87||||0.74|2-Sided|95.0|0.38|1.98|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in pilot study|odds ratio is for hIVIG vs placebo; an odds ratio > 1.0 favors hIVIG||
1623114|NCT02287467|2979895|Superiority||Hazard Ratio (HR)|1.72||||0.4|2-Sided|95.0|0.48|6.15|||Regression, Cox|stratified by baseline clinical status, region, and participation in pilot study|hazard ratio is for hIVIG vs placebo; a hazard ratio < 1.0 favors the hIVIG group.||
1623115|NCT02287467|2979896|Superiority||Hazard Ratio (HR)|1.11||||0.44|2-Sided|95.0|0.85|1.45|||Regression, Cox|Stratified by baseline clinical status, region, and participation in the pilot study.|hazard ratio is hIVIG vs placebo; a hazard ratio >1 favors the hIVIG group.|Deaths during hospitalization are censored after day 7.|
1623116|NCT02287467|2979897|Superiority||Odds Ratio (OR)|1.49||||0.2|2-Sided|95.0|0.81|2.74|||Regression, Logistic|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio for hIVIG vs placebo. An odds ratio > 1.0 favors the hIVIG group.||
1623117|NCT02287467|2979898|Superiority||Odds Ratio (OR)|0.87||||0.52|2-Sided|95.0|0.57|1.33|||Regression, Cox|adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is for hIVIG vs. placebo. An odds ratio > 1 favors the hIVIG group.|Odds ratio for being in a better group, from a proportional odds model.|
1623118|NCT02287467|2979899|Superiority||Odds Ratio (OR)|0.95||||0.84|2-Sided|95.0|0.61|1.48|||Regression, Logistic|Adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is for hIVIG vs placebo. An odds ratio greater than 1 favors the hIVIG group.|Odds ratio for being in a better category, from a proportional odds model|
1623119|NCT02287467|2979900|Superiority||Odds Ratio (OR)|1.25||||0.33|2-Sided|95.0|0.79|1.97|||Regression, Logistic|Adjusted for baseline clinical status, region, and participation in the pilot study.|Odds ratio is hIVIG vs. placebo. A value greater than 1 favors the hIVIG group.|Odds ratio of being in a better category, as assessed using a proportional odds model. Multiple imputation techniques were used to impute an outcome for 4 patients for whom the outcome was unknown.|
1623120|NCT02286895|2980031|Superiority||geometric mean titer ratio|4.6|||||2-Sided|95.0|2.4|8.9||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1|
1623121|NCT02286895|2980032|Superiority||geometric mean titer ratio|2.0|||||2-Sided|95.0|1.2|3.3||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1|
1623122|NCT02286895|2980033|Superiority||geometric mean titer ratio|2.3|||||2-Sided|95.0|1.7|3.1||||||Null hypothesis: 28 days post-vaccination, geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1|
1623123|NCT02286895|2980034|Superiority||geometric mean titer ratio|1.7|||||2-Sided|95.0|1.2|2.4||||||Null hypothesis: geometric mean titer (GMT) in group receiving rotavirus vaccine/GMT in group not receiving rotavirus vaccine ≤ 1|
1623124|NCT02286895|2980035|Superiority||Mean Difference (Net)|52.0|||||2-Sided|95.0|37.7|66.3||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.|
1623125|NCT02286895|2980036|Superiority||Mean Difference (Net)|17.7|||||2-Sided|95.0|12.0|23.5||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.|
1623126|NCT02286895|2980037|Superiority||Mean Difference (Net)|31.1|||||2-Sided|95.0|23.1|39.0||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.|
1623176|NCT02285010|2980160|Non-Inferiority|alpha 0.05, beta 80%||||||0.16|||||||Chi-squared|||For pruritus|
1623127|NCT02286895|2980038|Superiority||Mean Difference (Net)|25.4|||||2-Sided|95.0|14.6|36.2||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.|
1623128|NCT02286895|2980039|Superiority||Mean Difference (Net)|15.8|||||2-Sided|95.0|8.1|23.4||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.|
1623129|NCT02286895|2980040|Superiority||Mean Difference (Net)|17.5|||||2-Sided|95.0|9.7|25.3||||||Null hypothesis: percentage of the seroresponse to rotavirus in the group that received rotavirus vaccine minus the percentage of the seroresponse to rotavirus in the group that did not receive rotavirus vaccine is less than or equal to 0.|
1623130|NCT02286895|2980041|Equivalence|Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1.|geometric mean titer ratio|0.9|||||2-Sided|95.0|0.7|1.3|||||||
1623131|NCT02286895|2980042|Equivalence|Definition of equivalence/null hypothesis: geometric mean concentration (GMC) of group receiving rotavirus vaccine/ GMC of group not receiving rotavirus vaccine = 1|geometric mean titer ratio|-0.7|||||2-Sided|95.0|-5.2|3.8|||||||
1623132|NCT02286895|2980043|Equivalence|Definition of equivalence/null hypothesis: geometric mean titer (GMT) of group receiving rotavirus vaccine divided by GMT of group not receiving rotavirus vaccine = 1.|geometric mean titer ratio|0.9|||||2-Sided|95.0|0.8|1.1|||||||
1623133|NCT02286895|2980044|Non-Inferiority|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was > -10%.|Mean Difference (Net)|-2.4|||||2-Sided|95.0|-7.5|2.7||||||Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.|
1623134|NCT02286895|2980045|Non-Inferiority|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% CI (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was > -10%.|Mean Difference (Net)|-4.1|||||2-Sided|95.0|-12.2|4.0||||||Based on results from a prior study completed by PATH and CVD-Mali, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.|
1623135|NCT02286895|2980046|Non-Inferiority|The protocol stated that non-inferiority would be achieved if the lower limit of the 95% confidence interval (2-sided) for the difference in sero-conversion percentages (group receiving rotavirus minus group not receiving rotavirus) was > –10%.|Mean Difference (Net)|0.1|||||2-Sided|95.0|-4.0|4.2||||||Based on results from a prior study, the sponsor assumed 90% sero-conversion rates in each Arms A and B for each antigen in the two co-primary objectives. To rule out a non-inferiority margin of no more than 10% with 95% power (95% power was chosen to give an overall power of at least 90%) and a one-sided type-one error rate of no more than 2.5%, 237 evaluable subjects were required in each group to explore the co-primary objectives.|
1623136|NCT02286466|2980064|Superiority||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.81||0.852|2-Sided|95.0|-1.45|1.75||a priori threshold p<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in depression symptoms on the PHQ-9 from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.|
1623137|NCT02286466|2980065|Superiority||Mean Difference (Final Values)|0.48|Standard Error of the Mean|0.55||0.379|2-Sided|95.0|-0.6|1.57||a priori threshold p<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in self-report depression symptoms on the HADS-Depression Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.|
1623138|NCT02286466|2980065|Superiority||Mean Difference (Final Values)|0.78|Standard Error of the Mean|0.63||0.215|2-Sided|95.0|-0.46|2.02||a priori threshold p<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in self-report anxiety symptoms on the HADS-Anxiety Subscale from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.|
1623139|NCT02286466|2980066|Superiority||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|2.51||0.997|2-Sided|95.0|-4.99|4.96||a priori threshold p<0.05|ANCOVA|Adjusted for baseline values of criterion outcome and psychotropic medication use||Analysis comparing the change in quality of life (FACT-G) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use|
1623140|NCT02286466|2980067|Superiority||Mean Difference (Final Values)|1.14|Standard Error of the Mean|1.38||0.412|2-Sided|95.0|-1.6|3.87||a priori threshold p<0.05|ANCOVA|Adjusted for baseline values of criterion outcomes and psychotropic medication use||Analysis comparing the change in anxiety symptoms (HAM-A) from baseline to post-assessment between groups adjusting for baseline values of criterion outcome and psychotropic medication use.|
1623141|NCT02285998|2980082|Non-Inferiority or Equivalence|The sample size required to achieve 80% power was calculated based on a one-sided alpha level of 0.025 and an attack rate of 2% in the IIV4 and 1.53% for the Flublok groups respectively.|Relative Vaccine Efficacy (rVE)|30.0|||||2-Sided|95.0|10.0|47.0||||||The primary efficacy analysis was based on the numbers of protocol-defined influenza-like illnesses with rtPCR-positive nasopharyngeal swabs detecting influenza virus of any strain. The Relative Vaccine Efficacy was 30% (10, 47). Non-inferiority would be concluded if the lower bound of the 95% CI for rVE was > -20%. Superiority of RIV4 in a pre-specified exploratory analysis required that the lower bound of the two-sided 95% CI of rVE be > +9%.|
1623177|NCT02285010|2980161|Non-Inferiority|alpha 0.05, beta 80%||||||0.75|||||||Wilcoxon (Mann-Whitney)|||for NRS at movement|
1623142|NCT02285777|2980125|Other|Pre-specified.|Vaccine Effectiveness|24.0||||0.0001||95.0|20.0|28.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION & LOG LINK options were used to compute log10 RR & corresponding CI.||The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as [1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)] x 100. The combined VE across all strains was computed by mean of a generalized linear model.|
1623143|NCT02285777|2980125|Other|Pre-specified.|Vaccine Effectiveness|51.0||||0.0001|2-Sided|95.0|48.0|54.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION & LOG LINK options were used to compute log10 RR & corresponding CI.||The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as [1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 dilution in MenACWY group)] x 100. The combined VE across all strains was computed by mean of a generalized linear model.|
1623144|NCT02285777|2980126|Other|Pre-specified.|Vaccine Effectiveness|51.0||||0.0001|2-Sided|95.0|48.0|55.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION & LOG LINK options were used to compute log10 RR & corresponding CI.||The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as [1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)] x 100. The combined VE across all strains was computed by mean of a generalized linear model.|
1623145|NCT02285777|2980127|Other|Pre-specified.|Vaccine Effectiveness|71.0||||0.0001|2-Sided|95.0|69.0|73.0|||Generalized Linear Model|To obtain the VE measure which is a measure based on RR, BINOMIAL DISTRIBUTION & LOG LINK options were used to compute log10 RR & corresponding CI.||The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as [1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:4 dilution in MenACWY group)] x 100.The combined VE across all strains was computed by mean of a generalized linear model.|
1623146|NCT02285634|2980128|Superiority|||||||0.47|||||||Fisher Exact||||
1623147|NCT02285634|2980128|Superiority|||||||0.1|||||||Fisher Exact||||
1623148|NCT02285634|2980128|Superiority|||||||0.78|||||||Fisher Exact||||
1623149|NCT02285634|2980129|Superiority|||||||0.56|||||||Fisher Exact||||
1623150|NCT02285634|2980129|Superiority|||||||0.17|||||||Fisher Exact||||
1623151|NCT02285634|2980129|Superiority|||||||0.27|||||||Fisher Exact||||
1623152|NCT02285634|2980130|Superiority|||||||0.78|||||||Fisher Exact||||
1623153|NCT02285634|2980130|Superiority|||||||0.61|||||||Fisher Exact||||
1623154|NCT02285634|2980130|Superiority|||||||0.06|||||||Fisher Exact||||
1623155|NCT02285634|2980131|Superiority|||||||0.93|||||||Fisher Exact||||
1623156|NCT02285634|2980131|Superiority|||||||0.52|||||||Fisher Exact||||
1623157|NCT02285634|2980131|Superiority|||||||0.42|||||||Fisher Exact||||
1623158|NCT02285153|2980135|Superiority|||||||0.467|||||||Chi-squared||||
1623159|NCT02285153|2980136|Superiority|||||||1|||||||Chi-squared||||
1623160|NCT02285153|2980137|Superiority|||||||0.057|||||||Chi-squared||||
1623161|NCT02285153|2980138|Superiority||Cox Proportional Hazard|0.434|Standard Error of the Mean|1.225||0.57|2-Sided|95.0|0.039|4.792||Due to the low number of participants, the results of the statistical tests must be interpreted with caution!|Chi-squared||||
1623162|NCT02285062|2980148|Superiority||Hazard Ratio (HR)|1.167||||0.315||95.0|0.856|1.59|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or < 7 cm), and age (< 65 or ≥ 65 years).|HR is derived from Cox model||
1623163|NCT02285062|2980149|Superiority||Hazard Ratio (HR)|0.776||||0.2143|2-Sided|95.0|0.521|1.157|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or < 7 cm), and age (< 65 or ≥ 65 years).|HR was derived from COX model adjusting for the 3 stratification factors mentioned above.||
1623164|NCT02285062|2980150|Superiority|||||||0.9964||||||Obtained from CMH test adjusting for stratification factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (< 65 or ≥ 65)|Cochran-Mantel-Haenszel||||
1623165|NCT02285062|2980151|Superiority|||||||0.2933||||||Obtained from CMH test adjusting for stratification factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (< 65 or ≥ 65)|Cochran-Mantel-Haenszel||||
1623166|NCT02285062|2980152|Superiority||Hazard Ratio (HR)|0.925||||0.6433|2-Sided|95.0|0.646|1.323|||Log Rank|Log-rank test stratified by 3 factors: IPI score (2 or ≥ 3), presence of bulky disease (bulky or nonbulky), and age (< 65 or ≥ 65).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors.||
1623167|NCT02285062|2980153|Superiority||Hazard Ratio (HR)|1.038||||0.7294|2-Sided|95.0|0.802|1.344|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or < 7 cm), and age (< 65 or ≥ 65 years).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors.||
1623168|NCT02285062|2980154|Superiority||Hazard Ratio (HR)|0.849||||0.2864|2-Sided|95.0|0.632|1.14|||Log Rank|Stratified by: IPI score (2 or ≥ 3), presence or absence of bulky disease (diameter of the lesion ≥ 7 cm or < 7 cm), and age (< 65 or ≥ 65 years).|Hazard ratio was derived from Cox proportional hazard model adjusting for the 3 stratification factors||
1623169|NCT02285023|2980157|Superiority or Other||Cronbach's alpha|0.94|||<|0.05|2-Sided||||||Crohbach's alpha||||
1623170|NCT02285023|2980158|Non-Inferiority or Equivalence|Principal component analysis with varimax rotation was employed. An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5.|||||<|0.01||||||An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5|exploratory factor analysis|An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5||Exploratory factor analysis|
1623178|NCT02285010|2980161|Non-Inferiority|alpha 0.05, beta 80%||||||0.33|||||||Wilcoxon (Mann-Whitney)|||for NRS at rest|
1623179|NCT02285010|2980162|Non-Inferiority|Alpha 0.05, Beta 80%||||||0.1|||||||Wilcoxon (Mann-Whitney)||||
1623180|NCT02285010|2980163|Non-Inferiority|Definition: 50% reduction of morphine consumption Type I error (alpha) 0.05, Type II error (beta) 80%||||||0.6|||||||Wilcoxon (Mann-Whitney)||||
1623181|NCT02284893|2980166|Superiority||Mean Difference (Final Values)|-20.9|Standard Error of the Mean|3.682||0.0001|||||||Mixed Models Analysis||||
1623182|NCT02284893|2980167|Superiority||Mean Difference (Final Values)|-1.35|Standard Error of the Mean|0.2891||0.0001|||||||Mixed Models Analysis||||
1623183|NCT02284893|2980168|Superiority||Risk Difference (RD)|12.2|Standard Error of the Mean|4.175||0.0034|||||||Regression, Logistic|the analysis was by Zhang et.al. method with adjustment for baseline A1c.The measure of interest is NOT odds ratio but Risk Difference.|||
1623184|NCT02284893|2980169|Superiority||Mean Difference (Final Values)|-0.34|Standard Error of the Mean|0.1001||0.0008|||||||Mixed Models Analysis||||
1623185|NCT02284867|2980174|Non-Inferiority or Equivalence|"Multivariable binary logistic regression was done to examine the relation between CD16+ NK and preterm labor as adjusted for other confounding factors the enter method was used to build the regression model.~A two-sided p-value <0.05 was considered statistically significant."|Odds Ratio (OR)|65.01|Standard Error of the Mean|1.14|<|0.0002|2-Sided|95.0|6.96|606.76||To our best of known , no previous human studies was analyzing this issue|Regression, Logistic|||"Categorical data were presented as number and percentage and differences were compared using the Pearson chi-squared test. Ordinal data were compared using the chi-squared test for trend~A two-sided p-value <0.05 was considered statistically significant."|
1623186|NCT02284568|2980188|Superiority||Risk Ratio (RR)|0.4|Standard Error of the Mean|0.11||0.001|2-Sided|95.0|0.26|0.69||significance at 0.05|negative binomial regression model||Laquinimod 0.6 mg vs. placebo risk ratio|This analysis was performed using baseline adjusted negative binomial regression model (SAS® PROC GENMOD) in which 1 contrast for comparing laquinimod 0.6 mg to placebo was constructed. In addition to the treatment group, the natural logarithm of T2 lesion volume at baseline, age at baseline and country/geographical region (CGR) were used as covariates.|
1623187|NCT02284568|2980189|Superiority||Mean Difference (Final Values)|-0.325|Standard Error of the Mean|0.2679||0.248|2-Sided|95.0|-0.85|0.2||significance at 0.05. The p-value for ranked change from baseline values was from a repeated measures analysis of covariance with trt group, week, treatment group by week interaction, rank of T25FW score at baseline, and country as fixed effects.|Repeated Measures ANCOVA||Laquinimod 0.6 mg vs. placebo treatment effect|placebo n=121 Laquinimod 0.6 mg n=108 The estimate of parameter, standard error, and 95% confidence intervals for change from baseline was from a Mann-Whitney-Wilcoxon Test using Hodges-Lehmann estimates.|
1623188|NCT02284568|2980190|Superiority||Hazard Ratio (HR)|1.0||||0.867|2-Sided|95.0|0.68|1.59||significance at 0.05.|Regression, Cox||Laquinimod 0.6 mg vs placebo|The statistical model was a Cox proportional hazards regression model with treatment group, categorical EDSS at baseline (≤4.5 or >4.5), age at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.|
1623189|NCT02284568|2980191|Superiority||Hazard Ratio (HR)|0.8||||0.426|2-Sided|95.0|0.48|1.37||significance at 0.05. p-value was from a log-rank test, and estimate and confidence limits were from a Cox model with treatment group as fixed effect, due to the violation of the proportionality assumption.|Log Rank||Laquinimod 0.6 mg vs placebo|The statistical model was a Cox proportional hazards regression model with treatment group, categorical EDSS at baseline (≤4.5 or >4.5), age at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.|
1623190|NCT02284568|2980193|Superiority||Mean Difference (Final Values)|0.016|Standard Error of the Mean|0.1293||0.903|2-Sided|95.0|-0.239|0.2705||significance at 0.05.|Repeated Measures ANCOVA|||The statistical model was a repeated measures analysis of covariance with treatment group, week, treatment group by week interaction, normalized brain volume at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects.|
1623191|NCT02284516|2980196|Superiority or Other||Treatment Effect|9.32|Standard Error of the Mean|1.976|<|0.0001|2-Sided|95.0|5.44|13.2||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance [ANOVA]).|ANOVA|||Baseline and Day 42|
1623192|NCT02284516|2980196|Superiority or Other||Treatment Effect|7.85|Standard Error of the Mean|1.792|<|0.0001|2-Sided|95.0|4.33|11.37||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance [ANOVA]).|ANOVA|||Baseline and Day 14|
1623193|NCT02284516|2980197|Superiority or Other||Treatment Effect|7.16|Standard Error of the Mean|2.096|=|0|2-Sided|95.0|3.04|11.28||The primary analysis was performed using a stratified 2-sample t-test (that is, analysis of variance [ANOVA]).|ANOVA||||
1623194|NCT02284243|2980221|Superiority or Other|||||||0.7718|||||||Cochran-Mantel-Haenszel||||
1623195|NCT02284243|2980222|Superiority or Other|||||||0.0009|||||||Log Rank||||
1623196|NCT02284243|2980224|Superiority or Other||||||<|0.05||||||Applies to ≥30% and ≥50% reduction in pain|Cochran-Mantel-Haenszel|Test for general association stratified by site|||
1623197|NCT02284243|2980225|Superiority or Other||||||<|0.05||||||Applies to perceptible and meaningful pain relief|Log Rank||||
1623198|NCT02284243|2980226|Superiority or Other||||||<|0.05||||||Applies to SPID 0-6, SPID 0-12, and SPID 0-24|ANCOVA||||
1623199|NCT02284243|2980227|Superiority or Other|||||||0.018|||||||ANCOVA||||
1623200|NCT02284178|2980228|Superiority|||||||0.05|||||||t-test, 2 sided||||
1623201|NCT02284178|2980229|Superiority|||||||0.155|||||||t-test, 2 sided||||
1623202|NCT02284178|2980230|Superiority|||||||0.214|||||||t-test, 2 sided||||
1623203|NCT02284178|2980231|Superiority|||||||0.46|||||||GEE analysis||||
1623204|NCT02284178|2980233|Superiority|||||||0.858|||||||Chi-squared||||
1623205|NCT02284178|2980234|Superiority|||||||0.684|||||||GEE||||
1623206|NCT02284178|2980235|Superiority|||||||0.432|||||||GEE analysis||||
1623207|NCT02284009|2980262|Superiority||Mean Difference (Final Values)|0.12|||||2-Sided|95.0|0.0|0.24|||||Analysis was performed using a Bayesian model incorporating historical placebo data using a robust mixture prior. Values above are 95% credible intervals. Probability of treatment difference (Albiglutide – Placebo) >= 0.2 nmol/L = 0.097.||
1623951|NCT02263326|2981800|Other|||||||0.42|||||||Wilcoxon (Mann-Whitney)||||
1623208|NCT02283762|2980275|Superiority|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|-0.2||||0.901|2-Sided|95.0|-3.4|3.0|||MMRM (Method 1)|||change from baseline|
1623209|NCT02283762|2980276|Superiority|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|0.83||||0.0241|2-Sided|95.0|0.11|1.54|||MMRM (Method 1)|||Change from baseline|
1623210|NCT02283762|2980277|Superiority|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|0.79||||0.0887|2-Sided|95.0|-0.12|1.69|||MMRM (Method 1)|||Change from baseline|
1623211|NCT02283762|2980278|Superiority|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|Difference in LS means|-0.07||||0.3529|2-Sided|95.0|-0.23|0.08|||MMRM (Method 1)|||change from baseline|
1623212|NCT02283762|2980279|Superiority|The pre-specified test was for superiority but ONLY if the primary endpoint and secondary endpoints were meeting statistical significance (hierarchical testing).|%|0.2||||0.977|2-Sided|95.0|-13.68|14.09|||Mantel Haenszel||||
1623213|NCT02283762|2980280|Superiority||Difference of LS means|-2.34||||0.0815|2-Sided|95.0|-4.99|0.3|||MMRM (Method 1)||||
1623214|NCT02282813|2980335|Superiority or Other|||||||0.8086|||||||Cochran-Mantel-Haenszel||||
1623215|NCT02282813|2980336|Superiority or Other|||||||0.4817|||||||Cochran-Mantel-Haenszel||||
1623216|NCT02282813|2980337|Superiority or Other|||||||0.0503|||||||Cochran-Mantel-Haenszel||||
1623217|NCT02282813|2980338|Superiority or Other|||||||0.1041|||||||Cochran-Mantel-Haenszel||||
1623218|NCT02282631|2980351|Superiority or Other|||||||0.01||||||"U=955.0 Z=-2.5 p=0.01~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)||||
1623219|NCT02282631|2980352|Superiority or Other|||||||0.02||||||"U=596.5 Z=-2.4 p=0.02~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)||||
1623220|NCT02282631|2980353|Superiority or Other|||||||0.02||||||"U=665.5 Z=-2.3 p=0.02~The mean and SD values are provided for descriptive purposes only."|Wilcoxon (Mann-Whitney)||||
1623221|NCT02282631|2980354|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|"U=390.5 Z=-2.3 p=0.02~The mean and SD values are provided for descriptive purposes only."|||
1623222|NCT02282605|2980368|Superiority or Other|||||||0.005||||||The adjusted means were compared for the two-day treatment period through to discharge|ANCOVA||||
1623223|NCT02282605|2980368|Superiority or Other||||||<|0.001||||||The adjusted means were compared for the two-day treatment period to discharge.|ANCOVA||||
1623224|NCT02282605|2980368|Superiority or Other||||||<|0.028||||||The adjusted means were compared for the two-day treatment period.|ANCOVA||||
1623225|NCT02282605|2980370|Superiority or Other|||||||0.0058||||||For timepoint Day 3 (12 hours after last dose)|Fisher Exact||||
1623226|NCT02282605|2980371|Superiority or Other|||||||0.887|||||||Fisher Exact||||
1623227|NCT02282605|2980371|Superiority or Other|||||||0.792|||||||Fisher Exact||||
1623228|NCT02282293|2980376|Other||Risk Ratio (RR)|1.33||||0.35|2-Sided|95.0|0.72|2.45|||Chi-squared||||
1623229|NCT02282293|2980377|Other||Risk Ratio (RR)|0.45||||0.19|2-Sided|95.0|0.13|1.48||Calculated p-value|GEE||||
1623230|NCT02282293|2980379|Other||Risk Ratio (RR)|1.96||||0.5|2-Sided|95.0|0.5|7.61|||Chi-squared||||
1623231|NCT02282293|2980381|Other||Risk Ratio (RR)|1.96||||0.5|2-Sided|95.0|0.5|7.61||Calculated p-value|Chi-squared||||
1623232|NCT02282020|2980389|Superiority||Hazard Ratio (HR)|0.48||||0.002|2-Sided|95.0|0.3|0.76|||Log Rank||||
1623233|NCT02282020|2980390|Superiority||Hazard Ratio (HR)|0.44|||<|0.001|2-Sided|95.0|0.3|0.66|||Log Rank||||
1623234|NCT02282020|2980391|Superiority||Hazard Ratio (HR)|0.14|||<|0.001|2-Sided|95.0|0.1|0.22|||Log Rank||||
1623235|NCT02282020|2980392|Superiority||Hazard Ratio (HR)|1.11||||0.69|2-Sided|95.0|0.67|1.83|||Log Rank||||
1623236|NCT02282020|2980393|Superiority||Hazard Ratio (HR)|0.83||||0.393|2-Sided|95.0|0.53|1.28|||Log Rank||||
1623237|NCT02282020|2980394|Superiority||Hazard Ratio (HR)|0.62||||0.014|2-Sided|95.0|0.42|0.91|||Log Rank||||
1623238|NCT02282020|2980395|Superiority||Odds Ratio (OR)|2.4||||0.004|2-Sided|95.0|1.32|4.39|||Regression, Logistic||||
1623239|NCT02282020|2980396|Superiority||Odds Ratio (OR)|2.24||||0.092|2-Sided|95.0|0.88|6.86|||Regression, Logistic||||
1623240|NCT02282020|2980397|Superiority||Hazard Ratio (HR)|0.62||||0.108|2-Sided|95.0|-0.5|5.5|||Regression, Logistic||||
1623241|NCT02282020|2980400|Superiority||Hazard Ratio (HR)|0.17|||<|0.001|2-Sided|95.0|0.11|0.25|||Log Rank||||
1623242|NCT02282020|2980401|Superiority||Hazard Ratio (HR)|0.49||||0.002|2-Sided|95.0|0.31|0.77|||Log Rank||||
1623243|NCT02282020|2980402|Superiority||Hazard Ratio (HR)|0.48|||<|0.001|2-Sided|95.0|0.33|0.71|||Log Rank||||
1623244|NCT02282020|2980403|Superiority||Hazard Ratio (HR)|0.59||||0.005|2-Sided|95.0|0.41|0.85|||Log Rank||||
1623245|NCT02282020|2980404|Superiority||Hazard Ratio (HR)|1.07||||0.78|2-Sided|95.0|0.65|1.76|||Log Rank||||
1623246|NCT02282020|2980405|Superiority||Hazard Ratio (HR)|0.81||||0.354|2-Sided|95.0|0.52|1.26|||Log Rank||||
1623247|NCT02282020|2980406|Superiority||Hazard Ratio (HR)|0.62||||0.013|2-Sided|95.0|0.43|0.91|||Log Rank||||
1623248|NCT02282020|2980407|Superiority||Odds Ratio (OR)|2.53||||0.002|2-Sided|95.0|1.4|4.58|||Regression, Logistic||||
1623284|NCT02280408|2980533|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed|||
1623285|NCT02280408|2980533|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed|||
1623286|NCT02280408|2980533|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed|||
1623287|NCT02280408|2980533|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed|||
1623288|NCT02280408|2980534|Other|||||||0.969|||||||ANOVA|Adjustments for multiple comparisons were not performed|||
1623249|NCT02281773|2980412|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.06||0.3901|2-Sided|95.0|-0.1|0.2||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between−group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1623250|NCT02281773|2980412|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.06||0.3027|2-Sided|95.0|-0.1|0.2||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between−group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1623251|NCT02281773|2980412|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.06||0.9919|2-Sided|95.0|-0.1|0.1||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between−group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1623252|NCT02281773|2980412|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.06||0.9399|2-Sided|95.0|-0.1|0.1||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between−group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1623253|NCT02281773|2980413|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.66||0.7507|2-Sided|95.0|-1.1|1.5||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between−group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1623254|NCT02281773|2980413|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.68||0.48|2-Sided|95.0|-0.9|1.8||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between−group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1623255|NCT02281773|2980413|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.68||0.3817|2-Sided|95.0|-1.9|0.7||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between−group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1623256|NCT02281773|2980413|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.66||0.5972|2-Sided|95.0|-0.9|1.6||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|ANCOVA||Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|Analyses of covariance (ANCOVA) were used to assess between−group differences (BI 409306 group minus placebo group) in the modelled changes from baseline to Week 12. The dependent variable was the change from the baseline score at Week 12 during the treatment period adjusted for fixed categorical covariates of treatment as well as fixed continuous covariates of baseline score.|
1623257|NCT02281773|2980418|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.79||0.427|2-Sided|95.0|-2.19|0.93||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward−Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 100 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.|
1623289|NCT02280408|2980534|Other|||||||0.011|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623258|NCT02281773|2980418|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.83||0.6994|2-Sided|95.0|-1.31|1.95||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward−Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 50 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.|
1623259|NCT02281773|2980418|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.8||0.7337|2-Sided|95.0|-1.3|1.84||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward−Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 25 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.|
1623260|NCT02281773|2980418|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.79||0.1256|2-Sided|95.0|-2.76|0.34||Due to the exploratory nature of this trial, no multiplicity adjustment was made. All statistical testing was performed using a two-sided, α=0.05 level of significance.|Mixed Models Analysis|Unstructured covariance structure has been used to fit the mixed model. Kenward−Roger was used to model degrees of freedom.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as BI 409306 10 mg minus Placebo.|The restricted maximum likelihood (REML) based mixed effects model with repeated measurements (MMRM) was used with baseline value as fixed covariate and planned treatment, analysis visit, first test done, geographic region grouping 1, planned treatment by analysis visit and baseline value by analysis visit as fixed effects.|
1623261|NCT02281552|2980439|Non-Inferiority|Non-inferiority of tofacitinib MR 11 mg QD to IR 5 mg BID was concluded if the upper bound of the 2-sided 95% confidence interval of differences between the treatment groups (MR 11 mg QD – IR 5 mg BID) at Week 12 was less than the pre-specified non-inferiority margin of 0.6.|Least Square (LS) mean difference|0.43|Standard Error of the Mean|0.13|||2-Sided|95.0|0.17|0.69||||||Analysis was conducted using a linear mixed effect model with repeated measures (MMRM), which included treatment (tofacitinib MR 11 mg QD and IR 5 mg BID), visit, and treatment by visit interaction as fixed effects and participants as a random effect.|
1623262|NCT02281357|2980449|Superiority||Rate Ratio|0.8||||0.186|2-Sided|95.0|0.57|1.12|||Negative binomial||Treatment group, OCS dose at baseline, and number of exacerbations in the previous year are included in the model as covariates.|Comparison of AAER: tralokinumab vs placebo.|
1623263|NCT02281357|2980450|Superiority||Odds Ratio (OR)|1.38||||0.356|2-Sided|95.0|0.7|2.74|||Regression, Logistic|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate.||Comparison of ≥50% reduction in OCS dose: tralokinumab vs placebo.|
1623264|NCT02281357|2980451|Superiority||Odds Ratio (OR)|1.33||||0.442|2-Sided|95.0|0.65|2.73|||Regression, Logistic|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate.||Comparison of OCS dose ≤5.0 mg: tralokinumab vs placebo.|
1623265|NCT02281357|2980452|Superiority|The null hypothesis was that the average percentage change in OCS dose on tralokinumab was equal to the average percentage change in OCS dose on placebo.|LS Mean difference|-7.78||||0.271|2-Sided|95.0|-21.7|6.15|||ANCOVA|The analysis of covariance (ANCOVA) model utilised a sandwich estimator for the variance.|The model included treatment group as a fixed effect and baseline OCS dose as a continuous covariate. No interaction terms were included in the model. All group comparisons from the ANCOVA model were based on Type III sums of squares.|Comparison of percent change from baseline in OCS dose: tralokinumab vs placebo.|
1623266|NCT02281318|2980453|Superiority or Other||Mean Difference (Final Values)|-0.4|||<|0.001|2-Sided|95.0|-0.58|-0.22|||Mixed model repeated measures analysis||||
1623267|NCT02281318|2980454|Superiority or Other||Odds Ratio (OR)|2.23|||<|0.001|2-Sided|95.0|1.55|3.22|||Regression, Logistic||||
1623268|NCT02281318|2980455|Superiority or Other||Mean Difference (Final Values)|120.0||||0.001|2-Sided|95.0|47.0|192.0|||Mixed model repeated measures analysis||||
1623269|NCT02281318|2980456|Superiority or Other||Mean Difference (Final Values)|-7.7|||<|0.001|2-Sided|95.0|-10.5|-4.9|||Mixed model repeated measures analysis||||
1623270|NCT02280408|2980531|Other|||||||0.923|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623271|NCT02280408|2980531|Other|||||||0.011|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623272|NCT02280408|2980531|Other|||||||0.014|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623273|NCT02280408|2980531|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623274|NCT02280408|2980531|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623275|NCT02280408|2980531|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623276|NCT02280408|2980532|Other|||||||0.743|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623277|NCT02280408|2980532|Other|||||||0.07|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623278|NCT02280408|2980532|Other|||||||0.132|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623279|NCT02280408|2980532|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623280|NCT02280408|2980532|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623281|NCT02280408|2980532|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623282|NCT02280408|2980533|Other|||||||0.733|||||||ANOVA|Adjustments for multiple comparisons were not performed|||
1623283|NCT02280408|2980533|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed|||
1623290|NCT02280408|2980534|Other|||||||0.01|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623291|NCT02280408|2980534|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623292|NCT02280408|2980534|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623293|NCT02280408|2980534|Other||||||<|0.001|||||||ANOVA|Adjustments for multiple comparisons were not performed.|||
1623294|NCT02280304|2980543|Other||Slope|0.02|||<|0.000149|2-Sided|||||Cluster in the right cerebellum (crus 2) p<0.000149 FDR corrected for multiple comparisons across the whole brain. Bonferroni for multiple seeds p=0.008.|Regression, Linear|Significance is determined when voxel (height) threshold p=.001, cluster threshold p=.05, FDR corrected for multiple tests across the whole brain.||The extent of community participation prior to therapy was correlated with the functional connectivity of the right hippocampus seed after therapy (post-pre).|
1623295|NCT02280304|2980543|Other||Slope|0.02|||<|3.8e-05|2-Sided|||||Cluster in MPFC p<0.000038 FDR corrected for multiple comparisons across whole brain. Bonferroni correction for multiple seeds p=0.008.|Regression, Linear|Significance is determined when voxel (height) threshold p=.001, cluster threshold p=.05, FDR corrected for multiple tests across the whole brain.||The extent of community participation prior to therapy was correlated with the functional connectivity of the right hippocampus seed after therapy (post-pre).|
1623296|NCT02280304|2980544|Superiority||||||<|0.02||||||The p-value obtained for the L anterior PGH seed/left VMPC cluster is 0.02. The critical p-value after Bonferroni correction for six seeds is p=.008.|t-test, 2 sided|Significance is determined when clusters reach voxel threshold p<.001, cluster p<.05 FDR corrected for multiple comparisons across the whole brain.|||
1623297|NCT02280304|2980544|Superiority||||||<|0.0099||||||The p-value obtained for the L PHG seed/L IPL cluster is 0.0099. The critical p-value after Bonferroni correction for multiple seeds is p=.008.|t-test, 2 sided|Significance is determined when clusters reach voxel threshold p<.001, cluster p<.05 FDR corrected for multiple comparisons across the whole brain.|||
1623298|NCT02280304|2980545|Other||Cohens d|0.27|||||2-Sided||||||||Cohen's d effect size (Cohen's d =0.20 is a small effect; Cohen's d=0.50 is a medium effect; Cohen's d=0.80 is a large effect.)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.|
1623299|NCT02280304|2980545|Other||Cohens d|1.32|||||2-Sided||||||||Cohen's d effect size change (Cohen's d =0.20 is a small effect; Cohen's d=0.50 is a medium effect; Cohen's d=0.80 is a large effect.)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.|
1623300|NCT02280304|2980546|Other||Cohens d|0.3|||||2-Sided||||||||Cohen's d effect size (Cohen's d=.20 small, Cohen's d=.50 medium, Cohen's d=.80 large)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.|
1623301|NCT02280304|2980546|Other||Cohens d|0.86|||||2-Sided||||||||Cohen's d effect size (Cohen's d=.20 small, Cohen's d=.50 medium, Cohen's d=.80 large)|Cohen's d effect sizes are reported for changes over time (0 weeks vs. 12 weeks) in each group separately.|
1623302|NCT02280304|2980547|Other||Cohens d|0.13|||||2-Sided||||||||||
1623303|NCT02280304|2980547|Other||Mean Difference (Net)|0.6|||||2-Sided||||||||||
1623304|NCT02280304|2980547|Other||Cohens d|0.29|||||2-Sided||||||||||
1623305|NCT02280304|2980547|Other||Mean Difference (Net)|1.3|||||2-Sided||||||||||
1623306|NCT02280304|2980547|Other||Cohens d|0.53|||||2-Sided||||||||||
1623307|NCT02280304|2980547|Other||Mean Difference (Net)|1.8|||||2-Sided||||||||||
1623308|NCT02280304|2980547|Other||Cohen's d|0.2|||||2-Sided||||||||Cohens d reflects the Cris pre post Perceived Limitations scale||
1623309|NCT02280304|2980547|Other||Median Difference (Net)|0.8|||||2-Sided||||||||||
1623310|NCT02280304|2980547|Other||Cohen's d|0.14|||||2-Sided||||||||Cohen's d reflects Extent of Participation Scale of the Cris pre- post||
1623311|NCT02280304|2980547|Other||Median Difference (Net)|0.8|||||2-Sided||||||||||
1623312|NCT02280304|2980547|Other||Cohen's d|0.35|||||2-Sided||||||||Cohen's d reflects Extent of Participation subscale of the CRIS, Post - Pre||
1623313|NCT02280304|2980547|Other||Mean Difference (Net)|1.8|||||2-Sided||||||||||
1623314|NCT02280304|2980548|Superiority||||||>|0.05||||||A priori threshold = voxel p<.001, cluster p<.05, FDR whole brain correction. There is no correction for multiple seeds given small sample sizes and pre-post design. To report NS p-values and associated z-scores, uncorrected cluster ps were queried.|t-test, 1 sided|||Z-scores represent Fisher transformed correlation coefficients representing the correlations between hypothesized regions. Positive values represents positive connectivity between regions. Negative values represent anticorrelations, or negative relations, between hypothesized regions.|
1623315|NCT02280096|2980577|Superiority||t-boostrap|0.001||||0.001|2-Sided||||||t-test, 1 sided|||Problem-solving time|
1623316|NCT02280096|2980577|Superiority||t-boostrap|0.001||||0.001|2-Sided||||||t-test, 1 sided|||Execution time|
1623317|NCT02280096|2980578|Superiority||t-boostrap|0.01||||0.01|2-Sided||||||t-test, 1 sided|||Correct moves|
1623318|NCT02280096|2980578|Superiority||t-boostrap|0.017||||0.017|2-Sided||||||t-test, 1 sided|||Total moves|
1623319|NCT02280096|2980579|Superiority||t-boostrap|0.92||||0.92|1-Sided||||||t-test, 1 sided||||
1623320|NCT02280096|2980580|Superiority||t-boostrap|0.83||||0.83|2-Sided||||||t-test, 1 sided||||
1623321|NCT02280096|2980581|Superiority||t-boostrap|0.9||||0.9|2-Sided||||||t-test, 1 sided|||Alternation|
1623322|NCT02280096|2980581|Superiority||t-boostrap|0.43||||0.43|2-Sided||||||t-test, 1 sided|||Count speed|
1623323|NCT02280096|2980581|Superiority||t-boostrap|0.64||||0.64|1-Sided||||||t-test, 1 sided|||Reading speed|
1623324|NCT02280096|2980582|Superiority||t-boostrap|0.016||||0.016|2-Sided||||||t-test, 1 sided||||
1623325|NCT02280096|2980583|Superiority||t-boostrap|0.001||||0.001|1-Sided||||||t-test, 1 sided||||
1623326|NCT02280096|2980584|Superiority||t-boostrap|0.028||||0.028|2-Sided||||||t-test, 1 sided||||
1623327|NCT02279641|2980600|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|101.0|||||2-Sided|95.0|86.7|117.0|||||||
1623328|NCT02279641|2980601|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||2-Sided|95.0|88.4|104.0|||||||
1623329|NCT02279641|2980602|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||2-Sided|95.0|88.4|104.0|||||||
1623330|NCT02279641|2980603|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|98.7|||||2-Sided|95.0|87.7|111.0|||||||
1623331|NCT02279641|2980606|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|105.0|||||2-Sided|90.0|94.4|117.0|||||||
1623332|NCT02279641|2980606|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|193.0|||||2-Sided|90.0|177.0|210.0|||||||
1623333|NCT02279641|2980606|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|87.5|||||2-Sided|90.0|79.3|96.6|||||||
1623334|NCT02279641|2980607|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|119.0|||||2-Sided|90.0|114.0|125.0|||||||
1623335|NCT02279641|2980607|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|89.5|||||2-Sided|90.0|81.8|98.0|||||||
1623336|NCT02279641|2980609|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|61.8|||||2-Sided|90.0|58.1|65.7|||||||
1623337|NCT02279641|2980609|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|103.0|||||2-Sided|90.0|94.9|112.0|||||||
1623338|NCT02279641|2980610|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.9|||||2-Sided|90.0|88.4|104.0|||||||
1623339|NCT02279641|2980610|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|61.8|||||2-Sided|90.0|58.1|65.7|||||||
1623340|NCT02279641|2980610|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|102.0|||||2-Sided|90.0|93.3|111.0|||||||
1623341|NCT02279641|2980612|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|67.9|||||2-Sided|90.0|65.2|70.7|||||||
1623342|NCT02279641|2980612|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|133.0|||||2-Sided|90.0|111.0|159.0|||||||
1623343|NCT02279407|2980617|Superiority or Other||Geometric mean ratio for difference|0.91||||0.562|2-Sided|95.0|0.73|1.13||Conditional upon rejection of at least 1 of the hypotheses for the primary analysis, secondary hypotheses are tested using Tukey's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons.|Mixed Models Analysis||||
1623344|NCT02279407|2980617|Superiority or Other||Geometric mean ratio for difference|0.91||||0.502|2-Sided|95.0|0.75|1.11||Conditional upon rejection of at least 1 of the 3 hypotheses for the primary analysis, secondary hypotheses are tested using Tukey's multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons.|Mixed Models Analysis||||
1623345|NCT02279407|2980618|Superiority or Other||Geometric mean ratio for difference|0.83||||0.046|2-Sided|95.0|0.7|1.0||Hypotheses tested using Dunnett’s multiple testing procedure with a family-wise error rate of 5%, adjusting for 3 pairwise comparisons versus a single control (placebo).|Mixed Models Analysis||||
1623346|NCT02279043|2980641|Superiority||Odds Ratio (OR)|1.24||||0.33|2-Sided|95.0|0.08|1.93|||Regression, Logistic||||
1623347|NCT02279043|2980642|Superiority||Odds Ratio (OR)|1.19||||0.68|2-Sided|95.0|0.52|2.74|||Regression, Logistic||||
1623348|NCT02279043|2980643|Superiority||Odds Ratio (OR)|1.02||||0.93|2-Sided|95.0|0.52|2.74|||Regression, Logistic||||
1623349|NCT02279043|2980644|Superiority||Slope|0.84|||<|0.01|2-Sided|95.0|0.33|1.35|||Mixed Models Analysis|Mixed effects logistic regression||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.|
1623350|NCT02279043|2980644|Superiority||Odds Ratio (OR)|2.25|||<|0.01|2-Sided|95.0|1.42|3.56|||Regression, Logistic||||
1623351|NCT02279043|2980645|Superiority||Slope|0.5||||0.03|2-Sided|95.0|0.04|0.97|||Mixed Models Analysis|Mixed effects logistic regression||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.|
1623352|NCT02279043|2980645|Superiority||Odds Ratio (OR)|1.63||||0.03|2-Sided|95.0|1.05|2.58|||Regression, Logistic||||
1623353|NCT02279043|2980646|Superiority||Odds Ratio (OR)|1.48||||0.08|2-Sided|95.0|0.95|2.29|||Regression, Logistic||||
1623354|NCT02279043|2980647|Superiority||Odds Ratio (OR)|1.0||||0.99|2-Sided|95.0|0.49|2.05|||Regression, Logistic||||
1623355|NCT02279043|2980648|Superiority||Odds Ratio (OR)|1.29||||0.34|2-Sided|95.0|0.75|2.2|||Regression, Logistic||||
1623356|NCT02279043|2980649|Superiority|||||||0.08|||||||t-test, 2 sided||||
1623357|NCT02279043|2980650|Superiority|||||||0.59|||||||t-test, 2 sided||||
1623358|NCT02279043|2980651|Superiority||Slope|0.59||||0.02|2-Sided|95.0|0.08|1.11|||Regression, Linear|||Multivariate analysis adjusting for cluster, as association was significant in bivariate test.|
1623359|NCT02279043|2980651|Superiority|||||||0.03|||||||t-test, 2 sided||||
1623360|NCT02279043|2980652|Superiority|||||||0.28|||||||t-test, 2 sided||||
1623361|NCT02279043|2980653|Superiority||Odds Ratio (OR)|0.88||||0.89|2-Sided|95.0|0.16|4.88|||Regression, Logistic||||
1623362|NCT02278952|2980654|Other|Generalized-estimating equation-adjusted linear models||||||0.456|||||||GEE-adjusted linear models|||P-value of mycophenolate mofetil dose|
1623363|NCT02278952|2980654|Other|Generalized estimating equation-adjusted linear models||||||0.037|||||||GEE-adjusted linear models|||P-value of Prednisone dose|
1623364|NCT02278952|2980654|Other|Generalized estimating equation-adjusted linear models||||||0.47|||||||GEE-adjusted linear models|||P-value of tacrolimus dose|
1623365|NCT02278952|2980655|Other|Generalized estimating equation-adjusted linear models||||||0.114|||||||GEE-adjusted linear models||||
1623952|NCT02263326|2981801|Other|||||||0.613|||||||Wilcoxon (Mann-Whitney)||||
1623366|NCT02278952|2980656|Other|Generalized estimating equation-adjusted linear models||||||0.049|||||||GEE-adjusted linear models||||
1623367|NCT02278952|2980657|Other|Generalized estimating equation-adjusted linear model|||||<|0.0001|||||||GEE-adjusted linear model||||
1623368|NCT02278952|2980658|Other|Generalized estimating equation-adjusted linear models||||||0.33|||||||GEE-adjusted models||||
1623369|NCT02278939|2980659|Superiority|||||||0.002||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for differences in group sample sizes|ANOVA|||Hypothesis: the intervention group will have a statistically greater reduction in BMI compared to the control from baseline to 3 months|
1623370|NCT02278939|2980660|Superiority|||||||0.001||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes|ANOVA|||Hypothesis: the intervention group will have a statistically greater reduction in percent weight compared to the control from baseline to 3-months|
1623371|NCT02278939|2980661|Superiority|||||||0.003||||||This was an intention to treat analysis using the Tukey-Kramer adjustment to account for unequal group sample sizes|ANOVA|||Hypothesis: the intervention group will have a significantly greater reduction in weight (kg) compared to the control from baseline to 3-months|
1623372|NCT02278614|2980671|Other|The change from baseline in mean IOP on D42 for the worse eye|Adjusted mean difference|-0.19|Standard Error of the Mean|0.25|||2-Sided|95.0|-0.69|0.31|||||||
1623373|NCT02278614|2980671|Other|The change from baseline in mean IOP on Day 84 for the contralateral eye,|Adjusted mean difference|-0.07|Standard Error of the Mean|0.26|||2-Sided|95.0|-0.57|0.43|||||||
1623374|NCT02278562|2980674|Superiority|||||||0.955||||||0.05 is the a priori threshold for statistical significance|Wilcoxon Rank-Sum|||Prior data indicate that LDR is normally distributed with standard deviation ranging from 0.16 to 0.23 in hemodialysis and control patients, respectively. If the true difference in the experimental and control means is 0.21, we will be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.933.|
1623375|NCT02278562|2980674|Superiority|||||||0.37||||||0.05 is the a priori threshold for statistical significance|Wilcoxon Rank-Sum|||Prior data indicate that LDR is normally distributed with standard deviation ranging from 0.16 to 0.23 in hemodialysis and control patients, respectively. If the true difference in the experimental and control means is 0.21, we will be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.933. The Type I error probability associated with this test of this null hypothesis is 0.05.|
1623376|NCT02278484|2980676|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1623377|NCT02278263|2980699|Superiority||||||<|0.05|||||||ANOVA|||Assuming a common standard deviation of 412 mL, to detect a difference of 300 mL of blood loss between the two treatment arms (sTXA and tTXA) and the placebo group, a sample size of 125 participants is required for a statistical power of 0.85, and a type I error of 0.05. The sample size required was 125 participants in total. The was increased by 15% to allow for expected dropouts. Therefore, a minimum of 147 patients was required for the study.|
1623378|NCT02278120|2980713|Superiority|||||||0.002|||||||Cochran-Mantel-Haenszel||||
1623379|NCT02278120|2980714|Superiority|||||||0.00098|||||||Cochran-Mantel-Haenszel||||
1623380|NCT02278120|2980716|Superiority||Hazard Ratio, log|0.553|||<|1e-07|2-Sided|95.0|0.441|0.694|||Log Rank||||
1623381|NCT02277990|2980719|Superiority||Hazard Ratio (HR)|0.63||||0.0402|2-Sided|95.12|0.4|0.98|||Regression, Cox||||
1623382|NCT02277990|2980720|Non-Inferiority|The non-inferiority test was performed on the as-treated cohort, per the statistical analysis plan. The non-inferiority margin for the hazard ratio was 1.33 (i.e., the hazard ratio for complications in the envelope group vs. the control group must be significantly lower than 1.33).|Hazard Ratio (HR)|0.93|||<|0.01|2-Sided|95.12|0.77|1.12|||Regression, Cox||||
1623383|NCT02277990|2980721|Superiority||Hazard Ratio (HR)|0.67||||0.0248|2-Sided|95.12|0.47|0.96|||Regression, Cox||||
1623384|NCT02277990|2980722|Superiority||Hazard Ratio (HR)|0.6||||0.0406|2-Sided|95.12|0.36|0.98||The 0.05 critical value for assessing the primary endpoint was adjusted to 0.0488, to account for a planned interim analysis.|Regression, Cox|The Cox regression was stratified according to device type (pacemaker or CRT-P vs. ICD or CRT-D).|||
1623385|NCT02277925|2980723|Superiority||Mean Difference (Final Values)|-4.5||||0.39|2-Sided|95.0|-14.7|5.7|||t-test, 2 sided||||
1623386|NCT02277925|2980724|Superiority||Risk Ratio (RR)|1.03||||0.43|2-Sided|95.0|0.96|1.11|||Chi-squared||||
1623387|NCT02277925|2980725|Superiority||Risk Ratio (RR)|1.74||||0.3|2-Sided|95.0|0.59|5.14|||Chi-squared||||
1623388|NCT02277769|2980729|Superiority||LS mean difference|-15.0|||<|0.0001|2-Sided|95.0|-19.16|-10.78||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623389|NCT02277769|2980729|Superiority||LS mean difference|-17.7|||<|0.0001|2-Sided|95.0|-21.96|-13.53||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623390|NCT02277769|2980730|Superiority||LS mean difference|-28.9|||<|0.0001|2-Sided|95.0|-35.03|-22.74||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623391|NCT02277769|2980730|Superiority||LS mean difference|-27.7|||<|0.0001|2-Sided|95.0|-33.73|-21.7||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623392|NCT02277769|2980731|Superiority||LS mean difference|-4.9|||<|0.0001|2-Sided|95.0|-6.04|-3.81||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623393|NCT02277769|2980731|Superiority||LS mean difference|-4.2|||<|0.0001|2-Sided|95.0|-5.34|-3.09||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623394|NCT02277769|2980732|Superiority||LS mean difference|-8.0|||<|0.0001|2-Sided|95.0|-9.36|-6.64||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623395|NCT02277769|2980732|Superiority||LS mean difference|-7.0|||<|0.0001|2-Sided|95.0|-8.36|-5.57||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623396|NCT02277769|2980733|Superiority||LS mean difference|-5.9|||<|0.0001|2-Sided|95.0|-7.1|-4.72||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623397|NCT02277769|2980733|Superiority||LS mean difference|-5.7|||<|0.0001|2-Sided|95.0|-6.86|-4.47||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623398|NCT02277769|2980734|Superiority||LS mean difference|-33.8|||<|0.0001|2-Sided|95.0|-39.75|-27.8||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623399|NCT02277769|2980734|Superiority||LS mean difference|-31.4|||<|0.0001|2-Sided|95.0|-37.36|-25.4||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623400|NCT02277769|2980735|Superiority||LS mean difference|-19.51|||<|0.0001|2-Sided|95.0|-23.491|-15.529||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623401|NCT02277769|2980735|Superiority||LS mean difference|-17.99|||<|0.0001|2-Sided|95.0|-22.062|-13.927||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623402|NCT02277769|2980736|Superiority||difference in percentages|23.3|||<|0.0001|2-Sided|95.0|16.63|30.05||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623403|NCT02277769|2980736|Superiority||difference in percentages|22.8|||<|0.0001|2-Sided|95.0|16.09|29.59||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623404|NCT02277769|2980737|Superiority||difference in percentages|39.1|||<|0.0001|2-Sided|95.0|30.92|47.19||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623405|NCT02277769|2980737|Superiority||difference in percentages|43.2|||<|0.0001|2-Sided|95.0|35.12|51.29||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623406|NCT02277769|2980738|Superiority||LS mean difference|-38.2|||<|0.0001|2-Sided|95.0|-45.55|-30.88||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623407|NCT02277769|2980738|Superiority||LS mean difference|-36.2|||<|0.0001|2-Sided|95.0|-43.46|-28.86|||ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623408|NCT02277769|2980739|Superiority||LS mean difference|-2.47|||<|0.0001|2-Sided|95.0|-2.982|-1.957||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623409|NCT02277769|2980739|Superiority||LS mean difference|-2.1|||<|0.0001|2-Sided|95.0|-2.605|-1.587||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623410|NCT02277769|2980740|Superiority||difference in percentages|11.8|||<|0.0001|2-Sided|95.0|7.31|16.32||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623411|NCT02277769|2980740|Superiority||difference in percentages|9.8|||<|0.0001|2-Sided|95.0|5.54|13.98||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623412|NCT02277769|2980741|Superiority||difference in percentages|21.3|||<|0.0001|2-Sided|95.0|14.66|27.93||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623413|NCT02277769|2980741|Superiority||difference in percentages|16.3|||<|0.0001|2-Sided|95.0|9.99|22.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623414|NCT02277769|2980742|Superiority||Least square (LS) mean difference|-32.8|||<|0.0001|2-Sided|95.0|-40.2|-25.49||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623415|NCT02277769|2980742|Superiority||LS mean difference|-28.9|||<|0.0001|2-Sided|95.0|-36.04|-21.83||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623727|NCT02271698|2981282|Superiority or Other|||||||0.394||||||36 hour pain with movement|t-test, 2 sided||||
1623416|NCT02277769|2980743|Superiority||difference in percentages|36.3|||<|0.0001|2-Sided|95.0|28.56|44.06||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623417|NCT02277769|2980743|Superiority||difference in percentages|37.8|||<|0.0001|2-Sided|95.0|30.03|45.6||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623418|NCT02277769|2980744|Superiority||difference in percentages|29.5|||<|0.0001|2-Sided|95.0|22.11|36.95||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623419|NCT02277769|2980744|Superiority||difference in percentages|26.5|||<|0.0001|2-Sided|95.0|19.13|33.87||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623420|NCT02277769|2980745|Superiority||difference in percentages|36.3|||<|0.0001|2-Sided|95.0|28.69|43.81||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.|
1623421|NCT02277769|2980745|Superiority||difference in percentages|32.3|||<|0.0001|2-Sided|95.0|24.75|39.94||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.|
1623422|NCT02277769|2980746|Superiority||difference in percentages|27.9|||<|0.0001|2-Sided|95.0|20.87|34.99||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.|
1623423|NCT02277769|2980746|Superiority||difference in percentages|27.6|||<|0.0001|2-Sided|95.0|20.46|34.69||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.|
1623424|NCT02277743|2980750|Superiority||LS mean difference|-15.1|||<|0.0001|2-Sided|95.0|-19.62|-10.5||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623425|NCT02277743|2980750|Superiority||LS mean difference|-16.5|||<|0.0001|2-Sided|95.0|-21.08|-11.9||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623426|NCT02277743|2980751|Superiority||LS mean difference|-25.6|||<|0.0001|2-Sided|95.0|-33.06|-18.12||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623427|NCT02277743|2980751|Superiority||LS mean difference|-27.0|||<|0.0001|2-Sided|95.0|-35.04|-18.91||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623428|NCT02277743|2980752|Superiority||LS mean difference|-2.2||||0.0003|2-Sided|95.0|-3.46|-1.03||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623429|NCT02277743|2980752|Superiority||LS mean difference|-2.2||||0.0006|2-Sided|95.0|-3.44|-0.95||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623430|NCT02277743|2980753|Superiority||LS mean difference|-5.9|||<|0.0001|2-Sided|95.0|-7.44|-4.32||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623431|NCT02277743|2980753|Superiority||LS mean difference|-6.5|||<|0.0001|2-Sided|95.0|-8.02|-5.01||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623432|NCT02277743|2980754|Superiority||LS mean difference|-3.7|||<|0.0001|2-Sided|95.0|-4.87|-2.49||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623433|NCT02277743|2980754|Superiority||LS mean difference|-4.0|||<|0.0001|2-Sided|95.0|-5.16|-2.8||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623434|NCT02277743|2980755|Superiority||LS mean difference|-28.0|||<|0.0001|2-Sided|95.0|-35.09|-20.87||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623435|NCT02277743|2980755|Superiority||LS mean difference|-28.7|||<|0.0001|2-Sided|95.0|-35.79|-21.54||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623728|NCT02271698|2981282|Superiority or Other|||||||0.457||||||36 hour pain at rest|t-test, 2 sided||||
1623436|NCT02277743|2980756|Superiority||LS mean difference|-18.89|||<|0.0001|2-Sided|95.0|-23.125|-14.65||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623437|NCT02277743|2980756|Superiority||LS mean difference|-17.92|||<|0.0001|2-Sided|95.0|-22.487|-13.353||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623438|NCT02277743|2980757|Superiority||difference in percentages|25.6|||<|0.0001|2-Sided|95.0|18.51|32.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623439|NCT02277743|2980757|Superiority||difference in percentages|28.1|||<|0.0001|2-Sided|95.0|20.96|35.29||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623440|NCT02277743|2980758|Superiority||difference in percentages|36.4|||<|0.0001|2-Sided|95.0|27.9|44.96||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623441|NCT02277743|2980758|Superiority||difference in percentages|44.2|||<|0.0001|2-Sided|95.0|35.91|52.48||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623442|NCT02277743|2980759|Superiority||LS mean difference|-34.4|||<|0.0001|2-Sided|95.0|-42.17|-26.56||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623443|NCT02277743|2980759|Superiority||LS mean difference|-34.6|||<|0.0001|2-Sided|95.0|-42.35|-26.88||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623444|NCT02277743|2980760|Superiority||LS mean difference|-1.69|||<|0.0001|2-Sided|95.0|-2.189|-1.186||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623445|NCT02277743|2980760|Superiority||LS mean difference|-1.75|||<|0.0001|2-Sided|95.0|-2.236|-1.26||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623446|NCT02277743|2980761|Superiority||difference in percentages|6.2||||0.0094|2-Sided|95.0|1.45|10.86||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623447|NCT02277743|2980761|Superiority||difference in percentages|6.1||||0.0097|2-Sided|95.0|1.49|10.68||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623448|NCT02277743|2980762|Superiority||difference in percentages|17.3|||<|0.0001|2-Sided|95.0|10.57|23.93||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623449|NCT02277743|2980762|Superiority||difference in percentages|9.8|||<|0.0012|2-Sided|95.0|3.95|15.71||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623450|NCT02277743|2980763|Superiority||LS mean difference|-22.8|||<|0.0001|2-Sided|95.0|-30.33|-15.33||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623451|NCT02277743|2980763|Superiority||Least square (LS) mean difference|-24.9|||<|0.0001|2-Sided|95.0|-32.26|-17.52||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623452|NCT02277743|2980764|Superiority||difference in percentages|34.5|||<|0.0001|2-Sided|95.0|26.08|42.84||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623453|NCT02277743|2980764|Superiority||difference in percentages|29.6|||<|0.0001|2-Sided|95.0|21.36|37.88||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous outcome measure was statistically significant).|
1623454|NCT02277743|2980765|Superiority||difference in percentages|28.0|||<|0.0001|2-Sided|95.0|19.94|36.13||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623455|NCT02277743|2980765|Superiority||difference in percentages|28.6|||<|0.0001|2-Sided|95.0|20.64|36.52||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1623486|NCT02276274|2980882|Superiority or Other||Least Squares Mean Difference|-0.1518|||||2-Sided|90.0|-0.2356|-0.068|||||ANOVA was performed on log-transformed values of Cmax with regimen, treatment group (treatment sequence), and treatment period as fixed effects.||
1623511|NCT02275117|2980999|Superiority|75% Migraine Responder Rate – Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|7.5||||0.2013|2-Sided|95.0|-3.5|18.5|||Cochran-Mantel-Haenszel||||
1623456|NCT02277743|2980766|Superiority||difference in percentages|37.7|||<|0.0001|2-Sided|95.0|29.7|45.77||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.|
1623457|NCT02277743|2980766|Superiority||difference in percentages|36.6|||<|0.0001|2-Sided|95.0|28.58|44.63||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level. Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.|
1623458|NCT02277743|2980767|Superiority||difference in percentages|27.0|||<|0.0001|2-Sided|95.0|19.47|34.44||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.|
1623459|NCT02277743|2980767|Superiority||difference in percentages|27.7|||<|0.0001|2-Sided|95.0|20.18|35.17||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w vs Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity.|
1623460|NCT02277691|2980768|Superiority or Other||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home DBP, morning at EOT (Up to Week 52).|
1623461|NCT02277691|2980768|Superiority or Other||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home DBP, morning at End of Week 12.|
1623462|NCT02277691|2980768|Superiority or Other||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home SBP, morning at EOT (Up to Week 52).|
1623463|NCT02277691|2980768|Superiority or Other||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in home SBP, morning at End of Week 12.|
1623464|NCT02277691|2980769|Superiority or Other||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough sitting DBP at Week 52 (LOCF).|
1623465|NCT02277691|2980769|Superiority or Other||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough sitting DBP at Week 12 (LOCF).|
1623466|NCT02277691|2980769|Superiority or Other||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough SBP at Week 52 (LOCF).|
1623467|NCT02277691|2980769|Superiority or Other||||||<|0.0001|||||||One sample t-test|||P-value has been estimated for change from baseline in office trough SBP at Week 12 (LOCF).|
1623468|NCT02277665|2980775|Superiority|||||||0.04|||||||Chi-squared||||
1623469|NCT02277665|2980776|Superiority|||||||0.46|||||||t-test, 2 sided||||
1623470|NCT02277665|2980777|Superiority||Means Ratio|0.97||||0.87|2-Sided|95.0|0.66|1.42|||Chi-squared||||
1623471|NCT02277665|2980778|Other||Odds Ratio (OR)|0.45|||=|0|2-Sided|95.0|0.15|1.35|||Chi-squared||||
1623472|NCT02277665|2980779|Other||Odds Ratio (OR)|0.32||||0.57|2-Sided||||||Chi-squared||||
1623473|NCT02277665|2980780|Superiority|Chi-square|Odds Ratio (OR)|0.56|||=|0|2-Sided|95.0|0.17|1.82|||Chi-squared||||
1623474|NCT02277249|2980788|Superiority or Other|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||No power calculation performed given that this was a pilot study. The null hypothesis was that there would be no difference in pain score with injection between the two study arms. The Wilcoxon rank sum test was selected because of the study's small sample size and the non-normal distribution of pain scores. Intention to treat analyses were used.|
1623475|NCT02276807|2980827|Superiority||Mean Difference (Final Values)|0.722|||<|0.05|2-Sided||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (Time: Baseline vs. Week 12) Repeated Measures ANOVA|||
1623476|NCT02276807|2980828|Superiority||Mean Difference (Final Values)|0.014|||<|0.05|2-Sided||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (Time: Baseline, Week 12) Repeated Measures ANOVA|||
1623477|NCT02276807|2980829|Superiority||Mean Difference (Final Values)|0.666|||<|0.05|2-Sided||||||ANOVA|2 (Condition: TAU, BA-PC) X 2 (Time: Baseline, Week 12) Repeated Measures ANOVA|||
1623478|NCT02276807|2980830|Superiority||Mean Difference (Final Values)|0.046|||<|0.05|2-Sided||||||ANOVA|2 (Condition: TAU vs. BA-PC) X 2 (time: Baseline vs. week 12) repeated measures ANOVA|||
1623479|NCT02276807|2980831|Superiority||Mean Difference (Final Values)|0.345|||<|0.05|2-Sided||||||ANOVA|2 (Condition: TAU, BA-PC) X 2 (Time: Baseline vs. Week 12) repeated measures ANOVA|||
1623480|NCT02276482|2980847|Other||Difference in percentages|0.0|||||2-Sided|95.0|0.0|0.0|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.||
1623481|NCT02276482|2980848|Other||Difference in percentages|0.2|||||2-Sided|95.0|-7.4|7.7|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.||
1623482|NCT02276482|2980849|Other||Difference in percentages|-4.2|||||2-Sided|95.0|-12.9|4.4|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.||
1623483|NCT02276482|2980850|Other||Difference in percentages|3.7|||||2-Sided|95.0|-3.4|10.8|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.||
1623484|NCT02276482|2980851|Other||Difference in percentages|3.6|||||2-Sided|95.0|-6.3|13.5|||||The difference (Tedizolid minus Comparator group) in the clinical success rate and 95% confidence interval calculated using the unstratified method of Miettinen and Nurminen.||
1623485|NCT02276274|2980880|Superiority or Other||Least Squares Mean Difference|-0.0179|||||2-Sided|90.0|-0.095|0.0591|||||ANOVA was performed on log-transformed values of AUC (0-inf) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.||
1623487|NCT02276274|2980884|Superiority or Other||Least Squares Mean Difference|-0.0164|||||2-Sided|90.0|-0.0934|0.0605|||||ANOVA was performed on log-transformed values of AUC (0-tlqc) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.||
1623488|NCT02276274|2980885|Superiority or Other||Least Squares Mean Difference|-0.014|||||2-Sided|90.0|-0.0918|0.0638|||||ANOVA was performed on log-transformed values of AUC (0-48) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.||
1623489|NCT02276274|2980900|Superiority or Other||Least Squares Mean Difference|-0.0139|||||2-Sided|90.0|-0.0598|0.032|||||ANOVA was performed on log-transformed values of AUC (0-inf) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.||
1623490|NCT02276274|2980902|Superiority or Other||Least Squares Mean Difference|0.1182|||||2-Sided|90.0|-0.0405|0.2769|||||ANOVA was performed on log-transformed values of Cmax with regimen, treatment group (treatment sequence), and treatment period as fixed effects.||
1623491|NCT02276274|2980903|Superiority or Other||Least Squares Mean Difference|-0.0164|||||2-Sided|90.0|-0.0592|0.0264|||||ANOVA was performed on log-transformed values of AUC (0-tlqc) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.||
1623492|NCT02276274|2980904|Superiority or Other||Least Squares Mean Difference|-0.0164|||||2-Sided|90.0|-0.0592|0.0264|||||Analysis of variance (ANOVA) was performed on log-transformed values of AUC (0-72) with regimen, treatment group (treatment sequence), and treatment period as fixed effects.||
1623493|NCT02276222|2980905|Superiority||Least Squares Mean (SE)|0.0084|Standard Error of the Mean|0.01012||0.4041|2-Sided|95.0|-0.0114|0.0283|||ANCOVA||||
1623494|NCT02276053|2980925|Other||Retention rate|86.0|||||2-Sided|95.0|79.0|93.1|||||"Confidence intervals for the 6-month retention rate were calculated using Greenwood's formula.~Addition of a note: Not all patients had an Observation Period of 6 months."|The retention rate was derived using Kaplan-Meier methodology where patients who completed the study were censored at the date of last administration of LCM in the study.|
1623495|NCT02275780|2980931|Other||Treatment Difference|7.606|||||2-Sided|95.0|0.98|14.232|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||
1623496|NCT02275780|2980932|Other||Treatment Difference|4.169|||||2-Sided|95.0|-1.404|9.743|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||
1623497|NCT02275780|2980941|Other||Treatment Difference (mg/dL)|-19.34|||<|0.0001|2-Sided|95.0|-23.33|-15.35|||ANCOVA|Terms for Baseline lipid level and treatment group|||
1623498|NCT02275780|2980942|Other||Treatment Difference (mg/dL)|-14.61|||<|0.0001|2-Sided|95.0|-18.15|-11.06|||ANCOVA|Terms for Baseline lipid level and treatment group|||
1623499|NCT02275780|2980943|Other||Mean treatment difference|17.4|||||2-Sided|95.0|-14.5|49.3|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||
1623500|NCT02275780|2980944|Other||Mean treatment difference|7.1|||||2-Sided|95.0|-20.8|35.0|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||
1623501|NCT02275780|2980945|Non-Inferiority|Doravirine is concluded to be non-inferior to darunavir + ritonavir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Treatment Difference|7.082|||||2-Sided|95.0|0.508|13.656|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||
1623502|NCT02275780|2980946|Non-Inferiority|Doravirine is concluded to be non-inferior to darunavir + ritonavir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Treatment Difference|3.913|||||2-Sided|95.0|-1.59|9.415|||||Stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum.||
1623503|NCT02275364|2980958|Superiority or Other||Adjusted Mean Difference|0.02||||0.4621|2-Sided|95.0|-0.03|0.07||Obtained from ANOVA with treatment, period and region of interest as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.||
1623504|NCT02275364|2980959|Superiority or Other||Adjusted Mean Difference|191.72||||0.1639|2-Sided|95.0|-78.62|462.06||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANCOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.||
1623505|NCT02275364|2980960|Superiority or Other||Adjusted Mean Difference|-0.46||||0.7278|2-Sided|95.0|-3.06|2.14||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.||
1623506|NCT02275364|2980961|Superiority or Other||Adjusted Mean Difference|1533.74||||0.0004|2-Sided|95.0|794.16|2273.32||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.||
1623507|NCT02275364|2980962|Superiority or Other||Adjusted Mean Difference|-0.93||||0.7366|2-Sided|95.0|-6.43|4.57||Obtained from ANOVA with treatment, period and region of interest as fixed effects and subject as a random effect.|ANCOVA||Adjusted Mean Difference is the Treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.||
1623508|NCT02275364|2980963|Superiority or Other||Adjusted Mean Difference|15.28|||<|0.0001|2-Sided|95.0|12.32|18.25||Obtained from ANOVA model with Treatment and Period as fixed effects and subject as a random effect.|ANOVA||Adjusted Mean Difference is the treatment difference defined as the Adjusted Mean of Test Nasal Strip minus Adjusted Mean of Placebo Strip.||
1623509|NCT02275338|2980972|Other|||||||0.0055||||||The expected proportion of responders using Lanreotide was 50%, 1 sided test, 2.5% significance level alpha and power of 80% using Z-test for binomial proportion.|Binomial test|||One sided binomial test to compare percentage of responding subjects to theoretical proportion of 30%.|
1623510|NCT02275117|2980999|Superiority|75% Migraine Responder Rate – Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|6.1||||0.2938|2-Sided|95.0|-4.6|16.9|||Cochran-Mantel-Haenszel||||
1623572|NCT02273323|2981111|Superiority or Other||Mean Difference (Final Values)|-0.4|||||2-Sided|95.0|-2.16|1.37|||||||
1623512|NCT02275117|2980999|Superiority|75% Migraine Responder Rate – Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|10.7||||0.0715|2-Sided|95.0|-0.5|21.8|||Cochran-Mantel-Haenszel||||
1623513|NCT02275117|2980999|Superiority|75% Migraine Responder Rate – Week 1-12 (Modified Full Analysis Population)|Mean Difference (Final Values)|12.6||||0.033|2-Sided|95.0|1.3|24.0|||Cochran-Mantel-Haenszel||||
1623514|NCT02275052|2981000|Superiority or Other||Least squares mean difference|0.259|||<|0.001|2-Sided|95.0|0.194|0.324|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.||
1623515|NCT02275052|2981001|Superiority or Other||Least squares mean difference|-0.346|||<|0.001|2-Sided|95.0|-0.487|-0.204|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.||
1623516|NCT02275052|2981002|Superiority or Other||Least squares mean difference|0.206|||<|0.001|2-Sided|95.0|0.167|0.246|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.||
1623517|NCT02275052|2981003|Superiority or Other||Least squares mean difference|3.31||||0.79|2-Sided|95.0|-21.12|27.74||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean change difference=UMEC/VI 62.5/25 µg minus Placebo.||
1623518|NCT02274857|2981020|Superiority|||||||0.3522|||||||Chi-squared||||
1623519|NCT02274857|2981021|Superiority|||||||0.7266|||||||Chi-squared||||
1623520|NCT02274857|2981022|Superiority|||||||0.2782|||||||Chi-squared||||
1623521|NCT02274857|2981023|Superiority|||||||0.2179|||||||Chi-squared||||
1623522|NCT02274766|2981029|Superiority||Least Squares Mean Difference|-1.1|Standard Error of the Mean|0.461||0.0199|2-Sided|95.0|-2.02|-0.18||Change from Baseline in OFF time.|Linear Mixed Model w/ Repeated Measures||||
1623523|NCT02274766|2981029|Superiority||Least Squares Mean Difference|-1.13|Standard Error of the Mean|0.648||0.0853|2-Sided|95.0|-2.42|0.16||Change from Baseline in ON time with troublesome dyskinesia.|Linear Mixed Model w/ Repeated Measures||||
1623524|NCT02274766|2981029|Superiority||Least Squares Mean Difference|1.9|Standard Error of the Mean|0.775||0.0168|2-Sided|95.0|0.35|3.45||Change from Baseline in ON time without troublesome dyskinesia.|Linear Mixed Model w/ Repeated Measures||||
1623525|NCT02274766|2981030|Superiority||Least Squares Mean Difference|-14.4|Standard Error of the Mean|3.03|<|0.0001|2-Sided|95.0|-20.4|-8.3|||Linear Mixed Model w/ Repeated Measures|Change from baseline is a dependent variable; the baseline value is a continuous covariate||32 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.|
1623526|NCT02274688|2981031|Superiority|||||||0.36|||||||Wald Chi-Square=3.24, df=3, p=0.36|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."|
1623527|NCT02274688|2981032|Superiority||||||=|0||||||F(3,507)=2.24, P=0.08|Regression Poisson|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."|
1623528|NCT02274688|2981033|Superiority||||||=|0|||||||Wald Chi-Square=4.44, df=3, p=0.22|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."|
1623529|NCT02274688|2981034|Superiority||||||=|0|||||||Wald Chi-Square=4.02, df=3, p=0.26|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."|
1623530|NCT02274688|2981035|Superiority||||||=|0|||||||Wald Chi-Square=3.52, df=3; p=0.32|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."|
1623531|NCT02274688|2981036|Superiority||||||=|0|||||||Wald Chi-Square=2.12, df=3, p=0.55|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."|
1623532|NCT02274688|2981037|Superiority||||||=|0|||||||Wald Chi-Square=4.25, df=3, p=0.23|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."|
1623533|NCT02274688|2981038|Superiority||||||=|0|||||||Wald Chi-Square=3.01, df=3, p=0.23|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."|
1623534|NCT02274688|2981039|Superiority||||||=|0|||||||Wald Chi-Square=11.29, df=3, P=0.01|||"Mixed Model Regression; Data from all 171 patients at all time points used in this intent-to-treat analytic approach.~We hypothesize intervention patients will demonstrate diminished outcome severity over time when compared to nurse notification patients, as evidenced by a significant group by time interaction effect."|
1623535|NCT02274558|2981054|Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1623536|NCT02274558|2981054|Other||||||<|0.02|||||||Cochran-Mantel-Haenszel||||
1623537|NCT02274558|2981055|Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.056|2-Sided|95.0|-0.5|0.0|||Mixed-effect Model Repeated Measures||||
1623573|NCT02273323|2981112|Superiority or Other||Mean Difference (Final Values)|-1.35|||||2-Sided|95.0|-5.26|2.55|||||||
1623538|NCT02274558|2981055|Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0742|2-Sided|95.0|-0.5|0.0|||Mixed-effect Model Repeated Measures||||
1623539|NCT02274558|2981056|Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|0.6||0.0021|2-Sided|95.0|-3.0|-0.7||Nominal P-value, not adjusted for multiplicity. See comments in above statistical analysis overview regarding the fixed-sequence testing procedure to control for multiplicity.|Mixed-effect Model Repeated Measures||||
1623540|NCT02274558|2981056|Other||Mean Difference (Final Values)|-3.1|Standard Error of the Mean|0.6|<|0.0001|2-Sided|95.0|-4.2|-2.0|||Mixed-effect Model Repeated Measures|||"Control for multiplicity was accomplished through the a fixed-sequence testing procedure for Week 6 outcomes:~AIMS dyskinesia total score mean change from baseline (CFB): valbenazine 80 mg vs. placebo.~CGI-TD mean score: VBZ 80 mg vs. PBO.~AIMS: VBZ 40 mg vs. PBO.~CGI-TD: VBZ 40 mg vs. PBO.~For a test result in the above list to be considered statistically significant, all of the test results higher in the list must have been significant at the 0.05 level of significance."|
1623541|NCT02274311|2981063|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||"Measures of central tendency (mean) and variability (range and/or SD) were used to describe numeric variables. Paired Student’s t test was used to verify the mean differences between dependent normally distributed variables. Wilcoxon sign test was performed to non-normally distributed dependent variables.~Asignificance level of 5%was adopted for all statistical tests (P <.05)."|
1623542|NCT02273973|2981067|Superiority||Least squares mean difference|-13.32||||0.002|2-Sided|95.0|-21.67|-4.96|||Regression, Linear||||
1623543|NCT02273973|2981069|Superiority||Ratio of Least square mean|1.25||||0.105|2-Sided|95.0|0.95|1.65|||Regression, Linear|||Statistical analysis for changes in Ki67 levels from Baseline to Surgery.|
1623544|NCT02273973|2981069|Superiority||Ratio of Least square mean|0.83||||0.117|2-Sided|95.0|0.65|1.05|||Regression, Linear|||Statistical analysis for changes in Ki67 levels from Baseline to Week 3.|
1623545|NCT02273973|2981070|Superiority||Difference in Response Rates|2.41||||0.787|2-Sided|95.0|-11.82|16.63|||Cochran-Mantel-Haenszel||||
1623546|NCT02273973|2981071|Superiority||Difference in Response Rates|10.68||||0.1554|2-Sided|95.0|-3.96|25.32|||Cochran-Mantel-Haenszel||||
1623547|NCT02273973|2981072|Superiority||Difference in Response Rates|7.63||||0.3299|2-Sided|95.0|-6.34|21.6|||Cochran-Mantel-Haenszel||||
1623548|NCT02273973|2981073|Superiority||Difference in Response Rates|9.45||||0.2659|2-Sided|95.0|-5.8|24.7|||Cochran-Mantel-Haenszel||||
1623549|NCT02273973|2981074|Superiority||Difference in Response Rates|2.66||||0.7928|2-Sided|95.0|-11.88|17.2|||Cochran-Mantel-Haenszel||||
1623550|NCT02273973|2981075|Superiority||Difference in Response Rates|21.14||||0.0115|2-Sided|95.0|5.59|36.68|||Cochran-Mantel-Haenszel||||
1623551|NCT02273973|2981076|Superiority||Difference in Response Rates|1.05||||1|2-Sided|95.0|-2.65|4.75|||Fisher Exact||||
1623552|NCT02273973|2981077|Superiority||Difference in Response Rates|5.2||||0.5017|2-Sided|95.0|-9.2|19.61|||Cochran-Mantel-Haenszel||||
1623553|NCT02273973|2981078|Superiority||Difference in Response Rates|1.37||||0.4803|2-Sided|95.0|-1.3|4.04|||Fisher Exact||||
1623554|NCT02273973|2981079|Superiority||Difference in Response Rates|18.19||||0.0332|2-Sided|95.0|2.57|33.81|||Cochran-Mantel-Haenszel||||
1623555|NCT02273973|2981080|Superiority||Difference in Response Rates|1.21||||0.3698|2-Sided|95.0|-1.12|3.55|||Fisher Exact||||
1623556|NCT02273973|2981081|Superiority||Difference in Response Rates|10.71||||0.049|2-Sided|95.0|0.11|21.32|||Cochran-Mantel-Haenszel||||
1623557|NCT02273908|2981093|Superiority or Other||||||<|0.001|||||||Modified Chi-squared||||
1623558|NCT02273908|2981094|Superiority or Other||||||<|0.001|||||||Modified Chi-squared||||
1623559|NCT02273908|2981095|Superiority or Other||Mean Difference (Final Values)|1.292||||0.477|2-Sided|95.0|-2.282|4.866|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.|
1623560|NCT02273908|2981095|Superiority or Other||Mean Difference (Final Values)|4.697||||0.026|2-Sided|95.0|0.552|8.842|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.|
1623561|NCT02273908|2981096|Superiority or Other||Mean Difference (Final Values)|0.0329||||0.017|2-Sided|95.0|0.0058|0.06|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.|
1623562|NCT02273908|2981096|Superiority or Other||Mean Difference (Final Values)|0.0204||||0.175|2-Sided|95.0|-0.0091|0.0499|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.|
1623563|NCT02273908|2981097|Superiority or Other||Mean Difference (Final Values)|-0.674||||0.004|2-Sided|95.0|-1.125|-0.223|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.|
1623564|NCT02273908|2981097|Superiority or Other||Least Squares Mean Difference|-0.83|||<|0.001|2-Sided|95.0|-1.301|-0.359|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.|
1623565|NCT02273908|2981098|Superiority or Other||Least square mean difference|2.729||||0.004|2-Sided|95.0|0.9047|4.5533|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.|
1623566|NCT02273908|2981098|Superiority or Other||Mean Difference (Final Values)|3.3018|||<|0.001|2-Sided|95.0|1.4903|5.1133|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.|
1623567|NCT02273908|2981099|Superiority or Other||Mean Difference (Final Values)|-1.887|||<|0.001|2-Sided|95.0|-2.704|-1.071|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 4.|
1623568|NCT02273908|2981099|Superiority or Other||Least Squares Mean Difference|-2.259|||<|0.001|2-Sided|95.0|-3.131|-1.387|||Mixed Models Analysis|||Analysis on the mean difference between two groups with the change from baseline at Week 8.|
1623569|NCT02273908|2981100|Superiority or Other||Least Squares Mean Difference|-0.949|||<|0.001|2-Sided|95.0|-1.459|-0.439|||Mixed Models Analysis||||
1623570|NCT02273323|2981109|Superiority or Other||Mean Difference (Final Values)|1.68|||||2-Sided|95.0|-0.73|4.09|||||||
1623571|NCT02273323|2981110|Superiority or Other||Mean Difference (Final Values)|-1.89|||||2-Sided|95.0|-4.65|0.87|||||||
1623574|NCT02273323|2981113|Superiority or Other||Mean Difference (Final Values)|0.71||||0.2|2-Sided|95.0|-0.4|1.82|||Mixed Models Analysis|Subject=random factor; treatment, on/off medication, period = fixed effects||Estimated effect of tea vs. placebo|
1623575|NCT02273323|2981114|Superiority or Other||Mean Difference (Final Values)|0.23||||0.43|2-Sided|0.23|-0.37|0.83|||Mixed Models Analysis|||Estimated effect of tea vs placebo|
1623576|NCT02273206|2981119|Superiority|||||||0.95|||||||Chi-squared|||Self-efficacy at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623577|NCT02273206|2981119|Superiority|||||||0.89|||||||Chi-squared|||Self-efficacy at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623578|NCT02273206|2981119|Superiority|||||||0.7|||||||Chi-squared|||Self-efficacy at baseline.Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623579|NCT02273206|2981120|Superiority|||||||0.77|||||||Chi-squared|||Medication Adherence at 12 Months. Coding of the measure was based on Morisky et al. (2008).|
1623580|NCT02273206|2981120|Superiority|||||||0.2|||||||Chi-squared|||Medication Adherence at 6 months. Coding of the measure was based on Morisky et al. (2008).|
1623581|NCT02273206|2981120|Superiority|||||||0.78|||||||Chi-squared|||Medication Adherence at baseline. Coding of the measure was based on Morisky et al. (2008).|
1623582|NCT02273206|2981121|Superiority|||||||0.98|||||||Chi-squared|||Ambulatory Care Experiences - Quality at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623583|NCT02273206|2981121|Superiority|||||||0.38|||||||Chi-squared|||Ambulatory Care Experiences - Quality at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623584|NCT02273206|2981121|Superiority|||||||0.47|||||||Chi-squared|||Ambulatory Care Experiences - Quality at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623585|NCT02273206|2981121|Superiority|||||||0.19|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623586|NCT02273206|2981121|Superiority|||||||0.34|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623587|NCT02273206|2981121|Superiority|||||||0.55|||||||Chi-squared|||Ambulatory Care Experiences - Care Coordination at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623588|NCT02273206|2981121|Superiority|||||||0.63|||||||Chi-squared|||Ambulatory Care Experiences - Access at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623589|NCT02273206|2981121|Superiority|||||||0.69|||||||Chi-squared|||Ambulatory Care Experiences - Access at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623590|NCT02273206|2981121|Superiority|||||||0.91|||||||Chi-squared|||Ambulatory Care Experiences - Access at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623591|NCT02273206|2981121|Superiority|||||||0.02|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at twelve months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623592|NCT02273206|2981121|Superiority|||||||0.51|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at six months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623593|NCT02273206|2981121|Superiority|||||||0.5|||||||Chi-squared|||Ambulatory Care Experiences - Shared Decision Making at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623594|NCT02273206|2981122|Superiority|||||||0.32|||||||Chi-squared|||Devaluation-Discrimination Scale score at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623595|NCT02273206|2981122|Superiority|||||||0.18|||||||Chi-squared|||Devaluation-Discrimination Scale Score at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623596|NCT02273206|2981123|Superiority|||||||0.56|||||||Chi-squared|||Satisfaction with decision to participate in Mental Health Care at 12 months. Recoding of the continuous measure was based on quartiles.|
1623597|NCT02273206|2981125|Superiority|||||||1|||||||Chi-squared|||Cervical Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623598|NCT02273206|2981125|Superiority|||||||0.11|||||||Chi-squared|||Cervical Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623599|NCT02273206|2981125|Superiority|||||||0.64|||||||Chi-squared|||Cervical Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623600|NCT02273206|2981125|Superiority|||||||0.77|||||||Chi-squared|||Breast Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623601|NCT02273206|2981125|Superiority|||||||0.71|||||||Chi-squared|||Breast Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623602|NCT02273206|2981125|Superiority|||||||0.91|||||||Chi-squared|||Breast Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623603|NCT02273206|2981125|Superiority|||||||0.79|||||||Chi-squared|||Colorectal Cancer Screening attitudes at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623604|NCT02273206|2981125|Superiority|||||||0.86|||||||Chi-squared|||Colorectal Cancer Screening attitudes at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623605|NCT02273206|2981125|Superiority|||||||0.74|||||||Chi-squared|||Colorectal Cancer Screening attitudes at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623606|NCT02273206|2981126|Superiority|||||||0.68|||||||Chi-squared|||Medical Outcomes Study Health Survey at 12 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623607|NCT02273206|2981126|Superiority|||||||0.68|||||||Chi-squared|||Medical Outcomes Study Health Survey at 6 months. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623608|NCT02273206|2981126|Superiority|||||||0.54|||||||Chi-squared|||Medical Outcomes Study Health Survey at baseline. Continuous summary score was converted into 4 categories using quartiles as cut-points.|
1623609|NCT02273206|2981127|Superiority|||||||0.27|||||||Chi-squared|||Generalized Anxiety Disorder scale score at 12 months. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., & Lowe, B. (2006).|
1623610|NCT02273206|2981127|Superiority|||||||0.08|||||||Chi-squared|||Generalized Anxiety Disorder scale score at 6 months. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., & Lowe, B. (2006).|
1623611|NCT02273206|2981127|Superiority|||||||0.95|||||||Chi-squared|||Generalized Anxiety Disorder scale at baseline. Coding of the measure was based on Spitzer, R.L., Kroenke, K., Williams, J.B., & Lowe, B. (2006).|
1623612|NCT02273206|2981128|Superiority|||||||0.36|||||||Chi-squared|||Physician Recommendation of Mental Health Care at 12 months.|
1623613|NCT02273206|2981128|Superiority|||||||0.83|||||||Chi-squared|||Physician Recommendation of Mental Health Care at 6 months.|
1623614|NCT02273206|2981128|Superiority|||||||0.87|||||||Chi-squared|||Physician Recommendation of Mental Health Care at baseline.|
1623615|NCT02273206|2981128|Superiority|||||||0.39|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at 12 months.|
1623616|NCT02273206|2981128|Superiority|||||||0.31|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at 6 months. .|
1623617|NCT02273206|2981128|Superiority|||||||0.34|||||||Chi-squared|||Physician Recommendation of Cervical Cancer Screening at baseline.|
1623618|NCT02273206|2981128|Superiority|||||||0.55|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at 12 months.|
1623619|NCT02273206|2981128|Superiority|||||||0.15|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at 6 months.|
1623620|NCT02273206|2981128|Superiority|||||||0.99|||||||Chi-squared|||Physician Recommendation of Breast Cancer Screening at baseline.|
1623621|NCT02273206|2981128|Superiority|||||||0.07|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at 12 months.|
1623622|NCT02273206|2981128|Superiority|||||||0.38|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at 6 months.|
1623623|NCT02273206|2981128|Superiority|||||||0.17|||||||Chi-squared|||Physician Recommendation of Colorectal Cancer Screening at baseline.|
1623624|NCT02273206|2981129|Superiority|||||||0.56|||||||Chi-squared|||Satisfaction with decision to participate in Mental Health Care at 12 months.|
1623625|NCT02273206|2981129|Superiority|||||||0.92|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at 12 months.|
1623626|NCT02273206|2981129|Superiority|||||||0.82|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at 6 months.|
1623627|NCT02273206|2981129|Superiority|||||||0.65|||||||Chi-squared|||Satisfaction with decision to participate in cervical cancer screening at baseline.|
1623628|NCT02273206|2981129|Superiority|||||||0.87|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at 12 months.|
1623629|NCT02273206|2981129|Superiority|||||||0.72|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at 6 months.|
1623630|NCT02273206|2981129|Superiority|||||||0.72|||||||Chi-squared|||Satisfaction with decision to participate in breast cancer screening at baseline.|
1623631|NCT02273206|2981129|Superiority|||||||0.69|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at 12 months.|
1623632|NCT02273206|2981129|Superiority|||||||0.17|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at 6 months.|
1623633|NCT02273206|2981129|Superiority|||||||0.2|||||||Chi-squared|||Satisfaction with decision to participate in colorectal cancer screening at baseline.|
1623634|NCT02273206|2981130|Superiority|||||||0.99|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at 12 months.|
1623635|NCT02273206|2981130|Superiority|||||||0.92|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at 6 months.|
1623636|NCT02273206|2981130|Superiority|||||||0.57|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Prescriptions at baseline.|
1623637|NCT02273206|2981130|Superiority|||||||0.98|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at 12 months.|
1623638|NCT02273206|2981130|Superiority|||||||0.23|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at 6 months.|
1623639|NCT02273206|2981130|Superiority|||||||0.85|||||||Chi-squared|||Mental Health Care Utilization - Mental Health Visits at baseline.|
1623640|NCT02273206|2981131|Superiority|||||||0.3568|||||||Chi-squared|p<0.05||Breast Cancer Screening Intervention Arm Difference at 12 Months|
1623641|NCT02273206|2981131|Superiority|||||||0.1706|||||||Chi-squared|p<0.05||Cervical Cancer Screening Intervention Arm Difference at 12 Months|
1623642|NCT02273206|2981131|Superiority|||||||0.4483|||||||Chi-squared|p<0.05||Colorectal Cancer Screening Intervention Arm Difference at 12 Months|
1623643|NCT02273206|2981132|Superiority|||||||0.23|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at 12 months.|
1623644|NCT02273206|2981132|Superiority|||||||0.6|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at Baseline.|
1623645|NCT02273206|2981133|Superiority|||||||0.86|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at 6 Months|
1623646|NCT02273206|2981133|Superiority|||||||0.6|||||||Chi-squared|||The Hopkins Symptom Checklist (SCL-20) at baseline.|
1623647|NCT02273206|2981134|Superiority|||||||0.39|||||||Two-sample t-test|p<0.05||PHQ9 Intervention Arm Difference between baseline and 12-month follow up|
1623648|NCT02273206|2981135|Superiority|Test the coefficient for intervention|Odds Ratio (OR)|0.876||||0.4432|2-Sided|95.0|0.625|1.228||Treatment Group(CCI vs PCM)|Regression, Logistic|p<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline cervical cancer up to date status, age, and income.||
1623953|NCT02263326|2981802|Other|||||||0.866|||||||Wilcoxon (Mann-Whitney)||||
1623649|NCT02273206|2981136|Superiority|Test the coefficient for intervention|Odds Ratio (OR)|1.031||||0.8501|2-Sided|95.0|0.753|1.41||Treatment Group (CCI vs PCM)|Regression, Logistic|p<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline breast cancer up to date status, age, and income||
1623650|NCT02273206|2981137|Superiority|Test the coefficient for intervention|Odds Ratio (OR)|1.346||||0.0677|2-Sided|95.0|0.979|1.851||Treatment Group (CCI vs PCM)|Regression, Logistic|p<0.05|In the logistic regression model, adjustments were made for PHQ9 at baseline, improvement of depression by one level, baseline colorectal cancer up to date status, age, and income.||
1623651|NCT02273206|2981138|Superiority|||||||0.3917|||||||Chi-squared|p<0.05||Cervical Cancer Screening Intervention Arm Difference|
1623652|NCT02273206|2981138|Superiority|||||||0.9795|||||||Chi-squared|p<0.05||Breast Cancer Screening Intervention Arm Difference|
1623653|NCT02273206|2981138|Superiority|||||||0.2562|||||||Chi-squared|p<0.05||Colorectal Cancer Screening Intervention Arm Difference|
1623654|NCT02273180|2981147|Non-Inferiority|Non-inferiority of SAR342434 over Humalog was demonstrated if upper bound of 2-sided 95% confidence interval(CI) of difference between SAR342434 & Humalog was <0.3%.Inverse non-inferiority of Humalog over SAR342434 was tested using hierarchical step-down testing procedure:if non-inferiority of SAR342434 over Humalog was demonstrated,then inverse non-inferiority of Humalog over SAR342434 was tested, demonstrated if lower bound of 2-sided 95%CI of difference between SAR342434 & Humalog was >-0.3%.|Least Square (LS) Mean Difference|0.06|Standard Error of the Mean|0.071|||2-Sided|95.0|-0.084|0.197|||||SAR342434 vs. Humalog|Analysis was performed using a MMRM approach with treatment groups, randomization strata, visits and treatment-by-visit interaction as fixed categorical effects, and baseline HbA1c value and baseline HbA1c value-by-visit interaction as continuous fixed covariates. An unstructured correlation matrix was used to model within-participant errors.|
1623655|NCT02273167|2981148|Non-Inferiority or Equivalence|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 1-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.|Difference in PDR|0.61||||0.478|2-Sided|95.0|-7.78|9.09|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.|
1623656|NCT02273167|2981148|Non-Inferiority or Equivalence|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the overall colon was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence intervals.|Difference in PDR|-0.49||||0.579|2-Sided|95.0|-8.85|8.0|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.|
1623657|NCT02273167|2981149|Non-Inferiority or Equivalence|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits. Non-inferiority of NER1006 1-Day to MOVIPREP was proven.|Difference in PDR|2.37||||0.268|2-Sided|95.0|-6.12|10.82||Superiority of NER1006 1-Day to MOVIPREP not demonstrated statistically.|Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.|
1623658|NCT02273167|2981149|Non-Inferiority or Equivalence|To accommodate the comparison of two NER1006 regimens, a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated. Difference in Polyp Detection Rate in the colon ascendens was calculated as NER1006 2-Day rate - MOVIPREP rate (10% margin) determined using exact Clopper-Pearson confidence limits.|Difference in PDR|7.1||||0.024|2-Sided|95.0|-1.41|15.47|||Fisher Exact|||If at least one of the primary endpoints were met, then key secondary endpoints were evaluated hierarchically in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of MOVIPREP. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.|
1623659|NCT02273167|2981150|Non-Inferiority or Equivalence|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|0.8||||0.455|2-Sided|95.0|-7.65|9.11||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate – MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.|
1623701|NCT02272413|2981223|Other||Risk Ratio (RR)|1.08|||||2-Sided|95.0|0.74|1.57||||||Proteinuria, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where ‘a’ was the number of patients with TEAEs selected for comparability within treatment group X, ‘a+b’ was the total number of patients in treatment group X, ‘c’ was the number of patients with TEAEs selected for comparability within treatment group Y and ‘c+d’ was the total number of patients in treatment group Y.|
1623660|NCT02273167|2981150|Non-Inferiority or Equivalence|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|-0.29||||0.569|2-Sided|95.0|-8.74|8.02||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate – MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.|
1623661|NCT02273167|2981151|Non-Inferiority or Equivalence|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.55||||0.106|2-Sided|95.0|-4.8|12.0||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 1-Day relative to MOVIPREP with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 1-Day rate – MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.|
1623662|NCT02273167|2981151|Non-Inferiority or Equivalence|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of MOVIPREP using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.55||||0.106|2-Sided|95.0|-4.8|12.0||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 2-Day relative to MOVIPREP with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 2-Day rate – MOVIPREP rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.|
1623663|NCT02273167|2981152|Non-Inferiority or Equivalence|The confidence limits (CLs) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in excellent plus good rate|18.74|||<|0.001|1-Sided|97.5|10.32|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|
1623664|NCT02273167|2981152|Non-Inferiority or Equivalence|Confidence limits (CL) were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in excellent plus good rate|16.56|||<|0.001|1-Sided|97.5|8.11|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|
1623665|NCT02273167|2981153|Non-Inferiority or Equivalence|The CLs were adjusted for multiple comparisons (2 alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CLs. Calculated using exact Clopper-Pearson confidences limits. To accommodate the comparison of two NER1006 regimens a hierarchical testing approach will be used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in success rate|1.59||||0.328|1-Sided|97.5|-6.91|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 1-Day to MOVIPREP (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 1-Day success rate - MOVIPREP success rate. A Hochberg procedure was used to control Type I error since there were two alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|
1623729|NCT02271698|2981282|Superiority or Other|||||||0.228||||||24 hour pain with movement|t-test, 2 sided||||
1623730|NCT02271698|2981282|Superiority or Other|||||||0.806|||||||t-test, 2 sided|24 hour pain at rest|||
1623731|NCT02271698|2981282|Superiority or Other|||||||0.198||||||18 hour pain with movement|t-test, 2 sided||||
1623666|NCT02273167|2981153|Non-Inferiority or Equivalence|The confidence limits (CL) were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favour of MOVIPREP using lower 1-sided 97.5% CL. Calculated using exact Clopper-Pearson CLs. To accommodate the comparison of 2 NER1006 regimens a hierarchical testing approach was used whereby NER1006 2-Day was assessed first and, if successful, then NER1006 1-Day was evaluated.|Difference in success rate|4.5||||0.055|1-Sided|97.5|-4.0|||The p-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate non-inferiority (NI) of NER1006 2-Day to MOVIPREP (10% margin). Success rate was no. of patients with successful overall bowel cleansing as proportion of no. of patients in each group. Treatment effect was NER1006 2-Day success rate - MOVIPREP success rate. Hochberg procedure used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|
1623667|NCT02273141|2981154|Non-Inferiority or Equivalence|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in PDR|2.95||||0.278|2-Sided|95.0|-5.96|11.51||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate – SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.|
1623668|NCT02273141|2981155|Non-Inferiority or Equivalence|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in PDR|4.43||||0.064|2-Sided|95.0|-4.36|13.1||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate – SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.|
1623669|NCT02273141|2981156|Non-Inferiority or Equivalence|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|3.27||||0.212|2-Sided|95.0|-5.56|11.91||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate – SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.|
1623670|NCT02273141|2981157|Non-Inferiority or Equivalence|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|2.42||||0.154|2-Sided|95.0|-6.35|11.12||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to SP+MS with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate – SP+MS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.|
1623671|NCT02273141|2981158|Non-Inferiority or Equivalence|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in excellent plus good rate|3.2||||0.027|1-Sided|97.5|-5.56|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||Hypothesis was to demonstrate NI of NER1006 regimen to SP+MS (10% margin). Success rate was no. of patients with highly effective cleansing of the colon ascendens as proportion of no. of patients in each group. Treatment effect was NER1006 success rate – SP+MS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|
1623702|NCT02272413|2981223|Other||Risk Ratio (RR)|0.96|||||2-Sided|95.0|0.66|1.39||||||Hypertension, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where ‘a’ was the number of patients with TEAEs selected for comparability within treatment group X, ‘a+b’ was the total number of patients in treatment group X, ‘c’ was the number of patients with TEAEs selected for comparability within treatment group Y and ‘c+d’ was the total number of patients in treatment group Y.|
1623732|NCT02271698|2981282|Superiority or Other|||||||0.021||||||18 hour pain at rest|t-test, 2 sided||||
1623733|NCT02271698|2981282|Superiority or Other|||||||0.35||||||12 hour pain at rest|t-test, 2 sided||||
1623734|NCT02271698|2981282|Superiority or Other|||||||0.139|||||||t-test, 2 sided|12 hour pain at rest|||
1623672|NCT02273141|2981159|Non-Inferiority or Equivalence|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favor of SP+MS using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in success rate|8.22||||0.038|1-Sided|97.5|-0.5|||The p-value was adjusted for multiple comparisons (2 alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate non-inferiority (NI) of NER1006 regimen to SP+MS (10% margin). Success rate was no. of patients with successful overall bowel cleansing as proportion of no. of patients in each group. Treatment effect was NER1006 success rate – SP+MS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|
1623673|NCT02273050|2981171|Superiority or Other||Mean Difference (Net)|0.0|||>|0.999|2-Sided|95.0|-2.3|2.3|||Fisher Exact||||
1623674|NCT02273050|2981171|Superiority or Other||Mean Difference (Net)|-8.9|||<|0.001|2-Sided|95.0|-13.3|-4.5|||Fisher Exact||||
1623675|NCT02273050|2981172|Superiority or Other||Mean Difference (Net)|-1.14|Standard Error of the Mean|0.374||0.002|2-Sided|95.0|-1.88|-0.41|||ANCOVA||||
1623676|NCT02273050|2981172|Superiority or Other||Mean Difference (Net)|-2.97|Standard Error of the Mean|0.37|<|0.001|2-Sided|95.0|-3.7|-2.25|||ANCOVA||||
1623677|NCT02273050|2981173|Superiority or Other||Mean Difference (Net)|11.6||||0.02|2-Sided|95.0|2.3|20.9|||Fisher Exact||||
1623678|NCT02273050|2981173|Superiority or Other||Mean Difference (Net)|34.9|||<|0.001|2-Sided|95.0|26.0|43.9|||Fisher Exact||||
1623679|NCT02273050|2981174|Superiority or Other||Mean Difference (Net)|-169.3|Standard Error of the Mean|52.05||0.001|2-Sided|95.0|-271.7|-66.9|||ANCOVA||||
1623680|NCT02273050|2981174|Superiority or Other||Mean Difference (Net)|-416.0|Standard Error of the Mean|51.54|<|0.001|2-Sided|95.0|-517.3|-314.6|||ANCOVA||||
1623681|NCT02273050|2981175|Superiority or Other||Mean Difference (Net)|-0.32|Standard Error of the Mean|0.159||0.046|2-Sided|95.0|-0.63|0.0|||ANCOVA||||
1623682|NCT02273050|2981175|Superiority or Other||Mean Difference (Net)|-1.39|Standard Error of the Mean|0.158|<|0.001|2-Sided|95.0|-1.7|-1.08|||ANCOVA||||
1623683|NCT02273050|2981176|Superiority or Other||Mean Difference (Net)|10.7||||0.011|2-Sided|95.0|2.6|18.9|||Fisher Exact||||
1623684|NCT02273050|2981176|Superiority or Other||Mean Difference (Net)|37.5|||<|0.001|2-Sided|95.0|29.0|46.0|||Fisher Exact||||
1623685|NCT02273050|2981177|Superiority or Other||Mean Difference (Net)|-0.213|Standard Error of the Mean|0.1005||0.034|2-Sided|95.0|-0.41|-0.016|||ANCOVA||||
1623686|NCT02273050|2981177|Superiority or Other||Mean Difference (Net)|-0.885|Standard Error of the Mean|0.0994|<|0.001|2-Sided|95.0|-1.08|-0.689|||ANCOVA||||
1623687|NCT02272985|2981182|Other|||||||0.08|||||||Mixed Models Analysis|||Right frontal gray matter:|
1623688|NCT02272985|2981182|Other|||||||0.001|||||||Mixed Models Analysis|||Left frontal gray matter:|
1623689|NCT02272985|2981183|Other||||||=|0||||||the p value was calculated|Mixed Models Analysis||||
1623690|NCT02272816|2981184|Other||Percentage|100.0|||||2-Sided|95.0|92.6|100.0|||||||
1623691|NCT02272816|2981185|Other||Percentage|45.0|||||2-Sided|95.0|30.2|59.9|||||||
1623692|NCT02272816|2981186|Other||Percentage|95.6|||||1-Sided|95.0||98.6|||||||
1623693|NCT02272803|2981188|Superiority||Hazard Ratio (HR)|0.83|||||2-Sided|95.0|0.25|2.71|||||Hazard Ratio of E-Ld to Ld. Stratified by stage of disease (International Staging System 1 - 2 vs 3)||
1623694|NCT02272803|2981189|Other||Difference in Objective Response Rate|13.0|||||2-Sided|95.0|-3.5|29.6|||||Difference of E-Ld minus Ld. Computed using the method of DerSimonian and Laird (weighted average over the strata as recorded in randomization file).||
1623695|NCT02272413|2981220|Other||Hazard Ratio (HR)|1.14|||||2-Sided|95.0|0.88|1.48||||||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).|
1623696|NCT02272413|2981221|Other||Hazard Ratio (HR)|1.23|||||2-Sided|95.0|1.0|1.51||||||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).|
1623697|NCT02272413|2981222|Other||Hazard Ratio (HR)|1.22|||||2-Sided|95.0|1.02|1.45||||||Analysis based on a Cox-proportional hazards regression model. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus non East Asian).|
1623698|NCT02272413|2981223|Other||Risk Ratio (RR)|1.26|||||2-Sided|95.0|0.47|3.57||||||Wound healing complications/ abscesses/ fistulas, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where ‘a’ was the number of patients with TEAEs selected for comparability within treatment group X, ‘a+b’ was the total number of patients in treatment group X, ‘c’ was the number of patients with TEAEs selected for comparability within treatment group Y and ‘c+d’ was the total number of patients in treatment group Y.|
1623699|NCT02272413|2981223|Other||Risk Ratio (RR)|1.24|||||2-Sided|95.0|0.88|1.74||||||Other hemorrhages, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where ‘a’ was the number of patients with TEAEs selected for comparability within treatment group X, ‘a+b’ was the total number of patients in treatment group X, ‘c’ was the number of patients with TEAEs selected for comparability within treatment group Y and ‘c+d’ was the total number of patients in treatment group Y.|
1623700|NCT02272413|2981223|Other||Risk Ratio (RR)|1.31|||||2-Sided|95.0|0.28|10.79||||||Pulmonary haemorrhage, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where ‘a’ was the number of patients with TEAEs selected for comparability within treatment group X, ‘a+b’ was the total number of patients in treatment group X, ‘c’ was the number of patients with TEAEs selected for comparability within treatment group Y and ‘c+d’ was the total number of patients in treatment group Y.|
1623703|NCT02272413|2981223|Other||Risk Ratio (RR)|3.43|||||2-Sided|95.0|0.79|32.82||||||Gastrointestinal perforations, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where ‘a’ was the number of patients with TEAEs selected for comparability within treatment group X, ‘a+b’ was the total number of patients in treatment group X, ‘c’ was the number of patients with TEAEs selected for comparability within treatment group Y and ‘c+d’ was the total number of patients in treatment group Y.|
1623704|NCT02272413|2981223|Other||Risk Ratio (RR)|1.16|||||2-Sided|95.0|0.51|2.76||||||Febrile neutropenia, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where ‘a’ was the number of patients with TEAEs selected for comparability within treatment group X, ‘a+b’ was the total number of patients in treatment group X, ‘c’ was the number of patients with TEAEs selected for comparability within treatment group Y and ‘c+d’ was the total number of patients in treatment group Y.|
1623705|NCT02272413|2981223|Other||Risk Ratio|1.2|||||2-Sided|95.0|0.64|2.32||||||Thromboembolic events, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where ‘a’ was the number of patients with TEAEs selected for comparability within treatment group X, ‘a+b’ was the total number of patients in treatment group X, ‘c’ was the number of patients with TEAEs selected for comparability within treatment group Y and ‘c+d’ was the total number of patients in treatment group Y.|
1623706|NCT02272413|2981223|Other||Risk Ratio (RR)|1.28|||||2-Sided|95.0|0.88|1.88||||||Infusion reactions, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where ‘a’ was the number of patients with TEAEs selected for comparability within treatment group X, ‘a+b’ was the total number of patients in treatment group X, ‘c’ was the number of patients with TEAEs selected for comparability within treatment group Y and ‘c+d’ was the total number of patients in treatment group Y.|
1623707|NCT02272413|2981223|Other||Risk Ratio (RR)|1.16|||||2-Sided|95.0|0.99|1.37||||||At least 1 AE selected for comparability assessment, risk ratio X (BI 695502) versus Y (US-licensed Avastin®) was defined as (a/(a+b))/(c/(c+d)), where ‘a’ was the number of patients with TEAEs selected for comparability within treatment group X, ‘a+b’ was the total number of patients in treatment group X, ‘c’ was the number of patients with TEAEs selected for comparability within treatment group Y and ‘c+d’ was the total number of patients in treatment group Y.|
1623708|NCT02272413|2981224|Equivalence|Additional analysis of the primary endpoint was performed for Japan according to a local protocol amendment Japan. For the submission in Japan, to conclude on equivalence, the 2-sided 95% CI for the ratio of best ORR between the treatments had to be entirely contained within the equivalence margins of 0.736 to 1.359.|Ratio of best ORR|0.855|||||2-Sided|95.0|0.7543|0.97||||||Analysis was based on a log-binomial regression model with subsequent transformation of the estimated parameter (ratio of best ORR) respective CIs to the ratio scale. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus Non-East Asian).|
1623709|NCT02272413|2981224|Equivalence|The null hypothesis was to be rejected in favor of equivalence if the 2-sided 90% confidence interval (CI) for the ratio in best ORR between the treatments was entirely contained within the equivalence margins of 0.736 to 1.359.|Ratio of best ORR|0.855|||||2-Sided|90.0|0.7697|0.9506||||||Analysis was based on a log-binomial regression model with subsequent transformation of the estimated parameter (ratio of best ORR) respective CIs to the ratio scale. The model included the following explanatory variables: treatment, sex (male versus female), smoking status (never smoked versus current/ex-smoker), NSCLC stage (recurrent versus Stage IV) and ethnicity (East Asian origin versus Non-East Asian).|
1623710|NCT02272244|2981225|Superiority||Mean Difference (Final Values)|0.04||||0.88|2-Sided|95.0|-0.47|0.55|||Regression, Linear|Model of knowledge test score adjusts for all baseline covariates|Model compares DSNI to SI.||
1623711|NCT02272244|2981225|Superiority||Mean Difference (Final Values)|-0.01||||0.862|2-Sided|95.0|-0.15|0.13|||Regression, Linear|Model of difference in Preventive Health Model (PHM) total score adjusts for all baseline covariates.|Model compares DSNI to SI.||
1623712|NCT02272244|2981226|Superiority|Colonscopy vs None|Odds Ratio (OR)|8.79||||0.001|2-Sided|95.0|4.13|18.74|||Odds Ratio (OR)||||
1623713|NCT02272244|2981226|Superiority||Odds Ratio (OR)|4.2||||0.001|2-Sided|95.0|2.63|6.7|||Odds Ratio (OR)|Stool Blood Test vs None|||
1623714|NCT02272244|2981226|Superiority||||||<|0.001|||||||Regression, Multinomial|Model compared rates of SBT, CX and none; model is adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage|||Reference for the outcome is No Screening; reference for the study group is the Standard Intervention group.
1623715|NCT02272244|2981227|Superiority||Odds Ratio (OR)|4.91|||<|0.001|2-Sided|95.0|2.55|9.47|||Regression, Logistic|Model compares Forward Change to No Change or Backwards Change and is adjusted for all baseline covariates.|||
1623716|NCT02272244|2981228|Superiority||Odds Ratio (OR)|4.83|||<|0.001|2-Sided|95.0|3.08|7.58|||Regression, Logistic|Model adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage|||
1623717|NCT02271984|2981242|Superiority or Other||Ratio (%)|115.7|||||2-Sided|90.0|99.8|134.1|||||Percentage of Geometric LS Mean Ratio (Treatment E/Treatment A) is reported.||
1623718|NCT02271984|2981242|Superiority or Other||Ratio (%)|167.1|||||2-Sided|90.0|143.9|194.0|||||Percentage of Geometric LS Mean Ratio (Treatment A/Treatment D) is reported.||
1623719|NCT02271984|2981242|Superiority or Other||Ratio (%)|260.2|||||2-Sided|90.0|214.0|316.4|||||Percentage of Geometric LS Mean Ratio (Treatment C2/Treatment A) is reported.||
1623720|NCT02271984|2981242|Superiority or Other||Ratio (%)|27.3|||||2-Sided|90.0|22.5|33.2|||||Percentage of Geometric LS Mean Ratio (Treatment C1/Treatment A) is reported.||
1623721|NCT02271984|2981242|Superiority or Other||Ratio (%)|39.9|||||2-Sided|90.0|34.7|46.0|||||Percentage of Geometric Least Squares (LS) Mean Ratio (Treatment A/Treatment B) is reported.||
1623722|NCT02271698|2981281|Superiority or Other|||||||0.6||||||36 hours|t-test, 2 sided||||
1623723|NCT02271698|2981281|Superiority or Other|||||||0.733|||||||t-test, 2 sided|24 hours|||
1623724|NCT02271698|2981281|Superiority or Other|||||||0.605|||||||t-test, 2 sided|18 hours|||
1623725|NCT02271698|2981281|Superiority or Other|||||||0.364||||||12 hours|t-test, 2 sided||||
1623726|NCT02271698|2981281|Superiority or Other|||||||0.181||||||6 hours|t-test, 2 sided||||
1623735|NCT02271698|2981282|Superiority or Other|||||||0.064||||||6 hour pain with movement|t-test, 2 sided||||
1623736|NCT02271698|2981282|Superiority or Other|||||||0.052||||||6 hour pain at rest|t-test, 2 sided||||
1623737|NCT02271529|2981283|Non-Inferiority or Equivalence|Under the assumption that the mean percent change in stent length upon deployment being 0.2% with a standard deviation of 4%, type I error of 0.05, and two one-sided t-tests, a sample size of at least 30 stents provides power > 0.90 to determine that the mean length change of stents deployed with the thumbwheel delivery system is within +/-10%.|Mean percent change|-1.0|||<|0.01|2-Sided|95.0|-1.5|-0.4|||two one-sided t-tests||||
1623738|NCT02270983|2981320|Superiority||Least squares mean difference|-0.607|Standard Error of the Mean|0.205||0.0034|2-Sided|95.0|-1.011|-0.203|||ANCOVA||||
1623739|NCT02270983|2981320|Superiority||Least squares mean difference|0.033|Standard Error of the Mean|0.205||0.872|2-Sided|95.0|-0.371|0.437|||ANCOVA||||
1623740|NCT02270983|2981321|Superiority||Least squares mean difference|-0.669|Standard Error of the Mean|0.146|<|0.0001|2-Sided|95.0|-0.957|-0.382|||ANCOVA||||
1623741|NCT02270983|2981321|Superiority||Least squares mean difference|-0.46|Standard Error of the Mean|0.145|<|0.0017|2-Sided|95.0|-0.746|-0.174|||ANCOVA||||
1623742|NCT02270983|2981322|Superiority||Least squares mean difference|0.987|Standard Error of the Mean|0.217|<|0.0001|2-Sided|95.0|0.558|1.416|||ANCOVA||||
1623743|NCT02270983|2981322|Superiority||Least squares mean difference|0.751|Standard Error of the Mean|0.217|<|0.0007|2-Sided|95.0|0.324|1.178|||ANCOVA||||
1623744|NCT02270983|2981323|Superiority||Odds Ratio (OR)|1.92||||0.0506|2-Sided|95.0|1.0|3.68|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel tests comparing specified treatment groups, controlling for geographic region.|||
1623745|NCT02270983|2981323|Superiority||Odds Ratio (OR)|1.37||||0.3332|2-Sided|95.0|0.73|2.58|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel tests comparing specified treatment groups, controlling for geographic region.|||
1623746|NCT02270983|2981324|Superiority||Cox Proportional Hazard|1.43||||0.0287|2-Sided|95.0|1.04|1.97|||Log Rank||||
1623747|NCT02270983|2981324|Superiority||Cox Proportional Hazard|1.28||||0.1429|2-Sided|95.0|0.92|1.77|||Log Rank||||
1623748|NCT02270983|2981325|Superiority||Least squares mean difference|1.908|Standard Error of the Mean|0.451|<|0.0001|2-Sided|95.0|1.021|2.796|||ANCOVA||||
1623749|NCT02270983|2981325|Superiority||Least squares mean difference|1.325|Standard Error of the Mean|0.45|<|0.0035|2-Sided|95.0|0.439|2.211|||ANCOVA||||
1623750|NCT02270944|2981329|Non-Inferiority|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be > 0.5 and the upper limit of the two-sided 95% CI must be < 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|0.94|||||2-Sided|95.0|0.72|1.22||||||to demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ib when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).|
1623751|NCT02270944|2981330|Non-Inferiority|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be > 0.5 and the upper limit of the two-sided 95% CI must be < 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|0.99|||||2-Sided|95.0|0.76|1.3||||||to demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes III when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).|
1623752|NCT02270944|2981331|Non-Inferiority or Equivalence (legacy)|To assess the vaccine formulations equivalence, the lower limit of the two-sided 95% confidence interval (CI) for the ratio of GMCs at Day 31 after vaccination must be > 0.5 and the upper limit of the two-sided 95% CI must be < 2.0 (the entire two-sided 95% CI must be contained in the 0.5, 2.0 interval).|Ratio of GMCs|1.02|||||2-Sided|95.0|0.79|1.32||||||To demonstrate the equivalence of the liquid GBS trivalent vaccine formulation to the lyophilized GBS trivalent vaccine formulation for serotypes Ia when administered to healthy non-pregnant women, as measured by geometric mean concentrations (GMC).|
1623753|NCT02270671|2981333|Superiority or Other||||||>|0.05||||||Group x Time interaction p-value: >.05; Gender p-value: =.007|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p < .025.|||
1623754|NCT02270671|2981334|Superiority or Other||||||>|0.05||||||Group x Time interaction p-value: >.05; Gender p-value: <.0001|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p < .025.|||
1623755|NCT02270671|2981335|Superiority or Other||||||>|0.05||||||Group x Time interaction p-value: >.05; Gender p-value: >.05|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p < .025.|||
1623756|NCT02270671|2981336|Superiority or Other||||||>|0.05||||||Group x Time interaction p-value: >.05; Gender p-value: =.026|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p < .025.|||
1623757|NCT02270671|2981337|Superiority or Other||||||>|0.05||||||Group x Time interaction p-value: >.05; Gender p-value: >.05|ANOVA|2x2x3 repeated measures ANOVA. 2 between-subjects factors (Group; Gender) and 1 within-subject factor (Time). P value adjusted to p < .025.|||
1623758|NCT02270515|2981340|Superiority or Other|||||||0.02||||||This is the Effects KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623795|NCT02269917|2981380|Other||LS Mean Difference|-0.92|Standard Error of the Mean|0.624|=|0|2-Sided|95.0|-2.14|0.31|||ANCOVA|||Change at Week 24|
1623796|NCT02269917|2981381|Other||LS Mean Difference|-0.74|Standard Error of the Mean|0.862|=|0|2-Sided|95.0|-2.43|0.95|||ANCOVA|||Change Week 48|
1623797|NCT02269917|2981381|Other||LS Mean Difference|-0.58|Standard Error of the Mean|0.874|=|0|2-Sided|95.0|-2.3|1.13|||ANCOVA|||Change at Week 24|
1623759|NCT02270515|2981340|Superiority or Other|||||||0.61||||||This is the Symptoms KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623760|NCT02270515|2981340|Superiority or Other|||||||0.08||||||This is the Burden KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623761|NCT02270515|2981340|Superiority or Other|||||||0.01||||||This is the MCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623762|NCT02270515|2981340|Superiority or Other|||||||0.29||||||This is the PCS KDQOL Subscale p-value for change in 0-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623763|NCT02270515|2981340|Superiority or Other|||||||0.12||||||This is the Effects KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623764|NCT02270515|2981340|Superiority or Other|||||||0.03||||||This is the Symptoms KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623765|NCT02270515|2981340|Superiority or Other|||||||0.77||||||This is the Burden KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623766|NCT02270515|2981340|Superiority or Other|||||||0.79||||||This is the MCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623767|NCT02270515|2981340|Superiority or Other|||||||0.45||||||This is the PCS KDQOL Subscale p-value for change in 12-18 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623768|NCT02270515|2981340|Superiority or Other|||||||0.14||||||This is the Effects KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623769|NCT02270515|2981340|Superiority or Other|||||||0.77||||||This is the Symptoms KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623798|NCT02269917|2981382|Other||Least Square (LS) Mean Difference|0.62|Standard Error of the Mean|0.646|=|0|2-Sided|95.0|-0.65|1.88|||ANCOVA|||Change at Week 48|
1623799|NCT02269917|2981382|Other||Least Square (LS) Mean Difference|0.34|Standard Error of the Mean|0.623|=|0|2-Sided|95.0|-0.88|1.57|||ANCOVA|||Change at Week 24|
1623923|NCT02265705|2981727|Superiority||Difference in response rate|1.4|||||2-Sided|95.0|-0.5|3.3|||||||
1623770|NCT02270515|2981340|Superiority or Other|||||||0.77||||||This is the Burden KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623771|NCT02270515|2981340|Superiority or Other|||||||0.21||||||This is the MCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623772|NCT02270515|2981340|Superiority or Other|||||||0.01||||||This is the PCS KDQOL Subscale p-value for change in 6-12 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623773|NCT02270515|2981340|Superiority or Other|||||||0.004||||||This is the Effects KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Effects:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623774|NCT02270515|2981340|Superiority or Other|||||||0.02||||||This is the Symptoms KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Symptoms:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623775|NCT02270515|2981340|Superiority or Other|||||||0.18||||||This is the Burden KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"Burden:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623776|NCT02270515|2981340|Superiority or Other|||||||0.23||||||This is the MCS KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"MCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623777|NCT02270515|2981340|Superiority or Other|||||||0.002||||||This is the PCS KDQOL Subscale p-value for change in 0-6 months shown in Primary Outcome table 3.|Mixed Models Analysis|||"PCS:~From random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|
1623778|NCT02269917|2981365|Other||LS Mean Difference|1.7|Standard Error of the Mean|0.28|<|0.001|2-Sided|95.0|1.144|2.248|||ANCOVA|||Hip BMD: Percent change at Week 48|
1623779|NCT02269917|2981365|Other||LS Mean Difference|0.9|Standard Error of the Mean|0.272|=|0|2-Sided|95.0|0.366|1.436|||ANCOVA|||Hip BMD: Percent change at Week 24|
1623780|NCT02269917|2981365|Other||LS Mean Difference|2.05|Standard Error of the Mean|0.39|<|0.001|2-Sided|95.0|1.277|2.814|||ANCOVA|||Spine BMD: Percent change at Week 48|
1623781|NCT02269917|2981365|Other||LS Mean Difference|1.37|Standard Error of the Mean|0.34|<|0.001|2-Sided|95.0|0.697|2.037|||ANCOVA|||Spine BMD: Percent change at Week 24|
1623782|NCT02269917|2981376|Other||||||=|0|||||||Van Elteren Test|||FEPO4 - Change at Week 48|
1623783|NCT02269917|2981376|Other||||||=|0|||||||Van Elteren Test|||FEPO4 - Change at Week 24|
1623784|NCT02269917|2981377|Other||||||<|0.001|||||||Van Elteren Test|||UB2MGCR: Change at Week 48|
1623785|NCT02269917|2981377|Other||||||<|0.001|||||||Van Elteren Test|||UB2MGCR: Change at Week 24|
1623786|NCT02269917|2981377|Other||||||<|0.001|||||||Van Elteren Test|||URBPCR: Change at Week 48|
1623787|NCT02269917|2981377|Other||||||<|0.001|||||||Van Elteren Test|||URBPCR: Change at Week 24|
1623788|NCT02269917|2981378|Other||||||<|0.001|||||||Van Elteren Test|||UPCR - Change at Week 48|
1623789|NCT02269917|2981378|Other||||||<|0.001|||||||Van Elteren Test|||UPCR - Change at Week 24|
1623790|NCT02269917|2981378|Other||||||<|0.001|||||||Van Elteren Test|||UACR - Change at Week 48|
1623791|NCT02269917|2981378|Other||||||<|0.001|||||||Van Elteren Test|||UACR - Change at Week 24|
1623792|NCT02269917|2981379|Other||LS Mean Difference|1.34|Standard Error of the Mean|0.63|=|0|2-Sided|95.0|0.1|2.57|||ANCOVA|||Change at Week 48|
1623793|NCT02269917|2981379|Other||LS Mean Difference|1.14|Standard Error of the Mean|0.59|=|0|2-Sided|95.0|-0.02|2.29|||ANCOVA|||Change at Week 24|
1623794|NCT02269917|2981380|Other||LS Mean Difference|-1.09|Standard Error of the Mean|0.646|=|0|2-Sided|95.0|-2.36|0.18|||ANCOVA|||Change at Week 48|
1623800|NCT02269917|2981387|Non-Inferiority|4|Difference in percentage|0.4|||<|0.001|2-Sided|95.0|-1.5|2.2|||Stratum-adjusted Mantel-Haenszel (MH)||||
1623801|NCT02269709|2981389|Other|Mean IVC pressures from different time points were compared using the Wilcoxon signed-rank test.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1623802|NCT02269709|2981390|Other|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline vs. Follow-up #3|
1623803|NCT02269709|2981390|Other|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline vs. Follow up #2|
1623804|NCT02269709|2981390|Other|Changes in mean liver shear wave speed (SWS) between time points were assessed using a mixed-effect model with post hoc Tukey correction.|||||<|0.0001|||||||Mixed Models Analysis|||Comparison of Baseline and Follow-up #1|
1623805|NCT02269475|2981403|Superiority or Other||Vaccine efficacy (%)|27.5|||||2-Sided|95.0|7.4|43.0|||||Vaccine efficacy (%) = (1-RR)*100 where RR = Risk Reduction.||
1623806|NCT02269475|2981404|Superiority or Other||Vaccine efficacy (%)|100.0|||||2-Sided|95.0|-1875.3|100.0|||||Vaccine efficacy (%) = (1-RR)*100 where RR = Risk Reduction.||
1623807|NCT02269423|2981409|Other|||||||0.918||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28|
1623808|NCT02269423|2981409|Other|||||||0.124||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28|
1623809|NCT02269423|2981409|Other|||||||0.102||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28|
1623810|NCT02269423|2981409|Other||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28|
1623811|NCT02269423|2981409|Other||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28|
1623812|NCT02269423|2981409|Other||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28|
1623813|NCT02269423|2981410|Other|||||||0.173||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28|
1623814|NCT02269423|2981410|Other|||||||0.008||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28|
1623815|NCT02269423|2981410|Other|||||||0.161||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28|
1623816|NCT02269423|2981410|Other||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28|
1623817|NCT02269423|2981410|Other||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28|
1623818|NCT02269423|2981410|Other||||||<|0.001||||||p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.|ANOVA|Adjustments for multiple comparisons were not performed.||Day 28|
1623819|NCT02268942|2981440|Other||||||<|0.0001|||||||t-test, 1 sided|||"The secondary endpoint is an improvement in the mean length of initial hospital stay (initial recovery and step down unit), which is calculated by considering the number of days in acute care (ICU/CCU) plus the number of days in intermediate/step-down care, comprising the total number of days post-implant to discharge.~This secondary endpoint will be calculated using an upper tail one-sided t-test at 0.05 level of significance compared to 26.1 days for median sternotomy patients."|
1623820|NCT02268942|2981441|Other|||||||0.0003|||||||Exact Binomial|||"Success at six months is estimated to be 86% compared to a performance goal of 77.5%. Using an exact binomial test, with a one-sided alpha of 0.05, and 80% Power, a sample size of 145 implanted subjects was planned.~Success will be met if the lower bound of the upper one-sided exact 95% confidence interval is greater than 77.5%."|
1623821|NCT02268526|2981467|Superiority or Other||Risk Ratio (RR)|0.941|||||2-Sided|90.0|0.639|1.377|||||||
1623822|NCT02268526|2981467|Superiority or Other||Risk Ratio (RR)|0.891|||||2-Sided|90.0|0.606|1.305|||||||
1623823|NCT02268214|2981474|Superiority||Odds Ratio (OR)|3.29|Standard Error of the Mean|0.1979|<|0.0001|2-Sided|95.0|2.23|4.85|||Regression, Logistic||||
1623824|NCT02268214|2981474|Superiority||Odds Ratio (OR)|3.09|Standard Error of the Mean|0.198|<|0.0001|2-Sided|95.0|2.1|4.56|||Regression, Logistic||||
1623825|NCT02268214|2981475|Superiority||Mean Difference (Final Values)|10.65|Standard Error of the Mean|1.1689|<|0.0001|2-Sided|95.0|8.35|12.94|||RMM|Repeated Measures Model|||
1623826|NCT02268214|2981475|Superiority||Mean Difference (Final Values)|9.11|Standard Error of the Mean|1.1611|<|0.0001|2-Sided|95.0|6.83|11.39|||RMM|Repeated Measures Model|||
1623827|NCT02268214|2981476|Superiority||Mean Difference (Final Values)|-18.93|Standard Error of the Mean|2.6482|<|0.0001|2-Sided|95.0|-24.13|-13.73|||RMM|Repeated Measures Model|||
1623828|NCT02268214|2981476|Superiority||Mean Difference (Final Values)|-17.3|Standard Error of the Mean|2.6273|<|0.0001|2-Sided|95.0|-22.46|-12.14|||RMM|Repeated Measures Model|||
1623829|NCT02268214|2981477|Superiority||Mean Difference (Final Values)|-18.03|Standard Error of the Mean|2.505|<|0.0001|2-Sided|95.0|-22.95|-13.11|||RMM|Repeated Measures Model|||
1623830|NCT02268214|2981477|Superiority||Mean Difference (Final Values)|-15.34|Standard Error of the Mean|2.4859|<|0.0001|2-Sided|95.0|-20.22|-10.46|||RMM|Repeated Measures Model|||
1623831|NCT02268214|2981478|Superiority||Mean Difference (Final Values)|-3.72|Standard Error of the Mean|0.3213|<|0.0001|2-Sided|95.0|-4.34|-3.08|||RMM|Repeated Measures Model|||
1623832|NCT02268214|2981478|Superiority||Mean Difference (Final Values)|-3.05|Standard Error of the Mean|0.3251|<|0.0001|2-Sided|95.0|-3.68|-2.41|||RMM|Repeated Measures Model|||
1623833|NCT02268214|2981479|Superiority||Mean Difference (Final Values)|-13.17|Standard Error of the Mean|1.8643|<|0.0001|2-Sided|95.0|-16.75|-9.43|||RMM|Repeated Measures Model|||
1623834|NCT02268214|2981479|Superiority||Mean Difference (Final Values)|-8.8|Standard Error of the Mean|1.9555|<|0.0001|2-Sided|95.0|-12.56|-4.88|||RMM|Repeated Measures Model|||
1623835|NCT02268214|2981480|Superiority||Median Difference (Final Values)|-0.45|Standard Error of the Mean|0.0696|<|0.0001|2-Sided|95.0|-0.58|-0.31|||RMM|Repeated Measures Model|||
1623836|NCT02268214|2981480|Superiority||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.0697|<|0.0001|2-Sided|95.0|-0.56|-0.28|||RMM|Repeated Measures Model|||
1623837|NCT02268175|2981485|Superiority|||||||0.151||||||1-sided|Fisher Exact|||The hypothesis was that treatment with ARM 1 will have a pCR/MRD rate of 35% compared with Arm 2 rate of 10%. Given 75 men randomized in 2:1 ratio to Arm 1 (N=50) or Arm 2 (N=25), there was 84% power to detect this difference, using Fisher’s exact test with one-sided type I error of 0.1.|
1623838|NCT02268045|2981490|Other|||||||0.457|||||||Log Rank||||
1623839|NCT02268045|2981494|Equivalence|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%–125%.|ratio RTXM83 to Mabthera|104.0|||||2-Sided|90.0|99.5|109.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator||
1623840|NCT02268045|2981495|Equivalence|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%–125%.|ratio RTXM83 to Mabthera|99.6|||||2-Sided|90.0|93.9|105.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator||
1623841|NCT02268045|2981496|Equivalence|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%–125%.|ratio RTXM83 to Mabthera|103.0|||||2-Sided|90.0|98.5|107.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator||
1623842|NCT02268045|2981497|Equivalence|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%–125%.|ratio RTXM83 to Mabthera|99.2|||||2-Sided|90.0|93.6|105.0|||||For the ratio: RTXM83 represents the numerator and Mabthera the denominator||
1623843|NCT02268045|2981498|Non-Inferiority or Equivalence (legacy)|The RR, with the corresponding 95% CI, was calculated for each treatment arm and compared using Fisher's exact test at a one-sided 0.025 type I error rate. A non-inferiority margin of 13% was assumed with ≥ 80% power to detect treatment differences. Non-inferiority was concluded if the one-sided 95% CI was above the -13% margin set for the study.|percentage difference|3.0|||||1-Sided|95.0|-13.0||||||For the PP population||
1623844|NCT02268045|2981498|Non-Inferiority or Equivalence (legacy)|The RR, with the corresponding 95% CI, was calculated for each treatment arm and compared using Fisher's exact test at a one-sided 0.025 type I error rate. A non-inferiority margin of 13% was assumed with ≥ 80% power to detect treatment differences. Non-inferiority was concluded if the one-sided 95% CI was above the -13% margin set for the study.|Percentage difference|0.7|||||1-Sided|95.0|-13.0||||||For the ITT population||
1623845|NCT02267746|2981505|Equivalence|Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval [-0.20, +0.20] for PP population.|Mean Difference (Net)|-0.073|||||2-Sided|90.0|-0.15|0.004|||||Therapeutic equivalence was established if the 90% CI for the difference was contained within the interval [-0.20, +0.20] for the PP population.|Success was defined as an IGA score at Week 12 that was at least two grades less than the baseline assessment. Failure was defined as an IGA score that was the same, higher, or one grade lower than the baseline assessment.|
1623846|NCT02267746|2981506|Equivalence|Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller’s method.|Mean Difference (Net)|0.96|||||2-Sided|90.0|0.89|1.04|||||Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval [0.80, 1.25] for the PP population.||
1623847|NCT02267746|2981507|Equivalence|Estimates of mean percent change from baseline were calculated (separately for inflammatory and non-inflammatory lesions) for the Test and Reference treatment, and then the 90% confidence interval (CI) for the mean ratio was constructed using Fieller’s method.|Mean Difference (Net)|0.93|||||2-Sided|90.0|0.86|1.02|||||Therapeutic equivalence was established if the 90% CIs for the ratio of Test/Reference means, for both lesion types, were contained within the interval [0.80, 1.25] for the PP population.||
1623873|NCT02267538|2981523|Other|stroke|Odds Ratio (OR)|1.01||||0.993|2-Sided|95.0|0.2|5.08|||Regression, Logistic|||Incidence of stroke within 30 days after surgery|
1623874|NCT02267538|2981523|Other||Odds Ratio (OR)|0.74||||0.214|2-Sided|95.0|0.47|1.19|||Regression, Logistic|||Incidence of total non-delirium complications within 30 days after surgery|
1623875|NCT02267538|2981524|Other||Median Difference (Final Values)|0.0||||0.405|2-Sided|||||m-TICS|Wilcoxon (Mann-Whitney)||||
1623876|NCT02267538|2981524|Other||Median Difference (Final Values)|0.0||||0.83|2-Sided|||||MMSE|Wilcoxon (Mann-Whitney)||||
1623877|NCT02267538|2981525|Other||Odds Ratio (OR)|0.62||||0.341|2-Sided|95.0|0.23|1.65|||Regression, Logistic||||
1623922|NCT02265705|2981726|Superiority||Median Difference (Final Values)|-12.9||||0.004|2-Sided|95.0|-28.0|-2.9|||Wilcoxon (Mann-Whitney)||||
1623848|NCT02267603|2981516|Other|The null hypothesis will be rejected if 3 or more responses are observed in 24 patients. This design yields a type I error rate of 0.10 and power of 0.90 when the true response rate is 25%. Progression-free survival (PFS) at 16 months will be estimated by Kaplan-Meier method. Unless otherwise stated, all statistical tests will be conducted at the α=0.05 (1-sided) level.||||||||||||||||The protocol has a standard Simon two stage design. The null hypothesis that the true response rate is 5% will be tested against a one-sided alternative. In the first stage, 9 patients will be accrued. If there are no responses in these 9 patients, the study will be stopped. Otherwise, 15 additional patients will be accrued for a total of 24. The current protocol will increase the total number of patients from 26 to 50.|ORR will be estimated as the # of responders as a % of the # of eligible participants who received at least 1 dose of treatment. If a substantial amount of primary endpoint data are missing (at least 1 value missing from more than 20% of participants), using nonparametric estimation to estimate the ORR requires the missing completely at random assumption may give misleading results. In this case, analyses of the primary endpoint will be performed using parametric generalized linear models fit by maximum likelihood. These methods provide unbiased estimation and inferences under the parametric modeling assumptions and the assumption that the missing data are missing at random (MAR). MAR assumes that the probability of an observation being missing may depend upon the observed responses and upon observed covariates. A generalized linear model for the ORR will use a binomial error distribution. The model will include as covariates all available baseline predictors of the missing outcomes.
1623849|NCT02267538|2981519|Other||Hazard Ratio (HR)|0.97||||0.826|2-Sided|95.0|0.77|1.23|||Log Rank||||
1623850|NCT02267538|2981520|Other||Hazard Ratio (HR)|1.03||||0.788|2-Sided|95.0|0.82|1.31|||Log Rank||||
1623851|NCT02267538|2981521|Other||Median Difference (Final Values)|0.0||||0.174|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fifth row in Outcome 5, i.e., subjective sleep quality in Day 5 after surgery, between DEX Group and CTRL group|
1623852|NCT02267538|2981521|Other||Median Difference (Final Values)|0.0||||0.321|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fourth row in Outcome 5, i.e., subjective sleep quality in Day 4 after surgery, between DEX Group and CTRL group|
1623853|NCT02267538|2981521|Other||Median Difference (Final Values)|0.0||||0.835|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the third row in Outcome 5, i.e., subjective sleep quality in Day 3 after surgery, between DEX Group and CTRL group|
1623854|NCT02267538|2981521|Other||Median Difference (Final Values)|0.0||||0.919|2-Sided|95.0|-1.0|1.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the second row in Outcome 5, i.e., subjective sleep quality in Day 2 after surgery, between DEX Group and CTRL group|
1623855|NCT02267538|2981521|Other||Median Difference (Final Values)|0.0||||0.777|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the first row in Outcome 5, i.e., subjective sleep quality in Day 1 after surgery, between DEX Group and CTRL group|
1623856|NCT02267538|2981522|Other||Median Difference (Final Values)|0.0||||0.378|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the tenth row in Outcome 4, i.e., Pain score in Day 5 after surgery, with coughing between DEX Group and CTRL group|
1623857|NCT02267538|2981522|Other||Median Difference (Final Values)|0.0||||0.127|2-Sided|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the ninth row in Outcome 4, i.e., Pain score in Day 4 after surgery, with coughing between DEX Group and CTRL group|
1623858|NCT02267538|2981522|Other||Median Difference (Final Values)|0.0||||0.187|2-Sided|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the eighth row in Outcome 4, i.e., Pain score in Day 3 after surgery, with coughing between DEX Group and CTRL group|
1623859|NCT02267538|2981522|Other||Median Difference (Final Values)|0.0||||0.414|2-Sided|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the seventh row in Outcome 4, i.e., Pain score in Day 2 after surgery, with coughing between DEX Group and CTRL group|
1623860|NCT02267538|2981522|Other||Median Difference (Final Values)|0.0||||0.486|2-Sided|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the sixth row in Outcome 4, i.e., Pain score in Day 1 after surgery, with coughing between DEX Group and CTRL group|
1623861|NCT02267538|2981522|Other||Median Difference (Final Values)|0.0||||0.397|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fifth row in Outcome 4, i.e., Pain score in Day 5 after surgery, at rest between DEX Group and CTRL group|
1623862|NCT02267538|2981522|Other||Median Difference (Final Values)|0.0||||0.368|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the fourth row in Outcome 4, i.e., Pain score in Day 4 after surgery, at rest between DEX Group and CTRL group|
1623863|NCT02267538|2981522|Other||Median Difference (Final Values)|0.0||||0.282|2-Sided|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the third row in Outcome 4, i.e., Pain score in Day 3 after surgery, at rest between DEX Group and CTRL group|
1623864|NCT02267538|2981522|Other||Median Difference (Final Values)|0.0||||0.743|2-Sided|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the second row in Outcome 4, i.e., Pain score in Day 2 after surgery, at rest between DEX Group and CTRL group|
1623865|NCT02267538|2981522|Other||Median Difference (Final Values)|0.0||||0.596|2-Sided|95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)|||this statistical analysis applies to the first row in Outcome 4, i.e., Pain score in Day 1 after surgery, at rest between DEX Group and CTRL group|
1623866|NCT02267538|2981523|Other||Odds Ratio (OR)|0.48||||0.156|2-Sided|95.0|0.18|1.32||IABP assistance|Regression, Logistic||||
1623867|NCT02267538|2981523|Other||Odds Ratio (OR)|0.79||||0.378|2-Sided|95.0|0.47|1.33||Acute kidney injur|Regression, Logistic||||
1623868|NCT02267538|2981523|Other||Odds Ratio (OR)|1.63||||0.326|2-Sided|95.0|0.61|4.34||Wound dehiscence or infection|Regression, Logistic||||
1623869|NCT02267538|2981523|Other||Odds Ratio (OR)|1.01||||0.993|2-Sided|95.0|0.2|5.08||Surgical bleeding|Regression, Logistic||||
1623870|NCT02267538|2981523|Other||Odds Ratio (OR)|0.5||||0.423|2-Sided|95.0|0.09|2.75||Upper gastrointestinal bleeding|Regression, Logistic||||
1623871|NCT02267538|2981523|Other|Pulmonary complications|Odds Ratio (OR)|0.51||||0.05|2-Sided|95.0|0.26|1.0|||Regression, Logistic||||
1623872|NCT02267538|2981523|Other|New onset arrythmia|Odds Ratio (OR)|0.76||||0.274|2-Sided|95.0|0.46|1.25|||Regression, Logistic||||
1623878|NCT02267135|2981560|Superiority or Other||Difference between percentages|51.0|||<|0.001|2-Sided|95.0|37.0|65.0|||Cochran-Mantel-Haenszel|adjusted for body weight (< 90 kg, ≥ 90 kg)|||
1623879|NCT02266875|2981567|Superiority||||||>|0.999|||||||Fisher Exact||||
1623880|NCT02266875|2981568|Superiority|||||||0.32|||||||t-test, 2 sided||||
1623881|NCT02266576|2981615|Other|||||||0.01|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 12 in physical component score|
1623882|NCT02266576|2981615|Other|||||||0.004|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 6 in physical component score|
1623883|NCT02266576|2981616|Other|||||||0.02|||||||Regression, Linear|The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.||Baseline vs month 12|
1623884|NCT02266576|2981616|Other|||||||0.04||||||The linear regression model was used, adjusted for within cohort correlation, within participant correlation, and gender.|Regression, Linear|||Baseline vs month 6|
1623885|NCT02266472|2981617|Non-Inferiority or Equivalence|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|101.37|Standard Deviation|11.0|||2-Sided|90.0|96.53|106.45|||||Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).||
1623886|NCT02266472|2981618|Non-Inferiority or Equivalence|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|98.89|Standard Deviation|6.3|||2-Sided|90.0|96.18|101.67|||||Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).||
1623887|NCT02266472|2981619|Non-Inferiority or Equivalence|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|108.58|Standard Deviation|9.3|<|0.0001|2-Sided|90.0|104.17|113.17|||ANOVA|ANOVA model on the logarithmic scale including random effects for ‘subjects within sequences’ & fixed effect for ‘sequence’, ‘period’ & ‘treatment’.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).||
1623888|NCT02266472|2981620|Non-Inferiority or Equivalence|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00%.|ratio of the adjusted means|99.12|Standard Deviation|12.9|<|0.0001|2-Sided|90.0|93.69|104.87|||ANOVA|ANOVA model on the logarithmic scale including random effects for ‘subjects within sequences’ & fixed effect for ‘sequence’, ‘period’ & ‘treatment’.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed10mg+1000mg FDC divided by Fed10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).||
1623889|NCT02266472|2981621|Non-Inferiority or Equivalence|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints,using an acceptance range of 80.00 to 125.00 %.|ratio of the adjusted means|101.25|Standard Deviation|10.7|<|0.0001|2-Sided|90.0|96.54|106.19|||ANOVA|ANOVA model on the logarithmic scale including random effects for ‘subjects within sequences’ & fixed effect for ‘sequence’, ‘period’ & ‘treatment’.|Relative bioavailability of metformin was estimated by the adjusted gMean ratio of Fed 10mg+1000mg FDC divided by Fed 10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).||
1623890|NCT02266472|2981622|Non-Inferiority or Equivalence|The assessment of bioequivalence was based on 2-sided 90% CIs for the ratios (test to reference treatment) of the adjusted gMeans of the primary endpoints, with acceptance range of 80.00 to 125.00 %.|ratio of the adjusted means|99.11|Standard Deviation|6.3|<|0.0001|2-Sided|90.0|96.4|101.89|||ANOVA|ANOVA model on the logarithmic scale including random effects for ‘subjects within sequences’ & fixed effect for ‘sequence’, ‘period’ & ‘treatment’.|Relative bioavailability of empagliflozin was estimated by the adjusted gMean ratio of Fed 10mg+1000mg FDC divided by Fed 10mg+1000mg Single. Standard deviation is actually intraindividual geometric coefficient variation (gCV).||
1623891|NCT02266277|2981628|Superiority|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|1.04||||0.76|2-Sided|95.0|0.82|1.31|||Regression, Logistic||||
1623892|NCT02266277|2981628|Superiority|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.99||||0.96|2-Sided|95.0|0.79|1.25|||Regression, Logistic||||
1623893|NCT02266277|2981628|Superiority|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.87||||0.23|2-Sided|95.0|0.69|1.09|||Regression, Logistic||||
1623894|NCT02266277|2981628|Superiority|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|0.89||||0.33|2-Sided|95.0|0.71|1.13|||Regression, Logistic||||
1623895|NCT02266277|2981628|Superiority|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio, log|0.9||||0.36|2-Sided|95.0|0.71|1.13|||Regression, Logistic||||
1623896|NCT02266277|2981628|Superiority|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Odds Ratio (OR)|1.03||||0.82|2-Sided|95.0|0.81|1.31|||Regression, Logistic||||
1623897|NCT02266277|2981629|Superiority|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|0.99||||0.87|2-Sided|95.0|0.86|1.14|||Regression, Logistic||||
1623898|NCT02266277|2981629|Superiority|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio, log|1.12||||0.0579|2-Sided|95.0|0.996|1.26|||Regression, Logistic||||
1623899|NCT02266277|2981629|Superiority|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.07||||0.233|2-Sided|95.0|0.96|1.21|||Regression, Logistic||||
1623900|NCT02266277|2981629|Superiority|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.16||||0.0206|2-Sided|95.0|1.02|1.31|||Regression, Logistic||||
1623901|NCT02266277|2981629|Superiority|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.2||||0.0026|2-Sided|95.0|1.07|1.36|||Regression, Logistic||||
1623902|NCT02266277|2981629|Superiority|"We calculated frequencies and performed intention-to-treat bivariate analyses. We then performed multivariate logistic regression analyses.~With our proposed sample size and using a factorial design, power calculations based on estimates of baseline vaccination rates indicated that 4286 participants per arm would give 80% power to detect a 3% improvement in influenza vaccination rates between groups (α=.05; 2-sided)."|Odds Ratio (OR)|1.3||||0.0001|2-Sided|95.0|1.15|1.47||Adjusted for age, sex, race and utilization|Regression, Logistic||||
1623903|NCT02265796|2981685|Superiority||||||>|0.05|||||||Fisher Exact||||
1623904|NCT02265796|2981686|Superiority|||||||0.067|||||||McNemar|||within group comparison of change from baseline for fair/poor|
1623905|NCT02265796|2981686|Superiority|||||||0.19|||||||McNemar|||within group analysis of change from baseline for excellent/good|
1623906|NCT02265796|2981686|Superiority|||||||0.48|||||||McNemar|||within group comparison of change from baseline for fair/poor|
1623907|NCT02265796|2981686|Superiority|||||||0.5|||||||McNemar|||within group analysis of change from baseline for excellent/good|
1623908|NCT02265796|2981686|Superiority|||||||0.8|||||||Fisher Exact|||"Between group analysis for fair/poor"|
1623909|NCT02265796|2981686|Superiority|||||||0.58|||||||Fisher Exact|||"between group comparison for the excellent/good"|
1623910|NCT02265796|2981687|Superiority||||||<|0.05||||||reported p value is for the angina stability, angina frequency and quality of life domains|paired t test|||within group comparison of change from baseline|
1623911|NCT02265796|2981687|Superiority||||||>|0.05||||||reported p value is for the physical limitation and treatment satisfaction domains|paired t test|||within group comparison of change from baseline|
1623912|NCT02265796|2981687|Superiority||||||<|0.05||||||reported p value is for the angina stability and quality of life domains|paired t test|||within group comparison of change from baseline|
1623913|NCT02265796|2981687|Superiority||||||>|0.05||||||reported p value is for the physical limitation, angina frequency and treatment satisfaction domains|paired t test|||within group comparison of change from baseline|
1623914|NCT02265796|2981687|Superiority||||||>|0.05||||||the reported p value is for all between group comparisons of the SAQ domains.|t-test, 2 sided|||between group comparison for all SAQ domains|
1623915|NCT02265744|2981722|Superiority|||||||0.9439|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.|||
1623916|NCT02265744|2981722|Superiority|||||||0.8295|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.|||
1623917|NCT02265744|2981722|Superiority|||||||0.6217|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.|||
1623918|NCT02265744|2981722|Superiority|||||||0.9745|||||||Chi-squared|Nominal p-values that are not adjusted for multiplicity.|||
1623919|NCT02265705|2981723|Superiority||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.2||0.001|2-Sided|95.0|-1.3|-0.5|||ANCOVA||||
1623920|NCT02265705|2981724|Superiority||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.2||0.001|2-Sided|95.0|-1.2|-0.4|||ANCOVA||||
1623921|NCT02265705|2981725|Superiority||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.23||0.002|2-Sided|95.0|-1.2|-0.3|||ANCOVA||||
1623924|NCT02265705|2981728|Superiority||Mean Difference (Final Values)|-1.02|Standard Error of the Mean|0.116||0.001|2-Sided|95.0|-1.25|-0.79|||ANCOVA||||
1623925|NCT02265705|2981729|Superiority||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.056||0.001|2-Sided|95.0|-0.31|-0.09|||ANCOVA||||
1623926|NCT02265705|2981730|Superiority||Odds Ratio (OR)|4.1||||0.001|2-Sided|95.0|2.5|6.9|||Regression, Logistic||||
1623927|NCT02265510|2981743|Other||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
1623928|NCT02265510|2981744|Other||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
1623929|NCT02265510|2981745|Other||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
1623930|NCT02265510|2981746|Other||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
1623931|NCT02265510|2981747|Other||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
1623932|NCT02265510|2981748|Other||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
1623933|NCT02265510|2981749|Other||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
1623934|NCT02265510|2981750|Other||||||||||||||||||The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
1623935|NCT02265510|2981751|Other||||||||||||||||||Confidence Intervals for response were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.
1623936|NCT02265510|2981752|Other||||||||||||||||||Confidence Intervals for ORR were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.
1623937|NCT02265510|2981753|Other|Descriptive Statistics|||||||||||||||||The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
1623938|NCT02265237|2981764|Superiority|Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).|Stratum-Adjusted MH Difference|6.45||||0.086|2-Sided|95.0|-0.91|13.81|||Mantel Haenszel|||Within Part II (arm C), since superiority was demonstrated for the primary outcome measure, testing continued to the second secondary outcome measure.|
1623939|NCT02265237|2981765|Superiority|Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel (MH) proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).|Stratum-Adjusted MH Difference|-3.39||||0.304|2-Sided|95.0|-9.85|3.07|||Mantel Haenszel|||Within Part I (arm A and B), since superiority was demonstrated for both arms in the primary outcome measures, testing continued to the first secondary outcome measure.|
1623940|NCT02265237|2981766|Superiority|97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.|Percentage of Participants|93.4|||||2-Sided|97.5|82.6|97.7|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.|
1623941|NCT02265237|2981766|Superiority|97.5% confidence interval (CI) was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV GT4-infected subjects treated with pegIFN/RBV.|Percentage of Participants|96.6|||||2-Sided|97.5|86.7|99.2|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.|
1623942|NCT02265237|2981766|Superiority|97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.|Percentage of Participants|100.0|||||2-Sided|97.5|92.4|100.0|||||The confidence interval was calculated using the Wilson score method.|The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.|
1623943|NCT02264574|2981775|Superiority||||||=|0|||||||Chi-squared||||
1623944|NCT02264574|2981776|Superiority||Hazard Ratio (HR)|0.119|||<|0.001|2-Sided|95.0|0.046|0.307|||Log Rank||||
1623945|NCT02264574|2981777|Superiority||Hazard Ratio (HR)|0.231|||<|0.0001|2-Sided|95.0|0.145|0.367|||Log Rank|||The treatment effect was tested with an unstratified log rank test. The hazard ratio and its 95% confidence internval were based on a Cox regression model with treatment as the only covariate.|
1623946|NCT02264353|2981778|Superiority|||||||0.089|||||||t-test, 2 sided||||
1623947|NCT02264353|2981779|Other|||||||0.394|||||||Wilcoxon (Mann-Whitney)||||
1623948|NCT02264353|2981780|Superiority|||||||0.576|||||||t-test, 2 sided||||
1623949|NCT02263326|2981797|Other||Mean Difference (Final Values)|0.5||||0.76|2-Sided|95.0|-3.0|4.1|||Regression, Linear||||
1623954|NCT02263326|2981803|Non-Inferiority|The difference in virologic outcomes based on the FDA snapshot algorithm at week 48 (HIV RNA <50 copies/mL) was compared between arms, with 95% confidence intervals.|Risk Difference (RD)|0.02|||||2-Sided|95.0|-0.126|0.165|||||||
1623955|NCT02263326|2981804|Non-Inferiority|We considered DTG/3TC was noninferior to cART if the 90% confidence interval for the difference in proportions, calculated with Miettinen-Nurminen (score) confidence limits, excluded the 12% noninferiority margin.|Risk Difference (RD)|0.0015|||||2-Sided|90.0|-0.098|0.102||||||A sample size of 41 participants per arm provided 80% power to show noninferiority of DTG/3TC to cART based on a 12% noninferiority margin, assuming an estimated treatment failure rate of 5% per arm by week 24 and 5% 1-sided type I error rate.|
1623956|NCT02262754|2981828|Superiority or Other||Odds Ratio (OR)|1.97|||||2-Sided|90.0|1.06|3.65||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.|
1623957|NCT02262754|2981828|Superiority or Other||Odds Ratio (OR)|0.43|||||2-Sided|90.0|0.23|0.81||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.|
1623958|NCT02262754|2981828|Superiority or Other||Odds Ratio (OR)|0.85|||||2-Sided|90.0|0.46|1.56||||||Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.|
1623959|NCT02262754|2981829|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.33|Standard Error of the Mean|0.19|||2-Sided|90.0|0.02|0.63||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.|
1623960|NCT02262754|2981829|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.43|Standard Error of the Mean|0.19|||2-Sided|90.0|-0.75|-0.12||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.|
1623961|NCT02262754|2981829|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.11|Standard Error of the Mean|0.19|||2-Sided|90.0|-0.42|0.21||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.|
1623962|NCT02262754|2981829|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.31|Standard Error of the Mean|0.17|||2-Sided|90.0|0.03|0.59||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.|
1623963|NCT02262754|2981829|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.38|Standard Error of the Mean|0.17|||2-Sided|90.0|-0.67|-0.1||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.|
1623964|NCT02262754|2981829|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.07|Standard Error of the Mean|0.17|||2-Sided|90.0|-0.36|0.21||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.|
1623965|NCT02262754|2981829|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.2|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.09|0.49||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.|
1623966|NCT02262754|2981829|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.29|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.58|0.01||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.|
1623967|NCT02262754|2981829|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.08|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.38|0.21||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.|
1623968|NCT02262754|2981829|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.2|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.05|0.45||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.|
1623969|NCT02262754|2981829|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.37|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.62|-0.12||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.|
1623970|NCT02262754|2981829|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.17|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.42|0.08||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.|
1623971|NCT02262754|2981830|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.33|Standard Error of the Mean|0.15|||2-Sided|90.0|0.08|0.58||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.|
1623972|NCT02262754|2981830|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.21|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.46|0.05||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.|
1624212|NCT02255097|2982458|Superiority or Other (legacy)||||||<|0.001|||||||exact binomial distribution|null hypothesis (H0): p ≤ 0.05 versus alternate hypothesis (H1): p > 0.05|||
1623973|NCT02262754|2981830|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|0.12|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.13|0.38||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.|
1623974|NCT02262754|2981830|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.13|Standard Error of the Mean|0.14|||2-Sided|90.0|-0.1|0.36||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.|
1623975|NCT02262754|2981830|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|0.02|Standard Error of the Mean|0.14|||2-Sided|90.0|-0.21|0.25||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.|
1623976|NCT02262754|2981830|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|0.15|Standard Error of the Mean|0.14|||2-Sided|90.0|-0.09|0.38||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.|
1623977|NCT02262754|2981830|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.11|Standard Error of the Mean|0.13|||2-Sided|90.0|-0.1|0.33||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.|
1623978|NCT02262754|2981830|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.15|Standard Error of the Mean|0.13|||2-Sided|90.0|-0.37|0.07||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.|
1623979|NCT02262754|2981830|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.04|Standard Error of the Mean|0.13|||2-Sided|90.0|-0.26|0.18||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.|
1623980|NCT02262754|2981830|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.15|Standard Error of the Mean|0.12|||2-Sided|90.0|-0.05|0.35||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.|
1623981|NCT02262754|2981830|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.14|Standard Error of the Mean|0.12|||2-Sided|90.0|-0.34|0.05||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.|
1623982|NCT02262754|2981830|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|0.01|Standard Error of the Mean|0.12|||2-Sided|90.0|-0.19|0.2||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.|
1623983|NCT02262754|2981831|Superiority or Other||Odds Ratio (OR)|0.48|||||2-Sided|90.0|0.31|0.74||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.|
1623984|NCT02262754|2981831|Superiority or Other||Odds Ratio (OR)|2.04|||||2-Sided|90.0|1.33|3.14||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.|
1623985|NCT02262754|2981831|Superiority or Other||Odds Ratio (OR)|0.98|||||2-Sided|90.0|0.61|1.58||||||A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.|
1623986|NCT02262754|2981832|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|-0.74|Standard Error of the Mean|0.33|||2-Sided|90.0|-1.29|-0.2||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.|
1623987|NCT02262754|2981832|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.11|Standard Error of the Mean|0.34|||2-Sided|90.0|-0.67|0.46||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.|
1623988|NCT02262754|2981832|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.85|Standard Error of the Mean|0.34|||2-Sided|90.0|-1.42|-0.28||||||Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.|
1624004|NCT02262754|2981834|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.41|Standard Error of the Mean|0.59|||2-Sided|90.0|-0.57|1.39||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1623989|NCT02262754|2981832|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|-0.6|Standard Error of the Mean|0.37|||2-Sided|90.0|-1.21|0.02||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.|
1623990|NCT02262754|2981832|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.17|Standard Error of the Mean|0.38|||2-Sided|90.0|-0.8|0.45||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.|
1623991|NCT02262754|2981832|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.77|Standard Error of the Mean|0.38|||2-Sided|90.0|-1.39|-0.15||||||Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.|
1623992|NCT02262754|2981832|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.19|Standard Error of the Mean|0.61|||2-Sided|90.0|-0.82|1.19||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.|
1623993|NCT02262754|2981832|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-1.21|Standard Error of the Mean|0.63|||2-Sided|90.0|-2.25|-0.17||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.|
1623994|NCT02262754|2981832|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-1.02|Standard Error of the Mean|0.63|||2-Sided|90.0|-2.06|0.02||||||Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.|
1623995|NCT02262754|2981832|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.58|Standard Error of the Mean|0.68|||2-Sided|90.0|-0.56|1.71||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.|
1623996|NCT02262754|2981832|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.95|Standard Error of the Mean|0.7|||2-Sided|90.0|-2.1|0.2||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.|
1623997|NCT02262754|2981832|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.37|Standard Error of the Mean|0.7|||2-Sided|90.0|-1.52|0.78||||||Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.|
1623998|NCT02262754|2981833|Superiority or Other||Mean Difference (PF-06372865-Naproxen)|0.79|||||2-Sided|90.0|-0.22|1.8||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.|
1623999|NCT02262754|2981833|Superiority or Other||Mean Difference (Naproxen-Placebo)|-1.43|||||2-Sided|90.0|-2.4|-0.45||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.|
1624000|NCT02262754|2981833|Superiority or Other||Mean Difference (PF-06372865-Placebo)|-0.64|||||2-Sided|90.0|-1.63|0.35||||||Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.|
1624001|NCT02262754|2981834|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.86|Standard Error of the Mean|0.6|||2-Sided|90.0|-0.12|1.85||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624002|NCT02262754|2981834|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-1.27|Standard Error of the Mean|0.61|||2-Sided|90.0|-2.28|-0.27||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624003|NCT02262754|2981834|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.41|Standard Error of the Mean|0.61|||2-Sided|90.0|-1.42|0.6||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624005|NCT02262754|2981834|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-1.11|Standard Error of the Mean|0.6|||2-Sided|90.0|-2.11|-0.11||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624006|NCT02262754|2981834|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.7|Standard Error of the Mean|0.6|||2-Sided|90.0|-1.69|0.29||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624007|NCT02262754|2981834|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.73|Standard Error of the Mean|0.53|||2-Sided|90.0|-0.15|1.61||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624008|NCT02262754|2981834|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.91|Standard Error of the Mean|0.53|||2-Sided|90.0|-1.8|-0.03||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624009|NCT02262754|2981834|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.18|Standard Error of the Mean|0.53|||2-Sided|90.0|-1.06|0.7||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624010|NCT02262754|2981840|Superiority or Other||Odds Ratio (OR)|0.73|||||2-Sided|90.0|0.33|1.6||||||>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.|
1624011|NCT02262754|2981840|Superiority or Other||Odds Ratio (OR)|1.11|||||2-Sided|90.0|0.53|2.35||||||>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.|
1624012|NCT02262754|2981840|Superiority or Other||Odds Ratio (OR)|0.81|||||2-Sided|90.0|0.37|1.81||||||>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.|
1624013|NCT02262754|2981840|Superiority or Other||Odds Ratio (OR)|0.68|||||2-Sided|90.0|0.39|1.2||||||>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.|
1624014|NCT02262754|2981840|Superiority or Other||Odds Ratio (OR)|1.43|||||2-Sided|90.0|0.81|2.51||||||>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.|
1624015|NCT02262754|2981840|Superiority or Other||Odds Ratio (OR)|0.97|||||2-Sided|90.0|0.54|1.73||||||>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.|
1624016|NCT02262754|2981841|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.09|Standard Error of the Mean|0.09|||2-Sided|90.0|-0.05|0.23||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.|
1624017|NCT02262754|2981841|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.1|Standard Error of the Mean|0.09|||2-Sided|90.0|-0.24|0.05||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.|
1624018|NCT02262754|2981841|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.01|Standard Error of the Mean|0.09|||2-Sided|90.0|-0.16|0.14||||||Week 4: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.|
1624019|NCT02262754|2981841|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.05|Standard Error of the Mean|0.07|||2-Sided|90.0|-0.07|0.16||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.|
1624020|NCT02262754|2981841|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.05|Standard Error of the Mean|0.07|||2-Sided|90.0|-0.16|0.07||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.|
1624021|NCT02262754|2981841|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|0.0|Standard Error of the Mean|0.07|||2-Sided|90.0|-0.12|0.12||||||Week 3: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.|
1624022|NCT02262754|2981841|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.06|Standard Error of the Mean|0.06|||2-Sided|90.0|-0.04|0.15||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.|
1624023|NCT02262754|2981841|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.05|Standard Error of the Mean|0.06|||2-Sided|90.0|-0.15|0.05||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.|
1624024|NCT02262754|2981841|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|0.01|Standard Error of the Mean|0.06|||2-Sided|90.0|-0.09|0.1||||||Week 2: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.|
1624025|NCT02262754|2981841|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.06|Standard Error of the Mean|0.03|||2-Sided|90.0|0.01|0.12||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.|
1624026|NCT02262754|2981841|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.04|Standard Error of the Mean|0.03|||2-Sided|90.0|-0.09|0.02||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.|
1624027|NCT02262754|2981841|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|0.03|Standard Error of the Mean|0.03|||2-Sided|90.0|-0.03|0.08||||||Week 1: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.|
1624028|NCT02262754|2981842|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.44|Standard Error of the Mean|0.28|||2-Sided|90.0|-0.03|0.91||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624029|NCT02262754|2981842|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.37|Standard Error of the Mean|0.29|||2-Sided|90.0|-0.84|0.11||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624030|NCT02262754|2981842|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|0.07|Standard Error of the Mean|0.29|||2-Sided|90.0|-0.4|0.55||||||Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624031|NCT02262754|2981842|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.3|Standard Error of the Mean|0.25||||90.0|-0.12|0.71||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624032|NCT02262754|2981842|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.27|Standard Error of the Mean|0.26|||2-Sided|90.0|-0.69|0.16||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624033|NCT02262754|2981842|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|0.03|Standard Error of the Mean|0.26|||2-Sided|90.0|-0.39|0.45||||||Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624034|NCT02262754|2981842|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.19|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.19|0.58||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624035|NCT02262754|2981842|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.24|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.62|0.15||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624036|NCT02262754|2981842|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.05|Standard Error of the Mean|0.24|||2-Sided|90.0|-0.43|0.34||||||Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624037|NCT02262754|2981842|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|0.28|Standard Error of the Mean|0.17|||2-Sided|90.0|0.01|0.56||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624038|NCT02262754|2981842|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|-0.2|Standard Error of the Mean|0.17|||2-Sided|90.0|-0.48|0.07||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624039|NCT02262754|2981842|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|0.08|Standard Error of the Mean|0.17|||2-Sided|90.0|-0.2|0.36||||||Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.|
1624040|NCT02262754|2981843|Superiority or Other||LS Mean Difference(PF-06372865-Naproxen)|-0.35|Standard Error of the Mean|0.32|||2-Sided|90.0|-0.87|0.17||||||The ANCOVA model included treatment as fixed effects.|
1624041|NCT02262754|2981843|Superiority or Other||LS Mean Difference (Naproxen-Placebo)|0.12|Standard Error of the Mean|0.32|||2-Sided|90.0|-0.41|0.65||||||The ANCOVA model included treatment as fixed effects.|
1624042|NCT02262754|2981843|Superiority or Other||LS Mean Difference (PF-06372865-Placebo)|-0.23|Standard Error of the Mean|0.32|||2-Sided|90.0|-0.76|0.3||||||The ANCOVA model included treatment as fixed effects.|
1624043|NCT02262754|2981849|Superiority or Other||Mean Difference (Naproxen-Placebo)|-0.26|||||2-Sided|90.0|-0.7|0.18||||||An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.|
1624044|NCT02262754|2981849|Superiority or Other||Mean Difference (PF-06372865-Naproxen)|0.42|||||2-Sided|90.0|-0.02|0.87||||||An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.|
1624045|NCT02262754|2981849|Superiority or Other||Mean Difference (PF-06372865-Placebo)|0.16|||||2-Sided|90.0|-0.28|0.6||||||An analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward (LOCF) was used for missing data.|
1624046|NCT02262377|2981863|Superiority||Odds Ratio (OR)|1.01|||||2-Sided|95.0|0.9|1.14|||||||
1624047|NCT02262377|2981864|Superiority||Odds Ratio (OR)|0.42|||||2-Sided|95.0|0.18|0.98|||||||
1624048|NCT02262377|2981865|Superiority||Risk Ratio (RR)|1.0||||0.98|2-Sided|95.0|0.89|1.13|||Regression, Poisson||||
1624049|NCT02262377|2981866|Superiority||Risk Ratio (RR)|1.17||||0.054|2-Sided|95.0|0.99|1.37|||Regression, Poisson||||
1624050|NCT02262377|2981867|Superiority|The ITT analysis was done for 21 week BPI Severity.|Risk Ratio (RR)|1.0||||0.996|2-Sided|95.0|0.86|1.16||Statistical significance was set at p< 0.05.|Regression, Poisson||||
1624051|NCT02262377|2981867|Superiority|The ITT analysis was done for 21 week BPI Interference.|Risk Ratio (RR)|0.98||||0.36|2-Sided|95.0|0.88|1.08||Statistical significance was set at p< 0.05.|Regression, Poisson||||
1624052|NCT02262377|2981867|Superiority|The ITT analysis was done for 21 week average pain.|Risk Ratio (RR)|1.03||||0.68|2-Sided|95.0|0.92|1.15||Statistical significance was set at p< 0.05.|Regression, Poisson|||Intention to Treat Analysis for average chronic pain.|
1624053|NCT02262260|2981872|Non-Inferiority|comparison was made between the two groups using the Independent Samples t-test||||||0.466|||||||Chi-squared||||
1624054|NCT02262260|2981873|Non-Inferiority|comparison was made between the two groups using the Independent Samples t-test.||||||0.072|||||||Chi-squared||||
1624055|NCT02262260|2981874|Non-Inferiority|Comparison was made between the two groups using the Independent Samples t-test.||||||0.095|||||||Chi-squared||||
1624056|NCT02262260|2981877|Non-Inferiority|In order to demonstrate that the “wait and extend” regimen of ranibizumab is non-inferior to the posology described in the prescribing information, mean change in Central Retinal Thickness determined with Optical Coherence Tomography for both eyes were calculated for both groups and were compared using the Mann Whitney u test.||||||0.082|||||||Wilcoxon (Mann-Whitney)||||
1624057|NCT02262260|2981878|Non-Inferiority|In order to demonstrate that the “wait and extend” regimen of ranibizumab is non-inferior to the posology described in the prescribing information, mean change in BCVA at month 12 from the baseline visit were determined for both treatment groups, and a comparison was made between the two groups using the Independent Samples t-test.||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1624058|NCT02262078|2981884|Superiority or Other|||||||0.002|||||||t-test, 2 sided||||
1624059|NCT02262039|2981885|Superiority or Other|||||||0.45|||||||t-test, 2 sided||||
1624060|NCT02262039|2981886|Superiority or Other|||||||0.82|||||||t-test, 2 sided||||
1624061|NCT02262039|2981887|Superiority or Other|||||||0.25|||||||t-test, 2 sided||||
1624062|NCT02262039|2981888|Superiority or Other|||||||0.52|||||||t-test, 2 sided||||
1624063|NCT02262039|2981889|Superiority or Other|||||||0.78|||||||t-test, 2 sided||||
1624064|NCT02262039|2981890|Superiority or Other|||||||0.92|||||||t-test, 2 sided||||
1624065|NCT02262039|2981891|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1624066|NCT02261428|2981930|Superiority or Other||Odds Ratio (OR)|3.95|||<|0.05|2-Sided|95.0|1.79|8.73|||Wilcoxon (Mann-Whitney)||||
1624067|NCT02260986|2981949|Superiority||LS mean difference|-1.0||||0.1596|2-Sided|95.0|-2.27|0.37||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.|
1624068|NCT02260986|2981950|Superiority||LS mean difference|-7.4|||<|0.0001|2-Sided|95.0|-8.85|-5.93||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.|
1624069|NCT02260986|2981951|Superiority||LS mean difference|-4.2|||<|0.0001|2-Sided|95.0|-5.31|-3.02||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.|
1624070|NCT02260986|2981952|Superiority||LS mean difference|-27.7|||<|0.0001|2-Sided|95.0|-33.46|-21.9||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.|
1624123|NCT02260934|2981982|Superiority|||||||0.58||||||Two-sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 24|
1624225|NCT02254408|2982491|Superiority||Odds Ratio (OR)|1.01||||0.98|2-Sided|95.0|0.28|3.63|||Cochran-Mantel-Haenszel||||
1624071|NCT02260986|2981953|Superiority||LS mean difference|-18.38|||<|0.0001|2-Sided|95.0|-22.583|-14.187||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.|
1624072|NCT02260986|2981954|Superiority||LS mean difference|-32.1|||<|0.0001|2-Sided|95.0|-46.37|-17.82||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.|
1624073|NCT02260986|2981955|Superiority||LS mean difference|-1.81|||<|0.0001|2-Sided|95.0|-2.297|-1.322||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.|
1624074|NCT02260986|2981956|Superiority||difference in percentages|5.5||||0.0344|2-Sided|95.0|0.56|10.51||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.|
1624075|NCT02260986|2981956|Superiority||difference in percentages|9.6||||0.0062|2-Sided|95.0|1.61|17.63||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.|
1624076|NCT02260986|2981957|Superiority||difference in percentages|10.7||||0.0021|2-Sided|95.0|4.15|17.31||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.|
1624077|NCT02260986|2981957|Superiority||difference in percentages|20.9|||<|0.0001|2-Sided|95.0|10.59|31.15||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.|
1624078|NCT02260986|2981958|Superiority||difference in percentages|27.7|||<|0.0001|2-Sided|95.0|20.65|34.7||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.|
1624079|NCT02260986|2981958|Superiority||difference in percentages|37.9|||<|0.0001|2-Sided|95.0|27.34|48.4||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 24 were considered as non-responders.|
1624080|NCT02260986|2981959|Superiority||difference in percentages|27.3|||<|0.0001|2-Sided|95.0|19.81|34.76||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.|
1624081|NCT02260986|2981959|Superiority||difference in percentages|40.1|||<|0.0001|2-Sided|95.0|28.76|51.35||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.|
1624082|NCT02260986|2981960|Superiority||difference in percentages|26.1|||<|0.0001|2-Sided|95.0|18.76|33.45||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.|
1624124|NCT02260882|2981992|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||Serotype 23F. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.|
1624226|NCT02254408|2982492|Superiority|||||||0.15|||||||Fisher Exact||||
1624083|NCT02260986|2981960|Superiority||difference in percentages|38.3|||<|0.0001|2-Sided|95.0|26.96|49.66||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 52 were considered as non-responders.|
1624084|NCT02260986|2981961|Superiority||LS mean difference|-26.8|||<|0.0001|2-Sided|95.0|-32.83|-20.73||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.|
1624085|NCT02260986|2981961|Superiority||Least square (LS) mean difference|-26.2|||<|0.0001|2-Sided|95.0|-35.04|-17.43||Threshold for significance at 0.025 level.|ANCOVA||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with baseline measurements as covariate and the treatment, region and baseline IGA strata as fixed factors.|
1624086|NCT02260986|2981962|Superiority||difference in percentages|42.5|||<|0.0001|2-Sided|95.0|34.91|50.06||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.|
1624087|NCT02260986|2981962|Superiority||difference in percentages|43.6|||<|0.0001|2-Sided|95.0|32.5|54.65||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 52 were considered as non-responders.|
1624088|NCT02260986|2981963|Superiority||difference in percentages|27.5|||<|0.0001|2-Sided|95.0|20.42|34.58||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.|
1624089|NCT02260986|2981963|Superiority||difference in percentages|23.5|||<|0.0001|2-Sided|95.0|12.72|34.19||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 52 were considered as non-responders.|
1624090|NCT02260986|2981964|Superiority||difference in percentages|34.7|||<|0.0001|2-Sided|95.0|27.31|42.05||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|
1624091|NCT02260986|2981964|Superiority||difference in percentages|37.9|||<|0.0001|2-Sided|95.0|27.56|48.31||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|
1624092|NCT02260986|2981965|Superiority||difference in percentages|31.1|||<|0.0001|2-Sided|95.0|23.84|38.39||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|
1624093|NCT02260986|2981965|Superiority||difference in percentages|39.1|||<|0.0001|2-Sided|95.0|28.53|49.65||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|
1624094|NCT02260986|2981966|Superiority|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|difference in percentages|40.8|||<|0.0001|2-Sided|95.0|33.74|47.81||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level for both comparisons.|
1624227|NCT02254408|2982492|Superiority||Odds Ratio (OR)|0.5||||0.11|2-Sided|95.0|0.22|1.18|||Cochran-Mantel-Haenszel||||
1624095|NCT02260986|2981966|Superiority|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|difference in percentages|45.7|||<|0.0001|2-Sided|95.0|35.72|55.66||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.025 level for both comparisons.|
1624096|NCT02260986|2981967|Superiority||difference in percentages|26.8|||<|0.0001|2-Sided|95.0|20.33|33.28||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg qw v Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.|
1624097|NCT02260986|2981967|Superiority||difference in percentages|26.3|||<|0.0001|2-Sided|95.0|16.34|36.26||Threshold for significance at 0.025 level.|Cochran-Mantel-Haenszel||Dupilumab 300 mg q2w v Placebo|Analysis was performed using Cochran-Mantel-Haenszel test stratified by region and baseline disease severity (IGA baseline values: IGA=3 vs IGA=4). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders.|
1624098|NCT02260934|2981970|Superiority|Week 96||||||0.63||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.|
1624099|NCT02260934|2981970|Superiority|Week 48|||||>|0.99||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.|
1624100|NCT02260934|2981970|Superiority|Week 24|||||>|0.2||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.|
1624101|NCT02260934|2981971|Superiority|Week 96||||||0.05||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.|
1624102|NCT02260934|2981971|Superiority|Week 48||||||0.11||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.|
1624103|NCT02260934|2981971|Superiority|Week 24||||||0.08||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.|
1624104|NCT02260934|2981972|Superiority|Week 96||||||0.94||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.|
1624105|NCT02260934|2981972|Superiority|Week 48||||||0.47||||||2 sided test|Regression, Logistic|2 sided test||Treatment group was the independent variable in the logistic regression.|
1624106|NCT02260934|2981972|Superiority|2 sided test||||||0.89||||||2 sided test|Regression, Logistic|||Treatment group was the independent variable in the logistic regression.|
1624107|NCT02260934|2981974|Superiority|2 sided test||||||0.49||||||2 sided test|Fisher Exact|2 sided test||Week 0 to Week 48|
1624108|NCT02260934|2981975|Superiority|2 sided test|||||>|0.99||||||2 sided test|Fisher Exact|2 sided test||Week 0 to Week 24|
1624109|NCT02260934|2981976|Superiority|Treatment group was the independent variable in the logistic regression.||||||0.29||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 96|
1624110|NCT02260934|2981976|Superiority|Treatment group was the independent variable in the logistic regression.||||||0.26||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 48|
1624111|NCT02260934|2981976|Superiority|Treatment group was the independent variable in the logistic regression.||||||0.73||||||2 sided test|Regression, Logistic|2 sided test||Week 0 to Week 24|
1624112|NCT02260934|2981977|Superiority|Treatment group was the independent variable in the logistic regression.||||||0.91||||||2 sided test|Regression, Logistic|2 sided test||Week 96|
1624113|NCT02260934|2981978|Superiority|Treatment group was the independent variable in the logistic regression.||||||0.32|||||||Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 96|
1624114|NCT02260934|2981978|Superiority|Treatment group was the independent variable in the logistic regression.||||||0.37||||||2 sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 48|
1624115|NCT02260934|2981978|Superiority|Treatment group was the independent variable in the logistic regression.||||||0.64||||||2 sided test|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 24 Treatment group was the independent variable in the logistic regression.|
1624116|NCT02260934|2981979|Superiority|Treatment group was the independent variable in the logistic regression.||||||0.65||||||Treatment group was the independent variable in the logistic regression.|Regression, Logistic|2 sided test||Week 48|Treatment group was the independent variable in the logistic regression.
1624117|NCT02260934|2981979|Superiority|Treatment group was the independent variable in the logistic regression.||||||0.66||||||Treatment group was the independent variable in the logistic regression.|Regression, Logistic|2 sided test||Week 24|
1624118|NCT02260934|2981980|Superiority|P-value could not be produced because of zero count in at least one of the treatment arms||||||||||||||||Week 0 to Week 96 The modified intent to treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.|P-value could not be produced because of zero count in at least one of the treatment arms
1624119|NCT02260934|2981980|Superiority|||||||||||||||||Week 0 to Week 48|P-value could not be produced because of zero count in at least one of the treatment arms.
1624120|NCT02260934|2981980|Superiority|P-value could not be produced because of zero count in at least one of the treatment arms.||||||||||||||||Week 0 to Week 24|Treatment group was the independent variable in the logistic regression.
1624121|NCT02260934|2981982|Superiority|||||||0.15||||||Two-sided test.|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 96.|
1624122|NCT02260934|2981982|Superiority|||||||0.25||||||Two-sided test.|Regression, Logistic|Treatment group was the independent variable in the logistic regression.||Week 0 to Week 48|
1624125|NCT02260882|2981992|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||Serotype 6B. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.|
1624126|NCT02260882|2981992|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||Serotype 3. The statistical success criterion for demonstrating greater geometric mean antibody concentrations at 4 weeks postvaccination is that the lower bound of the 2-sided 95% confidence interval in Geometric Mean Fold Rise will be greater than 1 for all 3 serotypes.|
1624127|NCT02260791|2982028|Equivalence|If the 2-sided 95% CI for the difference in DAS28-CRP at Week 24 between FKB327 and Humira fell entirely between −0.6 and +0.6 then FKB327 was considered equivalent to Humira.|Difference in least square mean|0.01|||||2-Sided|95.0|-0.16|0.18||||||The secondary hypothesis involved equivalence of the difference between FKB327 and Humira in DAS28-CRP at Week 24. Based on the repeated measures analysis model, the difference and its 95% CI in the least-squares means (LSMs) for DAS28-CRP at Week 24 between FKB327 and Humira were estimated. If the 95% CI fell entirely between the pre-specified margin (+/- 0.6), then FKB327 was considered equivalent to Humira.|
1624128|NCT02260791|2982029|Equivalence|-12% to +15% equivalence margin using 90% CI around the difference in ACR20 response rate|Mean Difference (Final Values)|-1.8|||||2-Sided|90.0|-7.3|3.6||||||The difference and its 90% Confidence Interval (CI) for primary endpoint between FKB327 and Humira were estimated. If the 90% CI fell entirely between pre-specified equivalence margin (-12% to +15%), then FKB327 was considered equivalent to Humira.|
1624129|NCT02260492|2982056|Equivalence|Standard bioequivalence 90% confidence bounds set at 0.8-1.25.|Test/Reference|1.0475|||<|0.05|2-Sided|90.0|0.8|1.25|||ANOVA|||Same as the Day 1 analyses|"Week 4 superiority to placebo:~Solis vs. Placebo p=0.019 Advair vs. Placebo p=0.035"
1624130|NCT02260492|2982057|Equivalence|"Equivalence test compares the Test/Reference with confidence bounds set at standard 80-125%.~Superiority test compares Test with Placebo (p<0.05) Superiority test compares Reference with Placebo (p<0.05) (p<0.05)"|Test/Reference|1.0799|||<|0.05|2-Sided|90.0|0.8|1.25|||ANCOVA|||"Primary analyses were conducted on BL subtracted values (pre-dose - post-dose). The two one-sided tests method of interval analysis is standard for bioequivalence testing and employs 2 sets of one-sided hypotheses as follows, performed at the 5% alpha level:~H01: uT-uR < -0.20 uR vs. Ha1: -0.20 uR </= uT- uR (the lower tail) and H02: uT-uR >0.25 uR vs. Ha2: uT- uR </=0.25 uR (the upper tail) When uT is the LSM SOLIS, uR is the LSM of ADVAIR DISKUS"|"Day 1 superiority to placebo:~Solis vs. Placebo p=0.004 Advair vs. Placebo p=0.012"
1624131|NCT02260180|2982068|Other|||||||0.0001||||||not adjusted for multiple observations|ANCOVA||||
1624132|NCT02260180|2982068|Other|||||||0.0001||||||not adjusted for multiple observations|ANCOVA||||
1624133|NCT02260180|2982069|Other|||||||0.001|||||||ANOVA||||
1624134|NCT02260180|2982069|Other|||||||0.001||||||not adjusted for multiple comparisons|ANOVA||||
1624135|NCT02259699|2982082|Superiority|||||||0.745|||||||t-test, 2 sided|||Difference between arms at T4|
1624136|NCT02259699|2982082|Superiority|||||||0.177|||||||t-test, 2 sided|||Difference between arms at T3|
1624137|NCT02259699|2982083|Superiority|||||||0.332|||||||t-test, 2 sided|||Difference between arms at T4|
1624138|NCT02259699|2982083|Superiority|||||||0.071|||||||t-test, 2 sided|||Difference between arms at T3|
1624139|NCT02259699|2982084|Superiority|||||||0.807|||||||t-test, 2 sided||||
1624140|NCT02259699|2982085|Superiority|||||||0.91|||||||t-test, 2 sided|||Difference between arms at T4|
1624141|NCT02259699|2982085|Superiority|||||||0.087|||||||t-test, 2 sided|||Difference between arms at T3|
1624142|NCT02259699|2982086|Superiority|||||||0.288|||||||t-test, 2 sided|||Difference between arms at T4|
1624143|NCT02259699|2982086|Superiority|||||||0.053|||||||t-test, 2 sided|||Difference between arms at T3|
1624144|NCT02259699|2982086|Superiority|||||||0.582|||||||t-test, 2 sided|||Difference between arms at T1|
1624145|NCT02259582|2982089|Superiority|Based on RECIST v1.1. Response outcomes from an assessment done anytime less than Day 35 were considered as not evaluable unless the response assessment was progress disease.|Hazard Ratio (HR)|0.04|||=|0|2-Sided|95.0|0.013|0.095|||Log Rank|||The Kaplan-Meier method was used to estimate both the survival curves and the median survival time. The 95% confidence interval (CI) for the median survival time was calculated. A p-value for treatment effect was generated using a stratified Cox proportional hazards model.|
1624146|NCT02259400|2982103|Non-Inferiority or Equivalence|For the calculation of sample size we used the duration of ventilation as the main primary outcome. As no basic data are available for this population, we were able to retrieve from the database of our two NICUs the duration of ventilation on NIV. We assumed a difference of 24-h between the two groups in the duration of NIV as clinically relevant. We used a confidence level α=0.05; the power level desired was 0.80 and consequently we needed 62 patients for each group.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1624147|NCT02259088|2982143|Superiority or Other||Least Squares Mean Difference|5.8|||<|0.001|2-Sided|95.0|4.1|7.5|||Cochran-Mantel-Haenszel|One-sided p-value for treatment difference is derived from the two-sided stratified Cochran-Mantel-Haenszel test using the row means score statistics.|Estimated from ANOVA (stratified) model. Stratified analysis includes DME type (focal, diffuse, honeycomb and petaloid) and Baseline BCVA(≤ 60 letters and > 60 letters) as factors.||
1624148|NCT02259010|2982154|Superiority or Other (legacy)||Least Squares Mean Ratio|1.39|||||2-Sided|90.0|0.99|1.95|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.||
1624149|NCT02259010|2982155|Superiority or Other (legacy)||Least Squares Mean Ratio|1.35|||||2-Sided|90.0|1.02|1.79|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.||
1624150|NCT02259010|2982156|Superiority or Other (legacy)||Least Squares Mean Ratio|0.98|||||2-Sided|90.0|0.82|1.19|||||Estimates were obtained using a mixed effects model of log (PK parameter) with fixed terms for the itraconazole effect and random terms for participant within period.||
1624151|NCT02257970|2982243|Equivalence|Pre-to-Post comparison: The likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P<0.05|||||=|0|||||||t-test, 2 sided|paired t-test|||
1624152|NCT02257970|2982243|Equivalence|Pre-to-post comparison: the likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P<0.05|||||=|0|||||||t-test, 2 sided|Paired t-test|||
1624153|NCT02257970|2982244|Equivalence|The likelihood of rejecting the null hypothesis (equivalence between the two groups) was defined as P<0.05|||||<|0.0001|||||||t-test, 2 sided|paired t-test||For the analysis, the 4-month post-minus-pre change in this score for ketoprofen was compared.|
1624154|NCT02257632|2982267|Superiority||Mean Difference (Final Values)|-11.46|||<|0.0001|2-Sided|95.0|-15.98|-6.94||missing Baseline VEGF-A level covariate values were imputed by the mean value of non-missing Baseline VEGF-A level from all the patients with values|ANCOVA|including treatment group and center as fixed effect factors and Baseline VEGF-A as a covariate|||
1624155|NCT02257632|2982268|Superiority||Mean Difference (Final Values)|-14.98|||<|0.0001|2-Sided|95.0|-19.64|-10.32||missing Baseline VEGF-A level covariate values were imputed by the mean value of non-missing Baseline VEGF-A level from all other patients|ANCOVA|including treatment group and center as fixed effect factors and Baseline VEGF-A as a covariate|||
1624156|NCT02257385|2982276|Superiority or Other||Least Squares Mean Difference|-0.023||||0.145|2-Sided|95.0|-0.054|0.008|||Mixed Models Analysis||||
1624157|NCT02257385|2982277|Non-Inferiority or Equivalence|Alternate hypothesis:the difference between the trt means (umeclidinium/vilanterol minus indacaterol + tiotropium bromide) would be > -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium/vilanterol may be deemed statistically non-inferior to indacaterol plus tiotropium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, statistical superiority would have been established.|Least Squares Mean Difference|0.001||||0.964|2-Sided|95.0|-0.029|0.03|||Mixed Models Analysis||||
1624158|NCT02257372|2982278|Superiority or Other||Mean Difference (Final Values)|0.148|||<|0.001|2-Sided|95.0|0.099|0.197|||Mixed model repeated measures analysis||||
1624159|NCT02257372|2982279|Superiority or Other||Mean Difference (Final Values)|0.123|||<|0.001|2-Sided|95.0|0.071|0.174|||Mixed model repeated measures analysis||||
1624160|NCT02256917|2982298|Other|A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean ABR in patients with 2x/week prophylaxis or less with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|ABR|5.03|||||2-Sided|95.0|3.9|6.39|||||A confidence interval of 97.5% for confirmative analysis was also used - the respective upper and lower limit CIs were 3.76–6.60||
1624161|NCT02256917|2982299|Other|A respective confirmative one-sided one-sample Poisson-test was used to demonstrate if the mean spontaneous ABR in patients with individually tailored prophylaxis is at least 50% below the mean ABR rate in the GENA-01 trial.|ABR|3.12|||||2-Sided|95.0|2.48|3.87|||||||
1624162|NCT02256917|2982300|Other|Reduction of the annualized total bleeding rate (ABR) observed in the GENA-01 study vs. GENA-21B analyzed with a Poisson regression model including a correction for overdispersion.|Rate ratio|10.14|||<|0.0001|2-Sided|95.0|6.12|16.8|||Poisson regression model||||
1624163|NCT02256917|2982300|Other|Reduction of the annualized total bleeding rate (ABR) observed in the GENA-01 study vs. GENA-21B analyzed with a Negative Binomial regression model including a correction for overdispersion.|Rate ratio|11.89|||<|0.0001|2-Sided|95.0|7.5|18.86|||Negative binomial regression model||||
1624164|NCT02256917|2982300|Other|Confirmative one-sided one-sample Poisson-test.|ABR|4.87|||<||2-Sided|95.0|4.06|5.79|||||A confidence interval of 97.5% for confirmative analysis was also used - the respective upper and lower limit CIs were 3.96-5.93||
1624165|NCT02256839|2982311|Equivalence|A 2x2 contingency table with 95% CI|2 x 2 contingency table|96.1|||||2-Sided|95.0|85.4|99.3|||||||
1624166|NCT02256839|2982311|Equivalence|A 2x2 contingency table with 95% CI.|2 x 2 contingency table|98.1|||||2-Sided|95.0|95.3|99.3|||||||
1624167|NCT02256488|2982322|Non-Inferiority or Equivalence|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) > -0.176 and (μlot A - μlot B) < 0.176 and (μlot A - μlot C) > -0.176 and (μlot A - μlot C) < 0.176 and (μlot B - μlot C) > -0.176 and (μlot B - μlot C) < 0.176"|Ratio of GMTs|1.12|||||2-Sided|95.0|0.667|1.5||||||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22|
1624168|NCT02256488|2982322|Non-Inferiority or Equivalence|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) > -0.176 and (μlot A - μlot B) < 0.176 and (μlot A - μlot C) > -0.176 and (μlot A - μlot C) < 0.176 and (μlot B - μlot C) > -0.176 and (μlot B - μlot C) < 0.176"|Ratio of GMTs|1.02|||||2-Sided|95.0|0.667|1.5||||||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for for all 3 influenza strains at day 22|
1624169|NCT02256488|2982322|Non-Inferiority or Equivalence|"The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:~(μlot A - μlot B) > -0.176 and (μlot A - μlot B) < 0.176 and (μlot A - μlot C) > -0.176 and (μlot A - μlot C) < 0.176 and (μlot B - μlot C) > -0.176 and (μlot B - μlot C) < 0.176"|Ratio of GMTs|0.9|||||2-Sided|95.0|0.667|1.5||||||To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22.|
1624170|NCT02256436|2982328|Superiority or Other (legacy)||Difference in Percentages|13.4||||2e-05|2-Sided|95.0|7.0|19.9||One-sided p-value for testing H0: difference in %=0; H1: difference in %>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||All Participants|
1624171|NCT02256436|2982329|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.16411|2-Sided|95.0|0.74|1.11||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS per Modified RECIST - All Participants|
1624206|NCT02255097|2982450|Superiority or Other (legacy)||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p > 0.05|||
1624207|NCT02255097|2982451|Superiority or Other (legacy)||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p > 0.05|||
1624172|NCT02256436|2982330|Superiority or Other (legacy)||Difference in Percentages|16.9||||0.00022|2-Sided|95.0|7.7|27.0||One-sided p-value for testing H0: difference in %=0; H1: difference in %>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - PD-L1 Positive Participants|
1624173|NCT02256436|2982331|Superiority or Other (legacy)||Difference in Percentages|19.3||||0.0002|2-Sided|95.0|8.6|31.7||One-sided p-value for testing H0: difference in %=0; H1: difference in %>0|Miettinen & Nurminen method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - Strongly PD-L1 Positive Participants|
1624174|NCT02256436|2982332|Superiority or Other (legacy)||Difference in Percentages|9.6||||0.00106|2-Sided|95.0|3.5|15.9||One-sided p-value for testing H0: difference in %=0; H1: difference in %>0|Miettinen & Nurminene method|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||ORR per RECIST 1.1 - All Participants|
1624175|NCT02256436|2982333|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.26443|2-Sided|95.0|0.68|1.24||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - PD-L1 positive participants|
1624176|NCT02256436|2982334|Superiority or Other (legacy)||Hazard Ratio (HR)|0.61||||0.00239|2-Sided|95.0|0.43|0.86||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - PD-L1 positive participants|
1624177|NCT02256436|2982335|Superiority or Other (legacy)||Hazard Ratio (HR)|0.89||||0.23958|2-Sided|95.0|0.61|1.28||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - Strongly PD-L1 positive participants|
1624178|NCT02256436|2982336|Superiority or Other (legacy)||Hazard Ratio (HR)|0.57||||0.00483|2-Sided|95.0|0.37|0.88||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - Strongly PD-L1 positive participants|
1624179|NCT02256436|2982337|Superiority or Other (legacy)||Hazard Ratio (HR)|0.98||||0.41648|2-Sided|95.0|0.81|1.19||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||PFS - All Participants|
1624180|NCT02256436|2982338|Superiority or Other (legacy)||Hazard Ratio (HR)|0.73||||0.00224|2-Sided|95.0|0.59|0.91||One-sided p-value based on stratified log-rank test|Regression, Cox|Treatment as a covariate stratified by ECOG PS, presence/absence of liver metastases, hemoglobin and time from completion of most recent chemotherapy||OS - All Participants (Note: ECOG PS=Eastern Cooperative Oncology Group Performance Status)|
1624181|NCT02256267|2982344|Superiority or Other||Ratio of Geometric Least Squares Means|0.0467|||||2-Sided|90.0|0.0376|0.0581|||||||
1624182|NCT02256267|2982345|Superiority or Other||Ratio of Geometric Least Squares Means|0.0771|||||2-Sided|90.0|0.0671|0.0886|||||||
1624183|NCT02256072|2982363|Superiority or Other||Slope|0.22|Standard Error of the Mean|0.05|<|0.0001|2-Sided|||||p-value controlled for significant baseline covariates (sex, income, health literacy, education level, high blood pressure, and kidney disease) and individual participant effect.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.||Compared to participants in the attention control group, participants receiving PLAN YOUR LIFESPAN will show increased UHS 1 (efficacy) and 3 (effect retention) months post-intervention. Secondary analyses will compare baseline variables with outcome (one-at-a-time). Those with a significant association with outcome will be included in a LMM for UHS, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for UHS.|
1624184|NCT02256072|2982364|Superiority or Other||Slope|0.075|Standard Error of the Mean|0.094||0.423|2-Sided|||||p-value controlled for significant baseline covariates (confidence in using the internet, self efficacy score, support score, and race/ethnicity.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.|The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, with a total possible range of 5-25. No subscores are calculated.|H2: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased confidence in accessing home services (measured via the Confidence in Accessing Home Services tool) one (efficacy) and three (effect retention) months after intervention.|
1624185|NCT02256072|2982365|Superiority or Other||Slope|0.244|Standard Error of the Mean|0.123||0.0471|2-Sided|||||P-value controlled for significant baseline covariates (sex, importance of religion, stroke, and self efficacy score) and individual participant effect.|Mixed Models Analysis|The p-value is based on the slope estimation provided below.||Secondary analyses will compare baseline variables (current utilization of services, physical function assessment, co-morbidities, social support, health literacy, self-efficacy, and sociodemographics) with outcome (one-at-a-time). Those found to have a significant association with outcome will be included in a linear mixed model, with random effect for intercept. A backward stepwise model building process will be used to determine an overall parsimonious model for outcome.|
1624186|NCT02256072|2982366|Superiority or Other||Slope|1.25|Standard Error of the Mean|0.45||0.0054|2-Sided|95.0|0.37|2.12|||ANCOVA|||H1: Compared to participants in the attention control group and controlling for baseline assessments, participants receiving the PLAN YOUR LIFESPAN tool will show increased planning with regard to planning behavior score (measured via the Planning Assessment tool) one (efficacy) month after intervention.|
1624208|NCT02255097|2982452|Superiority or Other (legacy)||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p > 0.05|||
1624209|NCT02255097|2982453|Superiority or Other (legacy)|||||||0.0027|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p > 0.05|||
1624210|NCT02255097|2982454|Superiority or Other (legacy)||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p > 0.05|||
1624211|NCT02255097|2982457|Superiority or Other (legacy)||||||<|0.001|||||||exact binomial distribution|H0: p ≤ 0.05 versus H1: p > 0.05|||
1624187|NCT02255981|2982370|Other|Non-inferiority could be considered if the outcomes were comparable to the most known studies yet published or, in the case of non-treatable disorder, if the acupuncture treatment got to maintain the VA and prevent the losses. There are many known studies with conventional treatment and estimations of the worsening of vision in this pathologies on the time without treatment.|Mean Difference (Final Values)|15.392|||<|0.05|2-Sided|95.0||||"Using the SPSS program and the non-parametrical technic of Wilcoxon it was determined the p-value.~It should be noted that the null hypothesis is that all these eyes should have a zero gain or perhaps a loss in VA at two years of follow-up."|t-test, 1 sided|From this estimation, it is induced that there are differences in results before and after the treatment.|The datum corresponds to the difference in letters seen between exams at the start and the final examination for all participants. Calculi were made by a Microsoft Excel Descriptive Statistics program.|"Besides that it is of interest to compare with the published studies outcomes, realized with anti-VEGF treatments, and with the known expectations of AV lost without treatment, the data were converted in letters ETDRS chart and here are registered the mean number of letters gained or lost in each group.~Ho: Differences between mean measurements before and after are similar H1: Differences between mean measurements before and after are different."|The null hypothesis was no gain or loss in VA. The alternative hypothesis was stabilization or some gain in letters seen over the baseline count.The published studies report a small gain in VA in about a third of participants and only in cases of NV-AMD with conventional treatment, and an expectancy of loss of vision in the other non treated or non-treatable macular diseases. Some of the participants in this trial had had ocular injections without positive change. Non-inferiority in this trial means outcomes of similar magnitude to the known studies.
1624188|NCT02255461|2982394|Other|Ordinal logistic regression model was built for outcome leukopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.1|||||2-Sided|95.0|1.01|1.2|||||||
1624189|NCT02255461|2982395|Other|Ordinal logistic regression model was built for outcome lymphopenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.05|||||2-Sided|95.0|0.97|1.15|||||||
1624190|NCT02255461|2982396|Other|Ordinal logistic regression model was built for outcome neutropenia (0/1/2). Explanatory variable AUC was transformed by dividing by 100.|Odds Ratio (OR)|1.06|||||2-Sided|95.0|0.97|1.15|||||||
1624191|NCT02255279|2982414|Non-Inferiority or Equivalence|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 > πi2-0.1 vs. H1i: πi1 > πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|58.0|||||2-Sided|95.0|47.5|68.5||||||Percentage of subjects achieving seroconversion in B strains after last vaccination with aTIV or TIV in naïve and non naive subjects.|
1624192|NCT02255279|2982414|Non-Inferiority or Equivalence|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 > πi2-0.1 vs. H1i: πi1 > πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|10.0|||||2-Sided|95.0|-1.8|21.0||||||Percentage of subjects achieving seroconversion in H3N2 strain after last vaccination with aTIV or TIV in naive and non-naive subjects.|
1624193|NCT02255279|2982414|Non-Inferiority or Equivalence|"The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:~H0i: πi1 > πi2-0.1 vs. H1i: πi1 > πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%)."|Vaccine Group Differences|17.0|||||2-Sided|95.0|8.1|26.3||||||Percentage of subjects achieving seroconversion in H1N1 strain after last vaccination with aTIV or TIV in naïve and non-naive subjects.|
1624194|NCT02255279|2982415|Non-Inferiority or Equivalence|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi >-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV & TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is >0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|4.67|||||2-Sided|95.0|3.52|6.2||||||Geometric mean titers (GMTs), in B strain of all three homologous virus strains in Subjects 6 to < 72 months of Age.|
1624195|NCT02255279|2982415|Non-Inferiority or Equivalence|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi >-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV & TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is >0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|2.58|||||2-Sided|95.0|2.05|3.25||||||Geometric mean titers (GMTs), in H3N2 strain of all three homologous virus strains in Subjects 6 to < 72 months of Age.|
1624196|NCT02255279|2982415|Non-Inferiority or Equivalence|"Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:~H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi – μBi >-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV & TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is >0.67.~Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains."|Ratio of GMTs|4.06|||||2-Sided|95.0|3.0|5.51||||||Geometric mean titers (GMTs), in H1N1 strain of all the tree strains in Subjects 6 to < 72 months of Age.|
1624197|NCT02255175|2982422|Superiority|||||||0.0002|||||||Repeated measures ANOVA|F(1,33)=17.91|||
1624198|NCT02255175|2982423|Superiority|||||||0.831|||||||t-test, 2 sided|t=.216, df=33|||
1624199|NCT02255175|2982424|Superiority|||||||0.486|||||||t-test, 2 sided|t=.705, df=33|||
1624200|NCT02255175|2982425|Superiority|||||||0.015|||||||t-test, 2 sided|t=2.56, df=33|||
1624201|NCT02255175|2982426|Superiority|||||||0.645|||||||t-test, 2 sided|t=.465, df=33|||
1624202|NCT02255175|2982427|Superiority|||||||0.518|||||||t-test, 2 sided|t=.653, df=33|||
1624203|NCT02255175|2982428|Superiority|||||||0.758|||||||t-test, 2 sided|t=-.310, df=33|||
1624204|NCT02255175|2982429|Superiority|||||||0.855|||||||t-test, 2 sided|t=.185, df=33|||
1624205|NCT02255175|2982430|Superiority|||||||0.62|||||||t-test, 2 sided|t=.501, df=33|||
1624213|NCT02254486|2982472|Non-Inferiority or Equivalence|Formal hierarchical testing of this key secondary endpoints was not performed due to the results of the non-inferiority analysis.||||||0.781|||||||Fisher Exact|||If at least one of the alternative primary endpoints were met, then key secondary endpoints were evaluated hierarchichally in a pre-specified order. Non-inferiority was concluded if the 1-sided 97.5% confidence limit (CL) for difference in proportion of events between 2 groups excluded a 10% or greater difference was in favor of Trisulate Solution. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint had at least met non-inferiority.|
1624214|NCT02254486|2982473|Non-Inferiority or Equivalence|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.||||||0.953||||||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in PDR was calculated as NER1006 rate – Trisulfate Solution rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.|
1624215|NCT02254486|2982474|Non-Inferiority or Equivalence|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.||||||0.66||||||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate – TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.|
1624216|NCT02254486|2982475|Non-Inferiority or Equivalence|To be declared non-inferior, the key secondary endpoint must show a difference in rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in ADR|-3.01||||0.863|2-Sided|95.0|-11.36|5.28||To be declared superior, the key secondary endpoint must demonstrate non-inferiority and show a significant advantage for NER1006 relative to Trisulfate Solution with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||If at least one of the alternative primary endpoints was met, then key secondary endpoints for the same colon region as met by the primary endpoint were evaluated hierarchically in a pre-specified order. The difference in ADR was calculated as NER1006 rate – TS rate using 1-sided 97.5% confidence limits. Formal testing was to proceed in the hierarchy if preceding key secondary endpoint met non-inferiority. This procedure ensured overall Type I error control at 2.5% 1-sided.|
1624217|NCT02254486|2982476|Non-Inferiority or Equivalence|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior the primary endpoint must show a difference in success rates of no greater than 10% in favour of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in excellent plus good rate|6.58||||0.059|1-Sided|97.5|-1.69|||P-value was adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, primary endpoint must demonstrate non-inferiority and with 1-sided p-value <0.025; the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|
1624218|NCT02254486|2982477|Non-Inferiority or Equivalence|The confidence limits were adjusted for multiple comparisons (two alternative primary endpoints): To be declared non-inferior, the primary endpoint must show a difference in success rates of no greater than 10% in favor of Trisulfate Solution using lower 1-sided 97.5% confidence limits. Calculated using exact Clopper-Pearson confidence limits.|Difference in success rate|0.14||||0.528|1-Sided|97.5|-8.15|||P-value adjusted for multiple comparisons (two alternative primary endpoints): To be declared superior, the primary endpoint must demonstrate non-inferiority with 1-sided p-value <0.025, the threshold for statistical significance.|Fisher Exact|||The hypothesis was to demonstrate NI of NER1006 to Trisulfate Solution (TS) (10% margin). Success rate was number of patients with successful overall bowel cleansing as proportion of number of patients in each group. Treatment effect was NER1006 success rate - TS success rate. A Hochberg procedure was used to control Type I error since there were 2 alternative primary endpoints. An alpha level of 1.25% 1-sided was used. A closed testing procedure used to evaluate superiority if NI was met.|
1624219|NCT02254460|2982486|Superiority or Other||[Treatment difference]|1.74||||0.0944|2-Sided|95.0|0.9|3.34|||ANOVA||Treatment difference from ANOVA of log transformed data. Back transformed data are presented. This therefore represents the iron absorption ratio of the Micronutrient Fortified Drink (Test) to the Non-Fortified Drink (Control).||
1624220|NCT02254421|2982487|Superiority|||||||0.19||||||P-value was calculated from the CMH test stratified by stratification factors.|Cochran-Mantel-Haenszel||||
1624221|NCT02254421|2982488|Superiority|||||||0.98||||||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) test stratified by stratification factors.|Cochran-Mantel-Haenszel||||
1624222|NCT02254421|2982489|Superiority|||||||0.84||||||P-value was calculated from the negative binomial model with stratification factors as covariates.|Negative binomial||||
1624223|NCT02254421|2982490|Superiority||Treatment difference|-0.02||||0.94|2-Sided|95.0|-0.62|0.57||P-value was calculated from the ANCOVA model including baseline values and stratification factors.|ANCOVA||||
1624224|NCT02254408|2982491|Superiority|||||||1|||||||Fisher Exact||||
1624291|NCT02253173|2982570|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624228|NCT02254408|2982493|Superiority||Treatment Difference|-0.33||||0.04|2-Sided|95.0|-0.64|-0.02|||ANCOVA||||
1624229|NCT02253654|2982544|Superiority or Other||Treatment difference|0.39|Standard Error of the Mean|3.53||0.46|1-Sided|97.5|-6.58||||t-test, 1 sided|||The difference between treatment groups for the percent of hemoglobin measurements within 10.0 to 11.0 g/dL during the evaluation period was tested using a 1-sided t-test with a significance level of 0.025.|
1624230|NCT02253537|2982545|Equivalence|2 x 2 contingency table with 95% CI.|2 x 2 contingency table|86.7|||||2-Sided|95.0|62.1|96.3|||||||
1624231|NCT02253433|2982546|Superiority||Odds Ratio (OR)|0.86||||0.043|2-Sided|95.0|0.47|1.57|||Mixed Models Analysis|ED visits over the previous 12 months were positively skewed (skewness 2.95; kurtosis 14.1); the responses were dichotomized (0 vs. 1 or more).|||
1624232|NCT02253433|2982547|Superiority||Mean Difference (Final Values)|0.25||||0.141|2-Sided|95.0|-0.18|0.68|||Mixed Models Analysis||||
1624233|NCT02253433|2982548|Superiority||Mean Difference (Final Values)|0.6||||0.575|2-Sided|95.0|-0.87|2.07|||Mixed Models Analysis||||
1624234|NCT02253173|2982551|Superiority or Other|||||||0.0073|||||||ANCOVA||||
1624235|NCT02253173|2982551|Superiority or Other|||||||0.3751|||||||ANCOVA||||
1624236|NCT02253173|2982551|Superiority or Other|||||||0.9039|||||||ANCOVA||||
1624237|NCT02253173|2982552|Superiority or Other|||||||0.015|||||||ANCOVA||||
1624238|NCT02253173|2982552|Superiority or Other|||||||0.0099|||||||ANCOVA||||
1624239|NCT02253173|2982552|Superiority or Other|||||||0.5146|||||||ANCOVA||||
1624240|NCT02253173|2982553|Superiority or Other|||||||0.0898|||||||ANCOVA||||
1624241|NCT02253173|2982553|Superiority or Other|||||||0.9634|||||||ANCOVA||||
1624242|NCT02253173|2982553|Superiority or Other|||||||0.9929|||||||ANCOVA||||
1624243|NCT02253173|2982554|Superiority or Other|||||||0.0003|||||||ANCOVA||||
1624244|NCT02253173|2982554|Superiority or Other|||||||0.0013|||||||ANCOVA||||
1624245|NCT02253173|2982554|Superiority or Other|||||||0.4162|||||||ANCOVA||||
1624246|NCT02253173|2982555|Superiority or Other|||||||0.1189|||||||ANCOVA||||
1624247|NCT02253173|2982555|Superiority or Other|||||||0.2855|||||||ANCOVA||||
1624248|NCT02253173|2982555|Superiority or Other|||||||0.9999|||||||ANCOVA||||
1624249|NCT02253173|2982556|Superiority or Other|||||||0.0085|||||||ANCOVA||||
1624250|NCT02253173|2982556|Superiority or Other|||||||0.0614|||||||ANCOVA||||
1624251|NCT02253173|2982556|Superiority or Other|||||||0.9719|||||||ANCOVA||||
1624252|NCT02253173|2982557|Superiority or Other|||||||0.0019|||||||ANCOVA||||
1624253|NCT02253173|2982557|Superiority or Other|||||||0.0492|||||||ANCOVA||||
1624254|NCT02253173|2982557|Superiority or Other|||||||0.9075|||||||ANCOVA||||
1624255|NCT02253173|2982558|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624256|NCT02253173|2982558|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624257|NCT02253173|2982558|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624258|NCT02253173|2982559|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624259|NCT02253173|2982559|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624260|NCT02253173|2982559|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624261|NCT02253173|2982560|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624262|NCT02253173|2982560|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624263|NCT02253173|2982560|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624264|NCT02253173|2982561|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624265|NCT02253173|2982561|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624266|NCT02253173|2982561|Superiority or Other||||||<|0.0004|||||||Mixed Models Analysis||||
1624267|NCT02253173|2982562|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624268|NCT02253173|2982562|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624269|NCT02253173|2982562|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624270|NCT02253173|2982563|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624271|NCT02253173|2982563|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624272|NCT02253173|2982563|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624273|NCT02253173|2982564|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624274|NCT02253173|2982564|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624275|NCT02253173|2982564|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624276|NCT02253173|2982565|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624277|NCT02253173|2982565|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624278|NCT02253173|2982565|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624279|NCT02253173|2982566|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624280|NCT02253173|2982566|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624281|NCT02253173|2982566|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624282|NCT02253173|2982567|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624283|NCT02253173|2982567|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624284|NCT02253173|2982567|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624285|NCT02253173|2982568|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624286|NCT02253173|2982568|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624287|NCT02253173|2982568|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624288|NCT02253173|2982569|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624289|NCT02253173|2982569|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624290|NCT02253173|2982569|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624292|NCT02253173|2982570|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624293|NCT02253173|2982570|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624294|NCT02253173|2982571|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624295|NCT02253173|2982571|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624296|NCT02253173|2982571|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624297|NCT02253173|2982572|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624298|NCT02253173|2982572|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624299|NCT02253173|2982572|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624300|NCT02253173|2982573|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624301|NCT02253173|2982573|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624302|NCT02253173|2982573|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624303|NCT02253173|2982574|Superiority or Other|||||||0.0263|||||||Mixed Models Analysis||||
1624304|NCT02253173|2982574|Superiority or Other|||||||0.0055|||||||Mixed Models Analysis||||
1624305|NCT02253173|2982574|Superiority or Other|||||||0.0503|||||||Mixed Models Analysis||||
1624306|NCT02253173|2982575|Superiority or Other|||||||0.0914|||||||Mixed Models Analysis||||
1624307|NCT02253173|2982575|Superiority or Other|||||||0.0356|||||||Mixed Models Analysis||||
1624308|NCT02253173|2982575|Superiority or Other|||||||0.0639|||||||Mixed Models Analysis||||
1624309|NCT02253173|2982576|Superiority or Other|||||||0.4118|||||||Mixed Models Analysis||||
1624310|NCT02253173|2982576|Superiority or Other|||||||0.2328|||||||Mixed Models Analysis||||
1624311|NCT02253173|2982576|Superiority or Other|||||||0.7829|||||||Mixed Models Analysis||||
1624312|NCT02253173|2982577|Superiority or Other|||||||0.6518|||||||Mixed Models Analysis||||
1624313|NCT02253173|2982577|Superiority or Other|||||||0.2439|||||||Mixed Models Analysis||||
1624314|NCT02253173|2982577|Superiority or Other|||||||0.9616|||||||Mixed Models Analysis||||
1624315|NCT02253173|2982578|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624316|NCT02253173|2982578|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624317|NCT02253173|2982578|Superiority or Other||||||<|0.0014|||||||Mixed Models Analysis||||
1624318|NCT02253173|2982579|Superiority or Other|||||||0.0008|||||||Mixed Models Analysis||||
1624319|NCT02253173|2982579|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624320|NCT02253173|2982579|Superiority or Other||||||<|0.0128|||||||Mixed Models Analysis||||
1624321|NCT02253173|2982580|Superiority or Other|||||||0.0005|||||||Mixed Models Analysis||||
1624322|NCT02253173|2982580|Superiority or Other|||||||0.0001|||||||Mixed Models Analysis||||
1624323|NCT02253173|2982580|Superiority or Other|||||||0.0094|||||||Mixed Models Analysis||||
1624324|NCT02253173|2982581|Superiority or Other|||||||0.0082|||||||Mixed Models Analysis||||
1624325|NCT02253173|2982581|Superiority or Other|||||||0.0019|||||||Mixed Models Analysis||||
1624326|NCT02253173|2982581|Superiority or Other|||||||0.1269|||||||Mixed Models Analysis||||
1624327|NCT02253173|2982582|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624328|NCT02253173|2982582|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624329|NCT02253173|2982582|Superiority or Other||||||<|0.0003|||||||Mixed Models Analysis||||
1624330|NCT02253173|2982583|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624331|NCT02253173|2982583|Superiority or Other||||||<|0.0009|||||||Mixed Models Analysis||||
1624332|NCT02253173|2982583|Superiority or Other||||||<|0.0069|||||||Mixed Models Analysis||||
1624333|NCT02253173|2982584|Superiority or Other|||||||0.0105|||||||Mixed Models Analysis||||
1624334|NCT02253173|2982584|Superiority or Other|||||||0.0019|||||||Mixed Models Analysis||||
1624335|NCT02253173|2982584|Superiority or Other|||||||0.026|||||||Mixed Models Analysis||||
1624336|NCT02253173|2982585|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624337|NCT02253173|2982585|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624338|NCT02253173|2982585|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624339|NCT02253173|2982586|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624340|NCT02253173|2982586|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624341|NCT02253173|2982586|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624342|NCT02253173|2982587|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624343|NCT02253173|2982587|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624344|NCT02253173|2982587|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624345|NCT02253173|2982588|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624346|NCT02253173|2982588|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624347|NCT02253173|2982588|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624348|NCT02253173|2982589|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624349|NCT02253173|2982589|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624350|NCT02253173|2982589|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624351|NCT02253173|2982590|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624352|NCT02253173|2982590|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624353|NCT02253173|2982590|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624354|NCT02253173|2982591|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624355|NCT02253173|2982591|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624356|NCT02253173|2982591|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624357|NCT02253173|2982592|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624358|NCT02253173|2982592|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624359|NCT02253173|2982592|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624360|NCT02253173|2982593|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624361|NCT02253173|2982593|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624362|NCT02253173|2982593|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624363|NCT02253173|2982594|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624364|NCT02253173|2982594|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624365|NCT02253173|2982594|Superiority or Other||||||<|0.0149|||||||Mixed Models Analysis||||
1624366|NCT02253173|2982595|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624367|NCT02253173|2982595|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624368|NCT02253173|2982595|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624369|NCT02253173|2982596|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624370|NCT02253173|2982596|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624371|NCT02253173|2982596|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624372|NCT02253173|2982597|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624373|NCT02253173|2982597|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624374|NCT02253173|2982597|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1624375|NCT02253147|2982626|Non-Inferiority|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA UD and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.22|||||2-Sided|95.0|-0.34|-0.11|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 95.0% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Ultra Deep versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline."|
1624376|NCT02252965|2982636|Superiority or Other||Percentage difference|-1.52||||0.674|2-Sided|95.0|-8.6|5.56|||Mantel Haenszel||||
1624377|NCT02252965|2982637|Non-Inferiority or Equivalence|The non-inferiority margin of this efficacy outcome measure is -0.4%.|Least Squares (LS) Mean Difference|0.03|||||2-Sided|95.0|-0.1|0.17|||||||
1624378|NCT02252562|2982666|Equivalence|We hypothesized a potential 66% reduction from a baseline incidence of 0.16 on the basis of prior interventions, but we assumed for power considerations a more conservative reduction of 40% from a baseline incidence of 0.12 averaged across all patients in each arm. Assuming a 10% loss to follow-up, we required 1,600 patients per group for a power of 0.9 with a type 1 error of .05.|Odds Ratio (OR)|1.07|||||2-Sided|95.0|0.82|1.4|||||||
1624379|NCT02252172|2982762|Superiority||Hazard Ratio (HR)|0.56|||<|0.0001|2-Sided|95.0|0.43|0.73|||Log Rank||||
1624380|NCT02252042|2982769|Superiority||Hazard Ratio (HR)|1.01||||0.51982|2-Sided|95.0|0.81|1.26|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) & PD-L1 status (Strongly Positive, Not Strongly Positive)||
1624381|NCT02252042|2982770|Superiority||Hazard Ratio (HR)|1.04||||0.65759|2-Sided|95.0|0.86|1.27|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) & PD-L1 status (Strongly Positive, Not Strongly Positive)||
1624382|NCT02252042|2982771|Superiority||Hazard Ratio (HR)|0.81||||0.05851|2-Sided|95.0|0.62|1.06||p-value stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) & PD-L1 status (Strongly Positive, Not Strongly Positive)|Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) & PD-L1 status (Strongly Positive, Not Strongly Positive)||
1624383|NCT02252042|2982772|Superiority||Hazard Ratio (HR)|0.89||||0.14545|2-Sided|95.0|0.7|1.12||p-value stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) & PD-L1 status (Strongly Positive, Not Strongly Positive)|Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) & PD-L1 status (Strongly Positive, Not Strongly Positive)||
1624384|NCT02252042|2982775|Superiority||Difference in percentages|7.5||||0.0171|2-Sided|95.0|0.6|14.6|||Log Rank|H0: difference in %=0; H1: difference in %>0|Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) & PD-L1 status (Strongly Positive, Not Strongly Positive)||
1624385|NCT02252042|2982776|Superiority||Difference in percentages|4.6||||0.061|2-Sided|95.0|-1.2|10.6|||Log Rank|H0: difference in %=0; H1: difference in %>0|Stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) & PD-L1 status (Strongly Positive, Not Strongly Positive)||
1624386|NCT02252042|2982777|Superiority||Hazard Ratio (HR)|0.86||||0.07736|2-Sided|95.0|0.69|1.06|||Log Rank||Cox regression model with treatment as a single covariate||
1624387|NCT02252042|2982778|Superiority||Hazard Ratio (HR)|0.96||||0.32504|2-Sided|95.0|0.79|1.16|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) & PD-L1 status (Strongly Positive, Not Strongly Positive)||
1624388|NCT02252042|2982779|Superiority||Hazard Ratio (HR)|0.74||||0.00493|2-Sided|95.0|0.58|0.93|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) & PD-L1 status (Strongly Positive, Not Strongly Positive)||
1624389|NCT02252042|2982780|Superiority||Hazard Ratio (HR)|0.8||||0.01605|2-Sided|95.0|0.65|0.98||Nominal p-value|Log Rank||Nominal HR. Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) & PD-L1 status (Strongly Positive, Not Strongly Positive)||
1624390|NCT02252042|2982781|Superiority||Hazard Ratio (HR)|0.82||||0.0316|2-Sided|95.0|0.67|1.01|||Log Rank||Cox regression model with treatment as a covariate stratified by ECOG PS (0 vs. 1), HPV status (Positive vs. Negative) & PD-L1 status (Strongly Positive, Not Strongly Positive)||
1624391|NCT02252016|2982783|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.155|2-Sided|95.0|-10.2|1.6|||Miettinen & Nurminen method|||The estimated difference (± 95% CI) in percentage of participants withdrawing from study treatment due to an AE(s) in the Immediate versus Deferred arms was determined.|
1624392|NCT02252016|2982784|Superiority or Other||Mean Difference (Final Values)|7.5|||||2-Sided|95.0|-7.3|23.3||||||The estimated difference (± 95% confidence interval [CI]) in percentage of participants experiencing an AE in the Immediate versus Deferred arms was determined.|
1624393|NCT02251990|2982788|Superiority or Other||Difference in Percentages|-0.5|||||2-Sided|95.0|-4.2|0.9||||||Estimates and 95% CIs were calculated for between-treatment differences (ITG minus DTG) in the percentage of participants with events using the Miettinen and Nurminen method.|
1624394|NCT02251990|2982789|Superiority or Other||Difference in Percentages|-0.5|||||2-Sided|95.0|-10.6|9.6||||||Estimates and 95% CIs were calculated for between-treatment differences (ITG minus DTG) in the percentage of participants with events using the Miettinen and Nurminen method.|
1624395|NCT02251990|2982790|Superiority or Other||||||<|0.001||||||The p-value was based on a one-sided asymptotic test for a binomial proportion. A one-sided p-value <0.0125 was considered supportive of a conclusion that the true SVR12 is >73%.|one-sided asymptotic test|||A one-sided Wald test was used to test the null hypothesis, which was that the SVR12 rate for the ITG was ≤ the historical reference rate of 73%. The historical reference SVR rate for treatment-naive genotype 1 predominantly Asian participants treated with pegylated interferon/ribavirin was derived from 2 studies (PMCID: PMC417, PMCID: PMC3644280) after adjusting for an expected improved safety profile related to an interferon-free regimen.|
1624396|NCT02251886|2982802|Superiority or Other||Risk Ratio (RR)|1.0||||1|2-Sided|95.0|0.69|1.46|||Chi-squared||||
1624397|NCT02251886|2982802|Superiority or Other||Risk Ratio (RR)|1.17||||0.48|2-Sided|95.0|0.77|1.76|||Chi-squared||||
1624398|NCT02250703|2982846|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1624399|NCT02250703|2982847|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1624400|NCT02250703|2982848|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1624401|NCT02250703|2982849|Superiority or Other|||||||0.025||||||Difference in proportions in satisfactory sedation on separation from parents and on induction between M and D groups (Primary Outcome variables)|Chi-squared|||A sample size of at least 33 patients in each group would detect at least 30% difference in proportion of children who achieve satisfactory sedation between the M and D groups at 0.05 level of significance and 80% power|
1624402|NCT02250326|2982881|Superiority||Hazard Ratio (HR)|1.7|||||2-Sided|95.0|1.08|2.57||||||Based on stratified Cox proportional hazards regression model.|
1624403|NCT02250326|2982882|Superiority||Overall Response Rate Ratio|0.84|||||2-Sided|95.0|0.398|1.754|||||95% CI was calculated using Clopper-Pearson method.||Direction of Overall Response Rate Ratio is ORR of Nab-Paclitaxel + CC-486 Combination Arm over ORR of nab-Paclitaxel Alone.
1624404|NCT02250326|2982883|Superiority||Disease Control Rate Ratio|0.97|||||2-Sided|95.0|0.778|1.207|||||95% CI was calculated using Clopper-Pearson method.||Direction of Disease Control Rate Ratio is DCR of Nab-Paclitaxel + CC-486 Combination Arm over DCR of Nab-Paclitaxel Alone
1624405|NCT02250326|2982884|Superiority||Hazard Ratio (HR)|1.3|||||2-Sided|95.0|0.9|1.94||||||Based on stratified Cox proportional hazards regression model.|
1624406|NCT02250183|2982890|Superiority||Mean Difference (Final Values)|3.615|Standard Error of the Mean|0.79||0.003|2-Sided|95.0|1.149|4.565||The null hypothesis was that the two mean scores would not differ significantly at p<.05 level.|t-test, 2 sided|df = 13||A paired samples, 2-tailed, t-test was used to compare means within participants for ratings of MEDIHONEY and SANTYL satisfaction total scores. The null hypothesis was that the two mean scores would not differ significantly at p<.05 level.|
1624407|NCT02250183|2982891|Superiority||Odds Ratio (OR)|1.0||||1|2-Sided|||||A priori threshold for statistical significance was p<0.05. Each case (participant) serves as its own control because they received both treatment modalities simultaneously.|McNemar|McNemar test was used because participants received both treatments, so this variable was non-independent in our single group sample.|2-sided|Each participant received both treatment modalities - MEDIHONEY® and SANTYL - and thus had two wound cultures performed, one for each treatment modality. This was a single group study; however, wound culture results were contrasted with each other across participants. Thus, independent variable was treatment modality, while dependent variable was the wound culture result (positive for presence of bacteria versus negative for absence of bacteria).|
1624408|NCT02249832|2982897|Equivalence|A 3x3 repeated measures ANOVA was performed with group (mean distance walked in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).||||||0.001||||||A significance level of 0.05 was used (two-sided).|ANOVA||||
1624409|NCT02249832|2982898|Equivalence|A significance level of 0.05 was used (two-sided).|||||<|0.001|||||||ANOVA|||A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).|
1624410|NCT02249832|2982899|Equivalence|A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).|||||<|0.001||||||A significance level of 0.05 was used (two-sided).|ANOVA||||
1624445|NCT02248974|2983016|Superiority|||||||0.99|||||||Wilcoxon (Mann-Whitney)||||
1624446|NCT02248974|2983017|Superiority|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.|
1625445|NCT02223364|2985264|Superiority|||||||0.299|||||||Wilcoxon (Mann-Whitney)||||
1624411|NCT02249819|2982900|Equivalence|Statistical analysis for mean change from baseline in naming accuracy in the anodal vs. sham tDCS conditions Null hypothesis is that there was no difference in mean change of naming accuracy between anodal and sham tDCS conditions. A significance level of 0.05 was used (two-sided).||||||0.694||||||The wilcoxon sign-ranked test was performed for this crossover design study in which subjects underwent measures across 2 study conditions (paired samples: mean change in anodal vs. sham condition). A significance level of 0.05 was used (two-sided).|wilcoxon sign-ranked test|Western Aphasia Battery used as a screening tool on admission only, to characterize level of severity. It was NOT an outcome measure.|||
1624412|NCT02249182|2982957|Equivalence|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|187.76|||||2-Sided|90.0|143.41|245.82||||||AUCtau of SOF for the 3 to < 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.|
1624413|NCT02249182|2982957|Equivalence|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|129.48|||||2-Sided|90.0|110.79|151.32||||||AUCtau of SOF for the 6 to < 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.|
1624414|NCT02249182|2982957|Equivalence|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|159.88|||||2-Sided|90.0|137.89|185.37||||||AUCtau of SOF for the 12 to < 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.|
1624415|NCT02249182|2982957|Equivalence|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|120.46|||||2-Sided|90.0|93.18|155.73||||||AUCtau of LDV for the 3 to < 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.|
1624416|NCT02249182|2982957|Equivalence|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|82.25|||||2-Sided|90.0|61.34|110.3||||||AUCtau of LDV for the 6 to < 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.|
1624417|NCT02249182|2982957|Equivalence|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|127.18|||||2-Sided|90.0|94.89|170.45||||||AUCtau of LDV for the 12 to < 18 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.|
1624418|NCT02249182|2982957|Equivalence|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|94.08|||||2-Sided|90.0|82.51|107.27||||||AUCtau of GS-331007 for the 3 to < 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.|
1624419|NCT02249182|2982957|Equivalence|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|65.76|||||2-Sided|90.0|56.62|76.37||||||AUCtau of GS-331007 for the 6 to < 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.|
1624420|NCT02249182|2982957|Equivalence|Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|105.2|||||2-Sided|90.0|90.61|122.13||||||AUCtau of GS-331007 for the 12 to < 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.|
1624421|NCT02249143|2982967|Superiority|||||||||||||||||Group differences in the secondary outcomes were tested at randomization, two weeks, and discharge using independent samples t-tests.|
1624422|NCT02249143|2982967|Superiority||||||>|0.05|||||||t-test, 2 sided||||
1624423|NCT02249143|2982968|Superiority||Mean Difference (Net)|6.62|||<|0.05|2-Sided|95.0|0.02|13.22|||Regression, Linear|||FRC values over time were modeled using linear mixed effects regression with treatment group vs. time interaction and repeated measures for the randomization, 2 week, and discharge time points. Compound symmetric covariance structures were used to account for the correlation of FRC values within each patient. We compared outcomes between the two treatment groups and included adjustments for gender, twin gestation, and weight at randomization.|
1624424|NCT02249052|2982984|Superiority or Other||Binomial proportion|0.8947|||<|0.0001|2-Sided|95.0|0.6686|0.987|||Sign test||||
1624425|NCT02249052|2982985|Superiority or Other||Mean Difference (Final Values)|-83.33|Standard Deviation|25.0311|<|0.0001|2-Sided|95.0|-95.394|-71.265|||t-test, 2 sided||||
1624426|NCT02248974|2982986|Superiority|||||||0.2|||||||Fisher Exact||||
1624427|NCT02248974|2982987|Superiority|||||||0.98|||||||Fisher Exact||||
1624428|NCT02248974|2982994|Superiority|||||||0.12|||||||Fisher Exact||||
1624429|NCT02248974|2982995|Superiority|||||||0.74|||||||Wilcoxon (Mann-Whitney)||||
1624430|NCT02248974|2982996|Superiority|||||||0.77|||||||Wilcoxon (Mann-Whitney)||||
1624431|NCT02248974|2982998|Superiority|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1624432|NCT02248974|2982999|Superiority|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1624433|NCT02248974|2983000|Superiority|||||||0.006|||||||Wilcoxon (Mann-Whitney)||||
1624434|NCT02248974|2983001|Superiority|||||||0.45|||||||Wilcoxon (Mann-Whitney)||||
1624435|NCT02248974|2983002|Superiority|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1624436|NCT02248974|2983003|Superiority|||||||0.6|||||||Wilcoxon (Mann-Whitney)||||
1624437|NCT02248974|2983007|Superiority|||||||0.74|||||||Wilcoxon (Mann-Whitney)||||
1624438|NCT02248974|2983008|Superiority|||||||0.65|||||||Wilcoxon (Mann-Whitney)||||
1624439|NCT02248974|2983010|Superiority|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1624440|NCT02248974|2983011|Superiority|||||||0.006|||||||Wilcoxon (Mann-Whitney)||||
1624441|NCT02248974|2983012|Superiority|||||||0.13|||||||Wilcoxon (Mann-Whitney)||||
1624442|NCT02248974|2983013|Superiority|||||||0.95|||||||Wilcoxon (Mann-Whitney)||||
1624443|NCT02248974|2983014|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1624444|NCT02248974|2983015|Superiority|||||||0.94|||||||Wilcoxon (Mann-Whitney)||||
1624447|NCT02248974|2983018|Superiority|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Used Wilcoxon 2-sample test to see if DA group had significantly better (i.e. lower) Decisional Conflict Scores than no-DA (Control) group.|
1624448|NCT02248974|2983019|Superiority|||||||0.47|||||||Mixed Models Analysis|||The model uses a general linear mixed model with fixed effects for baseline KS score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.|
1624449|NCT02248974|2983020|Superiority|||||||0.01|||||||Mixed Models Analysis|||The model uses a general linear mixed model with fixed effects for baseline Knowledge Scale score, time (discrete), arm, and a time-arm interaction term. The matrix of correlated residual terms assumes an unstructured format.|
1624450|NCT02248961|2983022|Other||||||=|0|||||||Mantel Haenszel||||
1624451|NCT02248961|2983023|Other||||||=|0|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.|||
1624452|NCT02248961|2983024|Other||||||=|0|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.|||
1624453|NCT02248961|2983025|Other||||||=|0|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.|||
1624454|NCT02248961|2983026|Other||||||=|0|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.|||
1624455|NCT02248961|2983027|Other||||||=|0|||||||Mixed Models Analysis|The investigational site was included as random effect. The baseline levels of SBP and the treatment group were included as fixed effects.|||
1624456|NCT02248961|2983028|Other|It was calculated that at least 140 patients (70 patients per group) must be enrolled into the study to achieve 80% power. With regard to 20% of patients withdrawn prematurely or data not suitable for analysis, it was necessary to include at least 176 patients (88 per group) into the study.|Mean Difference (Final Values)|-0.18|Standard Error of the Mean|1.0|=|0|1-Sided|95.0||1.47|||Mixed Models Analysis|||"The null hypothesis (H0) is that there is a decrease in SBP on the background treatment with Kanarb (fimasartan), that is at least 5.5 mmHg lower compared to Cozaar® (losartan).~Test of the hypotheses was performed using mixed linear models, where the site effect was considered a random effect, and the treatment group effect was considered a fixed effect. Baseline SBP on the study arm was included into the model as a covariate (a fixed effect) in all cases."|
1624457|NCT02248922|2983029|Other|||||||0.3502|||||||ANOVA||||
1624458|NCT02248922|2983030|Other|||||||0.3963|||||||ANOVA||||
1624459|NCT02248922|2983031|Other|||||||0.4249|||||||ANOVA||||
1624460|NCT02248922|2983032|Other|||||||0.591|||||||ANOVA||||
1624461|NCT02248922|2983033|Other|||||||0.354|||||||ANOVA||||
1624462|NCT02248922|2983034|Other|||||||0.6961|||||||ANOVA||||
1624463|NCT02248922|2983035|Other|||||||0.4099|||||||ANOVA||||
1624464|NCT02248675|2983083|Superiority or Other||||||<|0.001|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment|||
1624465|NCT02248675|2983084|Superiority or Other||||||<|0.001|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment|||
1624466|NCT02248675|2983085|Superiority or Other|||||||0.627|||||||Regression, Linear||||
1624467|NCT02248675|2983086|Superiority or Other|||||||0.153|||||||Regression, Linear|multiple regression controlling for baseline values of the dependent variable was used to examine between group effects at post-treatment|||
1624468|NCT02248662|2983087|Other||Odds Ratio (OR)|1.9|||<|0.05|2-Sided|95.0|1.27|2.84|||Chi-squared||||
1624469|NCT02248662|2983087|Other|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Odds Ratio (OR)|1.05|||<|0.05|2-Sided|95.0|0.71|1.56||A two-sided p value of less than 0.05 was considered to indicate statistical significance.|Chi-squared|||Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.|
1624470|NCT02248662|2983087|Other|The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|Odds Ratio (OR)|1.0|||<|0.05|2-Sided|95.0||||A two-sided p value of less than 0.05 was considered to indicate statistical significance.|Regression, Logistic|Adjusted percentages for receipt of mastectomy were calculated by setting covariates to their observed mean values.|This group is the reference group.|Unadjusted associations between patient characteristics and the three-level cluster of treatment intensity for primary DCIS were evaluated using Chi-squared tests. We used multivariable modeling to adjust for potential confounders. We also conducted a sensitivity analysis using propensity score matching to balance regional treatment intensity for primary DCIS with respect to the covariates included in the multivariable models.|
1624471|NCT02248649|2983088|Superiority|||||||0.02|||||||Mixed Models Analysis||||
1624472|NCT02248649|2983089|Superiority|||||||0.04|||||||Mixed Models Analysis||||
1624473|NCT02248649|2983090|Superiority|||||||0.2|||||||Mixed Models Analysis|covariates: baseline age and years of education|||
1624474|NCT02248480|2983110|Superiority or Other (legacy)||||||<|0.0001|||||||Mixed Models Analysis||||
1624475|NCT02247960|2983119|Superiority or Other|||||||1|||||||Chi-squared||||
1624476|NCT02247804|2983120|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.66|Standard Error of the Mean|0.31||0.0362||95.0|-1.27|-0.04|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624477|NCT02247804|2983120|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.54|Standard Error of the Mean|0.32||0.086|2-Sided|95.0|-1.16|0.08|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624478|NCT02247804|2983120|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.82|Standard Error of the Mean|0.32||0.0107|2-Sided|95.0|-1.46|-0.19|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624479|NCT02247804|2983120|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.63|Standard Error of the Mean|0.32||0.0547|2-Sided|95.0|-1.26|0.01|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624480|NCT02247804|2983120|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.9|Standard Error of the Mean|0.3||0.0031|2-Sided|95.0|-1.5|-0.31|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624481|NCT02247804|2983120|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.85|Standard Error of the Mean|0.31||0.0057|2-Sided|95.0|-1.45|-0.25|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624482|NCT02247804|2983120|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|Standard Error of the Mean|0.34||0.0187|2-Sided|95.0|-1.47|-0.13|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624483|NCT02247804|2983120|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.01|Standard Error of the Mean|0.34||0.0033|2-Sided|95.0|-1.68|-0.34|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624484|NCT02247804|2983121|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.21|Standard Error of the Mean|0.35||0.5383||95.0|-0.9|0.47|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624485|NCT02247804|2983121|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.7|Standard Error of the Mean|0.35||0.0464||95.0|-1.4|-0.01|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624486|NCT02247804|2983122|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.33|Standard Error of the Mean|0.39||0.3904|2-Sided|95.0|-1.09|0.43|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624518|NCT02247531|2983142|Superiority||Difference in Adjusted Means|-1.1||||0.1754|2-Sided|95.0|-2.8|0.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.|
1624566|NCT02246673|2983242|Superiority or Other||Geometric Least Squares mean Ratio|59.6|||<|0.0007|2-Sided|95.0|28.85|90.34|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3|
1624487|NCT02247804|2983122|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.41|Standard Error of the Mean|0.39||0.295||95.0|-1.17|0.36|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624488|NCT02247804|2983123|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.66|Standard Error of the Mean|0.31||0.0362||95.0|-1.27|-0.04|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624489|NCT02247804|2983123|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|0.08|Standard Error of the Mean|0.32||0.086||95.0|-1.16|0.08|||MMRM|||Week 6, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624490|NCT02247804|2983124|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.82|Standard Error of the Mean|0.32||0.0107||95.0|-1.46|-0.19|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624491|NCT02247804|2983124|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.63|Standard Error of the Mean|0.32||0.0547||95.0|-1.26|0.01|||MMRM|||Week 6, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624492|NCT02247804|2983125|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.9|Standard Error of the Mean|0.3||0.0031||95.0|-1.5|-0.31|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624493|NCT02247804|2983125|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.85|Standard Error of the Mean|0.31||0.0057||95.0|-1.45|-0.25|||MMRM|||Week 2, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624494|NCT02247804|2983126|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.8|Standard Error of the Mean|0.34||0.0187|2-Sided|95.0|-1.47|-0.13|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624495|NCT02247804|2983126|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-1.01|Standard Error of the Mean|0.34||0.0033|2-Sided|95.0|-1.68|-0.34|||MMRM|||Week 2, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624496|NCT02247804|2983127|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.21|Standard Error of the Mean|0.35||0.5383|2-Sided|95.0|-0.9|0.47|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 10 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624519|NCT02247531|2983142|Superiority||Difference in Adjusted Means|-0.1||||0.8931|2-Sided|95.0|-1.8|1.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.|
1624520|NCT02247531|2983143|Superiority||Odds Ratio (OR)|1.0||||0.9104|2-Sided|95.0|0.6|1.6|||Regression, Logistic||||
1624521|NCT02247531|2983143|Superiority||Odds Ratio (OR)|1.1||||0.6892|2-Sided|95.0|0.7|1.8|||Regression, Logistic||||
1624497|NCT02247804|2983127|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.7|Standard Error of the Mean|0.35||0.0464|2-Sided|95.0|-1.4|-0.01|||MMRM|||Week 12, Hour 2: The null hypothesis was that bimatoprost SR 15 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624498|NCT02247804|2983127|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.33|Standard Error of the Mean|0.39||0.3904|2-Sided|95.0|-1.09|0.43|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 10 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624499|NCT02247804|2983127|Non-Inferiority|MMRM analyses was used with response variable:IOP time-matched change from baseline;Fixed factors: Treatment,timepoint,treatment-by-timepoint interaction and baseline IOP stratification;Covariate:Time-matched baseline IOP and timepoint by time-matched baseline IOP interaction. Unstructured covariance matrix was used.|Least-squares Mean Difference|-0.41|Standard Error of the Mean|0.39||0.295|2-Sided|95.0|-1.17|0.36|||MMRM|||Week 12, Hour 0: The null hypothesis was that bimatoprost SR 15 μg was to be declared noninferior to timolol 0.5% if the upper limit of the 95% CI was ≤ 1.5 mm Hg for all scheduled timepoints (Hours 0 and 2 at Weeks 2, 6, 12).|
1624500|NCT02247531|2983134|Superiority||Difference in Adjusted Means|0.182||||0.1359|2-Sided|95.0|-0.058|0.422|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624501|NCT02247531|2983134|Superiority||Difference in Adjusted Means|0.34||||0.0063|2-Sided|95.0|0.097|0.584|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624502|NCT02247531|2983134|Superiority||Difference in Adjusted Means|0.025||||0.8105|2-Sided|95.0|-0.18|0.23|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624503|NCT02247531|2983134|Superiority||Difference in Adjusted Means|0.049||||0.6333|2-Sided|95.0|-0.153|0.252|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624504|NCT02247531|2983135|Superiority||Difference in Adjusted Means|0.02||||0.7475|2-Sided|95.0|-0.09|0.13|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624505|NCT02247531|2983135|Superiority||Difference in Adjusted Means|0.04||||0.5227|2-Sided|95.0|-0.07|0.14|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624506|NCT02247531|2983136|Superiority||Difference in Adjusted Means|0.6||||0.6822|2-Sided|95.0|-2.26|3.45|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624507|NCT02247531|2983136|Superiority||Difference in Adjusted Means|1.04||||0.4795|2-Sided|95.0|-1.84|3.91|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624508|NCT02247531|2983137|Superiority||Difference in Adjusted Means|2.2||||0.0833|2-Sided|95.0|-0.29|4.68|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624509|NCT02247531|2983137|Superiority||Difference in Adjusted Means|2.64||||0.0388|2-Sided|95.0|0.14|5.14|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624510|NCT02247531|2983138|Superiority||Difference in Adjusted Means|1.03||||0.3202|2-Sided|95.0|-1.01|3.07|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624511|NCT02247531|2983138|Superiority||Difference in Adjusted Means|1.22||||0.2438|2-Sided|95.0|-0.83|3.27|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624512|NCT02247531|2983139|Superiority||Difference in Adjusted Means|-1.72||||0.5945|2-Sided|95.0|-8.08|4.63|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.|
1624513|NCT02247531|2983139|Superiority||Difference in Adjusted Means|0.12||||0.9713|2-Sided|95.0|-6.28|6.52|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, biomarker status, modified baseline BCVA, and sex.|
1624514|NCT02247531|2983140|Superiority||Difference in Adjusted Means|1.07||||0.7443|2-Sided|95.0|-5.37|7.52|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624515|NCT02247531|2983140|Superiority||Difference in Adjusted Means|1.35||||0.6841|2-Sided|95.0|-5.16|7.85|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624516|NCT02247531|2983141|Superiority||Odds Ratio (OR)|0.9||||0.8382|2-Sided|95.0|0.6|1.6|||Regression, Logistic||||
1624517|NCT02247531|2983141|Superiority||Odds Ratio (OR)|1.3||||0.3707|2-Sided|95.0|0.7|2.2|||Regression, Logistic||||
1624522|NCT02247531|2983144|Superiority||Difference in Adjusted Means|0.3||||0.7885|2-Sided|95.0|-1.6|2.1|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.|
1624523|NCT02247531|2983144|Superiority||Difference in Adjusted Means|0.7||||0.4651|2-Sided|95.0|-1.2|2.5|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.|
1624524|NCT02247531|2983145|Superiority||Difference in Adjusted Means|-0.26||||0.6117|2-Sided|95.0|-1.25|0.74|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624525|NCT02247531|2983145|Superiority||Difference in Adjusted Means|0.1||||0.8358|2-Sided|95.0|-0.88|1.09|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624526|NCT02247531|2983146|Superiority||Difference in Adjusted Means|1.3||||0.5587|2-Sided|95.0|-3.1|5.7|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624527|NCT02247531|2983146|Superiority||Difference in Adjusted Means|-0.4||||0.84|2-Sided|95.0|-4.8|3.9|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624528|NCT02247531|2983147|Superiority||Difference in Adjusted Means|0.087||||0.2739|2-Sided|95.0|-0.069|0.243|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624529|NCT02247531|2983147|Superiority||Difference in Adjusted Means|0.157||||0.0479|2-Sided|95.0|0.001|0.313|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624530|NCT02247479|2983148|Superiority||Difference in Adjusted Means|0.006||||0.9676|2-Sided|95.0|-0.283|0.294|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624531|NCT02247479|2983148|Superiority||Difference in Adjusted Means|-0.033||||0.824|2-Sided|95.0|-0.322|0.257|||MMRM|||CFI Negative: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624532|NCT02247479|2983148|Superiority||Difference in Adjusted Means|0.077||||0.5317|2-Sided|95.0|-0.165|0.319|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624533|NCT02247479|2983148|Superiority||Difference in Adjusted Means|-0.022||||0.8612|2-Sided|95.0|-0.266|0.223|||MMRM|||CFI Positive: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624534|NCT02247479|2983149|Superiority||Difference in Adjusted Means|-0.08||||0.1222|2-Sided|95.0|-0.19|0.02|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624535|NCT02247479|2983149|Superiority||Difference in Adjusted Means|-0.07||||0.2075|2-Sided|95.0|-0.18|0.04|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline Mean FRI Index score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624536|NCT02247479|2983150|Superiority||Difference in Adjusted Means|-1.6||||0.2515|2-Sided|95.0|-4.33|1.13|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624537|NCT02247479|2983150|Superiority||Difference in Adjusted Means|0.99||||0.4855|2-Sided|95.0|-1.79|3.76|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624538|NCT02247479|2983151|Superiority||Difference in Adjusted Means|-1.94||||0.1399|2-Sided|95.0|-4.51|0.64|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624539|NCT02247479|2983151|Superiority||Difference in Adjusted Means|-0.22||||0.8659|2-Sided|95.0|-2.84|2.39|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624540|NCT02247479|2983152|Superiority||Difference in Adjusted Means|-1.56||||0.1193|2-Sided|95.0|-3.53|0.4|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624541|NCT02247479|2983152|Superiority||Difference in Adjusted Means|-0.36||||0.7246|2-Sided|95.0|-2.35|1.64|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline score, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624542|NCT02247479|2983153|Superiority||Difference in Adjusted Means|1.47||||0.6705|2-Sided|95.0|-5.31|8.25|||MMRM|||MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.|
1624543|NCT02247479|2983153|Superiority||Difference in Adjusted Means|1.72||||0.6204|2-Sided|95.0|-5.09|8.53|||MMRM|||MMRM analysis uses change as response variable included terms for treatment group, baseline maximum reading speed, type of reading charts, biomarker status, modified baseline BCVA and sex.|
1624629|NCT02246439|2983293|Superiority||Odds Ratio (OR)|1.3545||||0.1843|2-Sided|95.0|0.8647|2.1216|||Cochran-Mantel-Haenszel|Stratified by age.|||
1624544|NCT02247479|2983154|Superiority||Difference in Adjusted Means|-0.99||||0.7713|2-Sided|95.0|-7.66|5.69|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624545|NCT02247479|2983154|Superiority||Difference in Adjusted Means|5.66||||0.0991|2-Sided|95.0|-1.07|12.38|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, baseline maximum reading speed, type of reading charts, baseline BCVA of better seeing eye, biomarker status, and sex.|
1624546|NCT02247479|2983155|Superiority||Odds Ratio (OR)|1.0||||0.8764|2-Sided|95.0|0.6|1.8|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.|
1624547|NCT02247479|2983155|Superiority||Odds Ratio (OR)|1.0||||0.9448|2-Sided|95.0|0.6|1.7|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline LLVA, baseline GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.|
1624548|NCT02247479|2983156|Superiority||Difference in Adjusted Means|0.3||||0.7865|2-Sided|95.0|-1.7|2.3|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.|
1624549|NCT02247479|2983156|Superiority||Difference in Adjusted Means|0.6||||0.5695|2-Sided|95.0|-1.4|2.6|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline LLVA, GA lesion location, biomarker status, modified baseline BCVA ETDRS chart Snellen equivalent category, and sex.|
1624550|NCT02247479|2983157|Superiority||Odds Ratio (OR)|1.1||||0.7209|2-Sided|95.0|0.7|1.8|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.|
1624551|NCT02247479|2983157|Superiority||Odds Ratio (OR)|1.3||||0.3248|2-Sided|95.0|0.8|2.2|||Regression, Logistic|||Week 48: The adjusted analysis was based on a logistic regression analysis. The model included terms for treatment group, baseline BCVA, baseline GA lesion location, biomarker status, and sex.|
1624552|NCT02247479|2983158|Superiority||Difference in Adjusted Means|-0.2||||0.8423|2-Sided|95.0|-1.9|1.6|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.|
1624553|NCT02247479|2983158|Superiority||Difference in Adjusted Means|1.0||||0.2547|2-Sided|95.0|-0.7|2.8|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline BCVA, GA lesion location, biomarker status, and sex.|
1624554|NCT02247479|2983159|Superiority||Difference in Adjusted Means|-0.63||||0.2032|2-Sided|95.0|-1.6|0.35|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624555|NCT02247479|2983159|Superiority||Difference in Adjusted Means|0.28||||0.5538|2-Sided|95.0|-0.66|1.22|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline mean macular sensitivity, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624556|NCT02247479|2983160|Superiority||Difference in Adjusted Means|0.1||||0.9789|2-Sided|95.0|-5.0|5.2|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624557|NCT02247479|2983160|Superiority||Difference in Adjusted Means|-0.2||||0.935|2-Sided|95.0|-5.2|4.8|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline number of absolute scotomatous points, GA lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624558|NCT02247479|2983161|Superiority||Difference in Adjusted Means|0.051||||0.5901|2-Sided|95.0|-0.134|0.236|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624559|NCT02247479|2983161|Superiority||Difference in Adjusted Means|-0.019||||0.8381|2-Sided|95.0|-0.206|0.167|||MMRM|||Week 48: MMRM analysis uses change as response variable and included treatment group, visit, treatment−by−visit interaction, baseline GA area, lesion location, contiguity, biomarker status, modified baseline BCVA and sex.|
1624560|NCT02246673|2983242|Superiority or Other||Geometric Least Squares mean Ratio|151.66|||<|0.0001|2-Sided|95.0|116.59|186.73|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5|
1624561|NCT02246673|2983242|Superiority or Other||Geometric Least Squares mean Ratio|116.83|||<|0.0001|2-Sided|95.0|81.76|151.9|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5|
1624562|NCT02246673|2983242|Superiority or Other||Geometric Least Squares mean Ratio|188.83|||<|0.0001|2-Sided|95.0|152.55|225.1|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5|
1624563|NCT02246673|2983242|Superiority or Other||Geometric Least Squares mean Ratio|27.08|||<|0.0001|2-Sided|95.0|14.58|39.58|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4|
1624564|NCT02246673|2983242|Superiority or Other||Geometric Least Squares mean Ratio|33.7|||<|0.0001|2-Sided|95.0|21.21|46.2|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4|
1624565|NCT02246673|2983242|Superiority or Other||Geometric Least Squares mean Ratio|73.54|||<|0.0001|2-Sided|95.0|42.79|104.28|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3|
1625446|NCT02223364|2985264|Superiority|||||||0.493|||||||Wilcoxon (Mann-Whitney)||||
1624567|NCT02246673|2983242|Superiority or Other||Geometric Least Squares mean Ratio|169.93|||<|0.0001|2-Sided|95.0|122.82|217.03|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2|
1624568|NCT02246673|2983242|Superiority or Other||Geometric Least Squares mean Ratio|163.98|||<|0.0001|2-Sided|95.0|120.8|207.16|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2|
1624569|NCT02246673|2983242|Superiority or Other||Geometric Least Squares mean Ratio|178.58|||<|0.0001|2-Sided|95.0|129.25|227.9|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1|
1624570|NCT02246673|2983242|Superiority or Other||Geometric Least Squares mean Ratio|135.82|||<|0.0001|2-Sided|95.0|93.33|178.32|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1|
1624571|NCT02246673|2983243|Superiority or Other||Geometric Least Squares mean Ratio|176.57|||<|0.0001|2-Sided|95.0|120.77|232.38|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5|
1624572|NCT02246673|2983243|Superiority or Other||Geometric Least Squares mean Ratio|146.2|||<|0.0001|2-Sided|95.0|90.4|202.01|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5|
1624573|NCT02246673|2983243|Superiority or Other||Geometric Least Squares mean Ratio|236.08|||<|0.0001|2-Sided|95.0|178.29|293.86|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5|
1624574|NCT02246673|2983243|Superiority or Other||Geometric Least Squares mean Ratio|15.96|||<|0.035|2-Sided|95.0|1.2|30.71|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4|
1624575|NCT02246673|2983243|Superiority or Other||Geometric Least Squares mean Ratio|40.11|||<|0.0001|2-Sided|95.0|25.17|55.05|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4|
1624576|NCT02246673|2983243|Superiority or Other||Geometric Least Squares mean Ratio|91.5|||<|0.0001|2-Sided|95.0|54.81|128.19|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3|
1624577|NCT02246673|2983243|Superiority or Other||Geometric Least Squares mean Ratio|70.43|||<|0.0005|2-Sided|95.0|33.74|107.12|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3|
1624578|NCT02246673|2983243|Superiority or Other||Geometric Least Squares mean Ratio|188.75|||<|0.0001|2-Sided|95.0|138.04|239.46|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2|
1624579|NCT02246673|2983243|Superiority or Other||Geometric Least Squares mean Ratio|168.03|||<|0.0001|2-Sided|95.0|123.13|212.93|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2|
1624580|NCT02246673|2983243|Superiority or Other||Geometric Least Squares mean Ratio|174.47|||<|0.0001|2-Sided|95.0|125.52|233.42|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1|
1624581|NCT02246673|2983243|Superiority or Other||Geometric Least Squares mean Ratio|139.11|||<|0.0001|2-Sided|95.0|93.92|184.31|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1|
1624582|NCT02246673|2983244|Superiority or Other||Geometric Least Squares mean Ratio|26.35||||0.0009|2-Sided|95.0|11.59|41.11|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5|
1624583|NCT02246673|2983244|Superiority or Other||Geometric Least Squares mean Ratio|24.38||||0.0019|2-Sided|95.0|9.63|39.14|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5|
1624584|NCT02246673|2983244|Superiority or Other||Geometric Least Squares mean Ratio|30.83||||0.0002|2-Sided|95.0|15.62|46.04|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5|
1624585|NCT02246673|2983244|Superiority or Other||Geometric Least Squares mean Ratio|1.79||||0.614|2-Sided|95.0|-5.37|8.94|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect||Cohort 4|
1624586|NCT02246673|2983244|Superiority or Other||Geometric Least Squares mean Ratio|10.36||||0.0065|2-Sided|95.0|3.13|17.59|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4|
1624587|NCT02246673|2983244|Superiority or Other||Geometric Least Squares mean Ratio|20.52||||0.0055|2-Sided|95.0|6.56|34.48|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3|
1624588|NCT02246673|2983244|Superiority or Other||Geometric Least Squares mean Ratio|18.82||||0.0101|2-Sided|95.0|4.86|32.79|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3|
1624589|NCT02246673|2983244|Superiority or Other||Geometric Least Squares mean Ratio|18.37||||0.0008|2-Sided|95.0|8.3|28.44|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2|
1624590|NCT02246673|2983244|Superiority or Other||Geometric Least Squares mean Ratio|23.7|||<|0.0001|2-Sided|95.0|14.23|33.17|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2|
1624591|NCT02246673|2983244|Superiority or Other||Geometric Least Squares mean Ratio|20.08|||<|0.0013|2-Sided|95.0|8.38|31.79|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1|
1624592|NCT02246673|2983244|Superiority or Other||Geometric Least Squares mean Ratio|24.27|||<|0.0002|2-Sided|95.0|12.57|35.98|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1|
1624593|NCT02246673|2983245|Superiority or Other||Geometric Least Squares mean Ratio|-31.26|||<|0.0001|2-Sided|95.0|-34.77|-27.75|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5|
1624630|NCT02246439|2983294|Superiority||Odds Ratio (OR)|1.4755||||0.1089|2-Sided|95.0|0.917|2.3741||"This P-Value is for the 18 years of age and older group"|Cochran-Mantel-Haenszel||||
1624594|NCT02246673|2983245|Superiority or Other||Geometric Least Squares mean Ratio|-27.08|||<|0.0001|2-Sided|95.0|-30.6|-23.57|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5|
1624595|NCT02246673|2983245|Superiority or Other||Geometric Least Squares mean Ratio|-35.38|||<|0.0001|2-Sided|95.0|-38.89|-31.87|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 5|
1624596|NCT02246673|2983245|Superiority or Other||Geometric Least Squares mean Ratio|-4.98|||<|0.0221|2-Sided|95.0|-9.19|-0.76|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect||Cohort 4|
1624597|NCT02246673|2983245|Superiority or Other||Geometric Least Squares mean Ratio|-9.74|||<|0.0001|2-Sided|95.0|-13.97|-5.51|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 4|
1624598|NCT02246673|2983245|Superiority or Other||Geometric Least Squares mean Ratio|-15.51|||<|0.0001|2-Sided|95.0|-19.53|-11.49|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3|
1624599|NCT02246673|2983245|Superiority or Other||Geometric Least Squares mean Ratio|-17.52|||<|0.0001|2-Sided|95.0|-21.54|-13.5|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 3|
1624600|NCT02246673|2983245|Superiority or Other||Geometric Least Squares mean Ratio|-22.25|||<|0.0001|2-Sided|95.0|-26.36|-18.14|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2|
1624601|NCT02246673|2983245|Superiority or Other||Geometric Least Squares mean Ratio|-29.15|||<|0.0001|2-Sided|95.0|-33.15|-25.15|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 2|
1624602|NCT02246673|2983245|Superiority or Other||Geometric Least Squares mean Ratio|-25.29|||<|0.0001|2-Sided|95.0|-31.23|-19.34|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1|
1624603|NCT02246673|2983245|Superiority or Other||Geometric Least Squares mean Ratio|-28.18|||<|0.0001|2-Sided|95.0|-33.85|-22.51|||Mixed Models Analysis|The model included treatment and period as fixed effects and subject(s) as a random effect.||Cohort 1|
1624604|NCT02246647|2983260|Other||Mean Difference (Final Values)|0.01||||0.87|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1624605|NCT02246621|2983273|Superiority||Hazard Ratio (HR)|0.543||||2.1e-05|2-Sided|95.0|0.409|0.723|||Log Rank||||
1624606|NCT02246439|2983279|Superiority||Odds Ratio (OR)|2.0789||||0.0037|2-Sided|95.0|1.2676|3.4095|||Regression, Logistic||||
1624607|NCT02246439|2983280|Superiority||Odds Ratio (OR)|1.7922||||0.0152|2-Sided|95.0|1.1188|2.871|||Regression, Logistic||||
1624608|NCT02246439|2983281|Superiority||Odds Ratio (OR)|1.7356||||0.0303|2-Sided|95.0|1.0527|2.8615||"This P-Value is for the 18 years of age or older group."|Cochran-Mantel-Haenszel||||
1624609|NCT02246439|2983281|Superiority||Odds Ratio (OR)|4.4||||0.0924|2-Sided|95.0|0.7699|25.145||"This P-Value is for the <18 years of age group."|Cochran-Mantel-Haenszel||||
1624610|NCT02246439|2983282|Superiority||Odds Ratio (OR)|1.7356||||0.0303|2-Sided|95.0|1.0527|2.8615||"This P-Value is for the 18 years of age or older group."|Cochran-Mantel-Haenszel||||
1624611|NCT02246439|2983282|Superiority||Odds Ratio (OR)|4.4||||0.0934|2-Sided|95.0|0.7699|25.145||"This P-Value is for the <18 years of age group."|Cochran-Mantel-Haenszel||||
1624612|NCT02246439|2983282|Superiority||Odds Ratio (OR)|1.8673||||0.0103|2-Sided|95.0|1.1572|3.0131||"This P-Value is for the All ages group."|Cochran-Mantel-Haenszel|Stratified by age.|||
1624613|NCT02246439|2983283|Superiority||Odds Ratio (OR)|1.6397||||0.2797|2-Sided|95.0|0.6649|4.0437||"This P-Value is for the Nausea as bad as it could have been group."|Cochran-Mantel-Haenszel|Stratified by age.|||
1624614|NCT02246439|2983283|Superiority||Odds Ratio (OR)|2.0971||||0.0633|2-Sided|95.0|0.9614|4.5747||"This P-Value is for the Severe nausea group."|Cochran-Mantel-Haenszel|Stratified by age.|||
1624615|NCT02246439|2983283|Superiority||Odds Ratio (OR)|1.575||||0.3473|2-Sided|95.0|0.6096|4.0696||"This P-Value is for the Moderate nausea group."|Cochran-Mantel-Haenszel|Stratified by age.|||
1624616|NCT02246439|2983283|Superiority||Odds Ratio (OR)|2.1591||||0.3186|2-Sided|95.0|0.477|9.7735||"This P-Value is for the No nausea or mild nausea group."|Cochran-Mantel-Haenszel|Stratified by age.|||
1624617|NCT02246439|2983284|Superiority||Odds Ratio (OR)|0.6674||||0.572|2-Sided|95.0|0.1638|2.7191|||Cochran-Mantel-Haenszel||||
1624618|NCT02246439|2983285|Superiority||Odds Ratio (OR)|2.3012||||0.2005|2-Sided|95.0|0.6221|8.5129|||Cochran-Mantel-Haenszel||||
1624619|NCT02246439|2983286|Superiority||Hazard Ratio (HR)|0.992||||0.9511|2-Sided|95.0|0.7688|1.2801||"This P-Value is for the 18 years of age or older group."|Cox proportional hazards method||||
1624620|NCT02246439|2983286|Superiority||Hazard Ratio (HR)|1.5744||||0.3241|2-Sided|95.0|0.6388|3.8802||"This P-Value is for the <18 years of age group."|Cox proportional hazards method||||
1624621|NCT02246439|2983286|Superiority||Hazard Ratio (HR)|1.0275||||0.8289|2-Sided|95.0|0.8036|1.3138||"This P-Value was for the All ages group."|Cox proportional hazards method|Stratified by age.|||
1624622|NCT02246439|2983287|Superiority||Hazard Ratio (HR)|0.9445||||0.6332|2-Sided|95.0|0.7469|1.1943||"This P-Value is for the 18 years of age of older group."|Cox proportional hazards method||||
1624623|NCT02246439|2983287|Superiority||Hazard Ratio (HR)|1.4756||||0.3479|2-Sided|95.0|0.6549|3.325||"This P-Value is for the <18 years of age group."|Cox proportional hazards method||||
1624624|NCT02246439|2983287|Superiority||Hazard Ratio (HR)|0.9782||||0.8487|2-Sided|95.0|0.7803|1.2264||"This P-Value is for the All ages group."|Cox proportioanl hazards method|Stratified by age.|||
1624625|NCT02246439|2983288|Superiority|||||||0.589||||||This P-Value is for the BSS=7 group.|Wilcoxon (Mann-Whitney)||||
1624626|NCT02246439|2983290|Superiority||Odds Ratio (OR)|0.6566||||0.1235|2-Sided|95.0|0.3826|1.1268|||Cochran-Mantel-Haenszel|Stratified by age.|||
1624627|NCT02246439|2983291|Superiority||Odds Ratio (OR)|0.6677||||0.1049|2-Sided|95.0|0.4093|1.0892|||Cochran-Mantel-Haenszel|Stratified by age.|||
1624628|NCT02246439|2983292|Superiority||Odds Ratio (OR)|1.752||||0.0166|2-Sided|95.0|1.1058|2.776|||Cochran-Mantel-Haenszel|Stratified by age.|||
1625447|NCT02223364|2985265|Superiority|||||||0.132|||||||Wilcoxon (Mann-Whitney)||||
1624631|NCT02246439|2983294|Superiority||Odds Ratio (OR)|4.8||||0.0729|2-Sided|95.0|0.847|27.2024||"This P-Value is for the <18 years of age group."|Cochran-Mantel-Haenszel||||
1624632|NCT02246439|2983294|Superiority||Odds Ratio (OR)|1.6081||||0.0406|2-Sided|95.0|1.0194|2.5368||"This P-Value is for the All ages group"|Cochran-Mantel-Haenszel|Stratified by age.||The odds ratio and p-value were from a Cochran-Mantel-Haenszel test. For the ‘All ages’ category, the odds ratio and p-value were stratified by age.|
1624633|NCT02246166|2983361|Superiority or Other||Mean Difference (Final Values)|0.12||||0.8993|2-Sided|95.0|-1.71|1.94|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment||
1624634|NCT02246166|2983362|Superiority or Other||Mean Difference (Final Values)|0.56||||0.5208|2-Sided|95.0|-1.18|2.29|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment||
1624635|NCT02246166|2983363|Superiority or Other||Mean Difference (Final Values)|0.23||||0.7662|2-Sided|95.0|-1.32|1.78|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate|||
1624636|NCT02246166|2983364|Superiority or Other||Mean Difference (Final Values)|0.21||||0.7445|2-Sided|95.0|-1.07|1.49|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|||
1624637|NCT02246166|2983365|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.721|2-Sided|95.0|-1.23|0.86|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate.|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatme||
1624638|NCT02246166|2983366|Superiority or Other||Mean Difference (Final Values)|0.03||||0.9473|2-Sided|95.0|-0.77|0.83|||ANCOVA|From ANCOVA model with factors for treatment group and study site and baseline TSS score as a covariate|Difference is first named treatment minus the second named treatment such that a negative difference favors the first named treatment||
1624639|NCT02245737|2983377|Superiority||LS Mean Difference (Final Values)|-3.18|Standard Error of the Mean|0.48|<|0.001|2-Sided|95.0|-4.118|-2.247|||ANCOVA||||
1624640|NCT02245737|2983377|Superiority||LS Mean Difference (Final Values)|-2.34|Standard Error of the Mean|0.47|<|0.001|2-Sided|95.0|-3.258|-1.413|||ANCOVA||||
1624641|NCT02245737|2983378|Superiority||LS Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.0||0.568|2-Sided|95.0|-0.013|0.007|||ANCOVA||||
1624642|NCT02245737|2983378|Superiority||LS Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.0||0.21|2-Sided|95.0|-0.015|0.003|||ANCOVA||||
1624643|NCT02245737|2983379|Superiority||LS Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.01||0.66|2-Sided|95.0|-0.029|0.018|||ANCOVA||||
1624644|NCT02245737|2983379|Superiority||LS Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.01||0.426|2-Sided|95.0|-0.033|0.014|||ANCOVA||||
1624645|NCT02245737|2983380|Superiority||LS Mean Difference (Final Values)|-17.66|Standard Error of the Mean|2.66|<|0.001|2-Sided|95.0|-22.887|-12.428|||ANCOVA||||
1624646|NCT02245737|2983380|Superiority||LS Mean Difference (Final Values)|-13.68|Standard Error of the Mean|2.6|<|0.001|2-Sided|95.0|-18.785|-8.574|||ANCOVA||||
1624647|NCT02245737|2983381|Superiority||LS Mean Difference (Final Values)|-2.12|Standard Error of the Mean|1.27||0.095|2-Sided|95.0|-4.618|0.373|||ANCOVA||||
1624648|NCT02245737|2983381|Superiority||LS Mean Difference (Final Values)|-2.62|Standard Error of the Mean|1.33||0.05|2-Sided|95.0|-5.243|-0.002|||ANCOVA||||
1624649|NCT02245737|2983382|Superiority||LS Mean Difference (Final Values)|-15.31|Standard Error of the Mean|10.78||0.157|2-Sided|95.0|-36.555|5.938|||ANCOVA||||
1624650|NCT02245737|2983382|Superiority||LS Mean Difference (Final Values)|-19.87|Standard Error of the Mean|11.33||0.081|2-Sided|95.0|-42.21|2.464|||ANCOVA||||
1624651|NCT02245737|2983383|Superiority||LS Mean Difference (Final Values)|-73.25|Standard Error of the Mean|2.37|<|0.001|2-Sided|95.0|-77.926|-68.575|||ANCOVA||||
1624652|NCT02245737|2983383|Superiority||LS Mean Difference (Final Values)|-57.99|Standard Error of the Mean|2.47|<|0.001|2-Sided|95.0|-62.865|-53.108|||ANCOVA||||
1624653|NCT02245737|2983384|Superiority||LS Mean Difference (Final Values)|-65.48|Standard Error of the Mean|2.77|<|0.001|2-Sided|95.0|-70.947|-60.022|||ANCOVA||||
1624654|NCT02245737|2983384|Superiority||LS Mean Difference (Final Values)|-51.27|Standard Error of the Mean|2.89|<|0.001|2-Sided|95.0|-56.963|-45.578|||ANCOVA||||
1624655|NCT02245737|2983385|Superiority||LS Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.37||0.992|2-Sided|95.0|-0.714|0.721|||Mixed Models Analysis||||
1624656|NCT02245737|2983385|Superiority||LS Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.36||0.379|2-Sided|95.0|-0.391|1.027|||Mixed Models Analysis||||
1624657|NCT02245737|2983386|Superiority||LS Mean Difference (Final Values)|1.45|Standard Error of the Mean|1.15||0.208|2-Sided|95.0|-0.808|3.704|||Mixed Models Analysis||||
1624658|NCT02245737|2983386|Superiority||LS Mean Difference (Final Values)|1.77|Standard Error of the Mean|1.13||0.116|2-Sided|95.0|-0.441|3.986|||Mixed Models Analysis||||
1624659|NCT02245737|2983388|Superiority||LS Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.24||0.537|2-Sided|95.0|-0.328|0.63|||Mixed Models Analysis||||
1624660|NCT02245737|2983388|Superiority||LS Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.24||0.533|2-Sided|95.0|-0.322|0.622|||Mixed Models Analysis||||
1624661|NCT02245737|2983389|Superiority||LS Mean Difference (Final Values)|-0.13|Standard Error of the Mean|1.42||0.926|2-Sided|95.0|-2.918|2.655|||Mixed Models Analysis||||
1624662|NCT02245737|2983389|Superiority||LS Mean Difference (Final Values)|1.11|Standard Error of the Mean|1.4||0.428|2-Sided|95.0|-1.637|3.852|||Mixed Models Analysis||||
1624663|NCT02245737|2983390|Superiority||LS Mean Difference (Final Values)|0.61|Standard Error of the Mean|0.53||0.252|2-Sided|95.0|-0.437|1.66|||Mixed Models Analysis||||
1624664|NCT02245737|2983390|Superiority||LS Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.53||0.796|2-Sided|95.0|-1.172|0.899|||Mixed Models Analysis||||
1624665|NCT02245737|2983391|Superiority||LS Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.85||0.923|2-Sided|95.0|-1.58|1.743|||Mixed Models Analysis||||
1624666|NCT02245737|2983391|Superiority||LS Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.83||0.971|2-Sided|95.0|-1.609|1.669|||Mixed Models Analysis||||
1624667|NCT02245737|2983392|Superiority||LS Mean Difference (Final Values)|0.41|Standard Error of the Mean|0.78||0.599|2-Sided|95.0|-1.124|1.947|||Mixed Models Analysis||||
1624668|NCT02245737|2983392|Superiority||LS Mean Difference (Final Values)|-0.93|Standard Error of the Mean|0.77||0.232|2-Sided|95.0|-2.447|0.594|||Mixed Models Analysis||||
1624669|NCT02244580|2983427|Superiority or Other||Hazard Ratio (HR)|0.42||||0.001|2-Sided|95.0|0.25|0.71|||Regression, Cox||||
1624670|NCT02244580|2983428|Superiority or Other||Hazard Ratio (HR)|0.423||||0.0018|2-Sided|95.0|0.246|0.726|||Regression, Cox||||
1624671|NCT02243293|2983488|Non-Inferiority|The non-inferiority of the rate of sustained virologic response at 12 weeks after treatment as compared to historical control (in genotype 2 (GT2) DAA-naive participants in Part 4, arm S) was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 89% to achieve noninferiority.|Percentage of Participants|98.5|||||2-Sided|95.0|96.5|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.||
1624672|NCT02243202|2983497|Superiority or Other||Least Square Mean Difference|-6.7|Standard Error of the Mean|0.9|<|0.001||95.0|-8.5|-4.9|||Mixed Model for Repeated Measures||||
1624673|NCT02243202|2983497|Superiority or Other||Least Square Mean Difference|-1.3|Standard Error of the Mean|0.9|<|0.153|2-Sided|95.0|-3.1|0.5|||Mixed Model for Repeated Measures||||
1624674|NCT02243202|2983497|Superiority or Other||Least Square Mean Difference|-3.5|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-5.3|-1.7|||Mixed Model for Repeated Measures||||
1624675|NCT02243202|2983498|Superiority or Other||Least Square Mean Difference|-4.2|Standard Error of the Mean|1.7||0.015|2-Sided|95.0|-7.7|-0.8|||Mixed Model for Repeated Measures||||
1624676|NCT02243202|2983498|Superiority or Other||Least Square Mean Difference|-0.4|Standard Error of the Mean|1.8||0.827|2-Sided|95.0|-3.9|3.1|||Mixed Model for Repeated Measures||||
1624677|NCT02243202|2983498|Superiority or Other||Least Square Mean Difference|1.3|Standard Error of the Mean|1.8||0.456|2-Sided|95.0|-2.1|4.8|||Mixed Model for Repeated Measures||||
1624678|NCT02243202|2983499|Superiority or Other||Odds Ratio (OR)|10.2|||<|0.001|2-Sided|95.0|4.15|25.05|||Generalized linear Mixed Model||||
1624679|NCT02243202|2983499|Superiority or Other||Odds Ratio (OR)|1.12|||<|0.825|2-Sided|95.0|0.41|3.06|||Generalized linear Mixed Model||||
1624680|NCT02243202|2983499|Superiority or Other||Odds Ratio (OR)|4.15|||<|0.002|2-Sided|95.0|1.7|10.14|||Generalized linear Mixed Model||||
1624681|NCT02243202|2983500|Superiority or Other||Least Square Mean Difference|-6.9|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-8.6|-5.2|||Mixed Model for Repeated Measures||||
1624682|NCT02243202|2983500|Superiority or Other||Least Square Mean Difference|-1.3|Standard Error of the Mean|0.9|<|0.142|2-Sided|95.0|-3.1|0.4|||Mixed Model for Repeated Measures||||
1624683|NCT02243202|2983500|Superiority or Other||Least Square Mean Difference|-3.5|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-5.3|-1.8|||Mixed Model for Repeated Measures||||
1624684|NCT02243176|2983501|Superiority or Other||Mean Difference (Final Values)|0.69|Standard Error of the Mean|0.26||0.0078|2-Sided|95.0|0.18|1.19|||Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose||
1624685|NCT02243176|2983502|Superiority or Other||Mean Difference (Final Values)|7.48|Standard Error of the Mean|8.407||0.3739|2-Sided|95.0|-9.039|24.005|||ANCOVA||Mean difference=Saxagliptin - Acarbose||
1624686|NCT02243176|2983503|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.249||0.2248|2-Sided|95.0|-0.186|0.791|||ANCOVA||Mean difference=Saxagliptin - Acarbose||
1624687|NCT02243176|2983504|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.18||0.8915|2-Sided|95.0|-0.33|0.38|||Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose||
1624688|NCT02243176|2983505|Superiority or Other||Risk Ratio (RR)|1.28||||0.0518|2-Sided|95.0|0.98|1.67|||Cochran-Mantel-Haenszel|Stratefied by the baseline disease severity (HbA1c < 8.0% and ≥ 8.0%)|RR = Saxagliptin/Acarbose||
1624689|NCT02243176|2983506|Superiority or Other||Risk Ratio (RR)|0.92||||0.5044|2-Sided|95.0|0.74|1.15|||Cochran-Mantel-Haenszel|stratefied by baseline disease severity (HbA1c<8%, >=8%)|||
1624690|NCT02243176|2983507|Superiority or Other||Risk Ratio (RR)|0.22|||<|0.0001|2-Sided|95.0|0.12|0.39|||Cochran-Mantel-Haenszel|Stratefied by the baseline disease severity (HbA1c < 8.0% and ≥ 8.0%)|RR = Saxagliptin/Acarbose||
1624691|NCT02243176|2983508|Non-Inferiority or Equivalence|With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.|Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.09||0.7809|2-Sided|95.0|-0.21|0.15||This p value is for the hypothesis of superiority|Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|"H01: μS-μA≥ 0.4% vs Ha1: μS-μA< 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:~H02: μS-μA≥ 0 vs Ha2: μS-μA< 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0."|
1624692|NCT02243176|2983509|Non-Inferiority or Equivalence|With a total sample size of 480 patients randomized and an expected drop-out rate of 20%, the trial will be powered at 90% to establish non-inferiority for the primary endpoint, at a one-sided alpha level of 0.025, with the non-inferiority margin of 0.4%, assuming the true effects are the same between treatments. The calculation is also based on the assumption that the standard deviation for the change in HbA1c is 1.2%.|Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.09||0.6236|2-Sided|95.0|-0.22|0.13||This p value is for the hypothesis of superiority|Mixed Model Repeated Measures||Mean difference=Saxagliptin - Acarbose|"H01: μS-μA≥ 0.4% vs Ha1: μS-μA< 0.4%. Null hypothesis will be rejected if the upper limit of 2-sided 95% CI is below 0.4%.If the null hypothesis above (H01) is rejected, the following hypothesis will be tested to further establish superiority:~H02: μS-μA≥ 0 vs Ha2: μS-μA< 0. This null hypothesis (H02) will be rejected if the upper limit of 2-sided 95% CI is below 0."|
1624693|NCT02243046|2983510|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups|
1624694|NCT02243046|2983511|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups|
1624695|NCT02243046|2983512|Superiority or Other|||||||0.571|||||||ANOVA|||The null hypothesis states that there is no difference between groups|
1624696|NCT02243046|2983513|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups|
1624697|NCT02243046|2983514|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1624698|NCT02243046|2983515|Superiority or Other|||||||0.091|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1624699|NCT02242942|2983540|Superiority||Difference in Response Rates|0.93||||0.7169|2-Sided|95.0|-4.66|6.51|||Cochran-Mantel-Haenszel|P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.|95% CI for difference in rates were constructed using Anderson-Hauck method.||
1624700|NCT02242942|2983542|Superiority||Difference in Response Rates|1.85||||0.5612|2-Sided|95.0|-4.63|8.33||P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.||
1624701|NCT02242942|2983543|Superiority||Difference in MRD Negative Rates|38.43|||<|0.0001|2-Sided|95.0|30.15|46.71|||Chi-squared||95% CI for difference in rates were constructed using Anderson-Hauck method.||
1624702|NCT02242942|2983544|Superiority||Difference in MRD Negative Rates|32.87|||<|0.0001|2-Sided|95.0|23.76|41.98|||Chi-squared||95% CI for difference in rates were constructed using Anderson-Hauck method.||
1624703|NCT02242942|2983546|Superiority||Difference in MRD Negative Rates|39.81|||<|0.0001|2-Sided|95.0|31.27|48.36|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.||
1624704|NCT02242942|2983547|Superiority||Difference in MRD Negative Rates|40.28|||<|0.0001|2-Sided|95.0|31.45|49.1|||Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.||
1624705|NCT02242942|2983548|Superiority||Difference in Response Rates|26.39|||<|0.0001|2-Sided|95.0|17.41|35.36||P-value was assessed using CMH test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% CI for difference in rates were constructed using Anderson-Hauck method.||
1624706|NCT02242942|2983549|Superiority||Difference in Response Rates|13.43||||0.0007|2-Sided|95.0|5.47|21.38||P-value was assessed using Cochran-Mantel-Haenszel (CMH) test stratified by the IvRS randomization stratification factors.|Cochran-Mantel-Haenszel||95% Confidence Interval (CI) for difference in rates were constructed using Anderson-Hauck method.||
1624707|NCT02242942|2983550|Superiority||Hazard Ratio (HR)|0.35|||<|0.0001|2-Sided|95.0|0.23|0.53|||Log Rank||Hazard Ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.||
1624708|NCT02242942|2983551|Superiority||Hazard Ratio (HR)|0.33|||<|0.0001|2-Sided|95.0|0.22|0.51|||Log Rank||Hazard ratios were estimated by Cox regression model. Stratification factors: Binet and Geographic region.||
1624709|NCT02242643|2983567|Non-Inferiority or Equivalence|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.62|||||2-Sided|95.0|0.56|0.69|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).||
1624710|NCT02242643|2983567|Non-Inferiority or Equivalence|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.65|||||2-Sided|95.0|0.59|0.71|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).||
1624711|NCT02242643|2983567|Non-Inferiority or Equivalence|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT Ratio|0.85|||||2-Sided|95.0|0.77|0.94|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).||
1624712|NCT02242643|2983567|Non-Inferiority or Equivalence|Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.|Adjusted GMT ratio|0.85|||||2-Sided|95.0|0.77|0.95|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).||
1624713|NCT02242643|2983568|Non-Inferiority or Equivalence|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-11.75|||||2-Sided|95.0|-15.28|-8.21|||||For B/Brisbane/60/2008 (Victoria) vaccine strain.||
1624714|NCT02242643|2983568|Non-Inferiority or Equivalence|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-16.38|||||2-Sided|95.0|-20.68|-12.02|||||For B/Massachusetts/2/2012 (Yamagata) vaccine strain||
1624715|NCT02242643|2983568|Non-Inferiority or Equivalence|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|SCR Difference (%)|-6.74|||||2-Sided|95.0|-10.68|-2.8|||||For A/Texas/50/2012 (H3N2) vaccine strain||
1624716|NCT02242643|2983568|Non-Inferiority or Equivalence|Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.|Seroconversion rate (SCR) Difference (%)|-6.32|||||2-Sided|95.0|-10.34|-2.27|||||For A/California/7/2009 (H1N1) vaccine strain.||
1624717|NCT02242305|2983577|Superiority or Other|||||||0.531|||||||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline score as covariates was used.|||
1624718|NCT02242305|2983582|Superiority or Other|||||||0.079|||||||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.|||
1624719|NCT02242305|2983583|Superiority or Other||Median Difference (Final Values)|-0.05||||0.809|2-Sided|95.0|-0.39|0.33|||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.|Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 1 day and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.||
1624720|NCT02242305|2983583|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.809|2-Sided|90.0|-0.33|0.27|||ANCOVA|Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.|Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 3 days and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.||
1624721|NCT02242201|2983584|Superiority|||||||0.167|||||||Fisher Exact|||Pain with movement|
1624722|NCT02242201|2983584|Superiority|||||||1|||||||Fisher Exact|||Pain at rest|
1624723|NCT02242201|2983585|Superiority|||||||1|||||||Fisher Exact|||Fall requiring medical attention|
1624724|NCT02242201|2983585|Superiority|||||||1|||||||Fisher Exact|||Wound infection|
1624725|NCT02242201|2983585|Superiority|||||||0.843|||||||Fisher Exact|||Operative extremity neurologic changes|
1624726|NCT02242201|2983586|Superiority|||||||0.026|||||||t-test, 1 sided|||Baseline vs 3 months|
1624727|NCT02242201|2983586|Superiority|||||||0.046|||||||t-test, 1 sided|||Baseline vs 3 months|
1624728|NCT02242201|2983586|Superiority|||||||0.112|||||||t-test, 1 sided|||Baseline vs 3 months|
1624729|NCT02242201|2983586|Superiority|||||||0.898|||||||ANOVA||||
1624730|NCT02242201|2983587|Superiority||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months|
1624731|NCT02242201|2983587|Superiority||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months|
1624732|NCT02242201|2983587|Superiority||||||<|0.001|||||||t-test, 1 sided|||Baseline vs 3 months|
1624733|NCT02242201|2983587|Superiority||||||<|0.986|||||||ANOVA||||
1624734|NCT02242201|2983588|Superiority|||||||0.447|||||||Kruskal-Wallis|||Pain with movement|
1624735|NCT02242201|2983588|Superiority|||||||0.776|||||||Kruskal-Wallis|||Pain at rest|
1624736|NCT02242201|2983589|Superiority|||||||0.968|||||||Regression, Cox|||Baseline vs 3 months|
1624737|NCT02242201|2983589|Superiority|||||||0.216|||||||Regression, Cox|||Baseline vs 3 months|
1624738|NCT02242201|2983589|Superiority|||||||0.147|||||||Regression, Cox|||Baseline vs 3 months|
1624739|NCT02242201|2983589|Superiority|||||||0.113|||||||Regression, Cox|||Baseline vs 3 months|
1624740|NCT02242201|2983589|Superiority|||||||0.3|||||||Regression, Cox|||3 month follow-up|
1624741|NCT02242201|2983589|Superiority|||||||0.251|||||||Regression, Cox|||Baseline|
1624742|NCT02242201|2983590|Superiority|||||||0.772|||||||Kruskal-Wallis||||
1624743|NCT02242201|2983591|Superiority|||||||0.232|||||||Wilcoxon (Mann-Whitney)|||POD 2|
1624744|NCT02242201|2983591|Superiority|||||||0.893|||||||Wilcoxon (Mann-Whitney)|||POD 2|
1624745|NCT02242201|2983591|Superiority|||||||0.313|||||||Wilcoxon (Mann-Whitney)|||POD 2|
1624746|NCT02242201|2983591|Superiority|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||POD 1|
1624747|NCT02242201|2983591|Superiority|||||||0.536|||||||Wilcoxon (Mann-Whitney)|||POD 1|
1624748|NCT02242201|2983591|Superiority|||||||0.358|||||||Wilcoxon (Mann-Whitney)|||POD 1|
1624749|NCT02242201|2983591|Superiority|||||||0.501|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU|
1624750|NCT02242201|2983591|Superiority|||||||0.744|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU|
1624751|NCT02242201|2983591|Superiority|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||POD 0 post PACU|
1624752|NCT02242201|2983591|Superiority|||||||0.052|||||||Wilcoxon (Mann-Whitney)|||PACU|
1624753|NCT02242201|2983591|Superiority|||||||0.516|||||||Wilcoxon (Mann-Whitney)|||PACU|
1624754|NCT02242201|2983591|Superiority|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||PACU|
1624755|NCT02242201|2983591|Superiority|||||||0.142|||||||Wilcoxon (Mann-Whitney)|||Intraoperative|
1624756|NCT02242201|2983591|Superiority|||||||0.837|||||||Wilcoxon (Mann-Whitney)|||Intraoperative|
1624757|NCT02242201|2983591|Superiority|||||||0.179|||||||Wilcoxon (Mann-Whitney)|||Intraoperative|
1624758|NCT02242201|2983591|Superiority|||||||0.802|||||||Wilcoxon (Mann-Whitney)|||Preoperative|
1624759|NCT02242201|2983591|Superiority|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Preoperative|
1624760|NCT02242201|2983591|Superiority|||||||0.948|||||||Wilcoxon (Mann-Whitney)|||Preoperative|
1624761|NCT02242201|2983592|Superiority|||||||0.103|||||||Wilcoxon (Mann-Whitney)||||
1624762|NCT02242201|2983592|Superiority|||||||0.662|||||||Wilcoxon (Mann-Whitney)||||
1624763|NCT02242201|2983592|Superiority|||||||0.033|||||||Wilcoxon (Mann-Whitney)||||
1624764|NCT02242019|2983593|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1624765|NCT02242019|2983594|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1624766|NCT02241733|2983611|Superiority|||||||0.76|||||||t-test, 2 sided||||
1624767|NCT02241733|2983612|Superiority|||||||0.8|||||||t-test, 2 sided||||
1624768|NCT02241733|2983613|Superiority|||||||0.078|||||||t-test, 2 sided||||
1624769|NCT02241733|2983614|Superiority|||||||0.94|||||||t-test, 2 sided|||An independent t-test was completed.|
1624834|NCT02238483|2983884|Superiority or Other||Mean Difference (Net)|-0.12||||0.2694|2-Sided|95.0|-0.34|0.1|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo||
1624770|NCT02240693|2983651|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.041||0.6492|2-Sided|95.0|-0.098|0.061||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (Pooled BI 409306 minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction. The study identifier is also a categorical covariate for the twin studies analyses.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences
1624771|NCT02240693|2983651|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.057||0.1288|2-Sided|95.0|-0.199|0.025||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences
1624772|NCT02240693|2983651|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.056||0.9321|2-Sided|95.0|-0.105|0.115||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences
1624773|NCT02240693|2983651|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.057||0.9512|2-Sided|95.0|-0.116|0.109||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.
1624774|NCT02240693|2983651|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.056||0.8694|2-Sided|95.0|-0.101|0.12||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|"Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, current Acetylcholine Esterase Inhibitor (AChEI) use (Yes, No), and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.~The study identifier is also a categorical covariate for the twin studies analyses."|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.
1624775|NCT02240693|2983652|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-2.51|Standard Error of the Mean|1.072||0.0209|2-Sided|95.0|-4.64|-0.39||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences
1624776|NCT02240693|2983652|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-1.12|Standard Error of the Mean|1.072||0.2978|2-Sided|95.0|-3.25|1.0||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences
1624777|NCT02240693|2983652|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.62|Standard Error of the Mean|1.12||0.5801|2-Sided|95.0|-2.84|1.6||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.
1624778|NCT02240693|2983652|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.26|Standard Error of the Mean|1.081||0.8137|2-Sided|95.0|-2.4|1.89||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.
1625448|NCT02223364|2985265|Superiority|||||||0.203|||||||Wilcoxon (Mann-Whitney)||||
1624779|NCT02240693|2983653|Superiority||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.25||0.7548|2-Sided|95.0|-0.42|0.58||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences
1624780|NCT02240693|2983653|Superiority||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.26||0.4948|2-Sided|95.0|-0.69|0.33||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences
1624781|NCT02240693|2983653|Superiority||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.25||0.1699|2-Sided|95.0|-0.15|0.84||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.
1624782|NCT02240693|2983653|Superiority||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.24||0.9491|2-Sided|95.0|-0.49|0.46||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.
1624783|NCT02240693|2983654|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|0.42|Standard Error of the Mean|1.144||0.7166|2-Sided|95.0|-1.85|2.69||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences
1624784|NCT02240693|2983654|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.49|Standard Error of the Mean|1.085||0.6553|2-Sided|95.0|-2.64|1.67||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences
1624785|NCT02240693|2983654|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|1.4|Standard Error of the Mean|1.122||0.2141|2-Sided|95.0|-0.82|3.63||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.
1624786|NCT02240693|2983654|Superiority|Analyses of covariance (ANCOVA) were used to assess between−group differences in the modelled changes from baseline to Week 12.|Mean Difference (Final Values)|-0.14|Standard Error of the Mean|1.102||0.8973|2-Sided|95.0|-2.33|2.04||p-value was nominal and not adjusted.|ANCOVA||Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|The dependent variable was the change from the baseline score at Week 12. The model included fixed, categorical covariates of treatment as well as fixed continuous covariates of baseline score.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.
1624787|NCT02240693|2983655|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.054||0.7905|2-Sided|95.0|-0.092|0.121||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (Pooled BI 409306 minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences
1624788|NCT02240693|2983655|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.077||0.5484|2-Sided|95.0|-0.106|0.199||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg twice daily (BID) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences
1624835|NCT02238483|2983885|Superiority or Other||Mean Difference (Net)|0.83||||0.6352|2-Sided|95.0|-2.62|4.29|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo||
1625276|NCT02227784|2984843|Superiority or Other (legacy)||Median Difference (Final Values)|52.22|||<|0.001|2-Sided|95.0|47.12|57.33|||ANCOVA||||
1624789|NCT02240693|2983655|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.078||0.8374|2-Sided|95.0|-0.171|0.139||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (BI 409306 50 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences
1624790|NCT02240693|2983655|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.076||0.3694|2-Sided|95.0|-0.22|0.082||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (BI 409306 25 mg QD minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.
1624791|NCT02240693|2983655|Superiority|H0: The dose group with the peak response in the respective model Mean NTB response = Mean NTB response of placebo.|Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.075||0.3236|2-Sided|95.0|-0.074|0.223||p-value was nominal and not adjusted.|Mixed Model Repeated Measurement (MMRM)|Kenward−Roger was used to model degrees of freedom.|Mean difference (BI 409306 10 milligram (mg) once daily (QD) minus Placebo matching BI 409306)|Mixed Model Repeated Measurement (MMRM) includes fixed, categorical effects of treatment, visit, and treatment-by-visit interaction, as well as the continuous fixed covariates of baseline, and baseline-by-visit interaction.|The mean difference is actually adjusted mean of difference and the dispersion value is standard error of differences.
1624792|NCT02240680|2983656|Superiority||Mean Difference (Final Values)|-11.5|Standard Error of the Mean|4.8||0.0178|2-Sided|95.0|-21.0|-2.0|||Mixed Models Analysis|Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, FPG, daily insulin dose as covariates|Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).||MMRM including fixed effects treatment, week and treatment by week interaction, linear covariates baseline HbA1c, baseline daily basal insulin, baseline FPG and baseline FPG by week interaction and random effect for patient. Within−patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).
1624793|NCT02240680|2983657|Other||Odds Ratio (OR)|3.731|Standard Error of the Mean|0.92|<|0.0001|2-Sided|95.0|2.302|6.048|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio||
1624794|NCT02240680|2983658|Other||Odds Ratio (OR)|4.689|Standard Error of the Mean|1.519|<|0.0001|2-Sided|95.0|2.485|8.848|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio||
1624795|NCT02240680|2983659|Other||Odds Ratio (OR)|5.018|Standard Error of the Mean|1.818|<|0.0001|2-Sided|95.0|2.468|10.206|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error of odds ratio||
1624796|NCT02240680|2983660|Other||Odds Ratio (OR)|1.149|Standard Error of the Mean|0.377||0.672|2-Sided|95.0|0.604|2.188|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error for odds ratio.|For glucose value < 54mg/dL according American Diabetes Association definition of clinically significant hypoglycaemia|
1624797|NCT02240680|2983660|Other||Odds Ratio (OR)|1.464|Standard Error of the Mean|0.397||0.1594|2-Sided|95.0|0.861|2.491|||Regression, Logistic|A logistic regression model with treatment as fixed effect and baseline HbA1c and baseline daily basal insulin dose as linear covariates was applied.|The dispersion value standard error of the mean is actually standard error for odds ratio.|For any hypoglycemia event accompanied by prespecified glucose value|
1624798|NCT02240680|2983661|Superiority||Mean Difference (Final Values)|-0.63|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.81|-0.46|||Mixed Models Analysis|Mixed model repeated measures(MMRM) included treatment, week and interaction as fixed effects, baseline HbA1c, daily basal insulin dose as covariates|Adjusted mean of all differences between HbA1c at baseline and after 24 weeks. It is based on all patients in the model (not only patients with a baseline and week 24 measurement).||MMRM including fixed effects treatment , week and treatment by week interaction linear covariates baseline HbA1c , baseline daily basal insulin and baseline HbA1c by week interaction and random effect for patient. Within−patient errors are modelled by unstructured covariance matrix. Adjusted mean is based on all patients in the model (not only patients with a baseline and week 24 measurement).
1624799|NCT02240667|2983664|Other|||||||0.8496|||||||stratified log-rank test|||Persistence in both treatment groups was compared by means of the stratified Log-rank test|
1624800|NCT02240368|2983676|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1624801|NCT02240368|2983677|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1624802|NCT02240368|2983678|Superiority or Other||||||<|0.01|||||||bootstrap||||
1624803|NCT02240368|2983679|Superiority or Other||||||<|0.01|||||||bootstrap||||
1624804|NCT02240186|2983682|Superiority|||||||0.01|||||||ANOVA||||
1624805|NCT02240186|2983683|Superiority|||||||0.01|||||||ANOVA||||
1624806|NCT02240186|2983684|Superiority|||||||0.01|||||||ANOVA||||
1624836|NCT02238483|2983886|Superiority or Other||Mean Difference (Net)|-0.37||||0.5474|2-Sided|95.0|-1.6|0.85|||Mixed Models Analysis||LSMean difference for overall treatment effect. Negative values for a difference show AZD7624 to have a favourable outcome compared to Placebo||
1624807|NCT02239692|2983734|Superiority or Other||Adjusted estimated odds ratio|9.18|||<|0.0001|2-Sided|95.0|4.36|19.32||p-value corresponds to a two-sided test of superiority.|Regression, Logistic|Logistic regression with the failure/success status as dependent variable, and treatment, country and timing of colonoscopy as factors.|The estimated odds ratio compares the odds of being a responder in the PICOPREP tailored dosing schedule vs. the PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.|
1624808|NCT02239692|2983735|Non-Inferiority or Equivalence|Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.|Adjusted estimated mean difference|-4.38|||<|0.0001|2-Sided|95.0|-5.34|-3.41||p-value corresponds to a two-sided test of superiority.|ANCOVA|ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.|Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.|
1624809|NCT02239692|2983736|Non-Inferiority or Equivalence|Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.|Adjusted estimated mean difference|-3.93|||<|0.0001|2-Sided|95.0|-4.99|-2.87||p-value corresponds to a two-sided test of superiority.|ANCOVA|ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.|Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.|Null hypothesis was no treatment difference between the two dosing schedules.|
1624810|NCT02239679|2983798|Superiority||||||<|0.0001||||||no adjustment for multiple comparison|Cochran-Mantel-Haenszel|stratified by site|||
1624811|NCT02239679|2983798|Superiority||||||<|0.0004||||||no adjustments for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site|||
1624812|NCT02239679|2983799|Superiority|||||||0.0089||||||no adjustment for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site|||
1624813|NCT02239679|2983799|Superiority|||||||0.0102||||||no adjustments for multiple comparisons|Cochran-Mantel-Haenszel|stratified by site|||
1624814|NCT02239679|2983805|Superiority|||||||0.0166|||||||ANCOVA||||
1624815|NCT02239601|2983819|Other||Odds Ratio (OR)|0.41||||0.053|2-Sided|95.0|0.17|1.01|||Mixed Models Analysis||||
1624816|NCT02239536|2983822|Other|||||||0.001|||||||Chi-squared||||
1624817|NCT02239536|2983822|Other|||||||0.05|||||||Chi-squared||||
1624818|NCT02239536|2983823|Other|||||||0.05|||||||Chi-squared||||
1624819|NCT02239328|2983835|Other|Multilevel random coefficient models estimated the mean score of each PROMIS domain as a function of time elapsed between date of surgery and assessment (in years), and patient comorbidity. Statistical significance of estimated fixed effects were assessed by the F-test statistic for type 3 tests, p < 0.05.|||||<|0.05|||||||ANOVA||||
1624820|NCT02239120|2983852|Superiority||Hazard Ratio (HR)|1.28||||0.0003|2-Sided|95.0|1.12|1.47|||Regression, Cox|Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.|||
1624821|NCT02239120|2983853|Superiority||Hazard Ratio (HR)|0.82||||0.4352|2-Sided|95.0|0.49|1.36|||Regression, Cox|Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.|||
1624822|NCT02239120|2983855|Superiority||Hazard Ratio (HR)|1.03||||0.9064|2-Sided|95.0|0.58|1.83|||Regression, Cox|Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.|||
1624823|NCT02239120|2983856|Superiority||Hazard Ratio (HR)|0.96||||0.8074|2-Sided|95.0|0.66|1.38|||Regression, Cox|Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.|||
1624824|NCT02239120|2983857|Superiority||Hazard Ratio (HR)|0.59||||0.0354|2-Sided|95.0|0.36|0.96|||Regression, Cox|Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.|||
1624825|NCT02239120|2983858|Superiority||Hazard Ratio (HR)|0.88||||0.1911|2-Sided|95.0|0.73|1.06|||Regression, Cox|Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.|||
1624826|NCT02239120|2983859|Superiority||Hazard Ratio (HR)|0.84||||0.0892|2-Sided|95.0|0.68|1.03|||Regression, Cox|Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.|||
1624827|NCT02239120|2983860|Superiority||Hazard Ratio (HR)|1.36||||0.1076|2-Sided|95.0|0.94|1.97|||Regression, Cox|Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.|||
1624828|NCT02239120|2983861|Superiority||Hazard Ratio (HR)|0.85||||0.1028|2-Sided|95.0|0.69|1.03|||Regression, Cox|Covariates in model are age(<or>= 75years), creatinine clearance < or >= 50mL/min and stroke or transient ischaemic attack(TIA) prior to index stroke.|||
1624829|NCT02238847|2983878|Superiority|||||||0.66|||||||Fisher Exact||||
1624830|NCT02238847|2983879|Non-Inferiority|The prespecified non-inferiority margin was set at 20%. This was chosen to support a practical study size while still able to identify major differences if this were the case.|||||<|0.01||||||Reported p-value of <0.01 is calculated p-value. (p<0.05 was considered significant)|Exact Non-inferiority||||
1624831|NCT02238483|2983881|Superiority or Other||Mean Difference (Net)|0.01||||0.1965|2-Sided|95.0|0.0|0.02|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo||
1624832|NCT02238483|2983882|Superiority or Other||Mean Difference (Net)|-0.02||||0.5416|2-Sided|95.0|-0.1|0.05|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo||
1624833|NCT02238483|2983883|Superiority or Other||Mean Difference (Net)|0.02||||0.5144|2-Sided|95.0|-0.03|0.07|||Mixed Models Analysis||LSMean difference for overall treatment effect. Positive values for a difference show AZD7624 to have a favourable outcome compared to Placebo||
1625277|NCT02227784|2984843|Superiority or Other (legacy)||Median Difference (Final Values)|46.35|||<|0.001|2-Sided|95.0|40.79|51.98|||ANCOVA||||
1624837|NCT02238483|2983887|Superiority or Other||rate ratio|0.84|Standard Error of the Mean|0.19||0.44|2-Sided|95.0|0.55|1.3|||regression, negative binomial||||
1624838|NCT02238483|2983888|Superiority or Other||Hazard Ratio (HR)|0.86||||0.5381|2-Sided|95.0|0.54|1.38|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.||
1624839|NCT02238483|2983889|Superiority or Other||rate ratio|1.12|Standard Error of the Mean|0.41||0.751|2-Sided|95.0|0.55|2.29|||regression, negative binomial||||
1624840|NCT02238483|2983890|Superiority or Other||Hazard Ratio (HR)|0.93||||0.8543|2-Sided|95.0|0.43|2.01|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.||
1624841|NCT02238483|2983891|Superiority or Other||rate ratio|1.5|Standard Error of the Mean|0.4||0.129|2-Sided|95.0|0.89|2.52|||regression, negative binomial||||
1624842|NCT02238483|2983892|Superiority or Other||Hazard Ratio (HR)|1.53||||0.1529|2-Sided|95.0|0.85|2.76|||Regression, Cox||||
1624843|NCT02238483|2983893|Superiority or Other||Rate ratio|1.4|Standard Error of the Mean|0.33||0.157|2-Sided|95.0|0.88|2.21|||regression, negative binomial||||
1624844|NCT02238483|2983894|Superiority or Other||Hazard Ratio (HR)|1.49||||0.1261|2-Sided|95.0|0.89|2.5|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.||
1624845|NCT02238483|2983895|Superiority or Other||Rate Ratio|1.33|Standard Error of the Mean|0.33||0.249|2-Sided|95.0|0.82|2.16|||regression, negative binomial||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.||
1624846|NCT02238483|2983896|Superiority or Other||Hazard Ratio (HR)|1.39||||0.2371|2-Sided|95.0|0.81|2.4|||Regression, Cox||A hazard ratio greater than 1 indicates a higher rate of incidence in the AZD7624 group.|H0: Hazard Ratio (AZD7624/placebo) equals 1 vs. H1: Hazard Ratio does not equal 1.|
1624847|NCT02238379|2983899|Superiority or Other|||||||0.05|||||||correlation||||
1624848|NCT02238379|2983900|Superiority or Other|||||||0.05|||||||correlation||||
1624849|NCT02238379|2983901|Superiority or Other|||||||0.05|||||||correlation||||
1624850|NCT02238379|2983903|Superiority or Other|||||||0.05|||||||correlation||||
1624851|NCT02238379|2983904|Superiority or Other|||||||0.008||||||Main Effect of Hemisphere|ANOVA|Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA||Only relevant for N170|
1624852|NCT02238379|2983904|Superiority or Other|||||||0.03||||||Main Effect of Spray|ANOVA|Spray (oxytocin, placebo) by Hemisphere (left, right) ANOVA||Only relevant for N170|
1624853|NCT02238379|2983905|Superiority or Other|||||||0.01||||||Main Effect of Hemisphere|ANOVA|Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA||Only relevant for N170|
1624854|NCT02238379|2983905|Superiority or Other|||||||0.006||||||Main Effect of Emotion|ANOVA|Spray Type (Oxytocin, Placebo), Face Type (Infant, Adult), Emotion (Neutral, Distressed), and Hemisphere (left, right) ANOVA||Only relevant for N170|
1624855|NCT02238379|2983906|Superiority or Other||||||>|0.27||||||No difference between Spray Types|t-test, 2 sided|Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)||LPP Analysis|
1624856|NCT02238379|2983906|Superiority or Other||||||>|0.17||||||No difference between Spray Types|t-test, 2 sided|Paired samples t-test comparing Spray Type (Oxytocin vs Placebo)||P300 Analysis|
1624857|NCT02238379|2983906|Superiority or Other||||||>|0.14||||||No Main Effects or Interactions|ANOVA|Spray Type (Oxytocin, Placebo) and Hemisphere (left, right) ANOVA||N170 Analysis|
1624858|NCT02238379|2983907|Superiority or Other||||||>|0.22||||||No Main Effects or Interactions|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||LPP Analysis|
1624859|NCT02238379|2983907|Superiority or Other||||||>|0.03||||||Spray Type by Face Type Interaction|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||P300 Analysis|
1624860|NCT02238379|2983907|Superiority or Other||||||>|0.03||||||Main Effect of Face Type|ANOVA|Spray Type (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) ANOVA||P300 Analysis|
1624861|NCT02238379|2983907|Superiority or Other||||||>|0.034||||||Main Effect of Face Type|ANOVA|Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA||N170 Analysis|
1624862|NCT02238379|2983907|Superiority or Other||||||>|0.003||||||Main Effect of Emotion|ANOVA|Spray (Oxytocin, Placebo) by Face Type (Infant, Adult) by Emotion (Distress, Neutral) by Hemisphere (Left, Right) ANOVA||N170 Analysis|
1624863|NCT02238028|2983945|Superiority or Other||||||<|0.05|||||||Paired t-test,2 sided||||
1624864|NCT02238028|2983946|Superiority or Other||||||<|0.05|||||||Paired t-test,2 sided|||Paired Student's t tests were used in the absence and presence of wearing respirators. HRV was log-transformed before regression analyses. Linear mixed-effect models were applied to investigate the effects of wearing respirators. Age, sex, body mass index, PM2.5 concentration, 48-h mean temperature and 48-h mean humidity were introduced into the model as fixed-effect terms. At last, we incorporated random-effect intercepts for subjects to account for correlations between repeated measurements.|
1624865|NCT02237950|2983949|Superiority|||||||0.008|||||||Regression, Logistic||||
1624866|NCT02237950|2983950|Superiority|||||||0.059|||||||Regression, Logistic||||
1624867|NCT02237950|2983951|Superiority|||||||0.012|||||||Regression, Logistic||||
1624868|NCT02237950|2983952|Superiority|||||||0.014|||||||Regression, Logistic||||
1624869|NCT02237950|2983953|Superiority|||||||0.002|||||||Regression, Logistic||||
1624870|NCT02237950|2983954|Superiority|||||||0.007|||||||Log Rank||||
1624871|NCT02237950|2983955|Superiority|||||||0.015|||||||Regression, Logistic||||
1624872|NCT02237911|2983956|Superiority||Mean Difference (Final Values)|51.0||||0.33|2-Sided|95.0|-52.0|154.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624873|NCT02237911|2983956|Superiority||Mean Difference (Final Values)|19.0||||0.676|2-Sided|95.0|-71.0|109.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1625009|NCT02232698|2984352|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.329||0.5623|2-Sided||||||ANCOVA|||Statistical analysis of time spent >180 mg/dL|
1624874|NCT02237911|2983956|Superiority||Mean Difference (Final Values)|-36.0||||0.581|2-Sided|95.0|-164.0|92.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624875|NCT02237911|2983956|Superiority||Mean Difference (Final Values)|-15.0||||0.787|2-Sided|95.0|-125.0|95.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624876|NCT02237911|2983956|Superiority||Mean Difference (Final Values)|15.0||||0.814|2-Sided|95.0|-112.0|142.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624877|NCT02237911|2983956|Superiority||Mean Difference (Final Values)|4.0||||0.943|2-Sided|95.0|-106.0|114.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624878|NCT02237911|2983957|Superiority||Mean Difference (Final Values)|0.02||||0.489|2-Sided|98.3|-0.003|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624879|NCT02237911|2983957|Superiority||Mean Difference (Final Values)|0.2||||0.015|2-Sided|98.3|0.02|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624880|NCT02237911|2983957|Superiority||Mean Difference (Final Values)|0.2||||0.052|2-Sided|98.3|-0.003|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624881|NCT02237911|2983957|Superiority||Mean Difference (Final Values)|0.2||||0.005|2-Sided|98.3|0.02|0.3|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624882|NCT02237911|2983957|Superiority||Mean Difference (Final Values)|0.2||||0.012|2-Sided|98.3|0.01|0.4|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624883|NCT02237911|2983957|Superiority||Mean Difference (Final Values)|0.3|||<|0.0001|2-Sided|98.3|0.1|0.4|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624884|NCT02237911|2983958|Superiority||Mean Difference (Final Values)|-1.3||||0.179|2-Sided|98.3|-3.6|1.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624885|NCT02237911|2983958|Superiority||Mean Difference (Final Values)|-2.2||||0.021|2-Sided|98.3|-4.5|0.1|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624886|NCT02237911|2983958|Superiority||Mean Difference (Final Values)|-0.8||||0.491|2-Sided|98.3|-3.7|2.0|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 6 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624887|NCT02237911|2983958|Superiority||Mean Difference (Final Values)|0.1||||0.93|2-Sided|98.3|-2.7|2.9|||Mixed Models Analysis|||Contrasts from a linear mixed models analysis at 3 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.|
1624888|NCT02237911|2983958|Superiority||Mean Difference (Final Values)|-2.1||||0.074|2-Sided|98.3|-5.0|0.7|||Mixed Models Analysis|||Contrasts from a linear mixed models analysis at 6 months adjusted by baseline age, gender, BMI, WOMAC-PF, knee flexion.|
1624889|NCT02237911|2983958|Superiority||Mean Difference (Final Values)|-2.1||||0.071|2-Sided|98.3|-4.9|0.7|||Mixed Models Analysis|Contrasts from a linear mixed models analysis at 3 months adjusted for randomization factors (age, gender, BMI, WOMAC-PF, knee flexion).|||
1624890|NCT02237898|2983962|Superiority|||||||0.3|||||||Wilcoxon (Mann-Whitney)||||
1624891|NCT02237196|2983975|Superiority||Mean Difference (Net)|-0.51|Standard Error of the Mean|0.5038||0.314|2-Sided|95.0|-1.51|0.49|||Longitudinal repeated measures analysis|Model adjusts for Site, Baseline TNSS AUC, and Baseline Cat exposure (low vs high)|||
1624892|NCT02237092|2983981|Superiority or Other||Risk Ratio (RR)|1.58|||<|0.05|2-Sided|95.0|1.05|2.58|||NNT||||
1624893|NCT02237092|2983982|Superiority or Other||||||<|0.02|||||||t-test, 2 sided||||
1624894|NCT02237092|2983983|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1624895|NCT02237092|2983984|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1624896|NCT02236611|2983988|Non-Inferiority or Equivalence|Alternate hypothesis: the difference between the trt means (umeclidinium minus glycopyrronium) would be > -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to glycopyrronium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to glycopyrronium.|Mean Difference (Final Values)|0.024||||0.1|2-Sided|95.0|-0.005|0.054|||Mixed Models Analysis||||
1624897|NCT02236598|2983989|Superiority|||||||0.1604|||||||ANCOVA||||
1624898|NCT02236598|2983990|Superiority|||||||0.5294|||||||ANCOVA||||
1624899|NCT02236598|2983991|Superiority|Change in 2-hour Glucose||||||0.7913|||||||ANCOVA||||
1624900|NCT02236598|2983991|Superiority|Change in 1-hour Glucose||||||0.6671|||||||ANCOVA||||
1624901|NCT02236598|2983991|Superiority|Change in Fasting Glucose||||||0.0963|||||||ANCOVA||||
1624902|NCT02236598|2983992|Superiority|||||||0.5582|||||||ANCOVA||||
1624903|NCT02235870|2984016|Superiority||Percentage Difference|32.8|||<|0.0001|2-Sided|95.0|23.1|42.5|||Chi-squared||||
1624904|NCT02235870|2984017|Superiority||Exact Confidence Interval|64.9|||<|0.0001|2-Sided|95.0|57.5|71.7|||Exact Test|||Subjects in the Obalon Treatment group with at least 2 Balloons and balloon therapy for at least 18 weeks.|
1624905|NCT02235870|2984018|Superiority||Least-Square Mean Difference|3.28||||0.0261|2-Sided|95.0|2.24|4.32|||ANCOVA||||
1624980|NCT02233517|2984319|Superiority||Mean Difference (Net)|-0.23|Standard Error of the Mean|0.37||0.55|2-Sided||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.||
1624906|NCT02235493|2984020|Superiority or Other|||||||0.125||||||The p-value is based on a nonparametric sign test to determine whether the median of change from Baseline in POMA-G score differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Videos were reviewed and scored by 3 independent raters who were masked to patient identifiers and the clinic visits and dates when the videos were recorded. Each rater scored the individual components required for the calculation of the total POMA-G score for each evaluable patient video. The median of the scores across the 3 raters was obtained for each individual component and summed to generate the median POMA-G score used in the analyses.|
1624907|NCT02235493|2984021|Superiority or Other|||||||0.0625||||||The p-value is based on a nonparametric sign test to determine whether the median of change from Baseline in MPOMA-G score differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Videos were reviewed and scored by 3 independent raters who were masked to patient identifiers and the clinic visits and dates when the videos were recorded. Each rater scored the individual components required for the calculation of the total MPOMA-G score for each evaluable patient video. The median of the scores across the 3 raters was obtained for each individual component and summed to generate the median MPOMA-G score used in the analyses.|
1624908|NCT02235077|2984028|Superiority||Odds Ratio (OR)|0.76||||0.5818|2-Sided|95.0|0.29|1.99|||Regression, Logistic||||
1624909|NCT02235077|2984029|Superiority||Mean Difference (Final Values)|-1.04||||0.6102|2-Sided|95.0|-5.02|2.95|||Regression, Linear||||
1624910|NCT02235077|2984030|Superiority||Odds Ratio (OR)|1.11||||0.7628|2-Sided|95.0|0.56|2.23|||Regression, Logistic||||
1624911|NCT02235077|2984031|Superiority||Mean Difference (Final Values)|-12.17||||0.0842|2-Sided|95.0|-25.98|1.65|||Regression, Linear||||
1624912|NCT02235077|2984032|Superiority||Mean Difference (Final Values)|0.11||||0.0846|2-Sided|95.0|-0.02|0.25|||Regression, Linear||||
1624913|NCT02235077|2984033|Superiority||Mean Difference (Final Values)|-1.02||||0.3528|2-Sided|95.0|-3.05|1.01|||Regression, Linear||||
1624914|NCT02235077|2984034|Superiority||Mean Difference (Final Values)|319.2||||0.5734|2-Sided|95.0|-797.4|1435.8|||Regression, Linear||||
1624915|NCT02235077|2984035|Superiority||Mean Difference (Final Values)|-0.01||||0.7673|2-Sided|95.0|-0.09|0.07|||Regression, Linear||||
1624916|NCT02235077|2984036|Superiority||Odds Ratio (OR)|1.23||||0.3039|2-Sided|95.0|0.83|1.81|||Chi-squared||||
1624917|NCT02235077|2984037|Superiority||Mean Difference (Final Values)|0.25||||0.4155|2-Sided|95.0|-0.35|0.86|||Regression, Linear||||
1624918|NCT02235077|2984038|Superiority||Mean Difference (Final Values)|0.05||||0.5688|2-Sided|95.0|-0.11|0.2|||Regression, Linear||||
1624919|NCT02234843|2984084|Other||Hazard Ratio (HR)|0.4||||0.1509|2-Sided|95.0|0.11|1.41|||Expl. Cox Proportional Hazards Model||||
1624920|NCT02234622|2984101|Superiority||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.4||0.668|2-Sided|95.0|-0.5|1.0|||Mixed Models Analysis||||
1624921|NCT02234622|2984102|Superiority||Mean Difference (Final Values)|-2.4|Standard Error of the Mean|1.8||0.367|2-Sided|95.0|-6.0|1.1|||Mixed Models Analysis||||
1624922|NCT02234622|2984103|Superiority||Mean Difference (Final Values)|-1.4|Standard Error of the Mean|1.7||0.635|2-Sided|95.0|-4.7|1.9|||Mixed Models Analysis||||
1624923|NCT02234622|2984104|Superiority||Mean Difference (Final Values)|-1.5|Standard Error of the Mean|1.4||0.482|2-Sided|95.0|-4.2|1.1|||Mixed Models Analysis||||
1624924|NCT02234622|2984105|Superiority||Mean Difference (Final Values)|-6.7|Standard Error of the Mean|2.6||0.042|2-Sided|95.0|-11.9|-1.6|||Mixed Models Analysis||||
1624925|NCT02234622|2984106|Superiority||Mean Difference (Net)|-6.1|Standard Error of the Mean|2.2||0.005|2-Sided|95.0|-10.3|-1.8|||Mixed Models Analysis||||
1624926|NCT02234622|2984107|Superiority||Mean Difference (Final Values)|-5.0|Standard Error of the Mean|1.6||0.002|2-Sided|95.0|-8.2|-1.8|||Mixed Models Analysis||||
1624927|NCT02234427|2984118|Superiority or Other||||||<|5e-06||||||Above noted p-value is adjusted for multiple comparisons. Analysis was performed using the TopHat/Cufflinks pipeline. The differential expression algorithm uses a beta distribution and the overdispersion with a negative binomial distribution.|negative binomial|||Null Hypothesis: There is no difference in gene expression before and after aspirin therapy|
1624928|NCT02234284|2984133|Superiority||Mean Difference (Final Values)|14.6||||0.01|2-Sided|95.0|3.3|25.9|||Mixed Models Analysis||Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624929|NCT02234284|2984134|Superiority||difference in proportion|-18.9||||0.01|2-Sided|95.0|-33.1|-4.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624930|NCT02234284|2984135|Superiority||Mean Difference (Final Values)|-0.08||||0.37|2-Sided|95.0|-0.2|0.04|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of non-COPD-related hospitalizations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624931|NCT02234284|2984136|Superiority||Mean Difference (Final Values)|-0.13||||0.35|2-Sided|95.0|-0.32|0.06|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of COPD-related hospital visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624932|NCT02234284|2984137|Superiority||Mean Difference (Final Values)|-0.08||||0.8|2-Sided|95.0|-0.56|0.4|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of non-COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624933|NCT02234284|2984138|Superiority||Mean Difference (Final Values)|-0.05||||0.78|2-Sided|95.0|-0.32|0.22|||Mixed Models Analysis||Value is for rate of COPD-related ED visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624934|NCT02234284|2984139|Superiority||Mean Difference (Final Values)|0.48||||0.52|2-Sided|95.0|-0.32|1.28|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of outpatient visits for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624935|NCT02234284|2984140|Superiority||Mean Difference (Final Values)|0.1||||0.97|2-Sided|95.0|-5.5|5.3|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624936|NCT02234284|2984141|Superiority||Mean Difference (Final Values)|3.4||||0.7|2-Sided|95.0|-14.0|20.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624937|NCT02234284|2984142|Superiority||Median Difference (Final Values)|2.0||||0.73|2-Sided|95.0|-9.4|13.4|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.||Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624938|NCT02234284|2984143|Superiority||Mean Difference (Final Values)|7.8||||0.38|2-Sided|95.0|-9.5|25.2|||Mixed Models Analysis||Value is for proportion of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624939|NCT02234284|2984144|Superiority||Mean Difference (Final Values)|39.7|||<|0.001|2-Sided|95.0|19.6|59.8|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1625172|NCT02229396|2984664|Superiority or Other||Difference in percentages|25.6|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (<9.0% or ≥9.0%).|||
1624940|NCT02234284|2984145|Superiority||Mean Difference (Final Values)|-0.73||||0.29|2-Sided|95.0|-2.07|0.62|||Mixed Models Analysis||Value is for mean number of days for participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.||
1624941|NCT02234284|2984146|Superiority||Mean Difference (Final Values)|-11.5||||0.3|2-Sided|95.0|-33.3|10.2|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for proportion (%) of participants in Health Coached arm minus proportion in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624942|NCT02234284|2984147|Superiority||Mean Difference (Net)|0.0||||0.98|2-Sided|95.0|-3.0|3.0|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean percent predicted of participants in Health Coached arm minus mean percent predicted in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624943|NCT02234284|2984148|Superiority||Mean Difference (Final Values)|-0.83||||0.4|2-Sided|95.0|-2.78|1.12|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624944|NCT02234284|2984149|Superiority||Mean Difference (Final Values)|0.38||||0.02|2-Sided|95.0|0.07|0.68|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624945|NCT02234284|2984150|Superiority||Mean Difference (Final Values)|0.3||||0.27|2-Sided|95.0|-0.23|0.83|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624946|NCT02234284|2984151|Superiority||Mean Difference (Final Values)|8.53||||0.32|2-Sided|95.0|-8.18|25.26|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.||Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|Value is for mean distance (in meters) of participants in Health Coached arm minus mean distance in Usual Care, adjusted for baseline values and for clustering.
1624947|NCT02234284|2984152|Superiority||Mean Difference (Final Values)|-0.21||||0.13|2-Sided|95.0|-0.49|0.07|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for rate of exacerbations for participants in Health Coached arm minus rate for Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624948|NCT02234284|2984153|Superiority||Mean Difference (Net)|0.26||||0.2|2-Sided|95.0|-0.13|0.65|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624981|NCT02233517|2984319|Superiority||Mean Difference (Net)|0.28|Standard Error of the Mean|0.37||0.45|2-Sided||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.||
1625449|NCT02223364|2985265|Superiority|||||||0.958|||||||Wilcoxon (Mann-Whitney)||||
1624949|NCT02234284|2984154|Superiority||Mean Difference (Final Values)|0.14||||0.35|2-Sided|95.0|-0.15|0.43|||Mixed Models Analysis|Outcomes were by group assignment (intention to treat) using generalized linear models adjusted for baseline levels of variable and clustering.|Value is for mean score of participants in Health Coached arm minus mean score in Usual Care, adjusted for baseline values and for clustering.|Outcomes were compared by group assignment using generalized linear models (GLMs) with a normal distribution for continuous outcomes), Poisson distribution for count outcomes (e.g. exacerbations and hospitalizations), and binomial distribution for binary outcomes. In all models, baseline levels of the outcome were entered as a predictor and follow-up levels as the dependent variable, with use of a robust standard error to account for clustering.|
1624950|NCT02234141|2984176|Other|Nonparametric pairwise comparison|||||=|0||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test)|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable [yes/no] and the number of background PAH therapies they were receiving [1, 2, or ≥ 3]).|
1624951|NCT02234141|2984176|Other|Nonparametric pairwise comparison|||||=|0||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test).|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable [yes/no] and the number of background PAH therapies they were receiving [1, 2, or ≥ 3]).|
1624952|NCT02234141|2984176|Other|Nonparametric pairwise comparison|||||=|0||||||P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test).|gvE/vE|||The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable [yes/no] and the number of background PAH therapies they were receiving {1, 2, or greater than or equal to [≥] 3}).|
1624953|NCT02233998|2984180|Superiority or Other||Hodges-Lehmann estimate of difference|15.939|||<|0.001|2-Sided|95.0|12.5|18.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.|
1624954|NCT02233998|2984180|Superiority or Other||Hodges-Lehmann estimate of difference|19.048|||<|0.001|2-Sided|95.0|15.94|21.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.|
1624955|NCT02233998|2984181|Superiority or Other||Hodges-Lehmann estimate of difference|18.59|||<|0.001|2-Sided|95.0|13.69|23.81||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.|
1624956|NCT02233998|2984181|Superiority or Other||Hodges-Lehmann estimate of difference|23.214|||<|0.001|2-Sided|95.0|18.21|28.77||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.|
1624957|NCT02233998|2984182|Superiority or Other||Hodges-Lehmann estimate of difference|0.926||||0.197|2-Sided|95.0|-0.16|1.85||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.|
1624958|NCT02233998|2984182|Superiority or Other||Hodges-Lehmann estimate of difference|1.316||||0.016|2-Sided|95.0|0.0|2.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.|
1624959|NCT02233998|2984183|Superiority or Other||Hodges-Lehmann estimate of difference|1.19|||<|0.001|2-Sided|95.0|0.93|2.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.|
1624960|NCT02233998|2984183|Superiority or Other||Hodges-Lehmann estimate of difference|2.05|||<|0.001|2-Sided|95.0|1.3|2.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.|
1624961|NCT02233998|2984184|Superiority or Other||Hodges-Lehmann estimate of difference|15.939|||<|0.001|2-Sided|95.0|12.5|18.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.|
1625007|NCT02232698|2984351|Superiority or Other||Mean Difference (Final Values)|1.0|Standard Error of the Mean|0.3||0.0006|2-Sided||||||ANCOVA||||
1625008|NCT02232698|2984352|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.163||0.0247|2-Sided||||||ANCOVA|||Statistical analysis for time spent >240 mg/dL|
1624962|NCT02233998|2984184|Superiority or Other||Hodges-Lehmann estimate of difference|19.048|||<|0.001|2-Sided|95.0|15.94|21.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.|
1624963|NCT02233998|2984185|Superiority or Other||Hodges-Lehmann estimate of difference|19.444|||<|0.001|2-Sided|95.0|17.09|22.22||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.|
1624964|NCT02233998|2984185|Superiority or Other||Hodges-Lehmann estimate of difference|23.24|||<|0.001|2-Sided|95.0|20.75|25.85||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Wilcoxon Rank Sum Test|P-values were based on Wilcoxon Rank Sum Test on the change from baseline.|95% Confidence limits for the location shift.|The null hypothesis was no difference between treatment groups. The alternative hypothesis was a difference between treatment groups.|
1624965|NCT02233998|2984186|Superiority or Other||Least Squares Mean Difference|-0.026|Standard Error of the Mean|0.0059|<|0.001|2-Sided|95.0|-0.038|-0.014||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1624966|NCT02233998|2984186|Superiority or Other||Least Squares Mean Difference|-0.03|Standard Error of the Mean|0.006|<|0.001|2-Sided|95.0|-0.042|-0.019||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment with baseline whole mouth mean gingival bleeding index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1624967|NCT02233998|2984187|Superiority or Other||Least Squares Mean Difference|-0.379|Standard Error of the Mean|0.0286|<|0.001|2-Sided|95.0|-0.435|-0.322||Per statistical analysis plan, Hochberg’s method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean plaque index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1624968|NCT02233998|2984187|Superiority or Other||Least Squares Mean Difference|-0.469|Standard Error of the Mean|0.0286|<|0.001|2-Sided|95.0|-0.526|-0.413||Per statistical analysis plan, Hochberg’s method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean plaque index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1624969|NCT02233998|2984188|Superiority or Other||Least Squares Mean Difference|-0.197|Standard Error of the Mean|0.0161|<|0.001|2-Sided|95.0|-0.228|-0.165||Per statistical analysis plan, Hochberg’s method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1624970|NCT02233998|2984188|Superiority or Other||Least Squares Mean Difference|-0.234|Standard Error of the Mean|0.0162|<|0.001|2-Sided|95.0|-0.266|-0.202||Per statistical analysis plan, Hochberg’s method at significance level 0.05 was applied to jointly evaluate Whole Mouth Mean MGI at Wk 3 and Whole Mouth Mean PI at Wk 3 for both Listerine rinses vs control. Family-wise error controlled at 0.05.|ANCOVA|Terms included treatment with baseline whole mouth mean modified gingival index as a covariate.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1624971|NCT02233803|2984197|Superiority or Other||Difference of LS means|0.6|||||2-Sided|95.0|0.1|1.1|||||||
1624972|NCT02233803|2984198|Superiority or Other||Difference of LS means|0.98|||||2-Sided|95.0|0.576|1.384|||||||
1624973|NCT02233803|2984199|Non-Inferiority or Equivalence|Non-inferiority (NI) is demonstrated as the lower limit of CI for the difference is greater than the pre-specified NI margin of -1.25ML. The lower limit of the 95% CI for the treatment difference (NEUMOTEROL 400 -Symbicort Forte) was greater than the pre-specified non-inferiority margin of -1.25 mL.|Difference of LS means|0.044|||||2-Sided|95.0|-0.008|0.096||||||Sample size calculations are based on the primary efficacy endpoint (change from baseline in trough FEV1 at day 29). Assuming a within-subject standard deviation of 210 mL, 168 completed subjects are required to demonstrate the non-inferiority of BFF 400/12 mcg SINGLE CAPSULE INHALER and BFF 320/9 mcg TURBUHALER BID, assuming a true difference of -50 mL with 90% power and a 2.5% one-sided significance level. The pre-specified NI margin is set at -1.25mL.|
1624974|NCT02233543|2984316|Superiority or Other||Mean Difference (Net)|7.79||||0.2016|2-Sided|95.0|-4.51|20.08|||Mixed Models Analysis||||
1624975|NCT02233543|2984317|Superiority or Other||Mean Difference (Net)|-0.44||||0.2419|2-Sided|95.0|-1.21|0.32|||Mixed Models Analysis||||
1624976|NCT02233517|2984318|Superiority||Mean Difference (Net)|-0.78|Standard Error of the Mean|1.04||0.45|2-Sided||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.||
1624977|NCT02233517|2984318|Superiority||Mean Difference (Net)|-0.41|Standard Error of the Mean|1.04||0.7|2-Sided||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.||
1624978|NCT02233517|2984318|Superiority||Mean Difference (Net)|-0.71|Standard Error of the Mean|1.04||0.49|2-Sided||||||Mixed Models Analysis||Baseline to post-treatment.||
1624979|NCT02233517|2984319|Superiority||Mean Difference (Net)|0.06|Standard Error of the Mean|0.37||0.87|2-Sided||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.||
1624982|NCT02233517|2984320|Superiority||Mean Difference (Net)|0.17|Standard Error of the Mean|0.12||0.16|2-Sided||||||Mixed Models Analysis||Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in PTSD in PCT).|Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on PCL Total scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.|
1624983|NCT02233517|2984321|Superiority||Mean Difference (Net)|-1.06|Standard Error of the Mean|0.66||0.11|2-Sided||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.||
1624984|NCT02233517|2984321|Superiority||Mean Difference (Net)|-0.52|Standard Error of the Mean|0.66||0.44|2-Sided||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.||
1624985|NCT02233517|2984321|Superiority||Mean Difference (Net)|-0.71|Standard Error of the Mean|0.66||0.29|2-Sided||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.||
1624986|NCT02233517|2984322|Superiority||Mean Difference (Net)|0.07|Standard Error of the Mean|0.17||0.69|2-Sided||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.||
1624987|NCT02233517|2984322|Superiority||Mean Difference (Net)|0.006|Standard Error of the Mean|0.16||0.97|2-Sided||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.||
1624988|NCT02233517|2984322|Superiority||Mean Difference (Net)|-0.19|Standard Error of the Mean|0.16||0.25|2-Sided||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.||
1624989|NCT02233517|2984323|Superiority||Mean Difference (Net)|-0.89|Standard Error of the Mean|2.71||0.74|2-Sided||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.||
1624990|NCT02233517|2984323|Superiority||Mean Difference (Net)|1.37|Standard Error of the Mean|2.71||0.61|2-Sided||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.||
1624991|NCT02233517|2984323|Superiority||Mean Difference (Net)|1.45|Standard Error of the Mean|2.71||0.59|2-Sided||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.||
1624992|NCT02233517|2984324|Superiority||Mean Difference (Net)|0.28|Standard Error of the Mean|0.06|<|0.0001|2-Sided||||||Mixed Models Analysis||The estimation parameter of 0.28 indicates that at each of the 16 time points, participants in the CBT arm had 0.28 point less of a decrease in disability than those in PCT arm.|Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in anger over time in PCT).|
1624993|NCT02233517|2984325|Superiority||Mean Difference (Net)|-0.58|Standard Deviation|2.42||0.5|2-Sided|95.0|-2.3|1.14|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Satisfaction scale.|
1624994|NCT02233517|2984325|Superiority||Mean Difference (Net)|-0.47|Standard Deviation|2.09||0.53|2-Sided|95.0|-2.03|1.08|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Perceived Limitations scale.|
1624995|NCT02233517|2984325|Superiority||Mean Difference (Net)|-2.3|Standard Deviation|3.2||0.05|2-Sided|95.0|-4.5|-0.002|||t-test, 2 sided|||This is the comparison of change in means for cognitive-behavioral vs. present-centered therapy from baseline to post-treatment for the Extent of Participation scale.|
1624996|NCT02233517|2984326|Superiority||Mean Difference (Net)|0.31|Standard Error of the Mean|1.16||0.79|2-Sided||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.||
1624997|NCT02233517|2984326|Superiority||Mean Difference (Net)|0.22|Standard Error of the Mean|1.16||0.85|2-Sided||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.||
1624998|NCT02233517|2984326|Superiority||Mean Difference (Net)|-0.14|Standard Error of the Mean|1.16||0.9|2-Sided||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.||
1624999|NCT02233517|2984327|Superiority|Estimation parameter is interaction of session by therapy, or estimate of difference in mean between CBT and PCT per time point. Positive value is less decrease over time in CBT arm (greater decrease in anger over time in PCT).|Mean Difference (Net)|0.11|Standard Error of the Mean|0.1||0.26|2-Sided||||||Mixed Models Analysis|||Multilevel model of therapy type (1=CBT, 2=PCT), gender, and time on DAR scores, using data from baseline, 12 sessions, post-treatment, 3-month and 6-month follow up.|
1625000|NCT02233517|2984328|Superiority||Slope|0.5|Standard Error of the Mean|0.51||0.33|2-Sided||||||Mixed Models Analysis||Baseline to 6 months post-treatment. The reference condition is the present centered therapy arm.||
1625001|NCT02233517|2984328|Superiority||Slope|0.23|Standard Error of the Mean|0.52|<|0.44|2-Sided||||||Mixed Models Analysis||Baseline to 3 months post-treatment. The reference condition is the present centered therapy arm.||
1625002|NCT02233517|2984328|Superiority||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.51|<|0.84|2-Sided||||||Mixed Models Analysis||Baseline to post-treatment. The reference condition is the present centered therapy arm.||
1625003|NCT02233478|2984329|Other||Mean Difference (Final Values)|0.001||||0.82|2-Sided||||||t-test, 2 sided|||"Comparison of ellagic acid concentration 0 to 24 hours post-dose area under the curve was made to PJ alone vs. PJ with soy protein after intervention.~Due to the quality issue of soybean flour, data from this intervention group was not analyzed."|
1625004|NCT02232698|2984348|Superiority or Other||Mean Difference (Final Values)|6.1|Standard Error of the Mean|0.84|<|0.0001|2-Sided||||||ANCOVA|||Statistical analysis of total treatment satisfaction score|
1625005|NCT02232698|2984348|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.22|<|0.0713|2-Sided||||||ANCOVA|||Statistical analysis of perceived frequency of hypoglycaemia|
1625006|NCT02232698|2984348|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.22|<|0.0001|2-Sided||||||ANCOVA|||Statistical analysis of perceived frequency of hyperglycaemia|
1625450|NCT02223364|2985266|Superiority|||||||0.357|||||||Wilcoxon (Mann-Whitney)||||
1625010|NCT02232698|2984353|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.05|<|0.0001|2-Sided||||||ANCOVA|||Statistical analysis of frequency of episodes <40 mg/dL|
1625011|NCT02232698|2984353|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.074|<|0.0001|2-Sided||||||ANCOVA|||Statistical analysis of frequency of episodes <55 mg/dL|
1625012|NCT02232698|2984353|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.089|<|0.0001|2-Sided||||||ANCOVA|||Statistical analysis of frequency of episodes <70 mg/dL|
1625013|NCT02232698|2984354|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.122||0.0003|2-Sided|||||Statistical analysis of time spent <40 mg/dL|ANCOVA||||
1625014|NCT02232698|2984354|Superiority or Other||Mean Difference (Final Values)|-0.82|Standard Error of the Mean|0.175|<|0.0001|2-Sided|||||Statistical analysis of time spent <55 mg/dL|ANCOVA||||
1625015|NCT02232698|2984355|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.059||0.9556|2-Sided||||||ANCOVA||||
1625016|NCT02232698|2984356|Superiority or Other||Mean Difference (Final Values)|-1.24|Standard Error of the Mean|0.239|<|0.0001|2-Sided||||||ANCOVA||||
1625017|NCT02232074|2984378|Superiority||Mean Difference (Final Values)|0.97|Standard Deviation|3.7||0.8|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear||||
1625018|NCT02232074|2984379|Superiority||Mean Difference (Final Values)|1.14|Standard Deviation|0.75||0.13|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear||||
1625019|NCT02232074|2984380|Superiority||Mean Difference (Final Values)|-4.83|Standard Deviation|2.93||0.16|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear||||
1625020|NCT02232074|2984381|Superiority||Mean Difference (Final Values)|2.38|Standard Deviation|1.66||0.16|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear||||
1625021|NCT02232074|2984382|Superiority||Median Difference (Final Values)|-0.03|Standard Deviation|0.2||0.89|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear||||
1625022|NCT02232074|2984383|Superiority||Mean Difference (Final Values)|0.06|Standard Deviation|0.08||0.46|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear||||
1625023|NCT02232074|2984384|Superiority||Median Difference (Final Values)|-1.45|Standard Deviation|2.71||0.61|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear|||We hypothesize that compared to the control group, the Lung cancer INTERVENTION group will have less distress at 12 months post-enrollment|
1625024|NCT02232074|2984385|Superiority||Median Difference (Final Values)|0.19|Standard Error of the Mean|0.5||0.71|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear|||We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will have less distress at 12 months post-enrollment.|
1625025|NCT02232074|2984386|Superiority||Odds Ratio (OR)|0.85||||0.79|2-Sided|95.0|0.28|2.79||a priori threshold for statistical significance p<0.05|Regression, Logistic|||We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will receive quality care (i.e. receipt of radiation within one year of diagnosis).|
1625026|NCT02232074|2984387|Superiority||Median Difference (Final Values)|4.2|Standard Error of the Mean|2.21||0.09|2-Sided||||||Regression, Linear|adjusting for baseline Case scores.||Compared to the control group, the lung cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.|
1625027|NCT02232074|2984388|Superiority||Median Difference (Final Values)|0.33|Standard Error of the Mean|0.59||0.58|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear|adjusting for baseline Case scores.||Compared to the control group, the breast cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.|
1625028|NCT02232074|2984389|Superiority||Median Difference (Final Values)|1.25|Standard Error of the Mean|2.91||0.69|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear|||Compared to the control group, the Lung cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment|
1625029|NCT02232074|2984390|Superiority||Median Difference (Final Values)|0.71|Standard Error of the Mean|1.43||0.62|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear|||Compared to the control group, the Breast cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment|
1625030|NCT02232074|2984391|Superiority||Median Difference (Final Values)|-0.18|Standard Error of the Mean|0.15||0.26|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear||||
1625031|NCT02232074|2984392|Superiority||Median Difference (Final Values)|0.03|Standard Error of the Mean|0.07||0.68|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear||||
1625032|NCT02232074|2984393|Superiority||Median Difference (Final Values)|-1.33|Standard Error of the Mean|1.29||0.33|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Lung cancer INTERVENTION group will have less distress at 6 months post-enrollment|
1625033|NCT02232074|2984394|Superiority||Median Difference (Final Values)|-0.6|Standard Error of the Mean|0.45||0.18|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 6 months post-enrollment|
1625034|NCT02232074|2984395|Superiority||Median Difference (Final Values)|-1.32|Standard Error of the Mean|1.62||0.43|2-Sided|||||Adjusting for baseline Distress Thermometer scores.|Regression, Linear|||Compared to the control group, the LUNG cancer INTERVENTION group will have less distress at 3 months post-enrollment|
1625035|NCT02232074|2984396|Superiority||Median Difference (Final Values)|-0.27|Standard Error of the Mean|0.42||0.53|2-Sided|||||a priori threshold for statistical significance p<0.05|Regression, Linear|Adjusting for baseline Distress Thermometer scores.||Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 3 months post-enrollment|
1625036|NCT02232074|2984397|Superiority||Odds Ratio (OR)|4.0||||0.26|2-Sided|95.0|0.35|45.4||a priori threshold for statistical significance p<0.05|Regression, Logistic|||Compared to the control group, the Lung cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).|
1625037|NCT02232074|2984398|Superiority||Odds Ratio (OR)|0.82||||0.77|2-Sided|95.0|0.21|3.14||a priori threshold for statistical significance p<0.05|Regression, Logistic|||Compared to the control group, the Breast cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).|
1625038|NCT02231749|2984449|Superiority||Hazard Ratio (HR)|0.98||||0.8498|2-Sided|99.1|0.79|1.23|||Log Rank||||
1625039|NCT02231749|2984450|Superiority||Hazard Ratio (HR)|0.68||||0.0003|2-Sided|99.8|0.49|0.95|||Log Rank||||
1625040|NCT02231749|2984451|Superiority||Stratified Difference|7.2||||0.0191|2-Sided|95.0|1.8|12.7|||DerSimonian and Laird Test||||
1625041|NCT02231749|2984452|Superiority||Hazard Ratio (HR)|0.82||||0.0331|2-Sided|99.1|0.64|1.05|||Log Rank||||
1625042|NCT02231749|2984453|Superiority||Hazard Ratio (HR)|0.63|||<|0.0001|2-Sided|99.8|0.44|0.89|||Log Rank||||
1625043|NCT02231749|2984454|Superiority||Stratified Difference|16.0|||<|0.0001|2-Sided|95.0|9.8|22.2|||DerSimonian and Laird Test||||
1625044|NCT02231580|2984455|Superiority or Other||GLS mean ratio|0.853|||=|0|2-Sided|90.0|0.64|1.136|||MMRM|||Right foot freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625045|NCT02231580|2984455|Superiority or Other||GLS mean ratio|0.699|||=|0|2-Sided|90.0|0.53|0.922|||MMRM|||Left foot freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625046|NCT02231580|2984456|Superiority or Other||GLS mean ratio|1.158|||=|0|2-Sided|90.0|0.84|1.595|||MMRM|||Right foot TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625047|NCT02231580|2984456|Superiority or Other||GLS mean ratio|1.392|||=|0|2-Sided|90.0|0.997|1.943|||MMRM|||Left foot TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625048|NCT02231580|2984457|Superiority or Other||GLS mean ratio|1.074|||=|0|2-Sided|90.0|0.758|1.523|||MMRM|||Right foot ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625049|NCT02231580|2984457|Superiority or Other||GLS mean ratio|1.387|||=|0|2-Sided|90.0|0.994|1.935|||MMRM|||Left foot ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625050|NCT02231580|2984457|Superiority or Other||GLS mean ratio|1.462|||=|0|2-Sided|90.0|0.85|2.515|||MMRM|||Right foot ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625051|NCT02231580|2984457|Superiority or Other||GLS mean ratio|1.914|||=|0|2-Sided|90.0|1.167|3.141|||MMRM|||Left foot ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625052|NCT02231580|2984458|Superiority or Other||GLS mean ratio|1.269|||=|0|2-Sided|90.0|0.856|1.884|||MMRM|||Right foot IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625053|NCT02231580|2984458|Superiority or Other||GLS mean ratio|1.564|||=|0|2-Sided|90.0|1.144|2.138|||MMRM|||Left foot IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625054|NCT02231580|2984458|Superiority or Other||GLS mean ratio|1.21|||=|0|2-Sided|90.0|0.686|2.133|||MMRM|||Right foot IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625055|NCT02231580|2984458|Superiority or Other||GLS mean ratio|2.272|||=|0|2-Sided|90.0|1.381|3.737|||MMRM|||Left foot IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625118|NCT02231177|2984500|Superiority or Other||Geometric Mean Ratio|1.05|Standard Deviation|19.85|||2-Sided|90.0|0.98|1.13|||||The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.|
1625056|NCT02231580|2984459|Superiority or Other||GLS mean ratio|1.454|||=|0|2-Sided|90.0|0.789|2.679|||MMRM|||Right foot TD duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625057|NCT02231580|2984459|Superiority or Other||GLS mean ratio|1.598|||=|0|2-Sided|90.0|0.98|2.608|||MMRM|||Left foot TD duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625058|NCT02231580|2984459|Superiority or Other||GLS mean ratio|1.687|||=|0|2-Sided|90.0|0.762|3.737|||MMRM|||Right foot TD variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625059|NCT02231580|2984459|Superiority or Other||GLS mean ratio|1.911|||=|0|2-Sided|90.0|1.017|3.592|||MMRM|||Left foot TD variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625060|NCT02231580|2984460|Superiority or Other||GLS mean ratio|1.251|||=|0|2-Sided|90.0|0.825|1.899|||MMRM|||Right foot IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625061|NCT02231580|2984460|Superiority or Other||GLS mean ratio|1.56|||=|0|2-Sided|90.0|1.139|2.137|||MMRM|||Left foot IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625062|NCT02231580|2984460|Superiority or Other||GLS mean ratio|1.274|||=|0|2-Sided|90.0|0.688|2.361|||MMRM|||Right foot IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625063|NCT02231580|2984460|Superiority or Other||GLS mean ratio|2.163|||=|0|2-Sided|90.0|1.295|3.614|||MMRM|||Left foot IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625064|NCT02231580|2984461|Superiority or Other||GLS mean ratio|0.919|||=|0|2-Sided|90.0|0.789|1.069|||MMRM|||Right hand freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625065|NCT02231580|2984461|Superiority or Other||GLS mean ratio|0.879|||=|0|2-Sided|90.0|0.765|1.009|||MMRM|||Left hand freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625066|NCT02231580|2984462|Superiority or Other||GLS mean ratio|0.978|||=|0|2-Sided|90.0|0.778|1.229|||MMRM|||Right hand TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625067|NCT02231580|2984462|Superiority or Other||GLS mean ratio|0.93|||=|0|2-Sided|90.0|0.755|1.147|||MMRM|||Left hand TF variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625068|NCT02231580|2984463|Superiority or Other||GLS mean ratio|1.138|||=|0|2-Sided|90.0|0.976|1.327|||MMRM|||Right hand ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625069|NCT02231580|2984463|Superiority or Other||GLS mean ratio|1.193|||=|0|2-Sided|90.0|1.038|1.371|||MMRM|||Left hand ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625070|NCT02231580|2984463|Superiority or Other||GLS mean ratio|1.18|||=|0|2-Sided|90.0|0.644|2.162|||MMRM|||Right hand ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625272|NCT02227784|2984842|Superiority or Other (legacy)||Median Difference (Final Values)|-7.05|||<|0.001|2-Sided|95.0|-11.5|-2.68|||Mixed Models Analysis||||
1625071|NCT02231580|2984463|Superiority or Other||GLS mean ratio|1.571|||=|0|2-Sided|90.0|1.018|2.424|||MMRM|||Left hand ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625072|NCT02231580|2984464|Superiority or Other||GLS mean ratio|1.059|||=|0|2-Sided|90.0|0.897|1.25|||MMRM|||Right hand IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625073|NCT02231580|2984464|Superiority or Other||GLS mean ratio|1.115|||=|0|2-Sided|90.0|0.965|1.289|||MMRM|||Left hand IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625074|NCT02231580|2984464|Superiority or Other||GLS mean ratio|0.815|||=|0|2-Sided|90.0|0.444|1.496|||MMRM|||Right hand IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625075|NCT02231580|2984464|Superiority or Other||GLS mean ratio|1.14|||=|0|2-Sided|90.0|0.677|1.917|||MMRM|||Left hand IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625076|NCT02231580|2984465|Superiority or Other||GLS mean ratio|0.847|||=|0|2-Sided|90.0|0.561|1.277|||MMRM|||Right hand duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625077|NCT02231580|2984465|Superiority or Other||GLS mean ratio|1.018|||=|0|2-Sided|90.0|0.752|1.378|||MMRM|||Left hand duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625078|NCT02231580|2984465|Superiority or Other||GLS mean ratio|0.612|||=|0|2-Sided|90.0|0.292|1.283|||MMRM|||Right hand variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625079|NCT02231580|2984465|Superiority or Other||GLS mean ratio|0.929|||=|0|2-Sided|90.0|0.529|1.63|||MMRM|||Left hand variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625080|NCT02231580|2984466|Superiority or Other||GLS mean ratio|1.046|||=|0|2-Sided|90.0|0.886|1.234|||MMRM|||Right hand IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625081|NCT02231580|2984466|Superiority or Other||GLS mean ratio|1.119|||=|0|2-Sided|90.0|0.967|1.294|||MMRM|||Left hand IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625082|NCT02231580|2984466|Superiority or Other||GLS mean ratio|0.759|||=|0|2-Sided|90.0|0.411|1.399|||MMRM|||Right hand IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625083|NCT02231580|2984466|Superiority or Other||GLS mean ratio|1.168|||=|0|2-Sided|90.0|0.697|1.955|||MMRM|||Left hand IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625084|NCT02231580|2984467|Superiority or Other||GLS mean ratio|0.967|||=|0|2-Sided|90.0|0.856|1.093|||MMRM|||Right finger freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625085|NCT02231580|2984467|Superiority or Other||GLS mean ratio|0.812|||=|0|2-Sided|90.0|0.706|0.935|||MMRM|||Left finger freq statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625273|NCT02227784|2984842|Superiority or Other (legacy)||Median Difference (Final Values)|-22.02|||<|0.001|2-Sided|95.0|-28.4|-15.9|||Mixed Models Analysis||||
1625086|NCT02231580|2984468|Superiority or Other||GLS mean ratio|0.966|||=|0|2-Sided|90.0|0.765|1.22|||MMRM|||Right finger TF statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625087|NCT02231580|2984468|Superiority or Other||GLS mean ratio|1.198|||=|0|2-Sided|90.0|0.96|1.494|||MMRM|||Left finger TF statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625088|NCT02231580|2984469|Superiority or Other||GLS mean ratio|1.014|||=|0|2-Sided|90.0|0.837|1.229|||MMRM|||Right finger ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625089|NCT02231580|2984469|Superiority or Other||GLS mean ratio|1.298|||=|0|2-Sided|90.0|1.043|1.614|||MMRM|||Left finger ITI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625090|NCT02231580|2984469|Superiority or Other||GLS mean ratio|0.916|||=|0|2-Sided|90.0|0.63|1.333|||MMRM|||Right finger ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625091|NCT02231580|2984469|Superiority or Other||GLS mean ratio|1.657|||=|0|2-Sided|90.0|1.086|2.529|||MMRM|||Left finger ITI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625092|NCT02231580|2984470|Superiority or Other||GLS mean ratio|1.042|||=|0|2-Sided|90.0|0.915|1.186|||MMRM|||Right finger IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625093|NCT02231580|2984470|Superiority or Other||GLS mean ratio|1.242|||=|0|2-Sided|90.0|1.077|1.433|||MMRM|||Left finger IPI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625094|NCT02231580|2984470|Superiority or Other||GLS mean ratio|0.886|||=|0|2-Sided|90.0|0.605|1.299|||MMRM|||Right finger IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625095|NCT02231580|2984470|Superiority or Other||GLS mean ratio|1.618|||=|0|2-Sided|90.0|1.124|2.331|||MMRM|||Left finger IPI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625096|NCT02231580|2984471|Superiority or Other||GLS mean ratio|1.045|||=|0|2-Sided|90.0|0.875|1.248|||MMRM|||Right finger duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625097|NCT02231580|2984471|Superiority or Other||GLS mean ratio|1.15|||=|0|2-Sided|90.0|0.934|1.416|||MMRM|||Left finger duration of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625098|NCT02231580|2984471|Superiority or Other||GLS mean ratio|1.177|||=|0|2-Sided|90.0|0.804|1.722|||MMRM|||Right finger variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625099|NCT02231580|2984471|Superiority or Other||GLS mean ratio|1.308|||=|0|2-Sided|90.0|0.85|2.014|||MMRM|||Left finger variability of TD statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625100|NCT02231580|2984472|Superiority or Other||GLS mean ratio|1.038|||=|0|2-Sided|90.0|0.912|1.182|||MMRM|||Right finger IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625274|NCT02227784|2984842|Superiority or Other (legacy)||Median Difference (Final Values)|-26.47|||<|0.001|2-Sided|95.0|-33.4|-20.0|||Mixed Models Analysis||||
1625101|NCT02231580|2984472|Superiority or Other||GLS mean ratio|1.238|||=|0|2-Sided|90.0|1.074|1.426|||MMRM|||Left finger IOI duration statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625102|NCT02231580|2984472|Superiority or Other||GLS mean ratio|0.953|||=|0|2-Sided|90.0|0.662|1.372|||MMRM|||Right finger IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625103|NCT02231580|2984472|Superiority or Other||GLS mean ratio|1.509|||=|0|2-Sided|90.0|1.06|2.15|||MMRM|||Left finger IOI variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625104|NCT02231580|2984473|Superiority or Other||GLS mean ratio|0.686|||=|0|2-Sided|90.0|0.508|0.925|||MMRM|||Right hand isometric grip forces statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625105|NCT02231580|2984473|Superiority or Other||GLS mean ratio|0.693|||=|0|2-Sided|90.0|0.487|0.985|||MMRM|||Left hand isometric grip forces statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625106|NCT02231580|2984474|Superiority or Other||GLS mean ratio|1.16|||=|0|2-Sided|90.0|0.781|1.724|||MMRM|||Right hand grip force variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625107|NCT02231580|2984474|Superiority or Other||GLS mean ratio|1.247|||=|0|2-Sided|90.0|0.886|1.756|||MMRM|||Left hand grip force variability statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625108|NCT02231580|2984475|Superiority or Other||GLS mean ratio|1.093|||=|0|2-Sided|90.0|0.8|1.493|||MMRM|||Right hand orientation-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625109|NCT02231580|2984475|Superiority or Other||GLS mean ratio|1.035|||=|0|2-Sided|90.0|0.675|1.587|||MMRM|||Left hand orientation-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625110|NCT02231580|2984476|Superiority or Other||GLS mean ratio|1.141|||=|0|2-Sided|90.0|0.862|1.51|||MMRM|||Right hand position-index statistical analysis is presented (BN82451B versus Placebo). The MMRM analysis was performed on log-transformed data using the REML model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625111|NCT02231580|2984476|Superiority or Other||GLS mean ratio|1.104|||=|0|2-Sided|90.0|0.823|1.482|||MMRM|||Left hand position-index statistical analysis is presented (BN82451B versus Placebo). The Mixed Effect Model Repeat Measurement (MMRM) analysis was performed on log-transformed data using the restricted maximum likelihood (REML) model including fixed categorical effects of treatment/cohort group, visit and treatment/cohort by visit interaction as well as the continuous fixed covariate of baseline value. Cohort was fitted as random effect.|
1625112|NCT02231177|2984494|Superiority or Other||Geometric Mean Ratio|0.99|Standard Deviation|72.08|||2-Sided|90.0|0.79|1.24|||||The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg; Tiotropium 5 µg). No formal testing.|
1625113|NCT02231177|2984495|Superiority or Other||Geometric mean ratio|1.32|Standard Deviation|96.12|||2-Sided|90.0|0.98|1.77|||||The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg; Olodaterol 10 µg). No formal testing.|
1625114|NCT02231177|2984496|Superiority or Other||Geometric Mean Ratio|0.91|Standard Deviation|22.61|||2-Sided|90.0|0.84|1.0|||||The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg : Tiotropium 5 µg). No formal testing.|
1625115|NCT02231177|2984497|Superiority or Other||Geometric Mean Ratio|1.02|Standard Deviation|21.33|||2-Sided|90.0|0.93|1.12|||||The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg : Olodaterol 10 µg). No formal testing.|
1625116|NCT02231177|2984498|Superiority or Other||Geometric Mean Ratio|0.96|Standard Deviation|29.92|||2-Sided|90.0|0.87|1.07|||||The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg : Tiotropium 5 µg). No formal testing.|
1625117|NCT02231177|2984499|Superiority or Other||Geometric Mean Ratio|0.9|Standard Deviation|19.81|||2-Sided|90.0|0.83|0.98|||||The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg: Tiotropium 5 µg). No formal testing.|
1625119|NCT02231177|2984501|Superiority or Other||Geometric Mean Ratio|0.98|Standard Deviation|20.43|||2-Sided|90.0|0.91|1.06|||||The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Tiotropium (Tiotropium+Olodaterol 5/10 μg: Tiotropium 5 µg). No formal testing.|
1625120|NCT02231177|2984502|Superiority or Other||Geometric Mean Ratio|1.11|Standard Deviation|27.17|||2-Sided|90.0|1.01|1.22|||||The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.|
1625121|NCT02231177|2984503|Superiority or Other||Geometric Mean Ratio|1.12|Standard Deviation|32.15|||2-Sided|90.0|0.99|1.27|||||The standard deviation is actually the geometric intra-individual coefficient of variation.|Comparison of Olodaterol (Tiotropium+Olodaterol 5/10 μg: Olodaterol 10 µg). No formal testing.|
1625122|NCT02230995|2984505|Superiority or Other||Adjusted gMean ratio|104.66|Standard Deviation|7.3|||2-Sided|90.0|101.36|108.07|||||Relative bioavailability of metformin was estimated by the ratios of the adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).||
1625123|NCT02230995|2984506|Superiority or Other||Adjusted gMean ratio|98.32|Standard Deviation|5.1|||2-Sided|90.0|96.16|100.53|||||Relative bioavailability of empagliflozin was estimated by ratios of adjusted geometric means (gMean) of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).||
1625124|NCT02230995|2984507|Non-Inferiority or Equivalence|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|105.69|Standard Deviation|10.9|<|1e-05|2-Sided|90.0|100.78|110.84|||ANOVA|ANOVA model on the logarithmic scale including random effects for ‘subjects within sequences’ & fixed effect for ‘sequence’, ‘period’ & ‘treatment’.|Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).||
1625125|NCT02230995|2984508|Non-Inferiority or Equivalence|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|98.7|Standard Deviation|12.3|<|1e-05|2-Sided|90.0|93.51|104.17|||ANOVA|ANOVA model on the logarithmic scale including random effects for ‘subjects within sequences’ & fixed effect for ‘sequence’, ‘period’ & ‘treatment’.|Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).||
1625126|NCT02230995|2984509|Non-Inferiority or Equivalence|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|102.14|Standard Deviation|7.9|<|1e-05|2-Sided|90.0|98.65|105.76|||ANOVA|ANOVA model on the logarithmic scale including random effects for ‘subjects within sequences’ & fixed effect for ‘sequence’, ‘period’ & ‘treatment’.|Relative bioavailability of metformin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).||
1625127|NCT02230995|2984510|Non-Inferiority or Equivalence|The assessment of bioequivalence was based on 2-sided 90% confidence intervals (CIs) for the ratios (test to reference treatment) of the adjusted geometric means (gMeans) of the primary endpoints, using an acceptance range of 80.00 to 125.00%.|Adjusted gMean ratio|98.22|Standard Deviation|5.0|<|1e-05|2-Sided|90.0|96.11|100.39|||ANOVA|ANOVA model on the logarithmic scale including random effects for ‘subjects within sequences’ & fixed effect for ‘sequence’, ‘period’ & ‘treatment’.|Relative bioavailability of empagliflozin was estimated by the ratios of the adjusted gMean of Fed 25mg+1000mg FDC divided by Fed 25mg+1000mg Single. Standard deviation is actually Intra individual geometric coefficient variation (gCV).||
1625128|NCT02230904|2984516|Superiority or Other||Mean Difference (Final Values)|0.442|Standard Deviation|0.895|||2-Sided|||||||||The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.|
1625129|NCT02230904|2984523|Superiority or Other||Mean Difference (Final Values)|1.115|Standard Deviation|1.635|||2-Sided|||||||||The change in average adhesiveness score was average score for Treatment B minus average score for Treatment A.|
1625130|NCT02230761|2984524|Superiority or Other|||||||0.002|||||||t-test, 2 sided||||
1625131|NCT02230761|2984525|Superiority or Other|||||||0.001|||||||t-test, 2 sided||||
1625132|NCT02230761|2984526|Superiority or Other|||||||0.02|||||||Chi-squared||||
1625133|NCT02230683|2984527|Superiority or Other||Hodges-Lehmann|-772.0||||0.003|2-Sided|95.0|-1188.0|-19.0|||Wilcoxon (Mann-Whitney)||The estimated value is the ratio for the difference from baseline.|Statistical Analysis for the median change in concentration of Caspase 3/7 Relative Light Units from baseline to Day 28/EOT|
1625134|NCT02230683|2984528|Superiority or Other||Hodges-Lehmann|-4.0||||0.0131|2-Sided|95.0|-7.0|-1.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change in Aspartate Aminotransferase (AST) from Baseline to Day 28/EOT|
1625135|NCT02230683|2984529|Superiority or Other||Hodges-Lehmann|-4.0||||0.0084|2-Sided|95.0|-7.0|0.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change in Alanine Aminotransferase (ALT) from Baseline to Day 28/EOT|
1625136|NCT02230683|2984530|Superiority or Other||Hodges-Lehmann|12.0||||0.839|2-Sided|95.0|-60.0|13.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily|
1625137|NCT02230683|2984530|Superiority or Other||Hodges-Lehmann|-52.5||||0.016|2-Sided|95.0|-109.0|-6.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG < 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily|
1625138|NCT02230683|2984530|Superiority or Other||Hodges-Lehmann|-21.0||||0.105|2-Sided|95.0|-60.0|13.0|||Wilcoxon (Mann-Whitney)|||Statistical Analysis for the median change of caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily|
1625139|NCT02230683|2984531|Superiority or Other||within group change|-0.04||||0.72|2-Sided|95.0|-0.26|0.18|||ANCOVA|||Statistical Analysis for the median change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily|
1625140|NCT02230683|2984531|Superiority or Other||within group change|-0.46||||0.001|2-Sided|95.0|-0.72|-0.21|||ANCOVA|||Statistical Analysis for the mean change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT in the HVPG < 12 mmHg subgroup population treated with IDN-6556 25 mg twice daily|
1625141|NCT02230683|2984531|Superiority or Other||within group change|-0.22||||0.026|2-Sided|95.0|-0.42|-0.03|||ANCOVA|||Statistical Analysis for the mean change in log-transformed caspase-cleaved cytokeratin serum levels from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily|
1625142|NCT02230683|2984532|Superiority or Other||within group change|-3.67|Standard Deviation|4.05||0.0025|2-Sided|95.0|-5.88|-1.46|||ANCOVA||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT in the HVPG ≥ 12 mmHg subgroup|
1625143|NCT02230683|2984532|Superiority or Other||within group change|1.9|Standard Deviation|3.15||0.1174|2-Sided|95.0|-0.52|4.32|||ANCOVA||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT in the HVPG < 12 mmHg subgroup|
1625144|NCT02230683|2984532|Superiority or Other||within group change|-1.14|Standard Deviation|4.57||0.257|2-Sided|95.0|-3.16|0.89|||Paired t-test||within group change|Statistical Analysis for the mean change of the Hepatic Venous Pressure Gradient from Baseline to Day 28/EOT for the overall evaluable population treated with IDN-6556 25 mg twice daily|
1625145|NCT02230670|2984533|Superiority||Median Difference (Final Values)|-1.6|Standard Error of the Mean|1.46||0.029|2-Sided|95.0|-3.09|-0.17|||ANCOVA|calculated from the estimated least square means for the treatment by etiology interaction term.||NASH Etiology subgroup results (N=20), as analyzed from the adjusted analysis ANCOVA model adjusting for baseline value, baseline MELD score, and etiology.|
1625146|NCT02230670|2984533|Superiority||Median Difference (Final Values)|-2.19|Standard Error of the Mean|1.42||0.003|2-Sided|95.0|-3.61|-0.77|||ANCOVA|calculated from the estimated least square means for the treatment by BL MELD category interaction term.||BL MELD >= 15 subgroup results (N=19), as analyzed from the adjusted analysis ANCOVA model adjusting for baseline value, baseline MELD score, and etiology.|
1625147|NCT02230670|2984533|Superiority||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.333||0.466|2-Sided|95.0|-0.91|0.42|||ANCOVA|||Analysis was conducted using an ANCOVA model adjusting for baseline value.|
1625148|NCT02230670|2984534|Superiority||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.21||0.041|2-Sided|95.0|-0.41|0.01|||ANCOVA|||The analysis was conducted using an ANCOVA model adjusting for baseline value, baseline MELD score, and etiology. The significance was assessed using Type II Sums of Squares from this ANCOVA model.|
1625149|NCT02230670|2984534|Superiority||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.0817||0.091|2-Sided|95.0|-0.302|0.023|||ANCOVA|||Analysis was conducted using an ANCOVA model adjusting for baseline value.|
1625150|NCT02230566|2984540|Superiority||LS Mean|-1.2||||0.2022|2-Sided|95.0|-3.0|0.6|||GEE||||
1625151|NCT02230566|2984542|Superiority||LS Mean|3.4||||0.1953|2-Sided|95.0|-1.8|8.6|||GEE||||
1625152|NCT02230566|2984543|Superiority||LS Mean|0.2||||0.102|2-Sided|95.0|0.0|0.4|||GEE|||Scale-RUNNING SPEED AND AGILITY|
1625153|NCT02230566|2984543|Superiority||LS Mean|0.2||||0.4094|2-Sided|95.0|-0.2|0.6|||GEE|||Scale-MANUAL DEXTERITY|
1625154|NCT02230566|2984543|Superiority||LS Mean|-0.2||||0.3528|2-Sided|95.0|-0.7|0.2|||GEE|||Scale: FINE MOTOR PRECISION|
1625155|NCT02230566|2984543|Superiority||LS Mean|0.8||||0.0883|2-Sided|95.0|-0.1|1.7|||GEE|||Scale-BALANCE|
1625156|NCT02230566|2984544|Superiority||LS Mean|0.9||||0.0906|2-Sided|95.0|-0.1|1.8|||GEE|||for the right eye|
1625157|NCT02230566|2984544|Superiority||LS Mean|1.0||||0.114|2-Sided|95.0|-0.2|2.2|||GEE|||for the left eye|
1625158|NCT02230566|2984545|Superiority||LS Mean|-6.7||||0.0563|2-Sided|95.0|-13.6|0.2|||GEE|||Tighter Shoulder Extension|
1625159|NCT02230566|2984545|Superiority||LS Mean|-9.4||||0.0415|2-Sided|95.0|-18.4|-0.4|||GEE|||Tighter Shoulder Flexion|
1625160|NCT02230566|2984545|Superiority||LS Mean|-3.4||||0.3332|2-Sided|95.0|-10.2|3.4|||GEE|||Shoulder Extension - Right|
1625161|NCT02230566|2984545|Superiority||LS Mean|-1.8||||0.6034|2-Sided|95.0|-8.8|5.1|||GEE|||Shoulder Flexion - Right|
1625162|NCT02230566|2984545|Superiority||LS Mean|-1.5||||0.7632|2-Sided|95.0|-10.9|8.0|||GEE|||Shoulder Extension - Left|
1625163|NCT02230566|2984545|Superiority||LS Mean|-6.5||||0.1778|2-Sided|95.0|-16.1|3.0|||GEE|||Shoulder Flexion - Left|
1625164|NCT02230566|2984548|Superiority||LS Mean|20.8||||0.2137|2-Sided|95.0|-12.0|53.7||P-values are from GEE model including baseline value, and the post UX003 Treatment Week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|GEE||||
1625165|NCT02230566|2984549|Superiority|||||||0.0527|||||||t-test|"P value from t-test of no change (0 change) from baseline"|||
1625166|NCT02230566|2984550|Superiority||LS Mean|-64.82|||<|0.0001|2-Sided|95.0|-69.66|-59.98||P-values are from GEE model including baseline value, and the post UX003 Treatment Week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|GEE||||
1625167|NCT02229539|2984631|Superiority or Other (legacy)|||||||0.004|||||||Wilcoxon rank-sum||||
1625168|NCT02229539|2984631|Superiority or Other (legacy)|||||||0.01|||||||Wilcoxon rank-sum||||
1625169|NCT02229487|2984647|Other|||||||0.209|||||||Wilcoxon (Mann-Whitney)||||
1625170|NCT02229396|2984663|Superiority or Other||Mean Difference (Final Values)|-2.4|Standard Error of the Mean|1.06||0.022|2-Sided|95.0|-4.5|-0.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.|||
1625171|NCT02229396|2984663|Superiority or Other||Mean Difference (Final Values)|-3.0|Standard Error of the Mean|1.08||0.005|2-Sided|95.0|-5.2|-0.9|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.|||
1625173|NCT02229396|2984664|Superiority or Other||Difference in percentages|17.9|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (<9.0% or ≥9.0%).|||
1625174|NCT02229396|2984665|Superiority or Other||Mean Difference (Final Values)|-15.03|Standard Error of the Mean|3.477|<|0.001|2-Sided|95.0|-21.85|-8.2||This is a nominal p-value.|Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.|||
1625175|NCT02229396|2984665|Superiority or Other||Mean Difference (Final Values)|-20.26|Standard Error of the Mean|3.494|<|0.001|2-Sided|95.0|-27.12|-13.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.|||
1625176|NCT02229396|2984666|Superiority or Other||Difference in percentages|13.3||||0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (<9.0% or ≥9.0%).|||
1625177|NCT02229396|2984666|Superiority or Other||Difference in percentages|19.7|||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (<9.0% or ≥9.0%).|||
1625178|NCT02229396|2984667|Superiority or Other||Mean Difference (Final Values)|-26.78|Standard Error of the Mean|5.09|<|0.001|2-Sided|95.0|-36.78|-16.78|||ANCOVA|Treatment, region, and baseline HbA1c stratum (<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.|||
1625179|NCT02229396|2984667|Superiority or Other||Mean Difference (Final Values)|-27.74|Standard Error of the Mean|5.168|<|0.001|2-Sided|95.0|-37.89|-17.59|||ANCOVA|Treatment, region, and baseline HbA1c stratum (<9.0% or ≥9.0%), as fixed factors; baseline value as covariate.|||
1625180|NCT02229396|2984668|Superiority or Other||Mean Difference (Final Values)|-16.64|Standard Error of the Mean|3.947|<|0.001|2-Sided|95.0|-24.39|-8.89|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.|||
1625181|NCT02229396|2984668|Superiority or Other||Mean Difference (Final Values)|-20.08|Standard Error of the Mean|4.007|<|0.001|2-Sided|95.0|-27.95|-12.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.|||
1625182|NCT02229396|2984669|Superiority or Other||Mean Difference (Final Values)|-1.33|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-2.12|-0.55|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.|||
1625183|NCT02229396|2984669|Superiority or Other||Mean Difference (Final Values)|-2.0|Standard Error of the Mean|0.406|<|0.001|2-Sided|95.0|-2.79|-1.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.|||
1625184|NCT02229396|2984670|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|0.127|<|0.001|2-Sided|95.0|-0.84|-0.34|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.|||
1625185|NCT02229396|2984670|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.129|<|0.003|2-Sided|95.0|-0.63|-0.13|||Mixed Models Analysis|Treatment, region, baseline HbA1c stratum (<9.0% or ≥9.0%), week, and treatment by week interaction as fixed factors; baseline value as covariate.|||
1625186|NCT02229383|2984671|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|1.13||0.11|2-Sided|95.0|-4.0|0.4|||Mixed Models Analysis|Treatment, region, baseline HbA1c (< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.|||
1625187|NCT02229383|2984672|Superiority or Other||Difference in percentages|20.0|||<|0.001|2-Sided||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (<9.0% or ≥9.0%) and baseline SU-use (yes vs. no).|||
1625188|NCT02229383|2984673|Superiority or Other||Mean Difference (Final Values)|-1.9|Standard Error of the Mean|1.08||0.074|2-Sided|95.0|-4.1|0.2|||Mixed Models Analysis|Treatment, region, baseline HbA1c (< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.|||
1625189|NCT02229383|2984674|Superiority or Other||Difference in percentages|25.6|||<|0.001|2-Sided||||||Cochran-Mantel-Haenszel|Stratified by baseline HbA1c (<9.0% or ≥9.0%) and baseline SU-use (yes vs. no).|||
1625190|NCT02229383|2984675|Superiority or Other||Mean Difference (Final Values)|-27.76|Standard Error of the Mean|5.754|<|0.001|2-Sided|95.0|-39.07|-16.45|||ANCOVA|Treatment, region, baseline HbA1c (< or ≥ 9.0%), baseline SU-use (yes vs. no) as fixed factors; baseline value as covariate.|||
1625191|NCT02229383|2984676|Superiority or Other||Mean Difference (Final Values)|-1.52|Standard Error of the Mean|0.341|<|0.001|2-Sided|95.0|-2.19|-0.85|||Mixed Models Analysis|Treatment, region, baseline HbA1c (< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.|||
1625192|NCT02229383|2984677|Superiority or Other||Mean Difference (Final Values)|-0.74|Standard Error of the Mean|0.101|<|0.001|2-Sided|95.0|-0.94|-0.54|||Mixed Models Analysis|Treatment, region, baseline HbA1c (< or ≥ 9.0%), baseline SU-use, week, treatment by week interaction as fixed factors; baseline value as covariate.|||
1625193|NCT02229227|2984698|Other||Odds Ratio (OR)|3.78|||<|0.0001|2-Sided|95.0|2.21|6.48||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.||
1625194|NCT02229227|2984699|Other||Odds Ratio (OR)|2.36|||<|0.0001|2-Sided|95.0|1.54|3.6||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.||
1625195|NCT02229227|2984700|Other||Odds Ratio (OR)|3.5|||<|0.0001|2-Sided|95.0|2.52|4.86||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.||
1625196|NCT02229227|2984702|Superiority||Mean Difference (Final Values)|-61.83|||<|0.0001|2-Sided|95.0|-65.85|-57.81|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|week 26|
1625197|NCT02229227|2984702|Other||Mean Difference (Final Values)|-62.92|||<||2-Sided|95.0|-66.69|-59.15|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18|
1625198|NCT02229227|2984702|Other||Mean Difference (Final Values)|-64.76|||<||2-Sided|95.0|-67.68|-61.85|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10|
1625199|NCT02229227|2984702|Other||Mean Difference (Final Values)|-56.05|||<||2-Sided|95.0|-58.17|-53.94|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4|
1625200|NCT02229227|2984703|Other||Mean Difference (Final Values)|0.39||||0.7699|2-Sided|95.0|-2.25|3.04|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26|
1625201|NCT02229227|2984703|Other||Mean Difference (Final Values)|0.24|||||2-Sided|95.0|-2.21|2.69|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18|
1625202|NCT02229227|2984703|Other||Mean Difference (Final Values)|0.34|||||2-Sided|95.0|-1.64|2.33|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10|
1625203|NCT02229227|2984703|Superiority||Mean Difference (Final Values)|-0.97|||||2-Sided|95.0|-2.25|0.3|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4|
1625204|NCT02229227|2984704|Other||Mean Difference (Final Values)|-62.0|||||2-Sided|95.0|-67.29|-56.7|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18|
1625205|NCT02229227|2984704|Other||Mean Difference (Final Values)|-63.7|||||2-Sided|95.0|-67.78|-59.62|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10|
1625206|NCT02229227|2984704|Other||Mean Difference (Final Values)|-56.38|||||2-Sided|95.0|-59.19|-53.57|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4|
1625207|NCT02229227|2984706|Other||Odds Ratio (OR)|1.08||||0.8292|2-Sided|95.0|0.24|4.77||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.||
1625208|NCT02229227|2984707|Other||Odds Ratio (OR)|0.85||||0.2298|2-Sided|95.0|0.63|1.17||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26|
1625209|NCT02229227|2984707|Other||Odds Ratio (OR)|0.81||||0.079|2-Sided|95.0|0.59|1.11||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18|
1625210|NCT02229227|2984707|Other||Odds Ratio (OR)|0.81||||0.2139|2-Sided|95.0|0.58|1.14||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10|
1625211|NCT02229227|2984707|Other||Odds Ratio (OR)|1.24||||0.4703|2-Sided|95.0|0.8|1.91||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5|
1625212|NCT02229227|2984707|Other||Odds Ratio (OR)|1.32||||0.2143|2-Sided|95.0|0.78|2.23||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4|
1625213|NCT02229227|2984708|Other||Odds Ratio (OR)|0.85||||0.2298|2-Sided|95.0|0.63|1.17||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.||
1625214|NCT02229227|2984709|Other||Odds Ratio (OR)|0.96||||0.7026|2-Sided|95.0|0.71|1.31||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26|
1625215|NCT02229227|2984709|Other||Odds Ratio (OR)|0.75||||0.0518|2-Sided|95.0|0.54|1.03||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18|
1625216|NCT02229227|2984709|Other||Odds Ratio (OR)|0.71||||0.0151|2-Sided|95.0|0.52|0.98||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10|
1625217|NCT02229227|2984709|Other||Odds Ratio (OR)|0.82||||0.3034|2-Sided|95.0|0.59|1.15||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5|
1625275|NCT02227784|2984843|Superiority or Other (legacy)||Median Difference (Final Values)|48.44|||<|0.001|2-Sided|95.0|43.82|52.86|||ANCOVA||||
1625218|NCT02229227|2984709|Other||Odds Ratio (OR)|1.17||||0.2883|2-Sided|95.0|0.84|1.64||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for baseline HbA1c category, age category, region and current use of metformin|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4|Week 4|
1625219|NCT02229227|2984710|Other||Odds Ratio (OR)|0.96||||0.7026|2-Sided|95.0|0.71|1.31||Non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.||
1625220|NCT02229227|2984711|Superiority||Mean Difference (Net)|-0.55||||0.0004|2-Sided|95.0|-0.86|-0.25|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26|
1625221|NCT02229227|2984711|Other||Mean Difference (Net)|-0.53|||||2-Sided|95.0|-0.85|-0.22|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18|
1625222|NCT02229227|2984711|Other||Mean Difference (Net)|-0.19|||||2-Sided|95.0|-0.51|0.13|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5|
1625223|NCT02229227|2984711|Other||Mean Difference (Net)|-0.54|||||2-Sided|95.0|-0.84|-0.24|||||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4|
1625224|NCT02229227|2984712|Superiority||Mean Difference (Net)|-0.55||||0.0004|2-Sided|95.0|-0.86|-0.25|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.||
1625225|NCT02229227|2984713|Non-Inferiority|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.06|||<|0.0001|2-Sided|95.0|-0.05|0.17|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 26.|Week 26|
1625226|NCT02229227|2984713|Non-Inferiority|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.11|||<|0.0001|2-Sided|95.0|0.01|0.21|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 18.|Week 18|
1625227|NCT02229227|2984713|Non-Inferiority|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|0.08|||<|0.0001|2-Sided|95.0|-0.01|0.17|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 10.|Week 10|
1625228|NCT02229227|2984713|Non-Inferiority|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|-0.09|||<|0.0001|2-Sided|95.0|-0.15|-0.02|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 5.|Week 5|
1625229|NCT02229227|2984713|Non-Inferiority|Difference in change from Baseline least squares means (albiglutide - insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance|Mean Difference (Net)|-0.12|||<|0.0001|2-Sided|95.0|-0.18|-0.07|||t-test, 1 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented for Week 4.|Week 4|
1625230|NCT02229227|2984714|Superiority||Mean Difference (Final Values)|-60.83|||<|0.0001|2-Sided|95.0|-66.57|-55.1|||t-test, 2 sided||Least square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.||
1625231|NCT02229227|2984715|Other||Mean Difference (Net)|-4.37|||<|0.0001|2-Sided|95.0|-4.93|-3.82|||t-test, 2 sided||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 26 has been presented.|Week 26|
1625232|NCT02229227|2984715|Other||Mean Difference (Net)|-4.01|||<||2-Sided|95.0|-4.48|-3.54|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 18 has been presented.|Week 18|
1625233|NCT02229227|2984715|Other||Mean Difference (Net)|-3.17|||<||2-Sided|95.0|-3.51|-2.82|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 10 has been presented.|Week 10|
1625234|NCT02229227|2984715|Other||Mean Difference (Net)|-1.8|||<||2-Sided|95.0|-2.05|-1.55|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 5 has been presented.|Week 5|
1625235|NCT02229227|2984715|Other||Mean Difference (Net)|-1.21|||<||2-Sided|95.0|-1.43|-1.0|||||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) at Week 4 has been presented.|Week 4|
1625236|NCT02229227|2984716|Superiority||Mean Difference (Net)|-4.37|||<|0.0001|2-Sided|95.0|-4.93|-3.82|||t-test, 2 sided||Least Square mean difference (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.||
1625237|NCT02229227|2984717|Other||Odds Ratio (OR)|0.43|||<|0.0001|2-Sided|95.0|0.31|0.6||Analysis was performed using non-parametric Cochran-Mantel-Haenszel (CMH) test after adjusting for Baseline HbA1c category, age category, region and current use of metformin.|Cochran-Mantel-Haenszel||Odds ratio (albiglutide + insulin glargine minus insulin lispro + insulin glargine) has been presented.||
1625238|NCT02229227|2984719|Non-Inferiority|If the upper bound of the confidence interval is less than or equal to 0.3%, non-inferiority will be concluded.|Mean Difference (Net)|0.06|||<|0.0001|2-Sided|95.0|-0.05|0.17||Non-inferiority p-value. P-value from testing the null hypothesis that the difference in change from baseline least squares means (albiglutide-insulin lispro) is greater than 0.30% based on one-sided t-test with 0.025 level of significance.|t-test, 2 sided||Least Square mean of albiglutide + insulin glargine from insulin lispro + insulin glargine has been presented.||
1625239|NCT02228967|2984732|Other||Mean Difference (Net)|-0.015||||0.897|2-Sided|||||A priori alpha set at 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.|
1625240|NCT02228967|2984733|Other||Mean Difference (Net)|3.163|Standard Error of the Mean|1.44||0.029|2-Sided|||||A priori alpha set at 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.|
1625241|NCT02228967|2984734|Other||Mean Difference (Net)|0.393|Standard Error of the Mean|0.362||0.278|2-Sided|||||A priori alpha set at 0.05|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.|
1625242|NCT02228967|2984735|Other||Mean Difference (Final Values)|0.345|Standard Error of the Mean|0.203||0.091|2-Sided|||||A priori threshold for statistical significance was 0.05.|Repeated Measures GLM|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.|
1625243|NCT02228967|2984736|Other||||||=|0||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparison tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare means differences at follow-up.|
1625244|NCT02228967|2984737|Other||||||<|0.001||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.|
1625245|NCT02228967|2984738|Other||||||=|0||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.|
1625246|NCT02228967|2984739|Other||||||=|0||||||A priori threshold for statistical significance was 0.05.|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tets (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.|
1625247|NCT02228967|2984740|Other||||||=|0|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.|
1625248|NCT02228967|2984741|Other||||||=|0|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.|
1625249|NCT02228967|2984742|Other||||||=|0|||||||Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.|
1625250|NCT02228967|2984743|Other||||||=|0||||||A priori threshold for statistical significance was 0.05|Repeated Measures--General Linear Model|||Data were analyzed using a GLM repeated measures approach. A priori means comparisons tests (usual care vs. SBIRT intervention) with Bonferroni corrections were used to compare mean differences at follow-up.|
1625251|NCT02228824|2984744|Superiority||Mean Difference (Final Values)|-0.02||||0.03|2-Sided|95.0|-0.04|-0.002|||Mixed Models Analysis||||
1625252|NCT02228824|2984745|Superiority||Mean Difference (Final Values)|-0.7||||0.016|2-Sided|95.0|-1.26|-0.13|||ANCOVA|ANCOVA was performed on 25 sets of imputed data and then analyzed using SAS PROC MIANALYZE|||
1625253|NCT02228824|2984746|Superiority||Mean Difference (Final Values)|-38.5||||0.041|2-Sided|95.0|-75.21|-1.78|||Mixed Models Analysis||||
1625254|NCT02228824|2984748|Superiority||Mean Difference (Final Values)|1.51|||<|0.001|2-Sided|95.0|0.86|2.17|||ANCOVA|ANCOVA was performed on 25 sets of imputed data and then analyzed using SAS PROC MIANALYZE|||
1625255|NCT02228460|2984780|Other|||||||0.625||||||Threshold for significance at 0.05 level.|Wilcoxon signed rank test|||Wilcoxon signed rank test was used to assess the mean change from Baseline to Week 26 in skin GL-3 score.|
1625256|NCT02228460|2984781|Other|||||||0.3173||||||Threshold for significance at 0.05 level.|McNemar Test|||A McNemar test was used to test the treatment effect based on paired pre-treatment and post-treatment (Week 26) frequencies of skin GL-3 score grouped into the categories (0 to <2; 2 to 3).|
1625257|NCT02227810|2984835|Superiority or Other|||||||0.792|||||||t-test, 2 sided||||
1625258|NCT02227810|2984836|Superiority or Other|||||||0.051|||||||t-test, 2 sided||||
1625259|NCT02227810|2984837|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1625260|NCT02227810|2984837|Superiority||||||<|0.051|||||||t-test, 2 sided||||
1625261|NCT02227810|2984838|Superiority|||||||0.123|||||||t-test, 2 sided||||
1625262|NCT02227810|2984838|Other|||||||0.652|||||||t-test, 2 sided||||
1625263|NCT02227784|2984839|Superiority or Other (legacy)||Median Difference (Final Values)|-42.15|||<|0.001|2-Sided|95.0|-50.9|-33.4|||ANCOVA||||
1625264|NCT02227784|2984839|Superiority or Other (legacy)||Median Difference (Final Values)|-32.63|||<|0.001|2-Sided|95.0|-44.0|-21.8|||ANCOVA||||
1625265|NCT02227784|2984839|Superiority or Other (legacy)||Median Difference (Final Values)|-33.18|||<|0.001|2-Sided|95.0|-44.9|-22.3|||ANCOVA||||
1625266|NCT02227784|2984840|Superiority or Other (legacy)||Median Difference (Final Values)|39.64|||<|0.001|2-Sided|95.0|33.2|46.08|||ANCOVA||||
1625267|NCT02227784|2984840|Superiority or Other (legacy)||Median Difference (Final Values)|42.12|||<|0.001|2-Sided|95.0|34.29|49.76|||ANCOVA||||
1625268|NCT02227784|2984840|Superiority or Other (legacy)||Median Difference (Final Values)|38.05|||<|0.001|2-Sided|95.0|30.17|45.88|||ANCOVA||||
1625269|NCT02227784|2984841|Superiority or Other (legacy)||Median Difference (Final Values)|-4.11||||0.062|2-Sided|95.0|-8.47|0.15|||ANCOVA||||
1625270|NCT02227784|2984841|Superiority or Other (legacy)||Median Difference (Final Values)|-16.42|||<|0.001|2-Sided|95.0|-22.3|-10.6|||ANCOVA||||
1625271|NCT02227784|2984841|Superiority or Other (legacy)||Median Difference (Final Values)|-23.16|||<|0.001|2-Sided|95.0|-30.0|-16.5|||ANCOVA||||
1625451|NCT02223364|2985266|Superiority|||||||0.043|||||||Wilcoxon (Mann-Whitney)||||
1625278|NCT02227784|2984844|Superiority or Other (legacy)||Median Difference (Final Values)|127.57|||<|0.001|2-Sided|95.0|120.1|135.0|||Mixed Models Analysis||||
1625279|NCT02227784|2984844|Superiority or Other (legacy)||Median Difference (Final Values)|131.48|||<|0.001|2-Sided|95.0|123.5|139.5|||Mixed Models Analysis||||
1625280|NCT02227784|2984844|Superiority or Other (legacy)||Median Difference (Final Values)|125.28|||<|0.001|2-Sided|95.0|117.1|133.6|||Mixed Models Analysis||||
1625281|NCT02227784|2984845|Superiority or Other (legacy)||Median Difference (Final Values)|-6.14||||0.045|2-Sided|95.0|-12.2|-0.22|||ANCOVA||||
1625282|NCT02227784|2984845|Superiority or Other (legacy)||Median Difference (Final Values)|-27.24|||<|0.001|2-Sided|95.0|-36.6|-18.5|||ANCOVA||||
1625283|NCT02227784|2984845|Superiority or Other (legacy)||Median Difference (Final Values)|-33.48|||<|0.001|2-Sided|95.0|-44.4|-23.3|||ANCOVA||||
1625284|NCT02227693|2984860|Other|||||||0.901||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)|
1625285|NCT02227693|2984860|Other|||||||0.216||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)|
1625286|NCT02227693|2984860|Other|||||||0.154||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 6 (Day 35)|
1625287|NCT02227693|2984860|Other|||||||0.01||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)|
1625288|NCT02227693|2984860|Other|||||||0.009||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)|
1625289|NCT02227693|2984860|Other|||||||0.624||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 5 (Day 17)|
1625290|NCT02227693|2984860|Other|||||||0.001||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)|
1625291|NCT02227693|2984860|Other|||||||0.001||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)|
1625292|NCT02227693|2984860|Other|||||||0.012||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 4 (Day 10)|
1625293|NCT02227693|2984860|Other|||||||0.138||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)|
1625294|NCT02227693|2984860|Other|||||||0.07||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)|
1625295|NCT02227693|2984860|Other|||||||0.296||||||P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.|Wilcoxon (Mann-Whitney)|||Visit 3 (Day 4 or Day 5)|
1625296|NCT02227693|2984863|Other||Difference of proportion vs. placebo|10.0||||0.476|2-Sided|95.0|-8.6|28.6||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)|
1625297|NCT02227693|2984863|Other||Difference of proportion vs. placebo|30.0||||0.09|2-Sided|95.0|1.6|58.4||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)|
1625298|NCT02227693|2984863|Other||Difference of proportion vs. placebo|63.6||||0.003|2-Sided|95.0|35.2|92.1||P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)|
1625299|NCT02227693|2984864|Other||Difference of proportion vs. placebo|-18.2||||0.476|2-Sided|95.0|-41.0|4.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)|
1625300|NCT02227693|2984864|Other||Difference of proportion vs. placebo|-9.1||||1|2-Sided|95.0|-37.5|19.3||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)|
1625301|NCT02227693|2984864|Other||Difference of proportion vs. placebo|-18.2||||0.496|2-Sided|95.0|-41.0|4.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 6 (Day 35)|
1625302|NCT02227693|2984864|Other||Difference of proportion vs. placebo|-7.3||||1|2-Sided|95.0|-43.4|28.9||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)|
1625303|NCT02227693|2984864|Other||Difference of proportion vs. placebo|27.3||||0.386|2-Sided|95.0|-12.2|66.8||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)|
1625326|NCT02227147|2984913|Superiority||difference in percentage|0.5|||=|0|2-Sided|95.0|-18.5|19.6|||Chi-squared|||week 6|
1625304|NCT02227693|2984864|Other||Difference of proportion vs. placebo|-27.3||||0.245|2-Sided|95.0|-53.6|-1.0||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 5 (Day 17)|
1625305|NCT02227693|2984864|Other||Difference of proportion vs. placebo|40.9||||0.063|2-Sided|95.0|5.6|76.2||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)|
1625306|NCT02227693|2984864|Other||Difference of proportion vs. placebo|72.7||||0.001|2-Sided|95.0|44.3|100.0||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)|
1625307|NCT02227693|2984864|Other||Difference of proportion vs. placebo|62.3||||0.012|2-Sided|95.0|24.8|99.9||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 4 (Day 10)|
1625308|NCT02227693|2984864|Other||Difference of proportion vs. placebo|27.3||||0.214|2-Sided|95.0|1.0|53.6||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 3 (Day 4 or Day 5)|
1625309|NCT02227693|2984864|Other||Difference of proportion vs. placebo|14.3||||0.388|2-Sided|95.0|-11.6|40.2||P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.|Fisher Exact||Difference of proportion vs. placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|Visit 3 (Day 4 or Day 5)|
1625310|NCT02227693|2984865|Other||Difference of responder rate vs. placebo|30.9||||0.024|2-Sided|95.0|-3.9|65.7|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag – responder rate for placebo; 95% CI is calculated based on normal approximation.||
1625311|NCT02227693|2984865|Other||Difference of responder rate vs. placebo|54.5||||0.004|2-Sided|95.0|21.4|87.7|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag – responder rate for placebo; 95% CI is calculated based on normal approximation.||
1625312|NCT02227693|2984865|Other||Difference of responder rate vs. placebo|19.5||||0.146|2-Sided|95.0|-18.1|57.0|||Shirley-Williams test|P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.|Difference of responder rate vs. placebo = responder rate for avatrombopag – responder rate for placebo; 95% CI is calculated based on normal approximation.||
1625313|NCT02227368|2984872|Superiority or Other||Mean Difference (Net)|0.1||||0.6186|2-Sided|95.0|-0.4|0.6|||t-test, 2 sided||Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.||
1625314|NCT02227368|2984873|Superiority or Other||Mean Difference (Net)|-0.1||||0.3441|2-Sided|95.0|-0.4|0.1|||t-test, 2 sided||Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.||
1625315|NCT02227329|2984874|Superiority|||||||0.17|||||||t-test, 2 sided||||
1625316|NCT02227238|2984886|Other||Mean Difference (Net)|-0.358||||0.0004|2-Sided|95.0|-0.555|-0.161|||Multiple imputation||Estimates at Week 48 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.||
1625317|NCT02227238|2984886|Other||Mean Difference (Net)|-0.542|||<|0.0001|2-Sided|95.0|-0.729|-0.356|||Multiple imputation||Estimates at Week 24 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.||
1625318|NCT02227238|2984887|Other||Mean Difference (Net)|-0.147||||0.01|2-Sided|95.0|-0.259|-0.035|||'Multiple imputation||Mean difference at Week 48 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age||
1625319|NCT02227238|2984887|Other||Mean Difference (Net)|-0.171||||0.001|2-Sided|95.0|-0.272|-0.069|||Multiple imputation||Mean difference at Week 24 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age||
1625320|NCT02227238|2984907|Other||Proportion difference|9.8|||||2-Sided|95.0|5.3|14.4|||||Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 48 has been presented.||
1625321|NCT02227238|2984907|Other||Proportion difference|5.7|||||2-Sided|95.0|2.2|9.3|||||Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 24 has been presented.||
1625322|NCT02227238|2984910|Superiority|Non-inferiority of DTG plus 2 NRTI's was to be declared if the lower bound of 95% confidence interval (CI) for the difference in snapshot response rates (DTG – LPV/RTV) is greater than - 12%. This was also performed using the Per-Protocol (PP) Population. If both analyses show non-inferiority, the hypothesis of antiviral effect of DTG + 2 NRTI's was superior to LPV/RTV + 2 NRTIs was to be tested.|Proportion difference|13.8|||<|0.001|2-Sided|95.0|7.3|20.3|||Cochran-Mantel-Haenszel||Adjusted proportion difference, calculated as proportion on DTG minus that on LPV/RTV and based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline plasma HIV-1 RNA and number of fully active background NRTIs, has been presented.||Superiority would be declared if the lower end of the confidence interval was above 0%
1625323|NCT02227147|2984911|Superiority||difference in percentage|-13.3|||=|0|2-Sided|95.0|-30.5|3.9|||Chi-squared||||
1625324|NCT02227147|2984912|Superiority||least square mean difference|0.6|||=|0|2-Sided|95.0|-0.4|1.5|||ANCOVA||||
1625325|NCT02227147|2984913|Superiority||difference in percentage|-3.6|||=|0|2-Sided|95.0|-23.9|16.7|||Chi-squared|||week 8|
1625327|NCT02227147|2984913|Superiority||difference in percentage|-3.8|||=|0|2-Sided|95.0|-21.3|13.7|||Chi-squared|||week 4|
1625328|NCT02227147|2984914|Superiority||difference in least square means|1.1|||=|0|2-Sided|95.0|-5.6|7.7|||ANCOVA||||
1625329|NCT02227147|2984915|Superiority||difference in percentage|18.6|||=|0|2-Sided|95.0|-0.7|37.8|||Chi-squared|||week 8|
1625330|NCT02227147|2984915|Superiority||difference in percentage|0.8|||=|0|2-Sided|95.0|-15.6|17.1|||Chi-squared|||week 6|
1625331|NCT02227147|2984915|Superiority||difference in percentage|9.5|||=|0|2-Sided|95.0|-6.9|25.9|||Chi-squared|||week 4|
1625332|NCT02227147|2984916|Superiority||difference in percentage|23.6|||=|0|2-Sided|95.0|-4.2|51.3|||Chi-squared|||week 6 - investigator|
1625333|NCT02227147|2984916|Superiority||difference in percentage|14.9|||=|0|2-Sided|95.0|-13.4|43.1|||Chi-squared|||week 4 - investigator|
1625334|NCT02227147|2984916|Superiority||difference in percentage|10.7|||=|0|2-Sided|95.0|-17.7|39.1|||Chi-squared|||week 6 - central reviewer|
1625335|NCT02227147|2984916|Superiority||difference in percentage|19.0|||=|0|2-Sided|95.0|-9.0|47.1|||Chi-squared|||week 4 - central reviewer|
1625336|NCT02227147|2984917|Superiority||Difference in percentage|36.1|||=|0|2-Sided|95.0|9.4|62.7|||Chi-squared||||
1625337|NCT02227147|2984918|Superiority||Difference in percentage|40.4|||=|0|2-Sided|90.0|14.2|66.6|||Chi-squared||||
1625338|NCT02227121|2984919|Superiority or Other||Percentage|92.86|||||1-Sided|95.0|70.3|||||||Null Hypothesis: Percentage of Subjects with Successful VF Termination ≤ 65% Alternative Hypothesis: Percentage of Subjects with Successful VF Termination > 65%|
1625339|NCT02226562|2984961|Superiority or Other||Mean Difference (Net)|-1.1||||0.0001|2-Sided|95.0|-1.28|-0.92||The P-value was less than 0.0001|ANCOVA|ANCOVA with a factor for treatment and baseline as covariate|||
1625340|NCT02226198|2984969|Superiority or Other||Relative difference in geometric LSM|-20.4||||0.013|2-Sided|95.0|-32.8|-5.6||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625341|NCT02226198|2984970|Superiority or Other||Relative difference in geometric LSM|-28.2||||0.005|2-Sided|95.0|-41.7|-11.4||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625342|NCT02226198|2984971|Superiority or Other||Relative difference in geometric LSM|-25.6||||0.005|2-Sided|95.0|-38.1|-10.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625343|NCT02226198|2984972|Superiority or Other||Relative difference in geometric LSM|-27.6||||0.006|2-Sided|95.0|-41.2|-11.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625344|NCT02226198|2984973|Superiority or Other||Relative difference in geometric LSM|-30.4||||0.004|2-Sided|95.0|-44.2|-13.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625345|NCT02226198|2984974|Superiority or Other||Relative difference in geometric LSM|-30.4||||0.004|2-Sided|95.0|-44.2|-13.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625346|NCT02226198|2984985|Superiority or Other||Relative difference in geometric LSM|-26.3||||0.08|2-Sided|95.0|-48.7|6.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625347|NCT02226198|2984986|Superiority or Other||Relative difference in geometric LSM|-26.3||||0.08|2-Sided|95.0|-48.7|6.0||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625348|NCT02226198|2984987|Superiority or Other||Relative difference in geometric LSM|7.4||||0.314|2-Sided|95.0|-7.4|24.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625349|NCT02226198|2984988|Superiority or Other||Relative difference in geometric LSM|7.4||||0.314|2-Sided|95.0|-7.4|24.5||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625350|NCT02226198|2984989|Superiority or Other||Relative difference in geometric LSM|-17.1||||0.024|2-Sided|95.0|-29.2|-2.9||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625351|NCT02226198|2984990|Superiority or Other||Relative difference in geometric LSM|-17.1||||0.024|2-Sided|95.0|-29.2|-2.9||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625352|NCT02226198|2984991|Superiority or Other||Relative difference in geometric LSM|-22.9||||0.003|2-Sided|95.0|-33.7|-10.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625353|NCT02226198|2984992|Superiority or Other||Relative difference in geometric LSM|-22.9||||0.003|2-Sided|95.0|-33.7|-10.3||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625354|NCT02226198|2984993|Superiority or Other||Relative difference in geometric LSM|-20.1||||0.003|2-Sided|95.0|-29.7|-9.1||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625355|NCT02226198|2984994|Superiority or Other||Relative difference in geometric LSM|-20.1||||0.003|2-Sided|95.0|-29.7|-9.1||statistical significance set at 0.05|Mixed Models Analysis|||cross-over, null hypothesis is no difference between ros and plc.|
1625356|NCT02226198|2984995|Superiority or Other||Relative difference in geometric LSM|-22.3||||0.005|2-Sided|95.0|-33.5|-9.1||statistical significance set at 0.05|Mixed Models Analysis||Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.|cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta|
1625357|NCT02226198|2984996|Superiority or Other||Relative difference in geometric LSM|-22.3||||0.005|2-Sided|95.0|-33.5|-9.1||statistical significance set at 0.05|Mixed Models Analysis||Rosuvastatin treatment gives on average a 22.3% lower geometric LS mean than placebo.|cross-over, null hypothesis is no difference between ros and plc. Powered for 90% detection of 15% delta|
1625438|NCT02223364|2985262|Superiority|||||||0.104|||||||Wilcoxon (Mann-Whitney)||||
1625358|NCT02226003|2985026|Superiority or Other||Difference in the Least Squares Means|-2.18||||0.08|2-Sided|95.0|-4.62|0.26|||Constrained Longitudinal Data Analysis||||
1625359|NCT02226003|2985026|Superiority or Other||Difference in the Least Squares Means|-1.65||||0.184|2-Sided|95.0|-4.09|0.79|||Constrained Longitudinal Data Analysis||||
1625360|NCT02226003|2985027|Superiority or Other||Difference in the Least Squares Means|-6.39|||<|0.001|2-Sided|95.0|-9.83|-2.95|||Constrained Longitudinal Data Analysis||||
1625361|NCT02226003|2985027|Superiority or Other||Difference in the Least Squares Means|-4.44|||<|0.011|2-Sided|95.0|-7.87|-1.01|||Constrained Longitudinal Data Analysis||||
1625362|NCT02226003|2985028|Superiority or Other||Difference in the Least Squares Means|-2.1|||<|0.001|2-Sided|95.0|-3.1|-1.11|||Constrained Longitudinal Data Analysis||||
1625363|NCT02226003|2985028|Superiority or Other||Difference in the Least Squares Means|-2.0|||<|0.001|2-Sided|95.0|-2.99|-1.01|||Constrained Longitudinal Data Analysis||||
1625364|NCT02226003|2985029|Superiority or Other||Odds Ratio (OR)|7.39|||<|0.001|2-Sided|95.0|2.98|18.31|||Logistic regression model||||
1625365|NCT02226003|2985029|Superiority or Other||Odds Ratio (OR)|6.88|||<|0.001|2-Sided|95.0|2.81|16.83|||Logistic regression model||||
1625366|NCT02226003|2985030|Superiority or Other||Difference in the Least Squares Means|-69.65|||<|0.001|2-Sided|95.0|-87.83|-51.46|||Constrained Longitudinal Data Analysis||||
1625367|NCT02226003|2985030|Superiority or Other||Difference in the Least Squares Means|-62.42|||<|0.001|2-Sided|95.0|-80.47|-44.37|||Constrained Longitudinal Data Analysis||||
1625368|NCT02226003|2985031|Superiority or Other||Difference in the Least Squares Means|-46.05|||<|0.001|2-Sided|95.0|-57.09|-35.02|||Constrained Longitudinal Data Analysis||||
1625369|NCT02226003|2985031|Superiority or Other||Difference in the Least Squares Means|-38.94|||<|0.001|2-Sided|95.0|-49.93|-27.96|||Constrained Longitudinal Data Analysis||||
1625370|NCT02226003|2985033|Superiority or Other||Difference in Percentage vs Placebo|2.5|||||2-Sided|95.0|-11.4|16.4|||||||
1625371|NCT02226003|2985033|Superiority or Other||Difference in Percentage vs Placebo|2.6|||||2-Sided|95.0|-11.2|16.4|||||||
1625372|NCT02226003|2985034|Superiority or Other||Difference in the Least Squares Means|-1.24|||<|0.001|2-Sided|95.0|-1.57|-0.91|||Constrained Longitudinal Data Analysis||||
1625373|NCT02226003|2985034|Superiority or Other||Difference in the Least Squares Means|-1.16|||<|0.001|2-Sided|95.0|-1.49|-0.84|||Constrained Longitudinal Data Analysis||||
1625374|NCT02225860|2985044|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|||The analysis of the primary and secondary outcome was based on an intention to treat principle. Copeptin was measured in each subject at baseline and week 2 and the change from baseline to end point (“delta”) was calculated for all subjects. The delta copeptin between subjects in the intervention and control arms was compared with a two sample t test for independent groups. One sample t-tests of the delta were used to examine whether there was any change over time for each group separately.|
1625375|NCT02225860|2985045|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|||"The analysis of the primary and secondary outcome was based on an intention to treat principle. Copeptin was measured in each subject at baseline and week 2 and the change from baseline to end point (delta) was calculated for all subjects. The delta copeptin between subjects in the intervention and control arms was compared with a two sample t test for independent groups. One sample t-tests of the delta were used to examine whether there was any change over time for each group separately."|
1625376|NCT02224755|2985091|Superiority||Risk Ratio (RR)|0.21|||<|0.001|2-Sided|95.0|0.11|0.38|||Fisher Exact|||Based on data in the Sponsor’s device tracking database, 7% of patients with the HeartMate II LVAS receive a pump replacement by 24 months. The expected proportion of patients with the HeartMate 3 LVAS to receive a pump replacement by 24 months was assumed to be 3%. We estimated that to demonstrate superiority of HeartMate 3 to HeartMate II with a power of 80% and α = 0.05 (2-sided), a total of 1028 patients (514 per arm) were required using the Fisher’s exact test.|
1625377|NCT02224755|2985092|Non-Inferiority|Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.|Risk Difference (RD)|19.2|||<|0.001|1-Sided|95.0|9.8||||Farrington-Manning risk difference||||
1625378|NCT02224755|2985093|Non-Inferiority|Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.|Risk Difference (RD)|9.4|||<|0.001|1-Sided|95.0|-2.1||||Farrington-Manning risk difference||||
1625379|NCT02224703|2985099|Superiority||Odds Ratio (OR)|2.93||||0.0009|2-Sided|95.0|1.56|5.53|||Regression, Logistic||Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.||
1625380|NCT02224703|2985099|Superiority||Odds Ratio (OR)|2.02||||0.0279|2-Sided|95.0|1.08|3.78|||Regression, Logistic||Proportional odds modelling was carried out by including treatment group as a fixed factor. The estimated OR tested the null hypothesis that OR was equal to 1.||
1625381|NCT02224703|2985100|Superiority||Odds Ratio (OR)|2.21||||0.0332|2-Sided|95.0|1.06|4.62|||Cochran-Mantel-Haenszel|P-value calculated from a Cochran–Mantel–Haenszel test stratified by age group (2–5, 6–12, and 13–18 years).|||
1625382|NCT02224703|2985100|Superiority||Odds Ratio (OR)|2.74||||0.0069|2-Sided|95.0|1.32|5.7|||Cochran-Mantel-Haenszel|P-value calculated from a Cochran–Mantel–Haenszel test stratified by age group (2–5, 6–12, and 13–18 years).|||
1625383|NCT02224703|2985101|Superiority||Treatment Ratio|0.62||||0.0003|2-Sided|95.0|0.481|0.799|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.|
1625439|NCT02223364|2985262|Superiority|||||||0.171|||||||Wilcoxon (Mann-Whitney)||||
1625440|NCT02223364|2985262|Superiority|||||||0.807|||||||Wilcoxon (Mann-Whitney)||||
1625441|NCT02223364|2985263|Superiority|||||||0.496|||||||Wilcoxon (Mann-Whitney)||||
1625384|NCT02224703|2985101|Superiority||Treatment Ratio|0.749||||0.0255|2-Sided|95.0|0.581|0.965|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset.|
1625385|NCT02224703|2985102|Superiority||Treatment Ratio|0.702||||0.0095|2-Sided|95.0|0.538|0.916|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.|
1625386|NCT02224703|2985102|Superiority||Treatment Ratio|0.743||||0.0299|2-Sided|95.0|0.568|0.971|||Negative binomial regression|||Model includes total number of seizures as a response variable and age group, time (baseline and treatment period), treatment, and treatment by time interaction as fixed effects, and participant as a random effect. Log-transformed number of days in which seizures were reported by period is included as an offset. Null hypothesis was that the ratio of GWP42003-P to placebo would be 1.|
1625387|NCT02224690|2985103|Superiority||Odds Ratio (OR)|2.54||||0.0012|2-Sided|95.0|1.45|4.47|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor.|Odds of participants recording a lower score (improvement) on a continuous scale||
1625388|NCT02224690|2985104|Superiority||Mean Difference (Final Values)|-21.13||||0.0005|2-Sided|95.0|-33.26|-9.37|||Wilcoxon rank-sum test||Calculated using the Hodges–Lehmann approach||
1625389|NCT02224690|2985105|Superiority||Odds Ratio (OR)|2.57||||0.0043|2-Sided|95.0|1.33|4.97|||Cochran-Mantel-Haenszel|Calculated using a Cochran-Mantel-Haenszel test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)|||
1625390|NCT02224690|2985106|Superiority||Median Difference (Final Values)|-17.21||||0.0135|2-Sided|95.0|-30.32|-4.09|||Wilcoxon rank-sum test||Calculated using the Hodges–Lehmann approach||
1625391|NCT02224560|2985138|Superiority||Odds Ratio (OR)|2.57||||0.002|2-Sided|95.0|1.41|4.66|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor|Odds of participant recording a lower score (improvement) on a continuous scale||
1625392|NCT02224560|2985138|Superiority||Odds Ratio (OR)|1.83||||0.0439|2-Sided|95.0|1.02|3.3|||Regression, Logistic|Ordinal logistic regression model with treatment group as a fixed factor|Odds of participant recording a lower score (improvement) on a continuous scale||
1625393|NCT02224560|2985139|Superiority||Median Difference (Final Values)|-19.47||||0.0015|2-Sided|95.0|-30.37|-7.47|||Wilcoxon rank-sum test||Calculated using the Hodges–Lehmann approach||
1625394|NCT02224560|2985139|Superiority||Median Difference (Final Values)|-18.76||||0.0091|2-Sided|95.0|-31.8|-4.43|||Wilcoxon rank-sum test||Calculated using the Hodges–Lehmann approach||
1625395|NCT02224560|2985140|Superiority||Odds Ratio (OR)|3.27||||0.003|2-Sided|95.0|1.47|7.26||Calculated using a CMH test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)|Cochran-Mantel-Haenszel||||
1625396|NCT02224560|2985140|Superiority||Odds Ratio (OR)|3.85||||0.0006|2-Sided|95.0|1.75|8.47||Calculated using a Cochran–Mantel–Haenszel (CMH) test stratified by age group (2-5, 6-11, 12-17 and 18-55 years)|Cochran-Mantel-Haenszel||||
1625397|NCT02224560|2985141|Superiority||Median Difference (Final Values)|-19.19||||0.0016|2-Sided|95.0|-31.24|-7.69|||Wilcoxon rank-sum test||Calculated using the Hodges–Lehmann approach||
1625398|NCT02224560|2985141|Superiority||Median Difference (Final Values)|-21.57||||0.0047|2-Sided|95.0|-34.79|-6.67|||Wilcoxon rank-sum test||Calculated using the Hodges–Lehmann approach||
1625399|NCT02224157|2985152|Superiority||Rate ratio|0.97||||0.754|2-Sided|95.0|0.78|1.2|||Negative binomial model|Adjusted for randomised treatment, pre-study treatment and region. Logarithm of follow-up time is used as an offset variable.|A rate ratio less than 1 indicates a lower rate of exacerbations in the Symbicort 'as needed' treatment group.||
1625400|NCT02224157|2985153|Superiority||Least Square Mean Difference|-0.096|||<|0.001|2-Sided|95.0|-0.137|-0.054|||Mixed Models Analysis|rand treatment, pre-study treatment, region, visit, rand treat by visit as fixed, patient as random and baseline AQLQ as covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.||
1625401|NCT02224157|2985154|Superiority||Least Square Mean Difference|0.109|||<|0.001|2-Sided|95.0|0.068|0.15|||Mixed Models Analysis|rand treatment, pre-study treatment, region, visit, rand treat by visit as fixed, patient as random, and baseline ACQ-5 as covariate.|Mean difference less than 0 favours Symbicort 'as needed'.||
1625402|NCT02224157|2985155|Superiority||Least Square Mean Difference|-37.48|||<|0.001|2-Sided|95.0|-39.18|-35.77|||ANOVA|model adjusted for: randomised treatment, pre-study treatment and region.|An estimate of difference >0 means that there was a higher % of controller use days in the Symbicort 'as-needed' group.||
1625403|NCT02224157|2985156|Superiority||Least Square Mean Difference|-6.85|||<|0.001|2-Sided|95.0|-8.37|-5.34|||ANCOVA|adjusted for randomised treatment, pre-study treatment and region as factors and the percent 'as needed' free days during run-in as a cont covariate.|An estimate of difference >0 means that there was a larger increase in the % of 'as needed' free days in the Symbicort 'as-needed' arm.||
1625404|NCT02224157|2985157|Superiority||Least Square Mean Difference|0.03|||||2-Sided|95.0|0.0|0.07|||||A mean difference less than zero indicates a larger mean reduction in number of 'as needed' inhalations in the Symbicort 'as needed' group.||
1625405|NCT02224157|2985159|Superiority||Least Square Mean Difference|-32.6||||0.003|2-Sided|95.0|-53.7|-11.4|||Mixed Models Analysis|Rand treatment,pre-study treatment,region,visit,rand treatment by visit; fixed effects. Patient; random effect, baseline FEV1; covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. Estimate corresponds to average treatment effect across all treatment visits.||
1625406|NCT02224157|2985160|Superiority||Hazard Ratio (HR)|0.955||||0.664|2-Sided|95.0|0.777|1.174|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.||
1625442|NCT02223364|2985263|Superiority|||||||0.991|||||||Wilcoxon (Mann-Whitney)||||
1625443|NCT02223364|2985263|Superiority|||||||0.571|||||||Wilcoxon (Mann-Whitney)||||
1625444|NCT02223364|2985264|Superiority|||||||0.797|||||||Wilcoxon (Mann-Whitney)||||
1625407|NCT02224157|2985161|Non-Inferiority|Non-inferiority analysis based on CI instead of p-value, hence no p-value calculated for this analysis. Upper limit of the 1-sided 95% confidence limit <1.2 indicates Symbicort 'as needed' is non-inferior to Pulmicort bid|Rate ratio|0.97|||||1-Sided|95.0||1.16|||||A rate ratio less than 1 indicates a lower rate of exacerbations in the Symbicort 'as needed' treatment group.||
1625408|NCT02224053|2985164|Non-Inferiority or Equivalence|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|94.03|||||2-Sided|90.0|89.92|98.33||||||AZ7550|
1625409|NCT02224053|2985164|Non-Inferiority or Equivalence|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|102.32|||||2-Sided|90.0|96.87|108.07|||||AZD9291+omeprazole / AZD9291 alone|AZ5104|
1625410|NCT02224053|2985165|Non-Inferiority or Equivalence|90% CIs of geometric mean ratios being within 80% to 125%|Geomteric mean ratio|89.7|||||2-Sided|90.0|83.89|95.91||||||AZ7550|
1625411|NCT02224053|2985165|Non-Inferiority or Equivalence|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|94.79|||||2-Sided|90.0|88.77|101.21||||||AZ5104|
1625412|NCT02224053|2985174|Non-Inferiority or Equivalence|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|101.65|||||2-Sided|90.0|94.65|109.16|||||AZD9291+omeprazole / AZD9291 alone|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 80% to 125% was 90% (95% for each parameter). Within subject CV assumed to be 23%. 5% change in exposure also assumed.|
1625413|NCT02224053|2985175|Non-Inferiority or Equivalence|90% CIs of geometric mean ratios being within 80% to 125%|Geometric mean ratio|106.66|||||2-Sided|90.0|100.26|113.46|||||AZD9291+omeprazole / AZD9291 alone|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 80% to 125% was 90% (95% for each parameter). Within subject CV assumed to be 23%. 5% change in exposure also assumed.|
1625414|NCT02223858|2985185|Superiority|A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscale, and a 80% power.||||||0.901|||||||Mixed Models Analysis|All models adjusted for site.|||
1625415|NCT02223858|2985186|Superiority|A sample size of 360 (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.||||||0.88|||||||Mixed Models Analysis|All models adjusted for site.|||
1625416|NCT02223858|2985187|Superiority|A sample size of 360 patients (180 non-Hispanic white and 180 non-Hispanic African American) was chosen based on a priori power calculations to detect a 3-way interaction between treatment group, race, and time, assuming a 20% change in baseline, the WOMAC pain subscales, and a 80% power.||||||0.791|||||||Mixed Models Analysis|All models adjusted for site.|||
1625417|NCT02223702|2985203|Superiority or Other||||||<|0.01|||||||ANOVA|All rows were compared to eachother|||
1625418|NCT02223702|2985204|Superiority or Other||||||<|0.01|||||||Friedman Test|All rows were compared to eachother|||
1625419|NCT02223650|2985207|Superiority or Other||Risk Difference (RD)|0.001||||0.54|2-Sided|95.0|-23.0|24.0||The p-value was not adjusted for multiple comparisons.|Chi-squared||||
1625420|NCT02223650|2985215|Superiority or Other||Risk Difference (RD)|21.0||||0.07|2-Sided|95.0|-6.0|45.0||The p-value was not adjusted for multiple comparisons.|Chi-squared||||
1625421|NCT02223650|2985218|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.14|2-Sided|95.0|-0.68|0.19||P-value is calculated for one-sided hypothesis test.|ANCOVA|Comparison of mean 8-wk near control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.|Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.||
1625422|NCT02223650|2985219|Superiority or Other||Mean Difference (Final Values)|-0.75||||0.01|2-Sided|95.0|-1.42|-0.07||P-value is calculated for one-sided hypothesis test.|ANCOVA|Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline distance control pre-study spectacle wear, and pre-study IXT treatment|Difference in mean distance control (overminus – observation) and 95% CI from ANCOVA model adjusting for baseline control, pre-study spectacle wear, and pre-study treatment for IXT. + difference suggests observation group worse than overminus group||
1625423|NCT02223390|2985254|Superiority|A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot RCT with two conditions.||||||0.05||||||A priori threshold was defined as p<0.05.|Chi-squared||||
1625424|NCT02223390|2985255|Superiority|A sample size of 60 was chosen as adequate to examine the feasibility and acceptability of a pilot randomized controlled trial (RCT) with two conditions.||||||0.08||||||A priori threshold for statistical significance was p<.05. The p-value presented corresponds to the time by condition interaction parameter.|Mixed Models Analysis|To assess changes in PTSD symptoms over time by intervention condition, linear mixed models were fit using the PROC MIXED procedure in SAS.||Statistical analyses reported below is for PCL - Total at 3 months.|
1625425|NCT02223364|2985256|Superiority|||||||0.048|||||||Regression, Cox|||Within group comparison of baseline and three months (approximately 12 weeks)|
1625426|NCT02223364|2985256|Superiority|||||||0.001|||||||Regression, Cox|||Within group comparison of baseline and 3 months (approximately 12 weeks)|
1625427|NCT02223364|2985256|Superiority|||||||0.623|||||||Regression, Cox|||Within group comparison of baseline and 3 months (approximately 12 weeks)|
1625428|NCT02223364|2985257|Superiority|||||||0.768|||||||Kruskal-Wallis||||
1625429|NCT02223364|2985258|Superiority|||||||0.126|||||||Wilcoxon (Mann-Whitney)||||
1625430|NCT02223364|2985258|Superiority|||||||0.169|||||||Wilcoxon (Mann-Whitney)||||
1625431|NCT02223364|2985258|Superiority|||||||0.933|||||||Wilcoxon (Mann-Whitney)||||
1625432|NCT02223364|2985259|Superiority|||||||0.148|||||||Wilcoxon (Mann-Whitney)||||
1625433|NCT02223364|2985259|Superiority|||||||0.007|||||||Wilcoxon (Mann-Whitney)||||
1625434|NCT02223364|2985259|Superiority|||||||0.202|||||||Wilcoxon (Mann-Whitney)||||
1625435|NCT02223364|2985260|Superiority|||||||0.293|||||||Wilcoxon (Mann-Whitney)||||
1625436|NCT02223364|2985260|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1625437|NCT02223364|2985260|Superiority||||||<|0.012|||||||Wilcoxon (Mann-Whitney)||||
1625452|NCT02223364|2985266|Superiority|||||||0.189|||||||Wilcoxon (Mann-Whitney)||||
1625453|NCT02223364|2985267|Superiority|||||||0.214|||||||Wilcoxon (Mann-Whitney)||||
1625454|NCT02223364|2985267|Superiority|||||||0.005|||||||Wilcoxon (Mann-Whitney)||||
1625455|NCT02223364|2985267|Superiority|||||||0.059|||||||Wilcoxon (Mann-Whitney)||||
1625456|NCT02223364|2985268|Superiority|||||||0.257|||||||Wilcoxon (Mann-Whitney)||||
1625457|NCT02223364|2985268|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1625458|NCT02223364|2985268|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1625459|NCT02223364|2985269|Superiority|||||||0.021|||||||Wilcoxon (Mann-Whitney)||||
1625460|NCT02223364|2985269|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1625461|NCT02223364|2985269|Superiority||||||<|0.003|||||||Wilcoxon (Mann-Whitney)||||
1625462|NCT02223364|2985270|Superiority|||||||0.196|||||||Wilcoxon (Mann-Whitney)||||
1625463|NCT02223364|2985270|Superiority|||||||0.016|||||||Wilcoxon (Mann-Whitney)||||
1625464|NCT02223364|2985270|Superiority|||||||0.144|||||||Wilcoxon (Mann-Whitney)||||
1625465|NCT02223065|2985299|Non-Inferiority or Equivalence|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.013||||0.3191|2-Sided|90.0|0.992|1.034|||ANOVA||||
1625466|NCT02223065|2985300|Non-Inferiority or Equivalence|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.024||||0.1947|2-Sided|90.0|0.993|1.056|||ANOVA||||
1625467|NCT02223065|2985301|Non-Inferiority or Equivalence|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.016||||0.2458|2-Sided|90.0|0.993|1.038|||ANOVA||||
1625468|NCT02223065|2985302|Non-Inferiority or Equivalence|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|1.022||||0.2344|2-Sided|90.0|0.991|1.054|||ANOVA||||
1625469|NCT02223065|2985303|Non-Inferiority or Equivalence|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|0.993||||0.865|2-Sided|90.0|0.932|1.06|||ANOVA||||
1625470|NCT02223065|2985304|Non-Inferiority or Equivalence|The specified bioequivalence limits (0.80, 1.25) for PK measures|Geometric mean ratio|0.975||||0.495|2-Sided|90.0|0.915|1.038|||ANOVA||||
1625471|NCT02222818|2985310|Superiority or Other||Mean Difference (Net)|7.0|Standard Deviation|8.7|<|0.0001|2-Sided|95.86|4.5|9.5||The threshold for statistical significance was 0.0207, determined by the pre-specified alpha spending function accounting for one interim analysis.|t-test, 1 sided|||Null Hypothesis (Ho): μd ≤ 0% Alternative Hypothesis (Ha): μd > 0% where μd is the paired difference in percent effective CRT pacing during AF between when CAFRPlus is applied and when CAFR is applied, based on subjects’ paired measurements from the two cross-over follow-up periods.|
1625472|NCT02222818|2985311|Non-Inferiority or Equivalence|In order to demonstrate that CAFRPlus is no less effective than CAFR by a non-inferiority margin of 2%, assuming a true paired difference of 6% and a standard deviation of 15% for the paired differences, a sample size of 39 subjects with paired data is required to achieve 90% statistical power using the one-sample t-test for non-inferiority, while controlling the one-sided type I error rate at 0.025.|Mean Difference (Net)|7.0|Standard Deviation|8.7|<|0.0001|2-Sided|95.86|4.5|9.5||The threshold for statistical significance was 0.0207, determined by the pre-specified alpha spending function accounting for one interim analysis.|t-test, 1 sided|||Null Hypothesis (Ho): μd ≤ -2% Alternative Hypothesis (Ha): μd > -2% where μd is the paired difference in percent effective CRT pacing during AF between when CAFRPlus is applied and when CAFR is applied, based on subjects’ paired measurements from the two cross-over follow-up periods, and -2% is the non-inferiority margin selected based upon clinical judgment.|
1625473|NCT02222493|2985360|Non-Inferiority or Equivalence|Equivalence test|Proportion Difference|-2.39|||||2-Sided|90.0|-8.75|4.02||||||Score statistic method|
1625474|NCT02222493|2985360|Non-Inferiority or Equivalence|Equivalence test|Proportion Difference|-2.39|||||2-Sided|95.0|-9.92|5.11||||||Score statistic method|
1625475|NCT02222246|2985371|Non-Inferiority|Incidence of the need for supplemental oxygen during Emergency Department visit||||||0.0726|||||||Chi-squared||||
1625476|NCT02222246|2985372|Non-Inferiority|Incidence of sedation during Emergency Department visit.||||||0.3915|||||||Chi-squared||||
1625477|NCT02222246|2985374|Non-Inferiority|Incidence of oxygen desaturation (<95%) YES during Emergency Department visit||||||0.2891|||||||Chi-squared||||
1625478|NCT02222246|2985375|Non-Inferiority|Decrease in diastolic blood pressure (>= 20% baseline)||||||0.5372|||||||Chi-squared||||
1625479|NCT02222246|2985376|Non-Inferiority|Decrease in systolic BP (>= 20% of baseline)||||||0.4473|||||||Chi-squared||||
1625480|NCT02222246|2985377|Non-Inferiority|Incidence of vomiting (YES) during Emergency Department visit||||||0.6625|||||||Chi-squared||||
1625481|NCT02222246|2985378|Non-Inferiority|Incidence of nausea during Emergency Department Visit - YES||||||0.0001|||||||Chi-squared||||
1625482|NCT02222246|2985379|Non-Inferiority|Emergency Department Discharge||||||0.0007|||||||t-test, 2 sided||||
1625483|NCT02222246|2985379|Non-Inferiority|Post-placement 120 minutes||||||0.2457|||||||t-test, 2 sided||||
1625484|NCT02222246|2985379|Non-Inferiority|Post-placement 90 minutes||||||0.3678|||||||t-test, 2 sided||||
1625485|NCT02222246|2985379|Non-Inferiority|Post-placement 60 minutes||||||0.53|||||||t-test, 2 sided||||
1625486|NCT02222246|2985379|Non-Inferiority|Post-placement 30 minutes||||||0.7259|||||||t-test, 2 sided||||
1625487|NCT02222246|2985379|Non-Inferiority|Emergency Department Arrival||||||0.9393|||||||t-test, 2 sided||||
1625488|NCT02222246|2985379|Non-Inferiority|Trajectory of pain across time (arrival to discharge)||||||0.0049||||||p-value for the protocol by time interaction|Mixed Models Analysis|||The trajectory of change in pain score was evaluated every 30 minutes over 120 hours (2 hours) rather than 6 hours because of expected missing data after 120 minutes due to discharge from the ED.|
1625489|NCT02222246|2985380|Non-Inferiority|Change in pain scores from arrival to discharge||||||0.0311|||||||Mixed Models Analysis|Analysis for pain change was conducted using Hierarchical Linear Mixed Effects Model (HLM), adjusting for nested patient and site effects (N=126)|||
1625490|NCT02222181|2985385|Superiority or Other|||||||0.05|||||||t-test, 1 sided||||
1625491|NCT02222181|2985386|Superiority or Other||||||<|0.001|||||||t-test, 1 sided||||
1625492|NCT02222181|2985387|Superiority or Other|||||||0.025|||||||t-test, 1 sided||||
1625493|NCT02222181|2985388|Superiority or Other||||||<|0.001|||||||t-test, 1 sided||||
1625494|NCT02222181|2985389|Superiority or Other|||||||0.03|||||||t-test, 1 sided||||
1625495|NCT02222181|2985390|Superiority or Other|||||||0.05|||||||t-test, 1 sided||||
1625496|NCT02222181|2985391|Superiority or Other|||||||0.23|||||||t-test, 1 sided||||
1625497|NCT02222129|2985395|Superiority or Other|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed using SAS, version 9.2 (Statistical Analysis Software, Cary, NC). All power calculations were at the 80% level with an alpha of 0.05. Based upon opioid consumption data previously reported for robotic-assisted laparoscopic prostatectomy, a sample size of 74 would be necessary to detect a 10 mg difference in morphine equivalents totaled over the entire hospital stay. (Webster TM, Herrell SD, Chang SS, et al. The Journal of Urology 2005;174(3):912-914.|
1625498|NCT02221947|2985396|Other||mean (h*ng/mL)|1.05|||||2-Sided||||||||SD=0.330|Bryostatin plasma concentration AUC0-last (h*ng/mL)|
1625499|NCT02221947|2985396|Other||mean Tmax(h)|0.92|||||2-Sided||||||||SD=0.206|Bryostatin plasma concentration: mean Tmax (h)|
1625500|NCT02221648|2985420|Superiority or Other|||||||0.0448|||||||Fisher Exact||||
1625501|NCT02221648|2985421|Superiority or Other|||||||0.0293|||||||Fisher Exact||||
1625502|NCT02221648|2985422|Superiority or Other|||||||0.447|||||||Fisher Exact||||
1625503|NCT02220998|2985458|Superiority or Other|||||||0.018||||||P-value was stratified by cirrhosis status and prior treatment experience.|Cochran-Mantel-Haenszel|||The superiority of SOF/VEL for 12 weeks over SOF+RBV for 12 weeks was to be tested if the efficacy of SOF/VEL for 12 weeks was demonstrated to be statistically noninferior to SOF+RBV for 12 weeks (ie, if the lower bound of the 95% CI for the strata-adjusted difference in the proportions between groups was greater than the prespecified noninferiority margin of −10%).|
1625504|NCT02220998|2985458|Non-Inferiority or Equivalence|A sample size of 120 per treatment group provided 90% power to establish non-inferiority in the SVR12 rates between the SOF/VEL group and the SOF+RBV group. It was based on the assumptions that the non-inferiority margin is 10%, both groups have a SVR12 rate of 94%, and the significance level is 0.025 one-sided.|Difference in proportions|5.2|||||2-Sided|95.0|0.2|10.3|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.||
1625505|NCT02220920|2985460|Superiority or Other||Least-Squares Mean Difference|-1.24|Standard Error of the Mean|1.03||0.232|2-Sided|95.0|-3.27|0.8|||ANCOVA||Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in diastolic blood pressure for week 16.||
1625506|NCT02220920|2985460|Superiority or Other||Least-Squares Mean Difference|-3.19|Standard Error of the Mean|1.67||0.058|2-Sided|95.0|-6.49|0.11|||ANCOVA||Estimated P-Value, Least-Squares Mean Difference, Standard Error of the mean, 95% CI are presented for the change from Baseline in systolic blood pressure for week 16.||
1625507|NCT02220920|2985461|Superiority or Other||Least-Squares Mean Difference|-2.37|Standard Error of the Mean|0.36|<|0.001|2-Sided|95.0|-3.09|-1.65|||ANCOVA||||
1625508|NCT02220920|2985462|Superiority or Other||Least-Squares Mean Difference|-32.6|Standard Error of the Mean|6.9|<|0.001|2-Sided|95.0|-46.3|-18.9|||ANCOVA||||
1625509|NCT02220920|2985463|Superiority or Other||Least-Squares Mean Difference|-1.1|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|-1.33|-0.87|||ANCOVA||||
1625510|NCT02220894|2985470|Superiority||Difference in Percentage (DP)|0.7||||0.3798|2-Sided|95.0|-4.0|5.5||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages >0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen & Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).||
1625511|NCT02220894|2985471|Superiority||Difference in Percentage (DP)|4.9||||0.0638|2-Sided|95.0|-1.4|11.1||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages >0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen & Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).||
1625512|NCT02220894|2985472|Superiority||Difference in Percentage (DP)|7.4||||0.0289|2-Sided|95.0|-0.2|15.0||One-sided p-value for testing. H0: difference in percentages=0 vs. H1: difference in percentages >0|Stratified Miettinen and Nurminen||DP for pembrolizumab vs. chemotherapy based on Miettinen & Nurminen method stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous).||
1625513|NCT02220894|2985473|Superiority||Hazard Ratio (HR)|1.07||||0.8445|2-Sided|95.0|0.94|1.21||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).||
1625514|NCT02220894|2985474|Superiority||Hazard Ratio (HR)|0.94||||0.2331|2-Sided|95.0|0.8|1.11||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).||
1625515|NCT02220894|2985475|Superiority||Hazard Ratio (HR)|0.82||||0.0187|2-Sided|95.0|0.68|0.99||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. non-squamous).||
1625516|NCT02220894|2985476|Superiority||Hazard Ratio (HR)|0.81||||0.0018|2-Sided|95.0|0.71|0.93||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).||
1625546|NCT02219685|2985524|Superiority or Other|||||||0.96||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided||||
1626691|NCT02194933|2987774|Superiority or Other|||||||0.0578|||||||Mixed Models Analysis||||
1625517|NCT02220894|2985477|Superiority||Hazard Ratio (HR)|0.77||||0.002|2-Sided|95.0|0.64|0.92||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), PD-L1 expression status (TPS=≥50% vs. TPS=1-49%) and histology (squamous vs. non-squamous).||
1625518|NCT02220894|2985478|Superiority||Hazard Ratio (HR)|0.69||||0.0003|2-Sided|95.0|0.56|0.85||One-sided p-value based on stratified log-rank test|Log Rank||Hazard ratio based on Cox regression model with treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1), and histology (squamous vs. non-squamous).||
1625519|NCT02220764|2985485|Superiority or Other|||||||0.03|||||||Log Rank|||Null hypothesis: The chipping rates between tooth- and implant- supoorted FDPs are equally distributed.|
1625520|NCT02220725|2985488|Superiority||Hodges-Lehman estimate of shift|1205.05|||<|0.0001|2-Sided|95.0|1034.17|1400.79|||2-sided test exact Wilcoxon rank-sum tes||||
1625521|NCT02220725|2985488|Superiority||Hodges-Lehman estimate of shift|1142.66|||<|0.0001|2-Sided|95.0|1006.1|1281.4|||2-sided test exact Wilcoxon rank-sum tes||||
1625522|NCT02220725|2985489|Superiority||Hodges-Lehmann Estimate of Shift|-18.0|||<|0.0001|2-Sided|95.0|-23.05|-12.73|||2-sided test exact Wilcoxon rank-sum tes||||
1625523|NCT02220725|2985491|Superiority||Hodges-Lehman estimate of shift|-74.45|||<|0.0001|2-Sided|95.0|-78.92|-64.45|||2-sided test exact Wilcoxon rank-sum tes||||
1625524|NCT02220725|2985492|Superiority||Hodges-Lehman estimate of shift|-51.87|||<|0.0001|2-Sided|95.0|-57.95|-47.03|||2-sided test exact Wilcoxon rank-sum tes||||
1625525|NCT02220725|2985492|Superiority||Hodges-Lehman estimate of shift|-70.14|||<|0.0001|2-Sided|95.0|-85.43|-65.91|||2-sided test exact Wilcoxon rank-sum tes||||
1625526|NCT02219932|2985498|Superiority or Other||LS Mean Difference|0.74|Standard Error of the Mean|0.573||0.197|2-Sided|95.0|-0.38|1.86|||mixed model for repeated measures||||
1625527|NCT02219932|2985499|Superiority or Other||LS Mean Difference|0.41|Standard Error of the Mean|0.277||0.141|2-Sided|95.0|-0.13|0.95|||mixed model for repeated measures||||
1625528|NCT02219932|2985500|Superiority or Other||LS Mean Difference|-3.31|Standard Error of the Mean|0.925|<|0.001|2-Sided|95.0|-5.13|-1.5|||mixed model for repeated measures||||
1625529|NCT02219932|2985501|Superiority or Other||Relative Risk|1.25|||||2-Sided|95.0|0.99|1.51||||||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.|
1625530|NCT02219932|2985501|Superiority or Other||Risk Difference for Adjusted Proportions|0.092|||||2-Sided|95.0|0.009|0.175||||||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.|
1625531|NCT02219932|2985501|Superiority or Other||Odds Ratio (OR)|1.46||||0.03|2-Sided|95.0|1.04|2.07|||Regression, Logistic|||Based on logistic regression, adjusting for baseline TUG speed, screening EDSS score and prior aminopyridine. Missing data were handled using multiple imputation.|
1625532|NCT02219932|2985502|Superiority or Other||Relative Risk|1.38|||||2-Sided|95.0|1.06|1.7||||||Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.|
1625533|NCT02219932|2985502|Superiority or Other||Risk Difference for Adjusted Proportions|0.104|||||2-Sided|95.0|0.03|0.178||||||Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.|
1625534|NCT02219932|2985502|Superiority or Other||Odds Ratio (OR)|1.61||||0.006|2-Sided|95.0|1.15|2.26|||Regression, Logistic||fampridine vs. placebo|Based on logistic regression, adjusting for baseline MSWS-12 score, baseline TUG speed, age, screening Expanded Disability Status Scale (EDSS) score and prior aminopyridine. Missing data handled by multiple imputation. Hypothesis testing was performed at the 2-sided 5% significance level overall, with adjustment for testing multiple secondary endpoints.|
1625535|NCT02219685|2985517|Superiority or Other|||||||0.3388||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA||||
1625536|NCT02219685|2985518|Superiority or Other|||||||0.987||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA||||
1625537|NCT02219685|2985519|Superiority or Other|||||||0.2677||||||The p-value was ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA||||
1625538|NCT02219685|2985520|Superiority or Other|||||||0.7007||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA||||
1625539|NCT02219685|2985521|Superiority or Other|||||||0.0795||||||The p-value was from ANCOVA model for change from baseline with treatment group and baseline as covariates.|ANCOVA||||
1625540|NCT02219685|2985522|Superiority or Other|||||||0.59||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided||||
1625541|NCT02219685|2985522|Superiority or Other|||||||0.21||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided||||
1625542|NCT02219685|2985522|Superiority or Other|||||||0.7||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided||||
1625543|NCT02219685|2985523|Superiority or Other|||||||0.63||||||This p-value for treatment effect on dorsolateral prefrontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided||||
1625544|NCT02219685|2985523|Superiority or Other|||||||0.57||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided||||
1625545|NCT02219685|2985523|Superiority or Other|||||||0.54||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided||||
1626592|NCT02197130|2987360|Superiority or Other||Mean Difference (Net)|1.54|Standard Error of the Mean|0.515||0.003|2-Sided|90.0|0.69|2.39|||MMRM|||Week 13|
1625547|NCT02219685|2985524|Superiority or Other|||||||0.48||||||This p-value for treatment effect on frontal cortex was based on a two sample t-test assuming equal variances.|t-test, 2 sided||||
1625548|NCT02219685|2985524|Superiority or Other|||||||0.58||||||This p-value for treatment effect on basal ganglia was based on a two sample t-test assuming equal variances.|t-test, 2 sided||||
1625549|NCT02219516|2985525|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|21.2|||||2-Sided|90.0|13.6|32.8|||||||
1625550|NCT02219516|2985525|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|58.3|||||2-Sided|90.0|30.2|113.0|||||||
1625551|NCT02219516|2985525|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|95.4|||||2-Sided|90.0|60.6|150.0|||||||
1625552|NCT02219516|2985526|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|43.5|||||2-Sided|90.0|27.5|68.7|||||||
1625553|NCT02219516|2985526|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|40.3|||||2-Sided|90.0|27.3|59.5|||||||
1625554|NCT02219516|2985526|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|80.8|||||2-Sided|90.0|57.9|113.0|||||||
1625555|NCT02219516|2985527|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|47.8|||||2-Sided|90.0|31.5|72.5|||||||
1625556|NCT02219516|2985527|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|45.1|||||2-Sided|90.0|34.9|58.3|||||||
1625557|NCT02219516|2985527|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|76.0|||||2-Sided|90.0|57.1|101.0|||||||
1625558|NCT02219516|2985529|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|230.0|||||2-Sided|90.0|146.0|363.0|||||||
1625559|NCT02219516|2985529|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|248.0|||||2-Sided|90.0|168.0|366.0|||||||
1625560|NCT02219516|2985529|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|124.0|||||2-Sided|90.0|88.8|173.0|||||||
1625561|NCT02219516|2985530|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|211.0|||||2-Sided|90.0|139.0|319.0|||||||
1625562|NCT02219516|2985530|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|222.0|||||2-Sided|90.0|171.0|287.0|||||||
1625563|NCT02219516|2985530|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|131.0|||||2-Sided|90.0|98.6|174.0|||||||
1625564|NCT02219516|2985532|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|228.0|||||2-Sided|90.0|155.0|336.0|||||||
1625565|NCT02219516|2985532|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|173.0|||||2-Sided|90.0|131.0|230.0|||||||
1625566|NCT02219516|2985532|Non-Inferiority or Equivalence|Informal BE assessment using the conventional BE limits of 80% to 125%.|Geometric Least Squares Mean Ratio (%)|153.0|||||2-Sided|90.0|115.0|203.0|||||||
1625567|NCT02219503|2985537|Superiority or Other||Percentage of Participants|100.0|||||2-Sided|95.0|94.0|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.|The superiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Superiority was declared if the lower confidence bound was greater than 83.2%.|
1625568|NCT02219503|2985537|Non-Inferiority or Equivalence|The non-inferiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Non-inferiority was to be declared if the lower confidence bound was greater than 72.7%.|Percentage of Participants|100.0|||||2-Sided|95.0|94.0|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.||
1625569|NCT02219087|2985566|Superiority or Other|||||||0.438|||||||Wilcoxon (Mann-Whitney)||||
1625570|NCT02219087|2985567|Superiority or Other|||||||0.843|||||||Chi-squared||||
1625571|NCT02219087|2985568|Superiority or Other|||||||0.385|||||||t-test, 2 sided||||
1625572|NCT02219087|2985569|Superiority or Other|||||||0.208|||||||t-test, 2 sided||||
1625573|NCT02219087|2985570|Superiority or Other|||||||0.343|||||||t-test, 2 sided||||
1625574|NCT02219087|2985571|Superiority or Other|||||||0.137|||||||t-test, 2 sided||||
1625575|NCT02219048|2985574|Superiority or Other||Mean Difference (Final Values)|-1.212|Standard Error of the Mean|10.317|||2-Sided|90.0|-18.52|16.096||||||Evening PEF: CFB Averaged Over 4 Weeks|
1625576|NCT02219048|2985574|Superiority or Other||Mean Difference (Final Values)|-0.445|Standard Error of the Mean|13.573|||2-Sided|90.0|-23.245|22.356||||||Evening PEF: CFB at Week 4|
1625577|NCT02219048|2985574|Superiority or Other||Mean Difference (Final Values)|-8.374|Standard Error of the Mean|11.652|||2-Sided|90.0|-27.933|11.185||||||Evening PEF: CFB at Week 3|
1625578|NCT02219048|2985574|Superiority or Other||Mean Difference (Final Values)|2.834|Standard Error of the Mean|9.956|||2-Sided|90.0|-13.871|19.54||||||Evening PEF: CFB at Week 2|
1625579|NCT02219048|2985574|Superiority or Other||Mean Difference (Final Values)|1.135|Standard Error of the Mean|10.961|||2-Sided|90.0|-17.248|19.519||||||Evening PEF: CFB at Week 1|
1625580|NCT02219048|2985574|Superiority or Other||Mean Difference (Final Values)|2.299|Standard Error of the Mean|10.503|||2-Sided|90.0|-15.323|19.92||||||Morning PEF: CFB Averaged Over 4 Weeks|
1626692|NCT02194933|2987775|Superiority or Other|||||||0.2113|||||||Mixed Models Analysis||||
1625581|NCT02219048|2985574|Superiority or Other||Mean Difference (Final Values)|-4.368|Standard Error of the Mean|12.92|||2-Sided|90.0|-26.069|17.333||||||Morning PEF: CFB at Week 4|
1625582|NCT02219048|2985574|Superiority or Other||Mean Difference (Final Values)|0.954|Standard Error of the Mean|11.673|||2-Sided|90.0|-18.644|20.552||||||Morning PEF: CFB at Week 3|
1625583|NCT02219048|2985574|Superiority or Other||Mean Difference (Final Values)|6.591|Standard Error of the Mean|12.228|||2-Sided|90.0|-13.926|27.108||||||Morning PEF: CFB at Week 2|
1625584|NCT02219048|2985574|Superiority or Other||Mean Difference (Final Values)|6.017|Standard Error of the Mean|10.003|||2-Sided|90.0|-10.76|22.794||||||Morning PEF: CFB at Week 1|
1625585|NCT02219048|2985576|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.116|||2-Sided|90.0|-0.285|0.106||||||Change From Baseline Averaged Over Week 1 to 4|
1625586|NCT02219048|2985579|Superiority or Other||Median Difference (Net)|-0.0837|Standard Error of the Mean|0.0742|||2-Sided|90.0|-0.2081|0.0406||||||Change From Baseline Over Week 1 to 4|
1625587|NCT02219048|2985579|Superiority or Other||Mean Difference (Net)|-0.058|Standard Error of the Mean|0.0829|||2-Sided|90.0|-0.1971|0.0812||||||Change From Baseline at Week 4|
1625588|NCT02219048|2985579|Superiority or Other||Mean Difference (Net)|-0.1131|Standard Error of the Mean|0.0837|||2-Sided|90.0|-0.2536|0.0274||||||Change From Baseline at Week 3|
1625589|NCT02219048|2985579|Superiority or Other||Mean Difference (Net)|-0.092|Standard Error of the Mean|0.086|||2-Sided|90.0|-0.2362|0.0523||||||Change From Baseline at Week 2|
1625590|NCT02219048|2985579|Superiority or Other||Mean Difference (Net)|-0.0719|Standard Error of the Mean|0.0909|||2-Sided|90.0|-0.2243|0.0805||||||Change From Baseline at Week 1|
1625591|NCT02218736|2985585|Superiority|||||||0.43|||||||t-test, 1 sided||||
1625592|NCT02218736|2985586|Superiority|||||||0.0345|||||||t-test, 1 sided||||
1625593|NCT02218736|2985587|Superiority|||||||0.0095|||||||t-test, 1 sided||||
1625594|NCT02218697|2985603|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.34|||||2-Sided|95.0|1.05|1.7|||||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 19A serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.|
1625595|NCT02218697|2985603|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.2|||||2-Sided|95.0|0.91|1.57|||||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 14 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.|
1625596|NCT02218697|2985603|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.24|||||2-Sided|95.0|0.95|1.63|||||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 7F serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.|
1625597|NCT02218697|2985603|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.26|||||2-Sided|95.0|0.98|1.62|||||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 04 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.|
1625598|NCT02218697|2985603|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.18|||||2-Sided|95.0|0.96|1.45|||||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 03 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.|
1625599|NCT02218697|2985603|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.|Adjusted GMC ratio|1.14|||||2-Sided|95.0|0.86|1.5|||||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.|Anti-pneumococcal antibody concentrations for Polysaccharide 01 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.|
1625623|NCT02218372|2985638|Other||adjusted treatment difference|21.3|||||2-Sided|95.0|4.5|37.7||||||Adjusted difference of GC at EOT +9 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.|
1626693|NCT02194933|2987775|Superiority or Other|||||||0.1322|||||||Mixed Models Analysis||||
1625600|NCT02218697|2985604|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|0.99|||||2-Sided|95.0|0.84|1.16|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for Yamagata strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.|
1625601|NCT02218697|2985604|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|1.17|||||2-Sided|95.0|0.98|1.4|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for Victoria strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.|
1625602|NCT02218697|2985604|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|0.97|||||2-Sided|95.0|0.78|1.21|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for H3N2 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.|
1625603|NCT02218697|2985604|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.|Adjusted GMT ratio|1.13|||||2-Sided|95.0|0.88|1.46|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for H1N1 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.|
1625604|NCT02218541|2985605|Equivalence|No power calculation was done as this was a pilot study.||||||1||||||This statistical analysis applies to Yes Provisional Crown fit|Binomial|The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change|||
1625605|NCT02218541|2985606|Other|||||||0.039||||||This statistical analysis applies to Yes bleeding|Binomial|The statistical analysis was changed during the analysis phase but the protocol was not amended to reflect this change|||
1625606|NCT02218541|2985607|Other|||||||1||||||threshold for significance will be p-value <0.05|Fisher Exact||||
1625607|NCT02218463|2985608|Superiority|||||||0.425|||||||ANOVA|||Treatment by time interaction|
1625608|NCT02218463|2985608|Superiority|||||||0.37|||||||ANOVA|||Treatment Effect|
1625609|NCT02218463|2985608|Superiority|||||||0.0001|||||||ANOVA|||Time Effect|
1625610|NCT02218463|2985609|Superiority|||||||0.206|||||||Fisher Exact|||Assessment of complete resolution between the 2 study arms.|
1625611|NCT02218372|2985626|Other|||||||0.023|||||||Log Rank|||Time to recurrence of CDAD.|
1625612|NCT02218372|2985627|Other|||||||0.579|||||||Log Rank|||Time to resolution of diarrhea.|
1625613|NCT02218372|2985628|Other|Newcombe 95% CIs presented for adjusted treatment difference.|adjusted treatment difference|-15.8|||||2-Sided|95.0|-34.5|0.5||||||Adjusted difference of CDAD recurrence at EOS/EOT +30 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.|
1625614|NCT02218372|2985629|Other||adjusted treatment difference|18.8|||||2-Sided|95.0|1.5|35.3||||||Adjusted difference of GC at EOS (EOT +30 days). Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.|
1625615|NCT02218372|2985630|Other||adjusted treatment difference|15.8|||||2-Sided|95.0|-0.5|34.5||||||Adjusted difference of SCR at EOS (EOT +30 days). Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.|
1625616|NCT02218372|2985631|Other||adjusted treatment difference|-15.8|||||2-Sided|95.0|-34.5|0.5||||||Adjusted difference of CDAD Recurrence at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.|
1625617|NCT02218372|2985632|Other||adjusted treatment difference|18.8|||||2-Sided|95.0|1.5|35.3||||||Adjusted difference of GC at EOT +23 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.|
1625618|NCT02218372|2985633|Other||adjusted treatment difference|15.8|||||2-Sided|95.0|-0.5|34.5||||||Adjusted difference of SCR at EOT +23 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.|
1625619|NCT02218372|2985634|Other||adjusted treatment difference|-17.2|||||2-Sided|95.0|-35.6|-1.9||||||Adjusted difference of CDAD Recurrence at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.|
1625620|NCT02218372|2985635|Other||adjusted treatment difference|19.4|||||2-Sided|95.0|2.3|35.9||||||Adjusted difference of GC at EOT +16 days. Adjusted treatment difference of rates was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.|
1625621|NCT02218372|2985636|Other||adjusted treatment difference|17.2|||||2-Sided|95.0|1.9|35.6||||||Adjusted difference of SCR at EOT +16 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.|
1625622|NCT02218372|2985637|Other||adjusted treatment difference|-16.3|||||2-Sided|95.0|-34.2|-1.8||||||Adjusted difference of CDAD recurrence at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.|
1625624|NCT02218372|2985639|Other||adjusted treatment difference|16.3|||||2-Sided|95.0|1.8|34.2||||||Adjusted difference of SCR at EOT +9 days. Adjusted treatment difference of proportions was calculated using a stratified CMH method. Newcombe 95% CIs presented for adjusted treatment difference.|
1625625|NCT02218372|2985640|Other||adjusted treatment difference|7.5|||||2-Sided|95.0|-7.4|23.9||||||Adjusted difference of CCR at EOT + 2 Days. Adjusted treatment difference of proportions was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. Newcombe 95% confidence intervals (CIs) presented for adjusted treatment difference.|
1625626|NCT02218320|2985643|Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1625627|NCT02218203|2985649|Other|We report the interaction between the lidocaine dose response and dextromethorphan dose response. The type of statistical test was a linear regression model with Chi-square test.|Lidocaine dose*dextromethorphan dose|0.0042|Standard Error of the Mean|0.002||0.0322|2-Sided|95.0|0.0004|0.0081|||Pearson’s Chi-squared test||The estimated value is an estimated interaction term, and not a P-value.|We performed a lidocaine dose response clinical trial nested within a dextromethorphan clinical trial to evaluate a potential interaction between lidocaine dose and dextromethorphan dose (pain intensity; Gracely scale).|
1625628|NCT02218008|2985660|Superiority|The primary hypotheses were evaluated using a 6-step, fixed sequence approach to adjust for multiple comparisons. Using this method, hypothesis testing (using alpha=0.05) continued through the sequence until statistical significance was not achieved. Steps 1-3 included testing the ALKS 5461 2mg/2mg dose vs placebo for the 3 primary endpoints.|Least Squares Mean Difference|-1.7||||0.076|2-Sided|95.0|-3.6|0.2||ALKS 5461 is compared to placebo within each of the 2 stages, and resulting treatment effects from each stage are combined for a single hypothesis test using equal weights of 0.5 for both stages.|Mixed Models Analysis|||ALKS 5461 is compared to placebo within each of the 2 stages (i.e., ALKS 5461 2/2 S1 vs Placebo S1; and ALKS 5461 2/2 S2 vs Placebo S2). Efficacy was estimated as a weighted average across 2 stages using equal weights.|
1625629|NCT02218008|2985661|Superiority|Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Least Squares Mean Difference|-1.9||||0.026|2-Sided|95.0|-3.6|-0.2||ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Mixed Models Analysis||Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.|
1625630|NCT02218008|2985662|Superiority||Least Squares Mean Difference|-1.5||||0.018|2-Sided|95.0|-2.7|-0.3||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 1/1 compared to placebo.|
1625631|NCT02217904|2985676|Superiority||Posterior mean difference|-1.18|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was >99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.|
1625632|NCT02217904|2985676|Superiority||Posterior mean difference|-1.28|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was >99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.|
1625633|NCT02217904|2985676|Superiority||Posterior mean difference|-1.57|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was >99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.|
1625634|NCT02217904|2985676|Superiority||Posterior mean difference|-1.32|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was >99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.|
1625663|NCT02216214|2985863|Superiority||Odds Ratio (OR)|1.452||||0.012||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Sleep. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (<75, >=75 years), and country as fixed factors and baseline value as a covariate.|
1626144|NCT02207244|2986568|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).|
1625635|NCT02217904|2985676|Superiority||Posterior mean difference|-1.64|||||||||||||Posterior Probability (PP) of true mean difference in the plasma HIV-1 RNA change from baseline between islatravir and placebo at least 0.5 log10 copies/mL was >99%.|Adjusted by Placebo data pooled from historical placebo data from recent monotherapy studies in HIV-1 infected participants (NCT00100048, NCT01466985, NCT01152255, and NCT01353898) and fitted with a longitudinal data analysis (LDA) model containing fixed effects for study and time, and a random effect for participants. LS mean of pooled historical placebo data was -0.03 log10 copies/mL (95% CI -014, 0.09) change from baseline at 168 hours post dose.|
1625636|NCT02217475|2985773|Superiority||Odds Ratio (OR)|1.154||||0.7474|2-Sided|95.0|0.484|2.752|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.|||
1625637|NCT02217475|2985774|Superiority||Odds Ratio (OR)|2.201||||0.0234|2-Sided|95.0|1.113|4.352|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.|||
1625638|NCT02217475|2985775|Superiority||Odds Ratio (OR)|1.142||||0.8434|2-Sided|95.0|0.305|4.277|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.|||
1625639|NCT02217475|2985776|Superiority||Odds Ratio (OR)|1.396||||0.4941|2-Sided|95.0|0.537|3.628|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.|||
1625640|NCT02217475|2985777|Superiority||Odds Ratio (OR)|1.249||||0.592|2-Sided|95.0|0.553|2.821|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.|||
1625641|NCT02217475|2985778|Superiority||Odds Ratio (OR)|1.934||||0.0388|2-Sided|95.0|1.035|3.614|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.|||
1625642|NCT02217475|2985779|Superiority||Odds Ratio (OR)|0.816||||0.5194|2-Sided|95.0|0.439|1.516|||Regression, Logistic|Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.|||
1625643|NCT02217436|2985780|Superiority|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1625644|NCT02217436|2985781|Superiority|||||||0.98|||||||Wilcoxon (Mann-Whitney)||||
1625645|NCT02217410|2985789|Other||Mean Difference (Final Values)|0.093||||0.8821|2-Sided|95.0|-0.087|0.273|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is < 20%.|Month 12||
1625646|NCT02217410|2985789|Other||Mean Difference (Final Values)|0.093||||0.8822|2-Sided|95.0|-0.085|0.272|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is < 20%.|Month 9||
1625647|NCT02217410|2985789|Other||Mean Difference (Final Values)|0.093||||0.8836|2-Sided|95.0|-0.084|0.271|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is < 20%.|Month 6||
1625648|NCT02217410|2985789|Other||Mean Difference (Final Values)|0.095||||0.8976|2-Sided|95.0|-0.067|0.263|||Bayesian posterior probability|Posterior probability that the composite efficacy failure difference between CFZ533 and Tac is < 20%.|Month 3||
1625649|NCT02216812|2985799|Other|||||||0.63|||||||Regression, Linear|||We tested the null hypothesis that there is no difference in DPC six weeks after fracture of the distal radius between patients taking vitamin C and placebo.|
1625650|NCT02216695|2985803|Superiority or Other||Odds Ratio (OR)|1.13|||||2-Sided|95.0|1.07|1.18|||||This is the OR for 2008-13 discharge period with 2003-08 as the reference group||
1625651|NCT02216695|2985803|Superiority or Other||Odds Ratio (OR)|1.2|||||2-Sided|95.0|1.1|1.3|||||This is the OR for 1998-2003 discharge period with 2003-08 as the reference group||
1625652|NCT02216695|2985804|Superiority or Other||Odds Ratio (OR)|2.03|||||2-Sided|95.0|1.89|2.19|||||This is OR for age group equal to greater than 85 years age group with < 65 years as reference||
1625653|NCT02216695|2985804|Superiority or Other||Odds Ratio (OR)|1.72|||||2-Sided|95.0|1.66|1.79|||||This is OR for age group 75 to 84 years age group with < 65 years as reference||
1625654|NCT02216695|2985804|Superiority or Other||Odds Ratio (OR)|1.35|||||2-Sided|95.0|1.3|1.4|||||This is OR for 65 to 74 years age group with < 65 years as the reference group||
1625655|NCT02216591|2985807|Superiority|||||||0.41|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = .72, p = 0.410|||
1625656|NCT02216591|2985808|Superiority|||||||0.274|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was not significant, F(1,16) = 1.29, p = 0.274|||
1625657|NCT02216591|2985809|Superiority|||||||0.013|||||||ANCOVA|Mixed-model general linear model with age and education included as covariates. Time x arm interaction was significant, F(1,16) = 7.76, p = 0.013.|||
1625658|NCT02216422|2985847|Superiority or Other||Percentage of Participants|100.0|||||2-Sided|95.0|90.4|100.0|||||95% confidence interval (CI) was calculated using Wilson score method.||
1625659|NCT02216214|2985859|Superiority|||||||0.54||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA||||
1625660|NCT02216214|2985861|Superiority||Odds Ratio (OR)|1.597||||0.003||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (<75, >=75 years), and country as fixed factors and baseline value as a covariate.|
1625661|NCT02216214|2985862|Superiority||Odds Ratio (OR)|1.634||||0.001||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (<75, >=75 years), and country as fixed factors and baseline value as a covariate.|
1625662|NCT02216214|2985863|Superiority||Odds Ratio (OR)|1.116||||0.602||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Social. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (<75, >=75 years), and country as fixed factors and baseline value as a covariate.|
1625713|NCT02215252|2985952|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.39|||2-Sided|90.0|-0.86|0.43||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4|
1625664|NCT02216214|2985863|Superiority||Odds Ratio (OR)|1.327||||0.07||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Concern. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (<75, >=75 years), and country as fixed factors and baseline value as a covariate.|
1625665|NCT02216214|2985863|Superiority||Odds Ratio (OR)|1.39||||0.034||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||HRQL Subscale - Coping. Odds Ratio: Logistic regression was performed with treatment group, sex, age group (<75, >=75 years), and country as fixed factors and baseline value as a covariate.|
1625666|NCT02216214|2985864|Superiority||Odds Ratio (OR)|1.501||||0.012||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (<75, >=75 years), and country as fixed factors and baseline value as a covariate.|
1625667|NCT02216214|2985865|Superiority||Odds Ratio (OR)|1.775|||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (<75, >=75 years), and country as fixed factors and baseline value as a covariate.|
1625668|NCT02216214|2985866|Superiority||Odds Ratio (OR)|1.5||||0.005||||||P-value compares the Mirabegron group to the placebo group.|Regression, Logistic|||Odds Ratio: Logistic regression was performed with treatment group, sex, age group (<75, >=75 years), and country as fixed factors and baseline value as a covariate.|
1625669|NCT02216214|2985868|Superiority||Rate Ratio|0.69||||0.002|2-Sided|95.0|0.54|0.87||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||EOT: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (<75, >=75 years) and country as factors and number of valid diary days as the offset variable.|
1625670|NCT02216214|2985868|Superiority||Rate Ratio|0.81||||0.043|2-Sided|95.0|0.66|0.99||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||Week 8: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (<75, >=75 years) and country as factors and number of valid diary days as the offset variable.|
1625671|NCT02216214|2985868|Superiority||Rate Ratio|0.8||||0.014|2-Sided|95.0|0.67|0.96||P-value compares the Mirabegron group to the placebo group.|Negative Binomial Regression Model|||Week 4: Rate ratio for the number of incontinence episodes reported during 3-day diary prior to each visit between mirabegron group vs placebo group is calculated from a negative binomial regression model including treatment group, sex, age group (<75, >=75 years) and country as factors and number of valid diary days as the offset variable.|
1625672|NCT02216214|2985869|Superiority|||||||0.755||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA||||
1625673|NCT02216214|2985870|Superiority|||||||0.002||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA||||
1625674|NCT02216214|2985871|Superiority|||||||0.614||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Social Subscale Score|
1625675|NCT02216214|2985871|Superiority|||||||0.006||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Sleep Subscale Score|
1625676|NCT02216214|2985871|Superiority|||||||0.01||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Concern Subscale Score|
1625677|NCT02216214|2985871|Superiority|||||||0.019||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Coping Subscale Score|
1625678|NCT02216214|2985872|Superiority||||||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA||||
1625679|NCT02216214|2985873|Superiority|||||||0.165||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA||||
1625680|NCT02216214|2985874|Superiority|||||||0.317||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA||||
1625681|NCT02216214|2985875|Superiority|||||||0.068||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA||||
1625682|NCT02216214|2985876|Superiority||||||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|Stratified Rank ANCOVA||||
1625683|NCT02216214|2985877|Superiority||||||<|0.001||||||P-value compares the Mirabegron group to the placebo group.|ANCOVA||||
1625684|NCT02216214|2985878|Superiority||LSM Difference|-0.3|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.5|-0.2||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (<75, >=75 years) and country as fixed factors and baseline value as a covariate.|
1625685|NCT02216214|2985879|Superiority||LSM Difference|2.72|Standard Error of the Mean|1.07||0.011|2-Sided|95.0|0.62|4.83||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (<75, >=75 years) and country as fixed factors and baseline value as a covariate.|
1625686|NCT02216214|2985880|Superiority||LSM Difference|-5.15|Standard Error of the Mean|1.37|<|0.001|2-Sided|95.0|-7.84|-2.46||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (<75, >=75 years) and country as fixed factors and baseline value as a covariate.|
1625687|NCT02216214|2985881|Superiority||LSM Difference|13.68|Standard Error of the Mean|4.45||0.002|2-Sided|95.0|4.95|22.42||P-value compares the Mirabegron group to the placebo group.|stratified rank ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the stratified rank ANCOVA model with treatment group, sex, age group (<75, >=75 years) and country as fixed factors and baseline value as a covariate.|
1625714|NCT02215252|2985953|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.44|||2-Sided|90.0|-1.43|0.04||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4|
1626694|NCT02194933|2987776|Superiority or Other|||||||0.1211|||||||Mixed Models Analysis||||
1625688|NCT02216214|2985882|Superiority||LSM Difference|-0.55|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-0.82|-0.27||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (<75, >=75 years) and country as fixed factors and baseline value as a covariate.|
1625689|NCT02216214|2985883|Superiority||Least Squares Mean (LSM) Mean Difference|-0.7|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|-1.0|-0.3||P-value compares the Mirabegron group to the placebo group.|ANCOVA|||Difference vs. Mirabegron: Differences of adjusted change from baseline values as well as the 95% CIs were generated from the ANCOVA model with treatment group, sex, age group (<75, >=75 years) and country as fixed factors and baseline value as a covariate.|
1625690|NCT02216123|2985914|Other||Hazard Ratio (HR)|0.815|||||2-Sided|95.0|0.442|1.503|||||Hazard ratio was estimated from Cox Proportional Hazards Model with treatment and region as covariates. A hazard ratio<1 indicates a lower chance of relapse with TQ+CQ compared to PQ+CQ.||
1625691|NCT02216123|2985915|Other||Hazard Ratio (HR)|0.984||||||95.0|0.577|1.678|||||Hazards ratio was estimated from Cox Proportional Hazards Model with treatment and region as covariates. A hazard ratio <1 indicates a lower chance of relapse with TQ+CQ compared to PQ+CQ.||
1625692|NCT02216123|2985917|Other||Mean Difference (Final Values)|1.23|||||2-Sided|95.0|-4.161|4.982|||||Confidence interval for the treatment difference was based on the Newcombe method. Percent treatment difference (TQ+CQ-PQ+CQ) has been presented.||
1625693|NCT02215616|2985936|Other||Least square (LS) mean difference|0.78||||0.4853|2-Sided|95.0|-1.42|2.98||Threshold for significance at 0.045 level.|Mixed Models Analysis|||Analysis was performed using Mixed Model Repeated Measures model (MMRM) with treatment group (3 levels: placebo, laquinimod 0.5 mg and laquinimod 1 mg), categorical week (4 levels: Weeks 4, 13, 26, and 52), treatment by week interaction, country, TMS baseline value and TMS baseline by week interaction as fixed effects. Unstructured variance-covariance structure was used in the initial model.|
1625694|NCT02215252|2985940|Superiority or Other||Mean Difference (Final Values)|-2.42|Standard Error of the Mean|5.4|||2-Sided|90.0|-11.38|6.54||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.|
1625695|NCT02215252|2985940|Superiority or Other||Mean Difference (Final Values)|11.55|Standard Error of the Mean|5.19|||2-Sided|90.0|2.94|20.17||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.|
1625696|NCT02215252|2985941|Superiority or Other||Mean Difference (Final Values)|0.75|Standard Error of the Mean|3.14|||2-Sided|90.0|-4.46|5.95||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.|
1625697|NCT02215252|2985941|Superiority or Other||Mean Difference (Final Values)|7.99|Standard Error of the Mean|3.03|||2-Sided|90.0|2.98|13.01||||||Statistical analysis is only for Week 4. Mixed Model Repeated Measures analysis including all data up to Week 4.|
1625698|NCT02215252|2985945|Superiority or Other||Mean Difference (Final Values)|611.0|Standard Error of the Mean|812.0|||2-Sided|90.0|-735.0|1956.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.|
1625699|NCT02215252|2985945|Superiority or Other||Mean Difference (Final Values)|192.0|Standard Error of the Mean|816.0|||2-Sided|90.0|-1161.0|1544.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.|
1625700|NCT02215252|2985946|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.34|||2-Sided|90.0|-1.57|-0.43||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.|
1625701|NCT02215252|2985946|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|0.34|||2-Sided|90.0|-1.16|-0.02||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.|
1625702|NCT02215252|2985947|Superiority or Other||Odds Ratio (OR)|0.5|||||2-Sided|90.0|0.24|1.07||||||Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.|
1625703|NCT02215252|2985947|Superiority or Other||Odds Ratio (OR)|0.7|||||2-Sided|90.0|0.34|1.45||||||Statistical analysis is only for Week 4. Proportional Odds Logistic Regression including all data up to week 4.|
1625704|NCT02215252|2985948|Superiority or Other||Mean Difference (Final Values)|-5.61|Standard Error of the Mean|2.99|||2-Sided|90.0|-10.57|-0.66||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.|
1625705|NCT02215252|2985948|Superiority or Other||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|2.92|||2-Sided|90.0|-5.12|4.57||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.|
1625706|NCT02215252|2985949|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.45|||2-Sided|90.0|-1.0|0.51||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.|
1625707|NCT02215252|2985949|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.45|||2-Sided|90.0|-1.09|0.39||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.|
1625708|NCT02215252|2985950|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.36|||2-Sided|90.0|-1.05|0.13||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.|
1625709|NCT02215252|2985950|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.35|||2-Sided|90.0|-0.49|0.67||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.|
1625710|NCT02215252|2985951|Superiority or Other||Mean Difference (Final Values)|-0.58|Standard Error of the Mean|0.47|||2-Sided|90.0|-1.36|0.2||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.|
1625711|NCT02215252|2985951|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.46|||2-Sided|90.0|-0.87|0.67||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.|
1625712|NCT02215252|2985952|Superiority or Other||Mean Difference (Final Values)|-0.66|Standard Error of the Mean|0.4|||2-Sided|90.0|-1.33|0.0||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4|
1626695|NCT02194933|2987776|Superiority or Other|||||||0.1595|||||||Mixed Models Analysis||||
1625715|NCT02215252|2985953|Superiority or Other||Mean Difference (Final Values)|-1.04|Standard Error of the Mean|0.43|||2-Sided|90.0|-1.75|-0.32||||||Statistical analysis is only for Week 4. Mixed Models Repeated Measures analysis including all data up to Week 4.|
1625716|NCT02215252|2985954|Superiority or Other||Odds Ratio (OR)|4.75|||||2-Sided|90.0|1.43|15.81||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.|
1625717|NCT02215252|2985954|Superiority or Other||Odds Ratio (OR)|1.25|||||2-Sided|90.0|0.33|4.74||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.|
1625718|NCT02215252|2985955|Superiority or Other||Odds Ratio (OR)|2.63|||||2-Sided|90.0|1.06|6.56||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.|
1625719|NCT02215252|2985955|Superiority or Other||Odds Ratio (OR)|1.91|||||2-Sided|90.0|0.78|4.69||||||Statistical analysis is only for Week 4. Logistic Regression using all data up to Week 4.|
1625720|NCT02215252|2985956|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Deviation|0.23|||2-Sided|90.0|-0.91|-0.2||||||Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.|
1625721|NCT02215252|2985956|Superiority or Other||Mean Difference (Final Values)|-0.41|Standard Deviation|0.355|||2-Sided|90.0|-1.0|0.17||||||Statistical analysis is only for week 4. Mixed Models Repeated Measures analysis including all data up to Week 4 ,incorporating Bayesian priors separately on the placebo response and pregabalin effect.|
1625722|NCT02214225|2985996|Superiority or Other||Difference in SCR (B/VIC) ≥ 65 years|11.9|||||2-Sided|95.0|7.7|16.0|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was > 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage.|
1625723|NCT02214225|2985996|Superiority or Other||Difference in SCR (B/YAM) ≥ 65 years|8.0|||||2-Sided|95.0|4.3|11.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was > 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage|
1625724|NCT02214225|2985996|Superiority or Other||Difference in SCR (B/VIC) 18 through 64y|28.6|||||2-Sided|95.0|23.1|34.1|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was > 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage|
1625725|NCT02214225|2985996|Superiority or Other||Difference in SCR (B/YAM) 18 through 64y|22.9|||||2-Sided|95.0|17.7|28.2|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was > 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage|
1625726|NCT02214225|2985996|Superiority or Other||Difference in SCR (B/VIC) overall|20.1|||||2-Sided|95.0|16.5|23.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was > 0.|Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage|
1625727|NCT02214225|2985996|Superiority or Other||Difference in SCR (B/YAM) overall|15.3|||||2-Sided|95.0|12.1|18.6|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was > 0.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage|
1625728|NCT02214225|2985997|Superiority or Other||GMT ratio (B/VIC) ≥ 65 years|1.38|||||2-Sided|95.0|1.27|1.51|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.|
1625729|NCT02214225|2985997|Superiority or Other||GMT ratio (B/YAM) ≥ 65 years|1.3|||||2-Sided|95.0|1.21|1.4|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.|
1626355|NCT02202031|2987018|Superiority|||||||0.5578|||||||ANCOVA|Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.|||
1625730|NCT02214225|2985997|Superiority or Other||GMT ratio (B/VIC) 18 through 64 years|1.76|||||2-Sided|95.0|1.55|2.01|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.|
1625731|NCT02214225|2985997|Superiority or Other||GMT ratio (B/YAM) 18 through 64 years|1.67|||||2-Sided|95.0|1.5|1.87|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.|
1625732|NCT02214225|2985997|Superiority or Other||GMT ratio (B/VIC) overall|1.57|||||2-Sided|95.0|1.45|1.7|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.|
1625733|NCT02214225|2985997|Superiority or Other||GMT ratio (B/YAM) overall|1.47|||||2-Sided|95.0|1.38|1.57|||||Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.|
1625734|NCT02214225|2985998|Non-Inferiority or Equivalence|For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|1.2|||||2-Sided|95.0|-3.7|6.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.|
1625735|NCT02214225|2985998|Non-Inferiority or Equivalence|For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-2.2|||||2-Sided|95.0|-6.3|2.0||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.|
1625736|NCT02214225|2985998|Non-Inferiority or Equivalence|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|1.1|||||2-Sided|95.0|-3.1|5.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.|
1625737|NCT02214225|2985998|Non-Inferiority or Equivalence|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-0.2|||||2-Sided|95.0|-4.4|4.0||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.|
1625738|NCT02214225|2985998|Non-Inferiority or Equivalence|For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|-4.6|||||2-Sided|95.0|-10.5|1.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.|
1625739|NCT02214225|2985998|Non-Inferiority or Equivalence|For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-4.5|||||2-Sided|95.0|-10.3|1.3||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.|
1625740|NCT02214225|2985998|Non-Inferiority or Equivalence|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|-4.6|||||2-Sided|95.0|-9.3|0.2||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.|
1625741|NCT02214225|2985998|Non-Inferiority or Equivalence|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-2.1|||||2-Sided|95.0|-6.9|2.6||||||The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.|
1625786|NCT02213263|2986079|Equivalence|Equivalence was tested within the pre-specified margins of (-16%, 16%) 95% confidence interval.|Difference in ORR|4.66|||||2-Sided|95.0|-4.16|13.47||||||Difference in ORR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.|
1625742|NCT02214225|2985999|Non-Inferiority or Equivalence|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|1.03|||||2-Sided|95.0|0.94|1.14||||||For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|
1625743|NCT02214225|2985999|Non-Inferiority or Equivalence|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.9|||||2-Sided|95.0|0.84|0.97||||||For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|
1625744|NCT02214225|2985999|Non-Inferiority or Equivalence|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.95|||||2-Sided|95.0|0.89|1.02||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|
1625745|NCT02214225|2985999|Non-Inferiority or Equivalence|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.95|||||2-Sided|95.0|0.88|1.02||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|
1625746|NCT02214225|2985999|Non-Inferiority or Equivalence|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|0.86|||||2-Sided|95.0|0.76|0.98||||||For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|
1625747|NCT02214225|2985999|Non-Inferiority or Equivalence|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.86|||||2-Sided|95.0|0.76|0.97||||||For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|
1625748|NCT02214225|2985999|Non-Inferiority or Equivalence|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.91|||||2-Sided|95.0|0.83|0.99||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|
1625749|NCT02214225|2985999|Non-Inferiority or Equivalence|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.93|||||2-Sided|95.0|0.85|1.02||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|
1625750|NCT02214225|2986000|Non-Inferiority or Equivalence|For B/Victoria. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/VIC)|-1.6|||||2-Sided|95.0|-5.6|2.4|||||||
1625751|NCT02214225|2986000|Non-Inferiority or Equivalence|For B/Yamagata. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (B/YAM)|-3.2|||||2-Sided|95.0|-7.0|0.5|||||||
1625752|NCT02214225|2986000|Non-Inferiority or Equivalence|For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H3N2)|-1.7|||||2-Sided|95.0|-5.0|1.6|||||||
1625753|NCT02214225|2986000|Non-Inferiority or Equivalence|For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.|Difference in SCR (A/H1N1)|-1.1|||||2-Sided|95.0|-4.4|2.2|||||||
1625754|NCT02214225|2986001|Non-Inferiority or Equivalence|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/VIC)|0.94|||||2-Sided|95.0|0.86|1.01||||||For B/Victoria strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|
1625811|NCT02210780|2986212|Superiority||Percentage Difference|34.0|||<|0.0001|2-Sided|90.0|24.29|43.75|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate [IGA=3] vs. severe [IGA=4] AD).|
1625755|NCT02214225|2986001|Non-Inferiority or Equivalence|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (B/YAM)|0.87|||||2-Sided|95.0|0.81|0.93||||||For B/Yamagata strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|
1625756|NCT02214225|2986001|Non-Inferiority or Equivalence|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H3N2)|0.93|||||2-Sided|95.0|0.88|0.98||||||For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|
1625757|NCT02214225|2986001|Non-Inferiority or Equivalence|The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.|GMT ratio (A/H1N1)|0.92|||||2-Sided|95.0|0.87|0.98||||||For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|
1625758|NCT02214186|2986002|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1625759|NCT02214186|2986003|Superiority or Other||||||<|0.05|||||||ANOVA|ANOVA for repeated measures.|||
1625760|NCT02214186|2986004|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1625761|NCT02214186|2986005|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test|||
1625762|NCT02214186|2986006|Superiority or Other||||||>|0.05|||||||ANOVA|ANOVA for repeated measures.|||
1625763|NCT02214186|2986007|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test|||
1625764|NCT02214186|2986008|Superiority or Other||||||<|0.05|||||||ANOVA|ANOVA for repeated measures|||
1625765|NCT02214186|2986009|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test|||
1625766|NCT02214186|2986010|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney followed by Friedman test|||
1625767|NCT02214147|2986019|Other|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|2.54|||||2-Sided|90.0|1.84|3.53|||||Least Squares Geometric Mean Ratio=Moderate + Severe Hepatic Impairment/Normal Hepatic Function||
1625768|NCT02214147|2986020|Other|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|3.21|||||2-Sided|90.0|2.33|4.43|||||Least Squares Geometric Mean Ratio=Moderate + Severe Hepatic Impairment/Normal Hepatic Function||
1625769|NCT02214147|2986021|Other|The effect of hepatic impairment on alisertib PK. Combined analysis of moderate and severe hepatic impairment in reference to normal hepatic function.|Least Squares Geometric Mean Ratio|1.42|||||2-Sided|90.0|1.12|1.8|||||Least Squares Geometric Means Ratio= Moderate + Severe Hepatic Impairment/Normal Hepatic Function||
1625770|NCT02213510|2986053|Superiority or Other|||||||1|||||||t-test, 2 sided||||
1625771|NCT02213510|2986054|Superiority or Other|||||||0.858|||||||t-test, 2 sided||||
1625772|NCT02213510|2986055|Superiority or Other|||||||0.588|||||||t-test, 2 sided||||
1625773|NCT02213510|2986056|Superiority or Other|||||||0.651|||||||t-test, 2 sided||||
1625774|NCT02213510|2986057|Superiority or Other|||||||0.51|||||||t-test, 2 sided||||
1625775|NCT02213510|2986058|Superiority or Other|||||||0.646|||||||t-test, 2 sided||||
1625776|NCT02213510|2986059|Superiority or Other|||||||0.462|||||||t-test, 2 sided||||
1625777|NCT02213510|2986060|Superiority or Other|||||||1|||||||t-test, 2 sided||||
1625778|NCT02213510|2986061|Superiority or Other|||||||0.811|||||||t-test, 2 sided||||
1625779|NCT02213510|2986062|Superiority or Other|||||||0.655|||||||t-test, 2 sided||||
1625780|NCT02213510|2986063|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1625781|NCT02213263|2986069|Superiority||Hazard Ratio (HR)|2.94||||0.319|2-Sided|95.0|0.0||Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.|A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to overall survival at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.||
1625782|NCT02213263|2986070|Superiority||Hazard Ratio (HR)|1.492||||0.185|2-Sided|95.0|0.823|2.704||A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to DOR at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.||
1625783|NCT02213263|2986071|Superiority||Mean Difference (Final Values)|-2.31|||||2-Sided|95.0|-11.09|6.5||||||Difference in CR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.|
1625784|NCT02213263|2986072|Superiority||Hazard Ratio (HR)|1.393||||0.189|2-Sided|95.0|0.847|2.291|||Log Rank|A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to PFS at a 2-sided alpha level of 0.05.|Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.||
1625785|NCT02213263|2986073|Superiority||Hazard Ratio (HR)|1.163||||0.45|2-Sided|95.0|0.786|1.72||A log-rank test stratified by follicular lymphoma international prognostic index 2 (FLIPI2) risk was used to compare the treatment groups with respect to TTF at a 2-sided alpha level of 0.05.|Log Rank||Hazard ratio and its confidence intervals (CIs) were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.||
1625787|NCT02212457|2986130|Non-Inferiority or Equivalence|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY_0_2 versus rMenB_0_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.49|||||2-Sided|95.0|0.37|0.66||||||Non-inferiority response against N. meningitidis serogroup B test strain NZ98/254 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.|
1625788|NCT02212457|2986130|Non-Inferiority or Equivalence|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY_0_2 versus rMenB_0_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.66|||||2-Sided|95.0|0.51|0.85||||||Non-inferiority response against N. meningitidis serogroup B test strain 96217 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.|
1625789|NCT02212457|2986130|Non-Inferiority or Equivalence|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY_0_2 versus rMenB_0_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.71|||||2-Sided|95.0|0.54|0.94||||||Non-inferiority response against N. meningitidis serogroup B test strain M07-0241084 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.|
1625790|NCT02212457|2986130|Non-Inferiority or Equivalence|Non-inferiority was concluded when, at 1 month after the second meningococcal vaccination (Visit Month 3), the lower limit of the two-sided 95% confidence interval for the between-group ratios of GMTs (ABCWY_0_2 versus rMenB_0_2) was greater than 0.5 for each of the four serogroup B test strains.|Geometric Mean Ratio|0.74|||||2-Sided|95.0|0.53|1.02||||||Non-inferiority response against N. meningitidis serogroup B test strain M14459 of the MenABCWY vaccine to that of the Bexsero vaccine, administered according to 0, 2 month schedule.|
1625791|NCT02212028|2986146|Superiority or Other|||||||0.005|||||||ANOVA||||
1625792|NCT02212028|2986147|Superiority or Other||Mean Difference (Final Values)|68.0||||0.022|2-Sided|95.0|10.0|126.0|||ANOVA||||
1625793|NCT02211261|2986180|Other||Percentage of Test relative to Reference|51.47|||||2-Sided|90.0|34.26|77.31|||||PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.||
1625794|NCT02211261|2986180|Other||Percentage of Test relative to Reference|34.43|||||2-Sided|90.0|22.57|52.52|||||PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.||
1625795|NCT02211261|2986180|Other||Percentage of Test relative to Reference|32.19|||||2-Sided|90.0|20.67|50.12|||||PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.||
1625796|NCT02211261|2986180|Other||Percentage of Test relative to Reference|7.32|||||2-Sided|90.0|4.7|11.4|||||PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.||
1625797|NCT02211261|2986182|Other||Percentage of Test relative to Reference|53.18|||||2-Sided|90.0|36.36|77.78|||||PF-06293620 6.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.||
1625798|NCT02211261|2986182|Other||Percentage of Test relative to Reference|35.02|||||2-Sided|90.0|23.6|51.95|||||PF-06293620 3.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.||
1625799|NCT02211261|2986182|Other||Percentage of Test relative to Reference|32.73|||||2-Sided|90.0|21.64|49.51|||||PF-06293620 1.0 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.||
1625800|NCT02211261|2986182|Other||Percentage of Test relative to Reference|17.66|||||2-Sided|90.0|8.44|36.95|||||PF-06293620 0.3 mg/kg SC (SAD Cohorts) is Test, PF-06293620 1.0 mg/kg IV (SAD Cohorts) is Reference.||
1625801|NCT02211131|2986192|Other||Hazard Ratio (HR)|0.49||||0.05|2-Sided|80.0|0.3|0.79||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)||
1625802|NCT02211131|2986197|Other||Treatment Difference|14.4||||0.003|2-Sided|80.0|7.4|21.6||The two-sided p-value is based on the Pearson's Chi-square test.|Chi-squared||80% exact CI for binary rate of each arm is calculated using the Clopper Pearson method.||
1625803|NCT02211131|2986198|Other||Treatment Difference|4.3||||0.594|2-Sided|80.0|-6.9|15.3||The two-sided p-value is based on the Pearson's Chi-square test.|Chi-squared||An 80% approximate exact CI for between-arm differences in binary rate is calculated using Wilson's score method with continuity correction.||
1625804|NCT02211131|2986200|Other||Hazard Ratio (HR)|0.75||||0.07|2-Sided|80.0|0.58|0.96||Unstratified log-rank test|Log Rank||Unstratified Hazard Ratio (T-VEC + Surgery / Surgery)||
1625805|NCT02210780|2986205|Superiority||LS Mean Difference|-8.3|Standard Error of the Mean|0.99|<|0.0001|2-Sided|90.0|-9.9|-6.6|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using the ANCOVA model which included treatment, randomization strata, and baseline value as covariates.|
1625806|NCT02210780|2986206|Superiority||LS Mean Difference|-2.4|Standard Error of the Mean|0.39|<|0.0001|2-Sided|90.0|-3.0|-1.7|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using the ANCOVA model which includes treatment, randomization strata, and baseline values as covariates.|
1625807|NCT02210780|2986208|Superiority||LS Mean Difference|-17.8|Standard Error of the Mean|2.84|<|0.0001|2-Sided|90.0|-22.5|-13.1|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using ANCOVA model that includes treatment, randomization strata and baseline value as covariates.|
1625808|NCT02210780|2986209|Superiority||LS Mean Difference|-2.13|Standard Error of the Mean|0.354|<|0.0001|2-Sided|90.0|-2.72|-1.55|||ANCOVA||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using ANCOVA model which includes treatment, randomization strata, and baseline value as covariates.|
1625809|NCT02210780|2986210|Superiority||Percentage Difference|34.0|||<|0.0001|2-Sided|90.0|23.38|44.66|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate [IGA=3] vs. severe [IGA=4] AD).|
1625810|NCT02210780|2986211|Superiority||Percentage Difference|40.2|||<|0.0001|2-Sided|90.0|29.4|51.01|||Cochran-Mantel-Haenszel||Dupilumab 300 mg qw vs. Placebo qw|Analysis was performed using Cochran-Mantel-Haenszel test stratified by randomization strata (moderate [IGA=3] vs. severe [IGA=4] AD).|
1626124|NCT02207478|2986489|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||X-ray time for finding lesions|
1625812|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.356|||||2-Sided|95.0|-0.0049|0.7179|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Total GCSI-DD at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625813|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.479|||||2-Sided|95.0|-0.0386|0.9966|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Bloating Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625814|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.548|||||2-Sided|95.0|0.1333|0.9628|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Fullness/Early Satiety Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625815|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.068|||||2-Sided|95.0|-0.2366|0.3723|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Nausea/Vomiting Subscale at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625816|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.384|||||2-Sided|95.0|-0.0323|0.7997|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Overall severity of your GP symptoms at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625817|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.314|||||2-Sided|95.0|-0.2013|0.8292|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Upper abdominal discomfort at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625818|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.196|||||2-Sided|95.0|-0.2746|0.6671|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Upper abdominal pain at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625819|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.536|||||2-Sided|95.0|0.0967|0.9745|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Loss of appetite at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625820|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.461|||||2-Sided|95.0|-0.0519|0.9748|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Stomach fullness at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625821|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.475|||||2-Sided|95.0|-0.0483|0.9978|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Stomach visibly larger at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625822|NCT02210000|2986258|Superiority||Mean Difference (Net)|-0.038|||||2-Sided|95.0|-0.3242|0.2492|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Vomiting at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625823|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.05|||||2-Sided|95.0|-0.3386|0.4395|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Retching at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625824|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.497|||||2-Sided|95.0|0.0396|0.955|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Not able to finish meal at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625825|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.489|||||2-Sided|95.0|-0.0592|1.0374|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Bloating at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625826|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.749|||||2-Sided|95.0|0.2275|1.2705|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Feeling full after meals at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625827|NCT02210000|2986258|Superiority||Mean Difference (Net)|0.21|||||2-Sided|95.0|-0.2353|0.6553|||||A negative difference indicated greater improvement in the Camicinal group compared to Placebo.|Nausea at Week 12. The least square means were the adjusted means which had been estimated with a mixed model using Baseline weekly average value, diabetes type, treatment, week and the interaction between treatment and week as fixed effects, participants as random effect and week as repeated effect.|
1625828|NCT02210000|2986259|Superiority||Median Difference (Net)|-0.212||||0.017|2-Sided|95.0|-0.3716|-0.0448||Posterior probability of the treatment difference in response rate at Week 12 being greater than 0%.|Bayesian method||||
1625829|NCT02209597|2986276|Superiority||||||<|0.05|||||||ANOVA||||
1625830|NCT02209272|2986310|Superiority|||||||0.57|||||||t-test, 2 sided||||
1625831|NCT02209272|2986311|Superiority|||||||0.21|||||||t-test, 2 sided||||
1625832|NCT02209272|2986312|Superiority|||||||0.82|||||||t-test, 2 sided||||
1625833|NCT02209181|2986316|Superiority or Other||Least Squares Mean Difference|-0.3|Standard Error of the Mean|0.21||0.148|2-Sided|95.0|-0.7|0.1||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625834|NCT02209181|2986316|Superiority or Other||Least Squares Mean Difference|-1.1|Standard Error of the Mean|0.21|<|0.001|2-Sided|95.0|-1.6|-0.7||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625835|NCT02209181|2986316|Superiority or Other||Least Squares Mean Difference|1.2|Standard Error of the Mean|0.21|<|0.001|2-Sided|95.0|0.8|1.6||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625836|NCT02209181|2986316|Superiority or Other||Least Squares Mean Difference|0.4|Standard Error of the Mean|0.21|<|0.077|2-Sided|95.0|0.0|0.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625837|NCT02209181|2986316|Superiority or Other||Least Squares Mean Difference|1.5|Standard Error of the Mean|0.21|<|0.001|2-Sided|95.0|1.1|1.9||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625838|NCT02209181|2986317|Superiority or Other|||||||0.006||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.|
1625839|NCT02209181|2986317|Superiority or Other|||||||0.196||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.|
1625840|NCT02209181|2986317|Superiority or Other||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.|
1625841|NCT02209181|2986317|Superiority or Other||||||<|0.779||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.|
1625842|NCT02209181|2986317|Superiority or Other||||||<|0.042||||||The significance threshold level was 0.05 (two-sided). P-Value is from Log-rank test comparing survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.|
1625843|NCT02209181|2986318|Superiority or Other||Least Squares Mean Difference|2.76|Standard Error of the Mean|0.7|<|0.001|2-Sided|95.0|1.38|4.15||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625844|NCT02209181|2986318|Superiority or Other||Least Squares Mean Difference|0.13|Standard Error of the Mean|0.69|<|0.851|2-Sided|95.0|-1.24|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625845|NCT02209181|2986318|Superiority or Other||Least Squares Mean Difference|2.52|Standard Error of the Mean|0.7|<|0.001|2-Sided|95.0|1.13|3.9||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625846|NCT02209181|2986318|Superiority or Other||Least Squares Mean Difference|-0.11|Standard Error of the Mean|0.69|<|0.869|2-Sided|95.0|-1.48|1.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625847|NCT02209181|2986318|Superiority or Other||Least Squares Mean Difference|-0.25|Standard Error of the Mean|0.7|<|0.726|2-Sided|95.0|-1.62|1.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625848|NCT02209181|2986319|Superiority or Other||Least Squares Mean Difference|2.73|Standard Error of the Mean|0.63|<|0.001|2-Sided|95.0|1.49|3.98||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625849|NCT02209181|2986319|Superiority or Other||Least Squares Mean Difference|-0.16|Standard Error of the Mean|0.63|<|0.799|2-Sided|95.0|-1.39|1.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625850|NCT02209181|2986319|Superiority or Other||Least Squares Mean Difference|2.88|Standard Error of the Mean|0.63|<|0.001|2-Sided|95.0|1.63|4.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625851|NCT02209181|2986319|Superiority or Other||Least Squares Mean Difference|-0.02|Standard Error of the Mean|0.63|<|0.978|2-Sided|95.0|-1.25|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625852|NCT02209181|2986319|Superiority or Other||Least Squares Mean Difference|0.14|Standard Error of the Mean|0.63|<|0.821|2-Sided|95.0|-1.1|1.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625853|NCT02209181|2986320|Superiority or Other||Least Squares Mean Difference|2.59|Standard Error of the Mean|0.65|<|0.001|2-Sided|95.0|1.31|3.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625854|NCT02209181|2986320|Superiority or Other||Least Squares Mean Difference|-0.04|Standard Error of the Mean|0.64|<|0.952|2-Sided|95.0|-1.3|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625855|NCT02209181|2986320|Superiority or Other||Least Squares Mean Difference|2.82|Standard Error of the Mean|0.65|<|0.001|2-Sided|95.0|1.55|4.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625856|NCT02209181|2986320|Superiority or Other||Least Squares Mean Difference|0.19|Standard Error of the Mean|0.64|<|0.763|2-Sided|95.0|-1.07|1.45||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625857|NCT02209181|2986320|Superiority or Other||Least Squares Mean Difference|0.23|Standard Error of the Mean|0.64|<|0.72|2-Sided|95.0|-1.04|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625858|NCT02209181|2986321|Superiority or Other||Least Squares Mean Difference|2.62|Standard Error of the Mean|0.64|<|0.001|2-Sided|95.0|1.35|3.89||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625859|NCT02209181|2986321|Superiority or Other||Least Squares Mean Difference|0.12|Standard Error of the Mean|0.64|<|0.848|2-Sided|95.0|-1.13|1.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625860|NCT02209181|2986321|Superiority or Other||Least Squares Mean Difference|2.98|Standard Error of the Mean|0.64|<|0.001|2-Sided|95.0|1.71|4.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625861|NCT02209181|2986321|Superiority or Other||Least Squares Mean Difference|0.49|Standard Error of the Mean|0.64|<|0.448|2-Sided|95.0|-0.77|1.74||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625862|NCT02209181|2986321|Superiority or Other||Least Squares Mean Difference|0.36|Standard Error of the Mean|0.64|<|0.573|2-Sided|95.0|-0.9|1.63||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625863|NCT02209181|2986322|Superiority or Other||Least Squares Mean Difference|2.73|Standard Error of the Mean|0.65|<|0.001|2-Sided|95.0|1.45|4.0||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625864|NCT02209181|2986322|Superiority or Other||Least Squares Mean Difference|0.13|Standard Error of the Mean|0.64|<|0.834|2-Sided|95.0|-1.12|1.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625865|NCT02209181|2986322|Superiority or Other||Least Squares Mean Difference|3.12|Standard Error of the Mean|0.65|<|0.001|2-Sided|95.0|1.85|4.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626696|NCT02194933|2987777|Superiority or Other|||||||0.0599|||||||Mixed Models Analysis||||
1625866|NCT02209181|2986322|Superiority or Other||Least Squares Mean Difference|0.53|Standard Error of the Mean|0.64|<|0.409|2-Sided|95.0|-0.73|1.79||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625867|NCT02209181|2986322|Superiority or Other||Least Squares Mean Difference|0.39|Standard Error of the Mean|0.64|<|0.541|2-Sided|95.0|-0.87|1.66||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625868|NCT02209181|2986323|Superiority or Other||Least Squares Mean Difference|2.77|Standard Error of the Mean|0.65|<|0.001|2-Sided|95.0|1.49|4.05||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625869|NCT02209181|2986323|Superiority or Other||Least Squares Mean Difference|0.25|Standard Error of the Mean|0.64|<|0.698|2-Sided|95.0|-1.02|1.52||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625870|NCT02209181|2986323|Superiority or Other||Least Squares Mean Difference|3.05|Standard Error of the Mean|0.65|<|0.001|2-Sided|95.0|1.77|4.33||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625871|NCT02209181|2986323|Superiority or Other||Least Squares Mean Difference|0.52|Standard Error of the Mean|0.64|<|0.417|2-Sided|95.0|-0.74|1.79||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625872|NCT02209181|2986323|Superiority or Other||Least Squares Mean Difference|0.27|Standard Error of the Mean|0.65|<|0.674|2-Sided|95.0|-1.0|1.55||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625873|NCT02209181|2986324|Superiority or Other||Least Squares Mean Difference|2.52|Standard Error of the Mean|0.64|<|0.001|2-Sided|95.0|1.26|3.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625874|NCT02209181|2986324|Superiority or Other||Least Squares Mean Difference|-0.47|Standard Error of the Mean|0.63|<|0.459|2-Sided|95.0|-1.72|0.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625875|NCT02209181|2986324|Superiority or Other||Least Squares Mean Difference|3.21|Standard Error of the Mean|0.64|<|0.001|2-Sided|95.0|1.95|4.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625876|NCT02209181|2986324|Superiority or Other||Least Squares Mean Difference|0.22|Standard Error of the Mean|0.63|<|0.729|2-Sided|95.0|-1.03|1.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625877|NCT02209181|2986324|Superiority or Other||Least Squares Mean Difference|0.69|Standard Error of the Mean|0.64|<|0.281|2-Sided|95.0|-0.57|1.95||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625878|NCT02209181|2986325|Superiority or Other||Least Squares Mean Difference|1.96|Standard Error of the Mean|0.66||0.003|2-Sided|95.0|0.66|3.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625879|NCT02209181|2986325|Superiority or Other||Least Squares Mean Difference|-0.81|Standard Error of the Mean|0.65||0.214|2-Sided|95.0|-2.1|0.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625880|NCT02209181|2986325|Superiority or Other||Least Squares Mean Difference|3.16|Standard Error of the Mean|0.66|<|0.001|2-Sided|95.0|1.86|4.46||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625881|NCT02209181|2986325|Superiority or Other||Least Squares Mean Difference|0.39|Standard Error of the Mean|0.65|<|0.547|2-Sided|95.0|-0.89|1.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625882|NCT02209181|2986325|Superiority or Other||Least Squares Mean Difference|1.21|Standard Error of the Mean|0.66|<|0.067|2-Sided|95.0|-0.09|2.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625883|NCT02209181|2986326|Superiority or Other||Least Squares Mean Difference|1.26|Standard Error of the Mean|0.65||0.056|2-Sided|95.0|-0.03|2.55||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625884|NCT02209181|2986326|Superiority or Other||Least Squares Mean Difference|-1.5|Standard Error of the Mean|0.65||0.021|2-Sided|95.0|-2.78|-0.23||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626125|NCT02207478|2986489|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Duration time for finding lesions|
1625885|NCT02209181|2986326|Superiority or Other||Least Squares Mean Difference|3.36|Standard Error of the Mean|0.65|<|0.001|2-Sided|95.0|2.07|4.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625886|NCT02209181|2986326|Superiority or Other||Least Squares Mean Difference|0.6|Standard Error of the Mean|0.65|<|0.355|2-Sided|95.0|-0.68|1.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625887|NCT02209181|2986326|Superiority or Other||Least Squares Mean Difference|2.1|Standard Error of the Mean|0.65|<|0.001|2-Sided|95.0|0.82|3.39||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625888|NCT02209181|2986327|Superiority or Other||Least Squares Mean Difference|0.77|Standard Error of the Mean|0.65||0.235|2-Sided|95.0|-0.5|2.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625889|NCT02209181|2986327|Superiority or Other||Least Squares Mean Difference|-1.95|Standard Error of the Mean|0.64||0.002|2-Sided|95.0|-3.21|-0.69||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625890|NCT02209181|2986327|Superiority or Other||Least Squares Mean Difference|3.6|Standard Error of the Mean|0.65|<|0.001|2-Sided|95.0|2.33|4.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625891|NCT02209181|2986327|Superiority or Other||Least Squares Mean Difference|0.88|Standard Error of the Mean|0.64|<|0.17|2-Sided|95.0|-0.38|2.14||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625892|NCT02209181|2986327|Superiority or Other||Least Squares Mean Difference|2.83|Standard Error of the Mean|0.64|<|0.001|2-Sided|95.0|1.56|4.1||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625893|NCT02209181|2986328|Superiority or Other||Least Squares Mean Difference|0.52|Standard Error of the Mean|0.62||0.407|2-Sided|95.0|-0.71|1.74||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625894|NCT02209181|2986328|Superiority or Other||Least Squares Mean Difference|-2.32|Standard Error of the Mean|0.61|<|0.001|2-Sided|95.0|-3.53|-1.11||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625895|NCT02209181|2986328|Superiority or Other||Least Squares Mean Difference|3.91|Standard Error of the Mean|0.62|<|0.001|2-Sided|95.0|2.69|5.14||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625896|NCT02209181|2986328|Superiority or Other||Least Squares Mean Difference|1.07|Standard Error of the Mean|0.61|<|0.081|2-Sided|95.0|-0.13|2.28||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625897|NCT02209181|2986328|Superiority or Other||Least Squares Mean Difference|3.4|Standard Error of the Mean|0.62|<|0.001|2-Sided|95.0|2.18|4.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625898|NCT02209181|2986329|Superiority or Other||Least Squares Mean Difference|0.02|Standard Error of the Mean|0.6||0.978|2-Sided|95.0|-1.16|1.19||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625899|NCT02209181|2986329|Superiority or Other||Least Squares Mean Difference|-2.48|Standard Error of the Mean|0.59|<|0.001|2-Sided|95.0|-3.64|-1.32||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625900|NCT02209181|2986329|Superiority or Other||Least Squares Mean Difference|3.82|Standard Error of the Mean|0.6|<|0.001|2-Sided|95.0|2.64|4.99||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625901|NCT02209181|2986329|Superiority or Other||Least Squares Mean Difference|1.32|Standard Error of the Mean|0.59|<|0.026|2-Sided|95.0|0.16|2.48||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625902|NCT02209181|2986329|Superiority or Other||Least Squares Mean Difference|3.8|Standard Error of the Mean|0.59|<|0.001|2-Sided|95.0|2.63|4.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625903|NCT02209181|2986330|Superiority or Other||Least Squares Mean Difference|-0.98|Standard Error of the Mean|0.54||0.074|2-Sided|95.0|-2.05|0.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625904|NCT02209181|2986330|Superiority or Other||Least Squares Mean Difference|-3.35|Standard Error of the Mean|0.54|<|0.001|2-Sided|95.0|-4.41|-2.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625905|NCT02209181|2986330|Superiority or Other||Least Squares Mean Difference|3.73|Standard Error of the Mean|0.54|<|0.001|2-Sided|95.0|2.66|4.81||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625906|NCT02209181|2986330|Superiority or Other||Least Squares Mean Difference|1.36|Standard Error of the Mean|0.54|<|0.012|2-Sided|95.0|0.3|2.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625907|NCT02209181|2986330|Superiority or Other||Least Squares Mean Difference|4.71|Standard Error of the Mean|0.54|<|0.001|2-Sided|95.0|3.64|5.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625908|NCT02209181|2986331|Superiority or Other||Least Squares Mean Difference|-1.91|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|-2.89|-0.94||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625909|NCT02209181|2986331|Superiority or Other||Least Squares Mean Difference|-3.75|Standard Error of the Mean|0.49|<|0.001|2-Sided|95.0|-4.71|-2.78||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625910|NCT02209181|2986331|Superiority or Other||Least Squares Mean Difference|2.96|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|1.98|3.93||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625911|NCT02209181|2986331|Superiority or Other||Least Squares Mean Difference|1.13|Standard Error of the Mean|0.49|<|0.023|2-Sided|95.0|0.16|2.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625912|NCT02209181|2986331|Superiority or Other||Least Squares Mean Difference|4.87|Standard Error of the Mean|0.49|<|0.001|2-Sided|95.0|3.9|5.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625913|NCT02209181|2986332|Superiority or Other||Least Squares Mean Difference|-2.08|Standard Error of the Mean|0.46|<|0.001|2-Sided|95.0|-3.0|-1.17||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625914|NCT02209181|2986332|Superiority or Other||Least Squares Mean Difference|-3.49|Standard Error of the Mean|0.46|<|0.001|2-Sided|95.0|-4.4|-2.59||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625915|NCT02209181|2986332|Superiority or Other||Least Squares Mean Difference|2.26|Standard Error of the Mean|0.46|<|0.001|2-Sided|95.0|1.34|3.17||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625916|NCT02209181|2986332|Superiority or Other||Least Squares Mean Difference|0.85|Standard Error of the Mean|0.46|<|0.067|2-Sided|95.0|-0.06|1.75||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625917|NCT02209181|2986332|Superiority or Other||Least Squares Mean Difference|4.34|Standard Error of the Mean|0.46|<|0.001|2-Sided|95.0|3.43|5.25||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625918|NCT02209181|2986333|Superiority or Other||Least Squares Mean Difference|-2.31|Standard Error of the Mean|0.43|<|0.001|2-Sided|95.0|-3.15|-1.47||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625919|NCT02209181|2986333|Superiority or Other||Least Squares Mean Difference|-2.9|Standard Error of the Mean|0.42|<|0.001|2-Sided|95.0|-3.73|-2.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625920|NCT02209181|2986333|Superiority or Other||Least Squares Mean Difference|1.47|Standard Error of the Mean|0.43|<|0.001|2-Sided|95.0|0.63|2.3||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625921|NCT02209181|2986333|Superiority or Other||Least Squares Mean Difference|0.88|Standard Error of the Mean|0.42|<|0.037|2-Sided|95.0|0.05|1.71||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625922|NCT02209181|2986333|Superiority or Other||Least Squares Mean Difference|3.78|Standard Error of the Mean|0.42|<|0.001|2-Sided|95.0|2.94|4.61||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625923|NCT02209181|2986334|Superiority or Other||Least Squares Mean Difference|-1.34|Standard Error of the Mean|0.33|<|0.001|2-Sided|95.0|-1.98|-0.7||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625924|NCT02209181|2986334|Superiority or Other||Least Squares Mean Difference|-1.48|Standard Error of the Mean|0.32|<|0.001|2-Sided|95.0|-2.11|-0.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625925|NCT02209181|2986334|Superiority or Other||Least Squares Mean Difference|0.43|Standard Error of the Mean|0.33|<|0.183|2-Sided|95.0|-0.21|1.08||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625926|NCT02209181|2986334|Superiority or Other||Least Squares Mean Difference|0.3|Standard Error of the Mean|0.32|<|0.35|2-Sided|95.0|-0.33|0.94||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625927|NCT02209181|2986334|Superiority or Other||Least Squares Mean Difference|1.78|Standard Error of the Mean|0.32|<|0.001|2-Sided|95.0|1.14|2.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625928|NCT02209181|2986335|Superiority or Other||Least Squares Mean Difference|-0.14|Standard Error of the Mean|0.16||0.376|2-Sided|95.0|-0.46|0.18||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625929|NCT02209181|2986335|Superiority or Other||Least Squares Mean Difference|-0.19|Standard Error of the Mean|0.16||0.239|2-Sided|95.0|-0.51|0.13||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625930|NCT02209181|2986335|Superiority or Other||Least Squares Mean Difference|0.11|Standard Error of the Mean|0.16||0.497|2-Sided|95.0|-0.21|0.43||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625931|NCT02209181|2986335|Superiority or Other||Least Squares Mean Difference|0.06|Standard Error of the Mean|0.16||0.687|2-Sided|95.0|-0.25|0.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625932|NCT02209181|2986335|Superiority or Other||Least Squares Mean Difference|0.25|Standard Error of the Mean|0.16||0.117|2-Sided|95.0|-0.06|0.57||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625933|NCT02209181|2986336|Superiority or Other||Least Squares Mean Difference|2.06|Standard Error of the Mean|0.55|<|0.001|2-Sided|95.0|0.97|3.16||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625934|NCT02209181|2986336|Superiority or Other||Least Squares Mean Difference|-0.12|Standard Error of the Mean|0.55|<|0.829|2-Sided|95.0|-1.2|0.96||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625935|NCT02209181|2986336|Superiority or Other||Least Squares Mean Difference|2.32|Standard Error of the Mean|0.55|<|0.001|2-Sided|95.0|1.23|3.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625936|NCT02209181|2986336|Superiority or Other||Least Squares Mean Difference|0.14|Standard Error of the Mean|0.55|<|0.798|2-Sided|95.0|-0.94|1.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625937|NCT02209181|2986336|Superiority or Other||Least Squares Mean Difference|0.26|Standard Error of the Mean|0.55|<|0.64|2-Sided|95.0|-0.83|1.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625938|NCT02209181|2986337|Superiority or Other||Least Squares Mean Difference|2.06|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|1.08|3.05||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625939|NCT02209181|2986337|Superiority or Other||Least Squares Mean Difference|-0.29|Standard Error of the Mean|0.49|<|0.557|2-Sided|95.0|-1.27|0.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625940|NCT02209181|2986337|Superiority or Other||Least Squares Mean Difference|2.5|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|1.52|3.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625941|NCT02209181|2986337|Superiority or Other||Least Squares Mean Difference|0.15|Standard Error of the Mean|0.49|<|0.767|2-Sided|95.0|-0.83|1.12||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626126|NCT02207478|2986489|Superiority or Other||||||<|0.233|||||||Wilcoxon (Mann-Whitney)|||Total X-ray time|
1625942|NCT02209181|2986337|Superiority or Other||Least Squares Mean Difference|0.44|Standard Error of the Mean|0.5|<|0.38|2-Sided|95.0|-0.54|1.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625943|NCT02209181|2986338|Superiority or Other||Least Squares Mean Difference|2.04|Standard Error of the Mean|0.51|<|0.001|2-Sided|95.0|1.03|3.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625944|NCT02209181|2986338|Superiority or Other||Least Squares Mean Difference|-0.18|Standard Error of the Mean|0.5|<|0.722|2-Sided|95.0|-1.17|0.81||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625945|NCT02209181|2986338|Superiority or Other||Least Squares Mean Difference|2.53|Standard Error of the Mean|0.51|<|0.001|2-Sided|95.0|1.53|3.54||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625946|NCT02209181|2986338|Superiority or Other||Least Squares Mean Difference|0.32|Standard Error of the Mean|0.5|<|0.531|2-Sided|95.0|-0.68|1.31||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625947|NCT02209181|2986338|Superiority or Other||Least Squares Mean Difference|0.5|Standard Error of the Mean|0.51|<|0.329|2-Sided|95.0|-0.5|1.5||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625948|NCT02209181|2986339|Superiority or Other||Least Squares Mean Difference|2.11|Standard Error of the Mean|0.51|<|0.001|2-Sided|95.0|1.11|3.12||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625949|NCT02209181|2986339|Superiority or Other||Least Squares Mean Difference|-0.02|Standard Error of the Mean|0.51|<|0.971|2-Sided|95.0|-1.02|0.98||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625950|NCT02209181|2986339|Superiority or Other||Least Squares Mean Difference|2.67|Standard Error of the Mean|0.51|<|0.001|2-Sided|95.0|1.66|3.68||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625951|NCT02209181|2986339|Superiority or Other||Least Squares Mean Difference|0.54|Standard Error of the Mean|0.51|<|0.292|2-Sided|95.0|-0.46|1.53||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625952|NCT02209181|2986339|Superiority or Other||Least Squares Mean Difference|0.55|Standard Error of the Mean|0.51|<|0.279|2-Sided|95.0|-0.45|1.56||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625953|NCT02209181|2986340|Superiority or Other||Least Squares Mean Difference|2.27|Standard Error of the Mean|0.51|<|0.001|2-Sided|95.0|1.25|3.28||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625954|NCT02209181|2986340|Superiority or Other||Least Squares Mean Difference|-0.03|Standard Error of the Mean|0.51|<|0.946|2-Sided|95.0|-1.03|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625955|NCT02209181|2986340|Superiority or Other||Least Squares Mean Difference|2.79|Standard Error of the Mean|0.51|<|0.001|2-Sided|95.0|1.78|3.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625956|NCT02209181|2986340|Superiority or Other||Least Squares Mean Difference|0.49|Standard Error of the Mean|0.51|<|0.335|2-Sided|95.0|-0.51|1.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625957|NCT02209181|2986340|Superiority or Other||Least Squares Mean Difference|0.52|Standard Error of the Mean|0.51|<|0.306|2-Sided|95.0|-0.48|1.53||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625958|NCT02209181|2986341|Superiority or Other||Least Squares Mean Difference|2.22|Standard Error of the Mean|0.52|<|0.001|2-Sided|95.0|1.21|3.24||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625959|NCT02209181|2986341|Superiority or Other||Least Squares Mean Difference|0.04|Standard Error of the Mean|0.51|<|0.942|2-Sided|95.0|-0.97|1.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625960|NCT02209181|2986341|Superiority or Other||Least Squares Mean Difference|2.72|Standard Error of the Mean|0.52|<|0.001|2-Sided|95.0|1.7|3.73||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626127|NCT02207478|2986489|Superiority or Other||||||<|0.843|||||||Wilcoxon (Mann-Whitney)|||Total procedure time|
1625961|NCT02209181|2986341|Superiority or Other||Least Squares Mean Difference|0.53|Standard Error of the Mean|0.51|<|0.299|2-Sided|95.0|-0.47|1.54||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625962|NCT02209181|2986341|Superiority or Other||Least Squares Mean Difference|0.49|Standard Error of the Mean|0.51|<|0.338|2-Sided|95.0|-0.52|1.51||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625963|NCT02209181|2986342|Superiority or Other||Least Squares Mean Difference|2.01|Standard Error of the Mean|0.51|<|0.001|2-Sided|95.0|1.01|3.02||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625964|NCT02209181|2986342|Superiority or Other||Least Squares Mean Difference|-0.48|Standard Error of the Mean|0.51|<|0.345|2-Sided|95.0|-1.47|0.52||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625965|NCT02209181|2986342|Superiority or Other||Least Squares Mean Difference|2.85|Standard Error of the Mean|0.51|<|0.001|2-Sided|95.0|1.85|3.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625966|NCT02209181|2986342|Superiority or Other||Least Squares Mean Difference|0.36|Standard Error of the Mean|0.51|<|0.479|2-Sided|95.0|-0.64|1.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625967|NCT02209181|2986342|Superiority or Other||Least Squares Mean Difference|0.84|Standard Error of the Mean|0.51|<|0.102|2-Sided|95.0|-0.17|1.84||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625968|NCT02209181|2986343|Superiority or Other||Least Squares Mean Difference|1.55|Standard Error of the Mean|0.53||0.004|2-Sided|95.0|0.51|2.6||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625969|NCT02209181|2986343|Superiority or Other||Least Squares Mean Difference|-0.72|Standard Error of the Mean|0.52||0.172|2-Sided|95.0|-1.75|0.31||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625970|NCT02209181|2986343|Superiority or Other||Least Squares Mean Difference|2.8|Standard Error of the Mean|0.53|<|0.001|2-Sided|95.0|1.76|3.85||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625971|NCT02209181|2986343|Superiority or Other||Least Squares Mean Difference|0.53|Standard Error of the Mean|0.52|<|0.31|2-Sided|95.0|-0.5|1.56||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625972|NCT02209181|2986343|Superiority or Other||Least Squares Mean Difference|1.25|Standard Error of the Mean|0.53|<|0.018|2-Sided|95.0|0.21|2.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625973|NCT02209181|2986344|Superiority or Other||Least Squares Mean Difference|1.03|Standard Error of the Mean|0.53||0.052|2-Sided|95.0|-0.01|2.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625974|NCT02209181|2986344|Superiority or Other||Least Squares Mean Difference|-1.34|Standard Error of the Mean|0.52||0.011|2-Sided|95.0|-2.37|-0.32||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625975|NCT02209181|2986344|Superiority or Other||Least Squares Mean Difference|2.95|Standard Error of the Mean|0.53|<|0.001|2-Sided|95.0|1.91|3.99||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625976|NCT02209181|2986344|Superiority or Other||Least Squares Mean Difference|0.58|Standard Error of the Mean|0.52|<|0.271|2-Sided|95.0|-0.45|1.61||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625977|NCT02209181|2986344|Superiority or Other||Least Squares Mean Difference|1.92|Standard Error of the Mean|0.53|<|0.001|2-Sided|95.0|0.88|2.96||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625978|NCT02209181|2986345|Superiority or Other||Least Squares Mean Difference|0.59|Standard Error of the Mean|0.52||0.262|2-Sided|95.0|-0.44|1.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625979|NCT02209181|2986345|Superiority or Other||Least Squares Mean Difference|-1.73|Standard Error of the Mean|0.52|<|0.001|2-Sided|95.0|-2.75|-0.71||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626128|NCT02207478|2986490|Superiority or Other|||||||0.019|||||||Cochran-Mantel-Haenszel||||
1625980|NCT02209181|2986345|Superiority or Other||Least Squares Mean Difference|3.13|Standard Error of the Mean|0.52|<|0.001|2-Sided|95.0|2.1|4.16||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625981|NCT02209181|2986345|Superiority or Other||Least Squares Mean Difference|0.81|Standard Error of the Mean|0.52|<|0.118|2-Sided|95.0|-0.21|1.83||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625982|NCT02209181|2986345|Superiority or Other||Least Squares Mean Difference|2.55|Standard Error of the Mean|0.52|<|0.001|2-Sided|95.0|1.52|3.57||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625983|NCT02209181|2986346|Superiority or Other||Least Squares Mean Difference|0.39|Standard Error of the Mean|0.51||0.44|2-Sided|95.0|-0.61|1.4||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625984|NCT02209181|2986346|Superiority or Other||Least Squares Mean Difference|-1.99|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|-2.98|-1.0||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625985|NCT02209181|2986346|Superiority or Other||Least Squares Mean Difference|3.27|Standard Error of the Mean|0.51|<|0.001|2-Sided|95.0|2.27|4.27||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625986|NCT02209181|2986346|Superiority or Other||Least Squares Mean Difference|0.89|Standard Error of the Mean|0.5|<|0.079|2-Sided|95.0|-0.1|1.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625987|NCT02209181|2986346|Superiority or Other||Least Squares Mean Difference|2.87|Standard Error of the Mean|0.51|<|0.001|2-Sided|95.0|1.87|3.87||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625988|NCT02209181|2986347|Superiority or Other||Least Squares Mean Difference|0.02|Standard Error of the Mean|0.48||0.973|2-Sided|95.0|-0.93|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625989|NCT02209181|2986347|Superiority or Other||Least Squares Mean Difference|-2.15|Standard Error of the Mean|0.48|<|0.001|2-Sided|95.0|-3.09|-1.21||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625990|NCT02209181|2986347|Superiority or Other||Least Squares Mean Difference|3.14|Standard Error of the Mean|0.48|<|0.001|2-Sided|95.0|2.19|4.09||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625991|NCT02209181|2986347|Superiority or Other||Least Squares Mean Difference|0.98|Standard Error of the Mean|0.48|<|0.041|2-Sided|95.0|0.04|1.92||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625992|NCT02209181|2986347|Superiority or Other||Least Squares Mean Difference|3.13|Standard Error of the Mean|0.48|<|0.001|2-Sided|95.0|2.18|4.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625993|NCT02209181|2986348|Superiority or Other||Least Squares Mean Difference|-0.72|Standard Error of the Mean|0.44||0.104|2-Sided|95.0|-1.59|0.15||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625994|NCT02209181|2986348|Superiority or Other||Least Squares Mean Difference|-2.77|Standard Error of the Mean|0.44|<|0.001|2-Sided|95.0|-3.63|-1.91||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625995|NCT02209181|2986348|Superiority or Other||Least Squares Mean Difference|3.06|Standard Error of the Mean|0.44|<|0.001|2-Sided|95.0|2.19|3.93||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625996|NCT02209181|2986348|Superiority or Other||Least Squares Mean Difference|1.02|Standard Error of the Mean|0.44|<|0.021|2-Sided|95.0|0.16|1.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625997|NCT02209181|2986348|Superiority or Other||Least Squares Mean Difference|3.78|Standard Error of the Mean|0.44|<|0.001|2-Sided|95.0|2.92|4.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1625998|NCT02209181|2986349|Superiority or Other||Least Squares Mean Difference|-1.51|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-2.29|-0.73||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626697|NCT02194933|2987777|Superiority or Other|||||||0.2301|||||||Mixed Models Analysis||||
1625999|NCT02209181|2986349|Superiority or Other||Least Squares Mean Difference|-3.12|Standard Error of the Mean|0.39|<|0.001|2-Sided|95.0|-3.9|-2.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626000|NCT02209181|2986349|Superiority or Other||Least Squares Mean Difference|2.48|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|1.7|3.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626001|NCT02209181|2986349|Superiority or Other||Least Squares Mean Difference|0.86|Standard Error of the Mean|0.39|<|0.028|2-Sided|95.0|0.09|1.64||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626002|NCT02209181|2986349|Superiority or Other||Least Squares Mean Difference|3.99|Standard Error of the Mean|0.39|<|0.001|2-Sided|95.0|3.21|4.77||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626003|NCT02209181|2986350|Superiority or Other||Least Squares Mean Difference|-1.79|Standard Error of the Mean|0.37|<|0.001|2-Sided|95.0|-2.52|-1.07||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626004|NCT02209181|2986350|Superiority or Other||Least Squares Mean Difference|-2.96|Standard Error of the Mean|0.36|<|0.001|2-Sided|95.0|-3.68|-2.24||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626005|NCT02209181|2986350|Superiority or Other||Least Squares Mean Difference|1.94|Standard Error of the Mean|0.37|<|0.001|2-Sided|95.0|1.21|2.67||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626006|NCT02209181|2986350|Superiority or Other||Least Squares Mean Difference|0.78|Standard Error of the Mean|0.36|<|0.035|2-Sided|95.0|0.06|1.49||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626007|NCT02209181|2986350|Superiority or Other||Least Squares Mean Difference|3.73|Standard Error of the Mean|0.37|<|0.001|2-Sided|95.0|3.01|4.46||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626008|NCT02209181|2986351|Superiority or Other||Least Squares Mean Difference|-1.71|Standard Error of the Mean|0.34|<|0.001|2-Sided|95.0|-2.37|-1.04||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626009|NCT02209181|2986351|Superiority or Other||Least Squares Mean Difference|-2.3|Standard Error of the Mean|0.33|<|0.001|2-Sided|95.0|-2.96|-1.65||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626010|NCT02209181|2986351|Superiority or Other||Least Squares Mean Difference|1.23|Standard Error of the Mean|0.34|<|0.001|2-Sided|95.0|0.57|1.89||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626011|NCT02209181|2986351|Superiority or Other||Least Squares Mean Difference|0.63|Standard Error of the Mean|0.33|<|0.058|2-Sided|95.0|-0.02|1.29||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626012|NCT02209181|2986351|Superiority or Other||Least Squares Mean Difference|2.93|Standard Error of the Mean|0.33|<|0.001|2-Sided|95.0|2.28|3.59||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626013|NCT02209181|2986352|Superiority or Other||Least Squares Mean Difference|-0.88|Standard Error of the Mean|0.26|<|0.001|2-Sided|95.0|-1.4|-0.37||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626014|NCT02209181|2986352|Superiority or Other||Least Squares Mean Difference|-1.13|Standard Error of the Mean|0.26|<|0.001|2-Sided|95.0|-1.64|-0.62||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626015|NCT02209181|2986352|Superiority or Other||Least Squares Mean Difference|0.46|Standard Error of the Mean|0.26|<|0.083|2-Sided|95.0|-0.06|0.97||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626016|NCT02209181|2986352|Superiority or Other||Least Squares Mean Difference|0.21|Standard Error of the Mean|0.26|<|0.42|2-Sided|95.0|-0.3|0.72||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626017|NCT02209181|2986352|Superiority or Other||Least Squares Mean Difference|1.34|Standard Error of the Mean|0.26|<|0.001|2-Sided|95.0|0.82|1.86||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626698|NCT02194933|2987778|Superiority or Other|||||||0.8829|||||||Mixed Models Analysis||||
1626018|NCT02209181|2986353|Superiority or Other||Least Squares Mean Difference|-0.04|Standard Error of the Mean|0.15||0.794|2-Sided|95.0|-0.34|0.26||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626019|NCT02209181|2986353|Superiority or Other||Least Squares Mean Difference|-0.19|Standard Error of the Mean|0.15||0.207|2-Sided|95.0|-0.49|0.11||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626020|NCT02209181|2986353|Superiority or Other||Least Squares Mean Difference|0.08|Standard Error of the Mean|0.15||0.621|2-Sided|95.0|-0.23|0.38||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626021|NCT02209181|2986353|Superiority or Other||Least Squares Mean Difference|-0.08|Standard Error of the Mean|0.15||0.618|2-Sided|95.0|-0.38|0.22||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626022|NCT02209181|2986353|Superiority or Other||Least Squares Mean Difference|0.12|Standard Error of the Mean|0.15||0.448|2-Sided|95.0|-0.19|0.42||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626023|NCT02209181|2986354|Superiority or Other||Least Squares Mean Difference|-0.19|Standard Error of the Mean|2.531||0.941|2-Sided|95.0|-5.17|4.8||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626024|NCT02209181|2986354|Superiority or Other||Least Squares Mean Difference|-11.81|Standard Error of the Mean|2.503|<|0.001|2-Sided|95.0|-16.73|-6.88||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626025|NCT02209181|2986354|Superiority or Other||Least Squares Mean Difference|16.2|Standard Error of the Mean|2.531|<|0.001|2-Sided|95.0|11.21|21.18||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626026|NCT02209181|2986354|Superiority or Other||Least Squares Mean Difference|4.58|Standard Error of the Mean|2.503|<|0.068|2-Sided|95.0|-0.35|9.51||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626027|NCT02209181|2986354|Superiority or Other||Least Squares Mean Difference|16.38|Standard Error of the Mean|2.522|<|0.001|2-Sided|95.0|11.42|21.35||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1626028|NCT02208089|2986389|Non-Inferiority|Non-inferiority = no significant difference between rates of clinically significant visual loss between groups at the p≤0.05 level||||||0.13|||||||Chi-squared|||null hypothesis = rates of clinically significant visual loss are equal for TransPRKCXL and CXL only|
1626029|NCT02208089|2986390|Superiority|||||||0.005|||||||Chi-squared|||Null hypothesis = an equal proportion of patients in both study arms have clinically significant visual gains|
1626030|NCT02208089|2986391|Superiority|||||||0.03|||||||t-test, 2 sided|||Null hypothesis = TransPRK produced no gains in vision over and above those produced by CXL only|
1626031|NCT02207907|2986417|Superiority or Other||Adjusted Mean Difference|-0.201|||<|0.0001|2-Sided|95.0|-0.237|-0.165|||ANCOVA|From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1626032|NCT02207907|2986418|Superiority or Other||Adjusted Mean Difference|-17.491|||<|0.0001|2-Sided|95.0|-20.317|-14.664|||ANCOVA|From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.||
1626033|NCT02207829|2986419|Non-Inferiority or Equivalence|Alternate hypothesis: the difference between the trt means (umeclidinium minus tiotropium) would be > -50 milliliters (mL). If the lower CI (2.5% 1-sided significance level) of the statistical test should fall above -50 mL, then umeclidinium may be deemed statistically non-inferior to tiotropium. If the lower CI (2.5% 1-sided significance) of the statistical testing exceeded 0 then, umeclidinium may be deemed statistically superior to tiotropium.|Mean Difference (Final Values)|0.059|||<|0.001|2-Sided|95.0|0.029|0.088|||Mixed Models Analysis||||
1626034|NCT02207816|2986424|Superiority||Vaccine efficacy|-498.1||||0.124|2-Sided|95.0|-27000.0|27.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626035|NCT02207816|2986424|Superiority||Vaccine efficacy|-297.5||||0.374|2-Sided|95.0|-19000.0|60.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626036|NCT02207816|2986424|Superiority||Vaccine efficacy|-77.1||||0.3834|2-Sided|95.0|-725.0|55.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626142|NCT02207244|2986567|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).|
1626037|NCT02207816|2986424|Superiority||Vaccine efficacy|-24.3||||1|2-Sided|95.0|-526.0|73.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626038|NCT02207816|2986425|Superiority||Vaccine efficacy|-304.8||||0.2154|2-Sided|95.0|-20000.0|59.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626039|NCT02207816|2986425|Superiority||Vaccine efficacy|-98.8||||1|2-Sided|95.0|-12000.0|89.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626040|NCT02207816|2986426|Superiority||Vaccine efficacy|-406.0||||0.0213|2-Sided|95.0|-4650.0|-7.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626041|NCT02207816|2986426|Superiority||Vaccine efficacy|-98.8||||0.6869|2-Sided|95.0|-2098.0|71.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626042|NCT02207816|2986427|Superiority||Vaccine efficacy|3.1||||1|2-Sided|95.0|-7509.0|98.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group) over the entire follow-up period (from Year 0 to Year 3).|
1626043|NCT02207816|2986427|Superiority||Vaccine efficacy|-188.9||||0.6244|2-Sided|95.0|-15000.0|76.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group) over the entire follow-up period (from Year 0 to Year 3).|
1626044|NCT02207816|2986427|Superiority||Vaccine efficacy|-5.7||||1|2-Sided|95.0|-1358.0|92.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group) over the entire follow-up period (from Year 0 to Year 3).|
1626045|NCT02207816|2986427|Superiority||Vaccine efficacy|50.1||||0.6244|2-Sided|95.0|-859.0|99.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group) over the entire follow-up period (from Year 0 to Year 3).|
1626046|NCT02207816|2986430|Superiority||Vaccine efficacy|20.3||||0.1729|2-Sided|95.0|-13.5|44.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Meenjugate Comparator [6-12W] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626047|NCT02207816|2986430|Superiority||Vaccine efficacy|28.5||||0.0511|2-Sided|95.0|-2.9|50.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Meenjugate Comparator [6-12W] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626048|NCT02207816|2986430|Superiority||Vaccine efficacy|14.0||||0.334|2-Sided|95.0|-17.3|37.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626049|NCT02207816|2986430|Superiority||Vaccine efficacy|35.9||||0.0051|2-Sided|95.0|10.3|54.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626050|NCT02207816|2986431|Superiority||Vaccine efficacy|18.1||||0.2346|2-Sided|95.0|-16.9|42.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626051|NCT02207816|2986431|Superiority||Vaccine efficacy|29.2||||0.0479|2-Sided|95.0|-2.4|51.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626052|NCT02207816|2986431|Superiority||Vaccine efficacy|11.7||||0.4255|2-Sided|95.0|-20.0|35.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626053|NCT02207816|2986431|Superiority||Vaccine efficacy|35.5||||0.0053|2-Sided|95.0|10.0|54.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group), from Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|
1626054|NCT02207816|2986432|Superiority||Vaccine efficacy|13.15||||0.0056|2-Sided|95.0|4.05|21.39|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).|
1626055|NCT02207816|2986432|Superiority||Vaccine efficacy|15.55||||0.0009|2-Sided|95.0|6.72|23.54|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).|
1626056|NCT02207816|2986432|Superiority||Vaccine efficacy|19.15|||<|0.0001|2-Sided|95.0|10.81|26.71|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).|
1626057|NCT02207816|2986432|Superiority||Vaccine efficacy|23.67|||<|0.0001|2-Sided|95.0|15.93|30.71|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).|
1626058|NCT02207816|2986433|Superiority||Vaccine efficacy|34.24||||0.0122|2-Sided|95.0|8.74|52.61|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).|
1626059|NCT02207816|2986433|Superiority||Vaccine efficacy|30.99||||0.0245|2-Sided|95.0|4.67|50.04|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).|
1626060|NCT02207816|2986433|Superiority||Vaccine efficacy|10.14||||0.443|2-Sided|95.0|-18.1|31.64|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).|
1626061|NCT02207816|2986433|Superiority||Vaccine efficacy|36.69||||0.0028|2-Sided|95.0|14.6|53.07|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).|
1626062|NCT02207816|2986434|Superiority||Vaccine efficacy|33.87||||0.0387|2-Sided|95.0|2.13|55.32|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).|
1626063|NCT02207816|2986434|Superiority||Vaccine efficacy|29.03||||0.0802|2-Sided|95.0|-4.22|51.67|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).|
1626064|NCT02207816|2986434|Superiority||Vaccine efficacy|-4.52||||0.7922|2-Sided|95.0|-45.3|24.8|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).|
1626065|NCT02207816|2986434|Superiority||Vaccine efficacy|40.5||||0.0077|2-Sided|95.0|12.84|59.39|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).|
1626066|NCT02207816|2986435|Superiority||Vaccine efficacy|24.4||||0.7887|2-Sided|95.0|-148.0|78.4|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).|
1626067|NCT02207816|2986435|Superiority||Vaccine efficacy|-18.4||||0.8138|2-Sided|95.0|-245.0|57.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).|
1626068|NCT02207816|2986435|Superiority||Vaccine efficacy|-81.0||||0.2055|2-Sided|95.0|-393.0|27.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).|
1626069|NCT02207816|2986435|Superiority||Vaccine efficacy|-116.8||||0.0724|2-Sided|95.0|-476.0|10.3|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).|
1626070|NCT02207816|2986435|Superiority||Vaccine efficacy|47.6||||0.2184|2-Sided|95.0|-54.5|84.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).|
1626699|NCT02194933|2987778|Superiority or Other|||||||0.6697|||||||Mixed Models Analysis||||
1626071|NCT02207816|2986435|Superiority||Vaccine efficacy|-46.3||||0.3239|2-Sided|95.0|-249.0|36.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).|
1626072|NCT02207816|2986435|Superiority||Vaccine efficacy|39.1||||0.549|2-Sided|95.0|-140.0|86.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626073|NCT02207816|2986435|Superiority||Vaccine efficacy|44.0||||0.3809|2-Sided|95.0|-120.0|88.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626074|NCT02207816|2986435|Superiority||Vaccine efficacy|3.2||||1|2-Sided|95.0|-151.0|63.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626075|NCT02207816|2986435|Superiority||Vaccine efficacy|36.7||||0.3543|2-Sided|95.0|-78.8|79.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626076|NCT02207816|2986435|Superiority||Vaccine efficacy|-398.6||||0.0284|2-Sided|95.0|-4642.0|-3.2|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626077|NCT02207816|2986435|Superiority||Vaccine efficacy|-254.6||||0.1025|2-Sided|95.0|-3399.0|32.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent moderate anemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626078|NCT02207816|2986436|Superiority||Vaccine efficacy|100.0||||1|2-Sided|95.0|-4051.0|100.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626079|NCT02207816|2986436|Superiority||Vaccine efficacy|100.0||||0.4987|2-Sided|95.0|-3779.0|100.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent severe anemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626080|NCT02207816|2986437|Superiority||Vaccine efficacy|-6.8||||0.628|2-Sided|95.0|-42.0|19.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).|
1626081|NCT02207816|2986437|Superiority||Vaccine efficacy|-1.4||||0.9361|2-Sided|95.0|-34.7|23.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).|
1626082|NCT02207816|2986437|Superiority||Vaccine efficacy|-4.4||||0.7091|2-Sided|95.0|-34.5|18.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).|
1626083|NCT02207816|2986437|Superiority||Vaccine efficacy|9.2||||0.4023|2-Sided|95.0|-18.0|30.1|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).|
1626084|NCT02207816|2986437|Superiority||Vaccine efficacy|-2.3||||0.9112|2-Sided|95.0|-47.6|29.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).|
1626085|NCT02207816|2986437|Superiority||Vaccine efficacy|20.8||||0.1624|2-Sided|95.0|-17.5|46.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group).|
1626086|NCT02207816|2986437|Superiority||Vaccine efficacy|0.1||||1|2-Sided|95.0|-25.8|20.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626087|NCT02207816|2986437|Superiority||Vaccine efficacy|16.4||||0.077|2-Sided|95.0|-5.9|34.0|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 3 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626088|NCT02207816|2986437|Superiority||Vaccine efficacy|13.0||||0.1889|2-Sided|95.0|-10.7|31.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626143|NCT02207244|2986567|Non-Inferiority or Equivalence (legacy)|non-inferiority margin= -10%|Difference in percentage|17.7|||<|0.001|2-Sided|95.0|11.4|24.4|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).|
1626089|NCT02207816|2986437|Superiority||Vaccine efficacy|16.0||||0.0883|2-Sided|95.0|-6.6|33.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 2 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626090|NCT02207816|2986437|Superiority||Vaccine effiicacy|42.7|||<|0.0001|2-Sided|95.0|17.4|60.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626091|NCT02207816|2986437|Superiority||Vaccine efficacy|40.8|||<|0.0001|2-Sided|95.0|15.7|58.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) against prevalent parasitemia assessed at Year 1 was estimated as 1-RR, where RR is the risk ratio (proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group).|
1626092|NCT02207816|2986438|Superiority||Vaccine efficacy|30.8||||0.4121|2-Sided|95.0|-67.6|72.5|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group) over the entire follow-up period (from Year 0 to Year 3).|
1626093|NCT02207816|2986438|Superiority||Vaccine efficacy|31.2||||0.4112|2-Sided|95.0|-66.5|72.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group) over the entire follow-up period (from Year 0 to Year 3).|
1626094|NCT02207816|2986438|Superiority||Vaccine efficacy|35.0||||0.3828|2-Sided|95.0|-69.3|76.6|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group) over the entire follow-up period (from Year 0 to Year 3).|
1626095|NCT02207816|2986438|Superiority||Vaccine efficacy|46.2||||0.1853|2-Sided|95.0|-45.0|81.8|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group) over the entire follow-up period (from Year 0 to Year 3).|
1626096|NCT02207816|2986439|Superiority||Vaccine efficacy|25.4||||0.5307|2-Sided|95.0|-84.1|70.7|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group) over the entire follow-up period (from Year 0 to Year 3).|
1626097|NCT02207816|2986439|Superiority||Vaccine efficacy|25.9||||0.5299|2-Sided|95.0|-82.9|70.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [6-12W] Group over the proportion in Menjugate Comparator [6-12W] Group) over the entire follow-up period (from Year 0 to Year 3).|
1626098|NCT02207816|2986439|Superiority||Vaccine efficacy|16.9||||0.6897|2-Sided|95.0|-96.9|65.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 Comparator [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group) over the entire follow-up period (from Year 0 to Year 3).|
1626099|NCT02207816|2986439|Superiority||Vaccine efficacy|50.1||||0.1302|2-Sided|95.0|-32.2|82.9|||Two-sided Fisher Exact test|||Vaccine efficacy (VE) was estimated as 1-the risk ratio (RR; proportion of subjects reporting events in the GSK257049 [5-17M] Group over the proportion in VeroRab Comparator [5-17M] Group) over the entire follow-up period (from Year 0 to Year 3).|
1626100|NCT02207816|2986440|Superiority||Vaccine efficacy|5.32||||0.4189|2-Sided|95.0|-8.12|17.09|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).|
1626101|NCT02207816|2986440|Superiority||Vaccine efficacy|0.62||||0.9278|2-Sided|95.0|-13.7|13.13|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).|
1626102|NCT02207816|2986440|Superiority||Vaccine efficacy|-8.1||||0.2634|2-Sided|95.0|-23.9|5.7|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].||Vaccine efficacy (VE)/incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).|
1626103|NCT02207816|2986440|Superiority||Vaccine efficacy|-5.26||||0.4434|2-Sided|95.0|-20.0|7.69|||Negative binomial regression|Mixed model with over-dispersion parameter estimated from the random effect [Lievens, 2011].||Vaccine efficacy (VE)/ incidence comparison against all episodes of clinical malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).|
1626104|NCT02207816|2986441|Superiority||Vaccine efficacy|37.57||||0.2704|2-Sided|95.0|-44.4|73.01|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).|
1626105|NCT02207816|2986441|Superiority||Vaccine efficacy|32.08||||0.3504|2-Sided|95.0|-53.1|69.87|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).|
1626593|NCT02197130|2987372|Superiority or Other||Mean Difference (Net)|-0.35|Standard Error of the Mean|1.118||0.7549|2-Sided|90.0|-2.2|1.5|||MMRM||||
1626106|NCT02207816|2986441|Superiority||Vaccine efficacy|23.33||||0.5035|2-Sided|95.0|-67.1|64.82|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).|
1626107|NCT02207816|2986441|Superiority||Vaccine efficacy|53.68||||0.093|2-Sided|95.0|-13.7|81.13|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).|
1626108|NCT02207816|2986442|Superiority||Vaccine efficacy|44.2||||0.3523|2-Sided|95.0|-90.9|83.69|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).|
1626109|NCT02207816|2986442|Superiority||Vaccine efficacy|30.58||||0.5333|2-Sided|95.0|-119.0|78.0|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [6-12W] Group over the total number of events/follow-up time in the Menjugate Comparator [6-12W] Group).|
1626110|NCT02207816|2986442|Superiority||Vaccine efficacy|-9.57||||0.8972|2-Sided|95.0|-339.0|72.64|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 Comparator [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).|
1626111|NCT02207816|2986442|Superiority||Vaccine efficacy|74.38||||0.2235|2-Sided|95.0|-130.0|97.14|||Negative binomial regression|Mixed model without random effect [Lievens, 2011].||Vaccine efficacy (VE)/ incidence comparison against all episodes of severe malaria were estimated as 1-incidence ratio (IR; total number of events/follow-up time in the GSK257049 [5-17M] Group over the total number of events/follow-up time in the VeroRab Comparator [5-17M] Group).|
1626112|NCT02207725|2986446|Superiority||Hodges-Lehman estimate of shift|999.33|||<|0.0001|2-Sided|95.0|819.5|1200.53|||2-sided test exact Wilcoxon rank-sum tes||||
1626113|NCT02207725|2986446|Superiority||Hodges-Lehman estimate of shift|1227.35|||<|0.0001|2-Sided|95.0|984.01|1456.38|||2-sided test exact Wilcoxon rank-sum tes||||
1626114|NCT02207725|2986447|Superiority||Hodges-Lehman estimate of shift|-3.02||||0.0002|2-Sided|95.0|-5.66|-1.25|||2-sided test exact Wilcoxon rank-sum tes||||
1626115|NCT02207725|2986447|Superiority||Hodges-Lehman estimate of shift|-7.09|||<|0.0001|2-Sided|95.0|-8.86|-5.42|||2-sided test exact Wilcoxon rank-sum tes||||
1626116|NCT02207725|2986449|Superiority||Hodges-Lehman estimate of shift|-77.14|||<|0.0001|2-Sided|95.0|-79.98|-74.04|||2-sided test exact Wilcoxon rank-sum tes||||
1626117|NCT02207725|2986450|Superiority||Hodges-Lehman estimate of shift|-59.5|||<|0.0001|2-Sided|95.0|-64.1|-55.17|||2-sided test exact Wilcoxon rank-sum tes||||
1626118|NCT02207725|2986450|Superiority||Hodges-Lehman estimate of shift|-74.55|||<|0.0001|2-Sided|95.0|-78.39|-66.28|||2-sided test exact Wilcoxon rank-sum tes||||
1626119|NCT02207634|2986451|Other||Treatment Difference|0.0727|Standard Error of the Mean|0.0382|||2-Sided|95.0|-0.0022|0.1477||||||A repeated measures mixed-effect linear model was used to estimate treatment difference ( placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline RTI median 5-choice reaction time Z score, treatment group, visit, and treatment by visit interaction.|
1626120|NCT02207634|2986452|Other||Treatment Difference|0.0226|Standard Error of the Mean|0.033|||2-Sided|95.0|-0.0422|0.0873||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline PAL total errors adjusted Z score, treatment group, visit, and treatment by visit interaction.|
1626121|NCT02207634|2986453|Other||Treatment Difference|0.0333|Standard Error of the Mean|0.0363|||2-Sided|95.0|-0.0378|0.1045||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening LDL-C and geographical region), age, education level, baseline SWM between-errors Z score, treatment group, visit, and treatment by visit interaction.|
1626122|NCT02207634|2986454|Non-Inferiority|The non-inferiority margin was 0.19, calculated as 20% of the observed common standard deviation, which was estimated from observations in the placebo group by a repeated measured mixed-effect linear model with visit as a covariate. If the upper bound of the 95% CI for the difference between the placebo and evolocumab group in mean change from baseline for Z score averaged across the visits was less than the non-inferiority margin non-inferiority criteria were met.|Treatment Difference|0.0072|Standard Error of the Mean|0.0375|||2-Sided|95.0|-0.0664|0.0808||||||A repeated measures mixed-effect linear model was used to estimate treatment difference (placebo - evolocumab) in change from baseline and associated 95% confidence intervals (CI). The model included stratification factors for Study 20110118 (final screening low-density lipoprotein cholesterol [LDL-C] and geographical region), age, education level, baseline SWM strategy index Z score, treatment group, visit, and treatment by visit interaction.|
1626123|NCT02207491|2986488|Non-Inferiority|Clinical noninferiority was to be concluded if the upper limit of the 95% CIs around the difference (AR-13324 - timolol) was within 1.5 mmHg at all time points and was within 1.0 mmHg at a majority of the time points.|||||<|0.0001||||||Calculated p-value|ANCOVA|Statistical analysis applies at all 3 timepoints on Day 15, Day 43, and Day 90||Assuming zero difference between AR-13324 and timolol, a 2-tailed alpha of 0.05 at each of 9 time points, a common SD of 3.0 mmHg, and a correlation between time points of 0.60 or less, 170 PP subjects per arm were necessary to have 90% power to show clinical noninferiority of AR-13324 to timolol in mean IOP.|
1626129|NCT02207413|2986514|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/Influsplit Tetra_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.17|||||2-Sided|95.0|0.99|1.38|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate|
1626130|NCT02207413|2986514|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/Influsplit Tetra_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.07|||||2-Sided|95.0|0.91|1.27||||||The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.|
1626131|NCT02207413|2986514|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/Influsplit Tetra_IP) is ≤ 1.5|Adjusted GMT Ratio|1.18|||||2-Sided|95.0|1.0|1.39|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.|
1626132|NCT02207413|2986514|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/Influsplit Tetra_IP) is ≤ 1.5.|Adjusted GMT ratio|1.07|||||2-Sided|95.0|0.9|1.28||||||The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.|
1626133|NCT02207413|2986515|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/ Influsplit Tetra_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.04|||||2-Sided|95.0|0.9|1.21|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.|
1626134|NCT02207413|2986515|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/ Influsplit Tetra_IP) is ≤ 1.5|Adjusted GMT Ratio|1.03|||||2-Sided|95.0|0.91|1.16|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.|
1626135|NCT02207413|2986515|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Influsplit Tetra_LP/ Influsplit Tetra_IP) is ≤ 1.5.|Adjusted GMT Ratio|1.05|||||2-Sided|95.0|0.94|1.18|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.|
1626136|NCT02207413|2986515|Non-Inferiority or Equivalence|Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (D-QIV_LP/ D-QIV_IP) is ≤ 1.5.|Adjusted GMT Ratio|0.97|||||2-Sided|95.0|0.85|1.11|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).|The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra_LP/ Influsplit Tetra_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.|
1626137|NCT02207400|2986539|Superiority or Other||Adjusted mean difference|-0.652|||<|0.0001|2-Sided|95.0|-0.738|-0.566|||ANCOVA||Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.||
1626138|NCT02207400|2986540|Superiority or Other||Adjusted Mean Difference|-11.612|||<|0.0001|2-Sided|95.0|-13.191|-10.033|||ANCOVA||Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.||
1626139|NCT02207244|2986564|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).|
1626140|NCT02207244|2986565|Superiority or Other (legacy)||||||<|0.001|||||||ANOVA|||p value is based on ANOVA model stratified by investigator site (pooled).|
1626141|NCT02207244|2986566|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).|
1626700|NCT02194933|2987779|Superiority or Other|||||||0.8318|||||||Mixed Models Analysis||||
1626145|NCT02207244|2986568|Non-Inferiority or Equivalence (legacy)|non-inferiority margin= -10.0%|Difference in Percentage|23.3|||<|0.001|2-Sided|95.0|16.0|30.4|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).|
1626146|NCT02207244|2986569|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).|
1626147|NCT02207244|2986569|Non-Inferiority or Equivalence (legacy)|non-inferiority margin= -10.0%|Difference in Percentage|16.4|||<|0.001|2-Sided|95.0|10.0|23.2|||MH Z-test|||p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).|
1626148|NCT02207244|2986570|Superiority or Other (legacy)||||||<|0.001|||||||ANOVA|||p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).|
1626149|NCT02207244|2986571|Superiority or Other (legacy)||||||<|0.001|||||||Log Rank|||p value is based on the log-rank test stratified by investigator site (pooled).|
1626150|NCT02207244|2986572|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test||||
1626151|NCT02207244|2986573|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test||||
1626152|NCT02207244|2986574|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test||||
1626153|NCT02207244|2986575|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test||||
1626154|NCT02207244|2986576|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test||||
1626155|NCT02207231|2986577|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).|
1626156|NCT02207231|2986578|Superiority or Other (legacy)||||||<|0.001|||||||ANOVA|||p value is based on ANOVA model stratified by investigator site (pooled).|
1626157|NCT02207231|2986579|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).|
1626158|NCT02207231|2986580|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).|
1626159|NCT02207231|2986580|Non-Inferiority or Equivalence (legacy)|non-inferiority margin= 10%|Difference in percentage|18.0|||<|0.001|2-Sided|95.0|12.4|23.8|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).|
1626160|NCT02207231|2986581|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).|
1626161|NCT02207231|2986581|Non-Inferiority or Equivalence (legacy)|non-inferiority margin= 10.0%|Difference in Percentage|24.1|||<|0.001|2-Sided|95.0|17.0|31.0|||MH Z-test|||p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).|
1626162|NCT02207231|2986582|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).|
1626163|NCT02207231|2986582|Non-Inferiority or Equivalence (legacy)|non-inferiority margin= 10.0%|Difference in Percentage|19.3|||<|0.001|2-Sided|95.0|12.9|25.7|||MH Z-test|||p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).|
1626164|NCT02207231|2986583|Superiority or Other (legacy)||||||<|0.001|||||||ANOVA|||p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).|
1626165|NCT02207231|2986584|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48|
1626166|NCT02207231|2986584|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24|
1626167|NCT02207231|2986585|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48|
1626168|NCT02207231|2986585|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24|
1626169|NCT02207231|2986586|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 48|
1626170|NCT02207231|2986586|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||Week 24|
1626171|NCT02207231|2986587|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test||||
1626172|NCT02207231|2986588|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test||||
1626173|NCT02206607|2986608|Superiority or Other||Adjusted Geometric Mean Ratio MR3/IR|31.69|||||2-Sided|90.0|28.86|34.81|||||||
1626174|NCT02206607|2986608|Superiority or Other||Adjusted Geometric Mean Ratio MR2/IR|24.96|||||2-Sided|90.0|22.73|27.4|||||||
1626175|NCT02206607|2986608|Superiority or Other||Adjusted Geometric Mean Ratio MR1/IR|31.06|||||2-Sided|90.0|28.28|34.1|||||||
1626176|NCT02206607|2986614|Superiority or Other||Adjusted Geometric Mean Ratio MR3/IR|36.94|||||2-Sided|90.0|34.09|40.02|||||||
1626177|NCT02206607|2986614|Superiority or Other||Adjusted Geometric Mean Ratio MR2/IR|26.38|||||2-Sided|90.0|24.36|28.57|||||||
1626178|NCT02206607|2986614|Superiority or Other||Adjusted Geometric Mean Ratio MR1/IR|25.21|||||2-Sided|90.0|23.28|27.31|||||||
1626179|NCT02206607|2986615|Superiority or Other||Least Square Mean|20.38|Standard Error of the Mean|3.291||1|2-Sided|80.0|16.13|24.62||1-sided p-value|Mixed Models Analysis||||
1626180|NCT02206607|2986615|Superiority or Other||Least Square Mean|16.31|Standard Error of the Mean|3.399||1|2-Sided|80.0|11.93|20.7||1-sided p-value|Mixed Models Analysis|Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.|||
1626181|NCT02206607|2986615|Superiority or Other||Least Square Mean|15.72|Standard Error of the Mean|3.357||1|2-Sided|80.0|11.39|20.06||1-sided p-value|Mixed Models Analysis|Treatment, period, sequence as fixed effects and subjects-within-sequence as random effects.|||
1626182|NCT02206607|2986616|Superiority or Other||Adjusted Geometric Mean Ratio MR3/IR|32.04|||||2-Sided|90.0|28.93|35.49|||||||
1626183|NCT02206607|2986616|Superiority or Other||Adjusted Geometric Mean Ratio MR2/IR|25.56|||||2-Sided|90.0|23.11|28.27|||||||
1626184|NCT02206607|2986616|Superiority or Other||Adjusted Geometric Mean Ratio MR1/IR|31.27|||||2-Sided|90.0|28.09|34.8|||||||
1626185|NCT02205814|2986623|Superiority or Other||||||<|0.05||||||Fourhundred evaluable patients were supposed to provide approximately 80% power in rejecting the null hypothesis of equality between any dose of fasitibant and placebo based on previous results and an overall significance level of 5% (two-sided).|mixed linear model for repeated measures|||All secondary efficacy variables were analysed on the ITT population only. Multiplicity was adjusted using the Hochberg procedure. The continuous secondary efficacy variables were analysed over time and were treated in the same way as the primary efficacy variable with respective output.|
1626186|NCT02205814|2986624|Superiority or Other||||||<|0.05||||||Fourhundred evaluable patients were supposed to provide approximately 80% power in rejecting the null hypothesis of equality between any dose of fasitibant and placebo based on previous results and an overall significance level of 5% (two-sided).|mixed linear model for repeated measures||||
1626187|NCT02204124|2986726|Superiority|||||||0.219|||||||Chi-squared|||Statistical analysis #7 is for blood product transfusion (anemia).|
1626188|NCT02204124|2986726|Superiority|||||||0.401|||||||Chi-squared|||Statistical analysis #6 is for anastomotic leakage.|
1626189|NCT02204124|2986726|Superiority|||||||0.219|||||||Chi-squared|||Statistical analysis #5 is for intraabdominal abscess.|
1626190|NCT02204124|2986726|Superiority|||||||0.401|||||||Chi-squared|||Statistical analysis #4 is for pancreatic fistula.|
1626191|NCT02204124|2986726|Superiority|||||||0.975|||||||Chi-squared|||Statistical analysis #3 is for gastroparesis.|
1626192|NCT02204124|2986726|Superiority|||||||0.401|||||||Chi-squared|||Statistical analysis #2 is for wound infection.|
1626193|NCT02204124|2986726|Superiority|||||||0.975|||||||Chi-squared|||Statistical analysis #1 is for readmission|
1626194|NCT02204124|2986727|Superiority|||||||0.132|||||||Chi-squared||||
1626195|NCT02204124|2986728|Superiority|||||||0.013|||||||Wilcoxon (Mann-Whitney)||||
1626196|NCT02204124|2986731|Superiority|||||||0.513|||||||Chi-squared||||
1626197|NCT02204124|2986732|Superiority|||||||0.032|||||||Wilcoxon (Mann-Whitney)||||
1626198|NCT02203916|2986739|Superiority or Other||LS Mean Difference|-14.955|Standard Error of the Mean|2.447|<|0.001|2-Sided|95.0|-19.77|-10.141||Overall type 1 error rate of 0.05 was controlled using principle of ‘closed’ testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis “all treatment groups equal” was first rejected at 0.05.|ANCOVA|Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.|||
1626199|NCT02203916|2986739|Superiority or Other||LS Mean Difference|-13.317|Standard Error of the Mean|2.4502|<|0.001|2-Sided|95.0|-18.138|-8.497||Overall type 1 error rate of 0.05 was controlled using principle of ‘closed’ testing: each pairwise comparison to placebo was conducted at 0.05 level with no p-value adjustment if hypothesis “all treatment groups equal” was first rejected at 0.05.|ANCOVA|Post-baseline p-values were from an ANCOVA model with treatment as a fixed factor and baseline values as a continuous covariate.|||
1626200|NCT02203357|2986815|Superiority||||||<|0.05||||||The p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance.|ANOVA||||
1626201|NCT02203331|2986820|Superiority or Other||Sigmoidal Emax 2|0.1835|Standard Error of the Mean|0.2899||0.3396|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.|
1626202|NCT02203331|2986820|Superiority or Other||Sigmoidal Emax 1|0.0401|Standard Error of the Mean|0.2829||0.5337|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.|
1626203|NCT02203331|2986820|Superiority or Other||Linear|0.1148|Standard Error of the Mean|0.288||0.4301|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.|
1626204|NCT02203331|2986820|Superiority or Other||Emax|0.0081|Standard Error of the Mean|0.2832||0.5794|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.|
1626205|NCT02203331|2986821|Superiority or Other||Sigmoidal Emax 2|0.3781|Standard Error of the Mean|0.2944||0.1416|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.|
1626206|NCT02203331|2986821|Superiority or Other||Sigmoidal Emax 1|0.3081|Standard Error of the Mean|0.2875||0.1955|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.|
1626207|NCT02203331|2986821|Superiority or Other||Linear|0.3234|Standard Error of the Mean|0.2927||0.1865|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.|
1626208|NCT02203331|2986821|Superiority or Other||Emax|0.2736|Standard Error of the Mean|0.2878||0.231|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.|
1626209|NCT02203331|2986822|Superiority or Other||Sigmoidal Emax 2|0.3467|Standard Error of the Mean|0.2994||0.1721|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.|
1626210|NCT02203331|2986822|Superiority or Other||Sigmoidal Emax 1|0.1995|Standard Error of the Mean|0.2922||0.3211|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.|
1626211|NCT02203331|2986822|Superiority or Other||Linear|0.2484|Standard Error of the Mean|0.2975||0.2676|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.|
1626212|NCT02203331|2986822|Superiority or Other||Emax|0.1483|Standard Error of the Mean|0.2925||0.3875|||||||Contrast tests for dose-response model|||The analysis was performed by using MCP-Mod method using pre-defined candidate dose-response model.|
1626213|NCT02203149|2986826|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|95.0|-6.0|2.8||||||95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.|
1626701|NCT02194933|2987779|Superiority or Other|||||||0.8437|||||||Mixed Models Analysis||||
1626214|NCT02203149|2986827|Superiority or Other||Difference in Percentage|-2.8|||||2-Sided|95.0|-14.5|10.0||||||95% confidence intervals were provided for between-treatment differences in the percentage of participants with events, comparing participants in the Part 2 Immediate Treatment (Grazoprevir + Elbasvir) Arm with the Part 2 Deferred Treatment (Placebo) Arm during the double blinded period through FUWK4. These analyses were performed using the Miettinen and Nurminen method, an unconditional, asymptotic method.|
1626215|NCT02203071|2986833|Superiority|||||||1|||||||Fisher Exact||||
1626216|NCT02203071|2986834|Superiority||||||<|0.001|||||||ANOVA||||
1626217|NCT02203071|2986835|Superiority||||||<|0.007|||||||ANOVA||||
1626218|NCT02203071|2986836|Superiority||||||>|0.11|||||||t-test, 2 sided||||
1626219|NCT02203071|2986837|Superiority|||||||0.001|||||||t-test, 2 sided||||
1626220|NCT02203071|2986838|Superiority|||||||0.61|||||||Fisher Exact||||
1626221|NCT02203032|2986839|Superiority or Other||||||=|0|||||||Cochran-Mantel-Haenszel||||
1626222|NCT02203032|2986840|Superiority or Other||||||<|0.001|||||||Row mean score test||||
1626223|NCT02203032|2986841|Superiority or Other||||||<|0.001|||||||Row mean score test||||
1626224|NCT02203032|2986842|Superiority or Other||||||<|0.001|||||||Row mean score test||||
1626225|NCT02203019|2986843|Equivalence|Outcomes were compared using a Chi square test.||||||0.739|||||||Chi-squared||||
1626226|NCT02203019|2986844|Equivalence|Outcomes were compared using a Mann Whitney U test.||||||0.376|||||||Wilcoxon (Mann-Whitney)||||
1626227|NCT02203019|2986845|Equivalence|Outcomes were compared using a Mann Whitney U test.||||||0.26|||||||Wilcoxon (Mann-Whitney)||||
1626228|NCT02203019|2986846|Equivalence|Outcome comparison used the Mann Whitney U test||||||0.107|||||||Wilcoxon (Mann-Whitney)||||
1626229|NCT02202616|2986927|Other||Mean Difference (Final Values)|-6.5|Standard Deviation|7.03|||2-Sided|95.0|-7.3|-5.7||||||Week 16|
1626230|NCT02202616|2986927|Other||Mean Difference (Final Values)|-5.0|Standard Deviation|6.25|||2-Sided|95.0|-5.7|-4.3||||||Week 4|
1626231|NCT02202616|2986928|Other||Mean Difference (Final Values)|2.5|Standard Deviation|2.92|||2-Sided|95.0|2.21|2.85||||||Week 16|
1626232|NCT02202616|2986928|Other||Mean Difference (Final Values)|2.0|Standard Deviation|2.47|||2-Sided|95.0|1.74|2.3||||||Week 4|
1626233|NCT02202616|2986929|Other||Mean Difference (Final Values)|0.14|Standard Deviation|0.278|||2-Sided|95.0|0.11|0.17|||||||
1626234|NCT02202616|2986930|Other||Mean Difference (Final Values)|0.17|Standard Deviation|0.34|||2-Sided|95.0|0.14|0.21|||||||
1626235|NCT02202434|2986973|Superiority||Difference in Percentages|-6.1|||<|0.0001|2-Sided|95.0|-9.6|-2.6|||Chi-squared||||
1626236|NCT02202434|2986974|Superiority||Difference in Percentages|-10.2||||0.0006|2-Sided|95.0|-16.3|-4.0|||Chi-squared|||"Superiority analysis was only to be run if the non-inferiority analysis was met.~Superiority analysis was run on Intent to Treat Population."|
1626237|NCT02202434|2986974|Non-Inferiority|9.5% Non-Inferiority margin|Difference in Percentages|-10.1|||<|0.0001|1-Sided|97.5||-4.41|||Farrington-Manning||||
1626238|NCT02202434|2986975|Non-Inferiority|10.5% non-inferiority margin|Difference in Percentages|3.1||||0.0027|1-Sided|97.5||8.32|||Farrington-Manning||||
1626239|NCT02202252|2986979|Superiority or Other|||||||0.819|||||||Wilcoxon (Mann-Whitney)||||
1626240|NCT02202252|2986980|Superiority or Other|||||||0.035|||||||Chi-squared||||
1626241|NCT02202252|2986981|Superiority or Other|||||||0.49|||||||Wilcoxon (Mann-Whitney)||||
1626242|NCT02202161|2986985|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.9|||||2-Sided|95.0|0.8|1.02|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.|
1626243|NCT02202161|2986985|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.73|||||2-Sided|95.0|0.64|0.83|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.|
1626244|NCT02202161|2986985|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.67|||||2-Sided|95.0|0.58|0.77|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.|
1626245|NCT02202161|2986985|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.8|||||2-Sided|95.0|0.7|0.91|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.|
1626246|NCT02202161|2986985|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.81|||||2-Sided|95.0|0.68|0.95|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.|
1626247|NCT02202161|2986985|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.91|||||2-Sided|95.0|0.77|1.07|||||Comparison for Day 14, apolipoprotein B|An estimation approach was used.|
1626248|NCT02202161|2986985|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||2-Sided|95.0|0.89|1.06|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.|
1626249|NCT02202161|2986985|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||2-Sided|95.0|0.7|0.85|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.|
1626250|NCT02202161|2986985|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||2-Sided|95.0|0.63|0.77|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.|
1626356|NCT02202031|2987019|Superiority|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic|Mean Difference (Final Values)|0.14||||0.5578|2-Sided|95.0|-0.32|0.6|||ANCOVA||||
1626251|NCT02202161|2986985|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||2-Sided|95.0|0.74|0.9|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.|
1626252|NCT02202161|2986985|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.79|||||2-Sided|95.0|0.71|0.89|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.|
1626253|NCT02202161|2986985|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||2-Sided|95.0|0.87|1.11|||||Comparison for Day 7, apolipoprotein B|An estimation approach was used.|
1626254|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.89|||||2-Sided|95.0|0.72|1.11|||||Comparison for Day 14, triglycerides|An estimation approach was used.|
1626255|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.23|||||2-Sided|95.0|0.96|1.57|||||Comparison for Day 14, triglycerides|An estimation approach was used.|
1626256|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.22|||||2-Sided|95.0|0.95|1.56|||||Comparison for Day 14, triglycerides|An estimation approach was used.|
1626257|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.24|||||2-Sided|95.0|0.98|1.58|||||Comparison for Day 14, triglycerides|An estimation approach was used.|
1626258|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.28|||||2-Sided|95.0|0.94|1.75|||||Comparison for Day 14, triglycerides|An estimation approach was used.|
1626259|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.42|||||2-Sided|95.0|1.01|2.0|||||Comparison for Day 14, triglycerides|An estimation approach was used.|
1626260|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.91|||||2-Sided|95.0|0.8|1.04|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.|
1626261|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||2-Sided|95.0|0.6|0.81|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.|
1626262|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.65|||||2-Sided|95.0|0.55|0.75|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.|
1626263|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||2-Sided|95.0|0.67|0.9|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.|
1626264|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||2-Sided|95.0|0.64|0.93|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.|
1626265|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.99|||||2-Sided|95.0|0.8|1.22|||||Comparison for Day 14, non-HDL cholesterol|An estimation approach was used.|
1626266|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.94|||||2-Sided|95.0|0.81|1.09|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.|
1626267|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.69|||||2-Sided|95.0|0.59|0.8|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.|
1626268|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.6|||||2-Sided|95.0|0.5|0.71|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.|
1626269|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.73|||||2-Sided|95.0|0.62|0.86|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.|
1626270|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.7|||||2-Sided|95.0|0.58|0.85|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.|
1626271|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.85|||||2-Sided|95.0|0.69|1.04|||||Comparison for Day 14, LDL cholesterol|An estimation approach was used.|
1626272|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||2-Sided|95.0|0.92|1.04|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.|
1626702|NCT02194933|2987782|Superiority or Other|||||||0.3375|||||||Mixed Models Analysis||||
1626273|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.01|||||2-Sided|95.0|0.94|1.08|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.|
1626274|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.99|||||2-Sided|95.0|0.92|1.06|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.|
1626275|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||2-Sided|95.0|0.9|1.04|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.|
1626276|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.02|||||2-Sided|95.0|0.93|1.11|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.|
1626277|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.09|||||2-Sided|95.0|0.99|1.21|||||Comparison for Day 14, HDL cholesterol|An estimation approach was used.|
1626278|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.93|||||2-Sided|95.0|0.84|1.03|||||Comparison for Day 14, cholesterol|An estimation approach was used.|
1626279|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||2-Sided|95.0|0.69|0.86|||||Comparison for Day 14, cholesterol|An estimation approach was used.|
1626280|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.74|||||2-Sided|95.0|0.66|0.82|||||Comparison for Day 14, cholesterol|An estimation approach was used.|
1626281|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||2-Sided|95.0|0.73|0.91|||||Comparison for Day 14, cholesterol|An estimation approach was used.|
1626282|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.83|||||2-Sided|95.0|0.73|0.96|||||Comparison for Day 14, cholesterol|An estimation approach was used.|
1626283|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.0|||||2-Sided|95.0|0.86|1.17|||||Comparison for Day 14, cholesterol|An estimation approach was used.|
1626284|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.95|||||2-Sided|95.0|0.79|1.16|||||Comparison for Day 7, triglycerides|An estimation approach was used.|
1626285|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.15|||||2-Sided|95.0|0.93|1.42|||||Comparison for Day 7, triglycerides|An estimation approach was used.|
1626286|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.19|||||2-Sided|95.0|0.96|1.48|||||Comparison for Day 7, triglycerides|An estimation approach was used.|
1626287|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.3|||||2-Sided|95.0|1.06|1.61|||||Comparison for Day 7, triglycerides|An estimation approach was used.|
1626288|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.16|||||2-Sided|95.0|0.9|1.5|||||Comparison for Day 7, triglycerides|An estimation approach was used.|
1626289|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.27|||||2-Sided|95.0|0.97|1.66|||||Comparison for Day 7, triglycerides|An estimation approach was used.|
1626290|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.02|||||2-Sided|95.0|0.92|1.14|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.|
1626291|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.77|||||2-Sided|95.0|0.68|0.87|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.|
1626292|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.67|||||2-Sided|95.0|0.59|0.76|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.|
1626293|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.84|||||2-Sided|95.0|0.74|0.95|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.|
1626294|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.82|||||2-Sided|95.0|0.71|0.95|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.|
1626703|NCT02194933|2987782|Superiority or Other|||||||0.4138|||||||Mixed Models Analysis||||
1626295|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.03|||||2-Sided|95.0|0.88|1.21|||||Comparison for Day 7, non-HDL cholesterol|An estimation approach was used.|
1626296|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.0|||||2-Sided|95.0|0.89|1.14|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.|
1626297|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.71|||||2-Sided|95.0|0.62|0.81|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.|
1626298|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.59|||||2-Sided|95.0|0.51|0.69|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.|
1626299|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.74|||||2-Sided|95.0|0.64|0.85|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.|
1626300|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.76|||||2-Sided|95.0|0.65|0.9|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.|
1626301|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.95|||||2-Sided|95.0|0.8|1.13|||||Comparison for Day 7, LDL cholesterol|An estimation approach was used.|
1626302|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.97|||||2-Sided|95.0|0.9|1.05|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.|
1626303|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.07|||||2-Sided|95.0|0.98|1.17|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.|
1626304|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.98|||||2-Sided|95.0|0.89|1.07|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.|
1626305|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.96|||||2-Sided|95.0|0.88|1.05|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.|
1626306|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.04|||||2-Sided|95.0|0.94|1.16|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.|
1626307|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.07|||||2-Sided|95.0|0.95|1.19|||||Comparison for Day 7, HDL cholesterol|An estimation approach was used.|
1626308|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.01|||||2-Sided|95.0|0.92|1.1|||||Comparison for Day 7, cholesterol|An estimation approach was used.|
1626309|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.83|||||2-Sided|95.0|0.76|0.92|||||Comparison for Day 7, cholesterol|An estimation approach was used.|
1626310|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.75|||||2-Sided|95.0|0.68|0.83|||||Comparison for Day 7, cholesterol|An estimation approach was used.|
1626311|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.86|||||2-Sided|95.0|0.78|0.95|||||Comparison for Day 7, cholesterol|An estimation approach was used.|
1626312|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|0.88|||||2-Sided|95.0|0.78|0.98|||||Comparison for Day 7, cholesterol|An estimation approach was used.|
1626313|NCT02202161|2986986|Superiority or Other|Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Mean Difference (Net)|1.03|||||2-Sided|95.0|0.91|1.17|||||Comparison for Day 7, cholesterol|An estimation approach was used.|
1626314|NCT02202161|2986987|Superiority or Other|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.24|||||2-Sided|90.0|1.04|1.48|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.||
1626315|NCT02202161|2986987|Superiority or Other|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.23|||||2-Sided|90.0|1.01|1.49|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.||
1626316|NCT02202161|2986987|Superiority or Other|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.19|||||2-Sided|90.0|0.97|1.45|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.||
1626317|NCT02202161|2986987|Superiority or Other|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.04|||||2-Sided|90.0|0.85|1.26|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.||
1626318|NCT02202161|2986987|Superiority or Other|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|1.04|||||2-Sided|90.0|0.82|1.31|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.||
1626319|NCT02202161|2986987|Superiority or Other|Each GSK2330672 dose level was compared to placebo using an ANOVA model following log-transformation.|Ratio|0.88|||||2-Sided|90.0|0.68|1.13|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.||
1626320|NCT02202161|2986989|Superiority or Other|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.11|||||2-Sided|90.0|0.94|1.31|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.||
1626321|NCT02202161|2986989|Superiority or Other|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.25|||||2-Sided|90.0|1.04|1.5|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.||
1626322|NCT02202161|2986989|Superiority or Other|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.25|||||2-Sided|90.0|1.03|1.52|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.||
1626323|NCT02202161|2986989|Superiority or Other|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.05|||||2-Sided|90.0|0.87|1.27|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.||
1626324|NCT02202161|2986989|Superiority or Other|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.11|||||2-Sided|90.0|0.89|1.38|||||Mean and CI for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.||
1626325|NCT02202161|2986989|Superiority or Other|Each GSK2330672 dose level was compared to placebo using an analysis of variance (ANOVA) model of log-transformed values.|Ratio|1.17|||||2-Sided|90.0|0.92|1.49|||||Mean and confidence interval (CI) for the difference in least squares means (Active-Placebo) are back-transformed to form the point estimate and associated CI for the ratio of geometric means.||
1626326|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-19.45|||||2-Sided|95.0|-34.96|-3.93|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.|
1626327|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-23.94|||||2-Sided|95.0|-41.49|-6.39|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.|
1626328|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-17.01|||||2-Sided|95.0|-34.56|0.53|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.|
1626329|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-15.23|||||2-Sided|95.0|-32.86|2.41|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.|
1626330|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|4.8|||||2-Sided|95.0|-16.22|25.81|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.|
1626331|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-11.2|||||2-Sided|95.0|-33.21|10.81|||||Comparison for WM AUC(0-24 hour), Day 14|An estimation approach was used.|
1626332|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-18.01|||||2-Sided|95.0|-33.48|-2.55|||||Comparison for fasting, Day 14|An estimation approach was used.|
1626333|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.82|||||2-Sided|95.0|-38.56|-5.08|||||Comparison for fasting, Day 14|An estimation approach was used.|
1626334|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-19.97|||||2-Sided|95.0|-37.12|-2.82|||||Comparison for fasting, Day 14|An estimation approach was used.|
1626357|NCT02202031|2987020|Superiority||Mean Difference (Final Values)|0.08||||0.8408|2-Sided|95.0|-0.66|0.81|||ANCOVA|change from baseline, adjusted for baseline value|||
1626335|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-25.29|||||2-Sided|95.0|-42.56|-8.02|||||Comparison for fasting, Day 14|An estimation approach was used.|
1626336|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|4.33|||||2-Sided|95.0|-15.91|24.57|||||Comparison for fasting, Day 14|An estimation approach was used.|
1626337|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-12.1|||||2-Sided|95.0|-33.56|9.36|||||Comparison for fasting, Day 14|An estimation approach was used.|
1626338|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-26.03|||||2-Sided|95.0|-41.94|-10.12|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.|
1626339|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-10.62|||||2-Sided|95.0|-28.62|7.38|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.|
1626340|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.7|||||2-Sided|95.0|-39.7|-3.71|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.|
1626341|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-20.66|||||2-Sided|95.0|-38.75|-2.57|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.|
1626342|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-2.1|||||2-Sided|95.0|-23.66|19.45|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.|
1626343|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-15.14|||||2-Sided|95.0|-37.72|7.43|||||Comparison for WM AUC(0-24 hour), Day 7|An estimation approach was used.|
1626344|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-10.04|||||2-Sided|95.0|-27.66|7.57|||||Comparison for fasting, Day 7|An estimation approach was used.|
1626345|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-11.79|||||2-Sided|95.0|-30.85|7.28|||||Comparison for fasting, Day 7|An estimation approach was used.|
1626346|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-23.1|||||2-Sided|95.0|-42.63|-3.57|||||Comparison for fasting, Day 7|An estimation approach was used.|
1626347|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-21.77|||||2-Sided|95.0|-41.43|-2.1|||||Comparison for fasting, Day 7|An estimation approach was used.|
1626348|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|13.22|||||2-Sided|95.0|-9.84|36.27|||||Comparison for fasting, Day 7|An estimation approach was used.|
1626349|NCT02202161|2987004|Superiority or Other|An analysis of covariance (ANCOVA) model with a fixed effect term for treatment was fitted with the post-Baseline pharmacodynamic parameter value minus Baseline (Day -1 parameter value) as the dependent variable and Baseline as a covariate.|Mean Difference (Net)|-1.17|||||2-Sided|95.0|-25.61|23.27|||||Comparison for fasting, Day 7|An estimation approach was used.|
1626350|NCT02202031|2987013|Superiority||Mean Difference (Final Values)|-1.55||||0.6268|2-Sided|95.0|-6.98|3.87|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.|||
1626351|NCT02202031|2987014|Superiority||Mean Difference (Final Values)|0.59||||0.7506|2-Sided|95.0|-3.05|4.23|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.|||
1626352|NCT02202031|2987015|Superiority|||||||0.4993|||||||ANCOVA|Adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.|||
1626353|NCT02202031|2987016|Superiority||Mean Difference (Final Values)|-0.43||||0.6646|2-Sided|95.0|-0.89|0.04|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic|||
1626354|NCT02202031|2987017|Superiority||Mean Difference (Final Values)|-0.24||||0.7301|2-Sided|95.0|-0.79|0.31|||ANCOVA|adjusted for baseline value, diabetes and the following medications: beta-blockers, alpha-agonists, and sympathomimetic.|||
1626358|NCT02202031|2987021|Superiority||Mean Difference (Final Values)|-1.71||||0.0335|2-Sided|95.0|-3.28|-0.13|||ANCOVA|change from baseline, adjusted for baseline value|||
1626359|NCT02202031|2987022|Superiority||Mean Difference (Final Values)|-1.04||||0.2284|2-Sided|95.0|-2.87|0.79|||ANCOVA|change from baseline, adjusted for baseline value|||
1626360|NCT02202031|2987023|Superiority||Mean Difference (Final Values)|-0.67||||0.0786|2-Sided|95.0|-1.4|0.07|||ANCOVA|change from baseline, adjusted for baseline value|||
1626361|NCT02202031|2987024|Superiority||Mean Difference (Final Values)|-0.43||||0.6722|2-Sided|95.0|-2.43|1.57|||ANCOVA|change from baseline, adjusted for baseline value|||
1626362|NCT02202031|2987025|Superiority||Mean Difference (Final Values)|-0.14||||0.3611|2-Sided|95.0|-0.44|0.16|||ANCOVA|change from baseline, adjusted for baseline value|||
1626363|NCT02202031|2987026|Superiority||Mean Difference (Final Values)|-1.76||||0.5146|2-Sided|95.0|-7.05|3.53|||ANCOVA|change from baseline, adjusted for baseline value|||
1626364|NCT02202031|2987027|Superiority||Mean Difference (Final Values)|2.17||||0.3134|2-Sided|95.0|-2.05|6.38|||ANCOVA|change from baseline, adjusted for baseline value|||
1626365|NCT02202031|2987028|Superiority||Mean Difference (Final Values)|1.72||||0.4663|2-Sided|95.0|-2.9|6.34|||ANCOVA|change from baseline, adjusted for baseline value|||
1626366|NCT02202031|2987029|Superiority||Mean Difference (Final Values)|1.16||||0.5358|2-Sided|95.0|-2.51|4.84|||ANCOVA|change from baseline, adjusted for baseline value.|||
1626367|NCT02202031|2987030|Superiority||Mean Difference (Final Values)|-0.03||||0.919|2-Sided|95.0|-0.66|0.6|||ANCOVA|change from baseline, adjusted for baseline value|||
1626368|NCT02202031|2987031|Superiority||Mean Difference (Final Values)|0.07||||0.6456|2-Sided|95.0|-0.24|0.39|||ANCOVA|change from baseline value, adjusted for baseline value|||
1626369|NCT02202031|2987032|Superiority||Mean Difference (Final Values)|-0.08||||0.7695|2-Sided|95.0|-0.64|0.47|||ANCOVA|change from baseline, adjusted for baseline value|||
1626370|NCT02202031|2987033|Superiority||Mean Difference (Final Values)|0.24||||0.6222|2-Sided|95.0|-0.73|1.21|||ANCOVA|change from baseline, adjusted for baseline value|||
1626371|NCT02201953|2987039|Superiority or Other||||||<|0.001||||||P-value was from the Cochran-Mantel-Haenszel test stratified by cirrhosis status and prior HCV treatment experience.|Cochran-Mantel-Haenszel|||If the lower bound of 95% CI on the difference was > -10%, the p-value tested for the superiority of SOF/VEL for 12 weeks over SOF+RBV for 24 weeks. Superiority was demonstrated if the two-sided p-value is less than 0.05.|
1626372|NCT02201953|2987039|Non-Inferiority or Equivalence|Primary analyses consisted of non-inferiority test of Group 1 (SOF/VEL 12 weeks) versus Group 2 (SOF+RBV 24 weeks) at the 0.05 significance level. Non-inferiority was assessed using the conventional confidence interval approach and a non-inferiority margin of 10% was applied. The two-sided 95% confidence intervals was constructed using stratum-adjusted Mantel-Haenszel proportions, stratified by the randomization stratification factors (i.e cirrhosis status and prior treatment experience)|Difference in proportions|14.4|||<||2-Sided|95.0|9.2|19.6|||||Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.||
1626373|NCT02201940|2987045|Superiority or Other||||||<|0.001||||||Participants in the SOF/VEL group were compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.|Binomial test||||
1626374|NCT02201901|2987053|Superiority or Other||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 24 weeks (Group 3) over prespecified rate of 1%.||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.|
1626375|NCT02201901|2987053|Superiority or Other||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 weeks (Group 2) over prespecified rate of 1%.||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.|
1626376|NCT02201901|2987053|Superiority or Other||||||<|0.001|||||||Binomial test|P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 12 weeks (Group 1) over prespecified rate of 1% .||A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.|
1626377|NCT02201524|2987080|Superiority or Other||Difference in Percentage|12.5|||||2-Sided|90.0|-26.4|48.1||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.|
1626378|NCT02201524|2987080|Superiority or Other||Difference in Percentage|20.5|||||2-Sided|90.0|-17.6|51.9||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.|
1626379|NCT02201524|2987080|Superiority or Other||Difference in Percentage|2.3|||||2-Sided|90.0|-33.2|34.6||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.|
1626380|NCT02201524|2987080|Superiority or Other||Difference in Percentage|13.6|||||2-Sided|90.0|-21.9|46.2||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.|
1626381|NCT02201524|2987080|Superiority or Other||Difference in Percentage|3.6|||||2-Sided|90.0|-30.5|37.3||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.|
1626382|NCT02201524|2987080|Superiority or Other||Difference in Percentage|9.1|||||2-Sided|90.0|-25.2|41.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.|
1626383|NCT02201524|2987080|Superiority or Other||Difference in Percentage|50.5|||||2-Sided|90.0|12.9|75.3||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.|
1626384|NCT02201524|2987080|Superiority or Other||Difference in Percentage|14.4|||||2-Sided|90.0|-18.9|44.5||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.|
1626385|NCT02201524|2987080|Superiority or Other||Difference in Percentage|6.1|||||2-Sided|90.0|-26.1|36.6||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.|
1626704|NCT02194933|2987783|Superiority or Other|||||||0.1778|||||||Mixed Models Analysis||||
1626386|NCT02201524|2987080|Superiority or Other||Difference in Percentage|53.3|||||2-Sided|90.0|18.5|76.6||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.|
1626387|NCT02201524|2987080|Superiority or Other||Difference in Percentage|41.7|||||2-Sided|90.0|8.7|66.7||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.|
1626388|NCT02201524|2987080|Superiority or Other||Difference in Percentage|25.0|||||2-Sided|90.0|-6.4|52.5||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.|
1626389|NCT02201524|2987080|Superiority or Other||Difference in Percentage|30.1|||||2-Sided|90.0|-1.2|57.4||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.|
1626390|NCT02201524|2987080|Superiority or Other||Difference in Percentage|31.3|||||2-Sided|90.0|1.7|55.7||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.|
1626391|NCT02201524|2987080|Superiority or Other||Difference in Percentage|17.9|||||2-Sided|90.0|-11.2|45.5||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.|
1626392|NCT02201524|2987080|Superiority or Other||Difference in Percentage|34.5|||||2-Sided|90.0|7.3|59.4||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.|
1626393|NCT02201524|2987080|Superiority or Other||Difference in Percentage|15.9|||||2-Sided|90.0|-8.1|40.7||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.|
1626394|NCT02201524|2987080|Superiority or Other||Difference in Percentage|21.4|||||2-Sided|90.0|-3.2|45.5||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.|
1626395|NCT02201524|2987080|Superiority or Other||Difference in Percentage|7.1|||||2-Sided|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.|
1626396|NCT02201524|2987080|Superiority or Other||Difference in Percentage|12.5|||||2-Sided|90.0|-5.2|32.0||||||PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.|
1626397|NCT02201524|2987080|Superiority or Other||Difference in Percentage|13.3|||||2-Sided|90.0|-4.4|33.8||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.|
1626398|NCT02201524|2987081|Superiority or Other||Difference in Percentage|25.0|||||2-Sided|90.0|-4.9|54.9||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.|
1626399|NCT02201524|2987081|Superiority or Other||Difference in Percentage|30.0|||||2-Sided|90.0|6.4|56.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.|
1626400|NCT02201524|2987081|Superiority or Other||Difference in Percentage|20.0|||||2-Sided|90.0|-2.7|46.6||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.|
1626401|NCT02201524|2987081|Superiority or Other||Difference in Percentage|44.4|||||2-Sided|90.0|19.4|70.2||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.|
1626402|NCT02201524|2987081|Superiority or Other||Difference in Percentage|25.0|||||2-Sided|90.0|2.1|49.3||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.|
1626403|NCT02201524|2987081|Superiority or Other||Difference in Percentage|60.0|||||2-Sided|90.0|34.7|80.9||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.|
1626404|NCT02201524|2987081|Superiority or Other||Difference in Percentage|33.3|||||2-Sided|90.0|11.3|57.3||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.|
1626405|NCT02201524|2987081|Superiority or Other||Difference in Percentage|36.4|||||2-Sided|90.0|15.3|61.1||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.|
1626406|NCT02201524|2987081|Superiority or Other||Difference in Percentage|13.3|||||2-Sided|90.0|-5.6|33.8||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.|
1626407|NCT02201524|2987081|Superiority or Other||Difference in Percentage|1.2|||||2-Sided|90.0|-20.3|24.8||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.|
1626408|NCT02201524|2987081|Superiority or Other||Difference in Percentage|0.5|||||2-Sided|90.0|-20.7|22.8||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.|
1626409|NCT02201524|2987081|Superiority or Other||Difference in Percentage|-7.1|||||2-Sided|90.0|-27.0|10.2||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.|
1626410|NCT02201524|2987081|Superiority or Other||Difference in Percentage|7.1|||||2-Sided|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.|
1626411|NCT02201524|2987082|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|90.0|-36.4|36.4||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.|
1626412|NCT02201524|2987082|Superiority or Other||Difference in Percentage|-6.8|||||2-Sided|90.0|-40.6|24.8||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.|
1626413|NCT02201524|2987082|Superiority or Other||Difference in Percentage|-15.9|||||2-Sided|90.0|-47.8|13.7||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.|
1626414|NCT02201524|2987082|Superiority or Other||Difference in Percentage|31.8|||||2-Sided|90.0|-2.9|60.5||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.|
1626415|NCT02201524|2987082|Superiority or Other||Difference in Percentage|41.8|||||2-Sided|90.0|6.2|68.5||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.|
1626416|NCT02201524|2987082|Superiority or Other||Difference in Percentage|-9.1|||||2-Sided|90.0|-36.3|18.3||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.|
1626417|NCT02201524|2987082|Superiority or Other||Difference in Percentage|66.7|||||2-Sided|90.0|39.2|86.1||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.|
1626418|NCT02201524|2987082|Superiority or Other||Difference in Percentage|50.0|||||2-Sided|90.0|25.4|71.8||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.|
1626419|NCT02201524|2987082|Superiority or Other||Difference in Percentage|25.0|||||2-Sided|90.0|2.1|49.3||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.|
1626420|NCT02201524|2987082|Superiority or Other||Difference in Percentage|43.3|||||2-Sided|90.0|8.8|69.3||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.|
1626421|NCT02201524|2987082|Superiority or Other||Difference in Percentage|33.3|||||2-Sided|90.0|1.0|59.8||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.|
1626422|NCT02201524|2987082|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|90.0|-27.3|27.3||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.|
1626423|NCT02201524|2987082|Superiority or Other||Difference in Percentage|28.7|||||2-Sided|90.0|0.8|55.3||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.|
1626424|NCT02201524|2987082|Superiority or Other||Difference in Percentage|32.3|||||2-Sided|90.0|5.4|55.4||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.|
1626425|NCT02201524|2987082|Superiority or Other||Difference in Percentage|-7.7|||||2-Sided|90.0|-28.8|12.1||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.|
1626426|NCT02201524|2987082|Superiority or Other||Difference in Percentage|17.9|||||2-Sided|90.0|-6.7|43.6||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.|
1626427|NCT02201524|2987082|Superiority or Other||Difference in Percentage|8.2|||||2-Sided|90.0|-14.4|32.2||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.|
1626428|NCT02201524|2987082|Superiority or Other||Difference in Percentage|-7.1|||||2-Sided|90.0|-27.0|10.2||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.|
1626429|NCT02201524|2987082|Superiority or Other||Difference in Percentage|7.1|||||2-Sided|90.0|-10.2|27.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.|
1626430|NCT02201524|2987083|Superiority or Other||Difference in Percentage|12.5|||||2-Sided|90.0|-28.0|49.3||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.|
1626431|NCT02201524|2987083|Superiority or Other||Difference in Percentage|13.6|||||2-Sided|90.0|-23.7|48.2||||||PF-04965842 400 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.|
1626432|NCT02201524|2987083|Superiority or Other||Difference in Percentage|-4.5|||||2-Sided|90.0|-40.4|32.3||||||PF-04965842 200 mg vs Placebo at Week 8: Analysed using Asymptotic Miettinen and Nurminen method.|
1626433|NCT02201524|2987083|Superiority or Other||Difference in Percentage|24.5|||||2-Sided|90.0|-11.8|54.9||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.|
1626434|NCT02201524|2987083|Superiority or Other||Difference in Percentage|14.5|||||2-Sided|90.0|-21.4|47.0||||||PF-04965842 400 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.|
1626435|NCT02201524|2987083|Superiority or Other||Difference in Percentage|36.4|||||2-Sided|90.0|1.9|63.4||||||PF-04965842 200 mg vs Placebo at Week 6: Analysed using Asymptotic Miettinen and Nurminen method.|
1626436|NCT02201524|2987083|Superiority or Other||Difference in Percentage|45.5|||||2-Sided|90.0|17.1|69.0||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.|
1626437|NCT02201524|2987083|Superiority or Other||Difference in Percentage|3.8|||||2-Sided|90.0|-29.4|36.4||||||PF-04965842 400 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.|
1626438|NCT02201524|2987083|Superiority or Other||Difference in Percentage|12.1|||||2-Sided|90.0|-21.4|43.4||||||PF-04965842 200 mg vs Placebo at Week 5: Analysed using Asymptotic Miettinen and Nurminen method.|
1626439|NCT02201524|2987083|Superiority or Other||Difference in Percentage|55.0|||||2-Sided|90.0|19.7|77.6||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.|
1626440|NCT02201524|2987083|Superiority or Other||Difference in Percentage|41.7|||||2-Sided|90.0|7.6|67.1||||||PF-04965842 400 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.|
1626441|NCT02201524|2987083|Superiority or Other||Difference in Percentage|41.7|||||2-Sided|90.0|7.6|67.1||||||PF-04965842 200 mg vs Placebo at Week 4: Analysed using Asymptotic Miettinen and Nurminen method.|
1626442|NCT02201524|2987083|Superiority or Other||Difference in Percentage|67.8|||||2-Sided|90.0|36.4|85.3||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.|
1626443|NCT02201524|2987083|Superiority or Other||Difference in Percentage|23.6|||||2-Sided|90.0|-6.9|49.8||||||PF-04965842 400 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.|
1626444|NCT02201524|2987083|Superiority or Other||Difference in Percentage|1.9|||||2-Sided|90.0|-26.7|31.0||||||PF-04965842 200 mg vs Placebo at Week 3: Analysed using Asymptotic Miettinen and Nurminen method.|
1626445|NCT02201524|2987083|Superiority or Other||Difference in Percentage|20.2|||||2-Sided|90.0|-10.2|48.3||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.|
1626446|NCT02201524|2987083|Superiority or Other||Difference in Percentage|1.6|||||2-Sided|90.0|-25.4|29.1||||||PF-04965842 400 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.|
1626447|NCT02201524|2987083|Superiority or Other||Difference in Percentage|-14.3|||||2-Sided|90.0|-38.0|9.3||||||PF-04965842 200 mg vs Placebo at Week 2: Analysed using Asymptotic Miettinen and Nurminen method.|
1626448|NCT02201524|2987083|Superiority or Other||Difference in Percentage|14.3|||||2-Sided|90.0|-9.3|38.0||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.|
1626449|NCT02201524|2987083|Superiority or Other||Difference in Percentage|17.9|||||2-Sided|90.0|-5.9|40.3||||||PF-04965842 400 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.|
1626450|NCT02201524|2987083|Superiority or Other||Difference in Percentage|-0.5|||||2-Sided|90.0|-21.5|19.6||||||PF-04965842 200 mg vs Placebo at Week 1: Analysed using Asymptotic Miettinen and Nurminen method.|
1626451|NCT02201524|2987084|Superiority or Other||LS mean difference|-6.52|Standard Error of the Mean|2.758|||2-Sided|90.0|-11.15|-1.89||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626452|NCT02201524|2987084|Superiority or Other||LS mean difference|-2.83|Standard Error of the Mean|2.586|||2-Sided|90.0|-7.18|1.51||||||PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626453|NCT02201524|2987084|Superiority or Other||LS mean difference|-1.27|Standard Error of the Mean|2.607|||2-Sided|90.0|-5.65|3.11||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626454|NCT02201524|2987084|Superiority or Other||LS mean difference|-6.94|Standard Error of the Mean|2.412|||2-Sided|90.0|-11.0|-2.89||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626455|NCT02201524|2987084|Superiority or Other||LS mean difference|-3.8|Standard Error of the Mean|2.304|||2-Sided|90.0|-7.68|0.07||||||PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626456|NCT02201524|2987084|Superiority or Other||LS mean difference|-3.98|Standard Error of the Mean|2.321|||2-Sided|90.0|-7.89|-0.08||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626457|NCT02201524|2987084|Superiority or Other||LS mean difference|-8.59|Standard Error of the Mean|2.167|||2-Sided|90.0|-12.24|-4.95||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626458|NCT02201524|2987084|Superiority or Other||LS mean difference|-2.98|Standard Error of the Mean|2.035|||2-Sided|90.0|-6.4|0.45||||||PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626459|NCT02201524|2987084|Superiority or Other||LS mean difference|-3.25|Standard Error of the Mean|2.054|||2-Sided|90.0|-6.71|0.21||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626460|NCT02201524|2987084|Superiority or Other||LS mean difference|-9.39|Standard Error of the Mean|2.286|||2-Sided|90.0|-13.22|-5.56||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626461|NCT02201524|2987084|Superiority or Other||LS mean difference|-6.12|Standard Error of the Mean|2.177|||2-Sided|90.0|-9.78|-2.47||||||PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626462|NCT02201524|2987084|Superiority or Other||LS mean difference|-2.34|Standard Error of the Mean|2.224|||2-Sided|90.0|-6.07|1.39||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626463|NCT02201524|2987084|Superiority or Other||LS mean difference|-5.16|Standard Error of the Mean|2.084|||2-Sided|90.0|-8.65|-1.67||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626464|NCT02201524|2987084|Superiority or Other||LS mean difference|-3.86|Standard Error of the Mean|2.011|||2-Sided|90.0|-7.23|-0.49||||||PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626465|NCT02201524|2987084|Superiority or Other||LS mean difference|-1.08|Standard Error of the Mean|2.032|||2-Sided|90.0|-4.49|2.32||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626466|NCT02201524|2987084|Superiority or Other||LS mean difference|-3.65|Standard Error of the Mean|1.668|||2-Sided|90.0|-6.45|-0.86||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626467|NCT02201524|2987084|Superiority or Other||LS mean difference|-2.31|Standard Error of the Mean|1.603|||2-Sided|90.0|-4.99|0.38||||||PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626468|NCT02201524|2987084|Superiority or Other||LS mean difference|-2.01|Standard Error of the Mean|1.626|||2-Sided|90.0|-4.73|0.72||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626469|NCT02201524|2987085|Superiority or Other||LS mean difference|-34.46|Standard Error of the Mean|13.69|||2-Sided|90.0|-57.44|-11.48||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626470|NCT02201524|2987085|Superiority or Other||LS mean difference|-13.03|Standard Error of the Mean|12.902|||2-Sided|90.0|-34.71|8.64||||||PF-04965842 400 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626471|NCT02201524|2987085|Superiority or Other||LS mean difference|-10.75|Standard Error of the Mean|12.985|||2-Sided|90.0|-32.57|11.07||||||PF-04965842 200 mg vs Placebo at Week 8: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626472|NCT02201524|2987085|Superiority or Other||LS mean difference|-35.88|Standard Error of the Mean|11.893|||2-Sided|90.0|-55.85|-15.9||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626473|NCT02201524|2987085|Superiority or Other||LS mean difference|-17.75|Standard Error of the Mean|11.416|||2-Sided|90.0|-36.92|1.42||||||PF-04965842 400 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626586|NCT02197130|2987358|Superiority or Other||Mean Difference (Net)|0.12|Standard Error of the Mean|0.163||0.4657|2-Sided|90.0|-0.15|0.39|||MMRM|||Week 26|
1626705|NCT02194933|2987783|Superiority or Other|||||||0.2061|||||||Mixed Models Analysis||||
1626474|NCT02201524|2987085|Superiority or Other||LS mean|-21.75|Standard Error of the Mean|11.459|||2-Sided|90.0|-41.0|-2.49||||||PF-04965842 200 mg vs Placebo at Week 6: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626475|NCT02201524|2987085|Superiority or Other||LS mean difference|-47.94|Standard Error of the Mean|11.125|||2-Sided|90.0|-66.61|-29.27||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626476|NCT02201524|2987085|Superiority or Other||LS mean difference|-14.78|Standard Error of the Mean|10.513|||2-Sided|90.0|-32.44|2.88||||||PF-04965842 400 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626477|NCT02201524|2987085|Superiority or Other||LS mean difference|-17.98|Standard Error of the Mean|10.605|||2-Sided|90.0|-35.8|-0.15||||||PF-04965842 200 mg vs Placebo at Week 5: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626478|NCT02201524|2987085|Superiority or Other||LS mean difference|-52.63|Standard Error of the Mean|11.697|||2-Sided|90.0|-72.24|-33.02||||||PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626479|NCT02201524|2987085|Superiority or Other||LS mean difference|-27.47|Standard Error of the Mean|11.155|||2-Sided|90.0|-46.18|-8.75||||||PF-04965842 400 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626480|NCT02201524|2987085|Superiority or Other||LS mean difference|-24.25|Standard Error of the Mean|11.33|||2-Sided|90.0|-43.26|-5.24||||||PF-04965842 200 mg vs Placebo at Week 4: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626481|NCT02201524|2987085|Superiority or Other||LS mean difference|-49.99|Standard Error of the Mean|11.299|||2-Sided|90.0|-68.92|-31.05||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626482|NCT02201524|2987085|Superiority or Other||LS mean difference|-29.23|Standard Error of the Mean|10.793|||2-Sided|90.0|-47.33|-11.13||||||PF-04965842 400 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626483|NCT02201524|2987085|Superiority or Other||LS mean difference|-10.07|Standard Error of the Mean|11.013|||2-Sided|90.0|-28.53|8.39||||||PF-04965842 200 mg vs Placebo at Week 3: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626484|NCT02201524|2987085|Superiority or Other||LS mean difference|-27.07|Standard Error of the Mean|10.646|||2-Sided|90.0|-44.9|-9.23||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626485|NCT02201524|2987085|Superiority or Other||LS mean difference|-18.04|Standard Error of the Mean|10.273|||2-Sided|90.0|-35.25|-0.82||||||PF-04965842 400 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626486|NCT02201524|2987085|Superiority or Other||LS mean difference|-4.3|Standard Error of the Mean|10.387|||2-Sided|90.0|-21.71|13.11||||||PF-04965842 200 mg vs Placebo at Week 2: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626487|NCT02201524|2987085|Superiority or Other||LS mean difference|-19.22|Standard Error of the Mean|8.504|||2-Sided|90.0|-33.45|-4.99||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626488|NCT02201524|2987085|Superiority or Other||LS mean difference|-11.19|Standard Error of the Mean|8.177|||2-Sided|90.0|-24.87|2.5||||||PF-04965842 400 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626489|NCT02201524|2987085|Superiority or Other||LS mean difference|-9.32|Standard Error of the Mean|8.291|||2-Sided|90.0|-23.19|4.56||||||PF-04965842 200 mg vs Placebo at Week 1: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626490|NCT02201524|2987086|Superiority or Other||LS mean difference|-9.98|Standard Error of the Mean|2.506|||2-Sided|90.0|-14.19|-5.77||||||PF-04965842 200 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626491|NCT02201524|2987086|Superiority or Other||LS mean difference|-5.61|Standard Error of the Mean|2.375|||2-Sided|90.0|-9.61|-1.62||||||PF-04965842 400 mg vs Placebo: LANCOVA model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626492|NCT02201524|2987086|Superiority or Other||Least square (LS) mean difference|-5.08|Standard Error of the Mean|2.42|||2-Sided|90.0|-9.15|-1.01||||||PF-04965842 200 mg vs Placebo: Longitudinal analysis of covariance (LANCOVA) model contains fixed factors of treatment, week, treatment by week interaction, baseline value and unstructured covariance matrix.|
1626493|NCT02201277|2987116|Equivalence|rate of penetration||||||1|||||||t-test, 1 sided||||
1626494|NCT02201277|2987116|Superiority|||||||1|||||||t-test, 2 sided|||A Fisher’s exact test was used to determine if there was a difference in the numbers of filters with penetration for each type. The numbers were not powered enough to make extensive tests in this area meaningful.|
1626495|NCT02200770|2987134|Superiority||Rate Ratio|0.286||||0.01|2-Sided|95.0|0.1105|0.7411|||Negative Binomial Regression||||
1626496|NCT02200770|2987135|Superiority||Rate Ratio|0.566||||0.0034|2-Sided|95.0|0.3866|0.8279|||Negative Binomial Regression||||
1626497|NCT02200770|2987136|Superiority||Mean Difference (Net)|0.134|Standard Error of the Mean|1.096||0.9026|2-Sided|95.0|-2.0254|2.2941|||ANCOVA||||
1626498|NCT02200770|2987137|Superiority||Odds Ratio (OR)|0.37||||0.0049|2-Sided|95.0|0.185|0.7389|||Regression, Logistic||||
1626499|NCT02200770|2987138|Superiority||Hazard Ratio (HR)|0.272|||<|0.0001|2-Sided|95.0|0.1496|0.4961|||Regression, Cox||||
1626500|NCT02200614|2987139|Superiority||Hazard Ratio (HR)|0.428||||0.011262|2-Sided|95.0|0.218|0.842|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. > 6 months) and use of osteoclast-targeted therapy (No, Yes).||
1626501|NCT02200614|2987140|Superiority||Hazard Ratio (HR)|0.433|||<|1e-06|2-Sided|95.0|0.314|0.595|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. > 6 months) and use of osteoclast-targeted therapy (No, Yes).||
1626502|NCT02200614|2987141|Superiority||Hazard Ratio (HR)|0.647||||8e-06|2-Sided|95.0|0.533|0.785|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. > 6 months) and use of osteoclast-targeted therapy (No, Yes).||
1626503|NCT02200614|2987142|Superiority||Hazard Ratio (HR)|0.706||||0.04521|2-Sided|95.0|0.501|0.994|||Log Rank||The hazard ratio and its 95% CI were based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. > 6 months) and use of osteoclast-targeted therapy (No, Yes).||
1626504|NCT02200614|2987143|Superiority||Hazard Ratio (HR)|0.413|||<|1e-06|2-Sided|95.0|0.341|0.5|||Log Rank||Hazard ratio and 95% Confidence Interval (CI) was based on Cox Regression Model, stratified by Prostate-specific antigen doubling time (PSADT) (≤ 6 months vs. > 6 months) and use of osteoclast-targeted therapy (No, Yes).||
1626505|NCT02200510|2987146|Equivalence|Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.|Mean Difference (Final Values)|0.138||||0.721|2-Sided||||||ANOVA||||
1626506|NCT02200510|2987146|Equivalence|Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.|Mean Difference (Final Values)|0.33||||0.575|2-Sided||||||ANOVA||||
1626507|NCT02200211|2987152|Superiority||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.|
1626508|NCT02200211|2987152|Superiority||||||>|0.99|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.|
1626509|NCT02200211|2987152|Superiority||||||>|0.02|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.|
1626510|NCT02200211|2987152|Superiority||||||>|0.05|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of participants who reported diplopia (yes/no) at the 16-week visit by treatment group.|
1626511|NCT02200211|2987153|Superiority||||||>|0.99|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.|
1626512|NCT02200211|2987153|Superiority||||||>|0.99|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.|
1626513|NCT02200211|2987153|Superiority||||||>|0.48|||||||Cochran-Armitage trend test|||The frequency of diplopia, across categories of diplopia, was compared between the treatment groups using the Cochran-Armitage trend test.|
1626514|NCT02200211|2987153|Superiority||||||>|0.17|||||||Fisher Exact|||The Fisher exact test was used to compare the percentage of parents who reported that their child had experienced diplopia (yes/no) at the 16-week visit by treatment group.|
1626515|NCT02200211|2987154|Superiority|||||||0.68|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.|
1626516|NCT02200211|2987154|Superiority|||||||0.32|||||||Fisher Exact|||Fisher's exact test was used to perform the treatment group comparison of the proportion of participants who developed a new ocular deviation and/or worsening of a pre-existing ocular deviation by 10 prism diopters at the 16-week visit.|
1626517|NCT02200211|2987155|Superiority||Mean Difference (Final Values)|0.1|||||2-Sided|95.0|-1.1|1.3|||||A 95% confidence interval was computed on the treatment group difference (binocular treatment - patching) of the adjusted mean change in fellow-eye visual acuity from baseline to 16 weeks.|An analysis of covariance (ANCOVA) model was used to compute the treatment group difference in the mean change in fellow-eye visual acuity (letters) from baseline to 16 weeks, adjusting for baseline visual acuity. A 2-sided 95% confidence interval was computed on the adjusted treatment group difference.|
1626518|NCT02200211|2987156|Superiority||Mean Difference (Final Values)|0.16|||||2-Sided|95.0|0.02|0.3|||||A 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) in mean change in fellow-eye visual acuity from baseline to 16 weeks. Positive values favor the binocular treatment group.|The treatment group difference in the change in fellow-eye visual acuity from baseline to 16 weeks (logMAR lines) was evaluated in an analysis of covariance model, adjusted for baseline fellow-eye visual acuity.|
1626519|NCT02200211|2987162|Superiority|||||||0.69||||||A priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.|
1626520|NCT02200211|2987162|Superiority|||||||0.19||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.|
1626521|NCT02200211|2987163|Superiority|||||||0.83||||||A priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.|
1626522|NCT02200211|2987163|Superiority|||||||0.66||||||The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||The Wilcoxon rank-sum test was used to compare the distribution of change in stereoacuity levels from baseline to 16 weeks by treatment group.|
1626587|NCT02197130|2987358|Superiority or Other||Mean Difference (Net)|0.05|Standard Error of the Mean|0.14||0.7133|2-Sided|90.0|-0.18|0.28|||MMRM|||Week 13|
1626588|NCT02197130|2987358|Superiority or Other||Mean Difference (Net)|0.35|Standard Error of the Mean|0.148||0.0181|2-Sided|90.0|0.11|0.6|||MMRM|||Week 13|
1626523|NCT02200211|2987168|Superiority|||||||0.23||||||The a priori threshold for statistical significance of the interaction term (presence of a near heterotropia at baseline and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and presence of a near heterotropia (measured by SPCT) at baseline (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.|
1626524|NCT02200211|2987168|Superiority|||||||0.33||||||The a priori threshold for statistical significance of the interaction term (baseline stereoacuity and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline stereoacuity (nil, better than nil), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.|
1626525|NCT02200211|2987168|Superiority|||||||0.87||||||The a priori threshold for statistical significance of the interaction term (prior amblyopia treatment and treatment group) was 0.05|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and prior amblyopia treatment (Yes/No), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.|
1626526|NCT02200211|2987168|Superiority|||||||0.99||||||The a priori threshold for statistical significance of the interaction term (baseline amblyopic-eye visual acuity and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and baseline amblyopic-eye visual acuity (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline age.|
1626527|NCT02200211|2987168|Superiority|||||||0.8||||||The a priori threshold for statistical significance of the interaction term (age and treatment group) was 0.05.|ANCOVA|||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and age at baseline (treated as a continuous factor in the model), adjusting for the main effects of the interaction term and baseline visual acuity.|
1626528|NCT02200211|2987168|Superiority|||||||0.54||||||The a priori threshold for statistical significance of the interaction term (race/ethnicity status and treatment group) was 0.05.|ANCOVA|Four participants (1 binocular treatment group, 3 patching group) were excluded from the analysis due to unknown/not reported race/ethnicity status.||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and race/ethnicity status (White/non-Hispanic, Non-White or Hispanic), adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.|
1626529|NCT02200211|2987168|Superiority|||||||0.83||||||The a priori threshold for statistical significance of the interaction term (gender and treatment group) was 0.05.|ANCOVA|Previously described in the Statistical Analysis Overview.||Exploratory subgroup analyses were conducted to assess the treatment effect according to subgroups of baseline factors. An analysis of covariance was used to test the interaction between treatment group and gender, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity.|
1626530|NCT02200211|2987169|Superiority|||||||0.83||||||For testing the interaction term, the a priori threshold for statistical significance was 0.05.|ANCOVA|Previously described above in the Statistical Analysis Overview section.||A linear mixed model was used to compare the rate of amblyopic-eye visual acuity improvement between the treatment groups. The ANCOVA model included an interaction term with treatment group and time to compare the change in visual acuity over follow-up by treatment group, adjusting for the main effects of the interaction term and baseline covariates of age and visual acuity. If the interaction term was not statistically significant (p>0.05), no further comparisons would be performed.|
1626531|NCT02200211|2987170|Superiority||Risk Difference (RD)|2.0|||||2-Sided|95.0|-1.0|5.0|||||Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as having amblyopia resolution at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to <7, 7 to <13 years) and baseline visual acuity (20/40, 20/50 or worse).|
1626532|NCT02200211|2987171|Superiority||Risk Difference (RD)|-15.0|||||2-Sided|95.0|-31.0|2.0|||||Binomial regression was used to compare the group proportions (binocular treatment - patching) of participants classified as improving 2 or more logMAR lines (≥ 10 letters) from baseline at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline visual acuity.|
1626533|NCT02200211|2987171|Superiority||Risk Difference (RD)|5.0|||||2-Sided|95.0|-4.0|13.0|||||Binomial regression was used to compare the group proportions (patching - binocular treatment) of participants classified as improving 2 or more logMAR lines from baseline at the 16-week visit.|Binomial regression was used for the treatment group comparison of the proportion of participants classified as improving 2 or more logMAR lines (10 or more letters if E-ETDRS) from baseline at the 16-week visit, adjusting for baseline age group (5 to <7, 7 to <13 years) and baseline visual acuity (treated as a continuous covariate).|
1626534|NCT02200211|2987175|Superiority||Mean Difference (Final Values)|-2.6|||||2-Sided|95.0|-5.7|0.4|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to <20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but included prior amblyopia treatment as an adjustment covariate (in addition to baseline visual acuity) in the model.|
1626589|NCT02197130|2987360|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|0.46||0.8233|2-Sided|90.0|-0.66|0.86|||MMRM|||Week 26|
1626706|NCT02194933|2987786|Superiority or Other|||||||0.1873|||||||Mixed Models Analysis||||
1626535|NCT02200211|2987175|Superiority||Mean Difference (Final Values)|-2.5|||||2-Sided|95.0|-5.5|0.5|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|An ANCOVA model was fit to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to <20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this post hoc sensitivity analyses, the primary analysis was repeated but included data from participants who completed the 16-week visit outside the analysis window (n=2, range:14 to 28 weeks post randomization).|
1626536|NCT02200211|2987175|Superiority||Mean Difference (Final Values)|-1.9|||||2-Sided|95.0|-5.0|1.2|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=3) or completed the 16-week exam outside of the pre-specified analysis window (n=2).|
1626537|NCT02200211|2987175|Superiority||Mean Difference (Final Values)|-2.8|||||2-Sided|95.0|-5.9|0.3|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks (14 to <20 week window) for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants later found to be ineligible for the study (n=2).|
1626538|NCT02200211|2987175|Superiority||Mean Difference (Final Values)|-2.7|||||2-Sided|95.0|-5.9|0.5|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the change in amblyopic-eye visual acuity from baseline to 16 weeks for two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. For this sensitivity analyses, the primary analysis was repeated but excluded data from participants who completed the 16-week visit outside of the pre-specified 16 +/- 1 week protocol window (n=10 participants).|
1626539|NCT02200211|2987175|Superiority||Mean Difference (Final Values)|-2.7||||0.082|2-Sided|95.0|-5.7|0.3||a priori threshold for statistical significance: 2-sided type I error rate of 5%|ANCOVA|Adjusted for baseline amblyopic-eye visual acuity.|A 2-sided 95% confidence interval was computed on the adjusted treatment group difference (binocular treatment - patching) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit.|A modified intent-to-treat analysis was performed using an ANCOVA model to compare the effectiveness of two treatments (2-sided hypothesis test), adjusting for baseline visual acuity. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to <20 week window). A 2-sided 95% confidence interval (CI) was computed on the adjusted treatment group difference at 16 weeks. There was no imputation for missing data.|
1626540|NCT02200211|2987177|Superiority||Mean Difference (Final Values)|0.31|||||2-Sided|95.0|0.04|0.58|||||A 2-sided 95% confidence interval was computed on the adjusted treatment group difference evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive estimate values favor the patching treatment group.|Analysis of covariance included baseline age and visual acuity as adjustment covariates. The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to <20 week window). For this post hoc analysis, a 2-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis.|
1626541|NCT02200211|2987177|Non-Inferiority|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.33|||||1-Sided|95.0||0.55|||||A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye visual acuity from baseline to 16 week, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from participants who received alternative treatment for at least 1 week during study follow-up (n=4).|
1626542|NCT02200211|2987177|Non-Inferiority|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.3|||||1-Sided|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16-weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, we excluded 16-week outcomes from enrolled participants who were subsequently found to be ineligible for the study (n=7).|
1626543|NCT02200211|2987177|Non-Inferiority|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.33|||||1-Sided|95.0||0.56|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates for age and visual acuity. For this post hoc sensitivity analysis, all participants with 16-week exams were included in the analysis regardless of whether or not the exam was completed within the pre-specified analysis window (14 to <20 weeks after randomization).|
1626707|NCT02194933|2987786|Superiority or Other|||||||0.1642|||||||Mixed Models Analysis||||
1626544|NCT02200211|2987177|Non-Inferiority|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.31|||||1-Sided|95.0||0.54|||||A 1-sided 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, multiple imputation was used to impute 16-week visual acuity scores for participants who missed the exam (n=15) or completed the 16-week exam outside of the pre-specified analysis window (n=7).|
1626545|NCT02200211|2987177|Non-Inferiority|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior PEDIG studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.3|||||1-Sided|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary analysis was repeated for the treatment group comparison of change in amblyopic-eye VA from baseline to 16 weeks, adjusting for baseline covariates of age and visual acuity. For this sensitivity analysis, the primary analysis repeated but excluded data from participants (n=35) who completed the 16-week visit outside of the pre-defined protocol window (16 +/- 1 week).|
1626546|NCT02200211|2987177|Non-Inferiority|Our sample size was computed to have 90% power with a type I error of 5% for a non-inferiority limit of 0.05 logMAR (0.5 lines), assuming a standard deviation of change of 0.15 logMAR (1.5 lines) based on prior Pediatric Eye Disease Investigator Group (PEDIG) studies, and no more than 10% loss to follow-up.|Mean Difference (Final Values)|0.31|||||1-Sided|95.0||0.53|||||A 1-sided upper 95% confidence interval was computed on the adjusted group difference (patching - binocular treatment) evaluating change in amblyopic-eye visual acuity from baseline to the 16-week visit. Positive values favor the patching group.|The primary outcome measure was change in amblyopic-eye VA from baseline to 16 weeks (14 to <20 week window). The upper limit of a 1-sided 95% confidence interval (CI) was computed on the treatment group difference, using an analysis of covariance (ANCOVA) model, adjusted for baseline age and VA, including only participants completing the 16-week outcome in a modified intent-to-treat analysis. There was no imputation for missing data.|
1626547|NCT02200055|2987183|Superiority or Other|This measurement was collected for each participant. A pre-operative and post-operative bioimpedance measurement was taken.|Mean Difference (Final Values)|0.53|||<|0.01|2-Sided||||||Chi-squared||||
1626548|NCT02199717|2987203|Superiority or Other||Mean Difference (Final Values)|306.4|||<|0.01|2-Sided|95.0|254.8|358.0|||Wilcoxon (Mann-Whitney)||||
1626549|NCT02199717|2987204|Superiority or Other|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups (mild/moderate versus severe haemophilia) were examined in exploratory analyses.|
1626550|NCT02198651|2987277|Other|||||||0.688|||||||Wald Chi||||
1626551|NCT02198651|2987278|Other|||||||0.592|||||||Wald Chi||||
1626552|NCT02198651|2987279|Other|||||||0.943|||||||Wald Chi||||
1626553|NCT02197767|2987296|Superiority|||||||0.068|||||||t-test, 2 sided||||
1626554|NCT02197767|2987297|Superiority|||||||0.072|||||||t-test, 2 sided||||
1626555|NCT02197572|2987311|Other||Least Squares Mean|2.8|||||1-Sided|95.0||8.1||||||Change from Baseline at 48 Hours Postdose|
1626556|NCT02197572|2987311|Other||Least Squares Mean|7.1|||||1-Sided|95.0||11.4||||||Change from Baseline at 24 Hours Postdose|
1626557|NCT02197572|2987311|Other||Least Squares Mean|-6.6|||||1-Sided|95.0||-0.5||||||Change from Baseline at 10 Hours Postdose|
1626558|NCT02197572|2987311|Other||Least Squares Mean|-2.2|||||1-Sided|95.0||2.4||||||Change from Baseline at 8 Hours Postdose|
1626559|NCT02197572|2987311|Other||Least Squares Mean|-8.8|||||1-Sided|95.0||-4.6||||||Change from Baseline at 6 Hours Postdose|
1626560|NCT02197572|2987311|Other||Least Squares Mean|-7.2|||||1-Sided|95.0||-2.9||||||Change from Baseline at 4 Hours Postdose|
1626561|NCT02197572|2987311|Other||Least Squares Mean|-9.1|||||1-Sided|95.0||-4.6||||||Change from Baseline at 3 Hours Postdose|
1626562|NCT02197572|2987311|Other||Least Squares Mean|-7.6|||||1-Sided|95.0||-3.2||||||Change from Baseline at 2.5 Hours Postdose|
1626563|NCT02197572|2987311|Other||Least Squares Mean|-5.0|||||1-Sided|95.0||-0.6||||||Change from Baseline at 2 Hours Postdose|
1626564|NCT02197572|2987311|Other||Least Squares Mean|-2.7|||||1-Sided|95.0||1.7||||||Change from Baseline at 1.5 Hours Postdose|
1626565|NCT02197572|2987311|Other||Least Squares Mean|-1.8|||||1-Sided|95.0||2.6||||||Change from Baseline at 1 Hour Postdose|
1626566|NCT02197572|2987311|Other||Least Squares Mean|-8.3|||||1-Sided|95.0||-4.0||||||Change from Baseline at 0.5 Hours Postdose|
1626567|NCT02197572|2987311|Other||Least Squares Mean|-2.2|||||1-Sided|95.0||2.2||||||Change from Baseline at 0.25 Hours Postdose|
1626568|NCT02197273|2987330|Superiority or Other||Fisher exact|0.486||||0.656|2-Sided||||||Fisher Exact||||
1626569|NCT02197273|2987331|Superiority or Other|||||||0.206|||||||Wilcoxon (Mann-Whitney)||||
1626570|NCT02197273|2987332|Superiority or Other|||||||0.764|||||||Wilcoxon (Mann-Whitney)||||
1626571|NCT02197247|2987342|Superiority or Other (legacy)||Geometric LS Mean Ratio|100.76|||||2-Sided|90.0|92.15|110.19|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.|
1626590|NCT02197130|2987360|Superiority or Other||Mean Difference (Net)|1.21|Standard Error of the Mean|0.492||0.0149|2-Sided|90.0|0.39|2.02|||MMRM|||Week 26|
1626591|NCT02197130|2987360|Superiority or Other||Mean Difference (Net)|0.36|Standard Error of the Mean|0.491||0.4656|2-Sided|90.0|-0.45|1.17|||MMRM|||Week 13|
1626572|NCT02197247|2987342|Superiority or Other (legacy)||Geometric LS Mean Ratio|129.81|||||2-Sided|90.0|119.14|141.44|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.|
1626573|NCT02197247|2987343|Superiority or Other (legacy)||Geometric LS Mean Ratio|90.08|||||2-Sided|90.0|79.34|102.27|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.|
1626574|NCT02197247|2987343|Superiority or Other (legacy)||Geometric LS Mean Ratio|18.76|||||2-Sided|90.0|16.61|21.19|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.|
1626575|NCT02197247|2987344|Superiority or Other (legacy)||Geometric LS Mean Ratio|95.89|||||2-Sided|90.0|86.37|106.45|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for AZD9291 alone in separate periods, but analysed for consistency with AZD9291+rifampicin / AZD9291 alone analysis (primary outcome measure).|Natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.|
1626576|NCT02197247|2987346|Superiority or Other (legacy)||Geometric LS Mean Ratio|100.75|||||2-Sided|90.0|92.04|110.29|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.|
1626577|NCT02197247|2987346|Superiority or Other (legacy)||Geometric LS Mean Ratio|139.32|||||2-Sided|90.0|127.74|151.96|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ7550 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.|
1626578|NCT02197247|2987347|Superiority or Other (legacy)||Geometric LS Mean Ratio|88.31|||||2-Sided|90.0|77.17|101.07|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.|
1626579|NCT02197247|2987347|Superiority or Other (legacy)||Geometric LS Mean Ratio|21.72|||||2-Sided|90.0|19.08|24.72|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1). No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|For AZ5104 (metabolite), natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.|
1626580|NCT02197247|2987348|Superiority or Other (legacy)||Geometric LS Mean Ratio|95.53|||||2-Sided|90.0|85.27|107.03|||||AZD9291 alone / AZD9291 alone (Period 3 versus Period 1). No pre-specified margins for equivalence test for AZD9291 alone in separate periods, but analysed for consistency with AZD9291+rifampicin / AZD9291 alone analysis (primary outcome measure).|Natural log-transformed Css,max values were compared between periods using a mixed effects ANOVA with period as a fixed effect and patient as a random effect.|
1626581|NCT02197247|2987349|Non-Inferiority or Equivalence (legacy)|No effect on the PK of AZD9291 after co-administration of rifampicin was concluded if the lower bound of the 90% CIs for the ratios (Period 2 versus Period 1) of AZD9291 AUCtau and Css,max were both above 50%. The experiment-wide power for the ratios being above 50% was 90% (95% power for each parameter).|Geometric LS Mean Ratio|21.55|||||2-Sided|90.0|19.5|23.83|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1).|Natural log-transformed AUCtau values were compared between periods using a mixed effects ANOVA with period as fixed effect and patient as random effect. It was assumed the within-patient coefficient of variation for AZD9291 in both AUCtau and Cmax was 34%. A 33% decrease in exposure for AZD9291 when given with rifampicin was also assumed.|
1626582|NCT02197247|2987350|Non-Inferiority or Equivalence (legacy)|No effect on the PK of AZD9291 after co-administration of rifampicin was concluded if the lower bound of the 90% confidence intervals (CIs) for the ratios (Period 2 versus Period 1) of AZD9291 AUCtau and Css,max were both above 50%. The experiment-wide power for the ratios being above 50% was 90% (95% power for each parameter).|Geometric least-squares (LS) mean ratio|27.16|||||2-Sided|90.0|24.36|30.29|||||AZD9291+rifampicin / AZD9291 alone (Period 2 versus Period 1).|Natural log-transformed Css,max values were compared between periods using a mixed effects analysis of variance (ANOVA) with period as fixed effect and patient as random effect. It was assumed the within-patient coefficient of variation for AZD9291 in both area under the plasma concentration-time curve during the dosing interval (AUCtau) and Cmax was 34%. A 33% decrease in exposure for AZD9291 when given with rifampicin was also assumed.|
1626583|NCT02197234|2987356|Non-Inferiority or Equivalence (legacy)|90% CIs being within 70% to 143%.|Geometric mean ratio|91.46|||||2-Sided|90.0|77.16|108.41|||||Simvastatin + AZD9291 / Simvastatin alone. Based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AUC9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 45%. No change in exposure was also assumed.|
1626584|NCT02197234|2987357|Non-Inferiority or Equivalence (legacy)|90% CIs being within 70% to 143%.|Geometric mean ratio|77.08|||||2-Sided|90.0|63.41|93.7|||||Simvastatin + AZD9291 / Simvastatin alone. Based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AUC9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 45%. No change in exposure was also assumed.|
1626585|NCT02197130|2987358|Superiority or Other||Mean Difference (Net)|0.03|Standard Error of the Mean|0.15||0.8339|2-Sided|90.0|-0.22|0.28|||MMRM|||Week 26|
1626594|NCT02197130|2987372|Superiority or Other||Mean Difference (Net)|1.52|Standard Error of the Mean|1.192||0.2033|2-Sided|90.0|-0.45|3.49|||MMRM|MMRM: A linear mixed‑effect repeated measures model|||
1626595|NCT02197078|2987373|Other||Hazard Ratio (HR)|1.65|||||2-Sided|95.0|0.64|4.27|||||||
1626596|NCT02197078|2987373|Other||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.38|2.43|||||||
1626597|NCT02197078|2987373|Other||Hazard Ratio (HR)|1.17|||||2-Sided|95.0|0.57|2.4|||||||
1626598|NCT02197078|2987373|Other||Hazard Ratio (HR)|1.84|||||2-Sided|95.0|0.62|5.48|||||||
1626599|NCT02197078|2987373|Other||Hazard Ratio (HR)|1.67|||||2-Sided|95.0|0.61|4.58|||||||
1626600|NCT02197078|2987373|Other||Hazard Ratio (HR)|1.62|||||2-Sided|95.0|0.64|4.06|||||||
1626601|NCT02197078|2987374|Other||Hazard Ratio (HR)|0.91|||||2-Sided|95.0|0.75|1.09|||||||
1626602|NCT02197078|2987374|Other||Hazard Ratio (HR)|1.07|||||2-Sided|95.0|0.9|1.27|||||||
1626603|NCT02197078|2987374|Other||Hazard Ratio (HR)|1.04|||||2-Sided|95.0|0.91|1.19|||||||
1626604|NCT02197078|2987374|Other||Hazard Ratio (HR)|1.04|||||2-Sided|95.0|0.84|1.29|||||||
1626605|NCT02197078|2987374|Other||Hazard Ratio (HR)|1.31|||||2-Sided|95.0|1.06|1.61|||||||
1626606|NCT02197078|2987374|Other||Hazard Ratio (HR)|1.24|||||2-Sided|95.0|1.04|1.47|||||||
1626607|NCT02197078|2987375|Other||Hazard Ratio (HR)|1.17|||||2-Sided|95.0|0.81|1.71|||||||
1626608|NCT02197078|2987375|Other||Hazard Ratio (HR)|1.52|||||2-Sided|95.0|1.02|2.27|||||||
1626609|NCT02197078|2987375|Other||Hazard Ratio (HR)|1.34|||||2-Sided|95.0|1.01|1.76|||||||
1626610|NCT02197078|2987375|Other||Hazard Ratio (HR)|1.16|||||2-Sided|95.0|0.75|1.79|||||||
1626611|NCT02197078|2987375|Other||Hazard Ratio (HR)|1.71|||||2-Sided|95.0|1.07|2.72|||||||
1626612|NCT02197078|2987375|Other||Hazard Ratio (HR)|1.4|||||2-Sided|95.0|0.97|2.0|||||||
1626613|NCT02197078|2987376|Other||Hazard Ratio (HR)|0.79|||||2-Sided|95.0|0.54|1.14|||||||
1626614|NCT02197078|2987376|Other||Hazard Ratio (HR)|1.1|||||2-Sided|95.0|0.77|1.56|||||||
1626615|NCT02197078|2987376|Other||Hazard Ratio (HR)|0.99|||||2-Sided|95.0|0.76|1.29|||||||
1626616|NCT02197078|2987376|Other||Hazard Ratio (HR)|1.11|||||2-Sided|95.0|0.73|1.68|||||||
1626617|NCT02197078|2987376|Other||Hazard Ratio (HR)|1.9|||||2-Sided|95.0|1.19|3.03|||||||
1626618|NCT02197078|2987376|Other||Hazard Ratio (HR)|1.55|||||2-Sided|95.0|1.1|2.18|||||||
1626619|NCT02197078|2987377|Other||Hazard Ratio (HR)|0.74|||||2-Sided|95.0|0.52|1.05|||||||
1626620|NCT02197078|2987377|Other||Hazard Ratio (HR)|1.09|||||2-Sided|95.0|0.78|1.52|||||||
1626621|NCT02197078|2987377|Other||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.73|1.25|||||||
1626622|NCT02197078|2987377|Other||Hazard Ratio (HR)|0.44|||||2-Sided|95.0|0.24|0.78|||||||
1626623|NCT02197078|2987377|Other||Hazard Ratio (HR)|0.99|||||2-Sided|95.0|0.6|1.64|||||||
1626624|NCT02197078|2987377|Other||Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.58|1.38|||||||
1626625|NCT02197078|2987378|Other||Hazard Ratio (HR)|0.76|||||2-Sided|95.0|0.6|0.97|||||||
1626626|NCT02197078|2987378|Other||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.77|1.19|||||||
1626627|NCT02197078|2987378|Other||Hazard Ratio (HR)|0.97|||||2-Sided|95.0|0.81|1.17|||||||
1626628|NCT02197078|2987378|Other||Hazard Ratio (HR)|0.6|||||2-Sided|95.0|0.41|0.88|||||||
1626629|NCT02197078|2987378|Other||Hazard Ratio (HR)|0.63|||||2-Sided|95.0|0.44|0.9|||||||
1626630|NCT02197078|2987378|Other||Hazard Ratio (HR)|0.69|||||2-Sided|95.0|0.51|0.94|||||||
1626631|NCT02197078|2987379|Other||Hazard Ratio (HR)|0.81|||||2-Sided|95.0|0.62|1.06|||||||
1626632|NCT02197078|2987379|Other||Hazard Ratio (HR)|1.01|||||2-Sided|95.0|0.79|1.28|||||||
1626633|NCT02197078|2987379|Other||Hazard Ratio (HR)|1.04|||||2-Sided|95.0|0.85|1.28|||||||
1626634|NCT02197078|2987379|Other||Hazard Ratio (HR)|0.7|||||2-Sided|95.0|0.48|1.01|||||||
1626635|NCT02197078|2987379|Other||Hazard Ratio (HR)|0.81|||||2-Sided|95.0|0.57|1.16|||||||
1626636|NCT02197078|2987379|Other||Hazard Ratio (HR)|0.9|||||2-Sided|95.0|0.66|1.23|||||||
1626637|NCT02197078|2987380|Other||Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.66|0.96|||||||
1626638|NCT02197078|2987380|Other||Hazard Ratio (HR)|1.01|||||2-Sided|95.0|0.85|1.19|||||||
1626639|NCT02197078|2987380|Other||Hazard Ratio (HR)|0.95|||||2-Sided|95.0|0.83|1.1|||||||
1626640|NCT02197078|2987380|Other||Hazard Ratio (HR)|0.65|||||2-Sided|95.0|0.49|0.86|||||||
1626641|NCT02197078|2987380|Other||Hazard Ratio (HR)|0.85|||||2-Sided|95.0|0.65|1.1|||||||
1626642|NCT02197078|2987380|Other||Hazard Ratio (HR)|0.82|||||2-Sided|95.0|0.66|1.03|||||||
1626643|NCT02197065|2987381|Superiority||Median Difference (Final Values)|0.3||||1|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1626644|NCT02197065|2987382|Superiority||Median Difference (Final Values)|13.0||||0.58|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1626645|NCT02197065|2987383|Other||Proportion|0.2|||||1-Sided|||||||||This was a pilot feasibility study and we were only powered to determine the frequency of troponin elevation in the entire study population, not to compare the frequency of a rise in troponin in the two study arms. Thus Aim 1 applies to the entire study cohort.|
1626646|NCT02196506|2987465|Superiority||Mean Difference (Final Values)|-2.98||||0.0099|2-Sided|95.0|-5.24|-0.72|||Mixed Models Analysis|||Statistical Analysis at Week 14|
1626647|NCT02196506|2987466|Superiority||Mean Difference (Final Values)|-2.25||||0.0263|2-Sided|95.0|-4.23|-0.27|||Mixed Models Analysis|||Statistical Analysis at Week 14|
1626648|NCT02196506|2987467|Superiority||Mean Difference (Final Values)|-0.22||||0.3331|2-Sided|95.0|-0.66|0.23|||Mixed Models Analysis|||Statistical Analysis at Week 14|
1626649|NCT02196506|2987468|Superiority||Mean Difference (Final Values)|-2.3||||0.0074|2-Sided|95.0|-3.97|-0.62|||Mixed Models Analysis|||Statistical Analysis at Week 14|
1626665|NCT02195583|2987520|Superiority or Other||Mean Difference (Net)|4.25|||<|0.0013|2-Sided|95.0|1.68|6.82|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).||
1626650|NCT02195986|2987485|Superiority|Superiority test of reference product vs placebo|Difference|0.1196||||0.1805|2-Sided|95.0|-0.0491|0.2883|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p<0.05, two-sided) using the Chi squared test with Yate's correction for the secondary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP > 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.|
1626651|NCT02195986|2987485|Superiority|Superiority test of test product vs placebo|Difference|0.1387||||0.1092|2-Sided|95.0|-0.028|0.3054|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p<0.05, two-sided) using the Chi squared test with Yate's correction for the secondary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP > 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.|
1626652|NCT02195986|2987486|Equivalence|Bioequivalence was established for the secondary endpoint if the 90% confidence interval for the difference of responder rates (test - reference) from baseline to Day 8 for the secondary endpoint is contained within [-0.20, 0.20], using the per-protocol population.|Difference|0.05|||||2-Sided|90.0|-0.0687|0.1686|||||||
1626653|NCT02195986|2987487|Superiority|Superiority test of reference product vs placebo|Difference|0.3542|||<|0.0001|2-Sided|95.0|0.257|0.4514|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p<0.05, two-sided) using the Chi squared test with Yate's correction for the primary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP > 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.|
1626654|NCT02195986|2987487|Superiority|Superiority test of test product vs placebo|Difference|0.3766|||<|0.0001|2-Sided|95.0|0.2743|0.479|||Chi-squared|||Both the test and reference products should both be statistically superior to placebo (p<0.05, two-sided) using the Chi squared test with Yate's correction for the primary endpoint responder rate, using the ITT study population and last observation carried forward. The compound hypothesis to test was: H0: PT - PP ≤ 0 versus HA: PT - PP > 0; Where PT = cure rate of test treatment, and PP = cure rate of placebo.|
1626655|NCT02195986|2987488|Equivalence|Bioequivalence was established for the primary endpoint if the 90% confidence interval for the difference of responder rates (test – reference) from baseline to Day 8 for the primary endpoint is contained within [-0.20, 0.20], using the per-protocol population.|Difference|-0.0062|||||2-Sided|90.0|-0.1209|0.1084||||||The compound hypothesis to test was: H0: PT –PR < -.20 or PT –PR > .20 versus HA : -.20 ≤ PT –PR ≤ .20 Where PT = cure rate of test treatment, and PR = cure rate of reference treatment.|
1626656|NCT02195700|2987508|Superiority||Differences in %|7.9||||0.4001|2-Sided|95.0|-10.2|25.2||5% level of significance (2-sided)|Pearson's chi-square test|||The secondary efficacy endpoints were analyzed using a hierarchical testing procedure. If the primary analysis was statistically significant (p<0.05), then the first key secondary endpoint was to be analyzed. If the first key secondary endpoint was statistically significant, then the second key secondary endpoint was to be similarly analyzed. For any analysis that was not statistically significant, all subsequent analyses of key secondary endpoints were exploratory rather than confirmatory.|
1626657|NCT02195700|2987509|Superiority||LSM difference|-1.4|Standard Error of the Mean|0.6||0.0188|2-Sided|95.0|-2.6|-0.2||5% level of significance (2-sided)|unstructured covariance|||The linear mixed model for repeated measurements (MMRM) included fixed effects for treatment, each scheduled time point (5 levels: weeks 2, 4, 6, 9, and 12), the treatment-by-time point interaction, and the DRA status. Baseline AIMS score was a covariate. The unstructured covariance model was used, and the primary analysis compared the SD-809 and placebo groups at week 12. This was based on the F-test using the Satterhwaite method to compute the denominator degrees of freedom.|
1626658|NCT02195583|2987520|Superiority or Other||Mean Difference (Net)|9.26|||<|0.0001|2-Sided|95.0|6.77|11.75|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426ppm) + zinc base B' such that a positive difference favors Sodium fluoride (1426 ppm).||
1626659|NCT02195583|2987520|Superiority or Other||Mean Difference (Net)|9.87|||<|0.0001|2-Sided|95.0|7.36|12.37|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus 'Sodium fluoride (1426 ppm) + zinc base A' such that a positive difference favors Sodium fluoride (1426 ppm).||
1626660|NCT02195583|2987520|Superiority or Other||Mean Difference (Net)|-1.56|||<|0.2185|2-Sided|95.0|-4.04|0.93|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base B' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base B'.||
1626661|NCT02195583|2987520|Superiority or Other||Mean Difference (Net)|-2.16|||<|0.092|2-Sided|95.0|-4.67|0.35|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as 'Sodium fluoride (1426 ppm) + zinc base A' minus Sodium fluoride (0 ppm) such that a positive difference favors 'Sodium fluoride (1426 ppm) + zinc base A'.||
1626662|NCT02195583|2987520|Superiority or Other||Mean Difference (Net)|2.78|||<|0.0325|2-Sided|95.0|0.23|5.32|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (250 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (250 ppm).||
1626663|NCT02195583|2987520|Superiority or Other||Mean Difference (Net)|7.03|||<|0.0001|2-Sided|95.0|4.51|9.55|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1150 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1150 ppm).||
1626664|NCT02195583|2987520|Superiority or Other||Mean Difference (Net)|7.71|||<|0.0001|2-Sided|95.0|5.2|10.21|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (0 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).||
1626690|NCT02194933|2987774|Superiority or Other|||||||0.0588|||||||Mixed Models Analysis||||
1626666|NCT02195583|2987520|Superiority or Other||Mean Difference (Net)|4.93|||<|0.0002|2-Sided|95.0|2.38|7.48|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (250 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).||
1626667|NCT02195583|2987520|Superiority or Other||Mean Difference (Net)|0.68|||<|0.595|2-Sided|95.0|-1.84|3.2|||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.|Difference was calculated as Sodium fluoride (1426 ppm) minus Sodium fluoride (1150 ppm) such that a positive difference favors Sodium fluoride (1426 ppm).||
1626668|NCT02195583|2987520|Superiority or Other||||||<|0.2274|||||||ANOVA|Calculated from ANOVA model using treatment and study period as fixed factors and participant as random effect.||Quadratic contrasts were fitted in order to establish whether there was a dose-response relationship. Quadratic contrasts are for experimental dentifrice: non-zinc treatments.|
1626669|NCT02195583|2987520|Superiority or Other||||||<|0.0001|||||||ANOVA|Calculated from Analysis of Variance (ANOVA) model using treatment and study period as fixed factors and participant as random effect.||Linear contrasts were fitted in order to establish whether there was a dose-response relationship. Linear contrasts were for experimental dentifrice: non-zinc treatments.|
1626670|NCT02195427|2987575|Non-Inferiority|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA Deep Lines and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.1|||||2-Sided|97.5|-0.25|0.06|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 97.5% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Deep Lines versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Deep Lines compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline"|
1626671|NCT02195427|2987575|Non-Inferiority|"A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.~The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA Global Action and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline)."|Mean Difference (Final Values)|-0.03|||||2-Sided|97.5|-0.17|0.11|||||The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 97.5% CI must be ≤0.5|"Efficacy of TEOSYAL® RHA Global Action versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.~The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline."|
1626672|NCT02195310|2987745|Superiority|||||||0.7007|||||||Fisher Exact Test (2-sided)||||
1626673|NCT02195232|2987748|Other|||||||0.92|||||||t-test, 2 sided||||
1626674|NCT02194998|2987753|Superiority|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.24||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort D's SVR24 rate <= 70%.|
1626675|NCT02194998|2987753|Superiority|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort C's SVR24 rate <= 70%.|
1626676|NCT02194998|2987753|Superiority|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.47||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort B's SVR24 rate <= 70%.|
1626677|NCT02194998|2987753|Superiority|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort A's SVR24 rate <= 70%.|
1626678|NCT02194998|2987766|Superiority|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.||||||0.24||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort D's SVR12 rate <= 70%.|
1626679|NCT02194998|2987766|Superiority|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort C's SVR12 rate <= 70%.|
1626680|NCT02194998|2987766|Superiority|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.47||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort B's SVR12 rate <= 70%.|
1626681|NCT02194998|2987766|Superiority|A one-sided exact binomial test was used against a null rate of 70% at a significance level of 5%.|||||<|0.01||||||No adjustments for multiple comparisons.|One-Sided Exact Binomial Test|||Null Hypothesis: Cohort A's SVR12 rate <= 70%.|
1626682|NCT02194933|2987770|Superiority or Other|||||||0.4272|||||||Mixed Models Analysis||||
1626683|NCT02194933|2987770|Superiority or Other|||||||0.0078|||||||Mixed Models Analysis||||
1626684|NCT02194933|2987771|Superiority or Other|||||||0.9058|||||||Mixed Models Analysis||||
1626685|NCT02194933|2987771|Superiority or Other|||||||0.6558|||||||Mixed Models Analysis||||
1626686|NCT02194933|2987772|Superiority or Other|||||||0.2336|||||||Mixed Models Analysis||||
1626687|NCT02194933|2987772|Superiority or Other|||||||0.7178|||||||Mixed Models Analysis||||
1626688|NCT02194933|2987773|Superiority or Other|||||||0.767|||||||Mixed Models Analysis||||
1626689|NCT02194933|2987773|Superiority or Other|||||||0.1666|||||||Mixed Models Analysis||||
1626708|NCT02194933|2987787|Superiority or Other|||||||0.6201|||||||Mixed Models Analysis||||
1626709|NCT02194933|2987787|Superiority or Other|||||||0.1559|||||||Mixed Models Analysis||||
1626710|NCT02194933|2987789|Superiority or Other|||||||0.0053||||||Test for Baseline vs. Week 6|Mixed Models Analysis||||
1626711|NCT02194933|2987790|Superiority or Other|||||||0.3992||||||Test for Baseline vs. Week 6|Mixed Models Analysis||||
1626712|NCT02194699|2987798|Superiority||Odds Ratio (OR)|0.91||||0.5276|2-Sided|95.0|0.69|1.21|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: FAS population; Tralo 300 mg Q2W vs placebo.|
1626713|NCT02194699|2987798|Superiority||Odds Ratio (OR)|1.05||||0.7768|2-Sided|95.0|0.75|1.46|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.|
1626714|NCT02194699|2987798|Superiority||Odds Ratio (OR)|0.77||||0.344|2-Sided|95.0|0.44|1.33|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.|
1626715|NCT02194699|2987799|Superiority||LS Mean difference|-1.19||||0.4645|2-Sided|95.0|-4.4|2.01|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in number (%) of awakenings at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.|
1626716|NCT02194699|2987799|Superiority||LS Mean difference|0.46||||0.8112|2-Sided|95.0|-3.33|4.25|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626717|NCT02194699|2987799|Superiority||LS Mean difference|-5.04||||0.1099|2-Sided|95.0|-11.21|1.14|||Repeated measures analysis||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626718|NCT02194699|2987800|Superiority||LS Mean difference|3.88||||0.4221|2-Sided|95.0|-5.6|13.37|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|Comparison of mean change from baseline in evening PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.|
1626719|NCT02194699|2987800|Superiority||LS Mean difference|3.46||||0.4764|2-Sided|95.0|-6.06|12.97|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|Comparison of mean change from baseline in morning PEF at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.|
1626720|NCT02194699|2987800|Superiority||LS Mean difference|3.59||||0.531|2-Sided|95.0|-7.65|14.83|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626721|NCT02194699|2987800|Superiority||LS Mean difference|7.84||||0.3971|2-Sided|95.0|-10.32|26.0|||Repeated measures analysis||Model included fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626722|NCT02194699|2987800|Superiority||LS Mean difference|3.02||||0.5984|2-Sided|95.0|-8.22|14.26|||Repeated measures analysis||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626793|NCT02193815|2987840|Superiority or Other||Adjusted Mean|125.62|Standard Error of the Mean|0.147||0.1318|2-Sided|95.0|92.96|169.75|||Mixed Models Analysis||||
1627831|NCT02170779|2989697|Superiority or Other|||||||0.8434|||||||Wilcoxon (Mann-Whitney)||||
1626723|NCT02194699|2987800|Superiority||LS Mean difference|6.15||||0.5094|2-Sided|95.0|-12.13|24.43|||Repeated measures analysis||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626724|NCT02194699|2987801|Superiority||LS Mean difference|-0.17||||0.4689|2-Sided|95.0|-0.63|0.29|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.|
1626725|NCT02194699|2987801|Superiority||LS Mean difference|0.15||||0.5864|2-Sided|95.0|-0.4|0.7|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626726|NCT02194699|2987801|Superiority||LS Mean difference|-0.95||||0.036|2-Sided|95.0|-1.85|-0.06|||Repeated measures analysis||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in rescue medication use at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626727|NCT02194699|2987803|Superiority||Rate ratio|0.67||||0.1155|2-Sided|95.0|0.41|1.1|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: FAS population; Tralo 300 mg Q2W vs placebo.|
1626728|NCT02194699|2987803|Superiority||Rate ratio|0.83||||0.5249|2-Sided|95.0|0.46|1.48|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|"Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."|
1626729|NCT02194699|2987803|Superiority||Rate ratio|0.39||||0.0576|2-Sided|95.0|0.15|1.03|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|"Comparison of AAER associated with an ER/UC visit or hospitalisation: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."|
1626730|NCT02194699|2987804|Superiority||LS Mean difference|-0.08||||0.2432|2-Sided|95.0|-0.21|0.05|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of change in mean score from baseline for ACQ-6 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.|
1626731|NCT02194699|2987804|Superiority||LS Mean difference|0.0||||0.9735|2-Sided|95.0|-0.16|0.16|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626732|NCT02194699|2987804|Superiority||LS Mean difference|-0.27||||0.04|2-Sided|95.0|-0.53|-0.01|||Repeated measures analysis||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626733|NCT02194699|2987805|Superiority||LS Mean difference|0.06||||0.4506|2-Sided|95.0|-0.1|0.22|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.|
1626794|NCT02193815|2987840|Superiority or Other||Adjusted Mean|96.04|Standard Error of the Mean|0.127||0.7529|2-Sided|95.0|74.0|124.64|||Mixed Models Analysis||||
1626795|NCT02193815|2987841|Superiority or Other||Adjusted Mean|71.94|Standard Error of the Mean|0.075|<|0.0001|2-Sided|95.0|62.08|83.36|||Mixed Models Analysis||||
1626734|NCT02194699|2987805|Superiority||LS Mean difference|-0.01||||0.9083|2-Sided|95.0|-0.2|0.17|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626735|NCT02194699|2987805|Superiority||LS Mean difference|0.27||||0.0874|2-Sided|95.0|-0.04|0.57|||Repeated measures analysis||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626736|NCT02194699|2987806|Superiority||LS Mean difference|-0.04||||0.5763|2-Sided|95.0|-0.18|0.1|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in total asthma symptom score at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.|
1626737|NCT02194699|2987806|Superiority||LS Mean difference|0.04||||0.6548|2-Sided|95.0|-0.13|0.2|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626738|NCT02194699|2987806|Superiority||LS Mean difference|-0.2||||0.1456|2-Sided|95.0|-0.47|0.07|||Repeated measures analysis||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis. A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626739|NCT02194699|2987807|Superiority||LS Mean difference|2.95||||0.1164|2-Sided|95.0|-0.73|6.62|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: FAS population; Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment|
1626740|NCT02194699|2987807|Superiority||LS Mean difference|3.37||||0.1276|2-Sided|95.0|-0.97|7.7|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker negative population; Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626741|NCT02194699|2987807|Superiority||Least square (LS) Mean difference|1.86||||0.6033|2-Sided|95.0|-5.16|8.88|||Repeated measures analysis||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of % change from baseline in pre-dose/pre-BD FEV1 at Week 52: Biomarker positive population; Tralo 300 mg Q2W vs placebo.~Restricted maximum likelihood (REML) based repeated measures analysis on patients with a baseline pre-dose/pre-BD FEV1 assessment.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term and a 3-way biomarker population-by-treatment-by-visit interaction term was included in the analysis model."|
1626742|NCT02194699|2987808|Superiority|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|-3.14||||0.8027|2-Sided|95.0|-31.46|19.08|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): FAS population; Tralo 300 mg Q2W vs placebo.|
1626743|NCT02194699|2987808|Superiority|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|1.03||||0.8027|2-Sided|95.0|0.81|1.31|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): FAS population; Tralo 300 mg Q2W vs placebo.|
1626796|NCT02193815|2987841|Superiority or Other||Adjusted Mean|106.51|Standard Error of the Mean|0.075|<|0.3991|2-Sided|95.0|91.92|123.41|||Mixed Models Analysis||||
1626797|NCT02193815|2987841|Superiority or Other||Adjusted Mean|149.56|Standard Error of the Mean|0.075|<|0.0001|2-Sided|95.0|129.04|173.34|||Mixed Models Analysis||||
1626798|NCT02193815|2987841|Superiority or Other||Adjusted Mean|93.04|Standard Error of the Mean|0.075|<|0.3349|2-Sided|95.0|80.3|107.81|||Mixed Models Analysis||||
1627832|NCT02170779|2989698|Superiority or Other|||||||0.738|||||||Wilcoxon (Mann-Whitney)||||
1626744|NCT02194699|2987808|Superiority|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|15.83||||0.4656|2-Sided|95.0|-33.71|47.01|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate reduction): Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."|
1626745|NCT02194699|2987808|Superiority|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|1.13||||0.4126|2-Sided|95.0|0.85|1.5|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate ratio): Biomarker negative population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."|
1626746|NCT02194699|2987808|Superiority|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.84||||0.4656|2-Sided|95.0|0.53|1.34|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|"Comparison of AAER (rate ratio): Biomarker positive population; Tralo 300 mg Q2W vs placebo.~A variable for the biomarker population (positive, negative) as well as a treatment-by-biomarker population interaction term was included in the analysis model."|
1626747|NCT02194621|2987809|Superiority or Other|||||||0.002|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1626748|NCT02194621|2987810|Superiority or Other||||||>|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1626749|NCT02194621|2987811|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1626750|NCT02194621|2987812|Superiority or Other||||||>|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1626751|NCT02193828|2987828|Superiority or Other|||||||0.3423|||||||Fisher Exact||||
1626752|NCT02193828|2987828|Superiority or Other|||||||0.0033|||||||Fisher Exact||||
1626753|NCT02193828|2987828|Superiority or Other|||||||0.0349|||||||Fisher Exact||||
1626754|NCT02193828|2987828|Superiority or Other|||||||0.0065|||||||Fisher Exact||||
1626755|NCT02193828|2987829|Superiority or Other|||||||0.3216|||||||Wilcoxon (Mann-Whitney)||||
1626756|NCT02193828|2987829|Superiority or Other|||||||0.0079|||||||Wilcoxon (Mann-Whitney)||||
1626757|NCT02193828|2987829|Superiority or Other|||||||0.0034|||||||Wilcoxon (Mann-Whitney)||||
1626758|NCT02193828|2987829|Superiority or Other|||||||0.0048|||||||Kruskal-Wallis||||
1626759|NCT02193828|2987830|Superiority or Other|||||||0.1298|||||||Wilcoxon (Mann-Whitney)||||
1626760|NCT02193828|2987830|Superiority or Other|||||||0.0012|||||||Wilcoxon (Mann-Whitney)||||
1626761|NCT02193828|2987830|Superiority or Other|||||||0.0014|||||||Wilcoxon (Mann-Whitney)||||
1626762|NCT02193828|2987830|Superiority or Other|||||||0.0006|||||||Kruskal-Wallis||||
1626763|NCT02193828|2987831|Superiority or Other|||||||0.1234|||||||ANOVA||||
1626764|NCT02193828|2987831|Superiority or Other|||||||0.1573|||||||ANOVA||||
1626765|NCT02193828|2987831|Superiority or Other|||||||0.7249|||||||ANOVA||||
1626766|NCT02193828|2987831|Superiority or Other|||||||0.3135|||||||ANOVA||||
1626767|NCT02193828|2987832|Superiority or Other|||||||0.0031|||||||ANOVA||||
1626768|NCT02193828|2987832|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1626769|NCT02193828|2987832|Superiority or Other||||||<|0.0075|||||||ANOVA||||
1626770|NCT02193828|2987832|Superiority or Other||||||<|0.0004|||||||ANOVA||||
1626771|NCT02193828|2987833|Superiority or Other|||||||0.0139|||||||Wilcoxon (Mann-Whitney)||||
1626772|NCT02193828|2987833|Superiority or Other|||||||0.0002|||||||Wilcoxon (Mann-Whitney)||||
1626773|NCT02193828|2987833|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1626774|NCT02193828|2987833|Superiority or Other||||||<|0.0002|||||||Kruskal-Wallis||||
1626775|NCT02193828|2987834|Superiority or Other|||||||0.9123|||||||ANOVA|||For volume|
1626776|NCT02193828|2987834|Superiority or Other|||||||0.7883|||||||ANOVA|||For volume|
1626777|NCT02193828|2987834|Superiority or Other|||||||0.1275|||||||ANOVA|||For volume|
1626778|NCT02193828|2987834|Superiority or Other|||||||0.3556|||||||ANOVA|||For volume|
1626779|NCT02193828|2987834|Superiority or Other|||||||0.704|||||||ANOVA|||For surface area|
1626780|NCT02193828|2987834|Superiority or Other|||||||0.3409|||||||ANOVA|||For surface area|
1626781|NCT02193828|2987834|Superiority or Other|||||||0.0625|||||||ANOVA|||For surface area|
1626782|NCT02193828|2987834|Superiority or Other|||||||0.2431|||||||ANOVA|||For surface area|
1626783|NCT02193828|2987835|Superiority or Other|||||||0.0446|||||||ANOVA|||For volume|
1626784|NCT02193828|2987835|Superiority or Other|||||||0.0001|||||||ANOVA|||For volume|
1626785|NCT02193828|2987835|Superiority or Other|||||||0.0001|||||||ANOVA|||For volume|
1626786|NCT02193828|2987835|Superiority or Other|||||||0.0002|||||||ANOVA|||For volume|
1626787|NCT02193828|2987835|Superiority or Other|||||||0.0713|||||||ANOVA|||For surface area|
1626788|NCT02193828|2987835|Superiority or Other||||||<|0.0001|||||||ANOVA|||For surface area|
1626789|NCT02193828|2987835|Superiority or Other||||||<|0.0001|||||||ANOVA|||For surface area|
1626790|NCT02193828|2987835|Superiority or Other||||||<|0.0001|||||||ANOVA|||For surface area|
1626791|NCT02193815|2987840|Superiority or Other||Adjusted Mean|81.09|Standard Error of the Mean|0.124||0.1012|2-Sided|95.0|62.94|104.47|||Mixed Models Analysis||||
1626792|NCT02193815|2987840|Superiority or Other||Adjusted Mean|103.35|Standard Error of the Mean|0.129||0.8009|2-Sided|95.0|79.3|134.68|||Mixed Models Analysis||||
1626799|NCT02193815|2987842|Superiority or Other||Adjusted Mean|65.42|Standard Error of the Mean|0.075|<|0.0001|2-Sided|95.0|56.46|75.81|||Mixed Models Analysis||||
1626800|NCT02193815|2987843|Superiority or Other||Adjusted Mean|165.88|Standard Error of the Mean|0.075|<|0.0001|2-Sided|95.0|143.12|192.25|||Mixed Models Analysis||||
1626801|NCT02193815|2987844|Superiority or Other||Adjusted Mean Ratio|93.2|Standard Error of the Mean|0.075||0.3465|2-Sided|95.0|80.43|107.99|||Mixed Models Analysis||||
1626802|NCT02193490|2987847|Other||||||<|0.001|||||||Kruskal-Wallis||||
1626803|NCT02193490|2987848|Other|||||||0.078|||||||Kruskal-Wallis||||
1626804|NCT02193490|2987849|Other|||||||0.001|||||||Kruskal-Wallis||||
1626805|NCT02193165|2987867|Superiority or Other||||||<|0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P<0.05|
1626806|NCT02193165|2987868|Superiority or Other||||||<|0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between intervention groups will be determined @ P<0.05|
1626807|NCT02193165|2987869|Superiority or Other|||||||0.816|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups. Differences will be noted at P<0.05. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different|
1626808|NCT02193165|2987870|Superiority or Other||||||<|0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups will be determined at P<0.05|
1626809|NCT02193165|2987871|Superiority or Other||||||<|0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline. Significant differences between groups determined by P<0.05|
1626810|NCT02193165|2987872|Superiority or Other|||||||0.434|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. Baseline groups are balanced and baseline scores for each intervention group should not be significantly different. Significance will be determined by p<0.5|
1626811|NCT02193087|2987883|Non-Inferiority or Equivalence|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|0.74|||||2-Sided|90.0|0.57|0.95||||||DEN-4|
1626812|NCT02193087|2987883|Non-Inferiority or Equivalence|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|1.46|||||2-Sided|90.0|1.13|1.89||||||DEN-3|
1626813|NCT02193087|2987883|Non-Inferiority or Equivalence|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|1.06|||||2-Sided|90.0|0.9|1.26||||||DEN-2|
1626814|NCT02193087|2987883|Non-Inferiority or Equivalence|Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.|LS Mean Ratio|0.29|||||2-Sided|90.0|0.23|0.36||||||DEN-1|
1626815|NCT02193074|2987890|Superiority or Other||Hazard Ratio (HR)|0.844||||0.6268|2-Sided|95.0|0.427|1.6698|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject’s disease duration at screening.|||
1626816|NCT02193074|2987890|Superiority or Other|||||||0.3953|||||||Log Rank||||
1626817|NCT02193074|2987891|Superiority or Other||Hazard Ratio (HR)|0.24||||0.0014|2-Sided|95.0|0.1002|0.5753|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject’s disease duration at screening.|||
1626818|NCT02193074|2987891|Superiority or Other|||||||0.0003|||||||Log Rank||||
1626819|NCT02193074|2987892|Superiority or Other||Difference in percentages|30.21||||0.0004|2-Sided|95.0|10.35|48.09|||Fisher Exact||||
1626820|NCT02193074|2987894|Superiority or Other||Hazard Ratio (HR)|0.372||||0.0082|2-Sided|95.0|0.1787|0.7745|||Cox proportional hazards|Based on Cox proportional hazards model adjusted for each subject’s disease duration at screening (sensitivity analysis).|||
1626821|NCT02193074|2987894|Superiority or Other|||||||0.0041|||||||Log Rank|Based on log-rank test stratified by disease duration (primary analysis).|||
1626822|NCT02193074|2987895|Superiority or Other||DIfference in percentages|68.53|||<|0.0001|2-Sided|95.0|51.27|81.99|||Fisher Exact||||
1626823|NCT02193074|2987896|Superiority or Other||Hazard Ratio (HR)|0.53||||0.0164|2-Sided|95.0|0.3156|0.8902|||Cox proportional hazards model|Based on Cox proportional hazards model adjusted for each subject’s disease duration at screening.|||
1626824|NCT02193074|2987896|Superiority or Other|||||||0.0046|||||||Log Rank|Based on log-rank test stratified by disease duration.|||
1626825|NCT02193074|2987897|Superiority or Other||Difference in percentages|50.68|||<|0.0001|2-Sided|95.0|31.81|66.48|||Fisher Exact||exact unconditional confidence interval||
1626826|NCT02192905|2987898|Other|One-sample t-test testing the mean positive problem solving change from baseline to week 16.|Mean Difference (Final Values)|-0.76|Standard Deviation|13.07||0.73|2-Sided|95.0|-5.11|3.6|||t-test, 2 sided||||
1626827|NCT02192905|2987899|Other|One-sample t-test testing the mean within-person percent weight change from baseline to week 16.|Mean Difference (Final Values)|-0.017|Standard Deviation|0.011||0.143|2-Sided|95.0|-0.039|0.006|||t-test, 2 sided||||
1627063|NCT02187055|2988277|Superiority or Other||LS mean difference|1.23|||||2-Sided|95.0|-1.556|4.016||||||VAS score|
1626828|NCT02192905|2987900|Other|One-sample t-test testing the mean within-person percent weight change from baseline to week 8.|Mean Difference (Final Values)|-0.019|Standard Deviation|0.03|<|0.001|2-Sided|95.0|-0.0285|-0.0096|||t-test, 2 sided||||
1626829|NCT02192905|2987901|Other|One-sample t-test testing the mean positive problem solving change from baseline to week 8.|Mean Difference (Final Values)|-0.64|Standard Deviation|8.31||0.63|2-Sided|95.0|-3.34|2.05|||t-test, 2 sided||||
1626830|NCT02192164|2987946|Superiority or Other||Mean Difference (Net)|-0.911449|Standard Error of the Mean|1.426517|||2-Sided|95.0|-3.73847|1.915572|||||||
1626831|NCT02192164|2987947|Superiority or Other||Mean Difference (Net)|-2.757334|Standard Error of the Mean|1.594019|||2-Sided|95.0|-5.916307|0.401638|||||||
1626832|NCT02191865|2987950|Superiority or Other||Ratio of geometric means|870.74|Standard Deviation|45.7|||2-Sided|90.0|576.36|1315.49|||||Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-tz) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.|
1626833|NCT02191865|2987950|Superiority or Other||ratio of the geometric means|216.79|Standard Deviation|75.0|||2-Sided|90.0|120.37|390.45|||||Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-tz) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.|
1626834|NCT02191865|2987951|Superiority or Other||Ratio of geometric means|761.01|Standard Deviation|69.1|||2-Sided|90.0|439.01|1319.18|||||Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of Cmax was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.|
1626835|NCT02191865|2987951|Superiority or Other||ratio of the geometric means|221.76|Standard Deviation|61.4|||2-Sided|90.0|134.73|365.01|||||Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of Cmax was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.|
1626836|NCT02191865|2987952|Superiority or Other||Ratio of geometric means|867.13|Standard Deviation|45.9|||2-Sided|90.0|572.93|1312.41|||||Ratio of Child Pugh B (Test): Healthy Child Pugh B (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-inf) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.|
1626837|NCT02191865|2987952|Superiority or Other||ratio of the geometric means|215.39|Standard Deviation|73.5|||2-Sided|90.0|120.71|384.32|||||Ratio of Child Pugh A (Test): Healthy Child Pugh A (Reference). The Standard deviation is the Intra-individual gCV|The statistical model used for the analysis of AUC (0-inf) was an ANOVA (analysis of variance) model on the logarithmic scale. Observations from a subject with hepatic impairment and the matched healthy control subject were analysed as a matched pair.|
1626838|NCT02191579|2987957|Superiority||Odds Ratio (OR)|4.05|||<|0.001||95.0|2.014|8.157||Odds ratio, 95% CI, and p-value for the Week 29-32 interval were estimated using a logistic regression model adjusted by baseline headache days.|Regression, Logistic||||
1626839|NCT02191579|2987958|Superiority||Median Difference (Net)|-4.248|||<|0.001||95.0|-5.766|-2.731||Estimated mean difference, 95% CI, and p-value for Week 30 were assessed using analysis of covariance adjusting for baseline headache days.|ANCOVA||||
1626840|NCT02191579|2987959|Superiority||Mean Difference (Net)|-6.199|||<|0.001|2-Sided|95.0|-7.936|-4.462||Estimated mean difference, 95% CI, and p-value were assessed using analysis of covariance adjusting for baseline headache days.|ANCOVA||||
1626841|NCT02191579|2987960|Superiority||Odds Ratio (OR)|4.94|||<|0.001|2-Sided|95.0|2.681|9.085||Odds ratio, 95% CI, and p-value were estimated using a logistic regression model adjusted by baseline headache days.|Regression, Logistic||||
1626842|NCT02191397|2987976|Other||Odds Ratio (OR)|0.83||||0.485|2-Sided|95.0|0.49|1.4||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626843|NCT02191397|2987976|Other||Odds Ratio (OR)|0.83||||0.417|2-Sided|95.0|0.54|1.29||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626844|NCT02191397|2987976|Other||Odds Ratio (OR)|0.57||||0.007|2-Sided|95.0|0.38|0.86||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626845|NCT02191397|2987976|Other||Odds Ratio (OR)|0.95||||0.822|2-Sided|95.0|0.58|1.54||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626846|NCT02191397|2987976|Other||Odds Ratio, log|0.78||||0.545|2-Sided|95.0|0.35|1.75||P-value was estimated from a GEE model repeated measures with CGI-I score of 1 or 2 as response variable and treatment, gender as explanatory variables|GEE model repeated measures||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626878|NCT02191397|2987984|Other||Odds Ratio (OR)|0.83||||0.354|2-Sided|95.0|0.55|1.24||P-value was estimated from a GEE model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model||||
1627064|NCT02187055|2988277|Superiority or Other||LS mean difference|-0.14|||||2-Sided|95.0|-2.934|2.648||||||VAS score|
1626847|NCT02191397|2987977|Other||Mean Difference (Final Values)|0.2||||0.11|2-Sided|95.0|-0.04|0.35||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626848|NCT02191397|2987977|Other||Mean Difference (Final Values)|0.1||||0.248|2-Sided|95.0|-0.08|0.31||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626849|NCT02191397|2987977|Other||Mean Difference (Final Values)|0.2||||0.036|2-Sided|95.0|0.01|0.38||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626850|NCT02191397|2987977|Other||Mean Difference (Final Values)|0.1||||0.079|2-Sided|95.0|-0.02|0.28||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626851|NCT02191397|2987977|Other||Mean Difference (Final Values)|0.0||||0.804|2-Sided|95.0|-0.1|0.13||Analysis included Baseline CGI-S score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626852|NCT02191397|2987978|Other||Mean Difference (Final Values)|0.2||||0.299|2-Sided|95.0|-0.14|0.46||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626853|NCT02191397|2987978|Other||Mean Difference (Final Values)|0.2||||0.137|2-Sided|95.0|-0.07|0.54||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626854|NCT02191397|2987978|Other||Mean Difference (Final Values)|0.2||||0.207|2-Sided|95.0|-0.11|0.5||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626855|NCT02191397|2987978|Other||Mean Difference (Final Values)|0.4||||0.014|2-Sided|95.0|0.07|0.66||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626856|NCT02191397|2987978|Other||Mean Difference (Final Values)|0.1||||0.438|2-Sided|95.0|-0.16|0.37||Analysis included Baseline HAMD-17 Sleep Disorder subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626857|NCT02191397|2987979|Other||Mean Difference (Final Values)|0.2||||0.37|2-Sided|95.0|-0.25|0.66||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626858|NCT02191397|2987979|Other||Mean Difference (Final Values)|0.0||||0.851|2-Sided|95.0|-0.4|0.48||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626859|NCT02191397|2987979|Other||Mean Difference (Final Values)|0.2||||0.427|2-Sided|95.0|-0.25|0.58||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626860|NCT02191397|2987979|Other||Mean Difference (Final Values)|0.2||||0.209|2-Sided|95.0|-0.13|0.58||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626861|NCT02191397|2987979|Other||Mean Difference (Final Values)|0.1||||0.573|2-Sided|95.0|-0.2|0.35||Analysis included Baseline HAMD-17 Retardation subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626879|NCT02191397|2987985|Other||Odds Ratio (OR)|0.73||||0.129|2-Sided|95.0|0.48|1.1||P-value was estimated from a Generalized Estimating Equation (GEE) model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model||||
1626862|NCT02191397|2987980|Other||Mean Difference (Final Values)|0.3||||0.252|2-Sided|95.0|-0.19|0.71||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626863|NCT02191397|2987980|Other||Mean Difference (Final Values)|0.4||||0.118|2-Sided|95.0|-0.1|0.85||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626864|NCT02191397|2987980|Other||Mean Difference (Final Values)|0.5||||0.062|2-Sided|95.0|-0.02|0.99||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626865|NCT02191397|2987980|Other||Mean Difference (Final Values)|0.4||||0.081|2-Sided|95.0|-0.04|0.75||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626866|NCT02191397|2987980|Other||Mean Difference (Final Values)|-0.2||||0.358|2-Sided|95.0|-0.5|0.18||Analysis included Baseline HAMD-17 anxiety/somatization subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626867|NCT02191397|2987981|Other||Mean Difference (Final Values)|0.0||||0.714|2-Sided|95.0|-0.14|0.2||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626868|NCT02191397|2987981|Other||Mean Difference (Final Values)|0.1||||0.337|2-Sided|95.0|-0.09|0.26||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626869|NCT02191397|2987981|Other||Mean Difference (Final Values)|0.2||||0.05|2-Sided|95.0|0.0|0.34||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626870|NCT02191397|2987981|Other||Mean Difference (Final Values)|0.1||||0.163|2-Sided|95.0|-0.04|0.26||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626871|NCT02191397|2987981|Other||Mean Difference (Final Values)|0.0||||0.579|2-Sided|95.0|-0.09|0.16||Analysis included Baseline HAMD-17 depressed mood subscale score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Comparison for Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626872|NCT02191397|2987982|Other||Mean Difference (Final Values)|0.9||||0.278|2-Sided|95.0|-0.69|2.4||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 8. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626873|NCT02191397|2987982|Other||Mean Difference (Final Values)|0.8||||0.33|2-Sided|95.0|-0.81|2.4||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 6. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626874|NCT02191397|2987982|Other||Mean Difference (Final Values)|1.2||||0.143|2-Sided|95.0|-0.4|2.78||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 4. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626875|NCT02191397|2987982|Other||Mean Difference (Final Values)|1.4||||0.037|2-Sided|95.0|0.08|2.66||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 2. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626876|NCT02191397|2987982|Other||Mean Difference (Final Values)|0.2||||0.627|2-Sided|95.0|-0.7|1.16||Analysis included Baseline MADRS total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Week 1. OC dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626877|NCT02191397|2987983|Other||Odds Ratio (OR)|0.85||||0.489|2-Sided|95.0|0.54|1.34||P-value was estimated from a GEE model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables|GEE model||||
1626880|NCT02191397|2987986|Other||Odds Ratio (OR)|0.85||||0.479|2-Sided|95.0|0.55|1.33||P-value was estimated from a Generalized Estimating Equation (GEE) model with Response based on HADM-17 as response variable and treatment, gender as explanatory variables.|GEE model||||
1626881|NCT02191397|2987987|Non-Inferiority|A one-sided 97.5% confidence interval for the between-treatment difference (bupropion XL-escitalopram) was compared with the pre-defined non-inferiority margin of 2.2. If the upper limit of the one-sided 97.5% confidence interval was below 2.2, then it indicated that bupropion was not inferior in efficacy to escitalopram.|Mean Difference (Final Values)|0.8||||0.139|2-Sided|95.0|-0.27|1.94||Analysis included Baseline HAMD-17 total score as covariate, treatment, gender, visit and treatment-visit interaction as fixed effects. Unstructured covariance matrix was used.|Mixed model repeated measures analysis||Observed Cases (OC) dataset was used, where available data at a given time point was used with no missing values filled in with estimates.||
1626882|NCT02191046|2988016|Non-Inferiority or Equivalence|power fo study = 90%|Mean Difference (Final Values)|5.66|Standard Deviation|3.16|<|0.05|2-Sided|95.0|4.62|6.69|||t-test, 2 sided|||compare the mean 5s-score between before and after treatment in squeezable bottle group|
1626883|NCT02191046|2988016|Non-Inferiority or Equivalence|power of study = 90%|Mean Difference (Net)|-0.47|Standard Deviation|0.17|<|0.05|2-Sided|95.0|-0.82|-0.12|||t-test, 2 sided|||satisfaction score between two groups at 2 weeks after treatment|
1626884|NCT02191046|2988016|Non-Inferiority or Equivalence|power of study = 90%|Mean Difference (Net)|0.93|Standard Deviation|0.42|<|0.05|2-Sided|95.0|0.094|1.76|||t-test, 2 sided|||compare the mean 5S-score between 2 groups at 2 weeks after treatment|
1626885|NCT02191046|2988016|Non-Inferiority or Equivalence|power of study = 90%|Mean Difference (Final Values)|4.38|Standard Deviation|2.89|<|0.05|2-Sided|95.0|3.41|5.37|||t-test, 2 sided|||compare the mean 5S-score between before and after treatment in syringe group|
1626886|NCT02190279|2988097|Equivalence|One way analysis variance.|||||<|0.05|||||||variance||||
1626887|NCT02190279|2988098|Other|||||||0.012|||||||ANOVA|||At 2 hour post injection.|
1626888|NCT02190279|2988098|Other|||||||0.0033|||||||ANOVA|||At 1 hour post injection.|
1626889|NCT02189954|2988108|Superiority or Other||||||<|0.05|||||||Mann Whitney U||||
1626890|NCT02189954|2988108|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1626891|NCT02189837|2988120|Superiority or Other||Treatment Effect|62.72|Standard Error of the Mean|16.02|<|0.001|2-Sided|95.0|30.65|94.79|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.|||
1626892|NCT02189837|2988120|Superiority or Other||LS Mean Treatment Difference|23.28|Standard Error of the Mean|11.05|<|0.039|2-Sided|95.0|1.16|45.4|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.|||
1626893|NCT02189837|2988120|Superiority or Other||LS Mean Treatment Difference|-39.43|Standard Error of the Mean|11.6|<|0.001|2-Sided|95.0|-62.66|-16.21|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.|||
1626894|NCT02189837|2988121|Superiority or Other||Treatment Effect|41.18|Standard Error of the Mean|18.5||0.03|2-Sided|95.0|4.15|78.2|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||To assess whether the treatment effect of evolocumab compared with placebo depended on being administered alone or combined with atorvastatin, the interaction was tested, i.e., the difference between the treatment difference versus the respective placebo group for the evolocumab+atorvastatin group and the evolocumab group was calculated.|
1626895|NCT02189837|2988121|Superiority or Other||LS Mean Treatment Difference|39.06|Standard Error of the Mean|12.76||0.003|2-Sided|95.0|13.52|64.59|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The treatment effect of evolocumab plus atorvastatin compared with placebo plus atorvastatin was estimated and a nominal p-value is provided.|
1626896|NCT02189837|2988121|Superiority or Other||LS Mean Treatment Difference|-2.12|Standard Error of the Mean|13.4||0.87|2-Sided|95.0|-28.94|24.7|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The superiority of evolocumab monotherapy to placebo was tested using a 2-sided p-value at a significance level of 0.05.|
1626897|NCT02189837|2988122|Superiority or Other||Treatment Effect|-16.01|Standard Error of the Mean|14.65||0.28|2-Sided|95.0|-45.18|13.16|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.|||
1626898|NCT02189837|2988122|Superiority or Other||LS Mean Treatment Difference|-32.66|Standard Error of the Mean|10.31||0.002|2-Sided|95.0|-53.19|-12.13|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.|||
1626899|NCT02189837|2988122|Superiority or Other||LS Mean Treatment Difference|-16.65|Standard Error of the Mean|10.41||0.11|2-Sided|95.0|-37.37|4.08|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.|||
1626900|NCT02189837|2988123|Superiority or Other||Treatment Effect|19.2|Standard Error of the Mean|6.15||0.003|2-Sided|95.0|6.93|31.47|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.|||
1626901|NCT02189837|2988123|Superiority or Other||LS Mean Treatment Difference|-37.95|Standard Error of the Mean|4.31|<|0.001|2-Sided|95.0|-46.55|-29.34|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.|||
1626902|NCT02189837|2988123|Superiority or Other||LS Mean Treatment Difference|-57.14|Standard Error of the Mean|4.4|<|0.001||95.0|-65.91|-48.38|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.|||
1626929|NCT02188784|2988172|Superiority or Other||Mean Difference (Net)|21.03||||0.457|2-Sided|95.0|-34.38|76.43|||Regression, Linear||||
1627065|NCT02187055|2988277|Superiority or Other||LS mean difference|-0.02|||||2-Sided|95.0|-0.094|0.055||||||Anxiety/depression score|
1626903|NCT02189837|2988124|Superiority or Other||Treatment Effect|147.59|Standard Error of the Mean|51.61||0.005|2-Sided|95.0|44.8|250.38|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||To assess whether the treatment effect of evolocumab compared with placebo depended on being administered alone or combined with atorvastatin, the interaction was tested, i.e., the difference between the treatment difference versus the respective placebo group for the evolocumab+atorvastatin group and the evolocumab group was calculated.|
1626904|NCT02189837|2988124|Superiority or Other||LS Mean Treatment Difference|236.35|Standard Error of the Mean|36.32|<|0.001|2-Sided|95.0|164.02|308.69|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The treatment effect of evolocumab plus atorvastatin compared with placebo plus atorvastatin was estimated and a nominal p-value is provided.|
1626905|NCT02189837|2988124|Superiority or Other||LS Mean Treatment Difference|88.76|Standard Error of the Mean|36.67|<|0.018|2-Sided|95.0|15.73|161.8|||ANCOVA|Model includes terms for the 2 factors in the factorial design (placebo or evolocumab and oral placebo or statin), their interaction, and LDL-C level.||The superiority of evolocumab monotherapy to placebo was tested using a 2-sided p-value at a significance level of 0.05.|
1626906|NCT02189252|2988146|Superiority or Other||Geometric mean ratio in %|131.74||||0.5955|2-Sided|95.0|44.97|386.0|||Mixed Models Analysis||||
1626907|NCT02189252|2988146|Superiority or Other||Geometric mean ratio in %|376.64||||0.0186|2-Sided|95.0|128.55|1103.5|||Mixed Models Analysis||||
1626908|NCT02189252|2988147|Superiority or Other||Geometric mean ratio in %|104.98||||0.9578|2-Sided|95.0|15.6|706.33|||Mixed Models Analysis||||
1626909|NCT02189252|2988147|Superiority or Other||Geometric mean ratio in %|753.75||||0.0391|2-Sided|95.0|112.03|5071.6|||Mixed Models Analysis||||
1626910|NCT02189252|2988148|Superiority or Other||Geometric mean ratio in %|80.58||||0.5782||95.0|34.55|187.95|||Mixed Models Analysis||||
1626911|NCT02189252|2988148|Superiority or Other||Geometric mean ratio in %|104.78||||0.9034|2-Sided|95.0|44.92|244.41|||Mixed Models Analysis||||
1626912|NCT02189252|2988149|Superiority or Other||Geometric mean ratio in %|69.39||||0.522|2-Sided|95.0|20.07|239.98|||Mixed Models Analysis||||
1626913|NCT02189252|2988149|Superiority or Other||Geometric mean ratio in %|79.36||||0.6833|2-Sided|95.0|22.95|274.45|||Mixed Models Analysis||||
1626914|NCT02189252|2988150|Superiority or Other||Geometric mean ratio in %|187.28||||0.0418|2-Sided|95.0|102.95|340.66||The p-value was only interpreted descriptively|Mixed Models Analysis||||
1626915|NCT02189252|2988150|Superiority or Other||Geometric mean ratio in %|298.91||||0.0025|2-Sided|95.0|164.32|543.74||The p-value was only interpreted descriptively|Mixed Models Analysis||||
1626916|NCT02189252|2988151|Superiority or Other||Geometric mean ratio in %|177.95||||0.1256|2-Sided|95.0|82.22|385.16|||Mixed Models Analysis||||
1626917|NCT02189252|2988151|Superiority or Other||Geometric mean ratio in %|259.19||||0.021|2-Sided|95.0|119.75|560.99|||Mixed Models Analysis||||
1626918|NCT02189252|2988152|Superiority or Other||Geometric mean ratio in %|133.32||||0.3543|2-Sided|95.0|68.49|259.52||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value>0.05). This is the fourth test in the fixed testing sequence.|
1626919|NCT02189252|2988152|Superiority or Other||Geometric mean ratio in %|193.91||||0.0511|2-Sided|95.0|99.61|377.47||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value>0.05). This is the third test in the fixed testing sequence.|
1626920|NCT02189252|2988153|Superiority or Other||Geometric mean ratio in %|121.61||||0.6367|2-Sided|95.0|49.17|300.76||The p-value was only interpreted descriptively|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value>0.05). This is the second test in the fixed testing sequence.|
1626921|NCT02189252|2988153|Superiority or Other||Geometric mean ratio in %|160.05||||0.2702|2-Sided|95.0|64.71|395.82||The closed sequential testing procedure stopped at this step as the P Value is greater than 0.05.|Mixed Models Analysis|||In order to address the issue of multiple testing while maintaining overall type I error, a closed testing sequence was used involving 4 analyses stated in the primary objective of this study. In total, 4 statistical tests, each at a significance level of 5%, were carried along the fixed sequence until the first statistically non-significant treatment difference was observed (i.e. p-value>0.05). This is the first test in the fixed testing sequence.|
1626922|NCT02188784|2988167|Superiority or Other||Mean Difference (Net)|0.77||||0.4006|2-Sided|95.0|-1.04|2.58|||Regression, Linear||||
1626923|NCT02188784|2988168|Superiority or Other||Mean Difference (Net)|3.56||||0.0643|2-Sided|95.0|-0.21|7.33|||Regression, Linear||||
1626924|NCT02188784|2988169|Superiority or Other||Mean Difference (Net)|0.71||||0.6927|2-Sided|95.0|-2.83|4.24|||Regression, Linear|||Change from baseline to week 16|
1626925|NCT02188784|2988169|Superiority or Other||Mean Difference (Net)|3.6||||0.0722|2-Sided|95.0|-0.33|7.52|||Regression, Linear|||Change from baseline to week 8|
1626926|NCT02188784|2988170|Superiority or Other||Mean Difference (Net)|182.43||||0.4296|2-Sided|95.0|-272.14|637.0|||Regression, Linear||||
1626927|NCT02188784|2988171|Superiority or Other||Mean Difference (Net)|-12.67||||0.1921|2-Sided|95.0|-31.71|6.37|||Regression, Linear|||Change from Baseline to Week 16|
1626928|NCT02188784|2988171|Superiority or Other||Mean Difference (Net)|-0.77||||0.9487|2-Sided|95.0|-24.12|22.59|||Regression, Linear|||Change from Baseline to Week 8|
1627353|NCT02186301|2988395|Other||Kaplan-Meier Median|207.0|||||2-Sided|95.0|112.0|260.0|||||||
1626930|NCT02188589|2988174|Equivalence|The difference between the mean baseline and mean follow-up NOSE scores was evaluated by paired t-test with significance indicated by p<0.05.|||||<|0.001|||||||t-test, 2 sided||||
1626931|NCT02187861|2988186|Superiority or Other||Hazard Ratio (HR)|0.51|||||2-Sided|95.0|0.05|5.63|||||HR was calculated using Cox regression.|Unstratified Analysis|
1626932|NCT02187861|2988186|Superiority or Other||Hazard Ratio (HR)|0.48|||||2-Sided|95.0|0.04|5.37|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and OS of prior cancer therapy.|
1626933|NCT02187861|2988188|Superiority or Other||Hazard Ratio (HR)|0.77|||||2-Sided|95.0|0.43|1.36|||||HR was calculated using Cox regression.|Unstratified Analysis|
1626934|NCT02187861|2988188|Superiority or Other||Hazard Ratio (HR)|0.69|||||2-Sided|95.0|0.38|1.24|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and EFS of prior cancer therapy.|
1626935|NCT02187861|2988190|Superiority or Other||Hazard Ratio (HR)|0.77|||||2-Sided|95.0|0.43|1.36|||||HR was calculated using Cox regression.|Unstratified Analysis|
1626936|NCT02187861|2988190|Superiority or Other||Hazard Ratio (HR)|0.69|||||2-Sided|95.0|0.38|1.24|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and PFS of prior cancer therapy.|
1626937|NCT02187861|2988192|Superiority or Other||Hazard Ratio (HR)|0.78|||||2-Sided|95.0|0.43|1.4|||||HR was calculated using Cox regression.|Unstratified Analysis|
1626938|NCT02187861|2988192|Superiority or Other||Hazard Ratio (HR)|0.69|||||2-Sided|95.0|0.38|1.27|||||HR was calculated using Cox regression.|Stratified Analysis: Strata were disease burden and DOR of prior cancer therapy.|
1626939|NCT02187861|2988198|Superiority or Other||Difference in response rates|-7.84|||||2-Sided|95.0|-22.56|6.87||||||At Year 1|
1626940|NCT02187861|2988198|Superiority or Other||Difference in response rates|-15.69|||||2-Sided|95.0|-31.87|0.49||||||At 4-10 weeks after Cycle 6 Day 1|
1626941|NCT02187861|2988199|Superiority or Other||Difference in response rates|3.92|||||2-Sided|95.0|-12.98|20.82||||||At Year 1|
1626942|NCT02187861|2988199|Superiority or Other||Difference in response rates|13.73|||||2-Sided|95.0|-4.24|31.69||||||At 6−8 weeks after Cycle 6 Day 1|
1626943|NCT02187861|2988200|Superiority or Other||Difference in response rates|-7.84|||||2-Sided|95.0|-27.01|11.32|||||||
1626944|NCT02187861|2988201|Superiority or Other||Difference in response rates|1.96|||||2-Sided|95.0|-17.07|20.99|||||||
1626945|NCT02187861|2988202|Superiority or Other||Difference in response rates|1.96|||||2-Sided|95.0|-15.89|19.81|||||||
1626946|NCT02187861|2988203|Superiority or Other||Difference in response rates|3.92|||||2-Sided|95.0|-13.38|21.23|||||||
1626947|NCT02187744|2988219|Superiority or Other||Mean Difference (Final Values)|6.1|Standard Error of the Mean|5.19|||2-Sided|95.0|-4.08|16.27|||||Unstratified analysis.||
1626948|NCT02187744|2988219|Superiority or Other||Mean Difference (Final Values)|5.96|Standard Error of the Mean|5.09|||2-Sided|95.0|-4.01|15.94|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.||
1626949|NCT02187744|2988220|Superiority or Other||Mean Difference (Final Values)|-3.0|Standard Error of the Mean|7.35|||2-Sided|95.0|-17.4|11.4|||||Unstratified analysis.||
1626950|NCT02187744|2988220|Superiority or Other||Mean Difference (Final Values)|-2.81|Standard Error of the Mean|7.03|||2-Sided|95.0|-16.58|10.96|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.||
1626951|NCT02187744|2988222|Non-Inferiority or Equivalence|The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough >20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.|Mean Difference (Final Values)|-1.18|Standard Error of the Mean|3.78|||2-Sided|95.0|-8.59|6.23|||||Unstratified analysis.||
1626952|NCT02187744|2988222|Non-Inferiority or Equivalence|The hypothesis to be tested in this study is the percentage of participants with steady state (Cycle 5) Ctrough >20 μg/mL of PF-05280014 is non-inferior to trastuzumab-EU using a margin of -12.5%.|Mean Difference (Final Values)|-0.76|Standard Error of the Mean|3.7|||2-Sided|95.0|-8.02|6.49|||||Stratified analysis was based on the normal approximation to the binomial distribution, adjusting for the randomization strata of primary tumor size, estrogen receptor status and by progesterone receptor status.||
1626953|NCT02187172|2988223|Superiority||Mean Difference (Final Values)|-910.84|Standard Error of the Mean|729.96||0.2209|2-Sided|95.0|-2395.95|574.27|||Regression, Linear||||
1626954|NCT02187172|2988223|Superiority||Mean Difference (Final Values)|-779.59|Standard Error of the Mean|1049.99||0.4628|2-Sided|95.0|-2911.19|1352.01|||Regression, Linear||||
1626955|NCT02187172|2988224|Superiority||Mean Difference (Final Values)|-12.33|Standard Error of the Mean|3.5||0.0011|2-Sided|95.0|-19.4|-5.25|||Regression, Linear||||
1626956|NCT02187172|2988224|Superiority||Mean Difference (Final Values)|8.32|Standard Error of the Mean|6.3||0.1944|2-Sided|95.0|-4.42|21.06|||Regression, Linear||||
1626957|NCT02187172|2988225|Other|95% CI of proportion achieving PGA clear/almost clear at end of study|Proportion|0.46|||||2-Sided|95.0|0.3|0.63|||||||
1626958|NCT02187172|2988225|Superiority||Difference of proportions|0.53||||0.0005|2-Sided|95.0|0.29|0.78|||Chi-squared|||Comparison during RCT period for binary Physician Global Assessment|
1626959|NCT02187172|2988226|Other|95% CI of proportion achieving PASI90 at end of study|Proportion|0.49|||||2-Sided|95.0|0.32|0.65|||||||
1626960|NCT02187172|2988226|Superiority||Difference of proportions|0.41||||0.0016|2-Sided|95.0|0.2|0.62|||Chi-squared||||
1626961|NCT02187172|2988227|Other|95% CI of proportion achieving PASI75 at end of study|Proportion|0.72|||||2-Sided|95.0|0.55|0.85|||||||
1626962|NCT02187172|2988227|Superiority||Difference of proportions|0.67||||0.0005|2-Sided|95.0|0.45|0.89|||Chi-squared||||
1626963|NCT02187172|2988228|Superiority||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.89||0.9348|2-Sided|95.0|-1.88|1.73|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626964|NCT02187172|2988228|Superiority||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|1.52||0.7507|2-Sided|95.0|-3.56|2.59|||Regression, Linear|||Comparison during RCT period|
1626965|NCT02187172|2988229|Superiority||Mean Difference (Final Values)|3.41|Standard Error of the Mean|3.43||0.327|2-Sided|95.0|-3.54|10.36|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626966|NCT02187172|2988229|Superiority||Mean Difference (Final Values)|4.2|Standard Error of the Mean|5.18||0.4226|2-Sided|95.0|-6.28|14.68|||Regression, Linear|||Comparison during RCT period|
1626967|NCT02187172|2988230|Superiority||Mean Difference (Final Values)|-7.96|Standard Error of the Mean|85.98||0.9267|2-Sided|95.0|-182.18|166.26|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626968|NCT02187172|2988230|Superiority||Mean Difference (Final Values)|-68.95|Standard Error of the Mean|131.9||0.6042|2-Sided|95.0|-335.97|198.08|||Regression, Linear|||Comparison during RCT period|
1626969|NCT02187172|2988231|Superiority||Mean Difference (Final Values)|6926.25|Standard Error of the Mean|2257.84||0.004|2-Sided|95.0|2351.43|11501.07|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626970|NCT02187172|2988231|Superiority||Mean Difference (Final Values)|3320.58|Standard Error of the Mean|3414.9||0.337|2-Sided|95.0|-3592.52|10233.67|||Regression, Linear|||Comparison during RCT period|
1626971|NCT02187172|2988232|Superiority||Mean Difference (Final Values)|0.38|Standard Error of the Mean|0.51||0.4608|2-Sided|95.0|-0.65|1.4|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626972|NCT02187172|2988232|Superiority||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|1.11||0.8036|2-Sided|95.0|-2.52|1.97|||Regression, Linear|||Comparison during RCT period|
1626973|NCT02187172|2988233|Superiority||Mean Difference (Final Values)|-49.56|Standard Error of the Mean|27.84||0.0833|2-Sided|95.0|-105.97|6.85|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626974|NCT02187172|2988233|Superiority||Mean Difference (Final Values)|48.43|Standard Error of the Mean|61.62||0.4368|2-Sided|95.0|-76.31|173.16|||Regression, Linear|||Comparison during RCT period|
1626975|NCT02187172|2988234|Superiority||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.06||0.1087|2-Sided|95.0|-0.02|0.23|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626976|NCT02187172|2988234|Superiority||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.13||0.2453|2-Sided|95.0|-0.11|0.41|||Regression, Linear||||
1626977|NCT02187172|2988235|Superiority||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.03||0.2559|2-Sided|95.0|-0.03|0.1|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626978|NCT02187172|2988235|Superiority||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.04||0.1792|2-Sided|95.0|-0.03|0.14|||Regression, Linear|||Comparison during RCT period|
1626979|NCT02187172|2988236|Superiority||Mean Difference (Final Values)|-2.97|Standard Error of the Mean|25.7||0.9085|2-Sided|95.0|-55.04|49.09|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626980|NCT02187172|2988236|Superiority||Mean Difference (Final Values)|152.68|Standard Error of the Mean|43.76||0.0012|2-Sided|95.0|64.07|241.23|||Regression, Linear|||Comparison during RCT period|
1626981|NCT02187172|2988237|Superiority||Mean Difference (Final Values)|2.3|Standard Error of the Mean|1.08||0.0394|2-Sided|95.0|0.12|4.48|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626982|NCT02187172|2988237|Superiority||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|1.3||0.8321|2-Sided|95.0|-2.91|2.36|||Regression, Linear|||Comparison during RCT period|
1626983|NCT02187172|2988238|Superiority||Mean Difference (Final Values)|0.38|Standard Error of the Mean|2.59||0.8836|2-Sided|95.0|-4.86|5.63|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626984|NCT02187172|2988238|Superiority||Mean Difference (Final Values)|0.08|Standard Error of the Mean|5.16||0.988|2-Sided|95.0|-10.37|10.53|||Regression, Linear|||Comparison during RCT period|
1626985|NCT02187172|2988239|Superiority||Mean Difference (Final Values)|-1.86|Standard Error of the Mean|2.43||0.4485|2-Sided|95.0|-6.77|3.06|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626986|NCT02187172|2988239|Superiority||Mean Difference (Final Values)|0.34|Standard Error of the Mean|4.57||0.9415|2-Sided|95.0|-8.91|9.59|||Regression, Linear|||Comparison during RCT period|
1626987|NCT02187172|2988240|Superiority||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|2.07||0.8119|2-Sided|95.0|-4.69|3.7|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626988|NCT02187172|2988240|Superiority||Mean Difference (Final Values)|-15.71|Standard Error of the Mean|5.77||0.0097|2-Sided|95.0|-27.39|-4.03|||Regression, Linear|||Comparison during RCT period|
1626989|NCT02187172|2988241|Superiority||Mean Difference (Final Values)|11.14|Standard Error of the Mean|7.33||0.1373|2-Sided|95.0|-3.72|25.99|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626990|NCT02187172|2988241|Superiority||Mean Difference (Net)|-9.21|Standard Error of the Mean|11.76||0.4384|2-Sided|95.0|-33.03|14.6|||Regression, Linear|||Comparison during RCT period|
1626991|NCT02187172|2988242|Superiority||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|3.37||0.9734|2-Sided|95.0|-6.93|6.71|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626992|NCT02187172|2988242|Superiority||Mean Difference (Final Values)|-16.74|Standard Error of the Mean|6.57||0.0149|2-Sided|95.0|-30.03|-3.45|||Regression, Linear|||Comparison during RCT period|
1626993|NCT02187172|2988243|Superiority||Mean Difference (Final Values)|1.5|Standard Error of the Mean|1.41||0.295|2-Sided|95.0|-1.36|4.36|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment|
1626994|NCT02187172|2988243|Superiority||Mean Difference (Final Values)|3.14|Standard Error of the Mean|2.81||0.2704|2-Sided|95.0|-2.55|8.83|||Regression, Linear|||Comparison during RCT period|
1626995|NCT02187172|2988244|Superiority||Mean Difference (Final Values)|-29.16|Standard Error of the Mean|38.01||0.4478|2-Sided|95.0|-106.17|47.85|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1626996|NCT02187172|2988244|Superiority||Mean Difference (Final Values)|194.69|Standard Error of the Mean|66.23||0.0056|2-Sided|95.0|60.61|328.77|||Regression, Linear|||Comparison during RCT period|
1627833|NCT02170779|2989699|Superiority or Other|||||||0.84|||||||Wilcoxon (Mann-Whitney)||||
1626997|NCT02187172|2988245|Superiority||Mean Difference (Final Values)|-24.74|Standard Error of the Mean|32.59||0.4527|2-Sided|95.0|-90.78|41.3|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1626998|NCT02187172|2988245|Superiority||Mean Difference (Final Values)|7.01|Standard Error of the Mean|48.81||0.8866|2-Sided|95.0|-91.8|105.81|||Regression, Linear|||Comparison during RCT period|
1626999|NCT02187172|2988246|Superiority||Mean Difference (Final Values)|4.68|Standard Error of the Mean|33.85||0.8907|2-Sided|95.0|-63.91|73.28|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627000|NCT02187172|2988246|Superiority||Mean Difference (Final Values)|46.96|Standard Error of the Mean|56.12||0.4079|2-Sided|95.0|-66.65|160.57|||Regression, Logistic|||Comparison during RCT period|
1627001|NCT02187172|2988247|Superiority||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.11||0.8068|2-Sided|95.0|-0.19|0.24|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627002|NCT02187172|2988247|Superiority||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.17||0.8008|2-Sided|95.0|-0.3|0.38|||Regression, Linear|||Comparison during RCT period|
1627003|NCT02187172|2988248|Superiority||Mean Difference (Final Values)|-31.89|Standard Error of the Mean|41.71||0.4493|2-Sided|95.0|-116.4|52.61|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627004|NCT02187172|2988248|Superiority||Mean Difference (Final Values)|230.77|Standard Error of the Mean|69.8||0.0021|2-Sided|95.0|89.47|372.08|||Regression, Linear|||Comparison during RCT period|
1627005|NCT02187172|2988249|Superiority||Mean Difference (Final Values)|-2.92|Standard Error of the Mean|4.07||0.4775|2-Sided|95.0|-11.17|5.33|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627006|NCT02187172|2988249|Superiority||Mean Difference (Final Values)|21.37|Standard Error of the Mean|6.67||0.0027|2-Sided|95.0|7.86|34.87|||Regression, Linear|||Comparison during RCT period|
1627007|NCT02187172|2988250|Superiority||Mean Difference (Final Values)|0.77|Standard Error of the Mean|1.0||0.4454|2-Sided|95.0|-1.25|2.8|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627008|NCT02187172|2988250|Superiority||Mean Difference (Final Values)|-1.12|Standard Error of the Mean|1.89||0.558|2-Sided|95.0|-4.95|2.71|||Regression, Linear|||Comparison during RCT period|
1627009|NCT02187172|2988251|Superiority||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.97||0.8653|2-Sided|95.0|-1.8|2.13|||Regression, Linear|||Comparison during RCT period|
1627010|NCT02187172|2988251|Superiority||Mean Difference (Final Values)|-1.37|Standard Error of the Mean|1.69||0.4235|2-Sided|95.0|-4.79|2.05|||Regression, Linear|||Comparison during RCT period|
1627011|NCT02187172|2988252|Superiority||Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.84||0.8054|2-Sided|95.0|-1.49|1.91|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627012|NCT02187172|2988252|Superiority||Mean Difference (Final Values)|2.49|Standard Error of the Mean|1.7||0.1502|2-Sided|95.0|-0.94|5.93|||Regression, Linear|||Comparison during RCT period|
1627013|NCT02187172|2988253|Superiority||Mean Difference (Final Values)|0.51|Standard Error of the Mean|0.36||0.1651|2-Sided|95.0|-0.22|1.24|||Regression, Logistic|||Global change from baseline after 52 weeks of active treatment.|
1627014|NCT02187172|2988253|Superiority||Mean Difference (Net)|0.12|Standard Error of the Mean|0.6||0.8383|2-Sided|95.0|-1.09|1.33|||Regression, Linear|||Comparison during RCT period|
1627015|NCT02187172|2988254|Superiority||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.07||0.0137|2-Sided|95.0|0.04|0.31|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627016|NCT02187172|2988254|Superiority||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.11||0.3212|2-Sided|95.0|-0.34|0.11|||Regression, Linear|||Comparison during RCT period|
1627017|NCT02187172|2988255|Superiority||Mean Difference (Final Values)|0.91|Standard Error of the Mean|0.72||0.2189|2-Sided|95.0|-0.53|2.37|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627018|NCT02187172|2988255|Superiority||Mean Difference (Final Values)|1.25|Standard Error of the Mean|1.03||0.2305|2-Sided|95.0|-0.83|3.34|||Regression, Linear|||Comparison during RCT period|
1627019|NCT02187172|2988256|Superiority||Mean Difference (Final Values)|1.92|Standard Error of the Mean|1.42||0.1841|2-Sided|95.0|-0.96|4.8|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627020|NCT02187172|2988256|Superiority||Mean Difference (Final Values)|3.66|Standard Error of the Mean|1.96||0.0693|2-Sided|95.0|-0.3|7.62|||Regression, Linear|||Comparison during RCT period|
1627021|NCT02187172|2988257|Superiority||Mean Difference (Final Values)|-0.79|Standard Error of the Mean|4.14||0.8499|2-Sided|95.0|-9.19|7.61|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627022|NCT02187172|2988257|Superiority||Mean Difference (Final Values)|19.2|Standard Error of the Mean|7.41||0.0135|2-Sided|95.0|4.21|34.2|||Regression, Linear|||Comparison during RCT period|
1627023|NCT02187172|2988258|Superiority||Mean Difference (Final Values)|10.55|Standard Error of the Mean|8.26||0.2093|2-Sided|95.0|-6.18|27.29|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627024|NCT02187172|2988258|Superiority||Mean Difference (Final Values)|2.06|Standard Error of the Mean|12.91||0.8744|2-Sided|95.0|-24.09|28.2|||Regression, Linear|||Comparison during RCT period|
1627025|NCT02187172|2988259|Superiority||Mean Difference (Final Values)|-2.23|Standard Error of the Mean|1.71||0.1988|2-Sided|95.0|-5.69|1.22|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627026|NCT02187172|2988259|Superiority||Mean Difference (Final Values)|-16.87|Standard Error of the Mean|15.62||0.2869|2-Sided|95.0|-48.48|14.75|||Regression, Linear|||Comparison during RCT period|
1627027|NCT02187172|2988260|Superiority||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.21||0.0713|2-Sided|95.0|-0.8|0.03|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627028|NCT02187172|2988260|Superiority||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|-0.47||0.2333|2-Sided|95.0|-1.25|0.32|||Regression, Linear|||Comparison during RCT period|
1628208|NCT02160899|2990493|Superiority|||||||0.044|||||||Exact Wilcoxon Rank Sum Test||||
1627029|NCT02187172|2988261|Superiority||Mean Difference (Final Values)|-407.43|Standard Error of the Mean|180.7||0.0302|2-Sided|95.0|-773.57|-41.29|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627030|NCT02187172|2988261|Superiority||Mean Difference (Final Values)|-155.31|Standard Error of the Mean|688.28||0.8227|2-Sided|95.0|-1548.66|1238.04|||Regression, Linear|||Comparison during RCT period|
1627031|NCT02187172|2988262|Superiority||Mean Difference (Final Values)|-1.15|Standard Error of the Mean|0.32||0.0008|2-Sided|95.0|-1.79|-0.51|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627032|NCT02187172|2988262|Superiority||Mean Difference (Final Values)|-2.63|Standard Error of the Mean|0.98||0.011|2-Sided|95.0|-4.62|-0.64|||Regression, Linear|||Comparison during RCT period|
1627033|NCT02187172|2988263|Superiority||Mean Difference (Final Values)|171.21|Standard Error of the Mean|20.3|<|0.0001|2-Sided|95.0|130.08|212.34|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627034|NCT02187172|2988263|Superiority||Mean Difference (Final Values)|191.49|Standard Error of the Mean|46.1|<|0.0002|2-Sided|95.0|98.18|284.81|||Regression, Linear|||Comparison during RCT period|
1627035|NCT02187172|2988264|Superiority||Mean Difference (Final Values)|71.72|Standard Error of the Mean|132.87||0.5926|2-Sided|95.0|-197.5|340.93|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627036|NCT02187172|2988264|Superiority||Mean Difference (Final Values)|-70.76|Standard Error of the Mean|33.42||0.0408|2-Sided|95.0|-138.42|-3.11|||Regression, Linear|||Comparison during RCT period|
1627037|NCT02187172|2988265|Superiority||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.11||0.0106|2-Sided|95.0|-0.54|-0.08|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627038|NCT02187172|2988265|Superiority||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.51||0.3124|2-Sided|95.0|-1.56|0.51|||Regression, Linear|||Comparison during RCT period|
1627039|NCT02187172|2988266|Superiority||Mean Difference (Final Values)|-8.35|Standard Error of the Mean|8.41||0.3271|2-Sided|95.0|-25.4|8.69|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627040|NCT02187172|2988266|Superiority||Mean Difference (Final Values)|-4.14|Standard Error of the Mean|11.41||0.7185|2-Sided|95.0|-27.24|18.96|||Regression, Linear|||Comparison during RCT period|
1627041|NCT02187172|2988267|Superiority||Mean Difference (Final Values)|-0.67|Standard Error of the Mean|0.34||0.058|2-Sided|95.0|-1.36|0.02|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627042|NCT02187172|2988267|Superiority||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.68||0.1928|2-Sided|95.0|-2.27|0.47|||Regression, Linear|||Comparison during RCT period|
1627043|NCT02187172|2988268|Superiority||Mean Difference (Final Values)|-7.24|Standard Error of the Mean|11.47||0.5316|2-Sided|95.0|-30.47|15.99|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627044|NCT02187172|2988268|Superiority||Mean Difference (Final Values)|-14.79|Standard Error of the Mean|19.96||0.4632|2-Sided|95.0|-55.19|25.61|||Regression, Linear|||Comparison during RCT period|
1627045|NCT02187172|2988269|Superiority||Mean Difference (Final Values)|-1.09|Standard Error of the Mean|1.09||0.3205|2-Sided|95.0|-3.29|1.11|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627046|NCT02187172|2988269|Superiority||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|2.54||0.9767|2-Sided|95.0|-5.22|5.07|||Regression, Linear|||Comparison during RCT period|
1627047|NCT02187172|2988270|Superiority||Mean Difference (Final Values)|-3782.54|Standard Error of the Mean|4073.25||0.3591|2-Sided|95.0|-12035.72|4470.64|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627048|NCT02187172|2988270|Superiority||Mean Difference (Final Values)|-7884.29|Standard Error of the Mean|7780.29||0.3173|2-Sided|95.0|-23634.67|7566.1|||Regression, Linear|||Comparison during RCT period|
1627049|NCT02187172|2988271|Superiority||Mean Difference (Final Values)|47.0|Standard Error of the Mean|35.84||0.1979|2-Sided|95.0|-25.63|11963.0|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627050|NCT02187172|2988271|Superiority||Mean Difference (Final Values)|20.66|Standard Error of the Mean|24.75||0.6742|2-Sided|95.0|-78.03|119.34|||Regression, Linear|||Comparison during RCT period|
1627051|NCT02187172|2988272|Superiority||Mean Difference (Final Values)|-1974.63|Standard Error of the Mean|1659.11||0.2416|2-Sided|95.0|-5336.3|1387.04|||Regression, Linear|||Combined ustekinumab and placebo groups for active treatment period analysis.|
1627052|NCT02187172|2988272|Superiority||Mean Difference (Final Values)|-3027.21|Standard Error of the Mean|3180.58||0.3472|2-Sided|95.0|-9465.95|3411.54|||Regression, Linear|||Comparison during RCT period|
1627053|NCT02187172|2988273|Superiority||Mean Difference (Final Values)|-1.99|Standard Error of the Mean|14.11||0.8883|2-Sided|95.0|-30.58|26.59|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627054|NCT02187172|2988273|Superiority||Mean Difference (Final Values)|-80.89|Standard Error of the Mean|30.46||0.0115|2-Sided|95.0|-142.55|-19.23|||Regression, Linear|||Comparison during RCT period|
1627055|NCT02187172|2988274|Superiority||Mean Difference (Final Values)|6.65|Standard Error of the Mean|22.24||0.7666|2-Sided|95.0|-38.41|51.72|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627056|NCT02187172|2988274|Superiority||Mean Difference (Final Values)|-64.97|Standard Error of the Mean|44.88||0.1159|2-Sided|95.0|-115.83|25.89|||Regression, Linear|||Comparison during RCT period|
1627057|NCT02187172|2988275|Superiority||Mean Difference (Final Values)|-0.0151|Standard Error of the Mean|0.0353||0.6718|2-Sided|95.0|-0.0867|0.0565|||Regression, Linear|||Global change from baseline after 52 weeks of active treatment.|
1627058|NCT02187172|2988275|Superiority||Mean Difference (Final Values)|-0.2456|Standard Error of the Mean|0.07||0.0012|2-Sided|95.0|-0.3873|-0.104|||Regression, Linear|||Comparison during RCT period|
1627059|NCT02187055|2988276|Superiority or Other||LS mean difference|1.52|||||2-Sided|95.0|0.266|2.779|||||||
1627060|NCT02187055|2988276|Superiority or Other||LS mean difference|1.07|||||2-Sided|95.0|-0.178|2.325|||||||
1627061|NCT02187055|2988276|Superiority or Other||LS mean difference|-0.45|||||2-Sided|95.0|-1.706|0.808|||||||
1627062|NCT02187055|2988277|Superiority or Other||LS mean difference|1.37|||||2-Sided|95.0|-1.425|4.171||||||VAS score|
1627066|NCT02187055|2988277|Superiority or Other||LS mean difference|0.01|||||2-Sided|95.0|-0.066|0.083||||||Anxiety/depression score|
1627067|NCT02187055|2988277|Superiority or Other||LS mean difference|0.03|||||2-Sided|95.0|-0.046|0.103||||||Anxiety/depression score|
1627068|NCT02187055|2988277|Superiority or Other||LS mean difference|0.03|||||2-Sided|95.0|-0.041|0.091||||||Pain/discomfort score|
1627069|NCT02187055|2988277|Superiority or Other||LS mean difference|0.05|||||2-Sided|95.0|-0.015|0.116||||||Pain/discomfort score|
1627070|NCT02187055|2988277|Superiority or Other||LS mean difference|0.03|||||2-Sided|95.0|-0.041|0.091||||||Pain/discomfort score|
1627071|NCT02187055|2988277|Superiority or Other||LS mean difference|0.04|||||2-Sided|95.0|-0.029|0.118||||||Usual activities score|
1627072|NCT02187055|2988277|Superiority or Other||LS mean difference|0.06|||||2-Sided|95.0|-0.018|0.129||||||Usual activities score|
1627073|NCT02187055|2988277|Superiority or Other||LS mean difference|0.01|||||2-Sided|95.0|-0.062|0.084||||||Usual activities score|
1627074|NCT02187055|2988277|Superiority or Other||LS mean difference|-0.01|||||2-Sided|95.0|-0.083|0.058||||||Self-care score|
1627075|NCT02187055|2988277|Superiority or Other||LS mean difference|0.04|||||2-Sided|95.0|-0.027|0.114||||||Self-care score|
1627076|NCT02187055|2988277|Superiority or Other||LS mean difference|0.06|||||2-Sided|95.0|-0.014|0.127||||||Self-care score|
1627077|NCT02187055|2988277|Superiority or Other||LS mean difference|0.02|||||2-Sided|95.0|-0.051|0.089||||||Mobility score|
1627078|NCT02187055|2988277|Superiority or Other||LS mean difference|-0.01|||||2-Sided|95.0|-0.079|0.06||||||Mobility score|
1627079|NCT02187055|2988277|Superiority or Other||LS mean difference|-0.03|||||2-Sided|95.0|-0.098|0.042||||||Mobility score|
1627080|NCT02187055|2988277|Superiority or Other||LS mean difference|0.0|||||2-Sided|95.0|-0.031|0.036||||||Utility score|
1627081|NCT02187055|2988277|Superiority or Other||LS mean difference|-0.02|||||2-Sided|95.0|-0.054|0.013||||||Utility score|
1627082|NCT02187055|2988277|Superiority or Other||LS mean difference|-0.02|||||2-Sided|95.0|-0.057|0.011||||||Utility score|
1627083|NCT02187055|2988278|Superiority or Other||LS mean difference|-2.3|||||2-Sided|95.0|-5.818|1.225||||||% activity impairment due to health|
1627084|NCT02187055|2988278|Superiority or Other||LS mean difference|0.08|||||2-Sided|95.0|-3.411|3.573||||||% activity impairment due to health|
1627085|NCT02187055|2988278|Superiority or Other||LS mean difference|2.38|||||2-Sided|95.0|-1.118|5.873||||||% activity impairment due to health|
1627086|NCT02187055|2988278|Superiority or Other||LS mean difference|-0.4|||||2-Sided|95.0|-7.307|6.51||||||% overall work impairment due to health|
1627087|NCT02187055|2988278|Superiority or Other||LS mean difference|1.71|||||2-Sided|95.0|-5.164|8.58||||||% overall work impairment due to health|
1627088|NCT02187055|2988278|Superiority or Other||LS mean difference|2.11|||||2-Sided|95.0|-4.664|8.877||||||% overall work impairment due to health|
1627089|NCT02187055|2988278|Superiority or Other||LS mean difference|-1.92|||||2-Sided|95.0|-7.839|3.998||||||% impairment while working due to health|
1627090|NCT02187055|2988278|Superiority or Other||LS mean difference|0.15|||||2-Sided|95.0|-5.777|6.068||||||% impairment while working due to health|
1627091|NCT02187055|2988278|Superiority or Other||LS mean difference|2.07|||||2-Sided|95.0|-3.726|7.858||||||% impairment while working due to health|
1627092|NCT02187055|2988278|Superiority or Other||LS mean difference|-1.54|||||2-Sided|95.0|-6.283|3.207||||||% work time missed due to health|
1627093|NCT02187055|2988278|Superiority or Other||LS mean difference|-2.64|||||2-Sided|95.0|-7.339|2.067||||||% work time missed due to health|
1627094|NCT02187055|2988278|Superiority or Other||LS mean difference|-1.1|||||2-Sided|95.0|-5.748|3.553||||||% work time missed due to health|
1627095|NCT02187055|2988278|Superiority or Other||LS mean difference|-0.23|||||2-Sided|95.0|-0.582|0.122||||||Problem affecting daily activities|
1627096|NCT02187055|2988278|Superiority or Other||LS mean difference|0.01|||||2-Sided|95.0|-0.341|0.357||||||Problem affecting daily activities|
1627097|NCT02187055|2988278|Superiority or Other||LS mean difference|0.24|||||2-Sided|95.0|-0.112|0.587||||||Problem affecting daily activities|
1627098|NCT02187055|2988278|Superiority or Other||LS mean difference|-0.19|||||2-Sided|95.0|-0.784|0.4||||||Problems affecting productivity|
1627099|NCT02187055|2988278|Superiority or Other||LS mean difference|0.01|||||2-Sided|95.0|-0.578|0.607||||||Problems affecting productivity|
1627100|NCT02187055|2988278|Superiority or Other||LS mean difference|0.21|||||2-Sided|95.0|-0.373|0.786||||||Problems affecting productivity|
1627101|NCT02187055|2988278|Superiority or Other||LS mean difference|-2.1|||||2-Sided|95.0|-6.65|2.454||||||Hours worked in past 7 days|
1627102|NCT02187055|2988278|Superiority or Other||LS mean difference|2.85|||||2-Sided|90.0|-1.736|7.43||||||Hours worked in past 7 days|
1627103|NCT02187055|2988278|Superiority or Other||LS mean difference|4.95|||||2-Sided|95.0|0.52|9.37||||||Hours worked in past 7 days|
1627104|NCT02187055|2988278|Superiority or Other||LS mean difference|1.2|||||2-Sided|95.0|-1.52|3.911||||||Work hours missed other reason|
1627105|NCT02187055|2988278|Superiority or Other||LS mean difference|0.9|||||2-Sided|95.0|-1.832|3.64||||||Work hours missed other reason|
1627106|NCT02187055|2988278|Superiority or Other||LS mean difference|-0.29|||||2-Sided|95.0|-2.928|2.346||||||Work hours missed other reason|
1627107|NCT02187055|2988278|Superiority or Other||LS mean difference|-0.44|||||2-Sided|95.0|-2.349|1.462||||||Work hours missed due to problems|
1627108|NCT02187055|2988278|Superiority or Other||LS mean difference|-0.87|||||2-Sided|95.0|-2.783|1.044||||||Work hours missed due to problems|
1627109|NCT02187055|2988278|Superiority or Other||LS mean difference|-0.43|||||2-Sided|95.0|-2.279|1.427||||||Work hours missed due to problems|
1627110|NCT02187055|2988279|Superiority or Other||LS mean difference|0.5|||||2-Sided|95.0|-0.78|1.86|||||||
1627111|NCT02187055|2988279|Superiority or Other||LS mean difference|0.3|||||2-Sided|95.0|-1.01|1.62|||||||
1627112|NCT02187055|2988279|Superiority or Other||LS mean difference|-0.2|||||2-Sided|95.0|-1.55|1.08|||||||
1627113|NCT02187055|2988280|Superiority or Other||LS mean difference|1.8|||||2-Sided|95.0|0.3|3.24|||||||
1627114|NCT02187055|2988280|Superiority or Other||LS mean difference|0.7|||||2-Sided|95.0|-0.76|2.16|||||||
1627115|NCT02187055|2988280|Superiority or Other||LS mean difference|-1.1|||||2-Sided|95.0|-2.54|0.39|||||||
1627116|NCT02187055|2988281|Superiority or Other||LS mean difference|1.1|||||2-Sided|95.0|-0.26|2.39|||||||
1627117|NCT02187055|2988281|Superiority or Other||LS mean difference|0.2|||||2-Sided|95.0|-1.13|1.51|||||||
1627118|NCT02187055|2988281|Superiority or Other||LS mean difference|-0.9|||||2-Sided|95.0|-2.2|0.45|||||||
1627119|NCT02187055|2988282|Superiority or Other||LS mean difference|0.4|||||2-Sided|95.0|-0.83|1.57|||||||
1627120|NCT02187055|2988282|Superiority or Other||LS mean difference|-0.1|||||2-Sided|95.0|-1.33|1.05|||||||
1627121|NCT02187055|2988282|Superiority or Other||LS mean difference|-0.5|||||2-Sided|95.0|-1.71|0.68|||||||
1627122|NCT02187055|2988283|Superiority or Other||LS mean difference|0.9|||||2-Sided|95.0|-0.25|1.98|||||||
1627123|NCT02187055|2988283|Superiority or Other||LS mean difference|-0.3|||||2-Sided|95.0|-1.4|0.82|||||||
1627124|NCT02187055|2988283|Superiority or Other||LS mean difference|-1.2|||||2-Sided|95.0|-2.27|-0.05|||||||
1627125|NCT02187055|2988284|Superiority or Other||LS mean difference|0.3|||||2-Sided|95.0|-0.89|1.55|||||||
1627126|NCT02187055|2988284|Superiority or Other||LS mean difference|-1.7|||||2-Sided|95.0|-2.91|-0.47|||||||
1627127|NCT02187055|2988284|Superiority or Other||LS mean difference|-2.0|||||2-Sided|95.0|-3.25|-0.8|||||||
1627128|NCT02187055|2988285|Superiority or Other||LS mean difference|0.7|||||2-Sided|95.0|-0.47|1.91|||||||
1627129|NCT02187055|2988285|Superiority or Other||LS mean difference|0.4|||||2-Sided|95.0|-0.8|1.58|||||||
1627130|NCT02187055|2988285|Superiority or Other||LS mean difference|-0.3|||||2-Sided|95.0|-1.52|0.87|||||||
1627131|NCT02187055|2988286|Superiority or Other||LS mean difference|0.0|||||2-Sided|95.0|-1.27|1.34|||||||
1627132|NCT02187055|2988286|Superiority or Other||LS mean difference|-0.9|||||2-Sided|95.0|-2.19|0.42|||||||
1627133|NCT02187055|2988286|Superiority or Other||LS mean difference|-0.9|||||2-Sided|95.0|-2.22|0.39|||||||
1627134|NCT02187055|2988287|Superiority or Other||LS mean difference|1.3|||||2-Sided|95.0|-0.04|2.56|||||||
1627135|NCT02187055|2988287|Superiority or Other||LS mean difference|0.8|||||2-Sided|95.0|-0.48|2.11|||||||
1627136|NCT02187055|2988287|Superiority or Other||LS mean difference|-0.4|||||2-Sided|95.0|-1.74|0.85|||||||
1627137|NCT02187055|2988288|Superiority or Other||LS mean difference|0.1|||||2-Sided|95.0|-0.97|1.2|||||||
1627138|NCT02187055|2988288|Superiority or Other||LS mean difference|-1.1|||||2-Sided|95.0|-2.16|0.01|||||||
1627139|NCT02187055|2988288|Superiority or Other||LS mean difference|-1.2|||||2-Sided|95.0|-2.28|-0.11|||||||
1627140|NCT02187055|2988289|Superiority or Other||Difference in response rate|2.86|||||2-Sided|95.0|-3.72|9.43|||||||
1627141|NCT02187055|2988289|Superiority or Other||Difference in response rate|-1.21|||||2-Sided|95.0|-7.87|5.44|||||||
1627142|NCT02187055|2988289|Superiority or Other||Difference in response rate|-4.07|||||2-Sided|95.0|-10.68|2.55|||||||
1627143|NCT02187055|2988290|Superiority or Other||LS mean difference|-0.04|||||2-Sided|95.0|-0.122|0.037|||||||
1627144|NCT02187055|2988290|Superiority or Other||LS mean difference|0.03|||||2-Sided|95.0|-0.054|0.105|||||||
1627145|NCT02187055|2988290|Superiority or Other||LS mean difference|0.07|||||2-Sided|95.0|-0.011|0.148|||||||
1627146|NCT02187055|2988291|Superiority or Other||Difference in response rate|4.27|||||2-Sided|95.0|-1.68|10.23|||||||
1627147|NCT02187055|2988291|Superiority or Other||Difference in response rate|-2.5|||||2-Sided|95.0|-8.09|3.1|||||||
1627148|NCT02187055|2988291|Superiority or Other||Difference in response rate|-6.77|||||2-Sided|95.0|-12.61|-0.93|||||||
1627149|NCT02187055|2988292|Superiority or Other||Difference in response rate|2.15|||||2-Sided|95.0|-4.22|8.52|||||||
1627150|NCT02187055|2988292|Superiority or Other||Difference in response rate|-6.14|||||2-Sided|95.0|-12.72|0.44|||||||
1627151|NCT02187055|2988292|Superiority or Other||Difference in response rate|-8.29|||||2-Sided|95.0|-14.84|-1.75|||||||
1627152|NCT02187055|2988293|Superiority or Other||Difference in rresponse rate|-0.61|||||2-Sided|95.0|-7.7|6.47|||||||
1627153|NCT02187055|2988293|Superiority or Other||Difference in response rate|-5.48|||||2-Sided|95.0|-12.49|1.52|||||||
1627154|NCT02187055|2988293|Superiority or Other||Difference in response rate|-4.87|||||2-Sided|95.0|-11.92|2.18|||||||
1627155|NCT02187055|2988294|Superiority or Other||Difference in response rate|-0.87|||||2-Sided|95.0|-7.17|5.44|||||||
1627156|NCT02187055|2988294|Superiority or Other||Difference in response rate|-6.89|||||2-Sided|95.0|-12.9|-0.87|||||||
1627157|NCT02187055|2988294|Superiority or Other||Difference in response rate|-6.02|||||2-Sided|95.0|-12.05|0.0|||||||
1627158|NCT02187055|2988295|Superiority or Other||Difference in response rate|2.3|||||2-Sided|95.0|-4.79|9.39|||||||
1627159|NCT02187055|2988295|Superiority or Other||Difference in response rate|-3.93|||||2-Sided|95.0|-10.94|3.09|||||||
1627160|NCT02187055|2988295|Superiority or Other||Difference in response rate|-6.22|||||2-Sided|95.0|-13.29|0.85|||||||
1627161|NCT02187055|2988296|Superiority or Other||Difference in response rate|2.58|||||2-Sided|95.0|-4.51|9.68|||||||
1627162|NCT02187055|2988296|Superiority or Other||Difference in response rate|-3.66|||||2-Sided|95.0|-10.69|3.37|||||||
1627163|NCT02187055|2988296|Superiority or Other||Difference in response rate|-6.24|||||2-Sided|95.0|-13.32|0.84|||||||
1627164|NCT02187055|2988297|Superiority or Other||Difference in remission rate|2.61|||||2-Sided|95.0|-3.86|9.07|||||||
1627165|NCT02187055|2988297|Superiority or Other||Difference in remission rate|-6.89|||||2-Sided|95.0|-12.94|-0.83|||||||
1627166|NCT02187055|2988297|Superiority or Other||Difference in remission rate|-9.49|||||2-Sided|95.0|-15.68|-3.3|||||||
1627167|NCT02187055|2988298|Superiority or Other||Difference in remission rate|-0.47|||||2-Sided|95.0|-5.11|4.18|||||||
1627168|NCT02187055|2988298|Superiority or Other||Difference in remission rate|-2.02|||||2-Sided|95.0|-6.51|2.47|||||||
1627169|NCT02187055|2988298|Superiority or Other||Difference in remission rate|-1.55|||||2-Sided|95.0|-6.03|2.93|||||||
1627170|NCT02187055|2988299|Superiority or Other||Difference in remission rate|0.62|||||2-Sided|95.0|-4.24|5.47|||||||
1627171|NCT02187055|2988299|Superiority or Other||Difference in remission rate|-3.06|||||2-Sided|95.0|-7.59|1.48|||||||
1627172|NCT02187055|2988299|Superiority or Other||Difference in remission rate|-3.67|||||2-Sided|95.0|-8.29|0.94|||||||
1627173|NCT02187055|2988300|Superiority or Other||Difference in remission rate|0.34|||||2-Sided|95.0|-4.45|5.14|||||||
1627174|NCT02187055|2988300|Superiority or Other||Difference in remission rate|-3.06|||||2-Sided|95.0|-7.55|1.43|||||||
1627175|NCT02187055|2988300|Superiority or Other||Difference in remission rate|-3.4|||||2-Sided|95.0|-7.95|1.15|||||||
1627176|NCT02187055|2988301|Superiority or Other||Difference in remission rate|-0.56|||||2-Sided|95.0|-4.53|3.4|||||||
1627177|NCT02187055|2988301|Superiority or Other||Difference in remission rate|-1.78|||||2-Sided|95.0|-5.59|2.04|||||||
1627178|NCT02187055|2988301|Superiority or Other||Difference in remission rate|-1.21|||||2-Sided|95.0|-4.99|2.56|||||||
1627179|NCT02187055|2988302|Superiority or Other||LS mean difference|0.0|||||2-Sided|95.0|-0.23|0.13|||||||
1627180|NCT02187055|2988302|Superiority or Other||LS mean difference|0.3|||||2-Sided|95.0|0.1|0.46|||||||
1627181|NCT02187055|2988302|Superiority or Other||LS mean difference|0.3|||||2-Sided|95.0|0.15|0.51|||||||
1627182|NCT02187055|2988303|Superiority or Other||LS mean difference|-0.1|||||2-Sided|95.0|-0.28|0.06|||||||
1627183|NCT02187055|2988303|Superiority or Other||LS mean difference|0.2|||||2-Sided|95.0|0.05|0.39|||||||
1627184|NCT02187055|2988303|Superiority or Other||LS mean difference|0.3|||||2-Sided|95.0|0.16|0.5|||||||
1627185|NCT02187055|2988304|Superiority or Other||LS mean difference|-0.7|||||2-Sided|95.0|-2.24|0.86|||||||
1627186|NCT02187055|2988304|Superiority or Other||LS mean difference|1.9|||||2-Sided|95.0|0.4|3.48|||||||
1627187|NCT02187055|2988304|Superiority or Other||LS mean difference|2.6|||||2-Sided|95.0|1.08|4.18|||||||
1627188|NCT02187055|2988305|Superiority or Other||LS mean difference|-0.9|||||2-Sided|95.0|-2.51|0.68|||||||
1627189|NCT02187055|2988305|Superiority or Other||LS mean difference|1.9|||||2-Sided|95.0|0.33|3.49|||||||
1627190|NCT02187055|2988305|Superiority or Other||LS mean difference|2.8|||||2-Sided|95.0|1.23|4.41|||||||
1627191|NCT02187055|2988306|Non-Inferiority or Equivalence|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|2.23|||<|0.0001|2-Sided|98.34|-6.4|10.86|||Normal approximation to proportions|Multiplicity adjusted|||
1627192|NCT02187055|2988306|Non-Inferiority or Equivalence|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|-5.5|||<|0.0512|2-Sided|98.34|-13.98|2.98|||Normal approximation to proportions|Multiplicity-adjusted|||
1627193|NCT02187055|2988306|Non-Inferiority or Equivalence|Non-inferiority was a treatment difference larger than -13% at the population level|Difference in response rate|-7.73|||<|0.2101|2-Sided|98.34|-16.29|0.83|||Normal approximation to proportions|Multiplicity-adjusted|||
1627194|NCT02187029|2988332|Superiority or Other||LS Mean Difference|9.07|Standard Error of the Mean|1.86|||2-Sided|90.0|5.91|12.23||||||Day 14|
1627195|NCT02187029|2988332|Superiority or Other||LS Mean Difference|7.73|Standard Error of the Mean|1.86|||2-Sided|90.0|4.57|10.89||||||Day 7|
1627196|NCT02187029|2988332|Superiority or Other||LS Mean Difference|1.51|Standard Error of the Mean|1.64|||2-Sided|90.0|-1.29|4.31||||||Day 1|
1627197|NCT02187029|2988332|Superiority or Other||LS Mean Difference|3.59|Standard Error of the Mean|1.33|||2-Sided|90.0|1.33|5.85||||||Day 14|
1627198|NCT02187029|2988332|Superiority or Other||LS Mean Difference|2.91|Standard Error of the Mean|1.29|||2-Sided|90.0|0.71|5.11||||||Day 7|
1627199|NCT02187029|2988332|Superiority or Other||LS Mean Difference|0.9|Standard Error of the Mean|1.29|||2-Sided|90.0|-1.31|3.1||||||Day 1|
1627200|NCT02187029|2988333|Superiority or Other||LS Mean Difference|28.77|Standard Error of the Mean|1.48|||2-Sided|90.0|26.14|31.41||||||Day 14|
1627201|NCT02187029|2988333|Superiority or Other||LS Mean Difference|27.99|Standard Error of the Mean|1.4|||2-Sided|90.0|25.49|30.49||||||Day 7|
1627202|NCT02187029|2988333|Superiority or Other||LS Mean Difference|13.12|Standard Error of the Mean|2.0|||2-Sided|90.0|9.65|16.59||||||Day 1|
1627203|NCT02187029|2988333|Superiority or Other||LS Mean Difference|8.1|Standard Error of the Mean|1.03|||2-Sided|90.0|6.24|9.96||||||Day 14|
1627204|NCT02187029|2988333|Superiority or Other||LS Mean Difference|3.67|Standard Error of the Mean|0.94|||2-Sided|90.0|1.97|5.37||||||Day 7|
1627205|NCT02187029|2988333|Superiority or Other||LS Mean Difference|3.44|Standard Error of the Mean|1.57|||2-Sided|90.0|0.71|6.17||||||Day 1|
1627206|NCT02187029|2988334|Superiority or Other||LS Mean Difference|-29.83|Standard Error of the Mean|142.95|||2-Sided|90.0|-285.26|225.6||||||Day 14|
1627207|NCT02187029|2988334|Superiority or Other||LS Mean Difference|13.2|Standard Error of the Mean|125.47|||2-Sided|90.0|-208.07|234.47||||||Day 7|
1627208|NCT02187029|2988334|Superiority or Other||LS Mean Difference|433.21|Standard Error of the Mean|211.71|||2-Sided|90.0|58.3|808.13||||||Day 1|
1627209|NCT02187029|2988334|Superiority or Other||LS Mean Difference|107.96|Standard Error of the Mean|100.38|||2-Sided|90.0|-71.2|287.11||||||Day 14|
1627210|NCT02187029|2988334|Superiority or Other||LS Mean Difference|61.97|Standard Error of the Mean|88.27|||2-Sided|90.0|-94.87|218.82||||||Day 7|
1627211|NCT02187029|2988334|Superiority or Other||LS Mean Difference|316.89|Standard Error of the Mean|166.57|||2-Sided|90.0|21.91|611.88||||||Day 1|
1627212|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.223|Standard Error of the Mean|0.418|||2-Sided|90.0|-0.949|0.502||||||Follow-up, Day 25-29|
1627213|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.377|Standard Error of the Mean|0.247|||2-Sided|90.0|-0.047|0.802||||||Day 14, Hour 24|
1627214|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.406|Standard Error of the Mean|0.236|||2-Sided|90.0|0.0|0.812||||||Day 14, Hour 12|
1627215|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.088|Standard Error of the Mean|0.242|||2-Sided|90.0|-0.328|0.503||||||Day 14, Hour 8|
1627216|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.357|Standard Error of the Mean|0.247|||2-Sided|90.0|-0.069|0.782||||||Day 14, Hour 4|
1627217|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.53|Standard Error of the Mean|0.204|||2-Sided|90.0|0.172|0.888||||||Day 14, Hour 2|
1628209|NCT02160899|2990493|Superiority||||||<|0.001|||||||ANOVA||||
1627218|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.521|Standard Error of the Mean|0.213|||2-Sided|90.0|0.15|0.893||||||Day 14, Hour 1|
1627219|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.418|Standard Error of the Mean|0.215|||2-Sided|90.0|0.043|0.792||||||Day 14, pre-dose|
1627220|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.458|Standard Error of the Mean|0.256|||2-Sided|90.0|0.019|0.897||||||Day 7, Hour 24|
1627221|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.125|Standard Error of the Mean|0.256|||2-Sided|90.0|-0.564|0.315||||||Day 7, Hour 12|
1627222|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.254|Standard Error of the Mean|0.237|||2-Sided|90.0|-0.154|0.661||||||Day 7, Hour 8|
1627223|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.077|Standard Error of the Mean|0.26|||2-Sided|90.0|-0.523|0.368||||||Day 7, Hour 4|
1627224|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.396|Standard Error of the Mean|0.246|||2-Sided|90.0|-0.025|0.818||||||Day 7, Hour 2|
1627225|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.123|Standard Error of the Mean|0.31|||2-Sided|90.0|-0.41|0.656||||||Day 7, Hour 1|
1627226|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.206|Standard Error of the Mean|0.327|||2-Sided|90.0|-0.356|0.768||||||Day 7, pre-dose|
1627227|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.488|Standard Error of the Mean|0.299|||2-Sided|90.0|-0.024|1.0||||||Day 1, Hour 24|
1627228|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.283|Standard Error of the Mean|0.214|||2-Sided|90.0|-0.087|0.653||||||Day 1, Hour 12|
1627229|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.33|Standard Error of the Mean|0.256|||2-Sided|90.0|-0.107|0.768||||||Day 1, Hour 8|
1627230|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.091|Standard Error of the Mean|0.229|||2-Sided|90.0|-0.302|0.485||||||Day 1, Hour 4|
1627231|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.257|Standard Error of the Mean|0.26|||2-Sided|90.0|-0.193|0.707||||||Day 1, Hour 2|
1627232|NCT02187029|2988335|Superiority or Other||LS Mean Difference|0.05|Standard Error of the Mean|0.266|||2-Sided|90.0|-0.406|0.505||||||Day 1, Hour 1|
1627233|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.094|Standard Error of the Mean|0.339|||2-Sided|90.0|-0.683|0.496||||||Follow-up, Day 25-29|
1627234|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.317|Standard Error of the Mean|0.183|||2-Sided|90.0|-0.633|-0.002||||||Day 14, Hour 24|
1627235|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.163|Standard Error of the Mean|0.176|||2-Sided|90.0|-0.467|0.141||||||Day 14, Hour 12|
1627236|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.249|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.56|0.062||||||Day 14, Hour 8|
1627237|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.405|Standard Error of the Mean|0.184|||2-Sided|90.0|-0.722|-0.088||||||Day 14, Hour 4|
1627238|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.231|Standard Error of the Mean|0.155|||2-Sided|90.0|-0.504|0.043||||||Day 14, Hour 2|
1627239|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.152|Standard Error of the Mean|0.161|||2-Sided|90.0|-0.434|0.13||||||Day 14, Hour 1|
1627240|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.188|Standard Error of the Mean|0.162|||2-Sided|90.0|-0.472|0.097||||||Day 14, pre-dose|
1627241|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.125|Standard Error of the Mean|0.186|||2-Sided|90.0|-0.445|0.196||||||Day 7, Hour 24|
1627242|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.13|Standard Error of the Mean|0.186|||2-Sided|90.0|-0.451|0.191||||||Day 7, Hour 12|
1627243|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.207|Standard Error of the Mean|0.174|||2-Sided|90.0|-0.508|0.095||||||Day 7, Hour 8|
1627244|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.083|Standard Error of the Mean|0.189|||2-Sided|90.0|-0.408|0.242||||||Day 7, Hour 4|
1627245|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.082|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.392|0.228||||||Day 7, Hour 2|
1627246|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.08|Standard Error of the Mean|0.221|||2-Sided|90.0|-0.46|0.299||||||Day 7, Hour 1|
1627247|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.263|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.657|0.132||||||Day 7, pre-dose|
1627248|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.166|Standard Error of the Mean|0.235|||2-Sided|90.0|-0.569|0.237||||||Day 1, Hour 24|
1627249|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.284|Standard Error of the Mean|0.168||||90.0|-0.575|0.006||||||Day 1, Hour 12|
1627250|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.046|Standard Error of the Mean|0.201||||90.0|-0.39|0.298||||||Day 1, Hour 8|
1627251|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.258|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.568|0.052||||||Day 1, Hour 4|
1627252|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.179|Standard Error of the Mean|0.205|||2-Sided|90.0|-0.533|0.175||||||Day 1, Hour 2|
1627253|NCT02187029|2988335|Superiority or Other||LS Mean Difference|-0.348|Standard Error of the Mean|0.209|||2-Sided|90.0|-0.707|0.01||||||Day 1, Hour 1|
1627254|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.8565|Standard Error of the Mean|0.4796|||2-Sided|90.0|0.0017|1.7112||||||Follow-up, Day 25-29|
1627255|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.1465|Standard Error of the Mean|0.0615|||2-Sided|90.0|0.0361|0.2569||||||Day 14, Hour 24|
1627256|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.1982|Standard Error of the Mean|0.0577|||2-Sided|90.0|0.0945|0.3019||||||Day 14, Hour 12|
1627257|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.2814|Standard Error of the Mean|0.0627|||2-Sided|90.0|0.1688|0.394||||||Day 14, Hour 8|
1627258|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.5807|Standard Error of the Mean|0.07|||2-Sided|90.0|0.4549|0.7065||||||Day 14, Hour 4|
1627259|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.5631|Standard Error of the Mean|0.0724|||2-Sided|90.0|0.433|0.6932||||||Day 14, Hour 2|
1627260|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.3524|Standard Error of the Mean|0.0477|||2-Sided|90.0|0.2667|0.438||||||Day 14, Hour 1|
1627261|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.166|Standard Error of the Mean|0.0377|||2-Sided|90.0|0.0982|0.2338||||||Day 14, pre-dose|
1627262|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.1708|Standard Error of the Mean|0.0486|||2-Sided|90.0|0.0841|0.2574||||||Day 7, Hour 24|
1627263|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.0216|Standard Error of the Mean|0.0368|||2-Sided|90.0|-0.0439|0.0872||||||Day 7, Hour 12|
1627264|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.3857|Standard Error of the Mean|0.0512|||2-Sided|90.0|0.2944|0.4769||||||Day 7, Hour 8|
1627265|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.5235|Standard Error of the Mean|0.0675|||2-Sided|90.0|0.4032|0.6438||||||Day 7, Hour 4|
1627266|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.5409|Standard Error of the Mean|0.0729|||2-Sided|90.0|0.411|0.6707||||||Day 7, Hour 2|
1627267|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.1953|Standard Error of the Mean|0.0747||||90.0|0.0625|0.3281||||||Day 7, Hour 1|
1627268|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.1303|Standard Error of the Mean|0.083|||2-Sided|90.0|-0.0172|0.2778||||||Day 7, pre-dose|
1627269|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.168|Standard Error of the Mean|0.0702|||2-Sided|90.0|0.0436|0.2924||||||Day 1, Hour 24|
1627270|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.1462|Standard Error of the Mean|0.0467|||2-Sided|90.0|0.0635|0.2289||||||Day 1, Hour 12|
1627271|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.2841|Standard Error of the Mean|0.0563|||2-Sided|90.0|0.1843|0.3838||||||Day 1, Hour 8|
1627272|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.3812|Standard Error of the Mean|0.0536|||2-Sided|90.0|0.2862|0.4762||||||Day 1, Hour 4|
1627273|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.3845|Standard Error of the Mean|0.0802|||2-Sided|90.0|0.2424|0.5266||||||Day 1, Hour 2|
1627274|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.1175|Standard Error of the Mean|0.0537|||2-Sided|90.0|0.0223|0.2127||||||Day 1, Hour 1|
1627275|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.4011|Standard Error of the Mean|0.3916|||2-Sided|90.0|-0.2968|1.099||||||Follow-up, Day 25-29|
1627276|NCT02187029|2988336|Superiority or Other||LS Mean Difference|-0.0413|Standard Error of the Mean|0.0433|||2-Sided|90.0|-0.1192|0.0365||||||Day 14, Hour 24|
1627277|NCT02187029|2988336|Superiority or Other||LS Mean Difference|-0.0186|Standard Error of the Mean|0.0408|||2-Sided|90.0|-0.0918|0.0547||||||Day 14, Hour 12|
1627278|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.0124|Standard Error of the Mean|0.0443|||2-Sided|90.0|-0.0672|0.0919||||||Day 14, Hour 8|
1627279|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.0062|Standard Error of the Mean|0.0495|||2-Sided|90.0|-0.0827|0.0952||||||Day 14, Hour 4|
1627280|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.1025|Standard Error of the Mean|0.0512|||2-Sided|90.0|0.0104|0.1945||||||Day 14, Hour 2|
1627281|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.0616|Standard Error of the Mean|0.0337|||2-Sided|90.0|0.001|0.1222||||||Day 14, Hour 1|
1627282|NCT02187029|2988336|Superiority or Other||LS Mean Difference|-0.0167|Standard Error of the Mean|0.0268|||2-Sided|90.0|-0.0649|0.0315||||||Day 14, pre-dose|
1627283|NCT02187029|2988336|Superiority or Other||LS Mean Difference|-0.0298|Standard Error of the Mean|0.0331|||2-Sided|90.0|-0.0889|0.0292||||||Day 7, Hour 24|
1627284|NCT02187029|2988336|Superiority or Other||LS Mean Difference|-0.0526|Standard Error of the Mean|0.0251|||2-Sided|90.0|-0.0973|-0.0079||||||Day 7, Hour 12|
1627285|NCT02187029|2988336|Superiority or Other||LS Mean Difference|-0.0244|Standard Error of the Mean|0.0349|||2-Sided|90.0|-0.0865|0.0378||||||Day 7, Hour 8|
1627286|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.0086|Standard Error of the Mean|0.0459|||2-Sided|90.0|-0.0733|0.0905||||||Day 7, Hour 4|
1627287|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.033|Standard Error of the Mean|0.0496|||2-Sided|90.0|-0.0554|0.1213||||||Day 7, Hour 2|
1627288|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.0109|Standard Error of the Mean|0.0506|||2-Sided|90.0|-0.0793|0.101||||||Day 7, Hour 1|
1627289|NCT02187029|2988336|Superiority or Other||LS Mean Difference|-0.0539|Standard Error of the Mean|0.0561|||2-Sided|90.0|-0.1538|0.046||||||Day 7, pre-dose|
1627290|NCT02187029|2988336|Superiority or Other||LS Mean Difference|-0.008|Standard Error of the Mean|0.0553|||2-Sided|90.0|-0.1058|0.0899||||||Day 1, Hour 24|
1627291|NCT02187029|2988336|Superiority or Other||LS Mean Difference|-0.0502|Standard Error of the Mean|0.0367|||2-Sided|90.0|-0.1153|0.0149||||||Day 1, Hour 12|
1627292|NCT02187029|2988336|Superiority or Other||LS Mean Difference|0.0035|Standard Error of the Mean|0.0443|||2-Sided|90.0|-0.075|0.082||||||Day 1, Hour 8|
1627293|NCT02187029|2988336|Superiority or Other||LS Mean Difference|-0.0331|Standard Error of the Mean|0.0422|||2-Sided|90.0|-0.1078|0.0417||||||Day 1, Hour 4|
1627294|NCT02187029|2988336|Superiority or Other||LS Mean Difference|-0.0152|Standard Error of the Mean|0.0631|||2-Sided|90.0|-0.1269|0.0966||||||Day 1, Hour 2|
1627295|NCT02187029|2988336|Superiority or Other||LS Mean Difference|-0.0355|Standard Error of the Mean|0.0423|||2-Sided|90.0|-0.1103|0.0394||||||Day 1, Hour 1|
1627296|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-2.66|Standard Error of the Mean|1.26|||2-Sided|90.0|-4.96|-0.35||||||Follow-up, Day 25-29|
1627297|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-5.77|Standard Error of the Mean|0.38|||2-Sided|90.0|-6.47|-5.07||||||Day 14, Hour 24|
1627298|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-6.4|Standard Error of the Mean|0.42|||2-Sided|90.0|-7.18|-5.63||||||Day 14, Hour 12|
1627299|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-6.64|Standard Error of the Mean|0.42|||2-Sided|90.0|-7.41|-5.87||||||Day 14, Hour 8|
1627300|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-6.42|Standard Error of the Mean|0.33|||2-Sided|90.0|-7.03|-5.81||||||Day 14, Hour 4|
1627301|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-6.14|Standard Error of the Mean|0.41|||2-Sided|90.0|-6.9|-5.38||||||Day 14, Hour 2|
1627302|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-5.96|Standard Error of the Mean|0.39|||2-Sided|90.0|-6.67|-5.24||||||Day 14, Hour 1|
1627303|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-5.76|Standard Error of the Mean|0.36|||2-Sided|90.0|-6.42|-5.1||||||Day 14, pre-dose|
1627304|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-5.62|Standard Error of the Mean|0.53|||2-Sided|90.0|-6.59|-4.65||||||Day 11|
1627305|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-5.75|Standard Error of the Mean|0.42|||2-Sided|90.0|-6.5|-4.99||||||Day 7, Hour 24|
1627306|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-6.24|Standard Error of the Mean|0.44|||2-Sided|90.0|-7.03|-5.44||||||Day 7, Hour 12|
1628210|NCT02160899|2990493|Superiority||||||<|0.001|||||||ANOVA||||
1627307|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-6.29|Standard Error of the Mean|0.43|||2-Sided|90.0|-7.07|-5.51||||||Day 7, Hour 8|
1627308|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-6.51|Standard Error of the Mean|0.53|||2-Sided|90.0|-7.46|-5.55||||||Day 7, Hour 4|
1627309|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-6.18|Standard Error of the Mean|0.55|||2-Sided|90.0|-7.17|-5.19||||||Day 7, Hour 2|
1627310|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-5.84|Standard Error of the Mean|0.49|||2-Sided|90.0|-6.72|-4.95||||||Day 7, Hour 1|
1627311|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-5.81|Standard Error of the Mean|0.45|||2-Sided|90.0|-6.62|-5.0||||||Day 7, pre-dose|
1627312|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-4.76|Standard Error of the Mean|0.29|||2-Sided|90.0|-5.29|-4.23||||||Day 3|
1627313|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-3.47|Standard Error of the Mean|0.26||||90.0|-3.94|-3.0||||||Day 1, Hour 24|
1627314|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-3.84|Standard Error of the Mean|0.24|||2-Sided|90.0|-4.28|-3.4||||||Day 1, Hour 12|
1627315|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-3.7|Standard Error of the Mean|0.37|||2-Sided|90.0|-4.36|-3.03||||||Day 1, Hour 8|
1627316|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-2.91|Standard Error of the Mean|0.12|||2-Sided|90.0|-3.14|-2.69||||||Day 1, Hour 4|
1627317|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-1.18|Standard Error of the Mean|0.24|||2-Sided|90.0|-1.61|-0.75||||||Day 1, Hour 2|
1627318|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-0.62|Standard Error of the Mean|0.17|||2-Sided|90.0|-0.92|-0.32||||||Day 1, Hour 1|
1627319|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-1.09|Standard Error of the Mean|1.03|||2-Sided|90.0|-2.97|0.79||||||Follow-up, Day 25-29|
1627320|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-4.65|Standard Error of the Mean|0.25|||2-Sided|90.0|-5.12|-4.18||||||Day 14, Hour 24|
1627321|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-5.34|Standard Error of the Mean|0.28|||2-Sided|90.0|-5.86|-4.82||||||Day 14, Hour 12|
1627322|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-5.57|Standard Error of the Mean|0.28|||2-Sided|90.0|-6.08|-5.05||||||Day 14, Hour 8|
1627323|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-5.43|Standard Error of the Mean|0.22|||2-Sided|90.0|-5.83|-5.02||||||Day 14, Hour 4|
1627324|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-4.97|Standard Error of the Mean|0.27|||2-Sided|90.0|-5.47|-4.47||||||Day 14, Hour 2|
1627325|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-4.55|Standard Error of the Mean|0.25|||2-Sided|90.0|-5.02|-4.08||||||Day 14, Hour 1|
1627326|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-4.32|Standard Error of the Mean|0.23|||2-Sided|90.0|-4.75|-3.88||||||Day 14, pre-dose|
1627327|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-4.56|Standard Error of the Mean|0.35|||2-Sided|90.0|-5.19|-3.92||||||Day 11|
1627328|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-2.81|Standard Error of the Mean|0.27|||2-Sided|90.0|-3.3|-2.32||||||Day 7, Hour 24|
1627329|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-3.2|Standard Error of the Mean|0.28|||2-Sided|90.0|-3.72|-2.68||||||Day 7, Hour 12|
1627330|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-3.3|Standard Error of the Mean|0.28|||2-Sided|90.0|-3.82|-2.79||||||Day 7, Hour 8|
1627331|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-3.4|Standard Error of the Mean|0.35|||2-Sided|90.0|-4.03|-2.77||||||Day7, Hour 4|
1627332|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-3.06|Standard Error of the Mean|0.36|||2-Sided|90.0|-3.72|-2.41||||||Day 7, Hour 2|
1627333|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-2.8|Standard Error of the Mean|0.33|||2-Sided|90.0|-3.39|-2.21||||||Day 7, Hour 1|
1627334|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-2.75|Standard Error of the Mean|0.3|||2-Sided|90.0|-3.29|-2.2||||||Day 7, pre-dose|
1627335|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-2.48|Standard Error of the Mean|0.23|||2-Sided|90.0|-2.89|-2.06||||||Day 3|
1627336|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-1.74|Standard Error of the Mean|0.2|||2-Sided|90.0|-2.11|-1.37||||||Day 1, Hour 24|
1627337|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-1.83|Standard Error of the Mean|0.19|||2-Sided|90.0|-2.18|-1.48||||||Day 1, Hour 12|
1627338|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-1.86|Standard Error of the Mean|0.29|||2-Sided|90.0|-2.38|-1.33||||||Day 1, Hour 8|
1627339|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-1.34|Standard Error of the Mean|0.1|||2-Sided|90.0|-1.52|-1.16||||||Day 1, Hour 4|
1627340|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-0.62|Standard Error of the Mean|0.19|||2-Sided|90.0|-0.95|-0.28||||||Day 1, Hour 2|
1627341|NCT02187029|2988342|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.13||||90.0|-0.55|-0.06||||||Day 1, Hour 1|
1627342|NCT02187029|2988347|Superiority or Other||Mean Difference (Final Values)|-66.31|||||2-Sided|90.0|-71.31|-61.54|||||||
1627343|NCT02187029|2988347|Superiority or Other||Mean Difference (Final Values)|-52.55|||||2-Sided|90.0|-56.32|-48.78|||||||
1627344|NCT02186873|2988362|Superiority or Other||Difference in Percentage|47.1|||<|0.001|2-Sided|95.0|35.18|58.99|||Cochran-Mantel-Haenszel||||
1627345|NCT02186808|2988370|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1627346|NCT02186301|2988393|Other||Kaplan Meier Median|335.0|||||2-Sided|95.0|282.0|480.0|||||||
1627347|NCT02186301|2988393|Other||Kaplan Meier Median|195.5|||||2-Sided|95.0|143.0|617.0|||||||
1627348|NCT02186301|2988393|Other||Kaplan Meier Median|225.0|||||2-Sided|95.0|113.0||Upper Confidence Limit is not available because it cannot be calculated.||||||
1627349|NCT02186301|2988394|Other||Percentage|78.0|||||2-Sided|95.0|64.0|88.5|||||||
1627350|NCT02186301|2988394|Other||Percentage|40.0|||||2-Sided|95.0|22.7|59.4|||||||
1627351|NCT02186301|2988394|Other||Percentage|25.0|||||2-Sided|95.0|8.7|49.1|||||||
1627352|NCT02186301|2988395|Other||Kaplan Meier Median|390.0|||||2-Sided|95.0|282.0|499.0|||||||
1627354|NCT02186301|2988395|Other||Kaplan-Meier Median|274.0|||||2-Sided|95.0|109.0||Upper Confidence Limit is not available because it cannot be calculated||||||
1627355|NCT02186171|2988404|Superiority|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|1.3|Standard Error of the Mean|0.4|=|0|2-Sided|95.0|0.4|2.1||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA||||
1627356|NCT02186171|2988405|Superiority|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|1.4|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|0.8|2.0||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA||||
1627357|NCT02186171|2988406|Superiority|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 6 months at the lumbar spine, total hip and femoral neck BMD in order to maintain the overall significance level at 0.05.|LS Mean Difference|8.7|Standard Error of the Mean|0.5|<|0.0001|2-Sided|95.0|7.6|9.7||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA||||
1627358|NCT02186171|2988407|Superiority|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.|LS Mean Difference|2.4|Standard Error of the Mean|0.5|<|0.0001|2-Sided|95.0|1.5|3.3||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA||||
1627359|NCT02186171|2988408|Superiority|The Hochberg procedure was employed to control the overall type 1 error for the percent change from baseline at 12 months in total hip and femoral neck to maintain the overall significance level at 0.05.|LS Mean Difference|3.0|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|2.3|3.7||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA||||
1627360|NCT02186171|2988409|Superiority||LS Mean Difference|10.9|Standard Error of the Mean|0.6|<|0.0001|2-Sided|95.0|9.6|12.2||ANCOVA model adjusting for treatment, baseline BMD value, machine type, machine type-by-baseline BMD value, baseline testosterone level, geographic region, and using a variance structure allowing for heterogeneity between treatment groups.|ANCOVA||||
1627361|NCT02185534|2988413|Non-Inferiority or Equivalence|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Geometric mean ratio|92.03|||||2-Sided|90.0|84.91|99.75|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel||
1627362|NCT02185534|2988413|Non-Inferiority or Equivalence|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|93.94|||||2-Sided|90.0|87.12|101.29|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel||
1627363|NCT02185534|2988414|Non-Inferiority or Equivalence|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|105.79|||||2-Sided|90.0|95.22|117.53|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel||
1627364|NCT02185534|2988414|Non-Inferiority or Equivalence|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25.|Geometric mean ratio|108.06|||||2-Sided|90.0|95.46|122.33|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel||
1627365|NCT02185534|2988415|Non-Inferiority or Equivalence|Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|Geometric mean ratio|97.19|||||2-Sided|90.0|81.12|116.45|||||Geometric mean ratio is calculated as A/C, where A= European clopidogrel and C=US clopidogrel|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|
1627366|NCT02185534|2988415|Non-Inferiority or Equivalence|The analysis was conducted using an analysis of variance (ANOVA) including fixed effects for treatment, sequence, period and subject within sequence. All pharmacokinetic parameters were log-transformed prior to analysis. Bioequivalence was concluded, when the 90% confidence interval (CI) for the geometric LS mean ratios were fully contained within the predefined equivalence limits of 0.80 to 1.25|Geometric mean ratio|104.43|||||2-Sided|90.0|92.27|118.19|||||Geometric mean ratio is calculated as A/B, where A= European clopidogrel and B=Japanese clopidogrel||
1627367|NCT02184624|2988469|Superiority or Other||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device by the ‘ease of use’ questionnaire|Cochran-Mantel-Haenszel||||
1627368|NCT02184624|2988469|Superiority or Other||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device by the ‘ease of use’ questionnaire|Cochran-Mantel-Haenszel||||
1627369|NCT02184624|2988469|Superiority or Other||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device by the ‘ease of use’ questionnaire|Cochran-Mantel-Haenszel||||
1627370|NCT02184624|2988469|Superiority or Other||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring MDI device by the ‘ease of use’ questionnaire|Cochran-Mantel-Haenszel||||
1627371|NCT02184624|2988469|Superiority or Other||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device by the ‘ease of use’ questionnaire|Cochran-Mantel-Haenszel||||
1627372|NCT02184624|2988470|Superiority or Other||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring BREEZHALER device as assessed by the ‘preference’ questionnaire|Cochran-Mantel-Haenszel||||
1627373|NCT02184624|2988470|Superiority or Other||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring HANDIHALER device as assessed by the ‘preference’ questionnaire|Cochran-Mantel-Haenszel||||
1627374|NCT02184624|2988470|Superiority or Other||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring TURBUHALER device as assessed by the ‘preference’ questionnaire|Cochran-Mantel-Haenszel||||
1627375|NCT02184624|2988470|Superiority or Other||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring MDI device as assessed by the ‘preference’ questionnaire|Cochran-Mantel-Haenszel||||
1627376|NCT02184624|2988470|Superiority or Other||||||<|0.001||||||Number of participants preferring ELLIPTA device versus number of participants preferring DISKUS/ACCUHALER device as assessed by the ‘preference’ questionnaire|Cochran-Mantel-Haenszel||||
1627377|NCT02184624|2988471|Superiority or Other||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for BREEZHALER inhaler|Wilcoxon signed rank test||||
1627378|NCT02184624|2988471|Superiority or Other||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for HANDIHALER inhaler|Wilcoxon signed rank test||||
1627379|NCT02184624|2988471|Superiority or Other||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for TURBUHALER inhaler|Wilcoxon signed rank test||||
1627380|NCT02184624|2988471|Superiority or Other||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for MDI inhaler|Wilcoxon signed rank test||||
1627381|NCT02184624|2988471|Superiority or Other||||||<|0.001||||||Number of participants requiring instructions from the HCP (maximum three times) to demonstrate adequate inhalation technique of ELLIPTA inhaler versus those for DISKUS/ACCUHALER inhaler|Wilcoxon signed rank test||||
1627382|NCT02184624|2988472|Superiority or Other|||||||0.003||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel||||
1627383|NCT02184624|2988472|Superiority or Other|||||||0.001||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel||||
1627384|NCT02184624|2988472|Superiority or Other|||||||0.002||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel||||
1627385|NCT02184624|2988472|Superiority or Other||||||<|0.001||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel||||
1627386|NCT02184624|2988472|Superiority or Other||||||<|0.001||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel||||
1627387|NCT02184624|2988473|Superiority or Other|||||||0.014||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel||||
1627388|NCT02184624|2988473|Superiority or Other||||||<|0.001||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel||||
1627389|NCT02184624|2988473|Superiority or Other||||||<|0.025||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel||||
1627390|NCT02184624|2988473|Superiority or Other||||||<|0.044||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel||||
1627391|NCT02184624|2988473|Superiority or Other||||||<|0.48||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel||||
1627392|NCT02184624|2988474|Superiority or Other||||||<|0.001||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel||||
1627393|NCT02184624|2988474|Superiority or Other||||||<|0.001||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel||||
1627394|NCT02184624|2988474|Superiority or Other||||||<|0.001||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel||||
1627395|NCT02184624|2988474|Superiority or Other||||||<|0.001||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel||||
1627396|NCT02184624|2988474|Superiority or Other||||||<|0.001||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel||||
1627397|NCT02184624|2988475|Superiority or Other||||||<|0.001||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using BREEZHALER|Cochran-Mantel-Haenszel||||
1627398|NCT02184624|2988475|Superiority or Other||||||<|0.001||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using HANDIHALER|Cochran-Mantel-Haenszel||||
1627399|NCT02184624|2988475|Superiority or Other||||||<|0.001||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using TURBUHALER|Cochran-Mantel-Haenszel||||
1627400|NCT02184624|2988475|Superiority or Other||||||<|0.001||||||Statistical comparison for categories: Error while using only ELLIPTA inhaler Vs Error while using MDI|Cochran-Mantel-Haenszel||||
1627401|NCT02184624|2988475|Superiority or Other||||||<|0.001||||||Statistical comparison for categories Error while using only ELLIPTA inhaler Vs Error while using DISKUS/ACCUHALER|Cochran-Mantel-Haenszel||||
1627402|NCT02184611|2988478|Other||Least square mean difference|-0.68||||0.386|2-Sided|95.0|-2.22|0.86||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 128, UMEC Vs Placebo.|
1627403|NCT02184611|2988478|Other||Least square mean difference|-2.1||||0.004|2-Sided|95.0|-3.51|-0.68||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 84, UMEC Vs Placebo.|
1627404|NCT02184611|2988478|Other||Least sqaure mean difference|-1.49||||0.027|2-Sided|95.0|-2.81|-0.17||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 28, UMEC Vs Placebo.|
1627405|NCT02184611|2988479|Other||Least sqaure mean difference|-3.03||||0.058|2-Sided|95.0|-6.15|0.1||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 168, UMEC Vs Placebo.|
1627406|NCT02184611|2988479|Other||Least square mean difference|-4.59||||0.003|2-Sided|95.0|-7.61|-1.57||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 84, UMEC Vs Placebo.|
1627407|NCT02184611|2988479|Other||Least sqaure mean difference|-4.39||||0.002|2-Sided|95.0|-7.21|-1.58||Analysis performed using a repeated measures model with covariates of treatment, Baseline (score prior to dosing on Day 1), smoking status, country, Day, Day by Baseline and Day by treatment interactions.|MMRM|||Day 28, UMEC Vs Placebo.|
1627408|NCT02184611|2988488|Other||Least square Mean difference|0.125|||<|0.001|2-Sided|95.0|0.103|0.147||Analysis performed using an analysis of covariance (ANCOVA) model with covariates of treatment, baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status and country.|ANCOVA|||UMEC versus Placebo.|
1627409|NCT02184611|2988489|Other||Least square Mean difference|0.9||||0.004|2-Sided|95.0|0.3|1.5||Analysis performed using a MMRM model with covariates of treatment, BDI focal score, smoking status, country, Day, Day by BDI focal score and Day by treatment interactions.|MMRM|||UMEC versus Placebo.|
1627410|NCT02184611|2988490|Other||Least square mean difference|0.154|||<|0.001|2-Sided|95.0|0.113|0.194||Analysis was performed using a MMRM model with covariates of treatment, Baseline, smoking status, country, Day, Day by Baseline and Day by treatment interactions.|Mixed Models Repeated Measures (MMRM)|||UMEC versus Placebo.|
1627411|NCT02184572|2988506|Non-Inferiority or Equivalence|The upper limit of the 2-sided standardised asymptotic 95% CI for the group difference (INV_MMR minus COM_MMR) in incidence of fever ≥ 38.0°C (≥ 100.4°F) should be equal to or below 10%.|Difference in incidence of fever|1.09|||||2-Sided|95.0|-2.89|4.85||||||Difference between groups (INV_MMR Group minus COM_MMR Group) in incidence of fever > 38.0°C.|
1627412|NCT02184572|2988506|Non-Inferiority or Equivalence|The upper limit of the 2-sided standardised asymptotic 95% Confidence Interval (CI) for the group difference (INV_MMR minus COM_MMR) in incidence of fever ≥ 39.0°C (≥ 102.2°F) should be equal to or below 5%.|Difference in incidence of fever|1.11|||||2-Sided|95.0|-0.93|2.89||||||Difference between groups (INV_MMR Group minus COM_MMR Group) in incidence of fever > 39.0°C.|
1627413|NCT02184195|2988524|Superiority||Mean Difference (Final Values)|-2.47||||0.31|2-Sided|95.0|-7.267|2.327|||Mixed Models Analysis||||
1627414|NCT02184195|2988526|Superiority||Odds Ratio (OR)|2.3||||0.1028|2-Sided|95.0|0.886|6.761|||Regression, Logistic||||
1627415|NCT02184195|2988527|Superiority||Hazard Ratio (HR)|0.446||||0.0001|2-Sided|95.0|0.297|0.67|||Log-rank test||||
1627416|NCT02184195|2988528|Superiority||Hazard Ratio (HR)|0.496||||0.0013|2-Sided|95.0|0.324|0.76|||Log-rank test||||
1627417|NCT02184195|2988529|Superiority||Hazard Ratio (HR)|0.678||||0.0825|2-Sided|95.0|0.437|1.051|||Log-rank test||||
1627418|NCT02184195|2988530|Superiority||Hazard Ratio (HR)|0.755||||0.2597|2-Sided|95.0|0.464|1.23|||Log-rank test||||
1627419|NCT02184195|2988531|Other||Hazard Ratio (HR)|0.906||||0.6833|2-Sided|95.0|0.563|1.457|||Log-rank test||||
1627420|NCT02184195|2988532|Superiority||Hazard Ratio (HR)|0.531||||0.0038|2-Sided|95.0|0.346|0.815|||Log-rank test||||
1627421|NCT02183675|2988557|Non-Inferiority or Equivalence|Non-inferiority limits: 80% − 125%|Adjusted geometric mean ratio (%)|103.39|Standard Error of the Mean|1.028|||2-Sided|90.0|98.73|108.28|||||Ratio calculated as T80-A5-H12.5 divided by T80-H12.5||
1627422|NCT02183675|2988558|Non-Inferiority or Equivalence|Non-inferiority limits: 80% − 125%|Adjusted geometric mean ratio (%)|105.35|Standard Error of the Mean|1.036|||2-Sided|90.0|99.23|111.847|||||Ratio calculated as T80-A5-H12.5 divided by T80-H12.5||
1627423|NCT02183675|2988559|Non-Inferiority or Equivalence|Non-inferiority limits: 80% − 125%|Adjusted geometric mean ratio (%)|102.49|Standard Error of the Mean|1.014|||2-Sided|90.0|100.167|104.867|||||Ratio calculated as T80-A5-H12.5 divided by T80-A5||
1627424|NCT02183675|2988560|Non-Inferiority or Equivalence|Non-inferiority limits: 80% − 125%|Adjusted geometric mean ratio (%)|103.95|Standard Error of the Mean|1.017|||2-Sided|90.0|101.023|106.964|||||Ratio calculated as T80-A5-H12.5 divided by T80-A5||
1627425|NCT02183675|2988561|Non-Inferiority or Equivalence|Non-inferiority limits: 80% − 125%|Adjusted geometric mean ratio (%)|104.8|Standard Error of the Mean|1.016|||2-Sided|90.0|101.949|107.734|||||Ratio calculated as T80-A5-H12.5 divided by T80-H12.5||
1627426|NCT02183675|2988562|Non-Inferiority or Equivalence|Non-inferiority limits: 80% − 125%|Adjusted geometric mean ratio (%)|102.04|Standard Error of the Mean|1.03|||2-Sided|90.0|96.94|107.4|||||Ratio calculated as T80-A5-H12.5 divided by T80-A5||
1627488|NCT02179047|2988885|Superiority||Hazard Ratio (HR)|1.39|Standard Deviation|0.005||0.001|2-Sided||||||ANCOVA||||
1627427|NCT02183675|2988562|Non-Inferiority or Equivalence|Non-inferiority limits: 80% − 125%|Adjusted geometric mean ratio (%)|97.53|Standard Error of the Mean|1.05|||2-Sided|90.0|90.43|105.19|||||Ratio calculated as T80-A5-H12.5 divided by T80-H12.5||
1627428|NCT02183675|2988563|Non-Inferiority or Equivalence|Non-inferiority limits: 80% − 125%|Adjusted geometric mean ratio (%)|114.86|Standard Error of the Mean|1.097|||2-Sided|90.0|98.216|134.326|||||Ratio calculated as T80-A5-H12.5 divided by T80-A5||
1627429|NCT02183675|2988563|Non-Inferiority or Equivalence|Non-inferiority limits: 80% − 125%|Adjusted geometric mean ratio (%)|108.39|Standard Error of the Mean|1.094|||2-Sided|90.0|93.081|126.225|||||Ratio calculated as T80-A5-H12.5 divided by T80-H12.5||
1627430|NCT02182999|2988568|Superiority||Mean Difference (Final Values)|0.4||||0.353|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1627431|NCT02182999|2988569|Superiority||Mean Difference (Final Values)|0.1||||0.596|2-Sided||||||Wilcoxon (Mann-Whitney)|||A sample size of 17 patients in each group was previously calculated on the basis of a significance level of .05, a power of 80%, an anticipated pooled standard Deviation (SD) of 1.0 of the mean verbal NRS pain level, and a minimal clinically important difference in the mean verbal NRS pain level of 1.0 points between the groups. Anticipating a loss to follow-up, we planned to recruit a total of 50 patients (25 patients each group).|
1627432|NCT02182973|2988570|Superiority|||||||0.025|||||||t-test, 2 sided||||
1627433|NCT02182973|2988571|Superiority|||||||0.875|||||||t-test, 2 sided||||
1627434|NCT02182973|2988572|Superiority|||||||0.001|||||||t-test, 2 sided||||
1627435|NCT02182830|2988583|Superiority||Adjusted mean difference|-4.25|Standard Error of the Mean|1.49||0.0053|2-Sided|95.0|-7.21|-1.29|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.|
1627436|NCT02182830|2988584|Superiority||Adjusted mean difference|-1.84|Standard Error of the Mean|1.56||0.2402|2-Sided|95.0|-4.93|1.25|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.|
1627437|NCT02182830|2988585|Superiority||Adjusted mean difference|-7.43|Standard Error of the Mean|2.5||0.0036|2-Sided|95.0|-12.37|-2.48|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.|
1627438|NCT02182830|2988586|Superiority||Adjusted mean difference|-4.91|Standard Error of the Mean|1.74||0.0058|2-Sided|95.0|-8.35|-1.46|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.|
1627439|NCT02182830|2988587|Superiority||Adjusted mean difference|-3.43|Standard Error of the Mean|1.25||0.0069|2-Sided|95.0|-5.9|-0.96|||ANCOVA||Empagliflozin minus Placebo|The respective ANCOVA model includes treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the respective secondary endpoint.|
1627440|NCT02182830|2988588|Superiority||Adjusted mean difference|-8.39|Standard Error of the Mean|2.69||0.0025|2-Sided|95.0|-13.74|-3.04|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the secondary endpoint with continuous baseline HbA1c, continuous baseline secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline secondary endpoint.|
1627441|NCT02182830|2988589|Superiority|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-4.04|Standard Error of the Mean|2.59||0.1215|2-Sided|95.0|-9.16|1.09|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.|
1627442|NCT02182830|2988590|Superiority|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-1.23|Standard Error of the Mean|0.59||0.0382|2-Sided|95.0|-2.39|-0.07|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM models modelling the key secondary endpoint with continuous baseline HbA1c, continuous baseline key secondary endpoint, treatment, renal function, pretreatment with metformin, visit, visit by treatment interaction, visit by continuous baseline HbA1c interaction, visit by continuous baseline key secondary endpoint.|
1627443|NCT02182830|2988591|Superiority|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-5.99|Standard Error of the Mean|2.62||0.0237|2-Sided|95.0|-11.16|-0.81|||ANCOVA||Empagliflozin minus Placebo|"ANCOVA mode:~The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint."|
1627444|NCT02182830|2988592|Superiority|A hierarchical multiple testing procedure was used to evaluate superiority of the endpoint|Adjusted mean difference|-5.21|Standard Error of the Mean|2.04||0.0117|2-Sided|95.0|-9.24|-1.18|||ANCOVA||Empagliflozin minus Placebo|"change from baseline in mean 24-hour ambulatory SBP at 12 weeks of treatment was evaluated by using an Analysis of Covariance (ANCOVA) model.~The respective model included treatment, renal function, pretreatment with metformin, continuous baseline HbA1c, and continuous baseline of the endpoint."|
1627484|NCT02179398|2988870|Superiority or Other|||||||0.81|||||||Chi-squared|||Power calculation suggested 97 patients should be enrolled in each group to give 80% power at the 5% level of significance to detect a 20% difference in antibiotic prescription rate|
1627485|NCT02179398|2988871|Superiority or Other|||||||1|||||||Chi-squared||||
1627486|NCT02179398|2988872|Superiority or Other|||||||1|||||||Chi-squared||||
1627487|NCT02179177|2988884|Other||Mean Difference (Net)|1.0||||0.11|2-Sided||||||t-test, 2 sided||||
1627445|NCT02182830|2988593|Superiority|A hierarchical multiple testing procedure was used to evaluate superiority of the primary endpoint|Adjusted mean difference|-0.78|Standard Error of the Mean|0.2||0.0002|2-Sided|95.0|-1.18|-0.38|||Mixed Models Analysis||Empagliflozin minus Placebo|MMRM model : “HbA1c baseline,” “treatment,” “renal function,” “pre-treatment with metformin,” “visit,” “visit by treatment interaction,” and “HbA1c baseline by treatment interaction.” “Treatment,” “renal function,” “pre-treatment with metformin,” “visit,” and “visit by treatment interaction” were fixed classification effects, and “HbA1c baseline” was a linear covariate. The interaction “visit by HbA1c baseline interaction” was based on the linear covariate “HbA1c baseline.”|
1627446|NCT02182440|2988597|Superiority||Hazard Ratio (HR)|1.85||||0.03|2-Sided|95.0|1.06|3.26|||Regression, Logistic||||
1627447|NCT02182440|2988598|Superiority||Hazard Ratio (HR)|1.77||||0.045|2-Sided|95.0|1.0|3.1|||Regression, Logistic||||
1627448|NCT02182440|2988599|Superiority||Mean Difference (Net)|0.12||||0.03|2-Sided|95.0|0.01|0.23|||Cochran-Mantel-Haenszel||||
1627449|NCT02182440|2988600|Superiority||Mean Difference (Net)|0.12||||0.02|2-Sided|95.0|0.02|0.23|||Cochran-Mantel-Haenszel||||
1627450|NCT02182440|2988601|Superiority||Odds Ratio (OR)|1.4||||0.28|2-Sided|95.0|0.8|2.4|||Chi-squared||||
1627451|NCT02182440|2988602|Superiority||Combined p-value|0.896||||0.896|2-Sided||||||Inverse normal method||The p-values from Part 1 (see Statistical Analysis 1) and Part 2 (see Statistical Analysis 2) were combined to an overall p-value using the inverse normal method.|Combination of analysis results from Part 1 (see statistical Analysis 1) and Part 2 (see Statistical analysis 2)|
1627452|NCT02182440|2988602|Superiority||Difference in LS means|-4.65|Standard Error of the Mean|9.305||0.691|2-Sided|95.0|-23.09|13.8|||ANOVA|||Analysis for Part 2|
1627453|NCT02182440|2988602|Superiority||Difference in LS means|-16.53|Standard Error of the Mean|19.243||0.949|2-Sided|95.0|-62.57|29.5|||ANOVA|||Analysis for Part 1|
1627454|NCT02181673|2988659|Superiority or Other||Percent Difference|53.4|||<|0.001|2-Sided|95.0|45.8|60.9|||Cochran-Mantel-Haenszel||||
1627455|NCT02181634|2988666|Superiority||Hazard Ratio (HR)|1.54||||0.34|2-Sided|95.0|0.64|3.71|||Log Rank||||
1627456|NCT02181634|2988667|Superiority||Hazard Ratio (HR)|2.02||||0.099|2-Sided|95.0|0.86|4.75|||Log Rank||||
1627457|NCT02181413|2988711|Superiority||Hazard Ratio (HR)|0.72||||0.002|2-Sided|95.0|0.582|0.89|||Log Rank|P-value was based on log-rank test stratified by pre-induction regimen, International Staging System (ISS) stage and response after transplantation.|HR was based on Cox's proportional hazard regression model stratified by pre-induction regimen, pre-induction ISS stage and response after transplantation. <1 HR indicates better prevention of progression in Ixazomib arm compared to Placebo.||
1627458|NCT02181400|2988712|Other|||||||0.49|||||||ANCOVA||||
1627459|NCT02181400|2988713|Other|||||||0.02|||||||ANCOVA||||
1627460|NCT02181400|2988714|Other|||||||0.32|||||||ANCOVA||||
1627461|NCT02181400|2988715|Other|||||||0.12|||||||ANCOVA||||
1627462|NCT02181400|2988716|Other|||||||0.04|||||||ANCOVA||||
1627463|NCT02181400|2988717|Other|||||||0.04|||||||ANCOVA||||
1627464|NCT02181387|2988718|Other|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups||||
1627465|NCT02181387|2988718|Other|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups||||
1627466|NCT02181075|2988764|Superiority|||||||0.024||||||Not adjusted for multiple comparisons. A priori threshold < 0.05|t-test, 2 sided|95% confidence interval (CI)||A paired t-test was used for Part I (Arm 1) only. Analysis only applies to Part I (Arm 1) because only this study arm has matched Post-LTLD (i.e. post-drug alone) and Post-LTLD+FUS biopsy samples obtained from the same liver tumours before and after targeted drug delivery. In Part II of the study design in which drug delivery occurred completely non-invasively, no Post-LTLD tissue sample is obtained and only a single tumour biopsy is obtained following drug delivery (Post-LTLD+FUS).|
1627467|NCT02180828|2988769|Superiority or Other|||||||0.274|||||||Chi-squared||||
1627468|NCT02180828|2988770|Superiority or Other|||||||0.123|||||||Chi-squared||||
1627469|NCT02180828|2988771|Superiority or Other|||||||0.658|||||||Chi-squared||||
1627470|NCT02180828|2988772|Superiority or Other|||||||0.002|||||||Chi-squared||||
1627471|NCT02180828|2988773|Superiority or Other|||||||0.01|||||||Chi-squared||||
1627472|NCT02180828|2988774|Non-Inferiority or Equivalence|Yes||||||0.147|||||||Chi-squared||||
1627473|NCT02180828|2988775|Non-Inferiority or Equivalence|90% power and a two-sided alpha level of 0.05||||||0.147|||||||Chi-squared||||
1627474|NCT02180828|2988776|Non-Inferiority or Equivalence|Yes||||||0.298|||||||Chi-squared||||
1627475|NCT02180828|2988777|Non-Inferiority or Equivalence|Yes||||||0.925|||||||Chi-squared||||
1627476|NCT02180659|2988782|Superiority||Median Difference (Final Values)|-1.3||||0.505|2-Sided||||||ANOVA|||Comparing change in baseline to week 24 between the two groups.|
1627477|NCT02180659|2988783|Superiority||Mean Difference (Final Values)|-0.6||||0.425|2-Sided||||||ANOVA||||
1627478|NCT02180659|2988784|Superiority||Mean Difference (Final Values)|0.0||||0.922|2-Sided||||||ANOVA||||
1627479|NCT02180659|2988785|Superiority||Mean Difference (Final Values)|-0.4||||0.832|2-Sided||||||ANOVA|||Comparing change in baseline to week 24 between the two groups.|
1627480|NCT02180659|2988787|Superiority|||||||0.037|||||||Log Rank||||
1627481|NCT02180659|2988788|Superiority|At month 6 comparing those subject with no illicit drug use.||||||0.306|||||||Chi-squared||||
1627482|NCT02180659|2988789|Non-Inferiority|"For the primary efficacy variable, a test of non-inferiority of Probuphine (active) versus SL BPN (control) responders was conducted. A non-inferiority margin of 20% was employed to define noninferiority.~A Confidence Interval (CI) for the difference in proportions was calculated, and non-inferiority was established if the lower bound of the 95% CI for the difference of proportions (Probuphine – SL BPN) was greater than –0.20."|Difference in Response Rate|0.088|||<|0.001|2-Sided|95.0|0.009|0.167|||Chi-squared||||
1627483|NCT02180061|2988830|Superiority|||||||0.0216||||||One-sided p-value. The ORR was deemed clinically meaningful if the lower bound of the 95% confidence interval exceeded 10% (p<0.0250).|Exact Binomial Distribution||||
1627489|NCT02179047|2988886|Superiority||Hazard Ratio (HR)|1.05|Standard Deviation|0.005||0.002|2-Sided|95.0|||||ANOVA||||
1627490|NCT02179047|2988887|Superiority||Hazard Ratio (HR)|1.02||||0.002|2-Sided||||||ANOVA||||
1627491|NCT02178995|2988888|Superiority or Other|||||||0.2|||||||ANOVA|||HRT epilepsy vs healthy ANOVA|
1627492|NCT02178995|2988888|Superiority or Other|||||||0.075|||||||t-test, 2 sided|||HRT v1 vs v5 healthy|
1627493|NCT02178995|2988888|Superiority or Other|||||||0.5|||||||t-test, 2 sided|||HRT v1 vs v5 epilepsy|
1627494|NCT02178995|2988889|Superiority or Other|||||||0.793|||||||t-test, 2 sided|||HRT 10mg vs 20mg|
1627495|NCT02178995|2988889|Superiority or Other|||||||0.48|||||||ANOVA|||HRT ANOVA|
1627496|NCT02178995|2988890|Superiority or Other|||||||0.745|||||||t-test, 2 sided|||10mg vs 20mg perseverations|
1627497|NCT02178995|2988890|Superiority or Other|||||||0.362|||||||t-test, 2 sided|||10mg vs 20mg variability|
1627498|NCT02178995|2988890|Superiority or Other|||||||0.745|||||||ANOVA|||Perseverations ANOVA|
1627499|NCT02178995|2988890|Superiority or Other|||||||0.397|||||||ANOVA|||Variability ANOVA|
1627500|NCT02178995|2988891|Superiority or Other|||||||0.661|||||||ANOVA|||Perseverations 2-way ANOVA healthy vs epilepsy|
1627501|NCT02178995|2988891|Superiority or Other|||||||0.104|||||||t-test, 2 sided|||Perseverations v1 vs v5 healthy|
1627502|NCT02178995|2988891|Superiority or Other|||||||0.17|||||||t-test, 2 sided|||Perseverations v1 vs v5 epilepsy|
1627503|NCT02178995|2988891|Superiority or Other|||||||0.136|||||||ANOVA|||Variability 2-way ANOVA healthy vs epilepsy|
1627504|NCT02178995|2988891|Superiority or Other|||||||0.096|||||||t-test, 2 sided|||Variability v1 vs v5 healthy|
1627505|NCT02178995|2988891|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Variability v1 vs v5 epilepsy|
1627506|NCT02178995|2988892|Superiority or Other|||||||0.103|||||||t-test, 2 sided|||Social Isolation|
1627507|NCT02178995|2988892|Superiority or Other|||||||0.626|||||||t-test, 2 sided|||Social Support|
1627508|NCT02178995|2988892|Superiority or Other|||||||0.609|||||||t-test, 2 sided|||Medication Effects|
1627509|NCT02178995|2988892|Superiority or Other|||||||0.063|||||||t-test, 2 sided|||Seizure Worry|
1627510|NCT02178995|2988892|Superiority or Other|||||||0.007|||||||t-test, 2 sided|||Health Discouragement|
1627511|NCT02178995|2988892|Superiority or Other|||||||0.077|||||||t-test, 2 sided|||Emotional Wellbeing|
1627512|NCT02178995|2988892|Superiority or Other|||||||0.026|||||||t-test, 2 sided|||Work/Driving/Social|
1627513|NCT02178995|2988892|Superiority or Other|||||||0.128|||||||t-test, 2 sided|||Pain|
1627514|NCT02178995|2988892|Superiority or Other|||||||0.014|||||||t-test, 2 sided|||Role Limitations (Physical)|
1627515|NCT02178995|2988892|Superiority or Other|||||||0.065|||||||t-test, 2 sided|||Role Limitations (Emotional)|
1627516|NCT02178995|2988892|Superiority or Other|||||||0.164|||||||t-test, 2 sided|||Physical Function|
1627517|NCT02178995|2988892|Superiority or Other|||||||0.01|||||||t-test, 2 sided|||Overall QOL (subjectively rated by participants on the scale)|
1627518|NCT02178995|2988892|Superiority or Other|||||||0.011|||||||t-test, 2 sided|||Health Perceptions|
1627519|NCT02178995|2988893|Superiority or Other|||||||0.222|||||||ANOVA|||Between-groups comparison 2-way ANOVA AES|
1627520|NCT02178995|2988893|Superiority or Other|||||||0.646|||||||t-test, 2 sided|||AES visit 1 vs visit 5 healthy controls|
1627521|NCT02178995|2988893|Superiority or Other|||||||0.045|||||||t-test, 2 sided|||AES visit 1 vs visit 5 epilepsy|
1627522|NCT02178995|2988893|Superiority or Other|||||||0.792|||||||ANOVA|||Between-groups comparison 2-way ANOVA BAI|
1627523|NCT02178995|2988893|Superiority or Other|||||||0.477|||||||t-test, 2 sided|||BAI visit 1 vs visit 5 healthy controls|
1627524|NCT02178995|2988893|Superiority or Other|||||||0.42|||||||t-test, 2 sided|||BAI visit 1 vs visit 5 epilepsy|
1627525|NCT02178995|2988893|Superiority or Other|||||||0.191|||||||t-test, 2 sided|||Between-group comparison 2-way ANOVA BDI|
1627526|NCT02178995|2988893|Superiority or Other|||||||0.04|||||||t-test, 2 sided|||Healthy controls BDI v1 vs v5|
1627527|NCT02178995|2988893|Superiority or Other|||||||0.014|||||||t-test, 2 sided|||BDI epilepsy v1 vs v5|
1627528|NCT02178995|2988894|Superiority or Other|||||||0.003||||||Note: Stimulant side-effect score *decreased* with addition of open-label stimulant.|t-test, 2 sided||||
1627529|NCT02178995|2988895|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1627530|NCT02178995|2988896|Superiority or Other|||||||0.019|||||||ANOVA|||Healthy vs epilepsy ANOVA (2-way) commissions|
1627531|NCT02178995|2988896|Superiority or Other|||||||0.42|||||||t-test, 2 sided|||Commissions v1 vs v5 healthy|
1627532|NCT02178995|2988896|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Commissions v1 vs v5 epilepsy|
1627533|NCT02178995|2988896|Superiority or Other||||||<|0.048|||||||t-test, 2 sided|||Epilepsy v healthy ANOVA Omissions|
1627534|NCT02178995|2988896|Superiority or Other||||||<|0.029|||||||t-test, 2 sided|||Omissions v1 vs v5 healthy|
1627535|NCT02178995|2988896|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Omissions epilepsy v1 vs v5|
1627536|NCT02178995|2988896|Superiority or Other||||||<|0.079|||||||ANOVA|||2-way ANOVA epilepsy vs healthy hits|
1627537|NCT02178995|2988896|Superiority or Other||||||<|0.033|||||||t-test, 2 sided|||Hits v1 vs v5 healthy|
1627538|NCT02178995|2988896|Superiority or Other||||||<|0.003|||||||t-test, 2 sided|||Hits v1 vs v5 epilepsy|
1627539|NCT02178995|2988897|Superiority or Other|||||||0.001|||||||t-test, 2 sided|||Energy/fatigue subscale|
1627540|NCT02178995|2988897|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||Language subscale|
1627541|NCT02178995|2988897|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Memory subscale|
1627542|NCT02178995|2988897|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Attention/Concentration subscale|
1627543|NCT02178995|2988898|Superiority or Other|||||||0.7116|||||||t-test, 2 sided|||Comparison of baseline rate of seizures (expressed as seizures per 28 days) pre-trial against the rate experienced during the double-blind portion of our trial.|
1627544|NCT02178995|2988899|Superiority or Other|||||||0.898|||||||t-test, 2 sided|||Commissions 10mg vs 20mg|
1627545|NCT02178995|2988899|Superiority or Other|||||||0.932|||||||t-test, 2 sided|||Omissions 10mg vs 20mg|
1627546|NCT02178995|2988899|Superiority or Other|||||||0.876|||||||t-test, 2 sided|||Hits 10mg vs 20mg|
1627547|NCT02178995|2988899|Superiority or Other|||||||0.329||||||Commissions p = 0.329|ANOVA||||
1627548|NCT02178995|2988899|Superiority or Other|||||||0.038||||||Omissions p = 0.038|ANOVA||||
1627549|NCT02178995|2988899|Superiority or Other|||||||0.04||||||Hits p = 0.04|ANOVA||||
1627550|NCT02178995|2988900|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1627551|NCT02178995|2988901|Superiority or Other|||||||0.274|||||||t-test, 2 sided||||
1627552|NCT02178995|2988902|Superiority or Other|||||||0.906|||||||ANOVA|||Between-groups analysis by 2-way ANOVA|
1627553|NCT02178995|2988902|Superiority or Other|||||||0.004|||||||t-test, 2 sided||||
1627554|NCT02178995|2988902|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1627555|NCT02178995|2988903|Superiority or Other|||||||0.443|||||||ANOVA|||Group x time interaction by 2-way ANOVA|
1627556|NCT02178995|2988903|Superiority or Other|||||||0.022|||||||t-test, 2 sided||||
1627557|NCT02178995|2988903|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1627558|NCT02178995|2988904|Superiority or Other|||||||0.08|||||||ANOVA|||Intra-group analysis by 2-way ANOVA, d'|
1627559|NCT02178995|2988904|Superiority or Other|||||||0.037|||||||t-test, 2 sided|||Intra-group analysis, healthy controls, d'|
1627560|NCT02178995|2988904|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Intra-group comparison, epilepsy, D'|
1627561|NCT02178995|2988904|Superiority or Other||||||<|0.322|||||||ANOVA|||Between-group comparisons by 2-way ANOVA, HRTSD|
1627562|NCT02178995|2988904|Superiority or Other||||||<|0.001||||||HRTSD p <0.001 for healthy controls|t-test, 2 sided|||Intra-group comparison, HRTSD, healthy controls|
1627563|NCT02178995|2988904|Superiority or Other||||||<|0.0001||||||HRTSD P<0.0001|t-test, 2 sided|||Intra-group comparison, HRTSD|
1627564|NCT02178995|2988905|Superiority or Other|||||||0.779|||||||t-test, 2 sided|||MCG 10mg vs 20mg|
1627565|NCT02178995|2988905|Superiority or Other|||||||0.154|||||||ANOVA||||
1627566|NCT02178995|2988906|Superiority or Other|||||||0.071|||||||t-test, 2 sided|||SDMT 10mg vs 20mg|
1627567|NCT02178995|2988906|Superiority or Other|||||||0.008|||||||ANOVA||||
1627568|NCT02178995|2988907|Superiority or Other|||||||0.499|||||||t-test, 2 sided|||d' 10mg vs 20mg|
1627569|NCT02178995|2988907|Superiority or Other|||||||0.758|||||||t-test, 2 sided|||HRTSD 10mg vs 20mg|
1627570|NCT02178995|2988907|Superiority or Other|||||||0.055||||||D' p = 0.055. p < 0.05 considered significant.|ANOVA|Within-subjects contrasts, placebo v 10mg v 20mg.|||
1627571|NCT02178995|2988907|Superiority or Other|||||||0.037||||||HRTSD p-value = 0.037; p < 0.05 considered significant|ANOVA|Within-subjects contrasts, n=31, df=1|||
1627572|NCT02178696|2988945|Other||Mean Difference (Net)|0.12|Standard Deviation|0.31|<|0.001|2-Sided|95.0|0.016|0.23||A p<0.001 was established for regions a priori hypothesized (e.g. nucleus accumbens).|t-test, 2 sided||||
1627573|NCT02178553|2988958|Non-Inferiority|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.375|2-Sided|90.0|-0.3|1.0|||t-test, 2 sided||||
1627574|NCT02178553|2988959|Non-Inferiority|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.014|2-Sided|90.0|0.4|1.9|||t-test, 2 sided||||
1627575|NCT02178553|2988960|Non-Inferiority|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.101|2-Sided|90.0|0.4|1.9|||t-test, 2 sided||||
1627576|NCT02178553|2988961|Non-Inferiority|We determined that a difference of 1 unit between groups would be the bound for non-inferiorty.|Confidence Interval|1.0||||0.142|2-Sided|90.0|-0.1|1.8|||t-test, 2 sided||||
1627577|NCT02178059|2988984|Non-Inferiority or Equivalence|Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are <1.25 provided that the true mean ratios are <1.05.|Ratio of geometric means (%)|91.44|||||2-Sided|90.0|84.82|98.58|||||Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)|No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25|
1627578|NCT02178059|2988988|Superiority or Other||Median Difference (Final Values)|0.0||||0.8052|2-Sided|90.0|-0.17|0.17|||Wilcoxon signed rank test||||
1627579|NCT02178059|2988989|Non-Inferiority or Equivalence|Approximately 34 healthy volunteers will be entered into the study in order to complete 30 evaluable volunteers. Based on the study SD-001-0268, a residual intra-individual standard deviation of 0.300/sqrt(2) = 0.212 can be expected on the natural log scale. With 30 completed volunteers there will be a 93% chance that the upper limits of two-sided 90% CI for Cmax and AUC ratios are <1.25 provided that the true mean ratios are <1.05.|Ratio of geometric means (%)|88.2|||||2-Sided|90.0|81.03|96.02|||||Comparison of Bricanyl Turbuhaler M3 (test) to Bricanyl Turbuhaler M2 (reference)|No increase in the exposure of plasma terbutaline after administration of Bricanyl Turbuhaler M3 will be concluded if the upper bound of the 90% CIs for the ratios of AUC and Cmax are both below 1.25|
1627580|NCT02177942|2988998|Superiority or Other||Mean Difference (Net)|-0.03||||0.6931|2-Sided|95.0|-0.2|0.13|||ANCOVA||Difference is test treatment minus control treatment such that a positive difference favours the test treatment.||
1627581|NCT02177786|2989041|Superiority||Difference in Percentages|-2.9||||0.686|2-Sided|95.0|-16.6|10.9|||Cochran-Mantel-Haenszel|P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.||
1627764|NCT02173054|2989599|Superiority or Other|||||||0.016||||||This statistical analysis was used to compare number of participants who had dryness among 3 groups|Kruskal-Wallis||||
1628896|NCT02145156|2992164|Superiority or Other|||||||0.35|||||||Fisher Exact||||
1627582|NCT02177786|2989041|Superiority||Difference in Percentages|-9.2||||0.175|2-Sided|95.0|-22.3|4.0|||Cochran-Mantel-Haenszel|P-value was based on a CMH test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% CI in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.||
1627583|NCT02177786|2989041|Superiority||Difference in Percentages|-2.2||||0.798|2-Sided|95.0|-16.1|11.7|||Cochran-Mantel-Haenszel|P-value was based on a Cochran-Mantel-Haenszel (CMH) test stratified by stage of disease to compare the response rate between selonsertib and placebo.|The 95% confidence interval (CI) in the difference in percentages between selonsertib and placebo was based on Wald Asymptotic test.||
1627584|NCT02177786|2989042|Superiority||Least Square Means Difference|-0.87|Standard Error of the Mean|1.23||0.481|2-Sided|95.0|-3.29|1.56||Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM||||
1627585|NCT02177786|2989042|Superiority||Least Square Means Difference|0.84|Standard Error of the Mean|1.22||0.492|2-Sided|95.0|-1.55|3.23||Data was calculated using a MMRM model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM||||
1627586|NCT02177786|2989042|Superiority||Least Square Means Difference|0.38|Standard Error of the Mean|1.21||0.755|2-Sided|95.0|-2.0|2.75||Data was calculated using a mixed-effect model repeated measures (MMRM) model including terms for treatment group, baseline eGFR, visit and treatment by visit interaction for comparison of change from baseline in eGFR between selonsertib and placebo.|MMRM||||
1627587|NCT02177201|2989050|Superiority or Other||||||<|0.05|||||||Chi-squared, Corrected|||77 patients was needed in each groups for an 20% effect size, 5% alpha and 80% statistical power for postoperative vomiting.|
1627588|NCT02177201|2989050|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Null hypothesis: The antiemetic effect was not significantly different for two groups in this study|
1627589|NCT02177136|2989058|Superiority|||||||0.0665|||||||ANCOVA|ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.|||
1627590|NCT02177136|2989058|Superiority|||||||0.0434|||||||ANCOVA|ANCOVA model with treatment group and randomization stratification factors as fixed effects and baseline as covariate.|||
1627591|NCT02177032|2989066|Non-Inferiority or Equivalence|The non-inferiority in immune response of the “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is > -0.05 (non-inferiority margin).|Protection Rate Differences|-25.0|||||2-Sided|95.0|-37.8|-13.2|||||||
1627592|NCT02177032|2989066|Non-Inferiority or Equivalence|The non-inferiority in immune response of the “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is > -0.05 (non-inferiority margin).|Protection Rate Differences|-17.0|||||2-Sided|95.0|-29.0|-7.1|||||||
1627593|NCT02177032|2989066|Non-Inferiority or Equivalence|The non-inferiority in immune response of the “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is > -0.05 (non-inferiority margin).|Protection Rate Differences|-15.0|||||2-Sided|95.0|-26.0|-7.1|||||||
1627594|NCT02177032|2989066|Non-Inferiority or Equivalence|The non-inferiority in immune response of the “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is > -0.05 (non-inferiority margin).|Protection Rate Differences|0.0|||||2-Sided|95.0|-5.6|2.6|||||||
1627595|NCT02177032|2989066|Non-Inferiority or Equivalence|The non-inferiority in immune response of the “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, with HRIG administration, compared to that of the new “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen of the PCEC vaccine, without HRIG administration, in adult subjects will be established if the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is > -0.05 (non-inferiority margin).|Protection Rate Differences|-11.0|||||2-Sided|95.0|-19.6|-1.0|||||||
1627596|NCT02177032|2989067|Non-Inferiority or Equivalence|The non-inferiority in immune response of the “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen compared to the currently recommended “2-sites TRC” (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 366 is > -0.05 (non-inferiority margin).|Protection Rate Differences|6.0|||||2-Sided|95.0|1.3|11.5|||||||
1627597|NCT02177032|2989067|Non-Inferiority or Equivalence|The non-inferiority in immune response of the “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen compared to the currently recommended “2-sites TRC” (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 181 is > -0.05 (non-inferiority margin).|Protection Rate Differences|-1.0|||||2-Sided|95.0|-4.5|3.2|||||||
1627598|NCT02177032|2989067|Non-Inferiority or Equivalence|The non-inferiority in immune response of the “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen compared to the currently recommended “2-sites TRC” (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 91 is > -0.05 (non-inferiority margin).|Protection Rate Differences|-3.0|||||2-Sided|95.0|-6.0|-1.4|||||||
1627599|NCT02177032|2989067|Non-Inferiority or Equivalence|The non-inferiority in immune response of the “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen compared to the currently recommended “2-sites TRC” (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 15 is > -0.05 (non-inferiority margin).|Protection Rate Differences|0.0|||||2-Sided|95.0|-1.0|1.6|||||||
1627600|NCT02177032|2989067|Non-Inferiority or Equivalence|The non-inferiority in immune response of the “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen compared to the currently recommended “2-sites TRC” (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at Day 8 is > -0.05 (non-inferiority margin).|Protection Rate Differences|9.0|||||2-Sided|95.0|3.8|13.9|||||||
1627601|NCT02177032|2989068|Non-Inferiority or Equivalence|The investigational regimen 4-sites, 1-week” ID PEP will be declared as non-inferior to currently recommended “2-sites TRC” ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 366)|Vaccine Group Ratios|1.67|||||2-Sided|95.0|1.27|2.19|||||||
1627602|NCT02177032|2989068|Non-Inferiority or Equivalence|The investigational regimen 4-sites, 1-week” ID PEP will be declared as non-inferior to currently recommended “2-sites TRC” ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 181)|Vaccine Group Ratios|1.22|||||2-Sided|95.0|0.94|1.59|||||||
1627603|NCT02177032|2989068|Non-Inferiority or Equivalence|The investigational regimen 4-sites, 1-week” ID PEP will be declared as non-inferior to currently recommended “2-sites TRC” ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 91).|Vaccine Group Ratios|0.68|||||2-Sided|95.0|0.54|0.85|||||||
1627604|NCT02177032|2989068|Non-Inferiority or Equivalence|The investigational regimen 4-sites, 1-week” ID PEP will be declared as non-inferior to currently recommended “2-sites TRC” ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 15)|Vaccine Group Ratios|1.68|||||2-Sided|95.0|1.35|2.1|||||||
1627605|NCT02177032|2989068|Non-Inferiority or Equivalence|The investigational regimen 4-sites, 1-week” ID PEP will be declared as non-inferior to currently recommended “2-sites TRC” ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667 (Day 8)|Vaccine Group Ratios|1.04|||||2-Sided|95.0|0.84|1.29|||||||
1627606|NCT02177032|2989069|Non-Inferiority or Equivalence|The investigational regimen 4-sites, 1-week” ID PEP will be declared as non-inferior to currently recommended “2-sites TRC” ID PEP regimen if the lower bound of the two sided 95% confidence interval around of the observed GMC ratio is greater than 0.667.|Vaccine Group Ratios|0.46|||||2-Sided|95.0|0.37|0.58|||||||
1627607|NCT02177032|2989070|Non-Inferiority or Equivalence|The non-inferiority in immune response of the “4-sites, 1-week” (4-4-4-0-0) ID PEP regimen compared to the currently recommended “2-sites TRC” (2-2-2-0-2) ID PEP regimen, with or without HRIG, will be established If the lower bound of the two sided 95% confidence interval around the differences of the percentage of subject with RVNA titer ≥ 0.5 IU/ml at day 50 is > -0.05 (non-inferiority margin).|Protection Rate Differences|-1.0|||||2-Sided|95.0|-2.4|0.0|||||||
1627608|NCT02176642|2989083|Superiority|||||||0.94|||||||Wilcoxon (Mann-Whitney)||||
1627609|NCT02176642|2989084|Superiority|||||||0.73|||||||Wilcoxon (Mann-Whitney)||||
1627610|NCT02176642|2989085|Superiority|||||||0.44|||||||Wilcoxon (Mann-Whitney)||||
1627611|NCT02176642|2989086|Superiority|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1627612|NCT02176642|2989087|Superiority|||||||0.06|||||||Wilcoxon (Mann-Whitney)||||
1627613|NCT02176642|2989088|Superiority|||||||0.26|||||||Wilcoxon (Mann-Whitney)||||
1627614|NCT02176642|2989089|Superiority|||||||0.48|||||||Wilcoxon (Mann-Whitney)||||
1627615|NCT02176642|2989090|Superiority|||||||0.4|||||||Wilcoxon (Mann-Whitney)||||
1627616|NCT02176642|2989091|Non-Inferiority|We estimated that women in the placebo group would have mean reduction of 3 UUI episodes per day. Assuming 50% improvement in UUI episodes per day is a clinically significant improvement, we estimated the experimental group would have a mean reduction of 4.5 UUI episodes per day with a SD of 1.5 UUI episodes per day. To detect such a difference with 80% power and alpha 0.05, we would need 88 participants for our analysis. To allow for a 12% dropout rate, our goal was to enroll 100 women.||||||0.2|||||||Wilcoxon (Mann-Whitney)||||
1627617|NCT02176226|2989164|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1627618|NCT02176226|2989165|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1627619|NCT02176005|2989185|Other||Contrast (B/A)|0.9391||||0.519|2-Sided|95.0|0.7969|1.1066|||General linear model||||
1627620|NCT02176005|2989186|Other||Contrast (B/A)|1.1763||||0.104|2-Sided|95.0|0.9982|1.3861|||General linear model||||
1627621|NCT02176005|2989187|Other||Contrast (B/A)|0.8785||||0.139|2-Sided|95.0|0.76|1.0155|||General linear model||||
1627622|NCT02176005|2989188|Other||Contrast (B/A)|0.9811||||0.806|2-Sided|95.0|0.8608|1.1182|||General linear model||||
1627623|NCT02176005|2989189|Other||Contrast (B/A)|0.0096|||<|1e-06|2-Sided|95.0|0.0061|0.0151|||General linear model||||
1627624|NCT02176005|2989190|Other||Contrast (B/A)|0.0093|||<|1e-06|2-Sided|95.0|0.006|0.0144|||General linear model||||
1627625|NCT02175771|2989208|Non-Inferiority|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than –125 mL.|LSM difference|0.059|Standard Error of the Mean|0.0464||0.2056|2-Sided|95.0|-0.032|0.15|||mixed model for repeated measures||FS MDPI / ADVAIR DISKUS|High-strength comparison|
1627626|NCT02175771|2989208|Non-Inferiority|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than –125 mL.|LSM difference|0.0|Standard Error of the Mean|0.0485||0.9966|2-Sided|95.0|-0.095|0.095|||mixed model for repeated measures||FS MDPI / ADVAIR DISKUS|Mid-strength comparison|
1627627|NCT02175771|2989208|Non-Inferiority|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than –125 mL.|LSM difference|-0.013|Standard Error of the Mean|0.0479||0.7877|2-Sided|95.0|-0.107|0.081|||mixed model for repeated measures||Fp MDPI / FLOVENT HFA|High-strength comparison|
1627628|NCT02175771|2989208|Non-Inferiority|The study had reasonable power for demonstrating non-inferiority of the study drug to the comparator drug within each cohort. The statistical analysis plan specified that non-inferiority would be demonstrated if the lower limit of the 2-sided 95% confidence interval (CI) for the treatment difference was greater than –125 mL.|LSM difference|0.009|Standard Error of the Mean|0.0476||0.8451|2-Sided|95.0|-0.084|0.103|||mixed model for repeated measures||Fp MDPI / FLOVENT HFA|Mid-strength comparison|
1627629|NCT02175771|2989209|Superiority||geometric mean ratio|0.84|||||2-Sided|90.0|0.67|1.06|||||FS MDPI / ADVAIR DISKUS|High-strength comparison|
1627630|NCT02175771|2989209|Superiority||geometric mean ratio|0.96|||||2-Sided|90.0|0.75|1.24|||||FS MDPI / ADVAIR DISKUS|Mid-strength comparison|
1627631|NCT02175771|2989209|Superiority||geometric mean ratio|0.81|||||2-Sided|90.0|0.63|1.04|||||Fp MDPI / FLOVENT HFA|High-strength comparison|
1627632|NCT02175771|2989209|Superiority||geometric mean ratio|1.32|||||2-Sided|90.0|1.02|1.72|||||Fp MDPI / FLOVENT HFA|Mid-strength comparison|
1627633|NCT02175758|2989230|Superiority||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate for the 3 to < 12 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.|
1627634|NCT02175758|2989230|Superiority||||||<|0.001|||||||2-sided exact 1-sample binomial test|||The SVR12 rate for the 12 to < 18 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level. If superiority was demonstrated in the 12 to < 18 Years Old group, then the SVR12 rate for participants aged 3 to < 12 years would be compared with 80% at the 0.05 significance level.|
1627635|NCT02175758|2989232|Equivalence|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|149.67|||||2-Sided|90.0|127.12|176.21||||||AUCtau of GS-331007 for the 3 to < 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.|
1627636|NCT02175758|2989232|Equivalence|Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|109.8|||||2-Sided|90.0|93.25|129.29||||||AUCtau of GS-331007 for the 6 to < 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.|
1627637|NCT02175758|2989232|Equivalence|Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.|Percentage Geometric Mean Ratio|129.48|||||2-Sided|90.0|109.96|152.48||||||AUCtau of GS-331007 for the 12 to < 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.|
1627638|NCT02175225|2989248|Other||Risk Ratio (RR)|1.84|||||2-Sided|95.0|0.63|5.35|||||||
1627639|NCT02175225|2989249|Other||Risk Ratio (RR)|0.89|||||2-Sided|95.0|0.51|1.54|||||Confidence interval constructed only for all cause owing to small number of events caused by acute respiratory distress syndrome.||
1627640|NCT02175225|2989250|Other||Risk Ratio (RR)|0.77|||||2-Sided|95.0|0.0|14.97|||||Confidence interval is exact (rather than asymptotic) due to small number of events.||
1627641|NCT02175225|2989253|Other||Odds Ratio, log|1.26|||||2-Sided|95.0|0.82|1.93|||||||
1627642|NCT02175225|2989254|Other||Odds Ratio (OR)|1.1|||||2-Sided|95.0|0.72|1.67|||||The estimation parameter is the adjusted common odds ratio.||
1627643|NCT02175225|2989255|Other|||||||0.83||||||The p value reflects the significance of the interaction term between treatment and onset to treatment time.|Regression, Logistic||||
1627644|NCT02175225|2989256|Other|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 13% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference [AARD]); if the upper bound on the risk difference was less than 13% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|-0.018|||||1-Sided|90.0||0.029|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference [AARD]); if UCB was less than 13% in favour of deferoxamine mesylate, this is considered evidence of futility.||
1627645|NCT02175225|2989257|Other|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 12% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference [AARD]); if the upper bound on the risk difference was less than 12% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.086|||||1-Sided|90.0||0.156|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference [AARD]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.||
1627646|NCT02175225|2989258|Other|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 13% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference [AARD]); if the upper bound on the risk difference was less than13% in favor of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.062|||||1-Sided|90.0||0.121|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference[AARD]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.||
1627647|NCT02175225|2989259|Other||Risk Ratio (RR)|0.94|||||2-Sided|95.0|0.57|1.56|||||||
1627648|NCT02175225|2989260|Other||Risk Ratio (RR)|0.81|||||2-Sided|95.0|0.57|1.16|||||||
1627765|NCT02173054|2989599|Superiority or Other|||||||0.001||||||This statistical analysis was used to compare number of participants who had erythema among 3 groups.|Kruskal-Wallis||||
1627649|NCT02175225|2989261|Other|The alternative hypothesis, reflecting futility, is that the absolute treatment effect is less than 12% in favor of deferoxamine. In accordance with the futility design, futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference [AARD]); if the upper bound on the risk difference was less than 12% in favour of deferoxamine mesylate, this would be considered evidence of futility.|Risk Difference (RD)|0.006|||||1-Sided|90.0||0.068|||||Futility was evaluated via the one-sided 90% upper confidence bound (90% UCB) of the treatment effect (absolute adjusted risk difference [AARD]); if UCB was less than 12% in favour of deferoxamine mesylate, this is considered evidence of futility.||
1627650|NCT02175212|2989264|Superiority or Other (legacy)||Hazard Ratio (HR)|2.48||||0.009|2-Sided|95.0|1.31|4.68|||Regression, Cox||||
1627651|NCT02175212|2989265|Superiority or Other (legacy)||Hazard Ratio (HR)|2.31||||0.01|2-Sided|95.0|1.23|3.85|||Regression, Cox||||
1627652|NCT02175212|2989266|Superiority or Other (legacy)||Hazard Ratio (HR)|1.88||||0.01|2-Sided|95.0|1.12|3.15|||Regression, Cox||||
1627653|NCT02175121|2989284|Superiority or Other||Mean Difference (Net)|9.23|Standard Error of the Mean|3.9||0.0192|2-Sided|90.0|2.77|15.69||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627654|NCT02175121|2989284|Superiority or Other||Mean Difference (Net)|-0.57|Standard Error of the Mean|3.84||0.8824|2-Sided|90.0|-6.93|5.79||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627655|NCT02175121|2989284|Superiority or Other||Mean Difference (Net)|0.57|Standard Error of the Mean|3.93||0.8857|2-Sided|90.0|-5.93|7.06||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627656|NCT02175121|2989284|Superiority or Other||Mean Difference (Net)|-0.84|Standard Error of the Mean|3.85||0.8277|2-Sided|90.0|-7.2|5.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627657|NCT02175121|2989284|Superiority or Other||Mean Difference (Net)|9.78|Standard Error of the Mean|4.14||0.0192|2-Sided|90.0|2.94|16.63||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627658|NCT02175121|2989284|Superiority or Other||Mean Difference (Net)|-1.49|Standard Error of the Mean|4.07||0.7142|2-Sided|90.0|-8.23|5.24||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627659|NCT02175121|2989284|Superiority or Other||Mean Difference (Net)|3.99|Standard Error of the Mean|4.16||0.3396|2-Sided|90.0|-2.9|10.87||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627660|NCT02175121|2989284|Superiority or Other||Mean Difference (Net)|0.13|Standard Error of the Mean|4.08||0.975|2-Sided|90.0|-6.62|6.87||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627661|NCT02175121|2989285|Superiority or Other||Mean Difference (Net)|14.92|Standard Error of the Mean|3.63|<|0.0001|2-Sided|90.0|8.92|20.92||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627662|NCT02175121|2989285|Superiority or Other||Mean Difference (Net)|4.56|Standard Error of the Mean|3.58|<|0.2041|2-Sided|90.0|-1.36|10.48||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627663|NCT02175121|2989285|Superiority or Other||Mean Difference (Net)|1.2|Standard Error of the Mean|3.66|<|0.743|2-Sided|90.0|-4.86|7.26||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627664|NCT02175121|2989285|Superiority or Other||Mean Difference (Net)|0.58|Standard Error of the Mean|3.58|<|0.8717|2-Sided|90.0|-5.35|6.51||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627665|NCT02175121|2989285|Superiority or Other||Mean Difference (Net)|12.89|Standard Error of the Mean|4.01|<|0.0016|2-Sided|90.0|6.26|19.53||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627666|NCT02175121|2989285|Superiority or Other||Mean Difference (Net)|7.64|Standard Error of the Mean|3.96|<|0.0553|2-Sided|90.0|1.09|14.18||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627930|NCT02164539|2990191|Superiority or Other||Mean Difference (Net)|19.7|||<|0.001|2-Sided|95.0|7.7|31.7|||ANCOVA||||
1627667|NCT02175121|2989285|Superiority or Other||Mean Difference (Net)|4.61|Standard Error of the Mean|4.05|<|0.2569|2-Sided|90.0|-2.09|11.3||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627668|NCT02175121|2989285|Superiority or Other||Mean Difference (Net)|1.77|Standard Error of the Mean|3.96|<|0.6553|2-Sided|90.0|-4.78|8.33||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627669|NCT02175121|2989286|Superiority or Other||Mean Difference (Net)|12.34|Standard Error of the Mean|4.28||0.0044|2-Sided|90.0|5.26|19.41||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627670|NCT02175121|2989286|Superiority or Other||Mean Difference (Net)|-0.11|Standard Error of the Mean|4.21||0.9791|2-Sided|90.0|-7.07|6.85||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627671|NCT02175121|2989286|Superiority or Other||Mean Difference (Net)|0.37|Standard Error of the Mean|4.3||0.9312|2-Sided|90.0|-6.74|7.49||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627672|NCT02175121|2989286|Superiority or Other||Mean Difference (Net)|-0.29|Standard Error of the Mean|4.21||0.9448|2-Sided|90.0|-7.25|6.67||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627673|NCT02175121|2989286|Superiority or Other||Mean Difference (Net)|9.07|Standard Error of the Mean|4.32||0.0373|2-Sided|90.0|1.93|16.21||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627674|NCT02175121|2989286|Superiority or Other||Mean Difference (Net)|-0.3|Standard Error of the Mean|4.25||0.9445|2-Sided|90.0|-7.33|6.73||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627675|NCT02175121|2989286|Superiority or Other||Mean Difference (Net)|1.66|Standard Error of the Mean|4.34||0.7028|2-Sided|90.0|-5.52|8.84||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627676|NCT02175121|2989286|Superiority or Other||Mean Difference (Net)|-2.12|Standard Error of the Mean|4.25||0.6182|2-Sided|90.0|-9.15|4.91||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627677|NCT02175121|2989287|Superiority or Other||Mean Difference (Net)|9.59|Standard Error of the Mean|3.01||0.0018|2-Sided|90.0|4.6|14.58||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627678|NCT02175121|2989287|Superiority or Other||Mean Difference (Net)|0.61|Standard Error of the Mean|2.97||0.837|2-Sided|90.0|-4.3|5.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627679|NCT02175121|2989287|Superiority or Other||Mean Difference (Net)|0.52|Standard Error of the Mean|3.03||0.8652|2-Sided|90.0|-4.5|5.53||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627680|NCT02175121|2989287|Superiority or Other||Mean Difference (Net)|-0.99|Standard Error of the Mean|2.96||0.7394|2-Sided|90.0|-5.89|3.92||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627681|NCT02175121|2989287|Superiority or Other||Mean Difference (Net)|9.74|Standard Error of the Mean|3.28||0.0034|2-Sided|90.0|4.32|15.16||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627682|NCT02175121|2989287|Superiority or Other||Mean Difference (Net)|1.19|Standard Error of the Mean|3.22||0.7132|2-Sided|90.0|-4.15|6.52||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627683|NCT02175121|2989287|Superiority or Other||Mean Difference (Net)|3.97|Standard Error of the Mean|3.29||0.2303|2-Sided|90.0|-1.48|9.42||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1628897|NCT02145156|2992165|Superiority or Other|||||||0.88|||||||Fisher Exact||||
1627684|NCT02175121|2989287|Superiority or Other||Mean Difference (Net)|0.6|Standard Error of the Mean|3.22||0.8516|2-Sided|90.0|-4.73|5.93||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627685|NCT02175121|2989288|Superiority or Other||Mean Difference (Net)|6.3|Standard Error of the Mean|7.73||0.4166|2-Sided|90.0|-6.49|19.08||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627686|NCT02175121|2989288|Superiority or Other||Mean Difference (Net)|1.42|Standard Error of the Mean|7.61||0.8523|2-Sided|90.0|-11.17|14.01||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627687|NCT02175121|2989288|Superiority or Other||Mean Difference (Net)|-0.4|Standard Error of the Mean|7.78||0.9588|2-Sided|90.0|-13.28|12.47||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627688|NCT02175121|2989288|Superiority or Other||Mean Difference (Net)|-2.2|Standard Error of the Mean|7.66||0.7741|2-Sided|90.0|-14.87|10.47||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627689|NCT02175121|2989288|Superiority or Other||Mean Difference (Net)|14.64|Standard Error of the Mean|10.25||0.1553|2-Sided|90.0|-2.32|31.59||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627690|NCT02175121|2989288|Superiority or Other||Mean Difference (Net)|5.6|Standard Error of the Mean|10.1||0.5802|2-Sided|90.0|-11.11|22.3||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627691|NCT02175121|2989288|Superiority or Other||Mean Difference (Net)|13.03|Standard Error of the Mean|10.33||0.2087|2-Sided|90.0|-4.05|30.11||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627692|NCT02175121|2989288|Superiority or Other||Mean Difference (Net)|12.86|Standard Error of the Mean|10.13||0.2063|2-Sided|90.0|-3.91|29.62||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day, statin use and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627693|NCT02175121|2989289|Superiority or Other||Mean Difference (Net)|-57.17|Standard Error of the Mean|5.41|<|0.0001|2-Sided|90.0|-66.12|-48.22||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627694|NCT02175121|2989289|Superiority or Other||Mean Difference (Net)|-51.47|Standard Error of the Mean|5.33|<|0.0001|2-Sided|90.0|-60.29|-42.65||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627695|NCT02175121|2989289|Superiority or Other||Mean Difference (Net)|-36.18|Standard Error of the Mean|5.46|<|0.0001|2-Sided|90.0|-45.21|-27.14||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627696|NCT02175121|2989289|Superiority or Other||Mean Difference (Net)|-27.07|Standard Error of the Mean|5.33|<|0.0001|2-Sided|90.0|-35.89|-18.25||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 28.|
1627697|NCT02175121|2989289|Superiority or Other||Mean Difference (Net)|-46.72|Standard Error of the Mean|5.89|<|0.0001|2-Sided|90.0|-56.46|-36.98||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627698|NCT02175121|2989289|Superiority or Other||Mean Difference (Net)|-39.6|Standard Error of the Mean|5.8|<|0.0001|2-Sided|90.0|-49.2|-30.0||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627699|NCT02175121|2989289|Superiority or Other||Mean Difference (Net)|-26.98|Standard Error of the Mean|5.94|<|0.0001|2-Sided|90.0|-36.81|-17.15||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627700|NCT02175121|2989289|Superiority or Other||Mean Difference (Net)|-16.25|Standard Error of the Mean|5.83|<|0.006|2-Sided|90.0|-25.9|-6.6||Two-sided p-values are from MMRM with baseline value, time, treatment group, study day and treatment interaction as fixed effects. Subject was used as a random effect.|Mixed Models Analysis|||Placebo was the Reference and each of the active doses was the Test for Day 14.|
1627931|NCT02164539|2990191|Superiority or Other||Mean Difference (Net)|21.8|||<|0.001|2-Sided|95.0|9.4|34.1|||ANCOVA||||
1627701|NCT02175121|2989290|Superiority or Other||Mean Difference (Net)|-68.12|Standard Error of the Mean|6.86|<|0.0001|2-Sided|90.0|-79.46|-56.78||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.|
1627702|NCT02175121|2989290|Superiority or Other||Mean Difference (Net)|-68.79|Standard Error of the Mean|6.73|<|0.0001|2-Sided|90.0|-79.92|-57.65||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.|
1627703|NCT02175121|2989290|Superiority or Other||Mean Difference (Net)|-45.53|Standard Error of the Mean|6.98|<|0.0001|2-Sided|90.0|-57.08|-33.99||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.|
1627704|NCT02175121|2989290|Superiority or Other||Mean Difference (Net)|-40.33|Standard Error of the Mean|6.75|<|0.0001|2-Sided|90.0|-51.49|-29.16||Two-sided p-values are from analysis of Covariance (ANCOVA) model with baseline value and treatment group as fixed effects.|ANCOVA|LS mean difference from placebo adjusted for baseline values is derived from the ANCOVA model.||Placebo was the Reference and each of the active doses was the Test.|
1627705|NCT02174848|2989305|Superiority|||||||0.5885|||||||t-test, 2 sided|||For the placebo-DFP group, the comparison is of the scores at the start vs. the end of the extension study; for the DFP-DFP group, the comparison is of the scores at the start vs. the end of the initial study|
1627706|NCT02174848|2989305|Superiority|||||||0.0821|||||||t-test, 2 sided|||This comparison is for the initial study, during which patients in the placebo-DFP group received placebo and patients in the DFP-DFP group received deferiprone|
1627707|NCT02174848|2989306|Superiority|||||||0.2684|||||||paired t-test||||
1627708|NCT02174848|2989307|Superiority|||||||0.9781|||||||paired t-test||||
1627709|NCT02174848|2989308|Superiority|||||||0.9781|||||||t-test, 2 sided|||This comparison is for the extension study, during which patients in both groups received deferiprone.|
1627710|NCT02174848|2989308|Superiority|||||||0.05|||||||t-test, 2 sided|||This comparison is for the initial study, during which patients in the placebo-DFP group received placebo and patients in the DFP-DFP group received deferiprone.|
1627711|NCT02174731|2989310|Non-Inferiority|Non-inferiority of roxadustat versus epoetin alfa was declared if the upper bound of the HR 95% CI of the difference between roxadustat and epoetin alfa was less than or equal to 1.8. Non-inferiority p-value is 1-sided. The CIs were from Wald and ties were calculated using the Efron method.|Hazard Ratio (HR)|0.83|||<|0.001|2-Sided|95.0|0.64|1.07|||Regression, Cox||||
1627712|NCT02174731|2989311|Superiority||||||<|0.0001|||||||Wilcoxon Rank Sum Test||||
1627713|NCT02174731|2989312|Non-Inferiority|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.2|Standard Error of the Mean|0.081|<|0.001|2-Sided|95.0|0.04|0.36|||ANCOVA|MAR-based multiple imputation.|Difference between groups (roxadustat minus Epoetin alfa) in LS mean.||
1627714|NCT02174731|2989313|Superiority|Superiority was also declared as the lower bound of the 95% CI exceeded 0 and p-value was lower than 0.05.|Least Square Mean Difference|-0.33|Standard Error of the Mean|0.03|<|0.001|2-Sided|95.0|-0.39|-0.27|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.||
1627715|NCT02174731|2989314|Non-Inferiority|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.15. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.02|Standard Error of the Mean|0.014|<|0.001|2-Sided|95.0|-0.01|0.05|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.||
1627716|NCT02174731|2989315|Non-Inferiority|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.15. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.03|Standard Error of the Mean|0.013|<|0.001|2-Sided|95.0|0.0|0.05|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean.||
1627717|NCT02174731|2989316|Non-Inferiority|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% CI of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.14|Standard Error of the Mean|0.056|<|0.001|2-Sided|95.0|0.03|0.25|||MMRM||Difference between groups (roxadustat minus Epoetin alfa) in LS mean change.||
1627718|NCT02174731|2989317|Non-Inferiority|Non-inferiority of roxadustat versus epoetin alfa was declared if the lower bound of the 95% confidence interval (CI) of the difference between roxadustat and epoetin alfa exceeded -0.75. Non-inferiority p-value is 1-sided.|Least Square Mean Difference|0.09|Standard Error of the Mean|0.044|<|0.001|2-Sided|95.0|0.01|0.18|||ANCOVA||Difference between groups (roxadustat minus Epoetin alfa) in LS mean changes.||
1627719|NCT02174627|2989318|Superiority|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.52|Standard Error of the Mean|0.269||0.051|2-Sided|95.0|0.0|1.05||Nominal p-value (as prior sequential outcome measure p-value did not meet < 0.05.|Mixed Models Analysis|||Difference between groups (roxadustat minus placebo) in LS mean changes; MMRM analysis.|
1627720|NCT02174627|2989319|Other||Rate of Change Difference|-0.51|Standard Error of the Mean|0.254||0.046|2-Sided|95.0|-1.0|-0.01||Nominal p-value (as prior sequential outcome measure p-value did not meet < 0.05.|Random Effects Analysis|||Difference between groups (roxadustat minus placebo) in rate of change in eGFR; random effects analysis.|
1627721|NCT02174627|2989320|Superiority|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.44|Standard Error of the Mean|0.283||0.12|2-Sided|95.0|-0.11|0.99|||Mixed Models Analysis|||Difference between groups (roxadustat minus placebo) in LS mean changes; MMRM analysis.|
1627766|NCT02172625|2989615|Superiority or Other||week-to-week coefficient of variation %|24.0|||||2-Sided||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.||
1627722|NCT02174627|2989321|Superiority|Superiority of roxadustat compared with placebo would be declared if the upper limit of the 2-sided 95% CI for the HR was ≤1.0.|Hazard Ratio (HR)|0.37|||<|0.001|2-Sided|95.0|0.3|0.44|||Regression, Cox|||Treatments were compared using a Cox proportional hazards model, with baseline Hb and baseline eGFR as continuous variables used as covariates, and treatment group, CV history and geographic region as fixed effects. The Efron method was used for ties and p-values were calculated using the Wald test.|
1627723|NCT02174627|2989322|Superiority|Superiority of roxadustat compared with placebo would be declared if the upper limit of the 2-sided 95% CI for the HR was ≤1.0.|Hazard Ratio (HR)|0.26|||<|0.001|2-Sided|95.0|0.23|0.31|||Regression, Cox|||Treatments were compared using a Cox proportional hazards model, with baseline Hb and baseline eGFR as continuous variables used as covariates, and treatment group, CV history and geographic region as fixed effects. The Efron method was used for ties and p-values were calculated using the Wald test.|
1627724|NCT02174627|2989323|Superiority|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|-0.36|Standard Error of the Mean|0.033|<|0.001|2-Sided|95.0|-0.42|-0.29|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.|
1627725|NCT02174627|2989324|Superiority|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.42|Standard Error of the Mean|0.013|<|0.001|2-Sided|95.0|0.4|0.45|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.|
1627726|NCT02174627|2989325|Superiority|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0.|LS Mean Difference|0.5|Standard Error of the Mean|0.013|<|0.001|2-Sided|95.0|0.47|0.52|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; ANCOVA model.|
1627727|NCT02174627|2989326|Superiority|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% CI of the difference between roxadustat and placebo exceeded 0 g/dL.|LS Mean Difference|1.13|Standard Error of the Mean|0.112|<|0.001|2-Sided|95.0|0.91|1.35|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; MAR-based multiple imputation ANCOVA model.|
1627728|NCT02174627|2989327|Superiority||Relative Risk|9.12|||<|0.001|2-Sided|95.0|7.63|10.89|||Cochran-Mantel-Haenszel|||Comparison of the percentage of responders for roxadustat versus placebo was analysed using a Cochran-Mantel-Haenszel test adjusting for baseline Hb, baseline eGFR, geographic region and CV history.|
1627729|NCT02174627|2989328|Superiority|Superiority of roxadustat compared with placebo would be declared if the lower bound of the 2-sided 95% confidence interval (CI) of the difference between roxadustat and placebo exceeded 0 g/dL.|LS Mean Difference|1.35|Standard Error of the Mean|0.041|<|0.001|2-Sided|95.0|1.27|1.43|||ANCOVA|||Difference between groups (roxadustat minus placebo) in LS mean changes; MAR-based multiple imputation ANCOVA model.|
1627730|NCT02174276|2989378|Superiority|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|-0.056||||0.426|2-Sided|95.0|-0.194|0.082|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.|
1627731|NCT02174276|2989378|Superiority|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|0.063||||0.37|2-Sided|95.0|-0.075|0.202|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.|
1627732|NCT02174276|2989378|Superiority|Estimated differences in treatment effects between GS-4774 treatment groups and the TDF only group at Week 24 are presented with the 95% CIs and unadjusted P-values.|Least Square Mean Difference|-0.017||||0.805|2-Sided|95.0|-0.155|0.12|||Mixed-Effect Model for Repeated Measures|||The null hypotheses was that the mean change from baseline in serum HBsAg in each of the TDF + GS-4774 groups was equal to the mean change from baseline in serum HBsAg in the TDF only group. Each null hypothesis was tested against the 2-sided alternative hypothesis that the mean change from baseline in serum HBsAg was not equal between each of the respective GS-4774 dose groups and the TDF only group.|
1627733|NCT02173704|2989403|Non-Inferiority or Equivalence|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 75%.|Single binomial proportion|94.0|||||2-Sided|95.0|88.7|97.4||||||Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the secondary objective for strain NZ98/254 was 99%.|
1627734|NCT02173704|2989403|Non-Inferiority or Equivalence|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 75%.|Single binomial proportion|99.0|||||2-Sided|95.0|94.7|99.82||||||Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the secondary objective for strain 5/99 was 99%.|
1627735|NCT02173704|2989403|Non-Inferiority or Equivalence|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 70%.|Single binomial proportion|99.0|||||2-Sided|95.0|95.7|99.98||||||"Statistical analysis H44/76 strain: The null hypothesis associated with the primary objective is that the proportion of subjects with hSBA titers~≥ 1:5 one month after the third dose of the Bexsero® vaccine was ≤ 0.70. Assuming the results for the three strains are independent, the power to reject the null hypothesis associated with the primary objectives to demonstrate sufficiency of response (for all three strains was 92%."|
1627767|NCT02172625|2989619|Superiority or Other||week-to-week coefficient of variation %|15.0|||||2-Sided||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.||
1627736|NCT02173704|2989404|Non-Inferiority or Equivalence|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥ 1:5 should be ≥ 70%.|single binomial proportion|79.0|||||2-Sided|95.0|71.4|85.8||||||Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the primary objective for strain NZ98/25 was 94%.|
1627737|NCT02173704|2989404|Non-Inferiority or Equivalence|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 70%.|Single binomial proportion|100.0|||||2-Sided|95.0|97.2|100.0||||||Statistical analysis 5/99 strain: The power to reject the null hypothesis associated with the primary objective for strain 5/99 was 99%.|
1627738|NCT02173704|2989404|Non-Inferiority or Equivalence|Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:5 should be ≥ 70%.|Single binomial proportion|100.0|||||2-Sided|95.0|97.2|100.0||||||Statistical analysis H44/76 strain: The null hypothesis associated with the primary objective is that the proportion of subjects with hSBA titers ≥ 1:5 one month after the third dose of the Bexsero® vaccine was ≤ 0.70. Assuming the results for the three strains are independent, the power to reject the null hypothesis associated with the primary objectives to demonstrate sufficiency of response (for all three strains was 92 %).|
1627739|NCT02173379|2989584|Non-Inferiority|One-sided p-value by using Farrington-Manning non-inferiority test statistic with non-inferiority margin of 2.9%, to be compared with a one-sided significance level of 0.025.||||||0.0244|||||||Farrington-Manning|||"The hypothesis test is designed to show non-inferiority of Absorb BVS to XIENCE for the primary endpoint with a one-sided alpha of 0.025. The null (H0) and alternative (HA) hypotheses are:~H0: TLFAbsorb - TLFXIENCE ≥ ∆TLF HA: TLFAbsorb - TLFXIENCE < ∆TLF."|
1627740|NCT02173054|2989595|Superiority or Other|||||||0.001||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test||||
1627741|NCT02173054|2989595|Superiority or Other|||||||0.606||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test||||
1627742|NCT02173054|2989595|Superiority or Other|||||||0.005||||||This statistical analysis was used to evaluate the change in ASI score at baseline and 8th week.|wilcoxan signed ranks test||||
1627743|NCT02173054|2989596|Superiority or Other|||||||0.123||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with Eucerin group.|Paired t-test||||
1627744|NCT02173054|2989596|Superiority or Other|||||||0.007||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel with placebo moisturizer group.|Paired t-test||||
1627745|NCT02173054|2989596|Superiority or Other|||||||0.0002||||||This statistical analysis was used to evaluate the change in TEWL at baseline and 8th week of the Adapalene gel group.|Paired t-test||||
1627746|NCT02173054|2989597|Superiority or Other|||||||0.735||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with Eucerin group.|Paired t-test||||
1627747|NCT02173054|2989597|Superiority or Other|||||||0.273||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel with placebo moisturizer group|Paired t-test||||
1627748|NCT02173054|2989597|Superiority or Other|||||||0.978||||||This statistical analysis was used to evaluate the change in skin hydration at baseline and 8th week of the Adapalene gel group|Paired t-test||||
1627749|NCT02173054|2989597|Superiority or Other|||||||0.134||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with Eucerin group|Paired t-test||||
1627750|NCT02173054|2989597|Superiority or Other|||||||0.167||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel with placebo moisturizer group|Paired t-test||||
1627751|NCT02173054|2989597|Superiority or Other|||||||0.078||||||This statistical analysis was used to evaluate the change in skin sebum content at baseline and 8th week of the Adapalene gel group|Paired t-test||||
1627752|NCT02173054|2989598|Superiority or Other|||||||0.16||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test||||
1627753|NCT02173054|2989598|Superiority or Other|||||||0.576||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test||||
1627754|NCT02173054|2989598|Superiority or Other|||||||0.205||||||This statistical analysis was used to evaluate the change in non inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test||||
1627755|NCT02173054|2989598|Superiority or Other|||||||0.003||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test||||
1627756|NCT02173054|2989598|Superiority or Other|||||||0.755||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test||||
1627757|NCT02173054|2989598|Superiority or Other|||||||0.001||||||This statistical analysis was used to evaluate the change in inflammatory lesion counts at baseline and 8th week.|wilcoxan signed ranks test||||
1627758|NCT02173054|2989598|Superiority or Other|||||||0.028||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week.|wilcoxan signed ranks test||||
1627759|NCT02173054|2989598|Superiority or Other|||||||0.697||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week|wilcoxan signed ranks test||||
1627760|NCT02173054|2989598|Superiority or Other|||||||0.059||||||This statistical analysis was used to evaluate the change in total lesion counts at baseline and 8th week|wilcoxan signed ranks test||||
1627761|NCT02173054|2989599|Superiority or Other|||||||0.449||||||This statistical analysis was used to compare number of participants who had pruritus among 3 groups.|Kruskal-Wallis||||
1627762|NCT02173054|2989599|Superiority or Other|||||||0.571||||||This statistical analysis was used to compare number of participants who had stinging among 3 groups.|Kruskal-Wallis||||
1627763|NCT02173054|2989599|Superiority or Other|||||||0.025||||||This statistical analysis was used to compare number of participants who had scaling among 3 groups.|Kruskal-Wallis||||
1627768|NCT02172625|2989620|Superiority or Other||week-to-week coefficient of variation %|26.0|||||2-Sided||||||||This was the week-to-week coefficient of variation (CV) obtained at baseline over two different weeks in a fasted state measured at rest.||
1627769|NCT02172040|2989622|Superiority||||||=|0|||||||t-test, 1 sided||||
1627770|NCT02172040|2989622|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627771|NCT02172040|2989622|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627772|NCT02172040|2989622|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627773|NCT02172040|2989623|Other||||||=|0|||||||t-test, 1 sided||||
1627774|NCT02172040|2989624|Other||||||<|0.001|||||||t-test, 1 sided||||
1627775|NCT02172040|2989625|Other||||||=|0|||||||t-test, 1 sided||||
1627776|NCT02172040|2989626|Other||||||<|0.001|||||||t-test, 1 sided||||
1627777|NCT02172040|2989627|Superiority||||||=|0|||||||t-test, 1 sided||||
1627778|NCT02172040|2989627|Superiority||||||=|0|||||||t-test, 1 sided||||
1627779|NCT02172040|2989627|Superiority||||||=|0|||||||t-test, 1 sided||||
1627780|NCT02172040|2989627|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627781|NCT02172040|2989627|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627782|NCT02172040|2989627|Superiority||||||=|0|||||||t-test, 1 sided||||
1627783|NCT02172040|2989628|Superiority||||||=|0|||||||t-test, 1 sided||||
1627784|NCT02172040|2989628|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627785|NCT02172040|2989628|Superiority||||||=|0|||||||t-test, 1 sided||||
1627786|NCT02172040|2989628|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627787|NCT02172040|2989628|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627788|NCT02172040|2989628|Superiority||||||=|0|||||||t-test, 1 sided||||
1627789|NCT02172040|2989629|Superiority||||||=|0|||||||t-test, 1 sided||||
1627790|NCT02172040|2989629|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627791|NCT02172040|2989629|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627792|NCT02172040|2989629|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627793|NCT02172040|2989629|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627794|NCT02172040|2989629|Superiority||||||=|0|||||||t-test, 1 sided||||
1627795|NCT02172040|2989630|Superiority||||||=|0|||||||t-test, 1 sided||||
1627796|NCT02172040|2989630|Superiority||||||=|0|||||||t-test, 1 sided||||
1627797|NCT02172040|2989630|Superiority||||||=|0|||||||t-test, 1 sided||||
1627798|NCT02172040|2989630|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627799|NCT02172040|2989630|Superiority||||||=|0|||||||t-test, 1 sided||||
1627800|NCT02172040|2989630|Superiority||||||=|0|||||||t-test, 1 sided||||
1627801|NCT02172040|2989631|Superiority||||||=|0|||||||t-test, 1 sided||||
1627802|NCT02172040|2989631|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627803|NCT02172040|2989631|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627804|NCT02172040|2989631|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627805|NCT02172040|2989631|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1627806|NCT02172040|2989631|Superiority||||||<|0.177|||||||t-test, 1 sided||||
1627807|NCT02172040|2989632|Other||||||=|0|||||||Chi-squared||||
1627808|NCT02172040|2989633|Superiority||||||=|0|||||||t-test, 1 sided|||A serial gatekeeping strategy was used for the primary efficacy endpoint analysis. The secondary comparison was a two-sample t-test to test the one-sided hypothesis that treatment with placebo was superior to treatment with celecoxib. This was only to be performed if statistical significance was achieved for the primary comparison.|
1627809|NCT02172040|2989633|Non-Inferiority|Non-inferiority margin definition: lower limit of the 95% confidence interval (CI) for amlodipine + celecoxib arm did not cross the 50% value for the amlodipine arm.|||||=|0|||||||t-test, 1 sided|||A serial gatekeeping strategy was used for the primary efficacy endpoint analysis. The primary comparison was a two-sample t-test to test the one-sided hypothesis that treatment with amlodipine + celecoxib was non-inferior to half of the effect achieved with amlodipine.|
1627810|NCT02171611|2989657|Superiority or Other||Ratio of adjusted geometric means in %|164.01|Standard Error of the Mean|51.7|||2-Sided|90.0|132.421|203.14|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|
1627811|NCT02171611|2989657|Superiority or Other||Ratio of adjusted geometric means in %|182.25|Standard Error of the Mean|55.7|||2-Sided|90.0|144.993|229.075|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|
1627812|NCT02171611|2989658|Superiority or Other||Ratio of adjusted geometric means in %|160.74|Standard Error of the Mean|52.0|||2-Sided|90.0|129.633|199.306|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|
1627828|NCT02170779|2989694|Superiority or Other|||||||0.144|||||||Wilcoxon (Mann-Whitney)|||This analysis refers to the physical component of the MSIS-29|
1627829|NCT02170779|2989695|Superiority or Other|||||||0.492|||||||Wilcoxon (Mann-Whitney)||||
1627813|NCT02171611|2989658|Superiority or Other||Ratio of adjusted geometric means in %|182.17|Standard Error of the Mean|56.1|||2-Sided|90.0|144.727|229.297|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|
1627814|NCT02171611|2989659|Superiority or Other||Ratio of adjusted geometric means in %|166.83|Standard Error of the Mean|52.6|||2-Sided|90.0|134.25|207.328|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual geometric coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|
1627815|NCT02171611|2989659|Superiority or Other||Ratio of adjusted geometric means in %|181.6|Standard Error of the Mean|53.9|||2-Sided|90.0|145.428|226.776|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|
1627816|NCT02171611|2989660|Superiority or Other||Ratio of adjusted geometric means in %|166.59|Standard Error of the Mean|54.3|||2-Sided|90.0|133.221|208.326|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|
1627817|NCT02171611|2989660|Superiority or Other||Ratio of adjusted geometric means|186.94|Standard Error of the Mean|57.7|||2-Sided|90.0|147.659|236.665|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|
1627818|NCT02171611|2989661|Superiority or Other||Ratio of adjusted geometric means in %|158.12|Standard Error of the Mean|46.7|||2-Sided|90.0|130.052|192.255|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|
1627819|NCT02171611|2989661|Superiority or Other||Ratio of adjusted geometric means in %|175.4|Standard Error of the Mean|51.1|||2-Sided|90.0|141.924|216.772|||||Relative bioavailability was estimated by the ratio of the gMean of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|
1627820|NCT02171611|2989662|Superiority or Other||Ratio of adjusted geometric means|154.84|Standard Error of the Mean|46.6|||2-Sided|90.0|127.425|188.161|||||Relative bioavailability was estimated by the ratio of the geometric means (gMeans) of Dabigatran etexilate 150 mg (T2) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual gCV.|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment (T2) vs. the Reference treatment (R). This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|
1627821|NCT02171611|2989662|Superiority or Other||Ratio of adjusted geometric means|175.14|Standard Error of the Mean|50.7|||2-Sided|90.0|141.904|216.149|||||Relative bioavailability was estimated by the ratio of the gMeans of Dabigatran etexilate 150 mg (T1) divided by Dabigatran etexilate 150 mg (R). Standard Error of the mean is actually the intra individual coefficient variation (gCV).|An Analysis of variance (ANOVA) model was used on the logarithmic scale in order to compare the Test treatment vs. the Reference treatment. This model included effects for 'sequence', 'subjects within sequences', 'period' and 'treatment'. The effect 'subjects within sequences' was considered as random, whereas the other effects were considered as fixed.|
1627822|NCT02170870|2989690|Superiority|||||||0.0001|||||||ANOVA|||Mean GI symptom score during lipid infusion in controls vs functional dyspepsia adjusted for treatment status (ie, exendin or placebo)|
1627823|NCT02170870|2989690|Superiority|||||||0.06|||||||ANOVA|||Mean GI symptom score during lipid infusion in controls vs diabetics adjusted for treatment status (ie, exendin or placebo)|
1627824|NCT02170779|2989691|Superiority or Other|||||||0.11|||||||Wilcoxon (Mann-Whitney)||||
1627825|NCT02170779|2989692|Superiority or Other|||||||0.023|||||||Wilcoxon (Mann-Whitney)||||
1627826|NCT02170779|2989693|Superiority or Other|||||||0.915|||||||Wilcoxon (Mann-Whitney)||||
1627827|NCT02170779|2989694|Superiority or Other|||||||0.953|||||||Wilcoxon (Mann-Whitney)|||This refers to the psychological analysis for the MSIS-29.|
1627830|NCT02170779|2989696|Superiority or Other|||||||0.638|||||||Wilcoxon (Mann-Whitney)||||
1627834|NCT02170025|2989778|Other||Bayesian analysis|-5.0|||||2-Sided|90.0|-12.4|2.4||||||Treatment effect describes the difference in outcomes between 1.0 mg riociguat and placebo on Day 28. This was an exploratory analysis. For sample size determination a probabilistic assessment on predicted point estimates and width of credible intervals was performed.|
1627835|NCT02170025|2989778|Other||Bayesian analysis|-1.3|||||2-Sided|90.0|-8.7|6.0||||||Treatment effect describes the difference in outcomes between 0.5 mg riociguat and placebo on Day 14. This was an exploratory analysis. For sample size determination a probabilistic assessment on predicted point estimates and width of credible intervals was performed.|
1627836|NCT02169115|2989853|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Deviation|1.4|||2-Sided||||||||||
1627837|NCT02169115|2989853|Superiority or Other||Mean Difference (Final Values)|2.0|Standard Deviation|1.8||0.005|2-Sided||||||ANOVA||||
1627838|NCT02169115|2989853|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Deviation|1.7||0.05|2-Sided||||||ANOVA||||
1627839|NCT02168855|2989872|Superiority||Odds Ratio (OR)|0.19|||<|0.0001|2-Sided|95.0|0.15|0.23|||Regression, Logistic||Odds ratio where temptations are the numerator and background is the denominator, that no other people were seen smoking nearby.||
1627840|NCT02168855|2989873|Superiority||Odds Ratio (OR)|0.18|||<|0.0001|2-Sided|95.0|0.14|0.21|||Regression, Logistic|Includes random subject intercept effect|Odds ratio where temptations are the numerator and background is the denominator, that no smoking cues were seen.||
1627841|NCT02168855|2989874|Superiority||Odds Ratio (OR)|1.66|||<|0.0001|2-Sided|95.0|1.51|1.83|||Mixed Models Analysis|Includes random subject intercept effect|Reflects an odds ratio relative to a 10-unit increase in negative affect T-score. Temptations are the numerator and background is the denominator.||
1627842|NCT02168855|2989875|Superiority||Odds Ratio (OR)|1.9|||<|0.0001|2-Sided|95.0|1.83|1.98|||Mixed Models Analysis|Includes random subject intercept effect|Reflects an odds ratio relative to a 10-unit increase in craving. Temptations are the numerator and background is the denominator.||
1627843|NCT02168855|2989876|Superiority||Odds Ratio (OR)|1.39||||0.46|2-Sided|95.0|0.58|3.29|||Regression, Logistic|This is a logistic regression model of the active versus placebo arm, while controlling for age and cigarettes smoked per day at enrollment.|The active arm is the numerator and the placebo arm is the denominator of the odds ratio||
1627844|NCT02168842|2989884|Equivalence|Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.|Hazard Ratio (HR)|0.83||||0.35|2-Sided|95.0|0.56|1.22|||Log Rank||||
1627845|NCT02168842|2989885|Equivalence|Comparison the risk of need for dyskinesia in Isradipine group to the risk in a placebo group.|Hazard Ratio (HR)|1.53||||0.21|2-Sided|95.0|0.78|3.01|||Log Rank||||
1627846|NCT02168842|2989886|Equivalence|Comparison of the risk of need for antiparkinsonian therapy in Isradipine group to the risk in placebo group.|Hazard Ratio (HR)|0.79||||0.073|2-Sided|95.0|0.61|1.03|||Log Rank||||
1627847|NCT02168491|2989939|Superiority or Other|||||||0.28|||||||paired t test||||
1627848|NCT02168491|2989940|Superiority or Other|||||||0.24|||||||paired t test||||
1627849|NCT02168491|2989941|Superiority or Other||||||<|0.02|||||||paired t test||||
1627850|NCT02168361|2989953|Superiority or Other|||||||0.02|||||||Chi-squared|||Null hypothesis is no difference between two regimens in SVR-12.|
1627851|NCT02168153|2989960|Superiority||Mean Difference (Final Values)|-0.41||||0.32|2-Sided|95.0|-1.24|0.41|||ANCOVA|adjusted for age||Between group differences|
1627852|NCT02168153|2989961|Superiority||Mean Difference (Final Values)|0.988||||0.15|2-Sided|95.0|-0.373|2.349|||ANCOVA|adjusted for age||Between group differences|
1627853|NCT02168153|2989962|Superiority||Mean Difference (Final Values)|3.49||||0.7|2-Sided|95.0|-14.4|21.39|||ANCOVA|adjusted for age||Between group differences|
1627854|NCT02168153|2989963|Superiority||Mean Difference (Final Values)|0.97||||0.92|2-Sided|95.0|-18.04|19.98|||ANCOVA|adjusted for age||Between group differences|
1627855|NCT02168153|2989964|Superiority||Mean Difference (Final Values)|-3.49||||0.76|2-Sided|95.0|-25.75|18.77|||ANCOVA|adjusted for age||Between group differences|
1627856|NCT02167867|2989977|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||t=+7.76|
1627857|NCT02167074|2990015|Other|The chi-square test (with Yates’ correction when appropriate) or the Fisher exact test was used to compare the two needle types|||||<|0.05|||||||Chi-squared||||
1627858|NCT02166476|2990040|Non-Inferiority or Equivalence|The noninferiority margin was a difference of 15%. Meropenem-vaborbactam was claimed to be noninferior only if noninferiority was demonstrated for microbial eradication at TOC in the ME Population.|Treatment Difference|5.9|||||2-Sided|95.0|-4.2|16.0|||||Treatment difference is the estimate of the difference in the overall success rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the ME population|
1627859|NCT02166476|2990041|Non-Inferiority or Equivalence|The noninferiority margin was a difference of 15%. Meropenem-vaborbactam was claimed to be noninferior only if noninferiority was demonstrated for microbial eradication at TOC in the m-MITT Population.|Treatment difference|9.0|||||2-Sided|95.0|-0.9|18.7|||||Treatment difference is the estimate of the difference in the Eradication rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the m-MITT population|
1627860|NCT02166476|2990042|Non-Inferiority or Equivalence|The noninferiority margin was a difference of 15%. Noninferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) for the treatment difference for overall success at EOIVT was >-15%.|Treatment difference|4.5|||||2-Sided|95.0|0.7|9.1|||||Treatment difference is the estimate of the difference in the overall success rate between the two treatment arms. The difference estimates and the 95% CIs are obtained based on Miettinen and Nurminen method.|Treatment comparison of the m-MITT population|
1627861|NCT02165826|2990077|Superiority or Other||Odds Ratio (OR)|0.78||||0.091|2-Sided|95.0|0.59|1.04||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.|
1627862|NCT02165826|2990077|Superiority or Other||Odds Ratio (OR)|0.63||||0.001|2-Sided|95.0|0.47|0.83||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.|
1627863|NCT02165826|2990078|Superiority or Other||Cox Proportional Hazard|0.77|||||2-Sided|95.0|0.58|1.02|||||Cox proportional hazards model with study treatment and country as class effects, and baseline FEV1 as a continuous variable.|Analyses were performed using a hierarchical testing procedure.|
1627864|NCT02165826|2990078|Superiority or Other||Odds Ratio (OR)|0.76||||0.114|2-Sided|95.0|0.55|1.07||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.|
1627865|NCT02165826|2990078|Superiority or Other||Cox Proportional Hazard|0.68|||||2-Sided|95.0|0.51|0.92|||||Cox proportional hazards model with study treatment and country as class effects, and baseline FEV1 as a continuous variable.|Analyses were performed using a hierarchical testing procedure.|
1627866|NCT02165826|2990078|Superiority or Other||Odds Ratio (OR)|0.66||||0.017|2-Sided|95.0|0.47|0.93||Study treatment, country and baseline forced expiratory volume in the first second (FEV1) as explanatory variables.|Regression, Logistic|||Analyses were performed using a hierarchical testing procedure.|
1627867|NCT02165722|2990091|Other|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared||||
1627868|NCT02165722|2990091|Other|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention between intervention and control clinics.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared||||
1627869|NCT02165722|2990091|Other|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.|||||>|0.05||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared||||
1627870|NCT02165722|2990091|Other|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.|||||>|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series completion vaccination rates from baseline to post-intervention.|||
1627871|NCT02165722|2990092|Other|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared||||
1627872|NCT02165722|2990092|Other|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|||Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention between intervention and control clinics.|
1627873|NCT02165722|2990092|Other|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||
1627874|NCT02165722|2990092|Other|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||||<|0.001||||||Statistical significance for two-sided tests was set at a type I error (alpha) equal to 0.05.|Chi-squared|Chi-square tests performed to test for differences in cumulative HPV series initiation vaccination rates from baseline to post-intervention.|||
1627875|NCT02164981|2990140|Superiority||Mean Difference (Final Values)|2.05||||0.36|2-Sided||||||ANCOVA||||
1627876|NCT02164981|2990140|Superiority||Mean Difference (Final Values)|1.11||||0.34|2-Sided||||||ANCOVA||||
1627877|NCT02164981|2990143|Superiority||Mean Difference (Final Values)|1.1||||0.34|2-Sided||||||ANCOVA||||
1627878|NCT02164981|2990143|Superiority||Mean Difference (Final Values)|1.12||||0.33|2-Sided||||||ANCOVA||||
1627879|NCT02164981|2990149|Superiority||Mean Difference (Final Values)|-0.23||||0.83|2-Sided||||||ANCOVA||||
1627880|NCT02164981|2990149|Superiority||Mean Difference (Final Values)|-0.19||||0.86|2-Sided||||||ANCOVA||||
1627881|NCT02164981|2990150|Superiority||Mean Difference (Final Values)|-0.1||||0.88|2-Sided||||||ANCOVA||||
1627882|NCT02164981|2990150|Superiority||Mean Difference (Final Values)|-0.12||||0.85|2-Sided||||||ANCOVA||||
1627883|NCT02164981|2990151|Superiority||Mean Difference (Final Values)|-0.62||||0.37|2-Sided|||||Exploratory efficacy outcome, hence no adjustment for multiple comparisons|ANCOVA||||
1627884|NCT02164981|2990151|Superiority||Mean Difference (Final Values)|-0.62||||0.35|2-Sided|||||Exploratory efficacy outcome, hence no adjustment for multiple comparison.|ANCOVA||||
1627885|NCT02164981|2990152|Superiority||Mean Difference (Final Values)|-1.09||||0.54|2-Sided|||||No adjustment for multiple comparisons, as there was only one primary outcome variable.|ANCOVA|||The same analysis as in Analysis 1 was conducted, except that CLOZAPINE (i.e., patient used clozapine vs. other antipsychotic) was added as a covariate.|
1627886|NCT02164981|2990152|Superiority||Mean Difference (Final Values)|-1.04||||0.57|2-Sided|||||No adjustment for multiple comparisons, as there was only one primary outcome variable.|ANCOVA|||Given the sequential parallel comparison design (SPCD), we used a two-stage test (weighted z-test, Tamura approach: CHANGE_score = BASELINE_value + GROUP (i.e., SNP vs. placebo)) to combine the data on treatment effects from phases 1 and 2 (weighted equally). Assessments were on Day -1 (phase 1 baseline), Day 13 (phase 1 outcome, phase 2 baseline) and Day 28 (phase 2 outcome). Only participants who at least started the infusion were included in analysis (i.e., modified intent to treat).|
1627887|NCT02164916|2990168|Superiority||Hazard Ratio (HR)|0.48||||0.001|2-Sided|95.0|0.31|0.75|||Log Rank||||
1627888|NCT02164864|2990169|Other||Hazard Ratio (HR)|0.89||||0.4432|2-Sided|95.0|0.67|1.19||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627889|NCT02164864|2990169|Other||Hazard Ratio (HR)|1.13||||0.3002|2-Sided|95.0|0.9|1.43||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627890|NCT02164864|2990169|Non-Inferiority|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|1.04||||0.0047|2-Sided|95.0|0.84|1.29||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|The upper bound of the Wald confidence interval (CI) of the HR of All Dabigatran Etexilate (110mg and 150 mg) vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority|A pre-defined hierarchical testing approach was used. This was the third step in hierarchy.|
1627891|NCT02164864|2990170|Other||Hazard Ratio (HR)|0.96||||0.8348|2-Sided|95.0|0.65|1.41||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627892|NCT02164864|2990170|Other||Hazard Ratio (HR)|1.09||||0.608|2-Sided|95.0|0.79|1.51||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627893|NCT02164864|2990171|Other||Hazard Ratio (HR)|0.97||||0.875|2-Sided|95.0|0.68|1.39||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627894|NCT02164864|2990171|Other||Hazard Ratio (HR)|1.3||||0.072|2-Sided|95.0|0.98|1.73||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627895|NCT02164864|2990171|Non-Inferiority|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|1.17||||0.1128|2-Sided|95.0|0.9|1.53||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|The upper bound of the Wald confidence interval (CI) of the HR of All Dabigatran Etexilate (110mg and 150 mg) vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority|A pre-defined hierarchical testing approach was used. This was the fifth step in hierarchy.|
1627896|NCT02164864|2990172|Other||Hazard Ratio (HR)|1.03||||0.8903|2-Sided|95.0|0.71|1.47||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627897|NCT02164864|2990172|Other||Hazard Ratio (HR)|1.34||||0.0484|2-Sided|95.0|1.0|1.79||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627898|NCT02164864|2990173|Other||Hazard Ratio (HR)|0.99||||0.9789|2-Sided|95.0|0.35|2.81||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627899|NCT02164864|2990173|Other||Hazard Ratio (HR)|1.86||||0.1546|2-Sided|95.0|0.79|4.4||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627900|NCT02164864|2990174|Other||Hazard Ratio (HR)|0.3||||0.303|2-Sided|95.0|0.03|2.93||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627901|NCT02164864|2990174|Other||Hazard Ratio (HR)|0.94||||0.9388|2-Sided|95.0|0.19|4.66||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627902|NCT02164864|2990175|Other||Hazard Ratio (HR)|1.09||||0.8537|2-Sided|95.0|0.42|2.83||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627903|NCT02164864|2990175|Other||Hazard Ratio (HR)|1.3||||0.4803|2-Sided|95.0|0.63|2.67||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627904|NCT02164864|2990176|Other||Hazard Ratio (HR)|1.16||||0.6144|2-Sided|95.0|0.66|2.04||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627905|NCT02164864|2990176|Other|Wald 2-sided p-value from (stratified) Cox proportional hazards model|Hazard Ratio (HR)|1.51||||0.0861|2-Sided|95.0|0.94|2.41|||Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627906|NCT02164864|2990177|Other||Hazard Ratio (HR)|0.83||||0.4414|2-Sided|95.0|0.51|1.34||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627907|NCT02164864|2990177|Other||Hazard Ratio (HR)|1.12||||0.5579|2-Sided|95.0|0.76|1.65||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627908|NCT02164864|2990178|Other||Hazard Ratio (HR)|0.84||||0.567|2-Sided|95.0|0.47|1.51||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627909|NCT02164864|2990178|Other||Hazard Ratio (HR)|1.17||||0.5252|2-Sided|95.0|0.72|1.88||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627910|NCT02164864|2990179|Other||Hazard Ratio (HR)|0.49||||0.238|2-Sided|95.0|0.15|1.61||Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627911|NCT02164864|2990179|Other||Hazard Ratio (HR)|1.06||||0.8853|2-Sided|95.0|0.5|2.25||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627912|NCT02164864|2990180|Other|Wald 2-sided p-value from (unstratified) Cox proportional hazards model|Hazard Ratio (HR)|1.59||||0.5277|2-Sided|95.0|0.38|6.64|||Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded from|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627913|NCT02164864|2990180|Other||Hazard Ratio (HR)|0.99||||0.9862|2-Sided|95.0|0.25|3.95||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model||
1627914|NCT02164864|2990181|Superiority||Hazard Ratio (HR)|0.72||||0.002|2-Sided|95.0|0.58|0.88||unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Regression, Cox|Wald 2-sided p-value from (unstratified) Cox proportional hazards model||A pre-defined hierarchical testing approach was used. This was the sixth step in hierarchy.|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model
1627915|NCT02164864|2990181|Superiority||Hazard Ratio (HR)|0.52|||<|0.001|2-Sided|95.0|0.42|0.63||Wald 2-sided p-value from (stratified) Cox proportional hazards model|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the fourth step in hierarchy.|
1627916|NCT02164864|2990181|Non-Inferiority|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|0.72|||<|0.0001|2-Sided|95.0|0.58|0.88||P-values for non-inferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|unstratified Cox proportional hazards model was used and elderly patients outside the USA were excluded|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the second step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 150mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority|
1627917|NCT02164864|2990181|Non-Inferiority|All non-inferiority tests were based on a margin of 1.38.|Hazard Ratio (HR)|0.52|||<|0.0001|2-Sided|95.0|0.42|0.63||P values for noninferiority were calculated at a one-sided alpha level of 0.025|Regression, Cox|The Cox proportional hazard model is stratified by age, non−elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].|Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model|A pre-defined hierarchical testing approach was used. This was the first step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 110mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority.|
1627918|NCT02164539|2990189|Superiority or Other||Mean Difference (Net)|-0.163|||<|0.001|2-Sided|95.0|-0.227|-0.099|||ANCOVA||||
1627919|NCT02164539|2990189|Superiority or Other||Mean Difference (Net)|-0.06|||<|0.066|2-Sided|95.0|-0.124|0.004|||ANCOVA||||
1627920|NCT02164539|2990189|Superiority or Other||Mean Difference (Net)|-0.089|||<|0.017|2-Sided|95.0|-0.162|-0.016|||ANCOVA||||
1627921|NCT02164539|2990189|Superiority or Other||Mean Difference (Net)|-0.091|||<|0.017|2-Sided|95.0|-0.165|-0.016|||ANCOVA||||
1627922|NCT02164539|2990189|Superiority or Other||Mean Difference (Net)|-0.088|||<|0.019|2-Sided|95.0|-0.162|-0.014|||ANCOVA||||
1627923|NCT02164539|2990190|Superiority or Other||Mean Difference (Net)|0.076||||0.031|2-Sided|95.0|0.007|0.146|||ANCOVA||||
1627924|NCT02164539|2990190|Superiority or Other||Mean Difference (Net)|0.005||||0.895|2-Sided|95.0|-0.065|0.075|||ANCOVA||||
1627925|NCT02164539|2990190|Superiority or Other||Mean Difference (Net)|0.025||||0.534|2-Sided|95.0|-0.054|0.103|||ANCOVA||||
1627926|NCT02164539|2990190|Superiority or Other||Mean Difference (Net)|0.04||||0.328|2-Sided|95.0|-0.041|0.121|||ANCOVA||||
1627927|NCT02164539|2990190|Superiority or Other||Mean Difference (Net)|0.045||||0.264|2-Sided|95.0|-0.034|0.125|||ANCOVA||||
1627928|NCT02164539|2990191|Superiority or Other||Mean Difference (Net)|18.5|||<|0.001|2-Sided|95.0|8.0|29.1|||ANCOVA||||
1627929|NCT02164539|2990191|Superiority or Other||Mean Difference (Net)|24.8|||<|0.001|2-Sided|95.0|14.1|35.4|||ANCOVA||||
1627932|NCT02164539|2990191|Superiority or Other||Mean Difference (Net)|18.1|||<|0.004||95.0|5.9|30.3|||ANCOVA||||
1627933|NCT02164539|2990192|Superiority or Other||Mean Difference (Net)|-1.7||||0.009|2-Sided|95.0|-2.9|-0.4|||ANCOVA||||
1627934|NCT02164539|2990192|Superiority or Other||Mean Difference (Net)|-2.0||||0.002|2-Sided|95.0|-3.2|-0.7|||ANCOVA||||
1627935|NCT02164539|2990192|Superiority or Other||Mean Difference (Net)|-2.0||||0.007|2-Sided|95.0|-3.4|-0.6|||ANCOVA||||
1627936|NCT02164539|2990192|Superiority or Other||Mean Difference (Net)|-3.0|||<|0.001|2-Sided|95.0|-4.5|-1.6|||ANCOVA||||
1627937|NCT02164539|2990192|Superiority or Other||Mean Difference (Net)|-3.1|||<|0.001|2-Sided|95.0|-4.6|-1.7|||ANCOVA||||
1627938|NCT02164539|2990193|Superiority or Other||Mean Difference (Net)|-0.7||||0.031|2-Sided|95.0|-1.4|-0.1|||ANCOVA||Statistical analysis presented for daily rescue medication use.||
1627939|NCT02164539|2990193|Superiority or Other||Mean Difference (Net)|-0.8||||0.014|2-Sided|95.0|-1.5|-0.2|||ANCOVA||Statistical analysis presented for daily rescue medication use.||
1627940|NCT02164539|2990193|Superiority or Other||Mean Difference (Net)|-0.7||||0.083|2-Sided|95.0|-1.4|0.1|||ANCOVA||Statistical analysis presented for daily rescue medication use.||
1627941|NCT02164539|2990193|Superiority or Other||Mean Difference (Net)|-1.1||||0.004|2-Sided|95.0|-1.9|-0.4|||ANCOVA||Statistical analysis presented for daily rescue medication use.||
1627942|NCT02164539|2990193|Superiority or Other||Mean Difference (Net)|-1.0||||0.01|2-Sided|95.0|-1.7|-0.2|||ANCOVA||||
1627943|NCT02164539|2990194|Superiority or Other||Mean Difference (Net)|0.073||||0.152|2-Sided|95.0|-0.027|0.172|||Final dose response model||||
1627944|NCT02164539|2990194|Superiority or Other||Mean Difference (Net)|0.103||||0.024|2-Sided|95.0|0.014|0.193|||Final step dose response model||||
1627945|NCT02164539|2990194|Superiority or Other||Mean Difference (Net)|0.103||||0.024|2-Sided|95.0|0.014|0.193|||Final step dose response model||||
1627946|NCT02164539|2990194|Superiority or Other||Mean Difference (Net)|0.103||||0.024|2-Sided|95.0|0.014|0.193|||Final step dose response model||||
1627947|NCT02164539|2990194|Superiority or Other||Mean Difference (Net)|0.103||||0.024|2-Sided|95.0|0.014|0.193|||Final step dose response model||||
1627948|NCT02164513|2990195|Superiority||Rate ratio|0.66|||<|0.001|2-Sided|95.0|0.56|0.78|||Negative binomial model||||
1627949|NCT02164513|2990195|Superiority||Rate Ratio|0.87|||<|0.064|2-Sided|95.0|0.76|1.01|||Negative binomial model||||
1627950|NCT02164513|2990196|Superiority||Hazard Ratio (HR)|0.77|||<|0.001|2-Sided|95.0|0.7|0.85|||Cox proportional hazard model||||
1627951|NCT02164513|2990197|Superiority||Rate ratio|0.68|||<|0.001|2-Sided|95.0|0.62|0.75|||Negative binomial Model||||
1627952|NCT02164513|2990198|Superiority||Hazard Ratio (HR)|0.84|||<|0.001|2-Sided|95.0|0.78|0.91|||Cox proportional hazard model||||
1627953|NCT02164513|2990198|Superiority||Hazard Ratio (HR)|0.85|||<|0.001|2-Sided|95.0|0.8|0.91||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons.|Cox proportional hazard model||||
1627954|NCT02164513|2990199|Superiority||Mean Difference (Net)|-1.8|Standard Error of the Mean|0.34|<|0.001|2-Sided|95.0|-2.4|-1.1||The adjusted p-value at Week 52 should be compared against a reference level of 0.05 in order to infer statistical significance for the comparison of FF/UMEC/VI vs FF/VI at Week 52.|Mixed Models Repeated Measures||||
1627955|NCT02164513|2990200|Superiority||Mean Difference (Net)|0.097|Standard Error of the Mean|0.0061|<|0.001|2-Sided|95.0|0.085|0.109||The adjusted p-value at Week 52 should be compared against a reference level of 0.05 in order to infer statistical significance for the comparison of FF/UMEC/VI versus (vs) FF/VI at Week 52.|Mixed Models Repeated Measures||||
1627956|NCT02164513|2990201|Superiority||Rate ratio|0.85|||<|0.001|2-Sided|95.0|0.8|0.9||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons|Negative binomial model||Covariates of treatment group, sex, exacerbation history (<=1, >=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted Forced expiratory volume in 1 second (FEV1) (Screening) were used.||
1627957|NCT02164513|2990201|Superiority||Rate ratio|0.75|||<|0.001|2-Sided|95.0|0.7|0.81||The adjusted p-values should be compared against a reference level of 0.05 in order to infer statistical significance for either of the comparisons.|Negative binomial model||Covariates of treatment group, sex, exacerbation history (<=1, >=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted Forced expiratory volume in 1 second (FEV1) (Screening) were used.||
1627958|NCT02164383|2990203|Superiority||Mean Difference (Final Values)|1.82||||0.85|2-Sided||||||ANOVA||ANOVA results: F(1,28)=.04, p=.85, partial eta-squared (as a measure of effect size) = .001||
1627959|NCT02164240|2990208|Other||Clinical Benefit Rate|0.0|||||2-Sided|95.0|0.0|24.7||||||Clinical benefit rate of at least 30% at 16 weeks for the entire, combined population, was considered worthy of further study.|
1627960|NCT02163993|2990222|Superiority||Posterior Mean Difference|-0.62|Standard Deviation|0.45|||2-Sided|95.0|-1.5|0.27|||||||
1627961|NCT02163993|2990222|Superiority||Posterior Mean Difference|-1.14|Standard Deviation|0.44|||2-Sided|95.0|-2.02|-0.29|||||||
1627962|NCT02163993|2990222|Superiority||Posterior Mean Difference|-0.25|Standard Deviation|0.41|||2-Sided|95.0|-1.06|0.56|||||||
1627963|NCT02163993|2990222|Superiority||Posterior Mean Difference|-0.57|Standard Deviation|0.42|||2-Sided|95.0|-1.4|0.24|||||||
1627964|NCT02163967|2990223|Other|||||||0.47||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.|||
1627965|NCT02163967|2990224|Other|||||||0.81||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons were made using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.|||
1628086|NCT02163577|2990290|Superiority||||||<|0.0001|||||||one sample t test|||Week 40|
1628898|NCT02145156|2992165|Superiority or Other|||||||0.22|||||||Fisher Exact||||
1627966|NCT02163967|2990225|Other||||||<|0.001|||||||Chi-squared|||The null hypothesis is that there will be no difference in the number of side effects reported during either dose of stimulation compared to sham stimulation. Statistical differences were examined for light flickering in peripheral vision . Other side effects were reported by too few subjects to be analyzed statistically.|
1627967|NCT02163967|2990226|Other||||||<|0.02||||||Mixed effects regression model, a nested (within subject) random intercept for dose, fixed effects for age, dose, time and dose x time interaction. Significance level p=.05, Bonferonni correction was used for post-hoc tests.|Regression, Linear|Post-hoc comparisons using least-square means. Kenward-Roger adjustments to denominator degrees of freedom.Increase in HRV at 2Amp compared to sham.||The null hypothesis is that there is no difference in High frequency HRV after 20 minutes of stimulation or 15 minutes after cessation of stimulation at the low (1mAmp) or high (2mAmp) dose compared to sham stimulation|
1627968|NCT02163837|2990243|Superiority|the study was exploratory, the number of patients included was not calculated|||||<|0.05|||||||McNemar|||Mc Nemar symetry test for repeated measures and paired t-tests as appropriated|
1627969|NCT02163733|2990252|Superiority or Other (legacy)||Geometric mean ratio|82.92|||||2-Sided|90.0|60.99|112.74|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 4.236, Fasted = 5.109.|AZ7550|
1627970|NCT02163733|2990252|Superiority or Other (legacy)||Geometric mean ratio|76.68|||||2-Sided|90.0|55.31|106.32|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 9.163, Fasted = 11.95.|AZ5104|
1627971|NCT02163733|2990253|Superiority or Other (legacy)||Geometric mean ratio|88.21|||||2-Sided|90.0|65.21|119.32|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 235.0, Fasted = 266.4.|AZ7550|
1627972|NCT02163733|2990253|Superiority or Other (legacy)||Geometric mean ratio|81.15|||||2-Sided|90.0|57.86|113.83|||||Fed / Fasted ratio. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis. Linear mixed-effects model with treatment as fixed effect. LSGMR Fed = 497.6, Fasted = 613.2.|AZ5104|
1627973|NCT02163733|2990261|Non-Inferiority or Equivalence (legacy)|90% CIs being within 70% to 143%|Geometric mean ratio|92.75|||||2-Sided|90.0|81.4|105.68|||||Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. LSGMR Fed = 208.0, Fasted = 224.3.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.|
1627974|NCT02163733|2990262|Non-Inferiority or Equivalence (legacy)|90% CIs being within 70% to 143%.|Geometric mean ratio|106.05|||||2-Sided|90.0|94.82|118.6|||||Fed / Fasted ratio. Linear mixed-effects model with sequence, period, and treatment as fixed effects and subject nested within sequence as a random effect. Least squares geometric mean ratio (LSGMR) Fed = 7847, Fasted = 7399.|Study sized so experiment-wise power for the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being within 70-143% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 6% change in exposure was also assumed.|
1627975|NCT02163577|2990266|Superiority||||||<|0.0001|||||||one sample t test|||Week 160|
1627976|NCT02163577|2990266|Superiority||||||<|0.0001|||||||one sample t test|||Week 160|
1627977|NCT02163577|2990266|Superiority||||||<|0.0001|||||||one sample t test|||Week 64|
1627978|NCT02163577|2990266|Superiority||||||<|0.0001|||||||one sample t test|||Week 64|
1627979|NCT02163577|2990266|Superiority||||||<|0.0021|||||||one sample t test|||Week 40|
1627980|NCT02163577|2990266|Superiority||||||<|0.0003|||||||one sample t test|||Week 40|
1627981|NCT02163577|2990270|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1627982|NCT02163577|2990270|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1627983|NCT02163577|2990270|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1627984|NCT02163577|2990270|Superiority||||||<|0.026||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1627985|NCT02163577|2990270|Superiority||||||<|0.0006||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1627986|NCT02163577|2990270|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1627987|NCT02163577|2990271|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1627988|NCT02163577|2990271|Superiority||||||<|0.0093||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1627989|NCT02163577|2990271|Superiority||||||<|0.0814||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1627990|NCT02163577|2990271|Superiority||||||<|0.2558||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1627991|NCT02163577|2990271|Superiority||||||<|0.1132||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1627992|NCT02163577|2990271|Superiority||||||<|0.223||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1627993|NCT02163577|2990272|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1627994|NCT02163577|2990272|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1627995|NCT02163577|2990272|Superiority||||||<|0.0002||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1627996|NCT02163577|2990272|Superiority||||||<|0.0536||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1627997|NCT02163577|2990272|Superiority||||||<|0.0028||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1627998|NCT02163577|2990272|Superiority||||||<|0.0014||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1627999|NCT02163577|2990273|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628000|NCT02163577|2990273|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628001|NCT02163577|2990273|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628002|NCT02163577|2990273|Superiority||||||<|0.0033||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628003|NCT02163577|2990273|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1628004|NCT02163577|2990273|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1628005|NCT02163577|2990274|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628006|NCT02163577|2990274|Superiority||||||<|0.5677||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628007|NCT02163577|2990274|Superiority||||||<|0.0016||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628008|NCT02163577|2990274|Superiority||||||<|0.9124||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628009|NCT02163577|2990274|Superiority||||||<|0.0251||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1628010|NCT02163577|2990274|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1628011|NCT02163577|2990275|Superiority|||||||0.2082||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628012|NCT02163577|2990275|Superiority|||||||0.9795||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628013|NCT02163577|2990275|Superiority|||||||0.0004||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628014|NCT02163577|2990275|Superiority|||||||0.0384||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628015|NCT02163577|2990275|Superiority|||||||0.0144||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1628199|NCT02161406|2990469|Superiority|||||||0.03|||||||Mixed Models Analysis||||
1628200|NCT02161406|2990470|Superiority|||||||0.73|||||||Mixed Models Analysis||||
1628016|NCT02163577|2990275|Superiority||||||<|0.0001||||||GEE model includes change in POSNA-PODCI score as the dependent variable, visit, regimen, visit by regimen as factors, and POSNA-PODCI at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1628017|NCT02163577|2990276|Superiority|||||||0.2654||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628018|NCT02163577|2990276|Superiority|||||||0.1865||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628019|NCT02163577|2990276|Superiority|||||||0.0327||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628020|NCT02163577|2990276|Superiority|||||||0.0007||||||GEE model included change in percent of predicted 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628021|NCT02163577|2990276|Superiority|||||||0.9098||||||GEE model included change in 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1628022|NCT02163577|2990276|Superiority|||||||0.0771||||||GEE model included change in 6MWT score as the dependent variable; visit, regimen, visit by regimen as factors; and 6MWT at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1628023|NCT02163577|2990281|Superiority|||||||0.0343||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 160|
1628024|NCT02163577|2990281|Superiority||||||<|0.0001||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 160|
1628025|NCT02163577|2990281|Superiority||||||<|0.0456||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 64|
1628026|NCT02163577|2990281|Superiority||||||<|0.0002||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 64|
1628027|NCT02163577|2990281|Superiority||||||<|0.0569||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 40|
1628028|NCT02163577|2990281|Superiority||||||<|0.0001||||||GEE model included change from baseline for standing height Z score as dependent variable; visit, regimen, visit by regimen, and gender as factors; and age and standing height Z score at baseline as covariates, with exchangeable covariance structure.|GEE model|||Week 40|
1628029|NCT02163577|2990282|Superiority|||||||0.4096|||||||one sample t test|||Week 112 to Week 160|
1628030|NCT02163577|2990282|Superiority|||||||0.1627|||||||one sample t test|||Week 112 to Week 160|
1628031|NCT02163577|2990282|Superiority|||||||0.8606|||||||one sample t test|||Week 64 to Week 112|
1628032|NCT02163577|2990282|Superiority|||||||0.5335|||||||one sample t test|||Week 64 to Week 112|
1628033|NCT02163577|2990282|Superiority|||||||0.4114|||||||one sample t test|||Week 0 to Week 64|
1628034|NCT02163577|2990282|Superiority|||||||0.016|||||||one sample t test|||Week 0 to Week 64|
1628035|NCT02163577|2990282|Superiority|||||||0.465|||||||one sample t-test|||Week 0 to Week 40|
1628036|NCT02163577|2990282|Superiority|||||||0.0088|||||||one sample t-test|||Week 0 to Week 40|
1628037|NCT02163577|2990283|Superiority||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628038|NCT02163577|2990283|Superiority||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628039|NCT02163577|2990283|Superiority||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628040|NCT02163577|2990283|Superiority||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628041|NCT02163577|2990283|Superiority||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40|
1628042|NCT02163577|2990283|Superiority||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40|
1628043|NCT02163577|2990284|Superiority||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628044|NCT02163577|2990284|Superiority||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628045|NCT02163577|2990284|Superiority||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628201|NCT02161406|2990471|Superiority|||||||0.28|||||||Mixed Models Analysis||||
1628046|NCT02163577|2990284|Superiority||||||<|0.0001||||||GEE model includes RGI-C as the dependent variable, visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628047|NCT02163577|2990284|Superiority||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40|
1628048|NCT02163577|2990284|Superiority||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40|
1628049|NCT02163577|2990285|Superiority||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628050|NCT02163577|2990285|Superiority||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628051|NCT02163577|2990285|Superiority||Difference in LS Means|-0.02|||<||2-Sided|95.0|-0.34|0.29||||||Difference in change to Week 64|
1628052|NCT02163577|2990285|Superiority||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628053|NCT02163577|2990285|Superiority||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628054|NCT02163577|2990285|Superiority||Difference in LS Means|0.21|||<||2-Sided|95.0|-0.12|0.54||||||Difference in change to Week 40|
1628055|NCT02163577|2990285|Superiority||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40|
1628056|NCT02163577|2990285|Superiority||||||<|0.0001||||||ANCOVA model includes RGI-C as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40|
1628057|NCT02163577|2990286|Superiority||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628058|NCT02163577|2990286|Superiority||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628059|NCT02163577|2990286|Superiority||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628060|NCT02163577|2990286|Superiority||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628061|NCT02163577|2990286|Superiority||||||<|0.0015||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40|
1628062|NCT02163577|2990286|Superiority||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40|
1628063|NCT02163577|2990287|Superiority||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628064|NCT02163577|2990287|Superiority||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628065|NCT02163577|2990287|Superiority||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628066|NCT02163577|2990287|Superiority||||||<|0.0001||||||GEE model includes the change from baseline in RSS as the dependent variable, visit, regimen, visit by regimen as factors, and RSS at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628067|NCT02163577|2990287|Superiority||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40|
1628068|NCT02163577|2990287|Superiority||||||<|0.0001||||||ANCOVA model includes the change from baseline in RSS as the dependent variable, regimen group as factor, and RSS at baseline as covariate.|ANCOVA|||Week 40|
1628069|NCT02163577|2990288|Superiority||||||<|0.0001|||||||one sample t test|||Week 160|
1628070|NCT02163577|2990288|Superiority||||||<|0.0001|||||||one sample t test|||Week 160|
1628071|NCT02163577|2990288|Superiority||||||<|0.0001|||||||one sample t test|||Week 64|
1628072|NCT02163577|2990288|Superiority||||||<|0.0001|||||||one sample t test|||Week 64|
1628073|NCT02163577|2990288|Superiority||||||<|0.0001|||||||one sample t test|||Week 40|
1628074|NCT02163577|2990288|Superiority||||||<|0.0001|||||||one sample t test|||Week 40|
1628075|NCT02163577|2990289|Superiority|||||||0.0002|||||||one sample t test|||Week 160|
1628076|NCT02163577|2990289|Superiority|||||||0.0018|||||||one sample t test|||Week 160|
1628077|NCT02163577|2990289|Superiority|||||||0.0024|||||||one sample t test|||Week 64|
1628078|NCT02163577|2990289|Superiority||||||<|0.0001|||||||one sample t test|||Week 64|
1628079|NCT02163577|2990289|Superiority||||||<|0.0001|||||||one sample t test|||Week 40|
1628080|NCT02163577|2990289|Superiority||||||<|0.0001|||||||one sample t test|||Week 40|
1628081|NCT02163577|2990290|Superiority||||||<|0.0001|||||||one sample t test|||Week 160|
1628082|NCT02163577|2990290|Superiority||||||<|0.0001|||||||one sample t test|||Week 160|
1628083|NCT02163577|2990290|Superiority||||||<|0.0001|||||||one sample t test|||Week 64|
1628084|NCT02163577|2990290|Superiority||||||<|0.0001|||||||one sample t test|||Week 64|
1628085|NCT02163577|2990290|Superiority||||||<|0.0001|||||||one sample t test|||Week 40|
1628087|NCT02163577|2990291|Superiority||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628088|NCT02163577|2990291|Superiority||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 160|
1628089|NCT02163577|2990291|Superiority||Difference in LS Means|-0.16|||<||2-Sided|95.0|-0.45|0.13||||||Difference in change to Week 64|
1628090|NCT02163577|2990291|Superiority||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628091|NCT02163577|2990291|Superiority||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 64|
1628092|NCT02163577|2990291|Superiority||Difference in LS Means|-0.33|||<||2-Sided|95.0|-0.63|-0.04||||||Difference in change to Week 40|
1628093|NCT02163577|2990291|Superiority||||||<|0.0001||||||Per GEE model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1628094|NCT02163577|2990291|Superiority||||||<|0.0001||||||Per generalized estimating equations (GEE) model, which included visit, regimen, visit by regimen as factors, and RSS total score at baseline as a covariate, with exchangeable covariance structure.|GEE model|||Week 40|
1628095|NCT02163538|2990292|Superiority|||||||0.0821|||||||Wilcoxon (Mann-Whitney)||||
1628096|NCT02163538|2990293|Superiority|||||||0.0281|||||||Wilcoxon (Mann-Whitney)||||
1628097|NCT02163538|2990294|Superiority|||||||0.0031|||||||Chi-squared||||
1628098|NCT02163538|2990295|Superiority|||||||0.582|||||||Chi-squared||||
1628099|NCT02163538|2990296|Superiority|||||||1|||||||Chi-squared||||
1628100|NCT02163538|2990297|Superiority|||||||0.0001|||||||Wilcoxon (Mann-Whitney)||||
1628101|NCT02162862|2990331|Other||||||<|0.005|||||||t-test, 2 sided||||
1628102|NCT02162862|2990331|Other||||||<|0.646|||||||t-test, 2 sided||||
1628103|NCT02162862|2990331|Other||||||<|0.005|||||||t-test, 2 sided||||
1628104|NCT02162862|2990332|Other|||||||0.102|||||||t-test, 2 sided||||
1628105|NCT02162862|2990332|Other||||||<|0.005|||||||t-test, 2 sided||||
1628106|NCT02162862|2990332|Other||||||<|0.005|||||||t-test, 2 sided||||
1628107|NCT02162771|2990334|Non-Inferiority|Non-inferiority margin of -7% was predefined.|Point estimate difference|4.3|||||2-Sided||||||||||
1628108|NCT02162771|2990335|Equivalence|The 90% CIs of the ratios of geometric means of log-transformed transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)|Ratio of geometric least square means|100.67|||||2-Sided|90.0|93.84|108.0||||||Equivalence in Cmax,ss between CT-P10 and Rituxan|
1628109|NCT02162771|2990336|Equivalence|The 90% CIs of the ratios of geometric means of log-transformed values were used to assess the bioequivalence between CT-P10 and Rituxan (bioequivalence range of 80% to 125%)|Ratio of geometric least square means|102.25|||||2-Sided|90.0|94.05|111.17||||||Equivalence in AUCtau between CT-P10 and Rituxan|
1628110|NCT02162446|2990360|Other|||||||0.219|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628111|NCT02162446|2990360|Other|||||||0.375|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628112|NCT02162446|2990360|Other|||||||0.039|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628113|NCT02162446|2990360|Other|||||||0.91|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628114|NCT02162446|2990361|Other|||||||0.469|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628115|NCT02162446|2990361|Other|||||||0.297|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.|
1628116|NCT02162446|2990361|Other|||||||0.813|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628117|NCT02162446|2990361|Other|||||||0.813|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in lymph node with RT as lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.|
1628118|NCT02162446|2990361|Other|||||||0.098|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628119|NCT02162446|2990361|Other|||||||0.426|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.|
1628120|NCT02162446|2990361|Other|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628202|NCT02160990|2990486|Superiority or Other|||||||0.23|||||||ANCOVA||||
1628121|NCT02162446|2990361|Other|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of 3D-SUV-R of malignant lesions in liver with RT as liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.|
1628122|NCT02162446|2990362|Other|||||||0.375|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628123|NCT02162446|2990362|Other|||||||0.233|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628124|NCT02162446|2990362|Other|||||||0.47|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628125|NCT02162446|2990363|Other|||||||1|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628126|NCT02162446|2990363|Other|||||||0.297|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.|
1628127|NCT02162446|2990363|Other|||||||0|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628128|NCT02162446|2990363|Other|||||||0.001|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.|
1628129|NCT02162446|2990363|Other|||||||0.339|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628130|NCT02162446|2990363|Other|||||||0.064|||||||Wilcoxon signed rank test|||Comparison of SUVmax of RT in muscle between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.|
1628131|NCT02162446|2990364|Other|||||||0.219|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628132|NCT02162446|2990364|Other|||||||0.027|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628133|NCT02162446|2990365|Other|||||||0.578|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628134|NCT02162446|2990365|Other|||||||0.688|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.|
1628135|NCT02162446|2990365|Other|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628136|NCT02162446|2990365|Other|||||||0.25|||||||Wilcoxon signed rank test|||Comparison of SUVmax of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.|
1628137|NCT02162446|2990367|Other|||||||1|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628138|NCT02162446|2990367|Other|||||||0.5|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in lymph node between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.|
1628139|NCT02162446|2990367|Other|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628140|NCT02162446|2990367|Other|||||||0.012|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in liver between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.|
1628141|NCT02162446|2990367|Other|||||||0.004|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 2 receptor scan (ITT population Day 21) at 1 hour time point.|
1628142|NCT02162446|2990367|Other|||||||0.016|||||||Wilcoxon signed rank test|||Comparison of malignant lesions in total tissues between previous somatostatin receptor scan (ITT population pre-dose) and the 68Ga-OPS202 visit 1 receptor scan (ITT population Day 0) at 1 hour time point.|
1628143|NCT02161757|2990384|Superiority||Odds Ratio (OR)|0.88||||0.421|2-Sided|95.0|0.65|1.19|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q4W vs placebo.|
1628144|NCT02161757|2990384|Superiority||Odds Ratio (OR)|0.95||||0.732|2-Sided|95.0|0.71|1.28|||Cochran-Mantel-Haenszel||The estimate of each odds ratio was obtained from two separate models, from a Cochran-Mantel-Haenszel test controlling for geographical region, age group and periostin group at baseline.|Comparison of number of patients with ≥ 1 asthma exacerbations up to Week 52: Tralo 300 mg Q2W vs placebo.|
1628203|NCT02160990|2990487|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1628204|NCT02160990|2990488|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1628145|NCT02161757|2990385|Superiority||LS Mean difference|-2.36|||||2-Sided|95.0|-5.84|1.12|||||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."|
1628146|NCT02161757|2990385|Superiority||LS Mean difference|-1.8|||||2-Sided|95.0|-5.29|1.69|||||Fixed categorical effects of baseline number (%) of awakenings, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in number (%) of awakenings at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."|
1628147|NCT02161757|2990386|Superiority||LS Mean difference|0.61|||||2-Sided|95.0|-9.13|10.35|||||Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."|
1628148|NCT02161757|2990386|Superiority||LS Mean difference|7.14|||||2-Sided|95.0|-2.6|16.87|||||Fixed categorical effects of baseline PEF (evening), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in evening PEF at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."|
1628149|NCT02161757|2990386|Superiority||LS Mean difference|1.77|||||2-Sided|95.0|-7.99|11.53|||||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."|
1628150|NCT02161757|2990386|Superiority||LS Mean difference|6.25|||||2-Sided|95.0|-3.53|16.03|||||Fixed categorical effects of baseline PEF (morning), treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in morning PEF at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."|
1628151|NCT02161757|2990387|Superiority||LS Mean difference|-0.16|||||2-Sided|95.0|-0.56|0.24|||||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q4W vs placebo. REML based repeated measures analysis.|
1628152|NCT02161757|2990387|Superiority||LS Mean difference|-0.11|||||2-Sided|95.0|-0.51|0.29|||||Fixed categorical effects of baseline rescue medication use, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|Comparison of mean change from baseline in rescue medication use at Week 52: Tralo 300 mg Q2W vs placebo. REML based repeated measures analysis.|
1628153|NCT02161757|2990389|Superiority||Rate ratio|0.78||||0.3603|2-Sided|95.0|0.46|1.33|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q4W vs placebo.|
1628154|NCT02161757|2990389|Superiority||Rate ratio|0.54||||0.0369|2-Sided|95.0|0.3|0.96|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations resulting in hospitalisation or ER treatment (yes/no) in the year before the study.|Comparison of AAER associated with an ER/UC visit or hospitalisation: Tralo 300 mg Q2W vs placebo.|
1628155|NCT02161757|2990390|Superiority||LS Mean difference|-0.12|||||2-Sided|95.0|-0.26|0.01|||||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."|
1628156|NCT02161757|2990390|Superiority||LS Mean difference|-0.16|||||2-Sided|95.0|-0.29|-0.02|||||Fixed categorical effects of baseline ACQ-6 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for ACQ-6 at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."|
1628157|NCT02161757|2990391|Superiority||LS Mean difference|0.12|||||2-Sided|95.0|-0.03|0.28|||||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."|
1628158|NCT02161757|2990391|Superiority||LS Mean difference|0.15|||||2-Sided|95.0|-0.01|0.31|||||Fixed categorical effects of baseline AQLQ(S)+12 score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of change in mean score from baseline for AQLQ(S)+12 at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."|
1628159|NCT02161757|2990392|Superiority||LS Mean difference|-0.02|||||2-Sided|95.0|-0.15|0.12|||||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis."|
1628205|NCT02160977|2990489|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1628206|NCT02160977|2990490|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1628207|NCT02160977|2990491|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1628160|NCT02161757|2990392|Superiority||LS Mean difference|-0.09|||||2-Sided|95.0|-0.23|0.04|||||Fixed categorical effects of baseline asthma symptom score, treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of mean change from baseline in total asthma symptom score at Week 52: Tralo 300 mg Q2W vs placebo.~REML based repeated measures analysis."|
1628161|NCT02161757|2990393|Superiority||LS Mean difference|2.1|||||2-Sided|95.0|-1.58|5.77|||||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q4W vs placebo.~REML based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment."|
1628162|NCT02161757|2990393|Superiority||Least square (LS) Mean difference|6.03|||||2-Sided|95.0|2.34|9.73|||||Fixed categorical effects of treatment group, geographical region, age group, periostin group, visit and treatment-by-visit interaction and number of asthma exacerbations in year before study as a fixed covariate.|"Comparison of percent change from baseline in pre-dose/pre-BD FEV1 at Week 52: Tralo 300 mg Q2W vs placebo.~Restricted maximum likelihood (REML) based repeated measures analysis performed on patients with a baseline pre-dose/pre-BD FEV1 assessment."|
1628163|NCT02161757|2990394|Superiority|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|9.76||||0.4406|2-Sided|95.0|-17.16|30.5|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): Tralo 300 mg Q4W vs placebo.|
1628164|NCT02161757|2990394|Superiority|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate reduction|7.01||||0.5859|2-Sided|95.0|-20.76|28.39|||Negative binominal||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate reduction): Tralo 300 mg Q2W vs placebo.|
1628165|NCT02161757|2990394|Superiority|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.9||||0.4406|2-Sided|95.0|0.7|1.17|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): Tralo 300 mg Q4W vs placebo.|
1628166|NCT02161757|2990394|Superiority|The null hypothesis was that the exacerbation rate during the 52-week double-blind treatment period on tralokinumab was equal to the corresponding exacerbation rate on placebo.|Rate ratio|0.93||||0.5859|2-Sided|95.0|0.72|1.21|||Negative binomial||Covariates in the model included treatment group, geographical region, age group, periostin group at baseline and number of exacerbations in the year before the study.|Comparison of AAER (rate ratio): Tralo 300 mg Q2W vs placebo.|
1628167|NCT02161575|2990417|Superiority||Median Difference (Final Values)|-30.75|||<|0.0001|2-Sided|95.0|-59.5|-20.5|||Wilcoxon (Mann-Whitney)|Confidence Interval for the Median Change form Baseline||The null hypothesis was that the change in CSRT from baseline to Day 90 was zero|
1628168|NCT02161406|2990438|Superiority|||||||0.2906|||||||Mixed Models Analysis||||
1628169|NCT02161406|2990439|Superiority|||||||0.1679|||||||Mixed Models Analysis||||
1628170|NCT02161406|2990440|Superiority|||||||0.7281|||||||Mixed Models Analysis||||
1628171|NCT02161406|2990441|Superiority|||||||0.1604|||||||Mixed Models Analysis||||
1628172|NCT02161406|2990442|Superiority|||||||0.4927|||||||Mixed Models Analysis||||
1628173|NCT02161406|2990443|Superiority|||||||0.0751|||||||Mixed Models Analysis||||
1628174|NCT02161406|2990444|Superiority|||||||0.0097|||||||Mixed Models Analysis||||
1628175|NCT02161406|2990445|Superiority|||||||0.0193|||||||Mixed Models Analysis||||
1628176|NCT02161406|2990446|Superiority|||||||0.5831|||||||Mixed Models Analysis||||
1628177|NCT02161406|2990447|Superiority|||||||0.9075|||||||Mixed Models Analysis||||
1628178|NCT02161406|2990448|Superiority|||||||0.1769|||||||Mixed Models Analysis||||
1628179|NCT02161406|2990449|Superiority|||||||0.03|||||||van Elteren test|The van Elteren test adjusted for duration of dcSSc. Multiple imputation was used to address missing follow-up data in 5 components of CRISS.|||
1628180|NCT02161406|2990450|Superiority|||||||0.07|||||||Mixed Models Analysis||||
1628181|NCT02161406|2990451|Superiority|||||||0.24|||||||Mixed Models Analysis||||
1628182|NCT02161406|2990452|Superiority|||||||0.92|||||||Mixed Models Analysis||||
1628183|NCT02161406|2990453|Superiority|||||||0.13|||||||Mixed Models Analysis||||
1628184|NCT02161406|2990454|Superiority|||||||0.91|||||||Mixed Models Analysis||||
1628185|NCT02161406|2990455|Superiority|||||||0.86|||||||Mixed Models Analysis||||
1628186|NCT02161406|2990456|Superiority|||||||0.81|||||||Mixed Models Analysis||||
1628187|NCT02161406|2990457|Superiority|||||||0.21|||||||Mixed Models Analysis||||
1628188|NCT02161406|2990458|Superiority|||||||0.15|||||||Mixed Models Analysis||||
1628189|NCT02161406|2990459|Superiority|||||||0.55|||||||Mixed Models Analysis||||
1628190|NCT02161406|2990460|Superiority|||||||0.37|||||||Mixed Models Analysis||||
1628191|NCT02161406|2990461|Superiority|||||||0.82|||||||Mixed Models Analysis||||
1628192|NCT02161406|2990462|Superiority|||||||0.12|||||||Mixed Models Analysis||||
1628193|NCT02161406|2990463|Superiority|||||||0.25|||||||Mixed Models Analysis||||
1628194|NCT02161406|2990464|Superiority|||||||0.34|||||||Mixed Models Analysis||||
1628195|NCT02161406|2990465|Superiority|||||||0.19|||||||Mixed Models Analysis||||
1628196|NCT02161406|2990466|Superiority|||||||0.005|||||||Mixed Models Analysis||||
1628197|NCT02161406|2990467|Superiority|||||||0.19|||||||Mixed Models Analysis||||
1628198|NCT02161406|2990468|Superiority|||||||0.11|||||||Mixed Models Analysis||||
1628211|NCT02160626|2990503|Other|For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.||||||0.0004||||||For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.|Cochran-Mantel-Haenszel||||
1628212|NCT02160626|2990503|Other|||||||0.0016||||||For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|For all analyses, two-tail alpha will be set to 0.05 with no adjustment for multiple comparisons.||"Secondary efficacy analyses will also be conducted based on the proportion of subjects who have at least 3 of 4 target lesions judged to be clear on the PLA (PLA=0) at Visit 8.~A separate comparison will be made between each active treatment group and the vehicle treatment group using Cochran-Mantel-Haenszel (CMH) tests stratified by site."|
1628213|NCT02160626|2990504|Other|||||||0.0001|||||||ANCOVA|||mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.|
1628214|NCT02160626|2990504|Other|||||||0.0001|||||||ANCOVA|||mean change from baseline to Visit 8 PLA will be performed using Analysis of Covariance (ANCOVA) with baseline PLA as the covariate.|
1628215|NCT02160626|2990505|Other|||||||0.0001|||||||ANOVA||||
1628216|NCT02160626|2990505|Other|||||||0.0003|||||||ANOVA||||
1628217|NCT02160145|2990523|Other||Treatment difference|1.011|||<|0.0001|2-Sided|95.0|0.618|1.403||A two-sided alpha of 0.05 was applied when the primary endpoint reached a two-sided alpha of 0.05.|Mixed Models Analysis|||Difference in treatment effect was derived from a linear mixed model with effects of treatment, time, treatment ime interaction, acute haemodynamic effect, pretreatment baseline, and randomization stratification factors. An unstructured variance matrix was assumed for the random intercept and time.|
1628218|NCT02160145|2990524|Other||Treatment difference|1.271|||<|0.0001|2-Sided|95.0|0.859|1.684||A 2-sided alpha of 0.05 was applied to the primary analysis of the primary endpoint.|ANCOVA|Weighted Analysis of Covariance (ANCOVA) with effects of treatment and randomization stratification factors and covariate baseline.||Tolvaptan versus placebo. Treatment difference in the change of eGFR assessed the efficacy of tolvaptan treatment as compared with placebo in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period.|
1628219|NCT02159352|2990616|Superiority or Other||Adjusted Geometric Mean Ratio|1.154|||||2-Sided|90.0|1.07|1.244||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed (AUC(TAU)/D).|
1628220|NCT02159352|2990616|Superiority or Other||Adjusted Geometric Mean Ratio|1.406|||||2-Sided|90.0|1.317|1.501||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed (AUC(TAU)/D).|
1628221|NCT02159352|2990617|Superiority or Other||Adjusted Geometric Mean Ratio|0.673|||||2-Sided|90.0|0.611|0.742||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax/D.|
1628222|NCT02159352|2990617|Superiority or Other||Adjusted Geometric Mean Ratio|0.768|||||2-Sided|90.0|0.697|0.846||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax/D.|
1628223|NCT02159352|2990620|Superiority or Other||Adjusted Geometric Mean Ratio|0.577|||||2-Sided|90.0|0.535|0.622||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed AUC(TAU).|
1628224|NCT02159352|2990620|Superiority or Other||Adjusted Geometric Mean Ratio|0.703|||||2-Sided|90.0|0.658|0.75||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed AUC(TAU).|
1628225|NCT02159352|2990621|Superiority or Other||Adjusted Geometric Mean Ratio|0.337|||||2-Sided|90.0|0.306|0.371||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax.|
1628226|NCT02159352|2990621|Superiority or Other||Adjusted Geometric Mean Ratio|0.384|||||2-Sided|90.0|0.348|0.423||||||A general linear mixed effect model (restricted maximum likelihood) with treatment as fixed effect and measurements within each participant as repeated measures was fitted to the log-transformed Cmax.|
1628227|NCT02159118|2990632|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1628228|NCT02159118|2990633|Superiority or Other|||||||0.51|||||||Wilcoxon (Mann-Whitney)||||
1628229|NCT02159118|2990634|Superiority or Other|||||||0.22|||||||Wilcoxon (Mann-Whitney)||||
1628230|NCT02159118|2990635|Superiority or Other|||||||0.93|||||||Wilcoxon (Mann-Whitney)||||
1628231|NCT02159118|2990636|Superiority or Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)||||
1628232|NCT02159118|2990637|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1628233|NCT02159118|2990638|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1628234|NCT02159118|2990639|Superiority or Other|||||||0.65|||||||Wilcoxon (Mann-Whitney)||||
1628235|NCT02159118|2990640|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1628236|NCT02158936|2990673|Superiority or Other||Geometric mean ratio|1.39|||||2-Sided|90.0|0.97|1.99|||||||
1628237|NCT02158936|2990674|Superiority or Other||Geometric mean ratio|1.31|||||2-Sided|90.0|0.99|1.74|||||||
1628238|NCT02158936|2990691|Superiority or Other||Hazard Ratio (HR)|1.42||||0.164|2-Sided|95.0|0.97|2.08|||Log Rank|||Confidence Intervals estimated using the Brookmeyer-Crowley method. Hazard ratios are estimated using the Pike estimator. A hazard ratio <1 indicates a lower risk with eltrombopag compared with Placebo. Log-rank test stratified by IVRS stratification factors|
1628239|NCT02158936|2990692|Superiority or Other||Odds Ratio (OR)|0.37||||1|2-Sided|95.0|0.21|0.65||One sided p value|Cochran-Mantel-Haenszel|Stratified by Interactive Voice Response System (IVRS) stratification factors|||
1628240|NCT02158806|2990723|Superiority||Incidence Rate Ratio|1.1||||0.71|2-Sided|95.0|0.7|1.7|||IRR test statistic|Incidence Rate Ratio (IRR) test statistic compared to probability of the same obtained from standard normal distribution tables.|||
1628241|NCT02158806|2990724|Superiority||Risk Ratio (RR)|1.01||||0.917|2-Sided|95.0|0.87|1.17|||Chi-squared||||
1628242|NCT02158806|2990725|Superiority||Mean Difference (Net)|-1.9||||0.273|2-Sided|95.0|-5.2|1.5|||Regression, Linear|Adjusted for baseline values|||
1628243|NCT02158806|2990725|Superiority||Mean Difference (Net)|-3.0||||0.257|2-Sided|95.0|-8.1|2.2|||Regression, Linear|Adjusted for baseline values||Change in emotional status|
1628244|NCT02158806|2990725|Superiority||Mean Difference (Net)|-1.3||||0.568|2-Sided|95.0|-5.6|3.1|||Regression, Linear|Adjusted for baseline values||Change in cosmesis|
1628245|NCT02158806|2990725|Superiority||Mean Difference (Net)|-1.3||||0.408|2-Sided|95.0|-4.5|1.9|||Regression, Linear|Adjusted for baseline values||Change in domestic activities|
1628246|NCT02158806|2990725|Superiority||Mean Difference (Net)|-1.5||||0.438|2-Sided|95.0|-5.2|2.2|||Regression, Linear|Adjusted for baseline values||Change in social function|
1628247|NCT02158806|2990726|Superiority||Mean Difference (Net)|3.4||||0.156|2-Sided|95.0|-1.3|8.0||Adjusted for baseline values|Regression, Linear||||
1628248|NCT02158806|2990727|Superiority||Mean Difference (Net)|-2.3||||0.236|2-Sided|95.0|-6.2|1.5|||Regression, Linear|Adjusted for baseline values||Change in Mental Health|
1628249|NCT02158806|2990727|Superiority||Mean Difference (Net)|3.7||||0.4|2-Sided|95.0|-4.9|12.3|||Regression, Linear|Adjusted for baseline values||Change in Role Emotional|
1628250|NCT02158806|2990727|Superiority||Mean Difference (Net)|1.0||||0.756|2-Sided|95.0|-5.1|7.0|||Regression, Linear|Adjusted for baseline values||Change in Social Functioning|
1628251|NCT02158806|2990727|Superiority||Mean Difference (Net)|4.2||||0.057|2-Sided|95.0|-0.1|8.5|||Regression, Linear|Adjusted for baseline values||Change in Vitality|
1628252|NCT02158806|2990727|Superiority||Mean Difference (Net)|-0.3||||0.873|2-Sided|95.0|-4.3|3.6|||Regression, Linear|Adjusted for baseline values||Change in General Health|
1628253|NCT02158806|2990727|Superiority||Mean Difference (Net)|2.3||||0.449|2-Sided|95.0|-3.7|8.4|||Regression, Linear|Adjusted for baseline values||Change in Bodily Pain|
1628254|NCT02158806|2990727|Superiority||Mean Difference (Net)|1.4||||0.768|2-Sided|95.0|-8.0|10.8|||Regression, Linear|Adjusted for baseline values||Change in Role Physical|
1628255|NCT02158806|2990727|Superiority||Mean Difference (Net)|1.1||||0.714|2-Sided|95.0|-5.0|7.2|||Regression, Linear|Adjusted for baseline values||Change in Physical Functioning|
1628256|NCT02158806|2990728|Superiority||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.6||0.25|2-Sided|95.0|-1.9|0.5||Adjusted for baseline values.|ANCOVA|One participant in aspirin group had missing data for 24 week endpoint visit; we used the baseline value for imputation.|Placebo group = reference group.||
1628257|NCT02158806|2990729|Superiority|Participants analysed in the groups to which they were randomised (intention to treat analysis).|Risk Ratio (RR)|0.88||||0.073|2-Sided|95.0|0.76|1.01|||Chi-squared||||
1628258|NCT02158806|2990730|Superiority|Participants analysed in the groups to which they were randomised (intention to treat analysis).|Cox Proportional Hazard|0.85|Standard Error of the Mean|0.146||0.246|2-Sided|95.0|0.64|1.13|||Log Rank||Placebo group = reference group|Placebo group = reference group|
1628259|NCT02158546|2990745|Superiority||Least square means difference|-0.3|Standard Error of the Mean|0.95||0.782|2-Sided|95.0|-2.1|1.6|||Mixed Models Analysis||||
1628260|NCT02158533|2990749|Superiority||Least squares mean difference|0.0|Standard Error of the Mean|1.17||0.975|2-Sided|95.0|-2.3|2.3||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 0.5mg/0.5mg was compared to placebo (i.e., ALKS 5461 0.5mg/0.5mg S1 vs Placebo S1; and ALKS 5461 0.5mg/0.5mg S2 vs Placebo S2). The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5/0.5 compared to placebo.|
1628261|NCT02158533|2990749|Superiority||Least squares mean difference|-1.8|Standard Error of the Mean|1.14||0.109|2-Sided|95.0|-4.1|0.4||Hypothesis tests were two-sided with an alpha of 0.05. Control of type 1 error inflation due to multiplicity was achieved by pre-specifying a fixed sequence for statistical tests.|Mixed Models Analysis|ALKS 5461 was compared to pbo using stage-specific MMRM for MADRS-10 Change from Baseline. Model-derived estimates were combined using equal weights.|Estimates below zero favor ALKS 5461.|Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified equal weights. Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2. The pre-specified order of hypothesis tests was ALKS 5461 2/2 compared to placebo followed by ALKS 5461 0.5mg/0.5mg compared to placebo.|
1628262|NCT02158494|2990767|Superiority|||||||0.99|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 26 weeks|
1628263|NCT02158494|2990767|Superiority|||||||0.47|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 14 weeks|
1628264|NCT02158494|2990767|Superiority|||||||0.41|||||||t-test, 2 sided|||P-Value for Sensory Organization Test results at 2 weeks|
1628265|NCT02157948|2990795|Non-Inferiority or Equivalence|Equivalence Testing: The lower and upper bounds of the same 2-sided 95% CI of the between-group difference were compared with the equivalence margin of ±1.44% for assessing equivalence.|Difference from CP2|-0.07|||<|0.001|2-Sided|95.0|-0.72|0.57||Two-sided p-value based on the prespecified equivalence margin of ±1.44% for lumbar spine.|ANCOVA|||The treatment comparison was analyzed using the analysis of covariance (ANCOVA) model including treatment, baseline BMD value, machine type, and machine type-by-baseline BMD value interaction. The effect of denosumab CP4 on lumbar spine BMD at 12 months relative to the effect of denosumab CP2 was estimated by the least-squares mean of the treatment difference (denosumab CP4 – denosumab CP2) and the corresponding 2-sided 95% confidence interval (CI).|
1628285|NCT02157779|2990823|Superiority|||||||0.012||||||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score||Population Description: All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.|
1628899|NCT02145156|2992165|Superiority or Other|||||||0.18|||||||Fisher Exact||||
1628266|NCT02157948|2990795|Non-Inferiority or Equivalence|Non-inferiority Testing: The lower bound of the 2-sided 95% CI of the between-group difference (denosumab CP4 – denosumab CP2) in percent change from baseline in lumbar spine BMD at 12 months was compared with the non-inferiority margin of -1.44% for assessing non-inferiority.|Difference from CP2|-0.07|||<|0.001|2-Sided|95.0|-0.72|0.57||One-sided p-value based on the prespecified non-inferiority margin of -1.44% for lumbar spine.|ANCOVA|||The treatment comparison was analyzed using the analysis of covariance (ANCOVA) model including treatment, baseline BMD value, machine type, and machine type-by-baseline BMD value interaction. The effect of denosumab CP4 on lumbar spine BMD at 12 months relative to the effect of denosumab CP2 was estimated by the least-squares mean of the treatment difference (denosumab CP4 – denosumab CP2) and the corresponding 2-sided 95% confidence interval (CI).|
1628267|NCT02157935|2990796|Superiority or Other||Mean Difference (Final Values)|-0.028||||0.0048|2-Sided|95.0|-0.048|-0.009|||ANCOVA||||
1628268|NCT02157935|2990797|Superiority or Other||Mean Difference (Final Values)|-0.203||||0.0082|2-Sided|95.0|-0.353|-0.053|||ANCOVA||||
1628269|NCT02157935|2990798|Superiority or Other||Mean Difference (Final Values)|0.03||||0.0091|2-Sided|95.0|0.008|0.053|||Mixed Models Analysis||||
1628270|NCT02157935|2990799|Superiority or Other||Mean Difference (Final Values)|-1.343||||0.007|2-Sided|95.0|-2.318|-0.368|||Mixed Models Analysis||||
1628271|NCT02157935|2990800|Superiority or Other||Hazard Ratio (HR)|0.78||||0.0164|2-Sided|95.0|0.64|0.96|||Regression, Cox||||
1628272|NCT02157935|2990801|Superiority or Other||Rate ratio|0.76||||0.0059|2-Sided|95.0|0.62|0.92|||Negative binomial model||||
1628273|NCT02157883|2990803|Superiority or Other (legacy)||Geometric mean ratio|49.02|||||2-Sided|90.0|43.7|54.99|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.|
1628274|NCT02157883|2990804|Superiority or Other (legacy)||Geometric mean ratio|44.33|||||2-Sided|90.0|39.94|49.21|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.|
1628275|NCT02157883|2990805|Superiority or Other (legacy)||Geometric mean ratio|108.25|||||2-Sided|90.0|94.36|124.19|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.|
1628276|NCT02157883|2990806|Superiority or Other (legacy)||Geometric mean ratio|75.87|||||2-Sided|90.0|64.18|89.69|||||AZD9291+itraconazole / AZD9291 alone. No pre-specified margins for equivalence test for metabolites, but analysed for consistency with AZD9291 analysis.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.|
1628277|NCT02157883|2990813|Non-Inferiority or Equivalence (legacy)|Upper bound of the 90% CIs below 200%.|Geometric mean ratio|124.17|||||2-Sided|90.0|114.61|134.53|||||AZD9291+itraconazole / AZD9291 alone. Results based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.|
1628278|NCT02157883|2990814|Non-Inferiority or Equivalence (legacy)|Upper bound of the 90% CIs below 200%.|Geometric mean ratio|79.87|||||2-Sided|90.0|73.15|87.21|||||AZD9291+itraconazole / AZD9291 alone. Results based on linear mixed-effects model with treatment as fixed effect and patient as a random effect.|Study sized so experiment-wise power for the upper bound of the 90% CIs of geometric mean ratios for both AUC and Cmax of AZD9291 being below 200% was 90% (95% for each parameter). Within patient CV assumed to be 34%. A 50% increase in exposure was also assumed.|
1628279|NCT02157779|2990815|Superiority|||||||0.024||||||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score||"All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.~Data was also winsorized and log10 transformed to counter high levels of skewness."|
1628280|NCT02157779|2990817|Superiority|||||||0.034||||||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score||"All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.~Data was also winsorized and log10 transformed to counter high levels of skewness."|
1628281|NCT02157779|2990819|Superiority|||||||0.416||||||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score||All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.|
1628282|NCT02157779|2990820|Superiority|||||||0.0247||||||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score||All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.|
1628283|NCT02157779|2990821|Superiority|||||||0.064||||||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score||All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.|
1628284|NCT02157779|2990822|Superiority|||||||0.165||||||Threshold for statistical significance was 0.025.|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score||All randomized participants with at least one post-baseline assessment were used in the statistical analysis process.|
1628526|NCT02152371|2991378|Superiority or Other (legacy)||Odds Ratio (OR)|6.66|||<|0.001|2-Sided|95.0|3.7|12.0|||Regression, Logistic||||
1628286|NCT02157779|2990824|Superiority|||||||0.182||||||The threshold for statistical significance was p=0.025|ANCOVA|Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score||Population Description: All randomized participants with at least one post-baseline assessment were used in the statistical analysis process. Data was winsorized and log10 transformed to counter high levels of skewness.|
1628287|NCT02157779|2990825|Superiority|||||||0.0199||||||Threshold for statistical significance was 0.025.|ANCOVA|Method used: Hierarchical Linear Model (HLM) Repeated Measures Analysis of Covariance, Controlling for Baseline Score|||
1628288|NCT02157519|2990829|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.1||0.64|2-Sided|95.0|-0.24|0.15||threshold p < 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of hospitalizations over they study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment|
1628289|NCT02157519|2990830|Superiority||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.06||0.682|2-Sided|95.0|-0.15|0.1||threshold p < 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of emergency department (ED) visits over the study period between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.|
1628290|NCT02157519|2990831|Superiority||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.17||0.97|2-Sided|95.0|-0.34|0.35||threshold p < 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with trust in clinicians (FACIT-TS-PS Trust in Clinicians) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.|
1628291|NCT02157519|2990831|Superiority||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.28||0.481|2-Sided|95.0|-0.35|0.75||threshold p < 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with nursing care (FACIT-TS-PS Nursing Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.|
1628292|NCT02157519|2990831|Superiority||Mean Difference (Final Values)|-0.97|Standard Error of the Mean|0.72||0.178|2-Sided|95.0|-2.39|0.45||threshold p < 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing change in treatment satisfaction with comprehensive care (FACIT-TS-PS Comprehensive Care) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.|
1628293|NCT02157519|2990831|Superiority||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.18||0.057|2-Sided|95.0|-0.72|0.01||threshold p < 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post assessment||Analysis comparing change in satisfaction with interpersonal treatment (FACIT-TS-PS Interpersonal Treatment) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.|
1628294|NCT02157519|2990831|Superiority||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.28||0.17|2-Sided|95.0|-0.93|0.17||threshold p < 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post assessment||Analysis comparing change in treatment satisfaction with clinician explanations (FACIT-TS-PS-Clinician Explanations) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.|
1628295|NCT02157519|2990832|Superiority||Mean Difference (Final Values)|-0.75|Standard Error of the Mean|0.6||0.216|2-Sided|95.0|-1.94|0.44||threshold p <0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in functional QOL (FACT-Functional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.|
1628296|NCT02157519|2990832|Superiority||Mean Difference (Final Values)|0.49|Standard Error of the Mean|0.58||0.392|2-Sided|95.0|-0.64|1.63||threshold p <0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in emotional QOL (FACT-Emotional Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.|
1628297|NCT02157519|2990832|Superiority||Mean Difference (Final Values)|-1.67|Standard Error of the Mean|0.74||0.025|2-Sided|95.0|-3.12|-0.21||threshold p <0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in social QOL (FACT-Social Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.|
1628298|NCT02157519|2990832|Superiority||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.66||0.294|2-Sided|95.0|-2.0|0.61||threshold p <0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in physical QOL (FACT-Physical Well-Being) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) baseline from baseline to post-assessment.|
1628299|NCT02157519|2990832|Superiority||Mean Difference (Final Values)|-2.42|Standard Error of the Mean|1.65||0.144|2-Sided|95.0|-5.66|0.83||threshold p < 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in overall QOL (FACT-G) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.|
1628300|NCT02157519|2990833|Superiority||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.33||0.982|2-Sided|95.0|-0.64|0.65||threshold p <0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in symptom interference (MDASI-interference) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post assessment.|
1628301|NCT02157519|2990833|Superiority||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.21||0.603|2-Sided|95.0|-0.31|0.53||threshold p <0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the change in symptom severity (MDASI-severity) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.|
1628302|NCT02157519|2990834|Superiority||Mean Difference (Final Values)|-2.34|Standard Error of the Mean|4.06||0.57|2-Sided|95.0|-10.35|5.68||threshold p < 0.05|Regression, Linear|Adjusted for change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the percentage of medication taken (as recorded by MEMS) from baseline to post-assessment between groups adjusting for change in perceived social support (MSPSS) from baseline to post-assessment.|
1628303|NCT02157519|2990835|Superiority||Odds Ratio (OR)|0.56||||0.186|2-Sided|95.0|0.23|1.33||threshold p <0.05|Regression, Logistic|Adjusted for baseline MMAS-4 scores (dichotomous) and change in perceived social support (MSPSS) from baseline to post-assessment||Analysis comparing the number of participants who self-reported adherence problems (i.e., dichotomous MMAS-4 scores) at post-assessment between groups adjusting for baseline self-reported adherence (i.e., dichotomous MMAS-4 scores) and change in perceived social support (MSPSS) from baseline to post-assessment.|
1628304|NCT02157506|2990836|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628305|NCT02157506|2990836|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628306|NCT02157506|2990836|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628307|NCT02157506|2990836|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628308|NCT02157506|2990837|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628309|NCT02157506|2990837|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628310|NCT02157506|2990837|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628311|NCT02157506|2990837|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628312|NCT02157506|2990838|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628313|NCT02157506|2990838|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628314|NCT02157506|2990838|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628315|NCT02157506|2990838|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628316|NCT02157506|2990839|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628317|NCT02157506|2990839|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628318|NCT02157506|2990839|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628319|NCT02157506|2990839|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628320|NCT02157506|2990840|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628321|NCT02157506|2990840|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628322|NCT02157506|2990840|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628323|NCT02157506|2990840|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628324|NCT02157506|2990841|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628325|NCT02157506|2990841|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628326|NCT02157506|2990841|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628327|NCT02157506|2990841|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628328|NCT02157506|2990842|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628329|NCT02157506|2990842|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628330|NCT02157506|2990842|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628331|NCT02157506|2990842|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628332|NCT02157506|2990843|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628333|NCT02157506|2990843|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628334|NCT02157506|2990843|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628900|NCT02145156|2992165|Superiority or Other|||||||0.36|||||||Fisher Exact||||
1628335|NCT02157506|2990843|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628336|NCT02157506|2990844|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628337|NCT02157506|2990844|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628338|NCT02157506|2990844|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628339|NCT02157506|2990844|Superiority||||||=|0|||||||Mixed Models Analysis|Statistical significance was defined by a P-value < 0.05. No adjustments were made for multiplicity.|||
1628340|NCT02157376|2990847|Non-Inferiority or Equivalence|If the lower bound of the two-sided 95% confidence interval for the difference is larger than -0.05, the non-inferiority claim will be met.|Risk Difference (RD)|1.9||||0.393|2-Sided|95.0|-2.8|6.5|||Pearson's Chi-square||The difference in treatment group percentages is given by Cimetidine minus Esomeprazole.|Assuming a bleeding percent of 6.3% for the active comparator, a risk reduction of 3.7% for esomeprazole, and a 5% non-inferiority margin, 150 patients per treatment arm will provide 94% power to demonstrate non-inferiority. The null hypothesis is that the bleeding rate for iv esomeprazole 40 mg bid exceeds the rate for iv cimetidine by an amount at least as large as 5%.|
1628341|NCT02157298|2990848|Superiority or Other||Risk Difference (RD)|3.4|Standard Error of the Mean|3.769||0.3727|2-Sided|95.0|-4.0|10.7||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis & Davidian and Tsitatis, Davidian, Zhang & Lu, with adjustment with adjustment for baseline value and DPP-4||H0: proportion(dapa) minus proportion(placebo) = 0 versus alternative HA: proportion(dapa) minus proportion(placebo) =/= 0|
1628342|NCT02157298|2990849|Superiority or Other||Mean Difference (Final Values)|-0.72|Standard Error of the Mean|0.4017||0.0743|2-Sided|95.0|-1.51|0.07||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0|
1628343|NCT02157298|2990850|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.255|<|0.0001|2-Sided|95.0|-1.7|-0.7||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0|
1628344|NCT02157298|2990851|Superiority or Other||Mean Difference (Final Values)|-22.7|Standard Error of the Mean|5.301|<|0.0001|2-Sided|95.0|-33.2|-12.2||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0|
1628345|NCT02157298|2990852|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.1053|<|0.0001|2-Sided|95.0|-0.81|-0.39||Significant at alpha=0.05 (two-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Mixed Models Analysis|with fixed categorical effects of treatment, week, DPP-4, baseline eGFR, treatment-by-week interaction, continuous fixed covariate of baseline value.||H0: mean(dapa) minus mean(placebo) = 0 versus alternative HA: mean(dapa) minus mean(placebo) =/= 0|
1628346|NCT02157168|2990853|Superiority|||||||0.638||||||This comparison is an indication of whether the change seen between baseline and 6 months in the IG1 was due to the intervention or simply due to 6 months’ enrollment.|Chi-squared||||
1628347|NCT02157168|2990853|Superiority|||||||0.117||||||This comparison captures the change over the intervention period.|Chi-squared||||
1628348|NCT02157168|2990854|Superiority|||||||0.966||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared||||
1628349|NCT02157168|2990854|Superiority|||||||0.741||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)|
1628350|NCT02157168|2990855|Superiority|||||||0.691||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared||||
1628351|NCT02157168|2990855|Superiority|||||||0.889||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)|
1628352|NCT02157168|2990856|Superiority|||||||0.056||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared||||
1628353|NCT02157168|2990856|Superiority|||||||0.278||||||This comparison reflects intent to treat and compares the two randomized groups CG and IG (IG1+IG2).|Chi-squared|||CG and IG (IG1+IG2)|
1628354|NCT02157168|2990857|Superiority|||||||0.001||||||This comparison could be considered to be a per protocol analysis. Note, however, that the IG1 group was self-selected.|Chi-squared||||
1628355|NCT02157168|2990857|Superiority|||||||0.624||||||This comparison reflects intent to treat and is the main comparison in the study.|Chi-squared|||CG and IG (IG1+IG2)|
1628356|NCT02155985|2990969|Superiority or Other||Mean Difference (Net)|5.5||||0.14|2-Sided|95.0|-1.7|13.3||While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.|t-test, 2 sided||Mean difference is the percent difference in mean fold changes = ((100 mg mean fold change / placebo mean fold change) - 1) * 100.|Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.|
1628402|NCT02155660|2991001|Superiority||Mean Difference (Final Values)|-1.011||||0.3636|2-Sided|95.0|-3.192|1.171|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628357|NCT02155985|2990969|Superiority or Other||Mean Difference (Net)|1.4||||0.7|2-Sided|95.0|-5.5|8.8||While there are co-primary comparisons, due to the pilot nature of the study, no adjustment to the 0.05 type I error was made.|t-test, 2 sided||Mean difference is the percent difference in mean fold changes = ((300 mg mean fold change / placebo mean fold change) - 1) * 100.|Paired differences between the two aspirin arms and placebo were estimated in a single linear regression model using linear combinations of the estimated means.|
1628358|NCT02155881|2990970|Superiority or Other||Mean Difference (Net)|-0.39||||0.177|2-Sided|95.0|-0.95|0.18|||ANCOVA|||Emotional: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628359|NCT02155881|2990970|Superiority or Other||Mean Difference (Net)|-0.2||||0.4502|2-Sided|95.0|-0.74|0.33|||ANCOVA|||Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628360|NCT02155881|2990970|Superiority or Other||Mean Difference (Net)|-0.22||||0.4643|2-Sided|95.0|-0.82|0.38|||ANCOVA|||Nasal Symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628361|NCT02155881|2990970|Superiority or Other||Mean Difference (Net)|-0.36||||0.2683|2-Sided|95.0|-1.0|0.28|||ANCOVA|||Practical Problems: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628362|NCT02155881|2990970|Superiority or Other||Mean Difference (Net)|-0.2||||0.4098|2-Sided|95.0|-0.69|0.29|||ANCOVA|||Non-nose/Eye symptoms: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628363|NCT02155881|2990970|Superiority or Other||Mean Difference (Net)|-0.26||||0.3712|2-Sided|95.0|-0.84|0.32|||ANCOVA|||Sleep: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628364|NCT02155881|2990970|Superiority or Other||Mean Difference (Net)|-0.27||||0.3533|2-Sided|95.0|-0.85|0.31|||ANCOVA|||Activities: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628365|NCT02155881|2990971|Superiority or Other||Mean Difference (Net)|-0.28||||0.2968|2-Sided|95.0|-0.8|0.25|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628366|NCT02155881|2990972|Superiority or Other||Mean Difference (Net)|0.03||||0.8316|2-Sided|95.0|-0.22|0.27|||ANCOVA|||Tearing/Watering Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628367|NCT02155881|2990972|Superiority or Other||Mean Difference (Net)|-0.09||||0.4888|2-Sided|95.0|-0.35|0.17|||ANCOVA|||Redness: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628368|NCT02155881|2990972|Superiority or Other||Mean Difference (Net)|0.17||||0.2266|2-Sided|95.0|-0.11|0.46|||ANCOVA|||Itching/Burning Eyes: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628369|NCT02155881|2990973|Superiority or Other||Mean Difference (Net)|0.01||||0.9584|2-Sided|95.0|-0.29|0.3|||ANCOVA|||Sneezing: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628370|NCT02155881|2990973|Superiority or Other||Mean Difference (Net)|0.05||||0.7309|2-Sided|95.0|-0.22|0.31|||ANCOVA|||Itching: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628371|NCT02155881|2990973|Superiority or Other||Mean Difference (Net)|0.05||||0.7085|2-Sided|95.0|-0.22|0.33|||ANCOVA|||Runny nose: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628372|NCT02155881|2990973|Superiority or Other||Mean Difference (Net)|-0.08||||0.5593|2-Sided|95.0|-0.35|0.19|||ANCOVA|||Nasal congestion: An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628373|NCT02155881|2990974|Superiority or Other||Mean Difference (Net)|0.15||||0.663|2-Sided|95.0|-0.55|0.86|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628374|NCT02155881|2990975|Superiority or Other||Mean Difference (Net)|0.1||||0.7789|2-Sided|95.0|-0.61|0.81|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628375|NCT02155881|2990976|Superiority or Other||Mean Difference (Net)|0.08||||0.8713|2-Sided|95.0|-0.87|1.02|||ANCOVA|||An ANCOVA model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628376|NCT02155881|2990977|Superiority or Other||Mean Difference (Net)|0.02||||0.9716|2-Sided|95.0|-0.98|1.01|||ANCOVA|||An analysis of covariance (ANCOVA) model adjusted for treatment, site and the baseline score was used to test a null hypothesis of no difference between the treatment groups against a two-sided alternative hypothesis at the 5% level of significance.|
1628377|NCT02155738|2990979|Superiority||||||<|0.05|||||||t-test, 2 sided|||1b) We will use equianalgesic dosage tables to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. We hypothesize that those patients receiving preemptive IV acetaminophen will have lower postoperative VAS scores and reduced narcotic requirements compared to placebo.|
1628378|NCT02155738|2990980|Superiority||||||<|0.05|||||||Mixed Models Analysis|||Aim 1: Quantify the impact of IV acetaminophen on 1a) postoperative pain scores ... 1a) To achieve this aim, we will measure the degree of postoperative pain using visual analog scales (VAS) at multiple specified time points throughout the postoperative period; we report on change from Baseline VAS at 24 Hours Postop. Null Hypothesis is that there is no difference between subgroups in VAS scores. Sample size was determined considering significant differences in VAS scores.|
1628379|NCT02155660|2990990|Superiority||Rate ratio|0.67||||0.0185|2-Sided|95.0|0.48|0.94|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).|||
1628380|NCT02155660|2990990|Superiority||Rate ratio|0.89||||0.4631|2-Sided|95.0|0.65|1.22|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).|||
1628381|NCT02155660|2990990|Superiority||Rate ratio|0.68||||0.0287|2-Sided|95.0|0.49|0.96|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).|||
1628382|NCT02155660|2990992|Superiority||Odds Ratio (OR)|1.1||||0.5109|2-Sided|95.0|0.82|1.48|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with >=1 COPD exacerbation.|
1628383|NCT02155660|2990992|Superiority||Odds Ratio (OR)|1.39||||0.0323|2-Sided|95.0|1.03|1.87|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with >=1 COPD exacerbation.|
1628384|NCT02155660|2990992|Superiority||Odds Ratio (OR)|1.02||||0.9141|2-Sided|95.0|0.76|1.36|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with >=1 COPD exacerbation.|
1628385|NCT02155660|2990993|Superiority||Rate ratio|0.92||||0.3759|2-Sided|95.0|0.76|1.11|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.|||
1628386|NCT02155660|2990993|Superiority||Rate ratio|0.98||||0.8378|2-Sided|95.0|0.82|1.18|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.|||
1628387|NCT02155660|2990993|Superiority||Rate ratio|0.98||||0.8158|2-Sided|95.0|0.81|1.18|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.|||
1628388|NCT02155660|2990997|Superiority||Mean Difference (Final Values)|-0.026||||0.2008|2-Sided|95.0|-0.065|0.014|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628389|NCT02155660|2990997|Superiority||Mean Difference (Final Values)|-0.055||||0.0069|2-Sided|95.0|-0.094|-0.015|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628390|NCT02155660|2990997|Superiority||Mean Difference (Final Values)|-0.041||||0.0415|2-Sided|95.0|-0.081|-0.002|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628391|NCT02155660|2990998|Superiority||Mean Difference (Final Values)|-0.364||||0.065|2-Sided|95.0|-0.75|0.023|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628392|NCT02155660|2990998|Superiority||Mean Difference (Final Values)|-0.34||||0.0852|2-Sided|95.0|-0.727|0.047|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628393|NCT02155660|2990998|Superiority||Mean Difference (Final Values)|-0.642||||0.0012|2-Sided|95.0|-1.029|-0.254|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628394|NCT02155660|2990999|Superiority||Mean Difference (Final Values)|-0.425||||0.2336|2-Sided|95.0|-1.125|0.275|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628395|NCT02155660|2990999|Superiority||Mean Difference (Final Values)|-0.296||||0.4087|2-Sided|95.0|-0.998|0.406|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628396|NCT02155660|2990999|Superiority||Mean Difference (Final Values)|-0.4||||0.2636|2-Sided|95.0|-1.102|0.301|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628397|NCT02155660|2991000|Superiority||Mean Difference (Final Values)|-0.1||||0.8204|2-Sided|95.0|-1.0|0.79|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628398|NCT02155660|2991000|Superiority||Mean Difference (Final Values)|-0.01||||0.987|2-Sided|95.0|-0.91|0.89|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628399|NCT02155660|2991000|Superiority||Mean Difference (Final Values)|0.09||||0.8525|2-Sided|95.0|-0.82|0.99|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628400|NCT02155660|2991001|Superiority||Mean Difference (Final Values)|-0.602||||0.5851|2-Sided|95.0|-2.763|1.56|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628401|NCT02155660|2991001|Superiority||Mean Difference (Final Values)|-1.388||||0.2106|2-Sided|95.0|-3.562|0.786|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628901|NCT02144675|2992186|Other||||||<|0.05|||||||Regression, Cox||||
1628403|NCT02155660|2991002|Superiority||Mean Difference (Final Values)|0.02||||0.3767|2-Sided|95.0|-0.024|0.064|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628404|NCT02155660|2991002|Superiority||Mean Difference (Final Values)|-0.007||||0.7691|2-Sided|95.0|-0.051|0.037|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628405|NCT02155660|2991002|Superiority||Mean Difference (Final Values)|0.015||||0.5043|2-Sided|95.0|-0.029|0.059|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1628406|NCT02155660|2991003|Superiority||Rate ratio|1.02||||0.8644|2-Sided|95.0|0.8|1.3|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.|||
1628407|NCT02155660|2991003|Superiority||Rate ratio|1.08||||0.5573|2-Sided|95.0|0.84|1.37|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.|||
1628408|NCT02155660|2991003|Superiority||Rate ratio|1.04||||0.7564|2-Sided|95.0|0.82|1.32|||Negative binomial|Model includes treatment group, region, background therapy, number of exacerbations in the previous year.|||
1628409|NCT02155660|2991004|Superiority||Rate ratio|0.93||||0.3988|2-Sided|95.0|0.78|1.1|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.|||
1628410|NCT02155660|2991004|Superiority||Rate ratio|1.04||||0.6575|2-Sided|95.0|0.88|1.23|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.|||
1628411|NCT02155660|2991004|Superiority||Rate ratio|0.85||||0.0638|2-Sided|95.0|0.71|1.01|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.|||
1628412|NCT02155608|2991011|Superiority|||||||1||||||Test not valid due to insufficient data.|Mixed Models Analysis|Group * time: F = .87, df = 1/0.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628413|NCT02155608|2991011|Superiority|||||||1||||||Test not valid due to insufficient data.|Mixed Models Analysis|Time: F = 0.00, df = 1/0.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628414|NCT02155608|2991011|Superiority|||||||0.21|||||||Mixed Models Analysis|Group: F = 1.72, df = 1/12.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628415|NCT02155608|2991011|Superiority|||||||0.22|||||||Mixed Models Analysis|Group * time: F = 1.56; df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.|
1628416|NCT02155608|2991011|Superiority|||||||0.18|||||||Mixed Models Analysis|Time2: F = 1.88, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.|
1628417|NCT02155608|2991011|Superiority|||||||0.39|||||||Mixed Models Analysis|Time: F = .74, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.|
1628418|NCT02155608|2991011|Superiority|||||||0.21|||||||Mixed Models Analysis|Group: F = 1.62, df = 1/58.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parametrized in the model as a standard linear viable, time (ranging from baseline to 4 weeks) and a second variable, time2. defined as 0 at baseline and time past week 1 for subsequent weeks. The time 2 coefficient represents the change in slope after the initial week.|
1628419|NCT02155608|2991012|Superiority|||||||0.73|||||||Mixed Models Analysis|Group * time: F = .12, df = 1/43||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628420|NCT02155608|2991012|Superiority|||||||0.04|||||||Mixed Models Analysis|Time: F = 4.52, df = 1/43||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628421|NCT02155608|2991012|Superiority|||||||0.83|||||||Mixed Models Analysis|Group: F = .05, df = 1/59||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628422|NCT02155608|2991012|Superiority|||||||0.81|||||||Mixed Models Analysis|Group * time: F = .06, df = 1/52||Phase 1 a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interaction to test for treatment effects.|
1628423|NCT02155608|2991012|Superiority|||||||0.34|||||||Mixed Models Analysis|Time: F = .09, df = 1/52||Phase 1a: Outcomes were fitted via a mixed model with group, time, and group-by-time interactions to test for treatment effects.|
1628424|NCT02155608|2991012|Superiority|||||||0.55|||||||Mixed Models Analysis|Group: F = .36, df = 1/52||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628425|NCT02155608|2991013|Superiority|||||||0.07||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = 3.35, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628524|NCT02152371|2991377|Superiority or Other (legacy)||Odds Ratio (OR)|4.17|||<|0.001|2-Sided|95.0|2.32|7.47|||Regression, Logistic||||
1628426|NCT02155608|2991013|Superiority|||||||0.82||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = .05, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628427|NCT02155608|2991013|Superiority|||||||0.14||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = 2.24, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628428|NCT02155608|2991013|Superiority|||||||0.03||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = 4.61, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628429|NCT02155608|2991013|Superiority|||||||0.3||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.10, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628430|NCT02155608|2991013|Superiority|||||||0.79||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = .07, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628431|NCT02155608|2991014|Superiority|||||||0.92||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = .01, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628432|NCT02155608|2991014|Superiority|||||||0.96||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = 0.00, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628433|NCT02155608|2991014|Superiority|||||||0.05||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = 3.95, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628434|NCT02155608|2991014|Superiority|||||||0.22||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = 1.49, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628435|NCT02155608|2991014|Superiority|||||||0.19||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.49, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628436|NCT02155608|2991014|Superiority|||||||0.64||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = .22, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628437|NCT02155608|2991015|Superiority|||||||0.22||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = 1.55, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628438|NCT02155608|2991015|Superiority|||||||0.79||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = .07, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628439|NCT02155608|2991015|Superiority|||||||0.09||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = 3.06, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628440|NCT02155608|2991015|Superiority|||||||0.39||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = .75, df =1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628441|NCT02155608|2991015|Superiority|||||||0.76||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = .09, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628442|NCT02155608|2991015|Superiority|||||||0.94||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628443|NCT02155608|2991016|Superiority|||||||0.79||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = .07, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628444|NCT02155608|2991016|Superiority|||||||0.05||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = 4.15, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628445|NCT02155608|2991016|Superiority|||||||0.15||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F= 2.16, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628446|NCT02155608|2991016|Superiority|||||||0.01||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = 6.89, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628447|NCT02155608|2991016|Superiority|||||||0.02||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = 5.18, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628448|NCT02155608|2991016|Superiority|||||||0.21||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = 1.62, df = 1/128.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628449|NCT02155608|2991017|Superiority|||||||0.35||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = .88, df = 1/54.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1630047|NCT02123511|2994075|Superiority|||||||0.02|||||||t-test, 1 sided||||
1628450|NCT02155608|2991017|Superiority|||||||0.33||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = .98, df = 1/54.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628451|NCT02155608|2991017|Superiority|||||||0.69||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = .16, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628452|NCT02155608|2991017|Superiority|||||||0.31||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = 1.03, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628453|NCT02155608|2991017|Superiority|||||||0.02||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = 5.83, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628454|NCT02155608|2991017|Superiority|||||||0.29||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = 0.29, df = 1/129.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628455|NCT02155608|2991018|Superiority|||||||0.42||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = .66, df = 1/31.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628456|NCT02155608|2991018|Superiority|||||||0.05||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = 4.20, df = 1/31.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628457|NCT02155608|2991018|Superiority|||||||0.06||||||p < .05 for statistical significance|Mixed Models Analysis|Group: F = 3.36, df = 1/58.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628458|NCT02155608|2991018|Superiority|||||||0.09||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = 2.90, df 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628459|NCT02155608|2991018|Superiority|||||||0.06|||||||Mixed Models Analysis|Time: F = 3.58, df = 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628460|NCT02155608|2991018|Superiority|||||||0.62|||||||Mixed Models Analysis|Group: F =.25, df = 1/53.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628461|NCT02155608|2991019|Superiority|||||||0.72||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = .13, df = 1/38.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628462|NCT02155608|2991019|Superiority|||||||0.18||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = 1.87, df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628463|NCT02155608|2991019|Superiority|||||||0.49||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = .48. df = 1/55.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628464|NCT02155608|2991019|Superiority|||||||0.4||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = .71; df = .40.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628465|NCT02155608|2991019|Superiority|||||||0.11||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.62, df = 1/46.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628466|NCT02155608|2991019|Superiority|||||||0.91||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = .01; df = 1/46.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628467|NCT02155608|2991020|Superiority|||||||0.28||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = 1.23, df = 1/35.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628468|NCT02155608|2991020|Superiority|||||||0.15||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.22, df = 1/35.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628469|NCT02155608|2991020|Superiority|||||||0.93||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/58.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628470|NCT02155608|2991020|Superiority|||||||0.8||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = .06, df = .81.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628471|NCT02155608|2991020|Superiority|||||||0.14||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.28, df = 1/55.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628472|NCT02155608|2991020|Superiority|||||||0.89||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = .02, df = 1/55.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628473|NCT02155608|2991021|Superiority|||||||0.81||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = .06, df = 1/47.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628525|NCT02152371|2991378|Superiority or Other (legacy)||Odds Ratio, log|5.71|||<|0.001|2-Sided|95.0|3.35|9.73|||Regression, Logistic||||
1628474|NCT02155608|2991021|Superiority|||||||0.48||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = .50, df = 1/47.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628475|NCT02155608|2991021|Superiority|||||||0.66||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = .20, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628476|NCT02155608|2991021|Superiority|||||||0.64||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = .21, df = 1/56.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628477|NCT02155608|2991021|Superiority|||||||0.15||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = 2.12, df = .15||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628478|NCT02155608|2991021|Superiority|||||||0.91||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = .01, df = 1/56.||Phase 1a: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects.|
1628479|NCT02155608|2991022|Superiority|||||||0.16||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = 2.05, df = 1/50.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628480|NCT02155608|2991022|Superiority|||||||0.68||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = .17, df = 1/50.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628481|NCT02155608|2991022|Superiority|||||||0.67||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = .19, df = 1/59.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628482|NCT02155608|2991022|Superiority|||||||0.007||||||Time2: F = 7.45, df = 1/209.|Mixed Models Analysis|||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.|
1628483|NCT02155608|2991022|Superiority|||||||0.37|||||||Mixed Models Analysis|Group * time: F = .83; df = 1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.|
1628484|NCT02155608|2991022|Superiority|||||||0.0004|||||||Mixed Models Analysis|Time: F=13.03; df = 1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.|
1628485|NCT02155608|2991022|Superiority|||||||0.91|||||||Mixed Models Analysis|Group: F=.01; df =1/209.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.|
1628486|NCT02155608|2991023|Superiority|||||||0.46|||||||Chi-squared|Group: Chi-square = .53, df = 1.||Phase 1b: Assessed effects of group on categorical measure CGI-I from at Visit 5 compared to baseline.|
1628487|NCT02155608|2991023|Superiority|||||||0.17||||||p < .05 for statistical significance.|Chi-squared|Time: F = 1.69, df = 3/168.||Phase 1a: Assessed effects of group and time on categorical measure CGI-I from Baseline through Visit 4.|
1628488|NCT02155608|2991023|Superiority|||||||0.003||||||p < .05 for statistical significance|Chi-squared|Group: F = 8.75, df = 1/168.||Phase 1a: Assessed effects of group and time on categorical measure CGI-I from Baseline through Visit 4.|
1628489|NCT02155608|2991024|Superiority|||||||0.73||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = .12, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628490|NCT02155608|2991024|Superiority|||||||0.05||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = 4.18, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628491|NCT02155608|2991024|Superiority|||||||0.02||||||p < .05 for statistical significance.|Mixed Models Analysis|Time: F = 6.23, df = 1/57.||Phase 1b: Outcomes were fitted via a mixed effects model with group, time, and group-by-time interactions to test for treatment effects between visits 4 and 5.|
1628492|NCT02155608|2991024|Superiority||||||<|0.0001||||||p < .05 for statistical significance.|Mixed Models Analysis|Time2: F = 28.96, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.|
1628493|NCT02155608|2991024|Superiority||||||<|0.005||||||p < .05 for statistical significance.|Mixed Models Analysis|Group * time: F = 8.12, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.|
1628494|NCT02155608|2991024|Superiority||||||<|0.0001||||||p < .05 for statistical significance|Mixed Models Analysis|Time: F=39.97, df = 1/228||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.|
1628495|NCT02155608|2991024|Superiority||||||<|0.54||||||p < .05 for statistical significance.|Mixed Models Analysis|Group: F = .38, df = 1/228.||Phase 1a: Outcomes were fitted via a mixed effects model with group-by-time interactions to test for treatment effects using a piecewise linear time trend. This was parameterized in the model as a standard linear variable, time (ranging from baseline to 4 weeks) and a second variable, time2, defined as 0 at baseline and time past week 1 for subsequent weeks. The time2 coefficient represents the change in slope after the initial week.|
1628496|NCT02155257|2991043|Other||Slope|0.19||||0.54|2-Sided|95.0|-0.39|0.76|||Regression, Linear|||Interaction between resting pupil diameter and correlation of cognitive-affective style to pain reporting. Note that this analysis is an INTERACTION between the primary outcome of this measure (pupil diameter) to that of the primary outcome measure of cognitive-affective style.|
1628497|NCT02154347|2991133|Superiority||Mean Difference (Final Values)|-0.66|||<|0.001|2-Sided|95.0|-0.95|-0.37|||t-test, 2 sided||||
1628498|NCT02153723|2991177|Other|Wilcoxon signed rank sum test|Median Difference (Final Values)|0.0||||0.44|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1628499|NCT02153723|2991178|Other|Wilcoxon signed rank sum test|Mean Difference (Final Values)|0.8||||0.86|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1628500|NCT02153723|2991179|Other|Wilcoxon signed rank sum test|Median Difference (Final Values)|15.9||||0.08|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1628501|NCT02153723|2991180|Other|Wilcoxon signed rank sum test|Median Difference (Final Values)|-0.1||||0.004|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1628502|NCT02153723|2991181|Other|Wilcoxon signed rank sum test|Median Difference (Final Values)|-2.0||||0.03|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1628503|NCT02153723|2991182|Other|Wilcoxon signed rank sum test|Median Difference (Final Values)|21.6||||0.03|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1628504|NCT02153645|2991223|Superiority||Mean Difference (Final Values)|-3.1|Standard Error of the Mean|2.95||0.458|2-Sided|95.0|-11.2|5.1|||ANCOVA||||
1628505|NCT02153645|2991223|Superiority or Other||Mean Difference (Final Values)|-5.6|Standard Error of the Mean|2.9||0.179|2-Sided|95.0|-13.9|2.6|||ANCOVA||||
1628506|NCT02153632|2991225|Superiority||Mean Difference (Final Values)|-6.5|Standard Error of the Mean|1.71||0.011|2-Sided|95.0|-11.5|-1.5|||ANCOVA||||
1628507|NCT02153632|2991225|Superiority||Mean Difference (Final Values)|-5.5|Standard Error of the Mean|1.75||0.031|2-Sided|95.0|-10.5|-0.5|||ANCOVA||||
1628508|NCT02152631|2991351|Superiority||LS Mean Change Difference|0.0|Standard Error of the Mean|0.02||0.951|2-Sided|95.0|-0.05|0.05|||Mixed Models Analysis|Analyzed By Type 3 sums of squares, Change from Baseline = Treatment + Visit + Treatment*Visit + Baseline.|||
1628509|NCT02152631|2991353|Superiority||LS Mean Change Difference|-0.2|Standard Error of the Mean|0.15||0.188|2-Sided|95.0|-0.51|0.1|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.||Mean Core Plus Lung Cancer|
1628510|NCT02152631|2991353|Superiority||LS Mean Change Difference|-0.07|Standard Error of the Mean|0.15||0.646|2-Sided|95.0|-0.37|0.23|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.||Mean Lung Cancer|
1628511|NCT02152631|2991353|Superiority||LS Mean Change Difference|-0.15|Standard Error of the Mean|0.23||0.514|2-Sided|95.0|-0.59|0.3|||Mixed Models Analysis|Analyzed by Type 3 sums of square, model covariates included Treatment + Visit + Treatment*Visit + Baseline.||Mean Interference|
1628512|NCT02152631|2991353|Superiority||LS Mean Change Difference|-0.24|Standard Error of the Mean|0.16||0.142|2-Sided|95.0|-0.56|0.08|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.||Mean Core Symptom Severity|
1628513|NCT02152631|2991353|Superiority||LS Mean Change Difference|-2.4|Standard Error of the Mean|0.27|<|0.001|2-Sided|95.0|-2.94|-1.86|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.||Rash|
1628514|NCT02152631|2991353|Superiority||LS Mean Change Difference|0.59|Standard Error of the Mean|0.28|<|0.038|2-Sided|95.0|0.03|1.15|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.||Diarrhea|
1628515|NCT02152631|2991353|Superiority||LS Mean Change Difference|-0.07|Standard Error of the Mean|0.19|<|0.698|2-Sided|95.0|-0.44|0.29|||Mixed Models Analysis|Analyzed by Type 3 sums of squares, model covariates included Treatment + Visit + Treatment*Visit + Baseline.||Headache|
1628516|NCT02152631|2991354|Superiority||Hazard Ratio (HR)|0.583|||<|1e-06|2-Sided|95.0|0.47|0.723|||Stratified Log-Rank||||
1628517|NCT02152631|2991355|Superiority|||||||0.01|||||||Cochran-Mantel-Haenszel|||Stratified by number of prior chemotherapy regimens (1 versus 2), ECOG PS (0 versus 1), gender (male versus female), and KRAS mutation (GLY12CYS [G12C] vs. all others)|
1628518|NCT02152631|2991356|Superiority||Hazard Ratio (HR)|0.968||||0.771|2-Sided|95.0|0.768|1.219|||Stratified Log-Rank||Hazard Ratio (HR) was estimated based on Stratified Cox proportional hazard model.|The stratification factors used in the analysis were: number of prior chemotherapy regimens (1 versus 2), Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) (0 versus 1), gender (male versus female), and kirsten rat sarcoma (KRAS) mutation (GLY12CYS [G12C] vs. all others)|
1628519|NCT02152605|2991357|Superiority or Other||Least Squares Mean Difference|-0.7|||<|0.001|2-Sided|95.0|-1.1|-0.4|||Mixed Models Analysis||||
1628520|NCT02152605|2991358|Superiority or Other||Least Squares Mean Difference|0.122|||<|0.001|2-Sided|95.0|0.071|0.172|||Mixed Models Analysis||||
1628521|NCT02152605|2991359|Superiority or Other||Least Squares Mean Difference|-4.03|||<|0.001|2-Sided|95.0|-6.28|-1.79|||Mixed Models Analysis||||
1628522|NCT02152371|2991375|Superiority or Other (legacy)||Odds Ratio (OR)|5.6|||<|0.001|2-Sided|95.0|3.26|9.62|||Regression, Logistic||||
1628523|NCT02152371|2991376|Superiority or Other (legacy)||Odds Ratio (OR)|3.61|||<|0.001|2-Sided|95.0|2.09|6.23|||Regression, Logistic||||
1628527|NCT02152371|2991385|Superiority or Other (legacy)||LS Means Diff|-13.19|Standard Error of the Mean|3.21|<|0.001|2-Sided|95.0|-19.55|-6.84|||MMRM||||
1628528|NCT02152371|2991386|Superiority or Other (legacy)||LS Means Difference|-2.41|Standard Error of the Mean|0.39|<|0.001|2-Sided|95.0|-3.19|-1.64|||Mixed Models Analysis||||
1628529|NCT02152371|2991387|Superiority or Other (legacy)||LS Mean Diff|-19.48|Standard Error of the Mean|4.72|<|0.001|2-Sided|95.0|-28.77|-10.18|||Mixed Models Analysis|||3:00AM (Morning)|
1628530|NCT02152371|2991387|Superiority or Other (legacy)||LS Mean Diff|-21.28|Standard Error of the Mean|5.68|<|0.001|2-Sided|95.0|-32.46|-10.1|||Mixed Models Analysis|||Evening Meal 2-Hour Postprandial|
1628531|NCT02152371|2991387|Superiority or Other (legacy)||LS Mean Diff|-14.96|Standard Error of the Mean|4.55|<|0.001|2-Sided|95.0|-23.93|-5.99|||Mixed Models Analysis|||Pre-Evening Meal|
1628532|NCT02152371|2991387|Superiority or Other (legacy)||LS Mean Diff|-18.15|Standard Error of the Mean|4.58|<|0.001|2-Sided|95.0|-27.18|-9.12|||Mixed Models Analysis|||Midday Meal 2-Hour Postprandial|
1628533|NCT02152371|2991387|Superiority or Other (legacy)||LS Mean Diff|-15.55|Standard Error of the Mean|4.08|<|0.001|2-Sided|95.0|-23.58|-7.52|||Mixed Models Analysis|||Pre-Midday Meal|
1628534|NCT02152371|2991387|Superiority or Other (legacy)||LS Mean Diff|-17.18|Standard Error of the Mean|4.45|<|0.001|2-Sided|95.0|-25.96|-8.4|||Mixed Models Analysis|||Morning Meal 2-Hour Postprandial|
1628535|NCT02152371|2991387|Superiority or Other (legacy)||LS Mean Diff|-8.06|Standard Error of the Mean|2.95|<|0.007|2-Sided|95.0|-13.87|-2.25|||Mixed Models Analysis|||Pre-Morning Meal|
1628536|NCT02152371|2991388|Superiority or Other (legacy)||LS Mean Diff|-16.73|Standard Error of the Mean|4.72|<|0.001|2-Sided|95.0|-26.02|-7.44|||Mixed Models Analysis||||
1628537|NCT02152371|2991389|Superiority or Other (legacy)||LS Means Diff|-0.77|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.97|-0.56|||Mixed Model for Repeated Measures (MMRM)||||
1628538|NCT02151981|2991408|Superiority or Other (legacy)||Difference in LS means|-21.62|||<|0.001|2-Sided|95.0|-27.71|-15.52|||ANCOVA|Covariates for ethnicity (Asian, non-Asian) and the baseline sum of diameters of target lesions|LS Mean: AZD9291 -46.93, Chemo -25.3 A difference in LS means <0 favours AZD9291 80mg||
1628539|NCT02151981|2991409|Superiority or Other (legacy)||Odds Ratio (OR)|4.76|||<|0.001|2-Sided|95.0|2.64|8.84|||Regression, Logistic||Adjusted response rate: AZD9291 93.7, Chemo 75.7||
1628540|NCT02151981|2991410|Superiority or Other (legacy)||Ratio of Expected (DoR)|6.22|||<|0.001|2-Sided|95.0|4.04|9.57|||formulae provided in Ellis S et al 2008|Treatments compared by calculating the ratio of the Expected (DoR) using the Log Normal probability distribution for DOR in responding patients|||
1628541|NCT02151981|2991411|Superiority or Other (legacy)||Odds Ratio (OR)|5.39|||<|0.001|2-Sided|95.0|3.47|8.48|||Regression, Logistic|adjusted for ethnicity (Asian/non-Asian)|Adjusted response rate: AZD9291 72.8, Chemo 33.1||
1628542|NCT02151981|2991412|Superiority or Other (legacy)||Hazard Ratio (HR)|0.3|||<|0.001|2-Sided|95.0|0.23|0.41|||Log Rank||A hazard ratio <1 favours AZD9291 80mg||
1628543|NCT02151877|2991417|Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Null: NO group fluid balances are the same as the control|
1628544|NCT02151877|2991418|Other||||||>|0.05||||||This test applies to the first marker, cardiac troponin I.|t-test, 2 sided|||Null: mean cardiac troponin I changes in the NO group = mean cardiac troponin I changes in the control|
1628545|NCT02151851|2991420|Superiority or Other||Odds Ratio (OR)|7.248|||<|0.001|2-Sided|95.0|2.209|23.786||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic||||
1628546|NCT02151851|2991421|Superiority or Other||Odds Ratio (OR)|7.641|||<|0.001|2-Sided|95.0|3.57|16.352||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic||||
1628547|NCT02151851|2991422|Superiority or Other||Odds Ratio (OR)|3.899|||<|0.001|2-Sided|95.0|2.382|6.382||Difference of CZP + MTX versus Placebo + MTX (and corresponding p-value) was estimated from a logistic regression model with factors for treatment and region.|Regression, Logistic||||
1628548|NCT02151682|2991451|Non-Inferiority|A logistic regression model was fitted to the response using baseline pain, age group, treatment, and underlying pain condition as explanatory variables, followed by a Farrington-Manning test for non-inferiority, based on Full Analysis Set.|Risk Difference (RD)|-0.06||||0.079|2-Sided|80.0|-0.19|0.06||The p-value is based on Farrington-Manning variance estimator using a pre-specified non-inferiority margin of -0.2. A 1-sided alpha of 0.1 was used. A p-value <0.1 represents non-inferiority.|Farrington-Manning test|Non-inferiority of tapentadol prolonged-release versus morphine prolonged-release has been demonstrated.|A confidence interval for the risk difference (RD) completely above the pre-specified non-inferiority margin of -0.2 represents non-inferiority of tapentadol prolonged-release versus morphine prolonged-release.||
1628549|NCT02151643|2991452|Other|||||||0.288|||||||paired z-test||||
1628550|NCT02151643|2991452|Other|||||||0.872|||||||paired z-test||||
1628551|NCT02151643|2991452|Other|||||||0.047|||||||paired z-test||||
1628552|NCT02151643|2991452|Other|||||||0.292|||||||paired z-test||||
1628553|NCT02151643|2991453|Other||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Baseline Calcium x Phosphate Product.|
1628554|NCT02151643|2991453|Other||||||<|0.004|||||||ANCOVA|||Repeated measures ANCOVA for change in Calcium x Phosphate Product from Baseline by PT20 dose group.|
1628555|NCT02151643|2991454|Other||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Baseline Transferrin Saturation.|
1628556|NCT02151643|2991454|Other||||||<|0.013|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by Visit.|
1628557|NCT02151643|2991454|Other||||||<|0.068|||||||ANCOVA|||Repeated measures ANCOVA for change in transferrin saturation from Baseline by PT20 dose group.|
1628558|NCT02151643|2991455|Other|||||||0.186|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by baseline serum ferritin concentration|
1628559|NCT02151643|2991455|Other|||||||0.867|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by Visit.|
1628560|NCT02151643|2991455|Other|||||||0.243|||||||ANCOVA|||Repeated measures ANCOVA for change in serum ferritin concentration from Baseline by PT20 dose group.|
1628561|NCT02151643|2991456|Other||||||<|0.001|||||||ANCOVA|||Repeated measures ANCOVA for change in haemoglobin concentration from Baseline by baseline hemoglobin.|
1628562|NCT02151643|2991456|Other||||||<|0.497|||||||ANCOVA|||Repeated measures ANCOVA for change in haemoglobin concentration from Baseline by PT20 dose group.|
1628563|NCT02151643|2991457|Other||Mean Difference (Final Values)|-1.195|Standard Error of the Mean|0.255|||1-Sided|97.5||-0.618||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration|
1628564|NCT02151643|2991457|Other||Mean Difference (Final Values)|-0.705|Standard Error of the Mean|0.2891|||1-Sided|97.5||-0.05||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration|
1628565|NCT02151643|2991457|Other||Mean Difference (Final Values)|0.007|Standard Error of the Mean|0.2881|||1-Sided|97.5||0.659||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration|
1628566|NCT02151643|2991457|Other||Mean Difference (Final Values)|0.117|Standard Error of the Mean|0.2847|||1-Sided|97.5||0.761||||||ITT population supportive analysis - mixed model repeated measures for change in serum phosphate concentration|
1628567|NCT02151643|2991457|Other|||||||0.144|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - baseline serum phosphate concentration versus Visit interaction|
1628568|NCT02151643|2991457|Other||||||<|0.001|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - baseline serum phosphate concentration|
1628569|NCT02151643|2991457|Other||||||<|0.959|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - treatment group versus Visit interaction|
1628570|NCT02151643|2991457|Other||||||<|0.436|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - visit|
1628571|NCT02151643|2991457|Other||||||<|0.001|||||||Mixed Models Analysis|||ITT population supportive analysis - Type 3 tests of fixed effects - treatment group|
1628572|NCT02151643|2991457|Other|The primary analysis was a linear model which attempted to explain change from Baseline (Visit 7) to Day 29 (Visit 11) in serum phosphate concentration based on log-transformed dose level (assuming that placebo was equally spaced below the lowest dose level), and stratified by pre-randomisation serum phosphate level (< 7.5 mg/dL or ≥ 7.5 mg/dL). Missing assessments were imputed using the subject’s last observed phosphate concentration value (Last Observation Carried Forward [LOCF] imputation).|Slope|-0.329|||<|0.001|2-Sided||||||linear model - log (dose) - response|||ITT population - statistical analysis of the linear model log(PT20 dose)-response relationship to examine whether the linear trend of the change in phosphate level as a function of the log-transformed dose was statistically significant.|
1628573|NCT02151643|2991457|Other|Sensitivity analysis of the primary ITT analysis using the Per Protocol (PP) population.|||||<|0.914|||||||F-test|||"Per protocol (PP) population sensitivity analysis to assess statistical analysis of linear model fit using an F-test at the 0.05 level."|
1628574|NCT02151643|2991457|Other|Sensitivity analysis of ITT primary analysis using multiple imputation (MI) for any missing Day 29 (Visit 11) serum phosphate values.|||||<|0.976|||||||F-test|||"ITT population sensitivity analysis using multiple imputation (MI) to assess statistical analysis of linear model fit using an F-test at the 0.05 level."|
1628575|NCT02151643|2991457|Other|Sensitivity analysis of ITT primary analysis using baseline observation carried forward (BOCF) for any missing Day 29 (Visit 11) serum phosphate values.|||||<|0.905|||||||F-test|||"ITT population sensitivity analysis using baseline observation carried forward (BOCF) to assess statistical analysis of linear model fit using an F-test at the 0.05 level."|
1628576|NCT02151643|2991457|Other|The primary analysis was a linear model which attempted to explain change from Baseline (Visit 7) to Day 29 (Visit 11) in serum phosphate concentration based on log-transformed dose level (assuming that placebo was equally spaced below the lowest dose level), and stratified by pre-randomisation serum phosphate level (< 7.5 mg/dL or ≥ 7.5 mg/dL). Missing assessments were imputed using the subject’s last observed phosphate concentration value (Last Observation Carried Forward [LOCF] imputation).|||||<|0.784|||||||F-test|||"ITT population - statistical analysis of linear model fit using an F-test at the 0.05 level.~It was determined that 150 subjects randomised at a ratio of 8:8:8:13:13 (low dose to high dose, placebo) would have >90% power to detect either a statistically significant slope for the dose-response relationship, or, if the relationship was not linear, a statistically significant difference between the highest-dose group and the placebo group, using a two-sided 0.05 significance level."|
1628577|NCT02151461|2991481|Other|||||||0.748|||||||ANCOVA||||
1628578|NCT02151461|2991481|Other|||||||0.841|||||||ANCOVA||||
1628579|NCT02151461|2991481|Other|||||||0.9789|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group|||
1628580|NCT02151461|2991482|Other|Plasma Insulin Absolute AUC(0-2hr) (h*uIU/mL)||||||0.8407|||||||ANCOVA||||
1628581|NCT02151461|2991482|Other|Plasma Insulin Absolute AUC(0-2hr) (h*uIU/mL)||||||0.5677|||||||ANCOVA||||
1628582|NCT02151461|2991482|Other|Plasma Insulin Absolute AUC(0-2hr) (h*uIU/mL)||||||0.3143|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise comparison using Treatment D as the reference group.|||
1628583|NCT02151461|2991483|Other|Average Change in Post-meal Glucose Level||||||0.1289|||||||ANCOVA||||
1628584|NCT02151461|2991483|Other|Average Change in Post-meal Glucose Level||||||0.0085|||||||ANCOVA||||
1628585|NCT02151461|2991483|Other|Average Change in Post-meal Glucose Level||||||0.1273|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group|||
1628586|NCT02151461|2991483|Other|Average Change in Pre-meal Glucose Level||||||0.0284|||||||ANCOVA||||
1628587|NCT02151461|2991483|Other|Average Change in Pre-meal Glucose Level||||||0.0152|||||||ANCOVA||||
1628588|NCT02151461|2991483|Other|Average Change in Pre-meal Glucose Level||||||0.011|||||||ANCOVA|Total daily dose is twice the respective dose Pairwise comparison using Treatment D as the reference group|||
1628589|NCT02151461|2991484|Other|||||||0.3117|||||||ANCOVA||||
1628590|NCT02151461|2991484|Other|||||||0.4144|||||||ANCOVA||||
1628687|NCT02148952|2991775|Superiority||Other|0.0|||<|0.001|2-Sided||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Partography started|
1628902|NCT02144610|2992188|Superiority or Other|||||||0.835|||||||ANCOVA|||Change from Baseline at LOCF|
1628591|NCT02151461|2991484|Other|||||||0.2177|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise Comparison using Treatment D as the Reference Group||The HOMA Calculator,is an algorithm that takes account of variations in hepatic and peripheral glucose resistance, increases in insulin secretion curve for plasma glucose concentrations above 10 mmol/L (180 mg/dL), and contribution of circulating proinsulin (eg, C-peptide) to estimate steady state beta cell function (%HOMA-B) and insulin sensitivity (%HOMA-S), as percentages of a normal reference population. %HOMA-IR was analyzed on a logarithmic scale (natural logarithmic transformation).|
1628592|NCT02151461|2991485|Other|||||||0.0578|||||||ANCOVA||||
1628593|NCT02151461|2991485|Other|||||||0.376|||||||ANCOVA||||
1628594|NCT02151461|2991485|Other|||||||0.0089|||||||ANCOVA|Total daily dose is twice the respective dose. Pairwise Comparison using Treatment D as the Reference Group|||
1628595|NCT02151461|2991486|Other|||||||0.0475|||||||ANCOVA||||
1628596|NCT02151461|2991486|Other|||||||0.0736|||||||ANCOVA||||
1628597|NCT02151461|2991486|Other|||||||0.0179|||||||ANCOVA|Total daily dose is twice the respective dose, Pairwise comparison using Treatment D as the reference group|||
1628598|NCT02151461|2991487|Other|||||||0.2518|||||||ANCOVA||||
1628599|NCT02151461|2991487|Other|||||||0.7641|||||||ANCOVA||||
1628600|NCT02151461|2991487|Other|A mixed-effects model for analysis of covariance (ANCOVA) was used to analyze changes from Baseline in incremental plasma glucose AUC at Week 4 in the Day 28 Evaluable population. The model will include factors for treatment group and fasting plasma glucose stratum.||||||0.8867|||||||ANCOVA|The model includes factors for treatment group and fasting plasma glucose stratum.|||
1628601|NCT02151461|2991488|Other|||||||0.1216|||||||ANCOVA||||
1628602|NCT02151461|2991488|Other|||||||0.065|||||||ANCOVA||||
1628603|NCT02151461|2991488|Other|A mixed-effects model for analysis of covariance (ANCOVA) was used to analyze changes from Baseline in plasma glucose AUC(0-3hr) at Week 4 in the Day 28 Evaluable population. The model includes factors for treatment group and fasting plasma glucose stratum.||||||0.0435||||||Baseline plasma glucose AUC(0-3hr) is adjusted as a covariate.|ANCOVA||||
1628604|NCT02151149|2991534|Superiority||Risk Ratio (RR)|1.56||||0.0597|2-Sided|95.0|0.971|2.511|||Cochran-Mantel-Haenszel|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma)..|||
1628605|NCT02151149|2991535|Superiority||Hazard Ratio (HR)|0.82||||0.3537|2-Sided|95.0|0.54|1.25|||Stratified log-rank test|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).|||
1628606|NCT02151149|2991536|Superiority||Hazard Ratio (HR)|0.52||||0.0036|2-Sided|95.0|0.33|0.81|||Stratified Log Rank|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).|||
1628607|NCT02151149|2991543|Superiority||Risk Ratio (RR)|1.01||||0.9258|2-Sided|95.0|0.84|1.21|||Cochran-Mantel-Haenszel|Based on stratification factors of ECOG PS at screening (0 vs. 1) and histology (squamous cell carcinoma vs. non-squamous cell carcinoma).|||
1628608|NCT02151058|2991555|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.0442|<|0.001|2-Sided|95.0|-0.2767|-0.1023||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628609|NCT02151058|2991555|Superiority or Other||Mean Difference (Final Values)|-0.464|Standard Error of the Mean|0.0548|<|0.001|2-Sided|95.0|-0.5724|-0.3565||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628610|NCT02151058|2991555|Superiority or Other||Mean Difference (Final Values)|-0.275|Standard Error of the Mean|0.0543|<|0.001|2-Sided|95.0|-0.382|-0.1679||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628611|NCT02151058|2991556|Superiority or Other||Mean Difference (Final Values)|-0.083|Standard Error of the Mean|0.0404||0.042|2-Sided|95.0|-0.1621|-0.0031||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628612|NCT02151058|2991556|Superiority or Other||Mean Difference (Final Values)|-0.313|Standard Error of the Mean|0.05|<|0.001|2-Sided|95.0|-0.4113|-0.2141||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628613|NCT02151058|2991556|Superiority or Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.0497|<|0.001|2-Sided|95.0|-0.3282|-0.1321||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628614|NCT02151058|2991557|Superiority or Other||Mean Difference (Final Values)|-0.044|Standard Error of the Mean|0.0301||0.145|2-Sided|95.0|-0.1034|0.0152||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628615|NCT02151058|2991557|Superiority or Other||Mean Difference (Final Values)|-0.168|Standard Error of the Mean|0.0373|<|0.001|2-Sided|95.0|-0.2413|-0.0941||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628616|NCT02151058|2991557|Superiority or Other||Mean Difference (Final Values)|-0.124|Standard Error of the Mean|0.0372|<|0.001|2-Sided|95.0|-0.197|-0.0504||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1630048|NCT02123511|2994076|Superiority|||||||0.5634|||||||t-test, 1 sided||||
1628617|NCT02151058|2991558|Superiority or Other||Mean Difference (Final Values)|-0.251|Standard Error of the Mean|0.0511|<|0.001|2-Sided|95.0|-0.3516|-0.1503||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628618|NCT02151058|2991558|Superiority or Other||Mean Difference (Final Values)|-0.498|Standard Error of the Mean|0.0638|<|0.001|2-Sided|95.0|-0.6236|-0.3722||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628619|NCT02151058|2991558|Superiority or Other||Mean Difference (Final Values)|-0.247|Standard Error of the Mean|0.0631|<|0.001|2-Sided|95.0|-0.3713|-0.1226||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||Treatment and baseline value as covariates.|
1628620|NCT02151058|2991559|Superiority or Other||Mean Difference (Final Values)|-0.174|Standard Error of the Mean|0.0458|<|0.001|2-Sided|95.0|-0.2648|-0.0841||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628621|NCT02151058|2991559|Superiority or Other||Mean Difference (Final Values)|-0.351|Standard Error of the Mean|0.0573|<|0.001|2-Sided|95.0|-0.4638|-0.2378||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628622|NCT02151058|2991559|Superiority or Other||Mean Difference (Final Values)|-0.176|Standard Error of the Mean|0.0568|<|0.002|2-Sided|95.0|-0.2882|-0.0644||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628623|NCT02151058|2991560|Superiority or Other||Mean Difference (Final Values)|-0.035|Standard Error of the Mean|0.0297||0.234|2-Sided|95.0|-0.094|0.0231||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628624|NCT02151058|2991560|Superiority or Other||Mean Difference (Final Values)|-0.118|Standard Error of the Mean|0.0372||0.002|2-Sided|95.0|-0.1917|-0.0451||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628625|NCT02151058|2991560|Superiority or Other||Mean Difference (Final Values)|-0.083|Standard Error of the Mean|0.0369||0.026|2-Sided|95.0|-0.1556|-0.0102||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628626|NCT02151058|2991561|Superiority or Other||Mean Difference (Final Values)|-0.172|Standard Error of the Mean|0.0786||0.03|2-Sided|95.0|-0.3268|-0.0168||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628627|NCT02151058|2991561|Superiority or Other||Mean Difference (Final Values)|-0.685|Standard Error of the Mean|0.0975|<|0.001|2-Sided|95.0|-0.877|-0.4925||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628628|NCT02151058|2991561|Superiority or Other||Mean Difference (Final Values)|-0.513|Standard Error of the Mean|0.0971|<|0.001|2-Sided|95.0|-0.7043|-0.3217||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628629|NCT02151058|2991562|Superiority or Other||Mean Difference (Final Values)|-0.042|Standard Error of the Mean|0.0653||0.52|2-Sided|95.0|-0.1709|0.0866||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628630|NCT02151058|2991562|Superiority or Other||Mean Difference (Final Values)|-0.328|Standard Error of the Mean|0.0811|<|0.001|2-Sided|95.0|-0.4877|-0.1679||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628631|NCT02151058|2991562|Superiority or Other||Mean Difference (Final Values)|-0.286|Standard Error of the Mean|0.0809|<|0.001|2-Sided|95.0|-0.445|-0.1263||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628632|NCT02151058|2991563|Superiority or Other||Mean Difference (Final Values)|-0.334|Standard Error of the Mean|0.0812|<|0.001|2-Sided|95.0|-0.4937|-0.1737||The significance threshold level was 0.05 (two-sided). Hypotheses were tested according to a hierarchical strategy.|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628633|NCT02151058|2991563|Superiority or Other||Mean Difference (Final Values)|-0.993|Standard Error of the Mean|0.1005|<|0.001|2-Sided|95.0|-1.1909|-0.7946||The significance threshold level was 0.05 (two-sided). Hypotheses were tested according to a hierarchical strategy.|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628688|NCT02148952|2991775|Superiority||Other|0.0|||<|0.001|2-Sided||||||Chi-squared, Corrected||The relative risk could not be calculated due to 100% or 0% values in one group.|Maternal temperature taken|
1628689|NCT02148952|2991775|Superiority||Risk Ratio (RR)|19.1|||<|0.001|2-Sided|95.0|7.9|46.5|||Chi-squared, Corrected|||Maternal blood pressure taken|
1628634|NCT02151058|2991563|Superiority or Other||Mean Difference (Final Values)|-0.659|Standard Error of the Mean|0.0999|<|0.001|2-Sided|95.0|-0.8559|-0.4622||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and baseline value as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1628635|NCT02150837|2991656|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Within group comparison (for each group) using a non-parametric paired Wilcoxon signed rank test comparing repeated measures in a single sample.|||
1628636|NCT02150057|2991696|Superiority||||||<|0.05|||||||ANOVA||||
1628637|NCT02149420|2991724|Superiority||Mean Difference (Final Values)|-0.93|Standard Deviation|2.058||0.678|2-Sided|95.0|-5.007|3.18|||repeated measures Bayesian analysis|with baseline as a covariate||Per protocol the primary analysis was between placebo and the combined VAY736 groups at Week 12.|
1628638|NCT02149199|2991743|Superiority||Rate ratio|0.95||||0.663|2-Sided|95.0|0.74|1.21|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of moderate or severe exacerbations in the Symbicort 'as needed' treatment group.||
1628639|NCT02149199|2991743|Superiority||Rate ratio|0.4|||<|0.001|2-Sided|95.0|0.32|0.49|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of moderate or severe exacerbations in the Symbicort 'as needed' treatment group.||
1628640|NCT02149199|2991744|Superiority||Rate ratio|0.83||||0.279|2-Sided|95.0|0.59|1.16|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of severe exacerbations in the Symbicort 'as needed' treatment group.||
1628641|NCT02149199|2991744|Superiority||Rate ratio|0.36|||<|0.001|2-Sided|95.0|0.27|0.49|||Negative binomial model|Negative binomial model with treatment, pre-study treatment, severe exacerbations in the last 12 months (0,>=1) and region as covariates|A rate ratio less than 1 indicates a lower rate of severe exacerbations in the Symbicort 'as needed' treatment group.||
1628642|NCT02149199|2991746|Superiority||Mean Difference (Net)|-0.102|||<|0.001|2-Sided|95.0|-0.155|-0.049|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and treatment x visit as fixed, patient as random and baseline AQLQ(S) as continuous covariate|Mean difference greater than 0 favours Symbicort 'as needed'.||
1628643|NCT02149199|2991746|Superiority||Mean Difference (Net)|0.127|||<|0.001|2-Sided|95.0|0.074|0.181|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and treatment x visit as fixed, patient as random and baseline AQLQ(S) as continuous covariate|Mean difference greater than 0 favours Symbicort 'as needed'.||
1628644|NCT02149199|2991747|Superiority||Mean Difference (Net)|0.149|||<|0.001|2-Sided|95.0|0.101|0.198|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline ACQ-5 as continuous covariate|Mean difference less than 0 favours Symbicort 'as needed'.||
1628645|NCT02149199|2991747|Superiority||Mean Difference (Net)|-0.154|||<|0.001|2-Sided|95.0|-0.203|-0.105|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline ACQ-5 as continuous covariate|Mean difference less than 0 favours Symbicort 'as needed'.||
1628646|NCT02149199|2991748|Superiority||Hazard Ratio (HR)|0.865||||0.175|2-Sided|95.0|0.701|1.067|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first additional steroids.||
1628647|NCT02149199|2991748|Superiority||Hazard Ratio (HR)|0.413|||<|0.001|2-Sided|95.0|0.343|0.497|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first additional steroids.||
1628648|NCT02149199|2991755|Superiority||Mean Difference (Net)|0.09||||0.004|2-Sided|95.0|0.03|0.15|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline asthma symptom score as a continuous covariate.|Mean difference less than 0 favours Symbicort 'as needed'.||
1628649|NCT02149199|2991755|Superiority||Mean Difference (Net)|-0.12|||<|0.001|2-Sided|95.0|-0.18|-0.06|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline asthma symptom score as a continuous covariate.|Mean difference less than 0 favours Symbicort 'as needed'.||
1628650|NCT02149199|2991757|Superiority||Mean Difference (Net)|-6.23||||0.002|2-Sided|95.0|-10.18|-2.29|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.||
1628651|NCT02149199|2991757|Superiority||Mean Difference (Net)|10.94|||<|0.001|2-Sided|95.0|6.99|14.9|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.||
1628652|NCT02149199|2991758|Superiority||Mean Difference (Net)|-9.98|||<|0.001|2-Sided|95.0|-14.03|-5.93|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.||
1628653|NCT02149199|2991758|Superiority||Mean Difference (Net)|11.95|||<|0.001|2-Sided|95.0|7.89|16.0|||ANCOVA|ANCOVA model with randomised treatment, pre-study treatment and region as factors and baseline PEF as a continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'.||
1628654|NCT02149199|2991759|Superiority||Mean Difference (Net)|-54.3|||<|0.001|2-Sided|95.0|-78.8|-29.8|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline FEV1 as continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. This is the estimate across all treatment visits.||
1628655|NCT02149199|2991759|Superiority||Mean Difference (Net)|53.8|||<|0.001|2-Sided|95.0|29.1|78.5|||Mixed Models Analysis|MMRM with treatment, pre-study treatment, region, visit and (treatment x visit) as fixed, patient as random and baseline FEV1 as continuous covariate.|Mean difference greater than 0 favours Symbicort 'as needed'. This is the estimate across all treatment visits.||
1628882|NCT02145156|2992161|Superiority or Other|||||||0.98|||||||Fisher Exact||||
1628656|NCT02149199|2991760|Superiority||Hazard Ratio (HR)|0.91||||0.436|2-Sided|95.0|0.718|1.153|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first moderate or severe exacerbation.||
1628657|NCT02149199|2991760|Superiority||Hazard Ratio (HR)|0.429|||<|0.001|2-Sided|95.0|0.348|0.528|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first moderate or severe exacerbation.||
1628658|NCT02149199|2991761|Superiority||Hazard Ratio (HR)|0.901||||0.524|2-Sided|95.0|0.653|1.242|||Regression, Cox|Cox regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0,>=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.||
1628659|NCT02149199|2991761|Superiority||Hazard Ratio (HR)|0.435|||<|0.001|2-Sided|95.0|0.328|0.577|||Regression, Cox|Cox-regression model with randomised treatment, pre-study treatment, severe exacerbations in the last 12 months (0, >=1) and region as covariates.|A hazard ratio less than 1 indicates that Symbicort 'as needed' prolongs the time to first severe exacerbation.||
1628660|NCT02149199|2991762|Non-Inferiority|Non-inferiority analysis based on CI instead of p-value, hence no p-value calculated for this analysis. Lower limit of the 2-sided 95% CI >=0.8 indicates Symbicort 'as needed' is non-inferior to Pulmicort bid.|Odds Ratio (OR)|0.64|||||2-Sided|95.0|0.57|0.73|||||||
1628661|NCT02149199|2991762|Superiority||Odds Ratio (OR)|1.14||||0.046|2-Sided|95.0|1.0|1.3|||Regression, Logistic|Repeated measures logistic regression, with treatment, pre-study treatment, region and study week as fixed effects.|An odds ratio greater than 1 favours Symbicort 'as needed'||
1628662|NCT02149108|2991767|Superiority or Other||Odds Ratio (OR)|2.96|||<|0.0001|2-Sided|95.0|2.0|4.47||Odds ratio and p−value are obtained from logistic regression model adjusted for regorafenib pre−treatment (yes vs no), time from onset metastatic disease until randomization in the trial (less than 24 months vs. 24 months or more) and region.|Regression, Logistic||An odds ratio >1 indicates benefit to Nintedanib.||
1628663|NCT02149108|2991769|Superiority or Other||Hazard Ratio (HR)|1.01||||0.8659|2-Sided|95.0|0.86|1.19||Hazard ratio, confidence interval and p−value obtained from log−rank test stratified by regorafenib pre−treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.|Log Rank||Hazard ratio below 1 favors Nintedanib.||
1628664|NCT02149108|2991770|Superiority or Other||Hazard Ratio (HR)|0.58|||<|0.0001|2-Sided|95.0|0.49|0.69||Hazard ratio, confidence interval and p−value obtained from log−rank test stratified by regorafenib pre−treatment (yes vs no), time from onset metastatic disease until randomisation (less than 24 months vs 24 months or more ) and region.|Log Rank||Hazard ratio <1 favors Nintedanib.||
1628665|NCT02148952|2991771|Superiority||Risk Ratio (RR)|1.1||||0.95|2-Sided|95.0|0.2|6.6|||Chi-squared, Corrected|||Mother given magnesium sulfate|
1628666|NCT02148952|2991771|Superiority||Risk Ratio (RR)|12.7|||<|0.001|2-Sided|95.0|4.7|34.3|||Chi-squared, Corrected|||Maternal blood pressure taken|
1628667|NCT02148952|2991771|Superiority||Other|0.0|||<|0.001|2-Sided||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Maternal temperature taken|
1628668|NCT02148952|2991772|Superiority||Other|0.0|||<|0.001|2-Sided||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use|
1628669|NCT02148952|2991772|Superiority||Risk Ratio (RR)|7.9|||<|0.001|2-Sided|95.0|3.7|16.7|||Chi-squared, Corrected|||Initiation of breast-feeding|
1628670|NCT02148952|2991772|Superiority||Other|0.0|||<|0.01|2-Sided||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Skin-to-skin care maintained for 1 hr|
1628671|NCT02148952|2991772|Superiority||Risk Ratio (RR)|8.2|||<|0.001|2-Sided|95.0|2.5|27.5|||Chi-squared, Corrected|||Skin-to-skin care initiated at birth|
1628672|NCT02148952|2991772|Superiority||Risk Ratio (RR)|91.5|||<|0.001|2-Sided|95.0|11.0|758.0|||Chi-squared, Corrected|||Newborn temperature taken|
1628673|NCT02148952|2991772|Superiority||Risk Ratio (RR)|1.1|||<|0.08|2-Sided|95.0|1.0|1.3|||Chi-squared, Corrected|||Newborn weight taken|
1628674|NCT02148952|2991773|Superiority||Risk Ratio (RR)|1.0||||0.5|2-Sided|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth companion present|
1628675|NCT02148952|2991773|Superiority||Risk Ratio (RR)|0.6||||0.19|2-Sided|95.0|0.3|1.3|||Chi-squared, Corrected|||Neonatal bag used|
1628676|NCT02148952|2991773|Superiority||Risk Ratio (RR)|3.6|||<|0.001|2-Sided|95.0|1.8|7.5|||Chi-squared, Corrected|||Oxytocin administered|
1628677|NCT02148952|2991774|Superiority||Risk Ratio (RR)|37.9|||<|0.001|2-Sided|95.0|7.3|196.0|||Chi-squared, Corrected|||Checklist available|
1628678|NCT02148952|2991774|Superiority||Risk Ratio (RR)|1.4|||<|0.11|2-Sided|95.0|0.9|2.1|||Chi-squared, Corrected|||Pads available|
1628679|NCT02148952|2991774|Superiority||Risk Ratio (RR)|1.0|||<|0.32|2-Sided|95.0|1.0|1.0|||Chi-squared, Corrected|||Neonatal bag and mask available|
1628680|NCT02148952|2991774|Superiority||Risk Ratio (RR)|1.0|||<|0.5|2-Sided|95.0|1.0|1.1|||Chi-squared, Corrected|||Mucus extractor available|
1628681|NCT02148952|2991774|Superiority||Risk Ratio (RR)|1.0|||<|0.25|2-Sided|95.0|1.0|1.0|||Chi-squared, Corrected|||Cord tie available|
1628682|NCT02148952|2991774|Superiority||Risk Ratio (RR)|1.0|||<|0.34|2-Sided|95.0|1.0|1.1|||Chi-squared, Corrected|||Clean scissors or blade available|
1628683|NCT02148952|2991774|Superiority||Risk Ratio (RR)|2.4|||<|0.006|2-Sided|95.0|1.3|4.3|||Chi-squared, Corrected|||Clean towel available|
1628684|NCT02148952|2991774|Superiority||Risk Ratio (RR)|2.1|||<|0.04|2-Sided|95.0|1.0|4.1|||Chi-squared, Corrected|||No oxytocin given before delivery|
1628685|NCT02148952|2991774|Superiority||Risk Ratio (RR)|19.9|||<|0.001|2-Sided|95.0|6.6|60.4|||Chi-squared, Corrected|||Hand hygiene|
1628686|NCT02148952|2991775|Superiority||Other|0.0|||<|0.001|2-Sided||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use|
1628690|NCT02148952|2991775|Superiority||Risk Ratio (RR)|1.0|||<|1|2-Sided|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth companion present|
1628691|NCT02148952|2991776|Superiority||Other|0.0|||<|0.001|2-Sided||||||Chi-squared, Corrected||||
1628692|NCT02148952|2991777|Superiority||Risk Ratio (RR)|0.4||||0.3|2-Sided|95.0|0.1|2.1|||Chi-squared, Corrected|||Mother given magnesium sulfate|
1628693|NCT02148952|2991777|Superiority||Risk Ratio (RR)|9.9|||<|0.001|2-Sided|95.0|3.8|25.8|||Chi-squared, Corrected|||Maternal blood pressure taken|
1628694|NCT02148952|2991777|Superiority||Risk Ratio (RR)|182.0|||<|0.001|2-Sided|95.0|33.5|993.0|||Chi-squared, Corrected|||Maternal temperature taken|
1628695|NCT02148952|2991778|Superiority||Other|0.0|||<|0.001|2-Sided||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Checklist use|
1628696|NCT02148952|2991778|Superiority||Risk Ratio (RR)|19.4|||<|0.001|2-Sided|95.0|11.4|33.2|||Chi-squared, Corrected|||Initiation of breast-feeding|
1628697|NCT02148952|2991778|Superiority||Risk Ratio (RR)|38.7|||<|0.001|2-Sided|95.0|7.7|194.0|||Chi-squared, Corrected|||Skin-to-skin care maintained for 1 hr|
1628698|NCT02148952|2991778|Superiority||Risk Ratio (RR)|7.3|||<|0.001|2-Sided|95.0|2.4|22.0|||Chi-squared, Corrected|||Skin-to-skin care initiated at birth|
1628699|NCT02148952|2991778|Superiority||Risk Ratio (RR)|317.0|||<|0.001|2-Sided|95.0|50.4|1989.0|||Chi-squared, Corrected|||Newborn temperature taken|
1628700|NCT02148952|2991778|Superiority||Risk Ratio (RR)|1.1|||<|0.25|2-Sided|95.0|0.9|1.4|||Chi-squared, Corrected|||Newborn weight taken|
1628701|NCT02148952|2991779|Superiority||Risk Ratio (RR)|1.0||||0.25|2-Sided|95.0|1.0|1.0|||Chi-squared, Corrected|||Birth attendant present|
1628702|NCT02148952|2991779|Superiority||Risk Ratio (RR)|0.6||||0.25|2-Sided|95.0|0.3|1.4|||Chi-squared, Corrected|||Neonatal bag used|
1628703|NCT02148952|2991779|Superiority||Risk Ratio (RR)|3.9|||<|0.001|2-Sided|95.0|2.1|7.2|||Chi-squared, Corrected|||Oxytocin administered|
1628704|NCT02148952|2991780|Superiority||Risk Ratio (RR)|185.0|||<|0.001|2-Sided|95.0|19.7|1738.0|||Chi-squared, Corrected|||Checklist use|
1628705|NCT02148952|2991780|Superiority||Risk Ratio (RR)|2.1|||<|0.005|2-Sided|95.0|1.3|3.5|||Chi-squared, Corrected|||Pads available|
1628706|NCT02148952|2991780|Superiority||Risk Ratio (RR)|1.0|||<|0.56|2-Sided|95.0|0.9|1.1|||Chi-squared, Corrected|||Neonatal bag and mask available|
1628707|NCT02148952|2991780|Superiority||Risk Ratio (RR)|1.0|||<|0.73|2-Sided|95.0|0.9|1.1|||Chi-squared, Corrected|||Mucus extractor available|
1628708|NCT02148952|2991780|Superiority||Risk Ratio (RR)|1.0|||<|0.48|2-Sided|95.0|1.0|1.0|||Chi-squared, Corrected|||Cord tie available|
1628709|NCT02148952|2991780|Superiority||Risk Ratio (RR)|1.1|||<|0.72|2-Sided|95.0|0.7|1.7|||Chi-squared, Corrected|||Clean scissors or blade available|
1628710|NCT02148952|2991780|Superiority||Risk Ratio (RR)|5.7|||<|0.001|2-Sided|95.0|2.7|12.1|||Chi-squared, Corrected|||Clean towel available|
1628711|NCT02148952|2991780|Superiority||Risk Ratio (RR)|2.3|||<|0.007|2-Sided|95.0|1.3|4.2|||Chi-squared, Corrected|||No oxytocin given before delivery|
1628712|NCT02148952|2991780|Superiority||Risk Ratio (RR)|53.3|||<|0.001|2-Sided|95.0|13.1|217.0|||Chi-squared, Corrected|||Hand hygiene|
1628713|NCT02148952|2991781|Superiority||Risk Ratio (RR)|413.0|||<|0.001|2-Sided|95.0|65.8|2589.0|||Chi-squared, Corrected|||Checklist use|
1628714|NCT02148952|2991781|Superiority||Risk Ratio (RR)|7.3|||<|0.01|2-Sided|95.0|1.5|35.6|||Chi-squared, Corrected|||Partography started|
1628715|NCT02148952|2991781|Superiority||Risk Ratio (RR)|132.0|||<|0.001|2-Sided|95.0|26.9|645.0|||Chi-squared, Corrected|||Maternal temperature taken|
1628716|NCT02148952|2991781|Superiority||Risk Ratio (RR)|9.8|||<|0.001|2-Sided|95.0|3.4|28.3|||Chi-squared, Corrected|||Maternal blood pressure taken|
1628717|NCT02148952|2991781|Superiority||Other|0.0|||<|0.18|2-Sided||||||Chi-squared, Corrected||The relative risk could not be calculated owing to 100% or 0% values in one group.|Birth Companion Present|
1628718|NCT02148952|2991782|Superiority||Other|0.0|||<|0.001|2-Sided||||||Chi-squared, Corrected||||
1628719|NCT02148952|2991783|Superiority||Risk Ratio (RR)|0.92||||0.3|2-Sided|95.0|0.78|1.08|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.||
1628720|NCT02148952|2991784|Superiority||Risk Ratio (RR)|0.91||||0.32|2-Sided|95.0|0.76|1.1|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.||
1628721|NCT02148952|2991785|Superiority||Risk Ratio (RR)|0.99||||0.97|2-Sided|95.0|0.69|1.43|||Chi-squared, Corrected||||
1628722|NCT02148952|2991786|Superiority||Risk Ratio (RR)|1.0||||0.95|2-Sided|95.0|0.45|2.13|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.||
1628723|NCT02148952|2991787|Superiority||Risk Ratio (RR)|1.19||||0.41|2-Sided|95.0|0.78|1.8|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.||
1628724|NCT02148952|2991788|Superiority||Risk Ratio (RR)|1.09||||0.57|2-Sided|95.0|0.81|1.47|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.||
1628725|NCT02148952|2991789|Superiority||Risk Ratio (RR)|1.07||||0.74|2-Sided|95.0|0.72|1.58|||Chi-squared, Corrected||||
1628726|NCT02148952|2991790|Superiority||Risk Ratio (RR)|0.5||||0.41|2-Sided|95.0|0.34|1.58|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of stroke|
1628883|NCT02145156|2992161|Superiority or Other|||||||0.15|||||||Fisher Exact||||
1628884|NCT02145156|2992161|Superiority or Other|||||||0.16|||||||Fisher Exact||||
1628727|NCT02148952|2991790|Superiority||Risk Ratio (RR)|0.95||||0.61|2-Sided|95.0|0.77|1.17|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of hemorrhage|
1628728|NCT02148952|2991790|Superiority||Risk Ratio (RR)|1.02||||0.9|2-Sided|95.0|0.76|1.38|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of high fever with foul-smelling vaginal discharge|
1628729|NCT02148952|2991790|Superiority||Risk Ratio (RR)|0.98||||0.97|2-Sided|95.0|0.7|1.41|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of loss of consciousness for > 1 hr|
1628730|NCT02148952|2991790|Superiority||Risk Ratio (RR)|0.89||||0.76|2-Sided|95.0|0.57|1.52|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate of seizures|
1628731|NCT02148952|2991790|Superiority||Risk Ratio (RR)|0.97||||0.81|2-Sided|95.0|0.79|1.2|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.|Rate any severe maternal complication within 7 days|
1628732|NCT02148952|2991791|Superiority||Risk Ratio (RR)|1.11||||0.73|2-Sided|95.0|0.74|1.53|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.||
1628733|NCT02148952|2991792|Superiority||Risk Ratio (RR)|1.1||||0.19|2-Sided|95.0|0.95|1.27|||Chi-squared, Corrected||||
1628734|NCT02148952|2991793|Superiority||Risk Ratio (RR)|0.94||||0.56|2-Sided|95.0|0.76|1.16|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.||
1628735|NCT02148952|2991794|Superiority||Risk Ratio (RR)|1.03||||0.68|2-Sided|95.0|0.89|1.2|||Chi-squared, Corrected||||
1628736|NCT02148952|2991795|Superiority||Risk Ratio (RR)|1.03||||0.67|2-Sided|95.0|0.89|1.2|||Chi-squared, Corrected||Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.||
1628737|NCT02148952|2991796|Superiority|We hypothesized a 15% reduction in the composite outcome between the intervention and control arm.|Risk Ratio (RR)|0.99||||0.9|2-Sided|95.0|0.83|1.18|||Chi-squared, Corrected|In secondary analyses, a Rao-Scott test with 3 degrees of freedom resulted in a p value of 0.88.|Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.||
1628738|NCT02148874|2991797|Superiority||Odds Ratio (OR)|0.74||||0.25|2-Sided|95.0|0.44|1.24|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Brisbane|
1628739|NCT02148874|2991797|Superiority||Odds Ratio (OR)|1.47||||0.14|2-Sided|95.0|0.88|2.46|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Massachusetts|
1628740|NCT02148874|2991797|Superiority||Odds Ratio (OR)|0.89||||0.67|2-Sided|95.0|0.53|1.5|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2|
1628741|NCT02148874|2991797|Superiority||Odds Ratio (OR)|0.89||||0.64|2-Sided|95.0|0.53|1.48|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1|
1628742|NCT02148874|2991798|Superiority||Odds Ratio (OR)|1.63||||0.13|2-Sided|95.0|0.87|3.04|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Brisbane|
1628743|NCT02148874|2991798|Superiority||Odds Ratio (OR)|1.89||||0.04|2-Sided|95.0|1.04|3.44|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain B/Massachusetts|
1628744|NCT02148874|2991798|Superiority||Odds Ratio (OR)|1.09||||0.74|2-Sided|95.0|0.66|1.8|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2|
1628745|NCT02148874|2991798|Superiority||Odds Ratio (OR)|1.39||||0.2|2-Sided|95.0|0.84|2.32|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1|
1628746|NCT02148874|2991799|Superiority||Odds Ratio (OR)|1.08||||0.77|2-Sided|95.0|0.63|1.87|||Regression, Logistic||Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/ N).|Statistical analysis for influenza strain B/Brisbane|
1628885|NCT02145156|2992162|Superiority or Other|||||||0.34|||||||Fisher Exact||||
1628886|NCT02145156|2992162|Superiority or Other|||||||0.71|||||||Fisher Exact||||
1628747|NCT02148874|2991799|Superiority||Odds Ratio (OR)|1.26||||0.43|2-Sided|95.0|0.71|2.24|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/ N).|Statistical analysis for influenza strain B/Massachusetts|
1628748|NCT02148874|2991799|Superiority||Odds Ratio (OR)|1.07||||0.79|2-Sided|95.0|0.65|1.75|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H3N2|
1628749|NCT02148874|2991799|Superiority||Odds Ratio (OR)|1.05||||0.84|2-Sided|95.0|0.64|1.73|||Regression, Logistic|Cumulative logistic regression model|Cumulative logistic regression model, OR for obese vs. non-obese. Model adjusted for mother's age, parity, gestational age at vaccination, vaccination season, and prior year vaccination (Y/N).|Statistical analysis for influenza strain A/H1N1.|
1628750|NCT02148445|2991830|Superiority|||||||0.0918|||||||Mixed Models Analysis||||
1628751|NCT02148445|2991831|Superiority|||||||0.77|||||||Mixed Models Analysis||||
1628752|NCT02148445|2991832|Superiority|||||||0.08|||||||Mixed Models Analysis||||
1628753|NCT02148445|2991833|Superiority|||||||0.05|||||||Mixed Models Analysis||||
1628754|NCT02148445|2991834|Superiority|||||||0.0149|||||||Mixed Models Analysis||||
1628755|NCT02148445|2991835|Superiority|||||||0.66|||||||Chi-squared|||Month 12, self-reported abstinence|
1628756|NCT02148445|2991835|Superiority|||||||0.34|||||||Chi-squared|||Month 6, biochemically verified abstinence|
1628757|NCT02148445|2991835|Superiority|||||||0.22|||||||Chi-squared|||Month 6, self-reported abstinence|
1628758|NCT02148445|2991835|Superiority|||||||0.06|||||||Chi-squared|||Month 3 biochemically verified abstinence|
1628759|NCT02148445|2991835|Superiority|||||||0.08|||||||Chi-squared|||Month 3 self-reported abstinence|
1628760|NCT02148445|2991837|Superiority|||||||0.06|||||||Mixed Models Analysis||||
1628761|NCT02148445|2991838|Superiority|||||||0.27|||||||Mixed Models Analysis||||
1628762|NCT02148445|2991839|Superiority|||||||0.42|||||||t-test, 1 sided||||
1628763|NCT02148445|2991840|Superiority|||||||0.39|||||||Mixed Models Analysis||||
1628764|NCT02148445|2991841|Superiority|||||||0.05|||||||Mixed Models Analysis||||
1628765|NCT02148445|2991842|Superiority|||||||0.05|||||||Mixed Models Analysis||||
1628766|NCT02148445|2991843|Superiority|||||||0.4|||||||Mixed Models Analysis||||
1628767|NCT02148445|2991844|Superiority|Based on prior studies using precessation NRT, we estimate a 2-fold increase in cessation outcomes in the GMT group compared to the SC group. Given our recruitment of patients at all levels of readiness to quit, we estimate a 12 month cessation rate of 10%. With 199 participants, in each arm, we will have an 80% power to detect a 2-fold difference or greater with a Type I error rate of 5%. This sample size will provide comparable power for looking at 6 month sustained cessation.||||||0.55|||||||Chi-squared||||
1628768|NCT02148445|2991845|Superiority|Based on prior studies using precessation NRT, we estimate a 2-fold increase in cessation outcomes in the GMT group compared to the SC group. Given our recruitment of patients at all levels of readiness to quit, we estimate a 12 month cessation rate of 10%. With 199 participants, in each arm, we will have an 80% power to detect a 2-fold difference or greater with a Type I error rate of 5%.||||||0.88|||||||Chi-squared||||
1628769|NCT02147587|2991912|Superiority or Other||Difference in percentages|2.65|||||2-Sided|80.0|-10.66|15.83||||||Tofacitinib versus Placebo (Week 12)|
1628770|NCT02147587|2991912|Superiority or Other||Difference in percentages|14.01|||||2-Sided|80.0|1.57|26.03||||||Tofacitinib versus Placebo (Week 4)|
1628771|NCT02147587|2991912|Superiority or Other||Difference in percentages|8.39|||||2-Sided|80.0|-4.05|20.56||||||Tofacitinib versus Placebo (Day 1)|
1628772|NCT02147587|2991913|Superiority or Other||Ratio of GMT|1.121|||||2-Sided|80.0|0.862|1.459|||||Ratio of GMTs (Tofacitinib/Placebo) at Week 12|GMT for Tofacitinib versus Placebo (Week 12)|
1628773|NCT02147587|2991913|Superiority or Other||Ratio of GMT|1.251|||||2-Sided|80.0|0.967|1.618|||||Ratio of GMTs (Tofacitinib/Placebo) at Week 4|GMT for Tofacitinib versus Placebo (Week 4)|
1628774|NCT02147587|2991913|Superiority or Other||Ratio of GMT|1.063|||||2-Sided|80.0|0.821|1.375|||||Ratio of GMTs (Tofacitinib/Placebo) at Day 1|Geometric Mean Titer (GMT) for Tofacitinib versus Placebo (Day 1)|
1628775|NCT02147587|2991914|Superiority or Other||Ratio of GMFR|1.093|||||2-Sided|80.0|0.924|1.294|||||Ratio of GMFRs (Tofacitinib/Placebo) at Week 12|GMFR for Tofacitinib versus Placebo (Week 12)|
1628776|NCT02147587|2991914|Superiority or Other||Ratio of GMFR|1.03|||||2-Sided|80.0|0.877|1.209|||||Ratio of GMFRs (Tofacitinib/Placebo) at Day 1|GMFR for Tofacitinib versus Placebo (Day 1)|
1628777|NCT02147587|2991915|Superiority or Other||Ratio of GMFR|1.213|||||2-Sided|80.0|1.033|1.424|||||Ratio of GMFRs (Tofacitinib/Placebo) at Week 4|Geometric Mean Fold Rise (GMFR) for Tofacitinib versus Placebo (Week 4)|
1628778|NCT02146326|2992016|Superiority|||||||0.45|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628779|NCT02146326|2992017|Superiority|||||||0.14|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628780|NCT02146326|2992018|Superiority|||||||0.84|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628781|NCT02146326|2992019|Superiority|||||||0.06|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628887|NCT02145156|2992162|Superiority or Other|||||||0.52|||||||Fisher Exact||||
1628888|NCT02145156|2992162|Superiority or Other|||||||0.59|||||||Fisher Exact||||
1628782|NCT02146326|2992020|Superiority|||||||0.05|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628783|NCT02146326|2992021|Superiority|||||||0.64|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628784|NCT02146326|2992022|Superiority|||||||0.59|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628785|NCT02146326|2992023|Superiority|||||||0.77|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628786|NCT02146326|2992024|Superiority|||||||0.67|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628787|NCT02146326|2992025|Superiority|||||||0.48|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628788|NCT02146326|2992026|Superiority|||||||0.91|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628789|NCT02146326|2992027|Superiority|||||||0.55|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628790|NCT02146326|2992028|Superiority|||||||0.14|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628791|NCT02146326|2992029|Superiority|||||||0.11|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628792|NCT02146326|2992030|Superiority|||||||0.22|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628793|NCT02146326|2992031|Superiority|||||||0.71|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628794|NCT02146326|2992032|Superiority|||||||0.34|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628795|NCT02146326|2992033|Superiority|||||||0.04|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628796|NCT02146326|2992034|Superiority|||||||0.67|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628797|NCT02146326|2992035|Superiority|||||||0.35|||||||Chi-squared||||
1628798|NCT02146326|2992036|Superiority|||||||0.24|||||||Mixed Models Analysis||||
1628799|NCT02146326|2992037|Superiority|||||||0.17|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628800|NCT02146326|2992039|Superiority|||||||0.21|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628801|NCT02146326|2992040|Superiority|||||||0.11|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628802|NCT02146326|2992041|Superiority|||||||0.93|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628803|NCT02146326|2992042|Superiority|||||||0.13|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628804|NCT02146326|2992043|Superiority|||||||0.37|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628889|NCT02145156|2992163|Superiority or Other|||||||0.7|||||||Fisher Exact||||
1628890|NCT02145156|2992163|Superiority or Other|||||||0.25|||||||Fisher Exact||||
1628805|NCT02146326|2992044|Superiority|||||||0.64|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628806|NCT02146326|2992045|Superiority|||||||0.83|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628807|NCT02146326|2992046|Superiority|||||||0.37|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628808|NCT02146326|2992047|Superiority|||||||0.6|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628809|NCT02146326|2992048|Superiority|||||||0.47|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628810|NCT02146326|2992049|Superiority|||||||0.17|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628811|NCT02146326|2992050|Superiority|||||||0.96|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628812|NCT02146326|2992051|Superiority|||||||0.94|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628813|NCT02146326|2992052|Superiority|||||||0.54|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628814|NCT02146326|2992053|Superiority|||||||0.8|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628815|NCT02146326|2992054|Superiority|||||||0.8|||||||Mixed Models Analysis|||Mixed effects regression analysis was used to examine the BREATHE intervention effect on clinician burnout and patient processes, engagement, and outcomes as compared to MI after the intervention by adjusting for the baseline scores and the implementation site.|
1628816|NCT02146248|2992061|Superiority or Other|||||||0.4795||||||The two-tailed P value equals 0.4795|McNemar|||McNemar paired. Hypothesis is no change in tubal patency status. All subjects know to have bilateral patency in one of the exams during natural cycle|
1628817|NCT02145468|2992082|Superiority||Hazard Ratio (HR)|1.11||||0.581|2-Sided|95.0|0.77|1.59|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Any unplanned coronary revascularization, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628818|NCT02145468|2992083|Superiority||Hazard Ratio (HR)|0.94||||0.736|2-Sided|95.0|0.63|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 24|
1628819|NCT02145468|2992083|Superiority||Hazard Ratio (HR)|0.84||||0.457|2-Sided|95.0|0.54|1.32|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628820|NCT02145468|2992084|Superiority||Hazard Ratio (HR)|0.95||||0.883|2-Sided|95.0|0.46|1.96|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Stroke (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628821|NCT02145468|2992085|Superiority||Hazard Ratio (HR)|1.14||||0.697|2-Sided|95.0|0.58|2.24|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|SRI-UR events, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628822|NCT02145468|2992086|Superiority||Hazard Ratio (HR)|1.34||||0.21|2-Sided|95.0|0.85|2.12|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Type I (spontaneous) MI events, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628823|NCT02145468|2992087|Superiority||Hazard Ratio (HR)|1.21||||0.158|2-Sided|95.0|0.93|1.58|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Myocardial infarction (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 24|
1628891|NCT02145156|2992163|Superiority or Other|||||||0.23|||||||Fisher Exact||||
1628892|NCT02145156|2992163|Superiority or Other|||||||0.37|||||||Fisher Exact||||
1628824|NCT02145468|2992087|Superiority||Hazard Ratio (HR)|1.23||||0.182|2-Sided|95.0|0.91|1.67|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Myocardial infarction (fatal and non-fatal) events, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628825|NCT02145468|2992088|Superiority||Hazard Ratio (HR)|0.76||||0.251|2-Sided|95.0|0.47|1.22|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|CHD death events, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628826|NCT02145468|2992089|Superiority||Hazard Ratio (HR)|0.8||||0.264|2-Sided|95.0|0.55|1.18|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|CV death events, Placebo Vs Losmapimod 7.5 mg BID at Week 24|
1628827|NCT02145468|2992089|Superiority||Hazard Ratio (HR)|0.83||||0.398|2-Sided|95.0|0.53|1.28|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|CV death events, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628828|NCT02145468|2992090|Superiority||Hazard Ratio (HR)|0.8||||0.309|2-Sided|95.0|0.53|1.22|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Participants with all-cause mortality, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628829|NCT02145468|2992091|Superiority||Odds Ratio (OR)|1.03||||0.744|2-Sided|95.0|0.84|1.27|||Wald chi-squared||Odds ratio is estimated using a logistic regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. An odds ratio <1 indicates a lower risk with the treatment compared with placebo.||
1628830|NCT02145468|2992092|Superiority||Hazard Ratio (HR)|0.57||||0.13|2-Sided|95.0|0.27|1.19|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Participants with first occurrence of definite or probable stent thrombosis, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628831|NCT02145468|2992093|Superiority||Hazard Ratio (HR)|1.07||||0.664|2-Sided|95.0|0.78|1.48|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or type I (spontaneous) MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628832|NCT02145468|2992094|Superiority||Hazard Ratio (HR)|1.11||||0.469|2-Sided|95.0|0.83|1.49|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, type I (spontaneous) MI or SRI-UR, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628833|NCT02145468|2992095|Superiority||Hazard Ratio (HR)|1.11||||0.412|2-Sided|95.0|0.86|1.43|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Composite of all-cause death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628834|NCT02145468|2992096|Superiority||Hazard Ratio (HR)|1.14||||0.295|2-Sided|95.0|0.89|1.44|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Composite of all-cause death, MI or SRI-UR,Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628835|NCT02145468|2992097|Superiority||Hazard Ratio (HR)|1.12||||0.401|2-Sided|95.0|0.86|1.46|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Composite of CHD death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628836|NCT02145468|2992098|Superiority||Hazard Ratio (HR)|1.14||||0.285|2-Sided|95.0|0.89|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Composite of CHD death, MI or SRI-UR, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628837|NCT02145468|2992099|Superiority||Hazard Ratio (HR)|1.11||||0.329|2-Sided|95.0|0.9|1.39|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, MI, SRI-UR, stroke or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628838|NCT02145468|2992100|Superiority||Hazard Ratio (HR)|1.12||||0.356|2-Sided|95.0|0.88|1.43|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death, MI or stroke, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628839|NCT02145468|2992101|Superiority||Hazard Ratio (HR)|0.92||||0.6|2-Sided|95.0|0.69|1.24|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 24|
1628893|NCT02145156|2992164|Superiority or Other|||||||0.23|||||||Fisher Exact||||
1628894|NCT02145156|2992164|Superiority or Other|||||||0.23|||||||Fisher Exact||||
1628895|NCT02145156|2992164|Superiority or Other|||||||1|||||||Fisher Exact||||
1628840|NCT02145468|2992101|Superiority||Hazard Ratio (HR)|0.9||||0.536|2-Sided|95.0|0.64|1.26|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Composite of CV death or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628841|NCT02145468|2992102|Superiority||Hazard Ratio (HR)|1.08||||0.505|2-Sided|95.0|0.86|1.36|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Composite of coronary events (CHD death, MI, SRI-UR or any unplanned coronary artery revascularization), Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628842|NCT02145468|2992103|Superiority||Hazard Ratio (HR)|1.14|||||2-Sided|95.0|0.91|1.44|||||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|Composite of arterial CV events (CV death, MI, SRI-UR or stroke), Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628843|NCT02145468|2992104|Superiority||Hazard Ratio (HR)|1.09||||0.472|2-Sided|95.0|0.86|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|CV death, MI or hospitalization for HF, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628844|NCT02145468|2992105|Superiority||Hazard Ratio (HR)|1.1||||0.41|2-Sided|95.0|0.88|1.38|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|CV death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 24|
1628845|NCT02145468|2992105|Superiority||Hazard Ratio (HR)|1.13||||0.338|2-Sided|95.0|0.88|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.|CV death or MI, Placebo Vs Losmapimod 7.5 mg BID at Week 12|
1628846|NCT02145468|2992106|Superiority||Hazard Ratio (HR)|1.11||||0.329|2-Sided|95.0|0.9|1.38|||Log Rank||"Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk.~with the treatment compared with placebo."||
1628847|NCT02145468|2992107|Superiority||Hazard Ratio (HR)|1.16||||0.238|2-Sided|95.0|0.91|1.47|||Log Rank||Hazard ratio and CI are estimated using a Cox proportional hazard regression model stratified by baseline STEMI/NSTEMI status with treatment as the only covariate. A hazard ratio <1 indicates a lower risk with the treatment compared with placebo.||
1628848|NCT02145429|2992108|Other||Mean Difference (Final Values)|-0.14||||0.26|2-Sided|95.0|-1.89|1.62|||Mixed Models Analysis||||
1628849|NCT02145429|2992109|Other||Mean Difference (Final Values)|-1.18|||<|0.001|2-Sided|95.0|-2.03|-0.31|||Mixed Models Analysis||||
1628850|NCT02145429|2992110|Other||Hazard Ratio (HR)|0.32||||0.04|2-Sided|95.0|0.1|0.98|||Log Rank||||
1628851|NCT02145403|2992117|Other||Kaplan-Meier|0.32|||||2-Sided|95.0|0.2|0.51|||||||
1628852|NCT02145182|2992140|Superiority||Odds Ratio (OR)|0.81||||0.3983|2-Sided|95.0|0.49|1.33|||Regression, Logistic|Logistic regression results for the DGF composite, the effect of treatment adjusted for preservation type, donor type, and Irish score.|Calculated using the logistic regression model.|Analysis of DGF composite|
1628853|NCT02145156|2992154|Superiority or Other|||||||0.35|||||||Chi-squared||||
1628854|NCT02145156|2992154|Superiority or Other|||||||0.6|||||||Chi-squared||||
1628855|NCT02145156|2992154|Superiority or Other|||||||0.17|||||||Chi-squared||||
1628856|NCT02145156|2992154|Superiority or Other|||||||0.38|||||||Chi-squared||||
1628857|NCT02145156|2992155|Superiority or Other|||||||0.03|||||||Chi-squared||||
1628858|NCT02145156|2992155|Superiority or Other|||||||0.15|||||||Chi-squared||||
1628859|NCT02145156|2992155|Superiority or Other|||||||0.51|||||||Chi-squared||||
1628860|NCT02145156|2992155|Superiority or Other|||||||0.09|||||||Chi-squared||||
1628861|NCT02145156|2992156|Superiority or Other|||||||0.14|||||||Chi-squared||||
1628862|NCT02145156|2992156|Superiority or Other|||||||0.49|||||||Chi-squared||||
1628863|NCT02145156|2992156|Superiority or Other|||||||0.51|||||||Chi-squared||||
1628864|NCT02145156|2992156|Superiority or Other|||||||0.39|||||||Chi-squared||||
1628865|NCT02145156|2992157|Superiority or Other|||||||0.35|||||||Chi-squared||||
1628866|NCT02145156|2992157|Superiority or Other|||||||0.6|||||||Chi-squared||||
1628867|NCT02145156|2992157|Superiority or Other|||||||0.17|||||||Chi-squared||||
1628868|NCT02145156|2992157|Superiority or Other|||||||0.38|||||||Chi-squared||||
1628869|NCT02145156|2992158|Superiority or Other|||||||0.74|||||||Chi-squared||||
1628870|NCT02145156|2992158|Superiority or Other|||||||0.59|||||||Chi-squared||||
1628871|NCT02145156|2992158|Superiority or Other|||||||0.41|||||||Chi-squared||||
1628872|NCT02145156|2992158|Superiority or Other|||||||0.7|||||||Chi-squared||||
1628873|NCT02145156|2992159|Superiority or Other|||||||0.76|||||||Chi-squared||||
1628874|NCT02145156|2992159|Superiority or Other|||||||0.81|||||||Chi-squared||||
1628875|NCT02145156|2992159|Superiority or Other|||||||0.62|||||||Chi-squared||||
1628876|NCT02145156|2992159|Superiority or Other|||||||0.87|||||||Chi-squared||||
1628877|NCT02145156|2992160|Superiority or Other|||||||0.7|||||||Fisher Exact||||
1628878|NCT02145156|2992160|Superiority or Other|||||||0.25|||||||Fisher Exact||||
1628879|NCT02145156|2992160|Superiority or Other|||||||0.23|||||||Fisher Exact||||
1628880|NCT02145156|2992160|Superiority or Other|||||||0.37|||||||Fisher Exact||||
1628881|NCT02145156|2992161|Superiority or Other|||||||0.34|||||||Fisher Exact||||
1628903|NCT02144610|2992188|Superiority or Other|||||||0.486|||||||ANCOVA|||Change from Baseline at Month 15|
1628904|NCT02144610|2992188|Superiority or Other|||||||0.916|||||||ANCOVA|||Change from Baseline at Month 12|
1628905|NCT02144610|2992188|Superiority or Other|||||||0.1|||||||ANCOVA|||Change from Baseline at Month 9|
1628906|NCT02144610|2992188|Superiority or Other|||||||0.584|||||||ANCOVA|||Change from Baseline at Month 6|
1628907|NCT02144610|2992188|Superiority or Other|||||||0.941|||||||ANCOVA|||Change from Baseline at Month 3|
1628908|NCT02144610|2992189|Superiority or Other|||||||0.802|||||||ANCOVA|||Composite Overall (LOCF)|
1628909|NCT02144610|2992189|Superiority or Other|||||||0.782|||||||ANCOVA|||Emotional Functioning (LOCF)|
1628910|NCT02144610|2992189|Superiority or Other|||||||0.905|||||||ANCOVA|||Social (LOCF)|
1628911|NCT02144610|2992189|Superiority or Other|||||||0.94|||||||ANCOVA|||Activities (LOCF)|
1628912|NCT02144610|2992189|Superiority or Other|||||||0.557|||||||ANCOVA|||Symptom (LOCF)|
1628913|NCT02144610|2992189|Superiority or Other|||||||0.105|||||||ANCOVA|||Pain (LOCF)|
1628914|NCT02144610|2992190|Superiority or Other|||||||0.033|||||||ANCOVA|||Change from Baseline at LOCF|
1628915|NCT02144610|2992190|Superiority or Other|||||||0.83|||||||ANCOVA|||Change from Baseline at Month 15|
1628916|NCT02144610|2992190|Superiority or Other|||||||0.771|||||||ANCOVA|||Change from Baseline at Month 12|
1628917|NCT02144610|2992190|Superiority or Other|||||||0.709|||||||ANCOVA|||Change from Baseline at Month 9|
1628918|NCT02144610|2992190|Superiority or Other|||||||0.032|||||||ANCOVA|||Change from Baseline at Month 6|
1628919|NCT02144610|2992190|Superiority or Other|||||||0.147|||||||ANCOVA|||Change from Baseline at Month 3|
1628920|NCT02144610|2992191|Superiority or Other|||||||0.74|||||||ANCOVA|||Change from Baseline at LOCF|
1628921|NCT02144610|2992191|Superiority or Other|||||||0.643|||||||ANCOVA|||Change from Baseline at Month 15|
1628922|NCT02144610|2992191|Superiority or Other|||||||0.327|||||||ANCOVA|||Change from Baseline at Month 12|
1628923|NCT02144610|2992191|Superiority or Other|||||||0.315|||||||ANCOVA|||Change from Baseline at Month 9|
1628924|NCT02144610|2992191|Superiority or Other|||||||0.32|||||||ANCOVA|||Change from Baseline at Month 6|
1628925|NCT02144610|2992191|Superiority or Other|||||||0.268|||||||ANCOVA|||Change from Baseline at Month 3|
1628926|NCT02144610|2992192|Superiority or Other|||||||0.233|||||||ANCOVA|||Change from Baseline at LOCF|
1628927|NCT02144610|2992192|Superiority or Other|||||||0.854|||||||ANCOVA|||Change from Baseline at Month 15|
1628928|NCT02144610|2992192|Superiority or Other|||||||0.468|||||||ANCOVA|||Change from Baseline at Month 12|
1628929|NCT02144610|2992192|Superiority or Other|||||||0.725|||||||ANCOVA|||Change from Baseline at Month 9|
1628930|NCT02144610|2992192|Superiority or Other|||||||0.036|||||||ANCOVA|||Change from Baseline at Month 6|
1628931|NCT02144610|2992192|Superiority or Other|||||||0.211|||||||ANCOVA|||Change from Baseline at Month 3|
1628932|NCT02144610|2992193|Superiority or Other|||||||0.051|||||||ANCOVA|||Change from Baseline at LOCF (Posterior Tibial)|
1628933|NCT02144610|2992193|Superiority or Other|||||||0.114|||||||ANCOVA|||Change from Baseline at Month 12 (Posterior Tibial)|
1628934|NCT02144610|2992193|Superiority or Other|||||||0.886|||||||ANCOVA|||Change from Baseline at Month 9 (Posterior Tibial)|
1628935|NCT02144610|2992193|Superiority or Other|||||||0.414|||||||ANCOVA|||Change from Baseline at Month 6 (Posterior Tibial)|
1628936|NCT02144610|2992193|Superiority or Other|||||||0.759|||||||ANCOVA|||Change from Baseline at Month 3 (Posterior Tibial)|
1628937|NCT02144610|2992193|Superiority or Other|||||||0.324|||||||ANCOVA|||Change from Baseline at LOCF (Dorsalis Pedis)|
1628938|NCT02144610|2992193|Superiority or Other|||||||0.28|||||||ANCOVA|||Change from Baseline at Month 12 (Dorsalis Pedis)|
1628939|NCT02144610|2992193|Superiority or Other|||||||0.789|||||||ANCOVA|||Change from Baseline at Month 9 (Dorsalis Pedis)|
1628940|NCT02144610|2992193|Superiority or Other|||||||0.668|||||||ANCOVA|||Change from Baseline at Month 6 (Dorsalis Pedis)|
1628941|NCT02144610|2992193|Superiority or Other|||||||0.803|||||||ANCOVA|||Change from Baseline at Month 3 (Dorsalis Pedis)|
1628942|NCT02144610|2992194|Superiority or Other|||||||0.989|||||||ANCOVA|||Change from baseline at LOCF (left brachial)|
1628943|NCT02144610|2992194|Superiority or Other|||||||0.423|||||||ANCOVA|||Change from baseline at Month 15 (left brachial)|
1628944|NCT02144610|2992194|Superiority or Other|||||||0.044|||||||ANCOVA|||Change from baseline at Month 12 (left brachial)|
1628945|NCT02144610|2992194|Superiority or Other|||||||0.521|||||||ANCOVA|||Change from baseline at Month 9 (left brachial)|
1628946|NCT02144610|2992194|Superiority or Other|||||||0.39|||||||ANCOVA|||Change from baseline at Month 6 (left brachial)|
1628947|NCT02144610|2992194|Superiority or Other|||||||0.378|||||||ANCOVA|||Change from baseline at Month 3 (left brachial)|
1628948|NCT02144610|2992194|Superiority or Other|||||||0.167|||||||ANCOVA|||Change from baseline at last observation carried forward (LOCF) (right brachial)|
1628949|NCT02144610|2992194|Superiority or Other|||||||0.896|||||||ANCOVA|||Change from baseline at Month 15 (right brachial)|
1628950|NCT02144610|2992194|Superiority or Other|||||||0.216|||||||ANCOVA|||Change from baseline at Month 12 (right brachial)|
1628951|NCT02144610|2992194|Superiority or Other|||||||0.487|||||||ANCOVA|||Change from baseline at Month 9 (right brachial)|
1628952|NCT02144610|2992194|Superiority or Other|||||||0.808|||||||ANCOVA|||Change from baseline at Month 6 (right brachial)|
1628953|NCT02144610|2992194|Superiority or Other|||||||0.733|||||||ANCOVA|||Change from baseline at Month 3 (right brachial)|
1628954|NCT02144610|2992197|Superiority or Other|||||||0.002|||||||ANCOVA|||Change from Baseline at last observation carried forward (LOCF)|
1628955|NCT02144610|2992197|Superiority or Other|||||||0.153|||||||ANCOVA|||Change from Baseline at Month 15|
1628956|NCT02144610|2992197|Superiority or Other|||||||0.111|||||||ANCOVA|||Change from Baseline at Month 12|
1628957|NCT02144610|2992197|Superiority or Other|||||||0.863|||||||ANCOVA|||Change from Baseline at Month 9|
1628958|NCT02144610|2992197|Superiority or Other|||||||0.445|||||||ANCOVA|||Change from Baseline at Month 6|
1628959|NCT02144610|2992197|Superiority or Other|||||||0.514|||||||ANCOVA|||Change from Baseline at Month 3|
1628960|NCT02144610|2992198|Superiority or Other||||||>|0.999|||||||Fisher Exact|||0-18 Months (Major Amputation or Revascularization)|
1628961|NCT02144610|2992198|Superiority or Other||||||>|0.999|||||||Fisher Exact|||0-12 Months (Major Amputation or Revascularization)|
1628962|NCT02144610|2992198|Superiority or Other||||||>|0.7575|||||||Fisher Exact|||0-6 Months (Major Amputation or Revascularization)|
1628963|NCT02144610|2992198|Superiority or Other||||||>|0.999|||||||Fisher Exact|||0-18 Months (Major Amputation or Death)|
1628964|NCT02144610|2992198|Superiority or Other||||||>|0.7575|||||||Fisher Exact|||0-12 Months (Major Amputation or Death)|
1628965|NCT02144610|2992198|Superiority or Other||||||>|0.5136|||||||Fisher Exact|||0-6 Months (Major Amputation or Death)|
1628966|NCT02144610|2992198|Superiority or Other||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-18 Months|
1628967|NCT02144610|2992198|Superiority or Other||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-12 Months|
1628968|NCT02144610|2992198|Superiority or Other||||||>|0.999|||||||Fisher Exact|||All-cause death at 0-6 Months|
1628969|NCT02144610|2992198|Superiority or Other||||||>|0.4591|||||||Fisher Exact|||Revascularization at 0-18 Months|
1628970|NCT02144610|2992198|Superiority or Other||||||>|0.4591|||||||Fisher Exact|||Revascularization at 0-12 Months|
1628971|NCT02144610|2992198|Superiority or Other||||||>|0.999|||||||Fisher Exact|||Revascularization at 0-6 Months|
1628972|NCT02144610|2992198|Superiority or Other||||||>|0.999|||||||Fisher Exact|||Major amputation at 0-18 Months|
1628973|NCT02144610|2992198|Superiority or Other||||||>|0.999|||||||Fisher Exact|||Major amputation at 0-12 Months|
1628974|NCT02144610|2992198|Superiority or Other||||||>|0.7381|||||||Fisher Exact|||Major amputation at 0-6 Months|
1628975|NCT02144610|2992198|Superiority or Other||||||>|0.999|||||||Fisher Exact|||Stroke at 0-18 Months|
1628976|NCT02144610|2992198|Superiority or Other||||||>|0.999|||||||Fisher Exact|||Stroke at 0-12 Months|
1628977|NCT02144610|2992198|Superiority or Other||||||>|0.999|||||||Fisher Exact|||Stroke at 0-6 Months|
1628978|NCT02144610|2992198|Superiority or Other||||||>|0.4889|||||||Fisher Exact|||MI at 0-18 Months|
1628979|NCT02144610|2992198|Superiority or Other||||||>|0.4889|||||||Fisher Exact|||MI at 0-12 Months|
1628980|NCT02144610|2992198|Superiority or Other||||||>|0.999|||||||Fisher Exact|||MI at 0-6 Months|
1628981|NCT02144519|2992199|Superiority||Odds Ratio (OR)|3.8||||0.003|2-Sided|95.0|1.45|9.95|||Regression, Logistic||||
1628982|NCT02144519|2992200|Superiority||Odds Ratio (OR)|1.88||||0.008|2-Sided|95.0|1.18|3.0|||Mixed Models Analysis||||
1628983|NCT02144285|2992212|Superiority or Other||Absolute Bioavailability|0.45|||||2-Sided|90.0|0.34|0.6|||||||
1628984|NCT02144259|2992216|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1628985|NCT02144259|2992218|Superiority or Other||||||<|0.05|||||||GEE|||Because the expected amount of postpartum weight loss in non-breastfeeding women is not documented in the literature, we chose a sample size that would enable us to detect a one standard deviation difference in weight loss between the 3 groups at the primary 6 month endpoint. We used generalized estimating equations (GEEs) to test differences among all 3 groups over all the study periods.|
1628986|NCT02144233|2992240|Superiority|||||||0.54|||||||Mixed Models Analysis||||
1628987|NCT02144220|2992246|Superiority or Other|||||||0.39|||||||t-test, 2 sided||||
1628988|NCT02144077|2992259|Non-Inferiority or Equivalence|Non-inferiority margin of -15%|Difference in Percentage|1.6|||<|0.0001|1-Sided|97.5|-6.5||||Farrington and Manning Test|Difference of proportions|||
1628989|NCT02143947|2992276|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis||||
1628990|NCT02143947|2992277|Superiority or Other||||||>|0.1|||||||Mixed Models Analysis||||
1628991|NCT02143947|2992278|Superiority or Other||||||=|0|||||||Mixed Models Analysis||||
1628992|NCT02143947|2992279|Superiority or Other||||||>|0.1|||||||Mixed Models Analysis||||
1628993|NCT02142894|2992317|Equivalence|The results are analyzed in a 2x2 contingency table with 95%CI.|2 x 2 contingency table|87.9|||||2-Sided|95.0|72.7|95.2|||||||
1628994|NCT02142738|2992318|Superiority or Other (legacy)||Difference in percentages|16.6||||0.0011|2-Sided|95.0|6.0|27.0||One-sided p-value for testing|Miettinen & Nurminem method|Stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)||H0: difference in %=0 vs. H1: difference in % >0|
1628995|NCT02142738|2992319|Superiority or Other (legacy)||Hazard Ratio (HR)|0.6||||0.005|2-Sided|95.0|0.41|0.89||One-sided p-value based on log-rank test|Regression, Cox|Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)|||
1628996|NCT02142738|2992320|Superiority or Other (legacy)||Hazard Ratio (HR)|0.5|||<|0.001|2-Sided|95.0|0.37|0.68||One-sided p-value based on log-rank test|Regression, Cox|Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)|||
1628997|NCT02142387|2992353|Other|||||||0.11|||||||Chi-squared||||
1628998|NCT02142387|2992354|Other|||||||0.7|||||||Chi-squared||||
1628999|NCT02142387|2992355|Other|||||||0.34|||||||Chi-squared||||
1629000|NCT02141997|2992419|Superiority or Other||||||=|0|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.|
1629001|NCT02141997|2992419|Superiority or Other||||||=|0|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.|
1629002|NCT02141997|2992419|Superiority or Other||||||=|0|||||||Fisher Exact|||P-value calculated using 1-sided Fisher's Exact test.|
1629003|NCT02141854|2992430|Superiority or Other||LSM difference|0.209||||0.0435|2-Sided|95.0|0.006|0.411||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629004|NCT02141854|2992430|Superiority or Other||LSM difference|0.253||||0.0143|2-Sided|95.0|0.051|0.455||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629005|NCT02141854|2992430|Superiority or Other||LSM difference|0.15||||0.149|2-Sided|95.0|-0.054|0.354||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629006|NCT02141854|2992430|Superiority or Other||Slope|0.681||||0|2-Sided|95.0|0.478|0.885||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629007|NCT02141854|2992430|Superiority or Other||LSM difference|0.623||||0|2-Sided|95.0|0.418|0.828||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629008|NCT02141854|2992430|Superiority or Other||LSM difference|0.428||||0|2-Sided|95.0|0.224|0.632||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629009|NCT02141854|2992430|Superiority or Other||LSM difference|0.473||||0|2-Sided|95.0|0.269|0.677||Significance level of 0.05.|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629010|NCT02141854|2992431|Superiority or Other|||||||0.325||||||Significance level of 0.05.|Log Rank||||
1629011|NCT02141854|2992431|Superiority or Other|||||||0.996||||||Significance level of 0.05.|Log Rank||||
1629012|NCT02141854|2992431|Superiority or Other|||||||0.7203||||||Significance level of 0.05.|Log Rank||||
1629013|NCT02141854|2992431|Superiority or Other||||||<|0.0001||||||Significance level of 0.05.|Log Rank||||
1629014|NCT02141854|2992431|Superiority or Other||||||<|0.0003||||||Significance level of 0.05.|Log Rank||||
1629015|NCT02141854|2992431|Superiority or Other||||||<|0.0001||||||Significance level of 0.05.|Log Rank||||
1629016|NCT02141854|2992431|Superiority or Other||||||<|0.0001||||||Significance level of 0.05.|Log Rank||||
1629017|NCT02141854|2992432|Superiority or Other||LSM difference|-0.287||||0.0588|2-Sided|95.0|-0.584|0.011||Significance level of 0.05.|Wilcoxon (Mann-Whitney)|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629018|NCT02141854|2992432|Superiority or Other||LSM difference|-0.382||||0.0124|2-Sided|95.0|-0.681|-0.083||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629019|NCT02141854|2992432|Superiority or Other||LSM difference|-0.364||||0.016|2-Sided|95.0|-0.659|-0.068||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629020|NCT02141854|2992432|Superiority or Other||LSM difference|-0.989||||0|2-Sided|95.0|-1.291|-0.686||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629021|NCT02141854|2992432|Superiority or Other||LSM difference|-1.066||||0|2-Sided|95.0|-1.365|-0.766||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629022|NCT02141854|2992432|Superiority or Other||LSM difference|-0.607||||0.0001|2-Sided|95.0|-0.908|-0.307||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629053|NCT02140775|2992540|Superiority|||||||0.602|||||||Chi-squared|degrees of freedom = 1||A Chi-Square test was conducted between the treatment groups and the dichotomous outcome of successful achievement of employment goal.|
1629232|NCT02137512|2992880|Superiority|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629023|NCT02141854|2992432|Superiority or Other||LSM difference|-0.702||||0|2-Sided|95.0|-1.001|-0.403||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629024|NCT02141854|2992433|Superiority or Other||LSM difference|-0.121||||0.0094|2-Sided|95.0|-0.213|-0.03||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629025|NCT02141854|2992433|Superiority or Other||LSM difference|-0.082||||0.0818|2-Sided|95.0|-0.174|0.01||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629026|NCT02141854|2992433|Superiority or Other||LSM difference|-0.149||||0.0014|2-Sided|95.0|-0.239|-0.058||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629027|NCT02141854|2992433|Superiority or Other||LSM difference|-0.277||||0|2-Sided|95.0|-0.37|-0.184||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629028|NCT02141854|2992433|Superiority or Other||LSM difference|-0.304||||0|2-Sided|95.0|-0.397|-0.212||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629029|NCT02141854|2992433|Superiority or Other||LSM difference|-0.195||||0|2-Sided|95.0|-0.288|-0.102||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629030|NCT02141854|2992433|Superiority or Other||LSM difference|-0.156||||0.001|2-Sided|95.0|-0.248|-0.063||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629031|NCT02141854|2992434|Superiority or Other||LSM difference|11.146||||0.001|2-Sided|95.0|4.511|17.782||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629032|NCT02141854|2992434|Superiority or Other||LSM difference|12.879||||0.0002|2-Sided|95.0|6.216|19.541||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629033|NCT02141854|2992434|Superiority or Other||LSM difference|12.771||||0.0002|2-Sided|95.0|6.179|19.363||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629034|NCT02141854|2992434|Superiority or Other||LSM difference|29.597||||0|2-Sided|95.0|22.839|36.354||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629035|NCT02141854|2992434|Superiority or Other||LSM difference|31.221||||0|2-Sided|95.0|24.513|37.93||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629075|NCT02140645|2992570|Superiority or Other||C-statistics|0.801|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629233|NCT02137512|2992880|Superiority|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629036|NCT02141854|2992434|Superiority or Other||LSM difference|16.718||||0|2-Sided|95.0|9.988|23.449||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629037|NCT02141854|2992434|Superiority or Other||LSM difference|18.45||||0|2-Sided|95.0|11.751|25.15||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629038|NCT02141854|2992435|Superiority or Other||LSM difference|0.123||||0.0047|2-Sided|95.0|0.038|0.208||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the eighth in the sequence.|
1629039|NCT02141854|2992435|Superiority or Other||LSM difference|0.183||||0|2-Sided|95.0|0.098|0.268||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the seventh in the sequence.|
1629040|NCT02141854|2992435|Superiority or Other||LSM difference|0.274||||0|2-Sided|95.0|0.189|0.36||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the sixth in the sequence.|
1629041|NCT02141854|2992435|Superiority or Other||LSM difference|0.276||||0|2-Sided|95.0|0.191|0.361||Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fifth in the sequence.|
1629042|NCT02141854|2992436|Superiority or Other||LSM difference|0.322||||0|2-Sided|95.0|0.212|0.432||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fourth in the sequence.|
1629043|NCT02141854|2992436|Superiority or Other||LSM difference|0.326||||0|2-Sided|95.0|0.221|0.431||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the third in the sequence.|
1629044|NCT02141854|2992436|Superiority or Other||LSM difference|0.182||||0.001|2-Sided|95.0|0.074|0.291||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the second in the sequence.|
1629045|NCT02141854|2992436|Superiority or Other||LSM difference|0.179||||0.0009|2-Sided|95.0|0.074|0.285||Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.|ANCOVA|||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the first in the sequence.|
1629046|NCT02141295|2992519|Other||Hazard Ratio (HR)|0.85|||=|0|2-Sided|95.0|0.49|1.49|||Log Rank|||Kaplan-Meier methods were used to estimate median OS for each treatment arm and the 95% CIs for median OS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. >1) and country/region (USA vs rest of the world).|
1629047|NCT02141295|2992522|Other||Hazard Ratio (HR)|0.91|||=|0|2-Sided|95.0|0.6|1.39||log-rank|Regression, Cox|||Kaplan-Meier methods were used to estimate median PFS for each treatment arm and the 95% CIs for median PFS were computed using the Brookmeyer and Crowley method. The stratified Cox proportional hazard was used to estimate the hazard ratio (i.e., the magnitude of the treatment effect) and the corresponding 95% confidence interval. The stratification factors are number of metastatic sites (1 vs. >1) and country/region (USA vs rest of the world).|
1629048|NCT02141217|2992527|Non-Inferiority or Equivalence|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|2.3|||||2-Sided|95.0|-4.4|9.0|||||||
1629049|NCT02141217|2992528|Non-Inferiority or Equivalence|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|0.9|||||2-Sided|95.0|-5.6|7.4|||||||
1629050|NCT02141217|2992529|Non-Inferiority or Equivalence|The assessment of non-inferiority was based on Farrington and Manning method. The upper limit of two-sided 95% confidence interval of less than 10 % provide enough evidence to show the non-inferiority between the treatment arms.|Treatment Difference (percentage)|1.5|||||2-Sided|95.0|-4.9|8.0|||||||
1629051|NCT02140775|2992538|Superiority||Mean Difference (Final Values)|-3.25|Standard Error of the Mean|7.68||0.674|2-Sided|95.0|-18.59|12.09|||t-test, 2 sided||||
1629052|NCT02140775|2992539|Superiority||Mean Difference (Final Values)|-3.74|Standard Error of the Mean|2.0||0.066|2-Sided|95.0|-7.75|0.26|||t-test, 2 sided||||
1629054|NCT02140762|2992565|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|11.8|||||2-Sided|||||||||Vaccine effectiveness<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)*100].|
1629055|NCT02140762|2992565|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|20.9|||||2-Sided|||||||||Vaccine effectiveness<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)*100].|
1629056|NCT02140762|2992565|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|15.5|||||2-Sided|||||||||Vaccine effectiveness<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)*100].|
1629057|NCT02140762|2992565|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|36.4|||||2-Sided|||||||||Vaccine effectiveness<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)*100].|
1629058|NCT02140762|2992565|Superiority or Other||Vaccine Effectiveness|20.0|||<|0.0001|2-Sided|95.0|16.0|23.0||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|Generalized Linear Model||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of 95% CI for VE is > 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the 2nd injection for each strain is defined as [1 - (% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/% of subjects without bactericidal activity at 1:8 dilution in MenACWY group)] x 100. The combined VE across all strains was computed by mean of a generalized linear model.|
1629059|NCT02140762|2992566|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|40.9|||||2-Sided|||||||||Vaccine effectiveness<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)*100].|
1629060|NCT02140762|2992566|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|10.9|||||2-Sided|||||||||Vaccine effectiveness<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)*100].|
1629061|NCT02140762|2992566|Other|For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)*100].|Vaccine Effectiveness|19.1|||||2-Sided|||||||||Vaccine effectiveness<30%|
1629062|NCT02140762|2992566|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|25.5|||||2-Sided|||||||||Vaccine effectiveness<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity at 1:8 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)*100].|
1629063|NCT02140762|2992566|Superiority or Other||Vaccine Effectiveness|46.0|||<|0.0001|2-Sided|95.0|43.0|49.0|||Generalized Linear Model||VE is based on the relative risk (RR).The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects:treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤ 10%. If the lower limit of the 95% CI for VE is >10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as [1-(% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:8 dilution in MenACWY group)]x100. The combined VE across all strains will be computed by mean of a generalized linear model.|
1629171|NCT02138916|2992686|Superiority||Mean Difference (Final Values)|-0.81||||0.0753|2-Sided|95.0|-1.7|0.08|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1629064|NCT02140762|2992567|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|38.2|||||2-Sided|||||||||Vaccine effectiveness<100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)*100].|
1629065|NCT02140762|2992567|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|19.1|||||2-Sided|||||||||Vaccine effectiveness<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)*100].|
1629066|NCT02140762|2992567|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|22.7|||||2-Sided|||||||||Vaccine effectiveness<30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)*100].|
1629067|NCT02140762|2992567|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|9.1|||||2-Sided|||||||||Vaccine effectiveness<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity at 1:4 dilution in MenABCWY group)/(% of not killed strains/without bactericidal activity in ACWY group)*100].|
1629068|NCT02140762|2992567|Superiority or Other||Vaccine effectiveness|44.0|||<|0.0001|2-Sided|95.0|41.0|47.0|||General Linear Model (GLM)||VE is based on the relative risk (RR). The POISSON DISTRIBUTION and LOG LINK options was used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the LL of the 95% CI for VE is > 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 4 months after the second injection for each strain is defined as [1 - (% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)] x 100.The combined VE across all strains will be computed by mean of a generalized linear model.|
1629069|NCT02140762|2992568|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|59.1|||||2-Sided|||||||||Vaccine effectiveness <100% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)*100].|
1629070|NCT02140762|2992568|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|18.2|||||2-Sided|||||||||Vaccine effectiveness<60% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)*100].|
1629071|NCT02140762|2992568|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|12.7|||||2-Sided|||||||||Vaccine effectiveness <30% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)*100].|
1629072|NCT02140762|2992568|Other|Vaccine effectiveness at one month after the second vaccination against each of the endemic US N.meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.|Vaccine Effectiveness|4.6|||||2-Sided|||||||||vaccine effectiveness<10% For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated. For each strain, vaccine effectiveness (VE) of the MenABCWY compared to MenACWY was evaluated as VE= [1- (% not killed/without bactericidal activity strains in ABCWY)/(% of not killed strains/without bactericidal activity strains in ACWY)*100].|
1629073|NCT02140762|2992568|Superiority or Other||Vaccine Effectiveness|67.0|||<|0.0001|2-Sided|95.0|65.0|69.0|||Generalized Linear Model||VE is based on the relative risk (RR). The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects: treatment group, strain (and center).|H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%. If the lower limit of the 95% CI for VE is > 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as [1-(% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)]x100. The combined VE across all strains will be computed by mean of a generalized linear model.|
1629074|NCT02140645|2992569|Superiority or Other||C-statistics|0.836|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629076|NCT02140645|2992571|Superiority or Other||C-statistics|0.827|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629077|NCT02140645|2992572|Superiority or Other||C-statistics|0.733|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629078|NCT02140645|2992573|Superiority or Other||C-statistics|0.618|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629079|NCT02140645|2992574|Superiority or Other||C-statistics|0.618|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629080|NCT02140645|2992575|Superiority or Other||C-statistics|0.757|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629081|NCT02140645|2992576|Superiority or Other||C-statistics|0.683|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629082|NCT02140645|2992577|Superiority or Other||C-statistics|0.699|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629083|NCT02140645|2992578|Superiority or Other||R-squared|0.1753|||||||||||||The R-squared can be between 0 and 1 and a value of 0 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629084|NCT02140645|2992579|Superiority or Other||C-statistics|0.623|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629085|NCT02140645|2992580|Superiority or Other||R-squared|0.0858|||||||||||||The R-squared can be between 0 and 1 and a value of 0 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629086|NCT02140645|2992581|Superiority or Other||C-statistcs|0.597|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629087|NCT02140645|2992582|Superiority or Other||C-statistics|0.624|||||||||||||The C-statistics can be between 0.5 and 1 and a value of 0.5 indicates that the model is no better than chance at making a prediction and a value of 1.0 indicates that the model perfectly identifies those within a group and those not.||
1629088|NCT02140593|2992583|Superiority or Other||Mean Difference (Net)|1.0|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1629089|NCT02140593|2992584|Superiority or Other||Mean Difference (Final Values)|0.75|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1629090|NCT02139878|2992622|Superiority or Other||||||=|0|||||||ANCOVA||||
1629091|NCT02139878|2992623|Superiority or Other||||||=|0|||||||ANCOVA||||
1629092|NCT02139644|2992626|Superiority or Other||LSM difference|-0.071||||0.4934|2-Sided|95.0|-0.275|0.133||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629093|NCT02139644|2992626|Superiority or Other||LSM difference|-0.023||||0.8216|2-Sided|95.0|-0.223|0.177||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629094|NCT02139644|2992626|Superiority or Other||LSM difference|0.172||||0.0913|2-Sided|95.0|-0.028|0.372||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629095|NCT02139644|2992626|Superiority or Other||LSM difference|0.23||||0.0293|2-Sided|95.0|0.023|0.437||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629096|NCT02139644|2992626|Superiority or Other||LSM difference|0.473||||0|2-Sided|95.0|0.27|0.676||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629097|NCT02139644|2992626|Superiority or Other||LSM difference|0.253||||0.0155|2-Sided|95.0|0.048|0.458||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629172|NCT02138916|2992686|Superiority||Mean Difference (Final Values)|-0.19||||0.6782|2-Sided|95.0|-1.08|0.7|||Mixed Models Analysis|Model includes treatment group, baseline CAT total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1629098|NCT02139644|2992626|Superiority or Other||LSM difference|0.301||||0.0044|2-Sided|95.0|0.094|0.508||Significance level of 0.05|ANCOVA|||The change from baseline in AQLQ(S) score (patients ≥18 years of age) at endpoint (ie, last postbaseline observation) was analyzed using an ANCOVA model with effects due to baseline AQLQ(S) score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment, imputing missing data via last observation carried forward (LOCF).|
1629099|NCT02139644|2992627|Superiority or Other|||||||0.9999||||||Significance level of 0.05|Log Rank||||
1629100|NCT02139644|2992627|Superiority or Other|||||||0.993||||||Significance level of 0.05|Log Rank||||
1629101|NCT02139644|2992627|Superiority or Other|||||||0.3134||||||Significance level of 0.05|Log Rank||||
1629102|NCT02139644|2992627|Superiority or Other|||||||0.1718||||||Significance level of 0.05|Log Rank||||
1629103|NCT02139644|2992627|Superiority or Other|||||||0.0437||||||Significance level of 0.05|Log Rank||||
1629104|NCT02139644|2992627|Superiority or Other|||||||0.1701||||||Significance level of 0.05|Log Rank||||
1629105|NCT02139644|2992627|Superiority or Other|||||||0.1679||||||Significance level of 0.05|Log Rank||||
1629106|NCT02139644|2992628|Superiority or Other||LSM difference|-0.241||||0.0626|2-Sided|95.0|-0.494|0.013||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629107|NCT02139644|2992628|Superiority or Other||LSM difference|-0.239||||0.064|2-Sided|95.0|-0.492|0.014||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629108|NCT02139644|2992628|Superiority or Other||LSM difference|-0.212||||0.1014|2-Sided|95.0|-0.465|0.042||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629109|NCT02139644|2992628|Superiority or Other||LSM difference|-0.704||||0|2-Sided|95.0|-0.957|-0.45||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629110|NCT02139644|2992628|Superiority or Other||LSM difference|-0.675||||0|2-Sided|95.0|-0.928|-0.421||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629111|NCT02139644|2992628|Superiority or Other||LSM difference|-0.464||||0.0003|2-Sided|95.0|-0.718|-0.211||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629112|NCT02139644|2992628|Superiority or Other||LSM difference|-0.463||||0.0004|2-Sided|95.0|-0.716|-0.209||Significance level of 0.05|mixed model for repeated measures|||The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline value, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629113|NCT02139644|2992629|Superiority or Other||LSM difference|-0.029||||0.5095|2-Sided|95.0|-0.114|0.057||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629114|NCT02139644|2992629|Superiority or Other||LSM difference|-0.051||||0.2438|2-Sided|95.0|-0.136|0.035||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629115|NCT02139644|2992629|Superiority or Other||LSM difference|-0.064||||0.1381|2-Sided|95.0|-0.15|0.021||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629116|NCT02139644|2992629|Superiority or Other||LSM difference|-0.194||||0|2-Sided|95.0|-0.279|-0.109||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629173|NCT02138916|2992687|Superiority||Mean Difference (Final Values)|-2.136||||0.0264|2-Sided|95.0|-4.02|-0.251|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1629117|NCT02139644|2992629|Superiority or Other||LSM difference|-0.23||||0|2-Sided|95.0|-0.315|-0.144||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629118|NCT02139644|2992629|Superiority or Other||LSM difference|-0.143||||0.001|2-Sided|95.0|-0.229|-0.058||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629119|NCT02139644|2992629|Superiority or Other||LSM difference|-0.165||||0.0002|2-Sided|95.0|-0.251|-0.08||Significance level of 0.05.|mixed model for repeated measures|||The change from baseline in the weekly average of the total daily asthma symptom scores over weeks 1 to 12 was analyzed using an MMRM with an unstructured covariance matrix and with effects due to baseline score, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629120|NCT02139644|2992630|Superiority or Other||LSM difference|10.347||||0.0175|2-Sided|95.0|1.822|18.872||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629121|NCT02139644|2992630|Superiority or Other||LSM difference|14.255||||0.0011|2-Sided|95.0|5.732|22.778||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629122|NCT02139644|2992630|Superiority or Other||LSM difference|9.898||||0.0233|2-Sided|95.0|1.349|18.447||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629123|NCT02139644|2992630|Superiority or Other||LSM difference|21.273||||0|2-Sided|95.0|12.728|29.818||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629124|NCT02139644|2992630|Superiority or Other||LSM difference|20.824||||0|2-Sided|95.0|12.253|29.395||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629125|NCT02139644|2992630|Superiority or Other||LSM difference|7.018||||0.1074|2-Sided|95.0|-1.531|15.567||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629126|NCT02139644|2992630|Superiority or Other||LSM difference|10.926||||0.0123|2-Sided|95.0|2.38|19.471||Significance level of 0.05.|mixed model for repeated measures|||The analysis of change from baseline in weekly average of daily (AM predose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using an mixed model for repeated measures (MMRM) with an unstructured covariance matrix and with effects due to baseline weekly average of daily AM PEF, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), week, treatment, and week-by-treatment interaction.|
1629127|NCT02139644|2992631|Superiority or Other||LSM difference|0.119||||0.0132|2-Sided|95.0|0.025|0.212|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the eighth in the sequence.|
1629128|NCT02139644|2992631|Superiority or Other||LSM difference|0.151||||0.0017|2-Sided|95.0|0.057|0.244|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the seventh in the sequence.|
1629129|NCT02139644|2992631|Superiority or Other||LSM difference|0.266||||0|2-Sided|95.0|0.172|0.36|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the sixth in the sequence.|
1629130|NCT02139644|2992631|Superiority or Other||LSM difference|0.262||||0|2-Sided|95.0|0.168|0.356|||ANCOVA|Effects due to baseline trough AM FEV1, sex, age, (pooled) center, previous therapy (ICS or ICS/LABA), and treatment.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fifth in the sequence.|
1629131|NCT02139644|2992632|Superiority or Other||LSM difference|0.325||||0|2-Sided|95.0|0.203|0.447|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the fourth in the sequence.|
1629132|NCT02139644|2992632|Superiority or Other||LSM difference|0.335||||0|2-Sided|95.0|0.216|0.453|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the third in the sequence.|
1629133|NCT02139644|2992632|Superiority or Other||LSM difference|0.131||||0.0322|2-Sided|95.0|0.011|0.25|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the second in the sequence.|
1629134|NCT02139644|2992632|Superiority or Other||LSM difference|0.154||||0.0076|2-Sided|95.0|0.041|0.267|||ANCOVA|Fixed effects of treatment, sex, (pooled) center, previous therapy (ICS or ICS/LABA), and covariates of age and baseline FEV1.||A fixed-sequence multiple testing procedure was used to control the overall Type I error rate at the 0.05 level (2-sided) for the primary endpoints analyses. Analyses appear in the defined sequence. This is the first in the sequence.|
1629135|NCT02139540|2992636|Superiority||||||<|0.05|||||||Mixed Models Analysis||||
1629136|NCT02139540|2992637|Superiority||||||<|0.05|||||||Mixed Models Analysis|||The primary outcome (HDRS-21) was analyzed with a repeated-measures mixed effects linear model using restricted maximum likelihood estimation. To adjust for the observed carryover effect, the model included a randomization group term and a three-way interaction (treatment × time × randomization group)|
1629137|NCT02139306|2992648|Superiority||Mean Difference (Net)|-0.065|Standard Error of the Mean|0.1312||0.6208|2-Sided|95.0|-0.3233|0.1934|||Mixed-model, repeated measures||||
1629138|NCT02139306|2992649|Superiority||Mean Difference (Net)|0.272|Standard Error of the Mean|1.93||0.8881|2-Sided|95.0|-3.5292|4.0731|||Mixed-model, repeated measures||||
1629139|NCT02139306|2992650|Superiority||Rate ratio|0.8567|Standard Error of the Mean|0.1577||0.4008|2-Sided|95.0|0.5973|1.2288|||Negative binomial regression||||
1629140|NCT02139306|2992651|Superiority||Mean Difference (Net)|0.597|Standard Error of the Mean|0.957||0.5336|2-Sided|95.0|-1.2881|2.4813|||Mixed-model, repeated-measures||||
1629141|NCT02139228|2992652|Superiority or Other||Vaccine Group Differences|-11.0|||||2-Sided|95.0|-18.6|-4.2|||||||
1629142|NCT02139228|2992653|Superiority or Other||Vaccine Group Ratios|0.53|||||2-Sided|95.0|0.36|0.76|||||||
1629143|NCT02139124|2992662|Superiority||Mean Difference (Final Values)|-8.1||||0.0002|2-Sided|95.0|-12.9|-3.2||The model include terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett’s adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo"|
1629144|NCT02139124|2992662|Superiority||Mean Difference (Final Values)|-2.1||||0.672|2-Sided|95.0|-6.8|2.7||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett’s adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo"|
1629145|NCT02139124|2992662|Superiority||Mean Difference (Final Values)|-6.9||||0.0013|2-Sided|95.0|-11.5|-2.2||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett’s adjustments for multiple pairwise comparisons for each active dose group with placebo.||The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo|
1629146|NCT02139124|2992662|Superiority||Mean Difference (Final Values)|-2.0||||0.675|2-Sided|95.0|-6.6|2.6||The model includes terms for treatment and baseline Clinician ADHD-5-RS score as a covariate.|ANCOVA|Analyses utilize ANCOVA models with Dunnett’s adjustments for multiple pairwise comparisons for each active dose group with placebo.||"The null hypothesis is the mean Clinician ADHD-5-RS total score at Visit 6 is not different between the active treatment and placebo."|
1629147|NCT02139046|2992663|Superiority or Other||Difference in Proportions|3.3||||0.364|2-Sided|95.0|-4.9|11.6||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.|||
1629148|NCT02139046|2992663|Superiority or Other||Difference in Proportions|7.8||||0.036|2-Sided|95.0|-0.5|16.1||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.|||
1629149|NCT02139046|2992663|Superiority or Other||Difference in Proportions|60.5|||<|0.001|2-Sided|95.0|54.6|66.3||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.|||
1629150|NCT02139046|2992663|Superiority or Other||Difference in Proportions|47.6|||<|0.001|2-Sided|95.0|41.6|53.6||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.|||
1629228|NCT02137512|2992879|Superiority|||||||0.62||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629151|NCT02139046|2992664|Superiority or Other||Difference in Proportions|-0.5||||0.869|2-Sided|95.0|-8.0|6.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.|||
1629152|NCT02139046|2992664|Superiority or Other||Difference in Proportions|1.8||||0.561|2-Sided|95.0|-5.1|8.7||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.|||
1629153|NCT02139046|2992664|Superiority or Other||Difference in Proportions|5.9||||0.064|2-Sided|95.0|-1.2|13.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.|||
1629154|NCT02139046|2992664|Superiority or Other||Difference in Proportions|2.1||||0.503|2-Sided|95.0|-4.9|9.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.|||
1629155|NCT02139046|2992665|Superiority or Other||Difference in Proportions|7.5||||0.043|2-Sided|95.0|-0.8|15.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.|||
1629156|NCT02139046|2992665|Superiority or Other||Difference in Proportions|10.2||||0.001|2-Sided|95.0|3.5|17.0||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.|||
1629157|NCT02139046|2992665|Superiority or Other||Difference in Proportions|49.8|||<|0.001|2-Sided|95.0|43.9|55.8||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the CHW Z-test which accounts for the interim analysis.|||
1629158|NCT02139046|2992665|Superiority or Other||Difference in Proportions|25.6|||<|0.001|2-Sided|95.0|20.4|30.9||To adjust for multiple comparisons, a closed testing strategy was used. Febuxostat XR 40 and 80 mg were tested separately versus placebo and the corresponding febuxostat IR group at a Bonferroni-corrected significance level of 0.025.|Z-test|Point estimates, confidence intervals, and p-values are presented using the Cui, Hung, and Wang (CHW) Z-test which accounts for the interim analysis.|||
1629159|NCT02138916|2992676|Superiority||Rate ratio|0.58||||0.0114|2-Sided|95.0|0.39|0.89|||Nagative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).|||
1629160|NCT02138916|2992676|Superiority||Rate ratio|1.06||||0.7733|2-Sided|95.0|0.73|1.53|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, previous year exacerbations associated with hospitalization (Y/N).|||
1629161|NCT02138916|2992678|Superiority||Odds Ratio (OR)|0.89||||0.4489|2-Sided|95.0|0.65|1.21|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with >=1 COPD exacerbation.|
1629162|NCT02138916|2992678|Superiority||Odds Ratio (OR)|0.9||||0.485|2-Sided|95.0|0.66|1.22|||Cochran-Mantel-Haenszel|CMH test controlling for EOS cohort, region, and background therapy.||Proportion of participants with >=1 COPD exacerbation.|
1629163|NCT02138916|2992679|Superiority||Rate ratio|0.98||||0.8688|2-Sided|95.0|0.8|1.21|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.|||
1629164|NCT02138916|2992679|Superiority||Rate ratio|1.09||||0.408|2-Sided|95.0|0.89|1.34|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.|||
1629165|NCT02138916|2992683|Superiority||Mean Difference (Final Values)|-0.044||||0.0158|2-Sided|95.0|-0.08|-0.008|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1629166|NCT02138916|2992683|Superiority||Mean Difference (Final Values)|-0.041||||0.0235|2-Sided|95.0|-0.077|-0.006|||Mixed Models Analysis|Model includes treatment group, baseline prop. of nights awakens., EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1629167|NCT02138916|2992684|Superiority||Mean Difference (Final Values)|-0.487||||0.0121|2-Sided|95.0|-0.868|-0.107|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1629168|NCT02138916|2992684|Superiority||Mean Difference (Final Values)|-0.348||||0.0728|2-Sided|95.0|-0.728|0.032|||Mixed Models Analysis|Model includes treatment group, baseline rescue med. use, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1629169|NCT02138916|2992685|Superiority||Mean Difference (Final Values)|-0.703||||0.0413|2-Sided|95.0|-1.378|-0.028|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1629170|NCT02138916|2992685|Superiority||Mean Difference (Final Values)|-0.585||||0.0889|2-Sided|95.0|-1.26|0.089|||Mixed Models Analysis|Model includes treatment group, baseline total score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1629229|NCT02137512|2992879|Superiority|||||||0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629174|NCT02138916|2992687|Superiority||Mean Difference (Final Values)|-1.011||||0.2906|2-Sided|95.0|-2.887|0.865|||Mixed Models Analysis|Model includes treatment group, baseline SGRQ score, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1629175|NCT02138916|2992688|Superiority||Mean Difference (Final Values)|0.021||||0.3285|2-Sided|95.0|-0.021|0.062|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1629176|NCT02138916|2992688|Superiority||Mean Difference (Final Values)|0.007||||0.755|2-Sided|95.0|-0.035|0.048|||Mixed Models Analysis|Model includes treatment group, baseline FEV1 value, EOS cohort, region, background therapy, visit, and treatment by visit interaction.|||
1629177|NCT02138916|2992689|Superiority||Risk Ratio (RR)|1.02||||0.8812|2-Sided|95.0|0.82|1.27|||Negative binomial|Model includes treatment group, EOS cohort, region, number of exacerbations in the previous year.|||
1629178|NCT02138916|2992689|Superiority||Risk Ratio (RR)|1.07||||0.5236|2-Sided|95.0|0.86|1.34|||Negative binomial|Model includes treatment group, region, number of exacerbations in the previous year.|||
1629179|NCT02138916|2992690|Superiority||Risk Ratio (RR)|0.83||||0.0525|2-Sided|95.0|0.69|1.0|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.|||
1629180|NCT02138916|2992690|Superiority||Rate ratio|0.96||||0.649|2-Sided|95.0|0.8|1.15|||Negative binomial|Model includes treatment group, EOS cohort, region, background therapy, number of exacerbations in the previous year.|||
1629181|NCT02138838|2992709|Superiority or Other||Treatment Difference|0.76||||0.039|2-Sided|95.0|0.04|1.48|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.|SOC+Cinacalcet - SOC||
1629182|NCT02138838|2992710|Superiority or Other||Treatment Difference|-0.34||||0.059|2-Sided|95.0|-0.7|0.01|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.|||
1629183|NCT02138838|2992711|Superiority or Other||Treatment Difference|19.0||||0.23|2-Sided|95.0|-12.5|50.5|||ANCOVA|Analysis of covariance (ANCOVA) with baseline age group as the covariate.|SOC+Cinacalcet - SOC||
1629184|NCT02138838|2992712|Superiority or Other||Treatment Difference|-10.4||||0.25|2-Sided|95.0|-27.7|6.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline age group|SOC+Cinacalcet - SOC||
1629185|NCT02138838|2992713|Superiority or Other||Treatment Difference|-9.9||||0.42|2-Sided|95.0|-33.3|13.4|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel stratified by baseline age group (6-<12 years, 12-<18 years)|SOC+Cinacalcet - SOC|A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints. The primary endpoint was tested at a 2-sided significance level of 0.05. The secondary endpoints were tested using Holm’s method at 0.05 (2-sided) should the primary endpoint achieve a significant result.|
1629186|NCT02138838|2992714|Superiority or Other||Treatment Difference|8.1||||0.48|2-Sided|95.0|-13.7|29.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by baseline age group|SOC+Cinacalcet - SOC||
1629187|NCT02138825|2992718|Superiority or Other|||||||0.3437|||||||Mantel Haenszel|||The difference in incidences in clinical worsening and mortality will be analyzed using Mantel-Haenszel weights, stratified by region.|
1629188|NCT02138825|2992719|Superiority or Other||LS mean difference|21.48||||0.2074|2-Sided|95.0|-8.75|51.71|||ANCOVA|||The evaluation of primary efficacy endpoint will be based on change from baseline in 6MWD using analysis of covariance (ANCOVA) with baseline 6MWD, treatment arm and region as factors.|
1629189|NCT02138747|2992729|Superiority or Other (legacy)||LS Mean Difference|0.11|Standard Error of the Mean|0.199||0.211|2-Sided|95.0|-0.28|0.5||Adjusted P value was generated from the ANCOVA model for the period-by-treatment interaction.|ANCOVA|||Adjusted difference vs mirabegron where difference used mirabegron as the reference (difference = tolterodine ER – mirabegron).|
1629190|NCT02138747|2992730|Superiority or Other (legacy)||LS Mean Difference|0.05|Standard Error of the Mean|0.224||0.971|2-Sided|95.0|-0.39|0.49||Adjusted P value was generated from the ANCOVA model for the period-by-treatment interaction.|ANCOVA|||Adjusted difference vs mirabegron where difference used mirabegron as the reference (difference = tolterodine ER – mirabegron).|
1629191|NCT02138747|2992739|Superiority or Other (legacy)|||||||0.77||||||P value was obtained using Mainland-Gart test to compare the proportion of preference for each treatment group. The denominator excluded patients with No Preference.|Mainland-Gart|||Participants who selected Mirabegron or Tolterodine ER were included in the denominator and participants with No Preference were excluded. Comparison was between Mirabegron vs Tolterodine ER.|
1629192|NCT02138747|2992740|Superiority or Other (legacy)||LS Mean Difference|-2.89|Standard Error of the Mean|0.997||0.004|2-Sided|95.0|-4.86|-0.93||p-value based on the ANOVA model|ANOVA|||Tolerability score was analyzed using the ANOVA model (Model #1), with sequence group, study period, period-by-sequence interaction, gender and treatment group as factors, and subject-within-sequence as a random term. p-value based on the ANOVA model. Difference used mirabegron as the reference (difference =tolterodine ER –mirabegron). A negative difference indicates better reported tolerability with mirabegron than with tolterodine ER.|
1629193|NCT02138253|2992758|Superiority||Risk Difference (RD)|-7.9||||0.421|2-Sided|95.0|-28.8|13.1|||Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.|
1629194|NCT02138253|2992759|Superiority||Risk Difference (RD)|4.4||||0.658|2-Sided|95.0|-20.0|28.9|||Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.|
1629230|NCT02137512|2992879|Superiority|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629231|NCT02137512|2992880|Superiority|||||||0.68||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629195|NCT02138253|2992760|Superiority|For the primary efficacy analysis based on the Month 24 biopsy, subjects with a missing Month 24 biopsy had their Ishak fibrosis score imputed. Imputation of missing Ishak fibrosis scores was conducted using multiple imputation (MI). Results were imputed based on age, gender, baseline Ishak fibrosis score, and the Month 12 Ishak fibrosis score.|Risk Difference (RD)|2.9||||0.73|2-Sided|95.0|-20.5|26.4||Stratified by baseline Ishak Fibrosis Score strata (F2, F3+F4+F5, and F6).|Cochran-Mantel-Haenszel|||All screening and post-baseline biopsy data collected were used in the primary analysis, irrespective of the defined protocol visit window. Classification of the Ishak fibrosis score was summarized descriptively by treatment group at baseline, Month 12, and Month 24. Response at Months 12 and 24 were summarized descriptively by treatment group, along with exact (Clopper-Pearson) 95% confidence intervals (CIs). The risk difference between groups was also was provided with its 95% CI.|
1629196|NCT02138240|2992761|Other|Pre-post comparison of baseline median weight to median weight at 6-month follow up||||||0.21|||||||Wilcoxon signed rank sum||||
1629197|NCT02138240|2992764|Other|Pre-post comparison|||||<|0.001|||||||Wilcoxon signed rank sum||||
1629198|NCT02138227|2992768|Superiority or Other||||||<|0.01|||||||ANOVA|F (2, 1574)|||
1629199|NCT02138227|2992769|Superiority or Other||||||<|0.01|||||||ANOVA||||
1629200|NCT02138006|2992801|Superiority or Other|||||||0.3|||||||Log Rank||||
1629201|NCT02137785|2992849|Superiority or Other|||||||0.0001||||||Analysis uses observed data only. Missing data was not imputed except for subjects with missing CCR are classified as not having a CCR (ie non-responder).|Cochran-Mantel-Haenszel|CMH test stratified by analysis center|||
1629202|NCT02137785|2992850|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|linear mixed model with fixed effects for treatment group, time point, and treatment group by time point interaction|||
1629203|NCT02137785|2992851|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|linear mixed model with fixed effects for treatment group, time point, and treatment group by time point interaction|||
1629204|NCT02137785|2992852|Superiority or Other|||||||0.0001||||||Analysis uses observed data only. Missing data was not imputed except for subjects with missing CCR are classified as not having a CCR (ie non-responder).|Cochran-Mantel-Haenszel|CMH test stratified by analysis center||A hierarchical procedure was used to control the level of significance. If the primary analysis was sig (p≤0.05), then AKCR at Week 12 were to be compared. If this analysis was significant, then the AKCR at Week 8 were to be compared. If this analysis was significant, then the CCR at Week 8 was to be compared.|
1629205|NCT02137772|2992855|Superiority or Other (legacy)||||||<|0.0001||||||Nominal 2-sided p-value|Log Rank|The log rank test analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)|||
1629206|NCT02137772|2992856|Superiority or Other (legacy)||Risk Difference (RD)|-23.3|||<|0.0001|2-Sided|95.0|-32.3|-14.3||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)|||
1629207|NCT02137772|2992857|Superiority or Other (legacy)||Risk Difference (RD)|-31.0|||<|0.0001|2-Sided|95.0|-39.6|-22.4||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)|||
1629208|NCT02137772|2992858|Superiority or Other (legacy)||Risk Difference (RD)|-1.0||||0.2258|2-Sided|95.0|-3.5|1.5||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)|||
1629209|NCT02137772|2992859|Superiority or Other (legacy)||Risk Difference (RD)|-0.4||||0.4056|2-Sided|95.0|-4.0|3.2||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)|||
1629210|NCT02137772|2992860|Superiority or Other (legacy)||Risk Difference (RD)|-31.3|||<|0.0001|2-Sided|95.0|-39.9|-22.6||Nominal 1-sided p-value|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)|||
1629211|NCT02137772|2992861|Superiority or Other (legacy)||||||<|0.0001||||||Nominal 2-sided p-value|Log Rank|The log rank test was adjusted for sample size for each stratum (high or low risk for CMV reactivation)|||
1629212|NCT02137772|2992862|Superiority or Other (legacy)||Risk Difference (RD)|-23.5|||<|0.0001|2-Sided|95.0|-32.5|-14.6||A 1-sided p-value ≤0.0249 for the risk difference was used for declaring statistical significance|Mantel Haenszel|The Mantel Haenszel analysis was adjusted for sample size for each stratum (high or low risk for CMV reactivation)|||
1629213|NCT02137512|2992868|Superiority|||||||0.14||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629214|NCT02137512|2992869|Superiority|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629215|NCT02137512|2992870|Superiority|||||||0.01||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629216|NCT02137512|2992871|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629217|NCT02137512|2992872|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629218|NCT02137512|2992873|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629219|NCT02137512|2992874|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629220|NCT02137512|2992875|Superiority|||||||0.23||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629221|NCT02137512|2992876|Superiority|||||||0.25||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629222|NCT02137512|2992877|Superiority|||||||0.22||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629223|NCT02137512|2992877|Superiority|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629224|NCT02137512|2992877|Superiority|||||||0.67||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629225|NCT02137512|2992878|Superiority|||||||0.23||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629226|NCT02137512|2992878|Superiority|||||||0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629227|NCT02137512|2992878|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629234|NCT02137512|2992881|Superiority|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629235|NCT02137512|2992881|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629236|NCT02137512|2992881|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629237|NCT02137512|2992882|Superiority|||||||0.74||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629238|NCT02137512|2992882|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629239|NCT02137512|2992882|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629240|NCT02137512|2992883|Superiority|||||||0.86||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629241|NCT02137512|2992883|Superiority|||||||0.003||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629242|NCT02137512|2992883|Superiority|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629243|NCT02137512|2992884|Superiority|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629244|NCT02137512|2992884|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629245|NCT02137512|2992884|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629246|NCT02137512|2992885|Superiority|||||||0.39||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629247|NCT02137512|2992885|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629248|NCT02137512|2992885|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629249|NCT02137512|2992886|Superiority|||||||0.71||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629250|NCT02137512|2992886|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629251|NCT02137512|2992886|Superiority||||||<|0.003||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629252|NCT02137512|2992887|Superiority|||||||0.52||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629253|NCT02137512|2992887|Superiority|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629254|NCT02137512|2992887|Superiority|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629255|NCT02137512|2992888|Superiority|||||||0.05||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629256|NCT02137512|2992888|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629257|NCT02137512|2992888|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629258|NCT02137512|2992889|Superiority|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629259|NCT02137512|2992889|Superiority|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629260|NCT02137512|2992889|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629261|NCT02137512|2992890|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629262|NCT02137512|2992890|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629263|NCT02137512|2992890|Superiority||||||<|0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629264|NCT02137512|2992891|Superiority|||||||0.22||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629265|NCT02137512|2992891|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629266|NCT02137512|2992891|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629267|NCT02137512|2992892|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629268|NCT02137512|2992892|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629269|NCT02137512|2992892|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629270|NCT02137512|2992893|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629271|NCT02137512|2992893|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629272|NCT02137512|2992893|Superiority||||||<|0.05||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629273|NCT02137512|2992894|Superiority|||||||0.53||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629274|NCT02137512|2992894|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629275|NCT02137512|2992894|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 1 sided||||
1629276|NCT02137512|2992895|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629277|NCT02137512|2992895|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629278|NCT02137512|2992895|Superiority||||||<|0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629279|NCT02137512|2992896|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629280|NCT02137512|2992896|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629281|NCT02137512|2992896|Superiority||||||<|0.04||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629282|NCT02137512|2992897|Superiority|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1630049|NCT02123511|2994077|Superiority|||||||0.0422|||||||t-test, 1 sided||||
1629283|NCT02137512|2992897|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629284|NCT02137512|2992897|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629285|NCT02137512|2992898|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629286|NCT02137512|2992898|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629287|NCT02137512|2992898|Superiority||||||<|0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629288|NCT02137512|2992899|Superiority|||||||0.09||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629289|NCT02137512|2992899|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629290|NCT02137512|2992899|Superiority||||||<|0.006||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629291|NCT02137512|2992900|Superiority||||||>|0.99||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629292|NCT02137512|2992900|Superiority||||||>|0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629293|NCT02137512|2992900|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629294|NCT02137512|2992901|Superiority|||||||0.29||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629295|NCT02137512|2992901|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629296|NCT02137512|2992901|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629297|NCT02137512|2992902|Superiority|||||||0.61||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629298|NCT02137512|2992902|Superiority|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629299|NCT02137512|2992902|Superiority|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629300|NCT02137512|2992903|Superiority|||||||0.11||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629301|NCT02137512|2992903|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629302|NCT02137512|2992903|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629303|NCT02137512|2992904|Superiority|||||||0.26||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629304|NCT02137512|2992904|Superiority|||||||0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629305|NCT02137512|2992904|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629306|NCT02137512|2992905|Superiority|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629307|NCT02137512|2992905|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629308|NCT02137512|2992905|Superiority||||||<|0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629309|NCT02137512|2992906|Superiority|||||||0.12||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629310|NCT02137512|2992906|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629311|NCT02137512|2992906|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629312|NCT02137512|2992907|Superiority|||||||0.41||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629313|NCT02137512|2992907|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629314|NCT02137512|2992907|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629315|NCT02137512|2992908|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629316|NCT02137512|2992908|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629317|NCT02137512|2992908|Superiority||||||<|0.13||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629318|NCT02137512|2992909|Superiority|||||||0.52||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629319|NCT02137512|2992909|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629320|NCT02137512|2992909|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629321|NCT02137512|2992910|Superiority|||||||0.02||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629322|NCT02137512|2992910|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629323|NCT02137512|2992910|Superiority||||||<|0.005||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629324|NCT02137512|2992911|Superiority|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629325|NCT02137512|2992911|Superiority|||||||0.54||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629326|NCT02137512|2992911|Superiority|||||||0.07||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629327|NCT02137512|2992912|Superiority|||||||0.18||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629328|NCT02137512|2992912|Superiority|||||||0.03||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629329|NCT02137512|2992912|Superiority|||||||0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629330|NCT02137512|2992913|Superiority|||||||0.06||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629331|NCT02137512|2992913|Superiority|||||||0.14||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1630050|NCT02123511|2994078|Superiority|||||||0.1232|||||||t-test, 1 sided||||
1629332|NCT02137512|2992913|Superiority|||||||0.009||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629333|NCT02137512|2992914|Superiority|||||||0.49||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629334|NCT02137512|2992914|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629335|NCT02137512|2992914|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629336|NCT02137512|2992915|Superiority|||||||0.2||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629337|NCT02137512|2992915|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629338|NCT02137512|2992915|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629339|NCT02137512|2992916|Superiority|||||||0.91||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629340|NCT02137512|2992916|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629341|NCT02137512|2992916|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629342|NCT02137512|2992917|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629343|NCT02137512|2992917|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629344|NCT02137512|2992917|Superiority||||||<|0.1||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629345|NCT02137512|2992918|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629346|NCT02137512|2992918|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629347|NCT02137512|2992918|Superiority||||||<|0.002||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629348|NCT02137512|2992919|Superiority|||||||0.31||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629349|NCT02137512|2992919|Superiority||||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629350|NCT02137512|2992919|Superiority|No adjustments were made for multiple comparisons.|||||<|0.001||||||No adjustments were made for multiple comparisons.|t-test, 2 sided||||
1629351|NCT02137226|2992938|Non-Inferiority or Equivalence|The 95% Confidence Interval (CI) for ACR20 at Week 24, rounded to 1 decimal place, had to be entirely contained in the predefined equivalence region [-15.0%;+15.0%]|Difference in proportions|4.5|||||2-Sided|95.0|-3.4|12.5|||||Results from logistic regression model adjusted for treatment, prior exposure to a biologic agent (yes / no), Baseline DAS28 (ESR). Difference in ACR20 Response Rate (BI695501 – Humira, %) is presented.|The week 24 confidence interval for the estimated difference in proportion is produced using the cumulative distribution function method of Reeve|
1629352|NCT02137226|2992940|Non-Inferiority or Equivalence|Equivalence margin is not applicable|Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.17|0.23|||||Difference in least square means of BI 695501 – Humira is presented.|Results based on DAS28 (ESR) mean changes from Baseline after 24 weeks of treatment = overall mean + treatment group + Baseline DAS28 (ESR) + prior exposure to a biologic agent + random error.|
1629353|NCT02137226|2992940|Non-Inferiority or Equivalence|Equivalence margin is not applicable|Mean Difference (Final Values)|-0.1|||||2-Sided|90.0|-0.25|0.05|||||Difference in least square means of BI 695501 – Humira is presented.|Results based on DAS28 (ESR) mean changes from Baseline after 12 weeks of treatment = overall mean + treatment group + Baseline DAS28 (ESR) + prior exposure to a biologic agent + random error.|
1629354|NCT02137226|2992941|Non-Inferiority or Equivalence|The 90% Confidence Interval (CI) for ACR20 at Week 12, rounded to 1 decimal place, had to be entirely contained in the predefined equivalence region [-12.0%, 15.0%]|Difference in proportions|5.9|||||2-Sided|90.0|-0.9|12.7|||||Results from logistic regression model adjusted for treatment, prior exposure to a biologic agent (yes / no), Baseline DAS28 (ESR). Difference in ACR20 Response Rate (BI695501 – Humira, %) is presented.|The week 12 confidence interval for the estimated difference in proportion is produced using the cumulative distribution function method of Reeve|
1629355|NCT02136914|2992943|Superiority|||||||0.1071||||||Baseline to Week 24|Cochran-Mantel-Haenszel||||
1629356|NCT02136914|2992943|Superiority||||||<|0.0001||||||Baseline to Week 12|Cochran-Mantel-Haenszel||||
1629357|NCT02136914|2992944|Superiority||Least Squares Mean Difference|2.1|Standard Error of the Mean|3.58||0.5557|2-Sided|95.0|-5.0|9.2||Change from Baseline in MDS-UPDRS at Week 24.|Linear Mixed Model w/ Repeated Measures||||
1629358|NCT02136914|2992944|Superiority||Least Squares Mean Difference|-1.1|Standard Error of the Mean|2.74||0.6833|2-Sided|95.0|-6.6|4.3||Change from Baseline in MDS-UPDRS at Week 12.|Linear Mixed Model w/ Repeated Measures||||
1629359|NCT02136914|2992945|Superiority||Least Squares Mean Difference|-1.45|Standard Error of the Mean|0.526||0.0072|2-Sided|95.0|-2.49|-0.4||Change from Baseline in ON time with troublesome dyskinesia at Week 24.|Linear Mixed Model w/ Repeated Measures||||
1629360|NCT02136914|2992945|Superiority||Least Squares Mean Difference|-1.54|Standard Error of the Mean|0.508||0.0031|2-Sided|95.0|-2.55|-0.53||Change from Baseline in ON time with troublesome dyskinesia at Week 12.|Linear Mixed Model w/ Repeated Measures||||
1629361|NCT02136914|2992945|Superiority||Least Squares Mean Difference|-0.81|Standard Error of the Mean|0.389||0.0406|2-Sided|95.0|-1.58|-0.04||Change from Baseline in OFF time at Week 24.|Linear Mixed Model w/ Repeated Measures||||
1629362|NCT02136914|2992945|Superiority||Least Squares Mean Difference|-0.9|Standard Error of the Mean|0.373||0.0171|2-Sided|95.0|-1.64|-0.16||Change from Baseline in OFF time at Week 12.|Linear Mixed Model w/ Repeated Measures||||
1629363|NCT02136914|2992945|Superiority||Least Squares Mean Difference|2.22|Standard Error of the Mean|0.634||0.0007|2-Sided|95.0|0.96|3.47||Change from Baseline in ON time without troublesome dyskinesia at Week 24.|Linear Mixed Model w/ Repeated Measures||||
1629364|NCT02136914|2992945|Superiority||Least Squares Mean Difference|2.74|Standard Error of the Mean|0.612|<|0.0001|2-Sided|95.0|1.53|3.96||Change from Baseline in ON time without troublesome dyskinesia at Week 12.|Linear Mixed Model w/ Repeated Measures||||
1630137|NCT02120950|2994310|Superiority or Other||Mean Difference (Net)|-0.7||||0.548|2-Sided|95.0|-2.9|1.6|||ANCOVA||||
1629365|NCT02136914|2992946|Superiority||Least Squares Mean Difference|-9.3|Standard Error of the Mean|2.7||0.0008|2-Sided|95.0|-14.7|-4.0|||Linear Mixed Model w/ Repeated Measures||||
1629366|NCT02136914|2992947|Superiority||Least Squares Mean Difference|-7.9|Standard Error of the Mean|2.3||0.0009|2-Sided|95.0|-12.5|-3.3|||Linear Mixed Model w/ Repeated Measures|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||46 subjects per treatment arm provided 90% power using a 2-sided test at 5% significance.|
1629367|NCT02136680|2992956|Superiority|Change in Palliative Outcomes from First Follow-up to Second Follow-up: Intervention Group vs. Control Group|Regression Coefficient|0.165||||0.008|2-Sided||||||Regression, Linear||||
1629368|NCT02136680|2992956|Superiority||Regression Coefficient|0.037||||0.561|2-Sided||||||Regression, Linear|||Change in Palliative Outcomes from Baseline to Second Follow-up: Intervention Group vs. Control Group|
1629369|NCT02136680|2992956|Superiority||Regression Coefficient|-0.072||||0.213|2-Sided||||||Regression, Linear|||Change in Palliative Outcomes from Baseline to First Follow-up: Intervention Group vs. Control Group|
1629370|NCT02136680|2992957|Superiority||Regression Coefficient|0.051||||0.362|2-Sided||||||Regression, Linear|||Change in Summary QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Group|
1629371|NCT02136680|2992957|Superiority||Regression Coefficient|0.137||||0.018|2-Sided||||||Regression, Linear|||Change in Summary QOL from Baseline to Second Follow-up: Intervention Group vs. Control Group|
1629372|NCT02136680|2992957|Superiority||Regression Coefficient|-0.015||||0.774|2-Sided||||||Regression, Linear|||Change in Summary QOL from Baseline to First Follow-up|
1629373|NCT02136680|2992957|Superiority||Regression Coefficient|0.048||||0.454|2-Sided||||||Regression, Linear|||Change in Global QOL from First Follow-up to Second Follow-up: Intervention Group vs. Control Group|
1629374|NCT02136680|2992957|Superiority||Regression Coefficient|0.143||||0.021|2-Sided||||||Regression, Linear|||Change in Global QOL from Baseline to Second Follow-up: Intervention Group vs. Control Group|
1629375|NCT02136680|2992957|Superiority||Regression Coefficient|-0.003||||0.959|2-Sided||||||Regression, Linear|||Change in Global QOL from Baseline to First Follow-up: Intervention Group vs. Control Group|
1629376|NCT02136680|2992958|Superiority||Regression Coefficient|-0.003||||0.347|2-Sided||||||Regression, Linear|||Change in Self-Esteem from First Follow-up to Second Follow-up: Intervention Group vs. Control Group|
1629377|NCT02136680|2992958|Superiority||Regression Coefficient|0.119||||0.022|2-Sided||||||Regression, Linear|||Change in Self-Esteem from Baseline to Second Follow-up: Intervention Group vs. Control Group|
1629378|NCT02136680|2992958|Superiority||Regression Coefficient|0.046||||0.4|2-Sided||||||Regression, Linear|||Change in Self-Esteem from Baseline to First Follow-up: Intervention Group vs. Control Group|
1629379|NCT02135861|2992990|Other||Mean Difference (Final Values)|-0.0029||||0.9379|2-Sided|95.0|-0.0789|0.0731||estimates of right lung basal-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629380|NCT02135861|2992990|Other||Mean Difference (Final Values)|-0.0249||||0.4806|2-Sided|95.0|-0.0964|0.0466||estimates of right lung apical-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629381|NCT02135861|2992990|Other||Mean Difference (Final Values)|-0.0125||||0.6793|2-Sided|95.0|-0.0742|0.0491||estimates of left lung basal-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629382|NCT02135861|2992990|Other||Mean Difference (Final Values)|-0.0159||||0.5472|2-Sided|95.0|-0.0693|0.0375||estimates of left lung apical-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629383|NCT02135861|2992990|Other||Mean Difference (Final Values)|-0.0188||||0.597|2-Sided|95.0|-0.0909|0.0533||estimates of right lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629384|NCT02135861|2992990|Other||Mean Difference (Net)|-0.0201||||0.4531|2-Sided|95.0|-0.0744|0.0342||estimates of left lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629385|NCT02135861|2992990|Other||Mean Difference (Final Values)|-0.0267||||0.3682|2-Sided|95.0|-0.0866|0.0332||estimates of total lung-Post-excercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629386|NCT02135861|2992990|Other||Mean Difference (Final Values)|-0.0413||||0.3408|2-Sided|95.0|-0.1286|0.0461||estimates of right lung basal-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629387|NCT02135861|2992990|Other||Mean Difference (Final Values)|-0.0506||||0.1848|2-Sided|95.0|-0.1269|0.0257||estimates of right lung apical-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629388|NCT02135861|2992990|Other||Mean Difference (Final Values)|-0.0078||||0.8427|2-Sided|95.0|-0.0879|0.0722||estimates of left lung basal-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629389|NCT02135861|2992990|Other||Mean Difference (Final Values)|-0.0603||||0.1307|2-Sided|95.0|-0.1398|0.0191||estimates of left lung apical-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629390|NCT02135861|2992990|Other||Mean Difference (Final Values)|-0.0515||||0.2072|2-Sided|95.0|-0.1334|0.0303||estimates of right lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629391|NCT02135861|2992990|Other||Mean Difference (Final Values)|-0.0423||||0.2704|2-Sided|95.0|-0.1196|0.0349||estimates of left lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629392|NCT02135861|2992990|Other||Mean Difference (Final Values)|-0.0524||||0.173|2-Sided|95.0|-0.1292|0.0244||estimates of total lung-Pre-exercise|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629393|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.1458||||0.0052||95.0|0.0475|0.2442||estimates of right lung basal-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629394|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.1111||||0.025|2-Sided|95.0|0.0151|0.2071||estimates of right lung apical-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629395|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.2137|||<|0.0001|2-Sided|95.0|0.1266|0.3008||estimates of left lung basal-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629396|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.1464|||<|0.0002|2-Sided|95.0|0.0774|0.2153||estimates of left lung apical-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629397|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.126|||<|0.0114|2-Sided|95.0|0.0308|0.2212||estimates of right lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629398|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.1776|||<|0.0001|2-Sided|95.0|0.1057|0.2496||estimates of left lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629399|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.1428|||<|0.0015|2-Sided|95.0|0.0598|0.2259||estimates of total lung-Post-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629400|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.1194|||<|0.015|2-Sided|95.0|0.0251|0.2137||estimates of right lung basal-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629401|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.0956|||<|0.0658|2-Sided|95.0|-0.0067|0.1979||estimates of right lung apical-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629402|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.1776|||<|0.0002|2-Sided|95.0|0.0917|0.2635||estimates of left lung basal-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629403|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.1145|||<|0.0158|2-Sided|95.0|0.0235|0.2056||estimates of left lung apical-Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629404|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.1067|||<|0.0328|2-Sided|95.0|0.0094|0.204||estimates of right lung- Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629405|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.1366|||<|0.0026|2-Sided|95.0|0.0523|0.2209||estimates of left lung- Pre-exercise|ANOVA|estimates of left lung- Pre-exercise|||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629406|NCT02135861|2992991|Other||Mean Difference (Final Values)|0.1148|||<|0.0156|2-Sided|95.0|0.0236|0.2061||estimates of total lung- Pre-exercise|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629407|NCT02135861|2992992|Other||Mean Difference (Final Values)|-0.0118||||0.7936|2-Sided|95.0|-0.1036|0.08||estimates of right lung basal|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629408|NCT02135861|2992992|Other||Mean Difference (Final Values)|-0.0362||||0.4592|2-Sided|95.0|-0.1355|0.0631||estimates of right lung apical|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629409|NCT02135861|2992992|Other||Mean Difference (Final Values)|0.0396||||0.2912|2-Sided|95.0|-0.036|0.1153||estimates of left lung basal|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629410|NCT02135861|2992992|Other||Mean Difference (Final Values)|0.0005||||0.9899|2-Sided|95.0|-0.0738|0.0747||estimates of left lung apical|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629411|NCT02135861|2992992|Other||Mean Difference (Final Values)|-0.0258||||0.5778|2-Sided|95.0|-0.1201|0.0684||estimates of right lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629412|NCT02135861|2992992|Other||Mean Difference (Final Values)|0.0136||||0.6992|2-Sided|95.0|-0.058|0.0852||estimates of left lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629413|NCT02135861|2992992|Other||Mean Difference (Final Values)|-0.0137||||0.7381|2-Sided|95.0|-0.0968|0.0695||estimates of total lung|ANOVA||||Ktrans was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629414|NCT02135861|2992993|Other||Mean Difference (Final Values)|0.1748||||0.0064|2-Sided|95.0|0.0535|0.2961||estimates of right lung basal|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629415|NCT02135861|2992993|Other||Mean Difference (Final Values)|0.136||||0.0159|2-Sided|95.0|0.0276|0.2443||estimates of right lung apical|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629416|NCT02135861|2992993|Other||Mean Difference (Final Values)|0.1999||||0.001|2-Sided|95.0|0.0894|0.3103||estimates of left lung basal|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629417|NCT02135861|2992993|Other||Mean Difference (Final Values)|0.1764||||0.0007|2-Sided|95.0|0.0823|0.2704||estimates of left lung apical|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629418|NCT02135861|2992993|Other||Mean Difference (Final Values)|0.1565||||0.0093|2-Sided|95.0|0.0419|0.2711||estimates of right lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629419|NCT02135861|2992993|Other||Mean Difference (Final Values)|0.1825||||0.0007|2-Sided|95.0|0.0855|0.2795||estimates of left lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629420|NCT02135861|2992993|Other||Mean Difference (Final Values)|0.16||||0.0029|2-Sided|95.0|0.06|0.26||estimates of total lung|ANOVA||||Ve was fitted using a repeat measure ANOVA model with terms including participant population (HF or HV), visit (i.e. sessions), interaction of participant population and visit, with participant ID as block of the repeat factor
1629421|NCT02135614|2993029|Superiority|||||||0.004||||||P-value from the negative binomial model comparing the rate ratio between treatment groups, adjusted for the stratification factor.|Negative Binomial Model||||
1629422|NCT02135614|2993030|Superiority|||||||0.39||||||P-value was calculated from the negative binomial model with the stratification factor as covariate.|Negative Binomial Model||||
1629423|NCT02135614|2993031|Superiority||Treatment difference|0.08||||0.046|2-Sided|95.0|0.0|0.16||P-value was calculated from the ANCOVA model including the baseline value, CFS score and stratification factor as covariates.|ANCOVA||||
1629424|NCT02135614|2993032|Superiority||Treatment difference|0.12||||0.46|2-Sided|95.0|-0.2|0.43||P-value was calculated from the ANCOVA model including baseline values, Clinical Frailty Scale (CFS) score, and stratification factor as covariates.|ANCOVA||||
1629425|NCT02135146|2993066|Superiority|||||||0.07|||||||t-test, 2 sided||||
1629426|NCT02135146|2993066|Superiority|||||||0.31|||||||t-test, 2 sided||||
1629427|NCT02135107|2993069|Superiority||Group difference|0.0|||=|0|2-Sided|95.0|-3.5|3.5||P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.|Chi-squared||Group difference (percentage of participants) = Arm D (percentage of participants) - Arm C (percentage of participants) 95% CI was calculated based on normal approximation.||
1629428|NCT02135107|2993072|Superiority||Group difference|-15.2|||<|0.001|2-Sided|95.0|-23.5|-6.8|||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.|Group difference (percentage of participants) = Arm D (percentage of participants) - Arm C (percentage of participants) 95% CI was calculated based on normal approximation.||
1629429|NCT02135107|2993073|Superiority||Hazard Ratio (HR)|0.34|||<|0.001|2-Sided|95.0|0.23|0.49|||Log Rank||||
1629430|NCT02135107|2993074|Superiority||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.||Comparison at Week 24|
1629431|NCT02135107|2993074|Superiority||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at a two-sided significance level of alpha = 0.05.||Comparison at Week 12|
1629432|NCT02135107|2993075|Superiority or Other||||||<|0.001|||||||Chi-squared|P-value was calculated using chi-square test at two-sided significance level of alpha = 0.05.|||
1629433|NCT02135029|2993088|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.4|-0.3|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 24|
1629434|NCT02135029|2993088|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.5|-0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629435|NCT02135029|2993089|Superiority or Other||LS Mean Difference|-2.1|Standard Error of the Mean|0.16|||2-Sided|95.0|-2.4|-1.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 24|
1629436|NCT02135029|2993089|Superiority or Other||LS Mean Difference|-2.4|Standard Error of the Mean|0.15|||2-Sided|95.0|-2.7|-2.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629437|NCT02135029|2993090|Superiority or Other||LS Mean Difference|-6.6|Standard Error of the Mean|1.06|||2-Sided|95.0|-8.7|-4.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629438|NCT02135029|2993091|Superiority or Other||LS Mean Difference|-59.2|Standard Error of the Mean|3.46|||2-Sided|95.0|-66.0|-52.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629439|NCT02135029|2993093|Superiority or Other||LS Mean Difference|-103.6|Standard Error of the Mean|5.56|||2-Sided|95.0|-114.6|-92.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629440|NCT02135029|2993094|Superiority or Other||LS Mean Difference|5.9|Standard Error of the Mean|1.11|||2-Sided|95.0|3.7|8.0|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629441|NCT02135029|2993095|Superiority or Other||LS Mean Difference|-98.7|Standard Error of the Mean|5.67|||2-Sided|95.0|-109.9|-87.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629442|NCT02135029|2993096|Superiority or Other||LS Mean Difference|-93.8|Standard Error of the Mean|4.93|||2-Sided|95.0|-103.5|-84.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629443|NCT02135029|2993097|Superiority or Other||LS Mean Difference|-9.7|Standard Error of the Mean|5.14|||2-Sided|95.0|-19.8|0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 24|
1629444|NCT02135029|2993097|Superiority or Other||LS Mean Difference|-14.3|Standard Error of the Mean|4.67|||2-Sided|95.0|-23.5|-5.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629445|NCT02135029|2993098|Superiority or Other||LS Mean Difference|6.5|Standard Error of the Mean|2.07|||2-Sided|95.0|2.4|10.5|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 24|
1629446|NCT02135029|2993098|Superiority or Other||LS Mean Difference|4.7|Standard Error of the Mean|2.02|||2-Sided|95.0|0.8|8.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629447|NCT02135029|2993099|Superiority or Other||LS Mean Difference|5.6|Standard Error of the Mean|2.09|||2-Sided|95.0|1.5|9.7|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 24|
1629448|NCT02135029|2993099|Superiority or Other||LS Mean Difference|6.1|Standard Error of the Mean|2.0|||2-Sided|95.0|2.2|10.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629449|NCT02135029|2993100|Superiority or Other||LS Mean Difference|-9.7|Standard Error of the Mean|5.14|||2-Sided|95.0|-19.8|0.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 24|
1629450|NCT02135029|2993100|Superiority or Other||LS Mean Difference|-14.3|Standard Error of the Mean|4.67|||2-Sided|95.0|-23.5|-5.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629451|NCT02135029|2993101|Superiority or Other||LS Mean Difference|-44.8|Standard Error of the Mean|3.33|||2-Sided|95.0|-51.3|-38.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 24|
1629452|NCT02135029|2993102|Superiority or Other||LS Mean Difference|11.5|Standard Error of the Mean|2.47|||2-Sided|95.0|6.7|16.4|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 24|
1629453|NCT02135029|2993102|Superiority or Other||LS Mean Difference|12.4|Standard Error of the Mean|2.34|<|0.001|2-Sided|95.0|7.8|17.0|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629454|NCT02135029|2993103|Superiority or Other||LS Mean Difference|-17.4|Standard Error of the Mean|6.21|||2-Sided|95.0|-29.6|-5.1|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 24|
1629455|NCT02135029|2993103|Superiority or Other||LS Mean Difference|-23.3|Standard Error of the Mean|6.32|<|0.001|2-Sided|95.0|-35.7|-10.8|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629941|NCT02128490|2993786|Superiority or Other||Difference in Proportions|21.4||||0.069|2-Sided|95.0|-0.3|43.1|||Fisher Exact||||
1629456|NCT02135029|2993104|Superiority or Other||LS Mean Difference|-41.8|Standard Error of the Mean|3.02|||2-Sided|95.0|-47.7|-35.8|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 24|
1629457|NCT02135029|2993104|Superiority or Other||LS Mean Difference|-51.2|Standard Error of the Mean|2.61|<|0.001|2-Sided|95.0|-56.3|-46.0|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629458|NCT02135029|2993105|Superiority or Other||LS Mean Difference|-39.3|Standard Error of the Mean|3.1|||2-Sided|95.0|-45.4|-33.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 24|
1629459|NCT02135029|2993105|Superiority or Other||LS Mean Difference|-46.5|Standard Error of the Mean|2.72|<|0.001|2-Sided|95.0|-51.9|-41.1|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629460|NCT02135029|2993106|Superiority or Other||LS Mean Difference|-31.0|Standard Error of the Mean|2.47|||2-Sided|95.0|-35.9|-26.2|||||LS-mean differences, associated 95% CI, for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 24|
1629461|NCT02135029|2993106|Superiority or Other||LS Mean Difference|-38.4|Standard Error of the Mean|2.13|<|0.001|2-Sided|95.0|-42.6|-34.2|||MMRM||LS-mean differences, associated 95% CI, and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group* visit interaction, baseline value, baseline value* visit* group interaction, country.|Week 12|
1629462|NCT02135029|2993107|Superiority or Other||Least Square (LS) Mean Difference|-54.5|Standard Error of the Mean|2.82|<|0.001|2-Sided|95.0|-60.1|-49.0|||MMRM|Mixed Model Repeated Measures (MMRM)|LS-mean differences,associated 95% confidence interval (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit,treatment group*visit interaction,baseline value, baseline value*visit*group interaction, country.||
1629463|NCT02134925|2993138|Superiority|||||||0.0001|||||||Fisher Exact||||
1629464|NCT02134925|2993143|Superiority|||||||0.0004|||||||Wilcoxon (Mann-Whitney)||||
1629465|NCT02134587|2993153|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1629466|NCT02134587|2993154|Superiority or Other|||||||1e-05|||||||Wilcoxon (Mann-Whitney)||||
1629467|NCT02133664|2993240|Superiority||Mean Difference (Final Values)|1.14|Standard Error of the Mean|1.57||0.05|2-Sided|95.0|-2.03|4.32|||t-test, 2 sided|||With the initial sample size plan of 53 subjects, we expect an 80% power to detect a significant difference in PASAT score with a mean difference of 8.3 points between the treatment and placebo group.|
1629468|NCT02132936|2993295|Superiority or Other (legacy)||||||=|0|||||||ANCOVA|||Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.|
1629469|NCT02132936|2993296|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Mean change in itch adjusted for pooled centre, baseline PGA and baseline itch. Multiple imputation used for missing data.|
1629470|NCT02132936|2993297|Superiority or Other (legacy)||||||<|0.001|||||||Log Rank||||
1629471|NCT02132936|2993298|Superiority or Other (legacy)||Odds Ratio (OR)|2.18|||=|0|2-Sided|95.0|1.37|3.47|||Mantel Haenszel|||"Mantel-Haenszel odds of having PASI 75 in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.~Multiple imputation was used to handle missing data."|
1629472|NCT02132936|2993299|Superiority or Other (legacy)||Odds Ratio (OR)|2.55|||<|0.001|2-Sided|95.0|1.46|4.46|||Mantel Haenszel|||"Mantel-Haenszel odds of treatment success in LEO 90100 group relative to calcipotriol BDP gel group, adjusted for pooled centre and baseline PGA.~Multiple imputation was used to handle missing PGA values."|
1629473|NCT02132767|2993325|Superiority or Other|||||||0.73|||||||Regression, Poisson||||
1629474|NCT02132767|2993326|Superiority or Other|||||||0.82|||||||Wilcoxon (Mann-Whitney)||||
1629475|NCT02132767|2993327|Superiority or Other|||||||0.88|||||||Wilcoxon (Mann-Whitney)||||
1629476|NCT02132767|2993328|Superiority or Other|||||||0.03|||||||Chi-squared||||
1629477|NCT02132767|2993329|Superiority or Other|||||||0.71|||||||Chi-squared||||
1629478|NCT02132767|2993330|Superiority or Other|||||||0.14|||||||Chi-squared||||
1629479|NCT02132767|2993331|Superiority or Other|||||||0.003|||||||Log Rank||||
1629480|NCT02132767|2993332|Superiority or Other|||||||0.76|||||||Wilcoxon (Mann-Whitney)||||
1629481|NCT02131662|2993393|Superiority or Other||Percentage difference|28.28|||||2-Sided|95.0|15.92|41.5||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.|
1629482|NCT02131662|2993393|Superiority or Other||Percentage difference|54.01|||||2-Sided|95.0|40.41|66.95||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.|
1629483|NCT02131662|2993393|Superiority or Other||Percentage difference|52.37|||||2-Sided|95.0|38.8|65.42||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.|
1629484|NCT02131662|2993393|Superiority or Other||Percentage difference|58.28|||||2-Sided|95.0|44.55|70.94||||||The placebo-adjusted amenorrhea rate was summarized by dose with unconditional 2-sided 95% confidence intervals for each active treatment group. This unconditional confidence interval was calculated by inverting 2 separate one-sided tests of half the nominal significance level each.|
1629525|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|1.01||||0.495|2-Sided|95.0|0.42|2.4||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.||
1629485|NCT02131532|2993404|Superiority or Other||Mean Difference (Final Values)|-14.576|Standard Error of the Mean|3.691||0.006|2-Sided|95.0|-23.304|-5.847||The critical level was adjusted for the multiple comparisons for the eight subscales of the Stroke Impact Scale|t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in social activity scores between baseline and three-month assessments|
1629486|NCT02131532|2993405|Superiority or Other||Mean Difference (Final Values)|-1.875|Standard Error of the Mean|3.264||0.58|2-Sided|95.0|-9.594|5.844||The critical level was adjusted for the multiple comparisons for the eight subscales of the Stroke Impact Scale|t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in hand function scores between baseline and three-month assessments|
1629487|NCT02131532|2993406|Superiority or Other||Mean Difference (Final Values)|-3.821|Standard Error of the Mean|1.382||0.03|2-Sided|95.0|-7.091|-0.551|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in mobility scores between baseline and three-month assessments|
1629488|NCT02131532|2993407|Superiority or Other||Mean Difference (Final Values)|-2.5|Standard Error of the Mean|1.25||0.09|2-Sided|95.0|-5.455|0.455|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in daily activities scores between baseline and three-month assessments|
1629489|NCT02131532|2993408|Superiority or Other||Mean Difference (Final Values)|-7.142|Standard Error of the Mean|3.696||0.1|2-Sided|95.0|-15.883|1.598|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in communication scores between baseline and three-month assessments|
1629490|NCT02131532|2993409|Superiority or Other||Mean Difference (Final Values)|-18.403|Standard Error of the Mean|5.168||0.009|2-Sided|95.0|-30.624|-6.183|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in emotion scores between baseline and three-month assessments|
1629491|NCT02131532|2993410|Superiority or Other||Mean Difference (Final Values)|-2.105|Standard Error of the Mean|2.378||0.009|2-Sided|95.0|-7.729|3.519|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in memory and thinking scores between baseline and three-month assessments|
1629492|NCT02131532|2993411|Superiority or Other||Mean Difference (Final Values)|-0.781|Standard Error of the Mean|5.594||0.89|2-Sided|95.0|-14.01|12.448|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in physical strength scores between baseline and three-month assessments|
1629493|NCT02131532|2993412|Superiority or Other||Mean Difference (Final Values)|-13.875|Standard Error of the Mean|5.03||0.03|2-Sided|95.0|-25.769|-1.981|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in scores of general rating of recovery between baseline and three-month assessments|
1629494|NCT02131532|2993413|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.313||0.45|2-Sided|95.0|-0.991|0.491|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in independence scores between baseline and three-month assessments|
1629495|NCT02131532|2993414|Superiority or Other||Mean Difference (Final Values)|2.625|Standard Error of the Mean|1.401||0.1|2-Sided|95.0|-0.687|5.937|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in depression scores between baseline and three-month assessments|
1629496|NCT02131532|2993415|Superiority or Other||Mean Difference (Final Values)|9.25|Standard Error of the Mean|3.321||0.03|2-Sided|95.0|1.398|17.102|||t-test, 2 sided|Paired t-test|P values below 0.05 are considered statistically significant in this study.|Null hypothesis: there was no difference in fatigue scores between baseline and three-month assessments|
1629497|NCT02131324|2993449|Equivalence|Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.||||||0.086|||||||ANOVA|||Two-sided hypothesis testing was conducted for all the tests. Resulting p-values less than 0.05 were considered statistically significant unless noted otherwise. No adjustments of p values were made for multiple comparisons.|
1629498|NCT02131272|2993463|Non-Inferiority or Equivalence|Non-inferiority was considered fulfilled if the upper bound of the two-sided 95% confidence interval for the difference between detemir and NPH was below or equal to 0.4%. The sample size was set to ensure 80% power for the full analysis set (FAS). However, efficacy conclusions cannot be drawn from the analysis due to low number of subjects included in the trial.|Least squares mean difference|0.17||||0.3075|2-Sided|95.0|-0.74|1.09||p value is reported for 1 sided test|Mixed Models Analysis|||HbA1c measurements were analysed with a mixed model for repeated measurements with an unstructured covariance matrix. The model included treatment, visit, age group, prior antidiabetic therapy and interaction between prior antidiabetic therapy and age group as fixed factors and the HbA1c baseline value as covariate. Interactions between visit and all factors and covariates were also included in the model.|
1629499|NCT02131233|2993476|Superiority or Other||Mean Difference (Final Values)|-0.6|||||2-Sided|95.0|-32.8|31.6|||||Reformulated Raltegravir minus Raltegravir|The 95% CI for mean difference in CD4 change was based on t-distribution.|
1629500|NCT02131233|2993477|Superiority or Other||Mean Difference (Final Values)|-2.1|||||2-Sided|95.0|-30.9|26.7|||||Reformulated Raltegravir minus Raltegravir|The 95% CI for mean difference in CD4 change was based on t-distribution.|
1629501|NCT02131233|2993478|Non-Inferiority or Equivalence|Reformulated Raltegravir is concluded non-inferior to Raltegravir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Estimated Difference|1.449|||||2-Sided|95.0|-4.41|7.308|||||Reformulated Raltegravir minus Raltegravir|The 95% Confidence Interval (CI) for the treatment differences in percent response were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA <=100,000 copies/mL or HIV-1 RNA >100,000 copies/mL)|
1629942|NCT02128490|2993786|Superiority or Other||Difference in Proportions|55.3|||<|0.001|2-Sided|95.0|39.5|71.1|||Fisher Exact||||
1629502|NCT02131233|2993479|Non-Inferiority or Equivalence|Reformulated Raltegravir is concluded non-inferior to Raltegravir if the lower bound of the 95% CI for the difference in percent response is above -10 percentage points.|Estimated Difference|0.51|||||2-Sided|95.0|-4.204|5.223|||||Reformulated Raltegravir minus Raltegravir|The 95% Confidence Interval (CI) for the treatment differences in percent response were calculated using stratum-adjusted Mantel-Haenszel method with the difference weighted by the harmonic mean of sample size per arm for each stratum (screening HIV-1 RNA <=100,000 copies/mL or HIV-1 RNA >100,000 copies/mL)|
1629503|NCT02131064|2993492|Superiority||Difference in Deterioration|-28.88|||||2-Sided|95.0|-37.95|-19.8||||||This is the statistical analysis for role functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.|
1629504|NCT02131064|2993492|Superiority||Difference in Deterioration|-32.54|||||2-Sided|95.0|-41.74|-23.34||||||This is the statistical analysis for physical functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.|
1629505|NCT02131064|2993492|Superiority||Difference in Deterioration|-16.63|||||2-Sided|95.0|-26.32|-6.94||||||This is the statistical analysis for cognitive functioning. 95% CI for the difference in clinically meaningful deterioration in function subscales between treatment arms was calculated using normal approximation.|
1629506|NCT02131064|2993503|Superiority||Hazard Ratio (HR)|0.6||||0.0001|2-Sided|95.0|0.46|0.78|||Log Rank|Log Rank was used and stratified by local hormone receptor status and clinical stage at presentation.||Stratified cox proportional hazards regression model was used to estimate Hazard Ratio and CI. Stratification by hormonal receptor status and clinical stage at presentation (stratification factors).|
1629507|NCT02131064|2993504|Superiority||Difference in Deterioration|-24.58|||||2-Sided|95.0|-33.98|-15.19||||||95% CI for the difference in clinically meaningful deterioration in GHS/QoL score between treatment arms was calculated using normal approximation.|
1629508|NCT02131064|2993507|Superiority||Hazard Ratio (HR)|1.11|||||2-Sided|95.0|0.52|2.4|||||||
1629509|NCT02131064|2993508|Superiority||Hazard Ratio (HR)|2.61||||0.0027|2-Sided|95.0|1.36|4.98|||Log Rank|The Log Rank was used and stratified by local hormone receptor status and clinical stage at presentation.|||
1629510|NCT02131064|2993509|Superiority||Difference in BCS rate|-10.84||||0.0228|2-Sided|95.0|-20.21|-1.47|||Cochran-Mantel-Haenszel Chi-Square|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||95% CI for the difference in BCS rate between treatment arms was calculated using normal approximation.|
1629511|NCT02131064|2993510|Superiority||Hazard Ratio (HR)|1.21||||0.7557|2-Sided|95.0|0.37|3.96|||Cochran-Mantel-Haenszel Chi-Square Test|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.|||
1629512|NCT02131064|2993511|Superiority||Difference in tpCR rate|-11.71||||0.0126|2-Sided|95.0|-20.95|-2.48||Threshold for significance at 5%|Cochran-Mantel-Haenszel Chi-Square|The Cochran-Mantel-Haenszel Chi-square test was used and stratified by local hormone receptor status and clinical stage at presentation.||95% CI for the difference in tPCR rates between treatment arms was calculated using normal approximation.|
1629513|NCT02130986|2993522|Superiority||Risk Difference (RD)|-4.6|||||2-Sided|95.0|-12.2|30.0|||||||
1629514|NCT02130986|2993523|Non-Inferiority|Procalcitonin algorithm implementation increases or does not change the proportion of subjects who experience a composite endpoint of adverse outcomes by Day 30. The prespecified noninferiority margin is 4.5 percentage.|Risk Difference (RD)|-0.015|||<|0.001|2-Sided||||||Chi-squared||||
1629515|NCT02130986|2993524|Superiority||Mean Difference (Net)|-0.05||||0.87|2-Sided||||||t-test, 2 sided||||
1629516|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.53||||0.911|2-Sided|95.0|0.21|1.37||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.||
1629517|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.78||||0.698|2-Sided|95.0|0.21|2.9||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.||
1629518|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|1.03||||0.472|2-Sided|95.0|0.39|2.74||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.||
1629519|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|1.1||||0.447|2-Sided|95.0|0.27|4.44||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.||
1629520|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|1.37||||0.24|2-Sided|95.0|0.55|3.45||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.||
1629521|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio9|2.18||||0.109|2-Sided|95.0|0.62|7.95||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.||
1629522|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.74||||0.741|2-Sided|95.0|0.29|1.9||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.||
1629523|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.87||||0.646|2-Sided|95.0|0.4|1.86||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.||
1629524|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.82||||0.647|2-Sided|95.0|0.28|2.37||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.||
1629943|NCT02128490|2993786|Superiority or Other||Difference in Proportions|53.8|||<|0.001|2-Sided|95.0|38.2|69.5|||Fisher Exact||||
1629526|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.46||||0.94|2-Sided|95.0|0.17|1.23||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.||
1629527|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio9|1.01||||0.489|2-Sided|95.0|0.45|2.26||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.||
1629528|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|1.18||||0.353|2-Sided|95.0|0.48|2.88||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 2000ug/placebo for day 14.||
1629529|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.81||||0.698|2-Sided|95.0|0.35|1.85||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 2000ug/placebo for day 7.||
1629530|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|1.21||||0.334|2-Sided|95.0|0.49|3.04||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 1000ug/placebo for day 14.||
1629531|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.76||||0.744|2-Sided|95.0|0.32|1.77||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 1000ug/placebo for day 7.||
1629532|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|1.0||||0.5|2-Sided|95.0|0.42|2.35||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 700ug/placebo for day 14.||
1629533|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio9|1.26||||0.281|2-Sided|95.0|0.56|2.82||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 700ug/placebo for day 7.||
1629534|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.43||||0.953|2-Sided|95.0|0.16|1.16||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.||
1629535|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.46||||0.873|2-Sided|95.0|0.12|1.81||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.||
1629536|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.43||||0.952|2-Sided|95.0|0.16|1.17||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.||
1629537|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.35||||0.932|2-Sided|95.0|0.09|1.42||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.||
1629538|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|1.05||||0.463|2-Sided|95.0|0.38|2.86||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.||
1629539|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.47||||0.86|2-Sided|95.0|0.11|1.93||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of TNFalpha concentrations at Day 7. This is the baseline corrected ratio of 100ug/placebo for day 7.||
1629540|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.55||||0.892|2-Sided|95.0|0.21|1.43||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.||
1629541|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.58||||0.919|2-Sided|95.0|0.27|1.26||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.||
1629542|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.64||||0.797|2-Sided|95.0|0.22|1.87||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.||
1629543|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.71||||0.783|2-Sided|95.0|0.29|1.7||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.||
1629544|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.91||||0.578|2-Sided|95.0|0.33|2.47||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of IL8 concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.||
1629545|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.81||||0.702|2-Sided|95.0|0.35|1.81||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of IL8 concentrations at Day 7.This is the baseline corrected ratio of 100ug/placebo for day 7.||
1629546|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.64||||0.841|2-Sided|95.0|0.27|1.56||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 500ug/placebo for day 14.||
1629547|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.75||||0.764|2-Sided|95.0|0.33|1.71||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 500ug/placebo for day 7.||
1629548|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.81||||0.69|2-Sided|95.0|0.33|1.97||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 200ug/placebo for day 14.||
1629944|NCT02128490|2993787|Superiority or Other||Difference in Proportions|4.3||||0.815|2-Sided|95.0|-17.9|26.4|||Fisher Exact||||
1629549|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.68||||0.823|2-Sided|95.0|0.3|1.57||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 200ug/placebo for day 7.||
1629550|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|1.07||||0.442|2-Sided|95.0|0.43|2.59||Posterior Probability the True Treatment Ratio <1 for Day 14|Bayesian repeated measures||Comparison of IL6 concentrations at Day 14. This is the baseline corrected ratio of 100ug/placebo for day 14.||
1629551|NCT02130635|2993549|Superiority or Other||Adjusted Median Ratio|0.9||||0.599|2-Sided|95.0|0.39|2.07||Posterior Probability the True Treatment Ratio <1 for Day 7|Bayesian repeated measures||Comparison of IL6 concentrations at Day 7. This is the baseline corrected ratio of 100ug/placebo for day 7.||
1629552|NCT02130583|2993574|Superiority||Mean Difference (Net)|2.06||||0.034|2-Sided||||||ANOVA||||
1629553|NCT02130570|2993576|Superiority||Odds Ratio, log|0.85||||0.57|2-Sided|95.0|0.47|1.51||"Please see the Other Statistical Analysis field for adjustments and the P-value computed for each survey question."|Regression, Logistic||"Please see the Other Statistical Analysis field for a list of the estimated value and 95% CI for each survey question."||"Please see the Other Statistical Analysis field for adjustments."
1629554|NCT02130570|2993577|Superiority||Mean Difference (Final Values)|0.08||||0.91|2-Sided|||||This is the P-value for the adjusted difference.|Regression, Linear|"Please see the Other Statistical Analysis field for adjustments."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score; clustered by inpatient unit; primary care practice as a random effect.
1629555|NCT02130570|2993578|Superiority||Odds Ratio (OR)|1.08||||0.77|2-Sided|95.0|0.64|1.85||This is the P-value for the adjusted Odds Ratio|Regression, Logistic|"For adjustments, please see the Other Statistical Analysis field below."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score; clustered by inpatient unit; primary care practice as a random effect . OR: odds ratio
1629556|NCT02130570|2993579|Superiority||Incidence rate ratio|0.78||||0.01|2-Sided|95.0|0.64|0.95||This is the p-value for the adjusted rate|Regression poissant|"For adjustments, please see the Other Statistical Analysis field below."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score, inpatient unit, and primary care practice. IRR: incidence rate ratio
1629557|NCT02130570|2993580|Superiority||Incidence rate ratio|0.52||||0.02|2-Sided|95.0|0.3|0.91||This is the P-value for the adjusted IRR.|Regression poissant|"Please see the Other Statistical Analysis field for adjustments."|||Adjusted for study month, Elixhauser comorbidity score, patient age, sex, language, race/ethnicity, cognitive status, health literacy, functional status one month prior to admission, caregiver status, median income by zip code, ED visits in the previous 6 months, HOSPITAL readmission risk score, inpatient unit, and primary care practice. IRR: incidence rate ratio
1629558|NCT02130557|2993593|Superiority||Odds Ratio (OR)|1.74||||0.0037|2-Sided|95.0|1.16|2.61||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group and region determined at time of randomization. Threshold for statistical significance: 1-sided 0.0125 significance level|Cochran-Mantel-Haenszel||95% CI for the odds ratio adjusted for sokal risk group and region are based on asymptotic wald confidence limits.|If the primary analysis was significant, each endpoint of the short-term family (CCyR by Month 12) was tested via the Bonferroni’s procedure at the 1-sided 0.0125 significance level.|
1629559|NCT02130557|2993596|Superiority||Odds Ratio (OR)|1.547||||0.01|2-Sided|95.0|1.072|2.233||1-sided p-value based on CMH test for general association between treatment and response with stratification by sokal risk group and region determined at time of randomization. Threshold for statistical significance: 1-sided 0.0125 significance level|Cochran-Mantel-Haenszel||95% CI for the odds ratio adjusted for sokal risk group and region are based on asymptotic wald confidence limits.|A total sample size of 500 Ph+ participants is required for the study to provide >= 90% power to detect at least 15% difference (assuming 25% in the imatinib vs 40% in the bosutinib arm) in the MMR rates at 12 months (48 weeks) with a 1-sided alpha of 2.5%, and 2 interim futility analyses at 33% and 66% of patients with adequate follow-up with early stopping for futility only (non-binding, O’Brien-Fleming analog beta spending function).|
1629560|NCT02130258|2993605|Other|||||||0.04|||||||Kruskal-Wallis||||
1629561|NCT02130258|2993606|Other|||||||0.04|||||||Kruskal-Wallis||||
1629562|NCT02130258|2993607|Other|||||||0.04|||||||Kruskal-Wallis||||
1629563|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.3|Standard Deviation|0.42||0.17|2-Sided|95.0|-1.12|0.54||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 12 month. Data presented are for 95% equal-tailed credible intervals||
1629564|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.1|Standard Deviation|0.41||0.07|2-Sided|95.0|-0.89|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 11 month. Data presented are for 95% equal-tailed credible intervals||
1629565|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.53|Standard Deviation|0.43||0.36|2-Sided|95.0|-1.4|0.29||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 10 month. Data presented are for 95% equal-tailed credible intervals||
1629566|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.26|Standard Deviation|0.41||0.14|2-Sided|95.0|-1.07|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 9 month. Data presented are for 95% equal-tailed credible intervals||
1629945|NCT02128490|2993787|Superiority or Other||Difference in Proportions|-17.5||||0.139|2-Sided|95.0|-38.1|3.2|||Fisher Exact||||
1629567|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.39|Standard Deviation|0.4||0.22|2-Sided|95.0|-1.12|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 8 month. Data presented are for 95% equal-tailed credible intervals||
1629568|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.08|Standard Deviation|0.36||0.04|2-Sided|95.0|-0.79|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 7 month. Data presented are for 95% equal-tailed credible intervals||
1629569|NCT02130193|2993612|Superiority or Other||Posterior mean difference|0.02|Standard Deviation|0.36||0.02|2-Sided|95.0|-0.69|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 6 month. Data presented are for 95% equal-tailed credible intervals||
1629570|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.11|Standard Deviation|0.37||0.05|2-Sided|95.0|-0.82|0.61||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 5 month. Data presented are for 95% equal-tailed credible intervals||
1629571|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.21|Standard Deviation|0.37||0.09|2-Sided|95.0|-0.92|0.5||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 4 month. Data presented are for 95% equal-tailed credible intervals||
1629572|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.2|Standard Deviation|0.38||0.09|2-Sided|95.0|-0.94|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 3 month. Data presented are for 95% equal-tailed credible intervals||
1629573|NCT02130193|2993612|Superiority or Other||Posterior mean difference|0.19|Standard Deviation|0.35||0.01|2-Sided|95.0|-0.53|0.85||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 2 month. Data presented are for 95% equal-tailed credible intervals||
1629574|NCT02130193|2993612|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.31||0.01|2-Sided|95.0|-0.59|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 1 month. Data presented are for 95% equal-tailed credible intervals||
1629575|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.3|Standard Deviation|0.42||0.77|2-Sided|95.0|-1.12|0.54||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 12 month. Data presented are for 95% equal-tailed credible intervals||
1629576|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.1|Standard Deviation|0.41||0.59|2-Sided|95.0|-0.89|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 11 month. Data presented are for 95% equal-tailed credible intervals||
1629577|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.53|Standard Deviation|0.43||0.89|2-Sided|95.0|-1.4|0.29||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 10 month. Data presented are for 95% equal-tailed credible intervals||
1629578|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.26|Standard Deviation|0.41||0.74|2-Sided|95.0|-1.07|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 9 month. Data presented are for 95% equal-tailed credible intervals||
1629579|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.39|Standard Deviation|0.4||0.83|2-Sided|95.0|-1.12|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 8 month. Data presented are for 95% equal-tailed credible intervals||
1629580|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.08|Standard Deviation|0.36||0.58|2-Sided|95.0|-0.79|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 7 month. Data presented are for 95% equal-tailed credible intervals||
1629581|NCT02130193|2993612|Superiority or Other||Posterior mean difference|0.02|Standard Deviation|0.36||0.48|2-Sided|95.0|-0.69|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 6 month. Data presented are for 95% equal-tailed credible intervals||
1629582|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.11|Standard Deviation|0.37||0.61|2-Sided|95.0|-0.82|0.61||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 5 month. Data presented are for 95% equal-tailed credible intervals||
1629583|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.21|Standard Deviation|0.37||0.71|2-Sided|95.0|-0.92|0.5||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 4 month. Data presented are for 95% equal-tailed credible intervals||
1629584|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.2|Standard Deviation|0.38||0.7|2-Sided|95.0|-0.94|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 3 month. Data presented are for 95% equal-tailed credible intervals||
1629585|NCT02130193|2993612|Superiority or Other||Posterior mean difference|0.19|Standard Deviation|0.35||0.29|2-Sided|95.0|-0.53|0.85||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 2 month. Data presented are for 95% equal-tailed credible intervals||
1629586|NCT02130193|2993612|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.31||0.43|2-Sided|95.0|-0.59|0.62||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-cough, 1 month. Data presented are for 95% equal-tailed credible intervals||
1629587|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.43|Standard Deviation|0.5||0.29|2-Sided|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals||
1629588|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.49|Standard Deviation|0.5||0.33|2-Sided|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals||
1629589|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.73|Standard Deviation|0.49||0.52|2-Sided|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals||
1629590|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.46|Standard Deviation|0.49||0.32|2-Sided|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals||
1629591|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.48|Standard Deviation|0.48||0.32|2-Sided|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals||
1629592|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.32|Standard Deviation|0.44||0.19|2-Sided|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals||
1629593|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.39|Standard Deviation|0.44||0.24|2-Sided|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals||
1629594|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.4|Standard Deviation|0.42||0.24|2-Sided|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals||
1629595|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.32|Standard Deviation|0.41||0.18|2-Sided|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals||
1629596|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.56|Standard Deviation|0.43||0.37|2-Sided|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals||
1629597|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.17|Standard Deviation|0.39||0.09|2-Sided|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals||
1629598|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.14|Standard Deviation|0.35||0.06|2-Sided|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals||
1629599|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.43|Standard Deviation|0.5||0.13|2-Sided|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals||
1629600|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.49|Standard Deviation|0.5||0.15|2-Sided|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals||
1629601|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.73|Standard Deviation|0.49||0.29|2-Sided|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals||
1629602|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.46|Standard Deviation|0.49||0.14|2-Sided|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals||
1629603|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.48|Standard Deviation|0.48||0.14|2-Sided|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals||
1629604|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.32|Standard Deviation|0.44||0.06|2-Sided|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals||
1629605|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.39|Standard Deviation|0.44||0.08|2-Sided|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals||
1629606|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.4|Standard Deviation|0.42||0.08|2-Sided|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals||
1629607|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.32|Standard Deviation|0.41||0.05|2-Sided|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals||
1629608|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.56|Standard Deviation|0.43||0.15|2-Sided|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals||
1629609|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.17|Standard Deviation|0.39||0.02|2-Sided|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals||
1629610|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.14|Standard Deviation|0.35||0.01|2-Sided|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals||
1629611|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.43|Standard Deviation|0.5||0.81|2-Sided|95.0|-1.36|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 12 month. Data presented are for 95% equal-tailed credible intervals||
1629612|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.49|Standard Deviation|0.5||0.84|2-Sided|95.0|-1.45|0.48||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 11 month. Data presented are for 95% equal-tailed credible intervals||
1629613|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.73|Standard Deviation|0.49||0.94|2-Sided|95.0|-1.68|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 10 month. Data presented are for 95% equal-tailed credible intervals||
1629614|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.46|Standard Deviation|0.49||0.83|2-Sided|95.0|-1.49|0.38||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 9 month. Data presented are for 95% equal-tailed credible intervals||
1629615|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.48|Standard Deviation|0.48||0.84|2-Sided|95.0|-1.43|0.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 8 month. Data presented are for 95% equal-tailed credible intervals||
1629616|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.32|Standard Deviation|0.44||0.76|2-Sided|95.0|-1.14|0.56||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 7 month. Data presented are for 95% equal-tailed credible intervals||
1629617|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.39|Standard Deviation|0.44||0.81|2-Sided|95.0|-1.23|0.47||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 6 month. Data presented are for 95% equal-tailed credible intervals||
1629618|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.4|Standard Deviation|0.42||0.84|2-Sided|95.0|-1.24|0.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 5 month. Data presented are for 95% equal-tailed credible intervals||
1629619|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.32|Standard Deviation|0.41||0.79|2-Sided|95.0|-1.16|0.44||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 4 month. Data presented are for 95% equal-tailed credible intervals||
1629620|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.56|Standard Deviation|0.43||0.91|2-Sided|95.0|-1.46|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 3 month. Data presented are for 95% equal-tailed credible intervals||
1629621|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.17|Standard Deviation|0.39||0.66|2-Sided|95.0|-0.94|0.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 2 month. Data presented are for 95% equal-tailed credible intervals||
1629622|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.14|Standard Deviation|0.35||0.66|2-Sided|95.0|-0.84|0.52||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-chest, 1 month. Data presented are for 95% equal-tailed credible intervals||
1629623|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.49|Standard Deviation|0.9||0.41|2-Sided|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals||
1629624|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.36|Standard Deviation|0.91||0.36|2-Sided|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals||
1629625|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.89|Standard Deviation|0.89||0.58|2-Sided|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals||
1629626|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.34|Standard Deviation|0.88||0.35|2-Sided|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals||
1629627|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.5|Standard Deviation|0.87||0.42|2-Sided|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals||
1629628|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.5|Standard Deviation|0.85||0.42|2-Sided|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals||
1629629|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.43|Standard Deviation|0.86||0.39|2-Sided|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals||
1629630|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.36|Standard Deviation|0.83||0.36|2-Sided|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals||
1629631|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.55|Standard Deviation|0.81||0.43|2-Sided|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals||
1629632|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.6|Standard Deviation|0.8||0.46|2-Sided|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals||
1629633|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.53|Standard Deviation|0.78||0.41|2-Sided|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals||
1629634|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.23|Standard Deviation|0.72||0.26|2-Sided|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals||
1629635|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.49|Standard Deviation|0.9||0.28|2-Sided|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals||
1629636|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.36|Standard Deviation|0.91||0.24|2-Sided|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals||
1629637|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.89|Standard Deviation|0.89||0.45|2-Sided|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals||
1629638|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.34|Standard Deviation|0.88||0.23|2-Sided|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals||
1629639|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.5|Standard Deviation|0.87||0.29|2-Sided|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals||
1629640|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.5|Standard Deviation|0.85||0.28|2-Sided|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals||
1629641|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.43|Standard Deviation|0.86||0.26|2-Sided|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals||
1629946|NCT02128490|2993787|Superiority or Other||Difference in Proportions|31.6||||0.004|2-Sided|95.0|13.1|50.1|||Fisher Exact||||
1629947|NCT02128490|2993787|Superiority or Other||Difference in Proportions|12.6||||0.224|2-Sided|95.0|-3.9|29.0|||Fisher Exact||||
1629642|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.36|Standard Deviation|0.83||0.23|2-Sided|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals||
1629643|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.55|Standard Deviation|0.81||0.29|2-Sided|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals||
1629644|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.6|Standard Deviation|0.8||0.31|2-Sided|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals||
1629645|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.53|Standard Deviation|0.78||0.27|2-Sided|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals||
1629646|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.23|Standard Deviation|0.72||0.13|2-Sided|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals||
1629647|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.49|Standard Deviation|0.9||0.71|2-Sided|95.0|-2.36|1.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 12 month. Data presented are for 95% equal-tailed credible intervals||
1629648|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.36|Standard Deviation|0.91||0.65|2-Sided|95.0|-2.15|1.41||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 11 month. Data presented are for 95% equal-tailed credible intervals||
1629649|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.89|Standard Deviation|0.89||0.84|2-Sided|95.0|-2.71|0.69||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 10 month. Data presented are for 95% equal-tailed credible intervals||
1629650|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.34|Standard Deviation|0.88||0.66|2-Sided|95.0|-2.14|1.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 9 month. Data presented are for 95% equal-tailed credible intervals||
1629651|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.5|Standard Deviation|0.87||0.71|2-Sided|95.0|-2.11|1.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 8 month. Data presented are for 95% equal-tailed credible intervals||
1629652|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.5|Standard Deviation|0.85||0.72|2-Sided|95.0|-2.1|1.08||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 7 month. Data presented are for 95% equal-tailed credible intervals||
1629653|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.43|Standard Deviation|0.86||0.69|2-Sided|95.0|-1.99|1.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 6 month. Data presented are for 95% equal-tailed credible intervals||
1629654|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.36|Standard Deviation|0.83||0.67|2-Sided|95.0|-1.88|1.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 5 month. Data presented are for 95% equal-tailed credible intervals||
1629655|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.55|Standard Deviation|0.81||0.74|2-Sided|95.0|-2.23|0.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 4 month. Data presented are for 95% equal-tailed credible intervals||
1629656|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.6|Standard Deviation|0.8||0.77|2-Sided|95.0|-2.09|0.98||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 3 month. Data presented are for 95% equal-tailed credible intervals||
1629657|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.53|Standard Deviation|0.78||0.75|2-Sided|95.0|-1.91|1.1||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 2 month. Data presented are for 95% equal-tailed credible intervals||
1629658|NCT02130193|2993612|Superiority or Other||Posterior mean difference|-0.23|Standard Deviation|0.72||0.64|2-Sided|95.0|-1.53|1.25||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS-breath, 1 month. Data presented are for 95% equal-tailed credible intervals||
1629659|NCT02130193|2993615|Superiority or Other||Hazard Ratio (HR)|1.32||||0.001|2-Sided|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629660|NCT02130193|2993615|Superiority or Other||Hazard Ratio (HR)|1.32||||0.012|2-Sided|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1630373|NCT02115308|2994937|Superiority|||||||0.365|||||||t-test, 2 sided|non-adjusted||REST|
1629661|NCT02130193|2993615|Superiority or Other||Hazard Ratio (HR)|1.32||||0.049|2-Sided|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629662|NCT02130193|2993615|Superiority or Other||Hazard Ratio (HR)|1.32||||0.111|2-Sided|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629663|NCT02130193|2993615|Superiority or Other||Hazard Ratio (HR)|1.32||||0.212|2-Sided|95.0|0.73|2.11||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629664|NCT02130193|2993616|Superiority or Other||Hazard Ratio (HR)|1.07||||0.052|2-Sided|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.6 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629665|NCT02130193|2993616|Superiority or Other||Hazard Ratio (HR)|1.07||||0.116|2-Sided|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.7 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629666|NCT02130193|2993616|Superiority or Other||Hazard Ratio (HR)|1.07||||0.221|2-Sided|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.8 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629667|NCT02130193|2993616|Superiority or Other||Hazard Ratio (HR)|1.07||||0.343|2-Sided|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 0.9 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629668|NCT02130193|2993616|Superiority or Other||Hazard Ratio (HR)|1.07||||0.477|2-Sided|95.0|0.55|1.82||Posterior probability that the treatment ratio (DNX 75 mg/ placebo) is less than 1.0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629669|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.73|Standard Deviation|2.7||0.32|2-Sided|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals||
1629670|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.16|Standard Deviation|2.72||0.25|2-Sided|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals||
1629671|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-3.44|Standard Deviation|2.72||0.57|2-Sided|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals||
1629672|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.92|Standard Deviation|2.63||0.35|2-Sided|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals||
1629673|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-2.1|Standard Deviation|2.63||0.36|2-Sided|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals||
1629674|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.6|Standard Deviation|2.45||0.29|2-Sided|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals||
1629675|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.31|Standard Deviation|2.42||0.24|2-Sided|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals||
1629676|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.3|Standard Deviation|2.4||0.23|2-Sided|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals||
1629677|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.64|Standard Deviation|2.31||0.28|2-Sided|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals||
1629678|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.99|Standard Deviation|2.29||0.32|2-Sided|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals||
1629679|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-0.72|Standard Deviation|2.21||0.15|2-Sided|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals||
1629680|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-0.57|Standard Deviation|2.04||0.11|2-Sided|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -3 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals||
1629681|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.73|Standard Deviation|2.7||0.45|2-Sided|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals||
1629682|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.16|Standard Deviation|2.72||0.38|2-Sided|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals||
1629683|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-3.44|Standard Deviation|2.72||0.7|2-Sided|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals||
1629684|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.92|Standard Deviation|2.63||0.5|2-Sided|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals||
1629685|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-2.1|Standard Deviation|2.63||0.51|2-Sided|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals||
1629686|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.6|Standard Deviation|2.45||0.43|2-Sided|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals||
1629687|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.31|Standard Deviation|2.42||0.38|2-Sided|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals||
1629688|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.3|Standard Deviation|2.4||0.37|2-Sided|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals||
1629689|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.64|Standard Deviation|2.31||0.43|2-Sided|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals||
1629690|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.99|Standard Deviation|2.29||0.5|2-Sided|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals||
1629691|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-0.72|Standard Deviation|2.21||0.28|2-Sided|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals||
1629692|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-0.57|Standard Deviation|2.04||0.24|2-Sided|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -2 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals||
1629693|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.73|Standard Deviation|2.7||0.6|2-Sided|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals||
1629694|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.16|Standard Deviation|2.72||0.52|2-Sided|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals||
1629695|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-3.44|Standard Deviation|2.72||0.81|2-Sided|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals||
1629696|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.92|Standard Deviation|2.63||0.63|2-Sided|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals||
1629697|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-2.1|Standard Deviation|2.63||0.65|2-Sided|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals||
1629698|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.6|Standard Deviation|2.45||0.59|2-Sided|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals||
1629699|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.31|Standard Deviation|2.42||0.55|2-Sided|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals||
1629700|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.3|Standard Deviation|2.4||0.55|2-Sided|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals||
1629701|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.64|Standard Deviation|2.31||0.62|2-Sided|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals||
1629702|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.99|Standard Deviation|2.29||0.67|2-Sided|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals||
1629703|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-0.72|Standard Deviation|2.21||0.45|2-Sided|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals||
1629704|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-0.57|Standard Deviation|2.04||0.43|2-Sided|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than -1 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals||
1629705|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.73|Standard Deviation|2.7||0.74|2-Sided|95.0|-6.91|3.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 12 month. Data presented are for 95% equal-tailed credible intervals||
1629706|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.16|Standard Deviation|2.72||0.66|2-Sided|95.0|-6.2|4.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 11 month. Data presented are for 95% equal-tailed credible intervals||
1629707|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-3.44|Standard Deviation|2.72||0.9|2-Sided|95.0|-8.74|1.87||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 10 month. Data presented are for 95% equal-tailed credible intervals||
1629708|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.92|Standard Deviation|2.63||0.77|2-Sided|95.0|-7.04|3.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 9 month. Data presented are for 95% equal-tailed credible intervals||
1629709|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-2.1|Standard Deviation|2.63||0.79|2-Sided|95.0|-6.93|3.3||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 8 month. Data presented are for 95% equal-tailed credible intervals||
1629710|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.6|Standard Deviation|2.45||0.74|2-Sided|95.0|-6.75|2.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 7 month. Data presented are for 95% equal-tailed credible intervals||
1629711|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.31|Standard Deviation|2.42||0.7|2-Sided|95.0|-6.46|3.05||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 6 month. Data presented are for 95% equal-tailed credible intervals||
1629712|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.3|Standard Deviation|2.4||0.71|2-Sided|95.0|-5.7|3.55||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 5 month. Data presented are for 95% equal-tailed credible intervals||
1629713|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.64|Standard Deviation|2.31||0.77|2-Sided|95.0|-5.92|3.07||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 4 month. Data presented are for 95% equal-tailed credible intervals||
1629714|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-1.99|Standard Deviation|2.29||0.81|2-Sided|95.0|-6.6|2.27||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 3 month. Data presented are for 95% equal-tailed credible intervals||
1629715|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-0.72|Standard Deviation|2.21||0.64|2-Sided|95.0|-5.03|3.6||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 2 month. Data presented are for 95% equal-tailed credible intervals||
1629716|NCT02130193|2993617|Superiority or Other||Posterior mean difference|-0.57|Standard Deviation|2.04||0.62|2-Sided|95.0|-4.55|3.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-PRO, 1 month. Data presented are for 95% equal-tailed credible intervals||
1629717|NCT02130193|2993618|Superiority or Other||Posterior mean difference|1.15|Standard Deviation|0.242||0.002|2-Sided|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629718|NCT02130193|2993618|Superiority or Other||Posterior mean difference|1.15|Standard Deviation|0.242||0.011|2-Sided|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629719|NCT02130193|2993618|Superiority or Other||Posterior mean difference|1.15|Standard Deviation|0.242||0.05|2-Sided|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629720|NCT02130193|2993618|Superiority or Other||Posterior mean difference|1.15|Standard Deviation|0.242||0.138|2-Sided|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629721|NCT02130193|2993618|Superiority or Other||Posterior mean difference|1.15|Standard Deviation|0.242||0.278|2-Sided|95.0|0.71|1.63||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629722|NCT02130193|2993622|Superiority or Other||Posterior mean difference|-1.35|Standard Deviation|1.74||0.78|2-Sided|95.0|-4.77|2.04||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 12 month. Data presented are for 95% equal-tailed credible intervals||
1629723|NCT02130193|2993622|Superiority or Other||Posterior mean difference|-1.05|Standard Deviation|1.73||0.71|2-Sided|95.0|-4.73|2.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 11 month. Data presented are for 95% equal-tailed credible intervals||
1629724|NCT02130193|2993622|Superiority or Other||Posterior mean difference|-2.26|Standard Deviation|1.74||0.91|2-Sided|95.0|-5.66|0.99||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 10 month. Data presented are for 95% equal-tailed credible intervals||
1629725|NCT02130193|2993622|Superiority or Other||Posterior mean difference|-1.23|Standard Deviation|1.75||0.76|2-Sided|95.0|-4.66|2.22||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 9 month. Data presented are for 95% equal-tailed credible intervals||
1629726|NCT02130193|2993622|Superiority or Other||Posterior mean difference|-1.48|Standard Deviation|1.69||0.81|2-Sided|95.0|-4.71|1.76||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 8 month. Data presented are for 95% equal-tailed credible intervals||
1629727|NCT02130193|2993622|Superiority or Other||Posterior mean difference|-1.0|Standard Deviation|1.58||0.73|2-Sided|95.0|-4.15|2.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 7 month. Data presented are for 95% equal-tailed credible intervals||
1629728|NCT02130193|2993622|Superiority or Other||Posterior mean difference|-0.93|Standard Deviation|1.58||0.72|2-Sided|95.0|-4.01|2.26||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 6 month. Data presented are for 95% equal-tailed credible intervals||
1629729|NCT02130193|2993622|Superiority or Other||Posterior mean difference|-0.96|Standard Deviation|1.56||0.73|2-Sided|95.0|-3.82|2.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 5 month. Data presented are for 95% equal-tailed credible intervals||
1629730|NCT02130193|2993622|Superiority or Other||Posterior mean difference|-1.2|Standard Deviation|1.53||0.78|2-Sided|95.0|-4.07|1.9||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 4 month. Data presented are for 95% equal-tailed credible intervals||
1629731|NCT02130193|2993622|Superiority or Other||Posterior mean difference|-1.46|Standard Deviation|1.52||0.83|2-Sided|95.0|-4.43|1.45||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 3 month. Data presented are for 95% equal-tailed credible intervals||
1629732|NCT02130193|2993622|Superiority or Other||Posterior mean difference|-0.58|Standard Deviation|1.42||0.65|2-Sided|95.0|-3.11|2.37||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 2 month. Data presented are for 95% equal-tailed credible intervals||
1629733|NCT02130193|2993622|Superiority or Other||Posterior mean difference|-0.36|Standard Deviation|1.29||0.6|2-Sided|95.0|-2.81|2.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0 is presented.|Bayesian analysis|P-value is actually a posterior probability.|EXACT-RS, 1 month. Data presented are for 95% equal-tailed credible intervals||
1629734|NCT02130193|2993623|Superiority or Other||Posterior mean difference|2.48|Standard Deviation|0.977|<|0.001|2-Sided|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.6 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629735|NCT02130193|2993623|Superiority or Other||Posterior mean difference|2.48|Standard Deviation|0.977|<|0.001|2-Sided|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.7 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629736|NCT02130193|2993623|Superiority or Other||Posterior mean difference|2.48|Standard Deviation|0.977|<|0.003|2-Sided|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.8 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629737|NCT02130193|2993623|Superiority or Other||Posterior mean difference|2.48|Standard Deviation|0.977|<|0.006|2-Sided|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 0.9 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629948|NCT02128490|2993788|Superiority or Other||Difference in Proportions|4.2||||0.817|2-Sided|95.0|-18.2|26.6|||Fisher Exact||||
1629738|NCT02130193|2993623|Superiority or Other||Posterior mean difference|2.48|Standard Deviation|0.977|<|0.013|2-Sided|95.0|0.92|4.43||Posterior probability that the treatment difference (DNX 75 mg-placebo) is less than 1.0 is presented.|Bayesian Cox analysis|P-value is actually a posterior probability.|Data presented are for 95% equal-tailed credible intervals||
1629739|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.05|Standard Deviation|0.11||0.33|2-Sided|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals||
1629740|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.05|Standard Deviation|0.11||0.4|2-Sided|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals||
1629741|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.05|Standard Deviation|0.11||0.46|2-Sided|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals||
1629742|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.05|Standard Deviation|0.11||0.55|2-Sided|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals||
1629743|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.05|Standard Deviation|0.11||0.61|2-Sided|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals||
1629744|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.05|Standard Deviation|0.11||0.68|2-Sided|95.0|-0.15|0.28||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 364. Data presented are for 95% equal-tailed credible intervals||
1629745|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.09|Standard Deviation|0.12||0.46|2-Sided|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals||
1629746|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.09|Standard Deviation|0.12||0.53|2-Sided|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals||
1629747|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.09|Standard Deviation|0.12||0.59|2-Sided|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals||
1629748|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.09|Standard Deviation|0.12||0.65|2-Sided|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals||
1629749|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.09|Standard Deviation|0.12||0.71|2-Sided|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals||
1629750|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.09|Standard Deviation|0.12||0.76|2-Sided|95.0|-0.15|0.32||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 280. Data presented are for 95% equal-tailed credible intervals||
1629751|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.05|Standard Deviation|0.09||0.3|2-Sided|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals||
1629752|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.05|Standard Deviation|0.09||0.39|2-Sided|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals||
1629753|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.05|Standard Deviation|0.09||0.48|2-Sided|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals||
1629754|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.05|Standard Deviation|0.09||0.57|2-Sided|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals||
1629755|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.05|Standard Deviation|0.09||0.65|2-Sided|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals||
1629756|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.05|Standard Deviation|0.09||0.72|2-Sided|95.0|-0.13|0.24||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 168. Data presented are for 95% equal-tailed credible intervals||
1629949|NCT02128490|2993788|Superiority or Other||Difference in Proportions|22.4||||0.034|2-Sided|95.0|3.7|41.0|||Fisher Exact||||
1629757|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.01|Standard Deviation|0.1||0.12|2-Sided|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals||
1629758|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.01|Standard Deviation|0.1||0.17|2-Sided|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals||
1629759|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.01|Standard Deviation|0.1||0.22|2-Sided|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals||
1629760|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.01|Standard Deviation|0.1||0.3|2-Sided|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals||
1629761|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.01|Standard Deviation|0.1||0.37|2-Sided|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals||
1629762|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.01|Standard Deviation|0.1||0.45|2-Sided|95.0|-0.2|0.17||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 112. Data presented are for 95% equal-tailed credible intervals||
1629763|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.02|Standard Deviation|0.09||0.07|2-Sided|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals||
1629764|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.02|Standard Deviation|0.09||0.12|2-Sided|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals||
1629765|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.02|Standard Deviation|0.09||0.18|2-Sided|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals||
1629766|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.02|Standard Deviation|0.09||0.25|2-Sided|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals||
1629767|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.02|Standard Deviation|0.09||0.32|2-Sided|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals||
1629768|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.02|Standard Deviation|0.09||0.41|2-Sided|95.0|-0.2|0.15||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 56. Data presented are for 95% equal-tailed credible intervals||
1629769|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.02|Standard Deviation|0.08||0.07|2-Sided|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals||
1629770|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.02|Standard Deviation|0.08||0.11|2-Sided|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals||
1629771|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.02|Standard Deviation|0.08||0.16|2-Sided|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals||
1629772|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.02|Standard Deviation|0.08||0.24|2-Sided|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals||
1629773|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.02|Standard Deviation|0.08||0.32|2-Sided|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals||
1629774|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.02|Standard Deviation|0.08||0.41|2-Sided|95.0|-0.19|0.13||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FVC, Day 28. Data presented are for 95% equal-tailed credible intervals||
1629775|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.04|Standard Deviation|0.08||0.22|2-Sided|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals||
1630374|NCT02115308|2994937|Superiority|||||||0.495||||||non-adjusted|paired, t-test|||REST-TO-REGADENOSON STRESS|
1629776|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.04|Standard Deviation|0.08||0.3|2-Sided|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals||
1629777|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.04|Standard Deviation|0.08||0.4|2-Sided|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals||
1629778|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.04|Standard Deviation|0.08||0.5|2-Sided|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals||
1629779|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.04|Standard Deviation|0.08||0.59|2-Sided|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals||
1629780|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.04|Standard Deviation|0.08||0.68|2-Sided|95.0|-0.14|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 364. Data presented are for 95% equal-tailed credible intervals||
1629781|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.08||0.3|2-Sided|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals||
1629782|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.08||0.39|2-Sided|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals||
1629783|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.08||0.5|2-Sided|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals||
1629784|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.08||0.59|2-Sided|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals||
1629785|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.08||0.69|2-Sided|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals||
1629786|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.08||0.78|2-Sided|95.0|-0.11|0.2||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 280. Data presented are for 95% equal-tailed credible intervals||
1629787|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.0|Standard Deviation|0.07||0.09|2-Sided|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals||
1629788|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.0|Standard Deviation|0.07||0.13|2-Sided|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals||
1629789|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.0|Standard Deviation|0.07||0.19|2-Sided|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals||
1629790|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.0|Standard Deviation|0.07||0.26|2-Sided|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals||
1629791|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.0|Standard Deviation|0.07||0.36|2-Sided|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals||
1629792|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.0|Standard Deviation|0.07||0.47|2-Sided|95.0|-0.16|0.14||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 168. Data presented are for 95% equal-tailed credible intervals||
1629793|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.08|Standard Deviation|0.08||0.41|2-Sided|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals||
1629794|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.08|Standard Deviation|0.08||0.51|2-Sided|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals||
1629950|NCT02128490|2993788|Superiority or Other||Difference in Proportions|44.7|||<|0.001|2-Sided|95.0|28.9|60.5|||Fisher Exact||||
1629795|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.08|Standard Deviation|0.08||0.61|2-Sided|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals||
1629796|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.08|Standard Deviation|0.08||0.71|2-Sided|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals||
1629797|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.08|Standard Deviation|0.08||0.79|2-Sided|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals||
1629798|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.08|Standard Deviation|0.08||0.85|2-Sided|95.0|-0.06|0.23||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 112. Data presented are for 95% equal-tailed credible intervals||
1629799|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.04|Standard Deviation|0.07||0.03|2-Sided|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals||
1629800|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.04|Standard Deviation|0.07||0.05|2-Sided|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals||
1629801|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.04|Standard Deviation|0.07||0.09|2-Sided|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals||
1629802|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.04|Standard Deviation|0.07||0.14|2-Sided|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals||
1629803|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.04|Standard Deviation|0.07||0.22|2-Sided|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals||
1629804|NCT02130193|2993627|Superiority or Other||Posterior mean difference|-0.04|Standard Deviation|0.07||0.31|2-Sided|95.0|-0.2|0.09||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 56. Data presented are for 95% equal-tailed credible intervals||
1629805|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.06||0.26|2-Sided|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.10 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals||
1629806|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.06||0.39|2-Sided|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.08 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals||
1629807|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.06||0.52|2-Sided|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.06 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals||
1629808|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.06||0.67|2-Sided|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.04 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals||
1629809|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.06||0.78|2-Sided|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0.02 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals||
1629810|NCT02130193|2993627|Superiority or Other||Posterior mean difference|0.06|Standard Deviation|0.06||0.87|2-Sided|95.0|-0.05|0.18||Posterior probability that the treatment difference (DNX 75 mg-placebo) is greater than 0 L is presented.|Bayesian analysis|P-value is actually a posterior probability.|FEV1, Day 28. Data presented are for 95% equal-tailed credible intervals||
1629811|NCT02130024|2993652|Other||Treatment Effect|28.88|||<|0.001|2-Sided|95.0|23.08|34.68|||Mixed Models Analysis|Fixed: BL Plasma VEGF, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from BL in Plasma VEGF|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Week 9 Analysis|
1629812|NCT02130024|2993652|Other||Treatment Effect|27.2|||<|0.001|2-Sided|95.0|21.44|32.95|||Mixed Models Analysis|Fixed: BL Plasma VEGF, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from BL in Plasma VEGF|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Week 5 Analysis|
1629813|NCT02130024|2993654|Other||Odds Ratio (OR)|0.94||||0.913|2-Sided|95.0|0.3|2.9|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥ -15 letters between the two treatment groups at study visit|Baseline to Month 24 Analysis|
1629951|NCT02128490|2993788|Superiority or Other||Difference in Proportions|35.9|||<|0.001|2-Sided|95.0|20.8|51.0|||Fisher Exact||||
1630379|NCT02114892|2994962|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1629814|NCT02130024|2993654|Other||Odds Ratio (OR)|1.63||||0.46|2-Sided|95.0|0.45|5.93|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥ -15 letters between the two treatment groups at study visit|Baseline to Month 12 Analysis|
1629815|NCT02130024|2993655|Other||Odds Ratio (OR)|1.61||||0.206|2-Sided|95.0|0.77|3.35|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥15 letters between the two treatment groups at study visit|Baseline to Month 24 Analysis|
1629816|NCT02130024|2993655|Other||Odds Ratio (OR)|1.05||||0.891|2-Sided|95.0|0.53|2.08|||Regression, Logistic|Includes treatment as factor and baseline BCVA as covariate. Model: log(p/1-p) =Treatment|Odds ratio of BCVA change from baseline ≥15 letters between the two treatment groups at study visit|Baseline to Month 12 Analysis|
1629817|NCT02130024|2993656|Other||Odds Ratio (OR)|0.87||||0.616|2-Sided|95.0|0.51|1.48|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 24 Analysis|
1629818|NCT02130024|2993656|Other||Odds Ratio (OR)|0.72||||0.215|2-Sided|95.0|0.44|1.21|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 12 Analysis|
1629819|NCT02130024|2993656|Other||Odds Ratio (OR)|0.83||||0.461|2-Sided|95.0|0.51|1.35|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of no IRF/SRF present between the two treatment groups at study visit|Month 2 Analysis|
1629820|NCT02130024|2993657|Other||Treatment Effect|11.86||||0.225|2-Sided|95.0|-7.35|31.07|||Mixed Models Analysis|Fixed effects: Baseline CSFT, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in CSFT|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 24 Analysis|
1629821|NCT02130024|2993657|Other||Treatment Effect|10.12||||0.294|2-Sided|95.0|-8.82|29.06|||Mixed Models Analysis|Fixed effects: Baseline CSFT, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in CSFT|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 12 Analysis|
1629822|NCT02130024|2993658|Other||Treatment Effect|1.95||||0.151|2-Sided|95.0|-0.71|4.61|||Mixed Models Analysis|Fixed effects: Baseline BCVA, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in BCVA|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 24 Analysis|
1629823|NCT02130024|2993658|Other||Treatment Effect|2.32||||0.079|2-Sided|95.0|-0.27|4.92|||Mixed Models Analysis|Fixed effects: Baseline BCVA, treatment, visit, and treatment by visit. Random effect: Subject. Response variable: Change from baseline in BCVA|Treatment Effect: Ranibizumab minus Aflibercept|Baseline to Month 12 Analysis|
1629824|NCT02130024|2993659|Other||Treatment Effect|1.01||||0.745|2-Sided|95.0|0.95|1.08|||Negative Binomial Regression Model|Log (number of injections) = treatment + log (year of follow-up) (offset)|Treatment effect: Injection frequency (rate) ratio of Ranibizumab vs. Aflibercept|Baseline to Month 24 Analysis|
1629825|NCT02130024|2993659|Other||Treatment Effect|0.99||||0.733|2-Sided|95.0|0.95|1.04|||Negative Binomial Regression Model|Log (number of injections) = treatment + log (year of follow-up) (offset)|Treatment effect: Injection frequency (rate) ratio of Ranibizumab vs. Aflibercept|Baseline to <Month 12 Analysis|
1629826|NCT02130024|2993660|Other||Odds Ratio (OR)|1.19||||0.554|2-Sided|95.0|0.67|2.09|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment||Baseline to Month 24 Analysis|
1629827|NCT02130024|2993660|Other||Odds Ratio (OR)|2.27||||0.11|2-Sided|95.0|0.83|6.22|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of 'Newly Developed GA (Yes)' at between the two treatment groups at study visit|Month 12 to Month 24 Analysis|
1629828|NCT02130024|2993660|Other||Odds Ratio (OR)|0.84||||0.586|2-Sided|95.0|0.44|1.59|||Regression, Logistic|Includes treatment as factor. Model: log(p/1-p) =Treatment|Odds ratio of 'Newly Developed GA (Yes)' at between the two treatment groups at study visit|Baseline to Month 12 Analysis|
1629829|NCT02130024|2993661|Other||Treatment Effect|0.02||||0.769|2-Sided|95.0|-0.11|0.15|||Mixed Models Analysis|Fixed effects: Baseline GA area, treatment, visit, treatment by visit. Random effect: Subject|||
1629830|NCT02130024|2993662|Other||Treatment Effect|0.08||||0.236|2-Sided|95.0|-0.05|0.21|||Mixed Models Analysis|Fixed effects: Baseline GA area, treatment, visit, treatment by visit. Random effect: Subject|||
1629831|NCT02129777|2993663|Superiority or Other||LS Mean Difference|2.6|Standard Error of the Mean|1.64||0.121|2-Sided|95.0|-0.7|5.8|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629832|NCT02129777|2993663|Superiority or Other||LS Mean Difference|4.0|Standard Error of the Mean|1.63||0.015|2-Sided|95.0|0.8|7.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629833|NCT02129777|2993663|Superiority or Other||LS Mean Difference|2.4|Standard Error of the Mean|1.62||0.142|2-Sided|95.0|-0.8|5.6|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629888|NCT02129777|2993677|Superiority or Other||Risk Difference (RD)|-0.027||||0.827|2-Sided|95.0|-0.265|0.211|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.|
1629834|NCT02129777|2993663|Superiority or Other||LS Mean Difference|1.0|Standard Error of the Mean|1.64||0.537|2-Sided|95.0|-2.2|4.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site,treatment,visit and interaction between visit and treatment as fixed effects,baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629835|NCT02129777|2993664|Superiority or Other||LS Mean Difference|-2.4|Standard Error of the Mean|5.1||0.633|2-Sided|95.0|-12.6|7.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629836|NCT02129777|2993664|Superiority or Other||LS Mean Difference|-1.9|Standard Error of the Mean|4.89||0.697|2-Sided|95.0|-11.7|7.8|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629837|NCT02129777|2993664|Superiority or Other||LS Mean Difference|4.8|Standard Error of the Mean|4.8||0.323|2-Sided|95.0|-4.8|14.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629838|NCT02129777|2993664|Superiority or Other||LS Mean Difference|-1.0|Standard Error of the Mean|5.32||0.845|2-Sided|95.0|-11.7|9.6|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629839|NCT02129777|2993665|Superiority or Other||LS Mean Difference|0.03|Standard Error of the Mean|0.044||0.509|2-Sided|95.0|-0.06|0.12|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629840|NCT02129777|2993665|Superiority or Other||LS Mean Difference|0.02|Standard Error of the Mean|0.043||0.597|2-Sided|95.0|-0.06|0.11|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629841|NCT02129777|2993665|Superiority or Other||LS Mean Difference|-0.02|Standard Error of the Mean|0.042||0.619|2-Sided|95.0|-0.1|0.06|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629842|NCT02129777|2993665|Superiority or Other||LS Mean Difference|-0.02|Standard Error of the Mean|0.043||0.57|2-Sided|95.0|-0.11|0.06|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629843|NCT02129777|2993666|Superiority or Other||LS Mean Difference|0.7|Standard Error of the Mean|2.4||0.767|2-Sided|95.0|-4.1|5.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629844|NCT02129777|2993666|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|2.31||0.798|2-Sided|95.0|-4.0|5.2|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629845|NCT02129777|2993666|Superiority or Other||LS Mean Difference|0.7|Standard Error of the Mean|2.24||0.77|2-Sided|95.0|-3.8|5.1|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629846|NCT02129777|2993666|Superiority or Other||LS Mean Difference|1.9|Standard Error of the Mean|2.32||0.416|2-Sided|95.0|-2.7|6.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Mental Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629847|NCT02129777|2993666|Superiority or Other||LS Mean Difference|0.9|Standard Error of the Mean|1.74||0.597|2-Sided|95.0|-2.5|4.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629848|NCT02129777|2993666|Superiority or Other||LS Mean Difference|1.4|Standard Error of the Mean|1.67||0.403|2-Sided|95.0|-1.9|4.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629849|NCT02129777|2993666|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|1.65||0.863|2-Sided|95.0|-3.6|3.0|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629850|NCT02129777|2993666|Superiority or Other||LS Mean Difference|-2.1|Standard Error of the Mean|1.73||0.229|2-Sided|95.0|-5.6|1.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Physical Health Summary Score: Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629851|NCT02129777|2993667|Superiority or Other||LS Mean Difference|-2.1|Standard Error of the Mean|1.41||0.142|2-Sided|95.0|-4.9|0.7|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629852|NCT02129777|2993667|Superiority or Other||LS Mean Difference|-1.4|Standard Error of the Mean|1.39||0.316|2-Sided|95.0|-4.2|1.4|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629853|NCT02129777|2993667|Superiority or Other||LS Mean Difference|-1.2|Standard Error of the Mean|1.36||0.389|2-Sided|95.0|-3.9|1.5|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an ANCOVA model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629854|NCT02129777|2993667|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|1.37||0.978|2-Sided|95.0|-2.7|2.8|||ANCOVA||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Post-baseline least squares means and p-values were from an Analysis of covariance (ANCOVA) model with main effect of study site and treatment with baseline value as a covariate. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629855|NCT02129777|2993668|Superiority or Other||LS Mean Difference|4.3|Standard Error of the Mean|6.74||0.523|2-Sided|95.0|-9.2|17.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629856|NCT02129777|2993668|Superiority or Other||LS Mean Difference|0.7|Standard Error of the Mean|6.67||0.914|2-Sided|95.0|-12.7|14.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629857|NCT02129777|2993668|Superiority or Other||LS Mean Difference|7.9|Standard Error of the Mean|6.73||0.248|2-Sided|95.0|-5.7|21.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629858|NCT02129777|2993668|Superiority or Other||LS Mean Difference|-1.7|Standard Error of the Mean|6.7||0.803|2-Sided|95.0|-15.2|11.8|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629859|NCT02129777|2993669|Superiority or Other||LS Mean Difference|-0.08|Standard Error of the Mean|0.496||0.873|2-Sided|95.0|-1.06|0.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629860|NCT02129777|2993669|Superiority or Other||LS Mean Difference|-0.27|Standard Error of the Mean|0.494||0.58|2-Sided|95.0|-1.26|0.71|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629861|NCT02129777|2993669|Superiority or Other||LS Mean Difference|-0.86|Standard Error of the Mean|0.497||0.087|2-Sided|95.0|-1.85|0.13|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629862|NCT02129777|2993669|Superiority or Other||LS Mean Difference|-0.63|Standard Error of the Mean|0.503||0.211|2-Sided|95.0|-1.63|0.36|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629863|NCT02129777|2993670|Superiority or Other||LS Mean Difference|-1.22|Standard Error of the Mean|0.616||0.05|2-Sided|95.0|-2.44|0.0|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629864|NCT02129777|2993670|Superiority or Other||LS Mean Difference|-0.98|Standard Error of the Mean|0.62||0.118|2-Sided|95.0|-2.21|0.25|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629865|NCT02129777|2993670|Superiority or Other||LS Mean Difference|-1.26|Standard Error of the Mean|0.619||0.045|2-Sided|95.0|-2.49|-0.03|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629866|NCT02129777|2993670|Superiority or Other||LS Mean Difference|-1.04|Standard Error of the Mean|0.626||0.099|2-Sided|95.0|-2.29|-0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629867|NCT02129777|2993671|Superiority or Other||LS Mean Difference|-1.15|Standard Error of the Mean|0.697||0.102|2-Sided|95.0|-2.54|0.23|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629868|NCT02129777|2993671|Superiority or Other||LS Mean Difference|-0.59|Standard Error of the Mean|0.69||0.396|2-Sided|95.0|-1.96|0.78|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629869|NCT02129777|2993671|Superiority or Other||LS Mean Difference|-1.15|Standard Error of the Mean|0.692||0.099|2-Sided|95.0|-2.53|0.22|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629870|NCT02129777|2993671|Superiority or Other||LS Mean Difference|-0.53|Standard Error of the Mean|0.7||0.448|2-Sided|95.0|-1.92|0.86|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629871|NCT02129777|2993672|Superiority or Other||LS Mean Difference|2.78|Standard Error of the Mean|2.173||0.203|2-Sided|95.0|-1.52|7.09|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629872|NCT02129777|2993672|Superiority or Other||LS Mean Difference|3.65|Standard Error of the Mean|2.161||0.094|2-Sided|95.0|-0.63|7.93|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629938|NCT02128763|2993762|Superiority|||||||0.09|||||||Regression, Linear||||
1629873|NCT02129777|2993672|Superiority or Other||LS Mean Difference|1.59|Standard Error of the Mean|2.143||0.459|2-Sided|95.0|-2.65|5.84|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629874|NCT02129777|2993672|Superiority or Other||LS Mean Difference|-0.19|Standard Error of the Mean|2.163||0.931|2-Sided|95.0|-4.48|4.1|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629875|NCT02129777|2993673|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.18||0.825|2-Sided|95.0|-0.4|0.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629876|NCT02129777|2993673|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.18||0.757|2-Sided|95.0|-0.3|0.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629877|NCT02129777|2993673|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.18||0.365|2-Sided|95.0|-0.5|0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an ANOVA model with terms for treatment and study site.|
1629878|NCT02129777|2993673|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.18||0.258|2-Sided|95.0|-0.6|0.2|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure. Baseline least squares means and p-values were obtained using an analysis of variance (ANOVA) model with terms for treatment and study site.|
1629879|NCT02129777|2993674|Superiority or Other||Risk Difference (RD)|0.095||||0.134|2-Sided|95.0|-0.03|0.221|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit.|
1629880|NCT02129777|2993675|Superiority or Other||Risk Difference (RD)|-0.08||||0.371|2-Sided|95.0|-0.248|0.087|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit.|
1629881|NCT02129777|2993675|Superiority or Other||Risk Difference (RD)|-0.13||||0.107|2-Sided|95.0|-0.268|0.007|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit.|
1629882|NCT02129777|2993675|Superiority or Other||Risk Difference (RD)|-0.04||||0.677|2-Sided|95.0|-0.222|0.143|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit.|
1629883|NCT02129777|2993675|Superiority or Other||Risk Difference (RD)|0.012||||0.906|2-Sided|95.0|-0.191|0.216|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and sPGA response category controlling for visit.|
1629884|NCT02129777|2993676|Superiority or Other||Risk Difference (RD)|0.048||||0.295|2-Sided|95.0|-0.043|0.139|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12:CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.|
1629885|NCT02129777|2993677|Superiority or Other||Risk Difference (RD)|-0.017||||0.89|2-Sided|95.0|-0.261|0.226|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.|
1629886|NCT02129777|2993677|Superiority or Other||Risk Difference (RD)|-0.112||||0.338|2-Sided|95.0|-0.33|0.106|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.|
1629887|NCT02129777|2993677|Superiority or Other||Risk Difference (RD)|-0.036||||0.768|2-Sided|95.0|-0.269|0.198|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.|
1629939|NCT02128763|2993763|Superiority|||||||0.4||||||P value refers to difference between group on change in overall OSDI score (Row 1).|Regression, Linear||||
1629940|NCT02128490|2993786|Superiority or Other||Difference in Proportions|-4.2||||0.817|2-Sided|95.0|-26.6|18.2|||Fisher Exact||||
1629889|NCT02129777|2993678|Superiority or Other||LS Mean Difference|2.8|Standard Error of the Mean|1.76||0.11|2-Sided|95.0|-0.7|6.3|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.|
1629890|NCT02129777|2993678|Superiority or Other||LS Mean Difference|3.0|Standard Error of the Mean|1.74||0.085|2-Sided|95.0|-0.4|6.5|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.|
1629891|NCT02129777|2993678|Superiority or Other||LS Mean Difference|1.9|Standard Error of the Mean|1.74||0.279|2-Sided|95.0|-1.6|5.4|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.|
1629892|NCT02129777|2993678|Superiority or Other||LS Mean Difference|1.4|Standard Error of the Mean|1.75||0.435|2-Sided|95.0|-2.1|4.9|||MMRM||LS mean difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Week 12: Post-baseline least squares means and p-values were from a MMRM model with main effect of study site, treatment, visit and interaction between visit and treatment as fixed effects, baseline value as a covariate with an unstructured covariance structure.|
1629893|NCT02129777|2993680|Superiority or Other||Risk Difference (RD)|-0.087||||0.182|2-Sided|95.0|-0.202|0.028|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.|
1629894|NCT02129777|2993680|Superiority or Other||Risk Difference (RD)|-0.034||||0.671|2-Sided|95.0|-0.187|0.118|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.|
1629895|NCT02129777|2993680|Superiority or Other||Risk Difference (RD)|-0.087||||0.162|2-Sided|95.0|-0.202|0.028|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|CMH P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.|
1629896|NCT02129777|2993680|Superiority or Other||Risk Difference (RD)|0.008||||0.925|2-Sided|95.0|-0.162|0.179|||Cochran-Mantel-Haenszel||Risk difference (namilumab - placebo) and corresponding 95% confidence interval were reported.|Cochran-Mantel-Haenszel (CMH) P-values are from a CMH Chi-Square test using a 2*2 contingency table of treatment and responder status controlling for visit.|
1629897|NCT02129608|2993689|Superiority or Other|||||||0.95|||||||t-test, 2 sided||||
1629898|NCT02129608|2993689|Superiority or Other|||||||0.07|||||||t-test, 2 sided||||
1629899|NCT02129608|2993690|Superiority or Other|||||||0.436|||||||t-test, 2 sided||||
1629900|NCT02129608|2993690|Superiority or Other|||||||0.398|||||||t-test, 2 sided||||
1629901|NCT02129192|2993716|Superiority or Other||Adjusted geometric mean ratio (%)|89.82|||<|0.0001|2-Sided|90.0|86.02|93.79|||ANOVA|Model included “subject” as random effect and “feeding condition” as fixed effect.|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by−treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.|
1629902|NCT02129192|2993716|Superiority or Other||Adjusted geometric mean ratio (%)|99.45|||<|0.0001|2-Sided|90.0|96.69|102.29|||ANOVA|Model included “subject” as random effect and “feeding condition” as fixed effect.|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by−treatment geometric means for amlodipine 5 mg. No hypothesis was tested.|
1629903|NCT02129192|2993716|Superiority or Other||Adjusted geometric mean ratio (%)|64.4|||<|1|2-Sided|90.0|59.59|69.59|||ANOVA|Model included “subject” as random effect and “feeding condition” as fixed effect.|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by−treatment geometric means for telmisartan 80 mg. No hypothesis was tested.|
1629904|NCT02129192|2993717|Non-Inferiority or Equivalence|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|100.15|||||2-Sided|90.0|98.23|102.1|||||Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by−treatment means on the log−transformed scale for hydrochlorothiazide 12.5 mg|
1629905|NCT02129192|2993717|Non-Inferiority or Equivalence|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|101.21|||||2-Sided|90.0|99.59|102.87|||||Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by−treatment means on the log−transformed scale for amlodipine 5 mg|
1629906|NCT02129192|2993717|Non-Inferiority or Equivalence|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-inf of the two treatments was within the pre-specified acceptance range (80%-125%).|Adjusted geometric mean ratio (%)|99.62|||||2-Sided|90.0|96.32|103.04|||||Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by−treatment means on the log−transformed scale for telmisartan 80 mg|
1629907|NCT02129192|2993718|Superiority or Other||Adjusted geometric mean ratio (%)|89.66||||0.0001|2-Sided|90.0|85.8|93.7|||ANOVA|Model included “subject” as random effect and “feeding condition” as fixed effect.|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by−treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.|
1629908|NCT02129192|2993718|Superiority or Other||Adjusted geometric mean ratio (%)|99.74|||<|0.0001|2-Sided|90.0|97.08|102.48|||ANOVA|Model included “subject” as random effect and “feeding condition” as fixed effect.|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by−treatment geometric means for amlodipine 5 mg. No hypothesis was tested.|
1629909|NCT02129192|2993718|Superiority or Other||Adjusted geometric mean ratio (%)|63.66|||<|1|2-Sided|90.0|58.98|68.71|||ANOVA|Model included “subject” as random effect and “feeding condition” as fixed effect.|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by−treatment geometric means for telmisartan 80 mg. No hypothesis was tested.|
1629910|NCT02129192|2993719|Non-Inferiority or Equivalence|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|100.33|||||2-Sided|90.0|98.29|102.4|||||Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by−treatment means on the log−transformed scale for hydrochlorothiazide 12.5 mg|
1629911|NCT02129192|2993719|Non-Inferiority or Equivalence|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.43||||||90.0|99.84|103.04|||||Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by−treatment means on the log−transformed scale for amlodipine 5 mg|
1629912|NCT02129192|2993719|Non-Inferiority or Equivalence|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of AUC 0-tz of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|99.21|||||2-Sided|90.0|96.14|102.38|||||Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by−treatment means on the log−transformed scale for telmisartan 80 mg|
1629913|NCT02129192|2993720|Superiority or Other||Adjusted geometric mean ratio (%)|79.69||||0.5422|2-Sided|90.0|74.97|84.71|||ANOVA|Model included “subject” as random effect and “feeding condition” as fixed effect.|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by−treatment geometric means for hydrochlorothiazide 12.5 mg. No hypothesis was tested.|
1629914|NCT02129192|2993720|Superiority or Other||Adjusted geometric mean ratio (%)|98.23|||<|0.0001|2-Sided|90.0|94.63|101.97|||ANOVA|Model included “subject” as random effect and “feeding condition” as fixed effect.|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by−treatment geometric means for amlodipine 5 mg. No hypothesis was tested.|
1629915|NCT02129192|2993720|Superiority or Other||Adjusted geometric mean ratio (%)|30.15|||<|1|2-Sided|90.0|24.99|36.38|||ANOVA|Model included “subject” as random effect and “feeding condition” as fixed effect.|Ratio calculated as T80/A5/H12.5 mg FDC Fed divided by T80/A5/H12.5 mg FDC Fasted.|Adjusted by−treatment geometric means for telmisartan 80 mg. No hypothesis was tested.|
1629916|NCT02129192|2993721|Non-Inferiority or Equivalence|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.77|||||2-Sided|90.0|98.46|105.19|||||Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by−treatment means on the log−transformed scale for hydrochlorothiazide 12.5 mg|
1629917|NCT02129192|2993721|Non-Inferiority or Equivalence|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|101.4|||||2-Sided|90.0|99.7|103.13|||||Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by−treatment means on the log−transformed scale for amlodipine 5 mg|
1629918|NCT02129192|2993721|Non-Inferiority or Equivalence|Bioequivalence was established by using the average bioequivalence method and by ensuring that the ratio of Cmax of the two treatments was within the pre-specified acceptance range (80%-125%)|Adjusted geometric mean ratio (%)|95.77|||||2-Sided|90.0|88.89|103.17|||||Ratio calculated as T80/A5/H12.5 mg FDC divided by T80/H12.5 FDC + A5 mono.|Adjusted by−treatment means on the log−transformed scale for telmisartan 80 mg|
1629919|NCT02128932|2993735|Non-Inferiority or Equivalence|Non-inferiority was concluded if the upper limit of the two-sided 95 % confidence interval for the estimated treatment difference between semaglutide 0.5 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3%).|Treatment difference|-0.38|||<|0.0001|2-Sided|95.0|-0.52|-0.24|||Mixed Models Analysis|||The post baseline responses were analysed using a mixed model for repeated meausrements with treatment, country and stratum value as covariate, all nested within visit.|
1629920|NCT02128932|2993735|Non-Inferiority or Equivalence|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and insulin glargine was below the pre-specified non-inferiority margin (0.3 %).|Treatment difference|-0.81|||<|0.0001|2-Sided|95.0|-0.96|-0.67|||Mixed Models Analysis|||The post baseline responses were analysed using a mixed model for repeated measurements with treatment , country and stratum as fixed factors and baseline value as covariate, all nested within visit.|
1629921|NCT02128763|2993745|Superiority|||||||0.02|||||||Regression, Linear||||
1629922|NCT02128763|2993746|Superiority|||||||0.66|||||||Regression, Linear||||
1629923|NCT02128763|2993747|Superiority|||||||0.71|||||||Regression, Linear||||
1629924|NCT02128763|2993748|Superiority|||||||0.02|||||||Regression, Linear||||
1629925|NCT02128763|2993749|Superiority|||||||0.17|||||||Regression, Linear||||
1629926|NCT02128763|2993750|Superiority|||||||0.6|||||||Chi-squared, Corrected||||
1629927|NCT02128763|2993751|Superiority|||||||0.42|||||||Regression, Linear||||
1629928|NCT02128763|2993752|Superiority|||||||0.61|||||||Regression, Linear||||
1629929|NCT02128763|2993753|Superiority|||||||0.25|||||||Regression, Linear||||
1629930|NCT02128763|2993754|Superiority|||||||0.95|||||||Regression, Linear||||
1629931|NCT02128763|2993755|Superiority|||||||0.77|||||||Regression, Linear||||
1629932|NCT02128763|2993756|Superiority|||||||0.4|||||||Regression, Linear||||
1629933|NCT02128763|2993757|Superiority||||||<|0.001|||||||Regression, Linear||||
1629934|NCT02128763|2993758|Superiority||||||<|0.001|||||||Regression, Linear||||
1629935|NCT02128763|2993759|Superiority|||||||0.051|||||||Regression, Linear||||
1629936|NCT02128763|2993760|Superiority|||||||0.95|||||||Regression, Linear||||
1629937|NCT02128763|2993761|Superiority|||||||0.77|||||||Regression, Linear|Pos hoc application of the Benjamini-Hochberg adjustment|||
1629952|NCT02127970|2993818|Non-Inferiority|The non-inferiority hypothesis test was to be a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in responder rates is greater than -10%, then the single-dose dalbavancin regimen was to be declared non-inferior to the two dose dalbavancin regimen.|Difference|-2.9|||||2-Sided|95.0|-8.5|2.8|||||For the difference in clinical responder rates (single-dose group minus two dose group), the 95% CI was calculated using the Miettinen and Nurminen method without adjustment.||
1629953|NCT02127931|2993819|Other|||||||0.013|||||||Correlation||||
1629954|NCT02127931|2993820|Other|||||||0.023|||||||Correlation|||ADHD-C|
1629955|NCT02127931|2993820|Other|||||||0.005|||||||Correlation|||ADHD-I|
1629956|NCT02127567|2993848|Superiority or Other||Mean Difference (Final Values)|1.4||||0.002|2-Sided|95.0|0.5|2.3|||Hierarchical model||||
1629957|NCT02127567|2993849|Superiority or Other||Mean Difference (Final Values)|5.4||||0.78|2-Sided|95.0|4.1|6.7|||t-test, 2 sided||||
1629958|NCT02127567|2993851|Superiority or Other||Median Difference (Final Values)|1.8|||<|0.01|2-Sided|95.0|0.7|2.9|||t-test, 2 sided||||
1629959|NCT02127567|2993852|Superiority or Other||Mean Difference (Final Values)|2.2|||<|0.01|2-Sided|95.0|0.8|3.6|||t-test, 2 sided||||
1629960|NCT02127567|2993853|Superiority or Other||Mean Difference (Final Values)|0.7||||0.44|2-Sided|95.0|-0.7|2.0|||t-test, 2 sided||||
1629961|NCT02127567|2993854|Superiority or Other||Mean Difference (Final Values)|3.8|||<|0.01|2-Sided|95.0|1.1|4.4|||t-test, 2 sided||||
1629962|NCT02127567|2993855|Superiority or Other||Mean Difference (Final Values)|2.1|||<|0.001|2-Sided|95.0|1.5|2.7|||Hierarchical model||||
1629963|NCT02127307|2993861|Superiority or Other||Hazard Ratio (HR)|0.446|||<|0.0001|2-Sided|95.0|0.3227|0.6156||At 0.025 level of significance.|Cox proportional hazards model|||"AdreView-Heart Failure Group with H/M <1.60 vs. H/M ≥1.60:~Data analysis was performed using Cox proportional hazards model to demonstrate the relationship of consensus numeric H/M ratio and time to adverse cardiac events to identify participants with higher risk of death. Hazard (risk) of a death for a participant with H/M ratio at time “t” was expressed as Hl (t)/Hh (t)=Ψ,where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively."|
1629964|NCT02126839|2993878|Superiority or Other||Mean Difference (Final Values)|76.33|Standard Error of the Mean|14.47|<|0.0001|2-Sided|95.0|47.76|104.91|||mixed model repeated measures|Fixed effects of treatment group, treatment day, and study day by treatment interaction, with baseline measured at each study day as a covariate.|||
1629965|NCT02126839|2993879|Superiority or Other||Mean Difference (Final Values)|25.02|Standard Error of the Mean|4.52|<|0.0001|2-Sided|95.0|16.1|33.94|||mixed model repeated measures analysis|Fixed effects of treatment group, treatment day, and study day by treatment interaction, with baseline measured at each study day as a covariate.|||
1629966|NCT02126826|2993880|Superiority or Other||Slope|1.081|||||2-Sided|90.0|0.8583|1.3037||||||Investigation of dose proportionality - dose groups 50mg to 200mg|
1629967|NCT02126826|2993880|Superiority or Other||Slope|0.9433|||||2-Sided|90.0|0.7744|1.1122||||||Investigation of dose proportionality - dose groups 50mg to 300mg|
1629968|NCT02126826|2993882|Superiority or Other||Slope|1.0365|||||2-Sided|90.0|0.8593|1.2137||||||Investigation of dose proportionality - dose groups 50mg to 200mg|
1629969|NCT02126826|2993882|Superiority or Other||Slope|0.7832|||||2-Sided|90.0|0.6235|0.9428||||||Investigation of dose proportionality - dose groups 50mg to 300mg|
1629970|NCT02126826|2993884|Superiority or Other||Slope|1.0834|||||2-Sided|90.0|0.8655|1.3013||||||Investigation of dose proportionality - dose groups 50mg to 200mg|
1629971|NCT02126826|2993884|Superiority or Other||Slope|0.9511|||||2-Sided|90.0|0.7654|1.1367||||||Investigation of dose proportionality - dose groups 50mg to 300mg|
1629972|NCT02126826|2993886|Superiority or Other||Slope|1.0171|||||2-Sided|90.0|0.8378|1.1964||||||Investigation of dose proportionality - dose groups 50mg to 200mg|
1629973|NCT02126826|2993886|Superiority or Other||Slope|0.7865|||||2-Sided|90.0|0.6193|0.9537||||||Investigation of dose proportionality - dose groups 50mg to 300mg|
1629974|NCT02126670|2993893|Superiority or Other|||||||0.799|||||||Chi-squared||||
1629975|NCT02125734|2993927|Superiority or Other||Mean Difference (Net)|0.081||||0.0017|2-Sided|95.0|0.031|0.13|||ANCOVA||||
1629976|NCT02125461|2993941|Superiority||Hazard Ratio (HR)|0.94||||0.626|2-Sided|95.0|0.75|1.19||Analysis performed using a stratified log rank test adjusting for age at randomization (<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for chest pain. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.|
1629977|NCT02125461|2993941|Superiority||Hazard Ratio (HR)|0.75||||0.048|2-Sided|95.0|0.56|1.0||Analysis performed using a stratified log rank test adjusting for age at randomization (<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for hemoptysis. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.|
1629978|NCT02125461|2993941|Superiority||Hazard Ratio (HR)|0.91||||0.38|2-Sided|95.0|0.74|1.12||Analysis performed using a stratified log rank test adjusting for age at randomization (<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for cough. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.|
1630001|NCT02124161|2994028|Superiority or Other||Percentage Difference|-3.9||||0.143|2-Sided|95.0|-9.1|1.3|||Chan and Zhang method|||Serotype 23F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1629979|NCT02125461|2993941|Superiority||Hazard Ratio (HR)|1.06||||0.522|2-Sided|95.0|0.88|1.29||Analysis performed using a stratified log rank test adjusting for age at randomization (<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||Treatment comparison for dyspnea. The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.|
1629980|NCT02125461|2993942|Superiority||Hazard Ratio (HR)|0.95||||0.664|2-Sided|95.0|0.77|1.18||Analysis performed using a stratified log rank test adjusting for age at randomization (<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|Log Rank|||The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.|
1629981|NCT02125461|2993943|Superiority||Hazard Ratio (HR)|0.58|||<|0.0001|2-Sided|95.0|0.46|0.73|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|
1629982|NCT02125461|2993944|Superiority|||||||0.005||||||P-value generated based on z-test where z-test statistic is the ratio of the log-transformed ratio of the cumulative hazards in the two treatment arms divided by the square root of the variance.|z-test|The variance was estimated using the delta method and Greenwood's formula.|||
1629983|NCT02125461|2993945|Superiority||Hazard Ratio (HR)|0.53|||<|0.0001|2-Sided|95.0|0.41|0.68|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|
1629984|NCT02125461|2993949|Superiority||||||<|0.001|||||||Fisher Exact|||Analysis performed using Fisher's exact test with mid p-value modification by subtracting half of the probability of the observed table from Fisher's p-value.|
1629985|NCT02125461|2993950|Superiority||Hazard Ratio (HR)|0.68||||0.00251|2-Sided|95.0|0.53|0.87|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|
1629986|NCT02125461|2993951|Superiority||Hazard Ratio (HR)|0.52|||<|0.0001|2-Sided|95.0|0.42|0.65|||Log Rank|||Analysis performed using a stratified log rank test adjusting for age at randomization (<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.|
1629987|NCT02124512|2994006|Superiority|||||||0.12||||||unpaired Student's t-test|t-test, 2 sided|||Treatment difference (change in placebo pre- and post-treatment versus change in rifaximin pre- and post-treatment).|
1629988|NCT02124512|2994007|Superiority||||||>|0.05||||||The p-value was calculated to be >0.05.|ANOVA|||Comparison of the pre- and post-treatment timecourse between untreated and rifaximin-treated participants.|
1629989|NCT02124460|2994013|Superiority or Other||Mean Difference (Net)|-0.21||||0.0792|2-Sided|95.0|-0.45|0.03|||Linear repeated measures|Multiple imputation used for missing data at follow-up.|||
1629990|NCT02124460|2994014|Superiority or Other||Mean Difference (Final Values)|0.32||||0.0113|2-Sided|95.0|0.07|0.56|||Linear repeated measures|Multiple imputation used for missing data at follow-up.|||
1629991|NCT02124460|2994015|Superiority or Other||Mean Difference (Net)|0.18||||0.3043|2-Sided|95.0|-0.16|0.53|||Linear repeated measures|Multiple imputation used for missing data at follow-up.|||
1629992|NCT02124460|2994016|Superiority or Other||Mean Difference (Net)|0.42|||<|0.0001|2-Sided|95.0|0.22|0.62||Multiple imputation used for missing data at follow-up.|Linear repeated measures||||
1629993|NCT02124460|2994017|Superiority or Other||Mean Difference (Net)|-0.5||||0.0016|2-Sided|95.0|-0.81|-0.19|||Linear repeated measures|Multiple imputation used for missing data at follow-up.|||
1629994|NCT02124460|2994018|Superiority or Other||Mean Difference (Net)|0.07||||0.14|2-Sided|95.0|-0.02|0.16|||Linear repeated measures|Multiple imputation used for missing data at follow-up|Health Coaching group compared to Enhanced Primary Care.||
1629995|NCT02124460|2994019|Superiority or Other||Mean Difference (Net)|0.89||||0.2306|2-Sided|95.0|-0.56|2.33|||Linear repeated measures|Multiple imputation used for missing data at follow-up|Health Coaching group compared to Enhanced Primary Care||
1629996|NCT02124460|2994020|Superiority or Other||Mean Difference (Net)|-0.02||||0.3928|2-Sided|95.0|-0.08|0.03|||Linear repeated measures|Multiple imputation was used for missing follow-up data.|Health Coaching group compared to Enhanced Primary Care||
1629997|NCT02124161|2994025|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-1.5||||0.627|2-Sided|95.0|-7.2|4.3|||Chan and Zhang method|||Strain B/Massachusetts: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1629998|NCT02124161|2994025|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-1.0||||0.734|2-Sided|95.0|-6.6|4.5|||Chan and Zhang method|||Strain B/Brisbane: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1629999|NCT02124161|2994025|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|-3.8||||0.232|2-Sided|95.0|-9.9|2.4|||Chan and Zhang method|||Strain A/H3N2: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630000|NCT02124161|2994025|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|Percentage Difference|5.1||||0.094|2-Sided|95.0|-0.9|11.0|||Chan and Zhang method|||Strain A/H1N1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630002|NCT02124161|2994028|Superiority or Other||Percentage Difference|0.3||||0.926|2-Sided|95.0|-5.1|5.8|||Chan and Zhang method|||Serotype 19F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630003|NCT02124161|2994028|Superiority or Other||Percentage Difference|-1.8||||0.152|2-Sided|95.0|-4.5|0.7|||Chan and Zhang method|||Serotype 19A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630004|NCT02124161|2994028|Superiority or Other||Percentage Difference|-2.5||||0.233|2-Sided|95.0|-6.6|1.6|||Chan and Zhang method|||Serotype 18C: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630005|NCT02124161|2994028|Superiority or Other||Percentage Difference|-3.7||||0.03|2-Sided|95.0|-7.3|-0.3|||Chan and Zhang method|||Serotype 14: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630006|NCT02124161|2994028|Superiority or Other||Percentage Difference|-6.2||||0.057|2-Sided|95.0|-12.5|0.2|||Chan and Zhang method|||Serotype 9V: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630007|NCT02124161|2994028|Superiority or Other||Percentage Difference|-1.2||||0.648|2-Sided|95.0|-6.3|3.9|||Chan and Zhang method|||Serotype 7F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630008|NCT02124161|2994028|Superiority or Other||Percentage Difference|-1.4||||0.574|2-Sided|95.0|-6.2|3.4|||Chan and Zhang method|||Serotype 6B: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630009|NCT02124161|2994028|Superiority or Other||Percentage Difference|-3.7||||0.044|2-Sided|95.0|-7.5|-0.1|||Chan and Zhang method|||Serotype 6A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630010|NCT02124161|2994028|Superiority or Other||Percentage Difference|1.8||||0.59|2-Sided|95.0|-4.2|7.8|||Chan and Zhang method|||Serotype 5: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630011|NCT02124161|2994028|Superiority or Other||Percentage Difference|-3.5||||0.09|2-Sided|95.0|-7.6|0.6|||Chan and Zhang method|||Serotype 4: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630012|NCT02124161|2994028|Superiority or Other||Percentage Difference|-4.3||||0.105|2-Sided|95.0|-9.6|0.9|||Chan and Zhang method|||Serotype 3: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630013|NCT02124161|2994028|Superiority or Other||Percentage Difference|-2.8||||0.333|2-Sided|95.0|-8.3|2.8|||Chan and Zhang method|||Serotype 1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo – placebo+QIV/13vPnC), expressed as a percentage.|
1630014|NCT02124161|2994030|Superiority or Other||Percentage Difference|0.0|||||2-Sided|95.0|-1.8|1.7||||||SAE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo – placebo+QIV/13vPnC, expressed as a percentage.|
1630015|NCT02124161|2994030|Superiority or Other||Percentage Difference|2.8|||||2-Sided|95.0|-1.9|7.4||||||AE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo – placebo+QIV/13vPnC, expressed as a percentage.|
1630016|NCT02124161|2994033|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||2-Sided|95.0|0.9|1.21||||||Strain B/Massachusetts: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630017|NCT02124161|2994033|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.1|||||2-Sided|95.0|0.95|1.24||||||Strain B/Brisbane: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630018|NCT02124161|2994033|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.2|||||2-Sided|95.0|1.01|1.32||||||Strain A/H3N2: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630019|NCT02124161|2994033|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||2-Sided|95.0|0.88|1.18||||||Strain A/H1N1: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630020|NCT02124161|2994034|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||2-Sided|95.0|0.56|1.03||||||Serotype 23F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630021|NCT02124161|2994034|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||2-Sided|95.0|0.71|1.14||||||Serotype 19F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630046|NCT02123511|2994074|Superiority|||||||0.22|||||||t-test, 1 sided||||
1630022|NCT02124161|2994034|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||2-Sided|95.0|0.72|1.04||||||Serotype 19A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630023|NCT02124161|2994034|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||2-Sided|95.0|0.64|1.06||||||Serotype 18C: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630024|NCT02124161|2994034|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||2-Sided|95.0|0.62|0.92||||||Serotype 14: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630025|NCT02124161|2994034|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||2-Sided|95.0|0.69|1.0||||||Serotype 9V: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630026|NCT02124161|2994034|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||2-Sided|95.0|0.83|1.14||||||Serotype 7F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630027|NCT02124161|2994034|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||2-Sided|95.0|0.64|1.08||||||Serotype 6B: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630028|NCT02124161|2994034|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||2-Sided|95.0|0.53|0.85||||||Serotype 6A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630029|NCT02124161|2994034|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|1.0|||||2-Sided|95.0|0.78|1.18||||||Serotype 5: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630030|NCT02124161|2994034|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||2-Sided|95.0|0.55|0.91||||||Serotype 4: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630031|NCT02124161|2994034|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||2-Sided|95.0|0.7|0.98||||||Serotype 3: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630032|NCT02124161|2994034|Non-Inferiority or Equivalence|The criterion for noninferiority was the lower bound of the 2-sided 95% CI for the GMT ratio was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||2-Sided|95.0|0.74|1.12||||||Serotype 1: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo – placebo+QIV/13vPnC).|
1630033|NCT02123849|2994050|Non-Inferiority|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.06|||||||t-test, 1 sided||||
1630034|NCT02123849|2994051|Non-Inferiority|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.97|||||||t-test, 1 sided||||
1630035|NCT02123849|2994052|Non-Inferiority|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.97|||||||t-test, 1 sided||||
1630036|NCT02123849|2994053|Other|||||||0.42|||||||t-test, 2 sided||||
1630037|NCT02123849|2994054|Other|||||||1|||||||Fisher Exact||||
1630038|NCT02123849|2994055|Other|||||||0.61|||||||t-test, 2 sided||||
1630039|NCT02123849|2994056|Other|||||||0.84|||||||t-test, 2 sided||||
1630040|NCT02123849|2994057|Non-Inferiority|The non-inferiority margin is 10% of the coefficient of variation (i.e., standard deviation divided by mean) which means that the changes in the signature score in the intermittent arm is no less than 90% of the coefficient of variation of the changes in the signature score in the continuous arm.||||||0.04|||||||t-test, 1 sided||||
1630041|NCT02123511|2994069|Superiority|||||||0.3824|||||||Wilcoxon (Mann-Whitney)||||
1630042|NCT02123511|2994070|Superiority|||||||0.48|||||||t-test, 1 sided||||
1630043|NCT02123511|2994071|Superiority|||||||0.17|||||||t-test, 1 sided||||
1630044|NCT02123511|2994072|Superiority|||||||0.95|||||||t-test, 1 sided||||
1630045|NCT02123511|2994073|Superiority|||||||0.02|||||||t-test, 1 sided||||
1630051|NCT02123251|2994099|Superiority or Other||Mean Difference (Final Values)|2.1188|Standard Error of the Mean|1.031||0.0399|2-Sided|95.0|0.0981|4.1395|||Generalized Estimating Equation Model|The effect of age and gender is adjusted in the GEE model.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|The average change in scores over time for the intervention group was compared to that of the control group. The difference in the average changes is referred to as the difference-in-differences values which was assessed for significance at p=0.05. Null assumed no group difference in the Physical Component Summary measure of SF-36v2 from baseline to midpoint. Generalized estimating equation (GEE) modeling was used to examine changes in health measures between groups at different time points.|
1630052|NCT02123251|2994100|Superiority or Other||Mean Difference (Final Values)|0.6403|Standard Error of the Mean|0.3148||0.042|2-Sided|95.0|0.0233|1.2572|||Generalized Estimating Equation Model||The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|The average change in scores over time for the intervention group was compared to that for the control group. The difference in these average changes is referred to as the difference-in-differences values which was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the General Diet subscale from baseline to endpoint between groups. Generalized estimating equation modeling was used to examine changes in SDSCA between groups at different time points.|
1630053|NCT02123251|2994101|Superiority or Other||||||>|0.05|||||||standard diffs-in-diffs model|||A standard diffs-in-diffs model was utilized to estimate the causal effect of the intervention on medical costs per patient/day. The average change in cost over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no difference in the cost per patient per day from baseline to endpoint between groups.|
1630054|NCT02123251|2994102|Superiority or Other||Mean Difference (Final Values)|0.7177|Standard Error of the Mean|1.0433||0.4915|2-Sided|95.0|-1.3272|2.7626|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.|
1630055|NCT02123251|2994103|Superiority or Other||Mean Difference (Final Values)|0.9097|Standard Error of the Mean|5.2351||0.862|2-Sided|95.0|-9.3509|11.1702|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.|
1630056|NCT02123251|2994104|Superiority or Other||Mean Difference (Final Values)|-17.787|Standard Error of the Mean|28.5519||0.5333|2-Sided|95.0|-73.7478|38.1737|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.|
1630057|NCT02123251|2994105|Superiority or Other||Mean Difference (Final Values)|-1.3432|Standard Error of the Mean|7.7086||0.8617|2-Sided|95.0|-16.4517|13.7653|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.|
1630058|NCT02123251|2994106|Superiority or Other||Mean Difference (Final Values)|-1.0893|Standard Error of the Mean|1.2622||0.3881|2-Sided|95.0|-3.5632|1.3846|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, gender, race, and hypertension at baseline.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.|
1630059|NCT02123251|2994107|Superiority or Other||Mean Difference (Final Values)|-2.2916|Standard Error of the Mean|1.9571||0.2416|2-Sided|95.0|-6.1274|1.5442|||Generalized Estimating Equation Model||The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.|
1630375|NCT02115308|2994937|Superiority|||||||0.017||||||non-adjusted|paired, t-test|||REST-TO-REGADENOSON STRESS|
1630060|NCT02123251|2994108|Superiority or Other||Mean Difference (Final Values)|0.41|Standard Error of the Mean|0.2139||0.0553|2-Sided|95.0|-0.0092|0.8293|||Generalized Estimating Equation Model|The analysis adjusted for the effects of age, race, gender, and baseline hypertension.|The estimates denote the differences between longitudinal changes within the treatment group and longitudinal changes within the control group.|Generalized estimating equation (GEE) modeling was used to examine the pre- and post-intervention changes between groups due to interventions in biometric indicators. The average change in scores over time for the intervention group was compared to that for the control group. The difference-in-differences values was assessed for significance at p = 0.05. Null hypothesis assumed no differences in the biometric measure from baseline to endpoint between groups.|
1630061|NCT02122887|2994124|Equivalence|we compared participants levels of empathy (in their interaction with an outgroup member in trail 2) in an interaction test between perspective-taking levels and group|Mean Difference (Final Values)|0.04|||>|0.05|2-Sided|95.0|||||ANOVA||||
1630062|NCT02122887|2994125|Equivalence|we compared participants levels of tension (in their interaction with an outgroup member in trail 2) in an interaction test between perspective-taking levels and group|Mean Difference (Final Values)|0.65|||>|0.05|2-Sided|95.0|||||ANOVA|df=1|||
1630063|NCT02122887|2994126|Other|χ² (1) =4.57, Cramer’s V=.24|||||<|0.05|||||||Chi-squared|||we hypothesised that following intervention, those undergoing intervention will be more likely to see justice on both sides, compared to control group|
1630064|NCT02122796|2994132|Superiority or Other||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student’s t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student’s t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student’s t tests.|||
1630065|NCT02122796|2994134|Superiority or Other||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student’s t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student’s t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student’s t tests.|||
1630066|NCT02122796|2994135|Superiority or Other||||||<|0.01||||||Means of pre- and post-treatment measurements were compared using paired, two-sided Student’s t tests. P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student’s t tests.|t-test, 2 sided|P values were calculated comparing acupuncture and control mean change scores using unpaired two-sided Student’s t tests.|||
1630067|NCT02122770|2994155|Superiority||Geometric LS Mean Ratio|100.89|||||2-Sided|90.0|91.14|111.68||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.|
1630068|NCT02122770|2994155|Superiority||Geometric LS Mean Ratio|130.16|||||2-Sided|90.0|106.99|158.35||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference|
1630069|NCT02122770|2994155|Superiority||Geometric LS Mean Ratio|122.95|||||2-Sided|90.0|112.13|134.82||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.|
1630070|NCT02122770|2994156|Superiority||Geometric LS Mean Ratio|101.36|||||2-Sided|90.0|90.72|113.23||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.|
1630071|NCT02122770|2994156|Superiority||Geometric LS Mean Ratio|130.16|||||2-Sided|90.0|106.99|158.35||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference|
1630072|NCT02122770|2994156|Superiority||Geometric LS Mean Ratio|121.57|||||2-Sided|90.0|110.92|133.24||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.|
1630073|NCT02122770|2994157|Superiority||Geometric LS Mean Ratio|77.26|||||2-Sided|90.0|55.19|108.17||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.|
1630074|NCT02122770|2994157|Superiority||Geometric LS Mean Ratio|159.55|||||2-Sided|90.0|89.97|282.96||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference|
1630075|NCT02122770|2994157|Superiority||Geometric LS Mean Ratio|113.05|||||2-Sided|90.0|85.35|149.74||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.|
1630076|NCT02122770|2994158|Superiority||Geometric LS Mean Ratio|110.66|||||2-Sided|90.0|102.53|119.43||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.|
1630077|NCT02122770|2994159|Superiority||Geometric LS Mean Ratio|110.21|||||2-Sided|90.0|102.34|118.69||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.|
1630376|NCT02115308|2994937|Superiority|||||||0.001|||||||paired, t-test|non-adjusted||REST-TO-REGADENOSON STRESS|
1630078|NCT02122770|2994160|Superiority||Geometric LS Mean Ratio|98.75|||||2-Sided|90.0|82.6|118.05||||||Natural-log transformed pharmacokinetic parameters were fit using a mixed effects model with study day as a fixed effect and participant as a random effect. Geometric least square (LS) means and geometric LS mean ratio were back-transformed least squares mean and treatment mean difference.|
1630079|NCT02122380|2994170|Superiority|||||||0.943|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in vascular function between sitagliptin and placebo treatments. The test was performed with a significance level of 0.05 (two sided).|
1630080|NCT02122380|2994171|Superiority|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in the mass of visceral adipose tissue after sitagliptin vs. placebo. The test was performed with a significance level of 0.05 (two sided).|
1630081|NCT02122380|2994172|Superiority|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in blood glucose levels between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided).|
1630082|NCT02122380|2994173|Superiority|||||||0.054|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of early insulin secretion between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided).|
1630083|NCT02122380|2994174|Superiority|||||||0.918|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of mean growth hormone (GH) levels between sitagliptin and placebo. The test was performed with a significance level of 0.05 (two sided). A sample size of 16 participants was needed to provide 93% power to detect a difference in GH means of 0.5 mcg/L.|
1630084|NCT02121795|2994248|Non-Inferiority|Noninferiority was assessed using a conventional 95.002% confidence interval (CI) approach, with a noninferiority margin of 10%.|Percentage difference|1.3||||0.5|2-Sided|95.002|-2.5|5.1|||Cochran-Mantel-Haenszel|P-value was from Cochran-Mantel-Haenszel (CMH) test stratified by third agent.|Difference in percentages of virologic success between treatment groups and its 95.002% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by the third agent stratum.||
1630085|NCT02121756|2994249|Other|||||||0.562|||||||Mixed Models Analysis||||
1630086|NCT02121756|2994250|Other|||||||0.6121|||||||Mixed Models Analysis||||
1630087|NCT02121756|2994251|Other|||||||0.3317|||||||Mixed Models Analysis||||
1630088|NCT02121756|2994252|Other|||||||0.983|||||||Mixed Models Analysis||||
1630089|NCT02121756|2994253|Other|||||||0.7598|||||||Mixed Models Analysis||||
1630090|NCT02121756|2994254|Other|||||||0.2343|||||||Mixed Models Analysis||||
1630091|NCT02121756|2994255|Other|||||||0.7376|||||||Mixed Models Analysis||||
1630092|NCT02121756|2994256|Other|||||||0.0315|||||||Mixed Models Analysis||||
1630093|NCT02121756|2994257|Other|||||||0.2075|||||||Mixed Models Analysis||||
1630094|NCT02121756|2994258|Other|||||||0.7556|||||||Mixed Models Analysis||||
1630095|NCT02121756|2994260|Other|||||||0.4548|||||||Mixed Models Analysis||||
1630096|NCT02121756|2994261|Other|The IL-6 is measured in pg/ml and the median change is shown in pg/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma IL-6.||||||0.5027|||||||Regression, Linear||||
1630097|NCT02121756|2994262|Other|The sCD163 is measured in ng/ml and the median change is shown in ng/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma sCD163.||||||0.0869|||||||Regression, Linear||||
1630098|NCT02121756|2994263|Other|The sCD14 is measured in pg/ml and the median change is shown in pg/ml. the linear regression for the between arm comparison of baseline to week 12 change was performed using log10 transformed plasma sCD14||||||0.822|||||||Regression, Linear||||
1630099|NCT02121535|2994264|Non-Inferiority or Equivalence|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|104.37|||||2-Sided|90.0|102.68|106.1|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.|
1630100|NCT02121535|2994265|Non-Inferiority or Equivalence|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|104.3|||||2-Sided|90.0|102.53|106.1|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.|
1630101|NCT02121535|2994266|Non-Inferiority or Equivalence|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|110.16|||||2-Sided|90.0|106.87|113.54|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.|
1630102|NCT02121535|2994267|Non-Inferiority or Equivalence|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|100.07|||||2-Sided|90.0|98.45|101.72|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.|
1630103|NCT02121535|2994268|Non-Inferiority or Equivalence|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|99.5|||||2-Sided|90.0|98.08|100.94|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.|
1630104|NCT02121535|2994269|Non-Inferiority or Equivalence|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|99.42|||||2-Sided|90.0|97.94|100.93|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.|
1630105|NCT02121535|2994270|Non-Inferiority or Equivalence|To determine whether the 2-sided 90% CI for the intra-subject ratio of the AUC0-∞ were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|100.24|||||2-Sided|90.0|96.8|103.8|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0--∞ was a mixed effect model on the logarithmic scale.|
1630380|NCT02114892|2994963|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1630106|NCT02121535|2994271|Non-Inferiority or Equivalence|To determine whether the 2-sided 90% CI for the intra-subject ratio of the Cmax were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|103.77|||||2-Sided|90.0|97.03|110.99|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of Cmax was a mixed effect model on the logarithmic scale.|
1630107|NCT02121535|2994272|Non-Inferiority or Equivalence|To determine whether the 2-sided 90% confidence interval (CI) for the intra-subject ratio of the AUC0-tz were contained in the acceptance range of 80% to 125% for bioequivalence.|Adjusted Mean Ratio|101.97|||||2-Sided|90.0|98.94|105.08|||||Adjusted Mean Ratio (Test/Reference)|The statistical model used for the analysis of AUC0-tz was a mixed effect model on the logarithmic scale.|
1630108|NCT02121509|2994275|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.79|Standard Error of the Mean|1.04||0.0001|2-Sided|90.0|90.33|103.7|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1500 fed/ L+M 1500 fed)||
1630109|NCT02121509|2994275|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.07|Standard Error of the Mean|1.05|<|0.0001|2-Sided|90.0|94.2|110.59|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)||
1630110|NCT02121509|2994276|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|106.33|Standard Error of the Mean|1.034||0.0002|2-Sided|90.0|100.268|112.763|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1500 fed/ L+M 1500 fed)||
1630111|NCT02121509|2994276|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.45|Standard Error of the Mean|1.035|<|0.0001|2-Sided|90.0|95.748|107.487|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)||
1630112|NCT02121509|2994277|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|113.91|Standard Error of the Mean|1.027||0.0018|2-Sided|90.0|108.749|119.318|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1500 fed/ L+M 1500 fed)||
1630113|NCT02121509|2994277|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|105.1|Standard Error of the Mean|1.057||0.0013|2-Sided|90.0|95.829|115.269|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)||
1630114|NCT02121509|2994278|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|96.36|Standard Error of the Mean|1.04||0.0002|2-Sided|90.0|89.96|103.22|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1500 fed/ L+M 1500 fed)||
1630115|NCT02121509|2994278|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|102.03|Standard Error of the Mean|1.05||0.0001|2-Sided|90.0|94.03|110.72|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)||
1630116|NCT02121509|2994279|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|106.71|Standard Error of the Mean|1.051||0.004|2-Sided|90.0|97.614|116.658|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1500 fed/ L+M 1500 fed)||
1630117|NCT02121509|2994279|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|106.22|Standard Error of the Mean|1.046||0.0004|2-Sided|90.0|98.449|114.614|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)||
1630118|NCT02121509|2994280|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.45|Standard Error of the Mean|1.026|<|0.0001|2-Sided|90.0|96.99|106.121|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1500 fed/ L+M 1500 fed)||
1630119|NCT02121509|2994280|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.79|Standard Error of the Mean|1.023|<|0.0001|2-Sided|90.0|98.938|106.789|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’|Ratio of (FDC 1500 fasted/ L+M 1500 fasted)||
1630381|NCT02114892|2994964|Superiority or Other (legacy)|||||||0.557|||||||Wilcoxon (Mann-Whitney)||||
1630120|NCT02121483|2994286|Superiority or Other||Slope|0.8554|Standard Error of the Mean|0.1481|||2-Sided|95.0|0.5504|1.1603|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and Cmax. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.||
1630121|NCT02121483|2994287|Superiority or Other||Slope|0.9597|Standard Error of the Mean|0.1088|||2-Sided|95.0|0.7356|1.1838|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-tz. Based on the estimate for the slope parameter β, a 2-sided 95% CI for the slope was computed.||
1630122|NCT02121483|2994288|Superiority or Other||Slope|0.949|Standard Error of the Mean|0.1075|||2-Sided|95.0|0.7276|1.1704|||||Dose proportionality was assessed based on a power model that describes the functional relationship between the dose and AUC0-inf. Based on the estimate for the slope parameter β, a 2-sided 95% confidence interval (CI) for the slope was computed.||
1630123|NCT02120950|2994297|Superiority or Other||Difference %|-0.6||||0.8423|2-Sided|95.0|-6.3|5.1||The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12.|Cochran-Mantel-Haenszel||CI is based on the treatment difference in % (AFL-sham – AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12.||
1630124|NCT02120950|2994298|Superiority or Other||LS mean difference|-0.7||||0.5069|2-Sided|95.0|-2.9|1.4|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham – AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with values for NEI VFQ-25 score at baseline and Week 52.|
1630125|NCT02120950|2994299|Superiority or Other||LS mean difference|1.1||||0.8355|2-Sided|95.0|-9.2|11.3|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham – AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with values for CST at baseline and Week 52. Baseline values were not carried forward.|
1630126|NCT02120950|2994300|Superiority or Other||LS mean difference|-0.1||||0.7109|2-Sided|95.0|-0.9|0.6|||ANCOVA||Point estimate, 95% CI and p-value are based on difference (AFL-sham – AFL-PDT) of LS mean changes using an ANCOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects, baseline value as covariate.|The analysis population included only subjects with leakage in FA at baseline and Week 52. Baseline values were not carried forward.|
1630127|NCT02120950|2994301|Superiority or Other||treatment difference in %|-6.0||||0.3244|2-Sided|95.0|-17.8|5.9|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham – AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12||
1630128|NCT02120950|2994302|Superiority or Other||treatment difference in %|-0.6||||0.7402|2-Sided|95.0|-4.3|3.1|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham – AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 15|
1630129|NCT02120950|2994302|Superiority or Other||treatment difference in %|0.6||||0.7569|2-Sided|95.0|-3.4|4.7|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham – AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 10|
1630130|NCT02120950|2994302|Superiority or Other||treatment difference in %|1.7||||0.5372|2-Sided|95.0|-3.7|7.2|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham – AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Lost ≥ 5|
1630131|NCT02120950|2994303|Superiority or Other||treatment difference in %|-4.0||||0.4556|2-Sided|95.0|-14.5|6.5|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham – AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 15|
1630132|NCT02120950|2994303|Superiority or Other||treatment difference in %|-2.2||||0.6877|2-Sided|95.0|-13.1|8.6|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham – AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 10|
1630133|NCT02120950|2994303|Superiority or Other||treatment difference in %|-5.6||||0.2348|2-Sided|95.0|-14.9|3.7|||Cochran-Mantel-Haenszel|The p-value is calculated from the 2-sided Cochran-Mantel-Haenszel test adjusted by ethnicity and qualification for rescue therapy at Week 12|CI is based on the treatment difference in % (AFL-sham – AFL-PDT) using the Mantel-Haenszel weighting scheme adjusted by ethnicity and qualification for rescue therapy at Week 12|Category of Gained ≥ 5|
1630134|NCT02120950|2994306|Superiority or Other||LS mean difference|0.1||||0.164|2-Sided|95.0|-0.1|0.3|||ANCOVA||Point estimate, 95% CI and p-value are based on treatment difference (AFL-sham – AFL-PDT) of the LS mean changes using an ANOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects.||
1630135|NCT02120950|2994307|Superiority or Other||LS mean difference|0.1||||0.0682|2-Sided|95.0|0.0|0.2|||ANCOVA||Point estimate, 95% CI and p-value are based on treatment difference (AFL-sham – AFL-PDT) of the LS mean changes using an ANOVA model with treatment group and ethnicity and qualification for rescue therapy at Week 12 as fixed effects.||
1630136|NCT02120950|2994309|Superiority or Other||treatment difference in %|0.6||||0.7402|2-Sided|95.0|-3.1|4.3|||Cochran-Mantel-Haenszel||||
1630138|NCT02120898|2994314|Superiority||Percentage difference|0.14||||0.0318|2-Sided|90.0|-6.08|6.35||Threshold for significance at 0.05 level.|Fisher Exact|||Analysis was performed using 90% Wald's CI with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.|
1630139|NCT02120898|2994315|Equivalence|90% CI interval was -0.20 to +0.20 for therapeutic equivalence.|Percentage difference|-1.16||||0.0702|2-Sided|90.0|-7.93|5.62|||Fisher Exact|||Analysis was performed using 90% Wald's confidence interval (CI) with a continuity correction or the difference (generic imiquimod - Zyclara) in complete clearance rates.|
1630140|NCT02120833|2994375|Superiority or Other||Mean Difference (Final Values)|7.43|Standard Error of the Mean|3.34||0.0313|2-Sided|95.0|0.7|14.15||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630141|NCT02120833|2994375|Superiority or Other|||||||0.0712||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630142|NCT02120833|2994375|Superiority or Other||||||<|0.0001||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630143|NCT02120833|2994376|Superiority or Other||Mean Difference (Final Values)|4.56|Standard Error of the Mean|3.48||0.1968|2-Sided|95.0|-2.46|11.58||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630144|NCT02120833|2994376|Superiority or Other|||||||0.0172||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630145|NCT02120833|2994376|Superiority or Other||||||<|0.0001||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630146|NCT02120833|2994377|Superiority or Other||Mean Difference (Final Values)|8.48|Standard Error of the Mean|3.54||0.0213|2-Sided|95.0|1.33|15.63||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630147|NCT02120833|2994377|Superiority or Other|||||||0.0772||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630148|NCT02120833|2994377|Superiority or Other||||||<|0.0001||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630149|NCT02120833|2994378|Superiority or Other||Mean Difference (Final Values)|8.99|Standard Error of the Mean|4.23||0.0394|2-Sided|95.0|0.46|17.52||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630150|NCT02120833|2994378|Superiority or Other|||||||0.0696||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630151|NCT02120833|2994378|Superiority or Other||||||<|0.0001||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630152|NCT02120833|2994379|Superiority or Other||Mean Difference (Final Values)|9.3|Standard Error of the Mean|3.98||0.0241|2-Sided|95.0|1.28|17.32||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630153|NCT02120833|2994379|Superiority or Other|||||||0.2386||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630154|NCT02120833|2994379|Superiority or Other||||||<|0.0001||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630155|NCT02120833|2994380|Superiority or Other||Mean Difference (Final Values)|5.59|Standard Error of the Mean|4.71||0.2409|2-Sided|95.0|-3.88|15.07||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630156|NCT02120833|2994380|Superiority or Other|||||||0.0049||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630157|NCT02120833|2994380|Superiority or Other||||||<|0.0001||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630158|NCT02120833|2994381|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.28||0.1561|2-Sided|95.0|-0.97|0.16||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630159|NCT02120833|2994381|Superiority or Other|||||||0.0065||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630377|NCT02115113|2994950|Superiority or Other||Mean Difference (Net)|5.24|Standard Error of the Mean|5.01||0.3013|2-Sided|95.0|-4.86|15.34|||ANOVA||||
1630160|NCT02120833|2994381|Superiority or Other||||||<|0.0001||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630161|NCT02120833|2994382|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.21||0.09|2-Sided|95.0|-0.8|0.06||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630162|NCT02120833|2994382|Superiority or Other|||||||0.0244||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630163|NCT02120833|2994382|Superiority or Other||||||<|0.0001||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630164|NCT02120833|2994383|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.19||0.8037|2-Sided|95.0|-0.42|0.33||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630165|NCT02120833|2994383|Superiority or Other|||||||0.0317||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630166|NCT02120833|2994383|Superiority or Other|||||||0.0001||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630167|NCT02120833|2994384|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.07||0.3599|2-Sided|95.0|-0.08|0.22||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630168|NCT02120833|2994384|Superiority or Other|||||||0.6083||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630169|NCT02120833|2994384|Superiority or Other|||||||0.7842||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630170|NCT02120833|2994385|Superiority or Other||Mean Difference (Final Values)|-0.94|Standard Error of the Mean|0.78||0.2349|2-Sided|95.0|-2.52|0.64||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630171|NCT02120833|2994385|Superiority or Other|||||||0.0476||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630172|NCT02120833|2994385|Superiority or Other||||||<|0.0001||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630173|NCT02120833|2994386|Superiority or Other||Mean Difference (Final Values)|-1.6|Standard Error of the Mean|0.67||0.0216|2-Sided|95.0|-2.95|-0.25||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630174|NCT02120833|2994386|Superiority or Other|||||||0.2447||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630175|NCT02120833|2994386|Superiority or Other||||||<|0.0001||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630176|NCT02120833|2994387|Superiority or Other||Mean Difference (Final Values)|-0.83|Standard Error of the Mean|0.56||0.1485|2-Sided|95.0|-1.98|0.31||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630177|NCT02120833|2994387|Superiority or Other|||||||0.6118||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630178|NCT02120833|2994387|Superiority or Other||||||<|0.0001||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630179|NCT02120833|2994388|Superiority or Other||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.43||0.3686|2-Sided|95.0|-1.27|0.48||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630180|NCT02120833|2994388|Superiority or Other|||||||0.6063||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630181|NCT02120833|2994388|Superiority or Other|||||||0.0003||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630182|NCT02120833|2994389|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.22||0.7698|2-Sided|95.0|-0.5|0.37|||ANCOVA|The significance threshold level was 0.05 (two-sided).||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630183|NCT02120833|2994389|Superiority or Other|||||||0.0213||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630184|NCT02120833|2994389|Superiority or Other|||||||0.0004||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630185|NCT02120833|2994390|Superiority or Other||Mean Difference (Final Values)|-1.25|Standard Error of the Mean|0.62||0.051|2-Sided|95.0|-2.51|0.01||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment and study site as factors, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1630186|NCT02120833|2994390|Superiority or Other|||||||0.436||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630187|NCT02120833|2994390|Superiority or Other||||||<|0.0001||||||The significance level threshold level was 0.05 (two-sided).|One-sample t-test|Adjusted by study site.||The null hypothesis was no difference versus baseline. The alternative hypothesis was a difference versus baseline.|
1630188|NCT02120794|2994394|Non-Inferiority|non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).|Mean Difference (Net)|0.26|||||2-Sided|95.0|0.125|0.395|||||||
1630189|NCT02120716|2994395|Superiority||Odds Ratio (OR)|11.7|||<|0.015|2-Sided|95.0|4.2|33.0|||Regression, Logistic|||The reported percentages were captured at two separate time points (baseline, and at 4-Month Follow-Up).|
1630190|NCT02120716|2994396|Other|Logistic regression analysis.|Odds Ratio (OR)|5.5||||0.13|2-Sided|95.0|0.6|51.2|||Regression, Logistic||||
1630191|NCT02120664|2994398|Superiority or Other||Coefficient of Variation|6.69|||||2-Sided||||||||||
1630192|NCT02120664|2994398|Superiority or Other||Coefficient of Variation|2.53|||||2-Sided||||||||||
1630193|NCT02120664|2994399|Superiority or Other||R squared|0.907|||||2-Sided||||||||||
1630194|NCT02120456|2994405|Superiority||Ratio of clearance rates|0.99||||0.95|2-Sided|95.0|0.66|1.47|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.|
1630195|NCT02120456|2994405|Superiority||Ratio of clearance rates|2.84||||0.004|2-Sided|95.0|1.35|7.74|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.|
1630196|NCT02120456|2994405|Superiority||Ratio of clearance rates|2.88||||0.003|2-Sided|95.0|1.36|7.85|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.|
1630197|NCT02120456|2994406|Superiority||Ratio of clearance rates|0.95||||0.93|2-Sided|95.0|0.31|2.89|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.|
1630198|NCT02120456|2994406|Superiority||Ratio of clearance rates|1.0||||1|2-Sided|95.0|0.28|4.51|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.|
1630199|NCT02120456|2994406|Superiority||Ratio of clearance rates|1.05||||0.94|2-Sided|95.0|0.3|4.73|||Log binomial regression|||Log binomial regression with factors treatment group and baseline AK count as a covariate.|
1630200|NCT02120456|2994407|Superiority||Rate ratio|1.26||||0.058|2-Sided|95.0|0.99|1.6|||Negative binominal regression||||
1630201|NCT02120456|2994407|Superiority||Rate ratio|0.56|||<|0.001|2-Sided|95.0|0.44|0.73|||Negative binominal regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.|
1630202|NCT02120456|2994407|Superiority||Rate ratio|0.45|||<|0.001|2-Sided|95.0|0.34|0.58|||Negative binominal regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.|
1630203|NCT02120417|2994418|Superiority or Other||Hazard Ratio (HR)|0.932||||0.762|2-Sided|80.0|0.694|1.252|||Log Rank|The P-value was analyzed by Log-Rank Test stratified by Hormone Receptor Status.|||
1630204|NCT02120027|2994454|Superiority or Other||Odds Ratio (OR)|1.153||||0.567|2-Sided|95.0|0.73|1.81|||Cochran-Mantel-Haenszel||||
1630205|NCT02120027|2994455|Superiority or Other||Odds Ratio (OR)|1.339||||0.272|2-Sided|95.0|0.79|2.26|||Cochran-Mantel-Haenszel||||
1630206|NCT02120027|2994456|Superiority or Other||Odds Ratio (OR)|1.032||||0.872|2-Sided|95.0|0.7|1.53|||Cochran-Mantel-Haenszel||||
1630207|NCT02120027|2994457|Superiority or Other||Odds Ratio (OR)|1.28||||0.193|2-Sided|95.0|0.88|1.86|||Cochran-Mantel-Haenszel||||
1630208|NCT02120027|2994458|Superiority or Other||Odds Ratio (OR)|0.986||||0.949|2-Sided|95.0|0.64|1.53|||Cochran-Mantel-Haenszel||||
1630209|NCT02119871|2994471|Superiority||Median Difference (Final Values)|4.0||||1|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1630210|NCT02119871|2994472|Superiority||Median Difference (Final Values)|10.0||||0.656|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1630211|NCT02119871|2994473|Superiority||Median Difference (Final Values)|14.0||||1|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1630212|NCT02119676|2994479|Other||Hazard Ratio (HR)|0.77||||0.136|2-Sided|95.0|0.48|1.23||1-sided|Log Rank|Log rank test stratified by geographical region.|Estimated using Cox regression model with Efron’s method used for ties, stratified by geographical region||
1630213|NCT02119676|2994479|Other||Hazard Ratio (HR)|1.04||||0.588|2-Sided|95.0|0.73|1.49||1-sided|Log Rank|Log-rank test stratified by modified Glasgow Prognostic Score (mGPS) and geographical region.|Estimated using a Cox regression model with Efron’s method used for ties, stratified by mGPS score and geographical region||
1630214|NCT02119663|2994485|Other||Hazard Ratio (HR)|1.584|||||2-Sided|95.0|0.886|2.83|||||||
1630215|NCT02119650|2994490|Other||Hazard Ratio (HR)|0.877||||0.7562|2-Sided|80.0|0.509|1.51|||Log Rank|The 2-sided p-value was calculated based on the log-rank test and stratified by modified Glasgow Prognostic Score (mGPS).|||
1630246|NCT02118896|2994580|Superiority or Other||Kaplan-Meier Method|1.0|||||2-Sided|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.|
1630378|NCT02114892|2994961|Superiority or Other (legacy)|||||||0.672|||||||Wilcoxon (Mann-Whitney)||||
1630216|NCT02119325|2994515|Superiority or Other||Difference in Adjusted Mean|-6.79||||0.6116|2-Sided|95.0|-34.02|20.44||Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.|ANOVA||Difference is test minus placebo such that a positive difference means the test has higher Cmax|"H0: There was no difference in the post prandial triglyceride peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with triglyceride as dependent variable, treatment and period as fixed effects and subject as random effect."|
1630217|NCT02119325|2994516|Superiority or Other||Difference in Adjusted Mean|-4.64||||0.0487|2-Sided|95.0|-9.26|-0.03||Statistical significance at the 5% level was required for both co-primary endpoints in order to progress to formal assessment of secondary endpoints.|ANOVA||Difference is test minus placebo such that a positive difference means the test has higher Cmax|"H0: There was no difference in the post prandial glucose peak for participants with IFG between the test and placebo.~The primary parameter was analysed using a mixed effects model with glucose as dependent variable, treatment and period as fixed effects and subject as random effect."|
1630218|NCT02119286|2994525|Superiority or Other||Least squared mean difference|0.135|||<|0.001|2-Sided|95.0|0.103|0.167|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)|||
1630219|NCT02119286|2994525|Superiority or Other||Least squared mean difference|0.147|||<|0.001|2-Sided|95.0|0.114|0.179|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)|||
1630220|NCT02119286|2994526|Superiority or Other||Least squared mean difference|0.111|||<|0.001|2-Sided|95.0|0.081|0.141|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)|||
1630221|NCT02119286|2994526|Superiority or Other||Least squared mean difference|0.122|||<|0.001|2-Sided|95.0|0.091|0.152|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)|||
1630222|NCT02119026|2994559|Superiority|||||||0.371||||||The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.|Wilcoxon (Mann-Whitney)||||
1630223|NCT02119026|2994560|Superiority|||||||0.792||||||The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Analysis corresponds to numbers of CR and PR.|Wilcoxon (Mann-Whitney)||||
1630224|NCT02119026|2994561|Superiority|||||||0.618|||||||Mantel Haenszel||||
1630225|NCT02119026|2994562|Superiority|||||||0.668|||||||Mantel Haenszel||||
1630226|NCT02119026|2994563|Superiority|||||||0.728|||||||Mantel Haenszel||||
1630227|NCT02119026|2994564|Superiority|||||||0.854|||||||Fisher Exact||||
1630228|NCT02119026|2994565|Superiority|||||||0.464|||||||Mantel Haenszel||||
1630229|NCT02119026|2994566|Superiority|||||||0.474|||||||Mantel Haenszel||||
1630230|NCT02119026|2994567|Superiority|||||||0.967|||||||Mantel Haenszel||||
1630231|NCT02118896|2994577|Superiority or Other||Kaplan-Meier Method|0.9773|||||2-Sided|95.0|0.933|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.|
1630232|NCT02118896|2994577|Superiority or Other||Kaplan-Meier Method|0.9898|||||2-Sided|95.0|0.97|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.|
1630233|NCT02118896|2994577|Superiority or Other||Kaplan-Meier Method|1.0|||||2-Sided|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.|
1630234|NCT02118896|2994577|Superiority or Other||Kaplan-Meier Method|0.9419|||||2-Sided|95.0|0.883|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.|
1630235|NCT02118896|2994577|Superiority or Other||Kaplan-Meier Method|0.8373|||||2-Sided|95.0|0.693|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.|
1630236|NCT02118896|2994577|Superiority or Other||Kaplan-Meier Method|0.7769|||||2-Sided|95.0|0.675|0.878||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.|
1630237|NCT02118896|2994577|Superiority or Other||Kaplan-Meier Method|0.8816|||||2-Sided|95.0|0.782|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.|
1630238|NCT02118896|2994577|Superiority or Other||Kaplan-Meier Method|0.8792|||||2-Sided|95.0|0.778|0.981||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula..|
1630239|NCT02118896|2994577|Superiority or Other||Kaplan-Meier Method|0.8391|||||2-Sided|95.0|0.729|0.949||||||The two-sided 95% confidence interval for the estimated rate of freedom from efficacy failure at EOS was calculated using Greenwood's formula.|
1630240|NCT02118896|2994580|Superiority or Other||Kaplan-Meier Method|0.9773|||||2-Sided|95.0|0.933|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.|
1630241|NCT02118896|2994580|Superiority or Other||Kaplan-Meier Method|1.0|||||2-Sided|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.|
1630242|NCT02118896|2994580|Superiority or Other||Kaplan-Meier Method|1.0|||||2-Sided|95.0|1.0|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.|
1630243|NCT02118896|2994580|Superiority or Other||Kaplan-Meier Method|0.9948|||||2-Sided|95.0|0.985|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.|
1630244|NCT02118896|2994580|Superiority or Other||Kaplan-Meier Method|0.9607|||||2-Sided|95.0|0.927|0.995||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.|
1630245|NCT02118896|2994580|Superiority or Other||Kaplan-Meier Method|0.8699|||||2-Sided|95.0|0.79|0.949||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.|
1630247|NCT02118896|2994580|Superiority or Other||Kaplan-Meier Method|0.9321|||||2-Sided|95.0|0.858|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.|
1630248|NCT02118896|2994580|Superiority or Other||Kaplan-Meier Method|0.9257|||||2-Sided|95.0|0.844|1.0||||||The two-sided 95% confidence interval for the estimated rate of freedom from BCAR at EOS was calculated using Greenwood's formula.|
1630249|NCT02118792|2994602|Superiority or Other||||||<|0.001|||||||Regression, Logistic||||
1630250|NCT02118766|2994611|Superiority or Other|||||||0.038|||||||Regression, Logistic||||
1630251|NCT02118714|2994621|Other||Percentage of Participants|11.8|||||2-Sided|95.0|1.5|36.4|||||||
1630252|NCT02118714|2994621|Other||Percentage of Participants|11.8|||||2-Sided|80.0|3.2|28.4|||||||
1630253|NCT02118714|2994622|Other||Percentage of Participants|23.5|||||2-Sided|95.0|6.8|49.9|||||||
1630254|NCT02118714|2994622|Other||Percentage of Participants|23.5|||||2-Sided|80.0|10.7|41.6|||||||
1630255|NCT02117999|2994661|Non-Inferiority|sample size calculation was performed to detect a difference of 0.95 D between the average Kmax changes for the T-ionto CL and standard CL groups at 12 months, at a significance level of 5% and a power of 81%, assuming a standard deviation of 1.20 D. The sample size of the study was 34 cases (allocation ratio of 2:1)|Mean Difference (Final Values)|35.0||||0.05|2-Sided||||||ANOVA|||Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values.|
1630256|NCT02117999|2994662|Non-Inferiority|Sample size calculation was performed to detect a difference of 0.95 D between the average Kmax changes for the T-ionto CL and standard CL groups at 12 months, at a significance level of 5% and a power of 81%, assuming a standard deviation of 1.20 D.|||||<|0.05|||||||ANOVA|||Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values. The relationship between the change in Kmax at 12 months and baseline parameters was assessed using Pearson’s correlation analysis for either group.|
1630257|NCT02117479|2994703|Other||Hazard Ratio (HR)|1.056|||||2-Sided|95.0|0.827|1.348|||||||
1630258|NCT02117479|2994704|Other||Hazard Ratio (HR)|0.969|||||2-Sided|95.0|0.747|1.256|||||||
1630259|NCT02117414|2994708|Non-Inferiority or Equivalence|The non-inferiority margin is 10%.|Difference in percentages|0.3||||0.005|1-Sided|90.0|-6.2|||A priori threshold for statistical significance was 0.05|Farrington-Manning non-inferiority test|||"The percentage of subjects who do not experience a 50% decrease in atrial sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group – 10% HA: % successes MRI group > % successes Control group – 10%"|
1630260|NCT02117414|2994709|Non-Inferiority or Equivalence|The non-inferiority margin is 10%.|Difference in percentages|-1.3||||0.006|1-Sided|90.0|-7.0||||Farrington-Manning non-inferiority test|||"The percentage of subjects who experience an APCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group – 10% HA: % successes MRI group > % successes Control group – 10%"|
1630261|NCT02117414|2994710|Non-Inferiority or Equivalence|The non-inferiority margin is 10%|Difference in percentages|0.0|||||2-Sided|||||||||"The percentage of subjects who have a SVC defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group – 10% HA: % successes MRI group > % successes Control group – 10% Where % successes means the % of subjects whose SVC defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms."|
1630262|NCT02117414|2994711|Non-Inferiority or Equivalence|The non-inferiority margin is 10%.|Difference in percentages|1.2|||<|1e-05|1-Sided|90.0|-3.1|||A priori threshold for statistical significance was 0.05.|Farrington-Manning non-inferiority test|||"The percentage of subjects who have a defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group – 10% HA: % successes MRI group > % successes Control group – 10% Where % successes means the % of subjects whose defibrillation impedance at the one month post-MRI/waiting period visit is between 20 and 100 ohms."|
1630263|NCT02117414|2994712|Non-Inferiority or Equivalence|The null hypothesis will be rejected if the one-sided 95% log-log transformed lower confidence bound at 120 days post-implant calculated using Kaplan-Meier (K-M) method is greater than 80%.|Complication-free rate|95.9|||<|0.0001|1-Sided|95.0|93.0|||A priori threshold for statistical significance was 0.05.|Kaplan-Meier method|||"The system-related complication-free rate between the implant procedure and the one month post-MRI/waiting period is greater than 80%.~H0: p ≤ 0.80 HA: p > 0.80 where p is the system-related complication-free rate between the implant procedure and 120 days (the approximate time of the one month post-MRI/waiting period visit)."|
1630264|NCT02117414|2994713|Non-Inferiority or Equivalence|The non-inferiority margin is 8%.|Difference in percentages|0.6||||0.0001|1-Sided|95.0|-4.1|||A priori threshold for statistical significance was 0.025.|Farrington-Manning non-inferiority test|||"The percentage of subjects who do not experience a significant decrease in ventricular sensing amplitude from the pre-MRI/waiting period to one month post-MRI/waiting period is greater than that in the Control group minus 8%.~H0: % successes MRI group ≤ % successes Control group – 8% HA: % successes MRI group > % successes Control group – 8%"|
1630265|NCT02117414|2994714|Non-Inferiority or Equivalence|The non-inferiority margin was 10%.|Difference in percentages|1.2|||<|0.0001|1-Sided|95.0|-3.8|||A priori threshold for statistical significance was 0.025.|Farrington-Manning non-inferiority test|||"The percentage of subjects who experience a VPCT increase less than or equal to 0.5V from the pre-MRI/waiting period to one month post-MRI/waiting period in the MRI group is greater than that in the Control group minus 10%.~H0: % successes MRI group ≤ % successes Control group – 10% HA: % successes MRI group > % successes Control group – 10%"|
1630294|NCT02116621|2994801|Superiority||Adjusted difference in differences|3.31|||||2-Sided|95.0|-1.57|8.19|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
1630266|NCT02117414|2994715|Superiority or Other||Percentage|100.0|||<|0.0001|1-Sided|95.0|97.75|||A priori threshold for statistical significance was 0.025.|one-proportion binomial exact test|||The alternative hypothesis is that the MRI-related event-free rate between the MRI procedure and one month post-MRI is greater than 90%. The null hypothesis will be rejected if the one-sided 97.5% lower confidence bound is greater than 90% or, equivalently, if the p-value is less than 0.025. Assuming type I error rate 0.025, even-free rate under null hypothesis 90% and true even-free rate 0.995, the minimum required sample size is 54 MRI scanned subjects in order to obtain 90% power.|
1630267|NCT02117349|2994718|Other||Odds Ratio (OR)|42.8|||=|0|2-Sided|95.0|4.58|401.0||Study was terminated early at 55 randomized subjects, therefore p-value is considered nominal|Regression, Logistic|||Odds Ratio (OR) and Wald-based 95% Confidence intervals (CIs) are from logistic regression model comparing the response between treatment arms.|
1630268|NCT02117024|2994744|Other||Hazard Ratio (HR)|1.0|||<|0.05|2-Sided||||||Other|||With only 50% of enrollment complete prior to study termination by sponsor, insufficient sample size exists to fully complete efficacy analysis.|
1630269|NCT02117024|2994744|Superiority||||||<|0.0011|||||||Log Rank||||
1630270|NCT02116972|2994757|Superiority||Mean Difference (Final Values)|-0.58||||0.0821|2-Sided|95.0|-1.22|0.07|||Logitudinal mixed effects model|||The step-down testing procedure to control for multiplicity would be voided if the primary endpoint is not met and analyses proceeded for exploratory purposes.|
1630271|NCT02116621|2994778|Superiority||Mean Difference (Final Values)|9.41||||0.054|2-Sided|95.0|-0.15|18.96|||Regression, Linear||||
1630272|NCT02116621|2994779|Superiority||Adjusted difference in differences|1.11|||||2-Sided|95.0|-5.27|7.48|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.||
1630273|NCT02116621|2994780|Superiority||Adjusted difference in differences|1.0|||||2-Sided|95.0|-4.11|6.11|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.||
1630274|NCT02116621|2994781|Superiority||Adjusted difference in differences|4.13|||||2-Sided|95.0|-6.81|15.07|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.||
1630275|NCT02116621|2994782|Superiority||Adjusted difference in differences|1.53|||||2-Sided|95.0|-2.7|5.77|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.||
1630276|NCT02116621|2994783|Superiority||Adjusted difference in differences|-1.91|||||2-Sided|95.0|-9.07|5.26|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.||
1630277|NCT02116621|2994784|Superiority||Adjusted difference in differences|0.08|||||2-Sided|95.0|-3.61|3.77|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.||
1630278|NCT02116621|2994785|Superiority||Adjusted difference in differences|0.76|||||2-Sided|95.0|-1.19|2.7|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.||
1630279|NCT02116621|2994786|Superiority||Adjusted difference in differences|-0.26|||||2-Sided|95.0|-1.61|1.09|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.||
1630280|NCT02116621|2994787|Superiority||Adjusted difference in differences|-1.24|||||2-Sided|95.0|-2.77|0.3|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.||
1630281|NCT02116621|2994788|Superiority||Adjusted difference in differences|0.16|||||2-Sided|95.0|-1.47|1.79|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 52 weeks.||
1630282|NCT02116621|2994789|Superiority||Adjusted difference in differences|1.81|||||2-Sided|95.0|-4.41|8.02|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.||
1630283|NCT02116621|2994790|Superiority||Adjusted difference in differences|2.15|||||2-Sided|95.0|-2.84|7.13|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.||
1630284|NCT02116621|2994791|Superiority||Adjusted difference in differences|7.77|||||2-Sided|95.0|-2.87|18.42|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.||
1630285|NCT02116621|2994792|Superiority||Adjusted difference in differences|1.76|||||2-Sided|95.0|-2.37|5.89|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.||
1630286|NCT02116621|2994793|Superiority||Adjusted difference in differences|4.24|||||2-Sided|95.0|-2.73|11.2|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.||
1630287|NCT02116621|2994794|Superiority||Adjusted difference in differences|1.05|||||2-Sided|95.0|-2.54|4.64|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.||
1630288|NCT02116621|2994795|Superiority||Adjusted difference in differences|-0.66|||||2-Sided|95.0|-2.55|1.24|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.||
1630289|NCT02116621|2994796|Superiority||Adjusted difference in differences|0.3|||||2-Sided|95.0|-1.01|1.61|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.||
1630290|NCT02116621|2994797|Superiority||Adjusted difference in differences|0.31|||||2-Sided|95.0|-1.18|1.81|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.||
1630291|NCT02116621|2994798|Superiority||Adjusted difference in differences|-0.79|||||2-Sided|95.0|-2.37|0.8|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 13 weeks.||
1630292|NCT02116621|2994799|Superiority||Mean Difference (Final Values)|11.9||||0.01|2-Sided|95.0|2.59|21.24|||Regression, Linear||||
1630293|NCT02116621|2994800|Superiority||Adjusted difference in differences|-1.57|||||2-Sided|95.0|-7.68|4.54|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
1630295|NCT02116621|2994802|Superiority||Adjusted difference in differences|7.29|||||2-Sided|95.0|-3.16|17.75|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
1630296|NCT02116621|2994803|Superiority||Adjusted difference in differences|2.55|||||2-Sided|95.0|-1.5|6.6|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
1630297|NCT02116621|2994804|Superiority||Adjusted difference in differences|4.64|||||2-Sided|95.0|-2.25|11.54|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
1630298|NCT02116621|2994805|Superiority||Adjusted difference in differences|1.9|||||2-Sided|95.0|-1.66|5.47|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
1630299|NCT02116621|2994806|Superiority||Adjusted difference in differences|-0.17|||||2-Sided|95.0|-1.45|1.12|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
1630300|NCT02116621|2994807|Superiority||Adjusted difference in differences|0.93|||||2-Sided|95.0|-0.92|2.79|||||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.
1630301|NCT02116621|2994808|Superiority||Adjusted difference in differences|-1.41|||||2-Sided|95.0|-2.87|0.06|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.||
1630302|NCT02116621|2994809|Superiority|||||||0.73|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.81 (-4.41 to 8.02); baseline to 26 weeks: -1.57 (-7.68 to 4.54); baseline to 52 weeks: 1.11 (-5.27 to 7.48).
1630303|NCT02116621|2994810|Superiority|||||||0.58|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 2.15 (-2.84 to 7.13); baseline to 26 weeks: 3.31 (-1.57 to 8.19); baseline to 52 weeks: 1.00 (-4.11 to 6.11).
1630304|NCT02116621|2994811|Superiority|||||||0.44|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 7.77 (-2.87 to 18.42); baseline to 26 weeks: 7.29 (-3.16 to 17.75); baseline to 52 weeks: 4.13 (-6.81 to 15.07).
1630305|NCT02116621|2994812|Superiority|||||||0.66|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.76 (-2.37 to 5.89); baseline to 26 weeks: 2.55 (-1.50 to 6.60); baseline to 52 weeks: 1.53 (-2.70 to 5.77).
1630306|NCT02116621|2994813|Superiority|||||||0.2|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 4.24 (-2.73 to 11.20); baseline to 26 weeks: 4.64 (-2.25 to 11.54); baseline to 52 weeks: -1.91 (-9.07 to 5.26).
1630307|NCT02116621|2994814|Superiority|||||||0.7|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 1.05 (-2.54 to 4.64); baseline to 26 weeks: 1.90 (-1.66 to 5.47); baseline to 52 weeks: 0.08 (-3.61 to 3.77).
1630308|NCT02116621|2994815|Superiority|||||||0.86|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.30 (-1.01 to 1.61); baseline to 26 weeks: -0.17 (-1.45 to 1.12); baseline to 52 weeks: -0.26 (-1.61 to 1.09)
1630309|NCT02116621|2994816|Superiority|||||||0.35|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks:-0.66 (-2.55 to 1.24); baseline to 26 weeks: 0.93 (-0.92 to 2.79); baseline to 52 weeks: 0.76 (-1.19 to 2.70)
1630310|NCT02116621|2994817|Superiority|||||||0.06|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: 0.31 (-1.18 to 1.81); baseline to 26 weeks: -1.41 (-2.87 to 0.06); baseline to 52 weeks: -1.24 (-2.77 to 0.30)
1630311|NCT02116621|2994818|Superiority|||||||0.21|||||||Mixed Models Analysis||||Longitudinal analysis adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control). Baseline to 13 weeks: -0.79 (-2.37 to 0.80); baseline to 26 weeks: -1.36 (-2.91 to 0.19); baseline to 52 weeks: 0.16 (-1.47 to 1.79)
1630312|NCT02116621|2994819|Superiority||Adjusted difference in differences|-1.36|||||2-Sided|95.0|-2.91|0.19|||||Adjusted difference in differences using mixed effects Gaussian model (Trialist intervention - control) from baseline to 26 weeks.||
1630313|NCT02115581|2994878|Superiority or Other|||||||0.011|||||||Fisher Exact||||
1630314|NCT02115581|2994879|Superiority or Other|||||||0.267|||||||Wilcoxon (Mann-Whitney)||||
1630315|NCT02115373|2994911|Other||Median|5.55|||||2-Sided|90.0|5.092|8.181|||||Overall Survival time in months was calculated for Phase 2: Tepotinib 500 mg.||
1630316|NCT02115373|2994911|Other||Median|7.2|||||2-Sided|90.0|3.68|10.119|||||Overall Survival time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.||
1630317|NCT02115373|2994913|Other||Median|3.35|||||2-Sided|90.0|2.76|4.172|||||PFS time in months was was calculated for Phase 2: Tepotinib 500 mg.||
1630318|NCT02115373|2994913|Other||Median|1.48|||||2-Sided|90.0|1.413|3.844|||||PFS time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.||
1630319|NCT02115373|2994914|Other||Median|3.22|||||2-Sided|90.0|0.03|16.53|||||PFS time in months was calculated for Phase 2: Tepotinib 500 mg.||
1630320|NCT02115373|2994914|Other||Median|1.51|||||2-Sided|90.0|1.413|3.68|||||PFS time in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.||
1630321|NCT02115373|2994915|Other||Median|3.98|||||2-Sided|90.0|2.858|4.238|||||TTP in months was calculated for Phase 2: Tepotinib 500 mg.||
1630322|NCT02115373|2994915|Other||Median|2.07|||||2-Sided|90.0|1.446|7.195|||||TTP in months was calculated for Phase 1b: Tepotinib 300 mg and Phase 1b: Tepotinib 500 mg combined.||
1630372|NCT02115308|2994937|Superiority|||||||0.602|||||||t-test, 2 sided|non adjusted||REST|
1630323|NCT02115347|2994919|Superiority or Other||Ratio (Test/Reference) of Adjusted Means|86.52|||||2-Sided|90.0|70.49|106.2|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals [CIs]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).||
1630324|NCT02115347|2994920|Superiority or Other||Ratio (Test/Reference) of Adjusted Means|78.7|||||2-Sided|90.0|65.74|94.23|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals [CIs]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).||
1630325|NCT02115347|2994921|Superiority or Other||Ratio (Test/Reference) of Adjusted Means|95.92|||||2-Sided|90.0|72.46|126.97|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals [CIs]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).||
1630326|NCT02115347|2994922|Superiority or Other||Ratio (Test/Reference) of Adjusted Means|95.81|||||2-Sided|90.0|72.4|126.79|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals [CIs]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).||
1630327|NCT02115347|2994923|Superiority or Other||Ratio (Test/Reference) of Adjusted Means|87.43|||||2-Sided|90.0|68.11|112.22|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals [CIs]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).||
1630328|NCT02115347|2994924|Superiority or Other||Ratio (Test/Reference) of Adjusted Means|87.31|||||2-Sided|90.0|68.01|112.08|||||ANOVA model with hepatic function group as a fixed effect, ratios (and 90% confidence intervals [CIs]) were expressed as percentages, Moderate Hepatic Impairment (Test), Normal Hepatic Function (Reference).||
1630329|NCT02115308|2994933|Superiority|||||||0.957|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change|
1630330|NCT02115308|2994933|Superiority|||||||0.172|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change|
1630331|NCT02115308|2994933|Superiority||||||<|0|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change|
1630332|NCT02115308|2994933|Superiority||||||<|0.004|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS|
1630333|NCT02115308|2994933|Superiority||||||<|0|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS|
1630334|NCT02115308|2994933|Superiority||||||<|0.002|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS|
1630335|NCT02115308|2994933|Superiority||||||<|0.006|||||||t-test, 2 sided|non adjusted||REST|
1630336|NCT02115308|2994933|Superiority||||||<|0|||||||t-test, 2 sided|non adjusted||REST|
1630337|NCT02115308|2994933|Superiority||||||<|0|||||||t-test, 2 sided|non adjusted||REST|
1630338|NCT02115308|2994933|Superiority||||||<|0.428|||||||paired, t-test|non adjusted||REST vs STRESS|
1630339|NCT02115308|2994933|Superiority||||||<|0.006|||||||paired, t-test|non adjusted||REST vs STRESS|
1630340|NCT02115308|2994933|Superiority||||||<|0.008|||||||paired, t-test|non adjusted||REST vs STRESS|
1630341|NCT02115308|2994935|Superiority|||||||0.187|||||||t-test, 2 sided|non adjusted||REST-to-STRESS Change|
1630342|NCT02115308|2994935|Superiority|||||||0.233|||||||t-test, 2 sided|non adjusted|||
1630343|NCT02115308|2994935|Superiority|||||||0.908||||||non adjusted|t-test, 2 sided|||REST-to-STRESS Change|
1630344|NCT02115308|2994935|Superiority|||||||0.05|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS|
1630345|NCT02115308|2994935|Superiority|||||||0.041|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS|
1630346|NCT02115308|2994935|Superiority|||||||0.717|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS|
1630347|NCT02115308|2994935|Superiority|||||||0.537|||||||t-test, 2 sided|non adjusted|||
1630348|NCT02115308|2994935|Superiority|||||||0.474|||||||t-test, 2 sided|non adjusted||REST|
1630349|NCT02115308|2994935|Superiority|||||||0.797|||||||t-test, 2 sided|non adjusted||REST|
1630350|NCT02115308|2994935|Superiority|||||||0.721|||||||paired, t-test|non adjusted||REST vs STRESS|
1630351|NCT02115308|2994935|Superiority|||||||0.002|||||||paired, t-test|non adjusted||REST vs STRESS|
1630352|NCT02115308|2994935|Superiority|||||||0.001|||||||paired, t-test|non adjusted||REST vs STRESS|
1630353|NCT02115308|2994936|Superiority|||||||0.31|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Change|
1630354|NCT02115308|2994936|Superiority|||||||0.058|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Changes|
1630355|NCT02115308|2994936|Superiority||||||<|0|||||||t-test, 2 sided|non-adjusted||REST-TO-STRESS Change|
1630356|NCT02115308|2994936|Superiority||||||<|0.006||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS|
1630357|NCT02115308|2994936|Superiority||||||<|0||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS|
1630358|NCT02115308|2994936|Superiority||||||<|0.001||||||non-adjusted|t-test, 2 sided|||Regadenoson STRESS|
1630359|NCT02115308|2994936|Superiority|non-adjusted|||||<|0.022|||||||t-test, 2 sided|||REST|
1630360|NCT02115308|2994936|Superiority|non-adjusted|||||<|0|||||||t-test, 2 sided|||REST|
1630361|NCT02115308|2994936|Superiority|non-adjusted|||||<|0|||||||t-test, 2 sided|||REST|
1630362|NCT02115308|2994936|Superiority|non-adjusted|||||<|0.39|||||||paired, t-test|||Rest VS Regadenoson Stress|
1630363|NCT02115308|2994936|Superiority||||||<|0.003||||||non-adjusted|paired t-test|||Rest VS Regadenoson Stress|
1630364|NCT02115308|2994936|Superiority||||||<|0.011||||||Non-adjusted.|paired, t-test|||Rest VS Regadenoson Stress|
1630365|NCT02115308|2994937|Superiority|||||||0.048|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS Change|
1630366|NCT02115308|2994937|Superiority|||||||0.03|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS Change|
1630367|NCT02115308|2994937|Superiority|||||||0.399|||||||t-test, 2 sided|non adjusted||REST-TO-STRESS CHANGE|
1630368|NCT02115308|2994937|Superiority|||||||0.087|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS|
1630369|NCT02115308|2994937|Superiority|||||||0.002|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS|
1630370|NCT02115308|2994937|Superiority|||||||0.033|||||||t-test, 2 sided|non adjusted||Regadenoson STRESS|
1630371|NCT02115308|2994937|Superiority|||||||0.915|||||||t-test, 2 sided|non adjusted||REST|
1630382|NCT02114892|2994965|Superiority or Other (legacy)|||||||0.365|||||||Wilcoxon (Mann-Whitney)||||
1630383|NCT02114892|2994966|Superiority or Other (legacy)|||||||0.946|||||||Wilcoxon (Mann-Whitney)||||
1630384|NCT02114892|2994967|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1630385|NCT02114892|2994968|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1630386|NCT02114892|2994969|Superiority or Other (legacy)|||||||0.083|||||||Wilcoxon (Mann-Whitney)||||
1630387|NCT02114892|2994970|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1630388|NCT02114892|2994971|Superiority or Other (legacy)|||||||0.278|||||||Wilcoxon (Mann-Whitney)||||
1630389|NCT02114892|2994972|Superiority or Other (legacy)|||||||0.338|||||||Wilcoxon (Mann-Whitney)||||
1630390|NCT02114892|2994973|Superiority or Other (legacy)|||||||0.07|||||||Wilcoxon (Mann-Whitney)||||
1630391|NCT02114892|2994974|Superiority or Other (legacy)|||||||0.859|||||||Wilcoxon (Mann-Whitney)||||
1630392|NCT02114892|2994975|Superiority or Other (legacy)|||||||0.131|||||||Wilcoxon (Mann-Whitney)||||
1630393|NCT02114684|2994977|Superiority|||||||0.15|||||||Fisher Exact||||
1630394|NCT02114684|2994978|Superiority|||||||0.45|||||||Mantel Haenszel|||Comparison of the 8-week culture conversion rates in the two arms, controlling for HIV status|
1630395|NCT02114684|2994978|Superiority|||||||0.01||||||There are significantly more adverse events in the active arm|Mantel Haenszel|||Comparison of the number of adverse events in the two arms, controlling for HIV status|
1630396|NCT02114684|2994979|Superiority|||||||0.011|||||||Fisher Exact||||
1630397|NCT02114684|2994980|Superiority|||||||0.018|||||||Gehan-Breslow-Wilcoxon test||||
1630398|NCT02114684|2994981|Superiority|||||||0.43|||||||Fisher Exact|||comparison of culture negative results at month 6|
1630399|NCT02114684|2994981|Superiority|||||||0.46|||||||Fisher Exact|||comparison of culture negative results at week 8|
1630400|NCT02114385|2995010|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was >0.50|GMT Ratio|1.12|||<|0.001|2-Sided|95.0|0.91|1.37|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 18|
1630401|NCT02114385|2995010|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was >0.50|GMT Ratio|1.04|||<|0.001|2-Sided|95.0|0.89|1.21|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 16|
1630402|NCT02114385|2995010|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was >0.50|GMT Ratio|0.89|||<|0.001|2-Sided|95.0|0.76|1.04|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 11|
1630403|NCT02114385|2995010|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was >0.50|GMT Ratio|1.23|||<|0.001|2-Sided|95.0|1.04|1.45|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 6|
1630404|NCT02114307|2995011|Superiority|||||||0.127|||||||t-test, 1 sided||||
1630405|NCT02114307|2995012|Superiority|||||||0.0815|||||||t-test, 2 sided|||Test Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation|
1630406|NCT02114307|2995012|Superiority|||||||0.0023|||||||t-test, 2 sided|||Sham Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation|
1630407|NCT02114307|2995013|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1630408|NCT02113956|2995056|Superiority||Odds Ratio (OR)|3.39|||||2-Sided|95.0|1.52|7.58|||||||Adjusted for age and baseline rate of HIV testing
1630409|NCT02113956|2995057|Superiority||Odds Ratio (OR)|3.4|||||2-Sided|95.0|0.88|16.95|||||||Adjusted for age and baseline rate of abstinence
1630410|NCT02113956|2995058|Superiority||Odds Ratio (OR)|0.93|||||2-Sided|95.0|0.46|1.88|||||||Adjusted for age and baseline rate of abstinence
1630411|NCT02113956|2995059|Superiority||Incident Rate Ratio (IRR)|1.1|||||2-Sided|95.0|0.01|92.03|||||||Adjusted for age and baseline number of condomless sex acts
1630412|NCT02113956|2995060|Superiority||Incident Rate Ratio (IRR)|0.6|||||2-Sided|95.0|0.22|1.68|||||||Adjusted for age and baseline number of condomless sex acts
1630413|NCT02113956|2995061|Superiority||Odds Ratio (OR)|1.12|||||2-Sided|95.0|0.6|2.09|||||||Adjusted for age and baseline rate of abstinence
1630414|NCT02113956|2995062|Superiority||Incident Risk Ratio (IRR)|0.58|||||2-Sided|95.0|0.22|1.5|||||||Adjusted for age and baseline number of condomless sex acts
1630415|NCT02113956|2995063|Superiority||Odds Ratio (OR)|3.42|||||2-Sided|95.0|1.65|7.09|||||||Adjusted for age and baseline rate of HIV testing
1630416|NCT02113956|2995064|Superiority||Odds Ratio (OR)|0.98|||||2-Sided|95.0|0.38|2.53|||||||Adjusted for age and baseline rate of abstinence
1630417|NCT02113956|2995065|Superiority||Odds Ratio (OR)|0.48|||||2-Sided|95.0|0.23|0.997|||||||Adjusted for age and baseline rate of abstinence
1630418|NCT02113956|2995066|Superiority||Incident Rate Ratio (IRR)|0.62|||||2-Sided|95.0|0.12|3.18|||||||Adjusted for age and baseline number of condomless sex acts
1630419|NCT02113956|2995067|Superiority||Incident Rate Ratio|0.95|||||2-Sided|95.0|0.45|2.02|||||||Adjusted for age and baseline number of condomless sex acts
1630420|NCT02113956|2995068|Superiority||Odds Ratio (OR)|0.63|||||2-Sided|95.0|0.36|1.12|||||||Adjusted for age and baseline rate of abstinence
1630421|NCT02113956|2995069|Superiority||Incident Rate Ratio (IRR)|1.42|||||2-Sided|95.0|0.79|2.57|||||Adjusted for age and baseline number of condomless sex acts||
1630422|NCT02113579|2995070|Superiority or Other||Least Squares Mean Difference|-7.61|Standard Error of the Mean|1.873|<|0.001|2-Sided|95.0|-11.29|-3.93||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups|
1630434|NCT02113436|2995094|Superiority or Other||Difference in Least-Square Means|0.7||||0.041|2-Sided|95.0|0.0|1.4|||ANCOVA||||
1630435|NCT02113436|2995095|Superiority or Other||Odds Ratio (OR)|0.47|||||2-Sided|95.0|0.14|1.6|||||||
1630423|NCT02113579|2995071|Superiority or Other||Least Squares Mean Difference|-3.24|Standard Error of the Mean|1.422||0.023|2-Sided|95.0|-6.04|-0.45||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1630424|NCT02113579|2995072|Superiority or Other||Least Squares Mean Difference|-11.52|Standard Error of the Mean|1.92|<|0.001|2-Sided|95.0|-15.3|-7.75||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1630425|NCT02113579|2995073|Superiority or Other||Least Squares Mean Difference|-6.67|Standard Error of the Mean|1.65|<|0.001|2-Sided|95.0|-9.92|-3.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1630426|NCT02113579|2995074|Superiority or Other||Success rate difference (%)|15.44||||0.002|2-Sided|||||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|Regression, Logistic|Study center and mean baseline cold air stimulus VAS score as covariate. For subjects with no score at Week 2, non-response was imputed.|Estimated by calculating the model predicted success probabilities assuming all subjects received 12027-033 and then assuming all subjects received placebo, and then calculating mean of subjects' differences between these predicted probabilities.|The null hypothesis was no difference in success rates between treatment groups. The alternative hypothesis was a difference in success rates between treatment groups.|
1630427|NCT02113579|2995075|Superiority or Other||Least Squares Mean Difference|4.7|Standard Error of the Mean|0.975|<|0.001|2-Sided|95.0|2.78|6.62||Per statistical analysis plan, Hochberg’s method at significance level 0.05 was applied to jointly evaluate secondary outcomes Mean Cold Air Stimulus VAS Score at Wk 2 and Mean Tactile Sensitivity Score at Wk 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1630428|NCT02113579|2995076|Superiority or Other||Least Squares Mean Difference|-7.67|Standard Error of the Mean|1.809|<|0.001|2-Sided|95.0|-11.23|-4.11||Per statistical analysis plan, Hochberg’s method at significance level 0.05 was applied to jointly evaluate secondary outcomes Mean Cold Air Stimulus VAS Score at Wk 2 and Mean Tactile Sensitivity Score at Wk 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1630429|NCT02113579|2995077|Superiority or Other||Least Squares Mean Difference|13.45|Standard Error of the Mean|1.844|<|0.001|2-Sided|95.0|9.83|17.08||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p<0.05), testing proceeded to Mean Cold Air Stimulus VAS Score at Week 2 and Mean Tactile Sensitivity Score at Week 2. Family-wise error controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1630430|NCT02113579|2995078|Superiority or Other||Least Squares Mean Difference|-14.27|Standard Error of the Mean|2.239|<|0.001|2-Sided|95.0|-18.68|-9.87||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p<0.05), testing proceeded to Mean Tactile Sensitivity Score at Week 4. Family-wise error was controlled at 0.05.|Repeated Measures Model|Analysis included Weeks 2 and 4 data. Terms included treatment, visit, study center, baseline value, treatment-by-visit and baseline-by-visit.|For subjects without post-baseline data, the baseline value was carried forward to Week 2. An unstructured covariance pattern was assumed.|The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1630431|NCT02113579|2995079|Superiority or Other||Success rate difference (%)|24.7|||<|0.001|2-Sided|||||Per statistical analysis plan, if experimental rinse was significantly better than placebo (p<0.05) with estimated difference of >= 20%, testing proceeded to Mean Cold Air Stimulus VAS Score at Week 4. Family-wise error was controlled at 0.05.|Regression, Logistic|Study center and mean baseline cold air stimulus VAS score as covariate. For subjects with no score at Week 4, non-response was imputed.|Estimated by calculating the model predicted success probabilities assuming all subjects received 12027-033 and then assuming all subjects received placebo, and then calculating mean of subjects' differences between these predicted probabilities.|The null hypothesis was no difference in success rates between treatment groups. The alternative hypothesis was a difference in success rates between treatment groups.|
1630432|NCT02113436|2995092|Superiority or Other||Difference in Least Square Means|2.6||||0.389|2-Sided|95.0|-3.3|8.6|||ANCOVA||||
1630433|NCT02113436|2995093|Superiority or Other||Difference in Least Square Means|-0.06||||0.335|2-Sided|95.0|-0.2|0.07|||ANCOVA||||
1630436|NCT02113436|2995096|Superiority or Other||Difference in Least-Sqaure means|-0.48||||0.236|2-Sided|95.0|-1.27|0.31|||ANCOVA||||
1630437|NCT02113436|2995097|Superiority or Other||Difference in Least sqaure means|-0.49||||0.235|2-Sided|95.0|-1.29|0.32|||ANCOVA||||
1630438|NCT02113436|2995098|Superiority or Other||Difference in Least square means|-0.97||||0.206|2-Sided|95.0|-2.47|0.54|||ANCOVA||||
1630439|NCT02112838|2995145|Superiority||Mean Difference (Final Values)|-399.7||||0.4|2-Sided|95.0|-1320.8|521.3|||ANCOVA||||
1630440|NCT02112838|2995145|Superiority||Mean Difference (Final Values)|19.9||||0.97|2-Sided|95.0|-910.6|950.5|||ANCOVA||||
1630441|NCT02112370|2995155|Superiority or Other|||||||0.634||||||threshold p value for significance < 0.05|t-test, 2 sided|||Posterior neck pain|
1630442|NCT02112370|2995155|Superiority or Other|||||||0.089||||||threshold p value for significance < 0.05|t-test, 2 sided|||Back pain|
1630443|NCT02112370|2995155|Superiority or Other|||||||0.035||||||threshold p value for significance < 0.05|t-test, 2 sided|||Left chest pain|
1630444|NCT02112370|2995155|Superiority or Other|||||||0.019||||||threshold p value for significance < 0.05|t-test, 2 sided|||Right chest pain|
1630445|NCT02112370|2995155|Superiority or Other|||||||0.016||||||threshold p value for significance < 0.05|t-test, 2 sided|||Anterior neck pain|
1630446|NCT02112370|2995155|Superiority or Other|||||||0.008||||||threshold p value for significance < 0.05|t-test, 2 sided|||Swallowing difficulty|
1630447|NCT02112045|2995158|Superiority|||||||0.6|||||||Log Rank||||
1630448|NCT02112045|2995159|Superiority|||||||0.43|||||||Log Rank||||
1630449|NCT02111993|2995163|Superiority or Other|||||||0.38||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided||||
1630450|NCT02111993|2995163|Superiority or Other|||||||0.19||||||This p-value correlates to Δ8 hr cTnT|t-test, 2 sided||||
1630451|NCT02111993|2995163|Superiority or Other|||||||0.17||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided||||
1630452|NCT02111993|2995164|Superiority or Other|||||||0.16||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided||||
1630453|NCT02111993|2995164|Superiority or Other|||||||0.06||||||This p-value correlates to Δ8 hr cTnT|t-test, 2 sided||||
1630454|NCT02111993|2995164|Superiority or Other|||||||0.04||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided||||
1630455|NCT02111993|2995165|Superiority or Other|||||||0.16||||||This p-value correlates to Δ20 hr cTnT|t-test, 2 sided||||
1630456|NCT02111993|2995165|Superiority or Other|||||||0.03||||||This p-value correlates to Δ8 hr cTnT.|t-test, 2 sided||||
1630457|NCT02111993|2995165|Superiority or Other|||||||0.02||||||This p-value correlates to Δ4 hr cTnT|t-test, 2 sided||||
1630458|NCT02111980|2995175|Superiority or Other (legacy)|||||||1|||||||t-test, 2 sided||||
1630459|NCT02111772|2995188|Superiority||||||<|0.001|||||||Negative binomial regression||||
1630460|NCT02111772|2995189|Superiority|||||||0.049|||||||Negative binomial regression||||
1630461|NCT02111746|2995195|Superiority|||||||0.202|||||||Wilcoxon (Mann-Whitney)||||
1630462|NCT02111746|2995196|Superiority|||||||0.188|||||||Wilcoxon (Mann-Whitney)||||
1630463|NCT02111746|2995197|Superiority|||||||0.774|||||||Wilcoxon (Mann-Whitney)||||
1630464|NCT02111746|2995198|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1630465|NCT02111746|2995199|Superiority|||||||0.449|||||||Wilcoxon (Mann-Whitney)||||
1630466|NCT02111746|2995200|Superiority|||||||0.512|||||||Wilcoxon (Mann-Whitney)||||
1630467|NCT02111746|2995201|Superiority|||||||0.014|||||||Wilcoxon (Mann-Whitney)||||
1630468|NCT02111746|2995202|Superiority|||||||0.036|||||||Wilcoxon (Mann-Whitney)||||
1630469|NCT02111746|2995203|Superiority|||||||0.934|||||||Wilcoxon (Mann-Whitney)||||
1630470|NCT02111603|2995209|Superiority or Other|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||Comparison of on-treatment total fecal bile acid excretion with baseline total fecal bile acid excretion.|
1630471|NCT02111564|2995210|Superiority||Hazard Ratio (HR)|0.8||||0.156|2-Sided|95.0|0.58|1.09|||Cox proportional hazards model||||
1630472|NCT02111564|2995211|Superiority||Hazard Ratio (HR)|0.78||||0.073|2-Sided|95.0|0.6|1.02|||Cox proportional hazards model||||
1630473|NCT02111564|2995212|Superiority||Hazard Ratio (HR)|0.73||||0.033|2-Sided|95.0|0.54|0.97|||Cox proportional hazards model||||
1630474|NCT02111564|2995213|Superiority||Hazard Ratio (HR)|0.44||||0.023|2-Sided|95.0|0.22|0.89|||Cox proportional hazards model||||
1630475|NCT02111564|2995214|Superiority||Hazard Ratio (HR)|0.93||||0.751|2-Sided|95.0|0.62|1.42|||Cox proportional hazards model||||
1630476|NCT02111564|2995215|Superiority||Hazard Ratio (HR)|1.88||||0.124|2-Sided|95.0|0.84|4.23|||Cox proportional hazards model||||
1630477|NCT02111564|2995216|Superiority||Hazard Ratio (HR)|0.76||||0.136|2-Sided|95.0|0.52|1.09|||Cox proportional hazards model||||
1630478|NCT02111083|2995271|Superiority or Other||Ratio of geometric least square means|0.992|||||2-Sided|90.0|0.975|1.01|||||||
1630479|NCT02111083|2995272|Superiority or Other||Difference of least squares means|0.424|||||2-Sided|90.0|0.164|0.685|||||||
1630480|NCT02111083|2995273|Superiority or Other||Ratio of geometric least square means|0.95|||||2-Sided|90.0|0.901|1.0|||||||
1630481|NCT02111083|2995274|Superiority or Other||Ratio of geometric least square means|0.986|||||2-Sided|90.0|0.954|1.02|||||||
1630482|NCT02111083|2995275|Superiority or Other||Median Difference (Final Values)|0.25|||||2-Sided|90.0|0.0|0.375|||||||
1630483|NCT02111083|2995276|Superiority or Other||Ratio of geometric least square means|0.872|||||2-Sided|90.0|0.828|0.919|||||||
1630484|NCT02111083|2995277|Superiority or Other||Ratio of geometric least square means|0.986|||||2-Sided|90.0|0.965|1.01|||||||
1630485|NCT02110901|2995278|Superiority|||||||0.035|||||||Chi-squared||||
1630486|NCT02110901|2995279|Superiority|||||||0.109|||||||Chi-squared||||
1630487|NCT02110901|2995280|Superiority||Hazard Ratio (HR)|0.66||||0.048|2-Sided|95.0|0.43|1.0|||Log Rank||||
1630488|NCT02110901|2995281|Superiority||Hazard Ratio (HR)|0.83||||0.254|2-Sided|95.0|0.61|1.14|||Log Rank||||
1630604|NCT02107014|2995670|Superiority or Other|||||||0.326|||||||Mixed Models Analysis||||
1630489|NCT02110706|2995282|Other||Mean Difference (Final Values)|-1.09||||0.39|1-Sided|90.0||1.03|||Regression, Linear|||This objective was assessed longitudinally by comparing the final score at the end of the study to the score obtained at baseline. The outcome was defined as the change from baseline to week 52 in the QMG. This hypothesis was assessed using a linear regression model, adjusted for differences in baseline QMG scores.|
1630490|NCT02110706|2995283|Other||Mean Difference (Final Values)|-0.11||||0.93|1-Sided|90.0||2.02|||Regression, Linear|||This objective was assessed longitudinally by comparing the final score at the end of the study to the score obtained at baseline. The outcome was defined as the change from baseline to week 52 in the MGC. This hypothesis was assessed using a linear regression model, adjusted for differences in baseline MGC scores.|
1630491|NCT02110706|2995284|Superiority||Odds Ratio (OR)|0.75||||0.65|2-Sided|90.0|0.27|2.11|||t-test, 2 sided|||% study participants with treatment related SAEs|
1630492|NCT02110706|2995284|Superiority||Odds Ratio (OR)|0.72||||0.63|2-Sided|90.0|0.23|2.21|||t-test, 2 sided|||% of study participants with treatment related AEs|
1630493|NCT02110706|2995285|Other|A futility (non-superiority) design is a screening tool to identify whether agents should be candidates for phase III trials while minimizing costs/sample size If “futility” is declared, results would imply not cost effective to conduct a future phase III clinical trial If “futility” is not declared, suggests that there could be a clinically meaningful effect – supports exploration in a larger, phase III trial|Odds Ratio (OR)|1.14||||0.03|1-Sided|90.0||2.41|||Regression, Logistic|||"This futility design tests the following hypothesis:~H0: Rituximab improves outcome by at least 30% compared to placebo (pR – pP ≥ 0.30 – not futile) versus HA: Rituximab does not improve outcome by at least 30% compared to placebo (pR – pP < 0.30 – futile)"|
1630494|NCT02110693|2995286|Other||Spearman Correlation|0.4|||||2-Sided|95.0|0.33|0.46|||||The estimated value is a point estimate of the Spearman Correlation between the TAPS Tool Cannabis Score and the Oral Fluid Cannabis Screen. A Confidence Interval rather than a dispersion value is therefore reported.||
1630495|NCT02110693|2995286|Other|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard of the results of the oral fluid test was assessed using Spearman Correlation.|Spearman Correlation|0.42|||||2-Sided|95.0|0.35|0.48|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Cannabis Score and the results of the Oral Fluid Test. Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.|
1630496|NCT02110693|2995287|Other||Spearman Correlation|0.28|||||2-Sided|95.0|0.24|0.32|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Tobacco Score and the score on the Smokeless Tobacco Questionnaire. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.|
1630497|NCT02110693|2995287|Other|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard Smokeless Tobacco Questionnaire was assessed using Spearman Correlation.|Spearman Correlation|0.29|||||2-Sided|95.0|0.25|0.33|||||The estimated value is a Spearman Correlation point estimate between the TAPS Tool Tobacco Score and the Smokeless Tobacco Questionnare. Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet computer) was tested separately against the reference measure.|
1630498|NCT02110693|2995289|Other|The association on the interviewer and tablet administered versions of the TAPS Tool compared to the reference standard of the AUDIT C score was assessed using Spearman Correlation.|Spearman Correlation|0.64|||||2-Sided|95.0|0.61|0.68|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C Score. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) was tested separately against the reference measure.|
1630499|NCT02110693|2995289|Other|The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard AUDIT-C score was assessed using Spearman Correlation.|Spearman Correlation|0.63|||||2-Sided|95.0|0.59|0.66|||||The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C score. A Confidence Interval rather than a dispersion value is therefore reported.|Each administration approach (interviewer and tablet) were tested separately against the reference measure.|
1630500|NCT02110693|2995293|Other|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.|Sensivity|0.66|||||2-Sided|95.0|0.53|0.77||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.|
1630501|NCT02110693|2995293|Other|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.|sensivity|0.66|||||2-Sided|95.0|0.53|0.77||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.|
1630502|NCT02110693|2995294|Other|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.6|||||2-Sided|95.0|0.5|0.69||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.|
1630503|NCT02110693|2995294|Other|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.57|||||2-Sided|95.0|0.47|0.67||||||Each administration approach (interviewer and tablet) were tested separately against the reference measure.|
1630504|NCT02110693|2995295|Other|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.7|||||2-Sided|95.0|0.62|0.77||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.|
1630546|NCT02109159|2995412|Superiority or Other||Mean Difference (Final Values)|0.01||||0.53|2-Sided|95.0|-0.02|0.04|||t-test, 2 sided||This analysis was conducted on an intention-to-treat (ITT) basis including all participants randomised.||
1630505|NCT02110693|2995295|Other|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.71|||||2-Sided|95.0|0.63|0.79||||||Each administration approach (interviewer and tablet) were separately tested against the reference measure.|
1630506|NCT02110693|2995296|Other|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.74|||||2-Sided|95.0|0.68|0.79||||||Each administration approach (interviewer and tablet) was tested separately against the reference measure.|
1630507|NCT02110693|2995296|Other|Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.|Sensitivity|0.7|||||2-Sided|95.0|0.64|0.75||||||Each administration approach (interviewer and tablet) was tested separately against the reference measure.|
1630508|NCT02110485|2995297|Other|||||||0.99|||||||Wilcoxon (Mann-Whitney)||||
1630509|NCT02110485|2995298|Other|||||||0.84|||||||Fisher Exact||||
1630510|NCT02110485|2995299|Other|||||||0.17|||||||Wilcoxon (Mann-Whitney)||||
1630511|NCT02110485|2995300|Other|||||||0.67|||||||Wilcoxon (Mann-Whitney)||||
1630512|NCT02110485|2995301|Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1630513|NCT02110485|2995302|Superiority|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1630514|NCT02110238|2995310|Non-Inferiority or Equivalence|A VAS (0-100 mm) WOMAC Pain subscale score CFB; an equal n t-test for non-inferiority of means; a non-inferiority margin of -8 mm; change standard deviation of 26 mm; two-sided alpha=0.05; 80% power; an expected mean difference of 0, and a drop-out plus important deviation percentage of approximately 20% were used to establish study sample size.|Least square mean difference|-3.3|||||2-Sided|95.0|-6.77|0.17|||||A MERM regression model was fit to the change from baseline at weeks 3, 6, and 12. The over weeks 3, 6, and 12 “single point estimate” least square mean change was calculated for both arms, the difference and its 95% confidence interval calculated.||
1630515|NCT02109939|2995336|Superiority||Odds Ratio (OR)|1.31||||0.0663|2-Sided|95.0|0.98|1.76|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.|||
1630516|NCT02109939|2995337|Superiority||Odds Ratio (OR)|1.43||||0.014|2-Sided|95.0|1.07|1.89|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.|||
1630517|NCT02109939|2995346|Superiority||Odds Ratio (OR)|1.43||||0.0023|2-Sided|95.0|1.14|1.79|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.|||
1630518|NCT02109939|2995347|Superiority||Odds Ratio (OR)|1.13||||0.2852|2-Sided|95.0|0.9|1.43|||Generalized linear mixed model.|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.|||
1630519|NCT02109939|2995350|Superiority||Odds Ratio (OR)|1.61||||0.0066|2-Sided|95.0|1.14|2.27|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.|||
1630520|NCT02109939|2995353|Superiority||Odds Ratio (OR)|1.41||||0.0134|2-Sided|95.0|1.07|1.86|||Generalized linear mixed model|The reported outcome measure is the estimated percentage from a generalized linear mixed model, not a simple count of subjects.|||
1630521|NCT02109939|2995354|Superiority||Mean Difference (Net)|-2.207|Standard Error of the Mean|1.653||0.1822|2-Sided|95.0|-5.45|1.036|||Mixed Models Analysis|MMRM with week 4 data.|||
1630522|NCT02109939|2995355|Superiority||Mean Difference (Net)|-2.836|Standard Error of the Mean|1.758||0.107|2-Sided|95.0|-6.285|0.613|||Mixed Models Analysis|Repeated Measures including week 4.|||
1630523|NCT02109640|2995360|Superiority or Other|||||||0.676|||||||t-test, 2 sided||||
1630524|NCT02109640|2995361|Superiority or Other|||||||0.222|||||||t-test, 2 sided||||
1630525|NCT02109640|2995362|Superiority or Other||Absolute percentage difference|17.1||||0.264|2-Sided|95.0|-10.0|40.7||Absolute % difference 17.1 (95% CI -10.0,40.7)|Fisher Exact||||
1630526|NCT02109562|2995364|Superiority||Mean Difference (Final Values)|-0.396|Standard Error of the Mean|0.0928|<|0.0001|2-Sided|95.0|-0.602|-0.19||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at <0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 120 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.|
1630527|NCT02109562|2995364|Superiority||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.0934|<|0.0002|2-Sided|95.0|-0.557|-0.143||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at <0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 90 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.|
1630528|NCT02109562|2995365|Superiority||Mean Difference (Final Values)|-7.237|Standard Error of the Mean|1.7141|<|0.0001|2-Sided|95.0|-11.045|-3.429||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at <0.025. The P values have been adjusted for multiple comparisons using Dunnett's procedure.|repeated measure linear regression model||RBP-7000 120 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.|
1630547|NCT02109159|2995413|Superiority or Other||Risk Ratio (RR)|1.2||||0.47|2-Sided|95.0|0.8|1.7|||Chi-squared||This analysis was conducted on a per-protocol (PP) basis including only those who watched the videos.||
1630529|NCT02109562|2995365|Superiority||Mean Difference (Final Values)|-6.148|Standard Error of the Mean|1.7261|<|0.0004|2-Sided|95.0|-9.982|-2.314||For evaluation of treatment differences, compare against a 1-sided adjusted P value with significance at <0.025. The P values have been adjusted for multiple comparisons using Dunnett’s procedure.|repeated measure linear regression model||RBP-7000 90 mg - Placebo|Estimates, standard errors (SE), 2-sided confidence intervals (CIs), and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix.|
1630530|NCT02109484|2995369|Equivalence|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide >= 89% and >= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide > 95% to detect >= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||A pair-wise comparison between the Adjusted Seroresponses in Cohort B Placebo group and the Cohort B P2-VP8 group was performed.|
1630531|NCT02109484|2995369|Equivalence|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide >= 89% and >= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide > 95% to detect >= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||A pair wise comparison between the Adjusted Seroresponses in the placebo group and the Cohort B 30 mcg P2-VP8 vaccine group was performed.|
1630532|NCT02109484|2995369|Equivalence|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide >= 89% and >= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide > 95% to detect >= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0004|||||||Wilcoxon (Mann-Whitney)|||A pair wise comparison between the Adjusted Seroresponses in the placebo group and the Group B 10 mcg P2-VP8 was performed.|
1630533|NCT02109484|2995370|Equivalence|Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were performed||||||0.0006|||||||Wilcoxon (Mann-Whitney)||||
1630534|NCT02109484|2995370|Equivalence|Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were performed|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1630535|NCT02109484|2995370|Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Pair-wise comparisons between Cohort B Placebo group and the active vaccination groups were peformed|
1630536|NCT02109484|2995371|Equivalence|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide >= 89% and >= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide > 95% to detect >= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1630537|NCT02109484|2995371|Equivalence|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide >= 89% and >= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide > 95% to detect >= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide >= 89% and >= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide > 95% to detect >= 40 percentage point difference between a P2-VP8 dose group and placebo group.|
1630538|NCT02109484|2995371|Equivalence|Power to detect difference between treatment groups for seroresponse between 50% and 95% for P2-VP8 subunit rotiarivus vaccine calculated based on estimate of 10% loss. 45 evaluable participants in 2 highest doses tolerated in B1 infant cohort, study idesigned to provide >= 89% and >= 77% power to detect 35 and 30 percentage points difference, respectively, between the two dose levels and provide > 95% to detect >= 40 percentage point difference between a P2-VP8 dose group and placebo group.|||||<|0.0165|||||||Wilcoxon (Mann-Whitney)||||
1630539|NCT02109419|2995410|Other||Chronbach's alpha|0.7|||||2-Sided|||||||||Internal consistency reliability of the HHT-G was assessed with Chronbach's alpha. The dataset included participants from all groups.|
1630540|NCT02109419|2995410|Other||Chronbach's alpha|0.73|||||2-Sided|||||||||Internal consistency reliability of the HHT-D was assessed with Chronbach's alpha. The dataset included participants from all groups.|
1630541|NCT02109419|2995410|Other||Pearson correlation coefficient|0.71||||0.0001|2-Sided||||||Pearson correlation coefficient|||Validity of the HHT-G was tested by Pearson correlation coefficients between HHT-G and Mini-Mental State Examination (MMSE) scores. The dataset included participants from all groups.|
1630542|NCT02109419|2995410|Other||Pearson correlation coefficient|0.6|||<|0.0001|2-Sided||||||Pearson correlation coefficient|||Validity of the HHT-D was tested by Pearson correlation coefficients between HHT-D and Geriatric Depression Scale (GDS) scores. The dataset included participants from all groups.|
1630543|NCT02109419|2995410|Other||Pearson test-retest reliability coeff|0.87|||<|0.0001|2-Sided||||||Pearson test-retest reliability coeff|||HHT-G reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.|
1630544|NCT02109419|2995410|Other||Pearson Test-retest reliability coeff.|0.8|||<|0.0001|2-Sided||||||Pearson Test-retest reliability coeff.|||HHT-D reliability was evaluated via test-retest reliability coefficients. The dataset included participants from all groups.|
1630545|NCT02109159|2995412|Superiority or Other||Mean Difference (Final Values)|0.2||||0.56|2-Sided|95.0|-0.5|0.8|||t-test, 2 sided||This analysis was conducted on a per-protocol (PP) basis including only those who watched the videos.||
1630548|NCT02109159|2995413|Superiority or Other||Risk Ratio (RR)|1.2||||0.44|2-Sided|95.0|0.8|1.4|||Chi-squared||This analysis was conducted on an intention-to-treat (ITT) basis including all participants randomised.||
1630549|NCT02109107|2995419|Superiority or Other||||||<|0.005|||||||t-test, 2 sided|t+3.34; df=53|||
1630550|NCT02109107|2995420|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|t=2.95; df=53|||
1630551|NCT02109107|2995421|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|t=21.33; df=53|||
1630552|NCT02107898|2995563|Superiority or Other||LS Mean Difference|6.3|||<|0.0001|2-Sided|95.0|3.6|9.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630553|NCT02107898|2995564|Superiority or Other||LS Mean Difference|6.5|||<|0.0001|2-Sided|95.0|3.7|9.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630554|NCT02107898|2995565|Superiority or Other||Adjusted Mean Difference|-15.5||||0.0007|2-Sided|95.0|-24.4|-6.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630555|NCT02107898|2995566|Superiority or Other||Adjusted Mean Difference|-41.4|||<|0.0001|2-Sided|95.0|-47.0|-35.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630556|NCT02107898|2995567|Superiority or Other||LS Mean Difference|4.0||||0.0382|2-Sided|95.0|0.2|7.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630557|NCT02107898|2995568|Superiority or Other||LS Mean Difference|5.8||||0.002|2-Sided|95.0|2.1|9.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630558|NCT02107898|2995569|Superiority or Other||Adjusted Mean Difference|-22.0|||<|0.0001|2-Sided|95.0|-30.9|-13.1||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630559|NCT02107898|2995570|Superiority or Other||Adjusted Mean Difference|-42.0|||<|0.0001|2-Sided|95.0|-48.0|-36.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630560|NCT02107898|2995571|Superiority or Other||Odds Ratio (OR)|1367.8|||<|0.0001|2-Sided|95.0|137.8|13578.3||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630561|NCT02107898|2995572|Superiority or Other||Odds Ratio (OR)|552.1|||<|0.0001|2-Sided|95.0|105.6|2886.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630562|NCT02107898|2995573|Superiority or Other||LS Mean Difference|-39.0|||<|0.0001|2-Sided|95.0|-41.7|-36.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630563|NCT02107898|2995574|Superiority or Other||LS Mean Difference|-54.5|||<|0.0001|2-Sided|95.0|-57.9|-51.1|||Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630564|NCT02107898|2995575|Superiority or Other||LS Mean Difference|-51.2|||<|0.0001|2-Sided|95.0|-54.9|-47.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630565|NCT02107898|2995576|Superiority or Other||LS Mean Difference|-41.5|||<|0.0001|2-Sided|95.0|-44.6|-38.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630566|NCT02107898|2995577|Superiority or Other||LS Mean Difference|-58.6|||<|0.0001|2-Sided|95.0|-62.3|-54.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630567|NCT02107898|2995578|Superiority or Other||LS Mean Difference|-57.5|||<|0.0001|2-Sided|95.0|-61.5|-53.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630568|NCT02107898|2995579|Superiority or Other||LS Mean Difference|-53.8|||<|0.0001|2-Sided|95.0|-57.8|-49.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630569|NCT02107898|2995580|Superiority or Other||LS Mean Difference|-53.3|||<|0.0001|2-Sided|95.0|-57.5|-49.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630570|NCT02107898|2995581|Superiority or Other||LS Mean Difference|-62.1|||<|0.0001|2-Sided|95.0|-65.8|-58.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630603|NCT02107014|2995669|Superiority or Other|||||||0.753|||||||Mixed Models Analysis||||
1630571|NCT02107898|2995582|Superiority or Other||LS Mean Difference|-61.5|||<|0.0001|2-Sided|95.0|-65.3|-57.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1630572|NCT02107898|2995583|Superiority or Other||LS Mean Difference|-65.3|||<|0.0001|2-Sided|95.0|-69.4|-61.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|
1630573|NCT02107898|2995584|Superiority or Other||LS Mean Difference|-64.1|||<|0.0001|2-Sided|95.0|-68.5|-59.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.|
1630574|NCT02107703|2995606|Other||Hazard Ratio (HR)|0.553|||<|1e-07|2-Sided|95.0|0.449|0.681||This is two sided P value and it is statistically significant.|Log Rank|Log rank test is stratified by endocrine sensitivity and natural of disease by interactive web response system (IWRS).||The final analysis was planned at 378 PFS events, which would provide approximately 90% power assuming a hazard ratio (HR) of 0.703 at a one-sided α of 0.025.|
1630575|NCT02107599|2995607|Superiority or Other|||||||0.026|||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.|
1630576|NCT02107599|2995607|Superiority or Other|||||||0.1229|||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.|
1630577|NCT02107599|2995607|Superiority or Other|||||||0.006|||||||Monte Carlo test|||Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation.|
1630578|NCT02107599|2995608|Superiority or Other|||||||0.0001|||||||Asymptotic Z-test||||
1630579|NCT02107443|2995614|Superiority||Mean Difference (Final Values)|1.09||||0.041|2-Sided|95.0|||||Mixed Models Analysis||||
1630580|NCT02107443|2995615|Superiority||Mean Difference (Final Values)|3.59|||<|0.0001|2-Sided|95.0|||||Mixed Models Analysis||||
1630581|NCT02107274|2995636|Superiority or Other||||||<|0.01||||||p value of less than 0.05 was considered significant.|t-test, 1 sided|||"FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."|
1630582|NCT02107274|2995636|Superiority or Other||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"FVC values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."|
1630583|NCT02107274|2995637|Superiority or Other||||||<|0.01||||||p value of less than 0.05 was considered significant|t-test, 1 sided|||"FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."|
1630584|NCT02107274|2995637|Superiority or Other||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"FEV1 values were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."|
1630585|NCT02107274|2995638|Superiority or Other||||||<|0.01||||||p valu of less than 0.05 was considered significant.|t-test, 1 sided|||"SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables"|
1630586|NCT02107274|2995638|Superiority or Other||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"SGRQ scores were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."|
1630587|NCT02107274|2995639|Superiority or Other||||||<|0.01||||||P value of less than 0.05 was considered significant.|t-test, 1 sided|||"Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."|
1630588|NCT02107274|2995639|Superiority or Other||||||<|0.01||||||P value of less than 0.05 was considered as significant.|t-test, 1 sided|||"Sputum volume were compared between Visit 6 (Week 12) and Visit 3 (Baseline), Visit 8 (Week 24) and Visit 3 (Baseline), as well for Visit 8 (Week 24) and Visit 6 (Week 12).~Independent t-test was applied for study end points which were numerical variables."|
1630589|NCT02107014|2995651|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1630590|NCT02107014|2995652|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1630591|NCT02107014|2995653|Superiority or Other|||||||0.967|||||||Mixed Models Analysis||||
1630592|NCT02107014|2995656|Superiority or Other|||||||0.041|||||||Mixed Models Analysis||||
1630593|NCT02107014|2995657|Superiority or Other|||||||0.893|||||||Mixed Models Analysis||||
1630594|NCT02107014|2995658|Superiority or Other|||||||0.61|||||||Mixed Models Analysis||||
1630595|NCT02107014|2995659|Superiority or Other|||||||0.948|||||||Mixed Models Analysis||||
1630596|NCT02107014|2995660|Superiority or Other|||||||0.03|||||||Mixed Models Analysis||||
1630597|NCT02107014|2995661|Superiority or Other|||||||0.281|||||||Mixed Models Analysis||||
1630598|NCT02107014|2995662|Superiority or Other|||||||0.038|||||||Mixed Models Analysis||||
1630599|NCT02107014|2995663|Superiority or Other|||||||0.945|||||||Mixed Models Analysis||||
1630600|NCT02107014|2995666|Superiority or Other|||||||0.639|||||||Mixed Models Analysis||||
1630601|NCT02107014|2995667|Superiority or Other|||||||0.08|||||||Mixed Models Analysis||||
1630602|NCT02107014|2995668|Superiority or Other|||||||0.067|||||||Mixed Models Analysis||||
1630605|NCT02107014|2995671|Superiority or Other|||||||0.119|||||||Mixed Models Analysis||||
1630606|NCT02107014|2995672|Superiority or Other|||||||0.508|||||||Mixed Models Analysis||||
1630607|NCT02107014|2995674|Superiority or Other|||||||0.002|||||||Mixed Models Analysis||||
1630608|NCT02107014|2995675|Superiority or Other|||||||0.032|||||||Mixed Models Analysis||||
1630609|NCT02107014|2995676|Superiority or Other|||||||0.038|||||||Mixed Models Analysis||||
1630610|NCT02107014|2995677|Superiority or Other|||||||0.007|||||||Mixed Models Analysis||||
1630611|NCT02107014|2995678|Superiority or Other|||||||0.006|||||||Mixed Models Analysis||||
1630612|NCT02107014|2995679|Superiority or Other|||||||0.016|||||||Mixed Models Analysis||||
1630613|NCT02107014|2995680|Superiority or Other|||||||0.201|||||||Mixed Models Analysis||||
1630614|NCT02107014|2995681|Superiority or Other|||||||0.402|||||||Mixed Models Analysis||||
1630615|NCT02107014|2995682|Superiority or Other|||||||0.962|||||||Mixed Models Analysis||||
1630616|NCT02107014|2995683|Superiority or Other|||||||0.065|||||||Mixed Models Analysis||||
1630617|NCT02107014|2995684|Superiority or Other|||||||0.128|||||||Mixed Models Analysis||||
1630618|NCT02107014|2995685|Superiority or Other|||||||0.248|||||||Mixed Models Analysis||||
1630619|NCT02107014|2995686|Superiority or Other|||||||0.655|||||||Mixed Models Analysis||||
1630620|NCT02107014|2995687|Superiority or Other|||||||0.35|||||||Mixed Models Analysis||||
1630621|NCT02107014|2995688|Superiority or Other|||||||0.558|||||||Mixed Models Analysis||||
1630622|NCT02107014|2995689|Superiority or Other|||||||0.708|||||||Mixed Models Analysis||||
1630623|NCT02107014|2995690|Superiority or Other|||||||0.042|||||||Mixed Models Analysis||||
1630624|NCT02107014|2995691|Superiority or Other|||||||0.426|||||||Mixed Models Analysis||||
1630625|NCT02107014|2995692|Superiority or Other|||||||0.012|||||||Mixed Models Analysis||||
1630626|NCT02107014|2995693|Superiority or Other|||||||0.025|||||||Mixed Models Analysis||||
1630627|NCT02107014|2995694|Superiority or Other|||||||0.016|||||||Mixed Models Analysis||||
1630628|NCT02107014|2995697|Superiority or Other|||||||0.478|||||||Mixed Models Analysis||||
1630629|NCT02107014|2995698|Superiority or Other|||||||0.088|||||||Mixed Models Analysis||||
1630630|NCT02107014|2995699|Superiority or Other|||||||0.191|||||||Mixed Models Analysis||||
1630631|NCT02107014|2995700|Superiority or Other|||||||0.003|||||||Mixed Models Analysis||||
1630632|NCT02107014|2995701|Superiority or Other|||||||0.002|||||||Mixed Models Analysis||||
1630633|NCT02107014|2995702|Superiority or Other|||||||0.047|||||||Mixed Models Analysis||||
1630634|NCT02107014|2995703|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1630635|NCT02107014|2995704|Superiority or Other|||||||0.004|||||||Mixed Models Analysis||||
1630636|NCT02107014|2995705|Superiority or Other|||||||0.008|||||||Mixed Models Analysis||||
1630637|NCT02107014|2995708|Superiority or Other|||||||0.212|||||||Mixed Models Analysis||||
1630638|NCT02107014|2995709|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1630639|NCT02107014|2995710|Superiority or Other|||||||0.016|||||||Mixed Models Analysis||||
1630640|NCT02107014|2995711|Superiority or Other|||||||0.007|||||||Mixed Models Analysis||||
1630641|NCT02107014|2995712|Superiority or Other|||||||0.015|||||||Mixed Models Analysis||||
1630642|NCT02107014|2995713|Superiority or Other|||||||0.008|||||||Mixed Models Analysis||||
1630643|NCT02107014|2995714|Superiority or Other|||||||0.01|||||||Mixed Models Analysis||||
1630644|NCT02107014|2995715|Superiority or Other|||||||0.576|||||||Mixed Models Analysis||||
1630645|NCT02106923|2995739|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|103.9|Standard Error of the Mean|1.06||0.0021|2-Sided|90.0|94.09|114.74|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)||
1630646|NCT02106923|2995739|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.71|Standard Error of the Mean|1.02|<|0.0001|2-Sided|90.0|94.77|102.8|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)||
1630647|NCT02106923|2995739|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.33|Standard Error of the Mean|1.06|<|0.0008|2-Sided|90.0|89.13|108.47|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)||
1630648|NCT02106923|2995740|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|103.62|Standard Error of the Mean|1.071||0.006|2-Sided|90.0|92.116|116.559|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)||
1630649|NCT02106923|2995740|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|108.18|Standard Error of the Mean|1.03|<|0.0001|2-Sided|90.0|102.792|113.859|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)||
1630650|NCT02106923|2995740|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.94|Standard Deviation|1.071|<|0.0027|2-Sided|90.0|87.925|111.329|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)||
1630651|NCT02106923|2995741|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.03|Standard Error of the Mean|1.037|<|0.0001|2-Sided|90.0|90.217|102.211|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)||
1631245|NCT02095145|2996892|Other|||||||0.269|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Benign p-value|
1630652|NCT02106923|2995741|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|101.84|Standard Error of the Mean|1.041|<|0.0001|2-Sided|90.0|95.03|109.134|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)||
1630653|NCT02106923|2995741|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|104.83|Standard Error of the Mean|1.031|<|0.0001|2-Sided|90.0|99.522|110.412|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)||
1630654|NCT02106923|2995742|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.49|Standard Error of the Mean|1.017|<|0.0001|2-Sided|90.0|93.758|99.311|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)||
1630655|NCT02106923|2995742|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|100.03|Standard Error of the Mean|1.021|<|0.0001|2-Sided|90.0|96.448|103.738|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)||
1630656|NCT02106923|2995742|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.88|Standard Error of the Mean|1.014|<|0.0001|2-Sided|90.0|100.446|105.373|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)||
1630657|NCT02106923|2995743|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|101.7|Standard Error of the Mean|1.05||0.0002|2-Sided|90.0|93.59|110.52|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)||
1630658|NCT02106923|2995743|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|98.93|Standard Error of the Mean|1.02|<|0.0001|2-Sided|90.0|95.45|102.53|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)||
1630659|NCT02106923|2995743|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.04|Standard Error of the Mean|1.06|<|0.0011|2-Sided|90.0|92.3|112.81|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)||
1630660|NCT02106923|2995744|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|96.08|Standard Error of the Mean|1.016|<|0.0001|2-Sided|90.0|93.507|98.721|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1500 mg Met FDC (Fasted) divided by Empa/ 1500 mg Glumetza® (Fasted)||
1630661|NCT02106923|2995744|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|100.25|Standard Error of the Mean|1.021|<|0.0001|2-Sided|90.0|96.809|103.823|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fed) divided by Empa/1000 mg Glumetza ® (Fed)||
1630662|NCT02106923|2995744|Non-Inferiority or Equivalence|Model includes effects for sequence, subjects within sequences, period and treatment.|Adjusted geometric mean ratio (%)|102.98|Standard Error of the Mean|1.014|<|0.0001|2-Sided|90.0|100.505|105.514|||ANOVA|P-value for ratio outside interval 80%-125%|Ratio calculated as Empa/ 1000 mg Met FDC (Fasted) divided by Empa/1000 mg Glumetza® (Fasted)||
1630663|NCT02106832|2995753|Superiority or Other||Hazard Ratio (HR)|0.8662||||0.3965|2-Sided|95.1|0.6206|1.209|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 95.1% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.|
1630664|NCT02106832|2995761|Superiority or Other||Hazard Ratio (HR)|0.7062||||0.0511|2-Sided|99.9|0.3928|1.2698|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 99.9% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.|
1630665|NCT02106403|2995797|Superiority or Other||Mean Difference (Net)|4.39||||0.1482|2-Sided|95.0|-1.59|10.36|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.|
1630666|NCT02106403|2995797|Superiority or Other||Mean Difference (Net)|2.02||||0.503|2-Sided|95.0|-3.95|8.0|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.|
1630667|NCT02106403|2995797|Superiority or Other||Mean Difference (Net)|6.41||||0.0357|2-Sided|95.0|0.44|12.38|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.|
1630668|NCT02106403|2995798|Superiority or Other||Mean Difference (Net)|14.32|||<|0.0001|2-Sided|95.0|8.41|20.22|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.|
1631246|NCT02095145|2996892|Other|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Tumor p-value|
1630669|NCT02106403|2995798|Superiority or Other||Mean Difference (Net)|-2.18|||<|0.4645|2-Sided|95.0|-8.09|3.72|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.|
1630670|NCT02106403|2995798|Superiority or Other||Mean Difference (Net)|12.13|||<|0.0001|2-Sided|95.0|6.23|18.04|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.|
1630671|NCT02106403|2995799|Superiority or Other||Mean Difference (Net)|9.73||||0.0069|2-Sided|95.0|2.74|16.73|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.|
1630672|NCT02106403|2995799|Superiority or Other||Mean Difference (Net)|1.69||||0.6323|2-Sided|95.0|-5.31|8.69|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.|
1630673|NCT02106403|2995799|Superiority or Other||Mean Difference (Net)|11.43||||0.0016|2-Sided|95.0|4.43|18.42|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.|
1630674|NCT02106403|2995800|Superiority or Other||Mean Difference (Net)|0.48||||0.8711|2-Sided|95.0|-5.35|6.31|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.|
1630675|NCT02106403|2995800|Superiority or Other||Mean Difference (Net)|4.99||||0.0928|2-Sided|95.0|-0.84|10.81|||ANCOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.|
1630676|NCT02106403|2995800|Superiority or Other||Mean Difference (Net)|5.46||||0.0659|2-Sided|95.0|-0.37|11.29|||ANOVA|Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.|Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.|The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.|
1630677|NCT02106390|2995832|Non-Inferiority|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was > 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.05|||||2-Sided|95.0|0.82|1.35||||||Serogroup Y-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup Y at one month after the fourth vaccination.|
1630678|NCT02106390|2995832|Non-Inferiority|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was > 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.34|||||2-Sided|95.0|1.04|1.74||||||Serogroup W-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup W-135 at one month after the fourth vaccination.|
1630679|NCT02106390|2995832|Non-Inferiority|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was > 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|1.07|||||2-Sided|95.0|0.83|1.38||||||Serogroup C-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup C at one month after the fourth vaccination.|
1630680|NCT02106390|2995832|Non-Inferiority|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMVNZ + MenACWY versus MenACWY) was > 0.5 for all serogroups A, C, W-135 and Y.|GMT ratio|2.48|||||2-Sided|95.0|1.97|3.11||||||Serogroup A-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for serogroup A at one month after the fourth vaccination.|
1630681|NCT02106390|2995833|Non-Inferiority|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is > 0.5 for all serogroup B indicator strains.|GMT ratio|1.03|||||2-Sided|95.0|0.77|1.4||||||M10713-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the M10713 serogroup B indicator strain,at one month after the fourth vaccination.|
1630682|NCT02106390|2995833|Non-Inferiority|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is > 0.5 for all serogroup B indicator strains.|GMT ratio|1.01|||||2-Sided|95.0|0.82|1.25||||||NZ98/254-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the NZ98/254 serogroup B indicator strain,at one month after the fourth vaccination.|
1630683|NCT02106390|2995833|Non-Inferiority|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is > 0.5 for all serogroup B indicator strains.|GMT ratio|1.03|||||2-Sided|95.0|0.74|1.45||||||5/99-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the 5/99 serogroup B indicator strain,at one month after the fourth vaccination.|
1630684|NCT02106390|2995833|Non-Inferiority|Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is > 0.5 for all serogroup B indicator strains.|GMT ratio|0.89|||||2-Sided|95.0|0.71|1.1||||||"H44/76- The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the H44/76 serogroup B indicator strain,at one month after the fourth vaccination."|
1630685|NCT02106351|2995841|Superiority||LS mean difference|0.5||||0.7429|2-Sided|95.0|-2.6|3.7||The two-tailed significance level was 0.05.|ANOVA|||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using ANOVA on the GAS Total score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects.|
1630686|NCT02106351|2995841|Superiority||LS mean difference|0.5||||0.7648|2-Sided|95.0|-2.7|3.7||The two-tailed significance level was 0.05.|ANOVA|||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using ANOVA on the GAS Total score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects.|
1630687|NCT02106351|2995842|Superiority||LS mean difference back transformed|0.2||||0.188|2-Sided|||||The two-tailed significance level was 0.05.|ANOVA|ANOVA was performed on ranked values.||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using an ANOVA on the rank of the PGA score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.|
1630688|NCT02106351|2995842|Superiority||LS mean difference back transformed|0.2||||0.2043|2-Sided|||||The two-tailed significance level was 0.05.|ANOVA|ANOVA was performed on ranked values.||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using an analysis of variance (ANOVA) on the rank of the PGA score at TC 1, Week 6. The model included treatment group, the 2 stratification factors (age range and BTX status at baseline) and the centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.|
1630689|NCT02106351|2995843|Superiority||LS mean difference back transformed|-0.7|||<|0.0001|2-Sided|||||The 2-tailed significance level was 0.05.|ANCOVA|ANCOVA is performed on the ranked values.||The treatment difference between Dysport 16 U/kg and Dysport 2 U/kg was analysed using an ANCOVA on the ranked changes from baseline. The model included treatment group, the baseline value, the 2 stratification factors (age range and BTX status at baseline) and the pooled centre as fixed effects. The derived LS means were back transformed to the original scale and the treatment difference determined.|
1630690|NCT02106351|2995843|Superiority||LS mean difference back transformed|-0.4|||<|0.0118|2-Sided|||||The 2-tailed significance level was 0.05.|ANCOVA|ANCOVA is performed on the ranked values.||The treatment difference between Dysport 8 U/kg and Dysport 2 U/kg was analysed using an analysis of covariance (ANCOVA) on the ranked changes from baseline. The model included treatment group, the baseline value, the 2 stratification factors (age range and BTX status at baseline) and the pooled centre as fixed effects. The derived least squares (LS) means were back transformed to the original scale and the treatment difference determined.|
1630691|NCT02105987|2995863|Superiority or Other||Geometric Mean Ratio|1.01||||0.687|2-Sided|95.0|0.98|1.03|||ANCOVA||||
1630692|NCT02105987|2995864|Superiority or Other||Geometric Mean Ratio|1.01||||0.577|2-Sided|95.0|0.97|1.06|||ANCOVA||||
1630693|NCT02105987|2995865|Superiority or Other||Geometric Mean Ratio|0.97||||0.645|2-Sided|95.0|0.87|1.09|||ANCOVA||||
1630694|NCT02105987|2995866|Superiority or Other||Geometric Mean Ratio|0.97||||0.64|2-Sided|95.0|0.85|1.11|||ANCOVA||||
1630695|NCT02105987|2995867|Superiority or Other||Geometric Mean Ratio|1.0||||0.981|2-Sided|95.0|0.91|1.1|||ANCOVA||||
1630696|NCT02105987|2995868|Superiority or Other||Geometric Mean Ratio|1.0||||0.999|2-Sided|95.0|0.84|1.19|||ANCOVA||||
1630697|NCT02105987|2995869|Superiority or Other||Geometric Mean ratio|1.01||||0.742|2-Sided|95.0|0.95|1.08||Soluble vasc cell adhesion molecule 1|ANCOVA||||
1630698|NCT02105987|2995869|Superiority or Other||Geometric Mean ratio|0.92|||<|0.001|2-Sided|95.0|0.89|0.96||Soluble CD14|ANCOVA||||
1630699|NCT02105987|2995869|Superiority or Other||Geometric Mean ratio|1.08|||<|0.311|2-Sided|95.0|0.93|1.24||Interleukin 6|ANCOVA||||
1630700|NCT02105987|2995869|Superiority or Other||Geometric Mean ratio|0.64|||<|0.001|2-Sided|95.0|0.57|0.72||Fatty acid binding protein 2|ANCOVA||||
1630701|NCT02105987|2995870|Superiority or Other||Geometric Mean Ratio|0.91||||0.001|2-Sided|95.0|0.86|0.96||Type I collagen c-telopeptides|ANCOVA||||
1630702|NCT02105987|2995870|Superiority or Other||Geometric Mean Ratio|-0.09||||0.001|2-Sided|95.0|-0.15|-0.04||Procollagen 1 n-terminal propeptide|ANCOVA||||
1630703|NCT02105987|2995870|Superiority or Other||Geometric Mean Ratio|0.91||||0.002|2-Sided|95.0|0.85|0.96||Osteocalcin|ANCOVA||||
1630704|NCT02105987|2995870|Superiority or Other||Geometric Mean Ratio|0.86|||<|0.001|2-Sided|95.0|0.82|0.9||Bone specific alkaline phosphatase|ANCOVA||||
1630705|NCT02105987|2995871|Superiority or Other||Mean Difference (Final Values)|0.18||||0.749|2-Sided|95.0|-0.93|1.3|||ANCOVA||||
1630706|NCT02105987|2995872|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.375|2-Sided|95.0|-0.31|0.12|||ANCOVA||||
1630707|NCT02105987|2995873|Superiority or Other||Mean Difference (Final Values)|-0.13|||<|0.001|2-Sided|95.0|-0.17|-0.1|||ANCOVA||||
1630708|NCT02105987|2995874|Superiority or Other||Mean Difference (Final Values)|-6.87|||<|0.001|2-Sided|95.0|-8.64|-5.11|||ANCOVA||||
1630709|NCT02105987|2995875|Superiority or Other||Mean Difference (Final Values)|6.51|||<|0.001|2-Sided|95.0|4.86|8.16|||ANCOVA||||
1630710|NCT02105987|2995876|Superiority or Other||Mean Difference (Net)|1.3|||<|0.001|2-Sided|95.0|0.8|1.8|||ANCOVA||Statistical analysis for lifestyle/ease subscale is presented||
1630711|NCT02105987|2995876|Superiority or Other||Mean Difference (Net)|1.0|||<|0.002|2-Sided|95.0|0.4|1.7|||ANCOVA||Statistical analysis for general satisfaction/clinical subscale score is presented||
1630712|NCT02105987|2995876|Superiority or Other||Mean Difference (Net)|2.4|||<|0.001|2-Sided|95.0|1.3|3.5|||ANCOVA||Statistical analysis for total score is presented||
1630713|NCT02105987|2995877|Superiority or Other||Mean Difference (Final Values)|0.1||||0.175|2-Sided|95.0|-0.04|0.25|||ANCOVA||Statistical analysis of total cholesterol/HDL cholesterol ratio is presented||
1630714|NCT02105987|2995878|Superiority or Other||Mean Difference (Final Values)|0.11||||0.187|2-Sided|95.0|-0.05|0.27|||ANCOVA||Statistical analysis of triglycerides is presented||
1630715|NCT02105987|2995878|Superiority or Other||Median Difference (Final Values)|0.02||||0.317|2-Sided|95.0|-0.02|0.06|||ANCOVA||Statistical analysis of HDL cholesterol is presented||
1630716|NCT02105987|2995878|Superiority or Other||Median Difference (Final Values)|0.07||||0.167|2-Sided|95.0|-0.03|0.18|||ANCOVA||Statistical analysis of LDL cholesterol is presented||
1630717|NCT02105987|2995878|Superiority or Other||Mean Difference (Final Values)|0.11||||0.096|2-Sided|95.0|-0.02|0.23|||ANCOVA||Statistical analysis of cholesterol is presented||
1630718|NCT02105987|2995883|Superiority or Other||Mean Difference (Net)|-0.3|||||2-Sided|95.0|-2.0|1.4|||||Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).||
1630719|NCT02105987|2995885|Non-Inferiority or Equivalence|The non-inferiority margin is -10%.|Mean Difference (Net)|-3.4|||||2-Sided|95.0|-9.1|2.4|||||Based on Cochran-Mantel Haenszel stratified analysis adjusting for the following Baseline stratification factor: Original ART third agent class (PI, NNRTI, or INI).||
1630720|NCT02105974|2995886|Superiority or Other||Hazard Ratio (HR)|0.58|||<|0.001|2-Sided|95.0|0.43|0.78||Nominal p-value|Regression, Cox||||
1630721|NCT02105974|2995887|Superiority or Other||Least Squares Mean Difference|2.62||||0.084|2-Sided|95.0|-0.35|5.59|||ANCOVA||||
1630722|NCT02105974|2995888|Superiority or Other||Least Squares Mean Difference|0.034||||0.001|2-Sided|95.0|0.014|0.055|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|||
1630723|NCT02105961|2995889|Superiority||Mean difference(Mepolizumab 300-Placebo)|-0.4||||0.547|2-Sided|95.0|-1.5|0.8||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630724|NCT02105961|2995889|Superiority||Mean difference(Mepolizumab 300-Placebo)|-0.4||||0.926|2-Sided|95.0|-1.5|0.8||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630725|NCT02105961|2995889|Superiority||Mean difference(Mepolizumab 100-Placebo)|-1.1||||0.055|2-Sided|95.0|-2.3|0.0||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630726|NCT02105961|2995889|Superiority||Mean difference(Mepolizumab 100-Placebo)|-1.1||||0.926|2-Sided|95.0|-2.3|0.0||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630727|NCT02105961|2995890|Superiority||Mean difference(Mepolizumab 300-Placebo)|-0.1||||0.926|2-Sided|95.0|-2.8|2.6||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630728|NCT02105961|2995890|Superiority||Mean difference(Mepolizumab 300-Placebo)|-0.1||||0.926|2-Sided|95.0|-2.8|2.6||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630729|NCT02105961|2995890|Superiority||Mean difference(Mepolizumab 100-Placebo)|-1.8||||0.18|2-Sided|95.0|-4.5|0.8||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630730|NCT02105961|2995890|Superiority||Mean difference(Mepolizumab 100-Placebo)|-1.8||||0.447|2-Sided|95.0|-4.5|0.8||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of Baseline SGRQ total score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630731|NCT02105961|2995891|Superiority||Rate ratio (Mepolizumab 300/Placebo)|0.83||||0.447|2-Sided|95.0|0.51|1.34||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)||
1630732|NCT02105961|2995891|Superiority||Rate ratio (Mepolizumab 300/Placebo)|0.83||||0.447|2-Sided|95.0|0.51|1.34||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)||
1630769|NCT02105701|2995906|Superiority or Other||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate >58%.|
1631247|NCT02095145|2996892|Other|||||||0.903|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Adjacent p-value|
1630733|NCT02105961|2995891|Superiority||Rate ratio (Mepolizumab 100/Placebo)|0.59||||0.042|2-Sided|95.0|0.35|0.98||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)||
1630734|NCT02105961|2995891|Superiority||Rate ratio (Mepolizumab 100/Placebo)|0.59||||0.14|2-Sided|95.0|0.35|0.98||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)||
1630735|NCT02105961|2995892|Superiority||Hazard Ratio (Mepolizumab 300/Placebo)|0.77||||0.03|2-Sided|95.0|0.6|0.97||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status||
1630736|NCT02105961|2995892|Superiority||Hazard Ratio (Mepolizumab 300/Placebo)|0.77||||0.14|2-Sided|95.0|0.6|0.97||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status||
1630737|NCT02105961|2995892|Superiority||Hazard Ratio (Mepolizumab/Placebo)|0.82||||0.103|2-Sided|95.0|0.64|1.04||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status||
1630738|NCT02105961|2995892|Superiority||Hazard Ratio(Mepolizumab 100/Placebo)|0.82||||0.14|2-Sided|95.0|0.64|1.04||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, number of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status||
1630739|NCT02105961|2995893|Superiority||Rate ratio (Mepolizumab 300/Placebo)|0.86||||0.14|2-Sided|95.0|0.7|1.05||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)||
1630740|NCT02105961|2995893|Superiority||Rate ratio (Mepolizumab 300/Placebo)|0.86||||0.14|2-Sided|95.0|0.7|1.05||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period||
1630741|NCT02105961|2995893|Superiority||Rate ratio (Mepolizumab 100/Placebo)|0.8||||0.034|2-Sided|95.0|0.65|0.98||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)||
1630742|NCT02105961|2995893|Superiority||Rate ratio (Mepolizumab 100/Placebo)|0.8||||0.068|2-Sided|95.0|0.65|0.98||Adjusted p-value; Family wise type I error controlled within each endpoint using a Hochberg testing procedure|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off- treatment period)||
1630743|NCT02105948|2995894|Superiority||Mean difference (Mepolizumab - Placebo)|-0.6|||=|0|2-Sided|95.0|-1.5|0.4||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630744|NCT02105948|2995894|Superiority||Mean difference (Mepolizumab - Placebo)|-0.6|||>|0.999|2-Sided|95.0|-1.5|0.4||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630745|NCT02105948|2995895|Superiority||Mean difference (Mepolizumab - Placebo)|0.7|||=|0|2-Sided|95.0|-1.5|2.9||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630746|NCT02105948|2995895|Superiority||Mean difference (Mepolizumab - Placebo)|0.7|||>|0.999|2-Sided|95.0|-1.5|2.9||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630747|NCT02105948|2995896|Superiority||Rate ratio (mepolizumab/placebo)|1.1|||=|0|2-Sided|95.0|0.81|1.49||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).||
1630748|NCT02105948|2995896|Superiority||Rate ratio (mepolizumab/placebo)|1.1|||>|0.999|2-Sided|95.0|0.81|1.49||Adjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).||
1630749|NCT02105948|2995897|Superiority||Hazard ratio (Mepolizumab/Placebo)|0.89|||=|0|2-Sided|95.0|0.75|1.05||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status||
1631305|NCT02094898|2996921|Superiority||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.|
1630750|NCT02105948|2995897|Superiority||Hazard ratio (Mepolizumab/Placebo)|0.89|||>|0.999|2-Sided|95.0|0.75|1.05||Adjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status||
1630751|NCT02105948|2995898|Superiority||Mean Difference (Mepolizumab - Placebo)|-0.8|||=|0|2-Sided|95.0|-2.0|0.5||Unadjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630752|NCT02105948|2995898|Superiority||Mean Difference (Mepolizumab - Placebo)|-0.8|||>|0.999|2-Sided|95.0|-2.0|0.5||Adjusted p-value|Mixed Model Repeated Measures Analysis||Analysis performed using mixed model repeated measures with covariates of baseline CAT score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630753|NCT02105948|2995899|Superiority||Mean Difference (Mepolizumab - Placebo)|0.2|||=|0|2-Sided|95.0|-2.8|3.2||Unadjusted p-value|Mixed Model Repeated Measure Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630754|NCT02105948|2995899|Superiority||Mean Difference (Mepolizumab - Placebo)|0.2|||>|0.999|2-Sided|95.0|-2.8|3.2||Adjusted p-value|Mixed Model Repeated Measure Analysis||Analysis performed using mixed model repeated measures with covariates of baseline SGRQ Total Score, geographic region, smoking status, treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group.||
1630755|NCT02105948|2995900|Superiority||Rate ratio (mepolizumab/placebo)|1.16|||=|0|2-Sided|95.0|0.77|1.75||Unadjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).||
1630756|NCT02105948|2995900|Superiority||Rate ratio (mepolizumab/placebo)|1.16|||=|0|2-Sided|95.0|0.77|1.75||Adjusted p-value|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period).||
1630757|NCT02105948|2995901|Superiority||Hazard ratio (Mepolizumab/placebo)|0.75|||=|0|2-Sided|95.0|0.6|0.94||Unadjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status||
1630758|NCT02105948|2995901|Superiority||Hazard ratio (Mepolizumab/placebo)|0.75|||=|0|2-Sided|95.0|0.6|0.94||Adjusted p-value|Cox Proportional Hazards Model||Analysis performed using a Cox Proportional Hazards Model with covariates of treatment, geographic region, no. moderate/severe exacerbations in previous year, Baseline percent predicted FEV1 and smoking status||
1630759|NCT02105948|2995902|Superiority||Rate ratio (mepolizumab/placebo)|0.98|||=|0|2-Sided|95.0|0.85|1.12||Unadjusted p-value.|Negative binomial mode||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)||
1630760|NCT02105948|2995902|Superiority||Rate ratio (mepolizumab/placebo)|0.98|||>|0.999|2-Sided|95.0|0.85|1.12||Adjusted p-value to account for two treatment comparisons|Negative Binomial Model||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)||
1630761|NCT02105948|2995903|Superiority||Rate ratio (mepolizumab/placebo)|0.82|||=|0|2-Sided|95.0|0.68|0.98||Unadjusted p-value.|Negative binomial mode||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted FEV1, smoking status and offset of log (time in on- and off-treatment period)||
1630762|NCT02105948|2995903|Superiority||Rate ratio (mepolizumab/placebo)|0.82|||=|0|2-Sided|95.0|0.68|0.98||Adjusted p-value to account for two treatment comparisons|Negative binomial model||Analysis using a negative binomial model with covariates of treatment, geographic region, no.of moderate/severe exacerbations in previous year, Baseline percent predicted for FEV1,smoking status and offset of log (time in on-and off-treatment period)||
1630763|NCT02105740|2995904|Superiority or Other||Mean Difference (Final Values)|1.5|||||2-Sided|||||||||Statistical analysis evaluated if the difference of averages of depression at the hypnosis and control groups in the third week.|
1630764|NCT02105740|2995904|Superiority or Other||Mean Difference (Final Values)|1.39|||||2-Sided|||||||||Statistical analysis evaluated if the difference of averages of anxiety at the hypnosis and control groups in the third week.|
1630765|NCT02105740|2995905|Superiority or Other||Mean Difference (Net)|5.25|Standard Deviation|0.827||0|2-Sided|95.0|2.918|7.582|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the third week in the hypnosis group.|
1630766|NCT02105740|2995905|Superiority or Other||Mean Difference (Net)|3.66|Standard Deviation|0.856||0.004|2-Sided|95.0|1.253|6.08|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the second week in the hypnosis group.|
1630767|NCT02105740|2995905|Superiority or Other||Mean Difference (Final Values)|2.67|Standard Deviation|1.178||0.034|2-Sided|95.0|0.224|5.11|||ANOVA|||The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) for both arms with a statistical power of 95%, significance level of 5%. Statistical analysis first compared the difference of means between hypnosis and control groups during three weeks.|
1630768|NCT02105701|2995906|Superiority or Other||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate >58%.|
1630770|NCT02105701|2995906|Superiority or Other||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate >58%.|
1630771|NCT02105701|2995906|Superiority or Other||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR24 rate >58%.|
1630772|NCT02105701|2995909|Superiority or Other||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate >58%.|
1630773|NCT02105701|2995909|Superiority or Other||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate >58%.|
1630774|NCT02105701|2995909|Superiority or Other||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate >58%.|
1630775|NCT02105701|2995909|Superiority or Other||||||<|0.001|||||||One-sided Exact Test|||The hypothesis was that at least 1 treatment arm would have a SVR12 rate >58%.|
1630776|NCT02105688|2995911|Superiority or Other (legacy)||Difference in Percentage|-0.5|||||2-Sided|95.0|-5.0|1.9||||||Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.|
1630777|NCT02105688|2995912|Superiority or Other (legacy)||Difference in Percentage|0.2|||||2-Sided|95.0|-8.3|10.0||||||Categorical AE parameters were assessed via point estimates with 95% confidence intervals provided for between-treatment differences in the percentage of participants with events using the Miettinen and Nurminen method, an unconditional, asymptotic method.|
1630778|NCT02105688|2995913|Superiority or Other (legacy)||||||<|0.001|||||||One-sided exact test|||A one-sided exact test was used to test the null hypothesis, which was that the SVR12 rate for the ITA was less than 67% (historical reference rate derived from NCT01667731). The p-value was based on a one-sided exact test for a binomial proportion. A one-sided p-value <0.025 supports a conclusion that the true SVR12 is >67%.|
1630779|NCT02105636|2995922|Superiority or Other (legacy)||Hazard Ratio (HR)|0.7||||0.0101|2-Sided|95.0|0.53|0.92||Log-rank Test stratified by prior treatment with cetuximab (yes, no) as entered into the Interactive Voice Response System (IVRS). For OS the boundary for statistical significance requires the p-value to be less than 0.0227.|Log Rank|||Stratified Cox proportional hazard model. HR = Nivolumab over investigator’s choice therapy (Cetuximab, Methotrexate, or Docetaxel)|
1630780|NCT02105467|2995937|Superiority or Other||Risk Difference (RD)|0.0|||||2-Sided|95.0|-4.4|2.0|||||Between-treatment difference (Immediate Treatment Group - Deferred Treatment Group) was analyzed using the Miettinen and Nurminen method.||
1630781|NCT02105467|2995938|Superiority or Other||Risk Difference (RD)|-1.0|||||2-Sided|95.0|-10.8|9.6|||||Between-treatment difference (Immediate Treatment Group - Deferred Treatment Group) was analyzed using the Miettinen and Nurminen method.||
1630782|NCT02105467|2995939|Superiority or Other||||||<|0.001|||||||One-sided, one-sample exact test|||Superiority of SVR12 in the Immediate Treatment group was tested against the historical response rate of 73%.|
1630783|NCT02105415|2995944|Superiority|||||||0.233|||||||ANCOVA||||
1630784|NCT02105415|2995945|Superiority|||||||0.994|||||||ANCOVA||||
1630785|NCT02105415|2995946|Superiority|||||||0.502|||||||ANCOVA|||Colloid|
1630786|NCT02105415|2995946|Superiority|||||||0.046|||||||ANCOVA|||Non-red blood cell|
1630787|NCT02105415|2995946|Superiority|||||||0.069|||||||ANCOVA|||Red blood cell|
1630788|NCT02105415|2995947|Superiority|||||||0.911|||||||ANCOVA||||
1630789|NCT02105415|2995949|Superiority|||||||0.691|||||||ANCOVA|||Delayed-onset pressors (within 24 hrs)|
1630790|NCT02105415|2995949|Superiority|||||||0.308|||||||ANCOVA|||New-onset pressors (within 3 minutes)|
1630791|NCT02105415|2995949|Superiority|||||||0.212|||||||ANCOVA|||Pre-treatment|
1630792|NCT02105415|2995950|Superiority|||||||0.605|||||||ANCOVA||||
1630793|NCT02105415|2995951|Superiority||Mean Difference (Final Values)|-0.8||||0.802|2-Sided|95.0|-7.2|5.6|||ANCOVA|||15 minutes|
1630794|NCT02105415|2995951|Superiority||Mean Difference (Final Values)|-4.0||||0.241|2-Sided|95.0|-10.8|2.8|||ANCOVA|||10 minutes|
1630795|NCT02105415|2995951|Superiority||Mean Difference (Final Values)|-2.1||||0.385|2-Sided|95.0|-6.9|2.7|||ANCOVA|||5 minutes|
1630796|NCT02105246|2996004|Non-Inferiority|This analysis compared 6-month change in 6-minute walk test distance among subjects who participated in home-based vs. center-based cardiac rehab.|Median Difference (Final Values)|159.0||||0.03|2-Sided||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: 6-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.|
1630797|NCT02105246|2996005|Non-Inferiority|This analysis compared Baseline to 3-month change in 6-minute walk test distance among subjects who participated in home-based cardiac rehab vs. subjects who participated in center-based cardiac rehab|Median Difference (Final Values)|196.0|||<|0.001|2-Sided|||||This comparison was unadjusted.|Wilcoxon (Mann-Whitney)|||Null hypothesis: 3-month change in 6MWT distance is not inferior among participants enrolled in home-based vs. facility-based cardiac rehab.|
1630798|NCT02105246|2996006|Equivalence|This analysis compared the proportion of eligible patients who participated in cardiac rehab after referral to home-based vs. referral to center-based programs.|Risk Ratio (RR)|0.98||||0.8|2-Sided||||||Chi-squared|||Null hypothesis = no difference in proportion of patients who participate in cardiac rehab after referral to home-based vs. facility-based programs|
1630799|NCT02104804|2996032|Superiority or Other||Difference in Least squares mean|-0.13|Standard Error of the Mean|0.16||0.43|2-Sided|95.0|-0.44|0.19|||ANCOVA||||
1630800|NCT02104804|2996033|Superiority or Other||Difference in Least Squares Mean|-15.88|Standard Error of the Mean|2.88|<|0.001|2-Sided|95.0|-21.53|-10.22|||ANCOVA||||
1630801|NCT02104804|2996034|Superiority or Other||Mean Difference (Final Values)|7.8||||0.002|2-Sided|95.0|3.1|12.6|||Difference in proportions||||
1630802|NCT02104804|2996035|Superiority or Other||Difference in Least squares mean|-39.11|Standard Error of the Mean|5.24|<|0.001|2-Sided|95.0|-49.41|-28.82|||ANCOVA||||
1630803|NCT02104804|2996036|Superiority or Other||Difference in Least Squares Mean|-6133.2|Standard Error of the Mean|781.06|<|0.001|2-Sided|95.0|-7668.5|-4597.9|||ANCOVA||||
1630804|NCT02104804|2996037|Superiority or Other||Difference in Least Squares Mean|-0.58|Standard Error of the Mean|0.07|<|0.001|2-Sided|95.0|-0.72|-0.45|||ANCOVA||||
1630805|NCT02104739|2996046|Superiority||||||>|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (3 hours, 6 hours).|
1630806|NCT02104739|2996046|Superiority||||||>|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (3 hours, 6 hours).|
1630807|NCT02104739|2996047|Superiority|||||||0.5|||||||ANOVA||||
1630808|NCT02104739|2996049|Superiority||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).|
1630809|NCT02104739|2996049|Superiority||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).|
1630810|NCT02104739|2996051|Superiority|||||||0.018|||||||ANOVA||||
1630811|NCT02104739|2996053|Superiority||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and placebo over all time points (2 hours, 4 hours, 6 hours).|
1630812|NCT02104739|2996053|Superiority||||||<|0.05|||||||ANOVA|||The reported p-value compares exenatide and saxagliptin over all time points (2 hours, 4 hours, 6 hours).|
1630813|NCT02104739|2996055|Superiority|||||||0.02|||||||ANOVA||||
1630814|NCT02104739|2996057|Superiority|||||||0.31|||||||Non-parametric Wilcoxon paired rank sum|||Exenatide extended-release (ER) at baseline and 2 hours after ingestion of meal is compared.|
1630815|NCT02104739|2996057|Superiority|||||||0.51|||||||Non-parametric Wilcoxon paired rank sum|||Placebo at baseline and 2 hours after ingestion of meal is compared.|
1630816|NCT02104739|2996057|Superiority|||||||0.59|||||||Non-parametric Wilcoxon paired rank sum|||Saxagliptin at baseline and 2 hours after ingestion of meal is compared.|
1630817|NCT02104739|2996057|Superiority|||||||0.27|||||||Non-parametric Wilcoxon paired rank sum|||Exenatide at baseline and 2 hours after ingestion of meal is compared.|
1630818|NCT02104583|2996068|Superiority||Eleclazine : Placebo Incident Rate Ratio|1.24||||0.618|2-Sided|95.0|0.54|2.86|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region [US or ROW.|
1630819|NCT02104583|2996068|Superiority||Eleclazine : Placebo Incident Rate Ratio|0.82||||0.662|2-Sided|95.0|0.34|1.97|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region [US or ROW].|
1630820|NCT02104583|2996068|Superiority||Eleclazine : Placebo Incident Rate Ratio|1.52||||0.152|2-Sided|95.0|0.86|2.71|||generalized linear model|||The primary analysis of overall occurrence of appropriate ICD interventions through Week 24 was performed using a generalized linear model assuming a negative binomial distribution and log link. This model included terms for treatment, implanted device (ICD or CRT-D) and region [US or rest of world (ROW)].|
1630821|NCT02104505|2996069|Superiority||Mean Difference (Net)|-0.32|Standard Error of the Mean|0.33||0.34|2-Sided||||||Mixed Models Analysis||||
1630822|NCT02104505|2996070|Superiority||Mean Difference (Net)|-0.32|Standard Error of the Mean|0.33||0.6|2-Sided||||||Mixed Models Analysis||||
1630823|NCT02104505|2996071|Superiority||Mean Difference (Net)|0.64|Standard Error of the Mean|0.22||0.01|2-Sided||||||Mixed Models Analysis||||
1630824|NCT02104505|2996072|Superiority||Mean Difference (Net)|0.41|Standard Error of the Mean|0.18||0.04|2-Sided||||||Mixed Models Analysis||Comparison of change in sputum %PMNs during active treatment vs placebo (crossover design).||
1630825|NCT02104219|2996083|Superiority or Other|||||||0.4545||||||The p-value is based on a nonparametric sign test used to determine whether change from baseline in the median RSS score differs from 0 for each time interval. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The Baseline x-ray set defined for RGI-C, which was compared with its subsequent x-ray sets, was also used as the Baseline x-ray set for the RSS reading. Changes from Baseline were computed based on this baseline RSS score, and postbaseline time points were grouped by intervals of time from Baseline.|
1630826|NCT02104219|2996084|Superiority or Other|||||||0.452||||||The p-value is based on a nonparametric sign test used to determine whether the median change in weight Z-score from baseline to last assessment differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The earliest documented weight measurement that was abstracted within the period from 5 to 15 years of age, inclusive, was defined as the baseline weight. Weight measurements were assigned to Z-scores calculated using Centers for Disease Control and Prevention 2000 growth charts and methodology. Changes in weight Z-score from Baseline were computed by subtracting baseline weight Z-score from post baseline weight Z-scores. The post baseline time points were grouped by time intervals.|
1630827|NCT02104219|2996085|Superiority or Other|||||||0.6344||||||The p-value is based on a nonparametric sign test used to determine whether the median change in height Z-score from baseline to last assessment differs from 0. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||The earliest documented height measurement that was abstracted within the period from 5 to 15 years of age, inclusive, was defined as the baseline height. Height measurements were assigned to Z-scores calculated using Centers for Disease Control and Prevention 2000 growth charts and methodology. Changes in height Z-score from Baseline were computed by subtracting baseline height Z-score from post baseline height Z-scores. The post baseline time points were grouped by time intervals.|
1630828|NCT02104219|2996086|Superiority or Other|||||||0.0755||||||The p-value is based on a nonparametric sign test used to determine whether the median RGI-C score differs from 0 for each time interval. No multiple comparisons or multiplicity adjustments were conducted.|Sign test|||Pairs of radiographs were centrally evaluated by 3 independent, blinded pediatric radiologists trained in the assessment of the skeletal manifestations of HPP. The mean RGI-C score across the 3 radiologists was calculated and served as the patient’s RGI-C score for a specific time point|
1630965|NCT02100670|2996313|Superiority or Other||Cox proportional hazard ratio|2.43||||0.0408|2-Sided|95.0|1.04|5.7||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.||
1631125|NCT02099110|2996461|Superiority or Other||Difference in % vs. Sitagliptin 100 mg|1.4|||||2-Sided|95.0|-7.4|10.1|||||Based on Miettinen & Nurminen method.||
1630829|NCT02104180|2996087|Non-Inferiority|An estimate of the difference between the pain felt by patient during the two dressings removals along with a 95% confidence interval (CI) has been derived. If the upper limit of the confidence interval was less than 13 mm, clinical non-inferiority of Tulle Gras versus Urgotul has been demonstrated.|Mean Difference (Final Values)|0.26|||||2-Sided|95.0|-1.339|1.864|||||The pain intensity has been analyzed using analysis of variance (ANOVA). The model for this cross-over study included sequence, period and treatment as fixed effects and subject within sequence as random effect.||
1630830|NCT02103439|2996102|Non-Inferiority or Equivalence|the lower limit of the 95 % confidence interval between the difference in rate of rapid virological response with Algeron and PegIntron should be more than the non-inferiority margin (-20 %)|||||>|0.05|||||||Fisher Exact||||
1630831|NCT02103439|2996103|Non-Inferiority or Equivalence|the lower limit of the 95% confidence interval for the difference in proportions between the difference in the early virological response rate with Algeron and PegIntron should be higher than the non-inferiority margin of 0.2 (-20%)||||||0.227|||||||Fisher Exact||||
1630832|NCT02103218|2996110|Superiority|||||||0.43|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630833|NCT02103218|2996111|Superiority|||||||0.29|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630834|NCT02103218|2996112|Superiority|||||||0.7|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630835|NCT02103218|2996113|Superiority|||||||0.46|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630836|NCT02103218|2996114|Superiority|||||||0.86|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630837|NCT02103218|2996116|Superiority|||||||0.5|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630838|NCT02103218|2996117|Superiority|||||||0.05||||||Omnibus overall test for any group x time interaction was p = 0.78.|count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630839|NCT02103218|2996118|Superiority|||||||0.63|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630840|NCT02103218|2996119|Superiority|||||||0.42|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630841|NCT02103218|2996120|Superiority|||||||0.7|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630842|NCT02103218|2996121|Superiority|||||||0.45|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630843|NCT02103218|2996122|Superiority|||||||0.67|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630844|NCT02103218|2996123|Superiority|||||||0.02||||||Omnibus overall test for any group x time interaction was p = 0.77.|linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630845|NCT02103218|2996124|Superiority||||||<|0.001|||||||linear GEE|||Results from linear GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630846|NCT02103218|2996125|Superiority|||||||0.29|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630847|NCT02103218|2996126|Superiority|||||||0.47|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630848|NCT02103218|2996127|Superiority|||||||0.15|||||||logistic GEE|||Results from logistic GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares predicted probabilities converted to %, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630849|NCT02103218|2996128|Superiority|||||||0.62|||||||count GEE|||Results from count GEE models for outcome with IPW propensity score adjustment and multiple imputation for missing data. Numbers presented above are model-based least-squares means, (SE). Overall p-values from omnibus test (group by time interaction) for any differences in change over time between groups as well as p-values from testing difference in least-square mean estimates in post-hoc pairwise comparisons with pre-intervention were estimated.|
1630850|NCT02103114|2996129|Superiority or Other (legacy)|||||||0.961|||||||t-test, 2 sided||||
1630851|NCT02103114|2996130|Superiority or Other (legacy)|||||||0.342|||||||Fisher Exact||||
1630852|NCT02103114|2996131|Superiority or Other (legacy)|||||||1|||||||Fisher Exact||||
1630853|NCT02103114|2996133|Superiority or Other (legacy)|||||||0.661|||||||Fisher Exact||||
1630854|NCT02103114|2996134|Superiority or Other (legacy)|||||||0.231|||||||Fisher Exact||||
1630855|NCT02103114|2996135|Superiority or Other (legacy)|||||||0.738|||||||t-test, 2 sided||||
1630856|NCT02103114|2996136|Superiority or Other (legacy)|||||||0.927|||||||t-test, 2 sided||||
1630857|NCT02103114|2996137|Equivalence|24 Hours Post-Operatively||||||0.0004|||||||Fisher Exact||||
1630858|NCT02103114|2996139|Equivalence|protamine time plus 24 hours||||||0.016|||||||Wilcoxon (Mann-Whitney)||||
1630859|NCT02103114|2996140|Superiority or Other (legacy)|||||||0.0196|||||||t-test, 2 sided|24 hour postop Red Blood Cell exposures|||
1630860|NCT02103114|2996140|Superiority or Other (legacy)|||||||0.073|||||||t-test, 2 sided|24 hour postop Cryoprecipitate exposures|||
1630861|NCT02103114|2996140|Superiority or Other (legacy)|||||||0.0351|||||||t-test, 2 sided|24 hour postop Platelet exposures|||
1630862|NCT02103114|2996140|Superiority or Other (legacy)|||||||0.2741|||||||t-test, 2 sided|24 hour postop Fresh Frozen Plasma exposures|||
1630863|NCT02103114|2996143|Equivalence|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)||||||0.757|||||||Wilcoxon (Mann-Whitney)||||
1630864|NCT02103114|2996145|Equivalence|T1 (Baseline) to T5 (Arrival in ICU)||||||0.545|||||||Wilcoxon (Mann-Whitney)||||
1630865|NCT02103114|2996146|Equivalence|T1 (Baseline) to T5 (Arrival in ICU)||||||0.056|||||||Wilcoxon (Mann-Whitney)||||
1630866|NCT02103114|2996149|Equivalence|T7 (POD 4)||||||0.008|||||||Wilcoxon (Mann-Whitney)||||
1630867|NCT02103114|2996149|Equivalence|T6 (POD 2)||||||0.313|||||||Wilcoxon (Mann-Whitney)||||
1630868|NCT02103114|2996149|Equivalence|T5 (Arrival in ICU)||||||0.225|||||||Wilcoxon (Mann-Whitney)||||
1630869|NCT02103114|2996149|Equivalence|T1 (Baseline)||||||0.855|||||||Wilcoxon (Mann-Whitney)||||
1630870|NCT02103114|2996150|Equivalence|T4 (just prior to coming off of CPB)||||||0.048|||||||Wilcoxon (Mann-Whitney)||||
1630871|NCT02103114|2996151|Equivalence|T7 (POD 4)||||||0.475|||||||t-test, 2 sided||||
1630872|NCT02103114|2996151|Equivalence|T6 (POD 2)||||||0.84|||||||t-test, 2 sided||||
1630873|NCT02103114|2996151|Equivalence|T5 (Arrival in ICU)||||||0.003|||||||t-test, 2 sided||||
1630874|NCT02103114|2996151|Equivalence|T3 (30 minutes on CPB)||||||0.001|||||||t-test, 2 sided||||
1630875|NCT02103114|2996151|Equivalence|T2 (30 minutes after study drug)|||||<|0.001|||||||t-test, 2 sided||||
1630876|NCT02103114|2996151|Equivalence|T1 (Baseline)|||||<|0.982|||||||t-test, 2 sided||||
1630877|NCT02102932|2996161|Superiority or Other||Ratio of the geometric means|93.84|Standard Deviation|13.6||0.0002|2-Sided|90.0|87.74|100.36||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1631239|NCT02095145|2996891|Other|||||||0.625|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value|
1630878|NCT02102932|2996161|Superiority or Other||Ratio of the geometric means|102.9|Standard Deviation|11.7||0|2-Sided|90.0|97.11|109.03||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630879|NCT02102932|2996161|Superiority or Other||Ratio of the geometric means|105.75|Standard Deviation|13.2||0.0001|2-Sided|90.0|99.09|112.85||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630880|NCT02102932|2996161|Superiority or Other||Ratio of the geometric means|105.33|Standard Deviation|11.9||0|2-Sided|90.0|99.34|111.68||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630881|NCT02102932|2996162|Superiority or Other||Ratio of the geometric means|102.61|Standard Deviation|7.0||0|2-Sided|90.0|99.1|106.25||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630882|NCT02102932|2996162|Superiority or Other||Ratio of the geometric means|103.14|Standard Deviation|7.5||0|2-Sided|90.0|99.37|107.04||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630883|NCT02102932|2996162|Superiority or Other||Ratio of the geometric means|103.07|Standard Deviation|6.6||0|2-Sided|90.0|99.75|106.5||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630884|NCT02102932|2996162|Superiority or Other||Ratio of the geometric means|105.16|Standard Deviation|6.2||0|2-Sided|90.0|101.97|108.45||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630885|NCT02102932|2996163|Superiority or Other||Ratio of the geometric means|96.61|Standard Deviation|16.9||0.0004|2-Sided|90.0|88.9|104.99||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630886|NCT02102932|2996163|Superiority or Other||Ratio of the geometric means|104.44|Standard Deviation|15.7||0.0003|2-Sided|90.0|96.68|112.82||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630887|NCT02102932|2996163|Superiority or Other||Ratio of the geometric means|106.32|Standard Deviation|15.7||0.0008|2-Sided|90.0|98.39|114.88||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630966|NCT02100670|2996317|Superiority or Other||Cox proportional hazard ratio|1.07||||0.6216|2-Sided|95.0|0.82|1.4||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.||
1630888|NCT02102932|2996163|Superiority or Other||Ratio of the geometric means|104.91|Standard Deviation|11.2||0|2-Sided|90.0|99.29|110.86||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630889|NCT02102932|2996164|Superiority or Other||Ratio of the geometric means|103.02|Standard Deviation|16.3||0.0002|2-Sided|90.0|95.08|111.63||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630890|NCT02102932|2996164|Superiority or Other||Ratio of the geometric means|101.38|Standard Deviation|13.6||0|2-Sided|90.0|94.82|108.39||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630891|NCT02102932|2996164|Superiority or Other||Ratio of the geometric means|110.78|Standard Deviation|13.2||0.0021|2-Sided|90.0|103.8|118.24||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630892|NCT02102932|2996164|Superiority or Other||Ratio of the geometric means|106.44|Standard Deviation|11.8||0|2-Sided|90.0|100.44|112.8||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630893|NCT02102932|2996165|Superiority or Other||Ratio of the geometric means|95.77|Standard Deviation|12.8||0|2-Sided|90.0|89.88|102.03||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630894|NCT02102932|2996165|Superiority or Other||Ratio of the geometric means|103.75|Standard Deviation|11.2||0|2-Sided|90.0|98.18|109.63||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630895|NCT02102932|2996165|Superiority or Other||Ratio of the geometric means|105.8|Standard Deviation|12.8||0.0001|2-Sided|90.0|99.32|112.7||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630896|NCT02102932|2996165|Superiority or Other||Ratio of the geometric means|104.56|Standard Deviation|14.0||0.0001|2-Sided|90.0|97.56|112.07||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630897|NCT02102932|2996166|Superiority or Other||Ratio of the geometric means|102.81|Standard Deviation|6.9||0|2-Sided|90.0|99.36|106.37||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T4) versus Reference (R4)) i.e. T4/R4. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630967|NCT02100670|2996317|Superiority or Other||Cox proportional hazard ratio|1.01||||0.9565|2-Sided|95.0|0.75|1.35||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.||
1630898|NCT02102932|2996166|Superiority or Other||Ratio of the geometric means|103.56|Standard Deviation|7.6||0|2-Sided|90.0|99.73|107.54||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T3) versus Reference (R3)) i.e. T3/R3. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630899|NCT02102932|2996166|Superiority or Other||Ratio of the geometric means|103.23|Standard Deviation|6.6||0|2-Sided|90.0|99.91|106.65||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T2) versus Reference (R2)) i.e. T2/R2. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630900|NCT02102932|2996166|Superiority or Other||Ratio of the geometric means|105.29|Standard Deviation|6.6||0|2-Sided|90.0|101.92|108.78||P-value for ratio outside interval 80-125|ANOVA||Ratio of the geometric means for treatments (Test (T1) versus Reference (R1)) i.e. T1/R1. The standard deviation is actually the intra-individual gCV.|"The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale. This model included effects accounting for the following sources of variation:~‘sequence’, ‘subjects within sequences’, ‘period’ and ‘treatment’. The effect ‘subjects within sequences’ was considered as random, whereas the other effects were considered as fixed."|
1630901|NCT02102724|2996167|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||The null hypotheses were that there are no differences between the two groups' change scores for any study outcomes. The power analysis was based on a study of krill oil for reducing CRP levels in persons with arthritis (N = 90) that yielded an effect size (Cohen’s d) of 1.2. A sample size of 37 was determined to yield a power of 0.80 to detect an effect size of 1.0 with a two-tailed alpha of 0.05.|The change scores of the two groups (week 12 minus baseline) were compared using Wilcoxon rank sum tests.
1630902|NCT02102464|2996180|Superiority||Mean Difference (Final Values)|3.9|||<|0.0001|2-Sided|95.0|2.5|5.4|||t-test, 2 sided||||
1630903|NCT02102464|2996181|Superiority||Mean Difference (Final Values)|-7.7|||<|0.0001|2-Sided|95.0|-10.2|-5.2|||t-test, 2 sided||||
1630904|NCT02102464|2996182|Superiority||Mean Difference (Final Values)|11.0|||<|0.0001|2-Sided|95.0|8.0|14.0|||t-test, 2 sided||||
1630905|NCT02102399|2996183|Superiority or Other|||||||0.107|||||||Fisher Exact||||
1630906|NCT02102399|2996184|Superiority or Other|||||||0.03|||||||Fisher Exact||||
1630907|NCT02102399|2996185|Superiority or Other|||||||0.12|||||||Fisher Exact||||
1630908|NCT02102399|2996186|Superiority or Other|||||||0.74|||||||Wilcoxon (Mann-Whitney)||||
1630909|NCT02102399|2996187|Superiority or Other|||||||0.49|||||||Wilcoxon (Mann-Whitney)||||
1630910|NCT02102399|2996188|Superiority or Other|||||||0.77|||||||Wilcoxon (Mann-Whitney)||||
1630911|NCT02102399|2996189|Superiority or Other|||||||0.2|||||||Wilcoxon (Mann-Whitney)||||
1630912|NCT02102399|2996190|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)||||
1630913|NCT02102399|2996191|Superiority or Other|||||||0.76|||||||Wilcoxon (Mann-Whitney)||||
1630914|NCT02102399|2996192|Superiority or Other|||||||0.959|||||||Wilcoxon's signed-rank test||||
1630915|NCT02102399|2996193|Superiority or Other|||||||0.776|||||||Wilcoxon's signed-rank test||||
1630916|NCT02102399|2996194|Superiority or Other|||||||0.296|||||||Wilcoxon's signed-rank test||||
1630917|NCT02102399|2996195|Superiority or Other|||||||0.323|||||||Wilcoxon's signed-rank test||||
1630918|NCT02102399|2996196|Superiority or Other|||||||0.049|||||||Wilcoxon's signed-rank test||||
1630919|NCT02102399|2996197|Superiority or Other|||||||0.007|||||||Wilcoxon's signed-rank test||||
1630920|NCT02102399|2996198|Superiority or Other|||||||0.477|||||||Wilcoxon's signed-rank test||||
1630921|NCT02102399|2996199|Superiority or Other|||||||0.451|||||||Wilcoxon's signed-rank test||||
1630922|NCT02102399|2996200|Superiority or Other|||||||0.022|||||||Wilcoxon's signed-rank test||||
1630923|NCT02102399|2996201|Superiority or Other|||||||0.171|||||||Wilcoxon's signed-rank test||||
1630924|NCT02102399|2996202|Superiority or Other|||||||0.003|||||||Fisher Exact||||
1630925|NCT02102399|2996203|Superiority or Other|||||||0.345|||||||Wilcoxon's signed-rank test||||
1630926|NCT02102399|2996204|Superiority or Other|||||||0.001|||||||Wilcoxon's signed-rank test||||
1630927|NCT02102100|2996215|Other||Mean Difference (Net)|0.9436|||<|0.0001|2-Sided||||||Mixed Models Analysis|||Least square means and standard errors were calculated to describe the patterns of means for each outcome. Effect slices were tested to explain significant interactions in the models. Pairwise comparisons of least square means were used to describe significant main effects.|
1630928|NCT02101515|2996229|Superiority or Other||Risk Ratio (RR)|0.3|||||2-Sided|95.0|0.03|2.77|||||||
1630929|NCT02101515|2996233|Superiority or Other|||||||0.6|||||||t-test, 2 sided||||
1630930|NCT02101515|2996235|Superiority or Other||Risk Ratio (RR)|0.76|||||2-Sided|95.0|0.39|1.49|||||||
1630931|NCT02101515|2996236|Superiority or Other||Risk Ratio (RR)|0.8|||||2-Sided|95.0|0.46|1.54|||||||
1630932|NCT02101515|2996238|Superiority or Other||Risk Ratio (RR)|5.41|||||2-Sided|95.0|0.68|42.9|||||||
1630933|NCT02101515|2996240|Superiority or Other||Risk Ratio (RR)|0.9|||||2-Sided|95.0|0.06|13.92|||||||
1630934|NCT02101515|2996241|Superiority or Other||Risk Ratio (RR)|2.71|||||2-Sided|95.0|1.3|5.62|||||||
1630935|NCT02101515|2996242|Superiority or Other||Risk Ratio (RR)|0.77|||||2-Sided|95.0|0.41|1.45|||||||
1630936|NCT02101515|2996243|Superiority or Other||Risk Ratio (RR)|2.41|||||2-Sided|95.0|0.67|8.4|||||||
1630937|NCT02101515|2996245|Superiority or Other||Risk Ratio (RR)|0.45|||||2-Sided|95.0|0.22|0.93|||||||
1631306|NCT02094898|2996922|Superiority||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.|
1630938|NCT02101411|2996247|Other|The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value < 5, then Fisher’s exact test was used.|Hazard Ratio (HR)|1.02|Standard Deviation|0.005||0.002|2-Sided|||||The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value < 5, then Fisher’s exact test was used.|Chi-squared|||The differences among the three PRU groups (<85, 85–208,>208) and ADEs were compared using the Chi-squared test.|
1630939|NCT02101411|2996247|Other|The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value < 5, then Fisher’s exact test was used.|Hazard Ratio (HR)|1.19|Standard Deviation|0.005||0.002|2-Sided|||||The Chi-squared test was used for comparisons of all categorical variables. If 20% of the cells had an expected value < 5, then Fisher’s exact test was used.|Chi-squared|The differences among the three PRU groups (<85, 85–208,>208) and ADEs were compared using the Chi-squared test.||The differences among the three PRU groups (<85, 85–208,>208) and MACE rate at 24 months were compared using the Chi-squared test. was recorded.|
1630940|NCT02101112|2996278|Superiority or Other||Ratio of Adjusted Geometric Means|0.832|||||2-Sided|90.0|0.794|0.871||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)|
1630941|NCT02101112|2996278|Superiority or Other||Ratio of Adjusted Geometric Means|1.027|||||2-Sided|90.0|0.981|1.075||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)|
1630942|NCT02101112|2996279|Superiority or Other||Ratio of Adjusted Geometric Means|0.835|||||2-Sided|90.0|0.797|0.875||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)|
1630943|NCT02101112|2996279|Superiority or Other||Ratio of Adjusted Geometric Means|1.027|||||2-Sided|90.0|0.981|1.076||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)|
1630944|NCT02101112|2996280|Superiority or Other||Ratio of Adjusted Geometric Means|0.788|||||2-Sided|90.0|0.741|0.839||||||Apixaban, 10 mg (crushed and mixed with applesauce) vs. Apixaban, 10 mg (whole tablets)|
1630945|NCT02101112|2996280|Superiority or Other||Ratio of Adjusted Geometric Means|1.054|||||2-Sided|90.0|0.994|1.118||||||Apixaban, 10 mg (crushed and suspended in water) vs. Apixaban, 10 mg (whole tablets)|
1630946|NCT02100969|2996291|Superiority||Median Difference (Net)|715.0||||0.0028|2-Sided||||||Wilcoxon Signed Rank for paired data||||
1630947|NCT02100969|2996292|Superiority||Median Difference (Net)|8.3||||0.289|2-Sided||||||Wilcoxon Signed Rank for paired data||||
1630948|NCT02100969|2996293|Superiority||Median Difference (Net)|4.2||||0.51|2-Sided||||||Wilcoxon Signed Rank for paired data||||
1630949|NCT02100969|2996294|Superiority||Median Difference (Net)|5.6||||0.901|2-Sided||||||Wilcoxon Signed Rank for paired data||||
1630950|NCT02100969|2996295|Superiority||Median Difference (Net)|2.0||||0.047|2-Sided||||||Wilcoxon Signed Rank for paired data||The value of the signed-rank test statistic is 53.||
1630951|NCT02100969|2996296|Superiority||Median Difference (Net)|6.0||||0.612|2-Sided||||||Wilcoxon Signed Rank for paired data||||
1630952|NCT02100969|2996297|Superiority||Median Difference (Net)|0.0||||0.113|2-Sided||||||Wilcoxon Signed Rank for paired data||The value of the signed rank test statistic is 44.50.||
1630953|NCT02100969|2996298|Superiority||"proportion of successes"|0.864||||0.0179|2-Sided|95.0|0.72|1.0||No adjustment is required as we are not doing multiple comparisons for the primary outcome analyses.|One sample Z test of proportions||One sample Z test of proportions is used. Method of handling missing data (as per protocol) is Last Observation Carried Forward (LOCF). Only 2 participants had missing values and in our case the LOCF results reflect a 'best-case' scenario.|"Sample size/power calculations are mentioned in the study protocol.~The study hypotheses are as follows:~H0: Proportion of patients whose QMG scores are increased by no more than 3 points at the end of the SCIg treatment phase ≤ 0.65 HA: Proportion of patients whose QMG scores are increased by no more than 3 points at the end of the SCIg treatment phase > 0.65"|
1630954|NCT02100813|2996308|Superiority or Other||Ratio of clearance rates|1.09|||=|0|2-Sided|95.0|0.81|1.49|||Log binomial regression||||
1630955|NCT02100813|2996308|Superiority or Other||Ratio of clearance rates|9.55|||<|0.001|2-Sided|95.0|3.22|56.4|||Log binomial regression||||
1630956|NCT02100813|2996308|Superiority or Other||Ratio of clearance rates|8.73|||<|0.001|2-Sided|95.0|2.93|51.66|||Log binomial regression||||
1630957|NCT02100813|2996309|Superiority or Other||Ratio of clearance rates|1.26|||=|0|2-Sided|95.0|0.72|2.31|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.|
1630958|NCT02100813|2996309|Superiority or Other||Ratio of clearance rates|8.82|||=|0|2-Sided|95.0|1.99|154.5|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.|
1630959|NCT02100813|2996309|Superiority or Other||Ratio of clearance rates|7.02|||=|0|2-Sided|95.0|1.53|124.0|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.|
1630960|NCT02100813|2996310|Superiority or Other||Rate ratio|0.79|||=|0|2-Sided|95.0|0.59|1.04|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.|
1630961|NCT02100813|2996310|Superiority or Other||Rate ratio|0.25|||<|0.001|2-Sided|95.0|0.18|0.33|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.|
1630962|NCT02100813|2996310|Superiority or Other||Rate ratio|0.31|||<|0.001|2-Sided|95.0|0.23|0.42|||Negative binomial regression|||Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.|
1630963|NCT02100670|2996313|Superiority or Other||Cox proportional hazard ratio|1.38||||0.315|2-Sided|95.0|0.73|2.61||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.||
1630964|NCT02100670|2996313|Superiority or Other||Cox proportional hazard ratio|1.31||||0.4507|2-Sided|95.0|0.65|2.65||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to complete pain relief. The 95% confidence intervals of cox proportional hazard ratio.||
1631240|NCT02095145|2996892|Other|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Tumor p-value|
1630968|NCT02100670|2996317|Superiority or Other||Cox proportional hazard ratio|1.06||||0.7003|2-Sided|95.0|0.79|1.43||P-value from chi-square test of survival analysis|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to cooling sensation. The 95% confidence intervals of cox proportional hazard ratio.||
1630969|NCT02100670|2996318|Superiority or Other||Cox proportional hazard ratio|1.0||||0.9817|2-Sided|95.0|0.74|1.37||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.||
1630970|NCT02100670|2996318|Superiority or Other||Cox proportional hazard ratio|1.23||||0.2389|2-Sided|95.0|0.87|1.73||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.||
1630971|NCT02100670|2996318|Superiority or Other||Cox proportional hazard ratio|0.93||||0.6918|2-Sided|95.0|0.67|1.31||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.||
1630972|NCT02100670|2996319|Superiority or Other||Cox proportional hazard ratio|1.09||||0.5118|2-Sided|95.0|0.84|1.43||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.||
1630973|NCT02100670|2996319|Superiority or Other||Cox proportional hazard ratio|0.9||||0.4639|2-Sided|95.0|0.67|1.2||P-value from chi-square test of survival analysis.|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.||
1630974|NCT02100670|2996319|Superiority or Other||Cox proportional hazard ratio|1.1||||0.5404|2-Sided|95.0|0.81|1.48||P-value from chi-square test of survival analysis|chi-square test of survival analysis||Cox proportional hazard ratio of survival time, i.e. time to reach perceptible pain relief. The 95% confidence intervals of cox proportional hazard ratio.||
1630975|NCT02100670|2996324|Superiority or Other||LS mean difference|-10.81||||0.3442|2-Sided|95.0|-33.26|11.64||P-value from multiple comparisons using t-test in Proc Mixed.|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.||
1630976|NCT02100670|2996324|Superiority or Other||LS mean difference|1.03||||0.9279|2-Sided|95.0|-21.27|23.33||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.||
1630977|NCT02100670|2996324|Superiority or Other||LS mean difference|2.61||||0.8164|2-Sided|95.0|-19.46|24.67||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.||
1630978|NCT02100670|2996324|Superiority or Other||LS mean difference|1.58||||0.8761|2-Sided|95.0|-18.34|21.5||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.||
1630979|NCT02100670|2996325|Superiority or Other||Difference of LS mean|-9.23||||0.4144|2-Sided|95.0|-31.45|12.98||P-value from multiple comparisons using t-test in Proc Mixed|ANCOVA|Least squares (LS) means from mixed model analysis of covariance with treatment, site as fixed effects, pain intensity at baseline as a covariates.|Difference of LS mean of first named treatment minus second named treatment. Lower values of LS mean favours a better response because of lower pain intensity over time. 95% Confidence intervals of difference between LS means.||
1630980|NCT02100514|2996342|Superiority or Other||Odds Ratio (OR)|43.3||||||95.0|19.52|96.13||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.|
1630981|NCT02100514|2996342|Superiority or Other||Odds Ratio (OR)|110.8||||||95.0|39.77|308.46||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.|
1630982|NCT02100514|2996342|Superiority or Other||Odds Ratio (OR)|156.4||||||95.0|48.84|501.11||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.|
1630983|NCT02100514|2996343|Superiority or Other||Odds Ratio (OR)|9.1||||||95.0|6.18|13.48||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.|
1630984|NCT02100514|2996343|Superiority or Other||Odds Ratio (OR)|17.0||||||95.0|11.15|26.07||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.|
1630985|NCT02100514|2996343|Superiority or Other||Odds Ratio (OR)|53.9||||||95.0|32.08|90.59||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.|
1631098|NCT02099786|2996427|Superiority||Odds Ratio (OR)|2.2||||0.27|2-Sided|95.0|0.55|8.8|||Regression, Logistic|||Null hypothesis: There is no difference in the number of participants with ASHA-significant threshold shifts between treatment arms.|
1630986|NCT02100514|2996344|Superiority or Other||LS mean difference compared to placebo|-0.3|Standard Error of the Mean|0.04||||95.0|-0.4|-0.2||||||Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1630987|NCT02100514|2996344|Superiority or Other||LS mean difference compared to placebo|-0.3|Standard Error of the Mean|0.02||||95.0|-0.3|-0.3||||||Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1630988|NCT02100514|2996344|Superiority or Other||LS mean difference compared to placebo|-0.4|Standard Error of the Mean|0.02||||95.0|-0.4|-0.3||||||Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1630989|NCT02100514|2996345|Superiority or Other||LS mean difference compared to placebo|-1.4|Standard Error of the Mean|0.12||||95.0|-1.6|-1.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1630990|NCT02100514|2996345|Superiority or Other||LS mean difference compared to placebo|-1.4|Standard Error of the Mean|0.1||||95.0|-1.6|-1.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1630991|NCT02100514|2996345|Superiority or Other||LS mean difference compared to placebo|-1.6|Standard Error of the Mean|0.08||||95.0|-1.8|-1.5||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1630992|NCT02100514|2996346|Superiority or Other||LS mean difference compared to placebo|2.6|Standard Error of the Mean|0.52||||95.0|1.6|3.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1630993|NCT02100514|2996347|Superiority or Other||LS mean difference compared to placebo|-10.4|Standard Error of the Mean|1.06||||95.0|-12.5|-8.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1630994|NCT02100514|2996348|Superiority or Other||LS mean difference compared to placebo|-47.7|Standard Error of the Mean|2.12||||95.0|-51.9|-43.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1630995|NCT02100514|2996349|Superiority or Other||LS mean difference compared to placebo|-71.3|Standard Error of the Mean|3.14||||95.0|-77.5|-65.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1630996|NCT02100514|2996350|Superiority or Other||LS mean difference compared to placebo|-69.1|Standard Error of the Mean|3.08||||95.0|-75.2|-63.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1630997|NCT02100514|2996351|Superiority or Other||LS mean difference compared to placebo|-66.5|Standard Error of the Mean|2.77||||95.0|-72.0|-61.1||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1630998|NCT02100514|2996352|Superiority or Other||LS mean difference compared to placebo|-66.1|Standard Error of the Mean|5.4||||95.0|-76.7|-55.4||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1630999|NCT02100514|2996353|Superiority or Other||LS mean difference compared to placebo|-66.8|Standard Error of the Mean|3.18||||95.0|-73.0|-60.5||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1631000|NCT02100514|2996354|Superiority or Other||LS mean difference compared to placebo|-8.2|Standard Error of the Mean|3.04||||95.0|-14.1|-2.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631001|NCT02100514|2996354|Superiority or Other||LS mean difference compared to placebo|-9.0|Standard Error of the Mean|4.5||||95.0|-17.9|-0.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631123|NCT02099110|2996460|Superiority or Other||Difference in % vs. Ertugliflozin 5 mg|0.1|||||2-Sided|95.0|-3.3|3.6|||||Based on Miettinen & Nurminen method.||
1631002|NCT02100514|2996354|Superiority or Other||LS mean difference compared to placebo|-10.1|Standard Error of the Mean|2.55||||95.0|-15.1|-5.1||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631003|NCT02100514|2996355|Superiority or Other||LS mean difference compared to placebo|0.8|Standard Error of the Mean|0.95||||95.0|-1.0|2.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631004|NCT02100514|2996355|Superiority or Other||LS mean difference compared to placebo|0.9|Standard Error of the Mean|1.04||||95.0|-1.1|3.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631005|NCT02100514|2996355|Superiority or Other||LS mean difference compared to placebo|1.1|Standard Error of the Mean|0.9||||95.0|-0.7|2.8||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631006|NCT02100514|2996356|Superiority or Other||LS mean difference compared to placebo|4.3|Standard Error of the Mean|0.97||||95.0|2.4|6.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631007|NCT02100514|2996356|Superiority or Other||LS mean difference compared to placebo|3.8|Standard Error of the Mean|0.86||||95.0|2.2|5.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631008|NCT02100514|2996356|Superiority or Other||LS mean difference compared to placebo|4.1|Standard Error of the Mean|0.85||||95.0|2.5|5.8||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631009|NCT02100514|2996357|Superiority or Other||LS mean difference compared to placebo|-8.2|Standard Error of the Mean|3.04||||95.0|-14.1|-2.2||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631010|NCT02100514|2996357|Superiority or Other||LS mean difference compared to placebo|-9.0|Standard Error of the Mean|4.5||||95.0|-17.9|-0.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631011|NCT02100514|2996357|Superiority or Other||LS mean difference compared to placebo|-10.1|Standard Error of the Mean|2.55||||95.0|-15.1|-5.1||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631012|NCT02100514|2996358|Superiority or Other||LS mean difference compared to placebo|-36.2|Standard Error of the Mean|2.42|||2-Sided|95.0|-40.9|-31.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631013|NCT02100514|2996358|Superiority or Other||LS mean difference compared to placebo|-44.2|Standard Error of the Mean|2.39||||95.0|-48.8|-39.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631014|NCT02100514|2996359|Superiority or Other||LS mean difference compared to placebo|6.0|Standard Error of the Mean|1.2||||95.0|3.6|8.3||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631015|NCT02100514|2996359|Superiority or Other||LS mean difference compared to placebo|5.4|Standard Error of the Mean|1.14||||95.0|3.2|7.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631016|NCT02100514|2996359|Superiority or Other||LS mean difference compared to placebo|5.5|Standard Error of the Mean|1.06|<|0.001|2-Sided|95.0|3.4|7.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631017|NCT02100514|2996360|Superiority or Other||LS mean difference compared to placebo|-49.4|Standard Error of the Mean|18.27|||2-Sided|95.0|-85.2|-13.5||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631018|NCT02100514|2996360|Superiority or Other||LS mean difference compared to placebo|-27.5|Standard Error of the Mean|3.23||||95.0|-33.9|-21.2||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631019|NCT02100514|2996360|Superiority or Other||LS mean difference compared to placebo|-30.8|Standard Error of the Mean|3.14|<|0.001||95.0|-36.9|-24.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631020|NCT02100514|2996361|Superiority or Other||LS mean difference compared to placebo|-33.4|Standard Error of the Mean|4.02||||95.0|-41.3|-25.5||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1631021|NCT02100514|2996361|Superiority or Other||LS mean difference compared to placebo|-39.7|Standard Error of the Mean|4.12||||95.0|-47.9|-31.6||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1631022|NCT02100514|2996361|Superiority or Other||LS mean difference compared to placebo|-46.6|Standard Error of the Mean|3.59|<|0.001||95.0|-53.7|-39.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1631023|NCT02100514|2996362|Superiority or Other||LS mean difference compared to placebo|-37.4|Standard Error of the Mean|3.03|||2-Sided|95.0|-43.3|-31.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1631024|NCT02100514|2996362|Superiority or Other||LS mean difference compared to placebo|-46.4|Standard Error of the Mean|2.94|||2-Sided|95.0|-52.2|-40.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1631025|NCT02100514|2996362|Superiority or Other||LS mean difference compared to placebo|-51.6|Standard Error of the Mean|2.59|<|0.001|2-Sided|95.0|-56.7|-46.6|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1631026|NCT02100514|2996363|Superiority or Other||LS mean difference compared to placebo|-32.7|Standard Error of the Mean|2.2|||2-Sided|95.0|-37.0|-28.4||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631027|NCT02100514|2996363|Superiority or Other||LS mean difference compared to placebo|-40.5|Standard Error of the Mean|2.21|||2-Sided|95.0|-44.8|-36.1||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631028|NCT02100514|2996363|Superiority or Other||LS mean difference compared to placebo|-45.0|Standard Error of the Mean|1.99|<|0.001|2-Sided|95.0|-48.9|-41.1|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631029|NCT02100514|2996364|Superiority or Other||LS mean difference compared to placebo|-32.5|Standard Error of the Mean|2.17|||2-Sided|95.0|-36.7|-28.2||||||Week 52: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631030|NCT02100514|2996364|Superiority or Other||LS mean difference compared to placebo|-40.9|Standard Error of the Mean|2.26|||2-Sided|95.0|-45.3|-36.5||||||Week 24: LS mean difference and associated 95% CI, were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631031|NCT02100514|2996364|Superiority or Other||LS mean difference compared to placebo|-45.7|Standard Error of the Mean|2.04|<|0.001|2-Sided|95.0|-49.7|-41.7|||MMRM|||Week 12: LS mean difference and associated 95% CI, and p-value were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631032|NCT02100514|2996365|Superiority or Other||LS mean difference compared to placebo|-23.8|Standard Error of the Mean|1.65|||2-Sided|95.0|-27.0|-20.5||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631033|NCT02100514|2996365|Superiority or Other||LS mean difference compared to placebo|-29.6|Standard Error of the Mean|1.66|||2-Sided|95.0|-32.8|-26.3||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631034|NCT02100514|2996365|Superiority or Other||LS mean difference compared to placebo|-33.2|Standard Error of the Mean|1.48|<|0.001|2-Sided|95.0|-36.1|-30.2|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631035|NCT02100514|2996366|Superiority or Other||LS mean difference compared to placebo|-49.9|Standard Error of the Mean|2.09|<|0.001|2-Sided|95.0|-54.0|-45.8|||MMRM|||Least square (LS) mean difference and associated 95% confidence interval (CI), and p-value were derived from an mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1631036|NCT02100475|2996369|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.427|2-Sided|95.0|-1.05|0.46|||ANCOVA|||The response and change from baseline in the response after 26 weeks of treatment was analysed using an analysis of covariance (ANCOVA) method with treatment and baseline IDegLira dose strata as fixed factors and baseline response as a covariate. Missing data were imputed using LOCF.|
1631037|NCT02100228|2996390|Superiority|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|1.9841|||>|0.9999|2-Sided|95.0|0.1866|53.9968||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher’s exact test for comparisons of two proportions.|
1631038|NCT02100228|2996391|Superiority|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.83||||0.6851|2-Sided|95.0|0.3433|1.8916||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher’s exact test for comparisons of two proportions.|
1631039|NCT02100228|2996392|Superiority|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.4905||||0.3378|2-Sided|95.0|0.1046|2.0678||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher’s exact test for comparisons of two proportions.|
1631040|NCT02100228|2996394|Superiority|This was a descriptive study, and there was no formal pre-defined hypothesis testing.|Risk Ratio (RR)|0.0||||0.0151|2-Sided|95.0|0.0|0.6425||nominal p-value|Fisher Exact|||Display exact confidence limits for relative risk and Fisher’s exact test for comparisons of two proportions.|
1631041|NCT02100189|2996397|Superiority or Other||Specificity|94.7|Standard Error of the Mean|0.051|||2-Sided|95.0|73.97|99.87|||||Exact binomial confidence interval||
1631042|NCT02100189|2996398|Superiority or Other||Sensitivity|13.3|Standard Error of the Mean|0.062|||2-Sided|95.0|3.76|30.72|||||Exact Binomial confidence interval.||
1631043|NCT02100124|2996399|Superiority||Odds Ratio (OR)|0.97||||1|2-Sided|95.0|0.75|1.25|||Regression, Logistic||||
1631044|NCT02100124|2996399|Superiority||Odds Ratio (OR)|1.04||||1|2-Sided|95.0|0.81|1.33|||Regression, Logistic||||
1631045|NCT02100124|2996399|Superiority||Odds Ratio (OR)|1.07||||1|2-Sided|95.0|0.83|1.37|||Regression, Logistic||||
1631046|NCT02100124|2996400|Superiority||Odds Ratio (OR)|0.98||||1|2-Sided|95.0|0.79|1.22|||Regression, Logistic||||
1631047|NCT02100124|2996400|Superiority||Odds Ratio (OR)|1.02||||1|2-Sided|95.0|0.82|1.26|||Regression, Logistic||||
1631048|NCT02100124|2996400|Superiority||Odds Ratio (OR)|1.04||||1|2-Sided|95.0|0.84|1.29|||Regression, Logistic||||
1631049|NCT02100124|2996401|Superiority||Odds Ratio (OR)|1.23||||0.07|2-Sided|95.0|0.99|1.53|||Regression, Logistic||||
1631050|NCT02100124|2996401|Superiority||Odds Ratio (OR)|1.08||||1|2-Sided|95.0|0.87|1.35|||Regression, Logistic||||
1631051|NCT02100124|2996401|Superiority||Odds Ratio (OR)|0.88||||0.48|2-Sided|95.0|0.71|1.09|||Regression, Logistic||||
1631052|NCT02100124|2996402|Superiority||Odds Ratio (OR)|1.3||||0.53|2-Sided|95.0|0.82|2.08|||Regression, Logistic||||
1631053|NCT02100124|2996402|Superiority||Odds Ratio (OR)|1.13||||1|2-Sided|95.0|0.7|1.83|||Regression, Logistic||||
1631054|NCT02100124|2996402|Superiority||Odds Ratio (OR)|0.87||||1|2-Sided|95.0|0.56|1.36|||Regression, Logistic||||
1631055|NCT02099838|2996411|Superiority or Other|||||||0.5015||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.|
1631056|NCT02099838|2996411|Superiority or Other|||||||0.0997||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.|
1631057|NCT02099838|2996411|Superiority or Other|||||||0.0339||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.|
1631058|NCT02099838|2996412|Superiority or Other|||||||0.6918||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TBil between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.|
1631059|NCT02099838|2996412|Superiority or Other|||||||0.7675||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TBil between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.|
1631060|NCT02099838|2996412|Superiority or Other|||||||0.8034||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of DBil between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.|
1631061|NCT02099838|2996413|Superiority or Other|||||||0.8744||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.|
1631062|NCT02099838|2996413|Superiority or Other|||||||0.7801||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.|
1631063|NCT02099838|2996413|Superiority or Other|||||||0.7972||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of AST between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.|
1631064|NCT02099838|2996414|Superiority or Other|||||||0.2589||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.|
1631065|NCT02099838|2996414|Superiority or Other|||||||0.3681||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.|
1631066|NCT02099838|2996414|Superiority or Other|||||||0.5636||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of ALT between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.|
1631067|NCT02099838|2996415|Superiority or Other|||||||0.362||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.|
1631068|NCT02099838|2996415|Superiority or Other|||||||0.1248||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.|
1631069|NCT02099838|2996415|Superiority or Other|||||||0.5476||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of LDL between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.|
1631070|NCT02099838|2996416|Superiority or Other|||||||0.0108||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.|
1631071|NCT02099838|2996416|Superiority or Other|||||||0.3812||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.|
1631072|NCT02099838|2996416|Superiority or Other|||||||0.0038||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HDL between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.|
1631073|NCT02099838|2996417|Superiority or Other|||||||0.3204||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.|
1631074|NCT02099838|2996417|Superiority or Other|||||||0.6963||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.|
1631075|NCT02099838|2996417|Superiority or Other|||||||0.3151||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.|
1631076|NCT02099838|2996418|Superiority or Other|||||||1||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.|
1631077|NCT02099838|2996418|Superiority or Other|||||||0.4236||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.|
1631078|NCT02099838|2996418|Superiority or Other|||||||0.3795||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of TC between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.|
1631079|NCT02099838|2996419|Superiority or Other|||||||0.0614||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.|
1631080|NCT02099838|2996419|Superiority or Other|||||||0.4006||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.|
1631081|NCT02099838|2996419|Superiority or Other|||||||0.1147||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2-hour postprandial insulin between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.|
1631082|NCT02099838|2996420|Superiority or Other|||||||0.0013||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.|
1631083|NCT02099838|2996420|Superiority or Other|||||||0.7353||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between before and after treatment in Placebo group.. The test was performed with a significance level of 0.05.|
1631084|NCT02099838|2996420|Superiority or Other||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of fasting insulin between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.|
1631085|NCT02099838|2996421|Superiority or Other|||||||0.0003||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.|
1631086|NCT02099838|2996421|Superiority or Other|||||||0.2428||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.|
1631087|NCT02099838|2996421|Superiority or Other||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of 2hPPG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.|
1631088|NCT02099838|2996422|Superiority or Other|||||||0.0005||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.|
1631089|NCT02099838|2996422|Superiority or Other|||||||0.0849||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.|
1631090|NCT02099838|2996422|Superiority or Other||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of FPG between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.|
1631091|NCT02099838|2996423|Superiority or Other|||||||0.0005||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between Pioglitazone and Metformin group and Placebo group. The test was performed with a significance level of 0.05.|
1631092|NCT02099838|2996423|Superiority or Other|||||||0.065||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between before and after treatment in Placebo group. The test was performed with a significance level of 0.05.|
1631093|NCT02099838|2996423|Superiority or Other||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05; the change was statistical significant with P-value less than 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis is that there was no difference in change of HbA1c between before and after treatment in Pioglitazone and Metformin group. The test was performed with a significance level of 0.05.|
1631094|NCT02099786|2996424|Superiority|||||||0.72||||||The a priori threshold for statistical significance is .05|t-test, 2 sided||||
1631095|NCT02099786|2996425|Non-Inferiority|We require a non-inferiority margin of no more than 1.1 mortality odds among COMP-VA patients relative to Usual Care patients. This means that the upper 95% confidence bound for the fitted odds ratio must be less than 1.1 to reject the null hypothesis that COMP-VA induces extra mortality risk.|Odds Ratio (OR)|1.9|||||1-Sided||||||||||
1631096|NCT02099786|2996426|Superiority||Odds Ratio (OR)|0.92||||0.88|2-Sided|95.0|0.29|2.9|||Regression, Logistic|||Null hypothesis is no difference in audiology clinic use between treatment arms.|
1631097|NCT02099786|2996427|Superiority||Odds Ratio (OR)|1.4||||0.67|2-Sided|95.0|0.3|5.9|||Regression, Logistic|||Null hypothesis: There is no difference in the number of participants with CTCAE grade 1 or greater hearing loss between treatment arms.|
1631124|NCT02099110|2996461|Superiority or Other||Difference in % vs. Sitagliptin 100 mg|-1.8|||||2-Sided|95.0|-10.5|7.0|||||Based on Miettinen & Nurminen method.||
1631099|NCT02099461|2996444|Superiority or Other||LS Mean Difference|-0.24||||0.2345|2-Sided|95.0|-0.646|0.161|||ANCOVA||Denosumab 120 mg - Placebo|An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.|
1631100|NCT02099461|2996444|Superiority or Other||LS Mean Difference|-0.31||||0.1343|2-Sided|95.0|-0.72|0.098|||ANCOVA||Denosumab 60 mg - Placebo|An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.|
1631101|NCT02099461|2996444|Superiority or Other||LS Mean|-0.09||||0.5238|2-Sided|95.0|-0.373|0.191|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.|
1631102|NCT02099461|2996444|Superiority or Other||LS Mean|-0.16||||0.2769|2-Sided|95.0|-0.447|0.13|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.|
1631103|NCT02099461|2996444|Superiority or Other||LS Mean|0.15||||0.2966|2-Sided|95.0|-0.136|0.441|||ANCOVA|||An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.|
1631104|NCT02099110|2996455|Superiority or Other||Difference in the least squares means|-3.01||||0.002|2-Sided|95.0|-4.94|-1.09||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1631105|NCT02099110|2996455|Superiority or Other||Difference in the least squares means|-2.76||||0.005|2-Sided|95.0|-4.69|-0.83||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1631106|NCT02099110|2996456|Superiority or Other||Difference in the least squares means|-9.59||||0.075|2-Sided|95.0|-20.17|0.98||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Difference in the least squares means||||
1631107|NCT02099110|2996456|Superiority or Other||Difference in the least squares means|1.81||||0.734|2-Sided|95.0|-8.66|12.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1631108|NCT02099110|2996456|Superiority or Other||Difference in the least squares means|-4.87||||0.369|2-Sided|95.0|-15.54|5.8||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1631109|NCT02099110|2996456|Superiority or Other||Difference in the least squares means|7.61||||0.155|2-Sided|95.0|-2.9|18.13||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1631110|NCT02099110|2996457|Superiority or Other||Odds Ratio (OR)|2.56|||<|0.001|2-Sided|95.0|1.69|3.89|||Regression, Logistic|Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|||
1631111|NCT02099110|2996457|Superiority or Other||Odds Ratio (OR)|2.95|||<|0.001|2-Sided|95.0|1.92|4.54||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic||||
1631112|NCT02099110|2996457|Superiority or Other||Odds Ratio (OR)|2.53|||<|0.001|2-Sided|95.0|1.68|3.83||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic||||
1631113|NCT02099110|2996457|Superiority or Other||Odds Ratio (OR)|4.14|||<|0.001|2-Sided|95.0|2.68|6.4||Adjusted Odds Ratio using a logistic regression model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR.|Regression, Logistic||||
1631114|NCT02099110|2996458|Superiority or Other||Difference in the least squares means|-23.14|||<|0.001|2-Sided|95.0|-28.76|-17.53||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA||||
1631115|NCT02099110|2996458|Superiority or Other||Difference in the least squares means|-18.4|||<|0.001|2-Sided|95.0|-24.03|-12.77||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA||||
1631116|NCT02099110|2996458|Superiority or Other||Difference in the least squares means|-11.79|||<|0.001|2-Sided|95.0|-17.35|-6.23||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA||||
1631117|NCT02099110|2996458|Superiority or Other||Difference in the least squares means|-8.23|||<|0.004|2-Sided|95.0|-13.82|-2.65||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|cLDA||||
1631118|NCT02099110|2996459|Superiority or Other||Difference in the least squares means|-2.27|||<|0.001|2-Sided|95.0|-2.9|-1.64||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained logitudinal data analysis||||
1631119|NCT02099110|2996459|Superiority or Other||Difference in the least squares means|-1.85|||<|0.001|2-Sided|95.0|-2.48|-1.22||cLDA model including fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1631120|NCT02099110|2996460|Superiority or Other||Difference in % vs. Sitagliptin 100 mg|0.9|||||2-Sided|95.0|-2.5|4.4|||||Based on Miettinen & Nurminen method.||
1631121|NCT02099110|2996460|Superiority or Other||Difference in % vs. Sitagliptin 100 mg|0.5|||||2-Sided|95.0|-2.9|3.9|||||Based on Miettinen & Nurminen method.||
1631122|NCT02099110|2996460|Superiority or Other||Difference in % vs. Ertugliflozin 15 mg|0.5|||||2-Sided|95.0|-3.0|4.0|||||Based on Miettinen & Nurminen method.||
1631126|NCT02099110|2996461|Superiority or Other||Difference in % vs. Ertugliflozin 15 mg|-1.9|||||2-Sided|95.0|-10.6|6.8|||||Based on Miettinen & Nurminen method.||
1631127|NCT02099110|2996461|Superiority or Other||Difference in % vs Ertugliflozin 5 mg|-3.2|||||2-Sided|95.0|-11.7|5.5|||||Based on Miettinen & Nurminen method.||
1631128|NCT02099110|2996462|Superiority or Other||Difference in the least squares means|-0.47|||<|0.001|2-Sided|95.0|-0.63|-0.3||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1631129|NCT02099110|2996462|Superiority or Other||Difference in the least squares means|-0.44|||<|0.001|2-Sided|95.0|-0.61|-0.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1631130|NCT02099110|2996462|Superiority or Other||Difference in the least squares means|-0.43|||<|0.001|2-Sided|95.0|-0.6|-0.27||cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1631131|NCT02099110|2996462|Superiority or Other||Difference in the least squares means|-0.46|||<|0.001|2-Sided|95.0|-0.63|-0.3||Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1631132|NCT02099084|2996463|Superiority or Other|||||||0.34|||||||t-test, 2 sided|||Level of significance = .05|
1631133|NCT02099084|2996464|Superiority or Other|||||||0.42|||||||t-test, 2 sided|||Level of significance = .05|
1631134|NCT02099084|2996467|Superiority or Other|||||||0.075|||||||t-test, 2 sided|||Level of significance = .05|
1631135|NCT02099084|2996468|Superiority or Other|||||||0.17|||||||t-test, 2 sided|||Comparison between the groups for change between 0- and 8-hours. Level of significance = .05|
1631136|NCT02099084|2996468|Superiority or Other|||||||0.2|||||||t-test, 2 sided|||Comparison between the groups for change between 0- and 2-hours. Level of significance = .05|
1631137|NCT02099084|2996469|Superiority or Other|||||||0.74|||||||t-test, 2 sided|||Level of significance = .05|
1631138|NCT02099006|2996470|Superiority or Other|||||||0.79|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of amitriptyline/baclofen cream than with the daily application of a placebo cream.|
1631139|NCT02099006|2996470|Superiority or Other|||||||0.42|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketoprofen cream than with the daily application of a placebo cream.|
1631140|NCT02099006|2996470|Superiority or Other|||||||0.66|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of gabapentin cream than with the daily application of a placebo cream.|
1631141|NCT02099006|2996470|Superiority or Other|||||||1|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of ketamine cream than with the daily application of a placebo cream.|
1631142|NCT02099006|2996470|Superiority or Other|||||||0.31|||||||t-test, 2 sided|paired||Null hypothesis - that the improvement in tampon test pain would be no different with the daily application of loperamide cream than with the daily application of a placebo cream.|
1631143|NCT02099006|2996471|Superiority or Other|||||||1|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketoprofen than with the daily application of a placebo cream.|
1631144|NCT02099006|2996471|Superiority or Other|||||||0.25|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of amitriptyline and baclofen than with the daily application of a placebo cream.|
1631145|NCT02099006|2996471|Superiority or Other|||||||0.65|||||||t-test, 2 sided|paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of gabapentin than with the daily application of a placebo cream.|
1631146|NCT02099006|2996471|Superiority or Other|||||||0.33|||||||t-test, 2 sided|Paired||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of ketamine than with the daily application of a placebo cream.|
1631147|NCT02099006|2996471|Superiority or Other|||||||0.3|||||||t-test, 2 sided|Paired T test||Null hypothesis - that the improvement in daily genital pain would be no different with the daily application of loperamide than with the daily application of a placebo cream.|
1631148|NCT02098395|2996496|Superiority or Other||Mean Difference (Final Values)|-0.24|||=|0|2-Sided|95.0|-0.39|-0.1|||Mixed Models Analysis|||Superiority of liraglutide 0.6 mg versus placebo was planned to be evaluated only if superiority of liraglutide 1.2 mg was concluded.|
1631149|NCT02098395|2996496|Superiority or Other||Mean Difference (Final Values)|-0.23|||=|0|2-Sided|95.0|-0.38|-0.08|||Mixed Models Analysis|||Superiority of liraglutide 1.2 mg was planned to be evaluated only if superiority for liraglutide 1.8 mg was concluded.|
1631150|NCT02098395|2996496|Superiority or Other||Mean Difference (Final Values)|-0.35|||<|0.0001|2-Sided|95.0|-0.5|-0.2|||Mixed Models Analysis|||Superiority of liraglutide 1.8 mg versus placebo was planned to be concluded if and only if the upper limit of the two-sided 95% confidence interval for the estimated difference in HbA1c was less than zero.|
1631151|NCT02098304|2996508|Superiority or Other||Cohen's kappa|0.45||||0.001|2-Sided|95.0|0.24|0.66|||Cohen's Kappa||Cohen's kappa is a chance-adjusted measure of agreement. A value of 0 indicates agreement by chance and 1 perfect agreement.|The null hypothesis was of chance agreement (Cohen's kappa of 0) and was tested against a two-sided alternative at the 5% level of significance. The study was powered such that 58 teeth (29 subjects), there would be 95% power to reject the null hypothesis of chance agreement (Cohen’s kappa of 0) at the 5% level of significance, given that it was expected to be at least 0.4.|
1631152|NCT02098304|2996508|Superiority or Other||Percentage agreement|72.3|||<|0.001|2-Sided|95.0|59.8|82.7|||Exact binomial test|An exact binomial test was used and an exact 95% Confidence Interval using the Clopper-Pearson method was calculated.||The null hypothesis was of chance agreement (50%) and was tested against a two-sided alternative at the 5% level of significance.|
1631153|NCT02097849|2996527|Superiority or Other||Difference in proportions|-0.01||||0.955|2-Sided|95.0|-0.24|0.22|||Clopper-Pearson Exact||||
1631154|NCT02097849|2996528|Superiority or Other||Difference in proportions|0.0||||0.967|2-Sided|95.0|-0.24|0.23|||Clopper-Pearson Exact||||
1631155|NCT02097849|2996529|Superiority or Other||Difference in proportions|-0.03||||0.714|2-Sided|95.0|-0.26|0.2|||Clopper-Pearson Exact||||
1631156|NCT02097849|2996530|Superiority or Other||Difference in proportions|0.07||||0.3|2-Sided|95.0|-0.16|0.3|||Clopper-Pearson Exact||||
1631157|NCT02097849|2996531|Superiority or Other||Difference in proportions|-0.22||||0.057|2-Sided|95.0|-0.44|0.01|||Clopper-Pearson Exact||||
1631158|NCT02097849|2996532|Superiority or Other||Difference in proportions|-0.13||||0.225|2-Sided|95.0|-0.35|0.1|||Clopper-Pearson Exact||||
1631159|NCT02097849|2996533|Superiority or Other||Difference in proportion|-0.19||||0.12|2-Sided|95.0|-0.41|0.05|||Clopper-Pearson Exact|||Responders at Day 28|
1631160|NCT02097849|2996534|Superiority or Other||Difference in proportion|-0.04||||0.692|2-Sided|95.0|-0.27|0.19|||Clopper-Pearson Exact||||
1631161|NCT02097303|2996644|Other|||||||0.487||||||Comparison of PSA levels before and after treatment|t-test, 2 sided||||
1631162|NCT02097303|2996644|Other||||||<|1e-05||||||Comparison of ALP levels before and after treatment|t-test, 2 sided||||
1631163|NCT02096835|2996722|Superiority or Other|||||||0.571|||||||Chi-squared||||
1631164|NCT02096835|2996723|Superiority or Other|||||||0.503|||||||Chi-squared||||
1631165|NCT02096835|2996724|Superiority or Other|||||||0.021|||||||Chi-squared||||
1631166|NCT02096835|2996725|Superiority or Other|||||||0.021|||||||Chi-squared||||
1631167|NCT02096744|2996726|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|104.04|Standard Error of the Mean|16.7|<|0.0001|2-Sided|90.0|98.148|110.294|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group',‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."||
1631168|NCT02096744|2996727|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|102.78|Standard Error of the Mean|15.8|<|0.0001|2-Sided|90.0|97.25|108.63|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."||
1631169|NCT02096744|2996728|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|104.25|Standard Error of the Mean|16.6|<|0.0001|2-Sided|90.0|98.367|110.487|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."||
1631170|NCT02096744|2996729|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means Catapres-TTS-3(Oppanol/Vistanex) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|102.33|Standard Error of the Mean|19.0|<|0.0001|2-Sided|90.0|95.74|109.37|||ANOVA|ANOVA on the logarithmic scale including effects for 'Group', ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|"The estimated value is actually the ratio of Catapres-TTS-3 with Oppanol and Catapres-TTS-3 with Vistanex.~The value in parameter dispersion type and dispersion value is actually the intra-individual gCV."||
1631171|NCT02096731|2996730|Superiority or Other||Hazard Ratio (HR)|1.35|||||2-Sided|95.0|1.23|1.5|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."||
1631172|NCT02096731|2996731|Superiority or Other||Hazard Ratio (HR)|1.05|||||2-Sided|95.0|0.81|1.36|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."||
1631173|NCT02096731|2996732|Superiority or Other||Hazard Ratio (HR)|1.16|||||2-Sided|95.0|1.03|1.3|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."||
1631174|NCT02096731|2996733|Superiority or Other||Hazard Ratio (HR)|0.87|||||2-Sided|95.0|0.69|1.1|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."||
1631175|NCT02096731|2996734|Superiority or Other||Hazard Ratio (HR)|1.12|||||2-Sided|95.0|0.92|1.37|||||"HR adjusted for 10 year age groups, sex, calendar year of cohort entry, the decile of propensity score, ipratropium use prior to cohort entry and time since entry into base cohort.~Ratio calculated as combination therapy divided by monotherapy."||
1631176|NCT02096718|2996735|Superiority or Other||Ratio of gmeans|150.08|Standard Deviation|41.5|||2-Sided|90.0|105.626|213.25|||||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.|
1631177|NCT02096718|2996735|Superiority or Other||Ratio of gmeans|122.44|Standard Deviation|28.0|||2-Sided|90.0|96.141|155.928|||||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.|
1631178|NCT02096718|2996736|Superiority or Other||Ratio of gmeans|121.71|Standard Deviation|34.2|||2-Sided|90.0|90.79|163.162|||||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.|
1631179|NCT02096718|2996736|Superiority or Other||Ratio of gmeans|101.16|Standard Deviation|38.5|||2-Sided|90.0|72.931|140.309|||||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.|
1631180|NCT02096718|2996737|Superiority or Other||Ratio of gmeans|149.97|Standard Deviation|41.9|||2-Sided|90.0|105.266|213.671|||||Relative bioavailability comparison of afatinib for severe vs. normal matched with severe patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.|
1631181|NCT02096718|2996737|Superiority or Other||Ratio of gmeans|122.23|Standard Deviation|28.3|||2-Sided|90.0|95.743|156.045|||||Relative bioavailability comparison of afatinib for moderate vs. normal matched with moderate patients was estimated by the ratios of the geometric means (gMean). Standard deviation is actually Inter individual geometric coefficient variation (gCV).|The ANOVA model was fitted using log-transformed values. The difference between the expected means of each comparison was estimated by the difference in the corresponding Least Square Means (point estimate), and 2-sided 90% confidence intervals based on the t-distribution. These quantities were then back-transformed to the original scale to give the point estimator (gMean), and interval estimates for the intersubject ratio of the gMeans for each renal function group.|
1631182|NCT02096705|2996738|Superiority or Other||Mean Difference (Final Values)|-1.43|Standard Error of the Mean|0.5171||0.0059|2-Sided|95.0|-2.45|-0.42||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo||
1631183|NCT02096705|2996739|Superiority or Other||Mean Difference (Final Values)|-1.38|Standard Error of the Mean|0.3057|<|0.0001|2-Sided|95.0|-1.98|-0.77||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo||
1631184|NCT02096705|2996740|Superiority or Other||Mean Difference (Final Values)|-30.69|Standard Error of the Mean|4.605|<|0.0001|2-Sided|95.0|-39.76|-21.61|||Longitudinal repeated measure analysis|P-value for Dapagliflozin vs. placebo|Difference of Dapagliflozin from placebo||
1631185|NCT02096705|2996741|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.0968|<|0.0001|2-Sided|95.0|-1.09|-0.71||P-value for Dapagliflozin vs. placebo|Longitudinal repeated measure analysis||Difference of Dapagliflozin from placebo||
1631186|NCT02096471|2996775|Superiority|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-1.07|Standard Error of the Mean|7.53||0.89|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631187|NCT02096471|2996775|Superiority|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-0.71|Standard Error of the Mean|8.52||0.93|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631188|NCT02096471|2996775|Superiority|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-6.27|Standard Error of the Mean|5.72||0.28|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631189|NCT02096471|2996775|Superiority|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-4.21|Standard Error of the Mean|5.51||0.45|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631190|NCT02096471|2996775|Superiority|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-3.74|Standard Error of the Mean|6.58||0.57|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631191|NCT02096471|2996775|Superiority|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-10.97|Standard Error of the Mean|8.16||0.19|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631192|NCT02096471|2996775|Superiority|Single Group Study. change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|0.68|Standard Error of the Mean|7.99||0.93|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631193|NCT02096471|2996775|Superiority|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-0.17|Standard Error of the Mean|6.37||0.98|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631194|NCT02096471|2996775|Superiority|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-6.24|Standard Error of the Mean|6.74||0.36|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631195|NCT02096471|2996775|Superiority|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-2.34|Standard Error of the Mean|6.46||0.72|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631196|NCT02096471|2996775|Superiority|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|6.66|Standard Error of the Mean|5.05||0.19|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631197|NCT02096471|2996775|Superiority|Single Group Study. Change in Quality of Life from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|-12.98|Standard Error of the Mean|6.35||0.05|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only.||Single Group Change from Baseline|
1631198|NCT02096471|2996775|Superiority|Single Group Study Change in Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-13.06|Standard Error of the Mean|8.29||0.12|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631199|NCT02096471|2996775|Superiority|Single Group Study Change in Quality of Life from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-3.55|Standard Error of the Mean|6.87||0.61|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631200|NCT02096471|2996775|Superiority|Single Group Study. Change in Quality of Life (QOL) from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|-3.77|Standard Error of the Mean|3.6||0.3|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631201|NCT02096471|2996775|Superiority|Single Group Study. Change in Pain from Baseline amongst those with a Tumor Response|Mean Difference (Final Values)|0.89|Standard Error of the Mean|0.66||0.18|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631202|NCT02096471|2996775|Superiority|Single Group Study. Change in Pain from Baseline amongst those with a Tumor Response.|Mean Difference (Final Values)|2.1|Standard Error of the Mean|0.8||0.01|2-Sided||||||t-test, 2 sided|Descriptive Analysis Only||Single Group Change from Baseline|
1631203|NCT02096471|2996775|Superiority|Single group study. Change in Pain from Baseline amongst those with a tumor response|Mean Difference (Final Values)|1.38|Standard Error of the Mean|0.84||0.11|2-Sided||||||t-test, 2 sided|Descriptive analysis only||Single group change from baseline|
1631204|NCT02096263|2996824|Non-Inferiority|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio [Pediarix Group divided by Infanrix hexa Group] is ≤ 1.5.|Adjusted GMC ratio|0.79|||||2-Sided|95.0|0.63|0.99|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Tdap vaccination history of the mother during pregnancy as continuous regressor.).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertactin (PRN), one month after the third dose of the primary vaccination.|
1631205|NCT02096263|2996824|Non-Inferiority|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio [Pediarix Group divided by Infanrix hexa Group] is ≤ 1.5.|Adjusted GMC ratio|1.14|||||2-Sided|95.0|0.97|1.35|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, filamentous hemagglutinin (FHA), one month after the third dose of the primary vaccination.|
1631206|NCT02096263|2996824|Non-Inferiority|Non-inferiority in terms of immune response to pertussis antigens will be demonstrated if, for each of the three antigens, the upper limit of the 95% confidence interval (CI) on the GMC ratio [Pediarix Group divided by Infanrix hexa Group] is ≤ 1.5.|Adjusted GMC ratio|1.1|||||2-Sided|95.0|0.92|1.31|||||Adjusted GMC (ANCOVA model adjusted with the vaccine group as fixed effect and the Infanrix vaccination history of the mother during pregnancy as continuous regressor).|To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigen, pertussis toxoid (PT), one month after the third dose of the primary vaccination.|
1631207|NCT02096081|2996837|Non-Inferiority or Equivalence|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 4 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-1.9|||||2-Sided|95.0|-14.4|10.7|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.|
1631208|NCT02096081|2996838|Non-Inferiority or Equivalence|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 3 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-1.5|||||2-Sided|95.0|-12.4|9.5|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.|
1631241|NCT02095145|2996892|Other|||||||0.27|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Adjacent p-value|
1631242|NCT02095145|2996892|Other|||||||0.425|||||||Wilcoxon rank-sum test|||Change from Baseline: Cell Benign p-value|
1631243|NCT02095145|2996892|Other|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Tumor p-value|
1631244|NCT02095145|2996892|Other|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: Cyt Adjacent p-value|
1631209|NCT02096081|2996839|Non-Inferiority or Equivalence|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 2 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-2.8|||||2-Sided|95.0|-11.0|5.3|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.|
1631210|NCT02096081|2996840|Non-Inferiority or Equivalence|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 1 month was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-2.7|||||2-Sided|95.0|-8.5|3.2|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.|
1631211|NCT02096081|2996841|Non-Inferiority or Equivalence|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 4 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-5.2|||||2-Sided|95.0|-17.4|7.1|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.|
1631212|NCT02096081|2996842|Non-Inferiority or Equivalence|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 3 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-0.5|||||2-Sided|95.0|-10.6|9.6|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.|
1631213|NCT02096081|2996843|Non-Inferiority or Equivalence|This secondary analysis was performed for exploratory purposes. The analysis of response defined as the difference (D) in response rates between two treatment groups at 2 months was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group.|Difference in proportion of responders|-5.3|||||2-Sided|95.0|-12.1|1.5|||||If the confidence interval lies within the limits of ±0.15, then both incobotulinumtoxinA and onabotulinumtoxinA have similar efficacy profiles.|The study was not powered for this secondary endpoint.|
1631214|NCT02096081|2996844|Non-Inferiority or Equivalence|"The analysis of response defined as the difference (D) in response rates between two treatment groups at 1 month was as follows: D = response rate in the incobotulinumtoxinA group minus the response rate in the onabotulinumtoxinA group. The hypothesis testing procedure to test the equivalence of the two products is as follows:~Ho (null): D ≤ -∆ OR D ≥ ∆ versus Ha (alternate): -∆ < D < ∆, where ∆ is the margin of equivalence = 0.15."|Difference in proportions of response|-3.5|||||2-Sided|95.0|-7.5|0.6|||||If the confidence interval lies within the limits of ±0.15, then Ho is rejected in favor of Ha (i.e., equivalence of incobotulinumtoxinA and onabotulinumtoxinA can be concluded); otherwise, treatment equivalence cannot be concluded.|With assumptions of an alpha of 5%, an equivalence margin of 15% for each side, the real response rate expected as 90% for incobotulinumtoxinA and onabotulinumtoxinA at day 30 and a 1:1 allocation ratio, a total of 225 subjects were needed to achieve a statistical power of 90% in order to make an equivalence conclusion at day 30. Results are based on the Newcombe-Wilson confidence interval. To account for exclusions from the PPS of about 10%, approximately 250 subjects were enrolled.|
1631215|NCT02095197|2996880|Superiority or Other|||||||0.41|||||||Chi-squared||||
1631216|NCT02095197|2996881|Superiority or Other|||||||0.3|||||||Chi-squared||||
1631217|NCT02095197|2996882|Superiority or Other|||||||0.47|||||||Chi-squared||||
1631218|NCT02095197|2996883|Superiority or Other|||||||0.23|||||||Fisher Exact||||
1631219|NCT02095145|2996886|Other|||||||0.231|||||||Wilcoxon rank-sum test|||Change in Tumor Volume from baseline to end of study per arm|
1631220|NCT02095145|2996888|Other|||||||0.536|||||||Wilcoxon rank-sum test|||Change from Baseline Week 52|
1631221|NCT02095145|2996888|Other|||||||0.62|||||||Wilcoxon rank-sum test|||Change from Baseline Week 39|
1631222|NCT02095145|2996888|Other|||||||0.18|||||||Wilcoxon rank-sum test|||Change from Baseline Week 26|
1631223|NCT02095145|2996888|Other|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline Week 13|
1631224|NCT02095145|2996889|Other||||||<|0.001|||||||Wilcoxon rank-sum test|||Change from Baseline Week 52|
1631225|NCT02095145|2996889|Other||||||<|0.002|||||||Wilcoxon rank-sum test|||Change from Baseline Week 39|
1631226|NCT02095145|2996889|Other||||||<|0.004|||||||Wilcoxon rank-sum test|||Change from Baseline Week 26|
1631227|NCT02095145|2996889|Other||||||<|0.068|||||||Wilcoxon rank-sum test|||Change from Baseline Week 13|
1631228|NCT02095145|2996890|Other|||||||0.111|||||||Wilcoxon rank-sum test|||Change from Baseline: Tumor p-value|
1631229|NCT02095145|2996890|Other|||||||0.037|||||||Wilcoxon rank-sum test|||Change from Baseline: Adjacent p-value|
1631230|NCT02095145|2996890|Other|||||||0.143|||||||Wilcoxon rank-sum test|||Change from Baseline: Benign p-value|
1631231|NCT02095145|2996891|Other|||||||0.013|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value|
1631232|NCT02095145|2996891|Other|||||||0.066|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value|
1631233|NCT02095145|2996891|Other|||||||0.129|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value|
1631234|NCT02095145|2996891|Other|||||||0.005|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value|
1631235|NCT02095145|2996891|Other|||||||0.066|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value|
1631236|NCT02095145|2996891|Other|||||||0.105|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value|
1631237|NCT02095145|2996891|Other|||||||0.045|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value|
1631238|NCT02095145|2996891|Other|||||||0.128|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value|
1631248|NCT02095145|2996892|Other|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Nuc Benign p-value|
1631249|NCT02095145|2996893|Other|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: Tumor p-value|
1631250|NCT02095145|2996893|Other|||||||1|||||||Wilcoxon rank-sum test|||Change from Baseline: Adjacent p-value|
1631251|NCT02095145|2996893|Other|||||||0.865|||||||Wilcoxon rank-sum test|||Change from Baseline: Benign p-value|
1631252|NCT02095145|2996894|Other|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value|
1631253|NCT02095145|2996894|Other|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value|
1631254|NCT02095145|2996894|Other|||||||0.344|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value|
1631255|NCT02095145|2996894|Other|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value|
1631256|NCT02095145|2996894|Other|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value|
1631257|NCT02095145|2996894|Other|||||||0.452|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value|
1631258|NCT02095145|2996894|Other|||||||0.713|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value|
1631259|NCT02095145|2996894|Other|||||||0.391|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value|
1631260|NCT02095145|2996894|Other|||||||0.167|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value|
1631261|NCT02095145|2996895|Other|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Tumor p-value|
1631262|NCT02095145|2996895|Other|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Adjacent p-value|
1631263|NCT02095145|2996895|Other|||||||0.234|||||||Wilcoxon rank-sum test|||Change From Baseline: Cell Benign p-value|
1631264|NCT02095145|2996895|Other|||||||0.074|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Tumor p-value|
1631265|NCT02095145|2996895|Other|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Adjacent p-value|
1631266|NCT02095145|2996895|Other|||||||0.198|||||||Wilcoxon rank-sum test|||Change From Baseline: Cyt Benign p-value|
1631267|NCT02095145|2996895|Other|||||||0.371|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Tumor p-value|
1631268|NCT02095145|2996895|Other|||||||0.233|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Adjacent p-value|
1631269|NCT02095145|2996895|Other|||||||0.297|||||||Wilcoxon rank-sum test|||Change From Baseline: Nuc Benign p-value|
1631270|NCT02095145|2996896|Other|||||||0.128|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Cell)|
1631271|NCT02095145|2996896|Other|||||||0.128|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Cell)|
1631272|NCT02095145|2996896|Other|||||||0.247|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Cell)|
1631273|NCT02095145|2996896|Other|||||||0.066|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Cyt)|
1631274|NCT02095145|2996896|Other|||||||0.093|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Cyt)|
1631275|NCT02095145|2996896|Other|||||||0.247|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Cyt)|
1631276|NCT02095145|2996896|Other|||||||0.298|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Tumor (Nuc)|
1631277|NCT02095145|2996896|Other|||||||0.23|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Adjacent (Nuc)|
1631278|NCT02095145|2996896|Other|||||||0.304|||||||Wilcoxon rank-sum test|||Change from Baseline: IGF-1 Benign (Nuc)|
1631279|NCT02095145|2996897|Other|||||||0.766|||||||Wilcoxon rank-sum test|||Tumor core p-value|
1631280|NCT02095145|2996897|Other|||||||0.371|||||||Wilcoxon rank-sum test|||Adjacent core p-value|
1631281|NCT02095145|2996897|Other|||||||0.344|||||||Wilcoxon rank-sum test|||Benign core p-value|
1631282|NCT02095145|2996898|Other|||||||0.58|||||||Wilcoxon rank-sum test||||
1631283|NCT02095145|2996899|Other|||||||0.948|||||||Wilcoxon rank-sum test|||comparison of both arms at end of study, week 52|
1631284|NCT02095145|2996899|Other|||||||0.647|||||||Wilcoxon rank-sum test|||comparison of both arms at Week 26|
1631285|NCT02095145|2996899|Other|||||||0.556|||||||Wilcoxon rank-sum test|||Comparison of both arms at baseline|
1631286|NCT02095145|2996900|Other|||||||0.81|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 52|
1631287|NCT02095145|2996900|Other|||||||0.879|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 39|
1631288|NCT02095145|2996900|Other|||||||0.527|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 26|
1631289|NCT02095145|2996900|Other|||||||0.743|||||||Wilcoxon rank-sum test|||Change from Baseline PSA to Week 13|
1631290|NCT02095145|2996901|Other|||||||0.395|||||||Wilcoxon rank-sum test|||Baseline to Week 52 p-value|
1631291|NCT02095145|2996901|Other|||||||0.111|||||||Wilcoxon rank-sum test|||Baseline to Week 39 p-value|
1631292|NCT02095145|2996901|Other|||||||0.305|||||||Wilcoxon rank-sum test|||Baseline to Week 26 p-value|
1631293|NCT02095145|2996901|Other|||||||0.743|||||||Wilcoxon rank-sum test|||Baseline to Week 13 p-value|
1631294|NCT02095145|2996902|Other|||||||0.445|||||||Wilcoxon rank-sum test|||Baseline to Week 52 p-value|
1631295|NCT02095145|2996902|Other|||||||0.038|||||||Wilcoxon rank-sum test|||Baseline to Week 39 p-value|
1631296|NCT02095145|2996902|Other|||||||0.711|||||||Wilcoxon rank-sum test|||Baseline to Week 26 p-value|
1631297|NCT02095145|2996902|Other|||||||0.948|||||||Wilcoxon rank-sum test|||Baseline to Week 13 p-value|
1631298|NCT02095145|2996905|Other|||||||0.211|||||||t-test, 2 sided||||
1631299|NCT02095145|2996905|Other|||||||0.19|||||||Wilcoxon rank-sum test||||
1631300|NCT02094937|2996918|Superiority or Other||Odds Ratio (OR)|1.45|||||2-Sided|95.0|0.66|3.2|||||||
1631301|NCT02094937|2996918|Superiority or Other||Odds Ratio (OR)|1.93|||||2-Sided|95.0|0.9|4.12|||||||
1631302|NCT02094937|2996919|Superiority or Other||Hazard Ratio (HR)|0.79|||||2-Sided|95.0|0.28|2.19|||||||
1631303|NCT02094937|2996919|Superiority or Other||Hazard Ratio (HR)|0.88|||||2-Sided|95.0|0.31|2.49|||||||
1631304|NCT02094898|2996921|Superiority||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.|
1631307|NCT02094898|2996923|Superiority||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.|
1631308|NCT02094898|2996923|Superiority||||||<|0.05|||||||t-test, 2 sided|||alpha level of 0.05.|
1631309|NCT02094898|2996924|Superiority||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.|
1631310|NCT02094898|2996925|Superiority||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.|
1631311|NCT02094898|2996925|Superiority||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.|
1631312|NCT02094898|2996926|Superiority||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.|
1631313|NCT02094898|2996927|Superiority||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.|
1631314|NCT02094898|2996927|Superiority||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.|
1631315|NCT02094898|2996928|Superiority||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.|
1631316|NCT02094898|2996929|Superiority||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.|
1631317|NCT02094898|2996929|Superiority||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.|
1631318|NCT02094898|2996930|Superiority||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.|
1631319|NCT02094898|2996931|Superiority||||||<|0.08|||||||t-test, 2 sided|||alpha level of 0.05.|
1631320|NCT02094898|2996931|Superiority||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.|
1631321|NCT02094898|2996931|Superiority||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.|
1631322|NCT02094898|2996932|Superiority||||||<|0.001|||||||t-test, 2 sided|||alpha level of 0.05.|
1631323|NCT02094898|2996933|Superiority||||||<|0.05|||||||t-test, 2 sided|||alpha level of 0.05.|
1631324|NCT02094898|2996933|Superiority||||||<|0.01|||||||t-test, 2 sided|||alpha level of 0.05.|
1631325|NCT02093923|2997025|Superiority or Other||Percent difference in mean attack rate|-91.1||||0.0012|2-Sided|95.0|-97.9|-61.6|||Mixed Models Analysis||The calculation of percent change in mean rate (vs Placebo) is based on Generalized Estimating Equation (GEE) approach.||
1631326|NCT02093923|2997025|Superiority or Other||Percent difference in mean attack rate|-87.8||||0.005|2-Sided|95.0|-97.2|-46.9|||Mixed Models Analysis||The calculation of percent change in mean rate (vs Placebo) is based on Generalized Estimating Equation (GEE) approach.||
1631327|NCT02093923|2997025|Superiority or Other||Percent difference in mean attack rate|-100.0||||0.0001|2-Sided|95.0|-100.0|-100.0|||Mixed Models Analysis||The calculation of percent change in mean rate (vs Placebo) is based on Generalized Estimating Equation (GEE) approach.||
1631328|NCT02093819|2997049|Superiority or Other||Slope|0.9603|Standard Error of the Mean|0.0838|||2-Sided|90.0|0.8174|1.1032|||||Evaluation of dose proportionality - dose groups 50 mg to 600 mg. Number of subjects included in the analysis 28.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.|
1631329|NCT02093819|2997049|Superiority or Other||Slope|1.0732|Standard Error of the Mean|0.0468|||2-Sided|90.0|0.9946|1.1518|||||Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.|
1631330|NCT02093819|2997050|Superiority or Other||Slope|0.9568|Standard Error of the Mean|0.1019|||2-Sided|90.0|0.783|1.1307|||||Evaluation of dose proportionality - dose groups 50mg to 600mg. Number of subjects included in the analysis=28.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.|
1631331|NCT02093819|2997050|Superiority or Other||Slope|1.1313|Standard Error of the Mean|0.0633|||2-Sided|90.0|1.0249|1.2376|||||Evaluation of dose proportionality - all dose groups. Number of subjects included in the analysis=44.|A power model was used to describe functional relationship between dose and Pk parameters. For the evaluation of dose proportionality,slope parameter (B), a two-sided 90% confidence interval of the slope was calculated. Perfect dose proportionality would correspond to a slope of 1.|
1631332|NCT02093663|2997065|Other||Difference in proportions|-9.0||||0.194|2-Sided|95.0|-29.1|11.0||P-value was based on a CMH test adjusted by prior response status. Participants with remission (PUCAI <10) at double-blind maintenance phase at Week 26 was compared between treatment arms using a CMH test stratifying by Week 8 responder status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.|
1631333|NCT02093663|2997066|Other||Difference in Least squares Mean|3.0||||0.182|2-Sided|95.0|-1.4|7.4||P-value was based on an analysis of covariance (ANCOVA) including treatment arm and with prior response status.|ANCOVA|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.|
1631334|NCT02093663|2997067|Other||Difference in proportions|-16.2||||0.129|2-Sided|95.0|-36.0|3.6||P-value was based on a Cochran-Mantel-Haenszel (CMH) test adjusted by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.|
1631335|NCT02093663|2997068|Other||Difference in Proportions Percentage|-6.5||||0.539|2-Sided|95.0|-25.3|12.3||P-value is based on a CMH test adjusted by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.|
1631357|NCT02093234|2997110|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1631786|NCT02082184|2997917|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.63||0.597|2-Sided||||||ANCOVA|||Statistical analysis of time spent >180 mg/dL|
1631336|NCT02093663|2997069|Other||Difference in proportions|24.5||||0.131|2-Sided|95.0|-1.6|50.6||P-value was based on a continuity-corrected chi-squared test. PUCAI Score was compared between treatment arms using a continuity corrected chi-squared test. Expected cell counts are very low (< 5), then Fisher’s Exact Test is alternative method.|Chi-squared, Corrected|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.|
1631337|NCT02093663|2997070|Other||Difference in Least squares Mean|-5.4||||0.168|2-Sided|95.0|-13.1|2.4||P-value is based on an analysis of covariance (ANCOVA) including treatment arm as a factor and baseline DUCS score as a covariate.|ANCOVA|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.|
1631338|NCT02093663|2997071|Other||Difference in proportions|50.0||||0.333|2-Sided|95.0|-19.3|100.0||P-value was based on a Fisher's exact test.|Fisher Exact|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate.|
1631339|NCT02093663|2997072|Other||Difference in proportions|50.0||||0.4|2-Sided|95.0|-19.3|100.0||P-value was calculated based on Fisher's exact test.|Fisher Exact|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.|
1631340|NCT02093663|2997073|Other||Odds Ratio (OR)|0.99||||0.981|2-Sided|95.0|0.42|2.34||P-value were based on a Cochran-Mantel-Haenszel test stratified by prior response status.|Cochran-Mantel-Haenszel|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (LOCF and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-value s were presented as descriptive statistics.|
1631341|NCT02093663|2997074|Other||Odds Ratio (OR)|3.21||||0.039|2-Sided|95.0|1.04|9.88|||Uncorrected Chi-squared Test|||This study is not powered to detect differences between treatment groups and other sensitivity analysis (last observation carried forward [LOCF] and complete case) intended to examine the robustness of the treatment estimate. This was an estimation study, and p-values were presented as descriptive statistics.|
1631342|NCT02093351|2997095|Equivalence|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.15|||||2-Sided|90.0|1.07|1.25|||||olaparib + letrozole vs. olaparib|Analysis of olaparib PK parameters.|
1631343|NCT02093351|2997096|Equivalence|If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.|GLS Mean Ratio|0.95|||||2-Sided|90.0|0.91|0.99|||||olaparib + letrozole vs. letrozole|Analysis of letrozole PK parameters.|
1631344|NCT02093351|2997097|Equivalence|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.89|||||2-Sided|90.0|0.76|1.05|||||olaparib + anastrozole vs. olaparib|Analysis of olaparib PK parameters.|
1631345|NCT02093351|2997098|Equivalence|If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.|GLS Mean Ratio|0.86|||||2-Sided|90.0|0.8|0.93|||||olaparib + anastrozole vs. anastrozole|Analysis of anastrozole PK parameters.|
1631346|NCT02093351|2997099|Equivalence|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.73|||||2-Sided|90.0|0.63|0.84|||||olaparib + tamoxifen vs. olaparib|Analysis of olaparib PK parameters.|
1631347|NCT02093351|2997100|Equivalence|If the 90% CI for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.16|||||2-Sided|90.0|1.11|1.21|||||olaparib + tamoxifen vs. tamoxifen|Analysis of tamoxifen PK parameters.|
1631348|NCT02093351|2997101|Equivalence|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, letrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.09|||||2-Sided|90.0|0.99|1.21|||||olaparib + letrozole vs. olaparib|Analysis of olaparib PK parameters|
1631349|NCT02093351|2997102|Equivalence|If the 90% CI for the letrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on letrozole exposure.|GLS Mean Ratio|0.94|||||2-Sided|90.0|0.91|0.98|||||olaparib + letrozole vs. letrozole|Analysis of letrozole PK parameters.|
1631350|NCT02093351|2997103|Equivalence|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, anastrozole can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.94|||||2-Sided|90.0|0.84|1.04|||||olaparib + anastrozole vs. olaparib|Analysis of olaparib PK parameters.|
1631351|NCT02093351|2997104|Equivalence|If the 90% CI for the anastrozole treatment ratio falls within 0.8 to 1.25, olaparib can be considered to have had little or no effect on anastrozole exposure.|Geometric Least Squares (GLS) Mean Ratio|0.9|||||2-Sided|90.0|0.84|0.97|||||olaparib + anastrozole vs. anastrozole|Analysis of anastrozole PK parameters.|
1631352|NCT02093351|2997105|Equivalence|If the 90% CI for the olaparib treatment ratio falls within 0.7 to 1.43, tamoxifen can be considered to have had an effect on olaparib exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|0.8|||||2-Sided|90.0|0.71|0.9|||||olaparib + tamoxifen vs. olaparib|Analysis of olaparib PK parameters.|
1631353|NCT02093351|2997106|Equivalence|If the 90% confidence interval (CI) for the tamoxifen treatment ratio falls within 0.7 to 1.43, olaparib can be considered to have had an effect on tamoxifen exposure that is unlikely to be clinically relevant.|GLS Mean Ratio|1.13|||||2-Sided|90.0|1.06|1.22|||||olaparib + tamoxifen vs. tamoxifen|Analysis of tamoxifen PK parameters.|
1631354|NCT02093234|2997107|Superiority or Other|||||||0.02|||||||Wilcoxon signed rank||||
1631355|NCT02093234|2997108|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1631356|NCT02093234|2997109|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1631358|NCT02092961|2997132|Superiority or Other||Least Square Mean Treatment Difference|-0.34||||0.496|2-Sided|90.0|-1.16|0.49|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.||Change from baseline at Week 24. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.|
1631359|NCT02092961|2997132|Superiority or Other||Least Square Mean Treatment Difference|0.89||||0.006|2-Sided|90.0|0.36|1.41|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and DMARD naivety (DMARD naive vs DMARD-IR/intolerant) as factors.||Change from baseline at Week 6. Nonresponder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data. Patients who prematurely withdrew due to project closure have no imputation applied.|
1631360|NCT02092961|2997133|Superiority or Other||Treatment difference|1.25||||0.053|2-Sided|90.0|0.5|2.5||A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference <0 indicates a benefit towards fostamatinib.|24 weeks|
1631361|NCT02092961|2997133|Superiority or Other||Treatment difference|0.0||||0.366|2-Sided|90.0|-0.5|0.0||A negative value for change from baseline in OMERACT RAMRIS erosions score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference <0 indicates a benefit towards fostamatinib.|6 weeks|
1631362|NCT02092961|2997134|Superiority or Other||Treatment difference|0.0||||0.341|2-Sided|90.0|0.0|0.0||A negative value for change from baseline in JSN score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference <0 indicates a benefit towards fostamatinib.|24 weeks|
1631363|NCT02092961|2997134|Superiority or Other||Treatment difference|0.0||||0.491|2-Sided|90.0|0.0|0.0||A negative value for change from baseline in JSN score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference <0 indicates a benefit towards fostamatinib.|6 weeks|
1631364|NCT02092961|2997135|Superiority or Other||Treatment difference|1.0||||0.413|2-Sided|90.0|-1.5|3.5||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference <0 indicates a benefit towards fostamatinib.|24 weeks|
1631365|NCT02092961|2997135|Superiority or Other||Treatment difference|0.0||||0.746|2-Sided|90.0|-1.0|0.5||A negative value for change from baseline in OMERACT RAMRIS osteitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference <0 indicates a benefit towards fostamatinib.|6 weeks|
1631366|NCT02092961|2997136|Superiority or Other||Treatment difference|0.5||||0.402|2-Sided|90.0|-1.0|2.0||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference <0 indicates a benefit towards fostamatinib.|24 weeks|
1631367|NCT02092961|2997136|Superiority or Other||Treatment difference|-1.75||||0.022|2-Sided|90.0|-2.75|-0.42||A negative value for change from baseline in OMERACT RAMRIS synovitis score indicates a better clinical condition.|Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant).|The point estimate for the median difference in change from baseline and associated 90% CI was calculated using the method of unstratified Hodges-Lehmann. A treatment difference <0 indicates a benefit towards fostamatinib.|6 weeks|
1631368|NCT02092350|2997175|Superiority or Other|||||||0.001|||||||One-sided exact test|||The primary hypothesis was that the SVR12 rate in the Immediate Treatment plus Intensive PK arm would be >45%.|
1631369|NCT02092220|2997207|Superiority||Mean Difference (Final Values)|1.3|||<|0.0001|2-Sided|95.0|0.8|1.8||Repeated measures model.|t-test, 2 sided||||
1631370|NCT02092220|2997208|Superiority||Mean Difference (Final Values)|-20.28|Standard Deviation|24.59|<|0.0001|2-Sided|95.0|-28.0|-12.56||Repeated measures model.|t-test, 2 sided||Bionic Pancreas Arm - Usual Care Arm||
1631371|NCT02091986|2997221|Superiority or Other|||||||0.449|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group|||
1631372|NCT02091986|2997221|Superiority or Other|||||||0.367|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group|||
1631373|NCT02091986|2997221|Superiority or Other|||||||0.098|||||||ANCOVA|The explanatory variables included in the model are: treatment group, baseline overall PAQLQ(S) score, region and age group|||
1631374|NCT02091986|2997225|Superiority or Other|||||||0.138|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631375|NCT02091986|2997225|Superiority or Other|||||||0.342|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631851|NCT02081807|2997957|Other||Hazard Ratio (HR)|1.01|||||2-Sided|95.0|0.92|1.12||||||MarketScan-Rivaroxaban vs. Warfarin (as reference group).|
1631376|NCT02091986|2997225|Superiority or Other|||||||0.015|||||||ANCOVA|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631377|NCT02091986|2997226|Superiority or Other|||||||0.913|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631378|NCT02091986|2997226|Superiority or Other|||||||0.747|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631379|NCT02091986|2997226|Superiority or Other|||||||0.664|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631380|NCT02091986|2997227|Superiority or Other|||||||0.929|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631381|NCT02091986|2997227|Superiority or Other|||||||0.621|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631382|NCT02091986|2997227|Superiority or Other|||||||0.684|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631383|NCT02091986|2997228|Superiority or Other|||||||0.128|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631384|NCT02091986|2997228|Superiority or Other|||||||0.985|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631385|NCT02091986|2997228|Superiority or Other|||||||0.134|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631386|NCT02091986|2997229|Superiority or Other|||||||0.811|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631387|NCT02091986|2997229|Superiority or Other|||||||0.909|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631388|NCT02091986|2997229|Superiority or Other|||||||0.724|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631389|NCT02091986|2997230|Superiority or Other|||||||0.165|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631390|NCT02091986|2997230|Superiority or Other|||||||0.759|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631391|NCT02091986|2997230|Superiority or Other|||||||0.276|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631392|NCT02091986|2997231|Superiority or Other|||||||0.326|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631393|NCT02091986|2997231|Superiority or Other|||||||0.005|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631394|NCT02091986|2997231|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631395|NCT02091986|2997232|Superiority or Other|||||||0.032|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631396|NCT02091986|2997232|Superiority or Other|||||||0.195|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631397|NCT02091986|2997232|Superiority or Other|||||||0.001|||||||Mixed Models Analysis|Baseline lung function assessment, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631398|NCT02091986|2997233|Superiority or Other|||||||0.373|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631399|NCT02091986|2997233|Superiority or Other|||||||0.063|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631400|NCT02091986|2997233|Superiority or Other|||||||0.006|||||||Mixed Models Analysis|Baseline FEV1, Treatment group, Region, Age were all included as explanatory variables in the linear predictor.|||
1631401|NCT02091856|2997250|Superiority or Other||||||<|0.01||||||The a priori threshold for statistical significance was set at .05|t-test, 1 sided||||
1631402|NCT02091856|2997251|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was set at .05|ANOVA||||
1631403|NCT02091856|2997252|Superiority or Other||||||<|0.01||||||The a priori threshold for statistical significance was set at .05|ANOVA||||
1631404|NCT02091856|2997253|Superiority or Other||||||>|0.05||||||The a priori threshold for statistical significance was set at .05|ANOVA|Changes in secondary outcome measures were evaluated using repeated measures ANOVA (C-CBT, R-CBT, WLCG at pre- and post-intervention).|||
1631405|NCT02091856|2997254|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was set at .05|ANOVA|Changes in primary outcome measures were evaluated using repeated measures ANOVA for three groups: C-CBT, R-CBT, WLCG and two time points: pre & post||It was hypothesized that regardless of the CBT version received (conventional or religious), those in the active treatments would achieve a greater reduction in depressive and associated symptoms than participants in the wait-list condition.|
1631430|NCT02090413|2997366|Superiority or Other||Mean Difference (Final Values)|-0.308|||||2-Sided|95.0|-0.867|0.251|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined|
1631406|NCT02091739|2997266|Superiority||LS mean difference|0.35|Standard Error of the Mean|0.181|=|0|2-Sided|95.0|-0.01|0.71|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~IncobotulinumtoxinA 100 units v Placebo~IncobotulinumtoxinA 75 units v Placebo"|
1631407|NCT02091739|2997266|Superiority||LS mean difference|0.58|Standard Error of the Mean|0.183|=|0|2-Sided|95.0|0.22|0.94|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~IncobotulinumtoxinA 100 units v Placebo~IncobotulinumtoxinA 75 units v Placebo"|
1631408|NCT02091739|2997267|Superiority||LS mean difference|-0.02|Standard Error of the Mean|0.03|=|0|2-Sided|95.0|-0.08|0.04|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square means estimates of an MMRM model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~IncobotulinumtoxinA 100 units v Placebo~IncobotulinumtoxinA 75 units v Placebo"|
1631409|NCT02091739|2997267|Superiority||LS mean difference|-0.09|Standard Error of the Mean|0.031|=|0|2-Sided|95.0|-0.15|0.03|||MMRM|||"A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square (LS) means estimates of an mixed model repeated measurement (MMRM) model (2-sided, significance level alpha=0.05) between treatment groups in the following order:~IncobotulinumtoxinA 100 units versus (v) Placebo~IncobotulinumtoxinA 75 units v Placebo"|
1631410|NCT02091466|2997276|Superiority or Other||||||<|0.05|||||||ANCOVA|||Analysis of covariance for repeated measures (ANCOVA), adjusted for baseline values, compared tympanic temperatures between the groups. Statistical significance was established at p < 0.05, and the statistical analysis was performed using SPSS (Statistical Package for the Social Sciences) software version 20.|
1631411|NCT02091440|2997277|Other|Single group|Change from baseline|130.0|Standard Deviation|275.32|||2-Sided|95.0|-158.9|418.9|||||Confidence interval based on t-distribution.||
1631412|NCT02091440|2997278|Other|Single group|Percentage change|-83.33|||||2-Sided||||||||Percentage change from 24 months to screening in NYHA classes III and IV. Percentage change is 16.67% - 100% = -83.33%||
1631413|NCT02091440|2997279|Other|Single group|Change from baseline|19.4|Standard Deviation|11.39|||2-Sided|95.0|7.5|31.4|||||Confidence interval based on t-distribution.||
1631414|NCT02091440|2997280|Other|Single group|Incidence|1.66|||||2-Sided||||||||||
1631415|NCT02091440|2997281|Other|Single group|Incidence|1.24|||||2-Sided||||||||||
1631416|NCT02091440|2997282|Other|Single group|Kaplan-Meier Survival|100.0|||||2-Sided||||||||||
1631417|NCT02091440|2997283|Other|Single group|Proportion|100.0|||||2-Sided|95.0|||||||||
1631418|NCT02091375|2997303|Superiority||Odds Ratio (OR)|2.0||||0.0784|2-Sided|95.0|0.93|4.3|||Cochran-Mantel-Haenszel|Stratified by age group (2-5 years, 6-12 years, and 13-18 years).|||
1631419|NCT02091375|2997304|Superiority||Median Difference (Final Values)|-22.79||||0.0123|2-Sided|95.0|-41.06|-5.43|||Wilcoxon rank-sum test||Calculated using the Hodges–Lehmann approach.||
1631420|NCT02091362|2997311|Superiority or Other||LS Mean Difference|1.37|||<|0.01|2-Sided|95.0|0.66|2.08|||Mixed Models Analysis||||
1631421|NCT02091362|2997312|Superiority or Other||LS Mean Difference|2.26|||<|0.001|2-Sided|95.0|1.11|3.4|||Mixed Models Analysis||||
1631422|NCT02091284|2997319|Other||||||<|0.05|||||||t-test, 2 sided|||Additional comparisons between initial and final OCDS scores were done by paired t tests for each group, and differences between final and initial scores were compared between sham-tDCS and tDCS groups with unpaired t tests.|
1631423|NCT02091284|2997319|Other||||||<|0.01||||||Two-way ANOVA with repeated measures followed by Bonferroni’s multiple comparisons as post-hoc test and linear regression analyses. Additional comparisons between initial and final OCDS scores were done by paired t tests for each group.|ANOVA||||
1631424|NCT02091167|2997323|Other|||||||0.05|||||||Fisher Exact|||Two patients from each group were lost to follow-up after their discharge from the hospital.|
1631425|NCT02091167|2997324|Other|||||||0.05|||||||ANOVA|||We powered for a medium effect size based on our previous study with effect size (partial ղ2) of 0.10384 for the main within-subject factor in the two-way ANOVA with repeated measures. With a power of 80%, and a two-sided probability of a type I error of 5%, the resulting minimum sample size was 30 participants. To account for waiving or dropouts we increased the estimated sample size to approximately 10%, resulting in 33 subjects in total (approximately 16 to 17 subjects in each group).|"Most of data (age, patterns of crack-cocaine use, 5-items OCCS) were normally distributed according to the D'Agostino & Pearson normality test, thus they were analyzed by parametric tests. Between-group (sham- and real tDCS) comparisons were conducted by unpaired Student´s t-tests. For all other non-parametric data (gender, schooling, employment, marital state and tobacco use), Chi-square or Fisher tests were used to compare sham and real tDCS groups.~Besides the two-way ANOVA with repeated measures followed by Bonferroni-corrected t-tests, linear regression analyses were done over craving scores obtained along the 4-week treatment (five time-points measurements) for both groups. Additional comparisons between initial and final OCDS scores were done by paired t-tests for each group, and differences between final and initial scores were compared between sham-tDCS and real tDCS groups with unpaired t-test."
1631426|NCT02090764|2997332|Superiority or Other|||||||0.001|||||||Chi-squared|||The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) was provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.|
1631427|NCT02090413|2997366|Superiority or Other||Mean Difference (Final Values)|-0.084|||||2-Sided|95.0|-0.4|0.232|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined|
1631428|NCT02090413|2997366|Superiority or Other||Mean Difference (Final Values)|-0.06|||||2-Sided|95.0|-0.374|0.254|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined|
1631429|NCT02090413|2997366|Superiority or Other||Mean Difference (Final Values)|0.024|||||2-Sided|95.0|-0.308|0.355|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 9-12 combined|
1631852|NCT02081807|2997957|Other||Hazard Ratio (HR)|1.06|||||2-Sided|95.0|0.88|1.26||||||Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631431|NCT02090413|2997366|Superiority or Other||Mean Difference (Final Values)|0.069|||||2-Sided|95.0|-0.498|0.635|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined|
1631432|NCT02090413|2997366|Superiority or Other||Mean Difference (Final Values)|0.376|||||2-Sided|95.0|-0.193|0.945|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 5-8 combined|
1631433|NCT02090413|2997366|Superiority or Other||Mean Difference (Final Values)|-0.247|||||2-Sided|95.0|-0.507|0.012|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined|
1631434|NCT02090413|2997366|Superiority or Other||Mean Difference (Final Values)|-0.392|||||2-Sided|95.0|-0.656|-0.128|||||ANCOVA model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined|
1631435|NCT02090413|2997366|Superiority or Other||Mean Difference (Final Values)|-0.145|||||2-Sided|95.0|-0.414|0.125|||||Analysis of variance model (ANCOVA) model was used with treatment, center as effects and baseline characteristics as covariates.|Weeks 1-4 combined|
1631436|NCT02090413|2997370|Superiority or Other||Difference in percentage|8.4|||||2-Sided|95.0|-8.5|25.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 9-12 combined|
1631437|NCT02090413|2997370|Superiority or Other||Difference in percentage|3.8|||||2-Sided|95.0|-13.2|20.8|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 9-12 combined|
1631438|NCT02090413|2997370|Superiority or Other||Difference in percentage|9.4|||||2-Sided|95.0|-6.8|25.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 5-8|
1631439|NCT02090413|2997370|Superiority or Other||Difference in percentage|9.4|||||2-Sided|95.0|-6.8|25.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Itching, Weeks 5-8 combined|
1631440|NCT02090413|2997370|Superiority or Other||Difference in percentage|7.1|||||2-Sided|95.0|-9.6|23.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 9-12 combined|
1631441|NCT02090413|2997370|Superiority or Other||Difference in percentage|-5.2|||||2-Sided|95.0|-22.1|11.8|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 9-12 combined|
1631442|NCT02090413|2997370|Superiority or Other||Difference in percentage|13.7|||||2-Sided|95.0|-1.9|29.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 5-8 combined|
1631443|NCT02090413|2997370|Superiority or Other||Difference in percentage|-2.0|||||2-Sided|95.0|-18.4|14.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Tingling, Weeks 5-8 combined|
1631444|NCT02090413|2997370|Superiority or Other||Difference in percentage|4.8|||||2-Sided|95.0|-10.3|19.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 9-12 combined|
1631445|NCT02090413|2997370|Superiority or Other||Difference in percentage|0.2|||||2-Sided|95.0|-15.3|15.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 9-12 combined|
1631446|NCT02090413|2997370|Superiority or Other||Difference in percentage|2.6|||||2-Sided|95.0|-10.2|15.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 5-8 combined|
1631447|NCT02090413|2997370|Superiority or Other||Difference in percentage|-0.3|||||2-Sided|95.0|-13.5|12.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Warmth, Weeks 5-8 combined|
1631448|NCT02090413|2997370|Superiority or Other||Difference in percentage|3.3|||||2-Sided|95.0|-12.0|18.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 9-12 combined|
1631449|NCT02090413|2997370|Superiority or Other||Difference in percentage|-9.0|||||2-Sided|95.0|-25.1|7.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 9-12 combined|
1631450|NCT02090413|2997370|Superiority or Other||Difference in percentage|4.0|||||2-Sided|95.0|-9.4|17.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 5-8 combined|
1631451|NCT02090413|2997370|Superiority or Other||Difference in percentage|-1.8|||||2-Sided|95.0|-15.7|12.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Redness, Weeks 5-8 combined|
1631452|NCT02090413|2997370|Superiority or Other||Difference in percentage|12.3|||||2-Sided|95.0|-2.8|27.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 9-12 combined|
1631453|NCT02090413|2997370|Superiority or Other||Difference in percentage|3.1|||||2-Sided|95.0|-12.8|18.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 9-12 combined|
1631454|NCT02090413|2997370|Superiority or Other||Difference in percentage|4.0|||||2-Sided|95.0|-8.6|16.6|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 5-8 combined|
1631455|NCT02090413|2997370|Superiority or Other||Difference in percentage|2.6|||||2-Sided|95.0|-10.2|15.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing, Weeks 5-8 combined|
1631456|NCT02090413|2997371|Superiority or Other||Difference in percentage|15.7|||||2-Sided|95.0|0.2|31.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 9-12 combined|
1631457|NCT02090413|2997371|Superiority or Other||Difference in percentage|6.5|||||2-Sided|95.0|-9.9|23.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 9-12 combined|
1632271|NCT02072226|2998866|Other|Confidence Interval|Adjusted Risk Difference|-1.1|||||2-Sided|95.0|-9.44|7.25|||||||
1631458|NCT02090413|2997371|Superiority or Other||Difference in percentage|5.4|||||2-Sided|95.0|-8.4|19.1|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 5-8 combined|
1631459|NCT02090413|2997371|Superiority or Other||Difference in percentage|-1.4|||||2-Sided|95.0|-15.8|13.0|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 5-8 combined|
1631460|NCT02090413|2997374|Superiority or Other||Difference in percentage|-11.3|||||2-Sided|95.0|-23.1|0.6|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall itching events|
1631461|NCT02090413|2997374|Superiority or Other||Difference in percentage|-8.0|||||2-Sided|95.0|-19.5|3.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall itching events|
1631462|NCT02090413|2997374|Superiority or Other||Difference in percentage|5.0|||||2-Sided|95.0|-6.4|16.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall tingling events|
1631463|NCT02090413|2997374|Superiority or Other||Difference in percentage|5.9|||||2-Sided|95.0|-5.4|17.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall tingling events|
1631464|NCT02090413|2997374|Superiority or Other||Difference in percentage|5.0|||||2-Sided|95.0|-1.7|11.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall warmth events|
1631465|NCT02090413|2997374|Superiority or Other||Difference in percentage|4.9|||||2-Sided|95.0|-1.8|11.7|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall warmth events|
1631466|NCT02090413|2997374|Superiority or Other||Difference in percentage|-1.3|||||2-Sided|95.0|-10.8|8.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall redness events|
1631467|NCT02090413|2997374|Superiority or Other||Difference in percentage|-1.5|||||2-Sided|95.0|-11.2|8.1|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall redness events|
1631468|NCT02090413|2997374|Superiority or Other||Difference in percentage|5.0|||||2-Sided|95.0|-2.5|12.5|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing events|
1631469|NCT02090413|2997374|Superiority or Other||Difference in percentage|4.9|||||2-Sided|95.0|-2.6|12.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Overall flushing events|
1631470|NCT02090413|2997375|Superiority or Other||Difference in percentage|-4.8|||||2-Sided|95.0|-21.0|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 4|
1631471|NCT02090413|2997375|Superiority or Other||Difference in percentage|-4.8|||||2-Sided|95.0|-21.0|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 4|
1631472|NCT02090413|2997375|Superiority or Other||Difference in percentage|-19.0|||||2-Sided|95.0|-34.1|-3.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 3|
1631473|NCT02090413|2997375|Superiority or Other||Difference in percentage|-17.6|||||2-Sided|95.0|-32.8|-2.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 3|
1631474|NCT02090413|2997375|Superiority or Other||Difference in percentage|-7.0|||||2-Sided|95.0|-20.9|6.9|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 2|
1631475|NCT02090413|2997375|Superiority or Other||Difference in percentage|-14.8|||||2-Sided|95.0|-29.2|-0.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 2|
1631476|NCT02090413|2997375|Superiority or Other||Difference in percentage|0.0|||||2-Sided|95.0|-11.4|11.4|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 1|
1631477|NCT02090413|2997375|Superiority or Other||Difference in percentage|2.0|||||2-Sided|95.0|-9.3|13.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Week 1|
1631478|NCT02090413|2997375|Superiority or Other||Difference in percentage|-1.3|||||2-Sided|95.0|-10.8|8.3|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 1-4 combined|
1631479|NCT02090413|2997375|Superiority or Other||Difference in percentage|2.4|||||2-Sided|95.0|-6.4|11.2|||||Two sided 95% CI of difference in proportions was constructed based on the normal approximation to the binomial distribution.|Weeks 1-4 combined|
1631480|NCT02089659|2997403|Other||Geometric Mean Ratio|0.99|||||2-Sided|90.0|0.74|1.33|||||Moderate hepatic insufficiency / Healthy controls||
1631481|NCT02089659|2997404|Other||Geometric Mean Ratio|0.93|||||2-Sided|90.0|0.74|1.18|||||Moderate hepatic insufficiency / Healthy controls||
1631482|NCT02089659|2997405|Other||Geometric Mean Ratio|0.9|||||2-Sided|90.0|0.66|1.24|||||Moderate hepatic insufficiency / Healthy controls||
1631483|NCT02089659|2997406|Other||Geometric Mean Ratio|0.99|||||2-Sided|90.0|0.72|1.35|||||Moderate hepatic insufficiency / Healthy controls||
1631484|NCT02089347|2997414|Non-Inferiority or Equivalence|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%.|Wilson score method|0.0|||||2-Sided|95.0|-1.09|2.14||||||Non-inferiority comparison of Tetanus post-vaccination seroprotection rates at ≥ 0.1 IU/mL|
1631485|NCT02089347|2997414|Non-Inferiority or Equivalence|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%|Wilson score method|0.57|||||2-Sided|95.0|-0.61|3.15||||||Non-inferiority comparison of Diphtheria post-vaccination seroprotection rates at ≥ 0.1 IU/mL|
1631486|NCT02089347|2997415|Non-Inferiority or Equivalence|Non-inferiority is supported by the data if lower bound ot the two-sided 95% is greater than -10%|Wilson score method|6.25|||||2-Sided|95.0|3.32|10.84||||||Non-inferiority comparison of post-vaccination booster response for tetanus|
1631487|NCT02089347|2997415|Non-Inferiority or Equivalence|Non-inferiority is supported by a data if the lower bound of the two-sided 95% confidence interval (CI) is greater than -10%|Wilson score method|1.42|||||2-Sided|95.0|-0.31|4.61||||||Non-inferiority comparison of post-booster response for Diphtheria.|
1631488|NCT02088905|2997427|Superiority||||||<|0.001||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of DPICS Positive Skills between Week 18 scores, 1 sided test for Treatment Group Superiority. Data transformed using a square root transformation.|
1631489|NCT02088905|2997427|Superiority||||||<|0.001||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of DPICS Negative Skills between Week 18 scores, 1 sided test for Treatment Group Superiority|
1631490|NCT02088905|2997429|Superiority|||||||0.204||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Restricted and Repetitive Behavior Score between Week 18 scores, 1 sided test for Treatment Group Superiority|
1631491|NCT02088905|2997429|Superiority|||||||0.441||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Motivation between Week 18 scores, 1 sided test for Treatment Group Superiority|
1631492|NCT02088905|2997429|Superiority|||||||0.294||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Communication Score between Week 18 scores, 1 sided test for Treatment Group Superiority|
1631493|NCT02088905|2997429|Superiority|||||||0.298||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Cognition Scores between Week 18 scores, 1 sided test for Treatment Group Superiority|
1631494|NCT02088905|2997429|Superiority|||||||0.434||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Awareness Score between Week 18 scores, 1 sided test for Treatment Group Superiority|
1631495|NCT02088905|2997429|Superiority|||||||0.271||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of SRS Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority|
1631496|NCT02088905|2997431|Superiority|||||||0.413||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of PSI Total Score between Week 18 scores, 1 sided test for Treatment Group Superiority|
1631497|NCT02088905|2997431|Superiority|||||||0.308||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of PSI Difficult Child between Week 18 scores, 1 sided test for Treatment Group Superiority|
1631498|NCT02088905|2997431|Superiority|||||||0.17||||||No adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)|||Comparison of PSI Parent-Child Dysfunctional Interaction between Week 18 scores, 1 sided test for Treatment Group Superiority|
1631499|NCT02088905|2997431|Superiority|||||||0.203||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of PSI Parental Distress between Week 18 scores, 1 sided test for Treatment Group Superiority|
1631500|NCT02088905|2997432|Other|Type III Tests of Fixed Effects||||||0.015||||||Mixed Model Analysis - Significance of Treatment Assignment and Timepoint Interaction Term within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint*Treatment Assignment interaction. Random intercept used.|
1631501|NCT02088905|2997432|Other|Type III Tests of Fixed Effects||||||0.182||||||Mixed Model Analysis - Significance of Treatment Assignment within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint*Treatment Assignment interaction. Random intercept used.|
1631502|NCT02088905|2997432|Other|Type III Tests of Fixed Effects|||||<|0.001||||||Mixed Model Analysis - Significance of Timepoint within the model in determining the effectiveness of assigned treatment.|Mixed Models Analysis|||Mixed Model Analysis of ECBI Intensity Scores, with variables of Timepoint, Treatment Assignment, and Timepoint*Treatment Assignment interaction. Random intercept used.|
1631503|NCT02088905|2997432|Superiority||||||<|0.026||||||No adjustment for multiple comparisons.|t-test, 1 sided|||Comparison of ECBI Intensity Score between Week 18 scores, 1 sided test for Treatment Group Superiority|
1631504|NCT02088905|2997432|Superiority||||||<|0.08||||||No adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of ECBI Problem Score between Week 18 scores, 1 sided test for Treatment Group Superiority|
1631505|NCT02087943|2997473|Superiority or Other (legacy)||LS Mean Difference|-4.17||||0.6092|2-Sided|95.0|-20.22|11.88|||ANCOVA||Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, > 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.||
1631506|NCT02087943|2997473|Superiority or Other (legacy)||LS Mean Difference|-5.17||||0.5286|2-Sided|95.0|-21.34|10.99|||ANCOVA||Based on an analysis of covariance model with the percentage change from baseline as the response variable, treatment group and baseline EASI stratification (≤ 20, > 20) as factors, and the baseline average weekly pruritus NRS score as a covariate.||
1631507|NCT02087943|2997474|Superiority or Other (legacy)||Adjusted Difference in Proportion|9.9||||0.2476|2-Sided|95.0|-6.7|26.6|||Cochran-Mantel-Haenszel||Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, > 20) with the CMH weights.||
1631508|NCT02087943|2997474|Superiority or Other (legacy)||Adjusted Difference in Proportion|-1.5||||0.8589|2-Sided|95.0|-18.0|14.9|||Cochran-Mantel-Haenszel||Adjusted differences in proportions was the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, > 20) with the CMH weights.||
1631509|NCT02087943|2997475|Superiority or Other (legacy)||Adjusted Difference in Proportion|8.0||||0.1368|2-Sided|95.0|-2.3|18.2||Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, > 20) with, CMH weights.|Cochran-Mantel-Haenszel||2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.||
1631510|NCT02087943|2997475|Superiority or Other (legacy)||Adjusted Difference in Proportion|-2.7||||0.4938|2-Sided|95.0|-10.2|4.8||Adjusted treatment differences in proportions using the weighted average of the treatment differences across the stratum of baseline EASI score stratification (≤ 20, > 20) with, Cochran-Mantel-Haenszel (CMH) weights.|Cochran-Mantel-Haenszel||2-sided 95% Confidence Intervals (CI) is based on a normal approximation to the weighted average.||
1632272|NCT02072174|2998870|Superiority|||||||0.3383|||||||Fisher Exact||||
1631511|NCT02087943|2997476|Superiority or Other (legacy)||LS Mean Difference|-20.6||||0.0347|2-Sided|95.0|-39.7|-1.5||Based on an analysis of covariance model with the percentage change from Baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, > 20) as factors.|ANCOVA||||
1631512|NCT02087943|2997476|Superiority or Other (legacy)||LS Mean Difference|-15.01||||0.1308|2-Sided|95.0|-34.52|4.5||Based on an analysis of covariance model with the percentage change from baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, > 20) as factors.|ANCOVA||||
1631513|NCT02087904|2997477|Superiority||Response Rate Difference|2.1||||0.763|2-Sided|95.0|-11.3|15.6||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel||||
1631514|NCT02087904|2997477|Superiority||Response Rate Difference|0.8||||0.964|2-Sided|95.0|-12.8|14.5||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel||||
1631515|NCT02087904|2997477|Superiority||Response Rate Difference|-1.3||||0.824|2-Sided|95.0|-14.9|12.4||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel||||
1631516|NCT02087904|2997478|Superiority||Response Rate Difference|10.4||||0.146|2-Sided|95.0|-3.5|24.3||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel||||
1631517|NCT02087904|2997478|Superiority||Response Rate Difference|4.3||||0.581|2-Sided|95.0|-10.1|18.7||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel||||
1631518|NCT02087904|2997478|Superiority||Response Rate Difference|2.4||||0.744|2-Sided|95.0|-11.9|16.8||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel||||
1631519|NCT02087904|2997479|Superiority||Response Rate Difference|5.5||||0.435|2-Sided|95.0|-8.9|19.9||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel||||
1631520|NCT02087904|2997479|Superiority||Response Rate Difference|5.5||||0.435|2-Sided|95.0|-8.9|19.9||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel||||
1631521|NCT02087904|2997479|Superiority||Response Rate Difference|7.0||||0.311|2-Sided|95.0|-7.3|21.4||P-value for test of difference between each ABT-981 dose group and Placebo was from a Cochran-Mantel-Haenszel test using age group and K-L grade as stratification factors.|Cochran-Mantel-Haenszel||||
1631522|NCT02087904|2997480|Superiority||LS Mean Difference|-0.003||||0.835|2-Sided|95.0|-0.032|0.026||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau|
1631523|NCT02087904|2997480|Superiority||LS Mean Difference|0.012||||0.445|2-Sided|95.0|-0.018|0.042||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau|
1631524|NCT02087904|2997480|Superiority||LS Mean Difference|-0.012||||0.413|2-Sided|95.0|-0.041|0.017||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau|
1631525|NCT02087904|2997480|Superiority||LS Mean Difference|-0.006||||0.866|2-Sided|95.0|-0.076|0.064||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau|
1631526|NCT02087904|2997480|Superiority||LS Mean Difference|0.023||||0.535|2-Sided|95.0|-0.049|0.094||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau|
1631527|NCT02087904|2997480|Superiority||LS Mean Difference|-0.04||||0.258|2-Sided|95.0|-0.11|0.03||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau|
1631528|NCT02087904|2997480|Superiority||LS Mean Difference|-0.003||||0.765|2-Sided|95.0|-0.022|0.016||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee|
1631529|NCT02087904|2997480|Superiority||LS Mean Difference|-0.001||||0.952|2-Sided|95.0|-0.02|0.019||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee|
1631530|NCT02087904|2997480|Superiority||LS Mean Difference|-0.005||||0.619|2-Sided|95.0|-0.024|0.014||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee|
1631531|NCT02087904|2997481|Superiority||LS Mean Difference|0.001||||0.887|2-Sided|95.0|-0.018|0.021||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau|
1631532|NCT02087904|2997481|Superiority||LS Mean Difference|-0.002||||0.885|2-Sided|95.0|-0.022|0.019||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau|
1631533|NCT02087904|2997481|Superiority||LS Mean Difference|0.0||||0.965|2-Sided|95.0|-0.019|0.02||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau|
1631534|NCT02087904|2997481|Superiority||LS Mean Difference|0.01||||0.71|2-Sided|95.0|-0.041|0.06||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau|
1631535|NCT02087904|2997481|Superiority||LS Mean Difference|0.011||||0.691|2-Sided|95.0|-0.042|0.064||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau|
1631536|NCT02087904|2997481|Superiority||LS Mean Difference|0.008||||0.752|2-Sided|95.0|-0.043|0.059||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau|
1631537|NCT02087904|2997481|Superiority||LS Mean Difference|-0.005||||0.543|2-Sided|95.0|-0.02|0.01||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee|
1631538|NCT02087904|2997481|Superiority||LS Mean Difference|-0.001||||0.929|2-Sided|95.0|-0.017|0.015||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee|
1631539|NCT02087904|2997481|Superiority||LS Mean Difference|0.0||||0.972|2-Sided|95.0|-0.015|0.015||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee|
1631540|NCT02087904|2997482|Superiority||LS Mean Difference|-28.1||||0.489|2-Sided|95.0|-107.97|51.82||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau|
1631541|NCT02087904|2997482|Superiority||LS Mean Difference|24.4||||0.56|2-Sided|95.0|-58.05|106.91||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau|
1631542|NCT02087904|2997482|Superiority||LS Mean Difference|-40.3||||0.319|2-Sided|95.0|-119.88|39.3||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau|
1631543|NCT02087904|2997482|Superiority||LS Mean Difference|-11.8||||0.608|2-Sided|95.0|-56.94|33.38||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau|
1631544|NCT02087904|2997482|Superiority||LS Mean Difference|11.1||||0.64|2-Sided|95.0|-35.63|57.8||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau|
1631545|NCT02087904|2997482|Superiority||LS Mean Difference|-25.1||||0.272|2-Sided|95.0|-70.12|19.88||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau|
1631546|NCT02087904|2997482|Superiority||LS Mean Difference|-26.1||||0.713|2-Sided|95.0|-165.47|113.32||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee|
1631547|NCT02087904|2997482|Superiority||LS Mean Difference|2.7||||0.97|2-Sided|95.0|-140.86|146.31||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee|
1631548|NCT02087904|2997482|Superiority||LS Mean Difference|-41.7||||0.554|2-Sided|95.0|-180.49|97.04||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee|
1631549|NCT02087904|2997483|Superiority||LS Mean Difference|13.8||||0.602|2-Sided|95.0|-38.05|65.55||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau|
1631550|NCT02087904|2997483|Superiority||LS Mean Difference|4.1||||0.882|2-Sided|95.0|-50.68|58.95||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau|
1631551|NCT02087904|2997483|Superiority||LS Mean Difference|2.1||||0.937|2-Sided|95.0|-49.88|54.08||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial condyle + plateau|
1631552|NCT02087904|2997483|Superiority||LS Mean Difference|1.6||||0.923|2-Sided|95.0|-30.97|34.19||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau|
1631664|NCT02086565|2997557|Superiority||Group differences in expected 12 month c|0.19|||||2-Sided|95.0|-0.27|0.68|||||Estimation parameter: Other. Group differences in expected 12 month change from baseline||
1631553|NCT02087904|2997483|Superiority||LS Mean Difference|9.0||||0.609|2-Sided|95.0|-25.62|43.64||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau|
1631554|NCT02087904|2997483|Superiority||LS Mean Difference|4.2||||0.799|2-Sided|95.0|-28.47|36.95||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Medial central condyle + plateau|
1631555|NCT02087904|2997483|Superiority||LS Mean Difference|-33.1||||0.523|2-Sided|95.0|-134.76|68.65||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee|
1631556|NCT02087904|2997483|Superiority||LS Mean Difference|3.6||||0.948|2-Sided|95.0|-103.95|111.1||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee|
1631557|NCT02087904|2997483|Superiority||LS Mean Difference|0.5||||0.992|2-Sided|95.0|-101.59|102.62||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Global knee|
1631558|NCT02087904|2997484|Superiority||LS Mean Difference|-0.4||||0.3|2-Sided|95.0|-1.22|0.38||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631559|NCT02087904|2997484|Superiority||LS Mean Difference|-0.1||||0.738|2-Sided|95.0|-0.94|0.66||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631560|NCT02087904|2997484|Superiority||LS Mean Difference|0.1||||0.836|2-Sided|95.0|-0.71|0.87||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631561|NCT02087904|2997485|Superiority||LS Mean Difference|-0.2||||0.527|2-Sided|95.0|-0.96|0.49||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631562|NCT02087904|2997485|Superiority||LS Mean Difference|-0.5||||0.145|2-Sided|95.0|-1.26|0.19||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631563|NCT02087904|2997485|Superiority||LS Mean Difference|0.0||||0.984|2-Sided|95.0|-0.73|0.71||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631564|NCT02087904|2997486|Superiority||LS Mean Difference|-0.1||||0.673|2-Sided|95.0|-0.79|0.51||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631565|NCT02087904|2997486|Superiority||LS Mean Difference|-0.4||||0.219|2-Sided|95.0|-1.06|0.24||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631566|NCT02087904|2997486|Superiority||LS Mean Difference|0.1||||0.728|2-Sided|95.0|-0.52|0.75||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631567|NCT02087904|2997487|Superiority||LS Mean Difference|-0.3||||0.513|2-Sided|95.0|-1.02|0.51||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)|
1631568|NCT02087904|2997487|Superiority||LS Mean Difference|-0.5||||0.218|2-Sided|95.0|-1.02|0.51||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631569|NCT02087904|2997487|Superiority||LS Mean Difference|-0.1||||0.761|2-Sided|95.0|-0.87|0.64||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)|
1631570|NCT02087904|2997487|Superiority||LS Mean Difference|-0.4||||0.357|2-Sided|95.0|-1.1|0.4||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)|
1631571|NCT02087904|2997487|Superiority||LS Mean Difference|-0.4||||0.278|2-Sided|95.0|-1.16|0.34||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)|
1631572|NCT02087904|2997487|Superiority||LS Mean Difference|-0.1||||0.696|2-Sided|95.0|-0.89|0.59||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)|
1631573|NCT02087904|2997487|Superiority||LS Mean Difference|-0.2||||0.663|2-Sided|95.0|-1.1|0.7||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain|
1631665|NCT02086565|2997558|Superiority||Group differences in expected 12 month c|-0.21|||||2-Sided|95.0|-0.56|0.15|||||||
1631574|NCT02087904|2997487|Superiority||LS Mean Difference|-0.3||||0.46|2-Sided|95.0|-1.23|0.56||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain|
1631575|NCT02087904|2997487|Superiority||LS Mean Difference|-0.2||||0.633|2-Sided|95.0|-1.1|0.67||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain|
1631576|NCT02087904|2997487|Superiority||LS Mean Difference|-0.2||||0.659|2-Sided|95.0|-0.96|0.61||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period|
1631577|NCT02087904|2997487|Superiority||LS Mean Difference|0.0||||0.925|2-Sided|95.0|-0.75|0.82||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period|
1631578|NCT02087904|2997487|Superiority||LS Mean Difference|0.0||||0.978|2-Sided|95.0|-0.76|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period|
1631579|NCT02087904|2997488|Superiority||LS Mean Difference|-0.1||||0.679|2-Sided|95.0|-0.85|0.57||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)|
1631580|NCT02087904|2997488|Superiority||LS Mean Difference|-0.5||||0.135|2-Sided|95.0|-1.25|0.17||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)|
1631581|NCT02087904|2997488|Superiority||LS Mean Difference|0.1||||0.813|2-Sided|95.0|-0.62|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)|
1631582|NCT02087904|2997488|Superiority||LS Mean Difference|-0.4||||0.209|2-Sided|95.0|-1.15|0.25||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)|
1631583|NCT02087904|2997488|Superiority||LS Mean Difference|-0.4||||0.222|2-Sided|95.0|-1.13|0.26||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)|
1631584|NCT02087904|2997488|Superiority||LS Mean Difference|0.0||||0.957|2-Sided|95.0|-0.68|0.71||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)|
1631585|NCT02087904|2997488|Superiority||LS Mean Difference|0.0||||0.92|2-Sided|95.0|-0.84|0.76||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain|
1631586|NCT02087904|2997488|Superiority||LS Mean Difference|-0.3||||0.433|2-Sided|95.0|-1.12|0.48||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain|
1631587|NCT02087904|2997488|Superiority||LS Mean Difference|-0.1||||0.892|2-Sided|95.0|-0.85|0.74||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain|
1631588|NCT02087904|2997488|Superiority||LS Mean Difference|-0.2||||0.507|2-Sided|95.0|-0.94|0.47||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period|
1631589|NCT02087904|2997488|Superiority||LS Mean Difference|-0.6||||0.122|2-Sided|95.0|-1.26|0.15||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period|
1631590|NCT02087904|2997488|Superiority||LS Mean Difference|-0.2||||0.661|2-Sided|95.0|-0.86|0.54||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period|
1631591|NCT02087904|2997489|Superiority||LS Mean Difference|0.3||||0.387|2-Sided|95.0|-0.37|0.96||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)|
1631592|NCT02087904|2997489|Superiority||LS Mean Difference|-0.1||||0.776|2-Sided|95.0|-0.76|0.57||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)|
1631593|NCT02087904|2997489|Superiority||LS Mean Difference|0.1||||0.67|2-Sided|95.0|-0.51|0.79||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (after)|
1631594|NCT02087904|2997489|Superiority||LS Mean Difference|0.3||||0.367|2-Sided|95.0|-0.35|0.94||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)|
1631595|NCT02087904|2997489|Superiority||LS Mean Difference|0.2||||0.637|2-Sided|95.0|-0.8|0.49||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)|
1631596|NCT02087904|2997489|Superiority||LS Mean Difference|0.2||||0.498|2-Sided|95.0|-0.42|0.85||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Performance pain (before)|
1631597|NCT02087904|2997489|Superiority||LS Mean Difference|0.3||||0.489|2-Sided|95.0|-0.47|0.97||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain|
1631598|NCT02087904|2997489|Superiority||LS Mean Difference|-0.3||||0.344|2-Sided|95.0|-1.07|0.37||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain|
1631599|NCT02087904|2997489|Superiority||LS Mean Difference|0.0||||0.932|2-Sided|95.0|-0.73|0.67||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Activity pain|
1631600|NCT02087904|2997489|Superiority||LS Mean Difference|0.3||||0.331|2-Sided|95.0|-0.31|0.93||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period|
1631601|NCT02087904|2997489|Superiority||LS Mean Difference|-0.2||||0.451|2-Sided|95.0|-0.86|0.38||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period|
1631602|NCT02087904|2997489|Superiority||LS Mean Difference|0.0||||0.874|2-Sided|95.0|-0.56|0.66||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||7-day recall period|
1631603|NCT02087904|2997490|Superiority||LS Mean Difference|-9.2||||0.014|2-Sided|95.0|-16.42|-1.88||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain|
1631604|NCT02087904|2997490|Superiority||LS Mean Difference|-4.6||||0.216|2-Sided|95.0|-11.86|2.69||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain|
1631605|NCT02087904|2997490|Superiority||LS Mean Difference|-1.2||||0.732|2-Sided|95.0|-8.42|5.92||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain|
1631606|NCT02087904|2997490|Superiority||LS Mean Difference|-4.0||||0.278|2-Sided|95.0|-11.23|3.25||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain|
1631607|NCT02087904|2997490|Superiority||LS Mean Difference|-0.4||||0.909|2-Sided|95.0|-7.65|6.81||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain|
1631608|NCT02087904|2997490|Superiority||LS Mean Difference|-2.2||||0.545|2-Sided|95.0|-9.31|4.92||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain|
1631609|NCT02087904|2997491|Superiority||LS Mean Difference|-2.5||||0.437|2-Sided|95.0|-8.91|3.86||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain|
1631610|NCT02087904|2997491|Superiority||LS Mean Difference|-2.0||||0.544|2-Sided|95.0|-8.37|4.43||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain|
1631611|NCT02087904|2997491|Superiority||LS Mean Difference|0.7||||0.817|2-Sided|95.0|-5.59|7.08||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain|
1631612|NCT02087904|2997491|Superiority||LS Mean Difference|-3.0||||0.338|2-Sided|95.0|-9.24|3.18||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain|
1631613|NCT02087904|2997491|Superiority||LS Mean Difference|-2.6||||0.409|2-Sided|95.0|-8.82|3.6||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain|
1631614|NCT02087904|2997491|Superiority||LS Mean Difference|-1.0||||0.75|2-Sided|95.0|-7.14|5.14||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain|
1631615|NCT02087904|2997492|Superiority||LS Mean Difference|-1.4||||0.649|2-Sided|95.0|-7.34|4.58||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain|
1631616|NCT02087904|2997492|Superiority||LS Mean Difference|-5.6||||0.068|2-Sided|95.0|-11.55|0.42||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain|
1631617|NCT02087904|2997492|Superiority||LS Mean Difference|0.9||||0.756|2-Sided|95.0|-4.91|6.76||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Constant pain|
1631618|NCT02087904|2997492|Superiority||LS Mean Difference|1.4||||0.636|2-Sided|95.0|-4.37|7.14||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain|
1631619|NCT02087904|2997492|Superiority||LS Mean Difference|-1.1||||0.699|2-Sided|95.0|-6.9|4.63||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain|
1631620|NCT02087904|2997492|Superiority||LS Mean Difference|0.7||||0.804|2-Sided|95.0|-4.91|6.33||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA|||Intermittent pain|
1631621|NCT02087904|2997493|Superiority||LS Mean Difference|-0.1||||0.83|2-Sided|95.0|-0.61|0.49||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631622|NCT02087904|2997493|Superiority||LS Mean Difference|0.0||||0.953|2-Sided|95.0|-0.55|0.58||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631623|NCT02087904|2997493|Superiority||LS Mean Difference|0.1||||0.602|2-Sided|95.0|-0.41|0.7||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631624|NCT02087904|2997494|Superiority||LS Mean Difference|0.0||||0.966|2-Sided|95.0|-0.45|0.47||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631625|NCT02087904|2997494|Superiority||LS Mean Difference|-0.1||||0.564|2-Sided|95.0|-0.6|0.33||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631626|NCT02087904|2997494|Superiority||LS Mean Difference|0.2||||0.319|2-Sided|95.0|-0.23|0.69||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631627|NCT02087904|2997495|Superiority||LS Mean Difference|-2.3||||0.157|2-Sided|95.0|-5.46|0.88||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631628|NCT02087904|2997495|Superiority||LS Mean Difference|-2.2||||0.186|2-Sided|95.0|-5.39|1.05||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631629|NCT02087904|2997495|Superiority||LS Mean Difference|0.5||||0.5|2-Sided|95.0|-4.26|2.08||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631630|NCT02087904|2997496|Superiority||LS Mean Difference|-2.4||||0.107|2-Sided|95.0|-5.33|0.52||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631631|NCT02087904|2997496|Superiority||LS Mean Difference|-2.7||||0.075|2-Sided|95.0|-5.67|0.28||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631632|NCT02087904|2997496|Superiority||LS Mean Difference|-0.6||||0.664|2-Sided|95.0|-3.58|2.28||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631633|NCT02087904|2997497|Superiority||LS Mean Difference|-6.8||||0.218|2-Sided|95.0|-17.63|4.04||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631634|NCT02087904|2997497|Superiority||LS Mean Difference|-5.8||||0.295|2-Sided|95.0|-16.77|5.11||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631635|NCT02087904|2997497|Superiority||LS Mean Difference|-3.2||||0.558|2-Sided|95.0|-14.03|7.59||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631636|NCT02087904|2997498|Superiority||LS Mean Difference|-7.2||||0.145|2-Sided|95.0|-16.84|2.49||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631637|NCT02087904|2997498|Superiority||LS Mean Difference|-9.2||||0.065|2-Sided|95.0|-18.95|0.56||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631638|NCT02087904|2997498|Superiority||LS Mean Difference|-2.1||||0.666|2-Sided|95.0|-11.76|7.52||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631639|NCT02087904|2997499|Superiority||LS Mean Difference|-3.4||||0.465|2-Sided|95.0|-12.58|5.76||P-value for test of difference between ABT-981 200 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631640|NCT02087904|2997499|Superiority||LS Mean Difference|-7.6||||0.109|2-Sided|95.0|-16.83|1.69||P-value for test of difference between ABT-981 100 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631641|NCT02087904|2997499|Superiority||LS Mean Difference|-1.1||||0.818|2-Sided|95.0|-10.22|8.08||P-value for test of difference between ABT-981 25 mg dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment, age, K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631642|NCT02087904|2997500|Superiority||LS Mean Difference|-0.14||||0.106|2-Sided|95.0|-0.314|0.03||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631643|NCT02087904|2997500|Superiority||LS Mean Difference|-0.15||||0.095|2-Sided|95.0|-0.324|0.026||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631644|NCT02087904|2997500|Superiority||LS Mean Difference|-0.08||||0.384|2-Sided|95.0|-0.249|0.096||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631645|NCT02087904|2997501|Superiority||LS Mean Difference|-1.52||||0.385|2-Sided|95.0|-4.95|1.916||P-value for test of difference between ABT-981 200 dose group and Placebo at each post-baseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631646|NCT02087904|2997501|Superiority||LS Mean Difference|-1.07||||0.542|2-Sided|95.0|-4.515|2.377||P-value for test of difference between ABT-981 100 dose group and Placebo at each post-baseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631647|NCT02087904|2997501|Superiority||LS Mean Difference|0.22||||0.897|2-Sided|95.0|-3.193|3.642||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631648|NCT02087904|2997502|Superiority||LS Mean Difference|0.06||||0.159|2-Sided|95.0|-0.023|0.139||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631649|NCT02087904|2997502|Superiority||LS Mean Difference|-0.03||||0.52|2-Sided|95.0|-0.11|0.056||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631650|NCT02087904|2997502|Superiority||LS Mean Difference|0.06||||0.145|2-Sided|95.0|-0.021|0.141||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631651|NCT02087904|2997503|Superiority||LS Mean Difference|-1.2||||0.415|2-Sided|95.0|-4.0|1.66||P-value for test of difference between ABT-981 200 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631652|NCT02087904|2997503|Superiority||LS Mean Difference|-2.9||||0.05|2-Sided|95.0|-5.73|0.01||P-value for test of difference between ABT-981 100 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and K-L grade as the main factors and baseline as a covariate.|ANCOVA||||
1631653|NCT02087904|2997503|Superiority||LS Mean Difference|-0.3||||0.834|2-Sided|95.0|-3.13|2.53||P-value for test of difference between ABT-981 25 mg dose group and Placebo at each postbaseline time point was from an ANCOVA model with treatment, age, and Kellgren-Lawrence (K-L) grade as the main factors and baseline as a covariate.|ANCOVA||||
1631654|NCT02087748|2997506|Superiority or Other|||||||0.0275|||||||t-test, 2 sided||||
1631655|NCT02087748|2997507|Superiority or Other|||||||0.3688|||||||t-test, 2 sided||||
1631656|NCT02087748|2997508|Superiority or Other|||||||0.0324|||||||t-test, 2 sided||||
1631657|NCT02087085|2997531|Superiority||Least Squares Mean Difference|-1.4|Standard Error of the Mean|1.4||0.301|2-Sided|95.0|-4.2|1.3||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM||||
1631658|NCT02087085|2997532|Superiority||Least Squares Mean Difference|-1.2|Standard Error of the Mean|1.4||0.39|2-Sided|95.0|-3.9|1.5||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM||||
1631659|NCT02087085|2997533|Superiority||Least Squares Mean Difference|-0.3589|Standard Error of the Mean|0.1804||0.047|2-Sided|95.0|-0.7132|-0.0047||MMRM model included treatment group, study region, analysis visit and treatment-by-visit interaction as factors and baseline value and baseline value-by-analysis visit interaction as covariates.|MMRM||||
1631660|NCT02086682|2997550|Superiority|||||||0.79|||||||t-test, 2 sided||||
1631661|NCT02086565|2997554|Superiority||Group differences in expected 12 month c|-0.09|||||2-Sided|95.0|-0.24|0.06|||||||
1631662|NCT02086565|2997555|Superiority||Group differences in expected 12 month c|-0.53|||||2-Sided|95.0|-1.08|-0.24|||||||
1631663|NCT02086565|2997556|Superiority||Group differences in expected 12 month c|-0.6|||||2-Sided|95.0|-2.21|0.97|||||||
1632159|NCT02074982|2998667|Superiority or Other||Odds Ratio (OR)|2.85|||<|0.0001|2-Sided|95.0|2.01|4.02|||Regression, Logistic||||
1631666|NCT02085720|2997579|Non-Inferiority or Equivalence|Data were given as means and standard deviations, unless otherwise stated. AHI was categorized as ≥ 5, ≥ 10, ≥ 15 and ≥ 20. The frequency distribution of responses on the SHQ and their relationship to AHI was assessed with the chi-squared analysis. The association of variables such as age, BMI, neck circumference, ESS and sleep health questionnaire responses versus AHI was evaluated using one-way analysis of variance and Pearson Correlation Analysis.|||||<|0.05|||||||ANOVA||||
1631667|NCT02085447|2997594|Superiority|||||||0.063|||||||t-test, 1 sided||||
1631668|NCT02085447|2997595|Superiority|||||||0.103|||||||t-test, 1 sided||||
1631669|NCT02085447|2997596|Superiority|||||||0.02|||||||t-test, 1 sided||||
1631670|NCT02085447|2997597|Superiority|||||||0.481|||||||t-test, 1 sided||||
1631671|NCT02085447|2997598|Superiority|||||||0.706|||||||t-test, 1 sided||||
1631672|NCT02085447|2997599|Superiority|||||||0.33|||||||t-test, 1 sided||||
1631673|NCT02085447|2997600|Superiority|||||||0.577|||||||t-test, 1 sided||||
1631674|NCT02085447|2997601|Superiority|||||||0.425|||||||t-test, 1 sided||||
1631675|NCT02085447|2997602|Superiority|||||||0.33|||||||t-test, 1 sided||||
1631676|NCT02085447|2997603|Superiority|||||||0.821|||||||t-test, 1 sided||||
1631677|NCT02085447|2997604|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1631678|NCT02085447|2997605|Superiority|||||||0.053|||||||t-test, 1 sided||||
1631679|NCT02085447|2997606|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1631680|NCT02085447|2997607|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1631681|NCT02085447|2997608|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1631682|NCT02085447|2997609|Superiority|||||||0.197|||||||t-test, 1 sided||||
1631683|NCT02085447|2997610|Superiority||||||<|0.001|||||||t-test, 1 sided||||
1631684|NCT02085447|2997611|Superiority|||||||0.005|||||||t-test, 1 sided||||
1631685|NCT02085447|2997612|Superiority|||||||0.021|||||||t-test, 1 sided||||
1631686|NCT02085447|2997613|Superiority|||||||0.162|||||||t-test, 1 sided||||
1631687|NCT02085447|2997614|Superiority|||||||0.028|||||||t-test, 1 sided||||
1631688|NCT02085447|2997615|Superiority|||||||0.012|||||||t-test, 1 sided||||
1631689|NCT02085356|2997616|Other||Odds Ratio (OR)|0.32||||0.982|2-Sided||||||Mixed Models Analysis||||
1631690|NCT02085356|2997616|Other|||||||0.869|||||||Mixed Models Analysis||||
1631691|NCT02085356|2997617|Other|||||||0.902|||||||Chi-squared|||Attendance records could not be retrieved for most participants. However, this analysis was still conducted among those participants who had data.|
1631692|NCT02085356|2997618|Other|||||||0.605|||||||Mixed Models Analysis||||
1631693|NCT02085356|2997619|Other||Odds Ratio (OR)|0.32|||||2-Sided||||||||||
1631694|NCT02085356|2997620|Other||Odds Ratio (OR)|1.12|||||2-Sided||||||||||
1631695|NCT02085252|2997628|Superiority or Other|||||||0.0318||||||A 2-sided significance level of 5% was used. There was no adjustment for multiple comparisons.|Chi-squared|||The null hypothesis was that there was no difference between the two treatment strategies.|
1631696|NCT02085161|2997629|Superiority or Other||LSMean Difference|0.128|Standard Error of the Mean|0.069||0.0642|2-Sided|95.0|-0.008|0.263||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM||
1631697|NCT02085161|2997629|Superiority or Other||LSMean Difference|0.016|Standard Error of the Mean|0.068||0.815|2-Sided|95.0|-0.118|0.151||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM||
1631698|NCT02085161|2997629|Superiority or Other||LSMean Difference|0.174|Standard Error of the Mean|0.071||0.0145|2-Sided|95.0|0.035|0.314||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)||
1631699|NCT02085161|2997629|Superiority or Other||LSMean Difference|0.302|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|0.165|0.439||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)||
1631700|NCT02085161|2997629|Superiority or Other||LSMean Difference|0.318|Standard Error of the Mean|0.071|<|0.0001|2-Sided|95.0|0.179|0.457||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)||
1631701|NCT02085161|2997630|Superiority or Other||LSMean Difference|0.244|Standard Error of the Mean|0.064||0.0002|2-Sided|95.0|0.119|0.37||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM||
1631702|NCT02085161|2997630|Superiority or Other||LSMean Difference|-0.052|Standard Error of the Mean|0.063||0.4107|2-Sided|95.0|-0.176|0.072||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM||
1631703|NCT02085161|2997630|Superiority or Other||LSMean Difference|0.286|Standard Error of the Mean|0.066|<|0.0001|2-Sided|95.0|0.157|0.415||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)||
1631704|NCT02085161|2997630|Superiority or Other||LSMean Difference|0.53|Standard Error of the Mean|0.064|<|0.0001|2-Sided|95.0|0.403|0.657||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)||
1631705|NCT02085161|2997630|Superiority or Other||LSMean Difference|0.478|Standard Error of the Mean|0.065|<|0.0001|2-Sided|95.0|0.35|0.606||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)||
1631706|NCT02085161|2997631|Superiority or Other||LSMean Difference|0.182|Standard Error of the Mean|0.037|<|0.0001|2-Sided|95.0|0.109|0.255||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM||
1631707|NCT02085161|2997631|Superiority or Other||LSMean Difference|-0.027|Standard Error of the Mean|0.037|<|0.4677|2-Sided|95.0|-0.099|0.045||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM||
1631708|NCT02085161|2997631|Superiority or Other||LSMean Difference|0.174|Standard Error of the Mean|0.038|<|0.0001|2-Sided|95.0|0.099|0.249||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)||
1631709|NCT02085161|2997631|Superiority or Other||LSMean Difference|0.356|Standard Error of the Mean|0.037|<|0.0001|2-Sided|95.0|0.282|0.429||MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)||
1631710|NCT02085161|2997631|Superiority or Other||LSMean Difference|0.329|Standard Error of the Mean|0.038|<|0.0001|2-Sided|95.0|0.255|0.403||Mixed effect Model Repeat Measurement (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect|Mixed Models Analysis|Compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom|The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)||
1631711|NCT02085161|2997632|Superiority or Other||Treatment ratio|1.184|Standard Error of the Mean|0.123||0.1066|2-Sided|95.0|0.964|1.453||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM.||
1631712|NCT02085161|2997632|Superiority or Other||Treatment ratio|1.071|Standard Error of the Mean|0.111||0.5048|2-Sided|95.0|0.874|1.313||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM.||
1631713|NCT02085161|2997632|Superiority or Other||Treatment ratio|1.051|Standard Error of the Mean|0.113||0.6452|2-Sided|95.0|0.85|1.299||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM).||
1631784|NCT02082184|2997914|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.31|<|0.6075|2-Sided||||||ANCOVA|||Perceived frequency of hyperglycaemia|
1631714|NCT02085161|2997632|Superiority or Other||Treatment ratio|1.244|Standard Error of the Mean|0.131||0.039|2-Sided|95.0|1.011|1.53||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM).||
1631715|NCT02085161|2997632|Superiority or Other||Treatment ratio|1.333|Standard Error of the Mean|0.142||0.0077|2-Sided|95.0|1.08|1.645||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM).||
1631716|NCT02085161|2997633|Superiority or Other||LSMean Difference|0.128|Standard Error of the Mean|0.055||0.0203|2-Sided|95.0|0.02|0.236||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM||
1631717|NCT02085161|2997633|Superiority or Other||LSMean Difference|-0.067|Standard Error of the Mean|0.054||0.2183|2-Sided|95.0|-0.174|0.04||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM||
1631718|NCT02085161|2997633|Superiority or Other||LSMean Difference|0.016|Standard Error of the Mean|0.056||0.7815|2-Sided|95.0|-0.095|0.126||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)||
1631719|NCT02085161|2997633|Superiority or Other||LSMean Difference|0.143|Standard Error of the Mean|0.055||0.0097|2-Sided|95.0|0.035|0.252||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)||
1631720|NCT02085161|2997633|Superiority or Other||LSMean Difference|0.076|Standard Error of the Mean|0.056||0.1727|2-Sided|95.0|-0.034|0.187||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)||
1631721|NCT02085161|2997634|Superiority or Other||LSMean Difference|0.008|Standard Error of the Mean|0.004||0.0361|2-Sided|95.0|0.001|0.015||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM||
1631722|NCT02085161|2997634|Superiority or Other||LSMean Difference|-0.004|Standard Error of the Mean|0.004||0.2612|2-Sided|95.0|-0.011|0.003||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM||
1631723|NCT02085161|2997634|Superiority or Other||LSMean Difference|-0.006|Standard Error of the Mean|0.004||0.1081|2-Sided|95.0|-0.014|0.001||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)||
1631724|NCT02085161|2997634|Superiority or Other||LSMean Difference|0.002|Standard Error of the Mean|0.004||0.6436|2-Sided|95.0|-0.006|0.009||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)||
1631725|NCT02085161|2997634|Superiority or Other||LSMean Difference|-0.002|Standard Error of the Mean|0.004||0.5186|2-Sided|95.0|-0.01|0.005||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)||
1631726|NCT02085161|2997635|Superiority or Other||LSMean Difference|685.998|Standard Error of the Mean|289.435||0.0186|2-Sided|95.0|115.635|1256.362||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM||
1631727|NCT02085161|2997635|Superiority or Other||LSMean Difference|-493.048|Standard Error of the Mean|289.566||0.09|2-Sided|95.0|-1063.67|77.575||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM||
1631728|NCT02085161|2997635|Superiority or Other||LSMean Difference|-524.926|Standard Error of the Mean|296.802||0.0783|2-Sided|95.0|-1109.806|59.954||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM)||
1631729|NCT02085161|2997635|Superiority or Other||LSMean Difference|161.072|Standard Error of the Mean|293.506||0.5837|2-Sided|95.0|-417.314|739.459||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM)||
1631730|NCT02085161|2997635|Superiority or Other||LSMean Difference|-331.975|Standard Error of the Mean|296.375||0.2639|2-Sided|95.0|-916.015|252.064||An ANCOVA model with categorical effects of treatment and baseline as covariate.|ANCOVA||The LSMean Difference is calculated as Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM)||
1631731|NCT02085161|2997636|Superiority or Other||Treatment ratio|1.241|Standard Error of the Mean|0.123||0.0303|2-Sided|95.0|1.021|1.507||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Tiotropium (Tio) 5 micro-grams (μg) with BM.||
1631732|NCT02085161|2997636|Superiority or Other||Treatment ratio|1.128|Standard Error of the Mean|0.11||0.2188|2-Sided|95.0|0.931|1.368||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM.||
1631733|NCT02085161|2997636|Superiority or Other||Treatment ratio|1.041|Standard Error of the Mean|0.106||0.6895|2-Sided|95.0|0.853|1.272||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium (Tio) 5 micro-grams (μg) with BM minus Placebo with behavioural modification (BM).|This treatment comparison is the third one in the alpha-protected hierarchical testing chain. Since the p-value for this treatment comparison is >0.05, the hierarchical testing chain is broken and all of the following hypothesis tests in this hierarchical chain are considered as descriptive only.|
1631734|NCT02085161|2997636|Superiority or Other||Treatment ratio|1.292|Standard Error of the Mean|0.129||0.0109|2-Sided|95.0|1.061|1.573||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tiotropium + olodaterol (Olo) (5/5 μg) FDC with BM minus Placebo with behavioural modification (BM).|This treatment comparison is the second one in the alpha-protected hierarchical testing chain.|
1631735|NCT02085161|2997636|Superiority or Other||Treatment ratio|1.458|Standard Error of the Mean|0.147||0.0002|2-Sided|95.0|1.196|1.777||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was back transformed using the delta method.|Ratio of means calculated as back transformation of difference on log 10 scale between Tio+Olo (5/5 μg) FDC with exercise training (ET) and BM minus Placebo with behavioural modification (BM).|This treatment comparison is the first one in the alpha-protected hierarchical testing chain.|
1631736|NCT02084511|2997660|Superiority or Other|||||||0.0074|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.|
1631737|NCT02084511|2997660|Superiority or Other|||||||0.3093|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.|
1631738|NCT02084511|2997660|Superiority or Other|||||||0.415|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.|
1631739|NCT02084511|2997661|Superiority or Other|||||||0.0167|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.|
1631740|NCT02084511|2997661|Superiority or Other|||||||0.1851|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.|
1631741|NCT02084511|2997661|Superiority or Other|||||||0.2503|||||||Log Rank|||Log rank test used to evaluate the difference between each active treatment and placebo.|
1631742|NCT02084511|2997662|Superiority or Other||Mean Difference (Final Values)|1.37|||||2-Sided|95.0|-20.6|23.3|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with ’treatment’ as fixed effect, ’patient baseline pain intensity (BPI)’ as continuous covariate and the residual error term.|
1631743|NCT02084511|2997662|Superiority or Other||Mean Difference (Final Values)|-13.29|||||2-Sided|95.0|-35.2|8.6|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with ’treatment’ as fixed effect, ’patient baseline pain intensity (BPI)’ as continuous covariate and the residual error term.|
1631744|NCT02084511|2997662|Superiority or Other||Mean Difference (Final Values)|20.58|||||2-Sided|95.0|-1.3|42.5|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with ’treatment’ as fixed effect, ’patient baseline pain intensity (BPI)’ as continuous covariate and the residual error term.|
1631745|NCT02084511|2997662|Superiority or Other||Mean Difference (Final Values)|5.93|||||2-Sided|95.0|-16.0|27.8|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with ’treatment’ as fixed effect, ’patient baseline pain intensity (BPI)’ as continuous covariate and the residual error term.|
1631746|NCT02084511|2997663|Superiority or Other||Mean Difference (Final Values)|-6.98|||||2-Sided|95.0|-11.0|-2.9|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with ’treatment’ as fixed effect, ’patient baseline pain intensity (BPI)’ as continuous covariate and the residual error term.|
1631747|NCT02084511|2997663|Superiority or Other||Mean Difference (Final Values)|-6.27|||||2-Sided|95.0|-10.3|-2.2|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with ’treatment’ as fixed effect, ’patient baseline pain intensity (BPI)’ as continuous covariate and the residual error term.|
1631748|NCT02084511|2997663|Superiority or Other||Median Difference (Final Values)|0.98|||||2-Sided|95.0|-3.0|5.0|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with ’treatment’ as fixed effect, ’patient baseline pain intensity (BPI)’ as continuous covariate and the residual error term.|
1631749|NCT02084511|2997663|Superiority or Other||Mean Difference (Final Values)|1.7|||||2-Sided|95.0|-2.3|5.7|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with ’treatment’ as fixed effect, ’patient baseline pain intensity (BPI)’ as continuous covariate and the residual error term.|
1631750|NCT02084511|2997664|Superiority or Other||Mean Difference (Final Values)|-148.53|||||2-Sided|95.0|-252.4|-44.7|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with ’treatment’ as fixed effect, ’patient baseline pain intensity (BPI)’ as continuous covariate and the residual error term.|
1631751|NCT02084511|2997664|Superiority or Other||Mean Difference (Final Values)|-174.61|||||2-Sided|95.0|-278.3|-70.9|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with ’treatment’ as fixed effect, ’patient baseline pain intensity (BPI)’ as continuous covariate and the residual error term.|
1631785|NCT02082184|2997917|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.46||0.8729|2-Sided||||||ANCOVA|||Statistical analysis of time spent >240 mg/dL|
1631752|NCT02084511|2997664|Superiority or Other||Mean Difference (Final Values)|53.48|||||2-Sided|95.0|-50.2|157.1|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with ’treatment’ as fixed effect, ’patient baseline pain intensity (BPI)’ as continuous covariate and the residual error term.|
1631753|NCT02084511|2997664|Superiority or Other||Mean Difference (Final Values)|27.39|||||2-Sided|95.0|-76.3|131.1|||||Mean difference (final values) is actually the Least square mean|ANCOVA model was used with ’treatment’ as fixed effect, ’patient baseline pain intensity (BPI)’ as continuous covariate and the residual error term.|
1631754|NCT02084238|2997669|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Comparing the data between baseline and week 10.|
1631755|NCT02084082|2997679|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.18|Standard Error of the Mean|1.03|<|0.0001|2-Sided|90.0|93.34|103.27|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1000_fed / L+M 1000 fed)||
1631756|NCT02084082|2997679|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.11|Standard Error of the Mean|1.04|<|0.0001|2-Sided|90.0|92.37|106.35|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1000_fasted/ L+M 1000 fasted)||
1631757|NCT02084082|2997680|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.36|Standard Error of the Mean|1.132||0.0778|2-Sided|90.0|77.082|122.963|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1000_fed / L+M 1000 fed)||
1631758|NCT02084082|2997680|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.72|Standard Error of the Mean|1.028|<|0.0001|2-Sided|90.0|95.163|104.493|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1000_fasted/ L+M 1000 fasted)||
1631759|NCT02084082|2997681|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.97|Standard Error of the Mean|1.023|<|0.0001|2-Sided|90.0|94.95|103.16|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1000_fed / L+M 1000 fed)||
1631760|NCT02084082|2997681|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|99.77|Standard Error of the Mean|1.046|<|0.0001|2-Sided|90.0|92.464|107.645|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1000_fasted/ L+M 1000 fasted)||
1631761|NCT02084082|2997682|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.95|Standard Error of the Mean|1.03|<|0.0001|2-Sided|90.0|92.24|101.89|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1000_fed / L+M 1000 fed)||
1631762|NCT02084082|2997682|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|99.99|Standard Error of the Mean|1.04|<|0.0001|2-Sided|90.0|93.03|107.47|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1000_fasted/ L+M 1000 fasted)||
1631763|NCT02084082|2997683|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.24|Standard Error of the Mean|1.024|<|0.0001|2-Sided|90.0|94.067|102.597|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1000_fed / L+M 1000 fed)||
1631764|NCT02084082|2997683|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Mean ratio|108.09|Standard Error of the Mean|1.054|<|0.0038|2-Sided|90.0|99.022|117.989|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1000_fasted/ L+M 1000 fasted)||
1631765|NCT02084082|2997684|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio (net)|94.7|Standard Error of the Mean|1.037||0.0004|2-Sided|90.0|88.712|101.089|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1000 Fed/ L+M 1000 Fed)||
1631766|NCT02084082|2997684|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|100.37|Standard Error of the Mean|1.023|<|0.0001|2-Sided|90.0|96.562|104.326|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 1000_fasted/ L+M 1000 fasted)||
1632273|NCT02072174|2998871|Superiority|||||||0.0001|||||||Mixed Models Analysis||||
1631767|NCT02084056|2997686|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.19|Standard Error of the Mean|1.05||0.0002|2-Sided|90.0|90.73|106.27|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 2000 fed/ L+M 2000 fed)||
1631768|NCT02084056|2997686|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|95.49|Standard Error of the Mean|1.04|<|0.0001|2-Sided|90.0|89.73|101.62|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)||
1631769|NCT02084056|2997687|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.35|Standard Error of the Mean|1.062||0.0019|2-Sided|90.0|91.13|112.708|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 2000 fed/ L+M 2000 fed)||
1631770|NCT02084056|2997687|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|103.48|Standard Error of the Mean|1.03|<|0.0001|2-Sided|90.0|98.426|108.79|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)||
1631771|NCT02084056|2997688|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|105.85|Standard Error of the Mean|1.053||0.003|2-Sided|90.0|96.705|115.861|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 2000 fed/ L+M 2000 fed)||
1631772|NCT02084056|2997688|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.96|Standard Error of the Mean|1.038|<|0.0001|2-Sided|90.0|92.046|104.257|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)||
1631773|NCT02084056|2997689|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|97.75|Standard Error of the Mean|1.04||0.0002|2-Sided|90.0|90.47|105.63|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 2000 fed/ L+M 2000 fed)||
1631774|NCT02084056|2997689|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|96.45|Standard Error of the Mean|1.03|<|0.0001|2-Sided|90.0|91.23|101.97|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)||
1631775|NCT02084056|2997690|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|98.28|Standard Error of the Mean|1.075||0.0064|2-Sided|90.0|86.543|111.609|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 2000 fed/ L+M 2000 fed)||
1631776|NCT02084056|2997690|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|114.58|Standard Error of the Mean|1.038||0.0113|2-Sided|90.0|107.687|121.908|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)||
1631777|NCT02084056|2997691|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|101.63|Standard Error of the Mean|1.047||0.0003|2-Sided|90.0|93.721|110.202|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’.|Ratio of (FDC 2000 fed/ L+M 2000 fed)||
1631778|NCT02084056|2997691|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratios of the geometric means (FDC/free combination) using an acceptance range of 80.00 to 125.00%.|Adjusted Geometric Means ratio|103.68|Standard Error of the Mean|1.018|<|0.0001|2-Sided|90.0|100.703|106.747|||ANOVA|ANOVA on the logarithmic scale including effects for ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’|Ratio of (FDC 2000 fasted/ L+M 2000 fasted)||
1631779|NCT02082912|2997854|Superiority||F statistic|0.557||||0.471|2-Sided||||||ANOVA|||Values represent the time x treatment group interaction.|
1631780|NCT02082912|2997855|Superiority||F statistic|0.633||||0.447|2-Sided||||||ANOVA|||Values represent the time x treatment group interaction.|
1631781|NCT02082912|2997856|Superiority||F statistic|0.216||||0.651|2-Sided||||||ANOVA|||Values represent the time x treatment group interaction.|
1631782|NCT02082184|2997914|Superiority or Other||Mean Difference (Final Values)|4.1|Standard Error of the Mean|0.8|<|0.001|2-Sided||||||ANCOVA|||Total treatment satisfaction score|
1631783|NCT02082184|2997914|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.26|<|0.2295|2-Sided||||||ANCOVA|||Perceived frequency of hypoglycaemia|
1631787|NCT02082184|2997918|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.037||0.0017|2-Sided||||||ANCOVA|||Statistical analysis of frequency of episodes <55 mg/dL|
1631788|NCT02082184|2997918|Superiority or Other||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.065||0.0164|2-Sided||||||ANCOVA|||Statistical analysis of frequency of episodes <70 mg/dL|
1631789|NCT02082184|2997919|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.068||0.0014|2-Sided||||||ANCOVA|||Statistical analysis of time spent <55 mg/dL|
1631790|NCT02082184|2997919|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.134|<|0.001|2-Sided||||||ANCOVA|||Statistical analysis of time spent <70 mg/dL|
1631791|NCT02082184|2997920|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.58||0.7925|2-Sided||||||ANCOVA||||
1631792|NCT02082184|2997921|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.114||0.8222|2-Sided||||||ANCOVA||||
1631793|NCT02081859|2997931|Other|||||||0.21|||||||Chi-squared||||
1631794|NCT02081859|2997932|Other|||||||0.41|||||||Chi-squared||||
1631795|NCT02081846|2997933|Superiority|||||||0.12|||||||Regression, Logistic||||
1631796|NCT02081846|2997934|Superiority|||||||0.052|||||||Regression, Logistic||||
1631797|NCT02081846|2997935|Superiority|||||||0.08|||||||Regression, Logistic||||
1631798|NCT02081846|2997936|Superiority||||||<|0.01|||||||Poisson model||||
1631799|NCT02081846|2997937|Superiority|||||||0.82|||||||censored Poisson model||||
1631800|NCT02081846|2997938|Superiority|||||||0.32|||||||Regression, Linear||||
1631801|NCT02081846|2997939|Superiority|||||||0.047|||||||Regression, Logistic||||
1631802|NCT02081807|2997940|Other||Hazard Ratio (HR)|0.42|||||2-Sided|95.0|0.24|0.73||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631803|NCT02081807|2997940|Other||Hazard Ratio (HR)|0.79|||||2-Sided|95.0|0.6|1.05||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631804|NCT02081807|2997940|Other||Hazard Ratio (HR)|0.7|||||2-Sided|95.0|0.47|1.04||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Dabigatran vs. Warfarin (as reference group).|
1631805|NCT02081807|2997941|Other||Hazard Ratio (HR)|0.6|||||2-Sided|95.0|0.39|0.92||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631806|NCT02081807|2997941|Other||Hazard Ratio (HR)|0.82|||||2-Sided|95.0|0.65|1.04||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631807|NCT02081807|2997941|Other||Hazard Ratio (HR)|0.65|||||2-Sided|95.0|0.47|0.88||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631808|NCT02081807|2997942|Other||Hazard Ratio (HR)|0.53|||||2-Sided|95.0|0.37|0.76||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631809|NCT02081807|2997942|Other||Hazard Ratio (HR)|0.84|||||2-Sided|95.0|0.69|1.01||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Rivaroxaban vs. Warfarin (as reference group).|
1631810|NCT02081807|2997942|Other||Hazard Ratio (HR)|0.65|||||2-Sided|95.0|0.5|0.84||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631811|NCT02081807|2997943|Other||Hazard Ratio (HR)|0.79|||||2-Sided|95.0|0.53|1.18||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631812|NCT02081807|2997943|Other||Hazard Ratio (HR)|0.85|||||2-Sided|95.0|0.63|1.14||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631813|NCT02081807|2997943|Other||Hazard Ratio (HR)|0.83|||||2-Sided|95.0|0.6|1.15||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631814|NCT02081807|2997944|Other||Hazard Ratio (HR)|0.76|||||2-Sided|95.0|0.41|1.42||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631815|NCT02081807|2997944|Other||Hazard Ratio (HR)|0.84|||||2-Sided|95.0|0.55|1.29||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631816|NCT02081807|2997944|Other||Hazard Ratio (HR)|0.53|||||2-Sided|95.0|0.34|0.82||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631817|NCT02081807|2997945|Other||Hazard Ratio (HR)|0.56|||||2-Sided|95.0|0.47|0.67||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631818|NCT02081807|2997945|Other||Hazard Ratio (HR)|1.04|||||2-Sided|95.0|0.93|1.16||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631819|NCT02081807|2997945|Other||Hazard Ratio (HR)|0.68|||||2-Sided|95.0|0.59|78.0||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631820|NCT02081807|2997947|Other||Hazard Ratio (HR)|0.54|||||2-Sided|95.0|0.44|0.67||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631821|NCT02081807|2997947|Other||Hazard Ratio (HR)|1.19|||||2-Sided|95.0|1.05|1.35||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631822|NCT02081807|2997947|Other||Hazard Ratio (HR)|0.93|||||2-Sided|95.0|0.79|1.08||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631823|NCT02081807|2997948|Other||Hazard Ratio (HR)|0.79|||||2-Sided|95.0|0.54|1.14||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631824|NCT02081807|2997948|Other||Hazard Ratio (HR)|1.24|||||2-Sided|95.0|0.98|1.57||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631825|NCT02081807|2997948|Other||Hazard Ratio (HR)|0.6|||||2-Sided|95.0|0.44|0.8||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631826|NCT02081807|2997949|Other||Hazard Ratio (HR)|0.59|||||2-Sided|95.0|0.48|0.72||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631827|NCT02081807|2997949|Other||Hazard Ratio (HR)|1.21|||||2-Sided|95.0|1.07|1.36||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631828|NCT02081807|2997949|Other||Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.77|1.04||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631829|NCT02081807|2997950|Other||Hazard Ratio (HR)|0.54|||||2-Sided|95.0|0.47|0.63||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631830|NCT02081807|2997950|Other||Hazard Ratio (HR)|1.06|||||2-Sided|95.0|0.97|1.16||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631831|NCT02081807|2997950|Other||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.67|0.84||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631832|NCT02081807|2997951|Other||Hazard Ratio (HR)|0.67|||||2-Sided|95.0|0.43|1.03||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631833|NCT02081807|2997951|Other||Hazard Ratio (HR)|0.7|||||2-Sided|95.0|0.51|0.95||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631834|NCT02081807|2997951|Other||Hazard Ratio (HR)|0.39|||||2-Sided|95.0|0.25|0.59||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631835|NCT02081807|2997953|Other||Hazard Ratio (HR)|0.85|||||2-Sided|95.0|0.38|1.87||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631836|NCT02081807|2997953|Other||Hazard Ratio (HR)|1.0|||||2-Sided|95.0|0.58|1.72||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631837|NCT02081807|2997953|Other||Hazard Ratio (HR)|0.37|||||2-Sided|95.0|0.18|0.78||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631838|NCT02081807|2997954|Other||Hazard Ratio (HR)|0.65|||||2-Sided|95.0|0.45|0.94||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631839|NCT02081807|2997954|Other||Hazard Ratio (HR)|0.74|||||2-Sided|95.0|0.57|0.96||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631840|NCT02081807|2997954|Other||Hazard Ratio (HR)|0.84|||||2-Sided|95.0|0.63|1.12||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631841|NCT02081807|2997955|Other||Hazard Ratio (HR)|0.31|||||2-Sided|95.0|0.1|0.96||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631842|NCT02081807|2997955|Other||Hazard Ratio (HR)|1.05|||||2-Sided|95.0|0.65|1.71||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631843|NCT02081807|2997955|Other||Hazard Ratio (HR)|1.85|||||2-Sided|95.0|1.03|3.3||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631844|NCT02081807|2997956|Other||Hazard Ratio (HR)|0.64|||||2-Sided|95.0|0.47|0.88||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631845|NCT02081807|2997956|Other||Hazard Ratio (HR)|0.82|||||2-Sided|95.0|0.66|1.02||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631846|NCT02081807|2997956|Other||Hazard Ratio (HR)|0.87|||||2-Sided|95.0|0.69|1.11||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631847|NCT02081807|2997957|Other||Hazard Ratio (HR)|0.56|||||2-Sided|95.0|0.49|0.64||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631848|NCT02081807|2997957|Other||Hazard Ratio (HR)|0.58|||||2-Sided|95.0|0.49|0.68||||||MarketScan-Apixaban vs. Warfarin (as reference group).|
1631849|NCT02081807|2997957|Other||Hazard Ratio (HR)|0.51|||||2-Sided|95.0|0.39|0.66||||||Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631850|NCT02081807|2997957|Other||Hazard Ratio (HR)|1.02|||||2-Sided|95.0|0.94|1.12||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631853|NCT02081807|2997957|Other||Hazard Ratio (HR)|0.72|||||2-Sided|95.0|0.65|0.8||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631854|NCT02081807|2997957|Other||Hazard Ratio (HR)|0.76|||||2-Sided|95.0|0.68|0.86||||||MarketScan-Dabigatran vs. Warfarin (as reference group).|
1631855|NCT02081807|2997957|Other||Hazard Ratio (HR)|0.51|||||2-Sided|95.0|0.38|0.69||||||Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631856|NCT02081807|2997958|Other||Hazard Ratio (HR)|0.69|||||2-Sided|95.0|0.5|0.96||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631857|NCT02081807|2997958|Other||Hazard Ratio (HR)|0.58|||||2-Sided|95.0|0.38|0.89||||||MarketScan-Apixaban vs. Warfarin (as reference group).|
1631858|NCT02081807|2997958|Other||Hazard Ratio (HR)|0.9|||||2-Sided|95.0|0.53|1.51||||||Optum Clinformatic- Apixaban vs. Warfarin (as reference group).|
1631859|NCT02081807|2997958|Other||Hazard Ratio (HR)|0.77|||||2-Sided|95.0|0.61|0.98||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631860|NCT02081807|2997958|Other||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.57|0.98||||||MarketScan-Rivaroxaban vs. Warfarin (as reference group).|
1631861|NCT02081807|2997958|Other||Hazard Ratio (HR)|0.84|||||2-Sided|95.0|0.53|1.35||||||Optum Clinformatic- Rivaroxaban vs. Warfarin (as reference group).|
1631862|NCT02081807|2997958|Other||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.58|0.98||||||This is a pooled analysis involving data from both MarketScan and Optum databases. MarketScan and Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631863|NCT02081807|2997958|Other||Hazard Ratio (HR)|0.69|||||2-Sided|95.0|0.52|0.94||||||MarketScan-Dabigatran vs. Warfarin (as reference group).|
1631864|NCT02081807|2997958|Other||Hazard Ratio (HR)|1.0|||||2-Sided|95.0|0.57|1.76||||||Optum Clinformatic-Dabigatran vs. Warfarin (as reference group).|
1631865|NCT02081417|2998011|Non-Inferiority|Based on the PCL-C if the interventions fell within 2.5 points of each other|Mean Difference (Net)|0.18||||0.01|2-Sided|95.0|-3.4|3.8|||Mixed Models Analysis||||
1631866|NCT02081391|2998026|Superiority||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.04||0.0154|2-Sided|95.0|-0.18|-0.02|||ANOVA|||The endpoint was analyzed using an analysis of variance model. This included treatment, baseline age group, and the used supplemental opioid analgesic medication (SOAM) as factors. For participants discontinuing treatment before 24 hours for any other reason than no further need of SOAM or switch to exclusively oral opioid analgesics, cumulative SOAM use over the respective time period was based on the observed SOAM use up to the time of the participant’s discontinuation.|
1631867|NCT02081391|2998027|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.02||0.0404|2-Sided|95.0|-0.09|0.0|||ANOVA|||The endpoint was analyzed using an analysis of variance model. This included treatment, baseline age group, and the used SOAM as factors. For participants discontinuing treatment before 12 hours for any other reason than no further need of opioid analgesics or switch to exclusively oral opioid analgesics, cumulative SOAM use over the respective time period was based on the observed SOAM use up to the time of the participant’s discontinuation.|
1631868|NCT02081365|2998028|Superiority or Other||Mean Difference (Final Values)|0.82|||<|0.05|2-Sided|95.0|0.01|1.64|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate|
1631869|NCT02081365|2998029|Superiority or Other||Mean Difference (Final Values)|1.23|||<|0.05|2-Sided|95.0|0.61|1.85|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate|
1631870|NCT02081365|2998030|Superiority or Other||Mean Difference (Final Values)|0.98|||<|0.05|2-Sided|95.0|0.39|1.57|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate|
1631871|NCT02081365|2998031|Superiority or Other||Mean Difference (Final Values)|2.2|||<|0.05|2-Sided|95.0|0.74|3.55|||ANCOVA|||Comparison of two groups at 1 month follow up with baseline value as the covariate|
1631872|NCT02081248|2998032|Superiority|||||||0.26||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1301 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1501 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.|
1631873|NCT02081248|2998032|Superiority|||||||0.69||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1203 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1203 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.|
1631874|NCT02081248|2998032|Superiority|||||||0.77||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 1101 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 1101 were compared between arms in participants considering enrollment, which should be approximately equal under the null hypothesis.|
1631875|NCT02081248|2998032|Superiority|||||||1||||||Testing was performed at a significance level of 0.05|Fisher Exact|||The null hypothesis is that there is no difference in the consent rates to BMT CTN 0901 between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Consent rates to BMT CTN 0901 were compared between arms in participants considering enrollment, which should be equal under the null hypothesis.|
1631876|NCT02081248|2998033|Superiority|||||||0.79||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find study procedures between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find study procedures was compared between arms, which should be equal under the null hypothesis.|
1631901|NCT02081014|2998054|Superiority or Other||Point estimate ratio|0.96|Standard Error of the Mean|0.08|>|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631902|NCT02081014|2998055|Superiority or Other||Point estimate ratio|0.85|Standard Error of the Mean|0.06|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631877|NCT02081248|2998033|Superiority|||||||0.56||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find how to leave the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find how to leave the study was compared between arms, which should be equal under the null hypothesis.|
1631878|NCT02081248|2998033|Superiority|||||||0.74||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find the risks and benefits section between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the risks and benefits section was compared between arms, which should be equal under the null hypothesis.|
1631879|NCT02081248|2998033|Superiority|||||||0.26||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find who to contact for questions between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find who to contact for questions was compared between arms, which should be equal under the null hypothesis.|
1631880|NCT02081248|2998033|Superiority|||||||0.73||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in the time required to find the main goal of the study between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median time required to find the main goal of the study was compared between arms, which should be equal under the null hypothesis.|
1631881|NCT02081248|2998034|Superiority|||||||0.8||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in satisfaction with the consent process, as measured by a study-specific questionnaire, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median participant satisfaction scores were compared between arms, which should be equal under the null hypothesis.|
1631882|NCT02081248|2998035|Superiority|||||||0.25||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' trait anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median trait anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.|
1631883|NCT02081248|2998035|Superiority|||||||0.21||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' state anxiety, as measured by the STAI, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median state anxiety subscores of the STAI were compared between arms, which should be equal under the null hypothesis.|
1631884|NCT02081248|2998038|Superiority|||||||0.17||||||Testing was performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' comprehension of the parent clinical trial, as measured by the DICCT, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median DICCT scores were compared between arms, which should be approximately equal under the null hypothesis.|
1631885|NCT02081248|2998039|Superiority|||||||0.39||||||Testing performed at a significance level of 0.05|Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in participants' perception of their comprehension of the parent clinical trial, as measured by the QuIC-B, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Median QuIC-B scores were compared between arms, which should be approximately equal under the null hypothesis.|
1631886|NCT02081248|2998040|Superiority|||||||0.37||||||Testing was performed at a significance level of 0.05|t-test, 2 sided|Two-sample t-test comparing mean QuIC-A scores performed using 150 degrees of freedom||The null hypothesis is that there is no difference in comprehension of the parent clinical trial, as measured by the QuIC-A, between participants reviewing a standard consent and easy-to-read informed consent (ETRIC) forms. Mean QuIC-A scores were compared between arms, which should be approximately equal under the null hypothesis.|
1631887|NCT02081014|2998050|Superiority or Other||Point estimate ratio|3.23|Standard Error of the Mean|3.84|>|0.05|2-Sided||||||Regression, Linear||Geometric means||
1631888|NCT02081014|2998050|Superiority or Other||Point estimate ratio|0.73|Standard Error of the Mean|0.88|>|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631889|NCT02081014|2998050|Superiority or Other||Point estimate ratio|0.23|Standard Error of the Mean|0.29|>|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631890|NCT02081014|2998051|Superiority or Other||Point estimate ratio|1.05|Standard Error of the Mean|0.81|>|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631891|NCT02081014|2998051|Superiority or Other||Point estimate ratio|0.43|Standard Error of the Mean|0.34|>|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631892|NCT02081014|2998051|Superiority or Other||Point estimate ratio|0.41|Standard Error of the Mean|0.32|>|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631893|NCT02081014|2998052|Superiority or Other||Mean Difference (Final Values)|-1520.39|Standard Error of the Mean|700.92|>|0.05|2-Sided||||||Mixed Models Analysis||||
1631894|NCT02081014|2998052|Superiority or Other||Mean Difference (Final Values)|-1665.32|Standard Error of the Mean|696.97|<|0.05|2-Sided||||||Mixed Models Analysis||||
1631895|NCT02081014|2998052|Superiority or Other||Mean Difference (Final Values)|-144.9|Standard Error of the Mean|741.24|>|0.05|2-Sided||||||Mixed Models Analysis||||
1631896|NCT02081014|2998053|Superiority or Other||Mean Difference (Final Values)|-3854.86|Standard Error of the Mean|1533.95|<|0.05|2-Sided||||||Mixed Models Analysis||||
1631897|NCT02081014|2998053|Superiority or Other||Mean Difference (Final Values)|-7548.05|Standard Error of the Mean|1542.93|<|0.05|2-Sided||||||Mixed Models Analysis||||
1631898|NCT02081014|2998053|Superiority or Other||Mean Difference (Final Values)|-3693.2|Standard Error of the Mean|1520.1|<|0.05|2-Sided||||||Mixed Models Analysis||||
1631899|NCT02081014|2998054|Superiority or Other||Point estimate ratio|0.86|Standard Error of the Mean|0.06|>|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631900|NCT02081014|2998054|Superiority or Other||Point estimate ratio|0.83|Standard Error of the Mean|0.06|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631903|NCT02081014|2998055|Superiority or Other||Point estimate ratio|0.7|Standard Error of the Mean|0.05|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631904|NCT02081014|2998055|Superiority or Other||Point estimate ratio|0.82|Standard Error of the Mean|0.06|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631905|NCT02081014|2998056|Superiority or Other||Point estimate ratio|0.96|Standard Error of the Mean|0.13|>|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631906|NCT02081014|2998056|Superiority or Other||Point estimate ratio|0.73|Standard Error of the Mean|0.1|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631907|NCT02081014|2998056|Superiority or Other||Point estimate ratio|0.75|Standard Error of the Mean|0.1|>|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631908|NCT02081014|2998057|Superiority or Other||Point estimate ratio|0.79|Standard Error of the Mean|0.11|>|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631909|NCT02081014|2998057|Superiority or Other||Point estimate ratio|0.78|Standard Error of the Mean|0.11|>|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631910|NCT02081014|2998057|Superiority or Other||Point esimate ratio|0.98|Standard Error of the Mean|0.14|>|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631911|NCT02081014|2998058|Superiority or Other||Point estimate ratio|0.6|Standard Error of the Mean|0.03|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631912|NCT02081014|2998058|Superiority or Other||Point estimate ratio|0.44|Standard Error of the Mean|0.02|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631913|NCT02081014|2998058|Superiority or Other||Point estimate ratio|0.72|Standard Error of the Mean|0.04|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631914|NCT02081014|2998059|Superiority or Other||Point estimate ratio|0.53|Standard Error of the Mean|0.04|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631915|NCT02081014|2998059|Superiority or Other||Point estimate ratio|0.36|Standard Error of the Mean|0.03|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631916|NCT02081014|2998059|Superiority or Other||Point point ratio|0.68|Standard Error of the Mean|0.05|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631917|NCT02081014|2998060|Superiority or Other||Point estimate ratio|0.59|Standard Error of the Mean|0.05|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631918|NCT02081014|2998060|Superiority or Other||Point estimate ratio|0.44|Standard Error of the Mean|0.04|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631919|NCT02081014|2998060|Superiority or Other||Point estimate ratio|0.74|Standard Error of the Mean|0.06|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631920|NCT02081014|2998061|Superiority or Other||Point estimate ratio|0.57|Standard Error of the Mean|0.06|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631921|NCT02081014|2998061|Superiority or Other||Point estimate ratio|0.35|Standard Error of the Mean|0.04|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631922|NCT02081014|2998061|Superiority or Other||Point estimate ratio|0.62|Standard Error of the Mean|0.07|<|0.05|2-Sided||||||Mixed Models Analysis||Geometric means||
1631923|NCT02081001|2998063|Superiority or Other||Mean Difference (Net)|-3.6|Standard Error of the Mean|1.6||0.03|2-Sided|95.0|-6.7|-0.4|||Mixed Models Analysis||||
1631924|NCT02081001|2998063|Superiority or Other||Mean Difference (Net)|-0.9|Standard Error of the Mean|1.6||0.58|2-Sided|95.0|-4.0|2.3|||Mixed Models Analysis||||
1631925|NCT02081001|2998063|Superiority or Other||Mean Difference (Net)|-2.0|Standard Error of the Mean|1.6||0.22|2-Sided|95.0|-5.1|1.2|||Mixed Models Analysis||||
1631926|NCT02081001|2998064|Superiority or Other||Mean Difference (Net)|-23.3|Standard Error of the Mean|5.4|<|0.0001|2-Sided|95.0|-34.0|-12.6|||Mixed Models Analysis||||
1631927|NCT02081001|2998064|Superiority or Other||Mean Difference (Final Values)|-19.4|Standard Error of the Mean|5.4|<|0.0005|2-Sided|95.0|-30.1|-8.7|||Mixed Models Analysis||||
1631928|NCT02081001|2998064|Superiority or Other||Mean Difference (Final Values)|-6.4|Standard Error of the Mean|5.4|<|0.24|2-Sided|95.0|-17.1|4.3|||Mixed Models Analysis||||
1631929|NCT02081001|2998065|Superiority or Other||Point estimate ratio|1.13|Standard Error of the Mean|0.1||0.19|2-Sided|90.0|0.97|1.31|||Mixed Models Analysis||||
1631930|NCT02081001|2998065|Superiority or Other||Point estimate ratio|1.15|Standard Error of the Mean|0.12||0.21|2-Sided|90.0|0.95|1.38|||Regression, Cox||||
1631931|NCT02081001|2998065|Superiority or Other||Point estimate ratio|1.18|Standard Error of the Mean|0.14||0.19|2-Sided|90.0|0.96|1.46|||Mixed Models Analysis||||
1631932|NCT02081001|2998066|Superiority or Other||Point estimate ratio|0.84|Standard Error of the Mean|0.12||0.26|2-Sided|90.0|0.66|1.09|||Mixed Models Analysis||||
1631933|NCT02081001|2998066|Superiority or Other||Point estimate ratio|1.19|Standard Error of the Mean|0.16||0.22|2-Sided|90.0|0.94|1.5|||Mixed Models Analysis||||
1631934|NCT02081001|2998066|Superiority or Other||Point estimate ratio|1.06|Standard Error of the Mean|0.12||0.61|2-Sided|90.0|0.87|1.3|||Mixed Models Analysis||||
1631935|NCT02081001|2998067|Superiority or Other||Point estimate ratio|0.8|Standard Error of the Mean|0.16||0.28|2-Sided|90.0|0.57|1.13|||Mixed Models Analysis||||
1631936|NCT02081001|2998067|Superiority or Other||Point estimate ratio|1.31|Standard Error of the Mean|0.49||0.48|2-Sided|90.0|0.68|2.54|||Mixed Models Analysis||||
1631937|NCT02081001|2998067|Superiority or Other||Point estimate ratio|2.02|Standard Error of the Mean|0.95||0.16|2-Sided|90.0|0.87|4.66|||Mixed Models Analysis||||
1631938|NCT02081001|2998068|Superiority or Other||Point estmate ratio|1.45|Standard Error of the Mean|0.26||0.052|2-Sided|90.0|1.07|1.98|||Mixed Models Analysis||||
1631939|NCT02081001|2998068|Superiority or Other||Point estimate ratio|1.26|Standard Error of the Mean|0.21||0.19|2-Sided|90.0|0.94|1.68|||Mixed Models Analysis||||
1631940|NCT02081001|2998068|Superiority or Other||Point estimate ratio|0.91|Standard Error of the Mean|0.22||0.7|2-Sided|90.0|0.6|1.38|||Mixed Models Analysis||||
1631941|NCT02081001|2998069|Superiority or Other||Point estimate ratio|1.11|Standard Error of the Mean|0.09||0.24|2-Sided|90.0|0.96|1.28|||Mixed Models Analysis||||
1632274|NCT02072174|2998872|Superiority|||||||0.0721|||||||Mixed Models Analysis||||
1631942|NCT02081001|2998069|Superiority or Other||Point estimate ratio|1.12|Standard Error of the Mean|0.12||0.29|2-Sided|90.0|0.93|1.35|||Mixed Models Analysis||||
1631943|NCT02081001|2998069|Superiority or Other||Point estimate ratio|1.18|Standard Error of the Mean|0.11||0.09|2-Sided|90.0|1.01|1.39|||Mixed Models Analysis||||
1631944|NCT02081001|2998070|Superiority or Other||Point estimate ratio|0.83|Standard Error of the Mean|0.15||0.31|2-Sided|90.0|0.6|1.14|||Mixed Models Analysis||||
1631945|NCT02081001|2998070|Superiority or Other||Point estimate ratio|1.29|Standard Error of the Mean|0.26||0.24|2-Sided|90.0|0.9|1.84|||Mixed Models Analysis||||
1631946|NCT02081001|2998070|Superiority or Other||Point estimate ratio|1.26|Standard Error of the Mean|0.19||0.15|2-Sided|90.0|0.97|1.64|||Mixed Models Analysis||||
1631947|NCT02081001|2998071|Superiority or Other||Point estimate ratio|1.36|Standard Error of the Mean|0.16||0.02|2-Sided|90.0|1.11|1.67|||Mixed Models Analysis||||
1631948|NCT02081001|2998071|Superiority or Other||Point estimate ratio|1.29|Standard Error of the Mean|0.18||0.09|2-Sided|90.0|1.01|1.65|||Mixed Models Analysis||||
1631949|NCT02081001|2998071|Superiority or Other||Point estimate ratio|1.37|Standard Error of the Mean|0.34||0.23|2-Sided|90.0|0.88|2.12|||Mixed Models Analysis||||
1631950|NCT02081001|2998072|Superiority or Other||Point estimate ratio|0.86|Standard Error of the Mean|0.19||0.49|2-Sided|90.0|0.59|1.25|||Mixed Models Analysis||||
1631951|NCT02081001|2998072|Superiority or Other||Point estimate ratio|1.25|Standard Error of the Mean|0.43||0.52|2-Sided|90.0|0.69|2.28|||Mixed Models Analysis||||
1631952|NCT02081001|2998072|Superiority or Other||Point estimate ratio|2.06|Standard Error of the Mean|1.19||0.23|2-Sided|90.0|0.74|5.75|||Mixed Models Analysis||||
1631953|NCT02080871|2998150|Other|This was a single-arm study designed to compare the primary outcome result to a performance goal based on published literature. The null hypothesis was the probability of a subject experiencing a Major Adverse Event (MAE) with use of study device is at least 17%. The alternate hypothesis was the probability of a subject experiencing a Major Adverse Event (MAE) with use of the study device is less than 17%.|||||<|0.001|||||||one-sided binomial exact test|||The sample size obtains over 90% power to statistically show the probability that a subject will experience an MAE with use of the study device is less than 17% when 12% or less of the subjects are lost to follow up prior to 9 months.|
1631954|NCT02080637|2998157|Other||Slope|1.2||||0.61|2-Sided|95.0|-3.9|6.3|||Regression, Linear||||
1631955|NCT02080637|2998158|Other||Slope|-27.0||||0.94|2-Sided|95.0|-775.0|723.0|||Regression, Linear||||
1631956|NCT02080637|2998159|Other||Mean Difference (Final Values)|-0.5|Standard Deviation|0.5||0.01|2-Sided||||||Paired t-test|||Baseline versus 2 hours post-ambrisentan|
1631957|NCT02080481|2998165|Superiority or Other||Mean Difference (Final Values)|4.4||||0.74|2-Sided|98.3|-7.7|14.6|||Regression, Linear|Intraoperative management strategy was imbalanced between randomized groups and adjusted for in the linear regression model.|||
1631958|NCT02080481|2998166|Superiority or Other||Odds Ratio (OR)|0.13||||0.06|2-Sided|98.3|0.01|1.78||Intraoperative management strategy was imbalanced between groups and adjusted for in the logistic regression model.|Regression, Logistic||||
1631959|NCT02080481|2998167|Superiority or Other||Odds Ratio (OR)|1.55||||0.56|2-Sided|98.3|0.25|9.6|||Regression, Logistic|intraoperative management strategy was imbalanced between randomized groups and was adjusted for in the logistic regression model.|Odds ratio for Infiniti Plus versus conventional needle patients||
1631960|NCT02080481|2998168|Superiority or Other||ratio of geometric means|0.68|||<|0.001|2-Sided|95.0|0.61|0.76|||Regression, Linear|intraoperative management strategy was imbalanced between randomized groups and was adjusted for in the linear regression model.|||
1631961|NCT02080273|2998192|Other|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.|
1631962|NCT02080273|2998193|Other|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.|
1631963|NCT02080273|2998194|Other|||||||0.848||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline|
1631964|NCT02080273|2998195|Other|||||||0.922|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.|
1631965|NCT02080273|2998196|Other|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.|
1631966|NCT02080273|2998197|Superiority or Other|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.|
1631967|NCT02080273|2998198|Superiority or Other|||||||0.001||||||1 factor ANCOVA to determine difference between groups with baseline as covariate. The F statistic is used to determine significance. If significance is found then a Tukey's multiple comparison is done.|ANCOVA|||The null hypothesis states that there is no difference between groups. ANCOVA adjusting for baseline.|
1631968|NCT02080273|2998199|Other|||||||0.919|||||||ANOVA|||Means and standard deviations. 1 factor ANOVA to balance treatment groups to show no difference between groups. The null hypothesis states that there is no difference between groups.|
1631969|NCT02080260|2998200|Other|Estimation only.|Disease Control Rate|0.3|||||2-Sided|95.0|0.119|0.543|||||Confidence interval estimated using the Clopper Pearson method.||
1632275|NCT02072174|2998873|Superiority|||||||0.0233|||||||Kruskal-Wallis|||Days 1, 3, 5 and 7 (doctor's examination)|
1631970|NCT02080260|2998201|Other|Estimation only|Overall Response Rate|0.05|||||2-Sided|95.0|0.001|0.249|||||Confidence interval estimated using the Clopper Pearson method.||
1631971|NCT02080260|2998202|Other|Estimation only.|Median|9.4|||||2-Sided|95.0|8.1|17.0|||||The Kaplan Meier method was used to estimate the median OS(in weeks) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.||
1631972|NCT02080260|2998203|Other|Estimation only.|Median|6.1|||||2-Sided|95.0|2.9|7.1|||||The Kaplan Meier method was used to estimate the median PFS(in weeks) for the population. The Greenwood method was used to estimate the confidence limits of the median progression free survival.||
1631973|NCT02080260|2998204|Superiority||16-week PFS Rate|0.1||||0.824|2-Sided|95.0|0.012|0.317||This p-value is only based on partial enrollment of the study. The study enrollment was stopped early due to futility.|Fisher Exact||Confidence interval estimated using the Clopper Pearson method.|The null hypothesis assumes a median PFS of 6 weeks, corresponding to a 16-week PFS rate of approximately 0.15. A single-stage design will be used to test that the 16-week PFS rate is less than or equal to 0.15. If at least 8 of the 32 subjects are alive and progression free at 16 weeks, the null hypothesis will be rejected. Assuming a one-sided alpha = 0.10 significance level, this will provide at least 90% power to reject the null hypothesis, assuming the true 16-week PFS rate is 0.35.|
1631974|NCT02079987|2998214|Superiority|||||||0.87|||||||Chi-squared||||
1631975|NCT02079987|2998215|Superiority|||||||0.57|||||||Chi-squared||||
1631976|NCT02079987|2998216|Superiority|||||||0.03|||||||Chi-squared||||
1631977|NCT02079987|2998217|Superiority|||||||0.25||||||A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.|difference-in-difference analysis||||
1631978|NCT02079987|2998218|Superiority|||||||0.23|||||||difference-in-difference analysis|A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.|||
1631979|NCT02079987|2998219|Superiority|||||||0.49|||||||difference-in-difference analysis|A propensity weighted difference-in-difference approach was taken to account for imbalances in assignment and loss to follow-up.|||
1631980|NCT02079909|2998220|Superiority||Mean Difference (Final Values)|1.29||||0.3212|2-Sided||||||Mixed Models Analysis||||
1631981|NCT02079909|2998221|Superiority||Mean Difference (Final Values)|0.04||||0.7588|2-Sided||||||Mixed Models Analysis||||
1631982|NCT02079909|2998222|Superiority||Mean Difference (Final Values)|-0.84||||0.3919|2-Sided||||||Mixed Models Analysis||||
1631983|NCT02079844|2998237|Superiority or Other||LS Mean Difference|-0.171|Standard Error of the Mean|0.1757||0.345|2-Sided|95.0|-1.193|0.571||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA||||
1631984|NCT02079844|2998237|Superiority or Other||LS Mean Difference|0.076|Standard Error of the Mean|0.1757||0.671|2-Sided|95.0|-0.739|0.106||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA||||
1631985|NCT02079844|2998238|Superiority or Other||LS Mean Difference|2.377|Standard Error of the Mean|1.2545||0.069|2-Sided|95.0|-0.198|4.951||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA||||
1631986|NCT02079844|2998238|Superiority or Other||LS Mean Difference|1.938|Standard Error of the Mean|1.2436||0.131|2-Sided|95.0|-0.614|4.49||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA||||
1631987|NCT02079844|2998239|Superiority or Other||LS Mean Difference|0.133|Standard Error of the Mean|0.7417||0.859|2-Sided|95.0|-1.389|1.655||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA||||
1631988|NCT02079844|2998239|Superiority or Other||LS Mean Difference|0.232|Standard Error of the Mean|0.7313||0.753|2-Sided|95.0|-1.269|1.733||P-values are from ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|ANOVA||||
1631989|NCT02079805|2998246|Superiority or Other||Mean Difference (Final Values)|0.44|||||2-Sided|95.0|-0.89|1.78||||||Telmisartan 40 mg, Azilsartan 20 mg|
1631990|NCT02079610|2998249|Superiority||Mean Difference (Final Values)|6.8|Standard Deviation|3.5||0.01|2-Sided||||||Mixed Models Analysis||||
1631991|NCT02079610|2998250|Superiority||Mean Difference (Final Values)|8.2|Standard Deviation|5.2||0.03|2-Sided||||||Mixed Models Analysis||||
1631992|NCT02079610|2998251|Superiority||Mean Difference (Final Values)|10.0|Standard Deviation|3.93|<|0.001|2-Sided||||||Mixed Models Analysis||||
1631993|NCT02078713|2998351|Superiority||Odds Ratio (OR)|1.83||||0.11|2-Sided|95.0|0.88|3.8||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment|
1631994|NCT02078713|2998351|Superiority||Odds Ratio (OR)|1.27||||0.63|2-Sided|95.0|0.48|3.37||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment|
1631995|NCT02078713|2998352|Superiority||Odds Ratio (OR)|1.17||||0.37|2-Sided|95.0|0.83|1.64||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment|
1632070|NCT02077374|2998392|Superiority or Other||Median Difference (Net)|-145.0||||0.1149|2-Sided|95.0|-336.0|55.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change for cCK18/M30 from Baseline to Day 28/ET between IDN-6556 and Placebo|
1632857|NCT02057757|3000269|Superiority|||||||0.16||||||Headache|Fay-Shaw||||
1631996|NCT02078713|2998352|Superiority||Odds Ratio (OR)|0.94||||0.75|2-Sided|95.0|0.66|1.34||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment|
1631997|NCT02078713|2998353|Superiority||Odds Ratio (OR)|1.07||||0.71|2-Sided|95.0|0.75|1.53||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment|
1631998|NCT02078713|2998353|Superiority||Odds Ratio (OR)|0.94||||0.75|2-Sided|95.0|0.66|1.35||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment|
1631999|NCT02078713|2998354|Superiority||Odds Ratio (OR)|1.06||||0.78|2-Sided|95.0|0.69|1.65||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.||
1632000|NCT02078713|2998355|Superiority||Slope|-1.64|Standard Error of the Mean|1.34||0.28|2-Sided|95.0|-4.61|1.34|||Regression, Linear||Tool group compared to control group (ref). Bootstrapping used for standard error.|Linear regression of follow-up score for personal accomplishment subscale of Maslach Burnout Inventory, controlling for site and baseline score.|
1632001|NCT02078713|2998355|Superiority||Observed coefficient|-1.52|Standard Error of the Mean|1.91||0.36|2-Sided|95.0|-4.76|1.72|||Regression, Linear||Tool group is compared to control group (ref). Bootstrapping used for standard error|Linear regression of follow-up score for depersonalization subscale of Maslach Burnout Inventory, controlling for baseline score and site.|
1632002|NCT02078713|2998355|Superiority||Observed coefficient|-3.97|Standard Error of the Mean|3.34||0.24|2-Sided|95.0|-10.62|2.68|||Regression, Linear||Tool group is compared to control group (ref). Bootstrapping used for standard error.|Test of follow-up score of emotional exhaustion subscale of Maslach Burnout Inventory, controlling for baseline score and site|
1632003|NCT02078713|2998356|Superiority||Mean Difference (Final Values)|1.05||||0.63|2-Sided|95.0|-3.19|5.29||P-value calculated in multiply imputed dataset|Regression, Linear|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation parameter is a beta coefficient from a linear regression model, calculated in an imputed dataset. It represents additional minutes in an intervention visit versus a control visit.||
1632004|NCT02078713|2998357|Superiority||Mean Difference (Final Values)|11.81|||<|0.001|2-Sided|95.0|8.54|18.66||P-value calculated in multiple imputed dataset|Regression, Linear|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation parameter is a beta coefficient from a linear regression model, calculated in an imputed dataset. It represents additional minutes in an intervention visit versus a control visit.||
1632005|NCT02078713|2998358|Superiority||Odds Ratio (OR)|1.27||||0.18|2-Sided|95.0|0.9|1.81||P-value calculated from multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|"The odds ratio represents the odds of the intervention group rating their appointment as much better, in the numerator, over the odds of the control group giving this rating in the denominator."|Patients excluded from test if they reported not having had a previous contraceptive counseling appointment.|
1632006|NCT02078713|2998359|Superiority||Odds Ratio (OR)|1.49||||0.39|2-Sided|95.0|0.6|3.73||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of female sterilization|
1632007|NCT02078713|2998359|Superiority||Odds Ratio (OR)|1.49||||0.39|2-Sided|95.0|0.6|3.73||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of male sterilization (vasectomy)|
1632008|NCT02078713|2998359|Superiority||Odds Ratio (OR)|1.38||||0.37|2-Sided|95.0|0.68|2.81||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of ring|
1632009|NCT02078713|2998359|Superiority||Odds Ratio (OR)|1.7||||0.32|2-Sided|95.0|0.59|4.89||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of the patch|
1632010|NCT02078713|2998359|Superiority||Odds Ratio (OR)|1.29||||0.5|2-Sided|95.0|0.62|2.69||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of implant|
1632099|NCT02075840|2998521|Superiority|IRC, RECIST v1.1 Stratified Analysis (by race (Asian vs non-Asian) and CNS metastases at baseline by IRC)|Cause-Specific Hazard Ratio|0.16|||<|0.0001|2-Sided|95.0|0.1|0.28|||Log Rank||||
1632011|NCT02078713|2998359|Superiority||Odds Ratio (OR)|1.65||||0.18|2-Sided|95.0|0.8|3.4||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of non-hormonal IUD|
1632012|NCT02078713|2998359|Superiority||Odds Ratio (OR)|1.55||||0.27|2-Sided|95.0|0.71|3.42||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of patients who newly heard of hormonal IUD|
1632013|NCT02078713|2998360|Superiority||Odds Ratio (OR)|0.58||||0.005|2-Sided|95.0|0.4|0.85||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on male sterilization/vasectomy. Patients were excluded from this analysis if they reported not having heard of male sterilization/vasectomy in the post-visit survey.|
1632014|NCT02078713|2998360|Superiority||Odds Ratio (OR)|0.59||||0.002|2-Sided|95.0|0.42|0.82||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on female sterilization/tubal ligation. Patients were excluded from this analysis if they reported not having heard of female sterilization/tubal ligation in the post-visit survey.|
1632015|NCT02078713|2998360|Superiority||Odds Ratio (OR)|0.81||||0.07|2-Sided|95.0|0.64|1.02||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the ring. Patients were excluded from this analysis if they reported not having heard of the ring in the post-visit survey.|
1632016|NCT02078713|2998360|Superiority||Odds Ratio (OR)|0.97||||0.84|2-Sided|95.0|0.76|1.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the pull-out method. Patients were excluded from this analysis if they reported not having heard of the pull-out method in the post-visit survey.|
1632017|NCT02078713|2998360|Superiority||Odds Ratio (OR)|0.92||||0.55|2-Sided|95.0|0.69|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the patch. Patients were excluded from this analysis if they reported not having heard of the patch in the post-visit survey.|
1632018|NCT02078713|2998360|Superiority||Odds Ratio (OR)|0.85||||0.23|2-Sided|95.0|0.64|1.11||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the pill. Patients were excluded from this analysis if they reported not having heard of the pill in the post-visit survey.|
1632019|NCT02078713|2998360|Superiority||Odds Ratio (OR)|0.86||||0.26|2-Sided|95.0|0.65|1.12||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on the shot (Depo Provera). Patients were excluded from this analysis if they reported not having heard of the the shot (Depo Provera) in the post-visit survey.|
1632020|NCT02078713|2998360|Superiority||Odds Ratio (OR)|0.71||||0.009|2-Sided|95.0|0.54|0.92||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on condoms. Patients were excluded from this analysis if they reported not having heard of condoms in the post-visit survey.|
1632021|NCT02078713|2998360|Superiority||Odds Ratio (OR)|0.85||||0.17|2-Sided|95.0|0.67|1.07||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating of implant|
1632022|NCT02078713|2998360|Superiority||Odds Ratio (OR)|0.99||||0.92|2-Sided|95.0|0.75|1.3||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating on non-hormonal IUD. Patients were excluded from this analysis if they reported not having heard of the non-hormonal IUD in the post-visit survey.|
1632023|NCT02078713|2998360|Superiority||Odds Ratio (OR)|1.22||||0.13|2-Sided|95.0|0.92|1.6||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of rating for hormonal IUD. Patients excluded from analysis if they had not heard of hormonal IUD.|
1632024|NCT02078713|2998361|Superiority||Odds Ratio (OR)|0.91||||0.55|2-Sided|95.0|0.66|1.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.||
1632025|NCT02078713|2998362|Superiority||Odds Ratio (OR)|0.83||||0.23|2-Sided|95.0|0.6|1.13||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving a top score on the 5-point Likert scale at 7 months post-enrollment.|
1632026|NCT02078713|2998362|Superiority||Odds Ratio (OR)|0.9||||0.5|2-Sided|95.0|0.66|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention groups in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving top score at 4 months post-enrollment|
1632027|NCT02078713|2998362|Superiority||Odds Ratio (OR)|1.19||||0.25|2-Sided|95.0|0.88|1.61||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of percentage of patients giving top score at baseline|
1632028|NCT02078713|2998363|Superiority||Odds Ratio (OR)|2.47|||<|0.0001|2-Sided|95.0|1.75|3.49||P-value calculated in multiply imputed dataset.|Regression, Logistic||OR calculated in multiply imputed dataset. Intervention patients had 2.47 times the odds of control patients to give correct answer.|Comparison of correct knowledge - composite IUD knowledge item (all correct responses on items related to IUD knowledge, versus any incorrect)|
1632029|NCT02078713|2998363|Superiority||Odds Ratio (OR)|1.54|||<|0.005|2-Sided|95.0|1.14|2.07||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Implant does not affect fertility|
1632030|NCT02078713|2998363|Superiority||Odds Ratio (OR)|1.56|||<|0.004|2-Sided|95.0|1.15|2.1||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Non-hormonal IUD does not affect fertility|
1632031|NCT02078713|2998363|Superiority||Odds Ratio (OR)|1.61|||<|0.002|2-Sided|95.0|1.19|2.17||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Hormonal IUD does not affect fertility|
1632032|NCT02078713|2998363|Superiority||Odds Ratio (OR)|0.94|||<|0.77|2-Sided|95.0|0.62|1.43||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Depo does affect fertility|
1632033|NCT02078713|2998363|Superiority||Odds Ratio (OR)|1.7|||<|0.002|2-Sided|95.0|1.23|2.35||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - ring does not affect fertility|
1632034|NCT02078713|2998363|Superiority||Odds Ratio (OR)|1.65|||<|0.002|2-Sided|95.0|1.2|2.26||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.||Comparison of correct knowledge - patch does not affect fertility|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.
1632035|NCT02078713|2998363|Superiority||Odds Ratio (OR)|1.33|||<|0.08|2-Sided|95.0|0.96|1.84||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - pill does not affect fertility|
1632036|NCT02078713|2998363|Superiority||Odds Ratio (OR)|0.73|||<|0.31|2-Sided|95.0|0.39|1.34||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - EC can prevent pregnancy after sex|
1632037|NCT02078713|2998363|Superiority||Odds Ratio (OR)|0.77|||<|0.49|2-Sided|95.0|0.36|1.63||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - After sex, there is something you can do to prevent pregnancy|
1632071|NCT02077374|2998393|Superiority or Other||Median Difference (Net)|-0.8||||0.8724|2-Sided|95.0|-14.5|11.2|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change in aspartate aminotransferase (AST) from baseline to Day 28/ET between IDN-6556 and placebo|
1632038|NCT02078713|2998363|Superiority||Odds Ratio (OR)|2.76|||<|0.0001|2-Sided|95.0|1.72|4.41||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of knowledge - Copper IUD can act as EC|
1632039|NCT02078713|2998363|Superiority||Odds Ratio (OR)|1.15|||<|0.36|2-Sided|95.0|0.85|1.57||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - LARC can be removed early|
1632040|NCT02078713|2998363|Superiority||Odds Ratio (OR)|1.86|||<|0.001|2-Sided|95.0|1.28|2.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - Methods causing periods to stop are safe.|
1632041|NCT02078713|2998363|Superiority||Odds Ratio (OR)|1.92|||<|0.0002|2-Sided|95.0|1.36|2.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - IUDs are an option for nulliparous young women|
1632042|NCT02078713|2998363|Superiority||Odds Ratio (OR)|1.77|||<|0.0004|2-Sided|95.0|1.29|2.44||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - depo is more effective than condoms|
1632043|NCT02078713|2998363|Superiority||Odds Ratio (OR)|2.65|||<|0.0001|2-Sided|95.0|1.94|3.62||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - IUDs are more effective than pills|
1632044|NCT02078713|2998363|Superiority||Odds Ratio (OR)|1.27|||<|0.12|2-Sided|95.0|0.94|1.72||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of correct knowledge - pills are more effective than condoms|
1632045|NCT02078713|2998364|Superiority||Odds Ratio (OR)|1.06||||0.73|2-Sided|95.0|0.76|1.49||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of support subscale|
1632046|NCT02078713|2998364|Superiority||Odds Ratio (OR)|1.17||||0.31|2-Sided|95.0|0.86|1.59||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of values clarity subscale|
1632047|NCT02078713|2998364|Superiority||Odds Ratio (OR)|1.13||||0.5|2-Sided|95.0|0.8|1.59||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of effective decision subscale|
1632048|NCT02078713|2998364|Superiority||Odds Ratio (OR)|1.45||||0.03|2-Sided|95.0|1.03|2.05||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of uncertainty subscale of DCS|
1632049|NCT02078713|2998364|Superiority||Odds Ratio (OR)|1.34||||0.0496|2-Sided|95.0|1.0|1.8|||Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of informed decision subscale|
1632050|NCT02078713|2998364|Superiority||Odds Ratio (OR)|1.18||||0.41|2-Sided|95.0|0.8|1.74||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison of overall score|
1632051|NCT02078713|2998365|Superiority||Odds Ratio (OR)|1.27||||0.12|2-Sided|95.0|0.94|1.71||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.||
1632052|NCT02078713|2998366|Superiority||Relative risk ratio|2.14||||0.09|2-Sided|95.0|0.89|5.15||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of provider decision to both (ref)|
1632053|NCT02078713|2998366|Superiority||Relative risk ratio|1.13||||0.5|2-Sided|95.0|0.79|1.61||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patient decision to both (ref)|
1632054|NCT02078713|2998367|Superiority|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|Odds Ratio (OR)|1.3||||0.13|2-Sided|95.0|0.93|1.82||P-value calculated in multiply imputed dataset.|Regression, Logistic||The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.||
1632055|NCT02078713|2998368|Superiority||Relative risk ratio|0.69||||0.16|2-Sided|95.0|0.41|1.16||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who reported they wished provider had expressed preference more strongly, compared to right amount (ref).|
1632056|NCT02078713|2998368|Superiority||Relative risk ratio|1.0||||0.997|2-Sided|95.0|0.45|2.25||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who wished provider had expressed preference less strongly to right amount (ref).|
1632057|NCT02078713|2998369|Superiority||Relative risk ratio|1.6||||0.24|2-Sided|95.0|0.73|3.5||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who reported they wished their providers had been more involved, compared to right amount (ref)|
1632058|NCT02078713|2998369|Superiority||Relative risk ratio|1.1||||0.85|2-Sided|95.0|0.4|3.04||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group.|Comparison of patients who wished provider had been less involved to right amount (ref)|
1632059|NCT02078713|2998370|Superiority||Odds Ratio (OR)|1.11||||0.62|2-Sided|95.0|0.74|1.67||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.||
1632060|NCT02078713|2998371|Superiority||Odds Ratio (OR)|1.61||||0.01|2-Sided|95.0|1.11|2.33||P-value calculated in imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.||
1632061|NCT02078713|2998372|Superiority||Odds Ratio (OR)|1.45||||0.03|2-Sided|95.0|1.03|2.05||P-value calculated in multiply imputed dataset|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.||
1632062|NCT02078713|2998373|Superiority||Odds Ratio (OR)|0.79||||0.16|2-Sided|95.0|0.57|1.1||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 4 months post-enrollment|
1632063|NCT02078713|2998373|Superiority||Odds Ratio (OR)|0.89||||0.46|2-Sided|95.0|0.65|1.22||P-value calculated in multiply imputed dataset.|Regression, Logistic|We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen.|The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator.|Comparison at 7 months post-enrollment|
1632064|NCT02078492|2998377|Non-Inferiority or Equivalence|We assumed a minimal clinically significant difference (MCSD) of 1.3 between the three ketorolac groups at the 30-minute pain assessment and a standard deviation of 3.0. A power analysis determined that a sample of 78 subjects per group provided at least 80% power to detect an MCSD of at least 1.3 at 30 minutes with α=0.05.||||||0.783|||||||ANOVA|2 degrees of freedom||The main hypothesis was that there would be equivalence of dose effect across the three groups at every time point, and the primary comparison consisted of the pain assessment at 30 minutes.|
1632065|NCT02078219|2998384|Superiority or Other (legacy)||Mean Difference (Final Values)|-53.33|||<|0.0001|2-Sided|95.0|-61.0|-45.67|||ANCOVA, LOCF||||
1632066|NCT02078219|2998384|Superiority or Other (legacy)||Mean Difference (Final Values)|-49.25|||<|0.0001|2-Sided|95.0|-56.97|-41.52|||ANCOVA, LOCF||||
1632067|NCT02078219|2998384|Superiority or Other (legacy)||Mean Difference (Final Values)|-29.28|||<|0.0001|2-Sided|95.0|-36.99|-21.57|||ANCOVA, LOCF||||
1632068|NCT02077374|2998390|Superiority or Other||Median Difference (Net)|-327.0||||0.0471|2-Sided|95.0|-628.0|-7.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis of the difference in the change in full-length cytokeratine 18 (flCK18/M65) from Baseline to Day 28/ET between IDN-6556 and placebo|
1632069|NCT02077374|2998391|Superiority or Other||Median Difference (Net)|-250.0||||0.1365|2-Sided|95.0|-590.0|63.0|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in change for caspase 3/7 from Baseline to Day 28/ET between IDN-6556 and Placebo|
1632098|NCT02075840|2998519|Superiority||Difference in Overall Response Rates|7.4||||0.0936|2-Sided|95.0|-1.71|16.5||Stratified analysis|Mantel Haenszel||||
1632072|NCT02077374|2998395|Superiority or Other||Mean Difference (Net)|-17.0||||0.0195|2-Sided|95.0|-30.7|-2.5|||Wilcoxon (Mann-Whitney)||Based on Hodges-Lehmann estimator|Statistical Analysis for the difference in mean change in alanine aminotransferase (ALT) from Baseline to Day28/ET between IDN-6556 and placebo|
1632073|NCT02076412|2998435|Superiority||Risk Difference (RD)|-0.12||||0.2499|2-Sided|95.0|-0.32|0.09||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided||||
1632074|NCT02076412|2998436|Superiority||Risk Difference (RD)|-0.01||||0.4927|2-Sided|95.0|-0.05|0.02||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided||||
1632075|NCT02076412|2998441|Superiority||Risk Difference (RD)|13.8||||0.1519|2-Sided|95.0|0.5|27.1|||Fisher Exact||Confidence interval for treatment difference (risk difference) was based on the normal approximation||
1632076|NCT02076399|2998442|Superiority||Risk Difference (RD)|0.15||||0.3365|2-Sided|95.0|-0.2|0.5||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided||||
1632077|NCT02076399|2998443|Superiority||Risk Difference (RD)|-0.01||||0.6642|2-Sided|95.0|-0.01|0.0||P-value from a two-sided two-sample t-test, testing for a difference in means between fostamatinib and placebo.|t-test, 2 sided||||
1632078|NCT02076399|2998448|Superiority||Risk Difference (RD)|17.6||||0.0261|2-Sided|95.0|7.2|28.1|||Fisher Exact||||
1632079|NCT02076178|2998473|Superiority or Other||||||<|0.01|||||||Fisher Exact|||Any Grade 2 or higher event, any Grade 2 or higher event Vs Cabotegravir|
1632080|NCT02076165|2998474|Non-Inferiority|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). With respect to ISI, this represents a 2 point difference between the treatment effects.|Mean Difference (Net)|-0.57|Standard Error of the Mean|1.06|=|0|2-Sided|90.0|-2.32|1.17|||Mixed Models Analysis||The parameter estimate is the improvement in the ISI score from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.||
1632081|NCT02076165|2998475|Non-Inferiority|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). With respect to ISI, this represents a 2 point difference between the treatment effects.|Mean Difference (Net)|0.501|Standard Error of the Mean|0.9|=|0|2-Sided|90.0|-0.98|1.98|||Mixed Models Analysis||The parameter estimate is the improvement in the ISI score from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.||
1632082|NCT02076165|2998476|Non-Inferiority|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For actigraphically-estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|1.11|Standard Error of the Mean|1.37|<|0.001|2-Sided|90.0|-1.14|3.36|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.||
1632083|NCT02076165|2998477|Non-Inferiority|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For actigraphically-estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.68|Standard Error of the Mean|1.15|<|0.001|2-Sided|90.0|-1.21|2.57|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.||
1632084|NCT02076165|2998478|Non-Inferiority|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For sleep diary estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.757|Standard Error of the Mean|2.12||0.003|2-Sided|90.0|-2.72|4.23|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 3-month follow-up for ABCI group versus the same improvement in the CBTI group.||
1632085|NCT02076165|2998479|Non-Inferiority|We elected to use a value of δ equivalent to an effect size of d=0.40. (i.e., 4/10ths SD). For sleep diary estimated sleep efficiency, this represents a difference of 5%.|Mean Difference (Net)|0.409|Standard Error of the Mean|2.02|=|0|2-Sided|90.0|-2.92|3.74|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to post-treatment for ABCI group versus the same improvement in the CBTI group.||
1632086|NCT02076165|2998480|Superiority||Mean Difference (Final Values)|0.001|Standard Error of the Mean|0.048|=|0|2-Sided|95.0|-0.093|0.096|||Mixed Models Analysis||The proportion of nights participants who did not follow the recommendation to get out of bed if awake more than 20 minutes. Higher numbers indicate greater non-adherence.||
1632087|NCT02076165|2998481|Superiority||Mean Difference (Final Values)|-2.78|Standard Error of the Mean|5.17|=|0|2-Sided|95.0|-12.91|7.35|||Mixed Models Analysis||The average deviation, in minutes, between the recommended and actual rise time. Positive values indicate the number of minutes later than the recommended rise time that the participant got out of bed, indicating greater non-adherence.||
1632088|NCT02076165|2998482|Superiority||Mean Difference (Final Values)|-0.711|Standard Error of the Mean|3.59|=|0|2-Sided|95.0|-7.75|6.32|||Mixed Models Analysis||The average deviation, in minutes, between the recommended and actual bed time. Negative values indicate the number of minutes earlier than the recommended bed time that the participant went to bed, indicating greater non-adherence.||
1632089|NCT02076165|2998483|Superiority||||||=|0|||||||Fisher Exact|||Percentage of participants who completed all 5 treatment sessions, comparing ABC-I to CBT-I.|
1632090|NCT02075840|2998504|Superiority||Hazard Ratio (HR)|1.1||||0.6435|2-Sided|95.0|0.72|1.68||Stratified analysis|Log Rank|||Composite score|
1632091|NCT02075840|2998504|Superiority||Hazard Ratio (HR)|0.51||||0.0796|2-Sided|95.0|0.24|1.1||Stratified analysis|Log Rank|||Pain in chest|
1632092|NCT02075840|2998504|Superiority||Hazard Ratio (HR)|1.43||||0.2377|2-Sided|95.0|0.79|2.61||Stratified analysis|Log Rank|||Pain in arm and shoulder|
1632093|NCT02075840|2998504|Superiority||Hazard Ratio (HR)|1.76||||0.0285|2-Sided|95.0|1.05|2.92||Stratified analysis|Log Rank|||Dyspnea|
1632094|NCT02075840|2998504|Superiority||Hazard Ratio (HR)|0.88||||0.7042|2-Sided|95.0|0.44|1.74||Stratified analysis|Log Rank|||Coughing|
1632095|NCT02075840|2998506|Superiority||Hazard Ratio (HR)|1.66||||0.1137|2-Sided|95.0|0.88|3.15||Stratified analysis|Log Rank|||Dyspnea|
1632096|NCT02075840|2998506|Superiority||Hazard Ratio (HR)|0.74||||0.2079|2-Sided|95.0|0.46|1.19|||Log Rank|Stratified analysis||Fatigue|
1632097|NCT02075840|2998517|Superiority||Hazard Ratio (HR)|0.76||||0.2405|2-Sided|95.0|0.48|1.2||Stratified analysis|Log Rank||||
1632100|NCT02075840|2998523|Superiority||Hazard Ratio (HR)|0.5|||<|0.0001|2-Sided|95.0|0.36|0.7|||Log Rank|Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.|||
1632101|NCT02075840|2998525|Superiority||Hazard Ratio, stratified|0.47|||<|0.0001|2-Sided|95.0|0.34|0.65|||Log Rank|||Stratified hazard ratio and p-value are stratified for covariates Race (Asian vs Non-Asian) and CNS metastases at baseline by IRC.|
1632102|NCT02075606|2998537|Other||Odds Ratio (OR)|0.17|||=|0|2-Sided|95.0|0.02|1.65|||Regression, Logistic|||Clinical symptomatic response as dependent variable and CTC presence at baseline as explanatory variable was used to perform the logistic regression analysis.|
1632103|NCT02075515|2998568|Non-Inferiority or Equivalence|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within [0.67, 1.5].|Adjusted GMC ratio|0.99|||||2-Sided|95.0|0.88|1.1|||||||
1632104|NCT02075515|2998568|Non-Inferiority or Equivalence|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within [0.67, 1.5]|Adjustd GMC Ratio|0.96|||||2-Sided|95.0|0.85|1.08|||||||
1632105|NCT02075515|2998568|Non-Inferiority or Equivalence|Superiority Criterion: The two-sided 95 % CI of the GMC ratio between all pairs of lots are within [0.67, 1.5]|Adjusted GMC Ratio|0.97|||||2-Sided|95.0|0.86|1.09|||||||
1632106|NCT02075476|2998569|Equivalence|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.011|||||||Mixed Models Analysis||||
1632107|NCT02075476|2998570|Equivalence|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.001|||||||Mixed Models Analysis||||
1632108|NCT02075476|2998571|Equivalence|Normality in sample distribution was tested using the Kolmororov-Smirnov test and graphic models. For descriptive variables we use Pearson's Chi-square, and for the study of numerical variables over time we use a mixed linear test.||||||0.048|||||||Mixed Models Analysis||||
1632109|NCT02075255|2998606|Superiority or Other||Mean Difference (Final Values)|-159.4|||<|0.001|2-Sided|95.0|-217.9|-100.9|||Mixed Models Analysis|Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit.|Percent change||
1632110|NCT02075255|2998606|Superiority or Other||Mean Difference (Final Values)|-162.2|||<|0.001|2-Sided|95.0|-220.1|-104.3|||Mixed Models Analysis|Include covariates: treatment group, baseline eosinophil count, region, visit, treatment by visit|Percent change||
1632111|NCT02075255|2998610|Superiority or Other||Odds Ratio (OR)|1.783||||0.108|2-Sided|95.0|0.882|3.605|||Regression, Logistic|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.|||
1632112|NCT02075255|2998610|Superiority or Other||Odds Ratio (OR)|1.538||||0.22|2-Sided|95.0|0.773|3.06|||Regression, Logistic|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, number of exacerbations in the previous year.|||
1632113|NCT02075255|2998611|Superiority or Other||Mean Difference (Final Values)|0.45||||0.004|2-Sided|95.0|0.14|0.76|||Mixed Models Analysis|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.|||
1632114|NCT02075255|2998611|Superiority or Other||Mean Difference (Final Values)|0.23||||0.151|2-Sided|95.0|-0.08|0.53|||Mixed Models Analysis|Including covariates: treatment group, region, baseline AQLQ(S)+12 score, visit, and treatment by visit interaction.|||
1632115|NCT02075255|2998612|Superiority or Other||Odds Ratio (OR)|1.661||||0.155|2-Sided|95.0|0.826|3.34|||Regression, Logistic|Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.|||
1632116|NCT02075255|2998612|Superiority or Other||Odds Ratio (OR)|1.165||||0.658|2-Sided|95.0|0.592|2.295|||Regression, Logistic|Including covariates: treatment group, baseline ACQ-6 score, region, number of exacerbations in the previous year.|||
1632117|NCT02075255|2998613|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.001|2-Sided|95.0|-0.86|-0.23|||Mixed Models Analysis|Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.|||
1632118|NCT02075255|2998613|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.139|2-Sided|95.0|-0.55|0.08|||Mixed Models Analysis|Include covariates: treatment group, baseline ACQ-6 score, region, visit, and treatment by visit interaction.|||
1632119|NCT02075255|2998614|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.693|2-Sided|95.0|-0.11|0.07|||Mixed Models Analysis|Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.|||
1632120|NCT02075255|2998614|Superiority or Other||Mean Difference (Final Values)|0.02||||0.742|2-Sided|95.0|-0.08|0.11|||Mixed Models Analysis|Including covariates: treatment group, baseline proportion of nights with noctural awakenings, region, visit, and treatment by visit interaction.|||
1632121|NCT02075255|2998615|Superiority or Other||Mean Difference (Final Values)|31.52||||0.014|2-Sided|95.0|6.32|56.71|||Mixed Models Analysis|Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.|||
1632122|NCT02075255|2998615|Superiority or Other||Mean Difference (Final Values)|15.19||||0.237|2-Sided|95.0|-10.08|40.46|||Mixed Models Analysis|Include covariates: treatment group, baseline evening PEF, region, visit, and treatment by visit interaction.|||
1632123|NCT02075255|2998616|Superiority or Other||Mean Difference (Final Values)|30.01||||0.023|2-Sided|95.0|4.26|55.76|||Mixed Models Analysis|Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.|||
1632124|NCT02075255|2998616|Superiority or Other||Mean Difference (Final Values)|19.25||||0.143|2-Sided|95.0|-6.58|45.07|||Mixed Models Analysis|Include covariates: treatment group, baseline morning PEF, region, visit, and treatment by visit interaction.|||
1632125|NCT02075255|2998617|Superiority or Other||Mean Difference (Final Values)|-1.41||||0.006|2-Sided|95.0|-2.42|-0.41|||Mixed Models Analysis|Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.|||
1632126|NCT02075255|2998617|Superiority or Other||Mean Difference (Final Values)|-0.43||||0.397|2-Sided|95.0|-1.44|0.57|||Mixed Models Analysis|Include covariates: treatment group, baseline total asthma rescue medication use, region, visit, and treatment by visit interaction.|||
1632127|NCT02075255|2998618|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.48|2-Sided|95.0|-0.23|0.11|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.|||
1632128|NCT02075255|2998618|Superiority or Other||Mean Difference (Final Values)|0.0||||0.973|2-Sided|95.0|-0.17|0.17|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.|||
1632129|NCT02075255|2998619|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.177|2-Sided|95.0|-0.3|0.05|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.|||
1632130|NCT02075255|2998619|Superiority or Other||Mean Difference (Final Values)|0.0||||0.998|2-Sided|95.0|-0.18|0.18|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.|||
1632131|NCT02075255|2998620|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.291|2-Sided|95.0|-0.51|0.16|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.|||
1632132|NCT02075255|2998620|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.947|2-Sided|95.0|-0.35|0.32|||Mixed Models Analysis|Include covariates: treatment group, baseline asthma symptom score, region, visit, and treatment by visit interaction.|||
1632133|NCT02075255|2998621|Superiority or Other||Mean Difference (Final Values)|0.112||||0.129|2-Sided|95.0|-0.033|0.258|||Mixed Models Analysis|Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.|||
1632134|NCT02075255|2998621|Superiority or Other||Mean Difference (Final Values)|0.105||||0.153|2-Sided|95.0|-0.04|0.251|||Mixed Models Analysis|Including covariates: treatment group, region, baseline pre-BD FEV1 value, visit, and visit by treatment interaction.|||
1632135|NCT02075255|2998623|Superiority or Other||Rate ratio|0.07||||0.018|2-Sided|95.0|0.01|0.63|||negative binomial model|Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.|||
1632136|NCT02075255|2998623|Superiority or Other||Rate ratio|0.44||||0.187|2-Sided|95.0|0.13|1.49|||negative binomial model|Covariates include treatment, region, any exacerbations in the previous year requiring hospitalization/ER. Log of follow-up time is the offset.|||
1632137|NCT02075255|2998624|Superiority or Other||Rate ratio|0.3|||<|0.001|2-Sided|95.0|0.17|0.53|||negative binomial model|Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.|||
1632138|NCT02075255|2998624|Superiority or Other||Rate ratio|0.45|||<|0.003|2-Sided|95.0|0.27|0.76|||negative binomial model|Including covariates treatment group, region, number of exacerbations in the previous year. The log of follow-up time is used as offset variable.|||
1632139|NCT02075255|2998625|Superiority or Other||Hazard Ratio (HR)|0.12||||0.042|2-Sided|95.0|0.01|0.63|||Regression, Cox|Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.|||
1632140|NCT02075255|2998625|Superiority or Other||Hazard Ratio (HR)|0.53||||0.291|2-Sided|95.0|0.14|1.64|||Regression, Cox|Including covariates treatment group, region, any exacerbations in the previous year requiring hospitalization or ER visit.|||
1632141|NCT02075255|2998626|Superiority or Other||Hazard Ratio (HR)|0.32|||<|0.001|2-Sided|95.0|0.17|0.57|||Regression, Cox|Including covariates treatment group, region, number of exacerbations in the previous year.|||
1632142|NCT02075255|2998626|Superiority or Other||Hazard Ratio (HR)|0.39|||<|0.001|2-Sided|95.0|0.22|0.66|||Regression, Cox|Including covariates treatment group, region, number of exacerbations in the previous year.|||
1632143|NCT02075255|2998627|Superiority or Other||Odds Ratio (OR)|0.28|||<|0.001|2-Sided|95.0|0.14|0.56|||Cochran-Mantel-Haenszel|Controlling for region.|||
1632144|NCT02075255|2998627|Superiority or Other||Odds Ratio (OR)|0.32|||<|0.001|2-Sided|95.0|0.16|0.65|||Cochran-Mantel-Haenszel|Controlling for region.|||
1632145|NCT02075255|2998628|Superiority or Other||Odds Ratio (OR)|2.74||||0.002|2-Sided|95.0|1.41|5.31|||Cochran-Mantel-Haenszel|Controlling for region.|||
1632146|NCT02075255|2998628|Superiority or Other||Odds Ratio (OR)|3.16|||<|0.001|2-Sided|95.0|1.6|6.23|||Cochran-Mantel-Haenszel|Controlling for region.|||
1632147|NCT02075255|2998629|Superiority or Other||Odds Ratio (OR)|0.52||||0.053|2-Sided|95.0|0.27|1.01|||Cochran-Mantel-Haenszel|Controlling for region.|||
1632148|NCT02075255|2998629|Superiority or Other||Odds Ratio (OR)|0.42||||0.012|2-Sided|95.0|0.21|0.83|||Cochran-Mantel-Haenszel|Controlling for region.|||
1632149|NCT02075255|2998630|Superiority or Other||Odds Ratio (OR)|4.19||||0.002|2-Sided|95.0|1.58|11.12|||Cochran-Mantel-Haenszel|Controlling for region.|||
1632150|NCT02075255|2998630|Superiority or Other||Odds Ratio (OR)|5.23|||<|0.001|2-Sided|95.0|1.92|14.21|||Cochran-Mantel-Haenszel|Controlling for region.|||
1632151|NCT02075255|2998631|Superiority or Other||Odds Ratio (OR)|3.03|||<|0.001|2-Sided|95.0|1.57|5.86|||Cochran-Mantel-Haenszel|Controlling for region.|||
1632152|NCT02075255|2998631|Superiority or Other||Odds Ratio (OR)|3.59|||<|0.001|2-Sided|95.0|1.79|7.22|||Cochran-Mantel-Haenszel|Controlling for region.|||
1632153|NCT02075255|2998632|Superiority or Other||Median Difference (Final Values)|50.0|||<|0.001|2-Sided|95.0|25.0|66.7|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.||
1632154|NCT02075255|2998632|Superiority or Other||Median Difference (Final Values)|50.0|||<|0.001|2-Sided|95.0|25.0|66.7|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.||
1632155|NCT02075255|2998633|Superiority or Other||Odds Ratio (OR)|4.12|||<|0.001|2-Sided|95.0|2.22|7.63|||proportional odds model|Controlling for treatment group, region, and baseline OCS dose.|||
1632156|NCT02075255|2998633|Superiority or Other||Odds Ratio (OR)|4.09|||<|0.001|2-Sided|95.0|2.22|7.57|||proportional odds model|Controlling for treatment group, region, and baseline OCS dose.|||
1632157|NCT02075255|2998634|Superiority or Other||Median Difference (Final Values)|37.5|||<|0.001|2-Sided|95.0|20.8|50.0|||Wilcoxon (Mann-Whitney)||Hodges Lehmann estimate is used.||
1632158|NCT02075255|2998634|Superiority or Other||Median Difference (Final Values)|33.3|||<|0.001|2-Sided|95.0|16.7|50.0|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate is used.||
1632858|NCT02057757|3000269|Superiority|||||||0.8628||||||Difficulty Breathing|Fay-Shaw||||
1632160|NCT02074553|2998683|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.43|||||2-Sided|90.0|72.7|78.27|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632161|NCT02074553|2998683|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|76.79|||||2-Sided|90.0|74.03|79.65|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632162|NCT02074553|2998683|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.28|||||2-Sided|90.0|85.06|91.63|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632163|NCT02074553|2998683|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.86|||||2-Sided|90.0|62.71|73.43|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632164|NCT02074553|2998683|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|87.16|||||2-Sided|90.0|80.59|94.26|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632165|NCT02074553|2998683|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|97.23|||||2-Sided|90.0|89.85|105.21|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632166|NCT02074553|2998684|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.26|||||2-Sided|90.0|69.53|77.19|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632167|NCT02074553|2998684|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.82|||||2-Sided|90.0|71.99|79.86|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632168|NCT02074553|2998684|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.76|||||2-Sided|90.0|84.21|93.56|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632169|NCT02074553|2998684|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|42.32|||||2-Sided|90.0|38.68|46.32|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632170|NCT02074553|2998684|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|66.84|||||2-Sided|90.0|61.12|73.1|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632171|NCT02074553|2998684|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|89.41|||||2-Sided|90.0|81.7|97.84|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632172|NCT02074553|2998685|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|76.65|||||2-Sided|90.0|73.92|79.49|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632276|NCT02072174|2998873|Superiority|||||||0.0084|||||||Kruskal-Wallis|||Days 1-7 (patient diary data)|
1632173|NCT02074553|2998685|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|77.74|||||2-Sided|90.0|74.99|80.6|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632174|NCT02074553|2998685|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.81|||||2-Sided|90.0|85.62|92.13|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632175|NCT02074553|2998685|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.41|||||2-Sided|90.0|67.81|79.47|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632176|NCT02074553|2998685|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|91.58|||||2-Sided|90.0|84.65|99.08|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632177|NCT02074553|2998685|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|98.79|||||2-Sided|90.0|91.25|106.95|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632178|NCT02074553|2998688|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|69.34|||||2-Sided|90.0|66.23|72.61|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632179|NCT02074553|2998688|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|72.72|||||2-Sided|90.0|69.48|76.12|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632180|NCT02074553|2998688|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.21|||||2-Sided|90.0|86.12|94.49|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632181|NCT02074553|2998688|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|43.94|||||2-Sided|90.0|39.78|48.53|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632182|NCT02074553|2998688|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|74.35|||||2-Sided|90.0|67.37|82.06|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632183|NCT02074553|2998688|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|93.05|||||2-Sided|90.0|84.24|102.78|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632184|NCT02074553|2998689|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|70.94|||||2-Sided|90.0|67.8|74.22|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632185|NCT02074553|2998689|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.76|||||2-Sided|90.0|70.52|77.15|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632277|NCT02072174|2998874|Superiority|||||||0.0994||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 5 (doctor's examination)|
1632186|NCT02074553|2998689|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.16|||||2-Sided|90.0|86.14|94.37|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632187|NCT02074553|2998689|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|53.91|||||2-Sided|90.0|49.27|58.98|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632188|NCT02074553|2998689|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.69|||||2-Sided|90.0|71.97|86.04|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632189|NCT02074553|2998689|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|95.77|||||2-Sided|90.0|87.54|104.79|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632190|NCT02074553|2998691|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.76|||||2-Sided|90.0|63.48|72.33|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632191|NCT02074553|2998691|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|73.26|||||2-Sided|90.0|68.67|78.16|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632192|NCT02074553|2998691|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|95.15|||||2-Sided|90.0|89.1|101.62|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632193|NCT02074553|2998691|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|34.32|||||2-Sided|90.0|30.83|38.21|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632194|NCT02074553|2998691|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|67.24|||||2-Sided|90.0|60.44|74.79|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632195|NCT02074553|2998691|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|91.67|||||2-Sided|90.0|82.34|102.05|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632196|NCT02074553|2998693|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|75.65|||||2-Sided|90.0|71.71|79.82|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632197|NCT02074553|2998693|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|77.0|||||2-Sided|90.0|73.01|81.2|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632198|NCT02074553|2998693|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|86.3|||||2-Sided|90.0|81.77|91.09|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632278|NCT02072174|2998874|Superiority|||||||0.0056||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 3 (doctor's examination)|
1632199|NCT02074553|2998693|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|41.04|||||2-Sided|90.0|37.4|45.03|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632200|NCT02074553|2998693|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|66.28|||||2-Sided|90.0|60.45|72.68|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632201|NCT02074553|2998693|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|90.34|||||2-Sided|90.0|82.33|99.12|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632202|NCT02074553|2998694|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.66|||||2-Sided|90.0|75.53|81.92|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632203|NCT02074553|2998694|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|78.87|||||2-Sided|90.0|75.76|82.11|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632204|NCT02074553|2998694|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|87.42|||||2-Sided|90.0|83.92|91.07|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632205|NCT02074553|2998694|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|80.32|||||2-Sided|90.0|74.41|86.7|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632206|NCT02074553|2998694|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|93.79|||||2-Sided|90.0|86.94|101.17|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632207|NCT02074553|2998694|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|99.12|||||2-Sided|90.0|91.83|106.99|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632208|NCT02074553|2998695|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|79.95|||||2-Sided|90.0|76.84|83.19|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632209|NCT02074553|2998695|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|80.17|||||2-Sided|90.0|77.08|83.39|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632210|NCT02074553|2998695|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|88.62|||||2-Sided|90.0|85.15|92.24|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632211|NCT02074553|2998695|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|86.66|||||2-Sided|90.0|80.32|93.5|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632279|NCT02072174|2998874|Superiority|||||||0.0603||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 5 (patient diary data)|
1632212|NCT02074553|2998695|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|97.82|||||2-Sided|90.0|90.71|105.48|||||The reported values are percentages of geometric least square mean ratio.|ANOVA (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% CI.|
1632213|NCT02074553|2998695|Non-Inferiority or Equivalence|Bioequivalence of the test formulation was concluded if its 90% CI was included in the bioequivalence range of 80% to 125%.|Geometric Least Square Mean Ratio|100.5|||||2-Sided|90.0|93.14|108.44|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) (fixed factors: treatment, period, and treatment sequence; and random factor: participant) was applied to the log-transformed PK parameter, and then back transformed to provide geometric least square mean ratio (Test/Reference) and 90% confidence interval (CI).|
1632214|NCT02074358|2998710|Superiority or Other||mixed effect model|1.018|||||2-Sided|90.0|0.94|1.102|||||Treatment C versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment C versus Treatment A). No adjustment was made for multiplicity.|
1632215|NCT02074358|2998710|Superiority or Other||mixed effect model|1.019|||||2-Sided|90.0|0.955|1.087|||||Treatment B versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment B versus Treatment A). No adjustment was made for multiplicity.|
1632216|NCT02074358|2998712|Superiority or Other||mixed effect model|1.021|||||2-Sided|90.0|0.938|1.112|||||Treatment C versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment C versus Treatment A). No adjustment was made for multiplicity.|
1632217|NCT02074358|2998712|Superiority or Other||mixed effect model|1.039|||||2-Sided|90.0|0.972|1.111|||||Treatment B versus Treatment A|Analysis used a linear mixed effect model including treatment, period, and sequence as fixed effects and within-participant measurements as repeated measures. Point estimates and 90% confidence intervals (CIs) for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale between each PCC treatment and placebo (ie, Treatment B versus Treatment A, and Treatment C versus Treatment A). No adjustment was made for multiplicity.|
1632218|NCT02074358|2998722|Superiority or Other||mixed effect models|-0.17||||0.114|2-Sided|95.0|-0.389|0.048||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Anti-Xa Activity. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632219|NCT02074358|2998722|Superiority or Other||mixed effect models|-0.239||||0.204|2-Sided|95.0|-0.625|0.146||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|Anti-Xa Activity. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632220|NCT02074358|2998723|Superiority or Other||mixed effect model|-0.176|||<|0.001|2-Sided|95.0|-0.242|-0.11||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|INR (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632221|NCT02074358|2998723|Superiority or Other||mixed effect model|-0.239|||<|0.001|2-Sided|95.0|-0.305|-0.173||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|INR (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632260|NCT02072668|2998847|Superiority|||||||0.4442|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect|||
1632261|NCT02072668|2998848|Superiority|||||||0.7973|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect|||
1632280|NCT02072174|2998874|Superiority|||||||0.0484||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 4 (patient diary data)|
1632222|NCT02074358|2998723|Superiority or Other||mixed effect model|-0.17|||<|0.001|2-Sided|95.0|-0.229|-0.111||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|INR (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632223|NCT02074358|2998723|Superiority or Other||mixed effect model|-0.198|||<|0.001|2-Sided|95.0|-0.266|-0.13||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|INR (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632224|NCT02074358|2998724|Superiority or Other||mixed effect model|2.3|||<|0.001|2-Sided|95.0|1.28|3.32||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|aPTT. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632225|NCT02074358|2998724|Superiority or Other||mixed effect model|8.47|||<|0.001|2-Sided|95.0|6.29|10.66||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|aPTT. The ETP change from pre-PCC baseline was analyzed using a mixed effect model and included treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632226|NCT02074358|2998724|Superiority or Other||mixed effect model|-1.89|||<|0.001|2-Sided|95.0|-2.59|-1.2||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|PT (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632227|NCT02074358|2998724|Superiority or Other||mixed effect model|-2.59|||<|0.001|2-Sided|95.0|-3.3|-1.89||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|PT (Recombiplastin 2G). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632228|NCT02074358|2998724|Superiority or Other||mixed effect model|-1.47|||<|0.001|2-Sided|95.0|-1.95|-0.99||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|PT (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632229|NCT02074358|2998724|Superiority or Other||mixed effect model|-1.64|||<|0.001|2-Sided|95.0|-2.16|-1.12||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|PT (Neoplastin CI+). ETP change from pre-PCC baseline was analyzed using mixed effect model that included treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632262|NCT02072668|2998849|Superiority|||||||0.6281|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect|||
1632263|NCT02072434|2998850|Other||Difference between percentages|-0.72|||||2-Sided|95.0|-1.59|0.15|||||||
1632264|NCT02072434|2998851|Other||Odds Ratio (OR)|1.48|||||2-Sided|95.0|0.64|3.55|||||||
1632265|NCT02072434|2998852|Other||Odds Ratio (OR)|0.46|||||2-Sided|95.0|0.12|1.43|||||||
1632562|NCT02063698|2999607|Superiority|||||||0.7|||||||Fisher Exact|||Day 6: BPI Worst Pain Past 24 Hours|
1632230|NCT02074358|2998725|Superiority or Other||mixed effect model|-6.5|||<|0.001|2-Sided|95.0|-9.5|-3.6||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632231|NCT02074358|2998725|Superiority or Other||mixed effect model|0.0|||<|0.996|2-Sided|95.0|-5.6|5.6||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632232|NCT02074358|2998726|Superiority or Other||mixed effect model|-6.4||||0.076|2-Sided|95.0|-13.5|0.8||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632233|NCT02074358|2998726|Superiority or Other||mixed effect model|21.1||||0.014|2-Sided|95.0|4.9|37.2||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632234|NCT02074358|2998727|Superiority or Other||mixed effect model|4.62|||<|0.001|2-Sided|95.0|2.8|6.44||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Time to Peak. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632235|NCT02074358|2998727|Superiority or Other||mixed effect model|1.35|||<|0.2|2-Sided|95.0|-0.81|3.52||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|Time to Peak. ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632236|NCT02074358|2998727|Superiority or Other||mixed effect model|-0.16|||<|0.142|2-Sided|95.0|-0.38|0.06||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for this secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|Lag Time. ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632237|NCT02074358|2998727|Superiority or Other||mixed effect model|-0.21|||<|0.389|2-Sided|95.0|-0.73|0.3||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for other secondary endpoints since a non-significant treatment difference was observed for this first secondary endpoint (TGA lag time).|Mixed Models Analysis||Treatment B versus Treatment A|TGA Lag Time. ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632266|NCT02072226|2998862|Other|Confidence Interval|difference in percentages|3.87|||||2-Sided|95.0|-1.23|9.49||||||Any ICH within 36 hours reported by central reader|
1632267|NCT02072226|2998862|Other|Confidence Interval|difference in percentages|4.53|||||2-Sided|95.0|-0.34|10.07||||||Any ICH within 36 hours reported by site|
1632268|NCT02072226|2998863|Other|Confidence Interval|difference in percentages|3.25|||||2-Sided|95.0|0.75|7.38|||||||
1632269|NCT02072226|2998864|Other|Confidence Interval|Odds Ratio (OR)|0.858|||||2-Sided|95.0|0.529|1.393|||||||
1632270|NCT02072226|2998865|Other|Confidence Interval|Odds Ratio (OR)|0.81|||||2-Sided|95.0|0.527|1.244|||||||
1632238|NCT02074358|2998728|Superiority or Other||mixed effect model|90.6||||0.131|2-Sided|95.0|-31.3|212.4||In the hierarchical analysis, no statistical inferences were drawn from the analysis results for any secondary endpoint since a non-significant treatment difference was observed for the primary endpoint.|Mixed Models Analysis||Treatment C versus Treatment A|ETP change from pre-PCC baseline was analyzed using mixed effect model, including treatment, sequence, and period as main effects. Hierarchical analysis was conducted with comparisons beginning with primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632239|NCT02074358|2998728|Superiority or Other||mixed effect model|425.3|||<|0.001|2-Sided|95.0|219.8|630.7|||Mixed Models Analysis||Treatment B versus Treatment A|The ETP change from pre-PCC baseline was analyzed using a mixed effect model that included treatment, sequence, and period as main effects. A hierarchical analysis was conducted with comparisons beginning with the primary endpoint and continuing through secondary endpoints (ETP; TGA lag time; TGA time to peak; TGA peak; TGA velocity index; PT; INR; aPTT; AXA). If resulting p-value was < 0.05, then the next comparison of interest was made until p>0.05 at which point, comparisons ended.|
1632240|NCT02073682|2998760|Superiority||Cox Proportional Hazard|1.08||||0.4199|2-Sided|95.0|0.898|1.293|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.|
1632241|NCT02073682|2998761|Superiority||Cox Proportional Hazard|1.56||||0.4873|2-Sided|95.0|0.444|5.505|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.|
1632242|NCT02073682|2998762|Superiority||Cox Proportional Hazard|0.9||||0.7324|2-Sided|95.0|0.502|1.624|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.|
1632243|NCT02073682|2998763|Superiority||Cox Proportional Hazard|0.56||||0.0394|2-Sided|95.0|0.318|0.972|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.|
1632244|NCT02073682|2998764|Superiority||Cox Proportional Hazard|0.71||||0.0931|2-Sided|95.0|0.476|1.059|||Cox proportional hazard|||The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.|
1632245|NCT02073682|2998765|Superiority||Hazard Ratio (HR)|2.0||||0.0254|2-Sided|95.0|1.089|3.657|||Regression, Cox|||The HR, 2-sided CI and p-value are based on the Cox regression model with counting process approach for on-treatment including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.|
1632246|NCT02073682|2998766|Superiority|The hazard ratio (HR), two-sided confidence interval (CI) and p-value are based on the Cox proportional hazard model including treatment and the two stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.||||||0.8712|||||||Cox proportional hazard||||
1632247|NCT02073682|2998766|Non-Inferiority|Edoxaban Group was considered non-inferior to the Dalteparin Group if the upper limit of the 2-sided 95% confidence interval (CI) for the Hazard Ratio ([LMW] Edoxaban Group to Dalteparin Group) was less than 1.5.|Cox Proportional Hazard|0.97||||0.0056|2-Sided|95.0|0.696|1.359|||Cox proportional hazard||||
1632248|NCT02072824|2998831|Superiority||Odds Ratio (OR)|1.622||||0.305|2-Sided|95.0|0.644|4.086|||Regression, Logistic|||The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.|
1632249|NCT02072824|2998831|Superiority||Odds Ratio (OR)|0.625||||0.2418|2-Sided|95.0|0.284|1.373|||Regression, Logistic|||The dichotomized responder variable was analyzed using a logistic regression model via maximum likelihood estimation with treatment group, age stratum, and geographical region as a fixed effect covariates.|
1632250|NCT02072824|2998832|Superiority||Least Square Mean Difference|-0.43|Standard Error of the Mean|0.185||0.0223|2-Sided|95.0|-0.8|-0.06|||ANCOVA|||Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.|
1632251|NCT02072824|2998832|Superiority||Least Square Mean Difference|0.11|Standard Error of the Mean|0.153||0.4606|2-Sided|95.0|-0.19|0.42|||ANCOVA|||Linear model with log transformed baseline seizure rate as continuous covariate and treatment, age stratum, and geographical region as fixed factor effects.|
1632252|NCT02072668|2998833|Superiority|||||||0.725|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect|||
1632253|NCT02072668|2998834|Superiority|||||||0.0767|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect|||
1632254|NCT02072668|2998835|Superiority|||||||0.4501|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect|||
1632255|NCT02072668|2998836|Superiority|||||||0.0708|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect|||
1632256|NCT02072668|2998838|Superiority|||||||0.0755|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect|||
1632257|NCT02072668|2998839|Superiority|||||||0.347|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect|||
1632258|NCT02072668|2998840|Superiority|||||||0.4374|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect|||
1632259|NCT02072668|2998846|Superiority|||||||0.2545|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect|||
1632281|NCT02072174|2998874|Superiority|||||||0.0041||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 3 (patient diary data)|
1632282|NCT02072174|2998874|Superiority|||||||0.0104||||||p-value not adjusted for multiple comparisons|Kruskal-Wallis|||Day 2 (patient diary data)|
1632283|NCT02072174|2998875|Superiority|||||||0.0043|||||||Cochran-Mantel-Haenszel||||
1632284|NCT02072174|2998876|Superiority|||||||0.322||||||"The p-value associated with treatment*visit interaction factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment*visit interaction, Day 1 covariate."|Mixed Models Analysis||||
1632285|NCT02072174|2998876|Superiority|||||||0.0394||||||"The p-value associated with treatment factor of variable on day 2, 3, 4 and 5 between Anaferon for Children and Placebo. Model includes treatment, visit, treatment*visit interaction, Day 1 covariate. Treatment*visit interaction p-value is 0.3220."|Mixed Models Analysis||||
1632286|NCT02072174|2998877|Superiority|||||||0.0127|||||||Cochran-Mantel-Haenszel|||doctor's examination data|
1632287|NCT02072174|2998877|Superiority|||||||0.0026|||||||Cochran-Mantel-Haenszel|||patient diary data|
1632288|NCT02072174|2998878|Superiority|||||||0.0242|||||||Kruskal-Wallis||||
1632289|NCT02071290|2998927|Superiority|||||||0.911|||||||Chi-squared||||
1632290|NCT02071290|2998928|Superiority|||||||0.348|||||||Chi-squared||||
1632291|NCT02071290|2998929|Superiority|||||||0.51|||||||Chi-squared||||
1632292|NCT02071290|2998930|Superiority|||||||0.151|||||||Wilcoxon (Mann-Whitney)||||
1632293|NCT02071290|2998931|Superiority|||||||0.287|||||||Wilcoxon (Mann-Whitney)||||
1632294|NCT02071290|2998932|Superiority|||||||0.323|||||||Wilcoxon (Mann-Whitney)||||
1632295|NCT02071290|2998933|Superiority|||||||0.829|||||||Mixed Models Analysis||||
1632296|NCT02071290|2998934|Superiority|||||||0.106|||||||Mixed Models Analysis||||
1632297|NCT02071290|2998935|Superiority|||||||0.371|||||||Mixed Models Analysis||||
1632298|NCT02071290|2998936|Superiority|||||||0.085|||||||Mixed Models Analysis||||
1632299|NCT02071290|2998937|Superiority|||||||0.99|||||||Mixed Models Analysis||||
1632300|NCT02071290|2998938|Superiority|||||||0.353|||||||Mixed Models Analysis||||
1632301|NCT02071290|2998939|Superiority|||||||0.437|||||||Mixed Models Analysis||||
1632302|NCT02071290|2998940|Superiority|||||||0.916|||||||Mixed Models Analysis||||
1632303|NCT02071290|2998941|Superiority|||||||0.661|||||||Mixed Models Analysis||||
1632304|NCT02071290|2998942|Superiority|||||||0.664|||||||Mixed Models Analysis||||
1632305|NCT02071290|2998943|Superiority|||||||0.637|||||||Mixed Models Analysis||||
1632306|NCT02071290|2998944|Superiority|||||||0.967|||||||Mixed Models Analysis||||
1632307|NCT02071290|2998945|Superiority|||||||0.075|||||||Mixed Models Analysis||||
1632308|NCT02071290|2998946|Superiority|||||||0.757|||||||Mixed Models Analysis||||
1632309|NCT02071290|2998947|Superiority|||||||0.646|||||||Mixed Models Analysis||||
1632310|NCT02071290|2998948|Superiority|||||||0.307|||||||Mixed Models Analysis||||
1632311|NCT02071290|2998949|Superiority|||||||0.597|||||||Mixed Models Analysis||||
1632312|NCT02071290|2998950|Superiority|||||||0.287|||||||Mixed Models Analysis||||
1632313|NCT02071290|2998951|Superiority|||||||0.56|||||||Mixed Models Analysis||||
1632314|NCT02070991|2999000|Superiority or Other||Treatment effect (mean change from BL)|-0.4|||||2-Sided|95.0|-4.5|3.6|||||||
1632315|NCT02070991|2999001|Superiority or Other||Treatment effect (mean change from BL)|0.4|||||2-Sided|95.0|0.11|0.69|||||||
1632316|NCT02070991|2999002|Superiority or Other||Treatment effect (mean change from BL)|-0.3|||||2-Sided|95.0|-4.2|3.7|||||||
1632317|NCT02070991|2999003|Superiority or Other||Treatment effect (mean change from BL)|0.7|||||2-Sided|95.0|-2.2|3.6|||||||
1632318|NCT02070991|2999004|Superiority or Other||Treatment effect (mean change from BL)|0.3|||||2-Sided|95.0|-4.3|4.9|||||||
1632319|NCT02070991|2999005|Superiority or Other||Treatment effect (ratio of geom. means)|0.93|||||2-Sided|95.0|0.64|1.36|||||||
1632320|NCT02070991|2999006|Superiority or Other||Treatment effect (ratio of geom. means)|0.77|||||2-Sided|95.0|0.55|1.08|||||||
1632321|NCT02070991|2999007|Superiority or Other||Difference between maci. and placebo|10.08||||0.3372|2-Sided|95.0|-15.07|33.26|||Fisher Exact||||
1632322|NCT02070757|2999030|Other|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (<65, >=65) categories.|Difference in Percentage of Participants|3.3|||||2-Sided|95.0|-3.38|10.44|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants|
1632323|NCT02070757|2999031|Other|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (<65, >=65) categories.|Difference in Percentage of Participants|1.6|||||2-Sided|95.0|-8.91|12.02|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants|
1632324|NCT02070757|2999032|Other|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (<65, >=65) categories.|Difference in Percentage of Participants|-0.8|||||2-Sided|95.0|-7.67|6.04|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants|
1632347|NCT02070380|2999078|Superiority or Other||||||<|1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus post-dose paired global assessment."|
1632456|NCT02066389|2999315|Superiority|||||||0.012||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632325|NCT02070757|2999033|Other|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (<65, >=65) categories.|Difference in Percentage of Participants|-1.4|||||2-Sided|95.0|-6.41|3.57|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants|
1632326|NCT02070757|2999035|Other|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (<65, >=65) categories.|Difference in Percentage of Participants|7.0||||||95.0|-5.11|18.93|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants|
1632327|NCT02070757|2999036|Other|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (<65, >=65) categories.|Difference in Percentage of Participants|-1.3|||||2-Sided|95.0|-10.21|7.67|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants|
1632328|NCT02070757|2999037|Other|The % difference is the weighted proportion difference using Mehrotra-Railkar continuity-corrected-minimum risk (MRc) stratum weights for strata of diagnosis (VABP, ventilated HABP) and age (<65, >=65) categories.|Difference in Percentage of Participants|4.4|||||2-Sided|95.0|-2.83|11.75|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in Percentage of Participants|
1632329|NCT02070757|2999038|Non-Inferiority|Clinical Response difference is calculated as ceftolozane/tazobactam minus meropenem. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -12.5%.|Difference in percentage of participants|1.1|||||2-Sided|95.0|-6.17|8.29|||||The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.||
1632330|NCT02070757|2999039|Non-Inferiority|Meropenem minus ceftolozane/tazobactam. For ceftolozane/tazobactam to be non-inferior to meropenem the lower bound of a 2-sided 95% confidence interval (CI) for the difference between treatment groups had to be ≥ -10%.|Difference in Percentage of Participants|1.1|||||2-Sided|95.0|-5.13|7.39|||||The % difference between groups is the weighted proportion difference using MRc stratum weights for diagnosis and age categories. The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference.||
1632331|NCT02070380|2999076|Superiority or Other|||||||0.0003|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.|||
1632332|NCT02070380|2999076|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.|||
1632333|NCT02070380|2999076|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.|||
1632334|NCT02070380|2999076|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.|||
1632335|NCT02070380|2999076|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.|||
1632336|NCT02070380|2999076|Superiority or Other||||||<|0.0002|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.|||
1632337|NCT02070380|2999077|Superiority or Other|||||||0.7726|||||||Mixed Models Analysis||||
1632338|NCT02070380|2999077|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1632339|NCT02070380|2999077|Superiority or Other||||||<|0.1156|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect|||
1632340|NCT02070380|2999077|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect.|||
1632341|NCT02070380|2999077|Superiority or Other||||||<|0.6898|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect|||
1632342|NCT02070380|2999077|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect|||
1632343|NCT02070380|2999078|Superiority or Other|||||||0.5983|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.05 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."|
1632344|NCT02070380|2999078|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."|
1632345|NCT02070380|2999078|Superiority or Other||||||<|0.7503|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."|
1632346|NCT02070380|2999078|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."|
1632348|NCT02070380|2999078|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Contrast Enhancement in an off-site pre-dose plus postdose paired global assessment."|
1632349|NCT02070380|2999079|Superiority or Other|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."|
1632350|NCT02070380|2999079|Superiority or Other|||||||0.0023|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."|
1632351|NCT02070380|2999079|Superiority or Other|||||||1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."|
1632352|NCT02070380|2999079|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."|
1632353|NCT02070380|2999079|Superiority or Other||||||<|1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus post-dose paired global assessment."|
1632354|NCT02070380|2999079|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Extent of Disease in an off-site pre-dose plus postdose paired global assessment."|
1632355|NCT02070380|2999080|Superiority or Other|||||||0.5811|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."|
1632356|NCT02070380|2999080|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."|
1632357|NCT02070380|2999080|Superiority or Other||||||<|1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."|
1632358|NCT02070380|2999080|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."|
1632359|NCT02070380|2999080|Superiority or Other||||||<|1|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus post-dose paired global assessment."|
1632360|NCT02070380|2999080|Superiority or Other||||||<|0.002|||||||Wilcoxon signed-rank test|||"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Internal Morphology in an off-site pre-dose plus postdose paired global assessment."|
1632361|NCT02070380|2999081|Superiority or Other|||||||0.8145||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."|
1632362|NCT02070380|2999081|Superiority or Other||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."|
1632363|NCT02070380|2999081|Superiority or Other||||||<|0.4597||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."|
1632364|NCT02070380|2999081|Superiority or Other||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."|
1632365|NCT02070380|2999081|Superiority or Other||||||<|0.8238||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus post-dose paired global assessment."|
1632366|NCT02070380|2999081|Superiority or Other||||||<|0.0001||||||The priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test|||"This is a secondary analysis.~Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of Lesion Border Delineation in an off-site pre-dose plus postdose paired global assessment."|
1632367|NCT02070380|2999082|Superiority or Other||∆Percentage MH better minus DM better|-2.1||||0.7297|2-Sided|95.0|-13.8|9.6||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman’s general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."|
1632385|NCT02068599|2999167|Superiority||LSM difference from placebo|0.01||||0.9208|2-Sided|95.0|-0.232|0.257||5% level of significance|mixed model for repeated measures|||Week 2|
1632368|NCT02070380|2999082|Superiority or Other||∆Percentage MH better minus DM better|66.1|||<|0.0001|2-Sided|95.0|52.8|79.5||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman’s general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment"|
1632369|NCT02070380|2999082|Superiority or Other||Percentage MH better minus DM better|-2.1|||<|0.7503|2-Sided|95.0|-15.0|10.7||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman’s general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."|
1632370|NCT02070380|2999082|Superiority or Other||∆Percentage MH better minus DM better|79.0|||<|0.0001|2-Sided|95.0|67.1|91.0||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed rank test||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman’s general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus postdose paired global assessment"|
1632371|NCT02070380|2999082|Superiority or Other||∆Percentage MH better minus DM better|7.3|||<|0.1295|2-Sided|95.0|-2.0|16.5||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test.||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman’s general approximate normal method.|"Null hypotheses:~A 0.05 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus post-dose paired global assessment."|
1632372|NCT02070380|2999082|Superiority or Other||∆Percentage MH better minus DM better|47.6|||<|0.0001|2-Sided|95.0|34.5|60.7||Only 1 primary endpoint, no adjustment for multiple comparisons and the a priori threshold for statistical significance was 0.05.|Wilcoxon signed-rank test.||Difference in percentage MultiHance better minus percentage Dotarem better (%) , 2-sided 95% confidence interval was estimated using Altman’s general approximate normal method.|"Null hypotheses:~A 0.1 mmol/kg dose of MULTIHANCE is equal to a 0.1 mmol/kg dose of DOTAREM, in terms of the assessment of global diagnostic preference in an off-site pre-dose plus postdose paired global assessment."|
1632373|NCT02069704|2999105|Equivalence|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%–125%.|ratio BEVZ92 to Avastin|100.0|||||2-Sided|90.0|90.2|112.0|||||||
1632374|NCT02069704|2999106|Equivalence|Two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80%–125%.|ratio BEVZ92 to Avastin|99.4|||||2-Sided|90.0|90.5|109.0|||||For the ratio: BEVZ92 represents the numerator and reference bevacizumab the denominator|Based on previously published PK data for reference bevacizumab in metastatic colorectal cancer, we assumed a conservative inter-participant coefficient of variation for AUC of around 35%. A sample size of 51 patients in each treatment arm could show bioequivalence with a nominal power of 90% and an α of 0·05, if the 90% CIs for the ratio of BEVZ92 to reference bevacizumab of the geometric means for AUC0–336h and AUCss were within the acceptance interval of 80%–125%.|
1632375|NCT02069093|2999146|Superiority or Other||||||<|0.001|||||||Incidence rate R|||A test of the incidence rate R was performed with null hypothesis H0: R>= 0.33 and alternative hypothesis Ha: R<0.33 with a one-sided significance level of 0.05. If the test statistic was negative (actual incidence rate was <0.33), the one-sided p-value for the null hypothesis R>=0.33 was presented. The null hypothesis was rejected if the statistic was negative and the corresponding p-value for the one-sided test was <0.5.|
1632376|NCT02068599|2999165|Superiority||Odds Ratio (OR)|1.45||||0.1532|2-Sided|95.0|0.87|2.423||5% level of significance|generalized estimating equation (GEE)|||For the responder analyses, participants with missing values were deemed non-responders. Analysis performed using a generalized estimating equation (GEE) method where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment*week as explanatory factors. The unstructured working correlation structure was applied.|
1632377|NCT02068599|2999165|Superiority||Odds Ratio (OR)|0.85||||0.5358|2-Sided|95.0|0.501|1.433||5% level of significance|generalized estimating equation (GEE)|||For the responder analyses, participants with missing values were deemed non-responders. Analysis performed using a generalized estimating equation (GEE) method where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment*week as explanatory factors. The unstructured working correlation structure was applied.|
1632378|NCT02068599|2999166|Superiority||LSM difference from placebo|1.74||||0.532|2-Sided|95.0|-3.721|7.193||5% level of significance|mixed model for repeated measures|||Week 4|
1632379|NCT02068599|2999166|Superiority||LSM difference from placebo|0.82||||0.7699|2-Sided|95.0|-4.678|6.315||5% level of significance|mixed model for repeated measures|||Week 4|
1632380|NCT02068599|2999166|Superiority||LSM difference from placebo|1.41||||0.5892|2-Sided|95.0|-3.707|6.518||5% level of significance|mixed model for repeated measures|||Week 2|
1632381|NCT02068599|2999166|Superiority||LSM difference from placebo|2.77||||0.2906|2-Sided|95.0|-2.377|7.916||5% level of significance|mixed model for repeated measures|||Week 2|
1632382|NCT02068599|2999167|Superiority||LSM difference from placebo|0.06||||0.6357|2-Sided|95.0|-0.204|0.334||5% level of significance|mixed model for repeated measures|||Week 4|
1632383|NCT02068599|2999167|Superiority||LSM difference from placebo|0.21||||0.1199|2-Sided|95.0|-0.056|0.486||5% level of significance|mixed model for repeated measures|||Week 4|
1632384|NCT02068599|2999167|Superiority||LSM difference from placebo|0.04||||0.7344|2-Sided|95.0|-0.2|0.284||5% level of significance|mixed model for repeated measures|||Week 2|
1632386|NCT02068599|2999168|Superiority||LSM difference from placebo|2.51||||0.6126|2-Sided|95.0|-7.24|12.26||5% level of significance|mixed model for repeated measures||||
1632387|NCT02068599|2999168|Superiority||LSM difference from placebo|3.94||||0.4316|2-Sided|95.0|-5.9|13.79||5% level of significance|mixed model for repeated measures||||
1632388|NCT02068599|2999169|Superiority||Odds Ratio (OR)|0.87||||0.5777|2-Sided|95.0|0.52|1.441||5% level of significance|mixed model for repeated measures|||>=30% responder rate|
1632389|NCT02068599|2999169|Superiority||Odds Ratio (OR)|0.89||||0.6607|2-Sided|95.0|0.531|1.494||5% level of significance|mixed model for repeated measures|||>=30% responder rate|
1632390|NCT02068599|2999169|Superiority||Odds Ratio (OR)|1.06||||0.84|2-Sided|95.0|0.615|1.819||5% level of significance|mixed model for repeated measures|||>=50% responder rate|
1632391|NCT02068599|2999169|Superiority||Odds Ratio (OR)|0.62||||0.1011|2-Sided|95.0|0.345|1.099||5% level of significance|mixed model for repeated measures|||>=50% responder rate|
1632392|NCT02068599|2999170|Superiority||LSM difference from placebo|-3.48||||0.5775|2-Sided|95.0|-15.78|8.81||5% level of significance|mixed model for repeated measures||||
1632393|NCT02068599|2999170|Superiority||LSM difference from placebo|3.16||||0.6184|2-Sided|95.0|-9.31|15.63||5% level of significance|mixed model for repeated measures||||
1632394|NCT02068599|2999171|Superiority||LSM difference from placebo|-50.4||||0.3141|2-Sided|95.0|-148.72|47.92||5% level of significance|mixed model for repeated measures||||
1632395|NCT02068599|2999171|Superiority||LSM difference from placebo|23.51||||0.642|2-Sided|95.0|-75.83|122.84||5% level of significance|mixed model for repeated measures||||
1632396|NCT02068599|2999172|Superiority||LSM difference from placebo|2.06||||0.4584|2-Sided|95.0|-3.39|7.5||5% level of significance|mixed model for repeated measures||||
1632397|NCT02068599|2999172|Superiority||LSM difference from placebo|3.61||||0.1963|2-Sided|95.0|-1.87|9.08||5% level of significance|mixed model for repeated measures||||
1632398|NCT02068599|2999173|Superiority||LSM difference from placebo|9.0||||0.4956|2-Sided|95.0|-16.95|34.96||5% level of significance|mixed model for repeated measures|||LSM = least square mean|
1632399|NCT02068599|2999173|Superiority||LSM difference from placebo|17.86||||0.1795|2-Sided|95.0|-8.26|43.98||5% level of significance|mixed model for repeated measures|||LSM = least square mean|
1632400|NCT02068599|2999174|Superiority||LSM difference from placebo|1.74||||0.5231|2-Sided|95.0|-3.62|7.11||5% level of significance|mixed model for repeated measures|||LSM = least square mean|
1632401|NCT02068599|2999174|Superiority||LSM difference from placebo|4.26||||0.1213|2-Sided|95.0|-1.13|9.66||5% level of significance|mixed model for repeated measures|||LSM = least square mean|
1632402|NCT02068443|2999200|Non-Inferiority or Equivalence|Non-inferiority of Alogliptin + Metformin Hydrochloride QD to Alogliptin + Metformin Hydrochloride BID.|LS Mean Difference|0.11|Standard Error of the Mean|0.069|||2-Sided|95.0|-0.026|0.247|||||Estimated Value was for the difference between Alogliptin + Metformin Hydrochloride QD and Alogliptin + Metformin Hydrochloride BID (Metformin QD - Metformin BID).||
1632403|NCT02068443|2999200|Superiority or Other||LS Mean Difference|-0.65|Standard Error of the Mean|0.087|||2-Sided|95.0|-0.821|-0.48|||||Estimated Value was for the difference between Alogliptin + Metformin Hydrochloride QD and Alogliptin alone (Metformin QD - Alogliptin alone).||
1632404|NCT02068027|2999207|Superiority|||||||0.735||||||MMRM imputing for missing data|Mixed Models Analysis||||
1632405|NCT02068027|2999208|Superiority|||||||0.4503||||||MMRM imputing for missing data|Mixed Models Analysis||||
1632406|NCT02067728|2999212|Superiority or Other|||||||0.588|||||||t-test, 2 sided||||
1632407|NCT02067728|2999213|Superiority or Other|||||||0.4835|||||||t-test, 2 sided||||
1632408|NCT02067728|2999216|Superiority or Other||Risk Ratio (RR)|2.9|||<|0.0001|2-Sided|95.0|2.0|4.5|||Chi-squared||||
1632409|NCT02067728|2999217|Superiority or Other||Risk Ratio (RR)|3.3|||<|0.0001|2-Sided|95.0|2.2|4.9|||Chi-squared||||
1632410|NCT02067728|2999218|Superiority or Other|||||||1|||||||Chi-squared||||
1632411|NCT02067728|2999219|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1632412|NCT02067728|2999220|Superiority or Other||Mean Difference (Net)|-0.26|Standard Deviation|0.42|<|0.05|2-Sided||||||t-test, 2 sided||||
1632413|NCT02067728|2999221|Superiority or Other|||||||0.3875|||||||t-test, 2 sided||||
1632414|NCT02067728|2999222|Superiority or Other|||||||0.0029|||||||Chi-squared||||
1632415|NCT02066896|2999278|Other|ANOVA repeated measures||||||0.05|||||||ANOVA|ANOVA repeated measures|||
1632416|NCT02066467|2999290|Other||||||<|0.0001|||||||exact binominal methodology||||
1632417|NCT02066467|2999292|Other||||||<|0.0001|||||||exact binominal methodology||||
1632418|NCT02066415|2999295|Superiority|This comparison was tested at a 2-sided significance level of 0.01.|Difference in LS Means|-19.31||||0.03|2-Sided|95.0|-36.71|-1.92|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.|
1632419|NCT02066415|2999295|Superiority|This comparison was tested at a 2-sided significance level of 0.04.|Difference in LS Means|-9.54||||0.28|2-Sided|95.0|-26.98|7.9|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.|
1632420|NCT02066415|2999296|Superiority|This comparison was tested at a 2-sided significance level of 0.01.|Difference in LS Means|-2.55|||<|0.001|2-Sided|95.0|-3.28|-1.82|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.|
1632421|NCT02066415|2999296|Superiority|This comparison was tested at a 2-sided significance level of 0.04.|Difference in LS Means|-1.86|||<|0.001|2-Sided|95.0|-2.6|-1.13|||Generalized linear mixed model|||Analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.|
1632859|NCT02057757|3000269|Superiority|||||||0.0446||||||Nasal Discharge|Fay-Shaw||||
1632422|NCT02066415|2999297|Superiority|This comparison was tested at a 2-sided significance level of 0.01.|Odds Ratio (OR)|2.34|||<|0.001|2-Sided|95.0|1.56|3.51|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).|
1632423|NCT02066415|2999297|Superiority|This comparison was tested at a 2-sided significance level of 0.04.|Odds Ratio (OR)|2.18|||<|0.001|2-Sided|95.0|1.46|3.27|||Cochran-Mantel-Haenszel|||Analyzed using a Cochran-Mantel-Haenszel test after the missing data were imputed as non-response, stratified by stratification factors (region and medication overuse status).|
1632424|NCT02066415|2999298|Superiority|"A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the 2 erenumab doses and the primary and secondary endpoints.~This comparison was tested at a 2-sided significance level of 0.01."|Difference in LS Means|-2.45|||<|0.001|2-Sided|95.0|-3.51|-1.38|||Generalized linear mixed model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.|
1632425|NCT02066415|2999298|Superiority|"A sequential testing procedure, specifically, the hierarchical gate-keeping procedures and Hochberg method, was used to maintain the 2-sided study-wise type I error at 0.05 between the 2 erenumab doses and the primary and secondary endpoints.~This comparison was tested at a 2-sided significance level of 0.04."|Difference in LS Means|-2.46|||<|0.001|2-Sided|95.0|-3.52|-1.39|||Generalized linear mixed model|||The primary endpoint was analyzed using a linear mixed effects model including treatment group, baseline value, stratification factors (region and medication overuse status), scheduled visit, and the interaction of treatment group with scheduled visit.|
1632426|NCT02066402|2999305|Non-Inferiority or Equivalence|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-3.1|||||2-Sided|95.0|-8.4|2.0|||||||
1632427|NCT02066402|2999306|Non-Inferiority or Equivalence|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.2|||||2-Sided|95.0|-8.6|4.1|||||||
1632428|NCT02066402|2999307|Non-Inferiority or Equivalence|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.1|||||2-Sided|95.0|-7.4|3.2|||||||
1632429|NCT02066402|2999308|Non-Inferiority or Equivalence|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance.|Difference of responder rate|-2.2|||||2-Sided|95.0|-8.3|3.8|||||||
1632430|NCT02066402|2999309|Non-Inferiority or Equivalence|The non-inferiority (NI) hypothesis test is a 1-sided hypothesis test performed at the 2.5% level of significance. Predefined margin for non-inferiority is -10%.|Difference of responder rate|-4.6||||0.2027|2-Sided|95.0|-11.2|2.2|||Fisher Exact||||
1632431|NCT02066389|2999310|Superiority|||||||1||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632432|NCT02066389|2999310|Superiority|||||||0.16||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632433|NCT02066389|2999310|Superiority|||||||1||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632434|NCT02066389|2999310|Superiority|||||||0.16||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632435|NCT02066389|2999310|Superiority|||||||0.269||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632436|NCT02066389|2999311|Superiority|||||||0.096||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632437|NCT02066389|2999311|Superiority|||||||0.005||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632438|NCT02066389|2999311|Superiority|||||||0.046||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632439|NCT02066389|2999311|Superiority|||||||0.039||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632440|NCT02066389|2999311|Superiority|||||||0.039||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632441|NCT02066389|2999312|Superiority|||||||0.343||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632442|NCT02066389|2999312|Superiority|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632443|NCT02066389|2999312|Superiority|||||||0.029||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632444|NCT02066389|2999312|Superiority|||||||0.008||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632445|NCT02066389|2999312|Superiority|||||||0.015||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632446|NCT02066389|2999313|Superiority|||||||0.024||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact||||
1632447|NCT02066389|2999313|Superiority|||||||0.002||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact||||
1632448|NCT02066389|2999313|Superiority|||||||0.01||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact||||
1632449|NCT02066389|2999313|Superiority||||||<|0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact||||
1632450|NCT02066389|2999313|Superiority||||||<|0.005||||||Statistical tests were 1-sided at a significance level of 0.05.|Fisher Exact||||
1632451|NCT02066389|2999314|Superiority|||||||0.014||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632452|NCT02066389|2999314|Superiority|||||||0.007||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632453|NCT02066389|2999314|Superiority|||||||0.145||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632454|NCT02066389|2999314|Superiority|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632455|NCT02066389|2999314|Superiority|||||||0.023||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632457|NCT02066389|2999315|Superiority|||||||0.01||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632458|NCT02066389|2999315|Superiority|||||||0.002||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632459|NCT02066389|2999315|Superiority|||||||0.003||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632460|NCT02066389|2999315|Superiority|||||||0.034||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632461|NCT02066389|2999316|Superiority|||||||0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632462|NCT02066389|2999316|Superiority|||||||0.008||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632463|NCT02066389|2999316|Superiority|||||||0.001||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632464|NCT02066389|2999316|Superiority|||||||0.018||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632465|NCT02066389|2999316|Superiority|||||||0.153||||||Statistical tests were 1-sided at a significance level of 0.05.|Chi-squared||||
1632466|NCT02066298|2999323|Superiority|||||||0.45||||||this analysis is considered exploratory|exact binomial test|||The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. This was an exploratory analysis and there were no power considerations.|
1632467|NCT02066298|2999323|Superiority|||||||0.001||||||this analysis is considered exploratory|exact binomial test|||The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. This was an exploratory analysis and there were no power considerations.|
1632468|NCT02066298|2999323|Superiority|||||||0.029||||||a priori threshold for significance was 0.025|exact binomial test|||The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025.|
1632469|NCT02066298|2999323|Superiority|||||||0.14|||||||exact binomial test|a priori threshold for significance was 0.025||The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025.|
1632470|NCT02066181|2999343|Superiority||Hazard Ratio (HR)|11.3|||<|0.001|1-Sided|95.0|5.7||||Log Rank||||
1632471|NCT02065895|2999352|Other|||||||0.0059|||||||ANOVA||||
1632472|NCT02065895|2999353|Other|ANOVA was used to first tests the hypothesis that there is a difference among the three groups.|Mean Difference (Final Values)|66.8||||0.0011|2-Sided|95.0|33.4|80.3||The p value was adjusted for multiple comparisons using Sidak’s correction. A priori the pimary outcome was defined as blood glucose AUC from 8 am - 12pm; however we used blood glucose AUC from 8am - 2pm to capture the entire meal response.|ANOVA|||Differences among the 3 groups were assessed by repeated measures ANOVA using Sidak’s correction for multiple comparisons. All subjects were analyzed as a single group, no comparison group.|
1632473|NCT02065791|2999354|Superiority||Hazard Ratio (HR)|0.74||||0.0001|2-Sided|95.0|0.63|0.86|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.|
1632474|NCT02065791|2999355|Superiority||Hazard Ratio (HR)|0.83|||=|0|2-Sided|95.0|0.68|1.02|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.|
1632475|NCT02065791|2999356|Superiority||Hazard Ratio (HR)|0.78|||=|0|2-Sided|95.0|0.61|1.0|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.|
1632476|NCT02065791|2999357|Superiority||Hazard Ratio (HR)|0.66|||<|0.0001|2-Sided|95.0|0.53|0.81|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.|
1632477|NCT02065791|2999358|Superiority||Hazard Ratio (HR)|0.61|||=|0|2-Sided|95.0|0.47|0.8|||Cox proportional hazards|||Comparison for canagliflozin versus placebo is reported here.|
1632478|NCT02065791|2999359|Superiority||Hazard Ratio (HR)|0.8|||=|0|2-Sided|95.0|0.67|0.95|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.|
1632479|NCT02065791|2999360|Superiority||Hazard Ratio (HR)|0.69|||=|0|2-Sided|95.0|0.57|0.83|||Cox proportional hazard|||Comparison for canagliflozin versus placebo is reported here.|
1632480|NCT02065791|2999361|Superiority||Hazard Ratio (HR)|0.7|||<|0.0001|2-Sided|95.0|0.59|0.82|||Cox Proportional Hazard|||Comparison for canagliflozin versus placebo is reported here.|
1632481|NCT02065453|2999373|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The data will be analyzed using linear regression, Kolmogorov-Smirnov test, and chi-square analysis.|
1632482|NCT02064920|2999440|Superiority or Other||Change in SD from Week 4 to Week 16|0.005|||||2-Sided|95.0|-0.031|0.039|||||SD of average OCL repeated measurements after 12 weeks of treatment for Placebo + Donezepil treatment groups combined is hypothesized to be ≤ 0.1.|Change from Week 4 to Week 16 in Standard Deviation (SD) of OCL for Placebo + Donezepil treatment groups combined|
1632483|NCT02064894|2999448|Superiority or Other|||||||0.81|||||||Cochran-Mantel-Haenszel||||
1632484|NCT02064868|2999449|Superiority|||||||0.1236|||||||Mixed Models Analysis|||Day 14|
1632485|NCT02064868|2999449|Superiority|||||||0.3115|||||||Mixed Models Analysis|||Day 5|
1632486|NCT02064868|2999451|Superiority|||||||0.1392|||||||Wilcoxon (Mann-Whitney)||||
1632487|NCT02064868|2999452|Superiority|||||||0.0002|||||||Chi-squared||||
1632488|NCT02064868|2999453|Superiority||||||<|0.0001|||||||Chi-squared||||
1632489|NCT02064868|2999454|Superiority||Hazard Ratio (HR)|0.79||||0.0634|2-Sided|95.0|0.61|1.02||Two-sided p-value|Gehan’s generalized Wilcoxon test||||
1632490|NCT02064868|2999455|Superiority||Hazard Ratio (HR)|0.71||||0.0172|2-Sided|95.0|0.51|0.98||One-sided p-value|Gehan’s generalized Wilcoxon test||||
1632491|NCT02064816|2999470|Superiority or Other||LS Mean difference|-0.2224||||0.1502|2-Sided|95.0|-0.5256|0.0809|||linear mixed model for repeated measures|||Rating of pain: Week 12|
1632492|NCT02064816|2999470|Superiority or Other||LS Mean difference|-0.08689||||0.5715|2-Sided|95.0|-0.3886|0.2148|||linear mixed model for repeated measures|||Rating of pain: Week 8|
1632493|NCT02064816|2999470|Superiority or Other||LS Mean difference|0.006873||||0.9639|2-Sided|95.0|-0.2918|0.3055|||linear mixed model for repeated measures|||Rating of pain: Week 4|
1632494|NCT02064816|2999470|Superiority or Other||LS Mean difference|-5.4196||||0.0852|2-Sided|95.0|-11.5939|0.7547|||linear mixed model for repeated measures|||VAS: Week 12|
1632495|NCT02064816|2999470|Superiority or Other||LS Mean difference|-2.2294||||0.4764|2-Sided|95.0|-8.38|3.9212|||linear mixed model for repeated measures|||VAS: Week 8|
1632496|NCT02064816|2999470|Superiority or Other||LS Mean difference|0.6544||||0.8328|2-Sided|95.0|-5.4393|6.7482|||linear mixed model for repeated measures|||VAS: Week 4|
1632497|NCT02064816|2999470|Superiority or Other||LS Mean difference|0.1422||||0.869|2-Sided|95.0|-1.5521|1.8364|||linear mixed model for repeated measures|||Description of pain: Week 12|
1632498|NCT02064816|2999470|Superiority or Other||LS Mean difference|-0.7689||||0.3719|2-Sided|95.0|-2.4607|0.9229|||linear mixed model for repeated measures|||Description of pain: Week 8|
1632499|NCT02064816|2999470|Superiority or Other||LS Mean difference|0.5909||||0.489|2-Sided|95.0|-1.0873|2.269|||linear mixed model for repeated measures|||Description of pain: Week 4|
1632500|NCT02064816|2999470|Superiority or Other||LS Mean difference|-0.05809||||0.8217|2-Sided|95.0|-0.5651|0.4489|||linear mixed model for repeated measures|||Benefits: Week 12|
1632501|NCT02064816|2999470|Superiority or Other||LS Mean difference|-0.1358||||0.594|2-Sided|95.0|-0.637|0.3653|||linear mixed model for repeated measures|||Benefits: Week 8|
1632502|NCT02064816|2999470|Superiority or Other||LS Mean difference|-0.4083||||0.1038|2-Sided|95.0|-0.9008|0.08419|||linear mixed model for repeated measures|||Benefits: Week 4|
1632503|NCT02064816|2999470|Superiority or Other||LS Mean difference|0.4097||||0.3042|2-Sided|95.0|-0.3734|1.1929|||linear mixed model for repeated measures|||Global side-effect subscale: Week 12|
1632504|NCT02064816|2999470|Superiority or Other||LS Mean difference|0.1897||||0.6338|2-Sided|95.0|-0.5926|0.972|||linear mixed model for repeated measures|||Global side-effect subscale: Week 8|
1632505|NCT02064816|2999470|Superiority or Other||LS Mean difference|-0.07079||||0.8574|2-Sided|95.0|-0.8452|0.7036|||linear mixed model for repeated measures|||Global side-effect subscale: Week 4|
1632506|NCT02064816|2999470|Superiority or Other||LS Mean difference|-0.3245||||0.5099|2-Sided|95.0|-1.2927|0.6437|||linear mixed model for repeated measures|||ISRs subscale Week 12|
1632507|NCT02064816|2999470|Superiority or Other||LS Mean difference|0.08479||||0.8635|2-Sided|95.0|-0.885|1.0546|||linear mixed model for repeated measures|||ISRs subscale Week 8|
1632508|NCT02064816|2999470|Superiority or Other||LS Mean difference|0.4003||||0.4311|2-Sided|95.0|-0.5992|1.3998|||linear mixed model for repeated measures|||ISRs subscale Week 4|
1632509|NCT02064816|2999471|Superiority or Other||LS Mean difference|1.3367||||0.0079|2-Sided|95.0|0.3534|2.32|||linear mixed model for repeated measures|||Week 8|
1632510|NCT02064816|2999471|Superiority or Other||Least Square (LS) Mean difference|1.3492||||0.0083|2-Sided|95.0|0.3495|2.3489|||linear mixed model for repeated measures|||Week 4|
1632511|NCT02064816|2999472|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Deviation|3.5||0.277763|2-Sided|95.0|-0.46|1.56|||Mann-Whitney Non Parametric test||||
1632512|NCT02064439|2999473|Superiority or Other||Hazard Ratio (HR)|1.46||||0.3137|2-Sided|95.0|0.7|3.06||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test||||
1632513|NCT02064439|2999473|Superiority or Other||Hazard Ratio (HR)|0.99||||0.9726|2-Sided|95.0|0.44|2.2||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test||||
1632514|NCT02064439|2999473|Superiority or Other||Hazard Ratio (HR)|1.44||||0.3318|2-Sided|95.0|0.69|3.02||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test||||
1632515|NCT02064439|2999474|Superiority or Other||Hazard Ratio (HR)|1.08||||0.8172|2-Sided|95.0|0.57|2.06||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.|
1632516|NCT02064439|2999474|Superiority or Other||Hazard Ratio (HR)|0.32|||<|0.0001|2-Sided|95.0|0.19|0.54||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.|
1632517|NCT02064439|2999474|Superiority or Other||Hazard Ratio (HR)|0.34|||<|0.0001|2-Sided|95.0|0.2|0.57||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.|
1632518|NCT02064439|2999475|Superiority or Other||Hazard Ratio (HR)|1.23||||0.7337|2-Sided|95.0|0.37|4.03||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.|
1632519|NCT02064439|2999475|Superiority or Other||Hazard Ratio (HR)|1.64||||0.5005|2-Sided|95.0|0.39|6.84||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.|
1632520|NCT02064439|2999475|Superiority or Other||Hazard Ratio (HR)|2.01||||0.3235|2-Sided|95.0|0.5|8.04||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.|
1632560|NCT02063698|2999607|Superiority|||||||0.44|||||||Fisher Exact|||Day 8: BPI Worst Pain Past 24 Hours|
1632561|NCT02063698|2999607|Superiority|||||||1|||||||Fisher Exact|||Day 7: BPI Worst Pain Past 24 Hours|
1632521|NCT02064439|2999476|Superiority or Other||Hazard Ratio (HR)|1.34||||0.4328|2-Sided|95.0|0.65|2.75||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.|
1632522|NCT02064439|2999476|Superiority or Other||Hazard Ratio (HR)|0.26|||<|0.0001|2-Sided|98.0|0.14|0.47||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.|
1632523|NCT02064439|2999476|Superiority or Other||Hazard Ratio (HR)|0.34|||<|0.0001|2-Sided|95.0|0.2|0.59||P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).|Wald test|||Statistical analysis was performed on the first occurrence of the composite outcome.|
1632524|NCT02064205|2999545|Superiority or Other|||||||0.0216||||||GLP-1|Mixed Models Analysis|||A mixed model was applied to statistically analyze satiety hormones having Conditions and Time as a fixed factor and having Subject, Cohort, and Treatment Day as random factors.|
1632525|NCT02064205|2999546|Superiority or Other|||||||0.0109|||||||Mixed Models Analysis|||AUC of hunger scores before preload intake for condition C versus D.|
1632526|NCT02064205|2999547|Superiority or Other||Mean Difference (Final Values)|18.0|Standard Deviation|1000.0||0.2918|1-Sided||||||Mixed Models Analysis|||A mixed model was applied to analyze the Energy Intakes (ad libitum lunch and daily) were done one-sided to evaluate the appetite suppressive effect after the pre-load snack (condition C versus D)|
1632527|NCT02063867|2999558|Superiority|||||||0.0032||||||Remained significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals|||
1632528|NCT02063867|2999559|Superiority|||||||0.002||||||Remained significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals|||
1632529|NCT02063867|2999560|Superiority|||||||0.0126||||||Remains significant after adjusting for multiple comparisons|Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals|||
1632530|NCT02063867|2999561|Superiority||||||<|0.001|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals|||
1632531|NCT02063867|2999568|Superiority|||||||0.43|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals|||
1632532|NCT02063867|2999569|Superiority|||||||0.16|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals|||
1632533|NCT02063867|2999570|Superiority|||||||0.17|||||||Mixed Models Analysis|Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals|||
1632534|NCT02063854|2999581|Superiority or Other||Mean Difference (Final Values)|0.75|||||2-Sided|95.0|-0.166|1.658|||||||
1632535|NCT02063854|2999581|Superiority or Other||Mean Difference (Final Values)|-1.71|||||2-Sided|95.0|-2.617|-0.794|||||||
1632536|NCT02063854|2999581|Superiority or Other||Mean Difference (Final Values)|-0.96|||||2-Sided|95.0|-1.92|0.001|||||||
1632537|NCT02063854|2999581|Non-Inferiority or Equivalence|Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.||||||0.6711|||||||t-test, 1 sided|With a non-inferiority margin (Δ) of 1.5%.|||
1632538|NCT02063854|2999581|Non-Inferiority or Equivalence|Non-inferiority was tested using t-test at a one-sided significance level of 2.5% and a non-inferiority margin (Δ) of 1.5%.||||||0.1346|||||||t-test, 1 sided|With a non-inferiority margin (Δ) of 1.5%.|||
1632539|NCT02063737|2999582|Superiority or Other|||||||0.2|||||||ANCOVA|adjusting for baseline measure|||
1632540|NCT02063737|2999583|Superiority or Other|||||||0.56|||||||ANCOVA|adjusting for baseline measure|||
1632541|NCT02063737|2999584|Superiority or Other|||||||0.093|||||||ANCOVA|adjusting for baseline measure|||
1632542|NCT02063737|2999585|Superiority or Other|||||||0.28|||||||ANCOVA|adjusting for baseline measure|||
1632543|NCT02063737|2999586|Superiority or Other|||||||0.51|||||||ANCOVA|adjusting for baseline measure|||
1632544|NCT02063737|2999587|Superiority or Other|||||||0.21|||||||ANCOVA|adjusting for baseline measure|||
1632545|NCT02063737|2999588|Superiority or Other|||||||0.95|||||||ANCOVA|adjusting for baseline measure|||
1632546|NCT02063737|2999589|Superiority or Other|||||||0.65|||||||ANCOVA|adjusting for baseline measure|||
1632547|NCT02063737|2999590|Superiority or Other|||||||0.69|||||||ANCOVA|adjusting for baseline measure|||
1632548|NCT02063737|2999591|Superiority or Other|||||||0.0578|||||||ANCOVA|adjusting for the baseline measure|||
1632549|NCT02063737|2999592|Superiority or Other|||||||0.0927|||||||ANCOVA|adjusted for baseline measure|||
1632550|NCT02063737|2999593|Superiority or Other|||||||0.99|||||||ANCOVA|adjusting for the baseline measure|||
1632551|NCT02063737|2999594|Superiority or Other|||||||0.0114|||||||ANCOVA|adjusting for baseline measure|||
1632552|NCT02063737|2999595|Superiority or Other||Median Difference (Final Values)|-0.3882||||0.083|2-Sided|95.0|-0.8272|0.0508|||Mixed Models Analysis|adjusting for shift length|Adjusted difference between intervention groups (intervention - control) from the linear mixed model adjusting for shift length and repeated measures within individuals.||
1632553|NCT02063698|2999599|Superiority|||||||0.04|||||||Chi-squared||||
1632554|NCT02063698|2999600|Superiority|||||||0.01|||||||Chi-squared||||
1632555|NCT02063698|2999601|Superiority|||||||0.02|||||||Chi-squared||||
1632556|NCT02063698|2999602|Superiority|||||||0.01|||||||Chi-squared||||
1632557|NCT02063698|2999603|Superiority|||||||0.025|||||||Chi-squared||||
1632558|NCT02063698|2999605|Superiority|||||||0.13|||||||Equal variance t-test||||
1632559|NCT02063698|2999606|Superiority|||||||0.44|||||||Equal variance t-test||||
1632563|NCT02063698|2999607|Superiority|||||||0.12|||||||Fisher Exact|||Day 5: BPI Worst Pain Past 24 Hours|
1632564|NCT02063698|2999607|Superiority|||||||0.38|||||||Fisher Exact|||Day 4: BPI Worst Pain Past 24 Hours|
1632565|NCT02063698|2999607|Superiority|||||||0.45|||||||Fisher Exact|||Day 3: BPI Worst Pain Past 24 Hours|
1632566|NCT02063698|2999607|Superiority|||||||1|||||||Fisher Exact|||Day 2: BPI Worst Pain Past 24 Hours|
1632567|NCT02063659|2999635|Superiority||Hodges-Lehman estimator of difference|-89.662|||<|0.001|2-Sided|95.0|-113.104|-63.863|||Wilcoxon rank sum|||The primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the u5-HIAA at randomization.|Mean difference is calculated as LX1606-Placebo.
1632568|NCT02063659|2999635|Superiority||Hodges-Lehman estimator of difference|-53.955|||<|0.001|2-Sided|95.0|-84.955|-25.119|||Wilcoxon rank sum|||The primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the u5-HIAA at randomization.|Mean difference is calculated as LX1606-Placebo.
1632569|NCT02063516|2999637|Superiority or Other|||||||0.004|||||||t-test, 2 sided|||Amount of air added at 120 minutes to maintain cuff pressure 60cmH2O|
1632570|NCT02063516|2999637|Superiority or Other|||||||0.0042|||||||t-test, 2 sided|||Amount of air added at 90 minutes to maintain cuff pressure 60cmH2O|
1632571|NCT02063516|2999637|Superiority or Other|||||||0.003|||||||t-test, 2 sided|||Amount of air added at 60 minutes to maintain cuff pressure 60cmH2O|
1632572|NCT02063516|2999637|Superiority or Other|||||||0.0035|||||||t-test, 2 sided|||Amount of air added at 30 minutes to maintain cuff pressure 60cmH2O|
1632573|NCT02063516|2999638|Superiority or Other|||||||0.836|||||||Chi-squared||||
1632574|NCT02063516|2999639|Superiority or Other|||||||0.04|||||||t-test, 2 sided|||It was calculated that 80 adult patients randomized from different surgical department would have 80% power to detect a difference in 2 point in mean. Sampling size was determined using 2 sided t-test (alpha=0.05).|
1632575|NCT02063217|2999646|Superiority|Mixed linear models|Mean Difference (Net)|7.0||||1|2-Sided|||||Bonferroni correction was used for multiple comparisons.|Mixed Models Analysis||Mean= 7%, standard error = 7.6%. 7% increase in overnight amyloid beta 40 concentrations over the waking baseline between the sleep induction group and control group.|Mixed linear modeling of change in overnight amyloid beta concentrations from waking baseline between 01:00 and 11:00. Data provided for amyloid beta-40.|
1632576|NCT02063217|2999646|Superiority|Mixed linear models|Mean Difference (Net)|17.0||||0.07|2-Sided|||||Bonferroni correction was used for multiple comparisons.|Mixed Models Analysis||Mean (standard error), units = %. 17(7.2) increase in overnight amyloid-beta 40 concentrations over waking baseline between the sleep deprivation group and controls.|Mixed linear modeling of change in overnight amyloid beta concentrations from waking baseline between 01:00 and 11:00. Data provided for amyloid beta-40.|
1632577|NCT02063178|2999647|Other||||||<|0.0001|||||||Correlation||||
1632578|NCT02063178|2999648|Other||||||<|0.0001|||||||Correlation||||
1632579|NCT02063178|2999649|Other|Correlation|||||<|0.0001|||||||Correlation|||The association between weight change percent and attendance was described using Spearman rank correlation.|
1632580|NCT02063178|2999650|Superiority||Mean Difference (Final Values)|2.1|||<|0.001|2-Sided||||||Wilcoxon (Mann-Whitney)|||This randomized clinical trial was designed to have 90% power to detect a 4% weight loss percent difference at 12 months between the two study arms.|
1632581|NCT02063035|2999663|Superiority|||||||0.1318|||||||Wilcoxon (Mann-Whitney)||||
1632582|NCT02062801|2999669|Superiority or Other|||||||0.56|||||||Chi-squared||||
1632583|NCT02062801|2999670|Superiority or Other|||||||0.97|||||||Chi-squared||||
1632584|NCT02062801|2999671|Superiority or Other|||||||0.18|||||||Chi-squared||||
1632585|NCT02062502|2999693|Superiority or Other||Antibody Response Rate|97.2|||<|0.001|2-Sided|95.0|94.4|98.9|||Exact CI method/binomial proportion|||The conclusion of acceptability is based on the lower bound of the 95% Confidence Interval (CI) being >76%, and implies that the value of the parameter is statistically significantly greater than the prespecified acceptability criterion (76%).|
1632586|NCT02062502|2999693|Non-Inferiority or Equivalence|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on fold-difference, excluding a decrease of 1.5 fold or more.|Risk Difference (RD)|0.95|||<|0.001|2-Sided|95.0|0.85|1.06|||t-test, 2 sided||||
1632587|NCT02062502|2999694|Non-Inferiority or Equivalence|The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus.|Risk Difference (RD)|0.0|||<|0.001|2-Sided|95.0|-3.2|3.2|||Miettinen and Nurminen||||
1632588|NCT02062385|2999719|Superiority or Other||1 - (Incidence V260 / Incidence Placebo)|69.3|||<|0.001|2-Sided|95.0|54.5|79.7|||Clopper-Pearson|To calculate the confidence interval and associated p-value, an exact conditional method based on a Poisson distribution was used.||V260 will be considered efficacious if the lower bound of the two-sided confidence interval for efficacy is >0% at the final analysis|
1632589|NCT02061748|2999748|Superiority or Other|||||||0.0004|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632590|NCT02061748|2999749|Superiority or Other|||||||0.0004|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632591|NCT02061748|2999750|Superiority or Other|||||||0.2646|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632592|NCT02061748|2999751|Superiority or Other|||||||0.0003|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632593|NCT02061748|2999752|Superiority or Other|||||||0.5331|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632594|NCT02061748|2999753|Superiority or Other|||||||0.0023|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632595|NCT02061748|2999754|Superiority or Other|||||||0.2083|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632596|NCT02061748|2999755|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632597|NCT02061748|2999756|Superiority or Other|||||||0.8017|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632598|NCT02061748|2999757|Superiority or Other|||||||0.2665|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632599|NCT02061748|2999758|Superiority or Other|||||||0.4407|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632600|NCT02061748|2999759|Superiority or Other|||||||0.261|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632601|NCT02061748|2999760|Superiority or Other|||||||0.0138|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632602|NCT02061748|2999761|Superiority or Other|||||||0.0185|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632603|NCT02061748|2999762|Superiority or Other||||||<|0.0001|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632604|NCT02061748|2999763|Superiority or Other|||||||0.0006|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632605|NCT02061748|2999764|Superiority or Other|||||||0.8465|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632606|NCT02061748|2999765|Superiority or Other|||||||0.9573|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632607|NCT02061748|2999766|Superiority or Other|||||||0.3055|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632608|NCT02061748|2999767|Superiority or Other|||||||0.1534|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632609|NCT02061748|2999768|Superiority or Other|||||||0.8208|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632610|NCT02061748|2999769|Superiority or Other|||||||0.907|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632611|NCT02061748|2999770|Superiority or Other|||||||0.0284|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632612|NCT02061748|2999771|Superiority or Other|||||||0.0055|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632613|NCT02061748|2999772|Superiority or Other|||||||0.0072|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632614|NCT02061748|2999773|Superiority or Other|||||||0.0749|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632615|NCT02061748|2999774|Superiority or Other|||||||0.0271|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632616|NCT02061748|2999775|Superiority or Other|||||||0.0068|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632617|NCT02061748|2999776|Superiority or Other|||||||0.3502|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632618|NCT02061748|2999777|Superiority or Other|||||||0.0808|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632619|NCT02061748|2999778|Superiority or Other|||||||0.0019|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632620|NCT02061748|2999779|Superiority or Other|||||||0.0011|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632621|NCT02061748|2999780|Superiority or Other|||||||0.0861|||||||Chi-squared|||The post-hoc analysis defined the principal diagnosis as the primary diagnosis on the first inpatient hospital claim with a room and board charge.|
1632622|NCT02061748|2999781|Superiority or Other|||||||0.0111|||||||Chi-squared|||Study outcomes for the primary analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|
1632623|NCT02061540|2999802|Superiority or Other||Mean Difference (Net)|-14.841|Standard Error of the Mean|6.0373||0.0043|2-Sided|95.0|-27.251|-2.432|||Wilcoxon's signed rank test|||Analysis was performed to compare baseline and endpoint data.|
1632624|NCT02060526|2999900|Superiority or Other (legacy)||Difference between proportions|0.143||||1|2-Sided|95.0|-0.423|0.647|||Fisher Exact|||95% exact unconditional confidence interval of the difference in proportion between each of the treatment groups and the untreated control group was considered for the parameter estimation.|
1632625|NCT02060526|2999900|Superiority or Other (legacy)||Difference between proportions|0.286||||0.4615|2-Sided|95.0|-0.297|0.745|||Fisher Exact|||95% exact unconditional confidence interval of the difference in proportion between each of the treatment groups and the untreated control group was considered for the parameter estimation.|
1632626|NCT02060461|2999901|Other|||||||0.003|||||||t-test, 2 sided|||Paired Students t-test of FS200 and IntraLase intraoperative flap thickness measurements obtained by ultrasound pachymetry|
1632627|NCT02060383|2999908|Other|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.36|Standard Error of the Mean|0.19|||2-Sided|95.0|-0.74|0.02|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c <7% vs ≥7%) as fixed effects.|Acromegaly|
1632628|NCT02060383|2999908|Other|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.01|Standard Error of the Mean|0.45|||2-Sided|95.0|-0.96|0.95|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (baseline HbA1c <7% vs ≥7%) as fixed effects.|Cushing's Disease|
1632629|NCT02060383|2999908|Other|There was no formal hypothesis testing planned in this study.|Mean Difference (Net)|-0.28|Standard Error of the Mean|0.18|||2-Sided|95.0|-0.63|0.08|||||Difference of adjusted mean change in HbA1c between the two arms based on an ANOVA model with treatment (Incretin, Insulin) and randomization stratification factors (Cushing's vs. Acromegaly; baseline HbA1c <7% vs ≥7%) as fixed effects.|All Patients|
1632630|NCT02060058|2999917|Other|The evaluation of SVR rate was based on full-analysis-set (FAS) and modified intention-to-treat population (mITT). FAS population included subjects receiving ≥ 1 dose of any antiviral agents (boceprevir and/or PEG-IFN, and/or RBV). MITT population included subjects receiving ≥ 1 dose of boceprevir.||||||0.01|||||||Chi-squared||||
1632631|NCT02059993|2999918|Superiority or Other||Mean Difference (Final Values)|10.0|||<|0.05|2-Sided|95.0|||||t-test, 2 sided|||The sample size was calculated to assess a minimum reduction of 5 ± 5 mm Hg in systolic BPafter CPAP treatment, assuming an alpha error of 5% and a statistical power of 80%.|
1632632|NCT02059980|2999924|Superiority||||||=|0|||||||Mixed Models Analysis|||It was calculated that 30 participants randomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).|
1632633|NCT02059980|2999925|Superiority||||||=|0|||||||Mixed Models Analysis|||It was calculated that 30 participants rnadomized in a 1:1 fashion between the 2 arms would have .90 power to detect a large effect (f=.40), but is somewhat underpowered to detect a medium effect (f=.25) between the two groups. Sample size was determined using a repeated-measures ANOVA test (α = .05, a correlation of .5 among repeated measures, and a nonsphericity correction of .6), considering the design effect and potential patient attrition (=25%).|
1632634|NCT02059642|2999929|Superiority or Other||Least Square Mean Difference|-2.1||||0.1358|2-Sided|95.0|-4.87|0.66|||Mixed Models Analysis|MMRM: Model of Repeated Measures|||
1632635|NCT02059434|2999933|Superiority or Other||Least squares mean difference|0.178|Standard Error of the Mean|0.023|<|0.0001|2-Sided|95.0|0.133|0.223||All statistical comparisons were two-sided hypothesis tests, and the significance level was set at 0.05 without multiplicity adjustment|ANCOVA|||Change from baseline to trough FEV1 was analyzed by means of an analysis of covariance (ANCOVA) for cross-over designs with sequence, treatment group and period as fixed effect factors, subject within sequence as random effect, and screening and baseline FEV1 value of each period as covariates|
1632636|NCT02059434|2999933|Superiority or Other||Least squares mean difference|0.104|Standard Error of the Mean|0.023|<|0.0001|2-Sided|95.0|0.06|0.149||All statistical comparisons were two-sided hypothesis tests, and the significance level was set at 0.05 without multiplicity adjustment|ANCOVA|||Change from baseline to trough FEV1 was analyzed by means of an analysis of covariance (ANCOVA) for cross-over designs with sequence, treatment group and period as fixed effect factors, subject within sequence as random effect, and screening and baseline FEV1 value of each period as covariates|
1632637|NCT02059291|2999940|Superiority||Odds Ratio (OR)|4.5||||0.3571|2-Sided|95.0|0.15|313.49|||Regression, Logistic||||
1632638|NCT02059291|2999940|Superiority||Odds Ratio (OR)|6.0||||0.2168|2-Sided|95.0|0.27|366.24|||Regression, Logistic||||
1632639|NCT02059291|2999940|Superiority||Odds Ratio (OR)|8.17||||0.0513|2-Sided|95.0|0.75|113.44|||Regression, Logistic||||
1632640|NCT02059291|2999941|Superiority||Odds Ratio (OR)|16.69||||0.0235|2-Sided|95.0|1.04|268.5|||Regression, Logistic||||
1632641|NCT02059291|2999941|Superiority||Odds Ratio (OR)|5.26||||0.0778|2-Sided|95.0|0.53|51.97|||Regression, Logistic||||
1632642|NCT02059291|2999941|Superiority||Odds Ratio (OR)|17.46||||0.0286|2-Sided|95.0|0.92|332.92|||Regression, Logistic||||
1632643|NCT02059291|2999942|Superiority||Odds Ratio (OR)|6.64||||0.0149|2-Sided|95.0|1.2|36.57|||Regression, Logistic||||
1632644|NCT02059291|2999942|Superiority||Odds Ratio (OR)|12.71||||0.001|2-Sided|95.0|2.53|63.89|||Regression, Logistic||||
1632645|NCT02059291|2999942|Superiority||Odds Ratio (OR)|29.78|||<|0.0001|2-Sided|95.0|5.86|151.31|||Regression, Logistic||||
1632646|NCT02059291|2999943|Superiority||Odds Ratio (OR)|23.79||||0.0028|2-Sided|95.0|2.52|224.86|||Regression, Logistic||||
1632647|NCT02059291|2999943|Superiority||Odds Ratio (OR)|13.63||||0.0006|2-Sided|95.0|2.83|65.59|||Regression, Logistic||||
1632648|NCT02059291|2999943|Superiority||Odds Ratio (OR)|16.96|||<|0.0001|2-Sided|95.0|4.15|69.21|||Regression, Logistic||||
1632649|NCT02059291|2999944|Superiority|||||||0.005|||||||Fisher's exact test||||
1632650|NCT02059291|2999944|Superiority|||||||0.002|||||||Fisher's exact test||||
1632651|NCT02059291|2999944|Superiority||||||<|0.0001|||||||Fisher's exact test||||
1632860|NCT02057757|3000269|Superiority|||||||0.5957||||||Fatigue|Fay-Shaw||||
1632652|NCT02059278|2999949|Equivalence|Analysis at 4 pm on Day 84|Mean Difference (Final Values)|0.456||||0.0649|2-Sided|95.0|-0.063|0.975|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.|
1632653|NCT02059278|2999949|Equivalence|Analysis at 10 am on Day 84|Mean Difference (Final Values)|0.627||||0.0113|2-Sided|95.0|0.143|1.111|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.|
1632654|NCT02059278|2999949|Equivalence|Analysis at 8 am on Day 84|Mean Difference (Final Values)|0.808||||0.0025|2-Sided|95.0|0.286|1.329|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 84|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.|
1632655|NCT02059278|2999949|Equivalence|Analysis at 4 pm on Day 42|Mean Difference (Final Values)|0.538||||0.0491|2-Sided|95.0|0.002|1.074|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.|
1632656|NCT02059278|2999949|Equivalence|Analysis at 10 am on Day 42|Mean Difference (Final Values)|0.505||||0.0558|2-Sided|95.0|-0.013|1.024|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.|
1632657|NCT02059278|2999949|Equivalence|Analysis at 8 am on Day 42|Mean Difference (Final Values)|0.478||||0.1008|2-Sided|95.0|-0.093|1.05|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 42|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.|
1632658|NCT02059278|2999949|Equivalence|Analysis at 4 pm on Day 15|Mean Difference (Final Values)|0.542||||0.0398|2-Sided|95.0|0.025|1.058|||ANCOVA||ANCOVA on change from baseline at 4 pm on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.|
1632659|NCT02059278|2999949|Equivalence|Analysis at 10 am on Day 15|Mean Difference (Final Values)|0.664||||0.0098|2-Sided|95.0|0.161|1.167|||ANCOVA||ANCOVA on change from baseline at 10 am on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.|
1632660|NCT02059278|2999949|Equivalence|Analysis at 8 am on Day 15|Mean Difference (Final Values)|0.781||||0.0091|2-Sided|95.0|0.195|1.366|||ANCOVA||ANCOVA on change from baseline at 8 am on Day 15|The primary endpoint was measured at 9 separate assessment times (3 time points over a 12 hour period on 3 separate days. The primary analysis was based on a comparison of the IOP change from baseline between the two arms at each assessment.The equivalence margin was tested using an analysis of covariance on change from baseline with pooled site and baseline as a factor. Equivalence was considered to be met if the 95% confidence intervals were within 1.5 mmHg at each of the 9 assessment points.|
1632661|NCT02059213|2999962|Superiority|||||||0.87|||||||Fisher Exact|Mid P-value||With 20 patients treated with ADT and 40 treated with ADT + palbociclib there is a 64.2% power to detect a 20% difference in proportions with a one-sided type I error of 0.10 using the mid p-value method of the Fisher’s exact test.|
1632662|NCT02059187|2999963|Superiority or Other||Adjusted difference in percent|-0.9|||||2-Sided|95.0|-8.3|6.5|||||Calculated via Miettinen and Nurminen method, stratified by prior insulin status.||
1632663|NCT02059187|2999964|Superiority or Other||Adjusted difference in percent|2.8|||||2-Sided|95.0|-6.1|11.6|||||Calculated via Miettinen and Nurminen method, stratified by prior insulin status.||
1632664|NCT02059187|2999965|Superiority or Other||Difference in LS Means|-3.4|||||2-Sided|95.0|-11.3|4.4|||||||
1632665|NCT02059187|2999966|Superiority or Other||Difference in LS means|3.5|||||2-Sided|95.0|-3.7|10.7|||||||
1632666|NCT02059187|2999967|Superiority or Other||Dofference in LS means|0.01|||||2-Sided|95.0|-0.02|0.05|||||||
1632667|NCT02059187|2999968|Superiority or Other||Difference in LS means|1.4|||||2-Sided|95.0|-2.2|4.9|||||||
1632668|NCT02059187|2999969|Superiority or Other||Difference in percent|6.8|||||2-Sided|95.0|-0.6|14.2|||||||
1632669|NCT02059187|2999970|Superiority or Other||Difference in percentage|0.0|||||2-Sided|95.0|-8.5|8.5|||||||
1632670|NCT02059187|2999972|Superiority or Other||Difference in percentage|5.7|||||2-Sided|95.0|-2.3|13.7|||||||
1632671|NCT02059187|2999973|Non-Inferiority or Equivalence|MK-1293 was to be considered non-inferior to Lantus in type 2 diabetes mellitus (T2DM) if the upper bound of the two-sided 95% confidence interval (CI) for the between-treatment difference (MK-1293 minus Lantus) in least-squares (LS) means was below 0.4% based on a cLDA model.|Difference in least squares means|0.03|||||2-Sided|95.0|-0.12|0.18|||||||
1632672|NCT02059174|2999974|Non-Inferiority or Equivalence|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|1.0|||||2-Sided|90.0|0.95|1.04|||||Ratio (MK-1293 / EU-Approved Lantus)||
1632673|NCT02059174|2999975|Non-Inferiority or Equivalence|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.92|||||2-Sided|90.0|0.86|0.97|||||Ratio (MK-1293 / EU-Approved Lantus)||
1632674|NCT02059174|2999976|Non-Inferiority or Equivalence|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.97|||||2-Sided|90.0|0.93|1.03|||||Ratio (MK-1293 / EU-Approved Lantus)||
1632675|NCT02059174|2999977|Non-Inferiority or Equivalence|Similarity criteria was 90% confidence interval for geometric mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Geometric Mean Ratio|0.97|||||2-Sided|90.0|0.91|1.02|||||Ratio (MK-1293 / EU-Approved Lantus)||
1632676|NCT02059174|2999978|Non-Inferiority or Equivalence|Similarity criteria calculated via Fieller’s Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.96|||||2-Sided|95.0|0.91|1.02|||||Ratio (MK-1293 / EU-Approved Lantus)||
1632677|NCT02059174|2999979|Non-Inferiority or Equivalence|Similarity criteria calculated via Fieller’s Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.99|||||2-Sided|95.0|0.92|1.06|||||Ratio (MK-1293 / EU-Approved Lantus)||
1632678|NCT02059174|2999980|Non-Inferiority or Equivalence|Similarity criteria calculated via Fieller’s Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.9|||||2-Sided|95.0|0.81|0.99|||||Ratio (MK-1293 / EU-Approved Lantus)||
1632679|NCT02059174|2999981|Non-Inferiority or Equivalence|Similarity criteria calculated via Fieller’s Theorem was 95% confidence interval for arithmetic mean ratio (MK-1293/EU-Lantus™) falls between 0.80-1.25|Ratio of Arithmetic Means|0.95|||||2-Sided|95.0|0.88|1.01|||||Ratio (MK-1293 / EU-Approved Lantus)||
1632680|NCT02059174|2999982|Non-Inferiority or Equivalence|A frailty model was used with effects for treatment, period and sequence and a random effect for participant. A value of 1.00 for the hazard ratio corresponds to no difference between treatments.|Hazard Ratio (HR)|1.07|||||2-Sided|95.0|0.72|1.59|||||ratio (MK-1293 / EU-Approved Lantus)|Because numerous participants did not achieve End of Action within the 30-hour clamp timeframe, the pre-specified hypothesis of similarity with regard to mean DOA could not be tested and a survival analysis approach was undertaken. The hazard rate is a measure of the instantaneous risk of reaching End of Action at time t given End of Action has not been met up until time t, with the hazard ratio being an estimate of the relative difference in hazard rates between treatments.|
1632681|NCT02059161|2999983|Superiority or Other||Difference in the Least Squares Means|-0.02|||||2-Sided|95.0|-0.04|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632682|NCT02059161|2999984|Superiority or Other||Difference in the Least Squares Means|-1.25|||||2-Sided|95.0|-3.34|0.83|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632683|NCT02059161|2999985|Superiority or Other||Difference in the Least Squares Means|-0.01|||||2-Sided|95.0|-0.03|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632684|NCT02059161|2999986|Superiority or Other||Difference in the Least Squares Means|-0.74|||||2-Sided|95.0|-2.52|1.04|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632685|NCT02059161|2999987|Superiority or Other||Difference in the Least Squares Means|-0.02||||||95.0|-0.04|0.01|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632686|NCT02059161|2999988|Superiority or Other||Difference in the Least Squares Means|-1.5|||||2-Sided|95.0|-3.69|0.69|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632687|NCT02059161|2999989|Superiority or Other||Difference in Least Means Squares|0.0|||||2-Sided|95.0|-0.02|0.02|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632688|NCT02059161|2999990|Superiority or Other||Difference in Least Means Squares|-0.42|||||2-Sided|95.0|-2.33|1.48|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632689|NCT02059161|2999991|Superiority or Other||Adjusted Difference (A1C < 6.5%)|-4.4|||||2-Sided|95.0|-11.5|2.8|||||Miettinen and Nurminen||
1632690|NCT02059161|2999991|Superiority or Other||Adjusted Difference (A1C < 7.0%)|0.2|||||2-Sided|95.0|-8.7|9.1|||||Miettinen and Nurminen||
1632691|NCT02059161|2999992|Superiority or Other||Adjusted Difference in %s (A1C <6.5%)|-1.1|||||2-Sided|95.0|-8.6|6.5|||||Miettinen and Nurminen, stratified by prior insulin status.||
1632692|NCT02059161|2999992|Superiority or Other||Adjusted Difference in %s (A1C < 7.0%)|-0.8|||||2-Sided|95.0|-9.7|8.1|||||Miettinen and Nurminen, stratified by prior insulin status.||
1632861|NCT02057757|3000269|Superiority|||||||0.4022||||||Sore Throat|Fay-Shaw||||
1632693|NCT02059161|2999993|Superiority or Other||Difference in the Least Squares Means|-8.1|||||2-Sided|95.0|-18.6|2.4|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632694|NCT02059161|2999994|Superiority or Other||Difference in the Least Squares Means|-0.4|||||2-Sided|95.0|-8.9|8.2|||||Longitudinal data analysis model including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632695|NCT02059161|2999996|Superiority or Other||Difference in the Least Squares Means|-5.4|||||2-Sided|95.0|-19.7|8.9|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632696|NCT02059161|2999997|Superiority or Other||Difference in the least squares means|-0.02|||||2-Sided|95.0|-0.05|0.02|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632697|NCT02059161|2999998|Superiority or Other||Difference in the least squares means|-1.77|||||2-Sided|95.0|-4.92|1.39|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632698|NCT02059161|3000000|Superiority or Other||Difference in Percentages|0.8|||||2-Sided|95.0|-12.8|14.3|||||Miettinen & Nurminen||
1632699|NCT02059161|3000001|Superiority or Other||Differences in Percentages|-2.1|||||2-Sided|95.0|-9.8|5.5|||||Miettinen & Nurminen||
1632700|NCT02059161|3000002|Superiority or Other||Difference in the Least Squares Means|9.6|||||2-Sided|95.0|-3.0|22.2|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632701|NCT02059161|3000003|Superiority or Other||Difference in the Least Squares Means|-0.02|||||2-Sided|95.0|-0.06|0.01|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632702|NCT02059161|3000004|Superiority or Other||Difference in the Least Squares Means|-1.77|||||2-Sided|95.0|-4.69|1.16|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632703|NCT02059161|3000005|Superiority or Other||Difference in the Least Squares Means|-0.02|||||2-Sided|95.0|-0.18|0.14|||||Longitudinal data analysis including terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632704|NCT02059161|3000008|Superiority or Other||Difference in Percentages|-3.0|||||2-Sided|95.0|-16.1|10.1|||||Miettinen & Nurminen||
1632705|NCT02059161|3000009|Superiority or Other||Difference in the Percentages|-3.9|||||2-Sided|95.0|-11.8|4.0|||||Miettinen & Nurminen||
1632706|NCT02059161|3000010|Non-Inferiority or Equivalence|The criterion for declaring non-inferiority was for the upper bound of the 95% CI to lie below 0.4%.|Difference in the Least Squares Means|0.04|||||2-Sided|95.0|-0.11|0.19|||||Longitudinal data analysis model included terms for treatment, time, prior insulin status (intermediate-acting, or long-acting insulin), and the interaction of time by treatment, and time by prior insulin status.||
1632707|NCT02059148|3000015|Superiority or Other||Median Difference (Final Values)|1.95||||0.0006|2-Sided|90.0|1.0|2.0|||Wilcoxon (Mann-Whitney)||||
1632708|NCT02059148|3000016|Superiority or Other||Ratio of Geometric LSMeans|1.14|||||2-Sided|90.0|1.05|1.23|||||||
1632709|NCT02059148|3000017|Superiority or Other||Ratio of Geometric LSMeans|1.24|||||2-Sided|90.0|1.11|1.38|||||||
1632710|NCT02058940|3000046|Other|||||||0.2|||||||Spearman's Correlation Coefficient||||
1632711|NCT02058628|3000096|Superiority or Other|||||||0.0004||||||Data is represented as per CTR.|Wilcoxon (Mann-Whitney)|DUAC versus SKINOREN with a nominal alpha level of 5%, without adjustment for multiple comparisons.|||
1632712|NCT02058563|3000128|Non-Inferiority or Equivalence|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV_MMR over COM_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.02|||||2-Sided|95.0|0.93|1.11|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 76.1 (LL=71.5;UL=81.0) and 74.6 (LL=70.2;UL=79.4) respectively.|Non-inferiority of INV_MMR vaccine to COM_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed|
1632713|NCT02058563|3000129|Non-Inferiority or Equivalence|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV_MMR over COM_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.05|||||2-Sided|95.0|0.96|1.16|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 113.5 (LL=106.0;UL=121.6) and 107.8 (LL=100.7;UL=115.4) respectively.|Non-inferiority of INV_MMR vaccine to COM_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed.|
1632756|NCT02058368|3000160|Superiority|||||||0.007||||||P-value for IPSS improvement >= 25 percent has been presented for Month 24|Mantel Haenszel||||
1632757|NCT02058368|3000160|Superiority|||||||0.047||||||P-value for IPSS improvement >= 2 units has been presented for Month 24|Mantel Haenszel||||
1632714|NCT02058563|3000130|Non-Inferiority or Equivalence|Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV_MMR over COM_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.|Adjusted GMC ratio|1.0|||||2-Sided|95.0|0.91|1.11|||||Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are respectively 432 and 435 and adjusted GMCs = 1790.2 (LL=1669.6;UL=1919.5) and 1781.5 (LL=1661.8;UL=1909.7) respectively|Non-inferiority of INV_MMR vaccine to COM_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed|
1632715|NCT02058498|3000138|Superiority or Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1632716|NCT02058368|3000145|Superiority|||||||0.28||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 24|Van Elteren test||||
1632717|NCT02058368|3000145|Superiority|||||||0.98||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 18|Van Elteren test||||
1632718|NCT02058368|3000145|Superiority|||||||0.84||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 12|Van Elteren test||||
1632719|NCT02058368|3000145|Superiority|||||||0.77||||||P-value for Dut+Tam vs. Tam is based on a van Elteren test with stratification by country for Month 6|Van Elteren test||||
1632720|NCT02058368|3000147|Superiority||Mean Difference (Final Values)|-2.7|Standard Error of the Mean|0.23|<|0.001|2-Sided|95.0|-3.1|-2.2||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.||
1632721|NCT02058368|3000147|Superiority||Mean Difference (Final Values)|-2.1|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|-2.3|-1.9||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.||
1632722|NCT02058368|3000147|Superiority||Mean Difference (Final Values)|-1.9|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|-2.1|-1.6||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.||
1632723|NCT02058368|3000152|Superiority||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.27||0.009|2-Sided|95.0|-1.23|-0.18||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.||
1632724|NCT02058368|3000152|Superiority||Mean Difference (Final Values)|-1.02|Standard Error of the Mean|0.26|<|0.001|2-Sided|95.0|-1.54|-0.5||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value.P-values for Dut+Tam versus Tam are based on t-tests from the general linear model for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam.||
1632725|NCT02058368|3000153|Superiority||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.21||0.034|2-Sided|95.0|-0.88|-0.03||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 24||
1632726|NCT02058368|3000153|Superiority||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.21||0.51|2-Sided|95.0|-0.56|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 21||
1632727|NCT02058368|3000153|Superiority||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.2||0.56|2-Sided|95.0|-0.52|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 18||
1632728|NCT02058368|3000153|Superiority||Median Difference (Final Values)|-0.11|Standard Error of the Mean|0.21||0.59|2-Sided|95.0|-0.51|0.29||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 15||
1632729|NCT02058368|3000153|Superiority||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.21||0.46|2-Sided|95.0|-0.25|0.55||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 12||
1632730|NCT02058368|3000153|Superiority||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.2||0.15|2-Sided|95.0|-0.1|0.68||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 9||
1632731|NCT02058368|3000153|Superiority||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.2||0.33|2-Sided|95.0|-0.2|0.59||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 6||
1632758|NCT02058368|3000160|Superiority|||||||0.016||||||P-value for IPSS improvement >= 3 units has been presented for Month 24|Mantel Haenszel||||
1632759|NCT02058368|3000160|Superiority|||||||0.084||||||P-value for IPSS improvement >= 25 percent has been presented for Month 21|Mantel Haenszel||||
1632732|NCT02058368|3000153|Superiority||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.18||0.17|2-Sided|95.0|-0.11|0.62||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut+Tam versus Tam are based on t-tests from the general linear model.|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam for Month 3||
1632733|NCT02058368|3000154|Superiority||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.11||0.16|2-Sided|95.0|-0.37|0.06||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam||
1632734|NCT02058368|3000154|Superiority||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.11||0.6|2-Sided|95.0|-0.16|0.28||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 21|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam||
1632735|NCT02058368|3000154|Superiority||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.11||0.44|2-Sided|95.0|-0.3|0.13||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam||
1632736|NCT02058368|3000154|Superiority||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.37|2-Sided|95.0|-0.3|0.11||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 15|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam||
1632737|NCT02058368|3000154|Superiority||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.1||0.8|2-Sided|95.0|-0.23|0.18||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam||
1632738|NCT02058368|3000154|Superiority||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.11||0.21|2-Sided|95.0|-0.07|0.34||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 9|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam||
1632739|NCT02058368|3000154|Superiority||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.1||0.11|2-Sided|95.0|-0.04|0.36||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam||
1632740|NCT02058368|3000154|Superiority||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.1||0.83|2-Sided|95.0|-0.17|0.21||Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Country + Baseline Value for Month 3|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam||
1632741|NCT02058368|3000155|Superiority||Cox Proportional Hazard|0.69||||0.68|2-Sided|95.0|0.11|4.11||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank||||
1632742|NCT02058368|3000156|Superiority||Cox Proportional Hazard|0.15||||0.005|2-Sided|95.0|0.03|0.68||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank||||
1632743|NCT02058368|3000157|Superiority||Cox Proportional Hazard|0.27||||0.012|2-Sided|95.0|0.09|0.81||Relative Risk (hazard ratio) for Dut+Tam vs. Tam is based on the Cox Proportional Hazards Model with stratification by country.|Log Rank||||
1632744|NCT02058368|3000158|Superiority||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 30 % for Month 24|Mantel Haenszel||||
1632745|NCT02058368|3000158|Superiority||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 3 mL/sec for Month 24|Mantel Haenszel||||
1632746|NCT02058368|3000158|Superiority||||||<|0.009||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 30 % for Month 18|Mantel Haenszel||||
1632747|NCT02058368|3000158|Superiority||||||<|0.002||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 3 mL/sec for Month 18|Mantel Haenszel||||
1632748|NCT02058368|3000158|Superiority||||||<|0.003||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 30 % for Month 12|Mantel Haenszel||||
1632749|NCT02058368|3000158|Superiority||||||<|0.001||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 3 mL/sec for Month 12|Mantel Haenszel||||
1632750|NCT02058368|3000158|Superiority||||||<|0.15||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 30 % for Month 6|Mantel Haenszel||||
1632751|NCT02058368|3000158|Superiority||||||<|0.13||||||P-value for Dut+Tam vs. Tam is based on a Mantel-Haenszel test controlling for country for >= 3 mL/sec for Month 6|Mantel Haenszel||||
1632752|NCT02058368|3000159|Superiority||Mean Difference (Final Values)|1.34|Standard Error of the Mean|0.41||0.001|2-Sided|95.0|0.54|2.15||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 24|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam||
1632753|NCT02058368|3000159|Superiority||Mean Difference (Final Values)|1.46|Standard Error of the Mean|0.42|<|0.001|2-Sided|95.0|0.63|2.29||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 18|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam||
1632754|NCT02058368|3000159|Superiority||Mean Difference (Final Values)|1.0|Standard Error of the Mean|0.35|<|0.005|2-Sided|95.0|0.3|1.69||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 12|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam||
1632755|NCT02058368|3000159|Superiority||Mean Difference (Final Values)|0.91|Standard Error of the Mean|0.33|<|0.006|2-Sided|95.0|0.26|1.56||Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Country + Baseline Value for Month 6|General linear model||The adjusted mean difference was based on Dut+Tam minus Tam||
1632851|NCT02057757|3000267|Superiority|||||||0.681||||||Any Time|Fay - Shaw||||
1632760|NCT02058368|3000160|Superiority|||||||0.42||||||P-value for IPSS improvement >= 2 units has been presented for Month 21|Mantel Haenszel||||
1632761|NCT02058368|3000160|Superiority|||||||0.39||||||P-value for IPSS improvement >= 3 units has been presented for Month 21|Mantel Haenszel||||
1632762|NCT02058368|3000160|Superiority|||||||0.28||||||P-value for IPSS improvement >= 25 percent has been presented for Month 18|Mantel Haenszel||||
1632763|NCT02058368|3000160|Superiority|||||||0.19||||||P-value for IPSS improvement >= 2 units has been presented for Month 18|Mantel Haenszel||||
1632764|NCT02058368|3000160|Superiority|||||||0.18||||||P-value for IPSS improvement >= 3 units has been presented for Month 18|Mantel Haenszel||||
1632765|NCT02058368|3000160|Superiority|||||||0.022||||||P-value for IPSS improvement >= 25 percent has been presented for Month 15|Mantel Haenszel||||
1632766|NCT02058368|3000160|Superiority|||||||0.11||||||P-value for IPSS improvement >= 2 units has been presented for Month 15|Mantel Haenszel||||
1632767|NCT02058368|3000160|Superiority|||||||0.17||||||P-value for IPSS improvement >= 3 units has been presented for Month 15|Mantel Haenszel||||
1632768|NCT02058368|3000160|Superiority|||||||0.048||||||P-value for IPSS improvement >= 25 percent has been presented for Month 12|Mantel Haenszel||||
1632769|NCT02058368|3000160|Superiority|||||||0.26||||||P-value for IPSS improvement >= 2 units has been presented for Month 12|Mantel Haenszel||||
1632770|NCT02058368|3000160|Superiority|||||||0.14||||||P-value for IPSS improvement >= 3 units has been presented for Month 12|Mantel Haenszel||||
1632771|NCT02058368|3000160|Superiority|||||||0.06||||||P-value for IPSS improvement >= 25 percent has been presented for Month 9|Mantel Haenszel||||
1632772|NCT02058368|3000160|Superiority|||||||0.42||||||P-value for IPSS improvement >= 2 units has been presented for Month 9|Mantel Haenszel||||
1632773|NCT02058368|3000160|Superiority|||||||0.08||||||P-value for IPSS improvement >= 3 units has been presented for Month 9|Mantel Haenszel||||
1632774|NCT02058368|3000160|Superiority|||||||0.81||||||P-value for IPSS improvement >= 25 percent has been presented for Month 6|Mantel Haenszel||||
1632775|NCT02058368|3000160|Superiority|||||||0.89||||||P-value for IPSS improvement >= 2 units has been presented for Month 6|Mantel Haenszel||||
1632776|NCT02058368|3000160|Superiority|||||||0.92||||||P-value for IPSS improvement >= 3 units has been presented for Month 6|Mantel Haenszel||||
1632777|NCT02058368|3000160|Superiority|||||||0.42||||||P-value for IPSS improvement >= 25 percent has been presented for Month 3|Mantel Haenszel||||
1632778|NCT02058368|3000160|Superiority|||||||0.31||||||P-value for IPSS improvement >= 2 units has been presented for Month 3|Mantel Haenszel||||
1632779|NCT02058368|3000160|Superiority|||||||0.91||||||P-value for IPSS improvement >= 3 units has been presented for Month 3|Mantel Haenszel||||
1632780|NCT02058368|3000161|Superiority|Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.|Mean Difference (Final Values)|-28.4|Standard Error of the Mean|1.65|<|0.001|2-Sided|95.0|-31.7|-25.2|||General linear model||The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 24||
1632781|NCT02058368|3000161|Superiority||Mean Difference (Final Values)|-23.0|Standard Error of the Mean|1.48|<|0.001|2-Sided|95.0|-25.9|-20.1||Estimates are based on the adjusted means from the general linear model: Log(Post-Baseline Prostate Volume / Baseline Prostate Volume) = Log(Baseline Prostate Volume) + Treatment + Country. P-values are based on t-tests from the general linear model.|General linear model||The adjusted mean estimates, adjusted mean differences, and confidence intervals are expressed in terms of percentage change from Baseline for Month 12.||
1632782|NCT02058368|3000162|Superiority||Mean Difference (Final Values)|-1.43||||0.004|2-Sided|95.0|-2.4|-0.46||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 24.||
1632783|NCT02058368|3000162|Superiority||Mean Difference (Final Values)|-0.72||||0.15|2-Sided|95.0|-1.68|0.25||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 21.||
1632784|NCT02058368|3000162|Superiority||Mean Difference (Final Values)|-0.7||||0.15|2-Sided|95.0|-1.65|0.26||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 18.||
1632785|NCT02058368|3000162|Superiority||Mean Difference (Final Values)|-0.95||||0.039|2-Sided|95.0|-1.85|-0.05||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg+Tam 0.2 mg versus Placebo+ Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 15.||
1632786|NCT02058368|3000162|Superiority||Mean Difference (Final Values)|-0.37||||0.41|2-Sided|95.0|-1.27|0.53||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 12.||
1632852|NCT02057757|3000268|Superiority|||||||0.985|||||||Fay - Shaw||||
1632853|NCT02057757|3000269|Superiority|||||||0.6986||||||Diarrhea|Fay-Shaw||||
1632854|NCT02057757|3000269|Superiority|||||||0.5176||||||Vomiting|Fay-Shaw||||
1632855|NCT02057757|3000269|Superiority|||||||0.2155||||||Nausea|Fay-Shaw||||
1632787|NCT02058368|3000162|Superiority||Mean Difference (Final Values)|-0.14||||0.76|2-Sided|95.0|-1.05|0.77||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 9.||
1632788|NCT02058368|3000162|Superiority||Mean Difference (Final Values)|0.37||||0.43|2-Sided|95.0|-0.55|1.29||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2 mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 6.||
1632789|NCT02058368|3000162|Superiority||Mean Difference (Final Values)|0.79||||0.069|2-Sided|95.0|-0.06|1.65||Change from Baseline = Treatment + Country + Baseline Value. P-values for Dut 0.5 mg + Tam 0.2 mg versus Placebo + Tam 0.2mg are based on t-tests from the general linear model. Reported means are model based adjusted means.|General linear model||Estimates are based on adjusted means from the general linear model. The adjusted mean difference was based on combination minus tamsulosin monotherapy for Month 3.||
1632790|NCT02058290|3000165|Superiority or Other|||||||0.0019|||||||Log Rank||||
1632791|NCT02058290|3000166|Superiority or Other|||||||0.2612|||||||ANOVA||||
1632792|NCT02058290|3000167|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1632793|NCT02058160|3000178|Superiority or Other||LS Mean Difference|-0.26|Standard Error of the Mean|0.766||0.7362|2-Sided|95.0|-1.762|1.246||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline daily insulin glargine dose-by-visit interaction as a covariate.|
1632794|NCT02058160|3000179|Superiority or Other||difference in percentage|20.82|||<|0.0001|2-Sided|95.0|14.98|26.66||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (<8.0%, ≥8.0%) and randomization strata of metformin use at screening.|
1632795|NCT02058160|3000180|Superiority or Other||LS Mean Difference|-0.9|Standard Error of the Mean|0.131|<|0.0001|2-Sided|95.0|-1.154|-0.64||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline average SMPG value-by-visit interaction as covariates.|
1632796|NCT02058160|3000181|Superiority or Other||LS Mean Difference|-1.37|Standard Error of the Mean|0.224|<|0.0001|2-Sided|95.0|-1.808|-0.93||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of metformin use at screening, scheduled visits, treatment-by-visit interaction and country as fixed effects and baseline body weight value-by-visit interaction as covariates.|
1632797|NCT02058160|3000182|Superiority or Other||LS Mean Difference|-3.43|Standard Error of the Mean|0.251|<|0.0001|2-Sided|95.0|-3.925|-2.939||Threshold for significance at 0.05 level.|ANCOVA||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of metformin use at screening and country as fixed effects and baseline 2-hour plasma glucose excursion value as a covariate.|
1632798|NCT02058160|3000183|Superiority or Other||Difference in percentage|19.76|||<|0.0001|2-Sided|95.0|13.9|25.62|||Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order."|
1632799|NCT02058160|3000183|Superiority or Other||Difference in percentage|25.52|||<|0.0001|2-Sided|95.0|18.94|32.1||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||HbA1c <7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|"HbA1c <7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin Glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (<8.0%, ≥8.0%) and randomization strata of metformin use at screening. This analysis was out of testing order."|
1632800|NCT02058160|3000184|Superiority or Other||Least square (LS) mean difference|-0.52|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.633|-0.397||Threshold for significance at 0.05 level.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of metformin use at screening, visits, treatment-by-visit interaction and country as fixed effects and baseline HbA1c value-by-visit interaction as covariates. A hierarchical testing procedure was used to control type I error and handle multiple endpoint analyses.|
1632801|NCT02058147|3000191|Superiority or Other||LS Mean Difference|-0.69|Standard Error of the Mean|0.99||0.4857|2-Sided|95.0|-2.632|1.252||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects.|
1632802|NCT02058147|3000192|Superiority or Other||Difference in percentage|12.98|||<|0.0001|2-Sided|95.0|7.5|18.45||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (<8.0%, ≥8.0%) and randomization strata of second OAD use at screening.|
1632803|NCT02058147|3000193|Superiority or Other||Difference in percentage|18.08|||<|0.0001|2-Sided|95.0|12.15|24.01||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (<8%, ≥8%) and randomization strata of second OAD use at screening.|
1632804|NCT02058147|3000194|Superiority or Other||LS Mean Difference|-0.69|Standard Error of the Mean|0.101|<|0.0001|2-Sided|95.0|-0.892|-0.495||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin Glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline 7-point SMPG value-by-visit interaction, as a covariate.|
1632805|NCT02058147|3000194|Superiority or Other||LS Mean Difference|-1.4|Standard Error of the Mean|0.124|<|0.0001|2-Sided|95.0|-1.645|-1.158||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline 7-point SMPG value-by-visit interaction as a covariate.|
1632806|NCT02058147|3000195|Superiority or Other||LS Mean Difference|-1.96|Standard Error of the Mean|0.144|<|0.0001|2-Sided|95.0|-2.246|-1.682||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline FPG value-by-visit interaction as a covariate.|
1632807|NCT02058147|3000196|Superiority or Other||LS Mean Difference|-1.4|Standard Error of the Mean|0.25|<|0.0001|2-Sided|95.0|-1.891|-0.91||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the hierarchical testing procedure (continued only if previous endpoints were statistically significant). Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline body weight value-by-visit interaction as a covariate.|
1632808|NCT02058147|3000197|Superiority or Other||LS Mean Difference|-2.13|Standard Error of the Mean|0.185|<|0.0001|2-Sided|95.0|-2.498|-1.77||Threshold for significance ≤0.05. The hierarchical testing continued only when primary hypotheses (superiority: FRC to lixisenatide; non-inferiority: FRC to insulin glargine for HbA1c) was statistically significant.|ANCOVA||Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (<8.0,≥8.0%), randomization strata of second OAD use at screening & country as fixed effects & baseline plasma glucose excursion value as a covariate. Hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially per pre-specified order.|
1632809|NCT02058147|3000198|Superiority or Other||Difference in percentage|16.35|||<|0.0001|2-Sided|95.0|10.13|22.58||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."|
1632810|NCT02058147|3000198|Superiority or Other||Difference in percentage|14.31|||<|0.0001|2-Sided|95.0|8.37|20.25||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c <7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.|"HbA1c <7.0%: Insulin Glargine/Lixisenatide FRC vs Insulin glargine.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."|
1632811|NCT02058147|3000198|Superiority or Other||Difference in percentage|36.38|||<|0.0001|2-Sided|95.0|29.81|42.95||Threshold for significance ≤ 0.05.|Cochran-Mantel-Haenszel||HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.|"HbA1c ≤6.5%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."|
1632812|NCT02058147|3000198|Superiority or Other||Difference in percentage|40.61|||<|0.0001|2-Sided|95.0|33.63|47.59||Threshold for significance ≤0.05.|Cochran-Mantel-Haenszel||HbA1c <7.0%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.|"HbA1c <7.0%: Insulin Glargine/Lixisenatide FRC vs Lixisenatide.~Analysis was performed using Cochran-Mantel-Haenszel method stratified on randomization strata of Week -1 HbA1c (<8.0%, ≥8.0%) and randomization strata of second OAD use at screening. This analysis was out of testing order."|
1632813|NCT02058147|3000199|Superiority or Other||LS Mean Difference|-0.29|Standard Error of the Mean|0.048|<|0.0001|2-Sided|95.0|-0.384|-0.194||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Test of superiority was also performed as a secondary endpoint according to hierarchical testing procedure. Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction, as a covariate.|
1632856|NCT02057757|3000269|Superiority|||||||0.1234||||||Muscle Pain|Fay-Shaw||||
1632814|NCT02058147|3000199|Non-Inferiority or Equivalence|Predefined non-inferiority margin of 0.3%.|LS Mean Difference|-0.29|Standard Error of the Mean|0.048|<||2-Sided|95.0|-0.384|-0.194|||||Insulin Glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using MMRM model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction as a covariate.|
1632815|NCT02058147|3000199|Superiority or Other||Least Square (LS) Mean Difference|-0.78|Standard Error of the Mean|0.059|<|0.0001|2-Sided|95.0|-0.898|-0.665||Threshold for significance ≤0.05.|Mixed Models Analysis||Insulin Glargine/Lixisenatide FRC vs Lixisenatide|Analysis was performed using Mixed-effect model with repeated measures (MMRM) with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of second OAD use at screening, visits, treatment-by-visit interaction, and country as fixed effects and baseline HbA1c value-by-visit interaction as a covariate.|
1632816|NCT02058108|3000201|Other||Mean Difference (Net)|2.5||||1|2-Sided|95.0|-37.05|41.83|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|Treatment emergent genotypic resistance at Week 24|
1632817|NCT02058108|3000204|Other||Mean Difference (Net)|2.44||||1|2-Sided|95.0|-37.54|42.17|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBsAg loss at Week 24|
1632818|NCT02058108|3000205|Other||Mean Difference (Net)|2.7||||1|2-Sided|95.0|-53.7|60.2|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBeAg seroconversion at Week 24|
1632819|NCT02058108|3000205|Other||Mean Difference (Net)|2.7||||1|2-Sided|95.0|-53.7|60.2|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|HBeAg loss at Week 24|
1632820|NCT02058108|3000206|Other||Mean Difference (Net)|32.43||||0.2984|2-Sided|95.0|-14.62|74.6|||Fisher Exact||Exact confidence interval for the difference in percentage. P-value from Fishers exact test comparing proportions in Initial LdT and Initial Placebo groups.|ALT levels at Week 24|
1632821|NCT02058108|3000208|Other|Missing assessment imputed using the closest available assessment|Mean Difference (Net)|-0.3||||1|2-Sided|95.0|-37.03|36.75|||Fisher Exact|||HBV DNA level of <300 copies/mL (51 IU/mL) at Week 24|Exact confidence interval for the difference in percentage
1632822|NCT02058095|3000209|Superiority|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1632823|NCT02058095|3000211|Superiority|||||||0.04|||||||Wilcoxon (Mann-Whitney)||||
1632824|NCT02058069|3000212|Non-Inferiority|The upper bound for the one-sided 95% confidence interval will be compared with -9. If the upper bound is less than -9, then non-inferiority holds.|Mean Difference (Final Values)|-33.1|||<|0.001|1-Sided|95.0||-29.6|||t-test, 2 sided||If the upper bound is less than -9, then non-inferiority holds.|Change from pre-op to 3 months|
1632825|NCT02058069|3000213|Other|The analysis was performed using standard OC curves generated using Sample Size Analyzer® version 2.0 by Taylor Enterprise Inc. (Dr. Wayne A. Taylor).|Alignment Difference <4.38 Degrees|1.0|||||1-Sided|95.0|0.966||||||Estimation Parameter is: proportion of participants with limb alignment difference <4.38 degrees If the lower bound is >0.95 then the assessment passes.||
1632826|NCT02058069|3000215|Non-Inferiority or Equivalence|The Alternative Hypothesis: The Investigational Device (RIO) true event rate is non-inferior to 0.066 (event rate for manual TKA) with a non-inferiority margin of 0.06. The 0.066 rate is based on literature and 0.06 was determined in consultation with FDA.|Rare Adverse Event Rate|0.0|||||1-Sided|95.0||0.0331|||||If the upper bound is <0.126 then the primary composite safety endpoint is met. After the surgeon completed the procedure, at the conclusion of the participant’s hospital stay, and 3 months post-operative were used in this single analysis.||
1632827|NCT02057757|3000259|Superiority|||||||0.9785||||||No Detectable Virus on Day 3|Fay-Shaw||||
1632828|NCT02057757|3000263|Superiority|||||||0.9231||||||Children (<18 Years) - Global Assessment: Are you/your child functioning as well as you/your child were before you/your child had the respiratory illness?|Fay-Shaw||||
1632829|NCT02057757|3000263|Superiority|||||||0.5035||||||Children (< 18 Years) - Global Assessment: Have you/your child felt as good as you did before you had the respiratory illness?|Fay-Shaw||||
1632830|NCT02057757|3000263|Superiority|||||||0.038||||||Adults (>= 18 Years) - Global Assessment: Are you functioning as well as you were before you had the respiratory illness?|Fay-Shaw||||
1632831|NCT02057757|3000263|Superiority|||||||0.036||||||Adults (>= 18 Years ) - Global Assessment: Have you felt as good as you did before you had the respiratory illness?|Fay - Shaw||||
1632832|NCT02057757|3000264|Superiority|||||||0.0832||||||Bronchitis|Fay-Shaw||||
1632833|NCT02057757|3000264|Superiority|||||||0.9669||||||ARDS|Fay-Shaw||||
1632834|NCT02057757|3000264|Superiority|||||||0.928||||||Pneumonia|Fay - Shaw||||
1632835|NCT02057757|3000265|Superiority|||||||0.987||||||Day 28|Fay-Shaw||||
1632836|NCT02057757|3000265|Superiority|||||||0.987||||||Day 14|Fay-Shaw||||
1632837|NCT02057757|3000265|Superiority|||||||0.987||||||Day 7|Fay-Shaw||||
1632838|NCT02057757|3000265|Superiority|||||||0.548||||||Day 3|Fay-Shaw||||
1632839|NCT02057757|3000265|Superiority|||||||0.575||||||Day 0|Fay-Shaw||||
1632840|NCT02057757|3000265|Superiority|||||||0.973||||||Any Time|Fay - Shaw||||
1632841|NCT02057757|3000266|Superiority|||||||0.311||||||Day 14|Fay-Shaw||||
1632842|NCT02057757|3000266|Superiority|||||||0.987||||||Day 7|Fay-Shaw||||
1632843|NCT02057757|3000266|Superiority|||||||0.987||||||Day 3|Fay-Shaw||||
1632844|NCT02057757|3000266|Superiority|||||||0.325||||||Day 0|Fay-Shaw||||
1632845|NCT02057757|3000266|Superiority|||||||0.671||||||Any Time|Fay - Shaw||||
1632846|NCT02057757|3000267|Superiority|||||||0.544||||||Day 28|Fay-Shaw||||
1632847|NCT02057757|3000267|Superiority|||||||0.788||||||Day 14|Fay-Shaw||||
1632848|NCT02057757|3000267|Superiority|||||||0.957||||||Day 7|Fay-Shaw||||
1632849|NCT02057757|3000267|Superiority|||||||0.321||||||Day 3|Fay-Shaw||||
1632850|NCT02057757|3000267|Superiority|||||||0.341||||||Day 0|Fay-Shaw||||
1632862|NCT02057757|3000269|Superiority|||||||0.4277||||||Cough|Fay - Shaw||||
1632863|NCT02057757|3000271|Superiority|||||||0.671||||||Day 28|Fay-Shaw||||
1632864|NCT02057757|3000271|Superiority|||||||0.809||||||Day 14|Fay-Shaw||||
1632865|NCT02057757|3000271|Superiority|||||||0.989||||||The p-value for each value was calculated (Day 7).|Fay-Shaw||||
1632866|NCT02057757|3000271|Superiority|||||||0.645||||||The p-value for each time point was calculated; Day 3|Fay - Shaw||||
1632867|NCT02057757|3000272|Equivalence|The equivalence margin is 1.25 Days.||||||0.5634|||||||Fay - Shaw||||
1632868|NCT02057692|3000277|Superiority||LS mean difference|-0.039|Standard Error of the Mean|0.4431||0.9298|2-Sided|95.0|-0.942|0.863|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by ANCOVA using a PROC MIXED procedure. LS mean change from baseline to Endpoint (Week 13/ET), along with associated 95% confidence interval (CI) for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.|
1632869|NCT02057692|3000277|Superiority||LS mean difference|-0.906|Standard Error of the Mean|0.3503||0.0145|2-Sided|95.0|-1.62|-0.192|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by ANCOVA using a PROC MIXED procedure. LS mean change from baseline to Endpoint (Week 13/ET), along with associated 95% CI for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.|
1632870|NCT02057692|3000277|Superiority||LS mean difference|-0.889|Standard Error of the Mean|0.3969||0.0321|2-Sided|95.0|-1.698|0.081|||ANCOVA|||The primary analysis of change from baseline to endpoint (Week 13/ET) average daily ItchRO(Obs) was evaluated by analysis of covariance (ANCOVA) using a PROC MIXED procedure. Least-squares (LS) mean change from baseline to Endpoint (Week 13/ET), along with associated 95% confidence interval (CI) for the LS mean, and pair-wise treatment P-values were calculated for each treatment group.|
1632871|NCT02057575|3000282|Superiority||||||<|0.0001|||||||t-test, 2 sided|PG324 0.02% vs. latanoprost|||
1632872|NCT02057575|3000282|Superiority||||||<|0.0001|||||||t-test, 2 sided|PG324 0.01% vs. latanoprost|||
1632873|NCT02057575|3000282|Superiority||||||<|0.0001||||||PG324 0.02% vs. netarsudil|t-test, 2 sided||||
1632874|NCT02057575|3000282|Superiority||||||<|0.0001||||||PG324 0.01% vs netarsudil|t-test, 2 sided||||
1632875|NCT02057406|3000301|Superiority|2:1 EPA/DHA versus High EPA at Week 12.||||||0.12|||||||ANCOVA|||The model used post-treatment EPA values as the dependent variable and included age, race, sex, treatment site, and the baseline EPA value as covariates. This analyses was conducted under intention-to-treat (ITT) in which the missing EPA endpoint values were imputed using 50 imputations.|
1632876|NCT02057406|3000301|Superiority|Active supplements (2:1 EPA/DHA and High EPA combined) versus placebo at Week 12.|||||<|0.0001|||||||ANCOVA|||The model used post-treatment EPA values as the dependent variable and included age, race, sex, treatment site, and the baseline EPA value as covariates. This analyses was conducted under intention-to-treat (ITT) in which the missing EPA endpoint values were imputed using 50 imputations.|
1632877|NCT02057406|3000302|Superiority|High EPA group versus placebo group at Week 12.||||||0.45|||||||ANCOVA|||The model used post-treatment HAMD values as the dependent variable and included age, race, sex, treatment site, and the baseline HAMD value as covariates. This analysis was conducted under intention-to-treat (ITT) in which the missing HAMD endpoint values were imputed using 50 imputations.|
1632878|NCT02057406|3000302|Superiority|The EPA/DHA arm versus placebo at Week 12.||||||0.74|||||||ANCOVA|||The model used post-treatment HAMD values as the dependent variable and included age, race, sex, treatment site, and the baseline HAMD value as covariates. This analysis was conducted under intention-to-treat (ITT) in which the missing HAMD endpoint values were imputed using 50 imputations.|
1632879|NCT02057198|3000311|Superiority|||||||0.66|||||||Chi square (two proportion test)||||
1632880|NCT02057198|3000311|Superiority|||||||0.48|||||||Chi square (two proportion test)||||
1632881|NCT02057198|3000313|Superiority||Slope|-0.85||||0.002|2-Sided|95.0|-1.14|-0.57|||Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|
1632882|NCT02057198|3000313|Superiority||Slope|-0.43||||0.05|2-Sided|95.0|-0.67|-0.19|||Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|
1632883|NCT02057198|3000314|Superiority|||||||0.52|||||||Chi square (2 proportion test)||||
1632884|NCT02057198|3000314|Superiority|||||||0.99|||||||Chi square (2 proportion test)||||
1632885|NCT02057198|3000315|Superiority|||||||0.01|||||||Chi square (2 proportion test)||||
1632886|NCT02057198|3000315|Superiority||||||<|0.001|||||||Chi square (2 proportion test)||||
1632887|NCT02057198|3000316|Superiority||Slope|-0.17||||0.66|2-Sided|95.0|-0.69|0.35||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group|||
1632888|NCT02057198|3000316|Superiority||Slope|-0.15||||0.52|2-Sided|95.0|-0.34|0.05||Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|Mixed Models Analysis|A mixed effects model was used to compare decay slopes for the reduction in log(CFUs)/day according to each treatment group|||
1632889|NCT02057068|3000317|Superiority||||||<|0.05|||||||ANOVA||||
1632890|NCT02057068|3000318|Superiority|Intention to treat analysis with last observation carried forward|||||>|0.05|||||||ANOVA||||
1632891|NCT02057068|3000319|Superiority||||||<|0.001|||||||ANOVA|Intention to treat analysis with last observation carried forward|||Partial Eta Squared = .282
1632892|NCT02057042|3000320|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1632893|NCT02057042|3000321|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1632894|NCT02057042|3000322|Superiority||||||<|0.05|||||||Mixed Models Analysis||||
1632895|NCT02057042|3000323|Superiority||||||<|0.05|||||||Mixed Models Analysis||||
1632896|NCT02057042|3000324|Superiority||||||<|0.05|||||||Mixed Models Analysis||||
1632897|NCT02057042|3000325|Superiority||||||<|0.05|||||||Mixed Models Analysis||||
1632898|NCT02056834|3000328|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the change from baseline within treatment group.|
1632899|NCT02056834|3000329|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the change from baseline within treatment group.|
1632900|NCT02056834|3000330|Superiority or Other|||||||0.3785|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.|
1632901|NCT02056834|3000331|Superiority or Other|||||||0.0166|||||||t-test, 2 sided|||Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.|
1632902|NCT02056392|3000358|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|4.0|||||2-Sided|90.0|2.4|5.7||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632903|NCT02056392|3000358|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-2.5|||||2-Sided|90.0|-4.1|-0.9||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632904|NCT02056392|3000359|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|7.6|||||2-Sided|90.0|6.0|9.3||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632905|NCT02056392|3000359|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-4.7|||||2-Sided|90.0|-6.4|-3.1||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632906|NCT02056392|3000360|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|8.9|||||2-Sided|90.0|7.2|10.5||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632907|NCT02056392|3000360|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.3|||||2-Sided|90.0|-2.9|0.4||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632908|NCT02056392|3000361|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|8.8|||||2-Sided|90.0|7.1|10.4||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632909|NCT02056392|3000361|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.8|||||2-Sided|90.0|-3.4|-0.1||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632910|NCT02056392|3000362|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|10.8|||||2-Sided|90.0|9.2|12.5||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632911|NCT02056392|3000362|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-1.5|||||2-Sided|90.0|-3.1|0.2||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632912|NCT02056392|3000363|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|11.9||||||90.0|10.3|13.6||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1633236|NCT02054702|3000521|Superiority or Other|||||||0.7623|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for aripiprazole.|
1632913|NCT02056392|3000363|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.2|||||2-Sided|90.0|-1.8|1.5||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632914|NCT02056392|3000364|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|10.1|||||2-Sided|90.0|8.5|11.8||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632915|NCT02056392|3000364|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|0.4|||||2-Sided|90.0|-1.2|2.0||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632916|NCT02056392|3000365|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|9.9|||||2-Sided|90.0|8.3|11.5||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632917|NCT02056392|3000365|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|0.9|||||2-Sided|90.0|-0.7|2.5||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632918|NCT02056392|3000366|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|9.2|||||2-Sided|90.0|7.6|10.8||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632919|NCT02056392|3000366|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.4|||||2-Sided|90.0|-2.0|1.3||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632920|NCT02056392|3000367|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|6.1|||||2-Sided|90.0|4.4|7.7||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632921|NCT02056392|3000367|Non-Inferiority or Equivalence|All one-sided 95% confidence intervals at each time point for the selumetinib difference versus placebo (2-sided 90% CIs) should be less than 10ms.|Mean Difference (Final Values)|-0.2|||||2-Sided|90.0|-1.8|1.5||||||47 evaluable volunteers gives 90% power to show non-inferiority of selumetinib versus placebo across all 10 post-dose time points, using paired T-test, 1-sided alpha=0.05 and assuming a true difference of 3 msec.|
1632922|NCT02056340|3000372|Other|||||||0.029||||||P value reflects baseline to 72 hours between groups. A p-value <0.05 will be considered significant.|Mixed Models Analysis|||The primary comparison was at 72 hours for the self-reported influenza severity score.|
1632923|NCT02056340|3000373|Other|||||||0.611||||||Threshold for significaance was p value <0.05.|Mixed Models Analysis|||We used a linear mixed-effects model which accounted for all measurements taken and the time that those measurements were taken.|
1632924|NCT02055976|3000388|Superiority or Other||Adjusted Mean Difference|-64.67274|Standard Error of the Mean|4.06866|<|0.001|2-Sided|95.0|-72.75728|-56.5882|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632925|NCT02055976|3000388|Superiority or Other||Adjusted Mean Difference|-61.3789|Standard Error of the Mean|4.09957|<|0.001|2-Sided|95.0|-69.52338|-53.23443|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632926|NCT02055976|3000388|Superiority or Other||Adjusted Mean Difference|-46.34109|Standard Error of the Mean|4.16385|<|0.001|2-Sided|95.0|-54.61427|-38.06792|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632927|NCT02055976|3000388|Superiority or Other||Adjusted Mean Difference|-61.5637|Standard Error of the Mean|3.7569|<|0.001|2-Sided|95.0|-69.0251|-54.1023|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632928|NCT02055976|3000388|Superiority or Other||Adjusted Mean Difference|-56.14495|Standard Error of the Mean|3.71641|<|0.001|2-Sided|95.0|-63.52668|-48.76322|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633779|NCT02038881|3001869|Other||Diff in SC rate (Gr 1 - Gr 2) at Week 56|-6.1|||||2-Sided|95.0|-35.6|23.7|||||||
1632929|NCT02055976|3000388|Superiority or Other||Adjusted Mean Difference|-40.52435|Standard Error of the Mean|3.66973|<|0.001|2-Sided|95.0|-47.81299|-33.23571|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632930|NCT02055976|3000388|Superiority or Other||Adjusted Mean Difference|-65.06617|Standard Error of the Mean|3.82052|<|0.001|2-Sided|95.0|-72.65818|-57.47415|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632931|NCT02055976|3000388|Superiority or Other||Adjusted Mean Difference|-62.34926|Standard Error of the Mean|3.86432|<|0.001|2-Sided|95.0|-70.02607|-54.67245|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632932|NCT02055976|3000388|Superiority or Other||Adjusted Mean Difference|-43.56596|Standard Error of the Mean|3.92236|<|0.001|2-Sided|95.0|-51.35899|-35.77293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632933|NCT02055976|3000388|Superiority or Other||Adjusted Mean Difference|-71.72901|Standard Error of the Mean|3.81541|<|0.001|2-Sided|95.0|-79.30431|-64.15371|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632934|NCT02055976|3000388|Superiority or Other||Adjusted Mean Difference|-66.63383|Standard Error of the Mean|3.7905|<|0.001|2-Sided|95.0|-74.16086|-59.10681|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632935|NCT02055976|3000388|Superiority or Other||Adjusted Mean Difference|-49.42411|Standard Error of the Mean|3.72907|<|0.001|2-Sided|95.0|-56.83019|-42.01803|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632936|NCT02055976|3000389|Superiority or Other||Adjusted Mean Difference|-0.45501|Standard Error of the Mean|0.02912|<|0.001|2-Sided|95.0|-0.51287|-0.39715|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632937|NCT02055976|3000389|Superiority or Other||Adjusted Mean Difference|-0.42583|Standard Error of the Mean|0.02932|<|0.001|2-Sided|95.0|-0.48409|-0.36758|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632938|NCT02055976|3000389|Superiority or Other||Adjusted Mean Difference|-0.31806|Standard Error of the Mean|0.02979|<|0.001|2-Sided|95.0|-0.37723|-0.25888|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632939|NCT02055976|3000389|Superiority or Other||Adjusted Mean Difference|-0.41199|Standard Error of the Mean|0.02676|<|0.001|2-Sided|95.0|-0.46512|-0.35886|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632940|NCT02055976|3000389|Superiority or Other||Adjusted Mean Difference|-0.37493|Standard Error of the Mean|0.02649|<|0.001|2-Sided|95.0|-0.42754|-0.32231|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632941|NCT02055976|3000389|Superiority or Other||Adjusted Mean Difference|-0.26949|Standard Error of the Mean|0.02615|<|0.001|2-Sided|95.0|-0.32142|-0.21755|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632942|NCT02055976|3000389|Superiority or Other||Adjusted Mean Difference|-0.46235|Standard Error of the Mean|0.03148|<|0.001|2-Sided|95.0|-0.52491|-0.3998|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632943|NCT02055976|3000389|Superiority or Other||Adjusted Mean Difference|-0.44143|Standard Error of the Mean|0.03183|<|0.001|2-Sided|95.0|-0.50466|-0.37821|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633237|NCT02054702|3000521|Superiority or Other|||||||0.4244|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test composite battery score from baseline to week 6 for brexpiprazole.|
1632944|NCT02055976|3000389|Superiority or Other||Adjusted Mean Difference|-0.30542|Standard Error of the Mean|0.0323|<|0.001|2-Sided|95.0|-0.3696|-0.24124|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632945|NCT02055976|3000389|Superiority or Other||Adjusted Mean Difference|-0.48314|Standard Error of the Mean|0.02698|<|0.001|2-Sided|95.0|-0.53671|-0.42956|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632946|NCT02055976|3000389|Superiority or Other||Adjusted Mean Difference|-0.44402|Standard Error of the Mean|0.02682|<|0.001|2-Sided|95.0|-0.49727|-0.39077|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632947|NCT02055976|3000389|Superiority or Other||Adjusted Mean Difference|-0.33157|Standard Error of the Mean|0.02639|<|0.001|2-Sided|95.0|-0.38399|-0.27916|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632948|NCT02055976|3000391|Superiority or Other||Adjusted Mean Difference|-51.87214|Standard Error of the Mean|3.09363|<|0.001|2-Sided|95.0|-58.01968|-45.7246|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632949|NCT02055976|3000391|Superiority or Other||Adjusted Mean Difference|-48.57807|Standard Error of the Mean|3.1135|<|0.001|2-Sided|95.0|-54.76397|-42.39217|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632950|NCT02055976|3000391|Superiority or Other||Adjusted Mean Difference|-38.06019|Standard Error of the Mean|3.1361|<|0.001|2-Sided|95.0|-44.29176|-31.82863|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632951|NCT02055976|3000391|Superiority or Other||Adjusted Mean Difference|-46.36865|Standard Error of the Mean|3.03981|<|0.001|2-Sided|95.0|-52.40589|-40.33142|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632952|NCT02055976|3000391|Superiority or Other||Adjusted Mean Difference|-43.8568|Standard Error of the Mean|3.00531|<|0.001|2-Sided|95.0|-49.82617|-37.88744|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632953|NCT02055976|3000391|Superiority or Other||Adjusted Mean Difference|-33.5292|Standard Error of the Mean|2.96599|<|0.001|2-Sided|95.0|-39.42015|-27.63826|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632954|NCT02055976|3000391|Superiority or Other||Adjusted Mean Difference|-48.65686|Standard Error of the Mean|3.02097|<|0.001|2-Sided|95.0|-54.6606|-42.65313|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632955|NCT02055976|3000391|Superiority or Other||Adjusted Mean Difference|-47.8521|Standard Error of the Mean|3.05746|<|0.001|2-Sided|95.0|-53.92668|-41.77751|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632956|NCT02055976|3000391|Superiority or Other||Adjusted Mean Difference|-33.30375|Standard Error of the Mean|3.07498|<|0.001|2-Sided|95.0|-39.41376|-27.19373|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632957|NCT02055976|3000391|Superiority or Other||Adjusted Mean Difference|-55.516|Standard Error of the Mean|2.91014|<|0.001|2-Sided|95.0|-61.29424|-49.73777|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632958|NCT02055976|3000391|Superiority or Other||Adjusted Mean Difference|-51.08604|Standard Error of the Mean|2.88356|<|0.001|2-Sided|95.0|-56.81235|-45.35973|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633238|NCT02054702|3000522|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in PANSS total score from baseline to week 6 for aripiprazole.|
1632959|NCT02055976|3000391|Superiority or Other||Adjusted Mean Difference|-41.92915|Standard Error of the Mean|2.83037|<|0.001|2-Sided|95.0|-47.55052|-36.30778|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632960|NCT02055976|3000392|Superiority or Other||Adjusted Mean Difference|-2.20298|Standard Error of the Mean|0.14142|<|0.001|2-Sided|95.0|-2.48399|-1.92197|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632961|NCT02055976|3000392|Superiority or Other||Adjusted Mean Difference|-2.00256|Standard Error of the Mean|0.14228|<|0.001|2-Sided|95.0|-2.28521|-1.7199|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632962|NCT02055976|3000392|Superiority or Other||Adjusted Mean Difference|-1.57311|Standard Error of the Mean|0.14333|<|0.001|2-Sided|95.0|-1.85788|-1.28834|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632963|NCT02055976|3000392|Superiority or Other||Adjusted Mean Difference|-1.86921|Standard Error of the Mean|0.13927|<|0.001|2-Sided|95.0|-2.14575|-1.59266|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632964|NCT02055976|3000392|Superiority or Other||Adjusted Mean Difference|-1.79615|Standard Error of the Mean|0.1379|<|0.001|2-Sided|95.0|-2.07001|-1.52229|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632965|NCT02055976|3000392|Superiority or Other||Adjusted Mean Difference|-1.35298|Standard Error of the Mean|0.13609|<|0.001|2-Sided|95.0|-1.62324|-1.08271|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632966|NCT02055976|3000392|Superiority or Other||Adjusted Mean Difference|-2.11359|Standard Error of the Mean|0.16038|<|0.001|2-Sided|95.0|-2.4323|-1.79489|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632967|NCT02055976|3000392|Superiority or Other||Adjusted Mean Difference|-2.01501|Standard Error of the Mean|0.16217|<|0.001|2-Sided|95.0|-2.33718|-1.69283|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632968|NCT02055976|3000392|Superiority or Other||Adjusted Mean Difference|-1.43281|Standard Error of the Mean|0.16311|<|0.001|2-Sided|95.0|-1.75689|-1.10872|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632969|NCT02055976|3000392|Superiority or Other||Adjusted Mean Difference|-2.23886|Standard Error of the Mean|0.13553|<|0.001|2-Sided|95.0|-2.50795|-1.96978|||Mixed Models Analysis|||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632970|NCT02055976|3000392|Superiority or Other||Adjusted Mean Difference|-2.07922|Standard Error of the Mean|0.13446|<|0.001|2-Sided|95.0|-2.34622|-1.81223|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632971|NCT02055976|3000392|Superiority or Other||Adjusted Mean Difference|-1.69928|Standard Error of the Mean|0.13216|<|0.001|2-Sided|95.0|-1.96175|-1.43682|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632972|NCT02055976|3000394|Superiority or Other||Adjusted Mean Difference|-61.305|Standard Error of the Mean|3.609|<|0.001|2-Sided|95.0|-68.477|-54.134|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632973|NCT02055976|3000394|Superiority or Other||Adjusted Mean Difference|-56.698|Standard Error of the Mean|3.633|<|0.001|2-Sided|95.0|-63.916|-49.48|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633239|NCT02054702|3000522|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in PANSS total score from baseline to week 6 for brexpiprazole.|
1632974|NCT02055976|3000394|Superiority or Other||Adjusted Mean Difference|-43.172|Standard Error of the Mean|3.647|<|0.001|2-Sided|95.0|-50.417|-35.926|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632975|NCT02055976|3000394|Superiority or Other||Adjusted Mean Difference|-56.354|Standard Error of the Mean|3.505|<|0.001|2-Sided|95.0|-63.315|-49.393|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632976|NCT02055976|3000394|Superiority or Other||Adjusted Mean Difference|-50.856|Standard Error of the Mean|3.451|<|0.001|2-Sided|95.0|-57.709|-44.002|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632977|NCT02055976|3000394|Superiority or Other||Adjusted Mean Difference|-37.991|Standard Error of the Mean|3.389|<|0.001|2-Sided|95.0|-44.721|-31.26|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632978|NCT02055976|3000394|Superiority or Other||Adjusted Mean Difference|-57.576|Standard Error of the Mean|3.544|<|0.001|2-Sided|95.0|-64.618|-50.533|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632979|NCT02055976|3000394|Superiority or Other||Adjusted Mean Difference|-56.009|Standard Error of the Mean|3.587|<|0.001|2-Sided|95.0|-63.135|-48.882|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632980|NCT02055976|3000394|Superiority or Other||Adjusted Mean Difference|-40.051|Standard Error of the Mean|3.595|<|0.001|2-Sided|95.0|-47.195|-32.908|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632981|NCT02055976|3000394|Superiority or Other||Adjusted Mean Difference|-66.868|Standard Error of the Mean|3.595|<|0.001|2-Sided|95.0|-74.007|-59.73|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632982|NCT02055976|3000394|Superiority or Other||Adjusted Mean Difference|-59.2|Standard Error of the Mean|3.554|<|0.001|2-Sided|95.0|-66.257|-52.143|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632983|NCT02055976|3000394|Superiority or Other||Adjusted Mean Difference|-46.772|Standard Error of the Mean|3.473|<|0.001|2-Sided|95.0|-53.671|-39.874|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632984|NCT02055976|3000395|Superiority or Other||Adjusted Mean Difference|-109.49|Standard Error of the Mean|6.054|<|0.001|2-Sided|95.0|-121.519|-97.462|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632985|NCT02055976|3000395|Superiority or Other||Adjusted Mean Difference|-100.666|Standard Error of the Mean|6.098|<|0.001|2-Sided|95.0|-112.781|-88.551|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632986|NCT02055976|3000395|Superiority or Other||Adjusted Mean Difference|-76.747|Standard Error of the Mean|6.118|<|0.001|2-Sided|95.0|-88.902|-64.593|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632987|NCT02055976|3000395|Superiority or Other||Adjusted Mean Difference|-89.683|Standard Error of the Mean|5.567|<|0.001|2-Sided|95.0|-100.74|-78.627|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632988|NCT02055976|3000395|Superiority or Other||Adjusted Mean Difference|-81.837|Standard Error of the Mean|5.48|<|0.001|2-Sided|95.0|-92.721|-70.954|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633240|NCT02054481|3000549|Superiority or Other||Hazard Ratio (HR)|0.1844|||<|0.0001|2-Sided|95.0|0.1|0.4|||Log Rank||||
1633299|NCT02048670|3000829|Superiority|||||||0.006|||||||Kruskal-Wallis|||Condition 2 - eyes closed, visual surround locked, platform locked|
1632989|NCT02055976|3000395|Superiority or Other||Adjusted Mean Difference|-61.124|Standard Error of the Mean|5.382|<|0.001|2-Sided|95.0|-71.813|-50.435|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632990|NCT02055976|3000395|Superiority or Other||Adjusted Mean Difference|-103.386|Standard Error of the Mean|6.525|<|0.001|2-Sided|95.0|-116.353|-90.42|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632991|NCT02055976|3000395|Superiority or Other||Adjusted Mean Difference|-100.638|Standard Error of the Mean|6.609|<|0.001|2-Sided|95.0|-113.768|-87.508|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632992|NCT02055976|3000395|Superiority or Other||Adjusted Mean Difference|-71.234|Standard Error of the Mean|6.622|<|0.001|2-Sided|95.0|-84.39|-58.077|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632993|NCT02055976|3000395|Superiority or Other||Adjusted Mean Difference|-106.077|Standard Error of the Mean|5.622|<|0.001|2-Sided|95.0|-117.239|-94.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632994|NCT02055976|3000395|Superiority or Other||Adjusted Mean Difference|-95.205|Standard Error of the Mean|5.556|<|0.001|2-Sided|95.0|-106.238|-84.172|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632995|NCT02055976|3000395|Superiority or Other||Adjusted Mean Difference|-76.189|Standard Error of the Mean|5.431|<|0.001|2-Sided|95.0|-86.975|-65.403|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632996|NCT02055976|3000397|Superiority or Other||Adjusted Mean Difference|-15.035|Standard Error of the Mean|9.389||0.056|2-Sided|95.0|-33.698|3.629|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632997|NCT02055976|3000397|Superiority or Other||Adjusted Mean Difference|-3.378|Standard Error of the Mean|9.464||0.361|2-Sided|95.0|-22.191|15.435|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632998|NCT02055976|3000397|Superiority or Other||Adjusted Mean Difference|-13.83|Standard Error of the Mean|9.326||0.071|2-Sided|95.0|-32.368|4.709|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1632999|NCT02055976|3000397|Superiority or Other||Adjusted Mean Difference|-14.994|Standard Error of the Mean|8.987||0.049|2-Sided|95.0|-32.858|2.87|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633000|NCT02055976|3000397|Superiority or Other||Adjusted Mean Difference|-24.352|Standard Error of the Mean|8.882||0.004|2-Sided|95.0|-42.008|-6.695|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633001|NCT02055976|3000397|Superiority or Other||Adjusted Mean Difference|-10.056|Standard Error of the Mean|8.801||0.128|2-Sided|95.0|-27.549|7.437|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633002|NCT02055976|3000397|Superiority or Other||Adjusted Mean Difference|0.369|Standard Error of the Mean|9.58||0.515|2-Sided|95.0|-18.668|19.407|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633003|NCT02055976|3000397|Superiority or Other||Adjusted Mean Difference|-2.511|Standard Error of the Mean|9.682||0.398|2-Sided|95.0|-21.748|16.727|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633300|NCT02048670|3000829|Superiority|||||||0.005|||||||Kruskal-Wallis|||Condition 1 - eyes open, visual surround locked, platform locked|
1633301|NCT02048072|3000831|Superiority or Other|||||||0.02|||||||t-test, 1 sided||||
1633004|NCT02055976|3000397|Superiority or Other||Adjusted Mean Difference|8.034|Standard Error of the Mean|9.553||0.799|2-Sided|95.0|-10.948|27.015|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633005|NCT02055976|3000397|Superiority or Other||Adjusted Mean Difference|-31.034|Standard Error of the Mean|7.917|<|0.001|2-Sided|95.0|-46.758|-15.31|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633006|NCT02055976|3000397|Superiority or Other||Adjusted Mean Difference|-21.11|Standard Error of the Mean|7.831|<|0.004|2-Sided|95.0|-36.665|-5.555|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633007|NCT02055976|3000397|Superiority or Other||Adjusted Mean Difference|-25.974|Standard Error of the Mean|7.674|<|0.001|2-Sided|95.0|-41.217|-10.731|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633008|NCT02055976|3000398|Superiority or Other||Adjusted Mean Difference|-19.435|Standard Error of the Mean|11.807||0.052|2-Sided|95.0|-42.902|4.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633009|NCT02055976|3000398|Superiority or Other||Adjusted Mean Difference|-5.654|Standard Error of the Mean|11.903||0.318|2-Sided|95.0|-29.311|18.004|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633010|NCT02055976|3000398|Superiority or Other||Adjusted Mean Difference|-17.978|Standard Error of the Mean|11.725||0.064|2-Sided|95.0|-41.282|5.326|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633011|NCT02055976|3000398|Superiority or Other||Adjusted Mean Difference|-34.933|Standard Error of the Mean|14.832||0.01|2-Sided|95.0|-64.41|-5.456|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633012|NCT02055976|3000398|Superiority or Other||Adjusted Mean Difference|-41.761|Standard Error of the Mean|14.676||0.003|2-Sided|95.0|-70.934|-12.588|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633013|NCT02055976|3000398|Superiority or Other||Adjusted Mean Difference|-22.003|Standard Error of the Mean|14.53||0.067|2-Sided|95.0|-50.882|6.875|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633014|NCT02055976|3000398|Superiority or Other||Adjusted Mean Difference|-5.649|Standard Error of the Mean|10.933||0.303|2-Sided|95.0|-27.376|16.079|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633015|NCT02055976|3000398|Superiority or Other||Adjusted Mean Difference|-8.563|Standard Error of the Mean|11.067||0.221|2-Sided|95.0|-30.554|13.427|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633016|NCT02055976|3000398|Superiority or Other||Adjusted Mean Difference|3.17|Standard Error of the Mean|10.906||0.614|2-Sided|95.0|-18.502|24.842|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633017|NCT02055976|3000398|Superiority or Other||Adjusted Mean Difference|-40.01|Standard Error of the Mean|11.16|<|0.001|2-Sided|95.0|-62.175|-17.845|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633018|NCT02055976|3000398|Superiority or Other||Adjusted Mean Difference|-29.186|Standard Error of the Mean|11.044|<|0.005|2-Sided|95.0|-51.123|-7.249|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633302|NCT02047643|3000853|Other|||||||0.66|||||||Fisher Exact|Two-sided Fisher Exact test|||
1633303|NCT02047643|3000854|Other|||||||0.45|||||||Fisher Exact|Two-sided Fisher Exact test|||
1633019|NCT02055976|3000398|Superiority or Other||Adjusted Mean Difference|-35.967|Standard Error of the Mean|10.822|<|0.001|2-Sided|95.0|-57.463|-14.472|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633020|NCT02055976|3000400|Superiority or Other||Adjusted Mean Difference|-32.443|Standard Error of the Mean|12.555||0.006|2-Sided|95.0|-57.4|-7.485|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633021|NCT02055976|3000400|Superiority or Other||Adjusted Mean Difference|-6.287|Standard Error of the Mean|12.705||0.311|2-Sided|95.0|-31.541|18.968|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633022|NCT02055976|3000400|Superiority or Other||Adjusted Mean Difference|-24.416|Standard Error of the Mean|12.718||0.029|2-Sided|95.0|-49.696|0.865|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633023|NCT02055976|3000400|Superiority or Other||Adjusted Mean Difference|-17.159|Standard Error of the Mean|10.535||0.054|2-Sided|95.0|-38.108|3.789|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633024|NCT02055976|3000400|Superiority or Other||Adjusted Mean Difference|-23.119|Standard Error of the Mean|10.461||0.015|2-Sided|95.0|-43.923|-2.315|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633025|NCT02055976|3000400|Superiority or Other||Adjusted Mean Difference|-12.911|Standard Error of the Mean|10.309||0.107|2-Sided|95.0|-33.411|7.589|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633026|NCT02055976|3000400|Superiority or Other||Adjusted Mean Difference|-2.646|Standard Error of the Mean|13.362||0.422|2-Sided|95.0|-29.206|23.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633027|NCT02055976|3000400|Superiority or Other||Adjusted Mean Difference|10.227|Standard Error of the Mean|13.586||0.773|2-Sided|95.0|-16.774|37.228|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633028|NCT02055976|3000400|Superiority or Other||Adjusted Mean Difference|-4.681|Standard Error of the Mean|13.601||0.366|2-Sided|95.0|-31.713|22.35|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633029|NCT02055976|3000400|Superiority or Other||Adjusted Mean Difference|-39.657|Standard Error of the Mean|7.29|<|0.001|2-Sided|95.0|-54.136|-25.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633030|NCT02055976|3000400|Superiority or Other||Adjusted Mean Difference|-29.187|Standard Error of the Mean|7.242|<|0.001|2-Sided|95.0|-43.571|-14.803|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633031|NCT02055976|3000400|Superiority or Other||Adjusted Mean Difference|-31.88|Standard Error of the Mean|7.071|<|0.001|2-Sided|95.0|-45.925|-17.836|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633032|NCT02055976|3000401|Superiority or Other||Adjusted Mean Difference|-5.271|Standard Error of the Mean|1.913||0.004|2-Sided|95.0|-9.074|-1.469|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633033|NCT02055976|3000401|Superiority or Other||Adjusted Mean Difference|-2.557|Standard Error of the Mean|1.937||0.095|2-Sided|95.0|-6.408|1.293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633304|NCT02047227|3000879|Superiority or Other||Mean Difference (Net)|-0.235||||0.054|2-Sided|95.0|-0.4741|0.003|||Poisson Regression Model||||
1633780|NCT02038881|3001869|Other||Diff in SC rate (Gr 1 - Gr 2) at Week 30|-9.6|||||2-Sided|95.0|-38.4|17.6|||||||
1633034|NCT02055976|3000401|Superiority or Other||Adjusted Mean Difference|-3.07|Standard Error of the Mean|1.915||0.056|2-Sided|95.0|-6.876|0.736|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633035|NCT02055976|3000401|Superiority or Other||Adjusted Mean Difference|-5.951|Standard Error of the Mean|2.458||0.009|2-Sided|95.0|-10.836|-1.066|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633036|NCT02055976|3000401|Superiority or Other||Adjusted Mean Difference|-6.764|Standard Error of the Mean|2.442||0.003|2-Sided|95.0|-11.617|-1.91|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633037|NCT02055976|3000401|Superiority or Other||Adjusted Mean Difference|-4.447|Standard Error of the Mean|2.406||0.034|2-Sided|95.0|-9.23|0.335|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633038|NCT02055976|3000401|Superiority or Other||Adjusted Mean Difference|-1.953|Standard Error of the Mean|1.761||0.135|2-Sided|95.0|-5.452|1.546|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633039|NCT02055976|3000401|Superiority or Other||Adjusted Mean Difference|-1.701|Standard Error of the Mean|1.793||0.173|2-Sided|95.0|-5.264|1.862|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633040|NCT02055976|3000401|Superiority or Other||Adjusted Mean Difference|-0.072|Standard Error of the Mean|1.773||0.484|2-Sided|95.0|-3.596|3.451|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633041|NCT02055976|3000401|Superiority or Other||Adjusted Mean Difference|-8.755|Standard Error of the Mean|1.479|<|0.001|2-Sided|95.0|-11.692|-5.817|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633042|NCT02055976|3000401|Superiority or Other||Adjusted Mean Difference|-6.693|Standard Error of the Mean|1.469|<|0.001|2-Sided|95.0|-9.61|-3.776|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633043|NCT02055976|3000401|Superiority or Other||Adjusted Mean Difference|-7.462|Standard Error of the Mean|1.434|<|0.001|2-Sided|95.0|-10.311|-4.614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633044|NCT02055976|3000403|Superiority or Other||Adjusted Mean Difference|8.898|Standard Error of the Mean|2.84||0.001|2-Sided|95.0|3.252|14.544|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633045|NCT02055976|3000403|Superiority or Other||Adjusted Mean Difference|8.543|Standard Error of the Mean|2.876||0.002|2-Sided|95.0|2.827|14.26|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633046|NCT02055976|3000403|Superiority or Other||Adjusted Mean Difference|9.029|Standard Error of the Mean|2.858||0.001|2-Sided|95.0|3.348|14.71|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633047|NCT02055976|3000403|Superiority or Other||Adjusted Mean Difference|9.571|Standard Error of the Mean|3.384||0.003|2-Sided|95.0|2.847|16.295|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633048|NCT02055976|3000403|Superiority or Other||Adjusted Mean Difference|16.252|Standard Error of the Mean|3.367|<|0.001|2-Sided|95.0|9.56|22.943|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633344|NCT02046993|3000918|Superiority or Other|||||||0.02|||||||McNemar|||Comparison of percentage of subjects doing HBPM at 3rd month from baseline within intervention group|
1633049|NCT02055976|3000403|Superiority or Other||Adjusted Mean Difference|10.004|Standard Error of the Mean|3.326|<|0.002|2-Sided|95.0|3.395|16.612|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633050|NCT02055976|3000403|Superiority or Other||Adjusted Mean Difference|9.826|Standard Error of the Mean|2.878|<|0.001|2-Sided|95.0|4.103|15.548|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633051|NCT02055976|3000403|Superiority or Other||Adjusted Mean Difference|9.56|Standard Error of the Mean|2.927|<|0.001|2-Sided|95.0|3.743|15.377|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633052|NCT02055976|3000403|Superiority or Other||Adjusted Mean Difference|4.112|Standard Error of the Mean|2.909|<|0.081|2-Sided|95.0|-1.671|9.895|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633053|NCT02055976|3000403|Superiority or Other||Adjusted Mean Difference|13.288|Standard Error of the Mean|2.593|<|0.001|2-Sided|95.0|8.137|18.438|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633054|NCT02055976|3000403|Superiority or Other||Adjusted Mean Difference|16.546|Standard Error of the Mean|2.576|<|0.001|2-Sided|95.0|11.43|21.663|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633055|NCT02055976|3000403|Superiority or Other||Adjusted Mean Difference|13.389|Standard Error of the Mean|2.525|<|0.001|2-Sided|95.0|8.373|18.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633056|NCT02055976|3000404|Superiority or Other||Adjusted Mean Difference|4.301|Standard Error of the Mean|1.832||0.011|2-Sided|95.0|0.658|7.943|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633057|NCT02055976|3000404|Superiority or Other||Adjusted Mean Difference|5.096|Standard Error of the Mean|1.853||0.004|2-Sided|95.0|1.413|8.78|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633058|NCT02055976|3000404|Superiority or Other||Adjusted Mean Difference|5.065|Standard Error of the Mean|1.843||0.004|2-Sided|95.0|1.402|8.728|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633059|NCT02055976|3000404|Superiority or Other||Adjusted Mean Difference|5.264|Standard Error of the Mean|2.072||0.006|2-Sided|95.0|1.147|9.38|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633060|NCT02055976|3000404|Superiority or Other||Adjusted Mean Difference|9.251|Standard Error of the Mean|2.062|<|0.001|2-Sided|95.0|5.153|13.349|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633061|NCT02055976|3000404|Superiority or Other||Adjusted Mean Difference|5.888|Standard Error of the Mean|2.035|<|0.002|2-Sided|95.0|1.844|9.932|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633062|NCT02055976|3000404|Superiority or Other||Adjusted Mean Difference|4.712|Standard Error of the Mean|1.789|<|0.005|2-Sided|95.0|1.156|8.268|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633063|NCT02055976|3000404|Superiority or Other||Adjusted Mean Difference|5.578|Standard Error of the Mean|1.815|<|0.001|2-Sided|95.0|1.972|9.185|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633241|NCT02054481|3000550|Superiority or Other||Mean Difference (Net)|21.2||||0.0072|2-Sided|95.0|5.7|36.6|||Cochran-Mantel-Haenszel|Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara||
1633064|NCT02055976|3000404|Superiority or Other||Adjusted Mean Difference|2.228|Standard Error of the Mean|1.806|<|0.11|2-Sided|95.0|-1.361|5.818|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633065|NCT02055976|3000404|Superiority or Other||Adjusted Mean Difference|7.255|Standard Error of the Mean|1.47|<|0.001|2-Sided|95.0|4.336|10.175|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633066|NCT02055976|3000404|Superiority or Other||Adjusted Mean Difference|9.29|Standard Error of the Mean|1.46|<|0.001|2-Sided|95.0|6.389|12.19|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633067|NCT02055976|3000404|Superiority or Other||Adjusted Mean Difference|7.663|Standard Error of the Mean|1.431|<|0.001|2-Sided|95.0|4.82|10.506|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633068|NCT02055976|3000406|Superiority or Other||Adjusted Mean Difference|-32.847|Standard Error of the Mean|7.8576|<|0.001|2-Sided|95.0|-48.465|-17.2289|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633069|NCT02055976|3000406|Superiority or Other||Adjusted Mean Difference|-31.3176|Standard Error of the Mean|7.9032|<|0.001|2-Sided|95.0|-47.0238|-15.6114|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633070|NCT02055976|3000406|Superiority or Other||Adjusted Mean Difference|-32.9411|Standard Error of the Mean|7.8656|<|0.001|2-Sided|95.0|-48.5748|-17.3075|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633071|NCT02055976|3000406|Superiority or Other||Adjusted Mean Difference|-36.8453|Standard Error of the Mean|5.3084|<|0.001|2-Sided|95.0|-47.3864|-26.3041|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633072|NCT02055976|3000406|Superiority or Other||Adjusted Mean Difference|-36.7882|Standard Error of the Mean|5.264|<|0.001|2-Sided|95.0|-47.2423|-26.3341|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633073|NCT02055976|3000406|Superiority or Other||Adjusted Mean Difference|-18.3898|Standard Error of the Mean|5.1768|<|0.001|2-Sided|95.0|-28.6698|-8.1097|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633074|NCT02055976|3000406|Superiority or Other||Adjusted Mean Difference|-26.5155|Standard Error of the Mean|8.8387|<|0.002|2-Sided|95.0|-44.0795|-8.9515|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633075|NCT02055976|3000406|Superiority or Other||Adjusted Mean Difference|-19.2255|Standard Error of the Mean|8.9203|<|0.017|2-Sided|95.0|-36.9471|-1.5038|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633076|NCT02055976|3000406|Superiority or Other||Adjusted Mean Difference|-24.1677|Standard Error of the Mean|8.8755|<|0.004|2-Sided|95.0|-41.8023|-6.5332|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633077|NCT02055976|3000406|Superiority or Other||Adjusted Mean Difference|-27.163|Standard Error of the Mean|10.5402|<|0.006|2-Sided|95.0|-48.0927|-6.2332|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633078|NCT02055976|3000406|Superiority or Other||Adjusted Mean Difference|-40.5908|Standard Error of the Mean|10.4568|<|0.001|2-Sided|95.0|-61.3577|-19.824|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633242|NCT02054481|3000552|Superiority or Other||Mean Difference (Net)|19.8||||0.03|2-Sided|95.0|1.9|37.7|||Cochran-Mantel-Haenszel|Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara||
1633079|NCT02055976|3000406|Superiority or Other||Adjusted Mean Difference|-27.4492|Standard Error of the Mean|10.2401|<|0.004|2-Sided|95.0|-47.7872|-7.1112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633080|NCT02055976|3000407|Superiority or Other||Adjusted Mean Difference|-4.4374|Standard Error of the Mean|0.9187|<|0.001|2-Sided|95.0|-6.263|-2.6118|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633081|NCT02055976|3000407|Superiority or Other||Adjusted Mean Difference|-4.7094|Standard Error of the Mean|0.9244|<|0.001|2-Sided|95.0|-6.5459|-2.8729|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633082|NCT02055976|3000407|Superiority or Other||Adjusted Mean Difference|-3.9228|Standard Error of the Mean|0.9199|<|0.001|2-Sided|95.0|-5.7506|-2.095|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633083|NCT02055976|3000407|Superiority or Other||Adjusted Mean Difference|-6.3962|Standard Error of the Mean|1.3233|<|0.001|2-Sided|95.0|-9.0247|-3.7677|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633084|NCT02055976|3000407|Superiority or Other||Adjusted Mean Difference|-6.3569|Standard Error of the Mean|1.3157|<|0.001|2-Sided|95.0|-8.9706|-3.7432|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633085|NCT02055976|3000407|Superiority or Other||Adjusted Mean Difference|-3.2914|Standard Error of the Mean|1.2954|<|0.006|2-Sided|95.0|-5.8649|-0.7178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633086|NCT02055976|3000407|Superiority or Other||Adjusted Mean Difference|-4.1778|Standard Error of the Mean|1.0269|<|0.001|2-Sided|95.0|-6.2184|-2.1372|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633087|NCT02055976|3000407|Superiority or Other||Adjusted Mean Difference|-3.6209|Standard Error of the Mean|1.0367|<|0.001|2-Sided|95.0|-5.6804|-1.5614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633088|NCT02055976|3000407|Superiority or Other||Adjusted Mean Difference|-3.0629|Standard Error of the Mean|1.032|<|0.002|2-Sided|95.0|-5.1132|-1.0125|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633089|NCT02055976|3000407|Superiority or Other||Adjusted Mean Difference|-7.3118|Standard Error of the Mean|1.3505|<|0.001|2-Sided|95.0|-9.9935|-4.6301|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633090|NCT02055976|3000407|Superiority or Other||Adjusted Mean Difference|-7.1983|Standard Error of the Mean|1.3462|<|0.001|2-Sided|95.0|-9.8718|-4.5249|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633091|NCT02055976|3000407|Superiority or Other||Adjusted Mean Difference|-4.9203|Standard Error of the Mean|1.3242|<|0.001|2-Sided|95.0|-7.5504|-2.2901|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633092|NCT02055976|3000409|Superiority or Other||Adjusted Mean Difference|2.4558|Standard Error of the Mean|2.323||0.147|2-Sided|95.0|-2.1608|7.0724|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633093|NCT02055976|3000409|Superiority or Other||Adjusted Mean Difference|5.7096|Standard Error of the Mean|2.3367||0.008|2-Sided|95.0|1.0659|10.3532|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633243|NCT02054481|3000553|Superiority or Other||Mean Difference (Net)|10.1||||0.0706|2-Sided|95.0|-0.8|21.1|||Cochran-Mantel-Haenszel|Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara||
1633094|NCT02055976|3000409|Superiority or Other||Adjusted Mean Difference|0.6078|Standard Error of the Mean|2.3322||0.397|2-Sided|95.0|-4.0274|5.2431|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633095|NCT02055976|3000409|Superiority or Other||Adjusted Mean Difference|0.3113|Standard Error of the Mean|2.4909||0.45|2-Sided|95.0|-4.6358|5.2584|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633096|NCT02055976|3000409|Superiority or Other||Adjusted Mean Difference|2.1376|Standard Error of the Mean|2.4716||0.195|2-Sided|95.0|-2.7718|7.0469|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633097|NCT02055976|3000409|Superiority or Other||Adjusted Mean Difference|2.1827|Standard Error of the Mean|2.4251||0.185|2-Sided|95.0|-2.6334|6.9988|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633098|NCT02055976|3000409|Superiority or Other||Adjusted Mean Difference|5.2393|Standard Error of the Mean|2.7396||0.03|2-Sided|95.0|-0.2058|10.6845|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633099|NCT02055976|3000409|Superiority or Other||Adjusted Mean Difference|6.1048|Standard Error of the Mean|2.7784||0.015|2-Sided|95.0|0.5833|11.6263|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633100|NCT02055976|3000409|Superiority or Other||Adjusted Mean Difference|2.3254|Standard Error of the Mean|2.7702||0.202|2-Sided|95.0|-3.1801|7.831|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633101|NCT02055976|3000409|Superiority or Other||Adjusted Mean Difference|0.8224|Standard Error of the Mean|2.1126||0.349|2-Sided|95.0|-3.3733|5.0182|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633102|NCT02055976|3000409|Superiority or Other||Adjusted Mean Difference|3.2608|Standard Error of the Mean|2.0965||0.062|2-Sided|95.0|-0.9035|7.425|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633103|NCT02055976|3000409|Superiority or Other||Adjusted Mean Difference|2.0813|Standard Error of the Mean|2.0411||0.155|2-Sided|95.0|-1.973|6.1356|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633104|NCT02055976|3000410|Superiority or Other||Adjusted Mean Difference|0.834|Standard Error of the Mean|0.7442||0.133|2-Sided|95.0|-0.6451|2.313|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633105|NCT02055976|3000410|Superiority or Other||Adjusted Mean Difference|1.9322|Standard Error of the Mean|0.7488||0.006|2-Sided|95.0|0.4441|3.4203|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633106|NCT02055976|3000410|Superiority or Other||Adjusted Mean Difference|0.3239|Standard Error of the Mean|0.7472||0.333|2-Sided|95.0|-1.1611|1.8089|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633107|NCT02055976|3000410|Superiority or Other||Adjusted Mean Difference|0.2624|Standard Error of the Mean|0.8053||0.373|2-Sided|95.0|-1.337|1.8618|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633108|NCT02055976|3000410|Superiority or Other||Adjusted Mean Difference|0.8807|Standard Error of the Mean|0.799||0.137|2-Sided|95.0|-0.7064|2.4678|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633345|NCT02046993|3000918|Superiority or Other|||||||0.27|||||||Chi-squared|||comparison of the percentage of patients doing HBPM between intervention and control group at baseline|
1633109|NCT02055976|3000410|Superiority or Other||Adjusted Mean Difference|0.8585|Standard Error of the Mean|0.7844||0.138|2-Sided|95.0|-0.6992|2.4163|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633110|NCT02055976|3000410|Superiority or Other||Adjusted Mean Difference|1.7116|Standard Error of the Mean|0.852||0.024|2-Sided|95.0|0.0184|3.4049|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633111|NCT02055976|3000410|Superiority or Other||Adjusted Mean Difference|2.0071|Standard Error of the Mean|0.8641||0.011|2-Sided|95.0|0.2899|3.7242|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633112|NCT02055976|3000410|Superiority or Other||Adjusted Mean Difference|0.8055|Standard Error of the Mean|0.8615||0.176|2-Sided|95.0|-0.9066|2.5177|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633113|NCT02055976|3000410|Superiority or Other||Adjusted Mean Difference|0.2445|Standard Error of the Mean|0.6511||0.354|2-Sided|95.0|-1.0486|1.5375|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633114|NCT02055976|3000410|Superiority or Other||Adjusted Mean Difference|1.0574|Standard Error of the Mean|0.6461||0.053|2-Sided|95.0|-0.2259|2.3406|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633115|NCT02055976|3000410|Superiority or Other||Adjusted Mean Difference|0.7208|Standard Error of the Mean|0.6289||0.127|2-Sided|95.0|-0.5283|1.97|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633116|NCT02055976|3000412|Superiority or Other||Adjusted Mean Difference|4.168|Standard Error of the Mean|1.748||0.01|2-Sided|95.0|0.693|7.642|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633117|NCT02055976|3000412|Superiority or Other||Adjusted Mean Difference|6.91|Standard Error of the Mean|1.766|<|0.001|2-Sided|95.0|3.4|10.421|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633118|NCT02055976|3000412|Superiority or Other||Adjusted Mean Difference|5.846|Standard Error of the Mean|1.778|<|0.001|2-Sided|95.0|2.312|9.38|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633119|NCT02055976|3000412|Superiority or Other||Adjusted Mean Difference|8.056|Standard Error of the Mean|2.302|<|0.001|2-Sided|95.0|3.484|12.629|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633120|NCT02055976|3000412|Superiority or Other||Adjusted Mean Difference|10.213|Standard Error of the Mean|2.271|<|0.001|2-Sided|95.0|5.702|14.724|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633121|NCT02055976|3000412|Superiority or Other||Adjusted Mean Difference|5.936|Standard Error of the Mean|2.266|<|0.005|2-Sided|95.0|1.435|10.437|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633122|NCT02055976|3000412|Superiority or Other||Adjusted Mean Difference|9.075|Standard Error of the Mean|2.122|<|0.001|2-Sided|95.0|4.856|13.293|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633123|NCT02055976|3000412|Superiority or Other||Adjusted Mean Difference|7.331|Standard Error of the Mean|2.161|<|0.001|2-Sided|95.0|3.037|11.624|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633244|NCT02054481|3000554|Superiority or Other||Mean Difference (Net)|27.1||||0.0008|2-Sided|95.0|11.3|42.9|||Cochran-Mantel-Haenszel|Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara||
1633124|NCT02055976|3000412|Superiority or Other||Adjusted Mean Difference|4.859|Standard Error of the Mean|2.173|<|0.014|2-Sided|95.0|0.541|9.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633125|NCT02055976|3000412|Superiority or Other||Adjusted Mean Difference|9.069|Standard Error of the Mean|1.945|<|0.001|2-Sided|95.0|5.206|12.932|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633126|NCT02055976|3000412|Superiority or Other||Adjusted Mean Difference|10.786|Standard Error of the Mean|1.918|<|0.001|2-Sided|95.0|6.976|14.597|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633127|NCT02055976|3000412|Superiority or Other||Adjusted Mean Difference|6.079|Standard Error of the Mean|1.905|<|0.001|2-Sided|95.0|2.296|9.863|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633128|NCT02055976|3000413|Superiority or Other||Adjusted Mean Difference|5.767|Standard Error of the Mean|2.565||0.014|2-Sided|95.0|0.67|10.864|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633129|NCT02055976|3000413|Superiority or Other||Adjusted Mean Difference|10.23|Standard Error of the Mean|2.592|<|0.001|2-Sided|95.0|5.079|15.381|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633130|NCT02055976|3000413|Superiority or Other||Adjusted Mean Difference|8.132|Standard Error of the Mean|2.609|<|0.001|2-Sided|95.0|2.947|13.316|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633131|NCT02055976|3000413|Superiority or Other||Adjusted Mean Difference|11.168|Standard Error of the Mean|3.317|<|0.001|2-Sided|95.0|4.58|17.757|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633132|NCT02055976|3000413|Superiority or Other||Adjusted Mean Difference|14.708|Standard Error of the Mean|3.272|<|0.001|2-Sided|95.0|8.208|21.208|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633133|NCT02055976|3000413|Superiority or Other||Adjusted Mean Difference|8.644|Standard Error of the Mean|3.266|<|0.005|2-Sided|95.0|2.157|15.13|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633134|NCT02055976|3000413|Superiority or Other||Adjusted Mean Difference|12.895|Standard Error of the Mean|2.969|<|0.001|2-Sided|95.0|6.993|18.796|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633135|NCT02055976|3000413|Superiority or Other||Adjusted Mean Difference|10.565|Standard Error of the Mean|3.023|<|0.001|2-Sided|95.0|4.556|16.573|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633136|NCT02055976|3000413|Superiority or Other||Adjusted Mean Difference|6.804|Standard Error of the Mean|3.041|<|0.014|2-Sided|95.0|0.761|12.847|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633137|NCT02055976|3000413|Superiority or Other||Adjusted Mean Difference|12.321|Standard Error of the Mean|2.7|<|0.001|2-Sided|95.0|6.959|17.683|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633138|NCT02055976|3000413|Superiority or Other||Adjusted Mean Difference|15.429|Standard Error of the Mean|2.662|<|0.001|2-Sided|95.0|10.141|20.717|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633245|NCT02054481|3000555|Superiority or Other||Mean Difference (Net)|21.1||||0.0062|2-Sided|95.0|6.0|36.2|||Cochran-Mantel-Haenszel|Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|Week 24|
1633139|NCT02055976|3000413|Superiority or Other||Adjusted Mean Difference|8.896|Standard Error of the Mean|2.643|<|0.001|2-Sided|95.0|3.646|14.145|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633140|NCT02055976|3000415|Superiority or Other||Adjusted Mean Difference|-58.62|Standard Error of the Mean|3.533|<|0.001|2-Sided|95.0|-65.64|-51.6|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633141|NCT02055976|3000415|Superiority or Other||Adjusted Mean Difference|-53.81|Standard Error of the Mean|3.56|<|0.001|2-Sided|95.0|-60.883|-46.737|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633142|NCT02055976|3000415|Superiority or Other||Adjusted Mean Difference|-40.045|Standard Error of the Mean|3.56|<|0.001|2-Sided|95.0|-47.118|-32.971|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633143|NCT02055976|3000415|Superiority or Other||Adjusted Mean Difference|-55.114|Standard Error of the Mean|3.526|<|0.001|2-Sided|95.0|-62.116|-48.112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633144|NCT02055976|3000415|Superiority or Other||Adjusted Mean Difference|-48.845|Standard Error of the Mean|3.456|<|0.001|2-Sided|95.0|-55.709|-41.982|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633145|NCT02055976|3000415|Superiority or Other||Adjusted Mean Difference|-35.288|Standard Error of the Mean|3.41|<|0.001|2-Sided|95.0|-42.059|-28.516|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633146|NCT02055976|3000415|Superiority or Other||Adjusted Mean Difference|-55.489|Standard Error of the Mean|3.496|<|0.001|2-Sided|95.0|-62.436|-48.542|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633147|NCT02055976|3000415|Superiority or Other||Adjusted Mean Difference|-53.296|Standard Error of the Mean|3.538|<|0.001|2-Sided|95.0|-60.325|-46.267|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633148|NCT02055976|3000415|Superiority or Other||Adjusted Mean Difference|-36.428|Standard Error of the Mean|3.535|<|0.001|2-Sided|95.0|-43.451|-29.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633149|NCT02055976|3000415|Superiority or Other||Adjusted Mean Difference|-64.729|Standard Error of the Mean|3.682|<|0.001|2-Sided|95.0|-72.039|-57.419|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633150|NCT02055976|3000415|Superiority or Other||Adjusted Mean Difference|-57.962|Standard Error of the Mean|3.628|<|0.001|2-Sided|95.0|-65.167|-50.758|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633151|NCT02055976|3000415|Superiority or Other||Adjusted Mean Difference|-43.265|Standard Error of the Mean|3.566|<|0.001|2-Sided|95.0|-50.347|-36.183|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633152|NCT02055976|3000416|Superiority or Other||Adjusted Mean Difference|-59.608|Standard Error of the Mean|3.52|<|0.001|2-Sided|95.0|-66.602|-52.614|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633153|NCT02055976|3000416|Superiority or Other||Adjusted Mean Difference|-54.634|Standard Error of the Mean|3.549|<|0.001|2-Sided|95.0|-61.685|-47.583|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633246|NCT02054481|3000555|Superiority or Other||Mean Difference (Net)|14.6||||0.0355|2-Sided|95.0|1.0|28.2|||Cochran-Mantel-Haenszel|Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara|Week 12|
1633154|NCT02055976|3000416|Superiority or Other||Adjusted Mean Difference|-40.474|Standard Error of the Mean|3.547|<|0.001|2-Sided|95.0|-47.523|-33.426|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633155|NCT02055976|3000416|Superiority or Other||Adjusted Mean Difference|-51.5|Standard Error of the Mean|3.305|<|0.001|2-Sided|95.0|-58.063|-44.937|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633156|NCT02055976|3000416|Superiority or Other||Adjusted Mean Difference|-45.956|Standard Error of the Mean|3.239|<|0.001|2-Sided|95.0|-52.388|-39.523|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633157|NCT02055976|3000416|Superiority or Other||Adjusted Mean Difference|-33.262|Standard Error of the Mean|3.196|<|0.001|2-Sided|95.0|-39.608|-26.915|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633158|NCT02055976|3000416|Superiority or Other||Adjusted Mean Difference|-56.517|Standard Error of the Mean|3.688|<|0.001|2-Sided|95.0|-63.845|-49.189|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633159|NCT02055976|3000416|Superiority or Other||Adjusted Mean Difference|-54.683|Standard Error of the Mean|3.734|<|0.001|2-Sided|95.0|-62.102|-47.265|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633160|NCT02055976|3000416|Superiority or Other||Adjusted Mean Difference|-36.589|Standard Error of the Mean|3.73|<|0.001|2-Sided|95.0|-43.999|-29.178|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633161|NCT02055976|3000416|Superiority or Other||Adjusted Mean Difference|-60.549|Standard Error of the Mean|3.453|<|0.001|2-Sided|95.0|-67.403|-53.694|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633162|NCT02055976|3000416|Superiority or Other||Adjusted Mean Difference|-54.787|Standard Error of the Mean|3.402|<|0.001|2-Sided|95.0|-61.543|-48.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633163|NCT02055976|3000416|Superiority or Other||Adjusted Mean Difference|-41.118|Standard Error of the Mean|3.344|<|0.001|2-Sided|95.0|-47.76|-34.476|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633164|NCT02055976|3000418|Superiority or Other||Adjusted Mean Difference|-43.947|Standard Error of the Mean|2.869|<|0.001|2-Sided|95.0|-49.647|-38.247|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633165|NCT02055976|3000418|Superiority or Other||Adjusted Mean Difference|-40.019|Standard Error of the Mean|2.887|<|0.001|2-Sided|95.0|-45.754|-34.285|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633166|NCT02055976|3000418|Superiority or Other||Adjusted Mean Difference|-30.847|Standard Error of the Mean|2.879|<|0.001|2-Sided|95.0|-36.568|-25.127|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633167|NCT02055976|3000418|Superiority or Other||Adjusted Mean Difference|-38.76|Standard Error of the Mean|2.77|<|0.001|2-Sided|95.0|-44.262|-33.258|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633168|NCT02055976|3000418|Superiority or Other||Adjusted Mean Difference|-33.49|Standard Error of the Mean|2.741|<|0.001|2-Sided|95.0|-38.934|-28.047|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633247|NCT02054481|3000556|Superiority or Other||Mean Difference (Net)|36.4|||<|0.0001|2-Sided|95.0|19.0|53.8|||Cochran-Mantel-Haenszel|Adjusted for weight (=<100kg vs >100kg) & prior exposure to 2 or more tumour necrosis factor antagonists with discontinuation due to lack of efficacy|Difference calculated as BI 90+180 mg minus Stelara||
1633169|NCT02055976|3000418|Superiority or Other||Adjusted Mean Difference|-25.374|Standard Error of the Mean|2.69|<|0.001|2-Sided|95.0|-30.717|-20.032|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633170|NCT02055976|3000418|Superiority or Other||Adjusted Mean Difference|-41.372|Standard Error of the Mean|2.983|<|0.001|2-Sided|95.0|-47.299|-35.445|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633171|NCT02055976|3000418|Superiority or Other||Adjusted Mean Difference|-39.525|Standard Error of the Mean|3.018|<|0.001|2-Sided|95.0|-45.52|-33.531|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633172|NCT02055976|3000418|Superiority or Other||Adjusted Mean Difference|-30.137|Standard Error of the Mean|3.006|<|0.001|2-Sided|95.0|-36.11|-24.164|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633173|NCT02055976|3000418|Superiority or Other||Adjusted Mean Difference|-45.889|Standard Error of the Mean|2.8|<|0.001|2-Sided|95.0|-51.45|-40.329|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633174|NCT02055976|3000418|Superiority or Other||Adjusted Mean Difference|-39.88|Standard Error of the Mean|2.781|<|0.001|2-Sided|95.0|-45.403|-34.358|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633175|NCT02055976|3000418|Superiority or Other||Adjusted Mean Difference|-31.642|Standard Error of the Mean|2.717|<|0.001|2-Sided|95.0|-37.039|-26.246|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633176|NCT02055976|3000419|Superiority or Other||Adjusted Mean Difference|-104.859|Standard Error of the Mean|6.654|<|0.001|2-Sided|95.0|-118.079|-91.639|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633177|NCT02055976|3000419|Superiority or Other||Adjusted Mean Difference|-95.428|Standard Error of the Mean|6.697|<|0.001|2-Sided|95.0|-108.732|-82.124|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633178|NCT02055976|3000419|Superiority or Other||Adjusted Mean Difference|-73.879|Standard Error of the Mean|6.678|<|0.001|2-Sided|95.0|-87.147|-60.612|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633179|NCT02055976|3000419|Superiority or Other||Adjusted Mean Difference|-83.065|Standard Error of the Mean|5.913|<|0.001|2-Sided|95.0|-94.807|-71.323|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633180|NCT02055976|3000419|Superiority or Other||Adjusted Mean Difference|-72.211|Standard Error of the Mean|5.848|<|0.001|2-Sided|95.0|-83.825|-60.597|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633181|NCT02055976|3000419|Superiority or Other||Adjusted Mean Difference|-55.191|Standard Error of the Mean|5.741|<|0.001|2-Sided|95.0|-66.592|-43.791|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633182|NCT02055976|3000419|Superiority or Other||Adjusted Mean Difference|-98.519|Standard Error of the Mean|7.15|<|0.001|2-Sided|95.0|-112.727|-84.311|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633183|NCT02055976|3000419|Superiority or Other||Adjusted Mean Difference|-94.959|Standard Error of the Mean|7.236|<|0.001|2-Sided|95.0|-109.333|-80.585|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633248|NCT02054338|3000557|Superiority||Hazard Ratio (HR)|11.3||||0.1|2-Sided|95.0|8.7|14.4|||Log Rank||||
1633249|NCT02054338|3000558|Superiority||Hazard Ratio (HR)|0.98||||0.86|2-Sided|95.0|0.87|1.19|||Log Rank||||
1633184|NCT02055976|3000419|Superiority or Other||Adjusted Mean Difference|-71.435|Standard Error of the Mean|7.209|<|0.001|2-Sided|95.0|-85.757|-57.112|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633185|NCT02055976|3000419|Superiority or Other||Adjusted Mean Difference|-98.273|Standard Error of the Mean|5.898|<|0.001|2-Sided|95.0|-109.983|-86.563|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633186|NCT02055976|3000419|Superiority or Other||Adjusted Mean Difference|-86.446|Standard Error of the Mean|5.855|<|0.001|2-Sided|95.0|-98.074|-74.818|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633187|NCT02055976|3000419|Superiority or Other||Adjusted Mean Difference|-69.537|Standard Error of the Mean|5.721|<|0.001|2-Sided|95.0|-80.9|-58.175|||Mixed Models Analysis|One-sided p-value (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633188|NCT02055976|3000421|Superiority or Other||Adjusted Mean Difference|-102.184|Standard Error of the Mean|5.919|<|0.001|2-Sided|95.0|-113.945|-90.424|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113:Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633189|NCT02055976|3000421|Superiority or Other||Adjusted Mean Difference|-96.222|Standard Error of the Mean|5.948|<|0.001|2-Sided|95.0|-108.039|-84.405|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633190|NCT02055976|3000421|Superiority or Other||Adjusted Mean Difference|-72.573|Standard Error of the Mean|5.983|<|0.001|2-Sided|95.0|-84.461|-60.684|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633191|NCT02055976|3000421|Superiority or Other||Adjusted Mean Difference|-81.239|Standard Error of the Mean|4.885|<|0.001|2-Sided|95.0|-90.939|-71.538|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633192|NCT02055976|3000421|Superiority or Other||Adjusted Mean Difference|-73.813|Standard Error of the Mean|4.881|<|0.001|2-Sided|95.0|-83.507|-64.119|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633193|NCT02055976|3000421|Superiority or Other||Adjusted Mean Difference|-56.225|Standard Error of the Mean|4.736|<|0.001|2-Sided|95.0|-65.63|-46.819|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 113: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633194|NCT02055976|3000421|Superiority or Other||Adjusted Mean Difference|-98.533|Standard Error of the Mean|6.145|<|0.001|2-Sided|95.0|-110.743|-86.323|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85: Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633195|NCT02055976|3000421|Superiority or Other||Adjusted Mean Difference|-96.206|Standard Error of the Mean|6.209|<|0.001|2-Sided|95.0|-108.541|-83.872|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633196|NCT02055976|3000421|Superiority or Other||Adjusted Mean Difference|-71.724|Standard Error of the Mean|6.243|<|0.001|2-Sided|95.0|-84.128|-59.321|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633197|NCT02055976|3000421|Superiority or Other||Adjusted Mean Difference|-93.327|Standard Error of the Mean|4.949|<|0.001|2-Sided|95.0|-103.153|-83.501|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633198|NCT02055976|3000421|Superiority or Other||Adjusted Mean Difference|-87.122|Standard Error of the Mean|4.959|<|0.001|2-Sided|95.0|-96.969|-77.275|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633295|NCT02048670|3000829|Superiority|||||||0.003|||||||Kruskal-Wallis|||Condition 6 - eyes open, visual surround unlocked, platform unlocked|
1633296|NCT02048670|3000829|Superiority|||||||0.985|||||||Kruskal-Wallis|||Condition 5 - eyes closed, visual surround locked, platform unlocked|
1633199|NCT02055976|3000421|Superiority or Other||Adjusted Mean Difference|-67.254|Standard Error of the Mean|4.785|<|0.001|2-Sided|95.0|-76.757|-57.752|||Mixed Models Analysis|One-sided p-values (unadjusted for multiplicity) was derived from the MMRM model.||Day 85 : Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633200|NCT02055976|3000423|Superiority or Other||Adjusted Mean Difference|-66.691|Standard Error of the Mean|4.226|<|0.001|2-Sided|95.0|-75.088|-58.295|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633201|NCT02055976|3000423|Superiority or Other||Adjusted Mean Difference|-63.346|Standard Error of the Mean|4.244|<|0.001|2-Sided|95.0|-71.776|-54.915|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633202|NCT02055976|3000423|Superiority or Other||Adjusted Mean Difference|-47.578|Standard Error of the Mean|4.273|<|0.001|2-Sided|95.0|-56.067|-39.088|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633203|NCT02055976|3000423|Superiority or Other||Adjusted Mean Difference|-61.384|Standard Error of the Mean|3.7|<|0.001|2-Sided|95.0|-68.733|-54.035|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633204|NCT02055976|3000423|Superiority or Other||Adjusted Mean Difference|-56.262|Standard Error of the Mean|3.696|<|0.001|2-Sided|95.0|-63.603|-48.921|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633205|NCT02055976|3000423|Superiority or Other||Adjusted Mean Difference|-42.293|Standard Error of the Mean|3.587|<|0.001|2-Sided|95.0|-49.417|-35.168|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633206|NCT02055976|3000424|Superiority or Other||Adjusted Mean Difference|-64.268|Standard Error of the Mean|3.955|<|0.001|2-Sided|95.0|-72.128|-56.409|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633207|NCT02055976|3000424|Superiority or Other||Adjusted Mean Difference|-62.624|Standard Error of the Mean|3.993|<|0.001|2-Sided|95.0|-70.557|-54.691|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633208|NCT02055976|3000424|Superiority or Other||Adjusted Mean Difference|-47.531|Standard Error of the Mean|4.016|<|0.001|2-Sided|95.0|-55.511|-39.551|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633209|NCT02055976|3000424|Superiority or Other||Adjusted Mean Difference|-71.534|Standard Error of the Mean|3.903|<|0.001|2-Sided|95.0|-79.284|-63.784|||Mixed Models Analysis|One-sided p-values (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633210|NCT02055976|3000424|Superiority or Other||Adjusted Mean Difference|-66.754|Standard Error of the Mean|3.912|<|0.001|2-Sided|95.0|-74.523|-58.986|||Mixed Models Analysis|One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the MMRM model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633211|NCT02055976|3000424|Superiority or Other||Adjusted Mean Difference|-49.838|Standard Error of the Mean|3.775|<|0.001|2-Sided|95.0|-57.335|-42.34|||Mixed Models Analysis|One-sided p-value (adjusted for multiplicity) was derived from the MMRM model.||Adjusted mean difference and 2-sided 95% confidence interval were derived from the mixed-effect model for repeated measures (MMRM) model with fixed effects for treatment, visit, baseline value, treatment by visit interaction, and baseline by visit interaction.|
1633212|NCT02055352|3000459|Non-Inferiority or Equivalence|A change of 5-10% from baseline values is considered to be clinically important. The estimated adjusted treatment difference for budesonide 400 μg twice a day/ indacaterol 150 μg once daily minus fixed combination of fluticasone/ salmeterol 250/ 50 μg twice daily was displayed along with the associated one-sided 97.5% confidence interval. If the lower limit of this confidence interval was to the right (i.e. above) – 10 mL, then non-inferiority could be claimed.||||||0.004|||||||Mixed effects General linear model||||
1633213|NCT02055118|3000491|Superiority||Least squares mean|3.0|Standard Error of the Mean|5.12||0.5669|2-Sided|95.0|-7.3|13.3|||Mixed model repeated measures|||The Mixed model repeated measures included fixed categorical effects for treatment, visit week, treatment by visit week interaction, baseline GCA classification factor (less than or equal to [<=] 70 or >70), baseline age group (<6 years or >=6 years), treatment by baseline GCA classification factor interaction, treatment by baseline age group interaction, interaction between baseline GCA classification factor and baseline age group, genotype, and the baseline GCA score as a continuous covariate.|
1634023|NCT02037568|3002053|Superiority|||||||0.96|||||||Mixed Models Analysis||||
1633214|NCT02054897|3000503|Superiority|Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% CI for the estimated difference was below 0%.|Treatment difference|-1.43|||<|0.0001|2-Sided|95.0|-1.71|-1.15|||Mixed Models Analysis||Semaglutide 0.5 mg minus Placebo|For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 0.5 mg versus placebo, if superiority for semaglutide 1.0 mg was concluded. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|
1633215|NCT02054897|3000503|Superiority|Superiority for change in HbA1c was claimed if the upper limit of the 2-sided 95% confidence interval (CI) for the estimated difference was below 0%.|Treatment difference|-1.53|||<|0.0001|2-Sided|95.0|-1.81|-1.25|||Mixed Models Analysis||Semaglutide 1.0 mg minus Placebo|For the primary HbA1c endpoint, superiority was planned to be tested for semaglutide 1.0 mg versus placebo. The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|
1633216|NCT02054715|3000507|Other|||||||0.014|||||||Chi-squared|||Chi-square test between MP and PE. 69% of subjects that got the Multimedia Psychoeducation intervention chose to participate in a clinical trial, compared with 62% in the Print Education group|
1633217|NCT02054715|3000508|Other||Mean Difference (MP - PE)|-0.05|Standard Error of the Mean|1.4||0.9709|2-Sided|95.0|-2.79|2.69|||F-Test|||Two-sided F-Test comparing the MP and PE means.|
1633218|NCT02054715|3000509|Other||Mean Difference (MP - PE)|0.18|Standard Error of the Mean|1.57||0.9065|2-Sided|95.0|-2.89|3.26|||F-test|||Two-sided F-Test comparing the MP and PE means.|
1633219|NCT02054715|3000510|Other||Mean Difference (MP – PE)|-0.1|Standard Error of the Mean|2.0||0.9621|2-Sided|95.0|-4.1|3.9|||F-Test|||Two-sided F-Test as a statistical comparing MP and PE means.|
1633220|NCT02054702|3000511|Superiority or Other|||||||0.9716|||||||ANCOVA|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for aripiprazole.|
1633221|NCT02054702|3000511|Superiority or Other|||||||0.0392|||||||ANCOVA|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in BIS-11 item total score from baseline to week 6 for brexpiprazole.|
1633222|NCT02054702|3000512|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|The ANCOVA model, with treatment group as main effect and total score at baseline as covariate, was used for change from baseline comparisons.||Statistical analysis is mean change in SLOF total score from baseline to week 6 for aripiprazole.|
1633223|NCT02054702|3000512|Superiority or Other||||||<|0.0001|||||||ANCOVA|The analysis of covariance (ANCOVA) model with treatment group and total score at baseline as covariate was used for change from baseline comparisons.||Statistical analysis is mean change in SLOF total score from baseline to week 6 for brexpiprazole.|
1633224|NCT02054702|3000515|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in CGI-S from baseline to week 6 were observed for aripiprazole.|
1633225|NCT02054702|3000515|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in CGI-S from baseline to week 6 for brexpiprazole.|
1633226|NCT02054702|3000516|Superiority or Other|||||||0.9928|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for aripiprazole.|
1633227|NCT02054702|3000516|Superiority or Other|||||||0.8588|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of one card learning task from baseline to week 6 for brexpiprazole.|
1633228|NCT02054702|3000517|Superiority or Other|||||||0.4848|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for aripiprazole.|
1633229|NCT02054702|3000517|Superiority or Other|||||||0.8622|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of identification task from baseline to week 6 for brexpiprazole.|
1633230|NCT02054702|3000518|Superiority or Other|||||||0.2802|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for aripiprazole.|
1633231|NCT02054702|3000518|Superiority or Other|||||||0.1807|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of detection task from baseline to week 6 for brexpiprazole.|
1633232|NCT02054702|3000519|Superiority or Other|||||||0.3781|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for aripiprazole.|
1633233|NCT02054702|3000519|Superiority or Other|||||||0.842|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery score of GML from baseline to week 6 for brexpiprazole.|
1633234|NCT02054702|3000520|Superiority or Other|||||||0.2176|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.|
1633235|NCT02054702|3000520|Superiority or Other|||||||0.8759|||||||Mixed Models Analysis|Mixed model repeated measures method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis is mean change in cognitive test battery of early phase battery score from baseline to week 6 for aripiprazole.|
1633250|NCT02054338|3000559|Superiority||Hazard Ratio (HR)|1.05||||0.54|2-Sided|95.0|0.91|1.2|||Log Rank|||Kaplan-Meier curves and life tables by treatment arm to describe time-dependent parameters. Stratified Cox proportional model was used to compare the 2 treatment arms. A stratified Cox proportional hazards model and logistic regression were applied to the progression-free survival and to the tumour response, respectively.|
1633251|NCT02054156|3000562|Superiority||Rate Ratio|1.25||||0.2098|2-Sided|95.0|0.88|1.78|||Poisson Regression|||Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the Azithromycin group was 1267.73 and in the Placebo group was 1193.72.|
1633252|NCT02054156|3000562|Superiority||Rate Ratio|0.86||||0.0004|2-Sided|95.0|0.8|0.94|||Poisson Regression|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months of all participants (not per participant) in the trial was as follows: in the Azithromycin group was 1267.73 and in the Placebo group was 1193.72.|
1633253|NCT02054156|3000563|Superiority||Difference in % of Participants with AE|4.4||||0.3593|2-Sided|95.0|-3.5|12.6|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson.||
1633254|NCT02054156|3000563|Superiority||Difference in % of Participants with SAE|-2.5||||0.7531|2-Sided|95.0|-13.7|8.7|||Fisher Exact||95% confidence interval calculated using the Newcombe-Wilson method without continuity correction.||
1633255|NCT02054156|3000564|Superiority||Hazard Ratio (HR)|1.0||||0.9915|2-Sided|95.0|0.64|1.55|||Cox Proportional Hazards Model||The estimate is adjusted for age strata (>=6 months - 3 years, >3 - 6 years, >6 - 12 years, and >12 - 18 years).||
1633256|NCT02054156|3000565|Superiority||Hazard Ratio (HR)|0.56||||0.0043|2-Sided|95.0|0.37|0.83|||Cox Proportional Hazards Model||The estimate is adjusted for age strata (>=6 months - 3 years, >3 - 6 years, >6 - 12 years, and >12 - 18 years).||
1633257|NCT02054130|3000587|Superiority||Rate ratio|0.34|||<|0.001|2-Sided|95.0|0.2|0.58|||Negative bnomial regression||||
1633258|NCT02054130|3000587|Superiority||Rate ratio|0.29|||<|0.001|2-Sided|95.0|0.16|0.51|||Negative binomial regression||||
1633259|NCT02054130|3000587|Superiority||Rate ratio|0.38|||<|0.001|2-Sided|95.0|0.23|0.63|||Negative binomial regression||||
1633260|NCT02053753|3000595|Non-Inferiority or Equivalence|The 2 treatments were considered bioequivalent if the 90% CIs for the ratio of the geometric means were between 0.80 and 1.25.|Ratio of Geometric Means (CP4:CP2)|1.028|||||2-Sided|90.0|0.934|1.131|||||The ratio and confidence interval of the geometric means are based on natural log scale data converted back to the original scale.||
1633261|NCT02053753|3000596|Non-Inferiority or Equivalence|The 2 treatments were considered bioequivalent if the 90% CIs for the ratio of the geometric means were between 0.80 and 1.25.|Ratio of Geometrc Means (CP4:CP2)|1.084|||||2-Sided|90.0|0.995|1.181|||||The ratio and confidence interval of the geometric means are based on natural log scale data converted back to the original scale.||
1633262|NCT02053610|3000599|Superiority or Other||Hazard Ratio (stratified)|0.58|||<|0.0001|2-Sided|95.0|0.46|0.73|||Log Rank, Stratified|Stratified by Binet stage at Baseline.|||
1633263|NCT02053610|3000601|Superiority or Other||Hazard Ratio (HR)|0.5|||<|0.0001|2-Sided|95.0|0.41|0.61|||Log Rank, Stratified|Stratified by Binet stage at Baseline.|||
1633264|NCT02053610|3000602|Superiority or Other||Hazard Ratio (stratified)|0.76||||0.0245|2-Sided|95.0|0.6|0.97|||Log Rank, Stratified|Stratified by Binet stage at Baseline.|||
1633265|NCT02053610|3000603|Superiority or Other||Hazard Ratio (HR)|0.51|||<|0.0001|2-Sided|95.0|0.43|0.61|||Log Rank, Stratified|Stratified by Binet stage at Baseline.|||
1633266|NCT02053610|3000604|Superiority or Other||Difference in Response Rates|12.92||||0.0002|2-Sided|95.0|6.1|19.8|||Chi-squared|||Includes participants with best overall response: CR, CRi, PR or nPR.|
1633267|NCT02053610|3000605|Superiority or Other||Difference in Response Rates|13.22||||0.0001|2-Sided|95.0|6.3|20.1|||Chi-squared|||Includes participants with EOTR: CR, CRi, PR or nPR.|
1633268|NCT02053610|3000607|Superiority or Other||Hazard Ratio (HR)|0.42|||<|0.0001|2-Sided|95.0|0.33|0.54|||Log Rank, Stratified|Stratified by Binet stage at Baseline.|Stratified by Binet stage at Baseline.||
1633269|NCT02053610|3000609|Superiority or Other||Hazard Ratio (HR)|0.49|||<|0.0001|2-Sided|95.0|0.41|0.58|||Log Rank, Stratified|Stratified by Binet stage at Baseline.|||
1633270|NCT02052895|3000646|Superiority or Other||Difference of ROC-AUC|0.0317||||0.3924|2-Sided|95.0|-0.0409|0.1043|||Regression, Logistic||||
1633271|NCT02052752|3000652|Superiority or Other|||||||0.283|||||||ANCOVA|||The ANCOVA results for the primary endpoint with treatment group as a main effect and average baseline value as a covariate showed no statistically significant differences in the percentage change from baseline in swelling of the target lesions between the 3% BPO group and the vehicle control group at Day 4 for the ITT population|
1633272|NCT02052596|3000671|Non-Inferiority|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval (CI) for the difference in the percentages of subjects with anti-tetanus (anti-T) concentrations ≥ 1.0 IU/mL of the Control Group minus the GSK1437173A Group had to be < 10%.|Difference in seropositivity rate|0.01|||||2-Sided|95.0|-1.18|1.27||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for tetanus (T) antigen, one month after the vaccine dose.|
1633273|NCT02052596|3000671|Non-Inferiority|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval (CI) for the difference in the percentages of subjects with anti-diphtheria (anti-D) concentrations ≥ 1.0 IU/mL of the Control Group minus the GSK1437173A Group had to be < 10%.|Difference in seropositivity rate|-0.1|||||2-Sided|95.0|-3.03|2.85||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for diphteria (D) antigen, one month after the vaccine dose.|
1633297|NCT02048670|3000829|Superiority|||||||0.173|||||||Kruskal-Wallis|||Condition 4 - eyes open, visual surround locked, platform unlocked|
1633298|NCT02048670|3000829|Superiority|||||||0.051|||||||Kruskal-Wallis|||Condition 3 - eyes open, visual surround unlocked, platform locked|
1633274|NCT02052596|3000672|Non-Inferiority|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-PRN antibodies of the Control Group over the GSK1437173A Group had to be < 1.5.|Adjusted GMC ratio|1.27|||||2-Sided|95.0|1.02|1.58||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertactin (PRN) antigen, one month after the vaccine dose.|
1633275|NCT02052596|3000672|Non-Inferiority|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-FHA antibodies of the Control Group over the GSK1437173A Group had to be < 1.5.|Adjusted GMC ratio|1.24|||||2-Sided|95.0|1.07|1.44||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for filamentous hemagglutinin (FHA) antigen, one month after the vaccine dose.|
1633276|NCT02052596|3000672|Non-Inferiority|Criteria for non-inferiority: At one month after the first vaccine dose (Month 1), the upper limit (UL) of the 95% confidence interval for the GMC ratio for anti-PT antibodies of the Control Group over the GSK1437173A Group had to be < 1.5.|Adjusted GMC ratio|1.17|||||2-Sided|95.0|1.0|1.36||||||Demonstration of non-inferiority of the humoral immune response to Boostrix vaccine when co-administered with GSK1437173A vaccine at first vaccination dose compared to Boostrix vaccine (administered separately from GSK1437173A) for pertussis toxoid (PT), one month after the vaccine dose.|
1633277|NCT02052596|3000673|Non-Inferiority|Criteria for non-inferiority: At one month after the last vaccine dose (Month 3 or Month 5), the upper limit (UL) of the 95% confidence interval (CI) for the anti-gE antibodies GMC ratio between the Control Group and the GSK1437173A Group had to be below (<) 1.5,|Adjusted GMC ratio|1.11|||||2-Sided|95.0|1.02|1.21||||||Demonstration of non-inferiority of the humoral immune response to two doses of the GSK1437173A vaccine when Boostrix vaccine was co-administered with the first GSK1437173A vaccine dose compared to two doses of GSK1437173A vaccine (administered separately from Boostrix vaccine), one month after the last vaccine dose.|
1633278|NCT02052141|3000702|Superiority||Mean difference|-0.2|Standard Deviation|0.37||0.07|2-Sided|90.0|-0.41|-0.03|||Paired t-test||The difference between treatment B over treatment A was estimated||
1633279|NCT02052141|3000703|Superiority||Mean difference|-1.9|Standard Deviation|2.82||0.04|2-Sided|90.0|-3.31|-0.38|||Paired t-test||The difference between treatment B over treatment A was estimated.||
1633280|NCT02052141|3000704|Superiority||Mean difference|-0.7|Standard Deviation|1.06||0.05|2-Sided|90.0|-1.2|-0.11|||Paired t-test||The difference between treatment B over treatment A was estimated.||
1633281|NCT02052141|3000705|Superiority||Mean difference|-0.4|Standard Deviation|0.58||0.03|2-Sided|90.0|-0.71|-0.1|||Paired t-test||The difference between treatment B over treatment A was estimated.||
1633282|NCT02052011|3000706|Superiority or Other||Mean Difference (Final Values)|0.27|||||2-Sided|95.0|-0.08|0.62|||||||
1633283|NCT02051595|3000718|Superiority or Other||estimate (beta) from mixed model|-0.068|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|-0.098|-0.039||A priori threshold was set to p < 0.05.|Mixed Models Analysis|Analyses modeled change in vancomycin concentrations (independent variable defined by time). Analyses were adjusted for covariates.|Negative beta value indicates that vancomycin concentration decreased following cardiopulmonary bypass (CPB).||
1633284|NCT02051335|3000734|Superiority or Other||LS mean difference|2.86|Standard Error of the Mean|0.943||0.004|2-Sided|95.0|1.0|4.7||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA||||
1633285|NCT02051335|3000734|Superiority or Other||LS mean difference|0.09|Standard Error of the Mean|0.974||0.928|2-Sided|95.0|-1.9|2.0||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA||||
1633286|NCT02051335|3000734|Superiority or Other||LS mean difference|2.01|Standard Error of the Mean|0.972||0.042|2-Sided|95.0|0.1|4.0||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA||||
1633287|NCT02051335|3000734|Superiority or Other||LS mean difference|-0.84|Standard Error of the Mean|0.981||0.394|2-Sided|95.0|-2.8|1.1||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA||||
1633288|NCT02051335|3000734|Superiority or Other||LS mean difference|1.93|Standard Error of the Mean|0.992||0.057|2-Sided|95.0|-0.1|3.9||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA||||
1633289|NCT02051335|3000735|Superiority or Other||LS mean difference|0.82|Standard Error of the Mean|0.53||0.126|2-Sided|95.0|-0.2|1.9||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA||||
1633290|NCT02051335|3000735|Superiority or Other||LS mean difference|0.44|Standard Error of the Mean|0.549||0.426|2-Sided|95.0|-0.7|1.5||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA||||
1633291|NCT02051335|3000735|Superiority or Other||LS mean difference|0.12|Standard Error of the Mean|0.547||0.821|2-Sided|95.0|-1.0|1.2||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA||||
1633292|NCT02051335|3000735|Superiority or Other||LS mean difference|-0.7|Standard Error of the Mean|0.55||0.21|2-Sided|95.0|-1.8|0.4||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA||||
1633293|NCT02051335|3000735|Superiority or Other||LS mean difference|-0.31|Standard Error of the Mean|0.556||0.573|2-Sided|95.0|-1.4|0.8||P-values were obtained using an ANOVA model with sequence, period, and treatment as fixed effects and participant nested within sequence as a random effect.|ANOVA||||
1633294|NCT02049814|3000796|Non-Inferiority or Equivalence|If the upper limit of 95% CI of Least Square Mean (LS mean) of HbA1C Changes was less than 0.4%, it was considered that the non-inferiority was established.||||||0.0001|||||||Paired t-test||||
1633305|NCT02047110|3000880|Superiority or Other||Risk Difference (RD)|-2.5||||0.4174|2-Sided|90.0|-21.8|17.0||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."||
1633306|NCT02047110|3000880|Superiority or Other||Risk Difference (RD)|8.1||||0.2691|2-Sided|90.0|-10.9|25.7||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."||
1633307|NCT02047110|3000880|Superiority or Other||Risk Difference (RD)|7.5||||0.2639|2-Sided|90.0|-12.1|26.6||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 24, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."||
1633308|NCT02047110|3000881|Superiority or Other||Median estimate by Hodges−Lehmann method|-0.2||||0.3203|2-Sided|90.0|-0.8|0.4||One sided p-value from Wilcoxon rank−sum test|Wilcoxon rank−sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 180 mg minus Placebo."||
1633309|NCT02047110|3000881|Superiority or Other||Median estimate by Hodges−Lehmann method|0.3||||0.3033|2-Sided|90.0|-0.5|1.0||One sided p-value from Wilcoxon rank−sum test|Wilcoxon rank−sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 90 mg minus Placebo."||
1633310|NCT02047110|3000881|Superiority or Other||Median estimate by Hodges−Lehmann method|-0.4||||0.1241|2-Sided|90.0|-1.0|0.2||One sided p-value from Wilcoxon rank−sum test|Wilcoxon rank−sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 18 mg minus Placebo."||
1633311|NCT02047110|3000882|Superiority or Other||Risk Difference (RD)|12.5||||0.1198|2-Sided|90.0|-7.1|31.4||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."||
1633312|NCT02047110|3000882|Superiority or Other||Risk Difference (RD)|13.3||||0.1243|2-Sided|90.0|-5.9|30.5||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."||
1633313|NCT02047110|3000882|Superiority or Other||Risk Difference (RD)|25.0||||0.0092|2-Sided|90.0|5.5|43.1||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."||
1633314|NCT02047110|3000883|Superiority or Other||Risk Difference (RD)|7.5|||||2-Sided|90.0|-12.1|26.6|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.|
1633315|NCT02047110|3000883|Superiority or Other||Risk Difference (RD)|0.1|||||2-Sided|90.0|-18.3|18.3|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.|
1633316|NCT02047110|3000883|Superiority or Other||Risk Difference (RD)|0.0|||||2-Sided|90.0|-19.4|19.4|||||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|p-values are not presented as they were not meaningful; 3 treatment groups had only a single patient with partial remission.|
1633317|NCT02047110|3000884|Superiority or Other||Risk Difference (RD)|12.5||||0.0465|2-Sided|90.0|-7.1|31.4||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."||
1633318|NCT02047110|3000884|Superiority or Other||Risk Difference (RD)|18.1||||0.012|2-Sided|90.0|-0.8|35.3||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."||
1633319|NCT02047110|3000884|Superiority or Other||Risk Difference (RD)|15.0||||0.0238|2-Sided|90.0|-4.6|33.8||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the endpoint at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."||
1633320|NCT02047110|3000885|Superiority or Other||Median estimate by Hodges−Lehmann method|-0.5||||0.0101|2-Sided|90.0|-0.7|-0.1||One sided p-value from Wilcoxon rank−sum test|Wilcoxon rank−sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 180 mg minus Placebo."||
1633321|NCT02047110|3000885|Superiority or Other||Median estimate by Hodges−Lehmann method|-0.3||||0.1038|2-Sided|90.0|-0.6|0.1||One sided p-value from Wilcoxon rank−sum test|Wilcoxon rank−sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 90 mg minus Placebo."||
1633322|NCT02047110|3000885|Superiority or Other||Median estimate by Hodges−Lehmann method|-0.4||||0.0229|2-Sided|90.0|-0.7|-0.1||One sided p-value from Wilcoxon rank−sum test|Wilcoxon rank−sum test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Moses method. Difference calculated as risankizumab 18 mg minus Placebo."||
1633323|NCT02047110|3000886|Superiority or Other||Risk Difference (RD)|-2.5||||0.4243|2-Sided|90.0|-21.8|17.0||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 180 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.|
1633324|NCT02047110|3000886|Superiority or Other||Risk Difference (RD)|3.0||||0.4129|2-Sided|90.0|-15.9|20.8||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper- Pearson method. Difference calculated as risankizumab 90 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.|
1633325|NCT02047110|3000886|Superiority or Other||Risk Difference (RD)|7.5||||0.2652|2-Sided|90.0|-12.1|26.6||The Suissa-Shuster unconditional exact test was used to test the difference in the proportion of patients achieving the primary endpoint, ASAS 40 response at Week 12, between treatment groups.|Suissa-Shuster unconditional exact test||"The confidence interval for the difference in proportion between the treatment groups was obtained by the Clopper-Pearson method. Difference calculated as risankizumab 18 mg minus Placebo."|To control the type I error rate, the primary endpoint was tested in a hierarchical fixed sequence approach. The proportion of patients achieving ASAS 40 response at Week 12 was pairwise compared in the following sequence: risankizumab 180 mg vs. placebo (1.) and risankizumab 90 mg vs. placebo (2.). The significance level was 5% (1-sided). The comparison risankizumab 18 mg vs. placebo was not included in the formal testing sequence; an exploratory p-value was provided.|
1633326|NCT02046993|3000913|Superiority or Other|||||||0.204|||||||t-test, 2 sided|||comparison of mHDBP in mmHg at 6 months between Telemonitoring and Enhanced Usual Care groups|
1633327|NCT02046993|3000913|Superiority or Other|||||||0.199|||||||t-test, 2 sided|||comparison of mHSBP in mmHg between Telemonitoring groups and Enhanced Usual Care groups at 6 months|
1633328|NCT02046993|3000914|Superiority or Other|||||||0.204|||||||t-test, 2 sided|||comparison of mHDBP in mmHg between Telemonitoring and Enhanced Usual Care groups at 3 months|
1633329|NCT02046993|3000914|Superiority or Other|||||||0.138|||||||t-test, 2 sided|||comparison of mHSBP at 3 months between smartphone based telemonitoring group and control group on enhanced usual care|
1633330|NCT02046993|3000915|Superiority or Other|||||||0.902|||||||t-test, 2 sided|||comparison of baseline mHDBP in mmHg between Telemonitoring and Enhanced Usual Care groups|
1633331|NCT02046993|3000915|Superiority or Other|||||||0.532|||||||t-test, 2 sided|||comparison of baseline mHSBP in mmHg between Telemonitoring and Enhanced Usual Care groups|
1633332|NCT02046993|3000916|Superiority or Other|||||||0.325|||||||t-test, 2 sided|||Comparison of SEMCD at 6 months between telemonitoring group and enhanced usual care group|
1633333|NCT02046993|3000916|Superiority or Other|||||||0.512|||||||t-test, 2 sided|||Comparison of SEMCD at 3 months between telemonitoring group and enhanced usual care|
1633334|NCT02046993|3000916|Superiority or Other|||||||0.819|||||||t-test, 2 sided|||Comparison of baselline SEMCD between telemonitoring group and enhanced usual care|
1633335|NCT02046993|3000917|Superiority or Other|||||||0.967|||||||t-test, 2 sided|||Comparison of difference in mean clinic diastolic BP readings mCDBP between control and intervention at 6 months from baseline|
1633336|NCT02046993|3000917|Superiority or Other|||||||0.495|||||||t-test, 2 sided|||Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 6 months from baseline|
1633337|NCT02046993|3000917|Superiority or Other|||||||0.14|||||||t-test, 2 sided|||Comparison of difference of mean clinic diastolic BP mCDBP readings between control and intervention at 3 months from baseline|
1633338|NCT02046993|3000917|Superiority or Other|||||||0.476|||||||t-test, 2 sided|||Comparison of difference of mean clinic systolic BP readings mCSBP between control and intervention at 3 months from baseline|
1633339|NCT02046993|3000917|Superiority or Other|||||||0.865|||||||t-test, 2 sided|||Comparison of baseline mean clinic diastolic BP mCDBP readings between control and intervention|
1633340|NCT02046993|3000917|Superiority or Other|||||||0.813|||||||t-test, 2 sided|||Comparison of baseline mean clinic systolic BP mCSBP readings between control and intervention|
1633341|NCT02046993|3000918|Superiority or Other|||||||0.009|||||||McNemar|||Change in proportion of patients doing HBPM at 6 months from baseline within control group|
1633342|NCT02046993|3000918|Superiority or Other|||||||0.002|||||||McNemar|||Change in the proportion of patients doing HBPM at 3 months from baseline within the control group|
1633343|NCT02046993|3000918|Superiority or Other|||||||0.06|||||||McNemar|||comparison in percentage of patients doing Home BP monitoring at 6th month from baseline within intervention group|
1633781|NCT02038881|3001869|Other||Diff in SC rate (Gr 1 - Gr 2) at Week 6|0.0|||||2-Sided|95.0|-16.8|16.3|||||||
1633346|NCT02046980|3000919|Superiority or Other||Odds Ratio (OR)|2.67||||0.0366|2-Sided|95.0|1.25|5.67|||Regression, Logistic||||
1633347|NCT02046980|3000919|Superiority or Other||Odds Ratio (OR)|3.39||||0.02839|2-Sided|95.0|1.58|7.31|||Regression, Logistic||||
1633348|NCT02046369|3000999|Superiority||LS mean differnce (SE)|-0.44|Standard Error of the Mean|0.112|<|0.0001|2-Sided|95.0|-0.66|-0.22||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).|LS mean differnece (SE)||||
1633349|NCT02046369|3001000|Superiority||LS mean differnce (SE)|-0.7|Standard Error of the Mean|0.77||0.3715|2-Sided|95.0|-2.2|0.8|||ANCOVA|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).|
1633350|NCT02046369|3001001|Superiority||LS mean differnce (SE)|4.7|Standard Error of the Mean|1.19|<|0.0001|2-Sided|95.0|2.4|7.0|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).|
1633351|NCT02046369|3001002|Superiority||LS mean differnce (SE)|3.9|Standard Error of the Mean|1.35||0.0044|2-Sided|95.0|1.2|6.5|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).|
1633352|NCT02046369|3001003|Superiority||LS mean differnce (SE)|-1.1|Standard Error of the Mean|0.54||0.0385|2-Sided|95.0|-2.2|-0.1|||LS mean differnece (SE)|||LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).|
1633353|NCT02046369|3001004|Superiority|The primary efficacy endpoint (the change from baseline in CDRS-R total score at Week 6)will be analyzed using a likelihood-based mixed model for repeated measures (MMRM).The response (dependent) variable is the change from baseline in CDRS-R total score assessed weekly (Weeks 1 to 6).The MMRM model includes fixed effects terms for treatment, visit (as a categorical variable), pooled country, age stratum (stratification factor, CDRS-R total score at baseline, and treatment-by-visit interaction.|LS mean differnce (SE)|-5.7|Standard Error of the Mean|1.39|<|0.0001|2-Sided|95.0|-8.4|-3.0|||LS mean differnece (SE)|||A mean difference in change from Baseline in CDRS-R total score of 5.0 units was assumed for the lurasidone 20-80 mg/day arm over the placebo arm, and a common standard deviation of 14.2 units (effect size=0.35), a sample size of 145 subjects per treatment arm was calculated to yield a power of 85%. With an expected attrition rate of 15%, approximately 170 subjects per treatment arm (340 in total) were to be randomized in a 1:1 ratio .|
1633354|NCT02046200|3001016|Superiority or Other|||||||0.99|||||||ANOVA||||
1633355|NCT02046200|3001017|Superiority or Other|||||||0.09|||||||ANOVA||||
1633356|NCT02046200|3001018|Superiority or Other|||||||0.21|||||||ANOVA||||
1633357|NCT02046200|3001019|Superiority or Other|||||||0.06|||||||ANOVA||||
1633358|NCT02046200|3001020|Superiority or Other|||||||0.43|||||||ANOVA||||
1633359|NCT02046200|3001021|Superiority or Other|||||||0.95|||||||ANOVA||||
1633360|NCT02046200|3001022|Superiority or Other|||||||0.93|||||||ANOVA||||
1633361|NCT02046200|3001023|Superiority or Other|||||||0.7617|||||||ANOVA||||
1633362|NCT02046200|3001024|Superiority or Other|||||||0.1597|||||||ANOVA||||
1633363|NCT02046200|3001025|Superiority or Other|||||||0.0342|||||||ANOVA||||
1633364|NCT02046200|3001026|Superiority or Other|||||||0.0563|||||||ANOVA||||
1633365|NCT02046070|3001086|Other|||||||0.9688|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR+PR rate=60% obtained using the one-sided Chi-Square test with alpha=0.10.|
1633366|NCT02046070|3001087|Other|||||||0.6757|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.|
1633367|NCT02046070|3001087|Other|||||||0.4859|||||||Chi-squared|||P-value tests the null hypothesis: CR+VGPR rate=27% in treatment arms obtained using the one-sided Chi-Square test with alpha=0.10.|
1633368|NCT02046005|3001088|Superiority||Risk Ratio (RR)|1.23||||0.043|2-Sided|95.0|1.01|1.51||We compared the PRE-RA group (PRE-RA arm and PRE-RA Plus arm combined) to the Comparison arm for the primary composite outcome at the 3 primary post-intervention time points using generalized estimating equations (GEE).|generalized estimating equations||PRE-RA group (combined PRE-RA arm and PRE-RA Plus arm) compared to Comparison arm (reference)|"In the primary analysis, we combined the PRE-RA and PRE-RA Plus arms into a single PRE-RA group and compared it to the Comparison arm (aka General Rheumatoid Arthritis Education)"|
1633369|NCT02045979|3001090|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|94.04|||||2-Sided|90.0|86.01|102.82|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633370|NCT02045979|3001090|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|101.36|||||2-Sided|90.0|92.51|111.05|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633371|NCT02045979|3001090|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|108.7|||||2-Sided|90.0|98.54|119.9|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633372|NCT02045979|3001091|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|95.37|||||2-Sided|90.0|89.53|101.6|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633553|NCT02043678|3001407|Superiority||Hazard Ratio (HR)|1.195||||0.128|2-Sided|95.0|0.95|1.505|||Cox Proportional Hazards model||||
1633554|NCT02043678|3001408|Superiority||Hazard Ratio (HR)|1.122||||0.2636|2-Sided|95.0|0.917|1.374|||Cox Proportional Hazards Model||||
1633373|NCT02045979|3001091|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|100.94|||||2-Sided|90.0|94.24|108.12|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633374|NCT02045979|3001091|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|106.57|||||2-Sided|90.0|99.07|114.63|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633375|NCT02045979|3001092|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.02|||||2-Sided|90.0|92.07|102.24|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633376|NCT02045979|3001092|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|100.16|||||2-Sided|90.0|94.37|106.29|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633377|NCT02045979|3001092|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|103.68|||||2-Sided|90.0|97.47|110.29|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633378|NCT02045979|3001093|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.01|||||2-Sided|90.0|93.15|103.11|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633379|NCT02045979|3001093|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.83|||||2-Sided|90.0|93.27|104.72|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633380|NCT02045979|3001093|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|101.23|||||2-Sided|90.0|95.45|107.36|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633381|NCT02045979|3001094|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.97|||||2-Sided|90.0|92.58|103.68|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633382|NCT02045979|3001094|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|97.19|||||2-Sided|90.0|91.39|103.35|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633383|NCT02045979|3001094|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|99.61|||||2-Sided|90.0|93.66|105.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633384|NCT02045979|3001095|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.11|||||2-Sided|90.0|91.42|105.27|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633385|NCT02045979|3001095|Non-Inferiority or Equivalence|No formal testing; two-sided 90% CI for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|96.05|||||2-Sided|90.0|89.27|103.36|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633386|NCT02045979|3001095|Non-Inferiority or Equivalence|No formal testing; two-sided 90% Confidence Interval (CI) for the ratio of adjusted geometric means was calculated.|ratio of the geometric means|98.3|||||2-Sided|90.0|91.54|105.55|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633387|NCT02045979|3001096|Non-Inferiority or Equivalence|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|95.93|||||2-Sided|90.0|90.83|101.33|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633388|NCT02045979|3001096|Non-Inferiority or Equivalence|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|96.39|||||2-Sided|90.0|91.06|102.03|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633389|NCT02045979|3001096|Non-Inferiority or Equivalence|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|100.85|||||2-Sided|90.0|95.15|106.88|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633390|NCT02045979|3001097|Non-Inferiority or Equivalence|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|93.66|||||2-Sided|90.0|86.76|101.11|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633391|NCT02045979|3001097|Non-Inferiority or Equivalence|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|99.93|||||2-Sided|90.0|92.15|108.37|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633392|NCT02045979|3001097|Non-Inferiority or Equivalence|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|107.32|||||2-Sided|90.0|98.49|116.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633393|NCT02045979|3001098|Non-Inferiority or Equivalence|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|94.02|||||2-Sided|90.0|86.01|102.78|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633394|NCT02045979|3001098|Non-Inferiority or Equivalence|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 %.|ratio of the geometric means|101.27|||||2-Sided|90.0|92.45|110.94|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633395|NCT02045979|3001098|Non-Inferiority or Equivalence|PK similarity of the two treatments was to be concluded if the 90% CI for the ratio of adjusted geometric means was within 80.00 - 125.00 percent (%).|ratio of the geometric means|108.62|||||2-Sided|90.0|98.5|119.79|||||An analysis of covariance (ANCOVA) model on the logarithmic scale with fixed effects for treatment and trial site as well as age (as recorded at the time of informed consent) and body weight (as recorded at baseline) as continuous covariates.||
1633396|NCT02045875|3001100|Other||correlation coefficient|-0.508|||||2-Sided||||||||correlation of asthma control and adherence||
1633397|NCT02045875|3001101|Superiority|||||||0.046||||||Effect of interaction of time and treatment group|ANOVA||||
1633398|NCT02045862|3001103|Superiority||Odds Ratio (OR)|1.43||||0.012|2-Sided|95.0|1.08|1.89|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.|
1633399|NCT02045862|3001103|Superiority||Odds Ratio (OR)|1.76|||<|0.001|2-Sided|95.0|1.33|2.34|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.|
1633400|NCT02045862|3001104|Superiority||Odds Ratio (OR)|1.58||||0.001|2-Sided|95.0|1.19|2.09|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.|
1633401|NCT02045862|3001104|Superiority||Odds Ratio (OR)|1.86|||<|0.001|2-Sided|95.0|1.4|2.46|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.|
1633402|NCT02045862|3001105|Superiority||Odds Ratio (OR)|1.4||||0.019|2-Sided|95.0|1.06|1.86|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.|
1633403|NCT02045862|3001105|Superiority||Odds Ratio (OR)|1.7|||<|0.001|2-Sided|95.0|1.28|2.26|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.|
1633404|NCT02045862|3001106|Superiority||Odds Ratio (OR)|1.59||||0.001|2-Sided|95.0|1.2|2.09|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.|
1633405|NCT02045862|3001106|Superiority||Odds Ratio (OR)|1.93|||<|0.001|2-Sided|95.0|1.46|2.54|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.|
1633555|NCT02043509|3001416|Superiority|||||||0.118|||||||Mann–Whitney U-test||||
1633556|NCT02043509|3001417|Superiority||Adjusted odds ratio|3.28|||||2-Sided|95.0|0.9|17.36|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.||
1633406|NCT02045862|3001107|Superiority||Odds Ratio (OR)|1.79|||<|0.001|2-Sided|95.0|1.35|2.36|||Regression, Logistic|||Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.|
1633407|NCT02045862|3001107|Superiority||Odds Ratio (OR)|1.99|||<|0.001|2-Sided|95.0|1.5|2.62|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.|
1633408|NCT02045862|3001108|Superiority||Odds Ratio (OR)|1.62|||<|0.001|2-Sided|95.0|1.22|2.16|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.|
1633409|NCT02045862|3001108|Superiority||Odds Ratio (OR)|1.69|||<|0.001|2-Sided|95.0|1.26|2.25|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.|
1633410|NCT02045862|3001109|Superiority||Odds Ratio (OR)|1.29||||0.109|2-Sided|95.0|0.94|1.77|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.|
1633411|NCT02045862|3001109|Superiority||Odds Ratio (OR)|1.68|||<|0.001|2-Sided|95.0|1.24|2.29|||Regression, Logistic|||Odds ratio is from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.|
1633412|NCT02045862|3001110|Superiority||Odds Ratio (OR)|1.48||||0.006|2-Sided|95.0|1.12|1.95|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1633413|NCT02045862|3001110|Superiority||Odds Ratio (OR)|1.55||||0.002|2-Sided|95.0|1.18|2.03|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1633414|NCT02045862|3001111|Superiority||Odds Ratio (OR)|1.23||||0.133|2-Sided|95.0|0.94|1.62|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.|
1633415|NCT02045862|3001111|Superiority||Odds Ratio (OR)|1.67|||<|0.001|2-Sided|95.0|1.26|2.19|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.|
1633416|NCT02045862|3001112|Superiority||Odds Ratio (OR)|1.44||||0.019|2-Sided|95.0|1.06|1.95|||Regression, Logistic|||Odds ratio wa from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.|
1633417|NCT02045862|3001112|Superiority||Odds Ratio (OR)|1.8|||<|0.001|2-Sided|95.0|1.34|2.41|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.|
1633418|NCT02045862|3001113|Superiority||Odds Ratio (OR)|1.44||||0.014|2-Sided|95.0|1.08|1.92|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.|
1633419|NCT02045862|3001113|Superiority||Odds Ratio (OR)|1.82|||<|0.001|2-Sided|95.0|1.36|2.43|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.|
1633420|NCT02045862|3001114|Superiority||Odds Ratio (OR)|1.87|||<|0.001|2-Sided|95.0|1.37|2.57|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.|
1633421|NCT02045862|3001114|Superiority||Odds Ratio (OR)|2.03|||<|0.001|2-Sided|95.0|1.49|2.78|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.|
1633422|NCT02045862|3001115|Superiority||Odds Ratio (OR)|1.27||||0.08|2-Sided|95.0|0.97|1.67|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.|
1633423|NCT02045862|3001115|Superiority||Odds Ratio (OR)|1.65|||<|0.001|2-Sided|95.0|1.26|2.15|||Regression, Logistic|||Odds ratio was from a logistic regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.|
1633424|NCT02045862|3001127|Superiority||Least Squares Mean Difference|-0.2|Standard Error of the Mean|0.08||0.011|2-Sided|95.0|-0.36|-0.05|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633557|NCT02043509|3001418|Superiority||Adjusted odds ratio|3.16|||||2-Sided|95.0|1.14|10.69|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.||
1633425|NCT02045862|3001127|Superiority||Least Squares Mean Difference|-0.32|Standard Error of the Mean|0.08|<|0.001|2-Sided|95.0|-0.47|-0.16|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633426|NCT02045862|3001129|Superiority||Least Squares Mean Difference|1.03|Standard Error of the Mean|0.97||0.287|2-Sided|95.0|-0.87|2.93|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633427|NCT02045862|3001129|Superiority||Least Squares Mean Difference|2.68|Standard Error of the Mean|0.98||0.006|2-Sided|95.0|0.77|4.59|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633428|NCT02045862|3001130|Superiority||Least Squares Mean Difference|3.27|Standard Error of the Mean|1.35||0.016|2-Sided|95.0|0.62|5.93|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633429|NCT02045862|3001130|Superiority||Least Squares Mean Difference|5.15|Standard Error of the Mean|1.36|<|0.001|2-Sided|95.0|2.47|7.83|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633430|NCT02045862|3001131|Superiority||Least Squares Mean Difference|3.78|Standard Error of the Mean|1.2||0.002|2-Sided|95.0|1.43|6.13|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633431|NCT02045862|3001131|Superiority||Least Squares Mean Difference|5.01|Standard Error of the Mean|1.21|<|0.001|2-Sided|95.0|2.65|7.38|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633432|NCT02045862|3001132|Superiority||Least Squares Mean Difference|3.01|Standard Error of the Mean|1.32||0.022|2-Sided|95.0|0.43|5.6|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633433|NCT02045862|3001132|Superiority||Least Squares Mean Difference|5.6|Standard Error of the Mean|1.33|<|0.001|2-Sided|95.0|2.99|8.2|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633434|NCT02045862|3001133|Superiority||Least Squares Mean Difference|2.86|Standard Error of the Mean|1.11||0.01|2-Sided|95.0|0.68|5.04|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633435|NCT02045862|3001133|Superiority||Least Squares Mean Difference|4.76|Standard Error of the Mean|1.12|<|0.001|2-Sided|95.0|2.56|6.96|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633436|NCT02045862|3001135|Superiority||Least Squares Mean Difference|-1.68|Standard Error of the Mean|0.93||0.072|2-Sided|95.0|-3.52|0.15|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633437|NCT02045862|3001135|Superiority||Least Squares Mean Difference|-2.98|Standard Error of the Mean|0.92||0.001|2-Sided|95.0|-4.78|-1.18|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633438|NCT02045862|3001136|Superiority||Rate Ratio|0.76|Standard Error of the Mean|0.14||0.044|2-Sided|95.0|0.58|0.99|||Negative Binomial Regression|||Rate ratio vs. Solifenacin 5 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.|
1633439|NCT02045862|3001136|Superiority||Rate Ratio|0.58|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|0.45|0.76|||Negative Binomial Regression|||Rate ratio vs. Mirabegron 50 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.|
1633440|NCT02045862|3001137|Superiority||Least Squares Mean Difference|-0.28|Standard Error of the Mean|0.14||0.039|2-Sided|95.0|-0.55|-0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633441|NCT02045862|3001137|Superiority||Least Squares Mean Difference|-0.42|Standard Error of the Mean|0.13||0.002|2-Sided|95.0|-0.69|-0.16|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633442|NCT02045862|3001138|Superiority||Least Squares Mean Difference|-0.7|Standard Error of the Mean|0.35||0.048|2-Sided|95.0|-1.39|-0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633443|NCT02045862|3001138|Superiority||Least Squares Mean Difference|-0.67|Standard Error of the Mean|0.35||0.055|2-Sided|95.0|-1.34|0.01|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633444|NCT02045862|3001139|Superiority||Rate Ratio|0.92|Standard Error of the Mean|0.06||0.131||95.0|0.82|1.03|||Negative Binomial Regression|||Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day as the offset variable.|
1633445|NCT02045862|3001139|Superiority||Rate Ratio|0.9|Standard Error of the Mean|0.06||0.067|2-Sided|95.0|0.81|1.01|||Negative Binomial Regression|||Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable|
1633446|NCT02045862|3001140|Superiority||Least Squares Mean Difference|-0.09|Standard Error of the Mean|0.05||0.068|2-Sided|95.0|-0.19|0.01|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633447|NCT02045862|3001140|Superiority||Least Squares Mean Difference|-0.09|Standard Error of the Mean|0.05||0.059|2-Sided|95.0|-0.19|0.0|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633448|NCT02045862|3001141|Superiority||Least Squares Mean Difference|-0.39|Standard Error of the Mean|0.19||0.036|2-Sided|95.0|-0.76|-0.03|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633449|NCT02045862|3001141|Superiority||Least Squares Mean Difference|-0.73|Standard Error of the Mean|0.19|<|0.001|2-Sided|95.0|-1.1|-0.37|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633558|NCT02043509|3001419|Superiority||Adjusted odds ratio|2.11|||||2-Sided|95.0|0.89|5.46|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.||
1633782|NCT02038881|3001869|Other||Diff in SC rate (Gr 1 - Gr 2) at Week 4|-9.6|||||2-Sided|95.0|-38.4|20.3|||||||
1633450|NCT02045862|3001143|Superiority||Least Squares Mean Difference|-0.4|Standard Error of the Mean|0.19||0.037|2-Sided|95.0|-0.77|-0.02|||ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.|
1633451|NCT02045862|3001143|Superiority||Least Squares Mean Difference|-0.78|Standard Error of the Mean|0.19|<|0.001|2-Sided|95.0|-1.16|-0.41|||ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.|
1633452|NCT02045862|3001144|Superiority||Odds Ratio (OR)|1.37||||0.007|2-Sided|95.0|1.09|1.73|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1633453|NCT02045862|3001144|Superiority||Odds Ratio (OR)|1.44||||0.002|2-Sided|95.0|1.14|1.8|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1633454|NCT02045862|3001146|Superiority||Stratified Rank ANCOVA|-0.93|Standard Error of the Mean|0.78||0.006|2-Sided|95.0|-2.47|0.61||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633455|NCT02045862|3001146|Superiority||Least Squares Mean Difference|-2.98|Standard Error of the Mean|0.78|<|0.001|2-Sided|95.0|-4.51|-1.46||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633456|NCT02045862|3001147|Superiority||Rate Ratio|0.75|Standard Error of the Mean|0.13||0.023|2-Sided|95.0|0.58|0.96|||Negative Binomial Regression|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day at EoT as the offset variable|
1633457|NCT02045862|3001147|Superiority||Rate Ratio|0.62|Standard Error of the Mean|0.13|<|0.001|2-Sided|95.0|0.48|0.79|||Negative Binomial Regression|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days at EoT as the offset variable|
1633458|NCT02045862|3001148|Superiority||Least Squares Mean Difference|-0.13|Standard Error of the Mean|0.11||0.009|2-Sided|95.0|-0.36|0.09||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate|
1633459|NCT02045862|3001148|Superiority||Least Squares Mean Difference|-0.43|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|-0.65|-0.21||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633460|NCT02045862|3001149|Superiority||Odds Ratio (OR)|1.45||||0.002|2-Sided|95.0|1.14|1.85|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.|
1633461|NCT02045862|3001149|Superiority||Odds Ratio (OR)|1.61|||<|0.001|2-Sided|95.0|1.26|2.05|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.|
1633643|NCT02043301|3001461|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|79.09|||||2-Sided|90.0|60.883|102.735|||||||
1633462|NCT02045862|3001150|Superiority||Odds Ratio (OR)|1.38||||0.009|2-Sided|95.0|1.08|1.75|||Overdispersed Binomial Regression|||Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate.|
1633463|NCT02045862|3001150|Superiority||Odds Ratio (OR)|1.6|||<|0.001|2-Sided|95.0|1.26|2.01|||Overdispersed Binomial Regression|||Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate|
1633464|NCT02045862|3001151|Superiority||Least Squares Mean Difference|-0.93|Standard Error of the Mean|0.84|<|0.001|2-Sided|95.0|-2.57|0.72||The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633465|NCT02045862|3001151|Superiority||Least Squares Mean Difference|-3.12|Standard Error of the Mean|0.83|<|0.001|2-Sided|95.0|-4.76|-1.49||The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633466|NCT02045862|3001152|Superiority||Rate Ratio|0.77|Standard Error of the Mean|0.12||0.029|2-Sided|95.0|0.61|0.97|||Mixed Effects Poisson-Negative Binomial|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.|
1633467|NCT02045862|3001152|Superiority||Rate Ratio|0.67|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|0.54|0.84|||Mixed Effects Poisson-Negative Binomial|||Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.|
1633468|NCT02045862|3001154|Superiority||Least Squares Mean Difference|0.59|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|0.32|0.86|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633469|NCT02045862|3001154|Superiority||Least Squares Mean Difference|0.55|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|0.28|0.82|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633470|NCT02045862|3001155|Superiority||Least Squares Mean Difference|-4.6|Standard Error of the Mean|1.27|<|0.001|2-Sided|95.0|-7.09|-2.12|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633471|NCT02045862|3001155|Superiority||Least Squares Mean Difference|-7.55|Standard Error of the Mean|1.27|<|0.001|2-Sided|95.0|-10.05|-5.05|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633472|NCT02045862|3001156|Superiority||Least Squares Mean Difference|12.77|Standard Error of the Mean|3.47|<|0.001|2-Sided|95.0|5.98|19.57|||ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633473|NCT02045862|3001156|Superiority||Least Squares Mean Difference|15.84|Standard Error of the Mean|3.49|<|0.001|2-Sided|95.0|8.99|22.69|||ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633559|NCT02043509|3001420|Superiority||Adjusted odds ratio|1.67|||||2-Sided|95.0|0.72|4.03|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.||
1633474|NCT02045862|3001157|Superiority||Least Squares Mean Difference|-0.42|Standard Error of the Mean|0.15||0.004|2-Sided|95.0|-0.71|-0.13||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.|ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633475|NCT02045862|3001157|Superiority||Least Squares Mean Difference|-0.48|Standard Error of the Mean|0.15|<|0.001|2-Sided|95.0|-0.77|-0.2||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.|ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633476|NCT02045862|3001158|Superiority||Least Squares Mean Difference|-0.13|Standard Error of the Mean|0.12||0.002|2-Sided|95.0|-0.37|0.11||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633477|NCT02045862|3001158|Superiority||Least Squares Mean Difference|-0.45|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|-0.69|-0.21||The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.|Stratified Rank ANCOVA|||Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.|
1633478|NCT02045836|3001168|Non-Inferiority|Non Inferiority criterion used: UL of the 95% CI for the anti-gE antibodies GMC ratio between the Control group and the Co-Ad group had to be below 1.5|Adjusted GMC|1.02|||||2-Sided|95.0|0.93|1.11|||||Adjusted ratios of GMCs between groups (Control group and Co-Ad group)|Adjusted ratios of GMCs between groups (Control group and Co-Ad group) for anti-gE antibody ELISA concentrations|
1633479|NCT02045836|3001169|Non-Inferiority|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.89|||||2-Sided|95.0|0.7|1.12|||||Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-23F|
1633480|NCT02045836|3001169|Non-Inferiority|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.03|||||2-Sided|95.0|0.84|1.25|||||Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19F|
1633481|NCT02045836|3001169|Non-Inferiority|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.15|||||2-Sided|95.0|0.95|1.4|||||Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-19A|
1633482|NCT02045836|3001169|Non-Inferiority|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.95|||||2-Sided|95.0|0.77|1.16|||||Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-18C|
1633483|NCT02045836|3001169|Non-Inferiority|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.97|||||2-Sided|95.0|0.81|1.18|||||Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-14|
1633484|NCT02045836|3001169|Non-Inferiority|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.97|||||2-Sided|95.0|0.79|1.19|||||Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-9V|
1633485|NCT02045836|3001169|Non-Inferiority|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.07|||||2-Sided|95.0|0.89|1.29|||||Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-7F|
1633486|NCT02045836|3001169|Non-Inferiority|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.92|||||2-Sided|95.0|0.73|1.16|||||Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-6B|
1633487|NCT02045836|3001169|Non-Inferiority|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.96|||||2-Sided|95.0|0.75|1.21|||||Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-5|
1633642|NCT02043301|3001461|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|91.15|||||2-Sided|90.0|70.269|118.248|||||||
1633488|NCT02045836|3001169|Non-Inferiority|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.13|||||2-Sided|95.0|0.92|1.4|||||Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-4|
1633489|NCT02045836|3001169|Non-Inferiority|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|0.96|||||2-Sided|95.0|0.8|1.16|||||Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-3|
1633490|NCT02045836|3001169|Non-Inferiority|Non Inferiority criterion used: Upper Limit (UL) of the 95% CI for each individual pneumococcal conjugate serotype Opsonophagocytic Assay (OPA) GMT ratio of the Control group over the Co-Ad group had to be below 2.|Adjusted GMT|1.03|||||2-Sided|95.0|0.81|1.31|||||Adjusted GMT ratio (Control group / Co-Ad group)|Adjusted ratios of GMTs between groups (Control group and Co-Ad group) for MOPA-1.|
1633491|NCT02044874|3001288|Superiority or Other||Difference in LS Means|-0.63||||0.0217|2-Sided|95.0|-1.17|-0.09|||mixed effects repeated measures||||
1633492|NCT02044874|3001288|Superiority or Other||Difference in LS Means|-0.34||||0.2268|2-Sided|95.0|-0.89|0.21|||mixed effects repeated measures||||
1633493|NCT02044874|3001288|Superiority or Other||Difference in LS Means|-0.97||||0.0004|2-Sided|95.0|-1.51|-0.43|||Mixed-effects repeated measures||||
1633494|NCT02044874|3001289|Superiority or Other||Odds Ratio (OR)|1.6||||0.0868|2-Sided|95.0|0.93|2.72|||Regression, Logistic||||
1633495|NCT02044874|3001289|Superiority or Other||Odds Ratio (OR)|1.2||||0.545|2-Sided|95.0|0.66|2.18|||Regression, Logistic||||
1633496|NCT02044874|3001289|Superiority or Other||Odds Ratio (OR)|1.92||||0.0219|2-Sided|95.0|1.1|3.35|||Regression, Logistic||||
1633497|NCT02044874|3001290|Superiority or Other||Odds Ratio (OR)|1.81||||0.0556|2-Sided|95.0|0.99|3.31|||Regression, Logistic||||
1633498|NCT02044874|3001290|Superiority or Other||Odds Ratio (OR)|1.06||||0.8628|2-Sided|95.0|0.54|2.09|||Regression, Logistic||||
1633499|NCT02044874|3001290|Superiority or Other||Odds Ratio (OR)|1.92||||0.0379|2-Sided|95.0|1.04|3.55|||Regression, Logistic||||
1633500|NCT02044874|3001291|Superiority or Other||Odds Ratio (OR)|1.6||||0.3438|2-Sided|95.0|0.61|4.21|||Regression, Logistic||||
1633501|NCT02044874|3001291|Superiority or Other||Odds Ratio (OR)|1.78||||0.365|2-Sided|95.0|0.51|6.17|||Regression, Logistic||||
1633502|NCT02044874|3001291|Superiority or Other||Odds Ratio (OR)|2.84||||0.0784|2-Sided|95.0|0.89|9.08|||Regression, Logistic||||
1633503|NCT02044874|3001292|Superiority or Other||Odds Ratio (OR)|1.89||||0.0477|2-Sided|95.0|1.01|3.56|||Regression, Logistic||||
1633504|NCT02044874|3001292|Superiority or Other||Odds Ratio (OR)|1.6||||0.2427|2-Sided|95.0|0.73|3.51|||Regression, Logistic||||
1633505|NCT02044874|3001292|Superiority or Other||Odds Ratio (OR)|3.02||||0.0027|2-Sided|95.0|1.47|6.22|||Regression, Logistic||||
1633506|NCT02044458|3001318|Superiority or Other|||||||0.57|||||||Chi-squared||||
1633507|NCT02044458|3001319|Superiority or Other|||||||0.38|||||||t-test, 2 sided||||
1633508|NCT02044458|3001320|Superiority or Other|||||||0.7|||||||t-test, 2 sided||||
1633509|NCT02044393|3001327|Non-Inferiority or Equivalence|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|88.19|Standard Error of the Mean|20.7|||2-Sided|90.0|78.6|98.95|||||ratio of IT+BI 691751 to BI 691751 treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of IT+BI 691751 to BI 691751 treatment (in whole blood)|
1633510|NCT02044393|3001327|Non-Inferiority or Equivalence|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|74.86|Standard Error of the Mean|32.4|||2-Sided|90.0|62.946|89.035|||||ratio of IT+BI 691751 to BI 691751 treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of IT+BI 691751 to BI 691751 treatment (in plasma)|
1633511|NCT02044393|3001328|Non-Inferiority or Equivalence|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|93.54|Standard Error of the Mean|15.1|||2-Sided|90.0|86.142|101.57|||||ratio of test to reference treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of test to reference treatment (in whole blood)|
1633512|NCT02044393|3001328|Non-Inferiority or Equivalence|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|95.59|Standard Error of the Mean|23.5|||2-Sided|90.0|84.195|108.537|||||ratio of test to reference treatment. The standard error of the mean actually is the geometric coefficient of variance.|gMean ratio of test to reference treatment (in plasma)|
1633513|NCT02044393|3001329|Non-Inferiority or Equivalence|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|86.35|Standard Error of the Mean|18.6|||2-Sided|90.0|78.04|95.56|||||"ratio of IT+BI 691751 to BI 691751 treatment. Estimated value and its confidence interval (CI) are in percentage unit.~The standard error of the mean actually is the geometric coefficient of variance."|gMean ratio of IT+BI 691751 to BI 691751 treatment (in whole blood)|
1633524|NCT02044094|3001366|Non-Inferiority|Blockade was achieved if the upper bound of the 95% confidence interval was <= the non-inferiority margin of 11.|LSM difference|3.316|Standard Error of the Mean|2.367|||2-Sided|95.0|-1.425|8.025|||||Hydromorphone - Placebo|"Week 4~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."|
1633514|NCT02044393|3001329|Non-Inferiority or Equivalence|"90% confidence interval for gMean ratio of IT+BI 691751 to BI 69175 treatment was provided.~The ANOVA model included the fixed effects 'sequence', 'period' and 'treatment' and as a random effect 'subject within sequence' as source of variation."|gMean ratio|74.07|Standard Error of the Mean|32.1|||2-Sided|90.0|62.371|87.959|||||"ratio of IT+BI 691751 to BI 691751 treatment. Estimated value and its confidence interval (CI) are in percentage unit.~The standard error of the mean actually is the geometric coefficient of variance."|gMean ratio of IT+BI 691751 to BI 69175 treatment (in plasma)|
1633515|NCT02044367|3001333|Non-Inferiority or Equivalence|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|144.8|Standard Deviation|32.0|||2-Sided|90.0|130.853|160.242|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.|
1633516|NCT02044367|3001333|Non-Inferiority or Equivalence|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|147.8|Standard Deviation|32.4|||2-Sided|90.0|133.384|163.779|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.|
1633517|NCT02044367|3001334|Non-Inferiority or Equivalence|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|132.0|Standard Deviation|28.0|||2-Sided|90.0|120.714|144.342|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.|
1633518|NCT02044367|3001334|Non-Inferiority or Equivalence|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|137.61|Standard Deviation|26.5|||2-Sided|90.0|126.418|149.797|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.|
1633519|NCT02044367|3001335|Non-Inferiority or Equivalence|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|141.06|Standard Deviation|31.5|||2-Sided|90.0|127.644|155.876|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.|
1633520|NCT02044367|3001335|Non-Inferiority or Equivalence|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|146.16|Standard Deviation|31.6|||2-Sided|90.0|132.217|161.576|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.|
1633521|NCT02044367|3001336|Non-Inferiority or Equivalence|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T2/R (%)|130.43|Standard Deviation|27.1|||2-Sided|90.0|119.628|142.2|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.|
1633522|NCT02044367|3001336|Non-Inferiority or Equivalence|The sample size determination was not based on a power calculation, but to assure a precise estimation of the relative bioavailability. For this 3-way crossover trial, a precision (defined by ratio of upper CI limit to adjusted GMR) of at most 1.17 had been considered necessary and sufficient by the project team.|gMean Ratio T1/R (%)|137.01|Standard Deviation|26.8|||2-Sided|90.0|125.773|149.25|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Analysis of variance (ANOVA) on the logarithmic scale was used including effects for ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and 'subjects within sequences' as random effect. CIs were calculated based on the residual error from ANOVA.|
1633523|NCT02044094|3001366|Non-Inferiority|Blockade was achieved if the upper bound of the 95% confidence interval was <= the non-inferiority margin of 11.|LSM difference|6.677|Standard Error of the Mean|2.367|||2-Sided|95.0|1.936|11.418|||||Hydromorphone - Placebo|"Week 4~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."|
1633525|NCT02044094|3001366|Non-Inferiority|Blockade was achieved if the upper bound of the 95% confidence interval was <= the non-inferiority margin of 11.|LSM difference|4.926|Standard Error of the Mean|1.956|||2-Sided|95.0|1.016|8.837|||||Hydromorphone - Placebo|"Week 3~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."|
1633526|NCT02044094|3001366|Non-Inferiority|Blockade was achieved if the upper bound of the 95% confidence interval was <= the non-inferiority margin of 11.|LSM difference|0.863|Standard Error of the Mean|1.959|||2-Sided|95.0|-3.053|4.778|||||Hydromorphone - Placebo|"Week 3~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."|
1633527|NCT02044094|3001366|Non-Inferiority|Blockade was achieved if the upper bound of the 95% confidence interval was <= the non-inferiority margin of 11.|LSM difference|2.899|Standard Error of the Mean|1.285|||2-Sided|95.0|0.333|5.465|||||Hydromorphone - Placebo|"Week 2~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."|
1633528|NCT02044094|3001366|Non-Inferiority|Blockade was achieved if the upper bound of the 95% confidence interval was <= the non-inferiority margin of 11.|LSM difference|0.586|Standard Error of the Mean|1.283|||2-Sided|95.0|-1.977|3.149|||||Hydromorphone - Placebo|"Week 2~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."|
1633529|NCT02044094|3001366|Non-Inferiority|Blockade was achieved if the upper bound of the 95% confidence interval was <= the non-inferiority margin of 11.|LSM difference|6.927|Standard Error of the Mean|1.848|||2-Sided|95.0|3.243|10.612|||||Hydromorphone - Placebo|Week 1 Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05.|
1633530|NCT02044094|3001366|Non-Inferiority|Blockade was achieved if the upper bound of the 95% confidence interval was <= the non-inferiority margin of 11.|LSM difference|3.656|Standard Error of the Mean|1.85|||2-Sided|95.0|-0.032|7.344|||||Hydromorphone - Placebo|"Week 1~Complete hydromorphone blockade was claimed for RBP-6000 if blockade was achieved for both hydromorphone doses (6 mg and 18 mg) during each week of testing for the 4 weeks after the first dose of RBP-6000. Each test was performed at a 2-sided α = 0.05."|
1633531|NCT02043808|3001372|Superiority or Other||Crude event rate ratio|0.6|||||2-Sided|95.0|0.52|0.69|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633532|NCT02043808|3001373|Superiority or Other||Crude event rate ratio|0.97|||||2-Sided|95.0|0.34|2.81|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633533|NCT02043808|3001374|Superiority or Other||Crude event rate ratio|0.44|||||2-Sided|95.0|0.16|1.21|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633534|NCT02043808|3001375|Superiority or Other||Crude event rate ratio|0.64|||||2-Sided|95.0|0.31|1.31|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633535|NCT02043808|3001376|Superiority or Other||Crude event rate ratio|0.66|||||2-Sided|95.0|0.45|0.95|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633536|NCT02043808|3001377|Superiority or Other||Crude event rate ratio|0.83|||||2-Sided|95.0|0.55|1.26|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633537|NCT02043808|3001378|Superiority or Other||Crude event rate ratio|0.37|||||2-Sided|95.0|0.22|0.64|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633538|NCT02043808|3001379|Superiority or Other||Crude event rate ratio|0.35|||||2-Sided|95.0|0.17|0.72|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633539|NCT02043808|3001380|Superiority or Other||Crude event rate ratio|1.24|||||2-Sided|95.0|0.99|1.54|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633540|NCT02043808|3001381|Superiority or Other||Crude event rate ratio|0.72|||||2-Sided|95.0|0.5|1.03|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633541|NCT02043808|3001382|Superiority or Other||Crude event rate ratio|1.07|||||2-Sided|95.0|0.89|1.3|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633542|NCT02043808|3001383|Superiority or Other||Crude event rate ratio|0.9|||||2-Sided|95.0|0.76|1.07|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633543|NCT02043808|3001384|Superiority or Other||Crude event rate ratio|0.48|||||2-Sided|95.0|0.3|0.77|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633544|NCT02043808|3001385|Superiority or Other||Crude event rate ratio|0.31|||||2-Sided|95.0|0.13|0.7|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633545|NCT02043808|3001386|Superiority or Other||Crude event rate ratio|0.79|||||2-Sided|95.0|0.59|1.07|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633546|NCT02043808|3001387|Superiority or Other||Crude event rate ratio|0.83|||||2-Sided|95.0|0.71|0.98|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633547|NCT02043808|3001388|Superiority or Other||Crude event rate ratio|0.69|||||2-Sided|95.0|0.52|0.92|||||Crude event rate ratio for dabigatran with warfarin as the reference group||
1633548|NCT02043704|3001402|Equivalence|The null hypothesis is that there is no difference in the pain scores between the groups.||||||0.328||||||The p-value was not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|There were no adjustments.||The comparison was analyzed using the Mann-Whitney U test.|
1633549|NCT02043678|3001403|Superiority||Hazard Ratio (HR)|1.126||||0.2467|2-Sided|95.0|0.921|1.378|||Cox Proportional Hazards Model||||
1633550|NCT02043678|3001404|Superiority||Hazard Ratio (HR)|1.033||||0.7871|2-Sided|95.0|0.816|1.308|||Cox Proportional Hazards Model||||
1633551|NCT02043678|3001405|Superiority||Hazard Ratio (HR)|1.145||||0.1669|2-Sided|95.0|0.945|1.389|||Cox Proportional Hazards Model||||
1633552|NCT02043678|3001406|Superiority||Hazard Ratio (HR)|1.152||||0.1283|2-Sided|95.0|0.96|1.383|||Cox Proportional Hazards Model||||
1633560|NCT02043509|3001421|Superiority||Adjusted odds ratio|1.34|||||2-Sided|95.0|0.79|2.31|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.||
1633561|NCT02043509|3001422|Superiority||Adjusted odds ratio|1.03|||||2-Sided|95.0|0.61|1.75|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.||
1633562|NCT02043509|3001423|Superiority||Adjusted odds ratio|2.7|||||2-Sided|95.0|0.93|9.35|||||Odds ratios are model-based (adjusted by site and gestation at randomization). 95% profile confidence intervals are reported.||
1633563|NCT02043379|3001424|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.79||||||A p-value of <0.05 represents the threshold for statistical significance|t-test, 2 sided|||24 hour post-operative max|
1633564|NCT02043379|3001424|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.87||||||A p-value of <0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative|
1633565|NCT02043379|3001425|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.68||||||A p-value of <0.05 represents the threshold for statistical significance|t-test, 2 sided|||max|
1633566|NCT02043379|3001425|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.43||||||A p-value of <0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative|
1633567|NCT02043379|3001426|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.04||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||24 hour level|
1633568|NCT02043379|3001426|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.79||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||12 hour level|
1633569|NCT02043379|3001426|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||8 hour level|
1633570|NCT02043379|3001426|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||4 hour level|
1633571|NCT02043379|3001426|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.37||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0 hour level|
1633572|NCT02043379|3001427|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.78||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative|
1633573|NCT02043379|3001427|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.9||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative|
1633574|NCT02043379|3001427|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.82||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative|
1633575|NCT02043379|3001427|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.14||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative|
1633576|NCT02043379|3001427|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.04||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative|
1633577|NCT02043379|3001427|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.46||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative|
1633578|NCT02043379|3001428|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative|
1633579|NCT02043379|3001428|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.67||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative|
1633580|NCT02043379|3001428|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.35||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative|
1633581|NCT02043379|3001428|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative|
1633582|NCT02043379|3001428|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.02||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative|
1633583|NCT02043379|3001428|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.1||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative|
1633584|NCT02043379|3001429|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative|
1633585|NCT02043379|3001429|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.61||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative|
1633586|NCT02043379|3001429|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.36||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative|
1633587|NCT02043379|3001429|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.58||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative|
1633588|NCT02043379|3001429|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.39||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative|
1633589|NCT02043379|3001429|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.35||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative|
1633590|NCT02043379|3001430|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative|
1633591|NCT02043379|3001430|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.88||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative|
1633592|NCT02043379|3001430|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.27||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative|
1633593|NCT02043379|3001430|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.51||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative|
1633594|NCT02043379|3001430|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.12||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative|
1633595|NCT02043379|3001430|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.1||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative|
1633596|NCT02043379|3001431|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.4||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative|
1633597|NCT02043379|3001431|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.38||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative|
1633598|NCT02043379|3001431|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.31||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative|
1633599|NCT02043379|3001431|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.42||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative|
1633600|NCT02043379|3001431|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.37||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative|
1633601|NCT02043379|3001431|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.28||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative|
1633602|NCT02043379|3001432|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.44||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hour post-operative|
1633603|NCT02043379|3001432|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.82||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hour post-operative|
1633604|NCT02043379|3001432|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.42||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hour post-operative|
1633605|NCT02043379|3001432|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.47||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative|
1633606|NCT02043379|3001432|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative|
1633607|NCT02043379|3001432|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.41||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative|
1633608|NCT02043379|3001433|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.63||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)||||
1633609|NCT02043379|3001434|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.72||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)||||
1633610|NCT02043379|3001435|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.52||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0-24 hours post CPB|
1633611|NCT02043379|3001435|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.09||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0-48 hours post-CPB|
1633612|NCT02043379|3001436|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.4||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)||||
1633613|NCT02043379|3001437|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||1||||||A p-value of <0.05 represents the threshold for statistical significance.|Chi-squared||||
1633614|NCT02043379|3001438|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.02||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||24 hour level|
1633783|NCT02038881|3001870|Other||Diff in SC rate (Gr2 [W56] - Gr3 [W64])|-15.2|||||2-Sided|95.0|-40.5|10.5|||||||
1633615|NCT02043379|3001438|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.13||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||12 hour level|
1633616|NCT02043379|3001438|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.14||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||8 hour level|
1633617|NCT02043379|3001438|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.34||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||4 hour level|
1633618|NCT02043379|3001438|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.27||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||0 hour levels|
1633619|NCT02043379|3001439|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.83||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||48 hours post-operative|
1633620|NCT02043379|3001439|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.05||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hours post-operative|
1633621|NCT02043379|3001439|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.33||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative|
1633622|NCT02043379|3001439|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.06||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||4 hour post-operative|
1633623|NCT02043379|3001439|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.06||||||A p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||0 hour post-operative|
1633624|NCT02043379|3001439|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.6||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||pre-operative|
1633625|NCT02043379|3001440|Non-Inferiority or Equivalence|power calculations were not performed on this statistical calculation|||||<|0.01||||||p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||post-operative day 5 (120 hours) IgG level|
1633626|NCT02043379|3001440|Non-Inferiority or Equivalence|power calculations were not performed on this statistical calculation|||||<|0.01||||||p-value of <0.05 represents the threshold for statistical signficance|Wilcoxon (Mann-Whitney)|||post-operative day 3 (72 hours) IgG level|
1633627|NCT02043379|3001440|Non-Inferiority or Equivalence|power calculations were not performed on this statistical calculation|||||<|0.36||||||a p-value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative IgG level|
1633628|NCT02043379|3001440|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.|||||<|0.32||||||A p-value of <0.05 represents the threshold for statistical significance.|t-test, 2 sided|||pre-operative IgG level|
1633629|NCT02043379|3001441|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.79||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)||||
1633630|NCT02043379|3001442|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.49||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)||||
1633631|NCT02043379|3001443|Non-Inferiority or Equivalence|power calculations were not performed on this statistical calculation||||||0.23||||||a p-value of <0.05 represents the threshold for statistical signficance|Wilcoxon (Mann-Whitney)|||48 hours post-operative inotrope score|
1633632|NCT02043379|3001443|Non-Inferiority or Equivalence|power calculations were not performed on this statistical calculation||||||0.9||||||a p value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||24 hours post-operative inotrope score|
1633633|NCT02043379|3001443|Non-Inferiority or Equivalence|power calculations were not performed on this statistical calculation||||||0.82||||||a p value of <0.05 represents the threshold for statistical significance|Wilcoxon (Mann-Whitney)|||12 hours post-operative inotrope score|
1633634|NCT02043379|3001443|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.81||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)|||Admit Inotrope Score|
1633635|NCT02043379|3001444|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.52||||||A p-value of <0.05 represents the threshold for statistical significance.|Wilcoxon (Mann-Whitney)||||
1633636|NCT02043379|3001445|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.06||||||a p-value of <0.05 represents the threshold for test signficance|t-test, 2 sided|||48 hour post CPB albumin|
1633637|NCT02043379|3001445|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation||||||0.42||||||A p-value of <0.05 represents the threshold for statistical significance.|t-test, 2 sided|||24 hour post-CPB albumin|
1633638|NCT02043379|3001446|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.26||||||A p-value of <0.05 represents the threshold for statistical significance.|Chi-squared||||
1633639|NCT02043379|3001447|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.38||||||A p-value of <0.05 represents the threshold for statistical significance.|Chi-squared||||
1633640|NCT02043379|3001448|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||1||||||A p-value of <0.05 represents the threshold for statistical significance.|Chi-squared||||
1633641|NCT02043379|3001449|Non-Inferiority or Equivalence|We used alpha level of 0.05 and power of 0.8 to calculate the sample size necessary to detect a meaningful clinical difference for our primary endpoint.||||||1||||||A p-value of <0.05 represents the threshold for statistical significance.|Chi-squared||||
1633784|NCT02038881|3001870|Other||Diff in SC rate (Gr2 [W30] - Gr3 [W38])|-10.6|||||2-Sided|95.0|-35.6|14.3|||||||
1633644|NCT02043301|3001462|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|91.15|||||2-Sided|90.0|70.269|118.248|||||||
1633645|NCT02043301|3001462|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|79.09|||||2-Sided|90.0|60.883|102.735|||||||
1633646|NCT02043301|3001463|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|102.02|||||2-Sided|90.0|97.131|107.151|||||||
1633647|NCT02043301|3001463|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|102.51|||||2-Sided|90.0|97.555|107.717|||||||
1633648|NCT02043301|3001465|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|93.52|||||2-Sided|90.0|83.359|104.912|||||||
1633649|NCT02043301|3001465|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.1|||||2-Sided|90.0|86.558|108.926|||||||
1633650|NCT02043301|3001466|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|93.52|||||2-Sided|90.0|83.359|104.912|||||||
1633651|NCT02043301|3001466|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.1|||||2-Sided|90.0|86.558|108.926|||||||
1633652|NCT02043301|3001467|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|103.96|||||2-Sided|90.0|90.405|119.557|||||||
1633653|NCT02043301|3001467|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|97.35|||||2-Sided|90.0|84.659|111.943|||||||
1633654|NCT02043301|3001472|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|100.27|||||2-Sided|90.0|82.54|121.82||||||Upper Arm (Test) versus Abdomen (Reference)|
1633655|NCT02043301|3001472|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|129.98|||||2-Sided|90.0|106.76|158.27||||||Thigh (Test) versus Abdomen (Reference)|
1633656|NCT02043301|3001473|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|86.16|||||2-Sided|90.0|72.49|102.4||||||Upper Arm (Test) versus Abdomen (Reference)|
1633657|NCT02043301|3001473|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|127.65|||||2-Sided|90.0|107.19|152.02||||||Thigh (Test) versus Abdomen (Reference)|
1633658|NCT02043301|3001474|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|94.93|||||2-Sided|90.0|80.2|112.38||||||Upper Arm (Test) versus Abdomen (Reference)|
1633659|NCT02043301|3001474|Superiority or Other|Ratios (and 90% confidence intervals) were expressed as percentages.|Adjusted Geometric Means Ratio (%)|120.96|||||2-Sided|90.0|101.99|143.45||||||Thigh (Test) versus Abdomen (Reference)|
1633660|NCT02042534|3001532|Superiority or Other|||||||0.3301|||||||Cochran-Mantel-Haenszel||||
1633661|NCT02042534|3001533|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test|||
1633662|NCT02042534|3001534|Superiority or Other|||||||0.3753|||||||Chi-squared||||
1633663|NCT02042534|3001535|Superiority or Other|||||||0.6765|||||||Chi-squared||||
1633664|NCT02042443|3001540|Superiority||Hazard Ratio (HR)|2.02||||0.05|2-Sided|95.0|1.01|4.03|||Log Rank||||
1633665|NCT02042404|3001542|Superiority or Other|||||||0.0281|||||||repeated measures ANOVA||||
1633666|NCT02042404|3001543|Superiority or Other||||||<|0.0001|||||||repeated measures ANOVA||||
1633667|NCT02042404|3001544|Superiority or Other||||||<|0.0001|||||||repeated measures ANOVA||||
1633668|NCT02042404|3001545|Superiority or Other||||||<|0.0001|||||||repeated measures ANOVA||||
1633669|NCT02042131|3001548|Superiority||Odds Ratio (OR)|0.1||||0.045|2-Sided|95.0|0.002|0.9|||Chi-squared|||Planned contrast #2: E-CRP vs. TAU/S-CRP|
1633670|NCT02042131|3001548|Superiority|||||||0.04|||||||Chi-squared|||Omnibus test of all groups|
1633671|NCT02042131|3001549|Superiority||||||<|0.001|||||||Mixed Models Analysis|||Planned contrast #1: TAU vs. S-CRP/E-CRP|
1633672|NCT02042131|3001550|Superiority||||||<|0.001|||||||Mixed Models Analysis|||Planned contrast #1: TAU vs. S-CRP/E-CRP|
1633673|NCT02042131|3001550|Superiority||||||<|0.001|||||||Mixed Models Analysis|||Omnibus test comparing all three groups.|
1633674|NCT02042131|3001551|Superiority||Cox Proportional Hazard|0.24||||0.04|2-Sided|95.0|0.06|0.96|||Regression, Cox|||Planned contrast #1: TAU vs. S-CRP/E-CRP|
1633675|NCT02042131|3001551|Superiority|||||||0.028|||||||Log Rank|||Planned contrast #1: TAU vs. S-CRP/E-CRP|
1633676|NCT02042131|3001551|Superiority|||||||0.082|||||||Log Rank|||Omnibus test of all three groups|
1633677|NCT02041702|3001555|Non-Inferiority|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|2.6||||0.0002|2-Sided|90.0|-3.2|8.4|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI – PCTRL≤ -10% vs H1: PMRI – PCTRL >-10%~PMRI: the success rate in the Cardiac MRI Scan Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~PCTRL: the success rate in the Control Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"|
1633678|NCT02041702|3001556|Non-Inferiority|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-2.7||||0.0446|2-Sided|90.0|-9.8|4.3|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was:H0: PMRI – PCTRL≤ -10% vs H1: PMRI – PCTRL >-10%~PMRI: the success rate in MRI Scan Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~PCTRL: the success rate in Control Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"|
1633785|NCT02038881|3001870|Other||Diff in SC rate (Gr3 [W64] - Gr1 [W56])|16.7|||||2-Sided|95.0|-11.0|44.4|||||||
1633679|NCT02041702|3001557|Non-Inferiority|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-1.7||||0.0012|2-Sided|90.0|-6.2|2.8|||Farrington-Manning test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI – PCTRL≤ -10% vs H1: PMRI – PCTRL >-10%~PMRI: the success rate in the Cardiac MRI Scan Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit~PCTRL: the success rate in Control Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit"|
1633680|NCT02041702|3001558|Non-Inferiority|The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.|Ratio Difference|-0.9||||0.0007|2-Sided|90.0|-5.6|3.8|||Farrington-Manning Test||The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.|"The hypothesis was: H0: PMRI – PCTRL≤ -10% vs H1: PMRI – PCTRL>-10%~PMRI: the success rate in the Cardiac MRI scan group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit~PCTRL: the success rate in the Control group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit"|
1633681|NCT02041702|3001559|Superiority|The 2-sided 90% confidence interval (CI) was calculated using the Clopper-Pearson method.|Ratio|100.0|||<|0.01|2-Sided|90.0|97.6|100.0|||Clopper-Pearson|Clopper-Pearson CI for the binomial proportion|The null hypothesis would be rejected if the lower bound of the 2-sided 90% confidence interval was greater than 90%.|The hypothesis was: H0: P≤ 90% vs H1: P>90% P: The proportion of subjects free from MRI scan related complications at 1 month post MRI scan in cardiac MRI scan group|
1633682|NCT02041533|3001563|Superiority or Other (legacy)||Odds Ratio (OR)|0.7|||||2-Sided|95.0|0.46|1.06|||||Stratified by histology (squamous vs.non-squamous) at randomization. Strata adjusted odds ratio (Nivolumab over investigator choice of chemotherapy) using Mantel-Haenszel method.||
1633683|NCT02041533|3001564|Superiority or Other (legacy)||Hazard Ratio (HR)|1.07|||||2-Sided|95.0|0.86|1.33|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.||
1633684|NCT02041533|3001565|Superiority or Other (legacy)||Hazard Ratio (HR)|1.02|||||2-Sided|95.0|0.8|1.3|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.||
1633685|NCT02041533|3001566|Superiority or Other (legacy)||Hazard Ratio (HR)|1.17|||||2-Sided|95.0|0.95|1.43|||||Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.||
1633686|NCT02041533|3001567|Superiority or Other (legacy)||Hazard Ratio (HR)|1.15||||0.2511|2-Sided|95.0|0.91|1.45|||Log Rank|Log-rank test stratified by histology (squamous vs. non-squamous) as entered into the IVRS.|Stratified Cox proportional hazard model. Hazard ratio of nivolumab to investigator's choice chemotherapy.||
1633687|NCT02040805|3001641|Other|linear mixed model|||||<|0.0001|||||||Mixed Models Analysis|df=1|||
1633688|NCT02040805|3001642|Other|linear mixed models analysis|||||<|0.0001|||||||Mixed Models Analysis|df=1|||
1633689|NCT02040805|3001643|Non-Inferiority|Margin based on clinically meaningful change of >= 2.5 points.||||||0.05|||||||t-test, 1 sided|||Test of non-inferiority.|
1633690|NCT02040805|3001644|Non-Inferiority|Margin based on clinically meaningful change of >= 5 points.||||||0.04|||||||t-test, 1 sided|||Test of non-inferiority.|
1633691|NCT02040779|3001649|Superiority|||||||0.0208|||||||Log Rank||||
1633692|NCT02040779|3001649|Superiority|||||||0.2384|||||||Log Rank||||
1633693|NCT02040779|3001651|Superiority||LSM difference|-0.127||||0.0509|2-Sided|95.0|-0.255|0.001||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 80 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.|
1633694|NCT02040779|3001651|Superiority||LSM difference|-0.137||||0.0335|2-Sided|95.0|-0.263|-0.011||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.|
1633695|NCT02040779|3001652|Superiority||LSM difference|-0.358||||0.0285|2-Sided|95.0|-0.678|-0.038||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 80 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.|
1633696|NCT02040779|3001652|Superiority||LSM difference|-0.388||||0.0175|2-Sided|95.0|-0.708|-0.068||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.|
1633725|NCT02040766|3001661|Superiority||Mean Difference (Final Values)|0.63||||0.5332|2-Sided|95.0|-1.354|2.614||significance at 0.05.|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (ICS or NCS therapy) at the time of screening visit, during the run-in period, and during treatment.|
1633786|NCT02038881|3001870|Other||Diff in SC rate (Gr3 [W38] - Gr1 [W30])|5.6|||||2-Sided|95.0|-19.6|33.0|||||||
1633697|NCT02040779|3001653|Superiority||LSM difference|10.902||||0.0112|2-Sided|95.0|2.5|19.303||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.|
1633698|NCT02040779|3001653|Superiority||LSM difference|5.405||||0.2014|2-Sided|95.0|-2.905|13.715||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.|
1633699|NCT02040779|3001654|Superiority||LSM difference|13.645||||0.0007|2-Sided|95.0|5.843|21.446||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.|
1633700|NCT02040779|3001654|Superiority||LSM difference|7.911||||0.0443|2-Sided|95.0|0.202|15.621||a priori threshold for significance of 0.05.|mixed model for repeated measures||BDP 160 mcg BAI - Placebo BAI|Treatment comparisons began with am PEF for BDP 160 mcg BAI vs placebo. If the p-value was ≤0.05, the next comparisons of interest were made 1) the next secondary outcome comparison for BDP 160 mcg BAI vs placebo and 2) the am PEF for BDP 80 mcg BAI vs placebo. This procedure allowed for control of the Type I error for comparisons at a particular BAI treatment over the 5 secondary endpoints, as well as comparisons within an endpoint. It did not control the overall Type I error.|
1633701|NCT02040779|3001655|Superiority||LSM difference|0.124||||0.0005|2-Sided|95.0|0.054|0.193||ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.|ANCOVA||BDP 80 mcg BAI - Placebo BAI||
1633702|NCT02040779|3001655|Superiority||LSM difference|0.116||||0.001|2-Sided|95.0|0.048|0.185||ANCOVA model with effects due to baseline trough morning FEV1, sex, age, current protocol-allowed asthma therapy (ICS or non-corticosteroid therapy) at the time of screening visit and during the run-in period and treatment.|ANCOVA||BDP 160 mcg BAI - Placebo BAI|A fixed-sequence multiple testing procedure was used while controlling the family-wise error rate at 5%. If the 2-sided p-value resulting from the ANCOVA model for comparing beclomethasone dipropionate BAI 160 mcg/day versus placebo was less than 0.05, then the comparison of the 80 mcg/day versus placebo was to be interpreted inferentially.|
1633703|NCT02040766|3001656|Superiority|||||||0.7633|||||||Log Rank||||
1633704|NCT02040766|3001656|Superiority|||||||0.9982|||||||Log Rank||||
1633705|NCT02040766|3001656|Superiority|||||||0.5257|||||||Log Rank||||
1633706|NCT02040766|3001656|Superiority|||||||0.287|||||||Log Rank||||
1633707|NCT02040766|3001657|Superiority||Mean Difference (Final Values)|-0.08||||0.1041|2-Sided|95.0|-0.18|0.017|||Mixed Models Analysis||||
1633708|NCT02040766|3001657|Superiority||Mean Difference (Final Values)|-0.04||||0.4388|2-Sided|95.0|-0.138|0.06|||Mixed Models Analysis||||
1633709|NCT02040766|3001657|Superiority||Mean Difference (Final Values)|-0.09||||0.0869|2-Sided|95.0|-0.185|0.013|||Mixed Models Analysis||||
1633710|NCT02040766|3001657|Superiority||Mean Difference (Final Values)|-0.16||||0.0011|2-Sided|95.0|-0.261|-0.065|||Mixed Models Analysis||||
1633711|NCT02040766|3001658|Superiority||Mean Difference (Final Values)|-0.18||||0.0587|2-Sided|95.0|-0.369|0.007|||Mixed Models Analysis||||
1633712|NCT02040766|3001658|Superiority||Mean Difference (Final Values)|-0.05||||0.5866|2-Sided|95.0|-0.24|0.136|||Mixed Models Analysis||||
1633713|NCT02040766|3001658|Superiority||Mean Difference (Final Values)|-0.14||||0.132|2-Sided|95.0|-0.331|0.044|||Mixed Models Analysis||||
1633714|NCT02040766|3001658|Superiority||Mean Difference (Final Values)|-0.36||||0.0002|2-Sided|95.0|-0.548|-0.174|||Mixed Models Analysis||||
1633715|NCT02040766|3001659|Superiority||Mean Difference (Final Values)|8.7||||0.0031|2-Sided|95.0|2.95|14.49|||Mixed Models Analysis||||
1633716|NCT02040766|3001659|Superiority||Mean Difference (Final Values)|9.9||||0.0008|2-Sided|95.0|4.11|15.68|||Mixed Models Analysis||||
1633717|NCT02040766|3001659|Superiority||Mean Difference (Final Values)|10.0||||0.0007|2-Sided|95.0|4.2|15.76|||Mixed Models Analysis||||
1633718|NCT02040766|3001659|Superiority||Mean Difference (Final Values)|11.7|||<|0.0001|2-Sided|95.0|5.96|17.45|||Mixed Models Analysis||||
1633719|NCT02040766|3001660|Superiority||Mean Difference (Final Values)|6.5||||0.0278|2-Sided|95.0|0.71|12.23|||Mixed Models Analysis||||
1633720|NCT02040766|3001660|Superiority||Mean Difference (Final Values)|7.6||||0.0103|2-Sided|95.0|1.79|13.35|||Mixed Models Analysis||||
1633721|NCT02040766|3001660|Superiority||Mean Difference (Final Values)|8.5||||0.0041|2-Sided|95.0|2.71|14.24|||Mixed Models Analysis||||
1633722|NCT02040766|3001660|Superiority||Mean Difference (Final Values)|11.3||||0.0001|2-Sided|95.0|5.58|17.06|||Mixed Models Analysis||||
1633723|NCT02040766|3001661|Superiority||Mean Difference (Final Values)|1.09||||0.2823|2-Sided|95.0|-0.902|3.088|||ANCOVA||||
1633724|NCT02040766|3001661|Superiority||Mean Difference (Final Values)|0.92||||0.3649|2-Sided|95.0|-1.077|2.924||significance at 0.05|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (ICS or NCS therapy) at the time of screening visit, during the run-in period, and during treatment.|
1633776|NCT02038881|3001868|Other||Difference in seroconversion rates (%)|-2.2|||||2-Sided|95.0|-12.0|13.2|||||||
1633777|NCT02038881|3001869|Other||Diff in SC rate (Gr 3 - Gr 1) at Week 6|-3.8|||||2-Sided|95.0|-20.5|13.4|||||||
1633726|NCT02040766|3001661|Superiority||Mean Difference (Final Values)|2.81||||0.0063|2-Sided|95.0|0.796|4.821||significance at 0.05.|ANCOVA|||ANCOVA model with effects due to baseline trough morning percent predicted FEV1, sex, age, current protocol-allowed asthma therapy (inhaled corticosteroid (ICS) or non-corticosteroid (NCS) therapy) at the time of screening visit, during the run-in period, and during treatment.|
1633727|NCT02040584|3001673|Superiority or Other|||||||0.9423|||||||Fisher Exact|Week 52||"Null hypothesis (H0): there were no differences in kidney function between the two groups, in contrast with the alternative hypothesis (H1), in which there were differences:~HO: CBS = CBC versus H1: CBS ≠ CBC, where CBS and CBC were percentages of patients who showed clinical benefit at Week 52 for the study group and control group, respectively."|
1633728|NCT02040428|3001684|Superiority or Other|||||||0.0046|||||||Chi-squared||||
1633729|NCT02040428|3001685|Superiority or Other|||||||0.0001|||||||Adaptive group sequential design|Whitehead method for triangular test||Superiority|
1633730|NCT02039947|3001698|Superiority||Response rate|59.0|||<|0.0001|2-Sided|95.0|47.3|70.4|||percent||Percent||
1633731|NCT02039856|3001702|Superiority|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|0.021|Standard Error of the Mean|0.15||0.888|2-Sided|95.0|-0.265|0.306|||Regression, Linear||The estimated value is predicted change in the number of VA emergency room visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of emergency room visits for any cause between EBQI and control over time|
1633732|NCT02039856|3001703|Superiority|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|-0.018|Standard Error of the Mean|0.068||0.794|2-Sided|95.0|-0.15|0.12|||Regression, Linear||The estimated value is predicted change in the number of VA hospitalization, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient hospitalization for any cause between EBQI and control over time|
1633733|NCT02039856|3001704|Superiority|Difference-in-differences analysis using linear regression, adjusted for adjusted for survey weights, age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|1.69|Standard Error of the Mean|0.413||0|2-Sided|95.0|0.88|2.51|||Regression, Linear||The estimated value is predicted change in the number of VA women's health visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient visits to women's health care between EBQI and control over time|
1633734|NCT02039856|3001705|Superiority|Difference-in-differences analysis using linear regression, adjusted for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Net)|1.25|Standard Error of the Mean|0.56||0.008|2-Sided|95.0|0.14|2.36|||Regression, Linear||The estimated value is predicted change in the number of VA primary care visits, adjusting for characteristics described in the statistical analysis overview.|Change in number of patient primary care visits between EBQI and control over time|
1633735|NCT02039856|3001706|Superiority|We adjusted our analysis using the population weights, which were the product of design weights and non-response weights|Odds Ratio (OR)|0.36|Standard Error of the Mean|0.1922||0.058|2-Sided|95.0|0.13|1.04|||Regression, Logistic||The estimated value is the predicted mean, adjusting for weights, worked in women's health vs general PC clinic, years worked at the VA, race/ethnicity, gender, full-time employment, and percent of women veterans enrolled at the VA facility.||
1633736|NCT02039856|3001707|Superiority|Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Mean Difference (Final Values)|0.43|Standard Error of the Mean|0.2253||0.055|2-Sided|95.0|-0.01|0.87|||Regression, Linear||The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.|Change in team functioning score between EBQI and control over time.|
1633737|NCT02039856|3001708|Superiority|Difference-in-differences analysis using linear regression, adjusted for gender, race/ethnicity, years worked at VA, worked in women's health clinic vs general primary care clinic, clinician status vs staff status, fulltime employment, percent of women veterans enrolled at the VA facility. We adjusted our analysis using the population weights, which were the product of design weights and non-response weights.|Median Difference (Final Values)|0.33|Standard Error of the Mean|0.1195||0.006|2-Sided|95.0|0.1|0.57|||Regression, Linear||The estimated value reported here is the predicted mean change over time, adjusting for characteristics described in the statistical analysis overview.|Change in gender sensitivity score between EBQI and control over time|
1633738|NCT02039856|3001709|Superiority|Difference-in-differences using ordered logistic regression, adjusting for age, gender, race/ethnicity, marital status, employment, education, dual use of VA and non-VA for care, diagnosis of PTSD, and the population weights, which were the product of design weights and non-response weights. We verified that proportional odds assumption was met.|Odds Ratio (OR)|0.913|Standard Error of the Mean|0.175||0.637|2-Sided|95.0|0.627|1.33|||difference-in-differences analysis||The estimated value is predicted change in the odds of WH-PACT achievement, adjusting for characteristics described in the statistical analysis overview.|Change in the odds of achieving a higher WH-PACT element.|
1633739|NCT02039726|3001718|Other||Hazard Ratio (HR)|0.898||||0.2034|2-Sided|95.0|0.697|1.157|||P value for HR=1 (1-sided)|||Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy [MEC or FLAG-IDA], or low intensity chemotherapy [LoDAC]).|
1633778|NCT02038881|3001869|Other||Diff in SC rate (Gr 3 - Gr 1) at Week 4|20.8|||||2-Sided|95.0|-7.7|47.8|||||||
1633740|NCT02039726|3001719|Other||Hazard Ratio (HR)|0.758||||0.0185|2-Sided|95.0|0.584|0.983|||P-value for HR=1 (1-sided)|||Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy [MEC or FLAG-IDA], or low intensity chemotherapy [LoDAC]).|
1633741|NCT02039674|3001726|Superiority or Other (legacy)||Hazard Ratio (HR)|0.9||||0.38912|2-Sided|95.0|0.42|1.91|||Log Rank|One-sided p-value based on log-rank test|||
1633742|NCT02039674|3001727|Superiority or Other (legacy)||Hazard Ratio (HR)|0.53||||0.01024|2-Sided|95.0|0.31|0.91|||Log Rank|One-sided p-value based on log-rank test|||
1633743|NCT02039674|3001729|Superiority|||||||0.0858|||||||Exact binomial distribution for testing|HO: ORR ≤20% versus H1: ORR >20%|||
1633744|NCT02039674|3001730|Superiority or Other (legacy)||Difference in Percentages|26.3||||0.0016|2-Sided|95.0|8.9|42.1|||Miettinen & Nurminen Method||||
1633745|NCT02039505|3001737|Superiority||Adjusted Odds Ratio|3.38||||0.1571|2-Sided|95.0|0.636|17.981|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.||
1633746|NCT02039505|3001738|Superiority||Adjusted Odds Ratio|2.02||||0.209|2-Sided|95.0|0.677|6.033|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.||
1633747|NCT02039505|3001739|Superiority||Adjusted Odds Ratio|3.49||||0.0066|2-Sided|95.0|1.409|8.642|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.||
1633748|NCT02039505|3001740|Superiority||Adjusted Odds Ratio|3.48||||0.0067|2-Sided|95.0|1.407|8.626|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.||
1633749|NCT02039505|3001741|Superiority||Adjusted Odds Ratio|1.33||||0.3168|2-Sided|95.0|0.755|2.356|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.||
1633750|NCT02039505|3001742|Superiority||Adjusted Odds Ratio|1.66||||0.198|2-Sided|95.0|0.762|3.596|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.||
1633751|NCT02039505|3001748|Superiority||Adjusted Odds Ratio|2.88||||0.021|2-Sided|95.0|1.168|7.108|||Cochran-Mantel-Haenszel||CMH test was used for analysis. Prior TNFα antagonist use (yes/no) was used as stratification factor.||
1633752|NCT02039505|3001749|Superiority||Adjusted Odds Ratio|1.37||||0.2722|2-Sided|95.0|0.779|2.399|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.||
1633753|NCT02039219|3001767|Superiority|The type of statistical test is superiority.|Mean Difference (Final Values)|0.4|Standard Deviation|2.5||0.8094|2-Sided|95.0|||||t-test, 2 sided||||
1633754|NCT02039219|3001771|Superiority|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|2-Sided||||||Log Rank|||Day 180|
1633755|NCT02039219|3001771|Superiority|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|2-Sided||||||Log Rank|||Day 90|
1633756|NCT02039219|3001771|Superiority|The type of statistical test is superiority.|Survival Analysis|0.09||||0.3938|2-Sided||||||Log Rank|||Day 42|
1633757|NCT02039219|3001771|Superiority|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|2-Sided||||||Log Rank|||Day 180|
1633758|NCT02039219|3001771|Superiority|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|2-Sided||||||Log Rank|||Day 90|
1633759|NCT02039219|3001771|Superiority|The type of statistical test is superiority.|Survival Anaylsis|0.0||||0.3938|1-Sided||||||Log Rank|||Day 42|
1633760|NCT02039219|3001779|Superiority|The type of statistical test is superiority.|Mean Difference (Net)|2.4|Standard Deviation|6.8||0.3839|2-Sided|95.0|||||t-test, 2 sided||Two-sample t-test compared MELD score between OCA and placebo arms at day 42 OCA arms had a mean (SD) of 11.5 (6.8), Placebo arms had a mean (SD) of 13.9(4.6).|Day 42|
1633761|NCT02039219|3001779|Superiority|The type of statistical test is superiority.|Mean Difference (Net)|1.5|Standard Deviation|2.4||0.1758|2-Sided|95.0|||||t-test, 2 sided||Two-sample t-test compared MELD score between OCA and placebo arms at baseline OCA arms had a mean (SD) of 14.9(2.4), Placebo arms had a mean (SD) of 16.4 (2.2).|Baseline|
1633762|NCT02038959|3001785|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1633763|NCT02038959|3001790|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1633764|NCT02038920|3001814|Superiority|||||||0.2059|||||||Pearson's Chi-square Test||||
1633765|NCT02038920|3001815|Superiority||Odds Ratio (OR)|1.5||||0.6534|2-Sided|95.0|0.254|8.844|||Pearson's Chi-square Test||MLN0002 group/placebo group.||
1633766|NCT02038920|3001816|Superiority||Odds Ratio (OR)|15.4||||0.0094|2-Sided|95.0|1.473|160.972|||Pearson's Chi-square Test||||
1633767|NCT02038920|3001818|Superiority||Odds Ratio (OR)|1.83||||0.1963|2-Sided|95.0|0.72|4.673|||Cochran-Mantel-Haenszel||MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.||
1633768|NCT02038920|3001824|Superiority||Odds Ratio (OR)|3.57||||0.1779|2-Sided|95.0|0.532|23.953|||Pearson's Chi-square Test||MLN0002 group/placebo group||
1633769|NCT02038920|3001825|Superiority||Odds Ratio (OR)|1.8||||0.1448|2-Sided|95.0|0.816|3.958|||Cochran-Mantel-Haenszel||MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.||
1633770|NCT02038881|3001866|Other||Diff in SC rate (Gr2 [W56] - Gr3 [W64])|-23.1|||||2-Sided|95.0|-46.7|-1.0|||||||
1633771|NCT02038881|3001866|Other||Diff in SC rate (Gr2 [W30] - Gr3 [W38])|-9.8|||||2-Sided|95.0|-33.0|11.7|||||||
1633772|NCT02038881|3001866|Other||Diff in SC rate (Gr3 [W64] - Gr1 [W56])|29.2|||||2-Sided|95.0|5.8|55.4|||||||
1633773|NCT02038881|3001866|Other||Diff in SC rate (Gr3 [W38] - Gr1 [W30])|19.4|||||2-Sided|95.0|-4.5|45.8|||||||
1633774|NCT02038881|3001867|Other||Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])|0.0|||||2-Sided|95.0|-16.2|13.4|||||||
1633775|NCT02038881|3001867|Other||Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])|0.0|||||2-Sided|95.0|-17.1|13.4|||||||
1634501|NCT02033213|3002436|Superiority or Other|||||||0.362|||||||t-test, 1 sided||||
1633787|NCT02038881|3001871|Other||Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])|0.0|||||2-Sided|95.0|-16.2|13.4|||||||
1633788|NCT02038881|3001871|Other||Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])|0.0|||||2-Sided|95.0|-17.1|13.4|||||||
1633789|NCT02038881|3001872|Other||Difference in seroconversion rates (%)|-4.3|||||2-Sided|95.0|-15.2|11.6|||||||
1633790|NCT02038881|3001873|Other||Diff in SC rate (Gr 3 - Gr 1) at Week 6|-7.7|||||2-Sided|95.0|-25.1|10.1|||||||
1633791|NCT02038881|3001873|Other||Diff in SC rate (Gr 3 - Gr 1) at Week 4|-5.8|||||2-Sided|95.0|-32.8|22.2|||||||
1633792|NCT02038881|3001873|Other||Diff in SC rate (Gr 1 - Gr 2) at Week 56|-1.5|||||2-Sided|95.0|-31.5|29.2|||||||
1633793|NCT02038881|3001873|Other||Diff in SC rate (Gr 1 - Gr 2) at Week 30|5.1|||||2-Sided|95.0|-24.5|32.6|||||||
1633794|NCT02038881|3001873|Other||Diff in SC rate (Gr 1 - Gr 2) at Week 6|0.0|||||2-Sided|95.0|-16.8|16.3|||||||
1633795|NCT02038881|3001873|Other||Diff in SC rate (Gr 1 - Gr 2) at Week 4|-7.6|||||2-Sided|95.0|-34.1|17.9|||||||
1633796|NCT02038881|3001874|Other||GMT Ratio (Group 2 [W56]/ Group 3 [W64])|0.233|||||2-Sided|95.0|0.1|0.541|||||||
1633797|NCT02038881|3001874|Other||GMT Ratio (Group 2 [W30]/ Group 3 [W38])|0.278|||||2-Sided|95.0|0.115|0.672|||||||
1633798|NCT02038881|3001874|Other||GMT Ratio (Group 3 [W64]/ Group 1 [W56])|7.275|||||2-Sided|95.0|2.693|19.649|||||||
1633799|NCT02038881|3001874|Other||GMT Ratio (Group 3 [W38]/ Group 1 [W30])|6.727|||||2-Sided|95.0|2.493|18.15|||||||
1633800|NCT02038881|3001875|Other||GMT ratio (Group 2 [W6]/ Group 3 [W14])|0.357|||||2-Sided|95.0|0.178|0.718|||||||
1633801|NCT02038881|3001875|Other||GMT ratio (Group 1 [W6]/ Group 3 [W14)|0.281|||||2-Sided|95.0|0.146|0.542|||||||
1633802|NCT02038881|3001876|Other||GMT Ratio (Group 1+3 [pooled] / Group 2)|0.878|||||2-Sided|95.0|0.48|1.606|||||||
1633803|NCT02038881|3001877|Other||GMT Ratio (Group 3 / Group 1) at Week 6|1.215|||||2-Sided|95.0|0.612|2.412|||||||
1633804|NCT02038881|3001877|Other||GMT Ratio (Group 3 / Group 1) at Week 4|2.557|||||2-Sided|95.0|0.972|6.731|||||||
1633805|NCT02038881|3001877|Other||GMT Ratio (Group 1 / Group 2) at Week 56|0.59|||||2-Sided|95.0|0.203|1.716|||||||
1633806|NCT02038881|3001877|Other||GMT Ratio (Group 1 / Group 2) at Week 30|0.535|||||2-Sided|95.0|0.187|1.536|||||||
1633807|NCT02038881|3001877|Other||GMT Ratio (Group 1 / Group 2) at Week 6|0.787|||||2-Sided|95.0|0.41|1.508|||||||
1633808|NCT02038881|3001877|Other||GMT Ratio (Group 1 / Group 2) at Week 4|0.823|||||2-Sided|95.0|0.333|2.038|||||||
1633809|NCT02038881|3001878|Other||GMT Ratio (Group 2 [W56]/ Group 3 [W64])|0.237|||||2-Sided|95.0|0.072|0.782|||||||
1633810|NCT02038881|3001878|Other||GMT Ratio (Group 2 [W30]/ Group 3 [W38])|0.215|||||2-Sided|95.0|0.066|0.699|||||||
1633811|NCT02038881|3001878|Other||GMT Ratio (Group 3 [W64]/ Group 1 [W56])|4.608|||||2-Sided|95.0|1.365|15.558|||||||
1633812|NCT02038881|3001878|Other||GMT Ratio (Group 3 [W38]/ Group 1 [W30])|4.138|||||2-Sided|95.0|1.241|13.793|||||||
1633813|NCT02038881|3001879|Other||GMT ratio (Group 2 [W6]/ Group 3 [W14])|0.532|||||2-Sided|95.0|0.285|0.992|||||||
1633814|NCT02038881|3001879|Other||GMT Ratio (Group 1 [W6]/ Group 3 [W14)|0.347|||||2-Sided|95.0|0.2|0.603|||||||
1633815|NCT02038881|3001880|Other||GMT Ratio (Group 1+3 [pooled] / Group 2)|0.762|||||2-Sided|95.0|0.385|1.507|||||||
1633816|NCT02038881|3001881|Other||GMT Ratio (Group 3 / Group 1) at Week 6|1.315|||||2-Sided|95.0|0.598|2.892|||||||
1633817|NCT02038881|3001881|Other||GMT Ratio (Group 3 / Group 1) at Week 4|1.045|||||2-Sided|95.0|0.292|3.741|||||||
1633818|NCT02038881|3001881|Other||GMT Ratio (Group 1 / Group 2) at Week 56|0.916|||||2-Sided|95.0|0.22|3.819|||||||
1633819|NCT02038881|3001881|Other||GMT Ratio (Group 1 / Group 2) at Week 30|1.126|||||2-Sided|95.0|0.291|4.352|||||||
1633820|NCT02038881|3001881|Other||GMT Ratio (Group 1 / Group 2) at Week 6|0.653|||||2-Sided|95.0|0.319|1.333|||||||
1633821|NCT02038881|3001881|Other||GMT Ratio (Group 1 / Group 2) at Week 4|0.851|||||2-Sided|95.0|0.258|2.8|||||||
1633822|NCT02038829|3001892|Superiority|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides ~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1902|Standard Error of the Mean|0.0186|<|0.0001|2-Sided|95.0|0.1537|0.2268|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.|
1633823|NCT02038829|3001892|Superiority|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides ~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1963|Standard Error of the Mean|0.0184|<|0.0001|2-Sided|95.0|0.1601|0.2325|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.|
1633824|NCT02038829|3001892|Non-Inferiority|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides ~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1255|Standard Error of the Mean|0.0186|<|0.0001|2-Sided|95.0|0.089|0.1621|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.|
1633835|NCT02038790|3001905|Superiority or Other|||||||0.4422||||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared||||
1633825|NCT02038829|3001892|Superiority|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides ~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0842|Standard Error of the Mean|0.0185|<|0.0001|2-Sided|95.0|0.0478|0.1206|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.|
1633826|NCT02038829|3001892|Superiority|A sample size of 78 subjects (rounding to 84 for using Williams squares) provides ~80% power to detect a 55 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in AUC(0-12) of 143 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0526|Standard Error of the Mean|0.0184|<|0.0046|2-Sided|95.0|0.0163|0.0888|||LS Mean (SE)|||An mixed effects model was used with standardized FEV1 AUC(0-12) on Day 7 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.|
1633827|NCT02038829|3001893|Superiority|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides ~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1567|Standard Error of the Mean|0.0226|<|0.0001|2-Sided|95.0|0.1121|0.2012||P-values were adjusted using Dunnett’s method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.|
1633828|NCT02038829|3001893|Superiority|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides ~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1375|Standard Error of the Mean|0.0226|<|0.0001|2-Sided|95.0|0.0931|0.1818||P-values were adjusted using Dunnett’s method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation|
1633829|NCT02038829|3001893|Superiority|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides ~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.1088|Standard Error of the Mean|0.0226|<|0.0001|2-Sided|95.0|0.0644|0.1532||P-values were adjusted using Dunnett’s method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.|
1633830|NCT02038829|3001893|Superiority|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides ~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0822|Standard Error of the Mean|0.0225|<|0.0014|2-Sided|95.0|0.038|0.1264||P-values were adjusted using Dunnett’s method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.|
1633831|NCT02038829|3001893|Superiority|A sample size of 66 subjects (rounding to 72 for using Williams squares and 96 with dropouts) provides ~90% power to detect a 100 mL treatment difference in mean change trough FEV1 between SUN-101 and placebo at a Bonferroni-adjusted significance level of 0.0125 using a 2-tailed paired t-test and assuming a within-subject standard deviation for change in trough FEV1 of 176 and a within-subject correlation of 0.3.|LS Mean (SE)|0.0126|Standard Error of the Mean|0.0225|<|0.973|2-Sided|95.0|-0.0318|0.0569||P-values were adjusted using Dunnett’s method for comparing the multiple treatments to placebo. The comparison of aclidinium to placebo was performed at the 0.05 significance level to establish assay sensitivity.|LS Mean (SE)|||An mixed effects model was used with mean change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. The Kenward and Roger correction to the degrees of freedom was used. An unstructured covariance model was used to model intrasubject correlation.|
1633832|NCT02038790|3001902|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1633833|NCT02038790|3001903|Superiority or Other|||||||0.0603|||||||Chi-squared||||
1633834|NCT02038790|3001904|Superiority or Other|||||||0.2377|||||||Chi-squared||||
1633836|NCT02038790|3001906|Superiority or Other|||||||0.0006||||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared||||
1633837|NCT02038790|3001907|Superiority or Other|||||||0.0196||||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared||||
1633838|NCT02038790|3001908|Superiority or Other||||||>|0.5||||||Two-tailed level of significance of 0.05 and no adjustments made for the number of tests conducted.|Chi-squared||||
1633839|NCT02038647|3001938|Superiority||Odds Ratio (OR)|0.59||||0.077|2-Sided|95.0|0.32|1.08||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using DCR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.||
1633840|NCT02038647|3001939|Superiority||Odds Ratio (OR)|0.01||||0.283|2-Sided|95.0|0.01|9999.99||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using CRR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.||
1633841|NCT02038647|3001940|Superiority||Odds Ratio (OR)|0.74||||0.406|2-Sided|95.0|0.35|1.55||Stratification factors were disease subtypes (sensitive versus resistant/refractory), the presence of brain metastases and region.|Weighted Cochran-Mantel-Haenszel test||Logistic regression using ORR as dependent variable, treatment arm as independent variable and disease subtype (sensitive vs resistant/refractory) and presence of brain metastases as stratification factors.||
1633842|NCT02038647|3001941|Superiority||Cox Proportional Hazard|0.93||||0.714|2-Sided|95.0|0.652|1.341||P-value tests the hypothesis of equal event times in both treatment arms obtained using the Log-rank test stratified by disease subtype as sensitive versus resistant/refractory and the presence of brain metastases.|Log Rank||The stratification factors were: disease subtype as sensitive versus resistant/refractory and the presence of brain metastases (yes or no) with treatment (Alisertib + Paclitaxel vs Placebo + Paclitaxel) as a factor in the model.||
1633843|NCT02038647|3001943|Superiority||Hazard Ratio (HR)|0.77||||0.113|2-Sided|95.0|0.557|1.067||P-value tests the hypothesis of equal event times in both treatment arms obtained using the Log-rank test stratified by disease subtype as sensitive versus resistant/refractory and the presence of brain metastases.|Log Rank||The stratification factors were: disease subtype as sensitive versus resistant/refractory and the presence of brain metastases (yes or no) with treatment (Alisertib + Paclitaxel vs Placebo + Paclitaxel) as a factor in the model.||
1633844|NCT02038179|3001970|Superiority|||||||0.84|||||||paired t-test||||
1633845|NCT02038179|3001971|Superiority||||||<|0.001|||||||paired t-test||||
1633846|NCT02038179|3001972|Superiority|||||||0.83||||||Intent-to-Treat Analysis using multiple imputation. Imputed Means and Imputed Standard Errors of the Mean.|paired t-test||||
1633847|NCT02038075|3001984|Superiority or Other||Cox Proportional Hazard|0.38||||0.02|2-Sided|95.0|0.16|0.87|||Regression, Cox|||To determine the effectiveness of brief CBT compared with treatment as usual, univariate and multivariate Cox proportional hazard regression models were used to analyze time to the first suicide attempt. Time to suicide attempt was measured by calculating the total number of days from enrollment to the first suicide attempt. For participants without a suicide attempt, the total number of days from enrollment to the last assessment was calculated.|
1633848|NCT02037984|3002010|Other|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|93.8|||||2-Sided|95.0|78.5|98.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633849|NCT02037984|3002010|Other|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||2-Sided|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633850|NCT02037984|3002010|Other|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||2-Sided|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633851|NCT02037984|3002010|Other|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|-3.4|||||2-Sided|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633852|NCT02037984|3002010|Other|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|-6.9|||||2-Sided|95.0|-22.1|3.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633853|NCT02037984|3002010|Other|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|-3.4|||||2-Sided|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633854|NCT02037984|3002010|Other|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||2-Sided|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633855|NCT02037984|3002010|Other|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|-3.4|||||2-Sided|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633856|NCT02037984|3002010|Other|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||2-Sided|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633857|NCT02037984|3002010|Other|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||2-Sided|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633858|NCT02037984|3002010|Other|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||2-Sided|95.0|-11.9|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633859|NCT02037984|3002010|Other|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|-3.4|||||2-Sided|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633860|NCT02037984|3002010|Other|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-7.6|||||2-Sided|95.0|-24.2|5.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1636041|NCT01990612|3006445|Superiority||||||<|0.001|||||||Wilcoxon Rank-Sum||||
1633861|NCT02037984|3002010|Other|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|14.0|||||2-Sided|95.0|-5.5|32.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633862|NCT02037984|3002010|Other|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.4|||||2-Sided|95.0|-17.3|6.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633863|NCT02037984|3002011|Other|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||2-Sided|95.0|85.9|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633864|NCT02037984|3002011|Other|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||2-Sided|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633865|NCT02037984|3002011|Other|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|-5.9|||||2-Sided|95.0|-19.2|3.9|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633866|NCT02037984|3002011|Other|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||2-Sided|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633867|NCT02037984|3002011|Other|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||2-Sided|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633868|NCT02037984|3002011|Other|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||2-Sided|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633869|NCT02037984|3002011|Other|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||2-Sided|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633870|NCT02037984|3002011|Other|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||2-Sided|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633871|NCT02037984|3002011|Other|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||2-Sided|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633872|NCT02037984|3002011|Other|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||2-Sided|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633873|NCT02037984|3002011|Other|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||2-Sided|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633874|NCT02037984|3002011|Other|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||2-Sided|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633875|NCT02037984|3002011|Other|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-14.9|||||2-Sided|95.0|-31.4|-1.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633876|NCT02037984|3002011|Other|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|18.4|||||2-Sided|95.0|1.7|35.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633877|NCT02037984|3002011|Other|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|0.0|||||2-Sided|95.0|-10.3|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633878|NCT02037984|3002012|Other|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||2-Sided|95.0|85.7|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633879|NCT02037984|3002012|Other|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||2-Sided|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633880|NCT02037984|3002012|Other|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|-3.0|||||2-Sided|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633881|NCT02037984|3002012|Other|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||2-Sided|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633882|NCT02037984|3002012|Other|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||2-Sided|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633883|NCT02037984|3002012|Other|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||2-Sided|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633884|NCT02037984|3002012|Other|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||2-Sided|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633885|NCT02037984|3002012|Other|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||2-Sided|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633886|NCT02037984|3002012|Other|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||2-Sided|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633887|NCT02037984|3002012|Other|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|-3.0|||||2-Sided|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633888|NCT02037984|3002012|Other|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||2-Sided|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633889|NCT02037984|3002012|Other|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||2-Sided|95.0|-10.6|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633970|NCT02037984|3002021|Other|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.68|||||2-Sided|95.0|0.43|1.07|||||||
1633890|NCT02037984|3002012|Other|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|2.7|||||2-Sided|95.0|-8.0|14.0|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633891|NCT02037984|3002012|Other|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|24.3|||||2-Sided|95.0|12.6|40.2|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633892|NCT02037984|3002012|Other|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.0|||||2-Sided|95.0|-15.5|6.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633893|NCT02037984|3002013|Other|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|92.9|||||2-Sided|95.0|75.1|98.1|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633894|NCT02037984|3002013|Other|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|85.0|||||2-Sided|95.0|65.8|93.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633895|NCT02037984|3002013|Other|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||2-Sided|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633896|NCT02037984|3002013|Other|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||2-Sided|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633897|NCT02037984|3002013|Other|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||2-Sided|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633898|NCT02037984|3002013|Other|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||2-Sided|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633899|NCT02037984|3002013|Other|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||2-Sided|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633900|NCT02037984|3002013|Other|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||2-Sided|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633901|NCT02037984|3002013|Other|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||2-Sided|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633902|NCT02037984|3002013|Other|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||2-Sided|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633903|NCT02037984|3002013|Other|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||2-Sided|95.0|-14.5|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633904|NCT02037984|3002013|Other|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||2-Sided|95.0|-14.0|9.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633905|NCT02037984|3002013|Other|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-1.6|||||2-Sided|95.0|-18.8|10.3|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633906|NCT02037984|3002013|Other|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|11.8|||||2-Sided|95.0|-10.0|30.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633907|NCT02037984|3002013|Other|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-4.2|||||2-Sided|95.0|-20.4|5.6|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633908|NCT02037984|3002014|Other|non-PT33F Percentage Point Difference (V114 - Prevnar 13®)|non-PT33F Percentage Point Difference|97.3|||||2-Sided|95.0|85.1|99.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633909|NCT02037984|3002014|Other|non-PT22F Percentage Point Difference (V114 - Prevnar 13®)|non-PT22F Percentage Point Difference|89.2|||||2-Sided|95.0|75.2|95.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633910|NCT02037984|3002014|Other|PT23F Percentage Point Difference (V114 - Prevnar 13®)|PT23F Percentage Point Difference|0.0|||||2-Sided|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633911|NCT02037984|3002014|Other|PT19F Percentage Point Difference (V114 - Prevnar 13®)|PT19F Percentage Point Difference|0.0|||||2-Sided|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633912|NCT02037984|3002014|Other|PT19A Percentage Point Difference (V114 - Prevnar 13®)|PT19A Percentage Point Difference|0.0|||||2-Sided|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633913|NCT02037984|3002014|Other|PT18C Percentage Point Difference (V114 - Prevnar 13®)|PT18C Percentage Point Difference|0.0|||||2-Sided|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633914|NCT02037984|3002014|Other|PT14 Percentage Point Difference (V114 - Prevnar 13®)|PT14 Percentage Point Difference|0.0|||||2-Sided|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633915|NCT02037984|3002014|Other|PT9V Percentage Point Difference (V114 - Prevnar 13®)|PT9V Percentage Point Difference|0.0|||||2-Sided|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633916|NCT02037984|3002014|Other|PT7F Percentage Point Difference (V114 - Prevnar 13®)|PT7F Percentage Point Difference|0.0|||||2-Sided|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633917|NCT02037984|3002014|Other|PT6B Percentage Point Difference (V114 - Prevnar 13®)|PT6B Percentage Point Difference|0.0|||||2-Sided|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633918|NCT02037984|3002014|Other|PT6A Percentage Point Difference (V114 - Prevnar 13®)|PT6A Percentage Point Difference|0.0|||||2-Sided|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633919|NCT02037984|3002014|Other|PT5 Percentage Point Difference (V114 - Prevnar 13®)|PT5 Percentage Point Difference|0.0|||||2-Sided|95.0|-11.2|9.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633920|NCT02037984|3002014|Other|PT4 Percentage Point Difference (V114 - Prevnar 13®)|PT4 Percentage Point Difference|-7.0|||||2-Sided|95.0|-22.8|5.7|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633921|NCT02037984|3002014|Other|PT3 Percentage Point Difference (V114 - Prevnar 13®)|PT3 Percentage Point Difference|14.6|||||2-Sided|95.0|-4.1|32.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633922|NCT02037984|3002014|Other|PT1 Percentage Point Difference (V114 - Prevnar 13®)|PT1 Percentage Point Difference|-3.2|||||2-Sided|95.0|-16.3|6.5|||||Estimated difference and 95% CI are based on the Miettinen and Nurminen method.||
1633923|NCT02037984|3002018|Other|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|20.03|||||2-Sided|95.0|10.88|36.88|||||||
1633924|NCT02037984|3002018|Other|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|68.64|||||2-Sided|95.0|45.81|102.84|||||||
1633925|NCT02037984|3002018|Other|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.79|||||2-Sided|95.0|0.49|1.28|||||||
1633926|NCT02037984|3002018|Other|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|0.97|||||2-Sided|95.0|0.66|1.44|||||||
1633927|NCT02037984|3002018|Other|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.55|||||2-Sided|95.0|0.37|0.8|||||||
1633928|NCT02037984|3002018|Other|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.72|||||2-Sided|95.0|0.5|1.05|||||||
1633929|NCT02037984|3002018|Other|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.79|||||2-Sided|95.0|0.51|1.22|||||||
1633930|NCT02037984|3002018|Other|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.68|||||2-Sided|95.0|0.46|1.01|||||||
1633931|NCT02037984|3002018|Other|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.59|||||2-Sided|95.0|0.41|0.84|||||||
1633932|NCT02037984|3002018|Other|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.18|||||2-Sided|95.0|0.08|0.38|||||||
1633933|NCT02037984|3002018|Other|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.34|||||2-Sided|95.0|0.17|0.65|||||||
1633934|NCT02037984|3002018|Other|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.51|||||2-Sided|95.0|0.34|0.76|||||||
1633935|NCT02037984|3002018|Other|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.07|||||2-Sided|95.0|0.79|1.46|||||||
1633936|NCT02037984|3002018|Other|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.55|||||2-Sided|95.0|1.86|3.49|||||||
1633937|NCT02037984|3002018|Other|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.8|||||2-Sided|95.0|0.58|1.09|||||||
1633938|NCT02037984|3002019|Other|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|25.75|||||2-Sided|95.0|14.18|46.78|||||||
1633939|NCT02037984|3002019|Other|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|56.08|||||2-Sided|95.0|37.66|83.52|||||||
1633940|NCT02037984|3002019|Other|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.69|||||2-Sided|95.0|0.43|1.12|||||||
1633941|NCT02037984|3002019|Other|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|0.88|||||2-Sided|95.0|0.6|1.29|||||||
1633942|NCT02037984|3002019|Other|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.7|||||2-Sided|95.0|0.48|1.02|||||||
1633943|NCT02037984|3002019|Other|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.66|||||2-Sided|95.0|0.46|0.95|||||||
1633944|NCT02037984|3002019|Other|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.74|||||2-Sided|95.0|0.48|1.14|||||||
1633945|NCT02037984|3002019|Other|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.79|||||2-Sided|95.0|0.54|1.16|||||||
1633946|NCT02037984|3002019|Other|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.6|||||2-Sided|95.0|0.42|0.85|||||||
1633947|NCT02037984|3002019|Other|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.36|||||2-Sided|95.0|0.17|0.77|||||||
1633948|NCT02037984|3002019|Other|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.49|||||2-Sided|95.0|0.26|0.94|||||||
1633949|NCT02037984|3002019|Other|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.53|||||2-Sided|95.0|0.36|0.79|||||||
1633950|NCT02037984|3002019|Other|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|0.97|||||2-Sided|95.0|0.71|1.31|||||||
1633951|NCT02037984|3002019|Other|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.21|||||2-Sided|95.0|1.62|3.02|||||||
1633952|NCT02037984|3002019|Other|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.68|||||2-Sided|95.0|0.5|0.93|||||||
1633953|NCT02037984|3002020|Other|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|15.66|||||2-Sided|95.0|8.46|28.98|||||||
1633954|NCT02037984|3002020|Other|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|77.57|||||2-Sided|95.0|51.6|116.6|||||||
1633955|NCT02037984|3002020|Other|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.75|||||2-Sided|95.0|0.46|1.23|||||||
1633956|NCT02037984|3002020|Other|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.24|||||2-Sided|95.0|0.84|1.84|||||||
1633957|NCT02037984|3002020|Other|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.95|||||2-Sided|95.0|0.64|1.39|||||||
1633958|NCT02037984|3002020|Other|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.96|||||2-Sided|95.0|0.66|1.39|||||||
1633959|NCT02037984|3002020|Other|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|1.03|||||2-Sided|95.0|0.66|1.6|||||||
1633960|NCT02037984|3002020|Other|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.88|||||2-Sided|95.0|0.59|1.3|||||||
1633961|NCT02037984|3002020|Other|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.73|||||2-Sided|95.0|0.51|1.04|||||||
1633962|NCT02037984|3002020|Other|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.11|||||2-Sided|95.0|0.05|0.23|||||||
1633963|NCT02037984|3002020|Other|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.33|||||2-Sided|95.0|0.17|0.64|||||||
1633964|NCT02037984|3002020|Other|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.68|||||2-Sided|95.0|0.46|1.02|||||||
1633965|NCT02037984|3002020|Other|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.52|||||2-Sided|95.0|1.11|2.07|||||||
1633966|NCT02037984|3002020|Other|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.68|||||2-Sided|95.0|1.95|3.68|||||||
1633967|NCT02037984|3002020|Other|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.78|||||2-Sided|95.0|0.57|1.07|||||||
1633968|NCT02037984|3002021|Other|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|15.29|||||2-Sided|95.0|8.58|27.26|||||||
1633969|NCT02037984|3002021|Other|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|44.61|||||2-Sided|95.0|30.42|65.43|||||||
1633971|NCT02037984|3002021|Other|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.11|||||2-Sided|95.0|0.77|1.6|||||||
1633972|NCT02037984|3002021|Other|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.66|||||2-Sided|95.0|0.46|0.95|||||||
1633973|NCT02037984|3002021|Other|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.85|||||2-Sided|95.0|0.6|1.21|||||||
1633974|NCT02037984|3002021|Other|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.64|||||2-Sided|95.0|0.42|0.97|||||||
1633975|NCT02037984|3002021|Other|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.56|||||2-Sided|95.0|0.39|0.82|||||||
1633976|NCT02037984|3002021|Other|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.48|||||2-Sided|95.0|0.34|0.67|||||||
1633977|NCT02037984|3002021|Other|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.16|||||2-Sided|95.0|0.08|0.34|||||||
1633978|NCT02037984|3002021|Other|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.31|||||2-Sided|95.0|0.17|0.58|||||||
1633979|NCT02037984|3002021|Other|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.51|||||2-Sided|95.0|0.35|0.74|||||||
1633980|NCT02037984|3002021|Other|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|0.87|||||2-Sided|95.0|0.65|1.16|||||||
1633981|NCT02037984|3002021|Other|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|1.79|||||2-Sided|95.0|1.33|2.41|||||||
1633982|NCT02037984|3002021|Other|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.52|||||2-Sided|95.0|0.39|0.7|||||||
1633983|NCT02037984|3002022|Other|non-PT33F GMC Ratio (V114/Prevnar 13®)|non-PT33F GMC Ratio|23.9|||||2-Sided|95.0|13.21|43.24|||||||
1633984|NCT02037984|3002022|Other|non-PT22F GMC Ratio (V114/Prevnar 13®)|non-PT22F GMC Ratio|67.5|||||2-Sided|95.0|45.58|99.97|||||||
1633985|NCT02037984|3002022|Other|PT23F GMC Ratio (V114/Prevnar 13®)|PT23F GMC Ratio|0.91|||||2-Sided|95.0|0.57|1.45|||||||
1633986|NCT02037984|3002022|Other|PT19F GMC Ratio (V114/Prevnar 13®)|PT19F GMC Ratio|1.22|||||2-Sided|95.0|0.83|1.78|||||||
1633987|NCT02037984|3002022|Other|PT19A GMC Ratio (V114/Prevnar 13®)|PT19A GMC Ratio|0.88|||||2-Sided|95.0|0.61|1.27|||||||
1633988|NCT02037984|3002022|Other|PT18C GMC Ratio (V114/Prevnar 13®)|PT18C GMC Ratio|0.92|||||2-Sided|95.0|0.64|1.31|||||||
1633989|NCT02037984|3002022|Other|PT14 GMC Ratio (V114/Prevnar®)|PT9V GMC Ratio|0.59|||||2-Sided|95.0|0.39|0.9|||||||
1633990|NCT02037984|3002022|Other|PT9V GMC Ratio (V114/Prevnar 13®)|PT9V GMC Ratio|0.74|||||2-Sided|95.0|0.51|1.08|||||||
1633991|NCT02037984|3002022|Other|PT7F GMC Ratio (V114/Prevnar 13®)|PT7F GMC Ratio|0.72|||||2-Sided|95.0|0.51|1.02|||||||
1633992|NCT02037984|3002022|Other|PT6B GMC Ratio (V114/Prevnar 13®)|PT6B GMG Ratio|0.34|||||2-Sided|95.0|0.16|0.73|||||||
1633993|NCT02037984|3002022|Other|PT6A GMC Ratio (V114/Prevnar 13®)|PT6A GMC Ratio|0.6|||||2-Sided|95.0|0.32|1.13|||||||
1633994|NCT02037984|3002022|Other|PT5 GMC Ratio (V114/Prevnar 13®)|PT5 GMC Ratio|0.71|||||2-Sided|95.0|0.48|1.05|||||||
1633995|NCT02037984|3002022|Other|PT4 GMC Ratio (V114/Prevnar 13®)|PT4 GMG Ratio|1.37|||||2-Sided|95.0|1.01|1.84|||||||
1633996|NCT02037984|3002022|Other|PT3 GMC Ratio (V114/Prevnar 13®)|PT3 GMC Ratio|2.22|||||2-Sided|95.0|1.64|3.02|||||||
1633997|NCT02037984|3002022|Other|PT1 GMC Ratio (V114/Prevnar 13®)|PT1 GMC Ratio|0.81|||||2-Sided|95.0|0.6|1.1|||||||
1633998|NCT02037776|3002038|Superiority|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in anxiety point score of HAD|
1633999|NCT02037776|3002038|Superiority|||||||0.084|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in depression point score of HAD|
1634000|NCT02037776|3002038|Superiority|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in overall point score of HAD|
1634001|NCT02037776|3002039|Superiority|||||||0.342|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in MCS of SF-8|
1634002|NCT02037776|3002039|Superiority|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in PCS of SF-8|
1634003|NCT02037776|3002040|Superiority|||||||0.034|||||||Wilcoxon (Mann-Whitney)||||
1634004|NCT02037776|3002041|Superiority|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Lower Abdominal Pain of PAGI-SYM|
1634005|NCT02037776|3002041|Superiority|||||||0.245|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Upper Abdominal Pain of PAGI-SYM|
1634006|NCT02037776|3002041|Superiority|||||||0.011|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Bloating of PAGI-SYM|
1634007|NCT02037776|3002041|Superiority|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Postprandial Fullness/Early satiety of PAGI-SYM|
1634008|NCT02037776|3002041|Superiority|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Nausea/Vomiting of PAGI-SYM|
1634009|NCT02037776|3002041|Superiority|||||||0.947|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in Heartburn/Regurgitation of PAGI-SYM|
1634010|NCT02037776|3002041|Superiority|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in total score of PAGI-SYM|
1634011|NCT02037776|3002042|Superiority|||||||0.148|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in dyspeptic symptoms of modified FSSG|
1634012|NCT02037776|3002042|Superiority|||||||0.089|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in GERD symptoms of modified FSSG|
1634013|NCT02037776|3002042|Superiority|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Change from baseline in all symptoms of modified FSSG|
1634014|NCT02037776|3002043|Superiority|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups in Rikkunshito Placebo and Rikkunshito, based on the count of participants categorized in 1 (Significantly improved) through 7 (Much worse), using the Wilcoxon (Mann-Whitney).|
1634015|NCT02037568|3002045|Superiority|||||||0.86|||||||Mixed Models Analysis||||
1634016|NCT02037568|3002046|Superiority|||||||0.79|||||||Mixed Models Analysis||||
1634017|NCT02037568|3002047|Superiority|||||||0.74|||||||Mixed Models Analysis||||
1634018|NCT02037568|3002048|Superiority|||||||0.96|||||||Mixed Models Analysis||||
1634019|NCT02037568|3002049|Superiority|||||||0.07|||||||Mixed Models Analysis||||
1634020|NCT02037568|3002050|Superiority|||||||0.05|||||||Mixed Models Analysis||||
1634021|NCT02037568|3002051|Superiority|||||||0.08|||||||Mixed Models Analysis||||
1634022|NCT02037568|3002052|Superiority|||||||0.007|||||||Mixed Models Analysis||||
1634024|NCT02037438|3002060|Superiority or Other||Provider-Effect Adjusted Difference|0.177|Standard Error of the Mean|0.061||0.003|2-Sided||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers|||
1634025|NCT02037438|3002061|Superiority or Other||Provider-Effect Adjusted Difference|0.057|Standard Error of the Mean|0.078||0.468|2-Sided||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers|||
1634026|NCT02037438|3002062|Superiority or Other||Provider-Effect Adjusted Difference|0.114|Standard Error of the Mean|0.141||0.417|2-Sided||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers|||
1634027|NCT02037438|3002063|Superiority or Other||Provider-Effect Adjusted Difference|-0.007|Standard Error of the Mean|0.539||0.989|2-Sided||||||see Comments|Heteroscedasticity-Consistent Linear Regression with Fixed Effects for Providers and Baseline Covariate|||
1634028|NCT02037438|3002064|Superiority or Other||Provider-Effect Adjusted Difference|0.03|Standard Error of the Mean|0.075||0.687|2-Sided||||||see Comments|Finite-Mixture Models with Fixed Effects for Providers|||
1634029|NCT02037204|3002087|Non-Inferiority|A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.|||||<|0.05|||||||ANOVA|||A repeated-measures analysis of variance was used to test for differences in clinical outcome between baseline and 3, and 18 months after surgery.|
1634030|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-49.4|Standard Error of the Mean|26.7541|||2-Sided|95.0|-102.6|3.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634031|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-61.36|Standard Error of the Mean|27.2866|||2-Sided|95.0|-115.6|-7.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634032|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-63.69|Standard Error of the Mean|27.3484|||2-Sided|95.0|-118.1|-9.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634033|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-38.99|Standard Error of the Mean|23.4683|||2-Sided|95.0|-85.6|7.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634034|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-39.96|Standard Error of the Mean|22.9336|||2-Sided|95.0|-85.5|5.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634035|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-59.87|Standard Error of the Mean|23.0541|||2-Sided|95.0|-105.6|-14.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634036|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-52.45|Standard Error of the Mean|24.8429|||2-Sided|95.0|-101.8|-3.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634247|NCT02036515|3002149|Superiority or Other||Difference in least squares mean|-0.76|||<|0.001|2-Sided|95.0|-0.95|-0.58|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication|||
1634319|NCT02034006|3002336|Superiority or Other||Odds Ratio (OR)|72.37|||<|0.0001|2-Sided|95.0|23.44|223.42|||Regression, Logistic|||Presence vs. absence of active leakage.|
1634037|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-37.06|Standard Error of the Mean|29.5797|||2-Sided|95.0|-95.7|21.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634038|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-39.62|Standard Error of the Mean|29.3023|||2-Sided|95.0|-97.7|18.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634039|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-17.19|Standard Error of the Mean|27.0135|||2-Sided|95.0|-70.9|36.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634040|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-25.23|Standard Error of the Mean|27.5524|||2-Sided|95.0|-79.9|29.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634041|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-19.27|Standard Error of the Mean|27.6359|||2-Sided|95.0|-74.3|35.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634042|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-0.67|Standard Error of the Mean|23.7285|||2-Sided|95.0|-47.8|46.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634043|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-12.63|Standard Error of the Mean|23.1894|||2-Sided|95.0|-58.6|33.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634044|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-20.47|Standard Error of the Mean|23.311|||2-Sided|95.0|-66.7|25.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634045|NCT02037165|3002089|Superiority or Other||adjusted mean difference|7.63|Standard Error of the Mean|25.1035|||2-Sided|95.0|-42.2|57.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634203|NCT02036775|3002112|Non-Inferiority or Equivalence|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|103.39|Standard Deviation|13.52|||2-Sided|90.0|96.54|110.74|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))||
1634046|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-16.29|Standard Error of the Mean|29.8613|||2-Sided|95.0|-75.5|42.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634047|NCT02037165|3002089|Superiority or Other||adjusted mean difference|-29.67|Standard Error of the Mean|29.5691|||2-Sided|95.0|-88.3|29.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634048|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-2.04|Standard Error of the Mean|3.3835|||2-Sided|95.0|-8.8|4.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634049|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|0.54|Standard Error of the Mean|4.1389|||2-Sided|95.0|-7.7|8.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634050|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-4.21|Standard Error of the Mean|3.6602|||2-Sided|95.0|-11.5|3.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634051|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-2.27|Standard Error of the Mean|3.5708|||2-Sided|95.0|-9.4|4.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634052|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|0.27|Standard Error of the Mean|3.6471|||2-Sided|95.0|-7.0|7.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634053|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-2.91|Standard Error of the Mean|3.4569|||2-Sided|95.0|-9.8|4.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634054|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-3.27|Standard Error of the Mean|2.8811|||2-Sided|95.0|-9.0|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634204|NCT02036775|3002112|Non-Inferiority or Equivalence|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|110.68|Standard Deviation|20.42|||2-Sided|90.0|99.84|122.69|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))||
1634055|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-2.46|Standard Error of the Mean|2.4848|||2-Sided|95.0|-7.4|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634056|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-3.64|Standard Error of the Mean|2.5461|||2-Sided|95.0|-8.7|1.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634057|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-2.67|Standard Error of the Mean|3.4254|||2-Sided|95.0|-9.5|4.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634058|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-3.82|Standard Error of the Mean|4.186|||2-Sided|95.0|-12.1|4.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634059|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-3.09|Standard Error of the Mean|3.7073|||2-Sided|95.0|-10.5|4.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634060|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-4.71|Standard Error of the Mean|3.6166|||2-Sided|95.0|-11.9|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634061|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-5.24|Standard Error of the Mean|3.6922|||2-Sided|95.0|-12.6|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634062|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-6.83|Standard Error of the Mean|3.4987|||2-Sided|95.0|-13.8|0.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634063|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-6.06|Standard Error of the Mean|2.9156|||2-Sided|95.0|-11.9|-0.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634205|NCT02036645|3002118|Superiority or Other||Slope|0.96|||||2-Sided|95.0|0.65|1.27|||||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated||
1634206|NCT02036645|3002118|Superiority or Other||Slope|0.9|||||2-Sided|95.0|0.81|0.98|||||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated||
1634293|NCT02034578|3002238|Superiority or Other||Ratio of adjusted geometric means|0.953|||||2-Sided|90.0|0.873|1.04||||||B versus A|
1634064|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-4.74|Standard Error of the Mean|2.5162|||2-Sided|95.0|-9.8|0.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634065|NCT02037165|3002090|Superiority or Other||Adjusted mean difference|-3.78|Standard Error of the Mean|2.5753|||2-Sided|95.0|-8.9|1.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634066|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-3.05|Standard Error of the Mean|2.8201|||2-Sided|95.0|-8.7|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634067|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-3.84|Standard Error of the Mean|3.7013|||2-Sided|95.0|-11.2|3.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634068|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-2.59|Standard Error of the Mean|3.125|||2-Sided|95.0|-8.8|3.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634069|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-1.05|Standard Error of the Mean|2.5649|||2-Sided|95.0|-6.1|4.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634070|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-0.05|Standard Error of the Mean|3.0965|||2-Sided|95.0|-6.2|6.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634071|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-0.8|Standard Error of the Mean|3.5078|||2-Sided|95.0|-7.8|6.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634072|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-3.61|Standard Error of the Mean|3.2806|||2-Sided|95.0|-10.1|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634207|NCT02036645|3002119|Superiority or Other||Slope|1.01|||||2-Sided|95.0|0.71|1.3|||||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated||
1634208|NCT02036645|3002119|Superiority or Other||Slope|0.93|||||2-Sided|95.0|0.82|1.04|||||Since an Estimation approach was taken for the statistical analysis, no p-values were calculated||
1634209|NCT02036515|3002126|Superiority or Other||Difference in least squares means|-0.02|||||2-Sided|95.0|-0.07|0.02|||||||
1634073|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-4.22|Standard Error of the Mean|3.3457|||2-Sided|95.0|-10.9|2.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634074|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-6.91|Standard Error of the Mean|3.1527|||2-Sided|95.0|-13.2|-0.07|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634075|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-1.27|Standard Error of the Mean|2.857|||2-Sided|95.0|-7.0|4.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634076|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-2.78|Standard Error of the Mean|3.7688|||2-Sided|95.0|-10.3|4.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634077|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-2.35|Standard Error of the Mean|3.1849|||2-Sided|95.0|-8.7|4.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634078|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-1.18|Standard Error of the Mean|2.6161|||2-Sided|95.0|-6.4|4.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634079|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-4.43|Standard Error of the Mean|3.1554|||2-Sided|95.0|-10.7|1.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634080|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-1.8|Standard Error of the Mean|3.5727|||2-Sided|95.0|-8.9|5.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634081|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-6.67|Standard Error of the Mean|3.3393|||2-Sided|95.0|-13.3|0.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634210|NCT02036515|3002126|Superiority or Other||Difference in least squares means|0.0|||||2-Sided|95.0|-0.04|0.04|||||||
1634211|NCT02036515|3002127|Superiority or Other||Difference in least squares means|0.01|||||2-Sided|95.0|-0.02|0.04|||||||
1634212|NCT02036515|3002127|Superiority or Other||Difference in least squares means|-0.01|||||2-Sided|95.0|-0.04|0.02|||||||
1634213|NCT02036515|3002129|Superiority or Other||Difference in least squares means|12.86|||||2-Sided|95.0|6.54|19.18|||||||
1634082|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-3.88|Standard Error of the Mean|3.4032|||2-Sided|95.0|-10.6|2.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634083|NCT02037165|3002091|Superiority or Other||adjusted mean difference|-6.13|Standard Error of the Mean|3.2064|||2-Sided|95.0|-12.5|0.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634084|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|0.76|Standard Error of the Mean|1.0986|||2-Sided|95.0|-1.4|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634085|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-0.96|Standard Error of the Mean|1.0985|||2-Sided|95.0|-3.1|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634086|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-1.53|Standard Error of the Mean|1.0984|||2-Sided|95.0|-3.7|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634087|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-0.63|Standard Error of the Mean|1.0984|||2-Sided|95.0|-2.8|1.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634088|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-1.15|Standard Error of the Mean|1.0983|||2-Sided|95.0|-3.3|1.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634089|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-1.38|Standard Error of the Mean|1.0984|||2-Sided|95.0|-3.5|0.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634090|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-1.39|Standard Error of the Mean|1.0984|||2-Sided|95.0|-3.6|0.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634214|NCT02036515|3002129|Superiority or Other||Difference in least squares means|12.78|||||2-Sided|95.0|6.54|19.03|||||||
1634215|NCT02036515|3002130|Superiority or Other||Difference in least squares means|11.91|||||2-Sided|95.0|5.94|17.88|||||||
1634216|NCT02036515|3002130|Superiority or Other||Difference in least squares means|12.75|||||2-Sided|95.0|6.83|18.68|||||||
1634217|NCT02036515|3002134|Superiority or Other||Difference in percentage|-28.1|||||2-Sided|95.0|-37.5|-18.4|||||||
1634091|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-2.31|Standard Error of the Mean|1.0985|||2-Sided|95.0|-4.5|-0.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634092|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-0.35|Standard Error of the Mean|1.0986|||2-Sided|95.0|-2.5|1.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634093|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-0.07|Standard Error of the Mean|1.1242|||2-Sided|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634094|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-1.05|Standard Error of the Mean|1.124|||2-Sided|95.0|-3.3|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634095|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-1.5|Standard Error of the Mean|1.1238|||2-Sided|95.0|-3.7|0.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634096|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-0.08|Standard Error of the Mean|1.1236|||2-Sided|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634097|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-0.1|Standard Error of the Mean|1.1236|||2-Sided|95.0|-2.3|2.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634098|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-1.06|Standard Error of the Mean|1.1236|||2-Sided|95.0|-3.3|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634099|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-1.45|Standard Error of the Mean|1.1238|||2-Sided|95.0|-3.7|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634218|NCT02036515|3002134|Superiority or Other||Difference in percentage|-29.0|||||2-Sided|95.0|-38.3|-19.4|||||||
1634219|NCT02036515|3002135|Superiority or Other||Difference in percent|-14.4|||||2-Sided|95.0|-21.3|-8.5|||||||
1634220|NCT02036515|3002135|Superiority or Other||Difference in percent|-15.1|||||2-Sided|95.0|-21.9|-9.4|||||||
1634221|NCT02036515|3002136|Superiority or Other||Difference in least squares means|-0.85|||||2-Sided|95.0|-2.69|0.99|||||||
1634100|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-0.99|Standard Error of the Mean|1.124|||2-Sided|95.0|-3.2|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634101|NCT02037165|3002092|Superiority or Other||Adjusted mean difference|-0.53|Standard Error of the Mean|1.1242|||2-Sided|95.0|-2.7|1.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634102|NCT02037165|3002093|Superiority or Other||adjusted mean difference|-0.71|Standard Error of the Mean|1.1567|||2-Sided|95.0|-3.0|1.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634103|NCT02037165|3002093|Superiority or Other||adjusted mean difference|0.09|Standard Error of the Mean|1.1566|||2-Sided|95.0|-2.2|2.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634104|NCT02037165|3002093|Superiority or Other||adjusted mean difference|-0.76|Standard Error of the Mean|1.1565|||2-Sided|95.0|-3.0|1.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634105|NCT02037165|3002093|Superiority or Other||adjusted mean difference of 200 mg BI mi|-0.43|Standard Error of the Mean|1.1564|||2-Sided|95.0|-2.7|1.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634106|NCT02037165|3002093|Superiority or Other||adjusted mean difference|0.67|Standard Error of the Mean|1.1564|||2-Sided|95.0|-1.6|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634107|NCT02037165|3002093|Superiority or Other||adjusted mean difference|1.25|Standard Error of the Mean|1.1564|||2-Sided|95.0|-1.0|3.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634108|NCT02037165|3002093|Superiority or Other||adjusted mean difference|1.89|Standard Error of the Mean|1.1565|||2-Sided|95.0|-0.4|4.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634222|NCT02036515|3002136|Superiority or Other||Difference in least squares means|-0.99|||||2-Sided|95.0|-2.82|0.84|||||||
1634223|NCT02036515|3002137|Superiority or Other||Difference in least squares means|-1.38|||||2-Sided|95.0|-3.11|0.36|||||||
1634224|NCT02036515|3002137|Superiority or Other||Difference in least squares means|-1.24|||||2-Sided|95.0|-2.97|0.48|||||||
1636580|NCT01976988|3007737|Superiority or Other|||||||0.34|||||||Fisher Exact||||
1634109|NCT02037165|3002093|Superiority or Other||adjusted mean difference|0.52|Standard Error of the Mean|1.1566|||2-Sided|95.0|-1.8|2.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634110|NCT02037165|3002093|Superiority or Other||adjusted mean difference|-1.68|Standard Error of the Mean|1.1567|||2-Sided|95.0|-4.0|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634111|NCT02037165|3002093|Superiority or Other||adjusted mean difference|0.43|Standard Error of the Mean|1.1758|||2-Sided|95.0|-1.9|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634112|NCT02037165|3002093|Superiority or Other||adjusted mean difference|0.24|Standard Error of the Mean|1.1755|||2-Sided|95.0|-2.1|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634113|NCT02037165|3002093|Superiority or Other||adjusted mean difference|-1.43|Standard Error of the Mean|1.1752|||2-Sided|95.0|-3.7|0.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634114|NCT02037165|3002093|Superiority or Other||adjusted mean difference|-0.57|Standard Error of the Mean|1.1751|||2-Sided|95.0|-2.9|1.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634115|NCT02037165|3002093|Superiority or Other||adjusted mean difference|1.12|Standard Error of the Mean|1.175|||2-Sided|95.0|-1.2|3.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634116|NCT02037165|3002093|Superiority or Other||adjusted mean difference|1.33|Standard Error of the Mean|1.1751|||2-Sided|95.0|-1.0|3.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634117|NCT02037165|3002093|Superiority or Other||adjusted mean difference|2.06|Standard Error of the Mean|0.1752|||2-Sided|95.0|-0.2|4.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634225|NCT02036515|3002138|Superiority or Other||Difference in least squares means|-4.92|||||2-Sided|95.0|-7.76|-2.07|||||||
1634226|NCT02036515|3002138|Superiority or Other||Difference in least squares means|-4.99|||||2-Sided|95.0|-7.82|-2.15|||||||
1634227|NCT02036515|3002139|Superiority or Other||Odds Ratio (OR)|4.02|||||2-Sided|95.0|2.22|7.28|||||||
1634228|NCT02036515|3002139|Superiority or Other||Odds Ratio (OR)|3.63|||||2-Sided|95.0|1.98|6.64|||||||
1634118|NCT02037165|3002093|Superiority or Other||adjusted mean difference|0.51|Standard Error of the Mean|1.1755|||2-Sided|95.0|-1.8|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634119|NCT02037165|3002093|Superiority or Other||adjusted mean difference|0.79|Standard Error of the Mean|1.1758|||2-Sided|95.0|-1.5|3.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634120|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|-1.18|Standard Error of the Mean|1.2344|||2-Sided|95.0|-3.6|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634121|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|-1.71|Standard Error of the Mean|1.2343|||2-Sided|95.0|-4.1|0.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634122|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|0.13|Standard Error of the Mean|1.2343|||2-Sided|95.0|-2.3|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634123|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|0.42|Standard Error of the Mean|1.2343|||2-Sided|95.0|-2.0|2.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634124|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|-0.72|Standard Error of the Mean|1.2343|||2-Sided|95.0|-3.1|1.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634125|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|0.09|Standard Error of the Mean|1.2343|||2-Sided|95.0|-2.3|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634126|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|-1.16|Standard Error of the Mean|1.2343|||2-Sided|95.0|-3.6|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634229|NCT02036515|3002140|Superiority or Other||Difference in least squares means|-1.88|||||2-Sided|95.0|-2.81|-0.95|||||||
1634230|NCT02036515|3002140|Superiority or Other||Difference in least squares means|-2.51|||||2-Sided|95.0|-3.43|-1.59|||||||
1634231|NCT02036515|3002141|Superiority or Other||Difference in least squares means|-29.58|||||2-Sided|95.0|-37.3|-21.85|||||||
1634232|NCT02036515|3002141|Superiority or Other||Difference in least squares means|-28.76|||||2-Sided|95.0|-36.44|-21.09|||||||
1634127|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|-1.89|Standard Error of the Mean|1.2343|||2-Sided|95.0|-4.3|0.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634128|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|-1.29|Standard Error of the Mean|1.2344|||2-Sided|95.0|-3.7|1.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634129|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|-1.12|Standard Error of the Mean|1.2419|||2-Sided|95.0|-3.6|1.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634130|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|-0.54|Standard Error of the Mean|1.2418|||2-Sided|95.0|-3.0|1.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634131|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|0.11|Standard Error of the Mean|1.2418|||2-Sided|95.0|-2.3|2.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634132|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|0.39|Standard Error of the Mean|1.2418|||2-Sided|95.0|-2.1|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634133|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|0.29|Standard Error of the Mean|1.2418|||2-Sided|95.0|-2.1|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634134|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|-0.55|Standard Error of the Mean|1.2418|||2-Sided|95.0|-3.0|1.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634135|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|-1.64|Standard Error of the Mean|1.2418|||2-Sided|95.0|-4.1|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634233|NCT02036515|3002142|Superiority or Other||Difference in least squares means|-0.83|||||2-Sided|95.0|-1.05|-0.61|||||||
1634234|NCT02036515|3002142|Superiority or Other||Difference in least squares means|-0.76|||||2-Sided|95.0|-0.98|-0.54|||||||
1634235|NCT02036515|3002143|Superiority or Other||Difference in least squares means|-3.94||||0.002|2-Sided|95.0|-6.39|-1.5|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication|||
1634136|NCT02037165|3002094|Superiority or Other||Adjusted mean difference|-1.97|Standard Error of the Mean|1.2418|||2-Sided|95.0|-4.4|0.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634137|NCT02037165|3002094|Superiority or Other||adjusted mean difference|-0.96|Standard Error of the Mean|1.2419|||2-Sided|95.0|-3.4|1.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634138|NCT02037165|3002095|Superiority or Other||adjusted mean difference|-0.26|Standard Error of the Mean|1.3254|||2-Sided|95.0|-2.9|2.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634139|NCT02037165|3002095|Superiority or Other||adjusted mean difference|0.4|Standard Error of the Mean|1.3253|||2-Sided|95.0|-2.2|3.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634140|NCT02037165|3002095|Superiority or Other||adjusted mean difference|-2.05|Standard Error of the Mean|1.3253|||2-Sided|95.0|-4.7|0.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634141|NCT02037165|3002095|Superiority or Other||adjusted mean difference|-0.04|Standard Error of the Mean|1.3253|||2-Sided|95.0|-2.6|2.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634142|NCT02037165|3002095|Superiority or Other||adjusted mean difference|0.56|Standard Error of the Mean|1.3254|||2-Sided|95.0|-2.0|3.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634143|NCT02037165|3002095|Superiority or Other||adjusted mean difference|-1.32|Standard Error of the Mean|1.3253|||2-Sided|95.0|-3.9|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634144|NCT02037165|3002095|Superiority or Other||adjusted mean difference|0.82|Standard Error of the Mean|1.3253|||2-Sided|95.0|-1.8|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634236|NCT02036515|3002143|Superiority or Other||Difference in least squares means|-2.93||||0.019|2-Sided|95.0|-5.36|-0.49|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication|||
1634294|NCT02034565|3002242|Superiority or Other||Ratio of adjusted geometric means|1.043|||||2-Sided|90.0|0.933|1.167|||||||
1634295|NCT02034565|3002243|Superiority or Other||Ratio of adjusted geometric means|1.05|||||2-Sided|90.0|0.938|1.176|||||||
1634145|NCT02037165|3002095|Superiority or Other||adjusted mean difference|1.07|Standard Error of the Mean|1.3253|||2-Sided|95.0|-1.5|3.7|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634146|NCT02037165|3002095|Superiority or Other||adjusted mean difference|-1.64|Standard Error of the Mean|1.3254|||2-Sided|95.0|-4.2|1.0|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634147|NCT02037165|3002095|Superiority or Other||adjusted mean difference|-0.83|Standard Error of the Mean|1.3652|||2-Sided|95.0|-3.5|1.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634148|NCT02037165|3002095|Superiority or Other||adjusted mean difference|-1.51|Standard Error of the Mean|1.3652|||2-Sided|95.0|-4.2|1.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634149|NCT02037165|3002095|Superiority or Other||adjusted mean difference|-1.58|Standard Error of the Mean|1.3652|||2-Sided|95.0|-4.3|1.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634150|NCT02037165|3002095|Superiority or Other||adjusted mean difference|0.36|Standard Error of the Mean|1.3652|||2-Sided|95.0|-2.3|3.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634151|NCT02037165|3002095|Superiority or Other||adjusted mean difference|0.71|Standard Error of the Mean|1.3652|||2-Sided|95.0|-2.0|3.4|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634152|NCT02037165|3002095|Superiority or Other||adjusted mean difference|1.26|Standard Error of the Mean|1.3652|||2-Sided|95.0|-1.4|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634153|NCT02037165|3002095|Superiority or Other||adjusted mean difference|1.01|Standard Error of the Mean|1.3652|||2-Sided|95.0|-1.7|3.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634237|NCT02036515|3002144|Superiority or Other||Difference in least squares means|4.43|||<|0.001|2-Sided|95.0|2.44|8.02|||Regression, Logistic|Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.|||
1634238|NCT02036515|3002144|Superiority or Other||Odds Ratio (OR)|3.16|||<|0.001|2-Sided|95.0|1.74|5.72|||Regression, Logistic|Logistic regression model fitted with terms for treatment, baseline A1C, baseline eGFR and prior antihyperglycemic medication.|||
1634154|NCT02037165|3002095|Superiority or Other||adjusted mean difference|2.18|Standard Error of the Mean|1.3652|||2-Sided|95.0|-0.5|4.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634155|NCT02037165|3002095|Superiority or Other||adjusted mean difference|-0.16|Standard Error of the Mean|1.3652|||2-Sided|95.0|-2.8|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634156|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-0.31|Standard Error of the Mean|1.8257|||2-Sided|95.0|-3.9|3.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634157|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-2.65|Standard Error of the Mean|1.8254|||2-Sided|95.0|-6.2|0.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634158|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-1.46|Standard Error of the Mean|1.8252|||2-Sided|95.0|-5.0|2.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634159|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-0.23|Standard Error of the Mean|1.8251|||2-Sided|95.0|-3.8|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634160|NCT02037165|3002096|Superiority or Other||Slope|-1.72|Standard Error of the Mean|1.825|||2-Sided|95.0|-5.3|1.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634161|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-1.29|Standard Error of the Mean|1.8251|||2-Sided|95.0|-4.9|2.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634162|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-2.43|Standard Error of the Mean|1.8252|||2-Sided|95.0|-6.0|1.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634239|NCT02036515|3002145|Superiority or Other||Difference in least squares means|-1.72|||<|0.001|2-Sided|95.0|-2.35|-1.09|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication|||
1634296|NCT02034565|3002244|Superiority or Other||Ratio of Adjusted Geometric Means|0.977|||||2-Sided|90.0|0.756|1.261|||||||
1634320|NCT02033993|3002338|Superiority||Hazard Ratio (HR)|0.83||||0.54|2-Sided|95.0|0.46|1.51|||Log Rank||||
1634163|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-3.98|Standard Error of the Mean|1.8254|||2-Sided|95.0|-7.6|-0.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634164|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-1.1|Standard Error of the Mean|1.8257|||2-Sided|95.0|-4.7|2.5|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634165|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-0.84|Standard Error of the Mean|1.8566|||2-Sided|95.0|-4.5|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634166|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-1.34|Standard Error of the Mean|1.856|||2-Sided|95.0|-5.0|2.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634167|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-1.19|Standard Error of the Mean|1.8557|||2-Sided|95.0|-4.8|2.5|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634168|NCT02037165|3002096|Superiority or Other||adjusted mean difference|0.66|Standard Error of the Mean|1.8555|||2-Sided|95.0|-3.0|4.3|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634169|NCT02037165|3002096|Superiority or Other||adjusted mean difference|0.11|Standard Error of the Mean|1.8554|||2-Sided|95.0|-3.5|3.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634170|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-1.63|Standard Error of the Mean|1.8555|||2-Sided|95.0|-5.3|2.0|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634171|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-3.08|Standard Error of the Mean|1.8557|||2-Sided|95.0|-6.7|0.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634240|NCT02036515|3002145|Superiority or Other||Difference in least squares means|-2.03|||<|0.001|2-Sided|95.0|-2.65|-1.4|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication|||
1634317|NCT02034006|3002329|Superiority or Other||Odds Ratio (OR)|12.66|||<|0.0001|2-Sided|95.0|3.76|42.67|||Regression, Logistic|||Presence vs. absence of cysts.|
1634172|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-2.87|Standard Error of the Mean|1.856|||2-Sided|95.0|-6.5|0.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634173|NCT02037165|3002096|Superiority or Other||adjusted mean difference|-0.94|Standard Error of the Mean|1.8566|||2-Sided|95.0|-4.6|2.7|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634174|NCT02037165|3002097|Superiority or Other||adjusted mean difference|-1.04|Standard Error of the Mean|2.0282|||2-Sided|95.0|-5.0|2.9|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634175|NCT02037165|3002097|Superiority or Other||adjusted mean difference|0.43|Standard Error of the Mean|2.0279|||2-Sided|95.0|-3.6|4.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634176|NCT02037165|3002097|Superiority or Other||adjusted mean difference|-2.88|Standard Error of the Mean|2.0278|||2-Sided|95.0|-6.9|1.1|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634177|NCT02037165|3002097|Superiority or Other||adjusted mean difference|-0.59|Standard Error of the Mean|2.0277|||2-Sided|95.0|-4.6|3.4|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634178|NCT02037165|3002097|Superiority or Other||adjusted mean difference|1.2|Standard Error of the Mean|2.0276|||2-Sided|95.0|-2.8|5.2|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634179|NCT02037165|3002097|Superiority or Other||adjusted mean difference|-0.17|Standard Error of the Mean|2.0277|||2-Sided|95.0|-4.2|3.8|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634180|NCT02037165|3002097|Superiority or Other||adjusted mean difference|2.63|Standard Error of the Mean|2.0278|||2-Sided|95.0|-1.4|6.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634241|NCT02036515|3002146|Superiority or Other||Difference in least squares means|-31.28|||<|0.001|2-Sided|95.0|-38.9|-23.66|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication|||
1634318|NCT02034006|3002330|Superiority or Other||Odds Ratio (OR)|9.33|||<|0.0001|2-Sided|95.0|3.18|27.36|||Regression, Logistic|||Presence vs. absence of macular edema.|
1634181|NCT02037165|3002097|Superiority or Other||adjusted mean difference|1.58|Standard Error of the Mean|2.0279|||2-Sided|95.0|-2.4|5.6|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634182|NCT02037165|3002097|Superiority or Other||Adjusted mean difference|-2.68|Standard Error of the Mean|2.0282|||2-Sided|95.0|-6.7|1.3|||||Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634183|NCT02037165|3002097|Superiority or Other||adjusted mean difference|-0.15|Standard Error of the Mean|2.0801|||2-Sided|95.0|-4.2|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634184|NCT02037165|3002097|Superiority or Other||adjusted mean difference|-1.31|Standard Error of the Mean|2.0796|||2-Sided|95.0|-5.4|2.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634185|NCT02037165|3002097|Superiority or Other||adjusted mean difference|-3.15|Standard Error of the Mean|2.0792|||2-Sided|95.0|-7.2|0.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634186|NCT02037165|3002097|Superiority or Other||adjusted mean difference|-0.15|Standard Error of the Mean|2.079|||2-Sided|95.0|-4.2|3.9|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634187|NCT02037165|3002097|Superiority or Other||adjusted mean difference|1.72|Standard Error of the Mean|2.0789|||2-Sided|95.0|-2.4|5.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634188|NCT02037165|3002097|Superiority or Other||adjusted mean difference|2.53|Standard Error of the Mean|2.079|||2-Sided|95.0|-1.6|6.6|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634189|NCT02037165|3002097|Superiority or Other||adjusted mean difference|3.0|Standard Error of the Mean|2.0792|||2-Sided|95.0|-1.1|7.1|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634242|NCT02036515|3002146|Superiority or Other||Differenc in least squares means|-25.15|||<|0.001|2-Sided|95.0|-32.76|-17.54|||cLDA|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication|||
1634243|NCT02036515|3002147|Superiority or Other||Difference in percentage|0.0|||||2-Sided|95.0|-4.9|4.9|||||||
1634244|NCT02036515|3002147|Superiority or Other||Difference in percentage|0.6|||||2-Sided|95.0|-4.4|5.6|||||||
1634190|NCT02037165|3002097|Superiority or Other||adjusted mean difference|2.66|Standard Error of the Mean|2.0796|||2-Sided|95.0|-1.4|6.8|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634191|NCT02037165|3002097|Superiority or Other||adjusted mean difference|1.12|Standard Error of the Mean|2.0801|||2-Sided|95.0|-3.0|5.2|||||Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration.|A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.|
1634192|NCT02037061|3002100|Other|||||||0.83|||||||t-test, 2 sided||||
1634193|NCT02036775|3002109|Non-Inferiority or Equivalence|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|75.69|Standard Deviation|15.64|||2-Sided|90.0|69.92|81.93|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))||
1634194|NCT02036775|3002109|Non-Inferiority or Equivalence|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|100.46|Standard Deviation|11.65|||2-Sided|90.0|94.69|106.58|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))||
1634195|NCT02036775|3002109|Non-Inferiority or Equivalence|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the rate of absorption at steady state (Cmax ss/AUCss 0-24) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|76.55|Standard Deviation|14.55|||2-Sided|90.0|71.1|82.4|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))||
1634196|NCT02036775|3002110|Non-Inferiority or Equivalence|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|85.55|Standard Deviation|12.65|||2-Sided|90.0|80.23|91.22|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))||
1634197|NCT02036775|3002110|Non-Inferiority or Equivalence|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|103.39|Standard Deviation|13.52|||2-Sided|90.0|96.54|110.74|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))||
1634198|NCT02036775|3002110|Non-Inferiority or Equivalence|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) for the dose-adjusted total exposure (AUCss 0-24 norm) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|88.54|Standard Deviation|20.42|||2-Sided|90.0|79.87|98.15|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))||
1634199|NCT02036775|3002111|Non-Inferiority or Equivalence|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|80.94|Standard Deviation|17.95|||2-Sided|90.0|73.92|88.62|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))||
1634200|NCT02036775|3002111|Non-Inferiority or Equivalence|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|103.87|Standard Deviation|17.19|||2-Sided|90.0|95.22|113.31|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))||
1634201|NCT02036775|3002111|Non-Inferiority or Equivalence|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the peak concentration (Cmax ss) using an acceptance range of 75%-133%.|Adjusted Geometric Mean Ratio (%)|84.72|Standard Deviation|19.01|||2-Sided|90.0|76.96|93.25|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))||
1634202|NCT02036775|3002112|Non-Inferiority or Equivalence|The assessment of relative bioavailability without molar mass adjustment (dose adjustment) was based upon two-sided 90% confidence intervals (CIs) for the ratios of the geometric means (test divided by reference) of the area under the curve (AUCss 0-24) using an acceptance range of 80%-125%.|Adjusted Geometric Mean Ratio (%)|106.93|Standard Deviation|12.65|||2-Sided|90.0|100.29|114.02|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV(%))||
1634245|NCT02036515|3002148|Superiority or Other||Difference in percentage|-3.3|||||2-Sided|95.0|-14.1|7.6|||||||
1634246|NCT02036515|3002148|Superiority or Other||Difference in percentage|-5.7|||||2-Sided|95.0|-16.5|5.2|||||||
1634248|NCT02036515|3002149|Superiority or Other||Difference in least squares mean|-0.69|||<|0.001|2-Sided|95.0|-0.87|-0.5|||Constrained longitudinal data analysis|Model is fitted with effects for treatment, time, interaction of time by treatment, effects for baseline eGFR and prior antihyperglycemic medication|||
1634249|NCT02035696|3002176|Superiority or Other||Desirability Index Score|0.0|||||2-Sided||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.||
1634250|NCT02035696|3002176|Superiority or Other||Desirability Index Score|0.0|||||2-Sided||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.||
1634251|NCT02035696|3002176|Superiority or Other||Desirability Index Score|0.0|||||2-Sided||||||||Desirability Score: If this difference is negative, then it is defined as non-desirable (D equal to 0), while if the difference is positive, then D will equal to the relative reduction calculated in the following way: D = (TIVe - TIVc Dose )/TIVe.||
1634252|NCT02035696|3002177|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-18.0|||||2-Sided|95.0|-27.8|-7.2||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B|
1634253|NCT02035696|3002177|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-6.0|||||2-Sided|95.0|-13.4|1.3||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2|
1634254|NCT02035696|3002177|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|6.0|||||2-Sided|95.0|-4.2|15.4||||||Non-inferiority of immune responses of TIVc- Half Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1|
1634255|NCT02035696|3002177|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|-11.0|||||2-Sided|95.0|-20.5|-1.0||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B|
1634256|NCT02035696|3002177|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group differences|-3.0|||||2-Sided|95.0|-9.5|4.1||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2|
1634257|NCT02035696|3002177|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|7.0|||||2-Sided|95.0|-2.5|16.8||||||Non-inferiority of immune responses of TIVc-Full Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1|
1634258|NCT02035696|3002177|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group differences|-11.0|||||2-Sided|95.0|-21.1|-1.5||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain B|
1634259|NCT02035696|3002177|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|2.0|||||2-Sided|95.0|-4.0|8.0||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H3N2|
1634260|NCT02035696|3002177|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI on the difference between seroconversion rates ≥ -10%|Vaccine Group Differences|10.0|||||2-Sided|95.0|0.0|18.9||||||Non-inferiority of immune responses of TIVc-High Dose to TIVe, assessed in terms of Vaccine Group Differences with seroconversion against influenza strain A/H1N1|
1634261|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.57|||||2-Sided|95.0|0.44|0.75||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50|
1634262|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.94|||||2-Sided|95.0|0.87|1.02||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1|
1634263|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|0.46|||||2-Sided|95.0|0.38|0.57||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50|
1634264|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.74|||||2-Sided|95.0|0.47|1.17||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1|
1634265|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|1.62|||||2-Sided|95.0|1.14|2.3||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50|
1634266|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.02|||||2-Sided|95.0|0.66|1.58||||||Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1|
1634267|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.64|||||2-Sided|95.0|0.49|0.84||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50|
1634268|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 1|0.96|||||2-Sided|95.0|0.89|1.04||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1|
1634269|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.64|||||2-Sided|95.0|0.52|0.78||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50|
1634270|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.52|||||2-Sided|95.0|0.33|0.81||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1|
1634271|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|1.6|||||2-Sided|95.0|1.13|2.28||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50|
1634272|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.27|||||2-Sided|95.0|0.83|1.96||||||Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1|
1634273|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|0.78|||||2-Sided|95.0|0.6|1.01||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50|
1634274|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|1.0|||||2-Sided|95.0|0.92|1.08||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1|
1634275|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 50|0.71|||||2-Sided|95.0|0.58|0.87||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50|
1634276|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 1|0.68|||||2-Sided|95.0|0.43|1.06||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1|
1634277|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group ratios at Day 50|2.11|||||2-Sided|95.0|1.5|2.98||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50|
1634278|NCT02035696|3002178|Non-Inferiority or Equivalence|Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67|Vaccine Group Ratios at Day 1|0.99|||||2-Sided|95.0|0.65|1.52||||||Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1|
1634279|NCT02035553|3002179|Superiority||Diff in MMRM LSM|-1.84||||0.0451|2-Sided|95.0|-3.64|-0.04|||Mixed Models Analysis||||
1634280|NCT02035475|3002181|Superiority or Other|||||||0.412|||||||McNemar|||The null hypothesis is that there is no difference in the incidence of detected lymphoceles whether the EndoWrist 1 Vessel Sealer or the Fenestrated Maryland BiPolar Instrument were used.|
1634281|NCT02034799|3002222|Non-Inferiority or Equivalence|The assumed proportion of success for SOC is 0.95 and the proportion of success for the Bioseal group at which the power is calculated is 0.95. A sample size of 112 subjects per group achieves 80% power to detect the non-inferiority margin difference between the group proportions of -0.10. One-sided significance level of 0.025 was used. Using drop-out rate of 10%, 125 subjects per treatment group were randomized for a total of 250 subjects.|Risk Difference (RD)|0.0781|||||2-Sided|95.0|-0.048|0.199||||||H0: Delta </= -0.1 HA: Delta > -0.1 Delta is difference in proportion of successes between Bioseal and SOC gropus (Bioseal minus SOC). Success is defined as hemostasis at the TBS at 6 minutes following treatment application|
1634282|NCT02034591|3002226|Superiority or Other||Ratio of adjusted geometric means|0.947|||||2-Sided|90.0|0.903|0.994|||||||
1634283|NCT02034591|3002227|Superiority or Other||Ratio of Adjusted Geometric Means|0.95|||||2-Sided|90.0|0.905|0.997|||||||
1634284|NCT02034591|3002228|Superiority or Other||Ratio of Adjusted Geometric Means|0.884|||||2-Sided|90.0|0.83|0.942|||||||
1634285|NCT02034591|3002229|Superiority or Other||Ratio of Adjusted Geometric Means|0.81|||||2-Sided|90.0|0.764|0.86|||||||
1634286|NCT02034591|3002230|Superiority or Other||Ratio of Adjusted Geometric Means|0.813|||||2-Sided|90.0|0.766|0.863|||||||
1634287|NCT02034591|3002231|Superiority or Other||Ratio of Adjusted Geometric Means|0.682|||||2-Sided|90.0|0.621|0.748|||||||
1634288|NCT02034578|3002235|Superiority or Other||Ratio of adjusted geometric means|0.922|||||2-Sided|90.0|0.899|0.947||||||C versus A|
1634289|NCT02034578|3002235|Superiority or Other||Ratio of adjusted geometric means|0.968|||||2-Sided|90.0|0.926|1.011||||||B versus A|
1634290|NCT02034578|3002236|Superiority or Other||Ratio of adjusted geometric means|0.919|||||2-Sided|90.0|0.896|0.942||||||C versus A|
1634291|NCT02034578|3002236|Superiority or Other||Ratio of adjusted geometric means|0.966|||||2-Sided|90.0|0.924|1.01||||||B versus A|
1634292|NCT02034578|3002238|Superiority or Other||Ratio of adjusted geometric means|0.805|||||2-Sided|90.0|0.749|0.865||||||C versus A|
1634297|NCT02034552|3002252|Superiority||||||<|0.0001||||||[80% CI]: [31.8% - 68.2%]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.|
1634298|NCT02034552|3002252|Superiority||||||<|0.0001||||||[80% CI]: [40.8% - 73.7%]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.|
1634299|NCT02034552|3002252|Superiority||||||<|0.0109||||||[80% CI]: [10.1%- 39.6%]|Clopper and Pearson|Patient bone scan response rate at Week 24 will be estimated with exact binomial 80% CI using the method of Clopper and Pearson.||H0: Patient bone scan response rate at Week 24 ≤5%. The Type I error rate for the test in each treatment group, is one-sided 0.10. A one-sided p-value will be reported for this test.|
1634300|NCT02034513|3002254|Non-Inferiority or Equivalence|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%. Comparison groups: IDeg versus IGlar. Number of subjects included in analysis is 410 (n=202 for IDeg and n=208 for IGlar).|Treatment contrast|0.11|||||2-Sided|95.0|0.0|0.23||||||Change from baseline in HbA1c at week 64 (treatment period 2). The baseline values are week 32 values. Before the primary endpoint was tested, the secondary supportive efficacy endpoint “Change from baseline in HbA1c after 32 weeks of treatment” was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was based on MMRM; treatment, sex, region, pre-trial insulin treatment regimen, visit and dosing time were fixed effects, and age and baseline HbA1c were covariates|
1634301|NCT02034513|3002254|Non-Inferiority or Equivalence|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%. Comparison groups: IDeg versus IGlar. Number of subjects included in analysis is 437 (n=220 for IDeg and n=217 for IGlar).|Treatment contrast|0.03|||||2-Sided|95.0|-0.1|0.15||||||Change from baseline in HbA1c at week 32 (treatment period 1). Before testing the primary endpoint, the secondary supportive efficacy endpoint “Change from baseline in HbA1c after 32 weeks of treatment” was tested for non-inferiority as a prerequisite for testing the primary endpoint. Analysis was based on mixed model for repeated measurement (MMRM); treatment, sex, region, pre-trial insulin treatment regimen, visit and dosing time were fixed effects, and age and baseline HbA1c were covariates.|
1634302|NCT02034513|3002256|Superiority or Other|||||||0.0016||||||Superiority was confirmed if the p-value was less than 0.025.|McNemar|||Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in both the maintenance periods. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 3: Proportion of subjects with one or more severe hypoglycaemic episodes during the maintenance period.|
1634303|NCT02034513|3002257|Non-Inferiority or Equivalence|Non-inferiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was ≤1.10 or equivalently if the p-value for the 1-sided test of H0: RR >1.10 against HA: RR ≤1.10 was less than 2.5%, where RR is the estimated rate ratio IDeg/IGlar.|Treatment ratio|0.64|||<|0.0001|2-Sided|95.0|0.56|0.73|||Poisson||If non-inferiority was confirmed the superiority of IDeg/IGlar was investigated outside of the test hierarchy. Superiority was considered confirmed if the upper bound of the 2-sided 95% confidence interval was <1.00.|Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in at least one maintenance period. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 2: Number of treatment-emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes during the maintenance period.|
1634304|NCT02034513|3002258|Non-Inferiority or Equivalence|Non-inferiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was ≤1.10 or equivalently if the p-value for the 1-sided test of H0: RR >1.10 against HA: RR ≤1.10 was less than 2.5%, where RR is the estimated rate ratio IDeg/IGlar.|Treatment ratio|0.89|||<|0.0001|2-Sided|95.0|0.85|0.94|||Poisson||If non-inferiority was confirmed the superiority of IDeg/IGlar was investigated outside of the test hierarchy. Superiority was considered confirmed if the upper bound of the 2-sided 95% confidence interval was <1.00.|Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in at least one maintenance period. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 1: Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period.|
1634305|NCT02034162|3002269|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1634306|NCT02034162|3002270|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1634307|NCT02034162|3002272|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1634308|NCT02034162|3002273|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1634309|NCT02034006|3002321|Superiority or Other||Odds Ratio (OR)|5.53||||0.0461|2-Sided|95.0|0.69|44.52|||Regression, Logistic|||Change from baseline in BCVA: Worsened vs. No change|
1634310|NCT02034006|3002321|Superiority or Other||Odds Ratio (OR)|0.47||||0.0049|2-Sided|95.0|0.25|0.91|||Regression, Logistic|||Change from baseline in BCVA: Improved vs. No change. For retreated subjects, the last scheduled assessment prior to the first retreatment was considered. For subjects treated only once, the last scheduled assessment available was considered.|
1634311|NCT02034006|3002322|Superiority or Other||Odds Ratio (OR)|2.52||||0.0114|2-Sided|95.0|1.23|5.17|||Regression, Logistic|||Gain < 10 letters vs. Gain >= 10 letters.|
1634312|NCT02034006|3002323|Superiority or Other||Odds Ratio (OR)|2.19||||0.0854|2-Sided|95.0|0.9|5.33|||Regression, Logistic|||Gain < 5 letters vs. Gain >= 5 letters.|
1634313|NCT02034006|3002324|Superiority or Other||Odds Ratio (OR)|6.91||||0.0103|2-Sided|95.0|1.58|30.23|||Regression, Logistic|||Presence vs. absence of clinically significant abnormalities.|
1634314|NCT02034006|3002326|Superiority or Other||Odds Ratio (OR)|0.0||||0.1265|2-Sided|95.0|0.0|5.63|||Regression, Logistic|||Change in Central subfield volume vs previous visit.|
1634315|NCT02034006|3002327|Superiority or Other||Odds Ratio (OR)|1.0||||0.1514|2-Sided|95.0|0.99|1.0|||Regression, Logistic|||Change in Central subfield thickness vs previous visit.|
1634316|NCT02034006|3002328|Superiority or Other||Odds Ratio (OR)|49.8|||<|0.0001|2-Sided|95.0|11.62|213.5|||Regression, Logistic|||Presence vs. absence of intra-retinal fluid.|
1634321|NCT02033993|3002339|Superiority||Odds Ratio (OR)|1.41||||0.28|2-Sided|95.0|0.76|2.59|||Cochran-Mantel-Haenszel||||
1634322|NCT02033993|3002340|Superiority||Hazard Ratio (HR)|0.95||||0.4|2-Sided|90.0|0.7|1.3||1-sided p-value|Log Rank||||
1634323|NCT02033993|3002341|Superiority||Hazard Ratio (HR)|0.92||||0.31|2-Sided|90.0|0.68|1.23||1-sided p-value|Log Rank||||
1634324|NCT02033889|3002345|Other||Difference in the Least Squares Means|0.18|||||2-Sided|95.0|-0.5|0.85|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634325|NCT02033889|3002345|Other||Difference in the Least Squares Means|-0.06|||||2-Sided|95.0|-0.77|0.65|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634326|NCT02033889|3002346|Other||Difference in the least Squares Means|-0.54|||||2-Sided|95.0|-1.12|0.05|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634327|NCT02033889|3002346|Other||Difference in the Least Squares Means|-0.84|||||2-Sided|95.0|-1.44|-0.24|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634328|NCT02033889|3002347|Other||Difference in the Least Squares Means|0.12|||||2-Sided|95.0|-0.7|0.93|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634329|NCT02033889|3002347|Other||Difference in the Least Squares Means|0.27|||||2-Sided|95.0|-0.58|1.13|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634330|NCT02033889|3002348|Other||Difference in the Least Squares Means|-0.28|||||2-Sided|97.0|-1.06|0.5|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634331|NCT02033889|3002348|Other||Difference in the Least Squares Means|-0.23|||||2-Sided|95.0|-1.01|0.56|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634332|NCT02033889|3002352|Other||Difference in the Least Squares Means|-0.15|||||2-Sided|95.0|-0.78|0.49|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634333|NCT02033889|3002352|Other||Difference in the Least Squares Means|0.06|||||2-Sided|95.0|-0.61|0.72|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634334|NCT02033889|3002353|Other||Difference in the Least Squares Means|-0.22|||||2-Sided|95.0|-0.66|0.23|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634335|NCT02033889|3002353|Other||Difference in the Least Squares Means|-0.5|||||2-Sided|95.0|-0.95|-0.04|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634336|NCT02033889|3002354|Other||Difference in the Least Squares Means|0.2|||||2-Sided|95.0|-0.51|0.91|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634337|NCT02033889|3002354|Other||Difference in the Least Squares Means|0.25|||||2-Sided|95.0|-0.48|0.98|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634338|NCT02033889|3002355|Other||Difference in the Least Squares Means|-0.18|||||2-Sided|97.0|-0.88|0.51|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634339|NCT02033889|3002355|Other||Difference in the Least Squares Means|0.17|||||2-Sided|95.0|-0.53|0.88|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634340|NCT02033889|3002359|Other||Difference in the Least Squares Means|-0.21|||||2-Sided|95.0|-0.78|0.35|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634341|NCT02033889|3002359|Other||Difference in the Least Squares Means|-0.19|||||2-Sided|95.0|-0.76|0.39|||||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634342|NCT02033889|3002360|Other||Difference in the Least Squares Means|0.08|||||2-Sided|95.0|-0.33|0.48|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634343|NCT02033889|3002360|Other||Difference in the Least Squares Means|0.27|||||2-Sided|95.0|-0.15|0.68|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634344|NCT02033889|3002361|Other||Difference in the Least Squares Means|0.3|||||2-Sided|95.0|-0.38|0.99|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634345|NCT02033889|3002361|Other||Difference in the Least Squares Means|0.7|||||2-Sided|95.0|0.0|1.39|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634346|NCT02033889|3002362|Other||Difference in the Least Squares Means|-0.23|||||2-Sided|97.0|-0.83|0.37|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634347|NCT02033889|3002362|Other||Difference in the Least Squares Means|-0.1|||||2-Sided|95.0|-0.71|0.5|||||||Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (Metformin monotherapy or Metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634348|NCT02033889|3002381|Superiority||Difference in % vs Placebo|-14.8|||<|0.001|2-Sided|95.0|-20.9|-9.4|||Miettinen & Nurminen method.|Miettinen & Nurminen method was used to construct both the 95% CI and derive p-value for the difference between the proportions (i.e. percentages).|||
1634349|NCT02033889|3002381|Superiority||Difference in % vs Placebo|-16.2|||<|0.001|2-Sided|95.0|-22.2|-11.2|||Miettinen & Nurminen method|Miettinen & Nurminen method was used to construct both the 95% CI and derive p-value for the difference between the proportions (i.e. percentages).|||
1634350|NCT02033889|3002382|Superiority||Adjusted Odds Ratio|3.1||||0.023|2-Sided|95.0|1.17|8.22|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.
1634351|NCT02033889|3002382|Superiority||Adjusted Odds Ratio|5.41|||<|0.001|2-Sided|95.0|2.1|13.9|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.
1634352|NCT02033889|3002383|Superiority||Difference in Least Squares Means|-1.82||||0.013|2-Sided|95.0|-3.24|-0.39|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634353|NCT02033889|3002383|Superiority||Difference in Least Squares Means|-2.42||||0.001|2-Sided|95.0|-3.86|-0.98|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634354|NCT02033889|3002384|Superiority||Difference in Least Squares Means|-3.68||||0.002|2-Sided|95.0|-5.96|-1.39|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634355|NCT02033889|3002384|Superiority||Difference in Least Squares Means|-4.5|||<|0.001|2-Sided|95.0|-6.81|-2.19|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status, and the interaction of time by treatment. Time was treated as a categorical variable.
1634356|NCT02033889|3002385|Superiority||Adjusted Odds Ratio Relative to Placebo|3.03|||<|0.001|2-Sided|95.0|1.81|5.06|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.
1634357|NCT02033889|3002385|Superiority||Adjusted Odds Ratio Relative to Placebo|4.48|||<|0.001|2-Sided|95.0|2.64|7.62|||Regression, Logistic||||Adjusted odds ratio based on a logistic regression model fitted with fixed effects for treatment, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), menopausal status, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using a multiple imputation procedure based on cLDA prediction modeling with fixed effects as in the primary analysis, which allows for participants with missing data to be included in the analysis.
1634398|NCT02033850|3002401|Superiority|||||||0.658|||||||Chi-squared|||Visual search variations (baseline vs 12 months)|
1634399|NCT02033850|3002401|Superiority|||||||0.038|||||||Chi-squared|||Visual search variations (6 vs 12 months)|
1634358|NCT02033889|3002386|Superiority||Difference in Least Squares Means|-1.67|||<|0.001|2-Sided|95.0|-2.24|-1.11|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.
1634359|NCT02033889|3002386|Superiority||Difference in Least Squares Means|-1.6|||<|0.001|2-Sided|95.0|-2.16|-1.03|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.
1634360|NCT02033889|3002387|Superiority||Difference in the Least Squares Means|-26.69|||<|0.001|2-Sided|95.0|-32.9|-20.48|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.
1634361|NCT02033889|3002387|Superiority||Difference in Least Squares Means|-38.25|||<|0.001|2-Sided|95.0|-44.5|-31.99|||Constrained Longitudinal Data Analysis||||Based on the cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.
1634362|NCT02033889|3002388|Other||Difference in % vs Placebo/Glimepiride|1.0|||||2-Sided|95.0|-2.5|4.7|||||||Miettinen & Nurminen method was used to construct the 95% CI
1634363|NCT02033889|3002388|Other||Difference in % vs Placebo/Glimepiride|1.5|||||2-Sided|95.0|-2.1|5.4|||||||Miettinen & Nurminen method was used to construct the 95% CI
1634364|NCT02033889|3002390|Superiority||Difference in Least Squares Means|-0.7|||<|0.001|2-Sided|95.0|-0.87|-0.53|||Constrained Longitudinal Data Analysis||||Based on cLDA model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another anti-hyperglycemic agent, AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.
1634365|NCT02033889|3002390|Superiority||Difference in Least Squares Means|-0.88|||<|0.001|2-Sided|95.0|-1.05|-0.71|||Constrained Longitudinal Data Analysis||||Based on Constrained Longitudinal Data Analysis (cLDA) model with fixed effects for treatment, time, prior anti hyperglycemic medication (Metformin monotherapy or Metformin + another anti-hyperglycemic agent, AHA), baseline eGFR (continuous), menopausal status. Time was treated as a categorical variable.
1634366|NCT02033876|3002391|Superiority|||||||0.006|||||||ANCOVA||||
1634367|NCT02033876|3002392|Superiority|||||||0.8|||||||ANCOVA||||
1634368|NCT02033876|3002393|Superiority|||||||0.4|||||||ANCOVA||||
1634369|NCT02033876|3002394|Superiority|||||||0.51|||||||ANCOVA||||
1634370|NCT02033876|3002395|Superiority|||||||0.37|||||||ANCOVA||||
1634371|NCT02033876|3002397|Superiority|||||||0.65|||||||ANCOVA||||
1634372|NCT02033876|3002398|Superiority|||||||0.43|||||||ANCOVA||||
1634373|NCT02033850|3002399|Superiority|||||||0.039||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in left VIIb lobule|
1634374|NCT02033850|3002399|Superiority|||||||0.04||||||"Corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in right VIIb lobule|
1634375|NCT02033850|3002399|Superiority|||||||0.029||||||"Corrected for multiple comparisons using the “3D” parameter settings with threshold-free cluster enhancement.~A priori threshold for statistical significance 0.05"|General linear model voxel-wise|||Z-transformed ReHo difference in vermis VIIIb|
1634376|NCT02033850|3002400|Superiority|||||||0.478|||||||Chi-squared||||
1634377|NCT02033850|3002401|Superiority|||||||0.169|||||||Chi-squared|||ROCF copy variations (baseline vs 12 months)|
1634378|NCT02033850|3002401|Superiority|||||||0.027|||||||Chi-squared|||ROCF copy variations (6 vs 12 months)|
1634379|NCT02033850|3002401|Superiority|||||||1|||||||Chi-squared|||ROCF copy variations (baseline vs 6 months)|
1634380|NCT02033850|3002401|Superiority|||||||0.951|||||||Chi-squared|||Semantic fluency variation (baseline vs 12 months)|
1634381|NCT02033850|3002401|Superiority|||||||0.674|||||||Chi-squared|||Semantic fluency variations (6 vs 12 months)|
1634382|NCT02033850|3002401|Superiority|||||||0.951|||||||Chi-squared|||Semantic fluency variations (baseline vs 6 months)|
1634383|NCT02033850|3002401|Superiority|||||||0.951|||||||Chi-squared|||Phonemic fluency variation (baseline vs 12 months)|
1634384|NCT02033850|3002401|Superiority|||||||0.961|||||||Chi-squared|||Phonemic fluency variations (6 vs 12 months)|
1634385|NCT02033850|3002401|Superiority|||||||0.413|||||||Chi-squared|||Phonemic fluency variations (baseline vs 6 months)|
1634386|NCT02033850|3002401|Superiority|||||||0.881|||||||Chi-squared|||TMT-B variations (baseline vs 12 months)|
1634387|NCT02033850|3002401|Superiority|||||||0.952|||||||Chi-squared|||TMT-B variations (6 vs 12 months)|
1634388|NCT02033850|3002401|Superiority|||||||0.453|||||||Chi-squared|||TMT-B variations (baseline vs 6 months)|
1634389|NCT02033850|3002401|Superiority|||||||0.295|||||||Chi-squared|||TMT-A variations (baseline vs 12 months)|
1634390|NCT02033850|3002401|Superiority|||||||0.241|||||||Chi-squared|||TMT-A variations (6 vs 12 months)|
1634391|NCT02033850|3002401|Superiority|||||||0.42|||||||Chi-squared|||TMT-A variations (baseline vs 6 months)|
1634392|NCT02033850|3002401|Superiority|||||||0.477|||||||Chi-squared|||Stroop test variations (baseline vs 12 months)|
1634393|NCT02033850|3002401|Superiority|||||||0.413|||||||Chi-squared|||Stroop test variations (6 vs 12 months)|
1634394|NCT02033850|3002401|Superiority|||||||0.961|||||||Chi-squared|||Stroop test variations (baseline vs 6 months)|
1634395|NCT02033850|3002401|Superiority|||||||0.17|||||||Chi-squared|||SDMT variations (baseline vs 12 months)|
1634396|NCT02033850|3002401|Superiority|||||||0.674|||||||Chi-squared|||SDMT variations (6 vs 12 months)|
1634397|NCT02033850|3002401|Superiority|||||||0.522|||||||Chi-squared|||SDMT variations (baseline vs 6 months)|
1634400|NCT02033850|3002401|Superiority|||||||1|||||||Chi-squared|||Visual search variations (baseline vs 6 months)|
1634401|NCT02033850|3002401|Superiority|||||||0.413|||||||Chi-squared|||Short story variations (baseline vs 12 months)|
1634402|NCT02033850|3002401|Superiority|||||||0.578|||||||Chi-squared|||Short story variations (6 vs 12 months)|
1634403|NCT02033850|3002401|Superiority|||||||0.942|||||||Chi-squared|||Short story variations (baseline vs 6 months)|
1634404|NCT02033850|3002401|Superiority|||||||0.498|||||||Chi-squared|||ROCF recall variations (baseline vs 12 months)|
1634405|NCT02033850|3002401|Superiority|||||||0.134|||||||Chi-squared|||ROCF recall variations (6 vs 12 months)|
1634406|NCT02033850|3002401|Superiority|||||||0.777|||||||Chi-squared|||ROCF recall variations (baseline vs 6 months)|
1634407|NCT02033850|3002401|Superiority|||||||0.413|||||||Chi-squared|||RAVL recall variations (baseline vs 12 months)|
1634408|NCT02033850|3002401|Superiority|||||||0.17|||||||Chi-squared|||RAVL recall variations (6 vs 12 months)|
1634409|NCT02033850|3002401|Superiority|||||||0.089|||||||Chi-squared|||RAVL recall variations (baseline vs 6 months)|
1634410|NCT02033850|3002401|Superiority|||||||0.241|||||||Chi-squared|||RAVL immed. variations (baseline vs 12 months)|
1634411|NCT02033850|3002401|Superiority|||||||0.089|||||||Chi-squared|||RAVL immed. variations (6 vs 12 months)|
1634412|NCT02033850|3002401|Superiority|||||||0.068|||||||Chi-squared|||RAVL immed. variations (baseline vs 6 months)|
1634413|NCT02033850|3002401|Superiority|||||||0.3|||||||Chi-squared|||MMSE variations (baseline vs 12 months)|
1634414|NCT02033850|3002401|Superiority|||||||0.973|||||||Chi-squared|||MMSE variations (6 vs 12 months)|
1634415|NCT02033850|3002401|Superiority|||||||0.973|||||||Chi-squared|||MMSE variations (baseline vs 6 months)|
1634416|NCT02033850|3002401|Superiority|||||||0.716|||||||Chi-squared|||MoCA variations (baseline vs 12 months)|
1634417|NCT02033850|3002401|Superiority|||||||0.17|||||||Chi-squared|||MoCA variations (6 vs 12 months)|
1634418|NCT02033850|3002401|Superiority|||||||0.92|||||||Chi-squared|||MoCA variations (baseline vs 6 months)|
1634419|NCT02033850|3002402|Superiority|||||||0.486|||||||t-test, 2 sided|||Δs on semantic fluency (baseline vs 12 months)|
1634420|NCT02033850|3002402|Superiority|||||||0.973|||||||t-test, 2 sided|||Δs on semantic fluency (6 vs 12 months)|
1634421|NCT02033850|3002402|Superiority|||||||0.392|||||||t-test, 2 sided|||Δs on semantic fluency (baseline vs 6 months)|
1634422|NCT02033850|3002402|Superiority|||||||0.951|||||||t-test, 2 sided|||Δs on phonemic fluency (baseline vs 12 months)|
1634423|NCT02033850|3002402|Superiority|||||||0.835|||||||t-test, 2 sided|||Δs on phonemic fluency (6 vs 12 months)|
1634424|NCT02033850|3002402|Superiority|||||||0.882|||||||t-test, 2 sided|||Δs on phonemic fluency (baseline vs 6 months)|
1634425|NCT02033850|3002403|Superiority|||||||0.534|||||||t-test, 2 sided|||Δs on TMT-B (baseline vs 12 months)|
1634426|NCT02033850|3002403|Superiority|||||||0.651|||||||t-test, 2 sided|||Δs on TMT-B (6 vs 12 months)|
1634427|NCT02033850|3002403|Superiority|||||||0.142|||||||t-test, 2 sided|||Δs on TMT-B (baseline vs 6 months)|
1634428|NCT02033850|3002403|Superiority|||||||0.476|||||||t-test, 2 sided|||Δs on TMT-A (baseline vs 12 months)|
1634429|NCT02033850|3002403|Superiority|||||||0.094|||||||t-test, 2 sided|||Δs on TMT-A (6 vs 12 months)|
1634430|NCT02033850|3002403|Superiority|||||||0.157|||||||t-test, 2 sided|||Δs on TMT-A (baseline vs 6 months)|
1634431|NCT02033850|3002403|Superiority|||||||0.294|||||||t-test, 2 sided|||Δs on Stroop test (baseline vs 12 months)|
1634432|NCT02033850|3002403|Superiority|||||||0.428|||||||t-test, 2 sided|||Δs on Stroop test (6 vs 12 months)|
1634433|NCT02033850|3002403|Superiority|||||||0.743|||||||t-test, 2 sided|||Δs on Stroop test (baseline vs 6 months)|
1634434|NCT02033850|3002404|Superiority|||||||0.789|||||||t-test, 2 sided|||Δs on ROCF copy (baseline vs 12 months)|
1634435|NCT02033850|3002404|Superiority|||||||0.235|||||||t-test, 2 sided|||Δs on ROCF copy (6 vs 12 months)|
1634436|NCT02033850|3002404|Superiority|||||||0.098|||||||t-test, 2 sided|||Δs on ROCF copy (baseline vs 6 months)|
1634437|NCT02033850|3002404|Superiority|||||||0.639|||||||t-test, 2 sided|||Δs on SDMT (baseline vs 12 months)|
1634438|NCT02033850|3002404|Superiority|||||||0.198|||||||t-test, 2 sided|||Δs on SDMT (6 vs 12 months)|
1634439|NCT02033850|3002404|Superiority|||||||0.328|||||||t-test, 2 sided|||Δs on SDMT (baseline vs 6 months)|
1634440|NCT02033850|3002404|Superiority|||||||0.674|||||||t-test, 2 sided|||Δs on visual search (baseline vs 12 months)|
1634441|NCT02033850|3002404|Superiority|||||||0.405|||||||t-test, 2 sided|||Δs on visual search (6 vs 12 months)|
1634442|NCT02033850|3002404|Superiority|||||||0.762|||||||t-test, 2 sided|||Δs on visual search (baseline vs 6 months)|
1634443|NCT02033850|3002404|Superiority|||||||0.527|||||||t-test, 2 sided|||Δs on short story (baseline vs 12 months)|
1634444|NCT02033850|3002404|Superiority|||||||0.42|||||||t-test, 2 sided|||Δs on short story (6 vs 12 months)|
1634445|NCT02033850|3002404|Superiority|||||||0.164|||||||t-test, 2 sided|||Δs on short story (baseline vs 6 months)|
1634446|NCT02033850|3002404|Superiority|||||||0.768|||||||t-test, 2 sided|||Δs on ROCF recall (baseline vs 12 months)|
1634447|NCT02033850|3002404|Superiority|||||||0.358|||||||t-test, 2 sided|||Δs on ROCF recall (6 vs 12 months)|
1634448|NCT02033850|3002404|Superiority|||||||0.184|||||||t-test, 2 sided|||Δs on ROCF recall (baseline vs 6 months)|
1634449|NCT02033850|3002404|Superiority|||||||0.268|||||||t-test, 2 sided|||Δs on RAVL recall (baseline vs 12 months)|
1634450|NCT02033850|3002404|Superiority|||||||0.212|||||||t-test, 2 sided|||Δs on RAVL recall (6 vs 12 months)|
1634451|NCT02033850|3002404|Superiority|||||||0.858|||||||t-test, 2 sided|||Δs on RAVL recall (baseline vs 6 months)|
1634452|NCT02033850|3002404|Superiority|||||||0.032|||||||t-test, 2 sided|||Δs on RAVL immediate (baseline vs 12 months)|
1634453|NCT02033850|3002404|Superiority|||||||0.021|||||||t-test, 2 sided|||Δs on RAVL immediate (6 vs 12 months)|
1634454|NCT02033850|3002404|Superiority|||||||0.839|||||||t-test, 2 sided|||Δs on RAVL immediate (baseline vs 6 months)|
1634455|NCT02033850|3002404|Superiority|||||||0.601|||||||t-test, 2 sided|||Δs on MMSE (baseline vs 12 months)|
1634456|NCT02033850|3002404|Superiority|||||||0.236|||||||t-test, 2 sided|||Δs on MMSE (6 vs 12 months)|
1634457|NCT02033850|3002404|Superiority|||||||0.458|||||||t-test, 2 sided|||Δs on MMSE (baseline vs 6 months)|
1634458|NCT02033850|3002404|Superiority|||||||0.381|||||||t-test, 2 sided|||Δs on MoCA (baseline vs 12 months)|
1634459|NCT02033850|3002404|Superiority|||||||0.188|||||||t-test, 2 sided|||Δs on MoCA (6 vs 12 months)|
1634460|NCT02033850|3002404|Superiority|||||||0.936|||||||t-test, 2 sided|||Δs on MoCA (baseline vs 6 months)|
1634461|NCT02033850|3002405|Superiority|||||||0.79|||||||Chi-squared|||PCS outcome (baseline vs 12 months)|
1634462|NCT02033850|3002405|Superiority|||||||0.191|||||||Chi-squared|||PCS outcome (6 vs 12 months)|
1634463|NCT02033850|3002405|Superiority|||||||0.576|||||||Chi-squared|||PCS outcome (baseline vs 6 months)|
1634464|NCT02033850|3002405|Superiority|||||||0.115|||||||Chi-squared|||MCS outcome (baseline vs 12 months)|
1634465|NCT02033850|3002405|Superiority|||||||0.729|||||||Chi-squared|||MCS outcome (6 vs 12 months)|
1634466|NCT02033850|3002405|Superiority|||||||0.095|||||||Chi-squared|||MCS outcome (baseline vs 6 months)|
1634467|NCT02033850|3002406|Superiority|||||||0.867|||||||t-test, 2 sided|||Δs on PCS (baseline vs 12 months)|
1634468|NCT02033850|3002406|Superiority|||||||0.567|||||||t-test, 2 sided|||Δs on PCS (6 vs 12 months)|
1634469|NCT02033850|3002406|Superiority|||||||0.709|||||||t-test, 2 sided|||Δs on PCS (baseline vs 6 months)|
1634470|NCT02033850|3002406|Superiority|||||||0.668|||||||t-test, 2 sided|||Δs on MCS (baseline vs 12 months)|
1634471|NCT02033850|3002406|Superiority|||||||0.274|||||||t-test, 2 sided|||Δs on MCS (6 vs 12 months)|
1634472|NCT02033850|3002406|Superiority|||||||0.567|||||||t-test, 2 sided|||Δs on MCS (baseline vs 6 months)|
1634473|NCT02033850|3002406|Superiority|||||||0.448|||||||t-test, 2 sided|||Δs on GDS (baseline vs 12 months)|
1634474|NCT02033850|3002406|Superiority|||||||0.958|||||||t-test, 2 sided|||Δs on GDS (6 vs 12 months)|
1634475|NCT02033850|3002406|Superiority|||||||0.393|||||||t-test, 2 sided|||Δs on GDS (baseline vs 6 months)|
1634476|NCT02033850|3002406|Superiority|||||||0.056|||||||t-test, 2 sided|||Δs on EQ visual (baseline vs 12 months)|
1634477|NCT02033850|3002406|Superiority|||||||0.685|||||||t-test, 2 sided|||Δs on EQ visual (6 vs 12 months)|
1634478|NCT02033850|3002406|Superiority|||||||0.057|||||||t-test, 2 sided|||Δs on EQ visual (baseline vs 6 months)|
1634479|NCT02033850|3002406|Superiority|||||||0.647|||||||t-test, 2 sided|||Δs on EQ index (baseline vs 12 months)|
1634480|NCT02033850|3002406|Superiority|||||||0.283|||||||t-test, 2 sided|||Δs on EQ index (6 vs 12 months)|
1634481|NCT02033850|3002406|Superiority|||||||0.698|||||||t-test, 2 sided|||Δs on EQ index (baseline vs 6 months)|
1634482|NCT02033850|3002406|Superiority|||||||0.193|||||||t-test, 2 sided|||Δs on AQ (baseline vs 12 months)|
1634483|NCT02033850|3002406|Superiority|||||||0.81|||||||t-test, 2 sided|||Δs on AQ (6 vs 12 months)|
1634484|NCT02033850|3002406|Superiority|||||||0.204|||||||t-test, 2 sided|||Δs on AQ (baseline vs 6 months)|
1634485|NCT02033850|3002407|Superiority|||||||0.8|||||||t-test, 2 sided|||Δs on DAD (baseline vs 12 months)|
1634486|NCT02033850|3002407|Superiority|||||||0.522|||||||t-test, 2 sided|||Δs on DAD (6 vs 12 months)|
1634487|NCT02033850|3002407|Superiority|||||||0.612|||||||t-test, 2 sided|||Δs on DAD (baseline vs 6 months)|
1634488|NCT02033850|3002407|Superiority|||||||0.457|||||||t-test, 2 sided|||Δs on IADL (baseline vs 12 months)|
1634489|NCT02033850|3002407|Superiority|||||||0.134|||||||t-test, 2 sided|||Δs on IADL (6 vs 12 months)|
1634490|NCT02033850|3002407|Superiority|||||||0.24|||||||t-test, 2 sided|||Δs on IADL (baseline vs 6 months)|
1634491|NCT02033850|3002407|Superiority|||||||0.262|||||||t-test, 2 sided|||Δs on ADL (baseline vs 12 months)|
1634492|NCT02033850|3002407|Superiority|||||||0.618|||||||t-test, 2 sided|||Δs on ADL (6 vs 12 months)|
1634493|NCT02033850|3002407|Superiority|||||||0.145|||||||t-test, 2 sided|||Δs on ADL (baseline vs 6 months)|
1634494|NCT02033694|3002413|Other||Cox Proportional Hazard|4.22|||<|0.0001|2-Sided|95.0|2.39|7.45|||Regression, Cox|||Secondary Hypothesis 2 (Vulnerable Plaque)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm > 400 in the coronary artery segment as the independent variable and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome.|
1634495|NCT02033694|3002413|Other||Cox Proportional Hazard|2.18|||<|0.0001|2-Sided|95.0|1.48|3.22|||Regression, Cox|||Secondary Hypothesis 1 (Vulnerable Patient)- Cox proportional hazards regression model to assess a threshold of maxLCBI4mm > 400 as the independent variable and NC-MACE during 2 years as the outcome.|
1634496|NCT02033694|3002414|Other||Cox Proportional Hazard|1.45|||<|0.0001|2-Sided|95.0|1.3|1.6|||Regression, Cox|||Hypothesis 2 (Vulnerable Plaque Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm in the coronary artery segment is the measure of exposure and NC-MACE during 2 years caused by a new culprit lesion in that segment is the outcome. This analysis was performed with adjustment for the potential clustering effect within patient utilizing the Wei, Lin and Weissfeld (WLW) methodology. This analysis determined whether maxLCBI4mm is a risk factor NC-MACE.|
1634497|NCT02033694|3002414|Other||Cox Proportional Hazard|1.21|||<|0.0004|2-Sided|95.0|1.09|1.35|||Regression, Cox|||Hypothesis 1 (Vulnerable Patient Hypothesis) first fit a univariate proportional hazards regression model in which maxLCBI4mm is the only independent variable and NC-MACE during 2 years is the outcome. The null hypothesis tested by the Wald test that the regression coefficient in a proportional hazards regression model is significantly different from 0. This analysis determined whether maxLCBI4mmI is a risk factor for NC-MACE.|
1634498|NCT02033317|3002433|Superiority or Other||||||=|0|||||||paired t-test||||
1634499|NCT02033317|3002434|Superiority or Other||||||=|0|||||||paired t-test||||
1634500|NCT02033213|3002435|Superiority or Other|||||||0.02|||||||t-test, 1 sided||||
1634502|NCT02033213|3002437|Superiority or Other|||||||0.096||||||P < 0.05 was considered significant.|t-test, 1 sided||||
1634503|NCT02033213|3002437|Superiority or Other|||||||0.03||||||P < 0.05 was considered significant.|t-test, 1 sided||||
1634504|NCT02033213|3002438|Superiority or Other|||||||0.574||||||P < 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.|
1634505|NCT02033213|3002438|Superiority or Other|||||||0.322||||||P < 0.05 was considered significant.|t-test, 1 sided|||The measurement aws assessed at 10 minutes time point.|
1634506|NCT02033213|3002439|Superiority or Other|||||||0.41||||||P < 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.|
1634507|NCT02033213|3002439|Superiority or Other|||||||0.791||||||P < 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 10 minutes time point.|
1634508|NCT02033213|3002440|Superiority or Other|||||||0.621||||||P < 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 6 hours time point.|
1634509|NCT02033213|3002440|Superiority or Other|||||||0.41||||||P < 0.05 was considered significant.|t-test, 1 sided|||The measurement was assessed at 10 minutes time point.|
1634510|NCT02033200|3002441|Superiority or Other||LS means difference|0.227|Standard Error of the Mean|0.33||0.4931|2-Sided|95.0|-0.43|0.884|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the left eye.|
1634511|NCT02033200|3002441|Superiority or Other||LS means difference|0.091|Standard Error of the Mean|0.4||0.8209|2-Sided|95.0|-0.705|0.887|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the right eye.|
1634512|NCT02033200|3002442|Superiority or Other||LS means difference|-0.18|Standard Error of the Mean|0.344||0.6013|2-Sided|95.0|-0.865|0.504|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.|
1634513|NCT02033200|3002442|Superiority or Other||LS Means difference|-0.078|Standard Error of the Mean|0.278||0.7787|2-Sided|95.0|-0.632|0.475|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.|
1634514|NCT02033200|3002443|Superiority or Other||LS means difference|0.007|Standard Error of the Mean|0.058||0.9107|2-Sided|95.0|-0.109|0.122|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.|
1634515|NCT02033200|3002443|Superiority or Other||LS means difference|0.016|Standard Error of the Mean|0.055||0.7723|2-Sided|95.0|-0.093|0.125|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.|
1634516|NCT02033200|3002444|Superiority or Other||LS means difference|-0.002|Standard Error of the Mean|0.022||0.9334|2-Sided|95.0|-0.045|0.042|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.|
1634517|NCT02033200|3002444|Superiority or Other||LS Means difference|0.017|Standard Error of the Mean|0.017||0.3139|2-Sided|95.0|-0.017|0.051|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.|
1634518|NCT02033200|3002445|Superiority or Other||LS means difference|0.751|Standard Error of the Mean|0.348||0.0343|2-Sided|95.0|0.057|1.44|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in intraocular pressure between the two treatment groups in the left eye.|
1634519|NCT02033200|3002445|Superiority or Other||LS means difference|-0.031|Standard Error of the Mean|0.359||0.9324|2-Sided|95.0|-0.746|0.685|||ANCOVA|||The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in Intraocular Pressure between the two treatment groups in the right eye.|
1634520|NCT02033200|3002446|Superiority or Other||LS means difference|-0.087|Standard Error of the Mean|0.061||0.1583|2-Sided|95.0|-0.209|0.035|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.|
1634521|NCT02033200|3002446|Superiority or Other||LS means difference|-0.16|Standard Error of the Mean|0.061||0.0101|2-Sided|95.0|-0.28|-0.039|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.|
1634522|NCT02033200|3002447|Superiority or Other||LS Means difference|-0.022|Standard Error of the Mean|0.017||0.1953|2-Sided|95.0|-0.056|0.012|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.|
1634523|NCT02033200|3002447|Superiority or Other||LS means difference|0.004|Standard Error of the Mean|0.014||0.7864|2-Sided|95.0|-0.024|0.031|||ANCOVA|||The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.|
1634524|NCT02033200|3002448|Superiority or Other||LS means difference|0.257|Standard Error of the Mean|0.258||0.324|2-Sided|95.0|-0.258|0.771|||ANCOVA|||The sample size had adequate power to detect a meaningful difference between treatment groups in the left eye.|
1634525|NCT02033200|3002448|Superiority or Other||LS mean difference|0.076|Standard Error of the Mean|0.335||0.8216|2-Sided|95.0|-0.592|0.744|||ANCOVA|||The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.|
1634526|NCT02033174|3002449|Superiority or Other|||||||0.05|||||||Kruskal-Wallis||||
1634527|NCT02032641|3002499|Superiority or Other||||||>|0.1||||||The threshold for significance is p<0.05|t-test, 1 sided||||
1634528|NCT02032641|3002499|Superiority or Other||||||<|0.05||||||The threshold for significance is p<0.05|t-test, 1 sided||||
1634529|NCT02032420|3002514|Superiority or Other|||||||0.003|||||||Fisher Exact||||
1634530|NCT02032420|3002515|Superiority or Other|||||||0.038|||||||Wilcoxon (Mann-Whitney)||||
1634531|NCT02032420|3002516|Superiority or Other|||||||0.004|||||||Repeated-measures MANOVA|The p value is for the effect of group assignment across three iterations of the assigned task.|||
1634532|NCT02032420|3002517|Superiority or Other||||||<|0.001|||||||Repeated-measures MANOVA|The reported p value is for the effect of group assignment across three iterations of the assigned task.|||
1634533|NCT02031640|3002537|Superiority||Mean Difference (Final Values)|-0.216||||0.0003|2-Sided|95.0|-0.332|-0.101|||Mixed Models Analysis||||
1634534|NCT02031640|3002537|Superiority||Mean Difference (Final Values)|-0.189||||0.0016|2-Sided|95.0|-0.306|-0.072|||Mixed Models Analysis||||
1634535|NCT02031640|3002537|Superiority||Mean Difference (Final Values)|-0.102||||0.0854|2-Sided|95.0|-0.217|0.014|||Mixed Models Analysis||||
1634536|NCT02031640|3002537|Superiority||Mean Difference (Final Values)|-0.149||||0.0119|2-Sided|95.0|-0.265|-0.033|||Mixed Models Analysis||||
1634537|NCT02031640|3002538|Superiority||LSM difference|-0.801|||<|0.0001|2-Sided|95.0|-1.138|-0.464|||Mixed Model for repeated measures||||
1634538|NCT02031640|3002538|Superiority||LSM Difference|-0.651|||<|0.0002|2-Sided|95.0|-0.994|-0.309|||Mixed Model for repeated measures||||
1634539|NCT02031640|3002538|Superiority||LSM Difference|-0.691|||<|0.0001|2-Sided|95.0|-1.029|-0.352|||Mixed Model for repeated measures||||
1634540|NCT02031640|3002538|Superiority||LSM Difference|-0.703|||<|0.0001|2-Sided|95.0|-1.044|-0.363|||Mixed Model for repeated measures||||
1634541|NCT02031640|3002539|Superiority||LSM Difference|10.301||||0.0053|2-Sided|95.0|3.073|17.53|||Mixed Model for repeated measures||||
1634542|NCT02031640|3002539|Superiority||LSM Difference|4.088||||0.2704|2-Sided|95.0|-3.191|11.367|||Mixed Model for repeated measures||||
1634543|NCT02031640|3002539|Superiority||LSM Difference|9.17||||0.0133|2-Sided|95.0|1.914|16.425|||Mixed Model for repeated measures||||
1634544|NCT02031640|3002539|Superiority||LSM Difference|9.147||||0.0139|2-Sided|95.0|1.866|16.429|||Mixed Model for repeated measures||||
1634545|NCT02031640|3002540|Superiority||LSM Difference|12.512||||0.0006|2-Sided|95.0|5.435|19.589|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction|
1634546|NCT02031640|3002540|Superiority||LSM Difference|6.004||||0.0984|2-Sided|95.0|-1.121|13.129|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction|
1634547|NCT02031640|3002540|Superiority||LSM Difference|8.419||||0.0204|2-Sided|95.0|1.309|15.53|||Mixed Model for repeated measures|||The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction|
1634548|NCT02031640|3002540|Other|The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF over the 12-week treatment period was performed using a repeated measures mixed model with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time-by-treatment interaction.|LSM Difference|10.616||||0.0036|2-Sided|95.0|3.489|17.744|||Mixed Model for repeated measures||||
1634549|NCT02031640|3002541|Superiority||LSM Difference|0.04||||0.1932|2-Sided|95.0|-0.02|0.1|||ANCOVA||||
1634550|NCT02031640|3002541|Superiority||LSM Difference|-0.015||||0.6356|2-Sided|95.0|-0.075|0.046|||ANCOVA||||
1634551|NCT02031640|3002541|Superiority||LSM Difference|0.045||||0.1415|2-Sided|95.0|-0.015|0.106|||ANCOVA||||
1634552|NCT02031640|3002541|Superiority||Least Square Mean (LSM) Difference|0.034||||0.272|2-Sided|95.0|-0.027|0.095|||ANCOVA||||
1634553|NCT02031302|3002621|Other|One-sided Clopper-Pearson 98.699% upper bound|||||<|0.0001||||||The proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure.|Chi-squared|||Note: the 95% CI is from Clopper-Pearson Exact Method. The analysis was only done for the Lotus valve arm as the Lotus with Depth Guard arm has not sufficient power for this statistical analysis.|One-sided Clopper-Pearson 98.699% upper bound: 4.11% Performance goal is 14%
1634554|NCT02031276|3002622|Other||difference in percentage of participants|7.4||||0.0107|2-Sided|95.0|1.7|13.0|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.|
1634555|NCT02031276|3002623|Other||difference in percentage of participants|2.4||||0.4977|2-Sided|95.0|-4.5|9.2|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.|
1634556|NCT02031276|3002624|Other||difference in percentage of participants|18.7||||0.0104|2-Sided|95.0|4.4|33.0|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.|
1634557|NCT02031276|3002625|Other||difference in percentage of participants|12.0||||0.0057|2-Sided|95.0|3.5|20.6|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.|
1634558|NCT02031276|3002626|Other||difference in percentage of participants|13.4||||0.1151|2-Sided|95.0|-3.3|30.1|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-TNF exposure.|
1634559|NCT02031276|3002627|Other||difference in percentage of participants|12.6||||0.0955|2-Sided|95.0|-2.2|27.5|||Cochran-Mantel-Haenszel|||Statistics for the difference are calculated using the Cochran-Mantel-Haenszel risk difference stratified by anti-tumor necrosis factor (anti-TNF) exposure.|
1634560|NCT02030821|3002634|Other||||||<|0.05|||||||Kruskal-Wallis||||
1634561|NCT02030821|3002635|Other||||||<|0.05|||||||Kruskal-Wallis||||
1634562|NCT02030821|3002636|Other||||||<|0.05|||||||Chi-squared||||
1634563|NCT02030821|3002637|Other||||||<|0.05|||||||Kruskal-Wallis||||
1634564|NCT02030600|3002639|Non-Inferiority or Equivalence|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%|Treatment contrast|0.06|||||2-Sided|95.0|-0.07|0.18||||||Change from baseline in HbA1c at week 64 (treatment period 2). The baseline values are week 32 values. Before the primary endpoint was tested, the secondary supportive efficacy endpoint “Change from baseline in HbA1c after 32 weeks of treatment” was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was performed using a MMRM with treatment, sex, antidiabetic therapy at screening, visit and dosing time as fixed effects, and age and baseline HbA1c as covariates.|
1634565|NCT02030600|3002639|Non-Inferiority or Equivalence|Non-inferiority of IDeg against IGlar was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.40%.|Treatment contrast|0.09|||||2-Sided|95.0|-0.04|0.23||||||Change from baseline in HbA1c at week 32 (treatment period 1). Before the primary endpoint was tested, the secondary supportive efficacy endpoint “Change from baseline in HbA1c after 32 weeks of treatment” was tested for non-inferiority as prerequisite for testing the primary endpoint. Analysis was performed using a mixed model for repeated measurement (MMRM) with treatment, sex, antidiabetic therapy at screening, visit and dosing time as fixed effects, and age and baseline HbA1c as covariates.|
1634566|NCT02030600|3002641|Superiority or Other|||||||0.3458||||||Superiority was confirmed if the p-value was less than 0.025.|McNemar|||"Stepwise hierarchical testing procedure:~Step 3: Proportion of subjects with one or more severe hypoglycaemic episodes in the maintenance period."|
1634567|NCT02030600|3002642|Superiority or Other||Treatment ratio|0.58|||<|0.0001|2-Sided|95.0|0.46|0.74|||Poisson||Superiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was entirely below 1.0.|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Number of treatment-emergent severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes during the maintenance period."|
1634568|NCT02030600|3002643|Superiority or Other||Treatment ratio|0.7|||<|0.0001|2-Sided|95.0|0.61|0.8|||Poisson||Superiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was entirely below 1.0.|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period"|
1634569|NCT02030535|3002662|Superiority or Other||Adjusted mean difference|-0.033|Standard Error of the Mean|0.016|||2-Sided|95.0|-0.065|-0.001|||||Tio+Olo 5/5μg minus Tiotropium 5μg + Olodaterol 5μg.|Descriptive comparison. Statistical Analyses 1 & 2 were included in the hierarchical testing sequence (alpha protected), and analysis 3 was not included in the hierarchical testing sequence (not alpha protected)|
1634570|NCT02030535|3002662|Superiority or Other||Adjusted mean difference|0.252|Standard Error of the Mean|0.016|<|0.0001|2-Sided|95.0|0.22|0.284||Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect|Mixed models repeated measures analysis|Kenward−Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within−patient variation.|Tiotropium 5μg + Olodaterol 5μg minus Placebo.||
1634571|NCT02030535|3002662|Superiority or Other||Adjusted mean difference|0.219|Standard Error of the Mean|0.016|<|0.0001|2-Sided|95.0|0.187|0.252||Mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; patient baseline and period baseline as covariates; patient as a random effect|Mixed models repeated measures analysis|Kenward−Roger approximation of denominator degrees of freedom. Compound symmetry covariance structure for within−patient variation|Tio+Olo 5/5μg minus Placebo.||
1634572|NCT02029872|3002681|Other|The study was powered for enrollment of 100 subjects with MRSA colonization at baseline. Despite substantial screening, we were unable to enroll enough subjects to meet the necessary sample size.||||||||||||||||Due to low enrollment in the intervention, statistical analysis was not possible.|The study was powered for enrollment of 100 subjects with MRSA colonization at baseline. Despite substantial screening, we were unable to enroll enough subjects to meet the necessary sample size.
1634573|NCT02029274|3002766|Superiority or Other||Mean Difference (Net)|-13.709|Standard Error of the Mean|11.6016||0.2409|2-Sided|95.0|-36.806|9.388|||Repeated measures||||
1634574|NCT02029274|3002766|Superiority or Other||Mean Difference (Net)|-15.368|Standard Error of the Mean|10.9297||0.1637|2-Sided|95.0|-37.128|6.391|||Repeated measures analysis||||
1634575|NCT02029274|3002766|Superiority or Other||Mean Difference (Net)|0.551|Standard Error of the Mean|11.5519||0.9621|2-Sided|95.0|-22.447|23.549|||Repeated measures analysis||||
1634576|NCT02029235|3002767|Other|||||||0.06|||||||t-test, 2 sided|||Null hypothesis: No difference between groups|
1634577|NCT02029235|3002768|Other|||||||0.24|||||||t-test, 2 sided|||"Null hypothesis: No difference between groups~Power analysis: A sample size of 16 in each group had an 80% power to detect a difference in means of 10 mm."|
1634578|NCT02028767|3002783|Non-Inferiority or Equivalence|Bioequivalence test|Geometric mean ratio|98.35|Standard Error of the Mean|1.023|<|0.0001|2-Sided|90.0|94.603|102.252|||ANOVA|The p-value relates to the null hypothesis of non-equivalence.|"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms|
1634579|NCT02028767|3002783|Non-Inferiority or Equivalence|Bioequivalence test|Geometric mean ratio|98.28|Standard Error of the Mean|1.023|<|0|2-Sided|90.0|94.549|102.156||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"||
1634580|NCT02028767|3002784|Non-Inferiority or Equivalence|Bioequivalence test|Geometric mean ratio|98.96|Standard Error of the Mean|1.019|<|0.0001|2-Sided|90.0|95.877|102.15||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms|
1634581|NCT02028767|3002784|Non-Inferiority or Equivalence|Bioequivalence test|Geometric mean ratio|98.93|Standard Error of the Mean|1.019|<|0|2-Sided|90.0|95.856|102.107||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"||
1634582|NCT02028767|3002785|Non-Inferiority or Equivalence|Bioequivalence test|Geometric mean ratio|98.71|Standard Error of the Mean|1.024|<|0.0001|2-Sided|90.0|94.783|102.796||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log-scale: sequence, subjects within sequences, period and treatment as fixed effects"|Analysis with fixed effects for all terms|
1634583|NCT02028767|3002785|Non-Inferiority or Equivalence|Bioequivalence test|Geometric mean ratio|98.57|Standard Error of the Mean|1.024|<|0|2-Sided|90.0|94.662|102.639||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||"The geometric mean ratio is the exponential of the estimated mean difference on the log-scale between 'FDC' and 'Separate tablets'.~ANOVA on the log scale: sequence, period and treatment as fixed effects; subjects within sequences as random effect"||
1634584|NCT02028715|3002793|Superiority||Mean Difference (Final Values)|0.054|Standard Error of the Mean|0.32|||2-Sided|95.0|-0.587|0.695|||||||
1634585|NCT02028715|3002794|Superiority|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.647|||||||ANOVA||||
1634586|NCT02028715|3002795|Superiority|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.217|||||||ANOVA||||
1634587|NCT02028715|3002796|Superiority|Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.||||||0.643|||||||ANOVA||||
1634588|NCT02028715|3002797|Superiority|||||||0.029|||||||ANOVA||||
1634589|NCT02028715|3002798|Superiority||Median Difference (Final Values)|11.51818|Standard Error of the Mean|6.98569||0.105|2-Sided|95.0|-2.49963|25.53599|||t-test for Equality of Means||||
1634590|NCT02028715|3002799|Superiority||Mean Difference (Final Values)|5.55501|Standard Error of the Mean|5.96535||0.356|2-Sided|95.0|-6.3904|17.50042|||t-test for Equality of Means||||
1634591|NCT02028676|3002800|Superiority or Other|||||||0.21||||||Adjusted for randomization stratification factors|Generalised estimating equation|Generalised estimating equation with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634592|NCT02028676|3002801|Superiority or Other||Hazard Ratio (HR)|1.6||||0.04|2-Sided|95.0|1.02|2.5|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue||
1634593|NCT02028676|3002802|Superiority or Other||Mean Difference (Net)|-11.0||||0.68|2-Sided|95.0|-65.0|42.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is stop minus continue||
1634594|NCT02028676|3002803|Superiority or Other||Mean Difference (Net)|-0.6||||0.13|2-Sided|95.0|-1.4|0.2|||Regression, Linear|Adjusted for randomization stratification factors|Difference is stop minus continue||
1634595|NCT02028676|3002804|Superiority or Other|||||||0.34|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634596|NCT02028676|3002805|Superiority or Other|||||||0.19|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634597|NCT02028676|3002806|Superiority or Other|||||||0.07|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634598|NCT02028676|3002807|Superiority or Other||Hazard Ratio (HR)|0.69||||0.68|2-Sided|95.0|0.12|4.15|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue||
1634599|NCT02028676|3002808|Superiority or Other||Hazard Ratio (HR)|1.8||||0.34|2-Sided|95.0|0.53|6.17|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue||
1634600|NCT02028676|3002809|Superiority or Other||Hazard Ratio (HR)|3.98||||0.18|2-Sided|95.0|0.44|35.7|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue||
1634601|NCT02028676|3002810|Superiority or Other||Hazard Ratio (HR)|2.4||||0.03|2-Sided|95.0|1.05|5.48|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue||
1634602|NCT02028676|3002811|Superiority or Other||Hazard Ratio (HR)|1.47||||0.44|2-Sided|95.0|0.56|3.85|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue||
1634603|NCT02028676|3002812|Superiority or Other||Hazard Ratio (HR)|2.21|||<|0.001|2-Sided|95.0|1.5|3.25|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is stop vs continue||
1634604|NCT02028676|3002813|Superiority or Other|||||||0.93|||||||Generalized estimating equations|Generalised estimating equation with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634605|NCT02028676|3002814|Superiority or Other|||||||0.9|||||||Chi-squared||||
1634606|NCT02028676|3002815|Superiority or Other|||||||0.74|||||||Chi-squared||||
1634607|NCT02028676|3002816|Superiority or Other||Hazard Ratio (HR)|0.78||||0.31|2-Sided|95.0|0.48|1.27|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is once-daily vs twice-daily||
1634608|NCT02028676|3002817|Superiority or Other||Hazard Ratio (HR)|1.04||||0.82|2-Sided|95.0|0.72|1.52|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is once-daily vs twice-daily||
1634609|NCT02028676|3002818|Superiority or Other|||||||0.08|||||||Generalised estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634610|NCT02028676|3002819|Superiority or Other|||||||0.54|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634611|NCT02028676|3002820|Superiority or Other|||||||0.16|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634612|NCT02028676|3002821|Superiority or Other||Hazard Ratio (HR)|0.75||||0.51|2-Sided|95.0|0.31|1.77|||Log Rank||Hazard ratio is once-daily vs twice-daily||
1634613|NCT02028676|3002822|Superiority or Other||Hazard Ratio (HR)|0.43||||0.2|2-Sided|95.0|0.11|1.64|||Log Rank||Hazard ratio is once-daily vs twice-daily||
1634614|NCT02028676|3002824|Superiority or Other||Mean Difference (Net)|-87.0||||0.2|2-Sided|95.0|-220.0|46.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily||
1634615|NCT02028676|3002825|Superiority or Other||Mean Difference (Net)|-33.0||||0.36|2-Sided|95.0|-104.0|38.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily||
1634616|NCT02028676|3002826|Superiority or Other||Mean Difference (Net)|8.0||||0.82|2-Sided|95.0|-60.0|76.0|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily||
1634617|NCT02028676|3002827|Superiority or Other||Mean Difference (Net)|-0.8||||0.12|2-Sided|95.0|-1.9|0.2|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily||
1634618|NCT02028676|3002828|Superiority or Other||Mean Difference (Net)|0.0||||0.98|2-Sided|95.0|-0.9|0.9|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily||
1634619|NCT02028676|3002829|Superiority or Other||Mean Difference (Net)|-0.4||||0.39|2-Sided|95.0|-1.2|0.5|||Regression, Linear|Adjusted for randomization stratification factors|Difference is once-daily minus twice-daily||
1634620|NCT02028676|3002830|Superiority or Other||Risk Difference (RD)|-2.3||||0.52|2-Sided|95.0|-9.3|4.7|||Chi-squared||||
1634621|NCT02028676|3002831|Superiority or Other|||||||0.46|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634622|NCT02028676|3002831|Superiority or Other|||||||0.53|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634623|NCT02028676|3002832|Superiority or Other||Hazard Ratio (HR)|3.09||||0.006|2-Sided|95.0|1.39|6.85|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A||
1634624|NCT02028676|3002832|Superiority or Other||Hazard Ratio (HR)|3.8||||0.001|2-Sided|95.0|1.74|8.29|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A||
1634625|NCT02028676|3002832|Superiority or Other|||||||0.002|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors|||
1634626|NCT02028676|3002832|Superiority or Other||Hazard Ratio (HR)|0.95||||0.84|2-Sided|95.0|0.58|1.56|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM||
1634627|NCT02028676|3002833|Superiority or Other||Hazard Ratio (HR)|1.09||||0.56|2-Sided|95.0|0.81|1.46|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A||
1634628|NCT02028676|3002833|Superiority or Other||Hazard Ratio (HR)|0.92||||0.6|2-Sided|95.0|0.68|1.25|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A||
1634629|NCT02028676|3002833|Superiority or Other|||||||0.53|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors|||
1634630|NCT02028676|3002833|Superiority or Other||Hazard Ratio (HR)|1.3||||0.04|2-Sided|95.0|1.02|1.66|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM||
1634631|NCT02028676|3002834|Superiority or Other||Hazard Ratio (HR)|2.0||||0.034|2-Sided|95.0|1.05|3.8|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A||
1634632|NCT02028676|3002834|Superiority or Other||Hazard Ratio (HR)|2.16||||0.017|2-Sided|95.0|1.15|4.08|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A||
1634633|NCT02028676|3002834|Superiority or Other|||||||0.04|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors|||
1634634|NCT02028676|3002834|Superiority or Other||Hazard Ratio (HR)|0.672||||0.09|2-Sided|95.0|0.42|1.075|||Log Rank||Hazard ratio is CDM vs LCM||
1634635|NCT02028676|3002835|Superiority or Other||Hazard Ratio (HR)|0.78||||0.22|2-Sided|95.0|0.48|1.29|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM||
1634636|NCT02028676|3002836|Superiority or Other|||||||0.002|||||||Chi-squared||||
1634637|NCT02028676|3002836|Superiority or Other|||||||0.2|||||||Chi-squared||||
1634638|NCT02028676|3002837|Superiority or Other|||||||0.02|||||||Chi-squared||||
1634639|NCT02028676|3002837|Superiority or Other|||||||0.86|||||||Chi-squared||||
1634640|NCT02028676|3002838|Superiority or Other|||||||0.03|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors|||
1634641|NCT02028676|3002838|Superiority or Other|||||||0.81|||||||Regression, Linear|Adjusted for randomization stratification factors|||
1634642|NCT02028676|3002839|Superiority or Other|||||||0.01|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors|||
1634643|NCT02028676|3002839|Superiority or Other|||||||0.59|||||||Regression, Linear|Adjusted for randomization stratification factors|||
1634644|NCT02028676|3002840|Superiority or Other|||||||0.7|||||||Regression, Linear|Adjusted for randomization stratification factors|||
1634645|NCT02028676|3002841|Superiority or Other|||||||0.45|||||||Regression, Linear|Adjusted for randomization stratification factors|||
1634646|NCT02028676|3002842|Superiority or Other|||||||0.3|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634647|NCT02028676|3002842|Superiority or Other|||||||0.64|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634648|NCT02028676|3002843|Superiority or Other|||||||0.9|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634649|NCT02028676|3002843|Superiority or Other|||||||0.07|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634650|NCT02028676|3002844|Superiority or Other|||||||0.58|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634651|NCT02028676|3002844|Superiority or Other|||||||0.71|||||||Generalized estimating equations|Generalised estimating equations with independent correlation structure and robust standard errors, calculated over all post-randomization visit weeks|||
1634819|NCT02023697|3003224|Other||Hazard Ratio (HR)|1.068||||0.7461|2-Sided|80.0|0.823|1.385|||Log Rank||Arm B/Arm (A+C)||
1634652|NCT02028676|3002845|Superiority or Other||Hazard Ratio (HR)|0.81||||0.25|2-Sided|95.0|0.56|1.16|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A||
1634653|NCT02028676|3002845|Superiority or Other||Hazard Ratio (HR)|0.78||||0.19|2-Sided|95.0|0.54|1.13|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A||
1634654|NCT02028676|3002845|Superiority or Other|||||||0.34||||||Global test with 2df, adjusted for randomization stratification factors|Log Rank||||
1634655|NCT02028676|3002845|Superiority or Other||Hazard Ratio (HR)|1.1||||0.52|2-Sided|95.0|0.82|1.49|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM.||
1634656|NCT02028676|3002846|Superiority or Other||Hazard Ratio (HR)|0.8||||0.24|2-Sided|95.0|0.54|1.17|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A||
1634657|NCT02028676|3002846|Superiority or Other||Hazard Ratio (HR)|0.82||||0.3|2-Sided|95.0|0.55|1.2|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A||
1634658|NCT02028676|3002846|Superiority or Other|||||||0.44|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors|||
1634659|NCT02028676|3002846|Superiority or Other||Hazard Ratio (HR)|1.0||||0.98|2-Sided|95.0|0.73|1.38|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM||
1634660|NCT02028676|3002847|Superiority or Other||Hazard Ratio (HR)|0.91||||0.71|2-Sided|95.0|0.54|1.52|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A||
1634661|NCT02028676|3002847|Superiority or Other||Hazard Ratio (HR)|0.89||||0.64|2-Sided|95.0|0.53|1.48|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A||
1634662|NCT02028676|3002847|Superiority or Other|||||||0.89|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors|||
1634663|NCT02028676|3002848|Superiority or Other||Hazard Ratio (HR)|0.97||||0.93|2-Sided|95.0|0.52|1.81|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm C vs A||
1634664|NCT02028676|3002848|Superiority or Other||Hazard Ratio (HR)|0.66||||0.23|2-Sided|95.0|0.33|1.31|||Regression, Cox|Adjusted for randomization stratification factors|Hazard ratio is Arm B vs A||
1634665|NCT02028676|3002848|Superiority or Other|||||||0.43|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors|||
1634666|NCT02028676|3002848|Superiority or Other||Hazard Ratio (HR)|0.84||||0.45|2-Sided|95.0|0.49|1.44|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM||
1634667|NCT02028676|3002849|Superiority or Other||Hazard Ratio (HR)|1.2||||0.33|2-Sided|95.0|0.83|1.72|||Log Rank||Hazard ratio is stop vs continue.||
1634668|NCT02028676|3002850|Non-Inferiority or Equivalence|With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).|Risk Difference (RD)|4.0||||0.006|2-Sided|95.0|0.8|7.2|||Poisson regression for risk difference||Risk difference is stop vs continue.|"Assumptions~5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year~recruitment starts 1 July 2009 with 10% children (those already on ART for >96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.~cumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough."|
1634669|NCT02028676|3002850|Non-Inferiority or Equivalence|With assumptions above, at least 80% power and one-sided alpha=0.05, 947 children would be required in the stop/continue cotrimoxazole prophylaxis comparison to exclude an increase in hospitalisation/death rate of 3% from 5% to 8% per year in the stop cotrimoxazole arm (upper 95% confidence limit of stop:continue hazard ratio 1.6).|Hazard Ratio (HR)|1.64||||0.007|2-Sided|95.0|1.14|2.37|||Log Rank||Hazard ratio is stop vs continue.|"Assumptions~5% of children receiving daily cotrimoxazole prophylaxis have a new hospitalisation or death per year~recruitment starts 1 July 2009 with 10% children (those already on ART for >96 weeks) entering immediately, and then the remaining children recruited over the following 15 months as they reach 96 weeks on ART. Follow-up is until March 2012.~cumulative loss to follow-up at March 2012 is 10%. See below for further details as box is not big enough"|
1634670|NCT02028676|3002852|Non-Inferiority or Equivalence|631 children would be required to exclude a 12% lower suppression rate in the once daily group with at least 90% power and two-sided alpha=0.05 (lower 95% confidence limit of difference between once and twice daily -12%, the non-inferiority margin). 630 children retains at least 80% (rather than 90%) power to exclude a 10% (rather than 12%) lower suppression rate in the once daily group with one-sided alpha=0.05 (lower 90% confidence limit of difference between once and twice daily -10%).|Risk Difference (RD)|-1.6||||0.65|2-Sided|95.0|-8.4|5.2|||Chi-squared||Difference in suppression <80 copies/ml in once-daily minus twice-daily||
1634671|NCT02028676|3002853|Superiority or Other||Hazard Ratio (HR)|1.58|||<|0.001|2-Sided|95.0|1.29|1.94|||Regression, Cox||||
1634672|NCT02028676|3002853|Superiority or Other||Hazard Ratio (HR)|1.32|||<|0.01|2-Sided|95.0|1.07|1.63|||Regression, Cox||HR is Arm B vs A||
1634673|NCT02028676|3002853|Superiority or Other||||||<|0.0001|||||||Log Rank|Global test with 2df, adjusted for randomization stratification factors|||
1634674|NCT02028676|3002854|Superiority or Other|||||||0.69|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors|||
1634675|NCT02028676|3002855|Superiority or Other|||||||0.33|||||||Regression, Linear|Global test with 2df, adjusted for randomization stratification factors||Assuming a standard deviation for the change in CD4 percentage from baseline to 72 weeks of 10% (slightly higher than that observed in the PENTA 5 trial) 1200 children would provide at least 80% power to detect a difference in change in CD4% from baseline of more than 2.5% across the 3 groups (F-test with 2-sided alpha=0.05) assuming 20% missing data (loss to follow-up during the first year plus failure to attend the week 72 visit/missing sample).|
1634676|NCT02028676|3002856|Superiority or Other||Hazard Ratio (HR)|0.98||||0.83|2-Sided|95.0|0.83|1.16|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM||
1634820|NCT02023697|3003228|Other||Hazard Ratio (HR)|0.999||||0.9958|2-Sided|80.0|0.744|1.341|||Log Rank||Arm C/Arm A||
1634677|NCT02028676|3002857|Non-Inferiority or Equivalence|With assumptions detailed above, >90% power and one-sided alpha=0.05, 1160 children would be required to exclude an increase in progression rate of 1.6% from 2.5% to 4.1% per year in the CDM arm (upper 95% confidence limit of LCM: CDM hazard ratio 1.64).|Risk Difference (RD)|0.32||||0.43|2-Sided|95.0|-0.47|1.12|||Comparison of poisson rates|Statistical analysis plan specified that p-value was to be calculated from the log-rank test, so not provided for the risk difference|Difference is CDM minus LCM|"Assumptions:~control group (LCM) event rate 3% per year~rates are reduced to 2% per year in the best of the induction-maintenance arms leading to an overall rate of progression to new WHO stage 4 or death of 2.5%~recruitment is over 1.5 years and follow-up for a minimum further 3.5 years.~cumulative loss to follow-up is 10% at 5 years. See below for rest of sample size as this box is not big enough."|
1634678|NCT02028676|3002857|Non-Inferiority or Equivalence|Upper 95% confidence interval for the hazard ratio was 1.64, see other analysis for this endpoint for details|Hazard Ratio (HR)|1.13||||0.59|2-Sided|95.0|0.73|1.73|||Log Rank|Adjusted for randomization stratification factors|Hazard ratio is CDM vs LCM||
1634679|NCT02028169|3002860|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634680|NCT02028169|3002860|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6|
1634681|NCT02028169|3002860|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3|
1634682|NCT02028169|3002861|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634683|NCT02028169|3002861|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6|
1634684|NCT02028169|3002861|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3|
1634685|NCT02028169|3002862|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634686|NCT02028169|3002862|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6|
1634687|NCT02028169|3002862|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3|
1634688|NCT02028169|3002863|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634689|NCT02028169|3002863|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6|
1634690|NCT02028169|3002863|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3|
1634691|NCT02028169|3002864|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634692|NCT02028169|3002864|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6|
1634693|NCT02028169|3002864|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3|
1634694|NCT02028169|3002866|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634695|NCT02028169|3002868|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634696|NCT02028169|3002868|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6|
1634697|NCT02028169|3002868|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3|
1634698|NCT02028169|3002869|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634699|NCT02028169|3002870|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634700|NCT02028169|3002870|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6|
1634701|NCT02028169|3002870|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3|
1634702|NCT02028169|3002871|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634703|NCT02028169|3002871|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6|
1634704|NCT02028169|3002871|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3|
1634705|NCT02028169|3002874|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634706|NCT02028169|3002874|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 6|
1634707|NCT02028169|3002874|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 3|
1634708|NCT02028169|3002875|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634709|NCT02028169|3002876|Superiority||||||<|0.001|||||||Friedman test|||Baseline Vs. Month 9|
1634710|NCT02028169|3002877|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634711|NCT02028169|3002878|Superiority||||||<|0.001|||||||Friedman test|||Baseline vs. Month 9|
1634712|NCT02028065|3002879|Superiority or Other||Difference in incidence|0.7|||||2-Sided|95.0|-4.2|3.7|||||Difference is Sugammadex 16 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).||
1634713|NCT02028065|3002879|Superiority or Other||Difference in incidence|0.0|||||2-Sided|95.0|-4.8|2.5|||||Difference is Sugammadex 4 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).||
1634714|NCT02028065|3002880|Superiority or Other||Difference in incidence|8.1|||||2-Sided|95.0|1.7|14.2|||||Difference is Sugammadex 16 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen(Statistics in Medicine 1985;4:213-226).|Planned sample size of 150 participants in each sugammadex group (4 mg/kg and 16 mg/kg) allowed estimation of adjudicated hypersensitivity in each sugammadex group with a 95% confidence interval with a half-width between 1.2 and 4.2 percentage points. Calculation, based on method of Clopper and Pearson (Biometrika 1934;26[4]:404-413), used underlying event rate of up to 6% in the sugammadex high dose group, based on study results from protocol P06042 (NCT00988065).|
1634715|NCT02028065|3002880|Superiority or Other||Difference in incidence|5.3|||||2-Sided|95.0|-0.9|10.7|||||Difference is Sugammadex 4 mg/kg incidence minus Placebo incidence. Confidence interval calculated using method of Miettinen and Nurminen (Statistics in Medicine 1985;4:213-226).|Planned sample size of 150 participants in each sugammadex group (4 mg/kg and 16 mg/kg) allowed estimation of adjudicated hypersensitivity in each sugammadex group with a 95% confidence interval with a half-width between 1.2 and 4.2 percentage points. Calculation, based on method of Clopper and Pearson (Biometrika 1934;26[4]:404-413), used underlying event rate of up to 6% in the sugammadex high dose group, based on study results from protocol P06042 (NCT00988065).|
1634821|NCT02023697|3003230|Other||Hazard Ratio (HR)|1.075||||0.6205|2-Sided|80.0|0.892|1.297|||Log Rank||Arm B/Arm (A+C)||
1634716|NCT02027558|3002946|Superiority||Mean Difference (Final Values)|-17.42|Standard Error of the Mean|4.99||0.0007|2-Sided|95.0|-27.29|-7.55|||t-test, 2 sided||||
1634717|NCT02027558|3002947|Superiority||Mean Difference (Net)|4.35|Standard Error of the Mean|1.26||0.001|2-Sided|95.0|1.87|6.83|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.||
1634718|NCT02027558|3002948|Superiority||Mean Difference (Net)|10.49|Standard Error of the Mean|3.04||0.001|2-Sided|95.0|4.53|16.44|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.||
1634719|NCT02027558|3002949|Superiority||Mean Difference (Net)|-20.46|Standard Error of the Mean|8.75||0.019|2-Sided|95.0|-37.63|-3.29|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.||
1634720|NCT02027558|3002950|Superiority||Mean Difference (Net)|-16.23|Standard Error of the Mean|6.52||0.013|2-Sided|95.0|-29.02|-2.49|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.||
1634721|NCT02027558|3002951|Superiority||Mean Difference (Net)|-3.21|Standard Error of the Mean|0.7|<|0.001|2-Sided|95.0|-4.58|-1.83|||Mixed Models Analysis||The parameter estimate is the improvement in the outcome from baseline to 3-months for the treatment group versus the same improvement in respect to the control group.||
1634722|NCT02027545|3002953|Superiority|||||||0.0458|||||||Regression, Logistic||||
1634723|NCT02027545|3002954|Superiority|||||||0.545|||||||Regression, Logistic||||
1634724|NCT02027428|3002957|Superiority||Hazard Ratio (HR)|0.93|||||2-Sided|95.0|0.59|1.47|||||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|Hazard ratio was based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at the end of Induction, and tumor response (CR/PR or SD) at the end of Induction.|
1634725|NCT02027428|3002959|Superiority||disease control rate ratio|0.99|||||2-Sided|95.0|0.978|1.007|||||Disease control rate ratio: nab-paclitaxel + BSC / BSC Alone|The rate ratio and its 95% confidence interval are based on non-stratified analysis.|
1634726|NCT02027428|3002960|Superiority||Overall response rate ratio|3.15||||0.0978|2-Sided|95.0|0.733|13.574||5% level of significance.|Cochran-Mantel-Haenszel||Response rate ratio: nab-paclitaxel + BSC / BSC Alone||
1634727|NCT02027428|3002961|Superiority||Hazard Ratio (HR)|0.68||||0.0719|2-Sided|95.0|0.44|1.04||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.|
1634728|NCT02027428|3002962|Superiority||Hazard Ratio (HR)|0.88||||0.4711|2-Sided|95.0|0.62|1.25||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.|
1634729|NCT02027428|3002963|Superiority||Overall response rate ratio|1.2||||0.087|2-Sided|95.0|0.948|1.519||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at the end of Induction, and tumor response (CR/PR or SD) at the end of Induction.|Cochran-Mantel-Haenszel||response ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. The rate ratio and its 95% CI were based on the non-stratified analysis.|
1634730|NCT02027428|3002964|Superiority||Hazard Ratio (HR)|0.68||||0.073|2-Sided|95.0|0.44|1.04||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.|
1634731|NCT02027428|3002965|Superiority||Hazard Ratio (HR)|0.84||||0.3323|2-Sided|95.0|0.59|1.19||Stratification factors evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at end of Induction.|stratified log-rank test||Hazard ratio: nab-paclitaxel + BSC / BSC Alone|5% level of significance. Hazard ratio is based on stratified Cox proportional hazards regression model. The following stratification factors were evaluated in the sparse strata elimination algorithm: stage of disease (IIIB or IV) at diagnosis, ECOG performance status (0 or 1) at end of Induction, and tumor response (CR/PR or SD) at the end of Induction.|
1634732|NCT02027311|3002979|Superiority or Other||Odds Ratio (OR)|11.09||||0.002|2-Sided|95.0|2.41|50.94||Logistic regression model were used in univariate and corrected multivariate analyses to identify the factors related to the primary outcome variables, such as, presence of intervention (frequency of intervention = 0, vs. ≥ 1).|Regression, Logistic|||All the continuous variables were compared using the Mann-Whitney U test and dichotomous categorical variables was used and the Pearson chi-square with Fisher exact test. We used the linear mixed model to compare the differences of paired data, such as mean values of RR, SpO2, MAP, HR, and RSS at different time points of the two different sedation groups. For two-sided tests, p < 0.05 was considered statistically significant.|
1634822|NCT02023697|3003234|Other||Hazard Ratio (HR)|1.26||||0.3134|2-Sided|80.0|0.939|1.69|||Log Rank||Arm C /Arm A||
1634733|NCT02027311|3002980|Superiority or Other|||||||0.05||||||For two-sided tests, p < 0.05 was considered statistically significant.|Regression, Logistic|Logistic regression model used to identify the factors related to the presence of intervention (frequency of intervention = 0, vs. ≥ 1).||If the true difference in the experimental and control means is 4, total 26 experimental subjects and 26 control subjects was required to reject the null hypothesis that the means of the primary outcome values of experimental and control groups are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05.|
1634734|NCT02027025|3002982|Superiority|||||||0.8829|||||||Chi-squared||||
1634735|NCT02027025|3002982|Superiority|||||||0.8991|||||||Chi-squared||||
1634736|NCT02027025|3002983|Superiority|||||||0.7491|||||||Chi-squared||||
1634737|NCT02027025|3002983|Superiority|||||||0.3815|||||||Chi-squared||||
1634738|NCT02027025|3002984|Superiority||LS mean difference|-0.2|Standard Error of the Mean|0.19||0.2994|2-Sided|95.0|-0.58|0.18|||ANCOVA||||
1634739|NCT02027025|3002984|Superiority||LS mean difference|-0.19|Standard Error of the Mean|0.18||0.3013|2-Sided|95.0|-0.56|0.17|||ANCOVA||||
1634740|NCT02027025|3002985|Superiority||LS mean difference|-0.47|Standard Error of the Mean|0.65||0.4704|2-Sided|95.0|-1.76|0.82|||ANCOVA||||
1634741|NCT02027025|3002985|Superiority||LS mean difference|-0.48|Standard Error of the Mean|0.64||0.4532|2-Sided|95.0|-1.73|0.78|||ANCOVA||||
1634742|NCT02026258|3002992|Other||Fisher chi square|0.49|||<|0.05|2-Sided||||||Fisher Exact|||Recommend procedure to a friend|
1634743|NCT02026258|3002992|Other||Fisher chi square|0.99|||<|0.05|2-Sided||||||Fisher Exact|||Undergo procedure again|
1634744|NCT02026258|3002992|Other||Fisher chi square|0.71|||<|0.05|2-Sided||||||Fisher Exact|Use of Medications|||
1634745|NCT02026258|3002993|Other||Mean Difference (Final Values)|0.69|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)|||Satisfaction with procedure|
1634746|NCT02026258|3002993|Other||Mean Difference (Final Values)|0.87|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)|||Ease of Procedure|
1634747|NCT02026258|3002994|Other||Mean Difference (Final Values)|0.76|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)|||VAS T3|
1634748|NCT02026258|3002994|Other||Mean Difference (Final Values)|0.19|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)|||VAS T2|
1634749|NCT02026258|3002994|Other||Mean Difference (Final Values)|0.19|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)|||VAS T1|
1634750|NCT02026258|3002994|Other||Mean Difference (Final Values)|0.3|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)|||VAS T0|
1634751|NCT02026258|3002995|Other||Mean Difference (Final Values)|0.52|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)|||Based on previous findings, it takes approximately 117 ± 46 days for complete alignment of the mandibular anterior teeth in subjects with severe crowding treated without extractions. For a clinically significant 40% faster alignment in the piezotome-corticision group compared to the control group at an alpha-level (p = 0.05) and desired power of 80%, a sample size of 28 subjects (14 per group) was required. Twenty subjects per group assuming an overall attrition rate of 28%.|
1634752|NCT02026141|3003001|Superiority or Other||||||<|0.05|||||||ANCOVA||||
1634753|NCT02026011|3003007|Superiority or Other|||||||0.41||||||Medication by genotype interaction: F(1, 70) = 0.68, p = 0.41.|Poisson||||
1634754|NCT02026011|3003007|Superiority or Other|||||||0.02||||||Genotype effect: F(1, 71) = 5.79, p = 0.02|Poisson||||
1634755|NCT02026011|3003007|Superiority or Other|||||||0.14||||||Medication effect: F(1,71) = 2.24, p = 0.14|Poisson Regression||||
1634756|NCT02026011|3003009|Superiority or Other|||||||0.19||||||Medication by genotype by BrAC interaction: b = 0.28, SE = 0.21, t = 1.30, p = 0.19|Mixed Models Analysis||||
1634757|NCT02026011|3003009|Superiority or Other|||||||0.47||||||Medication by genotype interaction: b = -0.21, SE = 0.29, t = -0.72, p = 0.47|Mixed Models Analysis||||
1634758|NCT02026011|3003009|Superiority or Other|||||||0.04||||||BrAC effect: b = 0.30, SE = 0.15, t = 2.02, p = 0.04|Mixed Models Analysis||||
1634759|NCT02026011|3003009|Superiority or Other|||||||0.77||||||Genotype effect: b = -0.11, SE = 0.37, t = -0.30, p = 0.77|Mixed Models Analysis||||
1634760|NCT02026011|3003009|Superiority or Other|||||||0.55||||||Medication effect: b = 0.14, SE = 0.23, t = 0.61, p = 0.55|Mixed Models Analysis||||
1634761|NCT02026011|3003010|Superiority or Other|||||||0.05||||||Medication by genotype by BrAC interaction: b = -0.32, SE = 0.16, t = -1.93, p = 0.05|Mixed Models Analysis||||
1634762|NCT02026011|3003010|Superiority or Other|||||||0.84||||||Medication by genotype interaction: b = 0.04, SE = 0.21, t = 0.20, p = 0.84|Mixed Models Analysis||||
1634763|NCT02026011|3003010|Superiority or Other|||||||0.09||||||Genotype effect: b = 0.37, SE = 0.22, t = 1.69, p = 0.09|Mixed Models Analysis||||
1634764|NCT02026011|3003010|Superiority or Other|||||||0.23||||||Medication effect: b = 0.16, SE = 0.13, t = 1.20, p = 0.23|Mixed Models Analysis||||
1634765|NCT02026011|3003011|Superiority or Other|||||||0.13||||||Medication by genotype by BrAC interaction: b = -0.20, SE = 0.13, t = -1.52, p = 0.13|Mixed Models Analysis||||
1634766|NCT02026011|3003011|Superiority or Other|||||||0.47||||||Medication by genotype interaction: b = 0.15, SE = 0.21, t = 0.73, p = 0.47|Mixed Models Analysis||||
1634767|NCT02026011|3003011|Superiority or Other|||||||0.04||||||BrAC effect: b = 0.13, SE = 0.06, t = 2.10, p = 0.04|Mixed Models Analysis||||
1634768|NCT02026011|3003011|Superiority or Other|||||||0.34||||||Genotype effect: b = 0.20, SE = 0.21, t = 0.96, p = 0.34|Mixed Models Analysis||||
1634769|NCT02026011|3003011|Superiority or Other|||||||0.39||||||Medication effect: b = -0.15, SE = 0.17, t = -0.86, p = 0.39|Mixed Models Analysis||||
1634770|NCT02024932|3003113|Superiority or Other||Geo-mean ratio|1.037||||0.0164|2-Sided|90.0|1.009|1.065|||ANCOVA||||
1634771|NCT02024867|3003116|Non-Inferiority or Equivalence|described previously|rate difference|0.0|||>|0.05|2-Sided|95.0|||||Chi-squared||||
1634772|NCT02024867|3003117|Non-Inferiority or Equivalence|described previously|Rate Difference|10.3||||0.046|2-Sided|95.0|0.8|19.9|||Chi-squared||||
1634773|NCT02024867|3003118|Non-Inferiority or Equivalence|described previously|Rate Difference|0.1|||>|0.05|2-Sided|95.0|-6.9|7.0|||Chi-squared||||
1634774|NCT02024867|3003119|Non-Inferiority or Equivalence|described previously|Rate Difference|10.1||||0.03|2-Sided|95.0|2.1|18.2|||Chi-squared||||
1634775|NCT02024867|3003120|Non-Inferiority or Equivalence|described previously|Rate Difference|10.7||||0.02|2-Sided|95.0|2.1|19.2|||Chi-squared||||
1634776|NCT02024867|3003121|Non-Inferiority or Equivalence|The sample size of 120 per group was calculated according to an assumed treatment cure rate of 95% with 10 days of antibiotics, and a non-inferiority margin of 7% (allowing up to 88% cure rate with 3 days of antibiotics), to achieve a power of 0.80 (alpha=0.05). An additional 25 patients were recruited to account for an estimated 10% lost to follow-up.|Rate Difference|4.0||||0.25|2-Sided|95.0|-1.5|9.5|||Chi-squared||||
1634777|NCT02024750|3003122|Other||Mean Difference (Net)|-0.006||||0.98|2-Sided|95.0|-0.384|0.373||The a priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms.|
1634778|NCT02024750|3003122|Other||Mean Difference (Net)|0.134||||0.3|2-Sided|95.0|-0.121|0.388||The a priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms.|
1634779|NCT02024750|3003123|Other||Mean Difference (Net)|-0.009||||0.97|2-Sided|95.0|-0.467|0.448||The a priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.|
1634780|NCT02024750|3003123|Other||Mean Difference (Net)|-0.037||||0.79|2-Sided|95.0|-0.312|0.237||The a priori threshold for statistical significance was p<0.05|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.|
1634781|NCT02024750|3003124|Other||Mean Difference (Net)|-0.074||||0.74|2-Sided|95.0|-0.517|0.369||The a priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the post-intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.|
1634782|NCT02024750|3003124|Other||Mean Difference (Net)|0.023||||0.87|2-Sided|95.0|-0.249|0.295||The a priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Positive values indicate a clinical benefit.|During the intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.|
1634783|NCT02024750|3003125|Other||Mean Difference (Net)|-0.01||||0.38|2-Sided|95.0|-0.034|0.013||The a priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Negative values indicate a clinical benefit.|During the post-intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.|
1634784|NCT02024750|3003125|Other||Mean Difference (Net)|0.005||||0.72|2-Sided|95.0|-0.021|0.03||The a priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline.|Negative values indicate a clinical benefit.|During the intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.|
1634785|NCT02024724|3003126|Superiority||Median Difference (Final Values)|-30.0||||0.196|2-Sided|95.0|-45.0|10.0|||Chi-squared||||
1634786|NCT02023983|3003152|Other|||||||1|||||||Fisher Exact||||
1634787|NCT02023983|3003153|Other|||||||0.765|||||||Fisher Exact||||
1634788|NCT02023879|3003165|Superiority or Other||Adjusted mean difference|-7.9||||0.0892|2-Sided|95.0|-17.1|1.2||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634789|NCT02023879|3003166|Superiority or Other||Adjusted mean difference|-19.6||||0.0002|2-Sided|95.0|-29.8|-9.4||Threshold for significance at 0.05 level.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634790|NCT02023879|3003167|Superiority or Other||Odds Ratio (OR)|141.5|||<|0.0001|2-Sided|95.0|22.2|9999.0||Threshold for significance at 0.05 level.|Regression, Logistic|LOCF approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to >9999)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634791|NCT02023879|3003168|Superiority or Other||Odds Ratio (OR)|126.0|||<|0.0001|2-Sided|95.0|20.0|9999.0||Threshold for significance at 0.05 level.|Regression, Logistic|LOCF approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo (Confidence interval should be read as 20.0 to >9999)|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634792|NCT02023879|3003169|Superiority or Other||Odds Ratio (OR)|354.7|||<|0.0001|2-Sided|95.0|36.2|3479.5||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634823|NCT02023697|3003236|Other||Hazard Ratio (HR)|1.057||||0.7047|2-Sided|80.0|0.878|1.272|||Log Rank||Arm B / Arm (A+C)||
1634793|NCT02023879|3003170|Superiority or Other||Odds Ratio (OR)|279.8|||<|0.0001|2-Sided|95.0|29.1|2690.1||Threshold for significance at 0.05 level.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634794|NCT02023879|3003171|Superiority or Other||LS Mean Difference|-26.3|||<|0.0001|2-Sided|95.0|-30.9|-21.7||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634795|NCT02023879|3003172|Superiority or Other||LS Mean Difference|-37.9|||<|0.0001|2-Sided|95.0|-43.9|-31.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634796|NCT02023879|3003173|Superiority or Other||LS Mean Difference|-38.2|||<|0.0001|2-Sided|95.0|-44.3|-32.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634797|NCT02023879|3003174|Superiority or Other||LS Mean Difference|-35.3|||<|0.0001|2-Sided|95.0|-39.8|-30.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634798|NCT02023879|3003175|Superiority or Other||LS Mean Difference|-51.7|||<|0.0001|2-Sided|95.0|-57.1|-46.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634799|NCT02023879|3003176|Superiority or Other||LS Mean Difference|-49.0|||<|0.0001|2-Sided|95.0|-54.9|-43.2||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634800|NCT02023879|3003177|Superiority or Other||LS Mean Difference|-48.6|||<|0.0001|2-Sided|95.0|-54.3|-42.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634801|NCT02023879|3003178|Superiority or Other||LS Mean Difference|-46.4|||<|0.0001|2-Sided|95.0|-52.4|-40.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634802|NCT02023879|3003179|Superiority or Other||LS Mean Difference|-58.6|||<|0.0001|2-Sided|95.0|-63.8|-53.4||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634803|NCT02023879|3003180|Superiority or Other||LS Mean Difference|-55.5|||<|0.0001|2-Sided|95.0|-61.1|-49.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634804|NCT02023879|3003181|Superiority or Other||LS Mean Difference|-48.4|||<|0.0001|2-Sided|95.0|-54.8|-41.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634805|NCT02023879|3003182|Superiority or Other||LS Mean Difference|-44.9|||<|0.0001|2-Sided|95.0|-51.8|-38.1||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1634806|NCT02023879|3003183|Superiority or Other||LS Mean Difference|-59.7|||<|0.0001|2-Sided|95.0|-65.6|-53.8||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|
1634807|NCT02023879|3003184|Superiority or Other||Least square (LS) mean difference|-56.4|||<|0.0001|2-Sided|95.0|-62.9|-49.9||Threshold for significance at 0.05 level.|Mixed Models Analysis||Alirocumab 150 mg Q4W/Up to 150 mg Q2W vs. Placebo|Alirocumab 150 mg Q4W/up to 150 mg Q2W was compared to placebo group using an appropriate contrast statement.|
1634808|NCT02023866|3003194|Other|||||||0.2941|||||||t-test, 2 sided|One-sample t-test||Section IV - Quality of Life Null hypothesis = change from baseline is 0.|
1634809|NCT02023866|3003194|Other|||||||0.0781|||||||Wilcoxin Signed Rank|||Section III - Current Clinical Assessment Null hypothesis = change from baseline is 0.|
1634810|NCT02023866|3003194|Other|||||||1|||||||Wilcoxin Signed Rank|||Section II - System Specific Involvement Null hypothesis = change from baseline is 0.|
1634811|NCT02023866|3003194|Other|||||||0.1875|||||||Wilcoxon Signed Rank|||Section I - Current Function Null hypothesis = change from baseline is 0.|
1634812|NCT02023697|3003202|Other||Hazard Ratio (HR)|0.863||||0.7214|2-Sided|80.0|0.505|1.475|||Log Rank||Arm C/Arm A||
1634813|NCT02023697|3003204|Other||Hazard Ratio (HR)|0.898||||0.6214|2-Sided|80.0|0.678|1.188|||Log Rank||Arm B/Arm (A+C)||
1634814|NCT02023697|3003210|Other||Hazard Ratio (HR)|1.134||||0.5754|2-Sided|80.0|0.85|1.514|||Log Rank||Arm C/Arm A||
1634815|NCT02023697|3003212|Other||Hazard Ratio (HR)|0.986||||0.9274|2-Sided|80.0|0.803|1.21|||Log Rank||Arm B/Arm (A+C)||
1634816|NCT02023697|3003216|Other||Hazard Ratio (HR)|1.059||||0.7896|2-Sided|80.0|0.804|1.396|||Log Rank||Arm C/Arm A||
1634817|NCT02023697|3003218|Other||Hazard Ratio (HR)|0.969||||0.8284|2-Sided|80.0|0.805|1.167|||Log Rank||Arm B/Arm (A+C)||
1634818|NCT02023697|3003222|Other||Hazard Ratio (HR)|1.549||||0.155|2-Sided|80.0|1.041|2.306|||Log Rank||Arm C/Arm A||
1634824|NCT02023125|3003260|Superiority or Other||Geometric Least Square Mean Ratio|109.0|||||2-Sided|90.0|95.3|126.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.|
1634825|NCT02023125|3003261|Superiority or Other||Geometric Least Square Mean Ratio|349.0|||||2-Sided|90.0|288.0|422.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.|
1634826|NCT02023125|3003262|Superiority or Other||Geometric Least Square Mean Ratio|122.0|||||2-Sided|90.0|110.0|136.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.|
1634827|NCT02023125|3003263|Superiority or Other||Geometric Least Square Mean Ratio|306.0|||||2-Sided|90.0|269.0|348.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.|
1634828|NCT02023125|3003266|Superiority or Other||Geometric Least Square Mean Ratio|110.0|||||2-Sided|90.0|96.3|126.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.|
1634829|NCT02023125|3003267|Superiority or Other||Geometric Least Square Mean Ratio|328.0|||||2-Sided|90.0|276.0|389.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.|
1634830|NCT02023125|3003268|Superiority or Other||Geometric Least Square Mean Ratio|102.0|||||2-Sided|90.0|87.0|119.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.|
1634831|NCT02023125|3003269|Superiority or Other||Geometric Least Square Mean Ratio|377.0|||||2-Sided|90.0|303.0|468.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.|
1634832|NCT02023125|3003270|Superiority or Other||Geometric Least Square Mean Ratio|122.0|||||2-Sided|90.0|109.0|136.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.|
1634833|NCT02023125|3003271|Superiority or Other||Geometric Least Square Mean Ratio|292.0|||||2-Sided|90.0|258.0|329.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and CIs.|
1634834|NCT02023125|3003272|Superiority or Other||Geometric Least Square Mean Ratio|116.0|||||2-Sided|90.0|103.0|132.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Alectinib + Esomeprazole/Alectinib Alone) and CIs.|
1634835|NCT02023125|3003273|Superiority or Other||Geometric Least Square Mean Ratio|270.0|||||2-Sided|90.0|228.0|320.0|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Treatment B/Treatment A) and confidence intervals (CIs).|
1634836|NCT02023112|3003279|Superiority or Other||percentage of participants with SVR12|75.0|||||2-Sided|95.0|61.2|85.1|||||Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.|"Among non-cirrhotic treatment-naïve participants, superiority of the 12-week treatment arm to a clinically relevant threshold.~LCB must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-IFN alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants."|
1634837|NCT02023112|3003279|Superiority or Other||percentage of participants with SVR12|91.5|||||2-Sided|95.0|80.1|96.6|||||Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.|"Among non-cirrhotic treatment-naïve participants, superiority of the 16-week treatment arm to a clinically relevant threshold.~Lower bound of 95% confidence interval (LCB) must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-interferon (IFN) alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants."|
1634838|NCT02022826|3003287|Other||precentage of agreement|92.0||||1|2-Sided|95.0|87.0|96.0|||McNemar||||
1634839|NCT02022826|3003288|Other||percentage of agreement|76.0||||0.0052|2-Sided|95.0|69.0|83.0|||McNemar||||
1634840|NCT02022748|3003289|Superiority or Other||Difference of Least Square Means|-0.5|||||2-Sided|90.0|-1.27|0.27|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment A - Treatment B.||
1634841|NCT02022748|3003289|Superiority or Other||Mean Difference (Net)|-1.05|||||2-Sided|90.0|-2.46|0.37|||||Treatment B - Treatment H.||
1634842|NCT02022748|3003289|Superiority or Other||Mean Difference (Net)|-1.07|||||2-Sided|90.0|-2.62|0.48|||||Treatment A - Treatment H.||
1634843|NCT02022748|3003290|Superiority or Other||Difference of Least Square Means|-0.36|||||2-Sided|90.0|-1.73|1.02|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment A - Treatment B.||
1634844|NCT02022748|3003290|Superiority or Other||Mean Difference (Net)|0.28|||||2-Sided|90.0|-0.96|1.52|||||Treatment B - Treatment H.||
1634845|NCT02022748|3003290|Superiority or Other||Mean Difference (Net)|-0.11|||||2-Sided|90.0|-0.97|0.75|||||Treatment A - Treatment H.||
1634846|NCT02022748|3003291|Other||Ratio of Geometric Least Square Means|93.13|||||2-Sided|90.0|80.31|108.0|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.||
1634847|NCT02022748|3003291|Other||Ratio of Geometric Least Square Means|114.37|||||2-Sided|90.0|91.19|143.45|||||Treatment H is the reference treatment.||
1634848|NCT02022748|3003291|Other||Ratio of Geometric Least Square Means|112.73|||||2-Sided|90.0|88.61|143.42|||||Treatment H is the reference treatment.||
1634849|NCT02022748|3003292|Other||Ratio of Geometric Least Square Means|90.35|||||2-Sided|90.0|77.55|105.27|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.||
1634850|NCT02022748|3003292|Other||Ratio of Geometric Least Square Means|148.76|||||2-Sided|90.0|115.07|192.32|||||Treatment H is the reference treatment.||
1634851|NCT02022748|3003292|Other||Ratio of Geometric Least Square Means|137.75|||||2-Sided|90.0|105.7|179.52|||||Treatment H is the reference treatment.||
1634852|NCT02022748|3003293|Other||Ratio of Geometric Least Square Means|82.29|||||2-Sided|90.0|68.43|98.96|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.||
1634853|NCT02022748|3003293|Other||Ratio of Geometric Least Square Means|136.27|||||2-Sided|90.0|95.38|194.7|||||Treatment H is the reference treatment.||
1634854|NCT02022748|3003293|Other||Ratio of Geometric Least Square Means|117.09|||||2-Sided|90.0|84.51|162.22|||||Treatment H is the reference treatment.||
1634855|NCT02022748|3003294|Other||Ratio of Geometric Least Square Means|90.1|||||2-Sided|90.0|78.07|103.98|||||A linear mixed model with sequence, period, and treatment as fixed effects, and subject-within-sequence as a random effect, was used to analyze the natural log-transformed values of the PK parameters. Treatment B is the reference treatment.||
1634856|NCT02022748|3003294|Other||Ratio of Geometric Least Square Means|161.38|||||2-Sided|90.0|122.52|212.58|||||Treatment H is the reference treatment.||
1634857|NCT02022748|3003294|Other||Ratio of Geometric Least Square Means|151.13|||||2-Sided|90.0|112.03|203.86|||||Treatment H is the reference treatment.||
1634858|NCT02022085|3003315|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||Qualities: Change from pre-op to 24 months|
1634859|NCT02022085|3003315|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||Spatial: Change from pre-op to 24 months|
1634860|NCT02022085|3003315|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||Speech: Change from pre-op to 24 months|
1634861|NCT02022085|3003315|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||Qualities: Change from pre-op to 6 months|
1634862|NCT02022085|3003315|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||Spatial: Change from pre-op to 6 months|
1634863|NCT02022085|3003315|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||Speech: Change from pre-op to 6 months|
1634864|NCT02022085|3003316|Superiority or Other||||||<|0.001|||||||Fisher’s non-parametric permutation test|||24 months: Global|
1634865|NCT02022085|3003316|Superiority or Other||||||<|0.84|||||||Fisher’s non-parametric permutation test|||24 months: Aversiveness|
1634866|NCT02022085|3003316|Superiority or Other||||||<|0.001|||||||Fisher’s non-parametric permutation test|||24 months: Reverberation|
1634867|NCT02022085|3003316|Superiority or Other||||||<|0.001|||||||Fisher’s non-parametric permutation test|||24 months: Background noise|
1634868|NCT02022085|3003316|Superiority or Other||||||<|0.001|||||||Fisher’s non-parametric permutation test|||24 months: Ease of communication|
1634869|NCT02022085|3003316|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||6 months: Global|
1634870|NCT02022085|3003316|Superiority or Other||||||<|0.69|||||||Fisher’s non-parametric permutation test|||6 months: Aversiveness|
1634871|NCT02022085|3003316|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||6 months: Reverberation|
1634872|NCT02022085|3003316|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||6 months: Background noise|
1634873|NCT02022085|3003316|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||6 months: Ease of communication|
1634874|NCT02022085|3003317|Superiority or Other|||||||0.02|||||||Fisher’s non-parametric permutation test|||24 months change in Pain|
1634875|NCT02022085|3003317|Superiority or Other|||||||0.92|||||||Fisher’s non-parametric permutation test|||24 months change in Cognition|
1634876|NCT02022085|3003317|Superiority or Other|||||||0.29|||||||Fisher’s non-parametric permutation test|||24 months change in Emotion|
1634877|NCT02022085|3003317|Superiority or Other|||||||0.5|||||||Wilcoxan Signed Rank Test|Fisher’s non-parametric permutation test failed to approximate p value so Wilcoxan Signed Rank Test instead||24 months change in Dexterity|
1634878|NCT02022085|3003317|Superiority or Other|||||||0.25|||||||Fisher’s non-parametric permutation test|||24 months change in Ambulation|
1634879|NCT02022085|3003317|Superiority or Other|||||||0.016|||||||Fisher’s non-parametric permutation test|||24 months change in Speech|
1634880|NCT02022085|3003317|Superiority or Other|||||||0.045|||||||Fisher’s non-parametric permutation test|||24 months change in Hearing|
1634881|NCT02022085|3003317|Superiority or Other|||||||0.63|||||||Fisher’s non-parametric permutation test|||24 months change in Vision|
1634882|NCT02022085|3003317|Superiority or Other|||||||0.088|||||||Fisher’s non-parametric permutation test|||24 months change in Comprehensive health state|
1634883|NCT02022085|3003317|Superiority or Other|||||||0.25|||||||Fisher’s non-parametric permutation test|||6 months change in Pain|
1634884|NCT02022085|3003317|Superiority or Other|||||||0.85|||||||Fisher’s non-parametric permutation test|||6 months change in Cognition|
1634885|NCT02022085|3003317|Superiority or Other|||||||0.43|||||||Fisher’s non-parametric permutation test|||6 months change in Emotion|
1634886|NCT02022085|3003317|Superiority or Other|||||||0.38|||||||Fisher’s non-parametric permutation test|||6 months change in Dexterity|
1634887|NCT02022085|3003317|Superiority or Other|||||||0.25|||||||Fisher’s non-parametric permutation test|||6 months change in Ambulation|
1634888|NCT02022085|3003317|Superiority or Other|||||||0.039|||||||Fisher’s non-parametric permutation test|||6 months change in Speech|
1634889|NCT02022085|3003317|Superiority or Other|||||||0.02|||||||Fisher’s non-parametric permutation test|||6 months change in Hearing|
1634890|NCT02022085|3003317|Superiority or Other|||||||0.88|||||||Fisher’s non-parametric permutation test|||6 months change in Vision|
1634891|NCT02022085|3003317|Superiority or Other|||||||0.088|||||||Fisher’s non-parametric permutation test|||6 months change in Comprehensive health state|
1634892|NCT02022085|3003318|Superiority or Other|||||||0.59|||||||Fisher’s non-parametric permutation test|||24 months Speech in Quiet at 80dB|
1634893|NCT02022085|3003318|Superiority or Other|||||||0.024|||||||Fisher’s non-parametric permutation test|||24 months Speech in Quiet at 65dB|
1634894|NCT02022085|3003318|Superiority or Other|||||||0.021|||||||Fisher’s non-parametric permutation test|||24 months Speech in Quiet at 50dB|
1634895|NCT02022085|3003318|Superiority or Other|||||||0.44|||||||Fisher’s non-parametric permutation test|||12 months Speech in Quiet at 80dB|
1634896|NCT02022085|3003318|Superiority or Other|||||||0.094|||||||Fisher’s non-parametric permutation test|||12 months Speech in Quiet at 65dB|
1634897|NCT02022085|3003318|Superiority or Other|||||||0.93|||||||Fisher’s non-parametric permutation test|||12 months Speech in Quiet at 50dB|
1634898|NCT02022085|3003318|Superiority or Other|||||||0.65|||||||Fisher’s non-parametric permutation test|||6 months Speech in Quiet at 80dB|
1634899|NCT02022085|3003318|Superiority or Other|||||||0.16|||||||Fisher’s non-parametric permutation test|||6 months Speech in Quiet at 65dB|
1634900|NCT02022085|3003318|Superiority or Other|||||||0.43|||||||Fisher’s non-parametric permutation test|||6 months Speech in Quiet at 50dB|
1634901|NCT02022085|3003319|Superiority or Other|||||||0.31|||||||Fisher’s non-parametric permutation test|||24 months: Speech in Noise with Baha Attract vs Softband|
1634902|NCT02022085|3003319|Superiority or Other|||||||0.19|||||||Fisher’s non-parametric permutation test|||12 months: Speech in Noise with Baha Attract vs Softband|
1634903|NCT02022085|3003319|Superiority or Other|||||||0.46|||||||Fisher’s non-parametric permutation test|||6 months: Speech in Noise with Baha Attract vs Softband|
1634904|NCT02022085|3003320|Superiority or Other|||||||0.0051|||||||Fisher’s non-parametric permutation test|||6000Hz: 24 months with Baha Attract vs Softband|
1634905|NCT02022085|3003320|Superiority or Other|||||||0.064|||||||Fisher’s non-parametric permutation test|||4000Hz: 24 months with Baha Attract vs Softband|
1634906|NCT02022085|3003320|Superiority or Other|||||||0.064|||||||Fisher’s non-parametric permutation test|||3000Hz: 24 months with Baha Attract vs Softband|
1634907|NCT02022085|3003320|Superiority or Other|||||||0.57|||||||Fisher’s non-parametric permutation test|||2000Hz: 24 months with Baha Attract vs Softband|
1634908|NCT02022085|3003320|Superiority or Other|||||||0.22|||||||Fisher’s non-parametric permutation test|||1000Hz: 24 months with Baha Attract vs Softband|
1634909|NCT02022085|3003320|Superiority or Other|||||||0.26|||||||Fisher’s non-parametric permutation test|||500Hz: 24 months with Baha Attract vs Softband|
1634910|NCT02022085|3003320|Superiority or Other|||||||0.0051|||||||Fisher’s non-parametric permutation test|||250Hz: 24 months with Baha Attract vs Softband|
1634911|NCT02022085|3003321|Superiority or Other|||||||0.0013|||||||Fisher’s non-parametric permutation test|||6000Hz: 12 months with Baha Attract vs Softband|
1634912|NCT02022085|3003321|Superiority or Other|||||||0.035|||||||Fisher’s non-parametric permutation test|||4000Hz: 12 months with Baha Attract vs Softband|
1634913|NCT02022085|3003321|Superiority or Other|||||||0.015|||||||Fisher’s non-parametric permutation test|||3000Hz: 12 months with Baha Attract vs Softband|
1634914|NCT02022085|3003321|Superiority or Other|||||||0.78|||||||Fisher’s non-parametric permutation test|||2000Hz: 12 months with Baha Attract vs Softband|
1634915|NCT02022085|3003321|Superiority or Other|||||||0.71|||||||Fisher’s non-parametric permutation test|||1000Hz: 12 months with Baha Attract vs Softband|
1634916|NCT02022085|3003321|Superiority or Other|||||||0.066|||||||Fisher’s non-parametric permutation test|||500Hz: 12 months with Baha Attract vs Softband|
1634917|NCT02022085|3003321|Superiority or Other|||||||0.11|||||||Fisher’s non-parametric permutation test|||250Hz: 12 months with Baha Attract vs Softband|
1634918|NCT02022085|3003322|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||6000Hz: 6 months with Baha Attract vs Softband|
1634919|NCT02022085|3003322|Superiority or Other||||||<|0.012|||||||Fisher’s non-parametric permutation test|||4000Hz: 6 months with Baha Attract vs Softband|
1634920|NCT02022085|3003322|Superiority or Other||||||<|0.039|||||||Fisher’s non-parametric permutation test|||3000Hz: 6 months with Baha Attract vs Softband|
1634921|NCT02022085|3003322|Superiority or Other||||||<|0.64|||||||Fisher’s non-parametric permutation test|||2000Hz: 6 months with Baha Attract vs Softband|
1634922|NCT02022085|3003322|Superiority or Other||||||<|0.22|||||||Fisher’s non-parametric permutation test|||1000Hz: 6 months with Baha Attract vs Softband|
1634923|NCT02022085|3003322|Superiority or Other||||||<|0.0004|||||||Fisher’s non-parametric permutation test|||500Hz: 6 months with Baha Attract vs Softband|
1634924|NCT02022085|3003322|Superiority or Other||||||<|0.34|||||||Fisher’s non-parametric permutation test|||250Hz: 6 months with Baha Attract vs Softband|
1634925|NCT02022085|3003323|Superiority or Other|||||||0.89|||||||Fisher’s non-parametric permutation test|||24 months with Baha Attract vs Softband: change in PTA4|
1634926|NCT02022085|3003323|Superiority or Other|||||||0.84|||||||Fisher’s non-parametric permutation test|||12 months with Baha Attract vs Softband: change in PTA4|
1634927|NCT02022085|3003323|Superiority or Other|||||||0.38|||||||Fisher’s non-parametric permutation test|||6 months with Baha Attract vs Softband: change in PTA4|
1634928|NCT02022085|3003324|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||24 months: Speech in quiet at 80dB|
1634929|NCT02022085|3003324|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||24 months: Speech in quiet at 65dB|
1634930|NCT02022085|3003324|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||24 months: Speech in quiet at 50dB|
1634931|NCT02022085|3003324|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||12 months: Speech in quiet at 80dB|
1634932|NCT02022085|3003324|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||12 months: Speech in quiet at 65dB|
1634933|NCT02022085|3003324|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||12 months: Speech in quiet at 50dB|
1634934|NCT02022085|3003324|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||6 months: Speech in quiet at 80dB|
1634935|NCT02022085|3003324|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||6 months: Speech in quiet at 65dB|
1634936|NCT02022085|3003324|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||6 months: Speech in quiet at 50dB|
1634937|NCT02022085|3003325|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||Speech in Noise, 24 months Baha Attract vs Unaided|
1634938|NCT02022085|3003325|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||Speech in Noise, 12 months Baha Attract vs Unaided|
1634939|NCT02022085|3003325|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||Speech in Noise, 6 months Baha Attract vs Unaided|
1634940|NCT02022085|3003326|Superiority or Other||||||<|0.0001||||||All comparisons to the Unaided situation were p=<0.0001.|Fisher’s non-parametric permutation test|||Baha Attract after 6 months vs Unaided situation Pre-Op|
1634941|NCT02022085|3003327|Superiority or Other||||||<|0.0001||||||All comparisons to the Unaided situation were p=<0.0001.|Fisher’s non-parametric permutation test|||Baha Attract after 12 months vs Unaided situation Pre-Op|
1634942|NCT02022085|3003328|Superiority or Other||||||<|0.0001||||||All comparisons to the Unaided situation were p=<0.0001.|Fisher’s non-parametric permutation test|||Baha Attract after 24 months vs Unaided situation Pre-Op|
1634943|NCT02022085|3003329|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||PTA4 24 months with Baha Attract vs Unaided|
1634944|NCT02022085|3003329|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||PTA4 12 months with Baha Attract vs Unaided|
1634945|NCT02022085|3003329|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||PTA4 6 months with Baha Attract vs Unaided|
1634946|NCT02022007|3003333|Superiority or Other||||||>|0.05|||||||Fisher Exact||||
1634947|NCT02022007|3003334|Superiority or Other|||||||0.006|||||||ANOVA||||
1634948|NCT02022007|3003335|Superiority or Other|||||||0.006|||||||ANOVA||||
1634949|NCT02022007|3003336|Superiority or Other|||||||0.026|||||||ANOVA||||
1634950|NCT02022007|3003337|Superiority or Other|||||||0.006|||||||ANOVA||||
1634951|NCT02022007|3003338|Superiority or Other|||||||0.006|||||||ANOVA||||
1634952|NCT02022007|3003339|Superiority or Other|||||||0.025|||||||ANOVA||||
1634953|NCT02022007|3003340|Superiority or Other|||||||0.003|||||||ANOVA||||
1634954|NCT02022007|3003341|Superiority or Other|||||||0.038|||||||ANOVA||||
1634955|NCT02022007|3003342|Superiority or Other||||||<|0.0001|||||||ANOVA|n||Pretreatment fasting glucose levels were compared with post-treatment levels|
1634956|NCT02022007|3003343|Superiority or Other|||||||0.02|||||||ANOVA|||This was a Subjects (SS)/Groups repeated measures design|
1634957|NCT02022007|3003344|Superiority or Other|||||||0.007|||||||McNemar|||Study change from dysglycemia to normal glucose state|
1634958|NCT02021656|3003367|Superiority||||||<|0.001|||||||Binomial Exact Test|||A sample size of 100 Chinese participants in the treatment naive group provided at least 90% power to detect a 17% improvement in SVR12 rate from the historical control rate of 57% using 2-sided exact one-sample binomial test at significant level of 0.05.|
1634959|NCT02021565|3003374|Superiority|||||||0.729|||||||ANOVA||||
1634960|NCT02021565|3003375|Superiority|||||||0.891|||||||ANOVA|||Analysis 2 is for the Veteran reported confidence that he/she can perform 10 transfer tasks independently.|
1634961|NCT02021565|3003375|Superiority|||||||0.547|||||||ANOVA|||Analysis 1 is for the Veteran care recipient reported task efficacy|
1634962|NCT02021565|3003376|Superiority|Alpha = .025||||||0.223|||||||ANOVA|||Analysis 2 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks independently.|
1634963|NCT02021565|3003376|Superiority|||||||0.973||||||alpha = 0.025|ANOVA|Repeated measures||Analysis 1 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks with assistance from the informal caregiver.|
1634964|NCT02021292|3003381|Superiority||ratio of geometric means|0.79||||0.0045|2-Sided|95.0|0.67|0.93||To control for multiplicity across the primary and secondary endpoints, all secondary endpoints were analyzed hierarchically based on the order and significance as pre-specified in the protocol eliminating further adjustment for multiple comparisons.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||The same statistical model as for the predefined analysis was applied excluding the 4 subjects with incorrect hemodynamic values. The null hypothesis (change of PVR at rest in Week 16 in percent of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary efficacy endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed % of baseline PVR at rest at Week 16.|
1635012|NCT02019472|3003563|Superiority or Other||Percentage Difference|12.8|||<|0.001|2-Sided|95.0|5.9|19.7|||Cochran-Mantel-Haenszel||||
1635013|NCT02019472|3003563|Superiority or Other||Percentage Difference|5.4|||<|0.086|2-Sided|95.0|-0.7|11.4|||Cochran-Mantel-Haenszel||||
1635014|NCT02019472|3003564|Superiority or Other||Percentage Difference|3.6||||0.464|2-Sided|95.0|-6.0|13.1|||Cochran-Mantel-Haenszel||||
1635015|NCT02019472|3003564|Superiority or Other||Percentage Difference|-4.8||||0.306|2-Sided|95.0|-14.1|4.4|||Cochran-Mantel-Haenszel||||
1634965|NCT02021292|3003382|Superiority||ratio of geometric means|0.81||||0.0084|2-Sided|95.0|0.69|0.95||To control for multiplicity across the primary and secondary endpoints, all secondary endpoints were analyzed hierarchically based on the order and significance as pre-specified in the protocol eliminating further adjustment for multiple comparisons.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||The same statistical model as for the predefined analysis was applied using corrected hemodynamic values for the 4 subjects with data corrections. The null hypothesis (change of PVR at rest in Week 16 in percent of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary efficacy endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed % of baseline PVR at rest at Week 16.|
1634966|NCT02021292|3003383|Superiority||Odds Ratio (OR)|0.212||||0.0962|2-Sided|95.0|0.001|1.464|||ANCOVA|||The null hypothesis is the odds of worsening are the same in the placebo and the macitentan group. Logistic regression is used for Treatment Group vs. Placebo comparison to generate odds ratio, confidence levels, and p-values with treatment and WHO functional class at baseline as factors in the model.|
1634967|NCT02021292|3003384|Superiority||least squares (LS) mean difference|-0.39||||0.3492|2-Sided|95.0|-1.21|0.43|||ANCOVA|||The null hypothesis is that the mean change from baseline is the same in the placebo and the macitentan group. Statistical model is Analysis of Covariance including Borg dyspnea index at baseline as a covariate, with Treatment as factor in the model.|
1634968|NCT02021292|3003385|Superiority||least squares (LS) mean difference|34.04||||0.0326|2-Sided|95.0|2.9|65.2|||ANCOVA|||The null hypothesis is that the mean change from baseline in 6MWD at Week 24 is the same in the placebo and the macitentan group. Statistical model is ANCOVA including 6MWD at baseline as a covariate, with treatment as factor in the model.|
1634969|NCT02021292|3003386|Superiority||ratio of geometric means|0.84||||0.041|2-Sided|95.0|0.7|0.99||To control for multiplicity across the primary and secondary endpoints, all secondary endpoints were analyzed hierarchically based on the order and significance as pre-specified in the protocol eliminating further adjustment for multiple comparisons.|ANCOVA|ANCOVA model on log-transformed % of baseline PVR at Week 16 adjusted by treatment as a factor and log transformed PVR at baseline as a covariate.||The null hypothesis (change of PVR at rest in Week 16 in percent of baseline PVR in subjects treated with placebo or macitentan is the same) is tested on the primary endpoint by means of an analysis of covariance (ANCOVA) model on the log(e) transformed % of baseline PVR at rest at Week 16.|
1634970|NCT02020889|3003412|Other||Odds Ratio (OR)|11.39||||0.003|2-Sided|95.0|2.35|55.24|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region.|Mepolizumab 300mg/Placebo||
1634971|NCT02020889|3003413|Other||Odds Ratio (OR)|7.19|||<|0.001|2-Sided|95.0|2.6|19.87|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo||
1634972|NCT02020889|3003414|Other||Odds Ratio (OR)|5.31|||<|0.001|2-Sided|95.0|2.63|10.74|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo||
1634973|NCT02020889|3003415|Other||Odds Ratio (OR)|19.65||||0.007|2-Sided|95.0|2.3|167.93|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo||
1634974|NCT02020889|3003416|Other||Odds Ratio (OR)|0.2|||<|0.001|2-Sided|95.0|0.09|0.41|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo||
1634975|NCT02020889|3003417|Other||Hazard Ratio (HR)|0.322|||<|0.001|2-Sided|95.0|0.206|0.502|||Cox Proportional Hazard regression|Cox proportional hazards model with covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo||
1634976|NCT02020889|3003418|Other||Odds Ratio (OR)|16.74|||<|0.001|2-Sided|95.0|3.61|77.56|||Regression, Logistic|Logistic regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region|Mepolizumab 300mg/Placebo||
1634977|NCT02020889|3003419|Other||Odds Ratio (OR)|5.91|||<|0.001|2-Sided|95.0|2.68|13.03|||Proportional odds regression model|Proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score, region|Mepolizumab 300mg/Placebo||
1634978|NCT02020785|3003422|Superiority||mean difference (during each period)|-0.8||||0.05|2-Sided|95.0|-2.7|1.0||For each outcome, a p value < 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||||
1634979|NCT02020785|3003423|Superiority||mean difference (during each period)|-1.1||||0.05|2-Sided|95.0|-4.1|1.9||For each outcome, a p value < 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||||
1634980|NCT02020785|3003424|Superiority||Mean Difference (Final Values)|0.034||||0.05|2-Sided|95.0|-0.059|0.136||For each outcome, a p value < 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||Estimate (3.4%, 95% CI: -5.9%, 13.6%) is the estimated difference between end of higher phosphorus period and end of lower phosphorus period from mixed effects analyses for log-transformed fibroblast growth factor 23||
1635016|NCT02019472|3003565|Superiority or Other||Least Square (LS) mean difference|-0.39|||=|0|2-Sided|95.0|-0.69|-0.08|||ANCOVA||||
1635017|NCT02019472|3003565|Superiority or Other||LS mean difference|-0.76|||<|0.001|2-Sided|95.0|-1.07|-0.46|||ANCOVA||||
1635018|NCT02019420|3003568|Other|Difference in ME-2 favorable response (tedizolid - linezolid)|Difference in clinical success|-13.7|||||2-Sided|95.0|-26.2|-1.2|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.||
1635019|NCT02019420|3003569|Other|Difference in mITT favorable response (tedizolid - linezolid)|Difference in clinical success|-12.5|||||2-Sided|95.0|-21.5|-3.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.||
1635102|NCT02016482|3003775|Superiority or Other||LS Mean Difference|-27.7|||<|0.001|2-Sided|95.0|-33.9|-21.6||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1634981|NCT02020785|3003425|Superiority|Main analyses were intention-to-treat using mixed effects models allowing intercepts to vary for each individual. Carryover effects were examined by using treatment by assignment-order interaction terms. Pre-specified sensitivity analyses were conducted excluding patients who were non-compliant, prior to data analysis: 1st, noncompliance based on missing product pickups and follow-up visits; 2nd, suspected poor compliance (< 250 mg difference between the higher and lower period).]|Mean Difference (Final Values)|0.143||||0.05|2-Sided|95.0|-0.025|0.34||For each outcome, a p value < 0.05 was considered statistically significant without adjustment for multiple comparisons.|Mixed Models Analysis||Estimate (14.3%, 95% CI: -2.5%, 34.0%) is the estimated difference between end of higher phosphorus period and end of lower phosphorus period from mixed effects analyses for log-transformed 24-hour urine albumin excretion|Sample size for this study was calculated using the xsampsi module in STATA, based on a previous study with repeat 24-hour urine collections (standard deviation, 1.04). At an α level of 0.05, we anticipated that a sample size of 30 participants with mean albuminuria of 100 mg/d would result in >80% power to detect a 13% difference in log- transformed albuminuria between the higher and lower phosphorus additive periods.|
1634982|NCT02020408|3003448|Superiority||||||<|0.05||||||The p value was calculated and adjusted for multiple comparisons (Bonferroni).|General Linear Model|||A General Linear Model using log([11C]raclopride BPND) after amphetamine administration as dependent variable and Diagnostic Group as independent variable was used. Baseline (before amphetamine administration) [11C]raclopride BPND was used as covariate.|
1634983|NCT02020408|3003449|Superiority||||||>|0.05||||||The p value was calculated and adjusted for multiple comparisons (Bonferroni).|ANOVA||||
1634984|NCT02020031|3003478|Superiority or Other||||||<|0.0001|||||||ANOVA|||Comparison at approximately 180 minutes, adjusted by BMI, age, and length of surgical procedure.|
1634985|NCT02020031|3003478|Superiority or Other||||||<|0.0001|||||||ANOVA|||Comparison at approximately 150 minutes, adjusted by BMI, age, and length of surgical procedure.|
1634986|NCT02020031|3003478|Superiority or Other||||||<|0.0001|||||||ANOVA|||Comparison at approximately 115 minutes, adjusted by BMI, age, and length of surgical procedure.|
1634987|NCT02020031|3003478|Superiority or Other||||||<|0.0001|||||||ANOVA|||Comparison at approximately 50 minutes, adjusted by BMI, age, and length of surgical procedure.|
1634988|NCT02020031|3003478|Superiority or Other||||||<|0.0001|||||||ANOVA|||Comparison at approximately 30 minutes, adjusted by BMI, age, and length of surgical procedure.|
1634989|NCT02020031|3003478|Superiority or Other||||||<|0.0001|||||||ANOVA|||Comparison at approximately 3 minutes, adjusted by BMI, age, and length of surgical procedure.|
1634990|NCT02020018|3003481|Superiority|||||||0.55|||||||Fisher Exact||||
1634991|NCT02019758|3003500|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1634992|NCT02019758|3003501|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1634993|NCT02019758|3003502|Superiority||||||<|0.001|||||||Chi-squared||||
1634994|NCT02019758|3003503|Superiority||Hazard Ratio (HR)|1.04|||||2-Sided|95.0|0.52|2.08|||||||
1634995|NCT02019758|3003508|Superiority|||||||0.7|||||||t-test, 2 sided|||The mean DSQ scores will be compared between the OVB and MDI groups using a two-sample t-test.|
1634996|NCT02019758|3003509|Superiority|||||||0.31|||||||t-test, 2 sided|||The mean post-treatment maximum eosinophil count will be compared between the OVB and MDI groups using a two-sample t-test.|
1634997|NCT02019719|3003527|Superiority or Other||MAD (mg)|8.65|||||2-Sided|95.0|6.51|11.44|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1634998|NCT02019719|3003527|Superiority or Other||TD (mg)|3.9|||||2-Sided|95.0|2.2|5.63|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1634999|NCT02019719|3003527|Superiority or Other||MED (mg)|1.98|||||2-Sided|95.0|0.75|3.41|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1635000|NCT02019719|3003527|Superiority or Other||Var|0.66|||||2-Sided|95.0|0.5|0.88|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1635001|NCT02019719|3003527|Superiority or Other||Gamma|1.13|||||2-Sided|95.0|0.7|1.68|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1635002|NCT02019719|3003527|Superiority or Other||Emax (g/dL)|5.88|||||2-Sided|95.0|3.2|8.61|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1635003|NCT02019719|3003527|Superiority or Other||ED50 (mg)|21.88|||||2-Sided|95.0|9.99|42.64|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1635004|NCT02019719|3003527|Superiority or Other||E0 (g/dL)|-1.37|||||2-Sided|95.0|-1.72|-1.03|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1635005|NCT02019563|3003540|Superiority or Other|||||||0.11||||||The p-value represents the survival rate from the Kaplan-Meier survival analysis from 6 to 36 months.|Log Rank||||
1635006|NCT02019563|3003541|Superiority or Other|||||||0.64|||||||Fisher Exact|||A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.|
1635007|NCT02019563|3003542|Superiority or Other|||||||0.51|||||||Fisher Exact|||A binary logistic generalized estimating equation (GEE) model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups for radiographic and clinical outcomes.|
1635008|NCT02019563|3003543|Superiority or Other||Odds Ratio (OR)|0.6||||0.38|2-Sided|95.0|0.19|1.89|||Chi-squared|||Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.|
1635009|NCT02019563|3003544|Superiority or Other||Odds Ratio (OR)|0.34||||0.15|2-Sided|95.0|0.08|1.49|||Chi-squared|||Radiographic outcomes were compared using univariate repeated measures logistic regression. A binary logistic generalized estimating equation model was used to analyze predictor variables such as age, gender, tooth and treatment provider between the treatment groups.|
1635010|NCT02019472|3003562|Superiority or Other||Percentage Difference|2.4||||0.644|2-Sided|95.0|-7.6|12.3|||Cochran-Mantel-Haenszel||||
1635011|NCT02019472|3003562|Superiority or Other||Percentage Difference|-2.7||||0.603|2-Sided|95.0|-12.8|7.4|||Cochran-Mantel-Haenszel||||
1635020|NCT02019420|3003570|Other|Difference in ME-1 favorable response (tedizolid - linezolid)|Difference in clinical success|-13.1|||||2-Sided|95.0|-21.7|-4.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.||
1635021|NCT02019420|3003571|Other|Difference in mITT favorable response (tedizolid - linezolid)|Difference in clinical success|-13.1|||||2-Sided|95.0|-21.7|-4.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.||
1635022|NCT02019420|3003572|Other|Difference in MRSA mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|3.1|||||2-Sided|95.0|-12.8|18.9|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.||
1635023|NCT02019420|3003573|Other|Difference in MSSA mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|-1.5|||||2-Sided|95.0|-12.5|9.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.||
1635024|NCT02019420|3003574|Other|Difference in CE clinical success (tedizolid - linezolid)|Difference in clinical success|-6.5|||||2-Sided|95.0|-15.1|2.1|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.||
1635025|NCT02019420|3003575|Other|Difference in ITT clinical success (tedizolid - linezolid)|Difference in clinical success|-7.6|||||2-Sided|95.0|-14.7|-0.5|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.||
1635026|NCT02019420|3003576|Other|Difference in mITT all-cause mortality (linezolid - tedizolid)|Difference in all-cause mortality|-1.6|||||2-Sided|95.0|-10.3|7.1|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.||
1635027|NCT02019420|3003577|Non-Inferiority|Difference in ITT all-cause mortality (linezolid - tedizolid). Noninferiority is declared when the lower bound of the 95% CI > -10.|Difference in all-cause mortality|-1.8|||||2-Sided|95.0|-8.2|4.7|||||Difference and 95% CI were calculated with the Miettinen and Nurminen method without stratification.||
1635028|NCT02019264|3003592|Superiority||Least square (LS) Mean Difference (Net)|-0.9036||||0.2976|2-Sided|95.0|-1.2908|-0.5163||P value was based on a mixed-effects model (unstructured covariance matrix) with repeated measures with treatment, month and treatment by month interaction as factors and baseline pulmonary arterial systolic pressure and baseline BMI as covariates.|Mixed-effects model||||
1635029|NCT02019264|3003593|Superiority||Odds Ratio (OR)|1.31||||0.7249|2-Sided|95.0|0.29|5.98||P-value was based on logistic regression including treatment as a factor and baseline BMI as a covariate.|Regression, Logistic||||
1635030|NCT02019264|3003594|Superiority||Odds Ratio (OR)|1.21||||0.5015|2-Sided|95.0|0.69|2.11||P-value was based on logistic regression including treatment as a factor and baseline body mass index (BMI) as a covariate.|Regression, Logistic||||
1635031|NCT02019264|3003595|Superiority|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.182||||0.0297|2-Sided|95.0|1.017|1.375|||Primary Analytic Method||||
1635032|NCT02019264|3003596|Superiority||Hazard Ratio (HR)|0.855||||0.0082|2-Sided|95.0|0.762|0.96|||Primary Analytic Method||||
1635033|NCT02019264|3003597|Superiority|Hazard ratio on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|0.904||||0.3661|2-Sided|95.0|0.727|1.125|||Primary Analytic Method||||
1635034|NCT02019264|3003598|Superiority|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.869||||0.0054|2-Sided|95.0|0.787|0.959|||Primary Analytic Method||||
1635035|NCT02019264|3003599|Superiority||Least square (LS) Mean Difference (Net)|-0.39|||<|0.0001|2-Sided|95.0|-0.43|-0.35||P-value was based on analysis of covariance (ANCOVA) model with treatment and stratification variable (presence of established CV disease or CV risk factors without established CV disease) as factors, and baseline HbA1c, as a covariate.|ANCOVA||||
1635036|NCT02019264|3003600|Superiority|Hazard ratio was based on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|0.773||||0.0116|2-Sided|95.0|0.633|0.944|||Primary Analytic Method||||
1635037|NCT02019264|3003601|Superiority|Hazard ratio was based on a Cox regression model including treatment as covariate.|Hazard Ratio (HR)|1.124||||0.181|2-Sided|95.0|0.947|1.333|||Primary Analytic Method||||
1635038|NCT02019264|3003602|Superiority|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.082||||0.4212|2-Sided|95.0|0.893|1.31|||Primary Analytic Method||||
1635039|NCT02019264|3003603|Superiority|Coronary Revascularization: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.981||||0.7817|2-Sided|95.0|0.856|1.125|||Primary Analytic Method||||
1635040|NCT02019264|3003603|Superiority|Heart Failure: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.952||||0.6758|2-Sided|95.0|0.757|1.197|||Primary Analytic Method||||
1635041|NCT02019264|3003603|Superiority|Hospitalization for Unstable Angina: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|1.163||||0.3243|2-Sided|95.0|0.861|1.571|||Primary Analytic Method||||
1635042|NCT02019264|3003603|Non-Inferiority|Cardiovascular Death: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.|Hazard Ratio (HR)|1.045||||0.0262|2-Sided|97.5|0.778|1.404|||Primary Analytic Method||||
1635043|NCT02019264|3003603|Non-Inferiority|Time to Stroke: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% CI refers to the upper limit of the displayed 2-sided 95% CI.|Hazard Ratio (HR)|0.856||||0.0005|2-Sided|97.5|0.639|1.145|||Primary Analytic Method||||
1635044|NCT02019264|3003603|Non-Inferiority|Myocardial Infarction: Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. 97.5% confidence interval refers to the upper limit of the displayed 2-sided 95% confidence interval.|Hazard Ratio (HR)|0.991||||0.0001|2-Sided|97.5|0.824|1.191|||Primary Analytic Method||||
1635045|NCT02019264|3003604|Superiority|Hazard ratio was based on Cox-regression model including treatment as covariate.|Hazard Ratio (HR)|0.807||||0.038|2-Sided|95.0|0.659|0.988|||Primary Analytic Method||||
1635046|NCT02019264|3003605|Superiority|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates.|Hazard Ratio (HR)|0.969||||0.5464|2-Sided|95.0|0.873|1.074|||Primary Analytic Method||||
1635047|NCT02019264|3003606|Non-Inferiority|Hazard ratio was based on Cox-regression model including treatment and CV strata as covariates. MACE met non-inferiority when the one-sided upper bound of 97.5% confidence interval of the HR was less than 1.4 (the non-inferiority margin).|Hazard Ratio (HR)|1.005||||0.0001|2-Sided|97.5|0.842|1.198|||Primary Analytic Method||||
1635048|NCT02019108|3003607|Superiority||Mean Difference (Final Values)|0.03||||0.897|2-Sided|95.0|-0.43|0.49||a priori threshold for statistical significance <0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.|
1635049|NCT02019108|3003607|Superiority||Mean Difference (Final Values)|-0.03||||0.876|2-Sided|95.0|-0.5|0.43||a priori threshold for statistical significance <0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.|
1635050|NCT02019108|3003608|Superiority||Mean Difference (Final Values)|-0.11||||0.737|2-Sided|95.0|-0.76|0.54||a priori threshold for statistical significance <0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.|
1635051|NCT02019108|3003608|Superiority||Mean Difference (Final Values)|0.21||||0.462|2-Sided|95.0|-0.36|0.78||a priori threshold for significance <0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.|
1635052|NCT02019108|3003609|Superiority||Mean Difference (Final Values)|-2.7||||0.232|2-Sided|95.0|-7.3|1.8||a priori threshold for statistical significance <0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.|
1635053|NCT02019108|3003609|Superiority||Mean Difference (Final Values)|-3.7||||0.111|2-Sided|95.0|-8.3|0.9||a priori threshold for statistical significance <0.05.|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.|
1635054|NCT02019108|3003610|Superiority||Mean Difference (Final Values)|-6.78|||<|0.001|2-Sided|95.0|-8.82|-4.75||a priori threshold for statistical significance <0.05.|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.|
1635055|NCT02019108|3003610|Superiority||Mean Difference (Final Values)|-9.04|||<|0.001|2-Sided|95.0|-11.22|-6.86||a priori threshold for statistical significance <0.05.|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.|
1635056|NCT02019108|3003611|Superiority||Mean Difference (Final Values)|-0.06||||0.058|2-Sided|95.0|-0.12|0.0||a priori threshold for statistical significance <0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.|
1635057|NCT02019108|3003611|Superiority||Mean Difference (Final Values)|-0.06||||0.031|2-Sided|95.0|-0.11|-0.01||a priori threshold for statistical significance <0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.|
1635058|NCT02019108|3003612|Superiority||Mean Difference (Final Values)|-0.2||||0.056|2-Sided|95.0|-0.4|0.01||a priori threshold for statistical significance <0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.|
1635059|NCT02019108|3003612|Superiority||Mean Difference (Final Values)|-0.26|||<|0.001|2-Sided|95.0|-0.39|-0.12||a priori threshold for statistical significance <0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.|
1635060|NCT02019108|3003613|Superiority||Mean Difference (Final Values)|-0.17||||0.103|2-Sided|95.0|-0.37|0.03||a priori threshold for statistical significance <0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks|
1635061|NCT02019108|3003613|Superiority||Median Difference (Final Values)|-0.14||||0.125|2-Sided|95.0|-0.31|0.04||a priori threshold for statistical significance <0.05|ANCOVA|Controlling for baseline values and walking speed.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks|
1635062|NCT02019108|3003614|Superiority||Mean Difference (Final Values)|-1.1||||0.133|2-Sided|95.0|-2.5|0.3||a priori threshold for statistical significance <0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.|
1635063|NCT02019108|3003614|Superiority||Mean Difference (Final Values)|-1.1||||0.117|2-Sided|95.0|-2.6|0.3||a priori threshold for statistical significance <0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.|
1635064|NCT02019108|3003615|Superiority||Mean Difference (Final Values)|-0.8||||0.079|2-Sided|95.0|-1.6|0.1||a priori threshold for statistical significance <0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 21 weeks.|
1635065|NCT02019108|3003615|Superiority||Mean Difference (Final Values)|-0.3||||0.495|2-Sided|95.0|-1.1|0.5||a priori threshold for statistical significance <0.05|ANCOVA|Controlling for baseline values.||This is the comparison between Gait Modification Group and Walking Only Group at 17 weeks.|
1635066|NCT02018822|3003630|Non-Inferiority|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2707|||||||Chi-squared||||
1635067|NCT02018822|3003631|Non-Inferiority|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3883|||||||Chi-squared||||
1635068|NCT02018822|3003632|Non-Inferiority|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3883|||||||Chi-squared||||
1635240|NCT02014467|3004112|Superiority or Other||Mean Difference (Net)|4.42|||<|0.0001|2-Sided|95.0|3.67|5.18|||ANCOVA||||
1635069|NCT02018822|3003633|Non-Inferiority|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.3891|||||||Chi-squared||||
1635070|NCT02018822|3003634|Non-Inferiority|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2235|||||||Chi-squared||||
1635071|NCT02018822|3003635|Non-Inferiority|Assuming that the success rate of the control composite resin is 95% based on clinical data, for a non-inferiority test with a non-inferiority margin of 15%, a sample size of 27 is required in each group to allow 80% power at an alpha level of 0.05. We aimed to have 30 subjects/teeth remaining in each group after attrition at the end of the study.||||||0.2552|||||||Chi-squared||||
1635072|NCT02017327|3003701|Superiority|||||||0.0045|||||||Cochran-Mantel-Haenszel||||
1635073|NCT02017327|3003701|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1635074|NCT02016898|3003732|Other||Median Difference (Final Values)|0.2|Standard Deviation|2.01||0.539|2-Sided||||||t-test, 1 sided||||
1635075|NCT02016898|3003733|Other||Risk Ratio (RR)|0.93||||0.7|2-Sided|95.0|0.67|1.29|||Chi-squared||||
1635076|NCT02016716|3003744|Non-Inferiority|Non-inferiority was claimed if the lower bound of the 1-sided 97.5% CI (or the lower bound of 2-sided 95% CI) of the mean difference between the 2 romosozumab groups was > -2.0%.|Least Squares Mean Difference|-0.4|||||2-Sided|95.0|-1.5|0.7|||||Based on ANCOVA model adjusting for treatment, and baseline lumbar spine BMD T-score.|The primary hypothesis was that the mean percent change from baseline in lumbar spine BMD at month 6 in participants receiving romosozumab 210 mg QM using the 90 mg/mL concentration would not be inferior to that in participants receiving romosozumab 210 mg QM using the 70 mg/mL concentration.|
1635077|NCT02016625|3003753|Non-Inferiority or Equivalence|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|96.16|Standard Error of the Mean|12.9||0.0008|2-Sided|90.0|88.53|104.45|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.|
1635078|NCT02016625|3003754|Non-Inferiority or Equivalence|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|99.54|Standard Error of the Mean|10.0||0|2-Sided|90.0|93.375|106.115|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.|
1635079|NCT02016625|3003755|Non-Inferiority or Equivalence|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|93.85|Standard Error of the Mean|25.1||0.0493|2-Sided|90.0|80.059|110.022|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.|
1635080|NCT02016625|3003756|Non-Inferiority or Equivalence|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|99.15|Standard Error of the Mean|28.5||0.0269|2-Sided|90.0|82.857|118.644|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.|
1635081|NCT02016625|3003757|Non-Inferiority or Equivalence|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|136.85|Standard Error of the Mean|22.4||0.8592|2-Sided|90.0|118.683|157.793|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.|
1635082|NCT02016625|3003758|Non-Inferiority or Equivalence|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|127.41|Standard Error of the Mean|16.8||0.6207|2-Sided|90.0|114.453|141.827|||ANOVA||gMean ratio of tac+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of tac+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.|
1635083|NCT02016625|3003759|Non-Inferiority or Equivalence|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|122.68|Standard Error of the Mean|23.9||0.4181|2-Sided|90.0|104.8|143.6|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.|
1635084|NCT02016625|3003760|Non-Inferiority or Equivalence|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|116.92|Standard Error of the Mean|11.0||0.065|2-Sided|90.0|108.674|125.801|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.|
1635085|NCT02016625|3003761|Non-Inferiority or Equivalence|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|140.98|Standard Error of the Mean|35.8||0.8122|2-Sided|90.0|111.772|177.833|||ANOVA||gMean ratio of cyclo+FDV to FDV treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to FDV treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.|
1635086|NCT02016625|3003762|Non-Inferiority or Equivalence|H0: ratio is outside of interval (80%, 125%) VS H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|90.14|Standard Error of the Mean|16.6||0.0457|2-Sided|90.0|80.281|101.205|||ANOVA||gMean ratio of cyclo+FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to cyclo treatment The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.|
1635087|NCT02016625|3003763|Non-Inferiority or Equivalence|H0: ratio is outside of interval (80%, 125%) vs. H1: ratio is inside of interval (80%, 125%)|gMean ratio (%)|106.6|Standard Error of the Mean|11.7||0.0019|2-Sided|90.0|98.36|115.534|||ANOVA||gMean ratio of cyclo+FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|gMean ratio of cyclo+FDV to cyclo treatment The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.|
1635088|NCT02016625|3003764|Non-Inferiority or Equivalence|Null hypothesis (H0): ratio is outside of interval (80%, 125%) vs. alternative hypothesis (H1): ratio is inside of interval (80%, 125%)|gMean ratio (%)|108.2|Standard Error of the Mean|11.5||0.0033|2-Sided|90.0|99.992|117.076|||ANOVA||ratio of cyclo + FDV to cyclo treatment. The standard error of the mean actually is the geometric coefficient of variation (%).|Geometric mean (gMean) ratio of cyclo + FDV to cyclo treatment. The statistical model used for the analysis of primary endpoints was an analysis of variance (ANOVA) model on the logarithmic scale. This model accounted for variation from 'subject' and 'treatment' effects. The 'subject' effect was considered to be random, whereas the 'treatment' effect was considered as fixed.|
1635089|NCT02016482|3003767|Superiority or Other||LS Mean Difference|-2.8|||<|0.001|2-Sided|95.0|-3.4|-2.1||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635090|NCT02016482|3003768|Superiority or Other||Difference in percentage|2.5||||0.164|2-Sided|95.0|-0.9|6.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Chi-squared||||
1635091|NCT02016482|3003769|Superiority or Other||LS Mean Difference|-1.3||||0.005|2-Sided|95.0|-2.3|-0.4||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||HADS depression score|
1635092|NCT02016482|3003769|Superiority or Other||LS Mean Difference|-1.1||||0.025|2-Sided|95.0|-2.0|-0.1||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||HADS anxiety score|
1635093|NCT02016482|3003770|Superiority or Other||LS Mean Difference|5.5||||0.012|2-Sided|95.0|1.2|9.8||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635094|NCT02016482|3003771|Superiority or Other||LS Mean Difference|0.1|||<|0.001|2-Sided|95.0|0.1|0.2||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635095|NCT02016482|3003772|Superiority or Other||LS Mean Difference|-21.4|||<|0.001|2-Sided|95.0|-27.3|-15.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Activity impairment|
1635096|NCT02016482|3003772|Superiority or Other||LS Mean Difference|-15.2|||<|0.001|2-Sided|95.0|-21.0|-9.3||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Overall work impairment|
1635097|NCT02016482|3003772|Superiority or Other||LS Mean Difference|-17.3|||<|0.001|2-Sided|95.0|-22.9|-11.6||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Presenteeism|
1635098|NCT02016482|3003772|Superiority or Other||LS Mean Difference|0.7|||<|0.416|2-Sided|95.0|-1.0|2.5||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Absenteeism|
1635099|NCT02016482|3003773|Superiority or Other||Difference in percentage|27.1|||<|0.001|2-Sided|95.0|16.7|37.4||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel|||DLQI = 0/1|
1635100|NCT02016482|3003773|Superiority or Other||Difference in percentage|15.7|||<|0.001|2-Sided|95.0|7.1|24.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel|||DLQI = 0|
1635101|NCT02016482|3003774|Superiority or Other||LS Mean Difference|-6.1|||<|0.001|2-Sided|95.0|-7.8|-4.5||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635103|NCT02016482|3003776|Superiority or Other||LS Mean Difference|-0.9|||<|0.001|2-Sided|95.0|-1.1|-0.7||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635104|NCT02016482|3003777|Superiority or Other||LS Mean Difference|-57.7|||<|0.001|2-Sided|95.0|-73.1|-42.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635105|NCT02016482|3003778|Superiority or Other||LS Mean Difference|-50.9|||<|0.001|2-Sided|95.0|-64.0|-37.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635106|NCT02016482|3003779|Superiority or Other||LS Mean Difference|-80.6|||<|0.001|2-Sided|95.0|-97.9|-63.3||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635107|NCT02016482|3003780|Superiority or Other||LS Mean Difference|-11.1|||<|0.001|2-Sided|95.0|-13.9|-8.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635108|NCT02016482|3003781|Superiority or Other||Difference in percentage|90.4|||<|0.001|2-Sided|95.0|72.5|108.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel||||
1635109|NCT02016482|3003782|Superiority or Other||Difference in percentage|24.8|||<|0.001|2-Sided|95.0|15.3|34.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel||||
1635110|NCT02016482|3003783|Superiority or Other||Difference in percentage|52.2|||<|0.001|2-Sided|95.0|40.8|63.7||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel||||
1635111|NCT02016482|3003784|Superiority or Other||Difference in percentage|26.4|||<|0.001|2-Sided|95.0|15.8|36.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel|||PASI 100|
1635112|NCT02016482|3003784|Superiority or Other||Difference in percentage|40.9|||<|0.001|2-Sided|95.0|29.0|52.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel|||PASI 90|
1635113|NCT02016482|3003784|Superiority or Other||Difference in percentage|52.5|||<|0.001|2-Sided|95.0|39.9|65.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel|||PASI 50|
1635114|NCT02016482|3003784|Superiority or Other||Difference in percentage|51.1|||<|0.001|2-Sided|95.0|38.6|63.5||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel|||PASI 75|
1635115|NCT02016482|3003785|Superiority or Other||LS Mean Difference|-71.2|||<|0.001|2-Sided|95.0|-87.3|-55.0||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635116|NCT02016482|3003786|Superiority or Other||LS Mean Difference|-8.1|||<|0.001|2-Sided|95.0|-10.0|-6.1||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635117|NCT02016482|3003787|Superiority or Other||LS Mean Difference|-19.5|||<|0.001|2-Sided|95.0|-23.6|-15.3||Across all strata, P values were calculated from ANCOVA with stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635118|NCT02016482|3003788|Superiority or Other||LS Mean Difference|-40.2|||<|0.001|2-Sided|95.0|-50.0|-30.4||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635119|NCT02016482|3003789|Superiority or Other||LS Mean Difference|-2.5|||<|0.001|2-Sided|95.0|-3.1|-1.9||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635120|NCT02016482|3003790|Superiority or Other||Difference in percentage|18.5|||<|0.001|2-Sided|95.0|10.1|26.8||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel||||
1635121|NCT02016482|3003791|Superiority or Other||Difference in percentage|7.4||||0.004|2-Sided|95.0|2.4|12.4||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel||||
1635122|NCT02016482|3003792|Superiority or Other||LS Mean Difference|-50.1|||<|0.001|2-Sided|95.0|-58.3|-41.9||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635123|NCT02016482|3003793|Superiority or Other||LS Mean Difference|-28.6|||<|0.001|2-Sided|95.0|-33.5|-23.7||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635124|NCT02016482|3003794|Superiority or Other||LS Mean Difference|-38.9|||<|0.001|2-Sided|95.0|-46.9|-30.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635125|NCT02016482|3003795|Superiority or Other||LS Mean Difference|-3.5|||<|0.001|2-Sided|95.0|-4.3|-2.8||Across all strata, P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA||||
1635126|NCT02016482|3003796|Superiority or Other||Difference in percentage|13.3|||<|0.001|2-Sided|95.0|6.5|20.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel||||
1635127|NCT02016482|3003797|Superiority or Other||Difference in percentage|36.0|||<|0.001|2-Sided|95.0|25.0|46.9||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel||||
1635128|NCT02016482|3003798|Superiority or Other||Difference in percentage|18.6|||<|0.001|2-Sided|95.0|10.6|26.6||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel||||
1635129|NCT02016482|3003799|Superiority or Other||Difference in percentage|44.8|||<|0.001|2-Sided|95.0|33.2|56.5||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel||||
1635130|NCT02016482|3003800|Superiority or Other||Difference in percentage|43.3|||<|0.001|2-Sided|95.0|31.3|55.2||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel||||
1635131|NCT02016482|3003801|Superiority or Other||Difference in percentage|57.9||||0.002|2-Sided|95.0|33.8|82.0||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel|||Ranked fifth secondary endpoint. For US regulatory purposes, ranked sixth secondary endpoint.|
1635132|NCT02016482|3003802|Superiority or Other||LS Mean Difference|-2.9|||<|0.001|2-Sided|95.0|-3.6|-2.2||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked fourth secondary endpoint. For US regulatory purposes, ranked fifth secondary endpoint.|
1635133|NCT02016482|3003803|Superiority or Other||LS Mean Percent Change|-2.6|||<|0.001|2-Sided|95.0|-3.3|-2.0||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked third secondary endpoint. For US regulatory purposes, ranked fourth secondary endpoint.|
1635134|NCT02016482|3003804|Superiority or Other||Difference in percentage|6.6||||0.008|2-Sided|95.0|1.8|11.3||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel|||Ranked second secondary endpoint. For US regulatory purposes, ranked third secondary endpoint.|
1635135|NCT02016482|3003805|Superiority or Other||LS Mean|-44.8|||<|0.001|2-Sided|95.0|-53.5|-36.0||P values were calculated from ANCOVA with treatment center stratum, Baseline value, and treatment in the model.|ANCOVA|||Ranked first secondary endpoint. For US regulatory purposes, ranked second secondary endpoint.|
1635136|NCT02016482|3003806|Superiority or Other||Difference in percentage|42.0|||<|0.001|2-Sided|95.0|30.8|53.2||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel|||Ranked sixth secondary endpoint. For US regulatory purposes, this was the primary endpoint.|
1635137|NCT02016482|3003807|Superiority or Other||Difference in percentage|43.2|||<|0.001|2-Sided|95.0|32.8|53.6||Cochran-Mantel-Haenszel test adjusted for strata. If zero frequency occurred, strata were dropped and p-value was calculated based on chi-square test (or adjusted chi-square test based on Campbell [2007]).|Cochran-Mantel-Haenszel|||For US regulatory purposes, ranked first secondary endpoint.|
1635138|NCT02016300|3003808|Other|||||||0.091|||||||Regression, Linear|||Difference between baseline and month 24.|
1635139|NCT02016300|3003808|Other|||||||0.02|||||||Regression, Linear|||Difference between baseline and month 12.|
1635140|NCT02016300|3003809|Other|||||||0.276|||||||Regression, Linear|||Difference between baseline and month 24.|
1635141|NCT02016300|3003809|Other|||||||0.064|||||||Regression, Linear|||Difference between baseline and month 12.|
1635142|NCT02016300|3003810|Other|||||||0.414|||||||Regression, Linear|||Difference between baseline and month 24.|
1635143|NCT02016300|3003810|Other|||||||0.774|||||||Regression, Linear|||Difference between baseline and month 12.|
1635144|NCT02016300|3003811|Other|||||||0.854|||||||Regression, Linear|||Difference between baseline and month 24.|
1635145|NCT02016300|3003811|Other|||||||0.666|||||||Regression, Linear|||Difference between baseline and month 12.|
1635146|NCT02016300|3003811|Other|||||||0.733|||||||Regression, Linear|||Difference between baseline and month 6.|
1635147|NCT02016300|3003812|Other|||||||0.634|||||||Regression, Linear|||Difference between baseline and month 24.|
1635148|NCT02016300|3003812|Other|||||||0.958|||||||Regression, Linear|||Difference between baseline and month 12.|
1635149|NCT02016300|3003812|Other|||||||0.729|||||||Regression, Linear|||Difference between baseline and month 6.|
1635150|NCT02016300|3003813|Other|||||||0.179|||||||Regression, Linear|||Difference between baseline and month 24.|
1635151|NCT02016300|3003813|Other|||||||0.34|||||||Regression, Linear|||Difference between baseline and month 12.|
1635152|NCT02016300|3003813|Other|||||||0.387|||||||Regression, Linear|||Difference between baseline and month 6.|
1635153|NCT02016300|3003814|Other|||||||0.043|||||||Regression, Linear|||Difference between baseline and month 24.|
1635154|NCT02016300|3003814|Other|||||||0.094|||||||Regression, Linear|||Difference between baseline and month 12.|
1635155|NCT02016300|3003814|Other|||||||0.162|||||||Regression, Linear|||Difference between baseline and month 6.|
1635156|NCT02016170|3003820|Non-Inferiority or Equivalence|Non-inferiority was assessed using a 95% confidence interval (CI) of the difference in mean PRU between prasugrel and ticagrelor (two arms combined).|Mean Difference (Final Values)|-11.0|||||2-Sided|95.0|-18.0|-4.0|||||||
1635157|NCT02016170|3003821|Non-Inferiority or Equivalence|Non-inferiority was assessed using a 95% confidence interval (CI) of the difference in mean PRU between prasugrel and ticagrelor (two arms combined). Under the assumption of 0 difference in mean PRU between ticagrelor 90 mg bid MD and prasugrel 10 mg qd MD and a common standard deviation of 60 PRU, a sample size of 24 patients per group allowed for the 95% CI to stay within ± 45 PRU with a 90% power and alpha=0.05.|Mean Difference (Final Values)|-18.0|||||2-Sided|95.0|-41.0|5.0|||||||
1635158|NCT02016105|3003833|Equivalence|LSM, SE and 95% CI were estimated using an ANCOVA model with treatment, body weight strata, region and prior systemic therapy as fixed effects and baseline PASI score as covariate. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira was contained within the interval [−15%; 15%].|LS means difference|1.2|Standard Error of the Mean|2.0|||2-Sided|95.0|-2.78|5.08|||||||
1635159|NCT02016105|3003834|Equivalence|"LS means, SE and 95% CI were estimated by a Mixed Model Repeated Measures (MMRM) model with treatment, visit, treatment-by-visit interaction, body weight strata, region and prior systemic therapy, as fixed factors and baseline PASI score as covariate.~Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2017 and Humira treatment was contained within the interval [-15%; 15%]."|LS means difference|0.8|Standard Error of the Mean|2.03|||2-Sided|95.0|-3.15|4.84|||||||
1635160|NCT02016105|3003835|Equivalence|Adjusted response rates were estimated using a logistic regression model including treatment, body weight strata, region and prior systemic therapy. The 95% CI for the rate difference was derived based on the normal approximation and standard error computed using the delta method.To conclude equivalent efficacy, the 95% CI had to be entirely within the interval [-18%, 18%].|Risk Difference (RD)|1.8|Standard Error of the Mean|4.75|||2-Sided|95.0|-7.46|11.15|||||||
1635161|NCT02015754|3003848|Other|VEGFR2 at 24 hours post treatment.||||||0.2163|||||||one-sample Wilcoxon signed rank test||||
1635162|NCT02015754|3003848|Other|VEGFR2 immediately post treatment.||||||0.1353|||||||one-sample Wilcoxon signed rank test||||
1635163|NCT02015754|3003848|Other|VEGFR1 at 24 hours post treatment.||||||0.0012|||||||one-sample Wilcoxon signed rank test||||
1635164|NCT02015754|3003848|Other|VEGFR1 immediately post treatment.||||||0.583|||||||one-sample Wilcoxon signed rank test||||
1635165|NCT02015754|3003848|Other|VEGF at 24 hours post treatment.||||||0.4143|||||||one-sample Wilcoxon signed rank test||||
1635166|NCT02015754|3003848|Other|VEGF immediately post treatment||||||0.6257|||||||one-sample Wilcoxon signed rank test||||
1635167|NCT02015754|3003855|Other|||||||0.004||||||Differences of p-value < 0.05 considered statistically significant.|Regression, Cox|||Multivariate Cox-regression analysis to identify independent prognostic factors for overall survival from baseline characteristics. Relative risk with 95% confidence intervals calculated as measure of association.|
1635168|NCT02015637|3003885|Non-Inferiority|Two-sided 95% confidence intervals (CIs) using the Wald test was constructed for comparisons between delafloxacin and ceftriaxone. A hierarchical approach was implemented for the primary and secondary analyses to control for the overall type 1 error rate of 0.05 due to multiple comparisons.|Difference in cure rates|-9.9|||||2-Sided|95.0|-16.03|-3.87|||||||
1635169|NCT02015637|3003886|Non-Inferiority|Two-sided 95% confidence intervals (CIs) using the Wald test was constructed for comparisons between delafloxacin and ceftriaxone. A hierarchical approach was implemented for the primary and secondary analyses to control for the overall type 1 error rate of 0.05 due to multiple comparisons.|Difference in cure rate|-5.9|||||2-Sided|95.0|-13.18|1.36|||||||
1635170|NCT02015442|3003900|Superiority|||||||0.244|||||||ANOVA||||
1635171|NCT02015442|3003900|Superiority|||||||0.244|||||||t-test, 2 sided|||Baseline vs treatment|
1635172|NCT02015442|3003900|Superiority|||||||0.001||||||calculated|t-test, 2 sided|||Baseline vs treatment|
1635173|NCT02015442|3003901|Superiority|||||||0.204|||||||t-test, 2 sided|||Baseline vs treatment|
1635174|NCT02015442|3003901|Superiority|||||||0.39|||||||t-test, 2 sided|||Baseline vs. treatment period|
1635175|NCT02014584|3003930|Superiority or Other||Adjusted mean difference|-0.5|Standard Error of the Mean|0.76||0.5|2-Sided|95.0|-2.0|1.0|||t-test from general linear model||DB Week 24||
1635176|NCT02014584|3003930|Superiority or Other||Adjusted mean difference|-0.6|Standard Error of the Mean|0.51||0.22|2-Sided|95.0|-1.7|0.4|||t-test from general linear model||DB Week 12||
1635177|NCT02014584|3003932|Superiority or Other||Adjusted mean difference|3.3|Standard Error of the Mean|1.14||0.004|2-Sided|95.0|1.1|5.6|||t-test from general linear model||DB Week 24||
1635178|NCT02014584|3003932|Superiority or Other||Adjusted mean difference|1.1|Standard Error of the Mean|1.14||0.33|2-Sided|95.0|-1.1|3.4|||t-test from general linear model||DB Week 12||
1635179|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|-0.1|Standard Error of the Mean|0.22||0.69|2-Sided|95.0|-0.5|0.3|||t-test from general linear model||Overall sexual satisfaction DB Week 24||
1635180|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|-0.1|Standard Error of the Mean|0.2||0.64|2-Sided|95.0|-0.5|0.3|||t-test from general linear model||Overall sexual satisfaction DB Week 12||
1635181|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|0.2|Standard Error of the Mean|0.17||0.28|2-Sided|95.0|-0.2|0.5|||t-test from general linear model||Overall sexual satisfaction DB Week 4||
1635182|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|0.0|Standard Error of the Mean|0.27||1|2-Sided|95.0|-0.5|0.5|||t-test from general linear model||Sexual desire DB Week 24||
1635183|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|-0.2|Standard Error of the Mean|0.22||0.28|2-Sided|95.0|-0.7|0.2|||t-test from general linear model||Sexual desire DB Week 12||
1635184|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|0.3|Standard Error of the Mean|0.21||0.19|2-Sided|95.0|-0.1|0.7|||t-test from general linear model||Sexual desire DB Week 4||
1635185|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|-0.1|Standard Error of the Mean|0.23||0.64|2-Sided|95.0|-0.6|0.3|||t-test from general linear model||Orgasmic function DB Week 24||
1635186|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|-0.2|Standard Error of the Mean|0.15||0.33|2-Sided|95.0|-0.5|0.2|||t-test from general linear model||Orgasmic function DB Week 12||
1635187|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|0.2|Standard Error of the Mean|0.16||0.23|2-Sided|95.0|-0.1|0.5|||t-test from general linear model||Orgasmic function DB Week 4||
1635188|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|-0.2|Standard Error of the Mean|0.34||0.64|2-Sided|95.0|-0.8|0.5|||t-test from general linear model||Intercourse satisfaction DB Week 24||
1635241|NCT02014376|3004156|Superiority||||||=|0|||||||Fisher Exact||||
1635189|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|-0.1|Standard Error of the Mean|0.33||0.73|2-Sided|95.0|-0.8|0.5|||t-test from general linear model||Intercourse satisfaction DB Week 12||
1635190|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|0.3|Standard Error of the Mean|0.23||0.13|2-Sided|95.0|-0.1|0.8|||t-test from general linear model||Intercourse satisfaction DB Week 4||
1635191|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|-0.7|Standard Error of the Mean|0.61||0.27|2-Sided|95.0|-1.9|0.5|||t-test from general linear model||Erectile Function DB Week 24||
1635192|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|-0.8|Standard Error of the Mean|0.52||0.14|2-Sided|95.0|-1.8|0.3|||t-test from general linear model||Erectile Function DB Week 12||
1635193|NCT02014584|3003934|Superiority or Other||Adjusted mean difference|0.2|Standard Error of the Mean|0.33||0.46|2-Sided|95.0|-0.4|0.9|||t-test from general linear model||Erectile Function DB Week 4||
1635194|NCT02014584|3003936|Superiority or Other||Adjusted mean difference|0.0|Standard Error of the Mean|1.04||0.99|2-Sided|95.0|-2.0|2.1|||t-test from general linear model||DB Week 24||
1635195|NCT02014584|3003936|Superiority or Other||Adjusted mean difference|-1.3|Standard Error of the Mean|1.09||0.25|2-Sided|95.0|-3.4|0.9|||t-test from general linear model||DB Week 12||
1635196|NCT02014584|3003936|Superiority or Other||Adjusted mean difference|1.4|Standard Error of the Mean|0.8||0.082|2-Sided|95.0|-0.2|3.0|||t-test from general linear model||DB Week 4||
1635197|NCT02014584|3003938|Superiority or Other||Median Difference (Final Values)|6.3||||0.31|2-Sided|95.0|-4.2|16.7|||Fisher’s Exact Test||DB Week 24||
1635198|NCT02014584|3003938|Superiority or Other||Median Difference (Final Values)|6.4||||0.34|2-Sided|95.0|-4.7|17.6|||Fisher’s Exact Test||DB Week 12||
1635199|NCT02014584|3003938|Superiority or Other||Median Difference (Final Values)|-3.5||||0.62|2-Sided|95.0|-10.4|3.4|||Fisher’s Exact Test||DB Week 4||
1635200|NCT02014584|3003984|Superiority or Other||Mean Difference (Final Values)|7.0||||0.27|2-Sided|95.0|-4.7|18.8|||Fisher’s Exact Test||||
1635201|NCT02014558|3003985|Other||Geometric LS Mean Ratio|82.84|||||2-Sided|90.0|40.25|170.48||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.|
1635202|NCT02014558|3003987|Other||Geometric LS Mean Ratio|83.93|||||2-Sided|90.0|46.53|151.39||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.|
1635203|NCT02014558|3003989|Other||Geometric LS Mean Ratio|106.42|||||2-Sided|90.0|85.28|132.81||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.|
1635204|NCT02014558|3003992|Other||Geometric LS Mean Ratio|97.71|||||2-Sided|90.0|74.19|128.7||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.|
1635205|NCT02014558|3003993|Other||Geometric LS Mean Ratio|91.46|||||2-Sided|90.0|74.6|112.12||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.|
1635206|NCT02014558|3003994|Other||Geometric LS Mean Ratio|93.96|||||2-Sided|90.0|75.29|117.26||||||Statistical Assessment of the Effect of Gilteritinib on Cephalexin Pharmacokinetics after Administration of Cephalexin Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between cephalexin alone and cephalexin + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.|
1635207|NCT02014558|3003999|Other||Geometric LS Mean Ratio|123.47|||||2-Sided|90.0|72.41|210.52||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between 1-hydroxymidazolam/midazolam alone and 1-hydroxymidazolam/midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.|
1635208|NCT02014558|3004000|Other||Geometric LS Mean Ratio|111.64|||||2-Sided|90.0|69.54|179.25||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.|
1635209|NCT02014558|3004001|Other||Geometric LS Mean Ratio|149.9||||||90.0|74.88|300.06||||||"Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of LS means of log-transformed pharmacokinetic parameters between~1-hydroxymidazolam alone and 1-hydroxymidazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent."|
1635210|NCT02014558|3004002|Other||Geometric LS Mean Ratio|109.46|||||2-Sided|90.0|49.82|240.48||||||Statistical Comparison of Midazolam Exposure after Administration of Midazolam Alone or Coadministered with Gilteritinib: The difference of least squares (LS) means of log-transformed pharmacokinetic parameters between midazolam alone and midazolam + gilteritinib and its 90% CI are backtransformed to the raw scale and are expressed as percent.|
1635211|NCT02014558|3004040|Other||Slope|1.21|||||2-Sided|90.0|1.02|1.41||||||Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.|
1635212|NCT02014558|3004040|Other||Slope|0.808|||||2-Sided|90.0|0.629|0.988||||||Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.|
1635213|NCT02014558|3004041|Other||Slope|1.22|||||2-Sided|90.0|1.0|1.43||||||Dose Proportionality (Multiple Dose / Cycle 1 Day 15) was evaluated using the power model.|
1635214|NCT02014558|3004041|Other||Slope|0.99|||||2-Sided|90.0|0.788|1.19||||||Dose Proportionality (Single Dose / Day -2) was evaluated using the power model.|
1635215|NCT02014480|3004084|Superiority or Other||Mean Difference (Final Values)|0.057||||0.008|2-Sided|95.0|0.015|0.099||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of >=12% and 200 mL at any assessment(s).||
1635216|NCT02014480|3004084|Superiority or Other||Mean Difference (Final Values)|0.078|||<|0.001|2-Sided|95.0|0.036|0.12||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of >=12% and 200 mL at any assessment(s).||
1635217|NCT02014480|3004084|Superiority or Other||Mean Difference (Final Values)|0.082|||<|0.001|2-Sided|95.0|0.04|0.125||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of >=12% and 200 mL at >=1 time point over 0-6 hours post-dose in FEV1 on Day 1.||
1635218|NCT02014480|3004084|Superiority or Other||Mean Difference (Final Values)|0.129|||<|0.001|2-Sided|95.0|0.086|0.171||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of >=12% and 200 mL at >=1 time point over 0-6 hours post-dose in FEV1 on Day 1.||
1635219|NCT02014480|3004084|Superiority or Other||Mean Difference (Final Values)|0.107|||<|0.001|2-Sided|95.0|0.064|0.149||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of >=12% and 200 mL at >=1 time point over 0-6 hours post-dose in FEV1 on Day 1.||
1635220|NCT02014480|3004084|Superiority or Other||Mean Difference (Final Values)|0.108|||<|0.001|2-Sided|95.0|0.065|0.151||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of >=12% and 200 milliliters (mL) at >=1 time point over 0-6 hours post-dose in FEV1 on Day 1.||
1635221|NCT02014467|3004103|Superiority or Other||Hodges Lehmann Estimate of Difference|-51.21|||<|0.0001|2-Sided|95.0|-56.26|-45.91||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-PINP at Month 12||
1635222|NCT02014467|3004103|Superiority or Other||Hodges Lehmann Estimate of Difference|-56.94|||<|0.0001|2-Sided|95.0|-61.6|-52.7||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-PINP at Month 6||
1635223|NCT02014467|3004104|Superiority or Other||Hodges Lehmann Estimate of Difference|-52.56|||<|0.0001||95.0|-59.38|-46.17||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-CTX at Month 12||
1635224|NCT02014467|3004104|Superiority or Other||Hodges Lehmann Estimate of Difference|-56.92|||<|0.0001|2-Sided|95.0|-61.38|-52.65||Two-Sided, Wilcoxon t Approximation|Wilcoxon Rank Sum test||s-CTX at Month 6||
1635225|NCT02014467|3004105|Superiority or Other|||||||0.3957||||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA||||
1635226|NCT02014467|3004105|Superiority or Other||Mean Difference (Net)|4.72|||<|0.0001|2-Sided|95.0|3.71|5.72|||ANCOVA||||
1635227|NCT02014467|3004106|Superiority or Other|||||||0.541||||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA||||
1635228|NCT02014467|3004106|Superiority or Other||Mean Difference (Net)|2.62|||<|0.0001|2-Sided|95.0|1.96|3.27|||ANCOVA||||
1635229|NCT02014467|3004107|Superiority or Other|||||||0.3513||||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA||||
1635230|NCT02014467|3004107|Superiority or Other||Mean Difference (Net)|3.31|||<|0.0001|2-Sided|95.0|2.74|3.88|||ANCOVA||||
1635231|NCT02014467|3004108|Superiority or Other|||||||0.6082||||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA||||
1635232|NCT02014467|3004108|Superiority or Other||Mean Difference (Net)|3.36|||<|0.0001||95.0|2.39|4.32|||ANCOVA||||
1635233|NCT02014467|3004109|Superiority or Other|||||||0.4369||||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA||||
1635234|NCT02014467|3004109|Superiority or Other||Mean Difference (Net)|1.59|||<|0.0001|2-Sided|95.0|0.98|2.2|||ANCOVA||||
1635235|NCT02014467|3004110|Superiority or Other|||||||0.107||||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA||||
1635236|NCT02014467|3004110|Superiority or Other||Mean Difference (Net)|2.26|||<|0.0001|2-Sided|95.0|1.72|2.8|||ANCOVA||||
1635237|NCT02014467|3004111|Superiority or Other|||||||0.9029||||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA||||
1635238|NCT02014467|3004111|Superiority or Other||Mean Difference (Net)|3.21|||<|0.0001|2-Sided|95.0|2.45|3.96|||ANCOVA||||
1635239|NCT02014467|3004112|Superiority or Other|||||||0.7495||||||Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region|ANCOVA||||
1635383|NCT02008526|3004630|Superiority||F|1.16||||0.3137|2-Sided||||||ANOVA|2 Degrees of Freedom|||
1635242|NCT02014272|3004162|Superiority or Other||Ratio of adjusted geometric means|102.41|||||2-Sided|90.0|98.76|106.19||||||Natural log transformed AUC(0 - ∞) of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.|
1635243|NCT02014272|3004162|Superiority or Other||Ratio of adjusted geometric means|95.92|||||2-Sided|90.0|92.54|99.43||||||Natural log transformed AUC(0 - ∞) of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.|
1635244|NCT02014272|3004163|Superiority or Other||Ratio of adjusted geometric means|107.58|||||2-Sided|90.0|96.07|120.47||||||Natural log transformed Cmax of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.|
1635245|NCT02014272|3004163|Superiority or Other||Ratio of adjusted geometric means|91.63|||||2-Sided|90.0|83.13|101.01||||||Natural log transformed Cmax of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.|
1635246|NCT02014272|3004164|Superiority or Other||Ratio of adjusted geometric means|103.45|||||2-Sided|90.0|99.33|107.75||||||Natural log transformed AUClast of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.|
1635247|NCT02014272|3004164|Superiority or Other||Ratio of adjusted geometric means|95.45|||||2-Sided|90.0|92.07|98.94||||||Natural log transformed AUClast of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.|
1635248|NCT02013687|3004202|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)||||
1635249|NCT02013687|3004202|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1635250|NCT02013687|3004203|Superiority or Other|||||||0.6|||||||Wilcoxon (Mann-Whitney)||||
1635251|NCT02013687|3004203|Superiority or Other|||||||0.8|||||||Wilcoxon (Mann-Whitney)||||
1635252|NCT02013687|3004204|Superiority or Other||||||<|0.001||||||Significance of IgG values at study day 196 as compared to day 0 (pre-immune).|Wilcoxon (Mann-Whitney)||||
1635253|NCT02013687|3004204|Superiority or Other||||||<|0.001||||||Significance of IgG values at study day 196 as compared to day 0 (pre-immune).|Wilcoxon (Mann-Whitney)||||
1635254|NCT02013622|3004231|Superiority or Other|||||||0.0306|||||||t-test, 2 sided|||Statistical analysis at Week 16|
1635255|NCT02013622|3004233|Superiority or Other|||||||0.9812|||||||t-test, 2 sided|||Statistical analysis at Week 16 in AUC for money|
1635256|NCT02013622|3004233|Superiority or Other|||||||0.6648|||||||t-test, 2 sided|||Statistical analysis at Week 16 in AUC for food|
1635257|NCT02013622|3004234|Superiority or Other|||||||0.1815|||||||t-test, 2 sided|||Statistical analysis at Week 16 in DRT|
1635258|NCT02013622|3004235|Superiority or Other|||||||0.9416|||||||t-test, 2 sided|||Statistical analysis at Week 16 in DPDT for Probability Discounting Task h value|
1635259|NCT02013622|3004235|Superiority or Other|||||||0.2923|||||||t-test, 2 sided|||Statistical analysis at Week 16 in DPDT for Delay Discounting Task k value|
1635260|NCT02013622|3004236|Superiority or Other|||||||0.4265|||||||t-test, 2 sided|||Statistical analysis at Week 16 in DDT|
1635261|NCT02013622|3004237|Superiority or Other|||||||0.3401|||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task mean reaction time (no-go cues)|
1635262|NCT02013622|3004237|Superiority or Other|||||||0.8897|||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task mean reaction time (go cues)|
1635263|NCT02013622|3004238|Superiority or Other|||||||0.3774|||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (no-go cues)|
1635264|NCT02013622|3004238|Superiority or Other|||||||0.5133|||||||t-test, 2 sided|||Statistical analysis at Week 16 in Go/No-go task p-inhibition failures (go cues)|
1635265|NCT02013622|3004239|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 global satisfaction|
1635266|NCT02013622|3004239|Superiority or Other||||||<|0.0005|||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 convenience|
1635267|NCT02013622|3004239|Superiority or Other||||||<|0.0031|||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 side effects|
1635268|NCT02013622|3004239|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16 in TSQM-14 effectiveness|
1635269|NCT02013622|3004240|Superiority or Other|||||||0.0177|||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16|
1635270|NCT02013622|3004241|Superiority or Other|||||||0.0002|||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16|
1635271|NCT02013622|3004242|Superiority or Other|||||||0.0003|||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16|
1635272|NCT02013622|3004245|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16|
1635273|NCT02013622|3004246|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|MMRM method with model terms: baseline, visit, and baseline by visit interaction.||Statistical analysis at Week 16|
1635274|NCT02013622|3004247|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Mixed model repeated measures (MMRM) method with model terms: baseline, visit, and baseline by visit interaction.||The null hypothesis of zero in mean change from Baseline in PANSS Total Score at Week 16 was tested at significance level of 0.05. Since this is an exploratory trial, no methods to control type I error rate were performed.|
1635275|NCT02013609|3004248|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.|
1635276|NCT02013609|3004249|Superiority or Other|||||||0.8138|||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for money)|
1635277|NCT02013609|3004250|Superiority or Other|||||||0.8138|||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for money)|
1635278|NCT02013609|3004250|Superiority or Other|||||||0.261|||||||t-test, 2 sided|||Statistical analysis at Week 12 (AUC for food)|
1635279|NCT02013609|3004251|Superiority or Other|||||||0.3799|||||||t-test, 2 sided|||Statistical analysis at Week 12 for delay discounting task h value|
1635280|NCT02013609|3004251|Superiority or Other|||||||0.3517|||||||t-test, 2 sided|||Statistical analysis at Week 12 for delay discounting task k value|
1635281|NCT02013609|3004252|Superiority or Other|||||||0.3352|||||||t-test, 2 sided|||Statistical analysis at Week 12|
1635282|NCT02013609|3004253|Superiority or Other|||||||0.3169|||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12|
1635283|NCT02013609|3004254|Superiority or Other|||||||0.3224|||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for mean reaction time (No-Go cues)|
1635284|NCT02013609|3004254|Superiority or Other|||||||0.2052|||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for mean reaction time (Go cues)|
1635285|NCT02013609|3004255|Superiority or Other|||||||0.3385|||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for p-inhibition failures (No-Go cues)|
1635286|NCT02013609|3004255|Superiority or Other|||||||0.3439|||||||t-test, 2 sided|p-value for change from Baseline using t-test.||Statistical analysis at Week 12 for p-inhibition failures (Go cues)|
1635287|NCT02013609|3004256|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12|
1635288|NCT02013609|3004257|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12|
1635289|NCT02013609|3004258|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.|
1635290|NCT02013609|3004259|Superiority or Other||||||<|0.0001||||||The p-value is the same for each of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities|Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12 of single item sub-scores of tasks: work/ school, social life and family life/ home responsibilities|
1635291|NCT02013609|3004260|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.|
1635292|NCT02013609|3004261|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction.||Statistical analysis at Week 12.|
1635293|NCT02013609|3004266|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 12.|
1635294|NCT02013609|3004267|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in mean change from Baseline in MADRS total score at Week 12 was tested at significance level of 0.05. Since this is an exploratory trial, no methods to control type I error rate were performed.|
1635295|NCT02013531|3004288|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in Mean change from Baseline in HAM-A total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.|
1635296|NCT02013531|3004294|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Mixed model repeated measure (MMRM) with model terms: Baseline, visit, and Baseline by visit interaction||Statistical analysis at Week 6.|
1635297|NCT02013531|3004295|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|MMRM with model terms: Baseline, visit, and Baseline by visit interaction||The null hypothesis of zero in mean change from Baseline in the MADRS total score at Week 6 was tested at a significance level of 0.05. Because this was an exploratory trial, no methods to control type I error rate were performed.|
1635298|NCT02013167|3004325|Superiority or Other||Hazard Ratio (HR)|0.55|||||2-Sided|95.0|0.43|0.71|||||The hazard ratio estimates were obtained from the Cox Proportional Hazard Model. A hazard ratio < 1.0 indicates a lower average event rate and a longer survival for Blinatumomab relative to SOC Chemotherapy.||
1635299|NCT02013167|3004326|Superiority or Other||Treatment difference|19.3|||<|0.001|2-Sided|95.0|9.9|28.7|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors: age (< 35 vs. ≥ 35), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).|||
1635384|NCT02008227|3004643|Superiority or Other (legacy)||Unstratified Hazard Ratio|0.32|||||2-Sided|95.0|0.21|0.48|||||||
1635300|NCT02013167|3004327|Superiority or Other||Treatment difference|17.9|||<|0.001|2-Sided|95.0|9.6|26.2|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors: age (< 35 vs. ≥ 35), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).|||
1635301|NCT02013167|3004328|Superiority or Other||Hazard Ratio (HR)|0.71||||0.012|2-Sided|95.0|0.55|0.93|||Stratified Log Rank|Stratified by age (< 35 years; ≥ 35 years), prior salvage therapy (yes vs. no), and prior allogeneic HSCT (yes vs. no).|Hazard ratio obtained from the Cox Proportional Hazard Model. A hazard ratio < 1.0 indicated a lower average event rate and longer survival time for blinatumomab relative to SOC chemotherapy.||
1635302|NCT02012621|3004345|Other||Odds Ratio (OR)|4.7|||<|0.0001|2-Sided|95.0|2.6|8.7|||Regression, Logistic||||
1635303|NCT02012621|3004346|Other||Odds Ratio (OR)|8.5||||0.0012|2-Sided|95.0|2.3|30.9|||Regression, Logistic||||
1635304|NCT02012621|3004347|Other||Odds Ratio (OR)|73.5|||<|0.0001|2-Sided|95.0|25.7|210.5|||Regression, Logistic||||
1635305|NCT02012582|3004350|Superiority or Other||||||<|0.01|||||||Kruskal-Wallis|||Placebo versus pooled VAS203 Arms/Group|
1635306|NCT02012582|3004351|Superiority or Other||||||<|0.04||||||Mixed model analysis for TIL with the patient as random effect and study day, cohort, treatment, and interaction between study day and treatment as fixed effects.|Mixed Models Analysis|||Placebo versus pooled VAS203 Arms/Groups|
1635307|NCT02012283|3004364|Other|paired t-test|Mean Difference (Final Values)|101.3||||0.031|2-Sided|||||p<0.05 is defined as significant.|t-test, 2 sided|||Comparison was made to the broccoli intake with and without spices among low restraint eaters vs. the change among high restraint eaters.|
1635308|NCT02012283|3004365|Other|paired t-test|Mean Difference (Final Values)|78.4||||0.001|2-Sided|95.0||||p<0.05 is defined as significant|t-test, 2 sided|||Difference between plain and spiced broccoli intake was compared.|
1635309|NCT02012218|3004366|Superiority or Other||||||<|0.0001||||||P-values were calculated according to testing a null hypothesis of zero mean change.|Mixed Models Analysis|This analysis was conducted using a mixed model repeated measures analysis on observed case data.||The null hypothesis of zero in mean change from baseline in MADRS total score at Week 6 was tested for each treatment group at significance level of 0.05 (2-sided).|
1635310|NCT02011893|3004392|Superiority or Other|||||||0.017||||||Superiority analysis performed|t-distribution|95% UCB and p-value for superiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.|||
1635311|NCT02011893|3004394|Superiority or Other|||||||0.083||||||Superiority analysis performed|McNemar||||
1635312|NCT02011893|3004395|Non-Inferiority or Equivalence|Non-inferiority margin is 7.5 points, where the Visual Analog Scale (VAS) scores were measured on a scale of 0 to 100. Testing was carried out at a 5% significance level.|||||<|0.001|||||||t-distribution|95% UCB and p-value for non-inferiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.|||
1635313|NCT02011490|3004409|Superiority or Other||Geometric least squares mean ratio|0.92|||||2-Sided|90.0|0.72|1.18|||||Difference in least squares means of log-transformed data (moderate renal impaired – healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect|
1635314|NCT02011490|3004409|Superiority or Other||Geometric least squares mean ratio|0.94|||||2-Sided|90.0|0.73|1.21|||||Difference in least squares means of log-transformed data (severe renal impaired – healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect|
1635315|NCT02011490|3004410|Superiority or Other||Geometric least squares mean ratio|2.42|||||2-Sided|90.0|1.84|3.18|||||Difference in least squares means of log-transformed data (moderate renal impaired – healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect|
1635316|NCT02011490|3004410|Superiority or Other||Geometric least squares mean ratio|5.49|||||2-Sided|90.0|4.18|7.22|||||Difference in least squares means of log-transformed data (severe renal impaired – healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect|
1635317|NCT02011490|3004411|Superiority or Other||Geometric least squares mean ratio|2.42|||||2-Sided|90.0|1.84|3.17|||||Difference in least squares means of log-transformed data (moderate renal impaired – healthy) was back transformed to geometric least squares mean ratio (moderate renal impaired/healthy)|Log-transformed plasma values were modeled using an ANOVA linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect|
1635318|NCT02011490|3004411|Superiority or Other||Geometric least squares mean ratio|5.42|||||2-Sided|90.0|4.12|7.11|||||Difference in least squares means of log-transformed data (severe renal impaired – healthy) was back transformed to geometric least squares mean ratio (severe renal impaired/healthy)|Log-transformed plasma values were modeled using an analysis of variance (ANOVA) linear fixed-effect model with population (severe insufficiency, moderate insufficiency, and healthy control) as a fixed effect|
1635319|NCT02011113|3004425|Superiority or Other|||||||0.0027||||||Based on one sample binomial test for dichotomized response proportion against the null hypothesis(H0: p = 0.1)|Binomial test for dichotomized response||||
1635320|NCT02010996|3004426|Superiority or Other|||||||0.05|||||||Chi-squared||||
1635321|NCT02010775|3004427|Other||Percentage Difference|54.3|||<|0.001|2-Sided|95.0|36.1|72.6|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.|||
1635322|NCT02010775|3004427|Other||Percentage Difference|54.3|||<|0.001|2-Sided|95.0|36.1|72.6|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.|||
1635323|NCT02010775|3004427|Other||Percentage Difference|48.2|||<|0.001|2-Sided|95.0|28.6|67.8|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using CMH tests stratified by baseline MMPS.|||
1635324|NCT02010775|3004427|Other||Percentage Difference|31.5|||<|0.008|2-Sided|95.0|9.8|53.3|||Cochran-Mantel-Haenszel|P-values for between-treatment comparisons were determined using Cochran-Mantel-Haenszel (CMH) tests stratified by baseline MMPS.|||
1635325|NCT02010775|3004428|Other||LS Mean Difference|-7.68|||<|0.001|2-Sided|95.0|-9.35|-6.0|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.|||
1635326|NCT02010775|3004428|Other||LS Mean Difference|-6.89|||<|0.001|2-Sided|95.0|-8.56|-5.22|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.|||
1635327|NCT02010775|3004428|Other||LS Mean Difference|-6.32|||<|0.001|2-Sided|95.0|-8.02|-4.62|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.|||
1635328|NCT02010775|3004428|Other||Least Squares Mean (LS) Mean Difference|-3.88|||<|0.001|2-Sided|95.0|-5.58|-2.19|||ANOVA|ANOVA model with treatment, and baseline MMPS grade as factors.|||
1635329|NCT02009865|3004523|Superiority or Other (legacy)||Median Difference (Final Values)|-10.3||||0.3034|2-Sided|95.0|-23.9|3.5||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression|
1635330|NCT02009865|3004524|Superiority or Other (legacy)||Median Difference (Final Values)|-0.3||||0.7117|2-Sided|95.0|-3.5|4.9||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression|
1635331|NCT02009865|3004525|Superiority or Other (legacy)||Median Difference (Final Values)|-9.0||||0.018|2-Sided|95.0|-14.8|-2.8||Adjusted by using Hommel's procedure|Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Missing values were imputed using probabilities of missing estimated from logistic regression|
1635332|NCT02009865|3004526|Superiority or Other (legacy)||Median Difference (Final Values)|-26.3||||0.0008|2-Sided|95.0|-40.5|-11.5|||Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure.|Main analysis with missing values imputed using probabilities of missing estimated from logistic regression|
1635333|NCT02009865|3004527|Superiority or Other (legacy)||Median Difference (Final Values)|-14.2||||0.017|2-Sided|95.0|-26.2|-2.8|||Wilcoxon (Mann-Whitney)||The estimated median difference and its 95% CI were based on Hodges Lehmann procedure|Missing values were imputed using probabilities of missing estimated from logistic regression|
1635334|NCT02009163|3004557|Superiority or Other||difference in LS mean|-5.6|||<|0.001|2-Sided|95.0|-7.2|-3.9||Nominal P-value not adjusted for multiplicity.|mixed-effects model for repeated measure|MMRM over all post-randomization visits during the randomized-withdrawal phase. Value for change from baseline = outcome variable.|||
1635335|NCT02009163|3004558|Superiority or Other||||||<|0.001||||||Unadjusted P-value for the difference in distribution between treatment groups in CGI-S.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test with a modified ridit score, adjusting for Visit 8 (Week 12) CGI-S as the covariate.|||
1635336|NCT02009163|3004559|Superiority or Other||difference in LS mean|-0.61|||<|0.001|2-Sided|95.0|-0.81|-0.42||Nominal P-value not adjusted for multiplicity.|mixed­ effects model for repeated measur|MMRM over all post-randomization visits during the randomized-withdrawal phase. Value for change from baseline = outcome variable.|||
1635337|NCT02009163|3004560|Superiority or Other||||||<|0.001||||||P-value based on a log-rank test, stratified by 4-week cessation status (Yes, No). 4-week cessation was defined as a subject having no binge days during the 4 weeks prior to randomization.|Log Rank||||
1635338|NCT02009046|3004561|Superiority||Odds Ratio (OR)|2.71||||0.003|2-Sided|95.0|1.44|5.09|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635339|NCT02009046|3004561|Superiority||Odds Ratio (OR)|1.97||||0.0002|2-Sided|95.0|1.39|2.8|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635340|NCT02009046|3004562|Superiority||Odds Ratio (OR)|0.0||||0.9973|2-Sided||||||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|No results provided, as model would not converge.||
1635341|NCT02009046|3004562|Superiority||Odds Ratio (OR)|0.87||||0.6861|2-Sided|95.0|0.44|1.71|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635342|NCT02009046|3004563|Superiority||Odds Ratio (OR)|1.15||||0.8059|2-Sided|95.0|0.36|3.62|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635343|NCT02009046|3004563|Superiority||Odds Ratio (OR)|1.04||||0.9085|2-Sided|95.0|0.54|2.01|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635344|NCT02009046|3004564|Superiority||Odds Ratio (OR)|0.56||||0.0741|2-Sided|95.0|0.29|1.06|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635345|NCT02009046|3004564|Superiority||Odds Ratio (OR)|0.75||||0.1335|2-Sided|95.0|0.52|1.09|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635346|NCT02009046|3004565|Superiority||Odds Ratio (OR)|0.77||||0.3809|2-Sided|95.0|0.43|1.4|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635347|NCT02009046|3004565|Superiority||Odds Ratio (OR)|1.13||||0.4645|2-Sided|95.0|0.82|1.56|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635348|NCT02009046|3004566|Superiority||Odds Ratio (OR)|0.72||||0.2956|2-Sided|95.0|0.39|1.34|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635535|NCT02005562|3004978|Superiority or Other|||||||0.479|||||||Chi-squared||||
1635349|NCT02009046|3004566|Superiority||Odds Ratio (OR)|1.04||||0.8102|2-Sided|95.0|0.75|1.44|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635350|NCT02009046|3004567|Superiority||Odds Ratio (OR)|0.85||||0.5869|2-Sided|95.0|0.45|1.58|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635351|NCT02009046|3004567|Superiority||Odds Ratio (OR)|1.25||||0.1763|2-Sided|95.0|0.9|1.73|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635352|NCT02009046|3004568|Superiority||Odds Ratio (OR)|1.73||||0.0211|2-Sided|95.0|1.09|2.75|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635353|NCT02009046|3004568|Superiority||Odds Ratio (OR)|1.37||||0.0218|2-Sided|95.0|1.05|1.78|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635354|NCT02009046|3004569|Superiority||Odds Ratio (OR)|0.49||||0.2117|2-Sided|95.0|0.16|1.53|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635355|NCT02009046|3004569|Superiority||Odds Ratio (OR)|0.62||||0.1006|2-Sided|95.0|0.35|1.1|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635356|NCT02009046|3004570|Superiority||Odds Ratio (OR)|0.6||||0.1083|2-Sided|95.0|0.32|1.13|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635357|NCT02009046|3004570|Superiority||Odds Ratio (OR)|0.96||||0.8083|2-Sided|95.0|0.67|1.37|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635358|NCT02009046|3004571|Superiority||Odds Ratio (OR)|0.75||||0.3718|2-Sided|95.0|0.39|1.44|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635359|NCT02009046|3004571|Superiority||Odds Ratio (OR)|1.09||||0.643|2-Sided|95.0|0.75|1.6|||Regression, Logistic|Multilevel model to account for classroom/school clusters. Adjusted for student/classroom gender, student/classroom sexual experience, pretest score.|||
1635360|NCT02008916|3004573|Superiority||Odds Ratio (OR)|19.39||||0.0046|2-Sided|95.0|2.49|150.79|||Regression, Logistic||||
1635361|NCT02008916|3004573|Superiority||Odds Ratio (OR)|7.71||||0.0593|2-Sided|95.0|0.92|64.42|||Regression, Logistic||||
1635362|NCT02008916|3004577|Superiority||Mean Difference (Final Values)|-1.23|Standard Error of the Mean|0.39||0.0018|2-Sided|95.0|-2.0|-0.46|||Mixed Models Analysis||||
1635363|NCT02008916|3004577|Superiority||Mean Difference (Final Values)|-0.83|Standard Error of the Mean|0.39||0.0347|2-Sided|95.0|-1.6|-0.06|||Mixed Models Analysis||||
1635364|NCT02008916|3004578|Superiority||Odds Ratio (OR)|4.21||||0.0004|2-Sided|95.0|1.89|9.38|||Regression, Logistic||||
1635365|NCT02008916|3004578|Superiority||Odds Ratio (OR)|4.46||||0.0002|2-Sided|95.0|2.01|9.92|||Regression, Logistic||||
1635366|NCT02008916|3004579|Superiority||Relative treatment effect|0.44|||<|0.0001|2-Sided|95.0|0.33|0.6|||Mixed Models Analysis||Relative treatment effect = exponential of the difference in LSM on the log e scale or the geometric LSM ratio on the original scale. For values less than 1, AIN457 has a greater reduction than Placebo.||
1635367|NCT02008916|3004579|Superiority||Relative treatment effect|0.51|||<|0.0001|2-Sided|95.0|0.38|0.68|||Mixed Models Analysis||Relative treatment effect = exponential of the difference in LSM on the log e scale or the geometric LSM ratio on the original scale. For values less than 1, AIN457 has a greater reduction than Placebo.||
1635368|NCT02008916|3004580|Superiority||Odds Ratio (OR)|2.81||||0.0051|2-Sided|95.0|1.36|5.78|||Regression, Logistic||||
1635369|NCT02008916|3004580|Superiority||Odds Ratio (OR)|2.59||||0.01|2-Sided|95.0|1.26|5.35|||Regression, Logistic||||
1635370|NCT02008916|3004581|Superiority||Odds Ratio (OR)|2.68||||0.0037|2-Sided|95.0|1.38|5.21|||Regression, Logistic||||
1635371|NCT02008916|3004581|Superiority||Odds Ratio (OR)|2.41||||0.0093|2-Sided|95.0|1.24|4.69|||Regression, Logistic||||
1635372|NCT02008890|3004588|Superiority||Mean Difference (Final Values)|-3.13||||0.1576|2-Sided|95.0|-7.14|0.88|||Regression, Linear|with factors treatment, country, body weight at baseline visit (> 90 kg or >= 90kg) and presence of plaque-type psoriasis|||
1635373|NCT02008890|3004588|Superiority||Mean Difference (Final Values)|-0.56||||0.9431|2-Sided|95.0|-4.59|3.47|||Regression, Linear|with factors treatment, country, body weight at baseline visit (> 90 kg or >= 90kg) and presence of plaque-type psoriasis|||
1635374|NCT02008890|3004589|Superiority||Odds Ratio (OR)|2.62||||0.0411|2-Sided|95.0|1.04|6.6|||Regression, Logistic|with factors treatment, country, body weight at baseline visit (> 90 kg or >= 90kg) and presence of plaque-type psoriasis|||
1635375|NCT02008890|3004589|Superiority||Odds Ratio (OR)|1.33||||0.5722|2-Sided|95.0|0.5|3.53|||Regression, Logistic|with factors treatment, country, body weight at baseline visit (> 90 kg or >= 90kg) and presence of plaque-type psoriasis|||
1635376|NCT02008617|3004610|Superiority or Other|||||||0.82|||||||Wilcoxon (Mann-Whitney)||||
1635377|NCT02008617|3004611|Superiority or Other|||||||0.78|||||||Wilcoxon (Mann-Whitney)||||
1635378|NCT02008617|3004612|Superiority or Other|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Plantar Flexion|
1635379|NCT02008617|3004612|Superiority or Other|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||At Rest|
1635380|NCT02008617|3004613|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)||||
1635381|NCT02008565|3004626|Superiority|||||||0.092||||||significance assessed at type 1 error alpha=0.05|Mixed Models Analysis|The models were adjusted for baseline Irritable Bowel Syndrome (IBS) status and clinical site.|||
1635382|NCT02008526|3004629|Superiority||F|0.16||||0.8494|2-Sided||||||ANOVA|2 Degrees of Freedom|||
1635385|NCT02008227|3004645|Superiority or Other (legacy)||Stratified Hazard Ratio|0.96||||0.4981|2-Sided|95.0|0.85|1.08|||Log Rank||||
1635386|NCT02008227|3004646|Superiority or Other (legacy)||Hazard Ratio (HR)|0.45|||<|0.0001|2-Sided|95.0|0.3|0.68|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).|
1635387|NCT02008227|3004647|Superiority or Other (legacy)||Hazard Ratio (HR)|0.64||||0.0012|2-Sided|95.0|0.49|0.84|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).|
1635388|NCT02008227|3004648|Superiority or Other (legacy)||Hazard Ratio (HR)|0.77||||0.0045|2-Sided|95.0|0.64|0.92|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).|
1635389|NCT02008227|3004649|Superiority or Other (legacy)||Hazard Ratio (HR)|0.8||||0.0012|2-Sided|95.0|0.7|0.92|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).|
1635390|NCT02008227|3004664|Superiority or Other (legacy)||Hazard Ratio (HR)|0.92||||0.5221|2-Sided|95.0|0.73|1.17|||Log Rank|||Arm/Shoulder Pain|
1635391|NCT02008227|3004664|Superiority or Other (legacy)||Hazard Ratio (HR)|0.97||||0.7406|2-Sided|95.0|0.81|1.16|||Log Rank|||Dyspnea: Unstratified Analysis|
1635392|NCT02008227|3004664|Superiority or Other (legacy)||Hazard Ratio (HR)|1.06||||0.6305|2-Sided|95.0|0.84|1.33|||Log Rank|||Cough: Unstratified Analysis|
1635393|NCT02008227|3004664|Superiority or Other (legacy)||Hazard Ratio (HR)|0.72||||0.0111|2-Sided|95.0|0.55|0.93|||Log Rank|||Pain in Chest: Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.|
1635394|NCT02008227|3004668|Superiority or Other (legacy)||Hazard Ratio (HR)|0.38||||0.0003|2-Sided|95.0|0.22|0.65|||Log Rank|||Unstratified Analysis|
1635395|NCT02008227|3004668|Superiority or Other (legacy)||Hazard Ratio (HR)|0.31||||0.0006|2-Sided|95.0|0.15|0.62|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.|
1635396|NCT02008227|3004669|Superiority or Other (legacy)||Hazard Ratio (HR)|0.34|||<|0.0001|2-Sided|95.0|0.21|0.55|||Log Rank|||Unstratified Analysis|
1635397|NCT02008227|3004669|Superiority or Other (legacy)||Hazard Ratio (HR)|0.31|||<|0.0001|2-Sided|95.0|0.18|0.55|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.|
1635398|NCT02008227|3004672|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.3249|2-Sided|95.0|0.74|1.1|||Log Rank|||Unstratified Analysis|
1635399|NCT02008227|3004672|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.3806|2-Sided|95.0|0.74|1.12|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.|
1635400|NCT02008227|3004673|Superiority or Other (legacy)||Hazard Ratio (HR)|0.93||||0.3596|2-Sided|95.0|0.81|1.08|||Log Rank|||Unstratified Analysis|
1635401|NCT02008227|3004673|Superiority or Other (legacy)||Hazard Ratio (HR)|0.95||||0.4928|2-Sided|95.0|0.82|1.1|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.|
1635402|NCT02008227|3004676|Superiority or Other (legacy)||Hazard Ratio (HR)|0.72||||0.0052|2-Sided|95.0|0.58|0.91|||Log Rank|||Unstratified Analysis|
1635403|NCT02008227|3004676|Superiority or Other (legacy)||Hazard Ratio (HR)|0.74||||0.0102|2-Sided|95.0|0.58|0.93|||Log Rank|||Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.|
1635404|NCT02008227|3004677|Superiority or Other (legacy)||Hazard Ratio (HR)|0.73||||0.0002|2-Sided|95.0|0.62|0.86|||Log Rank|||Unstratified Analysis|
1635405|NCT02008227|3004677|Superiority or Other (legacy)||Hazard Ratio (HR)|0.73||||0.0003|2-Sided|95.0|0.62|0.87|||Log Rank|||Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).|
1635406|NCT02007954|3004684|Other|||||||0.01||||||P-values < 0.05 considered statistically significant.|t-test, 2 sided|||Shapiro-Wilk test was run for normality. Baseline and follow-up AFP compared using two-tailed Student's t-test.|
1635407|NCT02007512|3004708|Other||Hazard Ratio (HR)|0.37||||0.0359|2-Sided|95.0|0.143|0.961|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.|
1635408|NCT02007512|3004708|Other||Hazard Ratio (HR)|0.522||||0.127|2-Sided|95.0|0.224|1.217|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.|
1635409|NCT02007512|3004709|Other||Hazard Ratio (HR)|0.968||||0.8817|2-Sided|95.0|0.632|1.483|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.|
1635410|NCT02007512|3004709|Other||Hazard Ratio (HR)|0.928||||0.7378|2-Sided|95.0|0.599|1.438|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.|
1635411|NCT02007512|3004726|Other||Hazard Ratio (HR)|0.554||||0.1936|2-Sided|95.0|0.225|1.363|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.|
1635412|NCT02007512|3004726|Other||Hazard Ratio (HR)|0.442||||0.0335|2-Sided|95.0|0.205|0.955|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.|
1635413|NCT02007512|3004727|Other||Hazard Ratio (HR)|1.022||||0.9212|2-Sided|95.0|0.659|1.586|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.|
1635414|NCT02007512|3004727|Other||Hazard Ratio (HR)|0.82||||0.3631|2-Sided|95.0|0.535|1.257|||Stratified log-rank|||Hazard ratio was based on stratified Cox regression model.|
1635415|NCT02007434|3004738|Superiority or Other||LS Mean Placebo-adjusted Difference|-0.09|Standard Error of the Mean|0.56||0.8754|2-Sided|95.0|-1.21|1.04|||ANCOVA||Paradigm 3 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.|
1635416|NCT02007434|3004738|Superiority or Other||LS Mean Placebo-adjusted Difference|0.06|Standard Error of the Mean|0.55||0.914|2-Sided|95.0|-1.03|1.15|||ANCOVA||Paradigm 2 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.|
1635417|NCT02007434|3004738|Superiority or Other||LS Mean Placebo-adjusted Difference|0.15|Standard Error of the Mean|0.56||0.7935|2-Sided|95.0|-0.98|1.27|||ANCOVA||Paradigm 2 - Paradigm 3|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.|
1635418|NCT02007434|3004738|Superiority or Other||LS Mean Placebo-adjusted Difference|0.3|Standard Error of the Mean|0.58||0.606|2-Sided|395.0|-0.86|1.46|||ANCOVA||Paradigm 1 - Paradigm 4|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.|
1635419|NCT02007434|3004738|Superiority or Other||LS Mean Placebo-adjusted Difference|0.39|Standard Error of the Mean|0.61||0.5206|2-Sided|95.0|-0.82|1.6|||ANCOVA||Paradigm 1 - Paradigm 3|Day 0, 1 Minute. Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.|
1635420|NCT02007434|3004738|Superiority or Other||LS Mean Placebo-adjusted Difference|0.24|Standard Error of the Mean|0.59||0.6803|2-Sided|95.0|-0.93|1.41|||ANCOVA||Paradigm 1 - Paradigm 2|Pairwise differences between paradigms for the placebo-adjusted differences were conducted using a two-way analysis of covariance (ANCOVA) with factors for treatment, paradigm, treatment-by-paradigm interaction, and covariate of baseline CR-SMFRS score.|
1635421|NCT02007369|3004739|Superiority or Other|||||||0.527|||||||Fisher Exact||||
1635422|NCT02007369|3004739|Superiority or Other|||||||0.023|||||||Fisher Exact||||
1635423|NCT02007369|3004740|Superiority or Other||Odds Ratio (OR)|0.78||||0.597|2-Sided|95.0|0.31|1.97|||Regression, Logistic||||
1635424|NCT02007369|3004740|Superiority or Other||Odds Ratio (OR)|0.61||||0.285|2-Sided|95.0|0.25|1.5|||Regression, Logistic||||
1635425|NCT02007369|3004741|Superiority or Other|||||||0.199|||||||Fisher Exact||||
1635426|NCT02007369|3004741|Superiority or Other|||||||0.002|||||||Fisher Exact||||
1635427|NCT02007369|3004742|Superiority or Other||Odds Ratio (OR)|1.05||||0.934|2-Sided|95.0|0.36|3.01|||Regression, Logistic||||
1635428|NCT02007369|3004742|Superiority or Other||Odds Ratio (OR)|0.21||||0.033|2-Sided|95.0|0.05|0.89|||Regression, Logistic||||
1635429|NCT02007278|3004752|Non-Inferiority or Equivalence|Power=95%; significance level=5%, characteristic operation curves were used with a non-central F distribution for the calculation of the sample size||||||0.451|||||||Wilcoxon (Mann-Whitney)||||
1635430|NCT02007252|3004753|Superiority or Other||||||=|0|||||||ANCOVA|||Month 12|
1635431|NCT02007252|3004753|Superiority or Other||||||=|0|||||||ANCOVA|||Month 3|
1635432|NCT02007200|3004757|Superiority or Other||||||<|0.005|||||||Linear Repeated Measures Model||||
1635433|NCT02006836|3004787|Superiority or Other||||||>|0.05|||||||t-test, 1 sided|||H0: AUC|
1635434|NCT02006836|3004788|Superiority or Other||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after dinner- ∆g before dinner = 0 H1：∆g after dinner- ∆g before dinner > 0 α=5%~g of dinner without pomelo=mean of 3 days of postprandial blood glucose after dinner - mean of 3 days of blood glucose before this dinner.~g of dinner with pomelo=mean of 3 days of postprandial blood glucose after dinner - mean of 3 days of blood glucose before this dinner."|
1635435|NCT02006836|3004789|Superiority or Other||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after lunch - ∆g before lunch = 0 H1：∆g after lunch - ∆g before lunch > 0 α=5%~g of lunch without pomelo=mean of 3 days of postprandial blood glucose after lunch - mean of 3 days of blood glucose before this lunch.~g of lunch with pomelo=mean of 3 days of postprandial blood glucose after lunch - mean of 3 days of blood glucose before this lunch."|
1635436|NCT02006836|3004790|Superiority or Other||||||>|0.05|||||||t-test, 1 sided|||"H0：∆g after breakfast- ∆g before breakfast = 0 H1：∆g after breakfast- ∆g before breakfast > 0 α=5%~g of breasfast without pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast.~g of breasfast with pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast."|
1635437|NCT02006836|3004791|Superiority or Other|||||||0.005|||||||t-test, 1 sided|||H0: GI of pomelo for diabetic patients - GI of pomelo for healthy people = 0 H1: GI of pomelo for diabetic patients - GI of pomelo for healthy people > 0 α=5%|
1635438|NCT02006732|3004816|Superiority or Other||Mean Difference (Final Values)|-0.022|Standard Error of the Mean|0.033||0.4974|2-Sided|95.0|-0.087|0.042|||Mixed Effects Model for Repeated Measure||||
1635439|NCT02006732|3004816|Superiority or Other||Mean Difference (Final Values)|0.284|Standard Error of the Mean|0.034|<|0.0001|2-Sided|95.0|0.217|0.35|||Mixed Effects Model for Repeated Measure||||
1635440|NCT02006732|3004816|Superiority or Other||Mean Difference (Final Values)|0.171|Standard Error of the Mean|0.034|<|0.0001|2-Sided|95.0|0.105|0.236|||Mixed Effects Model for Repeated Measure||||
1635441|NCT02006732|3004816|Superiority or Other||Mean Difference (Final Values)|0.455|Standard Error of the Mean|0.034|<|0.0001|2-Sided|95.0|0.387|0.522|||Mixed Effects Model for Repeated Measure||||
1635442|NCT02006732|3004816|Superiority or Other||Mean Difference (Final Values)|0.148|Standard Error of the Mean|0.033|<|0.0001|2-Sided|95.0|0.084|0.212|||Mixed Effects Model for Repeated Measure||||
1635443|NCT02006732|3004816|Superiority or Other||Mean Difference (Final Values)|0.432|Standard Error of the Mean|0.033|<|0.0001|2-Sided|95.0|0.366|0.498|||Mixed Effects Model for Repeated Measure||||
1635444|NCT02006732|3004817|Superiority or Other||Mean Difference (Final Values)|0.012|Standard Error of the Mean|0.189||0.9494|2-Sided|95.0|-0.359|0.383|||Mixed Effects Model for Repeated Measure||||
1635445|NCT02006732|3004817|Superiority or Other||Mean Difference (Final Values)|1.029|Standard Error of the Mean|0.194|<|0.0001|2-Sided|95.0|0.649|1.41|||Mixed Effects Model for Repeated Measure||||
1635446|NCT02006732|3004817|Superiority or Other||Mean Difference (Final Values)|0.582|Standard Error of the Mean|0.191|<|0.0023|2-Sided|95.0|0.207|0.956|||Mixed Effects Model for Repeated Measure||||
1635447|NCT02006732|3004817|Superiority or Other||Mean Difference (Final Values)|1.611|Standard Error of the Mean|0.193|<|0.0001|2-Sided|95.0|1.232|1.989|||Mixed Effects Model for Repeated Measure||||
1635448|NCT02006732|3004817|Superiority or Other||Mean Difference (Final Values)|0.594|Standard Error of the Mean|0.19|<|0.0019|2-Sided|95.0|0.22|0.967|||Mixed Effects Model for Repeated Measure||||
1635449|NCT02006732|3004817|Superiority or Other||Mean Difference (Final Values)|1.623|Standard Error of the Mean|0.193|<|0.0001|2-Sided|95.0|1.245|2.0|||Mixed Effects Model for Repeated Measure||||
1635450|NCT02006732|3004818|Superiority or Other||Mean Difference (Final Values)|-0.068|Standard Error of the Mean|0.266||0.7984|2-Sided|95.0|-0.59|0.454|||Mixed Effects Model for Repeated Measure||||
1635451|NCT02006732|3004818|Superiority or Other||Mean Difference (Final Values)|0.613|Standard Error of the Mean|0.273||0.0248|2-Sided|95.0|0.078|1.148|||Mixed Effects Model for Repeated Measure||||
1635452|NCT02006732|3004818|Superiority or Other||Mean Difference (Final Values)|0.65|Standard Error of the Mean|0.269||0.0159|2-Sided|95.0|0.122|1.178|||Mixed Effects Model for Repeated Measure||||
1635453|NCT02006732|3004818|Superiority or Other||Mean Difference (Final Values)|1.263|Standard Error of the Mean|0.272|<|0.0001|2-Sided|95.0|0.73|1.796|||Mixed Effects Model for Repeated Measure||||
1635454|NCT02006732|3004818|Superiority or Other||Mean Difference (Final Values)|0.582|Standard Error of the Mean|0.267|<|0.0296|2-Sided|95.0|0.058|1.106|||Mixed Effects Model for Repeated Measure||||
1635455|NCT02006732|3004818|Superiority or Other||Mean Difference (Final Values)|1.195|Standard Error of the Mean|0.27|<|0.0001|2-Sided|95.0|0.665|1.725|||Mixed Effects Model for Repeated Measure||||
1635456|NCT02006732|3004819|Superiority or Other||Mean Difference (Final Values)|-0.053|Standard Error of the Mean|0.033||0.1089|2-Sided|95.0|-0.117|0.012|||Mixed Effects Model for Repeated Measure||||
1635457|NCT02006732|3004819|Superiority or Other||Mean Difference (Final Values)|0.191|Standard Error of the Mean|0.033|<|0.0001|2-Sided|95.0|0.126|0.256|||Mixed Effects Model for Repeated Measure||||
1635458|NCT02006732|3004819|Superiority or Other||Mean Difference (Final Values)|0.114|Standard Error of the Mean|0.033|<|0.0005|2-Sided|95.0|0.049|0.178|||Mixed Effects Model for Repeated Measure||||
1635459|NCT02006732|3004819|Superiority or Other||Mean Difference (Final Values)|0.305|Standard Error of the Mean|0.033|<|0.0001|2-Sided|95.0|0.24|0.37|||Mixed Effects Model for Repeated Measure||||
1635460|NCT02006732|3004819|Superiority or Other||Mean Difference (Final Values)|0.061|Standard Error of the Mean|0.033|<|0.0614|2-Sided|95.0|-0.003|0.125|||Mixed Effects Model for Repeated Measure||||
1635461|NCT02006732|3004819|Superiority or Other||Mean Difference (Final Values)|0.252|Standard Error of the Mean|0.033|<|0.0001|2-Sided|95.0|0.187|0.317|||Mixed Effects Model for Repeated Measure||||
1635462|NCT02006732|3004820|Superiority or Other||Mean Difference (Final Values)|-0.822|Standard Error of the Mean|0.698||0.2387|2-Sided|95.0|-2.191|0.546|||Mixed Effects Model for Repeated Measure||||
1635463|NCT02006732|3004820|Superiority or Other||Mean Difference (Final Values)|-2.571|Standard Error of the Mean|0.714||0.0003|2-Sided|95.0|-3.971|-1.171|||Mixed Effects Model for Repeated Measure||||
1635464|NCT02006732|3004820|Superiority or Other||Mean Difference (Final Values)|-1.274|Standard Error of the Mean|0.702||0.0696|2-Sided|95.0|-2.651|0.102|||Mixed Effects Model for Repeated Measure||||
1635465|NCT02006732|3004820|Superiority or Other||Mean Difference (Final Values)|-3.846|Standard Error of the Mean|0.711|<|0.0001|2-Sided|95.0|-5.24|-2.451|||Mixed Effects Model for Repeated Measure||||
1635466|NCT02006732|3004820|Superiority or Other||Mean Difference (Final Values)|-2.097|Standard Error of the Mean|0.701|<|0.0028|2-Sided|95.0|-3.471|-0.723|||Mixed Effects Model for Repeated Measure||||
1635467|NCT02006732|3004820|Superiority or Other||Mean Difference (Final Values)|-4.668|Standard Error of the Mean|0.71|<|0.0001|2-Sided|95.0|-6.06|-3.276|||Mixed Effects Model for Repeated Measure||||
1635468|NCT02006732|3004821|Superiority or Other||Mean Difference (Final Values)|-0.898|Standard Error of the Mean|0.971||0.3555|2-Sided|95.0|-2.804|1.008|||Mixed Effects Model for Repeated Measure||||
1635469|NCT02006732|3004821|Superiority or Other||Mean Difference (Final Values)|-2.846|Standard Error of the Mean|0.993||0.0042|2-Sided|95.0|-4.796|-0.897|||Mixed Effects Model for Repeated Measure||||
1635470|NCT02006732|3004821|Superiority or Other||Mean Difference (Final Values)|-0.82|Standard Error of the Mean|0.979||0.4028|2-Sided|95.0|-2.741|1.102|||Mixed Effects Model for Repeated Measure||||
1635471|NCT02006732|3004821|Superiority or Other||Mean Difference (Final Values)|-3.666|Standard Error of the Mean|0.991||0.0002|2-Sided|95.0|-5.611|-1.721|||Mixed Effects Model for Repeated Measure||||
1635472|NCT02006732|3004821|Superiority or Other||Mean Difference (Final Values)|-1.717|Standard Error of the Mean|0.974||0.078|2-Sided|95.0|-3.628|0.193|||Mixed Effects Model for Repeated Measure||||
1635473|NCT02006732|3004821|Superiority or Other||Mean Difference (Final Values)|-4.564|Standard Error of the Mean|0.986|<|0.0001|2-Sided|95.0|-6.499|-2.629|||Mixed Effects Model for Repeated Measure||||
1635474|NCT02006732|3004822|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.019||0.8669|2-Sided|95.0|-0.04|0.034|||Mixed Effects Model for Repeated Measure||||
1635475|NCT02006732|3004822|Superiority or Other||Mean Difference (Final Values)|0.127|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.09|0.165|||Mixed Effects Model for Repeated Measure||||
1635476|NCT02006732|3004822|Superiority or Other||Mean Difference (Final Values)|0.042|Standard Error of the Mean|0.019|<|0.0269|2-Sided|95.0|0.005|0.079|||Mixed Effects Model for Repeated Measure||||
1635477|NCT02006732|3004822|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.132|0.207|||Mixed Effects Model for Repeated Measure||||
1635478|NCT02006732|3004822|Superiority or Other||Mean Difference (Final Values)|0.039|Standard Error of the Mean|0.019|<|0.0395|2-Sided|95.0|0.002|0.076|||Mixed Effects Model for Repeated Measure||||
1635479|NCT02006732|3004822|Superiority or Other||Mean Difference (Final Values)|0.166|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.129|0.203|||Mixed Effects Model for Repeated Measure||||
1635480|NCT02006732|3004823|Superiority or Other||Mean Difference (Final Values)|0.014|Standard Error of the Mean|0.019||0.4499|2-Sided|95.0|-0.023|0.051|||Mixed Effects Model for Repeated Measure||||
1635481|NCT02006732|3004823|Superiority or Other||Mean Difference (Final Values)|0.194|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.156|0.232|||Mixed Effects Model for Repeated Measure||||
1635482|NCT02006732|3004823|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.053|0.128|||Mixed Effects Model for Repeated Measure||||
1635483|NCT02006732|3004823|Superiority or Other||Mean Difference (Final Values)|0.284|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.246|0.323|||Mixed Effects Model for Repeated Measure||||
1635484|NCT02006732|3004823|Superiority or Other||Mean Difference (Final Values)|0.105|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.069|0.141|||Mixed Effects Model for Repeated Measure||||
1635485|NCT02006732|3004823|Superiority or Other||Mean Difference (Final Values)|0.299|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.261|0.336|||Mixed Effects Model for Repeated Measure||||
1635486|NCT02006706|3004837|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1635487|NCT02006706|3004838|Superiority or Other||Mean Difference (Final Values)|2.98|Standard Error of the Mean|0.606|<|0.001|2-Sided|95.0|1.73|4.22|||t-test, 2 sided||The null hypothesis was that there was no difference between the DAS28 at baseline and DAS28 after 24 weeks of follow-up||
1635488|NCT02006654|3004858|Superiority||Mean Difference (Final Values)|0.67|Standard Error of the Mean|0.63||0.4064|2-Sided|95.0|-0.57|1.92||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested at significance level 5%.|
1635489|NCT02006654|3004859|Superiority||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.08||0.4064|2-Sided|95.0|-0.09|0.23||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A negative mean difference indicates a treatment effect in favor of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested at significance level 5%.|
1635490|NCT02006654|3004860|Superiority||Mean Difference (Final Values)|-0.55|Standard Error of the Mean|0.46||0.2365|2-Sided|95.0|-1.45|0.36||Corrected for multiplicity|Mixed Models Analysis|Adjusted for effects of country, MMSE stratum-by-week, treatment-by-week, base treatment stratum-by-week, and baseline score-by-week interactions|A negative mean difference indicates a treatment effect in favor of idalopirdine|For demonstrating efficacy, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for idalopirdine at significance level 5%.|
1635491|NCT02006641|3004869|Superiority||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.09||1|2-Sided|95.0|-0.12|0.21||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.|
1635492|NCT02006641|3004869|Superiority||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.08||1|2-Sided|95.0|-0.23|0.1||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.|
1635493|NCT02006641|3004870|Superiority||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.66||1|2-Sided|95.0|-1.27|1.33||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.|
1635494|NCT02006641|3004870|Superiority||Mean Difference (Net)|0.17|Standard Error of the Mean|0.65||1|2-Sided|95.0|-1.11|1.46||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.|
1635495|NCT02006641|3004871|Superiority||Mean Difference (Final Values)|0.63|Standard Error of the Mean|0.52||0.2223|2-Sided|95.0|-0.38|1.65||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.|
1635496|NCT02006641|3004871|Superiority||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.51||1|2-Sided|95.0|-1.1|0.92||Corrected for multiplicity|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) at Week 24 had to show statistically significant favourable differences compared to placebo at Week 24. Overall, type 1 error was controlled at 5% by multiplicity adjustment. Testing of the doses was done in a gated manner, first testing 30 mg at a 5% significance level, and only if found efficacious, then moving on to 10 mg.|
1635497|NCT02006628|3004872|Superiority||Treatment difference (GWP42003-placebo)|1.31||||0.0677|2-Sided|95.0|-0.1|2.72|||ANCOVA||||
1635498|NCT02006628|3004873|Superiority||Treatment difference (GWP42003-placebo)|-0.5||||0.0182|2-Sided|95.0|-0.8|-0.1|||ANCOVA||||
1635499|NCT02006628|3004874|Superiority||Treatment difference (GWP42003-placebo)|-0.3||||0.0443|2-Sided|95.0|-0.5|0.0|||ANCOVA||||
1635500|NCT02006628|3004875|Superiority||Treatment difference (GWP42003-placebo)|-3.5||||0.1167|2-Sided|95.0|-7.9|0.9|||ANCOVA||||
1635501|NCT02006628|3004876|Superiority||Treatment difference (GWP42003-placebo)|-1.3||||0.1963|2-Sided|95.0|-3.2|0.7|||ANCOVA||||
1635502|NCT02006628|3004877|Superiority||Treatment difference (GWP42003-placebo)|0.0||||0.9647|2-Sided|95.0|-1.3|1.4|||ANCOVA||||
1635503|NCT02006628|3004878|Superiority||Treatment difference (GWP42003-placebo)|-1.4||||0.0188|2-Sided|95.0|-2.5|-0.2|||ANCOVA||||
1635504|NCT02006628|3004879|Superiority||Odds Ratio (OR)|2.62||||0.0896|2-Sided|95.0|0.86|8.0|||Regression, Logistic|Responder (yes/no) is the dependent variable with treatment included as factor and age and baseline P, G, and N scores included as covariates.|||
1635505|NCT02006628|3004880|Superiority||Treatment difference (GWP42003-placebo)|-2.8||||0.1332|2-Sided|95.0|-6.5|0.9|||ANCOVA|Change from baseline as the response variable, treatment as fixed effect, and individual baseline subscore and age as covariates.|||
1635506|NCT02006420|3004915|Superiority|||||||0.1|||||||Pearson correlation|||This is the p-value for the thigh|
1635507|NCT02006420|3004915|Superiority|||||||0.01|||||||Pearson correlation|||This is the p-value for the forearm|
1635508|NCT02006420|3004917|Superiority||||||<|0.0001|||||||Pearson correlation|||This is the p-value for the thigh|
1635509|NCT02006420|3004917|Superiority||||||<|0.0001|||||||Pearson correlation|||This is the p-value for the forearm|
1635510|NCT02006420|3004919|Superiority|||||||0.007|||||||Pearson correlation|||This is the p value for the thigh|
1635511|NCT02006420|3004919|Superiority|||||||0.002|||||||Pearson correlation|||This is the p value for the forearm.|
1635512|NCT02006420|3004920|Superiority|||||||0.007|||||||Pearson correlation|||This is the p-value for the thigh|
1635513|NCT02006420|3004920|Superiority|||||||0.002|||||||Pearson correlation|||This is the p-value for the forearm|
1635514|NCT02006420|3004921|Superiority|||||||0.71|||||||t-test, 2 sided|Unequal variance assumption||This is the p value for the mean skin stiffness of the thigh|
1635515|NCT02006420|3004921|Superiority|||||||0.005|||||||t-test, 2 sided|Unequal variance assumption||This is the p value for the mean skin thickness of the forearm.|
1635516|NCT02006121|3004938|Superiority||||||<|0.0001|||||||Mixed Models Analysis||||
1635517|NCT02006121|3004939|Superiority|||||||0.005|||||||Mixed Models Analysis||||
1635518|NCT02006121|3004940|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1635519|NCT02006121|3004941|Superiority|||||||0.0022|||||||Mixed Models Analysis||||
1635520|NCT02006121|3004942|Superiority|||||||0.0047|||||||Mixed Models Analysis||||
1635521|NCT02005627|3004959|Superiority|||||||||||||||||Null Hypothesis was no difference between Grazax and Placebo treatment at 12 months. 80% power to detect 30% difference in total nasal symptom score (TNSS) after nasal challenge|Comparison of nasal symptom score at 0-60 mins after nasal challenge after 12 months treatment with Grazax compared to Placebo treatment. Mixed model analysis. 80% power to detect a 30% difference at p<0.05.
1635522|NCT02005627|3004960|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1635523|NCT02005627|3004963|Superiority||||||<|0.05||||||calculated|t-test, 2 sided||||
1635524|NCT02005562|3004968|Superiority or Other|||||||0.86|||||||Log Rank||||
1635525|NCT02005562|3004970|Superiority or Other|||||||0.718||||||Mycophenolate Mofetil, Adapted Dose vs. Mycophenolate Mofetil, Fixed Dose at protocol biopsy at Week 52.|Fisher Exact||||
1635526|NCT02005562|3004970|Superiority or Other|||||||0.512||||||Mycophenolate Mofetil, Adapted Dose vs. Mycophenolate Mofetil, Fixed Dose at protocol biopsy at Week 12.|Fisher Exact||||
1635527|NCT02005562|3004971|Superiority or Other|||||||0.637|||||||Fisher Exact|||Week 52|
1635528|NCT02005562|3004971|Superiority or Other|||||||0.245|||||||Fisher Exact|||Week 12|
1635529|NCT02005562|3004972|Superiority or Other|||||||0.841|||||||Fisher Exact|||Week 52|
1635530|NCT02005562|3004972|Superiority or Other|||||||0.418|||||||Fisher Exact|||Week 12|
1635531|NCT02005562|3004973|Superiority or Other|||||||0.0764|||||||Log Rank||||
1635532|NCT02005562|3004975|Superiority or Other|||||||0.477|||||||ANOVA||||
1635533|NCT02005562|3004976|Superiority or Other|||||||0.2172|||||||ANOVA||||
1635534|NCT02005562|3004977|Superiority or Other|||||||0.6736|||||||ANOVA||||
1635536|NCT02005471|3005000|Superiority||Odds Ratio (OR)|10.77|||||2-Sided|95.0|6.5|17.85|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.||
1635537|NCT02005471|3005000|Superiority||Difference in MRD Negativity Rates|49.04|||<|0.0001|2-Sided|95.0|40.44|57.64|||Chi-squared||The 95% CI was computed using Anderson-Hauck method.||
1635538|NCT02005471|3005001|Superiority||Hazard Ratio (HR)|0.19|||<|0.0001|2-Sided|95.0|0.12|0.31|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis|
1635539|NCT02005471|3005001|Superiority||Hazard Ratio (HR)|0.19|||<|0.0001|2-Sided|95.0|0.12|0.31|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.|
1635540|NCT02005471|3005005|Superiority||Hazard Ratio (HR)|0.18|||<|0.0001|2-Sided|95.0|0.12|0.26|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis|
1635541|NCT02005471|3005005|Superiority||Hazard Ratio (HR)|0.17|||<|0.0001|2-Sided|95.0|0.11|0.25|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.|
1635542|NCT02005471|3005007|Superiority||Hazard Ratio (HR)|0.48||||0.019|2-Sided|95.0|0.25|0.9|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis|
1635543|NCT02005471|3005007|Superiority|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.|Hazard Ratio (HR)|0.48||||0.0186|2-Sided|95.0|0.25|0.9|||Log Rank||Hazard ratio was estimated by Cox regression model.||
1635544|NCT02005471|3005009|Superiority||Odds Ratio (OR)|4.59|||||2-Sided|95.0|2.68|7.85|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.||
1635545|NCT02005471|3005009|Superiority||Difference in Response Rates|24.55|||<|0.0001|2-Sided|95.0|16.0|33.1|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.||
1635546|NCT02005471|3005010|Superiority||Odds Ratio (OR)|4.75|||||2-Sided|95.0|2.76|8.16|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.||
1635547|NCT02005471|3005010|Superiority||Difference in Response Rates|25.58|||<|0.0001|2-Sided|95.0|17.13|34.03|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.||
1635548|NCT02005471|3005011|Superiority||Odds Ratio (OR)|4.79|||||2-Sided|95.0|2.56|8.99|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.||
1635549|NCT02005471|3005011|Superiority||Difference in Response Rates|19.96|||<|0.0001|2-Sided|95.0|12.36|27.56|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.||
1635550|NCT02005471|3005012|Superiority||Odds Ratio (OR)|7.81|||||2-Sided|95.0|3.97|15.37|||||OR was estimated using logistic regression model. The 95% CI was computed using Wald test.||
1635551|NCT02005471|3005012|Superiority||Difference in Response Rates|25.61|||<|0.0001|2-Sided|95.0|17.88|33.33|||Cochran-Mantel-Haenszel||The 95% CI was computed using Anderson-Hauck method.||
1635552|NCT02005471|3005013|Superiority||Hazard Ratio (HR)|0.21|||<|0.0001|2-Sided|95.0|0.09|0.46|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis|
1635553|NCT02005471|3005013|Superiority||Hazard Ratio (HR)|0.21|||<|0.0001|2-Sided|95.0|0.09|0.49|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factor: geographic region.|
1635554|NCT02005471|3005015|Superiority||Hazard Ratio (HR)|0.13|||<|0.0001|2-Sided|95.0|0.05|0.29|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis|
1635555|NCT02005471|3005015|Superiority||Hazard Ratio (HR)|0.13|||<|0.0001|2-Sided|95.0|0.05|0.31|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factor: geographic region.|
1635556|NCT02005471|3005017|Superiority||Hazard Ratio (HR)|0.2|||<|0.0001|2-Sided|95.0|0.14|0.3|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis|
1635557|NCT02005471|3005017|Superiority||Hazard Ratio (HR)|0.19|||<|0.0001|2-Sided|95.0|0.13|0.28|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.|
1635558|NCT02005471|3005019|Superiority||Hazard Ratio (HR)|0.17|||<|0.0001|2-Sided|95.0|0.12|0.26|||Log Rank||Hazard ratio was estimated by Cox regression model.|Unstratified Analysis|
1635559|NCT02005471|3005019|Superiority||Hazard Ratio (HR)|0.17|||<|0.0001|2-Sided|95.0|0.11|0.25|||Log Rank||Hazard ratio was estimated by Cox regression model.|Stratified Analysis; Stratification factors: 17p deletion, risk status, geographic region.|
1635560|NCT02005393|3005022|Non-Inferiority or Equivalence|Image settings were considered non-inferior if scores overlapped within 1 SD of mean.||||||||||||||||All 20 subjects enrolled in the study, including Subject 219 that was dropped from the Reader assessments due to corrupted images, were all rated as having similar white light images between the FICE and NBI procedures for each location used in the concurrence study. This assessment was intended to assure that no procedural sequence or visualization bias was introduced into the image acquisition process. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).|The results reported utilized the average Likert scores for each of the 3 readers, for each of the FICE settings (0-9), as compared to FICE. The overall Reader mean (SD) for both FICE and NBI were equal to or greater than 3.0 (0.8).The overall mean scores were comparable between FICE and NBI to provide acceptable diagnostic image visualization quality.
1635561|NCT02005029|3005031|Superiority or Other||Erythromycin:Placebo Cmax ratio|0.83|Standard Deviation|0.24|||2-Sided||||||||||
1635562|NCT02005029|3005032|Superiority or Other||Mean Difference (Final Values)|4.75|Standard Deviation|5.0||0.0314|2-Sided||||||t-test, 2 sided||"Mean difference in on score versus off score from the MDS UPDRS Part 3 on day of erythromycin minus the mean difference in 'on score versus off score on day of placebo."||
1635563|NCT02005029|3005033|Superiority or Other|||||||0.1546|||||||t-test, 2 sided||||
1635564|NCT02005029|3005034|Superiority or Other|||||||0.832|||||||t-test, 2 sided||||
1635565|NCT02005029|3005035|Superiority or Other|||||||0.8923|||||||t-test, 2 sided||||
1635566|NCT02005029|3005036|Superiority or Other|||||||0.6011|||||||t-test, 2 sided||||
1635567|NCT02005029|3005037|Superiority or Other|||||||0.4405|||||||t-test, 2 sided||||
1635568|NCT02005029|3005038|Superiority or Other|||||||0.18|||||||t-test, 2 sided||||
1635569|NCT02005029|3005039|Superiority or Other|||||||0.65|||||||t-test, 2 sided||||
1635570|NCT02005029|3005040|Superiority or Other||Erythromycin:Placebo AUC ratio|1.07|Standard Deviation|0.43|||2-Sided||||||||||
1635571|NCT02005029|3005041|Superiority or Other|||||||0.036|||||||t-test, 2 sided||||
1635572|NCT02005016|3005042|Other|This was a single-group study. A t-test was administered comparing pre- and post-treatment CAT modality mean T-scores (range: 30-70, mean: 50; higher scores are better).|||||<|0.001|||||||t-test, 1 sided||||
1635573|NCT02005016|3005043|Other|This was a single-group study. A t-test was administered comparing pre- and post-treatment PNT scores (range: 1-175; higher scores are better).|||||<|0.005|||||||t-test, 1 sided||||
1635574|NCT02004886|3005051|Superiority or Other||Mean Difference (Final Values)|-6.6||||0.63|2-Sided|95.0|-34.0|20.8|||ANCOVA||||
1635575|NCT02004886|3005051|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.906|2-Sided|95.0|-30.3|26.9|||ANCOVA||||
1635576|NCT02004886|3005051|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.857|2-Sided|95.0|-30.4|25.3|||ANCOVA||||
1635577|NCT02004886|3005052|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.906|2-Sided|95.0|-2.8|2.5|||ANCOVA||||
1635578|NCT02004886|3005052|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.741|2-Sided|95.0|-3.1|2.2|||ANCOVA||||
1635579|NCT02004886|3005052|Superiority or Other||Mean Difference (Final Values)|1.1||||0.408|2-Sided|95.0|-1.5|3.7|||ANCOVA||||
1635580|NCT02004886|3005053|Superiority or Other||Mean Difference (Final Values)|-97.7||||0.001|2-Sided|95.0|-152.4|-42.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.|||
1635581|NCT02004886|3005053|Superiority or Other||Mean Difference (Final Values)|-191.1|||<|0.001|2-Sided|95.0|-246.4|-135.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.|||
1635582|NCT02004886|3005053|Superiority or Other||Mean Difference (Final Values)|-89.9|||<|0.002|2-Sided|95.0|-145.6|-34.0|||ANCOVA|Relevant baseline efficacy measurements were the covariates.|||
1635583|NCT02004886|3005054|Superiority or Other||Mean Difference (Final Values)|-26.1|||<|0.001|2-Sided|95.0|-39.5|-12.8|||ANCOVA||||
1635584|NCT02004886|3005054|Superiority or Other||Mean Difference (Final Values)|-12.5|||<|0.07|2-Sided|95.0|-26.0|1.0|||ANCOVA||||
1635585|NCT02004886|3005054|Superiority or Other||Mean Difference (Final Values)|-7.7|||<|0.253|2-Sided|95.0|-21.1|5.6|||ANCOVA||||
1635586|NCT02004886|3005056|Superiority or Other||Mean Difference (Final Values)|0.0||||0.918|2-Sided|95.0|-0.8|0.8|||ANCOVA||||
1635587|NCT02004886|3005056|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.581|2-Sided|95.0|-1.0|0.6|||ANCOVA||||
1635588|NCT02004886|3005056|Superiority or Other||Mean Difference (Final Values)|0.1||||0.751|2-Sided|95.0|-0.7|0.9|||ANCOVA||||
1635589|NCT02004886|3005058|Superiority or Other||Mean Difference (Final Values)|-8.6||||0.32|2-Sided|95.0|-25.7|8.5|||ANCOVA|Relevant baseline efficacy measurements were the covariates.|||
1635590|NCT02004886|3005058|Superiority or Other||Mean Difference (Final Values)|-43.6|||<|0.001|2-Sided|95.0|-60.9|-26.3|||ANCOVA|Relevant baseline efficacy measurements were the covariates.|||
1635591|NCT02004886|3005058|Superiority or Other||Mean Difference (Final Values)|-18.3|||<|0.04|2-Sided|95.0|-35.7|-0.9|||ANCOVA|Relevant baseline efficacy measurements were the covariates.|||
1635592|NCT02004886|3005061|Superiority or Other||Mean Difference (Final Values)|-26.0|||<|0.001|2-Sided|95.0|-38.4|-13.6|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.|||
1635593|NCT02004886|3005061|Superiority or Other||Median Difference (Final Values)|-53.6|||<|0.001|2-Sided|95.0|-66.1|-41.1|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.|||
1635594|NCT02004886|3005061|Superiority or Other||Mean Difference (Final Values)|-25.9|||<|0.001|2-Sided|95.0|-38.4|-13.3|||ANCOVA|Terms for treatment, prior AHA therapy status, and baseline 24-hour WMG value as a covariate.|||
1635595|NCT02004873|3005062|Non-Inferiority or Equivalence|The equivalence margin is 0.35. The Micra sensor indicated rate is considered proportional to the workload if the 90% CI for the Kay-Wilkoff slope parameter falls into [0.65, 1.35].|Slope|0.864|||<|0.001|2-Sided|90.0|0.768|0.961||Holm adjustment for multiple comparisons for secondary objectives was used. Two One-sided Test (TOST) procedure was used at the 0.05 significance level.|t-test, 1 sided|Two One-sided Test (TOST)|A random effect linear regression model was used to assess if the Micra sensor-indicated rate was proportional to the workload using the Kay-Wilkoff model. The Kay-Wilkoff slope parameter was estimated along with its 90% CI.|Null hypothesis: Kay-Wilkoff slope parameter is < 0.65 or > 1.35 Alternative hypothesis: Kay-Wilkoff slope parameter is between 0.65 and 1.35|
1635596|NCT02004873|3005063|Superiority or Other||Percentage of subjects (%)|99.6|||<|0.0001|2-Sided|98.66|97.5|100.0||Holm adjustment for multiple comparisons for secondary objectives was used. The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|Exact Binomial test||The coverage level for confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis.|"Null hypothesis: Percentage of subjects with VCMT within 0.5 Volts of auto decrement PCT at 6 months post-implant is less than or equal to 85%.~Alternative hypothesis: Percentage of subjects with VCMT within 0.5 Volts of auto decrement PCT at 6 months post-implant is greater than 85%."|
1635597|NCT02004873|3005064|Superiority or Other||Percentage of subjects (%)|98.3|||<|0.0001|2-Sided|98.66|95.4|99.6||The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|Exact Binomial test||The coverage level for confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis.|"Null hypothesis: Percentage of subjects with an adequate pacing capture threshold at 6-months post-implant is less than or equal to 80%.~Alternative hypothesis: Percentage of subjects with an adequate pacing capture threshold at 6-months post-implant is greater than 80%."|
1635653|NCT02002221|3005293|Superiority or Other||Mean Difference (Net)|-0.91|Standard Error of the Mean|0.09|<|0.001|2-Sided|95.0|-1.08|-0.73|||ANCOVA|||H0: δ vildagliptin 50 mg bid = δ placebo versus H1: δ Vildagliptin 50 mg bid < δ placebo,|
1635654|NCT02002091|3005296|Other|||||||0.059||||||the threshold for statistical significance used is P-value <0.05|Fisher Exact||||
1635655|NCT02002091|3005299|Other|||||||0.025||||||The threshold of statistical difference is P-value < 0.05|Chi-squared, Corrected||||
1635598|NCT02004873|3005065|Superiority or Other||Kaplan-Meier survival probability (%)|96.0|||<|0.0001|2-Sided|98.66|93.3|97.6||The threshold for statistical significance was 0.0067, determined by the pre-specified alpha spending function for the interim analysis.|z-test, 1-sided||"The major complication free rate (i.e. survival probability) was estimated using the Kaplan-Meier method.~The coverage level for the confidence interval was 98.66%, determined by the pre-specified alpha spending function for the interim analysis."|"Null hypothesis: Major complication free rate at 6 months post-implant is less than or equal to 83%.~Alternative hypothesis: Major complication free rate at 6 months post-implant is greater than 83%."|
1635599|NCT02004847|3005078|Superiority or Other|||||||0.102|||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 16 of the target plaque compared to the control plaque.|
1635600|NCT02004847|3005078|Superiority or Other|||||||0.0064|||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 12 of the target plaque compared to the control plaque.|
1635601|NCT02004847|3005078|Superiority or Other|||||||0.014|||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to week 4 of the target plaque compared to the control plaque.|
1635602|NCT02004847|3005079|Superiority or Other|||||||0.3075|||||||t-test, 2 sided|||Statistically analysed were the difference in change from end of treatment (week 12, visit 7) to end of follow up (week 16, visit 8) of the target plaque compared to the control plaque.|
1635603|NCT02004847|3005080|Superiority or Other|||||||0.0036|||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to the end of treatment during the attack period (week 4) of the target plaque compared to the control plaque.|
1635604|NCT02004847|3005081|Superiority or Other|||||||0.0005|||||||t-test, 2 sided|||Statistically analysed were the difference in change from baseline to the end of treatment (week 12) of the target plaque compared to the control plaque.|
1635605|NCT02004093|3005132|Superiority or Other||Hazard Ratio (HR)|1.02||||0.9262|2-Sided|80.0|0.74|1.41||p-value resulting from Wald test of null hypothesis that the hazard ratio=1|Wald test||||
1635606|NCT02004093|3005132|Superiority or Other|||||||0.8591|||||||Wilcoxon (Mann-Whitney)||||
1635607|NCT02004093|3005132|Superiority or Other|||||||0.9261|||||||Log Rank||||
1635608|NCT02004093|3005134|Superiority or Other||Hazard Ratio (HR)|1.11||||0.587|2-Sided|80.0|0.87|1.43|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1|||
1635609|NCT02004093|3005134|Superiority or Other|||||||0.3903|||||||Wilcoxon (Mann-Whitney)||||
1635610|NCT02004093|3005134|Superiority or Other|||||||0.5726|||||||Log Rank||||
1635611|NCT02004093|3005137|Superiority or Other||Hazard Ratio (HR)|1.04||||0.8137|2-Sided|80.0|0.82|1.32|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1|||
1635612|NCT02004093|3005137|Superiority or Other|||||||0.692|||||||Wilcoxon (Mann-Whitney)||||
1635613|NCT02004093|3005137|Superiority or Other|||||||0.8129|||||||Log Rank||||
1635614|NCT02004093|3005140|Superiority or Other||Hazard Ratio (HR)|1.22||||0.3679|2-Sided|80.0|0.92|1.61|||Wald test|p-value resulting from Wald test of null hypothesis that the hazard ratio=1|||
1635615|NCT02004093|3005140|Superiority or Other|||||||0.1319|||||||Wilcoxon (Mann-Whitney)||||
1635616|NCT02004093|3005140|Superiority or Other|||||||0.3655|||||||Log Rank||||
1635617|NCT02004093|3005141|Superiority or Other||Odds Ratio (OR)|1.36|||||2-Sided|80.0|0.86|2.17|||||approximate 80% confidence interval (CI) for difference of two rates using Hauck-Anderson method||
1635618|NCT02004093|3005141|Superiority or Other||Difference in Response Rates|6.32||||0.3943|2-Sided|80.0|-3.9|16.6|||Chi-squared||||
1635619|NCT02004093|3005142|Superiority or Other||Hazard Ratio (HR)|1.17||||0.3972|2-Sided|80.0|0.92|1.49||p-value resulting from Wald test of null hypothesis that the hazard ratio equals (=) 1|Wald test||||
1635620|NCT02004093|3005142|Superiority or Other|||||||0.4552|||||||Wilcoxon (Mann-Whitney)||||
1635621|NCT02004093|3005142|Superiority or Other|||||||0.3967|||||||Log Rank||||
1635622|NCT02003963|3005150|Superiority|||||||0.05|||||||ANCOVA||||
1635623|NCT02003924|3005190|Superiority||Difference in Response Rate|9.65|||<|0.0001|2-Sided|95.0|7.75|11.54||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (<6 months, >= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.|Cochran-Mantel-Haenszel|||Decrease to Undetectable Level|
1635624|NCT02003924|3005190|Superiority||Difference in Response Rate|55.52|||<|0.0001|2-Sided|95.0|52.28|58.76||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (<6 months, >= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS|Cochran-Mantel-Haenszel|||Decrease from Baseline >= 90%|
1635625|NCT02003924|3005190|Superiority||Difference in Response Rate|73.96|||<|0.0001|2-Sided|95.0|70.91|77.02||P-value was based on a Cochran-Mantel-Haenszel mean score test stratified by PSA doubling time (<6 months, >= 6 months) and prior concurrent use of a bone targeting agent (yes, no) as per IXRS.|Cochran-Mantel-Haenszel|||Decrease from Baseline >= 50%|
1635626|NCT02003924|3005193|Superiority||Hazard Ratio (HR)|0.378|||<|0.0001|2-Sided|95.0|0.282|0.507||P-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.||
1635627|NCT02003924|3005194|Superiority||Hazard Ratio (HR)|0.959||||0.6534|2-Sided|95.0|0.801|1.149||P-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.||
1635656|NCT02002091|3005301|Superiority or Other|||||||0.008||||||Statistical significance : p< 0.05|Fisher Exact||||
1635657|NCT02002091|3005302|Superiority or Other|||||||0.816|||||||Chi-squared, Corrected||||
1635658|NCT02002091|3005303|Superiority or Other|||||||0.917|||||||Chi-squared, Corrected||||
1635659|NCT02002091|3005305|Superiority or Other|||||||0.038|||||||Fisher Exact||||
1635660|NCT02002091|3005306|Superiority or Other|||||||0.988|||||||Fisher Exact||||
1635628|NCT02003924|3005195|Superiority||Hazard Ratio (HR)|0.795||||0.1519|2-Sided|95.0|0.58|1.089||P-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.|To maintain family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. OS tested at 0.05 only if both time to PSA progression and time to first use of new antineoplastic therapy were significant. If either of them failed to show significance,OS was tested at 0.03.|
1635629|NCT02003924|3005196|Superiority||Hazard Ratio (HR)|0.208|||<|0.0001|2-Sided|95.0|0.168|0.258||P-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.|To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the previous endpoint was statistically significant.|
1635630|NCT02003924|3005197|Superiority||Hazard Ratio (HR)|0.066|||<|0.0001|2-Sided|95.0|0.054|0.081||P-value was based on a stratified log-rank test by PSA doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per IXRS. Threshold for significance at 0.02 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.|To maintain the family-wise 2-sided type I error rate at 0.05, a parallel testing strategy between OS (with allocated type I error rate 0.03) and remaining key secondary endpoints (time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02) was performed. Testing was performed only if the primary endpoint was statistically significant.|
1635631|NCT02003924|3005198|Superiority||Hazard Ratio (HR)|0.292|||<|0.0001|2-Sided|95.0|0.241|0.352||P-value was based on stratified log-rank test by prostate-specific antigen (PSA) doubling time (< 6 months, >= 6 months) and prior or concurrent use of a bone targeting agent (yes, no). Threshold for significance at 0.05 level.|Log Rank||HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with < 1 favoring Enzalutamide.||
1635632|NCT02003898|3005202|Non-Inferiority|non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided).|Mean Difference (Net)|0.034|||||2-Sided|95.0|-0.03|0.098|||||||
1635633|NCT02003391|3005218|Superiority or Other||Mean Difference (Final Values)|-4.6191|||<|0.0001|1-Sided|95.0||-3.8503|||ANCOVA||||
1635634|NCT02003183|3005222|Superiority||Mean Difference (Final Values)|0.09|Standard Deviation|0.1|<|0.02|2-Sided||||||Wilcoxon (Mann-Whitney)|||This analysis applies to the Amygdala.|
1635635|NCT02002871|3005261|Superiority or Other|||||||0.0152|||||||t-test, 2 sided|||The statistical analysis was performed on the difference of the change from baseline of the Blue light treated plaque versus the Control plaque.|
1635636|NCT02002832|3005263|Non-Inferiority or Equivalence (legacy)|LS mean for the treatment difference(lurasidone-risperidone) at week 6 and its 95% confidence interval was presented based on the MMRM. Non-inferiority for lurasidone relative to risperidone was evaluated by comparing the upper bound of the 95% confidence interval to the non-inferiority margin of 7.0. Plots of estimates for change from baseline in PANSS total score based on MMRM over time (Week 1 to Week 6) with 95% confidence intervals was provided for each treatment group.|Mean Difference (Final Values)|3.7|Standard Error of the Mean|1.37|||2-Sided|95.0|1.0|6.3|||||||
1635637|NCT02002533|3005279|Superiority||Mean Difference (Final Values)|0.911|Standard Error of the Mean|0.4||0.027|2-Sided||||||ANCOVA||This is an arm by baseline interaction parameter.||
1635638|NCT02002533|3005279|Superiority||Mean Difference (Final Values)|3.75|Standard Error of the Mean|2.326||0.114|2-Sided||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.||
1635639|NCT02002533|3005279|Superiority||Mean Difference (Final Values)|-1.723|Standard Error of the Mean|1.007||0.094|2-Sided||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.||
1635640|NCT02002533|3005279|Superiority||Mean Difference (Final Values)|-6.502|Standard Error of the Mean|2.558||0.015|2-Sided||||||ANCOVA||Group difference (BBT - HEAL) in mean post-pre change.||
1635641|NCT02002533|3005280|Superiority|||||||0.573|||||||ANCOVA||||
1635642|NCT02002533|3005281|Superiority|||||||0.295|||||||ANCOVA||||
1635643|NCT02002533|3005282|Superiority|||||||0|||||||ANCOVA||||
1635644|NCT02002533|3005283|Superiority||Mean Difference (Final Values)|-6.24|Standard Error of the Mean|0.221||0.007|2-Sided|||||Grouped by baseline interaction.|ANCOVA||The estimated value is grouped by baseline interaction parameter.||
1635645|NCT02002533|3005283|Superiority||Mean Difference (Final Values)|-0.032|Standard Error of the Mean|0.053||0.556|2-Sided|||||At baseline of 1.5.|ANCOVA||||
1635646|NCT02002533|3005283|Superiority||Mean Difference (Final Values)|0.077|Standard Error of the Mean|0.045||0.092|2-Sided|||||At baseline 1.3.|ANCOVA||||
1635647|NCT02002533|3005283|Superiority||Mean Difference (Final Values)|0.404|Standard Error of the Mean|0.137||0.005|2-Sided||||||ANCOVA|For baseline of 0.7.|||
1635648|NCT02002533|3005284|Superiority||Mean Difference (Final Values)|-1.08|Standard Error of the Mean|0.73||0.14|2-Sided||||||ANCOVA||Estimated value is BBT minus HEAL.||
1635649|NCT02002533|3005285|Superiority||Mean Difference (Final Values)|-1.64|Standard Error of the Mean|1.21||0.1808|2-Sided||||||ANCOVA||The estimated value is BBT minus HEAL.||
1635650|NCT02002533|3005286|Superiority||Mean Difference (Final Values)|0.8075|Standard Error of the Mean|0.0845|<|0.0001|2-Sided||||||Mixed Models Analysis||||
1635651|NCT02002533|3005287|Superiority|||||||0.735|||||||exact binomial test||||
1635652|NCT02002533|3005288|Superiority||||||>|0.9999|||||||exact binomial test|The percentage is greater than or equal to 40%.|||
1635696|NCT01999920|3005522|Superiority|||||||0.064|||||||Mixed Models Analysis||||
1635661|NCT02002091|3005307|Superiority or Other|||||||0.004||||||The threshold for statistical significance for P-Value is <0.05|Fisher Exact||||
1635662|NCT02002091|3005308|Other|||||||0.968|||||||Chi-squared, Corrected||||
1635663|NCT02002091|3005309|Other|||||||0.123|||||||Mantel Haenszel||||
1635664|NCT02002091|3005310|Other|||||||0.346|||||||Chi-squared||||
1635665|NCT02002091|3005311|Other|||||||0.706|||||||Chi-squared||||
1635666|NCT02001688|3005367|Superiority||||||<|0.0001|||||||Kruskal-Wallis|p-value of Kruskal-Wallis test (3 groups: Kamada-AAT for Inhalation, 80mg, Kamada-AAT for Inhalation, 160mg and placebo)|||
1635667|NCT02001688|3005368|Superiority||||||<|0.0001|||||||Kruskal-Wallis|p-value of Kruskal-Wallis test (3 groups: Kamada-AAT for Inhalation, 80mg,Kamada-AAT for Inhalation, 160mg and placebo)|||
1635668|NCT02001688|3005369|Superiority|||||||0.2485|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|||
1635669|NCT02001688|3005369|Superiority|||||||0.0193|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|||
1635670|NCT02001688|3005369|Superiority|||||||0.0005||||||One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|Wilcoxon (Mann-Whitney)|p-value of Stratified Wilcoxon test|||
1635671|NCT02001688|3005370|Superiority|||||||0.0192|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|||
1635672|NCT02001688|3005370|Superiority|||||||0.02|||||||Wilcoxon (Mann-Whitney)|One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|||
1635673|NCT02001688|3005370|Superiority|||||||0.0005||||||One-sided test was used for antigenic and functional AAT levels to maintain overall 2.5% level of significance|Wilcoxon (Mann-Whitney)||||
1635674|NCT02001181|3005391|Superiority or Other||Mean Difference (Final Values)|-51.8|Standard Error of the Mean|8.48|<|0.0001|2-Sided|80.0|-62.8|-40.8|||Mixed Models Analysis|The mixed model for repeated measures analysis included all the participants in FAS.|||
1635675|NCT02000752|3005431|Superiority or Other||Mean Difference (Final Values)|2.84||||0.2|1-Sided|95.0|0.84||||t-test, 2 sided||||
1635676|NCT02000752|3005432|Superiority or Other||difference in percentages|2.13||||0.16|1-Sided|95.0|1.01||||t-test, 1 sided||||
1635677|NCT02000752|3005433|Superiority or Other||difference in percentage|0.0||||1|2-Sided|95.0|||||t-test, 2 sided||||
1635678|NCT02000752|3005434|Superiority or Other||Mean Difference (Final Values)|9.98|||<|0.001|1-Sided|95.0|7.59||||t-test, 1 sided||||
1635679|NCT02000622|3005435|Superiority||Hazard Ratio (HR)|0.53||||0.0002|2-Sided|95.0|0.38|0.74|||Log Rank|Stratified by recieved prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio <1 favours olaparib.|Supportive analysis to PFS2.|
1635680|NCT02000622|3005436|Superiority||Hazard Ratio (HR)|0.34|||<|0.0001|2-Sided|95.0|0.24|0.47|||Log Rank|Stratified by recieved prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio <1 favours olaparib.|Supportive analysis to PFS.|
1635681|NCT02000622|3005437|Superiority||Hazard Ratio (HR)|0.57||||0.0005|2-Sided|95.0|0.41|0.78|||Log Rank|Stratified by recieved prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio <1 favours olaparib.||
1635682|NCT02000622|3005438|Superiority||Mean Difference (Final Values)|7.5||||0.0035|2-Sided|95.0|2.5|12.4|||Mixed Models Analysis|Variables for treatment, visit, treatment-visit interaction, adjusted for baseline global health status/QoL score, baseline score-visit interaction.|Mean difference >0 favours olaparib.||
1635683|NCT02000622|3005440|Superiority||Hazard Ratio (HR)|0.9||||0.5665|2-Sided|95.0|0.63|1.29||OS tested using a multiple testing procedure with a recycling strategy. With 140 OS events, a priori threshold for statistical significance (2-sided) was 0.018.|Log Rank|Stratified by recieved prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio <1 favours olaparib.||
1635684|NCT02000622|3005441|Superiority||Hazard Ratio (HR)|0.57||||0.0033|2-Sided|95.0|0.4|0.83||PFS2 tested using a multiple testing procedure with a recycling strategy. With 157 PFS2 events, a priori threshold for statistical significance (2-sided) was 0.008.|Log Rank|Stratified by recieved prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio <1 favours olaparib.||
1635685|NCT02000622|3005442|Superiority||Hazard Ratio (HR)|0.58||||0.0009|2-Sided|95.0|0.43|0.8||A priori threshold for statistical significance (2-sided) is 0.05.|Log Rank|Stratified by recieved prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.|Hazard ratio <1 favours olaparib.|Study is sized to provide 90% power to detect a true treatment effect of PFS hazard ratio 0.653.|
1635686|NCT02000531|3005444|Superiority or Other||Hazard Ratio (HR)|1.26|||>|0.05|2-Sided|95.0|0.61|2.62|||Log Rank||||
1635687|NCT01999920|3005517|Superiority||Standard error|21.38|Standard Error of the Mean|7.65||0.01|2-Sided|95.0|5.64|37.11|||Mixed Models Analysis||||
1635688|NCT01999920|3005518|Superiority||Standard error|3.29|Standard Error of the Mean|1.43||0.026|2-Sided|95.0|0.42|6.16|||Mixed Models Analysis||||
1635689|NCT01999920|3005519|Superiority||Standard error|-19.91|Standard Error of the Mean|6.99||0.008|2-Sided|95.0|-34.23|-5.58|||Mixed Models Analysis||||
1635690|NCT01999920|3005520|Superiority||Standard error|0.71|Standard Error of the Mean|2.82||0.8|2-Sided|95.0|-5.3|6.72|||Mixed Models Analysis|||Preoccupation with Relationships variable|
1635691|NCT01999920|3005520|Superiority||Standard error|-2.6|Standard Error of the Mean|1.49||0.1|2-Sided|95.0|-5.79|0.58|||Mixed Models Analysis|||Need for Approval variable|
1635692|NCT01999920|3005520|Superiority||Standard error|3.94|Standard Error of the Mean|3.79||0.31|2-Sided|95.0|-4.12|12.01|||Mixed Models Analysis|||Relationships as Secondary variable|
1635693|NCT01999920|3005520|Superiority||Standard error|1.18|Standard Error of the Mean|4.41||0.79|2-Sided|95.0|-8.21|10.58|||Mixed Models Analysis|||Discomfort with Closeness variable|
1635694|NCT01999920|3005520|Superiority||Standard error|0.34|Standard Error of the Mean|2.44||0.89|2-Sided|95.0|-4.85|5.53|||Mixed Models Analysis|||Confidence variable|
1635695|NCT01999920|3005521|Superiority||Standard error|5.5|Standard Error of the Mean|3.13||0.11|2-Sided|95.0|-1.32|12.32|||Mixed Models Analysis||||
1635697|NCT01999868|3005528|Superiority|||||||0.045||||||Two-sided test.|ANCOVA|Randomization (PASI score week 0:12-20 or >20), DLQI score at baseline, duration of disease prior to screening, centered about median, are covariates||Week 12 to 88|
1635698|NCT01999868|3005528|Superiority|||||||0.18||||||Two-sided test.|ANCOVA|Randomization stratum (PASI score at week 0: 12-20 or >20), baseline DLQI, and pre-screening disease duration, centered on the median, are covariates.||Week 12 to 40|
1635699|NCT01999868|3005529|Superiority|||||||0.95|||||||Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 88|
1635700|NCT01999868|3005529|Superiority|||||||0.013||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40|
1635701|NCT01999868|3005530|Superiority|||||||0.001||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.|
1635702|NCT01999868|3005530|Superiority|||||||0.005||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.|
1635703|NCT01999868|3005531|Superiority|||||||0.008||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.|
1635704|NCT01999868|3005531|Superiority|||||||0.06||||||Two-sided test.|Grouped survival analysis|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.|
1635705|NCT01999868|3005532|Superiority|||||||0.43||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.|
1635706|NCT01999868|3005532|Superiority|||||||0.23||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.|
1635707|NCT01999868|3005532|Superiority|||||||0.002||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.|
1635708|NCT01999868|3005532|Superiority|||||||0.16||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.|
1635709|NCT01999868|3005533|Superiority|||||||0.07||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.|
1635710|NCT01999868|3005533|Superiority|||||||0.018||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.|
1635711|NCT01999868|3005533|Superiority|||||||0.001||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.|
1635712|NCT01999868|3005533|Superiority|||||||0.019||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study.|
1635713|NCT01999868|3005534|Superiority|||||||0.67||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 40 to 88. This interval corresponds to the time from the beginning of the blinded observation phase until the end of the study.|
1635714|NCT01999868|3005534|Superiority|||||||0.5||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 28 to 88. This interval corresponds to the time from the last scheduled dose of ustekinumab or ustekinumab placebo until the end of the study.|
1635715|NCT01999868|3005534|Superiority|||||||0.013||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 40. This interval corresponds to the time from randomization until the end of the blinded treatment phase.|
1635716|NCT01999868|3005534|Superiority|||||||0.41||||||Two-sided test.|Regression, Logistic|Randomization stratum (PASI score at week 0: 12-20 or >20) and duration of disease prior to screening, centered about the median, are covariates.||Week 12 to 88. This interval corresponds to the time from randomization until the end of the study. This analysis is the primary analysis of the primary endpoint.|
1635717|NCT01999777|3005535|Superiority|||||||0.1388|||||||Log Rank||||
1635767|NCT01998269|3005697|Superiority or Other||correlation coefficient|0.6|||<|0.001|2-Sided||||||Correlation||r= 0.60, p-value<0.001. P values below 0.05 are considered statistically significant in this study.|We examined correlations between patient scores on the Measure of Medication Self-Management (MeDS) and the 8-item Morisky Medication Adherence questionnaire.|
1635718|NCT01999777|3005536|Superiority|||||||0.1972|||||||Wald asymptotic|P-value based on a standard Wald asymptotic test for equality without a continuity correction.||Assumptions included that the proportion of seizures occurring within 6 hours after placebo administration was ~65% and a relative reduction of 50% would result in a reduction of ≥ 32.5 percentage points. Based on a 2-sided 95% confidence interval (CI) for the differences in proportions, a sample size of 62 analyzable subjects was chosen to detect a 0.35 difference between group. Sample size estimations were based on nQuery Version 7.0 using the table for CIs for differences in 2 proportions.|
1635719|NCT01999465|3005541|Other|||||||0.2|||||||t-test, 2 sided||||
1635720|NCT01999465|3005542|Other|||||||0.4|||||||Wilcoxon (Mann-Whitney)|We applied Wilcoxon-Mann Whitney test with the Null hypothesis that there is no difference between 2 arms.|||
1635721|NCT01999218|3005564|Other||Difference in the LSM vs. Glimepiride|-3.2|||<|0.001|2-Sided|0.001|-4.73|-1.67|||Constrained Logitudinal Data Analysis||||Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).
1635722|NCT01999218|3005564|Other||Difference in the LSM vs. Glimepiride|-4.77|||<|0.001|2-Sided|95.0|-6.29|-3.25|||Constrained Logitudinal Data Analysis||||Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).
1635723|NCT01999218|3005565|Other||Difference in the LSM vs. Glimepiride|-3.87|||<|0.001|2-Sided|95.0|-4.36|-3.38|||Constrained Longitudinal Data Analysis||||Constrained Longitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).
1635724|NCT01999218|3005565|Other||Difference in LSM vs. Glimepiride|-4.29|||<|0.001|2-Sided|95.0|-4.77|-3.8|||Constrained Longitudinal Data analysis||LSM=Least Squares Means||Constrained Longitudinal Data analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).
1635725|NCT01999218|3005566|Other||Difference in % vs. Glimepiride|-16.1|||<|0.001|2-Sided|95.0|-20.3|-12.2|||Based on Miettinen & Nurminen method||||Based on Miettinen & Nurminen method
1635726|NCT01999218|3005566|Other||Difference in % vs. Glimepiride|-14.0|||<|0.001|2-Sided|95.0|-18.4|-9.8|||Based on Miettinen & Nurminen method||||Based on Miettinen & Nurminen method
1635727|NCT01999218|3005567|Other||Difference in % vs. Glimepiride|1.5|||||2-Sided|95.0|-1.7|4.7|||||||
1635728|NCT01999218|3005567|Other||Difference in % vs. Glimepiride|3.0|||||2-Sided|95.0|-0.3|6.4|||||||
1635729|NCT01999218|3005568|Other|Based on Miettinen & Nurminen method|Difference in % vs. Glimepiride|0.5|||||2-Sided|95.0|-5.6|6.5|||||||
1635730|NCT01999218|3005568|Other|Based on Miettinen & Nurminen method|Difference in % vs. Glimepiride|1.6|||||2-Sided|95.0|-4.5|7.7|||||||
1635731|NCT01999218|3005569|Non-Inferiority|Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.|Difference in the Least Squares means|0.18|||||2-Sided|95.0|0.06|0.3|||||"Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.~Time was treated as a categorical variable."||
1635732|NCT01999218|3005569|Non-Inferiority|Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.|Difference in the Least Squares Means|0.1|||||2-Sided|95.0|-0.02|0.22|||||Constrained Longitudinal Data Analysis (cLDA) model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.||
1635733|NCT01998984|3005596|Superiority||Relative risk|1.2||||0.28|2-Sided|95.0|0.86|1.65||Adjusted for analysis site. Relative risk of partial clearance relative to 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.|
1635734|NCT01998984|3005596|Superiority||Relative risk|25.2||||0.002|2-Sided|95.0|3.39|187.4||Adjusted for analysis site. Relative risk of partial clearance relative to vehicle group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.|
1635735|NCT01998984|3005596|Superiority||Relative risk|32.26|||<|0.001|2-Sided|95.0|4.39|236.8||P value adjusted for analysis site.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site and were Mantel-Haenszel estimators. Relative risk of partial clearance relative to vehicle group.|The treatment comparison was based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.|
1635736|NCT01998984|3005597|Superiority||Ratio of adjusted mean|0.89||||0.36|2-Sided|95.0|0.7|1.14||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.||
1635737|NCT01998984|3005597|Superiority||Ratio of adjusted mean|0.36|||<|0.001|2-Sided|95.0|0.29|0.45||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.||
1635768|NCT01998243|3005698|Superiority|||||||0.673|||||||Fisher Exact||||
1635769|NCT01998243|3005699|Superiority|||||||1|||||||Fisher Exact||||
1635770|NCT01998243|3005700|Superiority|||||||0.937|||||||Wilcoxon (Mann-Whitney)||||
1635738|NCT01998984|3005597|Superiority||Ratio of adjusted mean|0.4|||<|0.001|2-Sided|95.0|0.32|0.51||P-value was from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.|Negative binomial regression||Estimation parameter and confidence interval were from negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset with 1000 Imputations.||
1635739|NCT01998984|3005598|Superiority||Relative risk|0.47||||0.25|2-Sided|95.0|0.13|1.68||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Mantel Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Type I error not controlled. Mantel-Haenszel estimators were used."|
1635740|NCT01998984|3005598|Superiority||Relative risk|3.51||||0.051|2-Sided|95.0|1.0|12.41||P-value was adjusted for analysis site using Rubin's pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared subject in the vehicle group.~Type I error not controlled."|
1635741|NCT01998984|3005598|Superiority||Relative risk|2.97||||0.18|2-Sided|95.0|0.6|14.74||P-value was adjusted for analysis site using Rubin’s pooling methodology after log transformation of RR (relative risk) of each imputation. Complete clearance relative to vehicle group and 2-day group.|Cochran-Mantel-Haenszel||Relative risk and confidence interval were adjusted for analysis site using Rubin's pooling methodology after log transformation of RR of each imputation. Complete clearance relative to vehicle group and 2-day group.|"Treatment comparison based on 1000 imputations of AK count at week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline AK count as offset.~Cochran-Mantel-Haenszel logit estimators were used for comparisons with vehicle due to absence of cleared participant in the vehicle group."|
1635742|NCT01998919|3005615|Superiority or Other||Hazard Ratio (HR)|0.84||||0.3774|2-Sided|95.0|0.58|1.23|||Wald test||||
1635743|NCT01998919|3005615|Superiority or Other|||||||0.5991|||||||Log Rank||||
1635744|NCT01998919|3005616|Superiority or Other||Hazard Ratio (HR)|0.47|||<|0.0001|2-Sided|95.0|0.33|0.68|||Wald test||||
1635745|NCT01998919|3005616|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1635746|NCT01998919|3005617|Superiority or Other||Hazard Ratio (HR)|0.48||||0.0001|2-Sided|95.0|0.33|0.7|||Wald Test||||
1635747|NCT01998919|3005617|Superiority or Other|||||||0.0004|||||||Log Rank||||
1635748|NCT01998919|3005618|Superiority or Other||Hazard Ratio (HR)|0.42||||0.0099|2-Sided|95.0|0.22|0.81|||Wald test||||
1635749|NCT01998919|3005618|Superiority or Other|||||||0.0075|||||||Log Rank||||
1635750|NCT01998919|3005619|Superiority or Other||Mean Difference (Final Values)|12.48|||||2-Sided|95.0|-2.7|27.7|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.||
1635751|NCT01998919|3005620|Superiority or Other||Mean Difference (Final Values)|10.63|||||2-Sided|95.0|-5.6|26.8|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.||
1635752|NCT01998919|3005621|Superiority or Other||Mean Difference (Final Values)|3.34|||||2-Sided|95.0|-10.3|17.0|||||Approximate 95% CI for difference of two rates using Hauck-Anderson method.||
1635753|NCT01998906|3005627|Superiority or Other||Hazard Ratio (HR)|0.59||||0.0555|2-Sided|95.0|0.35|1.02|||Log Rank||||
1635754|NCT01998906|3005629|Superiority or Other||Hazard Ratio (HR)|0.65||||0.0275|2-Sided|95.0|0.44|0.96|||Log Rank||||
1635755|NCT01998906|3005631|Superiority or Other||Mean Difference (Final Values)|6.4||||0.3077|2-Sided|95.0|-6.4|19.1|||Chi-squared||||
1635756|NCT01998906|3005632|Superiority or Other||Mean Difference (Final Values)|19.3||||0.0014|2-Sided|95.0|7.2|31.4|||Chi-squared||||
1635757|NCT01998906|3005633|Superiority or Other||Mean Difference (Final Values)|17.6||||0.0051|2-Sided|95.0|5.0|30.2|||Chi-squared||||
1635758|NCT01998880|3005642|Superiority||Difference in Response Rates|33.04|||<|0.0001|2-Sided|95.0|22.1|43.9|||Chi-squared|||Includes subjects with best overall response: CR, CRi, PR or nPR.|
1635759|NCT01998880|3005643|Superiority or Other||Hazard Ratio (stratified)|0.45|||<|0.0001|2-Sided|95.0|0.31|0.65|||Log Rank, Stratified||Stratified by Binet stage at Baseline.||
1635760|NCT01998880|3005644|Superiority or Other||Hazard Ratio (stratified)|0.4|||<|0.0001|2-Sided|95.0|0.3|0.53|||Log Rank, Stratified||Stratified by Binet stage at Baseline.||
1635761|NCT01998880|3005648|Superiority or Other||Hazard Ratio (HR)|0.46|||<|0.0001|2-Sided|95.0|0.35|0.61|||Log-ranked, Stratified||Stratified by Binet stage at Baseline.||
1635762|NCT01998880|3005650|Superiority or Other||Mean Difference (Final Values)|34.31|||<|0.0001|2-Sided|95.0|23.5|45.1|||Chi-squared||||
1635763|NCT01998880|3005651|Superiority or Other||Hazard Ratio (HR)|0.84||||0.2841|2-Sided|95.0|0.61|1.16|||Log Rank, Stratified||Stratified by Binet stage at Baseline.||
1635764|NCT01998880|3005652|Superiority or Other||Hazard Ratio (HR)|0.39|||<|0.0001|2-Sided|95.0|0.31|0.5|||Log Rank, Stratified||Stratified by Binet stage at Baseline.||
1635765|NCT01998880|3005654|Superiority or Other||Hazard Ratio (HR)|0.46|||<|0.0001|2-Sided|95.0|0.36|0.59||Type I error controlled through closed test procedure.|Log Rank, Stratified||Stratified by Binet stage at Baseline.||
1635766|NCT01998399|3005691|Superiority or Other|||||||0.41|||||||Chi-squared|||Total enrollment only 25 patients and the study was terminated early due to low enrollment. No further statistical analysis was done.|
1635771|NCT01998243|3005701|Superiority||Risk Ratio (RR)|1.59||||0.144|2-Sided|95.0|0.84|3.01|||Chi-squared||all in all balloon and postsurgical morbidity in group A vs. group B.||
1635772|NCT01998243|3005702|Superiority||Risk Ratio (RR)|1.2||||0.689|2-Sided|95.0|0.53|2.6|||Chi-squared||risk ratio (RR)||
1635773|NCT01997398|3005744|Superiority or Other||||||<|0.001||||||Differences in baseline and 6-month postoperative scores were assessed using a series of repeated measures general linear models with a single within-subjects factor and no between-subjects factors.|Repeated measures general linear models||||
1635774|NCT01997333|3005747|Superiority|||||||0.726|||||||Log Rank|Stratified log rank.|||
1635775|NCT01997333|3005749|Superiority|||||||0.264|||||||Cochran-Mantel-Haenszel|Adjusted for stratification factors.|||
1635776|NCT01997333|3005750|Superiority|||||||0.761|||||||Log Rank|Stratified log rank test.|||
1635777|NCT01997229|3005751|Superiority||Mean Difference (Net)|-11.7||||0.0698|2-Sided|95.0|-24.33|0.96|||ANCOVA||||
1635778|NCT01996813|3005788|Superiority||Mean Difference (Final Values)|40.31|||<|0.001|2-Sided|95.0|20.22|60.39|||t-test, 2 sided|A Satterthwaite correction was used to adjust the degrees of freedom||The null hypothesis is that there is no difference in the average length of surgery between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position|
1635779|NCT01996813|3005789|Superiority||Odds Ratio (OR)|0.115||||0.0553|2-Sided|95.0|0.002|1.034||The exact p-value was estimated|Regression, Logistic|The method was exact logistic regression||The null hypothesis is that there is no difference in the odds of a cerebral desaturation event between patients wearing versus not wearing thigh-high compression stockings during shoulder arthroscopy in the beach chair position|
1635780|NCT01996644|3005802|Superiority or Other|||||||0.043|||||||ANOVA||||
1635781|NCT01996592|3005804|Other||||||<|0.01||||||p-value was calculated|ANOVA||||
1635782|NCT01996592|3005805|Other||||||<|0.01||||||p-value was calculated|ANOVA|||"PROMIS -perceived stress scale was utilized (a validated test). Scoring ranges from 0-40, with the following ranges indicative of low, moderate, or high perceived stress:~0-13=low stress 14-26=moderate stress 27-40=high perceived stress"|
1635783|NCT01996319|3005816|Superiority or Other||Null hypoth|36.7126||||0.0399|2-Sided|95.0|1.7241|71.7011|||ANCOVA||||
1635784|NCT01996319|3005817|Superiority or Other||null hypoth|0.2021|||<|0.0001|2-Sided|95.0|0.1583|0.246|||ANCOVA||||
1635785|NCT01996241|3005828|Other||Odds Ratio (OR)|0.83||||0.45|2-Sided|95.0|0.5|1.34||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects|||
1635786|NCT01996241|3005829|Other||Odds Ratio (OR)|1.05||||0.79|2-Sided|95.0|0.7|1.55||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects|||
1635787|NCT01996241|3005830|Other||Odds Ratio (OR)|0.83||||0.26|2-Sided|95.0|0.6|1.15||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects|||
1635788|NCT01996241|3005831|Other||Odds Ratio (OR)|1.32||||0.331|2-Sided|95.0|0.2|2.31||Adjusted for village strata and cluster, village type, caste, household literacy status, stratum using individual-level data and poor learning environment at school, school dropout, and marriage (in the form of cluster-level summaries).|Regression, Logistic|Mixed-effects|||
1635789|NCT01996241|3005832|Other||Odds Ratio (OR)|1.0||||0.98|2-Sided|95.0|0.7|1.4||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects|||
1635790|NCT01996241|3005833|Other|Odds ratio (95% CI), p-value for all the outcomes.|Odds Ratio (OR)|1.01||||0.98|2-Sided|95.0|0.7|1.38||Adjusted models controlled for cluster, village strata, village type, caste, household literacy status, stratum (individual-level data endline) and poor learning environment at school, school dropout, and marriage (cluster-level summaries baseline)|Regression, Logistic|Mixed-effects|||
1635791|NCT01995838|3005848|Superiority||LS Mean Difference|0.94||||0.6148|2-Sided|95.0|-2.74|4.63|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17|
1635792|NCT01995838|3005848|Superiority||LS Mean Difference|2.41||||0.1794|2-Sided|95.0|-1.11|5.93|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17|
1635793|NCT01995838|3005848|Superiority||LS Mean Difference|-2.39||||0.253|2-Sided|95.0|-6.51|1.72|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17|
1635794|NCT01995838|3005848|Superiority||LS Mean Difference|1.5||||0.4548|2-Sided|95.0|-2.44|5.44|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17|
1635795|NCT01995838|3005848|Superiority||LS Mean Difference|-0.64||||0.772|2-Sided|95.0|-4.96|3.69|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17|
1635796|NCT01995838|3005848|Superiority||LS Mean Difference|-3.05||||0.1483|2-Sided|95.0|-7.2|1.09|||ANCOVA|Baseline value and treatment as covariates.||Days 16-17|
1635797|NCT01995838|3005852|Superiority||LS Mean Difference|-21.52||||0.002|2-Sided|95.0|-35.12|-7.91|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635798|NCT01995838|3005852|Superiority||LS Mean Difference|-20.8||||0.0019|2-Sided|95.0|-33.86|-7.74|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635799|NCT01995838|3005852|Superiority||LS Mean Difference|-14.73||||0.0581|2-Sided|95.0|-29.97|0.51|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635800|NCT01995838|3005852|Superiority||LS Mean Difference|-10.69||||0.1461|2-Sided|95.0|-25.14|3.75|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635801|NCT01995838|3005852|Superiority|Baseline value and treatment as covariates.|LS Mean Difference|-2.31||||0.7754|2-Sided|95.0|-18.27|13.64|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635802|NCT01995838|3005852|Superiority||LS Mean Difference|0.4642||||0.4642|2-Sided|95.0|-9.6|20.98|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635803|NCT01995838|3005852|Superiority||LS Mean Difference|-25.84|||<|0.0001|2-Sided|95.0|-37.59|-14.09|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635804|NCT01995838|3005852|Superiority||LS Mean Difference|-29.34|||<|0.0001|2-Sided|95.0|-40.75|17.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635805|NCT01995838|3005852|Superiority||LS Mean Difference|-19.81|||<|0.0038|2-Sided|95.0|-33.18|-6.43|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635806|NCT01995838|3005852|Superiority||LS Mean Difference|-11.26|||<|0.0818|2-Sided|95.0|-23.94|1.43|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635807|NCT01995838|3005852|Superiority||LS Mean Difference|-2.29|||<|0.7501|2-Sided|95.0|-16.46|11.87|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635808|NCT01995838|3005852|Superiority||LS Mean Difference|-11.08|||<|0.105|2-Sided|95.0|-24.48|2.33|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635809|NCT01995838|3005853|Superiority||Geometric Mean Ratio|0.34|||<|0.0001|2-Sided|95.0|0.24|0.48|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635810|NCT01995838|3005853|Superiority||Geometric Mean Ratio|0.41|||<|0.0001|2-Sided|95.0|0.29|0.57|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635811|NCT01995838|3005853|Superiority||Geometric Mean Ratio|0.32|||<|0.0001|2-Sided|95.0|0.21|0.47|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635812|NCT01995838|3005853|Superiority||Geometric Mean Ratio|0.47|||<|0.0001|2-Sided|95.0|0.32|0.69|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635813|NCT01995838|3005853|Superiority||Geometric Mean Ratio|0.49|||<|0.001|2-Sided|95.0|0.33|0.75|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635814|NCT01995838|3005853|Superiority||Geometric Mean Ratio|0.73|||<|0.1158|2-Sided|95.0|0.49|1.08|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635815|NCT01995838|3005853|Superiority||Geometric Mean Ratio|0.39|||<|0.0001|2-Sided|95.0|0.29|0.54|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2:|
1635816|NCT01995838|3005853|Superiority||Geometric Mean Ratio|0.52|||<|0.0001|2-Sided|95.0|0.38|0.7|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635817|NCT01995838|3005853|Superiority||Geometric Mean Ratio|0.54|||<|0.0006|2-Sided|95.0|0.38|0.76|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635818|NCT01995838|3005853|Superiority||Geometric Mean Ratio|0.6|||<|0.0025|2-Sided|95.0|0.43|0.83|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635819|NCT01995838|3005853|Superiority|Days 1-2|Geometric Mean Ratio|0.55|||<|0.0018|2-Sided|95.0|0.38|0.8|||ANCOVA|Baseline value and treatment as covariates.|||
1635820|NCT01995838|3005853|Superiority||Geometric Mean Ratio|0.77|||<|0.1407|2-Sided|95.0|0.54|1.09|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635821|NCT01995838|3005854|Superiority||LS Mean Difference|8.87|||<|0.0001|2-Sided|95.0|5.72|12.02|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635822|NCT01995838|3005854|Superiority||LS Mean Difference|7.89|||<|0.0001|2-Sided|95.0|4.86|10.92|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635823|NCT01995838|3005854|Superiority||LS Mean Difference|7.78|||<|0.0001|2-Sided|95.0|4.24|11.32|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635824|NCT01995838|3005854|Superiority||LS Mean Difference|5.76|||<|0.0008|2-Sided|95.0|2.4|9.12|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635825|NCT01995838|3005854|Superiority||LS Mean Difference|3.94|||<|0.038|2-Sided|95.0|0.22|7.66|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635826|NCT01995838|3005854|Superiority||LS Mean Difference|0.34|||<|0.8505|2-Sided|95.0|-3.22|3.9|||ANCOVA|Baseline value and treatment as covariates.||Days 14-15|
1635827|NCT01995838|3005854|Superiority||LS Mean Difference|10.13|||<|0.0001|2-Sided|95.0|7.18|13.08|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635828|NCT01995838|3005854|Superiority||LS Mean Difference|10.06|||<|0.0001|2-Sided|95.0|7.2|12.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635829|NCT01995838|3005854|Superiority||LS Mean Difference|8.09|||<|0.0001|2-Sided|95.0|4.73|11.45|||ANCOVA|||Days 1-2|
1635830|NCT01995838|3005854|Superiority||LS Mean Difference|5.74|||<|0.0005|2-Sided|95.0|2.54|8.93|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635831|NCT01995838|3005854|Superiority||LS Mean Difference|4.44|||<|0.0151|2-Sided|95.0|0.86|8.01|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635832|NCT01995838|3005854|Superiority||LS Mean Difference|4.57|||<|0.0083|2-Sided|95.0|1.19|7.94|||ANCOVA|Baseline value and treatment as covariates.||Days 1-2|
1635833|NCT01995838|3005855|Superiority||LS Mean Difference|0.68||||0.0063|2-Sided|95.0|0.19|1.17|||ANCOVA|Baseline value and treatment as covariates.|||
1635834|NCT01995838|3005855|Superiority||LS Mean Difference|0.38||||0.1071|2-Sided|95.0|-0.08|0.85|||ANCOVA|Baseline value and treatment as covariates.|||
1635835|NCT01995838|3005855|Superiority||LS Mean Difference|0.01||||0.9818|2-Sided|95.0|0.0|0.55|||ANCOVA|Baseline value and treatment as covariates.|||
1635836|NCT01995838|3005855|Superiority||LS Mean Difference|0.43||||0.1059|2-Sided|95.0|-0.09|0.94|||ANCOVA|Baseline value and treatment as covariates.|||
1635837|NCT01995838|3005855|Superiority||LS Mean Difference|0.13||||0.649|2-Sided|95.0|-0.44|0.7|||ANCOVA|Baseline value and treatment as covariates.|||
1635838|NCT01995838|3005855|Superiority||LS Mean Difference|0.51||||0.0651|2-Sided|95.0|-0.03|1.06|||ANCOVA|Baseline value and treatment as covariates.|||
1635839|NCT01995513|3005870|Superiority or Other (legacy)||Hazard Ratio (HR)|1.399||||0.0739|2-Sided|95.0|0.967|2.025||P-value was based on log-rank test stratified by PSA response (>=0% to <30% vs >=30%) at Week 13 in the open-label period|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (>=0% to <30% vs >=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with < 1 favoring Enzalutamide.||
1635840|NCT01995513|3005877|Superiority or Other (legacy)||Hazard Ratio (HR)|0.861||||0.3818|2-Sided|95.0|0.616|1.204||P-value was based on log-rank test stratified by PSA response (>=0% to <30% vs >=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (>=0% to <30% vs >=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with < 1 favoring Enzalutamide.||
1635841|NCT01995513|3005878|Superiority or Other (legacy)||Difference in Progression Rate|9.09||||0.2963|2-Sided|95.0|-7.69|25.87||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (>=0% to <30% vs >=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in Progression Rate was based upon normal approximation.||
1635842|NCT01995513|3005879|Superiority or Other (legacy)||Difference in Objective Response Rate|10.92||||0.3216|2-Sided|95.0|-10.37|32.21||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (>=0% to <30% vs >=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in objective response rate was based upon standard normal approximation.|This analysis is reported for participants with CR+PR+SD.|
1635843|NCT01995513|3005879|Superiority or Other (legacy)||Difference in Objective Response Rate|-5.0||||0.1653|2-Sided|95.0|-11.75|1.75||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (>=0% to <30% vs >=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in objective response rate was based upon standard normal approximation.|This analysis is reported for participants with CR+PR.|
1635844|NCT01995513|3005880|Superiority or Other (legacy)||Difference in Response Rate|-0.04||||0.9917|2-Sided|95.0|-3.9|3.82||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (>=0% to <30% vs >=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in response rate was based upon standard normal approximation.|This analysis is reported for participants with >=30% decrease from baseline in PSA response.|
1635845|NCT01995513|3005880|Superiority or Other (legacy)||Difference in Response Rate|-1.65||||0.3101|2-Sided|95.0|-4.82|-1.51||P-value was based on Cochran-Mantel-Haenszel mean score test stratified by PSA response (>=0% to <30% vs >=30%) at Week 13 in the open-label period.|Cochran-Mantel-Haenszel||Difference in response rate was based upon standard normal approximation.|This analysis is reported for participants with >=50% decrease from baseline in PSA response.|
1635846|NCT01995513|3005881|Superiority or Other (legacy)||Hazard Ratio (HR)|0.874||||0.45|2-Sided|95.0|0.617|1.239||P-value was based on log-rank test stratified by PSA response (>=0% to <30% vs >=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (>=0% to <30% vs >=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with < 1 favoring Enzalutamide.||
1635847|NCT01995513|3005882|Superiority or Other (legacy)||Hazard Ratio (HR)|0.828||||0.2176|2-Sided|95.0|0.612|1.119||P-value was based on log-rank test stratified by PSA response (greater than or equal to [>=] 0 percent [%] to less than [<] 30% vs >=30%) at Week 13 in the open-label period.|Log Rank||Hazard ratio was based on a Cox regression model (with treatment as the only covariate) stratified by PSA response (>=0% to <30% vs >=30%) at Week 13 in the open-label period and is relative to Enzalutamide-placebo with < 1 favoring Enzalutamide.||
1635848|NCT01995461|3005884|Superiority or Other|||||||0.1349|||||||t-test, 2 sided|paired t-test|||
1635849|NCT01995461|3005885|Superiority or Other|||||||0.0154|||||||t-test, 2 sided|paired t-test|||
1635850|NCT01995461|3005886|Superiority or Other|||||||0.0252|||||||t-test, 2 sided|paired t-test|||
1635851|NCT01995201|3005940|Other|||||||0.5231|||||||Chi-squared||||
1635852|NCT01994954|3005979|Superiority|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Power calculations were based on the primary analysis (t-test comparing changes). A sample size of 130 would have given 80% power, with 0.05 two sided type 1 error rate, to detect a 20% absolute difference in emotional role limitation on the PedsQL v2.0, which we considered to be statistically significant.|
1635853|NCT01994954|3005980|Superiority||||||<|0.03||||||A two-sided P-value of 0.05 or less was interpreted as a statistically significant result.|t-test, 2 sided|||The trial was designed to have 97% power at a type I error rate of 5% to detect a 25% intervention effect with respect to the primary outcome. this was done using an independent sample t-test. P-value was calculated, and a p-value of 0.05 or less was interpreted as statistically significant result.|
1635854|NCT01994889|3005982|Superiority||||||<|0.0001|||||||Chi-squared||||
1635855|NCT01994889|3005983|Superiority||Hazard Ratio (HR)|0.691||||0.0383|2-Sided|95.0|0.488|0.98|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and NYHA baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.||
1635856|NCT01994889|3005984|Superiority||LS Mean Difference|13.65|Standard Error of the Mean|2.13|<|0.0001|2-Sided|95.0|9.48|17.83|||Mixed Model Repeated Measures ANCOVA|||Change at Month 30|
1635857|NCT01994889|3005985|Superiority||Least Square Mean Difference|75.68|Standard Error of the Mean|9.236|<|0.0001|2-Sided|95.0|57.56|93.8|||Mixed Model Repeated Measures ANCOVA|||L.S. means are from an ANCOVA (MMRM) model with an unstructured covariance matrix; center and participant within center as random effects; treatment, visit, TTR genotype (variant and wild-type), and visit by treatment interaction, as fixed effects and baseline score as covariate.|
1635858|NCT01994889|3005986|Superiority||Risk Ratio (RR)|0.6761|||<|0.0001|2-Sided|95.0|0.5639|0.8107||Poisson regression analysis with treatment, TTR genotype, NYHA baseline classification, treatment-by-TTR genotype interaction, and treatment-by-NYHA baseline classification interaction terms as factors adjusted for treatment duration.|Poisson regression analysis||||
1635859|NCT01994889|3005987|Superiority||Hazard Ratio (HR)|0.698||||0.0259|2-Sided|95.0|0.508|0.958|||Cox proportional hazards model||Hazard ratio from a Cox proportional hazards model with treatment, TTR genotype (variant and wild-type) and New York Heart Association (NYHA) baseline classification (NYHA Classes I and II combined and NYHA Class III) in the model.||
1635860|NCT01994889|3005988|Superiority|||||||0.0006|||||||Finkelstein-Schoenfeld Method||||
1635861|NCT01994720|3006014|Superiority or Other||Hazard Ratio (HR)|2.26|||<|0.0001|2-Sided|95.0|1.53|3.34|||Regression, Cox||||
1635862|NCT01994720|3006015|Superiority or Other||Hazard Ratio (HR)|0.83||||0.4511|2-Sided|95.0|0.52|1.34|||Regression, Cox|||PLATO Major bleeding|
1635863|NCT01994720|3006021|Superiority or Other||Hazard Ratio (HR)|0.9||||0.2126|2-Sided|95.0|0.77|1.06|||Regression, Cox||||
1635864|NCT01994720|3006022|Superiority or Other||Hazard Ratio (HR)|1.06||||0.8557|2-Sided|95.0|0.55|2.06|||Regression, Cox||||
1635865|NCT01994720|3006023|Superiority or Other||Hazard Ratio (HR)|0.86||||0.0342|2-Sided|95.0|0.75|0.99|||Regression, Cox||||
1635866|NCT01994720|3006024|Superiority or Other||Odds Ratio (OR)|0.93||||0.1393|2-Sided|95.0|0.85|1.02|||Regression, Logistic||||
1635867|NCT01994720|3006025|Superiority or Other||Hazard Ratio (HR)|1.2||||0.5457|2-Sided|95.0|0.67|2.14|||Regression, Cox||||
1635868|NCT01994720|3006026|Superiority or Other||Hazard Ratio (HR)|1.18||||0.4828|2-Sided|95.0|0.75|1.85|||Regression, Cox||||
1635869|NCT01994720|3006027|Superiority or Other||Hazard Ratio (HR)|1.18||||0.3641|2-Sided|95.0|0.83|1.67|||Regression, Cox||||
1635870|NCT01994720|3006028|Superiority or Other||Hazard Ratio (HR)|0.89||||0.0771|2-Sided|95.0|0.78|1.01|||Regression, Cox||||
1635871|NCT01994720|3006029|Superiority or Other||Hazard Ratio (HR)|0.9||||0.0928|2-Sided|95.0|0.79|1.02|||Regression, Cox||||
1635872|NCT01994720|3006030|Superiority or Other||Hazard Ratio (HR)|0.87||||0.0462|2-Sided|95.0|0.76|1.0||If the treatment effect on the primary efficacy variable is significant at the 4.98% level, the secondary efficacy variable will be tested in a confirmatory sense. Otherwise it will be tested in an exploratory manner.|Regression, Cox|||Ischemic stroke|
1635873|NCT01994720|3006031|Superiority or Other||Hazard Ratio (HR)|0.89||||0.067|2-Sided|95.0|0.78|1.01||In order to address the issue of multiple testing, a hierarchical test sequence will be used. Tested at 4.98% level.|Regression, Cox|||Composite of stroke/MI/death|
1635874|NCT01994291|3006066|Superiority or Other||Difference in LS means|0.46|Standard Error of the Mean|0.13||0.0004|2-Sided|80.0|0.3|0.63|||ANCOVA||||
1635875|NCT01994291|3006066|Superiority or Other||Difference in LS means|0.55|Standard Error of the Mean|0.15||0.0004|2-Sided|80.0|0.36|0.75|||ANCOVA||||
1635876|NCT01994291|3006066|Superiority or Other||Difference in LS means|0.34|Standard Error of the Mean|0.17||0.0423|2-Sided|80.0|0.13|0.55|||ANCOVA||||
1635877|NCT01994291|3006067|Superiority or Other||Difference in LS means|7.07|Standard Error of the Mean|1.09|<|0.0001|2-Sided|80.0|5.66|8.48|||ANCOVA||||
1635878|NCT01994291|3006067|Superiority or Other||Difference in LS means|6.34|Standard Error of the Mean|1.28|<|0.0001|2-Sided|80.0|4.7|7.98|||ANCOVA||||
1635879|NCT01994291|3006067|Superiority or Other||Difference in LS means|7.98|Standard Error of the Mean|1.44|<|0.0001|2-Sided|80.0|6.13|9.83|||ANCOVA||||
1635880|NCT01994291|3006068|Superiority or Other||Difference in LS means|87.32|Standard Error of the Mean|15.44|<|0.0001|2-Sided|80.0|67.45|107.19|||Mixed Models Analysis||||
1635881|NCT01994291|3006068|Superiority or Other||Difference in LS means|65.81|Standard Error of the Mean|18.36|<|0.0004|2-Sided|80.0|42.2|89.43|||Mixed Models Analysis||||
1635882|NCT01994291|3006068|Superiority or Other||Difference in LS means|114.07|Standard Error of the Mean|19.84|<|0.0001|2-Sided|80.0|88.56|139.59|||Mixed Models Analysis||||
1635883|NCT01994291|3006069|Superiority or Other||Risk Difference (RD)|-0.0849||||0.0778|2-Sided|80.0|-0.1516|-0.0168|||Barnard test.||||
1635884|NCT01994291|3006069|Superiority or Other||Risk Difference (RD)|-0.0442||||0.4209|2-Sided|80.0|-0.1217|0.0261|||Barnard test.|||baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.|
1635885|NCT01994291|3006069|Superiority or Other||Risk Difference (RD)|-0.1416||||0.0218|2-Sided|80.0|-0.2483|-0.0467|||Barnard test||||
1635886|NCT01994291|3006070|Non-Inferiority or Equivalence|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.41|Standard Error of the Mean|1.17||0.0399|2-Sided|80.0|-3.91|-0.91|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.|
1635887|NCT01994291|3006070|Non-Inferiority or Equivalence|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.48|Standard Error of the Mean|1.36||0.0699|2-Sided|80.0|-4.24|-0.73|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.|
1635888|NCT01994291|3006070|Non-Inferiority or Equivalence|Non inferiority was to be declared if the lower limit of the confidence interval for the mean difference at Week 12 is greater than -3.0 letters.|Difference in LS means|-2.32|Standard Error of the Mean|1.52||0.1271|2-Sided|80.0|-4.27|-0.37|||Mixed Models Analysis|||The null hypothesis was that the difference, in the mean change from baseline in BCVA in the PF-04634817 group,and the control group is less than or equal to -3 letters.|
1635889|NCT01994109|3006072|Superiority||||||<|0.0001|||||||ANCOVA||||
1635890|NCT01994109|3006072|Superiority||||||<|0.0001|||||||ANCOVA||||
1635891|NCT01994109|3006073|Superiority||||||<|0.0001|||||||ANCOVA||||
1635892|NCT01994109|3006073|Superiority||||||<|0.0001|||||||ANCOVA||||
1635893|NCT01993940|3006074|Superiority or Other||LS Mean Difference|0.75|Standard Error of the Mean|0.227||0.0011|2-Sided|95.0|0.3|1.19|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.|||
1635894|NCT01993940|3006075|Superiority or Other||LS Mean Difference|1.15|Standard Error of the Mean|0.232|<|0.0001|2-Sided|95.0|0.7|1.61|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.|||
1635895|NCT01993940|3006076|Superiority or Other||LS Mean Difference|2.17|Standard Error of the Mean|0.277|<|0.0001|2-Sided|95.0|1.63|2.71|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.|||
1635896|NCT01993940|3006077|Superiority or Other||LS Mean Difference|1.4|Standard Error of the Mean|0.243|<|0.0001|2-Sided|95.0|0.92|1.88|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.|||
1635897|NCT01993940|3006078|Superiority or Other||Difference|18.9|Standard Error of the Mean|4.12|<|0.0001|2-Sided|95.0|10.8|27.0||To control the overall type I error rate to be ≤ 0.05 for the primary and secondary efficacy endpoints, a fixed-sequence (hierarchical) testing approach was applied.|Cochran-Mantel-Haenszel|P-value was calculated by Cochran-Mantel-Haenszel test adjusted by the opioid dose strata.|||
1635898|NCT01993888|3006087|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1635899|NCT01993875|3006088|Superiority|||||||0.0664||||||Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline mean score as random effect.|ANCOVA||||
1636009|NCT01991821|3006296|Superiority|||||||0.06||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected||||
1635900|NCT01993875|3006089|Superiority|||||||0.0664||||||Treatment p-value is from an ANCOVA using the mean straining score as the dependent variable, treatment as fixed effect, and the baseline straining score as random effect.|ANCOVA||||
1635901|NCT01993875|3006090|Superiority|||||||0.2177||||||Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.|ANCOVA||||
1635902|NCT01993875|3006091|Superiority|||||||0.2177||||||Treatment p-value is from an ANCOVA using the mean stool consistency score as the dependent variable, treatment as fixed effect, and the baseline consistency score as random effect.|ANCOVA||||
1635903|NCT01993875|3006092|Superiority|||||||0.129||||||Treatment p-value is from an ANCOVA using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.|ANCOVA||||
1635904|NCT01993875|3006093|Superiority|||||||0.129||||||Treatment p-value is from an analysis of co-variance (ANCOVA) using the SBM rate as the dependent variable, treatment as fixed effect, and baseline rate as random effect.|ANCOVA||||
1635905|NCT01993849|3006094|Superiority||Mean Difference (Final Values)|0.61||||0.69|2-Sided|95.0|-3.81|2.59||The p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided||||
1635906|NCT01993836|3006096|Other|||||||0.801|||||||Wilcoxon Signed Rank||||
1635907|NCT01993836|3006097|Other|||||||0.082|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week P-Tau/Abeta Change between anesthetic groups|
1635908|NCT01993836|3006097|Other|||||||0.439|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Tau/Abeta ratio Change between anesthetic groups|
1635909|NCT01993836|3006098|Other|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week P-Tau Change between anesthetic groups|
1635910|NCT01993836|3006098|Other|||||||0.565|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Abeta Change between anesthetic groups|
1635911|NCT01993836|3006098|Other|||||||0.532|||||||Wilcoxon (Mann-Whitney)|||Difference in 6-week Tau Change between anesthetic groups|
1635912|NCT01993836|3006099|Other|||||||0.36|||||||t-test, 2 sided||||
1635913|NCT01993836|3006100|Other||Spearman Correlation|0.16|||||2-Sided|95.0|-0.05|0.34||||||Correlation between 6-week change in P-Tau/Abeta ratio and continuous cognitive index|
1635914|NCT01993836|3006100|Other||Spearman Correlation|0.02|||||2-Sided|95.0|-0.19|0.22||||||Correlation between 6-week change in Tau/Abeta ratio and continuous cognitive index|
1635915|NCT01993836|3006101|Other||Spearman Correlation|0.12|||||2-Sided|95.0|-0.08|0.32||||||Correlation between 6-week change in P-Tau and continuous cognitive index|
1635916|NCT01993836|3006101|Other||Spearman Correlation|-0.08|||||2-Sided|95.0|-0.29|0.13||||||Correlation between 6-week change in Abeta and continuous cognitive index|
1635917|NCT01993836|3006101|Other||Spearman Correlation|-0.03|||||2-Sided|95.0|-0.23|0.18||||||Correlation between 6-week change in Tau and continuous cognitive index|
1635918|NCT01993186|3006113|Superiority||Least squares mean difference|1.568|Standard Error of the Mean|3.8899||0.3435|2-Sided|90.0|-4.83|7.97||One-sided p-value. Additional model covariates include baseline GMFM-88 total score, visit and the interaction between visit and treatment.|GEE model|||GMFM-88 UX007-Placebo|
1635919|NCT01993186|3006115|Superiority||Least squares mean difference|-1.354|Standard Error of the Mean|3.5759||0.6476|2-Sided|90.0|-7.236|4.527||One-sided p-value. Additional model covariates include the corresponding baseline value, visit and the interaction between visit and treatment.|GEE model|||6MWT distance traveled (percent predicted)|
1635920|NCT01993186|3006116|Superiority||Least squares mean difference|-6.897|Standard Error of the Mean|22.4806||0.6205|2-Sided|90.0|-43.874|30.08||One-sided p-value. Additional model covariates include the corresponding baseline value, visit and the interaction between visit and treatment.|GEE model|||6MWT distance traveled|
1635921|NCT01993186|3006117|Superiority||Least squares mean difference|0.038|Standard Error of the Mean|0.6495||0.5235|2-Sided|90.0|-1.03|1.11||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SWMS68|
1635922|NCT01993186|3006117|Superiority||LS Mean Difference|-1.237|Standard Error of the Mean|2.381||0.3017|2-Sided|90.0|-5.15|2.68||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SWMBE48|
1635923|NCT01993186|3006118|Superiority||Least squares mean difference|0.06|Standard Error of the Mean|0.4988||0.4522|2-Sided|90.0|-0.76|0.88||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||SSPSLF|
1635924|NCT01993186|3006119|Superiority||Least squares mean difference|-0.531|Standard Error of the Mean|2.1853||0.5959|2-Sided|90.0|-4.13|3.06||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||PALFTMS|
1635925|NCT01993186|3006119|Superiority||Least squares mean difference|17.768|Standard Error of the Mean|11.5659||0.9378|2-Sided|90.0|-1.26|36.79||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||PALTEA|
1635926|NCT01993186|3006120|Superiority||Least squares mean difference|-63.835|Standard Error of the Mean|60.6496||0.1463|2-Sided|90.0|-163.59|35.93||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTIMDFRT|
1635927|NCT01993186|3006120|Superiority||Least squares mean difference|63.669|Standard Error of the Mean|53.0537||0.8849|2-Sided|90.0|-23.6|150.94||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTIMDSRT|
1635928|NCT01993186|3006120|Superiority||Least squares mean difference|-2.384|Standard Error of the Mean|68.1231||0.486|2-Sided|90.0|-114.44|109.67||One-sided p-value. Additional model covariates include the corresponding baseline CANTAB score, visit and the interaction between visit and treatment.|GEE model|||RTISRTSD|
1635929|NCT01993186|3006124|Superiority||Hodges-Lehmann estimate|0.0||||0.7276|2-Sided|90.0|0.0|37.5|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% CI and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test|
1636010|NCT01991821|3006297|Superiority|||||||0.26||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected||||
1635930|NCT01993186|3006125|Superiority||Hodges-Lehmann estimate|0.0||||0.8197|2-Sided|90.0|-51.23|84.25|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% CI and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test|
1635931|NCT01993186|3006128|Superiority||Hodges-Lehmann estimate|13.45||||0.5812|2-Sided|90.0|-38.63|80.95|||Wilcoxon rank-sum test|||Non-parametric post-hoc analysis: Hodges-Lehmann estimate of the location shift with 90% confidence interval (CI) and Wilcoxon Rank Sum test p-value, based on Wilcoxon rank-sum test|
1635932|NCT01993108|3006129|Superiority||Median Difference (Final Values)|0.11||||0.552|2-Sided||||||t-test, 2 sided||||
1635933|NCT01993108|3006129|Superiority||Mean Difference (Final Values)|0.04||||0.852|2-Sided||||||t-test, 2 sided||||
1635934|NCT01993108|3006129|Superiority||Mean Difference (Final Values)|0.31||||0.126|2-Sided||||||t-test, 2 sided||||
1635935|NCT01993108|3006129|Superiority||Mean Difference (Final Values)|0.01||||0.926|2-Sided||||||t-test, 2 sided||||
1635936|NCT01993108|3006130|Superiority||Mean Difference (Net)|0.01||||0.593|2-Sided||||||t-test, 2 sided||||
1635937|NCT01993108|3006130|Superiority||Mean Difference (Final Values)|0.0||||0.814|2-Sided||||||t-test, 2 sided||||
1635938|NCT01993108|3006130|Superiority||Mean Difference (Final Values)|0.02||||0.497|2-Sided||||||t-test, 2 sided||||
1635939|NCT01993108|3006130|Superiority||Mean Difference (Final Values)|0.05||||0.049|2-Sided||||||t-test, 2 sided||||
1635940|NCT01993108|3006131|Superiority||Median Difference (Final Values)|0.04||||0.247|2-Sided||||||t-test, 2 sided||||
1635941|NCT01993108|3006131|Superiority||Median Difference (Final Values)|0.06||||0.081|2-Sided||||||t-test, 2 sided||||
1635942|NCT01993108|3006131|Superiority||Mean Difference (Final Values)|0.02||||0.24|2-Sided||||||t-test, 2 sided||||
1635943|NCT01993108|3006131|Superiority||Mean Difference (Final Values)|0.07||||0.019|2-Sided||||||t-test, 2 sided||||
1635944|NCT01993108|3006132|Superiority||Median Difference (Final Values)|0.02||||0.348|2-Sided||||||t-test, 2 sided||||
1635945|NCT01993108|3006132|Superiority||Median Difference (Final Values)|0.02||||0.349|2-Sided||||||t-test, 2 sided||||
1635946|NCT01993108|3006132|Superiority||Mean Difference (Final Values)|0.02||||0.118|2-Sided||||||t-test, 2 sided||||
1635947|NCT01993108|3006132|Superiority||Mean Difference (Final Values)|0.03||||0.02|2-Sided||||||t-test, 2 sided||||
1635948|NCT01993030|3006133|Superiority or Other|||||||0.02||||||Values of p < 0.05 were considered to be significantly different.|t-test, 2 sided|||Two-sided t-test was performed to assess statistically significant differences of the data of the Time to Wound Healing between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.|
1635949|NCT01993030|3006134|Superiority or Other|||||||0.11||||||Values of p < 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Exudation between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to No exudation and Little exudation category."|
1635950|NCT01993030|3006135|Superiority or Other|||||||0.11||||||Values of p < 0.05 were considered to be significantly different.|t-test, 2 sided|||Two-sided t-test was performed to assess statistically significant differences of the data of the VAS score between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.|
1635951|NCT01993030|3006136|Superiority or Other|||||||0.36||||||Values of p < 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Inflammatory Reaction between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to the Participants with Inflammatory Reaction and the Participants without Inflammatory Reaction category."|
1635952|NCT01993030|3006137|Superiority or Other|||||||0.49||||||Values of p < 0.05 were considered to be significantly different.|Fisher Exact|||"Two-sided Fisher's exact test was performed to assess statistically significant differences of the data of the Number of Participants with Growth of Granulation Tissue between the group treated with the HQ® Matrix Medical Wound Dressing and that treated with the Sidaiyi® wound dressing.~This Statistical Analysis applies to the Participants with healthy granulation tissue and the Participants with unhealthy granulation tissue category."|
1635953|NCT01993017|3006140|Superiority|||||||0.98||||||A 2-step gatekeeping test procedure was used. An omnibus F test using ANOVA comparing the 3 groups was first performed. Pairwise comparisons using a 2-sided t test at 5% nominal significance were planned only if the omnibus F test had a P value <.05.|ANOVA|||We determined that a sample size per group of 500, assuming 5% loss to follow-up, would yield 80% power for a 2-sided t test at the 5% level. These calculations were based on an assumed SD for QALYs of 0.17, expected prevalence of screening-detected depression of 20%, and assumed net improvement in QALYs of 0.155 over 18 months for individuals with depression who received treatment for depression in the Screen, Notify, and Treat group.|
1635954|NCT01992523|3006217|Superiority or Other|||||||0.006|||||||t-test, 2 sided|||Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%). Data were compared by means of the chi-2 test or Fisher exact test for categorical variables and unpaired t test or Mann-Whitney U-test for continuous variables, as appropriate. A P value < .05 was considered statistically significant. All tests were two-sided.|
1635955|NCT01992159|3006222|Superiority||Treatment Difference|153.8|||<|0.0001|2-Sided|95.0|109.2|198.4|||ANCOVA|ANCOVA model with the AUC of P1NP at months 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.|||
1635956|NCT01992159|3006222|Superiority||Treatment Difference|84.1|||<|0.0002|2-Sided|95.0|40.1|128.0|||ANCOVA|ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.|||
1635957|NCT01992159|3006222|Superiority||Treatment Difference|-15.3|||<|0.5084|2-Sided|95.0|-60.8|30.2|||ANCOVA|ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.|||
1636011|NCT01991821|3006298|Superiority|||||||0.053||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected||||
1635958|NCT01992159|3006227|Superiority||Treatment Difference|3.5|||<|0.0001|1-Sided|95.0|2.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635959|NCT01992159|3006227|Superiority||Treatment Difference|2.6|||<|0.0001|1-Sided|95.0|1.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635960|NCT01992159|3006227|Superiority||Treatment Difference|1.6|||<|0.0067|1-Sided|95.0|0.5||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635961|NCT01992159|3006228|Superiority||Treatment Difference|2.6||||0.0001|1-Sided|95.0|1.5||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635962|NCT01992159|3006228|Superiority||Treatment Difference|1.3||||0.0151|1-Sided|95.0|0.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635963|NCT01992159|3006228|Superiority||Treatment Difference|0.3||||0.2846|1-Sided|95.0|-0.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635964|NCT01992159|3006229|Superiority||Treatment Difference|4.1|||<|0.0001|1-Sided|95.0|3.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635965|NCT01992159|3006229|Superiority||Treatment Difference|2.6|||<|0.0001|1-Sided|95.0|1.8||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635966|NCT01992159|3006229|Superiority||Treatment Difference|1.5|||<|0.0012|1-Sided|95.0|0.7||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635967|NCT01992159|3006230|Superiority||Treatment Difference|2.6|||<|0.0001|1-Sided|95.0|1.7||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635968|NCT01992159|3006230|Superiority||Treatment Difference|1.7|||<|0.0002|1-Sided|95.0|0.9||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635969|NCT01992159|3006230|Superiority||Treatment Difference|0.6|||<|0.125|1-Sided|95.0|-0.3||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635970|NCT01992159|3006231|Superiority||Treatment Difference|11.9|||<|0.0001|1-Sided|95.0|10.6||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635971|NCT01992159|3006231|Superiority||Treatment Difference|9.0|||<|0.0001|1-Sided|95.0|8.0||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1636581|NCT01976988|3007738|Superiority or Other|||||||0.46|||||||Wilcoxon (Mann-Whitney)||||
1635972|NCT01992159|3006231|Superiority||Treatment Difference|5.3|||<|0.0001|1-Sided|95.0|4.4||||Repeated Measures Model|||The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635973|NCT01992159|3006232|Superiority||Treatment Difference|16.0|||<|0.0001|1-Sided|95.0|14.6|||One-sided p-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg’s method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635974|NCT01992159|3006232|Superiority||Treatment Difference|12.4|||<|0.0001|1-Sided|95.0|11.1|||P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg’s method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635975|NCT01992159|3006232|Superiority||Treatment Difference|7.5|||<|0.0001|1-Sided|95.0|6.5|||P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg’s method to control type 1 error for the primary endpoint.|Repeated Measures Model|||The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.|
1635976|NCT01992107|3006235|Superiority or Other||Difference b/w SC rates(Day 22/Day 50)|-34.0|||||2-Sided|95.0|-38.8|-29.3||||||Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c – %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.|
1635977|NCT01992107|3006236|Superiority or Other||Ratios of GMT (Day 22/Day 50)|0.38|||||2-Sided|95.0|0.35|0.42||||||Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1.The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.|
1635978|NCT01992107|3006237|Superiority or Other||Difference b/w SC rates(Day 22/Day 50)|-47.0|||||2-Sided|95.0|-51.1|-42.1||||||Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2.The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c – %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points met.|
1635979|NCT01992107|3006238|Superiority or Other||Ratios of GMT (Day 22/Day 50)|0.25|||||2-Sided|95.0|0.22|0.29||||||Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2.The upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c/GMTQIVc) for HI antibody should not exceed the superiority margin of 1 met.|
1635980|NCT01992107|3006244|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c – % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|-2.0|||||2-Sided|95.0|-6.5|3.2||||||Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B2|
1635981|NCT01992107|3006244|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c – % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|0.0|||||2-Sided|95.0|-5.5|4.5||||||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B1|
1635982|NCT01992107|3006244|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c – % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|4.0|||||2-Sided|95.0|-1.4|9.2||||||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H3N2|
1635983|NCT01992107|3006244|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c – % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference b/w SC rates (Day 22/Day 50)|2.0|||||2-Sided|95.0|-2.5|6.9||||||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain A/H1N1|
1635984|NCT01992107|3006245|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.0|||||2-Sided|95.0|0.87|1.14||||||Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2|
1635985|NCT01992107|3006245|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|0.99|||||2-Sided|95.0|0.89|1.1||||||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1|
1636012|NCT01991821|3006299|Superiority|||||||0.059||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected||||
1636042|NCT01990612|3006446|Superiority||Risk Ratio (RR)|0.9||||0.13|2-Sided|95.0|0.79|1.03|||Chi-squared||||
1636582|NCT01976988|3007739|Superiority or Other|||||||1|||||||Fisher Exact||||
1635986|NCT01992107|3006245|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.05|||||2-Sided|95.0|0.97|1.14||||||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H3N2|
1635987|NCT01992107|3006245|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT (Day 22/Day 50)|1.03|||||2-Sided|95.0|0.93|1.14||||||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H1N1|
1635988|NCT01992094|3006248|Non-Inferiority or Equivalence|The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c – %seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.|Difference between seroconversion rates|-21.7|||||2-Sided|95.0|-25.5|-17.7||||||Superiority of immune responses of QIVc to TIV2c in terms of seroconversion rates against influenza strain B1|
1635989|NCT01992094|3006249|Non-Inferiority or Equivalence|The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.|Ratios of GMT|0.5|||||2-Sided|95.0|0.5|0.5||||||Superiority of immune responses of QIVc to TIV2c in terms of ratios of GMT against influenza strain B1|
1635990|NCT01992094|3006250|Non-Inferiority or Equivalence|The upper bound of the 2-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c or TIV2c – % seroconversion QIVc) for HI antibody should not exceed the margin of 0 points.|Difference between seroconversion rates|-19.4|||||2-Sided|95.0|-23.2|-15.5||||||Superiority of immune responses of QIVc to TIV1c in terms of seroconversion rates against influenza strain B2|
1635991|NCT01992094|3006251|Non-Inferiority or Equivalence|The upper bound of the 2-sided 95% CI for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody should not exceed the superiority margin of 1.|Ratios of GMT|0.6|||||2-Sided|95.0|0.6|0.7||||||Superiority of immune responses of QIVc to TIV1c in terms of ratios of GMT against influenza strain B2|
1635992|NCT01992094|3006257|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c – % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-4.4|||||2-Sided|95.0|-8.9|0.2||||||Non-inferiority of immune responses of QIVc to TIV2c in terms of differences in seroconversion rates against influenza strain B2|
1635993|NCT01992094|3006257|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c – % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-1.8|||||2-Sided|95.0|-6.2|2.8||||||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain B1|
1635994|NCT01992094|3006257|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c – % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-2.7|||||2-Sided|95.0|-7.2|1.9||||||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strainH3N2|
1635995|NCT01992094|3006257|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c – % seroconversion QIVc) for HI antibody does not exceed the margin of 10%|Difference between seroconversion rates|-0.5|||||2-Sided|95.0|-5.3|4.2||||||Non-inferiority of immune responses of QIVc to TIV1c in terms of differences in seroconversion rates against influenza strain H1N1|
1635996|NCT01992094|3006258|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|0.9|||||2-Sided|95.0|0.9|1.0||||||Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2|
1635997|NCT01992094|3006258|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|0.9|||||2-Sided|95.0|0.8|1.0||||||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1|
1635998|NCT01992094|3006258|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|1.0|||||2-Sided|95.0|0.9|1.1||||||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H3N2|
1635999|NCT01992094|3006258|Non-Inferiority or Equivalence|Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5|Ratios of GMT|1.0|||||2-Sided|95.0|0.9|1.1||||||Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H1N1|
1636000|NCT01991860|3006287|Superiority|||||||0.15|||||||Chi-squared, Corrected|Yates’s continuity correction|||
1636001|NCT01991860|3006288|Superiority|||||||0.074|||||||Chi-squared, Corrected|Yates’s continuity correction|||
1636002|NCT01991860|3006289|Superiority|||||||0.086|||||||Chi-squared, Corrected|Yates’s continuity correction|||
1636003|NCT01991860|3006290|Superiority|||||||0.026|||||||Chi-squared, Corrected|Yates’s continuity correction|||
1636004|NCT01991860|3006291|Superiority|||||||0.68|||||||Chi-squared, Corrected|Yates’s continuity correction|||
1636005|NCT01991860|3006292|Superiority|||||||0.16|||||||Chi-squared, Corrected|Yates’s continuity correction|||
1636006|NCT01991860|3006293|Superiority|||||||0.033||||||2-sided|Chi-squared, Corrected|Yates’s continuity correction|||
1636007|NCT01991821|3006294|Superiority|||||||0.096|||||||Chi-squared, Corrected||||
1636008|NCT01991821|3006295|Superiority|||||||0.079||||||Two-sided, significance threshold = 0.05|Chi-squared, Corrected||||
1636013|NCT01991821|3006300|Superiority|||||||0.093||||||The complete response of the primary efficacy analysis occurred in 95 patients (56.2%; 95% confidence interval [CI] 48.4 – 63.8%) in the APD421 group and 83 patients (46.6%; 95% CI 39.1– 54.2%) in the placebo group|Chi-squared, Corrected|Pearson square test with Yates's continuity correction and with the two- sided significance level of 5%||The primary efficacy analysis was a complete response which is defined as protection from PONV1, which was absence of any episode of emesis, significant nausea or use of rescue medication with the first 24 hours post-operatively.|
1636014|NCT01991795|3006302|Superiority||Hazard Ratio (HR)|4.04|||<|0.0001|2-Sided|95.0|3.32|4.92|||Regression, Cox||||
1636015|NCT01991795|3006303|Superiority||Hazard Ratio (HR)|2.41|||<|0.0001|2-Sided|95.0|1.98|2.93|||Regression, Cox||||
1636016|NCT01991795|3006304|Superiority||Hazard Ratio (HR)|2.49|||<|0.0001|2-Sided|95.0|2.02|3.07|||Regression, Cox||||
1636017|NCT01991795|3006305|Superiority||Hazard Ratio (HR)|2.32|||<|0.0001|2-Sided|95.0|1.82|2.94|||Regression, Cox||||
1636018|NCT01991795|3006306|Superiority||Hazard Ratio (HR)|0.98||||0.6846|2-Sided|95.0|0.87|1.1|||Regression, Cox||||
1636019|NCT01991795|3006307|Superiority||Hazard Ratio (HR)|0.8||||0.0375|2-Sided|95.0|0.64|0.99||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox||||
1636020|NCT01991795|3006308|Superiority||Hazard Ratio (HR)|0.84||||0.0294|2-Sided|95.0|0.71|0.98||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox||||
1636021|NCT01991795|3006309|Superiority||Hazard Ratio (HR)|1.02||||0.7883|2-Sided|95.0|0.88|1.18||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox||||
1636022|NCT01991795|3006310|Superiority||Hazard Ratio (HR)|0.9||||0.0378|2-Sided|95.0|0.81|0.99||The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox||||
1636023|NCT01991314|3006343|Superiority or Other||Mean Difference (Net)|-15.9|||<|0.0001|2-Sided||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test|
1636024|NCT01991314|3006344|Superiority or Other||Mean Difference (Net)|-1.0||||0.69|2-Sided||||||Wilcoxon (Mann-Whitney)|||Mann Whitney U test|
1636025|NCT01991314|3006345|Superiority or Other||Mean Difference (Net)|-0.4||||0.85|2-Sided||||||Wilcoxon (Mann-Whitney)|||Mann Whitney U test|
1636026|NCT01991314|3006346|Superiority or Other||Mean Difference (Net)|2.5||||0.49|2-Sided||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test|
1636027|NCT01991314|3006347|Superiority or Other||Mean Difference (Net)|-5.0||||0.96|2-Sided||||||t-test, 2 sided|||Unpaired Students t test|
1636028|NCT01991314|3006348|Superiority or Other||difference in proportions|3.6|||<|0.05|2-Sided||||||Fisher Exact|Fisher's exact test was used to compare proportions (expressed as percentages) of total number of participants in each group who were iron intolerant||Chi squared test or Fisher’s exact test, as appropriate.|
1636029|NCT01991314|3006349|Non-Inferiority or Equivalence|We calculated, on the premise that there is non-inferiority between adolescent and adult groups in the difference in increase of mean haemoglobin levels of 0.35g/dL, with estimated standard deviation 0.7g/dL following treatment, that 45 patients in each group would be required, derived using power 80% power, 1-sided significance level 0.05 and R 0.5 for the covariate; this calculation took into account planned ANCOVA methodology and 20% patients who might be lost to follow up or withdraw.|Mean Difference (Net)|0.08||||0.23|2-Sided|||||To test the hypothesis of non-inferiority with maximal statistical power, ANCOVA (one-tailed P<0.05) was employed to compare the change in mean haemoglobin levels between adults and adolescents after accounting for necessary covariates|ANCOVA||||
1636030|NCT01991197|3006359|Superiority||U|29.5||||0.128|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1636031|NCT01991197|3006362|Superiority|||||||1|||||||Fisher Exact||||
1636032|NCT01991197|3006365|Superiority||U value|43.5||||0.648|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1636033|NCT01990768|3006431|Superiority||Odds Ratio (OR)|0.87||||0.1809|1-Sided|||||Based on an interim futility analysis, a one-sided P-value less than .1028 was required to declare benefit.|Regression, Logistic|Analysis was adjusted for regional site. Missing outcomes were multiply imputed.|Odds ratio for unfavorable GOS-E (<=4) for the Combined TXA Arms (numerator) vs. Placebo (denominator)|This study was designed with an asymmetric boundary for tests for treatment harm and benefit. The conventional 0.025 level was used to test for harm while a 0.1 level was used to determine benefit for this Phase II trial. Statistical significance for the primary analysis was conducted under a group-sequential design that included a single, interim futility analysis using a Wang-Tsiatis boundary with parameter 0.8 based on outcome data from the first 200 subjects.|
1636034|NCT01990742|3006432|Other||||||>|0.05|||||||Monte carlo simulation||||
1636035|NCT01990742|3006433|Other||||||>|0.05|||||||Monte carlo simulation||||
1636036|NCT01990742|3006434|Other||||||>|0.05|||||||MOnte carlo simulation||||
1636037|NCT01990612|3006441|Other||Odds Ratio, log|0.98||||0.78|2-Sided|95.0|0.86|1.12|||Regression, Logistic|||Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are only formula feeding to participants who are only breastfeeding.|
1636038|NCT01990612|3006441|Other||Odds Ratio, log|1.01||||0.88|2-Sided|95.0|0.89|1.15||Odds ratios from multinomial logistic regression.|Regression, Logistic|||Multinomial logistic regression using participants who are breastfeeding only as the reference group. This analysis compares the participants who are breastfeeding and formula feeding to participants who are only breastfeeding.|
1636039|NCT01990612|3006443|Superiority|||||||0.002||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Cochran-Armitage trend test||||
1636040|NCT01990612|3006444|Superiority|||||||0.01||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Cochran-Armitage trend test||||
1636043|NCT01990612|3006447|Superiority||Risk Ratio (RR)|1.05||||0.84|2-Sided|95.0|0.66|1.66|||Chi-squared||||
1636044|NCT01990612|3006448|Superiority||Risk Ratio (RR)|1.01||||0.91|2-Sided|95.0|0.81|1.27|||Chi-squared||||
1636045|NCT01990612|3006449|Superiority||Risk Ratio (RR)|0.79||||0.75|2-Sided|95.0|0.2|2.74|||Chi-squared||Exact confidence intervals are provided for rare outcomes.||
1636046|NCT01990612|3006450|Superiority||Risk Ratio (RR)|0.9||||0.56|2-Sided|95.0|0.64|1.28|||Chi-squared||||
1636047|NCT01990612|3006451|Superiority||Risk Ratio (RR)|0.92||||0.56|2-Sided|95.0|0.68|1.23|||Chi-squared||||
1636048|NCT01990612|3006452|Superiority|||||||0.01|||||||Cochran-Armitage trend test||||
1636049|NCT01990612|3006454|Superiority||Risk Ratio (RR)|1.99||||1|2-Sided|95.0|0.26|26.8|||Chi-squared|The P-values has not been adjusted for multiplicity of comparisons of secondary outcomes.|Exact confidence intervals are provided for rare outcomes.||
1636050|NCT01990612|3006455|Superiority||Risk Ratio (RR)|0.76||||0.15|2-Sided|95.0|0.53|1.1|||Chi-squared||||
1636051|NCT01990612|3006456|Superiority||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for Overall labor pain score|
1636052|NCT01990612|3006456|Superiority||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for Worst labor pain score|
1636053|NCT01990612|3006457|Superiority|||||||0.01||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for 4-8 weeks after delivery|
1636054|NCT01990612|3006457|Superiority||||||<|0.001||||||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared|||Analysis for 6-96 hours after delivery|
1636055|NCT01990612|3006458|Superiority||Risk Ratio (RR)|1.03||||0.81|2-Sided|95.0|0.82|1.29|||Chi-squared||||
1636056|NCT01990612|3006459|Superiority||Risk Ratio (RR)|0.64|||<|0.001|2-Sided|95.0|0.56|0.74||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared||||
1636057|NCT01990612|3006460|Superiority||Risk Ratio (RR)|0.5||||0.26|2-Sided|95.0|0.13|1.55|||Chi-squared||Exact confidence intervals are provided for rare outcomes.||
1636058|NCT01990612|3006462|Superiority||Risk Ratio (RR)|1.15||||0.33|2-Sided|95.0|0.87|1.52|||Chi-squared||||
1636059|NCT01990612|3006463|Superiority||Risk Ratio (RR)|0.94||||0.35|2-Sided|95.0|0.83|1.07|||Chi-squared||||
1636060|NCT01990612|3006464|Superiority||Risk Ratio (RR)|0.85||||0.07|2-Sided|95.0|0.72|1.01|||Chi-squared||||
1636061|NCT01990612|3006465|Superiority||Risk Ratio (RR)|0.58||||0.02|2-Sided|95.0|0.36|0.92||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared||||
1636062|NCT01990612|3006466|Superiority||Risk Ratio (RR)|0.84|||<|0.001|2-Sided|95.0|0.76|0.93||The P value remained significant after controlling for multiple comparisons with the false discovery rate method.|Chi-squared||||
1636063|NCT01990612|3006467|Superiority||Risk Ratio (RR)|0.4|||||2-Sided|95.0|0.06|1.79|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.||
1636064|NCT01990612|3006468|Superiority||Risk Ratio (RR)|1.28|||||2-Sided|95.0|0.48|3.42|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.||
1636065|NCT01990612|3006469|Superiority||Risk Ratio (RR)|0.77|||||2-Sided|95.0|0.38|1.55|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.||
1636066|NCT01990612|3006470|Superiority||Risk Ratio (RR)|0.65|||||2-Sided|95.0|0.35|1.19|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.||
1636067|NCT01990612|3006471|Superiority||Risk Ratio (RR)|0.74|||||2-Sided|95.0|0.31|1.76|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.||
1636068|NCT01990612|3006472|Superiority||Risk Ratio (RR)|2.74|||||2-Sided|95.0|0.91|8.12|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.||
1636069|NCT01990612|3006473|Superiority||Risk Ratio (RR)|0.7|||||2-Sided|95.0|0.35|1.37|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.||
1636070|NCT01990612|3006474|Superiority||Risk Ratio (RR)|0.66|||||2-Sided|95.0|0.32|1.37|||||Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.||
1636071|NCT01990612|3006475|Superiority||Risk Ratio (RR)|0.71|||||2-Sided|95.0|0.55|0.93|||||||
1636072|NCT01990612|3006476|Superiority||Risk Ratio (RR)|0.66|||||2-Sided|95.0|0.12|3.33|||||Exact confidence intervals are provided for rare outcomes. Widths of the confidence intervals for components of the primary outcome have not been adjusted for multiplicity, and should not be used to infer definitive effects of management strategies.||
1636073|NCT01990612|3006477|Superiority||Risk Ratio (RR)|0.8||||0.049|2-Sided|95.0|0.64|1.0|||Chi-squared|Group sequential method to control type I error w/ Lan–DeMets characterization of O’Brien–Fleming boundary. 2-tailed p-value <0.46 considered stat sig|One interim analysis was performed; in final analysis of the primary outcome, a two-tailed P value of less than 0.046 considered to indicate statistical significance. Since adjustment is minimal, we report 95% confidence interval for relative risk.||
1636074|NCT01990573|3006479|Other|ANOVA|F statistic|0.962||||0.962|2-Sided||||||ANOVA||||
1636075|NCT01990573|3006480|Other|ANOVA|F statistic|0.002||||0.002|2-Sided||||||ANOVA||||
1636076|NCT01990313|3006508|Superiority|||||||0.038|||||||Mixed Models Analysis||||
1636077|NCT01989793|3006527|Equivalence|Equivalence margin = 0||||||0.73|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms|
1636078|NCT01989793|3006528|Equivalence|Equivalence margin = 0||||||0.73|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms|
1636079|NCT01989793|3006529|Equivalence|Equivalence margin = 0||||||0.82|||||||Fisher Exact|||Fisher's exact test of percentage of participants with improvement in frailty score from baseline between treatment and placebo arms|
1636080|NCT01989793|3006530|Equivalence|Equivalence margin=0||||||0.203|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 24|
1636081|NCT01989793|3006531|Equivalence|Equivalence margin=0||||||0.271|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 16|
1636082|NCT01989793|3006532|Equivalence|Equivalence margin=0||||||0.212|||||||t-test, 2 sided|assuming unequal variance between arms||Two-sample T-test of between-arm difference in fatiguability at week 8|
1636083|NCT01989793|3006533|Equivalence|Equivalence margin = 0||||||0.59|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 24|
1636084|NCT01989793|3006534|Equivalence|Equivalence margin=0||||||0.48|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 16|
1636085|NCT01989793|3006535|Equivalence|Equivalence margin=0||||||0.97|||||||t-test, 2 sided|||Two-sample T-test of between-arm difference of change in isokinetic knee strength from baseline to week 8|
1636086|NCT01989754|3006536|Superiority||Hazard Ratio (HR)|0.86|||=|0|2-Sided|95.0|0.61|1.22|||Stratified Cox proportional hazard||||
1636087|NCT01989754|3006537|Superiority||Hazard Ratio (HR)|0.72|||=|0|2-Sided|95.0|0.55|0.94|||Stratified Cox proportional hazard||||
1636088|NCT01989754|3006538|Superiority||Hazard Ratio (HR)|0.64|||<|0.0001|2-Sided|95.0|0.57|0.73|||Cox proportional hazard method||||
1636089|NCT01989676|3006548|Superiority||Cox Proportional Hazard|1.048||||0.581|2-Sided|95.0|0.669|1.642||1-sided log-rank test was used to compare the OS distribution between the two treatment groups and was stratified by prior trastuzumab exposure (Yes/No) and ER status (ER positive vs. ER negative)|Log Rank||||
1636090|NCT01989676|3006549|Superiority||Cox Proportional Hazard|1.08||||0.661|2-Sided|95.0|0.75|1.56||1-sided log-rank test was used to compare the DOR distribution between the two treatment groups and was stratified by Prior Trastuzumab Exposure (Yes/No) and ER Status (ER positive vs. ER negative).|Log Rank||||
1636091|NCT01989676|3006550|Superiority||Cox Proportional Hazard|1.07||||0.691|2-Sided|95.0|0.83|1.37||1-sided log-rank test was used to compare the PFS distribution between the two treatment groups and was stratified by Prior Trastuzumab Exposure (Yes/No) and Estrogen Receptor (ER) Status (ER positive vs. ER negative).|Log Rank||||
1636092|NCT01989676|3006551|Non-Inferiority|The hypothesis to be tested in this study was that the risk ratio of ORR of PF-05280014 versus that of trastuzumab-EU by Week 25 (±14 days) was within a pre-specified margin of 0.80 to 1.25.|Risk Ratio (RR)|0.94|||||2-Sided|95.0|0.842|1.049||||||RR and associated 95% CI are unstratified and based on the Miettinen and Nurminen method.|
1636093|NCT01989572|3006552|Superiority or Other|||||||0.13|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparisons in patients with negative HLA-A2 status|
1636094|NCT01989572|3006552|Superiority or Other|||||||0.91|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with positive HLA-A2 status|
1636095|NCT01989572|3006553|Superiority or Other|||||||0.69|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with negative HLA-A2 status|
1636096|NCT01989572|3006553|Superiority or Other|||||||0.88|||||||Log Rank|stratifying on site of metastases and number of metastatic lesions||Treatment arm comparison in patients with positive HLA-A2 status|
1636097|NCT01989572|3006554|Superiority or Other|||||||0.71||||||stratifying on GM-CSF, site of metastases and number of metastatic lesions|Log Rank||||
1636098|NCT01989572|3006555|Superiority or Other|||||||0.6|||||||Log Rank|stratifying on GM-CSF, site of metastases and number of metastatic lesions|||
1636099|NCT01989572|3006556|Superiority or Other|||||||0.131|||||||Log Rank|stratifying on HLA-A2 status, site of metastases, and number of metastatic lesions|||
1636100|NCT01989572|3006557|Superiority or Other|||||||0.528|||||||Log Rank|stratifying on HLA-A2 status, site of metastases and number of metastatic lesions.|||
1636101|NCT01989455|3006569|Superiority or Other||Percent ratio|73.19|||||2-Sided|90.0|68.83|77.56|||||||
1636102|NCT01989195|3006582|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1636103|NCT01989169|3006583|Non-Inferiority or Equivalence|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.383|||||2-Sided|90.0|1.282|1.491|||||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in Cmax, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.|
1636114|NCT01988779|3006604|Non-Inferiority|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.505|||||||ANOVA||||
1636115|NCT01988662|3006605|Non-Inferiority or Equivalence|"H0: There is no difference in the percent change in VEGF level after 3 months for patients with nAMD treated with ranibizumab compared to aflibercept.~HA: There is a difference in the percent change in VEGF level after 3 months for patients with nAMD treated with ranibizumab compared to aflibercept."|Mean Difference (Net)|62.57|Standard Error of the Mean|24.639||0.012|2-Sided|95.0|13.96|111.17|||Mixed Models Analysis|||H0: μR = μA versus HA: μR ≠ μA|
1636104|NCT01989169|3006584|Non-Inferiority or Equivalence|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.216|||||2-Sided|90.0|1.115|1.327|||||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUClast, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.|
1636105|NCT01989169|3006585|Non-Inferiority or Equivalence|If the 90% CI of the geometric mean ratios were within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|1.215|||||2-Sided|90.0|1.116|1.323|||||The ratio of geometric LS means and 90% CIs for the geometric mean ratio is for Treatment B to Treatment A.|The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in AUCinf, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.|
1636106|NCT01989156|3006586|Superiority or Other (legacy)||Geometric LS Mean Ratio|38.14|||<|0.001|2-Sided|95.0|34.24|42.47||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."|
1636107|NCT01989156|3006587|Superiority or Other (legacy)||Geometric LS Mean Ratio|26.41|||<|0.001|2-Sided|95.0|17.31|40.26||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on Total NNAL levels with product, sex, cigarette consumption, and baseline value as covariates|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."|
1636108|NCT01989156|3006588|Superiority or Other (legacy)||Geometric LS Mean Ratio|12.58|||<|0.001|2-Sided|95.0|9.54|16.58||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."|
1636109|NCT01989156|3006589|Superiority or Other (legacy)||Geometric LS Mean Ratio|45.77|||<|0.001|2-Sided|95.0|39.22|53.41||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."|
1636110|NCT01989156|3006590|Superiority or Other (legacy)||Geometric LS Mean Ratio|12.58|||<|0.001|2-Sided|95.0|9.27|17.05||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS Mean Ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the biomarkers of exposure (BoExp) was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."|
1636111|NCT01988922|3006595|Other|Differences between CYP2B6*1/*1, CYP2B6*1/*6, and CYP2B6*6/*6 genotypes for pharmacokinetic parameters were analyzed using one-way ANOVA followed by the Student–Newman–Keuls test for multiple comparisons (Sigmaplot 12.5; Systat Software, Inc, USA). Nonnormal data were log transformed for analysis but reported as the nontransformed results.|||||<|0.05|||||||ANOVA|One-way ANOVA followed by the Student–Newman–Keuls test for multiple comparisons|||
1636112|NCT01988779|3006601|Non-Inferiority|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.036|||||||ANOVA||||
1636113|NCT01988779|3006602|Non-Inferiority|Assuming that the non-inferiority limit of topical therapy is 20% of that for oral therapy.||||||0.39|||||||ANOVA||||
1636116|NCT01988493|3006612|Equivalence|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.||||||0.0527|||||||Cochran-Mantel-Haenszel||||
1636117|NCT01988493|3006613|Equivalence|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.59||||0.0496|2-Sided|90.0|0.38|0.92|||Log Rank||||
1636118|NCT01988493|3006615|Equivalence|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.||||||0.0438|||||||Cochran-Mantel-Haenszel||||
1636119|NCT01988493|3006616|Equivalence|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|1.04||||0.8915||90.0|0.62|1.77|||Log Rank||||
1636120|NCT01988493|3006629|Equivalence|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.45||||0.0059||90.0|0.28|0.73|||Log Rank||||
1636121|NCT01988493|3006630|Equivalence|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.73||||0.3039||90.0|0.43|1.21|||Log Rank||||
1636122|NCT01988493|3006631|Equivalence|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.53||||0.0229||90.0|0.33|0.84|||Log Rank||||
1636123|NCT01988493|3006632|Equivalence|Sample size required 100 TTP events to ensure 80% power with a two-sided significance level of 10% for rejecting the null hypothesis of equal treatment effect between treatment arms.|Hazard Ratio (HR)|0.42||||0.0043|2-Sided|90.0|0.26|0.74|||Log Rank||||
1636124|NCT01988402|3006640|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1636125|NCT01988129|3006646|Superiority or Other|||||||0.46|||||||Paired t-test, 2-sided||||
1636126|NCT01988129|3006647|Superiority or Other|||||||0.16|||||||Paired t-test, 2-sided|||Sleeping while stopped in traffic|
1636127|NCT01988129|3006648|Superiority or Other|||||||0.31|||||||paired t-test||||
1636128|NCT01988129|3006649|Superiority or Other||Percentage of firefighters screene|9.3|||||2-Sided|||||||||This analysis describes the prevalence of the risk of shiftwork disorder only; there is no comparison group|
1636129|NCT01988129|3006649|Superiority or Other||Percentage of firefighters screene|3.5|||||2-Sided|||||||||This analysis describes the prevalence of the risk of restless legs syndrome only; there is no comparison group|
1636130|NCT01988129|3006649|Superiority or Other||Percentage of firefighters screene|7.7|||||2-Sided|||||||||This analysis describes the prevalence of the risk of insomnia; there is no comparison group|
1636131|NCT01988129|3006649|Superiority or Other||Percentage of firefighters screene|31.3|||||2-Sided|||||||||This analysis describes the prevalence of the risk of obstructive sleep apnea only; there is no comparison group|
1636132|NCT01988129|3006649|Superiority or Other||Percentage of firefighters screened|41.5|||||2-Sided|||||||||This analysis describes the prevalence of the risk of any sleep disorders; there is no comparison group|
1636133|NCT01988129|3006651|Superiority or Other|||||||0.71|||||||paired t-test||||
1636134|NCT01988129|3006652|Superiority or Other|||||||0.65|||||||paired t-test||||
1636135|NCT01988129|3006653|Superiority or Other|||||||0.22|||||||Paired t-test|||Of the 100 participants who completed both the pre- and post-study survey (see Patient Flow), only 62 completed answered the question about sleep duration at both time points|
1636136|NCT01988129|3006654|Superiority or Other||Odds Ratio (OR)|0.76||||0.31|2-Sided|95.0|0.6|0.98|||t-test, 2 sided||The Odds Ratio analyses compared the odds of reporting at least one injury during the study between those who did (n=560) and did not (n=629) attend the education sessions, regardless of station assignment (intervention or control).||
1636137|NCT01988129|3006655|Superiority or Other|||||||0.87|||||||t-test, 2 sided||||
1636138|NCT01988129|3006656|Superiority or Other|||||||0.003|||||||Mixed Models Analysis|Mixed model analysis with nested random effects for possible station-level and station-pairing correlation (3-level hierarchical linear model)||Mixed model analysis was conducted for 'disability/injury' days|
1636139|NCT01988129|3006656|Superiority or Other|||||||0.033|||||||t-test, 2 sided|||Analysis for 'disability/injury' days|
1636140|NCT01988129|3006656|Superiority or Other|||||||0.66|||||||t-test, 2 sided|||Analysis for 'sick' days|
1636141|NCT01988103|3006662|Superiority or Other (legacy)||Mean Difference (Final Values)|1.85||||0.1693|2-Sided|95.0|-0.79|4.5|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.||
1636142|NCT01988103|3006662|Superiority or Other (legacy)||Mean Difference (Final Values)|0.88||||0.5149|2-Sided|95.0|-1.78|3.53|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.||
1636143|NCT01988103|3006663|Superiority or Other (legacy)||Mean Difference (Final Values)|-3.5|||<|0.0001|2-Sided|95.0|-4.9|-2.0|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.||
1636144|NCT01988103|3006663|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.7|||<|0.0204|2-Sided|95.0|-3.2|-0.3|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.||
1636145|NCT01988103|3006664|Superiority or Other (legacy)||Mean Difference (Final Values)|-24.8|||<|0.0001|2-Sided|95.0|-32.7|-16.9|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate. Missing values were imputed using the LOCF method.||
1636202|NCT01986647|3006947|Superiority or Other|||||||0.2691|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data|||
1636146|NCT01988103|3006664|Superiority or Other (legacy)||Mean Difference (Final Values)|-14.6|||<|0.0003|2-Sided|95.0|-22.6|-6.7|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.||
1636147|NCT01988103|3006665|Superiority or Other (legacy)||Difference|29.2|||<|0.0001|2-Sided|95.0|15.4|42.9|||Chi-squared||||
1636148|NCT01988103|3006665|Superiority or Other (legacy)||Difference|19.7|||<|0.0057|2-Sided|95.0|6.1|33.4|||Chi-squared||||
1636149|NCT01988103|3006666|Superiority or Other (legacy)||Mean Difference (Final Values)|-39.5|||<|0.0001|2-Sided|95.0|-54.9|-24.1|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.||
1636150|NCT01988103|3006666|Superiority or Other (legacy)||Mean Difference (Final Values)|-29.5|||<|0.0002|2-Sided|95.0|-44.9|-14.0|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.||
1636151|NCT01988103|3006667|Superiority or Other (legacy)||Mean Difference (Final Values)|-38.0|||<|0.0001|2-Sided|95.0|-53.4|-22.6|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.||
1636152|NCT01988103|3006667|Superiority or Other (legacy)||Mean Difference (Final Values)|-29.1|||<|0.0003|2-Sided|95.0|-44.5|-13.6|||ANCOVA||2-sided 95% CI and p-values were based on an analysis of covariance model with treatment arm as a factor and baseline value as a covariate. Means (LS Means) and p-values were adjusted by covariate.||
1636153|NCT01988103|3006668|Superiority or Other (legacy)||Difference|20.8||||0.002|2-Sided|95.0|8.2|33.3|||Chi-squared||Missing values were imputed using the LOCF method.||
1636154|NCT01988103|3006668|Superiority or Other (legacy)||Difference|15.1||||0.0165|2-Sided|95.0|3.1|27.1|||Chi-squared||||
1636155|NCT01988103|3006669|Superiority or Other (legacy)||Difference|21.1||||0.0003|2-Sided|95.0|10.1|32.1|||Chi-squared||||
1636156|NCT01988103|3006669|Superiority or Other (legacy)||Difference|16.4||||0.0032|2-Sided|95.0|5.8|27.0|||Chi-squared||||
1636157|NCT01988090|3006671|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1636158|NCT01988090|3006673|Superiority|||||||0.7635|||||||Chi-squared||||
1636159|NCT01987895|3006743|Other|Sensitivity analysis|Difference between 2 proportions|1.1|||||2-Sided|95.0|-6.5|8.7|||||CI for the difference between two proportions are estimated using the Wilson's score method||
1636160|NCT01987895|3006744|Other||Difference between 2 proportions|3.7|||||2-Sided|95.0|-3.4|10.7|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis|
1636161|NCT01987895|3006745|Other||Difference between 2 proportions|-1.9|||||2-Sided|95.0|-6.2|2.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis|
1636162|NCT01987895|3006746|Other||Difference between 2 proportions|-1.8|||||2-Sided|95.0|-6.5|2.9|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis|
1636163|NCT01987895|3006747|Superiority||Least Square Mean difference|0.05||||0.488|2-Sided|95.0|-0.09|0.19||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the systemic / other symptoms domain scores|
1636164|NCT01987895|3006747|Superiority||Least Square Mean difference|0.087||||0.2879|2-Sided|95.0|-0.07|0.25||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the abdominal symptoms domain scores|
1636165|NCT01987895|3006747|Superiority||Least Square Mean difference|0.002||||0.9814|2-Sided|95.0|-0.2|0.2||Two-sided 5% alpha level was used|ANOVA|ANOVA for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the diarrhea domain scores|
1636166|NCT01987895|3006748|Superiority||Hazard Ratio (HR)|0.96||||0.6016|2-Sided|95.0|0.8|1.14||two-sided p-value (alpha 5%) based on log-rank test stratified by first occurrence / first recurrence and geographical region.|Log Rank||||
1636167|NCT01987895|3006749|Superiority|Superiority of cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above zero|Difference between 2 proportions|3.3|||||2-Sided|95.0|-4.3|10.8|||||CI for the difference between two proportions are estimated using the Wilson's score method||
1636168|NCT01987895|3006750|Non-Inferiority|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above –10%.|Difference between 2 proportions|-4.1|||||2-Sided|95.0|-9.2|1.0|||||CI for the difference between two proportions are estimated using the Wilson' score method||
1636169|NCT01987895|3006751|Non-Inferiority|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above –10%.|Difference between 2 proportions|-2.4|||||2-Sided|95.0|-8.1|3.2|||||CI for the difference between two proportions are estimated using the Wilson's score method|Sensitivity analysis with imputation for a single day with missing UBM data between one day before end-of-treatment (EOT) and 2 days after EOT|
1636170|NCT01987895|3006751|Non-Inferiority|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above –10%.|Difference between 2 proportions|-1.4|||||2-Sided|95.0|-7.2|4.3|||||CI for the difference between two proportions are estimated using the Wilson's score method||
1636171|NCT01986855|3006897|Superiority or Other||Adjusted Odds Ratio|1.06||||0.89|2-Sided|95.0|0.44|2.55||Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment, baseline treatment with insulin stratum (yes/no), and a covariate for baseline A1C.|Logistic regression model||||
1636408|NCT01981954|3007298|Other|||||||0.61||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636172|NCT01986855|3006897|Superiority or Other||Adjusted Odds Ratio|1.16||||0.713|2-Sided|95.0|0.53|2.56||Adjusted Odds Ratio based on a logistic regression model fitted with fixed effects for treatment, baseline treatment with insulin stratum (yes/no), and a covariate for baseline A1C.|Logistic regression model||||
1636173|NCT01986855|3006898|Superiority or Other||Difference in the least squares means|-15.51||||0.019|2-Sided|95.0|-28.5|-2.53||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis||||
1636174|NCT01986855|3006898|Superiority or Other||Difference in the least squares means|-6.81||||0.291|2-Sided|96.0|-19.47|5.85||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1636175|NCT01986855|3006899|Superiority or Other||Difference in the least squares means|-3.46||||0.072|2-Sided|95.0|-7.24|0.31||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1636176|NCT01986855|3006899|Superiority or Other||Difference in the least squares means|-1.42||||0.451|2-Sided|95.0|-5.13|2.29||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1636177|NCT01986855|3006900|Superiority or Other||Difference in the least squares means|-1.84|||<|0.001|2-Sided|95.0|-2.66|-1.02||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis||||
1636178|NCT01986855|3006900|Superiority or Other||Difference in the least squares means|-1.77|||<|0.001|2-Sided|95.0|-2.57|-0.96||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable. P-value is nominal.|Constrained longitudinal data analysis||||
1636179|NCT01986855|3006901|Superiority or Other||Difference in the least squares means|-0.09||||0.496|2-Sided|95.0|-0.35|0.17||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1636180|NCT01986855|3006901|Superiority or Other||Difference in the least squares means|-0.03||||0.828|2-Sided|95.0|-0.28|0.23||The cLDA model included fixed effects for treatment, time, baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1636181|NCT01986855|3006902|Superiority or Other||Difference in Percentages vs. Placebo|-1.3|||||2-Sided|95.0|-6.5|3.7|||||Miettinen & Nurminen Method||
1636182|NCT01986855|3006902|Superiority or Other||Difference in Percentages vs. Placebo|3.0|||||2-Sided|95.0|-2.7|9.0|||||Miettinen & Nurminen Method||
1636183|NCT01986855|3006903|Superiority or Other||Difference in Percentages vs. Placebo|-7.0|||||2-Sided|95.0|-16.3|2.3|||||Miettinen & Nurminen Method||
1636184|NCT01986855|3006903|Superiority or Other||Difference in Percentages vs. Placebo|3.6|||||2-Sided|95.0|-4.8|12.1|||||Miettinen & Nurminen Method||
1636185|NCT01986855|3006904|Superiority or Other||Difference in the least squares means|-0.15||||0.155|2-Sided|95.0|-0.35|0.06||The cLDA model included fixed effects for treatment, time, eGFR stratum (<45 or ≥45 mL/min/1.73m^2), baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1636186|NCT01986855|3006904|Superiority or Other||Difference in the least squares means|-0.03||||0.807|2-Sided|95.0|-0.23|0.18||The cLDA model included fixed effects for treatment, time, eGFR stratum (<45 or ≥45 mL/min/1.73m^2), baseline treatment with insulin stratum (yes/no), and the interaction of time by treatment. Time was treated as a categorical variable.|Constrained longitudinal data analysis||||
1636187|NCT01986647|3006932|Superiority or Other||Odds Ratio (OR)|0.52||||0.0324|2-Sided|95.0|0.29|0.95|||Regression, Logistic||||
1636188|NCT01986647|3006933|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.44||0.8|2-Sided||||||Mixed Models Analysis||||
1636189|NCT01986647|3006934|Superiority or Other||Mean Difference (Final Values)|0.001|Standard Error of the Mean|0.004||0.77|2-Sided||||||Mixed Models Analysis||||
1636190|NCT01986647|3006935|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.28||0.71|2-Sided||||||Mixed Models Analysis||||
1636191|NCT01986647|3006936|Superiority or Other||Mean Difference (Final Values)|0.51|Standard Error of the Mean|1.42||0.73|2-Sided||||||Mixed Models Analysis||||
1636192|NCT01986647|3006937|Superiority or Other||Mean Difference (Final Values)|-0.64|Standard Error of the Mean|0.46||0.18|2-Sided||||||Mixed Models Analysis||||
1636193|NCT01986647|3006938|Superiority or Other||Odds Ratio (OR)|1.17||||0.5835|2-Sided|95.0|0.67|2.06|||Regression, Logistic||||
1636194|NCT01986647|3006939|Superiority or Other||Odds Ratio (OR)|1.06||||0.9279|2-Sided|95.0|0.3|3.74|||Regression, Logistic||||
1636195|NCT01986647|3006940|Superiority or Other||Odds Ratio (OR)|3.12||||0.2981|2-Sided|95.0|0.37|26.6|||Regression, Logistic||||
1636196|NCT01986647|3006941|Superiority or Other||Odds Ratio (OR)|1.56||||0.489|2-Sided|95.0|0.44|5.53|||Regression, Logistic||||
1636197|NCT01986647|3006942|Superiority or Other||Risk Difference (RD)|0.88||||0.5719|2-Sided|95.0|0.56|1.37|||Regression, Logistic||||
1636198|NCT01986647|3006943|Superiority or Other||Odds Ratio (OR)|0.89||||0.6879|2-Sided|95.0|0.49|1.6|||Regression, Logistic||||
1636199|NCT01986647|3006944|Superiority or Other|||||||0.0344|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data|||
1636200|NCT01986647|3006945|Superiority or Other|||||||0.0022|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data|||
1636201|NCT01986647|3006946|Superiority or Other|||||||0.6087|||||||Mixed Models Analysis|linear mixed model due to clustering by facility and multiple imputation for missing data|||
1636203|NCT01986101|3006966|Superiority||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.71||0.294|2-Sided|95.0|-2.1|0.7|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.||
1636204|NCT01986101|3006966|Superiority||Mean Difference (Final Values)|-1.7|Standard Error of the Mean|0.7||0.016|2-Sided|95.0|-3.1|-0.3|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.||
1636205|NCT01986101|3006967|Superiority||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.269||0.075|2-Sided|95.0|-1.01|0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.||
1636206|NCT01986101|3006967|Superiority||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.262||0.076|2-Sided|95.0|-0.98|0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.||
1636207|NCT01986101|3006968|Superiority||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.92||0.223|2-Sided|95.0|-2.9|0.7|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.||
1636208|NCT01986101|3006968|Superiority||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|0.89||0.037|2-Sided|95.0|-3.6|-0.1|||ANCOVA||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.||
1636209|NCT01986101|3006969|Superiority||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.13||0.019|2-Sided|95.0|-0.56|-0.05|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in SM-13496 group over the placebo group.||
1636210|NCT01986101|3006969|Superiority||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.127||0.002|2-Sided|95.0|-0.65|-0.15|||Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.||
1636211|NCT01986101|3006970|Superiority||Mean Difference (Final Values)|-2.0|Standard Error of the Mean|1.03||0.057|2-Sided|95.0|-4.0|0.1||Hochberg-adjusted.|Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.||
1636212|NCT01986101|3006970|Superiority||Mean Difference (Final Values)|-2.9|Standard Error of the Mean|1.0||0.007|2-Sided|95.0|-4.9|-1.0||Hochberg-adjusted|Mixed Models Analysis||A negative difference in least square mean change from baseline between SM-13496 group and placebo indicates a greater improvement in the SM-13496 group over the placebo group.||
1636213|NCT01986062|3006971|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1636214|NCT01986062|3006972|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1636215|NCT01986062|3006973|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1636216|NCT01986062|3006974|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1636217|NCT01986062|3006975|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1636218|NCT01986062|3006976|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1636219|NCT01985581|3006994|Superiority or Other||LS mean difference|0.3||||0.8706|2-Sided|95.0|-3.2|3.7|||ANOVA||||
1636220|NCT01985581|3006996|Superiority or Other||LS mean difference|-6.2||||0.0001|2-Sided|95.0|-9.1|-3.2|||ANOVA||||
1636221|NCT01985581|3006997|Superiority or Other||LS mean difference|0.3||||0.894|2-Sided|95.0|-4.0|4.6|||ANOVA||||
1636222|NCT01985581|3006998|Superiority or Other||LS mean difference|-3.0||||0.0392|2-Sided|95.0|-5.9|-0.2|||ANOVA||||
1636223|NCT01985334|3007014|Superiority or Other||||||<|0.0001|||||||linear mixed model||||
1636224|NCT01985334|3007015|Superiority or Other||||||<|0.0001|||||||linear mixed model||||
1636225|NCT01985334|3007016|Non-Inferiority or Equivalence|A difference of 0.6 points in TDI was adopted as boundary for non-inferiority|||||<|0.0001|||||||linear mixed model||||
1636226|NCT01985334|3007017|Superiority or Other||||||<|0.0001|||||||linear mixed model||||
1636227|NCT01985334|3007018|Superiority or Other||||||<|0.0001|||||||linear mixed model||||
1636228|NCT01985334|3007019|Superiority or Other||||||<|0.0001|||||||linear mixed model||||
1636229|NCT01985334|3007020|Non-Inferiority or Equivalence|"H0: Glycopyrronium (50 μg o.d.) [randomized group B2] was inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.~H0: μFEV1, NVA237 – μFEV1, LABA and/or LAMA < -40 mL Ha: Glycopyrronium (50 μg o.d.) [randomized group B2] is non-inferior to LABA or LAMA (random group B1) with respect to mean trough FEV1 after 12 weeks of treatment.~Ha: μFEV1, NVA237 – μFEV1, LABA and/or LAMA ≥ -40 mL"|||||<|0.0001|||||||linear mixed model||||
1636230|NCT01985334|3007021|Superiority or Other|||||||0.018|||||||linear mixed model||||
1636231|NCT01984697|3007038|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.1|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636232|NCT01984697|3007038|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636233|NCT01984697|3007038|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636234|NCT01984697|3007039|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636235|NCT01984697|3007039|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636236|NCT01984697|3007039|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.0|||<|0.001|2-Sided|95.0|-1.7|1.7|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636237|NCT01984697|3007040|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|2.1|||<|0.001|2-Sided|95.0|0.7|4.6|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636238|NCT01984697|3007040|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|1.4|||<|0.001|2-Sided|95.0|-0.7|4.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636239|NCT01984697|3007040|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|1.4|||<|0.001|2-Sided|95.0|-0.7|4.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636240|NCT01984697|3007041|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.1|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636241|NCT01984697|3007041|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.0|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636242|NCT01984697|3007041|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.0|||<|0.001|2-Sided|95.0|-1.7|1.7|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636243|NCT01984697|3007042|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636244|NCT01984697|3007042|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.0|2.1|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636245|NCT01984697|3007042|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.0|||<|0.001|2-Sided|95.0|-1.7|1.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636246|NCT01984697|3007043|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|1.5|||<|0.001|2-Sided|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636247|NCT01984697|3007043|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|1.5|||<|0.001|2-Sided|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636248|NCT01984697|3007043|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|1.5|||<|0.001|2-Sided|95.0|0.1|3.8|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636249|NCT01984697|3007044|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636250|NCT01984697|3007044|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636251|NCT01984697|3007044|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.0|2.2|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636252|NCT01984697|3007045|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636253|NCT01984697|3007045|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.0|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636254|NCT01984697|3007045|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636255|NCT01984697|3007046|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|4.98|||<|0.001|2-Sided|95.0|4.23|5.86|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636256|NCT01984697|3007046|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|2.7|||<|0.001|2-Sided|95.0|2.3|3.16|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636257|NCT01984697|3007046|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT ratio|2.55|||<|0.001|2-Sided|95.0|2.15|3.01|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636258|NCT01984697|3007047|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|3.08|||<|0.001|2-Sided|95.0|2.64|3.61|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636259|NCT01984697|3007047|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|1.76|||<|0.001|2-Sided|95.0|1.51|2.05|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636260|NCT01984697|3007047|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT ratio|1.6|||<|0.001|2-Sided|95.0|1.36|1.87|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636261|NCT01984697|3007048|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|1.96|||<|0.001|2-Sided|95.0|1.61|2.37|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636262|NCT01984697|3007048|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|1.65|||<|0.001|2-Sided|95.0|1.37|1.99|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636263|NCT01984697|3007048|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT ratio|1.67|||<|0.001|2-Sided|95.0|1.38|2.03|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636264|NCT01984697|3007049|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|6.31|||<|0.001|2-Sided|95.0|5.36|7.43|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636265|NCT01984697|3007049|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|2.99|||<|0.001|2-Sided|95.0|2.55|3.5|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636266|NCT01984697|3007049|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT ratio|2.96|||<|0.001|2-Sided|95.0|2.5|3.5|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636267|NCT01984697|3007050|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|3.7|||<|0.001|2-Sided|95.0|3.08|4.45|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636268|NCT01984697|3007050|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|2.62|||<|0.001|2-Sided|95.0|2.2|3.12|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636269|NCT01984697|3007050|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT ratio|2.51|||<|0.001|2-Sided|95.0|2.1|3.0|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636270|NCT01984697|3007051|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|3.69|||<|0.001|2-Sided|95.0|3.06|4.45|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636271|NCT01984697|3007051|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|2.44|||<|0.001|2-Sided|95.0|2.04|2.92|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636409|NCT01981954|3007299|Other|||||||0.688||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636272|NCT01984697|3007051|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT ratio|2.46|||<|0.001|2-Sided|95.0|2.05|2.96|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636273|NCT01984697|3007052|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|4.54|||<|0.001|2-Sided|95.0|3.84|5.37|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636274|NCT01984697|3007052|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|2.69|||<|0.001|2-Sided|95.0|2.29|3.15|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636275|NCT01984697|3007052|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT ratio|2.54|||<|0.001|2-Sided|95.0|2.14|3.0|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636276|NCT01984697|3007053|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|5.07|||<|0.001|2-Sided|95.0|4.32|5.94|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636277|NCT01984697|3007053|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|2.45|||<|0.001|2-Sided|95.0|2.09|2.88|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636278|NCT01984697|3007053|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT ratio|2.39|||<|0.001|2-Sided|95.0|2.03|2.82|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636279|NCT01984697|3007054|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls and Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.1|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636280|NCT01984697|3007054|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Boys 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.4|||<|0.001|2-Sided|95.0|-1.0|2.3|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636281|NCT01984697|3007054|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the seroconversion percentage difference for Girls 9 to 14 Years - Young Women 16 to 26 years is > -5.|Seroconversion percentage difference|0.0|||<|0.001|2-Sided|95.0|-1.8|2.0|||Miettinen and Nurminen|One-sided non-inferiority test at alpha=0.025 level|||
1636282|NCT01984697|3007055|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Girls and Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|3.47|||<|0.001|2-Sided|95.0|2.93|4.11|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636283|NCT01984697|3007055|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the GMT ratio for Boys 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT Ratio|2.02|||<|0.001|2-Sided|95.0|1.73|2.36|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636284|NCT01984697|3007055|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the 95% confidence interval of the Geometric Mean Titer (GMT) ratio for Girls 9 to 14 Years / Young Women 16 to 26 years is >0.67.|GMT ratio|2.15|||<|0.001|2-Sided|95.0|1.83|2.53|||ANOVA|One-sided non-inferiority test at alpha=0.025 level|||
1636285|NCT01984684|3007056|Non-Inferiority|Analysis of the investigator's assessment of response (cure only) at the Late Follow-up Visit was assessed using the Miettinen-Nurminen method without stratification.|Difference in Cure Rates|-3.1|||||2-Sided|95.0|-9.3|3.1|||||||
1636286|NCT01984684|3007057|Non-Inferiority|Analysis of the investigator's assessment of response of signs and symptoms of infection (cure only) was performed using the Miettinen-Nurminen method without stratification for the ITT analysis set.|Difference in Cure Rates|-2.0|||||2-Sided|95.0|-8.6|4.6|||||||
1636287|NCT01984684|3007058|Non-Inferiority|A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in responder rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.|Difference in Responder Rates|3.1|||||2-Sided|95.0|-2.0|8.3|||||||
1636288|NCT01984424|3007062|Superiority||LS Mean Treatment Difference|-1.23|Standard Error of the Mean|4.67||0.37|2-Sided|95.0|-10.45|7.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636289|NCT01984424|3007063|Superiority||LS Mean Treatment Difference|-4.65|Standard Error of the Mean|3.85||0.37|2-Sided|95.0|-12.25|2.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636290|NCT01984424|3007064|Superiority||LS Mean Treatment Difference|4.5|Standard Error of the Mean|2.27||0.0083|2-Sided|95.0|0.02|8.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636291|NCT01984424|3007065|Superiority||LS Mean Treatment Difference|6.18|Standard Error of the Mean|2.05||0.0083|2-Sided|95.0|2.15|10.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636292|NCT01984424|3007066|Superiority||LS Mean Treatment Difference|-1.82|Standard Error of the Mean|6.0||0.37|2-Sided|95.0|-13.64|10.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636293|NCT01984424|3007067|Superiority||LS Mean Treatment Difference|-4.44|Standard Error of the Mean|4.72||0.37|2-Sided|95.0|-13.74|4.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636294|NCT01984424|3007068|Superiority||LS Mean Treatment Difference|-21.24|Standard Error of the Mean|3.64|<|0.0001|2-Sided|95.0|-28.42|-14.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636295|NCT01984424|3007069|Superiority||LS Mean Treatment Difference|-21.08|Standard Error of the Mean|3.33|<|0.0001|2-Sided|95.0|-27.65|-14.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636296|NCT01984424|3007070|Superiority||LS Mean Treatment Difference|-31.98|Standard Error of the Mean|2.36|<|0.0001|2-Sided|95.0|-36.64|-27.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636297|NCT01984424|3007071|Superiority||LS Mean Treatment Difference|-34.13|Standard Error of the Mean|2.26|<|0.0001|2-Sided|95.0|-38.59|-29.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636298|NCT01984424|3007072|Superiority||LS Mean Treatment Difference|-27.2|Standard Error of the Mean|2.22|<|0.0001|2-Sided|95.0|-31.58|-22.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636299|NCT01984424|3007073|Superiority||LS Mean Treatment Difference|-29.91|Standard Error of the Mean|2.1|<|0.0001|2-Sided|95.0|-34.06|-25.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636300|NCT01984424|3007074|Superiority||LS Mean Treatment Difference|-31.75|Standard Error of the Mean|2.33|<|0.0001|2-Sided|95.0|-36.35|-27.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636301|NCT01984424|3007075|Superiority||LS Mean Treatment Difference|-33.86|Standard Error of the Mean|2.17|<|0.0001|2-Sided|95.0|-38.15|-29.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636302|NCT01984424|3007076|Superiority||LS Mean Treatment Difference|-31.1|Standard Error of the Mean|2.2|<|0.0001|2-Sided|95.0|-35.44|-16.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636303|NCT01984424|3007077|Superiority||LS Mean Treatment Difference|-33.06|Standard Error of the Mean|2.06|<|0.0001|2-Sided|95.0|-37.12|-28.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636304|NCT01984424|3007078|Superiority||LS Mean Treatment Difference|-25.08|Standard Error of the Mean|1.82|<|0.0001|2-Sided|95.0|-28.67|-21.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636305|NCT01984424|3007079|Superiority||LS Mean Treatment Difference|-26.61|Standard Error of the Mean|1.69|<|0.0001|2-Sided|95.0|-29.95|-23.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636306|NCT01984424|3007080|Superiority||Treatment Difference|27.4|||<|0.0001|2-Sided|95.0|17.7|36.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (screening LDL-C).|||
1636307|NCT01984424|3007081|Superiority||Treatment Difference|28.5|||<|0.0001|2-Sided|95.0|19.1|36.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (screening LDL-C).|||
1636308|NCT01984424|3007082|Superiority||LS Mean Treatment Difference|-71.7|Standard Error of the Mean|4.8|<|0.0001|2-Sided|95.0|-81.3|-62.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636309|NCT01984424|3007083|Superiority||LS Mean Treatment Difference|-75.8|Standard Error of the Mean|4.5|<|0.0001|2-Sided|95.0|-84.7|-67.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.|||
1636410|NCT01981954|3007316|Other|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636583|NCT01976988|3007740|Superiority or Other|||||||0.03|||||||Fisher Exact||||
1636310|NCT01984424|3007084|Superiority||LS Mean Treatment Difference|-36.07|Standard Error of the Mean|2.53|<|0.0001|2-Sided|95.0|-41.07|-31.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from baseline at week 24 of part B or in the mean percent change from baseline at weeks 22 and 24 of part B in LDL-C between evolocumab 420 mg and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1636311|NCT01984424|3007085|Superiority|Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|LS Mean Treatment Difference|-37.79|Standard Error of the Mean|2.29|<|0.0001|2-Sided|95.0|-42.31|-33.28|||Repeated Measures Model|Model includes treatment group, stratification factor (screening LDL-C), scheduled visit and interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from baseline at week 24 of part B or in the mean percent change from baseline at weeks 22 and 24 of part B in LDL-C between evolocumab 420 mg and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1636312|NCT01984242|3007105|Superiority||Hazard Ratio (HR)|0.96||||0.9065|2-Sided|95.0|0.52|1.8|||Log Rank||||
1636313|NCT01984242|3007105|Superiority||Hazard Ratio (HR)|0.91||||0.7879|2-Sided|95.0|0.47|1.78|||Log Rank||||
1636314|NCT01984242|3007107|Superiority||Hazard Ratio (HR)|1.06||||0.8039||95.0|0.65|1.73|||Log Rank||||
1636315|NCT01984242|3007107|Superiority||Hazard Ratio (HR)|1.3||||0.2867|2-Sided|95.0|0.8|2.13|||Log Rank||||
1636316|NCT01984242|3007115|Superiority||Hazard Ratio (HR)|0.9||||0.6566|2-Sided|95.0|0.56|1.44|||Log Rank||||
1636317|NCT01984242|3007115|Superiority||Hazard Ratio (HR)|0.43||||0.0021||95.0|0.25|0.75|||Log Rank||||
1636318|NCT01984242|3007117|Superiority||Hazard Ratio (HR)|1.1||||0.5922|2-Sided|95.0|0.77|1.57|||Log Rank||||
1636319|NCT01984242|3007117|Superiority||Hazard Ratio (HR)|0.72||||0.0863||95.0|0.5|1.05|||Log Rank||||
1636320|NCT01984242|3007119|Superiority||Difference in response rates|-2.22||||0.8209|2-Sided|95.0|-20.63|16.19|||Cochran-Mantel-Haenszel||||
1636321|NCT01984242|3007119|Superiority||Difference in response rates|22.0||||0.0111|2-Sided|95.0|2.11|41.89|||Cochran-Mantel-Haenszel||||
1636322|NCT01984242|3007120|Superiority||Difference in response rates|-8.42||||0.1816|2-Sided|95.0|-21.86|5.02|||Cochran-Mantel-Haenszel||||
1636323|NCT01984242|3007120|Superiority||Difference in response rates|3.96||||0.6231|2-Sided|95.0|-10.23|18.15|||Cochran-Mantel-Haenszel||||
1636324|NCT01984242|3007121|Superiority||Difference in response rates|-2.41||||0.7836|2-Sided|95.0|-20.5|15.68|||Cochran-Mantel-Haenszel||||
1636325|NCT01984242|3007121|Superiority||Difference in response rates|19.67||||0.0199|2-Sided|95.0|-0.1|39.44|||Cochran-Mantel-Haenszel||||
1636326|NCT01984242|3007122|Superiority||Difference in response rates|-9.37||||0.1321||95.0|-22.61|3.87|||Cochran-Mantel-Haenszel||||
1636327|NCT01984242|3007122|Superiority||Difference in response rates|1.98||||0.8068|2-Sided|95.0|-12.04|16.0|||Cochran-Mantel-Haenszel||||
1636328|NCT01984242|3007123|Superiority||Difference in response rates|1.11||||0.8719|2-Sided|95.0|-17.02|19.24|||Cochran-Mantel-Haenszel||||
1636329|NCT01984242|3007123|Superiority||Difference in response rates|19.33||||0.0141|2-Sided|95.0|-0.28|38.94|||Cochran-Mantel-Haenszel||||
1636330|NCT01984242|3007124|Superiority||Difference in response rates|-3.47||||0.5433||95.0|-16.63|9.69|||Cochran-Mantel-Haenszel||||
1636331|NCT01984242|3007124|Superiority||Difference in response rates|2.97||||0.6492|2-Sided|95.0|-10.68|16.62|||Cochran-Mantel-Haenszel||||
1636332|NCT01984242|3007125|Superiority||Hazard Ratio (HR)|0.99||||0.9769||95.0|0.64|1.54|||Log Rank||||
1636333|NCT01984242|3007125|Superiority||Hazard Ratio (HR)|0.6||||0.0351|2-Sided|95.0|0.37|0.97|||Log Rank||||
1636334|NCT01984242|3007127|Superiority||Hazard Ratio (HR)|1.18||||0.3103|2-Sided|95.0|0.86|1.63|||Log Rank||||
1636335|NCT01984242|3007127|Superiority||Hazard Ratio (HR)|0.82||||0.2541||95.0|0.59|1.15|||Log Rank||||
1636336|NCT01984242|3007129|Superiority||Hazard Ratio (HR)|1.09||||0.7141|2-Sided|95.0|0.7|1.69|||Log Rank||||
1636337|NCT01984242|3007129|Superiority||Hazard Ratio (HR)|0.68||||0.083||95.0|0.43|1.06|||Log Rank||||
1636338|NCT01984242|3007131|Superiority||Hazard Ratio (HR)|1.07||||0.7738|2-Sided|95.0|0.65|1.76|||Log Rank||||
1636339|NCT01984242|3007131|Superiority||Hazard Ratio (HR)|0.72||||0.1973||95.0|0.44|1.18|||Log Rank||||
1636340|NCT01984242|3007133|Superiority||Hazard Ratio (HR)|0.93||||0.7675||95.0|0.56|1.53|||Log Rank||||
1636341|NCT01984242|3007133|Superiority||Hazard Ratio (HR)|0.49||||0.0086|2-Sided|95.0|0.28|0.84|||Log Rank||||
1636342|NCT01984242|3007135|Superiority||Hazard Ratio (HR)|0.84||||0.5545|2-Sided|95.0|0.48|1.46|||Log Rank||||
1636343|NCT01984242|3007135|Superiority||Hazard Ratio (HR)|0.48||||0.0153|2-Sided|95.0|0.26|0.87|||Log Rank||||
1636344|NCT01984242|3007137|Superiority||Hazard Ratio (HR)|1.03||||0.9172|2-Sided|95.0|0.63|1.67|||Log Rank||||
1636345|NCT01984242|3007137|Superiority||Hazard Ratio (HR)|0.64||||0.0952||95.0|0.38|1.08|||Log Rank||||
1636346|NCT01984242|3007139|Superiority||Hazard Ratio (HR)|1.19||||0.358|2-Sided|95.0|0.82|1.71|||Log Rank||||
1636347|NCT01984242|3007139|Superiority||Hazard Ratio (HR)|1.0||||0.9819|2-Sided|95.0|0.69|1.45|||Log Rank||||
1636348|NCT01984229|3007151|Superiority or Other||Geometric Least Square Mean Ratio|75.1|||||2-Sided|90.0|64.4|87.7|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.|
1636349|NCT01984229|3007152|Superiority or Other||Geometric Least Square Mean Ratio|66.2|||||2-Sided|90.0|56.7|77.4|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.|
1636584|NCT01976988|3007741|Superiority or Other|||||||0.36|||||||Fisher Exact||||
1636350|NCT01984229|3007153|Superiority or Other||Geometric Least Square Mean Ratio|28.7|||||2-Sided|90.0|23.1|35.5|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.|
1636351|NCT01984229|3007157|Superiority or Other||Geometric Least Square Mean Ratio|175.0|||||2-Sided|90.0|157.0|195.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.|
1636352|NCT01984229|3007158|Superiority or Other||Geometric Least Square Mean Ratio|177.0|||||2-Sided|90.0|159.0|198.0|||||The reported values are percentages of geometric least square mean ratio.|ANOVA was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and CIs.|
1636353|NCT01984229|3007159|Superiority or Other||Geometric Least Square Mean Ratio|118.0|||||2-Sided|90.0|102.0|137.0|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameter and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals (CIs).|
1636354|NCT01983683|3007185|Superiority|Sensitivity analysis|Difference between 2 proportions|2.7|||||2-Sided|95.0|-5.5|10.9|||||CI for the difference between two proportions are estimated using the Wilson's score method||
1636355|NCT01983683|3007186|Other||Difference between 2 proportions|8.8|||||2-Sided|95.0|1.1|16.4|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis|
1636356|NCT01983683|3007187|Other||Difference between 2 proportions|-1.6|||||2-Sided|95.0|-6.5|3.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis|
1636357|NCT01983683|3007188|Other||Difference between 2 proportions|-1.1|||||2-Sided|95.0|-6.5|4.2|||||CI for the difference between two proportions are estimated using the Wilson's score method|Exploratory analysis|
1636358|NCT01983683|3007189|Superiority||Least Square Mean difference|0.061||||0.4145|2-Sided|95.0|-0.09|0.21||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the other symptoms domain scores|
1636359|NCT01983683|3007189|Superiority||Least Square Mean difference|0.025||||0.7833|2-Sided|95.0|-0.15|0.2||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the abdominal symptoms domain scores|
1636360|NCT01983683|3007189|Superiority||Least Square Mean difference|-0.044||||0.6871|2-Sided|95.0|-0.26|0.17||Two-sided 5% alpha level was used|ANOVA|ANOVA model for repeated measurements was fitted using all values from Day 1 (baseline) to Day 12.|The Least Square Means of the treatments differences for the changes from baseline at Day 3 were obtained using estimate statements|Comparison of the diarrhea domain scores|
1636361|NCT01983683|3007190|Superiority||Hazard Ratio (HR)|1.04||||0.7794|2-Sided|95.0|0.86|1.24||two-sided p-value (alpha 5%) based on log-rank test stratified by first occurrence / first recurrence and geographical region.|Log Rank||||
1636362|NCT01983683|3007191|Superiority|Superiority of cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above zero|Difference between 2 proportions|1.7|||||2-Sided|95.0|-6.1|9.4|||||CI for the difference between two proportions are estimated using the Wilson's score method||
1636363|NCT01983683|3007192|Non-Inferiority|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above –10%|Difference between 2 proportions|-4.9|||||2-Sided|95.0|-10.4|0.6|||||CI for the difference between two proportions are estimated using the Wilson' score method||
1636364|NCT01983683|3007193|Non-Inferiority|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above –10%|Difference between 2 proportions|-3.6|||||2-Sided|95.0|-9.6|2.3|||||CI for the difference between two proportions are estimated using the Wilson's score method|Sensitivity analysis with imputation for a single day with missing UBM data between one day before end-of-treatment (EOT) and 2 days after EOT|
1636365|NCT01983683|3007193|Non-Inferiority|Non-inferiority of CCR for cadazolid versus vancomycin is demonstrated if the lower limit of the 95% confidence interval (CI) is above –10%|Difference between 2 proportions|-4.7|||||2-Sided|95.0|-10.7|1.3|||||CI for the difference between two proportions are estimated using the Wilson's score method||
1636366|NCT01983566|3007195|Non-Inferiority or Equivalence|The actual number of subjects analyzed is 16. No formal statistical hypothesis was tested.|Geometric mean ratio (%)|114.83||||0.3674|2-Sided|90.0|74.803|176.281||The p-value relates to the null hypothesis of non-equivalence (bioequivalence test). P-value for ratio outside interval 80-125%.|ANOVA||This model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'. The statistical analysis result is based on the adjusted means.|"The difference between the expected means for log(Dele low fat) and log(Dele fasted) was estimated by the differences in the adjusted means (Least Squares Means), and a 2 sided 90% CI based on the t-distribution was computed.~These were then back transformed. This estimation model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'."|
1636367|NCT01983566|3007196|Non-Inferiority or Equivalence|The actual number of subjects analyzed is 16. No formal statistical hypothesis was tested.|Geometric mean ratio (%)|115.8||||0.3944|2-Sided|90.0|63.52|211.11||The p-value relates to the null hypothesis of non-equivalence (bioequivalence test). P-value for ratio outside interval 80-125%.|ANOVA||This model included effects accounting for the following sources of variation: ‘sequence’, ‘subjects within sequence’, ‘period’, and ‘treatment’. The statistical analysis result is based on the adjusted means.|"The difference between the expected means for log(Dele low fat) and log(Dele fasted) was estimated by the differences in the adjusted means (Least Squares Means), and a 2 sided 90% confidence interval (CI) based on the t-distribution was computed.~These were then back transformed. The estimation model included effects accounting for the following sources of variation: 'sequence', 'subjects within sequence', 'period', and 'treatment'."|
1636585|NCT01976988|3007742|Superiority or Other|||||||0.72|||||||Fisher Exact||||
1636368|NCT01983553|3007199|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade II between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||2-Sided|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Grade II|
1636369|NCT01983553|3007199|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.0|||||2-Sided|95.0|0.0|19.62|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Grade I|
1636370|NCT01983553|3007199|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.252|||||2-Sided|95.0|0.0|4.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 4; Any grade|
1636371|NCT01983553|3007199|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||2-Sided|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 2; Grade I|
1636372|NCT01983553|3007199|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.503|||||2-Sided|95.0|0.01|39.49|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Serotype 2; Any grade|
1636373|NCT01983553|3007199|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes Grade II between the CYD Dengue vaccine group and the Control group.|Relative Risk|2.012|||||2-Sided|95.0|0.2|99.1|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Grade II|
1636374|NCT01983553|3007199|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Grade I between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.252|||||2-Sided|95.0|0.0|4.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Grade I|
1636375|NCT01983553|3007199|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes; Any grade between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.174|||||2-Sided|95.0|0.27|7.03|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; Any serotype; Any grade|
1636376|NCT01983553|3007207|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.0|||||2-Sided|95.0|0.0|19.75|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Unserotyped|
1636377|NCT01983553|3007207|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|0.0|||||2-Sided|95.0|0.0|2.6|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Unserotyped|
1636378|NCT01983553|3007207|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.506|||||2-Sided|95.0|0.18|1.44|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 4|
1636379|NCT01983553|3007207|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|0.977|||||2-Sided|95.0|0.21|6.04|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 4|
1636380|NCT01983553|3007207|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|1.013|||||2-Sided|95.0|0.41|2.73|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 3|
1636381|NCT01983553|3007207|Other|Relative risk analysis of the event rate per 100 participants at Year 1 for Serotype 3 (4 to 5 year) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|1.221|||||2-Sided|95.0|0.2|12.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 3|
1636382|NCT01983553|3007207|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|1.165|||||2-Sided|95.0|0.53|2.74|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 2|
1636383|NCT01983553|3007207|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|2.931|||||2-Sided|95.0|0.36|134.83|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 2|
1636411|NCT01981954|3007317|Other|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636412|NCT01981954|3007318|Other|||||||0.004||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636384|NCT01983553|3007207|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.557|||||2-Sided|95.0|0.21|1.46|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Serotype 1|
1636385|NCT01983553|3007207|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|4.885|||||2-Sided|95.0|0.7|212.02|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Serotype 1|
1636386|NCT01983553|3007207|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (6 to 11 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 2618 instead of 3203.|Relative Risk|0.807|||||2-Sided|95.0|0.53|1.25|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 6 to 11 years; Any Serotype|
1636387|NCT01983553|3007207|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes (4 to 5 years) between the CYD Dengue vaccine group and the Control group. Total number of participants analyzed were 585 instead of 3203.|Relative Risk|1.411|||||2-Sided|95.0|0.64|3.42|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative Risk; 4 to 5 years; Any Serotype|
1636388|NCT01983553|3007210|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Unserotyped between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.0|||||2-Sided|95.0|0.0|1.22|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Unserotyped|
1636389|NCT01983553|3007210|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 4 between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.629|||||2-Sided|95.0|0.27|1.47|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 4|
1636390|NCT01983553|3007210|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 3 between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.056|||||2-Sided|95.0|0.48|2.51|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 3|
1636391|NCT01983553|3007210|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 2 between the CYD Dengue vaccine group and the Control group.|Relative Risk|1.326|||||2-Sided|95.0|0.64|2.94|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 2|
1636392|NCT01983553|3007210|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Serotype 1 between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.96|||||2-Sided|95.0|0.44|2.21|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Serotype 1|
1636393|NCT01983553|3007210|Other|Relative risk analysis of the event rate per 100 participants during Year 1 to Year 4 for Any of the 4 Serotypes between the CYD Dengue vaccine group and the Control group.|Relative Risk|0.93|||||2-Sided|95.0|0.64|1.36|||||The 95% confidence interval of the relative risk was calculated using the Exact method described by Breslow and Day.|Relative risk; Any of the 4 Serotypes|
1636394|NCT01983293|3007211|Superiority|||||||0.001|||||||Fisher Exact||||
1636395|NCT01983111|3007220|Non-Inferiority or Equivalence|In the PP set, for a non-inferiority test of the reduction in the pain intensity score from Visit 1 (Baseline) to Week 6 of treatment, the lower limit of the 97.5% onesided confidence interval was compared to a clinical non-inferiority margin, -1.5.|Mean Difference (Final Values)|-0.43|Standard Deviation|1.79||0.2658|2-Sided|97.5|-6.0|3.0|||t-test, 2 sided|||In the Per protocol set|
1636396|NCT01982435|3007251|Other|Measures were summarized using means, range and standard error of the means (SEM).|||||<|0.05||||||Two-sided paired t-tests and two-sided unpaired t-tests were respectively conducted to analyze efficacy endpoints between study initiation to end, and between monthly and TAE injection regimens.|t-test, 2 sided|||All analyses were performed with a significance level of 0.05 being assumed for all tests.|
1636397|NCT01982292|3007276|Superiority or Other||Difference in percentage|-0.5|||||2-Sided|90.0|-10.38|9.38||||||Difference in percentage of patients with negative antibody status|
1636398|NCT01982292|3007276|Superiority or Other||Difference in percentage|0.5|||>|0.9999|2-Sided|90.0|-9.38|10.38|||Fisher Exact|||Difference in percentage of patients with positive antibody status|
1636399|NCT01981954|3007289|Other|||||||0.721||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636400|NCT01981954|3007290|Other|||||||0.031||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636401|NCT01981954|3007291|Other|||||||0.575||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|t-test, 2 sided|||Week 24 Analysis|
1636402|NCT01981954|3007292|Other|||||||1||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636403|NCT01981954|3007293|Other|||||||0.94||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636404|NCT01981954|3007294|Other|||||||0.41||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636405|NCT01981954|3007295|Other|||||||0.631||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636406|NCT01981954|3007296|Other|||||||0.657||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636407|NCT01981954|3007297|Other|||||||0.562||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636413|NCT01981954|3007319|Other||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636414|NCT01981954|3007320|Other|||||||0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636415|NCT01981954|3007321|Other|||||||0.567||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636416|NCT01981954|3007322|Other|||||||0.05||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636417|NCT01981954|3007323|Other|||||||0.025||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analyis|
1636418|NCT01981954|3007324|Other|||||||0.177||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636419|NCT01981954|3007325|Other||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636420|NCT01981954|3007326|Other|||||||0.352||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636421|NCT01981954|3007327|Other|||||||0.744||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 Analysis|
1636422|NCT01981954|3007328|Other|||||||0.003||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline=0.|t-test, 2 sided|||Week 24 Analysis|
1636423|NCT01981954|3007330|Other||||||<|0.001||||||From a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|t-test, 2 sided|||Week 24 MCC Analysis|
1636424|NCT01981863|3007331|Superiority or Other|||||||0.21|||||||t-test, 2 sided||||
1636425|NCT01981616|3007339|Non-Inferiority or Equivalence|The sample size of 55 evaluable subjects in the vedolizumab 750 mg IV group and 55 evaluable participants in the placebo group provided at least 71% power to exclude the non-inferiority margin of 15% with the lower bound of the 1-sided 95% CI on the difference in proportions between vedolizumab- and placebo-treated participants, assuming an 85% seroconversion rate to the oral cholera vaccine (Dukoral).|Difference from placebo|-14.2|||||2-Sided|95.0|-24.6|-3.9|||||||
1636426|NCT01981616|3007340|Non-Inferiority or Equivalence|"With 55 evaluable participants in each group, the study would have at least 80% power to exclude the non-inferiority margin of 15% with the lower bound of the 1-sided 95% confidence interval (CI) on the difference in proportions between vedolizumab- and placebo-treated participants, assuming a 90% seroconversion rate (anti-HBs of 10 IU/L) for hepatitis B vaccine.~If the lower bound of this interval was less than -15% (ie, more negative), then the null hypothesis was accepted."|Difference from placebo|-1.8|||||2-Sided|95.0|-12.7|9.1|||||||
1636427|NCT01981564|3007346|Superiority|||||||0.06|||||||ANOVA|||ANOVA F=3.55, df=1, p=0.06|
1636428|NCT01981473|3007362|Superiority or Other||||||<|0.0001||||||As there was only one primary endpoint, no adjustment was made for multiple comparisons.|Fisher Exact|Logistic regression was to be used but the model was not fit as there were no antibodies in the etanercept group. Fisher’s exact test was used.||This sample was to provide >95% power to detect a difference of 12% in the proportion of participants positive for antidrug antibodies between the group of participants treated with a soluble receptor TNF inhibitor (etanercept) and the group of participants treated with mAB TNF inhibitors (adalimumab and infliximab) (5% vs 17%, respectively), using a Chi square test with continuity correction, an alpha of 0.05, and attrition rate of 15%.|
1636429|NCT01981122|3007374|Superiority|||||||0.095|||||||Mixed Models Analysis|Repeated Measures|||
1636430|NCT01981096|3007377|Superiority|||||||0.055||||||The a priori threshold was alpha = .05.|ANCOVA|Adjusted for age and baseline pain levels||This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.|
1636431|NCT01981096|3007378|Superiority|||||||0.011||||||The a priori threshold was alpha = .05.|ANCOVA|Adjusted for age and baseline pain levels||This analysis represents the between group comparisons (i.e., FIT Teens vs. CBT) from baseline assessment to the 3-month follow-up, the primary endpoint of the trial.|
1636432|NCT01980940|3007396|Superiority or Other|||||||0.315|||||||Jonckheere-Terpstra test|||Treatment comparison of post-trial PGART frequencies (ETOR 50 DMSO vs Placebo [Pt 2]) was performed using a two-sided Jonckheere-Terpstra test.|
1636433|NCT01980940|3007396|Superiority or Other|||||||0.6626|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 14 PGART frequencies (ETOR 50 DMSO vs Placebo [Pt 2]) was performed using a two-sided Jonckheere-Terpstra test.|
1636434|NCT01980940|3007396|Superiority or Other|||||||0.3992|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 11 PGART frequencies (ETOR 50 DMSO vs Placebo [Pt 2]) was performed using a two-sided Jonckheere-Terpstra test.|
1636435|NCT01980940|3007396|Superiority or Other|||||||0.5507|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 7 PGART frequencies (ETOR 50 DMSO vs Placebo [Pt 2]) was performed using a two-sided Jonckheere-Terpstra test.|
1636436|NCT01980940|3007396|Superiority or Other|||||||0.4703|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 4 PGART frequencies (ETOR 50 DMSO vs Placebo [Pt 2]) was performed using a two-sided Jonckheere-Terpstra test.|
1636437|NCT01980940|3007396|Superiority or Other|||||||0.2632|||||||Jonckheere-Terpstra test|||Treatment comparison of Day 2 PGART frequencies (ETOR 50 DMSO vs Placebo [Pt 2]) was performed using a two-sided Jonckheere-Terpstra test.|
1636438|NCT01980940|3007397|Superiority or Other||Mean Difference (Final Values)|-42.0|Standard Error of the Mean|63.7||0.5125|2-Sided|90.0|-149.0|64.9|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636470|NCT01979952|3007454|Superiority or Other||Adjusted mean difference|4.89|||||2-Sided|95.0|-1.47|11.25||||||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation|
1638253|NCT01948310|3011458|Superiority||||||>|0.05|||||||t-test, 2 sided|||14-0 weeks|
1636439|NCT01980940|3007397|Superiority or Other||Mean Difference (Final Values)|-42.3|Standard Error of the Mean|62.49||0.5022|2-Sided|90.0|-147.2|62.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636440|NCT01980940|3007397|Superiority or Other||Mean Difference (Final Values)|-35.2|Standard Error of the Mean|65.25||0.5926|2-Sided|90.0|-144.7|74.4|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636441|NCT01980940|3007397|Superiority or Other||Mean Difference (Final Values)|-33.7|Standard Error of the Mean|65.42||0.6084|2-Sided|90.0|-143.6|76.1|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636442|NCT01980940|3007397|Superiority or Other||Mean Difference (Final Values)|-52.3|Standard Error of the Mean|68.25||0.4477|2-Sided|90.0|-166.8|62.3|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 physical function subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636443|NCT01980940|3007398|Superiority or Other||Mean Difference (Final Values)|-7.1|Standard Error of the Mean|8.19||0.3881|2-Sided|90.0|-20.9|6.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636444|NCT01980940|3007398|Superiority or Other||Mean Difference (Final Values)|-8.1|Standard Error of the Mean|8.15||0.3246|2-Sided|90.0|-21.8|5.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636445|NCT01980940|3007398|Superiority or Other||Mean Difference (Final Values)|-9.5|Standard Error of the Mean|8.53||0.2691|2-Sided|90.0|-23.9|4.8|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636446|NCT01980940|3007398|Superiority or Other||Mean Difference (Final Values)|-10.4|Standard Error of the Mean|8.66||0.238|2-Sided|90.0|-24.9|4.2|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636447|NCT01980940|3007398|Superiority or Other||Mean Difference (Final Values)|-14.1|Standard Error of the Mean|9.32||0.1383|2-Sided|90.0|-29.7|1.6|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 stiffness subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636448|NCT01980940|3007399|Superiority or Other||Mean Difference (Final Values)|-17.3|Standard Error of the Mean|19.81||0.3883|2-Sided|90.0|-50.5|16.0|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 14 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 14 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636449|NCT01980940|3007399|Superiority or Other||Median Difference (Final Values)|-17.6|Standard Error of the Mean|19.52||0.3709|2-Sided|90.0|-50.4|15.1|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 11 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 11 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636450|NCT01980940|3007399|Superiority or Other||Mean Difference (Final Values)|-21.4|Standard Error of the Mean|19.94||0.288|2-Sided|90.0|-54.9|12.0|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 7 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 7 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636471|NCT01979952|3007455|Superiority or Other||Adjusted mean difference|17.94|Standard Error of the Mean|16.19|||2-Sided|95.0|-14.21|50.09||||||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation|
1638254|NCT01948310|3011458|Superiority||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks|
1636451|NCT01980940|3007399|Superiority or Other||Mean Difference (Final Values)|-22.7|Standard Error of the Mean|19.66||0.2548|2-Sided|90.0|-55.7|10.3|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 4 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 4 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636452|NCT01980940|3007399|Superiority or Other||Mean Difference (Final Values)|-27.3|Standard Error of the Mean|21.57||0.2113|2-Sided|90.0|-63.6|8.9|||constrained longitudinal data analysis|||Treatment difference in mean time-weighted average change from baseline to Day 2 in the WOMAC VA 3.1 pain subscale score (ETOR 50 DMSO - Placebo [Pt 2]) was evaluated using a constrained longitudinal data analysis model that included baseline measurements and time-weighted average at Day 2 in the response variable. The model included terms of visit, visit-by-treatment, and treatment.|
1636453|NCT01980940|3007400|Superiority or Other||Treatment ratio|0.41|||||2-Sided|90.0|0.21|0.79||||||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the dose comparison (ETOR 75 PG/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|
1636454|NCT01980940|3007400|Superiority or Other||Treatment ratio|0.47|||||2-Sided|90.0|0.39|0.57||||||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the dose comparison (ETOR 75 DMSO/ETOR 150 DMSO) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|
1636455|NCT01980940|3007400|Superiority or Other||Treatment ratio|8.12|||||2-Sided|90.0|6.39|10.32||||||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the formulation comparison (ETOR 150 DMSO/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|
1636456|NCT01980940|3007400|Superiority or Other||Treatment ratio|9.32|||||2-Sided|90.0|4.77|18.18||||||The GLSMR and 90% confidence interval was calculated for AUC0-last after log transformation for the formulation comparison (ETOR 75 DMSO/ETOR 75 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. AUC with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|
1636457|NCT01980940|3007402|Superiority or Other||Treatment ratio|0.65|||||2-Sided|90.0|0.51|0.83||||||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the dose comparison (ETOR 75 PG/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|
1636458|NCT01980940|3007402|Superiority or Other||Treatment ratio|0.45|||||2-Sided|90.0|0.38|0.55||||||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the dose comparison (ETOR 75 DMSO/ETOR 150 DMSO) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|
1636459|NCT01980940|3007402|Superiority or Other||Treatment ratio|7.3|||||2-Sided|90.0|6.05|8.81||||||The GLSMR and 90% confidence interval was calculated for Cmax after log transformation for the formulation comparison (ETOR 150 DMSO/ETOR 150 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|
1636460|NCT01980940|3007402|Superiority or Other||Treatment ratio|5.09|||||2-Sided|90.0|4.03|6.42||||||The geometric least squares mean ratio (GLSMR) and 90% confidence interval was calculated for Cmax after log transformation for the formulation comparison (ETOR 75 DMSO/ETOR 75 PG) using a linear mixed effect model with fixed effects terms for treatment and period and random effect for participants. Cmax with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|
1636461|NCT01980771|3007417|Superiority||Odds Ratio (OR)|1.58||||0.04|2-Sided|95.0|1.03|2.43|||Mixed Models Analysis||||
1636462|NCT01980706|3007418|Superiority||Table probability for Fisher's Exact|0.002||||0.07|2-Sided|||||Threshold for significance is <.05|Fisher Exact||||
1636463|NCT01980706|3007419|Superiority||Mean Difference (Final Values)|0.52||||0.6|2-Sided|||||Threshold for significance is <.05|ANCOVA|Adjusted for baseline|Estimated parameter is the overall treatment main effect F statistic from the fitted ANCOVA model assessing the null hypothesis of equal values across the three groups||
1636464|NCT01980706|3007420|Superiority||Mean Difference (Net)|0.84||||0.43|2-Sided|||||Threshold for significance is <.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.||
1636465|NCT01980706|3007421|Superiority||Mean Difference (Net)|0.65||||0.52|2-Sided|||||Threshold for significance is <.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.||
1636466|NCT01980706|3007422|Superiority||Mean Difference (Net)|3.68||||0.028|2-Sided|||||Threshold for significance is <.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.||
1636467|NCT01980706|3007423|Superiority||Mean Difference (Net)|4.16||||0.018|2-Sided|||||Threshold for significance is <.05|Mixed Models Analysis||Overall, treatment effect F value testing under the null hypothesis the equality of the average outcome over the three groups.||
1636468|NCT01980485|3007439|Non-Inferiority or Equivalence|This study had 87% power to detect a 40% increase in 28-dayabstinence rates (i.e., from 50% to 70%) based on a two-tailed chi-squared test and alpha = 0.05. We selected this effect size as being at the lower end of the effect size continuum that would be clinically meaningful at 28 days and have the potential to still be meaningful in the longer term even with similar relapse rates in both groups over subsequent months.||||||0.65|||||||Chi-squared||||
1636469|NCT01980095|3007446|Superiority or Other (legacy)|||||||0.001|||||||One-sample Z-test, RHB-105 subjects only||||
1636574|NCT01977222|3007724|Other|||||||0.3385|||||||t-test, 2 sided||||
1636575|NCT01977222|3007725|Other|||||||0.5374|||||||t-test, 2 sided||||
1636472|NCT01979952|3007456|Superiority or Other||Adjusted mean difference|-0.05|Standard Error of the Mean|2.434|||2-Sided|95.0|-4.89|4.79||||||MMRM model included treatment, visit, baseline value, treatment-by-visit and baseline-by-visit as fixed effects and patient as random effect. Unstructured covariance was assumed for within patient variation|
1636473|NCT01979952|3007458|Superiority or Other||Adjusted mean difference|2.36|||||2-Sided|95.0|-0.29|5.0||||||MMRM model with fixed effects for treatment, visit, gender, age, height, treatment−by−visit, baseline FVC, baseline FVC−by−visit and random effect for patient. Within−patient errors are modelled by unstructured covariance matrix.|
1636474|NCT01979952|3007459|Superiority or Other||Adjusted mean difference|69.0|Standard Error of the Mean|39.182|||2-Sided|95.0|-8.74|146.75||||||Mixed Model for Repeated Measures (MMRM) model with fixed effects for treatment, visit, gender, age, height, treatment−by−visit, baseline FVC, baseline FVC−by−visit and random effect for patient. Within−patient errors are modelled by unstructured covariance matrix.|
1636475|NCT01979952|3007460|Superiority or Other||Adjusted mean difference|2.519|Standard Error of the Mean|6.3829|||2-Sided|95.0|-10.258|15.296||||||Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate|
1636476|NCT01979952|3007461|Superiority or Other||Adjusted mean difference|3.176|Standard Error of the Mean|6.237|||2-Sided|95.0|-9.227|15.579||||||Analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline HRCT QLF score as covariate|
1636477|NCT01979614|3007472|Superiority or Other||Standard Error|-0.1116||||0.438|2-Sided|95.0|-0.399|0.176|||ANCOVA|||SAP for Global Myocardial Perfusion Reserve Index (MPRI)|
1636478|NCT01979523|3007480|Other|||||||0.74|||||||Log Rank||||
1636479|NCT01979185|3007489|Non-Inferiority or Equivalence|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.594|||||2-Sided|90.0|0.526|0.672||||||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.|
1636480|NCT01979185|3007490|Non-Inferiority or Equivalence|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.63|||||2-Sided|90.0|0.543|0.73||||||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.|
1636481|NCT01979185|3007491|Non-Inferiority or Equivalence|If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.|Ratio of Geometric LS Means|0.632|||||2-Sided|90.0|0.538|0.744||||||The means of the log-transformed pharmacokinetic parameters were compared between treatments using a mixed-effects model with period and treatment as fixed effects, and subject nested within sequence as a random effect. In order to estimate the magnitude of the treatment regimen differences in pharmacokinetic parameters, the geometric mean ratio (i.e., the least squares mean difference in the log-transformed parameters back transformed to the original scale) and their 90% CIs were calculated.|
1636482|NCT01979133|3007495|Superiority or Other|||||||0.066|||||||Wilcoxon (Mann-Whitney)||||
1636483|NCT01979133|3007496|Superiority or Other|||||||0.231|||||||Wilcoxon (Mann-Whitney)||||
1636484|NCT01979133|3007497|Superiority or Other|||||||0.034|||||||Wilcoxon (Mann-Whitney)||||
1636485|NCT01979133|3007498|Superiority or Other|||||||0.038|||||||Wilcoxon (Mann-Whitney)||||
1636486|NCT01979133|3007499|Superiority or Other|||||||0.017|||||||Wilcoxon (Mann-Whitney)||||
1636487|NCT01979133|3007500|Superiority or Other|||||||0.005|||||||Wilcoxon (Mann-Whitney)||||
1636488|NCT01979133|3007501|Superiority or Other|||||||0.012|||||||Wilcoxon (Mann-Whitney)||||
1636489|NCT01979016|3007505|Superiority||LS Mean Difference|-3.7|||<|0.0001|2-Sided|95.0|-5.02|-2.39|||ANCOVA||||
1636490|NCT01979016|3007507|Superiority||LS Mean Difference|-46.2|||<|0.0001|2-Sided|95.0|-63.9|-28.5|||ANCOVA|||Analysis was performed by a MMRM model.|
1636491|NCT01979016|3007508|Superiority||LS Mean Difference|-10.4|||<|0.0001|2-Sided|95.0|-14.3|-6.6|||ANCOVA|||Analysis was performed by a MMRM model.|
1636492|NCT01979016|3007509|Superiority||Percentage difference|7.4|||=|0|2-Sided|95.0|-2.5|17.3|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 90% reduction from baseline in SCORAD Score (SCORAD-90). Analysis was performed by a MMRM model.|
1636493|NCT01979016|3007509|Superiority||Percentage difference|11.1|||=|0|2-Sided|95.0|-0.7|23.0|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 75% reduction from baseline in SCORAD Score (SCORAD-75). Analysis was performed by a MMRM model.|
1636494|NCT01979016|3007509|Superiority||Percentage difference|48.1|||=|0|2-Sided|95.0|27.0|69.3|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 50% reduction from baseline in SCORAD Score (SCORAD-50). Analysis was performed by a MMRM model.|
1636495|NCT01979016|3007510|Superiority||Percentage difference|33.3|||=|0|2-Sided|95.0|15.55|51.11|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 90% reduction from baseline in EASI score (EASI-90). Analysis was performed by a MMRM model.|
1636496|NCT01979016|3007510|Superiority||Percentage difference|51.9|||=|0|2-Sided|95.0|29.59|74.12|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 75% reduction from baseline in EASI score (EASI-75). Analysis was performed by a MMRM model.|
1636576|NCT01977222|3007726|Other|||||||0.776|||||||t-test, 2 sided||||
1636497|NCT01979016|3007510|Superiority||Percentage difference|55.6|||<|0.0001|2-Sided|95.0|33.38|77.73|||Cochran-Mantel-Haenszel|||Statistical comparison for percentage of participants who achieved 50% reduction from baseline in EASI score (EASI-50). Analysis was performed by a MMRM model.|
1636498|NCT01979016|3007511|Superiority||LS Mean Difference|-46.6|||<|0.0001|2-Sided|95.0|-62.0|-31.3|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by MMRM model.|
1636499|NCT01979016|3007512|Superiority||LS Mean Difference|-31.3|||<|0.0001|2-Sided|95.0|-41.5|-21.1|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.|
1636500|NCT01979016|3007513|Superiority||LS Mean Difference|-21.5|||<|0.0001|2-Sided|95.0|-29.0|-14.0|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.|
1636501|NCT01979016|3007514|Superiority||LS Mean Difference|-48.08|||=|0|2-Sided|95.0|-71.31|-24.85|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.|
1636502|NCT01979016|3007515|Superiority||LS Mean Difference|-2.66|||<|0.0001|2-Sided|95.0|-3.8|-1.52|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.|
1636503|NCT01979016|3007516|Superiority||Percentage difference|48.1|||<|0.0001|2-Sided|95.0|28.0|68.3|||Cochran-Mantel-Haenszel||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.|
1636504|NCT01979016|3007517|Superiority||Percentage difference|37.0|||=|0|2-Sided|95.0|18.82|55.25|||Cochran-Mantel-Haenszel||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a MMRM model.|
1636505|NCT01979016|3007518|Superiority||Least Squares (LS) Mean Difference|-69.4|||<|0.0001|2-Sided|95.0|-92.5|-46.2|||ANCOVA||Dupilumab 200 mg qw vs Placebo qw|Analysis was performed by a mixed model repeated measures (MMRM) model.|
1636506|NCT01978938|3007521|Non-Inferiority|The NI test was based on the lower limit of the 2-sided 95% confidence interval (CI), using the method proposed without stratification by Miettinen and Nurminen. If the lower limit of the 95% CI for the difference in Responder (clinical cure and microbiologic success) rates in the micro-ITT population exceeded −10%, then the null hypothesis was rejected and the NI of eravacycline to levofloxacin was declared.|Treatment Difference|-6.5|||||2-Sided|95.0|-14.1|1.2||||||For the FDA, an NI margin of 10% was used, which was based on historical data regarding the treatment effect of antibiotics. A 10% NI margin for the Responder outcome is robust and can sufficiently confirm a clinically meaningful treatment effect of eravacycline in the treatment of cUTI.|
1636507|NCT01978145|3007590|Superiority or Other||Mean Difference (Net)|-0.6|||||2-Sided|95.0|-1.1|-0.02|||||||
1636508|NCT01978145|3007591|Superiority or Other||Mean Difference (Net)|0.24|||||2-Sided|95.0|-0.7|1.19|||||||
1636509|NCT01978145|3007592|Superiority or Other||Mean Difference (Net)|-0.133|||||2-Sided|95.0|-0.413|0.148|||||The estimated and 95% CI values are presented for Day 85.||
1636510|NCT01978145|3007592|Superiority or Other||Mean Difference (Net)|-0.069||||||95.0|-0.349|0.212|||||The estimated and 95% CI values are presented for Day 56.||
1636511|NCT01978145|3007592|Superiority or Other||Mean Difference (Net)|-0.003|||||2-Sided|95.0|-0.278|0.272|||||The estimated and 95% CI values are presented for Day 28.||
1636512|NCT01978145|3007593|Superiority or Other||Mean Difference (Final Values)|0.166||||||95.0|-0.06|0.393|||||||
1636513|NCT01978145|3007594|Superiority or Other||Mean Difference (Net)|0.02|||||2-Sided|95.0|-0.005|0.044|||||The estimated value and 95% CI values are provided for Day 56||
1636514|NCT01978145|3007594|Superiority or Other||Mean Difference (Net)|0.004|||||2-Sided|95.0|-0.019|0.027|||||The estimated value and 95% CI values are provided for Day 28||
1636515|NCT01978145|3007595|Non-Inferiority or Equivalence|Non- inferiority was demonstrated if lower limit of the CI (0.025 one sided significance level) for the difference of the mean change from Baseline in trough FEV1 of FSC administered BID by CB DPI versus FSC administered BID by MD DPI is greater than -45 milliliter (mL).|Mean Difference (Net)|0.025|||||2-Sided|95.0|0.002|0.047|||||||
1636516|NCT01978119|3007596|Superiority or Other||Mean Difference (Net)|-0.77|||||2-Sided|95.0|-4.64|3.11|||||||
1636517|NCT01978119|3007597|Superiority or Other||Mean Difference (Net)|-0.2|||||2-Sided|95.0|-0.9|0.5|||||||
1636518|NCT01978119|3007598|Superiority or Other||Mean Difference (Net)|-2.25|||||2-Sided|95.0|-6.97|2.46|||||||
1636519|NCT01978119|3007600|Superiority or Other||Mean Difference (Net)|-0.06|||||2-Sided|95.0|-0.2|0.09|||||||
1636520|NCT01978119|3007601|Superiority or Other||Mean Difference (Net)|4.35|||||2-Sided|95.0|-1.34|10.05|||||||
1636521|NCT01978119|3007602|Superiority or Other||Mean Difference (Net)|0.022||||||95.0|-0.049|0.092|||||Day 56 Change from Baseline Analysis||
1636522|NCT01978119|3007602|Superiority or Other||Mean Difference (Net)|0.007|||||2-Sided|95.0|-0.074|0.088|||||Day 28 Change from Baseline Analysis||
1636523|NCT01978119|3007603|Superiority or Other||Mean Difference (Final Values)|0.278|||||2-Sided|95.0|-0.372|0.927|||||||
1636524|NCT01978119|3007604|Superiority or Other||Mean Difference (Final Values)|-0.352|||||2-Sided|95.0|-1.039|0.334|||||||
1636525|NCT01978119|3007605|Non-Inferiority or Equivalence|Non- inferiority was demonstrated if lower limit of the CI (0.025 one sided significance level) for the difference of the mean change from Baseline in trough FEV1 of FSC administered BID by capsule-based unit dose DPI versus FSC administered BID by multi-dose DPI is greater than -125 milliliter (mL).|Mean Difference (Net)|0.028|||||2-Sided|95.0|-0.024|0.08|||||||
1636526|NCT01978093|3007620|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.22|||||2-Sided|97.5|1.0|1.5|||||To be able to conclude independently on primary objectives of Epoch 001 & Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the fourth dose|
1636527|NCT01978093|3007620|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB Group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.12|||||2-Sided|97.5|0.95|1.34|||||To be able to conclude independently on primary objectives of Epoch 001 & Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the fourth dose|
1636577|NCT01977222|3007727|Other|||||||0.511|||||||t-test, 2 sided||||
1636528|NCT01978093|3007620|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.09|||||2-Sided|97.5|0.9|1.31|||||To be able to conclude independently on primary objectives of Epoch 001 & Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the fourth dose|
1636529|NCT01978093|3007620|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.14|||||2-Sided|97.5|0.97|1.35|||||To be able to conclude independently on primary objectives of Epoch 001 & Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the fourth dose|
1636530|NCT01978093|3007620|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||2-Sided|97.5|0.96|1.41|||||To be able to conclude independently on primary objectives of Epoch 001 & Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the fourth dose|
1636531|NCT01978093|3007620|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.12|||||2-Sided|97.5|0.94|1.33|||||To be able to conclude independently on primary objectives of Epoch 001 & Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the fourth dose|
1636532|NCT01978093|3007620|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.09|||||2-Sided|97.5|0.93|1.29|||||To be able to conclude independently on primary objectives of Epoch 001 & Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the fourth dose|
1636533|NCT01978093|3007620|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.13|||||2-Sided|97.5|0.94|1.36|||||To be able to conclude independently on primary objectives of Epoch 001 & Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the fourth dose|
1636534|NCT01978093|3007620|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.21|||||2-Sided|97.5|1.01|1.44|||||To be able to conclude independently on primary objectives of Epoch 001 & Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the fourth dose|
1636535|NCT01978093|3007620|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.06|||||2-Sided|97.5|0.87|1.28|||||To be able to conclude independently on primary objectives of Epoch 001 & Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the fourth dose|
1636536|NCT01978093|3007620|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.1|||||2-Sided|97.5|0.92|1.31|||||To be able to conclude independently on primary objectives of Epoch 001 & Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the fourth dose|
1636537|NCT01978093|3007620|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.01|||||2-Sided|97.5|0.83|1.24|||||To be able to conclude independently on primary objectives of Epoch 001 & Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the fourth dose|
1636538|NCT01978093|3007620|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.25|||||2-Sided|97.5|1.04|1.51|||||To be able to conclude independently on primary objectives of Epoch 001 & Epoch 002, a Bonferroni correction is used to test these primary objectives(1.25% one-sided for Epoch 001 and Epoch 002)|GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the fourth dose|
1636539|NCT01978093|3007621|Non-Inferiority|Lower limit of the two-sided standardized asymptotic 97.5% CI on the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-HAV concentrations ≥15 mIU/mL is to be≥-10% (clinical limit for non-inferiority).|Difference in percentage of subjects|0.0|||||2-Sided|97.5|-3.76|3.91|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix & Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|Difference between HibCY and PedHIB groups in percentage of subjects with anti-HAV concentrations equal to or above the cut-off value of 15 mIU/mL one month after the second Havrix dose.|
1636540|NCT01978093|3007622|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 23F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||2-Sided|97.5|0.91|1.53|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the third dose.|
1636541|NCT01978093|3007622|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.07|||||2-Sided|97.5|0.89|1.29|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the third dose.|
1636542|NCT01978093|3007622|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 19A is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||2-Sided|97.5|0.94|1.43|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the third dose.|
1636543|NCT01978093|3007622|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 18C is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.24|||||2-Sided|97.5|1.01|1.52|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the third dose.|
1636544|NCT01978093|3007622|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 14 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.16|||||2-Sided|97.5|0.9|1.5|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the third dose.|
1636545|NCT01978093|3007622|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 9V is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.25|||||2-Sided|97.5|1.0|1.55|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the third dose.|
1636546|NCT01978093|3007622|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 7F is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.11|||||2-Sided|97.5|0.91|1.34|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the third dose.|
1636547|NCT01978093|3007622|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6B is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.17|||||2-Sided|97.5|0.88|1.55|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the third dose.|
1636548|NCT01978093|3007622|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 6A is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.29|||||2-Sided|97.5|1.03|1.63|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the third dose.|
1636549|NCT01978093|3007622|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 5 is to be ≥ 0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||2-Sided|97.5|0.95|1.47|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the third dose.|
1636550|NCT01978093|3007622|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 4 is to be≥ 0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.08|||||2-Sided|97.5|0.9|1.31|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the third dose.|
1636578|NCT01977222|3007728|Other|||||||0.5745|||||||t-test, 2 sided||||
1636579|NCT01977222|3007729|Other|||||||0.1673|||||||t-test, 2 sided||||
1636551|NCT01978093|3007622|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 3 is to be≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.15|||||2-Sided|97.5|0.93|1.42|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix&Prevnar13 post dose 4),a Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the third dose.|
1636552|NCT01978093|3007622|Non-Inferiority|Lower limit of the two-sided 97.5% CI on the GMC ratio (HibCY group over PedHIB group) for antibodies to S. pneumoniae serotype 1 is to be ≥0.5 (clinical limit for non-inferiority).|Adjusted GMC ratio|1.18|||||2-Sided|97.5|0.95|1.47|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 post dose 3)& Epoch 002(Havrix & Prevnar13 post dose 4),Bonferroni correction is used to test these primary objectives(1.25% 1sided for Epoch 001 & Epoch 002)|GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the third dose.|
1636553|NCT01978093|3007623|Non-Inferiority|Non-inferiority is concluded if lower limit of the two-sided standardized asymptotic 97.5% CI on the ratio of anti-rotavirus IgA GMC (HibCY group over PedHIB group) is to be ≥0.5|Adjusted GMC ratios|1.21|||||2-Sided|97.5|0.77|1.9|||||To be able to conclude independently on primary objectives of Epoch 001(Rotarix & Prevnar13 Post dose 3)& Epoch 002 (Havrix & Prevnar13 post dose 4),a Bonferroni correction is used in order to test these objectives(1.25% 1sided for Epoch 001 & 002)|GMC ratios between HibCY and PedHIB groups for anti-Rota IgA concentrations 2 months after the second dose of Rotarix vaccine|
1636554|NCT01978093|3007624|Non-Inferiority|Lower limit of the standardized asymptotic 95% CI for the difference (HibCY group minus the PedHIB group) in the percentage of subjects with anti-PRP concentrations ≥1.0 mg/mL is to be≥-10% (clinical limit for non-inferiority).|Difference in percentage of subjects|0.96|||||2-Sided|95.0|-2.12|4.3||||||Difference between HibCY and PedHIB groups in percentage of subjects with anti-PRP concentrations equal to or above the cut-off value of 1.0 µg/mL one month after the fourth dose in HibCY Group and third dose in PedHIB Group.|
1636555|NCT01977937|3007625|Other|||||||0.02|||||||t-test, 2 sided|||Differences in the average total daily opioid were compared between groups using an unpaired two-tailed Student’s t-test|
1636556|NCT01977937|3007626|Other|Differences in average pre-operative & total post-operative average VAS scores were compared between groups using an unpaired Mann-Whitney rank sum test. Hospitalization outcomes including number of days to transition off PCA, number of days with Foley catheter, & episodes of nausea, emesis, or POSS > 3 were compared between groups using an unpaired two-tailed Student’s t-test. Statistical significance was defined as p<0.05 for all unpaired parametric and non-parametric comparisons.||||||0.07|||||||t-test, 2 sided|||D'Agostino & Pearson normality test was used to assess for normal distribution. Experimental & control groups were assessed for significant differences in age, hospital days, & spinal levels fused using unpaired two-tailed Student’s t-test. Differences in weight & BMI were assessed using unpaired Mann-Whitney rank sum test. Differences in average VAS scores on the operative day, each post-operative day, and average total daily opioid were compared using an unpaired two-tailed Student’s t-test.|
1636557|NCT01977794|3007640|Superiority or Other||||||<|0.001||||||P value in both groups (Amlodipine failed and Bisoprolol failed) for comparison of SBP after 18 weeks versus baseline|Paired t test|||For each group (Amlodipine failed and Bisoprolol failed) SBP after 18 weeks compared to baseline (under monotherapy). Superiority was assessed between FDC and monotherapies.|
1636558|NCT01977781|3007647|Superiority or Other|||||||0.0019|||||||Wilcoxon (Mann-Whitney)|||Only the statistical analysis results for burning sensation at 10 weeks are reported below as they where the only tolerability results found to be significantly different between the two arms. All other tolerability measures were found to be the same between the two groups.|
1636559|NCT01977482|3007710|Superiority or Other||Dose that achieves a change of 1 g/dL|13.248|||||2-Sided|95.0|10.891|18.916|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1636560|NCT01977482|3007710|Superiority or Other||Dose that achieves a change of 0.75 g/dL|10.8|||||2-Sided|95.0|9.024|14.004|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1636561|NCT01977482|3007710|Superiority or Other||Dose that achieves a change of 0.5 g/dL|8.542|||||2-Sided|95.0|6.931|10.523|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1636562|NCT01977482|3007710|Superiority or Other||Dose that achieves a change of 0.25 g/dL|6.43|||||2-Sided|95.0|4.698|8.01|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1636563|NCT01977482|3007710|Superiority or Other||Target Dose (TD) (mg)|4.406|||||2-Sided|95.0|2.544|5.995|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1636564|NCT01977482|3007710|Superiority or Other||Dose that achieves a change of -0.25g/dL|2.423|||||2-Sided|95.0|0.0|4.15|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1636565|NCT01977482|3007710|Superiority or Other||Minimally Effective Dose (MED) (mg)|0.418|||||2-Sided|95.0|0.0|2.342|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1636566|NCT01977482|3007710|Superiority or Other||Alpha|-0.206|||||2-Sided|95.0|-0.397|-0.014|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1636567|NCT01977482|3007710|Superiority or Other||Var|1.012|||||2-Sided|95.0|0.84|1.234|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1636568|NCT01977482|3007710|Superiority or Other||Gamma|1.145|||||2-Sided|95.0|0.748|1.738|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1636569|NCT01977482|3007710|Superiority or Other||Emax (g/dL)|5.234||||||95.0|2.691|7.94|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1636570|NCT01977482|3007710|Superiority or Other||ED50 (milligrams[mg])|33.531|||||2-Sided|95.0|15.566|48.948|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1636571|NCT01977482|3007710|Superiority or Other||E0 (g/dL)|-0.664|||||2-Sided|95.0|-0.96|-0.387|||||Posterior median and 95% credibility intervals were estimated using Bayesian methods.||
1636572|NCT01977222|3007722|Other|||||||0.1183|||||||t-test, 2 sided||||
1636573|NCT01977222|3007723|Other|||||||0.0189|||||||t-test, 2 sided||||
1636586|NCT01976806|3007769|Superiority or Other||Mean Difference (Net)|-0.29|Standard Error of the Mean|0.13|<|0.05|||||||Mixed Models Analysis|Compound-symmetry covariance structure with age, sex, BMI, race, baseline pocket depth, baseline RBC DHA level, and intervention group variables|Mean change in pocket depth (3-month follow-up minus baseline) among dental sites with baseline pocket depths >=5 mm in the DHA intervention group versus the placebo group.|Intent-to-treat basis with a type I error rate of 0.05. The follow-up pocket depth, was assessed in linear mixed effects models with a compound-symmetry covariance structure and age, sex, BMI, race, baseline pocket depth, baseline red blood cell (RBC) DHA level (dichotomized at median), and intervention group as fixed-effect variables.|
1636587|NCT01976741|3007788|Other|dose proportionality|LS Mean|9.51||||0.9018|2-Sided|90.0|7.3|12.39|||ANOVA||||
1636588|NCT01976741|3007788|Other|dose proportionality||||||0.2631|||||||ANOVA||||
1636589|NCT01976741|3007792|Other|dose proportionality|LS Mean|72.7||||0.8224|2-Sided|90.0|58.68|90.08|||ANOVA||||
1636590|NCT01976741|3007792|Other|dose proportionality||||||0.0005|||||||ANOVA||||
1636591|NCT01976741|3007794|Other|dose proportionality|LS Mean|6.03||||0.4888|2-Sided|90.0|4.52|8.05|||ANOVA||||
1636592|NCT01976741|3007794|Other|dose proportionality||||||0.3264|||||||ANOVA||||
1636593|NCT01976741|3007796|Other|dose proportionality|LS Mean|6.59||||0.5377|2-Sided|90.0|5.04|8.61|||ANOVA||||
1636594|NCT01976741|3007796|Other|dose proportionality||||||0.1828|||||||ANOVA||||
1636595|NCT01976741|3007800|Other|dose proportionality|LS Mean|73.04||||0.9361|2-Sided|90.0|60.5|88.18|||ANOVA||||
1636596|NCT01976741|3007800|Other|dose proportionality|||||<|0.0001|||||||ANOVA||||
1636597|NCT01976364|3007833|Other||LS mean difference|-4.9|||||2-Sided|95.0|-9.9|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636598|NCT01976364|3007833|Other||LS mean difference|-2.8|||||2-Sided|95.0|-7.3|1.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636599|NCT01976364|3007833|Other||LS mean difference|-6.3|||||2-Sided|95.0|-10.2|-2.4||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636600|NCT01976364|3007833|Other||LS mean difference|-1.5|||||2-Sided|95.0|-5.8|2.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636601|NCT01976364|3007833|Other||LS mean difference|-2.9|||||2-Sided|95.0|-6.2|0.4||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636602|NCT01976364|3007834|Other||LS mean difference|-0.1|||||2-Sided|95.0|-0.2|0.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636603|NCT01976364|3007834|Other||LS mean difference|-0.1|||||2-Sided|95.0|-0.3|0.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636604|NCT01976364|3007834|Other||LS mean difference|-0.1|||||2-Sided|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636605|NCT01976364|3007834|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636606|NCT01976364|3007834|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.2|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636607|NCT01976364|3007835|Other||LS mean difference|0.1|||||2-Sided|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636608|NCT01976364|3007835|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636609|NCT01976364|3007835|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636610|NCT01976364|3007835|Other||LS mean difference|0.1|||||2-Sided|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636611|NCT01976364|3007835|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636612|NCT01976364|3007836|Other||LS mean difference|0.1|||||2-Sided|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636613|NCT01976364|3007836|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636614|NCT01976364|3007836|Other||LS mean difference|0.1|||||2-Sided|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636615|NCT01976364|3007836|Other||LS mean difference|0.1|||||2-Sided|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636616|NCT01976364|3007836|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636617|NCT01976364|3007837|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636618|NCT01976364|3007837|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.1|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636619|NCT01976364|3007837|Other||LS mean difference|0.1|||||2-Sided|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636620|NCT01976364|3007837|Other||LS mean difference|0.1|||||2-Sided|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636621|NCT01976364|3007837|Other||LS mean difference|0.0|||||2-Sided|95.0|0.0|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636622|NCT01976364|3007838|Other||LS mean difference|0.1|||||2-Sided|95.0|0.0|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636623|NCT01976364|3007838|Other||LS mean difference|0.1|||||2-Sided|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636624|NCT01976364|3007838|Other||LS mean difference|0.1|||||2-Sided|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636625|NCT01976364|3007838|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636626|NCT01976364|3007838|Other||LS mean difference|0.1|||||2-Sided|95.0|-0.1|0.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636627|NCT01976364|3007839|Other||LS mean difference|0.8|||||2-Sided|95.0|-0.3|1.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636628|NCT01976364|3007839|Other||LS mean difference|1.2|||||2-Sided|95.0|0.0|2.3||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636629|NCT01976364|3007839|Other||LS mean difference|0.1|||||2-Sided|95.0|-1.0|1.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636630|NCT01976364|3007839|Other||LS mean difference|0.7|||||2-Sided|95.0|-0.3|1.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636631|NCT01976364|3007839|Other||LS mean difference|0.5|||||2-Sided|95.0|-0.6|1.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1637108|NCT01972152|3008494|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Data were log transformed for analysis|||
1636632|NCT01976364|3007840|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.9|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636633|NCT01976364|3007840|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.9|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636634|NCT01976364|3007840|Other||LS mean difference|-0.7|||||2-Sided|95.0|-1.6|0.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636635|NCT01976364|3007840|Other||LS mean difference|-0.1|||||2-Sided|95.0|-1.0|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636636|NCT01976364|3007840|Other||LS mean difference|0.4|||||2-Sided|95.0|-0.4|1.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636637|NCT01976364|3007841|Other||LS mean difference|0.8|||||2-Sided|95.0|-1.1|2.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636638|NCT01976364|3007841|Other||LS mean difference|1.1|||||2-Sided|95.0|-0.8|2.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636639|NCT01976364|3007841|Other||LS mean difference|-0.7|||||2-Sided|95.0|-2.4|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636640|NCT01976364|3007841|Other||LS mean difference|0.5|||||2-Sided|95.0|-1.1|2.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636641|NCT01976364|3007841|Other||LS mean difference|0.8|||||2-Sided|95.0|-0.9|2.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636642|NCT01976364|3007842|Other||LS mean difference|0.38|||||2-Sided|95.0|-1.62|2.38||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636643|NCT01976364|3007842|Other||LS mean difference|1.07|||||2-Sided|95.0|-0.93|3.07||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636644|NCT01976364|3007842|Other||LS mean difference|-0.25|||||2-Sided|95.0|-2.4|1.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636645|NCT01976364|3007842|Other||LS mean difference|0.11|||||2-Sided|95.0|-1.72|1.95||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636646|NCT01976364|3007842|Other||LS mean difference|0.93|||||2-Sided|95.0|-0.95|2.81||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636647|NCT01976364|3007843|Other||LS mean difference|-0.79|||||2-Sided|95.0|-3.1|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636648|NCT01976364|3007843|Other||LS mean difference|0.73|||||2-Sided|95.0|-1.49|2.95||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636649|NCT01976364|3007843|Other||LS mean difference|-0.09|||||2-Sided|95.0|-2.27|2.09||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636650|NCT01976364|3007843|Other||LS mean difference|-0.61|||||2-Sided|95.0|-2.86|1.63||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636651|NCT01976364|3007843|Other||LS mean difference|-1.67|||||2-Sided|95.0|-3.67|0.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636652|NCT01976364|3007844|Other||LS mean difference|0.53|||||2-Sided|95.0|-1.58|2.63||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636653|NCT01976364|3007844|Other||LS mean difference|0.28|||||2-Sided|95.0|-1.81|2.36||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636654|NCT01976364|3007844|Other||LS mean difference|-0.57|||||2-Sided|95.0|-2.72|1.57||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636655|NCT01976364|3007844|Other||LS mean difference|-0.38|||||2-Sided|95.0|-2.46|1.71||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636656|NCT01976364|3007844|Other||LS mean difference|0.78|||||2-Sided|95.0|-1.27|2.82||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636657|NCT01976364|3007845|Other||LS mean difference|0.95|||||2-Sided|95.0|-0.82|2.73||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636658|NCT01976364|3007845|Other||LS mean difference|-0.47|||||2-Sided|95.0|-2.25|1.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636659|NCT01976364|3007845|Other||LS mean difference|-1.71|||||2-Sided|95.0|-3.66|0.23||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636660|NCT01976364|3007845|Other||LS mean difference|-0.86|||||2-Sided|95.0|-2.51|0.79||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636661|NCT01976364|3007845|Other||LS mean difference|-0.36|||||2-Sided|95.0|-2.06|1.35||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636662|NCT01976364|3007846|Other||LS mean difference|0.04|||||2-Sided|95.0|-1.46|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636663|NCT01976364|3007846|Other||LS mean difference|0.01|||||2-Sided|95.0|-1.54|1.57||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636664|NCT01976364|3007846|Other||LS mean difference|-0.81|||||2-Sided|95.0|-2.17|0.56||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636665|NCT01976364|3007846|Other||LS mean difference|-1.13|||||2-Sided|95.0|-2.57|0.31||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636666|NCT01976364|3007846|Other||LS mean difference|-0.68|||||2-Sided|95.0|-2.05|0.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636667|NCT01976364|3007847|Other||LS mean difference|-0.3|||||2-Sided|95.0|-2.3|1.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636668|NCT01976364|3007847|Other||LS mean difference|-1.76|||||2-Sided|95.0|-3.99|0.48||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636669|NCT01976364|3007847|Other||LS mean difference|-1.81|||||2-Sided|95.0|-3.7|0.09||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636670|NCT01976364|3007847|Other||LS mean difference|0.34|||||2-Sided|95.0|-1.49|2.18||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636671|NCT01976364|3007847|Other||LS mean difference|0.71|||||2-Sided|95.0|-1.01|2.42||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636672|NCT01976364|3007848|Other||LS mean difference|1.73|||||2-Sided|95.0|-0.06|3.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636673|NCT01976364|3007848|Other||LS mean difference|0.2|||||2-Sided|95.0|-1.57|1.96||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636674|NCT01976364|3007848|Other||LS mean difference|0.7|||||2-Sided|95.0|-0.91|2.31||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636675|NCT01976364|3007848|Other||LS mean difference|1.25|||||2-Sided|95.0|-0.49|2.99||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636676|NCT01976364|3007848|Other||LS mean difference|0.48|||||2-Sided|95.0|-1.08|2.05||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636677|NCT01976364|3007849|Other||LS mean difference|-0.01|||||2-Sided|95.0|-1.89|1.86||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636678|NCT01976364|3007849|Other||LS mean difference|0.32|||||2-Sided|95.0|-1.49|2.13||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636679|NCT01976364|3007849|Other||LS mean difference|-0.53|||||2-Sided|95.0|-2.15|1.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636680|NCT01976364|3007849|Other||LS mean difference|0.17|||||2-Sided|95.0|-1.39|1.73||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636681|NCT01976364|3007849|Other||LS mean difference|0.22|||||2-Sided|95.0|-1.09|1.53||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636682|NCT01976364|3007850|Other||LS mean difference|-0.09|||||2-Sided|95.0|-2.01|1.84||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636683|NCT01976364|3007850|Other||LS mean difference|0.76|||||2-Sided|95.0|-1.31|2.83||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636684|NCT01976364|3007850|Other||LS mean difference|-0.66|||||2-Sided|95.0|-2.68|1.36||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636685|NCT01976364|3007850|Other||LS mean difference|-0.86|||||2-Sided|95.0|-2.65|0.92||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636686|NCT01976364|3007850|Other||LS mean difference|-0.47|||||2-Sided|95.0|-2.22|1.29||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636687|NCT01976364|3007851|Other||LS mean difference|0.52|||||2-Sided|95.0|-0.96|2.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636688|NCT01976364|3007851|Other||LS mean difference|-0.77|||||2-Sided|95.0|-2.44|0.91||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636689|NCT01976364|3007851|Other||LS mean difference|-0.77|||||2-Sided|95.0|-2.09|0.55||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636690|NCT01976364|3007851|Other||LS mean difference|0.33|||||2-Sided|95.0|-1.04|1.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636691|NCT01976364|3007851|Other||LS mean difference|0.33|||||2-Sided|95.0|-0.85|1.51||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636692|NCT01976364|3007852|Other||LS mean difference|0.3672|||||2-Sided|95.0|-1.8107|2.545||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636693|NCT01976364|3007852|Other||LS mean difference|0.0626|||||2-Sided|95.0|-1.5767|1.7018||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636694|NCT01976364|3007852|Other||LS mean difference|-0.7991|||||2-Sided|95.0|-3.0053|1.4071||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636695|NCT01976364|3007852|Other||LS mean difference|-0.566|||||2-Sided|95.0|-1.9054|0.7735||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636696|NCT01976364|3007852|Other||LS mean difference|-0.1535|||||2-Sided|95.0|-2.1444|1.8374||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636697|NCT01976364|3007853|Other||LS mean difference|0.66|||||2-Sided|95.0|-4.03|5.35||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636698|NCT01976364|3007853|Other||LS mean difference|2.01|||||2-Sided|95.0|-2.92|6.93||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636699|NCT01976364|3007853|Other||LS mean difference|0.95|||||2-Sided|95.0|-3.78|5.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636700|NCT01976364|3007853|Other||LS mean difference|-1.23|||||2-Sided|95.0|-5.11|2.65||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636701|NCT01976364|3007853|Other||LS mean difference|-1.11|||||2-Sided|95.0|-4.96|2.74||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636702|NCT01976364|3007854|Other||LS mean difference|-0.13|||||2-Sided|95.0|-4.64|4.38||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636703|NCT01976364|3007854|Other||LS mean difference|0.64|||||2-Sided|95.0|-4.03|5.32||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636704|NCT01976364|3007854|Other||LS mean difference|1.29|||||2-Sided|95.0|-3.48|6.06||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636705|NCT01976364|3007854|Other||LS mean difference|-0.43|||||2-Sided|95.0|-4.69|3.84||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636706|NCT01976364|3007854|Other||LS mean difference|-2.03|||||2-Sided|95.0|-5.58|1.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636707|NCT01976364|3007855|Other||LS mean difference|-0.12|||||2-Sided|95.0|-3.25|3.01||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636708|NCT01976364|3007855|Other||LS mean difference|2.18|||||2-Sided|95.0|-1.46|5.81||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636709|NCT01976364|3007855|Other||LS mean difference|0.47|||||2-Sided|95.0|-2.26|3.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636710|NCT01976364|3007855|Other||LS mean difference|0.77|||||2-Sided|95.0|-2.64|4.18||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636711|NCT01976364|3007855|Other||LS mean difference|0.26|||||2-Sided|95.0|-2.51|3.02||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636712|NCT01976364|3007856|Other||LS mean difference|-0.1|||||2-Sided|95.0|-0.5|0.3||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636713|NCT01976364|3007856|Other||LS mean difference|0.2|||||2-Sided|95.0|-0.3|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636714|NCT01976364|3007856|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.4|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636715|NCT01976364|3007856|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.6|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636716|NCT01976364|3007856|Other||LS mean difference|0.1|||||2-Sided|95.0|-0.3|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636717|NCT01976364|3007857|Other||LS mean difference|0.2|||||2-Sided|95.0|-0.7|1.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636718|NCT01976364|3007857|Other||LS mean difference|0.0|||||2-Sided|95.0|-0.9|0.9||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636719|NCT01976364|3007857|Other||LS mean difference|0.0|||||2-Sided|95.0|-1.0|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636720|NCT01976364|3007857|Other||LS mean difference|-0.4|||||2-Sided|95.0|-1.6|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636721|NCT01976364|3007857|Other||LS mean difference|-0.4|||||2-Sided|95.0|-1.5|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636722|NCT01976364|3007858|Other||Difference in percentage of participants|2.87|||||2-Sided|95.0|-11.63|17.37||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636723|NCT01976364|3007858|Other||Difference in percentage of participants|3.97|||||2-Sided|95.0|-10.58|18.52||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636724|NCT01976364|3007858|Other||Difference in percentage of participants|2.82|||||2-Sided|95.0|-11.8|17.45||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636725|NCT01976364|3007858|Other||Difference in percentage of participants|3.88|||||2-Sided|95.0|-10.74|18.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636726|NCT01976364|3007858|Other||Difference in percentage of participants|4.99|||||2-Sided|95.0|-9.61|19.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636727|NCT01976364|3007859|Other||Difference in percentage of participants|17.08|||||2-Sided|95.0|-15.96|50.12||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636728|NCT01976364|3007859|Other||Difference in percentage of participants|24.17|||||2-Sided|95.0|-5.14|53.47||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636729|NCT01976364|3007859|Other||Difference in percentage of participants|29.58|||||2-Sided|95.0|-3.46|62.62||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636730|NCT01976364|3007859|Other||Difference in percentage of participants|30.42|||||2-Sided|95.0|0.64|60.2||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636731|NCT01976364|3007859|Other||Difference in percentage of participants|11.67|||||2-Sided|95.0|-15.65|38.98||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636732|NCT01976364|3007861|Other||LS mean difference|0.2|||||2-Sided|95.0|-0.6|1.0||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636733|NCT01976364|3007861|Other||LS mean difference|0.2|||||2-Sided|95.0|-0.6|1.1||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1638255|NCT01948310|3011459|Superiority|||||||0.005|||||||t-test, 2 sided|||14-0 weeks|
1636734|NCT01976364|3007861|Other||LS mean difference|-0.2|||||2-Sided|95.0|-1.1|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636735|NCT01976364|3007861|Other||LS mean difference|-0.2|||||2-Sided|95.0|-0.9|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636736|NCT01976364|3007861|Other||LS mean difference|-0.2|||||2-Sided|95.0|-0.9|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636737|NCT01976364|3007862|Other||Difference in percentage of participants|6.25|||||2-Sided|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636738|NCT01976364|3007862|Other||Difference in percentage of participants|6.25|||||2-Sided|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636739|NCT01976364|3007862|Other||Difference in percentage of participants|6.25|||||2-Sided|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636740|NCT01976364|3007862|Other||Difference in percentage of participants|6.25|||||2-Sided|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636741|NCT01976364|3007862|Other||Difference in percentage of participants|6.25|||||2-Sided|95.0|-59.58|72.08||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636742|NCT01976364|3007864|Other||LS mean difference|7.02|||||2-Sided|95.0|-49.73|63.77||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636743|NCT01976364|3007864|Other||LS mean difference|-11.64|||||2-Sided|95.0|-60.87|37.58||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636744|NCT01976364|3007864|Other||LS mean difference|-24.33|||||2-Sided|95.0|-83.35|34.69||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636745|NCT01976364|3007864|Other||LS mean difference|-30.11|||||2-Sided|95.0|-83.58|23.37||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636746|NCT01976364|3007864|Other||LS mean difference|-19.43|||||2-Sided|95.0|-58.06|19.21||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: At Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636747|NCT01976364|3007865|Other||LS mean difference|0.3|||||2-Sided|95.0|-0.1|0.7||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636748|NCT01976364|3007865|Other||LS mean difference|0.5|||||2-Sided|95.0|0.1|0.8||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636749|NCT01976364|3007865|Other||LS mean difference|0.3|||||2-Sided|95.0|0.0|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 6: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636750|NCT01976364|3007865|Other||LS mean difference|0.2|||||2-Sided|95.0|-0.1|0.6||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636751|NCT01976364|3007865|Other||LS mean difference|0.2|||||2-Sided|95.0|-0.1|0.5||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636752|NCT01976364|3007866|Other||Difference in percentage of participants|-10.15|||||2-Sided|95.0|-18.16|-2.14||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 12: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636753|NCT01976364|3007866|Other||Difference in percentage of participants|-2.36|||||2-Sided|95.0|-11.59|6.87||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 9: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636754|NCT01976364|3007866|Other||Difference in percentage of participants|-5.69|||||2-Sided|95.0|-14.26|2.87||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 6: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636755|NCT01976364|3007866|Other||Difference in percentage of participants|-4.57|||||2-Sided|95.0|-12.91|3.77||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 3: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636756|NCT01976364|3007866|Other||Difference in percentage of participants|-0.14|||||2-Sided|95.0|-9.76|9.48||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Month 1: Two-sided 95% CI was based on the normal approximation for the difference in binomial proportions.|
1636757|NCT01976364|3007867|Other||LS Mean Difference|-0.061|||||2-Sided|95.0|-0.309|0.188||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636758|NCT01976364|3007867|Other||LS Mean Difference|0.213|||||2-Sided|95.0|-0.045|0.47||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636759|NCT01976364|3007867|Other||LS Mean Difference|-0.024|||||2-Sided|95.0|-0.266|0.219||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636760|NCT01976364|3007867|Other||LS Mean Difference|0.032|||||2-Sided|95.0|-0.163|0.227||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636761|NCT01976364|3007868|Other||LS Mean Difference|0.0096|||||2-Sided|95.0|-0.0734|0.0927||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 12: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636762|NCT01976364|3007868|Other||LS Mean Difference|-0.0058|||||2-Sided|95.0|-0.0941|0.0825||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 9: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636763|NCT01976364|3007868|Other||LS Mean Difference|0.0325|||||2-Sided|95.0|-0.0372|0.1021||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 3: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636764|NCT01976364|3007868|Other||LS Mean Difference|0.0486|||||2-Sided|95.0|-0.0192|0.1163||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Change at Month 1: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636765|NCT01976364|3007902|Other||LS mean difference|0.091|||||2-Sided|95.0|-0.131|0.313||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Results were based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636766|NCT01976364|3007903|Other||Least Squares (LS) Mean difference|0.0255|||||2-Sided|95.0|-0.0513|0.1022||||||Tofacitinib 5 mg BID + Placebo Vs Tofacitinib 5 mg BID +MTX: Analysis was based on a repeated measures model with the fixed effects of treatment, visit, treatment by visit interaction and baseline value; a common unstructured covariance matrix was used.|
1636767|NCT01976338|3007917|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1636768|NCT01976312|3007924|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1636769|NCT01976104|3007933|Superiority||Difference in change of platelet count|36.3|||<|0.0001|2-Sided|95.0|25.5|45.5|||Wilcoxon Rank Sum Test|P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs. placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.||
1636770|NCT01976104|3007933|Superiority||Difference in change of platelet count|25.4|||<|0.0001|2-Sided|95.0|19.5|32.0|||Wilcoxon Rank Sum Test|P-value was based on Wilcoxon Rank Sum Test for each avatrombopag treatment group versus placebo within each Baseline platelet count cohort.|Difference in change from Baseline of platelet count for avatrombopag versus placebo within each Baseline platelet count cohort was based on Hodges-Lehmann estimation; 95% CI was the asymptotic (Moses) CI||
1636771|NCT01976104|3007934|Superiority||Difference of proportion versus placebo|53.7|||<|0.0001|2-Sided|95.0|35.8|71.6|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups|
1636772|NCT01976104|3007934|Superiority||Difference of proportion versus placebo|60.2|||<|0.0001|2-Sided|95.0|46.8|73.5|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.|
1636773|NCT01976104|3007935|Superiority||Difference of proportion versus placebo|54.6|||<|0.0001|2-Sided|95.0|36.5|72.7|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.|
1636898|NCT01973569|3008206|Superiority|||||||0.0448|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.|||
1636774|NCT01976104|3007935|Superiority||Difference of proportion versus placebo|33.7|||=|0|2-Sided|95.0|15.8|51.6|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the scheduled procedure within each Baseline platelet count cohort.|Difference of proportion vs placebo = proportion of Responders for avatrombopag - proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.|
1636775|NCT01975948|3007937|Other|||||||0.213|||||||Mixed Models Analysis||||
1636776|NCT01975948|3007938|Other|||||||0.009|||||||Mixed Models Analysis||||
1636777|NCT01975948|3007939|Other|||||||0.543|||||||Mixed Models Analysis||||
1636778|NCT01975948|3007940|Other|||||||0.742|||||||Mixed Models Analysis||||
1636779|NCT01975948|3007941|Superiority|||||||0.945||||||We used the Spearman's correlation coefficient using the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.|Generalized estimating equations (GEE)|||Correlation between increases in Physician Comfort and Confidence with program specific tools and Stigma Score.|
1636780|NCT01975948|3007941|Superiority||Cohen'd|3.25|||<|0.001|2-Sided||||||Mixed Models Analysis||||
1636781|NCT01975948|3007942|Superiority|||||||0.476||||||We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.|Generalized estimating equations (GEE)|||Correlation between increases in Physician Comfort and Confidence with non-program specific tools and Stigma Score.|
1636782|NCT01975948|3007942|Other||Cohen'd|1.44|||<|0.001|2-Sided||||||Mixed Models Analysis||||
1636783|NCT01975948|3007943|Other|||||||0.03|||||||Generalized estimating equations (GEE)|We used the slope of a regression line fit using generalized estimating equations (GEE) with an exchangeable correlation structure.||Correlation between increases in Physician Comfort and Confidence in managing mental illness and Stigma Score.|
1636784|NCT01975948|3007943|Other||Cohen'd|1.48|||<|0.001|2-Sided||||||Mixed Models Analysis||||
1636785|NCT01975948|3007945|Other|||||||0.993|||||||Mixed Models Analysis||||
1636786|NCT01975948|3007946|Other||Cohen'd|0.45||||0.03|2-Sided|||||OMS-HC analysis adjusted for practice size: P value applies to between group physicians reduction in one stigma domaine: preference for social distance|Mixed Models Analysis|||Between Group Changes in subscale of the Opening Minds Scale for Health Care Providers (OMS-HC) measures three different dimensions of stigma: attitudes towards people with a mental illness (6 items); health care professionals’ attitudes about disclosure of a mental illness/willingness to seek help for a mental illness (4 items), and preference for social distance (5 items). Items are rated on a 5-point scale. Mean scores can range from one to five with lower scores indicating less stigma.|
1636787|NCT01975948|3007946|Other|||||||0.15|||||||Mixed Models Analysis|||Our calculations indicated that 50 physicians in each of the two groups will provide >80% power to detect clinically significant reductions in stigma as assessed by OMS-HC change scores. Clinically meaningful was defined as a change of 3 points, derived on the basis of this being slightly better than what is usually seen in brief interventions.|
1636788|NCT01975948|3007947|Other|||||||0.047||||||Adjusted for baseline depressive symptoms and unemployment as covariates (p=.016), and non-completers (missing one or more points of follow up data).|Mixed Models Analysis|||One hundred evaluable patients per arm were needed to achieve 80% power to detect a PHQ-9 between-group difference in mean change of 2 points, significance level (α) .05, a two-sided test, and a standard deviation of 5 points. An intra cluster correlation of 0.05 for patient outcomes was used (Murphey et al), and an average cluster size: 3 patients/practice resulted in compensatory increase to 110 patients per arm. Under the assumption that attrition would be 33 % we needed 166 patients per arm.|
1636789|NCT01975935|3007948|Superiority|||||||0.51|||||||t-test, 2 sided||||
1636790|NCT01975935|3007949|Superiority|||||||0.38|||||||t-test, 2 sided||||
1636791|NCT01975935|3007950|Superiority|||||||0.05||||||This is the calculated p value and not the threshold for statistical significance.|t-test, 2 sided||||
1636792|NCT01975909|3007953|Equivalence|We hypothesized that the real TMS would improve the performance of TUG test (i.e., greater percent decrease of time to complete TUG test from baseline) as compared to the sham TMS.||||||0.18|||||||t-test, 2 sided||||
1636793|NCT01975909|3007954|Equivalence|We hypothesized that the real TMS would improve the standing postural control stability (i.e., greater percent decrease increase of postural sway speed from baseline) as compared to the sham TMS.||||||0.009|||||||t-test, 2 sided||||
1636794|NCT01975909|3007955|Equivalence|We hypothesized that the real TMS would improve the performance of 90-second walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.||||||0.69|||||||t-test, 2 sided||||
1636795|NCT01975909|3007956|Equivalence|We hypothesized that the real TMS would improve the performance of 9-hole peg test (i.e., greater percent decrease of time to complete the test from baseline) as compared to the sham TMS.||||||0.12|||||||t-test, 2 sided||||
1636796|NCT01975909|3007957|Equivalence|We hypothesized that the real TMS would improve the performance of 25-foot walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.||||||0.47|||||||t-test, 2 sided||||
1636797|NCT01975909|3007958|Equivalence|We hypothesized that the real TMS would improve the performance of SARA (i.e., greater percent decrease of SARA score from baseline) as compared to the sham TMS.||||||0.29|||||||t-test, 2 sided||||
1636798|NCT01975675|3007966|Superiority or Other||Difference in proportions|0.0|||||2-Sided|95.0|-4.2|4.2|||||The 95% CI on the difference in proportions is based on the exact method (standardized statistic and inverting two 1-sided tests).||
1636799|NCT01975675|3007966|Superiority or Other||Difference in proportions|-3.6|||||2-Sided|95.0|-10.2|1.0|||||The 95% confidence interval (CI) on the difference in proportions is based on the exact method (standardized statistic and inverting two 1-sided tests).||
1636800|NCT01975675|3007967|Superiority or Other||||||<|0.001||||||Treatment-naive noncirrhotic participants in the LDV/SOF+RBV (treatment naive) group were compared to the adjusted historical SVR null rate of 63% using a two-sided exact one-sample binomial test.|Binomial test||||
1637109|NCT01972152|3008494|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Data were log transformed for analysis|||
1636801|NCT01975675|3007967|Superiority or Other||||||<|0.001||||||Treatment-naive noncirrhotic participants in the LDV/SOF (treatment naive) group were compared to the adjusted historical SVR null rate of 63% using a two-sided exact one-sample binomial test.|Binomial test||||
1636802|NCT01975389|3007978|Superiority||LS mean difference|1.06||||0.002|2-Sided|95.0|1.02|1.09|||MMRM|||LS-mean differences, associated 95% CI and p-values were from an MMRM model on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group*visit interaction, log-transformed baseline value, log-transformed baseline value*visit interaction, geographical region and complete statin intolerance.|
1636803|NCT01975389|3007979|Superiority||LS mean difference|0.68|||<|0.001|2-Sided|95.0|0.67|0.69|||MMRM|||Lp(a): LS-mean differences, associated 95% CI and p-values were from an MMRM model on the Difference of log-transformed observations with fixed effects for treatment group, visit, a treatment group*visit interaction, log-transformed baseline value, log-transformed baseline value*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.|
1636804|NCT01975389|3007979|Superiority||LS mean difference|0.82|||<|0.001|2-Sided|95.0|0.81|0.83|||MMRM|||Triglycerides: LS-mean differences, associated 95% CI and p-values were from an MMRM model including observations through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group*visit interaction, log-transformed baseline value, log-transformed baseline value*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.|
1636805|NCT01975389|3007980|Superiority||LS mean difference|-37.99|Standard Error of the Mean|0.39|<|0.001|2-Sided|95.0|-38.75|-37.22|||MMRM|||Total cholesterol: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.|
1636806|NCT01975389|3007980|Superiority||LS mean difference|4.4|Standard Error of the Mean|0.25|<|0.001|2-Sided|95.0|3.9|4.9|||MMRM|||Apo A-I: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.|
1636807|NCT01975389|3007980|Superiority||LS mean difference|6.91|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|6.33|7.5|||MMRM|||HDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.|
1636808|NCT01975389|3007980|Superiority||LS mean difference|-51.4|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|-52.37|-50.42|||MMRM|||Apo B: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.|
1636809|NCT01975389|3007980|Superiority||LS mean difference|-29.2|Standard Error of the Mean|1.14|<|0.001|2-Sided|95.0|-31.44|-26.96|||MMRM|||RLP-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.|
1636810|NCT01975389|3007980|Superiority||LS mean difference|-18.41|Standard Error of the Mean|0.79|<|0.001|2-Sided|95.0|-19.96|-16.86|||MMRM|||VLDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.|
1636811|NCT01975389|3007980|Superiority||LS mean difference|-51.87|Standard Error of the Mean|0.48|<|0.001|2-Sided|95.0|-52.81|-50.94|||MMRM|||Non-HDLC: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.|
1636812|NCT01975389|3007981|Superiority||LS mean difference|-39.31|Standard Error of the Mean|0.64|<|0.001|2-Sided|95.0|-40.55|-38.06|||ANCOVA|||LS-mean difference, associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and complete statin intolerance.|
1636813|NCT01975389|3007982|Superiority||LS mean difference|-73.8|Standard Error of the Mean|0.67|<|0.001|2-Sided|95.0|-75.11|-72.5|||MMRM|||LS mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.|
1636814|NCT01975389|3007983|Superiority||LS mean difference|-56.9|Standard Error of the Mean|0.51|<|0.001|2-Sided|95.0|-57.91|-55.89|||MMRM|||Least square (LS) mean differences, associated 95% CI, and p-values were from an mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.|
1636815|NCT01975389|3007984|Superiority||Hazard Ratio (HR)|0.91||||0.626157|2-Sided|95.0|0.63|1.32|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636816|NCT01975389|3007985|Superiority||Hazard Ratio (HR)|0.95||||0.748975|2-Sided|95.0|0.7|1.3|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636817|NCT01975389|3007986|Superiority||Hazard Ratio (HR)|0.72||||0.002981|2-Sided|95.0|0.58|0.9|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636818|NCT01975389|3007987|Superiority||Hazard Ratio (HR)|1.19||||0.509847|2-Sided|95.0|0.71|2.01|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636819|NCT01975389|3007988|Superiority||Hazard Ratio (HR)|0.77||||0.010457|2-Sided|95.0|0.63|0.94|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636820|NCT01975389|3007989|Superiority||Hazard Ratio (HR)|1.09||||0.678061|2-Sided|95.0|0.72|1.67|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636821|NCT01975389|3007990|Superiority||Hazard Ratio (HR)|0.9||||0.6012|2-Sided|95.0|0.6|1.34|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636822|NCT01975389|3007991|Superiority||Hazard Ratio (HR)|0.67||||0.104998|2-Sided|95.0|0.41|1.09|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636823|NCT01975389|3007993|Superiority||Hazard Ratio (HR)|0.78||||0.294331|2-Sided|95.0|0.5|1.24|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636824|NCT01975389|3007994|Superiority||Hazard Ratio (HR)|0.67||||0.104998|2-Sided|95.0|0.41|1.09|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636825|NCT01975389|3007995|Superiority||Hazard Ratio (HR)|0.77||||0.051534|2-Sided|95.0|0.59|1.0|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636826|NCT01975389|3007996|Superiority||Hazard Ratio (HR)|0.44||||0.162615|2-Sided|95.0|0.14|1.44|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636827|NCT01975389|3007997|Superiority||Hazard Ratio (HR)|0.75||||0.029977|2-Sided|95.0|0.57|0.97|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636828|NCT01975389|3007998|Superiority||Hazard Ratio (HR)|0.82||||0.446033|2-Sided|95.0|0.5|1.36|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636829|NCT01975389|3007999|Superiority||Hazard Ratio (HR)|0.79||||0.018053|2-Sided|95.0|0.65|0.96|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636830|NCT01975389|3008000|Superiority||Hazard Ratio (HR)|0.95||||0.814224|2-Sided|95.0|0.62|1.46|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636831|NCT01975389|3008001|Superiority||Hazard Ratio (HR)|0.78||||0.015694|2-Sided|95.0|0.64|0.95|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636832|NCT01975389|3008002|Superiority||Hazard Ratio (HR)|0.82||||0.035958|2-Sided|95.0|0.68|0.99|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636833|NCT01975389|3008003|Superiority||Hazard Ratio (HR)|0.75||||0.007597|2-Sided|95.0|0.6|0.93|||Log Rank|||Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636834|NCT01975389|3008004|Superiority||Hazard Ratio (HR)|0.79||||0.021469|2-Sided|95.0|0.65|0.97|||Log Rank|||Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.|
1636835|NCT01975376|3008005|Superiority||LS-mean difference|1.06|||<|0.001|2-Sided|95.0|1.03|1.1|||Mixed Effect Model Repeat Measurement|||LS- mean differences and associated 95% CI, and p-values were from an MMRM model on the difference of log-transformed observations through Week 52 with fixed effects for treatment group, visit, treatment group*visit interaction, log-transformed baseline value, log-transformed baseline value*visit interaction, geographical region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL).|
1636836|NCT01975376|3008006|Superiority||LS-mean difference|0.81|||<|0.001|2-Sided|95.0|0.8|0.81|||Mixed Effect Model Repeat Measurement|||Triglycerides: LS- mean differences and associated 95% CI, and p-values were from an MMRM model through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group*visit interaction, log-transformed baseline value, log-transformed baseline value*visit interaction, geographical region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL).|
1636837|NCT01975376|3008006|Superiority||LS-mean difference|0.67|||<|0.001|2-Sided|95.0|0.66|0.68|||Mixed Effect Model Repeat Measurement|||Lp (a): LS- mean differences and associated 95% CI, and p-values were from an MMRM model on the difference of log-transformed observations through Week 52 with fixed effects for treatment group, visit, treatment group*visit interaction, log-transformed baseline value, log-transformed baseline value*visit interaction, geographical region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL).|
1636838|NCT01975376|3008007|Superiority||LS-Mean Difference|3.53|||<|0.001|2-Sided|95.0|3.02|4.03|||Mixed Effect Model Repeat Measurement|||Apo A-I: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL).|
1636839|NCT01975376|3008007|Superiority||LS-Mean Difference|6.14|||<|0.001|2-Sided|95.0|5.69|6.59|||Mixed Effect Model Repeat Measurement|||HDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL).|
1637110|NCT01972152|3008495|Superiority or Other|||||||0.16|||||||Mixed Models Analysis|Data were log transformed for analysis|||
1636840|NCT01975376|3008007|Superiority||LS-Mean Difference|-58.55|||<|0.001|2-Sided|95.0|-59.42|-57.69|||Mixed Effect Model Repeat Measurement|||Apo B: LS -mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL).|
1636841|NCT01975376|3008007|Superiority||LS-Mean Difference|-30.25|||<|0.001|2-Sided|95.0|-32.44|-28.07|||Mixed Effect Model Repeat Measurement|||RLP-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL).|
1636842|NCT01975376|3008007|Superiority||LS-mean difference|-20.17|||<|0.001|2-Sided|95.0|-21.42|-18.93|||Mixed Effect Model Repeat Measurement|||VLDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL).|
1636843|NCT01975376|3008007|Superiority||LS-mean difference|-36.51|||<|0.001|2-Sided|95.0|-37.07|-35.95|||Mixed Effect Model Repeat Measurement|||Total cholesterol: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL).|
1636844|NCT01975376|3008007|Superiority||LS-mean difference|-54.88|||<|0.001|2-Sided|95.0|-55.66|-54.09|||Mixed Effect Model Repeat Measurement|||Non-HDL-C: LS- mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL).|
1636845|NCT01975376|3008008|Superiority||LS-mean difference|-46.72|||<|0.001|2-Sided|95.0|-47.68|-45.76|||ANCOVA|||LS- mean difference and associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL).|
1636846|NCT01975376|3008009|Superiority||LS-mean difference|-54.7|||<|0.001|2-Sided|95.0|-55.48|-53.92|||Mixed Effect Model Repeat Measurement|||LS- mean differences and associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL).|
1636847|NCT01975376|3008010|Superiority||LS-mean difference|-60.57|||<|0.001|2-Sided|95.0|-61.43|-59.71|||Mixed Effect Model Repeat Measurement|||Lease Square (LS)- mean differences, associated 95% CI, and p-values were from a mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL).|
1636848|NCT01975376|3008011|Superiority||Hazard Ratio (HR)|1.12||||0.526269|2-Sided|95.0|0.79|1.6|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636849|NCT01975376|3008012|Superiority||Hazard Ratio (HR)|1.03||||0.874835|2-Sided|95.0|0.74|1.42|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636850|NCT01975376|3008013|Superiority||Hazard Ratio (HR)|0.88||||0.308388|2-Sided|95.0|0.69|1.13|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636851|NCT01975376|3008014|Superiority||Hazard Ratio (HR)|1.04||||0.889065|2-Sided|95.0|0.59|1.85|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636852|NCT01975376|3008015|Superiority||Hazard Ratio (HR)|0.9||||0.343817|2-Sided|95.0|0.71|1.12|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636853|NCT01975376|3008016|Superiority||Hazard Ratio (HR)|0.85||||0.443081|2-Sided|95.0|0.56|1.29|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636854|NCT01975376|3008017|Superiority||Hazard Ratio (HR)|0.82||||0.367069|2-Sided|95.0|0.53|1.27|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636855|NCT01975376|3008018|Superiority||Hazard Ratio (HR)|0.52||||0.020328|2-Sided|95.0|0.3|0.91|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636856|NCT01975376|3008019|Superiority||Hazard Ratio (HR)|0.5||||0.316066|2-Sided|95.0|0.12|2.0|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636857|NCT01975376|3008020|Superiority||Hazard Ratio (HR)|0.54||||0.011863|2-Sided|95.0|0.33|0.88|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636858|NCT01975376|3008021|Superiority||Hazard Ratio (HR)|0.53||||0.015462|2-Sided|95.0|0.32|0.89|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636859|NCT01975376|3008022|Superiority||Hazard Ratio (HR)|1.11||||0.46765|2-Sided|95.0|0.83|1.48|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636860|NCT01975376|3008023|Superiority||Hazard Ratio (HR)|1.54||||0.633022|2-Sided|95.0|0.26|9.23|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636861|NCT01975376|3008024|Superiority||Hazard Ratio (HR)|1.11||||0.469496|2-Sided|95.0|0.84|1.48|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636862|NCT01975376|3008025|Superiority||Hazard Ratio (HR)|1.2||||0.45569|2-Sided|95.0|0.74|1.95|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636863|NCT01975376|3008026|Superiority||Hazard Ratio (HR)|0.98||||0.883797|2-Sided|95.0|0.8|1.21|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636864|NCT01975376|3008027|Superiority||Hazard Ratio (HR)|0.82||||0.431903|2-Sided|95.0|0.49|1.36|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636865|NCT01975376|3008028|Superiority||Hazard Ratio (HR)|1.02||||0.845797|2-Sided|95.0|0.83|1.26|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636866|NCT01975376|3008029|Superiority||Hazard Ratio (HR)|0.99||||0.892441|2-Sided|95.0|0.81|1.2|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636867|NCT01975376|3008030|Superiority||Hazard Ratio (HR)|1.03||||0.784265|2-Sided|95.0|0.82|1.3|||Log Rank|||Hazard ratio and 95% CI were from a Cox proportional hazards model stratified by geographic region and LDL-C at pre-screening (<100 mg/dL, >=100 mg/dL) with treatment as a covariate.|
1636868|NCT01975376|3008031|Superiority||Hazard Ratio (HR)|0.99||||0.930905|2-Sided|95.0|0.8|1.22|||Log Rank|||Hazard ratio and 95 percent (%) Confidence Interval (CI) were from a Cox proportional hazards model stratified by geographic region and low density lipoprotein cholesterol (LDL-C) at pre-screening (less than [<] 100 milligrams per deciliters [mg/dL], greater than and equal to [>=] 100 mg/dL) with treatment as a co-variate.|
1636869|NCT01975246|3008037|Superiority or Other||Odds Ratio (OR)|2.1|||<|0.0051|2-Sided|95.0|1.2|3.4|||Regression, Logistic|Logistic regression model includes treatment and center as fixed effects.||The Non-completers considered failure (NCF) method was applied for missing data, where missing data due to early discontinuation will be replaced as “failure” up to the planned final visit to be reached by all patients.|
1636870|NCT01975246|3008038|Superiority or Other||Mean Difference (Final Values)|-5.3|Standard Error of the Mean|1.1|<|0.0001|2-Sided|95.0|-7.6|-3.1|||ANCOVA|Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.||The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.|
1636871|NCT01975246|3008039|Superiority or Other||Mean Difference (Final Values)|-3.9|Standard Error of the Mean|0.7|<|0.0001|2-Sided|95.0|-5.3|-2.4|||ANCOVA|Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.||The last observation carried forward (LOCF) method was applied for missing data, where the value from the measurements at the closest preceding visit replaced the missing value.|
1636872|NCT01975220|3008040|Non-Inferiority or Equivalence|No formal testing.|Adjusted geometric mean ratio (%)|101.06|Standard Deviation|24.4||0.0029|2-Sided|90.0|89.7|113.86|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."||
1636873|NCT01975220|3008040|Non-Inferiority or Equivalence|No formal testing.|Adjusted geometric mean ratio (%)|99.63|Standard Deviation|7.1|<|0.0001|2-Sided|90.0|96.21|103.17|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."||
1636874|NCT01975220|3008040|Non-Inferiority or Equivalence|No formal testing.|Adjusted geometric mean ratio (%)|95.4|Standard Deviation|29.4|<|0.0254|2-Sided|90.0|82.42|110.44|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).||
1636875|NCT01975220|3008041|Non-Inferiority or Equivalence|No formal testing.|Adjusted geometric mean ratio (%)|97.68|Standard Deviation|23.8||0.0037|2-Sided|90.0|86.942|109.734|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."||
1636876|NCT01975220|3008041|Non-Inferiority or Equivalence|No formal testing.|Adjusted geometric mean ratio (%)|110.17|Standard Deviation|12.0||0.0007|2-Sided|90.0|103.809|116.926|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."||
1636877|NCT01975220|3008041|Non-Inferiority or Equivalence|No formal testing.|Adjusted geometric mean ratio (%)|96.65|Standard Deviation|29.8||0.0198|2-Sided|90.0|83.337|112.079|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).||
1636878|NCT01975220|3008042|Non-Inferiority or Equivalence|No formal testing|Adjusted geometric mean ratio (%)|105.37|Standard Deviation|17.7||0.0014|2-Sided|90.0|96.6|114.942|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."||
1637111|NCT01972152|3008496|Superiority or Other|||||||0.02|||||||Mixed Models Analysis||||
1636879|NCT01975220|3008042|Non-Inferiority or Equivalence|No formal testing|Adjusted geometric mean ratio (%)|92.42|Standard Deviation|12.5||0.0004|2-Sided|90.0|86.781|98.428|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."||
1636880|NCT01975220|3008042|Non-Inferiority or Equivalence|No formal testing|Adjusted geometric mean ratio (%)|109.07|Standard Deviation|17.4||0.0072|2-Sided|90.0|99.892|119.1|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).||
1636881|NCT01975220|3008043|Non-Inferiority or Equivalence|No formal testing.|Adjusted geometric mean ratio (%)|100.78|Standard Deviation|4.9|<|0.0001|2-Sided|90.0|98.36|103.27|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."||
1636882|NCT01975220|3008043|Non-Inferiority or Equivalence|No formal testing.|Adjusted geometric mean ratio (%)|97.01|Standard Deviation|7.0|<|0.0001|2-Sided|90.0|93.622|100.531|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."||
1636883|NCT01975220|3008043|Non-Inferiority or Equivalence|No formal testing.|Adjusted geometric mean ratio (%)|100.1|Standard Deviation|5.1|<|0.0001|2-Sided|90.0|97.555|102.719|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).||
1636884|NCT01975220|3008044|Non-Inferiority or Equivalence|No formal testing|Adjusted geometric mean ratio (%)|99.76|Standard Deviation|24.2||0.002|2-Sided|90.0|88.65|112.27|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."||
1636885|NCT01975220|3008044|Non-Inferiority or Equivalence|No formal testing|Adjusted geometric mean ratio (%)|99.69|Standard Deviation|7.1|<|0.0001|2-Sided|90.0|96.25|103.26|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."||
1636886|NCT01975220|3008044|Non-Inferiority or Equivalence|No formal testing|Adjusted geometric mean ratio (%)|94.65|Standard Deviation|28.1|<|0.0256|2-Sided|90.0|82.29|108.88|||ANOVA||The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fasted: 1 FDC tablet' divided by the geometric mean of 'High dose, fasted: 3 single tablets'. The 'standard deviation' is actually the intra-individual gCV (%).||
1636887|NCT01975220|3008045|Non-Inferiority or Equivalence|No formal testing|Adjusted geometric mean ratio (%)|100.7|Standard Deviation|4.9|<|0.0001|2-Sided|90.0|98.28|103.18|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'Low dose, fasted: 2 FDC tablets' divided by the geometric mean of 'Low dose, fasted: 4 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."||
1636888|NCT01975220|3008045|Non-Inferiority or Equivalence|No formal testing|Adjusted geometric mean ratio (%)|97.09|Standard Deviation|6.7|<|0.0001|2-Sided|90.0|93.857|100.436|||ANOVA||"The adjusted geometric mean ratio (%) was calculated as the geometric mean of 'High dose, fed: 1 FDC tablet' divided by the geometric mean of 'High dose, fed: 3 single tablets'.~The 'standard deviation' is actually the intra-individual gCV (%)."||
1636889|NCT01975220|3008045|Non-Inferiority or Equivalence|No formal testing|Adjusted geometric mean ratio (%)|99.98|Standard Deviation|5.4|<|0.0001|2-Sided|90.0|97.275|102.751|||ANOVA||Adjusted geometric mean (GM) ratio(%) was calculated as GM of 'High dose, fasted:1 FDC tablet' divided by GM of 'High dose, fasted:3 single tablets’.The 'standard deviation' is actually intra-individual geometric coefficient of variation (gCV (%)).||
1636890|NCT01974752|3008062|Superiority or Other||Hazard Ratio (HR)|0.75||||0.4011|2-Sided|95.0|0.39|1.46|||Log Rank||||
1636891|NCT01974752|3008063|Superiority or Other||Geometric LS mean ratio|0.94||||0.1284|2-Sided|95.0|0.88|1.02|||ANCOVA|ANCOVA of log (W6/BL) tumour assessments with a factor for trt, and covariates for liver mets, log BL tumour size, and time from BL scan to rand.|A geometric least squares mean ratio < 1 favours Selumetinib in combination with Dacarbazine||
1636892|NCT01974752|3008065|Superiority or Other||Hazard Ratio (HR)|0.78||||0.3195|2-Sided|95.0|0.48|1.27|||Log Rank|Factor for treatment and liver metastases|A hazard ratio < 1 favours Selumetinib in combination with Dacarbazine||
1636893|NCT01973998|3008187|Superiority||Hazard Ratio (HR)|1.654|Standard Deviation|0.4789||0.1|2-Sided|10.0|1.175|2.133|||Log Rank|||A total of 100 patients is required in a 2 treatment parallel-design study. There is a 70% probability that the study will detect a treatment difference at a 2-sided 10% significance level, if the true hazard ratio is 1.654. This is based on the assumption that the accrual period will be 36 months and the follow up period will be 6 months and the median time to event is 8 months. The total number of events will be 73.|
1636894|NCT01973998|3008187|Equivalence|The primary outcome is time from randomization to a composite outcome of all cause re-hospitalization and all-cause mortality, whichever comes first. The primary analysis will be a log-ranked test and associated Kaplan-Meier plot, unadjusted for any covariates|Hazard Ratio (HR)|1.654|Standard Deviation|0.4789|<|0.1|2-Sided|10.0|1.175|2.133||Because this is a pilot study the intent is to see if there is a signal that would justify a larger clinical trial. Therefore the significance level has been set to 0.1 and the power has been set at 0.7.|Log Rank||||
1636895|NCT01973569|3008203|Superiority||Mean Difference (Net)|5.02|||<|0.0001|2-Sided|95.0|4.41|5.63|||Regression, Cox|ANCOVA model adjusting for treatment, baseline (BL) value, machine type, BL value-by-machine type interaction, and BL use of glucocorticoid was used.|||
1636896|NCT01973569|3008204|Superiority|||||||0.257|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.|||
1636897|NCT01973569|3008205|Superiority|||||||0.0104|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.|||
1637112|NCT01972152|3008496|Superiority or Other|||||||0.68|||||||Mixed Models Analysis||||
1636899|NCT01973569|3008207|Superiority|||||||0.1323|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.|||
1636900|NCT01973569|3008208|Superiority|||||||0.036|||||||van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.|||
1636901|NCT01973569|3008209|Superiority|||||||0.0235||||||The hierarchical testing procedure was applied for multiple comparisons of the primary endpoint. First, comparison between AMG 162 60mg Q3M vs placebo is tested. Only if it is rejected, comparison of AMG 162 60mg Q6M vs placebo is formally tested.|van Elteren stratified rank test|van Elteren stratified rank test adjusting for baseline use of glucocorticoid was used.|||
1636902|NCT01973413|3008228|Superiority or Other||||||=|0|||||||Wilcoxon (Mann-Whitney)||||
1636903|NCT01973413|3008229|Non-Inferiority or Equivalence|Significance level of 0.05, 90% power, required 48 nights of OCL and 48 control nights to detect a 20% improvement.|||||=|0|||||||Wilcoxon (Mann-Whitney)||||
1636904|NCT01973387|3008234|Superiority or Other||Hazard Ratio (HR)|0.178|||<|0.0001|2-Sided|95.0|0.109|0.291|||Log Rank||||
1636905|NCT01973348|3008237|Non-Inferiority or Equivalence|A sample size of 12 subjects per group has been shown to be effective for estimating within-group means and variances when little prior data is available.(Julius, 2005) Based on collected data from 34 subjects and effective size difference of 0.1, we reestimate this study as a noninferiority trial with continuous outcome and power calculated as approximately 80%.||||||0.88|||||||t-test, 1 sided||||
1636906|NCT01973335|3008257|Superiority||Risk Difference (RD)|-0.2||||0.27|2-Sided|||||Not adjusted for multiple comparisons|Fisher Exact|||2x2 factorial design: analysis according to spironolactone use|
1636907|NCT01973335|3008258|Superiority||Mean Difference (Final Values)|30.0||||0.515|2-Sided|95.0|-63.0|123.0||Not adjusted for multiple comparisons|t-test, 2 sided|||2x2 factorial design: both acetazolamide groups together are compared with both high-dose loop diuretic groups together|
1636908|NCT01972841|3008315|Superiority||Odds Ratio (OR)|1.45||||0.005|2-Sided|95.0|1.12|1.87|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.|
1636909|NCT01972841|3008315|Superiority||Odds Ratio (OR)|1.66|||<|0.001|2-Sided|95.0|1.28|2.16|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.|
1636910|NCT01972841|3008315|Superiority||Odds Ratio (OR)|1.23|||<|0.105|2-Sided|95.0|0.96|1.59|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.|
1636911|NCT01972841|3008315|Superiority||Odds Ratio (OR)|1.11|||<|0.416|2-Sided|95.0|0.86|1.43|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.|
1636912|NCT01972841|3008316|Superiority||Odds Ratio (OR)|1.71|||<|0.001|2-Sided|95.0|1.33|2.21|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.|
1636913|NCT01972841|3008316|Superiority||Odds Ratio (OR)|1.56|||<|0.001|2-Sided|95.0|1.21|2.02|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.|
1636914|NCT01972841|3008316|Superiority||Odds Ratio (OR)|1.4|||<|0.009|2-Sided|95.0|1.09|1.81|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.|
1636915|NCT01972841|3008316|Superiority||Odds Ratio (OR)|1.13|||<|0.335|2-Sided|95.0|0.88|1.46|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.|
1636916|NCT01972841|3008317|Superiority||Odds Ratio (OR)|1.59|||<|0.001|2-Sided|95.0|1.23|2.05|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.|
1636917|NCT01972841|3008317|Superiority||Odds Ratio (OR)|1.59|||<|0.001|2-Sided|95.0|1.23|2.06|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.|
1636918|NCT01972841|3008317|Superiority||Odds Ratio (OR)|1.46|||<|0.004|2-Sided|95.0|1.13|1.89|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.|
1636919|NCT01972841|3008317|Superiority||Odds Ratio (OR)|1.18|||<|0.21|2-Sided|95.0|0.91|1.52|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.|
1637113|NCT01972152|3008497|Superiority or Other|||||||0.76|||||||Mixed Models Analysis||||
1636920|NCT01972841|3008318|Superiority||Odds Ratio (OR)|1.27||||0.067|2-Sided|95.0|0.98|1.63|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.|
1636921|NCT01972841|3008318|Superiority||Odds Ratio (OR)|1.66|||<|0.001|2-Sided|95.0|1.29|2.13|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.|
1636922|NCT01972841|3008318|Superiority||Odds Ratio (OR)|1.26|||<|0.073|2-Sided|95.0|0.98|1.62|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.|
1636923|NCT01972841|3008318|Superiority||Odds Ratio (OR)|1.24|||<|0.095|2-Sided|95.0|0.96|1.59|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.|
1636924|NCT01972841|3008319|Superiority||Odds Ratio (OR)|1.57||||0.001|2-Sided|95.0|1.21|2.03|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.|
1636925|NCT01972841|3008319|Superiority||Odds Ratio (OR)|1.56||||0.001|2-Sided|95.0|1.21|2.0|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.|
1636926|NCT01972841|3008319|Superiority||Odds Ratio (OR)|1.31||||0.04|2-Sided|95.0|1.01|1.7|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.|
1636927|NCT01972841|3008319|Superiority||Odds Ratio (OR)|1.12||||0.381|2-Sided|95.0|0.87|1.45|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.|
1636928|NCT01972841|3008320|Superiority||Odds Ratio (OR)|1.68|||<|0.001|2-Sided|95.0|1.29|2.19|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.|
1636929|NCT01972841|3008320|Superiority||Odds Ratio (OR)|1.76|||<|0.001|2-Sided|95.0|1.34|2.3|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.|
1636930|NCT01972841|3008320|Superiority||Odds Ratio (OR)|1.67|||<|0.001|2-Sided|95.0|1.28|2.17|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.|
1636931|NCT01972841|3008320|Superiority||Odds Ratio (OR)|1.44|||<|0.007|2-Sided|95.0|1.11|1.87|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.|
1636932|NCT01972841|3008321|Superiority||Odds Ratio (OR)|1.51||||0.007|2-Sided|95.0|1.12|2.04|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.|
1636933|NCT01972841|3008321|Superiority||Odds Ratio (OR)|1.76|||<|0.001|2-Sided|95.0|1.32|2.36|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.|
1636934|NCT01972841|3008321|Superiority||Odds Ratio (OR)|1.68|||<|0.001|2-Sided|95.0|1.24|2.27|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.|
1636935|NCT01972841|3008321|Superiority||Odds Ratio (OR)|1.32|||<|0.065|2-Sided|95.0|0.98|1.78|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.|
1636936|NCT01972841|3008322|Superiority||Odds Ratio (OR)|1.57||||0.001|2-Sided|95.0|1.21|2.04|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.|
1636937|NCT01972841|3008322|Superiority||Odds Ratio (OR)|1.59||||0.001|2-Sided|95.0|1.22|2.07|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.|
1636938|NCT01972841|3008322|Superiority||Odds Ratio (OR)|1.62|||<|0.001|2-Sided|95.0|1.24|2.11|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.|
1637114|NCT01972152|3008498|Superiority or Other|||||||0.95|||||||Mixed Models Analysis||||
1638256|NCT01948310|3011459|Superiority||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks|
1636939|NCT01972841|3008322|Superiority||Odds Ratio (OR)|1.47|||<|0.004|2-Sided|95.0|1.13|1.92|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.|
1636940|NCT01972841|3008323|Superiority||Odds Ratio (OR)|1.6|||<|0.001|2-Sided|95.0|1.23|2.08|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1636941|NCT01972841|3008323|Superiority||Odds Ratio (OR)|1.47|||<|0.004|2-Sided|95.0|1.13|1.9|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1636942|NCT01972841|3008323|Superiority||Odds Ratio (OR)|1.43|||<|0.006|2-Sided|95.0|1.11|1.84|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1636943|NCT01972841|3008323|Superiority||Odds Ratio (OR)|1.3|||<|0.044|2-Sided|95.0|1.01|1.67|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1636944|NCT01972841|3008324|Superiority||Odds Ratio (OR)|1.41||||0.012|2-Sided|95.0|1.08|1.85|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.|
1636945|NCT01972841|3008324|Superiority||Odds Ratio (OR)|1.59|||<|0.001|2-Sided|95.0|1.23|2.07|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.|
1636946|NCT01972841|3008324|Superiority||Odds Ratio (OR)|1.25|||<|0.107|2-Sided|95.0|0.95|1.64|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.|
1636947|NCT01972841|3008324|Superiority||Odds Ratio (OR)|1.17|||<|0.251|2-Sided|95.0|0.89|1.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.|
1636948|NCT01972841|3008325|Superiority||Odds Ratio (OR)|1.16||||0.294|2-Sided|95.0|0.88|1.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.|
1636949|NCT01972841|3008325|Superiority||Odds Ratio (OR)|1.92|||<|0.001|2-Sided|95.0|1.46|2.53|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.|
1636950|NCT01972841|3008325|Superiority||Odds Ratio (OR)|1.15|||<|0.321|2-Sided|95.0|0.87|1.53|||Logistic regression|||Odds ratio from a logistic regression model treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.|
1636951|NCT01972841|3008325|Superiority||Odds Ratio (OR)|1.29|||<|0.077|2-Sided|95.0|0.97|1.72|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.|
1636952|NCT01972841|3008326|Superiority||Odds Ratio (OR)|1.65||||0.002|2-Sided|95.0|1.21|2.26|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.|
1636953|NCT01972841|3008326|Superiority||Odds Ratio (OR)|1.98|||<|0.001|2-Sided|95.0|1.47|2.67|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.|
1636954|NCT01972841|3008326|Superiority||Odds Ratio (OR)|1.42|||<|0.037|2-Sided|95.0|1.02|1.96|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.|
1636955|NCT01972841|3008326|Superiority||Odds Ratio (OR)|1.22|||<|0.224|2-Sided|95.0|0.88|1.69|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.|
1636956|NCT01972841|3008327|Superiority||Odds Ratio (OR)|1.34||||0.023|2-Sided|95.0|1.04|1.73|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.|
1636957|NCT01972841|3008327|Superiority||Odds Ratio (OR)|1.5||||0.002|2-Sided|95.0|1.16|1.93|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.|
1637115|NCT01972152|3008499|Superiority or Other|||||||0.01||||||Data were log transformed for analysis.|Mixed Models Analysis||||
1637116|NCT01972152|3008499|Superiority or Other|||||||0.34||||||Data were log transformed for analysis.|Mixed Models Analysis||||
1636958|NCT01972841|3008327|Superiority||Odds Ratio (OR)|1.4||||0.009|2-Sided|95.0|1.09|1.81|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.|
1636959|NCT01972841|3008327|Superiority||Odds Ratio (OR)|1.31||||0.035|2-Sided|95.0|1.02|1.69|||Logistic regression|||Odds ratio from a logistic regression model including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.|
1636960|NCT01972841|3008340|Superiority||Least squares mean difference|0.95|Standard Error of the Mean|0.99||0.337|2-Sided|95.0|-0.99|2.89|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636961|NCT01972841|3008340|Superiority||Least squares mean difference|2.8|Standard Error of the Mean|0.99||0.005|2-Sided|95.0|0.85|4.74|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636962|NCT01972841|3008340|Superiority||Least squares mean difference|2.25|Standard Error of the Mean|0.99||0.023|2-Sided|95.0|0.31|4.19|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636963|NCT01972841|3008340|Superiority||Least squares mean difference|2.27|Standard Error of the Mean|0.99||0.022|2-Sided|95.0|0.33|4.21|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636964|NCT01972841|3008341|Superiority||Least squares mean difference|3.28|Standard Error of the Mean|1.24||0.008|2-Sided|95.0|0.84|5.72|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636965|NCT01972841|3008341|Superiority||Least squares mean difference|4.87|Standard Error of the Mean|1.25|<|0.001|2-Sided|95.0|2.42|7.32|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636966|NCT01972841|3008341|Superiority||Least squares mean difference|4.42|Standard Error of the Mean|1.24|<|0.001|2-Sided|95.0|1.98|6.86|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636967|NCT01972841|3008341|Superiority||Least squares mean difference|4.42|Standard Error of the Mean|1.24|<|0.001|2-Sided|95.0|1.98|6.85|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636968|NCT01972841|3008342|Superiority||Least squares mean difference|4.41|Standard Error of the Mean|1.22|<|0.001|2-Sided|95.0|2.01|6.81|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636969|NCT01972841|3008342|Superiority||Least squares mean difference|5.34|Standard Error of the Mean|1.23|<|0.001|2-Sided|95.0|2.93|7.75|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636970|NCT01972841|3008342|Superiority||Least squares mean difference|4.82|Standard Error of the Mean|1.22|<|0.001|2-Sided|95.0|2.42|7.22|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636971|NCT01972841|3008342|Superiority||Least squares mean difference|4.24|Standard Error of the Mean|1.22|<|0.001|2-Sided|95.0|1.84|6.63|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637117|NCT01972152|3008500|Superiority or Other|||||||0.24|||||||Mixed Models Analysis|Data were log transformed for analysis.|||
1636972|NCT01972841|3008343|Superiority||Least squares mean difference|3.8|Standard Error of the Mean|1.29||0.003|2-Sided|95.0|1.27|6.33|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636973|NCT01972841|3008343|Superiority||Least squares mean difference|6.09|Standard Error of the Mean|1.3|<|0.001|2-Sided|95.0|3.55|8.63|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636974|NCT01972841|3008343|Superiority||Lest squares mean difference|4.87|Standard Error of the Mean|1.29|<|0.001|2-Sided|95.0|2.34|7.4|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636975|NCT01972841|3008343|Superiority||Least squares mean difference|4.12|Standard Error of the Mean|1.29|<|0.001|2-Sided|95.0|1.6|6.65|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636976|NCT01972841|3008344|Superiority||Least squares mean difference|3.3|Standard Error of the Mean|1.09||0.002|2-Sided|95.0|1.17|5.43|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636977|NCT01972841|3008344|Superiority||Least squares mean difference|5.02|Standard Error of the Mean|1.09|<|0.001|2-Sided|95.0|2.88|7.15|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636978|NCT01972841|3008344|Superiority||Least squares mean difference|4.16|Standard Error of the Mean|1.09|<|0.001|2-Sided|95.0|2.03|6.29|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636979|NCT01972841|3008344|Superiority||Least squares mean difference|3.81|Standard Error of the Mean|1.08|<|0.001|2-Sided|95.0|1.69|5.94|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636980|NCT01972841|3008346|Superiority||Least squares mean difference|-0.35|Standard Error of the Mean|0.07|<|0.001|2-Sided|95.0|-0.5|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636981|NCT01972841|3008346|Superiority||Least squares mean difference|-0.35|Standard Error of the Mean|0.07|<|0.001|2-Sided|95.0|-0.5|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636982|NCT01972841|3008346|Superiority||Least squares mean difference|-0.39|Standard Error of the Mean|0.07|<|0.001|2-Sided|95.0|-0.54|-0.25|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636983|NCT01972841|3008346|Superiority||Least squares mean difference|-0.26|Standard Error of the Mean|0.07|<|0.001|2-Sided|95.0|-0.41|-0.11|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636984|NCT01972841|3008347|Superiority||Odds Ratio (OR)|1.66|||<|0.001|2-Sided|95.0|1.33|2.07|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1636985|NCT01972841|3008347|Superiority||Odds Ratio (OR)|1.65|||<|0.001|2-Sided|95.0|1.32|2.06|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1637118|NCT01971723|3008507|Superiority or Other|||||||0.05|||||||ANOVA||||
1637119|NCT01971723|3008508|Superiority or Other||||||>|0.05|||||||ANOVA||||
1636986|NCT01972841|3008347|Superiority||Odds Ratio (OR)|1.41|||<|0.002|2-Sided|95.0|1.14|1.75|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1636987|NCT01972841|3008347|Superiority||Odds Ratio (OR)|1.32|||<|0.011|2-Sided|95.0|1.07|1.64|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1636988|NCT01972841|3008348|Superiority||Odds Ratio (OR)|1.5|||<|0.001|2-Sided|95.0|1.23|1.84|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate|
1636989|NCT01972841|3008348|Superiority||Odds Ratio (OR)|1.45|||<|0.001|2-Sided|95.0|1.19|1.77|||overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1636990|NCT01972841|3008348|Superiority||Odds Ratio (OR)|1.3|||<|0.009|2-Sided|95.0|1.07|1.59|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1636991|NCT01972841|3008348|Superiority||Odds Ratio (OR)|1.23|||<|0.039|2-Sided|95.0|1.01|1.5|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.|
1636992|NCT01972841|3008349|Superiority||Odds Ratio (OR)|1.36||||0.004|2-Sided|95.0|1.1|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.|
1636993|NCT01972841|3008349|Superiority||Odds Ratio (OR)|1.59|||<|0.001|2-Sided|95.0|1.29|1.95|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.|
1636994|NCT01972841|3008349|Superiority||Odds Ratio (OR)|1.36|||<|0.004|2-Sided|95.0|1.11|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.|
1636995|NCT01972841|3008349|Superiority||Odds Ratio (OR)|1.37|||<|0.003|2-Sided|95.0|1.11|1.68|||Overdispersed binomial regression|||Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.|
1636996|NCT01972841|3008350|Superiority||Least squares mean difference|-0.18|Standard Error of the Mean|0.13||0.169|2-Sided|95.0|-0.43|0.08|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate|
1636997|NCT01972841|3008350|Superiority||Least squares mean difference|-0.27|Standard Error of the Mean|0.13||0.035|2-Sided|95.0|-0.52|-0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636998|NCT01972841|3008350|Superiority||Least squares mean difference|-0.06|Standard Error of the Mean|0.13||0.65|2-Sided|95.0|-0.3|0.19|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1636999|NCT01972841|3008350|Superiority||Least squares mean difference|0.0|Standard Error of the Mean|0.13||0.993|2-Sided|95.0|-0.25|0.25|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637000|NCT01972841|3008351|Superiority||Least squares mean difference|-1.41|Standard Error of the Mean|0.88||0.108|2-Sided|95.0|-3.13|0.31|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637079|NCT01972789|3008382|Non-Inferiority|This is a non-inferiority study design, with a pre-specified non-inferiority margin of 5 letters between intensive and relaxed groups. That is, if the change from Baseline in BCVA at Month 24 in the intensive group is not more than 5 letters higher than the relaxed group, then the relaxed group is regarded not inferior to the intensive group|Odds Ratio (OR)|0.4||||0.787|2-Sided|95.0|-2.51|3.32|||Mixed Models Analysis||||
1637001|NCT01972841|3008351|Superiority||Least squares mean difference|-1.91|Standard Error of the Mean|0.87||0.028|2-Sided|95.0|-3.62|-0.2|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637002|NCT01972841|3008351|Superiority||Least squares mean difference|-0.58|Standard Error of the Mean|0.86||0.5|2-Sided|95.0|-2.27|1.11|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637003|NCT01972841|3008351|Superiority||Least squares mean difference|-0.04|Standard Error of the Mean|0.86||0.958|2-Sided|95.0|-1.73|1.64|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637004|NCT01972841|3008352|Superiority||Rate ratio|0.8|Standard Error of the Mean|0.12||0.069|2-Sided|95.0|0.64|1.02|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.|
1637005|NCT01972841|3008352|Superiority||Standard Error of the Mean|0.73|Standard Error of the Mean|0.12||0.008|2-Sided|95.0|0.58|0.92|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.|
1637006|NCT01972841|3008352|Superiority||Rate ratio|1.0|Standard Error of the Mean|0.12||0.967|2-Sided|95.0|0.79|1.25|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.|
1637007|NCT01972841|3008352|Superiority||Rate ratio|1.01|Standard Error of the Mean|0.12||0.938|2-Sided|95.0|0.8|1.27|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.|
1637008|NCT01972841|3008353|Superiority||Least squares mean difference|-0.17|Standard Error of the Mean|0.05||0.001|2-Sided|95.0|-0.26|-0.07|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637009|NCT01972841|3008353|Superiority||Least squares mean difference|-0.08|Standard Error of the Mean|0.05||0.1|2-Sided|95.0|-0.18|0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637010|NCT01972841|3008353|Superiority||Least squares mean difference|-0.17|Standard Error of the Mean|0.05||0.001|2-Sided|95.0|-0.26|-0.07|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637011|NCT01972841|3008353|Superiority||Least squares mean difference|-0.09|Standard Error of the Mean|0.05||0.065|2-Sided|95.0|-0.19|0.01|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637012|NCT01972841|3008354|Superiority||Least squares mean difference|-1.21|Standard Error of the Mean|0.34|<|0.001|2-Sided|95.0|-1.88|-0.54|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637013|NCT01972841|3008354|Superiority||Least squares mean difference|-0.51|Standard Error of the Mean|0.34|<|0.14|2-Sided|95.0|-1.18|0.17|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637120|NCT01971723|3008509|Superiority or Other||||||>|0.05|||||||ANOVA||||
1637014|NCT01972841|3008354|Superiority||Least squares mean difference|-1.16|Standard Error of the Mean|0.34|<|0.001|2-Sided|95.0|-1.83|-0.48|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637015|NCT01972841|3008354|Superiority||Least squares mean difference|-0.61|Standard Error of the Mean|0.34|<|0.073|2-Sided|95.0|-1.28|0.06|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637016|NCT01972841|3008355|Superiority||Rate ratio|0.86|Standard Error of the Mean|0.05||0.001|2-Sided|95.0|0.79|0.94|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.|
1637017|NCT01972841|3008355|Superiority||Rate ratio|0.91|Standard Error of the Mean|0.05||0.049|2-Sided|95.0|0.84|1.0|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.|
1637018|NCT01972841|3008355|Superiority||Rate ratio|0.81|Standard Error of the Mean|0.05|<|0.001|2-Sided|95.0|0.74|0.88|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.|
1637019|NCT01972841|3008355|Superiority||Rate ratio|0.88|Standard Error of the Mean|0.05|<|0.006|2-Sided|95.0|0.81|0.96|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, >=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.|
1637020|NCT01972841|3008356|Superiority||Least squares mean difference|-0.87|Standard Error of the Mean|0.19|<|0.001|2-Sided|95.0|-1.24|0.51|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637021|NCT01972841|3008356|Superiority||Least squares mean difference|-0.65|Standard Error of the Mean|0.18|<|0.001|2-Sided|95.0|-1.01|-0.28|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637022|NCT01972841|3008356|Superiority||Least squares mean difference|-0.45|Standard Error of the Mean|0.18|<|0.014|2-Sided|95.0|-0.82|-0.09|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637023|NCT01972841|3008356|Superiority||Least squares mean difference|-0.33|Standard Error of the Mean|0.18|<|0.074|2-Sided|95.0|-0.69|0.03|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637024|NCT01972841|3008357|Superiority||Standard Error of the Mean|-0.32|Standard Error of the Mean|0.11||0.019|2-Sided|5.0|-0.54|-0.1|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50mg ) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637025|NCT01972841|3008357|Superiority||Least squares mean diffeence|-0.37|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|-0.59|-0.15|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637026|NCT01972841|3008357|Superiority||Least squares mean difference|-0.23|Standard Error of the Mean|0.11|<|0.043|2-Sided|95.0|-0.45|-0.02|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1638160|NCT01951326|3011111|Superiority|||||||0.151|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).|||
1637027|NCT01972841|3008357|Superiority||Least squares mean difference|-0.24|Standard Error of the Mean|0.11|<|0.134|2-Sided|95.0|-0.46|-0.02|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637028|NCT01972841|3008358|Superiority||Least squares mean difference|-2.21|Standard Error of the Mean|0.76||0.012|2-Sided|95.0|-3.7|-0.71|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637029|NCT01972841|3008358|Superiority||Least squares mean difference|-2.61|Standard Error of the Mean|0.76|<|0.001|2-Sided|95.0|-4.09|-1.12|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637030|NCT01972841|3008358|Superiority||Least squares mean difference|-1.62|Standard Error of the Mean|0.76|<|0.034|2-Sided|95.0|-3.1|-0.13|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637031|NCT01972841|3008358|Superiority||Least squares mean difference|-1.61|Standard Error of the Mean|0.76|<|0.114|2-Sided|95.0|-3.09|-0.13|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637032|NCT01972841|3008359|Superiority||Rate ratio|0.84|Standard Error of the Mean|0.1||0.084|2-Sided|95.0|0.68|1.02|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group & the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate & postbaseline number of valid diary days as offset variable.|
1637033|NCT01972841|3008359|Superiority||Rate ratio|0.65|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|0.53|0.79|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group & the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate & postbaseline number of valid diary days as offset variable.|
1637034|NCT01972841|3008359|Superiority||Rate ratio|0.9|Standard Error of the Mean|0.1|<|0.288|2-Sided|95.0|0.73|1.1|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group & the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate & postbaseline number of valid diary days as offset variable.|
1637035|NCT01972841|3008359|Superiority||Rate ratio|0.85|Standard Error of the Mean|0.1|<|0.11|2-Sided|95.0|0.7|1.04|||Negative binomial regression|||Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group & the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate & postbaseline number of valid diary days as offset variable.|
1637036|NCT01972841|3008360|Superiority||Least squares mean diffrence|-0.56|Standard Error of the Mean|0.3||0.06|2-Sided|95.0|-1.13|0.02|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.|
1637037|NCT01972841|3008360|Superiority||Least squares mean difference|-0.92|Standard Error of the Mean|0.29||0.002|2-Sided|95.0|-1.5|-0.34|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.|
1637038|NCT01972841|3008360|Superiority||Least squares mean difference|-0.24|Standard Error of the Mean|0.29||0.413|2-Sided|95.0|-0.82|0.34|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.|
1637080|NCT01972568|3008411|Superiority or Other||Odds Ratio (OR)|1.96||||0.0202|2-Sided|95.0|1.11|3.46|||Logistic regression model||||
1637081|NCT01972568|3008412|Superiority or Other||Odds Ratio (OR)|3.31||||0.0048|2-Sided|95.0|1.44|7.61|||Logistic regression model||||
1638257|NCT01948310|3011459|Superiority||||||>|0.03|||||||t-test, 2 sided|||0-14 weeks|
1637039|NCT01972841|3008360|Superiority||Least squares mean difference|0.19|Standard Error of the Mean|0.29||0.52|2-Sided|95.0|-0.39|0.76|||ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.|
1637040|NCT01972841|3008364|Superiority||Least squares mean difference|-1.59|Standard Error of the Mean|0.84||0.024|2-Sided|95.0|-3.23|0.05|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637041|NCT01972841|3008364|Superiority||least square mean difference|-2.36|Standard Error of the Mean|0.83|<|0.001|2-Sided|95.0|-4.0|-0.73|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637042|NCT01972841|3008364|Superiority||Least squares mean difference|-1.33|Standard Error of the Mean|0.83|<|0.025|2-Sided|95.0|-2.96|0.3|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637043|NCT01972841|3008364|Superiority||least squares mean difference|-1.64|Standard Error of the Mean|0.83|<|0.074|2-Sided|95.0|-3.27|-0.01|||Stratified rank ANCOVA|||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (<65, >=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.offset variable.|
1637044|NCT01972841|3008365|Superiority||Rate ratio|0.88|Standard Error of the Mean|0.1||0.172|2-Sided|95.0|0.73|1.06|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.|
1637045|NCT01972841|3008365|Superiority||Rate ratio|0.71|Standard Error of the Mean|0.09|<|0.001|2-Sided|95.0|0.59|0.85|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.|
1637046|NCT01972841|3008365|Superiority||Rate ratio|0.9|Standard Error of the Mean|0.09|<|0.282|2-Sided|95.0|0.75|1.09|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.|
1637047|NCT01972841|3008365|Superiority||Rate ratio|0.87|Standard Error of the Mean|0.09|<|0.135|2-Sided|95.0|0.72|1.04|||Negative binomial regression|||Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.|
1637048|NCT01972841|3008366|Superiority||Least squares mean difference|0.37|Standard Error of the Mean|0.14||0.007|2-Sided|95.0|0.1|0.65|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637049|NCT01972841|3008366|Superiority||Least squares mean difference|0.37|Standard Error of the Mean|0.14||0.008|2-Sided|95.0|0.1|0.65|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637050|NCT01972841|3008366|Superiority||Least squares mean difference|0.27|Standard Error of the Mean|0.14||0.05|2-Sided|95.0|0.0|0.55|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637082|NCT01972568|3008420|Superiority or Other||Odds Ratio (OR)|1.56||||0.1208|2-Sided|95.0|0.89|2.72|||Logistic regression model||||
1637121|NCT01971723|3008510|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||This statistical analysis is for total weight lifted volume measure outcomes, only.|
1637051|NCT01972841|3008366|Superiority||Least squares mean difference|0.25|Standard Error of the Mean|0.14||0.077|2-Sided|95.0|-0.03|0.52|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637052|NCT01972841|3008367|Superiority||Least squares mean difference|-6.1|Standard Error of the Mean|1.2|<|0.001|2-Sided|95.0|-8.46|-3.74|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637053|NCT01972841|3008367|Superiority||Least squares mean difference|-7.13|Standard Error of the Mean|1.21|<|0.001|2-Sided|95.0|-9.5|-4.76|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637054|NCT01972841|3008367|Superiority||Least squares mean difference|-5.8|Standard Error of the Mean|1.21|<|0.001|2-Sided|95.0|-8.17|-3.44|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637055|NCT01972841|3008367|Superiority||Least squares mean difference|-4.63|Standard Error of the Mean|1.2|<|0.001|2-Sided|95.0|-6.98|-2.27|||ANCOVA|No adjustment for multiplicity was made for this comparison.||Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637056|NCT01972841|3008368|Superiority||Least squares mean difference|17.74|Standard Error of the Mean|3.14|<|0.001|2-Sided|95.0|11.58|23.9||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637057|NCT01972841|3008368|Superiority||Least squares mean difference|21.52|Standard Error of the Mean|3.14|<|0.001|2-Sided|95.0|15.35|27.68||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637058|NCT01972841|3008368|Superiority||Least squares mean difference|8.75|Standard Error of the Mean|3.13|<|0.005|2-Sided|95.0|2.61|14.89||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637059|NCT01972841|3008368|Superiority||Least squares mean difference|3.85|Standard Error of the Mean|3.13|<|0.219|2-Sided|95.0|-2.29|10.0||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637060|NCT01972841|3008369|Superiority||Least squares mean difference|-0.56|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-0.84|-0.28||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637106|NCT01972152|3008493|Superiority or Other||||||<|0.001||||||Data were log transformed for analysis.|Mixed Models Analysis||||
1637061|NCT01972841|3008369|Superiority||Least squares mean difference|-0.48|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-0.76|-0.21||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637062|NCT01972841|3008369|Superiority||Least squares mean difference|-0.39|Standard Error of the Mean|0.14|<|0.006|2-Sided|95.0|-0.67|-0.11||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637063|NCT01972841|3008369|Superiority||Least squares mean difference|-0.29|Standard Error of the Mean|0.14|<|0.04|2-Sided|95.0|-0.57|-0.01||Nominal p-value|ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637064|NCT01972841|3008370|Superiority||Least squares mean difference|-0.23|Standard Error of the Mean|0.12||0.052|2-Sided|95.0|-0.47|0.01|||Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637065|NCT01972841|3008370|Superiority||Least squares mean difference|-0.34|Standard Error of the Mean|0.12||0.001|2-Sided|95.0|-0.58|-0.1|||Stratified rank ANCOVA||Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637066|NCT01972841|3008370|Superiority||Least squares mean difference|-0.2|Standard Error of the Mean|0.12||0.033|2-Sided|95.0|-0.44|0.04||Nominal p-value|Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637067|NCT01972841|3008370|Superiority||Least squares mean difference|-0.25|Standard Error of the Mean|0.12||0.072|2-Sided|95.0|-0.49|-0.01||Nominal p-value|Stratified rank ANCOVA|No adjustment for multiplicity was needed for testing combination therapy vs. its 2 monotherapy components.|Adjustment for multiplicity across primary and the first secondary endpoint as well as across the 2 combination doses was made using a sequential Bonferroni-based testing procedure.|Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.|
1637068|NCT01972789|3008371|Other||Odds Ratio (OR)|1.39||||0.034|2-Sided|95.0|1.03|1.9|||Regression, Logistic||||
1637069|NCT01972789|3008372|Other||Odds Ratio (OR)|4.32||||0.565|2-Sided|95.0|0.03|630.5|||Regression, Logistic||||
1637070|NCT01972789|3008374|Other||Odds Ratio (OR)|1.08||||0.819|2-Sided|95.0|0.54|2.18|||Regression, Logistic||||
1637071|NCT01972789|3008375|Other||Odds Ratio (OR)|0.84||||0.615|2-Sided|95.0|0.42|1.66|||Regression, Logistic||||
1637072|NCT01972789|3008376|Other||Odds Ratio (OR)|0.35||||0.217|2-Sided|95.0|0.12|1.04|||Regression, Logistic||||
1637073|NCT01972789|3008377|Other||Odds Ratio (OR)|1.29||||0.407|2-Sided|95.0|0.71|2.33|||Regression, Logistic|||Month 24|
1637074|NCT01972789|3008377|Other||Odds Ratio (OR)|1.44||||0.284|2-Sided|95.0|0.74|2.8|||Regression, Logistic|||Month 12|
1637075|NCT01972789|3008378|Other||Odds Ratio (OR)|0.26||||0.338|2-Sided|95.0|-0.28|0.8|||Mixed Models Analysis||||
1637076|NCT01972789|3008379|Other||Negative Binomial Regression|1.11||||0.001|2-Sided|95.0|1.04|1.18|||Mixed Model||||
1637077|NCT01972789|3008380|Other||Odds Ratio (OR)|-21.39||||0.054|2-Sided|95.0|-43.17|0.39|||Mixed Models Analysis||||
1637078|NCT01972789|3008381|Other||Odds Ratio (OR)|-0.31||||0.833|2-Sided|95.0|-3.2|2.58|||Mixed Models Analysis||||
1637107|NCT01972152|3008493|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Data were log transformed for analysis|||
1637083|NCT01972529|3008423|Superiority||Difference in change of platelet count|33.0|||<|0.0001|2-Sided|95.0|25.5|41.5|||Wilcoxon (Mann-Whitney)|P-value is based on Wilcoxon rank sum test for each avatrombopag treatment group vs placebo within each baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.||
1637084|NCT01972529|3008423|Superiority||Difference in change of platelet count|27.5|||<|0.0001|2-Sided|95.0|22.5|32.5|||Wilcoxon (Mann-Whitney)|P-value is based on Wilcoxon rank sum test for each avatrombopag treatment group vs placebo within each baseline platelet count cohort.|Difference in change from baseline of platelet count for avatrombopag vs placebo within each baseline platelet count cohort is based on Hodges-Lehmann estimation; 95% confidence interval is the asymptotic (Moses) CI.||
1637085|NCT01972529|3008424|Superiority||Difference of percentage vs placebo|67.5|||<|0.0001|2-Sided|95.0|51.6|83.4|||Cochran-Mantel-Haenszel|P-value is stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups|
1637086|NCT01972529|3008424|Superiority||Difference of proportion vs placebo|64.7|||<|0.0001|2-Sided|95.0|53.6|75.8|||Cochran-Mantel-Haenszel|P-value is stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of responders for avatrombopag – proportion of responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups|
1637087|NCT01972529|3008425|Superiority||Difference of proportion vs placebo|49.9|||<|0.0001|2-Sided|95.0|31.6|68.2|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion vs placebo = proportion of Responders for avatrombopag – proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the avatrombopag and placebo treatment groups.|
1637088|NCT01972529|3008425|Superiority||Difference of proportion vs placebo|42.6|||<|0.0001|2-Sided|95.0|27.2|58.1|||Cochran-Mantel-Haenszel|Stratified by the risk of bleeding associated with the elective procedure within each baseline platelet count cohort.|Difference of proportion versus (vs) placebo = proportion of Responders for avatrombopag – proportion of Responders for placebo; 95% CI is calculated based on normal approximation.|The null hypothesis was that the proportion of participants not requiring a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure was the same between the 60 mg avatrombopag and matched placebo treatment groups.|
1637089|NCT01972464|3008431|Superiority||Risk Ratio (RR)|0.91|||<|0.001|2-Sided|95.0|0.86|0.96|||general estimating equation|adjusted for age & pre-quit smoking level; specified a gamma distribution, log link, autoregressive correlation structure|risk ratio is progesterone versus placebo|null hypothesis rate of change in QSU-brief scores were equal between treatment groups|
1637090|NCT01972464|3008432|Superiority||Hazard Ratio (HR)|1.39||||0.41|2-Sided|95.0|0.66|3.38||a priori threshold = 0.05|Regression, Cox|Adjusted for age and pre-quit smoking level|Hazard ratio is placebo / progesterone||
1637091|NCT01972464|3008433|Superiority||Odds Ratio (OR)|1.77||||0.39|2-Sided|95.0|0.48|6.52||a priori threshold for statistical significance = 0.05|Regression, Logistic|adjusted for age (18-25 years versus >25 years) and pre-quit smoking level (<10 versus >10 cigarettes per day)|OR represents of odds of abstinence in progesterone group versus placebo group|Null hypothesis- odds of week 8 point prevalence abstinence were equal between placebo and progesterone group.|
1637092|NCT01972308|3008459|Superiority||Group differences in expected 12 month c|0.12|||||2-Sided|95.0|-0.24|0.6|||||||
1637093|NCT01972308|3008460|Superiority||Group differences in expected 12 month c|0.04|||||2-Sided|95.0|-0.1|0.19|||||||
1637094|NCT01972308|3008461|Superiority||Group differences in expected 12 month c|0.02|||||2-Sided|95.0|-0.42|0.48|||||||
1637095|NCT01972308|3008462|Superiority||Group differences in expected 12 month c|0.06|||||2-Sided|95.0|-0.33|0.43|||||||
1637096|NCT01972308|3008463|Superiority||Group differences in expected 12 month c|-0.66|||||2-Sided|95.0|-1.38|-0.01|||||||
1637097|NCT01972308|3008464|Superiority||Group differences in expected 12 month c|-0.31|||||2-Sided|95.0|-0.64|0.04|||||||
1637098|NCT01972217|3008468|Other||Hazard Ratio (HR)|0.788||||0.14|2-Sided|95.0|0.511|1.215||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank||||
1637099|NCT01972217|3008469|Other||Hazard Ratio (HR)|0.911||||0.331|2-Sided|95.0|0.6|1.384||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank||||
1637100|NCT01972217|3008470|Other||Hazard Ratio (HR)|0.809||||0.147|2-Sided|95.0|0.545|1.201||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||Olaparib + abiraterone versus placebo + abiraterone: TSST|
1637101|NCT01972217|3008470|Other||Hazard Ratio (HR)|0.781||||0.095|2-Sided|95.0|0.54|1.13||The p value was calculated with a 1-sided significance level of 2.5%.|Log Rank|||Olapatib + abiraterone versus placebo + abiraterone: TFST|
1637102|NCT01972217|3008471|Other||Odds Ratio (OR)|0.813||||0.309|2-Sided|95.0|0.285|2.261||The p value was calculated with a 1-sided significance level of 2.5%.|Regression, Logistic||||
1637103|NCT01972217|3008484|Superiority||Hazard Ratio (HR)|0.651||||0.017|2-Sided|95.0|0.438|0.969|||Log Rank|||The 1-sided p-value provides a test for rejecting the null hypothesis of no treatment effect versus the superiority alternative that patients on olaparib have a lower risk of progression compared with placebo.|
1637104|NCT01972152|3008492|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1637105|NCT01972152|3008492|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1637122|NCT01971723|3008510|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||This statistical analysis is for total squat volume measures, only.|
1637123|NCT01971723|3008510|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||This statistical analysis is for bench volume measure outcomes, only.|
1637124|NCT01971723|3008510|Superiority or Other||||||>|0.05|||||||ANOVA|||This statistical analysis is for squat volume measure outcomes, only.|
1637125|NCT01971723|3008510|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||This statistical analysis is for auxiliary squat volume measure outcomes, only.|
1637126|NCT01971723|3008510|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||This statistical analysis is for deadlift volume measure outcomes, only.|
1637127|NCT01971723|3008511|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1637128|NCT01971723|3008512|Superiority or Other||||||>|0.05|||||||ANOVA||||
1637129|NCT01971723|3008513|Superiority or Other||||||>|0.05|||||||ANOVA||||
1637130|NCT01971723|3008514|Superiority or Other||||||>|0.05|||||||ANOVA||||
1637131|NCT01971723|3008515|Superiority or Other||||||>|0.05|||||||ANOVA||||
1637132|NCT01971723|3008516|Superiority or Other||||||>|0.05|||||||ANOVA||||
1637133|NCT01971723|3008517|Superiority or Other||||||>|0.05|||||||ANOVA|||This statistical analysis for the triglyceride measure outcomes, only.|
1637134|NCT01971723|3008517|Superiority or Other||||||>|0.05|||||||ANOVA|||This statistical analysis is for LDL measure outcomes, only.|
1637135|NCT01971723|3008517|Superiority or Other||||||>|0.05|||||||ANOVA|||This statistical analysis is for HDL measure outcomes, only.|
1637136|NCT01971723|3008517|Superiority or Other||||||>|0.05|||||||ANOVA|||This statistical analysis is for glucose measure outcomes, only.|
1637137|NCT01971723|3008517|Superiority or Other||||||>|0.05|||||||ANOVA|||This statistical measurement is for cholesterol measure outcomes, only.|
1637138|NCT01971723|3008518|Superiority or Other||||||>|0.05|||||||ANOVA||||
1637139|NCT01971723|3008519|Superiority or Other|||||||0.0001|||||||ANOVA|||This statistical analysis compares the outcomes of the total weight lifted.|
1637140|NCT01971723|3008519|Superiority or Other|||||||0.3|||||||ANOVA|||This statistical analysis is for the deadlift one repetition maximum measures, only.|
1637141|NCT01971723|3008519|Superiority or Other|||||||0.0001|||||||ANOVA|||This statistical analysis is for the bench press one repetition maximum outcomes, only.|
1637142|NCT01971723|3008519|Superiority or Other|||||||0.38|||||||ANOVA|Groups were compared against each other at the two different time points and against themselves at the same time points.||This statistical analysis is for the squat one repetition maximum outcomes, only.|
1637143|NCT01971554|3008539|Superiority or Other||Difference in the least squares means|48.8|||||2-Sided|90.0|35.6|62.0|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.||
1637144|NCT01971554|3008539|Superiority or Other||Difference in the least squares means|30.6|||||2-Sided|90.0|17.4|43.8|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.||
1637145|NCT01971554|3008539|Superiority or Other||Difference in the least squares means|22.3|||||2-Sided|90.0|6.2|38.4|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.||
1637146|NCT01971554|3008545|Superiority or Other||Difference in the least squares means|54.1|||||2-Sided|90.0|38.1|70.0|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.||
1637147|NCT01971554|3008545|Superiority or Other||Difference in the least squares means|36.0|||||2-Sided|90.0|20.0|51.9|||||A cLDA model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.||
1637148|NCT01971554|3008545|Superiority or Other||Difference in the least squares means|30.8|||||2-Sided|90.0|11.3|50.3|||||A constrained longitudinal data analysis (cLDA) model was used to fit to the FPG data from the MK-8666 dose groups and placebo. Time was treated as a categorical variable so that no restriction was imposed on the trajectory of the means over time.||
1637149|NCT01971463|3008558|Superiority|Mixed effects regression, modeling the interaction term for time x normal saline bolus in the ipsilesional hemisphere|Slope|0.05|||<|0.001|2-Sided|95.0|0.03|0.07|||Mixed Models Analysis||||
1637150|NCT01971463|3008558|Superiority||||||<|0.05|||||||Wilcoxon signed rank|||Change in oCBF from baseline to post-bolus, ipsilesional hemisphere|
1637151|NCT01971346|3008563|Other|||||||0.34||||||Test of Hypotheses for Between subject effect of PASI profile p-value=0.34 Test of Hypotheses for Within subject effect of Time p-value=0.73 Test of Hypotheses for Within subject effect of Time*PASI profile p-value=0.57|ANOVA|||The strength of the IFN-alpha cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. Testing if IFN-alpha signals are significantly altered during the course of etanercept therapy and if such changes differ between subjects with different PASI response profiles.|
1637152|NCT01971346|3008564|Other|||||||0.03||||||Test of Hypotheses for Between subject effect of PASI profile p-value=0.03 Test of Hypotheses for Within subject effect of Time p-value=0.38 Test of Hypotheses for Within subject effect of Time*PASI profile p-value=0.31|ANOVA|||The strength of the TNF-alpha cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. Testing if TNF-alpha signals are significantly altered during the course of etanercept therapy and if such changes differ between subjects with different PASI response profiles.|
1637153|NCT01971346|3008565|Other|||||||0.38||||||Type III TNF-alpha p-value=0.36. Type III IFN-alpha p-value=0.36. Interaction was not included in this model.|Regression, Linear|||A cumulative score reflecting change in PASI during the course of treatment was calculated and treated as a continuous response variable. Linear modeling was done to determine if change in PASI score was associated with the baseline TNF-alpha signal, baseline IFN-alpha signal and/or an interaction between these two signals.|
1637154|NCT01970995|3008585|Superiority or Other (legacy)||Geometric LS Mean Ratio|23.25|||<|0.001|2-Sided|95.0|17.38|31.11||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on Total NNAL levels with product, sex, cigarette consumption, and baseline value as covariates|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 90 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 90 for mTHS 2.2 and mCC respectively."|
1637155|NCT01970995|3008586|Superiority or Other (legacy)||Geometric LS Mean Ratio|44.94|||<|0.001|2-Sided|95.0|42.11|47.97||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."|
1637156|NCT01970995|3008587|Superiority or Other (legacy)||Geometric LS Mean Ratio|10.97|||<|0.001|2-Sided|95.0|9.26|12.99||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."|
1637157|NCT01970995|3008588|Superiority or Other (legacy)||Geometric LS Mean Ratio|50.67|||<|0.001|2-Sided|95.0|44.88|57.2||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."|
1637158|NCT01970995|3008589|Superiority or Other (legacy)||Geometric LS Mean Ratio|13.49|||<|0.001|2-Sided|95.0|10.96|16.6||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|Geometric LS mean ratio mTHS 2.2:mCC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for mTHS 2.2 is lower relative to mCC.~Analysis of the biomarker of exposure (BoExp) was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for mTHS 2.2 and mCC respectively."|
1637159|NCT01970982|3008590|Superiority or Other (legacy)||Geometric LS Mean Ratio|47.1|||<|0.001|2-Sided|95.0|44.3|50.08||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."|
1637160|NCT01970982|3008591|Superiority or Other (legacy)||Geometric LS Mean Ratio|15.68|||<|0.001|2-Sided|95.0|13.09|18.78||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."|
1637161|NCT01970982|3008592|Superiority or Other (legacy)||Geometric LS Mean Ratio|52.86|||<|0.001|2-Sided|95.0|45.67|61.17||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."|
1637162|NCT01970982|3008593|Superiority or Other (legacy)||Geometric LS Mean Ratio|23.09|||<|0.001|2-Sided|95.0|18.41|28.95||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."|
1637163|NCT01970943|3008594|Other||Mean Difference (Final Values)|0.037786||||0.05|2-Sided||||||t-test, 2 sided||||
1637164|NCT01970943|3008596|Other||Mean Difference (Final Values)|0.6078||||0.05|2-Sided||||||t-test, 2 sided||||
1637165|NCT01970527|3008688|Superiority|||||||0.71|||||||Log Rank||||
1637166|NCT01970527|3008690|Superiority|||||||0.67|||||||Log Rank||||
1637167|NCT01970488|3008711|Non-Inferiority or Equivalence|Clinical equivalence was evaluated by comparing the 2-sided 95% confidence interval (CI) of the difference of PASI percent improvement from baseline to Week 16 between ABP 501 and adalimumab with an equivalence margin of ± 15.|Least Squares (LS) Mean Difference|-2.18|||||2-Sided|95.0|-7.39|3.02|||||||
1637168|NCT01970475|3008718|Non-Inferiority or Equivalence|The hypothesis was tested by comparing the 2-sided 90% confidence interval (CI) of the RR of ACR20 at week 24 between ABP 501 and adalimumab with an equivalence margin of (0.738, 1/0.738).|Risk Ratio (RR)|1.039|||||2-Sided|90.0|0.954|1.133|||||Based on a generalized linear model adjusted for geographic region and prior biological use for RA as covariates in the model.|The study hypothesis was that there were no clinically meaningful differences between ABP 501 and adalimumab in risk ratio (RR) of ACR20 at week 24.|
1637169|NCT01970371|3008731|Superiority|The two-sided 90% confidence interval for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|14.1|||||2-Sided|90.0|-13.0|40.3|||||||
1637170|NCT01970371|3008732|Superiority|The 2-sided 90% confidence interval (CI) for the unadjusted hazard ratio between groups in Cohort 1 (colistin:plazomicin) is based on a Cox proportional hazards regression model.|Hazard Ratio (HR)|3.97|||||2-Sided|90.0|1.08|14.61|||||||
1637171|NCT01970371|3008733|Superiority|The 2-sided 90% confidence interval (CI) for the difference in clinical cure percentage at the TOC visit between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|-0.3|||||2-Sided|90.0|-26.9|26.8|||||||
1637172|NCT01970371|3008734|Superiority|The 2-sided 90% confidence interval (CI) for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|28.2|||||2-Sided|90.0|0.7|52.5|||||||
1637173|NCT01970371|3008735|Superiority|The 2-sided 90% confidence interval (CI) for the difference between groups in Cohort 1 (colistin minus plazomicin) is based on the unconditional exact method.|Difference Estimate|26.5|||||2-Sided|90.0|-0.7|51.2|||||||
1637174|NCT01969747|3008768|Superiority or Other||Adjusted mean|104.81|Standard Error of the Mean|8.99|<|0.0001|2-Sided|95.0|86.88|122.74|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 25 mg with Placebo|
1637175|NCT01969747|3008768|Superiority or Other||Adjusted mean|106.39|Standard Error of the Mean|8.85|<|0.0001|2-Sided|95.0|88.73|124.05|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 10 mg with Placebo|
1637176|NCT01969747|3008768|Superiority or Other||Adjusted mean|76.09|Standard Error of the Mean|8.77|<|0.0001|2-Sided|95.0|58.6|93.59|||ANCOVA||The model includes baseline UGE as linear covariate(s) and treatment as fixed effect(s).|Comparison of Empagliflozin 2.5 mg with Placebo|
1637177|NCT01969721|3008769|Superiority or Other||Mean Difference (Net)|0.116|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.092|0.14||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 peak (0−3h) change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637178|NCT01969721|3008769|Superiority or Other||Mean Difference (Net)|0.111|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.087|0.135||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 peak (0−3h) change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637179|NCT01969721|3008769|Superiority or Other||Mean Difference (Net)|0.147|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.123|0.171||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 peak (0−3h) change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1638258|NCT01948310|3011459|Superiority||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks|
1637180|NCT01969721|3008769|Superiority or Other||Mean Difference (Net)|0.142|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.118|0.166||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 peak (0-3h) change from patient baseline (L)|Null hypothesis: Mean FEV1 peak (0-3h) change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 peak (0−3h) change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637181|NCT01969721|3008770|Superiority or Other||Mean Difference (Net)|0.032|Standard Error of the Mean|0.011||0.0055|2-Sided|95.0|0.009|0.054||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637182|NCT01969721|3008770|Superiority or Other||Mean Difference (Net)|0.028|Standard Error of the Mean|0.011||0.0146|2-Sided|95.0|0.006|0.051||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637183|NCT01969721|3008770|Superiority or Other||Mean Difference (Net)|0.043|Standard Error of the Mean|0.011||0.0002|2-Sided|95.0|0.021|0.065||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637184|NCT01969721|3008770|Superiority or Other||Mean Difference (Net)|0.039|Standard Error of the Mean|0.012||0.0007|2-Sided|95.0|0.017|0.062||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 12-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 12-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 12-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637185|NCT01969721|3008771|Superiority or Other||Mean Difference (Net)|0.054|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.029|0.078||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637186|NCT01969721|3008771|Superiority or Other||Mean Difference (Net)|0.042|Standard Error of the Mean|0.012|<|0.0007|2-Sided|95.0|0.018|0.067||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637187|NCT01969721|3008771|Superiority or Other||Mean Difference (Net)|0.058|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.034|0.082||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637188|NCT01969721|3008771|Superiority or Other||Mean Difference (Net)|0.047|Standard Error of the Mean|0.012|<|0.0002|2-Sided|95.0|0.022|0.071||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean trough FEV1 change from patient baseline (L)|Null hypothesis: Mean trough FEV1 change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean trough FEV1 change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637189|NCT01969721|3008772|Superiority or Other||Mean Difference (Net)|0.069|Standard Error of the Mean|0.011|<|0.0001|2-Sided|95.0|0.048|0.09||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 0−24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637190|NCT01969721|3008772|Superiority or Other||Mean Difference (Net)|0.065|Standard Error of the Mean|0.011|<|0.0001|2-Sided|95.0|0.045|0.086||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 2.5/5 μg) = Mean FEV1 AUC 0−24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637191|NCT01969721|3008772|Superiority or Other||Mean Difference (Net)|0.086|Standard Error of the Mean|0.011|<|0.0001|2-Sided|95.0|0.065|0.107||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 0−24h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637192|NCT01969721|3008772|Superiority or Other||Median Difference (Net)|0.082|Standard Error of the Mean|0.011|<|0.0001|2-Sided|95.0|0.061|0.103||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-24h change from patient baseline (L)|Null hypothesis: Mean FEV1 AUC 0-24h change from patient baseline (Tiotropium + Olodaterol 5/5 μg) = Mean FEV1 AUC 0-24h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 μg). Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect.|
1637193|NCT01969721|3008773|Superiority or Other||Mean Difference (Net)|0.106|Standard Error of the Mean|0.011|<|0.0001|2-Sided|95.0|0.085|0.128||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 2.5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."|
1637194|NCT01969721|3008773|Superiority or Other||Mean Difference (Net)|0.103|Standard Error of the Mean|0.011|<|0.0001||95.0|0.081|0.124||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 2.5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 2.5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."|
1637195|NCT01969721|3008773|Superiority or Other||Mean Difference (Net)|0.129|Standard Error of the Mean|0.011|<|0.0001|2-Sided|95.0|0.107|0.15||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 500/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 500/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."|
1638259|NCT01948141|3011469|Superiority or Other|||||||0.36|||||||Log Rank||||
1637196|NCT01969721|3008773|Superiority or Other||Mean Difference (Net)|0.125|Standard Error of the Mean|0.011|<|0.0001|2-Sided|95.0|0.103|0.147||p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is two-sided alpha=0.05.|Mixed Models Analysis|Compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.|Difference calculated as T+O 5/5 - F+S 250/50 adjusted mean FEV1 AUC 0-12h change from patient baseline (L)|"Null hypothesis: Mean FEV1 AUC 0-12h change from patient baseline (Tiotropium + Olodaterol 5/5 µg) = Mean FEV1 AUC 0-12h change from patient baseline (Fluticasone propionate + Salmeterol 250/50 µg).~Hypothesis was analysed using a restricted maximum likelihood-based mixed effect repeated measures model including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect."|
1637197|NCT01969500|3008788|Superiority||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|1.67||0.44|2-Sided|95.0|-4.66|2.06|||Linear mixed effects model||Mean difference (Intervention Arm - TAU) in change from baseline to 12 weeks||
1637198|NCT01969500|3008789|Superiority||Mean Difference (Final Values)|-0.71|Standard Error of the Mean|3.81||0.85|2-Sided|95.0|-8.37|6.96|||Linear mixed effects model||Mean difference (Intervention Arm - TAU) in change from baseline to 12 weeks||
1637199|NCT01969240|3008807|Superiority||Median Difference (Final Values)|1.7|||||2-Sided|95.0|-0.2|3.6|||||||
1637200|NCT01969240|3008808|Superiority||Mean Difference (Final Values)|-2.9|||||2-Sided|95.0|-4.8|-0.9|||||||
1637201|NCT01969240|3008809|Superiority||||||<|0.001|||||||negative binomial model||||
1637202|NCT01969240|3008810|Superiority|||||||0.998|||||||Regression, Logistic||||
1637203|NCT01969240|3008811|Superiority||Mean Difference (Final Values)|10.3|||||2-Sided|95.0|9.1|11.5|||||||
1637204|NCT01969240|3008812|Superiority||||||<|0.013|||||||t-test, 2 sided|The a-priori significance level was 0.05.|||
1637205|NCT01969240|3008813|Superiority||Mean Difference (Final Values)|0.66|||||2-Sided|95.0|0.46|0.86|||||||
1637206|NCT01969201|3008828|Other|||||||0.07|||||||Fisher Exact||||
1637207|NCT01969201|3008829|Other|||||||0.53|||||||Fisher Exact||||
1637208|NCT01969201|3008830|Other|||||||0.5|||||||Fisher Exact||||
1637209|NCT01969201|3008831|Other|||||||0.89|||||||ANOVA||||
1637210|NCT01969201|3008832|Other|||||||0.32|||||||ANOVA||||
1637211|NCT01969201|3008833|Other|||||||0.02|||||||ANOVA||||
1637212|NCT01969201|3008834|Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)||||
1637213|NCT01969201|3008835|Non-Inferiority|The non-inferiority was evaluated by calculating the 95% CI for the differences in pregnancy rates between the two treatment groups. If the lower bound of the 95% CI of the difference between the two proportions was greater than -0.10 (i.e. 10%), then Fostimon was to be considered not inferior to the control treatment.|Mean Difference (Final Values)|-2.73||||0.49|2-Sided|95.0|-9.88|4.42|||Fisher Exact||||
1637214|NCT01969084|3008841|Superiority or Other||||||>|0.05||||||A p-value of < 0.05 was considered statistically significant|Wilcoxon (Mann-Whitney)|||Data were expressed as the median (25th:75th percentiles) for non-normally distributed data. The mean±sd for the groups was not analyzed as per the statistical plan.|
1637215|NCT01969058|3008862|Superiority|||||||0.03||||||Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference between the two arms in the change in T-cell activation from baseline to week 14/16.|
1637216|NCT01968980|3008866|Superiority or Other||Odds Ratio (OR)|259.9|||||2-Sided|95.0|34.87|1937.06||||||Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.|
1637217|NCT01968980|3008866|Superiority or Other||Odds Ratio (OR)|228.0|||||2-Sided|95.0|51.95|1000.39||||||Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.|
1637218|NCT01968980|3008866|Superiority or Other||Odds Ratio (OR)|200.8|||||2-Sided|95.0|47.16|854.6||||||Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.|
1637219|NCT01968980|3008867|Superiority or Other||Odds Ratio (OR)|22.8|||||2-Sided|95.0|11.85|44.01||||||Week 52: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.|
1637220|NCT01968980|3008867|Superiority or Other||Odds Ratio (OR)|66.9|||||2-Sided|95.0|30.32|147.43||||||Week 24: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.|
1637221|NCT01968980|3008867|Superiority or Other||Odds Ratio (OR)|51.8|||||2-Sided|95.0|25.24|106.1||||||Week 12: Odds ratio, associated 95% confidence interval and p-value from a Logistic Regression Model with fixed effects for treatment group,baseline value and geographical region was used for analysis.|
1637222|NCT01968980|3008868|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.4|-0.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637223|NCT01968980|3008868|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.4|-0.4||||||Week 24:LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637224|NCT01968980|3008868|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.5|-0.4||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637401|NCT01967888|3009053|Superiority||least square mean difference|-22.9454|||=|0|2-Sided|95.0|-48.1826|2.2918|||Mixed Models Analysis||||
1637402|NCT01967888|3009054|Superiority||least square mean difference|-9.4641||||0.57|2-Sided|95.0|-42.49|23.5618|||Mixed Models Analysis||||
1637225|NCT01968980|3008869|Superiority or Other||LS Mean Difference|-1.6|Standard Error of the Mean|0.12|||2-Sided|95.0|-1.8|-1.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637226|NCT01968980|3008869|Superiority or Other||LS Mean Difference|-1.8|Standard Error of the Mean|0.13|||2-Sided|95.0|-2.1|-1.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637227|NCT01968980|3008869|Superiority or Other||LS Mean Difference|-2.0|Standard Error of the Mean|0.12|||2-Sided|95.0|-2.2|-1.8||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637228|NCT01968980|3008870|Superiority or Other||LS Mean Difference|3.5|Standard Error of the Mean|0.75|||2-Sided|95.0|2.0|4.9||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637229|NCT01968980|3008871|Superiority or Other||LS Mean Difference|-11.8|Standard Error of the Mean|1.47|||2-Sided|95.0|-14.7|-8.9||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637230|NCT01968980|3008872|Superiority or Other||LS Mean Difference|-53.8|Standard Error of the Mean|2.71|||2-Sided|95.0|-59.2|-48.5||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637231|NCT01968980|3008873|Superiority or Other||LS Mean Difference|-87.0|Standard Error of the Mean|4.25|||2-Sided|95.0|-95.4|-78.7||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637232|NCT01968980|3008874|Superiority or Other||LS Mean Difference|-83.2|Standard Error of the Mean|4.15|||2-Sided|95.0|-91.3|-75.0||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637233|NCT01968980|3008875|Superiority or Other||LS Mean Difference|-78.8|Standard Error of the Mean|3.75|||2-Sided|95.0|-86.2|-71.4||||||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637234|NCT01968980|3008876|Superiority or Other||LS Mean Difference|-9.5|Standard Error of the Mean|5.04|||2-Sided|95.0|-19.4|0.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637235|NCT01968980|3008876|Superiority or Other||LS Mean Difference|-17.4|Standard Error of the Mean|4.9|||2-Sided|95.0|-27.0|-7.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637236|NCT01968980|3008876|Superiority or Other||LS Mean Difference|-17.0|Standard Error of the Mean|4.22|||2-Sided|95.0|-25.3|-8.7||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637237|NCT01968980|3008877|Superiority or Other||LS Mean Difference|0.8|Standard Error of the Mean|1.39|||2-Sided|95.0|-1.9|3.6||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637238|NCT01968980|3008877|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|1.31|||2-Sided|95.0|-1.9|3.2||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637239|NCT01968980|3008877|Superiority or Other||LS Mean Difference|0.7|Standard Error of the Mean|1.5|||2-Sided|95.0|-2.3|3.6||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637240|NCT01968980|3008878|Superiority or Other||LS Mean Difference|3.0|Standard Error of the Mean|1.22|||2-Sided|95.0|0.5|5.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637241|NCT01968980|3008878|Superiority or Other||LS Mean Difference|4.6|Standard Error of the Mean|1.1|||2-Sided|95.0|2.5|6.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637242|NCT01968980|3008878|Superiority or Other||LS Mean Difference|5.3|Standard Error of the Mean|1.25|||2-Sided|95.0|2.9|7.8||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637403|NCT01967888|3009055|Superiority||least square mean difference|-0.025||||0.817|2-Sided|95.0|-0.0939|0.0689|||t-test, 2 sided||||
1637243|NCT01968980|3008879|Superiority or Other||LS Mean Difference|-9.5|Standard Error of the Mean|5.04|||2-Sided|95.0|-19.4|0.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637244|NCT01968980|3008879|Superiority or Other||LS Mean Difference|-17.4|Standard Error of the Mean|4.9|||2-Sided|95.0|-27.0|-7.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637245|NCT01968980|3008879|Superiority or Other||LS Mean Difference|-17.0|Standard Error of the Mean|4.22|||2-Sided|95.0|-25.3|-8.7||||||Week 12: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637246|NCT01968980|3008880|Superiority or Other||LS Mean Difference|2.9|Standard Error of the Mean|1.53|||2-Sided|95.0|-0.1|5.9||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637247|NCT01968980|3008880|Superiority or Other||LS Mean Difference|5.9|Standard Error of the Mean|1.42|||2-Sided|95.0|3.1|8.7||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637248|NCT01968980|3008881|Superiority or Other||LS Mean Difference|-15.3|Standard Error of the Mean|5.58|||2-Sided|95.0|-26.3|-4.4||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637249|NCT01968980|3008881|Superiority or Other||LS Mean Difference|-35.1|Standard Error of the Mean|12.58|||2-Sided|95.0|-59.8|-10.3||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637250|NCT01968980|3008882|Superiority or Other||LS Mean Difference|-40.5|Standard Error of the Mean|2.53|||2-Sided|95.0|-45.5|-35.5||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637251|NCT01968980|3008882|Superiority or Other||LS Mean Difference|-46.8|Standard Error of the Mean|2.67|||2-Sided|95.0|-52.1|-41.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637252|NCT01968980|3008883|Superiority or Other||LS Mean Difference|-42.2|Standard Error of the Mean|2.71|||2-Sided|95.0|-47.5|-36.9||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637253|NCT01968980|3008883|Superiority or Other||LS Mean Difference|-48.5|Standard Error of the Mean|2.86|||2-Sided|95.0|-54.1|-42.8||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637254|NCT01968980|3008884|Superiority or Other||LS Mean Difference|-31.8|Standard Error of the Mean|2.02|||2-Sided|95.0|-35.8|-27.8||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637255|NCT01968980|3008884|Superiority or Other||LS Mean Difference|-35.8|Standard Error of the Mean|2.12|||2-Sided|95.0|-40.0|-31.6||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637256|NCT01968980|3008885|Superiority or Other||LS mean difference|-48.0|Standard Error of the Mean|2.87|||2-Sided|95.0|-53.6|-42.3||||||Week 52: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637257|NCT01968980|3008885|Superiority or Other||LS mean difference|-52.1|Standard Error of the Mean|3.1|||2-Sided|95.0|-58.2|-46.0||||||Week 24: LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637258|NCT01968980|3008886|Superiority or Other||LS mean difference|7.0|Standard Error of the Mean|1.47|<|0.001|2-Sided|95.0|4.1|9.9|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637259|NCT01968980|3008887|Superiority or Other||LS mean difference|-28.6|Standard Error of the Mean|2.73|<|0.001|2-Sided|95.0|-33.9|-23.2|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637260|NCT01968980|3008888|Superiority or Other||LS mean difference|-48.0|Standard Error of the Mean|2.44|<|0.001|2-Sided|95.0|-52.8|-43.2|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637261|NCT01968980|3008889|Superiority or Other||LS mean difference|-51.0|Standard Error of the Mean|2.36|<|0.001|2-Sided|95.0|-55.7|-46.4|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637262|NCT01968980|3008890|Superiority or Other||LS mean difference|-37.6|Standard Error of the Mean|1.77|<|0.001|2-Sided|95.0|-41.1|-34.1|||MMRM|||LS-mean difference,associated 95% confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637263|NCT01968980|3008891|Superiority or Other||Least square (LS) mean difference|-54.5|Standard Error of the Mean|2.54|<|0.001|2-Sided|95.0|-59.5|-49.5|||Mixed Model Repeated Measures (MMRM)|||LS-mean difference,associated 95 percent (%) confidence intervals (CI), and p-values were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region.|
1637264|NCT01968967|3008898|Superiority or Other||Odds Ratio (OR)|25.5|||||2-Sided|95.0|18.9|34.47||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.|
1637265|NCT01968967|3008898|Superiority or Other||Odds Ratio (OR)|35.9|||||2-Sided|95.0|26.83|47.96||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.|
1637266|NCT01968967|3008898|Superiority or Other||Odds Ratio (OR)|86.5|||||2-Sided|95.0|61.74|121.25||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.|
1637267|NCT01968967|3008899|Superiority or Other||Odds Ratio (OR)|6.3|||||2-Sided|95.0|4.99|8.06||||||Week 52: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.|
1637268|NCT01968967|3008899|Superiority or Other||Odds Ratio (OR)|12.9|||||2-Sided|95.0|9.84|16.86||||||Week 24: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.|
1637269|NCT01968967|3008899|Superiority or Other||Odds Ratio (OR)|27.0|||||2-Sided|95.0|19.21|38.02||||||Week 12: Odds ratio, associated 95% CI were derived from a logistic regression model with fixed effects for treatment group, baseline value, geographical region and triglyceride subgroup.|
1637270|NCT01968967|3008900|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.01|||2-Sided|95.0|-0.3|-0.2||||||Week 52: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637271|NCT01968967|3008900|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.01|||2-Sided|95.0|-0.3|-0.3||||||Week 24: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637272|NCT01968967|3008900|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.01|||2-Sided|95.0|-0.3|-0.3||||||Week 12: LS mean difference and associated 95% confidence interval CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637273|NCT01968967|3008901|Superiority or Other||LS Mean Difference|-1.1|Standard Error of the Mean|0.05|||2-Sided|95.0|-1.2|-1.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637274|NCT01968967|3008901|Superiority or Other||LS Mean Difference|-1.4|Standard Error of the Mean|0.05|||2-Sided|95.0|-1.5|-1.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637275|NCT01968967|3008901|Superiority or Other||LS Mean Difference|-1.6|Standard Error of the Mean|0.04|||2-Sided|95.0|-1.6|-1.5||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637276|NCT01968967|3008902|Superiority or Other||LS Mean Difference|2.7|Standard Error of the Mean|0.31|||2-Sided|95.0|2.1|3.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637277|NCT01968967|3008903|Superiority or Other||LS Mean Difference|-10.6|Standard Error of the Mean|0.63|||2-Sided|95.0|-11.8|-9.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637278|NCT01968967|3008904|Superiority or Other||LS Mean Difference|-45.8|Standard Error of the Mean|0.97|||2-Sided|95.0|-47.7|-43.9||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637404|NCT01967888|3009056|Superiority||least square mean difference|0.0136||||0.846|2-Sided|95.0|-0.0508|0.0781|||t-test, 2 sided||||
1637405|NCT01967888|3009057|Superiority||least square mean difference|-0.1178242||||0.161|2-Sided|95.0|-0.287431|0.0517825|||t-test, 2 sided||||
1637279|NCT01968967|3008905|Superiority or Other||LS Mean Difference|-66.4|Standard Error of the Mean|1.46|||2-Sided|95.0|-69.3|-63.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637280|NCT01968967|3008906|Superiority or Other||LS Mean Difference|-63.7|Standard Error of the Mean|1.46|||2-Sided|95.0|-66.6|-60.9||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637281|NCT01968967|3008907|Superiority or Other||LS Mean Difference|-61.0|Standard Error of the Mean|1.27|||2-Sided|95.0|-63.5|-58.5||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637282|NCT01968967|3008908|Superiority or Other||LS Mean Difference|-62.8|Standard Error of the Mean|2.8|||2-Sided|95.0|-68.3|-57.3||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1637283|NCT01968967|3008909|Superiority or Other||LS Mean Difference|-60.4|Standard Error of the Mean|1.4|||2-Sided|95.0|-63.1|-57.6||||||LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1637284|NCT01968967|3008910|Superiority or Other||LS Mean Difference|-12.8|Standard Error of the Mean|1.91|||2-Sided|95.0|-16.5|-9.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637285|NCT01968967|3008910|Superiority or Other||LS Mean Difference|-16.7|Standard Error of the Mean|2.05|||2-Sided|95.0|-20.7|-12.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637286|NCT01968967|3008910|Superiority or Other||LS Mean Difference|-16.6|Standard Error of the Mean|1.73|||2-Sided|95.0|-20.0|-13.2||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637287|NCT01968967|3008911|Superiority or Other||LS Mean Difference|1.5|Standard Error of the Mean|0.61|||2-Sided|95.0|0.3|2.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637288|NCT01968967|3008911|Superiority or Other||LS Mean Difference|1.1|Standard Error of the Mean|0.61|||2-Sided|95.0|-0.1|2.3||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637289|NCT01968967|3008911|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.59|||2-Sided|95.0|-0.9|1.4||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637290|NCT01968967|3008912|Superiority or Other||LS Mean Difference|3.8|Standard Error of the Mean|0.57|||2-Sided|95.0|2.7|4.9||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637291|NCT01968967|3008912|Superiority or Other||LS Mean Difference|3.5|Standard Error of the Mean|0.51|||2-Sided|95.0|2.5|4.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637292|NCT01968967|3008912|Superiority or Other||LS Mean Difference|3.4|Standard Error of the Mean|0.49|||2-Sided|95.0|2.4|4.3||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637293|NCT01968967|3008913|Superiority or Other||LS Mean Difference|-12.8|Standard Error of the Mean|1.91|||2-Sided|95.0|-16.5|-9.0||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637294|NCT01968967|3008913|Superiority or Other||LS Mean Difference|-16.7|Standard Error of the Mean|2.05|||2-Sided|95.0|-20.7|-12.6||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637332|NCT01968954|3008933|Superiority or Other||LS mean difference|2.4|Standard Error of the Mean|0.55|||2-Sided|95.0|1.4|3.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637295|NCT01968967|3008913|Superiority or Other||LS Mean Difference|-16.6|Standard Error of the Mean|1.73|||2-Sided|95.0|-20.0|-13.2||||||Week 12: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637296|NCT01968967|3008914|Superiority or Other||LS Mean Difference|-40.7|Standard Error of the Mean|1.46|||2-Sided|95.0|-43.5|-37.8||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637297|NCT01968967|3008914|Superiority or Other||LS Mean Difference|-50.7|Standard Error of the Mean|1.34|||2-Sided|95.0|-53.3|-48.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637298|NCT01968967|3008915|Superiority or Other||LS Mean Difference|5.2|Standard Error of the Mean|0.76|||2-Sided|95.0|3.7|6.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637299|NCT01968967|3008915|Superiority or Other||LS Mean Difference|5.5|Standard Error of the Mean|0.67|||2-Sided|95.0|4.2|6.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637300|NCT01968967|3008915|Superiority or Other||LS Mean Difference|5.8|Standard Error of the Mean|0.63|<|0.001|2-Sided|95.0|4.5|7.0|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637301|NCT01968967|3008916|Superiority or Other||LS Mean Difference|-25.3|Standard Error of the Mean|5.89|||2-Sided|95.0|-36.8|-13.7||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637302|NCT01968967|3008916|Superiority or Other||LS Mean Difference|-31.1|Standard Error of the Mean|4.86|||2-Sided|95.0|-40.6|-21.5||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637303|NCT01968967|3008916|Superiority or Other||LS Mean Difference|-28.5|Standard Error of the Mean|3.04|<|0.001|2-Sided|95.0|-34.4|-22.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637304|NCT01968967|3008917|Superiority or Other||LS Mean Difference|-34.6|Standard Error of the Mean|2.83|||2-Sided|95.0|-40.2|-29.0||||||Week 52: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1637305|NCT01968967|3008917|Superiority or Other||LS Mean Difference|-44.0|Standard Error of the Mean|2.61|||2-Sided|95.0|-49.1|-38.8||||||Week 24: LS mean difference and associated 95% CI were derived from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1637306|NCT01968967|3008917|Superiority or Other||LS Mean Difference|-51.8|Standard Error of the Mean|2.09|<|0.001|2-Sided|95.0|-55.9|-47.7|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1637307|NCT01968967|3008918|Superiority or Other||LS Mean Difference|-42.8|Standard Error of the Mean|1.7|||2-Sided|95.0|-46.2|-39.5||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1637308|NCT01968967|3008918|Superiority or Other||LS Mean Difference|-53.1|Standard Error of the Mean|1.55|||2-Sided|95.0|-56.1|-50.0||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1637309|NCT01968967|3008918|Superiority or Other||LS Mean Difference|-57.7|Standard Error of the Mean|1.29|<|0.001|2-Sided|95.0|-60.2|-55.2|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction and geographical region. An unstructured variance covariance matrix was used.|
1637310|NCT01968967|3008919|Superiority or Other||LS Mean Difference|-35.9|Standard Error of the Mean|1.33|||2-Sided|95.0|-38.5|-33.3||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637397|NCT01967888|3009049|Superiority||least square mean difference|1.07617|||=|0|2-Sided|95.0|-6.76562|8.91796|||Mixed Models Analysis||||
1637398|NCT01967888|3009050|Superiority||least square mean difference|0.09716|||=|0|2-Sided|95.0|-7.41834|7.61266|||Mixed Models Analysis||||
1637311|NCT01968967|3008919|Superiority or Other||LS Mean Difference|-45.5|Standard Error of the Mean|1.22|||2-Sided|95.0|-47.9|-43.1||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637312|NCT01968967|3008919|Superiority or Other||LS Mean Difference|-50.1|Standard Error of the Mean|1.04|<|0.001|2-Sided|95.0|-52.1|-48.0|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637313|NCT01968967|3008920|Superiority or Other||LS Mean Difference|-36.1|Standard Error of the Mean|1.28|||2-Sided|95.0|-38.6|-33.6||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637314|NCT01968967|3008920|Superiority or Other||LS Mean Difference|-46.1|Standard Error of the Mean|1.19|||2-Sided|95.0|-48.5|-43.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637315|NCT01968967|3008920|Superiority or Other||LS Mean Difference|-50.8|Standard Error of the Mean|1.04|<|0.001|2-Sided|95.0|-52.9|-48.8|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637316|NCT01968967|3008921|Superiority or Other||LS Mean Difference|-24.7|Standard Error of the Mean|0.96|||2-Sided|95.0|-26.6|-22.8||||||Week 52: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637317|NCT01968967|3008921|Superiority or Other||LS Mean Difference|-31.6|Standard Error of the Mean|0.89|||2-Sided|95.0|-33.3|-29.8||||||Week 24: LS mean difference and associated 95% CI were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637318|NCT01968967|3008921|Superiority or Other||LS Mean Difference|-35.0|Standard Error of the Mean|0.76|<|0.001|2-Sided|95.0|-36.5|-33.5|||MMRM|||Week 12: LS mean difference and associated 95% CI and p-value were derived from MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637319|NCT01968967|3008922|Superiority or Other||LS Mean Difference|-56.2|Standard Error of the Mean|1.1|<|0.001|2-Sided|95.0|-58.3|-54.0|||MMRM|||Least square (LS) mean difference and associated 95 percent (%) confidence interval (CI), and p-value were derived from mixed effect model repeat measurement (MMRM) model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region and triglyceride subgroup. An unstructured variance covariance matrix was used.|
1637320|NCT01968954|3008929|Superiority or Other||Odds Ratio (OR)|29.1|||||2-Sided|95.0|17.13|49.49||||||Week 52|
1637321|NCT01968954|3008929|Superiority or Other||Odds Ratio (OR)|112.2|||||2-Sided|95.0|55.81|225.52||||||Week 24|
1637322|NCT01968954|3008929|Superiority or Other||Odds Ratio (OR)|95.2|||||2-Sided|95.0|52.09|173.91||||||Week 12|
1637323|NCT01968954|3008930|Superiority or Other||Odds Ratio (OR)|9.8|||||2-Sided|95.0|6.36|15.24||||||Week 52|
1637324|NCT01968954|3008930|Superiority or Other||Odds Ratio (OR)|14.8|||||2-Sided|95.0|9.32|23.56||||||Week 24|
1637325|NCT01968954|3008930|Superiority or Other||Odds Ratio (OR)|24.0|||||2-Sided|95.0|13.86|41.64||||||Week 12|
1637326|NCT01968954|3008931|Superiority or Other||LS mean difference|-0.3|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.3|-0.2||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637327|NCT01968954|3008931|Superiority or Other||LS mean difference|-0.3|Standard Error of the Mean|0.01|||2-Sided|95.0|-0.4|-0.3||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637328|NCT01968954|3008931|Superiority or Other||LS mean difference|-0.3|Standard Error of the Mean|0.01|||2-Sided|95.0|-0.4|-0.3||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637329|NCT01968954|3008932|Superiority or Other||LS mean difference|-1.2|Standard Error of the Mean|0.08|||2-Sided|95.0|-1.4|-1.0||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637330|NCT01968954|3008932|Superiority or Other||LS mean difference|-1.5|Standard Error of the Mean|0.08|||2-Sided|95.0|-1.7|-1.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637331|NCT01968954|3008932|Superiority or Other||LS mean difference|-1.6|Standard Error of the Mean|0.06|||2-Sided|95.0|-1.7|-1.4||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637399|NCT01967888|3009051|Superiority||least square mean difference|-0.277|||=|0|2-Sided|95.0|-0.7936|0.2396|||Mixed Models Analysis||||
1637333|NCT01968954|3008934|Superiority or Other||LS mean difference|-10.6|Standard Error of the Mean|1.17|||2-Sided|95.0|-12.9|-8.3||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637334|NCT01968954|3008935|Superiority or Other||LS mean difference|-47.3|Standard Error of the Mean|1.74|||2-Sided|95.0|-50.7|-43.8||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637335|NCT01968954|3008936|Superiority or Other||LS mean difference|-69.7|Standard Error of the Mean|2.57|||2-Sided|95.0|-74.7|-64.6||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637336|NCT01968954|3008937|Superiority or Other||LS mean difference|-67.1|Standard Error of the Mean|2.59|||2-Sided|95.0|-72.2|-62.1||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637337|NCT01968954|3008938|Superiority or Other||LS mean difference|-63.4|Standard Error of the Mean|2.35|||2-Sided|95.0|-68.0|-58.8||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637338|NCT01968954|3008939|Superiority or Other||LS mean difference|-59.6|Standard Error of the Mean|5.99|||2-Sided|95.0|-71.4|-47.7||||||TG >=200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.|
1637339|NCT01968954|3008939|Superiority or Other||LS mean difference|-64.2|Standard Error of the Mean|2.51|||2-Sided|95.0|-69.1|-59.2||||||TG <200 mg/dL (Week 12): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.|
1637340|NCT01968954|3008940|Superiority or Other||LS mean difference|-9.2|Standard Error of the Mean|3.31|||2-Sided|95.0|-15.7|-2.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637341|NCT01968954|3008940|Superiority or Other||LS mean difference|-19.9|Standard Error of the Mean|2.65|||2-Sided|95.0|-25.1|-14.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637342|NCT01968954|3008940|Superiority or Other||LS-Mean Difference|-14.2|Standard Error of the Mean|2.88|||2-Sided|95.0|-19.9|-8.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637343|NCT01968954|3008941|Superiority or Other||LS mean difference|1.0|Standard Error of the Mean|1.03|||2-Sided|95.0|-1.0|3.1||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637344|NCT01968954|3008941|Superiority or Other||LS mean difference|1.9|Standard Error of the Mean|1.02|||2-Sided|95.0|-0.1|3.9||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637345|NCT01968954|3008941|Superiority or Other||LS mean difference|-0.1|Standard Error of the Mean|0.93|||2-Sided|95.0|-1.9|1.7||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637346|NCT01968954|3008942|Superiority or Other||LS mean difference|2.6|Standard Error of the Mean|0.98|||2-Sided|95.0|0.7|4.6||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637347|NCT01968954|3008942|Superiority or Other||LS mean difference|4.9|Standard Error of the Mean|0.91|||2-Sided|95.0|3.1|6.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637348|NCT01968954|3008942|Superiority or Other||LS mean difference|3.7|Standard Error of the Mean|1.0|||2-Sided|95.0|1.8|5.7||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637349|NCT01968954|3008943|Superiority or Other||LS mean difference|-9.2|Standard Error of the Mean|3.31|||2-Sided|95.0|-15.7|-2.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637350|NCT01968954|3008943|Superiority or Other||LS mean difference|-19.9|Standard Error of the Mean|2.65|||2-Sided|95.0|-25.1|-14.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637351|NCT01968954|3008943|Superiority or Other||LS mean difference|-14.2|Standard Error of the Mean|2.88|||2-Sided|95.0|-19.9|-8.5||||||Week 12: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637400|NCT01967888|3009052|Superiority||least square mean difference|-0.2074|||=|0|2-Sided|95.0|-0.6538|0.2389|||Mixed Models Analysis||||
1637352|NCT01968954|3008944|Superiority or Other||LS mean difference|-41.2|Standard Error of the Mean|5.6|||2-Sided|95.0|-52.2|-30.1||||||TG >=200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.|
1637353|NCT01968954|3008944|Superiority or Other||LS mean difference|-49.3|Standard Error of the Mean|4.83|||2-Sided|95.0|-58.9|-39.8||||||TG >=200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.|
1637354|NCT01968954|3008944|Superiority or Other||LS mean difference|-47.7|Standard Error of the Mean|3.16|||2-Sided|95.0|-53.9|-41.5||||||TG <200 mg/dL (Week 52): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.|
1637355|NCT01968954|3008944|Superiority or Other||LS mean difference|-57.6|Standard Error of the Mean|2.82|||2-Sided|95.0|-63.1|-52.0||||||TG <200 mg/dL (Week 24): LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region.|
1637356|NCT01968954|3008945|Superiority or Other||LS mean difference|-46.4|Standard Error of the Mean|2.77|||2-Sided|95.0|-51.8|-41.0||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637357|NCT01968954|3008945|Superiority or Other||LS mean difference|-56.0|Standard Error of the Mean|2.45|||2-Sided|95.0|-60.8|-51.2||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637358|NCT01968954|3008946|Superiority or Other||LS mean difference|-48.7|Standard Error of the Mean|4.72|<|0.001|2-Sided|95.0|-58.0|-39.3|||MMRM|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637359|NCT01968954|3008947|Superiority or Other||LS mean difference|-59.1|Standard Error of the Mean|2.19|<|0.001|2-Sided|95.0|-63.4|-54.8|||MMRM|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637360|NCT01968954|3008948|Superiority or Other||LS mean difference|3.3|Standard Error of the Mean|1.25|||2-Sided|95.0|0.9|5.8||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637361|NCT01968954|3008948|Superiority or Other||LS mean difference|6.8|Standard Error of the Mean|1.18|||2-Sided|95.0|4.5|9.1||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637362|NCT01968954|3008948|Superiority or Other||LS mean difference|4.7|Standard Error of the Mean|1.19|<|0.001|2-Sided|95.0|2.4|7.0|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637363|NCT01968954|3008949|Superiority or Other||LS mean difference|12.9|Standard Error of the Mean|29.25|||2-Sided|95.0|-44.5|70.4||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637364|NCT01968954|3008949|Superiority or Other||LS mean difference|2.1|Standard Error of the Mean|25.11|||2-Sided|95.0|-47.2|51.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637365|NCT01968954|3008949|Superiority or Other||LS mean difference|-2.9|Standard Error of the Mean|16.55||0.86|2-Sided|95.0|-35.4|29.5|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637366|NCT01968954|3008950|Superiority or Other||LS mean difference|-40.8|Standard Error of the Mean|2.26|||2-Sided|95.0|-45.2|-36.3||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637367|NCT01968954|3008950|Superiority or Other||LS mean difference|-50.6|Standard Error of the Mean|2.05|||2-Sided|95.0|-54.6|-46.6||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637368|NCT01968954|3008950|Superiority or Other||LS mean difference|-51.5|Standard Error of the Mean|1.84|<|0.001|2-Sided|95.0|-55.1|-47.9|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637369|NCT01968954|3008951|Superiority or Other||LS mean difference|-41.2|Standard Error of the Mean|2.38|||2-Sided|95.0|-45.8|-36.5||||||Week 52:LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637370|NCT01968954|3008951|Superiority or Other||LS mean Difference|-50.6|Standard Error of the Mean|2.15|||2-Sided|95.0|-54.9|-46.4||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637371|NCT01968954|3008951|Superiority or Other||LS mean difference|-51.6|Standard Error of the Mean|1.8|<|0.001|2-Sided|95.0|-55.2|-48.1|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637372|NCT01968954|3008952|Superiority or Other||LS mean difference|-29.0|Standard Error of the Mean|1.69|||2-Sided|95.0|-32.3|-25.7||||||Week 52: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637373|NCT01968954|3008952|Superiority or Other||LS mean difference|-34.7|Standard Error of the Mean|1.52|||2-Sided|95.0|-37.7|-31.7||||||Week 24: LS-mean difference, associated 95% confidence intervals with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637374|NCT01968954|3008952|Superiority or Other||LS mean difference|-36.2|Standard Error of the Mean|1.33|<|0.001|2-Sided|95.0|-38.8|-33.6|||MMRM|||Week 12: LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637375|NCT01968954|3008953|Superiority or Other||Least Square (LS) Mean Difference|-57.0|Standard Error of the Mean|2.0|<|0.001|2-Sided|95.0|-61.0|-53.1|||Mixed Model Repeated Measures (MMRM)|||LS-mean difference, associated 95% confidence intervals and p values from an MMRM model with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographical region, triglyceride subgroup.|
1637376|NCT01968551|3008962|Non-Inferiority or Equivalence|Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48.|Difference in proportion|18.3||||0.004|2-Sided|95.001|3.5|33.0|||Fisher Exact||Difference in percentages of virologic success and its 95.001% CI were calculated based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.||
1637377|NCT01968551|3008963|Non-Inferiority or Equivalence|Null Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV was at least 12% lower than the group remaining on SBR with respect to percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24. Alternative Hypothesis: In Cohort 2, the group switching to E/C/F/TAF + DRV is less than 12% lower than the group remaining on SBR with respect to the proportion of participants with HIV-1 RNA<50 copies/mL at Week 24.|Difference in proportion|5.3||||0.23|2-Sided|95.001|-3.4|17.4|||Fisher Exact||Difference in percentages of virologic success and its 95.001% confidence interval (CI) calculation was based on exact method. The exact CI was estimated based on unconditional exact method using 2 inverted 1-sided tests with standardized statistic.||
1637378|NCT01968447|3008970|Superiority or Other (legacy)|||||||0.59|||||||Mixed Models Analysis||||
1637379|NCT01968434|3008971|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1637380|NCT01968434|3008972|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1637381|NCT01968434|3008973|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|||The sample size was calculated to detect a 0.75 point difference between any two treatment groups with a 90% power and p<0.05. Such sample size was 60 subject which was elevated ot 75 subjects per group to account for drop outs. For comparison of cough evaluation before and after treatment a paired Student t test was used.|
1637382|NCT01968382|3008982|Superiority|||||||0.8462|||||||ANOVA||||
1637383|NCT01968382|3008985|Superiority|||||||0.3198|||||||ANOVA||||
1637384|NCT01968213|3008996|Superiority||Cox Proportional Hazard|0.354|||<|0.0001|2-Sided|95.0|0.278|0.45|||Regression, Cox||||Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.
1637385|NCT01968213|3008997|Superiority||Cox Proportional Hazard|0.365|||<|0.0001|2-Sided|95.0|0.295|0.451|||Regression, Cox||||Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.
1637386|NCT01967940|3009027|Superiority|Enrollment into this study was stopped early due to the challenge of recruiting a sufficient number of participants who met the eligibility criteria. The actual number of enrolled is 55, among them 43 enrolled in the Randomized Cohort. Based on the actual enrollment numbers, the power to detect a 35% difference drops to 51%, under the same assumptions in the original sample size calculations.|Difference in proportions|60.7|||<|0.001|2-Sided|95.0|42.6|78.8|||Fisher Exact||The 95% confidence interval was estimated based on unconditional exact method using 2 inverted 1-sided tests with the standardized statistic.|A sample size of 90 participants, randomized in a 2:1 ratio, achieves 89% power to detect a 35% difference in the proportion of participants with HIV-1 RNA decreases from baseline exceeding 0.5 log10 between the TAF and placebo arms at Day 10. Sample size and power computation was based on the assumption that 50% of participants in the TAF arm and 15% of participants in the placebo arm achieved a reduction exceeding 0.5 log10 HIV-1 RNA.|
1637387|NCT01967888|3009030|Superiority||Least square mean difference|23.5454|||=|0|2-Sided|95.0|-38.6619|85.7528|||Mixed Models Analysis||||
1637388|NCT01967888|3009031|Superiority||least square mean difference|31.3491|||=|0|2-Sided|95.0|-60.998|123.7|||Mixed Models Analysis||||
1637389|NCT01967888|3009036|Superiority|||||||1|||||||Wilcoxon rank-sum test||||
1637390|NCT01967888|3009037|Superiority|||||||0.91|||||||Wilcoxon rank-sum test||||
1637391|NCT01967888|3009038|Superiority|||||||0.448|||||||Wilcoxon rank-sum test||||
1637392|NCT01967888|3009044|Superiority||Treatment effect|5.0||||0.64|2-Sided|95.0|-15.91|25.93|||Chi-squared||||
1637393|NCT01967888|3009045|Superiority||Hazard Ratio (HR)|3.21||||0.339|2-Sided|95.0|0.29|34.97|||Anderson-Gill model||||
1637394|NCT01967888|3009046|Superiority||Treatment effect|2.1||||0.842|2-Sided|95.0|-18.2|22.33|||Chi-squared||||
1637395|NCT01967888|3009047|Superiority|||||||0.403|||||||Wilcoxon (Mann-Whitney)||||
1637396|NCT01967888|3009048|Superiority|||||||0.176|||||||Wilcoxon (Mann-Whitney)||||
1637406|NCT01967888|3009058|Superiority||least square mean difference|-0.1601778||||0.092|2-Sided|95.0|-0.317803|-0.0025525|||t-test, 2 sided||||
1637407|NCT01967888|3009059|Superiority||t-test|-1.2||||0.542|2-Sided|95.0|-14.3|0.0|||Cochran-Mantel-Haenszel||||
1637408|NCT01967732|3009068|Superiority or Other (legacy)||Geometric LS Mean Ratio|74.47|||||2-Sided|95.0|61.52|90.14|||||LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.|
1637409|NCT01967732|3009069|Superiority or Other (legacy)||Geometric LS Mean Ratio|77.43|||||2-Sided|95.0|62.69|95.63|||||LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.|
1637410|NCT01967719|3009070|Superiority or Other (legacy)||Geometric LS Mean Ratio|55.64|||||2-Sided|95.0|43.3|71.5|||||LS mean ratio (mTHS 2.2 - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS 2.2:mCC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.|
1637411|NCT01967719|3009071|Superiority or Other (legacy)||Geometric LS Mean Ratio|56.57|||||2-Sided|95.0|44.21|72.39|||||LS mean ratio (mTHS 2.2 - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS 2.2:mCC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.|
1637412|NCT01967706|3009072|Other||Geometric LS Mean Ratio|98.13|||||2-Sided|95.0|80.61|119.46|||||LS mean ratio (mTHS - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.|
1637413|NCT01967706|3009073|Other||Geometric LS Mean Ratio|88.47|||||2-Sided|95.0|68.64|114.03|||||LS mean ratio (mTHS - Group 1:mCC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of mTHS:mCC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.|
1637414|NCT01967537|3009081|Superiority|||||||0.23|||||||Mann-Whitney||||
1637415|NCT01967342|3009092|Superiority or Other||Odds Ratio (OR)|0.72||||0.389|2-Sided||||||Mixed Models Analysis||CBT vs. EDU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).|
1637416|NCT01967342|3009092|Superiority or Other||Odds Ratio (OR)|5.32||||0.001|2-Sided||||||Mixed Models Analysis||EDU vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).|
1637417|NCT01967342|3009092|Superiority or Other||Odds Ratio (OR)|3.81||||0.009|2-Sided||||||Mixed Models Analysis||CBT vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at follow-up (6-months).|
1637418|NCT01967342|3009092|Superiority or Other||Odds Ratio (OR)|1.53||||0.217|2-Sided||||||Mixed Models Analysis||CBT vs. EDU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at pre-treatment (10-weeks).|
1637419|NCT01967342|3009092|Superiority or Other||Odds Ratio (OR)|5.53||||0.001|2-Sided||||||Mixed Models Analysis||EDU vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (10-weeks).|
1637420|NCT01967342|3009092|Superiority or Other||Odds Ratio (OR)|8.45|||<|0.001|2-Sided||||||Mixed Models Analysis||CBT vs. TAU|Odds ratios were computed to describe the likelihood of participants in each treatment condition reporting clinically meaningful improvement on the PGIC-pain intensity relative to the other groups at post-treatment (6-months).|
1637421|NCT01967342|3009093|Superiority or Other||Mean Difference (Net)|0.434|Standard Error of the Mean|0.541||0.422|2-Sided|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the post-treatment and 6-month follow-up.|
1637422|NCT01967342|3009093|Superiority or Other||Mean Difference (Net)|-2.251|Standard Error of the Mean|0.617|<|0.001|2-Sided|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Pain Ed group between the pre-treatment and 10-week post-treatment.|
1637423|NCT01967342|3009093|Superiority or Other||Mean Difference (Net)|0.619|Standard Error of the Mean|0.528|<|0.241|2-Sided|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the post-treatment and 6-month follow-up.|
1637424|NCT01967342|3009093|Superiority or Other||Mean Difference (Net)|-2.416|Standard Error of the Mean|0.612|<|0.001|2-Sided|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within CBT for Pain group between the pre-treatment and 10-week post-treatment.|
1637425|NCT01967342|3009093|Superiority or Other||Mean Difference (Net)|-0.24|Standard Error of the Mean|0.532|<|0.652|2-Sided|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the post-treatment and 6-month follow-up.|
1637426|NCT01967342|3009093|Superiority or Other||Mean Difference (Net)|-1.086|Standard Error of the Mean|0.623|<|0.082|2-Sided|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in PHQ-9 within Usual Care group between the pre-treatment and 10-week post-treatment.|
1637427|NCT01967342|3009094|Superiority or Other||Mean Difference (Net)|0.25|Standard Error of the Mean|0.243||0.305|2-Sided|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the post-treatment and 6-month follow-up.|
1637428|NCT01967342|3009094|Superiority or Other||Mean Difference (Net)|-0.999|Standard Error of the Mean|0.244|<|0.001|2-Sided|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Pain Ed group between the pre-treatment and 10-week post-treatment.|
1637429|NCT01967342|3009094|Superiority or Other||Mean Difference (Net)|0.548|Standard Error of the Mean|0.237|<|0.021|2-Sided|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the post-treatment and 6-month follow-up.|
1637430|NCT01967342|3009094|Superiority or Other||Mean Difference (Net)|-1.643|Standard Error of the Mean|0.241|<|0.001|2-Sided|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within CBT for Pain group between the pre-treatment and 10-week post-treatment.|
1637431|NCT01967342|3009094|Superiority or Other||Mean Difference (Net)|0.182|Standard Error of the Mean|0.239|<|0.447|2-Sided|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the post-treatment and 6-month follow-up.|
1637432|NCT01967342|3009094|Superiority or Other||Mean Difference (Net)|-0.31|Standard Error of the Mean|0.247|<|0.196|2-Sided|||||To control for multiple comparisons in secondary outcomes, a corrected alpha level was calculated using the Benjamini-Hochberg correction method. Smallest p-value compared to .025; Largest p-value compared to .050.|Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Interference within Usual Care group between the pre-treatment and 10-week post-treatment.|
1637433|NCT01967342|3009095|Superiority or Other||Mean Difference (Net)|0.131|Standard Error of the Mean|0.203||0.519|2-Sided||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the post-treatment and 6-month follow-up.|
1637434|NCT01967342|3009095|Superiority or Other||Mean Difference (Net)|-0.823|Standard Error of the Mean|0.191|<|0.001|2-Sided||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Pain Ed group between the pre-treatment and 10-week post-treatment.|
1637435|NCT01967342|3009095|Superiority or Other||Mean Difference (Net)|0.361|Standard Error of the Mean|0.199|<|0.07|2-Sided||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the post-treatment and 6-month follow-up.|
1637436|NCT01967342|3009095|Superiority or Other||Mean Difference (Net)|-1.052|Standard Error of the Mean|0.189|<|0.001|2-Sided||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within CBT group between the pre-treatment and 10-week post-treatment.|
1637437|NCT01967342|3009095|Superiority or Other||Mean Difference (Net)|-0.245|Standard Error of the Mean|0.198|<|0.216|2-Sided||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between post-treatment and 6-month follow-up.|
1637438|NCT01967342|3009095|Superiority or Other||Mean Difference (Net)|-0.268|Standard Error of the Mean|-0.193|<|0.165|2-Sided||||||Mixed Models Analysis|||A piecewise linear growth model examined changes in BPI-Intensity within Usual Care between pre-treatment and 10-week post-treatment.|
1637439|NCT01967277|3009097|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||H0: µL ≤ µs Versus Ha: µL > µs|
1637440|NCT01967173|3009104|Superiority|||||||0.096|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Fluticasone 250 compared to Fluticasone 100 is equal to the inferiority of Fluticasone 250 compared to Fluticasone 100|
1637441|NCT01967173|3009104|Superiority|||||||0.14|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 100 is equal to the inferiority of Advair 100/50 compared to Fluticasone 100|
1637442|NCT01967173|3009104|Superiority|||||||0.48|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Fluticasone 500 compared to Fluticasone 250 is equal to the inferiority of Fluticasone 500 compared to Fluticasone 250|
1637443|NCT01967173|3009104|Superiority|||||||0.62|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250|
1637444|NCT01967173|3009104|Superiority|||||||0.085|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 250 is equal to the inferiority of Advair 250/50 compared to Fluticasone 250|
1637445|NCT01967173|3009104|Superiority|||||||0.015|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 250/50 compared to Fluticasone 500 is equal to the inferiority of Advair 250/50 compared to Fluticasone 500|
1637446|NCT01967173|3009104|Superiority|||||||0.84|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50|
1638260|NCT01948141|3011472|Superiority or Other|||||||0.59|||||||Log Rank||||
1637447|NCT01967173|3009104|Superiority|||||||0.42|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Advair 250/50 is equal to the inferiority of Advair 100/50 compared to Advair 250/50|
1637448|NCT01967173|3009104|Superiority||||||<|0.001|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 500 is equal to the inferiority of Advair 100/50 compared to Fluticasone 500|
1637449|NCT01967173|3009104|Superiority||||||<|0.9|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250|
1637450|NCT01967173|3009104|Superiority||||||<|0.003|||||||Mixed Models Analysis|||Test of the null hypothesis that the superiority of Advair 100/50 compared to Fluticasone 250 is equal to the inferiority of Advair 100/50 compared to Fluticasone 250|
1637451|NCT01966926|3009125|Non-Inferiority or Equivalence (legacy)|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.93||||0.17||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was <0.05.|MANOVA|Degrees of freedom: 1,28||Repeated measures analysis from three to six months.|
1637452|NCT01966926|3009126|Non-Inferiority or Equivalence (legacy)|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.91||||0.3||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was <0.05.|MANOVA|Degrees of freedom: 2,26||Repeated measures analysis from baseline to six months.|
1637453|NCT01966926|3009127|Non-Inferiority or Equivalence (legacy)|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.87||||0.15||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance was <0.05.|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.|
1637454|NCT01966926|3009128|Non-Inferiority or Equivalence (legacy)|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.95||||0.5||||||P-value is unadjusted; a priori threshold for statistical significance was <0.05.|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.|
1637455|NCT01966926|3009129|Non-Inferiority or Equivalence (legacy)|Power not calculated due to small sample size and pilot study intent.|Wilks' Lambda|0.96||||0.61||||||P-value not adjusted for multiple comparisons; a priori threshold of <0.05 for statistical significance|MANOVA|Degrees of freedom: 2,27||Repeated measures analysis from baseline to six months.|
1637456|NCT01966926|3009130|Non-Inferiority or Equivalence (legacy)|Power not calculated due to small sample size and pilot study intent.|chi square|2.05||||0.15|2-Sided|||||P-value was unadjusted, with an a priori threshold for statistical significance set at p <.05.|Chi-squared|1 degree of freedom|||
1637457|NCT01966458|3009177|Superiority|||||||0.0354|||||||Chi-squared||||
1637458|NCT01966458|3009177|Non-Inferiority|The non-inferiority margin on the difference in success proportions is 15%.|Difference in Percentages|-9.2|||<|0.0001|2-Sided|90.0|-17.2|-1.1|||Farrington-Manning asymptotic test||Difference = Control success rate - HeartWare® VAS success rate Two-sided 90% exact binomial confidence interval is used||
1637459|NCT01966458|3009178|Superiority||Percent of Participants|19.2||||0.7363|2-Sided|90.0|15.6|23.3|||Exact Binomial Test||Two-sided exact binomial confidence interval used|The first secondary endpoint is the percent of participants with stroke/TIA at 12 months on the originally implanted device. It will be compared to 17.7%, which is the lower bound of a pre-defined margin of superiority based on the Endurance clinical trial.|
1637460|NCT01966458|3009179|Non-Inferiority|A non-inferiority margin of 6% was pre-specified.|Risk Difference (RD)|2.6||||0.1444|2-Sided|90.0|-5.5|10.7|||Farrington-Manning asymptotic test||Difference = HeartWare® VAS incidence rate - Control incidence rate Two-sided 90% exact binomial confident interval is used.|The primary endpoint is a non-inferiority test comparing HeartWare® VAS to Control.|
1637461|NCT01966107|3009223|Non-Inferiority|Estimate of the hazard ratio and its 95% CI for comparing aclidinium bromide 400 μg versus placebo were derived using the Cox proportional hazard model. A hazard ratio <1 represents a favorable outcome for aclidinium bromide 400 μg.|Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.64|1.23||||||Composite MACE|
1637462|NCT01966107|3009225|Superiority||Rate ratio|0.65||||0.006|2-Sided|95.0|0.48|0.89|||Negative Binomial Regression model||||A rate ratio <1 represents a favorable outcome for aclidinium bromide 400 μg.
1637463|NCT01966042|3009231|Superiority or Other||||||<|0.001|||||||Friedman test (n=13)||||
1637464|NCT01966003|3009232|Superiority or Other||Hazard Ratio (HR)|1.1|||||2-Sided|90.0|0.75|1.61||||||Hazard ratio for ABP 215 relative to bevacizumab, based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.|
1637465|NCT01966003|3009235|Superiority or Other||Hazard Ratio (HR)|1.03|||||2-Sided|90.0|0.83|1.29||||||The hazard ratio for ABP 215 relative to bevacizumab was based on a stratified Cox proportional hazards model. Stratification factors are geographic region, ECOG performance status, and sex.|
1637466|NCT01966003|3009237|Superiority or Other||Risk Difference (RD)|-2.9|||||2-Sided|90.0|-9.26|3.45||||||Risk difference (ABP 215 - Bevacizumab) and 90% CI were estimated using a generalized linear model adjusted for the randomization stratification factors geographic region, ECOG performance status, and sex.|
1637467|NCT01966003|3009237|Non-Inferiority or Equivalence|Clinical equivalence of the primary endpoint was demonstrated by comparing the 2-sided 90% CI of the risk ratio in objective response rate between ABP 215 and bevacizumab with an equivalence margin of (0.67, 1.5).|Risk Ratio (RR)|0.93|||||2-Sided|90.0|0.8|1.09||||||The risk ratio (ABP 215/Bevacizumab) and 90% confidence interval (CI) were estimated using a generalized linear model adjusted for the stratification factors (region, sex, and ECOG performance status).|
1637468|NCT01965652|3009272|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1637469|NCT01965652|3009273|Superiority or Other||LS Mean Difference|-0.48|Standard Error of the Mean|0.083|<|0.0001|2-Sided|95.0|-0.64|-0.32|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis|
1637470|NCT01965652|3009273|Superiority or Other||LS Mean Difference|-0.54|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.69|-0.38|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis|
1637471|NCT01965652|3009273|Superiority or Other||LS Mean Difference|-0.51|Standard Error of the Mean|0.077|<|0.0001|2-Sided|95.0|-0.66|-0.36|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis|
1637472|NCT01965652|3009273|Superiority or Other||LS Mean Difference|-0.58|Standard Error of the Mean|0.075|<|0.0001|2-Sided|95.0|-0.73|-0.43|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis|
1637473|NCT01965652|3009273|Superiority or Other||LS Mean Difference|-0.67|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|-0.81|-0.53|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis|
1637474|NCT01965652|3009274|Superiority or Other||LS Mean Difference|-0.32|Standard Error of the Mean|0.064|<|0.0001|2-Sided|95.0|-0.44|-0.19|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis|
1637475|NCT01965652|3009274|Superiority or Other||LS Mean Difference|-0.42|Standard Error of the Mean|0.062|<|0.0001|2-Sided|95.0|-0.54|-0.3|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis|
1637476|NCT01965652|3009274|Superiority or Other||LS Mean Difference|-0.33|Standard Error of the Mean|0.061|<|0.0001|2-Sided|95.0|-0.45|-0.21|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis|
1637477|NCT01965652|3009274|Superiority or Other||LS Mean Difference|-0.36|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.48|-0.24|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis|
1637478|NCT01965652|3009274|Superiority or Other||LS Mean Difference|-0.39|Standard Error of the Mean|0.054|<|0.0001|2-Sided|95.0|-0.5|-0.29|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis|
1637479|NCT01965652|3009275|Superiority or Other||LS Mean Difference|-0.21|Standard Error of the Mean|0.061||0.0006|2-Sided|95.0|-0.33|-0.09|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis|
1637480|NCT01965652|3009275|Superiority or Other||LS Mean Difference|-0.31|Standard Error of the Mean|0.059|<|0.0001|2-Sided|95.0|-0.43|-0.19|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis|
1637481|NCT01965652|3009275|Superiority or Other||LS Mean Difference|-0.25|Standard Error of the Mean|0.057|<|0.0001|2-Sided|95.0|-0.36|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis|
1637482|NCT01965652|3009275|Superiority or Other||LS Mean Difference|-0.24|Standard Error of the Mean|0.055|<|0.0001|2-Sided|95.0|-0.35|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis|
1637483|NCT01965652|3009275|Superiority or Other||LS Mean Difference|-0.24|Standard Error of the Mean|0.051|<|0.0001|2-Sided|95.0|-0.34|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis|
1637484|NCT01965652|3009276|Superiority or Other||LS Mean Difference|-0.28|Standard Error of the Mean|0.067|<|0.0001|2-Sided|95.0|-0.41|-0.15|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis|
1637485|NCT01965652|3009276|Superiority or Other||LS Mean Difference|-0.34|Standard Error of the Mean|0.068|<|0.0001|2-Sided|95.0|-0.48|-0.21|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis|
1637486|NCT01965652|3009276|Superiority or Other||LS Mean Difference|-0.27|Standard Error of the Mean|0.065|<|0.0001|2-Sided|95.0|-0.4|-0.15|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis|
1637487|NCT01965652|3009276|Superiority or Other||LS Mean Difference|-0.32|Standard Error of the Mean|0.063|<|0.0001|2-Sided|95.0|-0.44|-0.2|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Anaysis|
1637488|NCT01965652|3009276|Superiority or Other||LS Mean Difference|-0.39|Standard Error of the Mean|0.056|<|0.0001|2-Sided|95.0|-0.5|-0.28|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis|
1637489|NCT01965652|3009277|Superiority or Other||LS Mean Difference|-0.31|Standard Error of the Mean|0.056|<|0.0001|2-Sided|95.0|-0.42|-0.2|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis|
1637490|NCT01965652|3009277|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.055|<|0.0001|2-Sided|95.0|-0.5|-0.29|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis|
1637491|NCT01965652|3009277|Superiority or Other||LS Mean Difference|-0.33|Standard Error of the Mean|0.054|<|0.0001|2-Sided|95.0|-0.43|-0.22|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis|
1637553|NCT01964716|3009511|Superiority or Other||percent difference|0.0|||||2-Sided|95.0|-2.3|2.3||||||Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637492|NCT01965652|3009277|Superiority or Other||LS Mean Difference|-0.36|Standard Error of the Mean|0.051|<|0.0001|2-Sided|95.0|-0.46|-0.26|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis|
1637493|NCT01965652|3009277|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.047|<|0.0001|2-Sided|95.0|-0.49|-0.3|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis|
1637494|NCT01965652|3009278|Superiority or Other||LS Mean Difference|-0.37|Standard Error of the Mean|0.072|<|0.0001|2-Sided|95.0|-0.52|-0.23|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis|
1637495|NCT01965652|3009278|Superiority or Other||LS Mean Difference|-0.48|Standard Error of the Mean|0.071|<|0.0001|2-Sided|95.0|-0.62|-0.34|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis|
1637496|NCT01965652|3009278|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.067|<|0.0001|2-Sided|95.0|-0.54|-0.27|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis|
1637497|NCT01965652|3009278|Superiority or Other||LS Mean Difference|-0.38|Standard Error of the Mean|0.066|<|0.0001|2-Sided|95.0|-0.51|-0.26|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis|
1637498|NCT01965652|3009278|Superiority or Other||LS Mean Difference|-0.51|Standard Error of the Mean|0.063|<|0.0001|2-Sided|95.0|-0.64|-0.39|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis|
1637499|NCT01965652|3009279|Superiority or Other||LS Mean Difference|-0.17|Standard Error of the Mean|0.066||0.0119|2-Sided|95.0|-0.29|-0.04|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis|
1637500|NCT01965652|3009279|Superiority or Other||LS Mean Difference|-0.25|Standard Error of the Mean|0.064|<|0.0001|2-Sided|95.0|-0.38|-0.13|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis|
1637501|NCT01965652|3009279|Superiority or Other||LS Mean Difference|-0.23|Standard Error of the Mean|0.065|<|0.0003|2-Sided|95.0|-0.36|-0.11|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis|
1637502|NCT01965652|3009279|Superiority or Other||LS Mean Difference|-0.16|Standard Error of the Mean|0.063|<|0.0114|2-Sided|95.0|-0.28|-0.04|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis|
1637503|NCT01965652|3009279|Superiority or Other||LS Mean Difference|-0.25|Standard Error of the Mean|0.057|<|0.0001|2-Sided|95.0|-0.37|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis|
1637504|NCT01965652|3009280|Superiority or Other||LS Mean Difference|-0.14|Standard Error of the Mean|0.064||0.0336|2-Sided|95.0|-0.26|-0.01|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis|
1637505|NCT01965652|3009280|Superiority or Other||LS Mean Difference|-0.28|Standard Error of the Mean|0.061|<|0.0001|2-Sided|95.0|-0.4|-0.16|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis|
1637506|NCT01965652|3009280|Superiority or Other||LS Mean Difference|-0.18|Standard Error of the Mean|0.061|<|0.0035|2-Sided|95.0|-0.3|-0.06|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis|
1637507|NCT01965652|3009280|Superiority or Other||LS Mean Difference|-0.14|Standard Error of the Mean|0.06|<|0.0173|2-Sided|95.0|-0.26|-0.03|||Mixed-effects model repeated meaures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis|
1637508|NCT01965652|3009280|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.054|<|0.0002|2-Sided|95.0|-0.31|-0.1|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis|
1637509|NCT01965652|3009281|Superiority or Other||LS Mean Difference|-0.24|Standard Error of the Mean|0.059|<|0.0001|2-Sided|95.0|-0.35|-0.12|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis|
1637510|NCT01965652|3009281|Superiority or Other||LS Mean Difference|-0.35|Standard Error of the Mean|0.057|<|0.0001|2-Sided|95.0|-0.47|-0.24|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis|
1637511|NCT01965652|3009281|Superiority or Other||LS Mean Difference|-0.29|Standard Error of the Mean|0.056|<|0.0001|2-Sided|95.0|-0.4|-0.18|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis|
1637512|NCT01965652|3009281|Superiority or Other||LS Mean Difference|-0.25|Standard Error of the Mean|0.055|<|0.0001|2-Sided|95.0|-0.36|-0.14|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis|
1637554|NCT01964716|3009511|Superiority or Other||percent difference|-1.2|||||2-Sided|95.0|-4.4|1.1||||||Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637513|NCT01965652|3009281|Superiority or Other||LS Mean Difference|-0.35|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.44|-0.25|||Mixed-effects model repeated measures|The mixed-effects model repeated measures (MMRM) method included treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 2 Analysis|
1637514|NCT01965652|3009283|Superiority or Other||LS Mean Difference|1.0|Standard Error of the Mean|0.259||0.0001|2-Sided|95.0|0.49|1.51|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 52 Analysis|
1637515|NCT01965652|3009283|Superiority or Other||LS Mean Difference|1.01|Standard Error of the Mean|0.249|<|0.0001|2-Sided|95.0|0.52|1.5|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 36 Analysis|
1637516|NCT01965652|3009283|Superiority or Other||LS Mean Difference|1.0|Standard Error of the Mean|0.24|<|0.0001|2-Sided|95.0|0.53|1.47|||Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 24 Analysis|
1637517|NCT01965652|3009283|Superiority or Other||LS Mean Difference|1.28|Standard Error of the Mean|0.226|<|0.0001|2-Sided|95.0|0.83|1.72||The significance level was set at 0.05 (2-sided). The analysis of efficacy endpoints was not adjusted for multiplicity; hence, the p-values are purely nominal. A mixed-effects model repeated measures (MMRM) method was used for the comparisons.|Mixed-effects model repeated measures|The MMRM method included the opioid dose strata as a covariate and treatment group, time, and time-by-treatment group interaction as fixed effects.||Week 12 Analysis|
1637518|NCT01965535|3009304|Superiority or Other||difference in proportions|1.4|||||2-Sided|95.0|-5.9|8.6|||||The 2-sided 95% confidence interval (CI) on the difference in SVR12 rates between the 2 treatment groups was constructed based on stratum-adjusted Mantel-Haenszel (MH) proportions.|A sample size of 75 subjects in each treatment group would provide 80% power to detect a difference of 15% in SVR12 rates (80% vs 95%) between the 2 treatment groups.|
1637519|NCT01965431|3009305|Superiority or Other||Mean Difference (Net)|-4.42|Standard Error of the Mean|0.94|||2-Sided|90.0|-5.98|-2.87|||||Minimum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' & 'period−global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.|
1637520|NCT01965431|3009306|Superiority or Other||Mean Difference (Net)|0.17|Standard Error of the Mean|0.94|||2-Sided|90.0|-1.38|1.73|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' & 'period−global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.|
1637521|NCT01965431|3009307|Superiority or Other||Mean Difference (Net)|12.7|Standard Error of the Mean|2.02|||2-Sided|90.0|9.32|16.08|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' & 'period−global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.|No formal hypothesis testing was done.|
1637522|NCT01965431|3009308|Non-Inferiority or Equivalence|Non-inferiority margin is the maximum acceptable extent of statistical and clinical noninferiority of an experimental treatment. Non-inferiority margin for this trial is 10ms.|Mean Difference (Net)|7.9|Standard Error of the Mean|1.52|||2-Sided|90.0|5.37|10.43|||||Maximum mean difference to placebo is estimated. Adjusted means are based on a mixed model for repeated measures with 'global' & 'period−global baseline' covariates. Toeplitz covariance model used for modelling the random and repeated effect.||
1637523|NCT01965327|3009311|Superiority or Other|||||||0.0078|||||||t-test, 2 sided||||
1637524|NCT01965327|3009312|Superiority or Other|||||||0.027|||||||t-test, 2 sided|Missing data were imputed by last observation carried forward.|||
1637525|NCT01965158|3009451|Superiority or Other||LS Mean Difference|0.73|Standard Error of the Mean|0.198||0.0003|2-Sided|95.0|0.34|1.12|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.|||
1637526|NCT01965158|3009452|Superiority or Other||LS Mean Difference|1.01|Standard Error of the Mean|0.24|<|0.0001|2-Sided|95.0|0.54|1.48|||ANCOVA|ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.|||
1637527|NCT01965158|3009453|Superiority or Other||LS Mean Difference|2.11|Standard Error of the Mean|0.26|<|0.0001|2-Sided|95.0|1.6|2.63|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.|||
1637528|NCT01965158|3009454|Superiority or Other||LS Mean Difference|1.3|Standard Error of the Mean|0.271|<|0.0001|2-Sided|95.0|0.77|1.83|||ANCOVA|The ANCOVA model has the terms for treatment group as a fixed effect and the opioid dose strata as a covariate.|||
1637529|NCT01965158|3009455|Superiority or Other||Difference|13.0|Standard Error of the Mean|4.19||0.002|2-Sided|95.0|4.8|21.3||To control the overall type I error rate to be ≤ 0.05 for the primary and secondary efficacy endpoints, a fixed-sequence (hierarchical) testing approach was applied.|Cochran-Mantel-Haenszel|P-value was calculated by Cochran-Mantel-Haenszel test adjusted by the opioid dose strata.|||
1637530|NCT01964716|3009510|Superiority or Other||GMT Ratio|0.9|||||2-Sided|95.0|0.67|1.25||||||Serotype 23F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637531|NCT01964716|3009510|Superiority or Other||GMT Ratio|0.9|||||2-Sided|95.0|0.71|1.18||||||Serotype 19F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637532|NCT01964716|3009510|Superiority or Other||GMT Ratio|0.9|||||2-Sided|95.0|0.74|1.16||||||Serotype 19A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1638261|NCT01948076|3011477|Superiority or Other|||||||0.043|||||||McNemar||||
1637533|NCT01964716|3009510|Superiority or Other||GMT Ratio|1.7|||||2-Sided|95.0|1.38|2.19||||||Serotype 18C: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637534|NCT01964716|3009510|Superiority or Other||GMT Ratio|0.7|||||2-Sided|95.0|0.48|1.08||||||Serotype 14: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637535|NCT01964716|3009510|Superiority or Other||GMT Ratio|1.0|||||2-Sided|95.0|0.79|1.27||||||Serotype 9V: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637536|NCT01964716|3009510|Superiority or Other||GMT Ratio|0.8|||||2-Sided|95.0|0.7|1.0||||||Serotype 7F: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637537|NCT01964716|3009510|Superiority or Other||GMT Ratio|1.0|||||2-Sided|95.0|0.74|1.33||||||Serotype 6B: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637538|NCT01964716|3009510|Superiority or Other||GMT Ratio|0.9|||||2-Sided|95.0|0.7|1.06||||||Serotype 6A: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637539|NCT01964716|3009510|Superiority or Other||GMT Ratio|1.0|||||2-Sided|95.0|0.8|1.22||||||Serotype 5: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637540|NCT01964716|3009510|Superiority or Other||GMT Ratio|1.1|||||2-Sided|95.0|0.89|1.39||||||Serotype 4: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637541|NCT01964716|3009510|Superiority or Other||GMT Ratio|0.8|||||2-Sided|95.0|0.69|0.93||||||Serotype 3: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637542|NCT01964716|3009510|Superiority or Other||GMT Ratio|0.9|||||2-Sided|95.0|0.7|1.2||||||Serotype 1: Ratio of GMTs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637543|NCT01964716|3009511|Superiority or Other||percent difference|-1.3|||||2-Sided|95.0|-5.8|3.0||||||Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637544|NCT01964716|3009511|Superiority or Other||percent difference|-0.7|||||2-Sided|95.0|-6.3|4.9||||||Serotype 19F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637545|NCT01964716|3009511|Superiority or Other||percent difference|-1.9|||||2-Sided|95.0|-6.6|2.4||||||Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637546|NCT01964716|3009511|Superiority or Other||percent difference|0.0|||||2-Sided|95.0|-2.9|2.9||||||Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637547|NCT01964716|3009511|Superiority or Other||percent difference|-7.8|||||2-Sided|95.0|-15.8|0.0||||||Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637548|NCT01964716|3009511|Superiority or Other||percent difference|4.7|||||2-Sided|95.0|-4.5|14.1||||||Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637549|NCT01964716|3009511|Superiority or Other||percent difference|0.0|||||2-Sided|95.0|-2.3|2.3||||||Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637550|NCT01964716|3009511|Superiority or Other||percent difference|0.0|||||2-Sided|95.0|-4.5|4.6||||||Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637551|NCT01964716|3009511|Superiority or Other||percent difference|0.0|||||2-Sided|95.0|-2.9|2.8||||||Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637552|NCT01964716|3009511|Superiority or Other||percent difference|-2.4|||||2-Sided|95.0|-10.6|5.7||||||Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637597|NCT01964352|3009551|Superiority or Other||Mean Difference (Final Values)|0.398|Standard Error of the Mean|0.034|<|0.0001|2-Sided|95.0|0.331|0.465|||Mixed Effects Model for Repeated Measure||||
1637555|NCT01964716|3009511|Superiority or Other||percent difference|-7.7|||||2-Sided|95.0|-17.2|1.9||||||Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637556|NCT01964716|3009520|Non-Inferiority or Equivalence|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.2|||||2-Sided|97.5|0.98|1.48||||||Serotype 23F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637557|NCT01964716|3009520|Non-Inferiority or Equivalence|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.04|||||2-Sided|97.5|0.85|1.26||||||Serotype 19F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637558|NCT01964716|3009520|Non-Inferiority or Equivalence|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.01|||||2-Sided|97.5|0.82|1.24||||||Serotype 19A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637559|NCT01964716|3009520|Non-Inferiority or Equivalence|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.28|||||2-Sided|97.5|1.09|1.49||||||Serotype 18C: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637560|NCT01964716|3009520|Non-Inferiority or Equivalence|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.96|||||2-Sided|97.5|0.75|1.24||||||Serotype 14: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637561|NCT01964716|3009520|Non-Inferiority or Equivalence|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||2-Sided|97.5|0.87|1.21||||||Serotype 9V: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637562|NCT01964716|3009520|Non-Inferiority or Equivalence|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.94|||||2-Sided|97.5|0.82|1.08||||||Serotype 7F: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637563|NCT01964716|3009520|Non-Inferiority or Equivalence|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.06|||||2-Sided|97.5|0.82|1.36||||||Serotype 6B: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637564|NCT01964716|3009520|Non-Inferiority or Equivalence|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||2-Sided|97.5|0.86|1.22||||||Serotype 6A: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637565|NCT01964716|3009520|Non-Inferiority or Equivalence|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.01|||||2-Sided|97.5|0.85|1.19||||||Serotype 5: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637566|NCT01964716|3009520|Non-Inferiority or Equivalence|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.0|||||2-Sided|97.5|0.86|1.18||||||Serotype 4: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637567|NCT01964716|3009520|Non-Inferiority or Equivalence|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|0.79|||||2-Sided|97.5|0.71|0.9||||||Serotype 3: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637568|NCT01964716|3009520|Non-Inferiority or Equivalence|Non-inferiority for a given antibody serotype was declared if lower bound of the 2-sided, 97.5% confidence interval for the geometric mean concentration ratio (GMC MDV /GMC SDS) was greater than 0.5 (2-fold criterion).|GMC Ratio|1.03|||||2-Sided|97.5|0.87|1.22||||||Serotype 1: Ratio of GMCs, MDV to SDS, was calculated by back transforming the mean difference between the vaccine groups on the logarithmic scale; CIs for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC MDV – 13vPnC SDS).|
1637569|NCT01964716|3009521|Non-Inferiority or Equivalence|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV – 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||2-Sided|97.5|-4.3|4.4||||||Serotype 23F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637570|NCT01964716|3009521|Superiority or Other||percentage difference|-0.4|||||2-Sided|97.5|-4.4|3.5||||||Serotype 19F: Exact 2-sided confidence interval (based on Chan & Zhang) for the difference in proportions, 13vPnC multidose vial (MDV) – 13vPnC single-dose syringe (SDS), expressed as a percentage was analyzed.|
1637571|NCT01964716|3009521|Non-Inferiority or Equivalence|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV – 13vPnC SDS) was greater than -0.10.|percent difference|0.8|||||2-Sided|97.5|-1.6|3.6||||||Serotype 19A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637572|NCT01964716|3009521|Non-Inferiority or Equivalence|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV – 13vPnC SDS) was greater than -0.10.|percent difference|1.2|||||2-Sided|97.5|-1.6|4.5||||||Serotype 18C: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637573|NCT01964716|3009521|Non-Inferiority or Equivalence|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV – 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||2-Sided|97.5|-4.3|2.5||||||Serotype 14: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637574|NCT01964716|3009521|Non-Inferiority or Equivalence|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV – 13vPnC SDS) was greater than -0.10.|percent difference|-0.4|||||2-Sided|97.5|-3.8|2.8||||||Serotype 9V: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637575|NCT01964716|3009521|Non-Inferiority or Equivalence|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV – 13vPnC SDS) was greater than -0.10.|percent difference|-0.4|||||2-Sided|97.5|-2.7|1.6||||||Serotype 7F: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637576|NCT01964716|3009521|Non-Inferiority or Equivalence|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV – 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||2-Sided|97.5|-4.7|4.7||||||Serotype 6B: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637577|NCT01964716|3009521|Non-Inferiority or Equivalence|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV – 13vPnC SDS) was greater than -0.10.|percent difference|-1.2|||||2-Sided|97.5|-5.3|2.6||||||Serotype 6A: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637578|NCT01964716|3009521|Non-Inferiority or Equivalence|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV – 13vPnC SDS) was greater than -0.10.|percent difference|-1.2|||||2-Sided|97.5|-5.4|2.8||||||Serotype 5: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637579|NCT01964716|3009521|Non-Inferiority or Equivalence|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV – 13vPnC SDS) was greater than -0.10.|percent difference|0.0|||||2-Sided|97.5|-2.3|2.4||||||Serotype 4: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637580|NCT01964716|3009521|Non-Inferiority or Equivalence|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV – 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||2-Sided|97.5|-3.7|1.6||||||Serotype 3: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637581|NCT01964716|3009521|Non-Inferiority or Equivalence|Non-inferiority for a given antibody was demonstrated if the lower bound of the 2-sided, 97.5% confidence interval, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC MDV – 13vPnC SDS) was greater than -0.10.|percent difference|-0.8|||||2-Sided|97.5|-3.4|1.2||||||Serotype 1: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC MDV – 13vPnC SDS, expressed as a percentage was analyzed.|
1637582|NCT01964547|3009523|Superiority or Other||Hodges-Lehmann median difference|-1.0||||0.088|2-Sided|95.0|-3.0|0.0|||Wilcoxon (Mann-Whitney)|||The change at end of treatment was compared between treatment groups using non-parametric methods as the distribution of data was non-normal.|
1637583|NCT01964547|3009523|Superiority or Other||Estimated mean treatment difference|4.88|Standard Error of the Mean|8.25||0.556|2-Sided|95.0|-11.51|21.27|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and centre grouping as factors and baseline score as covariate.|
1637584|NCT01964547|3009526|Superiority or Other||Estimated mean treatment difference|-2.36|Standard Error of the Mean|1.88||0.212|2-Sided|95.0|-6.09|1.37|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.|
1637585|NCT01964547|3009527|Superiority or Other||Odds Ratio (OR)|3.07||||0.0019|2-Sided|95.0|1.51|6.21|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.|
1637586|NCT01964547|3009528|Superiority or Other||Odds Ratio (OR)|2.79||||0.0142|2-Sided|95.0|1.23|6.31|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.|
1637587|NCT01964547|3009529|Superiority or Other||Odds Ratio (OR)|4.02||||0.0001|2-Sided|95.0|1.96|8.22|||Regression, Logistic|||Data were analysed using ordinal logistic regression using the cumulative proportional odds model, with global impression of change as the dependent variable and treatment group as factor.|
1637588|NCT01964547|3009530|Non-Inferiority or Equivalence|Sativex is deemed to be non-inferior to placebo if the upper 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is less than +5%.|Estimated mean treatment difference|-0.29|Standard Error of the Mean|1.323|||1-Sided|97.5||2.33||||||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate.|
1637589|NCT01964547|3009531|Non-Inferiority or Equivalence|The sample size is adequate to confirm the non-inferiority of Sativex with a clinical relevant reduction delta of 10%, assuming there is no difference between treatments in the actual change in cognition and also assuming a standard deviation for treatment difference of 10, using a one-tailed 2.5% significance level and power of 90%. Sativex is deemed to be non-inferior to placebo if the lower 1-sided 97.5% CI of the estimated mean treatment difference (Sativex-Placebo) is greater than -10%.|Estimated mean treatment difference|-1.47|Standard Error of the Mean|2.492|||1-Sided|97.5|-6.41|||||||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment group and center grouping as factors and the baseline score as covariate. The planned sample size was 120 participants(60 patients in the Sativex arm and 60 in the placebo arm).|
1637590|NCT01964430|3009535|Superiority||Hazard Ratio (HR)|0.82||||0.045|2-Sided|95.0|0.68|0.996|||Log Rank|Stratified by resection status (R0 versus. R1) and nodal status (LN+ versus. LN-)|Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus||
1637591|NCT01964430|3009536|Superiority||Hazard Ratio (HR)|0.88||||0.1824|2-Sided|95.0|0.729|1.063|||Log Rank|Stratified by resection status (R0 versus R1) and nodal status (LN+ versus LN).|Estimated using stratified Cox proportional hazards model adjusting for strata of resection status (R0 versus R1) and nodal status (LN+ versus LN-).||
1637592|NCT01964378|3009549|Non-Inferiority|Non-inferiority margin of 8 mg. Assuming that 65% of the participants are available for the Per Protocol Set, a total of 524 participant would have to be allocated (randomized) to IMP. With 262 participants per group in the Full Analysis Set, the non-inferiority of cebranopadol as compared to morphine sulfate prolonged release could have been demonstrated with at least 98% power and a 1-sided significance level of α = 0.025.|point-estimate|-4.67|Standard Error of the Mean|2.3|<|0.0001|2-Sided|95.0|-9.245|-0.099||MMRM model: fixed effects of pooled country, treatment, week, treatment-by-week interaction, opioid intake history, baseline pain intensity as covariate & subject-specific random effects. Dependent variable: weekly average rescue medication intake.|MMRM (mixed model repeated measurement)|For participants with no data in the Maintenance Phase, the average amount of rescue medication over the last 3 days of titration was imputed.|Non-inferiority of cebranopadol compared with morphine will be established if the upper bound of the resulting 95% confidence interval for the average treatment difference is below the non-inferiority margin of 8mg.|The primary endpoint will be analyzed by means of a mixed-effects model for repeated measures (MMRM), based on observed case weekly averages. Under the assumption of a missing-at-random missing data mechanism, an MMRM does not require an imputation of missing data and can obtain an improved estimate of variance.|
1637593|NCT01964378|3009550|Non-Inferiority|Non-inferiority margin of 8 mg. Assuming equal mean values in both the cebranopadol and morphine groups, it was calculated that for the final analysis of the primary endpoint 170 subjects would have been required per treatment arm in the Per Protocol Set using a 2 sample-t-test for 90% power and a 1-sided significance level of α = 0.025.|point-estimate|-7.48|Standard Error of the Mean|2.3|<|0.0001|2-Sided|95.0|-12.05|-2.918|||MMRM|||The MMRM (mixed model repeated measurement) model includes fixed effects of pooled country, treatment, week, treatment-by-week interaction, history of opioid intake, baseline pain intensity as covariate & subject-specific random effects. Dependent variable being the weekly average rescue medication intake.|
1637594|NCT01964352|3009551|Superiority or Other||Mean Difference (Final Values)|0.059|Standard Error of the Mean|0.033||0.0701|2-Sided|95.0|-0.005|0.123|||Mixed Effects Model for Repeated Measure||||
1637595|NCT01964352|3009551|Superiority or Other||Mean Difference (Final Values)|0.297|Standard Error of the Mean|0.035|<|0.0001|2-Sided|95.0|0.229|0.365|||Mixed Effects Model for Repeated Measure||||
1637596|NCT01964352|3009551|Superiority or Other||Mean Difference (Final Values)|0.101|Standard Error of the Mean|0.033|<|0.0023|2-Sided|95.0|0.036|0.165|||Mixed Effects Model for Repeated Measure||||
1637598|NCT01964352|3009551|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.033|<|0.0001|2-Sided|95.0|0.095|0.225|||Mixed Effects Model for Repeated Measure||||
1637599|NCT01964352|3009551|Superiority or Other||Mean Difference (Final Values)|0.457|Standard Error of the Mean|0.034|<|0.0001|2-Sided|95.0|0.39|0.524|||Mixed Effects Model for Repeated Measure||||
1637600|NCT01964352|3009552|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.268||0.7081|2-Sided|95.0|-0.425|0.626|||Mixed Effects Model for Repeated Measure||||
1637601|NCT01964352|3009552|Superiority or Other||Mean Difference (Final Values)|1.445|Standard Error of the Mean|0.274|<|0.0001|2-Sided|95.0|0.907|1.983|||Mixed Effects Model for Repeated Measure||||
1637602|NCT01964352|3009552|Superiority or Other||Mean Difference (Final Values)|0.507|Standard Error of the Mean|0.269|<|0.0599|2-Sided|95.0|-0.021|1.035|||Mixed Effects Model for Repeated Measure||||
1637603|NCT01964352|3009552|Superiority or Other||Mean Difference (Final Values)|1.952|Standard Error of the Mean|0.272|<|0.0001|2-Sided|95.0|1.417|2.487|||Mixed Effects Model for Repeated Measure||||
1637604|NCT01964352|3009552|Superiority or Other||Mean Difference (Final Values)|0.607|Standard Error of the Mean|0.27|<|0.0246|2-Sided|95.0|0.078|1.137|||Mixed Effects Model for Repeated Measure||||
1637605|NCT01964352|3009552|Superiority or Other||Mean Difference (Final Values)|2.052|Standard Error of the Mean|0.273|<|0.0001|2-Sided|95.0|1.516|2.588|||Mixed Effects Model for Repeated Measure||||
1637606|NCT01964352|3009553|Superiority or Other||Mean Difference (Final Values)|0.011|Standard Error of the Mean|0.032||0.7199|2-Sided|95.0|-0.051|0.073|||Mixed Effects Model for Repeated Measure||||
1637607|NCT01964352|3009553|Superiority or Other||Mean Difference (Final Values)|0.198|Standard Error of the Mean|0.032|<|0.0001|2-Sided|95.0|0.136|0.261|||Mixed Effects Model for Repeated Measure||||
1637608|NCT01964352|3009553|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.032|<|0.7566|2-Sided|95.0|-0.052|0.072|||Mixed Effects Model for Repeated Measure||||
1637609|NCT01964352|3009553|Superiority or Other||Mean Difference (Final Values)|0.208|Standard Error of the Mean|0.032|<|0.0001|2-Sided|95.0|0.146|0.271|||Mixed Effects Model for Repeated Measure||||
1637610|NCT01964352|3009553|Superiority or Other||Mean Difference (Final Values)|0.021|Standard Error of the Mean|0.032|<|0.5052|2-Sided|95.0|-0.041|0.084|||Mixed Effects Model for Repeated Measure||||
1637611|NCT01964352|3009553|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.032|<|0.0001|2-Sided|95.0|0.157|0.282|||Mixed Effects Model for Repeated Measure||||
1637612|NCT01964352|3009554|Superiority or Other||Mean Difference (Final Values)|-0.772|Standard Error of the Mean|1.003||0.4415|2-Sided|95.0|-2.741|1.196|||Mixed Effects Model for Repeated Measure||||
1637613|NCT01964352|3009554|Superiority or Other||Mean Difference (Final Values)|-2.401|Standard Error of the Mean|1.029||0.0198|2-Sided|95.0|-4.419|-0.382|||Mixed Effects Model for Repeated Measure||||
1637614|NCT01964352|3009554|Superiority or Other||Mean Difference (Final Values)|-1.721|Standard Error of the Mean|1.008||0.088|2-Sided|95.0|-3.698|0.256|||Mixed Effects Model for Repeated Measure||||
1637615|NCT01964352|3009554|Superiority or Other||Mean Difference (Final Values)|-4.122|Standard Error of the Mean|1.023|<|0.0001|2-Sided|95.0|-6.129|-2.114|||Mixed Effects Model for Repeated Measure||||
1637616|NCT01964352|3009554|Superiority or Other||Mean Difference (Final Values)|-2.493|Standard Error of the Mean|1.009|<|0.0136|2-Sided|95.0|-4.473|-0.513|||Mixed Effects Model for Repeated Measure||||
1637617|NCT01964352|3009554|Superiority or Other||Mean Difference (Final Values)|-4.894|Standard Error of the Mean|1.024|<|0.0001|2-Sided|95.0|-6.904|-2.884|||Mixed Effects Model for Repeated Measure||||
1637618|NCT01964352|3009555|Superiority or Other||Mean Difference (Final Values)|0.012|Standard Error of the Mean|0.019||0.5333|2-Sided|95.0|-0.025|0.049|||Mixed Effects Model for Repeated Measure||||
1637619|NCT01964352|3009555|Superiority or Other||Mean Difference (Final Values)|0.134|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.096|0.172|||Mixed Effects Model for Repeated Measure||||
1637620|NCT01964352|3009555|Superiority or Other||Mean Difference (Final Values)|0.017|Standard Error of the Mean|0.019|<|0.3872|2-Sided|95.0|-0.021|0.054|||Mixed Effects Model for Repeated Measure||||
1637621|NCT01964352|3009555|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.113|0.188|||Mixed Effects Model for Repeated Measure||||
1637622|NCT01964352|3009555|Superiority or Other||Mean Difference (Final Values)|0.028|Standard Error of the Mean|0.019|<|0.1381|2-Sided|95.0|-0.009|0.066|||Mixed Effects Model for Repeated Measure||||
1637623|NCT01964352|3009555|Superiority or Other||Mean Difference (Final Values)|0.162|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.0124|0.2|||Mixed Effects Model for Repeated Measure||||
1637624|NCT01964352|3009556|Superiority or Other||Mean Difference (Final Values)|0.031|Standard Error of the Mean|0.018||0.0872|2-Sided|95.0|-0.005|0.067|||Mixed Effects Model for Repeated Measure||||
1637625|NCT01964352|3009556|Superiority or Other||Mean Difference (Final Values)|0.219|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.181|0.258|||Mixed Effects Model for Repeated Measure||||
1637626|NCT01964352|3009556|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.018|<|0.0001|2-Sided|95.0|0.044|0.116|||Mixed Effects Model for Repeated Measure||||
1637627|NCT01964352|3009556|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.262|0.337|||Mixed Effects Model for Repeated Measure||||
1637628|NCT01964352|3009556|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.075|0.148|||Mixed Effects Model for Repeated Measure||||
1637629|NCT01964352|3009556|Superiority or Other||Mean Difference (Final Values)|0.331|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.293|0.369|||Mixed Effects Model for Repeated Measure||||
1637630|NCT01963845|3009580|Superiority or Other|||||||0.556|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in HOMA-IR values from baseline to 24 weeks between the two groups.|
1637631|NCT01963845|3009581|Superiority or Other|||||||0.7984|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in LDL values from baseline to 24 weeks between the two groups.|
1637632|NCT01963845|3009582|Superiority or Other|||||||0.8569|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in ALT values from baseline to 24 weeks between the two groups.|
1637633|NCT01963845|3009583|Superiority or Other|||||||0.7583|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in AST values from baseline to 24 weeks between the two groups.|
1637634|NCT01963845|3009584|Superiority or Other|||||||0.585|||||||t-test, 2 sided||||
1637635|NCT01963767|3009585|Superiority or Other|||||||0.03|||||||ANCOVA|||Ancovas were conducted with group as the between subjects factor and performance at baseline as the covariate.|
1637636|NCT01963676|3009587|Superiority or Other|||||||0.86||||||There was no adjustment because we just performed one comparison|t-test, 2 sided|Difference from 1 Month to Baseline was compared between the sham and the tDCS group using an unpaired t-test. Degrees of freedom: df = 24||"The null hypothesis was that there is no difference between the AHRS score changes from baseline to 1month between the groups:~H0: μ1 = μ2 μ1: mean(difference 1 month-baseline) for tDCS group (n=13) μ2: mean(difference 1 month-baseline) for sham group (n=13)"|
1637637|NCT01963676|3009588|Superiority or Other|||||||0.48||||||There was no adjustment because we just performed one comparison|t-test, 2 sided|Difference from Day 5 to Baseline was compared between the sham and the tDCS group using an unpaired t-test. Degrees of freedom: df = 24||"The null hypothesis was that there is no difference between the changes in the AHRS score from baseline to 5 days between the groups:~H0: μ1 = μ2 μ1: mean(difference 5 days-baseline) for tDCS group (n=13) μ2: mean(difference 5 days-baseline) for sham group (n=13)"|
1637638|NCT01963169|3009629|Superiority||Effect size|0.14||||0.032|2-Sided|||||<0.05 (Threshold)|Mixed Models Analysis||The above values are for exercise outcome expectation.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.|
1637639|NCT01963169|3009629|Superiority||Effect Size|0.18||||0.002|2-Sided|||||<0.05 (Threshold)|Mixed Models Analysis||The above values are for exercise self-efficacy.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.|
1637640|NCT01963169|3009629|Superiority||Effect size|0.2||||0.009|2-Sided|||||<0.05 (Threshold)|Mixed Models Analysis||The above values are for calcium outcome expectation..|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.|
1637641|NCT01963169|3009629|Superiority||Effect size|0.33|||<|0.001|2-Sided|||||<0.05 (threshold)|Mixed Models Analysis||The above values are for the exercise behavior variable assessed by the 9-item Self-Efficacy for Exercise scale.|At 8 weeks both intervention groups received the same BonePower intervention. Thus the analysis of 8-week outcome was completed as 2-armed RCT.|
1637642|NCT01963169|3009629|Superiority||Effect size|0.54|||<|0.001|2-Sided|||||<0.05 (Threshold)|Mixed Models Analysis||The above values are for Knowledge outcome using the revised Osteoporosis Knowledge Test.|At 8 week, both intervention groups received the same Bone Power Program intervention. Thus, the analysis for the 8-week outcomes was completed as a two-armed RCT.|
1637643|NCT01962714|3009683|Non-Inferiority|For depression, the non-inferiority margin was 4 points on the PROMIS depression measure, which has been defined as the minimally important difference and corresponds to a Cohen’s d effect size of approximately 0.50.|Mean Difference (Final Values)|2.34|||||2-Sided|95.0|-0.52|5.2|||||Non-inferiority of LKM with respect to CPT-C was analyzed as the change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM), with a positive value indicating a greater reduction in scores from baseline for LKM compared to CPT-C.|The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.|
1637644|NCT01962714|3009684|Non-Inferiority|The primary outcome of non-inferiority of LKM relative to CPT-C was assessed using a non-inferiority margin of 5 points on the CAPS-5, which represents 0.5 SD of baseline PTSD symptoms based on data indicating the SD of baseline CAPS-5 scores is approximately 10 in a large sample (N=198) of treatment-seeking veterans.|Mean Difference (Final Values)|2.09|||||2-Sided|95.0|-2.59|6.78|||||Non-inferiority of LKM to CPT-C was analyzed as the change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM), with a positive value indicating a greater reduction in scores for LKM compared to CPT-C.|The non-inferiority of LKM with respect to CPT-C was analyzed using the 95% confidence interval for the group x time interaction term, with non-inferiority of LKM to CPT-C claimed if the lower limit of the 95% confidence interval was greater than (i.e., did not extend beyond) negative delta.|
1637645|NCT01962688|3009688|Other|||||||0.002|||||||Chi-squared||||
1637646|NCT01962493|3009708|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.155||0.1313|2-Sided|95.0|-0.51|0.1||Analysis based on square root transformation. Results back transformed for interpretation.|ANCOVA|Results were obtained from ANCOVA model with Site, Treatment, Treatment X Site, Smoking Status as fixed effects and baseline MLSI as a covariate.|Difference is first named treatment minus second named treatment. A negative difference favors the first named treatment|Null hypothesis stated that there was no difference between treatment groups|
1637647|NCT01961609|3009793|Superiority or Other||Percentage|65.3|||<|0.0001|2-Sided|99.375|52.4|76.7|||two-sided binomial exact test||A Bonferroni adjustment adjusting for 8 analyses have been applied.||
1637648|NCT01961362|3009797|Superiority||Median Difference (Net)|-0.07|Standard Error of the Mean|1.2|<|0.05|2-Sided||||||Mixed Models Analysis||||
1637649|NCT01961362|3009798|Superiority||Mean Difference (Net)|-0.07|Standard Error of the Mean|1.2|<|0.05|2-Sided||||||Mixed Models Analysis||||
1637650|NCT01961362|3009798|Superiority||Mean Difference (Net)|0.9|Standard Deviation|0.87|<|0.6|2-Sided|||||P<0.05 considered to represent statistical significance.|t-test, 2 sided||||
1637651|NCT01961349|3009799|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1637652|NCT01961349|3009799|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1637653|NCT01961349|3009800|Superiority or Other||||||<|0.001|||||||ANOVA||||
1637654|NCT01961349|3009800|Superiority or Other||||||<|0.001|||||||ANOVA||||
1637655|NCT01961089|3009860|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.21|||||||Paired t-test|||P-value comparing SimK between IOLM and LS|
1637656|NCT01961089|3009860|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.25|||||||Paired t-test|||P-value comparing SimK between G6 and LS|
1637657|NCT01961089|3009860|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test||||||0.13|||||||Paired t-test|||P-value comparing SimK between G6 and IOLM|
1638161|NCT01951326|3011112|Superiority|||||||0.0147|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).|||
1637658|NCT01961089|3009861|Superiority or Other (legacy)|||||||0.05|||||||ANOVA|||Repeatability was determined with random effect ANOVAs (estimates of random effects). They were calculated as the square root of the sum of the (Device x EyeID) interaction component plus (EyeID) and (Device) variance components plus the residual variance component. A (Device x Operator) interaction component was not assessed because each device was consistently operated by the same operator such that there was no Device x Operator interaction component. CV = Coefficient of Variation = SD/mean.|
1637659|NCT01961089|3009862|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.001|||||||Paired t-test|||P-value comparing WtW between IOLM and LS|
1637660|NCT01961089|3009862|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing WtW between G6 and LS|
1637661|NCT01961089|3009862|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing WtW between G6 and IOLM|
1637662|NCT01961089|3009862|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.01|||||||Paired t-test|||P-value comparing LT between G6 and LS|
1637663|NCT01961089|3009862|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.02|||||||Paired t-test|||P-value comparing ACD between IOLM and LS|
1637664|NCT01961089|3009862|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.01|||||||Paired t-test|||P-value comparing ACD between G6 and LS|
1637665|NCT01961089|3009862|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing ACD between G6 and IOLM|
1637666|NCT01961089|3009862|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing CCT between G6 and LS|
1637667|NCT01961089|3009862|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.0001|||||||Paired t-test|||P-value comparing AL between IOLM and LS|
1637668|NCT01961089|3009862|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test|||||<|0.001|||||||Paired t-test|||P-value comparing AL between G6 and LS|
1637669|NCT01961089|3009862|Equivalence|The significance of a difference in a measured parameter between two devices was assessed using a paired t-test.|||||<|0.09|||||||Paired t-test|||P-value comparing AL between G6 and IOLM|
1637670|NCT01960907|3009863|Superiority or Other|||||||0.038|||||||Wilcoxon (Mann-Whitney)||||
1637671|NCT01960907|3009864|Superiority or Other|||||||0.915|||||||t-test, 2 sided||||
1637672|NCT01960907|3009865|Superiority or Other|||||||0.342|||||||Log Rank||||
1637673|NCT01960855|3009866|Other||||||=|0|||||||Chi-squared||||
1637674|NCT01960855|3009866|Other||||||=|0|||||||Chi-squared||||
1637675|NCT01960855|3009866|Other||||||=|0|||||||Chi-squared||||
1637676|NCT01960855|3009866|Other||||||=|0|||||||Chi-squared||||
1637677|NCT01960855|3009867|Other||||||=|0|||||||Chi-squared||||
1637678|NCT01960855|3009867|Other||||||=|0|||||||Chi-squared||||
1637679|NCT01960855|3009867|Other||||||=|0|||||||Chi-squared||||
1637680|NCT01960855|3009867|Other||||||=|0|||||||Chi-squared||||
1637681|NCT01960855|3009868|Other||||||=|0|||||||Chi-squared||||
1637682|NCT01960855|3009868|Other||||||=|0|||||||Chi-squared||||
1637683|NCT01960855|3009868|Other||||||<|0.001|||||||Chi-squared||||
1637684|NCT01960855|3009868|Other||||||=|0|||||||Chi-squared||||
1637685|NCT01960855|3009869|Other||||||=|0|||||||Chi-squared||||
1637686|NCT01960855|3009869|Other||||||=|0|||||||Chi-squared||||
1637687|NCT01960855|3009869|Other||||||=|0|||||||Chi-squared||||
1637688|NCT01960855|3009869|Other||||||=|0|||||||Chi-squared||||
1637689|NCT01960855|3009870|Other||||||<|0.001|||||||Chi-squared||||
1637690|NCT01960855|3009870|Other||||||<|0.001|||||||Chi-squared||||
1637691|NCT01960855|3009870|Other||||||=|0|||||||Chi-squared||||
1637692|NCT01960855|3009870|Other||||||=|0|||||||Chi-squared||||
1637693|NCT01960842|3009879|Superiority or Other||Mean Difference (Net)|-4.58|||<|0.001|2-Sided|95.0|-5.73|-3.44|||One-sample t-test, 2-sided||||
1637694|NCT01960842|3009880|Superiority or Other||Mean Difference (Net)|-4.65|||<|0.001|2-Sided|95.0|-5.83|-3.47|||One-sample t-test, 2-sided||||
1637695|NCT01960842|3009881|Superiority or Other||Mean Difference (Net)|-3.2|||<|0.001|2-Sided|95.0|-4.4|-1.9|||One-sample t-test, 2-sided||||
1637696|NCT01960842|3009882|Superiority or Other||Mean Difference (Net)|-0.9|||=|0|2-Sided|95.0|-1.6|-0.2|||One-sample t-test, 2-sided||||
1637697|NCT01960842|3009883|Superiority or Other||Mean Difference (Net)|-4.8|||=|0|2-Sided|95.0|-9.8|0.1|||One-sample t-test, 2-sided||||
1637698|NCT01960842|3009884|Superiority or Other||Mean Difference (Net)|-17.8|||<|0.001|2-Sided|95.0|-25.2|-10.3|||One-sample t-test, 2-sided|||Bodily Discomfort Domain analysis.|
1637699|NCT01960842|3009884|Superiority or Other||Mean Difference (Net)|1.1|||=|0|2-Sided|95.0|-4.2|6.4|||One-sample t-test, 2-sided|||Communication Domain analysis.|
1637700|NCT01960842|3009884|Superiority or Other||Mean Difference (Net)|-14.0|||<|0.001|2-Sided|95.0|-20.7|-7.3|||One-sample t-test, 2-sided|||Cognition Domain analysis.|
1637701|NCT01960842|3009884|Superiority or Other||Mean Difference (Net)|-1.5|||=|0|2-Sided|95.0|-7.3|4.2|||One-sample t-test, 2-sided|||Social Support Domain analysis.|
1637702|NCT01960842|3009884|Superiority or Other||Mean Difference (Net)|-7.5|||=|0|2-Sided|95.0|-15.6|0.6|||One-sample t-test, 2-sided|||Stigma Domain analysis.|
1637703|NCT01960842|3009884|Superiority or Other||Mean Difference (Net)|-6.5|||=|0|2-Sided|95.0|-13.3|0.3|||One-sample t-test, 2-sided|||Emotional Well-Being Domain analysis.|
1637704|NCT01960842|3009884|Superiority or Other||Mean Difference (Net)|-19.2|||<|0.001|2-Sided|95.0|-27.8|-10.6|||One-sample t-test, 2-sided|||Mobility Domain analysis.|
1637705|NCT01960842|3009885|Superiority or Other||Mean Difference (Net)|-1.0|||=|0|2-Sided|95.0|-1.9|-0.09|||One-sample t-test, 2-sided||||
1637706|NCT01960842|3009886|Superiority or Other||Mean Difference (Net)|-2.1|||=|0|2-Sided|95.0|-5.3|1.1|||One-sample t-test, 2-sided||||
1637707|NCT01960842|3009887|Superiority or Other||Mean Difference (Net)|-1.8|||=|0|2-Sided|95.0|-4.0|0.4|||One-sample t-test, 2-sided||||
1637708|NCT01960842|3009888|Superiority or Other||Mean change from score = 4|-2.0|Standard Deviation|0.94|<|0.001|2-Sided||||||Wilcoxon signed-rank test|||The p-value is based on a one-sample Wilcoxon signed-rank test with the hypothesis of no change (score = 4).|
1637709|NCT01960842|3009889|Superiority or Other||Mean change from score = 4|-2.1|Standard Deviation|0.77|<|0.001|2-Sided||||||Wilcoxon signed-rank test|||The p-value is based on a one-sample Wilcoxon signed-rank test with the hypothesis of no change (score = 4).|
1637710|NCT01960842|3009890|Superiority or Other||Mean Difference (Net)|-12.0|||<|0.001|2-Sided|95.0|-16.3|-7.7|||One-sample t-test, 2-sided||||
1637711|NCT01960842|3009891|Superiority or Other||Mean Difference (Net)|5.58|||<|0.001|2-Sided|95.0|4.21|6.95|||One-sample t-test, 2-sided||||
1637712|NCT01960842|3009892|Superiority or Other||Mean Difference (Net)|-4.64|||<|0.001|2-Sided|95.0|-5.78|-3.5|||One-sample t-test, 2-sided||||
1637713|NCT01960530|3009912|Superiority or Other||Mean Difference (Final Values)|89.96|||||2-Sided|90.0|81.72|99.04|||||||
1637714|NCT01960530|3009912|Superiority or Other||Mean Difference (Final Values)|86.99|||||2-Sided|90.0|79.23|95.52|||||||
1637715|NCT01960530|3009917|Non-Inferiority or Equivalence|To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.|Geometric LSmean ratio|106.83|||||2-Sided|90.0|96.92|117.76|||||||
1637716|NCT01960530|3009917|Non-Inferiority or Equivalence|To investigate the absolute and relative bioavailability of cortisol from oral Infacort®, a 20 mg dose of oral Infacort® was compared to a 20 mg dose of i.v. hydrocortisone and hydrocortisone tablets, respectively (Study Periods 3-5). These investigations were conducted in dexamethasone suppressed healthy subjects. Standard bioavailability limits of 80% to 125% were used.|Geometric LSmean ratio|60.12|||||2-Sided|90.0|54.69|66.1||||||Evaluation of Cmax|
1637717|NCT01960400|3009919|Superiority or Other|||||||0.046||||||interaction group X time|ANOVA||||
1637718|NCT01960400|3009920|Superiority or Other|||||||0.035||||||interaction group X time|ANOVA||||
1637719|NCT01960400|3009921|Superiority or Other|||||||0.049||||||interaction group X time|ANOVA||||
1637720|NCT01960400|3009922|Superiority or Other|||||||0.065||||||"The statistical signifiance level : p<0.05. After treatment (T1) Pain severity p=0.065~Sub-scale:~Present pain p=0.046*~Average pain p=0.381~Most intense pain p=0.064~Least intense pain p=0.142"|ANOVA|To assess the effectiveness of interventions (inter-group differences), a mixed-model ANOVA (time X group interaction) was used.||For the severity of pain, the calculations have revealed that only this pain now had an acceptable statistical power, of 77.1% after treatment (T1).|
1637721|NCT01960348|3009927|Superiority||Least Squares Mean Difference|-7.53|Standard Error of the Mean|2.213||0.0008|2-Sided|95.0|-11.89|-3.16|||Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in COMPASS-31 total score. The model includes baseline COMPASS-31 score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.|
1637722|NCT01960348|3009928|Superiority||Least Squares Mean Difference|115.7|Standard Error of the Mean|16.91|<|1e-07|2-Sided|95.0|82.4|149.0||P=8.832E-11|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in mBMI. The model includes baseline mBMI as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.|
1637723|NCT01960348|3009929|Superiority||Least Squares Mean Difference|0.311|Standard Error of the Mean|0.0415|<|1e-07|2-Sided|95.0|0.23|0.393||P=1.875E-12|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in 10-meter walk test result. The model includes baseline 10-meter walk test result as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.|
1637724|NCT01960348|3009930|Superiority||Least Squares Mean Difference|9.0|Standard Error of the Mean|1.01|<|1e-07|2-Sided|95.0|7.0|10.9||P=4.066E-16|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in R-ODS value. The model includes baseline R-ODS score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.|
1637725|NCT01960348|3009931|Superiority||Least Squares Mean Difference|-17.87|Standard Error of the Mean|2.254|<|1e-07|2-Sided|95.0|-22.32|-13.43||P=1.404E-13|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in NIS-W. The model includes baseline NIS-W score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.|
1637726|NCT01960348|3009932|Superiority||Least Squares Mean Difference|-21.1|Standard Error of the Mean|3.1|<|1e-07|2-Sided|95.0|-27.2|-15.0||P=1.103E-10|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in Norfolk QOL-DN total score. The model includes baseline Norfolk QOL-DN score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, baseline NIS, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.|
1637793|NCT01958671|3010165|Superiority or Other||Difference in percentage|-2.6|||||2-Sided|95.0|-8.2|2.7|||||Based on Miettinen & Nurminen method.||
1637727|NCT01960348|3009933|Superiority||Least Squares Mean Difference|-33.99|Standard Error of the Mean|2.974|<|1e-07|2-Sided|95.0|-39.86|-28.13||P=9.262E-24|Mixed-effect Model Repeated Measures|||In the mixed-effect model repeated measures (MMRM) model, the outcome variable is change from baseline in mNIS+7. The model includes baseline mNIS+7 score as covariate and fixed effect terms including treatment group, visit, treatment-by-visit interaction, genotype, age at hATTR symptom onset, previous tetramer stabilizer use and region.|
1637728|NCT01960114|3009944|Superiority or Other|||||||0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Used row-mean scores based on Cochran-Mantel-Haenszel test was stratified by baseline categorical pain score.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1637729|NCT01960114|3009945|Superiority or Other||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 12 hours, but did not use rescue therapy, were censored at the time of withdrawal. Subjects not rescuing during the 12-hour study period had their time to rescue set to 12 hours and were censored.|
1637730|NCT01960114|3009946|Superiority or Other||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1637731|NCT01960114|3009947|Superiority or Other||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1637732|NCT01960114|3009948|Superiority or Other||Least Squares Mean Difference|25.241|Standard Error of the Mean|2.8344|<|0.001|2-Sided|95.0|19.669|30.813||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical score were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1637733|NCT01959932|3009970|Superiority or Other (legacy)||Geometric LS Mean Ratio|23.45|||<|0.001|2-Sided|95.0|22.0|24.99||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on COHb levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."|
1637734|NCT01959932|3009971|Superiority or Other (legacy)||Geometric LS Mean Ratio|5.99|||<|0.001|2-Sided|95.0|5.21|6.87||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on S-PMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."|
1637735|NCT01959932|3009972|Superiority or Other (legacy)||Geometric LS mean ratio|41.63|||<|0.001|2-Sided|95.0|37.75|45.91||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on 3-HPMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."|
1637736|NCT01959932|3009973|Superiority or Other (legacy)||Geometric LS Mean Ratio|8.38|||<|0.001|2-Sided|95.0|6.89|10.2||The primary endpoints were tested using a multiple testing procedure to preserve the overall alpha level by simultaneously testing the endpoints using a closed procedure with each test performed at an alpha level of 2.5% one sided.|ANCOVA|ANCOVA model on MHBMA levels with product, sex, cigarette consumption, and baseline value as covariates.|LS mean ratio THS 2.2:CC|"The hypothesis to be tested is that the geometric mean level on Day 5 of the biomarker of exposure for THS 2.2 is lower relative to CC.~Analysis of the BoExp was conducted on the natural log scale in order to test the following hypothesis (one sided test with 2.5% type I error probability):~Null hypothesis (H0): m1≥m2~Alternative hypothesis (H1): m1<m2 Where m1 and m2 are the geometric means of the BoExp levels on Day 5 for THS 2.2 and CC respectively."|
1637737|NCT01959919|3009976|Superiority or Other||Median Difference (Final Values)|-3.445||||0.001|||||||Wilcoxon Signed Ranks Test|||Comparison between risk associated with clotting factor treatment score at Final Visit Month 8 and baseline visit|
1637738|NCT01959919|3009977|Superiority or Other||Median Difference (Final Values)|-3.98||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between impact of clotting factor treatment score at Final Visit Month 8 and baseline visit|
1637739|NCT01959919|3009978|Superiority or Other||Median Difference (Final Values)|-3.789||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between burden of clotting factor treatment score at Final Visit Month 8 and baseline visit|
1637740|NCT01959919|3009979|Superiority or Other||Mean Difference (Final Values)|4.572|Standard Error of the Mean|0.584||0|2-Sided|95.0|3.411|5.733|||t-test, 2 sided|||Comparison between time for reconstructing the drug at Final visit (Month 8) and baseline visit|
1637794|NCT01958671|3010165|Superiority or Other||Difference in percentage|-2.0|||||2-Sided|95.0|-7.7|3.3|||||Based on Miettinen & Nurminen method.||
1637741|NCT01959919|3009980|Superiority or Other||Mean Difference (Final Values)|-4.907||||0|||||||Wilcoxon Signed Ranks Test|||Comparison between ease of using clotting factor treatment score at Final visit (Month 8) and baseline visit|
1637742|NCT01959841|3009990|Non-Inferiority|Wherein the non-inferiority margin was set at 10%. If the one-sided P-value was less than 0.025 between the ASP2151(200mg) once daily and the valaciclovir 1000 mg three times daily, non-inferiority of ASP2151 to valaciclovir was assumed.||||||0.0688|||||||Modified Farrington–Manning test|||The analysis was performed in the ASP2151(200 mg) once daily only when non-inferiority of the ASP2151(400 mg) 0nce daily to valaciclovir 1000 mg three times daily was assumed.|
1637743|NCT01959841|3009990|Non-Inferiority|Wherein the non-inferiority margin was set at 10%. If the one-sided P-value was less than 0.025 between the ASP2151(400mg) once daily and the valaciclovir 1000 mg three times daily, non-inferiority of ASP2151 to valaciclovir was assumed.||||||2.41e-06|||||||Modified Farrington–Manning test|||The non-inferiority of each ASP2151 dose level versus valaciclovir was assessed stepwise using a closed testing procedure.First step analysis was performed in the ASP2151(400mg) once daily.|
1637744|NCT01959607|3009999|Other||Geometric LS Mean Ratio|96.34|||||2-Sided|95.0|85.1|109.07|||||LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for AUC(0-last), therefore, there was no statistical hypothesis to be tested for this objective.|
1637745|NCT01959607|3010000|Other||Geometric LS Mean Ratio|103.5|||||2-Sided|95.0|84.94|126.11|||||LS mean ratio (THS 2.2 - Group 1:CC - Group 1)|The objective of this study was to determine the point estimate and precision of the nicotine bioavailability (ratio of THS 2.2:CC) for Cmax, therefore, there was no statistical hypothesis to be tested for this objective.|
1637746|NCT01959581|3010001|Superiority or Other||||||<|0.05|||||||ANOVA|||Repeated measures ANOVA|
1637747|NCT01959542|3010002|Other||Pearson’s product-moment correlation|-0.62||||0.03|2-Sided|95.0|-0.62|-0.15|||Pearson’s product-moment correlation|Pearson's product moment correlation|||
1637748|NCT01959542|3010003|Other|Pearson's product-moment correlation|Pearson’s product-moment correlation|-0.53||||0.09|2-Sided|95.0|-86.0|0.1|||Pearson’s product-moment correlation||||
1637749|NCT01959529|3010005|Superiority||Odds Ratio (OR)|0.729|||<|0.001|2-Sided|95.0|0.6|0.866||p-value: Refers to one-sided test of OR >= 1.0 (against Ha: OR<1.0)|Regression, Logistic|The model was logistic regression with log-link function.The model included treatment (IDeg vs IGlar) as a fixed factor and was fitted using the FAS||Superiority of IDeg to IGlar was considered confirmed if the upper limit of the two-sided 95% confidence interval for the odds ratio (OR) was below 1.0 or equivalent if the p-value for the one-sided test of H0: OR ≥1.0 against Ha: OR<1.0, was less than 2.5%.|
1637750|NCT01959529|3010006|Superiority||Rate ratio|0.601|||<|0.001|2-Sided|95.0|0.476|0.759||p-value : Refers to one-sided test of RR >= 1.0 (against Ha: RR<1.0)|Negative binomial regression|The model included treatment (IDeg vs IGlar) as a fixed factor and was fitted using the FAS.||Superiority was considered confirmed if the upper limit of the two-sided 95% confidence interval for the rate ratio (RR) was below 1.0 or equivalent if the p-value for the one-sided test of H0: RR ≥1.0 against Ha: RR <1.0, was less than 2.5%|
1637751|NCT01959529|3010007|Non-Inferiority|Non-inferiority of IDeg to IGlar was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was below 1.3 or equivalent if the p-value for the one-sided test of null hypothesis (H0): HR≥1.3 against the alternative hypothesis (Ha): HR<1.3 was less than 2.5%.|Hazard Ratio (HR)|0.908|||<|0.001|2-Sided|95.0|0.781|1.055||p value : Refers to one-sided test of HR >= 1.3 (against Ha: HR<1.3).|Regression, Cox|||The hazard ratio (HR) (IDeg vs IGlar) was based on Cox regression with investigational medicinal product as only factor for primary analysis.|
1637752|NCT01959516|3010008|Superiority or Other|||||||0.1439|||||||Mixed Models Analysis||||
1637753|NCT01959516|3010009|Superiority or Other|||||||0.025|||||||Mixed Models Analysis||||
1637754|NCT01959503|3010015|Superiority or Other||Odds Ratio (OR)|7.69|||<|0.0001|2-Sided|95.0|3.27|18.11|||Regression, Logistic||||
1637755|NCT01959503|3010016|Superiority or Other||Odds Ratio (OR)|9.0|||<|0.0001|2-Sided|95.0|4.07|19.89|||Regression, Logistic||||
1637756|NCT01959503|3010017|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank-Sum Test||||
1637757|NCT01959139|3010098|Superiority||Hazard Ratio (HR)|1.74||||0.01|2-Sided|95.0|1.14|2.66|||Regression, Cox||||
1637758|NCT01959139|3010099|Superiority||Hazard Ratio (HR)|2.07|||<|0.01|2-Sided|95.0|1.28|3.34|||Regression, Cox||||
1637759|NCT01958918|3010133|Superiority|||||||0.185|||||||ANOVA||||
1637760|NCT01958788|3010149|Superiority or Other||Cohen's d effect size|-0.55|||||2-Sided|||||||||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up|
1637761|NCT01958788|3010149|Superiority or Other||Cohen's d effect size|2.15|||||2-Sided|||||||||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up|
1637762|NCT01958788|3010149|Superiority or Other||Cohen's d effect size|2.08|||||2-Sided|||||||||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment|
1637763|NCT01958788|3010150|Superiority or Other||Cohen's d effect size|-0.56|||||2-Sided|||||||||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up|
1637764|NCT01958788|3010150|Superiority or Other||Cohen's d effect size|1.47|||||2-Sided|||||||||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up|
1637765|NCT01958788|3010150|Superiority or Other||Cohen's d effect size|1.64|||||2-Sided|||||||||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment|
1637766|NCT01958788|3010151|Superiority or Other||Cohen's d effect size|-0.7|||||2-Sided|||||||||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up|
1637795|NCT01958671|3010166|Superiority or Other||Difference in percentage|-4.2|||||2-Sided|95.0|-14.8|6.6|||||Based on Miettinen & Nurminen method.||
1637767|NCT01958788|3010151|Superiority or Other||Cohen's d effect size|1.65|||||2-Sided|||||||||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up|
1637768|NCT01958788|3010151|Superiority or Other||Cohen's d effect size|1.41|||||2-Sided|||||||||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment|
1637769|NCT01958788|3010152|Superiority or Other||Cohen's d effect size|-0.18|||||2-Sided|||||||||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up|
1637770|NCT01958788|3010152|Superiority or Other||Cohen's d effect size|1.06|||||2-Sided|||||||||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up|
1637771|NCT01958788|3010152|Superiority or Other||Cohen's d effect size|1.13|||||2-Sided|||||||||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment|
1637772|NCT01958788|3010153|Superiority or Other||Cohen's d effect size|0.07|||||2-Sided|||||||||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up|
1637773|NCT01958788|3010153|Superiority or Other||Cohen's d effect size|1.66|||||2-Sided|||||||||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up|
1637774|NCT01958788|3010153|Superiority or Other||Cohen's d effect size|1.72|||||2-Sided|||||||||Pre-posttreatment follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment follow-up|
1637775|NCT01958788|3010154|Superiority or Other||Cohen's d effect size|-0.15|||||2-Sided|||||||||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up|
1637776|NCT01958788|3010154|Superiority or Other||Cohen's d effect size|1.29|||||2-Sided|||||||||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up|
1637777|NCT01958788|3010154|Superiority or Other||Cohen's d effect size|1.32|||||2-Sided|||||||||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment|
1637778|NCT01958788|3010155|Superiority or Other||Cohen's d effect size|0.37|||||2-Sided|||||||||Posttreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from posttreatment to 6-month follow-up|
1637779|NCT01958788|3010155|Superiority or Other||Cohen's d effect size|1.34|||||2-Sided|||||||||Pretreatment to 6-month follow-up effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to 6-month follow-up|
1637780|NCT01958788|3010155|Superiority or Other||Cohen's d effect size|2.06|||||2-Sided|||||||||Pre-posttreatment effect size estimation using Cohen's d: a calculation of the relative magnitude of the effect from pretreatment to posttreatment|
1637781|NCT01958671|3010156|Superiority or Other||Difference in least squares means|-0.37||||0.669|2-Sided|95.0|-2.09|1.35||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.|||
1637782|NCT01958671|3010156|Superiority or Other||Odds Ratio (OR)|-1.8||||0.039|2-Sided|95.0|-3.51|-0.09||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.|||
1637783|NCT01958671|3010158|Superiority or Other||Difference in least squares means|-1.71||||0.213|2-Sided|95.0|-4.4|0.98|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.|||
1637784|NCT01958671|3010158|Superiority or Other||Difference in least squares means|-3.31||||0.015|2-Sided|95.0|-5.98|-0.65||Nominal p-value|Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.|||
1637785|NCT01958671|3010160|Superiority or Other||Difference in least squares means|-67.33|||<|0.001|2-Sided|95.0|-81.73|-52.93|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.|||
1637786|NCT01958671|3010160|Superiority or Other||Difference in least squares means|-69.03|||<|0.001|2-Sided|95.0|-83.24|-54.83|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.|||
1637787|NCT01958671|3010162|Superiority or Other||Odds Ratio (OR)|6.77|||<|0.001|2-Sided|95.0|3.46|13.24|||Regression, Logistic|Fixed effects for treatment, prior antihyperglycemic medication, covariates for baseline A1C and baseline|||
1637788|NCT01958671|3010162|Superiority or Other||Odds Ratio (OR)|3.59|||<|0.001|2-Sided|95.0|1.85|6.95|||Regression, Logistic|Fixed effects for treatment, prior antihyperglycemic medication, covariates for baseline A1C and baseline eGFR.|||
1637789|NCT01958671|3010163|Superiority or Other||Difference in least squares means|-2.16|||<|0.001|2-Sided|95.0|-2.98|-1.34|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.|||
1637790|NCT01958671|3010163|Superiority or Other||Difference in least squares means|-1.76|||<|0.001|2-Sided|95.0|-2.57|-0.95|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.|||
1637791|NCT01958671|3010164|Superiority or Other||Difference in least squares means|-44.01|||<|0.001|2-Sided|95.0|-52.28|-35.74|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.|||
1637792|NCT01958671|3010164|Superiority or Other||Difference in least squares means|-34.53|||<|0.001|2-Sided|95.0|-42.76|-26.29|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.|||
1637796|NCT01958671|3010166|Superiority or Other||Difference in percentage|-2.6|||||2-Sided|95.0|-13.1|8.1|||||Based on Miettinen & Nurminen method.||
1637797|NCT01958671|3010167|Superiority or Other||Difference in least squares means|-1.16|||<|0.001|2-Sided|95.0|-1.39|-0.93|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.|||
1637798|NCT01958671|3010167|Superiority or Other||Difference in least squares means|-0.99|||<|0.001|2-Sided|95.0|-1.22|-0.76|||Constrained longitudinal data analysis|Fixed effects for treatment, time, prior anti-hyperglycemic medication, baseline eGFR and the interaction of time by treatment.|||
1637799|NCT01958437|3010209|Superiority|||||||0.599|||||||ANCOVA||||
1637800|NCT01958437|3010209|Superiority|||||||0.497|||||||ANCOVA|||Repeated Measures ANCOVA (covarying stimulation order)|
1637801|NCT01958437|3010210|Superiority|||||||0.046|||||||ANCOVA|Main effect of session using repeated measures ANCOVA covarying stimulation order|||
1637802|NCT01958437|3010210|Superiority||||||<|0.001|||||||ANCOVA|Main effect of session using repeated measures ANCOVA covarying stimulation order|||
1637803|NCT01958437|3010211|Superiority||||||<|0.001|||||||ANCOVA||||
1637804|NCT01958437|3010211|Superiority||||||<|0.27|||||||ANCOVA|Main effect of stimulation covarying session order||Change between active and sham tDCS sessions for allocentric blocks|
1637805|NCT01958437|3010212|Superiority|||||||0.063|||||||ANCOVA|||RM ANCOVA (covarying order) for MCI group|
1637806|NCT01958437|3010212|Superiority|||||||0.048|||||||ANCOVA|||RM ANCOVA (covarying order) for cognitively intact groups|
1637807|NCT01958164|3010268|Superiority or Other||Mean Difference (Net)|66.7|||||2-Sided|95.0|20.7|90.3|||||Difference calculated as actilyse minus saline solution||
1637808|NCT01958164|3010269|Superiority or Other||Mean Difference (Net)|73.3|||||2-Sided|95.0|23.3|89.3|||||Difference calculated as actilyse minus saline solution||
1637809|NCT01958060|3010280|Superiority or Other||Slope|1.5629|Standard Error of the Mean|0.1056|||2-Sided|95.0|1.3426|1.7833|||||Dose proportionality was explored using the linear regression model.The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.Standard error of the mean is actually the standard error of the slope.|This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for AUClast was analysed.|
1637810|NCT01958060|3010282|Superiority or Other||Slope|1.0604|Standard Error of the Mean|0.0337|||2-Sided|95.0|0.9901|1.1308|||||Dose proportionality was explored using linear regression model (ANOVA).The perfect dose proportionality would correspond to a slope β of 1.PK endpoints on the log-transformed scale.Standard error (SE) of the mean is actually the SE of the slope.|This was non confirmatory testing (Single dose). Dose proportionality of BI 1034020 following iv administration of single rising doses of 5 mg, 10 mg, 20 mg and 50 mg for Cmax was analysed.|
1637811|NCT01958021|3010290|Superiority or Other (legacy)|||||||0.000155|||||||Cochran-Mantel-Haenszel||||
1637812|NCT01958021|3010291|Superiority or Other (legacy)||Hazard Ratio (HR)|0.556||||3.29e-06|2-Sided|95.0|0.429|0.72|||Log Rank||||
1637813|NCT01958008|3010296|Superiority or Other||Slope|1.2139|Standard Error of the Mean|0.081|||2-Sided|95.0|1.0519|1.3759||||||Dose proportionality was analysed over the dose range 10 to 50 mg for plasma PK parameters based on a power model|
1637814|NCT01958008|3010297|Superiority or Other||Slope|1.2674|Standard Error of the Mean|0.1019|||2-Sided|95.0|1.0636|1.4713||||||Dose proportionality was analysed over the dose range 10 to 50 mg for plasma PK parameters based on a power model|
1637815|NCT01957865|3010301|Superiority or Other||||||<|0.05|||||||Fisher's exact test|||HIV RNA suppression (<100 copies/ml) was compared among study arms by Fisher’s exact test.|
1637816|NCT01957865|3010302|Superiority or Other||||||<|0.05|||||||Linear and Poisson regressions|||In an intention-to-treat analysis, percentage doses taken each month were compared by linear generalized estimating equations (GEEs); more than 48-h and more than 96-h lapses in dosingwere compared by Poisson GEE regression.|
1637817|NCT01957787|3010314|Other|||||||0.41||||||Estimates of the log odds and Wald standard error from a random effects logistic regression model were combined across imputed datasets for reference.|Random effects logistic regression model|||The null hypothesis was tested comparing the lower bound of the Wald 97.5% 1-sided confidence interval for the estimated rate of local tumor control to the performance goal of 84.0%. If the lower bound was greater than 84.0%, the null hypothesis was rejected and the endpoint was considered met.|
1637818|NCT01957215|3010368|Superiority or Other||Adjusted Mean Difference|0.72||||0.0201||95.0|0.1134|1.3199||P- value was obtained from ANCOVA model with treatment and site as fixed effects and NRS Baseline value as a covariate|ANCOVA||ADJ DIFF is the Treatment difference defined as the Adjusted Mean of 0.35% Indomethacin Patches minus Adjusted Mean of Placebo Patches||
1637819|NCT01957202|3010369|Superiority or Other||Mean Difference (Final Values)|0.14||||0.3807|2-Sided|95.0|-0.175|0.456|||Mixed Model ANOVA||||
1637820|NCT01957202|3010369|Superiority or Other||Mean Difference (Final Values)|-0.775|||<|0.0001|2-Sided|95.0|-1.123|-0.428|||Mixed Model ANOVA||||
1637821|NCT01957202|3010369|Superiority or Other||Mean Difference (Final Values)|-0.56|||<|0.0035|2-Sided|95.0|-0.934|-0.187|||Mixed Model ANOVA||||
1637822|NCT01957202|3010369|Superiority or Other||Mean Difference (Final Values)|-0.701|||<|0.0004|2-Sided|95.0|-1.08|-0.322|||Mixed Model ANOVA||||
1637823|NCT01957202|3010369|Superiority or Other||Mean Difference (Final Values)|-0.075|||<|0.6177|2-Sided|95.0|-0.37|0.221|||Mixed Model ANOVA||||
1637824|NCT01957202|3010369|Superiority or Other||Mean Difference (Final Values)|-0.215|||<|0.1502|2-Sided|95.0|-0.509|0.079|||Mixed Model ANOVA||||
1637825|NCT01957202|3010370|Superiority or Other||Mean Difference (Final Values)|0.361||||0.0478|2-Sided|95.0|0.004|0.719|||Mixed Model ANOVA||||
1637826|NCT01957202|3010370|Superiority or Other||Mean Difference (Final Values)|-0.349||||0.0793|2-Sided|95.0|-0.739|0.041|||Mixed Model ANOVA||||
1637827|NCT01957202|3010370|Superiority or Other||Mean Difference (Final Values)|-0.175||||0.4049|2-Sided|95.0|-0.588|0.239|||Mixed Model ANOVA||||
1637828|NCT01957202|3010370|Superiority or Other||Mean Difference (Final Values)|-0.536||||0.0118|2-Sided|95.0|-0.952|-0.12|||Mixed Model ANOVA||||
1637829|NCT01957202|3010370|Superiority or Other||Mean Difference (Final Values)|0.187||||0.2725|2-Sided|95.0|-0.149|0.523|||Mixed Model ANOVA||||
1637830|NCT01957202|3010370|Superiority or Other||Mean Difference (Final Values)|-0.174||||0.3052|2-Sided|95.0|-0.508|0.16|||Mixed Model ANOVA||||
1637831|NCT01957202|3010371|Superiority or Other||Mean Difference (Final Values)|1.684|||<|0.0001|2-Sided|95.0|1.16|2.208|||Mixed Model ANOVA||||
1637832|NCT01957202|3010371|Superiority or Other||Mean Difference (Final Values)|-0.932|||<|0.0016|2-Sided|95.0|-1.506|-0.358|||Mixed Model ANOVA||||
1637833|NCT01957202|3010371|Superiority or Other||Mean Difference (Final Values)|0.432|||<|0.1648|2-Sided|95.0|-0.179|1.042|||Mixed Model ANOVA||||
1637834|NCT01957202|3010371|Superiority or Other||Mean Difference (Final Values)|-1.252|||<|0.0001|2-Sided|95.0|-1.87|-0.635|||Mixed Model ANOVA||||
1637835|NCT01957202|3010371|Superiority or Other||Mean Difference (Final Values)|0.32|||<|0.1975|2-Sided|95.0|-0.169|0.809|||Mixed Model ANOVA||||
1637836|NCT01957202|3010371|Superiority or Other||Mean Difference (Final Values)|-1.364|||<|0.0001|2-Sided|95.0|-1.853|-0.874|||Mixed Model ANOVA||||
1637837|NCT01957202|3010372|Superiority or Other||Mean Difference (Final Values)|-0.311||||0.3699|2-Sided|95.0|-0.994|0.372|||Mixed Model ANOVA||||
1637838|NCT01957202|3010372|Superiority or Other||Mean Difference (Final Values)|-4.097|||<|0.0001|2-Sided|95.0|-4.857|-3.337|||Mixed Model ANOVA||||
1637839|NCT01957202|3010372|Superiority or Other||Mean Difference (Final Values)|-1.842|||<|0.0001|2-Sided|95.0|-2.654|-1.029|||Mixed Model ANOVA||||
1637840|NCT01957202|3010372|Superiority or Other||Mean Difference (Final Values)|-1.531|||<|0.0003|2-Sided|95.0|-2.342|-0.719|||Mixed Model ANOVA||||
1637841|NCT01957202|3010372|Superiority or Other||Mean Difference (Final Values)|-2.566|||<|0.0001|2-Sided|95.0|-3.208|-1.925|||Mixed Model ANOVA||||
1637842|NCT01957202|3010372|Superiority or Other||Mean Difference (Final Values)|-2.255|||<|0.0001|2-Sided|95.0|-2.895|-1.616|||Mixed Model ANOVA||||
1637843|NCT01957163|3010373|Superiority or Other||Least squared mean difference|0.14|||<|0.001|2-Sided|95.0|0.106|0.175|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)|||
1637844|NCT01957163|3010373|Superiority or Other||Least squared mean difference|0.153|||<|0.001|2-Sided|95.0|0.118|0.187|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)|||
1637845|NCT01957163|3010374|Superiority or Other||Least squared mean difference|0.128|||<|0.001|2-Sided|95.0|0.098|0.159|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)|||
1637846|NCT01957163|3010374|Superiority or Other||Least squared mean difference|0.124|||<|0.001|2-Sided|95.0|0.093|0.154|||Mixed Model Repeated Measure|Restricted maximum likelihood (REM) – based repeated measure approach (MMRM)|||
1637847|NCT01957150|3010375|Other||Percentage Change from Baseline|-0.51|||||2-Sided|95.0|-1.11|0.1|||||Overall week||
1637848|NCT01957150|3010376|Other||Percentage Change from Baseline|-0.05|||||2-Sided|95.0|-0.87|0.78|||||Overall Weeks for female||
1637849|NCT01957150|3010377|Other||Percentage Change from Baseline|-1.02|||||2-Sided|95.0|-1.9|-0.13|||||Overall Weeks for Male||
1637850|NCT01957150|3010378|Non-Inferiority|Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.4|||||2-Sided|95.0|-1.16|0.36|||||Overall Weeks for female||
1637851|NCT01957150|3010379|Non-Inferiority|Non-inferiority was demonstrated if the lower limit of 95% CI for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.47|||||2-Sided|95.0|-1.17|0.24|||||Overall Weeks for Male||
1637852|NCT01957150|3010380|Non-Inferiority|Non-inferiority was demonstrated if the lower limit of 95 % confidence interval (CI) for the overall treatment difference change from Baseline between FF/VI and VI was greater than -1 % year|Percentage Change from Baseline|-0.46|||||2-Sided|95.0|-0.97|0.06|||||Treatment comparison for overall weeks||
1637853|NCT01957137|3010387|Superiority or Other|||||||0.8874|||||||Mixed Models Analysis|The final model included cycling and period.|||
1637854|NCT01957137|3010388|Superiority or Other|||||||0.2396|||||||Mixed Models Analysis|The final model included cycling and period.|||
1637855|NCT01957137|3010389|Superiority or Other|||||||0.3773|||||||Mixed Models Analysis|The final model included cycling, period and the interaction between cycling and period.|||
1637856|NCT01957085|3010392|Superiority or Other (legacy)||||||>|0.05|||||||Chi-squared||||
1637857|NCT01957085|3010394|Superiority or Other (legacy)||||||>|0.05|||||||Chi-squared||||
1637858|NCT01957085|3010395|Superiority or Other (legacy)||||||>|0.05|||||||Chi-squared||||
1637859|NCT01957085|3010396|Superiority or Other (legacy)||||||=|0||||||Statistical significance was set at .05 to determine statistical significance.|Chi-squared||||
1637860|NCT01956240|3010412|Superiority or Other||Median Difference (Final Values)|5.0|||>|0.05|2-Sided|95.0|||||ANOVA|Separate 2-way repeated measures ANOVAs were used to test for interactions of angle x evaluation (1,2,3) and for main effects of evaluation.|||
1637861|NCT01956240|3010413|Superiority or Other||Median Difference (Final Values)|0.51|Standard Deviation|1.9|<|0.05|2-Sided|95.0|||||ANOVA|A 1-way repeated measures ANOVA was used to assess for possible differences among evaluations in each group separately for pectoralis minor length.|||
1637862|NCT01956110|3010427|Other|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.||||||0.39||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Late OHSS (moderate/severe)|
1637863|NCT01956110|3010427|Other|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.||||||0.32||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Late OHSS (any grade)|
1637936|NCT01954927|3010638|Superiority|||||||0.73|||||||Wilcoxon (Mann-Whitney)||||
1637864|NCT01956110|3010433|Equivalence|Treatment groups were compared using a chi-square test.|||||=|0|||||||Chi-squared|||Treatment comparison: Investigator-requested gonadotropin dose adjustments|
1637865|NCT01956110|3010434|Equivalence|Treatment groups were compared using the van Elteren test adjusted for age (<35, 35-37, and 38-40 years).|||||=|0|||||||van Elteren|||Treatment comparison: Number of stimulation days|
1637866|NCT01956110|3010435|Equivalence|Treatment groups were compared using the van Elteren test adjusted for age (<35, 35-37, and 38-40 years).|||||<|0.001|||||||van Elteren|||Treatment comparison: Total gonadotropin dose|
1637867|NCT01956110|3010436|Equivalence|Treatment groups were compared using the van Elteren test adjusted for age (<35, 35-37, and 38-40 years).|||||=|0|||||||van Elteren|||Treatment comparison: Good-quality blastocysts|
1637868|NCT01956110|3010436|Equivalence|Treatment groups were compared using the van Elteren test adjusted for age (<35, 35-37, and 38-40 years).|||||=|0|||||||van Elteren|||Treatment comparison: Number of blastocysts|
1637869|NCT01956110|3010437|Equivalence|Treatment groups were compared using the van Elteren test adjusted for age (<35, 35-37, and 38-40 years).|||||=|0|||||||van Elteren|||Treatment comparison: Good quality embryos|
1637870|NCT01956110|3010437|Equivalence|Treatment groups were compared using the van Elteren test adjusted for age (<35, 35-37, and 38-40 years).|||||=|0|||||||van Elteren|||Treatment comparison: Number of embryos|
1637871|NCT01956110|3010438|Equivalence|Treatment groups were compared using the van Elteren test adjusted for age (<35, 35-37, and 38-40 years).||||||0.53|||||||van Elteren|||Treatment comparison: Fertilisation rate|
1637872|NCT01956110|3010439|Equivalence|Treatment groups were compared using the van Elteren test adjusted for age (<35, 35-37, and 38-40 years).|||||=|0|||||||van Elteren|||Treatment comparison: Number of metaphase II oocytes|
1637873|NCT01956110|3010440|Other|"A logistic regression model was fitted to the data including AMH, log(AMH)^2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)^2 in the linear predictor.~A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)^2 in the linear predictor."|||||=|0||||||Inclusion of treatment provides a better fit to the data|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||The relation between ovarian response potential (AMH at screening) and probability of achieving the targeted response was modelled using logistic regression models.|
1637874|NCT01956110|3010441|Equivalence|Treatment groups were compared using the van Elteren test adjusted for age (<35, 35-37, and 38-40 years).|||||=|0|||||||van Elteren|||Treatment comparison: Number of oocytes retrieved|
1637875|NCT01956110|3010442|Equivalence|Treatment groups were compared using a logistic regression model with treatment and age (<35, 35-37, and 38-40 years) as factors.|Odds Ratio (OR)|0.42||||0.019|2-Sided|95.0|0.2|0.9||P-value corresponds to test for treatment difference.|Likelihood ratio test|||Treatment comparison:Triggering with GnRH agonist|
1637876|NCT01956110|3010442|Equivalence|Treatment groups were compared using a logistic regression model with treatment and age (<35, 35- 37, and 38-40 years) as factors.|Odds Ratio (OR)|1.38|||=|0|2-Sided|95.0|0.74|2.57||P-value corresponds to test for treatment difference.|Likelihood ratio test|||Treatment comparison: Cycle cancelled due to poor response|
1637877|NCT01956110|3010443|Other|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (moderate/severe) and/or preventive interventions|
1637878|NCT01956110|3010443|Other|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (any grade) and/or preventive interventions|
1637879|NCT01956110|3010443|Other|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Preventive interventions|
1637880|NCT01956110|3010443|Other|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (moderate/severe)|
1637881|NCT01956110|3010443|Other|Nested logistic regression models were compared using the likelihood ratio test. The full logistic regression model included treatment as factor, log(AMH) as covariate and the interaction term. The nested model did not include treatment and the interaction term.|||||=|0||||||Inclusion of treatment does not provide a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: Early OHSS (any grade)|
1637882|NCT01956110|3010444|Other|A logistic regression model was fitted to the data including AMH, log(AMH)2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)^2 in the linear predictor. A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)^2 in the linear predictor.|||||=|0||||||Inclusion of treatment provides a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: <4 or >=20 oocytes retrieved|
1637883|NCT01956110|3010444|Other|A logistic regression model was fitted to the data including AMH, log(AMH)^2, treatment group and interactions between treatment group and AMH and treatment group and log(AMH)^2 in the linear predictor. A second logistic regression model (nested within the first model) was fitted including AMH and log(AMH)^2 in the linear predictor.|||||=|0||||||Inclusion of treatment provides a better fit to the data.|Likelihood ratio test|Likelihood ratio test comparing the reduced model including only AMH to the full model including AMH, treatment group and interactions.||Treatment comparison: <4 or >=15 oocytes retrieved|
1637884|NCT01956110|3010445|Non-Inferiority|The lower bound of the 95% CI was well above -8.0% (pre-specified non-inferiority limit for the co-primary endpoints). Thus, the result was supportive of the co-primary endpoint analyses.|Treatment difference|-1.4|||||2-Sided|95.0|-7.0|4.2||||||Treatment groups were compared using a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.|
1637885|NCT01956110|3010446|Non-Inferiority|The lower bound of the 95% CI was well above -8.0% (pre-specified non-inferiority limit for the co-primary endpoints). Thus, the result was supportive of the co-primary endpoint analyses.|Treatment difference|-1.6|||||2-Sided|95.0|-6.7|3.4||||||Treatment groups were compared using a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.|
1637886|NCT01956110|3010447|Non-Inferiority|The lower bound of the 95% CI was well above the pre-specified non-inferiority limit of -8.0%. Thus, non-inferiority of FE 999049 to GONAL-F with regard to ongoing implantation rate was demonstrated.|Treatment difference|-0.6|||||2-Sided|95.0|-6.1|4.8||||||The pre-specified non-inferiority margin was -8.0% (absolute). Non-inferiority was evaluated based on a two-sided 95% CI derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.|
1637887|NCT01956110|3010448|Non-Inferiority|The lower bound of the 95% CI was well above the pre-specified non-inferiority limit of -8.0%. Thus, non-inferiority of FE 999049 to GONAL-F with regard to ongoing pregnancy rate was demonstrated.|Treatment difference|-0.9|||||2-Sided|95.0|-5.9|4.1||||||The pre-specified non-inferiority margin was -8.0% (absolute). Non-inferiority was evaluated based on a two-sided 95% confidence interval (CI) derived based on the asymptotic normal distribution. The treatment comparison was adjusted for age (<35, 35-37 and 38-40 years) by using the Mantel-Haenszel method to combine results across age-strata.|
1637888|NCT01955707|3010518|Superiority or Other||Adjusted mean|3.56||||0.283|2-Sided|90.0|-6.64|13.75|||repeated measures mixed effects model|||Analysis of Barthel Index at Day 90/Final Visit. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.|
1637889|NCT01955707|3010518|Superiority or Other||Adjusted mean|1.21||||0.42|2-Sided|90.0|-8.76|11.19||one-sided p-value|repeated measures mixed effects model|||Analysis of Barthel Index at Day 30. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.|
1637890|NCT01955707|3010518|Superiority or Other||Adjusted mean|0.68||||0.455|2-Sided|90.0|-9.19|10.56||one-sided p-value|repeated measures mixed effects model|||Analysis of Barthel Index at Day 5. The repeated measures mixed effects model is modeling Barthel Index using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, and location of stroke.|
1637891|NCT01955707|3010519|Superiority or Other||Odds Ratio (OR)|1.15||||0.243|2-Sided|90.0|0.71|1.86||One -sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (< median vs >= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of the distribution of mRS scores at Day 90. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (< median vs >= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|
1637892|NCT01955707|3010519|Superiority or Other||Odds Ratio (OR)|1.3||||0.077|2-Sided|90.0|0.8|2.1||One-sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (< median vs >= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of distribution of mRS scores at Day 30. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (< median vs >= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|
1637893|NCT01955707|3010519|Superiority or Other||Odds Ratio (OR)|0.89||||0.564|2-Sided|90.0|0.55|1.45||One sided p-value based on Van Elteren's test, adjusting for baseline DWI volume (< median vs >= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|Van Elteren's test|||Analysis of distribution of mRS scores at Day 5. Odds ratio from a proportional-odds logistic regression model assuming a common odds ratio across all cut points of the mRS score. Covariates include baseline DWI volume (< median vs >= median), treatment time window, location of stroke abnormality (cortical/subcortical), and tPA use (yes/no).|
1637894|NCT01955707|3010520|Superiority or Other||adjusted mean change from baseline|1.93||||0.915|2-Sided|90.0|-0.38|4.25||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 90. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.|
1637895|NCT01955707|3010520|Superiority or Other||adjusted mean change from baseline|3.15||||0.989|2-Sided|90.0|0.89|5.4||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 30. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.|
1637896|NCT01955707|3010520|Superiority or Other||adjusted mean change from baseline|1.71||||0.896|2-Sided|90.0|-0.52|3.94||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at Day 5. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.|
1637897|NCT01955707|3010520|Superiority or Other||adjusted mean change from baseline|-0.25||||0.427|2-Sided|90.0|-2.48|1.98||one-sided p-value|repeated measures mixed effects model|||Analysis of NIHSS score and change from Baseline at 24 hours. The repeated measures mixed effects model is modeling absolute change in NIHSS score relative to baseline and using an autoregressive variance-covariance matrix. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, tPA use, baseline NIHSS score and location of stroke.|
1637898|NCT01955707|3010521|Superiority or Other||ratio of relative growth|0.98||||0.394|2-Sided|90.0|0.84|1.14||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.||
1637899|NCT01955707|3010521|Superiority or Other||Adjusted mean difference (log-scale)|-0.02|||||2-Sided|90.0|-0.18|0.13||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to Day 5 using an autoregressive variance-covariance matrix structure. The model adjusts for for treatment, log baseline DWI volume, treatment time window, and tPA use.|
1637900|NCT01955707|3010522|Superiority or Other||ratio of relative growth|0.98||||0.402|2-Sided|90.0|0.87|1.11||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.||
1637901|NCT01955707|3010522|Superiority or Other||Adjusted mean difference (log-scale)|-0.02|||||2-Sided|90.0|-0.14|0.1||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to 24 hours using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.|
1637902|NCT01955707|3010523|Superiority or Other||ratio of relative growth|1.0||||0.487|2-Sided|90.0|0.89|1.12||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.||
1637903|NCT01955707|3010523|Superiority or Other||Adjusted mean difference (log-scale)|0.0|||||2-Sided|90.0|-0.12|0.11||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to 24 hours using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.|
1637904|NCT01955707|3010524|Superiority or Other||ratio of relative growth|1.05||||0.684|2-Sided|90.0|0.88|1.27||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.||
1637905|NCT01955707|3010524|Superiority or Other||Adjusted mean difference (log-scale)|0.05|||||2-Sided|90.0|-0.13|0.24||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.|
1637906|NCT01955707|3010525|Superiority or Other||ratio of relative growth|1.09||||0.797|2-Sided|90.0|0.92|1.31||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.||
1637907|NCT01955707|3010525|Superiority or Other||adjusted mean difference (log-scale)|0.09|||||2-Sided|90.0|-0.09|0.27||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tPA use.|
1637908|NCT01955707|3010526|Superiority or Other||ratio of relative growth|1.09||||0.779|2-Sided|90.0|0.91|1.3||one-sided p-value|repeated measures mixed effects model||Adjusted mean (log-scale) back-transformed to the original scale as the estimated ratio of natalizumab to placebo. 90% confidence interval (log-scale) back-transformed to the original scale and reflect the interval around the ratio.||
1637909|NCT01955707|3010526|Superiority or Other||adjusted mean difference (log-scale)|0.08|||||2-Sided|90.0|-0.09|0.26||||||Treatment contrasts derived from a repeated measures mixed effects model modeling log relative growth relative to baseline using an autoregressive variance-covariance matrix structure. The model adjusts for treatment, time, treatment by time, log baseline DWI volume, treatment time window, and tissue plasminogen activator (tPA) use.|
1637910|NCT01955382|3010593|Superiority||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1637911|NCT01955161|3010605|Superiority||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.09||1|2-Sided|95.0|-0.34|0.02||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, ADAS-cog total score and either ADCS-ADL23 total score or ADCS CGIC had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.|
1637937|NCT01954927|3010639|Superiority|||||||0.181|||||||Chi-squared||||
1637938|NCT01954927|3010640|Superiority|||||||0.897|||||||Wilcoxon (Mann-Whitney)||||
1637939|NCT01954927|3010641|Superiority|||||||0.227||||||1-sided p-value|z-test Proportion|z-test of proportions without continuity correction|||
1637912|NCT01955161|3010605|Superiority||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.09||1|2-Sided|95.0|-0.15|0.2||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.|
1637913|NCT01955161|3010606|Superiority||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.66||1|2-Sided|95.0|-1.29|1.31||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.|
1637914|NCT01955161|3010606|Superiority||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.66||1|2-Sided|95.0|-1.37|1.21||Corrected for multiplicity according toe the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A positive mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.|
1637915|NCT01955161|3010607|Superiority||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.47||1|2-Sided|95.0|-0.88|0.98||Corrected for multiplicity according to the multiple testing procedure|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine.|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.|
1637916|NCT01955161|3010607|Superiority||Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.47||0.9591|2-Sided|95.0|-0.59|1.26||Corrected for multiplicity|Mixed Models Analysis|Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions|A negative mean difference indicates a treatment effect in favour of idalopirdine|For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.|
1637917|NCT01955083|3010615|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1637918|NCT01955083|3010616|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1637919|NCT01955083|3010617|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1637920|NCT01955083|3010618|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1637921|NCT01955083|3010619|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1637922|NCT01955083|3010620|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1637923|NCT01955083|3010621|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1637924|NCT01955083|3010622|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1637925|NCT01955083|3010623|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1637926|NCT01955083|3010624|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1637927|NCT01955083|3010625|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1637928|NCT01955083|3010626|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1637929|NCT01955083|3010627|Superiority or Other||Mean Difference (Final Values)|17.0|Standard Deviation|16.0|<|0.05|2-Sided|95.0|-14.4|48.4|||Wilcoxon (Mann-Whitney)|||We hypothesized that pillar implant provide a better efficacy in the treatment of snoring than radiofrequency surgery. The sample size was estimated using the primary outcome effects (VAS) in two previously published studies (Friedman 2008; Fang 2004). Using a two-tailed Wilcoxon signed-rank test (normal parent distribution; effect size, 1.0; type I error, 0.05; power, 80%), we got a sample size of 11. For considering a 20% drop-out rate, we needed at least 14 participants.|
1637930|NCT01955005|3010632|Superiority or Other||Table Probability|0.0142||||0.02|2-Sided||||||Fisher's Exact||||
1637931|NCT01955005|3010633|Superiority or Other||Z score|568.5||||0.73|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1637932|NCT01955005|3010634|Superiority or Other||||||<|0.001|||||||Fisher Exact|||This was a 2x2 comparison using Fisher's exact due to low expected cell count. Fisher's exact p<0.001|
1637933|NCT01954927|3010635|Superiority|||||||0.388|||||||Wilcoxon (Mann-Whitney)||||
1637934|NCT01954927|3010636|Superiority|||||||0.739|||||||Wilcoxon (Mann-Whitney)||||
1637935|NCT01954927|3010637|Superiority|||||||0.713|||||||Chi-squared||||
1637940|NCT01954771|3010644|Superiority or Other||Correlation Coefficient|0.801|||<|0.001|2-Sided||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.|
1637941|NCT01954771|3010644|Superiority or Other||Correlation Coefficient|0.479|||<|0.009|2-Sided||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.|
1637942|NCT01954771|3010644|Superiority or Other||Correlation Coefficient|0.533|||<|0.011|2-Sided||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from CGMS measurements.|
1637943|NCT01954771|3010644|Superiority or Other||Correlation Coefficient|0.784|||<|0.001|2-Sided||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.|
1637944|NCT01954771|3010644|Superiority or Other||Correlation coefficient|0.522|||<|0.004|2-Sided||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.|
1637945|NCT01954771|3010644|Superiority or Other||Correlation coefficient|0.726|||<|0.001|2-Sided||||||Correlation analysis|||The correlation study between HbA1c and MBG (mean blood glucose) from SMBG measurements.|
1637946|NCT01954628|3010651|Superiority or Other|||||||0.226|||||||ANOVA|||Missing post-treatment data was imputed using the Last Observation Carried Forward principle.|
1637947|NCT01954628|3010654|Superiority or Other||Least sqaure mean difference|1.083||||0.646|2-Sided|95.0|0.771|1.52|||Negative binomial regression model|Negative binomial regression model with fixed factors treatment, region and time in study as offset.||The number of subjects with at least one COPD exacerbation were summarised by treatment group.|
1637948|NCT01954628|3010655|Superiority or Other||Least sqaure mean difference|-0.34||||0.588|2-Sided|95.0|-1.57|0.89|||ANOVA|||ANOVA model with fixed factors treatment, region and baseline total CAT score as covariate were used. Missing post-treatment data were imputed using the Last Observation Carried Forward principle.|
1637949|NCT01954628|3010656|Superiority or Other||Least sqaure mean difference|23.7||||0.759|2-Sided|95.0|-128.3|175.7||AAC were compared between treatments using an analysis of variance model adjusting for treatment and region as factors and including the baseline score as a covariate.|ANOVA|||Sample size based on area above the daily EXACT score curve (AAC) from Day 1 to Day 29 from subjects with an acute COPD exacerbation, collected over 28 days. Assuming a residual SD of 500 points, a sample size of 200 subjects per arm would be expected to have an 80% power to detect a true treatment difference in the AAC of 140 points over 12-weeks treatment, using a 2-sided test; alpha-level of 0.05.This difference corresponds to a mean daily improvement of 1.67 points on the EXACT symptom score|
1637950|NCT01954251|3010710|Non-Inferiority or Equivalence|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|0.98|||||2-Sided|95.0|0.88|1.09||||||For the Flu B/Massachusetts/2/2012 Yamagata strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.|
1637951|NCT01954251|3010710|Non-Inferiority or Equivalence|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.07|||||2-Sided|95.0|0.95|1.2||||||For the Flu B/Brisbane/60/2008 Victoria strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.|
1637952|NCT01954251|3010710|Non-Inferiority or Equivalence|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.03|||||2-Sided|95.0|0.91|1.17||||||For the Flu A/Texas/50/2012 H3N2 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.|
1637953|NCT01954251|3010710|Non-Inferiority or Equivalence|Comparisons at Day 21 after the FLU-D-QIV dose were performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non inferior compared to the Control group in terms of immunogenicity (for each strain) if the UL of 2-sided 95% CI of the ratio of GMTs between the Control and the GSK1437173A + GSK2321138A (Control/ GSK1437173A + GSK2321138A) group is below 1.5.|Adjusted geometric mean Titer ratio|1.04|||||2-Sided|95.0|0.88|1.22||||||For the Flu A/California/7/2009 H1N1 strain ,an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. GMs of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for this strain.|
1637990|NCT01953354|3010854|Superiority or Other|||||||0.55||||||P-value is testing for a difference in proportions using a Fisher’s exact test.|Fisher Exact||||
1637991|NCT01953354|3010855|Superiority or Other|||||||0.242||||||P-value is testing for a difference in proportions using a Fisher’s exact test.|Fisher Exact||||
1637954|NCT01954251|3010711|Non-Inferiority or Equivalence|Comparison at one month after the last dose of HZ/su was performed between the Control group and GSK1437173A + GSK2321138A group. The GSK1437173A + GSK2321138A group was considered as statistically significant non-inferior compared to the Control group in terms of immunogenicity if the UL of the 2-sided 95% CI of the ratio of GMs between the Control and the Co-Ad group (Control over GSK1437173A + GSK2321138A) was below 1.5.|Adjusted Geometric mean concentration ra|1.08|||||2-Sided|95.0|0.97|1.2||||||Adjusted ratios of Control group over GSK1437173A + GSK2321138A group in anti-gE antibody ELISA concentrations GMCs at one month after last vaccine dose. An Analysis of Covariance (ANCOVA) model was used to analyse post-vaccination log-transformed concentrations of anti-gE. The fixed-effect model included the minimisation variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate.|
1637955|NCT01954121|3010745|Non-Inferiority or Equivalence|The non-inferiority margin for the adjusted difference in seizure free proportion in the LEV minus the seizure free proportion in the CBZ-IR group was set to absolute -20% points.|adjusted difference in proportions|-22.9|||||2-Sided|95.0|-33.1|-12.6||||||The adjusted absolute difference in treatment group seizure-free proportions (referenced as 'Adjusted difference in proportions' in 'Method of Estimation' below) was derived from the adjusted treatment group proportions of seizure-free subjects. The adjusted proportions were derived from a logistic regression model of seizure freedom using treatment and the categories for the number of seizures in the 3-month period prior to Visit 1 (≤2 seizures and >2 seizures) as covariates.|
1637956|NCT01954082|3010760|Superiority||Risk Ratio (RR)|1.04||||0.8133|2-Sided|95.0|0.74|1.48||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR>1 implies that the risk of severe IVH is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence severe IVH.|
1637957|NCT01954082|3010761|Superiority||Risk Ratio (RR)|0.98||||0.7598|2-Sided|95.0|0.83|1.14||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR>1 implies that the risk of Type 2 ROP or more severe ROP is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence of Type 2 ROP or more severe ROP.|
1637958|NCT01954082|3010762|Superiority||Risk Ratio (RR)|1.02||||0.7464|2-Sided|95.0|0.91|1.14||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.||The null hypothesis is there is no treatment effect on the incidence of ROP|
1637959|NCT01954082|3010763|Superiority||Risk Ratio (RR)|1.53||||0.0306|2-Sided|95.0|1.03|2.25||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR>1 implies that the risk of mortality prior to ROP endpoint is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on survival to ROP endpoint.|
1637960|NCT01954082|3010764|Superiority||Risk Ratio (RR)|1.05||||0.3883|2-Sided|95.0|0.94|1.17||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.||The null hypothesis is there is no treatment effect on the incidence of BPD or on mortality due to BDP.|
1637961|NCT01954082|3010765|Superiority||Risk Ratio (RR)|1.03||||0.6599|2-Sided|95.0|0.91|1.16||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson regression|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR>1 implies that the risk of BPD is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the incidence of BPD.|
1637962|NCT01954082|3010766|Superiority||Risk Ratio (RR)|1.41||||0.0095|2-Sided|95.0|1.08|1.83||A-priori threshold for statistical significance at 0.05 was specified.|Robust Poisson|Model adjusted for strata defined by center and gestational age.|In the risk ratio, the numerator represents the Inositol arm and the denominator represents the placebo arm. (RR>1 implies that the risk of mortality and/or severe ROP is greater in the Inositol group compared to the Placebo group).|The null hypothesis is there is no treatment effect on the development of severe ROP and mortality.|
1637963|NCT01953874|3010834|Other|The primary analysis was based on the Wilcoxon-Mann-Whitney test and therefore the power calculation was approximated using the approach of Tang.||||||0.916|||||||Wilcoxon (Mann-Whitney)|||The primary endpoint was a composite measure of global rank order response based on survival time, freedom from CV hospitalization, and improvement in functional capacity measured by percent change in 6MWD from baseline to 6 months. The plan was to randomize up to 215 subjects. However, due to safety issues observed in SERVE-HF, randomization was stopped at 126 subjects.|
1637964|NCT01953601|3010836|Superiority||Difference in Least Squares Mean (LSM)|-1.7||||0.011|2-Sided|97.51|-3.2|-0.2|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.
1637965|NCT01953601|3010836|Superiority||Difference in Least Squares Mean (LSM)|-1.0||||0.096|2-Sided|97.51|-2.4|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.
1637966|NCT01953601|3010837|Superiority||Difference in Least Squares Mean (LSM)|-0.06|||<|0.0001|2-Sided|97.51|-0.07|-0.05|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.
1637967|NCT01953601|3010837|Superiority||Difference in Least Squares Mean (LSM)|-0.05|||<|0.0001|2-Sided|97.51|-0.06|-0.04|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.
1637968|NCT01953601|3010838|Superiority||Difference in Least Squares Mean (LSM)|-0.6||||0.031|2-Sided|97.51|-1.2|0.0|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.
1637969|NCT01953601|3010838|Superiority||Difference in Least Squares Mean (LSM)|-0.4||||0.1133|2-Sided|97.51|-1.0|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.
1637970|NCT01953601|3010839|Superiority||Difference in Least Squares Mean (LSM)|0.0||||0.9392|2-Sided|97.51|-0.2|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.
1637971|NCT01953601|3010839|Superiority||Difference in Least Squares Mean (LSM)|0.0||||0.951|2-Sided|97.51|-0.2|0.2|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.
1637972|NCT01953601|3010840|Superiority||Difference in Least Squares Mean (LSM)|0.3||||0.0824|2-Sided|97.51|-0.1|0.7|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.
1637973|NCT01953601|3010840|Superiority||Difference in Least Squares Mean (LSM)|0.0||||0.9109|2-Sided|97.51|-0.3|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.
1637974|NCT01953601|3010841|Superiority||Hazard Ratio (HR)|1.382||||0.005|2-Sided|97.51|1.067|1.79|||Regression, Cox||HR = Arm B / Arm C||Based on Cox regression model with Efron′s method of tie handling with treatment, background AD treatment (use, no use), sex, APOE4 status (carrier, non-carrier) and baseline use of Vitamin E as categorical covariates and age and baseline MMSE value as continuous covariates.
1637975|NCT01953601|3010841|Superiority||Hazard Ratio (HR)|1.301||||0.0222|2-Sided|97.51|1.005|1.684|||Regression, Cox||HR = Arm A / Arm C||Based on Cox regression model with Efron′s method of tie handling with treatment, background AD treatment (use, no use), sex, APOE4 status (carrier, non-carrier) and baseline use of Vitamin E as categorical covariates and age and baseline MMSE value as continuous covariates.
1637976|NCT01953601|3010842|Other||Difference in % vs Placebo|-2.38|||||2-Sided|95.0|-6.01|0.71|||||Difference in % = Arm B - Arm C||
1637977|NCT01953601|3010842|Other||Difference in % vs Placebo|-2.42|||||2-Sided|95.0|-6.03|0.61|||||Difference in % = Arm A - Arm C||
1637978|NCT01953601|3010843|Other||Difference in % vs Placebo|-10.68|||||2-Sided|95.0|-20.16|-1.04|||||Difference in % = Arm B - Arm C||
1637979|NCT01953601|3010843|Other||Difference in % vs Placebo|-6.79|||||2-Sided|95.0|-16.16|2.68|||||Difference in % = Arm A - Arm C||
1637980|NCT01953601|3010844|Other||Difference in % vs Placebo|5.58|||||2-Sided|95.0|2.35|8.99|||||Difference in % = Arm B - Arm C||
1637981|NCT01953601|3010844|Other||Difference in % vs Placebo|2.08|||||2-Sided|95.0|-0.84|5.1|||||Difference in % = Arm A - Arm C||
1637982|NCT01953601|3010845|Other||Difference in % vs Placebo|5.17|||||2-Sided|95.0|1.33|9.09|||||Difference in % = Arm B - Arm C||
1637983|NCT01953601|3010845|Other||Difference in % vs Placebo|4.32|||||2-Sided|95.0|0.4|8.31|||||Difference in % = Arm A - Arm C||
1637984|NCT01953601|3010847|Superiority||Difference in Least Squares Means (LSM)|0.4||||0.0141|2-Sided|97.51|0.0|0.8|||Longitudinal ANCOVA||Difference in LSM = Arm B - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.
1637985|NCT01953601|3010847|Superiority||Difference in Least Squares Mean (LSM)|0.1||||0.6734|2-Sided|97.51|-0.3|0.4|||Longitudinal ANCOVA||Difference in LSM = Arm A - Arm C||Analysis model includes categorical factors of geographic region, time, treatment, gender, APOE genotype, baseline use of Vitamin E, baseline use of AChEI, and the interaction of time by treatment, with baseline value, the interaction of baseline value and time, the baseline value of MMSE and the baseline value of age included as continuous covariates.
1637986|NCT01953432|3010849|Other||Odds Ratio (OR)|0.96|||||2-Sided||||||||Probability of 0.96 that the odds ratio exceeded 1.00 (OR = 1.03, 95% CI = 1.00-1.07)||
1637987|NCT01953432|3010849|Other||Odds Ratio (OR)|0.75|||||2-Sided||||||||Probability of 0.75 that the OR exceeded 1.00 (OR = 1.01, 95% CI = 0.98-1.05)||
1637988|NCT01953354|3010850|Superiority or Other|||||||0.633||||||P-value is testing for a difference in proportions using a Fisher’s exact test.|Fisher Exact||||
1637989|NCT01953354|3010851|Superiority or Other|||||||0.55||||||P-value is testing for a difference in proportions using a Fisher’s exact test.|Fisher Exact||||
1637992|NCT01953354|3010856|Superiority or Other|||||||1||||||P-value is testing for a difference in proportions using a Fisher’s exact test.|Fisher Exact||||
1637993|NCT01953354|3010857|Superiority or Other|||||||1||||||P-value is testing for a difference in proportions using a Fisher’s exact test.|Fisher Exact||||
1637994|NCT01953328|3010858|Superiority or Other||LS Mean Treatment Difference|-24.35|Standard Error of the Mean|6.22|<|0.001|2-Sided|95.0|-36.7|-11.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1637995|NCT01953328|3010858|Superiority or Other||LS Mean Treatment Difference|-15.05|Standard Error of the Mean|5.37|<|0.001|2-Sided|95.0|-25.72|-4.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1637996|NCT01953328|3010858|Superiority or Other||LS Mean Treatment Difference|-20.81|Standard Error of the Mean|5.78|<|0.001|2-Sided|95.0|-32.29|-9.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1637997|NCT01953328|3010858|Superiority or Other||LS Mean Treatment Difference|-28.42|Standard Error of the Mean|7.08|<|0.001|2-Sided|95.0|-42.48|-14.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1637998|NCT01953328|3010859|Superiority or Other||LS Mean Treatment Difference|-27.16|Standard Error of the Mean|6.12|<|0.001|2-Sided|95.0|-39.31|-15.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1637999|NCT01953328|3010859|Superiority or Other||LS Mean Treatment Difference|-18.09|Standard Error of the Mean|4.69|<|0.001|2-Sided|95.0|-27.4|-8.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638000|NCT01953328|3010859|Superiority or Other||LS Mean Treatment Difference|-22.65|Standard Error of the Mean|5.17|<|0.001|2-Sided|95.0|-32.91|-12.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638001|NCT01953328|3010859|Superiority or Other||LS Mean Treatment Difference|-27.85|Standard Error of the Mean|5.8|<|0.001|2-Sided|95.0|-39.37|-16.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638002|NCT01953328|3010860|Superiority or Other||LS Mean Treatment Difference|10.2|Standard Error of the Mean|2.7||0.001|2-Sided|95.0|4.85|15.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638003|NCT01953328|3010860|Superiority or Other||LS Mean Treatment Difference|16.85|Standard Error of the Mean|3.08|<|0.001|2-Sided|95.0|10.74|22.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638004|NCT01953328|3010860|Superiority or Other||LS Mean Treatment Difference|15.2|Standard Error of the Mean|2.68|<|0.001|2-Sided|95.0|9.87|20.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638005|NCT01953328|3010860|Superiority or Other||LS Mean Treatment Difference|13.46|Standard Error of the Mean|3.06|<|0.001|2-Sided|95.0|7.4|19.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638006|NCT01953328|3010861|Superiority or Other||LS Mean Treatment Difference|9.15|Standard Error of the Mean|2.26||0.001|2-Sided|95.0|4.67|13.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638007|NCT01953328|3010861|Superiority or Other||LS Mean Treatment Difference|15.36|Standard Error of the Mean|2.64|<|0.001|2-Sided|95.0|10.12|20.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638008|NCT01953328|3010861|Superiority or Other||LS Mean Treatment Difference|14.61|Standard Error of the Mean|2.36|<|0.001|2-Sided|95.0|9.93|19.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638009|NCT01953328|3010861|Superiority or Other||LS Mean Treatment Difference|12.33|Standard Error of the Mean|2.49|<|0.001|2-Sided|95.0|7.39|17.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638010|NCT01953328|3010862|Superiority or Other||LS Mean Treatment Difference|-16.92|Standard Error of the Mean|7.24||0.01|2-Sided|95.0|-31.29|-2.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638011|NCT01953328|3010862|Superiority or Other||LS Mean Treatment Difference|-17.17|Standard Error of the Mean|5.53|<|0.001|2-Sided|95.0|-28.15|-6.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638012|NCT01953328|3010862|Superiority or Other||LS Mean Treatment Difference|-19.97|Standard Error of the Mean|5.9|<|0.001|2-Sided|95.0|-31.68|-8.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638013|NCT01953328|3010862|Superiority or Other||LS Mean Treatment Difference|-27.57|Standard Error of the Mean|9.45|<|0.001|2-Sided|95.0|-46.33|-8.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638014|NCT01953328|3010863|Superiority or Other||LS Mean Treatment Difference|-20.72|Standard Error of the Mean|6.78||0.01|2-Sided|95.0|-34.18|-7.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638015|NCT01953328|3010863|Superiority or Other||LS Mean Treatment Difference|-20.01|Standard Error of the Mean|4.83|<|0.001|2-Sided|95.0|-29.59|-10.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638016|NCT01953328|3010863|Superiority or Other||LS Mean Treatment Difference|-21.94|Standard Error of the Mean|5.34|<|0.001|2-Sided|95.0|-32.54|-11.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638017|NCT01953328|3010863|Superiority or Other||LS Mean Treatment Difference|-27.93|Standard Error of the Mean|6.72|<|0.001|2-Sided|95.0|-41.27|-14.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638018|NCT01953328|3010864|Superiority or Other||LS Mean Treatment Difference|-39.97|Standard Error of the Mean|5.29|<|0.001|2-Sided|95.0|-50.46|-29.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638019|NCT01953328|3010864|Superiority or Other||LS Mean Treatment Difference|-52.68|Standard Error of the Mean|5.73|<|0.001|2-Sided|95.0|-64.06|-41.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638020|NCT01953328|3010864|Superiority or Other||LS Mean Treatment Difference|-48.77|Standard Error of the Mean|5.9|<|0.001|2-Sided|95.0|-60.49|-37.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638021|NCT01953328|3010864|Superiority or Other||LS Mean Treatment Difference|-50.07|Standard Error of the Mean|7.64|<|0.001|2-Sided|95.0|-65.25|-34.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638022|NCT01953328|3010865|Superiority or Other||LS Mean Treatment Difference|-43.93|Standard Error of the Mean|4.95|<|0.001|2-Sided|95.0|-53.75|-34.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638023|NCT01953328|3010865|Superiority or Other||LS Mean Treatment Difference|-49.55|Standard Error of the Mean|5.14|<|0.001|2-Sided|95.0|-59.74|-39.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638024|NCT01953328|3010865|Superiority or Other||LS Mean Treatment Difference|-49.08|Standard Error of the Mean|4.94|<|0.001|2-Sided|95.0|-58.89|-39.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638025|NCT01953328|3010865|Superiority or Other||LS Mean Treatment Difference|-51.2|Standard Error of the Mean|6.39|<|0.001|2-Sided|95.0|-63.88|-38.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638026|NCT01953328|3010866|Superiority or Other||Treatment Difference|78.0|||<|0.001|2-Sided|95.0|62.6|86.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).|||
1638027|NCT01953328|3010866|Superiority or Other||Treatment Difference|75.6|||<|0.001|2-Sided|95.0|59.3|85.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).|||
1638028|NCT01953328|3010866|Superiority or Other||Treatment Difference|91.8|||<|0.001|2-Sided|95.0|78.2|96.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).|||
1638029|NCT01953328|3010866|Superiority or Other||Treatment Difference|98.0|||<|0.001|2-Sided|95.0|86.7|99.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).|||
1638030|NCT01953328|3010867|Superiority or Other||Treatment Difference|82.4|||<|0.001|2-Sided|95.0|67.5|90.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).|||
1638031|NCT01953328|3010867|Superiority or Other||Treatment Difference|73.6|||<|0.001|2-Sided|95.0|57.1|83.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).|||
1638032|NCT01953328|3010867|Superiority or Other||Treatment Difference|96.0|||<|0.001|2-Sided|95.0|84.1|98.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).|||
1638033|NCT01953328|3010867|Superiority or Other||Treatment Difference|98.0|||<|0.001|2-Sided|95.0|86.8|99.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).|||
1638034|NCT01953328|3010868|Superiority or Other||LS Mean Treatment Difference|-60.62|Standard Error of the Mean|2.47|<|0.001|2-Sided|95.0|-65.51|-55.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638035|NCT01953328|3010868|Superiority or Other||LS Mean Treatment Difference|-63.97|Standard Error of the Mean|2.75|<|0.001|2-Sided|95.0|-69.44|-58.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638036|NCT01953328|3010868|Superiority or Other||LS Mean Treatment Difference|-62.53|Standard Error of the Mean|2.81|<|0.001|2-Sided|95.0|-68.11|-56.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638037|NCT01953328|3010868|Superiority or Other||LS Mean Treatment Difference|-68.29|Standard Error of the Mean|2.24|<|0.001|2-Sided|95.0|-72.75|-63.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638038|NCT01953328|3010869|Superiority or Other||LS Mean Treatment Difference|-67.26|Standard Error of the Mean|2.07|<|0.001|2-Sided|95.0|-71.36|-63.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638039|NCT01953328|3010869|Superiority or Other||LS Mean Treatment Difference|-64.05|Standard Error of the Mean|2.44|<|0.001|2-Sided|95.0|-68.9|-59.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638040|NCT01953328|3010869|Superiority or Other||LS Mean Treatment Difference|-64.33|Standard Error of the Mean|2.35|<|0.001|2-Sided|95.0|-69.01|-59.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638041|NCT01953328|3010869|Superiority or Other||LS Mean Treatment Difference|-66.47|Standard Error of the Mean|2.07|<|0.001|2-Sided|95.0|-70.58|-62.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638042|NCT01953328|3010870|Superiority or Other||LS Mean Treatment Difference|-45.44|Standard Error of the Mean|2.33|<|0.001|2-Sided|95.0|-50.08|-40.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638043|NCT01953328|3010870|Superiority or Other||LS Mean Treatment Difference|-51.36|Standard Error of the Mean|2.3|<|0.001|2-Sided|95.0|-55.93|-46.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638044|NCT01953328|3010870|Superiority or Other||LS Mean Treatment Difference|-50.95|Standard Error of the Mean|2.5|<|0.001|2-Sided|95.0|-55.91|-46.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638045|NCT01953328|3010870|Superiority or Other||LS Mean Treatment Difference|-55.45|Standard Error of the Mean|2.76|<|0.001|2-Sided|95.0|-60.93|-49.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638046|NCT01953328|3010871|Superiority or Other||LS Mean Treatment Difference|-49.69|Standard Error of the Mean|2.04|<|0.001|2-Sided|95.0|-53.74|-45.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638047|NCT01953328|3010871|Superiority or Other||LS Mean Treatment Difference|-50.83|Standard Error of the Mean|1.96|<|0.001|2-Sided|95.0|-54.72|-46.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638048|NCT01953328|3010871|Superiority or Other||LS Mean Treatment Difference|-52.66|Standard Error of the Mean|2.17|<|0.001|2-Sided|95.0|-56.95|-48.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638049|NCT01953328|3010871|Superiority or Other||LS Mean Treatment Difference|-54.77|Standard Error of the Mean|2.32|<|0.001|2-Sided|95.0|-59.37|-50.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638050|NCT01953328|3010872|Superiority or Other||LS Mean Treatment Difference|-38.44|Standard Error of the Mean|1.93|<|0.001|2-Sided|95.0|-42.26|-34.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638051|NCT01953328|3010872|Superiority or Other||LS Mean Treatment Difference|-40.96|Standard Error of the Mean|2.21|<|0.001|2-Sided|95.0|-45.35|-36.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638052|NCT01953328|3010872|Superiority or Other||LS Mean Treatment Difference|-41.34|Standard Error of the Mean|1.76|<|0.001|2-Sided|95.0|-44.84|-37.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638053|NCT01953328|3010872|Superiority or Other||LS Mean Treatment Difference|-45.44|Standard Error of the Mean|2.21|<|0.001|2-Sided|95.0|-49.83|-41.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638054|NCT01953328|3010873|Superiority or Other||LS Mean Treatment Difference|-43.14|Standard Error of the Mean|1.68|<|0.001|2-Sided|95.0|-46.48|-39.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638055|NCT01953328|3010873|Superiority or Other||LS Mean Treatment Difference|-40.98|Standard Error of the Mean|1.96|<|0.001|2-Sided|95.0|-44.88|-37.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638056|NCT01953328|3010873|Superiority or Other||LS Mean Treatment Difference|-43.43|Standard Error of the Mean|1.69|<|0.001|2-Sided|95.0|-46.78|-40.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638057|NCT01953328|3010873|Superiority or Other||LS Mean Treatment Difference|-45.54|Standard Error of the Mean|1.92|<|0.001|2-Sided|95.0|-49.35|-41.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638058|NCT01953328|3010874|Superiority or Other||LS Mean Treatment Difference|-56.15|Standard Error of the Mean|2.4|<|0.001|2-Sided|95.0|-60.92|-51.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638059|NCT01953328|3010874|Superiority or Other||LS Mean Treatment Difference|-60.37|Standard Error of the Mean|2.79|<|0.001|2-Sided|95.0|-65.91|-54.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638060|NCT01953328|3010874|Superiority or Other||LS Mean Treatment Difference|-57.23|Standard Error of the Mean|2.43|<|0.001|2-Sided|95.0|-62.05|-52.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638090|NCT01953237|3010882|Superiority or Other (legacy)|||||||0.558|||||||Mixed Models Analysis||||
1638091|NCT01953211|3010894|Superiority or Other||Slope|0.83|Standard Deviation|0.78|<|0.01|2-Sided||||||t-test, 2 sided||||
1638262|NCT01948076|3011478|Superiority or Other|||||||0.11|||||||Wilcoxon (Mann-Whitney)||||
1638061|NCT01953328|3010874|Superiority or Other||LS Mean Treatment Difference|-65.56|Standard Error of the Mean|2.4|<|0.001|2-Sided|95.0|-70.34|-60.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638062|NCT01953328|3010875|Superiority or Other||LS Mean Treatment Difference|-63.39|Standard Error of the Mean|1.9|<|0.001|2-Sided|95.0|-67.15|-59.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638063|NCT01953328|3010875|Superiority or Other||LS Mean Treatment Difference|-60.06|Standard Error of the Mean|2.42|<|0.001|2-Sided|95.0|-64.87|-55.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638064|NCT01953328|3010875|Superiority or Other||LS Mean Treatment Difference|-59.24|Standard Error of the Mean|2.05|<|0.001|2-Sided|95.0|-63.3|-55.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638065|NCT01953328|3010875|Superiority or Other||LS Mean Treatment Difference|-64.44|Standard Error of the Mean|2.04|<|0.001|2-Sided|95.0|-68.49|-60.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638066|NCT01953328|3010876|Superiority or Other||LS Mean Treatment Difference|-60.89|Standard Error of the Mean|2.47|<|0.001|2-Sided|95.0|-65.78|-55.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638067|NCT01953328|3010876|Superiority or Other||LS Mean Treatment Difference|-68.82|Standard Error of the Mean|3.01|<|0.001|2-Sided|95.0|-74.79|-62.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638068|NCT01953328|3010876|Superiority or Other||LS Mean Treatment Difference|-63.58|Standard Error of the Mean|2.2|<|0.001|2-Sided|95.0|-67.96|-59.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638069|NCT01953328|3010876|Superiority or Other||LS Mean Treatment Difference|-68.93|Standard Error of the Mean|2.54|<|0.001|2-Sided|95.0|-73.96|-63.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638070|NCT01953328|3010877|Superiority or Other||LS Mean Treatment Difference|-67.28|Standard Error of the Mean|1.94|<|0.001|2-Sided|95.0|-71.14|-63.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638071|NCT01953328|3010877|Superiority or Other||LS Mean Treatment Difference|-68.14|Standard Error of the Mean|2.6|<|0.001|2-Sided|95.0|-73.3|-62.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638072|NCT01953328|3010877|Superiority or Other||LS Mean Treatment Difference|-65.95|Standard Error of the Mean|1.91|<|0.001|2-Sided|95.0|-69.74|-62.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638073|NCT01953328|3010877|Superiority or Other||LS Mean Treatment Difference|-68.67|Standard Error of the Mean|2.21|<|0.001|2-Sided|95.0|-73.06|-64.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638074|NCT01953328|3010878|Superiority or Other||LS Mean Treatment Difference|-65.5|Standard Error of the Mean|4.2|<|0.001|2-Sided|95.0|-73.8|-57.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638075|NCT01953328|3010878|Superiority or Other||LS Mean Treatment Difference|-69.6|Standard Error of the Mean|3.5|<|0.001|2-Sided|95.0|-76.5|-62.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638076|NCT01953328|3010878|Superiority or Other||LS Mean Treatment Difference|-83.6|Standard Error of the Mean|4.5|<|0.001|2-Sided|95.0|-92.5|-74.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638092|NCT01953211|3010894|Superiority or Other||Slope|0.63|Standard Deviation|0.9|<|0.01|2-Sided||||||t-test, 2 sided||||
1638093|NCT01953211|3010894|Superiority or Other||Slope|0.02|Standard Deviation|0.57|<|0.88|2-Sided||||||t-test, 2 sided||||
1638077|NCT01953328|3010878|Superiority or Other||LS Mean Treatment Difference|-90.8|Standard Error of the Mean|5.1|<|0.001|2-Sided|95.0|-100.9|-80.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638078|NCT01953328|3010879|Superiority or Other||LS Mean Treatment Difference|-72.0|Standard Error of the Mean|3.7|<|0.001|2-Sided|95.0|-79.5|-64.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638079|NCT01953328|3010879|Superiority or Other||LS Mean Treatment Difference|-68.7|Standard Error of the Mean|3.3|<|0.001|2-Sided|95.0|-75.3|-62.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638080|NCT01953328|3010879|Superiority or Other||LS Mean Treatment Difference|-86.3|Standard Error of the Mean|4.4|<|0.001|2-Sided|95.0|-95.1|-77.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638081|NCT01953328|3010879|Superiority or Other||LS Mean Treatment Difference|-89.3|Standard Error of the Mean|4.6|<|0.001|2-Sided|95.0|-98.4|-80.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference||
1638082|NCT01953328|3010880|Superiority or Other||LS Mean Treatment Difference|-66.87|Standard Error of the Mean|3.03|<|0.001|2-Sided|95.0|-72.88|-60.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1638083|NCT01953328|3010880|Superiority or Other||LS Mean Treatment Difference|-78.85|Standard Error of the Mean|3.88|<|0.001|2-Sided|95.0|-83.55|-68.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1638084|NCT01953328|3010880|Superiority or Other||LS Mean Treatment Difference|-69.91|Standard Error of the Mean|2.36|<|0.001|2-Sided|95.0|-74.6|-65.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1638085|NCT01953328|3010880|Superiority or Other||LS Mean Treatment Difference|-74.85|Standard Error of the Mean|2.71|<|0.001|2-Sided|95.0|-80.22|-69.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1638086|NCT01953328|3010881|Superiority or Other||LS Mean Treatment Difference|-74.27|Standard Error of the Mean|2.35|<|0.001|2-Sided|95.0|-78.93|-69.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1638087|NCT01953328|3010881|Superiority or Other||LS Mean Treatment Difference|-74.41|Standard Error of the Mean|3.43|<|0.001|2-Sided|95.0|-81.21|-67.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1638088|NCT01953328|3010881|Superiority or Other||LS Mean Treatment Difference|-72.89|Standard Error of the Mean|2.18|<|0.001|2-Sided|95.0|-77.22|-68.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1638089|NCT01953328|3010881|Superiority or Other||LS Mean Treatment Difference|-73.97|Standard Error of the Mean|2.3|<|0.001|2-Sided|95.0|-78.54|-69.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit, and the interaction of treatment group with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no difference in the percent change from baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1638094|NCT01952678|3010912|Equivalence|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|2.2||||0.6577|2-Sided|95.0|-12.0|16.1|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638095|NCT01952678|3010912|Equivalence|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.1||||0.8214|2-Sided|95.0|-13.0|15.0|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638096|NCT01952678|3010912|Equivalence|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-1.9||||0.8429|2-Sided|95.0|-16.1|12.0|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638097|NCT01952678|3010912|Equivalence|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.0||||1|2-Sided|95.0|-13.5|15.6|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638098|NCT01952678|3010913|Equivalence|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.1||||0.834|2-Sided|95.0|-12.8|14.7|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638099|NCT01952678|3010913|Equivalence|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.1||||1|2-Sided|95.0|-13.8|13.8|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638100|NCT01952678|3010913|Equivalence|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-3.8||||0.5731|2-Sided|95.0|-17.7|9.8|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638101|NCT01952678|3010913|Equivalence|Analysis was performed using the hypothesis: OPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.0||||1|2-Sided|95.0|-13.3|15.3|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638102|NCT01952678|3010914|Equivalence|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|2.7||||0.7123|2-Sided|95.0|-19.1|23.9|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638103|NCT01952678|3010914|Equivalence|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.2||||1|2-Sided|95.0|-21.5|21.5|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638104|NCT01952678|3010914|Equivalence|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|5.2||||0.5187|2-Sided|95.0|-16.7|26.2|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638105|NCT01952678|3010914|Equivalence|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.0||||1|2-Sided|95.0|-22.8|22.8|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638106|NCT01952678|3010915|Equivalence|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.3||||1|2-Sided|95.0|-20.8|20.8|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638107|NCT01952678|3010915|Equivalence|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-2.0||||1|2-Sided|95.0|-23.0|18.5|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638108|NCT01952678|3010915|Equivalence|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.4||||1|2-Sided|95.0|-20.8|20.8|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638109|NCT01952678|3010915|Equivalence|Analysis was performed using the hypothesis: NPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|0.0||||1|2-Sided|95.0|-22.0|22.0|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638110|NCT01952678|3010916|Equivalence|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|2-Sided|95.0|-17.5|20.9|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638111|NCT01952678|3010916|Equivalence|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|2-Sided|95.0|-17.5|20.9|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638112|NCT01952678|3010916|Equivalence|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-7.1||||0.4599|2-Sided|95.0|-26.1|12.2|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638113|NCT01952678|3010916|Equivalence|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|2-Sided|95.0|-17.5|20.9|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638114|NCT01952678|3010917|Equivalence|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|2-Sided|95.0|-17.3|20.7|||Fisher Exact|||Majority Read: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638115|NCT01952678|3010917|Equivalence|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|2-Sided|95.0|-17.3|20.7|||Fisher Exact|||Reader C: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638116|NCT01952678|3010917|Equivalence|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|-7.0||||0.4608|2-Sided|95.0|-25.8|12.1|||Fisher Exact|||Reader B: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638156|NCT01951326|3011107|Superiority|||||||0.01|||||||Log Rank||||
1638117|NCT01952678|3010917|Equivalence|Analysis was performed using the hypothesis: PPA was equal for Caucasian and non-Caucasian populations.|Mean Difference (Net)|1.8||||1|2-Sided|95.0|-17.3|20.7|||Fisher Exact|||Reader A: DaTscan™- Non-Caucasian Participants vs DaTscan™- Caucasian Participants|
1638118|NCT01952574|3010985|Superiority||LS Mean Difference|0.37||||0.16|2-Sided|95.0|-0.14|0.87|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.|||
1638119|NCT01952574|3010985|Superiority||LS Mean Difference|0.02||||0.95|2-Sided|95.0|-0.51|0.54|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.|||
1638120|NCT01952574|3010985|Superiority||LS Mean Difference|-0.4||||0.13|2-Sided|95.0|-0.92|0.12|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.|||
1638121|NCT01952574|3010986|Superiority||Odds Ratio (OR)|0.93||||0.8|2-Sided|95.0|0.53|1.63|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 107 in the erenumab 7 mg group)|
1638122|NCT01952574|3010986|Superiority||Odds Ratio (OR)|1.25||||0.44|2-Sided|95.0|0.71|2.18|||Generalized Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one change from baseline value in monthly migraine days (152 participants in the placebo group and 99 in the erenumab 21 mg group)|
1638123|NCT01952574|3010986|Superiority||Odds Ratio (OR)|2.0||||0.011|2-Sided|95.0|1.17|3.42|||Generalised Linear Mixed Model|Generalized linear mixed model including treatment, visit, treatment by visit, stratification factor region, and baseline value as covariates.||The generalized linear mixed model includes data for all participants in the efficacy analysis set with at least one percent change from baseline value in monthly migraine days (152 participants in the placebo group and 104 in the erenumab 70 mg group)|
1638124|NCT01952574|3010987|Superiority|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|0.11||||0.82|2-Sided|92.0|-0.83|1.05|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.|
1638125|NCT01952574|3010987|Superiority|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|-0.1||||0.83|2-Sided|95.0|-1.07|0.86|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.|
1638126|NCT01952574|3010987|Superiority|To maintain the type I error at ≤ 0.05, the pairwise comparison was tested in a sequential testing procedure in the order of erenumab 70 mg vs placebo, 21 mg vs placebo, and 7 mg vs placebo. The lower dose group was only to be tested when the higher dose group was tested as significant.|LS Mean Difference|-1.12||||0.021|2-Sided|95.0|-2.06|-0.17|||Generalized Linear Mixed Model|||The primary analysis utilized a generalized linear mixed model which included treatment, visit, treatment by visit, the stratification factor region, and baseline value as covariates.|
1638127|NCT01952301|3011021|Non-Inferiority or Equivalence|The primary hypothesis of the study evaluated whether CM was not inferior to Control in the generation of KT width from baseline to 6 months. A paired t-test was used to test for non-inferiority, using a one-sided significance level of 0.05 and a non-inferiority margin of 1.0 mm.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1638128|NCT01952145|3011024|Non-Inferiority or Equivalence|Non-inferiority of IDegLira versus IGlar was considered as confirmed, if the 95% confidence interval (CI) for the mean treatment difference was entirely below 0.30%.|Treatment contrast|-0.59|||<|0.001|2-Sided|95.0|-0.74|-0.45|||ANCOVA|||This primary endpoint was analysed on the FAS using an ANCOVA model with treatment and region as fixed effects and baseline HbA1c value as covariate.|
1638129|NCT01952041|3011038|Superiority||Slope|-2.7|Standard Error of the Mean|1.4||0.06|2-Sided|95.0|-5.4|0.04|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.||
1638130|NCT01952041|3011039|Superiority||Slope|0.02|Standard Error of the Mean|0.12||0.84|2-Sided|95.0|-0.22|0.26|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.||
1638131|NCT01952041|3011040|Superiority||Slope|0.22|Standard Error of the Mean|0.41||0.58|2-Sided|95.0|-0.58|1.02|||Mixed Models Analysis||Treatment by time interaction terms are given to test difference of slopes between arms.||
1638132|NCT01952041|3011041|Superiority||Hazard Ratio (HR)|0.78||||0.43|2-Sided|95.0|0.42|1.44|||Regression, Cox||Hazard ratio is intervention arm vs. TAU for time to first relapse from randomization. There is not a standard error (SE) that directly links to the hazard ratio. The confidence interval provided illustrates the dispersion for the hazard ratio.||
1638133|NCT01952041|3011042|Superiority|||||||0.8|||||||Chi-squared|Chi-square test statistic=0.06, degrees of freedom=2|||
1638134|NCT01951586|3011069|Superiority or Other||Hazard Ratio (HR)|1.05||||0.7363|2-Sided|95.0|0.78|1.43|||Log Rank|Log rank test stratified by the randomized stratification factors.|"Based on a Cox proportional hazards model stratified by the randomized stratification factors.~Hazard ratio < 1 favors denosumab."||
1638135|NCT01951586|3011070|Superiority or Other||Odds Ratio (OR)|0.81||||0.4654|2-Sided|95.0|0.46|1.43|||Regression, Logistic|Logistic regression model adjusted for the randomization stratification factors.|Based on a logistic regression model adjusted for the randomization stratification factors; an odds ratio ≥ 1 favors denosumab.||
1638157|NCT01951326|3011108|Superiority|||||||0.0031|||||||Log Rank||||
1638158|NCT01951326|3011109|Superiority|||||||0.046|||||||Log Rank||||
1638136|NCT01951586|3011071|Superiority or Other|||||||0.4236|||||||Regression, Logistic|||The interaction of RANKL expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.|
1638137|NCT01951586|3011071|Superiority or Other|||||||0.4671|||||||Regression, Logistic|||The interaction of RANKL expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.|
1638138|NCT01951586|3011072|Superiority or Other|||||||0.2081|||||||Regression, Logistic|||The interaction of RANK expression level total (cytoplasm + membrane; H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.|
1638139|NCT01951586|3011072|Superiority or Other|||||||0.262|||||||Regression, Logistic|||The interaction of RANK expression level measured in the membranes (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.|
1638140|NCT01951586|3011072|Superiority or Other|||||||0.4329|||||||Regression, Logistic|||The interaction of RANK expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.|
1638141|NCT01951586|3011072|Superiority or Other|||||||0.223|||||||Regression, Logistic|||The interaction of RANK expression level total (cytoplasm + membrane; all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.|
1638142|NCT01951586|3011072|Superiority or Other|||||||0.2582|||||||Regression, Logistic|||The interaction of RANK expression level measured in the membranes (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.|
1638143|NCT01951586|3011072|Superiority or Other|||||||0.476|||||||Regression, Logistic|||The interaction of RANK expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a logistic regression model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.|
1638144|NCT01951586|3011073|Superiority or Other||Odds Ratio (OR)|0.76||||0.3491|2-Sided|95.0|0.43|1.35|||Regression, Logistic|Logistic regression model adjusted for the randomization stratification factors.|Based on a logistic regression model adjusted for the randomization stratification factors; an odds ratio ≥ 1 favors denosumab.||
1638145|NCT01951586|3011074|Superiority or Other|||||||0.3735|||||||Cox propotional hazard model|||The interaction of RANKL expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.|
1638146|NCT01951586|3011074|Superiority or Other|||||||0.3946|||||||Cox propotional hazard model|||The interaction of RANKL expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANKL expression level and treatment-by-RANKL expression level interaction stratified by the randomization stratification factors.|
1638147|NCT01951586|3011075|Superiority or Other|||||||0.1583|||||||Cox propotional hazard model|||The interaction of RANK expression level total (cytoplasm + membranes; H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.|
1638148|NCT01951586|3011075|Superiority or Other|||||||0.3179|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in membranes (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.|
1638149|NCT01951586|3011075|Superiority or Other|||||||0.3353|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in the cytoplasm (H-score) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.|
1638150|NCT01951586|3011075|Superiority or Other|||||||0.1917|||||||Cox propotional hazard model|||The interaction of RANK expression level total (cytoplasm + membranes; all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.|
1638151|NCT01951586|3011075|Superiority or Other|||||||0.3666|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in membranes (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.|
1638152|NCT01951586|3011075|Superiority or Other|||||||0.3759|||||||Cox propotional hazard model|||The interaction of RANK expression level measured in the cytoplasm (all intensity) and treatment effect was evaluated using a Cox proportional hazard model that included treatment group, RANK expression level and treatment-by-RANK expression level interaction stratified by the randomization stratification factors.|
1638153|NCT01951586|3011076|Superiority||Hazard Ratio (HR)|1.11||||0.5157|2-Sided|95.0|0.81|1.53|||Log Rank|Log rank test stratified by the randomization stratification factors.|"Based on a Cox proportional hazards model stratified by the randomized stratification factors.~Hazard ratio < 1 favors denosumab."||
1638154|NCT01951326|3011105|Superiority|||||||0.0422|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).|||
1638155|NCT01951326|3011106|Superiority|||||||0.0077|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).|||
1638162|NCT01951326|3011113|Superiority|||||||0.0851|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).|||
1638163|NCT01951326|3011114|Superiority|||||||0.0616|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).|||
1638164|NCT01951326|3011115|Superiority|||||||0.0116|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).|||
1638165|NCT01951326|3011116|Superiority|||||||0.0048|||||||Cochran-Mantel-Haenszel|Stratified according to anti-TNF agent use (Y/N).|||
1638166|NCT01951170|3011136|Superiority or Other|||||||0.83||||||Change in mTSS scores from baseline to Week 24.|Wilcoxon signed rank test||||
1638167|NCT01951157|3011137|Superiority|||||||0.8057|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of ilcoxon signed ranks test repeat-measure analyses of variance.|
1638168|NCT01951157|3011137|Superiority|||||||0.9862|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.|
1638169|NCT01951157|3011137|Superiority|Pre-specified||||||0.9026|||||||Wilcoxon signed ranks test repeat analys|||Changes in QoL scores over time were calculated and tested for statistical significance by means of wilcoxon signed ranks test repeat-measure analyses of variance.|
1638170|NCT01951157|3011138|Superiority or Other (legacy)|Pre-specified||||||0.3526|||||||Log Rank||||
1638171|NCT01951157|3011139|Superiority|Pre-specified|||||=|0|||||||Log Rank||||
1638172|NCT01951157|3011143|Superiority|Pre-specified|||||=|0|||||||Log Rank||||
1638173|NCT01951157|3011144|Superiority||The exact binomial estimator|28.0|||||2-Sided|95.0|12.6|46.7||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed|
1638174|NCT01951157|3011144|Superiority||The exact binomial estimator|19.0|||||2-Sided|95.0|5.7|37.9||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed|
1638175|NCT01951157|3011144|Superiority||The exact binomial estimator|29.2|||||2-Sided|95.0|13.2|48.4||||||The exact binomial estimator and its 95%CI was used. A pre-planned Bayesian supportive analysis test comparing PFS4 was performed.|
1638176|NCT01951105|3011146|Superiority|||||||1|||||||Fisher Exact||||
1638177|NCT01950819|3011171|Non-Inferiority|p vale for non inferiority margin is 10 %|Odds Ratio (OR)|3.0||||0.001|2-Sided|95.0|-1.4|7.3|||Logistic Regression Model|||calculated at month 12|
1638178|NCT01950273|3011232|Superiority or Other||Median Difference (Final Values)|2.0|||||2-Sided|95.0|-18.0|22.1|||||Difference in TEAE incidence calculated as BI695500 – TEAE incidence (MabThera®). The confidence interval represented is 95% difference in proportions.||
1638179|NCT01950273|3011233|Superiority or Other||Mean Difference (Final Values)|-9.4|||||2-Sided|95.0|-29.4|11.1|||||Difference in ORR calculated as ORR (BI695500) – ORR (MabThera®). The confidence interval represented is 95% difference in proportions.||
1638180|NCT01950273|3011235|Superiority or Other||Mean Difference (Final Values)|249.2|||||2-Sided|90.0|-210.6|709.0|||||Mean difference calculated as BI 695500-Rituximab (MabThera®).||
1638181|NCT01950273|3011236|Non-Inferiority or Equivalence|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|97.65|||||2-Sided|90.0|90.45|105.42|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).||
1638182|NCT01950273|3011237|Non-Inferiority or Equivalence|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|89.94|||||2-Sided|90.0|77.62|104.23|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).||
1638183|NCT01950273|3011238|Non-Inferiority or Equivalence|Standard equivalence limit 80% to 125%.|Least Squares (LS) means ratio|94.6||||||90.0|85.04|105.23|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).||
1638184|NCT01950273|3011239|Non-Inferiority or Equivalence|Standard equivalence limit 80% to 125%.|Least Squares (LS) mean ratio|89.53|||||2-Sided|90.0|75.42|106.29|||||Ratio of the adjusted geometric means calculated as (LS mean ratio of BI 695500/Rituximab (MabThera®)).||
1638185|NCT01950260|3011240|Superiority|||||||0.33|||||||Regression, Linear||||
1638186|NCT01950260|3011241|Superiority|||||||0.41|||||||Regression, Linear||||
1638187|NCT01950260|3011242|Superiority|||||||0.23|||||||Fisher Exact||||
1638188|NCT01949545|3011285|Superiority or Other||Geometric Mean Ratio|143.53||||0.07247|2-Sided|95.0|103.28|199.45|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-inf an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.|
1638189|NCT01949545|3011285|Superiority or Other||Geometric Mean Ratio|151.84||||0.02137|2-Sided|95.0|113.59|202.96|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-inf an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.|
1638190|NCT01949545|3011286|Superiority or Other||Geometric Mean Ratio|126.08||||0.1812|2-Sided|95.0|94.59|168.06|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-last an ANOVA of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.|
1638219|NCT01948986|3011408|Superiority or Other||Ratio (Heathy Normal/T2DM Normal)|80.39|||||2-Sided|90.0|59.41|108.76|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638220|NCT01948986|3011415|Superiority or Other||Ratio (Severe Renal Impair./Pooled Norm.|90.18|||||2-Sided|90.0|71.99|112.96|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638191|NCT01949545|3011286|Superiority or Other||Geometric Mean Ratio|144.43||||0.02232|2-Sided|95.0|111.48|187.12|||ANOVA||The geometric mean ratio was calculated by exponentiation of the differences in the least squares means, using log-transformed data, between the hepatic impairment cohort (test) and participants with normal hepatic function (reference).|To assess the effect of hepatic impairment relative to participants with normal hepatic function on AUC0-last an analysis of variance (ANOVA) of the log-transformed plasma PK parameters was performed. The ANOVA model included hepatic impairment as a fixed effect.|
1638192|NCT01949532|3011317|Superiority or Other||Ratio of geometric means|133.62|||||2-Sided|90.0|70.93|251.73|||||||
1638193|NCT01949532|3011318|Superiority or Other||Ratio of geometric means|132.75|||||2-Sided|90.0|70.6|249.63|||||The point estimates of the geometric mean ratios for the PK parameters were calculated by exponentiation of the differences in the least-squares means between the renal impairment group (test) and participants with normal renal function (reference).||
1638194|NCT01949480|3011320|Non-Inferiority|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.783|||||||t-test, 2 sided||||
1638195|NCT01949480|3011321|Non-Inferiority|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.913|||||||t-test, 2 sided||||
1638196|NCT01949480|3011322|Non-Inferiority|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.574|||||||t-test, 2 sided||||
1638197|NCT01949480|3011323|Non-Inferiority|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.493|||||||t-test, 2 sided||||
1638198|NCT01949480|3011324|Non-Inferiority|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.487|||||||t-test, 2 sided||||
1638199|NCT01949480|3011325|Non-Inferiority|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.308|||||||t-test, 2 sided||||
1638200|NCT01949480|3011326|Non-Inferiority|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.104|||||||t-test, 2 sided|||This p-value is for the Local Anesthetic infused in 24 hrs.|
1638201|NCT01949480|3011327|Non-Inferiority|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.605|||||||t-test, 2 sided||||
1638202|NCT01949480|3011328|Non-Inferiority|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.39|||||||t-test, 2 sided|||This p-value is calculated for the NRS during deep inspiration at 24 hrs.|
1638203|NCT01949480|3011328|Non-Inferiority|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.077|||||||t-test, 2 sided|||This p-value is calculated for the NRS at rest.|
1638204|NCT01949480|3011330|Non-Inferiority|To detect an effect size of 0.92 SD units with a power of 81% and alpha level of 0.05, a total sample size of 40 patients (20 patients/group) was calculated.||||||0.643|||||||t-test, 2 sided||||
1638205|NCT01949116|3011351|Superiority||Mean Difference (Final Values)|0.09||||0.55|2-Sided|95.0|-0.67|0.85|||Wilcoxon (Mann-Whitney)|Stratified by Statin Use (study stratification factor)|||
1638206|NCT01949116|3011352|Non-Inferiority|The P-value for the risk difference is from an asymptotic non-inferiority analysis for the proportion (risk) difference with a 15% non-inferiority margin.|Risk Difference (RD)|0.072||||0.0367|1-Sided|90.0||0.134|||Farrington-Manning score (exact)||LDMTX - Placebo||
1638207|NCT01949051|3011388|Non-Inferiority or Equivalence|Levocabastine OD would be declared as non-inferior to levocabastine BID if upper limit of 95% confidence interval of the treatment difference estimate (OD vs BD) was less than 1|Mean Difference (Final Values)|0.231|||||2-Sided|95.0|-0.361|0.823|||||||
1638208|NCT01949051|3011388|Superiority or Other||Mean Difference (Final Values)|-1.118||||0.0003|2-Sided|95.0|-1.712|-0.525|||Mixed Model ANOVA||||
1638209|NCT01949051|3011388|Superiority or Other||Mean Difference (Final Values)|-1.35|||<|0.0001|2-Sided|95.0|-1.943|-0.756|||Mixed Model ANOVA||||
1638210|NCT01948986|3011389|Superiority or Other||Ratio (Sev. Renal Impair./T2DM Norm. Ren|13.95|||||2-Sided|90.0|7.32|26.58|||||The model was an ANOVA model with renal function group as a fixed effect.||
1638211|NCT01948986|3011389|Superiority or Other||Ratio (Mod. Renal Impair./T2DM Norm. Ren|38.1|||||2-Sided|90.0|20.85|69.64|||||The model was an ANOVA model with renal function group as a fixed effect.||
1638212|NCT01948986|3011389|Superiority or Other||Ratio (Mild Renal Impair./T2DM Norm. Ren|49.75|||||2-Sided|90.0|27.22|90.93|||||The model was an ANOVA model with renal function group as a fixed effect.||
1638213|NCT01948986|3011391|Superiority or Other||Ratio: Sev. Ren. Impa./T2DM Norm. Renal|72.74|||||2-Sided|95.0|44.63|118.58|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.||
1638214|NCT01948986|3011391|Superiority or Other||Ratio: Mod. Ren. Impa./T2DM Norm. Renal|86.52|||||2-Sided|95.0|54.78|136.65|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.||
1638215|NCT01948986|3011391|Superiority or Other||Ratio: Mild Ren. Impa./T2DM Norm. Renal|76.73|||||2-Sided|95.0|48.58|121.19|||||Adjusted geometrics mean values were used. The model was an ANOVA model with renal function group as a fixed effect.||
1638216|NCT01948986|3011408|Superiority or Other||Ratio (Severe Renal Impair./Pooled Norm.|29.02|||||2-Sided|90.0|22.04|38.21|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638217|NCT01948986|3011408|Superiority or Other||Ratio (Mod. Renal Impair./Pooled Norm.)|43.45|||||2-Sided|90.0|33.85|55.78|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638218|NCT01948986|3011408|Superiority or Other||Ratio (Mild Renal Impair./Pooled Norm.)|53.46|||||2-Sided|90.0|41.64|68.63|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638221|NCT01948986|3011415|Superiority or Other||Ratio (Mod. Renal Impair./Pooled Norm.)|140.37|||||2-Sided|90.0|114.4|172.23|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638222|NCT01948986|3011415|Superiority or Other||Ratio (Mild Renal Impair./Pooled Norm.)|143.74|||||2-Sided|90.0|117.15|176.37|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638223|NCT01948986|3011415|Superiority or Other||Ratio (Heathy Normal/T2DM Normal)|101.57|||||2-Sided|90.0|78.83|130.87|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638224|NCT01948986|3011417|Superiority or Other||Ratio (Severe Renal Impair./Pooled Norm.|151.8|||||2-Sided|90.0|121.69|189.36|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638225|NCT01948986|3011417|Superiority or Other||Ratio (Mod. Renal Impair./Pooled Norm.)|168.11|||||2-Sided|90.0|137.53|205.49|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638226|NCT01948986|3011417|Superiority or Other||Ratio (Mild Renal Impair./Pooled Norm.)|151.63|||||2-Sided|90.0|124.05|185.34|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638227|NCT01948986|3011417|Superiority or Other||Ratio (Heathy Normal/T2DM Normal)|103.42|||||2-Sided|90.0|80.66|132.61|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638228|NCT01948986|3011418|Superiority or Other||Ratio (Severe Renal Impair./Pooled Norm.|155.26|||||2-Sided|90.0|124.38|193.8|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638229|NCT01948986|3011418|Superiority or Other||Ratio (Mod. Renal Impair./Pooled Norm.)|170.04|||||2-Sided|90.0|139.02|207.98|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638230|NCT01948986|3011418|Superiority or Other||Ratio (Mild Renal Impair./Pooled Norm.)|156.34|||||2-Sided|90.0|127.83|191.23|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638231|NCT01948986|3011418|Superiority or Other||Ratio (Heathy Normal/T2DM Normal)|103.07|||||2-Sided|90.0|80.32|132.27|||||The model was an ANOVA model with renal function group as a fixed effect. The ratios (and 90% CIs) are expressed as percentages.||
1638232|NCT01948947|3011419|Other||||||=|0|||||||ANOVA||||
1638233|NCT01948947|3011420|Other||||||<|0.01||||||Change in Baseline to 1-month post-treatment|ANOVA||||
1638234|NCT01948947|3011420|Other||||||<|0.009|||||||ANOVA||||
1638235|NCT01948947|3011421|Other||||||<|0.01||||||Change from Baseline to 1-Month post-treatment|ANOVA||||
1638236|NCT01948947|3011421|Other||||||<|0.001||||||Change from Baseline to 1-Week post-treatment|ANOVA||||
1638237|NCT01948947|3011422|Other||||||<|0.001|||||||ANOVA|||Change from Baseline to 1-Month Post-Treatment|
1638238|NCT01948947|3011422|Other||||||<|0.0001|||||||ANOVA|||Change from Baseline to 1-Week Post-Treatment|
1638239|NCT01948830|3011439|Non-Inferiority or Equivalence|The following hypothesis was tested at a one-sided 0.025 level. Non-inferiority with respect to BCVA: H01: μtreat and extend - μmonthly ≤ - Δ versus HA1: μtreat and extend - μmonthly > - Δ where μtreat and extend and μmonthly are the unknown mean changes from baseline in BCVA to Month 12 in the treat and extend regimen and the monthly regimen, respectively. Δ is the non-inferiority margin and is pre-defined to be 5 letters for the justification of the margin.|||||<|0.001|||||||ANCOVA||||
1638240|NCT01948791|3011444|Non-Inferiority or Equivalence|If the upper limit of the 95% confidence interval of the mean difference between the baseline score and post-baseline score falls on the left of MeanP-MeanB+1.40, the post-baseline noninferiority to baseline can be concluded. If the upper limit of the 95% confidence interval of the mean difference between the baseline score and post-baseline score falls on the left of 0, superiority can be concluded.|||||<|0.001|||||||t-test, 1 sided|||The hypothesis to test the non-inferiority of post-baseline change in ADAS-Cog from baseline was: H0: μP – μB ≥ 1.40, Ha: μP – μB < 1.40 where μP and μB are the ADAS-Cog score (actual) at 16 weeks of Rivastigmine treatment and the baseline ADAS-Cog score (actual), respectively.|
1638241|NCT01948518|3011445|Superiority or Other||||||=|0|||||||t-test, 2 sided|||The average 6 minute walk distance at baseline was 1195±407 feet. After oral administration of sildenafil, 6 minute walk distance was 1214±383 feet (p=0.63).|
1638242|NCT01948518|3011446|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Assuming 15% change in absolute value of DLCO representing a significant clinical difference and a standard deviation of 17.4% in normal nonsmoking individuals [Miller A, Thornton JC, Warshaw R, et al. Am Rev Respir Dis. 1983;127 (suppl 3):270-277.], 13 subjects needed to be studied to reject the null hypothesis when there is no significant difference between DLCO measurements before and after sildenafil, with power 0.8 and type I error probability 0.05 (SAS 9.2, SAS Institute Inc., Cary, NC)|
1638243|NCT01948375|3011452|Superiority or Other||Odds Ratio (OR)|1.63|||=|0||95.0|1.01|2.64||For the comparison of direct effect of placebo needle and real needle, p=0.048|Generalized Estimating Equation||||
1638244|NCT01948375|3011453|Superiority or Other||||||=|0||||||"for the comparison of difference of acupuncture pain in two periods between the two groups,t=-2.88, p=0.006.~t=-2.88 refers to the t value of t test."|t-test, 2 sided||||
1638245|NCT01948375|3011454|Superiority or Other||Odds Ratio (OR)|2.35||||0.007||95.0|1.26|4.4||For the comparison of direct effect of placebo needle and real needle, p=0.007|Generalized Estimating Equation||||
1638246|NCT01948375|3011456|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1638247|NCT01948310|3011457|Superiority|||||||0.013|||||||t-test, 2 sided|||14-0 weeks|
1638248|NCT01948310|3011457|Superiority||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks|
1638249|NCT01948310|3011457|Superiority||||||>|0.13|||||||t-test, 2 sided|||0-14 weeks|
1638250|NCT01948310|3011457|Superiority||||||>|0.05|||||||t-test, 2 sided|||2-0 weeks|
1638251|NCT01948310|3011458|Superiority||||||>|0.05|||||||t-test, 2 sided|||14-0 weeks|
1638252|NCT01948310|3011458|Superiority||||||>|0.03|||||||t-test, 2 sided|||2-0 weeks|
1638263|NCT01947855|3011510|Superiority or Other||Mean Difference (Net)|-85.49|Standard Error of the Mean|20.18|<|0.0001|2-Sided|95.0|-126.01|-44.97|||ANCOVA|Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.||Difference calculated as empa 10 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.|
1638264|NCT01947855|3011510|Superiority or Other||Mean Difference (Net)|-104.87|Standard Error of the Mean|19.88|<|0.0001|2-Sided|95.0|-144.77|-64.97|||ANCOVA|Model includes treatment, number of previous antidiabetic medication, baseline renal function, baseline HbA1c and baseline AUC1-4h for plasma glucose.||Difference calculated as empa 25 mg minus placebo. The analyses will be performed sequentially compared with placebo from high dose of empagliflozin and the full significance level (5%) will be maintained by the hierarchical procedure.|
1638265|NCT01947816|3011511|Superiority||||||<|0.0001|||||||paired t-test|||Change from Baseline at Final Assessment|
1638266|NCT01947816|3011511|Superiority||||||<|0.0001|||||||paired t-test|||Change from Baseline when discontinued|
1638267|NCT01947816|3011511|Superiority||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 52|
1638268|NCT01947816|3011511|Superiority||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 24|
1638269|NCT01947816|3011511|Superiority||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 16|
1638270|NCT01947816|3011511|Superiority||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 8|
1638271|NCT01947816|3011511|Superiority||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 4|
1638272|NCT01947816|3011513|Superiority||||||<|0.0001|||||||paired t-test|||Change from Baseline at Final Assessment|
1638273|NCT01947816|3011513|Superiority||||||<|0.5512|||||||paired t-test|||Change from Baseline When Discontinued|
1638274|NCT01947816|3011513|Superiority||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 52|
1638275|NCT01947816|3011513|Superiority||||||<|0.0001|||||||paired t-test|||Change from Baseline at Week 24|
1638276|NCT01947491|3011531|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1638277|NCT01947153|3011541|Non-Inferiority or Equivalence|Bioequivalence test|Geometric mean ratio|102.92|Standard Error of the Mean|1.027|<|0.0001|2-Sided|90.0|98.37|107.688||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.||
1638278|NCT01947153|3011542|Non-Inferiority or Equivalence|Bioequivalence test|Geometric mean ratio|104.62|Standard Error of the Mean|1.031|<|0.0001|2-Sided|90.0|99.274|110.254||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.||
1638279|NCT01947153|3011543|Non-Inferiority or Equivalence|Bioequivalence test|Geometric mean ratio|98.48|Standard Error of the Mean|1.04|<|0.0001|2-Sided|90.0|92.177|105.208||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.||
1638280|NCT01947153|3011544|Non-Inferiority or Equivalence|Bioequivalence test|Geometric mean ratio|105.81|Standard Error of the Mean|1.043|<|0.0001|2-Sided|90.0|98.471|113.692||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.||
1638281|NCT01947153|3011545|Non-Inferiority or Equivalence|Bioequivalence test|Geometric mean ratio|109.05|Standard Error of the Mean|1.063||0.0014|2-Sided|90.0|98.299|120.968||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.||
1638282|NCT01947153|3011546|Non-Inferiority or Equivalence|Bioequivalence test|Geometric mean ratio|105.14|Standard Error of the Mean|1.032|<|0.0001|2-Sided|90.0|99.645|110.941||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.||
1638283|NCT01947153|3011547|Non-Inferiority or Equivalence|Bioequivalence test|Geometric mean ratio|102.92|Standard Error of the Mean|1.027|<|0.0001|2-Sided|90.0|98.37|107.688||The p-value relates to the null hypothesis of non-equivalence.|ANOVA||The geometric mean ratio is calculated as the geometric mean of 'Fixed dose combination' divided by the geometric mean of 'Free combination '.||
1638284|NCT01946282|3011577|Equivalence|||||||0.184|||||||Chi-squared||||
1638285|NCT01946282|3011577|Equivalence||||||>|0.99|||||||Chi-squared||||
1638286|NCT01946282|3011577|Equivalence|We estimated needing 545 observations per incentive group to achieve power necessary to detect at least a 10% absolute difference in FIT return rate between patients who received the $5 incentive versus patients who received the $10 incentive, with assumed rates of 45% in the $5 incentive group and 53% in the $10 incentive group, a=0.05, and power=90%.|||||>|0.033|||||||Chi-squared||||
1638287|NCT01946282|3011577|Equivalence|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.|||||>|0.033|||||||Chi-squared||||
1638288|NCT01946282|3011577|Equivalence|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.|||||>|0.82|||||||Chi-squared||||
1638289|NCT01946282|3011577|Equivalence|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.|||||>|0.31|||||||Chi-squared||||
1638316|NCT01945970|3011622|Superiority or Other||Median Difference (Final Values)|0.44||||0.72|2-Sided|95.0|-2.06|2.95|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects|Effect of positive control adjusted for placebo||
1638290|NCT01946282|3011577|Equivalence|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.|||||>|0.6|||||||Chi-squared||||
1638291|NCT01946282|3011577|Equivalence|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.|||||>|0.8|||||||Chi-squared||||
1638292|NCT01946282|3011577|Equivalence|Based on design, at a significance level of 0.05 group size was set to detect an minimum absolute difference in return rate of 10%, while maintaining more than 90% power. Baseline return rates were projected per group using prior study data: 29% for the outreach only group, 45% in the $5 incentive group, and 53% in the $10 incentive group.|||||>|0.07|||||||Chi-squared||||
1638293|NCT01946282|3011578|Equivalence|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.08|||||||Chi-squared||||
1638294|NCT01946282|3011578|Equivalence|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.75|||||||Chi-squared||||
1638295|NCT01946282|3011578|Equivalence|Assuming a FIT return rate of 29% for the outreach only group at an a=0.05, we estimated more than 90% power to detect an absolute difference greater than 5% when using a chi-square test of proportions to compare patients who received any incentive ($5 or $10) compared with patients who received outreach only.||||||0.59|||||||Chi-squared||||
1638296|NCT01946243|3011579|Superiority or Other|||||||0.0025|||||||t-test, 2 sided|||Paired t-test to test whether the change is equal to zero or not.|
1638297|NCT01946243|3011580|Superiority or Other||lower bound of two-sided 95% CI|0.07||||0.028|2-Sided|95.0|0.007|0.125|||Monte Carlo test|||Superiority demonstrated if lower bound of two-sided 95% CI greater than 0, for the change in kappa statistic.|
1638298|NCT01946243|3011581|Non-Inferiority or Equivalence|Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.|Mean Difference (Net)|2.3|||||1-Sided|97.5|0.8||||||Units: Percent Accuracy||
1638299|NCT01946243|3011582|Superiority or Other||lower bound of two-sided 95% CI|0.06|||||2-Sided|95.0|0.018|0.112||||||Superiority demonstrated if lower bound of two-sided 95% confidence interval (CI) greater than 0, for the change in kappa statistic.|
1638300|NCT01946243|3011583|Non-Inferiority or Equivalence|Non-inferiority demonstrated if the lower bound of the one-sided 97.5% confidence interval is greater than -3%.|Mean Difference (Net)|4.2|||||1-Sided|97.5|2.7||||||Units: Percent Accuracy||
1638301|NCT01946243|3011584|Superiority or Other|||||||0.0029|||||||t-test, 2 sided|||Paired t-test to test whether the change is equal to zero or not.|
1638302|NCT01946204|3011585|Superiority||Hazard Ratio (HR)|0.297|||<|0.0001|2-Sided|95.0|0.244|0.362|||Log Rank|||Statistical Analysis for MFS by BICR (Ex-US Regulatory)|
1638303|NCT01946204|3011585|Superiority||Hazard Ratio (HR)|0.28|||<|0.0001|2-Sided|95.0|0.227|0.346|||Log Rank|||Statistical Analysis for MFS by BICR (US Regulatory)|
1638304|NCT01946204|3011588|Superiority||Hazard Ratio (HR)|0.447|||<|0.0001|2-Sided|95.0|0.315|0.634|||Log Rank|||Statistical Analysis for Time to Symptomatic Progression|
1638305|NCT01946204|3011589|Superiority||Hazard Ratio (HR)|0.3|||<|0.0001|2-Sided|95.0|0.247|0.364|||Log Rank|||Statistical Analysis for PFS by BICR (EX-US Regulatory)|
1638306|NCT01946204|3011589|Superiority||Hazard Ratio (HR)|0.291|||<|0.0001|2-Sided|95.0|0.238|0.356|||Log Rank|||Statistical Analysis for PFS by BICR (US Regulatory)|
1638307|NCT01946204|3011590|Superiority||Hazard Ratio (HR)|0.279|||<|0.0001|2-Sided|95.0|0.227|0.342|||Log Rank|||Statistical Analysis for TTM by BICR (Ex-US Regulatory)|
1638308|NCT01946204|3011590|Superiority||Hazard Ratio (HR)|0.271|||<|0.0001|2-Sided|95.0|0.219|0.335|||Log Rank|||Statistical Analysis for TTM by BICR (US Regulatory)|
1638309|NCT01945970|3011615|Superiority or Other||Mean Difference (Final Values)|0.4||||0.55|2-Sided|95.0|-0.93|1.73|||Mixed Models Analysis||Effect of positive control adjusted for placebo||
1638310|NCT01945970|3011616|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.11|2-Sided|95.0|-2.7|0.3|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo||
1638311|NCT01945970|3011617|Superiority or Other||Mean Difference (Final Values)|-0.33||||0.66|2-Sided|95.0|-1.84|1.17|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo||
1638312|NCT01945970|3011618|Superiority or Other||Mean Difference (Final Values)|0.22||||0.74|2-Sided|95.0|-1.11|1.54|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects|
1638313|NCT01945970|3011619|Superiority or Other||Mean Difference (Final Values)|-0.62||||0.41|2-Sided|95.0|-2.12|0.88|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo||
1638314|NCT01945970|3011620|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.74|2-Sided|95.0|-1.75|1.24|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo||
1638315|NCT01945970|3011621|Superiority or Other||Mean Difference (Final Values)|0.86||||0.39|2-Sided|95.0|-1.15|2.88|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects|Effect of positive control adjusted for placebo||
1638317|NCT01945970|3011623|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.69|2-Sided|95.0|-2.41|1.62|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects.|Effect of black tea adjusted for placebo||
1638318|NCT01945970|3011624|Superiority or Other||Mean Difference (Final Values)|1.89||||0.14|2-Sided|95.0|-0.61|4.39|||Mixed Models Analysis|Subject as random factor and treatment and period as fixed effects.|Effect of black tea adjusted for placebo||
1638319|NCT01945970|3011625|Superiority or Other||Mean Difference (Final Values)|-0.38||||0.32|2-Sided|95.0|-1.13|0.37|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo||
1638320|NCT01945970|3011626|Superiority or Other||Mean Difference (Net)|0.71||||0.09|2-Sided|95.0|-0.11|1.53|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo||
1638321|NCT01945970|3011627|Superiority or Other||Median Difference (Final Values)|-0.49||||0.22|2-Sided|95.0|-1.3|0.31|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of positive control adjusted for placebo||
1638322|NCT01945970|3011628|Superiority or Other||Mean Difference (Final Values)|-0.89||||0.014|2-Sided|95.0|-1.59|-0.19|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo||
1638323|NCT01945970|3011629|Superiority or Other||Mean Difference (Final Values)|0.52||||0.18|2-Sided|95.0|-0.24|1.28|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo||
1638324|NCT01945970|3011630|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.36|2-Sided|95.0|-1.09|0.4|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Effect of black tea adjusted for placebo||
1638325|NCT01945775|3011647|Superiority||Hazard Ratio (HR)|0.392||||0.0053|2-Sided|95.0|0.198|0.775|||Log Rank|||Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system).|
1638326|NCT01945775|3011648|Superiority||Hazard Ratio (HR)|0.376|||<|0.0001|2-Sided|95.0|0.257|0.549|||Log Rank|||Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).|
1638327|NCT01945775|3011649|Superiority||Mean Difference (Final Values)|8.4|||<|0.0001|2-Sided|95.0|4.6|12.3|||Mixed Models Analysis|||Analysis was based on repeated measures mixed-effect model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate. Analysis was based on restricted maximum likelihood using unstructured covariance matrix.|
1638328|NCT01945775|3011657|Superiority||Hazard Ratio (HR)|0.761||||0.1053|2-Sided|95.0|0.547|1.06|||Log Rank|||Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).|
1638329|NCT01945775|3011658|Superiority||Odds Ratio (OR)|4.99|||<|0.0001|2-Sided|95.0|2.93|8.83|||Cochran-Mantel-Haenszel|||p-value was based on stratified Cochran-Mantel-Haenszel method. Stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status.|
1638330|NCT01945775|3011659|Superiority||Hazard Ratio, log|0.542|||<|0.0001|2-Sided|95.0|0.413|0.711|||Log Rank|||Hazard ratio was based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).|
1638331|NCT01945294|3011712|Superiority or Other||Difference in SVR12 percentage|-11.4|||||2-Sided|95.0|-23.2|0.4|||||||
1638332|NCT01945281|3011714|Other|Miettinen & Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel-Haenszel’s weights.|Difference in Percentage|-6.3|||||2-Sided|95.0|-30.2|22.6|||||Caspofungin minus Amphotericin||
1638333|NCT01945281|3011715|Other|Miettinen & Nurminen method stratified by stratum (Weight category based on weight at study entry) with Cochran Mantel-Haenszel’s weights.|Difference in Percentage|-0.9|||||2-Sided|95.0|-24.3|27.7|||||Caspofungin minus Amphotericin||
1638334|NCT01945138|3011725|Superiority or Other|||||||0.311|||||||t-test, 2 sided||||
1638335|NCT01945138|3011726|Superiority or Other|||||||0.325|||||||t-test, 2 sided||||
1638336|NCT01945138|3011727|Superiority or Other|||||||0.22|||||||t-test, 2 sided||||
1638337|NCT01945138|3011728|Superiority or Other|||||||0.401|||||||t-test, 2 sided||||
1638338|NCT01945138|3011729|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1638339|NCT01945138|3011730|Superiority or Other|||||||0.443|||||||t-test, 2 sided||||
1638340|NCT01945138|3011731|Superiority or Other|||||||0.157|||||||t-test, 2 sided||||
1638341|NCT01945138|3011732|Superiority or Other|||||||0.205|||||||t-test, 2 sided||||
1638342|NCT01945138|3011733|Superiority or Other|||||||0.461|||||||t-test, 2 sided||||
1638343|NCT01945138|3011734|Superiority or Other|||||||0.38|||||||t-test, 2 sided||||
1638344|NCT01945138|3011735|Superiority or Other|||||||0.074|||||||t-test, 2 sided||||
1638345|NCT01945138|3011736|Superiority or Other|||||||0.848|||||||t-test, 2 sided||||
1638346|NCT01945138|3011737|Superiority or Other|||||||0.193|||||||t-test, 2 sided||||
1638347|NCT01945138|3011738|Superiority or Other|||||||0.115|||||||t-test, 2 sided||||
1638348|NCT01945138|3011739|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1638349|NCT01945034|3011754|Superiority or Other|||||||0.129|||||||Cochran-Mantel-Haenszel|p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.|||
1638597|NCT01943864|3011878|Superiority or Other||non PD rate at Week 12|15.0||||0.909|2-Sided|95.0|3.2|37.9|||Exact Binomial Test||||
1638350|NCT01945034|3011754|Superiority or Other|||||||0.279|||||||Cochran-Mantel-Haenszel|p-values from the CMH test with modified ridit scores, controlling for BLPSR and site block.|||
1638351|NCT01945034|3011754|Superiority or Other|||||||0.479|||||||Cochran-Mantel-Haenszel|p-values from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for BLPSR and site block.|||
1638352|NCT01945034|3011756|Superiority or Other||Hazard Ratio (HR)|0.34|||<|0.001|2-Sided|95.0|0.22|0.52|||Proportional Hazards Model|p-value <=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.|
1638353|NCT01945034|3011756|Superiority or Other||Hazard Ratio (HR)|0.6|||<|0.009|2-Sided|95.0|0.41|0.88|||Proportional Hazards Model|p-value <=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.|
1638354|NCT01945034|3011756|Superiority or Other||Hazard Ratio (HR)|1.79|||<|0.001|2-Sided|95.0|1.27|2.51|||Proportional Hazards Model|p-value <=0.05 for treatment effects||Time to Meaningful Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.|
1638355|NCT01945034|3011756|Superiority or Other||Hazard Ratio (HR)|0.49|||<|0.001|2-Sided|95.0|0.34|0.69|||Proportional Hazards Model|p-value <=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.|
1638356|NCT01945034|3011756|Superiority or Other||Hazard Ratio (HR)|0.71|||<|0.022|2-Sided|95.0|0.53|0.95|||Proportional Hazards Model|p-value <=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, BLPSR, and pooled site blocks.|
1638357|NCT01945034|3011756|Superiority or Other||Hazard Ratio (HR)|1.45|||<|0.016|2-Sided|95.0|1.07|1.97|||Proportional Hazards Model|p-value <=0.05 for treatment effects||Time to First Perceptible Relief: Hazard Ratio and corresponding 95% CI were calculated based on the Wald statistic from the Proportional Hazards (PH) model with treatment, BLPSR, and pooled site blocks.|
1638358|NCT01945034|3011758|Superiority or Other||LS Mean Difference|0.0||||0.733|2-Sided|95.0|-0.2|0.29|||ANOVA|p-value <=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.|
1638359|NCT01945034|3011758|Superiority or Other||LS Mean Difference|0.0||||0.853|2-Sided|95.0|-0.18|0.22|||ANOVA|p-value <=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638360|NCT01945034|3011758|Superiority or Other||LS Mean Difference|0.0||||0.833|2-Sided|95.0|-0.24|0.19|||ANOVA|p-value <=0.05 for treatment effects||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638361|NCT01945034|3011758|Superiority or Other||LS Mean Difference|-0.1||||0.598|2-Sided|95.0|-0.34|0.2|||ANOVA|p-value <=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms.|
1638362|NCT01945034|3011758|Superiority or Other||LS Mean Difference|0.2||||0.114|2-Sided|95.0|-0.04|0.4|||ANOVA|p-value <=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638363|NCT01945034|3011758|Superiority or Other||LS Mean Difference|0.2||||0.042|2-Sided|95.0|0.0|0.49|||ANOVA|p-value <=0.05 for treatment effects||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant assessment of Normal Function/Activity terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638364|NCT01945034|3011759|Superiority or Other||LS Mean Difference|-8.7||||0.849|2-Sided|95.0|-98.64|81.22|||ANOVA|p-value <=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638365|NCT01945034|3011759|Superiority or Other||LS Mean Difference|37.3||||0.325|2-Sided|95.0|-37.13|111.8|||ANOVA|p-value <=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638366|NCT01945034|3011759|Superiority or Other||LS Mean Difference|46.0||||0.261|2-Sided|95.0|-34.43|126.52|||ANOVA|p-value <=0.05 for treatment effects||Weight Bearing Over 7 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638367|NCT01945034|3011759|Superiority or Other||LS Mean Difference|-75.9||||0.072|2-Sided|95.0|-158.73|6.93|||ANOVA|||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638368|NCT01945034|3011759|Superiority or Other||LS Mean Difference|11.8||||0.735|2-Sided|95.0|-56.59|80.11|||ANOVA|p-value <=0.05 for treatment effects||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638570|NCT01944774|3011794|Superiority or Other||Odds Ratio (OR)|0.0||||0.962|2-Sided|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (<0.001, >999.999).||
1639056|NCT01942668|3012119|Superiority|||||||1|||||||Fisher Exact||||
1638369|NCT01945034|3011759|Superiority or Other||LS Mean Difference|87.7||||0.021|2-Sided|95.0|13.48|161.85|||ANOVA|p-value <=0.05 for treatment effects||At Rest Over 7 days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638370|NCT01945034|3011760|Superiority or Other||LS Mean Difference|-46.5||||0.013|2-Sided|95.0|-82.93|-10.05|||ANOVA|p-value <=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638371|NCT01945034|3011760|Superiority or Other||LS Mean Difference|-7.9||||0.603|2-Sided|95.0|-38.02|22.12|||ANOVA|p-value <=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638372|NCT01945034|3011760|Superiority or Other||LS Mean Difference|38.5||||0.021|2-Sided|95.0|5.9|71.18|||ANOVA|p-value <=0.05 for treatment effects||At Rest Over 3 Days: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638373|NCT01945034|3011761|Superiority or Other||LS Mean Difference|-9.3||||0.486|2-Sided|95.0|-35.69|17.01|||ANOVA|p-value <=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638374|NCT01945034|3011761|Superiority or Other||LS Mean Difference|4.4||||0.689|2-Sided|95.0|-17.37|26.26|||ANOVA|p-value <=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638375|NCT01945034|3011761|Superiority or Other||LS Mean Difference|13.8||||0.251|2-Sided|95.0|-9.8|37.36|||ANOVA|p-value <=0.05 for treatment effects||Weight Bearing over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638376|NCT01945034|3011761|Superiority or Other||LS Mean Difference|-5.3||||0.611|2-Sided|95.0|-25.98|15.29|||ANOVA|p-value <=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638377|NCT01945034|3011761|Superiority or Other||LS Mean Difference|-30.2||||0.018|2-Sided|95.0|-55.24|-5.23|||ANOVA|p-value <=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638378|NCT01945034|3011761|Superiority or Other||LS Mean Difference|24.9||||0.03|2-Sided|95.0|2.49|47.28|||ANOVA|p-value <=0.05 for treatment effects||At Rest over 2 Hours on Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638379|NCT01945034|3011761|Superiority or Other||LS Mean Difference|-2.2||||0.196|2-Sided|95.0|-5.64|1.16|||ANOVA|||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638380|NCT01945034|3011761|Superiority or Other||LS Mean Difference|-0.5||||0.729|2-Sided|95.0|-3.31|2.32|||ANOVA|p-value <=0.05 for treatment effects||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638381|NCT01945034|3011761|Superiority or Other||LS Mean Difference|1.7||||0.26|2-Sided|95.0|-1.3|4.79|||ANOVA|p-value <=0.05 for treatment effects||Weight Bearing over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638382|NCT01945034|3011761|Superiority or Other||LS Mean Difference|-3.8||||0.022|2-Sided|95.0|-7.04|-0.56|||ANOVA|p-value <=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638383|NCT01945034|3011761|Superiority or Other||LS Mean Difference|-1.7||||0.199|2-Sided|95.0|-4.42|0.93|||ANOVA|p-value <=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638384|NCT01945034|3011761|Superiority or Other||LS Mean Difference|2.0||||0.166|2-Sided|95.0|-0.85|4.95|||ANOVA|p-value <=0.05 for treatment effects||At Rest over 6 Hours on Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638385|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.2||||0.687|2-Sided|95.0|-0.61|0.92|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638386|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.5||||0.124|2-Sided|95.0|-0.14|1.13|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638387|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.33|2-Sided|95.0|-0.34|1.02|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638388|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.2||||0.498|2-Sided|95.0|-0.88|0.43|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638389|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.242|2-Sided|95.0|-0.22|0.87|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638390|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.5||||0.067|2-Sided|95.0|-0.04|1.14|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 7(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638391|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.845|2-Sided|95.0|-0.84|0.69|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638392|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.186|2-Sided|95.0|-0.21|1.06|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638393|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.5||||0.149|2-Sided|95.0|-0.18|1.18|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638394|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.4||||0.193|2-Sided|95.0|-1.11|0.22|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638395|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.209|2-Sided|95.0|-0.2|0.9|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638396|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.8||||0.009|2-Sided|95.0|0.2|1.39|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 7 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638397|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.458|2-Sided|95.0|-0.47|1.04|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638398|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.6||||0.073|2-Sided|95.0|-0.05|1.2|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638399|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.405|2-Sided|95.0|-0.39|0.96|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638400|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.769|2-Sided|95.0|-0.75|0.56|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638401|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.146|2-Sided|95.0|-0.14|0.94|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638402|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.5||||0.095|2-Sided|95.0|-0.09|1.09|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 7(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638403|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.46|2-Sided|95.0|-0.47|1.05|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638404|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.5||||0.126|2-Sided|95.0|-0.14|1.12|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1639057|NCT01942668|3012119|Superiority|||||||1|||||||Fisher Exact||||
1638405|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.2||||0.552|2-Sided|95.0|-0.47|0.89|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638406|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.3||||0.375|2-Sided|95.0|-0.97|0.37|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638407|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.188|2-Sided|95.0|-0.18|0.92|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638408|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.7||||0.028|2-Sided|95.0|0.07|1.27|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 6(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638409|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.375|2-Sided|95.0|-0.41|1.08|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638410|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.199|2-Sided|95.0|-0.21|1.02|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638411|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.845|2-Sided|95.0|-0.6|0.73|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638412|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.2||||0.463|2-Sided|95.0|-0.9|0.41|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638413|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.2||||0.365|2-Sided|95.0|-0.29|0.79|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638414|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.5||||0.099|2-Sided|95.0|-0.09|1.08|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 6 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638415|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.2||||0.668|2-Sided|95.0|-0.57|0.89|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638416|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.386|2-Sided|95.0|-0.34|0.87|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638417|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.747|2-Sided|95.0|-0.54|0.76|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638418|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.3||||0.422|2-Sided|95.0|-0.92|0.38|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638419|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.2||||0.505|2-Sided|95.0|-0.35|0.72|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638420|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.132|2-Sided|95.0|-0.13|1.03|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 6(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638421|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.0||||0.917|2-Sided|95.0|-0.76|0.69|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638422|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.2||||0.448|2-Sided|95.0|-0.37|0.83|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1639058|NCT01942668|3012119|Superiority|||||||0.687|||||||Fisher Exact||||
1638423|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.413|2-Sided|95.0|-0.38|0.92|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638424|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.4||||0.276|2-Sided|95.0|-1.02|0.29|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638425|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.2||||0.5|2-Sided|95.0|-0.35|0.73|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638426|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.5||||0.067|2-Sided|95.0|-0.04|1.13|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 5(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638427|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.885|2-Sided|95.0|-0.76|0.66|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638428|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.244|2-Sided|95.0|-0.24|0.94|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638429|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.215|2-Sided|95.0|-0.24|1.04|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638430|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.5||||0.131|2-Sided|95.0|-1.15|0.15|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638431|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.585|2-Sided|95.0|-0.39|0.68|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638432|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.6||||0.029|2-Sided|95.0|0.07|1.23|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 5 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638433|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.726|2-Sided|95.0|-0.82|0.57|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638434|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.2||||0.491|2-Sided|95.0|-0.37|0.78|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638435|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.304|2-Sided|95.0|-0.3|0.95|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638436|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.5||||0.13|2-Sided|95.0|-1.11|0.14|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638437|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.656|2-Sided|95.0|-0.4|0.63|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638438|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.6||||0.036|2-Sided|95.0|0.04|1.16|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 5(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638439|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.881|2-Sided|95.0|-0.65|0.76|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 4(PM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638440|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.235|2-Sided|95.0|-0.23|0.93|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638598|NCT01943864|3011879|Superiority or Other||non PD rate at Week 12|10.0||||0.976|2-Sided|95.0|1.2|31.7|||Exact Binomial Test||||
1638441|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.35|2-Sided|95.0|-0.33|0.93|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638442|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.4||||0.167|2-Sided|95.0|-1.08|0.19|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638443|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.326|2-Sided|95.0|-0.26|0.79|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638444|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.7||||0.015|2-Sided|95.0|0.14|1.28|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 4(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638445|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.2||||0.557|2-Sided|95.0|-0.91|0.49|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638446|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.712|2-Sided|95.0|-0.47|0.69|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638447|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.319|2-Sided|95.0|-0.31|0.94|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638448|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.7||||0.04|2-Sided|95.0|-1.33|-0.03|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638449|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.0||||0.987|2-Sided|95.0|-0.54|0.53|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638450|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.7||||0.023|2-Sided|95.0|0.1|1.26|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 4 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638451|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.3||||0.435|2-Sided|95.0|-0.92|0.4|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638452|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.609|2-Sided|95.0|-0.4|0.69|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638453|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.179|2-Sided|95.0|-0.19|0.99|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 4(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638454|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.7||||0.032|2-Sided|95.0|-1.25|-0.06|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638455|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.688|2-Sided|95.0|-0.59|0.39|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638456|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.6||||0.043|2-Sided|95.0|0.02|1.09|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 4(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638457|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.3||||0.448|2-Sided|95.0|-0.92|0.41|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638458|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.2||||0.586|2-Sided|95.0|-0.4|0.7|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1639059|NCT01942668|3012119|Superiority|||||||0.463|||||||Fisher Exact||||
1638459|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.177|2-Sided|95.0|-0.19|1.0|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638460|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.9||||0.006|2-Sided|95.0|-1.47|-0.25|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638461|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.2||||0.483|2-Sided|95.0|-0.69|0.33|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638462|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.7||||0.016|2-Sided|95.0|0.13|1.23|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 3(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638463|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.3||||0.348|2-Sided|95.0|-0.99|0.35|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638464|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.2||||0.533|2-Sided|95.0|-0.38|0.73|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638465|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.5||||0.105|2-Sided|95.0|-0.1|1.09|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638466|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.8||||0.01|2-Sided|95.0|-1.43|-0.2|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638467|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.763|2-Sided|95.0|-0.58|0.43|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638468|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.7||||0.009|2-Sided|95.0|0.19|1.29|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 3 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638469|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.849|2-Sided|95.0|-0.73|0.6|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638470|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.343|2-Sided|95.0|-0.29|0.82|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638471|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.276|2-Sided|95.0|-0.27|0.93|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638472|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.7||||0.039|2-Sided|95.0|-1.28|-0.03|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638473|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.0||||0.905|2-Sided|95.0|-0.48|0.54|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638474|NCT01945034|3011762|Superiority or Other||LS Mean difference|0.7||||0.016|2-Sided|95.0|0.13|1.24|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 3(AM + 2 hours): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638475|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.771|2-Sided|95.0|-0.74|0.55|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638476|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.31|2-Sided|95.0|-0.26|0.81|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 3(AM):The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638477|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.206|2-Sided|95.0|-0.21|0.95|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638478|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.6||||0.032|2-Sided|95.0|-1.23|-0.06|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638479|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.0||||0.94|2-Sided|95.0|-0.5|0.47|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638480|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.6||||0.02|2-Sided|95.0|0.1|1.15|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 3(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638481|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.0||||0.876|2-Sided|95.0|-0.67|0.58|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638482|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.2||||0.356|2-Sided|95.0|-0.27|0.76|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638483|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.304|2-Sided|95.0|-0.27|0.85|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638484|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.4||||0.208|2-Sided|95.0|-0.98|0.21|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638485|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.684|2-Sided|95.0|-0.39|0.6|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638486|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.5||||0.075|2-Sided|95.0|-0.05|1.02|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 2(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638487|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.3||||0.305|2-Sided|95.0|-0.96|0.3|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638488|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.0||||0.911|2-Sided|95.0|-0.49|0.55|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638489|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.212|2-Sided|95.0|-0.21|0.92|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638490|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.6||||0.053|2-Sided|95.0|-1.19|0.01|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638491|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.766|2-Sided|95.0|-0.57|0.42|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638492|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.5||||0.059|2-Sided|95.0|-0.02|1.05|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 2 Mid-day: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638493|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.651|2-Sided|95.0|-0.76|0.48|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638494|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.724|2-Sided|95.0|-0.6|0.42|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1639060|NCT01942668|3012120|Superiority|||||||1|||||||Fisher Exact||||
1638495|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.858|2-Sided|95.0|-0.5|0.6|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638496|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.6||||0.035|2-Sided|95.0|-1.19|-0.04|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638497|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.3||||0.277|2-Sided|95.0|-0.73|0.21|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638498|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.174|2-Sided|95.0|-0.16|0.87|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 2(AM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638499|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.3||||0.336|2-Sided|95.0|-0.94|0.32|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638500|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.727|2-Sided|95.0|-0.43|0.61|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638501|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.163|2-Sided|95.0|-0.16|0.96|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638502|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.7||||0.019|2-Sided|95.0|-1.27|-0.12|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638503|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.749|2-Sided|95.0|-0.55|0.4|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638504|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.6||||0.02|2-Sided|95.0|0.1|1.13|||ANOVA|p-value <=0.05 for treatment effects||At Rest Day 1(PM): The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638505|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.5||||0.107|2-Sided|95.0|-1.18|0.11|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638506|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.66|2-Sided|95.0|-0.42|0.65|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638507|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.7||||0.027|2-Sided|95.0|0.07|1.23|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638508|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.8||||0.015|2-Sided|95.0|-1.39|-0.15|||ANOVA|p-value <=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638509|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.715|2-Sided|95.0|-0.6|0.41|||ANOVA|p-value <=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638510|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.7||||0.017|2-Sided|95.0|0.12|1.23|||ANOVA|p-value <=0.05 for treatment effects||At Rest 6 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638511|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.5||||0.134|2-Sided|95.0|-1.18|0.16|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638512|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.0||||0.947|2-Sided|95.0|-0.57|0.53|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638513|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.5||||0.107|2-Sided|95.0|-0.11|1.09|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638514|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.7||||0.027|2-Sided|95.0|-1.33|-0.08|||ANOVA|p-value <=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638515|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.2||||0.468|2-Sided|95.0|-0.7|0.32|||ANOVA|p-value <=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638516|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.5||||0.071|2-Sided|95.0|-0.04|1.07|||ANOVA|p-value <=0.05 for treatment effects||At Rest 5 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638517|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.1||||0.78|2-Sided|95.0|-0.75|0.57|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638518|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.639|2-Sided|95.0|-0.42|0.68|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638519|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.2||||0.456|2-Sided|95.0|-0.37|0.81|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638520|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.6||||0.054|2-Sided|95.0|-1.23|0.01|||ANOVA|p-value <=0.05 for treatment effects||At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638521|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.3||||0.26|2-Sided|95.0|-0.81|0.22|||ANOVA|p-value <=0.05 for treatment effects||At Rest 4 hour Day 1:The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638522|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.264|2-Sided|95.0|-0.24|0.87|||ANOVA|p-value <=0.05 for treatment effects||At Rest 4 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638523|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.4||||0.189|2-Sided|95.0|-1.08|0.21|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638524|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.2||||0.532|2-Sided|95.0|-0.7|0.36|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638525|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.3||||0.372|2-Sided|95.0|-0.32|0.84|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638526|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.7||||0.03|2-Sided|95.0|-1.3|-0.07|||ANOVA|p-value <=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638527|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.3||||0.207|2-Sided|95.0|-0.83|0.18|||ANOVA|p-value <=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638528|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.4||||0.203|2-Sided|95.0|-0.19|0.91|||ANOVA|p-value <=0.05 for treatment effects||At Rest 3 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638529|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.3||||0.315|2-Sided|95.0|-0.9|0.29|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638530|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.3||||0.279|2-Sided|95.0|-0.77|0.22|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638531|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.0||||0.905|2-Sided|95.0|-0.5|0.57|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638532|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.5||||0.096|2-Sided|95.0|-1.07|0.09|||ANOVA|p-value <=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638533|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.4||||0.129|2-Sided|95.0|-0.85|0.11|||ANOVA|p-value <=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638534|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.644|2-Sided|95.0|-0.4|0.64|||ANOVA|p-value <=0.05 for treatment effects||At Rest 2 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638535|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.4||||0.163|2-Sided|95.0|-0.89|0.15|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms.|
1638536|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.3||||0.194|2-Sided|95.0|-0.71|0.15|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638537|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.72|2-Sided|95.0|-0.38|0.55|||ANOVA|p-value <=0.05 for treatment effects||Upon Weight Bearing 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638538|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.5||||0.032|2-Sided|95.0|-1.03|-0.05|||ANOVA|p-value <=0.05 for treatment effects||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms.|
1638539|NCT01945034|3011762|Superiority or Other||LS Mean Difference|-0.5||||0.022|2-Sided|95.0|-0.88|-0.07|||ANOVA|p-value <=0.05 for treatment effects||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638540|NCT01945034|3011762|Superiority or Other||LS Mean Difference|0.1||||0.771|2-Sided|95.0|-0.38|0.51|||ANOVA|||At Rest 1 hour Day 1: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638541|NCT01945034|3011763|Superiority or Other||LS Mean Difference|0.2||||0.18|2-Sided|95.0|-0.08|0.41||p-value <=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.|
1638542|NCT01945034|3011763|Superiority or Other||LS Mean Difference|0.0||||0.64|2-Sided|95.0|-0.25|0.15||p-value <=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638543|NCT01945034|3011763|Superiority or Other||LS Mean Difference|-0.2||||0.05|2-Sided|95.0|-0.43|0.0||p-value <=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638544|NCT01945034|3011763|Superiority or Other||LS Mean Difference|0.0||||0.871|2-Sided|95.0|-0.23|0.19||p-value <=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms.|
1638545|NCT01945034|3011763|Superiority or Other||LS Mean Difference|-0.1||||0.237|2-Sided|95.0|-0.28|0.07||p-value <=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638546|NCT01945034|3011763|Superiority or Other||LS Mean Difference|-0.1||||0.354|2-Sided|95.0|-0.27|0.1||p-value <=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline physician global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638547|NCT01945034|3011764|Superiority or Other||LS Mean Difference|-0.1||||0.534|2-Sided|95.0|-0.33|0.17||p-value <=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.|
1638548|NCT01945034|3011764|Superiority or Other||LS Mean Difference|0.1||||0.556|2-Sided|95.0|-0.14|0.27||p-value <=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638571|NCT01944774|3011794|Superiority or Other||Odds Ratio (OR)|0.0||||0.949|2-Sided|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (<0.001, >999.999).||
1638549|NCT01945034|3011764|Superiority or Other||LS Mean Difference|0.1||||0.21|2-Sided|95.0|-0.08|0.36||p-value <=0.05 for treatment effects|ANOVA|||Day 10: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638550|NCT01945034|3011764|Superiority or Other||LS Mean Difference|0.0||||0.996|2-Sided|95.0|-0.22|0.22||p-value <=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms.|
1638551|NCT01945034|3011764|Superiority or Other||LS Mean Difference|0.1||||0.261|2-Sided|95.0|-0.08|0.29||p-value <=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638552|NCT01945034|3011764|Superiority or Other||LS Mean Difference|0.1||||0.305|2-Sided|95.0|-0.1|0.3||p-value <=0.05 for treatment effects|ANOVA|||Day 3: The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site block, and baseline participant global assessment terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo|
1638553|NCT01945034|3011765|Superiority or Other||LS Mean Difference|-15.3||||0.014|2-Sided|95.0|-27.53|-3.16||p-value <=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms.|
1638554|NCT01945034|3011765|Superiority or Other||LS Mean Difference|-5.3||||0.296|2-Sided|95.0|-15.4|4.7||p-value <=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638555|NCT01945034|3011765|Superiority or Other||LS Mean Difference|10.0||||0.072|2-Sided|95.0|-0.92|20.91||p-value <=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity at rest terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638556|NCT01945034|3011766|Superiority or Other||LS Mean Difference|-5.8||||0.385|2-Sided|95.0|-18.91|7.32||p-value <=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. A comparison was eligible for being declared significant only if preceding comparison was significant.|
1638557|NCT01945034|3011766|Superiority or Other||LS Mean Difference|-1.0||||0.85|2-Sided|95.0|-11.9|9.82||p-value <=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, BLPSR, pooled site blocks, and BLPIWB terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.|
1638558|NCT01945034|3011766|Superiority or Other||Least Squares (LS) Mean Difference|4.8||||0.426|2-Sided|95.0|-6.98|16.49||p-value <=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating (BLPSR), pooled site blocks, and baseline pain intensity on weight bearing (BLPIWB) terms. 95% CI not includes 0 for treatment effect. Upper limit of 95% CI< 0 for Ibuprofen treatment significantly better than combined Placebo. Comparison: tested at the 0.05 level of significance (2-sided). A comparison was eligible for being declared significant only if preceding comparison was significant.|
1638559|NCT01945034|3011767|Superiority or Other||LS Mean Difference|-15.3||||0.436|2-Sided|95.0|-53.87|23.3||p-value <=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms.|
1638560|NCT01945034|3011767|Superiority or Other||LS Mean Difference|7.8||||0.633|2-Sided|95.0|-24.2|39.7||p-value <=0.05 for treatment effects|ANOVA|||The ANOVA model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638561|NCT01945034|3011767|Superiority or Other||LS Mean Difference|23.0||||0.19|2-Sided|95.0|-11.49|57.56||p-value <=0.05 for treatment effects|ANOVA|||The analysis of variance (ANOVA) model was used which contains treatment, baseline categorical pain severity rating, pooled site blocks, and baseline pain intensity on weight bearing terms. Upper limit of 95% CI < 0 for Ibuprofen treatment significantly better than combined Placebo.|
1638562|NCT01944774|3011790|Superiority or Other||Odds Ratio (OR)|0.567||||0.656|2-Sided|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638563|NCT01944774|3011790|Superiority or Other||Odds Ratio (OR)|0.7||||0.779|2-Sided|95.0|0.058|8.445||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638564|NCT01944774|3011791|Superiority or Other||Odds Ratio (OR)|0.567||||0.656|2-Sided|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638565|NCT01944774|3011791|Superiority or Other||Odds Ratio (OR)|0.733||||0.807|2-Sided|95.0|0.061|8.832||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638566|NCT01944774|3011792|Superiority or Other||Odds Ratio (OR)|0.567||||0.656|2-Sided|95.0|0.047|6.895||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638567|NCT01944774|3011792|Superiority or Other||Odds Ratio (OR)|0.444||||0.501|2-Sided|95.0|0.042|4.708||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638568|NCT01944774|3011793|Superiority or Other||Odds Ratio (OR)|0.531||||0.619|2-Sided|95.0|0.044|6.444||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638569|NCT01944774|3011793|Superiority or Other||Odds Ratio (OR)|0.438||||0.491|2-Sided|95.0|0.042|4.609||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638596|NCT01943864|3011863|Superiority or Other||Median PFS|10.6|||||2-Sided|95.0|4.6|12.1|||||Lower and upper limits and estimation value are in terms of weeks||
1638572|NCT01944774|3011795|Superiority or Other||Odds Ratio (OR)|0.0||||0.962|2-Sided|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (<0.001, >999.999).||
1638573|NCT01944774|3011795|Superiority or Other||Odds Ratio (OR)|0.0||||0.95|2-Sided|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (<0.001, >999.999).||
1638574|NCT01944774|3011796|Superiority or Other||Odds Ratio (OR)|0.0||||0.962|2-Sided|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (<0.001, >999.999).||
1638575|NCT01944774|3011796|Superiority or Other||Odds Ratio (OR)|0.0||||0.96|2-Sided|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (<0.001, >999.999).||
1638576|NCT01944774|3011797|Superiority or Other||Odds Ratio (OR)|0.0||||0.961|2-Sided|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (<0.001, >999.999).||
1638577|NCT01944774|3011797|Superiority or Other||Odds Ratio (OR)|0.0||||0.959|2-Sided|||||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||The 2-sided 95% confidence interval of OR is (<0.001, >999.999).||
1638578|NCT01944774|3011798|Non-Inferiority or Equivalence|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.667||||0.664|2-Sided|95.0|0.107|4.144||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638579|NCT01944774|3011798|Non-Inferiority or Equivalence|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.518||||0.458|2-Sided|95.0|0.091|2.941||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638580|NCT01944774|3011799|Non-Inferiority or Equivalence|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.508||||0.445|2-Sided|95.0|0.09|2.883||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638581|NCT01944774|3011799|Non-Inferiority or Equivalence|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.517||||0.456|2-Sided|95.0|0.091|2.93||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638582|NCT01944774|3011800|Non-Inferiority or Equivalence|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.644||||0.636|2-Sided|95.0|0.104|3.999||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638583|NCT01944774|3011800|Non-Inferiority or Equivalence|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.276||||0.118|2-Sided|95.0|0.055|1.385||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638584|NCT01944774|3011801|Non-Inferiority or Equivalence|Clinical success rate was assumed for the experimental group (Nemonoxacin 650mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.492||||0.423|2-Sided|95.0|0.087|2.788||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638585|NCT01944774|3011801|Non-Inferiority or Equivalence|Clinical success rate was assumed for the experimental group (Nemonoxacin 500mg) and the control group (Moxifloxacin 400mg) were both 88%. The non-inferiority margin was defined as 15%, one-sided significance value was 0.05 (one-tailed α=0.05), power was 80%, and the assignment ratio was 1:1:1.|Odds Ratio (OR)|0.291||||0.133|2-Sided|95.0|0.058|1.457||Only P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1638586|NCT01944631|3011824|Superiority or Other||Odds Ratio (OR)|1.1069||||0.6954|2-Sided|95.0|0.666|1.84|||Regression, Logistic||A value greater than one favours bisolviral||
1638587|NCT01944631|3011825|Superiority or Other|||||||0.1887|||||||Log Rank|Log-rank test stratifying for the variable 'baseline TSS'|||
1638588|NCT01944631|3011826|Superiority or Other||Mean Difference (Net)|0.728|Standard Error of the Mean|3.102||0.8148|2-Sided|95.0|-5.39|6.845|||ANCOVA||Difference calculated as bisolviral minus placebo||
1638589|NCT01944631|3011827|Superiority or Other||Mean Difference (Net)|-0.443|Standard Error of the Mean|0.304||0.1465|2-Sided|95.0|-1.042|0.156|||ANCOVA||Difference calculated as bisolviral minus placebo||
1638590|NCT01944631|3011828|Superiority or Other||Mean Difference (Net)|-0.176|Standard Error of the Mean|0.146||0.231|2-Sided|95.0|-0.464|0.113|||ANCOVA||Difference calculated as bisolviral minus placebo||
1638591|NCT01944631|3011829|Superiority or Other||Mean Difference (Net)|-0.613|Standard Error of the Mean|0.359||0.0895|2-Sided|95.0|-1.321|0.095|||ANCOVA||Difference calculated as bisolviral minus placebo||
1638592|NCT01943864|3011859|Superiority or Other||ORR|5.0|||||2-Sided|95.0|0.1|24.9|||||||
1638593|NCT01943864|3011860|Superiority or Other||ORR|0.0|||||2-Sided|95.0|0.0|16.8|||||||
1638594|NCT01943864|3011861|Superiority or Other||Overall Survival|20.0|||||2-Sided|95.0|6.2|39.3|||||||
1638595|NCT01943864|3011862|Superiority or Other||Median PFS|10.6|||||2-Sided|95.0|4.6|12.7|||||Lower and upper limits and estimation value are in terms of weeks||
1638599|NCT01943799|3011896|Superiority||LS Mean Difference|-0.029||||0.343|2-Sided|95.0|-0.089|0.031|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.|
1638600|NCT01943799|3011896|Superiority||LS Mean Difference|-0.007||||0.828|2-Sided|95.0|-0.067|0.053|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.|
1638601|NCT01943799|3011896|Superiority||LS Mean Difference|-0.001||||0.976|2-Sided|95.0|-0.061|0.059|||MMRM|||Each null hypothesis was tested against the 2-sided alternative that the mean change from baseline in serum HBsAg (log10 IU/mL) titers in the respective GS-4774 group was not equal to that of the OAV group. Estimated least squares means (LSM) of treatment effects and estimated differences in treatment effects between GS-4774 treatment groups and the OAV group at Week 24 were calculated with 95% confidence intervals (CIs) and unadjusted p-values.|
1638602|NCT01943552|3011914|Superiority or Other||Cochran−Mantel−Haenszel Test Statistic|1.82||||0.1779|2-Sided||||||Cochran-Mantel-Haenszel|||For main post-operative pulmonary complications, the Cochran−Mantel-Haenszel analysis was performed on the SCS. Mantel-Haenszel test with strata based on acute bronchodilator responsiveness at baseline and age was used to compare the number of patients with main post-operative pulmonary complications between the two arms.|
1638603|NCT01943552|3011915|Superiority or Other||Mean Difference (Net)|0.4|Standard Error of the Mean|0.57||0.4758|2-Sided|95.0|-0.72|1.55|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for PaCO2 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.|
1638604|NCT01943552|3011916|Superiority or Other||Mean Difference (Net)|0.4|Standard Error of the Mean|0.28||0.1899|2-Sided|95.0|-0.19|0.93|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for Oxygen saturation between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.|
1638605|NCT01943552|3011917|Superiority or Other||Mean Difference (Net)|2.8|Standard Error of the Mean|2.18||0.2069|2-Sided|95.0|-1.54|7.07|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization on treatment day 3 for PaO2 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.|
1638606|NCT01943552|3011918|Superiority or Other||Mean Difference (Net)|51.0|Standard Error of the Mean|54.48||0.3509|2-Sided|95.0|-56.55|158.46|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of forced vital capacity (FVC) from pre-bronchodilator at baseline to post-nebulization on treatment day 3 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.|
1638607|NCT01943552|3011919|Superiority or Other||Mean Difference (Net)|154.9|Standard Error of the Mean|32.32|<|0.0001|2-Sided|95.0|91.08|218.63|||ANCOVA||The Mean Difference; nebulized ipratropium minus placebo was estimated by the difference of their adjusted means.|The analysis of covariance (ANCOVA) method was used to compare the change of FEV1 from pre-bronchodilator at baseline to post-nebulization on treatment day 3 between the active arm and the placebo arm, with baseline value as covariate and two stratification factors based on acute bronchodilator responsiveness at baseline and age as main effects.|
1638608|NCT01943539|3011923|Superiority||Effect Size|0.62||||0.008|2-Sided||||||t-test, 2 sided||||
1638609|NCT01943474|3011924|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1638610|NCT01943474|3011925|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1638611|NCT01943474|3011928|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1638612|NCT01943474|3011929|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1638613|NCT01943474|3011930|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1638614|NCT01943474|3011931|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1638615|NCT01943474|3011932|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1638616|NCT01943435|3011933|Superiority||Mean Difference (Final Values)|11.8||||0.4|2-Sided|95.0|-15.6|39.1|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities >1.5 METs), while adjusting for randomization stratification factors.|
1638617|NCT01943435|3011933|Superiority||Mean Difference (Final Values)|18.7||||0.16|2-Sided|95.0|-7.6|45.0|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities >1.5 METs), while adjusting for randomization stratification factors.|
1638638|NCT01942668|3012006|Superiority||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.054||0.45|2-Sided|95.0|-0.07|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1639061|NCT01942668|3012120|Superiority|||||||1|||||||Fisher Exact||||
1638618|NCT01943435|3011933|Superiority||Mean Difference (Final Values)|30.5||||0.03|2-Sided|95.0|3.1|57.9|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This secondary analysis consisted of a between-groups comparison of means using linear regression with physical activity as the dependent variable (average number of minutes spent daily in activities >1.5 METs), while adjusting for randomization stratification factors.|
1638619|NCT01943435|3011934|Superiority||Mean Difference (Final Values)|-42.7||||0.61|2-Sided|95.0|-205.4|120.0|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.|
1638620|NCT01943435|3011934|Superiority||Mean Difference (Final Values)|129.7||||0.1|2-Sided|95.0|-27.2|286.6|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.|
1638621|NCT01943435|3011934|Superiority||Mean Difference (Final Values)|87.0||||0.29|2-Sided|95.0|-75.2|249.2|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||This analysis consisted of a between-groups comparison of means using linear mixed models with SPWT as the dependent variable, while adjusting for randomization stratification factors.|
1638622|NCT01943435|3011935|Superiority|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|2.4||||0.01|2-Sided|95.0|0.6|4.3|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.|
1638623|NCT01943435|3011935|Superiority|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|-2.1||||0.02|2-Sided|95.0|-3.9|-0.3|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.|
1638624|NCT01943435|3011935|Superiority|For this superiority study, sample size estimation was based upon hypothesized changes in our primary outcome measure, the Swiss Spinal Stenosis (SSS) questionnaire. We calculated that a total sample size of 180 subjects (n=60 per group) would give us 80% power to detect a difference as small as 3.6 points on the Swiss Spinal Stenosis questionnaire score. Sample size was increased at the request of the funding agency without any interim analysis performed.|Mean Difference (Final Values)|0.3||||0.73|2-Sided|95.0|-1.5|2.2|||Regression, Linear|Linear mixed models were adjusted for randomization stratification factors.||The primary analysis was a between-groups comparison of means using linear mixed models with SSS total score as the dependent variable, while adjusting for randomization stratification factors.|
1638625|NCT01942720|3011999|Superiority or Other||Sperman correlation coefficient|0.785|||<|0.001|2-Sided||||||Sperman correlation|||Relationship of PillCam total SB CECDEIS score change with TI Leis score change from baseline visit to 6 month follow-up|
1638626|NCT01942720|3011999|Superiority or Other||Sperman correlation coefficient|0.752|||<|0.001|2-Sided||||||Sperman correlation|||Relationship of PillCam total SB Lewis score change with TI Leis score change from baseline visit to 6 month follow-up|
1638627|NCT01942720|3012000|Superiority or Other||Sperman correlation coefficient|0.531|||<|0.001|2-Sided||||||Sperman correlation|||Relationship of PillCam SB CECDEIS score with TI SES-CD score change from baseline visit to 6 month follow-up|
1638628|NCT01942720|3012000|Superiority or Other||Sperman correlation coefficient|0.493|||<|0.002|2-Sided||||||Sperman correlation|||Relationship of PillCam SB Lewis score with TI SES-CD score change from baseline visit to 6 month follow-up|
1638629|NCT01942720|3012001|Superiority or Other||Sperman correlation coefficient|0.726|||<|0.001|2-Sided||||||Sperman correlation|||Relationship of PillCam SB TI CECDEIS scores with TI SES-CD score at baseline visit|
1638630|NCT01942720|3012001|Superiority or Other||Sperman correlation coefficient|0.735|||<|0.001|2-Sided||||||Sperman correlation|||Relationship of PillCam SB TI Lewis scores with TI SES-CD score at baseline visit|
1638631|NCT01942720|3012002|Superiority or Other||Sperman correlation coeficient|0.022||||0.882|2-Sided||||||Sperman correlation|||Relationship of total PillCam SB CECDEIS score with PGA score change from baseline visit to 6 month follow-up|
1638632|NCT01942720|3012002|Superiority or Other||Sperman correlation coeficient|-0.7||||0.631|2-Sided||||||Sperman test|||Relationship of total PillCam SB Lewis score with PGA score change from baseline visit to 6 month follow-up|
1638633|NCT01942707|3012003|Superiority||Mean Difference (Final Values)|4.8|Standard Deviation|40.7||0.809|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1638634|NCT01942707|3012004|Superiority||Mean Difference (Final Values)|1.2|Standard Deviation|1.9||0.012|2-Sided|95.0|||||t-test, 2 sided||||
1638635|NCT01942707|3012005|Superiority||Mean Difference (Final Values)|179.0|Standard Deviation|222.0||0.003|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1638636|NCT01942668|3012006|Superiority||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.055||0.309|2-Sided|95.0|-0.16|0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638637|NCT01942668|3012006|Superiority||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.054||0.663|2-Sided|95.0|-0.13|0.08||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1639062|NCT01942668|3012120|Superiority|||||||0.536|||||||Fisher Exact||||
1639063|NCT01942668|3012120|Superiority|||||||0.261|||||||Fisher Exact||||
1638639|NCT01942668|3012006|Superiority||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.055||0.992|2-Sided|95.0|-0.11|0.11||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638640|NCT01942668|3012007|Superiority||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.052||0.907|2-Sided|95.0|-0.1|0.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638641|NCT01942668|3012007|Superiority||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.052||0.126|2-Sided|95.0|-0.02|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638642|NCT01942668|3012007|Superiority||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.052||0.069|2-Sided|95.0|-0.01|0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638643|NCT01942668|3012007|Superiority||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.052||0.045|2-Sided|95.0|0.0|0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638644|NCT01942668|3012008|Superiority||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.049||0.69|2-Sided|95.0|-0.11|0.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638645|NCT01942668|3012008|Superiority||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.049||0.414|2-Sided|95.0|-0.06|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638646|NCT01942668|3012008|Superiority||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.049||0.741|2-Sided|95.0|-0.08|0.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638647|NCT01942668|3012008|Superiority||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.049||0.225|2-Sided|95.0|-0.04|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638648|NCT01942668|3012009|Superiority||Mean Difference (Final Values)|-6.54|Standard Error of the Mean|1.851|<|0.001|2-Sided|95.0|-10.17|-2.91||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638649|NCT01942668|3012009|Superiority||Mean Difference (Final Values)|-7.43|Standard Error of the Mean|1.828|<|0.001|2-Sided|95.0|-11.02|-3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638650|NCT01942668|3012009|Superiority||Mean Difference (Final Values)|-7.58|Standard Error of the Mean|1.835|<|0.001|2-Sided|95.0|-11.18|-3.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638651|NCT01942668|3012009|Superiority||Mean Difference (Final Values)|-6.28|Standard Error of the Mean|1.849|<|0.001|2-Sided|95.0|-9.91|-2.65||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638652|NCT01942668|3012010|Superiority||Mean Difference (Final Values)|-4.64|Standard Error of the Mean|1.677||0.006|2-Sided|95.0|-7.93|-1.35||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638653|NCT01942668|3012010|Superiority||Mean Difference (Final Values)|-5.12|Standard Error of the Mean|1.667||0.002|2-Sided|95.0|-8.39|-1.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638654|NCT01942668|3012010|Superiority||Mean Difference (Final Values)|-5.53|Standard Error of the Mean|1.674|<|0.001|2-Sided|95.0|-8.81|-2.25||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638655|NCT01942668|3012010|Superiority||Mean Difference (Final Values)|-5.44|Standard Error of the Mean|1.682|<|0.001|2-Sided|95.0|-8.74|-2.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638656|NCT01942668|3012011|Superiority||Mean Difference (Final Values)|-2.48|Standard Error of the Mean|1.597||0.121|2-Sided|95.0|-5.61|0.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638657|NCT01942668|3012011|Superiority||Mean Difference (Final Values)|-3.15|Standard Error of the Mean|1.598||0.049|2-Sided|95.0|-6.29|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638658|NCT01942668|3012011|Superiority||Mean Difference (Final Values)|-3.49|Standard Error of the Mean|1.605||0.03|2-Sided|95.0|-6.64|-0.34||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638659|NCT01942668|3012011|Superiority||Mean Difference (Final Values)|-4.6|Standard Error of the Mean|1.609||0.004|2-Sided|95.0|-7.75|-1.44||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638660|NCT01942668|3012012|Superiority||Mean Difference (Final Values)|-6.42|Standard Error of the Mean|1.886|<|0.001|2-Sided|95.0|-10.12|-2.72||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638661|NCT01942668|3012012|Superiority||Mean Difference (Final Values)|-6.92|Standard Error of the Mean|1.863|<|0.001|2-Sided|95.0|-10.58|-3.27||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638662|NCT01942668|3012012|Superiority||Mean Difference (Final Values)|-7.22|Standard Error of the Mean|1.871|<|0.001|2-Sided|95.0|-10.89|-3.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638663|NCT01942668|3012012|Superiority||Mean Difference (Final Values)|-6.01|Standard Error of the Mean|1.885|<|0.001|2-Sided|95.0|-9.71|-2.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638664|NCT01942668|3012013|Superiority||Mean Difference (Final Values)|-5.11|Standard Error of the Mean|1.708||0.003|2-Sided|95.0|-8.46|-1.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638665|NCT01942668|3012013|Superiority||Mean Difference (Final Values)|-5.12|Standard Error of the Mean|1.697||0.003|2-Sided|95.0|-8.45|-1.79||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638666|NCT01942668|3012013|Superiority||Mean Difference (Final Values)|-5.58|Standard Error of the Mean|1.704||0.001|2-Sided|95.0|-8.93|-2.24||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638667|NCT01942668|3012013|Superiority||Mean Difference (Final Values)|-5.69|Standard Error of the Mean|1.713|<|0.001|2-Sided|95.0|-9.05|-2.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638668|NCT01942668|3012014|Superiority||Mean Difference (Final Values)|-3.41|Standard Error of the Mean|1.652||0.039|2-Sided|95.0|-6.65|-0.17||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638669|NCT01942668|3012014|Superiority||Mean Difference (Final Values)|-3.28|Standard Error of the Mean|1.653||0.047|2-Sided|95.0|-6.52|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638670|NCT01942668|3012014|Superiority||Mean Difference (Final Values)|-3.79|Standard Error of the Mean|1.66||0.023|2-Sided|95.0|-7.05|-0.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638671|NCT01942668|3012014|Superiority||Mean Difference (Final Values)|-4.92|Standard Error of the Mean|1.665||0.003|2-Sided|95.0|-8.18|-1.65||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638672|NCT01942668|3012015|Superiority||Mean Difference (Final Values)|-3.88|Standard Error of the Mean|2.029||0.056|2-Sided|95.0|-7.86|0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638673|NCT01942668|3012015|Superiority||Mean Difference (Final Values)|-4.94|Standard Error of the Mean|2.003||0.014|2-Sided|95.0|-8.87|-1.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638674|NCT01942668|3012015|Superiority||Mean Difference (Final Values)|-5.34|Standard Error of the Mean|2.01||0.008|2-Sided|95.0|-9.28|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638675|NCT01942668|3012015|Superiority||Mean Difference (Final Values)|-3.36|Standard Error of the Mean|2.026||0.097|2-Sided|95.0|-7.34|0.61||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638676|NCT01942668|3012016|Superiority||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|1.919||0.949|2-Sided|95.0|-3.89|3.64||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638677|NCT01942668|3012016|Superiority||Mean Difference (Final Values)|-1.42|Standard Error of the Mean|1.907||0.456|2-Sided|95.0|-5.16|2.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638678|NCT01942668|3012016|Superiority||Mean Difference (Final Values)|-1.14|Standard Error of the Mean|1.914||0.553|2-Sided|95.0|-4.89|2.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638679|NCT01942668|3012016|Superiority||Mean Difference (Final Values)|-1.09|Standard Error of the Mean|1.924||0.572|2-Sided|95.0|-4.86|2.69||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638680|NCT01942668|3012017|Superiority||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|1.736||0.696|2-Sided|95.0|-4.08|2.72||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638681|NCT01942668|3012017|Superiority||Mean Difference (Final Values)|0.14|Standard Error of the Mean|1.737||0.936|2-Sided|95.0|-3.27|3.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638682|NCT01942668|3012017|Superiority||Mean Difference (Final Values)|-1.18|Standard Error of the Mean|1.743||0.499|2-Sided|95.0|-4.6|2.24||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638683|NCT01942668|3012017|Superiority||Mean Difference (Final Values)|-1.64|Standard Error of the Mean|1.749||0.349|2-Sided|95.0|-5.07|1.79||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638684|NCT01942668|3012018|Superiority||Mean Difference (Final Values)|7.89|Standard Error of the Mean|2.944||0.007|2-Sided|95.0|2.11|13.67||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638685|NCT01942668|3012018|Superiority||Mean Difference (Final Values)|7.65|Standard Error of the Mean|2.911||0.009|2-Sided|95.0|1.94|13.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638686|NCT01942668|3012018|Superiority||Mean Difference (Final Values)|7.56|Standard Error of the Mean|2.92||0.01|2-Sided|95.0|1.83|13.29||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638687|NCT01942668|3012018|Superiority||Mean Difference (Final Values)|5.02|Standard Error of the Mean|2.945||0.089|2-Sided|95.0|-0.76|10.8||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1639064|NCT01942668|3012121|Superiority|||||||1|||||||Fisher Exact||||
1639065|NCT01942668|3012121|Superiority|||||||1|||||||Fisher Exact||||
1638688|NCT01942668|3012019|Superiority||Mean Difference (Final Values)|8.38|Standard Error of the Mean|2.638||0.002|2-Sided|95.0|3.2|13.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638689|NCT01942668|3012019|Superiority||Mean Difference (Final Values)|5.9|Standard Error of the Mean|2.623||0.025|2-Sided|95.0|0.75|11.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638690|NCT01942668|3012019|Superiority||Mean Difference (Final Values)|7.1|Standard Error of the Mean|2.634||0.007|2-Sided|95.0|1.93|12.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638691|NCT01942668|3012019|Superiority||Mean Difference (Final Values)|5.11|Standard Error of the Mean|2.647||0.054|2-Sided|95.0|-0.08|10.31||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638692|NCT01942668|3012020|Superiority||Mean Difference (Final Values)|3.48|Standard Error of the Mean|2.492||0.163|2-Sided|95.0|-1.41|8.37||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638693|NCT01942668|3012020|Superiority||Mean Difference (Final Values)|3.72|Standard Error of the Mean|2.496||0.136|2-Sided|95.0|-1.17|8.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638694|NCT01942668|3012020|Superiority||Mean Difference (Final Values)|2.61|Standard Error of the Mean|2.506||0.298|2-Sided|95.0|-2.3|7.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638695|NCT01942668|3012020|Superiority||Mean Difference (Final Values)|4.35|Standard Error of the Mean|2.513||0.084|2-Sided|95.0|-0.58|9.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638696|NCT01942668|3012021|Superiority||Mean Difference (Final Values)|-1.68|Standard Error of the Mean|2.277||0.46|2-Sided|95.0|-6.15|2.78||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638697|NCT01942668|3012021|Superiority||Mean Difference (Final Values)|-1.51|Standard Error of the Mean|2.25||0.504|2-Sided|95.0|-5.92|2.91||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638698|NCT01942668|3012021|Superiority||Mean Difference (Final Values)|-2.43|Standard Error of the Mean|2.253||0.281|2-Sided|95.0|-6.85|1.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638699|NCT01942668|3012021|Superiority||Mean Difference (Final Values)|-1.96|Standard Error of the Mean|2.274||0.389|2-Sided|95.0|-6.42|2.5||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638700|NCT01942668|3012022|Superiority||Mean Difference (Final Values)|-1.47|Standard Error of the Mean|2.161||0.495|2-Sided|95.0|-5.71|2.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638701|NCT01942668|3012022|Superiority||Mean Difference (Final Values)|-1.44|Standard Error of the Mean|2.148||0.502|2-Sided|95.0|-5.66|2.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638702|NCT01942668|3012022|Superiority||Mean Difference (Final Values)|-2.27|Standard Error of the Mean|2.154||0.293|2-Sided|95.0|-6.49|1.96||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638703|NCT01942668|3012022|Superiority||Mean Difference (Final Values)|-2.46|Standard Error of the Mean|2.166||0.255|2-Sided|95.0|-6.71|1.78||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638704|NCT01942668|3012023|Superiority||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|2.043||0.823|2-Sided|95.0|-4.46|3.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638705|NCT01942668|3012023|Superiority||Mean Difference (Final Values)|0.51|Standard Error of the Mean|2.046||0.802|2-Sided|95.0|-3.5|4.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638706|NCT01942668|3012023|Superiority||Mean Difference (Final Values)|-0.64|Standard Error of the Mean|2.05||0.755|2-Sided|95.0|-4.66|3.38||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638707|NCT01942668|3012023|Superiority||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|2.058||0.83|2-Sided|95.0|-4.48|3.59||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638708|NCT01942668|3012024|Superiority||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|2.867||0.893|2-Sided|95.0|-6.01|5.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638709|NCT01942668|3012024|Superiority||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|2.827||0.877|2-Sided|95.0|-5.98|5.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638710|NCT01942668|3012024|Superiority||Mean Difference (Final Values)|-1.35|Standard Error of the Mean|2.834||0.635|2-Sided|95.0|-6.91|4.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638711|NCT01942668|3012024|Superiority||Mean Difference (Final Values)|1.25|Standard Error of the Mean|2.863||0.662|2-Sided|95.0|-4.36|6.87||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638986|NCT01942668|3012097|Superiority|||||||0.135||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact||||
1638712|NCT01942668|3012025|Superiority||Mean Difference (Final Values)|-1.17|Standard Error of the Mean|2.708||0.667|2-Sided|95.0|-6.48|4.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638713|NCT01942668|3012025|Superiority||Mean Difference (Final Values)|-3.68|Standard Error of the Mean|2.691||0.171|2-Sided|95.0|-8.96|1.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638714|NCT01942668|3012025|Superiority||Mean Difference (Final Values)|-1.65|Standard Error of the Mean|2.699||0.541|2-Sided|95.0|-6.95|3.64||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638715|NCT01942668|3012025|Superiority||Mean Difference (Final Values)|0.25|Standard Error of the Mean|2.719||0.927|2-Sided|95.0|-5.08|5.58||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638716|NCT01942668|3012026|Superiority||Mean Difference (Final Values)|1.59|Standard Error of the Mean|2.555||0.534|2-Sided|95.0|-3.42|6.6||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638717|NCT01942668|3012026|Superiority||Mean Difference (Final Values)|1.5|Standard Error of the Mean|2.558||0.558|2-Sided|95.0|-3.52|6.51||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638718|NCT01942668|3012026|Superiority||Mean Difference (Final Values)|1.97|Standard Error of the Mean|2.564||0.442|2-Sided|95.0|-3.06|7.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638719|NCT01942668|3012026|Superiority||Mean Difference (Final Values)|2.02|Standard Error of the Mean|2.576||0.434|2-Sided|95.0|-3.03|7.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638720|NCT01942668|3012027|Superiority||Mean Difference (Final Values)|-7.72|Standard Error of the Mean|2.442||0.002|2-Sided|95.0|-12.51|-2.93||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638721|NCT01942668|3012027|Superiority||Mean Difference (Final Values)|-9.3|Standard Error of the Mean|2.412|<|0.001|2-Sided|95.0|-14.03|-4.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638722|NCT01942668|3012027|Superiority||Mean Difference (Final Values)|-9.6|Standard Error of the Mean|2.42|<|0.001|2-Sided|95.0|-14.34|-4.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638723|NCT01942668|3012027|Superiority||Mean Difference (Final Values)|-8.97|Standard Error of the Mean|2.439|<|0.001|2-Sided|95.0|-13.76|-4.19||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638724|NCT01942668|3012028|Superiority||Mean Difference (Final Values)|-5.6|Standard Error of the Mean|2.207||0.011|2-Sided|95.0|-9.93|-1.27||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638725|NCT01942668|3012028|Superiority||Mean Difference (Final Values)|-7.32|Standard Error of the Mean|2.193|<|0.001|2-Sided|95.0|-11.63|-3.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638726|NCT01942668|3012028|Superiority||Mean Difference (Final Values)|-7.52|Standard Error of the Mean|2.201|<|0.001|2-Sided|95.0|-11.83|-3.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638727|NCT01942668|3012028|Superiority||Mean Difference (Final Values)|-8.38|Standard Error of the Mean|2.213|<|0.001|2-Sided|95.0|-12.72|-4.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638728|NCT01942668|3012029|Superiority||Mean Difference (Final Values)|-3.04|Standard Error of the Mean|2.13||0.154|2-Sided|95.0|-7.22|1.14||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638729|NCT01942668|3012029|Superiority||Mean Difference (Final Values)|-5.13|Standard Error of the Mean|2.132||0.016|2-Sided|95.0|-9.31|-0.95||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638730|NCT01942668|3012029|Superiority||Mean Difference (Final Values)|-5.6|Standard Error of the Mean|2.139||0.009|2-Sided|95.0|-9.8|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638731|NCT01942668|3012029|Superiority||Mean Difference (Final Values)|-7.34|Standard Error of the Mean|2.146|<|0.001|2-Sided|95.0|-11.55|-3.13||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638732|NCT01942668|3012030|Superiority||Mean Difference (Final Values)|-6.76|Standard Error of the Mean|1.863|<|0.001|2-Sided|95.0|-10.41|-3.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638733|NCT01942668|3012030|Superiority||Mean Difference (Final Values)|-7.44|Standard Error of the Mean|1.835|<|0.001|2-Sided|95.0|-11.04|-3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638734|NCT01942668|3012030|Superiority||Mean Difference (Final Values)|-7.61|Standard Error of the Mean|1.843|<|0.001|2-Sided|95.0|-11.23|-4.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638735|NCT01942668|3012030|Superiority||Mean Difference (Final Values)|-6.54|Standard Error of the Mean|1.855|<|0.001|2-Sided|95.0|-10.18|-2.9||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638987|NCT01942668|3012097|Superiority|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact||||
1638736|NCT01942668|3012031|Superiority||Mean Difference (Final Values)|-4.42|Standard Error of the Mean|1.698||0.009|2-Sided|95.0|-7.75|-1.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638737|NCT01942668|3012031|Superiority||Mean Difference (Final Values)|-4.88|Standard Error of the Mean|1.685||0.004|2-Sided|95.0|-8.19|-1.58||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638738|NCT01942668|3012031|Superiority||Mean Difference (Final Values)|-5.39|Standard Error of the Mean|1.696||0.002|2-Sided|95.0|-8.72|-2.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638739|NCT01942668|3012031|Superiority||Mean Difference (Final Values)|-5.39|Standard Error of the Mean|1.7||0.002|2-Sided|95.0|-8.73|-2.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638740|NCT01942668|3012032|Superiority||Mean Difference (Final Values)|-2.53|Standard Error of the Mean|1.621||0.119|2-Sided|95.0|-5.71|0.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638741|NCT01942668|3012032|Superiority||Mean Difference (Final Values)|-3.44|Standard Error of the Mean|1.618||0.034|2-Sided|95.0|-6.61|-0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638742|NCT01942668|3012032|Superiority||Mean Difference (Final Values)|-3.61|Standard Error of the Mean|1.626||0.027|2-Sided|95.0|-6.8|-0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638743|NCT01942668|3012032|Superiority||Mean Difference (Final Values)|-4.88|Standard Error of the Mean|1.629||0.003|2-Sided|95.0|-8.08|-1.69||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638744|NCT01942668|3012033|Superiority||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.13||0.006|2-Sided|95.0|-0.63|-0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638745|NCT01942668|3012033|Superiority||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.13|<|0.001|2-Sided|95.0|-0.73|-0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638746|NCT01942668|3012033|Superiority||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.13|<|0.001|2-Sided|95.0|-0.88|-0.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638747|NCT01942668|3012033|Superiority||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.13|<|0.001|2-Sided|95.0|-0.89|-0.36||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638748|NCT01942668|3012034|Superiority||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.12||0.03|2-Sided|95.0|-0.5|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638749|NCT01942668|3012034|Superiority||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|0.12||0.003|2-Sided|95.0|-0.59|-0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638750|NCT01942668|3012034|Superiority||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|-0.69|-0.22||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638751|NCT01942668|3012034|Superiority||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|-0.85|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638752|NCT01942668|3012035|Superiority||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|-0.64|-0.2||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638753|NCT01942668|3012035|Superiority||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|-0.75|-0.3||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638754|NCT01942668|3012035|Superiority||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|-0.71|-0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638755|NCT01942668|3012035|Superiority||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|-0.85|-0.4||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638756|NCT01942668|3012036|Superiority||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.202||0.223|2-Sided|95.0|-0.64|0.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638757|NCT01942668|3012036|Superiority||Mean Difference (Final Values)|-0.33|Standard Error of the Mean|0.199||0.093|2-Sided|95.0|-0.72|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638758|NCT01942668|3012036|Superiority||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.199||0.026|2-Sided|95.0|-0.84|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638759|NCT01942668|3012036|Superiority||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|0.201||0.029|2-Sided|95.0|-0.84|-0.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638760|NCT01942668|3012037|Superiority||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.176||0.829|2-Sided|95.0|-0.38|0.31||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1639066|NCT01942668|3012121|Superiority|||||||0.536|||||||Fisher Exact||||
1638761|NCT01942668|3012037|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.175||0.345|2-Sided|95.0|-0.51|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638762|NCT01942668|3012037|Superiority||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.175||0.212|2-Sided|95.0|-0.56|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638763|NCT01942668|3012037|Superiority||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.177||0.081|2-Sided|95.0|-0.65|0.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638764|NCT01942668|3012038|Superiority||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.169||0.156|2-Sided|95.0|-0.57|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638765|NCT01942668|3012038|Superiority||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.169||0.106|2-Sided|95.0|-0.6|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638766|NCT01942668|3012038|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.169||0.302|2-Sided|95.0|-0.51|0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638767|NCT01942668|3012038|Superiority||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.17||0.107|2-Sided|95.0|-0.61|0.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638768|NCT01942668|3012039|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.138||0.23|2-Sided|95.0|-0.44|0.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638769|NCT01942668|3012039|Superiority||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.136||0.097|2-Sided|95.0|-0.49|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638770|NCT01942668|3012039|Superiority||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.137||0.026|2-Sided|95.0|-0.57|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638771|NCT01942668|3012039|Superiority||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.138||0.06|2-Sided|95.0|-0.53|0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638772|NCT01942668|3012040|Superiority||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.124||0.607|2-Sided|95.0|-0.31|0.18||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638773|NCT01942668|3012040|Superiority||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.123||0.435|2-Sided|95.0|-0.34|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638774|NCT01942668|3012040|Superiority||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.124||0.279|2-Sided|95.0|-0.38|0.11||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638775|NCT01942668|3012040|Superiority||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.124||0.056|2-Sided|95.0|-0.48|0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638776|NCT01942668|3012041|Superiority||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.115||0.323|2-Sided|95.0|-0.34|0.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638777|NCT01942668|3012041|Superiority||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.115||0.014|2-Sided|95.0|-0.51|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638778|NCT01942668|3012041|Superiority||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.116||0.108|2-Sided|95.0|-0.41|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638779|NCT01942668|3012041|Superiority||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.116||0.181|2-Sided|95.0|-0.38|0.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638780|NCT01942668|3012042|Superiority||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.153||0.854|2-Sided|95.0|-0.33|0.27||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638781|NCT01942668|3012042|Superiority||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.151||0.55|2-Sided|95.0|-0.39|0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638782|NCT01942668|3012042|Superiority||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.151||0.058|2-Sided|95.0|-0.58|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638783|NCT01942668|3012042|Superiority||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.152||0.153|2-Sided|95.0|-0.52|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638784|NCT01942668|3012043|Superiority||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.138||0.424|2-Sided|95.0|-0.38|0.16||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638785|NCT01942668|3012043|Superiority||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.137||0.384|2-Sided|95.0|-0.39|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1639067|NCT01942668|3012121|Superiority|||||||0.035|||||||Fisher Exact||||
1639068|NCT01942668|3012122|Superiority|||||||1|||||||Fisher Exact||||
1638786|NCT01942668|3012043|Superiority||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.138||0.045|2-Sided|95.0|-0.55|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638787|NCT01942668|3012043|Superiority||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.138||0.023|2-Sided|95.0|-0.59|-0.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638788|NCT01942668|3012044|Superiority||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.13||0.358|2-Sided|95.0|-0.37|0.14||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638789|NCT01942668|3012044|Superiority||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.13||0.222|2-Sided|95.0|-0.41|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638790|NCT01942668|3012044|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.13||0.2|2-Sided|95.0|-0.42|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638791|NCT01942668|3012044|Superiority||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.131||0.126|2-Sided|95.0|-0.46|0.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638792|NCT01942668|3012045|Superiority||Mean Difference (Final Values)|-1.08|Standard Error of the Mean|0.207|<|0.001|2-Sided|95.0|-1.48|-0.67||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638793|NCT01942668|3012045|Superiority||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|0.205|<|0.001|2-Sided|95.0|-1.7|-0.9||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638794|NCT01942668|3012045|Superiority||Mean Difference (Final Values)|-1.47|Standard Error of the Mean|0.204|<|0.001|2-Sided|95.0|-1.87|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638795|NCT01942668|3012045|Superiority||Mean Difference (Final Values)|-1.65|Standard Error of the Mean|0.207|<|0.001|2-Sided|95.0|-2.06|-1.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638796|NCT01942668|3012046|Superiority||Mean Difference (Final Values)|-0.96|Standard Error of the Mean|0.198|<|0.001|2-Sided|95.0|-1.34|-0.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638797|NCT01942668|3012046|Superiority||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.197|<|0.001|2-Sided|95.0|-1.58|-0.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638798|NCT01942668|3012046|Superiority||Mean Difference (Final Values)|-1.29|Standard Error of the Mean|0.197|<|0.001|2-Sided|95.0|-1.68|-0.91||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638799|NCT01942668|3012046|Superiority||Mean Difference (Final Values)|-1.73|Standard Error of the Mean|0.199|<|0.001|2-Sided|95.0|-2.12|-1.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638800|NCT01942668|3012047|Superiority||Mean Difference (Final Values)|-1.25|Standard Error of the Mean|0.188|<|0.001|2-Sided|95.0|-1.62|-0.88||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638801|NCT01942668|3012047|Superiority||Mean Difference (Final Values)|-1.44|Standard Error of the Mean|0.189|<|0.001|2-Sided|95.0|-1.81|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638802|NCT01942668|3012047|Superiority||Mean Difference (Final Values)|-1.44|Standard Error of the Mean|0.189|<|0.001|2-Sided|95.0|-1.81|-1.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638803|NCT01942668|3012047|Superiority||Mean Difference (Final Values)|-1.92|Standard Error of the Mean|0.19|<|0.001|2-Sided|95.0|-2.29|-1.55||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638804|NCT01942668|3012048|Superiority||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.065||0.527|2-Sided|95.0|-0.17|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638805|NCT01942668|3012048|Superiority||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.065||0.354|2-Sided|95.0|-0.19|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638806|NCT01942668|3012048|Superiority||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.064||0.244|2-Sided|95.0|-0.05|0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638807|NCT01942668|3012048|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.067||0.452|2-Sided|95.0|-0.18|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638808|NCT01942668|3012049|Superiority||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.062||0.851|2-Sided|95.0|-0.11|0.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638809|NCT01942668|3012049|Superiority||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.063||0.37|2-Sided|95.0|-0.07|0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638810|NCT01942668|3012049|Superiority||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.062||0.074|2-Sided|95.0|-0.01|0.23||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1639069|NCT01942668|3012122|Superiority|||||||0.745|||||||Fisher Exact||||
1638811|NCT01942668|3012049|Superiority||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.063||0.075|2-Sided|95.0|-0.01|0.24||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638812|NCT01942668|3012050|Superiority||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.058||0.421|2-Sided|95.0|-0.07|0.16||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638813|NCT01942668|3012050|Superiority||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.059||0.646|2-Sided|95.0|-0.14|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638814|NCT01942668|3012050|Superiority||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.059||0.779|2-Sided|95.0|-0.1|0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638815|NCT01942668|3012050|Superiority||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.06||0.938|2-Sided|95.0|-0.12|0.11||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638816|NCT01942668|3012051|Superiority||Mean Difference (Final Values)|-6.78|Standard Error of the Mean|2.381||0.005|2-Sided|95.0|-11.46|-2.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638817|NCT01942668|3012051|Superiority||Mean Difference (Final Values)|-7.92|Standard Error of the Mean|2.384|<|0.001|2-Sided|95.0|-12.6|-3.23||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638818|NCT01942668|3012051|Superiority||Mean Difference (Final Values)|-7.36|Standard Error of the Mean|2.317|<|0.002|2-Sided|95.0|-11.91|-2.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638819|NCT01942668|3012051|Superiority||Mean Difference (Final Values)|-4.21|Standard Error of the Mean|2.421|<|0.083|2-Sided|95.0|-8.96|0.55||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638820|NCT01942668|3012052|Superiority||Mean Difference (Final Values)|-5.32|Standard Error of the Mean|2.078||0.011|2-Sided|95.0|-9.4|-1.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638821|NCT01942668|3012052|Superiority||Mean Difference (Final Values)|-5.74|Standard Error of the Mean|2.115||0.007|2-Sided|95.0|-9.9|-1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638822|NCT01942668|3012052|Superiority||Mean Difference (Final Values)|-5.54|Standard Error of the Mean|2.065||0.008|2-Sided|95.0|-9.6|-1.48||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638823|NCT01942668|3012052|Superiority||Mean Difference (Final Values)|-5.41|Standard Error of the Mean|2.119||0.011|2-Sided|95.0|-9.57|-1.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638824|NCT01942668|3012053|Superiority||Mean Difference (Final Values)|-2.22|Standard Error of the Mean|1.973||0.262|2-Sided|95.0|-6.09|1.66||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638825|NCT01942668|3012053|Superiority||Mean Difference (Final Values)|-4.37|Standard Error of the Mean|2.012||0.03|2-Sided|95.0|-8.32|-0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638826|NCT01942668|3012053|Superiority||Mean Difference (Final Values)|-2.39|Standard Error of the Mean|1.997||0.232|2-Sided|95.0|-6.31|1.53||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638827|NCT01942668|3012053|Superiority||Mean Difference (Final Values)|-4.21|Standard Error of the Mean|2.037||0.039|2-Sided|95.0|-8.21|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638828|NCT01942668|3012054|Superiority||Mean Difference (Final Values)|-6.69|Standard Error of the Mean|2.429||0.006|2-Sided|95.0|-11.46|-1.92||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638829|NCT01942668|3012054|Superiority||Mean Difference (Final Values)|-7.39|Standard Error of the Mean|2.434||0.003|2-Sided|95.0|-12.17|-2.61||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638830|NCT01942668|3012054|Superiority||Mean Difference (Final Values)|-6.49|Standard Error of the Mean|2.364||0.006|2-Sided|95.0|-11.14|-1.85||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638831|NCT01942668|3012054|Superiority||Mean Difference (Final Values)|-3.39|Standard Error of the Mean|2.47||0.171|2-Sided|95.0|-8.24|1.47||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638832|NCT01942668|3012055|Superiority||Mean Difference (Final Values)|-5.68|Standard Error of the Mean|2.093||0.007|2-Sided|95.0|-9.79|-1.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638833|NCT01942668|3012055|Superiority||Mean Difference (Final Values)|-5.59|Standard Error of the Mean|2.132||0.009|2-Sided|95.0|-9.77|-1.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638834|NCT01942668|3012055|Superiority||Mean Difference (Final Values)|-5.76|Standard Error of the Mean|2.08||0.006|2-Sided|95.0|-9.85|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638988|NCT01942668|3012102|Superiority|||||||0.613||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact||||
1638835|NCT01942668|3012055|Superiority||Mean Difference (Final Values)|-5.32|Standard Error of the Mean|2.135||0.013|2-Sided|95.0|-9.52|-1.13||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638836|NCT01942668|3012056|Superiority||Mean Difference (Final Values)|-3.16|Standard Error of the Mean|2.042||0.122|2-Sided|95.0|-7.17|0.85||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638837|NCT01942668|3012056|Superiority||Mean Difference (Final Values)|-5.1|Standard Error of the Mean|2.084||0.015|2-Sided|95.0|-9.19|-1.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638838|NCT01942668|3012056|Superiority||Mean Difference (Final Values)|-2.57|Standard Error of the Mean|2.067||0.215|2-Sided|95.0|-6.63|1.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638839|NCT01942668|3012056|Superiority||Mean Difference (Final Values)|-3.99|Standard Error of the Mean|2.109||0.059|2-Sided|95.0|-8.13|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638840|NCT01942668|3012057|Superiority||Mean Difference (Final Values)|-5.75|Standard Error of the Mean|2.637||0.03|2-Sided|95.0|-10.94|-0.57||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638841|NCT01942668|3012057|Superiority||Mean Difference (Final Values)|-4.72|Standard Error of the Mean|2.639||0.074|2-Sided|95.0|-9.9|0.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638842|NCT01942668|3012057|Superiority||Mean Difference (Final Values)|-6.01|Standard Error of the Mean|2.564||0.019|2-Sided|95.0|-11.04|-0.97||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638843|NCT01942668|3012057|Superiority||Mean Difference (Final Values)|-2.19|Standard Error of the Mean|2.682||0.415|2-Sided|95.0|-7.46|3.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638844|NCT01942668|3012058|Superiority||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|2.427||0.711|2-Sided|95.0|-5.67|3.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638845|NCT01942668|3012058|Superiority||Mean Difference (Final Values)|-0.91|Standard Error of the Mean|2.466||0.714|2-Sided|95.0|-5.75|3.94||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638846|NCT01942668|3012058|Superiority||Mean Difference (Final Values)|-2.15|Standard Error of the Mean|2.411||0.373|2-Sided|95.0|-6.88|2.58||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638847|NCT01942668|3012058|Superiority||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|2.474||0.687|2-Sided|95.0|-5.86|3.86||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638848|NCT01942668|3012059|Superiority||Mean Difference (Final Values)|-2.07|Standard Error of the Mean|2.128||0.332|2-Sided|95.0|-6.25|2.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638849|NCT01942668|3012059|Superiority||Mean Difference (Final Values)|0.66|Standard Error of the Mean|2.168||0.761|2-Sided|95.0|-3.6|4.92||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638850|NCT01942668|3012059|Superiority||Mean Difference (Final Values)|-1.42|Standard Error of the Mean|2.154||0.511|2-Sided|95.0|-5.65|2.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638851|NCT01942668|3012059|Superiority||Mean Difference (Final Values)|-2.69|Standard Error of the Mean|2.197||0.221|2-Sided|95.0|-7.0|1.62||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638852|NCT01942668|3012060|Superiority||Mean Difference (Final Values)|7.51|Standard Error of the Mean|3.667||0.041|2-Sided|95.0|0.3|14.71||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638853|NCT01942668|3012060|Superiority||Mean Difference (Final Values)|8.58|Standard Error of the Mean|3.657||0.019|2-Sided|95.0|1.39|15.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638854|NCT01942668|3012060|Superiority||Mean Difference (Final Values)|5.14|Standard Error of the Mean|3.568||0.15|2-Sided|95.0|-1.87|12.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638855|NCT01942668|3012060|Superiority||Mean Difference (Final Values)|0.96|Standard Error of the Mean|3.719||0.796|2-Sided|95.0|-6.34|8.27||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638856|NCT01942668|3012061|Superiority||Mean Difference (Final Values)|8.94|Standard Error of the Mean|3.152||0.005|2-Sided|95.0|2.75|15.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638857|NCT01942668|3012061|Superiority||Mean Difference (Final Values)|5.04|Standard Error of the Mean|3.193||0.115|2-Sided|95.0|-1.23|11.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638858|NCT01942668|3012061|Superiority||Mean Difference (Final Values)|9.58|Standard Error of the Mean|3.133||0.002|2-Sided|95.0|3.43|15.74||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638989|NCT01942668|3012102|Superiority|||||||0.188||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact||||
1638859|NCT01942668|3012061|Superiority||Mean Difference (Final Values)|4.07|Standard Error of the Mean|3.206||0.205|2-Sided|95.0|-2.23|10.37||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638860|NCT01942668|3012062|Superiority||Mean Difference (Final Values)|2.07|Standard Error of the Mean|2.99||0.488|2-Sided|95.0|-3.8|7.95||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638861|NCT01942668|3012062|Superiority||Mean Difference (Final Values)|6.16|Standard Error of the Mean|3.036||0.043|2-Sided|95.0|0.2|12.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638862|NCT01942668|3012062|Superiority||Mean Difference (Final Values)|3.61|Standard Error of the Mean|3.031||0.233|2-Sided|95.0|-2.34|9.57||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638863|NCT01942668|3012062|Superiority||Mean Difference (Final Values)|1.81|Standard Error of the Mean|3.081||0.558|2-Sided|95.0|-4.24|7.86||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638864|NCT01942668|3012063|Superiority||Mean Difference (Final Values)|-2.98|Standard Error of the Mean|2.923||0.308|2-Sided|95.0|-8.72|2.76||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638865|NCT01942668|3012063|Superiority||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|2.949||0.894|2-Sided|95.0|-6.19|5.4||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638866|NCT01942668|3012063|Superiority||Mean Difference (Final Values)|-3.07|Standard Error of the Mean|2.832||0.279|2-Sided|95.0|-8.64|2.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638867|NCT01942668|3012063|Superiority||Mean Difference (Final Values)|-2.61|Standard Error of the Mean|2.968||0.379|2-Sided|95.0|-8.44|3.22||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638868|NCT01942668|3012064|Superiority||Mean Difference (Final Values)|-1.02|Standard Error of the Mean|2.741||0.709|2-Sided|95.0|-6.41|4.36||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638869|NCT01942668|3012064|Superiority||Mean Difference (Final Values)|0.05|Standard Error of the Mean|2.805||0.987|2-Sided|95.0|-5.46|5.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638870|NCT01942668|3012064|Superiority||Mean Difference (Final Values)|-0.87|Standard Error of the Mean|2.722||0.748|2-Sided|95.0|-6.22|4.47||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638871|NCT01942668|3012064|Superiority||Mean Difference (Final Values)|-5.0|Standard Error of the Mean|2.79||0.074|2-Sided|95.0|-10.48|0.48||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638872|NCT01942668|3012065|Superiority||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|2.515||0.869|2-Sided|95.0|-5.35|4.52||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638873|NCT01942668|3012065|Superiority||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|2.578||0.813|2-Sided|95.0|-5.67|4.45||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638874|NCT01942668|3012065|Superiority||Mean Difference (Final Values)|1.15|Standard Error of the Mean|2.54||0.651|2-Sided|95.0|-3.84|6.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638875|NCT01942668|3012065|Superiority||Mean Difference (Final Values)|-1.25|Standard Error of the Mean|2.593||0.631|2-Sided|95.0|-6.34|3.84||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638876|NCT01942668|3012066|Superiority||Mean Difference (Final Values)|-2.41|Standard Error of the Mean|3.376||0.476|2-Sided|95.0|-9.04|4.23||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638877|NCT01942668|3012066|Superiority||Mean Difference (Final Values)|-2.05|Standard Error of the Mean|3.367||0.542|2-Sided|95.0|-8.67|4.56||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638878|NCT01942668|3012066|Superiority||Mean Difference (Final Values)|-3.99|Standard Error of the Mean|3.275||0.223|2-Sided|95.0|-10.43|2.44||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638879|NCT01942668|3012066|Superiority||Mean Difference (Final Values)|1.91|Standard Error of the Mean|3.443||0.579|2-Sided|95.0|-4.85|8.67||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638880|NCT01942668|3012067|Superiority||Mean Difference (Final Values)|-2.59|Standard Error of the Mean|3.133||0.409|2-Sided|95.0|-8.74|3.56||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638881|NCT01942668|3012067|Superiority||Mean Difference (Final Values)|-6.33|Standard Error of the Mean|3.176||0.047|2-Sided|95.0|-12.56|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638882|NCT01942668|3012067|Superiority||Mean Difference (Final Values)|-0.91|Standard Error of the Mean|3.107||0.769|2-Sided|95.0|-7.01|5.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638990|NCT01942668|3012102|Superiority|||||||0.469||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact||||
1638883|NCT01942668|3012067|Superiority||Mean Difference (Final Values)|1.82|Standard Error of the Mean|3.219||0.573|2-Sided|95.0|-4.51|8.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638884|NCT01942668|3012068|Superiority||Mean Difference (Final Values)|0.17|Standard Error of the Mean|2.893||0.952|2-Sided|95.0|-5.51|5.86||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638885|NCT01942668|3012068|Superiority||Mean Difference (Final Values)|-1.39|Standard Error of the Mean|2.947||0.637|2-Sided|95.0|-7.18|4.39||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638886|NCT01942668|3012068|Superiority||Mean Difference (Final Values)|2.86|Standard Error of the Mean|2.922||0.327|2-Sided|95.0|-2.87|8.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638887|NCT01942668|3012068|Superiority||Mean Difference (Final Values)|3.15|Standard Error of the Mean|3.003||0.294|2-Sided|95.0|-2.75|9.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638888|NCT01942668|3012069|Superiority||Mean Difference (Final Values)|-6.85|Standard Error of the Mean|3.127||0.029|2-Sided|95.0|-12.99|-0.7||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638889|NCT01942668|3012069|Superiority||Mean Difference (Final Values)|-9.96|Standard Error of the Mean|3.129||0.002|2-Sided|95.0|-16.11|-3.81||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638890|NCT01942668|3012069|Superiority||Mean Difference (Final Values)|-10.02|Standard Error of the Mean|3.04||0.001|2-Sided|95.0|-15.99|-4.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638891|NCT01942668|3012069|Superiority||Mean Difference (Final Values)|-6.56|Standard Error of the Mean|3.18||0.04|2-Sided|95.0|-12.8|-0.31||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638892|NCT01942668|3012070|Superiority||Mean Difference (Final Values)|-6.18|Standard Error of the Mean|2.8||0.028|2-Sided|95.0|-11.68|-0.68||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638893|NCT01942668|3012070|Superiority||Mean Difference (Final Values)|-8.69|Standard Error of the Mean|2.847||0.002|2-Sided|95.0|-14.28|-3.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638894|NCT01942668|3012070|Superiority||Mean Difference (Final Values)|-6.72|Standard Error of the Mean|2.781||0.016|2-Sided|95.0|-12.18|-1.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638895|NCT01942668|3012070|Superiority||Mean Difference (Final Values)|-7.54|Standard Error of the Mean|2.854||0.008|2-Sided|95.0|-13.14|-1.93||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638896|NCT01942668|3012071|Superiority||Mean Difference (Final Values)|-2.99|Standard Error of the Mean|2.685||0.265|2-Sided|95.0|-8.27|2.28||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638897|NCT01942668|3012071|Superiority||Mean Difference (Final Values)|-5.85|Standard Error of the Mean|2.734||0.033|2-Sided|95.0|-11.22|-0.48||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638898|NCT01942668|3012071|Superiority||Mean Difference (Final Values)|-3.36|Standard Error of the Mean|2.715||0.216|2-Sided|95.0|-8.69|1.97||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638899|NCT01942668|3012071|Superiority||Mean Difference (Final Values)|-6.48|Standard Error of the Mean|2.77||0.02|2-Sided|95.0|-11.92|-1.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638900|NCT01942668|3012072|Superiority||Mean Difference (Final Values)|-6.78|Standard Error of the Mean|2.404||0.005|2-Sided|95.0|-11.5|-2.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638901|NCT01942668|3012072|Superiority||Mean Difference (Final Values)|-7.96|Standard Error of the Mean|2.397|<|0.001|2-Sided|95.0|-12.67|-3.25||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638902|NCT01942668|3012072|Superiority||Mean Difference (Final Values)|-7.48|Standard Error of the Mean|2.322|<|0.001|2-Sided|95.0|-12.04|-2.92||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638903|NCT01942668|3012072|Superiority||Mean Difference (Final Values)|-4.61|Standard Error of the Mean|2.427|<|0.058|2-Sided|95.0|-9.38|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638904|NCT01942668|3012073|Superiority||Mean Difference (Final Values)|-4.99|Standard Error of the Mean|2.096||0.018|2-Sided|95.0|-9.11|-0.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638905|NCT01942668|3012073|Superiority||Mean Difference (Final Values)|-5.58|Standard Error of the Mean|2.122||0.009|2-Sided|95.0|-9.75|-1.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638906|NCT01942668|3012073|Superiority||Mean Difference (Final Values)|-5.25|Standard Error of the Mean|2.093||0.012|2-Sided|95.0|-9.36|-1.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638991|NCT01942668|3012102|Superiority|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact||||
1638907|NCT01942668|3012073|Superiority||Mean Difference (Final Values)|-5.48|Standard Error of the Mean|2.138||0.011|2-Sided|95.0|-9.68|-1.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638908|NCT01942668|3012074|Superiority||Mean Difference (Final Values)|-2.53|Standard Error of the Mean|2.007||0.207|2-Sided|95.0|-6.47|1.41||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638909|NCT01942668|3012074|Superiority||Mean Difference (Final Values)|-4.6|Standard Error of the Mean|2.03||0.024|2-Sided|95.0|-8.58|-0.61||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638910|NCT01942668|3012074|Superiority||Mean Difference (Final Values)|-2.54|Standard Error of the Mean|2.015||0.207|2-Sided|95.0|-6.5|1.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638911|NCT01942668|3012074|Superiority||Mean Difference (Final Values)|-4.39|Standard Error of the Mean|2.059||0.033|2-Sided|95.0|-8.44|-0.35||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638912|NCT01942668|3012075|Superiority||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.166||0.07|2-Sided|95.0|-0.63|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638913|NCT01942668|3012075|Superiority||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.166||0.004|2-Sided|95.0|-0.81|-0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638914|NCT01942668|3012075|Superiority||Mean Difference (Final Values)|-0.73|Standard Error of the Mean|0.162|<|0.001|2-Sided|95.0|-1.05|-0.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638915|NCT01942668|3012075|Superiority||Mean Difference (Final Values)|-0.43|Standard Error of the Mean|0.169|<|0.012|2-Sided|95.0|-0.76|-0.1||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638916|NCT01942668|3012076|Superiority||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.147||0.179|2-Sided|95.0|-0.49|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638917|NCT01942668|3012076|Superiority||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|0.149||0.003|2-Sided|95.0|-0.73|-0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638918|NCT01942668|3012076|Superiority||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.146||0.004|2-Sided|95.0|-0.71|-0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638919|NCT01942668|3012076|Superiority||Mean Difference (Final Values)|-0.55|Standard Error of the Mean|0.15|<|0.001|2-Sided|95.0|-0.84|-0.25||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638920|NCT01942668|3012077|Superiority||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.141||0.023|2-Sided|95.0|-0.6|-0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638921|NCT01942668|3012077|Superiority||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.143|<|0.001|2-Sided|95.0|-0.76|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638922|NCT01942668|3012077|Superiority||Mean Difference (Final Values)|-0.34|Standard Error of the Mean|0.143|<|0.016|2-Sided|95.0|-0.62|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638923|NCT01942668|3012077|Superiority||Mean Difference (Final Values)|-0.58|Standard Error of the Mean|0.145|<|0.001|2-Sided|95.0|-0.87|-0.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638924|NCT01942668|3012078|Superiority||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.252||0.247|2-Sided|95.0|-0.79|0.2||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638925|NCT01942668|3012078|Superiority||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.252||0.093|2-Sided|95.0|-0.92|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638926|NCT01942668|3012078|Superiority||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.244||0.044|2-Sided|95.0|-0.97|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638927|NCT01942668|3012078|Superiority||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.257||0.421|2-Sided|95.0|-0.71|0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638928|NCT01942668|3012079|Superiority||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.216||0.846|2-Sided|95.0|-0.47|0.38||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638929|NCT01942668|3012079|Superiority||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.219||0.181|2-Sided|95.0|-0.72|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638930|NCT01942668|3012079|Superiority||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.214||0.992|2-Sided|95.0|-0.42|0.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638931|NCT01942668|3012079|Superiority||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.221||0.221|2-Sided|95.0|-0.7|0.16||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1639053|NCT01942668|3012118|Superiority|||||||0.049|||||||Fisher Exact||||
1638932|NCT01942668|3012080|Superiority||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.204||0.625|2-Sided|95.0|-0.5|0.3||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638933|NCT01942668|3012080|Superiority||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|0.208||0.081|2-Sided|95.0|-0.77|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638934|NCT01942668|3012080|Superiority||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.206||0.773|2-Sided|95.0|-0.34|0.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638935|NCT01942668|3012080|Superiority||Mean Difference (Final Values)|-0.41|Standard Error of the Mean|0.21||0.049|2-Sided|95.0|-0.83|0.0||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638936|NCT01942668|3012081|Superiority||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.168||0.243|2-Sided|95.0|-0.53|0.13||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638937|NCT01942668|3012081|Superiority||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.169||0.092|2-Sided|95.0|-0.62|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638938|NCT01942668|3012081|Superiority||Mean Difference (Final Values)|-0.43|Standard Error of the Mean|0.164||0.01|2-Sided|95.0|-0.75|-0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638939|NCT01942668|3012081|Superiority||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.171||0.635|2-Sided|95.0|-0.42|0.26||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638940|NCT01942668|3012082|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.149||0.739|2-Sided|95.0|-0.34|0.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638941|NCT01942668|3012082|Superiority||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.152||0.117|2-Sided|95.0|-0.54|0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638942|NCT01942668|3012082|Superiority||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.148||0.308|2-Sided|95.0|-0.44|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638943|NCT01942668|3012082|Superiority||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.152||0.197|2-Sided|95.0|-0.49|0.1||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638944|NCT01942668|3012083|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.138||0.73|2-Sided|95.0|-0.32|0.22||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638945|NCT01942668|3012083|Superiority||Mean Difference (Final Values)|-0.33|Standard Error of the Mean|0.141||0.018|2-Sided|95.0|-0.61|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638946|NCT01942668|3012083|Superiority||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.14||0.378|2-Sided|95.0|-0.4|0.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638947|NCT01942668|3012083|Superiority||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.143||0.474|2-Sided|95.0|-0.38|0.18||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638948|NCT01942668|3012084|Superiority||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.179||0.955|2-Sided|95.0|-0.36|0.34||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638949|NCT01942668|3012084|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.179||0.796|2-Sided|95.0|-0.4|0.31||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638950|NCT01942668|3012084|Superiority||Mean Difference (Final Values)|-0.54|Standard Error of the Mean|0.175||0.002|2-Sided|95.0|-0.88|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638951|NCT01942668|3012084|Superiority||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.183||0.25|2-Sided|95.0|-0.57|0.15||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638952|NCT01942668|3012085|Superiority||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.166||0.616|2-Sided|95.0|-0.41|0.24||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638953|NCT01942668|3012085|Superiority||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.168||0.469|2-Sided|95.0|-0.45|0.21||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638954|NCT01942668|3012085|Superiority||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.165||0.066|2-Sided|95.0|-0.63|0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638955|NCT01942668|3012085|Superiority||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.169||0.04|2-Sided|95.0|-0.68|-0.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638956|NCT01942668|3012086|Superiority||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.156||0.439|2-Sided|95.0|-0.43|0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1639054|NCT01942668|3012118|Superiority|||||||0.048|||||||Fisher Exact||||
1639055|NCT01942668|3012118|Superiority||||||<|0.001|||||||Fisher Exact||||
1638957|NCT01942668|3012086|Superiority||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.159||0.437|2-Sided|95.0|-0.44|0.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638958|NCT01942668|3012086|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.158||0.732|2-Sided|95.0|-0.36|0.26||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638959|NCT01942668|3012086|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.161||0.284|2-Sided|95.0|-0.49|0.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638960|NCT01942668|3012087|Superiority||Mean Difference (Final Values)|-0.72|Standard Error of the Mean|0.272||0.008|2-Sided|95.0|-1.26|-0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638961|NCT01942668|3012087|Superiority||Mean Difference (Final Values)|-1.23|Standard Error of the Mean|0.272|<|0.001|2-Sided|95.0|-1.76|-0.69||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 12|Mixed Models Analysis||||
1638962|NCT01942668|3012087|Superiority||Mean Difference (Final Values)|-1.46|Standard Error of the Mean|0.265|<|0.001|2-Sided|95.0|-1.98|-0.94||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638963|NCT01942668|3012087|Superiority||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.276|<|0.001|2-Sided|95.0|-1.75|-0.66||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 12|Mixed Models Analysis||||
1638964|NCT01942668|3012088|Superiority||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.254||0.007|2-Sided|95.0|-1.19|-0.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638965|NCT01942668|3012088|Superiority||Mean Difference (Final Values)|-1.12|Standard Error of the Mean|0.257|<|0.001|2-Sided|95.0|-1.63|-0.62||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Month 6|Mixed Models Analysis||||
1638966|NCT01942668|3012088|Superiority||Mean Difference (Final Values)|-1.32|Standard Error of the Mean|0.253|<|0.001|2-Sided|95.0|-1.81|-0.82||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638967|NCT01942668|3012088|Superiority||Mean Difference (Final Values)|-1.4|Standard Error of the Mean|0.258|<|0.001|2-Sided|95.0|-1.91|-0.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Month 6|Mixed Models Analysis||||
1638968|NCT01942668|3012089|Superiority||Mean Difference (Final Values)|-1.04|Standard Error of the Mean|0.238|<|0.001|2-Sided|95.0|-1.51|-0.58||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638969|NCT01942668|3012089|Superiority||Mean Difference (Final Values)|-1.17|Standard Error of the Mean|0.242|<|0.001|2-Sided|95.0|-1.64|-0.69||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||||
1638970|NCT01942668|3012089|Superiority||Mean Difference (Final Values)|-1.31|Standard Error of the Mean|0.242|<|0.001|2-Sided|95.0|-1.79|-0.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638971|NCT01942668|3012089|Superiority||Mean Difference (Final Values)|-1.65|Standard Error of the Mean|0.246|<|0.001|2-Sided|95.0|-2.13|-1.17||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||||
1638972|NCT01942668|3012094|Superiority|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact||||
1638973|NCT01942668|3012094|Superiority|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 4|Fisher Exact||||
1638974|NCT01942668|3012094|Superiority|||||||0.265||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact||||
1638975|NCT01942668|3012094|Superiority|||||||0.023||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 4|Fisher Exact||||
1638976|NCT01942668|3012095|Superiority|||||||0.685||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact||||
1638977|NCT01942668|3012095|Superiority|||||||0.138||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact||||
1638978|NCT01942668|3012095|Superiority|||||||0.036||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact||||
1638979|NCT01942668|3012095|Superiority|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact||||
1638980|NCT01942668|3012096|Superiority|||||||0.681||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact||||
1638981|NCT01942668|3012096|Superiority|||||||0.184||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact||||
1638982|NCT01942668|3012096|Superiority|||||||0.085||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact||||
1638983|NCT01942668|3012096|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact||||
1638984|NCT01942668|3012097|Superiority|||||||0.257||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact||||
1638985|NCT01942668|3012097|Superiority|||||||0.26||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact||||
1638992|NCT01942668|3012103|Superiority|||||||0.182||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact||||
1638993|NCT01942668|3012103|Superiority|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 3|Fisher Exact||||
1638994|NCT01942668|3012103|Superiority|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact||||
1638995|NCT01942668|3012103|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 3|Fisher Exact||||
1638996|NCT01942668|3012104|Superiority|||||||0.256||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact||||
1638997|NCT01942668|3012104|Superiority|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 2|Fisher Exact||||
1638998|NCT01942668|3012104|Superiority|||||||0.022||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact||||
1638999|NCT01942668|3012104|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 2|Fisher Exact||||
1639000|NCT01942668|3012105|Superiority|||||||0.032||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact||||
1639001|NCT01942668|3012105|Superiority|||||||0.012||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo during Trimester 1|Fisher Exact||||
1639002|NCT01942668|3012105|Superiority|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact||||
1639003|NCT01942668|3012105|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo during Trimester 1|Fisher Exact||||
1639004|NCT01942668|3012106|Superiority|||||||0.738|||||||Fisher Exact||||
1639005|NCT01942668|3012106|Superiority|||||||0.183|||||||Fisher Exact||||
1639006|NCT01942668|3012106|Superiority|||||||0.535|||||||Fisher Exact||||
1639007|NCT01942668|3012106|Superiority|||||||0.023|||||||Fisher Exact||||
1639008|NCT01942668|3012107|Superiority|||||||1|||||||Fisher Exact||||
1639009|NCT01942668|3012107|Superiority|||||||0.352|||||||Fisher Exact||||
1639010|NCT01942668|3012107|Superiority|||||||0.616|||||||Fisher Exact||||
1639011|NCT01942668|3012107|Superiority|||||||0.013|||||||Fisher Exact||||
1639012|NCT01942668|3012108|Superiority|||||||1|||||||Fisher Exact||||
1639013|NCT01942668|3012108|Superiority|||||||0.501|||||||Fisher Exact||||
1639014|NCT01942668|3012108|Superiority|||||||0.643|||||||Fisher Exact||||
1639015|NCT01942668|3012108|Superiority|||||||0.008|||||||Fisher Exact||||
1639016|NCT01942668|3012109|Superiority|||||||0.639|||||||Fisher Exact||||
1639017|NCT01942668|3012109|Superiority|||||||0.215|||||||Fisher Exact||||
1639018|NCT01942668|3012109|Superiority|||||||0.387|||||||Fisher Exact||||
1639019|NCT01942668|3012109|Superiority||||||<|0.001|||||||Fisher Exact||||
1639020|NCT01942668|3012110|Superiority|||||||0.821|||||||Fisher Exact||||
1639021|NCT01942668|3012110|Superiority|||||||0.181|||||||Fisher Exact||||
1639022|NCT01942668|3012110|Superiority|||||||0.315|||||||Fisher Exact||||
1639023|NCT01942668|3012110|Superiority||||||<|0.001|||||||Fisher Exact||||
1639024|NCT01942668|3012111|Superiority|||||||0.522|||||||Fisher Exact||||
1639025|NCT01942668|3012111|Superiority|||||||0.097|||||||Fisher Exact||||
1639026|NCT01942668|3012111|Superiority|||||||0.178|||||||Fisher Exact||||
1639027|NCT01942668|3012111|Superiority||||||<|0.001|||||||Fisher Exact||||
1639028|NCT01942668|3012112|Superiority|||||||0.693|||||||Fisher Exact||||
1639029|NCT01942668|3012112|Superiority|||||||0.091|||||||Fisher Exact||||
1639030|NCT01942668|3012112|Superiority|||||||0.163|||||||Fisher Exact||||
1639031|NCT01942668|3012112|Superiority||||||<|0.001|||||||Fisher Exact||||
1639032|NCT01942668|3012113|Superiority|||||||1|||||||Fisher Exact||||
1639033|NCT01942668|3012113|Superiority|||||||0.145|||||||Fisher Exact||||
1639034|NCT01942668|3012113|Superiority|||||||0.245|||||||Fisher Exact||||
1639035|NCT01942668|3012113|Superiority||||||<|0.001|||||||Fisher Exact||||
1639036|NCT01942668|3012114|Superiority|||||||0.853|||||||Fisher Exact||||
1639037|NCT01942668|3012114|Superiority|||||||0.045|||||||Fisher Exact||||
1639038|NCT01942668|3012114|Superiority|||||||0.11|||||||Fisher Exact||||
1639039|NCT01942668|3012114|Superiority||||||<|0.001|||||||Fisher Exact||||
1639040|NCT01942668|3012115|Superiority|||||||0.481|||||||Fisher Exact||||
1639041|NCT01942668|3012115|Superiority|||||||0.011|||||||Fisher Exact||||
1639042|NCT01942668|3012115|Superiority|||||||0.044|||||||Fisher Exact||||
1639043|NCT01942668|3012115|Superiority||||||<|0.001|||||||Fisher Exact||||
1639044|NCT01942668|3012116|Superiority|||||||0.426|||||||Fisher Exact||||
1639045|NCT01942668|3012116|Superiority|||||||0.023|||||||Fisher Exact||||
1639046|NCT01942668|3012116|Superiority|||||||0.059|||||||Fisher Exact||||
1639047|NCT01942668|3012116|Superiority||||||<|0.001|||||||Fisher Exact||||
1639048|NCT01942668|3012117|Superiority|||||||0.649|||||||Fisher Exact||||
1639049|NCT01942668|3012117|Superiority|||||||0.03|||||||Fisher Exact||||
1639050|NCT01942668|3012117|Superiority|||||||0.123|||||||Fisher Exact||||
1639051|NCT01942668|3012117|Superiority||||||<|0.001|||||||Fisher Exact||||
1639052|NCT01942668|3012118|Superiority|||||||0.328|||||||Fisher Exact||||
1639070|NCT01942668|3012122|Superiority|||||||0.183|||||||Fisher Exact||||
1639071|NCT01942668|3012122|Superiority|||||||0.009|||||||Fisher Exact||||
1639072|NCT01942668|3012123|Superiority|||||||0.737|||||||Fisher Exact||||
1639073|NCT01942668|3012123|Superiority|||||||0.386|||||||Fisher Exact||||
1639074|NCT01942668|3012123|Superiority|||||||0.125|||||||Fisher Exact||||
1639075|NCT01942668|3012123|Superiority|||||||0.006|||||||Fisher Exact||||
1639076|NCT01942668|3012124|Superiority|||||||0.738|||||||Fisher Exact||||
1639077|NCT01942668|3012124|Superiority|||||||0.183|||||||Fisher Exact||||
1639078|NCT01942668|3012124|Superiority|||||||0.084|||||||Fisher Exact||||
1639079|NCT01942668|3012124|Superiority|||||||0.002|||||||Fisher Exact||||
1639080|NCT01942668|3012125|Superiority|||||||0.769|||||||Fisher Exact||||
1639081|NCT01942668|3012125|Superiority|||||||0.225|||||||Fisher Exact||||
1639082|NCT01942668|3012125|Superiority|||||||0.075|||||||Fisher Exact||||
1639083|NCT01942668|3012125|Superiority|||||||0.002|||||||Fisher Exact||||
1639084|NCT01942668|3012126|Superiority|||||||1|||||||Fisher Exact||||
1639085|NCT01942668|3012126|Superiority|||||||0.352|||||||Fisher Exact||||
1639086|NCT01942668|3012126|Superiority|||||||0.095|||||||Fisher Exact||||
1639087|NCT01942668|3012126|Superiority|||||||0.001|||||||Fisher Exact||||
1639088|NCT01942668|3012127|Superiority|||||||0.792|||||||Fisher Exact||||
1639089|NCT01942668|3012127|Superiority|||||||0.26|||||||Fisher Exact||||
1639090|NCT01942668|3012127|Superiority|||||||0.067|||||||Fisher Exact||||
1639091|NCT01942668|3012127|Superiority|||||||0|||||||Fisher Exact||||
1639092|NCT01942668|3012128|Superiority|||||||0.792|||||||Fisher Exact||||
1639093|NCT01942668|3012128|Superiority|||||||0.137|||||||Fisher Exact||||
1639094|NCT01942668|3012128|Superiority|||||||0.032|||||||Fisher Exact||||
1639095|NCT01942668|3012128|Superiority|||||||0|||||||Fisher Exact||||
1639096|NCT01942668|3012129|Superiority|||||||0.495|||||||Fisher Exact||||
1639097|NCT01942668|3012129|Superiority|||||||0.082|||||||Fisher Exact||||
1639098|NCT01942668|3012129|Superiority|||||||0.04|||||||Fisher Exact||||
1639099|NCT01942668|3012129|Superiority|||||||0|||||||Fisher Exact||||
1639100|NCT01942668|3012130|Superiority|||||||0.661|||||||Fisher Exact||||
1639101|NCT01942668|3012130|Superiority|||||||0.131|||||||Fisher Exact||||
1639102|NCT01942668|3012130|Superiority|||||||0.069|||||||Fisher Exact||||
1639103|NCT01942668|3012130|Superiority|||||||0|||||||Fisher Exact||||
1639104|NCT01942668|3012131|Superiority|||||||0.692|||||||Fisher Exact||||
1639105|NCT01942668|3012131|Superiority|||||||0.28|||||||Fisher Exact||||
1639106|NCT01942668|3012131|Superiority|||||||0.122|||||||Fisher Exact||||
1639107|NCT01942668|3012131|Superiority|||||||0|||||||Fisher Exact||||
1639108|NCT01942668|3012133|Superiority|||||||0.002||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact||||
1639109|NCT01942668|3012133|Superiority||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact||||
1639110|NCT01942668|3012133|Superiority||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact||||
1639111|NCT01942668|3012133|Superiority||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact||||
1639112|NCT01942668|3012135|Superiority|||||||0.002||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact||||
1639113|NCT01942668|3012135|Superiority|||||||0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact||||
1639114|NCT01942668|3012135|Superiority||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact||||
1639115|NCT01942668|3012135|Superiority||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact||||
1639116|NCT01942668|3012137|Superiority|||||||0.004||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact||||
1639117|NCT01942668|3012137|Superiority|||||||0.007||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact||||
1639118|NCT01942668|3012137|Superiority|||||||0.005||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact||||
1639119|NCT01942668|3012137|Superiority||||||<|0.001||||||P-value is derived from comparing % Very Much Improved+Much Improved between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact||||
1639120|NCT01942668|3012138|Superiority|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||>=75% Reduction|
1639121|NCT01942668|3012138|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||>=50% Reduction|
1639122|NCT01942668|3012138|Superiority||||||<|0.056||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||>=75% Reduction|
1639123|NCT01942668|3012138|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||>=50% Reduction|
1639124|NCT01942668|3012138|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||>=75% Reduction|
1639125|NCT01942668|3012138|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||>=50% Reduction|
1639126|NCT01942668|3012138|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||>=75% Reduction|
1639127|NCT01942668|3012138|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||>=50% Reduction|
1639128|NCT01942668|3012139|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||>=75% Reduction|
1639129|NCT01942668|3012139|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||>=50% Reduction|
1639130|NCT01942668|3012139|Superiority||||||<|0.003||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||>=75% Reduction|
1639131|NCT01942668|3012139|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||>=50% Reduction|
1639132|NCT01942668|3012139|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||>=75% Reduction|
1639133|NCT01942668|3012139|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||>=50% Reduction|
1639134|NCT01942668|3012139|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||>=75% Reduction|
1639135|NCT01942668|3012139|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||>=50% Reduction|
1639136|NCT01942668|3012140|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||>=75% Reduction|
1639137|NCT01942668|3012140|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||>=50% Reduction|
1639138|NCT01942668|3012140|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||>=75% Reduction|
1639139|NCT01942668|3012140|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||>=50% Reduction|
1639140|NCT01942668|3012140|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||>=75% Reduction|
1639141|NCT01942668|3012140|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||>=50% Reduction|
1639142|NCT01942668|3012140|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||>=75% Reduction|
1639143|NCT01942668|3012140|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||>=50% Reduction|
1639144|NCT01942668|3012141|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||>=75% Reduction|
1639145|NCT01942668|3012141|Superiority||||||<|0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||>=50% Reduction|
1639146|NCT01942668|3012141|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||>=75% Reduction|
1639147|NCT01942668|3012141|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||>=50% Reduction|
1639148|NCT01942668|3012141|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||>=75% Reduction|
1639149|NCT01942668|3012141|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||>=50% Reduction|
1639150|NCT01942668|3012141|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||>=75% Reduction|
1639151|NCT01942668|3012141|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||>=50% Reduction|
1639152|NCT01942668|3012142|Superiority|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||>=75% Reduction|
1639153|NCT01942668|3012142|Superiority|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||>=50% Reduction|
1639154|NCT01942668|3012142|Superiority|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||>=75% Reduction|
1639155|NCT01942668|3012142|Superiority|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||>=50% Reduction|
1639156|NCT01942668|3012142|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||>=75% Reduction|
1639157|NCT01942668|3012142|Superiority||||||<|0.013||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||>=50% Reduction|
1639909|NCT01934010|3013168|Superiority|||||||0.0022|||||||Fisher Exact||||
1639158|NCT01942668|3012142|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||>=75% Reduction|
1639159|NCT01942668|3012142|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||>=50% Reduction|
1639160|NCT01942668|3012143|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||>=75% Reduction|
1639161|NCT01942668|3012143|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||>=50% Reduction|
1639162|NCT01942668|3012143|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||>=75% Reduction|
1639163|NCT01942668|3012143|Superiority||||||<|0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||>=50% Reduction|
1639164|NCT01942668|3012143|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||>=75% Reduction|
1639165|NCT01942668|3012143|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||>=50% Reduction|
1639166|NCT01942668|3012143|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||>=75% Reduction|
1639167|NCT01942668|3012143|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||>=50% Reduction|
1639168|NCT01942668|3012144|Superiority|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||>=75% Reduction|
1639169|NCT01942668|3012144|Superiority|||||||0.02||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||>=50% Reduction|
1639170|NCT01942668|3012144|Superiority|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||>=75% Reduction|
1639171|NCT01942668|3012144|Superiority|||||||0.048||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||>=50% Reduction|
1639172|NCT01942668|3012144|Superiority|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||>=75% Reduction|
1639173|NCT01942668|3012144|Superiority|||||||0.05||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||>=50% Reduction|
1639174|NCT01942668|3012144|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||>=75% Reduction|
1639175|NCT01942668|3012144|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||>=50% Reduction|
1639176|NCT01942668|3012145|Superiority|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||>=75% Reduction|
1639177|NCT01942668|3012145|Superiority|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||>=50% Reduction|
1639178|NCT01942668|3012145|Superiority|||||||0.058||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||>=75% Reduction|
1639179|NCT01942668|3012145|Superiority|||||||0.063||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||>=50% Reduction|
1639180|NCT01942668|3012145|Superiority|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||>=75% Reduction|
1639181|NCT01942668|3012145|Superiority|||||||0.048||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||>=50% Reduction|
1639182|NCT01942668|3012145|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||>=75% Reduction|
1639183|NCT01942668|3012145|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||>=50% Reduction|
1639184|NCT01942668|3012146|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||>=75% Reduction|
1639185|NCT01942668|3012146|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||>=50% Reduction|
1639186|NCT01942668|3012146|Superiority||||||<|0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||>=75% Reduction|
1639187|NCT01942668|3012146|Superiority||||||<|0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||>=50% Reduction|
1639188|NCT01942668|3012146|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||>=75% Reduction|
1639189|NCT01942668|3012146|Superiority||||||<|0.011||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||>=50% Reduction|
1639190|NCT01942668|3012146|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||>=75% Reduction|
1639191|NCT01942668|3012146|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||>=50% Reduction|
1639910|NCT01934010|3013168|Superiority|||||||0.2401|||||||Fisher Exact||||
1639192|NCT01942668|3012147|Superiority|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||>=75% Reduction|
1639193|NCT01942668|3012147|Superiority|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||>=50% Reduction|
1639194|NCT01942668|3012147|Superiority|||||||0.074||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||>=75% Reduction|
1639195|NCT01942668|3012147|Superiority|||||||0.089||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||>=50% Reduction|
1639196|NCT01942668|3012147|Superiority|||||||0.11||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||>=75% Reduction|
1639197|NCT01942668|3012147|Superiority|||||||0.115||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||>=50% Reduction|
1639198|NCT01942668|3012147|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||>=75% Reduction|
1639199|NCT01942668|3012147|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||>=50% Reduction|
1639200|NCT01942668|3012148|Superiority|||||||0.011||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||>=75% Reduction|
1639201|NCT01942668|3012148|Superiority|||||||0.058||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||>=50% Reduction|
1639202|NCT01942668|3012148|Superiority|||||||0.261||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||>=75% Reduction|
1639203|NCT01942668|3012148|Superiority|||||||0.352||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||>=50% Reduction|
1639204|NCT01942668|3012148|Superiority|||||||0.546||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||>=75% Reduction|
1639205|NCT01942668|3012148|Superiority|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||>=50% Reduction|
1639206|NCT01942668|3012148|Superiority|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||>=75% Reduction|
1639207|NCT01942668|3012148|Superiority|||||||0.036||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||>=50% Reduction|
1639208|NCT01942668|3012149|Superiority|||||||0.377||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||>=75% Reduction|
1639209|NCT01942668|3012149|Superiority|||||||0.239||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||>=50% Reduction|
1639210|NCT01942668|3012149|Superiority|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||>=75% Reduction|
1639211|NCT01942668|3012149|Superiority|||||||0.828||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||>=50% Reduction|
1639212|NCT01942668|3012149|Superiority|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||>=75% Reduction|
1639213|NCT01942668|3012149|Superiority|||||||0.821||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||>=50% Reduction|
1639214|NCT01942668|3012149|Superiority|||||||1||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||>=75% Reduction|
1639215|NCT01942668|3012149|Superiority|||||||0.523||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||>=50% Reduction|
1639216|NCT01942668|3012150|Superiority|||||||0.005||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||>=75% Reduction|
1639217|NCT01942668|3012150|Superiority|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||>=50% Reduction|
1639218|NCT01942668|3012150|Superiority|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||>=75% Reduction|
1639219|NCT01942668|3012150|Superiority|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Fisher Exact|||>=50% Reduction|
1639220|NCT01942668|3012150|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||>=75% Reduction|
1639221|NCT01942668|3012150|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||>=50% Reduction|
1639222|NCT01942668|3012150|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||>=75% Reduction|
1639223|NCT01942668|3012150|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Fisher Exact|||>=50% Reduction|
1639224|NCT01942668|3012151|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||>=75% Reduction|
1639225|NCT01942668|3012151|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||>=50% Reduction|
1639911|NCT01934010|3013170|Superiority|||||||0.4403|||||||Fisher Exact||||
1639226|NCT01942668|3012151|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||>=75% Reduction|
1639227|NCT01942668|3012151|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Fisher Exact|||>=50% Reduction|
1639228|NCT01942668|3012151|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||>=75% Reduction|
1639229|NCT01942668|3012151|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||>=50% Reduction|
1639230|NCT01942668|3012151|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||>=75% Reduction|
1639231|NCT01942668|3012151|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Fisher Exact|||>=50% Reduction|
1639232|NCT01942668|3012152|Superiority|||||||0.021||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||>=75% Reduction|
1639233|NCT01942668|3012152|Superiority|||||||0.018||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||>=50% Reduction|
1639234|NCT01942668|3012152|Superiority|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||>=75% Reduction|
1639235|NCT01942668|3012152|Superiority|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Fisher Exact|||>=50% Reduction|
1639236|NCT01942668|3012152|Superiority|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||>=75% Reduction|
1639237|NCT01942668|3012152|Superiority|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||>=50% Reduction|
1639238|NCT01942668|3012152|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||>=75% Reduction|
1639239|NCT01942668|3012152|Superiority||||||<|0.004||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Fisher Exact|||>=50% Reduction|
1639240|NCT01942668|3012153|Superiority|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||>=75% Reduction|
1639241|NCT01942668|3012153|Superiority|||||||0.002||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||>=50% Reduction|
1639242|NCT01942668|3012153|Superiority|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||>=75% Reduction|
1639243|NCT01942668|3012153|Superiority|||||||0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Fisher Exact|||>=50% Reduction|
1639244|NCT01942668|3012153|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||>=75% Reduction|
1639245|NCT01942668|3012153|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||>=50% Reduction|
1639246|NCT01942668|3012153|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||>=75% Reduction|
1639247|NCT01942668|3012153|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Fisher Exact|||>=50% Reduction|
1639248|NCT01942668|3012154|Superiority|||||||0.074||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||>=75% Reduction|
1639249|NCT01942668|3012154|Superiority|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||>=50% Reduction|
1639250|NCT01942668|3012154|Superiority|||||||0.053||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||>=75% Reduction|
1639251|NCT01942668|3012154|Superiority|||||||0.012||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Fisher Exact|||>=50% Reduction|
1639252|NCT01942668|3012154|Superiority|||||||0.016||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||>=75% Reduction|
1639253|NCT01942668|3012154|Superiority|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||>=50% Reduction|
1639254|NCT01942668|3012154|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||>=75% Reduction|
1639255|NCT01942668|3012154|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Fisher Exact|||>=50% Reduction|
1639256|NCT01942668|3012155|Superiority|||||||0.037||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||>=75% Reduction|
1639257|NCT01942668|3012155|Superiority|||||||0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||>=50% Reduction|
1639258|NCT01942668|3012155|Superiority|||||||0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||>=75% Reduction|
1639259|NCT01942668|3012155|Superiority|||||||0.017||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Fisher Exact|||>=50% Reduction|
1641777|NCT01890746|3017565|Superiority|||||||0.6942|||||||Wilcoxon rank-sum test||||
1639260|NCT01942668|3012155|Superiority|||||||0.003||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||>=75% Reduction|
1639261|NCT01942668|3012155|Superiority|||||||0.006||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||>=50% Reduction|
1639262|NCT01942668|3012155|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||>=75% Reduction|
1639263|NCT01942668|3012155|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Fisher Exact|||>=50% Reduction|
1639264|NCT01942668|3012156|Superiority|||||||0.018||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||>=75% Reduction|
1639265|NCT01942668|3012156|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||>=50% Reduction|
1639266|NCT01942668|3012156|Superiority||||||<|0.104||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||>=75% Reduction|
1639267|NCT01942668|3012156|Superiority||||||<|0.026||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Fisher Exact|||>=50% Reduction|
1639268|NCT01942668|3012156|Superiority||||||<|0.061||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||>=75% Reduction|
1639269|NCT01942668|3012156|Superiority||||||<|0.019||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||>=50% Reduction|
1639270|NCT01942668|3012156|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||>=75% Reduction|
1639271|NCT01942668|3012156|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Fisher Exact|||>=50% Reduction|
1639272|NCT01942668|3012157|Superiority|||||||0.008||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||>=75% Reduction|
1639273|NCT01942668|3012157|Superiority|||||||0.007||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||>=50% Reduction|
1639274|NCT01942668|3012157|Superiority|||||||0.319||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||>=75% Reduction|
1639275|NCT01942668|3012157|Superiority|||||||0.174||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Fisher Exact|||>=50% Reduction|
1639276|NCT01942668|3012157|Superiority|||||||0.055||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||>=75% Reduction|
1639277|NCT01942668|3012157|Superiority|||||||0.066||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||>=50% Reduction|
1639278|NCT01942668|3012157|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||>=75% Reduction|
1639279|NCT01942668|3012157|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Fisher Exact|||>=50% Reduction|
1639280|NCT01942668|3012158|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||>=75% Reduction|
1639281|NCT01942668|3012158|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||>=50% Reduction|
1639282|NCT01942668|3012158|Superiority||||||<|0.025||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact|||>=75% Reduction|
1639283|NCT01942668|3012158|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Fisher Exact||||
1639284|NCT01942668|3012158|Superiority||||||<|0.017||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||>=75% Reduction|
1639285|NCT01942668|3012158|Superiority||||||<|0.009||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||>=50% Reduction|
1639286|NCT01942668|3012158|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||>=75% Reduction|
1639287|NCT01942668|3012158|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Fisher Exact|||>=50% Reduction|
1639288|NCT01942668|3012159|Superiority|||||||0.1||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||>=75% Reduction|
1639289|NCT01942668|3012159|Superiority|||||||0.015||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||>=50% Reduction|
1639290|NCT01942668|3012159|Superiority|||||||0.478||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||>=75% Reduction|
1639291|NCT01942668|3012159|Superiority|||||||0.377||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Fisher Exact|||>=50% Reduction|
1639292|NCT01942668|3012159|Superiority|||||||0.231||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||>=75% Reduction|
1639293|NCT01942668|3012159|Superiority|||||||0.135||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||>=50% Reduction|
1641988|NCT01884545|3018049|Superiority|||||||0.2313|||||||Regression, Linear||||
1639294|NCT01942668|3012159|Superiority||||||<|0.001||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||>=75% Reduction|
1639295|NCT01942668|3012159|Superiority||||||<|0.003||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Fisher Exact|||>=50% Reduction|
1639296|NCT01942668|3012160|Superiority|||||||0.013||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||>=75% Reduction|
1639297|NCT01942668|3012160|Superiority|||||||0.301||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||>=50% Reduction|
1639298|NCT01942668|3012160|Superiority|||||||0.073||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||>=75% Reduction|
1639299|NCT01942668|3012160|Superiority|||||||0.677||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Fisher Exact|||>=50% Reduction|
1639300|NCT01942668|3012160|Superiority|||||||0.232||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||>=75% Reduction|
1639301|NCT01942668|3012160|Superiority|||||||0.68||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||>=50% Reduction|
1639302|NCT01942668|3012160|Superiority|||||||0.004||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||>=75% Reduction|
1639303|NCT01942668|3012160|Superiority|||||||0.283||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Fisher Exact|||>=50% Reduction|
1639304|NCT01942668|3012161|Superiority|||||||0.221||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||>=75% Reduction|
1639305|NCT01942668|3012161|Superiority|||||||0.316||||||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||>=50% Reduction|
1639306|NCT01942668|3012161|Superiority|||||||0.372||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||>=75% Reduction|
1639307|NCT01942668|3012161|Superiority|||||||0.706||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Fisher Exact|||>=50% Reduction|
1639308|NCT01942668|3012161|Superiority|||||||0.374||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||>=75% Reduction|
1639309|NCT01942668|3012161|Superiority|||||||1||||||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||>=50% Reduction|
1639310|NCT01942668|3012161|Superiority|||||||0.622||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||>=75% Reduction|
1639311|NCT01942668|3012161|Superiority|||||||0.85||||||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Fisher Exact|||>=50% Reduction|
1639312|NCT01942668|3012162|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.099||0.088|2-Sided|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639313|NCT01942668|3012162|Superiority||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.1||0.039|2-Sided|95.0|-0.4|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639314|NCT01942668|3012162|Superiority||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.57|-0.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639315|NCT01942668|3012162|Superiority||Mean Difference (Final Values)|-0.57|Standard Error of the Mean|0.101|<|0.001|2-Sided|95.0|-0.77|-0.37||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639316|NCT01942668|3012163|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.096||0.071|2-Sided|95.0|-0.36|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639317|NCT01942668|3012163|Superiority||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.098||0.027|2-Sided|95.0|-0.41|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639318|NCT01942668|3012163|Superiority||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.097|<|0.001|2-Sided|95.0|-0.54|-0.16||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639319|NCT01942668|3012163|Superiority||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.099|<|0.001|2-Sided|95.0|-0.72|-0.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639320|NCT01942668|3012164|Superiority||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.094||0.283|2-Sided|95.0|-0.29|0.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639321|NCT01942668|3012164|Superiority||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.095||0.038|2-Sided|95.0|-0.39|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639322|NCT01942668|3012164|Superiority||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.095||0.007|2-Sided|95.0|-0.44|-0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639323|NCT01942668|3012164|Superiority||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.096|<|0.001|2-Sided|95.0|-0.71|-0.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639324|NCT01942668|3012165|Superiority||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.09||0.006|2-Sided|95.0|-0.43|-0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639325|NCT01942668|3012165|Superiority||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.091||0.022|2-Sided|95.0|-0.39|-0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639326|NCT01942668|3012165|Superiority||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.091||0.003|2-Sided|95.0|-0.45|-0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639327|NCT01942668|3012165|Superiority||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.092|<|0.001|2-Sided|95.0|-0.66|-0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639328|NCT01942668|3012166|Superiority||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.085||0.081|2-Sided|95.0|-0.31|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639329|NCT01942668|3012166|Superiority||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.086||0.169|2-Sided|95.0|-0.29|0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639330|NCT01942668|3012166|Superiority||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.085||0.016|2-Sided|95.0|-0.37|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639331|NCT01942668|3012166|Superiority||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.087|<|0.001|2-Sided|95.0|-0.55|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639332|NCT01942668|3012167|Superiority||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.083||0.014|2-Sided|95.0|-0.37|-0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639333|NCT01942668|3012167|Superiority||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.084||0.072|2-Sided|95.0|-0.32|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639334|NCT01942668|3012167|Superiority||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.083||0.006|2-Sided|95.0|-0.4|-0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639335|NCT01942668|3012167|Superiority||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.085|<|0.001|2-Sided|95.0|-0.54|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639336|NCT01942668|3012168|Superiority||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.082||0.018|2-Sided|95.0|-0.35|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639337|NCT01942668|3012168|Superiority||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.083||0.413|2-Sided|95.0|-0.23|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639338|NCT01942668|3012168|Superiority||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.082||0.053|2-Sided|95.0|-0.32|0.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639339|NCT01942668|3012168|Superiority||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|0.084|<|0.001|2-Sided|95.0|-0.53|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639340|NCT01942668|3012169|Superiority||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.067||0.067|2-Sided|95.0|-0.26|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639341|NCT01942668|3012169|Superiority||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.068||0.886|2-Sided|95.0|-0.12|0.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639342|NCT01942668|3012169|Superiority||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.068||0.062|2-Sided|95.0|-0.26|0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639343|NCT01942668|3012169|Superiority||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.069|<|0.001|2-Sided|95.0|-0.36|-0.09||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639344|NCT01942668|3012170|Superiority||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.057||0.072|2-Sided|95.0|-0.21|0.01||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639345|NCT01942668|3012170|Superiority||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.057||0.71|2-Sided|95.0|-0.13|0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639552|NCT01942590|3012223|Other|||||||0.142||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided||||
1639346|NCT01942668|3012170|Superiority||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.057||0.011|2-Sided|95.0|-0.26|-0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639347|NCT01942668|3012170|Superiority||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.058||0.027|2-Sided|95.0|-0.24|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639348|NCT01942668|3012171|Superiority||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.048||0.232|2-Sided|95.0|-0.15|0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639349|NCT01942668|3012171|Superiority||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.048||0.506|2-Sided|95.0|-0.06|0.13||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639350|NCT01942668|3012171|Superiority||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.048||0.06|2-Sided|95.0|-0.19|0.0||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639351|NCT01942668|3012171|Superiority||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.049||0.03|2-Sided|95.0|-0.2|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639352|NCT01942668|3012172|Superiority||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.037||0.72|2-Sided|95.0|-0.09|0.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639353|NCT01942668|3012172|Superiority||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.037||0.239|2-Sided|95.0|-0.03|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639354|NCT01942668|3012172|Superiority||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.037||0.319|2-Sided|95.0|-0.11|0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639355|NCT01942668|3012172|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.038||0.193|2-Sided|95.0|-0.12|0.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639356|NCT01942668|3012173|Superiority||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.027||0.752|2-Sided|95.0|-0.06|0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639357|NCT01942668|3012173|Superiority||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.027||0.106|2-Sided|95.0|-0.01|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639358|NCT01942668|3012173|Superiority||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.027||0.436|2-Sided|95.0|-0.03|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639359|NCT01942668|3012173|Superiority||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.027||0.676|2-Sided|95.0|-0.04|0.07||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639360|NCT01942668|3012174|Superiority||Mean Difference (Final Values)|-13.97|Standard Error of the Mean|3.84|<|0.001|2-Sided|95.0|-21.51|-6.43||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639361|NCT01942668|3012174|Superiority||Mean Difference (Final Values)|-12.62|Standard Error of the Mean|3.89|<|0.001|2-Sided|95.0|-20.26|-4.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639362|NCT01942668|3012174|Superiority||Mean Difference (Final Values)|-18.24|Standard Error of the Mean|3.87|<|0.001|2-Sided|95.0|-25.84|-10.65||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639363|NCT01942668|3012174|Superiority||Mean Difference (Final Values)|-20.61|Standard Error of the Mean|3.93|<|0.001|2-Sided|95.0|-28.32|-12.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639364|NCT01942668|3012175|Superiority||Mean Difference (Final Values)|-15.66|Standard Error of the Mean|3.85|<|0.001|2-Sided|95.0|-23.23|-8.1||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639365|NCT01942668|3012175|Superiority||Mean Difference (Final Values)|-13.98|Standard Error of the Mean|3.9|<|0.001|2-Sided|95.0|-21.65|-6.32||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639366|NCT01942668|3012175|Superiority||Mean Difference (Final Values)|-19.4|Standard Error of the Mean|3.88|<|0.001|2-Sided|95.0|-27.02|-11.77||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639367|NCT01942668|3012175|Superiority||Mean Difference (Final Values)|-21.83|Standard Error of the Mean|3.94|<|0.001|2-Sided|95.0|-29.57|-14.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639368|NCT01942668|3012176|Superiority||Mean Difference (Final Values)|-14.65|Standard Error of the Mean|3.84|<|0.001|2-Sided|95.0|-22.19|-7.12||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639369|NCT01942668|3012176|Superiority||Mean Difference (Final Values)|-13.03|Standard Error of the Mean|3.89|<|0.001|2-Sided|95.0|-20.66|-5.39||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639370|NCT01942668|3012176|Superiority||Mean Difference (Final Values)|-18.37|Standard Error of the Mean|3.87|<|0.001|2-Sided|95.0|-25.96|-10.78||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639371|NCT01942668|3012176|Superiority||Mean Difference (Final Values)|-21.01|Standard Error of the Mean|3.93|<|0.001|2-Sided|95.0|-28.72|-13.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639372|NCT01942668|3012177|Superiority||Mean Difference (Final Values)|-14.28|Standard Error of the Mean|3.78|<|0.001|2-Sided|95.0|-21.7|-6.87||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639373|NCT01942668|3012177|Superiority||Mean Difference (Final Values)|-12.97|Standard Error of the Mean|3.82|<|0.001|2-Sided|95.0|-20.49|-5.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639374|NCT01942668|3012177|Superiority||Mean Difference (Final Values)|-17.92|Standard Error of the Mean|3.8|<|0.001|2-Sided|95.0|-25.39|-10.45||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639375|NCT01942668|3012177|Superiority||Mean Difference (Final Values)|-20.34|Standard Error of the Mean|3.87|<|0.001|2-Sided|95.0|-27.93|-12.74||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639376|NCT01942668|3012178|Superiority||Mean Difference (Final Values)|-13.82|Standard Error of the Mean|3.75|<|0.001|2-Sided|95.0|-21.19|-6.46||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639377|NCT01942668|3012178|Superiority||Mean Difference (Final Values)|-11.49|Standard Error of the Mean|3.8|<|0.003|2-Sided|95.0|-18.95|-4.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639378|NCT01942668|3012178|Superiority||Mean Difference (Final Values)|-15.37|Standard Error of the Mean|3.78|<|0.001|2-Sided|95.0|-22.8|-7.95||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639379|NCT01942668|3012178|Superiority||Mean Difference (Final Values)|-20.52|Standard Error of the Mean|3.84|<|0.001|2-Sided|95.0|-28.06|-12.97||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639380|NCT01942668|3012179|Superiority||Mean Difference (Final Values)|-15.73|Standard Error of the Mean|3.69|<|0.001|2-Sided|95.0|-22.97|-8.49||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639381|NCT01942668|3012179|Superiority||Mean Difference (Final Values)|-12.01|Standard Error of the Mean|3.73|<|0.001|2-Sided|95.0|-19.34|-4.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639382|NCT01942668|3012179|Superiority||Mean Difference (Final Values)|-16.1|Standard Error of the Mean|3.71|<|0.001|2-Sided|95.0|-23.39|-8.8||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639383|NCT01942668|3012179|Superiority||Mean Difference (Final Values)|-21.45|Standard Error of the Mean|3.78|<|0.001|2-Sided|95.0|-28.87|-14.04||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639384|NCT01942668|3012180|Superiority||Mean Difference (Final Values)|-13.85|Standard Error of the Mean|3.71|<|0.001|2-Sided|95.0|-21.13|-6.58||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639385|NCT01942668|3012180|Superiority||Mean Difference (Final Values)|-8.33|Standard Error of the Mean|3.75|<|0.027|2-Sided|95.0|-15.7|-0.96||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639386|NCT01942668|3012180|Superiority||Mean Difference (Final Values)|-12.61|Standard Error of the Mean|3.73|<|0.001|2-Sided|95.0|-19.95|-5.28||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639387|NCT01942668|3012180|Superiority||Mean Difference (Final Values)|-20.32|Standard Error of the Mean|3.8|<|0.001|2-Sided|95.0|-27.77|-12.87||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639388|NCT01942668|3012181|Superiority||Mean Difference (Final Values)|-12.66|Standard Error of the Mean|3.57|<|0.001|2-Sided|95.0|-19.68|-5.65||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639389|NCT01942668|3012181|Superiority||Mean Difference (Final Values)|-6.21|Standard Error of the Mean|3.62|<|0.087|2-Sided|95.0|-13.31|0.89||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639390|NCT01942668|3012181|Superiority||Mean Difference (Final Values)|-10.26|Standard Error of the Mean|3.6|<|0.005|2-Sided|95.0|-17.33|-3.18||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639553|NCT01942590|3012223|Other|||||||0.233||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided||||
1639554|NCT01942590|3012224|Other|||||||0.332|||||||t-test, 1 sided||||
1639391|NCT01942668|3012181|Superiority||Mean Difference (Final Values)|-17.47|Standard Error of the Mean|3.66|<|0.001|2-Sided|95.0|-24.65|-10.28||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639392|NCT01942668|3012182|Superiority||Mean Difference (Final Values)|-11.32|Standard Error of the Mean|3.69||0.002|2-Sided|95.0|-18.57|-4.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639393|NCT01942668|3012182|Superiority||Mean Difference (Final Values)|-4.56|Standard Error of the Mean|3.74||0.223|2-Sided|95.0|-11.9|2.78||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639394|NCT01942668|3012182|Superiority||Mean Difference (Final Values)|-8.92|Standard Error of the Mean|3.73||0.017|2-Sided|95.0|-16.24|-1.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639395|NCT01942668|3012182|Superiority||Mean Difference (Final Values)|-15.32|Standard Error of the Mean|3.78|<|0.001|2-Sided|95.0|-22.75|-7.89||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639396|NCT01942668|3012183|Superiority||Mean Difference (Final Values)|-7.86|Standard Error of the Mean|3.42||0.022|2-Sided|95.0|-14.58|-1.15||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639397|NCT01942668|3012183|Superiority||Mean Difference (Final Values)|-2.95|Standard Error of the Mean|3.46||0.394|2-Sided|95.0|-9.75|3.84||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639398|NCT01942668|3012183|Superiority||Mean Difference (Final Values)|-3.75|Standard Error of the Mean|3.45||0.277|2-Sided|95.0|-10.53|3.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639399|NCT01942668|3012183|Superiority||Mean Difference (Final Values)|-10.38|Standard Error of the Mean|3.5||0.003|2-Sided|95.0|-17.26|-3.5||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639400|NCT01942668|3012184|Superiority||Mean Difference (Final Values)|-4.14|Standard Error of the Mean|3.35||0.216|2-Sided|95.0|-10.72|2.43||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639401|NCT01942668|3012184|Superiority||Mean Difference (Final Values)|2.33|Standard Error of the Mean|3.39||0.492|2-Sided|95.0|-4.32|8.98||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639402|NCT01942668|3012184|Superiority||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|3.38||0.982|2-Sided|95.0|-6.7|6.55||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639403|NCT01942668|3012184|Superiority||Mean Difference (Final Values)|-5.07|Standard Error of the Mean|3.43||0.14|2-Sided|95.0|-11.8|1.67||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639404|NCT01942668|3012185|Superiority||Mean Difference (Final Values)|-3.55|Standard Error of the Mean|2.81||0.207|2-Sided|95.0|-9.07|1.97||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639405|NCT01942668|3012185|Superiority||Mean Difference (Final Values)|2.09|Standard Error of the Mean|2.85||0.463|2-Sided|95.0|-3.5|7.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639406|NCT01942668|3012185|Superiority||Mean Difference (Final Values)|0.55|Standard Error of the Mean|2.83||0.847|2-Sided|95.0|-5.01|6.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639407|NCT01942668|3012185|Superiority||Mean Difference (Final Values)|0.49|Standard Error of the Mean|2.88||0.865|2-Sided|95.0|-5.16|6.14||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639408|NCT01942668|3012186|Superiority||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.098||0.096|2-Sided|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639409|NCT01942668|3012186|Superiority||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.1||0.018|2-Sided|95.0|-0.43|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639410|NCT01942668|3012186|Superiority||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.099|<|0.001|2-Sided|95.0|-0.59|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639411|NCT01942668|3012186|Superiority||Mean Difference (Final Values)|-0.57|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.77|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639412|NCT01942668|3012187|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.096||0.076|2-Sided|95.0|-0.36|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639555|NCT01942590|3012224|Other|||||||0.2074|||||||t-test, 1 sided||||
1639556|NCT01942590|3012225|Other|||||||0.3318||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided||||
1639413|NCT01942668|3012187|Superiority||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.097||0.011|2-Sided|95.0|-0.44|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639414|NCT01942668|3012187|Superiority||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.096|<|0.001|2-Sided|95.0|-0.56|-0.19||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639415|NCT01942668|3012187|Superiority||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.098|<|0.001|2-Sided|95.0|-0.72|-0.34||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639416|NCT01942668|3012188|Superiority||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.094||0.31|2-Sided|95.0|-0.28|0.09||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639417|NCT01942668|3012188|Superiority||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.095||0.016|2-Sided|95.0|-0.41|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639418|NCT01942668|3012188|Superiority||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.094||0.003|2-Sided|95.0|-0.46|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639419|NCT01942668|3012188|Superiority||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.096|<|0.001|2-Sided|95.0|-0.71|-0.33||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639420|NCT01942668|3012189|Superiority||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.09||0.007|2-Sided|95.0|-0.42|-0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639421|NCT01942668|3012189|Superiority||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.091||0.009|2-Sided|95.0|-0.42|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639422|NCT01942668|3012189|Superiority||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.09||0.001|2-Sided|95.0|-0.47|-0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639423|NCT01942668|3012189|Superiority||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.092|<|0.001|2-Sided|95.0|-0.66|-0.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639424|NCT01942668|3012190|Superiority||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.085||0.092|2-Sided|95.0|-0.31|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639425|NCT01942668|3012190|Superiority||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.086||0.087|2-Sided|95.0|-0.32|0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639426|NCT01942668|3012190|Superiority||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.086||0.008|2-Sided|95.0|-0.4|-0.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639427|NCT01942668|3012190|Superiority||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.087|<|0.001|2-Sided|95.0|-0.55|-0.21||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639428|NCT01942668|3012191|Superiority||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.083||0.016|2-Sided|95.0|-0.36|-0.04||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639429|NCT01942668|3012191|Superiority||Mean Difference (Final Values)|-0.18|Standard Error of the Mean|0.084||0.031|2-Sided|95.0|-0.34|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639430|NCT01942668|3012191|Superiority||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.083||0.002|2-Sided|95.0|-0.42|-0.09||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639431|NCT01942668|3012191|Superiority||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.085|<|0.001|2-Sided|95.0|-0.54|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639432|NCT01942668|3012192|Superiority||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.082||0.022|2-Sided|95.0|-0.35|-0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639433|NCT01942668|3012192|Superiority||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.083||0.247|2-Sided|95.0|-0.26|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639434|NCT01942668|3012192|Superiority||Mean Difference (Final Values)|-0.18|Standard Error of the Mean|0.083||0.03|2-Sided|95.0|-0.34|-0.02||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639435|NCT01942668|3012192|Superiority||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|0.084|<|0.001|2-Sided|95.0|-0.53|-0.2||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639557|NCT01942590|3012225|Other|||||||0.0816||||||Paired t test comparing each subject's performance at Week 52 to Baseline|t-test, 1 sided||||
1639436|NCT01942668|3012193|Superiority||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.069||0.086|2-Sided|95.0|-0.25|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639437|NCT01942668|3012193|Superiority||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.07||0.79|2-Sided|95.0|-0.16|0.12||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639438|NCT01942668|3012193|Superiority||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.07||0.034|2-Sided|95.0|-0.28|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639439|NCT01942668|3012193|Superiority||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.071||0.001|2-Sided|95.0|-0.37|-0.09||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639440|NCT01942668|3012194|Superiority||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.059||0.1|2-Sided|95.0|-0.21|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639441|NCT01942668|3012194|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.06||0.401|2-Sided|95.0|-0.17|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639442|NCT01942668|3012194|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.06||0.005|2-Sided|95.0|-0.28|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639443|NCT01942668|3012194|Superiority||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.061||0.031|2-Sided|95.0|-0.25|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639444|NCT01942668|3012195|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.051||0.309|2-Sided|95.0|-0.15|0.05||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639445|NCT01942668|3012195|Superiority||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.052||0.946|2-Sided|95.0|-0.1|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639446|NCT01942668|3012195|Superiority||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.052||0.03|2-Sided|95.0|-0.21|-0.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639447|NCT01942668|3012195|Superiority||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.052||0.039|2-Sided|95.0|-0.21|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639448|NCT01942668|3012196|Superiority||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.042||0.849|2-Sided|95.0|-0.09|0.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639449|NCT01942668|3012196|Superiority||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.042||0.717|2-Sided|95.0|-0.07|0.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639450|NCT01942668|3012196|Superiority||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.042||0.173|2-Sided|95.0|-0.14|0.03||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639451|NCT01942668|3012196|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.043||0.231|2-Sided|95.0|-0.14|0.03||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639452|NCT01942668|3012197|Superiority||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.034||0.928|2-Sided|95.0|-0.07|0.06||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639453|NCT01942668|3012197|Superiority||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.034||0.642|2-Sided|95.0|-0.05|0.08||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639454|NCT01942668|3012197|Superiority||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.034||0.991|2-Sided|95.0|-0.07|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639455|NCT01942668|3012197|Superiority||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.034||0.801|2-Sided|95.0|-0.06|0.08||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639456|NCT01942668|3012198|Superiority||Mean Difference (Final Values)|-11.71|Standard Error of the Mean|3.36|<|0.001|2-Sided|95.0|-18.31|-5.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639457|NCT01942668|3012198|Superiority||Mean Difference (Final Values)|-10.79|Standard Error of the Mean|3.41|<|0.002|2-Sided|95.0|-17.48|-4.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639458|NCT01942668|3012198|Superiority||Mean Difference (Final Values)|-15.07|Standard Error of the Mean|3.39|<|0.001|2-Sided|95.0|-21.72|-8.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639558|NCT01942590|3012226|Other|||||||0.434|||||||t-test, 1 sided||||
1639459|NCT01942668|3012198|Superiority||Mean Difference (Final Values)|-16.58|Standard Error of the Mean|3.44|<|0.001|2-Sided|95.0|-23.33|-9.82||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639460|NCT01942668|3012199|Superiority||Mean Difference (Final Values)|-13.6|Standard Error of the Mean|3.39|<|0.001|2-Sided|95.0|-20.26|-6.93||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639461|NCT01942668|3012199|Superiority||Mean Difference (Final Values)|-12.41|Standard Error of the Mean|3.44|<|0.001|2-Sided|95.0|-19.15|-5.66||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639462|NCT01942668|3012199|Superiority||Mean Difference (Final Values)|-16.45|Standard Error of the Mean|3.42|<|0.001|2-Sided|95.0|-23.17|-9.74||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639463|NCT01942668|3012199|Superiority||Mean Difference (Final Values)|-18.11|Standard Error of the Mean|3.47|<|0.001|2-Sided|95.0|-24.92|-11.29||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 11|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639464|NCT01942668|3012200|Superiority||Mean Difference (Final Values)|-12.16|Standard Error of the Mean|3.37|<|0.001|2-Sided|95.0|-18.78|-5.55||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639465|NCT01942668|3012200|Superiority||Mean Difference (Final Values)|-11.2|Standard Error of the Mean|3.41|<|0.001|2-Sided|95.0|-17.9|-4.49||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639466|NCT01942668|3012200|Superiority||Mean Difference (Final Values)|-15.66|Standard Error of the Mean|3.4|<|0.001|2-Sided|95.0|-22.32|-8.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639467|NCT01942668|3012200|Superiority||Mean Difference (Final Values)|-16.8|Standard Error of the Mean|3.45|<|0.001|2-Sided|95.0|-23.58|-10.03||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 10|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639468|NCT01942668|3012201|Superiority||Mean Difference (Final Values)|-13.02|Standard Error of the Mean|3.32|<|0.001|2-Sided|95.0|-19.54|-6.5||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639469|NCT01942668|3012201|Superiority||Mean Difference (Final Values)|-11.05|Standard Error of the Mean|3.36|<|0.001|2-Sided|95.0|-17.65|-4.44||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639470|NCT01942668|3012201|Superiority||Mean Difference (Final Values)|-15.58|Standard Error of the Mean|3.34|<|0.001|2-Sided|95.0|-22.15|-9.01||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639471|NCT01942668|3012201|Superiority||Mean Difference (Final Values)|-17.12|Standard Error of the Mean|3.4|<|0.001|2-Sided|95.0|-23.79|-10.44||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 9|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639472|NCT01942668|3012202|Superiority||Mean Difference (Final Values)|-11.97|Standard Error of the Mean|3.34|<|0.001|2-Sided|95.0|-18.53|-5.41||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639473|NCT01942668|3012202|Superiority||Mean Difference (Final Values)|-9.63|Standard Error of the Mean|3.38|<|0.005|2-Sided|95.0|-16.27|-2.99||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639474|NCT01942668|3012202|Superiority||Mean Difference (Final Values)|-12.97|Standard Error of the Mean|3.37|<|0.001|2-Sided|95.0|-19.58|-6.36||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639475|NCT01942668|3012202|Superiority||Mean Difference (Final Values)|-16.63|Standard Error of the Mean|3.42|<|0.001|2-Sided|95.0|-23.35|-9.91||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 8|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639476|NCT01942668|3012203|Superiority||Mean Difference (Final Values)|-13.61|Standard Error of the Mean|3.33|<|0.001|2-Sided|95.0|-20.15|-7.07||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639477|NCT01942668|3012203|Superiority||Mean Difference (Final Values)|-10.22|Standard Error of the Mean|3.37|<|0.003|2-Sided|95.0|-16.83|-3.6||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639478|NCT01942668|3012203|Superiority||Mean Difference (Final Values)|-13.29|Standard Error of the Mean|3.36|<|0.001|2-Sided|95.0|-19.88|-6.7||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639479|NCT01942668|3012203|Superiority||Mean Difference (Final Values)|-17.75|Standard Error of the Mean|3.41|<|0.001|2-Sided|95.0|-24.45|-11.06||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 7|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639480|NCT01942668|3012204|Superiority||Mean Difference (Final Values)|-12.51|Standard Error of the Mean|3.36|<|0.001|2-Sided|95.0|-19.11|-5.91||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639559|NCT01942590|3012226|Other|||||||0.0512|||||||t-test, 1 sided||||
1639619|NCT01941940|3012271|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 24|
1639481|NCT01942668|3012204|Superiority||Mean Difference (Final Values)|-7.82|Standard Error of the Mean|3.4|<|0.022|2-Sided|95.0|-14.5|-1.14||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639482|NCT01942668|3012204|Superiority||Mean Difference (Final Values)|-11.35|Standard Error of the Mean|3.39|<|0.001|2-Sided|95.0|-18.0|-4.7||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639483|NCT01942668|3012204|Superiority||Mean Difference (Final Values)|-17.87|Standard Error of the Mean|3.44|<|0.001|2-Sided|95.0|-24.57|-11.05||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 6|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639484|NCT01942668|3012205|Superiority||Mean Difference (Final Values)|-12.05|Standard Error of the Mean|3.27|<|0.001|2-Sided|95.0|-18.47|-5.64||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639485|NCT01942668|3012205|Superiority||Mean Difference (Final Values)|-5.9|Standard Error of the Mean|3.31|<|0.075|2-Sided|95.0|-12.4|0.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639486|NCT01942668|3012205|Superiority||Mean Difference (Final Values)|-9.88|Standard Error of the Mean|3.29|<|0.003|2-Sided|95.0|-16.34|-3.41||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639487|NCT01942668|3012205|Superiority||Mean Difference (Final Values)|-15.59|Standard Error of the Mean|3.35|<|0.001|2-Sided|95.0|-22.16|-9.02||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 5|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639488|NCT01942668|3012206|Superiority||Mean Difference (Final Values)|-10.4|Standard Error of the Mean|3.22||0.001|2-Sided|95.0|-16.73|-4.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639489|NCT01942668|3012206|Superiority||Mean Difference (Final Values)|-4.81|Standard Error of the Mean|3.26||0.141|2-Sided|95.0|-11.21|1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639490|NCT01942668|3012206|Superiority||Mean Difference (Final Values)|-8.07|Standard Error of the Mean|3.25||0.013|2-Sided|95.0|-14.46|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639491|NCT01942668|3012206|Superiority||Mean Difference (Final Values)|-12.81|Standard Error of the Mean|3.3|<|0.001|2-Sided|95.0|-19.29|-6.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639492|NCT01942668|3012207|Superiority||Mean Difference (Final Values)|-7.24|Standard Error of the Mean|3.08||0.019|2-Sided|95.0|-13.28|-1.19||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639493|NCT01942668|3012207|Superiority||Mean Difference (Final Values)|-1.65|Standard Error of the Mean|3.12||0.597|2-Sided|95.0|-7.77|4.47||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639494|NCT01942668|3012207|Superiority||Mean Difference (Final Values)|-3.76|Standard Error of the Mean|3.11||0.227|2-Sided|95.0|-9.86|2.35||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639495|NCT01942668|3012207|Superiority||Mean Difference (Final Values)|-8.56|Standard Error of the Mean|3.16||0.007|2-Sided|95.0|-14.75|-2.36||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 3|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639496|NCT01942668|3012208|Superiority||Mean Difference (Final Values)|-2.77|Standard Error of the Mean|2.98||0.353|2-Sided|95.0|-8.62|3.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639497|NCT01942668|3012208|Superiority||Mean Difference (Final Values)|3.54|Standard Error of the Mean|3.01||0.24|2-Sided|95.0|-2.37|9.46||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639498|NCT01942668|3012208|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|3.0||0.956|2-Sided|95.0|-6.06|5.73||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639499|NCT01942668|3012208|Superiority||Mean Difference (Final Values)|-4.35|Standard Error of the Mean|3.05||0.154|2-Sided|95.0|-10.34|1.64||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 2|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639500|NCT01942668|3012209|Superiority||Mean Difference (Final Values)|-1.93|Standard Error of the Mean|2.46||0.431|2-Sided|95.0|-6.76|2.89||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639501|NCT01942668|3012209|Superiority||Mean Difference (Final Values)|3.17|Standard Error of the Mean|2.49||0.202|2-Sided|95.0|-1.71|8.06||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639502|NCT01942668|3012209|Superiority||Mean Difference (Final Values)|1.29|Standard Error of the Mean|2.47||0.601|2-Sided|95.0|-3.56|6.15||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639612|NCT01941940|3012270|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 24|
1639503|NCT01942668|3012209|Superiority||Mean Difference (Final Values)|1.36|Standard Error of the Mean|2.51||0.588|2-Sided|95.0|-3.57|6.3||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 1|Mixed Models Analysis||Adjusted for baseline using MMRM||
1639504|NCT01942668|3012210|Other|Per FDA guidance hyperplasia proportion must be <=1% with an upper bound of the one-sided 95% confidence interval <=4%.|incidence rate|0.0|||||1-Sided|95.0||3.2|||||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Placebo.|
1639505|NCT01942668|3012210|Other|Per FDA guidance hyperplasia proportion must be <=1% with an upper bound of the one-sided 95% confidence interval <=4%.|incidence rate|0.0|||||1-Sided|95.0||1.09|||||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.25 mg / Progesterone 50 mg.|
1639506|NCT01942668|3012210|Other|Per FDA guidance hyperplasia proportion must be <=1% with an upper bound of the one-sided 95% confidence interval <=4%.|incidence rate|0.0|||||1-Sided|95.0||0.97|||||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 50 mg.|
1639507|NCT01942668|3012210|Other|Per FDA guidance hyperplasia proportion must be <=1% with an upper bound of the one-sided 95% confidence interval <=4%.|incidence rate|0.0|||||1-Sided|95.0||0.98|||||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 100 mg.|
1639508|NCT01942668|3012210|Other|Per FDA guidance hyperplasia proportion must be <=1% with an upper bound of the one-sided 95% confidence interval <=4%.|incidence rate|0.0|||||1-Sided|95.0||1.06|||||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 1 mg / Progesterone 100 mg.|
1639509|NCT01942668|3012211|Other|Per FDA guidance hyperplasia proportion must be <=1% with an upper bound of the one-sided 95% confidence interval <=4%.|incidence rate|0.0|||||1-Sided|95.0||3.2|||||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Placebo.|
1639510|NCT01942668|3012211|Other|Per FDA guidance hyperplasia proportion must be <=1% with an upper bound of the one-sided 95% confidence interval <=4%.|incidence rate|0.0|||||1-Sided|95.0||1.09|||||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.25 mg / Progesterone 50 mg.|
1639511|NCT01942668|3012211|Other|Per FDA guidance hyperplasia proportion must be <=1% with an upper bound of the one-sided 95% confidence interval <=4%.|incidence rate|0.0|||||1-Sided|95.0||0.97|||||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 50 mg.|
1639512|NCT01942668|3012211|Other|Per FDA guidance hyperplasia proportion must be <=1% with an upper bound of the one-sided 95% confidence interval <=4%.|incidence rate|0.0|||||1-Sided|95.0||0.98|||||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 0.5 mg / Progesterone 100 mg.|
1639513|NCT01942668|3012211|Other|Per FDA guidance hyperplasia proportion must be <=1% with an upper bound of the one-sided 95% confidence interval <=4%.|incidence rate|0.0|||||1-Sided|95.0||1.06|||||This calculation is based on a binomial distribution.|Between group comparison is not intended. The purpose of the analysis is to calculate the incidence rate and the 95% CI of endometrial hyperplasia per FDA published guidance for Combined Estradiol 1 mg / Progesterone 100 mg.|
1639514|NCT01942668|3012212|Superiority||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.098||0.096|2-Sided|95.0|-0.36|0.03||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639515|NCT01942668|3012212|Superiority||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.1||0.018|2-Sided|95.0|-0.43|-0.04||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639516|NCT01942668|3012212|Superiority||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.099|<|0.001|2-Sided|95.0|-0.59|-0.2||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639517|NCT01942668|3012212|Superiority||Mean Difference (Final Values)|-0.57|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.77|-0.38||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639518|NCT01942668|3012213|Superiority||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.059||0.1|2-Sided|95.0|-0.21|0.02||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639613|NCT01941940|3012270|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 24|
1639519|NCT01942668|3012213|Superiority||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.06||0.401|2-Sided|95.0|-0.17|0.07||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639520|NCT01942668|3012213|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.06||0.005|2-Sided|95.0|-0.28|-0.05||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639521|NCT01942668|3012213|Superiority||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.061||0.031|2-Sided|95.0|-0.25|-0.01||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639522|NCT01942668|3012214|Superiority||Mean Difference (Final Values)|-11.71|Standard Error of the Mean|3.36|<|0.001|2-Sided|95.0|-18.31|-5.11||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639523|NCT01942668|3012214|Superiority||Mean Difference (Final Values)|-10.79|Standard Error of the Mean|3.41|<|0.002|2-Sided|95.0|-17.48|-4.1||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639524|NCT01942668|3012214|Superiority||Mean Difference (Final Values)|-15.07|Standard Error of the Mean|3.39|<|0.001|2-Sided|95.0|-21.72|-8.42||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639525|NCT01942668|3012214|Superiority||Mean Difference (Final Values)|-16.58|Standard Error of the Mean|3.44|<|0.001|2-Sided|95.0|-23.33|-9.82||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 12|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639526|NCT01942668|3012215|Superiority||Mean Difference (Final Values)|-10.4|Standard Error of the Mean|3.22||0.001|2-Sided|95.0|-16.73|-4.08||p-value is derived from comparison between Combined Estradiol 0.25 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639527|NCT01942668|3012215|Superiority||Mean Difference (Final Values)|-4.81|Standard Error of the Mean|3.26||0.141|2-Sided|95.0|-11.21|1.59||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 50 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639528|NCT01942668|3012215|Superiority||Mean Difference (Final Values)|-8.07|Standard Error of the Mean|3.25||0.013|2-Sided|95.0|-14.46|-1.68||p-value is derived from comparison between Combined Estradiol 0.5 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639529|NCT01942668|3012215|Superiority||Mean Difference (Final Values)|-12.81|Standard Error of the Mean|3.3|<|0.001|2-Sided|95.0|-19.29|-6.32||p-value is derived from comparison between Combined Estradiol 1 mg / Progesterone 100 mg against Placebo at Week 4|Mixed Models Analysis|Each co-primary endpt in each dose group tested at alpha=0.05;multiple dose groups vs. PBO comparisons are conducted using gatekeeping procedure|Adjusted for baseline using MMRM||
1639530|NCT01942590|3012216|Other|||||||0.118|||||||t-test, 1 sided|||Baseline, Week 52|
1639531|NCT01942590|3012216|Other|||||||0.152|||||||t-test, 1 sided|||Baseline, Week 18|
1639532|NCT01942590|3012216|Other|||||||0.059|||||||t-test, 1 sided|||Baseline, Week 52|
1639533|NCT01942590|3012216|Other|||||||0.479|||||||t-test, 1 sided|||Baseline, Week 18|
1639534|NCT01942590|3012217|Other|||||||0.279|||||||t-test, 1 sided|||Baseline, Week 52|
1639535|NCT01942590|3012217|Other|||||||0.286|||||||t-test, 1 sided|||Baseline, Week 18|
1639536|NCT01942590|3012217|Other|||||||0.0036|||||||t-test, 1 sided|||Baseline, Week 52|
1639537|NCT01942590|3012217|Other|||||||0.268|||||||t-test, 1 sided|||Baseline, Week 18|
1639538|NCT01942590|3012218|Other|||||||0.0371|||||||t-test, 1 sided|||Baseline, Week 52|
1639539|NCT01942590|3012218|Other|||||||0.3639|||||||t-test, 1 sided|||Baseline Week 18|
1639540|NCT01942590|3012219|Other|||||||0.196|||||||t-test, 1 sided|||Baseline, Week 52|
1639541|NCT01942590|3012219|Other|||||||0.297|||||||t-test, 1 sided|||Baseline, Week 18|
1639542|NCT01942590|3012219|Other|||||||0.007|||||||t-test, 1 sided|||Baseline, Week 52|
1639543|NCT01942590|3012219|Other|||||||0.006|||||||t-test, 1 sided|||Baseline, Week 18|
1639544|NCT01942590|3012220|Other|||||||0.211|||||||t-test, 1 sided|||Baseline, Week 52|
1639545|NCT01942590|3012220|Other|||||||0.154|||||||t-test, 1 sided|||Baseline, week 18|
1639546|NCT01942590|3012220|Other|||||||0.004|||||||t-test, 1 sided|||Baseline, week 52|
1639547|NCT01942590|3012220|Other|||||||0.01|||||||t-test, 1 sided|||Baseline, week 18|
1639548|NCT01942590|3012221|Other|||||||0.43|||||||t-test, 1 sided||||
1639549|NCT01942590|3012221|Other|||||||0.161|||||||t-test, 1 sided||||
1639550|NCT01942590|3012222|Other|||||||0.366|||||||t-test, 1 sided||||
1639551|NCT01942590|3012222|Other|||||||0.019|||||||t-test, 1 sided||||
1641989|NCT01884545|3018050|Superiority|||||||0.9631|||||||Regression, Linear||||
1639560|NCT01942135|3012239|Superiority or Other (legacy)||Hazard Ratio (HR)|0.642|||<|0.001|2-Sided|95.0|0.487|0.846||The priori threshold for statistical significance is 1-sided alpha=0.025. The p-value was not adjusted for multiple comparisons.|Unstratified log-rank test (1-sided)|1-sided p-value from the unstratified log-rank test.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of the palbociclib plus fulvestrant arm.|Treatment with palbociclib plus fulvestrant significantly delayed TTD in pain symptom compared with placebo plus fulvestrant for unstratified analysis.|
1639561|NCT01942135|3012240|Superiority or Other (legacy)||Mean Difference (Final Values)|0.8||||0.5523|2-Sided|95.0|-1.9|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|
1639562|NCT01942135|3012241|Superiority or Other (legacy)||Mean Difference (Final Values)|0.037||||0.0308|2-Sided|95.0|0.0|0.07||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|
1639563|NCT01942135|3012242|Superiority or Other (legacy)||Mean Difference (Final Values)|8.9||||0.0255|2-Sided|95.0|1.1|16.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for upset by hair loss|
1639564|NCT01942135|3012242|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.2||||0.875|2-Sided|95.0|-2.6|2.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for arm symptoms|
1639565|NCT01942135|3012242|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.9||||0.2671|2-Sided|95.0|-2.6|0.7||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for breast symptoms|
1639566|NCT01942135|3012242|Superiority or Other (legacy)||Mean Difference (Final Values)|0.4||||0.7273|2-Sided|95.0|-1.6|2.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for systemic therapy side effects|
1639567|NCT01942135|3012243|Superiority or Other (legacy)||Mean Difference (Final Values)|3.6||||0.0845|2-Sided|95.0|-0.5|7.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for future perspective|
1639568|NCT01942135|3012243|Superiority or Other (legacy)||Mean Difference (Final Values)|1.4||||0.6271|2-Sided|95.0|-4.4|7.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for sexual enjoyment|
1639569|NCT01942135|3012243|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.8||||0.5235|2-Sided|95.0|-3.1|1.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for sexual functioning|
1639570|NCT01942135|3012243|Superiority or Other (legacy)||Mean Difference (Final Values)|2.3||||0.1386|2-Sided|95.0|-0.7|5.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for body image|
1639571|NCT01942135|3012244|Superiority or Other (legacy)||Mean Difference (Final Values)|0.3||||0.8812|2-Sided|95.0|-3.1|3.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for financial difficulties|
1639572|NCT01942135|3012244|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.6||||0.6293|2-Sided|95.0|-2.8|1.7||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for diarrhoea|
1639614|NCT01941940|3012270|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 24|
1639615|NCT01941940|3012270|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 2|
1639573|NCT01942135|3012244|Superiority or Other (legacy)||Mean Difference (Final Values)|0.7||||0.6491|2-Sided|95.0|-2.5|3.9||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for constipation|
1639574|NCT01942135|3012244|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.6||||0.7334|2-Sided|95.0|-4.1|2.9||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for appetite loss|
1639575|NCT01942135|3012244|Superiority or Other (legacy)||Mean Difference (Final Values)|-2.0||||0.2721|2-Sided|95.0|-5.5|1.6||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for insomnia|
1639576|NCT01942135|3012244|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.5||||0.7699|2-Sided|95.0|-3.7|2.8||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for dyspnoea|
1639577|NCT01942135|3012244|Superiority or Other (legacy)||Mean Difference (Final Values)|-5.3||||0.0011|2-Sided|95.0|-8.5|-2.1||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for pain|
1639578|NCT01942135|3012244|Superiority or Other (legacy)||Mean Difference (Final Values)|-2.5||||0.0369|2-Sided|95.0|-4.8|-0.2||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for nausea and vomiting|
1639579|NCT01942135|3012244|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.5||||0.32|2-Sided|95.0|-4.5|1.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for fatigue|
1639580|NCT01942135|3012245|Superiority or Other (legacy)||Mean Difference (Final Values)|0.1||||0.9615|2-Sided|95.0|-3.4|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for social functioning|
1639581|NCT01942135|3012245|Superiority or Other (legacy)||Mean Difference (Final Values)|1.2||||0.365|2-Sided|95.0|-1.4|3.8||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for cognitive functioning|
1639582|NCT01942135|3012245|Superiority or Other (legacy)||Mean Difference (Final Values)|4.6||||0.0016|2-Sided|95.0|1.7|7.4||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for emotional functioning|
1639583|NCT01942135|3012245|Superiority or Other (legacy)||Mean Difference (Final Values)|1.9||||0.2615|2-Sided|95.0|-1.5|5.3||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for role functioning|
1639584|NCT01942135|3012245|Superiority or Other (legacy)||Mean Difference (Final Values)|1.0||||0.4|2-Sided|95.0|-1.4|3.5||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for physical functioning|
1639585|NCT01942135|3012245|Superiority or Other (legacy)||Mean Difference (Final Values)|3.1||||0.0313|2-Sided|95.0|0.3|6.0||The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.|Mixed Model Analysis (2-sided)|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.||Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for Global health status/ QoL|
1639616|NCT01941940|3012270|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 2|
1639617|NCT01941940|3012270|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 2|
1639618|NCT01941940|3012271|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 52|
1639586|NCT01942135|3012250|Superiority or Other (legacy)||Odds Ratio (OR)|2.189||||0.0002|2-Sided|95.0|1.391|3.523||The p-value was not adjusted for multiple comparisons. The priori threshold for statistical significance is 1-sided, alpha=0.025.|Exact test (1-sided)|The 1-sided p-value is from the stratified exact test.|An odds ratio > 1 means better clinical benefit response in favor of palbociclib plus fulvestrant arm.|The exact test is testing the null hypothesis that the odds ratio of objective response rate is less than or equal to 1 vs. the alternative hypothesis that the odds ratio of objective response rate is greater than 1. An Odds Ratio >1 means better response in favor of palbociclib plus fulvestrant arm.|
1639587|NCT01942135|3012252|Superiority or Other (legacy)||Odds Ratio (OR)|1.725||||0.0791|2-Sided|95.0|0.835|3.896||The p-value was not adjusted for multiple comparisons. The priori threshold for statistical significance is 1-sided, alpha=0.025.|Exact test (1-sided)|The 1-sided p-value is from the stratified exact test.|An Odds Ratio >1 means better response in favor of the palbociclib plus fulvestrant arm.|The exact test is testing the null hypothesis that the odds ratio of objective response rate is less than or equal to 1 vs. the alternative hypothesis that the odds ratio of objective response rate is greater than 1. An Odds Ratio >1 means better response in favor of palbociclib plus fulvestrant arm.|
1639588|NCT01942135|3012254|Superiority or Other (legacy)||Hazard Ratio (HR)|0.422|||<|1e-06|2-Sided|95.0|0.318|0.56||The overall Type-I error rate was persevered at 1-sided 0.025 level for the analysis of the primary endpoint PFS by the Haybittle-Peto efficacy boundary. The priori threshold for statistical significance at the interim analysis was 0.00135.|Stratified Log Rank Test (1-sided)|The log rank test stratified by sensitivity to prior hormonal therapy and the presence of visceral metastases based on the randomization information.|Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of the palbociclib plus fulvestrant arm.|The primary hypothesis to be tested was H0: λ≥1 versus. HA: λ<1, where λ was the palbociclib plus fulvestrant: placebo plus fulvestrant hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Fulvestrant. The study was planned to have 90% power and control the type-I error rate at 0.025.|
1639589|NCT01941940|3012260|Superiority or Other|||||||0.1992|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639590|NCT01941940|3012260|Superiority or Other|||||||0.0045|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639591|NCT01941940|3012261|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639592|NCT01941940|3012261|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639593|NCT01941940|3012261|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639594|NCT01941940|3012263|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639595|NCT01941940|3012263|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639596|NCT01941940|3012263|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639597|NCT01941940|3012264|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639598|NCT01941940|3012264|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639599|NCT01941940|3012264|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639600|NCT01941940|3012265|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639601|NCT01941940|3012265|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639602|NCT01941940|3012265|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639603|NCT01941940|3012266|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639604|NCT01941940|3012266|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639605|NCT01941940|3012266|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639606|NCT01941940|3012269|Superiority or Other|||||||0.0016|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 52|
1639607|NCT01941940|3012269|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 24|
1639608|NCT01941940|3012269|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and EULAR at Week 2|
1639609|NCT01941940|3012270|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR70 at Week 52|
1639610|NCT01941940|3012270|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR50 at Week 52|
1639611|NCT01941940|3012270|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between SDAI and ACR20 at Week 52|
1639620|NCT01941940|3012271|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and EULAR at Week 2|
1639621|NCT01941940|3012272|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 52|
1639622|NCT01941940|3012272|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 52|
1639623|NCT01941940|3012272|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 52|
1639624|NCT01941940|3012272|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 24|
1639625|NCT01941940|3012272|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 24|
1639626|NCT01941940|3012272|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 24|
1639627|NCT01941940|3012272|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR70 at Week 2|
1639628|NCT01941940|3012272|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR50 at Week 2|
1639629|NCT01941940|3012272|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and ACR20 at Week 2|
1639630|NCT01941940|3012273|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 52|
1639631|NCT01941940|3012273|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 24|
1639632|NCT01941940|3012273|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and EULAR at Week 2|
1639633|NCT01941940|3012274|Superiority or Other|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 52|
1639634|NCT01941940|3012274|Superiority or Other|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 52|
1639635|NCT01941940|3012274|Superiority or Other|||||||0.0004|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 52|
1639636|NCT01941940|3012274|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 24|
1639637|NCT01941940|3012274|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 24|
1639638|NCT01941940|3012274|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 24|
1639639|NCT01941940|3012274|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR70 at Week 2|
1639640|NCT01941940|3012274|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR50 at Week 2|
1639641|NCT01941940|3012274|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and ACR20 at Week 2|
1639642|NCT01941940|3012275|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 52|
1639643|NCT01941940|3012275|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 24|
1639644|NCT01941940|3012275|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between CDAI and SDAI at Week 2|
1639645|NCT01941940|3012276|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 52|
1639646|NCT01941940|3012276|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 24|
1639647|NCT01941940|3012276|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and SDAI at Week 2|
1639648|NCT01941940|3012277|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 52|
1639649|NCT01941940|3012277|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 24|
1639650|NCT01941940|3012277|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis for association between DAS28-ESR and CDAI at Week 2|
1639651|NCT01941940|3012278|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639652|NCT01941940|3012278|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639653|NCT01941940|3012278|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-28: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639654|NCT01941940|3012278|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639655|NCT01941940|3012278|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639656|NCT01941940|3012278|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||SJC-66: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639657|NCT01941940|3012279|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639658|NCT01941940|3012279|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639659|NCT01941940|3012279|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-28: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639660|NCT01941940|3012279|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639661|NCT01941940|3012279|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639662|NCT01941940|3012279|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||TJC-68: Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639663|NCT01941940|3012282|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639664|NCT01941940|3012282|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639665|NCT01941940|3012282|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639666|NCT01941940|3012283|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 52 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639667|NCT01941940|3012283|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639668|NCT01941940|3012283|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639669|NCT01941940|3012285|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 2 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639670|NCT01941940|3012291|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum and Signed Rank Tests|||Analysis for change from baseline to Week 24 was performed using Wilcoxon Rank Sum and Signed Rank Tests for dependent sample.|
1639671|NCT01941030|3012376|Other|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.205|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-final balloon FFR value with 1200 mcg adenosine.|
1639672|NCT01941030|3012376|Other|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.076|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-final balloon FFR value with 600 mcg adenosine.|
1639673|NCT01941030|3012377|Other|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.0579|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty fibrofatty plaque area.|
1639674|NCT01941030|3012378|Other|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.2149|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty fibrous plaque area.|
1639675|NCT01941030|3012379|Other|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.6073|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty necrotic core area.|
1639676|NCT01941030|3012380|Other|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.3573|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty dense calcium area.|
1639677|NCT01941030|3012381|Other|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.4528|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty plaque area.|
1639678|NCT01941030|3012382|Other|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.6228|||||||t-test, 2 sided|||Null hypothesis: no difference in populations for post-balloon angioplasty minimum lumen area stenosis.|
1639679|NCT01941030|3012383|Other|No pre-specified hypothesis test or power calculation specified in protocol.||||||0.022|||||||Wilcoxon (Mann-Whitney)|Data failed to meet the assumption for normality per the Shapiro-Wilk test.||Null hypothesis: no difference in populations for post-balloon angioplasty reduction of calcium out of lumen gain.|
1639680|NCT01940705|3012388|Superiority||Mean Difference (Final Values)|0.27||||0.847|2-Sided||||||ANOVA||||
1639681|NCT01940705|3012389|Superiority||Mean Difference (Final Values)|0.956||||0.414|2-Sided||||||ANOVA||||
1639682|NCT01940705|3012390|Superiority||Mean Difference (Final Values)|4.235||||0.003|2-Sided||||||ANOVA|||Analysis for Hearing Aid Skills and Knowledge test Knowledge scale|
1639683|NCT01940705|3012390|Superiority||Mean Difference (Final Values)|5.578||||0.001|2-Sided||||||ANOVA|||Analysis for Hearing Aid Skills and Knowledge test Skills scale|
1639684|NCT01940510|3012403|Superiority or Other||Geometric Least Square Mean Ratio|220.0|||||2-Sided|90.0|190.0|255.0|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.||
1639685|NCT01940510|3012404|Superiority or Other||Geometric Least Square Mean Ratio|179.0|||||2-Sided|90.0|158.0|202.0|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.||
1639686|NCT01940510|3012405|Superiority or Other||Geometric Least Square Mean Ratio|48.6|||||2-Sided|90.0|43.5|54.3|||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals. The reported values are percentages of geometric least square mean ratio.||
1639687|NCT01940510|3012406|Superiority or Other||Geometric Least Square Mean Ratio|26.8|||||2-Sided|90.0|23.8|30.1|||||The reported values are percentages of geometric least square mean ratio.|Analysis of variance (ANOVA) was applied to the log-transformed PK parameters, and then back transformed to provide geometric least square mean ratios (Period 3/Period 1) and confidence intervals.|
1639688|NCT01940471|3012438|Non-Inferiority or Equivalence (legacy)|Sample sizes of 288 and 576 participants in the TDF and TAF groups, respectively, were planned to give 84% power to rule out the noninferiority margin of 10% at a 1-sided significance level of 0.025. This sample size based on the assumption that the expected difference (TAF − TDF) in the proportion of participants with HBV DNA < 29 IU/mL was 0 and the proportion of participants with HBV DNA < 29 IU/mL in the TDF group was 69%. Missing data were treated as not achieving the primary endpoint .|Difference in proportions|-3.6|||||2-Sided|95.0|-9.8|2.6|||||Difference in the proportion between treatment groups and its 95% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HBV DNA categories and oral antiviral treatment status strata.|The null hypothesis was that the TAF group is at least 10% worse than the TDF group with respect to the proportion of participants with HBV DNA < 29 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 10% worse than the TDF group with respect to the proportion of participants with HBV DNA < 29 IU/mL at Week 48. Noninferiority was assessed using a 95% confidence interval (CI) approach, with a noninferiority margin of 10%.|
1639689|NCT01940341|3012446|Non-Inferiority or Equivalence (legacy)|Sample sizes of 130 and 260 participants in the TDF group and TAF groups, respectively were planned to give 90% power to rule out the noninferiority margin of 10% at a 1-sided significance level of 0.025. This sample size was based on the assumption that the expected difference (TAF−TDF) in proportion of participants with HBV DNA<29 IU/mL was 0 and the proportion of participants with HBV DNA<29 IU/mL in the TDF group was 91%. All missing data were treated as not achieving the primary endpoint.|Difference in proportions|1.8|||||2-Sided|95.0|-3.6|7.2|||||Difference in the proportion between treatment groups and its 95% CI were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HBV DNA categories and oral antiviral treatment status strata.|The null hypothesis was that the TAF group is at least 10% worse than the TDF group with respect to the proportion of participants with HBV DNA < 29 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 10% worse than the TDF group with respect to the proportion of participants with HBV DNA < 29 IU/mL at Week 48. Noninferiority was assessed using a 95% confidence interval (CI) approach, with a noninferiority margin of 10%.|
1639690|NCT01939977|3012614|Superiority|||||||0.0083|||||||Chi-squared|||"Taking per protocol population, the percentage of patients with iPTH> 110 pg / ml at 6 months post-transplant treated with Paricalcitol was statistically lower than in patients treated with Calcifediol"|
1639691|NCT01939548|3012643|Superiority or Other||LSM Difference|-0.02|Standard Error of the Mean|0.192||0.9315|2-Sided|80.0|-0.26|0.23||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|ANOVA|||Analysis of change at Week 12. Mixed effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site, visit and visit-by-treatment interaction; random effect: participant.|
1639692|NCT01939548|3012643|Superiority or Other||LSM Difference|0.07|Standard Error of the Mean|0.188||0.7219|2-Sided|80.0|-0.17|0.31||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|ANOVA|||Analysis of change at Week 12. Mixed effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site, visit and visit-by-treatment interaction; random effect: participant.|
1639693|NCT01939548|3012644|Superiority or Other||LSM Difference|0.13|Standard Error of the Mean|0.122||0.2747|2-Sided|80.0|-0.02|0.29||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639694|NCT01939548|3012644|Superiority or Other||LSM Difference|0.04|Standard Error of the Mean|0.119||0.7399|2-Sided|80.0|-0.11|0.19||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639695|NCT01939548|3012645|Superiority or Other||LSM Difference|-0.44|Standard Error of the Mean|0.441||0.3202|2-Sided|80.0|-1.01|0.13||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Uncontrolled hostility/excitement symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639696|NCT01939548|3012645|Superiority or Other||LSM Difference|0.35|Standard Error of the Mean|0.426||0.4123|2-Sided|80.0|-0.2|0.9||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Uncontrolled hostility/excitement symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639697|NCT01939548|3012645|Superiority or Other||LSM Difference|1.21|Standard Error of the Mean|0.895||0.1787|2-Sided|80.0|0.06|2.36||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639722|NCT01939197|3012690|Other||||||||||||||||||"The Fisher exact test was performed as prespecified on the SAP but the p-value couldn’t be calculated because SVR12 rates in both arms were 100%, hence p-value appeared as not available."
1639723|NCT01939197|3012691|Other|||||||1|||||||Fisher Exact||||
1639774|NCT01939002|3012712|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 12|
1639698|NCT01939548|3012645|Superiority or Other||LSM Difference|0.64|Standard Error of the Mean|0.888||0.4713|2-Sided|80.0|-0.5|1.78||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639699|NCT01939548|3012645|Superiority or Other||LSM Difference|0.69|Standard Error of the Mean|0.806||0.3963|2-Sided|80.0|-0.35|1.72||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639700|NCT01939548|3012645|Superiority or Other||LSM Difference|0.78|Standard Error of the Mean|0.789||0.3273|2-Sided|80.0|-0.24|1.79||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639701|NCT01939548|3012645|Superiority or Other||LSM Difference|-0.56|Standard Error of the Mean|0.593||0.3454|2-Sided|80.0|-1.33|0.2||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Disorganized thought symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639702|NCT01939548|3012645|Superiority or Other||LSM Difference|-0.1|Standard Error of the Mean|0.575||0.8601|2-Sided|80.0|-0.84|0.64||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Disorganized thought symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639703|NCT01939548|3012645|Superiority or Other||LSM Difference|1.05|Standard Error of the Mean|0.611||0.0869|2-Sided|80.0|0.27|1.84||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Anxiety/depression symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639704|NCT01939548|3012645|Superiority or Other||LSM Difference|0.96|Standard Error of the Mean|0.591||0.1083|2-Sided|80.0|0.19|1.72||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Anxiety/depression symptom score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639705|NCT01939548|3012646|Superiority or Other||LSM Difference|0.98|Standard Error of the Mean|1.326||0.4611|2-Sided|80.0|-0.73|2.69||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|General Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639706|NCT01939548|3012646|Superiority or Other||LSM Difference|1.63|Standard Error of the Mean|1.285||0.2068|2-Sided|80.0|-0.02|3.29||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|General Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639707|NCT01939548|3012646|Superiority or Other||LSM Difference|0.21|Standard Error of the Mean|0.761||0.7787|2-Sided|80.0|-0.77|1.19||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639708|NCT01939548|3012646|Superiority or Other||LSM Difference|0.39|Standard Error of the Mean|0.743||0.6015|2-Sided|80.0|-0.57|1.35||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Negative Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639772|NCT01939002|3012712|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 36|
1639907|NCT01934010|3013167|Superiority|||||||1|||||||Fisher Exact||||
1639709|NCT01939548|3012646|Superiority or Other||LSM Difference|0.85|Standard Error of the Mean|0.813||0.2961|2-Sided|80.0|-0.19|1.9||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639710|NCT01939548|3012646|Superiority or Other||LSM Difference|0.81|Standard Error of the Mean|0.809||0.3201|2-Sided|80.0|-0.23|1.85||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Positive Subscale Score comparison of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639711|NCT01939548|3012647|Superiority or Other||LSM Difference|-1.14|Standard Error of the Mean|1.502||0.4483|2-Sided|80.0|-3.08|0.79||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639712|NCT01939548|3012647|Superiority or Other||LSM Difference|-0.23|Standard Error of the Mean|1.476||0.8786|2-Sided|80.0|-2.13|1.67||Analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Analysis of change at Week 12. Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value by treatment interaction and background antipsychotics.|
1639713|NCT01939548|3012648|Superiority or Other||LSM Difference|2.3|Standard Error of the Mean|2.445||0.3488|2-Sided|80.0|-0.85|5.45||Primary analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), PANSS Total baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value of PANSS Total by treatment interaction and background antipsychotics.|
1639714|NCT01939548|3012648|Superiority or Other||Least Squares Mean (LSM) Difference|3.11|Standard Error of the Mean|2.409||0.1991|2-Sided|80.0|0.01|6.21||Primary analysis was two-sided and performed at the 0.2 significance level. No multiple comparisons adjustment was made.|Mixed Models Analysis||The estimation method used was restricted maximum likelihood.|Linear mixed-effect repeated measures model used. Fixed effects: treatment, time (visit), PANSS Total baseline value, investigator site; random effect: participant. Also included effects for treatment by time interaction and baseline value of PANSS Total by treatment interaction and background antipsychotics.|
1639715|NCT01939496|3012664|Superiority or Other||Difference of Least Square Means|-4.93|Standard Error of the Mean|1.75||0.006|2-Sided|95.0|-8.382|-1.469|||ANCOVA||||
1639716|NCT01939496|3012664|Superiority or Other||Difference of Least Square Means|-3.29|Standard Error of the Mean|1.748||0.062|2-Sided|95.0|-6.743|0.163|||ANCOVA||||
1639717|NCT01939366|3012669|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.01|Standard Error of the Mean|0.41||0.0153|2-Sided|95.0|-1.83|-0.2||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.|
1639718|NCT01939366|3012669|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.74|Standard Error of the Mean|0.39||0.0564|2-Sided|95.0|-1.5|0.02||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.|
1639719|NCT01939366|3012669|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.37||0.0621|2-Sided|95.0|-1.43|0.04||Due to the exploratory character of this trial, no multiple testing adjustment for control of the false positive rate was applied.|Mixed Models Analysis|The analysis consisted of the contrasts (mixed model Wald tests) of individual cebranopadol doses versus placebo during Week 6 of Maintenance Phase.||The mixed model repeated measurement (MMRM) model included fixed effects of pooled sites, treatment, week, treatment-by-week interaction, baseline pain, and a subject-specific random effect. The model was based on the weekly average 24-hour pain intensity of the 2 weeks in the Titration Phase and 6 weeks in the Maintenance Phase. An unstructured covariance matrix was used to model the covariance structure, denominator degrees of freedom were estimated using the Kenward-Roger approximation.|
1639720|NCT01939314|3012670|Superiority or Other||Risk Difference (RD)|24.7|||||2-Sided|95.0|2.6|43.6|||||||
1639721|NCT01939314|3012672|Superiority or Other||Risk Difference (RD)|7.5|||||2-Sided|95.0|-13.0|27.1|||||||
1639773|NCT01939002|3012712|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 24|
1639724|NCT01939197|3012692|Non-Inferiority|The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%).|||||||||||||||||"The historical SVR rate, as reported in the PHOTON-1 study, for sofosbuvir and RBV in HCV/HIV-1 coinfected adults is 76% (87/114) with a 95% confidence interval of (67%, 84%).~Reference: Sulkowski MS, Naggie S, Lalezari J, et al. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014;312(4):353-61."
1639725|NCT01939002|3012701|Superiority or Other|||||||0.1624|||||||2-sample t-test between 2 arms|||Change from 4WRI to L4W|
1639726|NCT01939002|3012701|Superiority or Other|||||||0.0031|||||||paired t-test within 1 arm|||Change from 4WRI to L4W|
1639727|NCT01939002|3012701|Superiority or Other|||||||0.223|||||||paired t-test within 1 arm|||Change from 4WRI to L4W|
1639728|NCT01939002|3012701|Superiority or Other|||||||0.0049|||||||paired t-test within 1 arm|||Change from 4WRI to L4W|
1639729|NCT01939002|3012703|Superiority or Other|||||||0.152||||||p-value on slope is based GLM with repeat measures over all visits.|general linear model||||
1639730|NCT01939002|3012703|Superiority or Other|||||||0.119|||||||paired t-test within 1 arm|||change at Early Termination|
1639731|NCT01939002|3012703|Superiority or Other|||||||0.0315|||||||paired t-test within 1 arm|||change at Week 48|
1639732|NCT01939002|3012703|Superiority or Other|||||||0.6508|||||||paired t-test within 1 arm|||change at Week 12|
1639733|NCT01939002|3012704|Superiority or Other|||||||0.3148||||||p-value on slope is based GLM with repeat measures over all visits.|general linear model||||
1639734|NCT01939002|3012704|Superiority or Other|||||||0.0824|||||||paired t-test within 1 arm|||change at Early Termination|
1639735|NCT01939002|3012704|Superiority or Other|||||||0.2547|||||||paired t-test within 1 arm|||change at Week 48|
1639736|NCT01939002|3012704|Superiority or Other|||||||0.1584|||||||paired t-test within 1 arm|||change at Week 36|
1639737|NCT01939002|3012704|Superiority or Other|||||||0.5298|||||||paired t-test within 1 arm|||change at Week 24|
1639738|NCT01939002|3012704|Superiority or Other|||||||0.4821|||||||paired t-test within 1 arm|||change at Week 12|
1639739|NCT01939002|3012705|Superiority or Other|||||||0.6402||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model||||
1639740|NCT01939002|3012705|Superiority or Other|||||||0.219|||||||paired t-test within 1 arm|||change at Week 48|
1639741|NCT01939002|3012705|Superiority or Other|||||||1|||||||paired t-test within 1 arm|||change at Week 36|
1639742|NCT01939002|3012705|Superiority or Other|||||||0.1092|||||||paired t-test within 1 arm|||change at Week 24|
1639743|NCT01939002|3012705|Superiority or Other|||||||0.2588|||||||paired t-test within 1 arm|||change at Week 12|
1639744|NCT01939002|3012706|Superiority or Other|||||||0.4182||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model||||
1639745|NCT01939002|3012706|Superiority or Other|||||||0.384|||||||paired t-test within 1 arm|||change at Early Termination|
1639746|NCT01939002|3012706|Superiority or Other|||||||0.5927|||||||paired t-test within 1 arm|||change at Week 48|
1639747|NCT01939002|3012706|Superiority or Other|||||||0.5106|||||||paired t-test within 1 arm|||change at Week 36|
1639748|NCT01939002|3012706|Superiority or Other|||||||0.1584|||||||paired t-test within 1 arm|||change at Week 24|
1639749|NCT01939002|3012706|Superiority or Other|||||||0.6569|||||||paired t-test within 1 arm|||change at Week 12|
1639750|NCT01939002|3012707|Superiority or Other|||||||0.1905|||||||2-sample t-test between 2 arms|||change at Week 4|
1639751|NCT01939002|3012707|Superiority or Other|||||||0.0464|||||||paired t-test within 1 arm|||change at Week 4|
1639752|NCT01939002|3012707|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4|
1639753|NCT01939002|3012708|Superiority or Other|||||||0.4973|||||||2-sample t-test between 2 arms|||change at Week 4|
1639754|NCT01939002|3012708|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4|
1639755|NCT01939002|3012708|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4|
1639756|NCT01939002|3012709|Superiority or Other|||||||0.0961|||||||2-sample t-test between 2 arms|||change at Week 4|
1639757|NCT01939002|3012709|Superiority or Other|||||||0.0792|||||||paired t-test within 1 arm|||change at Week 4|
1639758|NCT01939002|3012709|Superiority or Other|||||||0.0006|||||||paired t-test within 1 arm|||change at Week 4|
1639759|NCT01939002|3012710|Superiority or Other|||||||0.0782|||||||2-sample t-test between 2 arms|||change at Week 4|
1639760|NCT01939002|3012710|Superiority or Other|||||||0.0548|||||||paired t-test within 1 arm|||change at Week 4|
1639761|NCT01939002|3012710|Superiority or Other|||||||0.7012|||||||paired t-test within 1 arm|||change at Week 4|
1639762|NCT01939002|3012711|Superiority or Other||||||<|0.0001||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model||||
1639763|NCT01939002|3012711|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Early Termination|
1639764|NCT01939002|3012711|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 48|
1639765|NCT01939002|3012711|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 36|
1639766|NCT01939002|3012711|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 24|
1639767|NCT01939002|3012711|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 12|
1639768|NCT01939002|3012711|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4|
1639769|NCT01939002|3012712|Superiority or Other|||||||0.2248||||||p-value on slope is based on general linear model with repeat measures over all visits.|general linear model||||
1639770|NCT01939002|3012712|Superiority or Other|||||||0.1789|||||||paired t-test within 1 arm|||change at Early Termination|
1639771|NCT01939002|3012712|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 48|
1639775|NCT01939002|3012712|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm|||change at Week 4|
1639776|NCT01939002|3012713|Superiority or Other|||||||0.006|||||||paired t-test within 1 arm|||change at Early Termination|
1639777|NCT01939002|3012713|Superiority or Other|||||||0.4031|||||||paired t-test within 1 arm|||change at Week 48|
1639778|NCT01939002|3012713|Superiority or Other|||||||0.0197|||||||paired t-test within 1 arm|||change at Week 36|
1639779|NCT01939002|3012713|Superiority or Other|||||||0.0365|||||||paired t-test within 1 arm|||change at Week 24|
1639780|NCT01939002|3012713|Superiority or Other|||||||0.0007|||||||paired t-test within 1 arm|||change at Week 12|
1639781|NCT01939002|3012713|Superiority or Other|||||||0.0001|||||||paired t-test within 1 arm|||change at Week 4|
1639782|NCT01939002|3012714|Superiority or Other|||||||0.0171|||||||paired t-test within 1 arm|||change at Early Term|
1639783|NCT01939002|3012714|Superiority or Other|||||||0.2267|||||||paired t-test within 1 arm|||change at Week 48|
1639784|NCT01939002|3012714|Superiority or Other|||||||0.4173|||||||paired t-test within 1 arm|||change at Week 36|
1639785|NCT01939002|3012714|Superiority or Other|||||||0.8723|||||||paired t-test within 1 arm|||change at Week 24|
1639786|NCT01939002|3012714|Superiority or Other|||||||0.5834|||||||paired t-test within 1 arm|||change at Week 12|
1639787|NCT01939002|3012714|Superiority or Other|||||||0.2123|||||||paired t-test within 1 arm|||change at Week 4|
1639788|NCT01939002|3012715|Superiority or Other|||||||0.6422|||||||Fisher Exact|||Weeks 7-8|
1639789|NCT01939002|3012715|Superiority or Other|||||||0.5008|||||||Fisher Exact|||Weeks 5-6|
1639790|NCT01939002|3012715|Superiority or Other|||||||0.732|||||||Fisher Exact|||Weeks 3-4|
1639791|NCT01939002|3012715|Superiority or Other|||||||0.0767|||||||Fisher Exact|||Weeks 0-2|
1639792|NCT01939002|3012715|Superiority or Other|||||||0.0834|||||||Fisher Exact|||first 8 weeks|
1639793|NCT01939002|3012716|Superiority or Other|||||||0.4861|||||||2-sample t-test between 2 arms||||
1639794|NCT01939002|3012716|Superiority or Other|||||||0.0391|||||||paired t-test within 1 arm||||
1639795|NCT01939002|3012716|Superiority or Other|||||||0.3377|||||||paired t-test within 1 arm||||
1639796|NCT01939002|3012716|Superiority or Other|||||||0.0545|||||||paired t-test within 1 arm||||
1639797|NCT01939002|3012717|Superiority or Other|||||||0.7497|||||||2-sample t-test between 2 arms||||
1639798|NCT01939002|3012717|Superiority or Other|||||||0.0002|||||||paired t-test within 1 arm||||
1639799|NCT01939002|3012717|Superiority or Other|||||||0.0075|||||||paired t-test within 1 arm||||
1639800|NCT01939002|3012717|Superiority or Other|||||||0.009|||||||paired t-test within 1 arm||||
1639801|NCT01939002|3012718|Superiority or Other|||||||0.4234|||||||2-sample t-test between 2 arms||||
1639802|NCT01939002|3012718|Superiority or Other|||||||0.2186|||||||paired t-test within 1 arm||||
1639803|NCT01939002|3012718|Superiority or Other|||||||0.7805|||||||paired t-test within 1 arm||||
1639804|NCT01939002|3012718|Superiority or Other|||||||0.1407|||||||paired t-test within 1 arm||||
1639805|NCT01939002|3012719|Superiority or Other|||||||0.838|||||||2-sample t-test between 2 arms||||
1639806|NCT01939002|3012719|Superiority or Other|||||||0.0027|||||||paired t-test within 1 arm||||
1639807|NCT01939002|3012719|Superiority or Other|||||||0.0789|||||||paired t-test within 1 arm||||
1639808|NCT01939002|3012719|Superiority or Other|||||||0.0105|||||||paired t-test within 1 arm||||
1639809|NCT01939002|3012720|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm||||
1639810|NCT01939002|3012720|Superiority or Other||||||<|0.0009|||||||paired t-test within 1 arm||||
1639811|NCT01939002|3012720|Superiority or Other||||||<|0.0019|||||||paired t-test within 1 arm||||
1639812|NCT01939002|3012721|Superiority or Other|||||||0.3792|||||||2-sample t-test between 2 arms||||
1639813|NCT01939002|3012721|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm||||
1639814|NCT01939002|3012721|Superiority or Other||||||<|0.0001|||||||paired t-test within 1 arm||||
1639815|NCT01939002|3012721|Superiority or Other||||||<|0.0009|||||||paired t-test within 1 arm||||
1639816|NCT01939002|3012722|Superiority or Other|||||||0.1771|||||||2-sample t-test between 2 arms||||
1639817|NCT01939002|3012722|Superiority or Other|||||||0.8484|||||||paired t-test within 1 arm||||
1639818|NCT01939002|3012722|Superiority or Other|||||||0.3582|||||||paired t-test within 1 arm||||
1639819|NCT01939002|3012722|Superiority or Other|||||||0.3189|||||||paired t-test within 1 arm||||
1639820|NCT01939002|3012723|Superiority or Other|||||||0.1631|||||||2-sample t-test between 2 arms||||
1639821|NCT01939002|3012723|Superiority or Other|||||||0.2533|||||||paired t-test within 1 arm||||
1639822|NCT01939002|3012723|Superiority or Other|||||||0.8246|||||||paired t-test within 1 arm||||
1639823|NCT01939002|3012723|Superiority or Other|||||||0.0945|||||||paired t-test within 1 arm||||
1639824|NCT01939002|3012724|Superiority or Other|||||||0.5488|||||||McNemar||||
1639825|NCT01939002|3012724|Superiority or Other|||||||0.0654|||||||McNemar||||
1639826|NCT01939002|3012724|Superiority or Other|||||||0.0525|||||||McNemar||||
1639827|NCT01939002|3012725|Superiority or Other|||||||0.5811|||||||McNemar||||
1639828|NCT01939002|3012725|Superiority or Other|||||||0.5078|||||||McNemar||||
1639829|NCT01939002|3012725|Superiority or Other|||||||1|||||||McNemar|McNemar tests the null hypothesis of no difference in FLS between 4WRI and F8W.|||
1639830|NCT01939002|3012727|Superiority or Other|||||||0.2037||||||Chi-square test between 2 treatment arms.|Chi-squared||||
1639831|NCT01939002|3012728|Superiority or Other||||||<|0.0001||||||1-sample Chi-square test comparing to Null hypotheses at 25%.|Chi-squared||||
1639832|NCT01938040|3012823|Superiority or Other|||||||0.001|||||||ANOVA||||
1639833|NCT01938001|3012832|Superiority||Hazard Ratio (HR)|0.54||||0.0007|2-Sided|95.0|0.38|0.78|||Stratified Log Rank Test|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).|||
1639834|NCT01938001|3012833|Superiority||Hazard Ratio (HR)|0.51|||<|0.0001|2-Sided|95.0|0.38|0.67|||Stratified Log-Rank Test|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).|Hazard ratio and its CI were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.||
1639835|NCT01938001|3012834|Superiority||Hazard Ratio (HR)|0.68||||0.2993|2-Sided|95.0|0.32|1.43|||Log Rank||||
1639836|NCT01938001|3012835|Superiority||Hazard Ratio (HR)|0.53||||0.0015|2-Sided|95.0|0.36|0.79|||Log Rank||||
1639837|NCT01938001|3012836|Superiority||||||=|0|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).|||
1639838|NCT01938001|3012837|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).|||
1639839|NCT01938001|3012838|Superiority||Hazard Ratio (HR)|0.61|||||2-Sided|95.0|0.33|1.13||||||Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).|
1639840|NCT01938001|3012839|Superiority|||||||0.0006|||||||Cochran-Mantel-Haenszel|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).|||
1639841|NCT01938001|3012840|Superiority||Hazard Ratio (HR)|0.46|||<|0.0001|2-Sided|95.0|0.34|0.62|||Log Rank|Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, > 2 years), and disease histology (FL, MZL).|Hazard ratio and its confidence interval (CI) were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.||
1639842|NCT01937975|3012841|Superiority or Other||Geometric Mean Ratio|0.63|||||2-Sided|90.0|0.45|0.89|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10||
1639843|NCT01937975|3012841|Superiority or Other||Geometric Mean Ratio|0.95|||||2-Sided|90.0|0.7|1.3|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10||
1639844|NCT01937975|3012842|Superiority or Other||Geometric Mean Ratio|0.54|||||2-Sided|90.0|0.4|0.72|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10|
1639845|NCT01937975|3012842|Superiority or Other||Geometric Mean Ratio|1.01|||||2-Sided|90.0|0.77|1.34|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10|
1639846|NCT01937975|3012842|Superiority or Other||Geometric Mean Ratio|1.16|||||2-Sided|90.0|0.88|1.53|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10|
1639847|NCT01937975|3012842|Superiority or Other||Geometric Mean Ratio|0.88|||||2-Sided|90.0|0.83|0.92|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10|
1639848|NCT01937975|3012845|Superiority or Other||Geometric Mean Ratio|1.66|||||2-Sided|90.0|1.21|2.28|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10|
1639849|NCT01937975|3012845|Superiority or Other||Geometric Mean Ratio|0.94|||||2-Sided|90.0|0.7|1.27|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10|
1639850|NCT01937975|3012845|Superiority or Other||Geometric Mean Ratio|0.84|||||2-Sided|90.0|0.62|1.13|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10|
1639851|NCT01937975|3012845|Superiority or Other||Geometric Mean Ratio|1.12|||||2-Sided|90.0|1.0|1.26|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10|
1639852|NCT01937975|3012846|Superiority or Other||Geometric Mean Ratio|2.07|||||2-Sided|90.0|1.46|2.93|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10|
1639853|NCT01937975|3012846|Superiority or Other||Geometric Mean Ratio|0.95|||||2-Sided|90.0|0.69|1.32|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10|
1639854|NCT01937975|3012846|Superiority or Other||Geometric Mean Ratio|0.77|||||2-Sided|90.0|0.56|1.06|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10|
1639855|NCT01937975|3012846|Superiority or Other||Geometric Mean Ratio|1.24|||||2-Sided|90.0|1.17|1.32|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10|
1639856|NCT01937975|3012847|Superiority or Other||Geometric Mean Ratio|1.86|||||2-Sided|90.0|1.38|2.51|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10|
1639857|NCT01937975|3012847|Superiority or Other||Geometric Mean Ratio|0.99|||||2-Sided|90.0|0.75|1.3|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10|
1639858|NCT01937975|3012847|Superiority or Other||Geometric Mean Ratio|0.86|||||2-Sided|90.0|0.65|1.14|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10|
1639859|NCT01937975|3012847|Superiority or Other||Geometric Mean Ratio|1.14|||||2-Sided|90.0|1.08|1.21|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10|
1639860|NCT01937975|3012848|Superiority or Other||Geometric Mean Ratio|0.61|||||2-Sided|90.0|0.39|0.94|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10||
1639861|NCT01937975|3012848|Superiority or Other||Geometric Mean Ratio|0.94|||||2-Sided|90.0|0.63|1.42|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10||
1639862|NCT01937975|3012849|Superiority or Other||Geometric Mean Ratio|0.61|||||2-Sided|90.0|0.4|0.92|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10|
1639863|NCT01937975|3012849|Superiority or Other||Geometric Mean Ratio|1.21|||||2-Sided|90.0|0.82|1.78|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10|
1639864|NCT01937975|3012849|Superiority or Other||Geometric Mean Ratio|1.18|||||2-Sided|90.0|0.8|1.73|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10|
1639865|NCT01937975|3012849|Superiority or Other||Geometric Mean Ratio|1.03|||||2-Sided|90.0|0.92|1.15|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10|
1639908|NCT01934010|3013168|Superiority|||||||0.1001|||||||Fisher Exact||||
1639866|NCT01937975|3012852|Superiority or Other||Geometric Mean Ratio|1.66|||||2-Sided|90.0|0.99|2.77|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10|
1639867|NCT01937975|3012852|Superiority or Other||Geometric Mean Ratio|0.88|||||2-Sided|90.0|0.54|1.42|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10|
1639868|NCT01937975|3012852|Superiority or Other||Geometric Mean Ratio|0.92|||||2-Sided|90.0|0.57|1.48|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10|
1639869|NCT01937975|3012852|Superiority or Other||Geometric Mean Ratio|0.96|||||2-Sided|90.0|0.75|1.22|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10|
1639870|NCT01937975|3012853|Superiority or Other||Geometric Mean Ratio|1.6|||||2-Sided|90.0|1.06|2.42|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10|
1639871|NCT01937975|3012853|Superiority or Other||Geometric Mean Ratio|0.78|||||2-Sided|90.0|0.53|1.14|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10|
1639872|NCT01937975|3012853|Superiority or Other||Geometric Mean Ratio|0.79|||||2-Sided|90.0|0.54|1.16|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10|
1639873|NCT01937975|3012853|Superiority or Other||Geometric Mean Ratio|0.98|||||2-Sided|90.0|0.81|1.19|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10|
1639874|NCT01937975|3012854|Superiority or Other||Geometric Mean Ratio|1.65|||||2-Sided|90.0|1.09|2.49|||||Geometric Mean Ratio = SRI Day 10 / Healthy Day 10|SRI Participants Day 10 versus Healthy Participants Day 10|
1639875|NCT01937975|3012854|Superiority or Other||Geometric Mean Ratio|0.83|||||2-Sided|90.0|0.56|1.22|||||Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10|ESRD HD Day 10 versus Healthy Participants Day 10|
1639876|NCT01937975|3012854|Superiority or Other||Geometric Mean Ratio|0.85|||||2-Sided|90.0|0.58|1.25|||||Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10|ESRD Non-HD Day 9 versus Healthy Participants Day 10|
1639877|NCT01937975|3012854|Superiority or Other||Geometric Mean Ratio|0.97|||||2-Sided|90.0|0.87|1.09|||||Geometric Mean Ratio = ESRD HD Day 10 / ESRD Non-HD Day 9|ESRD Non-HD Day 9 versus ESRD HD Day 10|
1639878|NCT01937871|3012872|Superiority or Other||Mean Difference (Final Values)|-0.85|||||2-Sided|95.0|-1.87|0.18|||||||
1639879|NCT01937871|3012876|Superiority or Other||Mean Difference (Final Values)|-1.41|||||2-Sided|95.0|-2.25|-0.57|||||||
1639880|NCT01937364|3012942|Superiority or Other|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Baclofen - Placebo; Total Ativan 1mg PO equivalent dose|
1639881|NCT01937364|3012942|Superiority or Other|||||||0.33||||||Baclofen - Placebo; Peak Ativan 1mg PO equivalent dose|Wilcoxon (Mann-Whitney)||||
1639882|NCT01937364|3012943|Superiority or Other|||||||0.1393|||||||Mixed Models Analysis|||Baclofen - Placebo; 72 hours|
1639883|NCT01937364|3012943|Superiority or Other|||||||0.7616|||||||Mixed Models Analysis|||Baclofen - Placebo; 48 hours|
1639884|NCT01937364|3012943|Superiority or Other|||||||0.3744|||||||Mixed Models Analysis|||Baclofen - Placebo; 24 hours|
1639885|NCT01937364|3012944|Superiority or Other||Risk Difference (RD)|-0.4||||0.0334|2-Sided|90.0|-0.7275|-0.0206||One-sided p-value|z-statistic with pooled estimate||RD = Baclofen - Placebo||
1639886|NCT01936909|3012984|Superiority|Log-rank test||||||0.12|||||||Log Rank||||
1639887|NCT01936909|3012985|Superiority||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Paired analysis versus baseline|
1639888|NCT01936909|3012986|Superiority||||||>|0.2|||||||ANOVA|||This test reflects a comparison between baseline and 2 weeks (both rows).|
1639889|NCT01936467|3013011|Superiority or Other|||||||0.46|||||||Chi-squared||||
1639890|NCT01936467|3013012|Superiority or Other|||||||0.15|||||||Chi-squared||||
1639891|NCT01936467|3013013|Superiority or Other|||||||0.71|||||||Chi-squared||||
1639892|NCT01936467|3013014|Other|||||||0.47|||||||Chi-squared||||
1639893|NCT01936467|3013015|Other||Specificity|100.0|||||2-Sided||||||||||
1639894|NCT01936467|3013015|Other||Sensitivity|88.6|||||2-Sided||||||||||
1639895|NCT01936467|3013016|Other||Specificity|100.0|||||2-Sided||||||||||
1639896|NCT01936467|3013016|Other||Sensitivity|93.7|||||2-Sided||||||||||
1639897|NCT01936324|3013030|Other|||||||0.007|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by study center|||
1639898|NCT01936324|3013031|Other|||||||0.0032|||||||ANCOVA|ANCOVA model with terms of treatment, baseline lesion count, and center|||
1639899|NCT01936324|3013032|Other|||||||0.0003|||||||ANCOVA|ANCOVA model with terms of treatment, baseline lesion count, and center.|||
1639900|NCT01934231|3013105|Superiority or Other||Rate of Cure|88.5|||||2-Sided|95.0|69.85|97.55|||||"The estimated parameter represents the rate of cure, calculated as (number of participants with an outcome of Cure/number of participants analyzed) * 100."||
1639901|NCT01934218|3013106|Other|Euflexxa would be considered superior to Gel-One if the difference in mean change from baseline in VAS pain score at week 26 was 5 mm or greater (on the 100mm VAS pain scale). If the difference in mean change values were within 5 mm, Gel-One would not be considered inferior to Euflexxa.||||||||||||||||A post-hoc non-inferiority comparison of the Gel-One mean change from baseline in VAS pain score at week 26 (Following 50-foot walk test) against the same assessment collected from subjects treated with Euflexxa in a separate study (PMID:19539353) was also performed.|Change from baseline (95% CI) for Euflexxa was -25.7 (-29.0, -22.4) and the difference between Euflexxa and Gel-One (95% CI) was -3.8 (-inf, -0.3).
1639902|NCT01934218|3013107|Superiority||Mean Difference (Final Values)|0.0||||0.988|2-Sided|95.0|-2.7|2.7|||Basic longitudinal model||||
1639903|NCT01934192|3013141|Superiority or Other||Mean Difference (Final Values)|6.5|Standard Error of the Mean|6.74|||2-Sided|95.0|-6.9|19.9|||||||
1639904|NCT01934192|3013142|Superiority or Other||Mean Difference (Final Values)|8.9|Standard Error of the Mean|7.03|||2-Sided|95.0|-5.1|22.9|||||||
1639905|NCT01934192|3013143|Superiority or Other||Mean Difference (Final Values)|2.2|Standard Error of the Mean|4.35|||2-Sided|95.0|-6.5|10.9|||||||
1639906|NCT01934192|3013144|Superiority or Other||Mean Difference (Final Values)|8.9|Standard Error of the Mean|7.02|||2-Sided|95.0|-5.1|22.9|||||||
1639912|NCT01934010|3013171|Superiority|||||||1|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 2 treatment cycles with AM-101 or others who received 3 treatment cycles.|
1639913|NCT01934010|3013171|Superiority|||||||0.075|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 1 treatment cycle with AM-101 or others who received 3 treatment cycles.|
1639914|NCT01934010|3013171|Superiority|||||||0.128|||||||Fisher Exact|||Fisher's exact test to assess if there is a difference in deterioration of hearing threshold between subjects that received 1 treatment cycle with AM-101 or others who received 2 treatment cycles.|
1639915|NCT01933932|3013180|Superiority or Other (legacy)||Hazard Ratio (HR)|0.9||||0.3438|2-Sided|95.0|0.74|1.11|||Log Rank|Analysis stratified by WHO performance status at randomisation.|||
1639916|NCT01933932|3013181|Superiority or Other (legacy)||Odds Ratio (OR)|1.17||||0.5007|2-Sided|95.0|0.74|1.86|||Regression, Logistic|Analysis stratified by WHO performance status at randomisation|||
1639917|NCT01933932|3013183|Superiority or Other (legacy)||Odds Ratio (OR)|1.61||||0.0515|2-Sided|95.0|1.0|2.62|||Regression, Logistic|Analysis stratified by WHO performance status at randomisation|||
1639918|NCT01933932|3013184|Superiority or Other (legacy)||Hazard Ratio (HR)|1.05||||0.6431|2-Sided|95.0|0.85|1.3|||Log Rank|Analysis stratified by WHO performance status at randomisation.|||
1639919|NCT01933932|3013185|Superiority or Other (legacy)||Hazard Ratio (HR)|0.93||||0.4355|2-Sided|95.0|0.77|1.12|||Log Rank|Analysis stratified by WHO performance status at randomisation.|||
1639920|NCT01933919|3013197|Superiority||LS Mean Difference (Fluvoxamine-Placebo)|-4.3|Standard Error of the Mean|2.07||0.044|2-Sided|95.0|-8.5|-0.1|||ANCOVA|ANCOVA with baseline JCY-BOCS (10-item) total score and age as covariates and treatment as fixed effect.|The model included the fixed effects of treatment, with baseline JCY-BOCS (10-item) total score and age as covariates.||
1639921|NCT01933880|3013221|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 12 for the OROS-MPH group|
1639922|NCT01933880|3013222|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 7 for the OROS-MPH group|
1639923|NCT01933880|3013223|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 3 for the OROS-MPH group|
1639924|NCT01933880|3013224|Superiority or Other|||||||0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 2 for the OROS-MPH group|
1639925|NCT01933880|3013225|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||P-value was calculated to compare the data at Baseline and change at Week 1 for the OROS-MPH group|
1639926|NCT01933880|3013226|Superiority or Other|||||||0.0387|||||||Signed Rank Sum Test|||P-value was calculated to compare the data at Baseline and change at Week 12 for the OROS-MPH group|
1639927|NCT01933789|3013227|Superiority||probit regression coefficient|-0.287||||0.303|2-Sided|95.0|-1.005|0.431||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.||
1639928|NCT01933789|3013228|Superiority||probit regression coefficient|-0.01||||0.955|2-Sided|95.0|-0.474|0.454||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.||
1639929|NCT01933789|3013229|Superiority||probit regression coefficient|-0.229||||0.47|2-Sided|95.0|-1.044|0.587||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.||
1639930|NCT01933789|3013230|Superiority||probit regression coefficient|-0.014||||0.94|2-Sided|95.0|-0.489|0.461||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.||
1639931|NCT01933789|3013231|Superiority||probit regression coefficient|-0.39||||0.192|2-Sided|95.0|-1.16|0.38||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.||
1639932|NCT01933789|3013232|Superiority||probit regression coefficient|-0.13||||0.501|2-Sided|95.0|-0.63|0.369||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.||
1639933|NCT01933789|3013233|Superiority||probit regression coefficient|-0.293||||0.372|2-Sided|95.0|-1.139|0.553||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.||
1639934|NCT01933789|3013234|Superiority||probit regression coefficient|-0.121||||0.552|2-Sided|95.0|-0.646|0.403||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.||
1639935|NCT01933789|3013235|Superiority||probit regression coefficient|-0.165||||0.908|2-Sided|95.0|-3.833|3.503||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|Adjusted for confounding by patient education and health status and by clinician gender.|Control group coded 0; intervention group coded 1.||
1639936|NCT01933789|3013236|Superiority||probit regression coefficient|0.123||||0.644|2-Sided|95.0|-0.56|0.805||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.||
1639937|NCT01933789|3013237|Superiority||probit regression coefficient|-0.179||||0.705|2-Sided|95.0|-1.398|1.04||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.||
1639938|NCT01933789|3013240|Superiority||probit regression coefficient|0.14||||0.592|2-Sided|95.0|-0.534|0.815||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment|Control group coded 0; intervention group coded 1.||
1639939|NCT01933789|3013241|Superiority||probit regression coefficient|0.175||||0.568|2-Sided|95.0|-0.613|0.962||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|No covariate adjustment.|Control group coded 0; intervention group coded 1.||
1639940|NCT01933789|3013242|Superiority||probit regression coefficient|-0.221||||0.418|2-Sided|95.0|-0.923|0.482||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians."|clustered probit regression|Adjusted for confounding by patient race and health status and by clinician type and specialty|Control group coded 0; intervention group coded 1.||
1639941|NCT01933789|3013243|Superiority||Tobit regression coefficient|-0.105||||0.852|2-Sided|95.0|-1.204|0.995||"No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.~Patients clustered under clinicians. Clustered Tobit regression because of strong floor effect on composite score."|Clustered Tobit regression|Adjusted for baseline level of the GAD-7 composite score.|Control group coded 0; intervention group coded 1.||
1639942|NCT01933789|3013244|Superiority||Probit regression coefficient|-0.042||||0.689|2-Sided|95.0|-0.247|0.163||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent anxiety variable.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over time|
1639943|NCT01933789|3013245|Superiority||Tobit regression coefficient|0.041||||0.935|2-Sided|95.0|-0.946|1.028||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Pts clustered under clins. Clustered Tobit regression because strong floor effect on composite score. Adjusted for baseline level of composite score.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Standard GAD-7 composite score|
1639944|NCT01933789|3013246|Superiority||Probit regression coefficient|-0.034||||0.734|2-Sided|95.0|-0.232|0.163||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent anxiety variable.|Control group coded 0; intervention group coded 1.|Symptoms of anxiety: Two-indicator latent variable with measurement invariance imposed between groups and over time|
1639945|NCT01933789|3013247|Superiority||Probit regression coefficient|0.446||||0.343|2-Sided|95.0|-0.476|1.368||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered robust linear regression|Patients clustered under clinicians. Adjusted for baseline level of the PHQ-8 composite score and clinician specialty.|Control group coded 0; intervention group coded 1.|Symptoms of depression: Standard PHQ-8 composite score|
1639946|NCT01933789|3013248|Superiority||Probit regression coefficient|0.208||||0.106|2-Sided|95.0|-0.044|0.461||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Pts clustered under clins. Adjusted for baseline level of the latent depression var; pt age, minority status, education, health status; clin specialty|Control group coded 0; intervention group coded 1.|Symptoms of depression: Two-indicator latent variable with measurement invariance imposed between groups and over time|
1639947|NCT01933789|3013249|Superiority||Probit regression coefficient|0.263||||0.536|2-Sided|95.0|-0.571|1.097||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered robust linear regression|Patients clustered under clinicians. Adjusted for baseline level of the PHQ-8 composite score.|Control group coded 0; intervention group coded 1.|Symptoms of depression: standard PHQ-8 composite score.|
1639948|NCT01933789|3013250|Superiority||Probit regression coefficient|-0.103||||0.369|2-Sided|95.0|-0.327|0.122||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for baseline level of the latent depression variable and for the patient racial/ethnic minority status.|Control group coded 0; intervention group coded 1.|Symptoms of depression - Two-indicator latent variable with measurement invariance imposed between groups and over time.|
1639949|NCT01933789|3013251|Superiority||Tobit regression coefficient|2.455||||0.075|2-Sided|95.0|-0.25|5.159||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline and clinician type.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician’s quality of communication about patient’s religious/spiritual beliefs.~Variable with range 0-11, defined as censored from below because of strong floor effect."|
1639950|NCT01933789|3013251|Superiority||Tobit regression coefficient|2.404||||0.002|2-Sided|95.0|0.898|3.909||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician’s quality of communication about things in life that are important to the patient.~Variable with range 0-11, defined as censored from below because of strong floor effect."|
1639951|NCT01933789|3013251|Superiority||Tobit regression coefficient|4.625|||<|0.001|2-Sided|95.0|2.06|7.19||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician’s quality of communication about patient’s involvement in end-of-life treatment decisions.~Variable with range 0-11, defined as censored from below because of strong floor effect."|
1639952|NCT01933789|3013251|Superiority||Tobit regression coefficient|1.573|||<|0.352|2-Sided|95.0|-1.742|4.887||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Pts clustered under clins. Adjusted for outcome variable as measured at baseline: pt. minority status, education, income; clinician type & specialty.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician’s quality of communication about what dying might be like.~Variable with range 0-11, defined as censored from below because of strong floor effect."|
1639976|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|1.69|||||2-Sided|80.0|-0.5|3.88||||||Compared with Baseline (Pre-lunch)|
1639953|NCT01933789|3013251|Superiority||Tobit regression coefficient|2.329|||<|0.098|2-Sided|95.0|-0.426|5.083||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline and clinician specialty.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician’s quality of communication about how long the patient might have to live.~Variable with range 0-11, defined as censored from below because of strong floor effect."|
1639954|NCT01933789|3013251|Superiority||Tobit regression coefficient|1.237|||<|0.122|2-Sided|95.0|-0.33|2.804||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician’s quality of communication about details of getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect."|
1639955|NCT01933789|3013251|Superiority||Tobit regression coefficient|2.209|||<|0.001|2-Sided|95.0|0.939|3.479||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered Tobit regression|Patients clustered under clinicians. Adjusted for the outcome variable as measured at baseline.|Control group coded 0; intervention group coded 1.|"Patient rating of clinician’s quality of communication about patient’s feelings about getting sicker.~Variable with range 0-11, defined as censored from below because of strong floor effect."|
1639956|NCT01933789|3013252|Superiority||Probit regression coefficient|2.022||||0.01|2-Sided|95.0|0.476|3.569||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the latent variable as measured at baseline.|Control group coded 0; intervention group coded 1.||
1639957|NCT01933789|3013253|Superiority||Probit regression coefficient|0.481||||0.017|2-Sided|95.0|0.085|0.877||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the patient’s treatment preference (focus on life extension vs. comfort care).|Control group coded 0; intervention group coded 1.||
1639958|NCT01933789|3013254|Superiority||Probit regression coefficient|0.334||||0.073|2-Sided|95.0|-0.031|0.699||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Adjusted for the patient’s treatment preference (focus on life extension vs. comfort care).|Control group coded 0; intervention group coded 1.|Occurrence of goal-concordant care|
1639959|NCT01933789|3013256|Superiority||Probit regression coefficient|1.381|||<|0.001|2-Sided|95.0|1.046|1.715||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.||
1639960|NCT01933789|3013257|Superiority||Probit regression coefficient|1.251|||<|0.001|2-Sided|95.0|0.92|1.583||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.||
1639961|NCT01933789|3013258|Superiority||Probit regression coefficient|1.145|||<|0.001|2-Sided|95.0|0.844|1.446||No adjustment for multiple tests. A priori threshold of 0.05 for statistical significance.|Clustered probit regression|Patients clustered under clinicians. Bivariate model; there were no confounders.|Control group coded 0; intervention group coded 1.||
1639962|NCT01933672|3013269|Superiority or Other||Mean Difference (Final Values)|0.51|||||2-Sided|80.0|-0.45|1.47|||||||
1639963|NCT01933672|3013269|Superiority or Other||Mean Difference (Final Values)|1.06|||||2-Sided|80.0|0.17|1.95|||||||
1639964|NCT01933672|3013269|Superiority or Other||Mean Difference (Final Values)|-0.26|||||2-Sided|80.0|-0.92|0.4||||||Compared with baseline|
1639965|NCT01933672|3013269|Superiority or Other||Mean Difference (Final Values)|0.25|||||2-Sided|80.0|-0.43|0.93||||||Compared with baseline|
1639966|NCT01933672|3013269|Superiority or Other||Mean Difference (Final Values)|0.8|||||2-Sided|80.0|0.21|1.39||||||Compared with baseline|
1639967|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|1.64|||||2-Sided|80.0|-2.6|5.89||||||Pre-dinner; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.|
1639968|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|-4.12|||||2-Sided|80.0|-8.42|0.18||||||Pre-dinner; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.|
1639969|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|3.42|||||2-Sided|80.0|-0.1|6.94||||||Compared with Baseline (Pre-dinner)|
1639970|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|5.06|||||2-Sided|80.0|1.7|8.43||||||Compared with Baseline (Pre-dinner)|
1639971|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|-0.7|||||2-Sided|80.0|-3.66|2.27||||||Compared with Baseline (Pre-dinner)|
1639972|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|4.08|||||2-Sided|80.0|0.54|7.62||||||Pre-lunch; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.|
1639973|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|1.7|||||2-Sided|80.0|-1.62|5.01||||||Pre-lunch; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.|
1639974|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|-0.01|||||2-Sided|80.0|-2.42|2.4||||||Compared with Baseline (Pre-lunch)|
1639975|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|4.07|||||2-Sided|80.0|1.56|6.58||||||Compared with Baseline (Pre-lunch)|
1640054|NCT01933594|3013291|Superiority|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion|
1639977|NCT01933672|3013272|Superiority or Other||Median Difference (Final Values)|-1.14|||||2-Sided|80.0|-2.63|0.35||||||Pre-breakfast; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.|
1639978|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|-1.45|||||2-Sided|80.0|-2.84|-0.05||||||Pre-breakfast; Time-matched change from baseline in pre-meal insulin on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.|
1639979|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|1.6|||||2-Sided|80.0|0.58|2.63||||||Compared with Baseline (Pre-breakfast)|
1639980|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|0.46|||||2-Sided|80.0|-0.58|1.51||||||Compared with Baseline (Pre-breakfast)|
1639981|NCT01933672|3013272|Superiority or Other||Mean Difference (Final Values)|0.16|||||2-Sided|80.0|-0.75|1.07||||||Compared with Baseline （Pre-breakfast）|
1639982|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|-0.02|||||2-Sided|80.0|-0.55|0.51||||||Pre-dinner; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.|
1639983|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|0.04|||||2-Sided|80.0|-0.45|0.53||||||Pre-dinner; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.|
1639984|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|0.32|||||2-Sided|80.0|-0.05|0.68||||||Compared with Baseline (Pre-dinner)|
1639985|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|0.3|||||2-Sided|80.0|-0.08|0.67||||||Compared with Baseline (Pre-dinner)|
1639986|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|0.36|||||2-Sided|80.0|0.03|0.68||||||Compared with Baseline (Pre-dinner)|
1639987|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|0.65|||||2-Sided|80.0|0.19|1.11||||||Pre-lunch; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.|
1639988|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|0.14||||||80.0|-0.28|0.57||||||Pre-lunch; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.|
1639989|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|0.06|||||2-Sided|80.0|-0.26|0.37||||||Compared with Baseline (Pre-lunch)|
1639990|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|0.7|||||2-Sided|80.0|0.38|1.03||||||Compared with Baseline (Pre-lunch)|
1639991|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|0.2|||||2-Sided|80.0|-0.08|0.48||||||Compared with Baseline (Pre-lunch)|
1639992|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|-0.24|||||2-Sided|80.0|-0.45|-0.03||||||Pre-breakfast; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.|
1639993|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|-0.36|||||2-Sided|80.0|-0.56|-0.36||||||Pre-breakfast; Time-matched change from baseline in pre-meal C-peptide on Day 14 was analyzed using a mixed effects model with sequence, period, treatment, the treatment by-time interaction, period-specific baseline and carryover as fixed effects. Subjects within sequences were modeled as random effects.|
1639994|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|0.3|||||2-Sided|80.0|0.16|0.45||||||Compared with Baseline (Pre-breakfast)|
1639995|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|0.06|||||2-Sided|80.0|-0.09|0.21||||||Compared with Baseline (Pre-breakfast)|
1639996|NCT01933672|3013273|Superiority or Other||Mean Difference (Final Values)|-0.06|||||2-Sided|80.0|-0.19|0.07||||||Compared with Baseline （Pre-breakfast）|
1639997|NCT01933672|3013274|Superiority or Other||Mean Difference (Final Values)|-4.19|||||2-Sided|80.0|-10.86|2.49||||||Change from baseline in FPG was analyzed in a mixed model analysis of covariance (ANCOVA) with regimen, period, sequence, treatment × period, and carryover as fixed effects. Subjects within sequences were modelled as random effects, with each subject’s period-specific baseline response included, as fixed covariates.|
1639998|NCT01933672|3013274|Superiority or Other||Median Difference (Final Values)|-5.41|||||2-Sided|80.0|-11.74|0.92||||||Change from baseline in FPG was analyzed in a mixed model analysis of covariance (ANCOVA) with regimen, period, sequence, treatment × period, and carryover as fixed effects. Subjects within sequences were modelled as random effects, with each subject’s period-specific baseline response included, as fixed covariates.|
1639999|NCT01933672|3013274|Superiority or Other||Mean Difference (Final Values)|-16.51|||||2-Sided|80.0|-22.24|-10.78||||||Compared with Baseline|
1640000|NCT01933672|3013274|Superiority or Other||Mean Difference (Final Values)|-20.7|||||2-Sided|80.0|-26.3|-15.1||||||Compared with Baseline|
1640001|NCT01933672|3013274|Superiority or Other||Mean Difference (Final Values)|-21.92|||||2-Sided|80.0|-27.0|-16.85||||||Compared with Baseline|
1640002|NCT01933672|3013275|Superiority or Other||Mean Difference (Final Values)|-12.09|||||2-Sided|80.0|-19.81|-4.17||||||There was no hypothesis to be tested. Difference in change from baseline in WMDG between the 2 treatment groups was calculated based on the mixed effects repeated measures model.|
1640003|NCT01933672|3013275|Superiority or Other||Mean Difference (Final Values)|-11.99|||||2-Sided|80.0|-19.81|-4.17||||||There was no hypothesis to be tested. Difference in change from baseline in WMDG between the 2 treatment groups was calculated based on the mixed effects repeated measures model.|
1640004|NCT01933672|3013275|Superiority or Other||Mean Difference (Final Values)|-19.24|||||2-Sided|80.0|-24.99|-13.5||||||Change from baseline|
1640005|NCT01933672|3013275|Superiority or Other||Median Difference (Final Values)|-31.33|||||2-Sided|80.0|-37.29|-25.37||||||Change from baseline|
1640006|NCT01933672|3013275|Superiority or Other||Mean Difference (Final Values)|-31.24|||||2-Sided|80.0|-36.35|-26.12||||||Change from baseline|
1640007|NCT01933594|3013276|Superiority|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4|
1640008|NCT01933594|3013276|Superiority|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3|
1640009|NCT01933594|3013276|Superiority|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2|
1640010|NCT01933594|3013276|Superiority|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2|
1640011|NCT01933594|3013276|Superiority|||||||0.027|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1|
1640012|NCT01933594|3013277|Superiority|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4|
1640013|NCT01933594|3013277|Superiority|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3|
1640014|NCT01933594|3013277|Superiority|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2|
1640015|NCT01933594|3013277|Superiority|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2|
1640016|NCT01933594|3013277|Superiority|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1|
1640017|NCT01933594|3013278|Superiority|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change in pS175% on CD8|
1640018|NCT01933594|3013278|Superiority|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change in pNFKB+% on CD8|
1640019|NCT01933594|3013279|Superiority|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Change in pS175% on CD4|
1640020|NCT01933594|3013279|Superiority|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Change in pNFKB+% on CD4|
1640021|NCT01933594|3013280|Superiority|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4|
1640022|NCT01933594|3013280|Superiority|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4|
1640023|NCT01933594|3013280|Superiority|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1|
1640024|NCT01933594|3013281|Superiority|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4|
1640025|NCT01933594|3013281|Superiority|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4|
1640026|NCT01933594|3013281|Superiority|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1|
1640027|NCT01933594|3013282|Superiority|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion|
1640028|NCT01933594|3013282|Superiority|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion|
1640029|NCT01933594|3013282|Superiority|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion|
1640030|NCT01933594|3013283|Superiority|||||||0.031|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion|
1640031|NCT01933594|3013283|Superiority|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion|
1640032|NCT01933594|3013283|Superiority|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion|
1640033|NCT01933594|3013284|Superiority|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4|
1640034|NCT01933594|3013284|Superiority|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4|
1640035|NCT01933594|3013284|Superiority|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1|
1640036|NCT01933594|3013285|Superiority|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4|
1640037|NCT01933594|3013285|Superiority|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4|
1640038|NCT01933594|3013285|Superiority|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1|
1640039|NCT01933594|3013286|Superiority|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4|
1640040|NCT01933594|3013286|Superiority|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||hange from baseline to 24 hours post infusion 4|
1640041|NCT01933594|3013286|Superiority|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1|
1640042|NCT01933594|3013287|Superiority|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4|
1640043|NCT01933594|3013287|Superiority|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4|
1640044|NCT01933594|3013287|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1|
1640045|NCT01933594|3013288|Superiority|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion|
1640046|NCT01933594|3013288|Superiority|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion|
1640047|NCT01933594|3013288|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion|
1640048|NCT01933594|3013289|Superiority|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion|
1640049|NCT01933594|3013289|Superiority|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion|
1640050|NCT01933594|3013289|Superiority|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion|
1640051|NCT01933594|3013290|Superiority|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion|
1640052|NCT01933594|3013290|Superiority|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion|
1640053|NCT01933594|3013290|Superiority|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion|
1640055|NCT01933594|3013291|Superiority|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion|
1640056|NCT01933594|3013291|Superiority|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 48 hours post infusion|
1640057|NCT01933594|3013293|Superiority|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 18 weeks post infusion 4|
1640058|NCT01933594|3013293|Superiority|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 10 weeks post infusion 4|
1640059|NCT01933594|3013293|Superiority|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 5 weeks post infusion 4|
1640060|NCT01933594|3013293|Superiority|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 2 weeks post infusion 4|
1640061|NCT01933594|3013293|Superiority|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4|
1640062|NCT01933594|3013293|Superiority|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3|
1640063|NCT01933594|3013293|Superiority|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2|
1640064|NCT01933594|3013293|Superiority|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1|
1640065|NCT01933594|3013301|Superiority|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4|
1640066|NCT01933594|3013301|Superiority|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3|
1640067|NCT01933594|3013301|Superiority|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2|
1640068|NCT01933594|3013301|Superiority|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2|
1640069|NCT01933594|3013301|Superiority|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1|
1640070|NCT01933594|3013302|Superiority|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 14 days post infusion|
1640071|NCT01933594|3013302|Superiority|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion|
1640072|NCT01933594|3013303|Superiority|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4|
1640073|NCT01933594|3013303|Superiority|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3|
1640074|NCT01933594|3013303|Superiority|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 72 hours post infusion 2|
1640075|NCT01933594|3013303|Superiority|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2|
1640076|NCT01933594|3013303|Superiority|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1|
1640077|NCT01933594|3013305|Superiority|||||||0.54|||||||Wilcoxon (Mann-Whitney)||||
1640078|NCT01933594|3013306|Superiority|||||||0.96|||||||Wilcoxon (Mann-Whitney)||||
1640079|NCT01933594|3013307|Superiority|||||||0.029|||||||Wilcoxon (Mann-Whitney)||||
1640080|NCT01933594|3013308|Superiority|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 28 days post infusion|
1640081|NCT01933594|3013308|Superiority|||||||0.79|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 14 days post infusion|
1640082|NCT01933594|3013308|Superiority|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 7 days post infusion|
1640083|NCT01933594|3013308|Superiority|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 12 hours post infusion|
1640084|NCT01933594|3013308|Superiority|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 6 hours post infusion|
1640085|NCT01933594|3013309|Superiority|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4|
1640086|NCT01933594|3013309|Superiority|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3|
1640087|NCT01933594|3013309|Superiority|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2|
1640088|NCT01933594|3013309|Superiority|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1|
1640089|NCT01933594|3013310|Superiority|||||||0.37|||||||Wilcoxon (Mann-Whitney)||||
1640090|NCT01933594|3013311|Superiority|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 4|
1640091|NCT01933594|3013311|Superiority|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 3|
1640092|NCT01933594|3013311|Superiority|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 2|
1640093|NCT01933594|3013311|Superiority|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 24 hours post infusion 1|
1640094|NCT01933594|3013312|Superiority|||||||0.88|||||||Wilcoxon (Mann-Whitney)||||
1640095|NCT01933425|3013321|Superiority or Other||Mean Difference (Net)|0.3|||<|0.05|2-Sided|95.0|0.06|0.54|||t-test, 2 sided||||
1640096|NCT01933425|3013322|Superiority or Other||Mean Difference (Final Values)|0.33|||<|0.05|2-Sided|95.0|0.07|0.59|||t-test, 2 sided||||
1640097|NCT01933399|3013323|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.05|2-Sided|95.0|-2.1|0.0|||ANCOVA|||Adjusted for baseline.|
1640098|NCT01933399|3013323|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.01|2-Sided|95.0|-2.3|-0.4|||ANCOVA|||Adjusted for baseline.|
1640099|NCT01933399|3013324|Superiority or Other||Mean Difference (Final Values)|5.3||||0.16|2-Sided|95.0|-2.0|12.6||a priori threshold determined to be .05. no adjustments for multiple comparisons.|ANCOVA|Adjustment for baseline.|||
1640100|NCT01933399|3013324|Superiority or Other||Mean Difference (Final Values)|9.4||||0.01|2-Sided|95.0|2.2|16.6|||ANCOVA||"Difference in mean change in scores from baseline to follow-up by treatment group with no adjusment for baseline.~a priori threshold determined to be .05. no adjustments for multiple comparisons."|ANCOVA Adjusted for baseline score|
1640101|NCT01933048|3013339|Non-Inferiority or Equivalence|non-inferiority||||||0.16|||||||Farrington-Manning Method|based on margin of 0.05||B/Brisbane|
1640102|NCT01933048|3013339|Non-Inferiority or Equivalence|non-inferiority||||||0.55|||||||Farrington-Manning Method|based on margin of 0.05||B/Yamagata|
1640103|NCT01933048|3013339|Non-Inferiority or Equivalence|non-inferiority||||||0.8|||||||Farrington-Manning Method|based on margin of 0.05||A/H3N2|
1640104|NCT01933048|3013339|Non-Inferiority or Equivalence|non-inferiority||||||0.43|||||||Farrington-Manning Method|based on margin of 0.05||A/H1N1|
1640105|NCT01932606|3013364|Superiority or Other|||||||0.0002|||||||t-test, 2 sided|||Comparison between the arms for change in stroke volume after study drug (exercise).|
1640106|NCT01932606|3013365|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||Comparison between the arms for change in cardiac output after study drug (exercise).|
1640107|NCT01932606|3013366|Superiority or Other|||||||0.6|||||||t-test, 2 sided|||Comparison between the arms for change in arteriovenous oxygen difference after study drug (exercise).|
1640108|NCT01932606|3013367|Superiority or Other|||||||0.02|||||||t-test, 2 sided|||Comparison between the arms for change in oxygen consumption (VO_2) after study drug (exercise).|
1640109|NCT01932606|3013368|Superiority or Other|||||||0.0003|||||||t-test, 2 sided|||Comparison between the arms for change in LVSW after study drug (exercise)|
1640110|NCT01932606|3013369|Superiority or Other|||||||0.007|||||||t-test, 2 sided|||Comparison between the arms for change in SVR after study drug (exercise).|
1640111|NCT01932606|3013370|Superiority or Other|||||||0.3|||||||t-test, 2 sided|||Comparison between the arms for change in PA compliance after study drug (exercise)|
1640112|NCT01932606|3013371|Superiority or Other|||||||0.3|||||||t-test, 2 sided|||Comparison between the arms for change in PVR after study drug (exercise)|
1640113|NCT01932606|3013372|Superiority or Other|||||||0.05|||||||t-test, 2 sided|||Comparison between the arms for change in diastolic blood pressure.|
1640114|NCT01932606|3013372|Superiority or Other|||||||0.2|||||||t-test, 2 sided|||Comparison between the arms for change in systolic blood pressure.|
1640115|NCT01932606|3013373|Superiority or Other|||||||0.3|||||||t-test, 2 sided|||Comparison between the arms for change in heart rate.|
1640116|NCT01932606|3013374|Superiority or Other|||||||0.0002|||||||t-test, 2 sided|||Comparison between the arms for change in PCWP (exercise).|
1640117|NCT01932606|3013374|Superiority or Other|||||||0.0002|||||||t-test, 2 sided|||Comparison between the arms for change in mean pulmonary artery pressure (exercise).|
1640118|NCT01932606|3013374|Superiority or Other|||||||0.01|||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery systolic pressure (exercise).|
1640119|NCT01932606|3013374|Superiority or Other|||||||0.0002|||||||t-test, 2 sided|||Comparison between the arms for change in right atrial pressure (exercise).|
1640120|NCT01932606|3013375|Superiority or Other|||||||0.4|||||||t-test, 2 sided|||Comparison between the arms for change in stroke volume.|
1640121|NCT01932606|3013376|Superiority or Other|||||||0.4|||||||t-test, 2 sided|||Comparison between the arms for change in cardiac output.|
1640122|NCT01932606|3013377|Superiority or Other|||||||0.1|||||||t-test, 2 sided|||Comparison between the arms for arteriovenous oxygen content difference.|
1640123|NCT01932606|3013378|Superiority or Other|||||||0.8|||||||t-test, 2 sided|||Comparison between the arms for change in VO_2.|
1640124|NCT01932606|3013379|Superiority or Other|||||||0.3|||||||t-test, 2 sided|||Comparison between the arms for change in LVSW.|
1640125|NCT01932606|3013380|Superiority or Other|||||||0.3|||||||t-test, 2 sided|||Comparison between the arms for change in SVR.|
1640126|NCT01932606|3013381|Superiority or Other|||||||0.1|||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery compliance.|
1640127|NCT01932606|3013382|Superiority or Other|||||||0.7|||||||t-test, 2 sided|||Comparison between the arms for change in PVR.|
1640128|NCT01932606|3013383|Superiority or Other|||||||0.2|||||||t-test, 2 sided|||Comparison between the arms for change in mean blood pressure.|
1640129|NCT01932606|3013383|Superiority or Other|||||||0.11|||||||t-test, 2 sided|||Comparison between the arms for change in systolic blood pressure.|
1640130|NCT01932606|3013384|Superiority or Other|||||||0.15|||||||t-test, 2 sided||||
1640131|NCT01932606|3013385|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Comparison between the 2 arms for change in PCWP.|
1640132|NCT01932606|3013385|Superiority or Other||||||<|0.002|||||||t-test, 2 sided|||Comparison between the arms for change in mean pulmonary artery pressure.|
1640133|NCT01932606|3013385|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|||Comparison between the arms for change in pulmonary artery systolic pressure.|
1640134|NCT01932606|3013385|Superiority or Other||||||<|0.0003|||||||t-test, 2 sided|||Comparison between the arms for change in right atrial pressure.|
1640135|NCT01932606|3013386|Superiority or Other|||||||0.0003|||||||ANCOVA||||
1640136|NCT01931878|3013513|Superiority or Other|||||||0.0855|||||||Fisher Exact||||
1640137|NCT01931878|3013514|Superiority or Other|||||||0.0088|||||||Fisher Exact||||
1640138|NCT01931878|3013515|Superiority or Other|||||||0.031|||||||t-test, 2 sided|||comparison of mean RLS Scale scores between 21 incoA and 21 saline injections|
1640139|NCT01931670|3013554|Superiority||Difference in LS Means|-2.28|Standard Error of the Mean|0.738||0.002|2-Sided|95.0|-3.73|-0.83|||ANCOVA|||Month 6|
1640140|NCT01931670|3013554|Superiority||Difference in LS Means|-1.59|Standard Error of the Mean|0.778||0.042|2-Sided|95.0|-3.12|-0.06|||ANCOVA|||Month 6|
1640141|NCT01931670|3013554|Superiority||Difference in LS Means|-2.54|Standard Error of the Mean|0.848||0.003|2-Sided|95.0|-4.21|-0.87|||ANCOVA|||Month 5|
1640142|NCT01931670|3013554|Superiority||Difference in LS Means|-2.04|Standard Error of the Mean|0.856||0.017|2-Sided|95.0|-3.72|-0.36|||ANCOVA|||Month 5|
1640143|NCT01931670|3013554|Superiority||Difference in LS Means|-2.17|Standard Error of the Mean|0.703||0.002|2-Sided|95.0|-3.55|-0.79|||ANCOVA|||Month 4|
1640144|NCT01931670|3013554|Superiority||Difference in LS Means|-0.31|Standard Error of the Mean|0.737||0.675|2-Sided|95.0|-1.76|1.14|||ANCOVA|||Month 4|
1640145|NCT01931670|3013554|Superiority||Difference in LS Means|-0.97|Standard Error of the Mean|0.707||0.169|2-Sided|95.0|-2.36|0.41|||ANCOVA|||Month 3|
1640146|NCT01931670|3013554|Superiority||Difference in LS Means|-0.48|Standard Error of the Mean|0.71||0.503|2-Sided|95.0|-1.87|0.92|||ANCOVA|||Month 3|
1640147|NCT01931670|3013554|Superiority||Difference in LS Means|-1.77|Standard Error of the Mean|0.656||0.007|2-Sided|95.0|-3.06|-0.48|||ANCOVA|||Month 2|
1640148|NCT01931670|3013554|Superiority||Difference in LS Means|-1.33|Standard Error of the Mean|0.652||0.042|2-Sided|95.0|-2.61|-0.05|||ANCOVA|||Month 2|
1640149|NCT01931670|3013554|Superiority||Difference in LS Means|-0.72|Standard Error of the Mean|0.611||0.242|2-Sided|95.0|-1.91|0.48|||ANCOVA|||Month 1|
1640150|NCT01931670|3013554|Superiority||Difference in LS Means|-0.6|Standard Error of the Mean|0.62||0.335|2-Sided|95.0|-1.81|0.62|||ANCOVA|||Month 1|
1640151|NCT01931670|3013555|Superiority||Difference in LS Means|-3.97|Standard Error of the Mean|1.241||0.001|2-Sided|95.0|-6.42|-1.53|||ANCOVA|||Month 6|
1640152|NCT01931670|3013555|Superiority||Difference in LS Means|-1.28|Standard Error of the Mean|1.264||0.311|2-Sided|95.0|-3.77|1.2|||ANCOVA|||Month 6|
1640153|NCT01931670|3013555|Superiority||Difference in LS Means|-5.83|Standard Error of the Mean|1.095|<|0.001|2-Sided|95.0|-7.98|-3.68|||ANCOVA|||Month 5|
1640154|NCT01931670|3013555|Superiority||Difference in LS Means|-2.49|Standard Error of the Mean|1.095|<|0.023|2-Sided|95.0|-4.64|-0.34|||ANCOVA|||Month 5|
1640155|NCT01931670|3013555|Superiority||Difference in LS Means|-6.27|Standard Error of the Mean|1.124|<|0.001|2-Sided|95.0|-8.48|-4.06|||ANCOVA|||Month 4|
1640156|NCT01931670|3013555|Superiority||Difference in LS Means|-2.72|Standard Error of the Mean|1.138|<|0.017|2-Sided|95.0|-4.95|-0.48|||ANCOVA|||Month 4|
1640157|NCT01931670|3013555|Superiority||Difference in LS Means|-4.64|Standard Error of the Mean|1.135|<|0.001|2-Sided|95.0|-6.87|-2.41|||ANCOVA|||Month 3|
1640158|NCT01931670|3013555|Superiority||Difference in LS Means|-2.65|Standard Error of the Mean|1.14|<|0.02|2-Sided|95.0|-4.89|-0.41|||ANCOVA|||Month 3|
1640159|NCT01931670|3013555|Superiority||Difference in LS Means|-5.1|Standard Error of the Mean|1.089|<|0.001|2-Sided|95.0|-7.24|-2.96|||ANCOVA|||Month 2|
1640160|NCT01931670|3013555|Superiority||Difference in LS Means|-2.02|Standard Error of the Mean|1.091|<|0.065|2-Sided|95.0|-4.16|0.13|||ANCOVA|||Month 2|
1640161|NCT01931670|3013555|Superiority||Difference in LS Means|-3.72|Standard Error of the Mean|1.113|<|0.001|2-Sided|95.0|-5.91|-1.54|||ANCOVA|||Month 1|
1640162|NCT01931670|3013555|Superiority||Difference in LS Means|-1.83|Standard Error of the Mean|1.106|<|0.098|2-Sided|95.0|-4.01|0.34|||ANCOVA|||Month 1|
1640163|NCT01931670|3013556|Superiority||Difference in LS Means|-0.86|Standard Error of the Mean|0.474||0.071|2-Sided|95.0|-1.79|0.07|||ANCOVA|||Month 6|
1640164|NCT01931670|3013556|Superiority||Difference in LS Means|-0.83|Standard Error of the Mean|0.498||0.095|2-Sided|95.0|-1.81|0.15|||ANCOVA|||Month 6|
1640165|NCT01931670|3013556|Superiority||Difference in LS Means|-0.9|Standard Error of the Mean|0.63||0.152|2-Sided|95.0|-2.14|0.33|||ANCOVA|||Month 5|
1640166|NCT01931670|3013556|Superiority||Difference in LS Means|-0.89|Standard Error of the Mean|0.635||0.16|2-Sided|95.0|-2.14|0.35|||ANCOVA|||Month 5|
1640167|NCT01931670|3013556|Superiority||Difference in LS Means|-0.93|Standard Error of the Mean|0.468||0.048|2-Sided|95.0|-1.85|-0.01|||ANCOVA|||Month 4|
1640168|NCT01931670|3013556|Superiority||Difference in LS Means|0.08|Standard Error of the Mean|0.491||0.874|2-Sided|95.0|-0.89|1.04|||ANCOVA|||Month 4|
1640169|NCT01931670|3013556|Superiority||Difference in LS Means|-0.15|Standard Error of the Mean|0.505||0.761|2-Sided|95.0|-1.15|0.84|||ANCOVA|||Month 3|
1640170|NCT01931670|3013556|Superiority||Difference in LS Means|0.43|Standard Error of the Mean|0.505||0.398|2-Sided|95.0|-0.56|1.42|||ANCOVA|||Month 3|
1640171|NCT01931670|3013556|Superiority||Difference in LS Means|-0.4|Standard Error of the Mean|0.393||0.311|2-Sided|95.0|-1.17|0.37|||ANCOVA|||Month 2|
1640172|NCT01931670|3013556|Superiority||Difference in LS Means|-0.22|Standard Error of the Mean|0.389||0.569|2-Sided|95.0|-0.99|0.54|||ANCOVA|||Month 2|
1640173|NCT01931670|3013556|Superiority||Difference in LS Means|-0.02|Standard Error of the Mean|0.415||0.969|2-Sided|95.0|-0.83|0.8|||ANCOVA|||Month 1|
1640174|NCT01931670|3013556|Superiority||Difference in LS Means|0.01|Standard Error of the Mean|0.422||0.975|2-Sided|95.0|-0.81|0.84|||ANCOVA|||Month 1|
1640175|NCT01931670|3013557|Superiority||Difference in LS Means|-3.02|Standard Error of the Mean|1.092||0.006|2-Sided|95.0|-5.17|-0.87|||ANCOVA|||Month 6|
1640176|NCT01931670|3013557|Superiority||Difference in LS Means|-0.97|Standard Error of the Mean|1.112||0.383|2-Sided|95.0|-3.16|1.22|||ANCOVA|||Month 6|
1640177|NCT01931670|3013557|Superiority||Difference in LS Means|-5.14|Standard Error of the Mean|0.975|<|0.001|2-Sided|95.0|-7.06|-3.22|||ANCOVA|||Month 5|
1640178|NCT01931670|3013557|Superiority||Difference in LS Means|-2.29|Standard Error of the Mean|0.97|<|0.019|2-Sided|95.0|-4.2|-0.38|||ANCOVA|||Month 5|
1640179|NCT01931670|3013557|Superiority||Difference in LS Means|-4.78|Standard Error of the Mean|0.99|<|0.001|2-Sided|95.0|-6.72|-2.83|||ANCOVA|||Month 4|
1640180|NCT01931670|3013557|Superiority||Difference in LS Means|-1.63|Standard Error of the Mean|0.998|<|0.103|2-Sided|95.0|-3.59|0.33|||ANCOVA|||Month 4|
1640181|NCT01931670|3013557|Superiority||Difference in LS Means|-3.2|Standard Error of the Mean|1.021|<|0.002|2-Sided|95.0|-5.21|-1.19|||ANCOVA|||Month 3|
1640182|NCT01931670|3013557|Superiority||Difference in LS Means|-2.03|Standard Error of the Mean|1.02|<|0.047|2-Sided|95.0|-4.03|-0.02|||ANCOVA|||Month 3|
1640183|NCT01931670|3013557|Superiority||Difference in LS Means|-3.65|Standard Error of the Mean|1.007|<|0.001|2-Sided|95.0|-5.63|-1.67|||ANCOVA|||Month 2|
1640184|NCT01931670|3013557|Superiority||Difference in LS Means|-1.31|Standard Error of the Mean|1.005|<|0.195|2-Sided|95.0|-3.28|0.67|||ANCOVA|||Month 2|
1640185|NCT01931670|3013557|Superiority||Difference in LS Means|-3.09|Standard Error of the Mean|1.013|<|0.002|2-Sided|95.0|-5.08|-1.1|||ANCOVA|||Month 1|
1640186|NCT01931670|3013557|Superiority||Difference in LS Means|-1.34|Standard Error of the Mean|1.01|<|0.186|2-Sided|95.0|-3.32|0.65|||ANCOVA|||Month 1|
1640187|NCT01931670|3013558|Superiority||Difference in LS Means|-1.45|Standard Error of the Mean|0.454||0.001|2-Sided|95.0|-2.34|-0.56|||ANCOVA|||Month 6|
1640188|NCT01931670|3013558|Superiority||Difference in LS Means|-0.73|Standard Error of the Mean|0.478||0.13|2-Sided|95.0|-1.67|0.21|||ANCOVA|||Month 6|
1640189|NCT01931670|3013558|Superiority||Difference in LS Means|-1.64|Standard Error of the Mean|0.439|<|0.001|2-Sided|95.0|-2.5|-0.78|||ANCOVA|||Month 5|
1640190|NCT01931670|3013558|Superiority||Difference in LS Means|-1.12|Standard Error of the Mean|0.443|<|0.012|2-Sided|95.0|-1.99|-0.25|||ANCOVA|||Month 5|
1640191|NCT01931670|3013558|Superiority||Difference in LS Means|-1.33|Standard Error of the Mean|0.432|<|0.002|2-Sided|95.0|-2.18|-0.48|||ANCOVA|||Month 4|
1640192|NCT01931670|3013558|Superiority||Difference in LS Means|-0.34|Standard Error of the Mean|0.453|<|0.452|2-Sided|95.0|-1.23|0.55|||ANCOVA|||Month 4|
1640193|NCT01931670|3013558|Superiority||Difference in LS Means|-0.91|Standard Error of the Mean|0.431|<|0.035|2-Sided|95.0|-1.76|-0.06|||ANCOVA|||Month 3|
1640194|NCT01931670|3013558|Superiority||Difference in LS Means|-0.91|Standard Error of the Mean|0.434|<|0.036|2-Sided|95.0|-1.76|-0.06|||ANCOVA|||Month 3|
1640195|NCT01931670|3013558|Superiority||Difference in LS Means|-1.44|Standard Error of the Mean|0.426|<|0.001|2-Sided|95.0|-2.27|-0.6|||ANCOVA|||Month 2|
1640196|NCT01931670|3013558|Superiority||Difference in LS Means|-1.12|Standard Error of the Mean|0.423|<|0.008|2-Sided|95.0|-1.96|-0.29|||ANCOVA|||Month 2|
1640197|NCT01931670|3013558|Superiority||Difference in LS Means|-0.85|Standard Error of the Mean|0.409|<|0.037|2-Sided|95.0|-1.65|-0.05|||ANCOVA|||Month 1|
1640198|NCT01931670|3013558|Superiority||Difference in LS Means|-0.63|Standard Error of the Mean|0.415|<|0.131|2-Sided|95.0|-1.44|0.19|||ANCOVA|||Month 1|
1640199|NCT01931670|3013559|Superiority||Difference in LS Means|-0.91|Standard Error of the Mean|0.385||0.019|2-Sided|95.0|-1.67|-0.15|||ANCOVA|||Month 6|
1640200|NCT01931670|3013559|Superiority||Difference in LS Means|-0.57|Standard Error of the Mean|0.391||0.143|2-Sided|95.0|-1.34|0.2|||ANCOVA|||Month 6|
1640201|NCT01931670|3013559|Superiority||Difference in LS Means|-1.11|Standard Error of the Mean|0.327|<|0.001|2-Sided|95.0|-1.75|-0.47|||ANCOVA|||Month 5|
1640202|NCT01931670|3013559|Superiority||Difference in LS Means|-0.73|Standard Error of the Mean|0.327|<|0.027|2-Sided|95.0|-1.37|-0.08|||ANCOVA|||Month 5|
1640203|NCT01931670|3013559|Superiority||Difference in LS Means|-1.48|Standard Error of the Mean|0.555|<|0.008|2-Sided|95.0|-2.57|-0.39|||ANCOVA|||Month 4|
1640204|NCT01931670|3013559|Superiority||Difference in LS Means|-1.25|Standard Error of the Mean|0.561|<|0.026|2-Sided|95.0|-2.35|-0.15|||ANCOVA|||Month 4|
1640205|NCT01931670|3013559|Superiority||Difference in LS Means|-1.41|Standard Error of the Mean|0.431|<|0.001|2-Sided|95.0|-2.25|-0.56|||ANCOVA|||Month 3|
1640206|NCT01931670|3013559|Superiority||Difference in LS Means|-0.67|Standard Error of the Mean|0.432|<|0.121|2-Sided|95.0|-1.52|0.18|||ANCOVA|||Month 3|
1640207|NCT01931670|3013559|Superiority||Difference in LS Means|-1.44|Standard Error of the Mean|0.397|<|0.001|2-Sided|95.0|-2.22|-0.65|||ANCOVA|||Month 2|
1640208|NCT01931670|3013559|Superiority||Difference in LS Means|-0.98|Standard Error of the Mean|0.397|<|0.014|2-Sided|95.0|-1.76|-0.2|||ANCOVA|||Month 2|
1640209|NCT01931670|3013559|Superiority||Difference in LS Means|-0.95|Standard Error of the Mean|0.433|<|0.028|2-Sided|95.0|-1.8|-0.1|||ANCOVA|||Month 1|
1640210|NCT01931670|3013559|Superiority||Difference in LS Means|-1.01|Standard Error of the Mean|0.43|<|0.019|2-Sided|95.0|-1.86|-0.17|||ANCOVA|||Month 1|
1640211|NCT01931670|3013560|Superiority||Difference in LS Means|-14.1|Standard Error of the Mean|2.82|<|0.001|2-Sided|95.0|-19.64|-8.55|||ANCOVA|||Month 6|
1640212|NCT01931670|3013560|Superiority||Difference in LS Means|-2.93|Standard Error of the Mean|2.91|<|0.315|2-Sided|95.0|-8.66|2.8|||ANCOVA|||Month 6|
1640213|NCT01931670|3013560|Superiority||Difference in LS Means|-10.69|Standard Error of the Mean|2.38|<|0.001|2-Sided|95.0|-15.37|-6.01|||ANCOVA|||Month 3|
1640214|NCT01931670|3013560|Superiority||Difference in LS Means|-2.74|Standard Error of the Mean|2.42|<|0.257|2-Sided|95.0|-7.5|2.01|||ANCOVA|||Month 3|
1640215|NCT01931670|3013560|Superiority||Difference in LS Means|-4.4|Standard Error of the Mean|1.93|<|0.023|2-Sided|95.0|-8.19|-0.61|||ANCOVA|||Month 1|
1640216|NCT01931670|3013560|Superiority||Difference in LS Means|-0.57|Standard Error of the Mean|1.95|<|0.77|2-Sided|95.0|-4.4|3.26|||ANCOVA|||Month 1|
1640217|NCT01931670|3013561|Superiority||Difference in LS Means|-16.92|Standard Error of the Mean|2.07|<|0.001|2-Sided|95.0|-20.98|-12.86|||ANCOVA|||Month 6|
1640218|NCT01931670|3013561|Superiority||Difference in LS Means|-8.7|Standard Error of the Mean|2.09|<|0.001|2-Sided|95.0|-12.81|-4.6|||ANCOVA|||Month 6|
1640219|NCT01931670|3013561|Superiority||Difference in LS Means|-15.43|Standard Error of the Mean|1.75|<|0.001|2-Sided|95.0|-18.87|-11.99|||ANCOVA|||Month 3|
1640220|NCT01931670|3013561|Superiority||Difference in LS Means|-7.33|Standard Error of the Mean|1.74|<|0.001|2-Sided|95.0|-10.75|-3.91|||ANCOVA|||Month 3|
1640221|NCT01931670|3013561|Superiority||Difference in LS Means|-7.55|Standard Error of the Mean|1.55|<|0.001|2-Sided|95.0|-10.6|-4.5|||ANCOVA|||Month 1|
1640222|NCT01931670|3013561|Superiority||Difference in LS Means|-4.2|Standard Error of the Mean|1.55|<|0.007|2-Sided|95.0|-7.25|-1.16|||ANCOVA|||Month 1|
1640223|NCT01931670|3013562|Superiority||LS Mean of Difference|-1.28|Standard Error of the Mean|0.175|<|0.001|2-Sided|97.5|-1.67|-0.89|||mixed-effects model|||Month 6|
1640224|NCT01931670|3013562|Superiority||LS Mean of Difference|-0.69|Standard Error of the Mean|0.175|<|0.001|2-Sided|97.5|-1.08|-0.3|||mixed-effects model|||Month 6|
1640225|NCT01931670|3013562|Superiority||LS Mean of Difference|-1.37|Standard Error of the Mean|0.168|<|0.001|2-Sided|97.5|-1.75|-1.0|||mixed-effects model|||Month 5|
1640226|NCT01931670|3013562|Superiority||LS Mean of Difference|-0.61|Standard Error of the Mean|0.168|<|0.001|2-Sided|97.5|-0.99|-0.23|||mixed-effects model|||Month 5|
1640227|NCT01931670|3013562|Superiority||LS Mean of Difference|-1.36|Standard Error of the Mean|0.164|<|0.001|2-Sided|97.5|-1.72|-0.99|||mixed-effects model|||Month 4|
1640228|NCT01931670|3013562|Superiority||LS Mean of Difference|-0.58|Standard Error of the Mean|0.164|<|0.001|2-Sided|97.5|-0.95|-0.21|||mixed-effects model|||Month 4|
1640229|NCT01931670|3013562|Superiority||LS Mean of Difference|-0.96|Standard Error of the Mean|0.137|<|0.001|2-Sided|97.5|-1.27|-0.65|||mixed-effects model|||Month 2|
1640230|NCT01931670|3013562|Superiority||LS Mean of Difference|-0.54|Standard Error of the Mean|0.137|<|0.001|2-Sided|97.5|-0.85|-0.23|||mixed-effects model|||Month 2|
1640231|NCT01931670|3013562|Superiority||LS Mean of Difference|-0.45|Standard Error of the Mean|0.119|<|0.001|2-Sided|97.5|-0.72|-0.18|||mixed-effects model|||Month 1|
1640232|NCT01931670|3013562|Superiority||LS Mean of Difference|-0.28|Standard Error of the Mean|0.12|<|0.02|2-Sided|97.5|-0.55|-0.01|||mixed-effects model|||Month 1|
1640233|NCT01931670|3013563|Superiority||LS Mean of Difference|-1.27|Standard Error of the Mean|0.117|<|0.001|2-Sided|95.0|-1.5|-1.04|||ANOVA|||Month 6|
1640234|NCT01931670|3013563|Superiority||LS Mean of Difference|-0.72|Standard Error of the Mean|0.116|<|0.001|2-Sided|95.0|-0.95|-0.49|||ANOVA|||Month 6|
1640235|NCT01931670|3013563|Superiority||LS Mean of Difference|-1.24|Standard Error of the Mean|0.113|<|0.001|2-Sided|95.0|-1.47|-1.02|||ANOVA|||Month 5|
1640236|NCT01931670|3013563|Superiority||LS Mean of Difference|-0.79|Standard Error of the Mean|0.113|<|0.001|2-Sided|95.0|-1.01|-0.57|||ANOVA|||Month 5|
1640237|NCT01931670|3013563|Superiority||LS Mean of Difference|-1.21|Standard Error of the Mean|0.109|<|0.001|2-Sided|95.0|-1.43|-1.0|||ANOVA|||Month 4|
1640238|NCT01931670|3013563|Superiority||LS Mean of Difference|-0.62|Standard Error of the Mean|0.109|<|0.001|2-Sided|95.0|-0.84|-0.41|||ANOVA|||Month 4|
1640239|NCT01931670|3013563|Superiority||LS Mean of Difference|-1.14|Standard Error of the Mean|0.106|<|0.001|2-Sided|95.0|-1.35|-0.93|||ANOVA|||Month 3|
1640240|NCT01931670|3013563|Superiority||LS Mean of Difference|-0.63|Standard Error of the Mean|0.106|<|0.001|2-Sided|95.0|-0.84|-0.42|||ANOVA|||Month 3|
1640241|NCT01931670|3013563|Superiority||LS Mean of Difference|-1.09|Standard Error of the Mean|0.102|<|0.001|2-Sided|95.0|-1.29|-0.89|||ANOVA|||Month 2|
1640242|NCT01931670|3013563|Superiority||LS Mean of Difference|-0.62|Standard Error of the Mean|0.102|<|0.001|2-Sided|95.0|-0.82|-0.42|||ANOVA|||Month 2|
1640243|NCT01931670|3013563|Superiority||LS Mean of Difference|-0.65|Standard Error of the Mean|0.099|<|0.001|2-Sided|95.0|-0.84|-0.46|||ANOVA|||Month 1|
1640244|NCT01931670|3013563|Superiority||LS Mean of Difference|-0.37|Standard Error of the Mean|0.099|<|0.001|2-Sided|95.0|-0.56|-0.18|||ANOVA|||Month 1|
1640245|NCT01931670|3013564|Superiority||LS Mean of Difference|-0.22|Standard Error of the Mean|0.048|<|0.001|2-Sided|97.5|-0.33|-0.11|||mixed-effects model|||Month 5|
1640246|NCT01931670|3013564|Superiority||LS Mean of Difference|-0.05|Standard Error of the Mean|0.049|<|0.284|2-Sided|97.5|-0.16|0.06|||mixed-effects model|||Month 5|
1640247|NCT01931670|3013564|Superiority||LS Mean of Difference|-0.22|Standard Error of the Mean|0.045|<|0.001|2-Sided|97.5|-0.32|-0.12|||mixed-effects model|||Month 4|
1640248|NCT01931670|3013564|Superiority||LS Mean of Difference|-0.09|Standard Error of the Mean|0.045|<|0.058|2-Sided|97.5|-0.19|0.02|||mixed-effects model|||Month 4|
1640249|NCT01931670|3013564|Superiority||LS Mean of Difference|-0.19|Standard Error of the Mean|0.042|<|0.001|2-Sided|97.5|-0.28|-0.09|||mixed-effects model|||Month 2|
1640250|NCT01931670|3013564|Superiority||LS Mean of Difference|-0.08|Standard Error of the Mean|0.042|<|0.076|2-Sided|97.5|-0.17|0.02|||mixed-effects model|||Month 2|
1640251|NCT01931670|3013564|Superiority||LS Mean of Difference|-0.11|Standard Error of the Mean|0.039|<|0.004|2-Sided|97.5|-0.2|-0.03|||mixed-effects model|||Month 1|
1640252|NCT01931670|3013564|Superiority||LS Mean of Difference|-0.09|Standard Error of the Mean|0.04|<|0.029|2-Sided|97.5|-0.18|0.0|||mixed-effects model|||Month 1|
1640253|NCT01931670|3013565|Superiority||LS Mean of Difference|-0.33|Standard Error of the Mean|0.076|<|0.001|2-Sided|97.5|-0.5|-0.16|||mixed-effects model|||Month 6|
1640254|NCT01931670|3013565|Superiority||LS Mean of Difference|-0.06|Standard Deviation|0.076|<|0.468|2-Sided|97.5|-0.23|0.12|||mixed-effects model|||Month 6|
1640255|NCT01931670|3013565|Superiority||LS Mean of Difference|-0.31|Standard Error of the Mean|0.073|<|0.001|2-Sided|97.5|-0.47|-0.15|||mixed-effects model|||Month 5|
1640256|NCT01931670|3013565|Superiority||LS Mean of Difference|-0.02|Standard Error of the Mean|0.072|<|0.765|2-Sided|97.5|-0.18|0.14|||mixed-effects model|||Month 5|
1640257|NCT01931670|3013565|Superiority||LS Mean of Difference|-0.27|Standard Error of the Mean|0.071|<|0.001|2-Sided|97.5|-0.43|-0.11|||mixed-effects model|||Month 4|
1640258|NCT01931670|3013565|Superiority||LS Mean of Difference|-0.05|Standard Error of the Mean|0.071|<|0.494|2-Sided|97.5|-0.21|0.11|||mixed-effects model|||Month 4|
1640259|NCT01931670|3013565|Superiority||LS Mean of Difference|-0.24|Standard Error of the Mean|0.06|<|0.001|2-Sided|97.5|-0.37|-0.1|||mixed-effects model|||Month 2|
1640260|NCT01931670|3013565|Superiority||LS Mean of Difference|-0.07|Standard Error of the Mean|0.06|<|0.277|2-Sided|97.5|-0.2|0.07|||mixed-effects model|||Month 2|
1640261|NCT01931670|3013565|Superiority||LS Mean of Difference|-0.05|Standard Error of the Mean|0.058|<|0.431|2-Sided|97.5|-0.18|0.08|||mixed-effects model|||Month 1|
1640262|NCT01931670|3013565|Superiority||LS Mean of Difference|0.02|Standard Error of the Mean|0.059|<|0.688|2-Sided|97.5|-0.11|0.16|||mixed-effects model|||Month 1|
1640263|NCT01931670|3013566|Superiority||LS Mean of Difference|-21.16|Standard Error of the Mean|3.729|<|0.001|2-Sided|97.5|-29.54|-12.79|||mixed-effects model|||Month 6|
1640264|NCT01931670|3013566|Superiority||LS Mean of Difference|-10.83|Standard Error of the Mean|3.744|<|0.004|2-Sided|97.5|-19.24|-2.43|||mixed-effects model|||Month 6|
1640265|NCT01931670|3013566|Superiority||LS Mean of Difference|-21.66|Standard Error of the Mean|3.52|<|0.001|2-Sided|97.5|-29.56|-13.75|||mixed-effects model|||Month 5|
1640266|NCT01931670|3013566|Superiority||LS Mean of Difference|-6.21|Standard Error of the Mean|3.536|<|0.08|2-Sided|97.5|-14.15|1.73|||mixed-effects model|||Month 5|
1640267|NCT01931670|3013566|Superiority||LS Mean of Difference|-21.58|Standard Error of the Mean|3.46|<|0.001|2-Sided|97.5|-29.35|-13.81|||mixed-effects model|||Month 4|
1640268|NCT01931670|3013566|Superiority||LS Mean of Difference|-6.25|Standard Error of the Mean|3.473|<|0.072|2-Sided|97.5|-14.05|1.55|||mixed-effects model|||Month 4|
1640269|NCT01931670|3013566|Superiority||LS Mean of Difference|-19.05|Standard Error of the Mean|3.364|<|0.001|2-Sided|97.5|-26.61|-11.49|||mixed-effects model|||Month 3|
1640270|NCT01931670|3013566|Superiority||LS Mean of Difference|-6.84|Standard Error of the Mean|3.379|<|0.043|2-Sided|97.5|-14.43|0.75|||mixed-effects model|||Month 3|
1640271|NCT01931670|3013566|Superiority||LS Mean of Difference|-13.19|Standard Error of the Mean|2.956|<|0.001|2-Sided|97.5|-19.83|-6.55|||mixed-effects model|||Month 2|
1640272|NCT01931670|3013566|Superiority||LS Mean of Difference|-5.17|Standard Error of the Mean|2.964|<|0.082|2-Sided|97.5|-11.82|1.49|||mixed-effects model|||Month 2|
1640273|NCT01931670|3013566|Superiority||LS Mean of Difference|-6.43|Standard Error of the Mean|2.92|<|0.028|2-Sided|97.5|-12.99|0.13|||mixed-effects model|||Month 1|
1640274|NCT01931670|3013566|Superiority||LS Mean of Difference|-3.04|Standard Error of the Mean|2.94|<|0.301|2-Sided|97.5|-9.64|3.56|||mixed-effects model|||Month 1|
1640275|NCT01931670|3013567|Superiority||LS Mean of Difference|-0.34|Standard Error of the Mean|0.054|<|0.001|2-Sided|97.5|-0.46|-0.22|||mixed-effects model|||Month 5|
1640276|NCT01931670|3013567|Superiority||LS Mean of Difference|-0.1|Standard Error of the Mean|0.054|<|0.062|2-Sided|97.5|-0.22|0.02|||mixed-effects model|||Month 5|
1640277|NCT01931670|3013567|Superiority||LS Mean of Difference|-0.33|Standard Error of the Mean|0.052|<|0.001|2-Sided|97.5|-0.45|-0.22|||mixed-effects model|||Month 4|
1640278|NCT01931670|3013567|Superiority||LS Mean of Difference|-0.09|Standard Error of the Mean|0.052|<|0.081|2-Sided|97.5|-0.21|0.03|||mixed-effects model|||Month 4|
1640279|NCT01931670|3013567|Superiority||LS Mean of Difference|-0.29|Standard Error of the Mean|0.05|<|0.001|2-Sided|97.5|-0.41|-0.18|||mixed-effects model|||Month 3|
1640280|NCT01931670|3013567|Superiority||LS Mean of Difference|-0.1|Standard Error of the Mean|0.05|<|0.041|2-Sided|97.5|-0.22|0.01|||mixed-effects model|||Month 3|
1640281|NCT01931670|3013567|Superiority||LS Mean of Difference|-0.2|Standard Error of the Mean|0.043|<|0.001|2-Sided|97.5|-0.3|-0.11|||mixed-effects model|||Month 2|
1640282|NCT01931670|3013567|Superiority||LS Mean of Difference|-0.07|Standard Error of the Mean|0.044|<|0.11|2-Sided|97.5|-0.17|0.03|||mixed-effects model|||Month 2|
1640283|NCT01931670|3013567|Superiority||LS Mean of Difference|-0.09|Standard Error of the Mean|0.04|<|0.02|2-Sided|97.5|-0.18|0.0|||mixed-effects model|||Month 1|
1640284|NCT01931670|3013567|Superiority||LS Mean of Difference|-0.02|Standard Error of the Mean|0.04|<|0.549|2-Sided|97.5|-0.11|0.07|||mixed-effects model|||Month 1|
1640285|NCT01931670|3013568|Superiority||LS Mean of Difference|-56.62|Standard Error of the Mean|3.522|<|0.001|2-Sided|97.5|-64.53|-48.7|||mixed-effects model|||Month 6|
1640286|NCT01931670|3013568|Superiority||LS Mean of Difference|-25.89|Standard Error of the Mean|3.528|<|0.001|2-Sided|97.5|-33.81|-17.97|||mixed-effects model|||Month 6|
1640287|NCT01931670|3013568|Superiority||LS Mean of Difference|-62.9|Standard Error of the Mean|3.42|<|0.001|2-Sided|97.5|-70.58|-55.22|||mixed-effects model|||Month 5|
1640288|NCT01931670|3013568|Superiority||LS Mean of Difference|-23.36|Standard Error of the Mean|3.428|<|0.001|2-Sided|97.5|-31.06|-15.66|||mixed-effects model|||Month 5|
1640289|NCT01931670|3013568|Superiority||LS Mean of Difference|-62.37|Standard Error of the Mean|3.346|<|0.001|2-Sided|97.5|-69.89|-54.86|||mixed-effects model|||Month 4|
1640290|NCT01931670|3013568|Superiority||LS Mean of Difference|-26.97|Standard Error of the Mean|3.344|<|0.001|2-Sided|97.5|-34.48|-19.46|||mixed-effects model|||Month 4|
1640291|NCT01931670|3013568|Superiority||LS Mean of Difference|-61.94|Standard Error of the Mean|3.233|<|0.001|2-Sided|97.5|-69.2|-54.68|||mixed-effects model|||Month 3|
1640292|NCT01931670|3013568|Superiority||LS Mean of Difference|-25.15|Standard Error of the Mean|3.241|<|0.001|2-Sided|97.5|-32.43|-17.88|||mixed-effects model|||Month 3|
1640293|NCT01931670|3013568|Superiority||LS Mean of Difference|-63.31|Standard Error of the Mean|3.365|<|0.001|2-Sided|97.5|-70.87|-55.76|||mixed-effects model|||Month 2|
1640294|NCT01931670|3013568|Superiority||LS Mean of Difference|-21.9|Standard Error of the Mean|3.355|<|0.001|2-Sided|97.5|-29.44|-14.36|||mixed-effects model|||Month 2|
1640295|NCT01931670|3013568|Superiority||LS Mean of Difference|-39.32|Standard Error of the Mean|3.657|<|0.001|2-Sided|97.5|-47.53|-31.11|||mixed-effects model|||Month 1|
1640296|NCT01931670|3013568|Superiority||LS Mean of Difference|-25.31|Standard Error of the Mean|3.669|<|0.001|2-Sided|97.5|-33.55|-17.07|||mixed-effects model|||Month 1|
1640297|NCT01931670|3013569|Superiority||LS Mean of Difference|-1.26|Standard Error of the Mean|0.071|<|0.001|2-Sided|97.5|-1.42|-1.1|||mixed-effects model|||Month 5|
1640298|NCT01931670|3013569|Superiority||LS Mean of Difference|-0.49|Standard Error of the Mean|0.071|<|0.001|2-Sided|97.5|-0.65|-0.33|||mixed-effects model|||Month 5|
1640299|NCT01931670|3013569|Superiority||LS Mean of Difference|-1.27|Standard Error of the Mean|0.07|<|0.001|2-Sided|97.5|-1.42|-1.11|||mixed-effects model|||Month 4|
1640300|NCT01931670|3013569|Superiority||LS Mean of Difference|-0.58|Standard Error of the Mean|0.07|<|0.001|2-Sided|97.5|-0.73|-0.42|||mixed-effects model|||Month 4|
1640301|NCT01931670|3013569|Superiority||LS Mean of Difference|-1.25|Standard Error of the Mean|0.067|<|0.001|2-Sided|97.5|-1.4|-1.09|||mixed-effects model|||Month 3|
1640302|NCT01931670|3013569|Superiority||LS Mean of Difference|-0.53|Standard Error of the Mean|0.068|<|0.001|2-Sided|97.5|-0.68|-0.37|||mixed-effects model|||Month 3|
1640303|NCT01931670|3013569|Superiority||LS Mean of Difference|-1.27|Standard Error of the Mean|0.068|<|0.001|2-Sided|97.5|-1.43|-1.12|||mixed-effects model|||Month 2|
1640304|NCT01931670|3013569|Superiority||LS Mean of Difference|-0.44|Standard Error of the Mean|0.068|<|0.001|2-Sided|97.5|-0.6|-0.29|||mixed-effects model|||Month 2|
1640305|NCT01931670|3013569|Superiority||LS Mean of Difference|-0.78|Standard Error of the Mean|0.071|<|0.001|2-Sided|97.5|-0.94|-0.62|||mixed-effects model|||Month 1|
1640306|NCT01931670|3013569|Superiority||LS Mean of Difference|-0.53|Standard Error of the Mean|0.071|<|0.001|2-Sided|97.5|-0.69|-0.37|||mixed-effects model|||Month 1|
1640307|NCT01931670|3013570|Superiority||Odds Ratio (OR)|1.997|||<|0.001|2-Sided|97.5|1.253|3.183|||Regression, Logistic|||Month 6|
1640308|NCT01931670|3013570|Superiority||Odds Ratio (OR)|1.013|||<|0.953|2-Sided|97.5|0.631|1.624|||Regression, Logistic|||Month 6|
1640309|NCT01931670|3013570|Superiority||Odds Ratio (OR)|2.416|||<|0.001|2-Sided|97.5|1.5|3.891|||Regression, Logistic|||Month 5|
1640310|NCT01931670|3013570|Superiority||Odds Ratio (OR)|1.262|||<|0.27|2-Sided|97.5|0.787|2.023|||Regression, Logistic|||Month 5|
1640311|NCT01931670|3013570|Superiority||Odds Ratio (OR)|2.474|||<|0.001|2-Sided|97.5|1.544|3.963|||Regression, Logistic|||Month 4|
1640312|NCT01931670|3013570|Superiority||Odds Ratio (OR)|1.145|||<|0.521|2-Sided|97.5|0.713|1.839|||Regression, Logistic|||Month 4|
1640313|NCT01931670|3013570|Superiority||Odds Ratio (OR)|1.865|||<|0.003|2-Sided|97.5|1.163|2.989|||Regression, Logistic|||Month 3|
1640314|NCT01931670|3013570|Superiority||Odds Ratio (OR)|1.25|||<|0.294|2-Sided|97.5|0.776|2.013|||Regression, Logistic|||Month 3|
1640315|NCT01931670|3013570|Superiority||Odds Ratio (OR)|1.871|||<|0.003|2-Sided|97.5|1.175|2.979|||Regression, Logistic|||Month 2|
1640316|NCT01931670|3013570|Superiority||Odds Ratio (OR)|1.351|||<|0.154|2-Sided|97.5|0.841|2.17|||Regression, Logistic|||Month 2|
1640317|NCT01931670|3013570|Superiority||Odds Ratio (OR)|1.103|||<|0.65|2-Sided|97.5|0.68|1.789|||Regression, Logistic|||Month 1|
1640318|NCT01931670|3013570|Superiority||Odds Ratio (OR)|1.028|||<|0.901|2-Sided|97.5|0.624|1.693|||Regression, Logistic|||Month 1|
1640319|NCT01931670|3013571|Superiority||Odds Ratio (OR)|2.412|||<|0.001|2-Sided|97.5|1.63|3.57|||Regression, Logistic|||Month 6|
1640320|NCT01931670|3013571|Superiority||Odds Ratio (OR)|1.565|||<|0.01|2-Sided|97.5|1.062|2.306|||Regression, Logistic|||Month 6|
1640321|NCT01931670|3013571|Superiority||Odds Ratio (OR)|2.598|||<|0.001|2-Sided|97.5|1.75|3.857|||Regression, Logistic|||Month 5|
1640322|NCT01931670|3013571|Superiority||Odds Ratio (OR)|1.537|||<|0.013|2-Sided|97.5|1.042|2.267|||Regression, Logistic|||Month 5|
1640323|NCT01931670|3013571|Superiority||Odds Ratio (OR)|2.722|||<|0.001|2-Sided|97.5|1.832|4.044|||Regression, Logistic|||Month 4|
1640324|NCT01931670|3013571|Superiority||Odds Ratio (OR)|1.678|||<|0.003|2-Sided|97.5|1.136|2.477|||Regression, Logistic|||Month 4|
1640325|NCT01931670|3013571|Superiority||Odds Ratio (OR)|2.208|||<|0.001|2-Sided|97.5|1.488|3.278|||Regression, Logistic|||Month 2|
1640326|NCT01931670|3013571|Superiority||Odds Ratio (OR)|1.358|||<|0.088|2-Sided|97.5|0.909|2.029|||Regression, Logistic|||Month 2|
1640327|NCT01931670|3013571|Superiority||Odds Ratio (OR)|1.376|||<|0.101|2-Sided|97.5|0.89|2.127|||Regression, Logistic|||Month 1|
1640328|NCT01931670|3013571|Superiority||Odds Ratio (OR)|1.191|||<|0.376|2-Sided|97.5|0.765|1.855|||Regression, Logistic|||Month 1|
1640329|NCT01931670|3013572|Superiority||Odds Ratio (OR)|10.106|||<|0.001|2-Sided|97.5|6.434|15.874|||Regression, Logistic|||Month 6|
1640330|NCT01931670|3013572|Superiority||Odds Ratio (OR)|2.536|||<|0.001|2-Sided|97.5|1.685|3.816|||Regression, Logistic|||Month 6|
1640331|NCT01931670|3013572|Superiority||Odds Ratio (OR)|14.055|||<|0.001|2-Sided|97.5|8.716|22.664|||Regression, Logistic|||Month 5|
1640332|NCT01931670|3013572|Superiority||Odds Ratio (OR)|2.548|||<|0.001|2-Sided|97.5|1.683|3.859|||Regression, Logistic|||Month 5|
1640333|NCT01931670|3013572|Superiority||Odds Ratio (OR)|15.216|||<|0.001|2-Sided|97.5|9.429|24.554|||Regression, Logistic|||Month 4|
1640334|NCT01931670|3013572|Superiority||Odds Ratio (OR)|3.178|||<|0.001|2-Sided|97.5|2.084|4.845|||Regression, Logistic|||Month 4|
1640335|NCT01931670|3013572|Superiority||Odds Ratio (OR)|10.378|||<|0.001|2-Sided|97.5|6.615|16.282|||Regression, Logistic|||Month 2|
1640336|NCT01931670|3013572|Superiority||Odds Ratio (OR)|2.795|||<|0.001|2-Sided|97.5|1.811|4.312|||Regression, Logistic|||Month 2|
1640337|NCT01931670|3013572|Superiority||Odds Ratio (OR)|4.185|||<|0.001|2-Sided|97.5|2.707|6.469|||Regression, Logistic|||Month 1|
1640338|NCT01931670|3013572|Superiority||Odds Ratio (OR)|2.361|||<|0.001|2-Sided|97.5|1.507|3.697|||Regression, Logistic|||Month 1|
1640339|NCT01931670|3013573|Superiority||Difference in LS Mean Change|-0.08|Standard Error of the Mean|0.03||0.007|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.|
1640340|NCT01931670|3013573|Superiority||Difference in LS Mean Change|0.0|Standard Error of the Mean|0.03||0.968|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.|
1640341|NCT01931670|3013574|Superiority||Difference in LS Mean Change|-0.3|Standard Error of the Mean|0.067|<|0.001|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.|
1640342|NCT01931670|3013574|Superiority||Difference in LS Mean Change|-0.09|Standard Error of the Mean|0.067|<|0.172|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.|
1640343|NCT01931670|3013575|Superiority||Difference in LS Mean Change|-0.21|Standard Error of the Mean|0.048|<|0.001|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.|
1640344|NCT01931670|3013575|Superiority||Difference in LS Mean Change|-0.08|Standard Error of the Mean|0.048|<|0.088|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.|
1640345|NCT01931670|3013576|Superiority||Difference in LS Mean Change|-0.18|Standard Error of the Mean|0.044|<|0.001|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.|
1640346|NCT01931670|3013576|Superiority||Difference in LS Mean Change|-0.05|Standard Error of the Mean|0.044|<|0.26|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.|
1640347|NCT01931670|3013577|Superiority||Difference in LS Mean Change|-0.32|Standard Error of the Mean|0.056|<|0.001|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.|
1640564|NCT01928940|3013891|Superiority or Other||Percentage|83.0|||<|0.0001|2-Sided|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR||
1640348|NCT01931670|3013577|Superiority||Difference in LS Mean Change|-0.15|Standard Error of the Mean|0.056|<|0.009|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.|
1640349|NCT01931670|3013578|Superiority||Difference in LS Mean Change|-1.13|Standard Error of the Mean|0.074|<|0.001|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.|
1640350|NCT01931670|3013578|Superiority||Difference in LS Mean Change|-0.54|Standard Error of the Mean|0.074|<|0.001|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.|
1640351|NCT01931670|3013579|Superiority||Difference in LS Mean Change|-1.22|Standard Error of the Mean|0.156|<|0.001|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.|
1640352|NCT01931670|3013579|Superiority||Difference in LS Mean Change|-0.57|Standard Error of the Mean|0.156|<|0.001|2-Sided|||||For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.|mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.|
1640353|NCT01931670|3013580|Superiority||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic||||
1640354|NCT01931670|3013580|Superiority||||||<|0.003||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic||||
1640355|NCT01931670|3013581|Superiority||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic||||
1640356|NCT01931670|3013581|Superiority||||||<|0.001||||||An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.|Regression, Logistic||||
1640357|NCT01931566|3013584|Superiority|||||||0.307|||||||Regression, Cox||||
1640358|NCT01931566|3013585|Other|||||||0.023|||||||Regression, Cox||||
1640359|NCT01931475|3013596|Superiority or Other||Total Effect|97.49||||0.002|2-Sided||||||Regression, Linear|||Path analysis for the direct analgesic effect was used to test the null hypothesis that the change in BPI average pain severity depends on the improvement of HADS-D or HADS-A, versus the alternative that the improvement in BPI average pain severity is due to a direct analgesic effect of the treatment and not dependent upon the improvement in depression and anxiety symptoms.|
1640360|NCT01931475|3013598|Superiority or Other||Mean Difference (Final Values)|-0.06|||||2-Sided|95.0|-0.4|0.27|||||Enjoyment of life||
1640361|NCT01931475|3013598|Superiority or Other||Mean Difference (Final Values)|-0.22|||||2-Sided|95.0|-0.57|0.14|||||Sleep||
1640362|NCT01931475|3013598|Superiority or Other||Mean Difference (Final Values)|-0.07|||||2-Sided|95.0|-0.34|0.21|||||Relations with other people||
1640363|NCT01931475|3013598|Superiority or Other||Median Difference (Final Values)|-0.31|||||2-Sided|95.0|-0.68|0.06|||||Normal work (includes both work outside the home and housework)||
1640364|NCT01931475|3013598|Superiority or Other||Median Difference (Final Values)|-0.47|||||2-Sided|95.0|-0.82|-0.11|||||Walking ability||
1640365|NCT01931475|3013598|Superiority or Other||Mean Difference (Final Values)|-0.39|||||2-Sided|95.0|-0.74|-0.05|||||Mood||
1640366|NCT01931475|3013598|Superiority or Other||Mean Difference (Final Values)|-0.56|||||2-Sided|95.0|-0.94|-0.19|||||General activity||
1640367|NCT01931475|3013598|Superiority or Other||Mean Difference (Final Values)|-0.27|||||2-Sided|95.0|-0.53|-0.02|||||BPI Interference Average Score||
1640368|NCT01931475|3013599|Superiority or Other||Mean Difference (Final Values)|-0.47|||||2-Sided|95.0|-0.82|-0.11|||||BPI Severity of Right Now Pain||
1640369|NCT01931475|3013599|Superiority or Other||Mean Difference (Final Values)|-0.29|||||2-Sided|95.0|-0.6|0.03|||||BPI Severity of Least Pain||
1640370|NCT01931475|3013599|Superiority or Other||Mean Difference (Final Values)|-0.71|||||2-Sided|95.0|-1.07|-0.34|||||BPI Severity of Worst Pain||
1640371|NCT01931475|3013600|Superiority or Other||Mean Difference (Final Values)|-0.28|||||2-Sided|95.0|-0.41|-0.15|||||||
1640372|NCT01931475|3013601|Superiority or Other||Mean Difference (Final Values)|-0.39|||||2-Sided|95.0|-0.62|-0.16|||||Stiffness||
1640373|NCT01931475|3013601|Superiority or Other||Mean Difference (Final Values)|-2.36|||||2-Sided|95.0|-3.95|-0.78|||||Physical Function||
1640374|NCT01931475|3013601|Superiority or Other||Mean Difference (Final Values)|-0.71|||||2-Sided|95.0|-1.21|-0.21|||||Pain||
1640375|NCT01931475|3013601|Superiority or Other||Mean Difference (Final Values)|-3.49|||||2-Sided|95.0|-5.62|-1.35|||||Total Score||
1640376|NCT01931475|3013602|Superiority or Other||Mean Difference (Final Values)|-0.36|||||2-Sided|95.0|-0.54|-0.19|||||||
1640377|NCT01931475|3013603|Superiority or Other||Mean Difference (Final Values)|-0.5|||||2-Sided|95.0|-0.8|-0.2|||||||
1640378|NCT01930487|3013642|Superiority or Other||Mean Difference (Net)|-0.046|Standard Error of the Mean|0.017||0.0138|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640379|NCT01930487|3013643|Superiority or Other||Mean Difference (Net)|-0.005|Standard Error of the Mean|0.013||0.6941|2-Sided||||||paired t-test||dietary supplement with antioxidants – placebo||
1640380|NCT01930487|3013644|Superiority or Other||Mean Difference (Net)|-0.03|Standard Error of the Mean|0.018||0.1045|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640381|NCT01930487|3013645|Superiority or Other||Mean Difference (Net)|-0.043|Standard Error of the Mean|0.012||0.0026|2-Sided||||||paird t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640382|NCT01930487|3013646|Superiority or Other||Mean Difference (Net)|-1.0|Standard Error of the Mean|2.1||0.6382|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640383|NCT01930487|3013647|Superiority or Other||Mean Difference (Net)|1.3|Standard Error of the Mean|1.7||0.447|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640384|NCT01930487|3013648|Superiority or Other||Mean Difference (Net)|-0.01|Standard Error of the Mean|0.012||0.3738|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640385|NCT01930487|3013649|Superiority or Other||Mean Difference (Net)|-0.016|Standard Error of the Mean|0.012||0.2089|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640386|NCT01930487|3013650|Superiority or Other||Mean Difference (Net)|-0.027|Standard Error of the Mean|0.012||0.0348|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640387|NCT01930487|3013651|Superiority or Other||Mean Difference (Net)|-0.01|Standard Error of the Mean|0.01||0.3326|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640388|NCT01930487|3013652|Superiority or Other||Mean Difference (Net)|-0.021|Standard Error of the Mean|0.009||0.033|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640389|NCT01930487|3013653|Superiority or Other||Mean Difference (Net)|-0.015|Standard Error of the Mean|0.015||0.3414|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640390|NCT01930487|3013654|Superiority or Other||Mean Difference (Net)|-0.001|Standard Error of the Mean|0.01||0.9556|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640391|NCT01930487|3013655|Superiority or Other||Mean Difference (Net)|-0.003|Standard Error of the Mean|0.013||0.81|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640392|NCT01930487|3013656|Superiority or Other||Mean Difference (Net)|0.19|Standard Error of the Mean|0.09||0.0626|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640393|NCT01930487|3013657|Superiority or Other||Mean Difference (Net)|0.23|Standard Error of the Mean|0.12||0.0656|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640394|NCT01930487|3013658|Superiority or Other||Mean Difference (Net)|0.16|Standard Error of the Mean|0.09||0.0866|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640395|NCT01930487|3013659|Superiority or Other||Mean Difference (Net)|0.32|Standard Error of the Mean|0.12||0.0137|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640396|NCT01930487|3013660|Superiority or Other||Mean Difference (Net)|0.4|Standard Error of the Mean|0.07|<|0.0001|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640397|NCT01930487|3013661|Superiority or Other||Mean Difference (Net)|0.37|Standard Error of the Mean|0.13||0.0119|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640398|NCT01930487|3013662|Superiority or Other||Mean Difference (Net)|0.25|Standard Error of the Mean|0.26||0.344|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640399|NCT01930487|3013663|Superiority or Other||Mean Difference (Net)|0.78|Standard Error of the Mean|0.34||0.0323|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640400|NCT01930487|3013664|Superiority or Other||Mean Difference (Net)|0.35|Standard Error of the Mean|0.29||0.2451|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640401|NCT01930487|3013665|Superiority or Other||Mean Difference (Net)|0.56|Standard Error of the Mean|0.3||0.0805|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640402|NCT01930487|3013666|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.25||0.6938|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640403|NCT01930487|3013667|Superiority or Other||Mean Difference (Net)|1.02|Standard Error of the Mean|0.34||0.0067|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640404|NCT01930487|3013668|Superiority or Other||Mean Difference (Net)|0.92|Standard Error of the Mean|0.24||0.0009|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640405|NCT01930487|3013669|Superiority or Other||Mean Difference (Net)|1.02|Standard Error of the Mean|0.35||0.0094|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640406|NCT01930487|3013670|Superiority or Other||Mean Difference (Net)|0.8|Standard Error of the Mean|0.8||0.3347|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640407|NCT01930487|3013671|Superiority or Other||Mean Difference (Net)|2.55|Standard Error of the Mean|0.83||0.0063|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640408|NCT01930487|3013672|Superiority or Other||Mean Difference (Net)|-0.013|Standard Error of the Mean|0.008||0.1202|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640409|NCT01930487|3013673|Superiority or Other||Mean Difference (Net)|-0.019|Standard Error of the Mean|0.023||0.023|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640410|NCT01930487|3013674|Superiority or Other||Mean Difference (Net)|-0.018|Standard Error of the Mean|0.009||0.0482|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640411|NCT01930487|3013675|Superiority or Other||Mean Difference (Net)|-0.002|Standard Error of the Mean|0.008||0.8191|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640412|NCT01930487|3013676|Superiority or Other||Mean Difference (Net)|0.21|Standard Error of the Mean|0.07||0.0081|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640413|NCT01930487|3013677|Superiority or Other||Mean Difference (Net)|0.24|Standard Error of the Mean|0.07||0.0024|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1641990|NCT01884545|3018050|Superiority|||||||0.6289|||||||Regression, Linear||||
1640414|NCT01930487|3013678|Superiority or Other||Mean Difference (Net)|0.38|Standard Error of the Mean|0.07|<|0.0001|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640415|NCT01930487|3013679|Superiority or Other||Mean Difference (Net)|0.51|Standard Error of the Mean|0.21||0.0208|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640416|NCT01930487|3013680|Superiority or Other||Mean Difference (Net)|0.45|Standard Error of the Mean|0.21||0.0352|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640417|NCT01930487|3013681|Superiority or Other||Mean Difference (Net)|0.46|Standard Error of the Mean|0.23||0.0476|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants – placebo||
1640418|NCT01930487|3013682|Superiority or Other||Mean Difference (Net)|0.97|Standard Error of the Mean|0.21|<|0.0001|2-Sided||||||paired t-test, 2-sidede||dietary supplement with antioxidants - placebo||
1640419|NCT01930487|3013683|Superiority or Other||Mean Difference (Net)|1.67|Standard Error of the Mean|0.59||0.007|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo||
1640420|NCT01930487|3013684|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|1.3||0.9147|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo||
1640421|NCT01930487|3013685|Superiority or Other||Mean Difference (Net)|-0.025|Standard Error of the Mean|0.011||0.0249|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo||
1640422|NCT01930487|3013686|Superiority or Other||Mean Difference (Net)|-0.037|Standard Error of the Mean|0.011||0.0016|2-Sided||||||paired t-test, 2-sided||dietary supplement with antioxidants - placebo||
1640423|NCT01930188|3013701|Non-Inferiority or Equivalence|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 0.5 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).|treatment difference|-0.92|||<|0.0001|2-Sided|95.0|-1.21|-0.62|||Mixed Models Analysis|Analysis done with mixed model for repeated measurements (treatment & country as fixed factors & baseline value as covariate) all nested within visit|||
1640424|NCT01930188|3013701|Non-Inferiority or Equivalence|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and sitagliptin was below the pre-specified non-inferiority margin (0.3 %).|treatment difference|-1.06|||<|0.0001|2-Sided|95.0|-1.21|-0.91|||Mixed Models Analysis|Post-baseline responses analysed with mixed model for repeated measurements-treatment & country (fixed) & baseline (covariate) all nested within visit|||
1640425|NCT01930045|3013713|Superiority or Other||GMR|0.9|||||2-Sided|90.0|0.58|1.41|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator||
1640426|NCT01930045|3013713|Superiority or Other||GMR|0.9|||||2-Sided|90.0|0.58|1.4|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator||
1640427|NCT01930045|3013714|Superiority or Other||GMR|0.89|||||2-Sided|90.0|0.64|1.22|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator||
1640428|NCT01930045|3013714|Superiority or Other||GMR|0.87|||||2-Sided|90.0|0.64|1.18|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator||
1640429|NCT01930045|3013715|Superiority or Other||GMR|0.51|||||2-Sided|90.0|0.4|0.64|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4|
1640430|NCT01930045|3013715|Superiority or Other||GMR|0.5|||||2-Sided|90.0|0.39|0.65|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4|
1640431|NCT01930045|3013716|Superiority or Other||GMR|0.7|||||2-Sided|90.0|0.48|1.04|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator||
1640432|NCT01930045|3013716|Superiority or Other||GMR|0.78|||||2-Sided|90.0|0.55|1.1|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator||
1640433|NCT01930045|3013717|Superiority or Other||GMR|0.68|||||2-Sided|90.0|0.5|0.92|||||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator||
1640434|NCT01930045|3013717|Superiority or Other||GMR|0.81|||||2-Sided|90.0|0.63|1.05|||||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator||
1640435|NCT01930045|3013718|Superiority or Other||GMR|0.38||||0.624|2-Sided|90.0|0.3|0.49|||Hochberg step-up procedure||The Raltegravir followed by Maalox treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs GMR is not less than 0.4|
1640436|NCT01930045|3013718|Superiority or Other||Geometric Mean Ratio (GMR)|0.4||||0.507|2-Sided|90.0|0.31|0.52|||Hochberg step-up procedure||The Maalox followed by Raltegravir treatment group was the numerator, and the Raltegravir alone treatment group was the denominator|The hypothesis is that the true Raltegravir C 12 hrs geometric mean ratio (GMR) is not less than 0.4|
1640437|NCT01929876|3013728|Superiority or Other||Ratio of LS means|583.9|||||2-Sided|90.0|488.2|698.2|||||Ratio of LS means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent). LS means from ANOVA, calculated by transforming the natural log means back to the linear scale.||
1640438|NCT01929876|3013730|Superiority or Other||Ratio of LS means|672.3|||||2-Sided|90.0|563.7|801.9|||||Ratio of LS means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent). LS means from ANOVA, calculated by transforming the natural log means back to the linear scale.|Only participants with PK parameter data from both Period 1 Day 1 and Period 2 Day 4 (n=11) were included for statistical analyses.|
1640439|NCT01929876|3013731|Superiority or Other||Ratio of least squares means|316.6|||||2-Sided|90.0|268.1|374.0|||||LS means from analysis of variance (ANOVA), calculated by transforming the natural log means back to the linear scale (that is, geometric LS mean).|Ratio of Least squares (LS) means (Cobimetinib with Itraconazole/Cobimetinib alone) of natural log-transformed parameter (expressed as a percent).|
1640440|NCT01929863|3013733|Superiority or Other||Ratio|1.036|||||2-Sided|90.0|0.937|1.145|||||The point estimate was calculated as geometric least square mean ratio of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Cmax.||
1640441|NCT01929863|3013734|Superiority or Other||Ratio|1.013|||||2-Sided|90.0|0.912|1.125|||||The point estimate was calculated as geometric least square mean ratio of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-10 h).||
1640442|NCT01929863|3013735|Superiority or Other||Mean Difference (Net)|-34.76|||||2-Sided|95.0|-54.67|-14.85|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-24 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (0-24 h) Weighted Mean.|
1640443|NCT01929863|3013735|Superiority or Other||Mean Difference (Net)|-40.96|||||2-Sided|95.0|-66.64|-15.29|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (10-14 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (10-14 h) Weighted Mean.|
1640444|NCT01929863|3013735|Superiority or Other||Mean Difference (Net)|-32.0|||||2-Sided|95.0|-55.41|-8.58|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (4-10 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (4-10 h) Weighted Mean.|
1640445|NCT01929863|3013735|Superiority or Other||Mean Difference (Net)|-26.14|||||2-Sided|95.0|-45.8|-6.49|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for AUC (0-4 h) Weighted Mean.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for AUC (0-4 h) Weighted Mean|
1640446|NCT01929863|3013735|Superiority or Other||Mean Difference (Net)|-29.35|||||2-Sided|95.0|-50.84|-7.86|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (0-24 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (0-24 h) Value.|
1640447|NCT01929863|3013735|Superiority or Other||Mean Difference (Net)|-45.41|||||2-Sided|95.0|-72.8|-18.03|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (10-14 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (10-14 h) Value.|
1640448|NCT01929863|3013735|Superiority or Other||Mean Difference (Net)|-36.58|||||2-Sided|95.0|-62.25|-10.9|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (4-10 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (4-10 h) Value.|
1640449|NCT01929863|3013735|Superiority or Other||Mean Difference (Net)|-29.16|||||2-Sided|95.0|-51.68|-6.64|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Maximum (0-4 h) Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Maximum (0-4 h) Value.|
1640450|NCT01929863|3013735|Superiority or Other||Mean Difference (Net)|-28.13|||||2-Sided|95.0|-50.4|-5.86|||||The point estimate was calculated as least square mean difference (net values) of Treatment A-GSK2330672 + Metformin and Treatment B-Placebo + Metformin for Fasting Value.|Treatment A-GSK2330672 + Metformin versus Treatment B-Placebo + Metformin for Fasting Value.|
1640451|NCT01929681|3013760|Superiority||||||<|0.182|||||||Regression, Linear|Mixed effects analysis|||
1640452|NCT01929681|3013761|Superiority||||||<|0.444|||||||Regression, Linear|Mixed effects analysis|||
1640453|NCT01929681|3013762|Superiority||||||<|0.449|||||||Regression, Linear|Mixed effects analysis|||
1640454|NCT01929681|3013763|Superiority||||||<|0.182|||||||Regression, Linear||||
1640455|NCT01929681|3013764|Superiority||||||<|0.049|||||||Regression, Linear||||
1640456|NCT01929317|3013792|Superiority or Other||Mean Difference (Final Values)|0.85|||||2-Sided|95.0|-0.63|2.33|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 12."||
1640457|NCT01929317|3013792|Superiority or Other||Mean Difference (Final Values)|0.96|||||2-Sided|95.0|-0.47|2.39|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 8."||
1640458|NCT01929317|3013792|Superiority or Other||Mean Difference (Final Values)|0.56|||||2-Sided|95.0|-0.71|1.84|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 6."||
1640459|NCT01929317|3013792|Superiority or Other||Mean Difference (Final Values)|0.57|||||2-Sided|95.0|-0.64|1.78|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 4."||
1640460|NCT01929317|3013792|Superiority or Other||Mean Difference (Final Values)|0.19|||||2-Sided|95.0|-0.98|1.36|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On without troublesome dyskinesias for Week 2."||
1640461|NCT01929317|3013793|Superiority or Other||Mean Difference (Final Values)|0.86|||||2-Sided|95.0|-0.55|2.26|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 12."||
1640462|NCT01929317|3013793|Superiority or Other||Mean Difference (Final Values)|0.85|||||2-Sided|95.0|-0.52|2.22|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 8."||
1640463|NCT01929317|3013793|Superiority or Other||Mean Difference (Final Values)|0.6|||||2-Sided|95.0|-0.65|1.86|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 6."||
1640464|NCT01929317|3013793|Superiority or Other||Mean Difference (Final Values)|0.47|||||2-Sided|95.0|-0.75|1.7|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 4."||
1640465|NCT01929317|3013793|Superiority or Other||Mean Difference (Final Values)|0.07|||||2-Sided|95.0|-1.07|1.21|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent On for Week 2."||
1640527|NCT01929031|3013855|Superiority or Other|||||||0.0001|||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Ibuprofen|
1640466|NCT01929317|3013794|Superiority or Other||Mean Difference (Final Values)|-5.98|||||2-Sided|95.0|-15.92|3.96|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 12."||
1640467|NCT01929317|3013794|Superiority or Other||Mean Difference (Final Values)|-4.46|||||2-Sided|95.0|-14.06|5.14|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 8."||
1640468|NCT01929317|3013794|Superiority or Other||Mean Difference (Final Values)|-2.78|||||2-Sided|95.0|-12.06|6.49|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 6."||
1640469|NCT01929317|3013794|Superiority or Other||Mean Difference (Final Values)|0.14|||||2-Sided|95.0|-7.94|8.22|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 4."||
1640470|NCT01929317|3013794|Superiority or Other||Mean Difference (Final Values)|-1.03|||||2-Sided|95.0|-8.77|6.71|||||"Estimated value and CI are presented for the change from Baseline in the proportion of awake time spent Off for Week 2."||
1640471|NCT01929317|3013795|Superiority or Other||Mean Difference (Final Values)|-1.07|||||2-Sided|95.0|-2.73|0.58|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 12."||
1640472|NCT01929317|3013795|Superiority or Other||Mean Difference (Final Values)|-0.85|||||2-Sided|95.0|-2.44|0.75|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 8."||
1640473|NCT01929317|3013795|Superiority or Other||Mean Difference (Final Values)|-0.35|||||2-Sided|95.0|-1.95|1.24|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 6."||
1640474|NCT01929317|3013795|Superiority or Other||Mean Difference (Final Values)|0.05|||||2-Sided|95.0|-1.34|1.45|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 4."||
1640475|NCT01929317|3013795|Superiority or Other||Mean Difference (Final Values)|-0.3|||||2-Sided|95.0|-1.65|1.04|||||"Estimated value and CI are presented for the change from Baseline in actual hours of awake time spent Off for Week 2."||
1640476|NCT01929317|3013808|Superiority or Other||Mean Difference (Final Values)|-0.2|||||2-Sided|95.0|-0.9|0.5|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 12.||
1640477|NCT01929317|3013808|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.7|0.7|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 8.||
1640478|NCT01929317|3013808|Superiority or Other||Mean Difference (Final Values)|0.1|||||2-Sided|95.0|-0.7|0.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 6.||
1640479|NCT01929317|3013808|Superiority or Other||Mean Difference (Final Values)|-0.1|||||2-Sided|95.0|-0.7|0.6|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 4.||
1640480|NCT01929317|3013808|Superiority or Other||Mean Difference (Final Values)|-0.1|||||2-Sided|95.0|-0.7|0.4|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 4 total score for Week 2.||
1640481|NCT01929317|3013809|Superiority or Other||Mean Difference (Final Values)|-0.1|||||2-Sided|95.0|-2.2|2.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 12, Off status.||
1640482|NCT01929317|3013809|Superiority or Other||Mean Difference (Final Values)|-0.2|||||2-Sided|95.0|-2.1|1.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 8, Off status.||
1640483|NCT01929317|3013809|Superiority or Other||Mean Difference (Final Values)|-0.9|||||2-Sided|95.0|-2.8|1.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 6, Off status.||
1640484|NCT01929317|3013809|Superiority or Other||Mean Difference (Final Values)|-0.9|||||2-Sided|95.0|-2.6|0.8|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 4, Off status.||
1640485|NCT01929317|3013809|Superiority or Other||Mean Difference (Final Values)|-0.6|||||2-Sided|95.0|-1.8|0.5|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 2, Off status.||
1640486|NCT01929317|3013809|Superiority or Other||Mean Difference (Final Values)|-1.0|||||2-Sided|95.0|-2.7|0.7|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 12, On status.||
1640487|NCT01929317|3013809|Superiority or Other||Mean Difference (Final Values)|-1.2|||||2-Sided|95.0|-2.8|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 8, On status.||
1640488|NCT01929317|3013809|Superiority or Other||Mean Difference (Final Values)|-1.1|||||2-Sided|95.0|-2.6|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 6, On status.||
1640489|NCT01929317|3013809|Superiority or Other||Mean Difference (Final Values)|-1.1|||||2-Sided|95.0|-2.4|0.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 4, On status.||
1640490|NCT01929317|3013809|Superiority or Other||Mean Difference (Final Values)|-0.9|||||2-Sided|95.0|-1.8|0.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 2 total score for Week 2, On status.||
1640491|NCT01929317|3013810|Superiority or Other||Mean Difference (Final Values)|0.2|||||2-Sided|95.0|-0.2|0.6|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 12.||
1640492|NCT01929317|3013810|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.3|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 8.||
1640493|NCT01929317|3013810|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.4|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 6.||
1640494|NCT01929317|3013810|Superiority or Other||Mean Difference (Final Values)|0.1|||||2-Sided|95.0|-0.2|0.4|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 4.||
1640495|NCT01929317|3013810|Superiority or Other||Mean Difference (Final Values)|0.1|||||2-Sided|95.0|-0.2|0.3|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part 1 total score for Week 2.||
1640496|NCT01929317|3013812|Superiority or Other||Mean Difference (Final Values)|0.9|||||2-Sided|95.0|-2.0|3.9|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 12.||
1640497|NCT01929317|3013812|Superiority or Other||Mean Difference (Final Values)|-0.7|||||2-Sided|95.0|-3.4|2.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 8.||
1640498|NCT01929317|3013812|Superiority or Other||Mean Difference (Final Values)|0.3|||||2-Sided|95.0|-2.3|3.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 6.||
1640499|NCT01929317|3013812|Superiority or Other||Mean Difference (Final Values)|0.6|||||2-Sided|95.0|-1.9|3.1|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 4.||
1640500|NCT01929317|3013812|Superiority or Other||Mean Difference (Final Values)|-0.2|||||2-Sided|95.0|-2.4|2.0|||||Estimated value and CI are presented for the change from Baseline in Japanese UPDRS Part III total score for Week 2.||
1640501|NCT01929317|3013813|Superiority or Other||Mean change from Baseline|-4.8|||<|0.001|2-Sided|95.0|-6.3|-3.2|||t-test, 1 sided||||
1640502|NCT01929083|3013836|Superiority or Other|||||||0.0001|||||||t-test, 2 sided|Paired t-test|||
1640503|NCT01929083|3013837|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|Paired t-test|||
1640504|NCT01929083|3013838|Superiority or Other|||||||0.36|||||||t-test, 2 sided|Paired t-test|||
1640505|NCT01929083|3013839|Superiority or Other|||||||0.43|||||||t-test, 2 sided|Paired t-test|||
1640506|NCT01929083|3013840|Superiority or Other||||||>|0.99||||||p value for transient QTc interval > 500 ms|Fisher Exact||||
1640507|NCT01929083|3013840|Superiority or Other||||||>|0.99||||||p value for burning at infusion site|Fisher Exact||||
1640508|NCT01929083|3013840|Superiority or Other||||||>|0.65||||||p value for bradycardia|Fisher Exact||||
1640509|NCT01929083|3013841|Superiority or Other|||||||0.002|||||||t-test, 2 sided|Paired t-test|||
1640510|NCT01929083|3013842|Superiority or Other|||||||0.02|||||||t-test, 2 sided|Paired t-test|||
1640511|NCT01929083|3013843|Superiority or Other|||||||0.48||||||p value for incidence of vertigo requiring discontinuation of therapy|Fisher Exact||||
1640512|NCT01929083|3013843|Superiority or Other|||||||0.48||||||p value for incidence of hypotension|Fisher Exact||||
1640513|NCT01929083|3013843|Superiority or Other|||||||0.23||||||p value for incidence of breast tenderness|Fisher Exact||||
1640514|NCT01929083|3013843|Superiority or Other|||||||0.23||||||p value for incidence of mood changes|Fisher Exact||||
1640515|NCT01929083|3013843|Superiority or Other|||||||0.6||||||p values for incidence of headache|Fisher Exact||||
1640516|NCT01929083|3013843|Superiority or Other|||||||0.04||||||P value for incidence of fatigue/malaise|Fisher Exact||||
1640517|NCT01929083|3013844|Superiority or Other|||||||0.003|||||||t-test, 2 sided|Paired t-test|||
1640518|NCT01929083|3013845|Superiority or Other|||||||0.04|||||||t-test, 2 sided|Paired t-test|||
1640519|NCT01929044|3013848|Superiority or Other||Odds Ratio (OR)|0.64||||0.0992|2-Sided|95.0|0.37|1.09|||Regression, Logistic|A logistic regression model was used to evaluate the response with treatment as fixed effect and baseline pain intensity as continuous covariate.|Exact 95% confidence interval obtained by Clopper and Pearson approach.||
1640520|NCT01929044|3013849|Superiority or Other|||||||0.0113|||||||van Elteren test|The van Elteren test stratifying for centre (Cochran-Mantel-Haenszel test using modified ridit scores) was performed.|||
1640521|NCT01929044|3013850|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.18||0.0149|2-Sided|95.0|-0.81|-0.09|||Mixed Models Analysis|Kenward−Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.||
1640522|NCT01929044|3013851|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.2||0.022|2-Sided|95.0|-0.85|-0.07|||Mixed Models Analysis|Kenward−Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.||
1640523|NCT01929044|3013852|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.21||0.0658|2-Sided|95.0|-0.82|0.03|||Mixed Models Analysis|Kenward−Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.||
1640524|NCT01929044|3013853|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.2||0.121|2-Sided|95.0|-0.7|0.08|||Mixed Models Analysis|Kenward−Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.||
1640525|NCT01929044|3013854|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.23||0.0743|2-Sided|95.0|-0.88|0.04|||Mixed Models Analysis|Kenward−Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.||
1640526|NCT01929044|3013854|Non-Inferiority or Equivalence|One−sided test relative to the non−inferiority margin of 1|Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-0.88|0.04|||Mixed Models Analysis|Kenward−Roger approximation is used to estimate the denominator degrees of freedom. An unstructured covariance matrix is used.|REML-based repeated measures approach includes baseline pain intensity as continuous covariate, treatment, centre, time and treatment-time interaction as fixed effects. The difference was calculated as Buscopan minus 654-II.|Restricted maximum likelihood (REML) -repeated measures approach|
1640528|NCT01929031|3013855|Superiority or Other||||||<|0.0001|||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Caffeine|
1640529|NCT01929031|3013855|Superiority or Other||||||<|0.0001|||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Placebo|
1640530|NCT01929031|3013856|Superiority or Other|||||||0.2389|||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Ibuprofen|
1640531|NCT01929031|3013856|Superiority or Other||||||<|0.0001|||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Caffeine|
1640532|NCT01929031|3013856|Superiority or Other||||||<|0.0001|||||||Log Rank|Log rank test stratified for baseline pain intensity as measured on the 4-point VRS.||Ibuprofen/Caffeine vs. Placebo|
1640533|NCT01929031|3013857|Superiority or Other||Mean Difference (Final Values)|3.594|Standard Error of the Mean|0.571|<|0.0001|2-Sided|95.0|2.472|4.716|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Ibuprofen||
1640534|NCT01929031|3013857|Superiority or Other||Mean Difference (Final Values)|7.972|Standard Error of the Mean|0.808|<|0.0001|2-Sided|95.0|6.384|9.559|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Caffeine||
1640535|NCT01929031|3013857|Superiority or Other||Mean Difference (Final Values)|8.525|Standard Error of the Mean|0.808|<|0.0001|2-Sided|95.0|6.937|10.113|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Placebo||
1640536|NCT01929031|3013858|Superiority or Other||Mean Difference (Final Values)|12.126|Standard Error of the Mean|2.868|<|0.0001|2-Sided|95.0|6.493|17.759|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Ibuprofen||
1640537|NCT01929031|3013858|Superiority or Other||Mean Difference (Final Values)|36.467|Standard Error of the Mean|4.058|<|0.0001|2-Sided|95.0|28.497|44.437|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Caffeine||
1640538|NCT01929031|3013858|Superiority or Other||Mean Difference (Final Values)|41.738|Standard Error of the Mean|4.058|<|0.0001|2-Sided|95.0|33.767|49.708|||ANCOVA|The statistical model included baseline PI (VRS), and treatment.|Ibuprofen/Caffeine vs. Placebo||
1640539|NCT01929018|3013859|Superiority|||||||0.35|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.|
1640540|NCT01929018|3013859|Superiority|||||||0.96|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.|
1640541|NCT01929018|3013860|Superiority|||||||0.4|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.|
1640542|NCT01929018|3013860|Superiority|||||||0.62|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.|
1640543|NCT01929018|3013861|Superiority|||||||0.06|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.|
1640544|NCT01929018|3013861|Superiority|||||||0.03|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.|
1640545|NCT01929018|3013862|Superiority|||||||0.02|||||||t-test, 2 sided|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.|
1640546|NCT01929018|3013862|Superiority|||||||0.03|||||||t-test, 2 sided|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.|
1640547|NCT01929018|3013863|Superiority|||||||0.13|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.|
1640548|NCT01929018|3013863|Superiority|||||||0.83|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.|
1640549|NCT01929018|3013864|Superiority|||||||0.58|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.|
1640550|NCT01929018|3013864|Superiority|||||||0.27|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.|
1640551|NCT01929018|3013865|Superiority|||||||0.23|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.|
1640552|NCT01929018|3013865|Superiority|||||||0.11|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.|
1640553|NCT01929018|3013866|Superiority|||||||0.11|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.|
1640554|NCT01929018|3013866|Superiority|||||||0.75|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.|
1640555|NCT01929018|3013867|Superiority|||||||0.38|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 24-week test.|
1640556|NCT01929018|3013867|Superiority|||||||0.87|||||||Mixed Models Analysis|||Test null hypothesis that there is no difference between groups from baseline to 12-week test.|
1640557|NCT01928940|3013882|Superiority or Other||Percentage|83.0|||<|0.0001|2-Sided|95.0|35.9|99.6|||Exact binomial test||BICR Assessed ORR||
1640558|NCT01928940|3013882|Superiority or Other||Percentage|83.0|||<|0.0001|2-Sided|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR||
1640559|NCT01928940|3013885|Superiority or Other||Percentage|50.0||||0.0158|2-Sided|95.0|11.8|88.2|||Exact binomial test||BICR Assessed ORR||
1640560|NCT01928940|3013885|Superiority or Other||Percentage|83.0|||<|0.0001|2-Sided|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR||
1640561|NCT01928940|3013886|Superiority or Other||Percentage|50.0||||0.0158|2-Sided|95.0|11.8|82.2|||Exact binomial test||BICR Assessed ORR||
1640562|NCT01928940|3013886|Superiority or Other||Percentage|83.0|||<|0.0001|2-Sided|95.0|35.9|99.6|||Exact binomial test||For Investigator Assessed ORR||
1640563|NCT01928940|3013891|Superiority or Other||Percentage|83.0|||<|0.0001|2-Sided|95.0|35.9|99.6|||Exact binomial test||BICR Assessed ORR||
1641174|NCT01910402|3015778|Superiority or Other (legacy)||||||<|0.016||||||Week 4|Wilcoxon (Mann-Whitney)||||
1640565|NCT01928927|3013965|Superiority||Theta statistic|0.57||||0.61|2-Sided|95.0|0.31|0.83||No adjustment for multiple comparisons|Theta statistic; DeLong & Clarke-Pearson||The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is <= a randomly selected outcome from the control arm.|Null hypothesis: theta = 0.50|
1640566|NCT01928927|3013966|Superiority||Theta statistic|0.5||||0.97|2-Sided|95.0|0.26|0.73||No adjustment for multiple comparisons|Theta statistic; DeLong & Clarke-Pearson||The theta statistic estimates the probability that a randomly selected outcome from the telmisartan arm is <= a randomly selected outcome from the control arm.|Null hypothesis: theta = 0.50|
1640567|NCT01928862|3013972|Other||Treatment Difference|-4.5|||||2-Sided|90.0|-33.5|26.3||||||CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.|
1640568|NCT01928862|3013972|Other||Treatment Difference|6.3|||||2-Sided|90.0|-25.3|36.9||||||CI of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.|
1640569|NCT01928862|3013972|Other||Treatment difference|-31.3|||||2-Sided|90.0|-58.8|0.8||||||Confidence interval (CI) of the difference in proportions between each Prepopik® group and PEG within each age group was calculated using the Clopper-Pearson method.|
1640570|NCT01928849|3013974|Other|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Comparison of RASS postoperative hours 24-48|
1640571|NCT01928849|3013974|Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of RASS postoperative hours 0-24|
1640572|NCT01928849|3013975|Other|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Comparison of DVPRS supplemental question sum|
1640573|NCT01928849|3013975|Other|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Comparison of DVPRS numeric pain score|
1640574|NCT01928849|3013976|Other|||||||0.35|||||||Wilcoxon (Mann-Whitney)||||
1640575|NCT01928849|3013977|Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Comparison of BPI Interference question sum|
1640576|NCT01928849|3013977|Other|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Comparison of BPI average pain score|
1640577|NCT01928849|3013978|Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of opioid consumption postoperative hours 24-48|
1640578|NCT01928849|3013978|Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Comparison of opioid consumption postoperative hours 0-24|
1640579|NCT01928849|3013979|Other|||||||0.74|||||||Chi-squared|||Comparison of rate of Phantom limb pain between treatment groups|
1640580|NCT01928849|3013979|Other|||||||0.95|||||||Chi-squared|||Comparison of rate of residual limb pain between treatment groups|
1640581|NCT01928849|3013980|Other||Odds Ratio (OR)|0.77||||0.53|2-Sided|95.0|0.34|1.74|||Regression, Logistic|Univariable Logistic regression|||
1640582|NCT01928797|3013982|Superiority|||||||0.33|||||||Chi-squared||||
1640583|NCT01928797|3013983|Superiority|||||||0.37|||||||Chi-squared||||
1640584|NCT01928771|3013989|Superiority or Other||Mean Difference (Final Values)|0.3||||0.004|2-Sided|95.0|0.1|0.5|||Mixed Models Analysis|Model includes covariates treatment, baseline AQLQ(S)+12 score, region, use of OCS, visit, and visit by treatment|||
1640585|NCT01928771|3013989|Superiority or Other||Mean Difference (Final Values)|0.18||||0.081|2-Sided|95.0|-0.02|0.37|||Mixed Models Analysis|Model includes covariates treatment, baseline AQLQ(S)+12 score, region, use of OCS, visit, and visit by treatment|||
1640586|NCT01928771|3013993|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.107|2-Sided|95.0|-0.48|0.05|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment|||
1640587|NCT01928771|3013993|Superiority or Other||Mean Difference (Final Values)|0.0||||0.99|2-Sided|95.0|-0.27|0.27|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment|||
1640588|NCT01928771|3013994|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.003|2-Sided|95.0|-0.48|-0.1|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment|||
1640589|NCT01928771|3013994|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.111|2-Sided|95.0|-0.34|0.04|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit and visit by treatment|||
1640590|NCT01928771|3013995|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.012|2-Sided|95.0|-0.11|-0.01|||Mixed Models Analysis|Model includes treatment, baseline proportion of nights with nocturnal awakenings, region, use of OCS, visit and visit by treatment|||
1640591|NCT01928771|3013995|Superiority or Other||Mean Difference (Final Values)|0.0||||0.964|2-Sided|95.0|-0.05|0.04|||Mixed Models Analysis|Model includes treatment, baseline proportion of nights with nocturnal awakenings, region, use of OCS, visit and visit by treatment|||
1640592|NCT01928771|3013996|Superiority or Other||Mean Difference (Final Values)|19.18||||0.008|2-Sided|95.0|5.09|33.28|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit and visit by treatment||Evening PEF change from baseline to Week 48|
1640593|NCT01928771|3013996|Superiority or Other||Mean Difference (Final Values)|21.75||||0.002|2-Sided|95.0|7.86|35.65|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit and visit by treatment||Evening PEF change from baseline to Week 48|
1640594|NCT01928771|3013997|Superiority or Other||Mean Difference (Final Values)|16.46||||0.025|2-Sided|95.0|2.08|30.83|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit and visit by treatment||Morning PEF change from baseline to Week 48|
1640595|NCT01928771|3013997|Superiority or Other||Mean Difference (Final Values)|23.32||||0.001|2-Sided|95.0|9.2|37.43|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit and visit by treatment||Morning PEF change from baseline to Week 48|
1640596|NCT01928771|3013998|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.081|2-Sided|95.0|-1.21|0.07|||Mixed Models Analysis|Model includes treatment, baseline asthma medication use, region, use of OCS, visit and visit by treatment|||
1640597|NCT01928771|3013998|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.1|2-Sided|95.0|-1.16|0.1|||Mixed Models Analysis|Model includes treatment, baseline asthma medication use, region, use of OCS, visit and visit by treatment|||
1640649|NCT01927419|3014215|Superiority or Other (legacy)||Hazard Ratio (HR)|0.38|||<|0.0001|2-Sided|95.0|0.23|0.63|||Log Rank||All randomized participants||
1640598|NCT01928771|3013999|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.043|2-Sided|95.0|-0.57|-0.01|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment|||
1640599|NCT01928771|3013999|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.169|2-Sided|95.0|-0.48|0.08|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment|||
1640600|NCT01928771|3014000|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.012|2-Sided|95.0|-0.45|-0.06|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment|||
1640601|NCT01928771|3014000|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.442|2-Sided|95.0|-0.27|0.12|||Mixed Models Analysis|Model includes treatment, baseline asthma symptom score, region, use of OCS, visit and visit by treatment|||
1640602|NCT01928771|3014001|Superiority or Other||Mean Difference (Final Values)|0.102||||0.057|2-Sided|95.0|-0.003|0.208|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit|||
1640603|NCT01928771|3014001|Superiority or Other||Mean Difference (Final Values)|-0.025||||0.644|2-Sided|95.0|-0.134|0.083|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit|||
1640604|NCT01928771|3014002|Superiority or Other||Mean Difference (Final Values)|0.159||||0.001|2-Sided|95.0|0.068|0.249|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit|||
1640605|NCT01928771|3014002|Superiority or Other||Mean Difference (Final Values)|0.106||||0.022|2-Sided|95.0|0.016|0.196|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit and treatment by visit|||
1640606|NCT01928771|3014003|Superiority or Other||Hazard Ratio (HR)|0.6|||<|0.001|2-Sided|95.0|0.46|0.78|||Regression, Cox|Model includes treatment, number of exacerbations from the previous year, region, use of OCS||Time to first exacerbation|
1640607|NCT01928771|3014003|Superiority or Other||Hazard Ratio (HR)|0.63|||<|0.001|2-Sided|95.0|0.49|0.82|||Regression, Cox|Model includes treatment, number of exacerbations in the previous year, region, use of OCS||Time to first exacerbation|
1640608|NCT01928771|3014004|Superiority or Other||Odds Ratio (OR)|0.62||||0.01|2-Sided|95.0|0.43|0.9|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations from the previous year, use of OCS||Proportion of patients with >=1 asthma exacerbation|
1640609|NCT01928771|3014004|Superiority or Other||Odds Ratio (OR)|0.54|||<|0.001|2-Sided|95.0|0.37|0.78|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with >=1 asthma exacerbation|
1640610|NCT01928771|3014005|Superiority or Other||Rate ratio|0.37|||<|0.001|2-Sided|95.0|0.2|0.67|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations resulting in ER/hospitalization in the previous year, and use of OCS|||
1640611|NCT01928771|3014005|Superiority or Other||Rate ratio|0.61|||<|0.053|2-Sided|95.0|0.37|1.01|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations resulting in ER/hospitalization in the previous year, and use of OCS|||
1640612|NCT01928771|3014006|Superiority or Other||Rate ratio|0.83||||0.268|2-Sided|95.0|0.59|1.16|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids|||
1640613|NCT01928771|3014006|Superiority or Other||Rate ratio|0.7||||0.047|2-Sided|95.0|0.5|1.0|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids|||
1640614|NCT01928771|3014007|Superiority or Other||Rate ratio|0.49|||<|0.001|2-Sided|95.0|0.37|0.64|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids|||
1640615|NCT01928771|3014007|Superiority or Other||Rate ratio|0.55|||<|0.001|2-Sided|95.0|0.42|0.71|||Negative binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids|||
1640616|NCT01928758|3014010|Other||Mean Difference (Final Values)|-0.31||||0.65|2-Sided|95.0|-1.68|1.05||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group||
1640617|NCT01928758|3014011|Other||Mean Difference (Final Values)|0.38||||0.67|2-Sided|95.0|-1.4|2.16||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.||
1640618|NCT01928758|3014012|Other||Mean Difference (Final Values)|0.69||||0.16|2-Sided|95.0|-0.28|1.65||Complete case analysis|Regression, Linear|Model was adjusted for baseline score after smoking usual nicotine content cigarettes for 2 weeks|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group||
1640619|NCT01928758|3014013|Other||Mean Difference (Final Values)|-175.7|||<|0.0001|2-Sided|95.0|-218.3|-133.1||Complete case analysis|Regression, Linear|Model was adjusted for baseline cotinine after smoking usual nicotine content cigarettes for 2-weeks.|The direction of comparison is reduced nicotine content vs. usual nicotine content cigarette treatment group.||
1640620|NCT01928719|3014014|Other||Least Squares Mean Difference|-0.16||||0.4191|2-Sided|95.0|-0.56|0.23|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.||
1640621|NCT01928719|3014015|Other||Least Squares Mean Difference|1.81||||0.0207|2-Sided|95.0|0.28|3.33|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.||
1640622|NCT01928719|3014016|Other||Least Squares Mean Difference|-4.03||||0.0305|2-Sided|95.0|-7.68|-0.38|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.||
1640648|NCT01927419|3014215|Superiority or Other (legacy)||Hazard Ratio (HR)|0.4|||<|0.0012|2-Sided|95.0|0.22|0.71|||Log Rank||All randomized BRAF WT participants||
1640623|NCT01928719|3014017|Other||Least Squares Mean Difference|-136.7|||<|0.0001|2-Sided|95.0|-171.7|-101.7|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.||
1640624|NCT01928719|3014018|Other||Least Squares Mean Difference|-4.1||||0.0006|2-Sided|95.0|-6.44|-1.75|||Mixed Models Analysis|The model included time, group, and time-by-group interaction; treating baseline scores for outcomes as covariates|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.||
1640625|NCT01928719|3014019|Other||Hazard Ratio (HR)|0.31||||0.011|2-Sided|95.0|0.13|0.77||Testing the effect of BMI Obese group (>=30) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Obese (>=30) to Underweight (<18.5) group.|The reference group is BMI Underweight group (<18.5)|
1640626|NCT01928719|3014019|Other||Hazard Ratio (HR)|0.35||||0.034|2-Sided|95.0|0.13|0.92||Testing the effect of BMI Overweight group (>=25 & < 30) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Overweight (>=25 & < 30) to Underweight (<18.5) group.|The reference group is BMI Underweight group (<18.5)|
1640627|NCT01928719|3014019|Other||Hazard Ratio (HR)|0.25||||0.006|2-Sided|95.0|0.1|0.67||Testing the effect of BMI Normal Weight group (>=18.5 & <25) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and Age.|The direction of comparison is Normal Weight (>=18.5 & <25) to Underweight (<18.5) group.|The reference group is BMI Underweight (<18.5)|
1640628|NCT01928719|3014019|Other||Hazard Ratio (HR)|1.6||||0.1|2-Sided|95.0|0.92|2.66||Testing the effect of working status in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Age, and BMI.||The reference group is not currently working.|The direction of comparison is currently working to not currently working.
1640629|NCT01928719|3014019|Other||Hazard Ratio (HR)|0.39||||0.1|2-Sided|95.0|0.13|1.18||Testing the effect of age group (Ages 60-65) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 60-65 to the Age group 18-29.|The reference group is Age equals 18-29.|
1640630|NCT01928719|3014019|Other||Hazard Ratio (HR)|0.33|||<|0.002|2-Sided|95.0|0.16|0.65||Testing the effect of age group (Ages 50-59) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 50-59 to Age group 18-29.|The reference group is Age equals 18-29.|
1640631|NCT01928719|3014019|Other||Hazard Ratio (HR)|0.33|||<|0.002|2-Sided|95.0|0.17|0.66||Testing the effect of age group (ages 40-49) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 40-49 to the Age group 18-29.|The reference group is Age equals 18-29.|
1640632|NCT01928719|3014019|Other||Hazard Ratio (HR)|0.51|||<|0.06|2-Sided|95.0|0.26|1.03||Testing the effect of age group (ages 30-39) in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Treatment Group, Working Status, and BMI.|The direction of comparison is Age group 30-39 to the Age group 18-29.|The reference group is Age equals 18-29.|
1640633|NCT01928719|3014019|Other||Hazard Ratio (HR)|3.4|||<|0.0001|2-Sided|95.0|1.99|5.81||Testing the effect of treatment group in a Multivariable Cox Regression Model.|Regression, Cox|Adjusting for Age Group, Working Status, and BMI.|The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.|The reference group is Same Nicotine Content Group.|
1640634|NCT01928719|3014020|Other||Hazard Ratio (HR)|3.3|||<|0.0001|2-Sided|95.0|1.95|5.58|||Regression, Cox||The direction of comparison is reduced nicotine content vs. same nicotine content cigarettes.||
1640635|NCT01928394|3014079|Superiority||Odds Ratio (OR)|2.12||||0.0309|2-Sided|95.0|1.06|4.26|||Cochran-Mantel-Haenszel|||SCLC Arm N Expansion as compare to SCLC Arm N-I Dose Level 2- Expansion|
1640636|NCT01928381|3014080|Superiority or Other||Mean Difference (Net)|0.11|Standard Error of the Mean|0.25||0.661|2-Sided|95.0|-0.62|0.4|||Mixed Models Analysis||||
1640637|NCT01928381|3014080|Superiority or Other||Mean Difference (Net)|-0.42|Standard Error of the Mean|0.25||0.0978|2-Sided|95.0|-0.93|0.08|||Mixed Models Analysis||In direction of Pregabain, positive control||
1640638|NCT01928381|3014080|Superiority or Other||Mean Difference (Net)|0.31|Standard Error of the Mean|0.25||0.2237|2-Sided|95.0|-0.2|0.82|||Mixed Models Analysis||In direction of Pregabalin||
1640639|NCT01928381|3014081|Superiority or Other||Mean Difference (Net)|0.17|Standard Error of the Mean|0.23||0.4822|2-Sided|95.0|-0.3|0.64|||Mixed Models Analysis||||
1640640|NCT01928381|3014081|Superiority or Other||Mean Difference (Net)|0.03|Standard Error of the Mean|0.23||0.8905|2-Sided|95.0|-0.43|0.49|||Mixed Models Analysis||||
1640641|NCT01928381|3014081|Superiority or Other||Mean Difference (Net)|0.13|Standard Error of the Mean|0.23||0.5695|2-Sided|95.0|-0.34|0.61|||Mixed Models Analysis||||
1640642|NCT01928329|3014082|Superiority||Z score|-1.312||||0.189|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1640643|NCT01928329|3014083|Superiority||Z score|-0.801||||0.423|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1640644|NCT01928329|3014084|Superiority||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.13||0.912|2-Sided|95.0|-0.28|0.25||The <0.05 is the apriori threshold for statistical significance.|Mixed Models Analysis|HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).|||
1640645|NCT01928329|3014085|Superiority||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.13||0.0816|2-Sided|95.0|-0.5|0.03||The <0.05 is the apriori threshold for statistical significance.|Mixed Models Analysis|HbA1c Linear Mixed Model Results (adjusts the model for: baseline BMI, gender, study site, race (White/Non White) and Baseline C-Peptide production).|||
1640646|NCT01928186|3014105|Other|||||||0.51|||||||Fisher Exact|the mid-P adjustment to Fisher's exact test||Association between response assessed by Ki-67 protein staining (i.e. < 10% positive cells in the surgical sample) and by the influx constant Ki decline (i.e. 30 % or larger decline between the baseline and post-therapy FLT PET) was analyzed using the mid-P adjustment to Fisher's exact test.|
1640647|NCT01927861|3014191|Other||Treatment difference|0.63|||<|0.0001|2-Sided|95.0|0.38|0.88|||ANCOVA|||The change from baseline (week 0) in the height SDS after 104 weeks of treatment was analysed using an ANCOVA model with treatment as a fixed effect and baseline height SDS as a covariate.|
1640650|NCT01927419|3014216|Superiority or Other (legacy)||Odds Ratio (OR)|15.08|||<|0.0001|2-Sided|95.0|4.85|46.93|||Cochran-Mantel-Haenszel||All randomized participants||
1640651|NCT01927419|3014217|Superiority or Other (legacy)||Odds Ratio (OR)|12.23|||<|0.0001|2-Sided|95.0|3.69|51.4|||Fisher Exact||||
1640652|NCT01926782|3014244|Superiority or Other||LS Mean Difference|2.7||||0.0306|2-Sided|97.5|-0.1|5.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis||Alirocumab 300 mg vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640653|NCT01926782|3014245|Superiority or Other||LS Mean Difference|6.6|||<|0.0001|2-Sided|97.5|3.0|10.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640654|NCT01926782|3014246|Superiority or Other||Adjusted Mean Difference|-13.6|||<|0.0001|2-Sided|97.5|-20.3|-6.9||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1640655|NCT01926782|3014247|Superiority or Other||Adjusted Mean Difference|-14.1||||0.0004|2-Sided|97.5|-22.9|-5.2||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1640656|NCT01926782|3014248|Superiority or Other||Adjusted Mean Difference|-15.1|||<|0.0001|2-Sided|97.5|-21.5|-8.6||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1640657|NCT01926782|3014249|Superiority or Other||Adjusted Mean Difference|-11.9||||0.0042|2-Sided|97.5|-21.3|-2.6||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1640658|NCT01926782|3014250|Superiority or Other||LS Mean Difference|5.2||||0.0007|2-Sided|97.5|1.8|8.7||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640659|NCT01926782|3014251|Superiority or Other||LS Mean Difference|6.9||||0.0004|2-Sided|97.5|2.6|11.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant)|
1640660|NCT01926782|3014252|Superiority or Other||LS Mean Difference|5.1||||0.0004|2-Sided|97.5|1.9|8.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640661|NCT01926782|3014253|Superiority or Other||LS Mean Difference|7.8||||0.0003|2-Sided|97.5|3.1|12.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640662|NCT01926782|3014254|Superiority or Other||Adjusted Mean Difference|-26.6|||<|0.0001|2-Sided|97.5|-32.8|-20.4||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1640663|NCT01926782|3014255|Superiority or Other||Adjusted Mean Difference|-23.5|||<|0.0001|2-Sided|97.5|-32.4|-14.5||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1640664|NCT01926782|3014256|Superiority or Other||Adjusted Mean Difference|-29.1|||<|0.0001|2-Sided|97.5|-35.5|-22.7||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1640665|NCT01926782|3014257|Superiority or Other||Adjusted Mean Difference|-27.7|||<|0.0001|2-Sided|97.5|-37.0|-18.3||Threshold for significance ≤ 0.025.|Regression, Robust|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1640666|NCT01926782|3014258|Superiority or Other||Odds Ratio (OR)|77.7|||<|0.0001|2-Sided|97.5|34.1|176.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.|
1640667|NCT01926782|3014259|Superiority or Other||Odds Ratio (OR)|297.1|||<|0.0001|2-Sided|97.5|27.9|3160.6||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.|
1640668|NCT01926782|3014260|Superiority or Other||Odds Ratio (OR)|49.5|||<|0.0001|2-Sided|97.5|23.4|104.4||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.|
1640669|NCT01926782|3014261|Superiority or Other||Odds Ratio (OR)|90.6|||<|0.0001|2-Sided|97.5|16.5|498.3||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.|
1640811|NCT01922050|3014864|Superiority||Ratio of clearance rates|1.06||||0.73|2-Sided|95.0|0.76|1.47|||Log binomial regression||||
1641991|NCT01884545|3018051|Superiority|||||||0.207|||||||Regression, Linear||||
1640670|NCT01926782|3014262|Superiority or Other||Odds Ratio (OR)|41.3|||<|0.0001|2-Sided|97.5|20.3|83.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model|
1640671|NCT01926782|3014263|Superiority or Other||Odds Ratio (OR)|280.2|||<|0.0001|2-Sided|97.5|56.7|1385.7||Threshold for significance ≤ 0.025.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640672|NCT01926782|3014264|Superiority or Other||Odds Ratio (OR)|25.6|||<|0.0001|2-Sided|97.5|13.7|47.8||Threshold for significance ≤ 0.025.|Regression, Logistic|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used multiple imputation approach followed by logistic regression model.|
1640673|NCT01926782|3014265|Superiority or Other||Odds Ratio (OR)|68.0|||<|0.0001|2-Sided|97.5|20.9|221.0||Threshold for significance ≤ 0.025.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Statistical analysis used a multiple imputation approach followed by logistic regression model.|
1640674|NCT01926782|3014266|Superiority or Other||LS Mean Difference|-32.8|||<|0.0001|2-Sided|97.5|-36.5|-29.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640675|NCT01926782|3014267|Superiority or Other||LS Mean Difference|-36.4|||<|0.0001|2-Sided|97.5|-40.4|-32.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640676|NCT01926782|3014268|Superiority or Other||LS Mean Difference|-47.1|||<|0.0001|2-Sided|97.5|-52.2|-42.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640677|NCT01926782|3014269|Superiority or Other||LS Mean Difference|-49.5|||<|0.0001|2-Sided|97.5|-54.5|-44.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640678|NCT01926782|3014270|Superiority or Other||LS Mean Difference|-44.8|||<|0.0001|2-Sided|97.5|-49.7|-39.9||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640679|NCT01926782|3014271|Superiority or Other||LS Mean Difference|-44.1|||<|0.0001|2-Sided|97.5|-49.0|-39.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640680|NCT01926782|3014272|Superiority or Other||LS Mean Difference|-35.0|||<|0.0001|2-Sided|97.5|-38.9|-31.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640681|NCT01926782|3014273|Superiority or Other||LS Mean Difference|-31.4|||<|0.0001|2-Sided|97.5|-36.6|-26.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640682|NCT01926782|3014274|Superiority or Other||LS Mean Difference|-52.8|||<|0.0001|2-Sided|97.5|-57.6|-47.9||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640683|NCT01926782|3014275|Superiority or Other||LS Mean Difference|-49.0|||<|0.0001|2-Sided|97.5|-54.8|-43.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640684|NCT01926782|3014276|Superiority or Other||LS Mean Difference|-50.0|||<|0.0001|2-Sided|97.5|-55.3|-44.8||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640685|NCT01926782|3014277|Superiority or Other||LS Mean Difference|-43.0|||<|0.0001|2-Sided|97.5|-49.9|-36.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640686|NCT01926782|3014278|Superiority or Other||LS Mean Difference|-50.3|||<|0.0001|2-Sided|97.5|-55.0|-45.6||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640687|NCT01926782|3014279|Superiority or Other||LS Mean Difference|-44.5|||<|0.0001|2-Sided|97.5|-49.9|-39.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640688|NCT01926782|3014280|Superiority or Other||LS Mean Difference|-48.2|||<|0.0001|2-Sided|97.5|-53.2|-43.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640689|NCT01926782|3014281|Superiority or Other||LS Mean Difference|-39.5|||<|0.0001|2-Sided|97.5|-45.8|-33.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640690|NCT01926782|3014282|Superiority or Other||LS Mean Difference|-59.4|||<|0.0001|2-Sided|97.5|-64.8|-54.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640691|NCT01926782|3014283|Superiority or Other||LS Mean Difference|-59.5|||<|0.0001|2-Sided|97.5|-65.0|-54.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640692|NCT01926782|3014284|Superiority or Other||LS Mean Difference|-56.3|||<|0.0001|2-Sided|97.5|-62.3|-50.3||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640693|NCT01926782|3014285|Superiority or Other||LS Mean Difference|-58.7|||<|0.0001|2-Sided|97.5|-64.5|-53.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640694|NCT01926782|3014286|Superiority or Other||LS Mean Difference|-62.0|||<|0.0001|2-Sided|97.5|-67.7|-56.2||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1640695|NCT01926782|3014287|Superiority or Other||LS Mean Difference|-59.0|||<|0.0001|2-Sided|97.5|-64.6|-53.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.|
1640696|NCT01926782|3014288|Superiority or Other|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-65.0|||<|0.0001|2-Sided|97.5|-70.4|-59.5||Threshold for significance ≤ 0.025|Mixed Models Analysis|||Week 21-24|
1640697|NCT01926782|3014288|Superiority or Other|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-58.7|||<|0.0001|2-Sided|97.5|-65.0|-52.4||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||At Week 24|
1640698|NCT01926782|3014289|Superiority or Other|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-55.2|||<|0.0001|2-Sided|97.5|-62.3|-48.1||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||Week 21-24|
1640699|NCT01926782|3014289|Superiority or Other|Alirocumab 300 mg group was compared to placebo group using an appropriate contrast statement.|LS Mean Difference|-52.4|||<|0.0001|2-Sided|97.5|-59.8|-45.0||Threshold for significance ≤ 0.025.|Mixed Models Analysis|||At Week 24|
1640700|NCT01926444|3014306|Other|||||||0.047|||||||Chi-squared||||
1640701|NCT01926444|3014307|Other|||||||0.047|||||||Chi-squared|||Time to Caecum|
1640702|NCT01926444|3014308|Other|||||||0.219|||||||ANOVA|||AUC LOCF (Standardized)- PP Population|
1640703|NCT01926444|3014308|Other|||||||0.234|||||||ANOVA|||AUC Censored (Standardized)- PP Population|
1640704|NCT01926444|3014308|Other|||||||0.299|||||||ANOVA|||AUC LOCF (standardized); FAS|
1640705|NCT01926444|3014308|Other|||||||0.506|||||||ANOVA|||AUC- censorsed (standardized); FAS|
1640706|NCT01926028|3014324|Equivalence|The proportion of patients in each group was summarized with point estimates and their 95% confidence interval|Cox Proportional Hazard|0.55||||0.1|2-Sided|95.0|0.27|1.13|||Wilcoxon (Mann-Whitney)||||
1640707|NCT01926028|3014325|Equivalence|The proportion of patients in each group was summarized with point estimates and their 95% confidence interval|Cox Proportional Hazard|0.39||||0.03|2-Sided|95.0|0.17|0.91|||Wilcoxon (Mann-Whitney)||||
1640708|NCT01926015|3014339|Non-Inferiority or Equivalence|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10|Difference in percentage|0.0|||<|0.001|2-Sided|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 3 NA >=8|
1640709|NCT01926015|3014339|Non-Inferiority or Equivalence|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10|Difference in percentage|0.0|||<|0.001|2-Sided|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 2 NA >=8|
1640710|NCT01926015|3014339|Non-Inferiority or Equivalence|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10|Difference in percentage|0.0|||<|0.001|2-Sided|95.0|-3.99|3.95|||Miettinen and Nurminen|||Poliovirus Type 1 NA >=8|
1640711|NCT01926015|3014339|Non-Inferiority or Equivalence|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10|Difference in percentage|0.0|||<|0.001|2-Sided|95.0|-3.99|3.95|||Miettinen and Nurminen|||Pertussis FHA >=10 EU/mL|
1640712|NCT01926015|3014339|Non-Inferiority or Equivalence|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10|Difference in percentage|0.0|||<|0.001|2-Sided|95.0|-3.99|3.95|||Miettinen and Nurminen|||Pertussis Toxin >=10 EU/mL|
1640713|NCT01926015|3014339|Non-Inferiority or Equivalence|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10|Difference in percentage|0.0|||<|0.001|2-Sided|95.0|-3.99|3.95|||Miettinen and Nurminen|||Tetanus Toxin >=0.01 IU/mL|
1640714|NCT01926015|3014339|Non-Inferiority or Equivalence|Non-inferiority requires that the lower bound of the 95% confidence interval of the percentage difference, excluding a difference >=10%, is >=-0.10|Difference in percentage|0.0|||<|0.001|2-Sided|95.0|-3.99|3.95|||Miettinen and Nurminen|||Diphtheria Toxin >=0.1 IU/mL|
1640715|NCT01925768|3014357|Superiority or Other (legacy)||Adjusted Difference|18.6||||0.004|2-Sided|95.0|6.5|30.7||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 20; 2-sided 95% CI is based on a normal approximation to the weighted average|
1640716|NCT01925768|3014357|Superiority or Other (legacy)||Adjusted Difference|11.0||||0.0884|2-Sided|95.0|-1.3|23.2||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 12; 2-sided 95% CI is based on a normal approximation to the weighted average|
1640812|NCT01922050|3014864|Superiority||Ratio of clearance rates|2.1|||<|0.001|2-Sided|95.0|1.35|3.25|||Log binomial regression||||
1640717|NCT01925768|3014357|Superiority or Other (legacy)||Adjusted Difference|12.7||||0.0392|2-Sided|95.0|0.8|24.6||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 8; 2-sided 95% CI is based on a normal approximation to the weighted average|
1640718|NCT01925768|3014357|Superiority or Other (legacy)||Adjusted Difference|17.8||||0.0036|2-Sided|95.0|6.2|29.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 6; 2-sided 95% CI is based on a normal approximation to the weighted average|
1640719|NCT01925768|3014357|Superiority or Other (legacy)||Adjusted Difference|8.6||||0.1121|2-Sided|95.0|-1.7|18.9||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 4; 2-sided 95% CI is based on a normal approximation to the weighted average|
1640720|NCT01925768|3014357|Superiority or Other (legacy)||Adjusted Difference|9.7||||0.0252|2-Sided|95.0|1.6|17.7||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights|Week 2; 2-sided 95% CI is based on a normal approximation to the weighted average|
1640721|NCT01925768|3014358|Superiority or Other (legacy)||Adjusted Difference|20.7||||0.0015|2-Sided|95.0|8.5|32.8||2 sided-p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights||
1640722|NCT01925768|3014359|Superiority or Other (legacy)||Hodges-Lehmann|10.0||||0.0168|2-Sided|95.0|0.0|20.0|||Stratified Van Elteren test|p-value based on stratified Van Elteren test, using 2 stratification factors: previous DMARD use and baseline Oral Corticosteroids|Location shift and 95% CI based on Hodges-Lehmann for between treatment median estimates.||
1640723|NCT01925768|3014360|Superiority or Other (legacy)||LS Mean Difference|3.46||||0.0039|2-Sided|95.0|1.13|5.8|||Mixed Models Analysis||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights||
1640724|NCT01925768|3014361|Superiority or Other (legacy)||LS Mean Difference|-0.68|||<|0.0001|2-Sided|95.0|-1.0|-0.35|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate||
1640725|NCT01925768|3014362|Superiority or Other (legacy)||LS Mean Difference|-0.15||||0.0229|2-Sided|95.0|-0.279|-0.021|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate||
1640726|NCT01925768|3014363|Superiority or Other (legacy)||Adjusted Difference|19.7||||0.0016|2-Sided|95.0|8.0|31.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline oral corticosteroids (prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.||
1640727|NCT01925768|3014364|Superiority or Other (legacy)||Mean Difference (Final Values)|-10.0||||0.012|2-Sided|95.0|-21.5|10.2|||Sign test|p-value based on distribution free signed rank test|||
1640728|NCT01925768|3014365|Superiority or Other (legacy)||LS Mean Difference|3.4||||0.0039|2-Sided|95.0|1.1|5.7||Based on an MMRM model for the change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD use and baseline Oral Corticosteroids use as factors and the baseline value as a covariate.|Mixed Models Analysis|||2-sided 95% CI for the difference in LS mean.|
1640729|NCT01925768|3014366|Superiority or Other (legacy)||LS Mean Difference|2.68||||0.0167|2-Sided|95.0|0.49|4.88|||Mixed Models Analysis|Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)|The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate||
1640730|NCT01925768|3014367|Superiority or Other (legacy)||LS Mean Difference|-0.5||||0.0051|2-Sided|95.0|-0.85|-0.15|||Mixed Models Analysis||The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate.||
1640731|NCT01925768|3014368|Superiority or Other (legacy)||Adjusted Difference|18.5||||0.004|2-Sided|95.0|6.3|30.6||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel|Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders.|Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.||
1640813|NCT01922050|3014864|Superiority||Ratio of clearance rates|1.79|||<|0.013|2-Sided|95.0|1.13|2.84|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.|
1641992|NCT01884545|3018051|Superiority|||||||0.1466|||||||Regression, Linear||||
1640732|NCT01925768|3014369|Superiority or Other (legacy)||LS Mean Difference|-0.103||||0.1677|2-Sided|95.0|-0.251|0.044|||Mixed Models Analysis|Those with a baseline and at least 1 postbaseline value at the PBO controlled phase were counted with mixed effects model for repeated measure (MMRM)|The LS mean (SE) and 2-sided p-value were based on a MMRM analysis for change from baseline, with treatment group, time, treatment-by-time interaction, and previous DMARD and baseline corticosteroids used as factors and baseline value as a covariate||
1640733|NCT01925768|3014370|Superiority or Other (legacy)||Adjusted Difference|17.7||||0.004|2-Sided|95.0|6.2|29.3||Two-sided p-value is based on the Cochran-Mantel-Haenszel test adjusting for previous DMARD use and baseline Oral Corticosteroids (Prednisone or equivalent) use.|Cochran-Mantel-Haenszel||Adjusted difference in proportions is the weighted average of the treatment differences across 4 strata by the 2 stratification factors: previous DMARD use and baseline Corticosteroids use using CMH weights. The CI is based on a normal approximation.||
1640734|NCT01925469|3014384|Superiority or Other|||||||0.33|||||||Wilcoxon (Mann-Whitney)||||
1640735|NCT01925469|3014385|Superiority or Other|||||||0.4|||||||Fisher Exact|||Fisher exact test was used to assess differences in satisfaction scores by treatment group. Correlation between pain and satisfaction scores was assessed by Spearman’s correlation coefficient.|
1640736|NCT01925469|3014386|Superiority or Other|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Differences in the median change in pain scores were assessed using Wilcoxon rank sum test.||An a priori sample size calculation determined at least 28 patients were needed to detect a clinically significant 13 mm difference in pain score (α=0.05, power =0.80) with a standard deviation of 12 mm. Intention to treat analysis was performed.|
1640737|NCT01925404|3014393|Superiority|We fitted difference-in-differences (DID) models between the two measurement waves and four study arms. The effect of the intervention was modeled as the wave by study arm interaction. All models used random effects to account for intra-class correlation within each park as well as fixed effects to account for observation times (time of day, weekend versus weekdays).||||||0.0063||||||Significance threshold. p=0.05|negative binomial distribution|||Comparison of change from baseline;|
1640738|NCT01925274|3014424|Superiority or Other||Mean Difference (Net)|-35.71||||0.164|2-Sided|95.0|-83.4|12.0|||Chi-squared||||
1640739|NCT01925209|3014432|Superiority or Other||Mean Difference (Net)|-1.31|Standard Error of the Mean|14.121||0.9263|2-Sided|99.0|-37.97|35.36|||mixed models repeated measures||||
1640740|NCT01925209|3014432|Superiority or Other||Mean Difference (Net)|18.59|Standard Error of the Mean|14.176||0.1909|2-Sided|99.0|-18.21|55.4|||mixed model repeated measure||||
1640741|NCT01925209|3014432|Superiority or Other||Mean Difference (Net)|17.59|Standard Error of the Mean|14.331||0.221|2-Sided|99.0|-19.63|54.8|||mixed model repeated measures||||
1640742|NCT01925170|3014435|Superiority or Other||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05|
1640743|NCT01925170|3014435|Superiority or Other||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05|
1640744|NCT01925170|3014436|Superiority or Other||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05|
1640745|NCT01925170|3014436|Superiority or Other||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05|
1640746|NCT01925170|3014437|Superiority or Other|||||||0.004|||||||McNemar|||Significant difference p ≤ 0.05|
1640747|NCT01925170|3014437|Superiority or Other||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05|
1640748|NCT01925170|3014438|Superiority or Other||||||<|0.0001|||||||McNemar|||Significant difference p ≤ 0.05|
1640749|NCT01925170|3014438|Superiority or Other||||||<|0.001|||||||McNemar|||Significant difference p ≤ 0.05|
1640750|NCT01925170|3014439|Superiority or Other|||||||0.004|||||||t-test, 2 sided|||Comparison of two groups for all densities; significant difference p ≤ 0.05.|
1640751|NCT01925170|3014439|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Comparison of the two groups for all densities, significant difference p ≤ 0.05.|
1640752|NCT01925014|3014456|Non-Inferiority|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|Risk Difference (RD)|0.035|||||2-Sided|95.0|-0.021|0.091|||||The non-inferiority was established.|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|
1640753|NCT01925014|3014457|Non-Inferiority|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|Risk Difference (RD)|0.013|||||2-Sided|95.0|-0.008|0.033|||||The non-inferiority was established.|Detailed in Ahn S, LOCAT Group. Trials 2014:15:28.|
1640754|NCT01924767|3014488|Superiority or Other||Mean Difference (Final Values)|-8.998||||0.1318|2-Sided|95.0|-20.818|2.822||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8|
1640755|NCT01924767|3014488|Superiority or Other||Mean Difference (Final Values)|-2.719||||0.6527|2-Sided|95.0|-14.842|9.403||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8|
1640756|NCT01924767|3014488|Superiority or Other||Mean Difference (Final Values)|-12.844||||0.0421||95.0|-25.205|-0.484||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8|
1640757|NCT01924767|3014488|Superiority or Other||Mean Difference (Final Values)|-7.269||||0.2239|2-Sided|95.0|-19.162|4.624||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent change in Fasting Plasma Glucose from baseline with treatment compared with placebo from baseline -2 to day 8|
1640758|NCT01924767|3014489|Superiority or Other||Difference to placebo|-10.602||||0.1676|2-Sided|95.0|-25.848|4.644||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8|
1640759|NCT01924767|3014489|Superiority or Other||Mean Difference (Final Values)|-14.956||||0.0521|2-Sided|95.0|-30.057|0.145||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8|
1640760|NCT01924767|3014489|Superiority or Other||Mean Difference (Final Values)|-23.467||||0.0042|2-Sided|95.0|-39.085|-7.848||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8|
1640761|NCT01924767|3014489|Superiority or Other||Mean Difference (Final Values)|-15.456||||0.0449|2-Sided|95.0|-30.543|-0.369||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo was calculated.|The mean percent decrease in Mean daily glucose from baseline with treatment compared with placebo from baseline -2 to day 8|
1640762|NCT01924767|3014490|Superiority or Other||Mean Difference (Final Values)|91306.96|||<|0.0001|2-Sided|95.0|64685.41|117928.5||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean Difference to placebo was calculated|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).|
1640763|NCT01924767|3014490|Superiority or Other||Mean Difference (Final Values)|79982.89|||<|0.0001|2-Sided|95.0|53087.22|106878.6||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean Difference to placebo is calculated.|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).|
1640764|NCT01924767|3014490|Superiority or Other||Mean Difference (Final Values)|82898.2|||<|0.0001|2-Sided|95.0|55344.83|110451.6||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.|Mean difference to placebo is calculated.|The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).|
1640765|NCT01924767|3014490|Superiority or Other||Mean Difference (Final Values)|37645.43|||<|0.0067|2-Sided|95.0|11021.57|64269.3||This was non-confirmatory testing.|ANCOVA|The baseline value has been used a continuous covariate.||The mean change from baseline (day -2) to day 8 and comparisons to placebo for Urine Glucose Excretion (AE(0-24)).|
1640766|NCT01924767|3014501|Superiority or Other||Geometric mean of ratio|37.632|||||2-Sided|95.0|15.429|91.789||||||This was non confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, at steady state, day 9) was analysed.|
1640767|NCT01924767|3014501|Superiority or Other||Geometric mean of ratio|49.707|||||2-Sided|95.0|33.49|73.776||||||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for AUC (0-infinity, single dose) was analysed.|
1640768|NCT01924767|3014502|Superiority or Other||Geometric Mean of ratio|31.234|||||2-Sided|95.0|12.193|80.011||||||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax,ss (Multiple dose) was analysed.|
1640769|NCT01924767|3014502|Superiority or Other||Geometric Mean of ratio|43.661|||||2-Sided|95.0|27.52|69.269||||||This was non-confirmatory testing, dose proportionality of dose from 2.5mg to 100mg for Cmax (single dose) was analysed.|
1640770|NCT01924533|3014521|Superiority or Other (legacy)||Hazard Ratio (HR)|0.63||||0.0927|2-Sided|97.5|0.34|1.16|||Cox proportional hazards model||||
1640771|NCT01924533|3014522|Superiority or Other (legacy)||Hazard Ratio (HR)|0.82||||0.0716|2-Sided|97.5|0.64|1.05|||Cox proportional hazards model||||
1640772|NCT01924533|3014523|Superiority or Other (legacy)||Odds Ratio (OR)|4.24||||0.0309|2-Sided|97.5|0.95|23.23|||Regression, Logistic||||
1640773|NCT01924533|3014524|Superiority or Other (legacy)||Odds Ratio (OR)|1.69||||0.0548|2-Sided|97.5|0.92|3.17|||Regression, Logistic||||
1640774|NCT01924533|3014525|Superiority or Other (legacy)||Hazard Ratio (HR)|0.74||||0.2199|2-Sided|97.5|0.42|1.29|||Cox proportional hazards model||||
1640775|NCT01924533|3014526|Superiority or Other (legacy)||Hazard Ratio (HR)|0.84||||0.0645|2-Sided|97.5|0.67|1.04|||Cox proportional hazards model||||
1640776|NCT01924533|3014527|Superiority or Other (legacy)||Hazard Ratio (HR)|0.73||||0.2458|2-Sided|97.5|0.4|1.34|||Cox proportional hazards model||||
1640777|NCT01924533|3014528|Superiority or Other (legacy)||Hazard Ratio (HR)|0.79||||0.0262|2-Sided|97.5|0.63|1.0|||Cox proportional hazards model||||
1640778|NCT01923428|3014725|Superiority||Risk Difference (RD)|27.0|||<|0.001|2-Sided|95.0|||||Cochran-Mantel-Haenszel||||
1640779|NCT01923311|3014763|Equivalence|A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG Cmax in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG Cmax is 0.28 ng•h/mL (natural log scale, estimated from EVG population PK modeling).|GLSM Ratio (%) (Test/Reference)|146.68|||||2-Sided|90.0|127.35|168.94||||||To determine whether the proposed EVG dose in children achieves similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).|
1640780|NCT01923311|3014764|Equivalence|A total of 12 test study participants compared to 334 HIV-infected reference study participants will provide at least 90% power to conclude exposure equivalence of EVG AUCtau in test study vs reference study, assuming the expected geometric mean ratio is 1, equivalency boundary is 70% to 143%, 2 one-sided tests are each performed at an alpha level of 0.05, and the standard deviation of EVG AUCtau is 0.36 ng•h/mL (natural log scale, estimated from EVG population PK modeling).|GLSM Ratio (%) (Test/Reference)|135.73|||||2-Sided|90.0|116.24|158.49||||||To determine whether the proposed EVG dose in children achieved similar systemic exposure to adults, statistical comparisons were performed with PK data from the current study (test) and adult data from population PK modeling in study GS-US-183-0145 (NCT00708162) (reference).|
1640781|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|0.09||||0.5565|2-Sided|95.0|-0.21|0.39|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Oral semaglutide 40 mg slow-dose escalation|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640814|NCT01922050|3014864|Superiority||Ratio of clearance rates|1.69|||<|0.026|2-Sided|95.0|1.06|2.69|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.|
1640782|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|0.26||||0.0989|2-Sided|95.0|-0.05|0.56|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Oral semaglutide 40 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640783|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|0.17||||0.2669|2-Sided|95.0|-0.13|0.46|||Mixed Models Analysis||Oral semaglutide 40 mg slow-dose escalation - Oral semaglutide 40 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640784|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|0.22||||0.1612|2-Sided|95.0|-0.09|0.52|||Mixed Models Analysis||Oral semaglutide 40 mg fast-dose escalation - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640785|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|0.13||||0.3901|2-Sided|95.0|-0.16|0.42|||Mixed Models Analysis||Oral semaglutide 40 mg slow-dose escalation - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640786|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.04||||0.7973|2-Sided|95.0|-0.34|0.26|||Mixed Models Analysis||Oral semaglutide 40 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640787|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|0.18||||0.244|2-Sided|95.0|-0.12|0.47|||Mixed Models Analysis||Oral semaglutide 20 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640788|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|0.37||||0.0116|2-Sided|95.0|0.08|0.67|||Mixed Models Analysis||Oral semaglutide 10 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640789|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|0.67|||<|0.0001|2-Sided|95.0|0.38|0.96|||Mixed Models Analysis||Oral semaglutide 5 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640790|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|1.16|||<|0.0001|2-Sided|95.0|0.87|1.45|||Mixed Models Analysis||Oral semaglutide 2.5 mg - Subcutaneous semaglutide 1 mg|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640791|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.56|||<|0.0001|2-Sided|95.0|-1.85|-1.27|||Mixed Models Analysis||Subcutaneous semaglutide 1 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640792|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.34|||<|0.0001|2-Sided|95.0|-1.64|-1.04|||Mixed Models Analysis||Oral semaglutide 40 mg fast dose-escalation - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640793|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.43|||<|0.0001|2-Sided|95.0|-1.72|-1.14|||Mixed Models Analysis||Oral semaglutide 40 mg slow dose-escalation - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640815|NCT01922050|3014865|Superiority||Ratio of clearance rates|1.43||||0.29|2-Sided|95.0|0.74|2.75|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.|
1640816|NCT01922050|3014865|Superiority||Ratio of clearance rates|2.55||||0.031|2-Sided|95.0|1.09|5.98|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.|
1640794|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.6|||<|0.0001|2-Sided|95.0|-1.89|-1.3|||Mixed Models Analysis||Oral semaglutide 40 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640795|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.38|||<|0.0001|2-Sided|95.0|-1.68|-1.09|||Mixed Models Analysis||Oral Semaglutide 20 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640796|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|-1.18|||<|0.0001|2-Sided|95.0|-1.47|-0.9|||Mixed Models Analysis||Oral semaglutide 10 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640797|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.89|||<|0.0001|2-Sided|95.0|-1.18|-0.6|||Mixed Models Analysis||Oral semaglutide 5 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640798|NCT01923181|3014771|Superiority|This hypothesis was not controlled for multiplicity.|Treatment difference|-0.4|||<|0.0069|2-Sided|95.0|-0.69|-0.11|||Mixed Models Analysis||Oral semaglutide 2.5 mg - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640799|NCT01923181|3014771|Superiority|This hypothesis was controlled for multiplicity.|Mean treatment difference|-1.47|||<|0.0001|2-Sided|95.0|-1.73|-1.22|||Mixed Models Analysis||Oral semaglutide 40 mg pooled - Placebo|Results are based on the data from the on-treatment without rescue medication observation period. The analysis was based on mixed model for repeated measurements with treatment, stratum and country as fixed factors and baseline value as covariate, all nested within visit. Group mean estimates were adjusted according to observed baseline distribution.|
1640800|NCT01923168|3014800|Other|Bayesian double criteria|Mean Difference (Final Values)|2.4||||0.611|2-Sided|80.0|-8.4|13.2|||Posterior mean diff. & credible interval||||
1640801|NCT01923168|3014801|Other|Bayesian double criteria|Mean Difference (Final Values)|-1.4||||0.435|2-Sided|80.0|-12.5|9.7|||Posterior mean diff. & credible interval||||
1640802|NCT01923168|3014802|Other|Bayesian double criteria|Mean Difference (Final Values)|1.1||||0.697|2-Sided|80.0|-1.9|4.2|||Posterior mean difference|Posterior mean difference|||
1640803|NCT01923168|3014803|Other|Bayesian double criteria|Mean Difference (Final Values)|-1.3||||0.282|2-Sided|80.0|-4.5|1.7|||Posterior mean diff. & credible interval||||
1640804|NCT01923129|3014804|Non-Inferiority|The primary outcome of interest was the rate of AUR, defined as the number of patients with AUR within each study group. A 15% non-inferiority margin was chosen according to clinical relevance estimation. The expected difference between the two groups was 0%. Non-inferiority analysis was performed by calculation of risk difference and its 95% confidence interval according to Newcombe & Altman.|||||<|0.05|||||||Chi-squared||||
1640805|NCT01922934|3014812|Other||||||<|0.001|||||||Chi-squared||||
1640806|NCT01922102|3014859|Non-Inferiority or Equivalence|"one-sided hypotheses were tested under the Type I error rate of 0.025, if H01 and H02 were rejected: H03: μRanibizumab-II - μRanibizumab-I ≤ -5 vs. HA3: μRanibizumab-II - μRanibizumab-I > -5.~Otherwise, H03 was not to be considered as rejected."|Mean Difference (Net)|0.4|||<|0.001|2-Sided|95.0|-1.3|2.1||Non-inferiority could be claimed if the corresponding one-sided p-value was ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.||
1640807|NCT01922102|3014860|Superiority or Other||Mean Difference (Net)|5.6|||<|0.001|2-Sided|95.0|3.5|7.6||Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|"The following 2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure:~H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT > 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT > 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively."|
1640808|NCT01922102|3014860|Superiority or Other||Mean Difference (Net)|5.2|||<|0.001|2-Sided|95.0|3.3|7.1||Superiority could be claimed if the corresponding one-sided p-value was ≤ 0.025/2 = 0.0125, or if both one-sided p-values were ≤ 0.025.|Cochran-Mantel-Haenszel||Differences in LS means and the two-sided 95% CIs are estimated from pairwise ANOVA (stratified) model.|2 one-sided hypotheses were tested under the Type I error rate of 0.025, using the Hochberg procedure: H01: μRanibizumab-I - μvPDT ≤ 0 vs. HA1: μRanibizumab-I - μvPDT > 0 and H02: μRanibizumab-II - μvPDT ≤ 0 vs. HA2: μRanibizumab-II - μvPDT > 0, where μRanibizumab-I, μRanibizumab-II and μvPDT were the means of the primary efficacy variable for ranibizumab treatment Group I, ranibizumab treatment Group II, and vPDT treatment Group III, respectively.|
1640809|NCT01922050|3014864|Superiority||Ratio of clearance rates|1.17||||0.3|2-Sided|95.0|0.87|1.57|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.|
1640810|NCT01922050|3014864|Superiority||Ratio of clearance rates|1.24||||0.16|2-Sided|95.0|0.92|1.67|||Log binomial regression||||
1640817|NCT01922050|3014865|Superiority||Ratio of clearance rates|1.79||||0.21|2-Sided|95.0|0.72|4.43|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.|
1640818|NCT01922050|3014865|Superiority||Ratio of clearance rates|1.9||||0.11|2-Sided|95.0|0.86|4.21|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.|
1640819|NCT01922050|3014865|Superiority||Ratio of clearance rates|1.33||||0.51|2-Sided|95.0|0.56|3.13|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.|
1640820|NCT01922050|3014865|Superiority||Ratio of clearance rates|0.74||||0.57|2-Sided|95.0|0.27|2.04|||Log binomial regression|||Log binomial regression with treatment group as factor and baseline AK count included as covariate.|
1640821|NCT01922050|3014866|Superiority||Rate ratio|0.79||||0.13|2-Sided|95.0|0.58|1.07|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.|||
1640822|NCT01922050|3014866|Superiority||Rate ratio|0.69||||0.013|2-Sided|95.0|0.52|0.93|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.|||
1640823|NCT01922050|3014866|Superiority||Rate ratio|0.88||||0.38|2-Sided|95.0|0.66|1.17|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.|||
1640824|NCT01922050|3014866|Superiority||Rate ratio|0.36|||<|0.001|2-Sided|95.0|0.28|0.48|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.|||
1640825|NCT01922050|3014866|Superiority||Rate ratio|0.46|||<|0.001|2-Sided|95.0|0.35|0.61|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.|||
1640826|NCT01922050|3014866|Superiority||Rate ratio|0.53|||<|0.001|2-Sided|95.0|0.4|0.69|||Negative binominal regression|Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.|||
1640827|NCT01922011|3014906|Superiority or Other||Common difference|-10.4|||||2-Sided|95.0|-25.4|5.2|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|MSSA|
1640828|NCT01922011|3014906|Superiority or Other||Common difference|-12.2|||||2-Sided|95.0|-27.2|2.8|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|SA|
1640829|NCT01922011|3014906|Superiority or Other||Common difference|-10.1|||||2-Sided|95.0|-24.8|4.2|||||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|Overall Baseline Infecting Pathogen|
1640830|NCT01922011|3014907|Superiority or Other||Common difference|-4.8||||0.48|2-Sided|95.0|-17.6|7.9|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|TOC|
1640831|NCT01922011|3014907|Superiority or Other||Common difference|-6.3||||0.272|2-Sided|95.0|-18.2|5.5|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|EOT|
1640832|NCT01922011|3014908|Superiority or Other|||||||0.28|||||||Wald|||Other Pathogen|
1640833|NCT01922011|3014908|Superiority or Other|||||||0.45|||||||Wald|||MRSA|
1640834|NCT01922011|3014908|Superiority or Other||Common difference|-15.5||||0.043|2-Sided|95.0|-31.2|1.1|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|MSSA|
1640835|NCT01922011|3014908|Superiority or Other||Common difference|-12.3||||0.164|2-Sided|95.0|-28.5|4.4|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|SA|
1640836|NCT01922011|3014908|Superiority or Other||Common difference|-10.5||||0.23|2-Sided|95.0|-26.3|5.4|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|Overall Baseline Infecting Pathogen|
1640837|NCT01922011|3014909|Superiority or Other||Common difference|-6.7||||0.37|2-Sided|95.0|-19.1|5.8|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At TOC visit|
1640838|NCT01922011|3014909|Superiority or Other||Common difference|-7.9||||0.239|2-Sided|95.0|-19.8|4.0|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At EOT visit|
1640839|NCT01922011|3014909|Superiority or Other||Common difference|-6.2||||0.313|2-Sided|95.0|-17.5|5.0|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|At EOIV visit|
1640840|NCT01922011|3014910|Superiority or Other||Common difference|-7.1||||0.467|2-Sided|95.0|-21.6|7.9|||Wald||95% confidence interval of the common difference ( Daptomycin minus Vancomycin or Nafcillin) is based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.||
1640881|NCT01920594|3015080|Superiority||Mean Difference (Final Values)|2228.14||||0.082|2-Sided|95.0|-292.84|4749.11|||ANCOVA||The point estimate was calculated as least square (LS) mean difference (final values) of S-100B Protein [test] and S-100B Protein [reference].||
1641993|NCT01884545|3018052|Superiority|||||||0.9062|||||||Regression, Linear||||
1640841|NCT01922011|3014911|Non-Inferiority or Equivalence|Non-inferiority was concluded if the lower bound of the 2-sided 95% CI is greater than -15%|Common Difference|-6.1||||0.421|2-Sided|95.0|-19.4|7.4|||Wald||Daptomycin – Comparator|95% confidence interval of the common difference was based on stratified Newcombe confidence interval (CI) with minimum risk weights, with age cohort as the stratification factor.|
1640842|NCT01921829|3014917|Superiority||||||>|0.95|||||||Fisher Exact||||
1640843|NCT01921829|3014918|Superiority||||||>|0.95|||||||t-test, 2 sided||||
1640844|NCT01921829|3014919|Superiority|||||||0.55|||||||t-test, 2 sided||||
1640845|NCT01921829|3014920|Superiority||||||>|0.95|||||||t-test, 2 sided||||
1640846|NCT01921829|3014921|Superiority|||||||0.4|||||||t-test, 2 sided||||
1640847|NCT01921829|3014922|Superiority|||||||0.17|||||||t-test, 2 sided||||
1640848|NCT01921829|3014923|Superiority|||||||0.17|||||||t-test, 2 sided||||
1640849|NCT01921829|3014924|Superiority|||||||0.52|||||||t-test, 2 sided||||
1640850|NCT01921829|3014925|Superiority||||||>|0.95|||||||t-test, 2 sided||||
1640851|NCT01921829|3014926|Superiority||||||>|0.95|||||||t-test, 2 sided||||
1640852|NCT01921829|3014927|Superiority|||||||0.52|||||||t-test, 2 sided||||
1640853|NCT01921829|3014928|Superiority||||||>|0.95|||||||t-test, 2 sided||||
1640854|NCT01921829|3014929|Superiority|||||||0.08|||||||t-test, 2 sided||||
1640855|NCT01921829|3014930|Superiority||||||>|0.95|||||||Fisher Exact||||
1640856|NCT01921829|3014931|Superiority|||||||0.4|||||||t-test, 2 sided||||
1640857|NCT01921829|3014932|Superiority|||||||0.86|||||||t-test, 2 sided||||
1640858|NCT01921829|3014933|Superiority|||||||0.58|||||||Fisher Exact||||
1640859|NCT01921829|3014934|Superiority||||||>|0.95|||||||Fisher Exact||||
1640860|NCT01921829|3014936|Superiority|||||||0.29|||||||t-test, 2 sided||||
1640861|NCT01921829|3014937|Superiority|||||||0.05|||||||t-test, 2 sided||||
1640862|NCT01921517|3014942|Superiority|||||||0.0481|||||||t-test, 2 sided||||
1640863|NCT01921205|3014984|Superiority||Percent reduction over Placebo|31.72|||=|0|2-Sided|95.0|16.342|44.277|||ANCOVA|Seizure frequency (log transformed) is analyzed using analysis of covariance with terms for treatment, pooled center and Baseline seizure frequency.|Percent reduction over placebo is estimated as 100 x (1-exp[LSMLacosamide-LSMPlacebo]). Where LSM is Least Square Mean.||
1640864|NCT01921179|3014985|Equivalence|A repeated measure multivariate analysis of variance (MANOVA) was used to compare participants' self-report on POMS Total Mood Disturbance overall score at baseline and 6+ month post-GOALS training follow-up|||||<|0.01|||||||ANOVA||||
1640865|NCT01921179|3014986|Equivalence|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on emotional regulation measures - POMS Total score|||||<|0.05|||||||ANOVA|A repeated measures MANOVA was used to compare the impact of GOALS versus the BHE training on emotional regulation measures - POMS Total score|||
1640866|NCT01921179|3014987|Equivalence|A repeated measure multivariate analysis of variance (MANOVA) was used to compare performance on Goal Processing Scale Overall domain scores at baseline and 6+ month post-GOALS training follow-up|||||<|0.001|||||||ANOVA||||
1640867|NCT01921179|3014988|Equivalence|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance|||||>|0.05|||||||ANOVA|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on functional performance|||
1640868|NCT01921179|3014989|Equivalence|A repeated measure multivariate analysis of variance (MANOVA) was used to compare neurocognitive performance on Overall Attention /Executive Function overall score at baseline and at 6+ month post-GOALS training follow-up|||||<|0.001|||||||ANOVA|Repeated measure MANOVA was used to compare performance on neurocognitive domain scores at baseline and at 6+ month follow-up post-GOALS training|||
1640869|NCT01921179|3014990|Equivalence|A repeated measures MANOVA was used to compare the impact of GOALS training versus the BHE training on neurocognitive performance Attention and Executive Function Overall Domain Z Score|||||<|0.01|||||||ANOVA||||
1640870|NCT01921101|3015001|Superiority or Other|||||||0.29|||||||Chi-squared||||
1640871|NCT01920893|3015025|Superiority||Least Square (LS) mean difference|-1.55||||0.0009|2-Sided|95.0|-2.43|-0.67||Threshold for significance at 0.05 level.|Mixed Models Analysis||Dupilumab 300 mg QW vs Placebo|Analysis was performed by a mixed model repeated measures (MMRM) model.|
1640872|NCT01920594|3015063|Superiority||Ratio of geometric mean|0.75||||0.8053|2-Sided|95.0|0.07|8.57|||ANOVA|||For Troponin T|
1640873|NCT01920594|3015063|Superiority||Ratio of geometric mean|1.84||||0.5012|2-Sided|95.0|0.3|11.32|||ANOVA|||For Troponin I|
1640874|NCT01920594|3015068|Superiority||Mean Difference (Final Values)|4.11||||0.0893|2-Sided|95.0|-0.65|8.87|||ANCOVA||The point estimate was calculated as LS mean difference final values of Neuron Specific Enolase[test] and Neuron Specific Enolase[reference].||
1640875|NCT01920594|3015069|Superiority||Mean Difference (Final Values)|925.88||||0.0526|2-Sided|95.0|-10.73|1862.49|||ANCOVA||The point estimate was calculated as LS mean difference final values of Tau Protein[test] and Tau Protein[reference].||
1640876|NCT01920594|3015070|Superiority||Mean Difference (Final Values)|0.54||||0.2404|2-Sided|95.0|-0.37|1.45|||ANCOVA||The point estimate was calculated as LS mean difference final values of Lactate Dehydrogenase[test] and Lactate Dehydrogenase[reference].||
1640877|NCT01920594|3015071|Superiority||Mean Difference (Final Values)|34.56|||<|0.0001|2-Sided|95.0|21.95|47.17|||ANCOVA||The point estimate was calculated as LS mean difference final values of Erythropoietin[test] and Erythropoietin[reference].||
1640878|NCT01920594|3015072|Superiority||Estimate of comparison (Ratio)|3.13||||0.1377|2-Sided|95.0|0.69|14.26|||ANOVA||The point estimate was calculated as Geometric mean ratio of GFAP[test] and GFAP[reference].||
1640879|NCT01920594|3015073|Superiority||Estimate of comparison (Ratio)|1.77||||0.153|2-Sided|95.0|0.8|3.9|||ANOVA||The point estimate was calculated as Geometric mean ratio of S-100B[test] and S-100B[reference].||
1640880|NCT01920594|3015079|Superiority||Mean Difference (Final Values)|777.95||||0.1997|2-Sided|95.0|-424.04|1979.94|||ANCOVA||The point estimate was calculated as LS mean difference (final values) of GFAP [test] and GFAP [reference].||
1641994|NCT01884545|3018052|Superiority|||||||0.2192|||||||Regression, Linear||||
1640882|NCT01920568|3015087|Superiority or Other||Mean Difference (Final Values)|-0.366|||<|0.0001|2-Sided|95.0|-0.539|-0.193|||ANCOVA||Secondary analysis evaluated the log transformed chg from BL, i.e. log[(Wk 13 uNTx/Cr) / (BL uNTx/Cr)] by ANCOVA model with trt group as main effect, stratification factor (Breast cancer, yes or no) and log transformed BL value as covariates.||
1640883|NCT01920568|3015088|Superiority or Other||Mean Difference (Final Values)|-0.316|||<|0.0001|2-Sided|95.0|-0.444|-0.188|||ANCOVA||Secondary analysis evaluated the log transformed chg from BL, ie log[(Wk 13 uNTx/Cr)/(BL uNTx/Cr)] by ANCOVA model with trt group as main effect and the stratification factor (Chinese participants, yes or no) and log transformed BL value||
1640884|NCT01920568|3015089|Superiority or Other||Mean Difference (Final Values)|-0.316|||<|0.0001|2-Sided|95.0|-0.44|-0.192|||ANCOVA||Primary analysis evaluated the log transformed chg from BL, i.e. log[(Wk 13 uNTx/Cr) / (BL uNTx/Cr)] by ANCOVA model with trt group as main effect and the stratification factor (breast cancer, yes or no) and log transformed BL value as covariates.||
1640885|NCT01920555|3015093|Superiority||Mean Difference (Final Values)|-0.43||||1|2-Sided|95.0|-3.22|2.35||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640886|NCT01920555|3015093|Superiority||Mean Difference (Final Values)|-1.17||||1|2-Sided|95.0|-3.91|1.58||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640887|NCT01920555|3015093|Superiority||Mean Difference (Final Values)|2.76||||0.39|2-Sided|95.0|-0.06|5.59||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640888|NCT01920555|3015093|Superiority||Mean Difference (Final Values)|-0.29||||1|2-Sided|95.0|-3.25|2.66||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640889|NCT01920555|3015093|Superiority||Mean Difference (Final Values)|-0.71||||1|2-Sided|95.0|-3.35|1.93||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640890|NCT01920555|3015093|Superiority||Mean Difference (Final Values)|-2.74||||0.3|2-Sided|95.0|-5.32|-0.16||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640891|NCT01920555|3015093|Superiority||Mean Difference (Final Values)|0.76||||0.17|2-Sided|95.0|-1.9|3.43||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640892|NCT01920555|3015093|Superiority||Mean Difference (Final Values)|-1.21||||1|2-Sided|95.0|-3.99|1.56||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640893|NCT01920555|3015094|Superiority||Mean Difference (Final Values)|4.8||||1|2-Sided|95.0|-8.31|17.91||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640894|NCT01920555|3015094|Superiority||Mean Difference (Final Values)|7.64||||1|2-Sided|95.0|-5.26|20.53||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640895|NCT01920555|3015094|Superiority||Mean Difference (Final Values)|-6.64||||1|2-Sided|95.0|-19.87|6.59||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640896|NCT01920555|3015094|Superiority||Mean Difference (Final Values)|5.11||||1|2-Sided|95.0|-8.83|19.05||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640897|NCT01920555|3015094|Superiority||Mean Difference (Final Values)|8.68||||0.82|2-Sided|95.0|-2.81|20.16||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640898|NCT01920555|3015094|Superiority||Mean Difference (Final Values)|16.54||||0.03|2-Sided|95.0|5.31|27.77||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640899|NCT01920555|3015094|Superiority||Mean Difference (Final Values)|1.37||||1|2-Sided|95.0|-10.19|12.93||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640900|NCT01920555|3015094|Superiority||Mean Difference (Final Values)|11.18||||0.49|2-Sided|95.0|-0.94|23.29||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640901|NCT01920555|3015095|Superiority||Mean Difference (Final Values)|-0.29||||0.88|2-Sided|95.0|-0.76|0.19||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640902|NCT01920555|3015095|Superiority||Mean Difference (Final Values)|-0.32||||0.88|2-Sided|95.0|-0.79|0.15||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640903|NCT01920555|3015095|Superiority||Mean Difference (Final Values)|-0.05||||1|2-Sided|95.0|-0.53|0.44||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640957|NCT01918033|3015263|Superiority or Other||Difference in LS Means|-0.06||||0.414|2-Sided|95.0|-0.2|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2||
1640904|NCT01920555|3015095|Superiority||Mean Difference (Final Values)|-0.33||||0.88|2-Sided|95.0|-0.83|0.18||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640905|NCT01920555|3015095|Superiority||Mean Difference (Final Values)|-0.31||||0.8|2-Sided|95.0|-0.72|0.1||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640906|NCT01920555|3015095|Superiority||Mean Difference (Final Values)|-0.61||||0.02|2-Sided|95.0|-1.01|-0.21||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640907|NCT01920555|3015095|Superiority||Mean Difference (Final Values)|0.04||||1|2-Sided|95.0|-0.37|0.45||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640908|NCT01920555|3015095|Superiority||Mean Difference (Final Values)|-0.35||||0.74|2-Sided|95.0|-0.79|0.08||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640909|NCT01920555|3015096|Superiority||Mean Difference (Final Values)|-0.62||||0.54|2-Sided|95.0|-1.33|0.1||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640910|NCT01920555|3015096|Superiority||Mean Difference (Final Values)|-0.64||||0.52|2-Sided|95.0|-1.35|0.06||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640911|NCT01920555|3015096|Superiority||Mean Difference (Final Values)|-0.21||||1|2-Sided|95.0|-0.93|0.51||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640912|NCT01920555|3015096|Superiority||Mean Difference (Final Values)|-0.19||||1|2-Sided|95.0|-0.96|0.57||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640913|NCT01920555|3015096|Superiority||Mean Difference (Final Values)|-0.56||||0.54|2-Sided|95.0|-1.24|0.11||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640958|NCT01918033|3015264|Superiority or Other||Difference in LS Means|-0.03||||0.699|2-Sided|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Itching at Week 2||
1640914|NCT01920555|3015096|Superiority||Mean Difference (Final Values)|-0.98||||0.03|2-Sided|95.0|-1.64|-0.31||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640915|NCT01920555|3015096|Superiority||Mean Difference (Final Values)|-0.1||||1|2-Sided|95.0|-0.78|0.58||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640916|NCT01920555|3015096|Superiority||Mean Difference (Net)|-0.54||||0.54|2-Sided|95.0|-1.25|0.17||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640917|NCT01920555|3015097|Superiority||Mean Difference (Final Values)|-0.86||||0.27|2-Sided|95.0|-1.78|0.07||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640918|NCT01920555|3015097|Superiority||Mean Difference (Final Values)|-1.0||||0.16|2-Sided|95.0|-1.91|-0.09||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640919|NCT01920555|3015097|Superiority||Mean Difference (Final Values)|-0.39||||0.82|2-Sided|95.0|-1.32|0.55||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640920|NCT01920555|3015097|Superiority||Mean Difference (Final Values)|-0.71||||0.48|2-Sided|95.0|-1.7|0.28||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640921|NCT01920555|3015097|Superiority||Mean Difference (Final Values)|-1.05||||0.04884|2-Sided|95.0|-1.81|-0.29||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640922|NCT01920555|3015097|Superiority||Mean Difference (Final Values)|-1.28||||0.0072|2-Sided|95.0|-2.02|-0.54||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640923|NCT01920555|3015097|Superiority||Mean Difference (Final Values)|-0.26||||0.82|2-Sided|95.0|-1.02|0.51||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640959|NCT01918033|3015264|Superiority or Other||Difference in LS Means|-0.08||||0.345|2-Sided|95.0|-0.23|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Itching at Week 2||
1641995|NCT01884545|3018053|Superiority|||||||0.2297|||||||Regression, Linear||||
1640924|NCT01920555|3015097|Superiority||Mean Difference (Final Values)|-1.03||||0.08|2-Sided|95.0|-1.83|-0.22|||Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640925|NCT01920555|3015098|Superiority||Mean Difference (Final Values)|-7.72||||0.08|2-Sided|95.0|-14.52|-0.93||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640926|NCT01920555|3015098|Superiority||Mean Difference (Final Values)|-9.85||||0.02|2-Sided|95.0|-16.56|-3.15||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640927|NCT01920555|3015098|Superiority||Mean Difference (Final Values)|-2.16||||0.53|2-Sided|95.0|-9.03|4.72||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640928|NCT01920555|3015098|Superiority||Mean Difference (Final Values)|-5.15||||0.33|2-Sided|95.0|-12.44|2.14||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1 mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were four pairwise comparisons of interest (see Analysis 1-4), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640929|NCT01920555|3015099|Superiority||Mean Difference (Final Values)|-1.84||||0.72|2-Sided|95.0|-4.65|0.96||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 1.0mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640930|NCT01920555|3015099|Superiority||Mean Difference (Final Values)|-3.12||||0.14|2-Sided|95.0|-5.97|-0.44||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640931|NCT01920555|3015099|Superiority||Mean Difference (Final Values)|-0.36||||0.8|2-Sided|95.0|-3.18|2.46||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640932|NCT01920555|3015099|Superiority||Mean Difference (Final Values)|-2.04||||0.72|2-Sided|95.0|-5.04|0.95||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1mg/kg vs. midazolam at Day 3:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640933|NCT01920555|3015099|Superiority||Mean Difference (Final Values)|-3.76||||0.04|2-Sided|95.0|-6.37|-1.15|||Mixed Models Analysis|||"Ketamine 1.0mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640934|NCT01920555|3015099|Superiority||Mean Difference (Final Values)|-4.79|||<|0.01|2-Sided|95.0|-7.35|-2.24||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.5mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1641084|NCT01915914|3015384|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1640935|NCT01920555|3015099|Superiority||Mean Difference (Final Values)|-1.13|||<|0.79|2-Sided|95.0|-3.75|1.49||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.2mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640936|NCT01920555|3015099|Superiority||Mean Difference (Final Values)|-3.18|||<|0.14|2-Sided|95.0|-5.93|-0.43||Holm’s method was applied to the model-produced differences of least squares for the eight a priori identified contrasts of interest, that is, the difference between each ketamine group vs. placebo at Days 1 and 3.|Mixed Models Analysis|||"Ketamine 0.1mg/kg vs. midazolam at Day 1:~As estimated by the repeated measures fixed effects model with DAY (0, 1, 3), GROUP (5 groups as specified above), and the DAY*GROUP interaction effect. Because there were eight pairwise comparisons of interest (see Analysis 1-8), we used Holm’s method to protect family-wise error rate in the presence of multiple testing."|
1640937|NCT01919814|3015127|Superiority||||||>|0.05||||||Threshold P-Value was 0.05|t-test, 2 sided||||
1640938|NCT01919801|3015137|Superiority or Other|||||||0.633||||||Test was performed using a weighted log-rank test called the Peto-Prentice test with a global 2-sided significance level of 5% after adjusting for stratification factors (race, and severity) in the ITT population.|Adjusted Peto-Prentice|||A total of 121 participants were analysed, however 3 participants did not receive the study medication and were censored at time 0.|
1640939|NCT01918800|3015184|Superiority or Other|||||||0.36|||||||Wilcoxon (Mann-Whitney)||||
1640940|NCT01918800|3015185|Superiority or Other|||||||0.42|||||||Wilcoxon (Mann-Whitney)||||
1640941|NCT01918800|3015186|Superiority|||||||0.854|||||||Wilcoxon (Mann-Whitney)||||
1640942|NCT01918800|3015186|Superiority|||||||0.4199|||||||Wilcoxon (Mann-Whitney)|||This p values is for the RAPA Strength|
1640943|NCT01918800|3015186|Superiority or Other|||||||0.521||||||This p value applies to the RAPA Cardiovascular|Wilcoxon (Mann-Whitney)||||
1640944|NCT01918800|3015187|Superiority|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||The p value in this case refers to the SF-36 Mental|
1640945|NCT01918800|3015187|Superiority|||||||0.8||||||The p value in this case is for the SF-36 Physical|Wilcoxon (Mann-Whitney)||||
1640946|NCT01918800|3015188|Superiority or Other|||||||0.35||||||No adjustment for multiple comparisons|Paired t test||||
1640947|NCT01918800|3015189|Superiority or Other|||||||0.04||||||No adjustments for multiple comparisons.|paired t test||||
1640948|NCT01918800|3015190|Superiority or Other|||||||0.64||||||No adjustment for multiple comparisons. A priori threshold for clinical significance was 7 point improvement.|paired t test||||
1640949|NCT01918774|3015202|Other|Pre-post analysis comparing weeks worked in the 6 months preceding baseline and the 6 month study follow-up.|||||<|0.001||||||A priori threshold of significance was p<.05|within groups t-test||||
1640950|NCT01918189|3015250|Other|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of depression symptoms at 10 weeks post-baseline.|Mean Difference (Final Values)|0.05||||0.03|2-Sided|95.0||||a priori threshold for statistical significance is p<0.05|Regression, Logistic||||
1640951|NCT01918189|3015251|Other|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of sleep at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.18|2-Sided|95.0||||a priori threshold for statistical significance is p<0.05|Regression, Logistic||||
1640952|NCT01918189|3015252|Other|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of mood symptoms at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.48|2-Sided|||||a priori threshold for statistical significance is p<0.05|Regression, Logistic||||
1640953|NCT01918189|3015253|Other|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the measure of mood symptoms at 10 weeks post-baseline.|Mean Difference (Net)|0.05||||0.02|2-Sided|95.0||||a priori threshold for statistical significance is p<0.05|Regression, Logistic||||
1640954|NCT01918189|3015254|Other|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the primary measure of pain intensity at 10 weeks post-baseline.|Mean Difference (Final Values)|0.05||||0.27|2-Sided|95.0||||a priori threshold for statistical significance is p<0.05|Regression, Logistic||||
1640955|NCT01918189|3015255|Other|Mixed models (using an unstructured correlation structure) regression over the baseline and 10-week post-baseline follow-up assessments were used to examine change in outcome measures for preliminary efficacy variables. The primary endpoint for the preliminary efficacy analyses is the mean difference in baseline to post-baseline follow-up scores on the primary measure of pain interference (i.e., WHYMPI-Interference Scale) at 10 weeks post-baseline.||||||0.008||||||a priori threshold for statistical significance is p <0.05|Regression, Logistic||||
1640956|NCT01918033|3015263|Superiority or Other||Difference in LS Means|-0.08||||0.281|2-Sided|95.0|-0.22|0.06|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Eye Symptom Score at Week 2||
1640960|NCT01918033|3015264|Superiority or Other||Difference in LS Means|0.05||||0.49|2-Sided|95.0|-0.1|0.21|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2||
1640961|NCT01918033|3015264|Superiority or Other||Difference in LS Means|0.08||||0.285|2-Sided|95.0|-0.07|0.24|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Nasal Congestion at Week 2||
1640962|NCT01918033|3015264|Superiority or Other||Difference in LS Means|0.07||||0.375|2-Sided|95.0|-0.08|0.22|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2||
1640963|NCT01918033|3015264|Superiority or Other||Difference in LS Means|0.12||||0.13|2-Sided|95.0|-0.04|0.27|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Rhinorrhea at Week 2||
1640964|NCT01918033|3015264|Superiority or Other||Difference in LS Means|-0.12||||0.098|2-Sided|95.0|-0.26|0.02|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Sneezing at Week 2||
1640965|NCT01918033|3015264|Superiority or Other||Difference in LS Means|-0.1||||0.175|2-Sided|95.0|-0.24|0.04|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Sneezing at Week 2||
1640966|NCT01918033|3015265|Superiority or Other||Difference in LS Means|-0.02||||0.782|2-Sided|95.0|-0.13|0.1|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2||
1640967|NCT01918033|3015265|Superiority or Other||Difference in LS Means|0.02||||0.705|2-Sided|95.0|-0.09|0.14|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in Interference with Daily Activities at Week 2||
1640968|NCT01918033|3015266|Superiority or Other||Odds Ratio (OR)|0.755||||0.159|2-Sided|95.0|0.51|1.116|||Regression, Logistic|Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors|Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio >1 is in favor of the first group of the pairwise comparison.||
1640969|NCT01918033|3015266|Superiority or Other||Odds Ratio (OR)|0.826||||0.34|2-Sided|95.0|0.558|1.223|||Regression, Logistic|Logistic model with global improvement rate as response variable and treatment, age strata, and severity as factors|Difference in the number of participants with moderate or remarkable improvement at Week 2. An odds ratio >1 is in favor of the first group of the pairwise comparison.||
1640970|NCT01918033|3015267|Superiority or Other||Difference in LS Means|-0.07||||0.26|2-Sided|95.0|-0.2|0.06|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2||
1640971|NCT01918033|3015267|Superiority or Other||Difference in LS Means|-0.01||||0.849|2-Sided|95.0|-0.14|0.12|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Eye Symptom Score at Week 2||
1640972|NCT01918033|3015268|Superiority or Other||Difference in LS Means|0.06||||0.373|2-Sided|95.0|-0.07|0.19|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in NDP at Week 2||
1640973|NCT01918033|3015268|Superiority or Other||Difference in LS Means|0.03||||0.68|2-Sided|95.0|-0.1|0.16|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in NDP at Week 2||
1640974|NCT01918033|3015268|Superiority or Other||Difference in LS Means|-0.03||||0.708|2-Sided|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2||
1640975|NCT01918033|3015268|Superiority or Other||Difference in LS Means|-0.03||||0.725|2-Sided|95.0|-0.19|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Coloring of INCM at Week 2||
1640976|NCT01918033|3015268|Superiority or Other||Difference in LS Means|-0.03||||0.714|2-Sided|95.0|-0.16|0.11|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2||
1640977|NCT01918033|3015268|Superiority or Other||Difference in LS Means|-0.06||||0.376|2-Sided|95.0|-0.2|0.07|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Swelling of INCM at Week 2||
1640978|NCT01918033|3015269|Superiority or Other||Difference in LS Means|-0.06||||0.403|2-Sided|95.0|-0.2|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2||
1641085|NCT01915914|3015385|Superiority or Other||Hazard Ratio (HR)|4.9524|||<|0.0001|2-Sided|95.0|2.4258|10.1105|||Log Rank||||
1641086|NCT01915914|3015386|Superiority or Other||Hazard Ratio (HR)|13.4993|||<|0.0001|2-Sided|95.0|4.1113|44.325|||Log Rank||||
1640979|NCT01918033|3015269|Superiority or Other||Difference in LS Means|-0.11||||0.119|2-Sided|95.0|-0.25|0.03|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Itching Nasal Symptom Sub-Score at Week 2||
1640980|NCT01918033|3015269|Superiority or Other||Difference in LS Means|0.04||||0.557|2-Sided|95.0|-0.1|0.18|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2||
1640981|NCT01918033|3015269|Superiority or Other||Difference in LS Means|0.04||||0.535|2-Sided|95.0|-0.09|0.18|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Nasal Congestion Nasal Symptom Sub-Score at Week 2||
1640982|NCT01918033|3015269|Superiority or Other||Difference in LS Means|0.03||||0.627|2-Sided|95.0|-0.1|0.17|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2||
1640983|NCT01918033|3015269|Superiority or Other||Difference in LS Means|-0.01||||0.895|2-Sided|95.0|-0.15|0.13|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Rhinorrhea Nasal Symptom Sub-Score at Week 2||
1640984|NCT01918033|3015269|Superiority or Other||Difference in LS Means|-0.1||||0.067|2-Sided|95.0|-0.22|0.01|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2||
1640985|NCT01918033|3015269|Superiority or Other||Difference in LS Means|-0.03||||0.547|2-Sided|95.0|-0.15|0.08|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change From Baseline in Sneezing Nasal Symptom Sub-Score at Week 2||
1640986|NCT01918033|3015270|Superiority or Other||Difference in LS Means|0.09||||0.685|2-Sided|95.0|-0.33|0.5|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 1||
1640987|NCT01918033|3015270|Superiority or Other||Difference in LS Means|0.12||||0.569|2-Sided|95.0|-0.29|0.53|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 1||
1640988|NCT01918033|3015270|Superiority or Other||Difference in LS Means|-0.46||||0.013|2-Sided|95.0|-0.82|-0.1|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Day 3||
1640989|NCT01918033|3015270|Superiority or Other||Difference in LS Means|-0.48||||0.01|2-Sided|95.0|-0.84|-0.11|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Day 3||
1640990|NCT01918033|3015273|Superiority or Other||Difference in LS Means|-0.08||||0.707|2-Sided|95.0|-0.48|0.32|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 2||
1640991|NCT01918033|3015273|Superiority or Other||Difference in Least Squares (LS) Means|-0.09||||0.661|2-Sided|95.0|-0.49|0.31|||Constrained Longitudinal Data Analysis|Model with terms for visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable|Difference in LS Means for Change from Baseline in TNSS at Week 2||
1640992|NCT01917773|3015280|Superiority or Other|||||||0.807|||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 45 minutes. Values were considered to be significant if P <0.05.|
1640993|NCT01917773|3015280|Superiority or Other|||||||0.552|||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 30 minutes. Values were considered to be significant if P <0.05.|
1640994|NCT01917773|3015280|Non-Inferiority or Equivalence|"Reported MIs and SDs in healthy volunteers from an adult study were used to calculate sample size (1). A sample size of 13 patients was deemed adequate to detect a 25% change in MI with 80% power.~Reference: Rao SS, Kavelock R, Beaty J, Ackerson K, et al. Effects of fat and carbohydrate meals on colonic motor response. Gut. Feb 2000;46(2):205-211."||||||0.087|||||||Wilcoxon signed rank test|||The Wilcoxon signed rank test was used to analyze change in MI at 15 minutes. Values were considered to be significant if P <0.05.|
1640995|NCT01917214|3015316|Superiority or Other|||||||0.0308|||||||Log Rank||||
1640996|NCT01917006|3015321|Superiority||Least square mean difference|0.12||||0.38||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 10|
1640997|NCT01917006|3015321|Superiority||Least square mean difference|-0.12||||0.628||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 10|
1640998|NCT01917006|3015321|Superiority||Least square mean difference|-0.07||||0.572||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 10|
1641087|NCT01915732|3015397|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1641088|NCT01915732|3015398|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1640999|NCT01917006|3015321|Superiority||Least square mean difference|-0.37||||0.843||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 10|
1641000|NCT01917006|3015321|Superiority||Least square mean difference|0.35||||0.192||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 10|
1641001|NCT01917006|3015321|Superiority||Least square mean difference|0.16||||0.36||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 10|
1641002|NCT01917006|3015321|Superiority||Least square mean difference|0.16||||0.34||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 8|
1641003|NCT01917006|3015321|Superiority||Least square mean difference|-0.09||||0.592||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 8|
1641004|NCT01917006|3015321|Superiority||Least square mean difference|-0.07||||0.571||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 8|
1641005|NCT01917006|3015321|Superiority||Least square mean difference|-0.39||||0.849||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 8|
1641006|NCT01917006|3015321|Superiority||Least square mean difference|0.34||||0.205||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 8|
1641007|NCT01917006|3015321|Superiority||Least square mean difference|0.22||||0.308||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 8|
1641008|NCT01917006|3015321|Superiority||Least square mean difference|0.23||||0.274||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 6|
1641009|NCT01917006|3015321|Superiority||Least square mean difference|0.0||||0.495||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 6|
1641010|NCT01917006|3015321|Superiority||Least square mean difference|0.01||||0.495||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 6|
1641011|NCT01917006|3015321|Superiority||Least square mean difference|-0.28||||0.774||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 6|
1641012|NCT01917006|3015321|Superiority||Least square mean difference|0.47||||0.126||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 6|
1641013|NCT01917006|3015321|Superiority||Least square mean difference|0.35||||0.215||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 6|
1641014|NCT01917006|3015321|Superiority||Least square mean difference|0.4||||0.149||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 4|
1641015|NCT01917006|3015321|Superiority||Least square mean difference|0.17||||0.321||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 4|
1641016|NCT01917006|3015321|Superiority||Least square mean difference|0.12||||0.377||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 4|
1641017|NCT01917006|3015321|Superiority||Least square mean difference|-0.04||||0.543||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 4|
1641778|NCT01890746|3017567|Superiority||Odds Ratio (OR)|0.5281||||0.3224|2-Sided|95.0|0.1084|2.2086|||Cochran-Mantel-Haenszel||||
1641018|NCT01917006|3015321|Superiority||Least square mean difference|0.56||||0.087||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 4|
1641019|NCT01917006|3015321|Superiority||Least square mean difference|0.5||||0.127||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 4|
1641020|NCT01917006|3015321|Superiority||Least square mean difference|0.45||||0.113||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 2|
1641021|NCT01917006|3015321|Superiority||Least square mean difference|0.3||||0.199||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 2|
1641022|NCT01917006|3015321|Superiority||Least square mean difference|0.16||||0.33||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 2|
1641023|NCT01917006|3015321|Superiority||Least square mean difference|0.07||||0.417||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 2|
1641024|NCT01917006|3015321|Superiority||Least square mean difference|0.77||||0.025||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 2|
1641025|NCT01917006|3015321|Superiority||Least square mean difference|0.59||||0.079||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 2|
1641026|NCT01917006|3015322|Superiority||Least square mean difference|-2.57||||0.517||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 12|
1641027|NCT01917006|3015322|Superiority||Least square mean difference|-41.31||||0.756||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 12|
1641028|NCT01917006|3015322|Superiority||Least square mean difference|-40.18||||0.741||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 12|
1641029|NCT01917006|3015322|Superiority||Least square mean difference|-55.14||||0.823||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 12|
1641030|NCT01917006|3015322|Superiority||Least square mean difference|84.09||||0.101||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 12|
1641031|NCT01917006|3015322|Superiority||Least square mean difference|-14.76||||0.584||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 12|
1641032|NCT01917006|3015322|Superiority||Least square mean difference|-4.33||||0.526||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 10|
1641033|NCT01917006|3015322|Superiority||Least square mean difference|-40.68||||0.741||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 10|
1641034|NCT01917006|3015322|Superiority||Least square mean difference|-30.81||||0.681||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 10|
1641035|NCT01917006|3015322|Superiority||Least square mean difference|-52.81||||0.799||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 10|
1641036|NCT01917006|3015322|Superiority||Least square mean difference|102.44||||0.071||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 10|
1641089|NCT01915732|3015399|Superiority or Other||Mean Difference (Final Values)|-0.07|||<|0.001|2-Sided|95.0|-0.1|-0.03|||ANCOVA||Statistical data for the category=Total.||
1641037|NCT01917006|3015322|Superiority||Least square mean difference|-12.14||||0.565||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 10|
1641038|NCT01917006|3015322|Superiority||Least square mean difference|-0.18||||0.501||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 8|
1641039|NCT01917006|3015322|Superiority||Least square mean difference|-35.72||||0.712||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 8|
1641040|NCT01917006|3015322|Superiority||Least square mean difference|-27.74||||0.662||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 8|
1641041|NCT01917006|3015322|Superiority||Least square mean difference|-48.65||||0.778||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 8|
1641042|NCT01917006|3015322|Superiority||Least square mean difference|111.27||||0.058||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 8|
1641043|NCT01917006|3015322|Superiority||Least square mean difference|-5.94||||0.532||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 8|
1641044|NCT01917006|3015322|Superiority||Least square mean difference|17.76||||0.394||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 6|
1641045|NCT01917006|3015322|Superiority||Least square mean difference|-16.58||||0.604||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 6|
1641046|NCT01917006|3015322|Superiority||Least square mean difference|-10.06||||0.561||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 6|
1641047|NCT01917006|3015322|Superiority||Least square mean difference|-27.62||||0.67||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 6|
1641048|NCT01917006|3015322|Superiority||Least square mean difference|136.96||||0.026||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 6|
1641049|NCT01917006|3015322|Superiority||Least square mean difference|14.12||||0.424||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 6|
1641050|NCT01917006|3015322|Superiority||Least square mean difference|36.8||||0.281||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 4|
1641051|NCT01917006|3015322|Superiority||Least square mean difference|1.32||||0.491||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 4|
1641052|NCT01917006|3015322|Superiority||Least square mean difference|6.47||||0.459||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 4|
1641053|NCT01917006|3015322|Superiority||Least square mean difference|-6.2||||0.541||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 4|
1641054|NCT01917006|3015322|Superiority||Least square mean difference|148.86||||0.015||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 4|
1641055|NCT01917006|3015322|Superiority||Least square mean difference|33.05||||0.322||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 vs Placebo at Week 4|
1641090|NCT01915732|3015399|Superiority or Other||Mean Difference (Final Values)|-0.09|||<|0.001|2-Sided|95.0|-0.14|-0.04|||ANCOVA||Statistical data for the category=NIL.||
1641056|NCT01917006|3015322|Superiority||Least square mean difference|45.42||||0.203||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 6 vs Placebo at Week 2|
1641057|NCT01917006|3015322|Superiority||Least square mean difference|18.48||||0.362||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 5 vs Placebo at Week 2|
1641058|NCT01917006|3015322|Superiority||Least square mean difference|24.23||||0.328||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 4 vs Placebo at Week 2|
1641059|NCT01917006|3015322|Superiority||Least square mean difference|12.73||||0.404||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 3 vs Placebo at Week 2|
1641060|NCT01917006|3015322|Superiority||Least square mean difference|170.21||||0.002||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 2 vs Placebo at Week 2|
1641061|NCT01917006|3015322|Superiority||Least square mean difference|55.33||||0.184||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline average IELT as the covariate.|ANCOVA|||OnabotulinumtoxinA Dose 1 versus (vs) Placebo at Week 2|
1641062|NCT01917006|3015323|Superiority||Least square mean difference|0.15||||0.343||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA||||
1641063|NCT01917006|3015323|Superiority||Least square mean difference|-0.13||||0.645||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA||||
1641064|NCT01917006|3015323|Superiority||Least square mean difference|-0.14||||0.647||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA||||
1641065|NCT01917006|3015323|Superiority||Least square mean difference|-0.39||||0.861||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA||||
1641066|NCT01917006|3015323|Superiority||Least Square Mean Difference|0.25||||0.263||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from the ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate.|ANCOVA||||
1641067|NCT01917006|3015323|Superiority||Least square mean difference|0.11||||0.393||||||Least square mean and one-sided p-value of mean difference vs placebo for each active OnabotulinumtoxinA dose level is calculated from analysis of covariance (ANCOVA) Model with treatment as fixed effect and baseline geometric mean IELT as covariate.|ANCOVA||||
1641068|NCT01916980|3015329|Superiority or Other||||||<|0.001|||||||Longitudinal Data Analysis|Model includes terms of visit, group and visit by group interaction; visit is treated as a categorical variable||Analysis of the change from Baseline in LS mean for the Desloratadine: Dermal Pruritus group|
1641069|NCT01916980|3015329|Superiority or Other||||||<|0.001|||||||Longitudinal Data Analysis|Model includes terms of visit, group and visit by group interaction; visit is treated as a categorical variable||Analysis of the change from Baseline in least squares (LS) mean for the Desloratadine: Eczema/Dermatitis group|
1641070|NCT01916967|3015340|Superiority or Other||Difference in LS means|-1.13|||<|0.001|2-Sided|95.0|-1.66|-0.61|||Constrained Longitudinal Data Analysis|Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable||Difference in LS means of Desloratadine 10 mg and Placebo|
1641071|NCT01916967|3015340|Superiority or Other||Difference in LS means|-1.17|||<|0.001|2-Sided|95.0|-1.69|-0.65|||Constrained Longitudinal Data Analysis|Model with terms of visit, visit-by-treatment, visit-by-age strata, visit-by-severity interactions; visit treated as a categorical variable||Difference in least squares (LS) means of Desloratadine 5 mg and Placebo|
1641072|NCT01916226|3015367|Superiority or Other||Least Squares Mean Difference|-0.3|Standard Error of the Mean|-0.3||0.278|2-Sided|95.0|-0.7|0.2||Estimating the standard deviation of CFB in rTNSS over 2 weeks to be approximately 2.6, a two-sample t-test with α=0.05 suggests that a sample size of 144 participants per arm would provide 90% power to show a difference of 1.0 between treatments.|ANCOVA||||
1641073|NCT01915914|3015375|Superiority or Other|||||||0.2237||||||Week 32, Total VAS Score|Wilcoxon (Mann-Whitney)||||
1641074|NCT01915914|3015375|Superiority or Other|||||||0.0394||||||Week 20, Total VAS Score|Wilcoxon (Mann-Whitney)||||
1641075|NCT01915914|3015375|Superiority or Other|||||||0.11||||||Week 32, AP|Wilcoxon (Mann-Whitney)||||
1641076|NCT01915914|3015375|Superiority or Other|||||||0.1375||||||Week 32, ET/L|Wilcoxon (Mann-Whitney)||||
1641077|NCT01915914|3015375|Superiority or Other|||||||0.2799||||||Week 32, CA|Wilcoxon (Mann-Whitney)||||
1641078|NCT01915914|3015375|Superiority or Other|||||||0.081||||||Week 20, AP|Wilcoxon (Mann-Whitney)||||
1641079|NCT01915914|3015375|Superiority or Other|||||||0.0042||||||Week 20, ET/L|Wilcoxon (Mann-Whitney)||||
1641080|NCT01915914|3015375|Superiority or Other|||||||0.701||||||Week 20, CA|Wilcoxon (Mann-Whitney)||||
1641081|NCT01915914|3015380|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1641082|NCT01915914|3015381|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1641083|NCT01915914|3015383|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1641091|NCT01915732|3015399|Superiority or Other||Mean Difference (Final Values)|-0.04|||<|0.025|2-Sided|95.0|-0.07|0.0|||ANCOVA||Statistical data for the category=IL.||
1641092|NCT01915732|3015400|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.003|2-Sided|95.0|-0.09|-0.02|||ANCOVA||Statisticial data for the category=Total.||
1641093|NCT01915732|3015400|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.004|2-Sided|95.0|-0.12|-0.02|||ANCOVA||Statistical data for the category=NIL.||
1641094|NCT01915732|3015400|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.08|2-Sided|95.0|-0.06|0.0|||ANCOVA||Statistical data for the category=IL.||
1641095|NCT01915732|3015401|Superiority or Other||Mean Difference (Final Values)|-3.4||||0.002|2-Sided|95.0|-5.5|-1.2|||ANCOVA||Statistical data for the category=NIL.||
1641096|NCT01915732|3015401|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.028|2-Sided|95.0|-2.0|-0.1|||ANCOVA||Statistical data for the category=IL.||
1641097|NCT01915732|3015402|Superiority or Other||Mean Difference (Final Values)|-3.4||||0.004|2-Sided|95.0|-5.7|-1.1|||ANCOVA||Statistical data for the category=NIL.||
1641098|NCT01915732|3015402|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.077|2-Sided|95.0|-1.8|0.1|||ANCOVA||Statistical data for the category=IL.||
1641099|NCT01915732|3015403|Superiority or Other|||||||0.013|||||||Cochran-Mantel-Haenszel||||
1641100|NCT01915732|3015404|Superiority or Other|||||||0.018|||||||Cochran-Mantel-Haenszel||||
1641101|NCT01915732|3015405|Superiority or Other||Mean Difference (Final Values)|-4.6|||<|0.001|2-Sided|95.0|-7.3|-1.9|||ANCOVA||||
1641102|NCT01915732|3015406|Superiority or Other||Mean Difference (Final Values)|-4.5||||0.002|2-Sided|95.0|-7.4|-1.6|||ANCOVA||||
1641103|NCT01915173|3015410|Superiority or Other|||||||0.33|||||||Regression, Logistic|||All 4 arms were combined to compare the Placebo groups to the Supplement groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.|
1641104|NCT01915173|3015410|Superiority or Other|||||||0.01|||||||Regression, Logistic|||All 4 arms were combined to compare the Standard Interview groups to the Expanded Interview groups. We calculated that we had 45-74% power to detect a 30-40% difference in responders between groups in the pre-specified primary outcome measure, the percent of subjects with a 50% or greater improvement in GERD symptom severity.|
1641105|NCT01914926|3015413|Non-Inferiority or Equivalence|Chi-Square test||||||0.0001|||||||Chi-squared|||We estimated a sample size of 200 patients assigned in a 1:1 ratio to receive diltiazem and metoprolol would achieve 80% power to detect non-inferiority using a one-sided two sample t-test. The margin of equivalence is -10.|
1641106|NCT01914757|3015419|Superiority or Other||Mean Difference (Final Values)|0.24||||0.019|2-Sided|95.0|0.04|0.45|||Mixed Models Analysis|Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.|||
1641107|NCT01914757|3015419|Superiority or Other||Mean Difference (Final Values)|0.16||||0.119|2-Sided|95.0|-0.04|0.37|||Mixed Models Analysis|Model includes treatment, baseline AQLQ score, region, use of OCS, visit, visit by treatment.|||
1641108|NCT01914757|3015423|Superiority or Other||Rate Ratio|1.23||||0.538|2-Sided|95.0|0.64|2.35|||negative binomial|Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS|||
1641109|NCT01914757|3015423|Superiority or Other||Rate Ratio|0.93||||0.837|2-Sided|95.0|0.48|1.82|||negative binomial|Model includes treatment, region, any prior exacerbation resulting ER/Hospitalization, use of OCS|||
1641110|NCT01914757|3015424|Superiority or Other||Hazard Ratio (HR)|0.73||||0.018|2-Sided|95.0|0.55|0.95|||Regression, Cox|Model includes treatment, region, number of exacerbations in the previous year, use of OCS||Time to first asthma exacerbation|
1641111|NCT01914757|3015424|Superiority or Other||Hazard Ratio (HR)|0.61|||<|0.001|2-Sided|95.0|0.46|0.8|||Regression, Cox|Model includes treatment, region, number of exacerbations in the previous year, use of OCS||Time to first Exacerbation|
1641112|NCT01914757|3015425|Superiority or Other||Odds Ratio (OR)|0.65||||0.023|2-Sided|95.0|0.45|0.95|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with >=1 asthma exacerbation|
1641113|NCT01914757|3015425|Superiority or Other||Odds Ratio (OR)|0.46|||<|0.001|2-Sided|95.0|0.31|0.69|||Cochran-Mantel-Haenszel|Controlling for region, number of exacerbations in the previous year, use of OCS||Proportion of patients with >=1 asthma exacerbation|
1641114|NCT01914757|3015426|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.449|2-Sided|95.0|-0.37|0.16|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.|||
1641115|NCT01914757|3015426|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.078|2-Sided|95.0|-0.51|0.03|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.|||
1641116|NCT01914757|3015427|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.008|2-Sided|95.0|-0.44|-0.07|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.|||
1641117|NCT01914757|3015427|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.043|2-Sided|95.0|-0.38|-0.01|||Mixed Models Analysis|Model includes treatment, baseline ACQ-6 score, region, use of OCS, visit, and visit by treatment.|||
1641118|NCT01914757|3015428|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.146|2-Sided|95.0|-0.08|0.01|||Mixed Models Analysis|Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.|||
1641119|NCT01914757|3015428|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.4|2-Sided|95.0|-0.06|0.03|||Mixed Models Analysis|Model includes treatment, baseline prop of nights with nocturnal wakening, region, use of OCS, visit, and visit by treatment.|||
1641120|NCT01914757|3015429|Superiority or Other||Mean Difference (Final Values)|21.22||||0.004|2-Sided|95.0|6.65|35.79|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.||Evening PEF Change from Baseline to Week 56|
1641121|NCT01914757|3015429|Superiority or Other||Mean Difference (Final Values)|17.54||||0.018|2-Sided|95.0|3.07|32.0|||Mixed Models Analysis|Model includes treatment, baseline evening PEF, region, use of OCS, visit, and visit by treatment.||Evening PEF Change from Baseline to Week 56|
1641122|NCT01914757|3015429|Superiority or Other||Mean Difference (Final Values)|15.27||||0.037|2-Sided|95.0|0.9|29.64|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.||Morning PEF Change from Baseline to Week 56|
1641123|NCT01914757|3015429|Superiority or Other||Mean Difference (Final Values)|15.86||||0.029|2-Sided|95.0|1.59|30.12|||Mixed Models Analysis|Model includes treatment, baseline morning PEF, region, use of OCS, visit, and visit by treatment.||Morning PEF Change from Baseline to Week 56|
1641124|NCT01914757|3015430|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.209|2-Sided|95.0|-1.29|0.28|||Mixed Models Analysis|Model includes treatment, baseline Asthma medication use, region, use of OCS, visit, and visit by treatment.|||
1641125|NCT01914757|3015430|Superiority or Other||Mean Difference (Final Values)|0.21||||0.603|2-Sided|95.0|-0.58|0.99|||Mixed Models Analysis|Model includes treatment, baseline Asthma rescue medication use, region, use of OCS, visit, and visit by treatment.|||
1641126|NCT01914757|3015431|Superiority or Other||Mean Difference (Final Values)|0.01||||0.966|2-Sided|95.0|-0.28|0.29|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.|||
1641127|NCT01914757|3015431|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.287|2-Sided|95.0|-0.44|0.13|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.|||
1641128|NCT01914757|3015432|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.019|2-Sided|95.0|-0.43|-0.04|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.|||
1641129|NCT01914757|3015432|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.224|2-Sided|95.0|-0.32|0.07|||Mixed Models Analysis|Model includes treatment, baseline Asthma symptom score, region, use of OCS, visit, and visit by treatment.|||
1641130|NCT01914757|3015433|Superiority or Other||Mean Difference (Final Values)|-0.015||||0.786|2-Sided|95.0|-0.127|0.096|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit|||
1641131|NCT01914757|3015433|Superiority or Other||Mean Difference (Final Values)|0.064||||0.268|2-Sided|95.0|-0.049|0.176|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit|||
1641132|NCT01914757|3015434|Superiority or Other||Mean Difference (Final Values)|0.116||||0.01|2-Sided|95.0|0.028|0.204|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit|||
1641133|NCT01914757|3015434|Superiority or Other||Mean Difference (Final Values)|0.125||||0.005|2-Sided|95.0|0.037|0.213|||Mixed Models Analysis|Model includes treatment, baseline pre-BD FEV1, region, use of OCS, visit, and treatment by visit|||
1641134|NCT01914757|3015435|Superiority or Other||Rate Ratio|0.6||||0.005|2-Sided|95.0|0.42|0.86|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids.|||
1641135|NCT01914757|3015435|Superiority or Other||Rate Ratio|0.64||||0.015|2-Sided|95.0|0.45|0.92|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids|||
1641136|NCT01914757|3015436|Superiority or Other||Rate Ratio|0.72||||0.019|2-Sided|95.0|0.54|0.95|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids.|||
1641137|NCT01914757|3015436|Superiority or Other||Rate Ratio|0.64||||0.002|2-Sided|95.0|0.49|0.85|||Negative Binomial|Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids|||
1641138|NCT01913483|3015517|Superiority|||||||0.9458||||||The primary endpoint analysis was to assess the superiority of bivalirudin versus UFH in BARC ≥3 bleeds within the 48 hours post study drug initiation or at hospital discharge, whichever occurred first.|Chi-squared|||Assuming a bleeding event rate of 5.0% in the heparin control treatment group and 3.2% in the bivalirudin group (36% relative risk reduction, a sample size of 3900 participants was to provide more than 80% power with a two-tailed alpha level of 0.05). This estimate took into consideration that the interim efficacy analysis was to be performed when approximately 70% of participants were enrolled using the O’Brien-Fleming alpha spending function.|
1641139|NCT01913353|3015572|Superiority|Predefined threshold of clinical relevance for the area attenuation ratio (AAR): 40%|Area attenuation ratio (AAR)|97.9|||||2-Sided|95.0|96.6|98.3|||||The AAR, i.e. the reduction in MLA [1 – MLA ratio (Group 1/Group 2)] after scarification was to be significantly above 40%. The MLA ratio and the corresponding 95% CI were based on the Hodges-Lehmann estimate of the shift for log-transformed MLAs.||
1641140|NCT01913353|3015573|Non-Inferiority|The non-inferiority margin to show that Group 1 (after 2 doses of MVA-BN) is non-inferior to Group 2 (after 1 dose of ACAM2000) in terms of PRNT GMTs at the respective peak visit (Week 6 in Group 1 / Week 4 in Group 2) was predefined as ‘1/2 (i.e. 0.5)’ for the GMT ratio (Group 1 / Group 2).|GMT Ratio (Group 1 / Group 2)|1.935|||||2-Sided|95.0|1.562|2.397|||||||
1641141|NCT01911780|3015678|Superiority or Other||Adjusted Mean|2.3|Standard Error of the Mean|1.9|||2-Sided|95.0|-1.5|6.1|||||Model includes baseline SBP as a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.||
1641142|NCT01911780|3015679|Superiority or Other||Adjusted Mean|-0.4|Standard Error of the Mean|1.4|||2-Sided|95.0|-3.1|2.3|||||As a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.||
1641143|NCT01911780|3015681|Superiority or Other||Odds Ratio (OR)|3.1||||0.0052|2-Sided|95.0|1.4|7.1||Additional information, the p-value is not adjusted for multiplicity.|Regression, Logistic|Non-completers considered failures (NCF) was used as the imputation method.|Exact 95 % confidence interval by Clopper and Pearson. Logistic regression includes treatment and center.||
1641144|NCT01911780|3015682|Superiority or Other||Adjusted mean, comparison|-8.6|Standard Error of the Mean|2.1|<|0.0001|2-Sided|95.0|-12.7|-4.5||Additional information, the p-value is not adjusted for multiplicity.|LOCF-ANCOVA||Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.||
1641172|NCT01910402|3015778|Superiority or Other (legacy)|||||||0.002||||||Week 24|Wilcoxon (Mann-Whitney)||||
1641173|NCT01910402|3015778|Superiority or Other (legacy)||||||<|0.001||||||Week 12|Wilcoxon (Mann-Whitney)||||
1641145|NCT01911780|3015683|Superiority or Other||Adjusted mean, comparison|-7.5|Standard Error of the Mean|1.1|<|0.0001|2-Sided|95.0|-9.7|-5.3|||LOCF-ANCOVA|Last observation carried forward (LOCF) was used as the imputation method|Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.||
1641146|NCT01911689|3015684|Superiority or Other|||||||0.629|||||||t-test, 2 sided||||
1641147|NCT01911689|3015685|Superiority or Other|||||||0.071|||||||t-test, 2 sided|||compare the T2* value between the moderate and severe AP according to MRSI|
1641148|NCT01911689|3015685|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||compare the T2* value between the mild and severe AP|
1641149|NCT01911689|3015685|Superiority or Other|||||||0.0111|||||||t-test, 2 sided|||compare the T2* value in the mild and moderate AP according to MRSI|
1641150|NCT01911689|3015685|Superiority or Other||||||<|0.01|||||||ANOVA|||Analysis of variance (ANOVA) was used to assess the differences in the T2* value between the mild, moderate, and severe AP groups according to the MRSI score.|
1641151|NCT01911689|3015686|Superiority or Other|||||||0.05|||||||t-test, 2 sided|||The independent T test was used to determine the differences for the T2* value between the edematous AP and necrotizing AP|
1641152|NCT01911689|3015687|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|||The independent T test was used to determine the differences for the T2* value between the Control group and AP group.|
1641153|NCT01911442|3015697|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.24||0.2402|2-Sided||||||Mixed Models Analysis||||
1641154|NCT01911442|3015697|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.25||0.1755|2-Sided||||||Mixed Models Analysis||This is due to rounding. the LSM for Lurasidone 20 mg/d at week 6 was -1.069 vs -0.734 for placebo group. So the LSM of the treatment difference between Lurasidone 20 mg/d and placebo was 0.335 if 3 decimals are reported.||
1641155|NCT01911442|3015698|Superiority or Other||Mean Difference (Final Values)|-1.9|Standard Error of the Mean|2.09||0.3592|2-Sided|95.0|-6.1|2.2|||Mixed Models Analysis|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures.|
1641156|NCT01911442|3015698|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|2.15||0.5463|2-Sided|95.0|-5.6|3.0|||Mixed Models Analysis|||LS Mean, LS mean difference and the associated 95% Cl and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).|
1641157|NCT01911429|3015706|Superiority or Other||LS mean difference (SE)|-0.42||||0.0015|2-Sided|95.0|-0.67|-0.16|||LS mean difference (SE)|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).|
1641158|NCT01911429|3015706|Superiority or Other||LS mean difference (SE)|-0.47||||0.0003|2-Sided|95.0|-0.73|-0.22|||LS mean difference (SE)|||LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM).|
1641159|NCT01911429|3015707|Superiority or Other||LS mean difference (SE)|-7.7||||0.0006|2-Sided|95.0|-12.1|-3.4|||LS mean difference (SE)|||"The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.~LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM)."|
1641160|NCT01911429|3015707|Superiority or Other||LS mean difference (SE)|-8.0||||0.0003|2-Sided|95.0|-12.4|-3.7|||LS mean difference (SE)|||"The sample size was estimated to provide at least 85% power to reject at least one of the null hypotheses of no difference between placebo and lurasidone doses.~LS Mean, LS mean difference, and the associated 95% CI and p-value for change from baseline are based on Mixed Model for Repeated Measures (MMRM)."|
1641161|NCT01911351|3015717|Superiority or Other||kappa statistic|0.88|||<|0.001|2-Sided|||||A priori threshold for statistical significance: p< or = 0.05|Chi-squared|||A kappa statistic was performed for 75% of the group to assess inter-rater agreement of the perception of the success of the procedure.|
1641162|NCT01911260|3015735|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Deviation|2.0|<|0.05|2-Sided|95.0|||||t-test, 2 sided|In intragroup of supplementation (zinc or placebo) we used the t-test for dependent samples in order to compare growth over time.||"Null Hypothesis: There isn't difference in the HAZ mean difference between children with Normal Height who received zinc amino acid or placebo.~We attributed α=0.05, β=0.20, and power=0.80."|
1641163|NCT01911260|3015735|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Deviation|2.0|<|0.05|2-Sided|95.0|||||t-test, 2 sided|In intragroup of supplementation (zinc or placebo) we used the t-test for dependent samples in order to compare growth over time.||"Null Hypothesis: There isn't difference in the HAZ mean difference between children with Growth Deficit who received zinc amino acid or placebo.~We attributed α=0.05, β=0.20, and power=0.80."|
1641164|NCT01911169|3015748|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||This study was conducted to determine the effect size for in change in FMD at 16 weeks with 25(OH) therapy. For change in FMD at 16 weeks with 25(OH)D repletion, based on this effect size, to detect significant differences between 2 groups, assuming 1) normally distributed data, 2) the same effect size, 3) alpha= 0.05, and 4) a power of 0.8, 35 patients in each group would be required. Therefore, this was designed as a pilot to determine effect size.|
1641165|NCT01911169|3015748|Other||Cohen's d|0.68|||>||2-Sided|||||||||Effect size of primary outcome was calculated|
1641166|NCT01910519|3015764|Other|||||||0.0067|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M114.0-TBA at day 1 with MN titers at day 42|
1641167|NCT01910519|3015764|Other|||||||0.0411|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M58-B cell development/activation at day 1 with MN titers at day 42|
1641168|NCT01910519|3015764|Other|||||||0.0465|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M74-transcriptional targets of glucocorticoid receptor at day 1 with MN titers at day 42|
1641169|NCT01910519|3015764|Other|||||||0.0368|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M115-cytokines-receptors cluster at day 1 with MN titers at day 42|
1641170|NCT01910519|3015764|Other|||||||0.0039|||||||ANOVA|||Correlation of vaccine-induced blood transcription modules (BTMs) M183-TBA at day 1 with MN titers at day 42|
1641171|NCT01910402|3015778|Superiority or Other (legacy)|||||||0.007||||||Week 48|Wilcoxon (Mann-Whitney)||||
1641175|NCT01910402|3015780|Superiority or Other (legacy)||Ratio of ratio|0.852|||<|0.0001|2-Sided|95.0|0.794|0.914|||ANCOVA||Vitamin D ratio of Week 48 result over Baseline||
1641176|NCT01910402|3015780|Superiority or Other (legacy)||Ratio of ratio|0.655|||<|0.0001|2-Sided|95.0|0.609|0.706|||ANCOVA||Type 1 Collagen C-Telopeptide ratio of Week 48 result over Baseline||
1641177|NCT01910402|3015780|Superiority or Other (legacy)||Ratio of ratio|0.629|||<|0.001|2-Sided|95.0|0.581|0.68|||ANCOVA||Osteocalcin ratio of Week 48 result over Baseline||
1641178|NCT01910402|3015780|Superiority or Other (legacy)||Ratio of ratio|0.693|||<|0.001|2-Sided|95.0|0.647|0.741|||ANCOVA||PTP ratio of Week 48 result over Baseline||
1641179|NCT01910402|3015780|Superiority or Other (legacy)||Ratio of ratio|0.729|||<|0.001|2-Sided|95.0|0.683|0.779|||ANCOVA||BSAP ratio of Week 48 result over Baseline||
1641180|NCT01910402|3015790|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.106||||0.3165|2-Sided|95.0|-0.313|0.101|||Multiple Imputed Dataset - MAR||||
1641181|NCT01910402|3015791|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.026||||0.7053|2-Sided|95.0|-0.159|0.107|||Multiple Imputed Dataset - MAR||||
1641182|NCT01910402|3015806|Non-Inferiority or Equivalence (legacy)|Hypothesis was to show that the antiviral effect of the DTG/ABC/3TC FDC administered QD was non-inferior to QD ATV+RTV+TDF/FTC FDC. Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -12%|Adjusted difference in proportion|10.5||||0.005|2-Sided|95.0|3.1|17.8||If the primary and PP analyses both demonstrated non-inferiority, then as per pre-specified analysis, superiority of DTG/ABC/3TC FDC versus ATV+RTV+TDF/FTC FDC was tested in the ITT-E population at the 2-sided 5% level of significance.|Cochran-Mantel-Haenszel||||
1641183|NCT01910116|3015861|Superiority or Other|||||||0.06|||||||Chi-squared||||
1641184|NCT01910116|3015862|Superiority or Other|||||||0.017|||||||Chi-squared||||
1641185|NCT01910116|3015863|Superiority or Other|||||||0.022|||||||Chi-squared||||
1641186|NCT01910116|3015864|Superiority or Other|||||||0.036|||||||Chi-squared||||
1641187|NCT01910116|3015865|Superiority or Other|||||||0.683|||||||Fisher Exact||||
1641188|NCT01910116|3015866|Superiority or Other|||||||1|||||||Fisher Exact||||
1641189|NCT01910116|3015867|Superiority or Other|||||||0.485|||||||Chi-squared||||
1641190|NCT01910116|3015868|Superiority or Other|||||||0.378|||||||Chi-squared||||
1641191|NCT01910116|3015869|Superiority or Other|||||||0.252|||||||Wilcoxon (Mann-Whitney)||||
1641192|NCT01910116|3015870|Superiority or Other|||||||0.604|||||||Wilcoxon (Mann-Whitney)||||
1641193|NCT01910116|3015871|Superiority or Other|||||||0.062|||||||Wilcoxon (Mann-Whitney)||||
1641194|NCT01910116|3015872|Superiority or Other|||||||0.493|||||||Wilcoxon (Mann-Whitney)||||
1641195|NCT01910116|3015873|Superiority or Other|||||||0.186|||||||Wilcoxon (Mann-Whitney)||||
1641196|NCT01910116|3015874|Superiority or Other|||||||0.006|||||||Wilcoxon (Mann-Whitney)||||
1641197|NCT01910116|3015875|Superiority or Other|||||||0.66|||||||Wilcoxon (Mann-Whitney)||||
1641198|NCT01910116|3015876|Superiority or Other|||||||0.042|||||||Wilcoxon (Mann-Whitney)||||
1641199|NCT01910116|3015877|Superiority or Other|||||||0.126|||||||Wilcoxon (Mann-Whitney)||||
1641200|NCT01910116|3015878|Superiority or Other|||||||0.128|||||||Wilcoxon (Mann-Whitney)||||
1641201|NCT01910116|3015879|Superiority or Other|||||||0.124|||||||Wilcoxon (Mann-Whitney)||||
1641202|NCT01910116|3015880|Superiority or Other|||||||0.174|||||||Wilcoxon (Mann-Whitney)||||
1641203|NCT01910116|3015881|Superiority or Other|||||||0.221|||||||Wilcoxon (Mann-Whitney)||||
1641204|NCT01910116|3015882|Superiority or Other|||||||0.049|||||||Wilcoxon (Mann-Whitney)||||
1641205|NCT01910116|3015883|Superiority or Other|||||||0.021|||||||Wilcoxon (Mann-Whitney)||||
1641206|NCT01910116|3015884|Superiority or Other|||||||0.031|||||||Wilcoxon (Mann-Whitney)||||
1641207|NCT01910116|3015885|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1641208|NCT01910116|3015887|Superiority or Other|||||||0.097|||||||Wilcoxon (Mann-Whitney)||||
1641209|NCT01910116|3015888|Superiority or Other|||||||0.122|||||||Wilcoxon (Mann-Whitney)||||
1641210|NCT01910116|3015889|Superiority or Other|||||||0.347|||||||Wilcoxon (Mann-Whitney)||||
1641211|NCT01910116|3015890|Superiority or Other|||||||0.194|||||||Wilcoxon (Mann-Whitney)||||
1641212|NCT01910116|3015891|Superiority or Other|||||||0.229|||||||Wilcoxon (Mann-Whitney)||||
1641213|NCT01910116|3015892|Superiority or Other|||||||0.728|||||||Wilcoxon (Mann-Whitney)||||
1641214|NCT01910116|3015893|Superiority or Other|||||||0.014|||||||Wilcoxon (Mann-Whitney)||||
1641215|NCT01910116|3015894|Superiority or Other|||||||0.053|||||||Wilcoxon (Mann-Whitney)||||
1641216|NCT01910116|3015895|Superiority or Other|||||||0.011|||||||Wilcoxon (Mann-Whitney)||||
1641217|NCT01910116|3015896|Superiority or Other|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Assuming that an improvement in AUSCAN pain score of >10 is clinically meaningful, and assuming an alpha level of 0.05 (two-tailed), a power of 0.80, and a dropout rate of 20%, the sample size calculation revealed that 220 patients should be enrolled.|
1641218|NCT01909011|3015985|Superiority or Other|||||||0.016|||||||t-test, 2 sided||||
1641219|NCT01909011|3015986|Superiority or Other|||||||0.066|||||||t-test, 2 sided||||
1641220|NCT01909011|3015987|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1641221|NCT01908907|3016009|Superiority or Other||Mean Difference (Net)|0.016|Standard Error of the Mean|0.008||0.048|2-Sided||||||Regression, Linear|This is a complex regression model including linear and quadratic growth and interactions as specified above.||Linear mixed models were used to explore growth over time (weight, length and head circumference). These models included a random effect for intercepts and slopes to account for subject specific growth over time as well as a random effect for possible correlation between twins and triplets present in the data set. Fixed effects included both a linear and quadratic time effect, GA at birth, treatment group, full feeds (yes/no), and interactions. Non-significant interactions were eliminated.|
1641336|NCT01907828|3016142|Superiority||Mean Difference (Final Values)|7.4|Standard Deviation|22.9||0.2177|2-Sided|95.0|-4.8|19.6|||Paired Student's t-test|||Change in OSBP at 24 months|
1641222|NCT01908907|3016010|Superiority or Other||Median Difference (Net)|13.5|Standard Error of the Mean|6.5||0.07|2-Sided|95.0|0.2|28.7|||Regression, Linear|Outcome was transformed using a natural logarithm transformation. Models included gestational age group since the randomization was blocked.|Since analyzed on the log scale, estimates provide are % change rather than absolute change between group.|All analyses used the intent-to-treat study population. A linear mixed model was used to assess differences in time to full feeds, days on study drug, and gestational age at discharge. These models included a random effect for multiples, which was maintained in the model after testing. Fixed effects included treatment and GA group for time to full feeds and days on study drug and treatment effect for gestational age at discharge.|
1641223|NCT01908829|3016020|Superiority||Odds Ratio (OR)|1.55|||<|0.001|2-Sided|95.0|1.24|1.94|||Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641224|NCT01908829|3016020|Superiority||Odds Ratio (OR)|1.64|||<|0.001|2-Sided|95.0|1.3|2.07|||Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641225|NCT01908829|3016020|Superiority||Odds Ratio (OR)|1.41|||=|0|2-Sided|95.0|1.11|1.79|||Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641226|NCT01908829|3016020|Superiority||Odds Ratio (OR)|1.28|||=|0|2-Sided|95.0|0.99|1.66|||Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641227|NCT01908829|3016021|Superiority||Odds Ratio (OR)|1.43|||=|0|2-Sided|95.0|1.11|1.84||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641228|NCT01908829|3016021|Superiority||Odds Ratio (OR)|1.5|||=|0|2-Sided|95.0|1.15|1.96||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641229|NCT01908829|3016021|Superiority||Odds Ratio (OR)|1.44|||=|0|2-Sided|95.0|1.12|1.84||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641230|NCT01908829|3016021|Superiority||Odds Ratio (OR)|1.42|||=|0|2-Sided|95.0|1.13|1.79||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641231|NCT01908829|3016022|Superiority||Odds Ratio (OR)|1.5|||=|0|2-Sided|95.0|1.17|1.91||p<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641232|NCT01908829|3016022|Superiority||Odds Ratio (OR)|1.64|||<|0.001|2-Sided|95.0|1.27|2.13||p<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641233|NCT01908829|3016022|Superiority||Odds Ratio (OR)|1.51|||=|0|2-Sided|95.0|1.18|1.93||p<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641234|NCT01908829|3016022|Superiority||Odds Ratio (OR)|1.44|||=|0|2-Sided|95.0|1.14|1.82||p<0.05 indicates superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641235|NCT01908829|3016023|Superiority||Odds Ratio (OR)|1.75|||<|0.001|2-Sided|95.0|1.34|2.3||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641236|NCT01908829|3016023|Superiority||Odds Ratio (OR)|1.96|||<|0.001|2-Sided|95.0|1.47|2.61||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641337|NCT01907828|3016142|Superiority||Mean Difference (Final Values)|0.5|Standard Deviation|11.0||0.8019|2-Sided|95.0|-3.7|4.7|||Paired Student's t-test|||Change in ODBP at 24 months|
1641237|NCT01908829|3016023|Superiority||Odds Ratio (OR)|1.69|||<|0.001|2-Sided|95.0|1.31|2.18||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641238|NCT01908829|3016023|Superiority||Odds Ratio (OR)|1.49|||=|0|2-Sided|95.0|1.18|1.88||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641239|NCT01908829|3016024|Superiority||Odds Ratio (OR)|1.29|||=|0|2-Sided|95.0|1.02|1.64||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641240|NCT01908829|3016024|Superiority||Odds Ratio (OR)|1.37|||=|0|2-Sided|95.0|1.07|1.76||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641241|NCT01908829|3016024|Superiority||Odds Ratio (OR)|1.37|||=|0|2-Sided|95.0|1.06|1.76||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641242|NCT01908829|3016024|Superiority||Odds Ratio (OR)|1.15|||=|0|2-Sided|95.0|0.88|1.5||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641243|NCT01908829|3016025|Superiority||Odds Ratio (OR)|1.47|||=|0|2-Sided|95.0|1.17|1.84||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641244|NCT01908829|3016025|Superiority||Odds Ratio (OR)|1.44|||=|0|2-Sided|95.0|1.14|1.82||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641245|NCT01908829|3016025|Superiority||Odds Ratio (OR)|1.56|||<|0.001|2-Sided|95.0|1.23|1.98||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641246|NCT01908829|3016025|Superiority||Odds Ratio (OR)|1.24|||=|0|2-Sided|95.0|0.95|1.63||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641247|NCT01908829|3016026|Superiority||Odds Ratio (OR)|1.51|||<|0.001|2-Sided|95.0|1.2|1.9||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||EoT odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641248|NCT01908829|3016026|Superiority||Odds Ratio (OR)|1.54|||=|0|2-Sided|95.0|1.21|1.95||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 12 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641249|NCT01908829|3016026|Superiority||Odds Ratio (OR)|1.57|||<|0.001|2-Sided|95.0|1.25|1.98||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 8 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641250|NCT01908829|3016026|Superiority||Odds Ratio (OR)|1.48|||<|0.001|2-Sided|95.0|1.19|1.84||p<0.05 indicated superiority in favor of treatment group with highest response.|Regression, Logistic|||Week 4 odds ratios, 95% Two sided CIs for Odds ratios and p-values were from a logistic regression model including treatment group, sex, age group (<65, >=65 years), 4-week incontinence episode reduction group, geographic region as factors and baseline value as covariate.|
1641251|NCT01908829|3016028|Superiority||LS Means|-0.3|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641252|NCT01908829|3016028|Superiority||LS Means|-0.3|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.4|-0.2||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641253|NCT01908829|3016028|Superiority||LS Means|-0.2|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641254|NCT01908829|3016028|Superiority||LS Means|-0.2|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.4|-0.1||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Difference of adjusted mean was calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641255|NCT01908829|3016029|Superiority||LS Means|0.4|Standard Error of the Mean|0.1|=|0|2-Sided|95.0|0.2|0.6||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641256|NCT01908829|3016029|Superiority||LS Means|0.5|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|0.3|0.7||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641257|NCT01908829|3016029|Superiority||LS Means|0.3|Standard Error of the Mean|0.1|=|0|2-Sided|95.0|0.0|0.5||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641258|NCT01908829|3016029|Superiority||LS Means|0.4|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|0.2|0.6||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as the 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641259|NCT01908829|3016030|Superiority||LS Means|2.48|Standard Error of the Mean|0.85|=|0|2-Sided|95.0|0.81|4.15||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641260|NCT01908829|3016030|Superiority||LS Means|2.62|Standard Error of the Mean|0.87|=|0|2-Sided|95.0|0.92|4.31||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641261|NCT01908829|3016030|Superiority||LS Means|1.09|Standard Error of the Mean|0.85|=|0|2-Sided|95.0|-0.57|2.76||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641338|NCT01907828|3016142|Superiority||Mean Difference (Final Values)|0.6|Standard Deviation|22.3||0.882|2-Sided|95.0|-7.9|9.1|||Paired Student's t-test|||Change in OSBP at 24 months|
1641339|NCT01907828|3016143|Superiority||Mean Difference (Final Values)|-5.4|Standard Deviation|15.8||0.2076|2-Sided|95.0|-14.2|3.4|||Paired Student's t-test|||Change in ODBP at 12 months|
1641262|NCT01908829|3016030|Superiority||LS Means|1.73|Standard Error of the Mean|0.83|=|0|2-Sided|95.0|0.1|3.36||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641263|NCT01908829|3016031|Superiority||LS Means|1.86|Standard Error of the Mean|1.02|=|0|2-Sided|95.0|-0.15|3.87||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641264|NCT01908829|3016031|Superiority||LS Means|2.26|Standard Error of the Mean|1.05|=|0|2-Sided|95.0|0.2|4.32||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641265|NCT01908829|3016031|Superiority||LS Means|1.61|Standard Error of the Mean|1.0|=|0|2-Sided|95.0|-0.36|3.58||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641266|NCT01908829|3016031|Superiority||LS Means|0.54|Standard Error of the Mean|0.96|=|0|2-Sided|95.0|-1.35|2.43||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641267|NCT01908829|3016032|Superiority||LS Means|3.28|Standard Error of the Mean|1.03|=|0|2-Sided|95.0|1.27|5.29||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641268|NCT01908829|3016032|Superiority||LS Means|3.61|Standard Error of the Mean|1.05|=|0|2-Sided|95.0|1.54|5.67||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641269|NCT01908829|3016032|Superiority||LS Means|2.5|Standard Error of the Mean|1.0|=|0|2-Sided|95.0|0.55|4.46||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641270|NCT01908829|3016032|Superiority||LS Means|1.94|Standard Error of the Mean|0.96|=|0|2-Sided|95.0|0.05|3.83||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641271|NCT01908829|3016033|Superiority||LS Means|4.29|Standard Error of the Mean|1.07|<|0.001|2-Sided|95.0|2.2|6.39||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641340|NCT01907828|3016143|Superiority|Change in Office Systolic Blood Pressure (OSBP) at 12 months.|Mean Difference (Final Values)|2.0|Standard Deviation|30.0||0.7999|2-Sided|95.0|-14.6|18.6|||Paired Student's t-test||||
1641341|NCT01907828|3016143|Superiority||Mean Difference (Final Values)|-0.4|Standard Deviation|11.8||0.8489|2-Sided|95.0|-4.6|3.8|||Paired Student's t-test|||Change in Office Diastolic Blood Pressure (ODBP) at 12 months|
1641272|NCT01908829|3016033|Superiority||LS Means|4.71|Standard Error of the Mean|1.1|<|0.001|2-Sided|95.0|2.55|6.87||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641273|NCT01908829|3016033|Superiority||LS Means|3.35|Standard Error of the Mean|1.05|=|0|2-Sided|95.0|1.29|5.4||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641274|NCT01908829|3016033|Superiority||LS Means|2.9|Standard Error of the Mean|0.96|=|0|2-Sided|95.0|1.02|4.78||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641275|NCT01908829|3016034|Superiority||LS Means|3.15|Standard Error of the Mean|0.92|=|0|2-Sided|95.0|1.35|4.95||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641276|NCT01908829|3016034|Superiority||LS Means|3.49|Standard Error of the Mean|0.94|<|0.001|2-Sided|95.0|1.65|5.33||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641277|NCT01908829|3016034|Superiority||LS Means|2.31|Standard Error of the Mean|0.89|=|0|2-Sided|95.0|0.56|4.06||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641278|NCT01908829|3016034|Superiority||LS Means|1.92|Standard Error of the Mean|0.83|=|0|2-Sided|95.0|0.29|3.55||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641279|NCT01908829|3016035|Superiority||LS Means|-4.96|Standard Error of the Mean|0.98|<|0.001|2-Sided|95.0|-6.88|-3.04||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641280|NCT01908829|3016035|Superiority||LS Means|-5.59|Standard Error of the Mean|1.0|<|0.001|2-Sided|95.0|-7.56|-3.62||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641281|NCT01908829|3016035|Superiority||LS Means|-4.5|Standard Error of the Mean|0.97|<|0.001|2-Sided|95.0|-6.4|-2.6||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641342|NCT01907828|3016143|Superiority||Mean Difference (Final Values)|2.6|Standard Deviation|24.4||0.5399|2-Sided|95.0|-6.0|11.3|||Paired Student's t-test|||Change in OSBP at 12 months.|
1641343|NCT01907828|3016144|Superiority||Mean Difference (Final Values)|-10.33|Standard Deviation|8.53||0.0015|2-Sided|95.0|-15.75|-4.91|||Paired Student's t-test|||Change in ADBP at 24 months|
1641282|NCT01908829|3016035|Superiority||LS Means|-2.89|Standard Error of the Mean|0.91|=|0|2-Sided|95.0|-4.68|-1.1||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicated superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs & p-value were generated from ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors & baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641283|NCT01908829|3016041|Superiority||Rate Ratio|0.94|Standard Error of the Mean|0.04|=|0|2-Sided|95.0|0.86|1.03||p<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, & p-value for number of nocturia episodes during 3-day diary between combination & solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region & 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.|
1641284|NCT01908829|3016041|Superiority||Rate Ratio|0.93|Standard Error of the Mean|0.05|=|0|2-Sided|95.0|0.85|1.02||p<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, & p-value for number of nocturia episodes during 3-day diary between combination & solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region & 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.|
1641285|NCT01908829|3016041|Superiority||Rate Ratio|0.99|Standard Error of the Mean|0.04|=|0|2-Sided|95.0|0.9|1.07||p<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, & p-value for number of nocturia episodes during 3-day diary between combination & solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region & 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.|
1641286|NCT01908829|3016041|Superiority||Rate Ratio|1.0|Standard Error of the Mean|0.04|=|0|2-Sided|95.0|0.93|1.08||p<0.05 indicates superiority in favor of treatment group with lowest rate of nocturia episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, & p-value for number of nocturia episodes during 3-day diary between combination & solifenacin treatment calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region & 4-week incontinence episode reduction group as factors, log of (number of nocturia episodes/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.|
1641287|NCT01908829|3016042|Superiority||LS Means|-0.06|Standard Error of the Mean|0.05|=|0|2-Sided|95.0|-0.16|0.03||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EOT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641288|NCT01908829|3016042|Superiority||LS Means|-0.07|Standard Error of the Mean|0.05|=|0|2-Sided|95.0|-0.17|0.02||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641289|NCT01908829|3016042|Superiority||LS Means|-0.02|Standard Error of the Mean|0.05|=|0|2-Sided|95.0|-0.12|0.07||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641290|NCT01908829|3016042|Superiority||LS Means|-0.01|Standard Error of the Mean|0.05|=|0|2-Sided|95.0|-0.1|0.08||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641291|NCT01908829|3016043|Superiority||Rate Ratio|0.78|Standard Error of the Mean|0.08|=|0|2-Sided|95.0|0.66|0.92||p<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination & solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.|
1641344|NCT01907828|3016144|Superiority||Mean Difference (Final Values)|-8.58|Standard Deviation|12.41||0.0354|2-Sided|95.0|-16.47|-0.7|||Paired Student's t-test|||Change in ASBP at 24 months|
1641345|NCT01907828|3016144|Superiority||Mean Difference (Final Values)|-6.94|Standard Deviation|6.06||0.0002|2-Sided|95.0|-10.06|-3.83|||Paired Student's t-test|||Change in ADBP at 24 months|
1641292|NCT01908829|3016043|Superiority||Rate Ratio|0.79|Standard Error of the Mean|0.09|=|0|2-Sided|95.0|0.67|0.94||p<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination & solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.|
1641293|NCT01908829|3016043|Superiority||Rate Ratio|0.82|Standard Error of the Mean|0.08|=|0|2-Sided|95.0|0.7|0.95||p<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination & solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.|
1641294|NCT01908829|3016043|Superiority||Rate Ratio|0.97|Standard Error of the Mean|0.06|=|0|2-Sided|95.0|0.87|1.08||p<0.05 indicates superiority in favor of treatment group with lowest rate of pads used.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, and p-value for number of pads used during the 3-day diary between combination & solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of pads used/number of valid diary days) at baseline as covariate and log of number of valid diary days as the offset variable.|
1641295|NCT01908829|3016044|Superiority||LS Means|-0.31|Standard Error of the Mean|0.1|=|0|2-Sided|95.0|-0.51|-0.12||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group & geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641296|NCT01908829|3016044|Superiority||LS Means|-0.28|Standard Error of the Mean|0.1|=|0|2-Sided|95.0|-0.47|-0.08||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group & geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641297|NCT01908829|3016044|Superiority||LS Means|-0.34|Standard Error of the Mean|0.11|=|0|2-Sided|95.0|-0.55|-0.13||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group & geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641298|NCT01908829|3016044|Superiority||LS Means|-0.26|Standard Error of the Mean|0.1|=|0|2-Sided|95.0|-0.46|-0.07||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group & geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641299|NCT01908829|3016045|Superiority||LS Means|-0.54|Standard Error of the Mean|0.15|<|0.001|2-Sided|95.0|-0.83|-0.25||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641300|NCT01908829|3016045|Superiority||LS Means|-0.52|Standard Error of the Mean|0.15|=|0|2-Sided|95.0|-0.82|-0.22||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641301|NCT01908829|3016045|Superiority||LS Means|-0.64|Standard Error of the Mean|0.15|<|0.001|2-Sided|95.0|-0.93|-0.35||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641346|NCT01907828|3016144|Superiority||Mean Difference (Final Values)|-5.71|Standard Deviation|14.84||0.1326|2-Sided|95.0|-13.34|1.93|||Paired Student's t-test|||Change in ASBP at 24 months|
1641347|NCT01907828|3016145|Superiority||Mean Difference (Final Values)|-8.43|Standard Deviation|9.42||0.0052|2-Sided|95.0|-13.87|-2.99|||Paired Student's t-test|||Change in ADBP at 12 months|
1641779|NCT01890746|3017568|Superiority||Hazard Ratio (HR)|1.1||||0.6175|2-Sided|95.0|0.74|1.63|||Log Rank||||
1641302|NCT01908829|3016045|Superiority||LS Means|-0.45|Standard Error of the Mean|0.13|=|0|2-Sided|95.0|-0.72|-0.19||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641303|NCT01908829|3016046|Superiority||Rate Ratio|0.82|Standard Error of the Mean|0.09|=|0|2-Sided|95.0|0.69|0.97||p<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, and p-value for number of UI episodes during EoT 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.|
1641304|NCT01908829|3016046|Superiority||Rate Ratio|0.83|Standard Error of the Mean|0.09|=|0|2-Sided|95.0|0.69|0.99||p<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 12 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.|
1641305|NCT01908829|3016046|Superiority||Rate Ratio|0.74|Standard Error of the Mean|0.08|<|0.001|2-Sided|95.0|0.63|0.86||p<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 8 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.|
1641306|NCT01908829|3016046|Superiority||Rate Ratio|0.85|Standard Error of the Mean|0.05|=|0|2-Sided|95.0|0.76|0.94||p<0.05 indicates superiority in favor of treatment group with lowest rate of UI episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, and p-value for number of UI episodes during Week 4 3-day diary between combination and solifenacin treatment was calculated from a Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region and 4-week incontinence episode reduction group as factors, log of (number of UI episodes/number of valid diary days) at baseline as covariate and log of number of valid diary as the offset variable.|
1641307|NCT01908829|3016047|Superiority||LS Means|-0.27|Standard Error of the Mean|0.1|=|0|2-Sided|95.0|-0.47|-0.07||P-values for pairwise comparisons were from stratified rank ANCOVA model. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641308|NCT01908829|3016047|Superiority||LS Means|-0.26|Standard Error of the Mean|0.11|=|0|2-Sided|95.0|-0.47|-0.05||P-values for pairwise comparisons were from stratified rank ANCOVA model. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641309|NCT01908829|3016047|Superiority||LS Means|-0.45|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.65|-0.25||P-values for pairwise comparisons were from stratified rank ANCOVA model. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 8 djusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641310|NCT01908829|3016047|Superiority||LS Means|-0.35|Standard Error of the Mean|0.09|<|0.001|2-Sided|95.0|-0.54|-0.17||P-values for pairwise comparisons were from stratified rank ANCOVA model. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641311|NCT01908829|3016048|Superiority||LS Means|-0.44|Standard Error of the Mean|0.15|=|0|2-Sided|95.0|-0.73|-0.16||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641348|NCT01907828|3016145|Superiority||Mean Difference (Final Values)|-3.07|Standard Deviation|19.21||0.5599|2-Sided|95.0|-14.16|8.02|||Paired Student's t-test|||Change in ASBP at 12 months.|
1641349|NCT01907828|3016145|Superiority||Mean Difference (Final Values)|-5.82|Standard Deviation|7.45||0.0014|2-Sided|95.0|-9.12|-2.52|||Paired Student's t-test|||Change in ADBP at 12 months|
1641312|NCT01908829|3016049|Superiority||LS Means|11.52|Standard Error of the Mean|2.79|<|0.001|2-Sided|95.0|6.06|16.99||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641313|NCT01908829|3016049|Superiority||LS Means|12.38|Standard Error of the Mean|2.92|<|0.001|2-Sided|95.0|6.65|18.12||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641314|NCT01908829|3016049|Superiority||LS Means|11.19|Standard Error of the Mean|2.66|<|0.001|2-Sided|95.0|5.98|16.4||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641315|NCT01908829|3016049|Superiority||LS Means|3.86|Standard Error of the Mean|2.19|<|0.078|2-Sided|95.0|-0.43|8.16||P-values for pairwise comparisons were from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641316|NCT01908829|3016050|Superiority||Rate Ratio|0.82|Standard Error of the Mean|0.08|=|0|2-Sided|95.0|0.71|0.96||p<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||EoT rate ratio, 95% CIs, & p-value for number of incontinence episodes (IEs) during EoT 3-day diary between combination & solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region & 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate & log of number of valid diary days as the offset variable.|
1641317|NCT01908829|3016050|Superiority||Rate Ratio|0.82|Standard Error of the Mean|0.08|=|0|2-Sided|95.0|0.7|0.97||p<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 12 rate ratio, 95% CIs, & p-value for number of incontinence episodes (IEs) during Week 12 3-day diary between combination & solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region & 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate & log of number of valid diary days as the offset variable.|
1641318|NCT01908829|3016050|Superiority||Rate Ratio|0.75|Standard Error of the Mean|0.07|<|0.001|2-Sided|95.0|0.66|0.86||p<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 8 rate ratio, 95% CIs, & p-value for number of incontinence episodes (IEs) during Week 8 3-day diary between combination & solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region & 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate & log of number of valid diary days as the offset variable.|
1641319|NCT01908829|3016050|Superiority||Rate Ratio|0.87|Standard Error of the Mean|0.05|=|0|2-Sided|95.0|0.79|0.96||p<0.05 indicates superiority in favor of treatment group with lowest rate of incontinence episodes.|Mixed Effects Poisson|||Week 4 rate ratio, 95% CIs, & p-value for number of incontinence episodes (IEs) during Week 4 3-day diary between combination & solifenacin treatment was calculated from Mixed Effects Poisson (negative binomial) regression model including treatment group, sex, age group (<65, >=65 years), geographic region & 4-week IE reduction group as factors, log of (number of IEs/valid diary days) at baseline as covariate & log of number of valid diary days as the offset variable.|
1641320|NCT01908829|3016051|Superiority||LS Means|-0.45|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|-0.67|-0.22||P-values for pairwise comparisons are from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||EoT adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641321|NCT01908829|3016051|Superiority||LS Means|-0.47|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|-0.7|-0.23||P-values for pairwise comparisons are from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 12 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641350|NCT01907828|3016145|Superiority||Mean Difference (Final Values)|-5.86|Standard Deviation|15.21||0.0849|2-Sided|95.0|-12.61|0.88|||Paired Student's t-test|||Change in ASBP at 12 months|
1641351|NCT01907828|3016148|Superiority|||||||0.7663|||||||Wilcoxon signed-rank test||||
1641352|NCT01907828|3016149|Superiority|||||||0.2766|||||||Paired Student's t-test||||
1641322|NCT01908829|3016051|Superiority||LS Means|-0.42|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|-0.65|-0.19||P-values for pairwise comparisons are from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 8 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641323|NCT01908829|3016051|Superiority||LS Means|-0.26|Standard Error of the Mean|0.1|=|0|2-Sided|95.0|-0.47|-0.06||P-values for pairwise comparisons are from the ANCOVA model described above. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|ANCOVA|||Week 4 adjusted change from baseline values as well as 95% CIs and p-value were generated from an ANCOVA model with treatment group, sex, age group (<65, >=65 years), 4-week incontinence reduction group and geographic region as fixed factors and baseline value as a covariate. Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group.|
1641324|NCT01908829|3016052|Superiority||LS Means|-0.25|Standard Error of the Mean|0.11|=|0|2-Sided|95.0|-0.46|-0.03||P-values for pairwise comparisons are from the stratified rank ANCOVA model. p<0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 12 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.|
1641325|NCT01908829|3016052|Superiority||LS Means|-0.39|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.6|-0.18||P values for pairwise comparisons are from the stratified rank ANCOVA model. P < 0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 8 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.|
1641326|NCT01908829|3016052|Superiority||LS Means|-0.33|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.52|-0.14||P values for pairwise comparisons are from the stratified rank ANCOVA model. P < 0.05 indicates superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Week 4 differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% CIs are from an ANCOVA model with sex, age group (< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.|
1641327|NCT01908829|3016053|Superiority||Least Squares (LS) Means|-0.26|Standard Error of the Mean|0.11|=|0|2-Sided|95.0|-0.47|-0.05||P values for pairwise comparisons were from the stratified rank ANCOVA model. P < 0.05 indicated superiority in favor of treatment group with the largest improvement.|stratified rank ANCOVA|||Differences of adjusted means were calculated by subtracting adjusted mean of solifenacin monotherapy groups from adjusted mean of combination group based on ANCOVA model. Means (LS means) and 95% Confidence Intervals (CIs) are from an ANCOVA model with sex, age group (< 65, ≥ 65 years), geographic region, and 4-week incontinence episode reduction group as fixed factors and mean number of incontinence episodes per 24 hours at baseline as a covariate.|
1641328|NCT01908426|3016080|Superiority|||||||0.0086|||||||Cochran-Mantel-Haenszel||||
1641329|NCT01908426|3016081|Superiority||Hazard Ratio (HR)|0.44|||<|0.0001|2-Sided|95.0|0.36|0.52|||Log Rank|The Log Rank Test was stratified by etiology of disease, geographic region, presence of extrahepatic spread of disease and/or macrovascular invasion.|||
1641330|NCT01908426|3016082|Superiority||Hazard Ratio (HR)|0.76||||0.0049|2-Sided|95.0|0.63|0.92|||Log Rank|The Log-Rank Test was stratified by etiology of disease, geo. region, presence of extrahepatic spread of disease and/or macrovascular invasion.|||
1641331|NCT01908140|3016083|Non-Inferiority or Equivalence|non-inferiority limit -0.5 units|Mean Difference (Final Values)|-0.001|||>|0.05|2-Sided|95.0|-0.46|0.46|||MMRM|||The total sample size provided 81% nominal power to show that the lower bound of the two-sided 95 confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in transitional dyspnoea index (TDI) at 24 weeks is above -0,5|
1641332|NCT01908140|3016084|Non-Inferiority or Equivalence|non-inferiority margin=-0,055 L|Mean Difference (Final Values)|0.093|||<|0.001|2-Sided|95.0|0.063|0.123|||MMRM|If non-inferiority on the PP was achieved then switch to superiority was tested on the ITT.||This sample size of 900 had 90% power to show that the lower bound of the two-sided 95% confidence interval for the difference between Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg and SeretideTM AccuhalerTM (50/500 μg) in Peak FEV1 at 24 weeks is above -0,055 L|
1641333|NCT01907854|3016140|Superiority or Other||Treatment difference|-1.67|||<|0.0001|2-Sided|95.0|-2.34|-0.99|||Mixed Models Analysis|Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.||Change in body weight from baseline to the 26 weeks measurements was analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and >8.5%), metformin dose (<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the body weight at baseline as a covariate and all variables nested within week as a factor.|
1641334|NCT01907854|3016141|Superiority or Other||Treatment difference|-0.61|||<|0.0001|2-Sided|95.0|-0.82|-0.4|||Mixed Models Analysis|Superiority of liraglutide over sitagliptin was concluded if the 95% Confidence Interval for the treatment difference was entirely below 0%.||Changes in HbA1c from baseline to the 26 weeks measurements were analysed using MMRM, with treatment, baseline HbA1c level (≤8.5% and >8.5%), metformin dose (<1500 mg/day and ≥1500 mg/day), the interaction between baseline HbA1c level and metformin dose, and country as factors and the HbA1c value at baseline as a covariate, all variables nested within week as a factor.|
1641335|NCT01907828|3016142|Superiority||Mean Difference (Final Values)|-3.0|Standard Deviation|15.5||0.4502|2-Sided|95.0|-11.2|5.2|||Paired Student's t-test|||Change in ODBP at 24 months|
1641353|NCT01907828|3016153|Other|||||||0.22|||||||Log Rank|||Kaplan-Meier analysis performed to provide freedom from atrial fibrillation rates at one year for each randomization arm using date of ablation procedure to date of first event.|
1641354|NCT01907321|3016169|Superiority or Other|||||||0.519|||||||ANOVA||||
1641355|NCT01907321|3016170|Superiority or Other||Mean Difference (Final Values)|32.78|Standard Deviation|14.98||0.001|2-Sided||||||repeated measures ANOVA||||
1641356|NCT01907217|3016176|Superiority||Odds Ratio (OR)|0.59||||0.001|2-Sided|95.0|0.45|0.79|||Regression, Linear|generalized linear models with a binomial distribution and logit-link|||
1641357|NCT01907217|3016177|Superiority||Odds Ratio (OR)|0.59||||0.001|2-Sided|95.0|0.45|0.78|||Regression, Linear|Analyzed using a generalized linear models with a binomial distribution and logit-link.|||
1641358|NCT01907217|3016178|Superiority or Other||Odds Ratio (OR)|0.66||||0.001|2-Sided|95.0|0.51|0.85||As above|generalized linear models with a binomia|||The AMI-SF at end of treatment was analyzed using generalized linear models with a binomial distribution and logit-link. Post treatment AMI-SF measures provide the number of baseline items recalled after ECT; such “number of items recalled” variables were therefore modeled as arising from binomial distributions, with maximum number of possible recalls set to the number of items obtained at baseline.|
1641359|NCT01907217|3016179|Non-Inferiority or Equivalence|"The prespecified noninferiority margin was no more than a –4 point difference at the end of treatment between the bilateral and unilateral groups.~The predicted difference at the end of treatment was 1.08 (95% confidence interval [CI] = –1.67 to 3.84."|Mean Difference (Final Values)|1.08|||<|0.05|2-Sided|95.0|-1.67|3.84||Primary statistical analysis was assessment of difference in HAM-D scores between arms at end-of-treatment, supplemented by 95% CIs and this interval compared with the pre-specified noninferiority threshold (-4 points). The p-value was calculated.|Regression, Linear|A regression model was fitted to end-of-treatment HAM-D measures, with baseline HAM-D scores, trial arm, randomization stratifiers as covariates.|The prespecified noninferiority margin was no more than a –4-point difference at the end of treatment between bitemporal and unilateral groups. The predicted difference at the end of treatment was 1.08 (95% confidence interval [CI]=–1.67 to 3.84).|Based on a large bitemporal ECT series, we estimated that 69 patients were required per group to have 80% power to demonstrate, using a one-sided equivalence t test at 5% level, that the mean reduction in the 24-item HAM-D score following high-dose unilateral ECT was no more than 4 points (i.e., equivalent to 3 points on the 17-item HAM-D, deemed to be clinically relevant [30]) less than that achieved using bitemporal ECT.|
1641360|NCT01907113|3016194|Non-Inferiority or Equivalence|Ratio calculated as kidney failure divided by normal renal function|Geometric mean ratio|103.75|Standard Deviation|29.7|||2-Sided|95.0|81.18|132.61|||||Standard deviation is actually the geometric Coefficient of Variation [%].|No formal testing, investigation of relative bioavailability|
1641361|NCT01907113|3016194|Non-Inferiority or Equivalence|Ratio calculated as severe renal function divided by normal renal function|Geometric mean ratio|120.68|Standard Deviation|29.7|||2-Sided|90.0|94.42|154.25|||||Standard deviation is actually the geometric Coefficient of Variation [%].|No formal testing, investigation of relative bioavailability|
1641362|NCT01907113|3016194|Non-Inferiority or Equivalence|Ratio calculated as moderate renal function divided by normal renal function|Geometric mean ratio|102.27|Standard Deviation|29.7|||2-Sided|90.0|79.33|131.85|||||Standard deviation is actually the geometric Coefficient of Variation [%].|No formal testing, investigation of relative bioavailability|
1641363|NCT01907113|3016194|Non-Inferiority or Equivalence|Ratio calculated as mild renal function divided by normal renal function|Geometric mean ratio|118.83|Standard Deviation|29.7|||2-Sided|90.0|93.62|150.84|||||Standard deviation is actually the geometric Coefficient of Variation [%].|No formal testing, investigation of relative bioavailability|
1641364|NCT01907113|3016195|Non-Inferiority or Equivalence|Ratio calculated as kidney failure divided by normal renal function|Geometric mean ratio|148.29|Standard Deviation|25.6|||2-Sided|90.0|119.89|183.42|||||Standard deviation is actually the geometric Coefficient of Variation [%].|No formal testing, investigation of relative bioavailability|
1641365|NCT01907113|3016195|Non-Inferiority or Equivalence|Ratio calculated as severe renal function divided by normal renal function|Geometric mean ratio|166.29|Standard Deviation|25.6|||2-Sided|90.0|134.44|205.68|||||Standard deviation is actually the geometric Coefficient of Variation [%].|No formal testing, investigation of relative bioavailability|
1641366|NCT01907113|3016195|Non-Inferiority or Equivalence|Ratio calculated as moderate renal function divided by normal renal function|Geometric mean ratio|119.94|Standard Deviation|25.6|||2-Sided|90.0|96.25|149.47|||||Standard deviation is actually the geometric Coefficient of Variation [%].|No formal testing, investigation of relative bioavailability|
1641367|NCT01907113|3016195|Non-Inferiority or Equivalence|Ratio calculated as mild renal function divided by normal renal function|Geometric mean ratio|118.24|Standard Deviation|25.6|||2-Sided|90.0|96.17|145.38|||||Standard deviation is actually the geometric Coefficient of Variation [%].|No formal testing, investigation of relative bioavailability|
1641368|NCT01907100|3016196|Other||Odds Ratio (OR)|0.79||||0.7512|2-Sided|95.0|0.4|1.55||one-sided p-value|Regression, Logistic|Odds ratio and one−sided p−value are obtained from an un−adjusted logistic regression model (Nintedanib vs Placebo).|Odds ratio above 1 favours nintedanib.||
1641369|NCT01907100|3016197|Other||Odds Ratio (OR)|1.09||||0.3189|2-Sided|95.0|0.76|1.58||one-sided p-value|Regression, Logistic|Odds ratio and one−sided p−value are obtained from an un−adjusted logistic regression model (Nintedanib vs Placebo).|Odds ratio above 1 favours nintedanib.||Exact 95% CI by Clopper and Pearson.
1641370|NCT01907100|3016198|Other||Hazard Ratio (HR)|1.12||||0.7306|2-Sided|95.0|0.79|1.58||one-sided p-value|Proportional hazards model||Hazard ratio, confidence interval and p−value obtained from a non-stratified proportional hazards model.|"Phase III:~A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo).~If the hazard ratio is below 1 then it favours nintedanib."|
1641371|NCT01907100|3016198|Other||Hazard Ratio (HR)|0.782||||0.4132|2-Sided|95.0|0.433|1.412|||Proportional hazards mode||Hazard ratio, confidence interval and p−value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).|Phase II|
1641420|NCT01903993|3016365|Superiority or Other (legacy)||Difference in Response Rates|0.59|||=|0|2-Sided|95.0|-7.67|8.85|||Cochran-Mantel-Haenszel||||
1641996|NCT01884545|3018053|Superiority|||||||0.4673|||||||Regression, Linear||||
1641372|NCT01907100|3016199|Other||Hazard Ratio (HR)|1.01||||0.543|2-Sided|95.0|0.79|1.3||one-sided p-value|Proportional hazards model||Hazard ratio, confidence interval and p−value obtained from a non-stratified proportional hazards model.|"Phase III part:~A Cox proportional hazards model was fitted to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for the comparison of treatment arms (Nintedanib vs Placebo).~If the hazard ratio is below 1 then it favours nintedanib."|
1641373|NCT01907100|3016199|Other||Hazard Ratio (HR)|0.555||||0.0174|2-Sided|95.0|0.34|0.907|||Proportional hazards mode||Hazard ratio, confidence interval and p−value obtained from proportional hazards model stratified by tumour histology (epithelioid vs. biphasic).|Phase II Part|
1641374|NCT01907087|3016205|Other|"Subject rate of decline per 48 weeks is estimated: (baseline CLN2 score - last CLN2 score)/(time elapsed in units of 48 weeks).~P-value computed as a two-sided t-test for the hypothesis H0: Rate=2.0 points lost/48 weeks vs. H1: Rate not equal 2.0 points lost/48 weeks."|Slope|0.4|Standard Deviation|0.809|<|0.0001|2-Sided|95.0|0.05|0.75|||t-test, 2 sided|||Slopes Analysis using ITT Population: Estimated Rate of Decline (300 mg Dosing Period).|
1641375|NCT01907087|3016205|Other|Inference is by an exact binomial test of the null hypothesis H0: Prob(response) <= 0.50 vs. the alternative hypothesis H1: Prob(response) > 0.50, where Prob(response) denotes the population probability of a response. The confidence interval is an exact interval with significance level α=0.05.|Proportion of responders|0.87|||<|0.0002|2-Sided|95.0|0.66|0.97|||exact binomial test|||"Responder Analysis using ITT Population: Proportion of Subjects without an Unreversed Two-point Decline or Score of 0 in ML Scale Score at 48 Weeks.~A 'response' is defined as the absence of an unreversed two-point decline or score of 0 in the 0-to-6 point CLN2 score at 48 weeks."|
1641376|NCT01906866|3016215|Superiority||Mean Difference (Final Values)|-25.2|Standard Error of the Mean|9.787|=|0|2-Sided|95.0|-44.61|-5.8|||Mixed Models Analysis||||
1641377|NCT01906866|3016216|Superiority||Mean Difference (Final Values)|32.32|Standard Error of the Mean|15.1|=|0|2-Sided|95.0|2.38|62.26|||Mixed Models Analysis||||
1641378|NCT01906515|3016221|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1641379|NCT01906515|3016222|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1641380|NCT01906476|3016225|Superiority||ICER estimate|-152.55|||||2-Sided|95.0|-1143.09|1094.72||||||We calculated the ICER (Incremental cost-effectiveness ratio) estimate, computed using the difference in average cost between the two arms, divided by the difference in average Depression Free Days (DFD) as defined using QIDS (Quick Inventory of Depressive Symptomatology), between the two arms, Stepped Care minus Telephone Cognitive Behavior Therapy. The confidence interval was created using bootstrapping.|
1641381|NCT01906476|3016226|Non-Inferiority|Non-inferiority trials of pharmaceuticals have used 30% to 50% of the difference between treatment and control conditions to define non-inferiority margins. (Jones, Jarvis, Lewis, & Ebbutt, 1996; Nutt et al., 2008). A meta-analysis of CBT found an overall effect size of d=0.82.(Cuijpers, Smit, Bohlmeijer, Hollon, & Andersson, 2010). Using the midpoint of 40% for the acceptable criterion, we set d=0.33 as the non-inferiority criterion.|||||||||||||||||"Cohen's d and upper limits of one-sided 95% Confidence intervals for each time are as follows:~Mid-treatment -0.19 (95% upper limit= 0.06) End of treatment 0.03 (0.24) 3 months post treatment -0.02 (0.19) 6 months post treatment -0.07 (0.14)"
1641382|NCT01906372|3016227|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1641383|NCT01906372|3016228|Superiority or Other||Frequency of achieving primary endpoint|0.7|||||2-Sided||||||||||
1641384|NCT01905657|3016264|Superiority or Other (legacy)||Difference in Percentages|9.1||||0.00024|2-Sided|95.0|4.1|14.3|||Miettinen & Nurminen method|||In participants with PD-L1 positive tumors|
1641385|NCT01905657|3016264|Superiority or Other (legacy)||Difference in Percentages|8.7||||0.00045|2-Sided|95.0|3.6|13.9|||Miettinen & Nurminen method|||In participants with PD-L1 positive tumors|
1641386|NCT01905657|3016264|Superiority or Other (legacy)||Difference in Percentages|22.2|||<|1e-05|2-Sided|95.0|14.0|30.7|||Miettinen & Nurminen method|||In participants with strongly PD-L1 positive tumors|
1641387|NCT01905657|3016264|Superiority or Other (legacy)||Difference in Percentages|-2.3|||<|0.66608|2-Sided|95.0|-12.7|8.2|||Miettinen & Nurminen method||This is an adjusted risk difference estimated by stratified Miettinen & Nurminen method.|In participants with strongly PD-L1 positive tumors|
1641388|NCT01905657|3016267|Superiority or Other (legacy)||Hazard Ratio (HR)|0.79||||0.00462|2-Sided|95.0|0.66|0.94|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m^2|In participants with PD-L1 positive tumors|
1641389|NCT01905657|3016267|Superiority or Other (legacy)||Hazard Ratio (HR)|0.88||||0.06758|2-Sided|95.0|0.73|1.04|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m^2|In participants with PD-L1 positive tumors|
1641390|NCT01905657|3016267|Superiority or Other (legacy)||Hazard Ratio, log|0.59||||7e-05|2-Sided|95.0|0.45|0.78|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m^2|In participants with strongly PD-L1 positive tumors|
1641391|NCT01905657|3016267|Superiority or Other (legacy)||Hazard Ratio, log|0.58||||9e-05|2-Sided|95.0|0.43|0.77|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m^2|In participants with strongly PD-L1 positive tumors|
1641392|NCT01905657|3016268|Superiority or Other (legacy)||Hazard Ratio (HR)|0.61|||<|1e-05|2-Sided|95.0|0.49|0.75|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m^2|In participants with PD-L1 positive tumors|
1641393|NCT01905657|3016268|Superiority or Other (legacy)||Hazard Ratio (HR)|0.71|||<|0.00076|2-Sided|95.0|0.58|0.88|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m^2|In participants with PD-L1 positive tumors|
1641394|NCT01905657|3016268|Superiority or Other (legacy)||Hazard Ratio (HR)|0.5|||<|2e-05|2-Sided|95.0|0.36|0.7|||Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m^2|In participants with strongly PD-L1 positive tumors|
1641395|NCT01905657|3016268|Superiority or Other (legacy)||Hazard Ratio (HR)|0.54|||<|0.00024|2-Sided|95.0|0.38|0.77|||Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m^2|In participants with strongly PD-L1 positive tumors|
1641396|NCT01905553|3016269|Non-Inferiority or Equivalence|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.449|||||2-Sided|90.0|0.38|0.53|||||||
1641655|NCT01894230|3017282|Equivalence|Month 3|Slope|-0.0189|Standard Error of the Mean|0.3986||0.96|2-Sided||||||Regression, Linear||||
1641397|NCT01905553|3016270|Non-Inferiority or Equivalence|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.718|||||2-Sided|90.0|0.67|0.769|||||||
1641398|NCT01905553|3016271|Non-Inferiority or Equivalence|The magnitude effect of food on the pharmacokinetic parameters was evaluated by calculating the point estimate and 90% CIs between Treatment A (test treatment, fed) and Treatment B (reference treatment, fasted).|Ratio of Geometric LS Means|0.718|||||2-Sided|90.0|0.67|0.77|||||||
1641399|NCT01905540|3016275|Non-Inferiority or Equivalence|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Ratio of geometric LS means|1.344|||||2-Sided|90.0|1.135|1.592|||||||
1641400|NCT01905540|3016276|Non-Inferiority or Equivalence|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Geometric LS Means|1.233|||||2-Sided|90.0|1.07|1.422|||||||
1641401|NCT01905540|3016277|Non-Inferiority or Equivalence|The statistical comparison of log-transformed pharmacokinetic parameters between the single-dose treatment groups (Treatments AQ and SS) was based on the 90% CI for the ratio of the geometric means. If the 90% CI was entirely contained within the acceptance range of 0.8-1.25 then it was concluded that there was no statistically significant difference between treatments for the relevant parameter. Doses were normalized to the SSP-004184AQ (40mg/kg) dose prior to statistical analysis.|Ratio of geometric LS means|1.244|||||2-Sided|90.0|1.081|1.43|||||||
1641402|NCT01904864|3016283|Superiority||Mean Difference (Net)|1.0|||<|0.001|2-Sided|95.0|0.4|1.6|||Regression, Linear||Change at 12 weeks compared||
1641403|NCT01904773|3016287|Superiority or Other||Median Difference (Net)|1.34|Standard Error of the Mean|0.85||0.1198||||||Bonferroni-Holm compared with 0.025|ANCOVA|Each subject received each treatment multiple times in a crossover design|||
1641404|NCT01904773|3016287|Superiority or Other||Mean Difference (Net)|2.42|Standard Error of the Mean|0.9||0.0087||||||Bonferroni-Holm adjustment, compared with 0.025|ANCOVA|Each subject received each treatment multiple times in a crossover design||Comparison with placebo|
1641405|NCT01904604|3016306|Superiority or Other|||||||0.01||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.|
1641406|NCT01904604|3016306|Superiority or Other|||||||0.008||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.|
1641407|NCT01904604|3016306|Superiority or Other|||||||0.8||||||No adjustments were made to the p-value.|Wilcoxon (Mann-Whitney)|The two-sided t approximation was used.||The null hypothesis was that there was no difference between treatment groups.|
1641408|NCT01904604|3016310|Superiority or Other||Risk Difference (RD)|2.2||||0.48|2-Sided|2.2|-25.8|30.1||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic||||
1641409|NCT01904604|3016310|Superiority or Other||Risk Difference (RD)|36.0||||0.003|2-Sided|36.0|12.6|59.4||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.|
1641410|NCT01904604|3016310|Superiority or Other||Risk Difference (RD)|33.8||||0.005|2-Sided|33.8|10.2|57.5||A one-sided test was used with the a priori threshold for statistical significance of 0.0125. No adjustments were made to the p-value.|Barnard's statistic|||The null hypothesis was that there was no difference between treatment groups. Subjects who did not complete the Week 52 oral food challenge were counted as treatment failures.|
1641411|NCT01904071|3016347|Superiority or Other|||||||0.342|||||||ANOVA||||
1641412|NCT01904071|3016348|Superiority or Other||||||<|0.001|||||||ANOVA||||
1641413|NCT01904071|3016349|Superiority or Other||||||<|0.005|||||||ANOVA||||
1641414|NCT01904071|3016350|Superiority or Other||||||<|0.05|||||||ANOVA||||
1641415|NCT01904071|3016351|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1641416|NCT01904058|3016359|Superiority or Other||Least squares mean difference|-3.99||||0.438|2-Sided|95.0|-14.2|6.23||p-value (LUM001 LS Mean = Placebo LS Mean).|ANCOVA|||The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score was evaluated by ANCOVA using a GLM. The model included terms for treatment group, ALP level (strata), treatment group by ALP level interaction, and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95% confidence interval for the mean, were presented.|
1641417|NCT01904058|3016359|Superiority or Other||Least squares mean difference|-2.28||||0.6603|2-Sided|95.0|-12.59|8.03||p-value (LUM001 LS Mean = Placebo LS Mean).|ANCOVA|||The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score evaluated by analysis of covariance (ANCOVA) using generalized linear model (GLM). The model included terms for treatment group, alkaline phosphatase (ALP) level (strata), treatment group by ALP level interaction and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95 percentage (%) confidence interval for mean were presented.|
1641418|NCT01903993|3016363|Superiority or Other (legacy)||Hazard Ratio (HR)|0.32|||=|0|2-Sided|95.0|0.15|0.7|||Log rank (unstratified)|||HR were estimated by a unstratified Cox regression model.|
1641419|NCT01903993|3016364|Superiority or Other (legacy)||Hazard Ratio (HR)|0.92|||=|0|2-Sided|95.0|0.71|1.2|||Log rank (Stratified)|||HR were estimated by a Cox regression model. The two treatment comparison was based on a stratified log-rank test.|
1641421|NCT01903993|3016366|Superiority or Other (legacy)||Hazard Ratio (HR)|0.69|||=|0|2-Sided|95.0|0.52|0.92|||Log rank (Stratified)|||Hazard ratios (HR) were estimated by a Cox regression model.|
1641422|NCT01903876|3016367|Non-Inferiority or Equivalence|equivalence||||||0.042|||||||ANCOVA||||
1641423|NCT01903876|3016368|Non-Inferiority or Equivalence|equivalence||||||0.044|||||||ANCOVA||||
1641424|NCT01903863|3016369|Superiority|||||||0.95|||||||Wilcoxon (Mann-Whitney)||||
1641425|NCT01903863|3016370|Superiority|||||||0.12|||||||Wilcoxon (Mann-Whitney)||||
1641426|NCT01903863|3016371|Superiority|||||||0.8|||||||Wilcoxon (Mann-Whitney)||||
1641427|NCT01903863|3016372|Superiority|||||||0.37|||||||Wilcoxon (Mann-Whitney)||||
1641428|NCT01903863|3016373|Superiority|||||||0.8|||||||Wilcoxon (Mann-Whitney)||||
1641429|NCT01903863|3016374|Superiority|||||||0.004|||||||Wilcoxon (Mann-Whitney)||||
1641430|NCT01903863|3016375|Superiority|||||||0.5||||||Gastrointestinal hemorrhage|Fisher Exact||||
1641431|NCT01903863|3016375|Superiority|||||||0.7||||||Surgical bleed|Fisher Exact||||
1641432|NCT01903863|3016375|Superiority|||||||0.07||||||Intracranial hemorrhage|Fisher Exact||||
1641433|NCT01903863|3016376|Superiority|||||||0.39|||||||Wilcoxon (Mann-Whitney)||||
1641434|NCT01903811|3016381|Superiority|||||||0.113|||||||Cochran-Mantel-Haenszel|||Compare the rate of confirmed PR or better between treatment arms.|
1641435|NCT01903811|3016382|Superiority||Hazard Ratio (HR)|1.149||||0.284|2-Sided|80.0|0.841|1.571||Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.|Log Rank|One-sided stratified log rank test|||
1641436|NCT01903811|3016383|Superiority||Hazard Ratio (HR)|1.061||||0.384|2-Sided|80.0|0.821|1.37||Stratified by pre-specified randomization stratification factors: 1 - 3 prior therapies vs. 4-6 prior therapies and refractory to bortezomib vs. not refractory to bortezomib.|Log Rank|One-sided stratified log rank test|||
1641437|NCT01903460|3016404|Superiority or Other||LS mean difference from placebo|-0.019||||0.9547|2-Sided|95.0|-0.71|0.673|||ANCOVA|||Analysis of all doses of LUM001 for Observer ItchRO|
1641438|NCT01903460|3016404|Superiority or Other||LS mean difference from placebo|0.173||||0.632|2-Sided|95.0|-0.58|0.926|||ANCOVA|||Analysis of LUM001 280ug/kg/day for Observer ItchRO|
1641439|NCT01903460|3016404|Superiority or Other||LS mean difference from placebo|-0.21||||0.5966|2-Sided|95.0|-1.038|0.618|||ANCOVA|||Analysis of LUM001 140ug/kg/day for Observer ItchRO|
1641440|NCT01903460|3016404|Superiority or Other||LS mean difference from placebo|-0.073||||0.9203|2-Sided|95.0|-1.85|1.705|||ANCOVA|||Analysis of all doses of LUM001 for Patient ItchRO|
1641441|NCT01903460|3016404|Superiority or Other||LS mean difference from placebo|0.202||||0.7897|2-Sided|95.0|-1.647|2.052|||ANCOVA|||Analysis of LUM001 280ug/kg/day for Patient ItchRO|
1641442|NCT01903460|3016404|Superiority or Other||LS mean difference from placebo|-0.348||||0.6907|2-Sided|95.0|-2.468|1.772|||ANCOVA|||Analysis of LUM001 140ug/kg/day for Patient ItchRO|
1641443|NCT01903460|3016405|Superiority or Other||LS mean difference from placebo|31.8||||0.6917|2-Sided|95.0|-135.8|199.4|||ANCOVA|||Analysis of all doses of LUM001 for ALP|
1641444|NCT01903460|3016405|Superiority or Other||LS mean difference from placebo|11.9||||0.8835|2-Sided|95.0|-158.4|182.2|||ANCOVA|||Analysis of LUM001 280ug/kg/day for ALP|
1641445|NCT01903460|3016405|Superiority or Other||LS mean difference from placebo|51.7||||0.5748|2-Sided|95.0|-140.3|243.7|||ANCOVA|||Analysis of LUM001 140ug/kg/day for ALP|
1641446|NCT01903460|3016405|Superiority or Other||LS mean difference from placebo|4.1||||0.8081|2-Sided|95.0|-31.0|39.1|||ANCOVA|||Analysis of all doses of LUM001 for AST|
1641447|NCT01903460|3016405|Superiority or Other||LS mean difference from placebo|-15.8||||0.3914|2-Sided|95.0|-54.1|22.4|||ANCOVA|||Analysis of LUM001 280ug/kg/day for AST|
1641448|NCT01903460|3016405|Superiority or Other||LS mean difference from placebo|24.0||||0.2372|2-Sided|95.0|-17.5|65.5|||ANCOVA|||Analysis of LUM001 140ug/kg/day for AST|
1641449|NCT01903460|3016405|Superiority or Other||LS mean difference from placebo|32.2||||0.2235|2-Sided|95.0|-21.9|86.3|||ANCOVA|||Analysis of all doses of LUM001 for ALT|
1641450|NCT01903460|3016405|Superiority or Other||LS mean difference from placebo|7.8||||0.7827|2-Sided|95.0|-51.4|67.0|||ANCOVA|||Analysis of LUM001 280ug/kg/day for ALT|
1641451|NCT01903460|3016405|Superiority or Other||LS mean difference from placebo|56.7||||0.0783|2-Sided|95.0|-7.2|120.6|||ANCOVA|||Analysis of LUM001 140ug/kg/day for ALT|
1641452|NCT01903460|3016406|Superiority or Other||LS mean difference from placebo|-23.969||||0.6954|2-Sided|95.0|-151.969|104.031|||ANCOVA|||Analysis of all doses of LUM001|
1641453|NCT01903460|3016406|Superiority or Other||LS mean difference from placebo|-7.231||||0.9147|2-Sided|95.0|-148.726|134.264|||ANCOVA|||Analysis of LUM001 280ug/kg/day|
1641454|NCT01903460|3016406|Superiority or Other||LS mean difference from placebo|-40.707||||0.574|2-Sided|95.0|-191.679|110.265|||ANCOVA|||Analysis of LUM001 140ug/kg/day|
1641455|NCT01903356|3016410|Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis.||Comparison of FPG before and 24 weeks after administration of TrajentaDuo® Tablet treatment|The difference considered in the analysis is FPG values after drug administration minus FPG values before drug administration
1641456|NCT01903356|3016413|Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test has been used for this analysis.||Comparison of % of HbA1c before and 24 weeks after administration of TrajentaDuo® Tablet treatment.|The difference considered in the analysis is HbA1c values after drug administration minus HbA1c values before drug administration
1641457|NCT01903252|3016428|Other||Percentage|0.0|||||2-Sided|95.0|0.0|1.5|||||||
1641458|NCT01903252|3016429|Other||Percentage|44.9|||||2-Sided|95.0|38.5|51.3|||||||
1641459|NCT01903252|3016430|Other||Percentage|26.3|||||2-Sided|95.0|20.9|32.3|||||||
1641460|NCT01903252|3016431|Other||Percentage|60.1|||||2-Sided|95.0|53.6|66.3|||||||
1641461|NCT01903252|3016432|Other||Percentage|21.8|||||2-Sided|95.0|16.8|27.5|||||||
1641462|NCT01903252|3016433|Other||Mean Difference (Net)|-0.1||||0.099|2-Sided|95.0|-0.2|0.0|||t-test, 2 sided||||
1641463|NCT01903252|3016434|Other||Mean Difference (Net)|-0.1||||0.357|2-Sided|95.0|-0.2|0.1|||t-test, 2 sided||||
1641464|NCT01903252|3016435|Other||Mean Difference (Net)|0.0||||0.937|2-Sided|95.0|-0.1|0.1|||t-test, 2 sided||The apparent difference between the values in the table and the mean difference is due to rounding as defined in the SAP.||
1641465|NCT01903252|3016436|Other||Mean Difference (Net)|0.1||||0.455|2-Sided|95.0|-0.1|0.2|||t-test, 2 sided||The result of the mean difference is not corresponding to the values in the table due to rounding as specified in the Statistical Analysis Plan (SAP).||
1641466|NCT01903252|3016437|Other||Mean Difference (Net)|0.0||||0.987|2-Sided|95.0|-0.3|0.3|||t-test, 2 sided||||
1641467|NCT01903252|3016438|Other||Mean Difference (Net)|-0.1||||0.557|2-Sided|95.0|-0.5|0.3|||t-test, 2 sided||||
1641468|NCT01903252|3016439|Non-Inferiority or Equivalence|Non-inferiority|Risk Difference (RD)|-3.9||||0.042|2-Sided|95.0|-10.8|3.0|||Non-inferiority||||
1641469|NCT01903252|3016440|Non-Inferiority or Equivalence|Non-inferiority|Risk Difference (RD)|-3.7||||0.013|2-Sided|95.0|-9.2|1.8|||Non-inferiority||||
1641470|NCT01903252|3016441|Non-Inferiority or Equivalence|Non-inferiority|Risk Difference (RD)|-3.4||||0.031|2-Sided|95.0|-10.3|3.7|||Non-inferiortiy||||
1641471|NCT01903252|3016442|Non-Inferiority or Equivalence|Non-inferiority|Risk Difference (RD)|-2.9||||0.021|2-Sided|95.0|-9.8|4.0|||Non-inferiortiy||||
1641472|NCT01903252|3016443|Non-Inferiority or Equivalence|Non-inferiority|Risk Difference (RD)|-5.3||||0.068|2-Sided|95.0|-11.5|0.9|||Non-inferiority||||
1641473|NCT01903252|3016444|Non-Inferiority|Non-Inferiority|Risk Difference (RD)|-4.2||||0.048|2-Sided|95.0|-11.0|2.7|||Non-inferiority||||
1641474|NCT01903252|3016445|Non-Inferiority or Equivalence|Non-Inferiority|Risk Difference (RD)|-3.9||||0.042|2-Sided|95.0|-10.8|3.1|||Non-inferiortiy||||
1641475|NCT01903252|3016446|Non-Inferiority or Equivalence|Non-inferiority|Risk Difference (RD)|-4.8||||0.048|2-Sided|95.0|-10.9|1.4|||Non-inferiority||||
1641476|NCT01903252|3016447|Non-Inferiority or Equivalence|Non-inferiority|Risk Difference (RD)|-3.1||||0.026|2-Sided|95.0|-10.1|3.9|||Non-inferiority||||
1641477|NCT01903252|3016448|Non-Inferiority or Equivalence|non-inferiority|Risk Difference (RD)|-2.1|||<|0.001|2-Sided|95.0|-6.5|2.2|||Non-inferiority||||
1641478|NCT01903252|3016450|Superiority or Other||Percentag|75.3|||||2-Sided|95.0|69.4|80.6|||||||
1641479|NCT01903252|3016451|Non-Inferiority or Equivalence|Non-inferiority, pre-defined non-inferiority margin 10% A two-sided 95% confidence interval about the difference in proportions was constructed. If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.|Risk Difference (RD)|-2.2||||0.005|2-Sided|95.0|-8.1|3.8|||Non-inferiority|||If the lower limit of the confidence interval was no less than -10% it would be concluded that the test product is non-inferior to the comparator.|
1641480|NCT01903031|3016483|Other|||||||0.004||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Ethinyl Estradiol on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with ATV/r plus TDF and ≥1 NRTIs.|
1641481|NCT01903031|3016483|Other||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Ethinyl Estradiol on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with EFV plus ≥2 NRTIs.|
1641482|NCT01903031|3016484|Other||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Etonogestrel on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with ATV/r plus TDF and ≥1 NRTIs.|
1641483|NCT01903031|3016484|Other||||||<|0.001||||||No adjustments for multiple comparisons were made. Statistical significance was declared if p<0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: There is no difference in concentrations of Etonogestrel on day 21 between the control arm (NuvaRing and no ART) and NuvaRing with EFV plus ≥2 NRTIs.|
1641484|NCT01902303|3016514|Superiority or Other|||||||0.3835|||||||Chi-squared||||
1641485|NCT01902303|3016515|Superiority or Other||||||>|0.5|||||||Chi-squared||||
1641486|NCT01901874|3016524|Other||Cumulative probability|0.022|||||2-Sided|95.0|0.009|0.052|||||Kaplan-Meier product-limit method (Greenwood's formula for standard error)||
1641487|NCT01901874|3016525|Other||Cumulative probability|0.018|||||2-Sided|95.0|0.007|0.047|||||Kaplan-Meier product-limit method (Greenwood's formula for standard error)||
1641488|NCT01901874|3016533|Other|"Acceptable performance: favorably exclude PG=16.9% with 95.1% confidence.~Wa = expected weight (proportion) anatomic = 35% Pa = CEA expected anatomic MAE = 11% Wc = expected weight (proportion) comorbid = 65% Pc = CEA expected comorbid MAE = 14% D = noninferiority delta = 4%~PG = 0.35 x 11% + 0.65 x 14% + 4% = 16.9%"|Weighted binomial proportion|0.0448|Standard Error of the Mean|0.0241|<|1e-05|1-Sided|95.1||0.0846||A priori 1-sided alpha = 0.049 (from simulation) to ensure overall type-1 error rate ≤ 0.05.|Binomial test (normal approximation)||Weighted by expected fractions of anatomic and comorbid high risk subjects (35% and 65%, respectively). Standard error based on H0.|"Test null hypothesis of equal or greater proportion with 1-year MAE compared to a performance goal (PG).~H0: P ≥ 16.9% vs H1: P < 16.9%, where P is the true proportion of CAS subjects with 1-year MAE and 16.9% is the PG based on outcomes reported for patients treated with carotid endarterectomy (CEA).~N=280 subjects provide ≥90% power to exclude PG with 95.1% confidence if P=10.2% under H1."|
1641489|NCT01901809|3016536|Superiority||Mean Difference (Net)|-4.8|Standard Error of the Mean|4.8||0.33|2-Sided|95.0|-14.4|4.9|||t-test, 2 sided||||
1641490|NCT01901809|3016537|Superiority||Mean Difference (Net)|11.4|Standard Error of the Mean|4.7||0.018|2-Sided|95.0|2.0|20.8|||t-test, 2 sided||||
1641491|NCT01901575|3016554|Superiority or Other||Risk Difference (RD)|0.65|Standard Error of the Mean|0.75||0.05|2-Sided|0.15|0.65|0.8|||Fisher Exact|||"null hypothesis:~Remifentanil IVPCA sedation in patients undergoing ablation of the idiopathic ventricular tachycardia does not cause suppression of PVC's"|
1641492|NCT01901250|3016592|Superiority or Other|||||||0.25|||||||Permutation test|Adjusted for child's gender, caries burden at study entry, surface-years at risk, and study cohort.|||
1641615|NCT01895361|3017134|Other||Hazard Ratio (HR)|0.534|||=|0|2-Sided|95.0|0.329|0.866|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates||
1641493|NCT01901146|3016613|Other|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Ratio (RR)|1.2746||||0.0245|2-Sided|90.0|1.0673|1.5222|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.|
1641494|NCT01901146|3016613|Other|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Difference (RD)|8.0||||0.0253|2-Sided|90.0|2.1|13.9|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.|
1641495|NCT01901146|3016614|Other|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Ratio (RR)|1.1463||||0.0807|2-Sided|90.0|1.008|1.3035|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk ratio (ABP 980 / Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.|
1641496|NCT01901146|3016614|Other|Analyses of secondary endpoints were prespecified to be considered descriptive only.|Risk Difference (RD)|6.0||||0.1086|2-Sided|90.0|-0.2|12.2|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The analysis of risk difference (ABP 980 - Trastuzumab) estimated using a generalized linear model adjusted for the randomization stratification factors T-stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.|
1641497|NCT01901146|3016615|Equivalence|If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the risk ratio of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab estimated using a generalized linear model adjusted for stratification factors, with the margin of (0.7586, 1/0.7586). If the test of equivalence on the RD was not successful, the RR of pCR and 90% CI were considered to be descriptive.|Risk Ratio (RR)|1.1877||||0.043|2-Sided|90.0|1.0327|1.366|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||If the test of equivalence on the RD of pCR was successful, then equivalence was tested on the Risk Ratio (RR; ABP 980 / Trastuzumab) of pCR at a 2-sided significance level of 0.05 by comparing the 2-sided 90% CI of the RR of pCR between ABP 980 and trastuzumab, estimated using a generalized linear model adjusted for stratification factors: tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.|
1641498|NCT01901146|3016615|Equivalence|The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% CI of the risk difference of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%).|Risk Difference (RD)|7.3||||0.0508|2-Sided|90.0|1.2|13.4|||Generalized linear model|Generalized linear model adjusted for the randomization stratification factors.||The clinical equivalence between ABP 980 and trastuzumab was first evaluated by comparing the 2-sided 90% confidence interval (CI) of the Risk Difference (RD; ABP 980 - Trastuzumab) of pCR between ABP 980 and trastuzumab with a fixed margin of (-13%, 13%), estimated using a generalized linear model adjusted for stratification factors tumor (T)-stage, nodal status, hormone receptor status, planned paclitaxel dosing schedule, and geographic region.|
1641499|NCT01900665|3016644|Superiority||Mean Difference (Final Values)|-0.8||||0.095|2-Sided|95.0|-1.73|0.14|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate the denominator degrees of freedom.|||
1641500|NCT01900431|3016700|Superiority||Odds Ratio (OR)|1.07||||1|2-Sided|90.0|0.306|3.845||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using common odds ratio which came from CMH analysis adjusted for randomization stratification factor VH level (VH >=4 versus VH <4).|
1641501|NCT01900431|3016703|Superiority||LS Mean Difference|-6.4|Standard Error of the Mean|3.55||0.0825|2-Sided|90.0|-12.374|-0.35||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT (Automatic measurement from SD-OCT).|
1641502|NCT01900431|3016704|Superiority||LS Mean Difference|-26.5|Standard Error of the Mean|14.2||0.0683|2-Sided|90.0|-50.41|-2.68||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT (Automatic measurement from SD-OCT).|
1641503|NCT01900431|3016705|Superiority||LS Mean Difference|5.8|Standard Error of the Mean|2.26||0.0153|2-Sided|90.0|1.99|9.67||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA.|
1641504|NCT01900431|3016706|Superiority||Odds Ratio (OR)|0.95||||1|2-Sided|90.0|0.11|6.093||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using common odds ratio which came from CMH analysis adjusted for randomization stratification factor VH level (VH >=4 versus VH <4).|
1641505|NCT01900431|3016707|Superiority||Least Square (LS) Mean Difference|-0.7|Standard Error of the Mean|0.29||0.0127|2-Sided|90.0|-1.223|-0.262||Threshold for significance at 0.05 level.|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using mixed effect model with repeated measures (MMRM) with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline adjudicated VH.|
1641616|NCT01895361|3017135|Other||Hazard Ratio (HR)|0.752|||=|0|2-Sided|95.0|0.515|1.097|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates||
1641684|NCT01892306|3017442|Other|||||||0.95|||||||Regression, Linear|||Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.|
1641506|NCT01900431|3016708|Superiority||Odds Ratio (OR)|2.1||||0.2354|2-Sided|90.0|0.8|5.6||Threshold for significance at 0.05 level.|Cochran-Mantel-Haenszel||Sarilumab 200 mg q2w vs Placebo|Analysis was performed using combined estimate for odds ratio obtained by combining the log-transformation of odds ratio from Cochran Mantel-Haenszel (CMH) analyses of the different imputed datasets, using Rubin's formulae, and then by back-transforming the combined estimate. The CMH analyses were adjusted for randomization stratification factor VH level (VH >= 4 versus VH <4).|
1641507|NCT01900392|3016710|Other||||||>|0.1|||||||Regression, Linear||||
1641508|NCT01900314|3016711|Superiority or Other|||||||0.04|||||||ANCOVA|||Repeated measures ANCOVA with baseline MADRS as co-variate|
1641509|NCT01900314|3016712|Superiority or Other|||||||0.16|||||||ANCOVA|||Repeated measures ANCOVA at 4 weeks with baseline MADRS as co-variate|
1641510|NCT01899768|3016733|Superiority or Other||Ratio of adjusted geometric means = GSK2|1.04|||||2-Sided|90.0|0.79|1.36|||||||
1641511|NCT01899768|3016733|Superiority or Other||Ratio of adjusted geometric mean|0.97|||||2-Sided|90.0|0.67|1.4|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 0-4 hr.||
1641512|NCT01899768|3016734|Superiority or Other||Ratio of adjusted geometric mean|1.36|||||2-Sided|90.0|1.07|1.72|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 4-8 hr.||
1641513|NCT01899768|3016734|Superiority or Other||Ratio of adjusted geometric mean|1.23|||||2-Sided|90.0|0.86|1.75|||||Ratio of adjusted geometric means = GSK2339345/Placebo. Estimated value and CI are presented for the mean cough count over 0-4 hr.||
1641514|NCT01899768|3016757|Superiority or Other||Ratio of adjusted geometric mean|1.02|||||2-Sided|90.0|0.87|1.19|||||Ratio of adjusted geometric means = GSK2339345/Placebo.||
1641515|NCT01899768|3016758|Superiority or Other||Ratio of adjusted geometric mean|1.26|||||2-Sided|90.0|1.1|1.44|||||Ratio of adjusted geometric means = GSK2339345/Placebo.||
1641516|NCT01899742|3016759|Superiority or Other||Mean Difference (Final Values)|0.073||||0.004|2-Sided|95.0|0.024|0.122|||Mixed Models Analysis||||
1641517|NCT01899742|3016760|Superiority or Other||Mean Difference (Final Values)|0.088|||<|0.001|2-Sided|95.0|0.045|0.131|||Mixed Models Analysis||||
1641518|NCT01899677|3016770|Superiority or Other|||||||0.76|||||||Mann whitney U||||
1641519|NCT01899677|3016771|Superiority or Other|||||||0.66|||||||Mann whitney U||||
1641520|NCT01899677|3016772|Superiority or Other|||||||0.73|||||||Mann whitney U||||
1641521|NCT01899677|3016773|Superiority or Other|||||||0.32|||||||Mann whitney U|||Mann Whitney U test was used to compare cytokine levels between groups.|
1641522|NCT01899144|3016780|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.1||0.0488|2-Sided|95.0|-0.38|0.0||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis|
1641523|NCT01899144|3016780|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.1||0.6342|2-Sided|95.0|-0.23|0.14||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis|
1641524|NCT01899144|3016780|Superiority or Other||Mean Difference (Final Values)|0.26|Standard Error of the Mean|0.1||0.0062|2-Sided|95.0|0.08|0.45|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~Albuterol MDPI 180 mcg to placebo~Albuterol MDPI 90 mcg to placebo~ProAir HFA 180 mcg to placebo~ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."|
1641525|NCT01899144|3016780|Superiority or Other||Mean Difference (Final Values)|0.45|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|0.26|0.64|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~Albuterol MDPI 180 mcg to placebo~Albuterol MDPI 90 mcg to placebo~ProAir HFA 180 mcg to placebo~ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."|
1641526|NCT01899144|3016780|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|0.21|0.59|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~Albuterol MDPI 180 mcg to placebo~Albuterol MDPI 90 mcg to placebo~ProAir HFA 180 mcg to placebo~ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."|
1641527|NCT01899144|3016780|Superiority or Other||Mean Difference (Final Values)|0.45|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|0.26|0.64|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~Albuterol MDPI 180 mcg to placebo~Albuterol MDPI 90 mcg to placebo~ProAir HFA 180 mcg to placebo~ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."|
1641528|NCT01899144|3016781|Superiority or Other||Mean Difference (Final Values)|-11.2|Standard Error of the Mean|4.87||0.0226|2-Sided|95.0|-20.8|-1.59||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis|
1641529|NCT01899144|3016781|Superiority or Other||Mean Difference (Final Values)|-1.4|Standard Error of the Mean|4.88||0.7772|2-Sided|95.0|-11.0|8.23||0.05 level of significance|ANOVA||90 mcg - 180 mcg|Pre-specified, exploratory analysis|
1641685|NCT01892306|3017443|Other|||||||0.03|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores|
1641530|NCT01899144|3016781|Superiority or Other||Mean Difference (Final Values)|12.5|Standard Error of the Mean|4.85||0.0107|2-Sided|95.0|2.93|22.05|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~Albuterol MDPI 180 mcg to placebo~Albuterol MDPI 90 mcg to placebo~ProAir HFA 180 mcg to placebo~ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."|
1641531|NCT01899144|3016781|Superiority or Other||Mean Difference (Final Values)|23.7|Standard Error of the Mean|4.85|<|0.0001|2-Sided|95.0|14.13|33.23|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~Albuterol MDPI 180 mcg to placebo~Albuterol MDPI 90 mcg to placebo~ProAir HFA 180 mcg to placebo~ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."|
1641532|NCT01899144|3016781|Superiority or Other||Mean Difference (Final Values)|21.2|Standard Error of the Mean|4.87|<|0.0001|2-Sided|95.0|11.6|30.81|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~Albuterol MDPI 180 mcg to placebo~Albuterol MDPI 90 mcg to placebo~ProAir HFA 180 mcg to placebo~ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."|
1641533|NCT01899144|3016781|Superiority or Other||Mean Difference (Final Values)|22.6|Standard Error of the Mean|4.87|<|0.0001|2-Sided|95.0|13.0|32.2|||ANOVA|Mixed effect analysis of variance with fixed effects of sequence, treatment group, and period, and random effect for the patient within sequence|Active - Placebo|"The mean difference between each active group and placebo was tested in a sequential manner:~Albuterol MDPI 180 mcg to placebo~Albuterol MDPI 90 mcg to placebo~ProAir HFA 180 mcg to placebo~ProAir HFA 90 mcg to placebo Each test was 2 sided and done at the 0.05 level of significance. However, if a test was not significant at this level, no further tests were done. This sequential process assured that the overall alpha level for the entire series was not greater than 0.05."|
1641534|NCT01898598|3016853|Superiority or Other||Percentage Difference|-40.0|||||2-Sided|95.0|-85.3|14.2|||||||
1641535|NCT01898598|3016854|Superiority or Other||Difference in Clinical Response Rates|-21.8|||||2-Sided|95.0|-71.6|32.1||||||The 95 % confidence interval (CI) for the difference in response rates was computed using the exact unconditional confidence limits method.|
1641536|NCT01898442|3016863|Superiority or Other|||||||0.017|||||||ANCOVA||||
1641537|NCT01898299|3016866|Superiority||Cohen's d effectsize|0.48||||0.036|2-Sided||||||ANCOVA|Control for Chlopromazine equivalents|||
1641538|NCT01898208|3016871|Superiority or Other|||||||0.654|||||||Kruskal-Wallis|||Comparison between the 3 arms for antimicrobials costs.|
1641539|NCT01898208|3016871|Superiority or Other|||||||0.0006|||||||Kruskal-Wallis|||Comparison between the 3 arms for laboratory test cost.|
1641540|NCT01898208|3016871|Superiority or Other|||||||0.7789|||||||Kruskal-Wallis|||Comparison between the 3 arms for total hospitalization costs.|
1641541|NCT01898208|3016873|Superiority or Other|||||||0.82|||||||Fisher Exact|||This analysis is a comparison across all three groups.|
1641542|NCT01898208|3016874|Superiority or Other|||||||0.42|||||||Fisher Exact|||Comparison of the 3 groups for attributable mortality.|
1641543|NCT01898208|3016874|Superiority or Other|||||||0.74|||||||Fisher Exact|||Comparison of the 3 groups for all-cause mortality.|
1641544|NCT01898208|3016875|Superiority or Other|||||||0.6|||||||Kruskal-Wallis|||This analysis compares the three groups.|
1641545|NCT01898208|3016876|Superiority or Other|||||||0.62|||||||Chi-squared|||This analysis is a comparison of the 3 groups.|
1641546|NCT01898208|3016877|Superiority or Other|||||||0.9|||||||Kruskal-Wallis||||
1641547|NCT01898208|3016878|Superiority or Other|||||||0.79|||||||Kruskal-Wallis|||This analysis is to compare the three groups.|
1641548|NCT01898208|3016879|Superiority or Other||||||<|0.0001|||||||Kruskal-Wallis|||This analysis compares FilmArray plus antimicrobial stewardship to the control arm.|
1641549|NCT01898208|3016879|Superiority or Other||||||<|0.0001|||||||Kruskal-Wallis|||This analysis compares the FilmArray test to control arm.|
1641550|NCT01898208|3016880|Superiority or Other|||||||0.015|||||||Chi-squared|||This analysis compares the 3 groups.|
1641551|NCT01898208|3016881|Superiority or Other|||||||0.04|||||||Kruskal-Wallis|||For time to first appropriate escalation comparing the 3 groups.|
1641552|NCT01898208|3016881|Superiority or Other||||||<|0.0001|||||||Kruskal-Wallis|||For time to first appropriate de-escalation comparing the 3 groups.|
1641553|NCT01898208|3016882|Superiority or Other|||||||0.55|||||||Kruskal-Wallis|||This analysis compares the 3 groups.|
1641554|NCT01898208|3016883|Superiority or Other|||||||0.56|||||||Kruskal-Wallis|||For cefepime.|
1641555|NCT01898208|3016883|Superiority or Other|||||||0.012|||||||Kruskal-Wallis|||For piperacillin-tazobactam.|
1641556|NCT01898208|3016883|Superiority or Other|||||||0.035|||||||Kruskal-Wallis|||For nafcillin, oxacillin, or cefazolin.|
1641557|NCT01898208|3016883|Superiority or Other|||||||0.2|||||||Kruskal-Wallis|||For vancomycin, methicillin-susceptible Staphylococcus aureus.|
1641558|NCT01898208|3016883|Superiority or Other|||||||0.037|||||||Kruskal-Wallis|||For vancomycin-susceptible enterococci|
1641559|NCT01898208|3016883|Superiority or Other|||||||0.032|||||||Kruskal-Wallis|||For vancomycin, organisms not requiring vancomycin.|
1641560|NCT01898208|3016883|Superiority or Other|||||||0.92|||||||Kruskal-Wallis|||For Vancomycin, all patients|
1641617|NCT01895361|3017135|Other||Hazard Ratio (HR)|0.495|||=|0|2-Sided|95.0|0.331|0.741|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates||
1641561|NCT01898091|3016896|Superiority or Other|||||||0.84|||||||Wilcoxin rank sum test|||Simulations determined power to detect significant difference defined as a mean difference of 1 unit (MTS scale). Feasibility study provided proportion of patients in control and neem group with change scores of 0, 1, 2, 3, and 4 as (5%, 10%, 10%, 45% and 30%) and (15%, 20%, 30%, 25% and 10%), respectively. Simulated 10,000 trials using multinomial distributions by the percentages above, with 20 patients per group, provided 80% power to detect 0.9 unit difference using a one-sided alpha of 0.05.|
1641562|NCT01898078|3016900|Superiority or Other||Least Square Mean Ratio|1.15|||||2-Sided|90.0|0.96|1.39|||||Estimates for each PK parameter were obtained using a mixed effects model of log(PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC∞ plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean|
1641563|NCT01898078|3016901|Superiority or Other||Least Square Mean Ratio|1.16|||||2-Sided|90.0|1.01|1.34|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed AUC(last) plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric mean.|
1641564|NCT01898078|3016902|Superiority or Other||Least Squares Mean Ratio|0.97|||||2-Sided|90.0|0.85|1.12|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the treatment effect, sequence effect, period effect and random terms for participants within sequence.|The confidence intervals are calculated for the difference in the LS means of the ln-transformed Cmax plain values (difference = Fed/Fasted). Antilogs of the confidence limits for the difference are taken to construct the confidence intervals for the ratio of the geometric means.|
1641565|NCT01898013|3016903|Superiority||Mean Difference (Final Values)|1.06|Standard Error of the Mean|0.13||0.62|2-Sided||||||Mixed Models Analysis||||
1641566|NCT01898013|3016904|Superiority||Mean Difference (Final Values)|0.93|Standard Error of the Mean|0.13||0.63|2-Sided||||||Mixed Models Analysis||||
1641567|NCT01898013|3016905|Superiority||Mean Difference (Final Values)|1.18|Standard Error of the Mean|0.16||0.23|2-Sided||||||Mixed Models Analysis||||
1641568|NCT01898013|3016906|Superiority||Mean Difference (Final Values)|0.97|Standard Error of the Mean|0.12||0.79|2-Sided||||||Mixed Models Analysis||||
1641569|NCT01898013|3016907|Superiority||Mean Difference (Final Values)|0.83|Standard Error of the Mean|0.14||0.26|2-Sided||||||Mixed Models Analysis||||
1641570|NCT01898013|3016908|Superiority||Mean Difference (Final Values)|-0.56|Standard Error of the Mean|0.25||0.02|2-Sided|||||a priori threshold set at 0.05|Mixed Models Analysis||||
1641571|NCT01897532|3016980|Other||Hazard Ratio (HR)|1.04||||0.6918|2-Sided|95.0|0.89|1.22||p−value for HR ≥1.0 (1−sided)|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow’s method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.|
1641572|NCT01897532|3016981|Other||Hazard Ratio (HR)|1.02||||0.6301|2-Sided|95.0|0.89|1.17||p−value for HR ≥1.0 (1−sided).|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow’s method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.|
1641573|NCT01897532|3016981|Non-Inferiority|The non-inferiority margin was chosen as 1.3 (FDA Guidance for Industry - Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes).|Hazard Ratio (HR)|1.02||||0.0002|2-Sided|95.0|0.89|1.17||p−value for Hazard ratio (HR) ≥1.3 (1−sided)|Regression, Cox|Based on a Cox regression model with terms for treatment group and region.||Cox proportional hazard regression model was performed to compare the effect of linagliptin versus placebo. Model included randomised treatment and geographical region as factors. Breslow’s method was used for dealing with ties. First hypothesis (non-inferiority of the primary endpoint) was to be tested at the one-sided alpha-level of 2.5%. In case of significance the next set of hypotheses (two separate hypothesis tests) were to be tested with a sequentially rejective multiple test procedure.|
1641574|NCT01897402|3016988|Non-Inferiority or Equivalence|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|0.3|||||2-Sided|95.0|-8.5|9.1|||||Serogroup W-135|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.|
1641575|NCT01897402|3016988|Non-Inferiority or Equivalence|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|-1.0|||||2-Sided|95.0|-9.9|7.9|||||Serogroup Y|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.|
1641654|NCT01894230|3017282|Equivalence|Month 8|Slope|-0.2468|Standard Error of the Mean|0.4315||0.57|2-Sided||||||Regression, Linear||||
1641576|NCT01897402|3016988|Non-Inferiority or Equivalence|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|-6.0|||||2-Sided|95.0|-14.6|2.6|||||Serogroup C|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.|
1641577|NCT01897402|3016988|Non-Inferiority or Equivalence|The assumptions for the sample size calculations were: 1) Seroconversion for the control vaccine (Menactra) is 40-80% and 2) the true treatments are theoretically equal and 3) the power of detecting non-inferiority is 90%.|Percentage Difference|0.6|||||2-Sided|95.0|-7.9|9.1|||||Serogroup A|The hypothesis was that the test vaccine is comparable to the licensed active control vaccine. Differences between treatment groups were described using exact two-sided 95% confidence intervals on differences in % seroconversion between the two treatment groups (test vaccine minus reference vaccine) for each serogroup. If the lower bound of the difference is ≥ -15%, then the test vaccine meets the preliminary criterion for non-inferiority.|
1641578|NCT01896895|3017030|Superiority||LS mean difference|-0.5|||=|0|2-Sided|95.0|-1.1|0.2|||ANCOVA|||The difference in change of JRS severity subscore between treatment groups was analyzed by an ANCOVA according to a hierarchical test procedure. Second step of hierarchy is hypothesis of superiority of 25 unit dose group NT 201 compared to placebo. This was tested confirmatory (α=0.05, 2-sided) by an ANCOVA with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates based on LS means comparison. Missing values were imputed by LOCF.|
1641579|NCT01896895|3017030|Superiority||LS mean difference|-1.2|||=|0|2-Sided|95.0|-1.9|-0.6|||ANCOVA|||The difference in change of JRS severity subscore between treatment groups was analyzed by an ANCOVA according to a hierarchical test procedure. First step of hierarchy is hypothesis of superiority of 50 unit dose group NT 201 compared to placebo. This was tested confirmatory (α=0.05, 2-sided) by an ANCOVA with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates based on LS means comparison. Missing values were imputed by LOCF.|
1641580|NCT01896687|3017051|Superiority or Other||||||<|0.001||||||"The worst pain and interference scores as dependent variables, and time (baseline, 1-, and 3 week follow up visit), group (Calmare or Sham), and group by time interaction terms as the independent variable."|ANOVA||||
1641581|NCT01896232|3017064|Superiority or Other||Treatment Rate Ratio|1.2|Standard Error of the Mean|0.22|||2-Sided|95.0|0.86|1.72|||||The treatment rate ratio is Etelcalcetide : Cinacalcet.|This analysis was conducted using a generalized linear mixed model with Poisson regression including screening value of the number of episodes of vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.|
1641582|NCT01896232|3017065|Superiority or Other||Treatment Difference|-0.03|Standard Error of the Mean|0.08|||2-Sided|95.0|-0.18|0.12|||||Treatment difference is Etelcalcetide - Cinacalcet.|Analyzed using an analysis of covariance (ANCOVA) model adjusted for screening PTH level and region.|
1641583|NCT01896232|3017066|Superiority or Other||Odds Ratio (OR)|1.15|||||2-Sided|95.0|0.83|1.59|||||The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.|Analyzed using the Cochran-Mantel-Haenszel method stratified by screening PTH level and region.|
1641584|NCT01896232|3017067|Superiority or Other||Treatment difference|-3.48|Standard Error of the Mean|0.65|||2-Sided|95.0|-4.76|-2.21|||||Treatment difference is Etelcalcetide - Cinacalcet.|Analyzed using a repeated measures mixed effects model, including treatment group, randomization stratification factors (screening PTH level and region), study week, and study week by treatment as fixed effects.|
1641585|NCT01896232|3017068|Superiority or Other||Treatment Rate Ratio|1.2|Standard Error of the Mean|0.15||0.27|2-Sided|95.0|0.89|1.49|||Generalized Linear Mixed Model||The treatment rate ratio is Etelcalcetide : Cinacalcet.|"Analyzed using a generalized linear mixed model with Poisson regression, including screening value of the number of days of nausea and vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."|
1641586|NCT01896232|3017069|Superiority or Other||Odds Ratio (OR)|1.59||||0.004|2-Sided|95.0|1.16|2.17|||Cochran-Mantel-Haenszel||The CMH stratified odds ratio is Etelcalcetide : Cinacalcet.|"Achievement of > 30% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel test stratified by screening PTH level and region.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."|
1641587|NCT01896232|3017070|Superiority or Other||Odds Ratio (OR)|1.65||||0.001|2-Sided|95.0|1.21|2.23|||Cochran-Mantel-Haenszel||The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.|"Achievement of > 50% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by screening PTH level and region.~Superiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided)."|
1641588|NCT01896232|3017071|Non-Inferiority or Equivalence|Etelcalcetide was considered non-inferior to cinacalcet if the upper bound of the 2-sided 95% confidence interval (CI) of the treatment difference (cinacalcet - etelcalcetide) was < 12%, the prespecified margin for non-inferiority.|Stratified Treatment Difference|-10.48|||||2-Sided|95.0|-17.45|-3.51||||||"The analysis was conducted on the Full Analysis Set (683 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.~The Mantel-Haenszel estimator was used to calculate the treatment difference between the proportions (Cinacalcet - Etelcalcetide) stratified by screening PTH level and region."|
1641589|NCT01896050|3017091|Superiority or Other||Odds Ratio (OR)|0.98|||||2-Sided|95.0|0.92|1.04||||||Association between baseline body mass index and discontinuation of aromatase inhibitor therapy. The original statistical analysis plan only called for analyzing the aromatase inhibitor-treated patients, not the tamoxifen-treated patients.|
1641590|NCT01896050|3017092|Superiority or Other|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in maximum grip strength between baseline and 12 months for aromatase inhibitor-treated versus tamoxifen-treated patients|
1641997|NCT01884545|3018054|Superiority|||||||0.9999|||||||Regression, Linear||||
1641591|NCT01896050|3017093|Superiority or Other||BMI squared|-0.01845|Standard Error of the Mean|0.02308||0.4262|2-Sided||||||Regression, Linear|||Examine association between change in body mass index and change in grip strength with aromatase inhibitor therapy. For the primary outcome, linear regression was used for analysis with change of grip strength as response variable. In the original statistical analysis plan only aromatase inhibitor-treated patients were to be included in this analysis. This analysis was not performed on the tamoxifen group because it isn't clinically relevant.|
1641592|NCT01896050|3017093|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Compare difference in change in body mass index between baseline and 12 months between aromatase inhibitor- and tamoxifen-treated patients|
1641593|NCT01895972|3017095|Other||||||<|0.001||||||The reduction from baseline in IOP was significant at all post-baseline assessment time points through Week 52.|t-test, 2 sided|||comparison vs. baseline|
1641594|NCT01895946|3017101|Superiority or Other||Least square means difference (LSM)|0.89|||||2-Sided|90.0|0.76|1.05|||||||
1641595|NCT01895946|3017101|Superiority or Other||Least square means difference (LSM)|0.9|||||2-Sided|90.0|0.77|1.06|||||||
1641596|NCT01895946|3017102|Superiority or Other||Least square means difference (LSM)|0.67|||||2-Sided|90.0|0.55|0.82|||||||
1641597|NCT01895946|3017102|Superiority or Other||Least square mean difference (LSM)|1.02|||||2-Sided|90.0|0.86|1.2|||||||
1641598|NCT01895608|3017111|Other|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.181|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in balance confidence following cognitive training that incorporates speed of processing tasks compared to general cognitive training.|
1641599|NCT01895608|3017111|Other|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.263|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in balance confidence following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.|
1641600|NCT01895608|3017112|Other|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.852|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in gait speed following cognitive training that incorporates speed of processing tasks compared to general cognitive training.|
1641601|NCT01895608|3017112|Other|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.313|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in gait speed following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.|
1641602|NCT01895608|3017113|Other|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.171|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following cognitive training that incorporates speed of processing tasks compared to general cognitive training.|
1641603|NCT01895608|3017113|Other|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in static balance as measured by sensory organization test following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.|
1641604|NCT01895608|3017114|Other|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.662|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following cognitive training that incorporates speed of processing tasks compared to general cognitive training.|
1641605|NCT01895608|3017114|Other|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in fall risk as measured by dynamic gait index following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.|
1641606|NCT01895608|3017115|Other|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||1|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.|
1641607|NCT01895608|3017115|Other|non-parametric statistical analysis: Mann Whitney U Test for independent samples||||||0.181|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.|
1641608|NCT01895608|3017116|Other|||||||0.414|||||||Wilcoxon (Mann-Whitney)|non-parametric statistical analysis: Mann Whitney U Test for independent samples||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following cognitive training that incorporates speed of processing tasks compared to general cognitive training.|
1641609|NCT01895608|3017116|Other|non-parametric statistic: Mann-Whitney U test for independent samples||||||0.562|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: There will not be a difference in improvement in walking under dual-task conditions following balance rehabilitation that incorporates dual-task practice compared to standard balance rehabilitation.|
1641610|NCT01895361|3017132|Other||Hodges-Lehmann median absolute diff.|0.0|||=|0|2-Sided|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.|||
1641611|NCT01895361|3017132|Other||Hodges-Lehmann median absolute diff.|0.0|||=|0|2-Sided|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata|||
1641612|NCT01895361|3017133|Other||Hodges-Lehmann median absolute diff.|-0.87|||=|0|2-Sided|95.0|-1.77|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata|||
1641613|NCT01895361|3017133|Other||Hodges-Lehmann median absolute diff.|-1.0|||=|0|2-Sided|95.0|-1.98|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata|||
1641614|NCT01895361|3017134|Other||Hazard Ratio (HR)|0.693|||=|0|2-Sided|95.0|0.44|1.092|||Log Rank||Calculated based on Cox regression analysis with HU therapy (yes, no), categorized crises history (2 to 4, 5 to 10), and treatment as covariates||
1641618|NCT01895361|3017136|Other||Hodges-Lehmann median absolute diff.|0.0|||=|0|2-Sided|95.0|-3.9|2.61|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.|||
1641619|NCT01895361|3017136|Other||Hodges-Lehmann median absolute diff.|0.0|||=|0|2-Sided|95.0|-4.36|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.|||
1641620|NCT01895361|3017137|Other||Change vs placebo (%)|-32.6|||||1-Sided||||||||||
1641621|NCT01895361|3017137|Other||Change vs placebo (%)|-45.3|||||1-Sided||||||||||
1641622|NCT01895361|3017138|Other||Hodges-Lehmann median absolute diff.|-0.69|||=|0|2-Sided|95.0|-1.84|0.02|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crises history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.|||
1641623|NCT01895361|3017138|Other||Hodges-Lehmann median absolute diff.|-1.01|||=|0|2-Sided|95.0|-2.0|0.0|||Stratified Wilcoxon Rank Sum Test|with HU therapy (yes, no) and categorized crisis history (2 to 4, 5 to 10) as recorded in the IXRS system as the strata.|||
1641624|NCT01895270|3017160|Superiority||Slope|0.34|Standard Error of the Mean|0.42||0.42|2-Sided||||||Mixed Models Analysis||||
1641625|NCT01895062|3017169|Superiority or Other||||||<|0.022|||||||t-test, 2 sided||||
1641626|NCT01894841|3017204|Superiority||Partial eta squared|0.01||||0.62|2-Sided||||||RMANOVA|Adjusted for change in depression from baseline to 1yr (measured via QIDS).|||
1641627|NCT01894841|3017205|Superiority||Partial eta-squared|0.003||||0.96|2-Sided|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA||||
1641628|NCT01894841|3017206|Superiority||Partial eta squared|0.02||||0.49|2-Sided|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA||||
1641629|NCT01894841|3017207|Superiority||Partial eta squared|0.01||||0.79|2-Sided||||||RMANOVA|Adjusted for change in depression from baseline to 1yr (measured via QIDS).|||
1641630|NCT01894841|3017208|Superiority||Partial eta squared|0.03||||0.13|2-Sided|||||Adjusted for change in depression from baseline to 1yr (measured via QIDS).|RMANOVA||||
1641631|NCT01894568|3017238|Non-Inferiority or Equivalence|0.4% is the margin of Non-inferiority|LS Mean Difference|-0.24||||0.005|2-Sided|95.0|-0.41|-0.07|||Mixed Models Analysis||||
1641632|NCT01894256|3017260|Superiority or Other||Geometric least squares means ratio|1.44|||||2-Sided|90.0|1.1|1.89|||||GLS mean for Moderate Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.|
1641633|NCT01894256|3017260|Superiority or Other||Geometric least squares means ratio|1.24|||||2-Sided|90.0|1.06|1.47|||||GLS mean for Mild Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.|
1641634|NCT01894256|3017261|Superiority or Other||Geometric least squares means ratio|1.26|||||2-Sided|90.0|1.06|1.48|||||GLS mean for Moderate Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.|
1641635|NCT01894256|3017261|Superiority or Other||Geometric least squares means ratio|1.15|||||2-Sided|90.0|1.04|1.27|||||GLS mean for Mild Renal Impairment group vs GLS mean for Normal Renal Function|Null hypothesis: There are no clinically significant differences in the PK of olaparib when administered to patients with moderate or mild renal impairment compared to patients with normal renal function.|
1641636|NCT01894230|3017273|Equivalence|Month 8, BMQ Concerns|Slope|-1.0083|Standard Error of the Mean|0.737||0.1739|2-Sided||||||Regression, Linear||||
1641637|NCT01894230|3017273|Equivalence|Month 3, BMQ Concerns|Slope|-0.862|Standard Error of the Mean|0.686||0.2113|2-Sided||||||Regression, Linear||||
1641638|NCT01894230|3017273|Equivalence|Month 8, BMQ Necessity|Slope|0.248|Standard Error of the Mean|0.67||0.7235|2-Sided||||||Regression, Linear||||
1641639|NCT01894230|3017273|Equivalence|Month 3 BMQ Necessity|Slope|1.163|Standard Error of the Mean|0.584||0.0486|2-Sided||||||Regression, Linear||||
1641640|NCT01894230|3017274|Equivalence|Month 8|Odds Ratio (OR)|1.085||||0.8384|2-Sided|95.0|0.495|2.38|||Regression, Logistic|Ordinal Logistic|||
1641641|NCT01894230|3017275|Equivalence|Month 8|Slope|-0.771|Standard Error of the Mean|1.781||0.6658|2-Sided||||||Regression, Linear||||
1641642|NCT01894230|3017275|Equivalence|Month 3|Slope|-0.6001|Standard Error of the Mean|1.472||0.6841|2-Sided||||||Regression, Linear||||
1641643|NCT01894230|3017276|Equivalence|Month 8|Slope|0.646|Standard Error of the Mean|1.009||0.5233|2-Sided||||||Regression, Linear||||
1641644|NCT01894230|3017276|Equivalence|Month 3|Slope|-0.211|Standard Error of the Mean|0.881||0.8106|2-Sided||||||Regression, Linear||||
1641645|NCT01894230|3017277|Equivalence|Month 8|Slope|0.298|Standard Error of the Mean|0.145||0.0429|2-Sided||||||Regression, Linear||||
1641646|NCT01894230|3017277|Equivalence|Month 3|Slope|0.098|Standard Error of the Mean|0.163||0.5477|2-Sided||||||Regression, Linear||||
1641647|NCT01894230|3017278|Equivalence|Month 8|Slope|0.258|Standard Error of the Mean|0.346||0.4579|2-Sided||||||Regression, Linear||||
1641648|NCT01894230|3017278|Equivalence|Month 3|Slope|0.143|Standard Error of the Mean|0.27||0.5965|2-Sided||||||Regression, Linear||||
1641649|NCT01894230|3017279|Equivalence|Month 3 to Month 8|Odds Ratio (OR)|1.115||||0.8815|2-Sided|95.0|0.265|4.687|||Regression, Logistic||||
1641650|NCT01894230|3017279|Equivalence|Baseline to Month 3|Odds Ratio (OR)|2.025||||0.0371|2-Sided|95.0|1.043|3.929|||Regression, Logistic||||
1641651|NCT01894230|3017280|Equivalence|MPR calculated from baseline to last patient follow-up (3 months or 8 months)|Slope|-0.053|Standard Error of the Mean|0.091||0.6692|2-Sided||||||Regression, Linear||||
1641652|NCT01894230|3017281|Equivalence|Month 8|Slope|-9.9|Standard Error of the Mean|6.333||0.12|2-Sided||||||Regression, Linear||||
1641653|NCT01894230|3017281|Equivalence|Month 3|Slope|-11.32|Standard Error of the Mean|5.68||0.0482|2-Sided||||||Regression, Linear||||
1641656|NCT01894087|3017326|Superiority||Incidence Rate Ratio|0.81|||||2-Sided|95.0|0.7|0.92|||||Numerator is Therapist-Led Brief Intervention, Denominator is Enhanced Usual Care only|Multivariable Poisson regression for the outcome of total COMM score at follow-up, adjusting for baseline level of the outcome|
1641657|NCT01894087|3017327|Superiority||Incidence Rate Ratio|0.97|||||2-Sided|95.0|0.8|1.19|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of not combining opioids with other drugs). Numerator was Therapist-Led Brief Intervention and denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to avoid combining opioids with other substances, adjusting for baseline level of the outcome.|
1641658|NCT01894087|3017327|Superiority||Incidence Rate Ratio|0.76|||||2-Sided|95.0|0.65|0.9|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of reducing or avoiding opioid use). Numerator was the Therapist-Led Brief Intervention and the denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to avoid or reduce opioid use, adjusting for baseline level of the outcome.|
1641659|NCT01894087|3017327|Superiority||Incidence Rate Ratio|1.11|||||2-Sided|95.0|0.93|1.33|||||This item was reverse coded; higher scores indicate lower intention to avoid overdose risk (for the strategy of using opioids as prescribed). Numerator was the Therapist-Led Brief Intervention and the denominator was Enhanced Usual Care only.|Multivariable Poisson regression of the outcome of intention to use opioids as prescribed, adjusting for baseline level of the outcome.|
1641660|NCT01894087|3017328|Superiority||Slope|0.1|||||2-Sided|95.0|-0.2|0.4|||||Numerator is the Therapist-Led Brief Intervention and Denominator is Enhanced Usual Care only|Multivariable linear regression of the outcome of standardized sum score of overdose symptom knowledge at 6 months follow-up, adjusted for baseline level of overdose symptom knowledge.|
1641661|NCT01894087|3017329|Superiority||Incidence Rate Ratio|0.72|||||2-Sided|95.0|0.59|0.87|||||Numerator is Therapist-led Brief Intervention, Denominator is Enhanced Usual Care only.|Multivariable Poisson regression of outcome of overdose risk behavior sum score at 6 months, adjusting for baseline level of the outcome|
1641662|NCT01893983|3017357|Equivalence|Compare whether 2 groups had any difference in risk/hazard of mental health engagement at any time during follow-up.|Cox Proportional Hazard|1.13||||0.66|2-Sided|95.0|0.81|1.58||P value 0.05 is the threshold for statistical significance|Regression, Cox|Adjusted for site, mental health treatment history and mental health symptom severity at baseline, baseline amphetamine and opioid scores.|The referral alone arm is the reference group (denominator), and the motivational coaching arm is the numerator.|Compare 2 groups in regard to time to first mental health treatment using Cox proportional hazards regression.|
1641663|NCT01893905|3017358|Superiority or Other||||||<|0.0307|||||||Pocock approach||||
1641664|NCT01893411|3017386|Superiority or Other||LS-Mean difference|0.06|||=|0|2-Sided|95.0|-0.16|0.27|||Mixed Model Repeated Measure||||
1641665|NCT01893411|3017386|Superiority or Other||LS-Mean difference|0.16|||=|0|2-Sided|95.0|-0.02|0.34|||Mixed Model Repeated Measure||||
1641666|NCT01893411|3017387|Superiority or Other||LS-Mean difference|-0.04|||=|0|2-Sided|95.0|-0.26|0.18|||Mixed Model Repeated Measure||||
1641667|NCT01893411|3017387|Superiority or Other||Least Square Mean difference|-0.04|||=|0|2-Sided|95.0|-0.23|0.14|||Mixed Model Repeated Measure||||
1641668|NCT01893281|3017398|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1641669|NCT01893203|3017403|Superiority or Other|||||||0.375|||||||McNemar||||
1641670|NCT01892865|3017404|Superiority or Other|||||||0.44|||||||Chi-squared|||Null hypothesis was that there would be no difference in the adverse event rates between the two scheduling methodologies|
1641671|NCT01892865|3017405|Superiority or Other|||||||0.04|||||||t-test, 2 sided|||Null hypothesis: There would be no difference in personnel satisfaction between the groups|
1641672|NCT01892865|3017406|Superiority or Other||Risk Ratio (RR)|1.16||||0.04|2-Sided|95.0|1.01|1.34|||Poisson Regression|||Null hypothesis was that there was no difference in throughput between the two scheduling methods|
1641673|NCT01892865|3017407|Superiority or Other||Risk Ratio (RR)|1.16||||0.04|2-Sided|95.0|1.01|1.34|||Poisson regression|||Null hypothesis: There would be no difference in throughput between the two arms|
1641674|NCT01892865|3017407|Superiority or Other||Mean Difference (Net)|23.6||||0.024|2-Sided|95.0|3.15|44.0|||t-test, 2 sided|||The null hypothesis was that there would be no difference in predictive imprecision for the end of the operative day between the two arms|
1641675|NCT01892722|3017414|Superiority||||||<|0.001|||||||Negative binomial regression model||||
1641676|NCT01892345|3017438|Other|Treatment Effect|Hazard Ratio (HR)|0.058|||<|0.0001|2-Sided|95.0|0.017|0.197|||Stratified Log-Rank Test||HR based on a stratified Cox proportional hazards model. Confidence interval = Wald confidence interval. HR for eculizumab compared with placebo represented a 94.2% reduction in the risk of relapse, 95% Wald confidence interval (80.3%, 98.3%).||
1641677|NCT01892306|3017439|Other|||||||0.14|||||||Regression, Linear|||Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.|
1641678|NCT01892306|3017439|Other|||||||0.007|||||||Regression, Linear|||Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.|
1641679|NCT01892306|3017440|Other|||||||0.04|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO-Neuroticism scores|
1641680|NCT01892306|3017440|Other|||||||0.17|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline NEO- Neuroticism scores.|
1641681|NCT01892306|3017441|Other|||||||0.37|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores|
1641682|NCT01892306|3017441|Other|||||||0.87|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ASI scores|
1641683|NCT01892306|3017442|Other|||||||0.03|||||||Regression, Linear|||Linear Regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline ACS scores.|
1641686|NCT01892306|3017443|Other|||||||0.62|||||||Regression, Linear|||Linear regression - Dependent variable: HAM-A symptom change; Independent variable: Baseline DERS scores.|
1641687|NCT01892306|3017444|Superiority or Other|||||||0.24|||||||Mixed Models Analysis|||Scores on the CSQ were analyzed using a mixed-effects linear regression analysis over 6 timepoints.|
1641688|NCT01892306|3017445|Superiority or Other|||||||0.02|||||||Mixed Models Analysis|||Scores on the HAM-D were analyzed using a mixed-effects linear regression analysis over 6 timepoints.|
1641689|NCT01892306|3017446|Superiority or Other|||||||0.02|||||||Mixed Models Analysis|||Scores on the HAM-A were analyzed using a mixed-effects linear regression analysis over 6 timepoints.|
1641690|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.3395|Standard Error of the Mean|0.19513||0.091|2-Sided|95.0|-0.7361|0.057|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641691|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.048|Standard Error of the Mean|0.20543||0.817|2-Sided|95.0|-0.4655|0.3695|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641692|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2821|Standard Error of the Mean|0.19038||0.148|2-Sided|95.0|-0.669|0.1048|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Paracingulte gyrus/BA3: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641693|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2534|Standard Error of the Mean|0.17208||0.15|2-Sided|95.0|-0.6032|0.0963|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641694|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.0232|Standard Error of the Mean|0.18117||0.899|2-Sided|95.0|-0.3914|0.3449|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641695|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2254|Standard Error of the Mean|0.1679||0.188|2-Sided|95.0|-0.5666|0.1158|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Paracingulte gyrus/BA32. Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641696|NCT01892189|3017468|Superiority or Other||LS Mean Difference|0.42|Standard Error of the Mean|0.44846||0.356|2-Sided|95.0|-0.4914|1.3314|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641697|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.4685|Standard Error of the Mean|0.47214||0.328|2-Sided|95.0|-1.428|0.491|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641698|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.4404|Standard Error of the Mean|0.43756||0.321|2-Sided|95.0|-1.3296|0.4488|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641699|NCT01892189|3017468|Superiority or Other||LS Mean Difference|0.7902|Standard Error of the Mean|0.46847||0.101|2-Sided|95.0|-0.1618|1.7423|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641700|NCT01892189|3017468|Superiority or Other||LS Mean Difference|0.0395|Standard Error of the Mean|0.49321||0.937|2-Sided|95.0|-0.9628|1.0419|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641701|NCT01892189|3017468|Superiority or Other||LS Mean Difference|0.3659|Standard Error of the Mean|0.45708||0.429|2-Sided|95.0|-0.563|1.2948|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Subgenual Cingulate/BA25: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641702|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.1615|Standard Error of the Mean|0.13647||0.245|2-Sided|95.0|-0.4388|0.1159|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641703|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.0176|Standard Error of the Mean|0.14368||0.903|2-Sided|95.0|-0.3096|0.2744|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641998|NCT01884545|3018054|Superiority|||||||0.7639|||||||Regression, Linear||||
1641704|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.1446|Standard Error of the Mean|0.13315||0.285|2-Sided|95.0|-0.4152|0.126|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641705|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.1935|Standard Error of the Mean|0.13599||0.164|2-Sided|95.0|-0.4699|0.0828|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641706|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.0065|Standard Error of the Mean|0.14317||0.964|2-Sided|95.0|-0.2975|0.2844|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641707|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.13268||0.141|2-Sided|95.0|-0.4696|0.0696|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Hippocampus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641708|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2033|Standard Error of the Mean|0.16572||0.228|2-Sided|95.0|-0.5401|0.1334|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641709|NCT01892189|3017468|Superiority or Other||LS Mean Difference|0.1279|Standard Error of the Mean|0.17447||0.468|2-Sided|95.0|-0.2266|0.4825|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641710|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2516|Standard Error of the Mean|0.16169||0.129|2-Sided|95.0|-0.5802|0.077|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641711|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.1648|Standard Error of the Mean|0.14727||0.271|2-Sided|95.0|-0.4641|0.1345|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641712|NCT01892189|3017468|Superiority or Other||LS Mean Difference|0.0932|Standard Error of the Mean|0.15504||0.552|2-Sided|95.0|-0.2219|0.4083|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641713|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2032|Standard Error of the Mean|0.14369||0.166|2-Sided|95.0|-0.4952|0.0888|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Dorsolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641714|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.4163|Standard Error of the Mean|0.18445||0.031|2-Sided|95.0|-0.7912|-0.0415|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641715|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.0652|Standard Error of the Mean|0.19419||0.739|2-Sided|95.0|-0.4599|0.3294|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641716|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.3409|Standard Error of the Mean|0.17997||0.067|2-Sided|95.0|-0.7066|0.0249|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641717|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.3042|Standard Error of the Mean|0.20531||0.148|2-Sided|95.0|-0.7214|0.1131|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641718|NCT01892189|3017468|Superiority or Other||LS Mean Difference|0.0253|Standard Error of the Mean|0.21616||0.908|2-Sided|95.0|-0.414|0.4646|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641719|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2051|Standard Error of the Mean|0.20032||0.313|2-Sided|95.0|-0.6122|0.202|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Ventrolateral Prefrontal Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641720|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.183|Standard Error of the Mean|0.1387||0.196|2-Sided|95.0|-0.4649|0.0989|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641721|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.0527|Standard Error of the Mean|0.14603||0.72|2-Sided|95.0|-0.3495|0.244|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641722|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.22|Standard Error of the Mean|0.13533||0.113|2-Sided|95.0|-0.495|0.055|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641723|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2446|Standard Error of the Mean|0.1447||0.1|2-Sided|95.0|-0.5387|0.0494|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641724|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.0854|Standard Error of the Mean|0.15234||0.579|2-Sided|95.0|-0.395|0.2242|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641725|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2641|Standard Error of the Mean|0.14118||0.07|2-Sided|95.0|-0.551|0.0228|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Thalamus: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641726|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.214|Standard Error of the Mean|0.15219||0.169|2-Sided|95.0|-0.5233|0.0953|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641727|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.1007|Standard Error of the Mean|0.16023||0.534|2-Sided|95.0|-0.4263|0.2249|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641728|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.1037|Standard Error of the Mean|0.14849||0.49|2-Sided|95.0|-0.4055|0.1981|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641729|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.4377|Standard Error of the Mean|0.16468||0.012|2-Sided|95.0|-0.7724|-0.1031|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641730|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.0539|Standard Error of the Mean|0.17338||0.758|2-Sided|95.0|-0.4062|0.2985|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641731|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.1774|Standard Error of the Mean|0.16068||0.277||95.0|-0.504|0.1491|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Substantia Nigra: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641732|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.0602|Standard Error of the Mean|0.18209||0.743|2-Sided|95.0|-0.4303|0.3098|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641733|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2037|Standard Error of the Mean|0.1917||0.295|2-Sided|95.0|-0.5933|0.1859|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641734|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.138|Standard Error of the Mean|0.17766||0.443|2-Sided|95.0|-0.4991|0.223|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641735|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2154|Standard Error of the Mean|0.18048||0.241|2-Sided|95.0|-0.5822|0.1514|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641775|NCT01890746|3017563|Superiority||Hazard Ratio (HR)|2.46||||0.0781|2-Sided|95.0|0.95|6.38|||Log Rank||||
1641736|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.0357|Standard Error of the Mean|0.19001||0.852|2-Sided|95.0|-0.4218|0.3505|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641737|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.0084|Standard Error of the Mean|0.17609||0.962|2-Sided|95.0|-0.3663|0.3495|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Amygdala: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641738|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.1727|Standard Error of the Mean|0.13695||0.216|2-Sided|95.0|-0.451|0.1056|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641739|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.0845|Standard Error of the Mean|0.14418||0.562|2-Sided|95.0|-0.3775|0.2085|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641740|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.3269|Standard Error of the Mean|0.13362||0.02|2-Sided|95.0|-0.5985|-0.0554|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641741|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.1164|Standard Error of the Mean|0.14608||0.431|2-Sided|95.0|-0.4133|0.1804|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641742|NCT01892189|3017468|Superiority or Other||LS Mean Difference|0.0134|Standard Error of the Mean|0.1538||0.931|2-Sided|95.0|-0.2991|0.326|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641743|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.3059|Standard Error of the Mean|0.14253||0.039|2-Sided|95.0|-0.5955|-0.0162|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Striatum: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641744|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2464|Standard Error of the Mean|0.19276||0.21|2-Sided|95.0|-0.6381|0.1453|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641745|NCT01892189|3017468|Superiority or Other||LS Mean Difference|0.1362|Standard Error of the Mean|0.20294||0.507|2-Sided|95.0|-0.2762|0.5486|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641746|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.1731|Standard Error of the Mean|0.18808||0.364|2-Sided|95.0|-0.5553|0.2092|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641747|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.1504|Standard Error of the Mean|0.16583||0.371|2-Sided|95.0|-0.4874|0.1866|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641748|NCT01892189|3017468|Superiority or Other||LS Mean Difference|0.1673|Standard Error of the Mean|0.17458||0.345|2-Sided|95.0|-0.1875|0.5221|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641749|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.1155|Standard Error of the Mean|0.1618||0.48|2-Sided|95.0|-0.4443|0.2133|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Posterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641750|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2421|Standard Error of the Mean|0.18403||0.197|2-Sided|95.0|-0.6161|0.1319|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641751|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.0417|Standard Error of the Mean|0.19375||0.831|2-Sided|95.0|-0.4354|0.3521|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641776|NCT01890746|3017564|Superiority||Odds Ratio (OR)|1.1151||||0.7397|2-Sided|95.0|0.5585|2.229|||Cochran-Mantel-Haenszel||||
1641752|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.2525|Standard Error of the Mean|0.17956||0.169|2-Sided|95.0|-0.6174|0.1124|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Right Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641753|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.218|Standard Error of the Mean|0.20968||0.306|2-Sided|95.0|-0.6441|0.2081|||ANOVA||Difference between least square means of TAK-063 30 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641754|NCT01892189|3017468|Superiority or Other||LS Mean Difference|-0.0367|Standard Error of the Mean|0.22075||0.869|2-Sided|95.0|-0.4853|0.4119|||ANOVA||Difference between least square means of TAK-063 10 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using an ANOVA model with sequence, period, regimen, and participant nested within sequence as factors by regions of interest.|
1641755|NCT01892189|3017468|Superiority or Other||Least Squares (LS) Mean Difference|-0.2348|Standard Error of the Mean|0.20458||0.259|2-Sided|95.0|-0.6506|0.1809|||ANOVA||Difference between least square means of TAK-063 3 mg and Placebo.|Test the equality on the means between TAK-063 and Placebo for the region Left Anterior Cingulate Cortex: Values were obtained using analysis of variance (ANOVA) model with sequence, period, regimen and participant nested within sequence as factors by regions of interest.|
1641756|NCT01892020|3017479|Superiority or Other||Mean Difference (Net)|-1.12|Standard Error of the Mean|0.27|<|0.001||95.0|-1.66|-0.58||The 2-h PPG increment was analyzed using a normal linear mixed model with period and treatment as fixed effects and subject as a random effect.|Mixed Models Analysis|||Let D be the treatment difference (BIAsp 50 BID + metformin minus BHI 50 BID + metformin) of 2-h PPG increment after a 4-week treatment. The null hypothesis was D = 0 mmol/L. The alternative hypothesis was D ≠ 0 mmol/L. Sample size was determined using a two-sided one sample t-test at a = 0.05 under the assumption of 0.8 mmol/L mean treatment different and 80% power.|
1641757|NCT01891864|3017497|Non-Inferiority or Equivalence|The mean averaged treatment effect (ATE) of percent change from baseline in PASI score up to week 12 was derived for each patient and analyzed using an ANCOVA approach. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval [−15%; 15%].|Mean Difference (Final Values)|-0.88|||||2-Sided|95.0|-3.61|1.845|||||||
1641758|NCT01891864|3017497|Non-Inferiority or Equivalence|A MMRM (Mixed Model Repeated Method) was performed on the percentage change from baseline in PASI score from baseline to Week 12. Therapeutic equivalence in terms of the % change from baseline in PASI score was to be determined if the 95% CI for the difference between GP2015 and Enbrel was contained within the interval [−15%; 15%].|Mean Difference (Final Values)|-0.64|||||2-Sided|95.0|-3.474|2.204|||||||
1641759|NCT01891864|3017498|Non-Inferiority or Equivalence|The equivalence margin for the comparison of GP2015 with Enbrel with respect to PASI 75 response at Week 12 was based on response rates reported in two pivotal placebo controlled trials (Leonardi et al 2003; Papp et al 2005). Based on the observed effect size of 45-46%, an equivalence margin of 18% was chosen so that at least 60% of the treatment effect seen for Enbrel was maintained. A response rate of 49% was assumed for the comparator treatment Enbrel.|Risk Difference (RD)|-2.3|||||2-Sided|95.0|-9.85|5.3||||||PASI 75 response rate (proportion of patients showing at least a 75% improvement in PASI) after the first 12 weeks of treatment (Treatment Period 1) was the primary endpoint to assess equivalence between GP2015 and Enbrel®. Therapeutic equivalence in terms of PASI75 could be concluded if the exact 95% confidence interval for the difference in the PASI75 rates is completely contained within the interval [−18%; 18%]. A logistic regression model was to be employed.|
1641760|NCT01891734|3017499|Superiority or Other||Cohen's d|0.3|||<|0.05|2-Sided|95.0|||||Mixed Models Analysis||||
1641761|NCT01891734|3017500|Superiority or Other||Cohen's d|0.3|||<|0.05|2-Sided|95.0|||||Mixed Models Analysis||||
1641762|NCT01890915|3017536|Superiority or Other|||||||0.015|||||||ANOVA|||Due to impaired thermoregulatory mechanisms, subjects with tetraplegia were hypothesized to have diminished increases in sweat rate in comparison to controls after heat exposure.|
1641763|NCT01890915|3017537|Superiority or Other|||||||0.006|||||||ANOVA|||We hypothesized that subjects with tetraplegia would demonstrate a change in cognitive performance after heat exposure if they had demonstrated a significant increase in core body temperature - as was hypothesized in our primary hypothesis. Cognitive performance was measured, in part, by Interference T-scores derived from the Stroop Color and Word Test.|
1641764|NCT01890915|3017538|Superiority or Other|||||||0.0001|||||||ANOVA|||"Due to impaired thermoregulatory mechanisms secondary to spinal cord injury, subjects with tetraplegia were hypothesized to have a significant rise in core temperature after exposure to warm ambient temperatures, while control subjects were hypothesized to maintain constant core temperature.~Percent change in core temperature of subjects in each group were compared to determine if they were significantly different from baseline to warm exposure."|
1641765|NCT01890785|3017539|Superiority or Other||Ratio of geometric least squares means|0.97|||||2-Sided|90.0|0.944|0.997|||||||
1641766|NCT01890785|3017539|Superiority or Other||Ratio of geometric least squares means|0.971|||||2-Sided|90.0|0.945|0.998|||||||
1641767|NCT01890785|3017540|Superiority or Other||Ratio of geometric least squares means|0.944|||||2-Sided|90.0|0.912|0.977|||||||
1641768|NCT01890785|3017540|Superiority or Other||Ratio of geometric least squares means|0.97|||||2-Sided|90.0|0.937|1.004|||||||
1641769|NCT01890785|3017541|Superiority or Other||Ratio of geometric least squares means|0.828|||||2-Sided|90.0|0.752|0.912|||||||
1641770|NCT01890785|3017541|Superiority or Other||Ratio of geometric least squares means|0.641|||||2-Sided|90.0|0.582|0.707|||||||
1641771|NCT01890785|3017542|Superiority or Other||Ratio of geometric least squares means|0.918|||||2-Sided|90.0|0.849|0.992|||||||
1641772|NCT01890785|3017542|Superiority or Other||Ratio of geometric least squares means|0.708|||||2-Sided|90.0|0.655|0.766|||||||
1641773|NCT01890746|3017558|Superiority||Hazard Ratio (HR)|1.54||||0.0688|2-Sided|95.0|0.96|2.47|||Log Rank||||
1641774|NCT01890746|3017559|Superiority||Odds Ratio (OR)|0.8749||||0.7122|2-Sided|95.0|0.4023|1.8943|||Cochran-Mantel-Haenszel||||
1641780|NCT01890746|3017569|Superiority||Hazard Ratio (HR)|0.84||||0.7461|2-Sided|95.0|0.28|2.48|||Log Rank||||
1641781|NCT01890746|3017571|Other|Bioequivalence|Ratio of geometric means (%)|202.3|||||2-Sided|90.0|131.3|311.8|||||||
1641782|NCT01890746|3017572|Other|Bioequivalence|Ratio of geometric means (%)|286.4|||||2-Sided|90.0|90.1|910.7|||||||
1641783|NCT01890746|3017573|Other|Bioequivalence|Ratio of geometric means (%)|110.5|||||2-Sided|90.0|83.9|145.7|||||||
1641784|NCT01890746|3017574|Other|Bioequivalence|Ratio of geometric means (%)|127.1|||||2-Sided|90.0|84.2|191.9|||||||
1641785|NCT01890746|3017575|Other|Bioequivalence|Ratio of geometric means (%)|106.3|||||2-Sided|90.0|87.6|129.0|||||||
1641786|NCT01890746|3017576|Other|Bioequivalence|Ratio of geometric means (%)|80.4|||||2-Sided|90.0|57.2|113.0|||||||
1641787|NCT01890746|3017577|Other|Bioequivalence|Ratio of geometric means (%)|105.2|||||2-Sided|90.0|93.6|118.3|||||||
1641788|NCT01890746|3017578|Other|Bioequivalence|Ratio of geometric means (%)|120.0|||||2-Sided|90.0|100.7|142.6|||||||
1641789|NCT01890746|3017579|Other|Bioequivalence|Ratio of geometric means (%)|101.4|||||2-Sided|90.0|92.4|111.2|||||||
1641790|NCT01890746|3017580|Other|Bioequivalence|Ratio of geometric means (%)|91.7|||||2-Sided|90.0|76.5|110.0|||||||
1641791|NCT01890746|3017581|Other|Bioequivalence|Ratio of geometric means (%)|106.5|||||2-Sided|90.0|95.0|119.4|||||||
1641792|NCT01890746|3017582|Other|Bioequivalence|Ratio of geometric means (%)|121.0|||||2-Sided|90.0|102.5|142.8|||||||
1641793|NCT01890746|3017583|Other|Bioequivalence|Ratio of geometric means (%)|101.8|||||2-Sided|90.0|92.9|111.7|||||||
1641794|NCT01890746|3017584|Other|Bioequivalence|Ratio of geometric means (%)|92.0|||||2-Sided|90.0|76.8|110.2|||||||
1641795|NCT01890746|3017585|Other|Bioequivalence|Ratio of geometric means (%)|105.2|||||2-Sided|90.0|97.1|114.0|||||||
1641796|NCT01890746|3017586|Other|Bioequivalence|Ratio of geometric means (%)|114.9|||||2-Sided|90.0|99.5|132.7|||||||
1641797|NCT01890642|3017612|Superiority or Other|||||||0.37|||||||Kruskal-Wallis||||
1641798|NCT01890642|3017613|Superiority or Other|||||||0.0001|||||||Kruskal-Wallis||||
1641799|NCT01890642|3017614|Superiority or Other|||||||0.004|||||||Kruskal-Wallis||||
1641800|NCT01890642|3017615|Superiority or Other|||||||0.8|||||||Kruskal-Wallis||||
1641801|NCT01890642|3017616|Superiority or Other|||||||0.01|||||||Kruskal-Wallis||||
1641802|NCT01890473|3017636|Superiority or Other||ratio of geometric mean|0.976|||||2-Sided|90.0|0.888|1.07||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale, using log AUC(INF) without a formal test.|
1641803|NCT01890473|3017637|Superiority or Other||ratio of geometric mean|0.941|||||2-Sided|90.0|0.843|1.05||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale, using log (AUC (0-T) without a formal test.|
1641804|NCT01890473|3017638|Superiority or Other||ratio of geometric mean|0.908|||||2-Sided|90.0|0.815|1.01||||||The PK comparability of the two devices was assessed via a linear model for each key PK parameter in log scale (using log (Cmax) without a formal test.|
1641805|NCT01890434|3017651|Non-Inferiority|A non-inferiority margin was set as 15%.|Specificity Difference|7.8||||0.0094|2-Sided|95.0|1.6|13.2|||McNemar|McNemar 2-sided test at alpha level of 5%||Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by investigator.|
1641806|NCT01890434|3017651|Non-Inferiority|A non-inferiority margin was set as 15%.|Specificity Difference|11.1||||0.001|2-Sided|95.0|4.1|17.0|||McNemar|McNemar 2-sided test at alpha level of 5%||Specificity of gadobutrol-enhanced CMRI was compared with specificity of GSPECT by majority BR.|
1641807|NCT01890434|3017653|Non-Inferiority|A non-inferiority margin was set as 15%.|Sensitivity Difference|0.0||||1|2-Sided|95.0|-8.6|7.2|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by investigator.|
1641808|NCT01890434|3017653|Non-Inferiority|A non-inferiority margin was set as 15%|Sensitivity Difference|5.7||||0.2733|2-Sided|95.0|-5.4|14.9|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of GSPECT evaluated by majority BR.|
1641809|NCT01890434|3017655|Superiority||Sensitivity Difference|21.3|||<|0.0001|2-Sided|90.0|14.2|27.2|||McNemar|McNemar 2-sided test at alpha level of 10%|||
1641810|NCT01890434|3017655|Superiority||Sensitivity Difference|21.3|||<|0.0001|2-Sided|95.0|12.9|28.4|||McNemar|McNemar 2-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI.|
1641811|NCT01890434|3017660|Superiority||Sensitivity Difference|41.0|||<|0.0001|1-Sided|95.0|31.8||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|
1641812|NCT01890434|3017660|Superiority||Sensitivity Difference|36.2|||<|0.0001|1-Sided|95.0|26.3||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|
1641813|NCT01890434|3017660|Superiority||Sensitivity Difference|21.0|||<|5e-05|1-Sided|95.0|12.1||||McNemar|McNemar one-sided test at alpha level of 2.5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|
1641814|NCT01890434|3017661|Superiority||Sensitivity Difference|32.0|||<|0.0001|1-Sided|95.0|24.5||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|
1641815|NCT01890434|3017661|Superiority||Sensitivity Difference|26.0|||<|0.0001|1-Sided|95.0|18.2||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|
1641816|NCT01890434|3017661|Superiority||Sensitivity Difference|16.7|||<|9e-05|1-Sided|95.0|9.3||||McNemar|McNemar one-sided test at alpha level of 5%||Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|
1641837|NCT01888640|3017783|Superiority||Mean Difference (Final Values)|1.2||||0.36|2-Sided|95.0|-0.7|3.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641838|NCT01888640|3017784|Superiority||Mean Difference (Final Values)|2.4||||0.17|2-Sided|95.0|-0.6|5.3|||Linear mixed models for repeated measure||||
1641817|NCT01890421|3017675|Superiority||Sensitivity Difference|27.9|||<|0.0001|2-Sided|95.0|19.9|34.4|||McNemar 2-sided test,alpha level of 10%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images – secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least >=50% by QCA.|
1641818|NCT01890421|3017675|Superiority||Sensitivity Difference|27.9|||<|0.0001|2-Sided|95.0|18.5|35.8|||McNemar 2-sided test,alpha level of 5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images – secondary analysis of sensitivity comparison based on investigator's assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI. Maximum stenosis severity at least >=50% by QCA.|
1641819|NCT01890421|3017680|Superiority||Sensitivity Difference|30.6|||<|0.0001|1-Sided|95.0|21.7||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images – additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|
1641820|NCT01890421|3017680|Superiority||Sensitivity Difference]|34.3|||<|0.0001|1-Sided|95.0|25.2||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images – additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|
1641821|NCT01890421|3017680|Superiority||Sensitivity Difference]|7.4|||<|0.0455|1-Sided|95.0|0.5||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant CAD per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images – additional secondary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|
1641822|NCT01890421|3017681|Superiority||Sensitivity Difference|24.1|||<|0.0001|1-Sided|95.0|16.6||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 3 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images – primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 3.|
1641823|NCT01890421|3017681|Superiority||Sensitivity Difference|29.1|||<|0.0001|1-Sided|95.0|21.7||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 2 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images – primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 2.|
1641824|NCT01890421|3017681|Superiority||Sensitivity Difference|-0.7|||<|0.8694|1-Sided|95.0|-8.5||||McNemar 1-sided test,alpha level of 2.5%|||Statistical analysis 1 for presence of a myocardial perfusion defect indicating significant cad per participant on gadobutrol-enhanced CMRI versus unenhanced wall motion CMRI images – primary analysis of sensitivity comparison based on the blinded readers' assessment. Sensitivity of gadobutrol-enhanced CMRI was compared with sensitivity of unenhanced CMRI evaluated by Reader 1.|
1641825|NCT01890343|3017686|Superiority or Other|||||||0.002|||||||Kruskal-Wallis|||The effect of diagnostic group on mean cortical florbetapir binding relative to cerebellar cortex was determined.|
1641826|NCT01890122|3017718|Superiority or Other||Least Square Mean Difference|-0.68|Standard Error of the Mean|0.108|<|0.0001|2-Sided|95.0|-0.889|-0.467||An ANCOVA model was used with treatment and country as fixed effects, and Baseline HbA1c as a continuous covariate.|ANCOVA||||
1641827|NCT01890122|3017718|Superiority or Other||Least Square Mean Difference|-0.49|Standard Error of the Mean|0.107|<|0.0001|2-Sided|95.0|-0.7|-0.278||An analysis of covariance (ANCOVA) model was used with treatment and country as fixed effects, and Baseline HbA1c as a continuous covariate.|ANCOVA||||
1641828|NCT01890109|3017727|Superiority||Least Square Geometric Mean Ratio|1.14||||0.551|2-Sided|95.0|0.74|1.74|||Repeated Measures Analysis of Covariance|||Repeated measures analysis of covariance was performed on the log transformed ratio to baseline of the daily hot flash severity score. Independent variables included treatment, week, and the treatment-by-week interaction; subject served as a random effect; and the log transformed baseline daily hot flash severity score was used as a covariate.|
1641829|NCT01890109|3017728|Superiority||Least Square Geometric Mean Ratio|1.1||||0.723|2-Sided|95.0|0.66|1.83|||Repeated Measures Analysis of Covariance|||Repeated measures analysis of covariance was performed on the log transformed ratio to baseline of the number of daily moderate to severe hot flashes. Independent variables included treatment, week, and the treatment-by-week interaction; subject served as a random effect; and the log transformed baseline number of daily moderate to severe hot flashes was used as a covariate.|
1641830|NCT01888640|3017780|Superiority||||||>|0.99|||||||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641831|NCT01888640|3017780|Superiority||||||>|0.99|||||||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641832|NCT01888640|3017781|Superiority||Mean Difference (Final Values)|0.6||||0.008|2-Sided|95.0|0.1|1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641833|NCT01888640|3017781|Superiority||Mean Difference (Final Values)|0.2||||0.96|2-Sided|95.0|-0.2|0.7|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641834|NCT01888640|3017782|Superiority||Mean Difference (Final Values)|42.0|||>|0.99|2-Sided|95.0|-34.0|117.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641835|NCT01888640|3017782|Superiority||Mean Difference (Final Values)|19.0|||>|0.99|2-Sided|95.0|-58.0|96.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641836|NCT01888640|3017783|Superiority||Mean Difference (Final Values)|1.0||||0.58|2-Sided|95.0|-0.8|2.8|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641915|NCT01887678|3017858|Superiority or Other||Least Squares|-6.32||||0.0376|2-Sided|95.0|-12.28|-0.37|||ANCOVA|||Day 85±3|
1641839|NCT01888640|3017784|Superiority||Mean Difference (Final Values)|1.1|||>|0.99|2-Sided|95.0|-1.9|4.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641840|NCT01888640|3017785|Superiority||Mean Difference (Final Values)|-0.6|||>|0.99|2-Sided|95.0|-2.4|1.3|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641841|NCT01888640|3017785|Superiority||Mean Difference (Final Values)|-0.4|||>|0.99|2-Sided|95.0|-2.3|1.5|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641842|NCT01888640|3017786|Superiority||Mean Difference (Final Values)|-0.9|||<|0.0001|2-Sided|95.0|-1.4|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641843|NCT01888640|3017786|Superiority||Mean Difference (Final Values)|-0.5|||<|0.036|2-Sided|95.0|-1.0|0.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641844|NCT01888640|3017787|Superiority||Mean Difference (Final Values)|-0.6||||0.048|2-Sided|95.0|-1.3|0.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641845|NCT01888640|3017787|Superiority||Mean Difference (Final Values)|-0.7||||0.043|2-Sided|95.0|-1.3|-0.01|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641846|NCT01888640|3017788|Superiority||Mean Difference (Final Values)|-1.2||||0.0006|2-Sided|95.0|-1.9|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641847|NCT01888640|3017788|Superiority||Mean Difference (Final Values)|-0.9||||0.018|2-Sided|95.0|-1.7|-0.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641848|NCT01888640|3017789|Superiority||Mean Difference (Final Values)|-7.1||||0.005|2-Sided|95.0|-12.4|-1.8|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641849|NCT01888640|3017789|Superiority||Mean Difference (Final Values)|-5.0||||0.074|2-Sided|95.0|-10.4|0.3|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641850|NCT01888640|3017790|Superiority||Mean Difference (Final Values)|-1.57||||0.0002|2-Sided|95.0|-2.6|-0.6|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641851|NCT01888640|3017790|Superiority||Mean Difference (Final Values)|-1.2||||0.016|2-Sided|95.0|-2.2|-0.1|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641852|NCT01888640|3017791|Superiority||Mean Difference (Final Values)|-2.0|||<|0.0001|2-Sided|95.0|-3.0|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641853|NCT01888640|3017791|Superiority||Mean Difference (Final Values)|-1.2|||<|0.011|2-Sided|95.0|-2.2|-0.2|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641854|NCT01888640|3017792|Superiority||Mean Difference (Final Values)|-1.9|||<|0.0001|2-Sided|95.0|-2.9|-0.9|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641855|NCT01888640|3017792|Superiority||Mean Difference (Final Values)|-1.4|||<|0.001|2-Sided|95.0|-2.4|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641856|NCT01888640|3017793|Superiority||Mean Difference (Final Values)|-1.4|||<|0.0001|2-Sided|95.0|-2.2|-0.6|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641857|NCT01888640|3017793|Superiority||Mean Difference (Final Values)|-1.2|||<|0.0006|2-Sided|95.0|-2.1|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641858|NCT01888640|3017794|Superiority||Mean Difference (Final Values)|-1.8|||<|0.0001|2-Sided|95.0|-2.8|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641859|NCT01888640|3017794|Superiority||Mean Difference (Net)|-1.3|||<|0.002|2-Sided|95.0|-2.2|-0.4|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641860|NCT01888640|3017795|Superiority||Mean Difference (Final Values)|-1.8|||<|0.0001|2-Sided|95.0|-2.6|-1.0|||Linear mixed models for repeated measure|||Visit 2 to Visit 3|
1641861|NCT01888640|3017795|Superiority||Mean Difference (Final Values)|-1.0|||<|0.008|2-Sided|95.0|-1.8|-0.2||To account for multiple tests involving pairwise treatment group comparisons, p-values were adjusted using Bonferroni’s method|Linear mixed models for repeated measure|||Visit 2-Visit 3|
1641862|NCT01888432|3017796|Other||Mean Difference (Final Values)|-10.01|Standard Error of the Mean|22.059|||2-Sided|95.0|-59.91|39.89|||||||
1641863|NCT01888432|3017797|Other||Difference in Kaplan-Meier estimate|3.2|||||2-Sided|95.0|-28.9|35.2|||||BPAR||
1641864|NCT01888432|3017797|Other||Difference in Kaplan-Meier estimate|14.9|||||2-Sided|95.0|-22.3|52.1|||||BPR||
1641865|NCT01888432|3017797|Other||Difference in Kaplan-Meier estimate|14.4|||||2-Sided|95.0|-4.2|33.1|||||tAR||
1641866|NCT01888432|3017797|Other||Difference in Kaplan-Meier estimate|3.2|||||2-Sided|95.0|-28.9|35.2|||||AR||
1641867|NCT01888432|3017797|Other||Difference in Kaplan-Meier estimate|11.1|||||2-Sided|95.0|-9.4|31.6|||||Death||
1641868|NCT01888432|3017797|Other||Difference in Kaplan-Meier estimate|14.4|||||2-Sided|95.0|-4.2|33.1|||||tBPAR||
1641869|NCT01888432|3017797|Other||Difference in Kaplan-Meier estimate|2.0|||||2-Sided|95.0|-24.6|28.7|||||Graft loss/death||
1641870|NCT01888432|3017797|Other||Difference in Kaplan-Meier estimate|6.7|||||2-Sided|95.0|-6.0|19.3|||||On-treatment composite endpoint||
1641871|NCT01888432|3017797|Other||Difference in Kaplan-Meier estimate|5.4|||||2-Sided|95.0|-19.9|30.6|||||Composite endpoint||
1641872|NCT01888432|3017801|Other||Risk Ratio (RR)|0.0|||||2-Sided|90.0|-4.2|4.2|||||Month 24||
1641873|NCT01888432|3017801|Other||Risk Ratio (RR)|-0.7|||||2-Sided|90.0|-4.5|3.1|||||Month 12||
1641874|NCT01888432|3017802|Other||Risk Difference (RD)|2.1|||||2-Sided|90.0|-3.0|7.2|||||Month 24||
1641875|NCT01888432|3017802|Other||Risk Difference (RD)|0.7|||||2-Sided|90.0|-3.9|5.3|||||Month 12||
1641876|NCT01888432|3017803|Other|Month 24 (On-treatment death)|Kaplan-Meier|0.7|||||2-Sided|90.0|-2.5|3.9|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood’s formula.||
1641877|NCT01888432|3017803|Other|Month 24|Kaplan-Meier|3.0|||||2-Sided|90.0|-1.1|7.2|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood’s formula.||
1641878|NCT01888432|3017803|Other|Month 12|Kaplan-Meier|0.7|||||2-Sided|90.0|-2.5|3.8|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood’s formula.||
1641986|NCT01884545|3018048|Superiority|||||||0.071|||||||Regression, Linear||||
1641879|NCT01888432|3017804|Other|Month 24|Kaplan-Meier|2.3|||||2-Sided|90.0|-2.1|6.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood’s formula.||
1641880|NCT01888432|3017804|Other|Month 12|Kaplan-Meier|0.7|||||2-Sided|90.0|-2.5|3.8|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood’s formula.||
1641881|NCT01888432|3017805|Other|graft loss at month 24|Kaplan-Meier|-0.8|||||2-Sided|90.0|-2.1|0.5|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood’s formula.||
1641882|NCT01888432|3017806|Other|Month 24|Kaplan-Meier|1.0|||||2-Sided|90.0|-3.6|5.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood’s formula.||
1641883|NCT01888432|3017806|Other|Month 12|Kaplan-Meier|0.9|||||2-Sided|90.0|-3.4|5.1|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood’s formula.||
1641884|NCT01888432|3017807|Other|On-treatment tBPAR - month 24|Kaplan-Meier|-2.1|||||2-Sided|90.0|-5.7|1.4|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood’s formula.||
1641885|NCT01888432|3017807|Other|tBPAR - month 24|Kaplan-Meier|-1.2|||||2-Sided|90.0|-5.1|2.6|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood’s formula.||
1641886|NCT01888432|3017807|Other|Month 12|Kaplan-Meier|-1.4|||||2-Sided|90.0|-4.7|2.0|||||KM rate and 90% CI are obtained using KM probability estimates of composite efficacy failure rates and standard error derived based on Greenwood’s formula.||
1641887|NCT01888432|3017809|Other||Mean Difference (Final Values)|3.25|Standard Error of the Mean|2.699|<|0.001|2-Sided|90.0|-1.21|7.7|||ANCOVA||||
1641888|NCT01888432|3017810|Non-Inferiority|the null hypothesis below was tested at the one-sided α = 0.05 level: H0: μT - μC ≤ -6 mL/min/1.73 m2 vs. HA: μT - μC > -6 mL/min/1.73 m^2, where μT and μC are the true means of change in eGFR (MDRD-4) from randomization to Month 12 post-transplant for the reduced tacrolimus group and control group, respectively.|Mean Difference (Net)|4.15|Standard Error of the Mean|2.574|<|0.001|2-Sided|90.0|-0.09|8.4|||ANCOVA||||
1641889|NCT01888432|3017811|Non-Inferiority|HO: πT - πC ≥ 0.12 vs. HA: πT - πC < 0.12, where πT and πC are the true proportions of composite efficacy failure of tBPAR, GL, or D, (tBPAR/GL/D) at 12 months post-transplant for the respective treatment groups. The proportion of 0.12, or 12%, was pre-determined as the non-inferiority (NI) margin for composite efficacy failure.|Kaplan-Meier|-0.7|||<|0.001|2-Sided|90.0|-5.2|3.7||Z-test p-value for non-inferiority test (non-inferiority margin = 12%) is for one-sided test and should be compared to 0.05 significance level.|Z-test|||non-inferior efficacy failure of the reduced tacrolimus regimen to control by rejecting the null hypothesis.|
1641890|NCT01887678|3017843|Superiority or Other|||||||0.0172|||||||Log Rank|For equality of survival functions||After third injection of study drug|
1641891|NCT01887678|3017843|Superiority or Other|||||||0.0346|||||||Log Rank|For equality of survival functions||After second injection of study drug|
1641892|NCT01887678|3017843|Superiority or Other|||||||0.0264|||||||Log Rank|For equality of survival functions||After first injection of study drug|
1641893|NCT01887678|3017844|Superiority or Other|||||||0.222|||||||Log Rank|Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions||After third injection of study drug|
1641894|NCT01887678|3017844|Superiority or Other|||||||0.1651||||||Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions|Log Rank|||After second injection of study drug|
1641895|NCT01887678|3017844|Superiority or Other|||||||0.2164|||||||Log Rank|Results of Kaplan-Meier Analysis with p-value from 2-sided log-rank test for equality of survival functions||After first injection of study drug|
1641896|NCT01887678|3017849|Superiority or Other||Least Squares|-0.19||||0.7443|2-Sided|95.0|-1.33|0.95|||ANCOVA|||Day 119±3|
1641897|NCT01887678|3017849|Superiority or Other||Least Squares|0.25||||0.6552|2-Sided|95.0|-0.84|1.33|||ANCOVA|||Day 85±3|
1641898|NCT01887678|3017849|Superiority or Other||Least Squares|-0.37||||0.446|2-Sided|95.0|-1.32|0.58|||ANCOVA|||Day 71±3|
1641899|NCT01887678|3017849|Superiority or Other||Least Squares|-0.4||||0.4419|2-Sided|95.0|-1.44|0.63|||ANCOVA|||Day 57±3|
1641900|NCT01887678|3017849|Superiority or Other||Least Squares|-0.49||||0.335|2-Sided|95.0|-1.48|0.51|||ANCOVA|||Day 43±3|
1641901|NCT01887678|3017849|Superiority or Other||Least Squares|-0.18||||0.7581|2-Sided|95.0|-1.35|0.99|||ANCOVA|||Day 29±3|
1641902|NCT01887678|3017849|Superiority or Other||Least Squares|-0.28||||0.6458|2-Sided|95.0|-1.49|0.92|||ANCOVA|||Day 15±1|
1641903|NCT01887678|3017849|Superiority or Other||Least Squares|-0.28||||0.6346|2-Sided|95.0|-1.45|0.89|||ANCOVA|||Day 8±1|
1641904|NCT01887678|3017850|Superiority or Other||Least Squares|-4.96||||0.1575|2-Sided|95.0|-11.86|1.93|||ANCOVA|||Day 119±3|
1641905|NCT01887678|3017850|Superiority or Other||Least Squares|-5.51||||0.1199|2-Sided|95.0|-12.47|1.45|||ANCOVA|||Day 85±3|
1641906|NCT01887678|3017850|Superiority or Other||Least Squares|-6.88||||0.0425|2-Sided|95.0|-13.52|-0.23|||ANCOVA|||Day 71±3|
1641907|NCT01887678|3017850|Superiority or Other||Least Squares|-8.88||||0.0123|2-Sided|95.0|-15.8|-1.95|||ANCOVA|||Day 57±3|
1641908|NCT01887678|3017850|Superiority or Other||Least Squares|-8.82||||0.0109|2-Sided|95.0|-15.6|-2.05|||ANCOVA|||Day 43±3|
1641909|NCT01887678|3017850|Superiority or Other||Least Squares|-6.89||||0.0472|2-Sided|95.0|-13.69|-0.09|||ANCOVA|||Day 29±3|
1641910|NCT01887678|3017850|Superiority or Other||Least Squares|-10.49||||0.0013|2-Sided|95.0|-16.85|-4.13|||ANCOVA|||Day 15±1|
1641911|NCT01887678|3017850|Superiority or Other||Least Squares|-4.97||||0.1128|2-Sided|95.0|-11.12|1.18|||ANCOVA|||Day 8±1|
1641912|NCT01887678|3017855|Superiority or Other||Least Squares|-4.77||||0.1211|2-Sided|95.0|-10.82|1.27|||ANCOVA||||
1641913|NCT01887678|3017856|Superiority or Other||Least Squares|-4.24||||0.1715|2-Sided|95.0|-10.33|1.85|||ANCOVA||||
1641914|NCT01887678|3017857|Superiority or Other||Least Squares|-4.76||||0.1373|2-Sided|95.0|-11.05|1.53|||ANCOVA||||
1641916|NCT01887678|3017858|Superiority or Other||Least Squares|-7.6||||0.0121|2-Sided|95.0|-13.52|-1.68|||Least Squares|||Day 71±3|
1641917|NCT01887678|3017858|Superiority or Other||Least Squares|-7.56||||0.0134|2-Sided|95.0|-13.54|-1.58|||ANCOVA|||Day 57±3|
1641918|NCT01887678|3017858|Superiority or Other||Least Squares|-7.25||||0.015|2-Sided|95.0|-13.08|-1.42|||ANCOVA|||Day 43±3|
1641919|NCT01887678|3017858|Superiority or Other||Least Squares|-5.24||||0.0686|2-Sided|95.0|-10.88|0.4|||ANCOVA|||Day 29±3|
1641920|NCT01887678|3017858|Superiority or Other||Least Square|-5.87||||0.0293|2-Sided|95.0|-11.15|-0.6|||ANCOVA|||Day 15±1|
1641921|NCT01887678|3017858|Superiority or Other||Least Squares|-2.15||||0.3715|2-Sided|95.0|-6.89|2.58|||ANCOVA|||Day 8±1|
1641922|NCT01887678|3017859|Superiority or Other||Least Square|-6.37|Standard Error of the Mean|3.06||0.0383|2-Sided|95.0|-12.4|-0.35|||ANCOVA||A negative value of the Least Square mean difference indicates a result in favor of Traumeel-Zeel.||
1641923|NCT01887327|3017880|Other||LS Mean Difference vs Placebo|-27.4|||=|0|2-Sided|95.0|-39.657|-15.142|||LS Mean Difference vs Placebo||||
1641924|NCT01887327|3017880|Other||LS Mean Difference vs Placebo|-31.64|||=|0|2-Sided|95.0|-44.0|-19.283|||LS Mean Difference vs Placebo||||
1641925|NCT01886937|3017898|Superiority|||||||0.26|||||||t-test, 2 sided||||
1641926|NCT01886872|3017908|Superiority||Hazard Ratio (HR)|1.0||||0.49|2-Sided|95.0|0.62|1.62||(1-sided)|Log Rank|||Arm C (Ibrutinib, Rituximab) versus Arm B (Ibrutinib)|
1641927|NCT01886872|3017908|Superiority||Hazard Ratio (HR)|0.38|||<|0.001|2-Sided|95.0|0.25|0.59||(1-sided)|Log Rank|||Arm C (Ibrutinib, Rituximab) versus Arm A (Rituximab, Bendamustine Hydrochloride)|
1641928|NCT01886872|3017908|Superiority||Hazard Ratio (HR)|0.39|||<|0.001|2-Sided|95.0|0.26|0.58||(1-sided)|Log Rank|||Arm B (Ibrutinib) versus Arm A (Rituximab, Bendamustine Hydrochloride)|
1641929|NCT01886781|3017918|Non-Inferiority or Equivalence|To determine an effect size of 0.64 with 80% power, a sample size of 27 for each group (D-IBS, C-IBS and controls), with a type 1 error of 5% using a two sided test was sufficient. Sample size based on expected behaviour of primary outcome measure. The minimally clinically important difference based on the primary outcome measure with the instrument used was 50 points.|||||<|0.05|||||||Mixed Models Analysis|||An intention-to -treat (ITT) analysis was performed on all patients who underwent randomization (n = 81). The results of the ITT analysis are presented. Changes in Severity Score was examined using the mixed model for analysis of variance to account for missing data. This model used group (treatment vs control) & time as factors.|
1641930|NCT01886716|3017919|Superiority or Other||Slope|0.07|Standard Error of the Mean|0.07|=|0|2-Sided||||||Mixed Models Analysis||F(1,517) = 1.01|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares anxiety vs. control training"|
1641931|NCT01886716|3017919|Superiority or Other||Slope|-0.03|Standard Error of the Mean|0.07|=|0|2-Sided||||||Mixed Models Analysis||F(1,517) = .18|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares alcohol vs. control training"|
1641932|NCT01886716|3017920|Superiority or Other||Slope|0.27|Standard Error of the Mean|0.95|=|0|2-Sided||||||Mixed Models Analysis||F(1,517) = .08|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares alcohol vs. control training."|
1641933|NCT01886716|3017920|Superiority or Other||Slope|-0.8|Standard Error of the Mean|0.95|=|0|2-Sided||||||Mixed Models Analysis||F(1,517) = .71|"The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points.~Note, although all 4 groups are included in this analysis, this analysis specifically compares anxiety vs. control training."|
1641934|NCT01885910|3017959|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1641935|NCT01885871|3017964|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1641936|NCT01885559|3017965|Superiority or Other (legacy)||Odds Ratio (OR)|1.0||||0.64|2-Sided|95.0|0.99|1.01|||Mixed Models Analysis|Generalized linear mixed models are used with a logit link. Model controlled for baseline age, sex, race, and clinical site.|"Odds ratio represents the multiplicative effect of ACE-I + ARB group compared to the ACE-I + placebo group in change in pain over time.~ACE-I + ARB OR per month was 1.01 (1.00, 1.01) and ACE-I + placebo OR was 1.01 (1.01, 1.01)."||
1641937|NCT01885559|3017966|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.047||||0.66|2-Sided|95.0|-0.26|0.16|||shared parameter model|Shared parameter models were used due to the informative censoring when patients who reached endpoint were not longer assessed on this measure.|||
1641938|NCT01885559|3017967|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.032||||0.75|2-Sided|95.0|-0.23|0.16|||shared parameter model|Shared parameter models were used due to informed censoring when patients who reached the primary endpoint were no longer assessed on the measure.|||
1641939|NCT01885559|3017968|Superiority or Other (legacy)||Hazard Ratio (HR)|0.82||||0.57|2-Sided|95.0|0.42|1.6|||Regression, Cox|adjusting for age, sex, race, and clinical site and accounting for recurrent events|Hazard ratio is comparing ACE-I + ARB to ACE-I + placebo||
1641940|NCT01885559|3017969|Superiority or Other (legacy)||Hazard Ratio (HR)|1.03||||0.85|2-Sided|95.0|0.8|1.32|||Regression, Cox|adjusting for age, sex, race, and clinical site and recurrent events|Hazard ratio compares ACE-I + ARB compared to ACE-I + placebo||
1641941|NCT01885559|3017970|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.7||||0.17|2-Sided|95.0|-3.9|0.7||controlling for age, sex, race, and clinical site|Mixed Models Analysis||ACE-I+ARB annual percent change minus ACE-I + placebo annual percent change||
1641987|NCT01884545|3018049|Superiority|||||||0.8029|||||||Regression, Linear||||
1641942|NCT01885559|3017971|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.2||||0.88|2-Sided|95.0|-3.2|2.8|||shared parameter model|shared parameter models used due to informative censoring that occurred when patients did not have secondary outcomes measured after reaching endpoint|||
1641943|NCT01885559|3017972|Superiority or Other (legacy)||Hazard Ratio (HR)|1.08||||0.58|2-Sided|95.0|0.82|1.42|||Regression, Cox|Analyses were adjusted for age, sex, race, baseline estimated Glomerular Filtration Rate (eGFR) and clinical site|ACE+ARB (Lisinopril-telmisartan) compared to ACE+placebo (Lisinopril-placebo)||
1641944|NCT01885208|3017978|Superiority|Superiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified superiority margin (0 %).|Treatment difference|-0.62|||<|0.0001|2-Sided|95.0|-0.8|-0.44|||Mixed Models Analysis|||The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|
1641945|NCT01885208|3017978|Non-Inferiority|Non-inferiority was concluded if the upper limit of the two-sided 95% confidence interval for the estimated treatment difference between semaglutide 1.0 mg and exenatide ER 2.0 mg was below the pre-specified non-inferiority margin (0.3 %).|Treatment difference|-0.62|||<|0.0001|2-Sided|95.0|-0.8|-0.44|||Mixed Models Analysis|||The post-baseline responses were analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|
1641946|NCT01885000|3017999|Superiority or Other||||||<|0.01|||||||Cochran-Mantel-Haenszel||||
1641947|NCT01885000|3018000|Superiority or Other|||||||0.0217|||||||Cochran-Mantel-Haenszel||||
1641948|NCT01885000|3018001|Superiority or Other|||||||0.0065|||||||Cochran-Mantel-Haenszel||||
1641949|NCT01884844|3018002|Superiority|||||||0.89|||||||Fisher Exact||||
1641950|NCT01884545|3018038|Superiority||Odds Ratio (OR)|1.591||||0.5589|2-Sided|95.0|0.335|7.544|||Regression, Logistic||||
1641951|NCT01884545|3018039|Superiority|||||||0.8452|||||||Regression, Linear||||
1641952|NCT01884545|3018039|Superiority|||||||0.4768|||||||Regression, Linear||||
1641953|NCT01884545|3018040|Superiority|||||||0.8694|||||||Regression, Linear||||
1641954|NCT01884545|3018040|Superiority|||||||0.0174|||||||Regression, Linear||||
1641955|NCT01884545|3018041|Superiority||Odds Ratio (OR)|1.347||||0.3254|2-Sided|95.0|0.744|2.439|||Regression, Logistic|||Stress behavior|
1641956|NCT01884545|3018041|Superiority||Odds Ratio (OR)|0.93||||0.8303|2-Sided|95.0|0.478|1.808|||Regression, Logistic|||Healthier eating behavior|
1641957|NCT01884545|3018041|Superiority||Odds Ratio (OR)|0.563||||0.465|2-Sided|95.0|0.121|2.629|||Regression, Logistic|||Smoking behavior|
1641958|NCT01884545|3018041|Superiority||Odds Ratio (OR)|1.83||||0.0459|2-Sided|95.0|1.011|3.311|||Regression, Logistic|||Exercise behavior|
1641959|NCT01884545|3018041|Superiority||Odds Ratio (OR)|0.928||||0.8355|2-Sided|95.0|0.461|1.872|||Regression, Logistic|||Weight reduction|
1641960|NCT01884545|3018041|Superiority||Odds Ratio (OR)|0.622||||0.121|2-Sided|95.0|0.341|1.134|||Regression, Logistic|||Stages of Change, Stress behavior|
1641961|NCT01884545|3018041|Superiority||Odds Ratio (OR)|1.216||||0.5669|2-Sided|95.0|0.622|2.376|||Regression, Logistic|||Stages of Change, Healthier eating behavior|
1641962|NCT01884545|3018041|Superiority||Odds Ratio (OR)|0.423||||0.2954|2-Sided|95.0|0.084|2.12|||Regression, Logistic|||Stages of Change, Smoking behavior|
1641963|NCT01884545|3018041|Superiority||Odds Ratio (OR)|2.252||||0.0082|2-Sided|95.0|1.234|4.111|||Regression, Logistic|||Stages of Change, Exercise behavior|
1641964|NCT01884545|3018041|Superiority||Odds Ratio (OR)|1.034||||0.9259|2-Sided|95.0|0.511|2.094|||Regression, Logistic|||Stages of Change, Weight reduction|
1641965|NCT01884545|3018042|Superiority|||||||0.7087|||||||Regression, Linear||||
1641966|NCT01884545|3018042|Superiority|||||||0.3106|||||||Regression, Linear||||
1641967|NCT01884545|3018043|Superiority|||||||0.4133|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), emotional representations|
1641968|NCT01884545|3018043|Superiority|||||||0.4302|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), treatment control|
1641969|NCT01884545|3018043|Superiority|||||||0.0872|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), personal control|
1641970|NCT01884545|3018043|Superiority|||||||0.3769|||||||Regression, Linear|||Perceived Risk for type 2 diabetes (T2D), Consequences subscale|
1641971|NCT01884545|3018043|Superiority|||||||0.0058|||||||Regression, Linear|||Perceived Risk for T2D, Emotional representations|
1641972|NCT01884545|3018043|Superiority|||||||0.3209|||||||Regression, Linear|||Perceived Risk for T2D, Treatment control|
1641973|NCT01884545|3018043|Superiority|||||||0.6378|||||||Regression, Linear|||Perceived Risk for T2D, Personal control|
1641974|NCT01884545|3018043|Superiority|||||||0.7447|||||||Regression, Linear|||Perceived Risk for T2D, Consequences subscale|
1641975|NCT01884545|3018044|Superiority|||||||0.5384|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), emotional representations|
1641976|NCT01884545|3018044|Superiority|||||||0.3483|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), treatment control subscale|
1641977|NCT01884545|3018044|Superiority|||||||0.337|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), personal control subscale|
1641978|NCT01884545|3018044|Superiority|||||||0.1085|||||||Regression, Linear|||Perceived Risk for coronary heart disease (CHD), Consequences subscale|
1641979|NCT01884545|3018044|Superiority|||||||0.2529|||||||Regression, Linear|||Perceived Risk for CHD, Emotional representations|
1641980|NCT01884545|3018044|Superiority|||||||0.2063|||||||Regression, Linear|||Perceived Risk for CHD, Treatment control|
1641981|NCT01884545|3018044|Superiority|||||||0.0636|||||||Regression, Linear|||Perceived Risk for CHD, Personal control|
1641982|NCT01884545|3018044|Superiority|||||||0.7923|||||||Regression, Linear|||Perceived Risk for CHD, Consequences subscale|
1641983|NCT01884545|3018047|Superiority|||||||0.4478|||||||Chi-squared||||
1641984|NCT01884545|3018047|Superiority|||||||0.0512|||||||Chi-squared||||
1641985|NCT01884545|3018048|Superiority|||||||0.8069|||||||Regression, Linear||||
1641999|NCT01884545|3018055|Superiority|||||||0.2275|||||||Regression, Linear||||
1642000|NCT01884545|3018055|Superiority|||||||0.1439|||||||Regression, Linear||||
1642001|NCT01884545|3018056|Superiority|||||||0.7834|||||||Regression, Linear||||
1642002|NCT01884545|3018056|Superiority|||||||0.5557|||||||Regression, Linear||||
1642003|NCT01884545|3018057|Superiority|||||||0.7751|||||||Regression, Linear||||
1642004|NCT01884545|3018057|Superiority|||||||0.8027|||||||Regression, Linear||||
1642005|NCT01884545|3018058|Superiority|||||||0.1642|||||||Regression, Linear||||
1642006|NCT01884545|3018058|Superiority|||||||0.7985|||||||Regression, Linear||||
1642007|NCT01884545|3018059|Superiority||Odds Ratio (OR)|1.333||||0.7822|2-Sided|95.0|0.173|10.254|||Regression, Logistic||||
1642008|NCT01884545|3018059|Superiority||Odds Ratio (OR)|1.333||||0.7822|2-Sided|95.0|0.173|10.254|||Regression, Logistic||||
1642009|NCT01884545|3018060|Superiority||Odds Ratio (OR)|1.045||||0.9068|2-Sided|95.0|0.5|2.183|||Regression, Logistic||||
1642010|NCT01884545|3018060|Superiority||Odds Ratio (OR)|2.853||||0.0073|2-Sided|95.0|1.326|6.139|||Regression, Logistic||||
1642011|NCT01884545|3018061|Superiority|||||||0.3754|||||||Regression, Linear||||
1642012|NCT01884545|3018061|Superiority|||||||0.6732|||||||Regression, Linear||||
1642013|NCT01884545|3018062|Superiority|||||||0.0615|||||||Regression, Linear||||
1642014|NCT01884545|3018062|Superiority|||||||0.1073|||||||Regression, Linear||||
1642015|NCT01884350|3018080|Superiority|||||||0.843||||||VKA status: Naive vs. Non-Naive|Wald Chi-square test||||
1642016|NCT01884350|3018080|Superiority|||||||0.3739||||||Permanent vs Persistant Atrial Fibrillation|Wald Chi-square test||||
1642017|NCT01884350|3018080|Superiority|||||||0.2128||||||Paroxysmal vs Persistant Atrial Fibrillation|Wald Chi-square test||||
1642018|NCT01884350|3018080|Superiority|||||||0.0679||||||>=3 Drink/Day Average vs None|Wald Chi-square test||||
1642019|NCT01884350|3018080|Superiority|||||||0.1087||||||<=2 Drink/Day Average vs None|Wald Chi-square test||||
1642020|NCT01884350|3018080|Superiority|||||||0.0264||||||Permanent vs Persistant Atrial Fibrillation|Wald Chi-square test||||
1642021|NCT01884350|3018080|Superiority|||||||0.9559||||||Paroxysmal vs Persistent Atrial Fibrillation|Wald Chi-square test||||
1642022|NCT01884350|3018080|Superiority|||||||0.191||||||Semi-routine occupations vs UKSOC1|Wald Chi-square test||||
1642023|NCT01884350|3018080|Superiority|||||||0.0117||||||Routine occupations vs UKSOC1|Wald Chi-square test||||
1642024|NCT01884350|3018080|Superiority|||||||0.673||||||Never worked and long-term unemployed vs UKSOC1|Wald Chi-square test||||
1642025|NCT01884350|3018080|Superiority|||||||0.0091||||||Lower supervisory and technical occupations vs UKSOC1|Wald Chi-square test||||
1642026|NCT01884350|3018080|Superiority|||||||0.7507||||||Lower managerial, administrative and professional occupations vs UKSOC1|Wald Chi-square test||||
1642027|NCT01884350|3018080|Superiority|||||||0.2328||||||Large employers and higher managerial and adm. occupations vs UKSOC1|Wald Chi-square test||||
1642028|NCT01884350|3018080|Superiority|||||||0.7581||||||Intermediate occupations vs UKSOC1|Wald Chi-square test||||
1642029|NCT01884350|3018080|Superiority|||||||0.7277||||||Higher professional occupations vs UKSOC1|Wald Chi-square test||||
1642030|NCT01884350|3018080|Superiority|||||||0.6982||||||Higher managerial, administrative and professional occupations vs UKSOC1|Wald Chi-square test||||
1642031|NCT01884350|3018080|Superiority|||||||0.0107||||||Mini-mental state examination score|Wald Chi-square test||||
1642032|NCT01884350|3018080|Superiority|||||||0.0305||||||>=3 Drink/Day Average vs None|Wald Chi-square test||||
1642033|NCT01884350|3018080|Superiority|||||||0.1924||||||<=2 Drink/Day Average vs None|Wald Chi-square test||||
1642034|NCT01884350|3018081|Superiority or Other||Mean Difference (Final Values)|0.82||||0.6341|2-Sided|95.0|-2.6|4.24||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided||||
1642035|NCT01884350|3018081|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.9616|2-Sided|95.0|-3.45|3.29||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided||||
1642036|NCT01884350|3018081|Superiority or Other||Mean Difference (Final Values)|0.9||||0.6399|2-Sided|95.0|-2.88|4.68||P-values are obtained from the Cochran t-test for pairwise comparison between groups (two-sided).|t-test, 2 sided||||
1642037|NCT01884350|3018081|Non-Inferiority or Equivalence|F-test p-value is obtained from the one-way ANOVA model||||||0.8707|||||||ANOVA||||
1642038|NCT01884350|3018082|Superiority or Other||||||<|0.0001||||||P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.|paired t-test|||Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks|
1642039|NCT01884350|3018082|Superiority or Other||||||<|0.0001||||||P-value is from a paired t-test comparing percent adherence at 12 and 24 Weeks. Only participants with available data at both Study Days 85 and 169 are included.|paired t-test|||Percent adherence at 12 Weeks v. Percent adherence at 24 Weeks|
1642040|NCT01884350|3018083|Superiority or Other||Difference in Percentage|-0.24||||0.8117|2-Sided|95.0|-2.18|1.7||P-value (two-sided) corresponds to the two-sample t-tests for difference in percentage of adherence at Week 24|t-test, 2 sided||||
1642041|NCT01884025|3018095|Superiority|||||||0.08||||||t value: 1.85|t-test, 2 sided||||
1642042|NCT01884025|3018096|Superiority|||||||0.26||||||t value: -1.17|t-test, 2 sided||||
1642043|NCT01884025|3018097|Superiority|||||||0.6||||||t value: .54|t-test, 2 sided||||
1642044|NCT01884025|3018098|Superiority|||||||0.85||||||t value: .19|t-test, 2 sided||||
1642045|NCT01884025|3018099|Superiority|||||||0.16||||||Chi Squared 1.98|Chi-squared||||
1642046|NCT01884025|3018100|Superiority|||||||0.08|||||||t-test, 2 sided|t Value: 1.83|||
1642047|NCT01884025|3018101|Superiority|||||||0.88|||||||t-test, 2 sided|t Value: 0.15|||
1642048|NCT01884025|3018102|Superiority or Other|||||||0.72|||||||t-test, 2 sided|t Value: -0.36|||
1642446|NCT01868594|3019394|Superiority|||||||0.6716|||||||t-test, 2 sided||||
1642049|NCT01884025|3018103|Superiority|||||||0.45|||||||t-test, 2 sided|t Value: 0.76||Change in the mental health scale of the RAND 12 were compared.|
1642050|NCT01884025|3018103|Superiority|||||||0.45|||||||t-test, 2 sided|t Value: 0.77||Change in the physical health scale of the RAND 12 were compared.|
1642051|NCT01884025|3018104|Superiority|||||||0.7|||||||t-test, 2 sided|t Value: -0.39||Change in moderate physical activity frequency between the two groups.|
1642052|NCT01884025|3018104|Superiority or Other|||||||0.72|||||||t-test, 2 sided|t Value: -0.36||Change in overall physical activity frequency were compared between the two groups.|
1642053|NCT01884025|3018105|Superiority|||||||0.75|||||||t-test, 2 sided|t Value: 0.33|||
1642054|NCT01884025|3018106|Superiority|||||||0.34|||||||t-test, 2 sided|t Value: 0.99||Change in Social Impairment Subscale|
1642055|NCT01884025|3018106|Superiority|||||||0.21|||||||t-test, 2 sided|t Value: 1.31||Change in Work/School Impairment Subscale|
1642056|NCT01884025|3018106|Superiority|||||||0.96|||||||t-test, 2 sided|"DF: 18~1 Value: -0.04"||Change in Avoidance/Rumination Subscale|
1642057|NCT01884025|3018106|Superiority|||||||0.98|||||||t-test, 2 sided|t Value: 0.03||Change in Activation Subscale|
1642058|NCT01884025|3018106|Superiority or Other|||||||0.59|||||||t-test, 2 sided|t-Value: 0.55||Change in total BADS score.|
1642059|NCT01883635|3018122|Superiority or Other|||||||0.51|||||||t-test, 2 sided|degrees of freedom=40|||
1642060|NCT01883635|3018123|Superiority or Other|||||||0.65|||||||t-test, 2 sided|degrees of freedom=40|||
1642061|NCT01883635|3018124|Superiority or Other|||||||0.14|||||||t-test, 2 sided|degrees of freedom=40|||
1642062|NCT01883440|3018139|Superiority or Other|||||||0.381|||||||Mixed Models Analysis|||In the material when all were included, there were a lot of persons with few symptoms in both Groups, which means that a larger study would be needed in order to detect significant differences.|
1642063|NCT01883440|3018140|Superiority or Other||||||<|0.037|||||||Mixed Models Analysis|Linear mixed model|||
1642064|NCT01883427|3018141|Superiority or Other||||||>|0.05||||||Not significant|Wilcoxon (Mann-Whitney)|||Too few included to reach power|
1642065|NCT01882725|3018204|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1642066|NCT01882725|3018205|Superiority or Other||||||<|0.05|||||||t-test, 1 sided||||
1642067|NCT01882647|3018208|Superiority or Other||||||<|0.01||||||The pre-specified threshold for statistical significance was ≤0.05.|Cochran-Mantel-Haenszel|||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).|
1642068|NCT01882647|3018209|Superiority or Other||||||<|0.01|||||||Cochran-Mantel-Haenszel||||
1642069|NCT01882647|3018210|Superiority or Other||||||<|0.001||||||The pre-specified threshold for statistical significance was ≤0.05.|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema and plaque elevation).|
1642070|NCT01882647|3018211|Superiority or Other||||||<|0.001||||||Treatment groups were compared with respect to the proportions of subjects with “treatment success” at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center.|Cochran-Mantel-Haenszel|Multiple imputation was used to impute missing data from the ITT population.|||
1642071|NCT01882543|3018213|Superiority or Other||Mean Difference (Final Values)|-2.8||||0.04|2-Sided|95.0|-5.5|-0.1|||ANOVA|||Analyses of the secondary variable was based on observed data without imputation.|
1642072|NCT01882543|3018214|Superiority or Other||Mean Difference (Final Values)|2.5||||0.221|2-Sided|95.0|-1.6|6.7||Physical Component|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.|
1642073|NCT01882543|3018214|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.592|2-Sided|95.0|-6.3|3.6||Mental Component|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.|
1642074|NCT01882543|3018215|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.014|2-Sided|95.0|-4.5|-0.5||ICPI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.|
1642075|NCT01882543|3018215|Superiority or Other||Mean Difference (Final Values)|-2.7||||0.005|2-Sided|95.0|-4.6|-0.9||ICSI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.|
1642076|NCT01882543|3018215|Superiority or Other||Mean Difference (Final Values)|-5.1||||0.007|2-Sided|95.0|-8.8|-1.4||ICSI/PI|ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.|
1642077|NCT01882543|3018216|Superiority or Other||Mean Difference (Final Values)|-5.4||||0.011|2-Sided|95.0|-9.5|-1.3|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.|
1642078|NCT01882543|3018217|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.028|2-Sided|95.0|-3.0|-0.2|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.|
1642079|NCT01882543|3018218|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.008|2-Sided|95.0|-2.8|-0.5|||ANCOVA|||Analyses of the secondary variable was based on observed data without imputation.|
1642080|NCT01882543|3018219|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.03|2-Sided|95.0|-2.5|-0.1|||ANCOVA|||E-diary maximum daily pain scores were calculated using an average of up to the last 7 recordings within 9 days before each visit. Missing data, including premature discontinuation, was imputed using the LOCF approach for the secondary efficacy variable of maximum daily pain score|
1642081|NCT01882543|3018220|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.061|2-Sided|95.0|-2.1|0.0|||ANCOVA|||A sample size of 28 subjects per group had 80% power to detect a 1.5-point difference in the change from baseline pain score between AQX-1125 and placebo assuming a between-subject SD of 2.0 and a 2-sided 5% significance level. Average daily pain scores were calculated using an average of up to the last 7 recordings within 9 days before each visit. Missing data, including premature discontinuation, was imputed using the LOCF approach for the primary efficacy end point of average daily pain score|
1642082|NCT01882439|3018258|Superiority or Other||Mean Difference (Net)|-0.215|Standard Error of the Mean|0.06453||0.0009|2-Sided|95.0|-0.3419|-0.0881|||Mixed Models Analysis|No imputation|||
1642083|NCT01882439|3018258|Superiority or Other||Mean Difference (Net)|-0.2529|Standard Error of the Mean|0.06422|<|0.0001|2-Sided|95.0|-0.3792|-0.1266|||Mixed Models Analysis|No imputation|||
1642084|NCT01882439|3018259|Superiority or Other||Risk Difference (RD)|23.31|Standard Error of the Mean|5.71|<|0.0001|2-Sided|95.0|12.1|34.51|||Large sample approximation|MR=NR|||
1642085|NCT01882439|3018259|Superiority or Other||Risk Difference (RD)|25.95|Standard Error of the Mean|5.73|<|0.0001|2-Sided|95.0|14.72|37.19|||Large sample approximation|Missing response (MR) = non-response (NR)|||
1642086|NCT01882088|3018277|Equivalence|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||2e-05|||||||Wilcoxon (Mann-Whitney)||||
1642087|NCT01882088|3018278|Equivalence|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.37|||||||Wilcoxon (Mann-Whitney)||||
1642088|NCT01882088|3018279|Equivalence|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.94|||||||Wilcoxon (Mann-Whitney)||||
1642089|NCT01882088|3018280|Equivalence|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.008|||||||Wilcoxon (Mann-Whitney)||||
1642090|NCT01882088|3018281|Equivalence|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.11|||||||Wilcoxon (Mann-Whitney)||||
1642091|NCT01882088|3018282|Equivalence|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.023|||||||Wilcoxon (Mann-Whitney)||||
1642092|NCT01882088|3018283|Equivalence|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.000438|||||||Wilcoxon (Mann-Whitney)||||
1642093|NCT01882088|3018284|Equivalence|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.002415|||||||Wilcoxon (Mann-Whitney)||||
1642094|NCT01882088|3018285|Equivalence|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.|
1642095|NCT01882088|3018286|Equivalence|Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.||||||2e-06|||||||Wilcoxon (Mann-Whitney)|||Data were analyzed using Statistica 10 software. Wilcoxon matched pairs test of non-parametric module was used to assess changes of the studied parameters after the course of fiber supplementation in comparison to baseline. A P value of 0.05 was considered statistically significant. Sample size calculation was performed using 1-Way ANOVA. Effect size calculation was performed for every comparison.|
1642096|NCT01881750|3018329|Superiority or Other|||||||0.42|||||||Mixed Effects Regression Model|||Group X Time Interaction Cohen's d|
1642097|NCT01881737|3018330|Superiority or Other|||||||0.0001|||||||t-test, 2 sided||||
1642098|NCT01881737|3018332|Superiority or Other|||||||0.38|||||||paired t test|Effect size Cohen's d = 0.38|||
1642099|NCT01881737|3018333|Superiority or Other|||||||0.009|||||||Paired t test|Effect Size Cohen's d = 0.53|||
1642100|NCT01881737|3018334|Superiority or Other|||||||0.848|||||||Paired t test|||Effect Size Cohen's d = -0.05|
1642101|NCT01881373|3018348|Superiority|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.18||||0.48|2-Sided|||||intervention vs control communities|Regression, Linear||||
1642102|NCT01881373|3018349|Superiority|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.05||||0.71|2-Sided||||||Regression, Linear||||
1642103|NCT01881373|3018350|Superiority|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.01||||0.9|2-Sided||||||Regression, Linear||||
1642104|NCT01881373|3018351|Superiority|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.02||||0.54|2-Sided||||||Regression, Linear|Hierarchical model.|||
1642105|NCT01881373|3018352|Superiority|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.04||||0.71|2-Sided||||||Regression, Linear|Hierarchical model.|||
1642106|NCT01881373|3018353|Superiority|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.7||||0.08|2-Sided||||||Regression, Linear|||mixed model adjusting for age and sex and cluster of community and strata of jurisdiction|
1642107|NCT01881373|3018354|Superiority|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-0.5||||0.11|2-Sided||||||Regression, Linear||||
1642108|NCT01881373|3018355|Superiority|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|3.42||||0.55|2-Sided||||||Regression, Linear||||
1642109|NCT01881373|3018356|Superiority|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-1.17||||0.68|2-Sided||||||Regression, Linear||||
1642110|NCT01881373|3018357|Superiority|Hierarchical linear model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|0.01||||0.86|2-Sided||||||Regression, Linear|Hierarchical model.|||
1642111|NCT01881373|3018358|Superiority|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Difference in prevalence|-3.6|||<|0.01|2-Sided||||||Regression, Logistic|Hierarchical model|||
1642112|NCT01881373|3018359|Superiority|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Mean Difference (Final Values)|-1.1||||0.01|2-Sided|||||Intervention vs control communities|Regression, Linear|Hierarchical model.|||
1642113|NCT01881373|3018360|Superiority|Hierarchical logistic model accounting for randomization of communities and clustering of children within communities in strata of jurisdictions weighted for number of children less than age 10 in communities. Chi-square test accounts for degrees of freedom based on number of communities.|Difference in prevalence|-4.2||||0.02|2-Sided|||||Intervention vs control communities|Regression, Logistic|Hierarchical model.|||
1642114|NCT01881230|3018364|Superiority or Other||Hazard Ratio (HR)|1.101||||0.6691|2-Sided|95.0|0.71|1.708|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; > 1 year).|
1642115|NCT01881230|3018364|Superiority or Other||Hazard Ratio (HR)|0.796||||0.2945|2-Sided|95.0|0.52|1.221|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; > 1 year).|
1642116|NCT01881230|3018364|Superiority or Other||Hazard Ratio (HR)|1.375||||0.1579|2-Sided|95.0|0.882|2.143|||Log Rank|||Hazard ratios and associated two-sided 95% confidence intervals were estimated using stratified Cox proportional hazard model. The stratification factor is the disease free interval (≤ 1 year; > 1 year).|
1642117|NCT01881230|3018367|Superiority or Other||Hazard Ratio (HR)|1.039||||0.8599|2-Sided|95.0|0.676|1.597|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (<= 1 year; > 1 year).|
1642118|NCT01881230|3018367|Superiority or Other||Hazard Ratio (HR)|0.581||||0.0152|2-Sided|95.0|0.373|0.904|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (<= 1 year; > 1 year).|
1642119|NCT01881230|3018367|Superiority or Other||Hazard Ratio (HR)|1.692||||0.0183|2-Sided|95.0|1.089|2.629|||Log Rank|||For stratified analysis, the stratified log-rank test and stratified Cox proportional hazards model were used, where the stratification factor is the disease free interval (<= 1 year; > 1 year).|
1642120|NCT01881009|3018397|Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1642121|NCT01881009|3018398|Superiority or Other (legacy)|||||||0.004|||||||Wilcoxon (Mann-Whitney)||||
1642122|NCT01880528|3018429|Superiority|||||||0.0237|||||||Kruskal-Wallis||||
1642123|NCT01880528|3018430|Superiority|||||||0.0427|||||||Kruskal-Wallis||||
1642124|NCT01880528|3018431|Superiority|||||||0.0337|||||||Kruskal-Wallis||||
1642125|NCT01880528|3018432|Superiority|||||||0.006|||||||Kruskal-Wallis||||
1642126|NCT01880515|3018434|Superiority|||||||0.41|||||||Log Rank||||
1642127|NCT01880515|3018437|Superiority or Other||Risk Ratio (RR)|0.4|||||2-Sided|95.0|0.17|0.99|||||Rash incidence of any grade was less frequent in the pre-emptive arm versus the control arm.|Rash incidence of any grade, and grade ≥2 was less frequent in the pre-emptive arm versus the control arm|
1642128|NCT01880424|3018452|Superiority or Other||Odds Ratio (OR)|2.56|||<|0.0001||95.0|1.83|3.58||Statistical significance (p<0.05) was required in both co-primary efficacy parameters to meet the primary efficacy objective; both p-values met this criterion.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for geographic region|Odds ratio for response rate (linaclotide : placebo)|Null Hypothesis: There is no difference between the linaclotide dose and placebo in the proportion of 12-week Abdominal Pain/Abdominal Discomfort Responders or there is no difference in the proportion of 12-week IBS Degree of Relief Responders. With 800 planned patients, the statistical power was expected to be approximately 95%, with an overall type I error rate controlled at the 0.05 level (2-sided), based on assumptions from NCT00948818 (LIN-MD-31) study data.|
1642129|NCT01880424|3018453|Superiority or Other||Odds Ratio (OR)|1.59||||0.001||95.0|1.21|2.09||Statistical significance (p<0.05) was required in both co-primary efficacy parameters to meet the primary efficacy objective; both p-values met this criterion.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for geographic region|Odds ratio for response rate (linaclotide : placebo)|Null Hypothesis: There is no difference between the linaclotide dose and placebo in the proportion of 12-week Abdominal Pain/Abdominal Discomfort Responders or there is no difference in the proportion of 12-week IBS Degree of Relief Responders. With 800 planned patients, the statistical power was expected to be approximately 95%, with an overall type I error rate controlled at the 0.05 level (2-sided), based on assumptions from NCT00948818 (LIN-MD-31) study data.|
1642130|NCT01880073|3018467|Other||Proportion|0.125|||||2-Sided|95.0|0.0|0.26|||||||
1642131|NCT01880073|3018468|Other||Proportion|0.875|||||2-Sided|95.0|0.74|1.0|||||||
1642132|NCT01879826|3018475|Non-Inferiority or Equivalence (legacy)|With a power of 0.8 and an acceptable type I error size of 0.05, 38 patients per group was estimated to achieve significance.||||||0.04|||||||t-test, 2 sided||||
1642133|NCT01879826|3018476|Non-Inferiority or Equivalence (legacy)|With a power of 0.8 and an acceptable type I error size of 0.05, 38 patients per group was estimated to achieve significance||||||0.044|||||||t-test, 2 sided||||
1642134|NCT01879579|3018506|Superiority or Other|||||||0.003|||||||Wilcoxon rank-sum test||||
1642135|NCT01879579|3018507|Superiority or Other|||||||0.008|||||||Generalized estimating equation modeling||||
1642136|NCT01879579|3018512|Superiority or Other|||||||0.13|||||||Wilcoxon rank-sum test||||
1642137|NCT01879579|3018513|Superiority or Other|||||||0.04|||||||Wilcoxon rank-sum test||||
1642138|NCT01879579|3018514|Superiority or Other|||||||0.78|||||||Wilcoxon rank-sum test||||
1642139|NCT01879579|3018515|Superiority or Other|||||||0.99|||||||Wilcoxon rank-sum test||||
1642140|NCT01879579|3018516|Superiority or Other|||||||0.007|||||||Interval-censoring survival analysis||||
1642141|NCT01879579|3018517|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1642142|NCT01879410|3018535|Superiority or Other||Mean Difference (Final Values)|0.101|||<|0.001|2-Sided|95.0|0.063|0.139|||ANCOVA||Least squares mean difference=UMEC/VI 62.5/25 mcg minus FSC 250/50 mcg.||
1642143|NCT01879371|3018536|Superiority or Other||Geometric mean ratio (net)|108.59|||||2-Sided|90.0|106.185|111.054|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and ‘subjects within sequences’ as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.|
1642144|NCT01879371|3018536|Superiority or Other||Geometric mean ratio (net)|106.5|||||2-Sided|90.0|104.05|109.004|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and ‘subjects within sequences’ as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.|
1642145|NCT01879371|3018537|Superiority or Other||Geometric mean ratio (net)|70.42|||||2-Sided|90.0|67.087|73.928|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and ‘subjects within sequences’ as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.|
1642146|NCT01879371|3018537|Superiority or Other||Geometric mean ratio (net)|99.65|||||2-Sided|90.0|93.874|105.776|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and ‘subjects within sequences’ as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.|
1642147|NCT01879371|3018538|Superiority or Other||Geometric mean ratio (net)|109.48|||||2-Sided|90.0|107.072|111.936|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen lysinate film-coated tablet '.|The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and ‘subjects within sequences’ as random effect. The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested.|
1642204|NCT01876810|3018778|Superiority or Other||Mean Difference (Final Values)|43.7|Standard Error of the Mean|26.5||0.4|2-Sided|95.0||||For all analyses, results were considered significant at p< 0.05|ANOVA|Repeated-measures ANOVA on Drug X Cue X Time were used|||
1642237|NCT01875991|3018907|Superiority or Other|||||||0.501|||||||Van Elteren test|P-value for 'All subjects' from Van Elteren test adjusting for strata (RA or PsO)|||
1642148|NCT01879371|3018538|Superiority or Other||Geometric mean ratio (net)|107.85|||||2-Sided|90.0|105.334|110.431|||||The geometric mean ratio is calculated as the geometric mean of 'Ibuprofen + Caffeine (FDC) tablet ' divided by the geometric mean of ' Ibuprofen acid film-coated tablet '.|"The ANOVA (analysis of variance) model on the logarithmic scale included effects accounting for the following sources of variation: ‘sequence’, ‘period’ and ‘treatment’ as fixed effects and ‘subjects within sequences’ as random effect.~The main focus was on estimation and not on testing, that is, formal statistical hypotheses were not tested."|
1642149|NCT01879319|3018544|Superiority or Other||LS Mean Treatment Difference|3.4|Standard Error of the Mean|3.2|||2-Sided|95.0|-2.9|9.7|||||||
1642150|NCT01879319|3018545|Superiority or Other||Treatment Difference|-2.4|||||2-Sided|95.0|-11.2|6.1|||||||
1642151|NCT01878214|3018599|Superiority or Other|||||||0.04|||||||Regression, Logistic|||Thinking about quitting|
1642152|NCT01878214|3018599|Superiority or Other|||||||0.09|||||||Regression, Logistic|||Motivation to quit|
1642153|NCT01878214|3018600|Superiority or Other|||||||0.28|||||||Regression, Logistic||||
1642154|NCT01878214|3018601|Superiority or Other|||||||0.3|||||||Regression, Logistic|||Smoking quantity|
1642155|NCT01878214|3018601|Superiority or Other|||||||0.63|||||||Regression, Logistic|||Smoking frequency|
1642156|NCT01878214|3018602|Superiority or Other|||||||0.79|||||||Regression, Logistic||||
1642157|NCT01878214|3018603|Superiority or Other|||||||0.76|||||||Chi-squared||||
1642158|NCT01878097|3018622|Superiority||F-stat|7.18||||0.0003|2-Sided||||||Mixed Models Analysis||||
1642159|NCT01878097|3018623|Superiority||F-stat|7.12||||0.0003|2-Sided||||||Mixed Models Analysis||||
1642160|NCT01877915|3018639|Superiority||Hazard Ratio (HR)|0.67||||0.253|2-Sided|95.0|0.33|1.34|||Log Rank|||Statistical Analysis 2 (Bleeding in Critical Space with Potential for Permanent Disability)|
1642161|NCT01877915|3018639|Superiority||Hazard Ratio (HR)|1.03||||0.951|2-Sided|95.0|0.41|2.59|||Log Rank|||Statistical Analysis 1 (Fatal Bleeding)|
1642162|NCT01877915|3018645|Superiority||Hazard Ratio (HR)|0.94||||0.27|2-Sided|95.0|0.84|1.05|||Log Rank|||Statistical Analysis 1|
1642163|NCT01877720|3018650|Superiority or Other||||||<|0.001|||||||Wilcoxon signed-rank test||||
1642164|NCT01877720|3018651|Superiority or Other||||||<|0.001|||||||Wilcoxon signed-rank test||||
1642165|NCT01877720|3018652|Superiority or Other|||||||0.67|||||||Paired t-test||||
1642166|NCT01877720|3018653|Superiority or Other|||||||0.012|||||||Paired t-test||||
1642167|NCT01877720|3018654|Superiority or Other|||||||0.003|||||||Paired t-test||||
1642168|NCT01877720|3018655|Superiority or Other|||||||0.002|||||||Paired t-test||||
1642169|NCT01877720|3018656|Superiority or Other|||||||0.003|||||||Paired t-test||||
1642170|NCT01877720|3018657|Superiority or Other|||||||0.74|||||||Paired t-test||||
1642171|NCT01877720|3018658|Superiority or Other|||||||0.001|||||||Paired t-test||||
1642172|NCT01877720|3018659|Superiority or Other||||||<|0.001|||||||Paired t-test||||
1642173|NCT01877668|3018698|Superiority or Other||Mean Difference (Net)|-0.2005|Standard Error of the Mean|0.06145||0.0012|2-Sided|95.0|-0.3213|-0.0797|||Mixed Models Analysis|No imputation.|||
1642174|NCT01877668|3018698|Superiority or Other||Mean Difference (Net)|-0.2196|Standard Error of the Mean|0.06184||0.0004|2-Sided|95.0|-0.3411|-0.098|||Mixed Models Analysis|No imputation.|||
1642175|NCT01877668|3018698|Superiority or Other||Mean Difference (Net)|-0.1697|Standard Error of the Mean|0.06173||0.0062|2-Sided|95.0|-0.291|-0.0483|||Mixed Models Analysis|No imputation.|||
1642176|NCT01877668|3018699|Superiority or Other||Risk Difference (RD)|18.55|Standard Error of the Mean|6.69||0.0055|2-Sided|95.0|5.45|31.66|||Large sample approximation|MR=NR|||
1642177|NCT01877668|3018699|Superiority or Other||Risk Difference (RD)|27.24|Standard Error of the Mean|6.64|<|0.0001|2-Sided|95.0|14.22|40.26|||Large sample approximation|MR=NR|||
1642178|NCT01877668|3018699|Superiority or Other||Risk Difference (RD)|17.13|Standard Error of the Mean|6.67|<|0.0102|2-Sided|95.0|4.06|30.21|||Large sample approximation|Missing response (MR)=non-response (NR)|||
1642179|NCT01877655|3018700|Superiority||Odds Ratio (OR)|1.18||||0.393|2-Sided|95.0|0.81|1.73||P value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazards Model||Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Analysis of all-cause mortality at 1 year. Participants with unknown survival status at 1 year were considered dead for this analysis.|
1642180|NCT01877655|3018701|Superiority||Hazard Ratio (HR)|-0.01||||0.928|2-Sided|95.0|-0.28|0.2||P value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazards Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment & randomization strata adjusted for death as a competing risk||Analysis of rate of adjudicated CMV AVT or CMV EOD. Time to first CMV-specific AVT was defined as time to the start of AVT for CMV viremia or CMV EOD. CMV-specific AVT and EOD and were determined by the adjudication committee. Rate based on cumulative incidence function estimate at 1 year.|
1642181|NCT01877655|3018702|Superiority||Odds Ratio (OR)|1.05||||0.802|2-Sided|95.0|0.73|1.51||P value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Cochran-Mantel-Haenszel||Odds ratio (ASP0113 vs placebo) and 95% CI based on CMH general association test stratified by donor recipient relatedness and donor CMV serostatus.|Analysis of composite of CMV viremia and adjudicated CMV-AVT. The CMV viremia was defined by the protocol as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. CMV-specific AVT was determined by the adjudication committee. Participants with no posttransplant viral load data were excluded from the analysis.|
1642182|NCT01877655|3018703|Superiority||Hazard Ratio (HR)|1.02||||0.888|2-Sided|95.0|0.8|1.29||P-value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazard Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment & randomization strata adjusted for death as a competing risk||Analysis of CMV-specific antiviral therapy (AVT) through 1 year. Time to first adjudicated CMV-specific therapy was defined as time to the start of AVT for CMV viremia. CMV-specific AVT was determined by the adjudication committee. Rate was based on cumulative incidence function estimate at 1 year.|
1642183|NCT01877655|3018704|Superiority||Hazard Ratio (HR)|0.96||||0.748|2-Sided|95.0|0.76|1.22||P-value based on cox proportional hazards model parameter estimate for the treatment effect.|Cox Proportional Hazard Model|Parameter estimate from cox proportional hazard model (ASP0113 v placebo) with treatment & randomization strata adjusted for death as a competing risk||Analysis of CMV viremia through 1 year posttransplant. CMV viremia was defined by the protocol as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. The 95% CI was based on cumulative incidence function CMV viremia rate at 1 year.|
1642184|NCT01877655|3018705|Superiority||Odds Ratio (OR)|1.27||||0.205|2-Sided|95.0|0.87|1.85||P-value based on CMH general association test stratified by donor-recipient relatedness and donor CMV serostatus.|Cochran-Mantel-Haenszel||Odds ratio (ASP0113 vs placebo) and 95% CI was based on CMH general association test stratified by donor-recipient relatedness & donor CMV serostatus.|Analysis of all-cause mortality and adjudicated CMV EOD. Analysis was completed using the Cochran-Mantel-Haenszel (CMH) test at the 1-sided 5% level stratified by use of antithymocyte globulin (ATG) and by receipt of a kidney from a living or deceased donor.|
1642185|NCT01877278|3018734|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1642186|NCT01877278|3018734|Superiority or Other||||||=|0|||||||t-test, 2 sided||||
1642187|NCT01877278|3018735|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1642188|NCT01877278|3018735|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1642189|NCT01877187|3018744|Other|||||||0.67||||||Statistical significance defined as p <= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642190|NCT01877187|3018744|Other|||||||0.013||||||Statistical significance defined as p <= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642191|NCT01877187|3018744|Other|||||||0.06||||||Statistical significance defined as p <= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642192|NCT01877187|3018746|Other|||||||0.94||||||Statistical significance defined as p <= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642193|NCT01877187|3018746|Other|||||||0.029||||||Statistical significance defined as p <= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642194|NCT01877187|3018746|Other|||||||0.02||||||Statistical significance defined as p <= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642195|NCT01877187|3018748|Other|||||||0.08||||||Statistical significance defined as p <= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642196|NCT01877187|3018748|Other|||||||0.017||||||Statistical significance defined as p <= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642197|NCT01877187|3018748|Other|||||||0.06||||||Statistical significance defined as p <= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642198|NCT01877187|3018750|Other|||||||0.94||||||Statistical significance defined as p <= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642199|NCT01877187|3018750|Other|||||||0.011||||||Statistical significance defined as p <= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642200|NCT01877187|3018750|Other|||||||0.19||||||Statistical significance defined as p <= 0.05. Data for 30 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642201|NCT01877187|3018752|Other|||||||0.034||||||Statistical significance defined as p <= 0.05. Data for 180 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642202|NCT01877187|3018752|Other|||||||0.09||||||Statistical significance defined as p <= 0.05. Data for 90 day timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642203|NCT01877187|3018752|Other|||||||0.06||||||Statistical significance defined as p <= .05. Result is for Day 30 timepoint.|Wilcoxon (Mann-Whitney)|||Sample size of 60 achieves 80% power to detect a Pearson correlation coefficient of 0.35 with a two-sided significant level of 0.05. Sample size of 30 will allow for detecting a Pearson correlation coefficient of 0.49 in each subgroup.|
1642205|NCT01876810|3018778|Superiority or Other||Mean Difference (Final Values)|51.3|Standard Error of the Mean|31.7||0.4|2-Sided|95.0|||||ANOVA|Repeated-measures ANOVA on Drug X Cue X Time were used|participants self-reportd VAS craving at the time of neutral cue presentation||
1642206|NCT01876810|3018779|Superiority or Other||Mean Difference (Final Values)|0.77|Standard Error of the Mean|0.05||0.9|2-Sided|95.0||||For all analyses, results were considered significant at p< 0.05|t-test, 2 sided||||
1642207|NCT01876810|3018779|Superiority or Other||Mean Difference (Final Values)|0.77|Standard Error of the Mean|0.034||0.9|2-Sided|95.0||||For all analyses, results were considered significant at p< 0.05|t-test, 2 sided||||
1642208|NCT01876810|3018780|Superiority or Other||Median Difference (Final Values)|0.0|Standard Error of the Mean|0.0||0.1|2-Sided|95.0||||For all analyses, results were considered significant at p< 0.05|t-test, 2 sided||||
1642209|NCT01876810|3018780|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.1||0.1|2-Sided|95.0||||For all analyses, results are considered significant at p<.05.|t-test, 2 sided||||
1642210|NCT01876784|3018791|Superiority or Other (legacy)||Hazard Ratio (HR)|0.75||||0.08|2-Sided|95.0|0.55|1.03||Threshold for significance at 0.05 level.|Log Rank||Vandetanib 300 mg vs Placebo|A multiple testing procedure (MTP) with an alpha-exhaustive recycling strategy was employed to provide adequate control of type I error.|
1642211|NCT01876732|3018792|Superiority or Other|||||||0.358||||||"p-value of  SF-12 mental composite "|Wilcoxon signed-rank test||||
1642212|NCT01876732|3018792|Superiority or Other|||||||0.583||||||"P-value of  SF-12 physical composite "|Wilcoxon signed-rank test||||
1642213|NCT01876732|3018792|Superiority or Other|||||||0.084||||||"P-value of  energy/fatigue "|Wilcoxon signed-rank test||||
1642214|NCT01876732|3018792|Superiority or Other|||||||0.156||||||"P-value of  role-emotional "|Wilcoxon signed-rank test||||
1642215|NCT01876732|3018792|Superiority or Other|||||||0.858||||||"P-value of  emotional well-being "|Wilcoxon signed-rank test||||
1642216|NCT01876732|3018792|Superiority or Other|||||||0.169||||||"P-value of  general health "|Wilcoxon signed-rank test||||
1642217|NCT01876732|3018792|Superiority or Other|||||||0.424||||||"P-value of  pain "|Wilcoxon signed-rank test||||
1642218|NCT01876732|3018792|Superiority or Other|||||||0.438||||||"P-value of  role-physical "|Wilcoxon signed-rank test||||
1642219|NCT01876732|3018792|Superiority or Other|||||||0.391||||||"P-value of  physical functioning "|Wilcoxon signed-rank test||||
1642220|NCT01876732|3018792|Superiority or Other|||||||0.09||||||"P-value of  patient satisfaction "|Wilcoxon signed-rank test||||
1642221|NCT01876732|3018792|Superiority or Other|||||||1||||||"P-value of  overall health "|Wilcoxon signed-rank test||||
1642222|NCT01876732|3018792|Superiority or Other|||||||0.943||||||"P-value of  dialysis staff encouragement "|Wilcoxon signed-rank test||||
1642223|NCT01876732|3018792|Superiority or Other|||||||1||||||"P-value of  social support "|Wilcoxon signed-rank test||||
1642224|NCT01876732|3018792|Superiority or Other|||||||1||||||"P-value of  sleep "|Wilcoxon signed-rank test||||
1642225|NCT01876732|3018792|Superiority or Other|||||||0.281||||||"P-value of  quality of social interaction "|Wilcoxon signed-rank test||||
1642226|NCT01876732|3018792|Superiority or Other|||||||0.895||||||"P-value of  cognitive function "|Wilcoxon signed-rank test||||
1642227|NCT01876732|3018792|Superiority or Other|||||||0.25||||||"P-value of  work status "|Wilcoxon signed-rank test||||
1642228|NCT01876732|3018792|Superiority or Other|||||||0.301||||||"P-value of  burden of kidney disease "|Wilcoxon signed-rank test||||
1642229|NCT01876732|3018792|Superiority or Other|||||||0.772||||||"P- value of  effects of kidney disease "|Wilcoxon signed-rank test||||
1642230|NCT01876732|3018792|Superiority or Other|||||||0.688||||||"P- value of  symptom/problem list "|Wilcoxon signed-rank test||||
1642231|NCT01876732|3018792|Superiority or Other|||||||0.047||||||"P- value for social function"|Wilcoxon signed-rank test||||
1642232|NCT01876485|3018820|Superiority||Mean Difference (Final Values)|0.32||||0.003|2-Sided||||||proc mixed in SAS (multilevel modeling)|||We compared group differences in DDS at 10 months. The value of DDS at 10 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.|
1642233|NCT01876485|3018820|Superiority||Mean Difference (Final Values)|0.3||||0.003|2-Sided||||||proc mixed in SAS (multilevel modeling)|||We compared group differences in DDS at 4 months. The value of DDS at 4 months was the dependent variable, treatment group was the independent variable, and baseline DDS was a covariate. Power calculations were based on effect sizes for the DDS in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n=138 EPIC, n=135 EUC) exceed the required 130 per group.|
1642234|NCT01876485|3018821|Superiority||Mean Difference (Final Values)|0.11||||0.6|2-Sided||||||proc mixed in SAS (multilevel modeling)|Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.||"We compared group differences in HbA1c at 10 months. The value of HbA1c at 10 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate.~Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group."|
1642235|NCT01876485|3018821|Superiority||Mean Difference (Final Values)|0.43||||0.003|2-Sided||||||proc mixed in SAS (multilevel modeling)|Numerator degrees of freedom = 1 for both models (4mo and 10mo) and denominator degrees of freedom vary based on multiple imputation.||"We compared group differences in HbA1c at 4. The value of HbA1c at 4 months was the dependent variable, treatment group was the independent variable, and baseline HbA1c was a covariate.~Power calculations were based on effect sizes for the HbA1c in similar trial that revealed small-to-medium effect sizes. Our goal was to include 130 patients in each arm. The randomized samples (n = 140 EPIC, n = 140 EUC) exceed the required 130 per group."|
1642236|NCT01876368|3018849|Superiority or Other||Mean Difference (Net)|-3.19|Standard Error of the Mean|0.78|<|0.001|2-Sided|95.0|-4.73|-1.65|||ANCOVA||||
1642238|NCT01875978|3018909|Superiority or Other||||||<|0.05||||||P value <0.05 for statistical significance|t-test, 1 sided|Student's t-test, 1 sided||Hypothesis:phytosterols increase endothelial progenitor cells to provide endothelial repair and vessel protection|
1642239|NCT01875978|3018910|Superiority or Other||||||<|0.05||||||P<0.05 for statistical significance|t-test, 1 sided|Student's t test, 1 sided||Phytosterols increase IGF-1|
1642240|NCT01875978|3018911|Superiority or Other||||||<|0.05||||||P value <0.05 for statistical significance|t-test, 1 sided|Student's t test, 1 sided||Hypothesis: phytosterols increase the anti-oxidative capacity.|
1642241|NCT01875978|3018912|Superiority or Other||||||<|0.05||||||P-value <0.05 is significance meaningful.|t-test, 1 sided|Student's t-test, 1 sided||Hypothesis: phytosterols improve metabolic status|
1642242|NCT01875861|3018916|Superiority||Odds Ratio (OR)|1.2|||||2-Sided|95.0|1.03|1.39||||||See comments about time series analysis for primary outcome measure. Repeated measures regression analysis of the likelihood of monitoring for each time period was conducted.|
1642243|NCT01875861|3018917|Superiority||Odds Ratio (OR)|1.19|||||2-Sided|95.0|1.02|1.38||||||Because of data discontinuity, assumptions for time series analysis did not hold. Repeated measures regression models were developed to compare overall weight monitoring rates at baseline across the implementation phases.|
1642244|NCT01875731|3018924|Superiority or Other||Odds Ratio (OR)|0.7||||0.71|2-Sided|95.0|0.1|4.09|||Chi-squared||||
1642245|NCT01875731|3018925|Superiority or Other||Odds Ratio (OR)|5.09||||0.01|2-Sided|95.0|1.57|16.8|||Chi-squared||||
1642246|NCT01875159|3018945|Superiority or Other||||||<|0.05|||||||GEE gamma regression models|||>80% probability of detecting at least a 36% reduction in intermittent hypoxia events/hour of recording and in sec/hour <90% oxygen saturation/hour of recording|
1642247|NCT01874951|3018947|Non-Inferiority or Equivalence|An initial power analysis at the time of protocol development suggested that with 6 patients in each treatment group, we could expect a 79% chance of achieving significance (2-sided p < 0.05) if the true response rate to low-dose naltrexone (LDN) was 80% and the true placebo response rate was 20%.||||||0.55||||||Threshold of statistical significance is 0.05.|Chi-squared|Chi-squared value was 1.5.||Response rates were based on attaining a reduction in the HAM-D-17 scale of 50% or greater compared to baseline. We hypothesized that naltrexone would produce a significantly greater response rate than placebo.|
1642248|NCT01874535|3018972|Superiority or Other||Hazard Ratio (HR)|0.009|||<|0.05|2-Sided||||||Chi-squared||||
1642249|NCT01874353|3018974|Superiority or Other (legacy)||Hazard Ratio (HR)|0.3|||<|0.0001|2-Sided|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio < 1 favours olaparib||
1642250|NCT01874353|3018975|Superiority or Other (legacy)||Hazard Ratio (HR)|0.31|||<|0.0001|2-Sided|95.0|0.23|0.42||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio < 1 favours olaparib||
1642251|NCT01874353|3018976|Superiority or Other (legacy)||Hazard Ratio (HR)|0.37|||<|0.0001|2-Sided|95.0|0.26|0.53||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio < 1 favours olaparib||
1642252|NCT01874353|3018977|Superiority or Other (legacy)||Hazard Ratio (HR)|0.28|||<|0.0001|2-Sided|95.0|0.21|0.38||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio < 1 favours olaparib||
1642253|NCT01874353|3018978|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.03||||0.9765|2-Sided|95.0|-2.191|2.126|||Mixed Models Analysis|Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.|||
1642254|NCT01874353|3018979|Superiority or Other (legacy)||Hazard Ratio (HR)|0.5||||0.0002|2-Sided|95.0|0.34|0.72||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio < 1 favours olaparib||
1642255|NCT01874353|3018980|Superiority or Other (legacy)||Hazard Ratio (HR)|0.3|||<|0.0001|2-Sided|95.0|0.23|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio < 1 favours olaparib||
1642256|NCT01874353|3018981|Superiority or Other (legacy)||Hazard Ratio (HR)|0.8||||0.4267|2-Sided|95.0|0.5|1.31||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio <1 favours olaparib||
1642257|NCT01874353|3018982|Superiority or Other (legacy)||Hazard Ratio (HR)|0.3|||<|0.0001|2-Sided|95.0|0.22|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment|Regression, Cox|Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy|A hazard ratio < 1 favours olaparib||
1642258|NCT01874275|3018991|Superiority or Other|||||||0.2413|||||||Mixed Models Analysis||||
1642259|NCT01874262|3018994|Superiority or Other|||||||0.025|||||||Wilcoxon (Mann-Whitney)||||
1642260|NCT01874145|3019006|Superiority or Other||Mean Difference (Final Values)|-2.058|Standard Error of the Mean|1.206||0.0897|2-Sided|95.0|-4.438|0.322||The overall significance level for this study was 5% using 2-tailed test.|ANCOVA|In addition to treatment group, month (categorical), treatment-by-month interaction and score at baseline were used as covariates.|GA 40 mg/mL TIW treatment group vs. GA 20 mg/mL QD treatment group.|"To control for type 1 errors, secondary variables were analyzed only if analysis of the primary variable was statistically significant. Gate-keeping procedures offered further control with this hierarchy:~the rate of ISRs~change from baseline to month 4 (change - M4) in MSIS-20 physical wellbeing~change - M4 in MSIS-20 psychological wellbeing~change - M4 in TSQM-9 convenience~change - M4 in TSQM-9 overall satisfaction"|
1642261|NCT01874145|3019007|Superiority or Other||Risk Ratio (RR)|0.5|Standard Error of the Mean|0.101||0.0006|2-Sided|95.0|0.337|0.742||The overall significance level for this study was 5% using 2-tailed test.|Poisson regression model|Natural log of treatment duration was an offset variable; adjusted for baseline EDSS, treatment group, age, sex, # relapses 2 years prior to screening|GA 40 mg/mL TIW treatment group / GA 20 mg/mL QD treatment group|Adjusted mean estimates were adjusted estimates of event rates within treatment group. The treatment effect parameter estimate was a risk ratio of the GA 40 mg/mL TIW treatment group divided by the GA 20 mg/mL QD treatment group. The p value tested whether the risk ratio was significantly different from 1.|
1642262|NCT01874145|3019009|Superiority or Other||Risk Ratio (RR)|0.501|Standard Error of the Mean|0.101||0.0006|2-Sided|95.0|0.338|0.743||The overall significance level for this study was 5% using 2-tailed test.|Poisson regression model|Natural log of treatment duration was an offset variable; adjusted for baseline EDSS, treatment group, age, sex, # relapses 2 years prior to screening|GA 40 mg/mL TIW treatment group / GA 20 mg/mL QD treatment group.|Adjusted mean estimates were adjusted estimates of event rates within treatment group. The treatment effect parameter estimate was a risk ratio of the GA 40 mg/mL TIW treatment group divided by the GA 20 mg/mL QD treatment group. The p value tested whether the risk ratio was significantly different from 1.|
1642263|NCT01873950|3019030|Superiority or Other||||||<|0.05||||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.|||
1642264|NCT01873950|3019031|Superiority or Other||||||<|0.05||||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.|||
1642265|NCT01873950|3019032|Superiority or Other||||||<|0.05||||||For each ECG biomarker and treatment, the null hypothesis is that there is no difference in the biomarker change from baseline between the treatment and placebo.|Mixed Models Analysis|For each ECG biomarker and treatment, the placebo-corrected change from baseline was computed using linear mixed effect model.|||
1642266|NCT01873742|3019040|Other|The BDI's Cronbach's alpha was .93 at start of therapy, and .95 at the end of therapy.|Mean Difference (Final Values)|1.01|||<|0.05|2-Sided||||||Mixed Models Analysis||||
1642267|NCT01872910|3019070|Superiority or Other (legacy)||Cox Proportional Hazard|0.08|||||2-Sided|95.0|0.03|0.21|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.||
1642268|NCT01872910|3019070|Superiority or Other (legacy)||Cox Proportional Hazard|4.16|||||2-Sided|95.0|2.04|8.47|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.||
1642269|NCT01872910|3019070|Superiority or Other (legacy)||Cox Proportional Hazard|0.33|||||2-Sided|95.0|0.12|0.88|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.||
1642270|NCT01872910|3019071|Superiority or Other (legacy)||Cox Proportional Hazard|0.36|||||2-Sided|95.0|0.19|0.67|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.||
1642271|NCT01872910|3019071|Superiority or Other (legacy)||Cox Proportional Hazard|2.15|||||2-Sided|95.0|1.19|3.88|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.||
1642272|NCT01872910|3019071|Superiority or Other (legacy)||Cox Proportional Hazard|0.78|||||2-Sided|95.0|0.41|1.47|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.||
1642273|NCT01872910|3019072|Superiority or Other (legacy)||Cox Proportional Hazard|1.22|||||2-Sided|95.0|0.57|2.59|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.||
1642274|NCT01872910|3019072|Superiority or Other (legacy)||Cox Proportional Hazard|5.48|||||2-Sided|95.0|2.69|11.16|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.||
1642275|NCT01872910|3019072|Superiority or Other (legacy)||Cox Proportional Hazard|0.34|||||2-Sided|95.0|0.16|0.72|||||HR of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.||
1642276|NCT01872910|3019072|Superiority or Other (legacy)||Cox Proportional Hazard|1.85|||||2-Sided|95.0|0.99|3.46|||||Hazard ratio (HR) of the treatment differences were estimated based on Cox proportional hazard model including treatment and baseline pain intensity (VAS) as fixed effects.||
1642277|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|4.1|||||2-Sided|95.0|-6.8|15.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.||
1642278|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|0.9|||||2-Sided|95.0|-3.9|5.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.||
1642279|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|0.2|||||2-Sided|95.0|-2.9|3.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.||
1642280|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-2.2|2.1|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.||
1642281|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.3|||||2-Sided|95.0|-1.6|1.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.||
1642282|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|21.9|||||2-Sided|95.0|11.5|32.2|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.||
1642283|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|-14.1|||||2-Sided|95.0|-24.7|-3.6|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.||
1642284|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|7.8|||||2-Sided|95.0|-2.6|18.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 24 h.||
1642285|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|11.6|||||2-Sided|95.0|7.0|16.5|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.||
1642286|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|-8.2|||||2-Sided|95.0|-12.9|-3.5|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.||
1642287|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|3.4|||||2-Sided|95.0|-1.3|8.1|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 12 h.||
1642288|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|8.0|||||2-Sided|95.0|5.1|10.9|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.||
1642289|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|-6.1|||||2-Sided|95.0|-9.0|-3.3|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.||
1642290|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|1.9|||||2-Sided|95.0|-1.0|4.8|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 8 h.||
1642291|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|5.9|||||2-Sided|95.0|3.8|8.0|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.||
1642292|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|-4.8|||||2-Sided|95.0|-6.8|-2.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.||
1642293|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|1.1|||||2-Sided|95.0|-0.9|3.2|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 6 h.||
1642294|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|3.5|||||2-Sided|95.0|2.3|4.8|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.||
1642295|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|-2.9|||||2-Sided|95.0|-4.1|-1.7|||||95% CrI is reported here, not the CI. Estimation is for SPID 0 to 4 h.||
1642296|NCT01872910|3019073|Superiority or Other (legacy)||Mean Difference (Final Values)|0.6|||||2-Sided|95.0|-0.6|1.9|||||95% CrI is reported here, not the CI. Estimation is SPID 0 to 4 h.||
1642297|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|7.8|||||2-Sided|95.0|-8.4|24.2|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.||
1642298|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|5.9|||||2-Sided|95.0|-9.2|21.1|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.||
1642299|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|4.5|||||2-Sided|95.0|-9.9|19.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 8 h.||
1642300|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|3.5|||||2-Sided|95.0|-9.8|16.8|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.||
1642301|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|1.6|||||2-Sided|95.0|-9.7|12.9|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.||
1642302|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|42.6|||||2-Sided|95.0|28.6|56.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.||
1642303|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|-30.2|||||2-Sided|95.0|-44.0|-16.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.||
1642304|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|12.4|||||2-Sided|95.0|-1.6|26.2|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 24 h.||
1642305|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|43.5|||||2-Sided|95.0|31.3|55.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.||
1642306|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|-32.7|||||2-Sided|95.0|-45.1|-20.3|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.||
1642307|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|10.7|||||2-Sided|95.0|-1.0|23.0|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 12 h.||
1642308|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|42.5|||||2-Sided|95.0|32.1|52.7|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.||
1642309|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|-35.1|||||2-Sided|95.0|-45.6|-24.6|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.||
1642310|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|7.3|||||2-Sided|95.0|-2.9|17.6|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 6 h.||
1642311|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|37.3|||||2-Sided|95.0|27.8|46.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.||
1642412|NCT01869699|3019332|Superiority||Mean Difference (Final Values)|-17.0|||<|0.001|2-Sided|95.0|-25.0|-8.0|||ANCOVA||||
1642312|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|-32.0|||||2-Sided|95.0|-41.5|-22.4|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.||
1642313|NCT01872910|3019074|Superiority or Other (legacy)||Mean Difference (Final Values)|5.3|||||2-Sided|95.0|-4.2|14.5|||||95% CrI is reported here, not the CI. Estimation is for weighted mean change from baseline pain intensity for 0 to 4 h.||
1642314|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-7.0|||||2-Sided|95.0|-21.4|7.6|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.||
1642315|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-2.1|||||2-Sided|95.0|-8.3|4.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.||
1642316|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.8|||||2-Sided|95.0|-4.7|3.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.||
1642317|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.3|||||2-Sided|95.0|-2.9|2.4|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.||
1642318|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-1.5|1.6|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.||
1642319|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-39.4|||||2-Sided|95.0|-53.2|-25.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.||
1642320|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|23.1|||||2-Sided|95.0|9.0|37.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.||
1642321|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-16.3|||||2-Sided|95.0|-30.8|-2.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 24 h.||
1642322|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-19.7|||||2-Sided|95.0|-25.9|-13.5|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.||
1642323|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|12.9|||||2-Sided|95.0|6.6|19.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.||
1642324|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-6.8|||||2-Sided|95.0|-13.2|0.5|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 12 h.||
1642325|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-13.1|||||2-Sided|95.0|-16.9|-9.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.||
1642326|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|9.2|||||2-Sided|95.0|5.3|13.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.||
1642327|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-4.0|||||2-Sided|95.0|-7.9|-0.1|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 8 h.||
1642328|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-9.6|||||2-Sided|95.0|-12.2|-6.9|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.||
1642329|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|7.1|||||2-Sided|95.0|4.4|9.8|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.||
1642330|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-2.5|||||2-Sided|95.0|-5.2|0.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 6 h.||
1642331|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-5.9|||||2-Sided|95.0|-7.4|-4.3|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.||
1642332|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|4.5|||||2-Sided|95.0|2.9|6.0|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.||
1642333|NCT01872910|3019075|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.3|||||2-Sided|95.0|-2.9|0.2|||||95% CrI is reported here, not the CI. Estimation is for TOPAR 0 to 4 h.||
1642334|NCT01872910|3019076|Superiority or Other (legacy)||Mean Difference (Final Values)|43.6|||||2-Sided|95.0|32.7|54.9|||||95% CrI is reported here, not the CI.||
1642335|NCT01872910|3019076|Superiority or Other (legacy)||Mean Difference (Final Values)|-34.6|||||2-Sided|95.0|-45.7|-23.2|||||95% CrI is reported here, not the CI.||
1642336|NCT01872910|3019076|Superiority or Other (legacy)||Mean Difference (Final Values)|9.0|||||2-Sided|95.0|-2.1|20.0|||||95% CrI is reported here, not the CI.||
1642337|NCT01872689|3019087|Superiority||Hazard Ratio (HR)|0.68||||0.1976|2-Sided|95.0|0.37|1.23|||Log Rank|||Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)|
1642338|NCT01872689|3019087|Superiority||Hazard Ratio (HR)|0.72||||0.5685|2-Sided|95.0|0.23|2.26|||Log Rank|||Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)|
1642339|NCT01872689|3019089|Superiority||Hazard Ratio (HR)|0.89||||0.6815|2-Sided|95.0|0.52|1.54|||Log Rank|||Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)|
1642340|NCT01872689|3019091|Superiority||Hazard Ratio (HR)|0.45||||0.1346|2-Sided|95.0|0.16|1.31|||Log Rank|||Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)|
1642341|NCT01872689|3019091|Superiority||Hazard Ratio (HR)|1.07||||0.9366|2-Sided|95.0|0.21|5.3|||Log Rank|||Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)|
1642342|NCT01872689|3019093|Superiority||Hazard Ratio (HR)|0.84||||0.4433|2-Sided|95.0|0.54|1.31|||Log Rank|||Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)|
1642343|NCT01872689|3019095|Superiority||Mean Difference (Final Values)|-0.16313|Standard Error of the Mean|1.37698||0.9057|2-Sided|95.0|-2.87|2.55|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.|
1642368|NCT01871805|3019141|Superiority|||||||0.0251||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided||||
1642413|NCT01869699|3019333|Superiority||Mean Difference (Final Values)|-6.0||||0.03|2-Sided|95.0|-10.0|-1.0|||ANCOVA||||
1642344|NCT01872689|3019095|Superiority||Median Difference (Final Values)|-2.10204|Standard Error of the Mean|2.41325||0.3854|2-Sided|95.0|-6.88|2.68|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.|
1642345|NCT01872689|3019096|Superiority||Mean Difference (Final Values)|21.72972|Standard Error of the Mean|31.68767||0.4934|2-Sided|95.0|-40.65|84.11|||Mixed Models Analysis||Mean Difference = Lebrikizumab - Placebo|Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.|
1642346|NCT01872689|3019096|Superiority||Median Difference (Final Values)|28.12302|Standard Error of the Mean|49.47253||0.5707|2-Sided|95.0|-69.8|126.04|||Mixed Models Analysis||Mean Difference = Lebrikizumab - Placebo|Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.|
1642347|NCT01872689|3019097|Superiority||Hazard Ratio (HR)|1.01||||0.9344|2-Sided|95.0|0.72|1.42|||Log Rank|||Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)|
1642348|NCT01872689|3019097|Superiority||Hazard Ratio (HR)|0.65||||0.0972|2-Sided|95.0|0.39|1.09|||Log Rank|||Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)|
1642349|NCT01872689|3019099|Superiority||Mean Difference (Final Values)|0.18203|Standard Error of the Mean|0.65206||0.7803|2-Sided|95.0|-1.1|1.47|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.|
1642350|NCT01872689|3019099|Superiority||Median Difference (Final Values)|0.54171|Standard Error of the Mean|1.05201||0.6075|2-Sided|95.0|-1.54|2.62|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.|
1642351|NCT01872689|3019100|Superiority||Hazard Ratio (HR)|0.84||||0.3751|2-Sided|95.0|0.56|1.24|||Log Rank|||Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)|
1642352|NCT01872689|3019100|Superiority||Hazard Ratio (HR)|0.79||||0.4299|2-Sided|95.0|0.44|1.41|||Log Rank|||Stratified Analysis: stratified by baseline FVC (<50%, 50 to 75%, >75%)|
1642353|NCT01872689|3019102|Superiority||Mean Difference (Final Values)|-21.4127|Standard Error of the Mean|16.8016||0.2036|2-Sided|95.0|-54.5|11.67|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.|
1642354|NCT01872689|3019102|Superiority||Median Difference (Final Values)|21.93023|Standard Error of the Mean|21.62248||0.3129|2-Sided|95.0|-20.97|64.83|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.|
1642355|NCT01872689|3019103|Superiority||Mean Difference (Final Values)|0.49998|Standard Error of the Mean|0.84946||0.5566|2-Sided|95.0|-1.17|2.17|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.|
1642356|NCT01872689|3019103|Superiority||Median Difference (Final Values)|0.98111|Standard Error of the Mean|1.31064||0.4555|2-Sided|95.0|-1.61|3.57|||Mixed Models Analysis|||Mixed Linear model comparing Lebrikizumab to Placebo, with assessment as the outcome variable; assessment time by treatment as fixed effects; and participant baseline FVC (<50%, 50 to 75%, >75%) and participant by assessment time as random effects with unstructured covariance.|
1642357|NCT01872611|3019108|Superiority or Other||Odds Ratio (OR)|0.4|Standard Error of the Mean|0.1||0.001|2-Sided|95.0|0.2|0.7|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for EU registration and secondary for US registration.|
1642358|NCT01872611|3019109|Superiority or Other||Odds Ratio (OR)|0.9|Standard Error of the Mean|0.2||0.671|2-Sided|95.0|0.7|1.3|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for United States (US) registration and secondary for European Union (EU) registration.|
1642359|NCT01872338|3019110|Superiority|||||||0.23||||||repeated measures, overall time by condition effect|Regression, Linear||||
1642360|NCT01872338|3019111|Superiority|||||||0.34|||||||Regression, Linear|repeated measures, overall time by condition effect|||
1642361|NCT01872338|3019112|Superiority||Incident Rate Ratio|0.43||||0.01|2-Sided|95.0|0.22|0.82|||negative binomial regression||||
1642362|NCT01872338|3019113|Superiority||Incident Rate Ratio|0.5||||0.015|2-Sided|95.0|0.29|0.87|||negative binomial regression||||
1642363|NCT01872078|3019114|Superiority or Other||Ratio (%)|47.99|||||2-Sided|95.0|32.73|70.36||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%|
1642364|NCT01872078|3019114|Superiority or Other||Ratio (%)|78.76|||||2-Sided|95.0|53.41|116.16||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%|
1642365|NCT01872078|3019114|Superiority or Other||Ratio (%)|87.04|||||2-Sided|95.0|58.52|129.47||||||The null hypothesis is that the ratio of Active to Control in LH AUC(0-8) ratio to baseline at day 7= 100%|
1642366|NCT01871805|3019139|Superiority|||||||0.001||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided||||
1642367|NCT01871805|3019141|Superiority|||||||0.0203||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided||||
1642369|NCT01871805|3019142|Superiority|||||||0.0056||||||Tests null hypothesis that the response rate is equal to 35% versus the alternative hypothesis that the response rate is not equal to 35%.|Exact Clopper-Pearson CI, 2 sided||||
1642370|NCT01871558|3019151|Superiority or Other|||||||0.139|||||||Chi-squared||||
1642371|NCT01871402|3019201|Superiority or Other||||||<|0.001||||||Statistical significance (<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevations).|Cochran-Mantel-Haenszel|||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).|
1642372|NCT01871402|3019202|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1642373|NCT01871402|3019203|Superiority or Other||||||<|0.001||||||Statistical significance (<0.001) was achieved for each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).|Cochran-Mantel-Haenszel|Missing data was imputed as treatment failure.||Treatment groups were compared with respect to each of the clinical signs of psoriasis (scaling, erythema, and plaque elevation).|
1642374|NCT01871402|3019204|Superiority or Other||||||<|0.001||||||Treatment groups were compared with respect to the proportions of subjects with “treatment success” at Day 15 using the Cochran-Mantel-Haenszel (CMH) test stratified by analysis center.|Cochran-Mantel-Haenszel|Multiple imputation was used to impute missing data from the ITT population.|||
1642375|NCT01871285|3019205|Superiority or Other||Mean Difference (Final Values)|0.683||||0.6155|2-Sided|95.0|-11.89|13.25|||Mixed Models Analysis||||
1642376|NCT01871285|3019205|Superiority or Other||Mean Difference (Final Values)|-0.182||||0.7942|2-Sided|95.0|-1.6|1.24|||Mixed Models Analysis||||
1642377|NCT01871285|3019206|Superiority or Other||Mean Difference (Final Values)|0.683||||0.6155|2-Sided|95.0|-11.89|13.25|||Mixed Models Analysis||||
1642378|NCT01871285|3019206|Superiority or Other||Mean Difference (Final Values)|-0.182||||0.7942|2-Sided|95.0|-1.6|1.24|||Mixed Models Analysis||||
1642379|NCT01871077|3019215|Other|||||||0.497|||||||Wilcoxon (Mann-Whitney)||||
1642380|NCT01871077|3019216|Other|||||||1|||||||Friedman test||||
1642381|NCT01871077|3019217|Other|||||||0.078|||||||Wilcoxon (Mann-Whitney)||||
1642382|NCT01871077|3019218|Other|||||||0.89|||||||Friedman test||||
1642383|NCT01870778|3019253|Superiority||Ratio of RLX030 to placebo|0.9863||||0.375|2-Sided|95.0|0.9567|1.0169|||Repeated measures model|||Day 14|
1642384|NCT01870778|3019253|Superiority||Ratio of RLX030 to placebo|0.9922||||0.5361|2-Sided|95.0|0.9677|1.0172|||Repeated measures model|||Day 5|
1642385|NCT01870778|3019253|Superiority||Ratio of RLX030 to placebo|0.9637||||0.0003|2-Sided|95.0|0.9447|0.983|||Repeated measures model|||Day 2|
1642386|NCT01870778|3019254|Superiority||Ratio of RLX030 to placebo|0.9543||||0.3893|2-Sided|95.0|0.8578|1.0617|||Repeated measures model|||Day 14|
1642387|NCT01870778|3019254|Superiority||Ratio of RLX030 to placebo|0.9539||||0.3709|2-Sided|95.0|0.86|1.0579|||Repeated measures model|||Day 5|
1642388|NCT01870778|3019254|Superiority||Ratio of RLX030 to placebo|0.8597||||0.0007|2-Sided|95.0|0.7876|0.9385|||Repeated measures model|||Day 2|
1642389|NCT01870778|3019255|Superiority||Ratio of RLX030 to placebo|0.9074||||0.0209|2-Sided|95.0|0.8355|0.9854|||Repeated measures model|||Day 14|
1642390|NCT01870778|3019255|Superiority||Ratio of RLX030 to placebo|0.898||||0.0034|2-Sided|95.0|0.8358|0.9649|||Repeated measures model|||Day 5|
1642391|NCT01870778|3019255|Superiority||Ratio of RLX030 to placebo|0.9401||||0.0209|2-Sided|95.0|0.8921|0.9907|||Repeated measures model|||Day 2|
1642392|NCT01870778|3019256|Superiority||Hazard Ratio (HR)|1.04||||0.2158|2-Sided|95.0|0.98|1.1|||Log Rank|2-sided p-value||Peripheral edema, pre-sacral edema|
1642393|NCT01870778|3019256|Superiority||Hazard Ratio (HR)|1.08||||0.0196|2-Sided|95.0|1.01|1.15|||Log Rank|2-sided p-value||Jugular venous pressure|
1642394|NCT01870778|3019256|Superiority||Hazard Ratio (HR)|1.0||||0.9962|2-Sided|95.0|0.95|1.05|||Log Rank|2-sided p-value||Rales|
1642395|NCT01870778|3019256|Superiority||Hazard Ratio (HR)|1.08||||0.0051|2-Sided|95.0|1.02|1.14|||Log Rank|2-sided p-value||Orthopnea|
1642396|NCT01870778|3019256|Superiority||Hazard Ratio (HR)|1.08||||0.005|2-Sided|95.0|1.02|1.14|||Log Rank|2-sided p-value||Exertional dyspnea|
1642397|NCT01870778|3019257|Superiority|||||||0.2103|||||||Wilcoxon rank sum test|2-sided p-value|||
1642398|NCT01870778|3019258|Superiority||Hazard Ratio (HR)|0.97||||0.2744|2-Sided|95.0|0.88|1.07||Adjusted p-value based on multiple testing procedure|Log Rank||||
1642399|NCT01870778|3019259|Superiority|||||||0.2204||||||Based on multiple testing procedure|Wilcoxon rank sum test|One-sided p-value|||
1642400|NCT01870778|3019260|Superiority||Hazard Ratio (HR)|0.94||||0.389|2-Sided|95.0|0.81|1.08|||Log Rank|2-sided p-value|||
1642401|NCT01870778|3019261|Superiority||Hazard Ratio (HR)|0.89||||0.0968|2-Sided|95.0|0.75|1.07||Adjusted p-value based on multiple testing procedure|Gehan's generalized Wilcoxon test|One-sided p-value|||
1642402|NCT01870778|3019262|Superiority||Hazard Ratio (HR)|0.98||||0.3857|2-Sided|95.0|0.83|1.15||Adjusted alpha p-value based on multiple testing procedure.|Log Rank|One-sided p-value|||
1642403|NCT01870739|3019270|Superiority or Other||Mean Difference (Net)|-0.0812||||0.7946|2-Sided|95.0|-0.6987|0.5362|||Linear Model|Treatment as a fixed effect and corresponding baseline as a covariate|||
1642404|NCT01870739|3019271|Superiority or Other||Mean Difference (Net)|-0.0371||||0.8614|2-Sided|95.0|-0.4582|0.3839|||Linear Model|Treatment as a fixed effect and corresponding baseline as a covariate|||
1642405|NCT01870739|3019272|Superiority or Other||Mean Difference (Net)|-0.0616||||0.7324|2-Sided|95.0|-0.4178|0.2947|||Linear Model|Treatment as fixed effect and corresponding baseline as covariate.|||
1642406|NCT01869764|3019322|Other|||||||0.29|||||||ANOVA||||
1642407|NCT01869764|3019323|Other|||||||0.93|||||||ANOVA||||
1642408|NCT01869699|3019328|Superiority||Mean Difference (Final Values)|-8.0||||0.02|2-Sided|95.0|-15.0|-1.0|||ANCOVA||||
1642409|NCT01869699|3019329|Superiority||Mean Difference (Final Values)|-24.0||||0.001|2-Sided|95.0|-38.0|-10.0|||ANCOVA||||
1642410|NCT01869699|3019330|Superiority||Mean Difference (Final Values)|-0.6||||0.002|2-Sided|95.0|-1.0|-0.3|||ANCOVA||||
1642411|NCT01869699|3019331|Superiority||Mean Difference (Final Values)|-1.0||||0.42|2-Sided|95.0|-4.0|12.0|||ANCOVA||||
1642414|NCT01869699|3019334|Superiority||Mean Difference (Final Values)|-0.47||||0.002|2-Sided|95.0|-0.76|-0.18|||ANCOVA|||We estimated that 20 patients per group would provide 80% power for detecting a difference in means of 0.6 degrees Celsius, with a pooled SD of 0.67 degrees, using a two group t test and a two sided alpha level of 0.05. A previous RCT of IV acetaminophen in healthy male volunteers with induced fever found a core temperature difference of 0.60 degrees with a common SD of 0.67 degrees Celsius.|
1642415|NCT01869634|3019346|Other|||||||0.807|||||||Sign test|||Changes in systemic immune activation through IL6|
1642416|NCT01869634|3019346|Other|Two-sample Wilcoxon rank-sum (Mann-Whitney) test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||comparison between groups (HIV+ vs HIV-)|
1642417|NCT01869634|3019347|Other|Wilcoxon signed-rank test||||||0.826|||||||Sign test|||Comparison of coronary artery wall thickness before and after ART in the HIV infected participants.|
1642418|NCT01869634|3019347|Other|Two-sample Wilcoxon rank-sum (Mann-Whitney) test||||||0.032|||||||Wilcoxon (Mann-Whitney)||||
1642419|NCT01869634|3019348|Other|Wilcoxon signed-rank test. Paired samples.||||||0.0025|||||||Sign test|||Comparison between HIV positive naïve to ART before and after ART has been done.|
1642420|NCT01868997|3019364|Superiority||Difference in Least Squares Mean|6.32|Standard Error of the Mean|3.81||0.101|2-Sided|95.0|-1.255|13.901|||Mixed-Model Repeated Measures||||
1642421|NCT01868997|3019365|Superiority||Difference in Least Squares Mean|14.16|Standard Error of the Mean|3.827|<|0.001|2-Sided|95.0|6.549|21.773|||Mixed-Model Repeated Measures||||
1642422|NCT01868997|3019366|Superiority||Difference in Least Squares Mean|-1.59|Standard Error of the Mean|0.245|<|0.001|2-Sided|95.0|-2.073|-1.098|||Mixed-Model Repeated Measures||||
1642423|NCT01868997|3019367|Superiority||Difference in Least Squares Mean|-2.31|Standard Error of the Mean|0.269|<|0.001|2-Sided|95.0|-2.843|-1.772|||Mixed-Model Repeated Measures||||
1642424|NCT01868997|3019368|Superiority||Difference in Least Squares Mean|10.97|Standard Error of the Mean|3.221||0.001|2-Sided|95.0|4.561|17.375|||Mixed-Model Repeated Measures||||
1642425|NCT01868997|3019369|Superiority||Odds Ratio (OR)|8.86|||<|0.001|2-Sided|95.0|3.293|23.825||Odds ratio, 95% confidence interval, and P-value are obtained from a logistic regression model with treatment and smoking status as covariates.|Regression, Logistic||||
1642426|NCT01868646|3019377|Superiority|||||||0.7417|||||||t-test, 2 sided|||Hypoglycemia|
1642427|NCT01868646|3019377|Superiority|||||||0.5262|||||||t-test, 2 sided|||Hyperglycemia|
1642428|NCT01868646|3019377|Superiority|||||||0.1577|||||||t-test, 2 sided|||Satisfaction|
1642429|NCT01868646|3019378|Superiority|||||||0.341|||||||t-test, 2 sided||||
1642430|NCT01868646|3019379|Superiority|||||||0.2934|||||||t-test, 2 sided||||
1642431|NCT01868646|3019380|Superiority|||||||0.3108|||||||Fisher Exact||||
1642432|NCT01868646|3019381|Superiority|||||||0.0726|||||||t-test, 2 sided||||
1642433|NCT01868646|3019382|Superiority|||||||0.0605|||||||t-test, 2 sided||||
1642434|NCT01868646|3019383|Superiority|||||||0.3609||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis|||Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.|
1642435|NCT01868646|3019383|Superiority|||||||0.4195||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis|||Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.|
1642436|NCT01868646|3019383|Superiority|||||||0.7507||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis|||Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.|
1642437|NCT01868646|3019383|Superiority|||||||0.6155||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis|||Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.|
1642438|NCT01868646|3019384|Superiority|||||||0.6215||||||"The p-value associated with treatment factor of mean value at baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis||||
1642439|NCT01868646|3019385|Superiority|||||||0.599||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis||||
1642440|NCT01868646|3019386|Superiority|||||||0.0426||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis||||
1642441|NCT01868646|3019387|Superiority|||||||0.0002||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis||||
1642442|NCT01868633|3019392|Superiority or Other|||||||0.32|||||||Wilcoxon (Mann-Whitney)||||
1642443|NCT01868594|3019393|Superiority|||||||0.3714||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||"Analysis of Perceived Hypoglycemia question at Week 36 endpoint between Subetta and Placebo treatment groups."|
1642444|NCT01868594|3019393|Superiority|||||||0.761||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||"Analysis of Perceived Hyperglycaemia question at Week 36 endpoint between Subetta and Placebo treatment groups."|
1642445|NCT01868594|3019393|Superiority|||||||0.2484||||||The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of total Treatment Satisfaction score at Week 36 endpoint between Subetta and Placebo treatment groups.|
1642447|NCT01868594|3019395|Superiority|||||||0.3847||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of total daily dose insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|
1642448|NCT01868594|3019395|Superiority|||||||0.5236||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of prandial insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|
1642449|NCT01868594|3019395|Superiority|||||||0.3107||||||The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|t-test, 2 sided|||Analysis of basal insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.|
1642450|NCT01868594|3019396|Superiority|||||||0.0764||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis|||Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.|
1642451|NCT01868594|3019396|Superiority|||||||0.1619||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis|||Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.|
1642452|NCT01868594|3019396|Superiority|||||||0.8114||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis|||Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.|
1642453|NCT01868594|3019396|Superiority|||||||0.278||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis|||Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.|
1642454|NCT01868594|3019397|Superiority|||||||0.7344||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis||||
1642455|NCT01868594|3019398|Superiority|||||||0.0432||||||"The p-value associated with treatment factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis||||
1642456|NCT01868594|3019399|Superiority|||||||0.019||||||"The p-value associated with treatment factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction."|Mixed Models Analysis||||
1642457|NCT01868477|3019424|Other|difference|Mean Difference (Final Values)|14.4|||||2-Sided|95.0|-24.0|48.16|||||||
1642458|NCT01868334|3019438|Superiority or Other|||||||0.05||||||Cochran-Armitage trend tests for difference between pre and post changes in vaccination rates for Pre-Post study period|Cochran-Armitage trend test||||
1642459|NCT01868334|3019438|Superiority or Other|||||||0.05|||||||Chi-squared|Chi-square tests for comparisons between-arm changes in vaccination rates between pre and post intervention for Pre-post study period|||
1642460|NCT01868334|3019439|Superiority or Other|||||||0.05||||||Cochran-Armitage trend tests for percentage point difference between Baseline and Year 1 for RCCT study period|Cochran-Armitage trend test||||
1642461|NCT01868334|3019439|Superiority or Other|||||||0.05|||||||Chi-squared|Chi-square tests for comparisons between-arm changes in vaccination rates between Baseline and Year 1 for RCCT study period|||
1642462|NCT01868165|3019442|Other||Slope|0.58|||||2-Sided|95.0|-0.6|1.77|||||"Linear regression slope and 95% confidence intervals for the association between calcium channel blocker use and cognitive change was 0.58 (-0.60:1.77).~Multiple adjustments including; age, sex, education."||
1642463|NCT01868009|3019491|Superiority or Other||||||<|0.001||||||The response was analyzed and adjusted for study inhaler use sequence and preference question version. The method accounted for participants who indicated no preference.|Cochran-Mantel-Haenszel||||
1642464|NCT01867671|3019508|Superiority||Mean Difference (Final Values)|1464.0|||<|0.0001|2-Sided|95.0|944.0|1985.0|||Chi-squared||||
1642465|NCT01867671|3019509|Other|McNemar’s Test|Simple Kappa Coefficient|0.162|||<|0.0001|2-Sided|95.0|0.0628|0.2612|||McNemar||||
1642466|NCT01867671|3019510|Superiority||Odds Ratio (OR)|27.82|||<|0.0031|2-Sided|95.0|3.07|252.33|||Regression, Logistic||||
1642467|NCT01867671|3019511|Superiority||Odds Ratio (OR)|205.45|||<|0.0001|2-Sided|95.0|24.0|1758.51|||Regression, Logistic||||
1642468|NCT01867606|3019523|Superiority|||||||0.62|||||||Chi-squared||||
1642469|NCT01867606|3019525|Superiority|||||||0.29|||||||Fisher Exact||||
1642470|NCT01867580|3019528|Superiority|||||||0.0142|||||||Regression, Logistic||||
1642471|NCT01867580|3019529|Superiority|||||||0.0202|||||||Wilcoxon (Mann-Whitney)||||
1642472|NCT01867580|3019530|Superiority|||||||0.677|||||||Regression, Logistic||||
1642473|NCT01867307|3019536|Superiority or Other||Median Difference (Final Values)|-234.0|Standard Error of the Mean|25.8|<|0.0001|2-Sided|95.0|-312.3|-201.5||P−value is from a paired t−test|Paired t-test||Difference calculated as (Day 14 - baseline) values|Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.|
1642474|NCT01867307|3019536|Superiority or Other||Median Difference (Final Values)|-220.0|Standard Error of the Mean|55.5|<|0.0001|2-Sided|95.0|-440.6|-202.7||P−value is from a paired t−test.|Paired t- test||Difference calculated as (Day 14 - baseline) values|Point estimates of the changes from baseline and 95% Confidence interval around the estimates on treatment day 14 were computed.|
1642475|NCT01867047|3019562|Superiority|||||||0.702|||||||t-test, 2 sided||||
1642476|NCT01867047|3019563|Superiority|||||||0.7|||||||t-test, 2 sided||||
1642528|NCT01865448|3019700|Superiority or Other|||||||0.72828|||||||Fisher Exact|||Between-Group Comparison|
1642477|NCT01867047|3019566|Superiority|||||||0.102|||||||t-test, 2 sided|||Analysis for number of participants given vasopressors intraoperatively|
1642478|NCT01867047|3019568|Superiority|||||||1|||||||t-test, 2 sided|||Statistical analysis for postoperative mild hypotension|
1642479|NCT01867047|3019568|Superiority|||||||0.14|||||||t-test, 2 sided|||Statistical analysis for intraoperative mild hypotension|
1642480|NCT01867021|3019572|Non-Inferiority or Equivalence|Percentage of subjects with HI seroconversion of TIV vaccine for strain B considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf – Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|-1.0|||||2-Sided|95.0|-5.0|2.3||||||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain B at day 22|
1642481|NCT01867021|3019572|Non-Inferiority or Equivalence|Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H3N2 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf – Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|13.0|||||2-Sided|95.0|10.1|16.1||||||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H3N2 at day 22|
1642482|NCT01867021|3019572|Non-Inferiority or Equivalence|Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H1N1 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf – Seroconversion TIV) was ≤10%.|Difference in seroconversion rates|9.0|||||2-Sided|95.0|5.6|11.5||||||Non-inferiority of percentage of subjects with HI seroconversion of TIV vaccine over TIVf vaccine for the strain A/H1N1 at day 22|
1642483|NCT01867021|3019573|Non-Inferiority or Equivalence|The HI GMTs of TIV vaccine for strain B considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.0|||||2-Sided|95.0|0.93|1.08||||||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain B at day 22|
1642484|NCT01867021|3019573|Non-Inferiority or Equivalence|The HI GMTs of TIV vaccine for strain A/H3N2 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.5|||||2-Sided|95.0|1.38|1.64||||||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H3N2 at day 22|
1642485|NCT01867021|3019573|Non-Inferiority or Equivalence|The HI GMTs of TIV vaccine for strain A/H1N1 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5|Ratio of GMTs|1.85|||||2-Sided|95.0|1.66|2.06||||||Non-inferiority of HI GMTs of TIV vaccine over HI GMTs of TIVf vaccine for the strain A/H1N1 at day 22|
1642486|NCT01866826|3019593|Superiority|||||||0.54|||||||Wilcoxon|||We calculated the percentage of total lymphocytes that were expressing the activation markers at each time point, and compared the differences in the percentages in the Rifaximin and control groups. We used the T-test to detect differences between the differences in percentages in the control group and Rifaximin groups.|
1642487|NCT01866826|3019593|Superiority||Mean Difference (Net)|0.7872|||||2-Sided|||||||||We calculated the percentage of total lymphocytes that were expressing activation markers at each time point, and compared the differences in the percentages in the Rifaximin and control groups. We used the Wilcoxon test to detect differences between the differences in percentages in the control and Rifaximin groups.|
1642488|NCT01866826|3019595|Superiority|||||||||||||||||We calculated the proportion of pts with elevated viral levels >50 copies/ml at each phase of the study.|We estimated that four of the seven patients would have an elevation in viral Ribonucleic Acid (RNA) level >50 copies/ml.
1642489|NCT01866826|3019596|Superiority|||||||0.51|||||||Wilcoxon (Mann-Whitney)||||
1642490|NCT01866410|3019638|Other|||||||0.5|||||||Log Rank||||
1642491|NCT01866410|3019639|Other|||||||0.4|||||||Log Rank||||
1642492|NCT01866319|3019646|Superiority or Other (legacy)||Percent difference|-1.1||||0.82636||95.0|-10.6|8.6|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)|
1642493|NCT01866319|3019646|Superiority or Other (legacy)||Percent difference|17.2||||2e-05|2-Sided|95.0|9.5|25.6|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)|
1642494|NCT01866319|3019646|Superiority or Other (legacy)||Percent difference|16.1||||0.00013|2-Sided|95.0|7.8|24.5|||Miettinen & Nurmimen|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)|
1642495|NCT01866319|3019647|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.51319||95.0|0.67|1.22|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).|
1642496|NCT01866319|3019647|Superiority or Other (legacy)||Hazard Ratio (HR)|0.69||||0.00358|2-Sided|95.0|0.52|0.9|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).|
1642497|NCT01866319|3019647|Superiority or Other (legacy)||Hazard Ratio (HR)|0.63||||0.00052|2-Sided|95.0|0.47|0.83|||Regression, Cox|||Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).|
1642498|NCT01866319|3019648|Superiority or Other (legacy)||Hazard Ratio (HR)|0.97||||0.75869|2-Sided|95.0|0.77|1.21|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)|
1642499|NCT01866319|3019648|Superiority or Other (legacy)||Hazard Ratio (HR)|0.58|||<|1e-05|2-Sided|95.0|0.47|0.72|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)|
1642529|NCT01865448|3019701|Superiority or Other|||||||0.4563|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642500|NCT01866319|3019648|Superiority or Other (legacy)||Hazard Ratio (HR)|0.58|||<|1e-05|2-Sided|95.0|0.46|0.72|||Log Rank|||Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)|
1642501|NCT01866163|3019663|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.27|||<|0.001|2-Sided|95.0|-1.76|-0.78|||ANOVA|||The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.|
1642502|NCT01866163|3019664|Superiority or Other (legacy)||Mean Difference (Final Values)|-3.28|||<|0.001|2-Sided|95.0|-3.9|-2.67|||ANOVA|||The mean value and CIs were adjusted for the effect of pooled centres and baseline m-PASI. Multiple imputation was used to handle missing data.|
1642503|NCT01866163|3019665|Superiority or Other (legacy)||Odds Ratio (OR)|30.27|||<|0.001|2-Sided|95.0|9.72|94.3|||Mantel Haenszel|||Multiple imputations were used to handle missing data.|
1642504|NCT01866150|3019669|Superiority or Other||Mean Difference (Final Values)|-8.81||||0.0237|2-Sided|95.0|-16.44|-1.18|||General Linear Model|||Analysis was performed using a general linear model with cohort as a factor.|
1642505|NCT01866150|3019671|Superiority or Other||Treatment difference|-0.15|Standard Error of the Mean|0.154||0.3264|2-Sided|95.0|-0.45|0.15|||Mixed Models Analysis|||Comparison at the last visit. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.|
1642506|NCT01866150|3019671|Superiority or Other||Treatment difference|-0.17|Standard Error of the Mean|0.149||0.242|2-Sided|95.0|-0.47|0.12|||Mixed Models Analysis|||Comparison at Month 6. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.|
1642507|NCT01866150|3019671|Superiority or Other||Treatment Difference|-0.1|Standard Error of the Mean|0.152||0.5195|2-Sided|95.0|-0.4|0.2|||Mixed Models Analysis|||Comparison at Month 3. Analysis used a mixed model with month, cohort, baseline DAS28 score; cohort-by-month and cohort-by-baseline DAS28 score as fixed effects. Within-participant repeated measurements were incorporated with an unstructured variance-covariance structure.|
1642508|NCT01866150|3019672|Superiority or Other||Treatment Difference|9.9||||0.0556|2-Sided|95.0|-0.3|20.2|||Pearson’s chi-squared|||Comparison at the last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.|
1642509|NCT01866150|3019672|Superiority or Other||Treatment Difference|3.4||||0.5649|2-Sided|95.0|-8.2|15.0|||Pearson’s chi-squared|||Comparison at Month 6. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.|
1642510|NCT01866150|3019672|Superiority or Other||Slope|-0.9||||0.8769|2-Sided|95.0|-12.1|10.4|||Pearson’s chi-squared|||Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved LDA.|
1642511|NCT01866150|3019673|Superiority or Other||Treatment Difference|2.6||||0.6349|2-Sided|95.0|-8.0|13.1|||Pearson’s chi-squared|||Comparison at last visit. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.|
1642512|NCT01866150|3019673|Superiority or Other||Treatment Difference|3.7||||0.4727|2-Sided|95.0|-6.2|13.6|||Pearson’s chi-squared|||Comparison at Month 3. A two-sided Pearson's chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.|
1642513|NCT01866150|3019674|Superiority or Other||Treatment Difference|1.2||||0.8222|2-Sided|95.0|-9.5|12.0|||Pearson’s chi-squared|||A two-sided Pearson’s chi-squared test was used to assess the treatment difference in the participants who achieved DAS28 remission.|
1642514|NCT01866098|3019675|Superiority|||||||0.43|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.|||
1642515|NCT01866098|3019676|Superiority|||||||0.95|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.|||
1642516|NCT01866098|3019677|Superiority|||||||0.98|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.|||
1642517|NCT01866098|3019678|Superiority|||||||0.92|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.|||
1642518|NCT01866098|3019679|Superiority|||||||0.96|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.|||
1642519|NCT01866098|3019680|Superiority|||||||0.19|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.|||
1642520|NCT01866098|3019681|Superiority|||||||0.1|||||||Chi-squared||||
1642521|NCT01866098|3019682|Superiority|||||||0.83|||||||Mixed Models Analysis|Estimated treatment differences between groups analyzed using mixed-model analysis. Model includes the baseline value age; sex; compliance; ethnicity.|||
1642522|NCT01865812|3019683|Superiority or Other||Mean Difference (Net)|-0.06|||||2-Sided|95.0|-1.58|1.46|||||||
1642523|NCT01865812|3019684|Superiority or Other||Mean Difference (Net)|-0.44|||||2-Sided|95.0|-0.63|-0.25|||||||
1642524|NCT01865812|3019685|Superiority or Other||Mean Difference (Net)|-0.38|||||2-Sided|95.0|-0.51|-0.24|||||||
1642525|NCT01865747|3019686|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1642526|NCT01865747|3019687|Superiority||Hazard Ratio (HR)|0.66||||0.0003|2-Sided|95.0|0.53|0.83|||Log Rank|The Log-Rank test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group and number of prior VEGFR TKIs.|||
1642527|NCT01865747|3019688|Superiority||Hazard Ratio (HR)|0.58|||<|0.0001|2-Sided|95.0|0.45|0.74|||Log Rank|The Log-Rank Test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) group and number of prior VEGFR TKIs.|||
1642530|NCT01865448|3019701|Superiority or Other|||||||0.022|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642531|NCT01865448|3019701|Superiority or Other|||||||0.032|||||||ANCOVA|||Between-Group Comparison|
1642532|NCT01865448|3019702|Superiority or Other|||||||0.5669|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642533|NCT01865448|3019702|Superiority or Other|||||||0.768|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642534|NCT01865448|3019702|Superiority or Other|||||||0.7964|||||||ANCOVA|||Between-Group Comparison|
1642535|NCT01865448|3019703|Superiority or Other|||||||0.9188|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642536|NCT01865448|3019703|Superiority or Other|||||||0.2337|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642537|NCT01865448|3019703|Superiority or Other|||||||0.1946|||||||ANCOVA|||Between-Group Comparison|
1642538|NCT01865448|3019704|Superiority or Other|||||||0.0062|||||||Paired t-test||||
1642539|NCT01865448|3019704|Superiority or Other|||||||0.0049|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642540|NCT01865448|3019704|Superiority or Other|||||||0.985|||||||ANCOVA|||Between-Group Comparison|
1642541|NCT01865448|3019705|Superiority or Other||||||<|0.0001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642542|NCT01865448|3019705|Superiority or Other||||||<|0.0001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642543|NCT01865448|3019705|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Between-Group Comparison|
1642544|NCT01865448|3019706|Superiority or Other|||||||0.0066|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642545|NCT01865448|3019706|Superiority or Other|||||||0.0431|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642546|NCT01865448|3019706|Superiority or Other|||||||0.5893|||||||ANCOVA|||Between-Group Comparison|
1642547|NCT01865448|3019707|Superiority or Other||||||<|0.0001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642548|NCT01865448|3019707|Superiority or Other||||||<|0.0001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642549|NCT01865448|3019707|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Between-Group Comparison|
1642550|NCT01865448|3019708|Superiority or Other|||||||0.1811|||||||Paired t-test||||
1642551|NCT01865448|3019708|Superiority or Other|||||||0.3774|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642552|NCT01865448|3019708|Superiority or Other|||||||0.141|||||||ANCOVA|||Between-Group Comparison|
1642553|NCT01865448|3019709|Superiority or Other|||||||0.1342|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642554|NCT01865448|3019709|Superiority or Other|||||||0.0761|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642555|NCT01865448|3019709|Superiority or Other|||||||0.2643|||||||ANCOVA|||Between-Group Comparison|
1642556|NCT01865448|3019710|Superiority or Other|||||||0.3811|||||||Paired t-test||||
1642557|NCT01865448|3019710|Superiority or Other|||||||0.145|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642558|NCT01865448|3019710|Superiority or Other|||||||0.9662|||||||ANCOVA|||Between-Group Comparison|
1642559|NCT01865448|3019711|Superiority or Other|||||||0.3526|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642560|NCT01865448|3019711|Superiority or Other|||||||0.098|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642561|NCT01865448|3019711|Superiority or Other|||||||0.6896|||||||ANCOVA|||Between-Group Comparison|
1642562|NCT01865448|3019712|Superiority or Other|||||||0.6484|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642563|NCT01865448|3019712|Superiority or Other|||||||0.1263|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642564|NCT01865448|3019712|Superiority or Other|||||||0.0783|||||||ANCOVA|||Between-Group Comparison|
1642565|NCT01865448|3019713|Superiority or Other|||||||0.0564|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642566|NCT01865448|3019713|Superiority or Other|||||||0.5184|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642567|NCT01865448|3019713|Superiority or Other|||||||0.2999|||||||ANCOVA|||Between-Group Comparison|
1642568|NCT01865448|3019714|Superiority or Other|||||||0.0011|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642569|NCT01865448|3019714|Superiority or Other|||||||0.192|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642570|NCT01865448|3019714|Superiority or Other|||||||0.0528|||||||ANCOVA|||Between-Group Comparison|
1642571|NCT01865448|3019715|Superiority or Other|||||||0.2532|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642572|NCT01865448|3019715|Superiority or Other|||||||0.5594|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642573|NCT01865448|3019715|Superiority or Other|||||||0.2914|||||||ANCOVA|||Between-Group Comparison|
1642574|NCT01865448|3019716|Superiority or Other|||||||0.0237|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642575|NCT01865448|3019716|Superiority or Other|||||||0.5114|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642576|NCT01865448|3019716|Superiority or Other|||||||0.8765|||||||ANCOVA|||Between-Group Comparison|
1642577|NCT01865448|3019717|Superiority or Other|||||||0.4536|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642578|NCT01865448|3019717|Superiority or Other|||||||0.7218|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642579|NCT01865448|3019717|Superiority or Other|||||||0.8969|||||||ANCOVA|||Between-Group Comparison|
1642630|NCT01865448|3019734|Superiority or Other||||||<|0.58561|||||||ANCOVA|||Between-Group Comparison|
1642580|NCT01865448|3019718|Superiority or Other|||||||0.0197|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642581|NCT01865448|3019718|Superiority or Other|||||||0.0472|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642582|NCT01865448|3019718|Superiority or Other|||||||0.1226|||||||ANCOVA|||Between-Group Comparison|
1642583|NCT01865448|3019719|Superiority or Other|||||||0.0402|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642584|NCT01865448|3019719|Superiority or Other|||||||0.0291|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642585|NCT01865448|3019719|Superiority or Other|||||||0.3694|||||||ANCOVA|||Between-Group Comparison|
1642586|NCT01865448|3019720|Superiority or Other|||||||0.0068|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642587|NCT01865448|3019720|Superiority or Other|||||||0.8625|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642588|NCT01865448|3019720|Superiority or Other|||||||0.683|||||||ANCOVA|||Between-Group Comparison|
1642589|NCT01865448|3019721|Superiority or Other|||||||0.3356|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642590|NCT01865448|3019721|Superiority or Other|||||||0.4292|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642591|NCT01865448|3019721|Superiority or Other|||||||0.2333|||||||ANCOVA|||Between-Group Comparison|
1642592|NCT01865448|3019722|Superiority or Other|||||||0.0073|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642593|NCT01865448|3019722|Superiority or Other|||||||0.1365|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642594|NCT01865448|3019722|Superiority or Other|||||||0.345|||||||ANCOVA|||Between-Group Comparison|
1642595|NCT01865448|3019723|Superiority or Other|||||||0.0823|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642596|NCT01865448|3019723|Superiority or Other|||||||0.2128|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642597|NCT01865448|3019723|Superiority or Other|||||||0.2894|||||||ANCOVA|||Between-Group Comparison|
1642598|NCT01865448|3019724|Superiority or Other|||||||0.5827|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642599|NCT01865448|3019724|Superiority or Other|||||||0.714|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642600|NCT01865448|3019724|Superiority or Other|||||||0.5932|||||||ANCOVA|||Between-Group Comparison|
1642601|NCT01865448|3019725|Superiority or Other|||||||0.6014|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642602|NCT01865448|3019725|Superiority or Other|||||||0.4749|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642603|NCT01865448|3019725|Superiority or Other|||||||0.7047|||||||ANCOVA|||Between-Group Comparison|
1642604|NCT01865448|3019726|Superiority or Other|||||||0.9898|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642605|NCT01865448|3019726|Superiority or Other|||||||0.1034|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642606|NCT01865448|3019726|Superiority or Other|||||||0.2792|||||||ANCOVA|||Between-Group Comparison|
1642607|NCT01865448|3019727|Superiority or Other|||||||0.3198|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642608|NCT01865448|3019727|Superiority or Other|||||||0.4421|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642609|NCT01865448|3019727|Superiority or Other|||||||0.2813|||||||ANCOVA|||Between-Group Comparison|
1642610|NCT01865448|3019728|Superiority or Other|||||||0.0394|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642611|NCT01865448|3019728|Superiority or Other|||||||0.0482|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642612|NCT01865448|3019728|Superiority or Other|||||||0.3187|||||||ANCOVA|||Between-Group Comparison|
1642613|NCT01865448|3019729|Superiority or Other|||||||0.0474|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642614|NCT01865448|3019729|Superiority or Other|||||||0.0404|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642615|NCT01865448|3019729|Superiority or Other|||||||0.8591|||||||ANCOVA|||Between-Group Comparison|
1642616|NCT01865448|3019730|Superiority or Other|||||||0.0281|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642617|NCT01865448|3019730|Superiority or Other|||||||0.3761|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642618|NCT01865448|3019730|Superiority or Other|||||||0.6779|||||||ANCOVA|||Between-Group Comparison|
1642619|NCT01865448|3019731|Superiority or Other|||||||0.8226|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642620|NCT01865448|3019731|Superiority or Other|||||||0.2755|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642621|NCT01865448|3019731|Superiority or Other|||||||0.247|||||||ANCOVA|||Between-Group Comparison|
1642622|NCT01865448|3019732|Superiority or Other|||||||0.0049|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642623|NCT01865448|3019732|Superiority or Other|||||||0.431|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642624|NCT01865448|3019732|Superiority or Other|||||||0.6664|||||||ANCOVA|||Between-Group Comparison|
1642625|NCT01865448|3019733|Superiority or Other|||||||0.0795|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642626|NCT01865448|3019733|Superiority or Other|||||||0.0351|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642627|NCT01865448|3019733|Superiority or Other|||||||0.1953|||||||ANCOVA|||Between-Group Comparison|
1642628|NCT01865448|3019734|Superiority or Other||||||<|0.001|||||||Paired t-test||||
1642629|NCT01865448|3019734|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642631|NCT01865448|3019735|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642632|NCT01865448|3019735|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642633|NCT01865448|3019735|Superiority or Other||||||<|0.28743|||||||ANCOVA|||Between-Group Comparison|
1642634|NCT01865448|3019736|Superiority or Other||||||<|0.05|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642635|NCT01865448|3019736|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642636|NCT01865448|3019736|Superiority or Other||||||<|0.66053|||||||ANCOVA|||Between-Group Comparison|
1642637|NCT01865448|3019737|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642638|NCT01865448|3019737|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642639|NCT01865448|3019737|Superiority or Other||||||<|0.60214|||||||ANCOVA|||Between-Group Comparison|
1642640|NCT01865448|3019738|Superiority or Other|||||||0.05726|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642641|NCT01865448|3019738|Superiority or Other|||||||0.05726|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642642|NCT01865448|3019738|Superiority or Other|||||||0.13911|||||||ANCOVA|||Between-Group Comparison|
1642643|NCT01865448|3019739|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642644|NCT01865448|3019739|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642645|NCT01865448|3019739|Superiority or Other||||||<|0.40485|||||||ANCOVA|||Between-Group Comparison|
1642646|NCT01865448|3019740|Superiority or Other|||||||0.18876|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642647|NCT01865448|3019740|Superiority or Other|||||||0.18876|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642648|NCT01865448|3019740|Superiority or Other|||||||0.76435|||||||ANCOVA|||Between-Group Comparison|
1642649|NCT01865448|3019741|Superiority or Other|||||||0.25908|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642650|NCT01865448|3019741|Superiority or Other|||||||0.25908|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642651|NCT01865448|3019741|Superiority or Other|||||||0.82322|||||||ANCOVA|||Between-Group Comparison|
1642652|NCT01865448|3019742|Superiority or Other|||||||0.00162|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642653|NCT01865448|3019742|Superiority or Other|||||||0.00162|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642654|NCT01865448|3019742|Superiority or Other|||||||0.24396|||||||ANCOVA|||Between-Group Comparison|
1642655|NCT01865448|3019743|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642656|NCT01865448|3019743|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642657|NCT01865448|3019743|Superiority or Other||||||<|0.04491|||||||ANCOVA|||Between-Group Comparison|
1642658|NCT01865448|3019744|Superiority or Other||||||<|0.001|||||||Paired t-test||||
1642659|NCT01865448|3019744|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642660|NCT01865448|3019744|Superiority or Other||||||<|0.28489|||||||ANCOVA|||Between-Group Comparison|
1642661|NCT01865448|3019745|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642662|NCT01865448|3019745|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 2 month data|
1642663|NCT01865448|3019745|Superiority or Other||||||<|0.27444|||||||ANCOVA|||Between-Group Comparison|
1642664|NCT01865448|3019746|Superiority or Other|||||||0.0476|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642665|NCT01865448|3019746|Superiority or Other|||||||0.3745|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642666|NCT01865448|3019746|Superiority or Other|||||||0.7474|||||||ANCOVA|||Between-Group Comparison|
1642667|NCT01865448|3019747|Superiority or Other|||||||0.0657|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642668|NCT01865448|3019747|Superiority or Other|||||||0.5257|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642669|NCT01865448|3019747|Superiority or Other|||||||0.9573|||||||ANCOVA|||Between-Group Comparison|
1642670|NCT01865448|3019748|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642671|NCT01865448|3019748|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642672|NCT01865448|3019748|Superiority or Other||||||<|0.24567|||||||ANCOVA|||Between-Group Comparison|
1642673|NCT01865448|3019749|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642674|NCT01865448|3019749|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642675|NCT01865448|3019749|Superiority or Other||||||<|0.519|||||||ANCOVA|||Between-Group Comparison|
1642676|NCT01865448|3019750|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Within-group comparisons between the baseline and 6 month data|
1642677|NCT01865448|3019750|Superiority or Other||||||<|0.001|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642678|NCT01865448|3019750|Superiority or Other||||||<|0.71833|||||||ANCOVA|||Between-Group Comparison|
1642679|NCT01865448|3019751|Superiority or Other|||||||0.4533|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1643020|NCT01855997|3020491|Superiority or Other|||||||6.86e-06|||||||t-test, 2 sided|||rs6443144|
1642680|NCT01865448|3019751|Superiority or Other|||||||0.8689|||||||Paired t-test|||Within-group comparisons between the baseline and 6 month data|
1642681|NCT01865448|3019751|Superiority or Other|||||||0.278|||||||ANCOVA|||Between-Group Comparison|
1642682|NCT01865084|3019758|Superiority or Other (legacy)|||||||0.538||||||The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.|Mixed Models Analysis||||
1642683|NCT01865084|3019758|Superiority or Other (legacy)|||||||0.307||||||The p-value is based on the treatment difference LS Mean changes from baseline between tadalafil and placebo.|Mixed Models Analysis||||
1642684|NCT01864525|3019760|Superiority|||||||0.7172||||||A priori significance was set at P<0.05 for this hypothesis-driven auditory-perceptual variable. Main effect for drug is given above. For the main task effect, P=0.9602. For the interaction effect of drug*task, P=0.1699.|Mixed Models Analysis|||Statistical modeling tested for main effects of auditory-perceptual ratings for drug and task (sustained vowel and sentence-level ratings), and interaction effects of these variables. The summed scores, averaged across all participants, are provided separately for the sustained vowel and sentence-level ratings. Values range from 0 (no difference between baseline and post-test) to 3 (all three raters indicated that post-test sample was better (less tremor severity).|
1642685|NCT01864525|3019761|Superiority|||||||0.045||||||Statistical results for Magnitude of acoustic frequency tremor. A priori significance threshold was set at P<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test used the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein & Rosenfeld, 1985).|
1642686|NCT01864525|3019761|Superiority|||||||0.0339||||||Statistical results for Magnitude of acoustic frequency tremor. A priori significance threshold was set at P<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test did not use the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein & Rosenfeld, 1985).|
1642687|NCT01864525|3019761|Superiority|||||||0.0499||||||Statistical results for Magnitude of acoustic amplitude tremor. A priori significance threshold was set at P<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test used the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein & Rosenfeld, 1985).|
1642688|NCT01864525|3019761|Superiority|||||||0.0216||||||Statistical results for Magnitude of acoustic amplitude tremor. A priori significance threshold was set at P<0.05 for each of the two hypothesis-driven acoustic variables.|Mixed Models Analysis|This statistical test did not use the baseline scores as a covariate when comparing post-test scores between placebo and octanoic acid conditions.||Separate measures for magnitude of amplitude tremor and magnitude of frequency tremor were analyzed as these variables can respond differently to treatment and may be differentially affected in essential voice tremor. Statistical modeling tested for post-treatment drug differences, with testing session as a repeated factor. Models were run with and without inclusion of baseline averages as a covariate per recommendations for cross-over treatment studies (Fleiss, Wallenstein & Rosenfeld, 1985).|
1642689|NCT01864174|3019773|Non-Inferiority or Equivalence (legacy)|The study provided 90% power to demonstrate noninferiority in change from baseline mean HbA1c at Week 24, with an assumed standard deviation (SD) of 1.0%, a non-inferiority margin of 0.3%, and 2-sided alpha of 0.05 for the primary comparison|Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.0687|||2-Sided|95.0|-0.1|0.17|||||METFORMIN XR VS METFORMIN IR||
1642690|NCT01864148|3019776|Superiority or Other|||||||0.5255|||||||Trend test|Trend test p-value is based on a linear contrast in logistic regression.|||
1642691|NCT01864148|3019776|Superiority or Other||Odds Ratio (OR)|0.86||||0.6578|2-Sided|95.0|0.45|1.65|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.|||
1642692|NCT01864148|3019776|Superiority or Other||Odds Ratio (OR)|1.42||||0.2766|2-Sided|95.0|0.76|2.65|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.|||
1642693|NCT01864148|3019776|Superiority or Other||Odds Ratio (OR)|1.53||||0.1873|2-Sided|95.0|0.81|2.89|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.|||
1642694|NCT01864148|3019776|Superiority or Other||Odds Ratio (OR)|0.65||||0.3058|2-Sided|95.0|0.28|1.49|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.|||
1642695|NCT01864148|3019777|Superiority or Other|||||||0.8931|||||||Trend test|Trend test p-value is based on a linear contrast in logistic regression.|||
1642696|NCT01864148|3019777|Superiority or Other||Odds Ratio (OR)|0.66||||0.1771|2-Sided|95.0|0.36|1.21|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.|||
1642697|NCT01864148|3019777|Superiority or Other||Odds Ratio (OR)|2.06||||0.022|2-Sided|95.0|1.11|3.84|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.|||
1642698|NCT01864148|3019777|Superiority or Other||Odds Ratio (OR)|1.79||||0.0636|2-Sided|95.0|0.97|3.31|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.|||
1642699|NCT01864148|3019777|Superiority or Other||Odds Ratio (OR)|0.98||||0.9584|2-Sided|95.0|0.46|2.07|||Regression, Logistic|Odds ratios, 95% CI and p-values are based on logistic regression adjusted for MS type, region and baseline component assessments.|||
1642700|NCT01864005|3019778|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1642701|NCT01864005|3019779|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1642702|NCT01864005|3019780|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1642703|NCT01864005|3019781|Superiority or Other|||||||0.0828|||||||Wilcoxon (Mann-Whitney)||||
1642704|NCT01864005|3019782|Superiority or Other||Mean Difference (Final Values)|38.421||||0.0003|2-Sided|95.0|18.559|58.283|||ANOVA||||
1642705|NCT01864005|3019782|Superiority or Other|||||||0.0021||||||not adjusted for multiple comparisons. statistical significance level: 0.05|Wilcoxon (Mann-Whitney)||||
1642706|NCT01863758|3019792|Superiority or Other||Annualized number of spontaneous BEs|1.9|||<|0.05|2-Sided|95.0|1.46|2.43|||2-sided, 1-sample Poisson test||The annualized number of spontaneous bleeding episodes in study GENA-01 was 32.23|This study was considered as showing efficacy if the annualized number of spontaneous bleeding episodes (BE) was reduced by 50% compared to the number of spontaneous BEs observed in study GENA-01 (NCT00989196).|
1642707|NCT01863758|3019793|Superiority or Other||Annualized number of bleeding episodes|3.13|||<|0.05|2-Sided|95.0|2.56|3.8|||2-sided, 1-sample Poisson test||The annualized number of bleeding episodes in study GENA-01 was 49.36.|This study was considered as showing efficacy if the annualized number of bleeding episodes (BE) was reduced by 50% compared to the number of BEs observed in study GENA-01 (NCT00989196).|
1642708|NCT01862874|3019838|Superiority||Vaccine Efficacy|86.5|||<|0.001|2-Sided|95.0|55.2|97.4|||One-sided exact test||Vaccine efficacy is defined as the percentage reduction in relative risk for the V501 versus the placebo group.||If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, superiority of the V501 group is demonstrated.
1642709|NCT01862874|3019839|Other|Statistical testing of no difference in incidence of vaccine-related systemic AEs|Risk Difference (RD)|-1.6|||||2-Sided|95.0|-4.1|0.8|||||Risk difference (V501 - placebo) was estimated using the Miettinen & Nurminen method.||
1642710|NCT01862874|3019840|Other|Statistical testing of no difference in incidence of systemic AEs|Risk Difference (RD)|-0.9|||||2-Sided|95.0|-5.2|3.3|||||Risk difference (V501 - placebo) was estimated using the Miettinen & Nurminen method.||
1642711|NCT01862874|3019841|Other|Statistical testing of no difference in incidence of injection-site swelling|Risk Difference (RD)|6.8||||0.003|2-Sided|95.0|2.3|11.3|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen & Nurminen method.|Injection-site swelling|
1642712|NCT01862874|3019841|Other|Statistical testing of no difference in incidence of injection-site pain|Risk Difference (RD)|6.4||||0.033|2-Sided|95.0|0.5|12.2|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen & Nurminen method.|Injection-site pain|
1642713|NCT01862874|3019841|Other|Statistical testing of no difference in incidence of injection-site erythema|Risk Difference (RD)|2.9||||0.251|2-Sided|95.0|-2.1|7.9|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen & Nurminen method.|Injection-site erythema|
1642714|NCT01862874|3019842|Other|Statistical testing of no difference in incidence of maximum temperature ≥37.5°C|Risk Difference (RD)|-1.2||||0.256|2-Sided|95.0|-3.5|0.9|||Miettinen & Nurminen||Risk difference (V501 - placebo) was estimated using the Miettinen & Nurminen method.||
1642715|NCT01862874|3019843|Superiority||Vaccine Efficacy|85.9|||<|0.001|2-Sided|95.0|52.7|97.3|||One-sided exact test||Vaccine efficacy is defined as the percentage reduction in relative risk for the V501 group versus the placebo group.||If the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%, then superiority of the V501 group is demonstrated.
1642716|NCT01861665|3019876|Superiority|||||||0.5||||||Pre incision vs. Post incision day 2.|t-test, 2 sided||||
1642717|NCT01861665|3019876|Superiority|||||||0.7263||||||Pre incision vs. Post incision post op day 1.|t-test, 2 sided||||
1642718|NCT01861665|3019876|Superiority|||||||0.8379||||||Pre Incision vs. Post Incision on Post op day 0.|t-test, 2 sided||||
1642719|NCT01861457|3019892|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1642720|NCT01861457|3019893|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1642721|NCT01860976|3019905|Superiority or Other||Estimate of difference|7.3||||0.137|2-Sided|95.0|-2.2|16.7|||Cochran-Mantel-Haenszel||Because the treatment difference for HAQ response rate was not significant at the 5% significance level, nominal p values are presented for endpoints lower in the testing hierarchy.||
1642722|NCT01860976|3019906|Superiority or Other||Estimate of difference|10.0||||0.034|2-Sided|95.0|1.0|19.1|||Cochran-Mantel-Haenszel||Because the treatment difference for HAQ response rate was not significant at the 5% significance level, nominal p values are presented for endpoints lower in the testing hierarchy.||
1642723|NCT01860976|3019907|Superiority or Other||Estimate of difference|14.0||||0.012|2-Sided|95.0|3.3|24.8|||Cochran-Mantel-Haenszel||Because the treatment difference for HAQ response rate was not significant at the 5% significance level, nominal p values are presented for endpoints lower in the testing hierarchy.||
1642724|NCT01860976|3019908|Superiority or Other||Estimate of difference|21.9||||0.003|2-Sided|95.0|8.3|35.6|||Cochran-Mantel-Haenszel||Because the treatment difference for HAQ response rate was not significant at the 5% significance level, nominal p values are presented for endpoints lower in the testing hierarchy.||
1642725|NCT01860976|3019909|Superiority or Other||Estimate of difference|7.2||||0.097|2-Sided|95.0|-1.1|15.6|||Cochran-Mantel-Haenszel||||
1642726|NCT01860976|3019910|Superiority or Other||Estimate of Difference|17.2|||<|0.001|2-Sided|95.0|8.7|25.6|||Cochran-Mantel-Haenszel||||
1642727|NCT01860846|3019916|Superiority or Other||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Social Function Scores: The null hypothesis was set as no difference.|
1643021|NCT01855997|3020492|Superiority or Other|||||||3.97e-06|||||||t-test, 2 sided|||rs17037122|
1642728|NCT01860846|3019916|Superiority or Other||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Emotional Function Scores: the null hypothesis was set as no difference.|
1642729|NCT01860846|3019916|Superiority or Other||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Systemic Symptoms Scores:The null hypothesis was set as no difference.|
1642730|NCT01860846|3019916|Superiority or Other||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Bowel-related Symptoms Scores: The null hypothesis was set as no difference.|
1642731|NCT01860846|3019917|Superiority or Other||||||=|0||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||General Health Scores: the null hypothesis was set as no difference.|
1642732|NCT01860846|3019917|Superiority or Other||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Bodily Pain Scores: the null hypothesis was set as no difference.|
1642733|NCT01860846|3019917|Superiority or Other||||||=|0||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Social Functioning Scores: the null hypothesis was set as no difference.|
1642734|NCT01860846|3019917|Superiority or Other||||||=|0||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Mental Health Scores: the null hypothesis was set as no difference.|
1642735|NCT01860846|3019917|Superiority or Other||||||=|0||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Vitality Scores: the null hypothesis was set as no difference.|
1642736|NCT01860846|3019917|Superiority or Other||||||=|0||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Role-Emotional Scores: the null hypothesis was set as no difference.|
1642737|NCT01860846|3019917|Superiority or Other||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Role-Physical Scores: the null hypothesis was set as no difference.|
1642738|NCT01860846|3019917|Superiority or Other||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||Physical Functioning Scores: the null hypothesis was set as no difference.|
1642739|NCT01860846|3019918|Superiority or Other||||||<|0.001||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.|
1642740|NCT01860846|3019919|Superiority or Other||||||=|0||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.|
1642741|NCT01860846|3019920|Superiority or Other||||||=|0||||||Baseline vs. 12 Months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.|
1642742|NCT01860846|3019921|Superiority or Other||||||=|0||||||Baseline vs. 12 months|Wilcoxon signed-ranked test|||The null hypothesis was set as no difference.|
1642743|NCT01860703|3019923|Superiority or Other||Median Difference (Final Values)|13.42|||||2-Sided|90.0|11.1|15.75|||||||
1642744|NCT01860703|3019926|Superiority or Other||Mean Difference (Final Values)|5.23|||||2-Sided|90.0|3.26|7.19|||||||
1642745|NCT01860703|3019932|Superiority or Other||Mean Difference (Final Values)|3.01|||||2-Sided|90.0|1.02|5.01|||||||
1642746|NCT01860651|3019942|Other||mean difference over time|-0.002||||0.22|2-Sided|95.0|-0.005|0.001|||Mixed Effect Model|||"Statistical analysis of Medical adherence in study Medication adm. at home were analysed using a Mixed Effect Model (MEM). The MEM model included a random patient effect and a fixed effect interaction between group and time, to evaluate difference between the groups over time."|
1642747|NCT01860521|3019957|Superiority or Other|||||||0.047|||||||Wilcoxon (Mann-Whitney)||||
1642748|NCT01860521|3019958|Superiority or Other|||||||0.047|||||||Wilcoxon (Mann-Whitney)||||
1642749|NCT01860521|3019959|Superiority or Other|||||||0.005|||||||Wilcoxon (Mann-Whitney)||||
1642750|NCT01860521|3019960|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1642751|NCT01860079|3019965|Superiority or Other||||||<|0.05|||||||Chi-squared, Corrected|||Categorical data were analyzed with χ2.Comparisons were also analyzed by χ2 between the early discharge and standard treatment arm for the primary outcomes.|
1642752|NCT01859988|3019980|Superiority or Other||LS mean difference|-26.8|Standard Error of the Mean|6.65|<|0.0001|2-Sided|95.0|-39.8|-13.7||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 100 mg q4w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1642753|NCT01859988|3019980|Superiority or Other||LS mean difference|-45.4|Standard Error of the Mean|6.66|<|0.0001|2-Sided|95.0|-58.5|-32.3||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q4w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1642754|NCT01859988|3019980|Superiority or Other||LS mean difference|-47.4|Standard Error of the Mean|6.76|<|0.0001|2-Sided|95.0|-60.6|-34.1||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 200 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1642755|NCT01859988|3019980|Superiority or Other||LS mean difference|-50.1|Standard Error of the Mean|6.67|<|0.0001|2-Sided|95.0|-63.3|-37.0||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg q2w vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1642756|NCT01859988|3019980|Superiority or Other||Least square (LS) mean difference|-55.7|Standard Error of the Mean|6.74|<|0.0001|2-Sided|95.0|-68.9|-42.4||Threshold for significance at 0.05 level.|ANCOVA||Dupilumab 300 mg qw vs Placebo|LS mean and standard error were obtained using analysis of covariance (ANCOVA) model with treatment and randomization strata (moderate vs severe;Japan vs rest of world) and relevant baseline values as covariates. Multiplicity was controlled using hierarchical testing procedure:highest dose vs. placebo was tested first. Comparison order was 300 mg qw,300 mg q2w,200 mg q2w,300 mg q4w & 100 mg q4w, vs placebo respectively. Testing continues only if previous comparison was statistically significant.|
1642757|NCT01859793|3019987|Superiority or Other||||||<|0.05|||||||ANOVA|||Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey’s test were applied if significant differences were detected|
1642758|NCT01859793|3019988|Superiority or Other||||||<|0.05|||||||ANOVA|||Outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey’s test were applied if significant differences were detected|
1642785|NCT01859312|3020055|Other|||||||0.009|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642759|NCT01859793|3019989|Superiority or Other||||||<|0.05|||||||ANOVA|||Primary and secondary outcome variables were compared across measurement periods by repeated measures ANOVA and post hoc analyses using Tukey’s test were applied if significant differences were detected. A priori sample size calculation demonstrated our study design has 80% power to detect a 1.5% absolute increase in FMD% with 30 subjects completing the entire study protocol at α=0.05.|
1642760|NCT01859390|3020016|Superiority|Difference in Proportions|Median Difference (Final Values)|-15.7||||0.19|2-Sided|95.0|-34.5|4.8|||Fisher Exact||||
1642761|NCT01859390|3020017|Superiority|Difference in Proportions|Mean Difference (Final Values)|-14.8||||0.2363|2-Sided|95.0|-35.1|7.4||Not adjusted for multiple comparisons. Alpha at 0.05.|Fisher Exact||||
1642762|NCT01859390|3020018|Superiority||Rate Ratio|0.72||||0.1731|2-Sided|95.0|0.44|1.16|||Poisson Model|||Rate Ratio for PEx calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months in the AquADEKs-2 group was 148 and in the Control group was 147.|
1642763|NCT01859390|3020019|Superiority||Cox Proportional Hazard|0.536||||0.0534|2-Sided|95.0|0.284|1.009||Not adjusted for multiple comparisons. Alpha at 0.05.|Regression, Cox||"Cox model parameters include: AquADEKs-2 arm, Age >=18 years, Sex, Screening FEV1 % Predicted >70%, Chronic use of Inhaled Antibiotics and Azithromycin.~The parameter of interest is the Hazard Ratio comparing the AquADEKs-2 arm to the control arm."||
1642764|NCT01859390|3020020|Superiority||Median Difference (Final Values)|0.04||||0.8623|2-Sided|95.0|-0.37|0.44|||t-test, 2 sided||||
1642765|NCT01859390|3020021|Superiority|Two sample T-test|Median Difference (Final Values)|1.43||||0.4463|2-Sided|95.0|-2.3|5.16|||t-test, 2 sided||||
1642766|NCT01859390|3020022|Superiority|Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.|Rate Ratio|0.74||||0.269|2-Sided|95.0|0.43|1.26|||Poisson Regression||||
1642767|NCT01859390|3020022|Superiority||Rate Ratio|0.94||||0.486|2-Sided|95.0|0.78|1.13|||Poisson Model|||Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.|
1642768|NCT01859390|3020023|Superiority||Difference in Proportions-SAE incidence|-12.9||||0.302|2-Sided|95.0|-32.1|7.8|||Fisher Exact||||
1642769|NCT01859390|3020024|Superiority||Mean Difference (Final Values)|-0.17||||0.325|2-Sided|95.0|-0.513|0.173|||Regression, Linear||"Regression Model predictors include: AquADEKs-2 arm, Age >=18 years, Sex, Screening FEV1%Predicted >70%, Chronic use of Inhaled Antibiotics and Azithromycin.~The estimated value is the mean difference between groups for 16 week change in log10 MPO."||
1642770|NCT01859390|3020024|Superiority||Mean Difference (Final Values)|-0.13||||0.46|2-Sided|95.0|-0.49|0.22|||t-test, 2 sided|||Two-sample T-test|
1642771|NCT01859325|3020025|Superiority||Median Difference (Final Values)|-0.36||||0.406|2-Sided|95.0|-1.41|0.67|||Wilcoxon (Mann-Whitney)|||Samples size based on published data on populations of early treated patients undergoing ART interruption. The power based on a 2-sample t-test with a 2-tailed alpha of .05 and a total sample size of 30 is approximately 91% to detect a 1.25 log10 reduction in the rebound plasma viremia between vaccine and placebo groups.|
1642772|NCT01859312|3020029|Other|||||||0.07|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642773|NCT01859312|3020031|Other|||||||0.103|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642774|NCT01859312|3020033|Other|||||||0.057|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642775|NCT01859312|3020035|Other|||||||0.084|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642776|NCT01859312|3020037|Other|||||||0.007|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|Comparison of hormone levels on conventional glucocorticoid therapy at baseline and following 6 months of CSHI.
1642777|NCT01859312|3020039|Other|||||||0.524|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642778|NCT01859312|3020041|Other|||||||0.004|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642779|NCT01859312|3020043|Other|||||||0.005|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642780|NCT01859312|3020045|Other|||||||0.031|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642781|NCT01859312|3020047|Other|||||||0.024|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642782|NCT01859312|3020049|Other|||||||0.043|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642783|NCT01859312|3020051|Other|||||||0.009|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642784|NCT01859312|3020053|Other|||||||0.008|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642886|NCT01856686|3020287|Superiority or Other|||||||0.39707|||||||ANCOVA|||Between-Group Comparison|
1642786|NCT01859312|3020057|Other|||||||0.015|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642787|NCT01859312|3020059|Other|||||||0.157|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642788|NCT01859312|3020061|Other|||||||0.012|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642789|NCT01859312|3020063|Other|||||||0.008|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642790|NCT01859312|3020065|Other|||||||0.027|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642791|NCT01859312|3020067|Other|||||||0.021|||||||t-test, 2 sided|||Comparisons of CSHI (at 6 months) with conventional glucocorticoid therapy (at baseline) were made. Continuous data between baseline and 6 months were compared by paired t tests.|
1642792|NCT01859143|3020079|Superiority or Other||Percent difference|3.0|||||2-Sided|95.0|-8.7|12.0|||||Headache within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642793|NCT01859143|3020079|Superiority or Other||Percent difference|4.4|||||2-Sided|95.0|-5.3|11.2|||||Decreased activity (tiredness) within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642794|NCT01859143|3020079|Superiority or Other||Percent difference|2.5|||||2-Sided|95.0|-3.3|5.5|||||Chills within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642795|NCT01859143|3020079|Superiority or Other||Percent difference|0.3|||||2-Sided|95.0|-7.8|4.8|||||Muscle aches within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642796|NCT01859143|3020079|Superiority or Other||Percent difference|0.4|||||2-Sided|95.0|-5.3|2.6|||||Vomiting within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642797|NCT01859143|3020079|Superiority or Other||Percent difference|0.3|||||2-Sided|95.0|-8.6|5.7|||||Cough within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642798|NCT01859143|3020079|Superiority or Other||Percent difference|4.4|||||2-Sided|95.0|-5.3|11.2|||||Sore throat within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642799|NCT01859143|3020079|Superiority or Other||Percent difference|9.7|||||2-Sided|95.0|-1.8|18.6|||||Runny nose within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642800|NCT01859143|3020079|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-6.1|1.8|||||Fever >103 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642801|NCT01859143|3020079|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-6.1|1.8|||||Fever >102 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642802|NCT01859143|3020079|Superiority or Other||Percent difference|0.8|||||2-Sided|95.0|-4.9|3.3|||||Fever >=101 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642803|NCT01859143|3020079|Superiority or Other||Percent difference|1.2|||||2-Sided|95.0|-4.5|3.9|||||Fever >100 degrees F within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642804|NCT01859143|3020079|Superiority or Other||Percent difference|12.3|||||2-Sided|95.0|-1.6|24.4|||||Any symptom within 14 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642805|NCT01859143|3020079|Superiority or Other||Percent difference|3.5|||||2-Sided|95.0|-7.8|11.9|||||Headache within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642806|NCT01859143|3020079|Superiority or Other||Percent difference|3.2|||||2-Sided|95.0|-6.5|9.8|||||Decreased activity (tiredness) within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642807|NCT01859143|3020079|Superiority or Other||Percent difference|1.7|||||2-Sided|95.0|-4.1|4.4|||||Chills within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642808|NCT01859143|3020079|Superiority or Other||Percent difference|-0.1|||||2-Sided|95.0|-8.0|4.3|||||Muscle aches within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642809|NCT01859143|3020079|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-6.1|1.8|||||Vomiting within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642810|NCT01859143|3020079|Superiority or Other||Percent difference|-0.5|||||2-Sided|95.0|-9.3|4.7|||||Cough within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642811|NCT01859143|3020079|Superiority or Other||Percent difference|6.2|||||2-Sided|95.0|-2.2|11.6|||||Sore throat within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642812|NCT01859143|3020079|Superiority or Other||Percent difference|8.9|||||2-Sided|95.0|-2.6|17.7|||||Runny nose within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642813|NCT01859143|3020079|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-6.1|1.8|||||Fever >103 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642814|NCT01859143|3020079|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-6.1|1.8|||||Fever >102 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642815|NCT01859143|3020079|Superiority or Other||Percent difference|0.8|||||2-Sided|95.0|-4.9|3.3|||||Fever >100 degrees F within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642816|NCT01859143|3020079|Superiority or Other||Percent difference|11.9|||||2-Sided|95.0|-1.9|23.9|||||Any symptom within 7 days of vaccination: Difference in percentage of participants and 95% CI were constructed based on Chan and Zhang’s method.||
1642817|NCT01859143|3020080|Non-Inferiority or Equivalence|Pre-specified equivalence criterion for fever within 7 days of vaccination mentioned that the upper limit of 95 percent (%) confidence interval (CI) for difference in percentage of participants with fever >=101 degrees F should be less than 5 percentage points.|Percent difference|0.4|||||2-Sided|95.0|-5.3|2.6|||||A two-sided 95% CI was constructed using the exact method based on the score statistic proposed by Chan and Zhang.||
1642818|NCT01858636|3020092|Superiority or Other||||||<|0.0001|||||||Fisher Exact|A one-sided Fisher’s exact test was performed with a 95% lower confidence bound of 96.4%||Ho: St ≤ 90% Ha: St > 90%, where St is the proportion of deployed subjects achieving hemostasis within 5 minutes.|
1642819|NCT01858636|3020093|Superiority or Other|||||||0.0029|||||||Fisher Exact|A one-sided Fisher’s exact test was performed with a 95% upper confidence bound of 5.5%||Ho: Pt ≥ 8% Ha: Pt < 8%, where Pt is the proportion of deployed subjects with a protocol-defined vascular complication.|
1642820|NCT01858532|3020095|Other||Hazard Ratio (HR)|0.884||||0.447|2-Sided|95.0|0.643|1.215|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.|
1642821|NCT01858532|3020095|Other|||||||0.446|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.|
1642822|NCT01858532|3020096|Other||Hazard Ratio (HR)|0.72||||0.002|2-Sided|95.0|0.58|0.89|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.|
1642823|NCT01858532|3020097|Other||Hazard Ratio (HR)|0.801||||0.049|2-Sided|95.0|0.642|0.999|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.|
1642824|NCT01858532|3020097|Other|||||||0.089|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.|
1642825|NCT01858532|3020098|Other||Hazard Ratio (HR)|0.779||||0.112|2-Sided|95.0|0.573|1.06|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.|
1642826|NCT01858532|3020098|Other||||||=|0|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.|
1642827|NCT01858532|3020099|Other||Hazard Ratio (HR)|0.654|||=|0|2-Sided|95.0|0.488|0.878|||Regression, Cox|||A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.|
1642828|NCT01858532|3020099|Other||||||=|0|||||||Stratified log-rank test|||The endpoint was analyzed using the stratified log-rank test for treatment comparison.|
1642829|NCT01857869|3020192|Other||1-Relative Risk|62.5||||0.0009|2-Sided|95.0|29.4|80.1||Two-sided Fisher Exact test was used for the comparison of malaria incidence after first/second CHMI between the compared groups.|Mantel Haenszel|||Vaccine efficacy (VE) was defined as 100*(1-Relative Risk [RR]).|
1642830|NCT01857869|3020192|Other||1-Relative Risk|86.7|||<|0.0001|2-Sided|95.0|66.8|94.6||Two-sided Fisher Exact test was used for the comparison of malaria incidence after first/second CHMI between the compared groups.|Mantel Haenszel|||Vaccine efficacy (VE) was defined as 100*(1-Relative Risk [RR]).|
1642831|NCT01857713|3020198|Non-Inferiority or Equivalence|It was assumed that the study would be successful if the mean % reduction is significantly greater than 25%. Assuming a 35% reduction in RSI, a power of 80%, one-sided significance level of 0.05, 85 subjects are required for the study. It was decided to recruit up to 100 subjects for this study.|||||<|0.05|||||||t-test, 1 sided|||The sample size was based on the primary effectiveness variable (% reduction in RSI from Baseline to Week 4). It was assumed that the study would be successful if the mean % reduction is significantly greater than 25%. Assuming a 35% reduction in RSI, a power of 80%, one-sided significance level of 0.05, 85 subjects are required for the study. It was decided to recruit up to 100 subjects for this study.|
1642832|NCT01857622|3020199|Superiority or Other||Cox Proportional Hazard|2.7|||||2-Sided|95.0|-15.4|25.2|||||||
1642833|NCT01857622|3020199|Superiority or Other||Cox Proportional Hazard|3.8|||||2-Sided|95.0|-14.7|26.8|||||||
1642834|NCT01857583|3020205|Superiority or Other||Cox Proportional Hazard|17.3|||||2-Sided|95.0|-10.2|42.1|||||||
1642835|NCT01857583|3020205|Superiority or Other||Cox Proportional Hazard|12.6|||||2-Sided|95.0|-10.0|33.6|||||||
1642836|NCT01857362|3020212|Non-Inferiority or Equivalence|Bioequivalence is established if the 90% confidence interval for the ratio is completely within the acceptance range (0.80-1.25)|ratio of geometric means|0.0|||||2-Sided|90.0|0.0|1.0|||||||
1642837|NCT01857362|3020213|Non-Inferiority or Equivalence|Bioequivalence is established if the 90% confidence interval for the ratio is completely within the acceptance range (0.80-1.25)|Ratio of geomectric means|1.0|||||2-Sided|90.0|0.0|1.0|||||||
1642838|NCT01857232|3020233|Superiority|||||||0.1332|||||||Chi-squared, Corrected|1-sided|||
1642839|NCT01857232|3020233|Superiority|||||||0.1651|||||||Chi-squared, Corrected|1-sided|||
1642840|NCT01857232|3020233|Superiority|||||||0.0235|||||||Chi-squared, Corrected|1-sided|||
1642841|NCT01857232|3020234|Superiority|||||||0.1041|||||||Regression, Logistic||||
1642842|NCT01857232|3020234|Superiority|||||||0.0987|||||||Regression, Logistic||||
1642843|NCT01857232|3020234|Superiority|||||||0.004|||||||Regression, Logistic||||
1642887|NCT01856686|3020288|Superiority or Other|||||||0.15544|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642844|NCT01857063|3020245|Superiority or Other||Difference in LS Means|0.02||||0.161|2-Sided|95.0|-0.01|0.05||Longitudinal Data Analysis (LDA) model with baseline sneezing score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA||||
1642845|NCT01857063|3020246|Superiority or Other||Difference in LS Means|-0.03||||0.182|2-Sided|95.0|-0.06|0.01||Longitudinal Data Analysis (LDA) model with baseline nasal discharge score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA||||
1642846|NCT01857063|3020247|Superiority or Other||Difference in LS Means|0.0||||0.974|2-Sided|95.0|-0.07|0.07||Longitudinal Data Analysis (LDA) model with baseline nasal congestion score as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA||||
1642847|NCT01857063|3020248|Superiority or Other||Difference in LS Means|0.0||||0.953|2-Sided|95.0|-0.17|0.16||Longitudinal Data Analysis (LDA) model with baseline Weighted TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|LDA||||
1642848|NCT01857063|3020250|Superiority or Other||Difference in Least Squares (LS) Means|-0.01||||0.913|2-Sided|95.0|-0.11|0.1||Longitudinal Data Analysis (LDA) model with baseline TNSS as a covariate, sequence, treatment and period as fixed effects and participant as a random effect.|Longitudinal Data Analysis (LDA)||||
1642849|NCT01856907|3020253|Superiority|||||||0.9|||||||Fisher Exact||||
1642850|NCT01856907|3020254|Superiority|||||||0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1642851|NCT01856907|3020255|Superiority|||||||0.004|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1642852|NCT01856907|3020256|Superiority|||||||0.002|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1642853|NCT01856907|3020257|Superiority|||||||0.042|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1642854|NCT01856907|3020258|Superiority|||||||0.014|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1642855|NCT01856907|3020259|Superiority|||||||0.017|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1642856|NCT01856907|3020260|Superiority|||||||0.047|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1642857|NCT01856907|3020261|Superiority|||||||0.034|||||||ANOVA|||Factorial repeated measures ANOVA with Bonferroni contrast test|
1642858|NCT01856907|3020262|Superiority|||||||0.044|||||||ANOVA|||Subjects (SS)/ Treatment Group x repeated measures (visit) design|
1642859|NCT01856907|3020263|Superiority|||||||0.035|||||||McNemar|||Study change from dysglycemia to normal glucose state|
1642860|NCT01856790|3020265|Superiority or Other (legacy)|||||||0.005|||||||Wilcoxon Matched Pairs signed rank tests||||
1642861|NCT01856790|3020266|Superiority or Other (legacy)|||||||0.001|||||||Wilcoxon Matched Pairs signed rank tests||||
1642862|NCT01856790|3020270|Superiority or Other (legacy)|||||||0.97|||||||Wilcoxon Matched Pairs signed rank tests||||
1642863|NCT01856790|3020272|Superiority or Other (legacy)|||||||0.002|||||||Wilcoxon Matched Pairs signed rank tests||||
1642864|NCT01856790|3020273|Superiority or Other (legacy)|||||||0.05|||||||Wilcoxon Matched Pairs signed rank tests||||
1642865|NCT01856764|3020274|Superiority or Other||LS Mean Difference|-1.56|Standard Error of the Mean|0.596||0.013|2-Sided|95.0|-2.7656|-0.3492||MMRM model: Assessment of Pruritus change from baseline = treatment + visit + treatment by visit interaction + baseline Assessment of Pruritus score|Mixed Models Analysis||||
1642866|NCT01856764|3020275|Superiority or Other||LS Mean Difference|-5.91|Standard Error of the Mean|3.454||0.095|2-Sided|95.0|-12.9134|1.0835||MMRM model: TEWL change from baseline = treatment + visit + treatment by visit interaction + baseline TEWL score|Mixed Models Analysis||||
1642867|NCT01856764|3020276|Superiority or Other||LS Mean Difference|-0.55|Standard Error of the Mean|0.496||0.276|2-Sided|95.0|-1.5542|0.4574||Mixed Model Repeated Measures (MMRM) Model: SCORAD change from baseline = treatment + visit + treatment by visit interaction + baseline SCORAD score|Mixed Models Analysis||||
1642868|NCT01856712|3020280|Superiority||Odds Ratio (OR)|1.71|||||2-Sided|95.0|0.35|9.98|||||||
1642869|NCT01856686|3020281|Superiority or Other|||||||0.00775|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642870|NCT01856686|3020281|Superiority or Other|||||||0.00413|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642871|NCT01856686|3020281|Superiority or Other|||||||0.90843|||||||ANCOVA|||Between-Group Comparison|
1642872|NCT01856686|3020282|Superiority or Other|||||||0.00776|||||||Pairedt-test|||Within-group comparisons between the baseline and 3 month data|
1642873|NCT01856686|3020282|Superiority or Other|||||||0.08812|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642874|NCT01856686|3020282|Superiority or Other|||||||0.23226|||||||ANCOVA|||Between-Group Comparison|
1642875|NCT01856686|3020283|Superiority or Other|||||||0.07548|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642876|NCT01856686|3020283|Superiority or Other|||||||0.17374|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642877|NCT01856686|3020283|Superiority or Other|||||||0.45013|||||||ANCOVA|||Between-Group Comparison|
1642878|NCT01856686|3020285|Superiority or Other|||||||0.37046|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642879|NCT01856686|3020285|Superiority or Other|||||||0.08739|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642880|NCT01856686|3020285|Superiority or Other|||||||0.48336|||||||ANCOVA|||Between-Group Comparison|
1642881|NCT01856686|3020286|Superiority or Other|||||||0.00595|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642882|NCT01856686|3020286|Superiority or Other|||||||0.0071|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642883|NCT01856686|3020286|Superiority or Other|||||||0.50964|||||||ANCOVA|||Between-Group Comparison|
1642884|NCT01856686|3020287|Superiority or Other|||||||0.19739|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642885|NCT01856686|3020287|Superiority or Other|||||||0.27945|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642888|NCT01856686|3020288|Superiority or Other|||||||0.00092|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642889|NCT01856686|3020288|Superiority or Other|||||||0.17383|||||||ANCOVA|||Between-Group Comparison|
1642890|NCT01856686|3020289|Superiority or Other|||||||0.09331|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642891|NCT01856686|3020289|Superiority or Other|||||||0.94574|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642892|NCT01856686|3020289|Superiority or Other|||||||0.05158|||||||ANCOVA|||Between-Group Comparison|
1642893|NCT01856686|3020290|Superiority or Other|||||||0.58323|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642894|NCT01856686|3020290|Superiority or Other|||||||0.97213|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642895|NCT01856686|3020290|Superiority or Other|||||||0.83929|||||||ANCOVA|||Between-Group Comparison|
1642896|NCT01856686|3020291|Superiority or Other|||||||0.85428|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642897|NCT01856686|3020291|Superiority or Other|||||||0.94574|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642898|NCT01856686|3020291|Superiority or Other|||||||0.94449|||||||ANCOVA|||Between-Group Comparison|
1642899|NCT01856686|3020292|Superiority or Other|||||||0.28019|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642900|NCT01856686|3020292|Superiority or Other|||||||0.00013|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642901|NCT01856686|3020292|Superiority or Other|||||||0.33027|||||||ANCOVA|||Between-Group Comparison|
1642902|NCT01856686|3020293|Superiority or Other|||||||0.61613|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642903|NCT01856686|3020293|Superiority or Other|||||||0.07965|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642904|NCT01856686|3020293|Superiority or Other|||||||0.73209|||||||ANCOVA|||Between-Group Comparison|
1642905|NCT01856686|3020294|Superiority or Other|||||||0.0109|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642906|NCT01856686|3020294|Superiority or Other|||||||0.27795|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642907|NCT01856686|3020294|Superiority or Other|||||||0.08946|||||||ANCOVA|||Between-Group Comparison|
1642908|NCT01856686|3020295|Superiority or Other|||||||0.42314|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642909|NCT01856686|3020295|Superiority or Other|||||||0.50704|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642910|NCT01856686|3020295|Superiority or Other|||||||0.92193|||||||ANCOVA|||Between-Group Comparison|
1642911|NCT01856686|3020296|Superiority or Other|||||||1|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642912|NCT01856686|3020296|Superiority or Other|||||||0.0082|||||||Paired t-test|||Within-group changes|
1642913|NCT01856686|3020296|Superiority or Other|||||||0.10036|||||||ANCOVA|||Between-Group Comparison|
1642914|NCT01856686|3020297|Superiority or Other|||||||0.47616|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642915|NCT01856686|3020297|Superiority or Other|||||||0.27795|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642916|NCT01856686|3020297|Superiority or Other|||||||0.71152|||||||ANCOVA|||Between-Group Comparison|
1642917|NCT01856686|3020298|Superiority or Other|||||||0.81844|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642918|NCT01856686|3020298|Superiority or Other|||||||0.44929|||||||Paired t-test|||Within-group comparisons between the baseline and 3 month data|
1642919|NCT01856686|3020298|Superiority or Other|||||||0.56593|||||||ANCOVA|||Between-Group Comparison|
1642920|NCT01856595|3020307|Superiority or Other||Ratio|1.18|Standard Error of the Mean|1.112||0.1318|2-Sided|90.0|0.98|1.41||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642921|NCT01856595|3020307|Superiority or Other||Ratio|0.95|Standard Error of the Mean|1.119||0.6833|2-Sided|90.0|0.79|1.15||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642922|NCT01856595|3020308|Superiority or Other||Ratio|1.08|Standard Error of the Mean|1.084||0.3703|2-Sided|90.0|0.94|1.23||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642923|NCT01856595|3020308|Superiority or Other||Ratio|1.14|Standard Error of the Mean|1.095||0.1617|2-Sided|90.0|0.98|1.32||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642924|NCT01856595|3020309|Superiority or Other||Ratio|1.08|Standard Error of the Mean|1.079||0.319|2-Sided|90.0|0.95|1.23||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642925|NCT01856595|3020309|Superiority or Other||Ratio|1.0|Standard Error of the Mean|1.076||0.967|2-Sided|90.0|0.88|1.13||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1643012|NCT01855997|3020489|Superiority or Other|||||||9.27e-06|||||||t-test, 2 sided|||rs1937590|
1643013|NCT01855997|3020489|Superiority or Other|||||||3.39e-06|||||||t-test, 2 sided|||rs2803073|
1642926|NCT01856595|3020309|Superiority or Other||Ratio|0.93|Standard Error of the Mean|1.082||0.3425|2-Sided|90.0|0.81|1.06||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642927|NCT01856595|3020309|Superiority or Other||Ratio|0.98|Standard Error of the Mean|1.079||0.8144|2-Sided|90.0|0.87|1.11||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642928|NCT01856595|3020309|Superiority or Other||Ratio|1.06|Standard Error of the Mean|1.079||0.4579|2-Sided|90.0|0.93|1.2||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642929|NCT01856595|3020310|Superiority or Other||Ratio|1.2|Standard Error of the Mean|1.173||0.2519|2-Sided|90.0|0.92|1.58||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642930|NCT01856595|3020310|Superiority or Other||Ratio|0.69|Standard Error of the Mean|1.181||0.034|2-Sided|90.0|0.52|0.92||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642931|NCT01856595|3020311|Superiority or Other||Ratio|1.09|Standard Error of the Mean|1.146||0.5178|2-Sided|90.0|0.87|1.37||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642932|NCT01856595|3020311|Superiority or Other||Ratio|1.12|Standard Error of the Mean|1.154||0.4405|2-Sided|90.0|0.88|1.42||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642933|NCT01856595|3020312|Superiority or Other||Ratio|0.98|Standard Error of the Mean|1.12||0.8437|2-Sided|90.0|0.81|1.18||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642934|NCT01856595|3020312|Superiority or Other||Ratio|0.89|Standard Error of the Mean|1.115||0.2883|2-Sided|90.0|0.74|1.07||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642935|NCT01856595|3020312|Superiority or Other||Ratio|0.83|Standard Error of the Mean|1.126||0.1258|2-Sided|90.0|0.68|1.01||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642936|NCT01856595|3020312|Superiority or Other||Ratio|0.93|Standard Error of the Mean|1.124||0.5158|2-Sided|90.0|0.76|1.13||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642937|NCT01856595|3020312|Superiority or Other||Ratio|0.98|Standard Error of the Mean|1.123||0.8723|2-Sided|90.0|0.81|1.19||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642938|NCT01856595|3020316|Superiority or Other||Ratio|0.88|Standard Error of the Mean|1.079||0.0908|2-Sided|90.0|0.77|1.0||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642939|NCT01856595|3020316|Superiority or Other||Ratio|0.77|Standard Error of the Mean|1.083||0.0027|2-Sided|90.0|0.68|0.88||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642940|NCT01856595|3020317|Superiority or Other||Ratio|0.88|Standard Error of the Mean|1.068||0.0908|2-Sided|90.0|0.77|1.0||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642941|NCT01856595|3020317|Superiority or Other||Ratio|0.98|Standard Error of the Mean|1.075||0.7804|2-Sided|90.0|0.87|1.1||Two-sided p-values are from analysis of ANCOVA model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642942|NCT01856595|3020318|Superiority or Other||Ratio|0.77|Standard Error of the Mean|1.065|<|0.0001|2-Sided|90.0|0.69|0.85||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642943|NCT01856595|3020318|Superiority or Other||Ratio|0.82|Standard Error of the Mean|1.062|<|0.0012|2-Sided|90.0|0.74|0.9||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1643014|NCT01855997|3020489|Superiority or Other|||||||1.37e-06|||||||t-test, 2 sided|||rs9287655|
1642944|NCT01856595|3020318|Superiority or Other||Ratio|0.85|Standard Error of the Mean|1.064|<|0.0106|2-Sided|90.0|0.77|0.94||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642945|NCT01856595|3020318|Superiority or Other||Ratio|0.86|Standard Error of the Mean|1.065|<|0.0172|2-Sided|90.0|0.77|0.95||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642946|NCT01856595|3020318|Superiority or Other||Ratio|0.99|Standard Error of the Mean|1.066|<|0.853|2-Sided|90.0|0.89|1.1||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate using the natural log-transformed AUC0-4. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642947|NCT01856595|3020319|Superiority or Other||Least Square Mean Difference (Net)|-11.89|Standard Error of the Mean|7.321||0.1133|2-Sided|90.0|-24.26|0.48||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642948|NCT01856595|3020319|Superiority or Other||Least Square Mean Difference (Net)|-29.43|Standard Error of the Mean|7.609||0.0005|2-Sided|90.0|-42.28|-16.57||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642949|NCT01856595|3020320|Superiority or Other||Least Square Mean Difference (Net)|-19.33|Standard Error of the Mean|8.777||0.0299||90.0|-33.89|-4.76||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642950|NCT01856595|3020320|Superiority or Other||Least Square Mean Difference (Net)|10.47|Standard Error of the Mean|9.621||0.279|2-Sided|90.0|-5.5|26.43||Two-sided p-values are from ANCOVA model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642951|NCT01856595|3020321|Superiority or Other||Least Square Mean Difference (Net)|-42.39|Standard Error of the Mean|8.34|<|0.0001|2-Sided|90.0|-56.23|-28.55||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642952|NCT01856595|3020321|Superiority or Other||Least Square Mean Difference (Net)|-32.33|Standard Error of the Mean|8.038|<|0.0001|2-Sided|90.0|-45.66|-18.99||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642953|NCT01856595|3020321|Superiority or Other||Least Square Mean Difference (Net)|-26.59|Standard Error of the Mean|8.309|<|0.0018|2-Sided|90.0|-40.38|-12.8||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642954|NCT01856595|3020321|Superiority or Other||Least Square Mean Difference (Net)|-21.64|Standard Error of the Mean|8.334|<|0.0108|2-Sided|90.0|-35.47|-7.81||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642955|NCT01856595|3020321|Superiority or Other||Least Square Mean Difference (Net)|-2.77|Standard Error of the Mean|8.532|<|0.7457|2-Sided|90.0|-16.93|11.38||Two-sided p-values are from analysis of Covariance (ANCOVA) model with treatment as a factor and baseline value as a covariate. P-values are not adjusted for multiple comparisons.|ANCOVA|||Placebo was the Reference and each of the active doses was the Test.|
1642956|NCT01856270|3020407|Superiority||Mean Difference (Final Values)|-1.8||||0.089|2-Sided|95.0|-3.8|0.3||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)||
1642957|NCT01856270|3020408|Superiority||Mean Difference (Final Values)|27.3||||0.041|2-Sided|95.0|1.2|53.3||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)||
1642958|NCT01856270|3020409|Superiority||Mean Difference (Final Values)|2.4||||0.444|2-Sided|95.0|-4.0|8.8||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)||
1642959|NCT01856270|3020410|Superiority||Mean Difference (Final Values)|0.3||||0.583|2-Sided|95.0|-0.9|1.6||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)||
1642960|NCT01856270|3020411|Superiority||Mean Difference (Final Values)|1.0||||0.306|2-Sided|95.0|-1.0|2.9||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)||
1642961|NCT01856270|3020412|Superiority||Mean Difference (Final Values)|-0.8||||0.684|2-Sided|95.0|-5.1|3.4||A priori significance threshold α=.05|t-test, 2 sided||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed)||
1642962|NCT01856270|3020413|Superiority||Difference of proportions|0.093||||0.456|2-Sided|95.0|-0.106|0.286||A priori significance threshold α=.05|Fisher Exact||Estimate is the effect observed in the Immediate group (i.e. Immediate - Delayed). Confidence interval estimation method from Wallenstein (1997).||
1643015|NCT01855997|3020490|Superiority or Other|||||||9.18e-06|||||||t-test, 2 sided|||rs9324018|
1643016|NCT01855997|3020490|Superiority or Other|||||||4.87e-06|||||||t-test, 2 sided|||rs7968170|
1643017|NCT01855997|3020490|Superiority or Other|||||||8.34e-06|||||||t-test, 2 sided|||rs2189452|
1643018|NCT01855997|3020491|Superiority or Other|||||||4.89e-06|||||||t-test, 2 sided|||rs9324018|
1643019|NCT01855997|3020491|Superiority or Other|||||||5.96e-06|||||||t-test, 2 sided|||rs2189452|
1642963|NCT01856270|3020414|Superiority|The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).|Difference of proportions|0.194||||0.017|1-Sided|95.0|0.057|||A priori significance threshold α=.05|Fisher Exact||Confidence interval estimation method from Wallenstein (1997). 56 of 148 participants (at 3 mo post) in the Natural History study reported pain >=6.|A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening|
1642964|NCT01856270|3020415|Superiority|The data from this study was compared with the data from the Natural History of Headache after Mild TBI which was previously published (Lucas, Hoffman, Bell, Dikmen. (2014), A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia (34) 93-102).|Difference of proportions|0.114||||0.101|1-Sided|95.0|-0.017|||A priori significance threshold α=.05|Fisher Exact||Confidence interval estimation method from Wallenstein (1997). 71 of 205 participants (at 3 Mo post) in the Natural History study endorsed having a headache more than once per week.|A positive difference of proportions would indicate an improvement in the Amitriptyline sample, while a negative difference would indicate a worsening.|
1642965|NCT01856257|3020446|Superiority||Mean Difference (Final Values)|4.82||||0.531|2-Sided|95.0|-10.481|20.121|||Mixed Models Analysis||P-value estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 3 to Group 1.||
1642966|NCT01856257|3020446|Superiority||Mean Difference (Final Values)|3.512||||0.544|2-Sided|95.0|-7.999|15.024|||Mixed Models Analysis||The p-value, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 2 to Group 1.||
1642967|NCT01855997|3020476|Superiority or Other|||||||7.2e-06|||||||t-test, 2 sided|||rs6592052|
1642968|NCT01855997|3020477|Superiority or Other|||||||5.21e-06|||||||t-test, 2 sided|||rs16943470|
1642969|NCT01855997|3020477|Superiority or Other|||||||8.78e-06|||||||t-test, 2 sided|||rs6592052|
1642970|NCT01855997|3020477|Superiority or Other|||||||4.51e-06|||||||t-test, 2 sided|||rs10491723|
1642971|NCT01855997|3020477|Superiority or Other|||||||7.38e-06|||||||t-test, 2 sided|||rs10814834|
1642972|NCT01855997|3020478|Superiority or Other|||||||4.8e-07|||||||t-test, 2 sided|||rs7549785|
1642973|NCT01855997|3020479|Superiority or Other|||||||4.8e-07|||||||t-test, 2 sided|||rs7549785|
1642974|NCT01855997|3020480|Superiority or Other|||||||9.9e-06|||||||t-test, 2 sided|||rs12992677|
1642975|NCT01855997|3020481|Superiority or Other|||||||5.58e-06|||||||t-test, 2 sided|||rs12992677|
1642976|NCT01855997|3020482|Superiority or Other|||||||8.02e-06|||||||t-test, 2 sided|||rs2279519|
1642977|NCT01855997|3020482|Superiority or Other|||||||5.81e-06|||||||t-test, 2 sided|||rs2370220|
1642978|NCT01855997|3020482|Superiority or Other|||||||9.97e-06|||||||t-test, 2 sided|||rs10978436|
1642979|NCT01855997|3020482|Superiority or Other|||||||5.93e-06|||||||t-test, 2 sided|||rs993147|
1642980|NCT01855997|3020483|Superiority or Other|||||||5.31e-06|||||||t-test, 2 sided|||rs216312|
1642981|NCT01855997|3020483|Superiority or Other|||||||1.18e-06|||||||t-test, 2 sided|||rs9287655|
1642982|NCT01855997|3020484|Superiority or Other|||||||4.5e-06|||||||t-test, 2 sided|||rs7968170|
1642983|NCT01855997|3020484|Superiority or Other|||||||9.46e-06|||||||t-test, 2 sided|||rs9691873|
1642984|NCT01855997|3020484|Superiority or Other|||||||5.53e-06|||||||t-test, 2 sided|||rs1692423|
1642985|NCT01855997|3020484|Superiority or Other|||||||5.79e-06|||||||t-test, 2 sided|||rs1692421|
1642986|NCT01855997|3020484|Superiority or Other|||||||6.29e-06|||||||t-test, 2 sided|||rs6443144|
1642987|NCT01855997|3020485|Superiority or Other|||||||7.17e-06|||||||t-test, 2 sided|||rs4821558|
1642988|NCT01855997|3020485|Superiority or Other|||||||8.85e-06|||||||t-test, 2 sided|||rs11870323|
1642989|NCT01855997|3020485|Superiority or Other|||||||8.28e-06|||||||t-test, 2 sided|||rs11158827|
1642990|NCT01855997|3020485|Superiority or Other|||||||7.29e-06|||||||t-test, 2 sided|||rs8012912|
1642991|NCT01855997|3020485|Superiority or Other|||||||5.71e-06|||||||t-test, 2 sided|||rs9691873|
1642992|NCT01855997|3020485|Superiority or Other|||||||8.94e-06|||||||t-test, 2 sided|||rs1403069|
1642993|NCT01855997|3020485|Superiority or Other|||||||7.8e-07|||||||t-test, 2 sided|||rs6443144|
1642994|NCT01855997|3020485|Superiority or Other|||||||7.43e-06|||||||t-test, 2 sided|||exm2265462|
1642995|NCT01855997|3020485|Superiority or Other|||||||7.02e-06|||||||t-test, 2 sided|||rs2082881|
1642996|NCT01855997|3020485|Superiority or Other|||||||7.02e-06|||||||t-test, 2 sided|||rs1550115|
1642997|NCT01855997|3020485|Superiority or Other|||||||8.05e-06|||||||t-test, 2 sided|||rs1550116|
1642998|NCT01855997|3020486|Superiority or Other|||||||7.41e-06|||||||t-test, 2 sided|||rs6015181|
1642999|NCT01855997|3020486|Superiority or Other|||||||9.5e-06|||||||t-test, 2 sided|||rs2302503|
1643000|NCT01855997|3020487|Superiority or Other|||||||5.77e-06|||||||t-test, 2 sided|||rs715243|
1643001|NCT01855997|3020487|Superiority or Other|||||||3.68e-06|||||||t-test, 2 sided|||rs17037122|
1643002|NCT01855997|3020488|Superiority or Other|||||||8.64e-06|||||||t-test, 2 sided|||rs9324018|
1643003|NCT01855997|3020488|Superiority or Other|||||||9.97e-06|||||||t-test, 2 sided|||rs2077415|
1643004|NCT01855997|3020488|Superiority or Other|||||||4.97e-06|||||||t-test, 2 sided|||rs7042473|
1643005|NCT01855997|3020488|Superiority or Other|||||||5.62e-06|||||||t-test, 2 sided|||rs2945861|
1643006|NCT01855997|3020488|Superiority or Other|||||||8.46e-06|||||||t-test, 2 sided|||rs10236906|
1643007|NCT01855997|3020489|Superiority or Other|||||||9.82e-06|||||||t-test, 2 sided|||rs1152537|
1643008|NCT01855997|3020489|Superiority or Other|||||||1.25e-06|||||||t-test, 2 sided|||rs9324018|
1643009|NCT01855997|3020489|Superiority or Other|||||||5.68e-06|||||||t-test, 2 sided|||rs1495471|
1643010|NCT01855997|3020489|Superiority or Other|||||||4.55e-06|||||||t-test, 2 sided|||rs1997894|
1643011|NCT01855997|3020489|Superiority or Other|||||||1.66e-06|||||||t-test, 2 sided|||rs2945861|
1643022|NCT01855997|3020493|Superiority or Other|||||||7.27e-06|||||||t-test, 2 sided|||rs715243|
1643023|NCT01855997|3020493|Superiority or Other|||||||7.08e-06|||||||t-test, 2 sided|||rs10475403|
1643024|NCT01855997|3020493|Superiority or Other|||||||1.53e-06|||||||t-test, 2 sided|||rs17037122|
1643025|NCT01855997|3020494|Superiority or Other|||||||7.57e-06|||||||t-test, 2 sided|||rs6576456|
1643026|NCT01855997|3020494|Superiority or Other|||||||5.23e-06|||||||t-test, 2 sided|||exm1010813|
1643027|NCT01855997|3020494|Superiority or Other|||||||2.21e-06|||||||t-test, 2 sided|||rs16924016|
1643028|NCT01855997|3020494|Superiority or Other|||||||4.35e-06|||||||t-test, 2 sided|||rs1913484|
1643029|NCT01855997|3020494|Superiority or Other|||||||4.26e-06|||||||t-test, 2 sided|||rs1040084|
1643030|NCT01855997|3020494|Superiority or Other|||||||6.96e-06|||||||t-test, 2 sided|||exm2237722|
1643031|NCT01855997|3020494|Superiority or Other|||||||6.27e-06|||||||t-test, 2 sided|||rs9973954|
1643032|NCT01855997|3020495|Superiority or Other|||||||4.94e-06|||||||t-test, 2 sided|||exm2267780|
1643033|NCT01855997|3020495|Superiority or Other|||||||9.12e-06|||||||t-test, 2 sided|||rs8027115|
1643034|NCT01855997|3020495|Superiority or Other|||||||2.89e-06|||||||t-test, 2 sided|||rs2899723|
1643035|NCT01855997|3020495|Superiority or Other|||||||7.3e-07|||||||t-test, 2 sided|||rs16924016|
1643036|NCT01855997|3020495|Superiority or Other|||||||7.48e-06|||||||t-test, 2 sided|||exm2237722|
1643037|NCT01855997|3020496|Superiority or Other|||||||4.97e-06|||||||t-test, 2 sided|||rs2980231|
1643038|NCT01855997|3020496|Superiority or Other|||||||4.97e-06|||||||t-test, 2 sided|||rs2014238|
1643039|NCT01855997|3020496|Superiority or Other|||||||4.52e-06|||||||t-test, 2 sided|||rs9496139|
1643040|NCT01855997|3020497|Superiority or Other|||||||8.79e-06|||||||t-test, 2 sided|||rs2464266|
1643041|NCT01855997|3020498|Superiority or Other|||||||8.8e-07|||||||t-test, 2 sided|||rs17037122|
1643042|NCT01855997|3020499|Superiority or Other|||||||1.6e-07|||||||t-test, 2 sided|||rs17037122|
1643043|NCT01855997|3020500|Superiority or Other|||||||9.45e-06|||||||t-test, 2 sided|||rs646097|
1643044|NCT01855997|3020500|Superiority or Other|||||||7.31e-06|||||||t-test, 2 sided|||rs1157322|
1643045|NCT01855997|3020500|Superiority or Other|||||||9.46e-06|||||||t-test, 2 sided|||rs1351518|
1643046|NCT01855997|3020500|Superiority or Other|||||||5.73e-06|||||||t-test, 2 sided|||rs1384010|
1643047|NCT01855997|3020501|Superiority or Other|||||||8.99e-06|||||||t-test, 2 sided|||rs1157322|
1643048|NCT01855997|3020501|Superiority or Other|||||||2.07e-06|||||||t-test, 2 sided|||rs11139349|
1643049|NCT01855997|3020502|Superiority or Other|||||||3.1e-06|||||||t-test, 2 sided|||rs11868362|
1643050|NCT01855997|3020502|Superiority or Other|||||||7.94e-06|||||||t-test, 2 sided|||rs1157322|
1643051|NCT01855997|3020502|Superiority or Other|||||||8.44e-06|||||||t-test, 2 sided|||rs1351518|
1643052|NCT01855997|3020502|Superiority or Other|||||||6.66e-06|||||||t-test, 2 sided|||rs1384010|
1643053|NCT01855997|3020503|Superiority or Other|||||||4.07e-06|||||||t-test, 2 sided|||rs11868362|
1643054|NCT01855997|3020503|Superiority or Other|||||||4.04e-06|||||||t-test, 2 sided|||rs7983441|
1643055|NCT01855997|3020503|Superiority or Other|||||||6.08e-06|||||||t-test, 2 sided|||rs1831559|
1643056|NCT01855997|3020503|Superiority or Other|||||||9.52e-06|||||||t-test, 2 sided|||rs11139349|
1643057|NCT01855997|3020503|Superiority or Other|||||||6.74e-06|||||||t-test, 2 sided|||rs6443144|
1643058|NCT01855997|3020503|Superiority or Other|||||||4.7e-06|||||||t-test, 2 sided|||rs11163805|
1643059|NCT01855997|3020504|Superiority or Other|||||||7.72e-06|||||||t-test, 2 sided|||rs12446868|
1643060|NCT01855997|3020504|Superiority or Other|||||||9.25e-06|||||||t-test, 2 sided|||rs1411283|
1643061|NCT01855997|3020504|Superiority or Other|||||||4.59e-06|||||||t-test, 2 sided|||rs12210761|
1643062|NCT01855997|3020505|Superiority or Other|||||||3.72e-06|||||||t-test, 2 sided|||rs247878|
1643063|NCT01855997|3020505|Superiority or Other|||||||3.45e-06|||||||t-test, 2 sided|||rs12446868|
1643064|NCT01855997|3020505|Superiority or Other|||||||5.12e-06|||||||t-test, 2 sided|||rs7983441|
1643065|NCT01855997|3020505|Superiority or Other|||||||7.98e-06|||||||t-test, 2 sided|||rs1831559|
1643066|NCT01855997|3020505|Superiority or Other|||||||6.77e-06|||||||t-test, 2 sided|||rs12210761|
1643067|NCT01855997|3020506|Superiority or Other|||||||1.97e-06|||||||t-test, 2 sided|||rs247878|
1643068|NCT01855997|3020506|Superiority or Other|||||||7.7e-07|||||||t-test, 2 sided|||rs12446868|
1643069|NCT01855997|3020506|Superiority or Other|||||||9.46e-06|||||||t-test, 2 sided|||rs604241|
1643070|NCT01855997|3020506|Superiority or Other|||||||6.05e-06|||||||t-test, 2 sided|||rs7753766|
1643071|NCT01855997|3020506|Superiority or Other|||||||9.87e-06|||||||t-test, 2 sided|||rs1876154|
1643072|NCT01855997|3020507|Superiority or Other|||||||3.7e-07|||||||t-test, 2 sided|||rs247878|
1643073|NCT01855997|3020507|Superiority or Other|||||||4.8e-07|||||||t-test, 2 sided|||rs12446868|
1643074|NCT01855997|3020507|Superiority or Other|||||||7.7e-07|||||||t-test, 2 sided|||rs7983441|
1643075|NCT01855997|3020507|Superiority or Other|||||||9.02e-06|||||||t-test, 2 sided|||rs9555773|
1643076|NCT01855997|3020507|Superiority or Other|||||||2.21e-06|||||||t-test, 2 sided|||rs12584550|
1643077|NCT01855997|3020507|Superiority or Other|||||||6.48e-06|||||||t-test, 2 sided|||rs6492344|
1643078|NCT01855997|3020507|Superiority or Other|||||||3.96e-06|||||||t-test, 2 sided|||rs10851257|
1643079|NCT01855997|3020507|Superiority or Other|||||||1.27e-06|||||||t-test, 2 sided|||rs1831559|
1643080|NCT01855997|3020507|Superiority or Other|||||||9.82e-06|||||||t-test, 2 sided|||rs10824875|
1643081|NCT01855997|3020507|Superiority or Other|||||||7.66e-06|||||||t-test, 2 sided|||rs2812338|
1643082|NCT01855997|3020507|Superiority or Other|||||||5.59e-06|||||||t-test, 2 sided|||rs1876154|
1643083|NCT01855919|3020530|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.1466|2-Sided|95.0|-0.06|0.01||p-value for Work activity impairment|ANCOVA||||
1643084|NCT01855919|3020530|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.0795|2-Sided|95.0|-0.08|0.0||p-value for Work productivity loss|ANCOVA||||
1643085|NCT01855919|3020530|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.0753|2-Sided|95.0|-0.08|0.0||p-value for Impairment at work|ANCOVA||||
1643086|NCT01855919|3020530|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.046|2-Sided|95.0|-0.05|0.0||p-value for Work time missed|ANCOVA||||
1643087|NCT01855919|3020531|Superiority or Other||Mean Difference (Final Values)|0.01||||0.5237|2-Sided|95.0|-0.02|0.03|||ANCOVA||||
1643088|NCT01855919|3020532|Superiority or Other||Mean Difference (Final Values)|3.21||||0.0058|2-Sided|95.0|0.94|5.48||p-value is for Mental Health|ANCOVA||||
1643089|NCT01855919|3020532|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.8042|2-Sided|95.0|-3.55|2.75||p-value for Role(Emotional)|ANCOVA||||
1643090|NCT01855919|3020532|Superiority or Other||Mean Difference (Final Values)|1.63||||0.2529|2-Sided|95.0|-1.17|4.43||p-value for Social Functioning|ANCOVA||||
1643091|NCT01855919|3020532|Superiority or Other||Mean Difference (Final Values)|1.16||||0.4|2-Sided|95.0|-1.54|3.85||p-value for Vitality|ANCOVA||||
1643092|NCT01855919|3020532|Superiority or Other||Mean Difference (Final Values)|2.94||||0.0151|2-Sided|95.0|0.57|5.31||p-value for General Health|ANCOVA||||
1643093|NCT01855919|3020532|Superiority or Other||Mean Difference (Final Values)|1.55||||0.2487|2-Sided|95.0|-1.09|4.19||p-value for Bodily Pain|ANCOVA||||
1643094|NCT01855919|3020532|Superiority or Other||Mean Difference (Final Values)|0.58||||0.7208|2-Sided|95.0|-2.62|3.79||p-value for Role (Physical)|ANCOVA||||
1643095|NCT01855919|3020532|Superiority or Other||Mean Difference (Final Values)|1.27||||0.2581|2-Sided|95.0|-0.93|3.47||p-value for Physical Functioning|ANCOVA||||
1643096|NCT01855919|3020533|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.3012|2-Sided|95.0|-1.03|0.32|||ANCOVA||||
1643097|NCT01855919|3020534|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.0019|2-Sided|95.0|-0.46|-0.1|||Mixed Models Analysis||||
1643098|NCT01855919|3020535|Superiority or Other||Risk Ratio (RR)|1.33||||0.0012|2-Sided|95.0|1.12|1.58|||Mantel Haenszel||||
1643099|NCT01855919|3020536|Superiority or Other||Risk Ratio (RR)|1.43||||0.0003|2-Sided|95.0|1.18|1.75||p-value is for ≥50%|Mantel Haenszel||||
1643100|NCT01855919|3020536|Superiority or Other||Risk Ratio (RR)|1.31||||0.0003|2-Sided|95.0|1.13|1.53||p-value is for ≥30%|Mantel Haenszel||||
1643101|NCT01855919|3020537|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.0442|2-Sided|95.0|-0.69|-0.01||p-value is for Worst pain|Mixed Models Analysis||||
1643102|NCT01855919|3020537|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.0049|2-Sided|95.0|-0.71|-0.13||p-value is for Average Pain|Mixed Models Analysis||||
1643103|NCT01855919|3020538|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.3761|2-Sided|95.0|-0.4|0.15||p-value is for Average of 7 Items|Mixed Models Analysis||||
1643104|NCT01855919|3020538|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.7932|2-Sided|95.0|-0.35|0.27||p-value is for Enjoyment of Life|Mixed Models Analysis||||
1643105|NCT01855919|3020538|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.9424|2-Sided|95.0|-0.32|0.3||p-value is for Sleep|Mixed Models Analysis||||
1643106|NCT01855919|3020538|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.7848|2-Sided|95.0|-0.3|0.23||p-value is for Relationship People|Mixed Models Analysis||||
1643107|NCT01855919|3020538|Superiority or Other||Mean Difference (Final Values)|0.0||||0.991|2-Sided|95.0|-0.33|0.33||p-value is for Normal Work|Mixed Models Analysis||||
1643108|NCT01855919|3020538|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.3902|2-Sided|95.0|-0.45|0.18||p-value is for Walking Ability|Mixed Models Analysis||||
1643109|NCT01855919|3020538|Superiority or Other||Mean Difference (Final Values)|-0.32||||0.0436|2-Sided|95.0|-0.63|-0.01||p-value is for Mood|Mixed Models Analysis||||
1643110|NCT01855919|3020538|Superiority or Other||Mean Difference (Final Values)|-0.31||||0.0874|2-Sided|95.0|-0.66|0.05||p-value is for General Activity|Mixed Models Analysis||||
1643111|NCT01855919|3020538|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.023|2-Sided|95.0|-0.74|-0.05||p-value is for Pain Right Now|Mixed Models Analysis||||
1643112|NCT01855919|3020538|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.0009|2-Sided|95.0|-0.79|-0.21||p-value is for least pain|Mixed Models Analysis||||
1643113|NCT01855919|3020538|Superiority or Other||Median Difference (Final Values)|-0.3||||0.101|2-Sided|95.0|-0.66|0.06||p-value is for worst pain|Mixed Models Analysis||||
1643114|NCT01855919|3020539|Superiority or Other||Mean Difference (Final Values)|-0.64||||0.0439|2-Sided|95.0|-1.25|-0.02|||ANCOVA||||
1643115|NCT01855919|3020540|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.0026|2-Sided|95.0|-0.48|-0.1|||Mixed Models Analysis||||
1643116|NCT01855919|3020541|Superiority or Other||Mean Difference (Final Values)|-0.46||||0.0026|2-Sided|95.0|-0.77|-0.16|||Mixed Models Analysis||||
1643117|NCT01855789|3020549|Superiority||Estimated Mean Difference|0.24|Standard Error of the Mean|0.22|||2-Sided|95.0|-0.21|0.68|||||TCZ + PBO minus TCZ + MTX|ANCOVA model included Week 24 bone erosion as a covariate, treatment group, and the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >/=2.6 to </=3.2), participant anti-TNF exposure (Yes/No), baseline weight-by-dosing group (<80 kg q2w, 80-<100 kg q2w, 80-<100 kg qw, >=100 kg qw).|
1643118|NCT01855789|3020550|Superiority||Low DAS28 Rate Difference|-5.4||||0.3665|2-Sided|95.0|-16.3|5.4|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >=2.6 to <=3.2), baseline weight-by-dosing group (<80 kg q2w, <80 kg qw, 80-<100 kg q2w, 80-<100 kg qw, >=100 kg qw), participant anti-TNF exposure (Yes/No).|
1643119|NCT01855789|3020550|Superiority||Low DAS28 Rate Difference|-13.6||||0.0228|2-Sided|95.0|-24.0|-3.3|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >=2.6 to <=3.2), baseline weight-by-dosing group (<80 kg q2w, <80 kg qw, 80-<100 kg q2w, 80-<100 kg qw, >=100 kg qw), participant anti-TNF exposure (Yes/No).|
1643139|NCT01855750|3020562|Superiority||Hazard Ratio (HR)|0.922||||0.5167|2-Sided|95.0|0.72|1.18|||Log Rank||||
1643252|NCT01852955|3020871|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1643120|NCT01855789|3020551|Superiority||DAS28 Remission Rate Difference|-6.8||||0.3611|2-Sided|95.0|-18.2|4.6|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >=2.6 to <=3.2), baseline weight-by-dosing group (<80 kg q2w, <80 kg qw, 80-<100 kg q2w, 80-<100 kg qw, >=100 kg qw), participant anti-TNF exposure (Yes/No).|
1643121|NCT01855789|3020551|Superiority||DAS28 Remission Rate Difference|-9.5||||0.1062|2-Sided|95.0|-20.9|1.8|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >=2.6 to <=3.2), baseline weight-by-dosing group (<80 kg q2w, <80 kg qw, 80-<100 kg q2w, 80-<100 kg qw, >=100 kg qw), participant anti-TNF exposure (Yes/No).|
1643122|NCT01855789|3020552|Superiority||DAS28 Worsening Rate Difference|3.4||||0.4811|2-Sided|95.0|-6.9|13.7|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 52: Analysis of association between treatment group and worsening in DAS28, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >=2.6 to <=3.2), baseline weight-by-dosing group (<80 kg q2w, <80 kg qw, 80-<100 kg q2w, 80-<100 kg qw, >=100 kg qw), participant anti-TNF exposure (Yes/No).|
1643123|NCT01855789|3020552|Superiority||DAS28 Worsening Rate Difference|7.5||||0.2371|2-Sided|95.0|-2.4|17.3|||Cochran-Mantel-Haenszel||TCZ + PBO minus TCZ + MTX|Week 40: Analysis of association between treatment group and worsening in DAS28, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >=2.6 to <=3.2), baseline weight-by-dosing group (<80 kg q2w, <80 kg qw, 80-<100 kg q2w, 80-<100 kg qw, >=100 kg qw), participant anti-TNF exposure (Yes/No).|
1643124|NCT01855789|3020553|Superiority||ACR 70 Response Rate Difference|-8.2|||||2-Sided|95.0|-19.4|3.1|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24|
1643125|NCT01855789|3020553|Superiority||ACR 70 Response Rate Difference|-11.6||||0.0663|2-Sided|95.0|-22.8|-0.3|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >=2.6 to <=3.2), baseline weight-by-dosing group (<80 kg q2w, <80 kg qw, 80-<100 kg q2w, 80-<100 kg qw, >=100 kg qw), participant anti-TNF exposure (Yes/No).|
1643126|NCT01855789|3020553|Superiority||ACR 70 Response Rate Difference|-8.2||||0.3599|2-Sided|95.0|-19.2|2.9|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >=2.6 to <=3.2), baseline weight-by-dosing group (<80 kg q2w, <80 kg qw, 80-<100 kg q2w, 80-<100 kg qw, >=100 kg qw), participant anti-TNF exposure (Yes/No).|
1643127|NCT01855789|3020554|Superiority||ACR 50 Response Rate Difference|-10.9|||||2-Sided|95.0|-21.4|-0.4|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24|
1643128|NCT01855789|3020554|Superiority||ACR 50 Response Rate Difference|-15.0||||0.013|2-Sided|95.0|-26.2|-3.7|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >=2.6 to <=3.2), baseline weight-by-dosing group (<80 kg q2w, <80 kg qw, 80-<100 kg q2w, 80-<100 kg qw, >=100 kg qw), participant anti-TNF exposure (Yes/No).|
1643129|NCT01855789|3020554|Superiority||ACR 50 Response Rate Difference|-13.6||||0.0377|2-Sided|95.0|-24.8|-2.4|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >=2.6 to <=3.2), baseline weight-by-dosing group (<80 kg q2w, <80 kg qw, 80-<100 kg q2w, 80-<100 kg qw, >=100 kg qw), participant anti-TNF exposure (Yes/No).|
1643130|NCT01855789|3020555|Superiority||ACR 20 Response Rate Difference|-8.2|||||2-Sided|95.0|-15.8|-0.6|||||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 24|
1643131|NCT01855789|3020555|Superiority||ACR 20 Response Rate Difference|-8.8||||0.1159|2-Sided|95.0|-19.3|1.6|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 52: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >=2.6 to <=3.2), baseline weight-by-dosing group (<80 kg q2w, <80 kg qw, 80-<100 kg q2w, 80-<100 kg qw, >=100 kg qw), participant anti-TNF exposure (Yes/No).|
1643132|NCT01855789|3020555|Superiority||ACR 20 Response Rate Difference|-10.2||||0.0746|2-Sided|95.0|-20.2|-0.2|||Cochran-Mantel-Haenszel||Observed difference in percentages (TCZ + PBO minus TCZ + MTX) and the asymptotic Wald 95% CI is presented.|Week 40: Analysis of association between treatment group and response, stratified by the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >=2.6 to <=3.2), baseline weight-by-dosing group (<80 kg q2w, <80 kg qw, 80-<100 kg q2w, 80-<100 kg qw, >=100 kg qw), participant anti-TNF exposure (Yes/No).|
1643133|NCT01855789|3020556|Non-Inferiority|Non-inferiority of TCZ + PBO was claimed if the upper bound of the 95% confidence interval (CI) for the mean difference was below 0.6.|Estimated Mean Difference|0.318|Standard Error of the Mean|0.139|||2-Sided|95.0|0.045|0.592||||||Analysis of covariance (ANCOVA) model included Week 24 DAS28 as a covariate, treatment group, and the randomization stratification factors: DAS28 remission status at Week 24 (<2.6, >/=2.6 to </=3.2), baseline weight-by-dosing group (<80 kg q2w, <80 kg qw, 80-<100 kg q2w, 80-<100 kg qw, >/=100 kg qw), participant anti-tumor necrosis factor (anti-TNF) exposure (Yes/No).|
1643134|NCT01855750|3020557|Superiority||Hazard Ratio (HR)|1.358||||0.0021|2-Sided|95.0|1.115|1.654|||Log Rank||||
1643135|NCT01855750|3020558|Superiority||Hazard Ratio (HR)|1.03||||0.8549|2-Sided|95.0|0.754|1.407|||Log Rank||||
1643136|NCT01855750|3020559|Superiority||Odds Ratio (OR)|0.967||||0.8229|2-Sided|95.0|0.722|1.296|||Cochran-Mantel-Haenszel (CMH) Chi‑square||||
1643137|NCT01855750|3020560|Superiority||Hazard Ratio (HR)|0.917||||0.5027|2-Sided|95.0|0.71|1.183|||Log Rank||||
1643138|NCT01855750|3020561|Superiority||Hazard Ratio (HR)|0.949||||0.7311|2-Sided|95.0|0.704|1.279|||Log Rank||||
1643140|NCT01854827|3020602|Superiority|One-sided for IVIG superior to historical START placebo control. PMID: 24794368 NCT00294684|Risk Difference (RD)|-11.9|||||1-Sided|90.0||2.1||||||K-M estimates for survival for IVIG vs the historical START placebo control are provided, along with one-sided 90% upper bounds of the confidence intervals.|
1643141|NCT01854827|3020603|Superiority|One-sided.|Odds Ratio (OR)|0.29||||0.8431|1-Sided|90.0||1.24||One-sided|Regression, Logistic|||IVIG was compared for superiority to the historical START placebo control (N=64).|
1643142|NCT01854827|3020604|Superiority|One-sided testing for superiority of IVIG relative to historical control.|Odds Ratio (OR)|0.33||||0.8455|1-Sided|90.0||1.22|||Regression, Logistic|||IVIG was compared for superiority to the historical control of START study placebo (N=64). PMID: 24794368 NCT00294684|
1643143|NCT01854827|3020605|Superiority|One-sided testing for superiority of IVIG to historical control.|Odds Ratio (OR)|0.67||||0.5486|1-Sided|90.0||2.38|||Regression, Logistic|||IVIG was compared to the historical placebo control from the START study (n=64): PMID: 24794368 NCT00294684|
1643144|NCT01854827|3020606|Other|Percent of patients with other expected AEs are presented along with one-sided 90% Clopper-Pearson confidence limit lower bound.|Percent of patients|27.6|||||1-Sided|90.0|14.5||||||||
1643145|NCT01854827|3020607|Other|Percent of patients with level 3-5 toxicity are presented along with one-sided 90% Clopper-Pearson confidence interval lower bound.|Percent of patients|89.7|||||1-Sided|90.0|75.4||||||||
1643146|NCT01854827|3020608|Other|Percents with serious AEs prior to liver transplant were calculated, along with one-sided 90% Clopper-Pearson confidence interval lower bounds.|Percent of patients|89.7|||||1-Sided|90.0|75.4||||||||
1643147|NCT01854827|3020609|Superiority|Percent was evaluated relative to 80% where statistical superiority was demonstrated if the one-sided, 90% Clopper-Pearson lower confidence bound was > 80%.|Percent of patients|79.3|||||1-Sided|90.0|63.2||||||||The lower bound of the 90% Clopper-Pearson confidence interval was < 80%, therefore the study failed to achieve the feasibility definition stated in the protocol.
1643148|NCT01854827|3020610|Superiority|Percent was evaluated relative to 80% where statistical superiority was demonstrated if the one-sided, 90% Clopper-Pearson lower confidence bound was > 80%.|Percent of patients|79.3|||||1-Sided|90.0|63.2||||||||The lower bound of the 90% Clopper-Pearson confidence interval was < 80%, therefore the study failed to achieve the feasibility definition stated in the protocol.
1643149|NCT01854697|3020618|Non-Inferiority or Equivalence|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.5|||||2-Sided|95.0|6.4|32.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.||
1643150|NCT01854697|3020618|Non-Inferiority or Equivalence|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|19.6|||||2-Sided|95.0|6.5|32.7|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.||
1643151|NCT01854697|3020618|Non-Inferiority or Equivalence|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1a HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|13.3|||||2-Sided|95.0|-0.4|27.0|||||Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.||
1643152|NCT01854697|3020621|Superiority or Other|||||||0.005|||||||Cochran-Mantel-Haenszel|Stratum-adjusted Cochran-Mantel-Haenszel after adjusting for IL28B genotype (CC or non-CC).|||
1643153|NCT01854697|3020621|Superiority or Other||Odds Ratio (OR)|28.2||||0.002|2-Sided|95.0|3.3|241.1|||Regression, Logistic|Calculated using logistic regression model with treatment arm, baseline log10 HCV RNA level, and IL28B genotype (CC versus non-CC) as predictors.|||
1643154|NCT01854697|3020621|Non-Inferiority or Equivalence|The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.|Difference|20.8|||||2-Sided|95.0|7.9|33.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.||
1643155|NCT01854697|3020621|Superiority or Other||Odds Ratio (OR)|7.2||||0.021|2-Sided|95.0|1.4|38.0|||Regression, Logistic|Logistic regression model with treatment arm, baseline log10 HCV RNA level, and interleukin 28B (IL28B) genotype (CC versus non-CC) as predictors.|||
1643156|NCT01854697|3020622|Superiority or Other||Least Squares Mean Difference|6.86|Standard Error of the Mean|1.27|<|0.001|2-Sided|95.0|4.36|9.37|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.|||
1643157|NCT01854697|3020622|Superiority or Other||Least Squares Mean Difference|6.2|Standard Error of the Mean|1.34|<|0.001|2-Sided|95.0|3.55|8.85|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.|||
1643158|NCT01854697|3020622|Superiority or Other||Least Squares Mean Difference|6.08|Standard Error of the Mean|1.69|<|0.001|2-Sided|95.0|2.72|9.44|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.|||
1643159|NCT01854697|3020623|Superiority or Other||Least Squares Mean of Difference|5.28|Standard Error of the Mean|1.65||0.002|2-Sided|95.0|2.01|8.54|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.|||
1643160|NCT01854697|3020623|Superiority or Other||Least Squares Mean of Difference|5.83|Standard Error of the Mean|1.84||0.002|2-Sided|95.0|2.19|9.47|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.|||
1643161|NCT01854697|3020623|Superiority or Other||Least Squares Mean Difference|2.13|Standard Error of the Mean|2.28||0.351|2-Sided|95.0|-2.39|6.65|||ANCOVA|ANCOVA model included baseline score and region as covariates and treatment arm as a factor.|||
1643201|NCT01854047|3020700|Superiority||LS Mean Difference|0.17||||0.0212|2-Sided|95.0|0.03|0.32||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q4w vs. Placebo q2w||
1643202|NCT01854047|3020700|Superiority||LS Mean Difference|0.26||||0.0008|2-Sided|95.0|0.11|0.4||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q2w vs. Placebo q2w||
1644506|NCT01816594|3024418|Superiority|||||||0.286|||||||Fisher Exact|(one-sided)||All participants|
1643162|NCT01854697|3020624|Non-Inferiority or Equivalence|The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of –10.5%.|Difference|19.5|||||2-Sided|95.0|6.4|32.6|||||Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.||
1643163|NCT01854697|3020624|Non-Inferiority or Equivalence|The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of –10.5%.|Difference|14.7|||||2-Sided|95.0|1.3|28.2|||||Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.||
1643164|NCT01854658|3020625|Superiority or Other||||||<|0.0001|||||||ANCOVA|||At 15 min post dose|
1643165|NCT01854658|3020625|Superiority or Other||||||<|0.0001|||||||ANCOVA|||At 5 min post dose|
1643166|NCT01854658|3020625|Superiority or Other||||||<|0.0001|||||||ANCOVA|||At 15 min post dose|
1643167|NCT01854658|3020625|Superiority or Other||||||<|0.0001|||||||ANCOVA|||At 5 min post dose|
1643168|NCT01854658|3020625|Superiority or Other||||||<|0.0001|||||||ANCOVA|||At 15 min post dose|
1643169|NCT01854658|3020625|Superiority or Other||||||<|0.0001|||||||ANCOVA|||At 5 min post dose|
1643170|NCT01854645|3020632|Superiority or Other||||||<|0.0001|||||||ANCOVA|||At 15 min post dose|
1643171|NCT01854645|3020632|Superiority or Other||||||<|0.0001|||||||ANCOVA|||At 5 min post dose|
1643172|NCT01854645|3020632|Superiority or Other||||||<|0.0001|||||||ANCOVA|||At 15 min post dose|
1643173|NCT01854645|3020632|Superiority or Other||||||<|0.0001|||||||ANCOVA|||At 5 min post dose|
1643174|NCT01854645|3020632|Superiority or Other||||||<|0.0001|||||||ANCOVA|||At 15 min post dose|
1643175|NCT01854645|3020632|Superiority or Other||||||<|0.0001|||||||ANCOVA|||At 5 min post dose|
1643176|NCT01854632|3020647|Superiority or Other|||||||0.996|||||||Log Rank||||
1643177|NCT01854593|3020648|Superiority or Other|||||||0.378|||||||Chi-squared||||
1643178|NCT01854593|3020649|Superiority or Other|||||||0.67|||||||Fisher Exact||||
1643179|NCT01854593|3020650|Superiority or Other|||||||0.149|||||||Fisher Exact||||
1643180|NCT01854593|3020651|Superiority or Other|||||||0.131|||||||Chi-squared||||
1643181|NCT01854593|3020652|Superiority or Other|||||||0.445|||||||Wilcoxon (Mann-Whitney)||||
1643182|NCT01854593|3020653|Superiority or Other|||||||0.929|||||||Wilcoxon (Mann-Whitney)||||
1643183|NCT01854593|3020654|Superiority or Other|||||||0.298|||||||Wilcoxon (Mann-Whitney)||||
1643184|NCT01854593|3020655|Superiority or Other|||||||0.593|||||||Fisher Exact||||
1643185|NCT01854593|3020656|Superiority or Other|||||||0.667|||||||Wilcoxon (Mann-Whitney)||||
1643186|NCT01854593|3020657|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1643187|NCT01854593|3020658|Superiority or Other|||||||0.033|||||||Fisher Exact||||
1643188|NCT01854593|3020659|Superiority or Other|||||||0.006|||||||Chi-squared||||
1643189|NCT01854593|3020660|Superiority or Other|||||||0.025|||||||Wilcoxon (Mann-Whitney)||||
1643190|NCT01854528|3020663|Superiority or Other||Odds Ratio (OR)|54.7|||<|0.001|2-Sided|95.0|6.9|435.1|||Regression, Logistic|||P-value from logistic regression model including treatment arm, baseline log10 HCV RNA level, HCV subgenotype, and previous response to pegIFN/RBV treatment as predictors.|
1643191|NCT01854528|3020664|Superiority or Other||LS mean difference|7.55|||<|0.001|2-Sided|95.0|5.11|9.98|||ANCOVA|||P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.|
1643192|NCT01854528|3020665|Superiority or Other||LS mean difference|8.64|||<|0.001|2-Sided|95.0|5.43|11.85|||ANCOVA|||P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.|
1643193|NCT01854528|3020666|Superiority or Other||Mean Difference (Final Values)|34.26|||<|0.001|2-Sided|95.0|21.09|47.42|||Stratum adjusted Mantel-Haenszel|||P-value for the difference in sustained virologic response rates 12 weeks after the last dose between treatment groups with HCV subgenotype (1a, non-1a) from stratum adjusted Mantel-Haenszel with previous type of response to pegIFN/RBV treatment (relapser, partial or null responder) as strata.|
1643194|NCT01854281|3020667|Superiority or Other||||||<|0.01|||||||Fisher Exact|||null hypothesis: there is no difference in the occurence of arterial bubbles after simulated dive between closure and PFO groups.|
1643195|NCT01854281|3020667|Superiority or Other||||||<|0.02|||||||Fisher Exact|||null hypothesis: there is no difference in the occurence of arterial bubbles after simulated dive between closure and PFO groups.|
1643196|NCT01854047|3020699|Superiority||LS Mean Difference|0.1||||0.0304|2-Sided|95.0|0.01|0.18||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q4w vs. Placebo q2w||
1643197|NCT01854047|3020699|Superiority||LS Mean Difference|0.12||||0.0048|2-Sided|95.0|0.04|0.21||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q4w vs. Placebo q2w||
1643198|NCT01854047|3020699|Superiority||LS Mean Difference|0.2|||<|0.0001|2-Sided|95.0|0.011|0.28||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q2w vs. Placebo q2w||
1643199|NCT01854047|3020699|Superiority||LS Mean Difference|0.16|||<|0.0002|2-Sided|95.0|0.08|0.25||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q2w vs. Placebo q2w|Analysis was performed using MMRM approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w and 200 mg q4w.|
1643200|NCT01854047|3020700|Superiority||LS Mean Difference|0.08||||0.2774|2-Sided|95.0|-0.07|0.23||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 200 mg q4w vs. Placebo q2w||
1643251|NCT01852955|3020870|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)||||
1643203|NCT01854047|3020700|Superiority||Least Square (LS) Mean Difference|0.21||||0.0063|2-Sided|95.0|0.06|0.36||Threshold for significance at 0.05.|Mixed Models Analysis||Dupilumab 300 mg q2w vs. Placebo q2w|Analysis was performed using mixed effect model with repeated measures (MMRM) approach including available FEV1 data from baseline to Week 12 and treatment group as a factor. A step-down procedure was used to strongly control the overall type I error rate for testing multiple doses against placebo. The hierarchy was 300 mg q2w, 200 mg q2w, 300 mg q4w, and 200 mg q4w.|
1643204|NCT01853930|3020706|Superiority|The purpose of the superiority test is to show if laboratory based training is superior to an independent home-based training option.||||||0.876|||||||t-test, 2 sided|t= -0.157 df= 30|||
1643205|NCT01853878|3020716|Equivalence|P-value of the Wald test from a Cox regression model to test H0 = { HR=1} (Y = Time to Event)|Hazard Ratio (HR)|4.592||||0.1422|2-Sided|95.0|0.6|35.167|||Regression, Cox|||Estimates of Hazard Ratio (HR) and their 95% Confidence Interval (CI) were obtained by Cox regression modelling.The Likelihood ratio test was used to compare the groups. The Cox proportional hazard regression was stratified by previous treatment [Chemotherapy (CT) vs. no-CT] and disease stage.|
1643206|NCT01853384|3020791|Superiority or Other|||||||0.3369||||||Week 12|ANCOVA||||
1643207|NCT01853384|3020791|Superiority or Other|||||||0.601||||||Week 11|ANCOVA||||
1643208|NCT01853384|3020791|Superiority or Other|||||||0.4661||||||Week 10|ANCOVA||||
1643209|NCT01853384|3020791|Superiority or Other|||||||0.0973||||||Week 09|ANCOVA||||
1643210|NCT01853384|3020791|Superiority or Other|||||||0.0161||||||Week 08|ANCOVA||||
1643211|NCT01853384|3020791|Superiority or Other|||||||0.0682||||||Week 07|ANCOVA||||
1643212|NCT01853384|3020791|Superiority or Other|||||||0.1427||||||Week 06|ANCOVA||||
1643213|NCT01853384|3020791|Superiority or Other|||||||0.6497||||||Week 05|ANCOVA||||
1643214|NCT01853384|3020791|Superiority or Other|||||||0.5739||||||Week 04|ANCOVA||||
1643215|NCT01853384|3020791|Superiority or Other|||||||0.0867||||||Week 03|ANCOVA||||
1643216|NCT01853384|3020791|Superiority or Other|||||||0.6992||||||Week 02|ANCOVA||||
1643217|NCT01853384|3020791|Superiority or Other|||||||0.7439||||||Week 01|ANCOVA||||
1643218|NCT01853384|3020792|Superiority or Other|||||||0.9733||||||Week 12|ANCOVA||||
1643219|NCT01853384|3020792|Superiority or Other|||||||0.9114||||||Week 11|ANCOVA||||
1643220|NCT01853384|3020792|Superiority or Other|||||||0.8166||||||Week10|ANCOVA||||
1643221|NCT01853384|3020792|Superiority or Other|||||||0.4216||||||Week 09|ANCOVA||||
1643222|NCT01853384|3020792|Superiority or Other|||||||0.1566||||||Week 08|ANCOVA||||
1643223|NCT01853384|3020792|Superiority or Other|||||||0.6095||||||Week 07|ANCOVA||||
1643224|NCT01853384|3020792|Superiority or Other|||||||0.2888||||||Week 06|ANCOVA||||
1643225|NCT01853384|3020792|Superiority or Other|||||||0.1064||||||Week 05|ANCOVA||||
1643226|NCT01853384|3020792|Superiority or Other|||||||0.3487||||||Week 04|ANCOVA||||
1643227|NCT01853384|3020792|Superiority or Other|||||||0.1556||||||Week 03|ANCOVA||||
1643228|NCT01853384|3020792|Superiority or Other|||||||0.8234||||||Week 02|ANCOVA||||
1643229|NCT01853384|3020792|Superiority or Other|||||||0.5909||||||Week 01|ANCOVA||||
1643230|NCT01853384|3020794|Superiority or Other|||||||0.5348||||||Week 12 - Primary Endpoint|Cochran-Mantel-Haenszel||||
1643231|NCT01853384|3020794|Superiority or Other|||||||0.3722||||||Treatment Week 12|Cochran-Mantel-Haenszel||||
1643232|NCT01853384|3020794|Superiority or Other|||||||0.2821||||||Treatment Week 11|Cochran-Mantel-Haenszel||||
1643233|NCT01853384|3020794|Superiority or Other|||||||0.3516||||||Treatment Week 10|Cochran-Mantel-Haenszel||||
1643234|NCT01853384|3020794|Superiority or Other|||||||0.4405||||||Treatment Week 09|Cochran-Mantel-Haenszel||||
1643235|NCT01853384|3020794|Superiority or Other|||||||0.7232||||||Treatment Week 08|Cochran-Mantel-Haenszel||||
1643236|NCT01853384|3020794|Superiority or Other|||||||0.2611||||||Treatment Week 07|Cochran-Mantel-Haenszel||||
1643237|NCT01853384|3020794|Superiority or Other|||||||0.1617||||||Treatment Week 06|Cochran-Mantel-Haenszel||||
1643238|NCT01853384|3020794|Superiority or Other|||||||0.1997||||||Treatment Week 05|Cochran-Mantel-Haenszel||||
1643239|NCT01853384|3020794|Superiority or Other|||||||0.5263||||||Treatment Week 04|Cochran-Mantel-Haenszel||||
1643240|NCT01853384|3020794|Superiority or Other|||||||0.3362||||||Treatment Week 03|Cochran-Mantel-Haenszel||||
1643241|NCT01853384|3020794|Superiority or Other|||||||0.793||||||Treatment Week 02|Cochran-Mantel-Haenszel||||
1643242|NCT01853384|3020794|Superiority or Other|||||||0.6194||||||Treatment Week 01|Cochran-Mantel-Haenszel||||
1643243|NCT01853384|3020796|Superiority or Other|||||||0.9456|||||||Regression, Cox||||
1643244|NCT01853384|3020797|Superiority or Other|||||||0.5348||||||Analysis adjusted for sites, with significance being at P < 0.05|Cochran-Mantel-Haenszel||||
1643245|NCT01853072|3020843|Superiority or Other||Odds Ratio (OR)|0.1|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|0.1|0.3|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for EU registration and secondary for US registration.|
1643246|NCT01853072|3020844|Superiority or Other||Odds Ratio (OR)|2.1|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|1.5|3.0|||Regression, Logistic||Parameter dispersion is the standard error for the odds ratio.|This endpoint was considered primary for United States (US) registration and secondary for European Union (EU) registration.|
1643247|NCT01853046|3020868|Superiority or Other||LS-means|0.446|||||2-Sided|90.0|0.2|0.996||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of metabolites M-5 calculated by re-transformation of the logarithmic data from ANOVAs|
1643248|NCT01853046|3020868|Superiority or Other||LS-means|0.684|||||2-Sided|90.0|0.397|1.18||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of metabolites M-2 calculated by re-transformation of the logarithmic data from ANOVAs.|
1643249|NCT01853046|3020868|Superiority or Other||LS Mean|1.14|||||2-Sided|90.0|0.796|1.63||||||Point estimates (LS-means) and 2-sided exploratory 90% confidence intervals for AUC(0-tlast) of regorafenib calculated by re-transformation of the logarithmic data from ANOVAs.|
1643250|NCT01852955|3020869|Superiority or Other|||||||0.36|||||||Wilcoxon (Mann-Whitney)||||
1643253|NCT01852825|3020872|Superiority or Other||Mean Difference (Final Values)|-61.115||||0.014|2-Sided|90.0|-100.185|-22.045|||Constrained Longitudinal Data Analysis||MK-8237 treatment minus Placebo treatment||
1643254|NCT01852825|3020873|Superiority or Other||Geometric Mean Ratio|2.21||||0.296|2-Sided|90.0|0.605|8.066|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment||
1643255|NCT01852825|3020874|Superiority or Other||Geometric Mean Ratio|1.068||||0.935|2-Sided|90.0|0.272|4.19|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment||
1643256|NCT01852825|3020875|Superiority or Other||Mean Difference (Final Values)|0.238||||0.027|2-Sided|90.0|0.066|0.41|||Constrained Longitudinal Data Analysis||MK-8237 treatment minus Placebo treatment|The hypothesis is supported if the lower bound of the 1-tailed 95% CI around the mean difference in change from baseline excludes zero|
1643257|NCT01852825|3020876|Superiority or Other||Geometric Mean Ratio|2.182||||0.01|2-Sided|90.0|1.364|3.49|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|The hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the Week 12 geometric mean fold difference is >1.0.|
1643258|NCT01852825|3020877|Superiority or Other||Geometric Mean Ratio|2.355||||0.003|2-Sided|90.0|1.515|3.661|||Constrained Longitudinal Data Analysis||MK-8237 treatment divided by Placebo treatment|The hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the Week 12 geometric mean fold difference is >1.0.|
1643259|NCT01852799|3020889|Other||||||<|0.001|||||||t-test, 2 sided|||DKK-1 changes from baseline to cycle 4|
1643260|NCT01852799|3020889|Other||||||<|0.005|||||||Wilcoxon (Mann-Whitney)|||DKK-1 changes from baseline to cycle 1|
1643261|NCT01852799|3020889|Other||||||<|0.001|||||||t-test, 2 sided|||b-ALP changes from baseline to cycle 4|
1643262|NCT01852799|3020889|Other||||||<|0.002|||||||Wilcoxon (Mann-Whitney)|||bALP changes from baseline to cycle 1|
1643263|NCT01852383|3020895|Superiority or Other||||||<|0.001||||||Pearson correlation coefficient. Not adjusted for multiple comparisons. Alpha=0.05 for statistical significance threshold.|Pearson correlation|||Correlation of maximum duloxetine dose with change in Hamilton Depression Rating Scale scores from 0 Weeks to 12 Weeks.|
1643264|NCT01852383|3020896|Superiority or Other||||||<|0.001||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|ANCOVA||||
1643265|NCT01852383|3020897|Superiority or Other||||||<|0.1||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|Corrlation||||
1643266|NCT01852383|3020898|Superiority or Other||||||<|0.001||||||Change from Week 0 to Week 12, not adjusted for multiple comparisons. Alpha=0.05 threshold for statistical significance.|ANCOVA||||
1643267|NCT01852344|3020899|Superiority|||||||0.032|||||||t-test, 2 sided||||
1643268|NCT01852344|3020900|Superiority|||||||0.236|||||||t-test, 2 sided||||
1643269|NCT01852344|3020901|Superiority|||||||0.159|||||||t-test, 2 sided||||
1643270|NCT01852344|3020901|Superiority|||||||0.159|||||||t-test, 2 sided||||
1643271|NCT01852292|3020912|Other|Double criteria for OS|Cox Proportional Hazard|0.72|||||2-Sided|95.0|0.49|1.04|||||||
1643272|NCT01852292|3020913|Other|Double Criteria for PFS|Cox Proportional Hazard|0.646|||||2-Sided|95.0|0.44|0.94|||||||
1643273|NCT01852214|3020916|Superiority or Other|||||||0.086|||||||Mixed Models Analysis||||
1643274|NCT01852214|3020917|Superiority or Other|||||||0.022|||||||Mixed Models Analysis||||
1643275|NCT01852162|3020934|Superiority or Other||||||<|0.05||||||An analysis of covariance (ANCOVA) method with a general linear model, using the corresponding baseline PD value as a covariate, was used to evaluate the comparisons between dabigatran and placebo at 7 days.|ANCOVA|||Assuming a 20% relative difference in TRAP induced MPA between dabigatran and placebo with a common standard deviation of 10%, 13 patients with available data needed to be randomized to obtain a 95% power and 2-sided alpha=0.05.|
1643276|NCT01852110|3020936|Superiority or Other||Mean Difference (Final Values)|0.1||||0.0829|2-Sided|95.0|-0.01|0.22|||Constrained Longitudinal Data Analysis||||
1643277|NCT01852110|3020937|Superiority or Other||Mean Difference (Final Values)|0.06||||0.9604|2-Sided|95.0|-2.42|2.54|||Constrained Longitudinal Data Analysis||||
1643278|NCT01852110|3020941|Superiority or Other||Mean Difference (Final Values)|0.18||||0.7623|2-Sided|95.0|-1.0|1.37|||Constrained Longitudinal Data Analysis||||
1643279|NCT01852045|3020963|Superiority||Least Squares Mean Difference|-14.43|Standard Error of the Mean|5.85||0.0157|2-Sided|95.0|-26.061|-2.793|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.||
1643280|NCT01852045|3020963|Superiority||Least Squares Mean Difference|-7.21|Standard Error of the Mean|5.253||0.1737|2-Sided|95.0|-17.653|3.238|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.||
1643281|NCT01852045|3020964|Superiority||Least Squares Mean Difference|2.18|Standard Error of the Mean|10.181||0.8313|2-Sided|95.0|-18.427|22.795|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.||
1643282|NCT01852045|3020964|Superiority||Least Squares Mean Difference|-4.49|Standard Error of the Mean|7.488||0.5524|2-Sided|95.0|-19.648|10.669|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.||
1643283|NCT01852045|3020965|Superiority||Relative Risk|0.8||||0.1564|2-Sided|95.0|0.4|1.21||P-values for pairwise comparisons are obtained from a 2-sided CMH test, stratified by age (< 12 years or >= 12 years), baseline daytime urinary incontinence episodes (<= 6 or > 6) and anticholinergic therapy (yes/no).|Cochran-Mantel-Haenszel|||Week 6|
1643284|NCT01852045|3020965|Superiority||Relative Risk|0.7||||0.2027|2-Sided|95.0|0.45|1.14||P-values for pairwise comparisons are obtained from 2-sided CMH test, stratified by age (<12 years or >=12 years), baseline daytime urinary incontinence episodes (<=6 or >6) and anticholinergic therapy (yes/no).|Cochran-Mantel-Haenszel|||Week 6|
1643285|NCT01852045|3020966|Superiority||Least Squares Mean Difference|1.49|Standard Error of the Mean|22.382||0.9471|2-Sided|95.0|-43.012|45.991|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.||
1643286|NCT01852045|3020966|Superiority||Least Squares Mean Difference|-13.49|Standard Error of the Mean|19.673||0.4948|2-Sided|95.0|-52.605|25.626|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.||
1643287|NCT01852045|3020968|Superiority||Least Squares Mean Difference|65.57|Standard Error of the Mean|23.101||0.0055|2-Sided|95.0|19.711|111.421|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.||
1643288|NCT01852045|3020968|Superiority||Least Squares Mean Difference|12.97|Standard Error of the Mean|19.694||0.5117|2-Sided|95.0|-26.12|52.064|||ANCOVA||Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.||
1643289|NCT01852045|3020970|Superiority||Least Squares Mean Difference|-0.04|Standard Error of the Mean|0.321||0.9123|2-Sided|95.0|-0.673|0.602|||ANCOVA||Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.||
1643290|NCT01852045|3020970|Superiority||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.276||0.9949|2-Sided|95.0|-0.549|0.545|||ANCOVA||Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.||
1643291|NCT01851876|3020981|Superiority or Other|||||||0.025|||||||Fisher Exact||||
1643292|NCT01851590|3020998|Superiority or Other||||||<|0.05||||||Qualitative data are expressed as frequencies and percentages, and differences between parallel groups were compared with the χ2-test or Fisher’s exact test, as appropriate.|Chi-squared||||
1643293|NCT01851590|3020999|Superiority or Other||||||<|0.05||||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni’s post hoc test.|ANOVA||||
1643294|NCT01851590|3021000|Superiority or Other||||||<|0.05||||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni’s post hoc test.|ANOVA||||
1643295|NCT01851590|3021001|Superiority or Other||||||<|0.05||||||Differences between quantitative data were assessed with one-way analysis of variances, and pairwise comparisons were performed with Bonferroni’s post hoc test.|ANOVA||||
1643296|NCT01851590|3021002|Superiority or Other||||||<|0.05||||||Proportions and 95% confidence intervals (CIs) were calculated for negative KOH staining, negative cultures, and a combination of these at 4- and 10-month time points. Cochran–Mantel–Haenszel and χ2-tests were used to analyse efficacy criteria.|Cochran-Mantel-Haenszel|||The sample size was estimated according to complete mycological cure at 10 months. Estimation was based on the design of a binary-outcome head-to-head superiority trial. Orally administered terbinafine treatment was considered the active control. Approximately 25 patients / arm were required to have 80% power (β=0.2) at a two-sided α=0.05 significance level to detect a decrease in primary outcome from 50% in the terbinafine arm to 15% in the amorolfine or resin lacquer treatment arms.|
1643297|NCT01851330|3021012|Non-Inferiority or Equivalence|Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.|Difference in proportions|0.9|||||2-Sided|95.0|-3.9|5.7|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.||
1643298|NCT01851330|3021012|Non-Inferiority or Equivalence|Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.|Difference in proportions|-2.3|||||2-Sided|97.5|-7.2|2.5|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.||
1643299|NCT01851330|3021012|Non-Inferiority or Equivalence|Noninferiority would be demonstrated if the lower bound of the confidence interval (CI) for the difference between groups was greater than -12%.|Difference in proportions|-3.2|||||2-Sided|97.5|-8.3|1.8|||||Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.||
1643300|NCT01851330|3021012|Superiority or Other||||||<|0.001||||||The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test||||
1643301|NCT01851330|3021012|Superiority or Other||||||<|0.001||||||The p-value for the comparison of the LDV/SOF+RBV 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test||||
1643302|NCT01851330|3021012|Superiority or Other||||||<|0.001||||||The p-value for the comparison of the LDV/SOF 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test||||
1643303|NCT01850615|3021031|Superiority or Other||Treatment difference|-0.94|||||2-Sided|95.0|-1.17|-0.72|||||Superiority was considered confirmed if the upper bound of the two-sided 95% confidence interval (CI) for the estimated treatment difference (faster aspart+basal minus basal only), which was calculated using the FAS, was below 0%.|Change from baseline in HbA1c after 18 weeks of treatment was analysed using a mixed-effect model for repeated measurements (MMRM) where all calculated changes in HbA1c from baseline at visits 16, 22 and 28 were included in the analysis. This model included treatment, region and strata as fixed factors, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.|
1643304|NCT01850602|3021035|Non-Inferiority|"Non-Inferiority margin: 1.0 mg/dL~Non-Inferiority was considerd to be confirmed if the upper limit of two-sided confidence interval became 1.0 mg/dL or less."|Mean Difference (Final Values)|-0.34||||0.02|2-Sided|95.0|-0.63|-0.05|||ANCOVA||||
1643305|NCT01850446|3021049|Superiority|||||||0.841|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD19+CD3-)|
1643306|NCT01850446|3021049|Superiority|||||||0.943|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD19+CD3-)|
1643307|NCT01850446|3021049|Superiority|||||||0.821|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3-CD8+)|
1643308|NCT01850446|3021049|Superiority|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3-CD8+)|
1643309|NCT01850446|3021049|Superiority||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3-CD16+CD56+)|
1643310|NCT01850446|3021049|Superiority||||||>|0.31|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3-CD16+CD56+)|
1643311|NCT01850446|3021049|Superiority||||||>|0.821|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD16+CD56+)|
1643312|NCT01850446|3021049|Superiority||||||>|0.148|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD16+CD56+)|
1643313|NCT01850446|3021049|Superiority||||||>|0.904|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD8+)|
1643314|NCT01850446|3021049|Superiority||||||>|0.172|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD8+)|
1643315|NCT01850446|3021049|Superiority||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+CD4+)|
1643316|NCT01850446|3021049|Superiority||||||>|0.418|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+CD4+)|
1643317|NCT01850446|3021049|Superiority||||||>|0.699|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of CD3+)|
1643318|NCT01850446|3021049|Superiority||||||>|0.361|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of CD3+)|
1643319|NCT01850446|3021049|Superiority||||||>|0.031|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of basophils)|
1643320|NCT01850446|3021049|Superiority||||||>|0.268|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of basophils)|
1643321|NCT01850446|3021049|Superiority||||||>|0.666|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of eosinophils)|
1643322|NCT01850446|3021049|Superiority||||||>|0.424|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of eosinophils)|
1643323|NCT01850446|3021049|Superiority||||||>|0.019|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of monocytes)|
1643324|NCT01850446|3021049|Superiority||||||>|0.017|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of monocytes)|
1643325|NCT01850446|3021049|Superiority||||||>|0.58|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of lymphocytes)|
1643326|NCT01850446|3021049|Superiority||||||>|0.45|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of lymphocytes)|
1643327|NCT01850446|3021049|Superiority||||||>|0.071|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (RC of neutrophils)|
1643328|NCT01850446|3021049|Superiority||||||>|0.282|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (RC of neutrophils)|
1643329|NCT01850446|3021050|Superiority|||||||0.736|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD119+)|
1643330|NCT01850446|3021050|Superiority|||||||0.473|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD119+)|
1643331|NCT01850446|3021050|Superiority|||||||0.967|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD19+CD3-)|
1643332|NCT01850446|3021050|Superiority|||||||0.837|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD19+CD3-)|
1643333|NCT01850446|3021050|Superiority|||||||0.554|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3-CD8+)|
1643334|NCT01850446|3021050|Superiority|||||||0.727|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3-CD8+)|
1643335|NCT01850446|3021050|Superiority|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3-CD16+CD56+)|
1643336|NCT01850446|3021050|Superiority|||||||0.472|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3-CD16+CD56+)|
1643337|NCT01850446|3021050|Superiority|||||||0.573|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD16+CD56+)|
1643338|NCT01850446|3021050|Superiority|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD16+CD56+)|
1643339|NCT01850446|3021050|Superiority|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD8+)|
1643340|NCT01850446|3021050|Superiority|||||||0.335|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD8+)|
1643341|NCT01850446|3021050|Superiority|||||||0.945|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+CD4+)|
1643342|NCT01850446|3021050|Superiority|||||||0.466|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+CD4+)|
1643343|NCT01850446|3021050|Superiority|||||||0.783|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (CD3+)|
1643344|NCT01850446|3021050|Superiority|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (CD3+)|
1643345|NCT01850446|3021050|Superiority|||||||0.102|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (basophils)|
1643346|NCT01850446|3021050|Superiority|||||||0.242|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (basophils)|
1643347|NCT01850446|3021050|Superiority|||||||0.912|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (eosinophils)|
1643348|NCT01850446|3021050|Superiority|||||||0.575|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (eosinophils)|
1643349|NCT01850446|3021050|Superiority|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (lymphocytes)|
1643350|NCT01850446|3021050|Superiority|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (monocytes)|
1643351|NCT01850446|3021050|Superiority|||||||0.777|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (lymphocytes)|
1643352|NCT01850446|3021050|Superiority|||||||0.759|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (lymphocytes)|
1643353|NCT01850446|3021050|Superiority|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (neutrophils)|
1643354|NCT01850446|3021050|Superiority|||||||0.607|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day1 to day 3 (neutrophils)|
1643355|NCT01850446|3021050|Superiority|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (leukocytes)|
1643356|NCT01850446|3021050|Superiority|||||||0.364|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (leukocytes)|
1643357|NCT01850446|3021051|Superiority||||||>|0.99|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Induced IFN-γ)|
1643358|NCT01850446|3021051|Superiority||||||>|0.475|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Induced IFN-γ)|
1643359|NCT01850446|3021051|Superiority||||||>|0.356|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Spontaneous IFN-γ)|
1643360|NCT01850446|3021051|Superiority||||||>|0.592|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-γ)|
1643361|NCT01850446|3021051|Superiority||||||>|0.386|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (Induced IFN-α)|
1643362|NCT01850446|3021051|Superiority||||||>|0.204|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Induced IFN-α)|
1643363|NCT01850446|3021051|Superiority||||||>|0.404|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-α)|
1643364|NCT01850446|3021051|Superiority||||||>|0.065|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (Spontaneous IFN-α)|
1643365|NCT01850446|3021052|Superiority|||||||0.638|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IL-16)|
1643366|NCT01850446|3021052|Superiority|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IL-16)|
1643367|NCT01850446|3021052|Superiority||Median Difference (Final Values)|0.37||||0.08|2-Sided|95.0|-0.04|0.79|||t-test, 2 sided|||difference between changes from day 1 to day 7 (IL-4)|
1643368|NCT01850446|3021052|Superiority||Mean Difference (Final Values)|0.47||||0.04|2-Sided|95.0|0.02|0.92|||t-test, 2 sided|||difference between changes from day 1 to day 3 (IL-4)|
1643369|NCT01850446|3021052|Superiority|||||||0.992|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IL-18)|
1643370|NCT01850446|3021052|Superiority|||||||0.795|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IL-18)|
1643371|NCT01850446|3021052|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 7 (IFN-γ)|
1643372|NCT01850446|3021052|Superiority||||||<|0.012|||||||Wilcoxon (Mann-Whitney)|||difference between changes from day 1 to day 3 (IFN-γ)|
1643373|NCT01850446|3021052|Superiority||Mean Difference (Final Values)|1.23|||<|0.19|2-Sided|95.0|-0.64|3.12||P-value IL2 provided for between-group comparisson of difference from day 7 to day 1.|t-test, 2 sided|||difference between changes from day 1 to day 7 (IL-2)|
1643374|NCT01850446|3021052|Superiority||Mean Difference (Final Values)|1.89|||<|0.03|2-Sided|95.0|0.19|3.59||P-value IL2 provided for between-group comparisson of difference from days 3 to day 1.|t-test, 2 sided|||difference between changes from day 1 to day 3 (IL-2)|
1643375|NCT01850446|3021053|Non-Inferiority|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.03|||<|0.001|1-Sided|97.5||0.03|||Z test for proportions|||Proportion difference of Patients With Negative Results (day7)|
1643376|NCT01850446|3021053|Non-Inferiority|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.08|||<|0.037|1-Sided|97.5||0.03|||Z test for proportions|||Proportion difference of Patients With Negative Results (day5)|
1643377|NCT01850446|3021053|Non-Inferiority|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.01|||<|0.014|1-Sided|97.5||0.15|||Z test for proportions|||Proportion difference of Patients With Negative Results (day3)|
1643378|NCT01850446|3021054|Non-Inferiority|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.0|||<|0.001|1-Sided|97.5||0.03|||Z test for proportions|||Percentage of Patients Requiring Antibiotics Administration|
1643379|NCT01850446|3021055|Non-Inferiority|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.02|||<|0.001|1-Sided|97.5||0.01|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day5)|
1643380|NCT01850446|3021055|Non-Inferiority|N.I. margin was prespecified as 20%|Risk Difference (RD)|-0.02|||<|0.001|1-Sided|97.5||0.13|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day4)|
1643381|NCT01850446|3021055|Non-Inferiority|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.03|||<|0.001|1-Sided|97.5||0.13|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day3)|
1643382|NCT01850446|3021055|Non-Inferiority|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.01|||<|0.009|1-Sided|97.5||0.15|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day2)|
1643383|NCT01850446|3021055|Non-Inferiority|N.I. margin was prespecified as 20%|Risk Difference (RD)|0.05|||<|0.036|1-Sided|97.5||0.19|||Z test for proportions|||Percentage difference of Patients, Who Used Antipyretics (day1)|
1643384|NCT01850446|3021056|Non-Inferiority|N.I. margin was prespecified as 20% (AUC ratio supposed to be less than 1.2)|AUC ratio|1.04||||0.015|2-Sided|95.0|0.9|1.17||bootstrap (100000 rep) confidence limits were constructed for AUC ratio|one-sample Z-test|AUC ratio was compared with N.I. margin||Severity of influenza was measured as area under curve (symptoms score-time)|
1643385|NCT01850446|3021057|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.25|||<|0.001|1-Sided|97.5||0.11|||t-test, 1 sided|||Nasal/ throat/ chest symptoms duration|
1643386|NCT01850446|3021057|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.18|||<|0.001|1-Sided|97.5||0.14|||t-test, 1 sided|||Non-specific symptoms duration|
1643716|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|78.43|||||2-Sided|90.0|52.14|117.98||||||Buprenorphine|
1643387|NCT01850446|3021057|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.08|||<|0.02|1-Sided|97.5||0.5|||t-test, 1 sided|||Fever duration|
1643388|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|1.34||||0.305|1-Sided|97.5||3.11|||t-test, 1 sided|||Severity of influenza symptoms (day3 physician's objective examination)|
1643389|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.43|||<|0.001|1-Sided|97.5||1.41|||t-test, 1 sided|||Severity of influenza symptoms (day1 physician's objective examination)|
1643390|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.27|||<|0.087|1-Sided|97.5||0.77|||t-test, 1 sided|||Severity of influenza symptoms (day6 evening)|
1643391|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.29|||<|0.313|1-Sided|97.5||1.53|||t-test, 1 sided|||Severity of influenza symptoms (day5 evening)|
1643392|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.08|||<|0.042|1-Sided|97.5||1.4|||t-test, 1 sided|||Severity of influenza symptoms (day4 evening)|
1643393|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|1.34|||<|0.447|1-Sided|97.5||3.08|||t-test, 1 sided|||Severity of influenza symptoms (day3 evening)|
1643394|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.9|||<|0.05|1-Sided|97.5||2.94|||t-test, 1 sided|||Severity of influenza symptoms (day2 evening)|
1643395|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.64|||<|0.004|1-Sided|97.5||2.67|||t-test, 1 sided|||Severity of influenza symptoms (day1 evening)|
1643396|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.25|||<|0.135|1-Sided|97.5||0.74|||t-test, 1 sided|||severity of influenza symptoms (day1 morning)|
1643397|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.08|||<|0.13|1-Sided|97.5||0.98|||t-test, 1 sided|||Severity of influenza symptoms (day6 morning)|
1643398|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.27|||<|0.04|1-Sided|97.5||1.07|||t-test, 1 sided|||Severity of influenza symptoms (day5 morning)|
1643399|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.62|||<|0.22|1-Sided|97.5||2.2|||t-test, 1 sided|||Severity of influenza symptoms (day4 morning)|
1643400|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.82|||<|0.084|1-Sided|97.5||2.66|||t-test, 1 sided|||Severity of influenza symptoms (day3 morning)|
1643401|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|0.56|||<|0.013|1-Sided|97.5||2.59|||t-test, 1 sided|||Severity of influenza symptoms (day2 morning)|
1643402|NCT01850446|3021058|Non-Inferiority|N.I. margin was prespecified as 20% of comparator (with respect to timeframe)|Mean Difference (Final Values)|-0.49|||<|0.001|1-Sided|97.5||1.33|||t-test, 1 sided|||Severity of influenza symptoms (day1 morning)|
1643403|NCT01850446|3021059|Non-Inferiority|Non-inferiority margin was prespecified as 20% (on each day)|Z-value|6.95|||<|0.0001|2-Sided|||||Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics|
1643404|NCT01850446|3021060|Non-Inferiority|Non-inferiority magrin was prespecified as 20% of comparator duration|Mean Difference (Final Values)|0.23||||0.02|1-Sided|97.5||0.63|||t-test, 1 sided|mean survival time estimates obtained from survival analysis were compared by means of t-test with infinite degrees of freedom|||
1643405|NCT01850446|3021061|Non-Inferiority|Non-inferiority margin was prespecified as 1.2 degree*day|Mean Difference (Final Values)|0.44||||0.027|1-Sided|97.5|-0.23||||t-test, 1 sided|||Severity of fever was measured as area under curve (body temperature-time)|
1643406|NCT01850446|3021062|Non-Inferiority|Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectievely planned for this analysis. Power of this analysis was planned to be greater than 0.8|Z-value|7.31|||<|0.0001|2-Sided|||||Global test statistics (GTS) was constructed in accordance with O'Brien, P. (1984). Procedures for Comparing Samples with Multiple Endpoints. Biometrics, 40(4), 1079-1087. doi:10.2307/2531158|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics (physician’s examination analysis)|
1643407|NCT01850446|3021062|Non-Inferiority|Non-inferiority margin was prespecified as 20% (on each day). Type I error (alpha) level of 0.025 was prospectively planned for this analysis. Power of this analysis was planned to be greater than 0.8|Z-value|8.56|||<|0.0001|2-Sided|||||Global test statistics (GTS) was constructed in accordance with O'Brien Procedures for Comparing Samples with Multiple Endpoints.|Z-test for Global test statistics|||Individual day analyses were combined into Global Test Statistics (patient diary analysis)|
1643408|NCT01850394|3021063|Superiority or Other||Mean Difference (Net)|0.66|Standard Deviation|1.0||0.05|2-Sided|95.0|||||ANOVA||||
1643409|NCT01850394|3021064|Superiority or Other||Hazard Ratio (HR)|0.1|Standard Error of the Mean|0.02|<|0.05|2-Sided|95.0|||||Fisher Exact||||
1643410|NCT01850394|3021065|Superiority or Other||Hazard Ratio (HR)|0.25|Standard Error of the Mean|0.1|<|0.05|2-Sided|95.0|||||Fisher Exact||||
1643411|NCT01850394|3021066|Superiority or Other||Mean Difference (Final Values)|15.0|Standard Deviation|4.0|<|0.05|2-Sided|95.0|||||ANOVA||||
1643412|NCT01850394|3021066|Superiority or Other||Mean Difference (Final Values)|140.0|Standard Deviation|15.0|<|0.05|2-Sided|95.0|||||ANOVA||||
1643413|NCT01850394|3021067|Superiority or Other||Mean Difference (Net)|150.0|Standard Deviation|200.0|<|0.05|2-Sided|95.0|||||ANOVA||||
1643414|NCT01850394|3021067|Superiority or Other||Mean Difference (Net)|180.0|Standard Deviation|300.0|<|0.05|2-Sided|95.0|||||ANOVA||||
1643415|NCT01849770|3021092|Superiority or Other||Slope|-0.94|Standard Error of the Mean|1.42||0.51|2-Sided|95.0|-3.8|1.91|||Random slopes model||||
1643416|NCT01849770|3021092|Superiority or Other||Slope|1.71|Standard Error of the Mean|1.25||0.178|2-Sided|95.0|-0.8|4.22|||Random slopes model||||
1643417|NCT01849770|3021093|Superiority or Other||Slope|-0.19|Standard Error of the Mean|0.43||0.662|2-Sided|95.0|-1.04|0.66|||Random slopes model||||
1643418|NCT01849770|3021093|Superiority or Other||Slope|-0.23|Standard Error of the Mean|0.4||0.561|2-Sided|95.0|-1.03|0.56|||Random slopes model||||
1643419|NCT01849562|3021123|Superiority or Other||Risk Difference (RD)|70.0|||||2-Sided|95.0|24.2|93.6||||||Differences in proportions between Group 2 (sovaprevir 400 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.|
1643420|NCT01849562|3021123|Superiority or Other||Risk Difference (RD)|50.0|||||2-Sided|95.0|1.8|82.7||||||Differences in proportions between Group 1 (sovaprevir 200 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.|
1643421|NCT01849497|3021124|Superiority or Other||LS Mean Treatment Difference|-3.7|Standard Error of the Mean|3.38|||2-Sided|95.0|-10.38|2.99|||||||
1643422|NCT01849497|3021125|Superiority or Other||Treatment Difference|-6.8|||||2-Sided|95.0|-16.3|2.0|||||||
1643423|NCT01849458|3021128|Superiority or Other||Mean Difference (Final Values)|49.2|Standard Deviation|20.2||0.0001|2-Sided|95.0|43.2|55.2|||2-sided, paired t-test|||Difference from baseline (12M-Baseline)|
1643424|NCT01849458|3021129|Superiority or Other||Mean Difference (Final Values)|43.8|Standard Deviation|22.2||0.0001|2-Sided|95.0|37.4|50.1|||2-sided, paired t-test|||Difference from baseline (6M-Baseline)|
1643425|NCT01849458|3021130|Superiority or Other||Mean Difference (Final Values)|35.7|Standard Deviation|23.6||0.0001|2-Sided|95.0|28.7|42.7|||2-sided, paired t-test|||Difference from baseline (12M-Baseline)|
1643426|NCT01849458|3021131|Superiority or Other||Mean Difference (Final Values)|32.6|Standard Deviation|26.0||0.0001|2-Sided|95.0|25.2|40.0|||2-sided, paired t-test|||Difference from baseline (6M-Baseline)|
1643427|NCT01849172|3021194|Superiority|||||||0.05|||||||Mixed Models Analysis||||
1643428|NCT01849055|3021199|Superiority||Mean Difference (Final Values)|-2.51|||||2-Sided|90.0|-5.23|0.2||||||DBP|
1643429|NCT01849055|3021199|Superiority||Mean Difference (Final Values)|-1.49|||||2-Sided|90.0|-4.09|1.1||||||DBP|
1643430|NCT01849055|3021199|Superiority||Mean Difference (Final Values)|-0.95|||||2-Sided|90.0|-3.75|1.85||||||DBP|
1643431|NCT01849055|3021199|Superiority||Mean Difference (Final Values)|-1.11|||||2-Sided|90.0|-3.69|1.48||||||DBP|
1643432|NCT01849055|3021199|Superiority||Mean Difference (Final Values)|-0.38|||||2-Sided|90.0|-2.95|2.18||||||DBP|
1643433|NCT01849055|3021199|Superiority||Mean Difference (Final Values)|-3.84|||||2-Sided|90.0|-7.74|0.07||||||SBP|
1643434|NCT01849055|3021199|Superiority||Mean Difference (Final Values)|-1.53|||||2-Sided|90.0|-5.16|2.1||||||SBP|
1643435|NCT01849055|3021199|Superiority||Mean Difference (Final Values)|-1.54|||||2-Sided|90.0|-5.3|2.22||||||SBP|
1643436|NCT01849055|3021199|Superiority||Mean Difference (Final Values)|-1.09|||||2-Sided|90.0|-4.7|2.53||||||SBP|
1643437|NCT01849055|3021199|Superiority||Mean Difference (Final Values)|-1.22|||||2-Sided|90.0|-4.98|2.54||||||SBP|
1643438|NCT01848990|3021209|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.984|2-Sided|95.0|-1.5|1.6||DTSQc|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643439|NCT01848990|3021209|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.9081|2-Sided|95.0|-1.1|1.3||DTSQs|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643440|NCT01848990|3021210|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.9901|2-Sided|95.0|-0.3|0.3|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643441|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6869|2-Sided|95.0|-0.4|0.6||Freedom to drink|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643442|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.3144|2-Sided|95.0|-0.3|0.9||Freedom to eat|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643443|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.5||||0.1367|2-Sided|95.0|-1.1|0.2||Depend on others|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643444|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.89|2-Sided|95.0|-0.5|0.5||Living situation and conditions|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643445|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.8762|2-Sided|95.0|-0.5|0.6||Financial situation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643446|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.4||||0.2062|2-Sided|95.0|-1.0|0.2||Feelings about the future|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643447|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.2||||0.2175|2-Sided|95.0|-0.1|0.6||The way people in general react|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643448|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.3||||0.3444|2-Sided|95.0|-0.8|0.3||Motivation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643449|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.7907|2-Sided|95.0|-0.4|0.5||Self-confidence|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643450|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.2087|2-Sided|95.0|-0.2|0.7||Physical appearance|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643451|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.3||||0.3177|2-Sided|95.0|-0.3|0.8||Sex life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643452|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.9744|2-Sided|95.0|-0.6|0.6||Close personal relationship|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643453|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6478|2-Sided|95.0|-0.4|0.6||Friendships and social life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643454|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.6876|2-Sided|95.0|-0.4|0.6||Family life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643455|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.724|2-Sided|95.0|-0.4|0.6||Do physically|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643456|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.4052|2-Sided|95.0|-0.8|0.3||Vacations|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643457|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.5719|2-Sided|95.0|-0.7|0.4||Local or long distance travel|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643458|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.1||||0.638|2-Sided|95.0|-0.8|0.5||Work life|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643459|NCT01848990|3021211|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.2||||0.5246|2-Sided|95.0|-0.7|0.4||Leisure activities|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643460|NCT01848990|3021212|Non-Inferiority|prespecific non-inferiority margin of 0.4%|Mean Difference (Final Values)|258.2||||0.9423|2-Sided|95.0|-6792.2|7308.7||Area per day outside of 71 to 139 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Least squares mean treatment difference (Hylenex minus Standard CSII)||
1643461|NCT01848990|3021212|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.8||||0.9232|2-Sided|95.0|-54.2|59.8||Area per day outside of 71 to 180 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643462|NCT01848990|3021212|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|342.9||||0.9241|2-Sided|95.0|-6772.3|7458.2||Area per day ≥140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643463|NCT01848990|3021212|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-84.7||||0.5697|2-Sided|95.0|-379.2|209.8||Area per day ≤70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643464|NCT01848990|3021212|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-33.5||||0.4216|2-Sided|95.0|-115.9|48.9||Area per day <56 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643465|NCT01848990|3021213|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|18.4||||0.5151|2-Sided|95.0|-37.5|74.4||Time per day outside of 71 to 139 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643466|NCT01848990|3021213|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.8||||0.9232|2-Sided|95.0|-54.2|59.8||Time per day outside of 71 to 180 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643467|NCT01848990|3021213|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|23.9||||0.4644|2-Sided|95.0|-40.7|88.6||Time per day ≥140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643468|NCT01848990|3021213|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-23.3||||0.4754|2-Sided|95.0|-87.8|41.2||Time per day <140 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643469|NCT01848990|3021213|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|6.9||||0.5207|2-Sided|95.0|-14.4|28.3||Time per day >70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643470|NCT01848990|3021213|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-5.5||||0.5929|2-Sided|95.0|-25.9|14.9||Time per day ≤70 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643471|NCT01848990|3021213|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.2||||0.6252|2-Sided|95.0|-11.3|6.9||Time per day <56 mg/dL|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643472|NCT01848990|3021214|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-0.7||||0.6571|2-Sided|95.0|-4.0|2.5||Average daily standard deviation|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643473|NCT01848990|3021214|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.8||||0.6058|2-Sided|95.0|-5.0|8.6||Median glucose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643474|NCT01848990|3021214|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.0||||0.7708|2-Sided|95.0|-5.8|7.8||Average glucose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643475|NCT01848990|3021216|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.1||||0.3233|2-Sided|95.0|-6.3|2.1|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643476|NCT01848990|3021217|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.1||||0.8778|2-Sided|95.0|-1.0|1.1|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643477|NCT01848990|3021218|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.4||||0.583|2-Sided|95.0|-3.7|6.6||Daily total dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643478|NCT01848990|3021218|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|2.3||||0.1099|2-Sided|95.0|-0.5|5.2||Daily basal dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643479|NCT01848990|3021218|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.1||||0.4948|2-Sided|95.0|-4.1|2.0||Daily bolus dose|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643480|NCT01848990|3021219|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.13||||0.7735|2-Sided|95.0|-0.76|1.03|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643481|NCT01848990|3021220|Non-Inferiority|prespecific non-inferiority margin of 0.4%||||||0.8926||||||HbA1c ≤6.5%|Chi-squared||||
1643482|NCT01848990|3021220|Non-Inferiority|prespecific non-inferiority margin of 0.4%||||||0.8955||||||HbA1c <7.0%|Chi-squared||||
1643483|NCT01848990|3021221|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.5||||0.8049|2-Sided|95.0|-3.7|4.7|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643484|NCT01848990|3021222|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.4||||0.526|2-Sided|95.0|-5.6|2.9|||ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643485|NCT01848990|3021223|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-2.6||||0.4016|2-Sided|95.0|-8.5|3.4||Overall|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643486|NCT01848990|3021223|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-1.1||||0.7904|2-Sided|95.0|-9.5|7.2||Dinner|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643487|NCT01848990|3021223|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|1.4||||0.754|2-Sided|95.0|-7.4|10.2||Lunch|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643488|NCT01848990|3021223|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-4.8||||0.3239|2-Sided|95.0|-14.3|4.7||Breakfast|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643489|NCT01848990|3021224|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.2||||0.941|2-Sided|95.0|-6.4|6.9||Overall|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643490|NCT01848990|3021224|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|0.0||||0.993|2-Sided|95.0|-9.5|9.6||Dinner|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643491|NCT01848990|3021224|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|4.3||||0.4151|2-Sided|95.0|-6.1|14.8||Lunch|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643492|NCT01848990|3021224|Non-Inferiority|prespecific non-inferiority margin of 0.4%|least squares mean treatment difference|-3.4||||0.5394|2-Sided|95.0|-14.2|7.5||Breakfast|ANOVA|ANOVA with treatment (Hylenex, Standard CSII) as a fixed effect|Hylenex minus Standard CSII||
1643493|NCT01848990|3021225|Non-Inferiority|prespecific non-inferiority margin of 0.4%|rate ratio|1.03||||0.711|2-Sided|||||SMBG >300 mg/dL|negative binomial model||Hylenex/Standard CSII||
1643494|NCT01848990|3021225|Non-Inferiority|prespecific non-inferiority margin of 0.4%|rate ratio|1.04||||0.5414|2-Sided|||||SMBG >240 mg/dL|negative binomial model||Hylenex/Standard CSII||
1643495|NCT01848990|3021226|Non-Inferiority|prespecific non-inferiority margin of 0.4%|rate ratio|0.95||||0.5895|2-Sided|||||SMBG >300 mg/dL|negative binomial model||Hylenex/Standard CSII||
1643496|NCT01848990|3021226|Non-Inferiority|prespecific non-inferiority margin of 0.4%|rate ratio|0.98||||0.7292|2-Sided|||||SMBG >240 mg/dL|negative binomial model||Hylenex/Standard CSII||
1643497|NCT01848990|3021227|Non-Inferiority|prespecific non-inferiority margin of 0.4%|rate ratio|1.07||||0.8909|2-Sided|||||Severe HEs|negative binomial model||Hylenex/Standard CSII||
1643498|NCT01848990|3021227|Non-Inferiority|prespecific non-inferiority margin of 0.4%|rate ratio|0.87||||0.1365|2-Sided|||||Nocturnal HEs|negative binomial model||Hylenex/Standard CSII||
1643499|NCT01848990|3021227|Non-Inferiority|prespecific non-inferiority margin of 0.4%|rate ratio|0.92||||0.2322|2-Sided|||||SMBG <=70 mg/dL|negative binomial model||Hylenex/Standard CSII||
1643500|NCT01848990|3021227|Non-Inferiority|prespecific non-inferiority margin of 0.4%|rate ratio|0.81||||0.0456|2-Sided|||||SMBG <56 mg/dL|negative binomial model||Hylenex/Standard CSII||
1643501|NCT01848990|3021228|Non-Inferiority|prespecific non-inferiority margin of 0.4%|rate ratio|0.34||||0.1176|2-Sided|||||Severe HEs|negative binomial model||Hylenex/Standard CSII||
1643502|NCT01848990|3021228|Non-Inferiority|prespecific non-inferiority margin of 0.4%|rate ratio|0.78||||0.0511|2-Sided|||||Nocturnal HEs|negative binomial model||Hylenex/Standard CSII||
1643503|NCT01848990|3021228|Non-Inferiority|prespecific non-inferiority margin of 0.4%|rate ratio|0.79||||0.013|2-Sided|||||SMBG <=70 mg/dL|negative binomial model||Hylenex/Standard CSII||
1643504|NCT01848990|3021228|Non-Inferiority|prespecific non-inferiority margin of 0.4%|rate ratio|0.69||||0.0105|2-Sided|||||SMBG <56 mg/dL|negative binomial model||Hylenex/Standard CSII||
1643505|NCT01848990|3021229|Non-Inferiority or Equivalence|If the upper bound of the 95% CI for the treatment difference ≤0.40, it is concluded that Hylenex recombinant preadministration is noninferior to standard CSII.|least squares mean treatment difference|0.14||||0.0711|2-Sided|95.0|-0.01|0.28|||ANOVA|ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect|Hylenex minus Standard CSII|Sample size calculated based on approximately 400 Pt being enrolled. No more than 10% dropout rate at 6 months allowed at least 270 Hylenex and 90 standard CSII Pt to reach primary metabolic endpoint evaluation. Assuming HbA1c standard deviation of 0.7% and population difference of 0% between treatments, Pt reaching primary efficacy endpoint would provide >90% power to demonstrate HbA1c noninferiority at margin of 0.4% using confidence bound from 2-tailed 95% confidence interval.|
1643506|NCT01848990|3021230|Non-Inferiority or Equivalence|If the upper bound of the 95% CI for the treatment difference ≤0.40, it is concluded that Hylenex recombinant preadministration is noninferior to standard CSII.|least squares mean treatment difference|0.05||||0.4516|2-Sided|95.0|-0.08|0.18|||ANOVA|Analysis of variance (ANOVA) with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect|Hylenex minus Standard CSII|Sample size calculated based on approximately 400 participants (Pt) being enrolled. No more than 10% dropout rate at 6 months allowed at least 270 Hylenex and 90 standard CSII Pt to reach primary metabolic endpoint evaluation. Assuming HbA1c standard deviation of 0.7% and population difference of 0% between treatments, Pt reaching primary efficacy endpoint would provide >90% power to demonstrate HbA1c noninferiority at margin of 0.4% using confidence bound from 2-tailed 95% confidence interval.|
1643507|NCT01848977|3021233|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|||Unpaired t-test was used to compare the difference between SrO2 and StO2.|
1643508|NCT01848938|3021234|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||analysis between groups|
1643509|NCT01848938|3021235|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||analysis between groups|
1643510|NCT01848938|3021237|Superiority or Other|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||analysis between groups|
1643511|NCT01848938|3021238|Superiority or Other|||||||0.005|||||||Linear Mixed Models analysis|||analysis between groups|
1643512|NCT01848938|3021239|Superiority or Other||||||<|0.001|||||||Linear Mixed Models analysis|||analysis between groups|
1643513|NCT01848210|3021295|Superiority or Other||Mean Difference (Final Values)|-4.65||||0.531|2-Sided|95.0|-19.81|10.51|||Regression, Linear||||
1643514|NCT01848054|3021312|Non-Inferiority or Equivalence|The primary efficacy analysis of retention in treatment at Day 3 was assessed in the per protocol population. In addition, a sensitivity analysis assessed retention in treatment in the full analysis population. For these assessments, the margin to determine non-inferiority (i.e., lower limit of the 95% CI for the difference between BNX and generic buprenorphine of ≥–10%) was selected based on clinical experience to justify comparison between the 2 treatments.|||||<|0.05|||||||t-test, 2 sided|Comparisons between treatment groups were reported with 2-sided p values using 95% CIs for the difference.|||
1643515|NCT01848054|3021319|Non-Inferiority or Equivalence|The primary efficacy analysis of retention in treatment at Day 3 was assessed in the per protocol population. In addition, a sensitivity analysis assessed retention in treatment in the full analysis population. For these assessments, the margin to determine non-inferiority (i.e., lower limit of the 95% CI for the difference between BNX and generic buprenorphine of ≥–10%) was selected based on clinical experience to justify comparison between the 2 treatments.|||||<|0.05|||||||t-test, 2 sided|Comparisons between treatment groups were reported with 2-sided p values using 95% CIs for the difference.|||
1643516|NCT01847547|3021343|Superiority or Other||Hazard Ratio (HR)|1.26||||||95.0|0.79|2.01|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643517|NCT01847547|3021344|Superiority or Other||Hazard Ratio (HR)|0.95||||||95.0|0.67|1.35|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible.|
1643518|NCT01847547|3021345|Superiority or Other||Hazard Ratio (HR)|1.45||||||95.0|0.57|3.7|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643519|NCT01847547|3021346|Superiority or Other||Hazard Ratio (HR)|1.6||||||95.0|0.83|3.08|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643520|NCT01847547|3021347|Superiority or Other||Hazard Ratio (HR)|1.36||||||95.0|0.32|5.72|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and very few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643521|NCT01847547|3021348|Superiority or Other||Hazard Ratio (HR)|0.95||||||95.0|0.58|1.55|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643565|NCT01846741|3021454|Superiority or Other|||||||0.1173|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life|
1644507|NCT01816594|3024419|Superiority|||||||0.786|||||||Fisher Exact|(one-sided)||mutant cohort|
1643522|NCT01847547|3021349|Superiority or Other||Hazard Ratio (HR)|0.4||||||95.0|0.21|0.76|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643523|NCT01847547|3021350|Superiority or Other||Hazard Ratio (HR)|0.74||||||95.0|0.5|1.08|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643524|NCT01847547|3021351|Superiority or Other||Hazard Ratio (HR)|0.65||||||95.0|0.21|1.98|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and very few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643525|NCT01847547|3021352|Superiority or Other||Hazard Ratio (HR)|1.01||||||95.0|0.47|2.2|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643526|NCT01847547|3021353|Superiority or Other||Hazard Ratio (HR)|0.74||||||95.0|0.48|1.14|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643527|NCT01847547|3021355|Superiority or Other||Hazard Ratio (HR)|1.25||||||95.0|0.78|2.01|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643528|NCT01847547|3021356|Superiority or Other||Hazard Ratio (HR)|0.27||||||95.0|0.09|0.84|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643529|NCT01847547|3021357|Superiority or Other||Hazard Ratio (HR)|0.31||||||95.0|0.15|0.67|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible.|
1643530|NCT01847547|3021358|Superiority or Other||Hazard Ratio (HR)|0.29||||||95.0|0.15|0.59|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643531|NCT01847547|3021359|Superiority or Other||Hazard Ratio (HR)|1.24||||||95.0|0.62|2.45|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643532|NCT01847547|3021360|Superiority or Other||Hazard Ratio (HR)|0.97||||||95.0|0.69|1.36|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643533|NCT01847547|3021361|Superiority or Other||Hazard Ratio (HR)|1.05||||||95.0|0.64|1.7|||||Cox Proportional Hazard's regression following propensity score matching.|These current feasibility data are limited by a small sample size, short follow up, and few outcome events resulting in wide 95% confidence intervals. At this early stage, no comparative conclusions are possible. Future data with an increased number of patients are planned.|
1643534|NCT01847443|3021365|Non-Inferiority or Equivalence|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.071|||||2-Sided|90.0|1.028|1.116||||||Null hypothesis stated that there was no difference between the test and reference gums in Cmax|
1643535|NCT01847443|3021366|Non-Inferiority or Equivalence|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.044|||||2-Sided|90.0|1.002|1.089||||||Null hypothesis stated that there was no difference between the test and reference gums in Cmax|
1643536|NCT01847443|3021367|Non-Inferiority or Equivalence|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.098|||||2-Sided|90.0|1.061|1.137||||||Null hypothesis stated that there was no difference between the test and reference gums in AUC(0-t)|
1643537|NCT01847443|3021372|Non-Inferiority or Equivalence|Bioequivalence was to be established between the test and reference treatment if the 90% CI of ratio of geometric means (Test/Reference) was included within the bioequivalence limits of (0.80, 1.25)|Ratio of Geometric means|1.107|||||2-Sided|90.0|1.07|1.147||||||Null hypothesis stated that there was no difference between the test and reference gums in AUC(0-t)|
1643538|NCT01847274|3021407|Superiority||Hazard Ratio (HR)|0.69||||0.0293|2-Sided|95.0|0.494|0.964||Two-sided P-value.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.||
1643717|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|281.43|||||2-Sided|90.0|187.1|423.33||||||Buprenorphine|
1643539|NCT01847274|3021408|Superiority||Hazard Ratio (HR)|0.48||||0.0062|2-Sided|95.0|0.28|0.821||Two-sided P-value.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.||
1643540|NCT01847274|3021409|Superiority||Hazard Ratio (HR)|0.5|||<|0.0001|2-Sided|95.0|0.37|0.666||Two-sided P-value.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.||
1643541|NCT01847274|3021410|Superiority||Hazard Ratio (HR)|0.26|||<|0.0001|2-Sided|95.0|0.166|0.409||Two-sided P-value.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.||
1643542|NCT01847274|3021411|Superiority||Hazard Ratio (HR)|0.55|||<|0.0001|2-Sided|95.0|0.412|0.721||Two-sided P-value.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.||
1643543|NCT01847274|3021412|Superiority||Hazard Ratio (HR)|0.31|||<|0.0001|2-Sided|95.0|0.205|0.481||Two-sided P-value.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.||
1643544|NCT01847274|3021413|Superiority||Hazard Ratio (HR)|0.45|||<|0.0001|2-Sided|95.0|0.338|0.607||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.||
1643545|NCT01847274|3021414|Superiority||Hazard Ratio (HR)|0.38|||<|0.0001|2-Sided|95.0|0.243|0.586||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort. Hierarchical testing: HRD+ subset tested first. If HRD+ subset demonstrated statistical significance, overall non-gBRCA cohort was then tested|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.||
1643546|NCT01847274|3021415|Superiority||Hazard Ratio (HR)|0.27|||<|0.0001|2-Sided|95.0|0.173|0.41||Two-sided P-value. PFS was independently evaluated in gBRCAmut cohort and non-gBRCAmut cohort.|Log Rank|Strata: tm to progression after penultimate platinum tx; use of bevacizumab w/penultimate or last platinum tx; best response during last platinum tx.|Niraparib:Placebo, based on the stratified Cox Proportional Hazards Model using randomization stratification factors.||
1643547|NCT01847092|3021422|Superiority|||||||0.94|||||||ANCOVA||||
1643548|NCT01847092|3021423|Superiority|||||||0.279|||||||Mixed Models Analysis||||
1643549|NCT01846871|3021434|Other|||||||0.033|||||||t-test, 2 sided||||
1643550|NCT01846871|3021435|Other|||||||0.0019|||||||t-test, 2 sided||||
1643551|NCT01846871|3021436|Other|||||||0.028|||||||t-test, 2 sided||||
1643552|NCT01846871|3021437|Other|||||||0.7|||||||t-test, 2 sided||||
1643553|NCT01846741|3021452|Superiority or Other|||||||0.5417|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||18 Months|
1643554|NCT01846741|3021452|Superiority or Other|||||||0.0342|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||12 months|
1643555|NCT01846741|3021452|Superiority or Other|||||||0.1094|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||6 months|
1643556|NCT01846741|3021452|Superiority or Other|||||||0.0625|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||3 months|
1643557|NCT01846741|3021454|Superiority or Other|||||||0.0155|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life|
1643558|NCT01846741|3021454|Superiority or Other|||||||0.0024|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry|
1643559|NCT01846741|3021454|Superiority or Other|||||||0.0615|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final|
1643560|NCT01846741|3021454|Superiority or Other|||||||0.0361|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final|
1643561|NCT01846741|3021454|Superiority or Other|||||||0.0987|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final|
1643562|NCT01846741|3021454|Superiority or Other|||||||0.7926|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional Well Being Final|
1643563|NCT01846741|3021454|Superiority or Other|||||||0.4406|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final|
1643564|NCT01846741|3021454|Superiority or Other|||||||0.0268|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total|
1643666|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|132.72|||||2-Sided|90.0|100.93|174.53||||||Naloxone-3-β-D-Glucuronide|
1643566|NCT01846741|3021454|Superiority or Other|||||||0.0056|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry|
1643567|NCT01846741|3021454|Superiority or Other|||||||0.2753|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects|
1643568|NCT01846741|3021454|Superiority or Other|||||||0.0401|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning|
1643569|NCT01846741|3021454|Superiority or Other|||||||0.1738|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning|
1643570|NCT01846741|3021454|Superiority or Other|||||||0.1639|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being|
1643571|NCT01846741|3021454|Superiority or Other|||||||0.1921|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue|
1643572|NCT01846741|3021454|Superiority or Other|||||||0.0361|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score|
1643573|NCT01846741|3021454|Superiority or Other|||||||0.0353|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life|
1643574|NCT01846741|3021454|Superiority or Other|||||||0.024|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry|
1643575|NCT01846741|3021454|Superiority or Other|||||||0.3522|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects|
1643576|NCT01846741|3021454|Superiority or Other|||||||0.0015|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning|
1643577|NCT01846741|3021454|Superiority or Other|||||||0.0136|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning|
1643578|NCT01846741|3021454|Superiority or Other|||||||0.1508|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being|
1643579|NCT01846741|3021454|Superiority or Other|||||||0.5874|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue|
1643580|NCT01846741|3021454|Superiority or Other|||||||0.0094|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total|
1643581|NCT01846741|3021454|Superiority or Other|||||||0.104|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life|
1643582|NCT01846741|3021454|Superiority or Other|||||||0.0826|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry|
1643583|NCT01846741|3021454|Superiority or Other|||||||0.3247|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects|
1643584|NCT01846741|3021454|Superiority or Other|||||||0.0014|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning|
1643585|NCT01846741|3021454|Superiority or Other|||||||0.1111|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning|
1643586|NCT01846741|3021454|Superiority or Other|||||||0.2416|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being|
1643587|NCT01846741|3021454|Superiority or Other|||||||0.8069|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue|
1643588|NCT01846741|3021454|Superiority or Other|||||||0.0192|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total|
1643589|NCT01846741|3021455|Superiority or Other|||||||0.0273|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score|
1643590|NCT01846741|3021455|Superiority or Other|||||||0.0078|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score|
1643591|NCT01846741|3021455|Superiority or Other|||||||0.0078|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score|
1643592|NCT01846741|3021455|Superiority or Other|||||||0.0005|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score|
1643593|NCT01846741|3021455|Superiority or Other|||||||0.0005|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score|
1643594|NCT01846741|3021455|Superiority or Other|||||||0.0728|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score|
1644508|NCT01816594|3024420|Superiority|||||||0.83|||||||Fisher Exact|(one-sided)||wild type cohort|
1643595|NCT01846741|3021455|Superiority or Other|||||||0.0003|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score|
1643596|NCT01846741|3021455|Superiority or Other|||||||0.0679|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery|
1643597|NCT01846741|3021455|Superiority or Other|||||||0.0284|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery|
1643598|NCT01846741|3021455|Superiority or Other|||||||0.0234|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery|
1643599|NCT01846741|3021455|Superiority or Other|||||||0.0096|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity|
1643600|NCT01846741|3021455|Superiority or Other|||||||0.0092|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery|
1643601|NCT01846741|3021455|Superiority or Other|||||||0.0828|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure|
1643602|NCT01846741|3021455|Superiority or Other|||||||0.0031|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score|
1643603|NCT01846741|3021455|Superiority or Other|||||||0.1526|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery|
1643604|NCT01846741|3021455|Superiority or Other|||||||0.0875|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery|
1643605|NCT01846741|3021455|Superiority or Other|||||||0.0078|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery|
1643606|NCT01846741|3021455|Superiority or Other|||||||0.0114|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity|
1643607|NCT01846741|3021455|Superiority or Other|||||||0.0214|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery|
1643608|NCT01846741|3021455|Superiority or Other|||||||0.1173|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure|
1643609|NCT01846741|3021455|Superiority or Other|||||||0.0007|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score|
1643610|NCT01846741|3021455|Superiority or Other|||||||0.0884|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score|
1643611|NCT01846741|3021455|Superiority or Other|||||||0.0742|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score|
1643612|NCT01846741|3021455|Superiority or Other|||||||0.0156|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score|
1643613|NCT01846741|3021455|Superiority or Other|||||||0.0163|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score|
1643614|NCT01846741|3021455|Superiority or Other|||||||0.0207|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score|
1643615|NCT01846741|3021455|Superiority or Other|||||||0.0544|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizure Score|
1643616|NCT01846741|3021455|Superiority or Other|||||||0.0008|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score|
1643617|NCT01846741|3021456|Superiority or Other|||||||0.625|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months|
1643618|NCT01846741|3021456|Superiority or Other|||||||0.031|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months|
1643619|NCT01846741|3021456|Superiority or Other|||||||0.057|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 18 Months|
1643620|NCT01846741|3021456|Superiority or Other|||||||0.999|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 12 months|
1643621|NCT01846741|3021456|Superiority or Other|||||||0.25|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 6 months|
1643622|NCT01846741|3021456|Superiority or Other|||||||0.938|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months|
1643623|NCT01846741|3021456|Superiority or Other|||||||0.156|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 12 months|
1643624|NCT01846741|3021456|Superiority or Other|||||||0.75|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 6 months|
1643625|NCT01846741|3021456|Superiority or Other|||||||0.5|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months|
1643626|NCT01846741|3021456|Superiority or Other|||||||0.033|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 months|
1643627|NCT01846741|3021456|Superiority or Other|||||||0.04|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 months|
1643628|NCT01846741|3021456|Superiority or Other|||||||0.008|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Baseline to 3 months|
1643629|NCT01846728|3021462|Other|||||||0.66|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations|
1643630|NCT01846728|3021463|Other|||||||0.98|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations|
1643631|NCT01846728|3021464|Other|Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations||||||0.92|||||||t-test, 2 sided||||
1643632|NCT01846728|3021465|Other|||||||0.66|||||||t-test, 2 sided|||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations|
1643633|NCT01846728|3021466|Other|||||||0.84||||||Because this was a pilot study, the study was not powered to detect differences over time. the study was performed to generate preliminary data on means and standard deviations|t-test, 2 sided||||
1643634|NCT01846611|3021482|Superiority||Odds Ratio (OR)|1.523|||=|0|2-Sided|95.0|1.075|2.158|||Fisher Exact||||
1643635|NCT01846611|3021483|Superiority||Hazard Ratio (HR)|0.935|||=|0|2-Sided|95.0|0.762|1.147|||Unstratified log rank test||||
1643636|NCT01846611|3021484|Superiority||Hazard Ratio (HR)|0.925|||=|0|2-Sided|95.0|0.727|1.177|||Unstratified log rank test||||
1643637|NCT01846494|3021492|Other|||||||0.6173|||||||Log Rank||||
1643638|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|99.02|||||2-Sided|90.0|73.93|132.61||||||Naloxone-3-β-D-Glucuronide|
1643639|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|134.06|||||2-Sided|90.0|101.07|177.82||||||Naloxone-3-β-D-Glucuronide|
1643640|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|101.71|||||2-Sided|90.0|74.96|138.0||||||Naloxone-3-β-D-Glucuronide|
1643641|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|82.78|||||2-Sided|90.0|59.89|114.42||||||Naloxone-3-β-D-Glucuronide|
1643642|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|81.97|||||2-Sided|90.0|60.03|111.92||||||Naloxone-3-β-D-Glucuronide|
1643643|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|110.98|||||2-Sided|90.0|82.02|150.17||||||Naloxone-3-β-D-Glucuronide|
1643644|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|84.2|||||2-Sided|90.0|60.92|116.38||||||Naloxone-3-β-D-Glucuronide|
1643645|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|1708.83|||||2-Sided|90.0|744.08|3924.47||||||Naloxone|
1643646|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|321.94|||||2-Sided|90.0|144.65|716.52||||||Naloxone|
1643647|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|78.86|||||2-Sided|90.0|34.34|181.12||||||Naloxone|
1643648|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|87.64|||||2-Sided|90.0|40.3|190.59||||||Naloxone|
1643649|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|1497.7|||||2-Sided|90.0|724.85|3094.59||||||Naloxone|
1643650|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|282.17|||||2-Sided|90.0|141.59|562.3||||||Naloxone|
1643651|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|69.12|||||2-Sided|90.0|33.45|142.82||||||Naloxone|
1643652|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|122.77|||||2-Sided|90.0|60.24|250.19||||||Norbuprenorphine|
1643653|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|182.98|||||2-Sided|90.0|89.79|372.89||||||Norbuprenorphine|
1643654|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|87.1|||||2-Sided|90.0|42.74|177.5||||||Norbuprenorphine|
1643655|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|106.93|||||2-Sided|90.0|52.47|217.91||||||Norbuprenorphine|
1643656|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|159.38|||||2-Sided|90.0|78.21|324.79||||||Norbuprenorphine|
1643657|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|263.97|||||2-Sided|90.0|155.52|448.03||||||Buprenorphine|
1643658|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|233.99|||||2-Sided|90.0|135.63|403.68||||||Buprenorphine|
1643659|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|132.57|||||2-Sided|90.0|78.86|222.84||||||Buprenorphine|
1643660|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|94.44|||||2-Sided|90.0|56.44|158.02||||||Buprenorphine|
1643661|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|249.28|||||2-Sided|90.0|162.19|383.14||||||Buprenorphine|
1643662|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|220.97|||||2-Sided|90.0|135.33|360.81||||||Buprenorphine|
1643663|NCT01846455|3021501|Superiority or Other||ratio of parameter means, %|125.19|||||2-Sided|90.0|79.46|197.24||||||Buprenorphine|
1643664|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|99.33|||||2-Sided|90.0|75.54|130.61||||||Naloxone-3-β-D-Glucuronide|
1643665|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|132.95|||||2-Sided|90.0|102.12|173.1||||||Naloxone-3-β-D-Glucuronide|
1643667|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|83.66|||||2-Sided|90.0|64.75|108.08||||||Naloxone-3-β-D-Glucuronide|
1643668|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|83.09|||||2-Sided|90.0|64.32|107.35||||||Naloxone-3-β-D-Glucuronide|
1643669|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|111.22|||||2-Sided|90.0|87.02|142.16||||||Naloxone-3-β-D-Glucuronide|
1643670|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|111.03|||||2-Sided|90.0|85.94|143.44||||||Naloxone-3-β-D-Glucuronide|
1643671|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|894.91|||||2-Sided|90.0|436.49|1834.8||||||Naloxone|
1643672|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|213.86|||||2-Sided|90.0|107.07|427.17||||||Naloxone|
1643673|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|79.53|||||2-Sided|90.0|38.79|163.06||||||Naloxone|
1643674|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|126.25|||||2-Sided|90.0|64.5|247.11||||||Naloxone|
1643675|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|1129.81|||||2-Sided|90.0|577.22|2211.44||||||Naloxone|
1643676|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|270.0|||||2-Sided|90.0|141.86|513.9||||||Naloxone|
1643677|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|100.41|||||2-Sided|90.0|51.3|196.53||||||Naloxone|
1643678|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|63.17|||||2-Sided|90.0|33.87|117.83||||||Norbuprenorphine|
1643679|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|88.62|||||2-Sided|90.0|48.6|161.59||||||Norbuprenorphine|
1643680|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|176.48|||||2-Sided|90.0|94.62|329.17||||||Norbuprenorphine|
1643681|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|76.59|||||2-Sided|90.0|42.75|137.22||||||Norbuprenorphine|
1643682|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|48.39|||||2-Sided|90.0|27.01|86.69||||||Norbuprenorphine|
1643683|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|67.87|||||2-Sided|90.0|38.82|118.68||||||Norbuprenorphine|
1643684|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|135.17|||||2-Sided|90.0|75.44|242.16||||||Norbuprenorphine|
1643685|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|152.24|||||2-Sided|90.0|103.08|224.83||||||Buprenorphine|
1643686|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|95.59|||||2-Sided|90.0|64.36|141.99||||||Buprenorphine|
1643687|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|106.38|||||2-Sided|90.0|71.43|158.43||||||Buprenorphine|
1643688|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|112.82|||||2-Sided|90.0|77.66|163.91||||||Buprenorphine|
1643689|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|171.76|||||2-Sided|90.0|117.93|250.15||||||Buprenorphine|
1643690|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|107.85|||||2-Sided|90.0|75.85|153.36||||||Buprenorphine|
1643691|NCT01846455|3021502|Superiority or Other||ratio of parameter means, %|120.02|||||2-Sided|90.0|83.35|172.82||||||Buprenorphine|
1643692|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|107.64|||||2-Sided|90.0|81.33|142.47||||||Naloxone-3-β-D-Glucuronide|
1643693|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|145.99|||||2-Sided|90.0|111.43|191.26||||||Naloxone-3-β-D-Glucuronide|
1643694|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|101.28|||||2-Sided|90.0|76.52|134.06||||||Naloxone-3-β-D-Glucuronide|
1643695|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|84.78|||||2-Sided|90.0|65.23|110.2||||||Naloxone-3-β-D-Glucuronide|
1643696|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|91.26|||||2-Sided|90.0|70.21|118.62||||||Naloxone-3-β-D-Glucuronide|
1643697|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|123.77|||||2-Sided|90.0|96.27|159.13||||||Naloxone-3-β-D-Glucuronide|
1643698|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|85.87|||||2-Sided|90.0|66.06|111.61||||||Naloxone-3-β-D-Glucuronide|
1643699|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|1325.22|||||2-Sided|90.0|638.03|2752.55||||||Naloxone|
1643700|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|300.22|||||2-Sided|90.0|148.44|607.21||||||Naloxone|
1643701|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|74.97|||||2-Sided|90.0|36.09|155.71||||||Naloxone|
1643702|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|105.78|||||2-Sided|90.0|53.39|209.59||||||Naloxone|
1643703|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|1401.85|||||2-Sided|90.0|707.55|2777.46||||||Naloxone|
1643704|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|317.58|||||2-Sided|90.0|164.93|611.54||||||Naloxone|
1643705|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|79.3|||||2-Sided|90.0|40.03|157.12||||||Naloxone|
1643706|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|16.12|||||2-Sided|90.0|8.4|30.94||||||Norbuprenorphine|
1643707|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|105.23|||||2-Sided|90.0|52.17|212.24||||||Norbuprenorphine|
1643708|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|109.9|||||2-Sided|90.0|58.14|207.75||||||Norbuprenorphine|
1643709|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|71.08|||||2-Sided|90.0|39.0|129.49||||||Norbuprenorphine|
1643710|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|11.45|||||2-Sided|90.0|6.35|20.66||||||Norbuprenorphine|
1643711|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|74.78|||||2-Sided|90.0|39.26|142.41||||||Norbuprenorphine|
1643712|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|78.09|||||2-Sided|90.0|44.03|138.49||||||Norbuprenorphine|
1643713|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|358.83|||||2-Sided|90.0|231.92|555.17||||||Buprenorphine|
1643714|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|208.94|||||2-Sided|90.0|137.21|318.18||||||Buprenorphine|
1643715|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|126.66|||||2-Sided|90.0|81.87|195.97||||||Buprenorphine|
1643718|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|163.88|||||2-Sided|90.0|110.82|242.34||||||Buprenorphine|
1643719|NCT01846455|3021503|Superiority or Other||ratio of parameter means, %|99.34|||||2-Sided|90.0|66.05|149.43||||||Buprenorphine|
1643720|NCT01846299|3021539|Superiority or Other||Mean Difference (Net)|2.78|Standard Error of the Mean|1.203||0.0111|2-Sided|95.0|0.4|5.16|||Mixed Models Analysis||||
1643721|NCT01846273|3021556|Superiority||||||<|0.0001|||||||Fisher Exact||||
1643722|NCT01846273|3021557|Non-Inferiority|pre-defined non-inferiority margin of 5 letters|Least Squares Mean|3.2|||<|0.001|1-Sided|95.0|0.38||||ANCOVA||||
1643723|NCT01846221|3021562|Other|||||||0.38|||||||ANOVA||||
1643724|NCT01846208|3021564|Superiority||Risk Difference (RD)|33.7||||0.023|2-Sided|95.0|7.2|60.1|||Barnard's Exact Test|||% participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Egg OIT-Randomized vs. Egg OIT-Assigned|
1643725|NCT01846208|3021564|Superiority||Risk Difference (RD)|-50.2||||0.003|2-Sided|95.0|-78.4|-21.9|||Barnard's Exact Test|||% participants with unrestricted consumption of unbaked (concentrated) egg 3 years after randomization: Baked vs. Egg OIT-Randomized|
1643726|NCT01846208|3021566|Superiority||Risk Difference (RD)|17.5||||0.181|2-Sided|95.0|-6.3|41.3|||Barnard's Exact Test|||% participants desensitized to >=4444 mg at Year 1 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned|
1643727|NCT01846208|3021566|Superiority||Risk Difference (RD)|44.3||||0.002|2-Sided|95.0|19.4|69.2|||Barnard's Exact Test|||% participants desensitized to >=4444 mg at Year 1 OFC: Baked vs. Egg OIT-Randomized|
1643728|NCT01846208|3021566|Superiority||Risk Difference (RD)|17.7||||0.151|2-Sided|95.0|-2.3|37.7|||Barnard's Exact Test|||% participants desensitized to >=4444 mg at Year 2 OFC: Egg OIT-Randomized vs. Egg OIT-Assigned|
1643729|NCT01846208|3021566|Superiority||Risk Difference (RD)|64.7|||<|0.0001|2-Sided|95.0|43.9|85.6|||Barnard's Exact Test|||% participants desensitized to >=4444 mg at Year 2 OFC: Baked vs. Egg OIT-Randomized|
1643730|NCT01846208|3021567|Superiority||Risk Difference (RD)|25.5||||0.031|2-Sided|95.0|2.0|49.1|||Barnard's Exact Test|||% participants passed Year 2 SU OFC: Egg OIT-Randomized vs. Egg OIT-Assigned|
1643731|NCT01846208|3021567|Superiority||Risk Difference (RD)|32.4||||0.009|2-Sided|95.0|8.9|55.8|||Barnard's Exact Test|||% participants passed Year 2 SU OFC: Baked vs. Egg OIT-Randomized|
1643732|NCT01845077|3021619|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|107.7|||||2-Sided|90.0|92.5|125.4|||||||
1643733|NCT01845077|3021619|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|103.2|||||2-Sided|90.0|98.9|107.7|||||||
1643734|NCT01845077|3021619|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.5|||||2-Sided|90.0|84.8|109.8|||||||
1643735|NCT01845077|3021620|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.3|||||2-Sided|90.0|90.1|109.5|||||||
1643736|NCT01845077|3021620|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.4|||||2-Sided|90.0|95.6|103.4|||||||
1643737|NCT01845077|3021620|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.8|||||2-Sided|90.0|86.6|108.2|||||||
1643738|NCT01845077|3021621|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|95.9|||||2-Sided|90.0|86.7|106.0|||||||
1643739|NCT01845077|3021621|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.7|||||2-Sided|90.0|96.1|103.5|||||||
1643740|NCT01845077|3021621|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.9|||||2-Sided|90.0|86.8|108.2|||||||
1643741|NCT01845077|3021622|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.9|||||2-Sided|90.0|90.2|104.1|||||||
1643742|NCT01845077|3021622|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|105.3|||||2-Sided|90.0|99.9|111.0|||||||
1643743|NCT01845077|3021622|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|103.7|||||2-Sided|90.0|97.1|110.8|||||||
1643744|NCT01845077|3021623|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|108.6||||||90.0|99.5|118.5|||||||
1643745|NCT01845077|3021623|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|96.8|||||2-Sided|90.0|90.2|103.8|||||||
1643807|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.52|||||2-Sided|95.0|0.38|0.71|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression >= 1%||
1643746|NCT01845077|3021623|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|94.9|||||2-Sided|90.0|86.8|103.6|||||||
1643747|NCT01845077|3021624|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|100.9|||||2-Sided|90.0|98.2|103.7|||||||
1643748|NCT01845077|3021624|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|101.5|||||2-Sided|90.0|98.4|104.7||||||One patient was excluded from this analysis due to the lack of the 72h sample for the L+M1000 fed treatment.|
1643749|NCT01845077|3021624|Non-Inferiority or Equivalence|Standard acceptance criterion for bioequivalence: 90% confidence interval is completely within the bounds of 80-125%. No formal hypothesis test was conducted as study is exploratory.|Ratio of geometric means|99.3|||||2-Sided|90.0|95.3|103.5|||||||
1643750|NCT01844986|3021634|Superiority||Hazard Ratio (HR)|0.3|||<|0.0001|2-Sided|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio < 1 favours olaparib||
1643751|NCT01844986|3021635|Superiority||Hazard Ratio (HR)|0.63|||<|0.0001|2-Sided|95.0|0.51|0.79||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio < 1 favours olaparib||
1643752|NCT01844986|3021636|Superiority||Hazard Ratio (HR)|0.45|||<|0.0001|2-Sided|95.0|0.32|0.63||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio < 1 favours olaparib||
1643753|NCT01844986|3021637|Superiority||Hazard Ratio (HR)|0.3|||<|0.0001|2-Sided|95.0|0.22|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio < 1 favours olaparib||
1643754|NCT01844986|3021638|Superiority||Mean Difference (Final Values)|-3.0||||0.001|2-Sided|95.0|-4.779|-1.216|||Mixed Models Analysis|Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.|||
1643755|NCT01844986|3021639|Superiority||Hazard Ratio (HR)|0.5||||0.0002|2-Sided|95.0|0.35|0.72||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio < 1 favours olaparib||
1643756|NCT01844986|3021640|Superiority||Hazard Ratio (HR)|0.3|||<|0.0001|2-Sided|95.0|0.23|0.4||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio < 1 favours olaparib||
1643757|NCT01844986|3021641|Superiority||Hazard Ratio (HR)|0.95||||0.8903|2-Sided|95.0|0.6|1.53||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio < 1 favours olaparib||
1643758|NCT01844986|3021642|Superiority||Hazard Ratio (HR)|0.3|||<|0.0001|2-Sided|95.0|0.23|0.41||Determined using a log-rank test stratified by response to previous platinum chemotherapy|Regression, Cox|Model includes a factor for response to previous platinum chemotherapy|A hazard ratio < 1 favours olaparib||
1643759|NCT01844895|3021648|Superiority or Other||geometric mean ratio|0.91|||||2-Sided|90.0|0.83|1.0||||||A mixed-effect model of log (Cminss) with device and substudy baseline weight category (< 60 kg,60-100 kg, > 100 kg) as fixed effects and participant as a random effect was used. Point estimates and 90% CIs for device differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale. No adjustment was made for multiplicity. PK comparability was concluded if the 90% CIs for the ratios of geometric means were contained within 80% to 125%.|
1643760|NCT01844583|3021712|Superiority or Other||LS Mean Ratio|0.53|||||2-Sided|90.0|0.41|0.7|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.||
1643761|NCT01844583|3021713|Superiority or Other||LS Mean Ratio|0.51|||||2-Sided|90.0|0.41|0.62|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.||
1643762|NCT01844583|3021714|Superiority or Other||LS Mean Ratio|1.03|||||2-Sided|90.0|0.84|1.26|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.||
1643763|NCT01844583|3021717|Superiority or Other||LS Mean Ratio|1.28|||||2-Sided|90.0|1.07|1.53|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.||
1643764|NCT01844583|3021718|Superiority or Other||LS Mean Ratio|1.25|||||2-Sided|90.0|1.08|1.45|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.||
1643765|NCT01844583|3021719|Superiority or Other||LS Mean Ratio|1.14|||||2-Sided|90.0|0.97|1.35|||||Estimates for each PK parameter were obtained using a mixed effects model of log (PK parameter) with fixed terms for the esomeprazole effect and random terms for participants within sequence.||
1643766|NCT01844531|3021720|Superiority or Other||Adjusted gMean ratio FDC/single tablets|96.1|Standard Error of the Mean|9.3|<|0.0001|2-Sided|90.0|91.28|101.19|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability − analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUClast [ng*h/mL] for METFORMIN (PLASMA EDTA)|
1643808|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.74||||||95.0|0.52|1.06|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression < 1%||
1643997|NCT01836471|3022582|Superiority or Other||least squares mean|-0.17|Standard Error of the Mean|0.134|||2-Sided|95.0|-0.43|0.09|||||||
1643767|NCT01844531|3021720|Superiority or Other||Adjusted gMean ratio FDC/single tablets|95.94|Standard Error of the Mean|9.3|<|0|2-Sided|90.0|91.199|100.934|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUClast [ng*h/mL] for METFORMIN (PLASMA EDTA)|
1643768|NCT01844531|3021720|Superiority or Other||Adjusted gMean ratio FDC/single tablets|96.74|Standard Error of the Mean|15.5|<|0.0006|2-Sided|90.0|88.78|105.41|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability − analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast [ng*h/mL] for METFORMIN (PLASMA EDTA)|
1643769|NCT01844531|3021720|Superiority or Other||Adjusted gMean ratio FDC/single tablets|95.78|Standard Error of the Mean|15.7|<|0.0008|2-Sided|90.0|88.0|104.256|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast [ng*h/mL] for METFORMIN (PLASMA EDTA)|
1643770|NCT01844531|3021721|Superiority or Other||Adjusted gMean ratio FDC/single tablets|93.98|Standard Error of the Mean|12.0||0.0003|2-Sided|90.0|87.94|100.43|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability − analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set Cmax [ng/mL] for METFORMIN (PLASMA EDTA)|
1643771|NCT01844531|3021721|Superiority or Other||Adjusted gMean ratio FDC/single tablets|93.83|Standard Error of the Mean|11.9||0.0002|2-Sided|90.0|88.006|100.034|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set Cmax [ng/mL] for METFORMIN (PLASMA EDTA)|
1643772|NCT01844531|3021721|Superiority or Other||Adjusted gMean ratio FDC/single tablets|94.4|Standard Error of the Mean|11.4||0.0001|2-Sided|90.0|88.64|100.54|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability − analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax [ng/mL] for METFORMIN (PLASMA EDTA)|
1643773|NCT01844531|3021721|Superiority or Other||Adjusted gMean ratio FDC/single tablets|94.76|Standard Error of the Mean|11.4||0.0001|2-Sided|90.0|89.056|100.819|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax [ng/mL] for METFORMIN (PLASMA EDTA)|
1643774|NCT01844531|3021722|Superiority or Other||Adjusted gMean ratio FDC/single tablets|102.8|Standard Error of the Mean|9.2|<|0.0001|2-Sided|90.0|97.72|108.14|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability − analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set Cmax [nmol/L] for EMPAGLIFLOZIN (PLASMA EDTA)|
1643775|NCT01844531|3021722|Superiority or Other||Adjusted gMean ratio FDC/single tablets|102.96|Standard Error of the Mean|9.2|<|0|2-Sided|90.0|97.917|108.258|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set Cmax [nmol/L] for EMPAGLIFLOZIN (PLASMA EDTA)|
1643776|NCT01844531|3021722|Superiority or Other||Adjusted gMean ratio FDC/single tablets|104.53|Standard Error of the Mean|8.4|<|0.0001|2-Sided|90.0|99.76|109.53|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability − analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax [nmol/L] for EMPAGLIFLOZIN (PLASMA EDTA)|
1643777|NCT01844531|3021722|Superiority or Other||Adjusted gMean ratio FDC/single tablets|104.61|Standard Error of the Mean|8.4|<|0|2-Sided|90.0|99.882|109.555|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set Cmax [nmol/L] for EMPAGLIFLOZIN (PLASMA EDTA)|
1643778|NCT01844531|3021723|Superiority or Other||Adjusted gMean ratio FDC/single tablets|102.49|Standard Error of the Mean|6.5|<|0.0001|2-Sided|90.0|98.85|106.25|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability − analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUClast [nmol*h/L] for EMPAGLIFLOZIN (PLASMA EDTA)|
1643779|NCT01844531|3021723|Superiority or Other||Adjusted gMean ratio FDC/single tablets|102.77|Standard Error of the Mean|6.5|<|0|2-Sided|90.0|99.146|106.522|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUClast [nmol*h/L] for EMPAGLIFLOZIN (PLASMA EDTA)|
1643780|NCT01844531|3021723|Superiority or Other||Adjusted gMean ratio FDC/single tablets|98.07|Standard Error of the Mean|8.5|<|0.0001|2-Sided|90.0|93.55|102.81|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability − analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast [nmol*h/L] for EMPAGLIFLOZIN (PLASMA EDTA)|
1643781|NCT01844531|3021723|Superiority or Other||Adjusted gMean ratio FDC/single tablets|98.0|Standard Error of the Mean|8.5|<|0|2-Sided|90.0|93.53|102.686|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUClast [nmol*h/L] for EMPAGLIFLOZIN (PLASMA EDTA)|
1643782|NCT01844531|3021724|Superiority or Other||Adjusted gMean ratio FDC/single tablets|96.91|Standard Error of the Mean|9.8|<|0.0001|2-Sided|90.0|91.79|102.32|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability − analysis with fixed effects for all terms comparison FDC Empa5 : Empa5 + Met500, PK set AUCinfpred [ng*h/mL] for METFORMIN (PLASMA EDTA)|
1643783|NCT01844531|3021724|Superiority or Other||Adjusted gMean ratio FDC/single tablets|96.79|Standard Error of the Mean|9.8|<|0|2-Sided|90.0|91.772|102.093|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500, PK set AUCinfpred [ng*h/mL] for METFORMIN (PLASMA EDTA)|
1643784|NCT01844531|3021724|Superiority or Other||Adjusted gMean ratio FDC/single tablets|97.21|Standard Error of the Mean|15.1|<|0.0004|2-Sided|90.0|89.41|105.68|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability − analysis with fixed effects for all terms comparison FDC Empa12.5 (T1) : Empa12.5 + Met500 (R1), PK set AUCinfpred [ng*h/mL] for METFORMIN (PLASMA EDTA)|
1643785|NCT01844531|3021724|Superiority or Other||Adjusted gMean ratio FDC/single tablets|96.25|Standard Error of the Mean|15.4|<|0.0006|2-Sided|90.0|88.542|104.628|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred [ng*h/mL] for METFORMIN (PLASMA EDTA)|
1643786|NCT01844531|3021725|Superiority or Other||Adjusted gMean ratio FDC/single tablets|102.5|Standard Error of the Mean|6.7|<|0.0001|2-Sided|90.0|98.78|106.36|||ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability − analysis with fixed effects for all terms comparison FDC Empa5 (T2) : Empa5 + Met500 (R2), PK set AUCinfpred [nmol*h/L] for EMPAGLIFLOZIN (PLASMA EDTA)|
1643787|NCT01844531|3021725|Superiority or Other||Adjusted gMean ratio FDC/single tablets|102.79|Standard Error of the Mean|6.7|<|0|2-Sided|90.0|99.077|106.633||Model included effects:sequence;subjects within sequences;period and treatment with subjects within sequences as random effect.|ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability comparison FDC Empa5 : Empa5 + Met500 , PK set AUCinfpred [nmol*h/L] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.|
1643788|NCT01844531|3021725|Superiority or Other||Adjusted gMean ratio FDC/single tablets|98.0|Standard Error of the Mean|8.3|<|0.0001|2-Sided|90.0|93.57|102.65||Model included effects:sequence;subjects within sequences;period and treatment with all effects as fixed.|ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability − analysis with fixed effects for all terms comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred [nmol*h/L] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.|
1643789|NCT01844531|3021725|Superiority or Other||Adjusted gMean ratio FDC/single tablets|97.92|Standard Error of the Mean|8.4|<|0|2-Sided|90.0|93.529|102.52||Model included effects:sequence;subjects within sequences;period and treatment with subjects within sequences as random effect.|ANOVA||*Results reported as Standard Error of the mean are Intra-individual geometric coefficient of variation [%].|Adjusted by−treatment geometric means and relative bioavailability comparison FDC Empa12.5 : Empa12.5 + Met500, PK set AUCinfpred [nmol*h/L] for EMPAGLIFLOZIN (PLASMA EDTA). The statistical model used was an analysis of variance (ANOVA) model on the logarithmic scale.|
1643790|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.68|||||2-Sided|95.0|0.34|1.39|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression not evaluable at baseline||
1643791|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.48|||||2-Sided|95.0|0.26|0.91|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline||
1643792|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.71|||||2-Sided|95.0|0.37|1.34|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline||
1643793|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.88|||||2-Sided|95.0|0.46|1.71|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression >= 10%||
1643794|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.53|||||2-Sided|95.0|0.29|0.99|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression >= 10%||
1643795|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.6|||||2-Sided|95.0|0.35|1.05|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression >= 10%||
1643796|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.68|1.17|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression < 10%||
1643797|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.57|||||2-Sided|95.0|0.44|0.74|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression < 10%||
1643798|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.64|||||2-Sided|95.0|0.5|0.82|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression < 10%||
1643799|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|1.05|||||2-Sided|95.0|0.61|1.83|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression >= 5%||
1643800|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.6|||||2-Sided|95.0|0.36|1.0|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression >= 5%||
1643801|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.57|||||2-Sided|95.0|0.35|0.92|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression >= 5%||
1643802|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.84|||||2-Sided|95.0|0.63|1.12|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression < 5%||
1643803|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.55|||||2-Sided|95.0|0.42|0.72|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression < 5%||
1643804|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.65|||||2-Sided|95.0|0.5|0.85|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression < 5%||
1643805|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|1.03|||||2-Sided|95.0|0.72|1.48|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression >= 1%||
1643806|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.53|||||2-Sided|95.0|0.38|0.74|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression >= 1%||
1643809|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.6|||||2-Sided|95.0|0.42|0.84|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression < 1%||
1643810|NCT01844505|3021741|Superiority or Other (legacy)||Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.57|1.12|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression < 1%||
1643811|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.6|||||2-Sided|95.0|0.33|1.09|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression not evaluable at baseline||
1643812|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.51|||||2-Sided|95.0|0.3|0.89|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline||
1643813|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.86|||||2-Sided|95.0|0.49|1.52|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression not evaluable at baseline||
1643814|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.61|||||2-Sided|95.0|0.34|1.09|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression >= 10%||
1643815|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.28|||||2-Sided|95.0|0.16|0.49|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression >= 10%||
1643816|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.46|||||2-Sided|95.0|0.28|0.73|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression >= 10%||
1643817|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.63|1.01|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression < 10%||
1643818|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.43|||||2-Sided|95.0|0.34|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression < 10%||
1643819|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.54|||||2-Sided|95.0|0.43|0.67|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression < 10%||
1643820|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.87|||||2-Sided|95.0|0.54|1.38|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression >= 5%||
1643821|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.35|||||2-Sided|95.0|0.22|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression >= 5%||
1643822|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.4|||||2-Sided|95.0|0.27|0.6|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression >= 5%||
1643823|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.73|||||2-Sided|95.0|0.57|0.94|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression < 5%||
1643824|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.42|||||2-Sided|95.0|0.33|0.53|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression < 5%||
1643825|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.57|||||2-Sided|95.0|0.45|0.71|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression < 5%||
1643826|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.9|||||2-Sided|95.0|0.66|1.21|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression >= 1%||
1643827|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.4|||||2-Sided|95.0|0.3|0.53|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression >= 1%||
1643828|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.45|||||2-Sided|95.0|0.34|0.59|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression >= 1%||
1643829|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.63|||||2-Sided|95.0|0.45|0.87|||||HR of Nivolumab+Ipilimumab vs. Nivolumab in participants with PD-L1 expression < 1%||
1643830|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.39|||||2-Sided|95.0|0.28|0.54|||||HR of Nivolumab+Ipilimumab vs. Ipilimumab in participants with PD-L1 expression < 1%||
1643831|NCT01844505|3021742|Superiority or Other (legacy)||Hazard Ratio (HR)|0.63|||||2-Sided|95.0|0.46|0.85|||||HR of Nivolumab vs. Ipilimumab in participants with PD-L1 expression < 1%||
1643832|NCT01844505|3021743|Superiority or Other (legacy)||Difference of Objective Response Rates|13.8|||||2-Sided|95.0|6.3|21.3|||||Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Nivolumab.||
1643833|NCT01844505|3021743|Superiority or Other (legacy)||Odds Ratio (OR)|1.8|||||2-Sided|95.0|1.3|2.49|||||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Nivolumab||
1643834|NCT01844505|3021743|Superiority or Other (legacy)||Difference of Objective Response Rates|38.4|||||2-Sided|95.0|31.5|45.2|||||Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Ipilimumab.||
1643835|NCT01844505|3021743|Superiority or Other (legacy)||Difference of Objective Response Rates|24.7|||||2-Sided|95.0|17.9|31.5|||||Difference in ORR and corresponding 95% CI is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab - Ipilimumab.||
1643836|NCT01844505|3021743|Superiority or Other (legacy)||Odds Ratio (OR)|6.11|||<|0.0001|2-Sided|99.5|3.59|10.38|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Ipilimumab.||
1643837|NCT01844505|3021743|Superiority or Other (legacy)||Odds Ratio (OR)|3.4|||<|0.0001|2-Sided|99.5|2.02|5.72|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab over Ipilimumab.||
1643838|NCT01844505|3021744|Superiority or Other (legacy)||Hazard Ratio (HR)|0.88|||||2-Sided|95.0|0.69|1.12|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.||Median survival for the nivolumab arm was not estimable because the lower confidence limits for the survivor function are above 0.50. The p-value is calculated from a stratified log rank statistic which compares the survival distributions between the two treatment arms.
1644073|NCT01833403|3022897|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1643839|NCT01844505|3021745|Superiority or Other (legacy)||Hazard Ratio (HR)|0.74|||||2-Sided|95.0|0.6|0.92|||||Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab + Ipilimumab over Nivolumab.||
1643840|NCT01844505|3021748|Superiority or Other (legacy)||Hazard Ratio (HR)|0.55|||<|0.0001|2-Sided|98.0|0.42|0.72|||Log Rank|Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the IVRS.|Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.||Median survival for the nivolumab arm was not estimable because the lower confidence limits for the survivor function are above 0.50. The p-value is calculated from a stratified log rank statistic which compares the survival distributions between the two treatment arms.
1643841|NCT01844505|3021748|Superiority or Other (legacy)||Hazard Ratio (HR)|0.63|||<|0.0001|2-Sided|98.0|0.5|0.78|||Log Rank|Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the Interactive Voice Response System (IVRS).|Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipilimumab.||Median survival for the nivolumab arm was not estimable because the lower confidence limits for the survivor function are above 0.50. The p-value is calculated from a stratified log rank statistic which compares the survival distributions between the two treatment arms.
1643842|NCT01844505|3021749|Superiority or Other (legacy)||Hazard Ratio (HR)|0.42|||<|0.0001|2-Sided|99.5|0.31|0.57|||Stratified Log Rank test||Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.||
1643843|NCT01844505|3021749|Superiority or Other (legacy)||Hazard Ratio (HR)|0.57|||<|0.0001|2-Sided|99.5|0.43|0.76|||Stratified Log Rank test||Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipilimumab.||
1643844|NCT01844375|3021767|Equivalence|equivalence analysis||||||0.75|||||||Kruskal-Wallis||||
1643845|NCT01844115|3021873|Superiority||Least Squares Mean Difference|-1.89||||0.0236|2-Sided|95.0|-3.52|-0.26|||MMRM||||
1643846|NCT01844115|3021874|Superiority||Least Squares Mean Difference|-2.2||||0.0048|2-Sided|95.0|-3.72|-0.68|||MMRM||||
1643847|NCT01843972|3021878|Non-Inferiority or Equivalence|This was non-confirmatory testing.|Slope|1.0312|||||2-Sided|95.0|0.833|1.179|||||||
1643848|NCT01843972|3021878|Superiority or Other||Geometric mean ratio (net)|109.8|Standard Deviation|28.8|||2-Sided|90.0|84.376|142.894|||||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').|
1643849|NCT01843972|3021878|Superiority or Other||Geometric mean ratio (net)|95.48|Standard Deviation|30.8|||2-Sided|90.0|74.414|122.511|||||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.|
1643850|NCT01843972|3021879|Non-Inferiority or Equivalence|This was non-confirmatory testing.|Slope|0.9686|||||2-Sided|95.0|0.8107|1.1266||||||Dose proportionality of BI 691751 was explored using a power model (regression model applied to log-transformed data).|
1643851|NCT01843972|3021880|Non-Inferiority or Equivalence|This was non-confirmatory testing.|Slope|1.0233|||||2-Sided|95.0|0.8265|1.2201|||||||
1643852|NCT01843972|3021881|Superiority or Other||Geometric mean ratio (net)|92.69|Standard Deviation|33.0|||2-Sided|90.0|68.662|125.119|||||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').|
1643853|NCT01843972|3021881|Superiority or Other||Geometric mean ratio (net)|101.31|Standard Deviation|28.2|||2-Sided|90.0|80.593|127.351|||||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.|
1643854|NCT01843972|3021882|Superiority or Other||Geometric mean ratio (net)|111.2|Standard Deviation|24.7|||2-Sided|90.0|88.596|139.576|||||The geometric mean ratio was calculated as the geometric mean of the poor metabolisers divided by the geometric mean of the extensive metabolisers.|Comparison of poor metabolisers (5 (all) subjects of group 'BI 691751 tablet poor metabolizers (part II)') and extensive metabolisers (12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)').|
1643855|NCT01843972|3021882|Superiority or Other||Geometric mean ratio (net)|97.88|Standard Deviation|24.8|||2-Sided|90.0|79.963|119.809|||||The geometric mean ratio is calculated as the geometric mean of 'BI 691751 tablet extensive metabolizers (part II)' divided by the geometric mean of 'BI 691751 solution (part II)'.|Only extensive CYP2D6 metabolisers were selected: 12 (all) subjects of group 'BI 691751 tablet extensive metabolizers (part II)' and 7 (all investigated) subjects of group 'BI 691751 solution (part II) '.|
1643856|NCT01843842|3021887|Superiority|||||||0.4|||||||ANCOVA||||
1643857|NCT01843842|3021888|Superiority|||||||0.0364||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||All symptoms (Days 1-5, patient diary data)|
1643858|NCT01843842|3021888|Superiority|||||||0.2963|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Days 1-5, patient diary data)|
1643859|NCT01843842|3021888|Superiority|||||||0.0145||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Non-specific (Days 1-5, patient diary data)|
1643860|NCT01843842|3021888|Superiority|||||||0.0142||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Days 1-5, patient diary data)|
1643861|NCT01843842|3021888|Superiority|||||||0.2645|||||||Kruskal-Wallis|||All symptoms (Days 1, 3, 6 doctor's examination)|
1643862|NCT01843842|3021888|Superiority|||||||0.7227|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Days 1, 3, 6 doctor's examination)|
1643863|NCT01843842|3021888|Superiority|||||||0.082|||||||Kruskal-Wallis|||Non-specific (Days 1, 3, 6 doctor's examination)|
1643864|NCT01843842|3021888|Superiority|||||||0.0166||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Days 1, 3, 6 doctor's examination)|
1644074|NCT01832961|3022942|Other||||||<|0.05|||||||T-test||||
1643865|NCT01843842|3021889|Superiority|||||||0.356|||||||Kruskal-Wallis|||Duration of all acute respiratory infection symptoms (fever, non-specific symptoms and nasal/ throat/ chest symptoms) based on Patient Diary Data|
1643866|NCT01843842|3021889|Superiority|||||||0.4331|||||||Kruskal-Wallis|||Duration of nasal/ throat/ chest symptoms based on Patient Diary Data|
1643867|NCT01843842|3021889|Superiority|||||||0.5755|||||||Kruskal-Wallis|||Duration of non-specific symptoms based on Patient Diary Data|
1643868|NCT01843842|3021889|Superiority|||||||0.1158|||||||Kruskal-Wallis|||Duration of fever based on Patient Diary Data|
1643869|NCT01843842|3021890|Superiority|||||||0.244|||||||ANCOVA|||Severity of clinical manifestations of acute respiratory infection (ARI) by Total Symptom Score on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)|
1643870|NCT01843842|3021890|Superiority|||||||0.25|||||||Kruskal-Wallis|||All symptoms (Day 3, doctor's examination)|
1643871|NCT01843842|3021890|Superiority|||||||0.706|||||||Kruskal-Wallis|||Nasal/Throat/Chest (Day 3, doctor's examination)|
1643872|NCT01843842|3021890|Superiority|||||||0.3264|||||||Kruskal-Wallis|||Non-specific (Day 3, doctor's examination)|
1643873|NCT01843842|3021890|Superiority|||||||0.0283||||||p-value is not adjusted for multiple comparisons|Kruskal-Wallis|||Fever (Day 3, doctor's examination)|
1643874|NCT01843842|3021891|Superiority||||||>|0.05|||||||Fisher Exact||||
1643875|NCT01843842|3021892|Superiority||||||<|0.0001|||||||Mixed Models Analysis||||
1643876|NCT01843842|3021893|Superiority|||||||0.016|||||||Global Test Statistic|See O`Brien 1984, Pocock 1997.|||
1643877|NCT01843803|3021894|Superiority||||||<|0.05|||||||Chi-squared|||chi-square|
1643878|NCT01843803|3021895|Superiority||Odds Ratio (OR)|1.69||||0.065|2-Sided|95.0|0.99|2.86||P-Value derived after adjusting model provider clustering and treating it as a random effect.|Mixed Models Analysis|||Assessed whether a person in the intervention group vs the attention control group was more likely to be probed at least once by their provider after adjusting for other measures and accounting for the provider clustering.|
1643879|NCT01843803|3021897|Superiority||Mean Difference (Final Values)|2.7|Standard Error of the Mean|1.5||0.029|2-Sided|||||"P-Value = 0.029 after adjusting for clinical and demographic, and accounting for clustering of patients within providers.~Comparison of adjusted CARES score yielded a significant difference."|Mixed Models Analysis|A mixed model was ran with CARES as the dependent variable, adjusted for demographic and clinical measures , and provider as a random effect.||Mixed model adjusted for gender, race, education, marital status, mental health condition, substance disorder, COPD, heart failure, diabetes, coronary artery disease, study site and accounting for clustering of patients within providers.|
1643880|NCT01843673|3021907|Non-Inferiority or Equivalence|Statistical significance testing at 5% level of significance, p-value being larger than 0.05. Those are the p-values for pairwise comparison.||||||1||||||Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and ExacTrac was 1.00.|t-test, 2 sided|||Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.|
1643881|NCT01843673|3021907|Non-Inferiority or Equivalence|Statistical significance testing at 5% level of significance, p-value being larger than 0.05 . The p-values for pairwise comparison.||||||1||||||Statistical significance testing at 5% level of significance, p-value being larger than 0.05. The p-values for pairwise comparison lateral and vertical, for OBI and CBCT was 1.00.|t-test, 2 sided|||Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. Clinical significance is based on a 2 mm difference. Statistical significance is determined based on 5% level of significance.|
1643882|NCT01843374|3021941|Superiority or Other (legacy)||Hazard Ratio (HR)|0.81||||0.0325|2-Sided|95.0|0.68|0.98||Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.|Log Rank|Stratification factors were EORTC status and Line of therapy|Tremelimumab is the numerator and placebo, the denominator||
1643883|NCT01843374|3021942|Superiority or Other (legacy)||Hazard Ratio (HR)|1.011||||0.926|2-Sided|95.0|0.793|1.289||Estimated using the methods of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and line of therapy.|Log Rank||Tremelimumab is the numerator and Placebo the denominator||
1643884|NCT01843374|3021943|Superiority or Other (legacy)||Hazard Ratio (HR)|0.92||||0.4081|2-Sided|95.0|0.76|1.12||P-value was estimated using the method of Klein et al. 2007 and Whitehead and Whitehead 1991, stratified by EORTC status and Line of therapy.|Log Rank|The stratification factors included EORTC status and line of therapy as recorded in IVRS/IWRS.|Tremelimumab represents the numerator and Placebo the denominator|H0: No difference between tremelimumab and placebo H1: Difference between tremelimumab and placebo|
1643885|NCT01843348|3021949|Superiority or Other||Odds Ratio, log|0.028|||<|0.001|2-Sided|95.0|-0.032|0.087|||Pearson’s chi-square test|||BPAR - treatment differences at Month 12|
1643886|NCT01843348|3021953|Superiority or Other||Point estimate|0.149|||||2-Sided|95.0|0.076|0.221||||||CycA+Certican -Tac+MPA - difference between groups|
1643887|NCT01843348|3021953|Superiority or Other||Point estimate|0.032|||||2-Sided|95.0|-0.029|0.093||||||TAC+Certican - TAC+MPA - difference between groups|
1643888|NCT01843348|3021954|Non-Inferiority or Equivalence|The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin|Least squares mean|-5.56||||0.0067|2-Sided|95.0|-9.56|-1.55||Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)|ANOVA||||
1643907|NCT01841281|3022129|Other|||||||0.09||||||The p-value is for the interaction term|testing for interaction term|||The treatment effect was tested as an interaction term between treatment and FeNO. The null hypothesis is the effect of treatment is stratified by the FeNO status. We used a regression model instead of t-test or Wilcoxon signed-rank test in order to control period and carry-over effect which is common in a cross-over study design|
1643889|NCT01843348|3021954|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) with tx, center, donor type factors. Raw and adjusted means were presented with one-sided p-values for un-shifted and shifted hypothesis, respectively. Significance level = 2.5% (one-sided)|Least square mean|-9.35|||<|0.0001|2-Sided|95.0|-13.82|-4.88|||ANOVA|||The trial tests the null hypotheses that the treatment difference (investigational minus reference) in mean eGFR at re-assigned visit Month 12 is lower than the non-inferiority margin (Δ) of 7 mL/min per 1.73m2 versus the alternative that the treatment difference is equal to or greater than the non-inferiority margin|
1643890|NCT01843062|3021990|Superiority||Odds Ratio (OR)|0.85||||0.6549|2-Sided|95.0|0.42|1.73||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio >1 favours selumetinib in combination with RAI.|
1643891|NCT01843062|3021991|Superiority||Odds Ratio (OR)|1.07||||0.8205|2-Sided|95.0|0.61|1.87||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio >1 favours selumetinib in combination with RAI.|
1643892|NCT01843062|3021992|Superiority||Odds Ratio (OR)|0.85||||0.6549|2-Sided|95.0|0.42|1.73||P-value and CIs were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio >1 favours selumetinib in combination with RAI.|
1643893|NCT01843062|3021993|Superiority||Odds Ratio (OR)|1.07||||0.8205|2-Sided|95.0|0.61|1.87||The primary endpoint was to be considered statistically significant if the 2-sided p-value was less than 0.05. P-value and confidence intervals (CIs) were calculated using profile likelihood.|Regression, Logistic|||Selumetinib in combination with RAI was compared with placebo in combination with RAI. The analysis was performed using a logistic regression model including treatment as the only covariate. An odds ratio >1 favours selumetinib in combination with RAI.|
1643894|NCT01842958|3022000|Non-Inferiority|The test arm will be considered non-inferior to the control arm if the 95% upper confidence interval of the estimated difference between the test and control arms is less than -0.5mm.||||||0.02|||||||ANCOVA|||The primary efficacy endpoint is change in crestal bone level from loading to 12 months post-loading. The primary analysis is a test for non-inferiority of the test implant to the control implant at the one-sided 5% significance level. The null hypothesis is that µ3.3 ≥ µ4.1 + δ, where µ3.3 is the mean change in crestal bone level for the test implants, µ4.1 is the mean change in crestal bone level for control implants, and δ is a pre-specified clinically significant difference.|
1643895|NCT01842633|3022042|Superiority or Other||Treatment Difference|-0.47|||||2-Sided|95.0|-1.36|0.42|||||||
1643896|NCT01842620|3022046|Equivalence|Geometric means ratio for Cmax of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of Cmax)*100|98.34|||||2-Sided|90.0|88.54|109.22|||||Ratio of Cmax= (Cmax of Test) / (Cmax of Reference)|Overall period|
1643897|NCT01842620|3022047|Equivalence|Geometric means ratio for AUC(0-inf) of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of AUC0-inf)*100|99.02|||||2-Sided|90.0|92.26|106.27|||||Ratio of AUC0-inf= (AUC0-inf of Test) / (AUC 0-inf of Reference)|For overall period|
1643898|NCT01842620|3022048|Equivalence|Geometric means ratio for AUC (0-t) of test drug (Oxemet) to be entirely fallen within range of 0.80 to 1.25 of that of reference drug (Glafornil).|(Ratio of AUC0-36)*100|100.0|||||2-Sided|90.0|92.62|107.98|||||Ratio of AUC0-36= (AUC0-36 of Test)/ AUC 0-36 Reference)|Overall period|
1643899|NCT01842581|3022071|Superiority|2-sided test at a significance level of 0.05.|Hazard Ratio (HR)|1.739||||0.0985|2-Sided|95.0|0.894|3.382||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by analysis region. Hazard ratio estimate (hazard of breakthrough HE for rifaximin compared to rifaximin + lactulose) obtained from Cox proportional hazards model with effect for treatment, stratified by analysis region.|
1643900|NCT01842581|3022072|Non-Inferiority|Threshold for significance=upper bound of the 2-sided 95% confidence interval (CI) for hazard ratio less than (<) 1.56.|Hazard Ratio (HR)|1.959||||0.0359|2-Sided|95.0|1.045|3.672|||Score statistics|||Hazard ratio estimate (hazard of breakthrough HE for rifaximin compared to rifaximin + lactulose) obtained from Cox proportional hazards model with effect for treatment, stratified by analysis region.|
1643901|NCT01841697|3022095|Superiority or Other||Between-group rate difference|4.4||||0.212|2-Sided|95.0|-2.5|11.4|||Miettinen & Nurminen method|||Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.|
1643902|NCT01841697|3022096|Superiority or Other||Between-group rate difference|2.0||||0.619|2-Sided|95.0|-5.9|9.9|||Miettinen & Nurminen method|||Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.|
1643903|NCT01841697|3022097|Superiority or Other||Difference in least squares mean|-4.2||||0.089|2-Sided|95.0|-9.0|0.6|||Constrained logitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|Difference is omarigliptin minus sitagliptin.||
1643904|NCT01841697|3022098|Superiority or Other||Difference in percent|-1.3|||||2-Sided|95.0|-3.6|0.8|||||Difference is omarigliptin minus sitagliptin.||
1643905|NCT01841697|3022099|Superiority or Other||Difference in percent|-4.3|||||2-Sided|95.0|-11.8|3.2|||||Difference is omarigliptin minus sitagliptin.||
1643906|NCT01841697|3022100|Non-Inferiority or Equivalence|If the upper bound of the two-sided 95% confidence interval for the mean difference between omarigilptin and sitagliptin is less than the non-inferiority margin, δ =0.3%, then omarigliptin will be declared non-inferior to sitagliptin in terms of A1C reduction at Week 24.|Difference in least squares mean|-0.03|||||2-Sided|95.0|-0.15|0.08|||||Difference is omarigliptin minus sitagliptin.|Constrained longitudinal data analysis|
1643908|NCT01841281|3022130|Other|||||||0.78||||||The p-value is for the interaction term|testing for interaction term||||
1643909|NCT01841073|3022133|Superiority|||||||0.13|||||||ANCOVA||||
1643910|NCT01841073|3022134|Superiority|||||||0.027|||||||ANCOVA||||
1643911|NCT01841073|3022135|Superiority|||||||0.005||||||p-value was calculated, and is not attempting to indicate the threshold for statistical significance|ANCOVA||||
1643912|NCT01840410|3022178|Superiority or Other||Mean Difference (Net)|9.94|Standard Error of the Mean|1.502|<|0.001|2-Sided|95.0|6.97|12.91|||Mixed Models Analysis||||
1643913|NCT01840228|3022188|Superiority|||||||0.73|||||||Wilcoxon (Mann-Whitney)||||
1643914|NCT01840228|3022189|Superiority||Risk Ratio (RR)|1.5||||0.71|2-Sided|95.0|0.51|4.43|||Fisher Exact||||
1643915|NCT01840228|3022190|Superiority||Risk Ratio (RR)|0.43||||0.13|2-Sided|95.0|0.14|1.36|||Fisher Exact||||
1643916|NCT01840228|3022191|Superiority||Risk Ratio (RR)|1.1||||0.74|2-Sided|95.0|0.63|1.91|||Chi-squared||||
1643917|NCT01839708|3022215|Other||||||<|0.05|||||||Mixed Models Analysis||||
1643918|NCT01839708|3022216|Other||||||<|0.05|||||||Mixed Models Analysis||||
1643919|NCT01839708|3022217|Other||||||<|0.05|||||||Mixed Models Analysis||||
1643920|NCT01839708|3022218|Other||||||<|0.05|||||||Mixed Models Analysis||||
1643921|NCT01839708|3022219|Other||||||<|0.05|||||||Mixed Models Analysis||||
1643922|NCT01839708|3022220|Other||||||<|0.05|||||||Mixed Models Analysis||||
1643923|NCT01839708|3022221|Other||||||<|0.05|||||||Mixed Models Analysis||||
1643924|NCT01839708|3022222|Other||||||<|0.05|||||||Mixed Models Analysis||||
1643925|NCT01839708|3022223|Other|||||||0.03|||||||Mixed Models Analysis||||
1643926|NCT01839708|3022224|Other||||||<|0.05|||||||Mixed Models Analysis||||
1643927|NCT01839708|3022225|Other||||||>|0.05|||||||Mixed Models Analysis||||
1643928|NCT01839708|3022226|Other||||||<|0.05|||||||Mixed Models Analysis||||
1643929|NCT01839708|3022227|Other||||||>|0.05|||||||Mixed Models Analysis||||
1643930|NCT01839708|3022228|Other||||||>|0.05|||||||Mixed Models Analysis||||
1643931|NCT01838681|3022351|Superiority||Odds Ratio (OR)|0.83||||0.2641|2-Sided|95.0|0.6|1.15|||Regression, Logistic|Model included MADRS total score at the randomisation visit, treatment group, country, and the randomisation criteria used|||
1643932|NCT01838499|3022461|Superiority or Other||Change from baseline (at week 12)|-0.03||||0.945|2-Sided|80.0|-0.63|0.57|||ANCOVA||MEDI8968 - Placebo|Analysis of change from baseline (Week 12) estimated from ANCOVA model with tmt group and PGA stratum at randomisation included in the model and average daily pain at baseline as a covariate|
1643933|NCT01838499|3022462|Superiority or Other||Difference in proportions|-0.065|||>|0.05|2-Sided|80.0|-0.205|0.076|||Mixed Models Analysis|||Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.|
1643934|NCT01838499|3022463|Superiority or Other||Difference in proportions|0.051|||>|0.05|2-Sided|80.0|-0.067|0.169|||Mixed Models Analysis||MEDI8968 - placebo|Analysis of proportion of Responders for Physician’s Global Assessment (PGA score 0, 1 or 2) at Week 12 - LOCF. Difference in proportions MEDI8968 - placebo. Wald asymptotic confidence limits calculated.|
1643935|NCT01838304|3022472|Other||Odds Ratio (OR)|7.9|||<|0.0001|2-Sided|95.0|4.21|14.81|||Fisher Exact|||Fisher's exact test for odd's ratio of time below a saturation of 80% to total time|
1643936|NCT01838226|3022475|Superiority||Mean Difference (Net)|-2.6|||||2-Sided|95.0|-4.9|-0.2|||||||
1643937|NCT01838226|3022476|Superiority||Mean Difference (Net)|0.9|||||2-Sided|95.0|-1.3|3.1|||||||
1643938|NCT01838226|3022477|Superiority||Mean Difference (Final Values)|0.7||||0.5|2-Sided|95.0|-1.3|2.8|||Mixed Models Analysis||||
1643939|NCT01838044|3022491|Superiority or Other||LS Mean Difference|-0.31|Standard Error of the Mean|0.363||0.3987|2-Sided|95.0|-1.02|0.41|||Mixed Models Analysis|||Statistical analysis at Week 10 compared between treatment groups.|
1643940|NCT01838044|3022491|Superiority or Other||LS Mean Difference|-0.34|Standard Error of the Mean|0.317||0.2856|2-Sided|95.0|-0.97|0.29|||Mixed Models Analysis|||Statistical analysis at Week 5 compared between treatment groups.|
1643941|NCT01838044|3022493|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|0.13||0.1255|2-Sided|95.0|-0.06|0.46|||Mixed Models Analysis|||Statistical analysis at Week 10 based on comparison between treatment groups.|
1643942|NCT01838044|3022493|Superiority or Other||LS Mean Difference|0.05|Standard Error of the Mean|0.14||0.7251|2-Sided|95.0|-0.22|0.32|||Mixed Models Analysis|||Statistical analysis at Week 5 based on comparison between treatment groups.|
1643943|NCT01838044|3022495|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.361||0.5128|2-Sided|95.0|-0.48|0.95|||Mixed Models Analysis|||Statistical analysis of weekly mean pain NRS score in Arm B compared between two study arms at Week 10.|
1643944|NCT01838044|3022496|Superiority or Other||Mean Difference (Final Values)|1.42|||<|0.0001|2-Sided|95.0|1.02|1.83|||Mixed Models Analysis|||Statistical analysis of weekly mean pain NRS score in Arm B at Week 10.|
1643945|NCT01838044|3022497|Superiority or Other||LS Mean Difference|-0.15|Standard Error of the Mean|0.287||0.6012|2-Sided|95.0|-0.72|0.42|||Mixed Models Analysis|||Statistical analysis at Week 5 compared between two study arms.|
1643946|NCT01837823|3022510|Superiority or Other||Pearson correlation coefficient|0.074||||0.5|2-Sided||||||Pearson correlation coefficient|||for minimum lumen area site|
1643947|NCT01837823|3022511|Superiority or Other||Pearson correlation coefficient|-0.231||||0.054|2-Sided||||||Regression, Linear||||
1643948|NCT01837719|3022526|Superiority or Other||Geometric mean ratio|0.904|||||2-Sided|90.0|0.836|0.978|||||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and light meal on the natural logarithms of exposure of atazanavir when given as an FDC|
1643949|NCT01837719|3022526|Superiority or Other||Geometric mean ratio|1.116|||||2-Sided|90.0|1.012|1.231|||||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and fasted on the natural logarithms of exposure of cobicistat when given as an FDC.|
1643950|NCT01837719|3022526|Superiority or Other||Geometric mean ratio|0.976|||||2-Sided|90.0|0.886|1.075|||||Geometric mean ratio of AUC(INF) was calculated as Treatment D/Treatment C|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(INF) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.|
1643951|NCT01837719|3022526|Superiority or Other||Geometric mean ratio|1.24|||||2-Sided|90.0|1.148|1.34|||||Geometric mean ratio of AUC(INF) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC|
1643952|NCT01837719|3022526|Non-Inferiority or Equivalence|Bioequivalence was concluded if the 90% CI for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T), and AUC(INF).|Geometric mean ratio|1.019|||||2-Sided|90.0|0.982|1.058|||||Geometric mean ratio of AUC(INF) was calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF), with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.|
1643953|NCT01837719|3022526|Superiority or Other||Geometric mean ratio|0.89|||||2-Sided|90.0|0.825|0.96|||||Geometric mean ratio of AUC(0-T) was calculated asTreatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and a light meal on the natural logarithms of exposure of cobicistat when given as an FDC|
1643954|NCT01837719|3022526|Superiority or Other||Geometric mean ratio|1.127||||||90.0|1.017|1.248|||||Geometric mean ratio of AUC(0-T) was calculated asTreatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC.|
1643955|NCT01837719|3022526|Superiority or Other||Geometric mean ratio|1.102|||||2-Sided|90.0|0.929|1.307|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment D/Treatment C|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.|
1643956|NCT01837719|3022526|Superiority or Other||Geometric mean ratio|1.232||||||90.0|1.141|1.331|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when given as an FDC|
1643957|NCT01837719|3022526|Superiority or Other||Geometric mean ratio|1.019|||||2-Sided|90.0|0.983|1.057|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment B/Treatment A|A linear mixed-effect model was applied to the natural logarithms of cobicistat AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.|
1643958|NCT01837719|3022528|Superiority or Other||Geometric mean ratio|0.784|||||2-Sided|90.0|0.717|0.858|||||Geometric mean ratio was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.|
1643959|NCT01837719|3022528|Superiority or Other||Geometric mean ratio|1.04|||||2-Sided|90.0|0.937|1.154|||||Geometric mean ratio was calculated asTreatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.|
1643960|NCT01837719|3022528|Superiority or Other||Geometric mean ratio|1.085|||||2-Sided|90.0|0.925|1.273|||||Geometric mean ratio was calculated as Treatment D/Treatment C|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir cobicistat|
1643961|NCT01837719|3022528|Superiority or Other||Geometric mean ratio|1.305|||||2-Sided|90.0|1.215|1.402|||||Geometric mean ratio was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.|
1643962|NCT01837719|3022528|Superiority or Other||Geometric mean ratio|1.023|||||2-Sided|90.0|0.991|1.057|||||Geometric mean ratio was calculated as Treatment B/Treatment A|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of cobicistat when administered as a fixed-dose combination.|
1643963|NCT01837719|3022530|Superiority or Other||Geometric mean ratio|0.912||||||90.0|0.789|1.054|||||Geometric mean ratio was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.|
1643964|NCT01837719|3022530|Superiority or Other||Geometric mean ratio|1.231|||||2-Sided|90.0|1.023|1.483|||||Geometric mean ratio was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.|
1643965|NCT01837719|3022530|Superiority or Other||Geometric mean ratio|1.144||||||90.0|1.006|1.3|||||Geometric mean ratio was calculated as Treatment D/Treatment C|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as an FDC|
1643966|NCT01837719|3022530|Superiority or Other||Geometric mean ratio|1.349|||||2-Sided|90.0|1.215|1.498|||||Geometric mean ratio of C24 was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.|
1643967|NCT01837719|3022530|Superiority or Other||Geometric mean ratio|1.084|||||2-Sided|90.0|1.014|1.158|||||Geometric mean ratio was calculated as Treatment B/Treatment A|A linear mixed-effect model with treatment as fixed effect and patient as random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as a fixed-dose combination.|
1643968|NCT01837719|3022535|Superiority or Other||Geometric mean ratio|0.749|||||2-Sided|90.0|0.658|0.852|||||Geometric mean ratio of AUC(INF) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and participant as a random effect was used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when administered as an FDC.|
1643969|NCT01837719|3022535|Superiority or Other||Geometric mean ratio|0.956|||||2-Sided|90.0|0.81|1.128|||||Geometric mean of AUC(INF) was calculated as Treatment E/Treatment D||
1643970|NCT01837719|3022535|Superiority or Other||Geometric mean ratio|1.11|||||2-Sided|90.0|0.991|1.244|||||Geometric mean ratio of AUC(INF) was calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect|
1643971|NCT01837719|3022535|Superiority or Other||Geometric mean ratio|1.28|||||2-Sided|90.0|1.171|1.398|||||Geometric mean ratio for AUC(INF) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and participant as a random effect was used to estimate the effect of a light meal and fthe fasted state on the natural logarithms of exposure of atazanavir when given as an FDC|
1643972|NCT01837719|3022535|Non-Inferiority or Equivalence|Bioequivalence was concluded if the 90% confidence intervals for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T) and AUC(INF).|Geometric mean ratio|1.064||||||90.0|1.011|1.12|||||Geometric mean ration for AUC(INF) is calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-INF), with treatment period and sequence as fixed effects, and patient (sequence) as a random effect.|
1643973|NCT01837719|3022535|Superiority or Other||Geometric mean ratio|0.746|||||2-Sided|90.0|0.655|0.849|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effect and participant as a random effect will be used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when given as an FDC|
1643974|NCT01837719|3022535|Superiority or Other||Geometric mean ratio|0.95|||||2-Sided|90.0|0.804|1.122|||||Geometric mean ratio of AUC(0-T) was calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effect and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC.|
1643975|NCT01837719|3022535|Superiority or Other||Geometric mean ratio|1.113|||||2-Sided|90.0|0.993|1.248|||||Geometric mean ratio for AUC(0-T) is calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-T) with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect|
1643976|NCT01837719|3022535|Superiority or Other||Geometric mean ratio|1.275|||||2-Sided|90.0|1.166|1.393|||||Geometric mean ratio for AUC(0-T) was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effect and patient as a random effect was used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when administered as an FDC|
1643977|NCT01837719|3022535|Non-Inferiority or Equivalence|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir AUC(0-T), with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.|Geometric mean ratio|1.065|||||2-Sided|90.0|1.012|1.12|||||Geometric mean ratio for AUC(0-T) is calculated as Treatment B/Treatment A|Bioequivalence was concluded if the 90% confidence intervals for the ratios of geometric means of the test formulation (FDC tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, AUC(0-T) and AUC(INF).|
1643978|NCT01837719|3022536|Superiority or Other||Geometric mean ratio|0.643|||||2-Sided|90.0|0.545|0.759|||||Geometric mean ratio is calculated as Treatment E/Treatment B|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of high fat and light meals on the natural logarithms of exposure of atazanavir when given as an FDC|
1643979|NCT01837719|3022536|Superiority or Other||Geometric mean ratio|0.862|||||2-Sided|90.0|0.701|1.059|||||Geometric mean ratio is calculated as Treatment E/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a high fat meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC|
1643980|NCT01837719|3022536|Superiority or Other||Geometric mean ratio|1.137|||||2-Sided|90.0|1.0|1.292|||||Geometric mean ratio is calculated as Treatment D/Treatment C|To assess the relative bioavailability of atazanavir under fasted (Treatment D) versus fed (Treatment C) states, a linear mixed-effects model was applied to the natural logarithms of atazanavir Cmax with treatment, period, and sequence as fixed effects and participant (sequence) as a random effect.|
1643981|NCT01837719|3022536|Superiority or Other||Geometric mean ratio|1.423|||||2-Sided|90.0|1.273|1.59|||||Geometric mean ratio was calculated as Treatment B/Treatment D|A linear mixed-effect model with treatment as fixed effects and participant as a random effect will be used to estimate the effect of a light meal and the fasted state on the natural logarithms of exposure of atazanavir when given as an FDC|
1643982|NCT01837719|3022536|Non-Inferiority or Equivalence|Bioequivalence was concluded if the 90% CI for the ratios of geometric means of the test formulation (fixed-dose combination [FDC] tablet of 300/150 mg atazanavir/cobicistat) to the reference formulation (300-mg atazanavir capsule coadministered with 150-mg cobicistat) were contained within 0.80 to 1.25 for atazanavir Cmax, area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC[0-T]) and AUC from time 0 to infinity. (AUC[0-T])|Geometric mean ratio|1.073|||||2-Sided|90.0|1.012|1.137|||||Geometric mean ratio is calculated as Treatment B/Treatment A|To demonstrate bioequivalence for atazanavir between the test (Treatment B) and reference (Treatment A) formulations, a linear mixed-effects model was applied to the natural logarithms of atazanavir Cmax, with treatment, period, and sequence as fixed effects, and participant (sequence) as a random effect.|
1643983|NCT01837550|3022558|Non-Inferiority or Equivalence|To ensure a between-group effect of 80% at the 5% significance level it was estimated that 60 participants need to be included in the study. An effect size of Cohen’s d=0.80 was expected. The expected standardized mean difference on the HHIE formed the basis for the obtained power.||||||0.685|||||||Mixed Models Analysis||||
1643984|NCT01836523|3022577|Superiority or Other||Rate ratio|1.17||||0.1079|2-Sided|95.0|0.97|1.43|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).|
1643985|NCT01836523|3022577|Superiority or Other||Rate ratio|1.27||||0.0219|2-Sided|95.0|1.03|1.55|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).|
1643986|NCT01836523|3022577|Superiority or Other||Rate ratio|1.31||||0.0081|2-Sided|95.0|1.07|1.59|||Negative binomial regression|||The endpoint was analysed using a negative binomial regression model with a log-link function and the log of the time period in which an occurrence of a hypoglycaemic episode was considered treatment emergent as offset. The model included fixed factors (treatment, country, stratification group) and a covariate (baseline HbA1c).|
1643987|NCT01836523|3022578|Superiority or Other||Treatment ratio|1.0||||0.9615|2-Sided|95.0|0.96|1.04|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c < 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and >27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis|
1643988|NCT01836523|3022578|Superiority or Other||Treatment ratio|0.95||||0.0148|2-Sided|95.0|0.91|0.99|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c < 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and >27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis|
1643989|NCT01836523|3022578|Superiority or Other||Treatment ratio|0.92|||<|0.0001|2-Sided|95.0|0.88|0.96|||Mixed Models Analysis|||Analysis was done using MMRMs where all post-baseline measurements for specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as dependent variable, and visit, treatment, country and stratification variable (4 levels: HbA1c < 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and >27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate. The measurements were log-transformed before analysis|
1643990|NCT01836523|3022579|Superiority or Other||Treatment difference|-2.19|||<|0.0001|2-Sided|95.0|-2.91|-1.47|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c < 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and >27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.|
1643991|NCT01836523|3022579|Superiority or Other||Treatment difference|-3.55|||<|0.0001|2-Sided|95.0|-4.29|-2.81|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c < 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and >27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.|
1643992|NCT01836523|3022579|Superiority or Other||Treatment difference|-4.9|||<|0.0001|2-Sided|95.0|-5.65|-4.16|||Mixed Models Analysis|||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c < 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and >27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.|
1643993|NCT01836523|3022580|Non-Inferiority or Equivalence|Non-inferiority was concluded if the upper bound of 95% confidence interval was <0.3.|Treatment difference|-0.09|||||2-Sided|95.0|-0.21|0.03||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c < 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and >27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.|
1643994|NCT01836523|3022580|Non-Inferiority or Equivalence|Non-inferiority was concluded if the upper bound of 95% confidence interval was <0.3.|Treatment difference|-0.15|||||2-Sided|95.0|-0.27|-0.03||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c < 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and >27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.|
1643995|NCT01836523|3022580|Non-Inferiority or Equivalence|Non-inferiority was concluded if the upper bound of 95% confidence interval was <0.3.|Treatment difference|-0.2|||||2-Sided|95.0|-0.32|-0.07||||||Analysis was performed using MMRMs where all post-baseline measurements for the specific variable from planned visits up to week 52 and obtained no later than 1 day after withdrawal from treatment were entered as the dependent variable, and visit, treatment, country and the stratification variable (4 levels: HbA1c < 8.5% and ≥8.5%, each intersected by BMI≤27 kg/m2 and >27 kg/m2) were included as fixed factors and the corresponding baseline value as covariate.|
1643996|NCT01836471|3022581|Superiority or Other|||||||0.793|||||||Mixed Models Analysis||||
1643998|NCT01836471|3022582|Superiority or Other||least squares mean|0.1|Standard Error of the Mean|0.134|||2-Sided|95.0|-0.16|0.37|||||||
1643999|NCT01836471|3022582|Superiority or Other||least sqares mean|-0.07|Standard Error of the Mean|0.128|||2-Sided|95.0|-0.32|0.19|||||||
1644000|NCT01836471|3022582|Superiority or Other||least squares mean|-0.02|Standard Error of the Mean|0.098|||2-Sided|95.0|-0.22|0.17|||||||
1644001|NCT01836471|3022583|Superiority or Other|||||||0.9179|||||||Mixed Models Analysis||||
1644002|NCT01836471|3022584|Superiority or Other||least squares mean|-0.04|Standard Error of the Mean|0.053|||2-Sided|90.0|-0.13|0.05|||||||
1644003|NCT01836471|3022584|Superiority or Other||least squares mean|0.04|Standard Error of the Mean|0.054|||2-Sided|90.0|-0.04|0.13|||||||
1644004|NCT01836471|3022584|Superiority or Other||least sqares mean|0.01|Standard Error of the Mean|0.05|||2-Sided|90.0|-0.08|0.09|||||||
1644005|NCT01836471|3022585|Superiority or Other||least squares mean|0.01|Standard Error of the Mean|0.038||0.7269|2-Sided|90.0|-0.5|0.08|||Mixed Models Analysis||||
1644006|NCT01836445|3022598|Superiority|||||||0.719|||||||Regression, Linear||||
1644007|NCT01836445|3022599|Superiority|||||||0.953|||||||Regression, Linear|||Analysis for HIV Testing items|
1644008|NCT01836445|3022599|Superiority|||||||0.837|||||||Regression, Linear|||Analysis for Condom Use items|
1644009|NCT01836445|3022599|Superiority|||||||0.036|||||||Regression, Linear|||Analysis for Relationship Maintenance items|
1644010|NCT01836445|3022600|Superiority|||||||0.57|||||||Regression, Linear|||Analysis for Behavioral Skills items|
1644011|NCT01836445|3022600|Superiority|||||||0.617|||||||Regression, Linear|||Analysis for Social Norm items|
1644012|NCT01836445|3022600|Superiority|||||||0.043|||||||Regression, Linear|||Analysis for Motivation items|
1644013|NCT01836445|3022601|Other|Generalized Linear Mixed Model statistical test used||||||0.762|||||||Regression, Linear||||
1644014|NCT01836445|3022602|Other|Generalized Linear Mixed Model statistical test used||||||0.862|||||||Regression, Linear||||
1644015|NCT01836445|3022603|Other|Generalized Linear Mixed Model statistical test used||||||0.637|||||||Regression, Linear|||Analysis for HIV Testing items|
1644016|NCT01836445|3022603|Other|Generalized Linear Mixed Model statistical test used||||||0.067|||||||Regression, Linear|||Analysis for Condom Use items|
1644017|NCT01836445|3022603|Other|Generalized Linear Mixed Model statistical test used||||||0.001|||||||Regression, Linear|||Analysis for Relationship Maintenance items|
1644018|NCT01836445|3022604|Other|Generalized Linear Mixed Model statistical test used||||||0.151|||||||Regression, Linear|||Analysis for behavioral skills items|
1644019|NCT01836445|3022604|Other|Generalized Linear Mixed Model statistical test used||||||0.628|||||||Regression, Linear|||Analysis for social norms items|
1644020|NCT01836445|3022604|Other|Generalized Linear Mixed Model statistical test used||||||0.861|||||||Regression, Linear|||Analysis for motivation items|
1644021|NCT01836445|3022605|Other|Generalized Linear Mixed Model statistical test used||||||0.567|||||||Regression, Linear||||
1644022|NCT01836445|3022606|Other|Generalized Linear Mixed Model statistical test used||||||0.173|||||||Regression, Linear||||
1644023|NCT01836445|3022607|Other|Generalized Linear Mixed Model statistical test used||||||0.138|||||||Regression, Logistic||||
1644024|NCT01836445|3022608|Other|Generalized Linear Mixed Model statistical test used||||||0.025|||||||Regression, Linear|||Analysis for HIV Testing items|
1644025|NCT01836445|3022608|Other|Generalized Linear Mixed Model statistical test used||||||0.135|||||||Regression, Linear|||Analysis for Condom Use items|
1644026|NCT01836445|3022608|Other|Generalized Linear Mixed Model statistical test used||||||0.067|||||||Regression, Linear|||Analysis for Relationship Maintenance items|
1644027|NCT01836445|3022609|Other|Generalized Linear Mixed Model statistical test used||||||0.002|||||||Regression, Linear|||Analysis for Behavioral Skills items|
1644028|NCT01836445|3022609|Other|Generalized Linear Mixed Model statistical test used||||||0.493|||||||Regression, Linear|||Analysis for Social Norms items|
1644029|NCT01836445|3022609|Other|Generalized Linear Mixed Model statistical test used||||||0.919|||||||Regression, Linear|||Analysis for Motivation items|
1644030|NCT01836445|3022610|Other|Generalized Linear Mixed Model statistical test used||||||0.374|||||||Regression, Linear||||
1644031|NCT01836445|3022611|Other|Generalized Linear Mixed Model statistical test used||||||0.15|||||||Regression, Linear||||
1644032|NCT01836445|3022612|Superiority||Risk Ratio (RR)|0.6||||0.01|2-Sided|95.0|0.38|0.95|||Z-test||||
1644033|NCT01836445|3022614|Superiority||Prevalence Ratio|0.83||||0.04|2-Sided|95.0|0.7|0.99|||Regression, Logistic||||
1644034|NCT01836445|3022615|Superiority||Prevalence Ratio|0.95||||0.6|2-Sided|95.0|0.8|1.14|||Regression, Logistic||||
1644035|NCT01836445|3022616|Superiority||Prevalence Ratio|0.9||||0.2|2-Sided|95.0|0.76|1.06|||Regression, Logistic||||
1644036|NCT01836029|3022627|Superiority or Other (legacy)|||||||0.536||||||p-values are from Cochran-Mantel-Haenszel tests controlling for randomization stratification factors and comparing tumor response rates between the treatment groups.|Cochran-Mantel-Haenszel||||
1644037|NCT01836029|3022628|Superiority or Other (legacy)||Hazard Ratio (HR)|0.95||||0.399|1-Sided|90.0||1.22||The 1-sided p-value based on a log-rank test stratified by randomization stratification factors.|Log Rank||||
1644038|NCT01836029|3022630|Superiority or Other (legacy)||Hazard Ratio (HR)|0.99||||0.266|1-Sided|90.0||1.22||The 1-sided p-value based on a log-rank test stratified by randomization stratification factors.|Log Rank||||
1644039|NCT01835756|3022641|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1644040|NCT01835756|3022642|Superiority or Other||||||<|1e-05|||||||t-test, 2 sided||||
1644041|NCT01835743|3022643|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|t-test for two independent samples to compare the change in VAS scores across the evaluation period between the two procedure administration groups|||
1644042|NCT01835743|3022644|Superiority or Other||||||<|5e-05|||||||Fisher Exact||||
1644043|NCT01835548|3022667|Superiority||Least Square Mean Difference|-11.04|Standard Error of the Mean|1.4239|<|0.0001|2-Sided|95.0|-13.9|-8.2|||ANCOVA||||
1644044|NCT01835158|3022692|Superiority||Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.5|1.26|||||||
1644045|NCT01835158|3022693|Superiority||Hazard Ratio (HR)|0.66||||0.012|2-Sided|95.0|0.46|0.95|||Log Rank||||
1644046|NCT01835145|3022700|Superiority|||||||0.7|||||||Chi-squared|||A one-sided chi-squared test for a difference in PFS4 rates will be used to test for a difference between arms.|
1644047|NCT01834729|3022751|Superiority|||||||0.57|||||||Least squares means||||
1644048|NCT01834729|3022752|Superiority|||||||0.78|||||||Least squares means||||
1644049|NCT01834404|3022762|Superiority or Other|||||||0.26|||||||Wilcoxon (Mann-Whitney)||||
1644050|NCT01834404|3022763|Superiority or Other|||||||0.54|||||||Wilcoxon (Mann-Whitney)||||
1644051|NCT01834404|3022764|Superiority or Other|||||||0.9|||||||ANCOVA||||
1644052|NCT01834404|3022765|Superiority or Other|||||||0.72|||||||ANCOVA||||
1644053|NCT01834404|3022766|Superiority or Other|||||||0.35|||||||ANCOVA||||
1644054|NCT01834404|3022767|Superiority or Other|||||||0.03|||||||ANCOVA|||This p-value was based on a rank transformation.|
1644055|NCT01834404|3022768|Superiority or Other|||||||0.032|||||||ANCOVA||||
1644056|NCT01834404|3022769|Superiority or Other|||||||0.22|||||||ANCOVA||||
1644057|NCT01834404|3022770|Superiority or Other|||||||0.45|||||||ANCOVA||||
1644058|NCT01834404|3022771|Superiority or Other|||||||0.99|||||||ANCOVA||||
1644059|NCT01834404|3022772|Superiority or Other|||||||0.36|||||||ANCOVA||||
1644060|NCT01834404|3022773|Superiority or Other|||||||0.052|||||||ANCOVA||||
1644061|NCT01834404|3022774|Superiority or Other|||||||0.057|||||||ANCOVA||||
1644062|NCT01833897|3022822|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1644063|NCT01833897|3022823|Superiority or Other|||||||0.011|||||||ANOVA||||
1644064|NCT01833897|3022824|Superiority or Other|||||||0.026|||||||ANOVA||||
1644065|NCT01833897|3022825|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1644066|NCT01833897|3022826|Superiority or Other||||||<|0.001||||||F1,6.4=161.8,|linear mixed model||||
1644067|NCT01833533|3022883|Non-Inferiority or Equivalence|Noninferiority of the rate of sustained virologic response at 12 weeks after treatment in the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% CI (calculated using normal approximation to the binomial distribution)for the difference in percentage of participants must exceed -10.5% to achieve noninferiority.|Difference in Percentage of Participants|-6.8|||||2-Sided|95.0|-12.0|-1.5|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides >95% power to demonstrate noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV arm compared with the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (normal approximation of a single binomial proportion in a one-sample test for superiority).|
1644068|NCT01833533|3022883|Superiority or Other||Percentage of Participants|90.2|||||2-Sided|95.0|86.2|94.3|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides >90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).|
1644069|NCT01833533|3022883|Superiority or Other||Percentage of Participants|97.0|||||2-Sided|95.0|93.7|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides >90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).|
1644070|NCT01833533|3022884|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1644071|NCT01833533|3022885|Non-Inferiority or Equivalence|The noninferiority of the rate of sustained virologic response at 12 weeks for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN–RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.|Percentage of Participants|97.0|||||2-Sided|95.0|93.7|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides >95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).|
1644072|NCT01833533|3022885|Non-Inferiority or Equivalence|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN–RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.|Percentage of Participants|90.2|||||2-Sided|95.0|86.2|94.3|||||95% CI was calculated using the normal approximation to the binomial distribution.|Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides >95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).|
1644075|NCT01832961|3022943|Other||||||<|0.05|||||||T-test|T-test was used to comparisons before and after FeNO results|||
1644076|NCT01832961|3022944|Other||||||<|0.05|||||||Friedman's Test|||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)
1644077|NCT01832961|3022945|Other||||||<|0.05|||||||Friedman's Test|||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)
1644078|NCT01832961|3022946|Other||||||<|0.05|||||||Friedman's Test|Friedman's test followed by Dunn's multiple comparison||The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test|The effect of size used to calculate responsiveness and classified as small (0.2), moderate (0.5) and large (0.8).
1644079|NCT01832818|3022951|Superiority||||||<|0.05|||||||ANOVA||||
1644080|NCT01832818|3022952|Superiority||||||<|0.05|||||||ANOVA||||
1644081|NCT01832259|3022987|Superiority|||||||0.46|||||||Log Rank||||
1644082|NCT01832259|3022989|Superiority|||||||0.345|||||||t-test, 1 sided||||
1644083|NCT01832090|3023004|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1644084|NCT01832090|3023005|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1644085|NCT01832090|3023008|Superiority or Other||||||>|0.05|||||||Fisher Exact||||
1644086|NCT01832090|3023009|Superiority or Other||||||>|0.05|||||||Fisher Exact||||
1644087|NCT01832090|3023010|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1644088|NCT01832090|3023011|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1644089|NCT01832090|3023012|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1644090|NCT01832090|3023013|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1644091|NCT01831856|3023027|Superiority||Hazard Ratio (HR)|1.14||||0.5749|2-Sided|95.0|0.71|1.85|||Log Rank|||The primary criterion, time to first Atrial Fibrillation (AF) recurrence or atrial flutter emergence, was described using survival curves according to the Kaplan-Meier method, reporting the first and third quartiles (Q1, Q3), median, and 95% confidence interval. The time to first AF recurrence or atrial flutter emergence was compared between treatment groups using the Log rank test. Hazard ratios and 95% confidence intervals were estimated with the Cox regression model.|
1644092|NCT01831817|3023030|Superiority or Other||Mean change difference|-0.03||||0.9413|2-Sided|95.0|-0.9|0.84|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment||
1644093|NCT01831817|3023030|Superiority or Other||Mean change difference|1.46||||0.0011|2-Sided|95.0|0.59|2.33|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment||
1644094|NCT01831817|3023030|Superiority or Other||Mean change diference|1.43||||0.0016|2-Sided|95.0|0.56|2.31|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment||
1644095|NCT01831817|3023030|Superiority or Other||Mean change difference|-1.27||||0.0056|2-Sided|95.0|-2.16|-0.38|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment||
1644096|NCT01831817|3023030|Superiority or Other||Mean change difference|-1.24||||0.0072|2-Sided|95.0|-2.14|-0.34|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment||
1644097|NCT01831817|3023030|Superiority or Other||Mean change difference|0.19||||0.6727|2-Sided|95.0|-0.71|1.1|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment||
1644098|NCT01831817|3023031|Superiority or Other||Mean change difference|-0.7||||0.0734|2-Sided|95.0|-1.47|0.07|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment||
1644099|NCT01831817|3023031|Superiority or Other||Mean change difference|0.53||||0.1788|2-Sided|95.0|-0.24|1.3|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment||
1644100|NCT01831817|3023031|Superiority or Other||Mean change difference|-0.18||||0.6562|2-Sided|95.0|-0.95|0.6|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment||
1644101|NCT01831817|3023031|Superiority or Other||Mean change difference|-0.76||||0.0562|2-Sided|95.0|-1.55|0.02|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment||
1644102|NCT01831817|3023031|Superiority or Other||Mean change difference|-0.06||||0.8769|2-Sided|95.0|-0.86|0.73|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment||
1644103|NCT01831817|3023031|Superiority or Other||Mean change difference|-0.24||||0.5555|2-Sided|95.0|-1.03|0.56|||ANCOVA||Treatment as fixed factor. Baseline Schiff strata and VRS as covariates. Difference is 1st named treatment - 2nd named treatment that a negative difference implies the mean of the 2nd named treatment is larger than that of the 1st named treatment||
1644104|NCT01831817|3023032|Superiority or Other||Hodges-Lehmann shift|0.0||||0.2894|2-Sided|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment||
1644105|NCT01831817|3023032|Superiority or Other||Hodges-Lehmann shift|-5.0||||0.0002|2-Sided|95.0|-10.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment||
1644106|NCT01831817|3023032|Superiority or Other||Hodges-Lehmann shift|-5.0|||<|0.0001|2-Sided|95.0|-10.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment||
1644107|NCT01831817|3023032|Superiority or Other||Hodges-Lehmann shift|2.5|||<|0.0003|2-Sided|95.0|0.0|15.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment||
1644108|NCT01831817|3023032|Superiority or Other||Hodges-Lehmann shift|5.0|||<|0.0001|2-Sided|95.0|0.0|15.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment||
1644109|NCT01831817|3023032|Superiority or Other||Hodges-Lehmann shift|0.0|||<|0.9834|2-Sided|95.0|-5.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment||
1644110|NCT01831817|3023033|Superiority or Other||Hodges-Lehmann shift|0.0||||0.7138|2-Sided|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment||
1644111|NCT01831817|3023033|Superiority or Other||Hodges-Lehmann shift|0.0||||0.0122|2-Sided|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment||
1644112|NCT01831817|3023033|Superiority or Other||Hodges-Lehmann shift|0.0||||0.002|2-Sided|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the second named treatment||
1644113|NCT01831817|3023033|Superiority or Other||Hodges-Lehmann shift|0.0||||0.01|2-Sided|95.0|0.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment||
1644114|NCT01831817|3023033|Superiority or Other||Hodges-Lehmann shift|0.0||||0.0016|2-Sided|95.0|0.0|5.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment||
1644115|NCT01831817|3023033|Superiority or Other||Hodges-Lehmann shift|0.0||||0.9642|2-Sided|95.0|0.0|0.0|||Hodges-Lehmann Wilcoxon non-parametric||Positive values favour the first named treatment||
1644116|NCT01831817|3023034|Superiority or Other||Mean change difference|-0.04||||0.7872|2-Sided|95.0|-0.37|0.28|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons|
1644117|NCT01831817|3023034|Superiority or Other||Mean change difference|0.91|||<|0.0001|2-Sided|95.0|0.58|1.23|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons|
1644118|NCT01831817|3023034|Superiority or Other||Mean change difference|0.86|||<|0.0001|2-Sided|95.0|0.53|1.19|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons|
1644119|NCT01831817|3023034|Superiority or Other||Mean change difference|-0.86|||<|0.0001|2-Sided|95.0|-1.2|-0.53|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons|
1644120|NCT01831817|3023034|Superiority or Other||Mean change difference|-0.82|||<|0.0001|2-Sided|95.0|-1.16|-0.48|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons|
1644121|NCT01831817|3023034|Superiority or Other||Mean change difference|0.04|||<|0.803|2-Sided|95.0|-0.3|0.38|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons|
1644122|NCT01831817|3023035|Superiority or Other||Mean change difference|-0.01||||0.9606|2-Sided|95.0|-0.25|0.24|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons|
1644123|NCT01831817|3023035|Superiority or Other||Mean change difference|0.39||||0.0022|2-Sided|95.0|0.14|0.63|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is Second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline waas the same for both treatments in all pairwise comparisons|
1644147|NCT01830855|3023248|Superiority or Other||Ratio of GMTs|1.03|||||2-Sided|95.0|0.93|1.14||||||PMB80 [A22]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.|
1644337|NCT01822119|3023981|Superiority or Other|||||||0.28|||||||Fisher’s non-parametric permutation test|||80dB|
1644124|NCT01831817|3023035|Superiority or Other||Mean change difference|0.38||||0.0028|2-Sided|95.0|0.13|0.63|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is second named treatment - first named treatment that a negative difference implies the mean of the first named treatment is larger than that of the second named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons|
1644125|NCT01831817|3023035|Superiority or Other||Mean change difference|-0.49||||0.0002|2-Sided|95.0|-0.74|-0.24|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons|
1644126|NCT01831817|3023035|Superiority or Other||Mean change difference|-0.48||||0.0002|2-Sided|95.0|-0.73|-0.23|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference is First named treatment - second named treatment that a negative difference implies the mean of the second named treatment is larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons|
1644127|NCT01831817|3023035|Superiority or Other||Mean change difference|-0.1||||0.4321|2-Sided|95.0|-0.35|0.15|||ANCOVA||Treatment as fixed factor and baseline Schiff score as covariate. Difference was First named treatment-second named treatment that a negative difference implied the mean of the second named treatment was larger than that of the first named treatment|Principal null hypothesis to be tested was- H0: The change from baseline was the same for both treatments in all pairwise comparisons|
1644128|NCT01831765|3023090|Non-Inferiority or Equivalence|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomised treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|0.04|||||2-Sided|95.0|-0.04|0.12||||||Change from baseline in HbA1c analysed using a mixedeffect model for repeated measurements including visit 14, 18, 22, 26, 30, 34 and 36. The model included treatment, region and strata (combination of bolus adjusting method, basal treatment regimen and continuous glucose monitoring (CGM) and frequently sampled meal test subgroup) as fixed effects, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.|
1644129|NCT01831765|3023090|Non-Inferiority or Equivalence|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomised treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|-0.15|||||2-Sided|95.0|-0.23|-0.07||||||Change from baseline in HbA1c analysed using a mixed effect model for repeated measurements including visit 14, 18, 22, 26, 30, 34 and 36. The model included treatment, region and strata (combination of bolus adjusting method, basal treatment regimen and continuous glucose monitoring (CGM) and frequently sampled meal test subgroup) as fixed effects, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit.|
1644130|NCT01831466|3023125|Superiority or Other||Difference in response rates|6.7|Standard Error of the Mean|5.23||0.2021|2-Sided|80.0|0.0|13.4|||Cochran-Mantel-Haenszel||||
1644131|NCT01831466|3023125|Superiority or Other||Difference in response rates|11.0|Standard Error of the Mean|5.63||0.0513|2-Sided|80.0|3.8|18.2|||Cochran-Mantel-Haenszel||||
1644132|NCT01831466|3023125|Superiority or Other||Difference in response rates|-1.2|Standard Error of the Mean|5.2||0.8175|2-Sided|80.0|-7.9|5.5|||Cochran-Mantel-Haenszel||||
1644133|NCT01831466|3023125|Superiority or Other||Difference in response rates|10.8|Standard Error of the Mean|5.99||0.071|2-Sided|80.0|3.1|18.5|||Cochran-Mantel-Haenszel||||
1644134|NCT01831466|3023126|Superiority or Other||Difference in response rate|4.0|Standard Error of the Mean|6.34||0.5279|2-Sided|80.0|-4.1|12.1|||Cochran-Mantel-Haenszel||||
1644135|NCT01831466|3023126|Superiority or Other||Difference in response rates|3.3|Standard Error of the Mean|6.36||0.6039|2-Sided|80.0|-4.9|11.5|||Cochran-Mantel-Haenszel||||
1644136|NCT01831466|3023126|Superiority or Other||Difference in response rates|-4.0|Standard Error of the Mean|5.87||0.4976|2-Sided|80.0|-11.5|3.5|||Cochran-Mantel-Haenszel||||
1644137|NCT01831466|3023126|Superiority or Other||Difference in response rates|3.9|Standard Error of the Mean|6.36||0.5425|2-Sided|80.0|-4.3|12.0|||Cochran-Mantel-Haenszel||||
1644138|NCT01831154|3023152|Superiority or Other|||||||0.908||||||A one way ANOVA was used to determine if participants in the tight glycemic group had shorter intensive care unit (ICU) length of stay (LOS) than participants in the other interventional groups.|ANOVA||||
1644139|NCT01831154|3023153|Superiority or Other|||||||0.132|||||||ANOVA||||
1644140|NCT01831154|3023155|Superiority or Other|||||||0.024|||||||ANOVA||||
1644141|NCT01831154|3023156|Superiority or Other|||||||0.512|||||||Chi-squared|Chi-squared value of 1.34 and Cramer's V .190||Cross tabulation with statistical testing with chi-square and Cramer's V was performed on infection to determine if there was any difference in surgical site infections between the interventional groups in 30 day period.|
1644142|NCT01830855|3023248|Superiority or Other||Ratio of GMTs|1.0|||||2-Sided|95.0|0.88|1.14||||||PMB2948 [B24]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948|
1644143|NCT01830855|3023248|Superiority or Other||Ratio of GMTs|0.95|||||2-Sided|95.0|0.86|1.06||||||PMB2948 [B24]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.|
1644144|NCT01830855|3023248|Superiority or Other||Ratio of GMTs|0.95|||||2-Sided|95.0|0.85|1.06||||||PMB2948 [B24]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB2948.|
1644145|NCT01830855|3023248|Superiority or Other||Ratio of GMTs|0.99|||||2-Sided|95.0|0.88|1.12||||||PMB80 [A22]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.|
1644146|NCT01830855|3023248|Superiority or Other||Ratio of GMTs|1.02|||||2-Sided|95.0|0.92|1.13||||||PMB80 [A22]: The lot consistency criteria was achieved if the 95% CI for all pairwise GMRs between lots are within (0.5, 2), for the strain PMB80.|
1644338|NCT01822119|3023981|Superiority or Other|||||||0.72|||||||Fisher’s non-parametric permutation test|||60dB|
1644148|NCT01830699|3023260|Non-Inferiority or Equivalence|See details above regarding effect size, power, etc.||||||0.044|||||||t-test, 2 sided|||"Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0."|
1644149|NCT01830699|3023261|Non-Inferiority or Equivalence|For details of power calculation, see above. Using a minimal clinical importance of -9.1, the null hypothesis was a mean difference less than -9.1.|Mean Difference (Final Values)|-23.9||||0.004|||||||t-test, 2 sided|||"Setting α=0.05 and β=0.8, with effect size of 0.17 anticipated total n = 138 to be recruited (requested recruitment of 150 to account for possible drop-outs)~1st data analysis (n = 33), effect size calculated at 1.1 with new n = 29 with α=0.05 and β=1.0."|
1644150|NCT01830621|3023262|Superiority|||||||0.72|||||||Wilcoxon (Mann-Whitney)||||
1644151|NCT01830621|3023264|Superiority||Odds Ratio (OR)|0.98||||0.955|2-Sided|95.0|0.48|2.0|||Cochran-Mantel-Haenszel||||
1644152|NCT01830621|3023265|Superiority||Hazard Ratio (HR)|0.97||||0.837|2-Sided|95.0|0.76|1.26|||Log Rank||||
1644153|NCT01830621|3023266|Superiority||Hazard Ratio (HR)|1.13||||0.337|2-Sided|95.0|0.88|1.46|||Log Rank||||
1644154|NCT01830595|3023267|Superiority|||||||0.1|||||||t-test, 2 sided||||
1644155|NCT01830595|3023268|Superiority|||||||0.55|||||||t-test, 2 sided||||
1644156|NCT01830595|3023270|Superiority|||||||0.38|||||||t-test, 2 sided||||
1644157|NCT01830543|3023272|Superiority or Other||Hazard Ratio (HR)|1.44||||0.574|2-Sided|95.0|0.4|5.09|||Log Rank||||
1644158|NCT01830543|3023272|Superiority or Other||Hazard Ratio (HR)|1.2||||0.79|2-Sided|95.0|0.32|4.45|||Log Rank||||
1644159|NCT01830543|3023273|Superiority or Other||Hazard Ratio (HR)|1.36||||0.53|2-Sided|95.0|0.52|3.58|||Log Rank||||
1644160|NCT01830543|3023273|Superiority or Other||Hazard Ratio (HR)|1.07||||0.891|2-Sided|95.0|0.39|2.96|||Log Rank||||
1644161|NCT01830543|3023274|Superiority or Other||Hazard Ratio (HR)|0.75||||0.374|2-Sided|95.0|0.4|1.42|||Log Rank||||
1644162|NCT01830543|3023274|Superiority or Other||Hazard Ratio (HR)|0.86||||0.625|2-Sided|95.0|0.46|1.59|||Log Rank||||
1644163|NCT01830543|3023275|Superiority or Other||Hazard Ratio (HR)|1.19||||0.664|2-Sided|95.0|0.54|2.62|||Log Rank||||
1644164|NCT01830543|3023275|Superiority or Other||Hazard Ratio (HR)|1.29||||0.523|2-Sided|95.0|0.59|2.8|||Log Rank||||
1644165|NCT01830543|3023276|Superiority or Other||Hazard Ratio (HR)|0.93||||0.765|2-Sided|95.0|0.59|1.48|||Log Rank||||
1644166|NCT01830543|3023276|Superiority or Other||Hazard Ratio (HR)|1.08||||0.75|2-Sided|95.0|0.69|1.68|||Log Rank||||
1644167|NCT01830543|3023277|Superiority or Other||Hazard Ratio (HR)|0.67||||0.002|2-Sided|95.0|0.52|0.86|||Log Rank||||
1644168|NCT01830543|3023277|Superiority or Other||Hazard Ratio (HR)|0.61|||<|0.001|2-Sided|95.0|0.47|0.8|||Log Rank||||
1644169|NCT01830543|3023278|Superiority or Other||Hazard Ratio (HR)|0.5||||0.134|2-Sided|95.0|0.2|1.26|||Log Rank||||
1644170|NCT01830543|3023278|Superiority or Other||Hazard Ratio (HR)|0.51||||0.144|2-Sided|95.0|0.2|1.28|||Log Rank||||
1644171|NCT01830543|3023279|Superiority or Other||Hazard Ratio (HR)|0.57||||0.114|2-Sided|95.0|0.28|1.16|||Log Rank||||
1644172|NCT01830543|3023279|Superiority or Other||Hazard Ratio (HR)|0.66||||0.234|2-Sided|95.0|0.33|1.31|||Log Rank||||
1644173|NCT01830543|3023280|Superiority or Other||Hazard Ratio (HR)|0.63|||<|0.001|2-Sided|95.0|0.5|0.8|||Log Rank||||
1644174|NCT01830543|3023280|Superiority or Other||Hazard Ratio (HR)|0.59|||<|0.001|2-Sided|95.0|0.47|0.76|||Log Rank||||
1644175|NCT01829425|3023377|Non-Inferiority|The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%. If|Difference in median % change between gr|5.0|||<|0.025|1-Sided|95.0|5.0||||Exact Mann Whitney||||
1644176|NCT01829425|3023378|Non-Inferiority|The study design will use a non-inferiority design to compare the primary outcome (change in UUI episodes in the hypnotherapy versus pharmacotherapy groups). With respect to the outcome variable of percent reduction in UUI episodes as determined by bladder diaries, we will use a one-sided non- inferiority test at level alpha = 0.25 and a non-inferiority margin of 5%.|Difference in median % change between gr|5.0|||<|0.025|1-Sided|95.0|5.0||||Exact Mann Whitney|Due dispersion, medians were calculated. Exact Mann Whitney test was used for this analysis.|Hypnotherapy - Pharmacotherapy. % difference in median % change in UUI episodes with lower bounds > - 5% would be consistent with non-inferiority||
1644177|NCT01829360|3023382|Superiority||||||<|0.05|||||||Mixed Models Analysis|||The interim definition data were analyzed with the primary pre-/post-definition data to capture growth across the entire treatment period.|
1644178|NCT01829360|3023383|Other|A secondary analysis was performed to examine individual differences in treatment outcomes. This was done collapsed across all arms because the difference between the arms/treatments was not significant in the primary analysis. This was done by adding predictors to the primary analysis model to determine if learner characteristics were significantly related to growth in word defining. All continuous learner characteristics were grand mean centered.|||||<|0.05|||||||Mixed Models Analysis||||
1644179|NCT01829360|3023383|Superiority||||||<|0.05|||||||Mixed Models Analysis|The significance of fixed effects (e.g.,treatment) was evaluated using Wald tests|||
1644180|NCT01829347|3023384|Superiority|||||||1|||||||Fisher Exact||||
1644181|NCT01829347|3023385|Superiority||Hazard Ratio (HR)|0.31||||0.076|2-Sided|95.0|0.085|1.133|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-Treat (ITT) population utilizing a log-rank test.|
1644200|NCT01827670|3023520|Superiority or Other||Adjusted Mean|7.5||||0.0138|2-Sided|95.0|1.6|13.4|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline tactile threshold as covariate|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a positive difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"|
1644182|NCT01828567|3023445|Equivalence|This model assumes the groups have equal baseline means|Mean Difference (Final Values)|0.7||||0.33|2-Sided|95.0|-0.7|2.2|||Repeated Measures|A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in FRS scores between the usual care and intervention arms at 6 month.|Our secondary outcome of interest is the Framingham Risk Score, measured at baseline and month 6.|
1644183|NCT01828567|3023447|Equivalence|This model assumes the groups have equal baseline means, which is appropriate for a randomized controlled trial and is equivalent in efficiency to an ANCOVA model.|Mean Difference (Final Values)|2.5||||0.03|2-Sided|95.0|0.2|4.7||A general Linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time. For the primary hypothesis we will be assessing sustainability at 6 months.|Repeated Measures|This model assumes the groups have equal baseline means.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 6 month.||
1644184|NCT01828567|3023448|Other||Mean Difference (Final Values)|1.5||||0.204|2-Sided|95.0|-0.8|3.7||A general linear model with an unstructured covariance matrix to take into account the within-patient correlation between repeated measures over time.|Repeated Measures|This model assumes the groups have equal baseline means.|We estimate the parameters in the model using the SAS procedure MIXED (SAS Version 9.4, Cary, NC). The null hypothesis is that there is no difference in improvement in PAM scores between the usual care and intervention arms at 1 month.|For the primary hypothesis we will be examining the effect during the 1-month long intervention delivery period.|
1644185|NCT01828567|3023450|Other|A logistic regression model was used. The null hypothesis is that there is no difference in improvement prevention program enrollment between the usual care and intervention arms by month 6.|Odds Ratio (OR)|2.54|||<|0.0001|2-Sided|95.0|1.66|3.89|||Regression, Logistic|||The first primary outcome is the cumulative enrollment in prevention programs over the six months of follow up. This will be assessed via self-report at months 1 and 6. As defined by the eligibility criteria, all patients will have a value of 0 at baseline.|
1644186|NCT01828554|3023453|Other|||||||0.7497||||||A paired t-test will be used to compare the PK parameters between the full weight and limited weight based dosing.|t-test, 2 sided||||
1644187|NCT01828554|3023454|Other|||||||0.4882||||||A paired t-test will be used to compare the PK parameters between the full weight and limited weight based dosing.|t-test, 2 sided|||The null hypothesis that the AUC from cycle 1 day 1 (based on ideal body weight) is equal to the AUC from cycle 1 day 9 (based on actual body weight) was tested against the alternative hypothesis that the AUCs are not equal. A linear mixed effect model with patient specific random effects was conducted|
1644188|NCT01828164|3023469|Non-Inferiority|1 point on the 10-point pain scale was used as the non-inferiority margin.|||||<|0.001|||||||Bootstrapped mean difference|This test bootstrapped the mean difference (Treatment Arm – Control Arm) less 1, the non-inferiority margin, 1000 times.|||
1644189|NCT01828164|3023470|Superiority or Other||Percent change|220.8||||0.0423|2-Sided||||||t-test, 1 sided||Percent change in root resorption rate on the control side as compared to the treatment side.||
1644190|NCT01828164|3023471|Superiority or Other||Percent Change|29.0||||0.0164|2-Sided||||||t-test, 1 sided||Percent change in tooth movement rate on the treatment side as compared to the control side.||
1644191|NCT01828112|3023482|Superiority or Other (legacy)||Hazard Ratio (HR)|0.49|||<|0.001|2-Sided|95.0|0.36|0.67|||Log Rank||||
1644192|NCT01828099|3023489|Superiority or Other (legacy)||Hazard Ratio (HR)|0.55|||<|0.001|2-Sided|95.0|0.42|0.73|||Stratisfied Log Rank||||
1644193|NCT01828073|3023490|Other|||||||0.341||||||The study was not powered to do the comparison. This was an exploratory analysis.|Wilcoxon (Mann-Whitney)|||To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in LBW infants.|
1644194|NCT01828073|3023490|Other|||||||0.747||||||The study was not powered to do the comparison. This was an exploratory analysis.|Wilcoxon (Mann-Whitney)|||To investigate the relationship between neonatal RAL elimination and UGT1A1 genotype in full term infants.|
1644195|NCT01828073|3023494|Other||Clopper-Pearson Confidence Interval (CI)|50.0|||||2-Sided|90.0|29.1|70.9|||||With the small sample size, the CI estimate tend to be wide.|Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, death)|
1644196|NCT01828073|3023494|Other||Clopper-Pearson Confidence Interval (CI)|31.82|||||2-Sided|90.0|16.0|51.5|||||With the small sample size, the CI estimate tend to be wide.|Point and 90% CI estimates of percentage of full term infants meeting the composite safety endpoint (grade 3/4 adverse event, adverse birth outcome, death)|
1644197|NCT01827787|3023517|Superiority|||||||0.42|||||||Fisher Exact|||"Using a one sample binomial design, with 45 patients there was 90% power to detect a null hypothesis 30% overall response rate (historical control) versus an alternative hypothesis of 53% overall response rate assuming a two-sided 10% alpha.~Of note, cohort 2: TNBC did not fully accrue 45 patients so a testing was not done."|
1644198|NCT01827670|3023518|Superiority or Other||Adjusted Mean|-21.82|||<|0.0001|2-Sided|95.0|-29.55|-14.09|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline VAS as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments."|
1644199|NCT01827670|3023519|Superiority or Other||Adjusted Mean|-12.14||||0.0003|2-Sided|95.0|-18.51|-5.77|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline VAS as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"|
1644240|NCT01827046|3023594|Superiority||Cox Proportional Hazard|0.67||||0.037|2-Sided|95.0|0.45|0.98|||Adjusted Cox proportional Hazard|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location, diabetes, cardiovascular disease and race.|||
1644241|NCT01827046|3023594|Superiority|||||||0.08|||||||Log Rank||||
1644201|NCT01827670|3023521|Superiority or Other||Adjusted Mean Difference|27.2|||<|0.0001|2-Sided|95.0|19.4|35.1|||ANCOVA|From ANCOVA model: Treatment and baseline Schiff stratification value as fixed factor and baseline tactile threshold as covariate|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a positive difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"|
1644202|NCT01827670|3023522|Superiority or Other||Adjusted Mean|-0.81|||<|0.0001|2-Sided|95.0|-1.0|-0.62|||ANCOVA|From ANCOVA model: Treatment as fixed factor & baseline Schiff score as covariate.|Difference was 0.454% Stannous Fluoride minus 0.76% Sodium MonoFluorophosphate such that a negative difference favored first named treatment|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"|
1644203|NCT01827670|3023523|Superiority or Other||Adjusted Mean|-1.29|||<|0.0001|2-Sided|95.0|-1.53|-1.06|||ANCOVA|From ANCOVA model: Treatment as fixed factor & baseline Schiff score as covariate.|Difference was 0.454% stannous fluoride minus 0.76% sodium monofluorophosphate such that a negative difference favours first named treatment.|"The principal null hypothesis tested was as follows:~H0: The change from baseline was same for both treatments. H1: The change from baseline was different for both the treatments"|
1644204|NCT01827371|3023539|Non-Inferiority or Equivalence|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|-0.1|||||2-Sided|98.33|-0.5|0.3||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm D)) ≥ 1 or GMT(Arm A)/GMT (Arm D) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm D)) < 1 or GMT(Arm A)/GMT(Arm D) < 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."|
1644205|NCT01827371|3023539|Non-Inferiority or Equivalence|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.3|||||2-Sided|98.33|-0.06|0.67||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm C)) ≥ 1 or GMT(Arm A)/GMT (Arm C) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm C)) < 1 or GMT(Arm A)/GMT(Arm C) < 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."|
1644206|NCT01827371|3023539|Non-Inferiority or Equivalence|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.76|||||2-Sided|98.33|0.37|1.15||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm B)) ≥ 1 or GMT(Arm A)/GMT (Arm B) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm B)) < 1 or GMT(Arm A)/GMT(Arm B) < 2.~The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used."|
1644207|NCT01827371|3023540|Superiority or Other|||||||0.0012||||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr(‘Any Solicited Local Reaction‘ Arm A) = Pr(‘Any Solicited Local Reaction‘ Arm D) H1: Pr(‘Any Solicited Local Reaction‘ Arm A) not = Pr(‘Any Solicited Local Reaction‘ Arm D)"|
1644208|NCT01827371|3023540|Superiority or Other|||||||0.005||||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr(‘Swelling at Injection Site‘ Arm A) = Pr(‘Swelling at Injection Site‘ Arm D) H1: Pr(‘Swelling at Injection Site‘ Arm A) not = Pr(‘Swelling at Injection Site‘ Arm D)"|
1644209|NCT01827371|3023540|Superiority or Other||||||<|0.0001||||||alpha=5%|Fisher Exact|||"Hypothesis:~H0: Pr(‘Redness at Injection Site‘ Arm A) = Pr(‘Redness at Injection Site‘ Arm D) H1: Pr(‘Redness at Injection Site‘ Arm A) not = Pr(‘Redness at Injection Site‘ Arm D)"|
1644210|NCT01827371|3023540|Superiority or Other||||||<|0.6171||||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Underarm swelling' Arm A) = Pr('Underarm swelling' Arm D) H1: Pr('Underarm swelling' Arm A) not = Pr('Underarm swelling' Arm D)"|
1644211|NCT01827371|3023540|Superiority or Other||||||<|1||||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Underarm pain' Arm A) = Pr('Underarm pain' Arm D) H1: Pr('Underarm pain' Arm A) not = Pr('Underarm pain' Arm D)"|
1644212|NCT01827371|3023540|Superiority or Other||||||<|0.1704||||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr('Itchiness at Injection Site' Arm A) = Pr('Itchiness at Injection Site' Arm D) H1: Pr('Itchiness at Injection Site' Arm A) not = Pr('Itchiness at Injection Site' Arm D)"|
1644213|NCT01827371|3023540|Superiority or Other||||||<|0.4782||||||alpha= 5%|Fisher Exact|||"Hypothesis:~H0: Pr(‘Pain at Injection Site ‘ Arm A) = Pr(‘Pain at Injection Site ‘ Arm D) H1: Pr(‘Pain at Injection Site ‘ Arm A) not = Pr(‘Pain at Injection Site ‘ Arm D)"|
1644214|NCT01827371|3023541|Non-Inferiority or Equivalence|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.41|||||2-Sided|98.33|-0.17|1.0007||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm D)) ≥ 1 or GMT(Arm A)/GMT (Arm D) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm D)) < 1 or GMT(Arm A)/GMT(Arm D) < 2.~Sample Size: The SD for log2 PRNT based on a prior study was~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"|
1644333|NCT01822119|3023978|Superiority or Other|||||||0.71|||||||Fisher’s non-parametric permutation test|||Ease of Communication|
1644215|NCT01827371|3023541|Non-Inferiority or Equivalence|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|0.86|||||2-Sided|98.33|0.26|1.47||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm C)) ≥ 1 or GMT(Arm A)/GMT (Arm C) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm C)) < 1 or GMT(Arm A)/GMT(Arm C) < 2.~Sample Size: The SD for log2 PRNT based on a prior study was~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"|
1644216|NCT01827371|3023541|Non-Inferiority or Equivalence|Hypotheses Evaluation: The difference between the mean log2 peak titer for the control arm (Study Arm A) and each investigational arm (Study Arm B, C, or D) and the associated two sided 98.33% confidence intervals (CI) for the estimated population mean difference were calculated. If the upper limit of the 98.33% CI was less than 1, Study Arm B, C or D was considered to be non-inferior to Study Arm A.|Mean Difference (Log2 Scale)|1.32|||||2-Sided|98.33|0.72|1.93||||||"Hypotheses: H0: log2(GMT(Arm A))-log2 (GMT(Arm B)) ≥ 1 or GMT(Arm A)/GMT (Arm B) ≥2 H1: log2(GMT(Arm A))-log2(GMT(Arm B)) < 1 or GMT(Arm A)/GMT(Arm B) < 2.~Sample Size: The SD for log2 PRNT based on a prior study was~1.9. The margin of non-inferiority was specified as a 2-fold difference on the original scale (1 on the log2 scale). The objective included three non-inferiority evaluations (A vs. B, A vs. C, A vs. D). Thus, a Bonferroni-corrected alpha of 2.5% / 3 = 0.833% was used. Power=80%"|
1644217|NCT01827358|3023546|Other||Hazard Ratio (HR)|0.24||||0.198|2-Sided|95.0|0.03|2.12|||Cox proportional hazards model|||The time to clinical infection with SA on or prior to Day 22 was analyzed using Kaplan-Meier estimates of the survival curve and Cox proportional hazards models (with treatment as the only independent variable). Infants were censored at Day 22 or completion or early termination from the study. Estimates of the hazard ratio (values less than one indicating a treatment benefit) with Wald 95% confidence intervals and accompanying p-values were calculated.|
1644218|NCT01827358|3023547|Other||Hazard Ratio (HR)|0.23||||0.182|2-Sided|95.0|0.03|2.01|||Cox proportional hazards models|||The time to clinical infection with SA on or prior to Day 22 was analyzed using Kaplan-Meier estimates of the survival curve and Cox proportional hazards models (with treatment as the only independent variable). Infants were censored at Day 22 or completion or early termination from the study. Estimates of the hazard ratio (values less than one indicating a treatment benefit) with Wald 95% confidence intervals and accompanying p-values were calculated.|
1644219|NCT01827358|3023549|Other||Hazard Ratio (HR)|1.33||||0.656|2-Sided|95.0|0.37|4.76|||Cox proportional hazards model|||The association between mupirocin treatment and non-clinical SA Infection on or before Day 85 was assessed via a Cox Proportional Hazards Model. Onset time was defined as the first day of non-SA infection. Infants were right-censored at the time of discharge from the hospital or at Day 85, whichever came first.|
1644220|NCT01827358|3023550|Other||Hazard Ratio (HR)|1.0||||0.997|2-Sided|95.0|0.3|3.28|||Cox proportional hazards model|||The association between mupirocin treatment and non-clinical SA Infection on or before Day 85 was assessed via a Cox Proportional Hazards Model. Onset time was defined as the first day of non-SA infection. Infants were right-censored at the time of discharge from the hospital or at Day 85, whichever came first.|
1644221|NCT01827358|3023551|Other|For strong control of the family-wise error rate at the 0.05 confidence level, the Holm procedure (Holm 1979) is used. Under this procedure, the p-values from the two tests are sorted as p_((1)) (smaller p-value) and p_((2)) (larger p-value). If p_((1))=0.025 and p_((2))=0.05, then the null hypotheses for both tests are rejected. If p_((1))=0.025 and p_((2))>0.05, then only the null hypothesis associated with the smaller p-value is rejected. In any other case, neither null hypothesis is rejected|Odds Ratio (OR)|39.5|||<|0.001|2-Sided|95.0|5.5|1666.3|||Fisher Exact||||
1644222|NCT01827358|3023552|Other|For strong control of the family-wise error rate at the 0.05 confidence level, the Holm procedure (Holm 1979) is used. Under this procedure, the p-values from the two tests are sorted as p_((1)) (smaller p-value) and p_((2)) (larger p-value). If p_((1))=0.025 and p_((2))=0.05, then the null hypotheses for both tests are rejected. If p_((1))=0.025 and p_((2))>0.05, then only the null hypothesis associated with the smaller p-value is rejected. In any other case, neither null hypothesis is rejected|Odds Ratio (OR)|315.2|||<|0.001|2-Sided|97.5|49.6|2698.8|||Fisher Exact||||
1644223|NCT01827046|3023580|Superiority|||||||0.01|||||||Chi-squared||||
1644224|NCT01827046|3023581|Superiority|||||||0.16|||||||Chi-squared||||
1644225|NCT01827046|3023582|Superiority|||||||0.32|||||||Chi-squared||||
1644226|NCT01827046|3023583|Superiority|||||||0.05|||||||Chi-squared||||
1644227|NCT01827046|3023584|Superiority|||||||0.02|||||||Chi-squared||||
1644228|NCT01827046|3023585|Superiority|||||||0.87|||||||Chi-squared||||
1644229|NCT01827046|3023586|Superiority|||||||0.66|||||||Wilcoxon (Mann-Whitney)||||
1644230|NCT01827046|3023587|Superiority|||||||0.75|||||||Median test||||
1644231|NCT01827046|3023588|Superiority|||||||0.46|||||||Median test||||
1644232|NCT01827046|3023589|Superiority||Odds Ratio (OR)|1.24||||0.35|2-Sided|95.0|0.79|1.97|||Multivariate logit model|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location|||
1644233|NCT01827046|3023589|Superiority||Risk Difference (RD)|0.01||||0.79|2-Sided|95.0|-0.07|0.09|||Chi-squared||||
1644234|NCT01827046|3023590|Superiority||Odds Ratio (OR)|1.25||||0.31|2-Sided|95.0|0.81|1.94|||Multivariate logit model|Adjusted for age, GCS, Stability ICH volume, Stability IVH volume, ICH deep location|||
1644235|NCT01827046|3023590|Superiority||Risk Difference (RD)|-0.01||||0.76|2-Sided|95.0|-0.1|0.07|||Chi-squared||||
1644236|NCT01827046|3023591|Superiority||Risk Difference (RD)|0.04||||0.34|2-Sided|95.0|-0.04|0.11|||Chi-squared||||
1644237|NCT01827046|3023592|Superiority|||||||0.78|||||||Wilcoxon (Mann-Whitney)||||
1644238|NCT01827046|3023593|Superiority||Odds Ratio (OR)|0.68|||<|0.001|2-Sided|95.0|0.59|0.78|||Multivariate logit model|Adjusted for age, GCS, stability IVH volume, and ICH deep location|||
1644239|NCT01827046|3023593|Superiority||Odds Ratio (OR)|0.7|||<|0.001|2-Sided|95.0|0.62|0.8|||Logit model||||
1644242|NCT01827046|3023595|Superiority||Risk Difference (RD)|1.26||||0.27|2-Sided|95.0|0.82|1.97|||Multivariate logit model|Adjusted for age, GCS, stability ICH volume, stability IVH volume and ICH deep location|||
1644243|NCT01827046|3023595|Superiority||Risk Difference (RD)|0.03||||0.55|2-Sided|95.0|-0.06|0.11|||Chi-squared||||
1644244|NCT01827046|3023596|Superiority||Risk Difference (RD)|4.0||||0.33|2-Sided|95.0|-4.0|12.0|||Multivariate logit model|||Adjusted for age, GCS, stability ICH volume, stability IVH volume, ICH deep location|
1644245|NCT01827046|3023596|Superiority||Risk Difference (RD)|2.0||||0.73|2-Sided|95.0|-6.8|10.7|||Chi-squared||||
1644246|NCT01826422|3023635|Superiority|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)||||
1644247|NCT01826422|3023636|Superiority|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)||||
1644248|NCT01826422|3023637|Superiority|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis||||
1644249|NCT01826422|3023638|Superiority||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis||||
1644250|NCT01826422|3023639|Superiority or Other||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis||||
1644251|NCT01826422|3023640|Superiority||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis||||
1644252|NCT01826422|3023641|Superiority||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis||||
1644253|NCT01826422|3023642|Superiority||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis||||
1644254|NCT01826422|3023643|Superiority|||||||0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided||||
1644255|NCT01826422|3023644|Superiority||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided||||
1644256|NCT01826422|3023645|Superiority||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|t-test, 1 sided||||
1644257|NCT01826422|3023646|Superiority||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis||||
1644258|NCT01826422|3023647|Superiority or Other||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis||||
1644259|NCT01826422|3023648|Superiority||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis||||
1644260|NCT01826422|3023649|Superiority or Other||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Kruskal-Wallis||||
1644261|NCT01826422|3023650|Superiority||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)||||
1644262|NCT01826422|3023651|Superiority or Other||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)||||
1644263|NCT01826422|3023652|Superiority or Other||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)||||
1644264|NCT01826422|3023653|Superiority or Other||||||>|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)||||
1644265|NCT01826422|3023654|Superiority||||||<|0.05||||||Between-groups analysis (omega 3 vs placebo) at 3 and 6 months.|Wilcoxon (Mann-Whitney)||||
1644266|NCT01825577|3023716|Superiority or Other||Mean Difference (Final Values)|1.1||||0.67|2-Sided||||||t-test, 2 sided||||
1644267|NCT01825577|3023717|Superiority or Other||Mean Difference (Final Values)|9.9||||0.55|2-Sided||||||t-test, 2 sided||||
1644268|NCT01824290|3023795|Superiority||Mean Difference (Final Values)|23.88|Standard Error of the Mean|29.114|||2-Sided|80.0|-14.25|62.0|||||||
1644269|NCT01823341|3023835|Superiority or Other|||||||0.28|||||||t-test, 2 sided||||
1644270|NCT01823341|3023835|Superiority or Other|||||||0.53|||||||t-test, 2 sided||||
1644271|NCT01823341|3023836|Superiority or Other|||||||0.39|||||||t-test, 2 sided||||
1644272|NCT01823341|3023836|Superiority or Other|||||||0.16|||||||t-test, 2 sided||||
1644273|NCT01823341|3023837|Superiority or Other|||||||0.18|||||||t-test, 2 sided||||
1644274|NCT01823341|3023837|Superiority or Other|||||||0.57|||||||t-test, 2 sided||||
1644275|NCT01823341|3023838|Superiority or Other|||||||0.11|||||||t-test, 2 sided||||
1644276|NCT01823341|3023838|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1644277|NCT01823341|3023839|Superiority or Other|||||||0.77|||||||t-test, 2 sided||||
1644278|NCT01823341|3023839|Superiority or Other|||||||0.18|||||||t-test, 2 sided||||
1644279|NCT01823341|3023840|Superiority or Other|||||||0.5|||||||t-test, 2 sided||||
1644280|NCT01823341|3023840|Superiority or Other|||||||0.1|||||||t-test, 2 sided||||
1644281|NCT01823341|3023841|Superiority or Other|||||||0.004|||||||t-test, 2 sided||||
1644282|NCT01823341|3023841|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1644283|NCT01823341|3023842|Superiority or Other|||||||0.005|||||||t-test, 2 sided||||
1644284|NCT01823341|3023842|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1644285|NCT01823341|3023843|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1644286|NCT01823341|3023843|Superiority or Other|||||||0.01|||||||t-test, 2 sided||||
1644287|NCT01823341|3023844|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1644288|NCT01823224|3023856|Superiority or Other||||||>|0.05|||||||Manova||||
1644289|NCT01823224|3023857|Superiority or Other|||||||0.875|||||||Repeated analysis of variance||||
1644290|NCT01822899|3023876|Superiority or Other||Mean Difference (Net)|0.08|||<|0.001|2-Sided|95.0|0.046|0.113|||ANCOVA||||
1644291|NCT01822821|3023882|Superiority or Other||ratio of geometric means|1.1||||0.4|2-Sided|99.4|0.87|1.3|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on bilirubin was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.||
1644334|NCT01822119|3023978|Superiority or Other|||||||0.59|||||||Fisher’s non-parametric permutation test|||Aversiveness|
1644292|NCT01822821|3023883|Superiority or Other||ratio of geometric means|1.0||||0.98|2-Sided|99.4|0.8|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on AST was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.||
1644293|NCT01822821|3023884|Superiority or Other||ratio of geometric means|1.1||||0.31|2-Sided|99.4|0.9|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on ALT was assessed by use of the ratio of geometric means from a repeated measures multivariable logistic regression models adjusting for age and diabetes.||
1644294|NCT01822821|3023885|Superiority or Other||ratio of geometric means|1.1||||0.12|2-Sided|99.4|0.94|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.||
1644295|NCT01822821|3023886|Superiority or Other||ratio of geometric means|0.93||||0.38|2-Sided|99.4|0.74|1.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of ICU stay was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.||
1644296|NCT01822821|3023887|Superiority or Other||ratio of geometric means|1.3||||0.46|2-Sided|99.4|0.52|3.2|||Regression, Linear||Outcome log-transformed to meet model assumptions. The treatment effect on duration of mechanical ventilation was assessed by use of the ratio of geometric means from a multivariable logistic regression models adjusting for age and diabetes.||
1644297|NCT01822821|3023888|Superiority or Other||Mean Difference (Final Values)|0.0||||0.38|2-Sided|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 24 hours after surgery|
1644298|NCT01822821|3023888|Superiority or Other||Median Difference (Final Values)|0.0||||0.44|2-Sided|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 16 hours after surgery.|
1644299|NCT01822821|3023888|Superiority or Other||Median Difference (Final Values)|0.0||||0.13|2-Sided|99.8|0.0|0.0|||Wilcoxon (Mann-Whitney)||Difference in medians of IV acetaminophen versus placebo patients based on Wilcoxon rank sum test and Hodges-Lehmann estimation of location shift.|Analysis at 8 hours after surgery.|
1644300|NCT01822821|3023889|Superiority or Other||Risk Ratio (RR)|0.76||||0.35|2-Sided|99.4|0.34|1.7|||Regression, Logistic||Relative risk of PONV in IV acetaminophen versus placebo patients estimated from a multivariable logistic regression model using the log link and adjusting for age and diabetes.||
1644301|NCT01822821|3023890|Superiority or Other||Mean Difference (Final Values)|-0.9|||<|0.001|1-Sided|95.0||-0.42|||Regression, Linear||Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.||
1644302|NCT01822821|3023890|Non-Inferiority or Equivalence|We assessed whether IV acetaminophen is noninferior to placebo using a noninferiority margin of 1.0.|Median Difference (Final Values)|-0.9|||<|0.001|1-Sided|90.0||-0.5|||Regression, Linear||Difference in overall postoperative pain score means based on a repeated measures linear regression model with an autoregressive correlation structure, adjusting for age, time, and diabetes.||
1644303|NCT01822821|3023891|Superiority or Other||ratio of geometric means|0.89||||0.28|1-Sided|95.0||1.1|||Regression, Linear||Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.||
1644304|NCT01822821|3023891|Non-Inferiority or Equivalence|Noninferiority was tested using a noninferiority margin of 1.15.|ratio of geometric means|0.89||||0.08|1-Sided|90.0||1.06|||Regression, Linear||Ratio of geometric means (CI) for IV acetaminophen versus placebo was estimated as the exponentiated treatment effect parameter from a multivariable linear regression model on log opioid consumption adjusting for age and diabetes.||
1644305|NCT01822665|3023906|Superiority or Other||Odds Ratio (OR)|1.94||||0.2845|2-Sided|95.0|0.58|6.5|||Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.||
1644306|NCT01822665|3023906|Superiority or Other||Odds Ratio (OR)|3.19||||0.0999|2-Sided|95.0|0.8|12.74||P-value associated with chi-square testing odds ratio.|Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.||
1644307|NCT01822665|3023906|Superiority or Other||Odds Ratio (OR)|6.19||||0.0084|2-Sided|95.0|1.6|23.97||P-value associated with chi-square testing odds ratio.|Chi-squared||Odds Ratio from logistic regression model with treatment as factor and period as covariate.||
1644308|NCT01822665|3023907|Superiority or Other||LS mean difference|0.23||||0.2855|2-Sided|95.0|-0.2|0.65||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.|
1644309|NCT01822665|3023907|Superiority or Other||LS mean difference|0.26||||0.2227|2-Sided|95.0|-0.16|0.67||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments|
1644310|NCT01822665|3023907|Superiority or Other||LS mean difference|0.03||||0.8903|2-Sided|95.0|-0.39|0.45||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments|
1644335|NCT01822119|3023979|Superiority or Other|||||||0.0092|||||||Fisher’s non-parametric permutation test||||
1644336|NCT01822119|3023980|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test||||
1644311|NCT01822665|3023907|Superiority or Other||LS mean difference|0.17||||0.4126|2-Sided|95.0|-0.24|0.57||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.|
1644312|NCT01822665|3023907|Superiority or Other||LS mean difference|-0.06||||0.7591|2-Sided|95.0|-0.46|0.34||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments|
1644313|NCT01822665|3023907|Superiority or Other||LS mean difference|-0.09||||0.6497|2-Sided|95.0|-0.49|0.31||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments.|
1644314|NCT01822665|3023908|Superiority or Other||LS mean difference|0.89||||0.002|2-Sided|95.0|0.34|1.45||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.|
1644315|NCT01822665|3023908|Superiority or Other||LS mean difference|1.3|||<|0.0001|2-Sided|95.0|0.75|1.84||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.|
1644316|NCT01822665|3023908|Superiority or Other||LS mean difference|0.4|||<|0.1429|2-Sided|95.0|-0.14|0.95||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.|
1644317|NCT01822665|3023908|Superiority or Other||LS mean difference|0.19|||<|0.4794|2-Sided|95.0|-0.34|0.72||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.|
1644318|NCT01822665|3023908|Superiority or Other||LS Mean Difference|-0.7|||<|0.0095|2-Sided|95.0|-1.23|-0.18|||t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.|
1644319|NCT01822665|3023909|Superiority or Other||Least squares mean difference|-1.11|||<|0.0001|2-Sided|95.0|-1.63|-0.59||No multiple comparisons were carried out.|t-test, 2 sided|Period and treatment were included in the model as fixed effects, while subjects were a random effect.|Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment.|Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments.|
1644320|NCT01822574|3023915|Superiority or Other|||||||0.24|||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.|
1644321|NCT01822574|3023916|Superiority or Other||||||<|0.001|||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.|
1644322|NCT01822574|3023917|Superiority or Other|||||||0.001|||||||ANOVA|||A p-value less than 0.05 was considered statistically significant.|
1644323|NCT01822548|3023923|Superiority||Slope|-0.067|||<|0.05|2-Sided|95.0|-0.358|0.224|||ANOVA||||
1644324|NCT01822548|3023924|Superiority||Slope|0.362|||<|0.05|2-Sided|95.0|0.028|0.695|||ANOVA|adjustment for baseline value of EPC|||
1644325|NCT01822548|3023924|Other||||||<|0.05|||||||Regression, Linear|Generalized linear model (GLM)|||
1644326|NCT01822535|3023925|Superiority or Other|||||||0.3|||||||ANOVA|||"We hypothesized that administration of midodrine would attenuate the fall in core body temperature.~Within-group percent changes in core body temperature were analyzed to compare data from visit 1 (no drug) to visit 2 (drug)."|
1644327|NCT01822535|3023926|Superiority or Other|||||||0.0431|||||||ANOVA|||"Between-group comparisons of percent changes in Delayed Recall from baseline values to after cool exposure were analyzed.~We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls."|
1644328|NCT01822535|3023927|Superiority or Other|||||||0.018|||||||ANOVA|||"Between-group comparisons of percent changes in Stroop Interference T-scores from baseline values to after cool exposure were analyzed.~We hypothesized that subjects with tetraplegia would have greater declines in cognitive performance after cool exposure than able-bodied controls."|
1644329|NCT01822535|3023928|Superiority or Other||||||<|0.01|||||||ANOVA|||Between-group differences in percent changes in core body temperature from baseline values to after cool exposure were analyzed. Because individuals with tetraplegia have impaired thermoregulatory mechanisms, we hypothesized that their percent change in core body temperature would be significantly larger than that of able-bodied controls.|
1644330|NCT01822119|3023978|Superiority or Other|||||||0.5|||||||Fisher’s non-parametric permutation test|||Global score|
1644331|NCT01822119|3023978|Superiority or Other|||||||0.4|||||||Fisher’s non-parametric permutation test|||Background noise|
1644332|NCT01822119|3023978|Superiority or Other|||||||0.59|||||||Fisher’s non-parametric permutation test|||Reverberation|
1644339|NCT01822119|3023981|Superiority or Other|||||||0.55|||||||Fisher’s non-parametric permutation test|||50dB|
1644340|NCT01822119|3023982|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||Statistically significant improvement with the same value at all presentation levels.|
1644341|NCT01822119|3023983|Superiority or Other|||||||0.13|||||||Fisher’s non-parametric permutation test|||8000Hz|
1644342|NCT01822119|3023983|Superiority or Other|||||||0.0085|||||||Fisher’s non-parametric permutation test|||6000Hz|
1644343|NCT01822119|3023983|Superiority or Other|||||||0.026|||||||Fisher’s non-parametric permutation test|||4000Hz|
1644344|NCT01822119|3023983|Superiority or Other|||||||0.83|||||||Fisher’s non-parametric permutation test|||3000Hz|
1644345|NCT01822119|3023983|Superiority or Other|||||||0.24|||||||Fisher’s non-parametric permutation test|||2000Hz|
1644346|NCT01822119|3023983|Superiority or Other|||||||0.26|||||||Fisher’s non-parametric permutation test|||1000Hz|
1644347|NCT01822119|3023983|Superiority or Other|||||||0.79|||||||Fisher’s non-parametric permutation test|||500Hz|
1644348|NCT01822119|3023984|Superiority or Other|||||||0.39|||||||Fisher’s non-parametric permutation test||||
1644349|NCT01822119|3023985|Superiority or Other|||||||0.0632|||||||Fisher’s non-parametric permutation test|||Change at 8000Hz|
1644350|NCT01822119|3023985|Superiority or Other|||||||0.0499|||||||Fisher’s non-parametric permutation test|||Change at 6000Hz|
1644351|NCT01822119|3023985|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation test|||Statistically significant changes with the same value at 500 to 4000Hz|
1644352|NCT01822119|3023986|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation||||
1644353|NCT01822119|3023987|Superiority or Other||||||<|0.0001|||||||Fisher’s non-parametric permutation||||
1644354|NCT01821378|3024019|Superiority or Other||Least Square Mean Difference|-0.58||||0.003|2-Sided|95.0|-0.96|-0.2|||Mixed Models Analysis||||
1644355|NCT01821378|3024019|Superiority or Other||Least Square Mean Difference|-0.1||||0.578|2-Sided|95.0|-0.45|0.25|||Mixed Models Analysis||||
1644356|NCT01821378|3024020|Superiority or Other||Least Square Mean Difference|-7.3||||0.044|2-Sided|95.0|-14.4|-0.2|||Mixed Models Analysis||||
1644357|NCT01821378|3024020|Superiority or Other||Least Square Mean Difference|0.0||||0.992|2-Sided|95.0|-6.6|6.6|||Mixed Models Analysis||||
1644358|NCT01821378|3024021|Superiority or Other||Least Square Mean Difference|0.138|||<|0.001|2-Sided|95.0|0.081|0.194|||ANCOVA||||
1644359|NCT01821378|3024021|Superiority or Other||Least Square Mean Difference|0.084|||<|0.012|2-Sided|95.0|0.018|0.149|||ANCOVA||||
1644360|NCT01821378|3024022|Superiority or Other||Least Square Mean Difference|-0.35||||0.052|2-Sided|95.0|-0.7|0.0|||Mixed Models Analysis||||
1644361|NCT01821378|3024023|Superiority or Other||Slope|6.6|||<|0.001|2-Sided|95.0|3.2|10.1|||Mixed Models Analysis||||
1644362|NCT01821378|3024023|Superiority or Other||Least Square Mean Difference|2.3|||<|0.258|2-Sided|95.0|-1.7|6.2|||Mixed Models Analysis||||
1644363|NCT01821378|3024024|Superiority or Other||Least Square Mean Difference|-1.8||||0.122|2-Sided|95.0|-4.1|0.5|||ANCOVA||||
1644364|NCT01821378|3024024|Superiority or Other||Least Square Mean Difference|-0.8||||0.464|2-Sided|95.0|-2.9|1.3|||ANCOVA||||
1644365|NCT01821378|3024025|Superiority or Other||Least Square Mean Difference|-7.7||||0.023|2-Sided|95.0|-14.3|-1.1|||Mixed Models Analysis||||
1644366|NCT01821378|3024026|Superiority or Other||Odds Ratio (OR)|3.2|||<|0.001|2-Sided|95.0|2.0|5.2|||Regression, Logistic||||
1644367|NCT01821378|3024026|Superiority or Other||Odds Ratio (OR)|1.5|||<|0.173|2-Sided|95.0|0.8|2.5|||Regression, Logistic||||
1644368|NCT01821378|3024027|Superiority or Other||Least Square Mean Difference|-2.0||||0.003|2-Sided|95.0|-3.3|-0.7|||ANCOVA||||
1644369|NCT01821378|3024027|Superiority or Other||Least Square Mean Difference|-0.3||||0.706|2-Sided|95.0|-1.8|1.2|||ANCOVA||||
1644370|NCT01821378|3024028|Superiority or Other||Least Square Mean Difference|-0.57|||<|0.001|2-Sided|95.0|-0.83|-0.32|||Mixed Models Analysis||||
1644371|NCT01821378|3024028|Superiority or Other||Least Square Mean Difference|-0.2|||<|0.169|2-Sided|95.0|-0.49|0.09|||Mixed Models Analysis||||
1644372|NCT01821378|3024029|Superiority or Other||Least Square Mean Difference|-10.3|||<|-0.001|2-Sided|95.0|-14.9|-5.7|||Mixed Models Analysis||||
1644373|NCT01821378|3024029|Superiority or Other||Least Square Mean Difference|-3.1|||<|0.255|2-Sided|95.0|-8.4|2.2|||Mixed Models Analysis||||
1644374|NCT01821352|3024030|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1644375|NCT01821352|3024031|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1644376|NCT01821352|3024032|Superiority or Other||||||<|5e-05|||||||Fisher Exact||||
1644377|NCT01821118|3024056|Superiority or Other||Estimated Treatment Difference (log e)|0.0117|Standard Error of the Mean|0.034|||2-Sided|90.0|-0.046|0.0694||||||ROI2, Day 90: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.|
1644378|NCT01821118|3024056|Superiority or Other||Estimated Treatment Difference (log e)|0.0219|Standard Error of the Mean|0.0337|||2-Sided|90.0|-0.0352|0.079||||||ROI2, Day 2: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.|
1644379|NCT01821118|3024056|Superiority or Other||Estimated Treatment Difference (log e)|0.0737|Standard Error of the Mean|0.0383|||2-Sided|90.0|0.0084|0.139||||||ROI1, Day 90: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.|
1644380|NCT01821118|3024056|Superiority or Other||Estimated Treatment Difference (log e)|0.0464|Standard Error of the Mean|0.0395|||2-Sided|90.0|-0.0207|0.1136||||||ROI1, Day 2: Analysis of the change from baseline in log(time to return to baseline) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to return to baseline) at baseline was included as a covariate.|
1644509|NCT01816594|3024421|Superiority|||||||0.811|||||||Fisher Exact|(one-sided)||All participantss|
1644381|NCT01821118|3024057|Superiority or Other||Estimated Treatment Difference (log e)|-0.0888|Standard Error of the Mean|0.1061|||2-Sided|90.0|-0.2689|0.0914||||||ROI2, Day 90: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.|
1644382|NCT01821118|3024057|Superiority or Other||Estimated Treatment Difference (log e)|-0.0488|Standard Error of the Mean|0.0902|||2-Sided|90.0|-0.2018|0.1042||||||ROI2, Day 2: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.|
1644383|NCT01821118|3024057|Superiority or Other||Estimated Treatment Difference (log e)|-0.0859|Standard Error of the Mean|0.1165|||2-Sided|90.0|-0.2843|0.1124||||||ROI1, Day 90: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.|
1644384|NCT01821118|3024057|Superiority or Other||Estimated Treatment Difference (log e)|0.0602|Standard Error of the Mean|0.1281|||2-Sided|90.0|-0.1576|0.2781||||||ROI1, Day 2: Analysis of the change from baseline in log(amplitude) was carried out using a linear model (ANCOVA). Treatment was a fixed effect within the model and the log(amplitude) at baseline was included as a covariate.|
1644385|NCT01821118|3024058|Superiority or Other||Geometric Mean Ratio|1.01|Standard Error of the Mean|0.031|||2-Sided|90.0|0.96|1.063|||||SE of mean presented on log e scale.|ROI2, Day 90: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.|
1644386|NCT01821118|3024058|Superiority or Other||Geometric Mean Ratio|0.998|Standard Error of the Mean|0.032|||2-Sided|90.0|0.947|1.052|||||SE of mean presented on log e scale.|ROI2, Day 2: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.|
1644387|NCT01821118|3024058|Superiority or Other||Geometric Mean Ratio|1.049|Standard Error of the Mean|0.036|||2-Sided|90.0|0.99|1.114|||||SE of mean presented on log e scale.|ROI1, Day 90: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.|
1644388|NCT01821118|3024058|Superiority or Other||Geometric Mean Ratio|1.005|Standard Error of the Mean|0.046|||2-Sided|90.0|0.933|1.086|||||SE of mean presented on log e scale.|ROI1, Day 2: Analysis of the change from baseline in log(time to peak) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(time to peak) at baseline was included as a covariate.|
1644389|NCT01821118|3024059|Superiority or Other||Geometric Mean Ratio|0.902|Standard Error of the Mean|0.082|||2-Sided|90.0|0.788|1.031|||||SE of mean presented on log e scale.|ROI2: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.|
1644390|NCT01821118|3024059|Superiority or Other||Geometric Mean Ratio|0.852|Standard Error of the Mean|0.091|||2-Sided|90.0|0.735|0.989|||||SE of mean is presented on log e scale.|ROI1: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.|
1644391|NCT01821118|3024060|Superiority or Other||Geometric Mean Ratio|0.934|Standard Error of the Mean|0.075|||2-Sided|90.0|0.825|1.056|||||SE of mean is presented in log e scale.|ROI2: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.|
1644392|NCT01821118|3024060|Superiority or Other||Geometric Mean Ratio|0.984|Standard Error of the Mean|0.112|||2-Sided|90.0|0.82|1.184|||||SE of mean is presented in log e scale.|ROI1: Analysis of the change from baseline in log(slope) was carried out using a Bayesian linear model (ANCOVA). Treatment was a fixed effect within the model and the log(slope) at baseline was included as a covariate.|
1644393|NCT01819935|3024080|Superiority or Other||Hazard Ratio (HR)|1.24|||||2-Sided|95.0|1.06|1.45||||||Propensity Cox proportional hazards regression model was used.|
1644394|NCT01819935|3024081|Superiority or Other||Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.54|1.48||||||Propensity Cox proportional hazards regression model was used.|
1644395|NCT01819935|3024082|Superiority or Other||Hazard Ratio (HR)|0.88|||||2-Sided|95.0|0.68|1.13||||||Propensity Cox proportional hazards regression model was used.|
1644396|NCT01819935|3024083|Superiority or Other||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.68|1.37||||||Propensity Cox proportional hazards regression model was used.|
1644397|NCT01819935|3024084|Superiority or Other||Hazard Ratio (HR)|0.65|||||2-Sided|95.0|0.39|1.09||||||Propensity Cox proportional hazards regression model was used.|
1644398|NCT01819935|3024085|Superiority or Other||Hazard Ratio (HR)|1.02|||||2-Sided|95.0|0.9|1.15||||||Propensity Cox proportional hazards regression model was used.|
1644399|NCT01819935|3024086|Superiority or Other||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.53|1.05||||||Propensity Cox proportional hazards regression model was used.|
1644400|NCT01819935|3024087|Superiority or Other||Hazard Ratio (HR)|0.93|||||2-Sided|95.0|0.72|1.2||||||Propensity Cox proportional hazards regression model was used.|
1644401|NCT01819597|3024149|Other|This is a phase II study design to determine the non-futility of proceeding to a phase III pivotal evaluation. The study group was planned to be compared to a propensity score matching (PSM) cohort from to the patients in the medical arms of the SAMMPRIS trial and to patients in the medical arm of COSS that had demonstrated angiographic intracranial atherosclerosis and occlusion.|Hazard Ratio (HR)|0.38||||0.08|2-Sided|90.0|0.14|0.94||Pre-established α ≤ 0.10 for phase IIa|Regression, Cox|Alpha set at ≤ 0.1. for phase II study|ERSIAS/ Controls.|We derived the sample size required to power the trial to test the difference between two binomial event rates using the method of Farrington and Manning as implemented in R package gsDesign (Anderson, 2011). An estimated sample size of 52 patients will be necessary to detect a ∆ of 0.05, with a one-sided alpha of 0.10 and a beta of 0.10 - acceptable parameters for a non-definitive, non-futility study (Palesch et al., 2005, Levin, 2005).|
1644402|NCT01819506|3024152|Superiority|||||||0.912|||||||ANOVA||||
1644510|NCT01816477|3024422|Superiority or Other|||||||0.7166|||||||Unequal Variance T-Test|||Comparison between groups for day 6.|
1644403|NCT01819272|3024162|Superiority or Other||LS Mean|-0.67||||0.0006|2-Sided|95.0|-1.04|-0.29|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate|||
1644404|NCT01819272|3024162|Superiority or Other||LS Mean|-0.45||||0.0188|2-Sided|95.0|-0.83|-0.08|||ANCOVA|Factor for treatment and baseline HbA1c as acovariate|||
1644405|NCT01819272|3024162|Superiority or Other||LS Mean|-0.35||||0.0611|2-Sided|95.0|-0.71|0.02|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate|||
1644406|NCT01819272|3024162|Superiority or Other||LS Mean|-0.45||||0.0153|2-Sided|95.0|-0.81|-0.09|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate|||
1644407|NCT01819272|3024162|Superiority or Other||LS Mean|-0.48||||0.01|2-Sided|95.0|-0.85|-0.12|||ANCOVA|Factor for treatment and baseline HbA1c as a covariate|||
1644408|NCT01819272|3024163|Superiority or Other||Hodges-Lehmann Estimation|-224.0|||<|0.0001|2-Sided|95.0|-334.0|-118.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis||||
1644409|NCT01819272|3024163|Superiority or Other||Hodges-Lehmann Estimation|-101.0|||<|0.0405|2-Sided|95.0|-208.0|-4.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis||||
1644410|NCT01819272|3024163|Superiority or Other||Hodges-Lehmann Estimation|-152.0|||<|0.0071|2-Sided|95.0|-252.0|-42.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis||||
1644411|NCT01819272|3024163|Superiority or Other||Hodges-Lehmann Estimation|-106.0|||<|0.0068|2-Sided|95.0|-180.0|-32.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis||||
1644412|NCT01819272|3024163|Superiority or Other||Hodges-Lehmann Estimation|-106.0|||<|0.0226|2-Sided|95.0|-208.0|-16.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis||||
1644413|NCT01819272|3024164|Superiority or Other||Hodges-Lehmann Estimation|-28.0|||<|0.0001|2-Sided|95.0|-42.0|-17.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis||||
1644414|NCT01819272|3024164|Superiority or Other||Hodges-Lehmann Estimation|-12.0|||<|0.0097|2-Sided|95.0|-23.0|-3.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis||||
1644415|NCT01819272|3024164|Superiority or Other||Hodges-Lehmann Estimation|-12.0|||<|0.1095|2-Sided|95.0|-25.0|3.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis||||
1644416|NCT01819272|3024164|Superiority or Other||Hodges-Lehmann Estimation|-14.0|||<|0.0057|2-Sided|95.0|-22.0|-4.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis||||
1644417|NCT01819272|3024164|Superiority or Other||Hodges-Lehmann Estimation|-9.0|||<|0.067|2-Sided|95.0|-21.0|1.0||p-value for pair-wise comparison without adjustment|Kruskal-Wallis||||
1644418|NCT01819129|3024180|Non-Inferiority or Equivalence|The assessment was done by comparing the difference of faster aspart vs. NovoRapid®/NovoLog® in change from baseline in HbA1c after 26 weeks of randomized treatment to a non-inferiority limit of 0.4%.|Mean Difference (Net)|-0.02|||||2-Sided|95.0|-0.15|0.1|||||The estimated parameter i.e mean difference is the estimated treatment difference for Faster aspart vs. NovoRapid (Faster aspart - NovoRapid).|Change from baseline in HbA1c is analysed using a mixed-effect model for repeated measurements including changes from baseline in HbA1c at visit 14, 18, 22, 26, 30 and 36. The model includes treatment, region and continuous glucose monitoring (CGM) strata as fixed effects, subject as random effect, HbA1c at baseline as covariate and interaction between all fixed effects and visit, and between the covariate and visit.|
1644419|NCT01818752|3024190|Superiority or Other||Least squares mean difference|4.99|Standard Error of the Mean|0.773|<|0.0001|2-Sided|95.0|3.48|6.51||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Mixed Effects Model for Repeated Measure|||Treatment groups were compared using a linear mixed model for repeated measures (MMRM). The model included the fixed, categorical effects of treatment (all baseline responses were modeled with a dummy treatment), the randomization stratification factors – ISS stage, choice of route of bortezomib administration, region, age, and random effects of subject intercept and coefficient on time.|
1644420|NCT01818752|3024191|Superiority or Other||Odds Ratio (OR)|0.048|||<|0.0001|2-Sided|95.0|0.026|0.088||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Pearson Chi-Square test||Unstratified odds ratio (Carfilzomib/Bortezomib) was estimated.||
1644421|NCT01818752|3024192|Superiority or Other||Odds Ratio (OR)|1.179||||0.1388|2-Sided|95.0|0.875|1.589||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-square test stratified by ISS stage, choice of route of bortezomib administration, region and age.|Odds ratio (Carfilzomib/Bortezomib) was estimated using the Mantel-Haenszel method stratified by ISS stage, choice of route of bortezomib administration, region and age.||
1644422|NCT01818752|3024193|Superiority or Other||Odds Ratio (OR)|1.412||||0.0218|2-Sided|95.0|1.01|1.973||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-square test stratified by ISS stage, choice of route of bortezomib administration, region and age.|Odds ratio (Carfilzomib/Bortezomib) was estimated using the Mantel-Haenszel method stratified by ISS stage, choice of route of bortezomib administration, region and age.||
1644423|NCT01818752|3024194|Superiority or Other||Hazard Ratio (HR)|1.211||||0.8934|2-Sided|95.0|0.896|1.637||Based on the pre-specified multiplicity adjustment method, secondary endpoints were to be tested only if the results of the primary endpoint were significant. The p-values for all secondary endpoints are descriptive only.|Log Rank|Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.|The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.||
1644446|NCT01817959|3024274|Superiority||least square mean difference|0.056||||0.2537|2-Sided|95.0|-0.042|0.154||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 365 (last Transplant)|
1644447|NCT01817959|3024274|Superiority||least square mean difference|0.028||||0.556|2-Sided|95.0|-0.068|0.124||This is a treatment p value|ANCOVA|||This is is the analytic statistics for Day 75 (Transplant 2)|
1644984|NCT01802554|3025783|Superiority or Other|||||||0.021|||||||Mixed Models Analysis||||
1644424|NCT01818752|3024195|Superiority or Other||Hazard Ratio (HR)|0.906||||0.159|2-Sided|95.0|0.746|1.101||The p-value boundary for PFS analysis was 0.02141.|Log Rank|Log-rank p-value (1-sided) stratified by ISS stage, choice of route of bortezomib administration, region and age.|The hazard ratio (Carfilzomib/Bortezomib) was estimated using a Cox proportional hazards model stratified by ISS stage, choice of route of bortezomib administration, region and age.|The inferential test associated with the primary analysis of PFS was assessed against an overall 1-sided significance level of α=0.025.|
1644425|NCT01818700|3024204|Superiority or Other||Mean Difference (Final Values)|-1.65|Standard Deviation|1.96|<|0.05|2-Sided|95.0|-10.0|10.0|||t-test, 2 sided|"The primary endpoint will be the actual reduction rate of pain intensity (0 -10) score at 8 weeks.~It will be analyzed by using paired t-test."|||
1644426|NCT01818596|3024222|Non-Inferiority or Equivalence (legacy)|30 participants with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is < 20% after participants were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-participant variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.|Difference in GLSM Ratio|102.66|||||2-Sided|90.0|97.11|108.53|||||A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.|Comparison is made between the baseline value and the value from the Week 24 visit and presented as a GLSM ratio with 90% CI. Week 24 value and baseline value were used as test and reference, respectively.|
1644427|NCT01818596|3024222|Non-Inferiority or Equivalence (legacy)|30 participants with evaluable aGFR (measured by iohexol clearance) in either cohort would provide at least 90% power to show that aGFR change is < 20% after participants were administered E/C/F/TAF. In this sample size/power computation, it was assumed that the intra-participant variation for aGFR is 0.17 mL/min on natural logarithm scale and a clinical meaningful boundary in aGFR change is 80% to 125%.|Difference in GLSM Ratio|98.94|||||2-Sided|90.0|93.71|104.46|||||A parametric analysis of variance model using a mixed-effects model with repeated statement was fitted to the natural logarithm transferred aGFR obtained at postbaseline visits and baseline.|Comparison is made between the baseline value and the value from the Week 2, 4, or 8 visit and presented as a geometric least squares mean (GLSM) ratio with 90% confidence interval (CI). Postbaseline value and baseline value were used as test and reference, respectively.|
1644428|NCT01818414|3024240|Superiority or Other|||||||0.052|||||||t-test, 2 sided||||
1644429|NCT01818414|3024241|Superiority or Other|||||||0.17|||||||t-test, 2 sided||||
1644430|NCT01818297|3024248|Superiority||Risk Difference (RD)|11.5|Standard Error of the Mean|10.5||0.14|1-Sided|95.0|-5.8|||Due to early termination, the study was insufficiently powered to test the primary objective. This analysis is exploratory and descriptive in nature and cannot be considered conclusive.|Z-test|The Z-test (using an unpooled standard deviation, without continuity correction) was used to test the difference in responder rates between groups.|The Estimation Parameter is the difference between the responder rates in the Treatment and Control groups. The difference is calculated as Treatment - Control. A positive number represents a higher responder rate in the Treatment group.|The original sample size estimate for the primary objective was based on the following assumptions: 109 subjects in each arm with a responder rate of 22% in the Control group and 40% in the Treatment group, and a one-sided α= 0.05 using a Z test with unpooled variance, would result in 90% power. Because the study terminated early, the actual sample size (32 in Treatment, 30 in Control) resulted in 47% power under the same assumptions.|
1644431|NCT01817959|3024266|Superiority||Least square mean difference|-0.177||||0.1059|2-Sided|95.0|-0.393|0.039||This is the analytic statistics for Day 75 (Transplant 2)|ANOVA|||This is the analytic statistics for Day 365 (last Transplant)|
1644432|NCT01817959|3024266|Superiority||Least square mean difference|-0.218||||0.0328|2-Sided|95.0|-0.417|-0.019||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 2)|
1644433|NCT01817959|3024266|Superiority||Least square mean difference|-0.105||||0.2444|2-Sided|95.0|-0.286|0.075||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 1)|
1644434|NCT01817959|3024267|Superiority||Least square mean difference|-0.59||||0.3955|2-Sided|95.0|-1.97|0.8||Treatment p value|ANOVA|||This is the analytic statistics for Day 365 (last Transplant)|
1644435|NCT01817959|3024267|Superiority||Least square mean difference|0.1||||0.8753|2-Sided|95.0|-1.18|1.38||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 2)|
1644436|NCT01817959|3024267|Superiority||Least square mean difference|0.0||||0.9949|2-Sided|95.0|-1.28|1.28||Treatment p value|ANOVA|||This is the analytic statistics for Day 75 (Transplant 1)|
1644437|NCT01817959|3024271|Superiority||least square mean difference|1.9||||0.6583|2-Sided|95.0|-6.6|10.4||Treatment p value|ANCOVA|||This is the analytic statistics for Day 365 (last Transplant)|
1644438|NCT01817959|3024271|Superiority||least square mean difference|1.0||||0.7853|2-Sided|95.0|-6.3|8.3||Treatment p value|ANCOVA|||This is the analytic statistics for Day 75 (Transplant 2)|
1644439|NCT01817959|3024271|Superiority||least square mean difference|2.0||||0.429|2-Sided|95.0|-3.0|6.9||Treatment p value|ANCOVA|||This is the analytic statistics for Day 75 (Transplant 1)|
1644440|NCT01817959|3024272|Superiority||Least square mean difference|0.17||||0.6437|2-Sided|95.0|-0.56|0.93||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 365 (last Transplant)|
1644441|NCT01817959|3024272|Superiority||least square mean difference|0.16||||0.6069|2-Sided|95.0|-0.46|0.78||Treatment p value|least square mean difference|||This is the analytic statics for Day 75 (Transplant 2)|
1644442|NCT01817959|3024272|Superiority||least square mean difference|0.21||||0.3253|2-Sided|95.0|-0.21|0.63||Treatment p value|ANCOVA|||This is the analytic statics for Day 75 (Transplant 1)|
1644443|NCT01817959|3024273|Superiority||least square mean difference|6.1||||0.5005|2-Sided|95.0|-12.1|24.4||Treatment p value|ANCOVA|||This is the analytic statics for Day 365 (last Transplant)|
1644444|NCT01817959|3024273|Superiority||least square mean difference|4.2||||0.5966|2-Sided|95.0|-11.8|20.2||Treatment p value|ANCOVA|Treatment p value||This is the analytic statics for Day 75 (Transplant 2)|
1644445|NCT01817959|3024273|Superiority||least square mean difference|-7.4||||0.591|2-Sided|95.0|-35.2|20.3||Treatment p value|ANCOVA|||This is the analytic statics for Day 75 (Transplant 1)|
1644503|NCT01816594|3024415|Superiority|||||||0.811|||||||Fisher Exact|(one-sided)|||
1644448|NCT01817959|3024274|Superiority||least square mean difference|-0.021||||0.6952|2-Sided|95.0|-0.13|0.088||Treatment p value|ANCOVA|||This is is the analytic statistics for Day 75 (Transplant 1)|
1644449|NCT01817959|3024276|Superiority|||||||0.1383|||||||Fisher Exact||||
1644450|NCT01817959|3024277|Superiority||Odds Ratio (OR)|0.65||||0.5467|2-Sided|95.0|0.16|2.66||Treatment p value|Regression, Logistic||||
1644451|NCT01817959|3024278|Superiority||Odds Ratio (OR)|0.91||||0.913|2-Sided|95.0|0.17|4.93||Treatment p value|Regression, Logistic||||
1644452|NCT01817959|3024279|Superiority||Odds Ratio, log|0.21||||0.1346|2-Sided|95.0|0.03|1.63||Treatment p value|Regression, Logistic|||Analytical statistics are reported for Day 75 after transplant 2|
1644453|NCT01817959|3024280|Superiority||least square mean difference|0.024||||0.7115|2-Sided|99.75|-0.184|0.232||Treatment p value|ANOVA||||
1644454|NCT01817959|3024281|Superiority||least square mean difference|0.001||||0.9863|2-Sided|99.75|-0.205|0.207||Treatment p value|ANOVA||||
1644455|NCT01817907|3024282|Superiority or Other|||||||0.52|||||||t-test, 2 sided||||
1644456|NCT01817790|3024288|Superiority or Other||Least Square Mean Difference|-0.42|||<|0.0001|2-Sided|95.0|-0.64|-0.21||p-value was not adjusted for multiple comparisons.|ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in 'Other Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.|
1644457|NCT01817790|3024289|Superiority or Other||Least Square Mean Difference|-0.44|||<|0.0001|2-Sided|95.0|-0.65|-0.23||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Eye Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.|
1644458|NCT01817790|3024290|Superiority or Other||Least Square Mean Difference|-0.53|||<|0.0001|2-Sided|95.0|-0.73|-0.33||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Nose Symptoms' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.|
1644459|NCT01817790|3024291|Superiority or Other||Least Square Mean Difference|-0.44|||<|0.0001|2-Sided|95.0|-0.64|-0.24||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Practical Problems' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray.|
1644460|NCT01817790|3024292|Superiority or Other||Least Square Mean Difference|-0.49|||<|0.0001|2-Sided|95.0|-0.68|-0.3||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in 'Activities' domain of MiniRQLQ scores between the Flutical sone nasal spray and placebo nasal spray|
1644461|NCT01817790|3024293|Superiority or Other||Least Square Mean Difference|-0.47|||<|0.0001|2-Sided|95.0|-0.65|-0.29||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in MiniRQLQ scores between the Fluticasone nasal spray and the placebo nasal spray.|
1644462|NCT01817790|3024294|Superiority or Other||Least Square Mean Difference|-0.01||||0.8586|2-Sided|95.0|-0.12|0.1|||ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in objective assessment of conjunctival redness between the Fluticasone nasal spray and the placebo nasal spray.|
1644463|NCT01817790|3024295|Superiority or Other|||||||0.0118||||||p-value was not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Using this test controlling for investigative site. The response variable lied on ordinal scale of measurement.||Null hypothesis was that no difference exists in the end of treatment assessment of response between the Fluticasone nasal spray and the placebo nasal spray.|
1644464|NCT01817790|3024296|Superiority or Other||Least Square Mean Difference|-0.14||||0.0002|2-Sided|95.0|-0.22|-0.07||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in rNCSS between the Fluticasone nasal spray and the placebo nasal spray.|
1644465|NCT01817790|3024297|Superiority or Other||Least Square Mean Difference|-0.28||||0.0129|2-Sided|95.0|-0.5|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM iTOSS between the Fluticasone nasal spray and the placebo nasal spray.|
1644466|NCT01817790|3024298|Superiority or Other||Least Square Mean Difference|-0.1||||0.0361||95.0|-0.19|-0.01||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.|
1644467|NCT01817790|3024299|Superiority or Other||Least Square Mean Difference|-0.1||||0.0304||95.0|-0.18|-0.01||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Redness between the Fluticasone nasal spray and the placebo nasal spray.|
1644468|NCT01817790|3024300|Superiority or Other||Least Square Mean Difference|-0.18|||<|0.0001||95.0|-0.26|-0.09||p-value was nor adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye Tearing/watering between the Fluticasone nasal spray and the placebo nasal spray.|
1644469|NCT01817790|3024301|Superiority or Other||Least Square Mean Difference|-0.13||||0.0023||95.0|-0.22|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye Tearing/Watering between the Fluticasone nasal spray and the placebo nasal spray.|
1644504|NCT01816594|3024416|Superiority|||||||0.929|||||||Fisher Exact|(one-sided)||mutant cohort|
1644505|NCT01816594|3024417|Superiority|||||||0.177|||||||Fisher Exact|(one-sided)||wild type cohort|
1644470|NCT01817790|3024302|Superiority or Other||Least Square Mean Difference|-0.15||||0.0005||95.0|-0.23|-0.06||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.|
1644471|NCT01817790|3024303|Superiority or Other||Least Square Mean Difference|-0.1||||0.0117|2-Sided|95.0|-0.19|-0.02||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM reflective symptom scores for Eye itching/burning between the Fluticasone nasal spray and the placebo nasal spray.|
1644472|NCT01817790|3024304|Superiority or Other||Least Square Mean Difference|-0.41||||0.0009||95.0|-0.65|-0.17||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in PM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.|
1644473|NCT01817790|3024305|Superiority or Other||Least Square Mean Difference|-0.33||||0.0057|2-Sided|95.0|-0.56|-0.1||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in AM rTOSS between the Fluticasone nasal spray and the placebo nasal spray.|
1644474|NCT01817790|3024306|Superiority or Other||Least Square Mean Difference|-0.36||||0.0024|2-Sided|95.0|-0.59|-0.13||p-value was not adjusted for multiple comparisons.|ANCOVA|Linear Fixed-effect Model; Treatment and site as fixed factors and baseline score as covariate.||Null hypothesis was that no difference exists in the mean change from baseline in Daily rTOSS between the Fluticasone nasal spray and the placebo nasal spray.|
1644475|NCT01817764|3024317|Superiority or Other||Mean Difference (Net)|0.074|||<|0.001|2-Sided|95.0|0.038|0.11|||ANCOVA||||
1644476|NCT01817725|3024319|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1644477|NCT01817712|3024320|Other|Longitudinal analysis of PCL-5 (change from baseline)|Mean Difference (Net)|-1.9||||0.07|2-Sided|95.0|-3.91|0.12|||Mixed Models Analysis||||
1644478|NCT01817712|3024321|Superiority|||||||0.004|||||||Kruskal-Wallis|Site used as strata|||
1644479|NCT01817712|3024322|Superiority||Odds Ratio (OR)|2.14|||<|0.001|2-Sided|95.0|1.46|3.14|||Regression, Logistic||||
1644480|NCT01817582|3024340|Other||LS mean difference|-0.5||||0.8836|2-Sided|95.0|-7.7|6.7||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.|
1644481|NCT01817582|3024340|Other||LS mean difference|-4.9||||0.189|2-Sided|95.0|-12.3|2.5||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.|
1644482|NCT01817582|3024340|Other||LS mean difference|-4.4||||0.2296|2-Sided|95.0|-11.6|2.8||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.|
1644483|NCT01817582|3024341|Other||LS mean difference|-0.1||||0.8068|2-Sided|95.0|-1.1|0.9||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.|
1644484|NCT01817582|3024341|Other||LS mean difference|0.1||||0.807|2-Sided|95.0|-0.9|1.2||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.|
1644485|NCT01817582|3024341|Other||Least square (LS) mean difference|0.3||||0.6199|2-Sided|95.0|-0.7|1.3||Threshold for significance at 0.05 level.|Mixed Models Analysis|||Analysis was performed using MMRM method.|
1644486|NCT01816776|3024392|Superiority||Mean Difference (Net)|-3.7|||<|0.0001|2-Sided|95.0|-5.5|-2.0||1-sided. Secondary endpoints hierarchically tested with p<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment – Control||
1644487|NCT01816776|3024393|Superiority||Mean Difference (Net)|-22.7|||<|0.0001|2-Sided|95.0|-28.9|-16.5||Secondary endpoints hierarchically tested with p<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment – Control||
1644488|NCT01816776|3024394|Superiority||Risk Difference (RD)|55.0|||<|0.0001|2-Sided|95.0|40.0|68.0||1-sided. Secondary endpoints hierarchically tested with p<0.025 considered significant.|Fisher Exact||Risk difference = Treatment – Control||
1644489|NCT01816776|3024395|Superiority||Mean Difference (Net)|2.4||||0.0244|2-Sided|95.0|-0.4|5.1||1-sided. Secondary endpoints hierarchically tested with p<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment – Control||
1644490|NCT01816776|3024396|Superiority||Mean Difference (Net)|-15.2|||<|0.0001|2-Sided|95.0|-21.6|-8.7||Secondary endpoints hierarchically tested with p<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment – Control||
1644491|NCT01816776|3024397|Superiority||Mean Difference (Net)|-25.0|||<|0.0001|2-Sided|95.0|-31.2|-18.7||Secondary endpoints hierarchically tested with p<0.025 considered significant.|t-test, 1 sided||Mean difference = Treatment – Control||
1644492|NCT01816776|3024398|Superiority||Mean Difference (Net)|-22.8|||<|0.0001|2-Sided|95.0|-29.0|-16.6||1-sided. Secondary endpoints hierarchically tested with p<0.025 considered significant.|Wilcoxon (Mann-Whitney)||Mean difference = Treatment – Control||
1644493|NCT01816776|3024400|Superiority||Risk Difference (RD)|41.0|||<|0.0001|2-Sided|95.0|25.0|54.0||1-sided. p<0.025 considered significant.|Fisher Exact||Risk difference = Treatment – Control||
1644494|NCT01816594|3024406|Superiority|||||||0.803|||||||Fisher Exact|(one-sided)|||
1644495|NCT01816594|3024407|Superiority|||||||0.666|||||||Fisher Exact|(one-sided)|||
1644496|NCT01816594|3024408|Superiority|||||||0.949|||||||Fisher Exact|(one-sided)||For ER- participants - ORR|
1644497|NCT01816594|3024409|Superiority|||||||0.053|||||||Fisher Exact|(one-sided)||For ER+ participants - ORR|
1644498|NCT01816594|3024410|Superiority|||||||0.949|||||||Fisher Exact|(one-sided)||For ER- participants - pCR|
1644499|NCT01816594|3024411|Superiority|||||||0.546|||||||Fisher Exact|(one-sided)||For ER+ participants - pCR|
1644500|NCT01816594|3024412|Superiority|||||||0.964|||||||Fisher Exact|(one-sided)||All participants|
1644501|NCT01816594|3024413|Superiority|||||||0.724|||||||Fisher Exact|(one-sided)|||
1644502|NCT01816594|3024414|Superiority|||||||0.84|||||||Fisher Exact|(one-sided)|||
1644511|NCT01816477|3024422|Superiority or Other|||||||0.5314|||||||Unequal Variance T-Test|||Comparison between groups for day 5.|
1644512|NCT01816477|3024422|Superiority or Other|||||||0.1036|||||||Unequal Variance T-Test|||Comparison between the groups for day 4.|
1644513|NCT01816477|3024422|Superiority or Other|||||||0.5788|||||||Unequal Variance T-Test|||Comparison between groups for day 3.|
1644514|NCT01816477|3024422|Superiority or Other|||||||0.9233|||||||Unequal Variance T-Test|||Comparison between groups for day 2.|
1644515|NCT01816477|3024422|Superiority or Other|||||||0.6465|||||||Unequal Variance T-Test|||Comparison between the groups for day 1.|
1644516|NCT01816477|3024423|Superiority or Other|||||||0.0484|||||||Unequal Variance T-Test|||Comparison between groups for day 6.|
1644517|NCT01816477|3024423|Superiority or Other|||||||0.0625|||||||Unequal Variance T-Test|||Comparison between groups for day 5|
1644518|NCT01816477|3024423|Superiority or Other|||||||0.3582|||||||Unequal Variance T-Test|||Comparison between groups for day 4.|
1644519|NCT01816477|3024423|Superiority or Other|||||||0.1203|||||||Unequal Variance T-Test|||Comparison between groups for day 3.|
1644520|NCT01816477|3024423|Superiority or Other|||||||0.6751|||||||Unequal Variance T-Test|||Comparison between groups for day 2.|
1644521|NCT01816477|3024423|Superiority or Other|||||||0.0872|||||||Unequal Variance T-Test|||Comparison between the groups for day 1.|
1644522|NCT01816477|3024424|Superiority or Other|||||||0.55|||||||t-test, 2 sided||||
1644523|NCT01816451|3024436|Superiority or Other||||||<|0.05|||||||ANOVA|||For pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post training data were expressed as mean and standard deviation. HR and [La], were by three-way ANOVA (Measure x Group x Time) with repeated measures for the factors Measure and Time. The variables RPE, Velocity were made two-way ANOVAs (Group x Measure) with repeated measures on the factor Measure. Where the ANOVA was significant, the Tukey-Kramer as post-hoc was used. Control didn't do submaximal test for training intensities.|
1644524|NCT01816451|3024436|Superiority or Other||||||<|0.05|||||||ANOVA|||For pre-post training variables data were expressed as mean and standard deviation. Heart Rate and Blood Lactate, were by three-way ANOVA (Measure x Group x Time) with repeated measures for the factors Measure and Time. The variables absolute and relative VO2, tVO2, Body Fat, Body Mass, RPE, were made two-way ANOVAs (Group x Measure) with repeated measures on the factor Measure. Where the ANOVA was significant, the Tukey-Kramer as post-hoc was used.|
1644525|NCT01816295|3024438|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.39||0.905|2-Sided|95.0|-0.82|0.72|||ANCOVA|||Change from Baseline to Week 36|
1644526|NCT01816295|3024438|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.34||0.442|2-Sided|95.0|-0.94|0.41|||ANCOVA|||Change from Baseline to Week 12|
1644527|NCT01816295|3024439|Superiority or Other||Mean Difference (Net)|2.9|Standard Error of the Mean|1.25||0.019|2-Sided|99.5|-0.59|6.45|||ANCOVA||||
1644528|NCT01816295|3024440|Superiority or Other||Mean Difference (Net)|5.1|Standard Error of the Mean|1.42|<|0.001|2-Sided|99.5|1.05|9.07|||ANCOVA||||
1644529|NCT01816295|3024441|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1644530|NCT01815840|3024477|Superiority or Other||Mean Difference (Final Values)|-8.3|||||2-Sided|95.0|-22.2|5.7|||||Asymptotic confidence intervals are presented for the difference between treatment arms.|The mean difference in the mean relative reduction between treatment arms, along with the corresponding 95% confidence interval, was estimated by fitting an ANCOVA model with treatment as main effect and the following covariates: number of basal cell carcinomas at baseline, geographical region, immunosuppression status, confirmed basal cell carcinoma nevus syndrome.|
1644531|NCT01815736|3024478|Superiority or Other (legacy)||||||<|0.001||||||The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||All Participants|
1644532|NCT01815736|3024478|Superiority or Other (legacy)||||||<|0.001||||||The P-value comparing the 2 treatment groups was from the 2-sided Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||NDA Data Cut|
1644533|NCT01815736|3024479|Superiority or Other (legacy)||Difference in least square means|-0.04|||<|0.001|2-Sided|95.0|-0.05|-0.02||P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.|ANCOVA||Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.|All Participants|
1644534|NCT01815736|3024479|Superiority or Other (legacy)||Difference in least square means|-0.05|||<|0.001|2-Sided|95.0|-0.07|-0.03||P-value was from analysis of covariance (ANCOVA) model including study treatment and prior treatment as fixed effects and baseline serum creatinine as a covariate.|ANCOVA||Difference in least squares means (LSM) and its 95% CI were from the analysis of covariance (ANCOVA) model including study treatment and prior treatment regimen as fixed effects and baseline serum creatinine as a covariate.|NDA Data Cut|
1644535|NCT01815736|3024480|Superiority or Other (legacy)||Difference in least square means|2.0|||<|0.001|2-Sided|95.0|1.549|2.452||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|All Participants|
1644536|NCT01815736|3024480|Superiority or Other (legacy)||Difference in least square means|1.97|||<|0.001|2-Sided|95.0|1.551|2.39||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|NDA Data Cut|
1644537|NCT01815736|3024481|Superiority or Other (legacy)||Difference in least square means|1.807|||<|0.001|2-Sided|95.0|1.488|2.126||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|All Participants|
1644587|NCT01814748|3024653|Superiority or Other||Difference in least squares means|0.12||||0.535|2-Sided|95.0|-0.26|0.49|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|||
1644538|NCT01815736|3024481|Superiority or Other (legacy)||Difference in least square means|2.078|||<|0.001|2-Sided|95.0|1.697|2.459||P-value was from the analysis of variance (ANOVA) model including study treatment and prior treatment regimen as fixed effects.|ANOVA||Difference in least squares means (LSM) and its 95% CI were from the ANOVA model including treatment and prior treatment regimen as fixed effects.|NDA Data Cut|
1644539|NCT01815736|3024482|Non-Inferiority or Equivalence (legacy)|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|4.1|||<|0.001|2-Sided|95.0|1.6|6.7||The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.|Cochran-Mantel-Haenszel||The difference in percentages and its 95% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.|All Participants|
1644540|NCT01815736|3024482|Non-Inferiority or Equivalence (legacy)|Null hypothesis: the E/C/F/TAF group was at least 12% worse than the Stay on Baseline Regimen group; alternative hypothesis: the E/C/F/TAF group was less than 12% worse than the in Stay on Baseline Regimen group.|Difference in percentages|2.7|||<|0.051|2-Sided|95.01|-0.3|5.6||The p-value for the superiority test used a 2-sided Cochran-Mantel-Haenszel (CMH) test, stratified by prior treatment regimen.|Cochran-Mantel-Haenszel||The difference in percentages and its 95.01% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportion adjusted by the prior treatment regimen.|NDA Data Cut|
1644541|NCT01815424|3024542|Superiority or Other||Least square mean of difference|-22.89|Standard Error of the Mean|16.01||0.1558|2-Sided|95.0|-54.64|8.86||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644542|NCT01815424|3024542|Superiority or Other||Least square mean of difference|-41.23|Standard Error of the Mean|15.977||0.0113|2-Sided|95.0|-72.91|-9.54||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644543|NCT01815424|3024543|Superiority or Other||Least square mean difference|-4.2|Standard Error of the Mean|0.706|<|0.0001|2-Sided|95.0|-5.59|-2.81||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644544|NCT01815424|3024543|Superiority or Other||Least square mean difference|-5.09|Standard Error of the Mean|0.709|<|0.0001|2-Sided|95.0|-6.49|-3.7||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 4. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644545|NCT01815424|3024544|Superiority or Other|||||||0.0386||||||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|OR and 95% CI not available due to 0% frequency in placebo group.||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644546|NCT01815424|3024544|Superiority or Other||||||<|0.0001||||||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|OR and 95% CI not available due to 0% frequency in placebo group.||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644588|NCT01814696|3024658|Superiority or Other|||||||0.002|||||||t-test, 2 sided||||
1644589|NCT01814696|3024659|Superiority or Other|||||||0.21|||||||Wilcoxon rank-sum test|||Non heart failure related|
1644590|NCT01814696|3024659|Superiority or Other|||||||0.196|||||||Wilcoxon rank-sum test|||Heart failure related|
1644591|NCT01814696|3024659|Superiority or Other|||||||0.034|||||||Wilcoxon rank-sum test|||All cause|
1644592|NCT01814696|3024660|Superiority or Other|||||||0.236|||||||Wilcoxon rank-sum test|||Non heart failure related|
1644547|NCT01815424|3024545|Superiority or Other||Odds Ratio (OR)|35.37|||<|0.0001|2-Sided|95.0|3.47|1084.02||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644548|NCT01815424|3024545|Superiority or Other||Odds Ratio (OR)|114.4|||<|0.0001|2-Sided|95.0|8.95|2657.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant,only then subsequent comparison was tested at the below specified significance level.|
1644549|NCT01815424|3024546|Superiority or Other||Least square mean difference|-5.45|Standard Error of the Mean|0.907|<|0.0001|2-Sided|95.0|-7.24|-3.67||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644550|NCT01815424|3024546|Superiority or Other||Least square mean difference|-7.52|Standard Error of the Mean|0.913|<|0.0001|2-Sided|95.0|-9.32|5.72||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||Week 16. This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644551|NCT01815424|3024547|Superiority or Other||Odds Ratio (OR)|16.44|||<|0.0001|2-Sided|95.0|4.31|79.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644552|NCT01815424|3024547|Superiority or Other||Odds Ratio (OR)|70.31|||<|0.0001|2-Sided|95.0|13.38|267.15||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644553|NCT01815424|3024548|Superiority or Other||Least Square Mean Difference|-52.12|Standard Error of the Mean|8.416|<|0.0001|2-Sided|95.0|-68.7|-35.55||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance level of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644554|NCT01815424|3024548|Superiority or Other||Least Square Mean Difference|-71.54|Standard Error of the Mean|8.461|<|0.0001|2-Sided|95.0|-88.2|-54.87||Mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value, and a random effect of subject; unstructured covariance matrix was used. Each hypothesis was tested at a significance of 0.025 (2-sided).|Mixed Models Analysis|||This is a key secondary endpoint; family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644555|NCT01815424|3024549|Superiority or Other||Odds Ratio (OR)|9.97|||<|0.0001|2-Sided|95.0|4.06|25.17||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644593|NCT01814696|3024660|Superiority or Other|||||||0.236|||||||Wilcoxon rank-sum test|||Heart failure related|
1644556|NCT01815424|3024549|Superiority or Other||Odds Ratio (OR)|41.71|||<|0.0001|2-Sided|95.0|14.84|151.11||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644557|NCT01815424|3024550|Superiority or Other||Odds Ratio (OR)|5.27|||<|0.0001|2-Sided|95.0|2.46|11.86||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644558|NCT01815424|3024550|Superiority or Other||Odds Ratio (OR)|14.52|||<|0.0001|2-Sided|95.0|6.03|32.77||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at a significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for tofacitinib 10 mg vs placebo at Week 16; PASI75 response for tofacitinib 10 mg vs placebo at Week 16; PGA response for tofacitinib 5 mg vs placebo at Week 16; PASI75 response for tofacitinib 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparison was tested at the below specified significance level.|
1644559|NCT01815229|3024552|Other||||||<|0.05||||||P value applies to cell count at removal|t-test, 2 sided|||Tracheal lavages (TL) were done in intubated humans to obtain cell counts.|
1644560|NCT01815138|3024554|Superiority|||||||0.04|||||||t-test, 2 sided||||
1644561|NCT01815138|3024555|Other||Odds Ratio (OR)|0.05|||<|0.05|2-Sided||||||Fisher Exact||||
1644562|NCT01814878|3024562|Superiority or Other|||||||0.2848||||||Day 3: P-value was calculated using student's t-test|Student's t-test||||
1644563|NCT01814878|3024563|Superiority or Other|||||||0.3255||||||P-value was calculated using Mann-Whitney’s U test.|Wilcoxon (Mann-Whitney)||||
1644564|NCT01814878|3024564|Superiority or Other|||||||0.1||||||P-value was calculated using Mann-Whitney’s U test.|Wilcoxon (Mann-Whitney)||||
1644565|NCT01814878|3024565|Superiority or Other|||||||0.4216||||||P-value was calculated using Mann-Whitney’s U test.|Wilcoxon (Mann-Whitney)||||
1644566|NCT01814878|3024566|Superiority or Other|||||||0.121||||||Hour 48: P-value was calculated using Student's t-test|Student's t-test||||
1644567|NCT01814878|3024566|Superiority or Other|||||||0.0404||||||Hour 24: P-value was calculated using Student's t-test|Student's t-test||||
1644568|NCT01814878|3024566|Superiority or Other|||||||0.0485||||||Hour 12: P-value was calculated using Student's t-test|Student's t-test||||
1644569|NCT01814878|3024566|Superiority or Other|||||||0.1498||||||Hour 6: P-value was calculated using Student's t-test|Student's t-test||||
1644570|NCT01814878|3024567|Superiority or Other|||||||0.2209||||||Hour 48: P-value was calculated using Student's t-test|Student's t-test||||
1644571|NCT01814878|3024567|Superiority or Other|||||||0.1147||||||Hour 24: P-value was calculated using Student's t-test|Student's t-test||||
1644572|NCT01814878|3024567|Superiority or Other|||||||0.0714||||||Hour 12: P-value was calculated using Student's t-test|Student's t-test||||
1644573|NCT01814878|3024567|Superiority or Other|||||||0.1542||||||Hour 6: P-value was calculated using Student's t-test|Student's t-test||||
1644574|NCT01814878|3024568|Superiority or Other||Mean Difference (Final Values)|-2.99||||0.0589|2-Sided|95.0|-6.09|0.11||Hour 24: P-value was calculated using Student's t-test|Student's t-test||||
1644575|NCT01814878|3024568|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.172|2-Sided|95.0|-2.68|0.48||Hour 12: P-value was calculated using Student's t-test|Student's t-test||||
1644576|NCT01814878|3024568|Superiority or Other||Mean Difference (Final Values)|-0.32||||0.4082|2-Sided|95.0|-1.1|0.45||Hour 6: P-value was calculated using Student's t-test|Student's t-test||||
1644577|NCT01814878|3024569|Non-Inferiority or Equivalence|Study drug treatment group was considered non-inferior to comparator treatment group, if lower limit of the confidence interval was larger than –2.0|Mean Difference (Final Values)|-4.68||||0.1648|2-Sided|95.0|-11.29|1.93||Hour 48: P-value was calculated using Student's t-test|Student's t-test|||Non-inferiority comparison for Tramadol Hydrochloride/Acetaminophen ER to Tramadol HCl/Acetaminophen IR was performed.|
1644578|NCT01814813|3024600|Superiority|||||||0.56|||||||Chi-squared||||
1644579|NCT01814813|3024601|Superiority||||||<|0.01|||||||Log Rank||||
1644580|NCT01814813|3024602|Superiority|||||||0.16|||||||Log Rank||||
1644581|NCT01814748|3024647|Superiority or Other||Between-group rate difference|4.0|||||2-Sided|95.0|-7.4|15.5|||||||
1644582|NCT01814748|3024648|Superiority or Other||Between-group rate difference|-0.4|||||2-Sided|95.0|-14.0|13.1|||||||
1644583|NCT01814748|3024649|Superiority or Other||Difference in least squares means|-3.7||||0.586|2-Sided|95.0|-17.1|9.7|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|||
1644584|NCT01814748|3024650|Superiority or Other||Difference in least squares means|4.2||||0.685|2-Sided|95.0|-16.1|24.4|||Constrained longitudinal data analysis|Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.|||
1644585|NCT01814748|3024651|Superiority or Other||Difference in percent|-2.0|||||||||||||||
1644586|NCT01814748|3024652|Superiority or Other||Difference in percent|-0.4|||||2-Sided|95.0|-13.8|13.0|||||||
1644594|NCT01814696|3024660|Superiority or Other|||||||0.057|||||||Wilcoxon rank-sum test|||All cause|
1644595|NCT01814696|3024661|Superiority or Other|||||||0.944|||||||Wilcoxon rank-sum test|||Non-heart failure ED visits|
1644596|NCT01814696|3024661|Superiority or Other|||||||0.413|||||||Wilcoxon rank-sum test|||Heart failure related|
1644597|NCT01814696|3024661|Superiority or Other|||||||0.497|||||||Wilcoxon rank-sum test|||All cause|
1644598|NCT01814696|3024662|Superiority or Other|||||||0.042|||||||Fisher Exact||||
1644599|NCT01814696|3024662|Superiority or Other|||||||0.341|||||||Fisher Exact||||
1644600|NCT01814696|3024663|Superiority or Other|||||||0.677|||||||Fisher Exact|||All cause ED visits|
1644601|NCT01814696|3024663|Superiority or Other|||||||1|||||||Fisher Exact|||Non-heart failure related ED visits|
1644602|NCT01814696|3024663|Superiority or Other|||||||0.604|||||||Fisher Exact|||Heart failure related ED visits|
1644603|NCT01814696|3024664|Superiority or Other|||||||0.658||||||a prior threshold p<0.05|Fisher Exact||||
1644604|NCT01814371|3024679|Equivalence|testing equivalence of individualized approach compared to household approach.||||||0.143|||||||Fisher Exact||||
1644605|NCT01814371|3024680|Non-Inferiority|testing non-inferiority of individualized approach compared to household approach.||||||0.381|||||||Fisher Exact||||
1644606|NCT01814371|3024682|Equivalence|testing equivalence of before and after decolonization protocol.||||||0.84|||||||Chi-squared||||
1644607|NCT01814371|3024683|Equivalence|testing equivalence of individualized approach compared to household approach.||||||1|||||||Fisher Exact||||
1644608|NCT01814371|3024684|Non-Inferiority|testing non-inferiority of individualized approach compared to household approach.||||||0.005|||||||Fisher Exact||||
1644609|NCT01814371|3024685|Non-Inferiority|testing non-inferiority of individualized approach compared to household approach.||||||0.007|||||||Fisher Exact||||
1644610|NCT01814371|3024686|Non-Inferiority|testing non-inferiority of individualized approach compared to household approach.||||||0.05|||||||Fisher Exact||||
1644611|NCT01814371|3024687|Non-Inferiority|testing non-inferiority of individualized approach compared to household approach.||||||0.006|||||||Fisher Exact||||
1644612|NCT01814371|3024688|Non-Inferiority|testing non-inferiority of individualized approach compared to household approach.||||||0.004|||||||Fisher Exact||||
1644613|NCT01814371|3024689|Non-Inferiority|testing non-inferiority of individualized approach compared to household approach.||||||0.811|||||||Fisher Exact||||
1644614|NCT01814371|3024690|Non-Inferiority|testing non-inferiority of individualized approach compared to household approach.||||||1|||||||Fisher Exact||||
1644615|NCT01814371|3024691|Non-Inferiority|testing non-inferiority of individualized approach compared to household approach.||||||0.687|||||||Fisher Exact||||
1644616|NCT01814371|3024692|Non-Inferiority|testing non-inferiority of individualized approach compared to household approach.||||||1|||||||Fisher Exact||||
1644617|NCT01814371|3024693|Non-Inferiority|testing non-inferiority of individualized approach compared to household approach.||||||0.757|||||||Fisher Exact||||
1644618|NCT01813890|3024718|Superiority or Other||Median Difference (Net)|126.58||||0.004|2-Sided|95.0|49.5|203.7||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.|Based on participant availability in Taiwan it was expected that 60 subjects (20 per group) would be enrolled. In consultation with the Taiwan health authority, the overall two-sided significance level was set at 0.20 (0.10 for each tapentadol versus placebo comparison). Assuming a standard deviation of 134.4, this sample size would provide 71.5% power to detect a between-group difference in SPID48 of 94.1 and 81.2% power to detect a between-group difference of 107.52.|
1644619|NCT01813890|3024718|Superiority or Other||Mean Difference (Net)|105.61||||0.006|2-Sided|95.0|32.0|179.2||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group|Based on participant availability in Taiwan it was expected that 60 subjects (20 per group) would be enrolled. In consultation with the Taiwan health authority, the overall two-sided significance level was set at 0.20 (0.10 for each tapentadol versus placebo comparison). Assuming a standard deviation of 134.4, this sample size would provide 71.5% power to detect a between-group difference in SPID48 of 94.1 and 81.2% power to detect a between-group difference of 107.52.|
1644620|NCT01813422|3024764|Superiority or Other||Treatment Difference|12.5||||0.0002|2-Sided|95.0|5.8|19.1|||Cochran-Mantel-Haenszel|Based on CMH test stratified by geographic region.|Treatment difference uses placebo as the reference.||
1644621|NCT01813422|3024765|Superiority or Other||Treatment Difference|17.0|||<|0.0001|2-Sided|95.0|10.3|23.5|||Cochran-Mantel-Haenszel|Based on CMH test stratified by geographic region.|Treatment difference uses placebo as the reference.||
1644622|NCT01813422|3024766|Superiority or Other||LS Mean Treatment Difference|-4.889|Standard Error of the Mean|1.201|<|0.0001|2-Sided|95.0|-7.247|-2.531|||ANCOVA|ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline TAV.|Treatment difference uses placebo as the reference.||
1644623|NCT01813422|3024767|Superiority or Other||LS Mean Treatment Difference|-1.007|Standard Error of the Mean|0.187|<|0.0001|2-Sided|95.0|-1.375|-0.64|||ANCOVA|ANCOVA model included terms for the treatment group, the geographic region stratification factor, and baseline PAV.|Treatment difference uses placebo as the reference.||
1644624|NCT01813058|3024833|Superiority||Mean Difference (Final Values)|195.0|||<|0.001|2-Sided||||||Fisher Exact||||
1644625|NCT01813019|3024835|Superiority or Other|||||||0.671|||||||Mixed Models Analysis||||
1644626|NCT01812707|3024843|Superiority or Other||||||<|0.0001||||||Threshold for significance ≤0.05|ANCOVA||||
1644627|NCT01812707|3024843|Superiority or Other||||||<|0.0001||||||Threshold for significance ≤0.05|ANCOVA||||
1644628|NCT01812707|3024843|Superiority or Other||||||<|0.0001||||||Threshold for significance ≤0.05|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~Alirocumab 150 mg Q2W versus placebo~Alirocumab 75 mg Q2W versus placebo~Alirocumab 50 mg Q2W versus placebo~Testing continued only when high-order test was statistically significant at 5% level."|
1644743|NCT01809262|3025053|Superiority or Other||Mean Difference (Final Values)|0.455|Standard Error of the Mean|0.049|<|0.0001||95.0|0.359|0.551|||ANCOVA||||
1644629|NCT01812655|3024846|Superiority or Other||Semipartial correlation|-0.217||||0.045||95.0|||||Semipartial correlation||Semipartial correlation between Belief in Distraction's Efficacy and Procedural Pain (Outcome Measure #1) for all participants||
1644630|NCT01812655|3024846|Superiority or Other||Semipartial Correlation|-0.622||||0.007||95.0|||||Semipartial Correlation||Semipartial correlation between Belief in Distraction's Efficacy and STAIC Trait Anxiety measured at Baseline for all participants||
1644631|NCT01812655|3024846|Superiority or Other||Semipartial Correlation|-0.102||||0.61||95.0|||||Semipartial Correlation||Semipartial correlation between Belief in Distraction's Efficacy and STAIC State Anxiety measured at Baseline for all participants||
1644632|NCT01812655|3024846|Superiority or Other||Semipartial correlation|0.21||||0.054||95.0|||||Semipartial correlation||Semipartial correlation between Engagement with Distraction and Procedural Pain (Outcome Measure #1) for all participants||
1644633|NCT01812655|3024846|Superiority or Other||Semipartial correlation|-0.347||||0.18||95.0|||||Semipartial correlation||Semipartial correlation between Engagement with Distraction and STAIC Trait Anxiety measured at Baseline for all participants||
1644634|NCT01812655|3024846|Superiority or Other||semipartial correlation|-0.276||||0.15||95.0|||||Semipartial Correlation||Semipartial correlation between Engagement with Distraction and STAIC State Anxiety measured at Baseline for all participants||
1644635|NCT01812655|3024847|Superiority or Other||Semipartial correlation|-0.059||||0.6||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and Procedural Pain (Outcome Measure #1) for all participants||
1644636|NCT01812655|3024847|Superiority or Other||Semipartial correlation|0.119||||0.59||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and STAIC Trait Anxiety measured at Baseline for all participants||
1644637|NCT01812655|3024847|Superiority or Other||Semipartial correlation|0.223||||0.26||95.0|||||Semipartial correlation||Semipartial correlation between desire for distraction and STAIC State Anxiety measured at Baseline for all participants||
1644638|NCT01812655|3024848|Superiority or Other||Mean Difference (Final Values)|9.7||||0.32|2-Sided|95.0|-9.5|28.9|||Regression, Linear||Mean difference = VR group - SC group||
1644639|NCT01812655|3024848|Superiority or Other||Mean Difference (Final Values)|23.7||||0.029|2-Sided|95.0|2.4|45.0|||Regression, Linear||Mean difference = PD group - VR group||
1644640|NCT01812057|3024852|Superiority|||||||0.188|||||||Chi-squared||||
1644641|NCT01812057|3024852|Superiority|||||||1|||||||Fisher Exact||||
1644642|NCT01812057|3024852|Superiority|||||||0.028|||||||Chi-squared|Postoperative need for rescue antiemetic|||
1644643|NCT01812057|3024852|Superiority|||||||0.302|||||||Chi-squared|Incidence of PONV at 24 h|||
1644644|NCT01812057|3024853|Superiority|||||||0.7|||||||Fisher Exact||||
1644645|NCT01812057|3024854|Superiority|||||||0.924|||||||Chi-squared|Incidence of postoperative pruritus|||
1644646|NCT01812057|3024856|Superiority|||||||1|||||||Fisher Exact||||
1644647|NCT01812057|3024856|Superiority|||||||0.676|||||||Chi-squared|Need for intraoperative antiemetics|||
1644648|NCT01812057|3024856|Superiority|Intraoperative nausea and vomiting||||||0.245|||||||Fisher Exact||||
1644649|NCT01812057|3024857|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)|||Pain scores on movement at 24h|We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminated the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores on movement.
1644650|NCT01812057|3024857|Superiority|||||||0.805|||||||Wilcoxon (Mann-Whitney)|||24 hour pain scores at rest between MTS groups|We also performed a multivariable regression analysis to determine factors associated with Pain scores at rest at 24 hours accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factors with the largest p-value over 0.05. MTS category was not included in the final model for 24 h pain scores at rest.
1644651|NCT01812057|3024858|Superiority|||||||0.322|||||||Fisher Exact||||
1644652|NCT01812057|3024859|Superiority|||||||0.42|||||||Fisher Exact|Chronic pain at 8 weeks|||
1644653|NCT01812057|3024860|Superiority|||||||0.355|||||||Wilcoxon (Mann-Whitney)|Total opioid consumption at 24 hours|||We also performed a multivariable regression analysis to determine factors associated with 24h opioid consumption accounting for MTS category, demographic factors, study group allocation (dexamethasone vs placebo) and a preoperative questions to assess patients anxiety, anticipated pain scores after surgery and anticipated analgesic need after surgery. At each step of backward variable selection, we eliminate the factor with the largest p-value over 0.05.In the final model MTS was not associated with 24h opioid consumption parameter estimate (standard error) = 9.15 (5.27), p=0.09.
1644654|NCT01812057|3024861|Superiority|Pain Scores with movement at 48 hours||||||0.525|||||||Wilcoxon (Mann-Whitney)||||
1644655|NCT01812057|3024861|Superiority|Pain Score at rest at 48 hours||||||0.491|||||||Wilcoxon (Mann-Whitney)||||
1644656|NCT01812057|3024862|Superiority|Pain Score with movement at 24 hours||||||0.518|||||||t-test, 2 sided||||
1644657|NCT01812057|3024862|Superiority|Pain Score at rest at 24 hours||||||0.267|||||||Wilcoxon (Mann-Whitney)||||
1644658|NCT01812057|3024863|Superiority|||||||0.709|||||||Wilcoxon (Mann-Whitney)||||
1644659|NCT01812057|3024864|Superiority|||||||0.1965|||||||Log Rank||||
1644660|NCT01812057|3024865|Superiority|Pain Score with movement at 2 hours||||||0.204|||||||t-test, 2 sided||||
1644661|NCT01812057|3024865|Superiority|Pain Score at rest at 2 hours||||||0.171|||||||t-test, 2 sided||||
1644662|NCT01812057|3024866|Superiority|||||||0.74|||||||Wilcoxon (Mann-Whitney)||||
1644663|NCT01812044|3024873|Superiority or Other|||||||0.298|||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.|||
1644664|NCT01812044|3024873|Superiority or Other|||||||0.189|||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.|||
1644665|NCT01812044|3024873|Superiority or Other|||||||0.035|||||||Wilcoxon (Mann-Whitney)|P-value based on Wilcoxon rank sum test of difference in medians between groups.|||
1644666|NCT01811953|3024884|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|100.74|Standard Error of the Mean|1.03|<|0.0001|2-Sided|90.0|95.77|105.96|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.||
1644667|NCT01811953|3024884|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|99.31|Standard Error of the Mean|1.04|<|0.0001|2-Sided|90.0|92.14|107.03|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.||
1644668|NCT01811953|3024884|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|94.89|Standard Error of the Mean|1.03|<|0.0001|2-Sided|90.0|89.8|100.26|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.||
1644669|NCT01811953|3024885|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.95|Standard Error of the Mean|1.034|<|0.0001|2-Sided|90.0|97.166|109.082|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.||
1644670|NCT01811953|3024885|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|97.97|Standard Error of the Mean|1.035|<|0.0001|2-Sided|90.0|92.339|103.935|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.||
1644671|NCT01811953|3024885|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|94.87|Standard Error of the Mean|1.038|<|0.0001|2-Sided|90.0|88.931|101.21|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.||
1644672|NCT01811953|3024886|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|104.352|Standard Error of the Mean|1.031|<|0.0001|2-Sided|90.0|99.152|110.224|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.||
1644673|NCT01811953|3024886|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|106.52|Standard Error of the Mean|1.063|<|0.0082|2-Sided|90.0|95.863|118.353|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.||
1644674|NCT01811953|3024886|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.12|Standard Error of the Mean|1.035|<|0.0001|2-Sided|90.0|96.255|108.351|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.||
1644675|NCT01811953|3024887|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|105.98|Standard Error of the Mean|1.018|<|0.0001|2-Sided|90.0|102.73|109.329|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.||
1644676|NCT01811953|3024887|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|98.82|Standard Error of the Mean|1.024|<|0.0001|2-Sided|90.0|94.784|103.037|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.||
1644677|NCT01811953|3024887|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.33|Standard Error of the Mean|1.017|<|0.0001|2-Sided|90.0|99.315|105.43|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.||
1644678|NCT01811953|3024888|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean difference|100.81|Standard Error of the Mean|1.03|<|0.0001|2-Sided|90.0|95.74|106.14|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.||
1644708|NCT01811238|3024944|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Deviation|0.37|<|0.05|2-Sided|95.0|0.0|1.12|||t-test, 2 sided|The change(difference) in EQ-5D score at Week 8 from baseline was analyzed by using paired t-test.|||
1644679|NCT01811953|3024888|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|99.34|Standard Error of the Mean|1.04|<|0.0001|2-Sided|90.0|92.56|106.62|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.||
1644680|NCT01811953|3024888|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|96.13|Standard Error of the Mean|1.03|<|0.0001|2-Sided|90.0|91.25|101.26|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.||
1644681|NCT01811953|3024889|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|106.0|Standard Error of the Mean|1.018|<|0.0001|2-Sided|90.0|102.728|109.386|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '5 Empagliflozin/Metformin (T)' divided by the geometric mean of '6 Empagliflozin + Metformin (R)'.||
1644682|NCT01811953|3024889|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|98.88|Standard Error of the Mean|1.024|<|0.0001|2-Sided|90.0|94.879|103.059|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '2 Empagliflozin/Metformin (T)' divided by the geometric mean of '4 Empagliflozin + Metformin (R)'.||
1644683|NCT01811953|3024889|Non-Inferiority or Equivalence|The assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMean), test/reference, for the primary endpoints using an acceptance range of 80.00 to 125.00%.|Geometric mean ratio|102.55|Standard Error of the Mean|1.017|<|0.0001|2-Sided|90.0|99.531|105.653|||ANOVA||The geometric mean ratio was calculated as the geometric mean of '1 Empagliflozin/Metformin (T)' divided by the geometric mean of '3 Empagliflozin + Metformin (R)'.||
1644684|NCT01811732|3024894|Non-Inferiority|A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in sample rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.|Difference in Responder Rates|-2.6|||||2-Sided|95.0|-8.8|3.6|||||||
1644685|NCT01811706|3024895|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of Stride Length on BAG between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).|
1644686|NCT01811706|3024896|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of SARA score between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).|
1644687|NCT01811706|3024897|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Null hypothesis is that there was no difference in change of T25FW between Dalfampridine and Placebo. The test was performed with a significant level of 0.05 (two-sided).|
1644688|NCT01811563|3024905|Equivalence|Between implants at 6 weeks||||||0.319|||||||t-test, 2 sided||||
1644689|NCT01811563|3024906|Equivalence|Interaction between implant and time, baseline to 52 weeks||||||0.728|||||||ANOVA||||
1644690|NCT01811563|3024906|Equivalence|Main effect by time, baseline to 52 weeks|||||<|0.001|||||||ANOVA||||
1644691|NCT01811563|3024906|Equivalence|Main effect by implant, Baseline to 52 weeks|||||<|0.83|||||||ANOVA||||
1644692|NCT01811563|3024908|Equivalence|Implant by time interaction, baseline to 52 weeks||||||0.917|||||||ANOVA||||
1644693|NCT01811563|3024908|Equivalence|Main effect for time, Baseline to 52 weeks|||||<|0.001|||||||ANOVA||||
1644694|NCT01811563|3024908|Equivalence|Main effect for implant, baseline to 52 weeks|||||<|0.416|||||||ANOVA||||
1644695|NCT01811563|3024910|Equivalence|Interaction of time by implant, Baseline to 52 weeks||||||0.365|||||||ANOVA||||
1644696|NCT01811563|3024910|Equivalence|Main effect for time, Baseline to 52 weeks|||||<|0.001|||||||ANOVA||||
1644697|NCT01811563|3024910|Equivalence|Main effect for implant, Baseline to 52 weeks|||||<|0.158|||||||ANOVA||||
1644698|NCT01811563|3024911|Equivalence|Implant by Time interaction, Baseline to 52 Weeks between Zimmer and Stryker||||||0.822|||||||ANOVA||||
1644699|NCT01811563|3024911|Equivalence|Time independent of implant, Baseline to 52 Weeks|||||<|0.001|||||||ANOVA||||
1644700|NCT01811563|3024911|Equivalence|Main effect for implant independent of time|||||<|0.856|||||||ANOVA|Main effect for implant, LQ-YBT Baseline to 52 weeks|||
1644701|NCT01811563|3024912|Equivalence|Interaction between implant and time||||||0.27|||||||ANOVA||||
1644702|NCT01811563|3024912|Equivalence|Main effect for time independent of implant|||||<|0.001|||||||ANOVA||||
1644703|NCT01811563|3024912|Equivalence|Main effect for implant independent of time|||||<|0.661|||||||ANOVA||||
1644704|NCT01811472|3024930|Non-Inferiority or Equivalence|The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of −5.2% for pradigastat vs placebo for the primary endpoint.|Mean Difference (Net)|-2.89||||0.0457|2-Sided|90.0|-5.25|-0.53|||Mixed Model of Repeated Measurements|Degrees of freedom are adjusted using the Kenward-Roger method.||Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 10mg/20mg was different from placebo.|
1644705|NCT01811472|3024930|Non-Inferiority or Equivalence|The power calculation was largely driven by the maximum true response assumed in the candidate response shapes, which is a difference of −5.2% for pradigastat vs placebo for the primary endpoint.|Mean Difference (Net)|-1.69||||0.3128|2-Sided|90.0|-4.46|1.09|||Mixed Model of Repeated Measurements|Degrees of freedom are adjusted using the Kenward-Roger method.||Hypothesis was tested at the 1-sided 5% significance level to assess if LCQ908 5mg/10mg was different from placebo.|
1644706|NCT01811303|3024939|Superiority or Other||||||<|0.016|||||||ANOVA||||
1644707|NCT01811303|3024939|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1644709|NCT01811238|3024945|Superiority or Other||Mean Difference (Final Values)|-1.69|Standard Deviation|2.18|<|0.05|2-Sided|95.0|||||t-test, 2 sided|"The primary endpoint will be the actual reduction rate of pain intensity (0 -10) score at 8 weeks.~It will be analyzed by using paired t-test."|||
1644710|NCT01810952|3024964|Superiority or Other|||||||0.055||||||Comparison between groups of percent of glucose values >180 mg/dL.|Chi-squared|||Values in each group were compared by Chi squared.|
1644711|NCT01810952|3024965|Superiority or Other|||||||0.795||||||Comparison of the number of participants in each group with glucose value <70 mg/dL resulted in p-value 0.795.|Chi-squared||||
1644712|NCT01810952|3024966|Superiority or Other|||||||0.06||||||Comparison of the 5 day averages resulted in a p-value of 0.06.|t-test, 2 sided|||Daily values for each protocol were compared using t-tests.|
1644713|NCT01810952|3024967|Superiority or Other|||||||0.65|||||||Chi-squared||||
1644714|NCT01810952|3024968|Superiority or Other|||||||0.35||||||This is the p-value for Day 5|t-test, 2 sided||||
1644715|NCT01810939|3024969|Superiority or Other||||||<|0.001|||||||ANCOVA|||Test for difference between treatment groups in serum potassium change in Part B|
1644716|NCT01810939|3024970|Superiority or Other||||||<|0.001|||||||Longitudinal mixed models|Test that the mean change is significantly different from zero.||Estimation of mean change in serum potassium from Part A Baseline to Part A Week 4 and test mean change different from zero.|
1644717|NCT01810939|3024971|Superiority or Other||||||<|0.001|||||||Mantel Haenszel|||Test for difference between treatment groups in proportion with serum potassium ≥ 5.1 mEq/L|
1644718|NCT01810939|3024972|Superiority or Other||||||<|0.001|||||||Mantel Haenszel|||Test for difference between treatment groups in proportion with serum potassium ≥ 5.5 mEq/L|
1644719|NCT01810939|3024973|Superiority or Other||Proportion|0.76|||||2-Sided|95.0|0.7|0.81|||||||
1644720|NCT01810380|3025002|Superiority or Other||Least square mean difference|-8.0|Standard Error of the Mean|2.1||0.0002|2-Sided|95.0|-12.2|-3.9|||Mixed Models Analysis||||
1644721|NCT01810380|3025002|Superiority or Other||Least square mean difference|-4.1|Standard Error of the Mean|2.1||0.056|2-Sided|95.0|-8.2|0.1||For all efficacy analyses the primary comparison is the difference between brexpiprazole 2 to 4 mg/day and placebo at Week 6.|Mixed Models Analysis|Pooled site, visit, treatment as fixed effects, baseline score as continuous covariate, treatment-by-visit and baseline score-by-visit as interactions||The overall significance level was 0.05. The primary and the key secondary endpoints were tested hierarchically. Only if the primary endpoint was statistically significant would confirmatory testing continue with the key secondary endpoint.|
1644722|NCT01809639|3025037|Superiority or Other|||||||0.42|||||||ANOVA||||
1644723|NCT01809327|3025039|Superiority or Other||Hodges-Lehman Estimate|1.3||||0.806|2-Sided|95.0|-7.3|10.0|||Wilcoxon (Mann-Whitney)||||
1644724|NCT01809327|3025039|Superiority or Other||Hodges-Lehman Estimate|-3.7||||0.608|2-Sided|95.0|-11.1|3.4|||Wilcoxon (Mann-Whitney)||||
1644725|NCT01809327|3025040|Superiority or Other||Least-Squares Mean Difference|4.3|Standard Error of the Mean|2.1||0.147|2-Sided|95.0|0.2|8.5|||ANCOVA||||
1644726|NCT01809327|3025040|Superiority or Other||Least-Squares Mean Difference|5.3|Standard Error of the Mean|2.1||0.147|2-Sided|95.0|1.2|9.5|||ANCOVA||||
1644727|NCT01809327|3025041|Superiority or Other||Least-Squares Mean Difference|-1.31|Standard Error of the Mean|0.889||0.147|2-Sided|95.0|-3.058|0.431|||Mixed Model for Repeated Measures (MMRM)||||
1644728|NCT01809327|3025041|Superiority or Other||Least-Squares Mean Difference|-1.91|Standard Error of the Mean|0.882||0.06|2-Sided|95.0|-3.641|-0.182|||Mixed Model for Repeated Measures (MMRM)||||
1644729|NCT01809327|3025042|Superiority or Other||Odds Ratio (OR)|2.21||||0.016|2-Sided|95.0|1.46|3.33|||Generalized Linear Mixed Model||||
1644730|NCT01809327|3025042|Superiority or Other||Odds Ratio (OR)|1.58||||0.027|2-Sided|95.0|1.06|2.37|||Generalized Linear Mixed Model||||
1644731|NCT01809327|3025043|Superiority or Other||Least-Squares Mean Difference|-2.1|Standard Error of the Mean|0.4||0.001|2-Sided|95.0|-2.9|-1.4|||Mixed Model for Repeated Measures (MMRM)||||
1644732|NCT01809327|3025043|Superiority or Other||Least-Squares Mean Difference|-1.4|Standard Error of the Mean|0.4||0.001|2-Sided|95.0|-2.1|-0.6|||Mixed Model for Repeated Measures (MMRM)||||
1644733|NCT01809327|3025043|Superiority or Other||Least-Squares Mean Difference|-1.8|Standard Error of the Mean|0.4||0.002|2-Sided|95.0|-2.6|-1.1|||Mixed Model for Repeated Measures (MMRM)||||
1644734|NCT01809327|3025043|Superiority or Other||Least-Squares Mean Difference|-0.9|Standard Error of the Mean|0.4||0.016|2-Sided|95.0|-1.6|-0.2|||Mixed Model for Repeated Measures (MMRM)||||
1644735|NCT01809327|3025044|Non-Inferiority or Equivalence|P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%.|Least-Squares Mean Difference|-0.11|Standard Error of the Mean|0.099||0.001|2-Sided|95.0|-0.307|0.082|||Mixed Model for Repeated Measures (MMRM)||||
1644736|NCT01809327|3025044|Non-Inferiority or Equivalence|P value corresponds to a comparison that canagliflozin is noninferior to Metformin XR by a margin of 0.35%.|Least-Squares Mean Difference|-0.06|Standard Error of the Mean|0.1||0.001|2-Sided|95.0|-0.258|0.133|||Mixed Model for Repeated Measures (MMRM)||||
1644737|NCT01809327|3025044|Superiority or Other||Least-Squares Mean Difference|-0.36|Standard Error of the Mean|0.099||0.001|2-Sided|95.0|-0.557|-0.169|||Mixed Model for Repeated Measures (MMRM)||||
1644738|NCT01809327|3025044|Superiority or Other||Least-Squares Mean Difference|-0.4|Standard Error of the Mean|0.099||0.001|2-Sided|95.0|-0.594|-0.207|||Mixed Model for Repeated Measures (MMRM)||||
1644739|NCT01809327|3025044|Superiority or Other||Least-Squares Mean Difference|-0.48|Standard Error of the Mean|0.099||0.001|2-Sided|95.0|-0.67|-0.28|||Mixed Model for Repeated Measures (MMRM)||||
1644740|NCT01809327|3025044|Superiority or Other||Least-Squares Mean Difference|-0.46|Standard Error of the Mean|0.099||0.001|2-Sided|95.0|-0.657|-0.269|||Mixed Model for Repeated Measures (MMRM)||||
1644741|NCT01809314|3025046|Superiority or Other|||||||0.001|||||||Wilcoxon signed-rank test|||Overall (all categories combined) change from Baseline in ECOG performance status at Month 4 was analyzed using Wilcoxon signed-rank test.|
1644742|NCT01809314|3025047|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed-rank test|||The difference between Baseline and Month 4 was analyzed using the Wilcoxon signed-rank test.|
1644744|NCT01809262|3025053|Superiority or Other||Mean Difference (Final Values)|0.35|Standard Error of the Mean|0.049|<|0.0001||95.0|0.253|0.447|||ANCOVA||||
1644745|NCT01809262|3025053|Superiority or Other||Mean Difference (Final Values)|0.355|Standard Error of the Mean|0.049|<|0.0001||95.0|0.258|0.452|||ANCOVA||||
1644746|NCT01809262|3025053|Superiority or Other||Mean Difference (Final Values)|0.306|Standard Error of the Mean|0.049|<|0.0001||95.0|0.21|0.402|||ANCOVA||||
1644747|NCT01809262|3025054|Superiority or Other||Mean Difference (Final Values)|0.213|Standard Error of the Mean|0.019|<|0.0001||95.0|0.176|0.25|||ANCOVA||||
1644748|NCT01809262|3025054|Superiority or Other||Mean Difference (Final Values)|0.176|Standard Error of the Mean|0.019|<|0.0001||95.0|0.139|0.214|||ANCOVA||||
1644749|NCT01809262|3025054|Superiority or Other||Mean Difference (Final Values)|0.166|Standard Error of the Mean|0.019|<|0.0001||95.0|0.129|0.203|||ANCOVA||||
1644750|NCT01809262|3025054|Superiority or Other||Mean Difference (Final Values)|0.121|Standard Error of the Mean|0.019|<|0.0001||95.0|0.084|0.158|||ANCOVA||||
1644751|NCT01809262|3025055|Superiority or Other||Mean Difference (Final Values)|0.141|Standard Error of the Mean|0.017|<|0.0001||95.0|0.107|0.174|||ANCOVA||||
1644752|NCT01809262|3025055|Superiority or Other||Mean Difference (Final Values)|0.122|Standard Error of the Mean|0.017|<|0.0001||95.0|0.089|0.156|||ANCOVA||||
1644753|NCT01809262|3025055|Superiority or Other||Mean Difference (Final Values)|0.096|Standard Error of the Mean|0.017|<|0.0001||95.0|0.062|0.13|||ANCOVA||||
1644754|NCT01809262|3025055|Superiority or Other||Mean Difference (Final Values)|0.074|Standard Error of the Mean|0.017|<|0.0001||95.0|0.041|0.108|||ANCOVA||||
1644755|NCT01809262|3025056|Superiority or Other||Mean Difference (Final Values)|0.162|Standard Error of the Mean|0.015|<|0.0001||95.0|0.132|0.193|||ANCOVA||||
1644756|NCT01809262|3025056|Superiority or Other||Mean Difference (Final Values)|0.138|Standard Error of the Mean|0.015|<|0.0001||95.0|0.107|0.168|||ANCOVA||||
1644757|NCT01809262|3025056|Superiority or Other||Mean Difference (Final Values)|0.118|Standard Error of the Mean|0.015|<|0.0001||95.0|0.087|0.148|||ANCOVA||||
1644758|NCT01809262|3025056|Superiority or Other||Mean Difference (Final Values)|0.087|Standard Error of the Mean|0.015|<|0.0001||95.0|0.056|0.117|||ANCOVA||||
1644759|NCT01809262|3025057|Superiority or Other||Mean Difference (Final Values)|0.184|Standard Error of the Mean|0.016|<|0.0001||95.0|0.152|0.215|||ANCOVA||||
1644760|NCT01809262|3025057|Superiority or Other||Mean Difference (Final Values)|0.153|Standard Error of the Mean|0.016|<|0.0001||95.0|0.122|0.185|||ANCOVA||||
1644761|NCT01809262|3025057|Superiority or Other||Mean Difference (Final Values)|0.139|Standard Error of the Mean|0.016|<|0.0001||95.0|0.107|0.171|||ANCOVA||||
1644762|NCT01809262|3025057|Superiority or Other||Mean Difference (Final Values)|0.099|Standard Error of the Mean|0.016|<|0.0001||95.0|0.068|0.131|||ANCOVA||||
1644763|NCT01809262|3025058|Superiority or Other||Mean Difference (Final Values)|0.192|Standard Error of the Mean|0.016|<|0.0001||95.0|0.161|0.223|||ANCOVA||||
1644764|NCT01809262|3025058|Superiority or Other||Mean Difference (Final Values)|0.161|Standard Error of the Mean|0.016|<|0.0001||95.0|0.13|0.192|||ANCOVA||||
1644765|NCT01809262|3025058|Superiority or Other||Mean Difference (Final Values)|0.155|Standard Error of the Mean|0.016|<|0.0001||95.0|0.124|0.186|||ANCOVA||||
1644766|NCT01809262|3025058|Superiority or Other||Mean Difference (Final Values)|0.108|Standard Error of the Mean|0.016|<|0.0001||95.0|0.077|0.139|||ANCOVA||||
1644767|NCT01809262|3025059|Superiority or Other||Mean Difference (Final Values)|0.119|Standard Error of the Mean|0.02|<|0.0001||95.0|0.08|0.158|||ANCOVA||||
1644768|NCT01809262|3025059|Superiority or Other||Mean Difference (Final Values)|0.113|Standard Error of the Mean|0.02|<|0.0001||95.0|0.074|0.152|||ANCOVA||||
1644769|NCT01809262|3025059|Superiority or Other||Mean Difference (Final Values)|0.099|Standard Error of the Mean|0.02|<|0.0001||95.0|0.06|0.138|||ANCOVA||||
1644770|NCT01809262|3025059|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.02|<|0.0005||95.0|0.031|0.109|||ANCOVA||||
1644771|NCT01808690|3025084|Superiority|||||||0.8||||||Threshold for significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in systolic blood pressure, change in BMI, and change in M/I.|||
1644772|NCT01808690|3025085|Superiority|||||||0.03||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in SBP, change in BMI, and change in M/I.|||
1644773|NCT01808690|3025087|Superiority|||||||0.04||||||Threshold for significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in systolic blood pressure, change in BMI, and change in M/I.|||
1644774|NCT01808690|3025088|Superiority|||||||0.04||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted mutlivariable models, which included changed in SBP, change in BMI, and change in M/I.|||
1644775|NCT01808690|3025089|Superiority|||||||0.46||||||Threshold for statistical significance P=0.05|Regression, Linear|Adjusted for the baseline value of the variable, sex, age, change in VO2peak, change in insulin sensitivity, and treatment condition.|||
1644776|NCT01808690|3025090|Superiority|||||||0.005||||||Threshold for statistical significance P=0.05|Regression, Linear|We also fitted multivariable models, which included sex, pubertal status, change in BMI, and baseline M/I.||Insulin function was defined as M/I (mg/kg/min)/(insulin). Power calculations were based on data from a small study in youth with poorly controlled T1DM, which reported a significant increase in M/I in the 11 participants treated with Metformin. On the basis of the effect size reported in that study, a sample size of 25 per group and an alpha of 0.05 provided us with 93% power to detect a difference of 1 SD in the primary outcome of M/I.|
1644777|NCT01808612|3025105|Superiority or Other||LS Mean Difference|0.73||||0.264|2-Sided|95.0|-0.55|2.0|||Mixed Models Analysis|||Approximately 522 participants were to be enrolled. Randomization was to be 2:1:3 (20 mg fluoxetine:40 mg fluoxetine:placebo). Assuming 5% of participants would have missing post-baseline data, the study had 85% power to detect an effect size of 0.33 (20 mg fluoxetine compared to placebo on HAMD21 total score) based on simulations with a 0.05 two-sided significance level.|
1644778|NCT01808573|3025107|Superiority||Hazard Ratio (HR)|0.495||||0.0004|2-Sided|95.0|0.332|0.736|||Log Rank||Lapatinib Plus Capecitabine is the reference.||
1644779|NCT01808573|3025108|Superiority|||||||0.0328|||||||Cochran-Mantel-Haenszel|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral.|||
1644894|NCT01806857|3025465|Superiority or Other|||||||0.0001|||||||Random Effects Model||||
1644780|NCT01808573|3025109|Superiority|||||||0.1201|||||||Cochran-Mantel-Haenszel|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral.|||
1644781|NCT01808573|3025110|Superiority|||||||0.043|||||||Gray's test|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral disease.|||
1644782|NCT01808573|3025111|Superiority||Hazard Ratio (HR)|0.881||||0.2086|2-Sided|95.0|0.723|1.073|||Log Rank|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|Lapatinib plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.||
1644783|NCT01808573|3025112|Superiority||Hazard Ratio (HR)|0.762||||0.0059|2-Sided|95.0|0.626|0.926|||Log Rank|Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.|Lapatinib Plus Capecitabine is the reference. Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting, and visceral disease vs. non-visceral.||
1644784|NCT01808339|3025132|Superiority or Other||Median Difference (Final Values)|-0.028|||||2-Sided|90.0|-0.102|0.045|||||The estimated value represents the difference in Least Squares Means between FF 100 µg AM and FF 100 µg PM (FF 100 µg AM minus FF 100 µg PM).||
1644785|NCT01808339|3025132|Superiority or Other||Median Difference (Final Values)|0.105|||||2-Sided|90.0|0.029|0.18|||||The estimated value represents the difference in Least Squares Means between FF 100 µg PM and Placebo (FF 100 µg PM minus Placebo).||
1644786|NCT01808339|3025132|Superiority or Other||Median Difference (Final Values)|0.077|||||2-Sided|90.0|0.001|0.152|||||The estimated value represents the difference in Least Squares Means between FF 100 µg AM and Placebo (FF 100 µg AM minus Placebo).||
1644787|NCT01808313|3025177|Superiority or Other||Mean Difference (Final Values)|0.37|||<|0.001|2-Sided|95.0|0.303|0.453|||Wilcoxon signed-rank test||Week 24||
1644788|NCT01808313|3025177|Superiority or Other||Mean Difference (Net)|0.44|||<|0.001|2-Sided|95.0|0.366|0.519|||Wilcoxon signed-rank test||Week 12||
1644789|NCT01808313|3025178|Superiority or Other|||||||0.003|||||||Wilcoxon signed-rank test|||Week 24|
1644790|NCT01808313|3025178|Superiority or Other||||||<|0.001|||||||Wilcoxon signed-rank test|||Week 12|
1644791|NCT01808313|3025180|Superiority or Other||Mean Difference (Final Values)|64.36|||<|0.001|2-Sided|95.0|48.72|80.0|||t-test, 2 sided||||
1644792|NCT01808313|3025181|Superiority or Other||Mean Difference (Final Values)|53.59|||<|0.001|2-Sided|95.0|42.53|64.66|||t-test, 2 sided||||
1644793|NCT01808261|3025206|Other||Mean Difference (Net)|3.944|Standard Error of the Mean|3.5635|||2-Sided|95.0|-3.15|11.037||||||Statistical data for Day 180. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.|
1644794|NCT01808261|3025206|Other||Mean Difference (Net)|2.435|Standard Error of the Mean|3.5633|||2-Sided|95.0|-4.668|9.538||||||Statistical data for Day 90. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.|
1644795|NCT01808261|3025206|Other||Mean Difference (Net)|3.015|Standard Error of the Mean|2.8732|||2-Sided|95.0|-2.704|8.735||||||Statistical data for Day 60. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.|
1644796|NCT01808261|3025206|Other||Mean Difference (Net)|2.408|Standard Error of the Mean|2.7495|||2-Sided|95.0|-3.067|7.883||||||Statistical data for Day 30. The point estimate and confidence interval are for the adjusted mean difference based on least square estimates.|
1644797|NCT01808261|3025208|Other||Mean Difference (Net)|0.0794|Standard Error of the Mean|0.0857||0.828|2-Sided|95.0|-0.093|0.247||P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg – placebo) is greater than 0 m/s at Month 6/Day 180.|Bayesian method|||Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.|
1644798|NCT01808261|3025209|Other||Mean Difference (Net)|0.0443|Standard Error of the Mean|0.0809||0.713||95.0|-0.119|0.2||P-value presented is the posterior probability that the treatment difference (GSK249320 15mg/kg – placebo) is greater than 0 m/s at Month 3/Day 90.|Bayesian method|||Credible intervals are displayed as confidence intervals. Posterior means, standard deviations, and credible intervals are provided in the table.|
1644799|NCT01808118|3025246|Other||||||<|0.001|||||||Log Rank|||The statistical test was performed at a 2-sided significance level of 0.05. Time to flare analysis showed statistically significant lower risk of flare in the adalimumab group than in the placebo group.|
1644800|NCT01808118|3025265|Other||||||<|0.001||||||2-sided Pearson's chi-square test|Chi-squared||||
1644801|NCT01808092|3025313|Non-Inferiority or Equivalence|The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.|percentage: units for RD are %|-0.7|||<|0.001|2-Sided|95.0|-7.86|6.39||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff <= -12.5%.|% Risk Difference (RD)|RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.||Statistical analysis for the proportion of patients with clinical cure at TOC in CE at TOC analysis set|
1644802|NCT01808092|3025314|Non-Inferiority or Equivalence|The statistical test of NI for the primary efficacy analysis will be performed at the 2.5% 1 sided significance level. This test will be based on the lower limit of a 2-sided 95% confidence interval (CI). Consistent with the protocol, NI will be concluded if the lower limit of the 95% CI is greater than -12.5%.|percentage: units for RD are %|-4.2||||0.007|2-Sided|95.0|-10.76|2.46||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff <= -12.5%.|% Risk Difference (RD)|RD is CAZ-AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.||Statistical analysis for the proportion of patients with clinical cure at TOC in cMITT analysis set|
1644803|NCT01807949|3025322|Superiority or Other||LS Mean Difference|7.16||||0.0045|2-Sided|95.0|2.23|12.08|||MMRM|||Global Satisfaction: analysis was performed as described in Statistical Analysis 1.|
1644895|NCT01806857|3025469|Superiority or Other|||||||0.0003|||||||Random Effects Model||||
1644804|NCT01807949|3025322|Superiority or Other||LS Mean Difference|4.64||||0.0668|2-Sided|95.0|-0.32|9.61|||MMRM|||Global Satisfaction: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline TSQM global satisfaction score.|
1644805|NCT01807949|3025322|Superiority or Other||LS Mean Difference|0.32||||0.8777|2-Sided|95.0|-3.74|4.37|||MMRM|||Convenience: analysis was performed as described in Statistical Analysis 1.|
1644806|NCT01807949|3025322|Superiority or Other||LS Mean Difference|0.0||||1|2-Sided|95.0|-4.07|4.07|||MMRM|||Convenience: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline TSQM convenience score.|
1644807|NCT01807949|3025322|Superiority or Other||LS Mean Difference|-4.29||||0.0054|2-Sided|95.0|-7.31|-1.28|||MMRM|||Side Effects: analysis was performed as described in Statistical Analysis 1.|
1644808|NCT01807949|3025322|Superiority or Other||LS Mean Difference|-3.18||||0.0403|2-Sided|95.0|-6.21|-0.14|||MMRM|||Side Effects: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline TSQM side effects score.|
1644809|NCT01807949|3025322|Superiority or Other||LS Mean Difference|11.61|||<|0.0001|2-Sided|95.0|6.75|16.48|||MMRM|||Effectiveness: analysis was performed as described in Statistical Analysis 1.|
1644810|NCT01807949|3025322|Superiority or Other||LS Mean Difference|8.64|||<|0.0005|2-Sided|95.0|3.77|13.51|||MMRM|||Effectiveness: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline TSQM effectiveness score.|
1644811|NCT01807949|3025323|Superiority or Other||LS Mean Difference|3.3||||0.0262|2-Sided|95.0|0.4|6.2|||MMRM|||Analysis was performed as described in Statistical Analysis 1.|
1644812|NCT01807949|3025323|Superiority or Other||LS Mean Difference|2.4||||0.1034|2-Sided|95.0|-0.5|5.3|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline EQ-5D-3L VAS score.|
1644813|NCT01807949|3025324|Superiority or Other||LS Mean Difference|-0.0009||||0.9214|2-Sided|95.0|-0.0192|0.0174|||MMRM|||Analysis was performed as described in Statistical Analysis 1.|
1644814|NCT01807949|3025324|Superiority or Other||LS Mean Difference|-0.0028||||0.7679|2-Sided|95.0|-0.0211|0.0156|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline EQ-5D-3L index score.|
1644815|NCT01807949|3025325|Superiority or Other||Odds Ratio (OR)|0.4429||||0.0002|2-Sided|95.0|0.2863|0.6851|||Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.|
1644816|NCT01807949|3025325|Superiority or Other||Odds Ratio (OR)|0.6373||||0.0393|2-Sided|95.0|0.416|0.9764|||Cochran-Mantel-Haenszel|||OR and 95% confidence intervals (CIs) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (<18 versus >=18 years old), and percent predicted FEV1 severity at Screening (<70 versus >=70).|
1644817|NCT01807949|3025326|Superiority or Other||Hazard Ratio (HR)|0.533||||0.0003|2-Sided||||||Cox Proportional Hazard Regression|||Analysis was performed as described in Statistical Analysis 1.|
1644818|NCT01807949|3025326|Superiority or Other||Hazard Ratio (HR)|0.716||||0.0384|2-Sided||||||Cox Proportional Hazard Regression|||Analysis was performed using Cox proportional hazard regression, time is the time-to-first event or censoring, with adjustment for sex (male versus female), age group at baseline (<18 versus >=18 years old), and percent predicted FEV1 severity at Screening (<70 versus >=70).|
1644819|NCT01807949|3025327|Superiority or Other||LS Mean Difference|0.2217||||0.0006|2-Sided|95.0|0.0961|0.3473|||MMRM|||Analysis was performed as described in Statistical Analysis 1.|
1644820|NCT01807949|3025327|Superiority or Other||LS Mean Difference|0.2313||||0.0005|2-Sided|95.0|0.1037|0.3589|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline BMI z-score.|
1644821|NCT01807949|3025328|Superiority or Other||LS Mean Difference|0.95||||0.0003|2-Sided|95.0|0.43|1.46|||MMRM|||Analysis was performed as described in Statistical Analysis 1.|
1644822|NCT01807949|3025328|Superiority or Other||LS Mean Difference|1.13|||<|0.0001|2-Sided|95.0|0.62|1.64|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline weight.|
1644823|NCT01807949|3025329|Superiority or Other||Event Rate Ratio|0.5659||||0.0002|2-Sided|95.0|0.4191|0.7641||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed as described in Statistical Analysis 1.|
1644824|NCT01807949|3025329|Superiority or Other||Event Rate Ratio|0.6912||||0.0116|2-Sided|95.0|0.5187|0.9209||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed using regression analysis for a negative binomial distribution with sex (male versus female), age group at baseline (<18 versus >=18 years old), and percent predicted FEV1 severity at Screening (<70 versus >=70) as covariates with the logarithm of time on study as the offset.|
1644825|NCT01807949|3025330|Superiority or Other||Odds Ratio (OR)|2.3834||||0.0001|2-Sided|95.0|1.5234|3.7286||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.|
1644826|NCT01807949|3025330|Superiority or Other||Odds Ratio (OR)|2.9568|||<|0.0001|2-Sided|95.0|1.8829|4.6431||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Odds Ratio (OR) and 95% confidence intervals (Cis) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (<18 versus >=18 years old), and percent predicted FEV1 severity at Screening (<70 versus >=70).|
1644827|NCT01807949|3025331|Superiority or Other||LS Mean Difference|2.85||||0.0736|2-Sided|95.0|-0.27|5.98|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.|
1644828|NCT01807949|3025331|Superiority or Other||LS Mean Difference|2.21||||0.1651|2-Sided|95.0|-0.91|5.33|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline CFQ-R respiratory domain score.|
1644829|NCT01807949|3025332|Superiority or Other||LS Mean Difference|0.36||||0.0001|2-Sided|95.0|0.17|0.54|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.|
1644830|NCT01807949|3025332|Superiority or Other||LS Mean Difference|0.41|||<|0.0001|2-Sided|95.0|0.23|0.59|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline BMI.|
1644831|NCT01807949|3025333|Superiority or Other||LS Mean Difference|5.25|||<|0.0001|2-Sided|95.0|2.69|7.81|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.|
1644832|NCT01807949|3025333|Superiority or Other||LS Mean Difference|4.42|||<|0.0007|2-Sided|95.0|1.86|6.98|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), and percent predicted FEV1 severity at Screening (<70 versus >=70).|
1644833|NCT01807949|3025334|Superiority or Other||LS Mean Difference|3.0|||<|0.0001|2-Sided|95.0|1.56|4.44|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.|
1644834|NCT01807949|3025334|Superiority or Other||Least Squares (LS) Mean Difference|2.62|||<|0.0004|2-Sided|95.0|1.18|4.06|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM) model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (less than [<] 18 versus greater than equal to [>=]18 years old), and percent predicted FEV1 severity at Screening (<70 versus >=70).|
1644835|NCT01807923|3025337|Superiority or Other||LS Mean Difference|6.72||||0.0109|2-Sided|95.0|1.55|11.89|||MMRM|||Global Satisfaction: analysis was performed as described in Statistical Analysis 1.|
1644836|NCT01807923|3025337|Superiority or Other||LS Mean Difference|5.49||||0.0345|2-Sided|95.0|0.4|10.58|||MMRM|||Global Satisfaction: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline TSQM global satisfaction score.|
1644837|NCT01807923|3025337|Superiority or Other||LS Mean Difference|3.08||||0.1472|2-Sided|95.0|-1.09|7.25|||MMRM|||Convenience: analysis was performed as described in Statistical Analysis 1.|
1644838|NCT01807923|3025337|Superiority or Other||LS Mean Difference|0.61||||0.7721|2-Sided|95.0|-3.5|4.71|||MMRM|||Convenience: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline TSQM convenience score.|
1644839|NCT01807923|3025337|Superiority or Other||LS Mean Difference|-4.74||||0.0029|2-Sided|95.0|-7.85|-1.63|||MMRM|||Side Effects: analysis was performed as described in Statistical Analysis 1.|
1644840|NCT01807923|3025337|Superiority or Other||LS Mean Difference|-4.18||||0.0074|2-Sided|95.0|-7.23|-1.13|||MMRM|||Side Effects: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline TSQM side effects score.|
1644841|NCT01807923|3025337|Superiority or Other||LS Mean Difference|5.8||||0.0126|2-Sided|95.0|1.25|10.35|||MMRM|||Effectiveness: analysis was performed as described in Statistical Analysis 1.|
1644842|NCT01807923|3025337|Superiority or Other||LS Mean Difference|5.49||||0.016|2-Sided|95.0|1.03|9.96|||MMRM|||Effectiveness: analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline TSQM effectiveness score.|
1644843|NCT01807923|3025338|Superiority or Other||LS Mean Difference|1.4||||0.3071|2-Sided|95.0|-1.3|4.2|||MMRM|||Analysis was performed as described in Statistical Analysis 1.|
1644844|NCT01807923|3025338|Superiority or Other||LS Mean Difference|2.1||||0.1342|2-Sided|95.0|-0.7|4.9|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline EQ-5D-3L VAS score.|
1644845|NCT01807923|3025339|Superiority or Other||LS Mean Difference|0.0095||||0.3613|2-Sided|95.0|-0.0109|0.0298|||MMRM|||Analysis was performed as described in Statistical Analysis 1.|
1644846|NCT01807923|3025339|Superiority or Other||LS Mean Difference|0.006||||0.5604|2-Sided|95.0|-0.0142|0.0262|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline EQ-5D-3L index score.|
1644847|NCT01807923|3025340|Superiority or Other||Odds Ratio (OR)|0.6438||||0.0512|2-Sided|95.0|0.4142|1.0005|||Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.|
1644982|NCT01803204|3025733|Superiority or Other||GEE|1.0||||1|2-Sided|99.0|||||GEE||||
1644848|NCT01807923|3025340|Superiority or Other||Odds Ratio (OR)|0.6565||||0.0552|2-Sided|95.0|0.4266|1.0103|||Cochran-Mantel-Haenszel|||OR and 95% confidence intervals (CIs) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (<18 versus >=18 years old), and percent predicted FEV1 severity at Screening (<70 versus >=70).|
1644849|NCT01807923|3025341|Superiority or Other||Hazard Ratio (HR)|0.691||||0.0385|2-Sided||||||Cox Proportional Hazard Regression|||Analysis was performed as described in Statistical Analysis 1.|
1644850|NCT01807923|3025341|Superiority or Other||Hazard Ratio (HR)|0.692||||0.0396|2-Sided||||||Cox Proportional Hazard Regression|||Analysis was performed using Cox proportional hazard regression, time is the time-to-first event or censoring, with adjustment for sex (male versus female), age group at baseline (<18 versus >=18 years old), and percent predicted FEV1 severity at Screening (<70 versus >=70).|
1644851|NCT01807923|3025342|Superiority or Other||LS Mean Difference|0.0781||||0.2713|2-Sided|95.0|-0.0615|0.2176|||MMRM|||Analysis was performed as described in Statistical Analysis 1.|
1644852|NCT01807923|3025342|Superiority or Other||LS Mean Difference|0.098||||0.1539|2-Sided|95.0|-0.037|0.233|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline BMI z-score.|
1644853|NCT01807923|3025343|Superiority or Other||LS Mean Difference|0.3||||0.2992|2-Sided|95.0|-0.26|0.86|||MMRM|||Analysis was performed as described in Statistical Analysis 1.|
1644854|NCT01807923|3025343|Superiority or Other||LS Mean Difference|0.4||||0.1565|2-Sided|95.0|-0.16|0.96|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline weight.|
1644855|NCT01807923|3025344|Superiority or Other||Event Rate Ratio|0.6643||||0.0169|2-Sided|95.0|0.4749|0.9291||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Negative Binomial Regression|||Analysis was performed as described in Statistical Analysis 1.|
1644856|NCT01807923|3025344|Superiority or Other||Event Rate Ratio|0.7186||||0.0491|2-Sided|95.0|0.517|0.9987|||Negative Binomial Regression|||Analysis was performed using regression analysis for a negative binomial distribution with sex (male versus female), age group at baseline (<18 versus >=18 years old), and percent predicted FEV1 severity at Screening (<70 versus >=70) as covariates with the logarithm of time on study as the offset.|
1644857|NCT01807923|3025345|Superiority or Other||Odds Ratio (OR)|2.0592||||0.0023|2-Sided|95.0|1.292|3.2819||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Analysis was performed as described in Statistical Analysis 1.|
1644858|NCT01807923|3025345|Superiority or Other||Odds Ratio (OR)|2.9378|||<|0.0001|2-Sided|95.0|1.8786|4.5941||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|Cochran-Mantel-Haenszel|||Odds Ratio (OR) and 95% confidence intervals (Cis) are Mantel-Haenszel estimates. P values are from a Cochran-Mantel-Haenszel test stratified by sex (male versus female), age group at baseline (<18 versus >=18 years old), and percent predicted FEV1 severity at Screening (<70 versus >=70).|
1644859|NCT01807923|3025346|Superiority or Other||LS Mean Difference|1.5||||0.3569|2-Sided|95.0|-1.69|4.69|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.|
1644860|NCT01807923|3025346|Superiority or Other||LS Mean Difference|3.88||||0.0168|2-Sided|95.0|0.7|7.05||This test is considered nominally significant because a hierarchical procedure was used and was broken prior to this test.|MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline CFQ-R respiratory domain score.|
1644861|NCT01807923|3025347|Superiority or Other||LS Mean Difference|0.13||||0.1938|2-Sided|95.0|-0.07|0.32|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.|
1644862|NCT01807923|3025347|Superiority or Other||LS Mean Difference|0.16||||0.1122|2-Sided|95.0|-0.04|0.35|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), percent predicted FEV1 severity at Screening (<70 versus >=70), and baseline BMI.|
1644863|NCT01807923|3025348|Superiority or Other||LS Mean Difference|4.33||||0.0006|2-Sided|95.0|1.86|6.8|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.|
1644864|NCT01807923|3025348|Superiority or Other||LS Mean Difference|6.73|||<|0.0001|2-Sided|95.0|4.27|9.19|||MMRM|||Analysis was performed using MMRM model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (<18 versus >=18 years old), and percent predicted FEV1 severity at Screening (<70 versus >=70).|
1644865|NCT01807923|3025349|Superiority or Other||LS Mean Difference|2.6||||0.0003|2-Sided|95.0|1.18|4.01|||MMRM|||Analysis was performed using MMRM model, as described in Statistical Analysis 1.|
1644866|NCT01807923|3025349|Superiority or Other||Least Squares (LS) Mean Difference|4.03|||<|0.0001|2-Sided|95.0|2.62|5.44|||MMRM|||Analysis was performed using mixed-effects model for repeated measures (MMRM) model including treatment, visit, and treatment-by-visit interaction as fixed effects with adjustments for sex (male versus female), age group at baseline (less than (<)18 versus greater than equal to (>=18) years old), and percent predicted FEV1 severity at Screening (<70 versus >=70).|
1644867|NCT01807871|3025350|Superiority|||||||0.24|||||||Chi-squared|||Comparison of number of participants who reported removing the nicotine patch due to a side effect|
1644868|NCT01807871|3025352|Superiority|||||||0.48|||||||Chi-squared||||
1644869|NCT01807650|3025361|Superiority or Other||Mean Difference (Final Values)|3.6|Standard Deviation|15.1|=|0|2-Sided|95.0|0.7|6.4||Day 28|t-test, 2 sided||Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)||
1644985|NCT01802554|3025784|Superiority or Other|||||||0.268|||||||Mixed Models Analysis||||
1644986|NCT01802554|3025785|Superiority or Other|||||||0.04|||||||Mixed Models Analysis||||
1644870|NCT01807650|3025361|Superiority or Other||Mean Difference (Final Values)|5.6|Standard Deviation|15.8|=|0|2-Sided|95.0|2.6|8.6||Day 21|t-test, 2 sided||Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)||
1644871|NCT01807650|3025361|Superiority or Other||Mean Difference (Final Values)|5.9|Standard Deviation|18.0|=|0|2-Sided|95.0|2.5|9.3||Day 18|t-test, 2 sided||Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)||
1644872|NCT01807650|3025361|Superiority or Other||Mean Difference (Final Values)|5.6|Standard Deviation|19.3|=|0|2-Sided|95.0|2.0|9.3||Day 14|t-test, 2 sided||Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)||
1644873|NCT01807650|3025361|Superiority or Other||Mean Difference (Final Values)|6.2|Standard Deviation|16.9|=|0|2-Sided|95.0|3.0|9.4||Day 10|t-test, 2 sided||Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)||
1644874|NCT01807650|3025361|Superiority or Other||Mean Difference (Final Values)|6.1|Standard Deviation|17.8|=|0|2-Sided|95.0|2.7|9.4||Day 7|t-test, 2 sided||Mean difference in degree of epithelialization [%] (Oleogel-S10 and non-adhesive wound dressing minus non-adhesive wound dressing only)||
1644875|NCT01807650|3025365|Superiority or Other||||||=|0||||||2-sided, significance level = 0.05|t-test, 2 sided|||"All participants received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: δ = 0 and H1: δ ≠ 0 with δ being the difference in time to wound closure between treatments."|
1644876|NCT01807637|3025366|Superiority||Mean Difference (Final Values)|15.67|Standard Deviation|3.41||0.05|2-Sided||||||ANOVA||||
1644877|NCT01807637|3025367|Superiority||Mean Difference (Final Values)|-2.05|Standard Deviation|1.12||0.05|2-Sided||||||ANOVA||||
1644878|NCT01807637|3025368|Superiority||Mean Difference (Final Values)|9.1|Standard Error of the Mean|5.37||0.05|2-Sided||||||Mixed Models Analysis||||
1644879|NCT01807585|3025392|Non-Inferiority|Non-inferiority was determined by the application of a Z-test with a 10% non-inferiority margin as well as examination of confidence intervals.|Risk Difference (RD)|3.5|||<|0.0001|2-Sided|95.0|-0.7|7.6|||One tailed Z-test|||Last Observation Carried Forward (LOCF)|
1644880|NCT01807520|3025396|Superiority or Other||Mean Difference (Net)|-34.4|Standard Error of the Mean|5.47|<|0.0001|2-Sided|95.0|-45.2|-23.5|||Mixed model repeated measures||||
1644881|NCT01807520|3025396|Superiority or Other||Mean Difference (Net)|-26.7|Standard Error of the Mean|6.26|<|0.0001|2-Sided|95.0|-39.1|-14.3|||Mixed model reapeated measures||||
1644882|NCT01807299|3025402|Other||Mean Difference (Final Values)|5.0||||0.05|1-Sided|5.0|||||Chi-squared, Corrected||||
1644883|NCT01806896|3025442|Superiority or Other||Least square mean|16.35|Standard Error of the Mean|3.58|<|0.01|2-Sided|90.0|10.46|22.24||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-1 Euro) Day 28|
1644884|NCT01806896|3025442|Superiority or Other||Least square mean|4.78|Standard Error of the Mean|3.58|<|0.18|2-Sided|90.0|-1.11|10.67||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-0.1 Euro) Day 28|
1644885|NCT01806896|3025442|Superiority or Other||Least square mean|0.98|Standard Error of the Mean|3.58|<|0.78|2-Sided|90.0|-4.91|6.87||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Monetary Incentive-0.01 Euro) Day 28|
1644886|NCT01806896|3025442|Superiority or Other||Least square mean|7.28|Standard Error of the Mean|3.56|<|0.04|2-Sided|90.0|1.41|13.15||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Negative) Day 28|
1644887|NCT01806896|3025442|Superiority or Other||Least square mean|7.57|Standard Error of the Mean|3.57|<|0.03|2-Sided|90.0|1.69|13.45||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Positive) Day 28|
1644888|NCT01806896|3025442|Superiority or Other||Least square mean|7.3|Standard Error of the Mean|3.57|<|0.04|2-Sided|90.0|1.43|13.18||2-sided p-value|ANCOVA|Mixed effect model including treatment, incentive and treatment*incentive as fixed effects; baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Emotional Incentive-Neutral) Day 28|
1644889|NCT01806896|3025445|Superiority or Other||Least square mean|-0.53|Standard Error of the Mean|0.33||0.13|2-Sided|90.0|-1.1|0.04||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Out_win_Rew>Out_win N Right VS)|
1644890|NCT01806896|3025445|Superiority or Other||Least square mean|-0.25|Standard Error of the Mean|0.37||0.51|2-Sided|90.0|-0.89|0.4||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Out_win_Rew>Out_win N Left VS)|
1644891|NCT01806896|3025445|Superiority or Other||Least square mean|-0.15|Standard Error of the Mean|0.37||0.7|2-Sided|90.0|-0.8|0.51||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Cue Rew>Neut Right VS)|
1644892|NCT01806896|3025445|Superiority or Other||Least square mean|-0.1|Standard Error of the Mean|0.36||0.79|2-Sided|90.0|-0.72|0.52||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effect and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Cue Rew>Neut Left VS)|
1644893|NCT01806896|3025447|Superiority or Other||Mean Difference (Final Values)|-0.71|Standard Error of the Mean|1.68||0.68|2-Sided|90.0|-3.56|2.15||2-sided p-value|ANCOVA|Treatment differences are based on a mixed effect model including treatment as fixed effects and baseline, age, gender and CAG repeats as covariates.||PF-02545920 versus Placebo (Day 28)|
1644896|NCT01806714|3025480|Superiority or Other||Cox Proportional Hazard|1.3|||<|0.04|2-Sided|95.0|1.0|1.6|||clustered stratified Proportional Hazard||We determined hazard ratios using a clustered stratified Cox model with the Efron method to handle tied events and the Huber/White variance estimator that clustered on primary care provider and stratified on practice.||
1644897|NCT01806597|3025507|Superiority or Other||Odds Ratio (OR)|29.4|||<|0.0001|2-Sided|95.0|4.1|211.9|||Cochran-Mantel-Haenszel|||Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (<90 kg or ≥90 kg).|
1644898|NCT01806597|3025507|Superiority or Other||Odds Ratio (OR)|19.3|||<|0.0002|2-Sided|95.0|2.4|154.6|||Cochran-Mantel-Haenszel|||Data at Week 16 was analyzed using the stratified Cochran-Mantel-Haenszel-test. The test was stratified by body-weight category (<90 kg or ≥90 kg).|
1644899|NCT01806584|3025508|Superiority or Other||Mean treatment difference|0.23|||||2-Sided|95.0|-0.942|1.402|||||||
1644900|NCT01806584|3025509|Superiority or Other|||||||0.093||||||p-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency|
1644901|NCT01806584|3025510|Superiority or Other|||||||0.312||||||p-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency|
1644902|NCT01806584|3025511|Superiority or Other|||||||0.138||||||p-value based on log rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency|
1644903|NCT01806545|3025521|Superiority or Other||Mean treatment difference|0.565|||||2-Sided|95.0|-0.023|1.152||||||Analysis of week 26|
1644904|NCT01806545|3025521|Superiority or Other||Mean treatment difference|0.154|||||2-Sided|95.0|-0.096|0.404||||||Analysis of week 12|
1644905|NCT01806545|3025522|Superiority or Other||Proportion treatment difference|0.08|||||2-Sided|95.0|-0.165|0.318||||||Analysis of week 26|
1644906|NCT01806545|3025522|Superiority or Other||Proportion treatment difference|-0.04|||||2-Sided|95.0|-0.273|0.2||||||Analysis of week 12|
1644907|NCT01806545|3025523|Superiority or Other||Mean treatment difference|-0.232|||||2-Sided|95.0|-1.791|1.327||||||Treatment difference at week 26|
1644908|NCT01806545|3025523|Superiority or Other||Mean treatment difference|-0.895|||||2-Sided|95.0|-2.213|0.423||||||Treatment difference at week 12|
1644909|NCT01806545|3025524|Superiority or Other|||||||0.158||||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency|
1644910|NCT01806545|3025525|Superiority or Other|||||||0.231||||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank|||Analysis of time to loss of patency|
1644911|NCT01806545|3025526|Superiority or Other|||||||0.193|||||||Log Rank|P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.||Analysis of time to loss of patency|
1644912|NCT01806545|3025527|Superiority or Other|||||||0.09||||||P-value based on log-rank test stratified by diabetic status at surgery comparing the 2 treatment groups.|Log Rank||||
1644913|NCT01806545|3025528|Superiority or Other||Proportion treatment difference|-0.08||||0.1962|2-Sided|95.0|-0.204|0.045||P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.|Cochran-Mantel-Haenszel||||
1644914|NCT01806545|3025529|Superiority or Other||Proportion treatment difference|-0.11||||0.1197|2-Sided|95.0|-0.242|0.025||P-value was based on Cochran-Mantel-Haenszel test stratified by diabetic status at surgery comparing the 2 treatment groups.|Cochran-Mantel-Haenszel||||
1644915|NCT01805089|3025607|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1644916|NCT01804946|3025612|Non-Inferiority or Equivalence|The clinically significant difference (margin) between two percentages was assumed to be 20% or more of the effect of Oseltamivir|Risk Difference (RD)|0.0|||<|0.05|1-Sided|95.0|||||The Wald method of Z statistics calcul|The Wald method of Z statistics calculation was performed including computation a confidence interval for a difference between proportions||PP set was analyzed|
1644917|NCT01804946|3025613|Non-Inferiority or Equivalence|To compare the patient subjective health status assessment the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value|Mean Difference (Final Values)|0.0|Standard Deviation|18.2|<|0.05|1-Sided|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval||PP set was analyzed|
1644918|NCT01804946|3025614|Non-Inferiority or Equivalence|To compare the quality of life total score the margin of no clinical importance was assumed to be 0.2 of Oseltamivir group value|Mean Difference (Final Values)|0.0|Standard Deviation|2.2|<|0.05|1-Sided|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|The changes of means (Day 7 vs Day 1) were compared using the modified two-sample Student t-test including computation of a confidence interval||PP set was analyzed|
1644919|NCT01804946|3025615|Non-Inferiority or Equivalence|To compare the number of antipyretic intake the margin of no clinical importance was assumed to be 0.2|Mean Difference (Final Values)|0.0|Standard Deviation|0.5|<|0.05|1-Sided|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed|
1644920|NCT01804946|3025616|Non-Inferiority or Equivalence|The margin of no clinical importance was assumed to be 0.5 point or less to assess any symptom based on 4 point scale.|Mean Difference (Final Values)|0.0|||<|0.05|1-Sided|95.0||||To adjust for multiple comparisons the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed|
1644921|NCT01804946|3025617|Non-Inferiority or Equivalence|The clinically significant margin was assumed to be 0.2°C|Mean Difference (Final Values)|0.0|Standard Deviation|0.5|<|0.05|1-Sided|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means.||PP set was analyzed|
1644922|NCT01804946|3025618|Non-Inferiority or Equivalence|The clinically significant margin was assumed to be 0.2 of Oseltamivir effect|Mean Difference (Final Values)|0.0|||<|0.05|1-Sided|95.0||||To adjust for multiple comparisons, the adaptive Holm method was used as a way to control type 1 error|t-test, 1 sided|Means were compared using the modified two-sample Student t-test including computation of a confidence interval for a difference between means||PP set was analyzed|
1644923|NCT01804946|3025619|Non-Inferiority or Equivalence|The pre-determined margin of 20% of the control group effect was used.|Risk Difference (RD)|0.0|||<|0.05|1-Sided|95.0||||One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method|Wald method of Z statistics calculation|Wald method of Z statistics computed a confidence interval of proportion difference.||PP set was analyzed|
1644924|NCT01804946|3025620|Non-Inferiority or Equivalence|The pre-determined margin of 20% of the control group effect was used.|Risk Difference (RD)|0.0||||0.05|1-Sided|95.0||||One-sided, p-value was adjusted for multiple comparisons using the adaptive Holm method|Wald method of Z statistics calculation|Wald method of Z statistics computed a confidence interval of proportion difference.||PP set was analyzed|
1644925|NCT01804842|3025624|Superiority or Other||% Ratio of LS Means|94.3||||0.0389|2-Sided|95.0|89.24|99.69|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.|
1644926|NCT01804842|3025624|Superiority or Other||% Ratio of LS Means|90.5||||0.0007|2-Sided|95.0|85.65|95.67|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.|
1644927|NCT01804842|3025624|Superiority or Other||% Ratio of LS Means|90.4||||0.0006|2-Sided|95.0|85.55|95.56|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.|
1644928|NCT01804842|3025625|Superiority or Other||% Ratio of LS Means|95.1||||0.0992|2-Sided|95.0|89.54|100.99|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.|
1644929|NCT01804842|3025625|Superiority or Other||% Ratio of LS Means|90.9||||0.0024|2-Sided|95.0|85.58|96.53|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.|
1644930|NCT01804842|3025625|Superiority or Other||% Ratio of LS Means|91.0||||0.0028|2-Sided|95.0|85.7|96.67|||ANOVA|Treatment, sequence, period, status (on-/pre-treatment) and treatment*status as fixed effects and subject nested within sequence as a random effect.||Pretreatment value is the denominator for the % ratio of LS means and the comparator for the p-values.|
1644931|NCT01804842|3025626|Superiority or Other||% Ratio of LS Means|132.7||||0.0294|2-Sided|90.0|107.78|163.39|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.|
1644932|NCT01804842|3025626|Superiority or Other||% Ratio of LS Means|111.3||||0.3867|2-Sided|90.0|90.37|136.99|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.|
1644933|NCT01804842|3025626|Superiority or Other||% Ratio of LS Means|83.8||||0.1595|2-Sided|90.0|68.1|103.23|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met DR qPM is the denominator for the % ratio of LS means and the comparator for the p-values.|
1644934|NCT01804842|3025627|Superiority or Other||% Ratio of LS Means|99.8||||0.9844|2-Sided|90.0|84.91|117.33|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.|
1644935|NCT01804842|3025627|Superiority or Other||% Ratio of LS Means|71.5||||0.002|2-Sided|90.0|60.85|84.09|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||500 mg Met DR BID is the denominator for the % ratio of LS means and the comparator for the p-values.|
1644936|NCT01804842|3025627|Superiority or Other||% Ratio of LS Means|71.7||||0.0018|2-Sided|90.0|61.14|84.01|||ANOVA|Included treatment, sequence, and period and as fixed effects and subject nested within sequence as a random effect.||1000 mg Met DR qPM is the denominator for the % ratio of least squares (LS) means and the comparator for the p-values.|
1644937|NCT01804816|3025628|Equivalence|a=0.05||||||0.729|||||||t-test, 2 sided||||
1644938|NCT01804816|3025629|Equivalence|a=0.05||||||0.441|||||||t-test, 2 sided||||
1644939|NCT01804816|3025629|Equivalence|a=0.05||||||0.002|||||||t-test, 2 sided||||
1644940|NCT01804816|3025629|Equivalence|a = 0.05||||||0.005|||||||t-test, 2 sided|||Based on results from prior small clinical trials we estimate the need for 20 patients enrolled to reach 80% statistical power.|
1644941|NCT01804816|3025630|Equivalence|a=0.05||||||0.063|||||||t-test, 2 sided||||
1644942|NCT01804582|3025644|Superiority or Other (legacy)||Phi|0.19||||0.005|2-Sided||||||Chi-squared|Chi Squared (1, N = 229) = 7.99.||The total n=229 included those on medication at 90 days (119 never filled the prescription or changed to a different med)|
1644943|NCT01804582|3025645|Superiority or Other (legacy)|||||||0.21|||||||Wald Chi-Squared||||
1644944|NCT01804582|3025646|Superiority or Other (legacy)|||||||0.33|||||||Mixed Models Analysis||||
1644945|NCT01804582|3025647|Superiority or Other (legacy)||Mean Difference (Final Values)|0.03||||0.8|2-Sided||||||Mixed Models Analysis||||
1644946|NCT01804582|3025648|Superiority or Other (legacy)||Mean Difference (Final Values)|0.07||||0.53|2-Sided||||||Mixed Models Analysis||Cohen's d was calculated to measure the estimation parameter.||
1644983|NCT01802775|3025768|Other||Treatment Difference|-3.9|||||2-Sided|95.0|-17.3|9.5||||||Treatment difference was edoxaban - clopidogrel. For the treatment difference, 95% Confidence interval was calculated using a normal approximation to the binomial distribution.|
1644947|NCT01804582|3025649|Superiority or Other (legacy)|||||||0.15|||||||Mixed Models Analysis|||An intent to treat analysis was conducted using a linear mixed model to determine if there was any significant difference in change from baseline to 3 months based on time and condition. Data for all participants was included at baseline and 3 months.|
1644948|NCT01804075|3025660|Superiority|||||||0.6|||||||Chi-squared||||
1644949|NCT01804049|3025665|Superiority|||||||0.48|||||||t-test, 2 sided|t(118)=0.703, p=0.48|||
1644950|NCT01804049|3025666|Superiority|Hypothesis: metformin will reduce loss of total appendicular lean mass in insulin-resistant older adults over a three year period. It was determined (prior to the initiation of the study) that a sample size of 60 participants per group will have a 73% power to detect a 0.09 m/s difference in gait speed.||||||0.79||||||For lean appendicular body mass, t(118) = 0.264, p=0.79.|t-test, 2 sided|T-test calculation appendicular lean mass: 0.26.|||
1644951|NCT01804049|3025666|Superiority|Hypothesis: metformin will reduce loss of total lean mass in insulin-resistant older adults over a three year period. It was determined (prior to the initiation of the study) that a sample size of 60 participants per group will have a 73% power to detect a 0.09 m/s difference in gait speed.||||||0.45||||||For lean total body mass, t(118)=0.744, p=0.45.|t-test, 2 sided|T-test calculation for total lean mass: 0.74.|||
1644952|NCT01804036|3025667|Superiority or Other|||||||0.13|||||||ANCOVA||||
1644953|NCT01804036|3025668|Superiority or Other||||||<|0.01|||||||ANCOVA||||
1644954|NCT01804036|3025669|Superiority or Other||||||<|0.01|||||||ANCOVA||||
1644955|NCT01804036|3025670|Superiority or Other|||||||0.49|||||||ANCOVA||||
1644956|NCT01804036|3025671|Superiority or Other|||||||0.95|||||||ANCOVA||||
1644957|NCT01804036|3025672|Superiority or Other|||||||0.94|||||||ANCOVA||||
1644958|NCT01804036|3025673|Superiority or Other|||||||0.54|||||||ANCOVA||||
1644959|NCT01804036|3025674|Superiority or Other|||||||0.52|||||||ANCOVA||||
1644960|NCT01804036|3025675|Superiority or Other|||||||0.13|||||||ANCOVA||||
1644961|NCT01804036|3025676|Superiority or Other|||||||0.2|||||||ANCOVA||||
1644962|NCT01804036|3025677|Superiority or Other|||||||0.08|||||||ANCOVA||||
1644963|NCT01804036|3025678|Superiority or Other|||||||0.95|||||||ANCOVA||||
1644964|NCT01804036|3025679|Superiority or Other|||||||0.11|||||||ANCOVA||||
1644965|NCT01804036|3025680|Superiority or Other|||||||0.84|||||||ANCOVA||||
1644966|NCT01803880|3025694|Non-Inferiority|"Non-inferiority Margin = 10 points. Non-inferiority of study device was concluded if lower limit of one-sided 97.5% CI for treatment difference <10.~Superiority of study device was established if LS means of treatment difference and lower limit of one-sided 97.5% CI for treatment difference ≤0."|One-sided 97.5% confidence interval (CI)|-7.42|Standard Error of the Mean|5.137|>|0.05|1-Sided|97.5|-19.29|||All unscheduled visits were to be included and nominal visits were to be applied using analysis visit windows. Both the assigned analysis visits and the site reported nominal visits were provided in the subject data listings.|ANCOVA|Due to early termination, all inferential analysis was interpreted as descriptive and carried out in an exploratory manner.||An ANCOVA model was used to compare the difference in the devices for change from Baseline in the KOOS at Week 52. KOOS was derived as the average of five subscale scores. LOCF imputation was considered for missing value. One-sided 97.5% confidence interval (CI) for treatment difference (Study–Control) was to be used for determining non-inferiority/superiority of the study device.|
1644967|NCT01803646|3025710|Superiority|||||||1|||||||Fisher Exact|||Analysis for bone conduction|
1644968|NCT01803646|3025710|Superiority|||||||0.821|||||||Fisher Exact|||Analysis for air conduction|
1644969|NCT01803646|3025711|Superiority||Mean Difference (Net)|-0.79||||0.63|2-Sided|95.0|-4.0|2.4|||Mixed Models Analysis||||
1644970|NCT01803646|3025712|Superiority||Mean Difference (Net)|-0.17||||0.32|2-Sided|95.0|-0.51|0.17|||Mixed Models Analysis||||
1644971|NCT01803464|3025721|Other||Cohen's d|0.33|||||2-Sided||||||||Cohen's d was calculated. The % change of the typically developing control group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.||
1644972|NCT01803464|3025721|Other||Cohen's d|0.33|||||2-Sided||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.||
1644973|NCT01803464|3025721|Other||Cohen's d|1.2|||||2-Sided||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.||
1644974|NCT01803464|3025722|Other||Cohen's d|0.13|||||2-Sided||||||||Cohen's d was calculated. The % change of the typically developing group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator||
1644975|NCT01803464|3025722|Other||Cohen's d|0.57|||||2-Sided||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.||
1644976|NCT01803464|3025722|Other||Cohen's d|0.45|||||2-Sided||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator||
1644977|NCT01803464|3025723|Other||Cohen's d|0.51|||||2-Sided||||||||Cohen's d was calculated. The % change of the typically developing control group group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.||
1644978|NCT01803464|3025723|Other||Cohen's d|0.13|||||2-Sided||||||||Cohen's d was calculated. The % change of the Botox group minus the % change of the cerebral palsy control group was the numerator. The pooled SD of the % change for the 2 groups was the denominator.||
1644979|NCT01803464|3025723|Other||Cohen's d|0.59|||||2-Sided||||||||Cohen's d was calculated. The % change of the Botox plus low-magnitude vibration group minus the % change of the cerebral palsy control group was the numerator. The pooled Standard Deviation (SD) of the % change for the 2 groups was the denominator.||
1644980|NCT01803204|3025731|Superiority or Other|||||||0.81|||||||Mist Effect Model||||
1644981|NCT01803204|3025732|Superiority or Other||||||<|0.01|||||||Mist Effects Model||||
1644987|NCT01802554|3025786|Superiority or Other|||||||0.701|||||||Mixed Models Analysis||||
1644988|NCT01802554|3025787|Superiority or Other|||||||0.039|||||||Mixed Models Analysis||||
1644989|NCT01802333|3025808|Other|||||||0.52|||||||Regression, Cox|Adjusted for: Age (< 40 vs. >= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm I was compared with Arm II using a two-sided test of the null hypothesis (HR=1).|
1644990|NCT01802333|3025810|Other||||||<|0.0001|||||||Exact binomial test, 1-sided||||
1644991|NCT01802333|3025811|Other|||||||0.42|||||||Regression, Cox|Adjusted for: Age (< 40 vs. >= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm II was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.|
1644992|NCT01802333|3025811|Other|||||||0.84|||||||Regression, Cox|Adjusted for: Age (< 40 vs. >= 40) and Onset of AML (de novo vs. treatment related and/or AML arising from antecedent hematologic disease)||Arm I was compared with Arm III using a two-sided test of the null hypothesis (HR=1) at the 0.045 level.|
1644993|NCT01801917|3025850|Superiority or Other||Bayesian|0.837||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. . For this table the value is the PP of achieving an increase of 15 points in MMT24 and a decrease of 30% in CK in 10mg group vs. placebo|
1644994|NCT01801917|3025850|Superiority or Other||Bayesian|0.963||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. For this table the value is the posterior probability of achieving an increase in MMT24 and a decrease in CK in 10mg group vs. placebo|
1644995|NCT01801917|3025850|Superiority or Other||Bayesian|0.022||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. . For this table the value is the PP of achieving an increase of 15 points in MMT24 and a decrease of 30% in CK in 2mg group vs. placebo|
1644996|NCT01801917|3025850|Superiority or Other||Bayesian|0.586||||||||||||||It was a Bayesian analysis with non-informative prior for co-primary endpoints, MMT-24 and CK, with dual criteria for statistical significance: ≥ 90% posterior probability (PP) of achieving an increase from baseline in MMT24 and decrease in CK and clinical relevance: ≥ 50% PP achieving an increase of 15 points in MMT24 and a decrease of 30% in CK vs. placebo. For this table the value is the posterior probability of achieving an increase in MMT24 and a decrease in CK in 2mg group vs. placebo|
1644997|NCT01801475|3025852|Superiority or Other||||||<|0.05|||||||Chi-squared|||The nonlinear mixed-effects modeling software program NONMEM (version VII; Icon Development Solutions, Ellicott City, MD) was used to estimate the pharmacokinetic parameters. The first-order conditional estimation (FOCE) with η-ε interaction was used for the estimation process. Volume and clearance in this model is computed as a mean of the study population (pregnant and non-pregnant women) with a log-normal distribution in the population.|
1644998|NCT01801475|3025853|Superiority or Other||||||<|0.05|||||||Chi-squared|||The nonlinear mixed-effects modeling software program NONMEM (version VII; Icon Development Solutions, Ellicott City, MD) was used to estimate the pharmacokinetic parameters. The first-order conditional estimation (FOCE) with η-ε interaction was used for the estimation process. Volume and clearance in this model is computed as a mean of the study population (pregnant and non-pregnant women) with a log-normal distribution in the population.|
1644999|NCT01801111|3025950|Other|||||||0.0001|||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.|
1645000|NCT01801111|3025952|Other|||||||0.0599|||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.|
1645001|NCT01801111|3025953|Other|||||||0.0005|||||||Exact Clopper-Pearson CI|||Tests null hypothesis that the objective response rate (ORR) is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.|
1645002|NCT01800968|3025956|Superiority or Other|||||||0.2033|||||||Rank score||||
1645003|NCT01800968|3025957|Superiority or Other|||||||0.6532|||||||Regression, Linear||||
1645004|NCT01800968|3025958|Superiority or Other|||||||0.1701|||||||Log Rank||||
1645005|NCT01800968|3025959|Superiority or Other|||||||0.7764|||||||Log Rank||||
1645006|NCT01800968|3025960|Superiority or Other|||||||0.8088|||||||Regression, Linear||||
1645007|NCT01800968|3025961|Superiority or Other|||||||0.1124|||||||Regression, Linear||||
1645008|NCT01800968|3025962|Superiority or Other|||||||0.8218|||||||Regression, Linear||||
1645009|NCT01800968|3025963|Superiority or Other|||||||0.6395|||||||Regression, Linear||||
1645010|NCT01800968|3025964|Superiority or Other|||||||0.2662|||||||Regression, Linear||||
1645011|NCT01800968|3025965|Superiority or Other|||||||0.7026|||||||Regression, Linear||||
1645012|NCT01800968|3025966|Superiority or Other|||||||0.792|||||||Regression, Linear||||
1645013|NCT01800968|3025967|Superiority or Other|||||||0.1309|||||||Regression, Linear||||
1645014|NCT01800968|3025968|Superiority or Other|||||||0.1705|||||||Regression, Linear||||
1645015|NCT01800968|3025969|Superiority or Other|||||||0.4266|||||||Regression, Linear||||
1645016|NCT01800968|3025970|Superiority or Other|||||||0.8548|||||||Regression, Linear||||
1645017|NCT01800968|3025971|Superiority or Other|||||||0.9535|||||||Regression, Linear||||
1645018|NCT01800968|3025972|Superiority or Other|||||||0.1932|||||||Regression, Linear||||
1645019|NCT01800968|3025973|Superiority or Other|||||||0.1549|||||||Regression, Linear||||
1645020|NCT01800968|3025974|Superiority or Other|||||||0.3087|||||||Rank score||||
1645021|NCT01800318|3025982|Superiority or Other|||||||0.008|||||||ANOVA|F4.048|||
1645022|NCT01800318|3025984|Superiority or Other|||||||0.9|||||||ANOVA||||
1645023|NCT01800318|3025985|Superiority or Other|||||||0.9|||||||ANOVA||||
1645024|NCT01800318|3025986|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|Bonferroni||t test comparing baseline PIPP score with heel stick PIPP scores in standard care group (Sham NESAP with oral water).|
1645025|NCT01800318|3025986|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with 24% sucrose and NESAp combined.|
1645026|NCT01800318|3025986|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with NESAP and oral water.|
1645027|NCT01800318|3025986|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|Bonferroni correction||t test comparing baseline PIPP score with heel stick PIPP scores in group with 24% sucrose and sham NESAP.|
1645028|NCT01800318|3025986|Superiority or Other||||||<|0.07||||||RM Anova of effects of treatment groups on PIPP scores: .|ANOVA||||
1645029|NCT01799993|3026010|Superiority|||||||0.4278|||||||ANOVA||||
1645030|NCT01799993|3026011|Superiority|||||||0.7144|||||||ANOVA||||
1645031|NCT01799993|3026012|Superiority|||||||0.7984|||||||Chi-squared||||
1645032|NCT01799993|3026013|Superiority|||||||0.6421|||||||Chi-squared||||
1645033|NCT01799993|3026014|Superiority||Odds Ratio (OR)|0.841||||0.4263|2-Sided|95.0|0.554|1.277|||Cochran-Mantel-Haenszel||||
1645034|NCT01799941|3026019|Superiority or Other||||||<|0.0001|||||||One-sample t-test||||
1645035|NCT01799941|3026019|Superiority or Other||||||<|0.0001|||||||One-sample t-test||||
1645036|NCT01799941|3026019|Superiority or Other||||||<|0.0001|||||||One-sample t-test||||
1645037|NCT01799941|3026019|Superiority or Other||||||<|0.0001|||||||One-sample t-test||||
1645038|NCT01799941|3026022|Superiority or Other||Incidence Rate Ratio|0.215|Standard Error of the Mean|0.066|<|0.0001|2-Sided|95.0|0.189|0.245|||Mixed Effects Poisson Regression Model||Number of observations = 239, Number of participants = 87|Day 90 assessment|
1645039|NCT01799941|3026022|Superiority or Other||Incidence Rate Ratio|0.387|Standard Error of the Mean|0.048|<|0.0001|2-Sided|95.0|0.352|0.425|||Mixed Effects Poisson Regression Model||Number of observations = 239, Number of participants = 87|Day 30 assessment|
1645040|NCT01799941|3026022|Superiority or Other||Incidence Rate Ratio|0.255|Standard Error of the Mean|0.051|<|0.0001|2-Sided|95.0|0.231|0.282|||Mixed Effects Poisson Regression Model||Number of observations = 297, Number of participants = 103|Day 90 assessment|
1645041|NCT01799941|3026022|Superiority or Other||Incidence Rate Ratio|0.351|Standard Error of the Mean|0.044|<|0.0001|2-Sided|95.0|0.323|0.383|||Mixed Effects Poisson Regression Model||Number of observations = 297, Number of participants = 103|Day 30 assessment|
1645042|NCT01799941|3026022|Superiority or Other||Incidence Rate Ratio|0.323|Standard Error of the Mean|0.039|<|0.0001|2-Sided|95.0|0.299|0.349|||Mixed Effects Poisson Regression Model||Number of observations = 318, Number of participants = 108|Day 90 assessment|
1645043|NCT01799941|3026022|Superiority or Other||Incidence Rate Ratio|0.5|Standard Error of the Mean|0.033|<|0.0001|2-Sided|95.0|0.469|0.534|||Mixed Effects Poisson Regression Model||Number of observations = 318, Number of participants = 108|Day 30 assessment|
1645044|NCT01799941|3026022|Superiority or Other||Incidence Rate Ratio|0.277|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.262|0.293|||Mixed Effects Poisson Regression Model||Number of observations = 854, Number of participants = 298|Day 90 assessment|
1645045|NCT01799941|3026022|Superiority or Other||Incidence Rate Ratio|0.425|Standard Error of the Mean|0.023|<|0.0001|2-Sided|95.0|0.407|0.445|||Mixed Effects Poisson Regreesion Model||Number of observations = 854, Number of participants = 298|Day 30 assessment|
1645046|NCT01799941|3026024|Superiority or Other||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline|
1645047|NCT01799941|3026024|Superiority or Other||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline|
1645048|NCT01799941|3026024|Superiority or Other||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline|
1645049|NCT01799941|3026024|Superiority or Other||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline|
1645050|NCT01799941|3026024|Superiority or Other||||||<|0.0001|||||||One-sample t-test|||Day 90 assessment|
1645051|NCT01799941|3026024|Superiority or Other||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline|
1645052|NCT01799941|3026024|Superiority or Other||||||<|0.0001|||||||One-sample t-test|||Day 90 versus Baseline|
1645053|NCT01799941|3026024|Superiority or Other||||||<|0.0001|||||||One-sample t-test|||Day 30 versus Baseline|
1645054|NCT01799941|3026025|Superiority or Other||||||<|0.0001|||||||One-sample t-test||||
1645055|NCT01799941|3026025|Superiority or Other||||||<|0.0001|||||||One-sample t-test||||
1645056|NCT01799941|3026025|Superiority or Other||||||<|0.0001|||||||One-sample t-test||||
1645057|NCT01799941|3026025|Superiority or Other||||||<|0.0001|||||||One-sample t-test||||
1645058|NCT01799941|3026026|Superiority or Other||ANCOVA|1.15|Standard Error of the Mean|0.78|||2-Sided|95.0|-0.39|2.69|||||A positive estimate indicates a smaller change in the first group. Observations used =261.||
1645059|NCT01799941|3026026|Superiority or Other||ANCOVA|1.11|Standard Error of the Mean|0.8|||2-Sided|95.0|-0.46|2.68|||||A positive estimate indicates a smaller change in the first group. Observations used =261.||
1645060|NCT01799941|3026026|Superiority or Other||Analysis of covariance (ANCOVA)|0.04|Standard Error of the Mean|0.72|||2-Sided|95.0|-1.37|1.45|||||A positive estimate indicates a smaller change in the first group. Observations used =261.||
1645061|NCT01799941|3026026|Superiority or Other||||||<|0.0001|||||||One-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.|
1645062|NCT01799941|3026026|Superiority or Other||||||<|0.0001|||||||One-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.|
1645063|NCT01799941|3026026|Superiority or Other||||||<|0.0001|||||||one-sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.|
1645237|NCT01796236|3026402|Superiority or Other|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Week 12|
1645064|NCT01799941|3026026|Superiority or Other||||||<|0.0001|||||||One sample t-test|||The primary analysis tested the null hypothesis that the mean change in CNS-LS score from Baseline to Day 90 visit is equal to zero.|
1645065|NCT01798992|3026069|Superiority or Other|||||||0.071|||||||Fisher Exact|||The null hypothesis is that there is no difference in rate of LVEF improvement according to treatment group.|
1645066|NCT01798992|3026070|Superiority or Other|||||||0.685|||||||Fisher Exact|||The null hypothesis is that there is no difference in rate of LVEF improvement according to treatment group.|
1645067|NCT01798849|3026094|Other||Difference in LS means|-3.78||||0.006|2-Sided|95.0|-6.37|-1.19|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645068|NCT01798849|3026094|Other||Difference in LS means|-2.29||||0.137|2-Sided|95.0|-5.35|0.78|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645069|NCT01798849|3026094|Other||Difference in LS means|-0.92||||0.554|2-Sided|95.0|-4.08|2.24|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645070|NCT01798849|3026094|Other||Difference in LS means|-0.65||||0.677|2-Sided|95.0|-3.81|2.52|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645071|NCT01798849|3026095|Other||Difference in LS means|9.14|||<|0.0001|2-Sided|95.0|6.98|11.3|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645072|NCT01798849|3026095|Other||Difference in LS means|2.33|||<|0.041|2-Sided|95.0|0.11|4.56|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645073|NCT01798849|3026095|Other||Difference in LS means|0.72|||<|0.616|2-Sided|95.0|-2.2|3.63|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645074|NCT01798849|3026095|Other||Difference in LS means|0.54|||<|0.638|2-Sided|95.0|-1.8|2.87|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645075|NCT01798849|3026096|Other||Difference in LS means|-8.28|||<|0.0001|2-Sided|95.0|-11.32|-5.25|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645076|NCT01798849|3026096|Other||Difference in LS means|-6.42|||<|0.0001|2-Sided|95.0|-8.94|-3.89|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645077|NCT01798849|3026096|Other||Difference in LS means|-3.29|||<|0.01|2-Sided|95.0|-5.71|-0.88|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645078|NCT01798849|3026096|Other||Difference in LS means|-2.53|||<|0.042|2-Sided|95.0|-4.97|-0.1|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645079|NCT01798849|3026097|Other||Difference in LS means|-4.74||||0.001|2-Sided|95.0|-7.37|-2.11|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645080|NCT01798849|3026097|Other||Difference in LS means|-1.77||||0.201|2-Sided|95.0|-4.51|0.98|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645081|NCT01798849|3026097|Other||Difference in LS means|-3.77||||0.008|2-Sided|95.0|-6.48|-1.06|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645082|NCT01798849|3026097|Other||Mixed effect model|-4.15||||0.002|2-Sided|95.0|-6.74|-1.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.||
1645083|NCT01798849|3026097|Other||Difference in LS means|-0.19||||0.901|2-Sided|95.0|-3.22|2.84|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645084|NCT01798849|3026097|Other||Difference in LS means|-2.75||||0.043|2-Sided|95.0|-5.4|-0.09|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645085|NCT01798849|3026097|Other||Difference in LS means|-2.23||||0.115|2-Sided|95.0|-5.03|0.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645086|NCT01798849|3026097|Other||Difference in LS means|-1.66||||0.202|2-Sided|95.0|-4.24|0.93|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645159|NCT01797965|3026202|Superiority|||||||0.7003|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change to Week 144|
1645087|NCT01798849|3026098|Other||Difference in LS means|14.05|||<|0.0001|2-Sided|95.0|10.54|17.57|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645088|NCT01798849|3026098|Other||Difference in LS means|8.11|||<|0.0001|2-Sided|95.0|5.45|10.76|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645089|NCT01798849|3026098|Other||Difference in LS means|6.62|||<|0.002|2-Sided|95.0|2.54|10.71|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645090|NCT01798849|3026098|Other||Difference in LS means|7.06|||<|0.001|2-Sided|95.0|3.03|11.1|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645091|NCT01798849|3026098|Other||Difference in LS means|5.21|||<|0.007|2-Sided|95.0|1.51|8.92|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645092|NCT01798849|3026098|Other||Difference in LS means|2.48|||<|0.016|2-Sided|95.0|0.49|4.47|||Mixed effect model||Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645093|NCT01798849|3026098|Other||Difference in LS means|3.32|||<|0.05|2-Sided|95.0|0.0|6.64|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645094|NCT01798849|3026098|Other||Difference in LS means|-1.77|||<|0.212|2-Sided|95.0|-4.59|1.05|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645095|NCT01798849|3026099|Other||Difference in LS means|-8.22|||<|0.0001|2-Sided|95.0|-11.95|-4.5|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645096|NCT01798849|3026099|Other||Difference in LS means|-5.68|||<|0.0001|2-Sided|95.0|-6.7|-4.65|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645097|NCT01798849|3026099|Other||Difference in LS means|-5.37|||<|0.0001|2-Sided|95.0|-7.29|-3.46|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645098|NCT01798849|3026099|Other||Difference in LS means|-4.89|||<|0.0001|2-Sided|95.0|-6.4|-3.37|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645099|NCT01798849|3026099|Other||Difference in LS means|-2.84|||<|0.036|2-Sided|95.0|-5.48|-0.19|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645100|NCT01798849|3026099|Other||Difference in LS means|-2.03|||<|0.07|2-Sided|95.0|-4.23|0.17|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645101|NCT01798849|3026099|Other||Difference in LS means|-0.76|||<|0.305|2-Sided|95.0|-2.24|0.72|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645102|NCT01798849|3026099|Other||Difference in LS means|-2.67|||<|0.128|2-Sided|95.0|-6.14|0.8|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645103|NCT01798849|3026100|Other||Difference in LS means|-6.63|||<|0.0001|2-Sided|95.0|-9.35|-3.92|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645104|NCT01798849|3026100|Other||Difference in LS means|-6.32|||<|0|2-Sided|95.0|-9.55|-3.1|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645105|NCT01798849|3026100|Other||Difference in LS means|-3.53|||<|0.038|2-Sided|95.0|-6.86|-0.21|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645106|NCT01798849|3026100|Other||Difference in LS means|-2.34|||<|0.165|2-Sided|95.0|-5.7|1.02|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645107|NCT01798849|3026103|Other||Difference in LS means|-7.56|||<|0.0001|2-Sided|95.0|-10.5|-4.63|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645108|NCT01798849|3026103|Other||Difference in LS means|-5.61|||<|0.001|2-Sided|95.0|-8.62|-2.6|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645109|NCT01798849|3026103|Other||Difference in LS means|-5.31|||<|0.001|2-Sided|95.0|-8.32|-2.31|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645110|NCT01798849|3026103|Other||Difference in LS means|-4.89|||<|0.002|2-Sided|95.0|-7.79|-1.99|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645111|NCT01798849|3026103|Other||Difference in LS means|-2.92|||<|0.063|2-Sided|95.0|-6.0|0.17|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645112|NCT01798849|3026103|Other||Difference in LS Means|-2.88|||<|0.056|2-Sided|95.0|-5.83|0.08|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645113|NCT01798849|3026103|Other||Difference in LS means|-0.94|||<|0.531|2-Sided|95.0|-3.94|2.06|||Mixed effects model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645114|NCT01798849|3026103|Other||Difference in Least-square (LS) Means|-0.5|||<|0.732|2-Sided|95.0|-3.42|2.43|||Mixed effect model|Mixed effects model for each cohort containing fixed effects for Day 1 predose and treatment and a random effect for participant.|Difference in LS means = LS mean MK-8892 minus LS mean placebo||
1645115|NCT01798706|3026112|Superiority or Other||LS Mean Difference|-0.31|Standard Error of the Mean|0.262||0.2347|2-Sided|95.0|-0.828|0.204||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to <60, ≥60 ml/min/1.73 m^2), and country as fixed effects and baseline FPG value as a covariate.|
1645116|NCT01798706|3026113|Superiority or Other||LS Mean Difference|-1.32|Standard Error of the Mean|0.278|<|0.0001|2-Sided|95.0|-1.862|-0.769||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to <60, ≥60 ml/min/1.73 m^2), and country as fixed effects and baseline body weight value as a covariate.|
1645117|NCT01798706|3026114|Superiority or Other||LS Mean Difference|-0.96|Standard Error of the Mean|0.219|<|0.0001|2-Sided|95.0|-1.39|-0.527||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to <60, ≥60 ml/min/1.73 m^2), and country as fixed effects and baseline 7-point SMPG value as a covariate.|
1645118|NCT01798706|3026115|Superiority or Other||LS Mean Difference|-5.05|Standard Error of the Mean|0.464|<|0.0001|2-Sided|95.0|-5.96|-4.132||Threshold for significance at 0.05 level. Testing sequence continued only when previous endpoint was statistically significant at 0.05.|ANCOVA||Lixisenatide vs Placebo|Analysis was performed using ANCOVA model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 eGFR (≥30 to <60, ≥60 ml/min/1.73 m^2), and country as fixed effects and baseline 2-hour PPG value as a covariate. Hierarchical testing procedure was used to control type I error at 0.05. Testing was then performed sequentially in the order the endpoints were reported.|
1645119|NCT01798706|3026116|Superiority or Other||Least Square (LS) Mean Difference|-0.64|Standard Error of the Mean|0.088|<|0.0001|2-Sided|95.0|-0.81|-0.464||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide vs Placebo|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of basal insulin use at screening, randomization strata of Week -1 glomerular filtration rate (eGFR) (≥30 to <60, ≥60 ml/min/1.73 m^2), and country as fixed effects and baseline HbA1c value as a covariate.|
1645120|NCT01798589|3026127|Other|Bioequivalence is assessed based on concordance between the 2 allergen using Kappa statistic|Concordance|66.7|||||2-Sided|95.0|41.6|90.2|||||||
1645121|NCT01798485|3026137|Superiority or Other|||||||0.25||||||Significance level of 0.05.|Fisher Exact||||
1645122|NCT01798485|3026138|Superiority or Other||Hazard Ratio (HR)|1.233||||0.1343|2-Sided|95.0|0.937|1.621||Significance level of 0.05.|Log Rank|Stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).|||
1645123|NCT01798485|3026141|Superiority or Other||Hazard Ratio (HR)|1.112||||0.5191|2-Sided|95.0|0.797|1.551||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening ECOG and geographic region).|||
1645124|NCT01798485|3026142|Superiority or Other||Hazard Ratio (HR)|2.344||||0.0111|2-Sided|95.0|1.207|4.551||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).|||
1645125|NCT01798485|3026143|Superiority or Other|||||||0.817||||||Significance level of 0.05.|Fisher Exact|||>= 12 weeks|
1645126|NCT01798485|3026143|Superiority or Other|||||||0.339||||||Significance level of 0.05.|Fisher Exact|||>= 6 weeks|
1645127|NCT01798485|3026144|Superiority or Other|||||||0.448||||||Significance level of 0.05.|Fisher Exact||||
1645128|NCT01798485|3026145|Superiority or Other||Hazard Ratio (HR)|1.232||||0.2506|2-Sided|95.0|0.865|1.754||Significance level of 0.05.|Log Rank|P-value was from stratified log-rank test (strata: screening ECOG and geographic region).|||
1645129|NCT01798485|3026146|Superiority or Other||Hazard Ratio (HR)|1.161||||0.118|2-Sided|95.0|0.961|1.403||Significance level of 0.05.|Log Rank|Stratified log-rank test with stratification variables, ECOG, screening total LDH levels, and geographic region, used to compare the treatment groups.|||
1645160|NCT01797965|3026202|Superiority|||||||0.5634|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change to Week 48|
1645161|NCT01797965|3026202|Superiority|||||||0.1679|||||||ANOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change to Week 24|
1645130|NCT01798485|3026147|Superiority or Other||Hazard Ratio (HR)|1.111|||||2-Sided|99.5|0.821|1.503||||||"Futility analysis for the first Interim Analysis which had a database cutoff of 19 October 2015. For the first interim analysis, if the lower limit of the 2-sided 99.5% confidence interval (CI) for the Hazard Ratio was greater than 0.75, then the study could be stopped for futility, based on Data Monitoring Committee recommendation.~Hazard ratio and 99.5% CI were calculated using the stratified Cox Proportional Hazards model (strata: screening LDH, screening ECOG and geographic region)."|
1645131|NCT01798485|3026147|Superiority or Other||Hazard Ratio (HR)|1.111||||0.3293|2-Sided|95.0|0.899|1.372|||Log Rank|P-value was from stratified log-rank test (strata: screening LDH, screening ECOG and geographic region).||Primary study hypothesis was tested at a 2-sided, 0.05 significance level using a stratified log-rank test.|
1645132|NCT01798316|3026161|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1645133|NCT01798056|3026189|Non-Inferiority|Criteria used: The lower limit (LL) of the 95% confidence interval (CI) of the Geometric Mean (GM) ratio (GSK1437173A PreChemo group over Placebo PreChemo group) in anti-gE ELISA antibody concentrations is greater than 3.|Adjusted GMC ratio|23.2|||||2-Sided|95.0|17.9|30.0||||||The analysis evaluated the anti-gE humoral immune responses at Month 2, following a two-dose administration of the GSK1437173A vaccine, as compared to placebo in subjects with solid tumours receiving chemotherapy (PreChemo Groups only).|
1645134|NCT01797965|3026201|Superiority|||||||0.6123|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 240 for 303|
1645135|NCT01797965|3026201|Superiority|||||||0.5159|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 216 for 303|
1645136|NCT01797965|3026201|Superiority|||||||0.259|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 192 for 303|
1645137|NCT01797965|3026201|Superiority|||||||0.8617|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 168 for 303|
1645138|NCT01797965|3026201|Superiority|||||||0.6001|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 303|
1645139|NCT01797965|3026201|Superiority|||||||0.5038|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 303|
1645140|NCT01797965|3026201|Superiority|||||||0.1669|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 303|
1645141|NCT01797965|3026201|Superiority|||||||0.5068|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 303|
1645142|NCT01797965|3026201|Superiority|||||||0.3945|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Baseline 303|
1645143|NCT01797965|3026201|Superiority|||||||0.2183|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 301|
1645144|NCT01797965|3026201|Superiority|||||||0.8647|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 132 for 301|
1645145|NCT01797965|3026201|Superiority|||||||0.7295|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 120 for 301|
1645146|NCT01797965|3026201|Superiority|||||||0.129|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 108 for 301|
1645147|NCT01797965|3026201|Superiority|||||||0.325|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 96 for 301|
1645148|NCT01797965|3026201|Superiority|||||||0.4478|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 84 for 301|
1645149|NCT01797965|3026201|Superiority|||||||0.8486|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 72 for 301|
1645150|NCT01797965|3026201|Superiority|||||||0.7962|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 60 for 301|
1645151|NCT01797965|3026201|Superiority|||||||0.9988|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 301|
1645152|NCT01797965|3026201|Superiority|||||||0.2024|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 36 for 301|
1645153|NCT01797965|3026201|Superiority|||||||0.6152|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 301|
1645154|NCT01797965|3026201|Superiority|||||||0.2567|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 301|
1645155|NCT01797965|3026202|Superiority|||||||0.0288|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change to Week 240|
1645156|NCT01797965|3026202|Superiority|||||||0.6423|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change to Week 216|
1645157|NCT01797965|3026202|Superiority|||||||0.3246|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change to Week 192|
1645158|NCT01797965|3026202|Superiority|||||||0.7812|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change to Week 168|
1645162|NCT01797965|3026202|Superiority|||||||0.3813|||||||ANCOVA|Based on ranks and adjusted for the baseline raw score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change to Week 12|
1645163|NCT01797965|3026224|Superiority||Odds Ratio (OR)|0.902||||0.8417|2-Sided|95.0|0.329|2.473|||Regression, Logistic|Adjusted for the baseline relapse rate, history of prior IFN beta use (yes/no), baseline EDSS (<=2.5 vs >2.5) and baseline age (<=35 vs >35).|||
1645164|NCT01797965|3026226|Superiority|||||||0.396|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 303|
1645165|NCT01797965|3026226|Superiority|||||||0.0057|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 303|
1645166|NCT01797965|3026226|Superiority|||||||0.0849|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 303|
1645167|NCT01797965|3026226|Superiority|||||||0.017|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Baseline 303|
1645168|NCT01797965|3026226|Superiority|||||||0.017|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 144 for 301|
1645169|NCT01797965|3026226|Superiority|||||||0.3619|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 132 for 301|
1645170|NCT01797965|3026226|Superiority|||||||0.2119|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 120 for 301|
1645171|NCT01797965|3026226|Superiority|||||||0.3195|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 108 for 301|
1645172|NCT01797965|3026226|Superiority|||||||0.0339|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 96 for 301|
1645173|NCT01797965|3026226|Superiority|||||||0.0431|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 84 for 301|
1645174|NCT01797965|3026226|Superiority|||||||0.8522|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 72 for 301|
1645175|NCT01797965|3026226|Superiority|||||||0.2302|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 60 for 301|
1645176|NCT01797965|3026226|Superiority|||||||0.4738|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 48 for 301|
1645177|NCT01797965|3026226|Superiority|||||||0.2535|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 36 for 301|
1645178|NCT01797965|3026226|Superiority|||||||0.0805|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 24 for 301|
1645179|NCT01797965|3026226|Superiority|||||||0.0204|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change from Baseline 301 to Week 12 for 301|
1645180|NCT01797965|3026227|Superiority|||||||0.1884|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change to Week 48|
1645181|NCT01797965|3026227|Superiority|||||||0.6233|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change to Week 24|
1645182|NCT01797965|3026227|Superiority|||||||0.5937|||||||ANCOVA|Based on ranks and adjusted for the baseline Z-score, baseline age (<=35 vs >35) and history of prior IFN beta.||Change to Week 12|
1645183|NCT01797822|3026246|Other|Statistical comparison between groups was made with t-test. A sample size of 20 subjects was calculates to have 90% power of detecting a statistical difference (P<0.05) in change in corneal staining pre and post low humidity challenge.|||||<|0.05|||||||t-test, 1 sided||||
1645184|NCT01797536|3026266|Superiority or Other||GMR|0.78|||||2-Sided|90.0|0.43|1.43|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values|
1645185|NCT01797536|3026266|Superiority or Other||GMR|0.69|||||2-Sided|90.0|0.38|1.25|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values|
1645186|NCT01797536|3026266|Superiority or Other||GMR|0.61|||||2-Sided|90.0|0.34|1.08|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values|
1645187|NCT01797536|3026267|Superiority or Other||GMR|0.58|||||2-Sided|90.0|0.32|1.08|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values|
1645188|NCT01797536|3026267|Superiority or Other||GMR|0.64|||||2-Sided|90.0|0.35|1.14|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values|
1645189|NCT01797536|3026267|Superiority or Other||GMR|0.58|||||2-Sided|90.0|0.32|1.05|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values|
1645190|NCT01797536|3026268|Superiority or Other||GMR|0.63|||||2-Sided|90.0|0.35|1.13|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values|
1645236|NCT01796236|3026402|Superiority or Other|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Week 24|
1645191|NCT01797536|3026268|Superiority or Other||GMR|0.64|||||2-Sided|90.0|0.35|1.14|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values|
1645192|NCT01797536|3026268|Superiority or Other||GMR|0.6|||||2-Sided|90.0|0.34|1.05|||||GMR = Mild Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values|
1645193|NCT01797536|3026269|Superiority or Other||GMR|0.88|||||2-Sided|90.0|0.48|1.61|||||GMR = Severe Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values|
1645194|NCT01797536|3026269|Superiority or Other||GMR|0.72|||||2-Sided|90.0|0.4|1.31|||||GMR = Moderate Hepatic Insufficiency GM divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values|
1645195|NCT01797536|3026269|Superiority or Other||Geometric Mean Ratio (GMR)|0.61|||||2-Sided|90.0|0.34|1.08|||||GMR= Mild Hepatic Insufficiency Geometric Mean (GM) divided by Healthy Control GM|Back-transformed least-squares mean and confidence interval from linear fixed effect model performed on natural log-transformed values|
1645196|NCT01797458|3026281|Superiority or Other|||||||0.02||||||Twenty-five teeth experienced at least one ‘Minor’ failure (reversible pulpitis, caries progression, and secondary caries): NRCT 9 (6.4%), CR 14 (10%), HT 2 (1.4%).|Kruskal-Wallis|||The null hypothesis was no difference at 2 yrs among any of the 3 arms for the primary outcome of success or minor failure.|
1645197|NCT01797445|3026298|Superiority or Other (legacy)||Difference in Percentages|3.1||||0.13|2-Sided|95.002|-1.0|7.1|||Cochran-Mantel-Haenszel|P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or > 100,000 copies/mL) and region (US vs ex-US).|The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.|Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was < 12% worse than the E/C/F/TDF group.|
1645198|NCT01797120|3026317|Superiority|||||||0.47|||||||Fisher Exact||||
1645199|NCT01797120|3026318|Superiority|||||||0.01|||||||Fisher Exact||||
1645200|NCT01797120|3026319|Superiority||Hazard Ratio (HR)|0.61||||0.02|2-Sided|95.0|0.4|0.92|||Log Rank|Log rank test was stratified on ECOG performance status, measurable disease, and prior chemotherapy for metastatic disease|||
1645201|NCT01797029|3026346|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1645202|NCT01796964|3026358|Non-Inferiority or Equivalence|Non-inferiority at week 16 is concluded at one-sided alpha level of 0.10 if the lower limit of the corresponding two-sided 80% confidence interval for the treatment difference (ESBA 1008 – EYLEA) is greater than -5 letters.|Treatment difference (ESBA - Eylea)|-0.58|||||2-Sided|80.0|-3.72|2.56|||||Treatment differences were based on least squares estimates.|An analysis of variance (ANOVA) model with treatment and baseline BCVA categories (< 55 and ≥ 55 letters) as class variables was used to estimate the treatment group differences (ESBA1008 - EYLEA) in the primary efficacy endpoint, BCVA Change from baseline to Week 16.|
1645203|NCT01796964|3026359|Non-Inferiority or Equivalence|Non-inferiority at week 12 is concluded at one-sided alpha level of 0.10 if the lower limit of the corresponding two-sided 80% confidence interval for the treatment difference (ESBA 1008 – EYLEA) is greater than -5 letters.|Treatment difference (ESBA - Eylea)|-1.13|||||2-Sided|80.0|-4.19|1.93|||||Treatment differences were based on least squares estimates.|An analysis of variance (ANOVA) model with treatment and baseline BCVA categories (< 55 and ≥ 55 letters) as class variables was used to estimate the treatment group differences (ESBA1008 – EYLEA) in the primary efficacy endpoint, BCVA Change from baseline to Week 12.|
1645204|NCT01796912|3026360|Superiority|||||||0.005|||||||Wilcoxon (Mann-Whitney)||||
1645205|NCT01796912|3026361|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1645206|NCT01796912|3026362|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1645207|NCT01796912|3026363|Superiority|||||||0.016|||||||t-test, 2 sided||||
1645208|NCT01796912|3026364|Superiority|||||||0.14|||||||t-test, 2 sided||||
1645209|NCT01796912|3026365|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1645210|NCT01796912|3026366|Superiority|||||||0.001|||||||t-test, 2 sided||||
1645211|NCT01796301|3026383|Superiority||Treatment difference|4.4|Standard Error of the Mean|0.5|<|0.0001|2-Sided|95.0|3.4|5.4|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.|
1645212|NCT01796301|3026384|Superiority||Treatment difference|3.8|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|2.9|4.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.|
1645213|NCT01796301|3026385|Superiority||Treatment difference|3.4|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|2.6|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.|
1645214|NCT01796301|3026386|Superiority||Treatment difference|3.2|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|2.5|3.9|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.|
1645215|NCT01796301|3026387|Superiority||Treatment difference|3.6|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|2.9|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.|
1645216|NCT01796301|3026388|Superiority||Treatment difference|3.1|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|2.6|3.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.|
1645217|NCT01796301|3026389|Superiority||Treatment difference|3.2|Standard Error of the Mean|0.6|<|0.0001|2-Sided|95.0|2.1|4.3|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.|
1645218|NCT01796301|3026390|Superiority||Treatment difference|3.1|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|2.4|3.8|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.|
1645219|NCT01796301|3026391|Superiority||Treatment difference|3.6|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|2.9|4.2|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.|
1645220|NCT01796301|3026392|Superiority||Treatment difference|3.1|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|2.5|3.6|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.|
1645221|NCT01796301|3026393|Superiority||Treatment difference|4.6|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|3.9|5.3|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.|
1645222|NCT01796301|3026394|Superiority||Treatment difference|3.4|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|2.8|4.0|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, parameter baseline value, treatment-by visit interaction, and using an unstructured variance covariance structure.|
1645223|NCT01796301|3026395|Superiority||Treatment difference|3.4|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|2.8|4.0|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.|
1645224|NCT01796301|3026396|Superiority||Treatment difference|3.1|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|2.5|3.7|||Linear mixed effects repeated measures|||Treatment difference (Romosozumab – Teriparatide) was analyzed using a linear mixed effects model for repeated measures adjusting for treatment, visit, baseline serum type 1 collagen C-telopeptide value, baseline BMD value, machine type, baseline BMD value-by machine type interaction, treatment-by-visit interaction, and using an unstructured variance covariance structure.|
1645225|NCT01796301|3026397|Superiority|A two-step, step-down, fixed-sequential testing procedure was used to test the primary and key secondary efficacy endpoints for the comparison of romosozumab to teriparatide in the order presented for multiplicity adjustment to maintain the overall significance level at 0.05. The Key Secondary Efficacy Endpoints are the first 8 secondary endpoints reported below.|Treatment difference|3.2|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|2.7|3.8|||Linear mixed effects repeated measures|||The primary analysis to assess the treatment difference (Romosozumab – Teriparatide) employed a linear mixed effects model for repeated measures. The model included main effects for treatment group, visit (categorical), baseline sCTX, baseline hip DXA BMD value, machine type (categorical), and machine type-by-baseline value interaction (to adjust for the effect of machine type on baseline DXA BMD value) as fixed main effects using an unstructured within-subject variance-covariance structure.|
1645226|NCT01796236|3026399|Superiority or Other||Hazard Ratio (HR)|0.98||||0.989|2-Sided|95.0|||||Log Rank|||Loss of Implant (safety population)|
1645227|NCT01796236|3026400|Superiority or Other|||||||0.45|||||||Mantel Haenszel|||Month 36: Smoking and Wet Snuff habits|
1645228|NCT01796236|3026400|Superiority or Other|||||||0.19|||||||Mantel Haenszel|||Month 24: Smoking and Wet Snuff habits|
1645229|NCT01796236|3026400|Superiority or Other|||||||0.22|||||||Mantel Haenszel|||Month 12: Smoking and Wet Snuff habits|
1645230|NCT01796236|3026400|Superiority or Other|||||||0.95|||||||Mantel Haenszel|||Week 12: Smoking and Wet Snuff habits|
1645231|NCT01796236|3026400|Superiority or Other|||||||0.7|||||||Mantel Haenszel|||Week 3: Smoking and Wet Snuff habits|
1645232|NCT01796236|3026400|Superiority or Other|||||||0.91|||||||Mantel Haenszel|||Baseline: Smoking and Wet Snuff habits|
1645233|NCT01796236|3026402|Superiority or Other|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 36|
1645234|NCT01796236|3026402|Superiority or Other|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 24|
1645235|NCT01796236|3026402|Superiority or Other|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Use of Sound Processor: Month 12|
1645238|NCT01796236|3026402|Superiority or Other|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||Sound Processor Usage: Week 6|
1645239|NCT01796236|3026403|Superiority or Other|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Benefit)|
1645240|NCT01796236|3026403|Superiority or Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Benefit)|
1645241|NCT01796236|3026403|Superiority or Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Benefit)|
1645242|NCT01796236|3026403|Superiority or Other|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Benefit)|
1645243|NCT01796236|3026403|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Benefit)|
1645244|NCT01796236|3026403|Superiority or Other|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Unaided)|
1645245|NCT01796236|3026403|Superiority or Other|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Unaided)|
1645246|NCT01796236|3026403|Superiority or Other|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Unaided)|
1645247|NCT01796236|3026403|Superiority or Other|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Unaided)|
1645248|NCT01796236|3026403|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Unaided)|
1645249|NCT01796236|3026403|Superiority or Other|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Month 36: Global (Aided)|
1645250|NCT01796236|3026403|Superiority or Other|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Month 36: Aversiveness (Aided)|
1645251|NCT01796236|3026403|Superiority or Other|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Month 36: Reverberation (Aided)|
1645252|NCT01796236|3026403|Superiority or Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 36: Background Noise (Aided)|
1645253|NCT01796236|3026403|Superiority or Other|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ease of Communication (Aided)|
1645254|NCT01796236|3026403|Superiority or Other|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Benefit)|
1645255|NCT01796236|3026403|Superiority or Other|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Benefit)|
1645256|NCT01796236|3026403|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Benefit)|
1645257|NCT01796236|3026403|Superiority or Other|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Benefit)|
1645258|NCT01796236|3026403|Superiority or Other|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Benefit)|
1645259|NCT01796236|3026403|Superiority or Other|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Unaided)|
1645260|NCT01796236|3026403|Superiority or Other|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Unaided)|
1645261|NCT01796236|3026403|Superiority or Other|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Unaided)|
1645262|NCT01796236|3026403|Superiority or Other|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Unaided)|
1645263|NCT01796236|3026403|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Unaided)|
1645264|NCT01796236|3026403|Superiority or Other|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Month 12: Global (Aided)|
1645265|NCT01796236|3026403|Superiority or Other|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Month 12: Aversiveness (Aided)|
1645266|NCT01796236|3026403|Superiority or Other|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||Month 12: Reverberation (Aided)|
1645267|NCT01796236|3026403|Superiority or Other|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Month 12: Background Noise (Aided)|
1645268|NCT01796236|3026403|Superiority or Other|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ease of Communication (Aided)|
1645269|NCT01796236|3026403|Superiority or Other|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Benefit)|
1645270|NCT01796236|3026403|Superiority or Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Benefit)|
1645271|NCT01796236|3026403|Superiority or Other|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Benefit)|
1645272|NCT01796236|3026403|Superiority or Other|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Benefit)|
1645273|NCT01796236|3026403|Superiority or Other|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Benefit)|
1645274|NCT01796236|3026403|Superiority or Other|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Unaided)|
1645275|NCT01796236|3026403|Superiority or Other|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Unaided)|
1645276|NCT01796236|3026403|Superiority or Other|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Unaided)|
1645277|NCT01796236|3026403|Superiority or Other|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Unaided)|
1645278|NCT01796236|3026403|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Unaided)|
1645279|NCT01796236|3026403|Superiority or Other|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Week 24: Global (Aided)|
1645280|NCT01796236|3026403|Superiority or Other|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Week 24: Aversiveness (Aided)|
1645281|NCT01796236|3026403|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Week 24: Reverberation (Aided)|
1645282|NCT01796236|3026403|Superiority or Other|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Week 24: Background Noise (Aided)|
1645283|NCT01796236|3026403|Superiority or Other|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ease of Communication (Aided)|
1645284|NCT01796236|3026403|Superiority or Other|||||||0.042|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Benefit)|
1645285|NCT01796236|3026403|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Benefit)|
1645286|NCT01796236|3026403|Superiority or Other|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Benefit)|
1645287|NCT01796236|3026403|Superiority or Other|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Benefit)|
1645288|NCT01796236|3026403|Superiority or Other|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Benefit)|
1645289|NCT01796236|3026403|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Unaided)|
1645290|NCT01796236|3026403|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Unaided)|
1645291|NCT01796236|3026403|Superiority or Other|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Unaided)|
1645292|NCT01796236|3026403|Superiority or Other|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Unaided)|
1645293|NCT01796236|3026403|Superiority or Other|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Unaided)|
1645294|NCT01796236|3026403|Superiority or Other|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Baseline: Global (Aided)|
1645295|NCT01796236|3026403|Superiority or Other|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Baseline: Aversiveness (Aided)|
1645296|NCT01796236|3026403|Superiority or Other|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Baseline: Reverberation (Aided)|
1645297|NCT01796236|3026403|Superiority or Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Baseline: Background Noise (Aided)|
1645298|NCT01796236|3026403|Superiority or Other|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ease of Communication (Aided)|
1645299|NCT01796236|3026404|Superiority or Other|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain (HUI2)|
1645300|NCT01796236|3026404|Superiority or Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain (HUI2)|
1645301|NCT01796236|3026404|Superiority or Other|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||Week 24: Pain (HUI2)|
1645302|NCT01796236|3026404|Superiority or Other|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Baseline: Pain (HUI2)|
1645303|NCT01796236|3026404|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Self Care (HUI2)|
1645304|NCT01796236|3026404|Superiority or Other|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Month 12: Self Care (HUI2)|
1645305|NCT01796236|3026404|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|||Week 24: Self Care (HUI2)|
1645306|NCT01796236|3026404|Superiority or Other|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||Baseline: Self Care (HUI2)|
1645307|NCT01796236|3026404|Superiority or Other|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Month 36: Cognition (HUI2)|
1645308|NCT01796236|3026404|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 12: Cognition (HUI2)|
1645309|NCT01796236|3026404|Superiority or Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Week 24: Cognition (HUI2)|
1645310|NCT01796236|3026404|Superiority or Other|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Baseline: Cognition (HUI2)|
1645311|NCT01796236|3026404|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Month 36: Emotion (HUI2)|
1645312|NCT01796236|3026404|Superiority or Other|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Month 12: Emotion (HUI2)|
1645313|NCT01796236|3026404|Superiority or Other|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Week 24: Emotion (HUI2)|
1645314|NCT01796236|3026404|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Baseline: Emotion (HUI2)|
1645315|NCT01796236|3026404|Superiority or Other|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Month 36: Mobility (HUI2)|
1645316|NCT01796236|3026404|Superiority or Other|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Month 12: Mobility (HUI2)|
1645317|NCT01796236|3026404|Superiority or Other|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Week 24: Mobility (HUI2)|
1645318|NCT01796236|3026404|Superiority or Other|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Baseline: Mobility (HUI2)|
1645319|NCT01796236|3026404|Superiority or Other|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Sensation (HUI2)|
1645320|NCT01796236|3026404|Superiority or Other|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Month 12: Sensation (HUI2)|
1645321|NCT01796236|3026404|Superiority or Other|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Week 24: Sensation (HUI2)|
1645322|NCT01796236|3026404|Superiority or Other|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Baseline: Sensation (HUI2)|
1645323|NCT01796236|3026404|Superiority or Other|||||||0.0084|||||||Wilcoxon (Mann-Whitney)|||Month 36: Comprehensive Health State (HUI2)|
1645324|NCT01796236|3026404|Superiority or Other|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Month 12: Comprehensive Health State (HUI2)|
1645325|NCT01796236|3026404|Superiority or Other|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Week 24: Comprehensive Health State (HUI2)|
1645326|NCT01796236|3026404|Superiority or Other|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Baseline: Comprehensive Health State (HUI2)|
1645327|NCT01796236|3026404|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain (HUI3)|
1645328|NCT01796236|3026404|Superiority or Other|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain (HUI3)|
1645329|NCT01796236|3026404|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Week 24: Pain (HUI3)|
1645330|NCT01796236|3026404|Superiority or Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Baseline: Pain (HUI3)|
1645331|NCT01796236|3026404|Superiority or Other|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36: Cognition (HUI3)|
1645332|NCT01796236|3026404|Superiority or Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Month 12: Cognition (HUI3)|
1645333|NCT01796236|3026404|Superiority or Other|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Week 24: Cognition (HUI3)|
1645334|NCT01796236|3026404|Superiority or Other|||||||0.95|||||||Wilcoxon (Mann-Whitney)|||Baseline: Cognition (HUI3)|
1645335|NCT01796236|3026404|Superiority or Other|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Month 36: Emotion (HUI3)|
1645336|NCT01796236|3026404|Superiority or Other|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Month 12: Emotion (HUI3)|
1645337|NCT01796236|3026404|Superiority or Other|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Week 24: Emotion (HUI3)|
1645338|NCT01796236|3026404|Superiority or Other|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Baseline: Emotion (HUI3)|
1645339|NCT01796236|3026404|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Month 36: Ambulation (HUI3)|
1645340|NCT01796236|3026404|Superiority or Other|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 12: Ambulation (HUI3)|
1645341|NCT01796236|3026404|Superiority or Other|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Week 24: Ambulation (HUI3)|
1645342|NCT01796236|3026404|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Baseline: Ambulation (HUI3)|
1645343|NCT01796236|3026404|Superiority or Other|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||Month 36: Speech (HUI3)|
1645344|NCT01796236|3026404|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|||Month 12: Speech (HUI3)|
1645345|NCT01796236|3026404|Superiority or Other|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Week 24: Speech (HUI3)|
1645346|NCT01796236|3026404|Superiority or Other|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Baseline: Speech (HUI3)|
1645347|NCT01796236|3026404|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 36: Hearing (HUI3)|
1645348|NCT01796236|3026404|Superiority or Other|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Month 12: Hearing (HUI3)|
1645349|NCT01796236|3026404|Superiority or Other|||||||0.059|||||||Wilcoxon (Mann-Whitney)|||Week 24: Hearing (HUI3)|
1645350|NCT01796236|3026404|Superiority or Other|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Baseline: Hearing (HUI3)|
1645351|NCT01796236|3026404|Superiority or Other|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Month 36: Vision (HUI3)|
1645352|NCT01796236|3026404|Superiority or Other|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||Month 12: Vision (HUI3)|
1645353|NCT01796236|3026404|Superiority or Other|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Week 24: Vision (HUI3)|
1645354|NCT01796236|3026404|Superiority or Other|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Baseline: Vision (HUI3)|
1645355|NCT01796236|3026404|Superiority or Other|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Month 36: Comprehensive Health State (HUI3)|
1645356|NCT01796236|3026404|Superiority or Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 12: Comprehensive Health State (HUI3)|
1645357|NCT01796236|3026404|Superiority or Other|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 24: Comprehensive Health State (HUI3)|
1645358|NCT01796236|3026404|Superiority or Other|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Baseline: Comprehensive Health State (HUI3)|
1645359|NCT01796236|3026405|Superiority or Other|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pain not within Scar (patient)|
1645360|NCT01796236|3026405|Superiority or Other|||||||0.053|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pain not within Scar (patient)|
1645361|NCT01796236|3026405|Superiority or Other|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pain not within Scar (patient)|
1645362|NCT01796236|3026405|Superiority or Other|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Month 36: Overall Opinion (patient)|
1645363|NCT01796236|3026405|Superiority or Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (patient)|
1645364|NCT01796236|3026405|Superiority or Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (patient)|
1645365|NCT01796236|3026405|Superiority or Other|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36: Total Score (patient)|
1645366|NCT01796236|3026405|Superiority or Other|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Month 12: Total Score (patient)|
1645367|NCT01796236|3026405|Superiority or Other|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Week 12: Total Score (patient)|
1645368|NCT01796236|3026405|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Month 36: Irregularity (patient)|
1645369|NCT01796236|3026405|Superiority or Other|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Month 12: Irregularity (patient)|
1645370|NCT01796236|3026405|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Week 12: Irregularity (patient)|
1645371|NCT01796236|3026405|Superiority or Other|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Month 36: Thickness (patient)|
1645372|NCT01796236|3026405|Superiority or Other|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Month 12: Thickness (patient)|
1645373|NCT01796236|3026405|Superiority or Other|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Week 12: Thickness (patient)|
1645374|NCT01796236|3026405|Superiority or Other|||||||0.017|||||||Wilcoxon (Mann-Whitney)|||Month 36: Stiffness (patient)|
1645375|NCT01796236|3026405|Superiority or Other|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Month 12: Stiffness (patient)|
1645376|NCT01796236|3026405|Superiority or Other|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 12: Stiffness (patient)|
1645377|NCT01796236|3026405|Superiority or Other|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 36: Color (patient)|
1645378|NCT01796236|3026405|Superiority or Other|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Month 12: Color (patient)|
1645379|NCT01796236|3026405|Superiority or Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Week 12: Color (patient)|
1645380|NCT01796236|3026405|Superiority or Other|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Month 36: Itching (patient)|
1645381|NCT01796236|3026405|Superiority or Other|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Month 12: Itching (patient)|
1645382|NCT01796236|3026405|Superiority or Other|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Week 12: Itching (patient)|
1645383|NCT01796236|3026405|Superiority or Other|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Month 36: Painful (patient)|
1645384|NCT01796236|3026405|Superiority or Other|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Month 12: Painful (patient)|
1645385|NCT01796236|3026405|Superiority or Other|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Week 12: Painful (patient)|
1645386|NCT01796236|3026405|Superiority or Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Month 36: Overall Opinion (observer)|
1645387|NCT01796236|3026405|Superiority or Other|||||||0.076|||||||Wilcoxon (Mann-Whitney)|||Month 12: Overall Opinion (observer)|
1645388|NCT01796236|3026405|Superiority or Other|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||Week 12: Overall Opinion (observer)|
1645389|NCT01796236|3026405|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Month 36: Total Score (observer)|
1645390|NCT01796236|3026405|Superiority or Other|||||||0.085|||||||Wilcoxon (Mann-Whitney)|||Month 12: Total Score (observer)|
1645391|NCT01796236|3026405|Superiority or Other|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||Week 12: Total Score (observer)|
1645392|NCT01796236|3026405|Superiority or Other|||||||0.045|||||||Wilcoxon (Mann-Whitney)|||Month 36: Surface Area (observer)|
1645393|NCT01796236|3026405|Superiority or Other|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Month 12: Surface Area (observer)|
1645394|NCT01796236|3026405|Superiority or Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||Week 12: Surface Area (observer)|
1645395|NCT01796236|3026405|Superiority or Other|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pliability (observer)|
1645396|NCT01796236|3026405|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pliability (observer)|
1645397|NCT01796236|3026405|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pliability (observer)|
1645398|NCT01796236|3026405|Superiority or Other|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||Month 36: Relief (observer)|
1645399|NCT01796236|3026405|Superiority or Other|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||Month 12: Relief (observer)|
1645400|NCT01796236|3026405|Superiority or Other|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Week 12: Relief (observer)|
1645401|NCT01796236|3026405|Superiority or Other|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Month 36: Thickness (observer)|
1645402|NCT01796236|3026405|Superiority or Other|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||Month 12: Thickness (observer)|
1645403|NCT01796236|3026405|Superiority or Other|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||Week 12: Thickness (observer)|
1645404|NCT01796236|3026405|Superiority or Other|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Month 36: Pigmentation (observer)|
1645405|NCT01796236|3026405|Superiority or Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Month 12: Pigmentation (observer)|
1645406|NCT01796236|3026405|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Week 12: Pigmentation (observer)|
1645407|NCT01796236|3026405|Superiority or Other|||||||0.094|||||||Wilcoxon (Mann-Whitney)|||Month 36: Vascularity (observer)|
1645408|NCT01796236|3026405|Superiority or Other|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Month 12: Vascularity (observer)|
1645409|NCT01796236|3026405|Superiority or Other|||||||0.026|||||||Wilcoxon (Mann-Whitney)|||Week 12: Vascularity (observer)|
1645410|NCT01796236|3026406|Superiority or Other|||||||0.0005|||||||Sign test|||Change in Visible Control Abutment - Month 36 change from day 10|
1645411|NCT01796236|3026406|Superiority or Other|||||||0.0021|||||||Sign test|||Change in Visible Control Abutment - Month 24 change from day 10|
1645412|NCT01796236|3026406|Superiority or Other|||||||0.0086|||||||Sign test|||Change in Visible Control Abutment - Month 12 change from day 10|
1645413|NCT01796236|3026406|Superiority or Other|||||||0.01|||||||Sign test|||Change in Visible Control Abutment - Week 24 change from day 10|
1645414|NCT01796236|3026406|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in Visible Control Abutment - Week 12 change from day 10|
1645415|NCT01796236|3026406|Superiority or Other||||||<|0.034|||||||Sign test|||Change in Visible Control Abutment - Week 6 change from day 10|
1645416|NCT01796236|3026406|Superiority or Other||||||<|0.072|||||||Sign test|||Change in Visible Control Abutment - Week 3 change from day 10|
1645417|NCT01796236|3026406|Superiority or Other||||||<|0.037|||||||Sign test|||Change in Visible Test Abutment - Month 36 change from day 10|
1645418|NCT01796236|3026406|Superiority or Other||||||<|0.028|||||||Sign test|||Change in Visible Test Abutment - Month 24 change from day 10|
1645419|NCT01796236|3026406|Superiority or Other||||||<|0.0003|||||||Sign test|||Change in Visible Test Abutment - Month 12 change from day 10|
1645420|NCT01796236|3026406|Superiority or Other||||||<|0.0065|||||||Sign test|||Change in Visible Test Abutment - Week 24 change from day 10|
1645421|NCT01796236|3026406|Superiority or Other||||||<|0.041|||||||Sign test|||Change in Visible Test Abutment - Week 12 change from day 10|
1645422|NCT01796236|3026406|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in Visible Test Abutment - Week 6 change from day 10|
1645423|NCT01796236|3026406|Superiority or Other||||||<|0.74|||||||Sign test|||Change in Visible Test Abutment - Week 3 change from day 10|
1645424|NCT01796236|3026406|Superiority or Other||||||<|0.32|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 36|
1645425|NCT01796236|3026406|Superiority or Other||||||<|0.15|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 24|
1645426|NCT01796236|3026406|Superiority or Other||||||<|0.017|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Month 12|
1645427|NCT01796236|3026406|Superiority or Other||||||<|0.18|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 24|
1645428|NCT01796236|3026406|Superiority or Other||||||<|0.45|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 12|
1645429|NCT01796236|3026406|Superiority or Other||||||<|0.46|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 6|
1645430|NCT01796236|3026406|Superiority or Other||||||<|0.008|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Week 3|
1645431|NCT01796236|3026406|Superiority or Other||||||<|0.0009|||||||Wilcoxon (Mann-Whitney)|||Visible Abutment Length Day 10|
1645432|NCT01796236|3026407|Superiority or Other|||||||1|||||||Mantel Haenszel|||Month 36 Soft tissue thickening/overgrowth|
1645433|NCT01796236|3026407|Superiority or Other|||||||0.81|||||||Mantel Haenszel|||Month 24 Soft tissue thickening/overgrowth|
1645434|NCT01796236|3026407|Superiority or Other|||||||0.63|||||||Mantel Haenszel|||Month 12 Soft tissue thickening/overgrowth|
1645435|NCT01796236|3026407|Superiority or Other|||||||0.18|||||||Mantel Haenszel|||Week 24 Soft tissue thickening/overgrowth|
1645436|NCT01796236|3026407|Superiority or Other|||||||0.53|||||||Mantel Haenszel|||Week 12 Soft tissue thickening/overgrowth|
1645437|NCT01796236|3026407|Superiority or Other|||||||0.84|||||||Mantel Haenszel|||Week 6 Soft tissue thickening/overgrowth|
1645438|NCT01796236|3026407|Superiority or Other|||||||0.016|||||||Mantel Haenszel|||Week 3 Soft tissue thickening/overgrowth|
1645439|NCT01796236|3026407|Superiority or Other|||||||0.12|||||||Mantel Haenszel|||Day 10 Soft tissue thickening/overgrowth|
1645440|NCT01796236|3026408|Superiority or Other|||||||0.77|||||||Cochran-Mantel-Haenszel|||Month 36 Scar pain|
1645441|NCT01796236|3026408|Superiority or Other|||||||0.19|||||||Cochran-Mantel-Haenszel|||Month 36 Neuropathic pain|
1645442|NCT01796236|3026408|Superiority or Other|||||||0.82|||||||Cochran-Mantel-Haenszel|||Month 12 Scar pain|
1645443|NCT01796236|3026408|Superiority or Other|||||||0.21|||||||Cochran-Mantel-Haenszel|||Month 12 Neuropathic pain|
1645444|NCT01796236|3026408|Superiority or Other|||||||0.33|||||||Cochran-Mantel-Haenszel|||Week 24: Scar pain|
1645445|NCT01796236|3026408|Superiority or Other|||||||0.43|||||||Cochran-Mantel-Haenszel|||Week 24: Neuropathic pain|
1645446|NCT01796236|3026408|Superiority or Other|||||||0.84|||||||Cochran-Mantel-Haenszel|||Week 12: Scar pain|
1645447|NCT01796236|3026408|Superiority or Other|||||||0.0087|||||||Cochran-Mantel-Haenszel|||Week 12: Neuropathic pain|
1645448|NCT01796236|3026408|Superiority or Other|||||||0.44|||||||Cochran-Mantel-Haenszel|||Week 6: Scar pain|
1645449|NCT01796236|3026408|Superiority or Other|||||||0.17|||||||Cochran-Mantel-Haenszel|||Week 6: Neuropathic pain|
1645450|NCT01796236|3026408|Superiority or Other|||||||0.59|||||||Cochran-Mantel-Haenszel|||Week 3: Scar pain|
1645451|NCT01796236|3026408|Superiority or Other|||||||0.14|||||||Cochran-Mantel-Haenszel|||Week 3: Neuropathic pain|
1645452|NCT01796236|3026408|Superiority or Other|||||||0.44|||||||Cochran-Mantel-Haenszel|||Day 10: Scar pain|
1645453|NCT01796236|3026408|Superiority or Other|||||||0.52|||||||Cochran-Mantel-Haenszel|||Day 10: Neuropathic pain|
1645454|NCT01796236|3026409|Superiority or Other|||||||0.71|||||||Mantel Haenszel|||Scar Categorical Max Pain 36 months|
1645455|NCT01796236|3026409|Superiority or Other|||||||0.076|||||||Mantel Haenszel|||Neuropathic Categorical Max Pain 36 months|
1645456|NCT01796236|3026410|Superiority or Other|||||||0.49|||||||Mantel Haenszel|||Scar Categorical Max Pain|
1645457|NCT01796236|3026410|Superiority or Other|||||||0.076|||||||Mantel Haenszel|||Neuropathic Categorical Max Pain|
1645458|NCT01796236|3026411|Superiority or Other|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Month 36, Scar pain|
1645459|NCT01796236|3026411|Superiority or Other|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||Month 36, Neuropathic pain|
1645460|NCT01796236|3026411|Superiority or Other|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Month 12, Scar pain|
1645461|NCT01796236|3026411|Superiority or Other|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Month 12, Neuropathic pain|
1645462|NCT01796236|3026411|Superiority or Other|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||Week 24, Scar pain|
1645463|NCT01796236|3026411|Superiority or Other|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Week 24, Neuropathic pain|
1645464|NCT01796236|3026411|Superiority or Other|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Week 12, Scar pain|
1645465|NCT01796236|3026411|Superiority or Other|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Week 12, Neuropathic pain|
1645466|NCT01796236|3026411|Superiority or Other|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Week 6, Scar pain|
1645467|NCT01796236|3026411|Superiority or Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Week 6, Neuropathic pain|
1645468|NCT01796236|3026411|Superiority or Other|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Week 3, Scar pain|
1645469|NCT01796236|3026411|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Week 3, Neuropathic pain|
1645470|NCT01796236|3026411|Superiority or Other|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Day 10, Scar pain|
1645471|NCT01796236|3026411|Superiority or Other|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Day 10, Neuropathic pain|
1645472|NCT01796236|3026412|Superiority or Other||||||<|0.0001|||||||Mantel Haenszel|||maximum numbness at 36 months|
1645473|NCT01796236|3026412|Superiority or Other||||||<|0.0001|||||||Mantel Haenszel|||maximum numbness at 12 months|
1645474|NCT01796236|3026413|Superiority or Other|||||||0.75|||||||Mantel Haenszel|||Holgers Index Month 36|
1645475|NCT01796236|3026413|Superiority or Other|||||||0.37|||||||Mantel Haenszel|||Holgers Index Month 24|
1645476|NCT01796236|3026413|Superiority or Other|||||||0.73|||||||Mantel Haenszel|||Holgers Index Month 12|
1645477|NCT01796236|3026413|Superiority or Other|||||||0.47|||||||Mantel Haenszel|||Holgers Index Week 24|
1645478|NCT01796236|3026413|Superiority or Other|||||||0.73|||||||Mantel Haenszel|||Holgers Index Week 12|
1645479|NCT01796236|3026413|Superiority or Other|||||||0.37|||||||Mantel Haenszel|||Holgers Index Week 6|
1645480|NCT01796236|3026413|Superiority or Other|||||||0.17|||||||Mantel Haenszel|||Holgers Index Week 3|
1645481|NCT01796236|3026413|Superiority or Other|||||||0.38|||||||Mantel Haenszel|||Holgers Index Day 10|
1645482|NCT01796236|3026414|Superiority or Other|||||||0.14|||||||Mantel Haenszel|||Maximum of Holgers at 36 Months|
1645483|NCT01796236|3026414|Superiority or Other|||||||0.4|||||||Mantel Haenszel|||Maximum of Holgers at 12 Months|
1645484|NCT01796236|3026415|Superiority or Other|||||||1|||||||Fisher Exact|||Week 24|
1645485|NCT01796236|3026415|Superiority or Other|||||||0.97|||||||Fisher Exact|||Week 12|
1645486|NCT01796236|3026415|Superiority or Other|||||||1|||||||Fisher Exact|||Week 6|
1645487|NCT01796236|3026415|Superiority or Other|||||||0.4|||||||Fisher Exact|||Week 3|
1645488|NCT01796236|3026415|Superiority or Other|||||||0.02|||||||Fisher Exact|||Day 10|
1645489|NCT01796236|3026416|Superiority or Other||||||<|0.0001|||||||Mann-Whitney U test||||
1645490|NCT01796236|3026417|Superiority or Other|||||||0.45|||||||Mantel Haenszel|||"Combined Endpoint is calculated as the sum of the following four events from 3 weeks to 3 years:~Holgers Index >=2. Any Overgrowth >=2. Pain (scar/neuropathic) >=3. Any numbness >=2.~Each event is counted only once"|
1645491|NCT01796236|3026418|Superiority or Other|||||||0.12|||||||Mantel Haenszel||||
1645492|NCT01795937|3026419|Non-Inferiority or Equivalence|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1678.23|Standard Deviation|22.6|||2-Sided|90.0|1468.52|1917.89|||||The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.|
1645493|NCT01795937|3026420|Non-Inferiority or Equivalence|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|3288.7|Standard Deviation|28.5|||2-Sided|90.0|2782.04|3887.63|||||The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.|
1645516|NCT01794000|3026500|Superiority or Other (legacy)|||||||0.133|||||||Log Rank|A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.||Time from Randomization to the Second VOC|
1645494|NCT01795937|3026421|Non-Inferiority or Equivalence|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1466.35|Standard Deviation|23.3|||2-Sided|90.0|1277.62|1682.95|||||The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison rosuvastatin+faldaprevir : rosuvastatin.|
1645495|NCT01795937|3026422|Non-Inferiority or Equivalence|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|1358.91|Standard Deviation|16.4|||2-Sided|90.0|1224.32|1508.29|||||The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.|
1645496|NCT01795937|3026425|Non-Inferiority or Equivalence|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|3372.72|Standard Deviation|20.5|||2-Sided|90.0|2961.95|3840.47|||||The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.|
1645497|NCT01795937|3026426|Non-Inferiority or Equivalence|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|946.45|Standard Deviation|27.3|||2-Sided|90.0|797.61|1123.07|||||The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison atorvastatin+faldaprevir : atorvastatin.|
1645498|NCT01795937|3026427|Non-Inferiority or Equivalence|Investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|180.63|Standard Deviation|14.5|||2-Sided|90.0|165.68|196.93|||||The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison faldaprevir+itraconazole : faldaprevir.|
1645499|NCT01795937|3026428|Non-Inferiority or Equivalence|Investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|198.55|Standard Deviation|14.2|||2-Sided|90.0|182.43|216.09|||||The standard deviation is actually the geometric coefficient of variation.|Relative bioavailability comparison faldaprevir+itraconazole : faldaprevir|
1645500|NCT01795859|3026434|Superiority or Other||Mean Difference (Final Values)|1.0||||0.1415|2-Sided|95.0|-0.3|2.3|||Mixed Models Analysis||||
1645501|NCT01795859|3026435|Superiority or Other||LSMean Difference|4.34||||0.0308|2-Sided|95.0|0.41|8.27|||Mixed Models Analysis||||
1645502|NCT01795859|3026436|Superiority or Other||Mean Difference (Final Values)|28.9||||0.0022|2-Sided|95.0|11.4|46.4|||Difference of proportions||||
1645503|NCT01795859|3026437|Superiority or Other||Mean Difference (Final Values)|31.1||||0.002|2-Sided|95.0|12.4|49.8|||Difference of proportions||||
1645504|NCT01795859|3026438|Superiority or Other||LSMean Difference|-2.49|||<|0.0001|2-Sided|95.0|-3.69|-1.29|||ANCOVA||||
1645505|NCT01795716|3026446|Non-Inferiority or Equivalence|The 90%CIs of the test/reference ratios for AUC0–∞ and Cmax were determined. Log-transformed data were used in the analysis. Following international guidelines (including those of the SFDA), the test and reference for mutations were considered bioequivalent if the 90% CIs of the test/reference ratios of AUC was within range of 0.80 to 1.25 and Cmax was within 0.70 to 1.43.|||||<|0.05|||||||ANOVA|||The 90% confidence intervals of the test/reference ratios for AUC0–∞ and Cmax were determined. Log-transformed data were used in the analysis. Following international guidelines (including those of the SFDA), the test and reference for mutations were considered bioequivalent if the 90% CIs of the test/reference ratios of AUC was within range of 0.80 to 1.25 and Cmax was within 0.70 to 1.43.|
1645506|NCT01795547|3026447|Superiority or Other||Least Squares Mean Difference|-0.695||||0.095|2-Sided|95.0|-1.511|0.121||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.|||
1645507|NCT01795547|3026448|Superiority or Other||Least Squares Mean Difference|1.007||||0.561|2-Sided|95.0|-2.402|4.417||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.|||
1645508|NCT01795547|3026449|Superiority or Other||Least Squares Mean Difference|0.922||||0.13|2-Sided|95.0|-0.275|2.119||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.|||
1645509|NCT01795547|3026450|Superiority or Other||Least Squares Mean Difference|1.764||||0.07|2-Sided|95.0|-0.143|3.672||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.|||
1645510|NCT01795547|3026451|Superiority or Other||Least Squares Mean Difference|1.753||||0.039|2-Sided|95.0|0.093|3.412||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.|||
1645511|NCT01795547|3026452|Superiority or Other||Least Squares Mean Difference|0.331||||0.149|2-Sided|95.0|-0.12|0.782||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.|||
1645512|NCT01795547|3026453|Superiority or Other||Least Squares Mean Difference|-0.283||||0.004|2-Sided|95.0|-0.477|-0.09||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.|||
1645513|NCT01795547|3026454|Superiority or Other||Least Squares Mean Difference|-1.492||||0.043|2-Sided|95.0|-2.935|-0.049||All secondary endpoints were tested without any hierarchical testing strategy and no adjustment for multiplicity|Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.|||
1645514|NCT01795547|3026455|Non-Inferiority or Equivalence|Non-inferiority of the primary endpoint was considered confirmed if the lower bound of the 2-sided 95% CI at Week 28 was > -5 or equivalently if the p-value for the 1-sided test of H0: D ≤ -5 against H1: D > -5 was ≤2.5%, where D was the mean treatment difference (aripiprazole minus paliperidone). Superiority was then tested as pre-specified with the FAS and demonstrated for aripiprazole over paliperidone, since the lower bound of the 95% CI was >0.|Least Squares Mean Difference|4.666||||0.036|2-Sided|95.0|0.316|9.015|||Mixed Models Analysis|The model uses an unstructured variance/covariance matrix.||Comparison of aripiprazole versus paliperidone was made using estimates from a mixed model for repeated measurements (MMRM) using an unstructured covariance matrix.|
1645515|NCT01794000|3026499|Superiority or Other (legacy)|||||||0.638|||||||Fisher Exact||||
1645536|NCT01791803|3026625|Superiority or Other||||||<|0.001|||||||ANOVA|||Comparison of smoking status at 12 weeks after hospitalization for a cardiac or pulmonary diagnosis|
1645517|NCT01794000|3026500|Superiority or Other (legacy)|||||||0.317|||||||Log Rank|A stratified log-rank test were performed with hydroxyurea use and age group as the stratification factors.||Time from Randomization to the First VOC|
1645518|NCT01794000|3026501|Superiority or Other (legacy)||Least Square Mean Difference|0.94||||0.662|2-Sided|95.0|-3.31|5.19||The ANCOVA model included the factors of treatment, hydroxyurea use, age group, and length of follow-up.|ANCOVA||The LS Mean difference of prasugrel minus placebo and 2-sided 95% CI were estimated from the ANCOVA model.||
1645519|NCT01794000|3026503|Superiority or Other (legacy)||Least Square Mean Difference|1.272||||0.459|2-Sided|95.0|-2.109|4.652||The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.||
1645520|NCT01794000|3026504|Superiority or Other (legacy)||Least Square Mean Difference|1.513||||0.602|2-Sided|95.0|-4.186|7.213||The MMRM model included the fixed effects of treatment, the baseline value of the pain-diary measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The Least Square Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.||
1645521|NCT01794000|3026505|Superiority or Other (legacy)||Rate Ratio|1.17||||0.544|2-Sided|95.0|0.71|1.91||The time to a recurrent episode of RBC transfusion was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.||
1645522|NCT01794000|3026506|Superiority or Other (legacy)||Rate Ratio|0.96||||0.916|2-Sided|95.0|0.48|1.93||The time to a recurrent episode of acute chest syndrome was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.||
1645523|NCT01794000|3026507|Superiority or Other (legacy)||Rate Ratio|0.94||||0.759|2-Sided|95.0|0.65|1.37||The time to a recurrent episode of hospitalization was analyzed using Andersen-Gill model.|Andersen-Gill model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.||
1645524|NCT01794000|3026508|Superiority or Other (legacy)||Rate Ratio|0.82||||0.109|2-Sided|95.0|0.65|1.04||The time to a recurrent episode of painful crisis was analyzed using Andersen-Gill model.|Andersen-Gill Model|A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|The rate ratio and 2-sided 95% CI were estimated from the Andersen-Gill model.||
1645525|NCT01794000|3026509|Superiority or Other (legacy)||Least Square Mean Difference|0.0968||||0.365|2-Sided|95.0|-0.1132|0.3068||MMRM model included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The LS Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.||
1645526|NCT01794000|3026510|Superiority or Other (legacy)||Least Square Mean Difference|-0.242||||0.912|2-Sided|95.0|-4.564|4.079||Mixed Model Repeated Measures (MMRM) included fixed effects of treatment, baseline value of the pain-diary outcome measure, hydroxyurea use, age group, time and treatment-by-time interaction.|Mixed Models Analysis||The Least Square (LS) Mean difference of prasugrel minus placebo and the corresponding 2-sided 95% CI were estimated from the MMRM model.||
1645527|NCT01794000|3026511|Superiority or Other (legacy)||Rate Ratio|0.83||||0.117|2-Sided|95.0|0.66|1.05|||Andersen-Gill model||The rate ratio and 2-sided 95% Confidence Interval (CI) were estimated from the Andersen-Gill model.|The time to a recurrent episode of VOC was analyzed using Andersen-Gill model. A robust variance estimate was used, with treatment, hydroxyurea use at baseline and age group included as factors in the model.|
1645528|NCT01793883|3026529|Superiority|||||||0.818|||||||Log Rank||||
1645529|NCT01793883|3026529|Superiority|||||||0.251|||||||Log Rank||||
1645530|NCT01792518|3026592|Superiority or Other||Mean Difference (Final Values)|-2.63|Standard Error of the Mean|2.7||0.3306|2-Sided|95.0|-7.95|2.68|||Mixed Models Analysis|The Unstructured covariance structure has been used to fit the mixed model|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Change in eGFR is analysed using mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline log10 (UACR), baseline eGFR, baseline HbA1c by visit, baseline log10 (UACR) by visit and baseline eGFR by visit as linear covariates and treatment, visit, visit by treatment interaction as fixed effects.|
1645531|NCT01792518|3026593|Superiority or Other||Ratio of adjusted geometric means|0.94||||0.1954|2-Sided|95.0|0.85|1.03|||ANCOVA||Ratio of relative change for Linagliptin 5 mg over placebo is presented.|Superiority of Linagliptin 5 mg vs. placebo: change in UACR is analysed using analysis of covariance model. Model includes baseline HbA1c and baseline log10 (UACR) as linear covariates and treatment as fixed effect.|
1645532|NCT01792518|3026594|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.78|-0.43|||Mixed Models Analysis|The Unstructured covariance structure has been used to fit the mixed model|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change in HbA1c is analysed using mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline log10 (UACR), baseline HbA1c by visit and baseline log10 (UACR) by visit as linear covariates and treatment, visit, visit by treatment interaction as fixed effects.|
1645533|NCT01791972|3026619|Superiority or Other||Mean Difference (Final Values)|0.68|Standard Error of the Mean|0.075|<|0.0001|2-Sided|95.0|0.53|0.84||Terms for treatment and period, computed with the generalized estimating equations (GEE) algorithm, which adjusts for potential correlation between measurements on the same patient. Significance level of 0.05.|Regression, Logistic||||
1645534|NCT01791972|3026620|Superiority or Other||Mean Difference (Final Values)|-16.2|Standard Error of the Mean|1.982|<|0.0001|2-Sided|95.0|-20.19|-12.14||Significance level is 0.05.|mixed-effect analysis of covariance|Fixed effects of sequence, trt group, period, and center, within period baseline FEV1 as a covariate, and random effect for patient within sequence.|||
1645535|NCT01791803|3026625|Superiority or Other|||||||0.07|||||||ANOVA|||Comparison of smoking stars at 26 weeks after hospitalization for a cardiac or a pulmonary illness|
1645537|NCT01791803|3026626|Superiority or Other||Risk Ratio (RR)|2.3|||||2-Sided|95.0|1.2|10.0|||||||
1645538|NCT01791803|3026626|Superiority or Other||Risk Ratio (RR)|2.0|||||2-Sided|95.0|0.8|6.2|||||||
1645539|NCT01791803|3026627|Superiority or Other||Risk Ratio (RR)|2.4|||||2-Sided|95.0|1.04|9.7|||||||
1645540|NCT01791803|3026627|Superiority or Other||Risk Ratio (RR)|2.6|||||2-Sided|95.0|1.1|11.4|||||||
1645541|NCT01791465|3026645|Superiority or Other|||||||0.046|||||||Wilcoxon (Mann-Whitney)||||
1645542|NCT01791465|3026646|Superiority or Other|||||||0.12|||||||Wilcoxon (Mann-Whitney)||||
1645543|NCT01791465|3026647|Superiority or Other|||||||0.25|||||||Wilcoxon (Mann-Whitney)||||
1645544|NCT01791465|3026648|Superiority or Other|||||||0.046|||||||Wilcoxon (Mann-Whitney)||||
1645545|NCT01791465|3026649|Superiority or Other|||||||0.75|||||||Wilcoxon (Mann-Whitney)||||
1645546|NCT01791465|3026650|Superiority or Other|||||||0.89|||||||Wilcoxon (Mann-Whitney)||||
1645547|NCT01791465|3026651|Superiority or Other|||||||0.42|||||||Wilcoxon (Mann-Whitney)||||
1645548|NCT01791465|3026652|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1645549|NCT01791465|3026653|Superiority or Other|||||||0.69|||||||Wilcoxon (Mann-Whitney)||||
1645550|NCT01791465|3026654|Superiority or Other|||||||0.07|||||||Wilcoxon (Mann-Whitney)||||
1645551|NCT01791465|3026655|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1645552|NCT01791465|3026656|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1645553|NCT01791465|3026657|Superiority or Other|||||||0.6|||||||Wilcoxon (Mann-Whitney)||||
1645554|NCT01791465|3026658|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1645555|NCT01791465|3026659|Superiority or Other|||||||0.92|||||||Wilcoxon (Mann-Whitney)||||
1645556|NCT01791465|3026660|Superiority or Other|||||||0.47|||||||Wilcoxon (Mann-Whitney)||||
1645557|NCT01791465|3026661|Superiority or Other|||||||0.69|||||||Wilcoxon (Mann-Whitney)||||
1645558|NCT01791465|3026662|Superiority or Other|||||||0.92|||||||Wilcoxon (Mann-Whitney)||||
1645559|NCT01791465|3026663|Superiority or Other|||||||0.046|||||||Wilcoxon (Mann-Whitney)||||
1645560|NCT01791465|3026664|Superiority or Other|||||||0.34||||||Unadjusted - this was a Wilcoxon signed rank p-value (Baseline vs. week 16) comparison|Wilcoxon (Mann-Whitney)|no adjustments||The null hypothesis was that there would be no difference between baseline and 16 week IL-6|
1645561|NCT01791465|3026665|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1645562|NCT01791244|3026682|Superiority or Other||Adjusted Mean Difference|0.48||||0.9148|2-Sided|95.0|-8.3|9.25|||linear mixed model|||Linear mixed model, with baseline value, time, Expanded Disability Status Score (EDSS) at baseline and sex as fixed factors was used for the analysis.|
1645563|NCT01791205|3026714|Superiority or Other|||||||0.021|||||||Pearson's chi-squared test||||
1645564|NCT01791205|3026715|Superiority or Other||Delta|-0.042||||0.6908|2-Sided|95.0|-0.251|0.167|||t-test, 2 sided||||
1645565|NCT01791205|3026716|Superiority or Other||Odds Ratio (OR)|1.211||||0.49|2-Sided|95.0|0.703|2.086|||Regression, Logistic||||
1645566|NCT01791205|3026717|Superiority or Other|||||||0.3895|||||||Regression, Cox||||
1645567|NCT01791205|3026718|Superiority or Other||Hazard Ratio (HR)|3.538||||0.1194|2-Sided|95.0|0.65|19.33||The relation between retention rate and duration of disease for phase II was estimated with the Cox regression model.|Regression, Cox|||The relation between retention rate and DAS28 (<2.6 vs <3.2) was assayed with the Cox regression.|
1645568|NCT01791153|3026743|Superiority or Other (legacy)||Difference in Least Square Means|-18.2||||0.0081|2-Sided|99.0|-35.8|-0.5|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.|
1645569|NCT01791153|3026743|Superiority or Other (legacy)||Difference in Least Square Means|-21.9||||0.0059|2-Sided|99.0|-42.4|-1.4|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.|
1645570|NCT01791153|3026743|Superiority or Other (legacy)||Difference in Least Square Means|-11.8||||0.0476|2-Sided|99.0|-27.2|3.6|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.|
1645571|NCT01791153|3026743|Superiority or Other (legacy)||Difference in Least Square Means|-15.6||||0.0312|2-Sided|99.0|-34.3|3.1|||Repeated measures model|||Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.|
1645572|NCT01791153|3026744|Superiority or Other (legacy)||Difference in Least Square Means|4.25||||0.0412|2-Sided|99.0|-1.14|9.64|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.|
1645573|NCT01791153|3026744|Superiority or Other (legacy)||Difference in Least Square Means|3.04||||0.2218|2-Sided|99.0|-3.43|9.51|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.|
1645594|NCT01790633|3026798|Superiority or Other|||||||0.7||||||P-value adjustments for multiple comparisons were not necessary. Significance was determined using P < 0.05|Chi-squared||||
1645632|NCT01788163|3027040|Superiority or Other||Odds Ratio (OR)|2.077||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for model entry|||
1645574|NCT01791153|3026744|Superiority or Other (legacy)||Difference in Least Square Means|5.59||||0.0024|2-Sided|99.0|0.86|10.32|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.|
1645575|NCT01791153|3026744|Superiority or Other (legacy)||Difference in Least Square Means|4.38||||0.057|2-Sided|99.0|-1.58|10.34|||Repeated measures model|||PCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.|
1645576|NCT01791153|3026744|Superiority or Other (legacy)||Difference in Least Square Means|3.27||||0.1468|2-Sided|99.0|-2.59|9.14|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.|
1645577|NCT01791153|3026744|Superiority or Other (legacy)||Difference in Least Square Means|-0.56||||0.8374|2-Sided|99.0|-7.64|6.53|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.|
1645578|NCT01791153|3026744|Superiority or Other (legacy)||Difference in Least Square Means|4.44||||0.0252|2-Sided|99.0|-0.69|9.56|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.|
1645579|NCT01791153|3026744|Superiority or Other (legacy)||Difference in Least Square Means|0.61||||0.8067|2-Sided|99.0|-5.86|7.07|||Repeated measures model|||MCS: Change at Week 52: Repeated measures model used for analysis included the following covariates and interactions: treatment, starting prednisone dose (<=30mg/day, >30mg/day), visit, treatment-by-visit interaction, starting dose-by-visit interaction, baseline score and baseline score-by-visit interaction.|
1645580|NCT01791153|3026745|Superiority or Other (legacy)||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (<=30 mg/day, > 30 mg/day).|
1645581|NCT01791153|3026745|Superiority or Other (legacy)||||||<|0.0003|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (<=30mg/day, >30mg/day).|
1645582|NCT01791153|3026745|Superiority or Other (legacy)||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (<=30 mg/day, > 30 mg/day).|
1645583|NCT01791153|3026745|Superiority or Other (legacy)||||||<|0.0001|||||||Van Elteren's test|||The treatment groups were compared using a Van Elteren's test stratified by starting prednisone dose (<=30 mg/day, > 30 mg/day).|
1645584|NCT01791153|3026746|Superiority or Other (legacy)||Hazard Ratio (HR)|0.48||||0.0316|2-Sided|99.0|0.2|1.16|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).|
1645585|NCT01791153|3026746|Superiority or Other (legacy)||Hazard Ratio (HR)|0.28||||0.0001|2-Sided|99.0|0.12|0.66|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).|
1645586|NCT01791153|3026746|Superiority or Other (legacy)||Hazard Ratio (HR)|0.39||||0.0011|2-Sided|99.0|0.18|0.82|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).|
1645587|NCT01791153|3026746|Superiority or Other (legacy)||Hazard Ratio (HR)|0.23|||<|0.0001|2-Sided|99.0|0.11|0.46|||Cox proportional hazards model|||The treatment groups were compared using a Cox proportional hazards model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).|
1645588|NCT01791153|3026747|Non-Inferiority or Equivalence (legacy)|The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was >/= -22.5%.|Difference in Response Rates|35.41|||||2-Sided|99.5|10.41|60.41||||||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).|
1645589|NCT01791153|3026747|Superiority or Other (legacy)|||||||0.0002|||||||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).|
1645590|NCT01791153|3026747|Non-Inferiority or Equivalence (legacy)|The tocilizumab group was to be considered as non-inferior to the placebo group if the lower limit of the two-sided 99.5% confidence interval was >/= -22.5%.|Difference in Response Rates|38.35|||||2-Sided|99.5|17.89|58.81||||||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).|
1645591|NCT01791153|3026747|Superiority or Other (legacy)||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).|
1645592|NCT01791153|3026748|Superiority or Other (legacy)||Difference in Response Rates|39.06|||<|0.0001|2-Sided|99.5|12.46|65.66|||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (</=30 mg/day, >30 mg/day).|
1645593|NCT01791153|3026748|Superiority or Other (legacy)||Difference in Response Rates|42.0|||<|0.0001|2-Sided|99.5|18.0|66.0|||Cochran-Mantel-Haenszel|||The treatment groups were compared using a Cochran-Mantel-Haenszel model adjusted for the stratification factor of starting prednisone dose (less than or equal to [</=] 30 mg/day, greater than [>] 30 mg/day).|
1646100|NCT01783080|3027558|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.11|2-Sided||||||Regression, Linear||||
1645595|NCT01790633|3026799|Superiority or Other||||||<|0.001||||||P-value adjustments for multiple comparisons were not necessary. Significance was determined using P < 0.05|Chi-squared|||We approached our analysis as a pilot study with the aim of addressing feasibility. 70% of patients seen at the MDM clinic obtain a test result with standard serology. Assuming a 20% increase in infection awareness and type 1 error of 0.05, and power of at least 0.9, a minimum of 82 participants per group would be needed.|
1645596|NCT01790594|3026830|Superiority||Mean Difference (Final Values)|2.088||||0.75|2-Sided|95.0|-11.067|15.242|||Mixed Models Analysis|||The p-value compares Investigational arm and control arm.|
1645597|NCT01790581|3026833|Superiority or Other|||||||0.5|||||||MANOVA|||This analysis examined the change in disability scores from baseline to 1-day post intervention for both disability scores (FAAM, FAAM-S) using a MANOVA.|
1645598|NCT01790581|3026835|Superiority or Other|||||||0.904|||||||MANOVA|||This analysis examined the change in balance scores from baseline to 1-day post intervention for all three reach distances (Anterior, Posteriomedial, Posteriolateral) using a MANOVA.|
1645599|NCT01790503|3026844|Other|||||||0.348|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated|
1645600|NCT01790503|3026844|Other|||||||0.099|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100|
1645601|NCT01790503|3026844|Other||||||>|0.999|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection|
1645602|NCT01790503|3026844|Other||||||>|0.705|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years|
1645603|NCT01790503|3026845|Other|||||||0.501|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated|
1645604|NCT01790503|3026845|Other||||||<|0.001|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100|
1645605|NCT01790503|3026845|Other||||||<|0.969|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection|
1645606|NCT01790503|3026845|Other||||||<|0.063|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years|
1645607|NCT01790503|3026846|Other||Hazard Ratio (HR)|0.98||||0.469|2-Sided|95.0|0.63|1.54|||Log Rank||||
1645608|NCT01790503|3026846|Other||Hazard Ratio (HR)|0.94||||0.393|2-Sided|95.0|0.63|1.42|||Log Rank||||
1645609|NCT01790503|3026846|Other||Hazard Ratio (HR)|0.94||||0.389|2-Sided|95.0|0.6|1.47|||Log Rank||||
1645610|NCT01790503|3026848|Other|||||||0.201|||||||t-test, 2 sided|||Comparison between MGMT status subgroups: methylated vs unmethylated|
1645611|NCT01790503|3026848|Other|||||||0.003|||||||t-test, 2 sided|||Comparison between baseline KPS subgroups: 70-89 vs 90-100|
1645612|NCT01790503|3026848|Other|||||||0.699|||||||t-test, 2 sided|||Comparison between extent of surgery subgroups: complete resection vs partial resection|
1645613|NCT01790503|3026848|Other|||||||0.44|||||||t-test, 2 sided|||Comparison between age subgroups: 18-64 years vs 65+ years|
1645614|NCT01790503|3026849|Other||Hazard Ratio (HR)|0.9||||0.272|2-Sided|95.0|0.65|1.26|||Log Rank||||
1645615|NCT01790503|3026849|Other||Hazard Ratio (HR)|1.05||||0.619|2-Sided|95.0|0.77|1.43|||Log Rank||||
1645616|NCT01790503|3026849|Other||Hazard Ratio (HR)|0.98||||0.456|2-Sided|95.0|0.71|1.36|||Log Rank||||
1645617|NCT01789970|3026931|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.557|2-Sided|95.0|-1.2|0.65||5% significance level|ANCOVA|Model with the following effects: treatment, study center, opioid status, and baseline RMDQ score.|Placebo - Hydrocodone ER||
1645618|NCT01789970|3026932|Superiority or Other||Odds Ratio (OR)|0.67||||0.0293|2-Sided|95.0|0.47|0.96||5% significance level|Regression, Logistic|stratified by center with the following effects: treatment group, baseline API, and opioid status.|Hydrocodone ER / Placebo|API increase >=30% and API >=5|
1645619|NCT01789970|3026933|Superiority or Other||Hazard Ratio (HR)|0.68||||0.059|2-Sided|95.0|0.5|1.01||5% significance level|Wald chi-square|Cox proportional hazards model with treatment, baseline worst pain intensity (WPI), opioid status, and center in the model|||
1645620|NCT01789970|3026934|Superiority or Other||Mean Difference (Final Values)|0.58|||<|0.001|2-Sided|95.0|0.25|0.91||5% significance level|ANCOVA|The model included treatment, study center, opioid status, and baseline WPI score.|Placebo - Hydrocodone ER|The least squares means of the change from baseline to week 12 in API were compared between the active drug and placebo treatment groups.|
1645621|NCT01789970|3026935|Superiority or Other||Mean Difference (Final Values)|0.63|||<|0.001|2-Sided|95.0|0.26|1.0||5% significance level|ANCOVA|The model included treatment, study center, opioid status, and baseline WPI score.|Placebo - Hydrocodone ER|The least squares means of the change from baseline to week 12 in WPI were compared between the active drug and placebo treatment groups.|
1645622|NCT01789814|3026939|Superiority or Other|||||||0.001||||||Prasugrel treatment when compared to Clopidogrel was associated with significant reduction in platelets aggregation for all plateles agonist (ADD, SFFFLRN, AYPGKF) at all measured time points.|t-test, 2 sided|||Each patient will have paired samples representing their baseline as well as an on-drug sample. The magnitude of platelet inhibition for each studied agonist will be performed utilizing mean maximal change from baseline in light transmission aggregometry. The paired samples will be analyzed using a two-tailed student's t-test. Statistical significance will be assumed to occur when p<0.05.|
1645623|NCT01789476|3026961|Superiority or Other||||||<|0.03||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA||||
1645624|NCT01789476|3026962|Superiority or Other||||||<|0.03||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA||||
1645625|NCT01789476|3026963|Superiority or Other||||||<|0.05||||||One-sided ANOVA with Treatment Group as a Main Effect|ANOVA||||
1645626|NCT01789255|3026964|Other|||||||0.028|||||||Wilcoxon (Mann-Whitney)||||
1645627|NCT01789255|3026965|Other|||||||0.02642|||||||Wilcoxon (Mann-Whitney)||||
1645628|NCT01788943|3026989|Other|||||||0.01|||||||t-test, 2 sided||||
1645629|NCT01788943|3026990|Other|||||||0.037|||||||ANOVA||||
1645630|NCT01788163|3027040|Superiority or Other||Odds Ratio (OR)|2.084||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for model entry|||
1645631|NCT01788163|3027040|Superiority or Other||Wald Chi Square Statistic|21.2537||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for entry criteria|||
1645633|NCT01788163|3027040|Superiority or Other||Wald Chi Square Statistic|33.8574||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for entry criteria|||
1645634|NCT01788163|3027040|Superiority or Other||Odds Ratio (OR)|1.955||||0.0002||||||Histology: Adenocarcinoma vs. Non-adenocarcinoma|Regression Stepwise|10% Significance Level for model entry|||
1645635|NCT01788163|3027040|Superiority or Other||Wald Chi Square Statistic|14.0806||||0.0002||||||Histology: Adenocarcinoma vs. Non-adenocarcinoma|Regression Stepwise|10% Significance Level for entry criteria|||
1645636|NCT01788163|3027040|Superiority or Other||Odds Ratio (OR)|1.386||||0.0001||||||Number of Organs with Metastisis|Regression Stepwise|10% significance level for model entry|||
1645637|NCT01788163|3027040|Superiority or Other||Wald Chi Square Statistic|34.1075||||0.0001||||||Number of Organs with Metastisis|Regression Stepwise|10% Significance Level for entry criteria|||
1645638|NCT01788163|3027040|Superiority or Other||Odds Ratio (OR)|1.561||||0.0009||||||Age: <=65 vs. >65|Regression Stepwise|10% Significance Level for model entry|||
1645639|NCT01788163|3027040|Superiority or Other||Wald Chi Square Statistic|11.106||||0.0009||||||Age: <=65 vs. >65|Regression Stepwise|10% Significance Level for entry criteria|||
1645640|NCT01788163|3027043|Superiority or Other||Odds Ratio (OR)|1.086||||0.0909||||||Number of organs with metastasis|Regression Stepwise|10% significance level for model entry|||
1645641|NCT01788163|3027043|Superiority or Other||Wald Chi Square Statistic|2.8589||||0.0909||||||Number of organs with metastasis|Regression Stepwise|10% significance level for entry criteria|||
1645642|NCT01788163|3027043|Superiority or Other||Odds Ratio (OR)|3.929||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for model entry|||
1645643|NCT01788163|3027043|Superiority or Other||Wald Chi Square Statistic|98.1065||||0.0001||||||Region: Asia Pacific vs. Russia|Regression Stepwise|10% Significance Level for entry criteria|||
1645644|NCT01788163|3027043|Superiority or Other||Odds Ratio (OR)|2.515||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% Significance Level for model entry|||
1645645|NCT01788163|3027043|Superiority or Other||Wald Chi Square Statistic|51.8456||||0.0001||||||Smoking Status: Never-smoker vs. Ever-smoker|Regression Stepwise|10% significance level for entry criteria|||
1645646|NCT01788163|3027043|Superiority or Other||Odds Ratio (OR)|1.409||||0.0075||||||Gender: Male vs. Female|Regression Stepwise|10% Significance Level for model entry|||
1645647|NCT01788163|3027043|Superiority or Other||Wald Chi Square Statistic|7.1526||||0.0075||||||Gender: Male vs. Female|Regression Stepwise|10% significance level for entry criteria|||
1645648|NCT01788163|3027043|Superiority or Other||Odds Ratio (OR)|3.973||||0.0001||||||Histology: Adenocarcinoma vs Non-adenocarcinoma|Regression stepwise|10% significance level for model entry|||
1645649|NCT01788163|3027043|Superiority or Other||Wald Chi Square Statistic|81.1237||||0.0001||||||Histology: Adenocarcinoma vs Non-adenocarcinoma|Regression stepwise|10% significance level for entry criteria|||
1645650|NCT01788046|3027059|Superiority or Other||Mean Difference|-8.04|Standard Error of the Mean|2.09|<|0.001|2-Sided|95.0|-12.15|-3.92|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo||
1645651|NCT01788046|3027060|Superiority or Other||Mean Difference|-14.58|Standard Error of the Mean|2.07|<|0.001|2-Sided|95.0|-18.65|-10.51|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo||
1645652|NCT01788046|3027061|Superiority or Other||Mean Difference|-7.2|Standard Error of the Mean|0.6|<|0.001|2-Sided|95.0|-8.38|-6.03|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo||
1645653|NCT01788046|3027062|Superiority or Other||Mean Difference|-71.34|Standard Error of the Mean|3.15|<|0.001|2-Sided|95.0|-77.53|-65.14|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo||
1645654|NCT01788046|3027063|Superiority or Other||Odds Ratio (OR)|33.92|||<|0.001|2-Sided|95.0|16.35|70.37|||Cochran-Mantel-Haenszel|Stratified by screening PTH category, prior cinacalcet use within 8 weeks prior to randomization, and region.|||
1645655|NCT01788046|3027064|Superiority or Other||Odds Ratio (OR)|30.8|||<|0.001|2-Sided|95.0|18.18|52.17|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel test stratified by screening PTH category (< 600, ≥ 600 to ≤ 1000, and > 1000 pg/mL), recent cinacalcet use within 8 weeks before randomization (yes and no), and region (North America and non-North America) was used to compare the primary endpoint of percentage of participants with > 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.|
1645656|NCT01787838|3027067|Superiority or Other||Odds Ratio (OR)|1.8|||<|0.0001|2-Sided|95.0|1.65|1.96|||Chi-squared|||Prospective data from 12 months were compared to data that had been collected for the previous 12 month period to determine statistical significance and trended outcomes for comparative periods. Patients were screened for eligibility during the first 12 months, and staff and patients received the interventions during the second 12 month period.|
1645657|NCT01787825|3027069|Superiority or Other||percentage concordance|71.93||||0.972|2-Sided|95.0|63.07|79.36|||Bowkers||||
1645658|NCT01787825|3027071|Non-Inferiority|This is McNemar design.|percentage concordance|77.19||||1|2-Sided|95.0|68.68|83.93||The blinded readers assessed concordance of normal versus abnormal and overall concordance of clinically significant abnormal images.|McNemar||Overall concordance of clinically significant abnormal images.|There was a comparison between normal and abnormal images. And detailed analysis of abnormal images that were considered clinical significant.|
1645659|NCT01787461|3027098|Superiority or Other||LS Mean Difference|0.81||||0.576|2-Sided|95.0|-2.06|3.68|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645784|NCT01787188|3027152|Superiority or Other||Difference in Least Squares Mean|-10.98|Standard Error of the Mean|2.831||0.0001|2-Sided|95.0|-16.55|-5.41|||Mixed Models Analysis||||
1646429|NCT01778127|3028059|Superiority or Other|||||||0.18|||||||t-test, 2 sided||||
1645660|NCT01787461|3027098|Superiority or Other||LS Mean Difference|-0.67||||0.63|2-Sided|95.0|-3.41|2.08|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645661|NCT01787461|3027098|Superiority or Other||LS Mean Difference|-1.42||||0.218|2-Sided|95.0|-3.69|0.85|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645662|NCT01787461|3027098|Superiority or Other||LS Mean Difference|0.02||||0.987|2-Sided|95.0|-2.44|2.48|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645663|NCT01787461|3027098|Superiority or Other||LS Mean Difference|0.55||||0.745|2-Sided|95.0|-2.79|3.89|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645664|NCT01787461|3027098|Superiority or Other||LS Mean Difference|-1.36||||0.453|2-Sided|95.0|-4.96|2.23|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645665|NCT01787461|3027098|Superiority or Other||LS Mean Difference|-1.85||||0.243|2-Sided|95.0|-4.96|1.27|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645666|NCT01787461|3027098|Superiority or Other||LS Mean Difference|1.24||||0.495|2-Sided|95.0|-2.34|4.82|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645667|NCT01787461|3027098|Superiority or Other||LS Mean Difference|-0.34||||0.708|2-Sided|95.0|-2.11|1.44|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645668|NCT01787461|3027098|Superiority or Other||LS Mean Difference|-1.36||||0.113|2-Sided|95.0|-3.05|0.33|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645669|NCT01787461|3027098|Superiority or Other||LS Mean Difference|-0.53||||0.497|2-Sided|95.0|-2.07|1.01|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645670|NCT01787461|3027098|Superiority or Other||LS Mean Difference|-0.6||||0.458|2-Sided|95.0|-2.21|1.0|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645671|NCT01787461|3027099|Superiority or Other||LS Mean Difference|8.58||||0.667|2-Sided|95.0|-30.78|47.94|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645672|NCT01787461|3027099|Superiority or Other||LS Mean Difference|-9.88||||0.566|2-Sided|95.0|-43.81|24.05|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645673|NCT01787461|3027099|Superiority or Other||LS Mean Difference|1.49||||0.916|2-Sided|95.0|-26.44|29.43|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645674|NCT01787461|3027099|Superiority or Other||LS Mean Difference|12.43||||0.381|2-Sided|95.0|-15.49|40.35|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645675|NCT01787461|3027099|Superiority or Other||LS Mean Difference|14.42||||0.402|2-Sided|95.0|-19.5|48.34|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645676|NCT01787461|3027099|Superiority or Other||LS Mean Difference|-16.49||||0.315|2-Sided|95.0|-48.81|15.83|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645677|NCT01787461|3027099|Superiority or Other||LS Mean Difference|6.35||||0.648|2-Sided|95.0|-21.04|33.75|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645678|NCT01787461|3027099|Superiority or Other||LS Mean Difference|4.54||||0.715|2-Sided|95.0|-19.94|29.01|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645679|NCT01787461|3027099|Superiority or Other||LS Mean Difference|-14.9||||0.632|2-Sided|95.0|-76.32|46.51|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645680|NCT01787461|3027099|Superiority or Other||LS Mean Difference|-7.78||||0.753|2-Sided|95.0|-56.55|40.99|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645681|NCT01787461|3027099|Superiority or Other||LS Mean Difference|-28.79||||0.21|2-Sided|95.0|-73.99|16.41|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645682|NCT01787461|3027099|Superiority or Other||LS Mean Difference|-25.16||||0.266|2-Sided|95.0|-69.63|19.31|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645683|NCT01787461|3027100|Superiority or Other||LS Mean Difference|0.24||||0.264|2-Sided|95.0|-0.17|0.64|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645684|NCT01787461|3027100|Superiority or Other||LS Mean Difference|0.22||||0.317|2-Sided|95.0|-0.2|0.63|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645685|NCT01787461|3027100|Superiority or Other||LS Mean Difference|0.12||||0.594|2-Sided|95.0|-0.32|0.56|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645686|NCT01787461|3027100|Superiority or Other||LS Mean Difference|0.25||||0.244|2-Sided|95.0|-0.17|0.66|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645687|NCT01787461|3027100|Superiority or Other||LS Mean Difference|0.35||||0.1|2-Sided|95.0|-0.06|0.77|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645688|NCT01787461|3027100|Superiority or Other||LS Mean Difference|0.27||||0.205|2-Sided|95.0|-0.14|0.68|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645689|NCT01787461|3027100|Superiority or Other||LS Mean Difference|0.37||||0.105|2-Sided|95.0|-0.07|0.8|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645690|NCT01787461|3027100|Superiority or Other||LS Mean Difference|0.22||||0.449|2-Sided|95.0|-0.36|0.8|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645691|NCT01787461|3027100|Superiority or Other||LS Mean Difference|1.17||||0.019|2-Sided|95.0|0.2|2.14|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645692|NCT01787461|3027100|Superiority or Other||LS Mean Difference|0.99||||0.049|2-Sided|95.0|0.01|1.96|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645693|NCT01787461|3027100|Superiority or Other||LS Mean Difference|1.1||||0.027|2-Sided|95.0|0.12|2.09|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645694|NCT01787461|3027100|Superiority or Other||LS Mean Difference|0.78||||0.214|2-Sided|95.0|-0.46|2.02|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645695|NCT01787461|3027101|Superiority or Other||LS Mean Difference|-6.75||||0.225|2-Sided|95.0|-17.7|4.2|||ANOVA|||Change at Week 24, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645696|NCT01787461|3027101|Superiority or Other||LS Mean Difference|-3.82||||0.51|2-Sided|95.0|-15.23|7.6|||ANOVA|||Change at Week 18, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645697|NCT01787461|3027101|Superiority or Other||LS Mean Difference|-3.33||||0.603|2-Sided|95.0|-15.96|9.29|||ANOVA|||Change at Week 12, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645698|NCT01787461|3027101|Superiority or Other||LS Mean Difference|-1.82||||0.776|2-Sided|95.0|-14.39|10.76|||ANOVA|||Change at Week 6, Left Outer Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645699|NCT01787461|3027101|Superiority or Other||LS Mean Difference|-9.07||||0.107|2-Sided|95.0|-20.04|1.9|||ANOVA|||Change at Week 24, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645700|NCT01787461|3027101|Superiority or Other||LS Mean Difference|-5.98||||0.299|2-Sided|95.0|-17.29|5.34|||ANOVA|||Change at Week 18, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645701|NCT01787461|3027101|Superiority or Other||LS Mean Difference|5.74||||0.48|2-Sided|95.0|-11.67|23.15|||ANOVA|||Change at Week 12, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645702|NCT01787461|3027101|Superiority or Other||LS Mean Difference|2.61||||0.685|2-Sided|95.0|-10.07|15.28|||ANOVA|||Change at Week 6, Left Inner Arm: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645703|NCT01787461|3027101|Superiority or Other||LS Mean Difference|-9.16||||0.191|2-Sided|95.0|-22.92|4.61|||ANOVA|||Change at Week 24, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645704|NCT01787461|3027101|Superiority or Other||LS Mean Difference|-3.57||||0.453|2-Sided|95.0|-16.14|8.99|||ANOVA|||Change at Week 18, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645705|NCT01787461|3027101|Superiority or Other||LS Mean Difference|-1.08||||0.814|2-Sided|95.0|-14.49|12.32|||ANOVA|||Change at Week 12, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645706|NCT01787461|3027101|Superiority or Other||LS Mean Difference|3.93||||0.587|2-Sided|95.0|-10.32|18.18|||ANOVA|||Change at Week 6, Left Cheek: Analysis was performed using ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645707|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|-0.013||||0.662|2-Sided|95.0|-0.16|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 24, Body – Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645708|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|0.079||||0.762|2-Sided|95.0|-0.06|0.22|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands – Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645709|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|-0.011||||0.693|2-Sided|95.0|-0.18|0.16|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645710|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|0.003||||0.614|2-Sided|95.0|-0.13|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 24, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645711|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|0.205||||0.112|2-Sided|95.0|0.07|0.34|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645712|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|0.193||||0.11|2-Sided|95.0|-0.02|0.41|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645713|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|0.206||||0.088|2-Sided|95.0|0.02|0.39|||Cochran-Mantel-Haenszel|||Improvement Week 24, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645714|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|-0.035||||0.857|2-Sided|95.0|-0.2|0.13|||Cochran-Mantel-Haenszel|||Improvement Week 12, Body – Dryness Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645715|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|-0.031||||0.294|2-Sided|95.0|-0.19|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands – Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645716|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|0.1||||0.373|2-Sided|95.0|-0.05|0.25|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands - Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645717|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|-0.096||||0.662|2-Sided|95.0|-0.31|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Back of Hands-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645718|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|0.057||||0.117|2-Sided|95.0|-0.11|0.22|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645719|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|0.248||||0.073|2-Sided|95.0|0.09|0.4|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Wrinkling/crinkling: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645720|NCT01787461|3027102|Superiority or Other||Weighted Gamma Statistic|0.384||||0.017|2-Sided|95.0|0.23|0.54|||Cochran-Mantel-Haenszel|||Improvement Week 12, Decolletage-Overall: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645721|NCT01787461|3027103|Superiority or Other||Weighted Gamma Statistic|0.061||||0.687|2-Sided|95.0|-0.14|0.26|||Cochran-Mantel-Haenszel|||Improvement Week 24, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645722|NCT01787461|3027103|Superiority or Other||Weighted Gamma Statistic|0.118||||0.405|2-Sided|95.0|-0.05|0.28|||Cochran-Mantel-Haenszel|||Improvement Week 24, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645723|NCT01787461|3027103|Superiority or Other||Weighted Gamma Statistic|-0.033||||0.942|2-Sided|95.0|-0.23|0.16|||Cochran-Mantel-Haenszel|||Improvement Week 24, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645724|NCT01787461|3027103|Superiority or Other||Weighted Gamma Statistic|-0.02||||0.796|2-Sided|95.0|-0.16|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 24, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645725|NCT01787461|3027103|Superiority or Other||Weighted Gamma Statistic|0.226||||0.171|2-Sided|95.0|0.06|0.39|||Cochran-Mantel-Haenszel|||Improvement Week 24, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645726|NCT01787461|3027103|Superiority or Other||Weighted Gamma Statistic|0.03||||0.833|2-Sided|95.0|-0.13|0.19|||Cochran-Mantel-Haenszel|||Improvement Week 24, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645727|NCT01787461|3027103|Superiority or Other||Weighted Gamma Statistic|0.059||||0.432|2-Sided|95.0|-0.13|0.25|||Cochran-Mantel-Haenszel|||Improvement Week 12, Smoothness: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645728|NCT01787461|3027103|Superiority or Other||Weighted Gamma Statistic|-0.018||||0.996|2-Sided|95.0|-0.23|0.19|||Cochran-Mantel-Haenszel|||Improvement Week 12, Complexion/Glow: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645729|NCT01787461|3027103|Superiority or Other||Weighted Gamma Statistic|-0.012||||0.633|2-Sided|95.0|-0.15|0.12|||Cochran-Mantel-Haenszel|||Improvement Week 12, Discoloration: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645730|NCT01787461|3027103|Superiority or Other||Weighted Gamma Statistic|0.205||||0.318|2-Sided|95.0|0.01|0.4|||Cochran-Mantel-Haenszel|||Improvement Week 12, Under eye dark circles or bags: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645731|NCT01787461|3027103|Superiority or Other||Weighted Gamma Statistic|0.121||||0.445|2-Sided|95.0|-0.08|0.33|||Cochran-Mantel-Haenszel|||Improvement Week 12, Fine lines/wrinkles: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645732|NCT01787461|3027103|Superiority or Other||Weighted Gamma Statistic|0.083||||0.688|2-Sided|95.0|-0.1|0.27|||Cochran-Mantel-Haenszel|||Improvement Week 12, Overall appearance of facial skin: Analysis was performed using CMH test with modified ridit scores, controlling for Glogau Classification of Photoaging, site, and baseline.|
1645733|NCT01787461|3027104|Superiority or Other||LS Mean Difference|0.38||||0.027|2-Sided|95.0|0.04|0.72|||ANOVA|||Change at Week 24, Back of Hands - Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645734|NCT01787461|3027104|Superiority or Other||LS Mean Difference|0.04||||0.901|2-Sided|95.0|-0.31|0.38|||ANOVA|||Change at Week 24, Back of Hands- Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645735|NCT01787461|3027104|Superiority or Other||LS Mean Difference|0.05||||0.789|2-Sided|95.0|-0.29|0.38|||ANOVA|||Change at Week 24, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645736|NCT01787461|3027104|Superiority or Other||LS Mean Difference|0.03||||0.876|2-Sided|95.0|-0.33|0.38|||ANOVA|||Change at Week 24, Decolletage–Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645737|NCT01787461|3027104|Superiority or Other||LS Mean Difference|0.43||||0.005|2-Sided|95.0|0.13|0.73|||ANOVA|||Change at Week 12, Back of Hands-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645738|NCT01787461|3027104|Superiority or Other||LS Mean Difference|-0.03||||0.875|2-Sided|95.0|-0.38|0.32|||ANOVA|||Change at Week 12, Back of Hands–Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645739|NCT01787461|3027104|Superiority or Other||LS Mean Difference|0.14||||0.399|2-Sided|95.0|-0.19|0.47|||ANOVA|||Change at Week 12, Decolletage-Mottled Hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645740|NCT01787461|3027104|Superiority or Other||LS Mean Difference|0.02||||0.901|2-Sided|95.0|-0.33|0.37|||ANOVA|||Change at Week 12, Decolletage–Crepyness: Analysis was performed using an ANOVA model with treatment, Glogau cassification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645741|NCT01787461|3027105|Superiority or Other||LS Mean Difference|-0.02||||0.886|2-Sided|95.0|-0.35|0.3|||ANOVA|||Change at Week 24, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645742|NCT01787461|3027105|Superiority or Other||LS Mean Difference|-0.06||||0.684|2-Sided|95.0|-0.34|0.22|||ANOVA|||Change at Week 24, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645743|NCT01787461|3027105|Superiority or Other||LS Mean Difference|0.01||||0.954|2-Sided|95.0|-0.32|0.34|||ANOVA|||Change at Week 24, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645744|NCT01787461|3027105|Superiority or Other||LS Mean Difference|0.08||||0.669|2-Sided|95.0|-0.28|0.43|||ANOVA|||Change at Week 24, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645745|NCT01787461|3027105|Superiority or Other||LS Mean Difference|0.13||||0.356|2-Sided|95.0|-0.14|0.4|||ANOVA|||Change at Week 24, Fine lines/wrinkles(Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645746|NCT01787461|3027105|Superiority or Other||LS Mean Difference|0.1||||0.561|2-Sided|95.0|-0.23|0.43|||ANOVA|||Change at Week 24, Fine lines/wrinkles(Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645785|NCT01787188|3027153|Superiority or Other||Difference in Least Squares Mean|-8.44|Standard Error of the Mean|2.68||0.0018|2-Sided|95.0|-13.71|-3.17|||ANCOVA||||
1645747|NCT01787461|3027105|Superiority or Other||LS Mean Difference|0.08||||0.655|2-Sided|95.0|-0.27|0.43|||ANOVA|||Change at Week 12, Roughness/texture: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645748|NCT01787461|3027105|Superiority or Other||LS Mean Difference|-0.07||||0.672|2-Sided|95.0|-0.4|0.26|||ANOVA|||Change at Week 12, Sallowness/yellowing: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645749|NCT01787461|3027105|Superiority or Other||LS Mean Difference|-0.02||||0.915|2-Sided|95.0|-0.39|0.35|||ANOVA|||Change at Week 12, Mottled hyperpigmentation: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645750|NCT01787461|3027105|Superiority or Other||LS Mean Difference|-0.02||||0.916|2-Sided|95.0|-0.35|0.32|||ANOVA|||Change at Week 12, Under eye dark circles or bags: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645751|NCT01787461|3027105|Superiority or Other||LS Mean Difference|0.05||||0.674|2-Sided|95.0|-0.2|0.3|||ANOVA|||Change at Week 12, Fine lines/wrinkles (Perioral area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645752|NCT01787461|3027105|Superiority or Other||LS Mean Difference|0.01||||0.965|2-Sided|95.0|-0.29|0.3|||ANOVA|||Change at Week 12, Fine lines/wrinkles (Periocular area): Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645753|NCT01787461|3027106|Superiority or Other||LS Mean Difference|0.04||||0.797|2-Sided|95.0|-0.25|0.33|||ANOVA|||Change at Week 12: Analysis was performed using an ANOVA model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645754|NCT01787461|3027107|Superiority or Other||Weighted Gamma Statistic|0.037||||0.568|2-Sided|95.0|-0.19|0.27|||Cochran-Mantel-Haenszel|||Analysis was performed using Cochran-Mantel-Haenszel (CMH) test with modified ridit scores, controlling for Glogau classification of photoaging and site.|
1645755|NCT01787461|3027108|Superiority or Other||Least Squares (LS) Mean Difference|0.14||||0.358|2-Sided|95.0|-0.16|0.44|||ANOVA|||Change at Week 24: Analysis was performed using an analysis of variance (ANOVA) model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.|
1645756|NCT01787383|3027109|Superiority or Other|||||||0.66|||||||Wilcoxon (Mann-Whitney)||||
1645757|NCT01787383|3027110|Superiority or Other|||||||0.37|||||||Wilcoxon (Mann-Whitney)||||
1645758|NCT01787383|3027111|Superiority or Other|||||||0.033|||||||Wilcoxon (Mann-Whitney)||||
1645759|NCT01787383|3027112|Superiority or Other|||||||0.38|||||||Wilcoxon (Mann-Whitney)||||
1645760|NCT01787383|3027113|Superiority or Other|||||||0.2|||||||Wilcoxon (Mann-Whitney)||||
1645761|NCT01787383|3027114|Superiority or Other|||||||0.088|||||||Regression, Logistic||||
1645762|NCT01787383|3027115|Superiority or Other|||||||0.34|||||||Regression, Logistic||||
1645763|NCT01787383|3027116|Superiority or Other|||||||0.13|||||||Wilcoxon (Mann-Whitney)||||
1645764|NCT01787292|3027126|Superiority|||||||0.01|||||||t-test, 2 sided||||
1645765|NCT01787292|3027127|Superiority|||||||0.25|||||||t-test, 2 sided||||
1645766|NCT01787292|3027128|Superiority|||||||0.05|||||||t-test, 2 sided||||
1645767|NCT01787292|3027129|Superiority|||||||0.4|||||||t-test, 2 sided||||
1645768|NCT01787292|3027130|Superiority|||||||0.6|||||||t-test, 2 sided|A Kenward-Rogers adjustment for df was made to account for carryover effects.|||
1645769|NCT01787292|3027131|Superiority|||||||0.5|||||||t-test, 2 sided||||
1645770|NCT01787292|3027132|Superiority|||||||0.01|||||||t-test, 2 sided||||
1645771|NCT01787292|3027133|Superiority|||||||0.01|||||||t-test, 2 sided||||
1645772|NCT01787292|3027134|Superiority|||||||0.01|||||||t-test, 2 sided||||
1645773|NCT01787292|3027135|Superiority|||||||0.05||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|A Kenward-Rogers adjustment for degrees of freedom was made to account for carryover effects.|||
1645774|NCT01787292|3027136|Superiority|||||||0.05||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA||||
1645775|NCT01787292|3027137|Superiority|||||||0.8|||||||ANCOVA|||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|
1645776|NCT01787292|3027138|Superiority|||||||0.001||||||To account for sequence carryover, we employed analysis of covariance inclusive of sequence by period covariates against treatment effects.|ANCOVA|Least square means were adjusted for carryover from the crossover design and between subjects effects were analyzed using Kenward-Roger df estimation|||
1645777|NCT01787188|3027149|Superiority or Other||Difference in Least Squares Mean|-8.24|Standard Error of the Mean|2.795||0.0034|2-Sided|95.0|-13.74|-2.74|||ANCOVA||||
1645778|NCT01787188|3027149|Superiority or Other||Difference in Least Squares Mean|-11.67|Standard Error of the Mean|2.751|<|0.0001|2-Sided|95.0|-17.08|-6.26|||ANCOVA||||
1645779|NCT01787188|3027150|Superiority or Other||Difference in Least Squares Mean|-9.36|Standard Error of the Mean|3.422||0.0066|2-Sided|95.0|-16.09|-2.63|||Mixed Models Analysis||||
1645780|NCT01787188|3027150|Superiority or Other||Difference in Least Squares Mean|-10.94|Standard Error of the Mean|3.359||0.0012|2-Sided|95.0|-17.55|-4.33|||Mixed Models Analysis||||
1645781|NCT01787188|3027151|Superiority or Other||Difference in Least Squares Mean|-9.1|Standard Error of the Mean|3.21||0.0049|2-Sided|95.0|-15.41|-2.78|||Mixed Models Analysis||||
1645782|NCT01787188|3027151|Superiority or Other||Difference in Least Squares Mean|-12.22|Standard Error of the Mean|3.152||0.0001|2-Sided|95.0|-18.42|-6.02|||Mixed Models Analysis||||
1645783|NCT01787188|3027152|Superiority or Other||Difference in Least Squares Mean|-6.02|Standard Error of the Mean|2.89||0.0379|2-Sided|95.0|-11.71|-0.34|||Mixed Models Analysis||||
1645786|NCT01787188|3027153|Superiority or Other||Difference in Least Squares Mean|-10.52|Standard Error of the Mean|2.646|<|0.0001|2-Sided|95.0|-15.72|-5.31|||ANCOVA||||
1645787|NCT01787188|3027154|Superiority or Other||Difference in Least Squares Mean|-10.45|Standard Error of the Mean|3.24||0.0014|2-Sided|95.0|-16.82|-4.08|||Mixed Models Analysis||||
1645788|NCT01787188|3027154|Superiority or Other||Difference in Least Squares Mean|-10.26|Standard Error of the Mean|3.194||0.0014|2-Sided|95.0|-16.54|-3.97|||Mixed Models Analysis||||
1645789|NCT01787188|3027155|Superiority or Other||Difference in Least Squares Mean|-9.65|Standard Error of the Mean|3.006||0.0014|2-Sided|95.0|-15.56|-3.74|||Mixed Models Analysis||||
1645790|NCT01787188|3027155|Superiority or Other||Difference in Least Squares Mean|-9.68|Standard Error of the Mean|2.961||0.0012|2-Sided|95.0|-15.5|-3.85|||Mixed Models Analysis||||
1645791|NCT01787188|3027156|Superiority or Other||Difference in Least Squares Mean|-4.41|Standard Error of the Mean|2.725||0.1065|2-Sided|95.0|-9.77|0.95|||Mixed Models Analysis||||
1645792|NCT01787188|3027156|Superiority or Other||Difference in Least Squares Mean|-10.45|Standard Error of the Mean|2.686||0.0001|2-Sided|95.0|-15.73|-5.17|||Mixed Models Analysis||||
1645793|NCT01787188|3027157|Superiority or Other||Difference in Least Squares Mean|-8.16|Standard Error of the Mean|2.627||0.002|2-Sided|95.0|-13.33|-2.99|||ANCOVA||||
1645794|NCT01787188|3027157|Superiority or Other||Difference in Least Squares Mean|-10.47|Standard Error of the Mean|2.593|<|0.0001|2-Sided|95.0|-15.57|-5.37|||ANCOVA||||
1645795|NCT01787188|3027158|Superiority or Other||Difference in Least Squares Mean|-9.98|Standard Error of the Mean|3.198||0.0019|2-Sided|95.0|-16.27|-3.69|||Mixed Models Analysis||||
1645796|NCT01787188|3027158|Superiority or Other||Difference in Least Squares Mean|-10.13|Standard Error of the Mean|3.147||0.0014|2-Sided|95.0|-16.32|-3.94|||Mixed Models Analysis||||
1645797|NCT01787188|3027159|Superiority or Other||Difference in Least Squares Mean|-9.42|Standard Error of the Mean|2.951||0.0015|2-Sided|95.0|-15.22|-3.62|||Mixed Models Analysis||||
1645798|NCT01787188|3027159|Superiority or Other||Difference in Least Squares Mean|-9.83|Standard Error of the Mean|2.905||0.0008|2-Sided|95.0|-15.54|-4.11|||Mixed Models Analysis||||
1645799|NCT01787188|3027160|Superiority or Other||Difference in Least Squares Mean|-4.39|Standard Error of the Mean|2.662||0.0997|2-Sided|95.0|-9.63|0.84|||Mixed Models Analysis||||
1645800|NCT01787188|3027160|Superiority or Other||Difference in Least Squares Mean|-10.34|Standard Error of the Mean|2.623|<|0.0001|2-Sided|95.0|-15.49|-5.18|||Mixed Models Analysis||||
1645801|NCT01787188|3027161|Superiority or Other||Difference in Least Squares Mean|-7.82|Standard Error of the Mean|2.561||0.0024|2-Sided|95.0|-12.85|-2.78|||ANCOVA||||
1645802|NCT01787188|3027161|Superiority or Other||Difference in Least Squares Mean|-10.44|Standard Error of the Mean|2.521|<|0.0001|2-Sided|95.0|-15.4|-5.48|||ANCOVA||||
1645803|NCT01787188|3027162|Superiority or Other||Difference in Least Squares Mean|-9.84|Standard Error of the Mean|2.917||0.0008|2-Sided|95.0|-15.58|-4.1|||Mixed Models Analysis||||
1645804|NCT01787188|3027162|Superiority or Other||Difference in Least Squares Mean|-10.33|Standard Error of the Mean|2.865||0.0004|2-Sided|95.0|-15.97|-4.7|||Mixed Models Analysis||||
1645805|NCT01787188|3027163|Superiority or Other||Difference in Least Squares Mean|-3.9|Standard Error of the Mean|2.696||0.1486|2-Sided|95.0|-9.2|1.4|||Mixed Models Analysis||||
1645806|NCT01787188|3027163|Superiority or Other||Difference in Least Squares Mean|-9.61|Standard Error of the Mean|2.641||0.0003|2-Sided|95.0|-14.8|-4.42|||Mixed Models Analysis||||
1645807|NCT01787188|3027164|Superiority or Other||Difference in Least Squares Mean|-8.74|Standard Error of the Mean|3.154||0.0059|2-Sided|95.0|-14.94|-2.53|||Mixed Models Analysis||||
1645808|NCT01787188|3027164|Superiority or Other||Difference in Least Squares Mean|-10.84|Standard Error of the Mean|3.097||0.0005|2-Sided|95.0|-16.93|-4.75|||Mixed Models Analysis||||
1645809|NCT01787175|3027165|Superiority or Other||Odds Ratio (OR)|1.9||||0.005|2-Sided|95.0|1.22|2.98|||Regression, Logistic|||Null hypothesis: Participants will receive the same proportion of acceptable scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).|
1645810|NCT01787175|3027166|Superiority or Other||Value of problem scores for A&P complete|0.04||||0.15|2-Sided|95.0|-0.01|0.09|||Mixed-effects linear model|||Null hypothesis: Participants will receive the same scores for assessments and plans completed using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).|
1645811|NCT01787175|3027167|Superiority or Other||Difference in time to complete A&P|-17.73||||0.047|2-Sided|95.0|-35.24|-0.23|||Mixed-effects linear model|||Null hypothesis: Participants will require the same amount of time to complete assessments and plans using either IMM or CPRS. Power calculation: With 2 replications per subject, and assuming an ICC of 0.15, a two-sided alpha 0.05 comparison adjusted for 5 multiple comparisons (adjusted alpha = 0.01), and power of 80%, an N of 32 clinicians was required for each group (32 using IMM, and 32 using CPRS).|
1645812|NCT01787032|3027170|Superiority or Other||Ratio|266.56|Standard Deviation|16.0|||2-Sided|90.0|242.955|292.456|||||ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.||
1645813|NCT01787032|3027170|Superiority or Other||Ratio|372.88|Standard Deviation|13.1|||2-Sided|90.0|345.456|402.477|||||ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.||
1645814|NCT01787032|3027171|Superiority or Other||Ratio|213.39|Standard Deviation|34.1|||2-Sided|90.0|175.783|259.051|||||ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.||
1646096|NCT01783418|3027548|Superiority or Other|||||||0.97|||||||ANOVA|||Baseline, Post-intervention (8 weeks)|
1645815|NCT01787032|3027171|Superiority or Other||Ratio|261.34|Standard Deviation|37.3|||2-Sided|90.0|211.692|322.633|||||ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.||
1645816|NCT01787032|3027172|Superiority or Other||Ratio|266.94|Standard Deviation|16.0|||2-Sided|90.0|243.267|292.914|||||ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.||
1645817|NCT01787032|3027172|Superiority or Other||Ratio|373.66|Standard Deviation|13.2|||2-Sided|90.0|346.029|403.507|||||ANOVA model on the logarithmic scale: included effects accounting for following sources of variation: 'sequence', 'patients within sequence', 'period' and 'treatment'. Random effect: 'patients within sequences', others considered as fixed effects.||
1645818|NCT01786993|3027184|Non-Inferiority or Equivalence|Assuming a binomial distribution with a 44% probability for non-responders between 3 months and 9 months in both study arms, the sample size required for 85% power to reject the null hypothesis at the 5% significance level is 394. To adjust for a potential net crossover of 15% and an overall attrition rate of 20%, the total number of patients required to be enrolled in this study is 506.|Difference of proportions|-0.049||||0.0131|1-Sided|97.5|-0.138||||normal approximation for binomial dist|||"H0: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) – (Non-responder rate in the MPP arm between 3 M randomization and 9 M) ≤ -0.15~Ha: (Non-responder rate in the BiV arm between 3 M randomization and 9 M) – (Non-responder rate in the MPP arm between 3 M randomization and 9 M) > -0.15~The null hypothesis will be rejected at the 2.5% significance level if the lower one-sided 97.5% confidence bound for the difference in the proportions is above -0.15."|
1645819|NCT01786993|3027185|Superiority or Other||Event-Free Probability|0.932|||||2-Sided|95.0|0.904|0.951||||||"The hypothesis is formally expressed as:~H0: Freedom from system-related complications through 9 months ≤ 75% Ha: Freedom from system-related complications through 9 months > 75%"|
1645820|NCT01786967|3027186|Superiority||Risk Ratio (RR)|0.85||||1|2-Sided|95.0|0.76|0.95|||Fisher Exact|||Null hypothesis was that there was no difference in the rate of moderate to severe adverse events.|
1645821|NCT01786967|3027187|Superiority|This was a pilot study to provide preliminary data to inform future sample size estimates for a larger more definitive trial|Risk Ratio (RR)|0.96||||1|2-Sided|95.0|0.53|1.71|||Fisher Exact|||Null hypothesis was that there will be no difference in treatment benefit scale between the two groups|
1645822|NCT01786668|3027209|Superiority or Other||Mean Difference (Final Values)|4.51|Standard Error of the Mean|1.66||0.007|2-Sided|95.0|1.23|7.78|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645823|NCT01786668|3027209|Superiority or Other||Mean Difference (Final Values)|3.95|Standard Error of the Mean|1.642||0.017|2-Sided|95.0|0.71|7.19|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645824|NCT01786668|3027209|Superiority or Other||Mean Difference (Final Values)|1.66|Standard Error of the Mean|1.643||0.313|2-Sided|95.0|-1.58|4.9|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645825|NCT01786668|3027209|Superiority or Other||Mean Difference (Final Values)|1.34|Standard Error of the Mean|1.497||0.373|2-Sided|95.0|-1.62|4.29|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645826|NCT01786668|3027209|Superiority or Other||Mean Difference (Final Values)|1.96|Standard Error of the Mean|1.479||0.187|2-Sided|95.0|-0.96|4.87|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645827|NCT01786668|3027209|Superiority or Other||Mean Difference (Final Values)|1.69|Standard Error of the Mean|1.479||0.255|2-Sided|95.0|-1.23|4.61|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645828|NCT01786668|3027209|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|1.328||0.948|2-Sided|95.0|-2.53|2.7|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645829|NCT01786668|3027209|Superiority or Other||Mean Difference (Final Values)|0.96|Standard Error of the Mean|1.318||0.467|2-Sided|95.0|-1.64|3.56|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645830|NCT01786668|3027209|Superiority or Other||Mean Difference (Final Values)|1.54|Standard Error of the Mean|1.322||0.246|2-Sided|95.0|-1.07|4.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645831|NCT01786668|3027209|Superiority or Other||Mean Difference (Final Values)|0.27|Standard Error of the Mean|1.237||0.826|2-Sided|95.0|-2.17|2.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645832|NCT01786668|3027209|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|1.232||0.955|2-Sided|95.0|-2.36|2.5|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645833|NCT01786668|3027209|Superiority or Other||Mean Difference (Final Values)|1.72|Standard Error of the Mean|1.232||0.163|2-Sided|95.0|-0.71|4.15|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645834|NCT01786668|3027210|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.049||0.013|2-Sided|95.0|0.03|0.22|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.|||
1645835|NCT01786668|3027210|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.048||0.207|2-Sided|95.0|-0.03|0.16|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.|||
1645836|NCT01786668|3027210|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.048||0.125|2-Sided|95.0|-0.02|0.17|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.|||
1645837|NCT01786668|3027211|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|1.876||0.49|2-Sided|95.0|-2.4|5.0|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score|
1645838|NCT01786668|3027211|Superiority or Other||Mean Difference (Final Values)|1.73|Standard Error of the Mean|1.848||0.35|2-Sided|95.0|-1.91|5.37|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score|
1645839|NCT01786668|3027211|Superiority or Other||Mean Difference (Final Values)|-0.34|Standard Error of the Mean|1.857||0.857|2-Sided|95.0|-4.0|3.33|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Mental Health Score|
1645840|NCT01786668|3027211|Superiority or Other||Mean Difference (Final Values)|4.36|Standard Error of the Mean|1.328||0.001|2-Sided|95.0|1.74|6.98|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score|
1645841|NCT01786668|3027211|Superiority or Other||Mean Difference (Final Values)|3.8|Standard Error of the Mean|1.305||0.004|2-Sided|95.0|1.23|6.37|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score|
1645842|NCT01786668|3027211|Superiority or Other||Mean Difference (Final Values)|3.65|Standard Error of the Mean|1.312||0.006|2-Sided|95.0|1.06|6.24|||ANCOVA|ANCOVA model includes fixed effects for treatment group and baseline value as a covariate.||Physical Health Score|
1645843|NCT01786668|3027212|Superiority or Other||Mean Difference (Final Values)|-0.18|Standard Error of the Mean|0.271||0.515|2-Sided|95.0|-0.71|0.36|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645844|NCT01786668|3027212|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.269||0.491|2-Sided|95.0|-0.34|0.72|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645845|NCT01786668|3027212|Superiority or Other||Mean Difference (Final Values)|0.38|Standard Error of the Mean|0.269||0.155|2-Sided|95.0|-0.15|0.91|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645846|NCT01786668|3027212|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.257||0.964|2-Sided|95.0|-0.5|0.52|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645847|NCT01786668|3027212|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.254||0.397|2-Sided|95.0|-0.29|0.72|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645848|NCT01786668|3027212|Superiority or Other||Mean Difference (Final Values)|0.38|Standard Error of the Mean|0.254||0.134|2-Sided|95.0|-0.12|0.88|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645849|NCT01786668|3027212|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.233||0.278|2-Sided|95.0|-0.71|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645850|NCT01786668|3027212|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.231||0.288|2-Sided|95.0|-0.7|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645851|NCT01786668|3027212|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.232||0.482|2-Sided|95.0|-0.29|0.62|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645852|NCT01786668|3027212|Superiority or Other||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.204||0.175|2-Sided|95.0|-0.68|0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645853|NCT01786668|3027212|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.203||0.605|2-Sided|95.0|-0.3|0.51|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645854|NCT01786668|3027212|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.203||0.785|2-Sided|95.0|-0.34|0.46|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645855|NCT01786668|3027213|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.524||0.424|2-Sided|95.0|-1.45|0.61|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645856|NCT01786668|3027213|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.52||0.711|2-Sided|95.0|-0.83|1.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645857|NCT01786668|3027213|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.519||0.82|2-Sided|95.0|-0.91|1.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1646430|NCT01778127|3028059|Superiority or Other|||||||0.9|||||||t-test, 2 sided||||
1645858|NCT01786668|3027213|Superiority or Other||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|0.636||0.287|2-Sided|95.0|-1.93|0.57|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645859|NCT01786668|3027213|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.629||0.543|2-Sided|95.0|-1.63|0.86|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645860|NCT01786668|3027213|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.629||0.501|2-Sided|95.0|-1.66|0.82|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645861|NCT01786668|3027213|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.369||0.311|2-Sided|95.0|-1.1|0.35|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645862|NCT01786668|3027213|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.368||0.44|2-Sided|95.0|-0.44|1.01|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645863|NCT01786668|3027213|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.368||0.972|2-Sided|95.0|-0.74|0.71|||Mixed Models Analysis|||Week 4|
1645864|NCT01786668|3027213|Superiority or Other||Mean Difference (Final Values)|-0.77|Standard Error of the Mean|0.414||0.064|2-Sided|95.0|-1.59|0.05|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645865|NCT01786668|3027213|Superiority or Other||Mean Difference (Final Values)|0.66|Standard Error of the Mean|0.413||0.113|2-Sided|95.0|-0.16|1.47|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645866|NCT01786668|3027213|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.414||0.8|2-Sided|95.0|-0.92|0.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645867|NCT01786668|3027215|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.373||0.017|2-Sided|95.0|-1.64|-0.17|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645868|NCT01786668|3027215|Superiority or Other||Mean Difference (Final Values)|-1.04|Standard Error of the Mean|0.37||0.006|2-Sided|95.0|-1.77|-0.31|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645869|NCT01786668|3027215|Superiority or Other||Mean Difference (Final Values)|-0.33|Standard Error of the Mean|0.37||0.377|2-Sided|95.0|-1.06|0.4|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645870|NCT01786668|3027215|Superiority or Other||Mean Difference (Final Values)|-0.43|Standard Error of the Mean|0.415||0.297|2-Sided|95.0|-1.25|0.38|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645871|NCT01786668|3027215|Superiority or Other||Mean Difference (Final Values)|-0.65|Standard Error of the Mean|0.411||0.114|2-Sided|95.0|-1.46|0.16|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645872|NCT01786668|3027215|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.411||0.53|2-Sided|95.0|-1.07|0.55|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645873|NCT01786668|3027215|Superiority or Other||Mean Difference (Final Values)|-0.79|Standard Error of the Mean|0.388||0.044|2-Sided|95.0|-1.55|-0.02|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645874|NCT01786668|3027215|Superiority or Other||Mean Difference (Final Values)|-0.83|Standard Error of the Mean|0.386||0.033|2-Sided|95.0|-1.59|-0.07|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645875|NCT01786668|3027215|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.387||0.895|2-Sided|95.0|-0.81|0.71|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645876|NCT01786668|3027216|Superiority or Other||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.158||0.014|2-Sided|95.0|-0.7|-0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645877|NCT01786668|3027216|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.157||0.099|2-Sided|95.0|-0.57|0.05|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645878|NCT01786668|3027216|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.157||0.28|2-Sided|95.0|-0.48|0.14|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645879|NCT01786668|3027216|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.136||0.031|2-Sided|95.0|-0.56|-0.03|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1646431|NCT01778062|3028063|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1645880|NCT01786668|3027216|Superiority or Other||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.135||0.12|2-Sided|95.0|-0.48|0.06|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645881|NCT01786668|3027216|Superiority or Other||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.135||0.242|2-Sided|95.0|-0.42|0.11|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645882|NCT01786668|3027216|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.119||0.288|2-Sided|95.0|-0.36|0.11|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645883|NCT01786668|3027216|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.118||0.37|2-Sided|95.0|-0.34|0.13|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645884|NCT01786668|3027216|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.118||0.898|2-Sided|95.0|-0.25|0.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645885|NCT01786668|3027216|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.106||0.205|2-Sided|95.0|-0.34|0.07|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645886|NCT01786668|3027216|Superiority or Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.106||0.151|2-Sided|95.0|-0.36|0.06|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645887|NCT01786668|3027216|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.106||0.982|2-Sided|95.0|-0.21|0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645888|NCT01786668|3027217|Superiority or Other||Mean Difference (Final Values)|-0.81|Standard Error of the Mean|0.375||0.031|2-Sided|95.0|-1.55|-0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645889|NCT01786668|3027217|Superiority or Other||Mean Difference (Final Values)|-0.96|Standard Error of the Mean|0.372||0.011|2-Sided|95.0|-1.69|-0.22|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645890|NCT01786668|3027217|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.373||0.214|2-Sided|95.0|-1.2|0.27|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645891|NCT01786668|3027217|Superiority or Other||Mean Difference (Final Values)|-0.34|Standard Error of the Mean|0.352||0.337|2-Sided|95.0|-1.03|0.36|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645892|NCT01786668|3027217|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.35||0.05|2-Sided|95.0|-1.38|0.0|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645893|NCT01786668|3027217|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.35||0.522|2-Sided|95.0|-0.92|0.47|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645894|NCT01786668|3027217|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.297||0.318|2-Sided|95.0|-0.88|0.29|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645895|NCT01786668|3027217|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|0.296||0.048|2-Sided|95.0|-1.17|0.0|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645896|NCT01786668|3027217|Superiority or Other||Mean Difference (Final Values)|-0.34|Standard Error of the Mean|0.297||0.256|2-Sided|95.0|-0.92|0.25|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645897|NCT01786668|3027217|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.272||0.66|2-Sided|95.0|-0.66|0.42|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645898|NCT01786668|3027217|Superiority or Other||Mean Difference (Final Values)|-0.41|Standard Error of the Mean|0.271||0.129|2-Sided|95.0|-0.95|0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645899|NCT01786668|3027217|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.272||0.164|2-Sided|95.0|-0.92|0.16|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645900|NCT01786668|3027218|Superiority or Other||Risk Difference (RD)|18.78|Standard Error of the Mean|9.07||0.038|2-Sided|95.0|1.01|36.55|||Normal approximation for two proportions|||Week 12|
1645901|NCT01786668|3027218|Superiority or Other||Risk Difference (RD)|18.78|Standard Error of the Mean|9.07||0.038|2-Sided|95.0|1.01|36.55|||Normal approximation for two proportions|||Week 12|
1645902|NCT01786668|3027218|Superiority or Other||Risk Difference (RD)|22.62|Standard Error of the Mean|9.11||0.013|2-Sided|95.0|4.76|40.49|||Normal approximation for two proportions|||Week 12|
1645903|NCT01786668|3027218|Superiority or Other||Risk Difference (RD)|12.93|Standard Error of the Mean|9.24||0.162|2-Sided|95.0|-5.17|31.04|||Normal approximation for two proportions|||Week 8|
1645904|NCT01786668|3027218|Superiority or Other||Risk Difference (RD)|5.24|Standard Error of the Mean|9.02||0.561|2-Sided|95.0|-12.44|22.92|||Normal approximation for two proportions|||Week 8|
1645905|NCT01786668|3027218|Superiority or Other||Risk Difference (RD)|7.16|Standard Error of the Mean|9.09||0.43|2-Sided|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 8|
1645906|NCT01786668|3027218|Superiority or Other||Risk Difference (RD)|7.28|Standard Error of the Mean|8.52||0.393|2-Sided|95.0|-9.43|23.98|||Normal approximation for two proportions|||Week 4|
1645907|NCT01786668|3027218|Superiority or Other||Risk Difference (RD)|1.51|Standard Error of the Mean|8.2||0.854|2-Sided|95.0|-14.57|17.59|||Normal approximation for two proportions|||Week 4|
1645908|NCT01786668|3027218|Superiority or Other||Risk Difference (RD)|7.28|Standard Error of the Mean|8.52||0.393|2-Sided|95.0|-9.43|23.98|||Normal approximation for two proportions|||Week 4|
1645909|NCT01786668|3027218|Superiority or Other||Risk Difference (RD)|-2.22|Standard Error of the Mean|6.95||0.749|2-Sided|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2|
1645910|NCT01786668|3027218|Superiority or Other||Risk Difference (RD)|5.47|Standard Error of the Mean|7.62||0.473|2-Sided|95.0|-9.46|20.4|||Normal approximation for two proportions|||Week 2|
1645911|NCT01786668|3027218|Superiority or Other||Risk Difference (RD)|-4.15|Standard Error of the Mean|6.75||0.539|2-Sided|95.0|-17.38|9.08|||Normal approximation for two proportions|||Week 2|
1645912|NCT01786668|3027219|Superiority or Other||Mean Difference (Final Values)|-0.83|Standard Error of the Mean|0.399||0.038|2-Sided|95.0|-1.62|-0.04|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645913|NCT01786668|3027219|Superiority or Other||Mean Difference (Final Values)|-1.03|Standard Error of the Mean|0.396||0.01|2-Sided|95.0|-1.81|-0.24|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645914|NCT01786668|3027219|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.396||0.024|2-Sided|95.0|-1.69|-0.12|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645915|NCT01786668|3027219|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.383||0.217|2-Sided|95.0|-1.23|0.28|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645916|NCT01786668|3027219|Superiority or Other||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.38||0.174|2-Sided|95.0|-1.27|0.23|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645917|NCT01786668|3027219|Superiority or Other||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.381||0.445|2-Sided|95.0|-1.04|0.46|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645918|NCT01786668|3027219|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.343||0.474|2-Sided|95.0|-0.92|0.43|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645919|NCT01786668|3027219|Superiority or Other||Mean Difference (Final Values)|-0.33|Standard Error of the Mean|0.341||0.334|2-Sided|95.0|-1.0|0.34|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645920|NCT01786668|3027219|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.343||0.384|2-Sided|95.0|-0.97|0.38|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645921|NCT01786668|3027219|Superiority or Other||Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.31||0.57|2-Sided|95.0|-0.43|0.79|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645922|NCT01786668|3027219|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.308||0.718|2-Sided|95.0|-0.72|0.5|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645923|NCT01786668|3027219|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.31||0.926|2-Sided|95.0|-0.64|0.58|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645924|NCT01786668|3027220|Superiority or Other||Risk Difference (RD)|7.54|Standard Error of the Mean|6.26||0.228|2-Sided|95.0|-4.73|19.81|||Normal approximation for two proportions|||Week 12|
1645925|NCT01786668|3027220|Superiority or Other||Risk Difference (RD)|5.62|Standard Error of the Mean|6.05||0.353|2-Sided|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 12|
1645926|NCT01786668|3027220|Superiority or Other||Risk Difference (RD)|5.62|Standard Error of the Mean|6.05||0.353|2-Sided|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 12|
1645927|NCT01786668|3027220|Superiority or Other||Risk Difference (RD)|7.65|Standard Error of the Mean|4.53||0.091|2-Sided|95.0|-1.22|16.52|||Normal approximation for two proportions|||Week 8|
1645928|NCT01786668|3027220|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|2.72||0.989|2-Sided|95.0|-5.37|5.29|||Normal approximation for two proportions|||Week 8|
1645929|NCT01786668|3027220|Superiority or Other||Risk Difference (RD)|3.81|Standard Error of the Mean|3.77||0.313|2-Sided|95.0|-3.58|11.2|||Normal approximation for two proportions|||Week 8|
1645930|NCT01786668|3027220|Superiority or Other||Risk Difference (RD)|5.73|Standard Error of the Mean|4.17||0.17|2-Sided|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 4|
1645931|NCT01786668|3027220|Superiority or Other||Risk Difference (RD)|3.81|Standard Error of the Mean|3.77||0.313|2-Sided|95.0|-3.58|11.2|||Normal approximation for two proportions|||Week 4|
1645932|NCT01786668|3027220|Superiority or Other||Risk Difference (RD)|-0.04|Standard Error of the Mean|2.72||0.989|2-Sided|95.0|-5.37|5.29|||Normal approximation for two proportions|||Week 4|
1645933|NCT01786668|3027220|Superiority or Other||Risk Difference (RD)|1.92|Standard Error of the Mean|1.9||0.313|2-Sided|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2|
1645934|NCT01786668|3027220|Superiority or Other||Risk Difference (RD)|1.92|Standard Error of the Mean|1.9||0.313|2-Sided|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2|
1645935|NCT01786668|3027220|Superiority or Other||Risk Difference (RD)|1.92|Standard Error of the Mean|1.9||0.313|2-Sided|95.0|-1.81|5.66|||Normal approximation for two proportions|||Week 2|
1645936|NCT01786668|3027221|Superiority or Other||Risk Difference (RD)|13.24|Standard Error of the Mean|7.51||0.078|2-Sided|95.0|-1.49|27.96|||Normal approximation for two proportions|||Week 12|
1645937|NCT01786668|3027221|Superiority or Other||Risk Difference (RD)|11.31|Standard Error of the Mean|7.38||0.125|2-Sided|95.0|-3.16|25.78|||Normal approximation for two proportions|||Week 12|
1645938|NCT01786668|3027221|Superiority or Other||Risk Difference (RD)|7.47|Standard Error of the Mean|7.09||0.292|2-Sided|95.0|-6.42|21.36|||Normal approximation for two proportions|||Week 12|
1645939|NCT01786668|3027221|Superiority or Other||Risk Difference (RD)|13.27|Standard Error of the Mean|7.17||0.064|2-Sided|95.0|-0.79|27.34|||Normal approximation for two proportions|||Week 8|
1645940|NCT01786668|3027221|Superiority or Other||Risk Difference (RD)|17.12|Standard Error of the Mean|7.43||0.021|2-Sided|95.0|2.56|31.68|||Normal approximation for two proportions|||Week 8|
1645941|NCT01786668|3027221|Superiority or Other||Risk Difference (RD)|1.73|Standard Error of the Mean|6.08||0.775|2-Sided|95.0|-10.18|13.65|||Normal approximation for two proportions|||Week 8|
1645942|NCT01786668|3027221|Superiority or Other||Risk Difference (RD)|9.5|Standard Error of the Mean|5.99||0.113|2-Sided|95.0|-2.24|21.24|||Normal approximation for two proportions|||Week 4|
1645943|NCT01786668|3027221|Superiority or Other||Risk Difference (RD)|5.66|Standard Error of the Mean|5.52||0.306|2-Sided|95.0|-5.17|16.48|||Normal approximation for two proportions|||Week 4|
1645944|NCT01786668|3027221|Superiority or Other||Risk Difference (RD)|5.66|Standard Error of the Mean|5.52||0.306|2-Sided|95.0|-5.17|16.48|||Normal approximation for two proportions|||Week 4|
1645945|NCT01786668|3027221|Superiority or Other||Risk Difference (RD)|5.73|Standard Error of the Mean|4.17||0.17|2-Sided|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2|
1645946|NCT01786668|3027221|Superiority or Other||Risk Difference (RD)|5.73|Standard Error of the Mean|4.17||0.17|2-Sided|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2|
1645947|NCT01786668|3027221|Superiority or Other||Risk Difference (RD)|5.73|Standard Error of the Mean|4.17||0.17|2-Sided|95.0|-2.45|13.91|||Normal approximation for two proportions|||Week 2|
1645948|NCT01786668|3027222|Superiority or Other||Risk Difference (RD)|28.32|Standard Error of the Mean|9.3||0.002|2-Sided|95.0|10.09|46.55|||Normal approximation for two proportions|||Week 12|
1645949|NCT01786668|3027222|Superiority or Other||Risk Difference (RD)|36.01|Standard Error of the Mean|9.15|<|0.001|2-Sided|95.0|18.09|53.94|||Normal approximation for two proportions|||Week 12|
1645950|NCT01786668|3027222|Superiority or Other||Risk Difference (RD)|24.47|Standard Error of the Mean|9.33|<|0.009|2-Sided|95.0|6.18|42.76|||Normal approximation for two proportions|||Week 12|
1645951|NCT01786668|3027222|Superiority or Other||Risk Difference (RD)|30.2|Standard Error of the Mean|9.33|<|0.001|2-Sided|95.0|11.92|48.49|||Normal approximation for two proportions|||Week 8|
1645952|NCT01786668|3027222|Superiority or Other||Risk Difference (RD)|30.2|Standard Error of the Mean|9.33|<|0.001|2-Sided|95.0|11.92|48.49|||Normal approximation for two proportions|||Week 8|
1645953|NCT01786668|3027222|Superiority or Other||Risk Difference (RD)|14.82|Standard Error of the Mean|9.39|<|0.114|2-Sided|95.0|-3.58|33.22|||Normal approximation for two proportions|||Week 8|
1645954|NCT01786668|3027222|Superiority or Other||Risk Difference (RD)|32.32|Standard Error of the Mean|8.88|<|0.001|2-Sided|95.0|14.9|49.73|||Normal approximation for two proportions|||Week 4|
1645955|NCT01786668|3027222|Superiority or Other||Risk Difference (RD)|38.08|Standard Error of the Mean|8.82|<|0.001|2-Sided|95.0|20.79|55.38|||Normal approximation for two proportions|||Week 4|
1645956|NCT01786668|3027222|Superiority or Other||Risk Difference (RD)|22.7|Standard Error of the Mean|8.82|<|0.01|2-Sided|95.0|5.41|39.99|||Normal approximation for two proportions|||Week 4|
1645957|NCT01786668|3027222|Superiority or Other||Risk Difference (RD)|24.7|Standard Error of the Mean|8.5|<|0.004|2-Sided|95.0|8.04|41.36|||Normal approximation for two proportions|||Week 2|
1645958|NCT01786668|3027222|Superiority or Other||Risk Difference (RD)|32.39|Standard Error of the Mean|8.6|<|0.001|2-Sided|95.0|15.54|49.24|||Normal approximation for two proportions|||Week 2|
1645959|NCT01786668|3027222|Superiority or Other||Risk Difference (RD)|11.24|Standard Error of the Mean|7.99|<|0.159|2-Sided|95.0|-4.41|26.89|||Normal approximation for two proportions|||Week 2|
1645960|NCT01786668|3027223|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.172|<|0.001|2-Sided|95.0|-1.03|-0.35|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645961|NCT01786668|3027223|Superiority or Other||Mean Difference (Final Values)|-0.73|Standard Error of the Mean|0.171|<|0.001|2-Sided|95.0|-1.07|-0.39|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645962|NCT01786668|3027223|Superiority or Other||Mean Difference (Final Values)|-0.55|Standard Error of the Mean|0.171|<|0.002|2-Sided|95.0|-0.89|-0.21|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 12|
1645963|NCT01786668|3027223|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|0.159|<|0.001|2-Sided|95.0|-0.9|-0.27|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645964|NCT01786668|3027223|Superiority or Other||Mean Difference (Final Values)|-0.63|Standard Error of the Mean|0.157|<|0.001|2-Sided|95.0|-0.94|-0.32|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645965|NCT01786668|3027223|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.158|<|0.026|2-Sided|95.0|-0.66|-0.04|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 8|
1645966|NCT01786668|3027223|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|0.141|<|0.001|2-Sided|95.0|-0.86|-0.31|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645967|NCT01786668|3027223|Superiority or Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.141|<|0.001|2-Sided|95.0|-0.9|-0.34|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645968|NCT01786668|3027223|Superiority or Other||Mean Difference (Final Values)|-0.43|Standard Error of the Mean|0.141|<|0.003|2-Sided|95.0|-0.7|-0.15|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 4|
1645969|NCT01786668|3027223|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.136|<|0.001|2-Sided|95.0|-0.74|-0.2|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645970|NCT01786668|3027223|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.136|<|0.001|2-Sided|95.0|-0.77|-0.24|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645971|NCT01786668|3027223|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.136|<|0.175|2-Sided|95.0|-0.46|0.08|||Mixed Models Analysis|Includes fixed effects of treatment group, visit, and treatment-group by-visit interaction and baseline value, using an unstructured covariance matrix||Week 2|
1645972|NCT01786668|3027224|Superiority or Other||Risk Difference (RD)|22.78|Standard Error of the Mean|8.45||0.007|2-Sided|95.0|6.21|39.34|||Normal approximation for two proportions|||Week 12|
1645973|NCT01786668|3027224|Superiority or Other||Risk Difference (RD)|34.31|Standard Error of the Mean|8.6|<|0.001|2-Sided|95.0|17.45|51.18|||Normal approximation for two proportions|||Week 12|
1645974|NCT01786668|3027224|Superiority or Other||Risk Difference (RD)|3.54|Standard Error of the Mean|7.47|<|0.635|2-Sided|95.0|-11.1|18.19|||Normal approximation for two proportions|||Week 12|
1645975|NCT01786668|3027224|Superiority or Other||Risk Difference (RD)|19.04|Standard Error of the Mean|7.54|<|0.012|2-Sided|95.0|4.27|33.81|||Normal approximation for two proportions|||Week 8|
1645976|NCT01786668|3027224|Superiority or Other||Risk Difference (RD)|32.5|Standard Error of the Mean|8.02|<|0.001|2-Sided|95.0|16.79|48.22|||Normal approximation for two proportions|||Week 8|
1645977|NCT01786668|3027224|Superiority or Other||Risk Difference (RD)|11.35|Standard Error of the Mean|7.03|<|0.106|2-Sided|95.0|-2.43|25.13|||Normal approximation for two proportions|||Week 8|
1645978|NCT01786668|3027224|Superiority or Other||Risk Difference (RD)|21.0|Standard Error of the Mean|7.32|<|0.004|2-Sided|95.0|6.65|35.36|||Normal approximation for two proportions|||Week 4|
1645979|NCT01786668|3027224|Superiority or Other||Risk Difference (RD)|22.93|Standard Error of the Mean|7.43|<|0.002|2-Sided|95.0|8.37|37.48|||Normal approximation for two proportions|||Week 4|
1645980|NCT01786668|3027224|Superiority or Other||Risk Difference (RD)|11.39|Standard Error of the Mean|6.64|<|0.086|2-Sided|95.0|-1.62|24.39|||Normal approximation for two proportions|||Week 4|
1645981|NCT01786668|3027224|Superiority or Other||Risk Difference (RD)|13.31|Standard Error of the Mean|6.8|<|0.05|2-Sided|95.0|-0.02|26.64|||Normal approximation for two proportions|||Week 2|
1645982|NCT01786668|3027224|Superiority or Other||Risk Difference (RD)|5.62|Standard Error of the Mean|6.05|<|0.353|2-Sided|95.0|-6.23|17.47|||Normal approximation for two proportions|||Week 2|
1645983|NCT01786668|3027224|Superiority or Other||Risk Difference (RD)|15.23|Standard Error of the Mean|6.95|<|0.028|2-Sided|95.0|1.61|28.86|||Normal approximation for two proportions|||Week 2|
1645984|NCT01786668|3027225|Superiority or Other||Risk Difference (RD)|18.85|Standard Error of the Mean|8.74||0.031|2-Sided|95.0|1.72|35.99|||Normal approximation for two proportions|||Week 12|
1645985|NCT01786668|3027225|Superiority or Other||Risk Difference (RD)|26.55|Standard Error of the Mean|8.87||0.003|2-Sided|95.0|9.16|43.93|||Normal approximation for two proportions|||Week 12|
1645986|NCT01786668|3027225|Superiority or Other||Risk Difference (RD)|22.7|Standard Error of the Mean|8.82||0.01|2-Sided|95.0|5.41|39.99|||Normal approximation for two proportions|||Week 12|
1645987|NCT01786668|3027225|Superiority or Other||Risk Difference (RD)|9.09|Standard Error of the Mean|9.15||0.32|2-Sided|95.0|-8.84|27.01|||Normal approximation for two proportions|||Week 8|
1645988|NCT01786668|3027225|Superiority or Other||Risk Difference (RD)|7.16|Standard Error of the Mean|9.09||0.43|2-Sided|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 8|
1645989|NCT01786668|3027225|Superiority or Other||Risk Difference (RD)|1.4|Standard Error of the Mean|8.86||0.875|2-Sided|95.0|-15.97|18.76|||Normal approximation for two proportions|||Week 8|
1645990|NCT01786668|3027225|Superiority or Other||Risk Difference (RD)|5.47|Standard Error of the Mean|7.62||0.473|2-Sided|95.0|-9.46|20.4|||Normal approximation for two proportions|||Week 4|
1645991|NCT01786668|3027225|Superiority or Other||Risk Difference (RD)|17.01|Standard Error of the Mean|8.26||0.04|2-Sided|95.0|0.81|33.2|||Normal approximation for two proportions|||Week 4|
1645992|NCT01786668|3027225|Superiority or Other||Risk Difference (RD)|13.16|Standard Error of the Mean|8.09||0.104|2-Sided|95.0|-2.69|29.01|||Normal approximation for two proportions|||Week 4|
1645993|NCT01786668|3027225|Superiority or Other||Risk Difference (RD)|1.62|Standard Error of the Mean|7.31||0.824|2-Sided|95.0|-12.71|15.95|||Normal approximation for two proportions|||Week 2|
1646097|NCT01783418|3027549|Superiority or Other|||||||0.256|||||||ANOVA|||Baseline, Post-intervention (8 weeks)|
1645994|NCT01786668|3027225|Superiority or Other||Risk Difference (RD)|-2.22|Standard Error of the Mean|6.95||0.749|2-Sided|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2|
1645995|NCT01786668|3027225|Superiority or Other||Risk Difference (RD)|-2.22|Standard Error of the Mean|6.95||0.749|2-Sided|95.0|-15.85|11.4|||Normal approximation for two proportions|||Week 2|
1645996|NCT01786668|3027226|Superiority or Other||Mean Difference (Final Values)|-1.71|Standard Error of the Mean|0.523||0.001|2-Sided|95.0|-2.75|-0.68|||ANCOVA||||
1645997|NCT01786668|3027226|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|0.52|<|0.001|2-Sided|95.0|-2.83|-0.78|||ANCOVA||||
1645998|NCT01786668|3027226|Superiority or Other||Mean Difference (Final Values)|-0.64|Standard Error of the Mean|0.52|<|0.221|2-Sided|95.0|-1.66|0.39|||ANCOVA||||
1645999|NCT01786668|3027227|Superiority or Other||Mean Difference (Final Values)|-6.47|Standard Error of the Mean|1.525|<|0.001|2-Sided|95.0|-9.48|-3.46|||ANCOVA||||
1646000|NCT01786668|3027227|Superiority or Other||Mean Difference (Final Values)|-5.42|Standard Error of the Mean|1.52|<|0.001|2-Sided|95.0|-8.42|-2.42|||ANCOVA||||
1646001|NCT01786668|3027227|Superiority or Other||Mean Difference (Final Values)|-3.0|Standard Error of the Mean|1.517|<|0.05|2-Sided|95.0|-5.99|0.0|||ANCOVA||||
1646002|NCT01786668|3027228|Superiority or Other||Mean Difference (Final Values)|-2.74|Standard Error of the Mean|1.131||0.016|2-Sided|95.0|-4.97|-0.51|||ANCOVA||||
1646003|NCT01786668|3027228|Superiority or Other||Mean Difference (Final Values)|-2.35|Standard Error of the Mean|1.13||0.039|2-Sided|95.0|-4.58|-0.12|||ANCOVA||||
1646004|NCT01786668|3027228|Superiority or Other||Mean Difference (Final Values)|-0.89|Standard Error of the Mean|1.123||0.427|2-Sided|95.0|-3.11|1.32|||ANCOVA||||
1646005|NCT01786668|3027229|Superiority or Other||Risk Difference (RD)|10.71|Standard Error of the Mean|9.79||0.274|2-Sided|95.0|-8.48|29.9|||Normal approximation for two proportions|||Week 8|
1646006|NCT01786668|3027229|Superiority or Other||Risk Difference (RD)|28.02|Standard Error of the Mean|9.36||0.003|2-Sided|95.0|9.68|46.36|||Normal approximation for two proportions|||Week 8|
1646007|NCT01786668|3027229|Superiority or Other||Risk Difference (RD)|14.56|Standard Error of the Mean|9.75||0.135|2-Sided|95.0|-4.55|33.66|||Normal approximation for two proportions|||Week 8|
1646008|NCT01786668|3027229|Superiority or Other||Risk Difference (RD)|14.74|Standard Error of the Mean|9.57||0.123|2-Sided|95.0|-4.01|33.5|||Normal approximation for two proportions|||Week 4|
1646009|NCT01786668|3027229|Superiority or Other||Risk Difference (RD)|22.44|Standard Error of the Mean|9.54||0.019|2-Sided|95.0|3.74|41.13|||Normal approximation for two proportions|||Week 4|
1646010|NCT01786668|3027229|Superiority or Other||Risk Difference (RD)|14.74|Standard Error of the Mean|9.57||0.123|2-Sided|95.0|-4.01|33.5|||Normal approximation for two proportions|||Week 4|
1646011|NCT01786668|3027229|Superiority or Other||Risk Difference (RD)|7.16|Standard Error of the Mean|9.09||0.43|2-Sided|95.0|-10.65|24.97|||Normal approximation for two proportions|||Week 2|
1646012|NCT01786668|3027229|Superiority or Other||Risk Difference (RD)|5.24|Standard Error of the Mean|9.02||0.561|2-Sided|95.0|-12.44|22.92|||Normal approximation for two proportions|||Week 2|
1646013|NCT01786668|3027229|Superiority or Other||Risk Difference (RD)|12.93|Standard Error of the Mean|9.24||0.162|2-Sided|95.0|-5.17|31.04|||Normal approximation for two proportions|||Week 2|
1646014|NCT01786668|3027230|Superiority or Other||Risk Difference (RD)|14.59|Standard Error of the Mean|9.74||0.134|2-Sided|95.0|-4.5|33.69|||Normal approximation for two proportions||||
1646015|NCT01786668|3027230|Superiority or Other||Risk Difference (RD)|39.59|Standard Error of the Mean|8.8|<|0.001|2-Sided|95.0|22.35|56.83|||Normal approximation for two proportions||||
1646016|NCT01786668|3027230|Superiority or Other||Risk Difference (RD)|10.75|Standard Error of the Mean|9.77|<|0.271|2-Sided|95.0|-8.41|29.9|||Normal approximation for two proportions||||
1646017|NCT01786668|3027231|Superiority or Other||Risk Difference (RD)|27.3|||||2-Sided|95.0|10.7|43.4||||||Emax model - 95% Confidence Interval represents 95% Credible Interval|
1646018|NCT01786668|3027231|Superiority or Other||Risk Difference (RD)|22.9|||||2-Sided|95.0|8.4|37.7||||||Emax model - 95% Confidence Interval represents 95% Credible Interval|
1646019|NCT01786668|3027231|Superiority or Other||Risk Difference (RD)|15.8|||||2-Sided|95.0|5.0|30.3||||||Emax model - 95% Confidence Interval represents 95% Credible Interval|
1646020|NCT01786252|3027250|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1646021|NCT01786252|3027251|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1646022|NCT01786252|3027252|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1646023|NCT01786252|3027253|Superiority or Other||||||>|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular dating between hCG and IVF media groups.|
1646024|NCT01786252|3027253|Superiority or Other||||||<|0.01|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare stromal staging between hCG and IVF media group.|
1646025|NCT01786252|3027253|Superiority or Other||||||>|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular and stromal dating within the hCG group.|
1646026|NCT01786252|3027253|Superiority or Other||||||<|0.05|||||||ANOVA|Sidak-multiple comparison test was performed to detect significant differences between groups.||Statistical analysis to compare differences between endometrial glandular and stromal dating within the vehicle group.|
1646027|NCT01786239|3027254|Superiority or Other|||||||0.0493|||||||Mixed Models Analysis||||
1646028|NCT01786174|3027261|Superiority or Other||Slope|4.27|Standard Error of the Mean|4.04||0.294|2-Sided|95.0|-3.78|12.33|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4|
1646029|NCT01786174|3027263|Superiority or Other||Slope|-0.51|Standard Error of the Mean|2.26||0.823|2-Sided|95.0|-5.0|3.99|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4|
1646030|NCT01786174|3027264|Superiority or Other||Slope|0.25|Standard Error of the Mean|0.89||0.78|2-Sided|95.0|-1.53|2.03|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4|
1646098|NCT01783418|3027550|Superiority or Other|||||||0.957|||||||ANOVA|||Baseline, Post-intervention (8 weeks)|
1646031|NCT01786174|3027265|Superiority or Other||Slope|1.4|Standard Error of the Mean|4.3||0.746|2-Sided|95.0|-7.17|9.96|||Random slopes model|||Fingolimod vs. Placebo Weeks 0-4|
1646032|NCT01785849|3027297|Superiority or Other||Mean Difference|-7.45|Standard Error of the Mean|2.47||0.003|2-Sided|95.0|-12.31|-2.59|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo||
1646033|NCT01785849|3027298|Superiority or Other||Mean Difference|-14.99|Standard Error of the Mean|2.41|<|0.001|2-Sided|95.0|-19.73|-10.25|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo||
1646034|NCT01785849|3027299|Superiority or Other||Mean Difference|-8.38|Standard Error of the Mean|0.58|<|0.001|2-Sided|95.0|-9.52|-7.23|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo||
1646035|NCT01785849|3027300|Superiority or Other||Mean Difference|-71.11|Standard Error of the Mean|3.39|<|0.001|2-Sided|95.0|-77.77|-64.46|||Repeated Measures Mixed Effects Model|Repeated measures mixed-effects model included treatment, stratification factors, visit, and treatment by visit interaction as covariates.|Etelcalcetide - Placebo||
1646036|NCT01785849|3027301|Superiority or Other||Odds Ratio (OR)|22.08|||<|0.001|2-Sided|95.0|11.47|42.48|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by screening PTH category, recent cinacalcet use within 8 weeks before randomization, and region.|||
1646037|NCT01785849|3027302|Superiority or Other||Odds Ratio (OR)|32.46|||<|0.001|2-Sided|95.0|18.71|56.31|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel test stratified by screening PTH category (< 600, ≥ 600 to ≤ 1000, and > 1000 pg/mL), recent cinacalcet use within 8 weeks before randomization (yes and no), and region (North America and non-North America) was used to compare the primary endpoint of proportion of participants with > 30% reduction from baseline in PTH during the EAP between etelcalcetide and placebo.|
1646038|NCT01785472|3027370|Non-Inferiority or Equivalence|The statistical test was made at a one-sided significance level of 0.025.|least Square Means net difference|-2.33|Standard Error of the Mean|0.85|<|0.001||95.0|-4.0|-0.66|||ANCOVA||||
1646039|NCT01785160|3027385|Non-Inferiority or Equivalence|Relative bioavailability(No formal testing was performed)|Adjusted Geometric Mean ratio|245.72|Standard Deviation|87.1||0.9973||95.0|168.46|358.404||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Raltegravir plus Faldaprevir and Raltegravir for the category Raltegravir|
1646040|NCT01785160|3027386|Non-Inferiority or Equivalence|Relative bioavailability (No formal testing was performed)|Adjusted Geometric Mean ratio|272.06|Standard Deviation|67.9||0.9999||95.0|199.69|370.66||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Raltegravir plus Faldaprevir and Raltegravir for the category Raltegravir|
1646041|NCT01784965|3027404|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1646042|NCT01784614|3027442|Superiority or Other||Ratio of Geometric LS mean|0.3|||<|0.001|2-Sided|90.0|0.18|0.51|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 6.0 mg LY2624803 / Placebo.||
1646043|NCT01784614|3027442|Superiority or Other||Ratio of Geometric LS mean|0.53|||<|0.01|2-Sided|90.0|0.36|0.78|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 3.0 mg LY2624803 / Placebo.||
1646044|NCT01784614|3027442|Superiority or Other||Ratio of Geometric LS mean|0.67|||<|0.083|2-Sided|90.0|0.45|0.98|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 1.0 mg LY2624803 / Placebo.||
1646045|NCT01784614|3027442|Superiority or Other||Ratio of Geometric LS mean|0.96|||<|0.908|2-Sided|90.0|0.56|1.65|||Mixed Models Analysis||Ratio of Geometric LS mean is WASO of 0.1 mg LY2624803 / Placebo.||
1646046|NCT01784588|3027443|Non-Inferiority|Non-inferiority (NI) was demonstrated if the entire confidence interval was above -15% at 36 months. The sample size was estimated under the assumption that the proportion of subjects with treatment success is 85% for each of Solyx and Obtryx. For a (one-sided) type I error rate of 0.05, 194 subjects (97 per arm) are needed to have 90% power to demonstrate non-inferiority of Solyx with a NI margin of 15%.|Unadjusted Treatment Difference (%)|1.5|||||2-Sided|90.0|-5.4|8.4||||||Available Cases Only - Intent-to-Treat|
1646047|NCT01784588|3027443|Non-Inferiority|Non-inferiority (NI) was demonstrated if the entire confidence interval was above -15% at 36 months. The sample size was estimated under the assumption that the proportion of subjects with treatment success is 85% for each of Solyx and Obtryx. For a (one-sided) type I error rate of 0.05, 194 subjects (97 per arm) are needed to have 90% power to demonstrate non-inferiority of Solyx with a NI margin of 15%.|Adjusted Difference in Percentages|-0.4|||||2-Sided|90.0|-8.2|7.4||||||Available Cases Only - Intent-to-Treat|
1646048|NCT01783886|3027456|Superiority or Other||Mean Difference (Final Values)|8.01||||0.0009|2-Sided|97.5|2.64|13.37|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.||
1646049|NCT01783886|3027456|Superiority or Other||Mean Difference (Final Values)|2.81||||0.2688|2-Sided|97.5|-2.9|8.53|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.||
1646050|NCT01783886|3027457|Superiority or Other||Mean Difference (Final Values)|6.87||||0.0113|2-Sided|97.5|0.8|12.94|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.||
1646051|NCT01783886|3027457|Superiority or Other||Mean Difference (Final Values)|5.78||||0.0364|2-Sided|97.5|-0.41|11.97|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.||
1646052|NCT01783886|3027458|Superiority or Other||Mean Difference (Final Values)|-131.4|||<|0.0001|2-Sided|97.5|-172.8|-89.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.||
1646053|NCT01783886|3027458|Superiority or Other||Median Difference (Final Values)|-130.5|||<|0.0001|2-Sided|97.5|-171.2|-89.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.||
1646054|NCT01783886|3027459|Superiority or Other||CMH adjusted difference|40.6|||<|0.0001|2-Sided|97.5|27.6|53.7|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.||
1646099|NCT01783418|3027551|Superiority or Other|||||||0.613|||||||ANOVA|||Baseline and Post-intervention (8 weeks)|
1646055|NCT01783886|3027459|Superiority or Other||CMH adjusted difference|39.1|||<|0.0001|2-Sided|97.5|26.0|52.2|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.||
1646056|NCT01783886|3027460|Superiority or Other||CMH adjusted difference|24.3|||<|0.0001|2-Sided|97.5|12.6|35.9|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.||
1646057|NCT01783886|3027460|Superiority or Other||CMH adjusted difference|31.1|||<|0.0001|2-Sided|97.5|19.2|43.0|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.||
1646058|NCT01783886|3027461|Superiority or Other||CMH adjusted difference|39.2|||<|0.0001|2-Sided|97.5|26.3|52.1|||Cochran-Mantel-Haenszel||The estimate is calculated as EYLEA minus Laser.||
1646059|NCT01783886|3027461|Superiority or Other||CMH adjusted difference|47.4|||<|0.0001|2-Sided|97.5|35.0|59.9|||Cochran-Mantel-Haenszel||Cochran-Mantel-Haenszel (CMH). The estimate is calculated as EYLEA minus Laser.||
1646060|NCT01783886|3027462|Superiority or Other||Mean Difference (Final Values)|13.6|||<|0.0001|2-Sided|97.5|10.2|16.9|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.||
1646061|NCT01783886|3027462|Superiority or Other||Mean Difference (Final Values)|14.1|||<|0.0001|2-Sided|97.5|10.9|17.2|||ANCOVA||Least Square (LS) mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser.||
1646062|NCT01783860|3027463|Superiority or Other|||||||0.08|||||||t-test, 1 sided||||
1646063|NCT01783860|3027464|Superiority or Other|||||||0.02|||||||t-test, 1 sided||||
1646064|NCT01783860|3027465|Superiority or Other||||||>|0.05|||||||t-test, 1 sided||||
1646065|NCT01783860|3027466|Superiority or Other|||||||0.007|||||||t-test, 1 sided||||
1646066|NCT01783860|3027467|Superiority or Other|||||||0.01|||||||t-test, 1 sided||||
1646067|NCT01783860|3027468|Superiority or Other|||||||0.03|||||||t-test, 1 sided||||
1646068|NCT01783821|3027471|Superiority or Other|||||||0.01|||||||Kruskal-Wallis||||
1646069|NCT01783821|3027472|Superiority or Other|||||||0.02|||||||Cox Proportional Hazard, Fine/Gray adj.||||
1646070|NCT01783821|3027473|Superiority or Other|||||||0.01|||||||Fisher Exact||||
1646071|NCT01783821|3027474|Superiority or Other|||||||0.01|||||||Chi-squared||||
1646072|NCT01783821|3027475|Superiority or Other|||||||0.01|||||||Fisher Exact|||Comparison between the two arms for the 3 categories.|
1646073|NCT01783821|3027476|Superiority or Other|||||||0.02|||||||Type 3 Wald Test|||Overall p-value of the day by treatment interaction from the random effects model using a type 3 Wald test.|
1646074|NCT01783548|3027520|Superiority or Other||LSM treatment difference from placebo|-0.54||||0.004|2-Sided|95.0|-0.91|-0.17||a priori statistical significance is <0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.|||
1646075|NCT01783548|3027521|Superiority or Other||LSM treatment difference from placebo|-0.62||||0.002|2-Sided|95.0|-1.0|-0.23||a priori statistical significance is <0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.|||
1646076|NCT01783548|3027522|Superiority or Other||LSM treatment difference from placebo|-0.58||||0.004|2-Sided|95.0|-0.99|-0.18||a priori statistical significance is <0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.|||
1646077|NCT01783548|3027523|Superiority or Other||LSM treatment difference from placebo|-0.66||||0.002|2-Sided|95.0|-1.08|-0.24||a priori statistical significance is <0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||Based on other studies, the standard deviation for the change from baseline over the first 6 weeks of treatment in the average of AM and PM rTNSS is assumed to be 2.0. Using this standard deviation, 450 subjects aged 6 to 11 years (300 on active treatment of BDP and 150 on placebo) provide approximately 90% power to detect a difference of 0.65 in rTNSS change from baseline between treatment groups with a two-sided alpha level of 0.05.|
1646078|NCT01783483|3027531|Superiority or Other|||||||0.113|||||||t-test, 2 sided|||From 3 month to 6-month post op|
1646079|NCT01783483|3027533|Superiority or Other|||||||0.055|||||||t-test, 2 sided|||From 3-week to 6-week post-op|
1646080|NCT01783483|3027534|Superiority or Other|||||||0.778|||||||t-test, 2 sided|||From Hospital Discharge to 3-week|
1646081|NCT01783483|3027535|Superiority or Other|||||||0.37|||||||t-test, 2 sided|||Index (Day 0 to Hospital Discharge)|
1646082|NCT01783483|3027537|Superiority or Other|||||||0.2295|||||||t-test, 2 sided|||After Forced Coughing|
1646083|NCT01783483|3027537|Superiority or Other|||||||0.6653|||||||t-test, 2 sided|||At Rest|
1646084|NCT01783483|3027538|Superiority or Other|||||||0.0183|||||||t-test, 2 sided|||After Forced Coughing|
1646085|NCT01783483|3027538|Superiority or Other|||||||0.0049|||||||t-test, 2 sided|||At Rest|
1646086|NCT01783483|3027539|Superiority or Other|||||||0.0014|||||||t-test, 2 sided|||After Forced Coughing|
1646087|NCT01783483|3027539|Superiority or Other|||||||0.2125|||||||t-test, 2 sided|||At Rest|
1646088|NCT01783483|3027540|Superiority or Other|||||||0.0015|||||||t-test, 2 sided|||After Forced Coughing|
1646089|NCT01783483|3027540|Superiority or Other|||||||0.0539|||||||t-test, 2 sided|||At Rest|
1646090|NCT01783483|3027541|Superiority or Other|||||||0.0007|||||||t-test, 2 sided||||
1646091|NCT01783483|3027542|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Comparison of mean CT scan scores.|
1646092|NCT01783470|3027544|Equivalence|All p values presented are two tailed. p values < 0.05 were considered to indicate statistical significance for the primary outcome.||||||0.001|||||||Wilcoxon sign-ranks test|||Since the sample size of twelve subjects limited the ability to demonstrate that measurements were normally distributed, we used the non-parametric Wilcoxon sign-ranks test to assess the primary and secondary endpoints. All p values presented are two tailed. p values < 0.05 were considered to indicate statistical significance for the primary outcome.|
1646093|NCT01783418|3027545|Superiority or Other|||||||0.95|||||||ANOVA|||Baseline, Post-intervention (8 weeks)|
1646094|NCT01783418|3027546|Superiority or Other|||||||0.358|||||||ANOVA|||Baseline, Post-intervention (8 weeks)|
1646095|NCT01783418|3027547|Superiority or Other|||||||0.241|||||||ANOVA|||Baseline, Post-intervention|
1646101|NCT01783080|3027560|Superiority or Other||Mean Difference (Final Values)|13.4||||0.005|2-Sided||||||Regression, Linear||||
1646102|NCT01782898|3027602|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)||||
1646103|NCT01782898|3027603|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1646104|NCT01782898|3027604|Superiority or Other|||||||0.82|||||||Wilcoxon (Mann-Whitney)||||
1646105|NCT01782742|3027626|Superiority or Other||Mean Difference (Final Values)|0.01||||0.53|2-Sided|95.0|-0.02|0.04|||t-test, 2 sided||||
1646106|NCT01782742|3027627|Superiority or Other||Mean Difference (Final Values)|0.006||||0.46|2-Sided|95.0|-0.01|0.021|||t-test, 2 sided||||
1646107|NCT01782742|3027635|Superiority or Other||Mean Difference (Final Values)|4.563||||0.18|2-Sided|95.0|-1.975|11.1|||t-test, 2 sided||||
1646108|NCT01782742|3027636|Superiority or Other||Mean Difference (Final Values)|-0.375||||0.94|2-Sided|95.0|-9.674|8.924|||t-test, 2 sided||||
1646109|NCT01782742|3027637|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|0.0|0.0|||||||
1646110|NCT01782742|3027638|Superiority or Other||Mean Difference (Final Values)|0.625||||0.83|2-Sided|95.0|-5.029|6.279|||t-test, 2 sided||||
1646111|NCT01782742|3027639|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.57|2-Sided|95.0|-4.428|2.428|||t-test, 2 sided||||
1646112|NCT01782742|3027640|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.22|2-Sided|95.0|-0.13|0.03|||t-test, 2 sided||||
1646113|NCT01782690|3027653|Superiority or Other|||||||0.2361|||||||Log Rank|||Comparison of Rash=Yes versus Rash=No within Erlotinib plus Gemcitabine arm|
1646114|NCT01782469|3027685|Superiority or Other|||||||0.003||||||Mean number of joints with erosions at Vist 5 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test||||
1646115|NCT01782469|3027685|Superiority or Other|||||||0.006||||||Mean number of joints with erosions at Vist 4 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test||||
1646116|NCT01782469|3027685|Superiority or Other|||||||0.031||||||Mean number of joints with erosions at Vist 3 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test||||
1646117|NCT01782469|3027685|Superiority or Other|||||||0.13||||||Mean number of joints with erosions at Vist 2 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test||||
1646118|NCT01782469|3027686|Superiority or Other|||||||0.001||||||Mean percent reduction in ultrasonography assessment score at Vist 5 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test||||
1646119|NCT01782469|3027686|Superiority or Other||||||<|0.001||||||Mean percent reduction in ultrasonography assessment score at Vist 4 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test||||
1646120|NCT01782469|3027686|Superiority or Other||||||<|0.001||||||Mean percent reduction in ultrasonography assessment score at Vist 3 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test||||
1646121|NCT01782469|3027686|Superiority or Other||||||<|0.001||||||Mean percent reduction in ultrasonography assessment score at Vist 2 as compared to Baseline (Visit 1)|Wilcoxon signed-rank test||||
1646122|NCT01782378|3027688|Superiority||Mean Difference (Final Values)|-0.73|Standard Error of the Mean|0.94|<|0.44|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646123|NCT01782378|3027689|Superiority||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.73|<|0.85|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646124|NCT01782378|3027690|Superiority||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.86|<|0.71|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results|||
1646125|NCT01782378|3027691|Superiority||Mean Difference (Final Values)|1.12|Standard Error of the Mean|0.84|<|0.2|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646126|NCT01782378|3027692|Superiority||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.88|<|0.82|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646127|NCT01782378|3027693|Superiority||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.19|<|0.36|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646128|NCT01782378|3027694|Superiority||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.16|<|0.02|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646129|NCT01782378|3027695|Superiority||Mean Difference (Final Values)|0.36|Standard Error of the Mean|0.5|<|0.48|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results|||
1646130|NCT01782378|3027696|Superiority||Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.83|<|0.7|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646131|NCT01782378|3027697|Superiority||Mean Difference (Final Values)|3.36|Standard Error of the Mean|1.86||0.08|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results|||
1646132|NCT01782378|3027698|Superiority||Mean Difference (Final Values)|0.91|Standard Error of the Mean|0.62|<|0.15|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results|||
1646133|NCT01782378|3027699|Superiority||Mean Difference (Final Values)|-1.98|Standard Error of the Mean|2.53|<|0.43|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results|||
1646134|NCT01782378|3027700|Superiority||Mean Difference (Final Values)|0.38|Standard Error of the Mean|1.63|<|0.82|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results|||
1646135|NCT01782378|3027701|Superiority||Mean Difference (Final Values)|-0.66|Standard Error of the Mean|1.44|<|0.64|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646136|NCT01782378|3027702|Superiority||Mean Difference (Final Values)|0.87|Standard Error of the Mean|1.18|<|0.46|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646137|NCT01782378|3027703|Superiority||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|1.7|<|0.45|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646138|NCT01782378|3027704|Superiority|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|Mean Difference (Final Values)|-14.43|Standard Error of the Mean|12.54|<|0.26|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results that were considered credible.|||
1646139|NCT01782378|3027705|Superiority||Mean Difference (Final Values)|0.56|Standard Error of the Mean|3.02|<|0.85|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646140|NCT01782378|3027706|Superiority||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.75|<|0.93|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646141|NCT01782378|3027707|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.83|<|0.84|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646142|NCT01782378|3027708|Superiority||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.68|<|0.46|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results|||
1646143|NCT01782378|3027709|Superiority||Mean Difference (Final Values)|-0.73|Standard Error of the Mean|0.78|<|0.36|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646144|NCT01782378|3027710|Superiority||Mean Difference (Final Values)|-2.06|Standard Error of the Mean|2.26|<|0.37|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646145|NCT01782378|3027711|Superiority||Mean Difference (Final Values)|3.92|Standard Error of the Mean|3.51|<|0.27|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646146|NCT01782378|3027712|Superiority||Mean Difference (Final Values)|-1.93|Standard Error of the Mean|2.93|<|0.52|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646147|NCT01782378|3027713|Superiority||Mean Difference (Final Values)|11.39|Standard Error of the Mean|7.08|<|0.12|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646148|NCT01782378|3027714|Superiority||Mean Difference (Final Values)|3.52|Standard Error of the Mean|2.88||0.23|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results|||
1646149|NCT01782378|3027715|Superiority||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.59||0.81|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646177|NCT01781975|3027768|Superiority||ANCOVA|0.0616|Standard Error of the Mean|0.0364||0.048|2-Sided|90.0|0.00176|0.121|||ANCOVA||||
1646459|NCT01777269|3028324|Superiority or Other||Adjusted mean difference|-1.27|||<|0.006|2-Sided|95.0|-2.19|-0.36|||mixed-model repeated-measures||Month 3||
1646150|NCT01782378|3027716|Superiority||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.88||0.88|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results.|||
1646151|NCT01782378|3027717|Superiority||Mean Difference (Final Values)|-0.55|Standard Error of the Mean|0.33|<|0.01|2-Sided|||||without adjustment for multiple comparisons Mixed effects model with the assumption that 'subject factor' was a random effect. p-value threshold of p<.10|ANOVA|Adjusted for baseline scores; co-variate adjustments did not affect any of the results|||
1646152|NCT01782326|3027734|Superiority or Other||Hazard Ratio (HR)|0.89||||0.79|2-Sided|95.0|0.38|2.1|||Regression, Cox||||
1646153|NCT01782326|3027735|Superiority or Other||Hazard Ratio (HR)|0.81||||0.046|2-Sided|95.0|0.66|1.0|||Regression, Cox||||
1646154|NCT01782326|3027736|Superiority or Other||Hazard Ratio (HR)|0.81||||0.008|2-Sided|95.0|0.69|0.95|||Regression, Cox||||
1646155|NCT01782326|3027737|Superiority or Other||Hazard Ratio (HR)|0.9||||0.256|2-Sided|95.0|0.74|1.08|||Regression, Cox||||
1646156|NCT01782326|3027742|Superiority or Other||Hazard Ratio (HR)|0.78|||<|0.001|2-Sided|95.0|0.7|0.86|||Regression, Cox||||
1646157|NCT01782326|3027743|Superiority or Other||Rate Ratio|0.83|||<|0.001|2-Sided|95.0|0.75|0.91|||Generalized linear model||||
1646158|NCT01782326|3027744|Superiority or Other||Hazard Ratio (HR)|0.84|||<|0.001|2-Sided|95.0|0.78|0.91|||Regression, Cox||||
1646159|NCT01782326|3027745|Superiority or Other||Rate Ratio|0.89||||0.003|2-Sided|95.0|0.83|0.96|||Generalized linear method||If non-inferiority was demonstrated, superiority of QVA149A compared to SFC in reducing exacerbation rate could be claimed if the upper limit of the same CI was less than 1.||
1646160|NCT01782326|3027745|Non-Inferiority or Equivalence|Study was designed to have >95% power to rule out a 1.15-fold increase in the rate exacerbations for QVA149 vs. salmeterol/fluticasone.|Rate Ratio|0.89|||||2-Sided|95.0|0.83|0.96|||||If the upper limit of the confidence interval was <1.15 then non-inferiority of QVA149 compared to SFC could be claimed||
1646161|NCT01782222|3027755|Superiority or Other||Least Square Mean|-4.83|Standard Error of the Mean|1.92||0.013|2-Sided|95.0|-8.63|-1.03|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646162|NCT01782222|3027755|Superiority or Other||Least Square Mean|-4.96|Standard Error of the Mean|1.99||0.014|2-Sided|95.0|-8.91|-1.01|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646163|NCT01782222|3027756|Superiority or Other||Least Square Mean|-0.33|Standard Error of the Mean|1.19||0.785|2-Sided|95.0|-2.68|2.03|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646164|NCT01782222|3027756|Superiority or Other||Least Square Mean|0.16|Standard Error of the Mean|1.26||0.899|2-Sided|95.0|-2.34|2.66|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646165|NCT01782222|3027757|Superiority or Other||Least Square Mean|0.02|Standard Error of the Mean|0.38||0.968|2-Sided|95.0|-0.74|0.77|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646166|NCT01782222|3027757|Superiority or Other||Least Square Mean|-0.38|Standard Error of the Mean|0.39||0.334|2-Sided|95.0|-1.16|0.4|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646167|NCT01782222|3027758|Superiority or Other||Least Square Mean|-3.88|Standard Error of the Mean|1.8||0.034|2-Sided|95.0|-7.46|-0.3|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646168|NCT01782222|3027758|Superiority or Other||Least Square Mean|-3.62|Standard Error of the Mean|1.9||0.06|2-Sided|95.0|-7.39|0.15|||ANCOVA|ANCOVA model for the change from Baseline to End of Treatment containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646169|NCT01782222|3027759|Superiority or Other||Least Square Mean|-5.06|Standard Error of the Mean|3.15||0.111|2-Sided|95.0|-11.29|1.17|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646170|NCT01782222|3027759|Superiority or Other||Least Square Mean|-2.09|Standard Error of the Mean|3.23||0.519|2-Sided|95.0|-8.48|4.31|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646171|NCT01782222|3027760|Superiority or Other||Least Square Mean|-3.04|Standard Error of the Mean|2.55||0.239|2-Sided|95.0|-8.19|2.1|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646172|NCT01782222|3027760|Superiority or Other||Least Square Mean|-3.2|Standard Error of the Mean|2.46||0.2|2-Sided|95.0|-8.17|1.76|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646173|NCT01782222|3027761|Superiority or Other||Least Square Mean|-6.06|Standard Error of the Mean|2.45||0.015|2-Sided|95.0|-10.9|-1.21|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646174|NCT01782222|3027761|Superiority or Other||Least Square Mean|-7.29|Standard Error of the Mean|2.53||0.005|2-Sided|95.0|-12.3|-2.28|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646175|NCT01782222|3027762|Superiority or Other||Least Square Mean|-0.22|Standard Error of the Mean|1.21||0.859|2-Sided|95.0|-2.61|2.18|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646176|NCT01782222|3027762|Superiority or Other||Least Square Mean|0.04|Standard Error of the Mean|1.24||0.977|2-Sided|95.0|-2.42|2.5|||ANCOVA|ANCOVA model for the change from Baseline to End of Maintenance containing treatment and disease stage as factors, and Baseline value as covariate.|||
1646178|NCT01781481|3027780|Superiority or Other||R2Change|0.07|||<|0.01|2-Sided||||||Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.|
1646179|NCT01781481|3027781|Superiority or Other||R2Change|0.03|||<|0.05|2-Sided|||||Threshold for statistical significance is p <0.05.|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of ER Visits. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.|
1646180|NCT01781481|3027782|Superiority or Other||Rsquare change statistic|0.05|||<|0.01|2-Sided|||||p<.05 threshold for statistical significance|Regression, Linear|Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of extra appointments with the IBD team. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3).|
1646181|NCT01781481|3027783|Superiority or Other||R2Change|0.05|||<|0.01|2-Sided|||||Threshold for statistical significance is p<0.01|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of calls to the IBD Nurse. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.|
1646182|NCT01781481|3027784|Superiority or Other||Rsquare change statistic|0.08|||<|0.01|2-Sided|||||p<0.05 Threshold for statistical significance|Regression, Linear|||A hierarchical multiple (linear) regression analysis was conducted to determine the predictive relation between the Pediatric INTERMED indicator of case complexity and the number of hospital services involved in child's care. Gender, and time since diagnosis were entered as covariates (Step 1), followed by current disease severity (Step 2) and the Pediatric INTERMED Complexity Index (Step 3). Diagnostic tests for collinearity were conducted and all assumptions for the analysis were met.|
1646183|NCT01781481|3027785|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Family Financial Well-Being."|
1646184|NCT01781481|3027785|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Surgeries since Child's IBD Diagnosis."|
1646185|NCT01781481|3027785|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospitalizations since Child's IBD Diagnosis. Services Involved in the Child's Care."|
1646186|NCT01781481|3027785|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Health System Impediments Item (vulnerability/health system) and Number of Hospital Services Involved in the Child's Care."|
1646187|NCT01781481|3027785|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Family Financial Well Being."|
1646188|NCT01781481|3027785|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Surgeries Child's IBD Diagnosis."|
1646189|NCT01781481|3027785|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospitalizations since Child's IBD Diagnosis."|
1646190|NCT01781481|3027785|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Coordination of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care."|
1646191|NCT01781481|3027785|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Family Financial Well-Being."|
1646192|NCT01781481|3027785|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Surgeries since Child's IBD Diagnosis."|
1646193|NCT01781481|3027785|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospitalizations since IBD Diagnosis."|
1646194|NCT01781481|3027785|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Organization of Care Item (current/health system) and Number of Hospital Services Involved in the Child's Care."|
1646195|NCT01781481|3027785|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Family Financial Well-Being."|
1646196|NCT01781481|3027785|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Surgeries since child's diagnosis."|
1646460|NCT01777269|3028324|Superiority or Other||Adjusted mean difference|-0.55|||<|0.24|2-Sided|95.0|-1.47|0.37|||mixed-model repeated-measures||Month 1||
1646197|NCT01781481|3027785|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis."|
1646198|NCT01781481|3027785|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Treatment Experience Item (historical/health system) and Number of Hospital Services Involved in the Child's Care."|
1646199|NCT01781481|3027785|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Family Financial Well-Being."|
1646200|NCT01781481|3027785|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Surgeries since Diagnosis."|
1646201|NCT01781481|3027785|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospitalizations since Child's IBD Diagnosis."|
1646202|NCT01781481|3027785|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Access to Health Care Item (historical/health system) and Number of Hospital Services Involved in the Child's Care."|
1646203|NCT01781481|3027785|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Family Financial Well Being|
1646204|NCT01781481|3027785|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Surgeries since IBD diagnosis.|
1646205|NCT01781481|3027785|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Inpatient Hospitalizations since IBD diagnosis.|
1646206|NCT01781481|3027785|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Health System Domain Score (health system needs/complexity) and Number of Hospital Services involved in the child's care.|
1646207|NCT01781481|3027786|Superiority or Other||Odds Ratio (OR)|24.79|||||2-Sided|95.0|5.0|122.84|||||||
1646208|NCT01781481|3027787|Superiority or Other||Odds Ratio (OR)|7.27|||||2-Sided|95.0|2.17|24.36|||||||
1646209|NCT01781481|3027788|Superiority or Other||Odds Ratio (OR)|8.52|||||2-Sided|95.0|1.7|43.02|||||||
1646210|NCT01781481|3027789|Superiority or Other||Odds Ratio (OR)|8.33|||||2-Sided|95.0|2.02|34.47|||||||
1646211|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Family Inventory of Resources for Management (family resources measure).|
1646212|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).|
1646213|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).|
1646214|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Impact Quality of Life: Social Scale|
1646215|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Academic Competence Scale (Child Behaviour Checklist).|
1646216|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Activities Competence Scale (Child Behaviour Checklist).|
1646217|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Social Competence Scale (Child Behaviour Checklist).|
1646218|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale|
1646219|NCT01781481|3027790|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Multidimensional Anxiety Scale for Children: Total Score.|
1646220|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Children's Depression Inventory: Total Score|
1646221|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Externalizing Problems (Child Behaviour Checklist).|
1646222|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Caregiver/Family Domain Score (caregiver/family needs) and Internalizing Problems (Child Behaviour Checklist).|
1646223|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Resources for Management (family resources measure).|
1646224|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Family Inventory of Life Events (family stress measure).|
1646225|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).|
1646226|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Social Scale|
1646227|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Academic Competence Scale (Child Behaviour Checklist).|
1646228|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Activities Competence Scale (Child Behaviour Checklist).|
1646229|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Social Competence Scale (Child Behaviour Checklist).|
1646230|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Impact Quality of Life: Emotional Scale|
1646231|NCT01781481|3027790|Superiority or Other||||||<|0.05||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Multidimensional Anxiety Scale for Children: Total Score.|
1646232|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Children's Depression Inventory: Total Score|
1646233|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Externalizing Problems (Child Behaviour Checklist).|
1646234|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Social Domain Score (social needs) and Internalizing Problems (Child Behaviour Checklist).|
1646235|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Resources for Management (family resources measure).|
1646236|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Family Inventory of Life Events (family stress measure).|
1646237|NCT01781481|3027790|Superiority or Other||||||<|0.05||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Pediatric Inventory for Parents: Difficulty Score (parenting stress).|
1646238|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Social Scale|
1646239|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Academic Competence Scale (Child Behaviour Checklist).|
1646240|NCT01781481|3027790|Superiority or Other||||||<|0.05||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Activities Competence Scale (Child Behaviour Checklist).|
1646241|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Social Competence Scale (Child Behaviour Checklist).|
1646242|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Impact Quality of Life: Emotional Scale|
1646243|NCT01781481|3027790|Superiority or Other||||||<|0.05||||||The threshold for significance is p<0.05|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Multidimensional Anxiety Scale for Children: Total Score.|
1646244|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Children's Depression Inventory: Total Score|
1646245|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Externalizing Problems (Child Behaviour Checklist).|
1646246|NCT01781481|3027790|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological Domain Score (psychological needs) and Internalizing Problems (Child Behaviour Checklist).|
1646247|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of anti-TNFa Medications."|
1646248|NCT01781481|3027791|Superiority or Other||||||<|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Use of Immunomodulators (azathioprine or methotrexate)."|
1646461|NCT01777269|3028324|Superiority or Other||Adjusted mean difference|-1.65|||<|0.001|2-Sided|95.0|-2.45|-0.85|||mixed-model repeated-measures||Week 2||
1646249|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Courses of Prednisone."|
1646250|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Number of Surgeries."|
1646251|NCT01781481|3027791|Superiority or Other||||||<|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Impact Quality of Life: General Well Being Scale."|
1646252|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.01.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (parent rating)."|
1646253|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Functional Disability Index (Child Rating)."|
1646254|NCT01781481|3027791|Superiority or Other||||||<|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at study participation."|
1646255|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Complications and Life Threat Item (Vulnerability Biological) and Disease Severity at diagnosis."|
1646256|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The Threshold for significance is p<0.05)|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of ant-TNFa Medications (infliximab or adalimumab)."|
1646257|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The threshold for significiance is p<0.01.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Use of Immunomodulators (azathioprine or methotrexate)."|
1646258|NCT01781481|3027791|Superiority or Other||||||<|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Courses of Prednisone since diagnosis."|
1646259|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Number of Surgeries."|
1646260|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Impact Quality of Life: General Well-Being"|
1646261|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Parent Rating)"|
1646262|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Functional Disability Index (Child Rating)."|
1646263|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview)."|
1646264|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Therapeutic Complexity Item (Current Biological) and Disease Severity at Diagnosis."|
1646265|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of anti-TNFa Medications"|
1646266|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Use of Immunomodulators. ."|
1646267|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Courses of Prednisone."|
1646268|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Number of Surgeries."|
1646269|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Impact Quality of LIfe: General Well-Being Scale"|
1646270|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (parent rating)."|
1646271|NCT01781481|3027791|Superiority or Other||||||<|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and Functional Disability Index (Child Rating)"|
1646272|NCT01781481|3027791|Superiority or Other||||||<|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at time of study participation."|
1646273|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Diagnostic/Therapeutic Challenge Item (Current Biological) and IBD Disease Severity at Diagnosis."|
1646709|NCT01769469|3029096|Other|||||||0.2927|||||||Wilcoxon (Mann-Whitney)||||
1646274|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05. The P-Value indicated above was found for all the correlations which were examined.|Spearman Correlation Coefficient|||"Correlations between Pediatric INTERMED Diagnostic Dilemma Item (Historical Biological) and Functional Disability Index (Parent) and each of the following variables: Disease Severity at Diagnosis, Disease Severity at Interview, Functional Disability Index - Child, Functional Disability Index- Parent, Impact Quality of Life: General Well Being, Number of Surgeries, Number of Courses of Prednisone, Use of Immunomodulators, Use of Anti-TNFa Medications."|
1646275|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of anti-TNFa Medications."|
1646276|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Use of Immunomodulators."|
1646277|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Courses of Prednisone."|
1646278|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Number of Surgeries"|
1646279|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Impact Quality of Life: General Well-Being Scale"|
1646280|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (Parent Rating)"|
1646281|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and Functional Disability Index (child rating)."|
1646282|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current Biological) and IBD Disease Severity at time of study participation."|
1646283|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||"Correlation between Pediatric INTERMED Symptom Severity Item (Current/Biological) and Disease Severity at Diagnosis."|
1646284|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and use of anti-TNFa medications.|
1646285|NCT01781481|3027791|Superiority or Other||||||<|0.05||||||The threshold for significance is p< 0.05.|Spearman Correlation Coefficent|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Use of Immunomodulators (azathioprine or methotrexate)|
1646286|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Courses of Prednisone.|
1646287|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Number of Surgeries.|
1646288|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Impact Quality of Life: General Well-Being.|
1646289|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Parent)|
1646290|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Functional Disability Index (Child Report)|
1646291|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at time of study participation (Pediatric INTERMED interview).|
1646292|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Chronicity Item (Historical Biological) and Disease Severity at Diagnosis.|
1646293|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Use of ant-TNFa medications.|
1646294|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Spearman Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Use of Immunomodulators.|
1646295|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Number of Courses of Prednisone.|
1646296|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Number of Surgeries.|
1646297|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Impact Quality of Life: General Well Being scale.|
1646298|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The threshold for significance is p<.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (parent rating).|
1646299|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The threshold for significance is p< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and Functional Disability Index (child rating).|
1646300|NCT01781481|3027791|Superiority or Other||||||<|0.01||||||The threshold for significance is p< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity (at time of Study Participation).|
1646301|NCT01781481|3027791|Superiority or Other||||||>|0.05||||||The threshold for significance is p<0.05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Biological Domain Score and IBD Disease Severity at Diagnosis|
1646302|NCT01781481|3027805|Superiority or Other||||||<|0.01||||||The threshold for significance is p< .05.|Pearson Correlation Coefficient|||Correlation between Family/Caregiver and Health Service Pediatric INTERMED domain scores.|
1646303|NCT01781481|3027805|Superiority or Other||||||<|0.01||||||The threshold for significance is p< .05.|Pearson Correlation Coefficient|||Correlation between Social and Health Service Pediatric INTERMED domain scores.|
1646304|NCT01781481|3027805|Superiority or Other||||||<|0.01||||||The threshold for significance is p< .05.|Pearson Correlation Coefficient|||Correlation between Social and Family/Caregiver Pediatric INTERMED domain scores.|
1646305|NCT01781481|3027805|Superiority or Other||||||<|0.01||||||The threshold for significance is p< .05.|Pearson Correlation Coefficient|||Correlation between Pediatric INTERMED Psychological and Health Service Pediatric INTERMED domain scores.|
1646306|NCT01781481|3027805|Superiority or Other||||||<|0.01||||||The threshold for significance is p< .05.|Pearson Correlation Coefficient||||
1646307|NCT01781481|3027805|Superiority or Other||||||<|0.01||||||The threshold for significance is p< .05.|Pearson Correlation Coefficient|||Correlation between Psychology and Social Pediatric INTERMED domain scores.|
1646308|NCT01781481|3027805|Superiority or Other||||||<|0.01||||||The threshold for significance is p< .05.|Pearson Correlation Coefficient|||Correlation between Biological and Health Service Pediatric INTERMED domain scores.|
1646309|NCT01781481|3027805|Superiority or Other||||||<|0.01||||||The threshold for significance is p< .05.|Pearson Correlation Coefficient|||Correlation between the Biological and Family/Caregiver Pediatric INTERMED domain scores.|
1646310|NCT01781481|3027805|Superiority or Other||||||<|0.01||||||The threshold for significance is p< .05.|Pearson Correlation Coefficient|||Correlation between the Biological and Social domain scores on the Pediatric INTERMED.|
1646311|NCT01781481|3027805|Superiority or Other||||||<|0.05||||||Correlation between the biological and psychological domain scores on the Pediatric INTERMED. The threshold for significance is p< .05.|Pearson Correlation Coefficients||||
1646312|NCT01781481|3027806|Superiority or Other||Cronbach's Alpha|0.91|||||2-Sided||||||||Overall internal consistency of the overall Pediatric INTERMED scale (34 items).||
1646313|NCT01781481|3027806|Superiority or Other||Inter-rater reliability|0.87|||||2-Sided||||||||Inter rater reliability for a subset of 40 patients whose Pediatric INTERMED was scored by two trained raters. The median inter-rater reliability coefficient was .87.||
1646314|NCT01781468|3027808|Superiority|||||||0.8559|||||||Kruskal-Wallis|||Baseline to Week 8|
1646315|NCT01781468|3027808|Superiority|||||||0.9122|||||||Kruskal-Wallis|||Baseline to Week 4|
1646316|NCT01781468|3027809|Superiority|||||||0.3272|||||||Kruskal-Wallis||||
1646317|NCT01781468|3027810|Superiority|||||||0.7877|||||||Fisher Exact||||
1646318|NCT01781468|3027811|Superiority|||||||0.9601|||||||Fisher Exact||||
1646319|NCT01781208|3027833|Superiority or Other||||||<|0.0001||||||r=0.73, unadjusted for age, gender, and histologic inflammation score|Pearson Correlation|||Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTIQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.|
1646320|NCT01781208|3027833|Superiority or Other||||||<|0.0001||||||r=0.68, unadjusted for age, gender, and histologic inflammation.|Pearson Correlation|||Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.|
1646321|NCT01781078|3027836|Non-Inferiority|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|0.0||||0.0002|1-Sided|95.0||4.7|||Farrington-Manning score test||||
1646322|NCT01781078|3027836|Non-Inferiority|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|-0.1||||0.0006|1-Sided|95.0||5.0|||Farrington-Manning score test||||
1646323|NCT01781078|3027837|Non-Inferiority|The difference in the success rate between the 2 randomized groups was compared to 10% using a one-sided Farrington-Manning score test for non-inferiority at a significance level of 0.05.|difference|-0.3|||<|0.0001|1-Sided|95.0||3.9|||Farrington-Manning score test||||
1646324|NCT01780584|3027889|Superiority or Other||Median Difference (Final Values)|10.0||||0.06||95.0|5.0|15.0|||Kruskal-Wallis|||Null hypothesis: there is no difference of postoperative hospital length of stay between groups. Statistical power 80% and level of significance 0.05.|
1646325|NCT01780584|3027890|Superiority or Other||Median Difference (Net)|50.0||||0.4||95.0|40.0|60.0|||Kruskal-Wallis|||Null hypothesis: there is no difference of length of stay in Intensive Care Unit. Statistical power 80% and level of significance 0.05.|
1646326|NCT01780584|3027891|Superiority or Other||Median Difference (Final Values)|5.0||||0.31||95.0|3.0|10.0||Kruskal Wallis test was used to determine any difference of time of extubation between groups.|Kruskal-Wallis|||Null hypothesis: no difference of time to extubation between group. Statistical power 80% and level of significance 0.05|
1646327|NCT01780584|3027893|Superiority or Other||Mean Difference (Final Values)|2.0|Standard Error of the Mean|0.8|<|0.05|2-Sided|95.0|1.0|3.0||Repeated Anova was used to determine whether there was difference of FT3 levels between groups|ANOVA|||Null hypothesis: no difference of free T3 (FT3) levels will be found between placebo, low dose and high dose group. We anticipated a difference of 2 pg/ml in FT3 with a standard deviation of 0.8 pg/ml between groups. For a statistical power of 80% to identify a treatment effect and at a level significance of 0.05 (2-sided).|
1646372|NCT01778751|3028012|Superiority or Other||Mean Difference (Net)|1.1||||0.397|2-Sided|95.0|-1.4|3.6|||Mixed Models Analysis|||Comparison at 6 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.|
1646328|NCT01780506|3027923|Non-Inferiority or Equivalence|Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was < 12% worse than the E/C/F/TDF group.|Difference in percentages|0.5||||0.78|2-Sided|95.002|-3.0|4.0||P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or > 100,000 copies/mL) and region (US vs ex-US).|Cochran-Mantel-Haenszel||The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.||
1646329|NCT01779869|3027938|Superiority|Accuracy was assessed compared to an imaging reference standard.||||||0.35|||||||Chi-squared|||Significance testing between the diagnostic accuracy of SPECT and PET, and SPECT and MR, and SPECT and PET/MR was performed by using chi square test. A P value < 0.05 was considered significant.|
1646330|NCT01779648|3027957|Superiority or Other|||||||0.132|||||||Mixed Models Analysis|Age, sex, body mass index, and baseline total volume flow are controlled as fixed-effects parameters.|||
1646331|NCT01779648|3027958|Superiority or Other|||||||0.008|||||||Mixed Models Analysis|Age, sex, body mass index, and baseline peak volume flow are controlled as fixed-effects parameters.|||
1646332|NCT01779648|3027960|Superiority or Other|||||||0.929|||||||Mixed Models Analysis|Age, sex, body mass index, and baseline PV (peak velocity)are controlled as fixed-effects parameters.|||
1646333|NCT01779648|3027961|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Age, sex, body mass index, and baseline PVF (peak volume flow) are controlled as fixed-effects parameters.|||
1646334|NCT01779648|3027962|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Age, sex, body mass index, and baseline TVF (total volume flow) are controlled as fixed-effects parameters.|||
1646335|NCT01779648|3027963|Superiority or Other|||||||0.301|||||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.|
1646336|NCT01779648|3027964|Superiority or Other|||||||0.158|||||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.|
1646337|NCT01779648|3027965|Superiority or Other|||||||0.722|||||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.|
1646338|NCT01779648|3027966|Superiority or Other|||||||0.195|||||||t-test, 2 sided|||Mean of right and left leg values were compared between the two device groups.|
1646339|NCT01779648|3027967|Superiority or Other|||||||0.785|||||||Chi-squared||||
1646340|NCT01779440|3027969|Superiority|||||||0.65||||||The P-Value of 0.65 was calculated from the difference between groups for the above outcome variable.|Chi-squared||||
1646341|NCT01779375|3027972|Superiority||||||>|0.05|||||||Regression, Linear|||Analyses were completed on a log scale and re-exponentiated for display.|
1646342|NCT01779375|3027974|Superiority||||||>|0.05|||||||Regression, Linear|||Analyses were completed on a log scale and re-exponentiated for presentation.|
1646343|NCT01779375|3027975|Superiority||||||>|0.05||||||All analyses were conducted with values on a log scale and re-exponentiated for presentation.|Regression, Linear|Measures of ß-cell response were modeled simultaneously with insulin sensitivity (M/I) using 2-df seemingly unrelated regression models.||Seemingly unrelated regression was used to compare treatment arms on the combination of insulin sensitivity (M/I as calculated from the hyperglycemic clamp) and insulin secretion (steady-state C-peptide and ACPRmax as co-primary; ACPRg as major secondary,). See statistical analysis plan for further details and R code.|
1646344|NCT01779219|3027976|Superiority or Other|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||"Time of the operation (skin-to-skin)"|
1646345|NCT01779219|3027976|Superiority or Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Time of preoperative preparations|
1646346|NCT01779219|3027976|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Total OR time|
1646347|NCT01779219|3027977|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|||Length of the postoperative hospital stay|
1646348|NCT01779219|3027977|Superiority or Other|||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Length of the preoperative hospital stay|
1646349|NCT01779219|3027977|Superiority or Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Total length of hospital stay|
1646350|NCT01779219|3027978|Superiority or Other|||||||1|||||||Fisher Exact||||
1646351|NCT01779219|3027979|Superiority or Other|||||||1||||||Fisher's exact test (two-tailed)|Fisher Exact||||
1646352|NCT01778985|3027991|Superiority or Other|||||||1|||||||t-test, 2 sided||||
1646353|NCT01778985|3027992|Superiority or Other|||||||0.06|||||||t-test, 2 sided||||
1646354|NCT01778985|3027993|Superiority or Other|||||||0.25|||||||t-test, 2 sided||||
1646355|NCT01778985|3027994|Superiority or Other|||||||0.7|||||||t-test, 2 sided||||
1646356|NCT01778985|3027995|Superiority or Other|||||||0.82|||||||t-test, 2 sided||||
1646357|NCT01778985|3027996|Superiority or Other|||||||0.15|||||||t-test, 2 sided||||
1646358|NCT01778985|3027997|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1646359|NCT01778985|3027998|Superiority or Other|||||||0.33|||||||t-test, 2 sided||||
1646360|NCT01778985|3027999|Superiority or Other|||||||0.53|||||||t-test, 2 sided||||
1646361|NCT01778985|3028000|Superiority or Other|||||||0.24||||||t(23)=1.23, p=0.24|t-test, 2 sided||||
1646362|NCT01778985|3028001|Superiority or Other|||||||0.51||||||t(28)=0.67, p=0.51|t-test, 2 sided||||
1646363|NCT01778985|3028002|Superiority or Other|||||||0.78||||||t(23)=0.28, p=0.78|t-test, 2 sided||||
1646364|NCT01778985|3028003|Superiority or Other|||||||0.02||||||t(10)=2.76, p=0.020|t-test, 2 sided||||
1646365|NCT01778985|3028004|Superiority or Other|||||||0.1||||||t(18)=1.69, p=.10|t-test, 2 sided||||
1646366|NCT01778985|3028005|Superiority or Other|||||||0.91||||||t(28)=0.11, p=0.91|t-test, 2 sided||||
1646367|NCT01778985|3028006|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1646368|NCT01778985|3028007|Superiority or Other|||||||0.088|||||||t-test, 2 sided|t(18)=1.78, p=0.088|||
1646369|NCT01778985|3028008|Superiority or Other|||||||0.22|||||||t-test, 2 sided||||
1646370|NCT01778985|3028009|Superiority or Other|||||||0.002|||||||t-test, 2 sided||||
1646371|NCT01778985|3028010|Superiority or Other|||||||0.21|||||||t-test, 2 sided||||
1646373|NCT01778751|3028012|Superiority or Other||Mean Difference (Net)|-0.9||||0.428|2-Sided|95.0|-3.3|1.4|||Mixed Models Analysis|||Comparison at 3 months. Scale is 0-27 where a lower score is a better outcome, values were dichotomized to indicate whether or not the patient was depressed.|
1646374|NCT01778751|3028013|Superiority or Other||Odds Ratio (OR)|1.02||||0.97|2-Sided|95.0|0.33|3.19|||Generalized Estimating Equation (GEE)|||Comparison at 6 months|
1646375|NCT01778751|3028013|Superiority or Other||Odds Ratio (OR)|0.9||||0.83|2-Sided|95.0|0.35|2.34|||Generalized estimating equation (GEE)||||
1646376|NCT01778751|3028014|Superiority or Other||Mean Difference (Net)|7.7||||0.027|2-Sided|95.0|0.9|14.4|||Mixed Models Analysis|||Comparison at 6 months, Scale is 0-100 where a higher score is a better outcome.|
1646377|NCT01778751|3028014|Superiority or Other||Mean Difference (Net)|2.9||||0.303|2-Sided|95.0|-2.7|8.4|||Mixed Models Analysis|||Comparison at 3 months, Scale is 0-100 where a higher score is a better outcome.|
1646378|NCT01778751|3028015|Superiority or Other||Mean Difference (Net)|-1.0||||0.05|2-Sided|95.0|-2.0|0.0|||Mixed Models Analysis|||Comparison at 6 months|
1646379|NCT01778751|3028015|Superiority or Other||Mean Difference (Net)|-1.0||||0.012|2-Sided|95.0|-1.7|-0.2|||Mixed Models Analysis|||Comparison at 3 months|
1646380|NCT01778634|3028016|Superiority|||||||1|||||||Fisher Exact||||
1646381|NCT01778634|3028017|Superiority|||||||0.33|||||||Generalized Estimating Equations||||
1646382|NCT01778634|3028018|Superiority|||||||1|||||||Fisher Exact||||
1646383|NCT01778634|3028019|Superiority|||||||0.091|||||||Fisher Exact||||
1646384|NCT01778634|3028020|Superiority|||||||0.18|||||||Generalized Estimating Equations||||
1646385|NCT01778634|3028021|Superiority|||||||1|||||||Fisher Exact||||
1646386|NCT01778634|3028022|Superiority|||||||0.05|||||||Generalized Estimating Equation||||
1646387|NCT01778634|3028024|Superiority|||||||0.18|||||||Generalized Estimating Equations||||
1646388|NCT01778634|3028025|Superiority||Odds Ratio (OR)|1.07||||0.88|2-Sided|95.0|0.44|2.63|||Cochran-Mantel-Haenszel||||
1646389|NCT01778634|3028026|Superiority|||||||0.49|||||||Fisher Exact||||
1646390|NCT01778634|3028027|Superiority||Median Difference (Final Values)|5.0||||0.94|2-Sided|95.0|-15.0|26.0||To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.|Wilcoxon test after multiple outputation||Bootstrap||
1646391|NCT01778634|3028028|Superiority|||||||0.88||||||To include non-survivors as bad values of this outcome we imputed a high value for the participants who died. Note, because we analyzed the data using a nonparametric test, the actual value doesn't affect the analysis, only the rank of the value.|Wilcoxon (Mann-Whitney)||||
1646392|NCT01778634|3028029|Superiority|||||||1|||||||Fisher Exact||||
1646393|NCT01778634|3028032|Superiority||Risk Difference (RD)|0.11||||0.28|2-Sided|95.0|-0.08|0.29|||Generalized Estimating Equations||Generalized Estimating Equations with an identity link||
1646394|NCT01778634|3028033|Superiority||Odds Ratio (OR)|7.51|||<|0.0001|2-Sided|95.0|2.53|22.27|||Cochran-Mantel-Haenszel||||
1646395|NCT01778127|3028048|Superiority or Other|||||||0.81|||||||t-test, 2 sided||||
1646396|NCT01778127|3028048|Superiority or Other|||||||0.11|||||||t-test, 2 sided||||
1646397|NCT01778127|3028048|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1646398|NCT01778127|3028049|Superiority or Other|||||||0.83|||||||t-test, 2 sided||||
1646399|NCT01778127|3028049|Superiority or Other|||||||0.15|||||||t-test, 2 sided||||
1646400|NCT01778127|3028049|Superiority or Other|||||||0.08|||||||t-test, 2 sided||||
1646401|NCT01778127|3028050|Superiority or Other|||||||0.81|||||||t-test, 2 sided||||
1646402|NCT01778127|3028050|Superiority or Other|||||||0.13|||||||t-test, 2 sided||||
1646403|NCT01778127|3028050|Superiority or Other|||||||0.17|||||||t-test, 2 sided||||
1646404|NCT01778127|3028051|Superiority or Other|||||||0.54|||||||t-test, 2 sided||||
1646405|NCT01778127|3028051|Superiority or Other|||||||0.19|||||||t-test, 2 sided||||
1646406|NCT01778127|3028051|Superiority or Other|||||||0.44|||||||t-test, 2 sided||||
1646407|NCT01778127|3028052|Superiority or Other|||||||0.99|||||||t-test, 2 sided||||
1646408|NCT01778127|3028052|Superiority or Other|||||||0.83|||||||t-test, 2 sided||||
1646409|NCT01778127|3028052|Superiority or Other|||||||0.83|||||||t-test, 2 sided||||
1646410|NCT01778127|3028053|Superiority or Other|||||||0.83|||||||t-test, 2 sided||||
1646411|NCT01778127|3028053|Superiority or Other|||||||0.95|||||||t-test, 2 sided||||
1646412|NCT01778127|3028053|Superiority or Other|||||||0.78|||||||t-test, 2 sided||||
1646413|NCT01778127|3028054|Superiority or Other|||||||0.59|||||||t-test, 2 sided||||
1646414|NCT01778127|3028054|Superiority or Other|||||||0.89|||||||t-test, 2 sided||||
1646415|NCT01778127|3028054|Superiority or Other|||||||0.69|||||||t-test, 2 sided||||
1646416|NCT01778127|3028055|Superiority or Other|||||||0.99|||||||t-test, 2 sided||||
1646417|NCT01778127|3028055|Superiority or Other|||||||0.64|||||||t-test, 2 sided||||
1646418|NCT01778127|3028055|Superiority or Other|||||||0.61|||||||t-test, 2 sided||||
1646419|NCT01778127|3028056|Superiority or Other|||||||0.89|||||||t-test, 2 sided||||
1646420|NCT01778127|3028056|Superiority or Other|||||||0.43|||||||t-test, 2 sided||||
1646421|NCT01778127|3028056|Superiority or Other|||||||0.49|||||||t-test, 2 sided||||
1646422|NCT01778127|3028057|Superiority or Other|||||||0.09|||||||t-test, 2 sided||||
1646423|NCT01778127|3028057|Superiority or Other|||||||0.63|||||||t-test, 2 sided||||
1646424|NCT01778127|3028057|Superiority or Other|||||||0.03|||||||t-test, 2 sided||||
1646425|NCT01778127|3028058|Superiority or Other|||||||0.37|||||||t-test, 2 sided||||
1646426|NCT01778127|3028058|Superiority or Other|||||||0.84|||||||t-test, 2 sided||||
1646427|NCT01778127|3028058|Superiority or Other|||||||0.49|||||||t-test, 2 sided||||
1646428|NCT01778127|3028059|Superiority or Other|||||||0.14|||||||t-test, 2 sided||||
1646432|NCT01778049|3028064|Superiority or Other||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|0.22||0.0452||95.0|-0.87|-0.01|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).|Superiority of lina5 (E25) vs. Plc (E25): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c & baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.|
1646433|NCT01778049|3028064|Superiority or Other||Mean Difference (Final Values)|-0.65|Standard Error of the Mean|0.25||0.0103||95.0|-1.15|-0.16|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E10) minus Plc (E10).|Superiority of lina5 (E10) vs. Plc (E10): change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c & baseline eGFR as linear covariates, geographical region, treatment, visit, visit by treatment interaction as fixed effects.|
1646434|NCT01778049|3028065|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.66|-0.28|||MMRM|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference value calculated as lina5 (E25) minus Plc (E25).|Superiority of lina5 (E25) vs. Plc (E25): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates & baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effects.|
1646435|NCT01778049|3028065|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.1|<|0.0013||95.0|-0.52|-0.13|||Mixed Model Repeated Measure (MMRM)|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the adjusted mean difference calculated as lina5 (E10) minus Plc (E10) value.|Superiority of lina5 (E10) vs. Plc (E10): change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. The model includes baseline HbA1c as linear covariates & baseline estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effects.|
1646436|NCT01778023|3028072|Superiority or Other||Treatment Difference|5.15|||<|0.0001|2-Sided|95.0|4.09|6.21|||ANOVA|The HV after 6 months of treatment was analysed using an ANCOVA method with group and sex as fixed effects, and age as a covariate.||Let D be a mean difference of the primary endpoint between group A and group B. Null hypothesis H0: D = 0 vs. alternative H1: D ≠ 0 will be statistically tested by an ANOVA model.|
1646437|NCT01777997|3028084|Other|||||||0.001|||||||Regression, repeated measures (GEE)|||Estimated mean change from baseline to weeks 24-48 on ART from repeated measures (GEE) model, against the null hypothesis of zero change. Estimated mean represents on ART levels minus pre-ART levels.|
1646438|NCT01777568|3028145|Superiority||Risk Ratio (RR)|0.8||||0.047|2-Sided|95.0|0.66|1.01|||Chi-squared||||
1646439|NCT01777568|3028146|Superiority||Risk Ratio (RR)|0.99||||0.85|2-Sided|95.0|0.85|1.14|||GEE model||Relative Risk: 80% (numerator) vs. 30% (denominator)||
1646440|NCT01777334|3028179|Superiority or Other||Least squares mean difference|0.112|||<|0.001|2-Sided|95.0|0.081|0.144|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus TIO 18 µg.||
1646441|NCT01777269|3028320|Superiority or Other||Adjusted mean difference|-7.79|||<|0.001|2-Sided|95.0|-10.22|-5.35|||mixed-model repeated-measures||Par. with IPSS change from baseline >=25 points improvement at any time post-baseline visit||
1646442|NCT01777269|3028321|Superiority or Other||Adjusted mean difference|-7.39|||<|0.001|2-Sided|95.0|-9.79|-4.99|||mixed-model repeated-measures||Par. with IPSS change from baseline >=3 points improvement at any time post-baseline visit||
1646443|NCT01777269|3028321|Superiority or Other||Adjusted mean difference|-7.78|||<|0.001|2-Sided|95.0|-10.07|-5.49|||mixed-model repeated-measures||Par. with IPSS change from baseline >=2 points improvement at any time post-baseline visit||
1646444|NCT01777269|3028322|Superiority or Other||Adjusted mean difference|-3.51|||<|0.001|2-Sided|95.0|-4.87|-2.14|||mixed-model repeated-measures||Month 12||
1646445|NCT01777269|3028322|Superiority or Other||Adjusted mean difference|-1.3|||<|0.042|2-Sided|95.0|-2.56|-0.05|||mixed-model repeated-measures||Month 9||
1646446|NCT01777269|3028322|Superiority or Other||Adjusted mean difference|-2.53|||<|0.001|2-Sided|95.0|-3.76|-1.3|||mixed-model repeated-measures||Month 6||
1646447|NCT01777269|3028322|Superiority or Other||Adjusted mean difference|-2.11|||<|0.001|2-Sided|95.0|-3.25|-0.98|||mixed-model repeated-measures||Month 3||
1646448|NCT01777269|3028322|Superiority or Other||Adjusted mean difference|-2.1|||<|0.001|2-Sided|95.0|-3.15|-1.06|||mixed-model repeated-measures||Month 1||
1646449|NCT01777269|3028322|Superiority or Other||Adjusted mean difference|-3.0|||<|0.001|2-Sided|95.0|-3.89|-2.1|||mixed-model repeated-measures||Week 2||
1646450|NCT01777269|3028323|Superiority or Other||Adjusted mean difference|-0.58||||0.023|2-Sided|95.0|-1.08|-0.08|||mixed-model repeated-measures||Month 12||
1646451|NCT01777269|3028323|Superiority or Other||Adjusted mean difference|-0.45||||0.056|2-Sided|95.0|-0.91|0.01|||mixed-model repeated-measures||Month 9||
1646452|NCT01777269|3028323|Superiority or Other||Adjusted mean difference|-0.62||||0.009|2-Sided|95.0|-1.09|-0.15|||mixed-model repeated-measures||Month 6||
1646453|NCT01777269|3028323|Superiority or Other||Adjusted mean difference|-0.26||||0.21|2-Sided|95.0|-0.67|0.15|||mixed-model repeated-measures||Month 3||
1646454|NCT01777269|3028323|Superiority or Other||Adjusted mean difference|0.0||||1|2-Sided|95.0|-0.37|0.37|||mixed-model repeated-measures||Month 1||
1646455|NCT01777269|3028323|Superiority or Other||Adjusted mean difference|-0.4||||0.036|2-Sided|95.0|-0.78|-0.03|||mixed-model repeated-measures||Week 2||
1646456|NCT01777269|3028324|Superiority or Other||Adjusted mean difference|-1.97|||<|0.001|2-Sided|95.0|-3.12|-0.83|||mixed-model repeated-measures||Month 12||
1646457|NCT01777269|3028324|Superiority or Other||Adjusted mean difference|-1.34|||<|0.013|2-Sided|95.0|-2.4|-0.28|||mixed-model repeated-measures||Month 9||
1646458|NCT01777269|3028324|Superiority or Other||Adjusted mean difference|-1.73|||<|0.001|2-Sided|95.0|-2.74|-0.72|||mixed-model repeated-measures||Month 6||
1646462|NCT01777269|3028325|Superiority or Other||Adjusted mean difference|-0.83||||0.047|2-Sided|95.0|-1.65|-0.01|||mixed-model repeated-measures||Month 12||
1646463|NCT01777269|3028325|Superiority or Other||Adjusted mean difference|-1.15||||0.009|2-Sided|95.0|-2.01|-0.3|||mixed-model repeated-measures||Month 9||
1646464|NCT01777269|3028325|Superiority or Other||Adjusted mean difference|-1.73|||<|0.001|2-Sided|95.0|-2.57|-0.88|||mixed-model repeated-measures||Month 6||
1646465|NCT01777269|3028325|Superiority or Other||Adjusted mean difference|-0.93|||<|0.017|2-Sided|95.0|-1.69|-0.17|||mixed-model repeated-measures||Month 3||
1646466|NCT01777269|3028325|Superiority or Other||Adjusted mean difference|-0.94|||<|0.012|2-Sided|95.0|-1.67|-0.21|||mixed-model repeated-measures||Month 1||
1646467|NCT01777269|3028326|Superiority or Other||Adjusted mean difference|-6.92|||<|0.001|2-Sided|95.0|-8.47|-5.38|||mixed-model repeated-measures||Month 12||
1646468|NCT01777269|3028326|Superiority or Other||Adjusted mean difference|-7.05|||<|0.001|2-Sided|95.0|-8.51|-5.59|||mixed-model repeated-measures||Month 9||
1646469|NCT01777269|3028326|Superiority or Other||Adjusted mean difference|-6.82|||<|0.001|2-Sided|95.0|-8.3|-5.34|||mixed-model repeated-measures||Month 6||
1646470|NCT01777269|3028326|Superiority or Other||Adjusted mean difference|-5.24|||<|0.001|2-Sided|95.0|-6.59|-3.9|||mixed-model repeated-measures||Month 3||
1646471|NCT01777269|3028326|Superiority or Other||Adjusted mean difference|-2.89|||<|0.001|2-Sided|95.0|-4.07|-1.7|||mixed-model repeated-measures||Month 1||
1646472|NCT01777269|3028327|Superiority or Other||Adjusted mean difference|-0.46||||0.091|2-Sided|95.0|-0.99|0.07|||mixed-model repeated-measures||Month 12||
1646473|NCT01777269|3028327|Superiority or Other||Adjusted mean difference|-0.68||||0.009|2-Sided|95.0|-1.19|-0.17|||mixed-model repeated-measures||Month 9||
1646474|NCT01777269|3028327|Superiority or Other||Adjusted mean difference|-0.37||||0.16|2-Sided|95.0|-0.88|0.15|||mixed-model repeated-measures||Month 6||
1646475|NCT01777269|3028327|Superiority or Other||Adjusted mean difference|-0.24||||0.33|2-Sided|95.0|-0.71|0.24|||mixed-model repeated-measures||Month 3||
1646476|NCT01777269|3028327|Superiority or Other||Adjusted mean difference|-0.2||||0.37|2-Sided|95.0|-0.62|0.23|||mixed-model repeated-measures||Month 1||
1646477|NCT01777269|3028329|Superiority or Other||Adjusted mean difference|-8.82|||<|0.001|2-Sided|95.0|-10.96|-6.67|||mixed-model repeated-measures||Month 9||
1646478|NCT01777269|3028329|Superiority or Other||Adjusted mean difference|-9.04|||<|0.001|2-Sided|95.0|-11.31|-6.77|||mixed-model repeated-measures||Month 6||
1646479|NCT01777269|3028329|Superiority or Other||Adjusted mean difference|-6.43|||<|0.001|2-Sided|95.0|-8.45|-4.41|||Adjusted mean difference||Month 3||
1646480|NCT01777269|3028329|Superiority or Other||Adjusted mean difference|-4.11|||<|0.001|2-Sided|95.0|-6.01|-2.21|||mixed-model repeated-measures||Month 1||
1646481|NCT01777269|3028330|Superiority or Other||Adjusted mean difference|-8.0|||<|0.001|2-Sided|95.0|-10.22|-5.79|||mixed-model repeated-measures||||
1646482|NCT01777191|3028334|Superiority or Other (legacy)|||||||0.248|||||||Fisher Exact||||
1646483|NCT01777126|3028386|Superiority or Other|||||||0.698|||||||Chi-squared|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were < 0.05.|
1646484|NCT01777126|3028387|Superiority or Other|||||||0.049|||||||Chi-squared|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square Test. Outcome measures were considered statistically significant if p-values were < 0.05.|
1646485|NCT01777126|3028388|Superiority or Other|||||||0.117|||||||Fisher Exact|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Fisher’s Exact Test. The result was considered statistically significant if p-values were < 0.05.|
1646486|NCT01777126|3028389|Superiority or Other||Median Difference (Final Values)|0.0||||0.302|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1646487|NCT01777126|3028390|Superiority or Other|||||||0.487|||||||Fisher Exact|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using Chi-square and Fisher’s Exact Test. Results were considered statistically significant if p-values were < 0.05.|
1646488|NCT01777126|3028391|Superiority or Other||Median Difference (Final Values)|4.0|||<|0.01|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)|||Statistical analysis was performed by the Leuven Statistics Research Centre, KU Leuven, using SPSS package (SPSS Statistics 20.0 for Windows). Statistical analysis was performed using the Wilcoxon rank sum test. The result was considered statistically significant if p-values were < 0.05.|
1646489|NCT01777126|3028394|Superiority or Other||Median Difference (Final Values)|3.0|||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home. Preliminary data from our institution showed that all patients received parenteral nutrition very early post-surgery and were discharged after a mean of 19.3 ± 5.6 days. Therefore, the primary objective by implementing the ONP was to reduce the length of stay with 3 days.|
1646490|NCT01776632|3028412|Superiority||difference of adjusted means|-1.27||||0.09|2-Sided||||||mixed effects models||||
1646491|NCT01776632|3028413|Superiority||difference of adjusted means|-0.43||||0.04|2-Sided||||||mixed effects models||||
1646492|NCT01776632|3028414|Superiority||difference of adjusted means|0.39||||0.003|2-Sided||||||generalized linear mixed effects||||
1646493|NCT01776632|3028415|Superiority||difference of adjusted means|0.15||||0.03|2-Sided||||||generalized linear mixed effects||||
1646494|NCT01776424|3028441|Superiority||Hazard Ratio (HR)|0.97||||0.66418|2-Sided|95.0|0.84|1.12||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model||
1646495|NCT01776424|3028441|Superiority||Hazard Ratio (HR)|0.82||||0.01062|2-Sided|95.0|0.71|0.96||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model||
1646496|NCT01776424|3028442|Superiority||Hazard Ratio (HR)|0.88||||0.03995||95.0|0.77|0.99||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model||
1646497|NCT01776424|3028442|Superiority||Hazard Ratio (HR)|0.74||||1e-05|2-Sided|95.0|0.65|0.85||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model||
1646498|NCT01776424|3028443|Superiority||Hazard Ratio (HR)|0.88||||0.06437|2-Sided|95.0|0.77|1.01||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model||
1646499|NCT01776424|3028443|Superiority||Hazard Ratio (HR)|0.72||||1e-05|2-Sided|95.0|0.63|0.83||Nominal p-value|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model||
1646500|NCT01776424|3028444|Superiority||Hazard Ratio (HR)|1.51||||3e-05|2-Sided|95.0|1.25|1.84|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model||
1646501|NCT01776424|3028444|Superiority||Hazard Ratio (HR)|1.7|||<|1e-05|2-Sided|95.0|1.4|2.05|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model||
1646502|NCT01776424|3028445|Superiority||Hazard Ratio (HR)|0.9||||0.1149|2-Sided|95.0|0.79|1.03|||Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model||
1646503|NCT01776424|3028445|Superiority||Hazard Ratio (HR)|0.76||||4e-05|2-Sided|95.0|0.66|0.86||Independent DSMB recommended to stop rivaroxaban/aspirin arms on 06FEB2017. At first interim analysis(~50% events) the log-rank test statistic for one primary comparison had crossed the modified Haybittle-Peto boundary(z=4) consistently over 3 months|Log Rank|Log-rank test (stratified by pantoprazole randomization)|Stratified Cox proportional hazards model||
1646504|NCT01775189|3028590|Superiority or Other||LS Mean Difference|136.2|||<|0.0001|2-Sided|95.0|119.8|152.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646505|NCT01775189|3028590|Superiority or Other||LS Mean Difference|130.8|||<|0.0001|2-Sided|95.0|114.5|147.0||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646506|NCT01775189|3028590|Superiority or Other||LS Mean Difference|-5.4|||<|0.5117|2-Sided|95.0|-21.8|10.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646507|NCT01775189|3028590|Superiority or Other||LS Mean Difference|21.4|||<|0.0109|2-Sided|95.0|5.1|37.8||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646508|NCT01775189|3028590|Superiority or Other||LS Mean Difference|-109.3|||<|0.0001|2-Sided|95.0|-125.7|-93.0||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646509|NCT01775189|3028590|Superiority or Other||LS Mean Difference|26.9|||<|0.0015|2-Sided|95.0|10.6|43.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646510|NCT01775189|3028591|Superiority or Other||LS Mean Difference|86.3|||<|0.0001|2-Sided|95.0|75.4|97.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646511|NCT01775189|3028591|Superiority or Other||LS Mean Difference|79.9|||<|0.0001|2-Sided|95.0|69.2|90.7||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646512|NCT01775189|3028591|Superiority or Other||LS Mean Difference|-6.3|||<|0.2507|2-Sided|95.0|-17.2|4.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646513|NCT01775189|3028591|Superiority or Other||LS Mean Difference|18.2|||<|0.0012|2-Sided|95.0|7.4|29.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646514|NCT01775189|3028591|Superiority or Other||LS Mean Difference|-61.7|||<|0.0001|2-Sided|95.0|-72.6|-50.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646515|NCT01775189|3028591|Superiority or Other||LS Mean Difference|24.5|||<|0.0001|2-Sided|95.0|13.8|35.3||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646516|NCT01775189|3028592|Superiority or Other||LS Mean Difference|61.2|||<|0.0001|2-Sided|95.0|50.6|71.7||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646517|NCT01775189|3028592|Superiority or Other||LS Mean Difference|59.6|||<|0.0001|2-Sided|95.0|49.0|70.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646518|NCT01775189|3028592|Superiority or Other||LS Mean Difference|-1.6|||<|0.7624|2-Sided|95.0|-12.1|8.9||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646552|NCT01774344|3028708|Superiority or Other||Difference|-31.39|||<|1e-06|2-Sided|95.0|-39.57|-23.22|||Cochran-Mantel-Haenszel|||Regorafenib v Placebo-RECIST 1.1: Comparison of treatments were calculated.|
1646519|NCT01775189|3028592|Superiority or Other||LS Mean Difference|5.0|||<|0.3502|2-Sided|95.0|-5.6|15.5||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646520|NCT01775189|3028592|Superiority or Other||LS Mean Difference|-54.6|||<|0.0001|2-Sided|95.0|-65.1|-44.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646521|NCT01775189|3028592|Superiority or Other||LS Mean Difference|6.6|||<|0.2176|2-Sided|95.0|-4.0|17.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646522|NCT01775189|3028593|Superiority or Other||LS Mean Difference|41.8|||<|0.0001|2-Sided|95.0|37.1|46.4||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646523|NCT01775189|3028593|Superiority or Other||LS Mean Difference|41.4|||<|0.0001|2-Sided|95.0|36.8|46.1||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646524|NCT01775189|3028593|Superiority or Other||LS Mean Difference|-0.4|||<|0.8806|2-Sided|95.0|-5.0|4.3||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646525|NCT01775189|3028593|Superiority or Other||LS Mean Difference|9.1|||<|0.0002|2-Sided|95.0|4.5|13.8||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646526|NCT01775189|3028593|Superiority or Other||LS Mean Difference|-32.3|||<|0.0001|2-Sided|95.0|-37.0|-27.6||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646527|NCT01775189|3028593|Superiority or Other||Least Squares (LS) mean Difference|9.5|||<|0.0001|2-Sided|95.0|4.8|14.2||P-value was adjusted using Benjamini-Hochberg method.|Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1646528|NCT01775124|3028625|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.6|||||2-Sided|95.0|-2.95|-0.2||||||Descriptive, no hypothesis|
1646529|NCT01774981|3028629|Superiority or Other (legacy)|||||||0.2219|||||||t-test, 1 sided||||
1646530|NCT01774981|3028629|Superiority or Other (legacy)|||||||0.0808|||||||t-test, 1 sided||||
1646531|NCT01774981|3028629|Superiority or Other (legacy)|||||||0.0449|||||||t-test, 1 sided||||
1646532|NCT01774968|3028644|Non-Inferiority or Equivalence|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.1||||0.3709|2-Sided|95.0|-0.33|0.12|||Mixed Models Analysis|||Approximately 325 participants were to be randomized (in a 1:1 ratio of U-500R insulin TID:BID) and 260 were to complete the study (with a 20% dropout rate). The 260 completers would provide a 66.4% chance to show equivalence of TID and BID algorithms, 14.4% chance to show noninferiority of TID, 2.5% chance to superiority of TID, 14.4% chance to show noninferiority of BID, and 2.5% chance to show superiority of BID, assuming a difference in HbA1c change of 0% and a standard deviation of 1.1%.|
1646533|NCT01774799|3028653|Superiority|||||||0.32|||||||Regression, Linear||||
1646534|NCT01774799|3028654|Superiority||Odds Ratio (OR)|1.79|||||2-Sided|95.0|1.13|2.82|||||||
1646535|NCT01774799|3028655|Superiority||Odds Ratio (OR)|0.96|||||2-Sided|95.0|0.58|1.58|||||||
1646536|NCT01774799|3028656|Superiority||Hazard Ratio (HR)|1.2|||||2-Sided|95.0|0.66|2.2|||||||
1646537|NCT01774799|3028657|Superiority||Odds Ratio (OR)|1.08|||||2-Sided|95.0|0.69|1.69|||||||
1646538|NCT01774786|3028669|Superiority||Hazard Ratio (HR)|0.73|||||2-Sided|95.0|0.62|0.86|||||A stratified Cox proportional hazards regression model was used to estimate the HR between treatment arms with a 95% Confidence Interval.||
1646539|NCT01774786|3028670|Superiority|The study was designed to have 80% power to show a significant difference with respect to the primary endpoint.|Hazard Ratio (HR)|0.84||||0.0565|2-Sided|95.0|0.71|1.0||The actual p-value significance threshold required for OS was 0.0452, after alpha spent at the interim analysis was taken into account.|Stratified Log-Rank|Patients were stratified according to geographic region, prior gastrectomy, and HER2 status.||The null hypothesis is that the survival distribution of OS is the same in the two treatment arms.|
1646540|NCT01774721|3028681|Superiority||Cox Proportional Hazard|1.173||||0.5327|2-Sided|95.0|0.928|1.483|||2-sided Hochberg adjusted p-value||||
1646541|NCT01774721|3028688|Superiority||Hazard Ratio (HR)|0.545|||<|0.0001|2-Sided|95.0|0.418|0.711|||1-sided stratified log-rank test||Based on stratified Cox regression model|Comparison of dacomitinib vs gefitinib based on Investigator assessment|
1646542|NCT01774721|3028688|Superiority||Hazard Ratio (HR)|0.403|||<|0.0001|2-Sided|95.0|0.307|0.529|||1-sided stratified log-rank test||Based on stratified Cox regression model|Comparison of dacomitinib vs gefitinib based on IRC review|
1646543|NCT01774721|3028693|Superiority||Hazard Ratio (HR)|0.622|||<|0.0001|2-Sided|95.0|0.497|0.779|||1-sided stratified log-rank test||Based on stratified Cox regression model||
1646544|NCT01774721|3028694|Superiority||Hazard Ratio (HR)|0.589|||<|0.0001|2-Sided|95.0|0.469|0.739|||1-sided stratified log-rank test||Based on stratified Cox regression model||
1646545|NCT01774604|3028695|Superiority or Other|||||||0.1|||||||Fisher Exact||||
1646546|NCT01774604|3028696|Superiority or Other|||||||0.25|||||||Fisher Exact||||
1646547|NCT01774604|3028697|Superiority or Other|||||||0.75|||||||Fisher Exact||||
1646548|NCT01774604|3028698|Superiority or Other|||||||0.15|||||||Fisher Exact||||
1646549|NCT01774604|3028699|Superiority or Other|||||||1|||||||Fisher Exact||||
1646550|NCT01774604|3028700|Superiority or Other|||||||1|||||||Fisher Exact||||
1646551|NCT01774604|3028701|Superiority or Other|||||||0.33|||||||Fisher Exact||||
1646553|NCT01774344|3028708|Superiority or Other||Difference|-29.31|||<|1e-06|2-Sided|95.0|-37.52|-21.11|||Cochran-Mantel-Haenszel|||Regorafenib v Placebo-mRECIST: Comparison of treatments were calculated.|
1646554|NCT01774344|3028709|Superiority or Other||Difference|-4.15||||0.019991|2-Sided|95.0|-7.55|-0.75|||Cochran-Mantel-Haenszel|||Regorafenib v Placebo-RECIST 1.1: Comparison of treatments were calculated.|
1646555|NCT01774344|3028709|Superiority or Other||Difference|-6.61||||0.004728|2-Sided|95.0|-10.84|-2.39|||Cochran-Mantel-Haenszel|||Regorafenib v Placebo-mRECIST: Comparison of treatments were calculated.|
1646556|NCT01774344|3028710|Superiority or Other||Hazard Ratio (HR)|0.453|||<|1e-06|2-Sided|95.0|0.375|0.548|||Log Rank|||Regorafenib v Placebo-RECIST 1.1: Unstratified: Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.|
1646557|NCT01774344|3028710|Superiority or Other||Hazard Ratio (HR)|0.427|||<|1e-06|2-Sided|95.0|0.348|0.524|||Log Rank|||Regorafenib v Placebo-RECIST 1.1:Stratified (IVRS): Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.|
1646558|NCT01774344|3028710|Superiority or Other||Hazard Ratio (HR)|0.481|||<|1e-06|2-Sided|95.0|0.398|0.581|||Log Rank|||Regorafenib v Placebo-mRECIST: Unstratified: Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.|
1646559|NCT01774344|3028710|Superiority or Other||Hazard Ratio (HR)|0.455|||<|1e-06|2-Sided|95.0|0.371|0.558|||Log Rank|||Regorafenib v Placebo-mRECIST: Stratified (IVRS): Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.|
1646560|NCT01774344|3028711|Superiority or Other||Hazard Ratio (HR)|0.443|||<|1e-06|2-Sided|95.0|0.365|0.539|||Log Rank|||Regorafenib v Placebo-RECIST 1.1: Unstratified: Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.|
1646561|NCT01774344|3028711|Superiority or Other||Hazard Ratio (HR)|0.414|||<|1e-06|2-Sided|95.0|0.335|0.511|||Log Rank|||Regorafenib v Placebo-RECIST 1.1:Stratified (IVRS): Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.|
1646562|NCT01774344|3028711|Superiority or Other||Hazard Ratio (HR)|0.472|||<|1e-06|2-Sided|95.0|0.389|0.573|||Log Rank|||Regorafenib v Placebo-mRECIST: Unstratified: Hazard ratio and its 95% CI was based on unstratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.|
1646563|NCT01774344|3028711|Superiority or Other||Hazard Ratio (HR)|0.442|||<|1e-06|2-Sided|95.0|0.358|0.545|||Log Rank|||Regorafenib v Placebo-mRECIST: Stratified (IVRS): Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Kaplan-Meier estimates.|
1646564|NCT01774344|3028712|Superiority or Other||Hazard Ratio (HR)|0.673||||0.000107|2-Sided|95.0|0.545|0.831||One-sided p-value was analyzed from log rank test.|Log Rank|||Regorafenib v Placebo: Unstratified (Sensitivity): Hazard ratio for OS and 95% confidence interval was calculated for unstratified (sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.|
1646565|NCT01774344|3028712|Superiority or Other||Hazard Ratio (HR)|0.661||||0.000155|2-Sided|95.0|0.527|0.829||One-sided p-value was analyzed from log rank test.|Log Rank|||Regorafenib v Placebo: Stratified (RAVE): Hazard ratio for OS and 95% confidence interval was calculated for stratified RAVE (Sensitivity) by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.|
1646566|NCT01774344|3028712|Superiority or Other||Hazard Ratio (HR)|0.627||||2e-05|2-Sided|95.0|0.5|0.785||One-sided p-value was analyzed from log rank test.|Log Rank|||Regorafenib v Placebo: Stratified (IVRS): Hazard ratio for OS and 95% confidence interval was calculated for stratified IVRS by using Cox model, stratified by the geographic region: Asia or Rest of the World (ROW), ECOG-PS: 0 versus 1, AFP level, presence versus absence of extrahepatic disease and presence versus absence of macrovascular invasion. Kaplan-Meier (KM) estimated for OS and KM survival curves were presented for each treatment arm.|
1646567|NCT01774097|3028727|Superiority or Other||Mean Difference (Net)|0.7|Standard Error of the Mean|2.0||0.722|2-Sided|95.0|-3.3|4.7||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear||||
1646568|NCT01774097|3028728|Superiority or Other||Mean Difference (Net)|-0.9|Standard Error of the Mean|1.6||0.591|2-Sided|95.0|-4.1|2.3||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear||||
1646569|NCT01774097|3028729|Superiority or Other||Mean Difference (Net)|0.9|Standard Error of the Mean|1.7||0.626|2-Sided|95.0|-2.6|4.2||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear||||
1646570|NCT01774097|3028730|Superiority or Other||Mean Difference (Net)|2.1|Standard Error of the Mean|1.4||0.131|2-Sided|95.0|-0.6|4.8||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear||||
1646571|NCT01774097|3028732|Superiority or Other||interaction term|0.2|Standard Error of the Mean|0.2||0.241|2-Sided|95.0|-0.2|0.6|||Regression, Linear||||
1646572|NCT01774097|3028733|Superiority or Other||interaction term|-0.02|Standard Error of the Mean|0.02||0.256|2-Sided|95.0|-0.06|0.02||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear||||
1646573|NCT01774097|3028734|Superiority or Other||interaction term|0.0|Standard Error of the Mean|0.01||0.871|2-Sided|95.0|-0.02|0.03||Threshold 0.05; no adjustment for multiple comparisons per protocol.|Regression, Linear||||
1646574|NCT01774097|3028735|Superiority or Other||Mean Difference (Net)|-0.17|Standard Error of the Mean|0.55||0.752|2-Sided|95.0|-1.26|0.91||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided||||
1646710|NCT01769469|3029097|Other|||||||0.4043|||||||Wilcoxon (Mann-Whitney)||||
1646575|NCT01774097|3028736|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.4||0.978|2-Sided|95.0|-0.8|0.8||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided||||
1646576|NCT01774097|3028737|Superiority or Other||Mean Difference (Net)|0.9|Standard Error of the Mean|0.6||0.116|2-Sided|95.0|-0.2|2.1||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided||||
1646577|NCT01774097|3028738|Superiority or Other||Mean Difference (Net)|0.9|Standard Error of the Mean|0.8||0.238|2-Sided|95.0|-0.6|2.5||Threshold 0.05; no adjustment for multiple comparisons per protocol.|t-test, 2 sided||||
1646578|NCT01773967|3028760|Superiority|||||||0.26|||||||Van Elteren's modification Mann-Whitney||||
1646579|NCT01773967|3028762|Superiority|||||||0.83|||||||Mantel Haenszel||||
1646580|NCT01773473|3028772|Non-Inferiority or Equivalence|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|0.17|||||2-Sided|95.0|-0.01|0.35|||||||
1646581|NCT01773421|3028778|Equivalence|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric LS Mean Ratio|1.13|||||2-Sided|90.0|1.0|1.27|||||||
1646582|NCT01773421|3028779|Equivalence|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric LS Mean Ratio|1.11|||||2-Sided|90.0|1.02|1.2|||||||
1646583|NCT01773421|3028780|Equivalence|Log-transformed pharmacokinetic parameters were fit using a mixed effects model with sequence, treatment, period and sequence as fixed effects and participant as a random effect. Geometric LS means and geometric LS mean ratio were back-transformed to obtain the treatment estimates.|Geometric Least Square (LS) Mean Ratio|1.06|||||2-Sided|90.0|0.97|1.15|||||||
1646584|NCT01773135|3028788|Superiority or Other||||||<|0.001|||||||U statistic||||
1646585|NCT01772823|3028797|Other|||||||0.0226||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared||||
1646586|NCT01772823|3028798|Other|||||||0.1847||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared||||
1646587|NCT01772823|3028799|Other|||||||0.0868||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared||||
1646588|NCT01772823|3028800|Other|||||||0.0617||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared||||
1646589|NCT01772823|3028801|Other|||||||0.2223||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared||||
1646590|NCT01772823|3028802|Other|||||||0.2881||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared||||
1646591|NCT01772823|3028803|Other|||||||0.688||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared||||
1646592|NCT01772823|3028804|Other|||||||0.1647||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared||||
1646593|NCT01772823|3028805|Other|||||||0.2482||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared||||
1646594|NCT01772823|3028806|Other|||||||0.0088||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared||||
1646595|NCT01772823|3028807|Other|||||||0.0706||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared||||
1646596|NCT01772823|3028808|Other|||||||0.1255||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared||||
1646597|NCT01772823|3028809|Other|||||||0.2193||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to this question) differ between intervention arms.|Chi-squared||||
1646598|NCT01772823|3028812|Other|||||||0.5369||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participation in high-risk sex acts) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact||||
1646599|NCT01772823|3028813|Other|||||||0.5279|||||||Kruskal-Wallis||||
1646600|NCT01772823|3028814|Other|||||||0.9037||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant BMI) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact||||
1646601|NCT01772823|3028815|Other|||||||0.8643||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified ethnicity) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact||||
1646602|NCT01772823|3028816|Other|||||||0.0298||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact||||
1646603|NCT01772823|3028817|Other|||||||0.2991||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant self-identified race) differ between groups (On PrEP vs. Off PrEP).|Fisher Exact||||
1646604|NCT01772823|3028819|Other|||||||0.107|||||||Kruskal-Wallis||||
1646711|NCT01769469|3029104|Other|||||||0.3483|||||||Wilcoxon Signed Rank Test||||
1646605|NCT01772823|3028820|Other|||||||0.029||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared||||
1646606|NCT01772823|3028821|Other|||||||0.0046||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared||||
1646607|NCT01772823|3028822|Other|||||||0.2747||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared||||
1646608|NCT01772823|3028823|Other|||||||0.1682||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared||||
1646609|NCT01772823|3028824|Other|||||||0.1201||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared||||
1646610|NCT01772823|3028825|Other|||||||0.43||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared||||
1646611|NCT01772823|3028826|Other|||||||0.1581||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared||||
1646612|NCT01772823|3028827|Other|||||||0.0766||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared||||
1646613|NCT01772823|3028828|Other|||||||0.0098||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared||||
1646614|NCT01772823|3028829|Other|||||||0.0001||||||The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant responses to the session evaluation question) differ between intervention arms.|Chi-squared||||
1646615|NCT01772823|3028833|Other|||||||0.5285||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Physician exam) differ between intervention arms."|Chi-squared||||
1646616|NCT01772823|3028834|Other|||||||0.0994||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Questions about sexual behavior) differ between intervention arms."|Chi-squared||||
1646617|NCT01772823|3028835|Other|||||||0.1226||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Risk Reduction counseling at every visit) differ between intervention arms."|Chi-squared||||
1646618|NCT01772823|3028836|Other|||||||0.1968||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on HIV test at every visit) differ between intervention arms."|Chi-squared||||
1646619|NCT01772823|3028837|Other|||||||0.3801||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Taking part in the study) differ between intervention arms."|Chi-squared||||
1646620|NCT01772823|3028838|Other|||||||0.4359||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on Taking the pill every day) differ between intervention arms."|Chi-squared||||
1646621|NCT01772823|3028839|Other|||||||0.3761||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Color of the Pill) differ between intervention arms."|Chi-squared||||
1646622|NCT01772823|3028840|Other|||||||0.8281||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Taste of the Pill) differ between intervention arms."|Chi-squared|Pearson Chi-Square|||
1646623|NCT01772823|3028841|Other|||||||0.7513||||||"The chi-squared test of homogeneity is used to assess whether the proportions of the independent variable (participant feelings on the Size of the Pill) differ between intervention arms."|Chi-squared||||
1646624|NCT01772550|3028877|Non-Inferiority or Equivalence|A 95% upper confidence bound for the observed difference in percentages of images with acceptable quality between the control catheter and evaluation catheter was calculated using the Score method. The 20 G BD Nexiva™ Diffusics™ can be considered non-inferior for acceptable image quality if this 95% upper confidence bound is smaller than 15% (i.e. C – D < 15% with 95% confidence). The non-inferiority margin was 15%.|Risk Difference (RD)|0.0|||||1-Sided|95.0||2.6|||||The difference in percent of acceptable image quality is used as an estimate. The Score method was used to estimate the upper 95% confidence limit.|Only the percent of acceptable image quality from the randomized test and reference catheter groups were considered for this statistical analysis. If C is the percentage of acceptable quality images with the control catheter, and D is the percentage of images of acceptable quality with the evaluation catheter, and the non-inferiority criteria is 15%, the hypotheses to be tested are as follows: H0: C – D > or = 15%; H1: C – D < 15%.|
1646625|NCT01772472|3028892|Superiority||Hazard Ratio (HR)|0.5|||<|0.0001||95.0|0.39|0.64|||Log Rank||||
1646626|NCT01772368|3028895|Superiority||geometric mean ratio|0.339|||||2-Sided|90.0|0.295|0.39||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59|
1646627|NCT01772368|3028895|Superiority||geometric mean ratio|0.795|||||2-Sided|90.0|0.694|0.911||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61|
1646628|NCT01772368|3028895|Superiority||geometric mean ratio|1.534|||||2-Sided|90.0|1.335|1.763||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59|
1646658|NCT01772134|3028938|Superiority or Other||Mean Difference (Net)|0.147|||<|0.001|2-Sided|95.0|0.107|0.187|||Mixed Models Analysis||||
1646629|NCT01772368|3028895|Superiority||geometric mean ratio|3.622|||||2-Sided|90.0|3.149|4.168||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58|
1646630|NCT01772368|3028896|Superiority||LSM difference|0.172|||||2-Sided|90.0|0.151|0.196||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59|
1646631|NCT01772368|3028896|Superiority||geometric mean ratio|0.427|||||2-Sided|90.0|0.376|0.485||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61|
1646632|NCT01772368|3028896|Superiority||geometric mean ratio|0.8|||||2-Sided|90.0|0.702|0.911||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59|
1646633|NCT01772368|3028896|Superiority||geometric mean ratio|1.929|||||2-Sided|90.0|1.69|2.202||||||The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58|
1646634|NCT01772368|3028897|Superiority||LSM difference|-159.01|||<|0.0001|2-Sided|95.0|-213.7|-104.3||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Fp MDPI 100 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646635|NCT01772368|3028897|Superiority||LSM difference|-42.05|||<|0.1311|2-Sided|95.0|-96.7|12.6||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646636|NCT01772368|3028897|Superiority||LSM difference|-0.02|||<|0.9993|2-Sided|95.0|-54.4|54.4||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646637|NCT01772368|3028897|Superiority||LSM difference|39.31|||<|0.1578|2-Sided|95.0|-15.3|94.0||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646638|NCT01772368|3028897|Superiority||LSM difference|67.76|||<|0.015|2-Sided|95.0|13.3|122.2||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646639|NCT01772368|3028897|Superiority||LSM difference|159.01|||<|0.0001|2-Sided|95.0|104.3|213.7||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Advair Diskus 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646640|NCT01772368|3028897|Superiority||LSM difference|116.96|||<|0.0001|2-Sided|95.0|62.4|171.6||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646641|NCT01772368|3028897|Superiority||LSM difference|158.99|||<|0.0001|2-Sided|95.0|104.7|213.3||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646642|NCT01772368|3028897|Superiority||LSM difference|198.32|||<|0.0001|2-Sided|95.0|143.7|252.9||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646643|NCT01772368|3028897|Superiority||LSM difference|226.77|||<|0.0001|2-Sided|95.0|172.4|281.1||significance of 0.05 or alpha of 0.05.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646659|NCT01771991|3028939|Superiority||Mean Difference (Final Values)|2.63|Standard Deviation|17.79||0.57|2-Sided|95.0|-6.65|11.91|||t-test, 2 sided|||Looking at the difference in range of motion change over time. The null hypothesis is there was no difference between the two treatment groups.|
1646712|NCT01769469|3029105|Other|||||||0.8507|||||||Wilcoxon Signed Rank Test||||
1646713|NCT01769469|3029125|Other|||||||0.7986|||||||Wilcoxon Signed Rank Test||||
1646644|NCT01772368|3028898|Superiority||LSM difference|-193.42|||<|0.0001|2-Sided|95.0|-229.5|-157.4||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Fp MDPI 100 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646645|NCT01772368|3028898|Superiority||LSM difference|-41.72|||<|0.0229|2-Sided|95.0|-77.6|-5.8||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646646|NCT01772368|3028898|Superiority||LSM difference|3.42|||<|0.8503|2-Sided|95.0|-32.3|39.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646647|NCT01772368|3028898|Superiority||LSM difference|34.14|||<|0.0624|2-Sided|95.0|-1.8|70.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646648|NCT01772368|3028898|Superiority||LSM difference|57.88|||<|0.0017|2-Sided|95.0|22.0|93.7||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 - Advair Diskus 100/50 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646649|NCT01772368|3028898|Superiority||LSM difference|193.42|||<|0.0001|2-Sided|95.0|157.4|229.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|Advair Diskus 100/50 mcg - Fp MDPI 100|The estimated treatment difference from the ANCOVA model between Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646650|NCT01772368|3028898|Superiority||LSM difference|151.71|||<|0.0001|2-Sided|95.0|115.9|187.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646651|NCT01772368|3028898|Superiority||LSM difference|196.85|||<|0.0001|2-Sided|95.0|161.2|232.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/512.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646652|NCT01772368|3028898|Superiority||LSM difference|227.56|||<|0.0001|2-Sided|95.0|191.6|263.5||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/25 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646653|NCT01772368|3028898|Superiority||LSM difference|251.3|||<|0.0001|2-Sided|95.0|215.6|287.1||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.|FS MDPI 100/50 mcg - Fp MDPI 100 mcg|The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.|
1646654|NCT01772368|3028898|Other|linearity statistical test|||||<|0.0001||||||A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.|ANCOVA|Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.||A linear in log-dose-trend contrast was constructed to evaluate the dose-response trend, where the logarithm of dose was defined precisely as log (dose+1) to accommodate the case of Fp MDPI 100 mcg, since the dose used in this trend analysis was the salmeterol dose. The study was considered positive if the trend test was positive and the test involving the highest FS MDPI dose (100/50 mcg) compared with Fp MDPI 100 mcg was positive, regardless of the results of the tests for the other doses.|
1646655|NCT01772147|3028934|Superiority or Other||Mean Difference (Net)|0.148|||<|0.001|2-Sided|95.0|0.111|0.185|||Mixed Models Analysis||||
1646656|NCT01772147|3028934|Superiority or Other||Mean Difference (Net)|0.127|||<|0.001|2-Sided|95.0|0.089|0.164|||Mixed Models Analysis||||
1646657|NCT01772134|3028938|Superiority or Other||Mean Difference (Net)|0.138|||<|0.001|2-Sided|95.0|0.097|0.178|||Mixed Models Analysis||||
1646660|NCT01771991|3028940|Superiority||Mean Difference (Final Values)|0.17|Standard Deviation|1.5||0.65|2-Sided|95.0|-0.6|0.95|||t-test, 2 sided|||Looking at the difference in pain change over time. The null hypothesis is there was no difference between the two treatment groups.|
1646661|NCT01771991|3028941|Superiority||sum of scores|453.0|Standard Deviation|39.6||0.57|2-Sided||||||Wilcoxon Rank-Sum||Standard Deviation under the Null hypothesis for each group.||
1646662|NCT01771913|3028944|Superiority or Other|||||||0.103|||||||Fisher Exact||||
1646663|NCT01771913|3028945|Superiority or Other|||||||0.026|||||||Wilcoxon (Mann-Whitney)||||
1646664|NCT01771913|3028946|Superiority or Other|||||||0.31|||||||Wilcoxon (Mann-Whitney)||||
1646665|NCT01770860|3028961|Superiority or Other|||||||0.0476|||||||Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect|||
1646666|NCT01770860|3028962|Superiority or Other||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.|||
1646667|NCT01770860|3028963|Superiority or Other||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.|||
1646668|NCT01770860|3028964|Superiority or Other||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.|||
1646669|NCT01770860|3028965|Superiority or Other||||||<|0.0001||||||The p-values presented were for each of the bandage groups compared to no treatment group.|Mixed Models Analysis|P-value is from mixed model with Treatment (trt) as fix effect, and subject as random effect.|||
1646670|NCT01770509|3028987|Superiority or Other|||||||0.645|||||||ANOVA|General Linear Model ANOVA with repeated measures|||
1646671|NCT01770509|3028988|Superiority or Other|||||||0.652|||||||ANOVA|General Linear Model ANOVA with repeated measures|||
1646672|NCT01770431|3028991|Superiority||Hazard Ratio (HR)|0.67|||<|0.0001|2-Sided|95.0|0.55|0.81|||Regression, Cox||||
1646673|NCT01770431|3028992|Superiority||chi-squared|14.7315||||0.0001|2-Sided||||||Cochran-Mantel-Haenszel||||
1646674|NCT01770392|3028993|Superiority or Other||Geometric Mean Ratio in percentage|49.98|Standard Deviation|13.3||1|2-Sided|90.0|46.886|53.286||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)."||
1646675|NCT01770392|3028994|Superiority or Other||Geometric Mean Ratio in percentage|59.76|Standard Deviation|21.9||1|2-Sided|90.0|53.829|66.348||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)."||
1646676|NCT01770392|3028995|Superiority or Other||Geometric Mean Ratio in percentage|50.12|Standard Deviation|12.7||1|2-Sided|90.0|47.155|53.275||p-value for ratio outside interval 0.8 - 1.25|ANOVA|"The model includes fixed effect for treatment and effect subjects was considered as random"|"The standard deviation is actually the geometric coefficient of variation (in %).~The ratio has been calculated as (nintedanib+ rifampicin) divided by nintedanib (in %)"||
1646677|NCT01770379|3028999|Superiority or Other||Odds Ratio (OR)|1.62||||0.1574|2-Sided|95.0|0.83|3.15|||Regression, Logistic||||
1646678|NCT01770379|3028999|Superiority or Other||Odds Ratio (OR)|1.55||||0.2001|2-Sided|95.0|0.79|3.03|||Regression, Logistic||||
1646679|NCT01769586|3029030|Superiority or Other||Risk Difference (RD)|0.38|||<|0.001|2-Sided|95.0|0.24|0.5|||Chi-squared||||
1646680|NCT01769469|3029066|Other|||||||0.7125|||||||Wilcoxon (Mann-Whitney)||||
1646681|NCT01769469|3029067|Other|||||||0.4154|||||||Wilcoxon (Mann-Whitney)||||
1646682|NCT01769469|3029068|Other|||||||0.261|||||||Wilcoxon (Mann-Whitney)||||
1646683|NCT01769469|3029069|Other|||||||0.0277|||||||Wilcoxon (Mann-Whitney)||||
1646684|NCT01769469|3029070|Other|||||||0.0166|||||||Wilcoxon (Mann-Whitney)||||
1646685|NCT01769469|3029071|Other|||||||0.0148|||||||Wilcoxon (Mann-Whitney)||||
1646686|NCT01769469|3029072|Other|||||||0.6285|||||||Wilcoxon (Mann-Whitney)||||
1646687|NCT01769469|3029073|Other|||||||0.2255|||||||Wilcoxon (Mann-Whitney)||||
1646688|NCT01769469|3029074|Other|||||||0.1906|||||||Wilcoxon (Mann-Whitney)||||
1646689|NCT01769469|3029075|Other|||||||0.2926|||||||Wilcoxon (Mann-Whitney)||||
1646690|NCT01769469|3029076|Other|||||||0.537|||||||Wilcoxon (Mann-Whitney)||||
1646691|NCT01769469|3029077|Other|||||||0.2726|||||||Wilcoxon (Mann-Whitney)||||
1646692|NCT01769469|3029078|Other|||||||0.139|||||||Wilcoxon (Mann-Whitney)||||
1646693|NCT01769469|3029079|Other|||||||0.3148|||||||Wilcoxon (Mann-Whitney)||||
1646694|NCT01769469|3029080|Other|||||||0.0719|||||||Wilcoxon (Mann-Whitney)||||
1646695|NCT01769469|3029081|Other|||||||0.8579|||||||Wilcoxon (Mann-Whitney)||||
1646696|NCT01769469|3029082|Other|||||||0.599|||||||Wilcoxon (Mann-Whitney)||||
1646697|NCT01769469|3029083|Other|||||||0.5161|||||||Wilcoxon (Mann-Whitney)||||
1646698|NCT01769469|3029084|Other|||||||0.5491|||||||Wilcoxon (Mann-Whitney)||||
1646699|NCT01769469|3029085|Other|||||||0.4933|||||||Wilcoxon (Mann-Whitney)||||
1646700|NCT01769469|3029086|Other|||||||0.7785|||||||Wilcoxon (Mann-Whitney)||||
1646701|NCT01769469|3029088|Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1646702|NCT01769469|3029089|Other|||||||0.122|||||||Wilcoxon (Mann-Whitney)||||
1646703|NCT01769469|3029090|Other|||||||0.1172|||||||Wilcoxon (Mann-Whitney)||||
1646704|NCT01769469|3029091|Other|||||||0.0238|||||||Wilcoxon (Mann-Whitney)||||
1646705|NCT01769469|3029092|Other|||||||0.5491|||||||Wilcoxon (Mann-Whitney)||||
1646706|NCT01769469|3029093|Other|||||||0.8658|||||||Wilcoxon (Mann-Whitney)||||
1646707|NCT01769469|3029094|Other|||||||0.5782|||||||Wilcoxon (Mann-Whitney)||||
1646708|NCT01769469|3029095|Other|||||||0.1134|||||||Wilcoxon (Mann-Whitney)||||
1646714|NCT01769469|3029126|Other|||||||0.5379|||||||Wilcoxon Signed Rank Test||||
1646715|NCT01769469|3029127|Other|||||||0.7209|||||||Wilcoxon Signed Rank Test||||
1646716|NCT01769469|3029128|Other|||||||0.2431|||||||Wilcoxon Signed Rank Test||||
1646717|NCT01769469|3029129|Other|||||||0.5014|||||||Wilcoxon Signed Rank Test||||
1646718|NCT01769469|3029137|Other|||||||0.8739|||||||Wilcoxon Signed Rank Test||||
1646719|NCT01769469|3029141|Other|||||||0.6545|||||||Wilcoxon Signed Rank Test||||
1646720|NCT01769469|3029152|Superiority|||||||0.0806|||||||Wilcoxon Signed Rank Test||||
1646721|NCT01769469|3029160|Superiority|||||||0.2452|||||||Wilcoxon Signed Rank Test||||
1646722|NCT01769469|3029164|Other|||||||0.2085|||||||Wilcoxon (Mann-Whitney)|||Test of difference at Week 48 from baseline|
1646723|NCT01769456|3029177|Other|||||||0.0236|||||||Wilcoxon Signed Rank Test||||
1646724|NCT01769456|3029178|Other|||||||0.0003|||||||Wilcoxon Signed Rank Test||||
1646725|NCT01769456|3029179|Other|||||||0.0236|||||||Wilcoxon Signed Rank Test||||
1646726|NCT01769456|3029180|Other||||||<|0.0001||||||Reported p-value is the calculated value provided by SAS output.|Wilcoxon Signed Rank Test||||
1646727|NCT01769378|3029226|Superiority or Other||Least Squares Mean Difference|-28.95|Standard Error of the Mean|4.85|<|0.001|2-Sided|95.0|-38.49|-19.4|||Mixed Models Analysis||||
1646728|NCT01769378|3029227|Superiority or Other||Least Squares Mean Difference|-0.23|Standard Error of the Mean|0.16||0.161|2-Sided|95.0|-0.54|0.09||No adjustment for multiplicity|Mixed Models Analysis||||
1646729|NCT01769378|3029228|Superiority or Other||Least Squares Mean Difference|-0.68|Standard Error of the Mean|0.43||0.12|2-Sided|95.0|-1.53|0.18|||Mixed Models Analysis|Sequential gatekeeping strategy was used to adjust for multiplicity.|||
1646730|NCT01769378|3029229|Superiority or Other||Least Squares Mean Difference|-33.54|Standard Error of the Mean|6.6|<|0.001|2-Sided|95.0|-46.55|-20.53|||ANCOVA|Sequential gatekeeping strategy was used to adjust for multiplicity.|||
1646731|NCT01769378|3029230|Superiority or Other||Odds Ratio (OR)|11.45|||<|0.001|2-Sided|95.0|3.71|35.34|||Regression, Logistic|||≤6.5% HbA1c|
1646732|NCT01769378|3029230|Superiority or Other||Odds Ratio (OR)|11.37|||<|0.001|2-Sided|95.0|3.82|33.84|||Regression, Logistic|Sequential gatekeeping strategy was used to adjust for multiplicity.||<7.0% HbA1c|
1646733|NCT01769378|3029231|Superiority or Other||LS Squares Mean Difference|-1.27|Standard Error of the Mean|0.15|<|0.001|2-Sided|95.0|-1.57|-0.97|||Mixed Models Analysis||||
1646734|NCT01769339|3029240|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1646735|NCT01769274|3029255|Other|||||||1|||||||Hierarchical rank test||||
1646736|NCT01769274|3029255|Other|||||||1|||||||Hierarchical rank test||||
1646737|NCT01769196|3029292|Other|The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|0.95||||0.925|2-Sided|95.0|0.3|2.99|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.||
1646738|NCT01769196|3029293|Other|The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|0.99||||0.988|2-Sided|95.0|0.43|2.28|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.||
1646739|NCT01769196|3029294|Other||Hazard Ratio (HR)|1.2||||0.602|2-Sided|95.0|0.61|2.37|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.||
1646740|NCT01769196|3029295|Superiority|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 75th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.2||||0.475|2-Sided|95.0|0.72|2.0|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.||
1646741|NCT01769196|3029296|Superiority|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 50th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.03||||0.851|2-Sided|95.0|0.74|1.43|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.||
1646742|NCT01769196|3029297|Superiority|The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted, sLOXL2 level categories and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.|Hazard Ratio (HR)|1.13||||0.329|2-Sided|95.0|0.88|1.45|||Log Rank||Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.||
1646743|NCT01768676|3029321|Non-Inferiority or Equivalence|If upper limit of 95% CI < 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|0.0|Standard Error of the Mean|0.0|||2-Sided|95.0|0.0|0.0|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.||
1646796|NCT01766050|3029592|Superiority or Other||Adjusted geometric mean ratio|1.036|||||2-Sided|90.0|0.94|1.142||||||AUC (INF)|
1646744|NCT01768676|3029322|Non-Inferiority or Equivalence|If upper limit of 95% CI < 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-2.9|Standard Error of the Mean|2.0|||2-Sided|95.0|-6.8|1.1|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.||
1646745|NCT01768676|3029323|Non-Inferiority or Equivalence|If upper limit of 95% CI < 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-1.4|Standard Error of the Mean|1.4|||2-Sided|95.0|-4.2|1.3|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.||
1646746|NCT01768676|3029324|Non-Inferiority or Equivalence|If upper limit of 95% CI < 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-11.4|Standard Error of the Mean|6.2|||2-Sided|95.0|-23.5|0.7|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.||
1646747|NCT01768676|3029325|Non-Inferiority or Equivalence|The difference in percentage of subjects with a >/= 50% reduction from baseline to Week 26 in sperm concentration between treatment arms was analyzed using Cochran-Mantel-Haenszel method to account for the randomization stratification by baseline sperm concentration. If upper limit of 95% CI < 20% then avanafil is considered non-inferior to placebo.|Risk Difference (RD)|-12.93|Standard Error of the Mean|4.41|||2-Sided|95.0|-21.56|-4.29|||||Confidence interval was only calculated for primary endpoint of the difference between avanafil and placebo, not for each individual arm.||
1646748|NCT01768559|3029343|Superiority or Other||LS Mean Difference|-1.99|Standard Error of the Mean|0.305|<|0.0001|2-Sided|95.0|-2.593|-1.396||Threshold for significance at 0.025 level.|ANCOVA|The superiority was assessed by comparing the P-value at significance level = 0.025 or 0.0125.|Lixisenatide vs Insulin Glulisine TID|Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at α = 0.025 (1-sided) for comparison between lixisenatide vs insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).|
1646749|NCT01768559|3029344|Non-Inferiority or Equivalence|Pre-specified non-inferiority margin of 0.4%.|LS Mean Difference|0.21|Standard Error of the Mean|0.059|||2-Sided|95.0|0.095|0.328|||||Lixisenatide vs Insulin Glulisine TID|Analysis was performed using ANCOVA model as described above. Hochberg procedure was used to control type 1 error at significance level = 0.025 (1-sided) for comparison between Lixisenatide vs Insulin glulisine TID in HbA1c and body weight. If both comparisons were met, then both would be declared significant. Otherwise, if only one was met, then the one met should be tested at α=0.0125 (1-sided).|
1646750|NCT01768559|3029344|Non-Inferiority or Equivalence|Pre-specified non-inferiority margin of 0.4%.|Least Square (LS) Mean Difference|-0.05|Standard Error of the Mean|0.059|||2-Sided|95.0|-0.17|0.064|||||Lixisenatide vs Insulin Glulisine QD|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, strata of Week -1 HbA1c (<8.0, ≥8.0%), randomization strata of metformin use, and country as fixed effects and baseline HbA1c value as a covariate. The non-inferiority was assessed using upper bound of 2-sided 95% Confidence Interval (CI).|
1646751|NCT01768286|3029363|Superiority or Other||||||<|0.001||||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test||||
1646752|NCT01768286|3029363|Superiority or Other||||||<|0.001||||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test||||
1646753|NCT01768286|3029363|Superiority or Other||||||<|0.001||||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test||||
1646754|NCT01768286|3029363|Superiority or Other||||||<|0.001||||||A 2-sided 1-sample binomial test was used to compare over the historical SVR12 rate of 25%. To control the family-wise type I error rate at 0.05, the Hochberg procedure was applied, from which the adjusted p-values were obtained.|Binomial test||||
1646755|NCT01767688|3029438|Superiority or Other||Geometric least-squares mean ratio (GMR)|1.03|||||2-Sided|95.0|0.93|1.15|||||||
1646756|NCT01767688|3029439|Superiority or Other||Geometric least-squares mean ratio (GMR)|0.81|||||2-Sided|95.0|0.51|1.28|||||||
1646757|NCT01767688|3029440|Superiority or Other||Geometric least-squares mean ratio (GMR)|0.94|||||2-Sided|95.0|0.81|1.1|||||||
1646758|NCT01767688|3029441|Superiority or Other||Geometric least-squares mean ratio (GMR)|0.94|||||2-Sided|95.0|0.79|1.11|||||||
1646759|NCT01767597|3029447|Superiority or Other|||||||0.5||||||No p-value adjustments for multiple comparisons were required. Significance was determined using a p-value <0.05.|Chi-squared|||Power calculations were performed to detect >15% difference in immediate linkage-to-care and vaccination. We hypothesized from discussions with an expert panel that ~30% of participants would have appropriate care with standard HBV serology. Assuming type 1 error=0.05 and power=80%, 152 participants per arm would be needed. As ~40% of the population would be nonimmunized or HBsAg-positive from previous data, a minimum 375 participants per arm would be required.|
1646760|NCT01767506|3029456|Superiority||Mean Difference (Final Values)|3.9||||1|2-Sided||||||Fisher Exact||||
1646761|NCT01767506|3029457|Superiority||Odds Ratio (OR)|2.6|||>|0.05|2-Sided|95.0|0.56|11.9|||Regression, Logistic||||The null hypothesis was that we could further decrease infection to 1% or less in more of the communities in the surveillance intervention arm, compared to control communities.
1646762|NCT01767467|3029476|Non-Inferiority|The objective was met if the lower limit of the 95% CI of the Geometric Mean (GM) ratio (GSK1437173A vaccine over placebo) for anti-gE ELISA antibody concentrations at Month 2 was greater than (>) 3.|Adjusted Geometric Mean Concentration|29.75|||<|0.0001|2-Sided|95.0|21.09|41.96||The p-value is relative to the null hypothesis Ho: Vaccine / Placebo = 1|Repeated measurement model|||The objective aimed to evaluate anti-gE humoral immune responses at Month 2 following a two-dose administration of the GSK1437173A vaccine, as compared to placebo, in subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.|
1646797|NCT01766050|3029592|Superiority or Other||Adjusted geometric mean ratio|1.002|||||2-Sided|90.0|0.914|1.098|||||||
1646763|NCT01767376|3029491|Non-Inferiority|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertactin (PRN) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.72|||||2-Sided|95.0|0.59|0.88||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertactin (PRN), one month after Boostrix vaccination.|
1646764|NCT01767376|3029491|Non-Inferiority|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the filamentous haemagglutinin (FHA) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.57|||||2-Sided|95.0|0.5|0.65||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against filamentous haemagglutinin (FHA), one month after Boostrix vaccination.|
1646765|NCT01767376|3029491|Non-Inferiority|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group) for GMC ratios of antibodies against the pertussis (PT) antigen, being greater than or equal to (≥) the predefined limit of 0.67.|Adjusted GMC ratio|0.76|||||2-Sided|95.0|0.66|0.89||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) with respect to geometric mean concentrations (GMCs) of antibodies against pertussis toxoid (PT), one month after Boostrix vaccination.|
1646766|NCT01767376|3029492|Non-Inferiority|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-T concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.|Difference in percentage|-0.44|||||2-Sided|95.0|-2.48|1.26||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-tetanus toxoid (anti-T) antibody concentrations one month after Boostrix vaccination.|
1646767|NCT01767376|3029492|Non-Inferiority|Non-inferiority was defined as the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) between the two groups (Nimenrix+Boostrix Group minus Boostrix Group), in terms of percentage of subjects with anti-D concentrations ≥ 1.0 IU/mL, being greater than or equal to (≥) the pre-defined limit of -10%.|Difference in percentage|-2.14|||||2-Sided|95.0|-7.88|3.53||||||To demonstrate the non-inferiority of Boostrix co-administered with Nimenrix (Nimenrix+Boostrix Group) compared to Boostrix administered alone (Boostrix Group) in terms of anti-diphtheria toxoid (anti-D) antibody concentrations one month after Boostrix vaccination.|
1646768|NCT01767376|3029493|Non-Inferiority|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup Y between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.27|||||2-Sided|95.0|1.02|1.59||||||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup Y, one month after Nimenrix vaccination.|
1646769|NCT01767376|3029493|Non-Inferiority|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup W-135 between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.06|||||2-Sided|95.0|0.86|1.32||||||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup W-135, one month after Nimenrix vaccination.|
1646770|NCT01767376|3029493|Non-Inferiority|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup C between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.12|||||2-Sided|95.0|0.85|1.47||||||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup C, one month after Nimenrix vaccination.|
1646771|NCT01767376|3029493|Non-Inferiority|Non-inferiority was defined as the lower limit (LL) of the two-sided standardised asymptotic 95% confidence interval (CI) for rSBA GMT ratios for serogroup A between the two groups (Nimenrix+Boostrix Group minus Nimenrix Group) being greater than or equal to (≥) the pre-defined limit of 0.5.|Adjusted GMT ratio|1.19|||||2-Sided|95.0|0.97|1.48||||||To demonstrate the non-inferiority of Nimenrix co-administered with Boostrix (Nimenrix+Boostrix Group) compared to Nimenrix administered alone (Nimenrix Group) with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titers (GMTs) for serogroup A, one month after Nimenrix vaccination.|
1646772|NCT01767155|3029507|Other||Odds Ratio (OR)|1.07||||0.6924|2-Sided|95.0|0.76|1.52|||Mantel Haenszel|2-sided||Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test.|
1646773|NCT01767155|3029508|Other||Hazard Ratio (HR)|0.89||||0.3089|2-Sided|95.0|0.71|1.11|||Log Rank|2-sided||Hypothesis testing between the two treatment arms was performed using a log rank test.|
1646774|NCT01767155|3029508|Other||Kaplan-Meier|12.3|||||2-Sided|95.0|6.9|19.3||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months|
1646775|NCT01767155|3029508|Other||Kaplan-Meier|47.5|||||2-Sided|95.0|40.0|54.7||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months|
1646776|NCT01767155|3029508|Other||Kaplan-Meier|20.6|||||2-Sided|95.0|14.6|27.4||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months|
1646777|NCT01767155|3029508|Other||Kaplan-Meier|46.7|||||2-Sided|95.0|39.5|53.6||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months.|
1646778|NCT01767155|3029509|Other||Odds Ratio (OR)|0.87||||0.5907|2-Sided|95.0|0.52|1.45|||Mantel Haenszel|2-sided test||Hypothesis testing between the two treatment arms was performed using a Mantel Haenszel test. The odds ratio and 95% CI of the odds ratio were presented.|
1646779|NCT01767155|3029510|Other||Hazard Ratio (HR)|1.06||||0.5441|2-Sided|95.0|0.87|1.3|||Log Rank|2-sided||A Cox model with treatment effects was used to estimate the hazard ratio and perform hypothesis testing. The estimated hazard ratio and the 95% CI of the hazard ratio were presented.|
1646780|NCT01767155|3029510|Other||Kaplan-Meier|44.6|||||2-Sided|95.0|38.2|50.7||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months|
1646781|NCT01767155|3029510|Other||Kaplan-Meier|72.1|||||2-Sided|95.0|66.0|77.3||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months|
1646782|NCT01767155|3029510|Other||Kaplan-Meier|45.8|||||2-Sided|95.0|39.5|52.0||||||Kaplan-Meier log-log transformed estimates: survivors at 12 months|
1646783|NCT01767155|3029510|Other||Kaplan-Meier|69.8|||||2-Sided|95.0|63.6|75.1||||||Kaplan-Meier log-log transformed estimates: survivors at 6 months|
1646784|NCT01767116|3029513|Superiority or Other||Percentage of Participants|99.5|||||2-Sided|95.0|98.6|100.0|||||95% CI calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides >90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).|
1646785|NCT01767116|3029513|Superiority or Other||Percentage of Participants|100.0|||||2-Sided|95.0|98.2|100.0|||||95% CI calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides >90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).|
1646786|NCT01767116|3029514|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1646787|NCT01767116|3029515|Non-Inferiority or Equivalence|Noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%. The lower confidence bound of the 2-sided 95% CI for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.|Difference in Percentage of Participants|0.5|||||2-Sided|95.0|-0.5|1.4|||||95% CI was calculated using the normal approximation to the binomial distribution.|For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a -10% margin, a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per arm provides >95% power to demonstrate noninferiority of ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV compared with ABT-450/r/ABT-267 and ABT-333, plus RBV (normal approximation of a single binomial proportion in a 1-sample test for superiority).|
1646788|NCT01767116|3029516|Non-Inferiority or Equivalence|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.|Percentage of Participants|99.5|||||2-Sided|95.0|98.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides >95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).|
1646789|NCT01767116|3029516|Non-Inferiority or Equivalence|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.|Percentage of Participants|100.0|||||2-Sided|95.0|98.2|100.0|||||95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%..|For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides >95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).|
1646790|NCT01766401|3029565|Superiority||Least Squares Mean Difference|-1.41||||0.0868|2-Sided|95.0|-3.02|0.2|||MMRM||||
1646791|NCT01766401|3029566|Superiority||Least Squares Mean Difference|-1.5||||0.0438|2-Sided|95.0|-2.96|-0.04|||MMRM||||
1646792|NCT01766310|3029571|Superiority or Other||Mean Difference (Net)|0.68|Standard Deviation|1.3||0.05|2-Sided|95.0|-0.09|1.44|||t-test, 2 sided||||
1646793|NCT01766102|3029581|Other|||||||0.676|||||||t-test, 2 sided|||H0: Operating room time is not significantly different based on mammography type used|
1646794|NCT01766102|3029581|Other|||||||0.716|||||||t-test, 2 sided|||H0: Procedure time is not significantly different based on mammography type used|
1646795|NCT01766076|3029582|Superiority or Other||Mean Difference (Final Values)|28.0|||<|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)|Mann Whitney test was used for nonparametric variables|||
1646798|NCT01766050|3029592|Superiority or Other||Adjusted geometric mean ratio|0.939|||||2-Sided|90.0|0.868|1.017||||||AUC (INF)|
1646799|NCT01766050|3029592|Superiority or Other||Adjusted geometric mean ratio|1.027|||||2-Sided|90.0|0.942|1.12||||||AUC (0-T)|
1646800|NCT01766050|3029592|Superiority or Other||Adjusted geometric mean ratio|0.986|||||2-Sided|90.0|0.902|1.076||||||AUC (0-T)|
1646801|NCT01766050|3029592|Superiority or Other||Adjusted geometric mean ratio|0.941|||||2-Sided|90.0|0.874|1.013||||||AUC (0-T)|
1646802|NCT01766050|3029593|Superiority or Other||Adjusted geometric mean ratio|0.954|||||2-Sided|90.0|0.885|1.028|||||||
1646803|NCT01766050|3029593|Superiority or Other||Adjusted geometric mean ratio|0.922|||||2-Sided|90.0|0.857|0.993|||||||
1646804|NCT01766050|3029593|Superiority or Other||Adjusted geometric mean ratio|0.948|||||2-Sided|90.0|0.88|1.021|||||||
1646805|NCT01766050|3029594|Superiority or Other||Adjusted geometric mean ratio|1.022|||||2-Sided|90.0|0.839|1.245||||||AUC (INF)|
1646806|NCT01766050|3029594|Superiority or Other||Adjusted geometric mean ratio|1.031|||||2-Sided|90.0|0.885|1.2||||||AUC (INF)|
1646807|NCT01766050|3029594|Superiority or Other||Adjusted geometric mean ratio|0.877|||||2-Sided|90.0|0.783|0.982||||||AUC (INF)|
1646808|NCT01766050|3029594|Superiority or Other||Adjusted geometric mean ratio|0.963|||||2-Sided|90.0|0.821|1.13||||||AUC (0-T)|
1646809|NCT01766050|3029594|Superiority or Other||Adjusted geometric mean ratio|1.003|||||2-Sided|90.0|0.856|1.175||||||AUC (0-T)|
1646810|NCT01766050|3029594|Superiority or Other||Adjusted geometric mean ratio|0.915|||||2-Sided|90.0|0.817|1.024||||||AUC (0-T)|
1646811|NCT01766050|3029595|Superiority or Other||Adjusted geometric mean ratio|0.856|||||2-Sided|90.0|0.709|1.034|||||||
1646812|NCT01766050|3029595|Superiority or Other||Adjusted geometric mean ratio|0.922|||||2-Sided|90.0|0.793|1.071|||||||
1646813|NCT01766050|3029595|Superiority or Other||Adjusted geometric mean ratio|0.863|||||2-Sided|90.0|0.746|0.997|||||||
1646814|NCT01766050|3029596|Superiority or Other||Adjusted geometric mean ratio|1.3|||||2-Sided|90.0|1.141|1.482||||||AUC (INF)|
1646815|NCT01766050|3029596|Superiority or Other||Adjusted geometric mean ratio|1.227|||||2-Sided|90.0|1.093|1.379||||||AUC (INF)|
1646816|NCT01766050|3029596|Superiority or Other||Adjusted geometric mean ratio|1.193|||||2-Sided|90.0|1.091|1.304||||||AUC (INF)|
1646817|NCT01766050|3029596|Superiority or Other||Adjusted geometric mean ratio|1.215|||||2-Sided|90.0|1.047|1.41||||||AUC (0-T)|
1646818|NCT01766050|3029596|Superiority or Other||Adjusted geometric mean ratio|1.228|||||2-Sided|90.0|1.092|1.381||||||AUC (0-T)|
1646819|NCT01766050|3029596|Superiority or Other||Adjusted geometric mean ratio|1.159|||||2-Sided|90.0|1.056|1.272||||||AUC (0-T)|
1646820|NCT01766050|3029597|Superiority or Other||Adjusted geometric mean ratio|1.178|||||2-Sided|90.0|0.971|1.429|||||||
1646821|NCT01766050|3029597|Superiority or Other||Adjusted geometric mean ratio|1.292|||||2-Sided|90.0|1.09|1.531|||||||
1646822|NCT01766050|3029597|Superiority or Other||Adjusted geometric mean ratio|1.26|||||2-Sided|90.0|1.118|1.421|||||||
1646823|NCT01766050|3029598|Superiority or Other||Adjusted geometric mean ratio|1.002|||||2-Sided|90.0|0.896|1.121||||||AUC (INF)|
1646824|NCT01766050|3029598|Superiority or Other||Adjusted geometric mean ratio|1.016|||||2-Sided|90.0|0.938|1.101||||||AUC (INF)|
1646825|NCT01766050|3029598|Superiority or Other||Adjusted geometric mean ratio|1.011|||||2-Sided|90.0|0.942|1.085||||||AUC (INF)|
1646826|NCT01766050|3029598|Superiority or Other||Adjusted geometric mean ratio|1.001|||||2-Sided|90.0|0.893|1.121||||||AUC (0-T)|
1646827|NCT01766050|3029598|Superiority or Other||Adjusted geometric mean ratio|1.016|||||2-Sided|90.0|0.936|1.103||||||AUC (0-T)|
1646828|NCT01766050|3029598|Superiority or Other||Adjusted geometric mean ratio|1.013|||||2-Sided|90.0|0.944|1.088||||||AUC (0-T)|
1646829|NCT01766050|3029599|Superiority or Other||Adjusted geometric mean ratio|0.994|||||2-Sided|90.0|0.885|1.116|||||||
1646830|NCT01766050|3029599|Superiority or Other||Adjusted geometric mean ratio|0.911|||||2-Sided|90.0|0.83|1.0|||||||
1646831|NCT01766050|3029599|Superiority or Other||Adjusted geometric mean ratio|0.991|||||2-Sided|90.0|0.898|1.093|||||||
1646832|NCT01766050|3029600|Superiority or Other||Adjusted geometric mean ratio|1.031|||||2-Sided|90.0|0.948|1.121||||||AUC(INF)|
1646833|NCT01766050|3029600|Superiority or Other||Adjusted geometric mean ratio|0.968|||||2-Sided|90.0|0.892|1.049||||||AUC (INF)|
1646834|NCT01766050|3029600|Superiority or Other||Adjusted geometric mean ratio|1.049|||||2-Sided|90.0|0.975|1.127||||||AUC (INF)|
1646835|NCT01766050|3029600|Superiority or Other||Adjusted geometric mean ratio|1.033|||||2-Sided|90.0|0.95|1.123||||||AUC (0-T)|
1646836|NCT01766050|3029600|Superiority or Other||Adjusted geometric mean ratio|0.966|||||2-Sided|90.0|0.889|1.049||||||AUC (0-T)|
1646837|NCT01766050|3029600|Superiority or Other||Adjusted geometric mean ratio|1.05|||||2-Sided|90.0|0.976|1.13||||||AUC (0-T)|
1646838|NCT01766050|3029618|Superiority or Other||Adjusted geometric mean ratio|0.994|||||2-Sided|90.0|0.885|1.116|||||||
1646839|NCT01766050|3029618|Superiority or Other||Adjusted geometric mean ratio|0.911|||||2-Sided|90.0|0.83|1.0|||||||
1646840|NCT01766050|3029618|Superiority or Other||Adjusted geometric mean ratio|0.991|||||2-Sided|90.0|0.898|1.093|||||||
1646841|NCT01765751|3029660|Superiority||Mean Difference (Net)|-2.8|||||2-Sided|95.0|-7.6|2.0|||||Satisfaction with Social Role - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role|
1646842|NCT01765751|3029660|Superiority||Mean Difference (Net)|3.0|||||2-Sided|95.0|-1.8|7.7|||||Satisfaction with Social Role - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role|
1646843|NCT01765751|3029660|Superiority||Mean Difference (Net)|0.2|||||2-Sided|95.0|-4.5|4.9|||||Satisfaction with Social Role - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Satisfaction with Social Role|
1646939|NCT01764386|3029841|Superiority or Other||Mean Difference (Net)|-4.5||||0.0016|2-Sided|95.0|-7.2|-1.7|||ANCOVA||||
1646844|NCT01765751|3029660|Superiority||Mean Difference (Net)|-2.0|||||2-Sided|95.0|-5.4|1.4|||||Depression - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression|
1646845|NCT01765751|3029660|Superiority||Mean Difference (Net)|-0.8|||||2-Sided|95.0|-4.1|2.6|||||Depression - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression|
1646846|NCT01765751|3029660|Superiority||Mean Difference (Net)|-2.8|||||2-Sided|95.0|-6.7|0.6|||||Depression - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Depression|
1646847|NCT01765751|3029660|Superiority||Mean Difference (Net)|-1.4|||||2-Sided|95.0|-5.7|2.9|||||Anxiety - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety|
1646848|NCT01765751|3029660|Superiority||Mean Difference (Net)|1.1|||||2-Sided|95.0|-2.9|5.1|||||Anxiety - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety|
1646849|NCT01765751|3029660|Superiority||Mean Difference (Net)|-0.3|||||2-Sided|95.0|-4.5|3.9|||||Anxiety - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Anxiety|
1646850|NCT01765751|3029660|Superiority||Mean Difference (Net)|2.7|||||2-Sided|95.0|0.4|5.0|||||Sleep Disturbance - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance|
1646851|NCT01765751|3029660|Superiority||Mean Difference (Net)|-1.4|||||2-Sided|95.0|-3.6|0.9|||||Sleep Disturbance - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance|
1646852|NCT01765751|3029660|Superiority||Mean Difference (Net)|1.3|||||2-Sided|95.0|-0.9|3.5|||||Sleep Disturbance - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Sleep Disturbance|
1646853|NCT01765751|3029660|Superiority||Mean Difference (Net)|2.5|||||2-Sided|95.0|-2.3|7.3|||||Fatigue - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue|
1646854|NCT01765751|3029660|Superiority||Median Difference (Net)|3.3|||||2-Sided|95.0|-1.5|8.2|||||Fatigue - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue|
1646855|NCT01765751|3029660|Superiority||Mean Difference (Net)|5.8|||||2-Sided|95.0|1.1|10.5|||||Fatigue - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Fatigue|
1646856|NCT01765751|3029660|Superiority||Mean Difference (Net)|0.7|||||2-Sided|95.0|-2.4|3.7|||||Physical Function- High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population|Physical Function|
1646857|NCT01765751|3029660|Superiority||Mean Difference (Net)|0.1|||||2-Sided|95.0|-2.9|3.2|||||Physical Function - Medium vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Physical Funtion|
1646858|NCT01765751|3029660|Superiority||Mean Difference (Net)|0.8|||||2-Sided|95.0|-2.2|3.8|||||Physical Function - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Physical Function|
1646859|NCT01765751|3029660|Superiority||Mean Difference (Net)|-5.4|||||2-Sided|95.0|-9.8|1.0|||||Pain Interference - High vs. Medium Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference|
1646860|NCT01765751|3029660|Superiority||Mean Difference (Net)|1.5|||||2-Sided|95.0|-2.6|5.6|||||Pain Interference - Medium vs Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference|
1646861|NCT01765751|3029660|Superiority||Mean Difference (Net)|-3.9|||||2-Sided|95.0|-8.1|0.4|||||Pain Interference - High vs. Low Group - The scale for the PROMIS measures uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.|Pain Interference|
1646862|NCT01765751|3029661|Superiority||Mean Difference (Final Values)|5.8|||||2-Sided|95.0|-8.6|20.3|||||High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.||
1646863|NCT01765751|3029661|Superiority||Mean Difference (Final Values)|9.8|||||2-Sided|95.0|-3.7|23.3|||||Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.||
1646864|NCT01765751|3029661|Superiority||Mean Difference (Final Values)|15.6|||||2-Sided|95.0|1.6|29.7|||||High vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.||
1646865|NCT01765751|3029662|Superiority||Mean Difference (Final Values)|-0.2|||||2-Sided|95.0|-3.2|2.7|||||High vs Medium group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.||
1646866|NCT01765751|3029662|Superiority||Mean Difference (Final Values)|3.0|||||2-Sided|95.0|0.1|5.9|||||Medium vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.||
1646867|NCT01765751|3029662|Superiority||Mean Difference (Final Values)|2.7|||||2-Sided|95.0|-0.1|5.6|||||High vs Low group, mean difference adjusted for the baseline value of the respective variable centered at its mean. NDI also adjusted for traction-force feedback method.||
1646868|NCT01765673|3029664|Other|||||||0.744|||||||paired t test||||
1646869|NCT01765673|3029665|Other|||||||0.373|||||||paired t test||||
1646870|NCT01765673|3029666|Other|||||||0.396|||||||paired t test||||
1646871|NCT01765673|3029667|Other|||||||0.067|||||||paired t test||||
1646872|NCT01765673|3029668|Other|||||||0.03|||||||paired t test||||
1646873|NCT01765673|3029669|Other|||||||0.239|||||||paired t test||||
1646874|NCT01765673|3029670|Other|||||||0.121|||||||paired t test||||
1646875|NCT01765673|3029671|Other|||||||0.229|||||||paired t test||||
1646876|NCT01765673|3029672|Other|||||||0.152|||||||paired t test||||
1646877|NCT01765673|3029673|Other|||||||0.088|||||||paired t test||||
1646878|NCT01765673|3029674|Other|||||||0.827|||||||paired t test||||
1646879|NCT01765673|3029675|Other|||||||0.052|||||||paired t test||||
1646880|NCT01765673|3029676|Other|||||||0.16|||||||paired t test||||
1646881|NCT01765673|3029677|Other|||||||0.086|||||||paired t test||||
1646882|NCT01765673|3029678|Other|||||||0.038|||||||paired t test||||
1646883|NCT01765673|3029679|Other|||||||0.418|||||||paired t test||||
1646884|NCT01765673|3029680|Other|||||||0.719|||||||paired t test||||
1646885|NCT01765673|3029681|Other|||||||0.022|||||||paired t test||||
1646886|NCT01765673|3029682|Other|||||||0.017|||||||paired t test||||
1646887|NCT01765673|3029683|Other|||||||0.218|||||||paired t test||||
1646888|NCT01765582|3029693|Superiority or Other||Hazard Ratio (HR)|0.68||||0.005|2-Sided|90.0|0.53|0.88|||Log Rank|||Stratified by extent of metastatic disease (liver-limited disease vs. non-liver-limited disease) and tumor location (right vs. left) after correction post-randomization.|
1646889|NCT01765582|3029694|Superiority or Other||Odds Ratio (OR)|1.62||||0.132|2-Sided|90.0|0.96|2.71|||Cochran-Mantel-Haenszel|||Stratified by extent of metastatic disease (liver-limited disease versus non liver-limited disease) and tumor location (right versus left) after correction post-randomization.|
1646890|NCT01765569|3029698|Superiority or Other||Geometric Mean Ratio|1.47|||||2-Sided|90.0|1.3|1.65|||||||
1646891|NCT01765569|3029702|Superiority or Other||Geometric Mean Ratio|1.82|||||2-Sided|90.0|1.63|2.02|||||||
1646892|NCT01765543|3029708|Superiority or Other||Geometric Mean Ratio|1.11|||||2-Sided|90.0|0.908|1.36||||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.|
1646893|NCT01765543|3029709|Superiority or Other||Geometric Mean Ratio|0.596|||||2-Sided|90.0|0.469|0.759||||||ANOVA was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.|
1646894|NCT01765543|3029710|Superiority or Other||Geometric Mean Ratio|0.614|||||2-Sided|90.0|0.484|0.78||||||Analysis of variance (ANOVA) was applied to the log-transformed PK parameters, and then back transformed to provide geometric mean ratio (Period C/Period A) and confidence intervals.|
1646895|NCT01765192|3029737|Superiority or Other||LS Mean Difference|-0.09|Standard Error of the Mean|0.075||0.217|2-Sided|95.0|-0.2426|0.0563||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Nighttime Asthma Symptoms measurement as the covariate.|ANCOVA||||
1646896|NCT01765192|3029738|Superiority or Other||LS Mean Difference|-0.21|Standard Error of the Mean|0.089||0.025|2-Sided|95.0|-0.385|-0.0271||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Daytime Asthma Symptom Score as the covariate.|ANCOVA||||
1646897|NCT01765192|3029739|Superiority or Other||LS Mean Difference|13.62|Standard Error of the Mean|5.206||0.011|2-Sided|95.0|3.1896|24.0553||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator PEF measurement as the covariate.|ANCOVA||||
1646898|NCT01765192|3029740|Superiority or Other||LS Mean Difference|7.21|Standard Error of the Mean|15.105||0.635||95.0|-23.0531|37.466||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator PEF measurement as the covariate.|ANCOVA||||
1646899|NCT01765192|3029741|Superiority or Other||LS Mean Difference|0.12|Standard Error of the Mean|0.056||0.032|2-Sided|95.0|0.0113|0.2364||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator FEF measurement as the covariate.|ANCOVA||||
1646900|NCT01765192|3029742|Superiority or Other||LS Mean Difference|0.06|Standard Error of the Mean|0.04||0.129|2-Sided|95.0|-0.0185|0.1422||P-values were obtained using an ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline pre-bronchodilator FVC measurement as the covariate.|ANCOVA||||
1646901|NCT01765192|3029743|Superiority or Other||Least Squares (LS) Mean Difference|0.1|Standard Error of the Mean|0.039||0.013|2-Sided|95.0|0.0219|0.1795|||ANCOVA|||The primary endpoint was analyzed using an analysis of covariance model adapted for the crossover design. The following fixed factors and covariates were included in the model: Treatment, sequence, period, and baseline FEV1 measurement of the respective treatment period. The reported analysis results are for the 2 crossover treatment periods combined.|
1646902|NCT01765153|3029791|Superiority or Other|||||||0.04366667|||||||t-test, 2 sided||||
1646903|NCT01764945|3029799|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|92.91|Standard Deviation|12.0|||2-Sided|90.0|88.42|97.63|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."|
1646904|NCT01764945|3029799|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|94.38|Standard Deviation|12.4|||2-Sided|90.0|89.76|99.24|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."|
1646905|NCT01764945|3029799|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|91.59|Standard Deviation|11.0|||2-Sided|90.0|87.53|95.84|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."|
1646906|NCT01764945|3029799|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|79.6|Standard Deviation|10.2|||2-Sided|90.0|74.84|84.67|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."|
1646907|NCT01764945|3029799|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|80.93|Standard Deviation|14.5|||2-Sided|90.0|74.58|87.83|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."|
1646908|NCT01764945|3029799|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|82.02|Standard Deviation|13.1|||2-Sided|90.0|75.98|88.55|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."|
1646909|NCT01764945|3029800|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.09|Standard Deviation|29.4|||2-Sided|90.0|69.35|87.94|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."|
1646910|NCT01764945|3029800|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.43|Standard Deviation|30.4|||2-Sided|90.0|69.54|88.46|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."|
1646911|NCT01764945|3029800|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.3|Standard Deviation|22.5|||2-Sided|90.0|71.42|85.84|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."|
1646912|NCT01764945|3029800|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|78.76|Standard Deviation|22.7|||2-Sided|90.0|68.94|89.99|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."|
1646913|NCT01764945|3029800|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|73.23|Standard Deviation|26.2|||2-Sided|90.0|63.33|84.68|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."|
1646914|NCT01764945|3029800|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|74.07|Standard Deviation|21.5|||2-Sided|90.0|65.44|83.83|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."|
1646915|NCT01764945|3029801|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|94.44|Standard Deviation|12.0|||2-Sided|90.0|89.88|99.24|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment H : treatment E)."|
1646916|NCT01764945|3029801|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|96.37|Standard Deviation|12.7|||2-Sided|90.0|91.55|101.43|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment G : treatment E)."|
1646917|NCT01764945|3029801|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|92.9|Standard Deviation|10.5|||2-Sided|90.0|88.94|97.04|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 120 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment F : treatment E)."|
1646918|NCT01764945|3029801|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|83.92|Standard Deviation|19.6|||2-Sided|90.0|74.69|94.28|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment D : treatment A)."|
1646919|NCT01764945|3029801|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|83.34|Standard Deviation|22.2|||2-Sided|90.0|73.65|94.3|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment C : treatment A)."|
1646920|NCT01764945|3029801|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing).|Geometric Mean Ratio|82.58|Standard Deviation|19.7|||2-Sided|90.0|73.69|92.54|||||the standard deviation is actually the geometric coefficient of variation.|"relative bioavailability comparison of 40 mg faldaprevir soft gelatine capsules compared with the equivalent dose of an oral solution.~(treatment B : treatment A)."|
1646940|NCT01764386|3029842|Superiority or Other||Mean Difference (Net)|2.0||||0.0913|2-Sided|95.0|-0.3|4.3|||ANCOVA||||
1646941|NCT01764386|3029843|Superiority or Other||Mean Difference (Net)|-0.4||||0.716|2-Sided|95.0|-2.6|1.8|||ANCOVA||||
1646921|NCT01764841|3029813|Superiority or Other||Incidence Rate Ratio|0.7329||||0.0382|2-Sided|97.5|0.5237|1.0256|||Poisson regression|||A Poisson regression with adjustment for over-/under dispersion was used to analyze the number of exacerbation events over 48 weeks and to test the difference in the frequency of exacerbation between Ciprofloxacin DPI 14 and Pooled placebo group. P-value was analyzed using Wald-type test along with the incidence rate ratio of the comparison.|
1646922|NCT01764841|3029813|Superiority or Other||Incidence Rate Ratio|0.8615||||0.2944|2-Sided|97.5|0.6264|1.1848|||Poisson regression|||A Poisson regression with adjustment for over-/under dispersion was used to analyze the number of exacerbation events over 48 weeks and to test the difference in the frequency of exacerbation between Ciprofloxacin DPI 28 and Pooled placebo group. P-value was analyzed using Wald-type test along with the incidence rate ratio of the comparison.|
1646923|NCT01764841|3029814|Superiority or Other||Hazard Ratio (HR)|0.5333||||0.0005|2-Sided|97.5|0.3568|0.7971|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 97.5% CI was calculated by using Cox proportional hazards model by comparison of Cipro 14/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.|
1646924|NCT01764841|3029814|Superiority or Other||Hazard Ratio (HR)|0.7331||||0.065|2-Sided|97.5|0.5027|1.069|||Wald-type test|||The hazard ratio for time to first exacerbation event within 48 weeks and 97.5% Confidence Interval (CI) was calculated by using Cox proportional hazards model by comparison of Cipro 28/Pooled Placebo reporting groups. P-value was analysed using Wald-type test.|
1646925|NCT01764633|3029819|Superiority||Hazard Ratio (HR)|0.77||||0.0035|2-Sided|95.0|0.65|0.92|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.|
1646926|NCT01764633|3029820|Superiority||Hazard Ratio (HR)|0.98||||0.8179|2-Sided|95.0|0.86|1.13|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.|
1646927|NCT01764633|3029821|Superiority||Hazard Ratio (HR)|0.78|||<|0.0001|2-Sided|95.0|0.71|0.86|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.|
1646928|NCT01764633|3029822|Superiority||Hazard Ratio (HR)|0.79||||0.0101|2-Sided|95.0|0.66|0.95|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.|
1646929|NCT01764633|3029823|Superiority||Hazard Ratio (HR)|0.73|||<|0.0001|2-Sided|95.0|0.65|0.82|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint of cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints were tested at an overall significance level of 0.01 by applying the Hochberg method.|
1646930|NCT01764633|3029824|Superiority||Hazard Ratio (HR)|1.04||||0.5368|2-Sided|95.0|0.91|1.19|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary, key secondary, and endpoint cardiovascular death reached a statistical significance level of 0.05, then the endpoint of all-cause death was tested at a significance level of 0.04 and remaining secondary endpoints at an overall significant level of 0.01 by applying the Hochberg method.|
1646931|NCT01764633|3029825|Superiority||Hazard Ratio (HR)|1.05||||0.6188|2-Sided|95.0|0.88|1.25|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary and key secondary endpoints reached a statistical significance level of 0.05, then the endpoint of cardiovascular death was tested at a significance level of 0.05.|
1646932|NCT01764633|3029826|Superiority||Hazard Ratio (HR)|0.8|||<|0.0001|2-Sided|95.0|0.73|0.88|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|If the primary endpoint reached statistical significance at the 0.05 level, the key secondary endpoint (composite of cardiovascular death, myocardial infarction, and stroke) was tested at a significance level of 0.05.|
1646933|NCT01764633|3029827|Superiority||Hazard Ratio (HR)|0.85|||<|0.0001|2-Sided|95.0|0.79|0.92|||Log Rank|Two-sided log-rank test stratified by randomization stratification factors (final screening LDL-C level and region).|Based on a Cox model stratified by the randomization stratification factors.|The primary endpoint was compared between treatment groups at a significance level of 0.05.|
1646934|NCT01764386|3029836|Superiority or Other||Mean Difference (Net)|17.4|||<|0.0001|2-Sided|95.0|13.45|21.36|||ANCOVA||||
1646935|NCT01764386|3029837|Superiority or Other||Mean Difference (Net)|-2.1|||<|0.0001|2-Sided|95.0|-3.1|-1.1|||ANCOVA||||
1646936|NCT01764386|3029838|Superiority or Other||Mean Difference (Net)|-7.9|||<|0.0001|2-Sided|95.0|-9.8|-6.0|||ANCOVA||||
1646937|NCT01764386|3029839|Superiority or Other||Mean Difference (Net)|-1.2||||0.0003|2-Sided|95.0|-1.7|-0.7|||ANCOVA||||
1646938|NCT01764386|3029840|Superiority or Other||Mean Difference (Net)|-4.1||||0.0004|2-Sided|95.0|-6.2|-2.0|||ANCOVA||||
1646942|NCT01764386|3029844|Superiority or Other||Mean Difference (Net)|-2.0||||0.1706|2-Sided|95.0|-4.9|0.9|||ANCOVA||||
1646943|NCT01764386|3029845|Superiority or Other||Mean Difference (Net)|4.0||||0.0001|2-Sided|95.0|1.99|6.06|||ANCOVA||||
1646944|NCT01764386|3029846|Superiority or Other||Mean Difference (Net)|-0.1||||0.9686|2-Sided|95.0|-5.96|5.73|||ANCOVA||||
1646945|NCT01764386|3029847|Superiority or Other||Mean Difference (Net)|-16.4||||0.0019|2-Sided|95.0|-29.5|-3.3|||ANCOVA||||
1646946|NCT01764386|3029848|Superiority or Other||Mean Difference (Net)|-5.32|||<|0.0001|2-Sided|95.0|-7.14|-3.5|||ANCOVA||||
1646947|NCT01764386|3029849|Superiority or Other||Mean Difference (Net)|-8.65|||<|0.0001|2-Sided|95.0|-10.07|-7.24|||ANCOVA||||
1646948|NCT01764386|3029851|Superiority or Other||Odds Ratio (OR)|21.4|||<|0.0001|2-Sided|95.0|6.0|76.7|||Regression, Logistic||||
1646949|NCT01764386|3029852|Superiority or Other||Odds Ratio (OR)|44.0|||<|0.0001|2-Sided|95.0|16.6|116.3|||Regression, Logistic||||
1646950|NCT01764386|3029853|Superiority or Other||Mean Difference (Net)|-8.52|||<|0.0001|2-Sided|95.0|-9.88|-7.15|||ANCOVA||||
1646951|NCT01764256|3029858|Equivalence|Equivalence was defined as p<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)|
1646952|NCT01764256|3029858|Equivalence|Equivalence was defined as p<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)|
1646953|NCT01764256|3029858|Equivalence|Equivalence was defined as p<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)|
1646954|NCT01764256|3029859|Equivalence|Equivalence was defined as p<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)|
1646955|NCT01764256|3029859|Equivalence|Equivalence defined as p<0.05||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)|
1646956|NCT01764256|3029859|Equivalence|Equivalence was defined as p<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)|
1646957|NCT01764256|3029860|Equivalence|Equivalence was defined as p<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)|
1646958|NCT01764256|3029860|Equivalence|Equivalence was defined as p<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)|
1646959|NCT01764256|3029860|Equivalence|Equivalence was defined as p<0.05.||||||0.6004|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)|
1646960|NCT01764256|3029861|Equivalence|Equivalence was defined as p<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)|
1646961|NCT01764256|3029861|Equivalence|Equivalence was defined as p<0.05.||||||1|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)|
1646962|NCT01764256|3029861|Equivalence|Equivalence was defined as p<0.05.||||||0.5694|||||||Fisher Exact|||Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)|
1646963|NCT01764256|3029862|Equivalence|Definition of equivalence: p<0.05||||||0.7446|||||||Fisher Exact|||Proportion of subjects with at least one unsolicited adverse event: potentially related|
1646964|NCT01764256|3029862|Equivalence|Definition of equivalence: p<0.05||||||0.44|||||||Fisher Exact|||Proportion of subjects with at least one unsolicited adverse event (related or unrelated)|
1646965|NCT01763996|3029887|Superiority or Other||LS Mean Difference|1.8||||0.756|2-Sided|95.0|-10.1|13.76||0.05 level of significance|ANOVA|Analysis of variance (ANOVA) model that includes sequence, period, and treatment as fixed factors and subjects within sequence as a random factor.|||
1646966|NCT01763918|3029890|Superiority or Other||LS Mean Treatment Difference|-9.17|Standard Error of the Mean|4.98|<|0.001|2-Sided|95.0|-19.01|0.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646967|NCT01763918|3029890|Superiority or Other||LS Mean Treatment Difference|-20.97|Standard Error of the Mean|4.21|<|0.001|2-Sided|95.0|-29.29|-12.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646968|NCT01763918|3029891|Superiority or Other||LS Mean Treatment Difference|-15.54|Standard Error of the Mean|3.9|<|0.001|2-Sided|95.0|-23.25|-7.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646969|NCT01763918|3029891|Superiority or Other||LS Mean Treatment Difference|-22.63|Standard Error of the Mean|3.46|<|0.001|2-Sided|95.0|-29.46|-15.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646970|NCT01763918|3029892|Superiority or Other||LS Mean Treatment Difference|9.07|Standard Error of the Mean|2.83|<|0.001|2-Sided|95.0|3.48|1466.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646971|NCT01763918|3029892|Superiority or Other||LS Mean Treatment Difference|9.2|Standard Error of the Mean|2.3|<|0.001|2-Sided|95.0|4.66|13.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647502|NCT01762761|3030097|Superiority or Other (legacy)||||||<|0.001|||||||van Elteren stratified rank test||||
1647503|NCT01762761|3030098|Superiority or Other (legacy)||||||<|0.001|||||||van Elteren stratified rank test||||
1646972|NCT01763918|3029893|Superiority or Other||LS Mean Treatment Difference|9.48|Standard Error of the Mean|2.21|<|0.001|2-Sided|95.0|5.1|13.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646973|NCT01763918|3029893|Superiority or Other||LS Mean Treatment Difference|8.38|Standard Error of the Mean|2.04|<|0.001|2-Sided|95.0|4.36|12.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646974|NCT01763918|3029894|Superiority or Other||LS Mean Treatment Difference|-11.56|Standard Error of the Mean|4.97|<|0.001|2-Sided|95.0|-21.38|-1.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646975|NCT01763918|3029894|Superiority or Other||LS Mean Treatment Difference|-19.59|Standard Error of the Mean|4.22|<|0.001|2-Sided|95.0|-27.92|-11.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646976|NCT01763918|3029895|Superiority or Other||LS Mean Treatment Difference|-16.74|Standard Error of the Mean|3.89|<|0.001|2-Sided|95.0|-24.43|-9.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646977|NCT01763918|3029895|Superiority or Other||LS Mean Treatment Difference|-22.36|Standard Error of the Mean|3.6|<|0.001|2-Sided|95.0|-29.48|-15.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646978|NCT01763918|3029896|Superiority or Other||LS Mean Treatment Difference|-28.24|Standard Error of the Mean|3.73|<|0.001|2-Sided|95.0|-35.61|-20.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646979|NCT01763918|3029896|Superiority or Other||LS Mean Treatment Difference|-31.57|Standard Error of the Mean|3.9|<|0.001|2-Sided|95.0|-39.28|-23.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646980|NCT01763918|3029897|Superiority or Other||LS Mean Treatment Difference|-31.0|Standard Error of the Mean|3.5|<|0.001|2-Sided|95.0|-37.91|-24.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646981|NCT01763918|3029897|Superiority or Other||LS Mean Treatment Difference|-31.37|Standard Error of the Mean|3.52|<|0.001|2-Sided|95.0|-38.33|-24.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646982|NCT01763918|3029898|Superiority or Other||LS Mean Treatment Difference|-49.55|Standard Error of the Mean|4.35|<|0.001|2-Sided|95.0|-58.14|-40.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646983|NCT01763918|3029898|Superiority or Other||LS Mean Treatment Difference|-54.28|Standard Error of the Mean|2.97|<|0.001|2-Sided|95.0|-60.16|-48.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646984|NCT01763918|3029899|Superiority or Other||LS Mean Treatment Difference|-55.56|Standard Error of the Mean|2.79|<|0.001|2-Sided|95.0|-61.08|-50.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646985|NCT01763918|3029899|Superiority or Other||LS Mean Treatment Difference|-53.17|Standard Error of the Mean|2.62|<|0.001|2-Sided|95.0|-58.35|-47.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646986|NCT01763918|3029900|Superiority or Other||LS Mean Treatment Difference|-45.42|Standard Error of the Mean|3.77|<|0.001|2-Sided|95.0|-52.86|-37.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646987|NCT01763918|3029900|Superiority or Other||LS Mean Treatment Difference|-46.08|Standard Error of the Mean|2.63|<|0.001|2-Sided|95.0|-51.27|-40.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646988|NCT01763918|3029901|Superiority or Other||LS Mean Treatment Difference|-49.16|Standard Error of the Mean|2.56|<|0.001|2-Sided|95.0|-54.21|-44.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647504|NCT01762761|3030099|Superiority or Other (legacy)||Odds Ratio (OR)|16.54||||0.008|2-Sided|95.0|2.09|131.12|||Regression, Logistic||||
1646989|NCT01763918|3029901|Superiority or Other||LS Mean Treatment Difference|-46.59|Standard Error of the Mean|2.45|<|0.001|2-Sided|95.0|-51.43|-41.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646990|NCT01763918|3029902|Superiority or Other||LS Mean Treatment Difference|-49.41|Standard Error of the Mean|3.19|<|0.001|2-Sided|95.0|-55.73|-43.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646991|NCT01763918|3029902|Superiority or Other||LS Mean Treatment Difference|-49.09|Standard Error of the Mean|2.76|<|0.001|2-Sided|95.0|-54.55|-43.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646992|NCT01763918|3029903|Superiority or Other||LS Mean Treatment Difference|-54.98|Standard Error of the Mean|2.33|<|0.001|2-Sided|95.0|-59.58|-50.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646993|NCT01763918|3029903|Superiority or Other||LS Mean Treatment Difference|-49.39|Standard Error of the Mean|2.5|<|0.001|2-Sided|95.0|-54.32|-44.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646994|NCT01763918|3029904|Superiority or Other||LS Mean Treatment Difference|-54.95|Standard Error of the Mean|3.54|<|0.001|2-Sided|95.0|-61.95|-47.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646995|NCT01763918|3029904|Superiority or Other||LS Mean Treatment Difference|-54.79|Standard Error of the Mean|2.87|<|0.001|2-Sided|95.0|-60.47|-49.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646996|NCT01763918|3029905|Superiority or Other||LS Mean Treatment Difference|-60.01|Standard Error of the Mean|2.65|<|0.001|2-Sided|95.0|-65.24|-54.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646997|NCT01763918|3029905|Superiority or Other||LS Mean Treatment Difference|-56.0|Standard Error of the Mean|2.74|<|0.001|2-Sided|95.0|-61.41|-50.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1646998|NCT01763918|3029906|Superiority or Other||Treatment Difference|60.9|||<|0.001|2-Sided|95.0|47.6|69.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.|||
1646999|NCT01763918|3029906|Superiority or Other||Treatment Difference|66.3|||<|0.001|2-Sided|95.0|53.7|74.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use|||
1647000|NCT01763918|3029907|Superiority or Other||Treatment Difference|78.5|||<|0.001|2-Sided|95.0|66.9|85.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.|||
1647001|NCT01763918|3029907|Superiority or Other||Treatment Difference|65.1|||<|0.001|2-Sided|95.0|52.8|73.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and ezetimibe use.|||
1647002|NCT01763918|3029908|Superiority or Other||LS Mean Treatment Difference|-91.3|Standard Error of the Mean|6.3|<|0.001|2-Sided|95.0|-103.8|-78.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647003|NCT01763918|3029908|Superiority or Other||LS Mean Treatment Difference|-92.9|Standard Error of the Mean|5.1|<|0.001|2-Sided|95.0|-102.9|-82.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647004|NCT01763918|3029909|Superiority or Other||LS Mean Treatment Difference|-97.4|Standard Error of the Mean|4.9|<|0.001|2-Sided|95.0|-107.1|-87.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647005|NCT01763918|3029909|Superiority or Other||LS Mean Treatment Difference|-95.2|Standard Error of the Mean|5.0|<|0.001|2-Sided|95.0|-105.1|-85.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647019|NCT01763905|3029916|Superiority or Other||LS Mean Treatment Difference|5.15|Standard Error of the Mean|2.23||0.068|2-Sided|95.0|0.74|9.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647505|NCT01762761|3030100|Superiority or Other (legacy)||Odds Ratio (OR)|0.13|||<|0.001|2-Sided|95.0|0.05|0.37|||Regression, Logistic||||
1647006|NCT01763918|3029910|Superiority or Other||LS Mean Treatment Difference|-65.55|Standard Error of the Mean|2.9|<|0.001|2-Sided|95.0|-71.27|-59.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647007|NCT01763918|3029910|Superiority or Other||LS Mean Treatment Difference|-60.15|Standard Error of the Mean|2.88|<|0.001|2-Sided|95.0|-65.83|-54.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647008|NCT01763918|3029911|Superiority or Other||LS Mean Treatment Difference|-61.27|Standard Error of the Mean|3.91|<|0.001|2-Sided|95.0|-69.0|-53.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647009|NCT01763918|3029911|Superiority or Other||LS Mean Treatment Difference|-59.23|Standard Error of the Mean|2.98|<|0.001|2-Sided|95.0|-65.11|-53.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C and ezetimibe use, scheduled visit, and the interaction of treatment with scheduled visit.||Within each dose frequency, the null hypothesis was that there was no mean difference in the percent change from baseline at week 12 or in the percent change from baseline at the mean of weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647010|NCT01763905|3029912|Superiority or Other||LS Mean Treatment Difference|-38.69|Standard Error of the Mean|2.21|<|0.001|2-Sided|95.0|-43.06|-34.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.|
1647011|NCT01763905|3029912|Superiority or Other||LS Mean Treatment Difference|-36.9|Standard Error of the Mean|2.71|<|0.001|2-Sided|95.0|-42.26|-31.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.|
1647012|NCT01763905|3029913|Superiority or Other||LS Mean Treatment Difference|0.08|Standard Error of the Mean|5.72||0.33|2-Sided|95.0|-11.24|11.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647013|NCT01763905|3029913|Superiority or Other||LS Mean Treatment Difference|-0.67|Standard Error of the Mean|4.7||0.97|2-Sided|95.0|-9.96|8.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647014|NCT01763905|3029914|Superiority or Other||LS Mean Treatment Difference|-3.53|Standard Error of the Mean|4.85||0.33|2-Sided|95.0|-13.12|6.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647015|NCT01763905|3029914|Superiority or Other||LS Mean Treatment Difference|-1.84|Standard Error of the Mean|4.35||0.97|2-Sided|95.0|-10.43|6.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647016|NCT01763905|3029915|Superiority or Other||LS Mean Treatment Difference|4.83|Standard Error of the Mean|2.52||0.13|2-Sided|95.0|-0.16|9.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647017|NCT01763905|3029915|Superiority or Other||LS Mean Treatment Difference|3.57|Standard Error of the Mean|2.56||0.068|2-Sided|95.0|-1.49|8.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647018|NCT01763905|3029916|Superiority or Other||LS Mean Treatment Difference|5.74|Standard Error of the Mean|2.28||0.13|2-Sided|95.0|1.23|10.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647506|NCT01762761|3030101|Superiority or Other (legacy)||Hazard Ratio (HR)|6.12|||<|0.001|2-Sided|95.0|4.01|9.34|||Log Rank||||
1647020|NCT01763905|3029917|Superiority or Other||LS Mean Treatment Difference|-4.69|Standard Error of the Mean|6.25||0.33|2-Sided|95.0|-17.04|7.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647021|NCT01763905|3029917|Superiority or Other||LS Mean Treatment Difference|1.58|Standard Error of the Mean|4.92||0.97|2-Sided|95.0|-8.14|11.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647022|NCT01763905|3029918|Superiority or Other||LS Mean Treatment Difference|-6.42|Standard Error of the Mean|5.13||0.33|2-Sided|95.0|-16.55|3.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647023|NCT01763905|3029918|Superiority or Other||LS Mean Treatment Difference|-2.59|Standard Error of the Mean|4.45||0.97|2-Sided|95.0|-11.38|6.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647024|NCT01763905|3029919|Superiority or Other||LS Mean Treatment Difference|-27.88|Standard Error of the Mean|5.73|<|0.001|2-Sided|95.0|-39.21|-16.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647025|NCT01763905|3029919|Superiority or Other||LS Mean Treatment Difference|-25.29|Standard Error of the Mean|4.03|<|0.001|2-Sided|95.0|-33.26|-17.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647026|NCT01763905|3029920|Superiority or Other||LS Mean Treatment Difference|-25.26|Standard Error of the Mean|4.3|<|0.001|2-Sided|95.0|-33.75|-16.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647027|NCT01763905|3029920|Superiority or Other||LS Mean Treatment Difference|-23.9|Standard Error of the Mean|3.73|<|0.001|2-Sided|95.0|-31.27|-16.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647028|NCT01763905|3029921|Superiority or Other||LS Mean Treatment Difference|-34.13|Standard Error of the Mean|2.91|<|0.001|2-Sided|95.0|-39.87|-28.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647029|NCT01763905|3029921|Superiority or Other||LS Mean Treatment Difference|-34.53|Standard Error of the Mean|2.79|<|0.001|2-Sided|95.0|-40.05|-29.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647030|NCT01763905|3029922|Superiority or Other||LS Mean Treatment Difference|-36.37|Standard Error of the Mean|2.71|<|0.001|2-Sided|95.0|-41.73|-31.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647031|NCT01763905|3029922|Superiority or Other||LS Mean Treatment Difference|-34.86|Standard Error of the Mean|2.52|<|0.001|2-Sided|95.0|-39.84|-29.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647032|NCT01763905|3029923|Superiority or Other||LS Mean Treatment Difference|-28.66|Standard Error of the Mean|2.64|<|0.001|2-Sided|95.0|-33.88|-23.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647033|NCT01763905|3029923|Superiority or Other||LS Mean Treatment Difference|-26.28|Standard Error of the Mean|2.6|<|0.001|2-Sided|95.0|-31.42|-21.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647034|NCT01763905|3029924|Superiority or Other||LS Mean Treatment Difference|-29.94|Standard Error of the Mean|2.42|<|0.001|2-Sided|95.0|-34.72|-25.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647035|NCT01763905|3029924|Superiority or Other||LS Mean Treatment Difference|-27.39|Standard Error of the Mean|2.39|<|0.001|2-Sided|95.0|-32.11|-22.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647036|NCT01763905|3029925|Superiority or Other||LS Mean Treatment Difference|-33.1|Standard Error of the Mean|2.5|<|0.001|2-Sided|95.0|-38.04|-28.17||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647507|NCT01762761|3030102|Superiority or Other (legacy)||Odds Ratio (OR)|0.59||||0.306|2-Sided|95.0|0.21|1.64|||Mixed Models Analysis||||
1647037|NCT01763905|3029925|Superiority or Other||LS Mean Treatment Difference|-32.86|Standard Error of the Mean|2.62|<|0.001|2-Sided|95.0|-38.04|-27.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647038|NCT01763905|3029926|Superiority or Other||LS Mean Treatment Difference|-34.99|Standard Error of the Mean|2.33|<|0.001|2-Sided|95.0|-39.59|-30.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647039|NCT01763905|3029926|Superiority or Other||LS Mean Treatment Difference|-32.2|Standard Error of the Mean|2.39|<|0.001|2-Sided|95.0|-36.92|-27.49||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647040|NCT01763905|3029927|Superiority or Other||LS Mean Treatment Difference|-32.99|Standard Error of the Mean|2.12|<|0.001|2-Sided|95.0|-37.19|-28.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647041|NCT01763905|3029927|Superiority or Other||LS Mean Treatment Difference|-32.09|Standard Error of the Mean|2.63|<|0.001|2-Sided|95.0|-37.28|-26.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647042|NCT01763905|3029928|Superiority or Other||LS Mean Treatment Difference|-34.58|Standard Error of the Mean|2.05|<|0.001|2-Sided|95.0|-38.63|-30.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647043|NCT01763905|3029928|Superiority or Other||LS Mean Treatment Difference|-31.53|Standard Error of the Mean|2.43|<|0.001|2-Sided|95.0|-36.34|-26.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647044|NCT01763905|3029929|Superiority or Other||Treatment Difference|37.5|||<|0.001|2-Sided|95.0|25.5|47.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.|||
1647045|NCT01763905|3029929|Superiority or Other||Treatment Difference|48.0|||<|0.001|2-Sided|95.0|35.0|57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.|||
1647046|NCT01763905|3029930|Superiority or Other||Treatment Difference|42.0|||<|0.001|2-Sided|95.0|30.3|51.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.|||
1647047|NCT01763905|3029930|Superiority or Other||Treatment Difference|43.5|||<|0.001|2-Sided|95.0|30.9|53.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.|||
1647048|NCT01763905|3029931|Superiority or Other||LS Mean Treatment Difference|-68.8|Standard Error of the Mean|5.3|<|0.001|2-Sided|95.0|-79.2|-58.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647049|NCT01763905|3029931|Superiority or Other||LS Mean Treatment Difference|-69.7|Standard Error of the Mean|6.2|<|0.001|2-Sided|95.0|-82.0|-57.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647050|NCT01763905|3029932|Superiority or Other||LS Mean Treatment Difference|-70.6|Standard Error of the Mean|5.0|<|0.001|2-Sided|95.0|-80.5|-60.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647051|NCT01763905|3029932|Superiority or Other||LS Mean Treatment Difference|-66.3|Standard Error of the Mean|5.9|<|0.001|2-Sided|95.0|-77.9|-54.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.|||
1647052|NCT01763905|3029933|Superiority or Other||LS Mean Treatment Difference|-37.55|Standard Error of the Mean|2.33|<|0.001|2-Sided|95.0|-42.16|-32.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.|
1647070|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|6.75|Standard Error of the Mean|2.2|<|0.002|2-Sided|95.0|2.4|11.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647570|NCT01758432|3030442|Superiority||Least Squares Means (Difference)|182753.2|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647053|NCT01763905|3029933|Superiority or Other||LS Mean Treatment Difference|-38.06|Standard Error of the Mean|2.87|<|0.001|2-Sided|95.0|-43.73|-32.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.||The null hypothesis was that there is no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.|
1647054|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|9.06|Standard Error of the Mean|2.36|<|0.001|2-Sided|95.0|4.4|13.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647055|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|9.78|Standard Error of the Mean|2.9|<|0.001|2-Sided|95.0|4.05|15.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647056|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|4.84|Standard Error of the Mean|2.41|<|0.002|2-Sided|95.0|0.07|9.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647057|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|5.04|Standard Error of the Mean|2.29|<|0.013|2-Sided|95.0|0.52|9.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647058|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|7.35|Standard Error of the Mean|3.23|<|0.01|2-Sided|95.0|0.97|13.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647059|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|3.2|Standard Error of the Mean|2.3|<|0.001|2-Sided|95.0|-1.33|7.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647060|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|7.14|Standard Error of the Mean|2.46|<|0.003|2-Sided|95.0|2.29|11.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647061|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|8.47|Standard Error of the Mean|2.23|<|0.003|2-Sided|95.0|4.07|12.87||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647062|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|7.05|Standard Error of the Mean|2.45|<|0.001|2-Sided|95.0|2.22|11.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647063|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|4.07|Standard Error of the Mean|2.28|<|0.85|2-Sided|95.0|-0.42|8.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647064|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|8.28|Standard Error of the Mean|2.45|<|0.006|2-Sided|95.0|3.46|13.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647065|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|8.81|Standard Error of the Mean|2.14|<|0.001|2-Sided|95.0|4.58|13.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647066|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|7.87|Standard Error of the Mean|2.46|<|0.017|2-Sided|95.0|3.01|12.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647067|NCT01763866|3029934|Superiority or Other||LS Mean Treatment Difference|6.83|Standard Error of the Mean|2.11|<|0.034|2-Sided|95.0|2.66|10.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647068|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|8.85|Standard Error of the Mean|2.09|<|0.001|2-Sided|95.0|4.73|12.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647069|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|10.23|Standard Error of the Mean|2.58|<|0.001|2-Sided|95.0|5.13|15.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647805|NCT01753856|3030869|Superiority or Other||||||<|0.001||||||DL and SL, in EC.|Fisher Exact||||
1647071|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|5.46|Standard Error of the Mean|1.91|<|0.013|2-Sided|95.0|1.69|9.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647072|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|8.66|Standard Error of the Mean|3.11|<|0.01|2-Sided|95.0|2.51|14.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647073|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|5.36|Standard Error of the Mean|1.87|<|0.001|2-Sided|95.0|1.68|9.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647074|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|8.35|Standard Error of the Mean|2.28|<|0.003|2-Sided|95.0|3.86|12.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647075|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|7.57|Standard Error of the Mean|2.06|<|0.003|2-Sided|95.0|3.51|11.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647076|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|9.13|Standard Error of the Mean|2.26|<|0.001|2-Sided|95.0|4.68|13.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647077|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|3.95|Standard Error of the Mean|2.1|<|0.85|2-Sided|95.0|-0.19|8.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647078|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|8.57|Standard Error of the Mean|2.36|<|0.006|2-Sided|95.0|3.93|13.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647079|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|6.67|Standard Error of the Mean|1.86|<|0.001|2-Sided|95.0|3.0|10.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647080|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|8.11|Standard Error of the Mean|2.37|<|0.017|2-Sided|95.0|3.43|12.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647081|NCT01763866|3029935|Superiority or Other||LS Mean Treatment Difference|6.53|Standard Error of the Mean|1.84|<|0.034|2-Sided|95.0|2.91|10.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647082|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|-36.83|Standard Error of the Mean|6.14|<|0.001|2-Sided|95.0|-48.96|-24.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647083|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|-22.45|Standard Error of the Mean|5.39|<|0.001|2-Sided|95.0|-33.09|-11.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647084|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|-18.54|Standard Error of the Mean|5.31|<|0.001|2-Sided|95.0|-29.04|-8.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647085|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|-16.19|Standard Error of the Mean|5.7|<|0.005|2-Sided|95.0|-27.46|-4.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647086|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|-18.75|Standard Error of the Mean|6.5|<|0.007|2-Sided|95.0|-31.6|-5.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647087|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|-21.98|Standard Error of the Mean|6.2|<|0.001|2-Sided|95.0|-34.24|-9.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647508|NCT01762761|3030103|Superiority or Other (legacy)||Odds Ratio (OR)|0.28||||0.001|2-Sided|95.0|0.13|0.59|||Mixed Models Analysis||||
1647571|NCT01758432|3030442|Superiority||Least Squares Means (Difference)|105508.3|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647088|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|4.94|Standard Error of the Mean|6.18|<|0.62|2-Sided|95.0|-7.25|17.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647089|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|-1.78|Standard Error of the Mean|5.27|<|1|2-Sided|95.0|-12.16|8.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647090|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|-9.6|Standard Error of the Mean|6.13|<|0.027|2-Sided|95.0|-21.68|2.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647091|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|-16.42|Standard Error of the Mean|5.39|<|0.073|2-Sided|95.0|-27.05|-5.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647092|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|-15.19|Standard Error of the Mean|7.21|<|0.056|2-Sided|95.0|-29.4|-0.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647093|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|-1.54|Standard Error of the Mean|5.0|<|1|2-Sided|95.0|-11.41|8.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647094|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|-26.47|Standard Error of the Mean|7.22|<|0.005|2-Sided|95.0|-40.71|-12.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647095|NCT01763866|3029936|Superiority or Other||LS Mean Treatment Difference|-14.47|Standard Error of the Mean|4.92|<|0.088|2-Sided|95.0|-24.16|-4.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647096|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-32.87|Standard Error of the Mean|5.43|<|0.001|2-Sided|95.0|-43.6|-22.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647097|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-23.21|Standard Error of the Mean|4.95|<|0.001|2-Sided|95.0|-33.0|-13.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647098|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-23.18|Standard Error of the Mean|4.52|<|0.001|2-Sided|95.0|-32.11|-14.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647099|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-16.15|Standard Error of the Mean|4.61|<|0.005|2-Sided|95.0|-25.27|-7.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647100|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-19.79|Standard Error of the Mean|5.58|<|0.007|2-Sided|95.0|-30.81|-8.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647101|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-25.07|Standard Error of the Mean|4.85|<|0.001|2-Sided|95.0|-34.64|-15.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647102|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-0.25|Standard Error of the Mean|5.28|<|0.62|2-Sided|95.0|-10.66|10.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647103|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-0.44|Standard Error of the Mean|4.82|<|1|2-Sided|95.0|-9.94|9.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647104|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-14.69|Standard Error of the Mean|5.21|<|0.027|2-Sided|95.0|-24.97|-4.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647509|NCT01762761|3030104|Superiority or Other (legacy)||Odds Ratio (OR)|8.52|||<|0.001|2-Sided|95.0|3.84|18.94|||Regression, Logistic||||
1647510|NCT01762761|3030105|Superiority or Other (legacy)||Odds Ratio (OR)|23.8|||<|0.001|2-Sided|95.0|8.54|66.33|||Regression, Logistic||||
1647105|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-15.21|Standard Error of the Mean|4.91|<|0.073|2-Sided|95.0|-24.88|-5.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647106|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-13.54|Standard Error of the Mean|5.39|<|0.056|2-Sided|95.0|-24.17|-2.91||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647107|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-1.5|Standard Error of the Mean|4.45|<|1|2-Sided|95.0|-10.27|7.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647108|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-21.31|Standard Error of the Mean|5.41|<|0.005|2-Sided|95.0|-31.98|-10.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647109|NCT01763866|3029937|Superiority or Other||LS Mean Treatment Difference|-13.36|Standard Error of the Mean|4.38|<|0.088|2-Sided|95.0|-21.99|-4.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647110|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|-31.36|Standard Error of the Mean|6.45|<|0.001|2-Sided|95.0|-44.1|-18.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647111|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|-21.78|Standard Error of the Mean|5.62|<|0.001|2-Sided|95.0|-32.88|-10.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647112|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|-20.51|Standard Error of the Mean|5.33|<|0.001|2-Sided|95.0|-31.04|-9.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647113|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|-16.55|Standard Error of the Mean|5.71|<|0.002|2-Sided|95.0|-27.84|-5.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647114|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|-19.83|Standard Error of the Mean|6.52|<|0.007|2-Sided|95.0|-32.71|-6.96||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647115|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|-18.03|Standard Error of the Mean|7.08|<|0.001|2-Sided|95.0|-32.03|-4.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647116|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|2.02|Standard Error of the Mean|6.43|<|0.63|2-Sided|95.0|-10.66|14.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647117|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|-2.67|Standard Error of the Mean|5.27|<|1|2-Sided|95.0|-13.05|7.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647118|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|-9.31|Standard Error of the Mean|6.39|<|0.027|2-Sided|95.0|-21.92|3.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647119|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|-16.72|Standard Error of the Mean|5.39|<|0.073|2-Sided|95.0|-27.34|-6.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647120|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|-18.13|Standard Error of the Mean|7.18|<|0.053|2-Sided|95.0|-32.28|-3.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647121|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|-3.37|Standard Error of the Mean|6.49|<|1|2-Sided|95.0|-16.16|9.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647511|NCT01762761|3030106|Superiority or Other (legacy)||Odds Ratio (OR)|26.08|||<|0.001|2-Sided|95.0|7.29|93.26|||Regression, Logistic||||
1647512|NCT01761175|3030179|Superiority or Other|||||||0.34|||||||Wilcoxon (Mann-Whitney)||||
1647122|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|-27.6|Standard Error of the Mean|7.23|<|0.003|2-Sided|95.0|-41.86|-13.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647123|NCT01763866|3029938|Superiority or Other||LS Mean Treatment Difference|-12.06|Standard Error of the Mean|6.41|<|0.2|2-Sided|95.0|-24.69|0.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647124|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-29.71|Standard Error of the Mean|5.64|<|0.001|2-Sided|95.0|-40.84|-18.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647125|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-20.97|Standard Error of the Mean|5.78|<|0.001|2-Sided|95.0|-32.38|-9.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647126|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-26.18|Standard Error of the Mean|4.85|<|0.001|2-Sided|95.0|-35.76|-16.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647127|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-17.59|Standard Error of the Mean|4.62|<|0.002|2-Sided|95.0|-26.71|-8.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647128|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-19.52|Standard Error of the Mean|5.69|<|0.007|2-Sided|95.0|-30.76|-8.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647129|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-22.72|Standard Error of the Mean|5.15|<|0.001|2-Sided|95.0|-32.9|-12.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647130|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-1.51|Standard Error of the Mean|5.38|<|0.63|2-Sided|95.0|-12.12|9.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647131|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-1.17|Standard Error of the Mean|4.8|<|1|2-Sided|95.0|-10.63|8.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647132|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-14.41|Standard Error of the Mean|5.32|<|0.027|2-Sided|95.0|-24.9|-3.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647133|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-15.43|Standard Error of the Mean|4.89|<|0.073|2-Sided|95.0|-25.06|-5.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647134|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-14.95|Standard Error of the Mean|5.33|<|0.053|2-Sided|95.0|-25.46|-4.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647135|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-2.45|Standard Error of the Mean|4.89|<|1|2-Sided|95.0|-12.09|7.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647136|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-22.55|Standard Error of the Mean|5.36|<|0.003|2-Sided|95.0|-33.13|-11.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647137|NCT01763866|3029939|Superiority or Other||LS Mean Treatment Difference|-12.1|Standard Error of the Mean|4.83|<|0.2|2-Sided|95.0|-21.63|-2.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647138|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-28.17|Standard Error of the Mean|4.36|<|0.001|2-Sided|95.0|-36.79|-19.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647513|NCT01761175|3030180|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1647514|NCT01761175|3030181|Superiority or Other|||||||0.02|||||||Chi-squared||||
1647515|NCT01761175|3030182|Superiority or Other||||||<|0.01|||||||Log Rank||||
1647139|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-31.25|Standard Error of the Mean|3.62|<|0.001|2-Sided|95.0|-38.4|-24.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647140|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-32.17|Standard Error of the Mean|5.28|<|0.001|2-Sided|95.0|-42.61|-21.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647141|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-36.48|Standard Error of the Mean|3.78|<|0.001|2-Sided|95.0|-43.95|-29.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647142|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-25.34|Standard Error of the Mean|4.48|<|0.001|2-Sided|95.0|-34.19|-16.49||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647143|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-36.5|Standard Error of the Mean|4.15|<|0.001|2-Sided|95.0|-44.69|-28.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647144|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-34.88|Standard Error of the Mean|4.38|<|0.001|2-Sided|95.0|-43.52|-26.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647145|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-32.62|Standard Error of the Mean|3.98|<|0.001|2-Sided|95.0|-40.46|-24.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647146|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-28.1|Standard Error of the Mean|4.32|<|0.001|2-Sided|95.0|-36.62|-19.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647147|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-22.38|Standard Error of the Mean|4.07|<|0.001|2-Sided|95.0|-30.39|-14.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647148|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-27.44|Standard Error of the Mean|4.12|<|0.001|2-Sided|95.0|-35.56|-19.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647149|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-29.16|Standard Error of the Mean|3.91|<|0.001|2-Sided|95.0|-36.87|-21.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647150|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-19.82|Standard Error of the Mean|4.11|<|0.001|2-Sided|95.0|-27.92|-11.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647151|NCT01763866|3029940|Superiority or Other||LS Mean Treatment Difference|-33.2|Standard Error of the Mean|3.86|<|0.001|2-Sided|95.0|-40.81|-25.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647152|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-27.16|Standard Error of the Mean|3.76|<|0.001|2-Sided|95.0|-34.59|-19.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647153|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-28.07|Standard Error of the Mean|3.46|<|0.001|2-Sided|95.0|-34.91|-21.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647154|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-32.19|Standard Error of the Mean|4.36|<|0.001|2-Sided|95.0|-40.8|-23.58||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647155|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-33.56|Standard Error of the Mean|3.64|<|0.001|2-Sided|95.0|-40.74|-26.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647516|NCT01761175|3030183|Superiority or Other||||||<|0.01|||||||Log Rank||||
1647517|NCT01761175|3030184|Superiority or Other||||||<|0.01|||||||Chi-squared||||
1647518|NCT01761175|3030185|Superiority or Other||||||<|0.01|||||||Chi-squared||||
1647156|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-26.81|Standard Error of the Mean|4.33|<|0.001|2-Sided|95.0|-35.36|-18.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647157|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-35.66|Standard Error of the Mean|3.69|<|0.001|2-Sided|95.0|-42.94|-28.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647158|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-37.42|Standard Error of the Mean|4.15|<|0.001|2-Sided|95.0|-45.61|-29.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647159|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-32.02|Standard Error of the Mean|3.6|<|0.001|2-Sided|95.0|-39.11|-24.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647160|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-28.96|Standard Error of the Mean|4.08|<|0.001|2-Sided|95.0|-37.01|-20.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647161|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-20.52|Standard Error of the Mean|3.65|<|0.001|2-Sided|95.0|-27.71|-13.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647162|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-29.49|Standard Error of the Mean|3.99|<|0.001|2-Sided|95.0|-37.36|-21.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647163|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-27.45|Standard Error of the Mean|3.59|<|0.001|2-Sided|95.0|-34.53|-20.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647164|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-21.86|Standard Error of the Mean|3.98|<|0.001|2-Sided|95.0|-29.7|-14.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647165|NCT01763866|3029941|Superiority or Other||LS Mean Treatment Difference|-32.08|Standard Error of the Mean|3.54|<|0.001|2-Sided|95.0|-39.06|-25.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647166|NCT01763866|3029942|Superiority or Other||Treatment Difference|78.4|||<|0.001|2-Sided|95.0|64.9|85.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647167|NCT01763866|3029942|Superiority or Other||Treatment Difference|92.5|||<|0.001|2-Sided|95.0|82.3|95.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647168|NCT01763866|3029942|Superiority or Other||Treatment Difference|64.3|||<|0.001|2-Sided|95.0|49.1|75.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647169|NCT01763866|3029942|Superiority or Other||Treatment Difference|52.7|||<|0.001|2-Sided|95.0|37.6|65.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647170|NCT01763866|3029942|Superiority or Other||Treatment Difference|81.1|||<|0.001|2-Sided|95.0|68.8|87.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647171|NCT01763866|3029942|Superiority or Other||Treatment Difference|77.3|||<|0.001|2-Sided|95.0|63.9|84.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647172|NCT01763866|3029942|Superiority or Other||Treatment Difference|35.2|||<|0.001|2-Sided|95.0|20.7|49.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647173|NCT01763866|3029942|Superiority or Other||Treatment Difference|41.1|||<|0.001|2-Sided|95.0|26.4|55.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647806|NCT01753856|3030869|Superiority or Other||||||<|0.494||||||No Label, in CC.|Fisher Exact||||
1647174|NCT01763866|3029942|Superiority or Other||Treatment Difference|81.2|||<|0.001|2-Sided|95.0|67.9|88.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)|||
1647175|NCT01763866|3029942|Superiority or Other||Treatment Difference|80.1|||<|0.001|2-Sided|95.0|65.8|87.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647176|NCT01763866|3029942|Superiority or Other||Treatment Difference|64.9|||<|0.001|2-Sided|95.0|49.8|75.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)|||
1647177|NCT01763866|3029942|Superiority or Other||Treatment Difference|63.0|||<|0.001|2-Sided|95.0|47.3|73.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647178|NCT01763866|3029942|Superiority or Other||Treatment Difference|78.3|||<|0.001|2-Sided|95.0|65.2|85.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647179|NCT01763866|3029942|Superiority or Other||Treatment Difference|83.5|||<|0.001|2-Sided|95.0|71.9|89.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)|||
1647180|NCT01763866|3029943|Superiority or Other||Treatment Difference|84.6|||<|0.001|2-Sided|95.0|72.8|90.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647181|NCT01763866|3029943|Superiority or Other||Treatment Difference|91.7|||<|0.001|2-Sided|95.0|81.6|95.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647182|NCT01763866|3029943|Superiority or Other||Treatment Difference|65.7|||<|0.001|2-Sided|95.0|51.0|76.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647183|NCT01763866|3029943|Superiority or Other||Treatment Difference|54.6|||<|0.001|2-Sided|95.0|39.8|66.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647184|NCT01763866|3029943|Superiority or Other||Treatment Difference|84.6|||<|0.001|2-Sided|95.0|73.1|90.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647185|NCT01763866|3029943|Superiority or Other||Treatment Difference|81.7|||<|0.001|2-Sided|95.0|69.5|88.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647186|NCT01763866|3029943|Superiority or Other||Treatment Difference|30.3|||<|0.001|2-Sided|95.0|16.7|44.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647187|NCT01763866|3029943|Superiority or Other||Treatment Difference|43.5|||<|0.001|2-Sided|95.0|29.5|56.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647188|NCT01763866|3029943|Superiority or Other||Treatment Difference|83.3|||<|0.001|2-Sided|95.0|70.7|89.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)|||
1647189|NCT01763866|3029943|Superiority or Other||Treatment Difference|80.7|||<|0.001|2-Sided|95.0|67.3|88.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647190|NCT01763866|3029943|Superiority or Other||Treatment Difference|69.2|||<|0.001|2-Sided|95.0|54.8|78.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)|||
1647191|NCT01763866|3029943|Superiority or Other||Treatment Difference|68.1|||<|0.001|2-Sided|95.0|53.1|78.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647192|NCT01763866|3029943|Superiority or Other||Treatment Difference|80.3|||<|0.001|2-Sided|95.0|67.9|86.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).|||
1647193|NCT01763866|3029943|Superiority or Other||Treatment Difference|82.4|||<|0.001|2-Sided|95.0|70.2|88.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)|||
1647194|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-52.04|Standard Error of the Mean|3.07|<|0.001|2-Sided|95.0|-58.1|-45.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647195|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-57.73|Standard Error of the Mean|2.57|<|0.001|2-Sided|95.0|-62.82|-52.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647196|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-48.81|Standard Error of the Mean|4.25|<|0.001|2-Sided|95.0|-57.21|-40.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647197|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-49.17|Standard Error of the Mean|3.36|<|0.001|2-Sided|95.0|-55.8|-42.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647198|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-56.13|Standard Error of the Mean|2.76|<|0.001|2-Sided|95.0|-61.58|-50.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647199|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-54.41|Standard Error of the Mean|2.83|<|0.001|2-Sided|95.0|-59.99|-48.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647200|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-38.57|Standard Error of the Mean|3.9|<|0.001|2-Sided|95.0|-46.26|-30.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647201|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-39.9|Standard Error of the Mean|3.87|<|0.001|2-Sided|95.0|-47.53|-32.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647202|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-57.26|Standard Error of the Mean|3.88|<|0.001|2-Sided|95.0|-64.91|-49.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647203|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-57.77|Standard Error of the Mean|3.95|<|0.001|2-Sided|95.0|-65.55|-49.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647204|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-37.32|Standard Error of the Mean|2.94|<|0.001|2-Sided|95.0|-43.12|-31.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647205|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-39.66|Standard Error of the Mean|2.75|<|0.001|2-Sided|95.0|-45.09|-34.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647206|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-48.44|Standard Error of the Mean|2.94|<|0.001|2-Sided|95.0|-54.23|-42.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647207|NCT01763866|3029944|Superiority or Other||LS Mean Treatment Difference|-60.29|Standard Error of the Mean|2.71|<|0.001|2-Sided|95.0|-65.65|-54.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647208|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-56.06|Standard Error of the Mean|2.93|<|0.001|2-Sided|95.0|-61.85|-50.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647209|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-57.75|Standard Error of the Mean|2.41|<|0.001|2-Sided|95.0|-62.51|-52.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647367|NCT01763827|3029957|Superiority or Other||Median Treatment Difference|4.81||||0.013|2-Sided|95.0|0.85|8.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647210|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-56.78|Standard Error of the Mean|3.61|<|0.001|2-Sided|95.0|-63.91|-49.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647211|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-50.63|Standard Error of the Mean|3.13|<|0.001|2-Sided|95.0|-56.82|-44.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647212|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-59.24|Standard Error of the Mean|2.49|<|0.001|2-Sided|95.0|-64.16|-54.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647213|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-55.29|Standard Error of the Mean|2.78|<|0.001|2-Sided|95.0|-60.79|-49.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647214|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-43.29|Standard Error of the Mean|3.44|<|0.001|2-Sided|95.0|-50.07|-36.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647215|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-37.26|Standard Error of the Mean|3.66|<|0.001|2-Sided|95.0|-44.48|-30.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647216|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-61.99|Standard Error of the Mean|3.39|<|0.001|2-Sided|95.0|-68.68|-55.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647217|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-56.9|Standard Error of the Mean|3.71|<|0.001|2-Sided|95.0|-64.22|-49.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647218|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-41.86|Standard Error of the Mean|2.78|<|0.001|2-Sided|95.0|-47.34|-36.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647219|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-37.79|Standard Error of the Mean|2.54|<|0.001|2-Sided|95.0|-42.8|-32.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647220|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-54.11|Standard Error of the Mean|2.77|<|0.001|2-Sided|95.0|-59.57|-48.64||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647221|NCT01763866|3029945|Superiority or Other||LS Mean Treatment Difference|-59.97|Standard Error of the Mean|2.51|<|0.001|2-Sided|95.0|-64.91|-55.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647222|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-44.6|Standard Error of the Mean|3.07|<|0.001|2-Sided|95.0|-50.67|-38.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647223|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-47.04|Standard Error of the Mean|2.43|<|0.001|2-Sided|95.0|-51.83|-42.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647224|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-34.99|Standard Error of the Mean|3.41|<|0.001|2-Sided|95.0|-41.72|-28.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647225|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-41.13|Standard Error of the Mean|2.79|<|0.001|2-Sided|95.0|-46.65|-35.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647226|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-45.33|Standard Error of the Mean|2.89|<|0.001|2-Sided|95.0|-51.04|-39.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647519|NCT01761084|3030191|Superiority||Mean Difference (Final Values)|0.15||||0.461|2-Sided|95.0|-0.25|0.55|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in weight|
1647227|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-43.25|Standard Error of the Mean|2.79|<|0.001|2-Sided|95.0|-48.77|-37.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647228|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-25.19|Standard Error of the Mean|3.35|<|0.001|2-Sided|95.0|-31.79|-18.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647229|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-30.26|Standard Error of the Mean|3.26|<|0.001|2-Sided|95.0|-36.68|-23.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647230|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-42.43|Standard Error of the Mean|3.34|<|0.001|2-Sided|95.0|-49.01|-35.85||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647231|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-45.1|Standard Error of the Mean|3.33|<|0.001|2-Sided|95.0|-51.66|-38.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647232|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-30.22|Standard Error of the Mean|2.8|<|0.001|2-Sided|95.0|-35.74|-24.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647233|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-28.6|Standard Error of the Mean|2.51|<|0.001|2-Sided|95.0|-33.56|-23.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647234|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-42.86|Standard Error of the Mean|2.82|<|0.001|2-Sided|95.0|-48.43|-37.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647235|NCT01763866|3029946|Superiority or Other||LS Mean Treatment Difference|-46.83|Standard Error of the Mean|2.48|<|0.001|2-Sided|95.0|-51.73|-41.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647236|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-48.62|Standard Error of the Mean|2.86|<|0.001|2-Sided|95.0|-54.27|-42.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647237|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-47.05|Standard Error of the Mean|2.38|<|0.001|2-Sided|95.0|-51.76|-42.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647238|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-40.33|Standard Error of the Mean|2.87|<|0.001|2-Sided|95.0|-46.0|-34.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647239|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-40.59|Standard Error of the Mean|2.43|<|0.001|2-Sided|95.0|-45.38|-35.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647240|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-47.01|Standard Error of the Mean|2.75|<|0.001|2-Sided|95.0|-52.46|-41.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647241|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-44.73|Standard Error of the Mean|2.41|<|0.001|2-Sided|95.0|-49.5|-39.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647242|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-28.18|Standard Error of the Mean|2.88|<|0.001|2-Sided|95.0|-33.86|-22.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647243|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-28.3|Standard Error of the Mean|3.09|<|0.001|2-Sided|95.0|-34.39|-22.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647520|NCT01761084|3030193|Superiority||Mean Difference (Final Values)|8.1|Standard Error of the Mean|15.3||0.6|2-Sided|95.0|-23.3|39.5|||t-test, 1 sided|||Month 12|
1647807|NCT01753856|3030869|Superiority or Other||||||<|0.002||||||SL Only, in CC.|Fisher Exact||||
1647244|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-46.85|Standard Error of the Mean|2.86|<|0.001|2-Sided|95.0|-52.48|-41.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647245|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-44.48|Standard Error of the Mean|3.15|<|0.001|2-Sided|95.0|-50.69|-38.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647246|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-31.59|Standard Error of the Mean|2.55|<|0.001|2-Sided|95.0|-36.61|-26.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647247|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-26.06|Standard Error of the Mean|2.19|<|0.001|2-Sided|95.0|-30.36|-21.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647248|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-44.69|Standard Error of the Mean|2.57|<|0.001|2-Sided|95.0|-49.75|-39.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647249|NCT01763866|3029947|Superiority or Other||LS Mean Treatment Difference|-46.41|Standard Error of the Mean|2.16|<|0.001|2-Sided|95.0|-50.66|-42.15||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647250|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-52.73|Standard Error of the Mean|3.38|<|0.001|2-Sided|95.0|-59.4|-46.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647251|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-56.3|Standard Error of the Mean|2.61|<|0.001|2-Sided|95.0|-61.47|-51.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647252|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-46.95|Standard Error of the Mean|3.78|<|0.001|2-Sided|95.0|-54.43|-39.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647253|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-50.52|Standard Error of the Mean|3.31|<|0.001|2-Sided|95.0|-57.06|-43.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647254|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-53.21|Standard Error of the Mean|2.57|<|0.001|2-Sided|95.0|-58.29|-48.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647255|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-56.5|Standard Error of the Mean|2.58|<|0.001|2-Sided|95.0|-61.6|-51.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647256|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-34.31|Standard Error of the Mean|3.98|<|0.001|2-Sided|95.0|-42.15|-26.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647257|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-37.45|Standard Error of the Mean|3.91|<|0.001|2-Sided|95.0|-45.17|-29.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647258|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-53.01|Standard Error of the Mean|3.93|<|0.001|2-Sided|95.0|-60.77|-45.25||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647259|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-61.4|Standard Error of the Mean|3.99|<|0.001|2-Sided|95.0|-69.27|-53.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647260|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-36.21|Standard Error of the Mean|2.97|<|0.001|2-Sided|95.0|-42.06|-30.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647521|NCT01761084|3030193|Superiority||Mean Difference (Final Values)|-5.2|Standard Error of the Mean|13.9||0.712|2-Sided|95.0|-33.6|23.2|||t-test, 2 sided|||Baseline|
1647808|NCT01753856|3030869|Superiority or Other||||||<|0.001||||||DL and SL, in CC.|Fisher Exact||||
1647261|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-34.92|Standard Error of the Mean|2.69|<|0.001|2-Sided|95.0|-40.23|-29.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647262|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-47.36|Standard Error of the Mean|2.96|<|0.001|2-Sided|95.0|-53.2|-41.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647263|NCT01763866|3029948|Superiority or Other||LS Mean Treatment Difference|-58.79|Standard Error of the Mean|2.66|<|0.001|2-Sided|95.0|-64.03|-53.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647264|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-56.87|Standard Error of the Mean|3.24|<|0.001|2-Sided|95.0|-63.27|-50.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647265|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-55.34|Standard Error of the Mean|2.33|<|0.001|2-Sided|95.0|-59.94|-50.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647266|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-54.94|Standard Error of the Mean|3.12|<|0.001|2-Sided|95.0|-61.11|-48.76||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647267|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-50.78|Standard Error of the Mean|3.01|<|0.001|2-Sided|95.0|-56.72|-44.83||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647268|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-56.14|Standard Error of the Mean|2.29|<|0.001|2-Sided|95.0|-60.66|-51.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647269|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-54.86|Standard Error of the Mean|2.43|<|0.001|2-Sided|95.0|-59.66|-50.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647270|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-39.64|Standard Error of the Mean|3.52|<|0.001|2-Sided|95.0|-46.57|-32.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647271|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-34.92|Standard Error of the Mean|3.64|<|0.001|2-Sided|95.0|-42.09|-27.75||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647272|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-58.74|Standard Error of the Mean|3.46|<|0.001|2-Sided|95.0|-65.56|-51.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647273|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-59.34|Standard Error of the Mean|3.69|<|0.001|2-Sided|95.0|-66.61|-52.07||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647274|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-40.01|Standard Error of the Mean|2.67|<|0.001|2-Sided|95.0|-45.27|-34.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647275|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-33.66|Standard Error of the Mean|2.37|<|0.001|2-Sided|95.0|-38.33|-28.98||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647276|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-52.25|Standard Error of the Mean|2.66|<|0.001|2-Sided|95.0|-57.49|-47.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647277|NCT01763866|3029949|Superiority or Other||LS Mean Treatment Difference|-58.49|Standard Error of the Mean|2.34|<|0.001|2-Sided|95.0|-63.1|-53.89||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647522|NCT01761084|3030194|Superiority||Mean Difference (Net)|-0.055||||0.9|2-Sided|95.0|-0.917|0.807|||t-test, 2 sided|||Month 12 scores.|
1647572|NCT01758432|3030442|Superiority||Least Squares Means (Difference)|85559.49|||<|0.0004|2-Sided|95.0|||||ANCOVA||||
1647278|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-56.63|Standard Error of the Mean|4.06|<|0.001|2-Sided|95.0|-64.63|-48.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647279|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-60.91|Standard Error of the Mean|2.87|<|0.001|2-Sided|95.0|-66.57|-55.24||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647280|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-49.76|Standard Error of the Mean|4.3|<|0.001|2-Sided|95.0|-58.26|-41.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647281|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-59.58|Standard Error of the Mean|3.73|<|0.001|2-Sided|95.0|-66.95|-52.21||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647282|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-57.42|Standard Error of the Mean|2.96|<|0.001|2-Sided|95.0|-63.27|-51.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647283|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-59.96|Standard Error of the Mean|2.95|<|0.001|2-Sided|95.0|-65.78|-54.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647284|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-32.79|Standard Error of the Mean|4.32|<|0.001|2-Sided|95.0|-41.3|-24.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647285|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-40.51|Standard Error of the Mean|4.59|<|0.001|2-Sided|95.0|-49.55|-31.47||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647286|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-60.01|Standard Error of the Mean|4.3|<|0.001|2-Sided|95.0|-68.49|-51.52||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647287|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-66.64|Standard Error of the Mean|4.69|<|0.001|2-Sided|95.0|-75.88|-57.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647288|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-37.72|Standard Error of the Mean|3.26|<|0.001|2-Sided|95.0|-44.15|-31.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647289|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-35.11|Standard Error of the Mean|2.88|<|0.001|2-Sided|95.0|-40.79|-29.44||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647290|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-54.93|Standard Error of the Mean|3.28|<|0.001|2-Sided|95.0|-61.4|-48.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647291|NCT01763866|3029950|Superiority or Other||LS Mean Treatment Difference|-61.64|Standard Error of the Mean|2.84|<|0.001|2-Sided|95.0|-67.25|-56.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647292|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-62.82|Standard Error of the Mean|3.75|<|0.001|2-Sided|95.0|-70.22|-55.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647293|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-60.06|Standard Error of the Mean|2.59|<|0.001|2-Sided|95.0|-65.18|-54.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647294|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-57.31|Standard Error of the Mean|3.53|<|0.001|2-Sided|95.0|-64.29|-50.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647523|NCT01761084|3030195|Superiority||Mean Difference (Final Values)|0.13||||0.536|2-Sided|95.0|-0.28|0.53|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in height|
1647295|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-58.27|Standard Error of the Mean|3.2|<|0.001|2-Sided|95.0|-64.6|-51.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647296|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-59.2|Standard Error of the Mean|2.83|<|0.001|2-Sided|95.0|-64.8|-53.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647297|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-59.61|Standard Error of the Mean|2.6|<|0.001|2-Sided|95.0|-64.73|-54.48||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647298|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-37.52|Standard Error of the Mean|3.87|<|0.001|2-Sided|95.0|-45.15|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647299|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-38.25|Standard Error of the Mean|4.28|<|0.001|2-Sided|95.0|-46.68|-29.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647300|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-64.76|Standard Error of the Mean|3.84|<|0.001|2-Sided|95.0|-72.32|-57.19||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647301|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-65.17|Standard Error of the Mean|4.37|<|0.001|2-Sided|95.0|-73.78|-56.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647302|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-39.53|Standard Error of the Mean|2.95|<|0.001|2-Sided|95.0|-45.34|-33.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647303|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-32.77|Standard Error of the Mean|2.57|<|0.001|2-Sided|95.0|-37.84|-27.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647304|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-57.37|Standard Error of the Mean|2.97|<|0.001|2-Sided|95.0|-63.23|-51.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647305|NCT01763866|3029951|Superiority or Other||LS Mean Treatment Difference|-60.28|Standard Error of the Mean|2.54|<|0.001|2-Sided|95.0|-65.29|-55.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647306|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-71.9|Standard Error of the Mean|6.0|<|0.001|2-Sided|95.0|-83.8|-60.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647307|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-79.0|Standard Error of the Mean|4.3|<|0.001|2-Sided|95.0|-87.5|-70.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647308|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-44.6|Standard Error of the Mean|5.7|<|0.001|2-Sided|95.0|-55.9|-33.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647309|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-57.2|Standard Error of the Mean|4.0|<|0.001|2-Sided|95.0|-65.1|-49.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647310|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-75.8|Standard Error of the Mean|5.3|<|0.001|2-Sided|95.0|-86.3|-65.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647311|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-77.1|Standard Error of the Mean|4.6|<|0.001|2-Sided|95.0|-86.2|-67.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647524|NCT01761084|3030198|Superiority||Incident Rate Ratio|0.97|||||2-Sided|95.0|0.58|1.63||||||Negative Binomial Regression.|
1647573|NCT01758432|3030443|Superiority||Least Squares Means (Difference)|-135.91|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647312|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-35.3|Standard Error of the Mean|5.0|<|0.001|2-Sided|95.0|-45.2|-25.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647313|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-49.0|Standard Error of the Mean|6.3|<|0.001|2-Sided|95.0|-61.5|-36.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647314|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-61.8|Standard Error of the Mean|5.0|<|0.001|2-Sided|95.0|-71.6|-52.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647315|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-71.7|Standard Error of the Mean|6.4|<|0.001|2-Sided|95.0|-84.4|-59.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647316|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-51.7|Standard Error of the Mean|5.5|<|0.001|2-Sided|95.0|-62.6|-40.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647317|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-46.8|Standard Error of the Mean|4.9|<|0.001|2-Sided|95.0|-56.6|-37.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647318|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-75.8|Standard Error of the Mean|5.5|<|0.001|2-Sided|95.0|-86.8|-64.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647319|NCT01763866|3029952|Superiority or Other||LS Mean Treatment Difference|-85.5|Standard Error of the Mean|4.9|<|0.001|2-Sided|95.0|-95.2|-75.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647320|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-80.1|Standard Error of the Mean|5.8|<|0.001|2-Sided|95.0|-91.7|-68.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit|||
1647321|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-78.1|Standard Error of the Mean|4.1|<|0.001|2-Sided|95.0|-86.2|-70.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647322|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-50.6|Standard Error of the Mean|5.1|<|0.001|2-Sided|95.0|-60.6|-40.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647323|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-55.8|Standard Error of the Mean|3.7|<|0.001|2-Sided|95.0|-63.1|-48.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647324|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-77.9|Standard Error of the Mean|5.1|<|0.001|2-Sided|95.0|-88.0|-67.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647325|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-75.4|Standard Error of the Mean|4.3|<|0.001|2-Sided|95.0|-83.9|-67.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647326|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-38.8|Standard Error of the Mean|4.5|<|0.001|2-Sided|95.0|-47.8|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647327|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-45.8|Standard Error of the Mean|6.0|<|0.001|2-Sided|95.0|-57.7|-33.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647328|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-65.6|Standard Error of the Mean|4.5|<|0.001|2-Sided|95.0|-74.5|-56.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647368|NCT01763827|3029957|Superiority or Other||Median Treatment Difference|8.48|||<|0.001|2-Sided|95.0|5.53|11.43||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647329|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-69.9|Standard Error of the Mean|6.1|<|0.001|2-Sided|95.0|-81.9|-57.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647330|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-55.0|Standard Error of the Mean|5.3|<|0.001|2-Sided|95.0|-65.4|-44.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647331|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-44.4|Standard Error of the Mean|4.4|<|0.001|2-Sided|95.0|-53.4|-35.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647332|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-79.7|Standard Error of the Mean|5.3|<|0.001|2-Sided|95.0|-90.2|-69.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647333|NCT01763866|3029953|Superiority or Other||LS Mean Treatment Difference|-83.6|Standard Error of the Mean|4.5|<|0.001|2-Sided|95.0|-92.6|-74.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.|||
1647334|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-68.45|Standard Error of the Mean|4.17|<|0.001|2-Sided|95.0|-76.68|-60.22||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647335|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-69.43|Standard Error of the Mean|2.74|<|0.001|2-Sided|95.0|-74.86|-64.01||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647336|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-62.91|Standard Error of the Mean|4.27|<|0.001|2-Sided|95.0|-71.37|-54.46||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647337|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-65.66|Standard Error of the Mean|3.81|<|0.001|2-Sided|95.0|-73.19|-58.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647338|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-66.58|Standard Error of the Mean|3.05|<|0.001|2-Sided|95.0|-72.6|-60.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647339|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-66.88|Standard Error of the Mean|2.93|<|0.001|2-Sided|95.0|-72.67|-61.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647340|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-43.81|Standard Error of the Mean|4.19|<|0.001|2-Sided|95.0|-52.06|-35.55||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1647341|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-44.95|Standard Error of the Mean|4.75|<|0.001|2-Sided|95.0|-54.32|-35.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1647567|NCT01758432|3030442|Superiority||Least Squares Means (Difference)|169709.9|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647342|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-74.81|Standard Error of the Mean|4.15|<|0.001|2-Sided|95.0|-83.0|-66.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647343|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-74.92|Standard Error of the Mean|4.85|<|0.001|2-Sided|95.0|-84.49|-65.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647344|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-43.49|Standard Error of the Mean|3.15|<|0.001|2-Sided|95.0|-49.7|-37.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1647345|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-37.53|Standard Error of the Mean|2.79|<|0.001|2-Sided|95.0|-43.03|-32.03||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1647346|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-62.82|Standard Error of the Mean|3.17|<|0.001|2-Sided|95.0|-69.06|-56.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647347|NCT01763866|3029954|Superiority or Other||LS Mean Treatment Difference|-69.95|Standard Error of the Mean|2.76|<|0.001|2-Sided|95.0|-75.38|-64.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647348|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-60.41|Standard Error of the Mean|4.41|<|0.001|2-Sided|95.0|-69.11|-51.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647349|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-70.56|Standard Error of the Mean|3.12|<|0.001|2-Sided|95.0|-76.72|-64.41||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647350|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-54.98|Standard Error of the Mean|5.23|<|0.001|2-Sided|95.0|-65.31|-44.65||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647351|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-68.31|Standard Error of the Mean|4.42|<|0.001|2-Sided|95.0|-77.04|-59.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647352|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-64.49|Standard Error of the Mean|3.21|<|0.001|2-Sided|95.0|-70.84|-58.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647369|NCT01763827|3029957|Superiority or Other||Median Treatment Difference|5.53|||<|0.007|2-Sided|95.0|2.23|8.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647568|NCT01758432|3030442|Superiority||Least Squares Means (Difference)|178055.0|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647353|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-68.21|Standard Error of the Mean|3.3|<|0.001|2-Sided|95.0|-74.72|-61.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647354|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-38.88|Standard Error of the Mean|4.73|<|0.001|2-Sided|95.0|-48.21|-29.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1647355|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-47.2|Standard Error of the Mean|5.24|<|0.001|2-Sided|95.0|-57.54|-36.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1647356|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-70.51|Standard Error of the Mean|4.72|<|0.001|2-Sided|95.0|-79.81|-61.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647357|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-76.29|Standard Error of the Mean|5.36|<|0.001|2-Sided|95.0|-86.87|-65.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647358|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-41.1|Standard Error of the Mean|3.41|<|0.001|2-Sided|95.0|-47.83|-34.37||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1647359|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-39.6|Standard Error of the Mean|3.15|<|0.001|2-Sided|95.0|-45.81|-33.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1647360|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-59.16|Standard Error of the Mean|3.44|<|0.001|2-Sided|95.0|-65.94|-52.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647361|NCT01763866|3029955|Superiority or Other||LS Mean Treatment Difference|-71.42|Standard Error of the Mean|3.11|<|0.001|2-Sided|95.0|-77.55|-65.29||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.||The null hypothesis was that there was no difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647362|NCT01763827|3029956|Superiority or Other||Median Treatment Difference|5.53||||0.044|2-Sided|95.0|2.22|8.84||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647363|NCT01763827|3029956|Superiority or Other||Median Treatment Difference|7.56||||0.013|2-Sided|95.0|3.11|12.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647364|NCT01763827|3029956|Superiority or Other||Median Treatment Difference|9.33|||<|0.001|2-Sided|95.0|5.32|13.34||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647365|NCT01763827|3029956|Superiority or Other||Median Treatment Difference|5.91|||<|0.007|2-Sided|95.0|1.67|10.16||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647366|NCT01763827|3029957|Superiority or Other||Median Treatment Difference|3.81||||0.044|2-Sided|95.0|-0.77|8.39||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline visit|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647489|NCT01763203|3030032|Superiority|||||||0.1|||||||Mixed Models Analysis||||
1647490|NCT01763203|3030033|Superiority|||||||0.86|||||||Mixed Models Analysis||||
1647370|NCT01763827|3029958|Superiority or Other||Median Treatment Difference|-12.72||||0.044|2-Sided|95.0|-20.89|-4.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647371|NCT01763827|3029958|Superiority or Other||Median Treatment Difference|-8.58||||0.082|2-Sided|95.0|-18.1|0.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647372|NCT01763827|3029958|Superiority or Other||Median Treatment Difference|-16.33|||<|0.001|2-Sided|95.0|-25.64|-7.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647373|NCT01763827|3029958|Superiority or Other||Median Treatment Difference|-7.94|||<|0.72|2-Sided|95.0|-18.81|2.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647374|NCT01763827|3029959|Superiority or Other||Median Treatment Difference|-12.84||||0.044|2-Sided|95.0|-22.14|-3.54||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baselie value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647375|NCT01763827|3029959|Superiority or Other||Median Treatment Difference|-5.71||||0.082|2-Sided|95.0|-14.13|2.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647376|NCT01763827|3029959|Superiority or Other||Median Treatment Difference|-20.39|||<|0.001|2-Sided|95.0|-30.11|-10.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647377|NCT01763827|3029959|Superiority or Other||Median Treatment Difference|-4.59|||<|0.072|2-Sided|95.0|-11.3|2.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647378|NCT01763827|3029960|Superiority or Other||Median Treatment Difference|-13.23||||0.044|2-Sided|95.0|-21.69|-4.77||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647379|NCT01763827|3029960|Superiority or Other||Median Treatment Difference|-8.14||||0.027|2-Sided|95.0|-17.54|1.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647380|NCT01763827|3029960|Superiority or Other||Median Treatment Difference|-17.65|||<|0.001|2-Sided|95.0|-26.67|-8.63||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm||
1647381|NCT01763827|3029960|Superiority or Other||Median Treatment Difference|-6.23|||<|0.72|2-Sided|95.0|-16.41|3.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647382|NCT01763827|3029961|Superiority or Other||Median Treatment Difference|-11.73||||0.044|2-Sided|95.0|-21.19|-2.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647383|NCT01763827|3029961|Superiority or Other||Median Treatment Difference|-7.71||||0.027|2-Sided|95.0|-16.86|1.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647384|NCT01763827|3029961|Superiority or Other||Median Treatment Difference|-20.59|||<|0.001|2-Sided|95.0|-30.98|-10.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647385|NCT01763827|3029961|Superiority or Other||Median Treatment Difference|-5.27|||<|0.72|2-Sided|95.0|-13.27|2.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647386|NCT01763827|3029962|Superiority or Other||Median Treatment Difference|-15.77|||<|0.001|2-Sided|95.0|-24.39|-7.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647387|NCT01763827|3029962|Superiority or Other||Median Treatment Difference|-20.41|||<|0.001|2-Sided|95.0|-28.13|-12.69||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647388|NCT01763827|3029962|Superiority or Other||Median Treatment Difference|-17.82|||<|0.001|2-Sided|95.0|-24.51|-11.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647389|NCT01763827|3029962|Superiority or Other||Median Treatment Difference|-20.41|||<|0.001|2-Sided|95.0|-27.76|-13.06||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647390|NCT01763827|3029963|Superiority or Other||Median Treatment Difference|-17.15|||<|0.001|2-Sided|95.0|-23.23|-11.08||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647391|NCT01763827|3029963|Superiority or Other||Median Treatment Difference|-18.37|||<|0.001|2-Sided|95.0|-24.39|-12.35||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647392|NCT01763827|3029963|Superiority or Other||Median Treatment Difference|-19.24|||<|0.001|2-Sided|95.0|-23.2|-15.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647393|NCT01763827|3029963|Superiority or Other||Median Treatment Difference|-18.48|||<|0.001|2-Sided|95.0|-25.28|-11.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Quade test|Adjusted for Baseline value|Median difference and 95% CI were obtained from McKean-Schrader algorithm.||
1647394|NCT01763827|3029964|Superiority or Other||LS Mean Treatment Difference|-33.97|Standard Error of the Mean|2.29|<|0.001|2-Sided|95.0|-38.48|-29.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647395|NCT01763827|3029964|Superiority or Other||LS Mean Treatment Difference|-35.76|Standard Error of the Mean|2.13|<|0.001|2-Sided|95.0|-39.95|-31.57||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647396|NCT01763827|3029964|Superiority or Other||LS Mean Treatment Difference|-52.77|Standard Error of the Mean|2.29|<|0.001|2-Sided|95.0|-57.28|-48.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647397|NCT01763827|3029964|Superiority or Other||LS Mean Treatment Difference|-49.57|Standard Error of the Mean|2.14|<|0.001|2-Sided|95.0|-53.78|-45.36||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647398|NCT01763827|3029965|Superiority or Other||LS Mean Treatment Difference|-36.62|Standard Error of the Mean|2.13|<|0.001|2-Sided|95.0|-40.81|-32.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647399|NCT01763827|3029965|Superiority or Other||LS Mean Treatment Difference|-34.73|Standard Error of the Mean|2.03|<|0.001|2-Sided|95.0|-38.73|-30.73||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647400|NCT01763827|3029965|Superiority or Other||LS Mean Treatment Difference|-54.95|Standard Error of the Mean|2.12|<|0.001|2-Sided|95.0|-59.12|-50.78||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647401|NCT01763827|3029965|Superiority or Other||LS Mean Treatment Difference|-49.12|Standard Error of the Mean|2.03|<|0.001|2-Sided|95.0|-53.12|-45.12||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647402|NCT01763827|3029966|Superiority or Other||LS Mean Treatment Difference|-25.31|Standard Error of the Mean|2.03|<|0.001|2-Sided|95.0|-29.31|-21.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647403|NCT01763827|3029966|Superiority or Other||LS Mean Treatment Difference|-28.42|Standard Error of the Mean|1.68|<|0.001|2-Sided|95.0|-31.73|-25.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647404|NCT01763827|3029966|Superiority or Other||LS Mean Treatment Difference|-44.67|Standard Error of the Mean|2.03|<|0.001|2-Sided|95.0|-48.66|-40.68||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647405|NCT01763827|3029966|Superiority or Other||LS Mean Treatment Difference|-39.63|Standard Error of the Mean|1.69|<|0.001|2-Sided|95.0|-42.97|-36.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647406|NCT01763827|3029967|Superiority or Other||LS Mean Treatment Difference|-27.51|Standard Error of the Mean|1.81|<|0.001|2-Sided|95.0|-31.08|-23.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647407|NCT01763827|3029967|Superiority or Other||LS Mean Treatment Difference|-29.36|Standard Error of the Mean|1.56|<|0.001|2-Sided|95.0|-32.43|-26.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647408|NCT01763827|3029967|Superiority or Other||LS Mean Treatment Difference|-45.83|Standard Error of the Mean|1.81|<|0.001|2-Sided|95.0|-49.39|-42.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647491|NCT01763203|3030034|Superiority|||||||0.002|||||||Mixed Models Analysis||||
1647492|NCT01763203|3030036|Superiority|||||||0.77|||||||Mixed Models Analysis||||
1647409|NCT01763827|3029967|Superiority or Other||LS Mean Treatment Difference|-38.93|Standard Error of the Mean|1.56|<|0.001|2-Sided|95.0|-42.0|-35.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647410|NCT01763827|3029968|Superiority or Other||LS Mean Treatment Difference|-32.57|Standard Error of the Mean|1.85|<|0.001|2-Sided|95.0|-36.21|-28.92||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647411|NCT01763827|3029968|Superiority or Other||LS Mean Treatment Difference|-34.04|Standard Error of the Mean|1.9|<|0.001|2-Sided|95.0|-37.78|-30.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647412|NCT01763827|3029968|Superiority or Other||LS Mean Treatment Difference|-48.43|Standard Error of the Mean|1.85|<|0.001|2-Sided|95.0|-52.07|-44.79||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647413|NCT01763827|3029968|Superiority or Other||LS Mean Treatment Difference|-47.81|Standard Error of the Mean|1.91|<|0.001|2-Sided|95.0|-51.56|-44.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647414|NCT01763827|3029969|Superiority or Other||LS Mean Treatment Difference|-34.64|Standard Error of the Mean|1.71|<|0.001|2-Sided|95.0|-37.99|-31.28||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647415|NCT01763827|3029969|Superiority or Other||LS Mean Treatment Difference|-33.57|Standard Error of the Mean|1.82|<|0.001|2-Sided|95.0|-37.15|-29.99||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647416|NCT01763827|3029969|Superiority or Other||LS Mean Treatment Difference|-50.93|Standard Error of the Mean|1.7|<|0.001|2-Sided|95.0|-54.27|-47.59||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647417|NCT01763827|3029969|Superiority or Other||LS Mean Treatment Difference|-47.09|Standard Error of the Mean|1.82|<|0.001|2-Sided|95.0|-50.67|-43.51||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647418|NCT01763827|3029970|Superiority or Other||LS Mean Treatment Difference|-33.21|Standard Error of the Mean|1.68|<|0.001|2-Sided|95.0|-36.51|-29.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647419|NCT01763827|3029970|Superiority or Other||LS Mean Treatment Difference|-35.23|Standard Error of the Mean|1.78|<|0.001|2-Sided|95.0|-38.74|-31.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647420|NCT01763827|3029970|Superiority or Other||LS Mean Treatment Difference|-51.19|Standard Error of the Mean|1.67|<|0.001|2-Sided|95.0|-54.49|-47.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647421|NCT01763827|3029970|Superiority or Other||LS Mean Treatment Difference|-49.81|Standard Error of the Mean|1.79|<|0.001|2-Sided|95.0|-53.34|-46.27||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647422|NCT01763827|3029971|Superiority or Other||LS Mean Treatment Difference|-35.49|Standard Error of the Mean|1.5|<|0.001|2-Sided|95.0|-38.44|-32.53||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647423|NCT01763827|3029971|Superiority or Other||LS Mean Treatment Difference|-35.58|Standard Error of the Mean|1.63|<|0.001|2-Sided|95.0|-38.79|-32.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647424|NCT01763827|3029971|Superiority or Other||LS Mean Treatment Difference|-53.28|Standard Error of the Mean|1.5|<|0.001|2-Sided|95.0|-56.23|-50.33||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647425|NCT01763827|3029971|Superiority or Other||LS Mean Treatment Difference|-48.81|Standard Error of the Mean|1.63|<|0.001|2-Sided|95.0|-52.01|-45.61||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647426|NCT01763827|3029972|Superiority or Other||Treatment Difference|64.0|||<|0.001|2-Sided|95.0|53.5|71.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.|||
1647427|NCT01763827|3029972|Superiority or Other||Treatment Difference|71.5|||<|0.001|2-Sided|95.0|61.3|78.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.|||
1647428|NCT01763827|3029972|Superiority or Other||Treatment Difference|65.4|||<|0.001|2-Sided|95.0|55.6|72.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.|||
1647429|NCT01763827|3029972|Superiority or Other||Treatment Difference|71.5|||<|0.001|2-Sided|95.0|61.2|78.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.|||
1647430|NCT01763827|3029973|Superiority or Other||Treatment Difference|68.6|||<|0.001|2-Sided|95.0|58.3|75.5||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.|||
1647431|NCT01763827|3029973|Superiority or Other||Treatment Difference|72.2|||<|0.001|2-Sided|95.0|62.4|78.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.|||
1647432|NCT01763827|3029973|Superiority or Other||Treatment Difference|71.3|||<|0.001|2-Sided|95.0|62.2|78.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.|||
1647433|NCT01763827|3029973|Superiority or Other||Treatment Difference|73.6|||<|0.001|2-Sided|95.0|64.4|80.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Based on CMH test stratified by Baseline LDL-C level. For testing, non-achievement was imputed for participants with a missing value.|||
1647434|NCT01763827|3029974|Superiority or Other||LS Mean Treatment Difference|-52.9|Standard Error of the Mean|2.9|<|0.001|2-Sided|95.0|-58.5|-47.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe was the reference||
1647435|NCT01763827|3029974|Superiority or Other||LS Mean Treatment Difference|-55.0|Standard Error of the Mean|3.1|<|0.001|2-Sided|95.0|-61.1|-49.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe was the reference||
1647436|NCT01763827|3029974|Superiority or Other||LS Mean Treatment Difference|-77.8|Standard Error of the Mean|2.8|<|0.001|2-Sided|95.0|-83.4|-72.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647437|NCT01763827|3029974|Superiority or Other||LS Mean Treatment Difference|-80.4|Standard Error of the Mean|3.1|<|0.001|2-Sided|95.0|-86.4|-74.3||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647438|NCT01763827|3029975|Superiority or Other||LS Mean Treatment Difference|-56.1|Standard Error of the Mean|2.6|<|0.001|2-Sided|95.0|-61.1|-51.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647439|NCT01763827|3029975|Superiority or Other||LS Mean Treatment Difference|-55.3|Standard Error of the Mean|2.7|<|0.001|2-Sided|95.0|-60.7|-49.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference||
1647440|NCT01763827|3029975|Superiority or Other||LS Mean Treatment Difference|-81.9|Standard Error of the Mean|2.6|<|0.001|2-Sided|95.0|-87.0|-76.9||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647441|NCT01763827|3029975|Superiority or Other||LS Mean Treatment Difference|-79.6|Standard Error of the Mean|2.7|<|0.001|2-Sided|95.0|-85.0|-74.2||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1647442|NCT01763827|3029976|Superiority or Other||LS Mean Treatment Difference|-36.69|Standard Error of the Mean|1.66|<|0.001|2-Sided|95.0|-42.97|-36.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1647493|NCT01763203|3030037|Superiority|||||||0.73|||||||Mixed Models Analysis||||
1647569|NCT01758432|3030442|Superiority||Least Squares Means (Difference)|193684.5|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647443|NCT01763827|3029976|Superiority or Other||LS Mean Treatment Difference|-39.41|Standard Error of the Mean|1.76|<|0.001|2-Sided|95.0|-42.87|-35.94||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1647444|NCT01763827|3029976|Superiority or Other||LS Mean Treatment Difference|-57.4|Standard Error of the Mean|1.66|<|0.001|2-Sided|95.0|-60.66|-54.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647445|NCT01763827|3029976|Superiority or Other||LS Mean Treatment Difference|-56.5|Standard Error of the Mean|1.76|<|0.001|2-Sided|95.0|-59.95|-53.04||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at the mean of Weeks 10 and 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647446|NCT01763827|3029977|Superiority or Other||LS Mean Treatment Difference|-37.55|Standard Error of the Mean|1.88|<|0.001|2-Sided|95.0|-41.24|-33.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1647447|NCT01763827|3029977|Superiority or Other||LS Mean Treatment Difference|-39.29|Standard Error of the Mean|2.03|<|0.001|2-Sided|95.0|-43.28|-35.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Ezetimibe is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1647448|NCT01763827|3029977|Superiority or Other||LS Mean Treatment Difference|-54.78|Standard Error of the Mean|1.87|<|0.001|2-Sided|95.0|-58.46|-51.1||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model includes treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647449|NCT01763827|3029977|Superiority or Other||LS Mean Treatment Difference|-57.14|Standard Error of the Mean|2.03|<|0.001|2-Sided|95.0|-61.14|-53.14||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|The model included treatment group, Baseline LDL-C level, scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1647450|NCT01763788|3029991|Superiority||Stratified Hazard Ratio|0.656||||0.0161|2-Sided|95.0|0.465|0.926|||Stratified Log Rank||||
1647451|NCT01763567|3030003|Superiority or Other||% of false alert|56.5|||||2-Sided||||||||||
1647452|NCT01763567|3030004|Superiority or Other||% of false alert|85.8|||||2-Sided||||||||||
1647453|NCT01763567|3030005|Superiority or Other||percent of events correctly detected|88.9|||||2-Sided||||||||||
1647454|NCT01763567|3030006|Superiority or Other||percent of events correctly detected|16.7|||||2-Sided||||||||||
1647455|NCT01763567|3030007|Superiority or Other||Mean Difference (Final Values)|12.8|Standard Deviation|9.5|||2-Sided||||||||||
1647456|NCT01763346|3030010|Superiority|||||||0.05||||||35 subjects per group provided 80% power to detect an effect size of 0.59, assuming a 2-sided p=0.05, adjustment for baseline measures using ANCOVA, and correlation of 0.5 between baseline and end-study measures.|General Linear Models|Differences in primary outcomes between groups at 24-months were compared using general linear models with baseline values included as covariates.||We selected a sample size that would allow detection of an effect size of ~0.6 or greater between gastric band and metformin groups for measures of β-cell function after two years, hypothesizing greater function in the gastric band group.|
1647457|NCT01763333|3030013|Non-Inferiority or Equivalence|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|116.83|||||2-Sided|90.0|111.814|122.079|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.|
1647494|NCT01762982|3030044|Superiority or Other||Median Difference (Final Values)|0.0||||0.0547||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.|
1647495|NCT01762982|3030045|Superiority or Other||Median Difference (Final Values)|0.0||||0.0078||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.|
1647496|NCT01762982|3030048|Superiority or Other||Median Difference (Final Values)|0.0||||0.0654||95.0|||||Signed Rank Test|||Null hypothesis considered no treatment difference between the treatments being compared.|
1647458|NCT01763333|3030013|Non-Inferiority or Equivalence|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|137.2|||||2-Sided|90.0|119.611|157.374|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of R2 vs R1(PPS-BA-R2-R1) was used.|
1647459|NCT01763333|3030013|Non-Inferiority or Equivalence|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)|gMean ratio|74.42|||||2-Sided|90.0|65.979|83.941|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC 0-tz.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.|
1647460|NCT01763333|3030013|Non-Inferiority or Equivalence|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean)|gMean Ratio|86.16|||||2-Sided|90.0|75.735|98.027|||||Adjusted geometric mean (gMean) ratio.|Relative bioavailability comparison Tab. fed (T1) : Tab. fasted (R1) for AUC 0-tz. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.|
1647461|NCT01763333|3030013|Superiority or Other||Slope|0.9307|||||2-Sided|95.0|0.8187|1.0426|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.|This was non confirmatory testing (Single dose). Dose proportionality of solution for AUC0-tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.|
1647462|NCT01763333|3030013|Superiority or Other||Slope|0.8428|||||2-Sided|95.0|0.658|1.0275|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for AUC 0− tz was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.|
1647463|NCT01763333|3030014|Non-Inferiority or Equivalence|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|116.48|||||2-Sided|90.0|111.462|121.724|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.|
1647464|NCT01763333|3030014|Non-Inferiority or Equivalence|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|137.25|||||2-Sided|90.0|119.708|157.353|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.|
1647465|NCT01763333|3030014|Non-Inferiority or Equivalence|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|74.44|||||2-Sided|90.0|66.322|83.562|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for AUC0-inf.The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.|
1647466|NCT01763333|3030014|Non-Inferiority or Equivalence|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean Ratio|86.61|||||2-Sided|90.0|76.529|98.029|||||Adjusted gMean ratio.|Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for AUC0-inf. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.|
1647497|NCT01762943|3030050|Superiority|||||||0.018|||||||repeated measures ANOVA|F=6.29, df=1,28|||
1647498|NCT01762943|3030051|Superiority|||||||0.27|||||||repeated measures ANOVA|F=1.40, df=2,26|||
1647499|NCT01762904|3030053|Superiority or Other||||||<|0.05|||||||Kruskal-Wallis||||
1647500|NCT01762904|3030054|Superiority or Other||||||<|0.05|||||||Kruskal-Wallis||||
1647501|NCT01762904|3030055|Superiority or Other||||||<|0.05|||||||Kruskal-Wallis||||
1647467|NCT01763333|3030014|Superiority or Other||Slope|0.9149|||||2-Sided|95.0|0.8059|1.0239|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose).Dose proportionality of solution for AUC0-inf was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.|
1647468|NCT01763333|3030014|Superiority or Other||Slope|0.8341|||||2-Sided|95.0|0.6485|1.0198|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose).Dose proportionality of tablets for AUC0-inf was analysed.The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.|
1647469|NCT01763333|3030016|Non-Inferiority or Equivalence|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|105.47|||||2-Sided|90.0|85.427|130.208|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2): Tab. fed (T1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs T1 (PPS-BA-T2-T1) was used.|
1647470|NCT01763333|3030016|Non-Inferiority or Equivalence|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|239.63|||||2-Sided|90.0|197.445|290.83|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fasted (R2): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of R2 vs R1 (PPS-BA-R2-R1) was used.|
1647471|NCT01763333|3030016|Non-Inferiority or Equivalence|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|52.66|||||2-Sided|90.0|40.488|68.499|||||Adjusted gMean ratio.|Relative bioavailability comparison Sol. fed (T2) : Sol. fasted (R2) for Cmax. The per protocol set for the evaluation of relative bioavailability of T2 vs R2 (PPS-BA-T2-R2) was used.|
1647472|NCT01763333|3030016|Non-Inferiority or Equivalence|The pharmacokinetic parameters were log transformed (natural logarithm) prior to fitting the ANOVA model. The difference between the expected means of the 2 treatments of interest for each pairwise comparison were estimated by the difference in the corresponding Least Square Means (point estimate) and two-sided 90% confidence intervals based on the t-distribution were computed. These quantities were then back-transformed to the original scale to give the point estimator (geometric mean).|gMean ratio|112.74|||||2-Sided|90.0|95.579|132.993|||||Adjusted gMean ratio.|Relative bioavailability comparison Tab. fed (T1): Tab. fasted (R1) for Cmax. The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) was used.|
1647473|NCT01763333|3030016|Superiority or Other||Slope|0.9341|||||2-Sided|95.0|0.8277|1.0405|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of solution for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.|
1647474|NCT01763333|3030016|Superiority or Other||Slope|0.8728|||||2-Sided|95.0|0.6942|1.0513|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of tablets for Cmax was analysed. The per protocol set for the evaluation of dose proportionality (PPS-DP) was used. This set included all subjects of the TS-SRD who provided at least one observation for at least one of the endpoints Cmax, AUC0-tz, AUC0-∞, or Aet1-t2, without experiencing emesis at or before 2 times median tmax and without important PVs relevant to the statistical evaluation of PK.|
1647475|NCT01763203|3030018|Superiority|||||||0.25|||||||t-test, 2 sided||||
1647476|NCT01763203|3030019|Superiority|||||||0.8|||||||t-test, 2 sided||||
1647477|NCT01763203|3030020|Superiority|||||||0.93|||||||t-test, 2 sided||||
1647478|NCT01763203|3030021|Superiority|||||||0.45|||||||t-test, 2 sided||||
1647479|NCT01763203|3030022|Superiority|||||||0.2|||||||Mixed Models Analysis||||
1647480|NCT01763203|3030023|Superiority|||||||0.77|||||||Chi-squared||||
1647481|NCT01763203|3030024|Superiority|||||||0.32|||||||Mixed Models Analysis||||
1647482|NCT01763203|3030025|Superiority|||||||0.07|||||||Mixed Models Analysis||||
1647483|NCT01763203|3030026|Superiority|||||||0.0021|||||||Wilcoxon (Mann-Whitney)||||
1647484|NCT01763203|3030027|Superiority|||||||0.74|||||||Mixed Models Analysis||||
1647485|NCT01763203|3030028|Superiority|||||||0.58|||||||Mixed Models Analysis||||
1647486|NCT01763203|3030029|Superiority|||||||0.47|||||||Mixed Models Analysis||||
1647487|NCT01763203|3030030|Superiority|||||||0.011|||||||Mixed Models Analysis||||
1647488|NCT01763203|3030031|Superiority|||||||0.46|||||||Mixed Models Analysis||||
1647525|NCT01761084|3030203|Superiority||Mean Difference (Final Values)|-49.3|||<|0.05|2-Sided|95.0|-69.8|-28.8||Month 12 strength and balance physical activity|t-test, 2 sided|||Only Month 6 and Month 12 strength and balance physical activity differences were significant.|
1647526|NCT01761084|3030203|Superiority||Mean Difference (Final Values)|-65.9|||<|0.05|2-Sided|95.0|-91.8|-40.0||Month 6 strength and balance physical activity|t-test, 2 sided|||Only Month 6 and Month 12 strength and balance physical activity differences were significant.|
1647527|NCT01761084|3030204|Superiority||Mean Difference (Final Values)|-1.396||||0.039|2-Sided|95.0|-2.721|-0.071|||t-test, 2 sided|||Month 12|
1647528|NCT01761084|3030204|Superiority||Mean Difference (Final Values)|0.045||||0.951|2-Sided|95.0|-1.412|1.501|||t-test, 2 sided|||Baseline|
1647529|NCT01761084|3030207|Superiority||Mean Difference (Final Values)|0.23||||0.566|2-Sided|95.0|-0.57|1.04|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in pain VAS during movement|
1647530|NCT01761084|3030207|Superiority||Mean Difference (Final Values)|0.1||||0.808|2-Sided|95.0|-0.68|0.88|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in pain VAS during movement|
1647531|NCT01761084|3030207|Superiority||Mean Difference (Final Values)|-0.3||||0.488|2-Sided|95.0|-1.16|0.56|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in pain VAS at rest|
1647532|NCT01761084|3030207|Superiority||Mean Difference (Final Values)|-0.52||||0.225|2-Sided|95.0|-1.36|0.32|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in pain VAS at rest|
1647533|NCT01761084|3030207|Superiority||Mean Difference (Final Values)|0.18||||0.285|2-Sided|95.0|-0.15|0.5|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in OQLQ Average Score|
1647534|NCT01761084|3030207|Superiority||Mean Difference (Final Values)|0.16||||0.335|2-Sided|95.0|-0.16|0.47|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in OQLQ Average Score|
1647535|NCT01761084|3030207|Superiority||Mean Difference (Final Values)|1.78||||0.585|2-Sided|95.0|-4.66|8.22|||t-test, 2 sided||Per-protocol analysis|Comparison of change from baseline in EQ5D-VAS|
1647536|NCT01761084|3030207|Superiority||Mean Difference (Final Values)|0.59||||0.854|2-Sided|95.0|-5.66|6.83|||t-test, 2 sided||Intention-to-treat analysis|Comparison of change from baseline in EQ5D - VAS|
1647537|NCT01761084|3030208|Superiority||Mean Difference (Final Values)|0.11||||0.745|2-Sided|95.0|-0.56|0.79|||t-test, 2 sided||Per-protocol analysis|Month 12|
1647538|NCT01761084|3030208|Superiority||Mean Difference (Final Values)|0.12||||0.719|2-Sided|95.0|-0.54|0.78|||t-test, 2 sided||Intention-to-treat analysis|Baseline|
1647539|NCT01761084|3030209|Superiority||Mean Difference (Final Values)|-0.05||||0.888|2-Sided|95.0|-0.75|0.65|||t-test, 2 sided||Per-protocol analysis|Month 12|
1647540|NCT01761084|3030209|Superiority||Mean Difference (Final Values)|-0.09||||0.796|2-Sided|95.0|-0.8|0.61|||t-test, 2 sided||Intention-to-treat analysis|Baseline|
1647541|NCT01761084|3030210|Superiority||Mean Difference (Final Values)|0.14||||0.765|2-Sided|95.0|-0.8|1.09|||t-test, 2 sided||Per-protocol analysis|Month 12|
1647542|NCT01761084|3030210|Superiority||Mean Difference (Final Values)|0.12||||0.811|2-Sided|95.0|-0.84|1.07|||t-test, 2 sided|Intention-to-treat analysis|Intention-to-treat analysis|Baseline|
1647543|NCT01761084|3030211|Superiority||Risk Ratio (RR)|1.32|||||2-Sided|95.0|0.99|1.74|||||||
1647544|NCT01761084|3030212|Superiority||Odds Ratio (OR)|1.06|||||2-Sided|95.0|0.58|1.94|||||||
1647545|NCT01760304|3030283|Superiority or Other||||||<|0.05|||||||paired t-test||||
1647546|NCT01760304|3030285|Superiority or Other||||||<|0.0001|||||||paired T-test|||a paired t-test was calculated comparing baseline measures and post intervention|
1647547|NCT01760304|3030285|Superiority||||||<|0.769|||||||2-sided paired t-test|||a paired t-test was calculated comparing baseline measures and post intervention|
1647548|NCT01760239|3030286|Superiority||Odds Ratio (OR)|5.13||||0.001|2-Sided||||||Mixed Models Analysis||||
1647549|NCT01760239|3030287|Superiority||Odds Ratio (OR)|2.36||||0.046|2-Sided||||||Mixed Models Analysis||||
1647550|NCT01760239|3030288|Superiority||Odds Ratio (OR)|4.51|||<|0.001|2-Sided||||||Mixed Models Analysis||||
1647551|NCT01759862|3030316|Superiority|||||||0.67|||||||Chi-squared||||
1647552|NCT01759862|3030317|Superiority|Enrolling 25 patients in each group will allow us to detect a difference of 200ng/mg cr in urinary NGAL levels between the two groups with a power of 80% and a two-sided type I probability error of 0.05.||||||0.95|||||||Kruskal-Wallis||||
1647553|NCT01759862|3030318|Superiority|Our calculations showed that by enrolling 50 patients we will be able to detect a 25cc/min absolute difference in eGFR between the two arms with power above 80%, and a two-sided Type I probability error of <0.05.||||||0.32|||||||t-test, 2 sided|||Intention to treat analysis|
1647554|NCT01758588|3030428|Other||||||||||||||||||A statistical comparison and analysis of the clinical improvement (CI) proportions cannot be made because the sample size (n=5 in treatment arm, n=3 in observation arm) is too small
1647555|NCT01758523|3030429|Other|||||||0.03|||||||t-test, 2 sided||||
1647556|NCT01758523|3030430|Other|||||||0.87||||||significance for drug x AKR1C3*2 G-carrier genotype|Mixed Models Analysis||||
1647557|NCT01758523|3030431|Other||Odds Ratio (OR)|5.5||||0.007|2-Sided|95.0|1.5|20.7|||Fisher Exact||||
1647558|NCT01758523|3030432|Other||Odds Ratio (OR)|2.49||||0.057|2-Sided|95.0|0.96|6.45|||Chi-squared||||
1647559|NCT01758523|3030433|Other|||||||0.028|||||||Mixed Models Analysis||||
1647560|NCT01758523|3030434|Other|||||||0.002|||||||Mixed Models Analysis||||
1647561|NCT01758432|3030441|Superiority||Least Squares Means (Difference)|-6.71|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647562|NCT01758432|3030441|Superiority||Least Squares Means (Difference)|-7.49|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647563|NCT01758432|3030441|Superiority||Least Squares Means (Difference)|-6.79|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647564|NCT01758432|3030441|Superiority||Least Squares Means (Difference)|-6.15|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647565|NCT01758432|3030441|Superiority||Least Squares Means (Difference)|-4.29|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647566|NCT01758432|3030441|Superiority||Least Squares Means (Difference)|-4.58|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647574|NCT01758432|3030443|Superiority||Least Squares Means (Difference)|-167.94|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647575|NCT01758432|3030443|Superiority||Least Squares Means (Difference)|-165.91|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647576|NCT01758432|3030443|Superiority||Least Squares Means (Difference)|-129.86|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647577|NCT01758432|3030443|Superiority||Least Squares Means (Difference)|-130.5|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647578|NCT01758432|3030443|Superiority||Least Squares Means (Difference)|-95.74|||<|0.0001|2-Sided|95.0|||||ANCOVA||||
1647579|NCT01757704|3030461|Superiority or Other||Median Difference (Net)|56.0|||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)||||
1647580|NCT01757678|3030472|Other||Difference in Probability|0.09|||||2-Sided|95.0|0.04|0.14|||||||
1647581|NCT01757678|3030473|Other||Difference in Probability|0.14|||||2-Sided|95.0|0.09|0.19|||||||
1647582|NCT01757665|3030506|Superiority||percent of patients|0.1|||||1-Sided|95.0||0.7|||||Upper 95% CI was calculated by the method of Clopper and Pearson, using the Beta distribution with parameters x + 1 and n - x where x is the number of SVD events by POD 390 and n is the number of subjects followed at the 1 year assessment.|The null hypothesis is that the rate of structural valve deterioration at one year is greater than 1%. The alternative hypothesis is that this rate is less than 1%.|
1647583|NCT01757405|3030518|Non-Inferiority or Equivalence (legacy)|Equivalence of treatment success proportions in all bleeding episodes for the two treatment groups was determined by comparing the 90% two-sided CI of the ratio of success proportions to the equivalence region defined as [0.83, 1.20].|Ratio of success proportion|1.21|||||2-Sided|90.0|1.15|1.28||||||"Equivalence test of successfully treated bleeding episodes (BEs) between or within treatment arms.~Denoting the success rates in the two treatment groups by p1 and p2 , the null hypotheses of H01 :~p1/p2 < 0.83 and H02 : p1/p2 > 1.20 was implicitly tested against the one-sided alternatives Ha1: 0.83 ≤ p1/p2 and Ha2 : p1/p2 ≤ 1.20, by comparing the 90% two-sided confidence interval (CI) of the ratio of success proportions to the equivalence region defined as [0.83, 1.20]."|
1647584|NCT01757197|3030536|Other|Not evaluable.|Other|0.0|||||2-Sided|||||||||Not evaluable.|Not evaluable.
1647585|NCT01757184|3030537|Superiority|||||||0.0068|||||||Wilcoxon (Mann-Whitney)||||
1647586|NCT01757184|3030538|Superiority|||||||0.4216|||||||Fisher Exact||||
1647587|NCT01757184|3030539|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1647588|NCT01757184|3030540|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1647589|NCT01757184|3030541|Superiority|||||||0.0375|||||||Wilcoxon (Mann-Whitney)||||
1647590|NCT01757184|3030542|Superiority|||||||0.0003|||||||Fisher Exact||||
1647591|NCT01757184|3030543|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1647592|NCT01757184|3030544|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1647593|NCT01757184|3030545|Superiority|||||||0.0271|||||||Fisher Exact|Fisher’s exact test at α=0.05.||A sample size of 50 randomized participants (approximately 25 participants per treatment group) provided 97% power to detect a statistically significant difference between sebelipase alfa and placebo, using Fisher’s exact test at α=0.05.|
1647594|NCT01756456|3030561|Superiority||difference in percentage|19.0|||=|0|2-Sided|95.0|-0.91|38.83|||Chi-squared|||week 8|
1647595|NCT01756456|3030561|Superiority||difference in percentage|27.5|||=|0|2-Sided|95.0|8.33|46.67|||Chi-squared|||week 8|
1647596|NCT01756456|3030561|Superiority||difference in percentage|11.0|||=|0|2-Sided|95.0|-9.64|31.57|||Chi-squared|||week 6|
1647597|NCT01756456|3030561|Superiority||difference in percentage|16.9|||=|0|2-Sided|95.0|-3.11|37.0|||Chi-squared|||week 6|
1647598|NCT01756456|3030561|Superiority||difference in percentage|13.2|||=|0|2-Sided|95.0|-5.72|32.15|||Chi-squared|||week 4|
1647599|NCT01756456|3030561|Superiority||difference in percentage|15.8|||=|0|2-Sided|95.0|-2.36|33.97|||Chi-squared|||week 4|
1647600|NCT01756456|3030566|Superiority||Odds Ratio (OR)|1.93|||=|0|2-Sided|95.0|0.82|4.52|||Chi-squared|||week 8|
1647601|NCT01756456|3030566|Superiority||Odds Ratio (OR)|2.47|||=|0|2-Sided|95.0|1.04|5.88|||Chi-squared|||week 8|
1647602|NCT01756456|3030566|Superiority||Odds Ratio (OR)|1.95|||=|0|2-Sided|95.0|0.92|4.11|||Chi-squared|||week 4|
1647603|NCT01756456|3030566|Superiority||Odds Ratio (OR)|2.18|||=|0|2-Sided|95.0|1.03|4.62|||Chi-squared|||week 4|
1647604|NCT01756456|3030568|Superiority||difference in percentage|-7.9|||=|0|2-Sided|95.0|-29.51|13.52|||Chi-squared|||week 8|
1647605|NCT01756456|3030568|Superiority||difference in percentage|-10.8|||=|0|2-Sided|95.0|-31.3|10.35|||Chi-squared|||week 8|
1647606|NCT01756456|3030568|Superiority||difference in percentage|-10.0|||=|0|2-Sided|95.0|-31.41|11.88|||Chi-squared|||week 6|
1647607|NCT01756456|3030568|Superiority||difference in percentage|-7.8|||=|0|2-Sided|95.0|-28.7|13.76|||Chi-squared|||week 6|
1647608|NCT01756456|3030568|Superiority||difference in percentage|-2.3|||>|0.999|2-Sided|95.0|-23.26|18.71|||Chi-squared|||week 4|
1647609|NCT01756456|3030568|Superiority||difference in percentage|-2.6|||=|0|2-Sided|95.0|-22.87|17.71|||Chi-squared|||week 4|
1647610|NCT01756456|3030569|Superiority||difference in percentage|7.9|||=|0|2-Sided|95.0|-12.13|27.92|||Chi-squared|||week 8|
1647611|NCT01756456|3030569|Superiority||difference in percentage|10.2|||=|0|2-Sided|95.0|-9.15|29.45|||Chi-squared||||
1647612|NCT01756456|3030569|Superiority||difference in percentage|12.4|||=|0|2-Sided|95.0|-9.91|34.68|||Chi-squared|||week 6|
1647613|NCT01756456|3030569|Superiority||difference in percentage|27.7|||=|0|2-Sided|95.0|8.1|47.22|||Chi-squared|||week 6|
1647614|NCT01756456|3030569|Superiority|week 4|difference in percentage|-2.3|||=|0|2-Sided|95.0|-24.01|19.4|||Chi-squared||||
1647615|NCT01756456|3030569|Superiority||difference in percentage|5.5|||=|0|2-Sided|95.0|-14.53|25.48|||Chi-squared|||week 4|
1647616|NCT01756456|3030570|Superiority||least square mean difference|5.0|||=|0|2-Sided|95.0|-2.9|12.88|||ANCOVA||||
1647617|NCT01756456|3030570|Superiority||least square mean difference|8.9|||=|0|2-Sided|95.0|1.33|16.5|||ANCOVA||||
1647618|NCT01756456|3030571|Superiority||difference in percentage|11.4|||=|0|2-Sided|95.0|-4.08|26.93|||Chi-squared|||week 8|
1647619|NCT01756456|3030571|Superiority||difference in percentage|17.1|||=|0|2-Sided|95.0|1.45|32.72|||Chi-squared|||week 8|
1647620|NCT01756456|3030571|Superiority||difference in percentage|15.6|||=|0|2-Sided|95.0|0.04|31.12|||Chi-squared|||week 6|
1647621|NCT01756456|3030571|Superiority||difference in percentage|16.9|||=|0|2-Sided|95.0|1.97|31.92|||Chi-squared|||week 6|
1647622|NCT01756456|3030571|Superiority||difference in percentage|12.4|||=|0|2-Sided|95.0|-2.05|26.78|||Chi-squared|||week 4|
1647623|NCT01756456|3030571|Superiority||difference in percentage|13.7|||=|0|2-Sided|95.0|-0.19|27.57|||Chi-squared|||week 4|
1647624|NCT01756456|3030572|Superiority||Difference in percentage|25.9|||=|0|2-Sided|97.06|3.55|48.33|||Chi-squared|||week 8 - investigator|
1647625|NCT01756456|3030572|Superiority||Difference in percentage|26.1|||=|0|2-Sided|97.06|4.18|48.01|||Chi-squared|||week 8 - investigator|
1647626|NCT01756456|3030572|Superiority||difference in percentage|26.9|||=|0|2-Sided|97.06|5.57|48.28|||Chi-squared|||week 8 - central reading center|
1647627|NCT01756456|3030572|Superiority||Difference in percentage|21.9|||=|0|2-Sided|97.06|0.07|43.64|||Chi-squared|||week 8 - central reading center|
1647628|NCT01756456|3030572|Superiority||Difference in percentage|23.1|||=|0|2-Sided|97.06|-0.89|47.04|||Chi-squared|||week 6 - investigator|
1647629|NCT01756456|3030572|Superiority||Difference in percentage|20.3|||=|0|2-Sided|97.06|-3.11|43.79|||Chi-squared|||week 6 - investigator|
1647630|NCT01756456|3030572|Superiority||difference in percentage|-6.3|||=|0|2-Sided|97.06|-30.62|17.96|||Chi-squared|||at week 6 - central reading center|
1647631|NCT01756456|3030572|Superiority||difference in percentage|2.4|||=|0|2-Sided|97.06|-20.3|25.08|||Chi-squared|||At week 6 - reading center|
1647632|NCT01756456|3030573|Superiority||Difference in percentage|34.7|||=|0|2-Sided|97.06|11.91|57.41|||Chi-squared||||
1647633|NCT01756456|3030573|Superiority||Difference in percentage|25.8|||=|0|2-Sided|97.06|3.66|47.87|||Chi-squared||||
1647634|NCT01756456|3030574|Superiority|Each of the comparisons was conducted on the data for the Phase II segment of the study using a 2 × 2 chi-square test, based on the null hypothesis that there is no association between treatment (rhNGF or Vehicle Control) and response (Complete Healing at Week 4 [Yes/No]).|Difference in percentage|38.4|||=|0|2-Sided|97.06|18.96|57.83|||Chi-squared||||
1647635|NCT01756456|3030574|Superiority|Each of the comparisons was conducted on the data for the Phase II segment of the study using a 2 × 2 chi-square test, based on the null hypothesis that there is no association between treatment (rhNGF or Vehicle Control) and response (Complete Healing at Week 4 [Yes/No]).|Difference in percentage|35.3|||<|0.001|2-Sided|97.06|15.88|54.71|||Chi-squared|||Phase II|
1647636|NCT01756157|3030624|Superiority or Other||Mean difference|-0.61||||0.0523|2-Sided|95.0|-1.23|0.01|||Paired t-test, 2 sided||||
1647637|NCT01755949|3030637|Superiority|||||||0.08|||||||t-test, 2 sided|||placebo vs colchicine|
1647638|NCT01755949|3030638|Superiority|||||||0.072|||||||t-test, 2 sided|||difference between placebo and colchicine levels at day 28|
1647639|NCT01755949|3030638|Superiority|||||||0.98|||||||t-test, 2 sided|||Baseline C-reactive protein vs day 28 C-reactive protein|
1647640|NCT01755949|3030638|Superiority|||||||0.038|||||||t-test, 2 sided|||Baseline C-reactive protein vs day 28 C-reactive protein|
1647641|NCT01755702|3030647|Superiority or Other||Hazard Ratio (HR)|0.95||||0.8192|2-Sided|95.0|0.62|1.45|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.|
1647642|NCT01755702|3030647|Superiority or Other||Hazard Ratio (HR)|1.08||||0.7214|2-Sided|95.0|0.72|1.61|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.|
1647643|NCT01755702|3030647|Superiority or Other||Hazard Ratio (HR)|1.13||||0.5579|2-Sided|95.0|0.75|1.71|||Cox Proportional Hazard Model||||
1647644|NCT01755702|3030647|Superiority or Other||Hazard Ratio (HR)|1.17||||0.4552|2-Sided|95.0|0.78|1.74|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.|
1647645|NCT01755702|3030647|Superiority or Other||Hazard Ratio (HR)|1.32||||0.2008|2-Sided|95.0|0.86|2.01|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.|
1647646|NCT01755702|3030647|Superiority or Other||Hazard Ratio (HR)|1.25||||0.284|2-Sided|95.0|0.83|1.9|||Cox Proportional Hazard Model|||Null hypothesis considered no difference between the treatments in comparison.|
1647647|NCT01755689|3030665|Non-Inferiority|For anti-PT the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.39|||||2-Sided|95.0|1.2|1.61||||||Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-PT titers.|
1647648|NCT01755689|3030665|Non-Inferiority|For anti-FHA the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.65|||||2-Sided|95.0|1.42|1.93||||||Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-FHA titers.|
1647649|NCT01755689|3030665|Non-Inferiority|For anti-PRN the UL of the 2-sided standardised asymptotic 95% CI for the adjusted group ratio of GMCs (Nimenrix+Cervarix+Boostrix Group/Boostrix+Cervarix Group) had to be less than or equal to the pre-defined limit of 1.5.|Adjusted GMT Ratio|1.53|||||2-Sided|95.0|1.25|1.87||||||Adjusted GMT ratio of the Nimenrix+Cervarix+Boostrix Group versus Boostrix+ Cervarix Group in terms of anti-PRN titers.|
1647650|NCT01755689|3030666|Non-Inferiority|For anti-T the LL of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.|Difference between groups|-0.4|||||2-Sided|95.0|-2.23|1.08||||||The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-T titers.|
1648032|NCT01751061|3031355|Superiority||||||<|0.05||||||P values were calculated.|generalized linear model||||
1647651|NCT01755689|3030666|Non-Inferiority|For anti-D the lower limit (LL) of the 2-sided standardised asymptotic 95% CI for the group difference (Nimenrix+Cervarix+Boostrix Group minus Boostrix +Cervarix Group) had to be greater than or equal to the pre-defined limit of -10%.|Difference between groups|-2.88|||||2-Sided|95.0|-6.9|0.81||||||The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-D titers.|
1647652|NCT01755689|3030667|Non-Inferiority|For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.19|||||2-Sided|95.0|1.0|1.41||||||Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-18 titers.|
1647653|NCT01755689|3030667|Non-Inferiority|For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.2|||||2-Sided|95.0|1.01|1.43||||||Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-16 titers.|
1647654|NCT01755689|3030667|Non-Inferiority|For HPV-18, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|1.09|||||2-Sided|95.0|0.92|1.29||||||Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-18 titers.|
1647655|NCT01755689|3030667|Non-Inferiority|For HPV-16, one month after the third dose of Cervarix, the UL of the two-sided standardized asymptotic 95% CI on the group GMT ratio had to be below the pre-defined limit of 2.|Adjusted GMT|0.97|||||2-Sided|95.0|0.81|1.15||||||Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-16 titers.|
1647656|NCT01755689|3030668|Non-Inferiority|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.95|||||2-Sided|95.0|0.8|1.12||||||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenY titers.|
1647657|NCT01755689|3030668|Non-Inferiority|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.05|||||2-Sided|95.0|0.89|1.24||||||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenY titers.|
1647658|NCT01755689|3030668|Non-Inferiority|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.82|||||2-Sided|95.0|0.63|1.07||||||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenW-135 titers.|
1647659|NCT01755689|3030668|Non-Inferiority|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.26|||||2-Sided|95.0|0.97|1.64||||||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenW-135 titers.|
1647660|NCT01755689|3030668|Non-Inferiority|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|0.83|||||2-Sided|95.0|0.66|1.06||||||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenC titers.|
1647661|NCT01755689|3030668|Non-Inferiority|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.19|||||2-Sided|95.0|0.93|1.51||||||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenC titers.|
1647662|NCT01755689|3030668|Non-Inferiority|The non-inferiority criteria: the UL of the 2-sided standardised asymptotic 95% CI for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.01|||||2-Sided|95.0|0.84|1.21||||||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenA titers.|
1647663|NCT01755689|3030668|Non-Inferiority|The non-inferiority criteria: the upper limit (UL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the ratio of rSBA GMTs had to be below the pre-defined limit of 2.|Adjusted GMT Ratio|1.19|||||2-Sided|95.0|0.99|1.43||||||Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenA titers.|
1647664|NCT01755637|3030669|Non-Inferiority or Equivalence|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range of 70% -143%.|Geometric mean ratio of treatments|114.33|||||2-Sided|90.0|102.99|126.93|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.|
1647665|NCT01755637|3030670|Non-Inferiority or Equivalence|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|113.1|||||2-Sided|90.0|103.4|123.71|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.|
1647666|NCT01755637|3030671|Non-Inferiority or Equivalence|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|112.05|||||2-Sided|90.0|103.65|121.12|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.|
1647667|NCT01755637|3030672|Superiority or Other||Median Difference (Final Values)|0.0167||||0.0011||95.0|||||Wilcoxon signed rank test|The values were not adjusted for this non-parametric analysis.|The median difference was calculated as = (Experimental-Reference)|The null hypothesis considered that there is no median within-subject difference between two treatment groups.|
1647962|NCT01751646|3031267|Other|||||||0.4686|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)|
1647668|NCT01755637|3030673|Non-Inferiority or Equivalence|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range of 70% -143%.|Geometric mean ratio of treatments|111.28|||||2-Sided|90.0|94.76|130.68|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.|
1647669|NCT01755637|3030674|Non-Inferiority or Equivalence|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean ratio of treatments|107.41|||||2-Sided|90.0|69.03|167.13|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.|
1647670|NCT01755637|3030675|Non-Inferiority or Equivalence|The bioequivalence between the two products was concluded if the 90% CIs (based on log transformed data and anti-logged) for the ratio of the geometric means lie completely within the range 80%-125%|Geometric mean Ratio of treatments|114.37|||||2-Sided|90.0|100.49|130.16|||||Geometric mean ratio of experimental and reference product was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.|
1647671|NCT01755598|3030689|Other|Vaccine efficacy (VE) has been estimated from a Cox proportional hazard regression model (VE=1-hazard ratio) and 90% confidence intervals (CIs) and Wald p-value has been derived. If the primary objective is met, this secondary objective is to be analysed using the following success criterion: The lower limit of the 90% two-sided CI for the VE against first occurrence of Definite pulmonary TB disease not associated with HIV infection, meeting the case definition 2, is to be above 0%.|Vaccine efficacy rate|61.67||||0.021|2-Sided|90.0|24.084|80.647|||Regression, Cox|||To evaluate the protective efficacy of two doses of the M72/AS01E candidate vaccine against Definite Xpert MTB/Rif positive pulmonary TB disease not associated with HIV-infection, meeting the case definition 2, as compared to placebo.|
1647672|NCT01755598|3030690|Other|Vaccine efficacy (VE) has been estimated from a Cox proportional hazard regression model (VE=1-hazard ratio) and 90% confidence intervals (CIs) and Wald p-value has been derived. The lower limit of the 90% two-sided CI for the VE against first occurrence of Definite pulmonary TB disease not associated with HIV-infection, meeting the case definition 1, is to be above 0%.|Vaccine efficacy rate|49.7||||0.043|2-Sided|90.0|12.1|71.2|||Regression, Cox|||To evaluate the protective efficacy of two doses of the M72/AS01E candidate vaccine against Definite pulmonary TB disease not associated with HIV-infection, meeting the case definition 1, as compared to placebo.|
1647673|NCT01755455|3030692|Superiority or Other|||||||0.16|||||||Fixed-effect model||||
1647674|NCT01755455|3030693|Superiority or Other||||||<|0.05|||||||Fixed-effect model|||Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).|
1647675|NCT01755455|3030694|Superiority or Other||||||<|0.05|||||||Fixed-effect model||||
1647676|NCT01755455|3030695|Superiority or Other|||||||0.81|||||||Fixed-effect model|||Fixed-effect models accounted for repeated measurements within subjects and treatment sequence. The estimated effect signifies the absolute change from baseline at 6 weeks in the specified outcome measure and (standard error).|
1647677|NCT01755234|3030697|Superiority or Other|||||||0.84|||||||Wilcoxon (Mann-Whitney)||||
1647678|NCT01755234|3030698|Superiority or Other|||||||0.96|||||||Wilcoxon (Mann-Whitney)||||
1647679|NCT01755234|3030699|Superiority or Other|||||||0.96|||||||Wilcoxon (Mann-Whitney)||||
1647680|NCT01755234|3030700|Superiority or Other|||||||0.97|||||||Wilcoxon (Mann-Whitney)||||
1647681|NCT01755156|3030705|Superiority or Other||Kaplan-Meier difference %|-1.2||||0.654|2-Sided|95.0|-7.0|4.7|||Log Rank||||
1647682|NCT01755156|3030707|Superiority or Other||Difference in least squares means|3.7||||0.025|2-Sided|95.0|0.5|6.9|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.|||
1647683|NCT01755156|3030708|Superiority or Other||Difference in least squares means|-27.8||||0.001|2-Sided|95.0|-44.8|-10.8|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.|||
1647684|NCT01755156|3030711|Superiority or Other||Between-group rate difference (%)|4.2||||0.164|2-Sided|95.0|-1.8|10.5|||Miettinen & Nurminen method||||
1647685|NCT01755156|3030712|Superiority or Other||Between-group rate difference (%)|19.2|||<|0.001|2-Sided|95.0|10.1|28.0|||Miettinen & Nurminen method||||
1647686|NCT01755156|3030715|Superiority or Other||Difference in least squares means|-9.5||||0.01|2-Sided|95.0|-16.7|-2.3|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.|||
1647687|NCT01755156|3030716|Superiority or Other||Difference in %|-14.5||||0.011|2-Sided|95.0|-25.6|-3.4|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.|||
1647688|NCT01755156|3030717|Superiority or Other||Difference in %|4.5|||||2-Sided|95.0|-3.3|12.3|||||||
1647689|NCT01755156|3030718|Superiority or Other||Difference in %|-2.5|||||2-Sided|95.0|-6.6|1.1|||||Based on Miettinen & Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.||
1647690|NCT01755156|3030719|Superiority or Other||Difference in %|0.5|||||2-Sided|95.0|-8.8|9.8|||||Based on Miettinen & Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in 1 or more treatment groups.||
1647691|NCT01755156|3030720|Superiority or Other||Difference in least squares means|-0.55|||<|0.001|2-Sided|95.0|-0.75|-0.34|||cLDA|Based on a cLDA method with a restriction of the same baseline mean.|||
1647692|NCT01755143|3030721|Non-Inferiority or Equivalence|The non-inferiority margin was 10%.|Risk Difference (RD)|0.2||||0.0004|1-Sided|95.0|-4.8||||Farrington-Manning test|A priori threshold for statistical significance was 0.05.||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|
1647693|NCT01755143|3030722|Superiority or Other||Percentage|0.0|||<|0.0001|1-Sided|95.0||1.9|||exact test of binomial proportions|A priori threshold for statistical significance was 0.05.||Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans >= 10%.|
1647694|NCT01755143|3030723|Non-Inferiority or Equivalence|The non-inferiority margin was 10%.|Risk Difference (RD)|1.6|||<|0.0001|1-Sided|95.0|-3.2|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|
1647695|NCT01755143|3030724|Non-Inferiority or Equivalence|The non-inferiority margin was 10%.|Risk Difference (RD)|-0.7|||<|0.0001|2-Sided|95.0|-5.4|4.1||A priori threshold for statistical significance was 0.025.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.|
1647696|NCT01755143|3030725|Non-Inferiority or Equivalence|The non-inferiority margin was 10%.|Risk Difference (RD)|0.0|||||2-Sided|||||||||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.|
1647697|NCT01755143|3030726|Superiority or Other||Percentage|100.0|||<|0.0001|1-Sided|97.5|97.7|||A priori threshold for statistical significance was 0.025|exact test of binomial proportions|||Null Hypothesis: MRI-related complication-free rate between the MRI scan and one-month post-MRI <90%.|
1647698|NCT01755026|3030733|Superiority or Other||Mean Difference (Net)|191.0|Standard Error of the Mean|166.01|<|0.01|2-Sided|95.0|||||t-test, 2 sided||||
1647699|NCT01754909|3030743|Superiority|Occurrence rates, comparison by t test||||||0.05|||||||t-test, 2 sided||||
1647700|NCT01754493|3030790|Superiority or Other||Slope|-4.38|||<|0.05|2-Sided|95.0|-7.39|-1.36|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in PHQ-15 scores of somatization symptoms. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.|
1647701|NCT01754493|3030791|Superiority or Other||Slope|-0.48|||<|0.05|2-Sided|95.0|-2.0|1.03|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of shoulder pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.|
1647702|NCT01754493|3030791|Superiority or Other||Slope|-0.35|||<|0.05|2-Sided|95.0|-1.56|0.87|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of back pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.|
1647703|NCT01754493|3030791|Superiority or Other||Slope|-0.59|||<|0.05|2-Sided|95.0|-2.28|1.1|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of headaches. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.|
1647704|NCT01754493|3030791|Superiority or Other||Slope|0.47|||<|0.05|2-Sided|95.0|-1.07|2.01|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This repeated-measures mixed-effects regression analysis assessed the rate of change in VAS score of pain interfering with daily activities. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a 1st-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis|
1647705|NCT01754493|3030791|Superiority or Other||Slope|-0.03|||<|0.05|2-Sided|95.0|-1.16|1.1|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of overall pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.|
1647706|NCT01754493|3030792|Superiority or Other||Slope|-1.55|||<|0.05|2-Sided|95.0|-1.99|-1.11|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-IBS score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.|
1647707|NCT01754493|3030792|Superiority or Other||Slope|-1.59|||<|0.05|2-Sided|95.0|-2.16|-1.03|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-MDD score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.|
1647708|NCT01754493|3030793|Superiority or Other||Slope|-20.71|||<|0.05|2-Sided|95.0|-27.44|-13.97|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total GSRS symptom scores for IBS. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.|
1647758|NCT01753856|3030860|Superiority or Other||||||<|0.001||||||sLS/BS, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647709|NCT01754493|3030794|Superiority or Other||Slope|-18.24|||<|0.05|2-Sided|95.0|-23.44|-12.63|||Mixed Models Analysis|||We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total MADRS symptom scores for MDD. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.|
1647710|NCT01754129|3030843|Other||||||<|0.001|||||||Paired t-test|||Change from baseline to Visit 2|
1647711|NCT01754129|3030843|Other||||||<|0.001||||||Missing values were replaced using the Last Observation Carried Forward (LOCF) technique for data of questionnaires. Missing data at Visit 3 was replaced with the (non-missing) data recorded at Visit 2.|Paired t-test|||Mean change from baseline to Visit 3|
1647712|NCT01753856|3030848|Superiority or Other||||||<|0.001||||||IC|Wilcoxon (Mann-Whitney)||||
1647713|NCT01753856|3030848|Superiority or Other||||||<|0.001||||||EC|Wilcoxon (Mann-Whitney)||||
1647714|NCT01753856|3030848|Superiority or Other||||||<|0.001||||||CC|Wilcoxon (Mann-Whitney)||||
1647715|NCT01753856|3030849|Superiority or Other|||||||0.678||||||IC.|Wilcoxon (Mann-Whitney)||||
1647716|NCT01753856|3030849|Superiority or Other|||||||0.042||||||EC.|Wilcoxon (Mann-Whitney)||||
1647717|NCT01753856|3030849|Superiority or Other||||||<|0.001||||||CC.|Wilcoxon (Mann-Whitney)||||
1647718|NCT01753856|3030850|Superiority or Other|||||||0.85||||||Average length of double labels in the PC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.|||
1647719|NCT01753856|3030850|Superiority or Other||||||<|0.001||||||Average length of double labels in IC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.|||
1647720|NCT01753856|3030850|Superiority or Other||||||<|0.004||||||Average length of double labels in EC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.|||
1647721|NCT01753856|3030850|Superiority or Other||||||<|0.001||||||Average length of DLs in the CC|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.|||
1647722|NCT01753856|3030851|Superiority or Other||||||<|0.001||||||IC.|Wilcoxon (Mann-Whitney)||||
1647723|NCT01753856|3030851|Superiority or Other||||||<|0.001||||||EC.|Wilcoxon (Mann-Whitney)||||
1647724|NCT01753856|3030851|Superiority or Other||||||<|0.001||||||CC.|Wilcoxon (Mann-Whitney)||||
1647725|NCT01753856|3030852|Superiority or Other||||||<|0.001||||||IC.|Wilcoxon (Mann-Whitney)||||
1647726|NCT01753856|3030852|Superiority or Other||||||<|0.001||||||EC.|Wilcoxon (Mann-Whitney)||||
1647727|NCT01753856|3030852|Superiority or Other||||||<|0.001||||||CC.|Wilcoxon (Mann-Whitney)||||
1647728|NCT01753856|3030853|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1647729|NCT01753856|3030854|Superiority or Other||||||<|0.001||||||DL and Imputed SL, in IC.|Wilcoxon (Mann-Whitney)||||
1647730|NCT01753856|3030854|Superiority or Other||||||<|0.001||||||DL Only, in IC.|Wilcoxon (Mann-Whitney)||||
1647731|NCT01753856|3030854|Superiority or Other||||||<|0.031||||||DL and Imputed SL, in EC.|Wilcoxon (Mann-Whitney)||||
1647732|NCT01753856|3030854|Superiority or Other||||||<|0.214||||||DL Only, in EC.|Wilcoxon (Mann-Whitney)||||
1647733|NCT01753856|3030854|Superiority or Other||||||<|0.001||||||DL and Imputed SL, in CC.|Wilcoxon (Mann-Whitney)||||
1647734|NCT01753856|3030854|Superiority or Other||||||<|0.002||||||DL Only, in CC.|Wilcoxon (Mann-Whitney)||||
1647735|NCT01753856|3030855|Superiority or Other||||||<|0.001||||||DL and Imputed SL, in IC.|Wilcoxon (Mann-Whitney)||||
1647736|NCT01753856|3030855|Superiority or Other||||||<|0.001||||||DL Only, in IC.|Wilcoxon (Mann-Whitney)||||
1647737|NCT01753856|3030855|Superiority or Other||||||<|0.001||||||DL and Imputed SL, in EC.|Wilcoxon (Mann-Whitney)||||
1647738|NCT01753856|3030855|Superiority or Other||||||<|0.001||||||DL Only, in EC.|Wilcoxon (Mann-Whitney)||||
1647739|NCT01753856|3030855|Superiority or Other||||||<|0.001||||||DL and Imputed SL, in CC.|Wilcoxon (Mann-Whitney)||||
1647740|NCT01753856|3030855|Superiority or Other||||||<|0.001||||||DL Only, in CC.|Wilcoxon (Mann-Whitney)||||
1647741|NCT01753856|3030856|Superiority or Other||||||<|0.001||||||6 months.|Wilcoxon (Mann-Whitney)||||
1647742|NCT01753856|3030856|Superiority or Other||||||<|0.001||||||3 months.|Wilcoxon (Mann-Whitney)||||
1647743|NCT01753856|3030856|Superiority or Other||||||<|0.001||||||1 month.|Wilcoxon (Mann-Whitney)||||
1647744|NCT01753856|3030857|Superiority or Other||||||<|0.001||||||6 months.|Wilcoxon (Mann-Whitney)||||
1647745|NCT01753856|3030857|Superiority or Other||||||<|0.001||||||3 months.|Wilcoxon (Mann-Whitney)||||
1647746|NCT01753856|3030857|Superiority or Other||||||<|0.001||||||1 month.|Wilcoxon (Mann-Whitney)||||
1647747|NCT01753856|3030858|Superiority or Other||||||<|0.001||||||6 months.|Wilcoxon (Mann-Whitney)||||
1647748|NCT01753856|3030858|Superiority or Other||||||<|0.001||||||3 months.|Wilcoxon (Mann-Whitney)||||
1647749|NCT01753856|3030858|Superiority or Other||||||<|0.001||||||1 month.|Wilcoxon (Mann-Whitney)||||
1647750|NCT01753856|3030859|Superiority or Other||||||<|0.001||||||6 months.|Wilcoxon (Mann-Whitney)||||
1647751|NCT01753856|3030859|Superiority or Other||||||<|0.001||||||3 months.|Wilcoxon (Mann-Whitney)||||
1647752|NCT01753856|3030859|Superiority or Other||||||<|0.001||||||1 month.|Wilcoxon (Mann-Whitney)||||
1647753|NCT01753856|3030860|Superiority or Other|||||||0.028||||||dLS/BS, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647754|NCT01753856|3030860|Superiority or Other||||||<|0.001||||||sLS/BS, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647755|NCT01753856|3030860|Superiority or Other||||||<|0.001||||||dLS/BS, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647756|NCT01753856|3030860|Superiority or Other||||||<|0.001||||||sLS/BS, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647757|NCT01753856|3030860|Superiority or Other||||||<|0.001||||||dLS/BS, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647759|NCT01753856|3030860|Superiority or Other||||||<|0.001||||||dLS/BS, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647760|NCT01753856|3030860|Superiority or Other||||||<|0.001||||||sLS/BS, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647761|NCT01753856|3030861|Superiority or Other||||||<|0.001||||||DL and Imputed SL, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647762|NCT01753856|3030861|Superiority or Other||||||<|0.001||||||DL Only, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647763|NCT01753856|3030861|Superiority or Other||||||<|0.001||||||DL and Imputed SL, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647764|NCT01753856|3030861|Superiority or Other||||||<|0.001||||||DL Only, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647765|NCT01753856|3030861|Superiority or Other||||||<|0.001||||||DL and Imputed SL, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647766|NCT01753856|3030861|Superiority or Other||||||<|0.001||||||DL Only, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647767|NCT01753856|3030861|Superiority or Other||||||<|0.001||||||DL and Imputed SL, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647768|NCT01753856|3030861|Superiority or Other||||||<|0.001||||||DL Only, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647769|NCT01753856|3030862|Superiority or Other|||||||0.549||||||DL and Imputed SL, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647770|NCT01753856|3030862|Superiority or Other|||||||0.931||||||DL Only, in PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647771|NCT01753856|3030862|Superiority or Other||||||<|0.001||||||DL and Imputed SL, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647772|NCT01753856|3030862|Superiority or Other||||||<|0.001||||||DL Only, in IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647773|NCT01753856|3030862|Superiority or Other||||||<|0.001||||||DL and Imputed SL, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647774|NCT01753856|3030862|Superiority or Other||||||<|0.001||||||DL Only, in EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647775|NCT01753856|3030862|Superiority or Other||||||<|0.001||||||DL and Imputed SL, in the CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647776|NCT01753856|3030862|Superiority or Other||||||<|0.004||||||DL Only, in CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647777|NCT01753856|3030863|Superiority or Other|||||||0.85||||||PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647778|NCT01753856|3030863|Superiority or Other||||||<|0.001||||||IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647779|NCT01753856|3030863|Superiority or Other||||||<|0.004||||||EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647780|NCT01753856|3030863|Superiority or Other||||||<|0.001||||||CC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline as a covariate.|||
1647781|NCT01753856|3030864|Superiority or Other|||||||0.74||||||PC.|Wilcoxon (Mann-Whitney)||||
1647782|NCT01753856|3030864|Superiority or Other||||||<|0.001||||||EC.|Wilcoxon (Mann-Whitney)||||
1647783|NCT01753856|3030864|Superiority or Other||||||<|0.001||||||CC.|Wilcoxon (Mann-Whitney)||||
1647784|NCT01753856|3030866|Superiority or Other|||||||0.661||||||Modeling-Based Bone Formation in the PC.|Wilcoxon (Mann-Whitney)||||
1647785|NCT01753856|3030866|Superiority or Other|||||||0.661||||||Remodeling-Based Bone Formation in the PC.|Wilcoxon (Mann-Whitney)||||
1647786|NCT01753856|3030866|Superiority or Other|||||||0.008||||||Modeling-Based Bone Formation in the EC.|Wilcoxon (Mann-Whitney)||||
1647787|NCT01753856|3030866|Superiority or Other|||||||0.008||||||Remodeling-Based Bone Formation in the EC.|Wilcoxon (Mann-Whitney)||||
1647788|NCT01753856|3030866|Superiority or Other|||||||0.74||||||Modeling-Based Bone Formation in the CC.|Wilcoxon (Mann-Whitney)||||
1647789|NCT01753856|3030866|Superiority or Other|||||||0.74||||||Remodeling-Based Bone Formation in the CC.|Wilcoxon (Mann-Whitney)||||
1647790|NCT01753856|3030867|Superiority or Other||||||<|0.001||||||PC.|Wilcoxon (Mann-Whitney)||||
1647791|NCT01753856|3030867|Superiority or Other||||||<|0.001||||||IC.|Wilcoxon (Mann-Whitney)||||
1647792|NCT01753856|3030867|Superiority or Other||||||<|0.001||||||EC.|Wilcoxon (Mann-Whitney)||||
1647793|NCT01753856|3030867|Superiority or Other||||||<|0.001||||||CC.|Wilcoxon (Mann-Whitney)||||
1647794|NCT01753856|3030868|Superiority or Other||||||<|0.001||||||PC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.|||
1647795|NCT01753856|3030868|Superiority or Other||||||<|0.001||||||IC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.|||
1647796|NCT01753856|3030868|Superiority or Other||||||<|0.001||||||EC.|ANCOVA|ANCOVA model with treatment group as the main effect and baseline MS/BS as a covariate.|||
1647797|NCT01753856|3030869|Superiority or Other||||||<|0.001||||||No Label, in PC.|Fisher Exact||||
1647798|NCT01753856|3030869|Superiority or Other||||||<|0.001||||||SL Only, in PC.|Fisher Exact||||
1647799|NCT01753856|3030869|Superiority or Other||||||<|0.002||||||DL and SL, in PC.|Fisher Exact||||
1647800|NCT01753856|3030869|Superiority or Other||||||>|0.999||||||No Label, in IC.|Fisher Exact||||
1647801|NCT01753856|3030869|Superiority or Other||||||>|0.001||||||SL Only, in IC.|Fisher Exact||||
1647802|NCT01753856|3030869|Superiority or Other||||||<|0.001||||||DL and SL, in IC.|Fisher Exact||||
1647803|NCT01753856|3030869|Superiority or Other||||||<|0.118||||||No Label, in EC.|Fisher Exact||||
1647804|NCT01753856|3030869|Superiority or Other||||||<|0.027||||||SL Only, in EC.|Fisher Exact||||
1647809|NCT01753856|3030870|Superiority or Other||||||<|0.001|||||||ANCOVA|Analysis of covariance (ANCOVA) model with treatment group as the main effect and baseline MS/BS as a covariate.|||
1647810|NCT01753518|3030890|Superiority or Other|||||||0.97|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: overall opinion.|
1647811|NCT01753518|3030890|Superiority or Other|||||||0.76|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: surface area.|
1647812|NCT01753518|3030890|Superiority or Other|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: pliability.|
1647813|NCT01753518|3030890|Superiority or Other|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: relief.|
1647814|NCT01753518|3030890|Superiority or Other|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: thickness|
1647815|NCT01753518|3030890|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: pigmentation.|
1647816|NCT01753518|3030890|Superiority or Other|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for observer: vascularity.|
1647817|NCT01753518|3030890|Superiority or Other|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: overall opinion.|
1647818|NCT01753518|3030890|Superiority or Other|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar more irregular.|
1647819|NCT01753518|3030890|Superiority or Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar thickness is different.|
1647820|NCT01753518|3030890|Superiority or Other|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar stiffness is different.|
1647821|NCT01753518|3030890|Superiority or Other|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar color is different.|
1647822|NCT01753518|3030890|Superiority or Other|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar itching.|
1647823|NCT01753518|3030890|Superiority or Other|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for patient: scar painful.|
1647824|NCT01753518|3030891|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1647825|NCT01753518|3030892|Superiority or Other||||||<|0.001|||||||Chi-squared|||"Comparison between arms for willingness to use treatment again."|
1647826|NCT01753518|3030892|Superiority or Other||||||<|0.004|||||||Chi-squared|||"Comparison between arms for recommend treatment."|
1647827|NCT01753518|3030892|Superiority or Other||||||<|0.85|||||||Chi-squared|||"Comparison between arms for appearance of incision."|
1647828|NCT01753518|3030893|Superiority or Other|||||||0.41|||||||Fisher Exact|||"Comparison of negative responses to Overall satisfaction question."|
1647829|NCT01753518|3030893|Superiority or Other|||||||0.57|||||||Chi-squared|||"Comparison of negative responses to Willingness to use treatment again question."|
1647830|NCT01753518|3030893|Superiority or Other|||||||0.098|||||||Chi-squared|||"Comparison for negative responses to Would recommend treatment to friends question."|
1647831|NCT01753518|3030893|Superiority or Other|||||||0.51|||||||Fisher Exact|||"Comparison for negative responses to Appearance of incision question."|
1647832|NCT01753518|3030895|Superiority or Other|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Oxycodone use.|
1647833|NCT01753518|3030895|Superiority or Other|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Toradol use.|
1647834|NCT01753518|3030895|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Ibuprofen use.|
1647835|NCT01753518|3030895|Superiority or Other|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for Tylenol use.|
1647836|NCT01753518|3030896|Superiority or Other|||||||0.5|||||||Fisher Exact|||Comparison for Hematoma|
1647837|NCT01753518|3030896|Superiority or Other|||||||0.49|||||||Fisher Exact|||Comparison for Seroma|
1647838|NCT01753518|3030896|Superiority or Other|||||||0.21|||||||Fisher Exact|||Comparison for Superficial Wound Separation|
1647839|NCT01753518|3030896|Superiority or Other|||||||0.06|||||||Fisher Exact|||Comparison for Surgical Site Infection|
1647840|NCT01753518|3030896|Superiority or Other|||||||0.25|||||||Fisher Exact|||Comparison for staple expulsion or suture trimming|
1647841|NCT01753518|3030897|Superiority or Other|||||||0.73|||||||Chi-squared||||
1647842|NCT01753518|3030898|Superiority or Other|||||||0.053|||||||Wilcoxon (Mann-Whitney)||||
1647843|NCT01753336|3030922|Superiority or Other||Mean Difference (Net)|-0.1|Standard Deviation|3.78|||2-Sided|95.0|-0.85|0.73||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.|
1647844|NCT01753336|3030922|Superiority or Other||Mean Difference (Net)|-0.7|Standard Deviation|4.2|||2-Sided|95.0|-1.57|0.19||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.|
1647845|NCT01753336|3030922|Superiority or Other||Mean Difference (Net)|-0.5|Standard Deviation|3.04|||2-Sided|95.0|-1.08|0.18||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.|
1647846|NCT01753336|3030922|Superiority or Other||Mean Difference (Net)|-1.2|Standard Deviation|3.12|||2-Sided|95.0|-1.84|-0.58||||||Cycle 2-Day 1 vs Cycle 2-Week 4.The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.|
1647847|NCT01753336|3030922|Superiority or Other||Mean Difference (Net)|-1.4|Standard Deviation|3.88|||2-Sided|95.0|-2.22|-0.66||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.|
1647848|NCT01753336|3030922|Superiority or Other||Mean Difference (Net)|-1.7|Standard Deviation|3.74|||2-Sided|95.0|-2.39|-0.92||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.|
1647963|NCT01751646|3031269|Other|||||||0.1378|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)|
1647849|NCT01753336|3030923|Superiority or Other||Mean Difference (Net)|-0.1|Standard Deviation|3.73|||2-Sided|95.0|-0.85|0.7||||||Cycle 3-Day 1 vs Cycle 3-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.|
1647850|NCT01753336|3030923|Superiority or Other||Mean Difference (Net)|-0.7|Standard Deviation|3.75|||2-Sided|95.0|-1.45|0.12||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.|
1647851|NCT01753336|3030923|Superiority or Other||Mean Difference (Net)|-0.8|Standard Deviation|3.46|||2-Sided|95.0|-1.55|-0.12||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.|
1647852|NCT01753336|3030923|Superiority or Other||Mean Difference (Net)|-1.7|Standard Deviation|3.47|||2-Sided|95.0|-2.44|-1.04||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.|
1647853|NCT01753336|3030923|Superiority or Other||Mean Difference (Net)|-1.8|Standard Deviation|4.82|||2-Sided|95.0|-2.79|-0.86||||||Cycle 1-Day 1 vs Cycle 1-Week 12.The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.|
1647854|NCT01753336|3030923|Superiority or Other||Mean Difference (Net)|-2.9|Standard Deviation|3.86|||2-Sided|95.0|-3.64|-2.12||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.|
1647855|NCT01753336|3030924|Superiority or Other||Mean Difference (Net)|-1.0|Standard Deviation|4.77|||2-Sided|95.0|-2.0|-0.02||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.|
1647856|NCT01753336|3030924|Superiority or Other||Mean Difference (Net)|-2.7|Standard Deviation|4.32|||2-Sided|95.0|-3.64|-1.83||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.|
1647857|NCT01753336|3030924|Superiority or Other||Mean Difference (Net)|-0.5|Standard Deviation|3.86|||2-Sided|95.0|-1.33|0.27||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 was determined.|
1647858|NCT01753336|3030924|Superiority or Other||Mean Difference (Net)|-3.0|Standard Deviation|3.77|||2-Sided|95.0|-3.75|-2.23||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 was determined.|
1647859|NCT01753336|3030924|Superiority or Other||Mean Difference (Net)|-1.8|Standard Deviation|5.24|||2-Sided|95.0|-2.81|-0.7||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 was determined.|
1647860|NCT01753336|3030924|Superiority or Other||Mean Difference (Net)|-3.5|Standard Deviation|4.95|||2-Sided|95.0|-4.46|-2.52||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS severity subscale scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 was determined.|
1647861|NCT01753336|3030926|Superiority or Other||Mean Difference (Net)|-11.7|Standard Deviation|11.17|||2-Sided|95.0|-14.02|-9.39||||||Pretreatment baseline vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 3 is presented.|
1647862|NCT01753336|3030926|Superiority or Other||Mean Difference (Net)|-14.6|Standard Deviation|12.19|||2-Sided|95.0|-17.18|-12.1||||||Pretreatment baseline vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 3 is presented.|
1647863|NCT01753336|3030926|Superiority or Other||Mean Difference (Net)|-10.6|Standard Deviation|11.33|||2-Sided|95.0|-12.92|-8.22||||||Pretreatment baseline vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for Treatment Cycle 2 is presented.|
1647864|NCT01753336|3030926|Superiority or Other||Mean Difference (Net)|-14.4|Standard Deviation|11.43|||2-Sided|95.0|-16.74|-12.11||||||Pretreatment baseline vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 2 is presented.|
1647865|NCT01753336|3030926|Superiority or Other||Mean Difference (Net)|-8.9|Standard Deviation|10.89|||2-Sided|95.0|-11.08|-6.71||||||Pretreatment baseline vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 12 visit for treatment Cycle 1 is presented.|
1647866|NCT01753336|3030926|Superiority or Other||Mean Difference (Net)|-11.5|Standard Deviation|9.74|||2-Sided|95.0|-13.38|-9.56||||||Pretreatment baseline vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from baseline (pretreatment measurement before receiving Dysport® in Study 169 or for subjects who received placebo in Study 169, baseline was Day 1 of Cycle 1 of Study 170) at the Week 4 visit for Treatment Cycle 1 is presented.|
1647867|NCT01753336|3030927|Superiority or Other||Mean Difference (Net)|-1.1|Standard Deviation|9.42|||2-Sided|95.0|-3.11|0.81||||||Cycle 3-Day 1 vs Cycle 3-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 3 was determined.|
1647868|NCT01753336|3030927|Superiority or Other||Mean Difference (Net)|-4.1|Standard Deviation|9.03|||2-Sided|95.0|-5.99|-2.2||||||Cycle 3-Day 1 vs Cycle 3-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 3 was determined.|
1649228|NCT01728454|3033789|Superiority|||||||0.4365|||||||Wilcoxon Rank- Sum Test|||PTS: LOCF Cycle 1|
1647869|NCT01753336|3030927|Superiority or Other||Mean Difference (Net)|-1.8|Standard Deviation|7.49|||2-Sided|95.0|-3.37|-0.27||||||Cycle 2-Day 1 vs Cycle 2-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 2 is presented.|
1647870|NCT01753336|3030927|Superiority or Other||Mean Difference (Net)|-5.9|Standard Deviation|7.29|||2-Sided|95.0|-7.42|-4.47||||||Cycle 2-Day 1 vs Cycle 2-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 2 is presented.|
1647871|NCT01753336|3030927|Superiority or Other||Mean Difference (Net)|-5.0|Standard Deviation|11.68|||2-Sided|95.0|-7.36|-2.68||||||Cycle 1-Day 1 vs Cycle 1-Week 12. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 12 visit for Treatment Cycle 1 is presented.|
1647872|NCT01753336|3030927|Superiority or Other||Mean Difference (Net)|-8.0|Standard Deviation|8.94|||2-Sided|95.0|-9.79|-6.28||||||Cycle 1-Day 1 vs Cycle 1-Week 4. The mean difference in the TWSTRS total scores from treatment cycle baseline (Day 1) at the Week 4 visit for Treatment Cycle 1 is presented.|
1647873|NCT01753310|3030948|Superiority or Other||||||=|0|||||||ANOVA|||The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.|
1647874|NCT01753310|3030949|Superiority or Other||||||=|0|||||||ANOVA|||The superiority of Dysport® to placebo on CDIP-58 was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.|
1647875|NCT01753310|3030950|Superiority or Other||||||<|0.001|||||||Mantel-Haenszel chi-squared test|||The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.|
1647876|NCT01753310|3030951|Superiority or Other||||||<|0.001|||||||ANOVA|||The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an ANOVA with treatment and randomisation stratification factor as main effects.|
1647877|NCT01753310|3030952|Superiority or Other||||||=|0|||||||Mantel-Haenszel chi-squared test|||The superiorty of Dysport® to placebo on treatment response was tested at a two-tailed 5% level by using a Mantel-Haenszel chi-squared test stratified by the randomisation factor.|
1647878|NCT01753310|3030953|Superiority or Other||||||<|0.001|||||||ANOVA|||The superiority of Dysport® to placebo on CGIC of CD was tested at a two-tailed 5% level by using an analysis of variance (ANOVA) with treatment and randomisation stratification factor as main effects.|
1647879|NCT01753310|3030954|Superiority or Other||Mean Difference|-5.4|Standard Error of the Mean|1.65|=|0|2-Sided|95.0|-8.67|-2.14|||t-test, 2 sided|The 2 sided t-test was on weighted overall treatment difference.|Based on the sample size weighted overall treatment difference.|The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified ANCOVA with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).|
1647880|NCT01753310|3030955|Superiority or Other||Mean Difference|-8.3|Standard Error of the Mean|1.95|<|0.001|2-Sided|95.0|-12.17|-4.47|||t-test, 2 sided|The 2 sided t-test was on weighted overall treatment difference.|Based on the sample size weighted overall treatment difference.|The superiority of Dysport® to placebo was tested at a two-tailed 5% level by using a stratified analysis of covariance (ANCOVA) with baseline TWSTRS total score as covariate and stratified by the randomisation stratification factor (BoNT-A naïve versus BoNT-A non-naïve).|
1647881|NCT01753115|3030965|Non-Inferiority or Equivalence|Non-inferiority margin is 0.67.|Ratio of GMT|1.267|||||2-Sided|95.0|0.898|1.787|||||||
1647882|NCT01753115|3030966|Non-Inferiority or Equivalence|Equivalence margin is 0.80 - 1.25.|Ratio of Cmax|0.944|||||2-Sided|90.0|0.852|1.046||||||Analysis of Cmax at Day 5 and Day 44|
1647883|NCT01753115|3030966|Non-Inferiority or Equivalence|Equivalence margin is 0.80 - 1.25.|Ratio of AUC|0.887|||||2-Sided|90.0|0.831|0.948||||||Analysis of Ciprofloxacin Area Under the Curve at Day 5 and Day 44.|
1647884|NCT01753076|3030967|Superiority or Other||Mean Difference (Final Values)|1.4|||||2-Sided|95.0|-2.8|5.5|||||||
1647885|NCT01753076|3030968|Superiority or Other||Mean Difference (Final Values)|-0.004|||||2-Sided|95.0|-0.062|0.053|||||||
1647886|NCT01753076|3030969|Superiority or Other||Hazard Ratio (HR)|1.07||||0.642|2-Sided|95.0|0.81|1.42|||Regression, Cox||||
1647887|NCT01753076|3030970|Superiority or Other||Hazard Ratio (HR)|1.03||||0.923|2-Sided|95.0|0.53|2.01|||Chi-squared||Week 60||
1647888|NCT01753076|3030970|Superiority or Other||Hazard Ratio (HR)|0.99||||0.986|2-Sided|95.0|0.34|2.89|||Regression, Cox||Week 48||
1647889|NCT01753076|3030971|Superiority or Other||Odds Ratio (OR)|0.73||||0.393|2-Sided|95.0|0.36|1.49|||Regression, Logistic||||
1647890|NCT01753076|3030972|Superiority or Other||Mean Difference (Final Values)|-8.2||||0.125|2-Sided|95.0|-18.7|2.3|||Mixed Models Analysis||||
1647891|NCT01753076|3030973|Superiority or Other||Mean Difference (Final Values)|-0.127||||0.265|2-Sided|95.0|-0.351|0.097|||Mixed Models Analysis||||
1647892|NCT01753076|3030974|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.173|2-Sided|95.0|-0.3|0.05|||Random coefficients analysis||||
1647893|NCT01753076|3030975|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.139|2-Sided|95.0|-3.1|0.4|||Mixed Models Analysis||||
1647894|NCT01753076|3030976|Superiority or Other||Mean Difference (Final Values)|-30.0||||0.12|2-Sided|95.0|-67.9|7.9|||ANCOVA||A negative mean difference means that the direction of effect is in favor of placebo.||
1647895|NCT01752907|3030996|Superiority or Other||Treatment Difference|0.3|Standard Error of the Mean|0.4||0.3479|2-Sided|95.0|-0.4|1.0|||t-test, 2 sided||Treatment difference = bone pain DVD - general education DVD|There was no statistical hypothesis testing for this study. The clinical hypothesis was that a difference in mean maximum pain of 0.5 (scale 0 to 10) in favor of bone pain education would be a clinically relevant difference.|
1647964|NCT01751646|3031272|Other|||||||0.8383|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)|
1647965|NCT01751646|3031274|Other|||||||0.1166||||||P-value from Wilcoxon rank sum test for change between baseline and Week 48 Vitamin D vs. Placebo|Wilcoxon (Mann-Whitney)||||
1647992|NCT01751113|3031335|Superiority or Other||specific airway conductance ratio|0.803|||<|0.001|2-Sided|95.0|0.741|0.869|||Mixed Models Analysis||||
1647896|NCT01752842|3031002|Superiority|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|-1.79||||0.0034|2-Sided|95.0|-2.93|-0.65||This P-value is based on ANCOVA.|ANCOVA|ANCOVA was used to compare mean change of outcome adjusting for body fat percent, demographic variables and baseline biomarkers.||Null hypothesis is no difference of mean change of C24:0/C16:0 ceramide ratio between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.
1647897|NCT01752842|3031003|Superiority|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|0.0058||||0.8128|2-Sided|95.0|-0.0418|0.0543||This P-value is based on ANCOVA.|ANCOVA||ANCOVA was used to compare mean change of outcome adjusting for body fat percent, demographic variables and baseline biomarkers.|Null hypothesis is no difference of mean change of fractional shortening percent between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.
1647898|NCT01752842|3031004|Superiority|Power calculation is based on assumption that treatment with Fenofibrate will lead to 11% decrease in plasma TG and ceramide biomarkers. We also assume that there will be no significant change in ceramides without intervention. Based on these assumptions, 86 subjects are required to have 90% chance of detecting a decrease in the primary outcome measure from 1.29 in the placebo group to 1.15 in the Fenofibrate group.|Mean Difference (Final Values)|-0.75||||0.07|2-Sided|95.0|-1.56|0.04||This P-value is based on ANCOVA.|ANCOVA||ANCOVA was used to compare mean change of cardiac diastolic function adjusting for body fat percent, baseline values of BMI, diastolic/systolic blood pressure, HbA1c, fasting glucose, triglycerides, ethnicity, gender and race.|Null hypothesis is no difference of mean change of cardiac diastolic function as measured by E' (cm/s) between placebo and Fenofibrate.|Two-sample t-test was used to compare baseline mean values of biomarkers. All statistical tests are two-sided at significance level 0.05.
1647899|NCT01752634|3031011|Superiority||Odds Ratio (OR)|0.29||||0.0025|2-Sided|95.0|0.13|0.65|||Regression, Logistic||||
1647900|NCT01752634|3031011|Superiority||Odds Ratio (OR)|0.36||||0.0108|2-Sided|95.0|0.17|0.79|||Regression, Logistic||||
1647901|NCT01752634|3031011|Superiority||Odds Ratio (OR)|0.58||||0.1678|2-Sided|95.0|0.26|1.26|||Regression, Logistic||||
1647902|NCT01752634|3031012|Superiority||Odds Ratio (OR)|0.14||||0.0021|2-Sided|95.0|0.04|0.5|||Regression, Logistic||||
1647903|NCT01752634|3031012|Superiority||Odds Ratio (OR)|0.16||||0.0056|2-Sided|95.0|0.04|0.58|||Regression, Logistic||||
1647904|NCT01752634|3031012|Superiority||Odds Ratio (OR)|0.51||||0.3149|2-Sided|95.0|0.13|1.91|||Regression, Logistic||||
1647905|NCT01752634|3031013|Superiority||Odds Ratio (OR)|7.15|||<|0.0001|2-Sided|95.0|2.97|17.22|||Regression, Logistic||||
1647906|NCT01752634|3031013|Superiority||Odds Ratio (OR)|7.54|||<|0.0001|2-Sided|95.0|3.11|18.25|||Regression, Logistic||||
1647907|NCT01752634|3031013|Superiority||Odds Ratio (OR)|2.91|||<|0.0245|2-Sided|95.0|1.15|7.36|||Regression, Logistic||||
1647908|NCT01752634|3031014|Superiority||Mean Difference (Net)|-0.25||||0.0013|2-Sided|95.0|-0.4|-0.1|||Mixed Models Analysis||||
1647909|NCT01752634|3031014|Superiority||Mean Difference (Net)|-0.17||||0.0278|2-Sided|95.0|-0.32|-0.02|||Mixed Models Analysis||||
1647910|NCT01752634|3031014|Superiority||Mean Difference (Net)|-0.01||||0.9195|2-Sided|95.0|-0.16|0.15|||Mixed Models Analysis||||
1647911|NCT01752634|3031015|Superiority||Mean Difference (Net)|5.3|||<|0.0001|2-Sided|95.0|2.91|7.69|||Mixed Models Analysis||||
1647912|NCT01752634|3031015|Superiority||Mean Difference (Net)|4.44|||<|0.0003|2-Sided|95.0|2.05|6.83|||Mixed Models Analysis||||
1647913|NCT01752634|3031015|Superiority||Mean Difference (Net)|2.42|||<|0.0482|2-Sided|95.0|0.02|4.83|||Mixed Models Analysis||||
1647914|NCT01752634|3031016|Superiority||Mean Difference (Net)|-0.65||||0.0004|2-Sided|95.0|-1.02|-0.29|||Mixed Models Analysis||||
1647915|NCT01752634|3031016|Superiority||Mean Difference (Net)|-0.62||||0.0008|2-Sided|95.0|-0.98|-0.26|||Mixed Models Analysis||||
1647916|NCT01752634|3031016|Superiority||Mean Difference (Net)|-0.16||||0.3763|2-Sided|95.0|-0.53|0.2|||Mixed Models Analysis||||
1647917|NCT01752634|3031017|Superiority||Odds Ratio (OR)|10.74||||0.0002|2-Sided|95.0|3.13|36.84|||Regression, Logistic||||
1647918|NCT01752634|3031017|Superiority||Odds Ratio (OR)|6.36||||0.0029|2-Sided|95.0|1.89|21.47|||Regression, Logistic||||
1647919|NCT01752634|3031017|Superiority||Odds Ratio (OR)|1.38||||0.6421|2-Sided|95.0|0.36|5.36|||Regression, Logistic||||
1647920|NCT01752634|3031018|Superiority||Odds Ratio (OR)|9.48|||<|0.0001|2-Sided|95.0|3.33|27.0|||Regression, Logistic||||
1647921|NCT01752634|3031018|Superiority||Odds Ratio (OR)|5.7|||<|0.0006|2-Sided|95.0|2.12|15.34|||Regression, Logistic||||
1647922|NCT01752634|3031018|Superiority||Odds Ratio (OR)|2.07|||<|0.165|2-Sided|95.0|0.74|5.81|||Regression, Logistic||||
1647923|NCT01752634|3031019|Superiority||Odds Ratio (OR)|6.81|||<|0.0001|2-Sided|95.0|3.42|13.56|||Regression, Logistic||||
1647924|NCT01752634|3031019|Superiority||Odds Ratio (OR)|6.52|||<|1|2-Sided|95.0|3.25|13.08|||Regression, Logistic||||
1647925|NCT01752634|3031019|Superiority||Odds Ratio (OR)|2.32|||<|0.02|2-Sided|95.0|1.14|4.73|||Regression, Logistic||||
1647966|NCT01751178|3031300|Superiority or Other||Adjusted Mean Difference|-0.97|||<|0.0001|2-Sided|95.0|-1.16|-0.78||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypotheses stated that there was no difference between the two groups.|
1647926|NCT01751971|3031041|Superiority||Mean Difference (Net)|42.8||||0.001|2-Sided|95.0|21.0|64.6|||t-test, 2 sided||Direction of comparison: Positive estimated value would indicate a greater percentage reduction in AHI (oxygen vs. sham) in favorable vs. unfavorable subgroups.|"The primary goal of the study was to identify a phenotypic subgroup of patients with sleep apnea that responds preferentially to oxygen (percent reduction in AHI----[AHI(sham)-AHI(oxygen)]/AHI(sham) %). We defined patient subgroups (favorable versus unfavorable) based on the four key phenotypic traits (loop gain, collapsibility, arousal threshold, muscle responses) measured on the sham night, with the use of multiple logistic regression and leave-one-out cross validation."|
1647927|NCT01751971|3031041|Superiority||Mean Difference (Final Values)|17.4|Standard Error of the Mean|3.3|<|0.001|2-Sided|95.0|10.7|24.1|||t-test, 2 sided||Direction of comparison: Positive estimation parameter would indicate lower AHI on oxygen versus sham.|Here we aimed to confirm that there was a difference between AHI on oxygen vs sham (overall, i.e. in unselected patients). This test, however was not part of our primary objective.|
1647928|NCT01751971|3031041|Superiority||Mean Difference (Net)|10.5|||<|0.4|2-Sided|95.0|-16.0|37.1|||t-test, 2 sided||Positive estimated value would represent a greater reduction in AHI with oxygen (% sham) in the high vs low loop gain group.|"Primary statistical comparison was the percent reduction in AHI----[AHI(sham)-AHI(oxygen)]/AHI(sham) %----between two phenotypic patient subgroups. Patient subgroups were defined by the loop gain (LG1) measured on the sham night as high or low (a priori cutoff LG1=0.7)."|
1647929|NCT01751906|3031141|Superiority|||||||0.504|||||||Fisher Exact||||
1647930|NCT01751906|3031177|Superiority|||||||0.2126|||||||Fisher Exact||||
1647931|NCT01751906|3031178|Superiority|||||||0.9256|||||||Chi-squared||||
1647932|NCT01751867|3031188|Superiority or Other||ORR %|25.5|||<|0.001|2-Sided|95.0|17.2|35.3|||Exact binomial proportion test|||Null Hypothesis: threshold for statistical significance = 10%|
1647933|NCT01751867|3031188|Superiority or Other||ORR %|29.4|||<|0.003|2-Sided|95.0|15.1|47.5|||Exact binomial proportion test||ORR % = Number of participants who achieved response divided by total ITT participants|Null Hypothesis: threshold for statistical significance = 10%|
1647934|NCT01751646|3031203|Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of Week 48 difference from baseline|
1647935|NCT01751646|3031203|Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of Week 48 difference from baseline|
1647936|NCT01751646|3031206|Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of change from baseline to Week 48|
1647937|NCT01751646|3031206|Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Test of change from baseline to week 48|
1647938|NCT01751646|3031212|Other|||||||0.157|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647939|NCT01751646|3031213|Other|||||||0.581|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647940|NCT01751646|3031214|Other|||||||0.4016|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647941|NCT01751646|3031215|Other|||||||0.9186|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647942|NCT01751646|3031216|Other|||||||0.429|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)|
1647943|NCT01751646|3031219|Other|||||||0.387|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647944|NCT01751646|3031222|Other|||||||0.4808|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647945|NCT01751646|3031225|Other|||||||0.0814|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647946|NCT01751646|3031228|Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647947|NCT01751646|3031231|Other|||||||0.0144|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647948|NCT01751646|3031234|Other|||||||0.021|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647949|NCT01751646|3031237|Other|||||||0.4676|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647950|NCT01751646|3031240|Other|||||||0.7127|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647951|NCT01751646|3031243|Other|||||||0.195|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647952|NCT01751646|3031246|Other|||||||0.7825|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647953|NCT01751646|3031249|Other|||||||0.3728|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647954|NCT01751646|3031252|Other|||||||0.2648|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D3) vs. Group B (Placebo)|
1647955|NCT01751646|3031255|Other|||||||0.2348|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)|
1647956|NCT01751646|3031256|Other|||||||0.6499|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)|
1647957|NCT01751646|3031257|Other|||||||0.255|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)|
1647958|NCT01751646|3031258|Other|||||||0.5098|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)|
1647959|NCT01751646|3031261|Other|||||||0.1187|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)|
1647960|NCT01751646|3031263|Other|||||||0.3978|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)|
1647961|NCT01751646|3031265|Other|||||||0.7601|||||||Wilcoxon (Mann-Whitney)|||Test for change between baseline and Week 48 Group A (Vitamin D) vs. Group B (Placebo)|
1647967|NCT01751178|3031300|Superiority or Other||Adjusted Mean Difference|-0.88|||<|0.0001|2-Sided|95.0|-1.07|-0.69||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypotheses stated that there was no difference between the two treatments.|
1647968|NCT01751178|3031301|Superiority or Other||Adusted Mean Difference|-0.86|||<|0.0001|2-Sided|95.0|-1.04|-0.68||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque Scores.|
1647969|NCT01751178|3031301|Superiority or Other||Adjusted Mean Difference|-0.8|||<|0.0001|2-Sided|95.0|-0.98|-0.62||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque scores.|
1647970|NCT01751178|3031302|Superiority or Other||Adjusted Mean Difference|-0.08|||<|0.0001|2-Sided|95.0|-0.11|-0.06||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups.|
1647971|NCT01751178|3031302|Superiority or Other||Adjusted Mean Difference|-0.08|||<|0.0001|2-Sided|95.0|-0.1|-0.05||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis that there was no difference between the two treatment groups.|
1647972|NCT01751178|3031303|Superiority or Other||Adjusted Mean Difference|-0.07|||<|0.0001|2-Sided|95.0|-0.09|-0.05||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GSI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two treatment groups.|
1647973|NCT01751178|3031303|Superiority or Other||Adjusted Mean Difference|-0.061|||<|0.0001|2-Sided|95.0|-0.081|-0.041||From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GSI as a covariate.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis stated that there was no difference between the two groups.|
1647974|NCT01751165|3031314|Non-Inferiority or Equivalence|Non-nferiority criteria: The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,6-month schedule) at one month post-dose 2 had to be below 1.5.|Adjusted GMC ratio|1.19|||||2-Sided|97.5|0.93|1.53||||||To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,12-month schedule compared to a 0,2-month schedule.|
1647975|NCT01751165|3031314|Non-Inferiority or Equivalence|Non-nferiority criteria: The upper limit (UL) of the 97.5% confidence interval (CI) for the anti-gE ELISA geometric mean concentration (GMC) ratio (0,2-month schedule over 0,6-month schedule) at one month post-dose 2 had to be below 1.5.|Adjusted GMC ratio|1.16|||||2-Sided|97.5|0.98|1.39||||||To demonstrate the non-inferiority in terms of anti-gE humoral immune response one month post-dose 2 given according to a 0,6-month schedule compared to a 0,2-month schedule.|
1647976|NCT01751113|3031332|Superiority or Other||FEV1/FVC ratio|0.008||||0.223|2-Sided|95.0|-0.005|0.021|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio||
1647977|NCT01751113|3031332|Superiority or Other||FEV1/FVC ratio|0.027|||<|0.001|2-Sided|95.0|0.014|0.041|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio||
1647978|NCT01751113|3031333|Superiority or Other||Mean difference of TGV|-0.091||||0.083|2-Sided|95.0|-0.195|0.012|||Mixed Models Analysis||Statistical data for TGV||
1647979|NCT01751113|3031333|Superiority or Other||Mean difference of TGV|-0.092||||0.085|2-Sided|95.0|-0.197|0.013|||Mixed Models Analysis||Statistical data for TGV||
1647980|NCT01751113|3031333|Superiority or Other||Mean difference of TLC|-0.105||||0.044|2-Sided|95.0|-0.206|-0.003|||Mixed Models Analysis||Statistical data for TLC||
1647981|NCT01751113|3031333|Superiority or Other||Mean difference of TLC|-0.101||||0.055|2-Sided|95.0|-0.204|0.002|||Mixed Models Analysis||Statistical data for TLC||
1647982|NCT01751113|3031333|Superiority or Other||Mean difference of RV|-0.189||||0.003|2-Sided|95.0|-0.314|-0.064|||Mixed Models Analysis||Statistical data for RV||
1647983|NCT01751113|3031333|Superiority or Other||Mean difference of RV|-0.229|||<|0.001|2-Sided|95.0|-0.355|-0.103|||Mixed Models Analysis||Statistical data for RV||
1647984|NCT01751113|3031333|Superiority or Other||Mean difference of IC|-0.008|||<|0.89|2-Sided|95.0|-0.118|0.103|||Mixed Models Analysis||Statistical data for IC||
1647985|NCT01751113|3031333|Superiority or Other||Mean difference of IC|-0.008|||<|0.89|2-Sided|95.0|-0.12|0.104|||Mixed Models Analysis||Statistical data for IC||
1647986|NCT01751113|3031333|Superiority or Other||Mean difference of FVC|0.148|||<|0.006|2-Sided|95.0|0.043|0.253|||Mixed Models Analysis||Statistical data for FVC||
1647987|NCT01751113|3031333|Superiority or Other||Mean difference of FVC|0.104|||<|0.051|2-Sided|95.0|0.0|0.209|||Mixed Models Analysis||Statistical data for FVC||
1647988|NCT01751113|3031333|Superiority or Other||Mean difference of FEV1|0.103|||<|0.008|2-Sided|95.0|0.028|0.178|||Mixed Models Analysis||Statistical data for FEV1||
1647989|NCT01751113|3031333|Superiority or Other||Mean difference of FEV1|0.161|||<|0.001|2-Sided|95.0|0.086|0.236|||Mixed Models Analysis||Statistical data for FEV1||
1647990|NCT01751113|3031334|Superiority or Other||specific airway conductance ratio|1.249|||<|0.001|2-Sided|95.0|1.153|1.352|||Mixed Models Analysis||||
1647991|NCT01751113|3031334|Superiority or Other||specific airway conductance ratio|1.2|||<|0.001|2-Sided|95.0|1.108|1.301|||Mixed Models Analysis||||
1648031|NCT01751061|3031354|Superiority||||||<|0.05||||||P values were calculated.|generalized linear models||||
1647993|NCT01751113|3031335|Superiority or Other||specific airway conductance ratio|0.835|||<|0.001|2-Sided|95.0|0.77|0.905|||Mixed Models Analysis||||
1647994|NCT01751113|3031336|Superiority or Other||FEV1/FVC ratio|0.017|||<|0.001|2-Sided|95.0|0.008|0.026|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio||
1647995|NCT01751113|3031336|Superiority or Other||FEV1/FVC ratio|0.032|||<|0.001|2-Sided|95.0|0.023|0.041|||Mixed Models Analysis||Statistical data for FEV1/FVC ratio||
1647996|NCT01751113|3031337|Superiority or Other||Mean difference of TGV|-0.075||||0.01|2-Sided|95.0|-0.133|-0.018|||Mixed Models Analysis||Statistical data for TGV||
1647997|NCT01751113|3031337|Superiority or Other||Mean difference of TGV|-0.065||||0.028|2-Sided|95.0|-0.123|-0.007|||Mixed Models Analysis||Statistical data for TGV||
1647998|NCT01751113|3031337|Superiority or Other||Mean difference of TLC|-0.014||||0.596|2-Sided|95.0|-0.067|0.038|||Mixed Models Analysis||Statistical data for TLC||
1647999|NCT01751113|3031337|Superiority or Other||Mean difference of TLC|-0.013||||0.632|2-Sided|95.0|-0.066|0.04|||Mixed Models Analysis||Statistical data for TLC||
1648000|NCT01751113|3031337|Superiority or Other||Mean difference of RV|-0.102||||0.012|2-Sided|95.0|-0.18|-0.023|||Mixed Models Analysis||Statistical data for RV||
1648001|NCT01751113|3031337|Superiority or Other||Mean difference of RV|-0.107||||0.009|2-Sided|95.0|-0.187|-0.028|||Mixed Models Analysis||Statistical data for RV||
1648002|NCT01751113|3031337|Superiority or Other||Mean difference of IC|0.064||||0.011|2-Sided|95.0|0.015|0.114|||Mixed Models Analysis||Statistical data for IC||
1648003|NCT01751113|3031337|Superiority or Other||Mean difference of IC|0.054||||0.035|2-Sided|95.0|0.004|0.104|||Mixed Models Analysis||Statistical data for IC||
1648004|NCT01751113|3031337|Superiority or Other||Mean difference of FVC|0.135|||<|0.001|2-Sided|95.0|0.084|0.186|||Mixed Models Analysis||Statistical data for FVC||
1648005|NCT01751113|3031337|Superiority or Other||Mean difference of FVC|0.082|||<|0.002|2-Sided|95.0|0.031|0.133|||Mixed Models Analysis||Statistical data for FVC||
1648006|NCT01751113|3031337|Superiority or Other||Mean difference of FEV1|0.118|||<|0.001|2-Sided|95.0|0.077|0.159|||Mixed Models Analysis||Statistical data for FEV1||
1648007|NCT01751113|3031337|Superiority or Other||Mean difference of FEV1|0.157|||<|0.001|2-Sided|95.0|0.116|0.198|||Mixed Models Analysis||Statistical data for FEV1||
1648008|NCT01751113|3031338|Superiority or Other||specific airway conductance ratio|0.809|||<|0.001|2-Sided|95.0|0.757|0.865|||Mixed Models Analysis||Statistical data for 240 minutes||
1648009|NCT01751113|3031338|Superiority or Other||specific airway conductance ratio|0.877|||<|0.001|2-Sided|95.0|0.82|0.938|||Mixed Models Analysis||Statistical data for 240 minutes||
1648010|NCT01751113|3031338|Superiority or Other||specific airway conductance ratio|0.769|||<|0.001|2-Sided|95.0|0.719|0.822|||Mixed Models Analysis||Statistical data for 120 minutes||
1648011|NCT01751113|3031338|Superiority or Other||specific airway conductance ratio|0.868|||<|0.001|2-Sided|95.0|0.812|0.928|||Mixed Models Analysis||Statistical data for 120 minutes||
1648012|NCT01751113|3031338|Superiority or Other||specific airway conductance ratio|0.746|||<|0.001|2-Sided|95.0|0.698|0.798|||Mixed Models Analysis||Statistical data for 75 minutes||
1648013|NCT01751113|3031338|Superiority or Other||specific airway conductance ratio|0.85|||<|0.001|2-Sided|95.0|0.795|0.909|||Mixed Models Analysis||Statistical data for 75 minutes||
1648014|NCT01751113|3031338|Superiority or Other||specific airway conductance ratio|0.767|||<|0.001|2-Sided|95.0|0.717|0.819|||Mixed Models Analysis||Statistical data for 30 minutes||
1648015|NCT01751113|3031338|Superiority or Other||specific airway conductance ratio|0.846|||<|0.001|2-Sided|95.0|0.792|0.905|||Mixed Models Analysis||Statistical data for 30 minutes||
1648016|NCT01751113|3031339|Superiority or Other||specific airway conductance ratio|1.239|||<|0.001|2-Sided|95.0|1.159|1.325|||Mixed Models Analysis||Statistical data for 240 minutes||
1648017|NCT01751113|3031339|Superiority or Other||specific airway conductance ratio|1.141|||<|0.001|2-Sided|95.0|1.067|1.22|||Mixed Models Analysis||Statistical data for 240 minutes||
1648018|NCT01751113|3031339|Superiority or Other||specific airway conductance ratio|1.301|||<|0.001|2-Sided|95.0|1.217|1.391|||Mixed Models Analysis||Statistical data for 120 minutes||
1648019|NCT01751113|3031339|Superiority or Other||specific airway conductance ratio|1.151|||<|0.001|2-Sided|95.0|1.076|1.231|||Mixed Models Analysis||Statistical data for 120 minutes||
1648020|NCT01751113|3031339|Superiority or Other||specific airway conductance ratio|1.34|||<|0.001|2-Sided|95.0|1.253|1.432|||Mixed Models Analysis||Statistical data for 75 minutes||
1648021|NCT01751113|3031339|Superiority or Other||specific airway conductance ratio|1.175|||<|0.001|2-Sided|95.0|1.099|1.257|||Mixed Models Analysis||Statistical data for 75 minutes||
1648022|NCT01751113|3031339|Superiority or Other||specific airway conductance ratio|1.303|||<|0.001|2-Sided|95.0|1.219|1.393|||Mixed Models Analysis||Statistical data for 30 minutes||
1648023|NCT01751113|3031339|Superiority or Other||specific airway conductance ratio|1.181|||<|0.001|2-Sided|95.0|1.104|1.263|||Mixed Models Analysis||Statistical data for 30 minutes||
1648024|NCT01751113|3031340|Superiority or Other||AUC ratio|0.774|||<|0.001|2-Sided|95.0|0.735|0.816|||Mixed Models Analysis||||
1648025|NCT01751113|3031340|Superiority or Other||AUC ratio|0.856|||<|0.001|2-Sided|95.0|0.812|0.902|||Mixed Models Analysis||||
1648026|NCT01751113|3031341|Superiority or Other||AUC ratio|1.288|||<|0.001|2-Sided|95.0|1.224|1.355|||Mixed Models Analysis||||
1648027|NCT01751113|3031341|Superiority or Other||AUC ratio|1.158|||<|0.001|2-Sided|95.0|1.1|1.219|||Mixed Models Analysis||||
1648028|NCT01751061|3031351|Superiority||||||<|0.05||||||P values were calculated.|GEE|||To test the hypothesis, we used a general linear model fit with generalized estimating equations, a linear link, and an exchangeable correlation (PROC GENMOD). Model parameters included indictor variables for intervention, Interview 2, the interaction between intervention and Interview 2, and a 4-level site variable. The mean CSCS between-groups difference, corresponding 95% confidence interval (CI), and p value were derived from the intervention-by-Interview 2 interaction term.|
1648029|NCT01751061|3031352|Superiority||||||<|0.05||||||P values were calculated.|generalized linear models||||
1648030|NCT01751061|3031353|Superiority||||||<|0.05||||||P values were calculated.|generalized linear models||||
1648033|NCT01751061|3031356|Superiority||||||<|0.05||||||P values were calculated.|generalized linear model|||Generalized linear model.|
1648034|NCT01751061|3031357|Superiority|To test the primary hypothesis, we used a general linear model fit with generalized estimating equations, a linear link, and an exchangeable correlation (PROC GENMOD). Model parameters included indictor variables for intervention, Interview 2, the interaction between intervention and Interview 2, and a 4-level site variable. The mean CSCS between-groups difference, corresponding 95% confidence interval (CI), and p value were derived from the intervention-by-Interview 2 interaction term.|||||<|0.05||||||P values were calculated. A two-sided type-I error rate of 0.05 was set for all tests; there were no adjustments for multiple comparisons. All participants were included in analyses as per their group randomization.|GEE|||We estimated that 210 patients (315 surrogates, assuming ~1.5 per patient) would provide a power of 80% to detect a between-groups mean CSCS score difference of 9 percentage points between Interviews 1 and 2, assuming a baseline mean of 50, SD=24, a type-I error=5%, a correlation between interviews of 0.5, an expectation that 50% of patients would have multiple surrogates, an intraclass correlation coefficient of 0.8 for multiple surrogates for a patient, and 5% dropout before Interview 2.|
1648035|NCT01750931|3031371|Non-Inferiority or Equivalence|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|102.31||||0.9951|2-Sided|95.0|99.05|105.69|||ANOVA||Comparison of AUC0-infinity between group GSK-meloxicam 15 mg and Mobic-meloxicam 15 mg||
1648036|NCT01750931|3031371|Non-Inferiority or Equivalence|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|105.02||||0.9712|2-Sided|95.0|99.69|110.63|||ANOVA||Comparison of AUC0-t between group GSK-meloxicam 15 mg and Mobic-meloxicam 15 mg||
1648037|NCT01750931|3031373|Non-Inferiority or Equivalence|Bioequivalence is established when 90% Confidence Interval falls within 80-125%.|Percent ratio|102.45||||0.4396|2-Sided|95.0|99.4|105.59|||ANOVA||||
1648038|NCT01750294|3031401|Superiority or Other|||||||0.01||||||a = 0.05|Mixed Models Analysis||||
1648039|NCT01750281|3031402|Non-Inferiority or Equivalence (legacy)|A hazard ratio <1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.18||||0.485|2-Sided|90.0|0.8|1.78|||Cox Proportional Hazards||||
1648040|NCT01750281|3031402|Non-Inferiority or Equivalence (legacy)|A hazard ratio <1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.43||||0.126|2-Sided|90.0|0.97|2.13|||Cox Proportional Hazards||||
1648041|NCT01750281|3031403|Non-Inferiority or Equivalence (legacy)|A hazard ratio <1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|0.92||||0.69|2-Sided|90.0|0.65|1.31|||Cox Proportional Hazards||||
1648042|NCT01750281|3031403|Non-Inferiority or Equivalence (legacy)|A hazard ratio <1 favours selumetinib in combination with docetaxel|Hazard Ratio (HR)|1.12||||0.584|2-Sided|90.0|0.8|1.61|||Cox Proportional Hazards||||
1648043|NCT01750242|3031414|Superiority or Other||Mean Difference (Net)|-22.5|Standard Deviation|8.7|||2-Sided|95.0|-26.5|-18.4||||||Summary statistics on the UPDRS III score. A higher score is more motor dysfunction.|
1648044|NCT01750242|3031415|Superiority or Other||% of leads|86.5|||||1-Sided|95.0|73.7|||||||A 95% lower confidence bound was calculated on the percentage of leads where an overlap existed. A subject may have 1 or 2 leads included in the analysis.|
1648045|NCT01750229|3031416|Superiority|||||||0.002|||||||Mixed Models Analysis|Variables included in the Mixed Model were: baseline VAS back pain score, treatment group, and period.|||
1648046|NCT01749930|3031434|Other||||||||||||||||||No statistical analysis was performed on these proportions
1648047|NCT01749930|3031435|Other|||||||0.007|||||||Chi-squared||||
1648048|NCT01749930|3031436|Other|||||||0.084|||||||Chi-squared||||
1648049|NCT01749930|3031437|Non-Inferiority|The 2 treatments were compared for each time point by visit. LS mean of each treatment group, the difference in the LS mean, and the 2-sided 95% CI for the difference were obtained. Noninferiority could be claimed if the upper limit of the CIs <1.5 mmHg at all time points of each visit and <1.00 mmHg for at least 5 out of the 9 time points. If noninferiority was determined, superiority at each time point could be claimed if the upper limit of the 95% CI<0 mmHg at all time points of each visit.||||||0.216||||||The ANCOVA results for the comparison of LS means of mean IOP between treatment groups demonstrated noninferiority of BOL-303259-X to timolol. Superiority of BOL-303259-X to timolol was demonstrated at 8 of 9 time points (exception at 8 am Week 2).|ANCOVA||||
1648050|NCT01749904|3031438|Other||||||||||||||||||No statistical analysis was performed on these proportions.
1648051|NCT01749904|3031439|Other|||||||0.001|||||||Chi-squared||||
1648052|NCT01749904|3031440|Other|||||||0.005|||||||Chi-squared||||
1648053|NCT01749904|3031441|Non-Inferiority|The 2 treatments were compared for each time point by visit. LS mean of each treatment group, the difference in the LS mean, and the 2-sided 95% CI for the difference were obtained. Noninferiority could be claimed if the upper limit of the CIs <1.5 mmHg at all time points of each visit and <1.00 mmHg for at least 5 out of the 9 time points. If noninferiority was determined, superiority at each time point could be claimed if the upper limit of the 95% CI<0 mmHg at all time points of each visit.|||||<|0.01||||||The ANCOVA results for the comparison of LS means of mean IOP between treatment groups demonstrated noninferiority of BOL-303259-X to timolol and also superiority of BOL-303259-X to timolol|ANCOVA||||
1648054|NCT01749033|3031463|Superiority or Other (legacy)||Mean Difference (Final Values)|0.02||||0.05|2-Sided||||||Chi-squared||The reported p value was calculated.|We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.|
1648055|NCT01749033|3031465|Superiority or Other (legacy)|||||||0.76|||||||Chi-squared|||We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.|
1648056|NCT01748942|3031471|Superiority|||||||0.15|||||||Log Rank||||
1648057|NCT01748942|3031472|Superiority|||||||0.96|||||||Wilcoxon (Mann-Whitney)||||
1648058|NCT01748942|3031473|Superiority|||||||0.33|||||||Wilcoxon (Mann-Whitney)||||
1648059|NCT01748942|3031474|Superiority|||||||0.009|||||||Wilcoxon (Mann-Whitney)||||
1648060|NCT01748942|3031475|Superiority||||||<|0.001|||||||Log Rank||||
1648061|NCT01748942|3031478|Superiority|||||||0.25|||||||Mixed Models Analysis||||
1648782|NCT01737398|3032679|Other||Least Square Mean Difference|-19.73||||4e-08|2-Sided|95.0|-26.43|-13.03|||MMRM||||
1648062|NCT01748799|3031481|Superiority or Other|||||||0.01||||||The level for statistical significance was p< 0.05.|ANOVA|||Omnibus analysis for Cannabis Withdrawal Checklist (CWC) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p< 0.05.|
1648063|NCT01748799|3031481|Superiority or Other||||||<|0.01||||||The level for statistical significance was p< 0.05.|ANOVA|||Omnibus analysis for Cannabis Withdrawal Scale (CWS) data was a Repeated measures ANOVA (including all the experimental conditions) followed by pair-wise comparisons. The level for statistical significance was p< 0.05.|
1648064|NCT01748760|3031484|Superiority or Other|||||||0.87|||||||Chi-squared||||
1648065|NCT01748695|3031486|Superiority or Other|||||||0.834||||||Based on a linear mixed measures model with treatment and period included as fixed effects, subject included as a random effect and between- and within- subject baseline covariates included.|Regression, Linear||||
1648066|NCT01748643|3031487|Superiority|||||||0.58|||||||t-test, 1 sided||||
1648067|NCT01748643|3031488|Superiority|||||||0.64|||||||t-test, 1 sided||||
1648068|NCT01748643|3031489|Superiority|||||||0.97|||||||t-test, 1 sided||||
1648069|NCT01748643|3031490|Superiority|||||||0.07|||||||Wilcoxon (Mann-Whitney)||||
1648070|NCT01748643|3031491|Superiority|||||||0.69|||||||Wilcoxon (Mann-Whitney)||||
1648071|NCT01748643|3031492|Superiority|||||||0.16|||||||Wilcoxon (Mann-Whitney)||||
1648072|NCT01747915|3031550|Superiority||Odds Ratio (OR)|0.934||||0.8474|2-Sided|95.0|0.465|1.877||P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.|Regression, Logistic||||
1648073|NCT01747915|3031550|Superiority||Odds Ratio (OR)|1.095||||0.7973|2-Sided|95.0|0.548|2.186||P-values were from a Logistic Regression Model including fixed effects for region, age strata and treatment.|Regression, Logistic||||
1648074|NCT01747915|3031551|Superiority||LS Mean Difference|-0.01|Standard Error of the Mean|0.088||0.8889|2-Sided|95.0|-0.19|0.16|||ANCOVA|||Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.|
1648075|NCT01747915|3031551|Superiority||Least Square (LS) Mean Difference|0.02|Standard Error of the Mean|0.088||0.8121|2-Sided|95.0|-0.15|0.19|||ANCOVA|||Estimates and p-values from an ANCOVA model including fixed effects for log transformed baseline value, region, age strata, and treatment group.|
1648076|NCT01747629|3031609|Superiority or Other||Mean Difference (Final Values)|0.93|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|0.57|1.28||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially [day 1, then day 8, then day 85] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.|||
1648077|NCT01747629|3031610|Superiority or Other||Mean Difference (Final Values)|0.77|Standard Error of the Mean|0.212||0.0004|2-Sided|95.0|0.35|1.19||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially [day 1, then day 8, then day 85] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.|||
1648078|NCT01747629|3031611|Superiority or Other||Mean Difference (Final Values)|1.05|Standard Error of the Mean|0.249|<|0.0001|2-Sided|95.0|0.56|1.55||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially [day 1, then day 8, then day 85] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.|||
1648079|NCT01747629|3031612|Superiority or Other||Mean Difference (Final Values)|0.92|Standard Error of the Mean|0.163|<|0.0001|2-Sided|95.0|0.59|1.24||Significance at the 0.05 level.|mixed-model repeated-measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.|||
1648080|NCT01747551|3031616|Superiority|||||||0.72|||||||Log Rank||||
1648081|NCT01746940|3031639|Superiority or Other|||||||0.0005||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.|
1648082|NCT01746940|3031639|Superiority or Other|||||||0.1088||||||One-sided p-value|Fisher Exact|||The null hypothesis is that the proportions of treatment group successes are equal.|
1648083|NCT01746901|3031652|Superiority or Other||LS Mean Difference|-0.5||||0.5092|2-Sided|95.0|-2.1|1.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648084|NCT01746901|3031652|Superiority or Other||LS Mean Difference|-0.1||||0.8857|2-Sided|95.0|-1.7|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648085|NCT01746901|3031652|Superiority or Other||LS Mean Difference|-0.4||||0.6192|2-Sided|95.0|-1.9|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648086|NCT01746901|3031652|Superiority or Other||LS Mean Difference|-0.2||||0.8478|2-Sided|95.0|-1.7|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648087|NCT01746901|3031652|Superiority or Other||LS Mean Difference|2.9||||0.0004|2-Sided|95.0|1.3|4.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648088|NCT01746901|3031652|Superiority or Other||LS Mean Difference|-3.4|||<|0.0001|2-Sided|95.0|-5.0|-1.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648089|NCT01746901|3031653|Superiority or Other||LS Mean Difference|100.0||||0.0273|2-Sided|95.0|11.3|188.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648090|NCT01746901|3031653|Superiority or Other||LS Mean Difference|147.8||||0.0013|2-Sided|95.0|59.0|236.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648091|NCT01746901|3031653|Superiority or Other||LS Mean Difference|138.9||||0.0023|2-Sided|95.0|50.3|227.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648092|NCT01746901|3031653|Superiority or Other||LS Mean Difference|190.9|||<|0.0001|2-Sided|95.0|102.1|279.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648093|NCT01746901|3031653|Superiority or Other||LS Mean Difference|133.9|||<|0.0034|2-Sided|95.0|45.0|222.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648094|NCT01746901|3031653|Superiority or Other||LS Mean Difference|196.0|||<|0.0001|2-Sided|95.0|107.4|284.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648095|NCT01746901|3031653|Superiority or Other||LS Mean Difference|109.6|||<|0.011|2-Sided|95.0|25.5|193.6|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648096|NCT01746901|3031653|Superiority or Other||LS Mean Difference|148.1|||<|0.0007|2-Sided|95.0|63.9|232.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648097|NCT01746901|3031653|Superiority or Other||LS Mean Difference|147.0|||<|0.0007|2-Sided|95.0|63.0|231.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648098|NCT01746901|3031653|Superiority or Other||LS Mean Difference|192.9|||<|0.0001|2-Sided|95.0|108.7|277.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648099|NCT01746901|3031653|Superiority or Other||LS Mean Difference|137.6|||<|0.0015|2-Sided|95.0|53.3|221.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648100|NCT01746901|3031653|Superiority or Other||LS Mean Difference|202.4|||<|0.0001|2-Sided|95.0|118.4|286.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648101|NCT01746901|3031653|Superiority or Other||LS Mean Difference|126.7|||<|0.0002|2-Sided|95.0|61.7|191.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648102|NCT01746901|3031653|Superiority or Other||LS Mean Difference|143.2|||<|0.0001|2-Sided|95.0|78.0|208.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648103|NCT01746901|3031653|Superiority or Other||LS Mean Difference|154.3|||<|0.0001|2-Sided|95.0|89.2|219.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648104|NCT01746901|3031653|Superiority or Other||LS Mean Difference|195.4|||<|0.0001|2-Sided|95.0|130.2|260.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648105|NCT01746901|3031653|Superiority or Other||LS Mean Difference|71.3|||<|0.0322|2-Sided|95.0|6.1|136.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648106|NCT01746901|3031653|Superiority or Other||LS Mean Difference|278.3|||<|0.0001|2-Sided|95.0|213.2|343.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648107|NCT01746901|3031653|Superiority or Other||LS Mean Difference|113.6|||<|0.0001|2-Sided|95.0|62.1|165.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648108|NCT01746901|3031653|Superiority or Other||LS Mean Difference|135.6|||<|0.0001|2-Sided|95.0|84.0|187.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648109|NCT01746901|3031653|Superiority or Other||LS Mean Difference|148.3|||<|0.0001|2-Sided|95.0|96.8|199.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648110|NCT01746901|3031653|Superiority or Other||LS Mean Difference|167.3|||<|0.0001|2-Sided|95.0|115.7|218.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648111|NCT01746901|3031653|Superiority or Other||LS Mean Difference|31.2|||<|0.2336|2-Sided|95.0|-20.4|82.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648112|NCT01746901|3031653|Superiority or Other||LS Mean Difference|284.3|||<|0.0001|2-Sided|95.0|232.9|335.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648113|NCT01746901|3031653|Superiority or Other||LS Mean Difference|19.3|||<|0.0001|2-Sided|95.0|11.8|26.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648608|NCT01746264|3031741|Superiority or Other|||||||0.0123|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.|
1648114|NCT01746901|3031653|Superiority or Other||LS Mean Difference|20.7|||<|0.0001|2-Sided|95.0|13.1|28.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648115|NCT01746901|3031653|Superiority or Other||LS Mean Difference|26.6|||<|0.0001|2-Sided|95.0|19.1|34.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648116|NCT01746901|3031653|Superiority or Other||LS Mean Difference|18.3|||<|0.0001|2-Sided|95.0|10.7|25.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648117|NCT01746901|3031653|Superiority or Other||LS Mean Difference|3.4|||<|0.3763|2-Sided|95.0|-4.2|10.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648118|NCT01746901|3031653|Superiority or Other||LS Mean Difference|41.5|||<|0.0001|2-Sided|95.0|33.9|49.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648119|NCT01746901|3031654|Superiority or Other||LS Mean Difference|1.7||||0.031|2-Sided|95.0|0.2|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648120|NCT01746901|3031654|Superiority or Other||LS Mean Difference|-1.0||||0.193|2-Sided|95.0|-2.6|0.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648121|NCT01746901|3031654|Superiority or Other||LS Mean Difference|1.3||||0.0962|2-Sided|95.0|-0.2|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648122|NCT01746901|3031654|Superiority or Other||LS Mean Difference|-0.4||||0.645|2-Sided|95.0|-2.0|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648123|NCT01746901|3031654|Superiority or Other||LS Mean Difference|2.7||||0.0008|2-Sided|95.0|1.1|4.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648124|NCT01746901|3031654|Superiority or Other||LS Mean Difference|-1.8||||0.0298|2-Sided|95.0|-3.3|-0.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648125|NCT01746901|3031655|Superiority or Other||LS Mean Difference|88.6||||0.0952|2-Sided|95.0|-15.7|192.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648126|NCT01746901|3031655|Superiority or Other||LS Mean Difference|60.2||||0.2558|2-Sided|95.0|-44.1|164.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648127|NCT01746901|3031655|Superiority or Other||LS Mean Difference|103.2||||0.0525|2-Sided|95.0|-1.1|207.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648128|NCT01746901|3031655|Superiority or Other||LS Mean Difference|118.7||||0.0259|2-Sided|95.0|14.5|223.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648129|NCT01746901|3031655|Superiority or Other||LS Mean Difference|-21.0||||0.6906|2-Sided|95.0|-125.3|83.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648130|NCT01746901|3031655|Superiority or Other||LS Mean Difference|242.9|||<|0.0001|2-Sided|95.0|138.6|347.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648131|NCT01746901|3031655|Superiority or Other||LS Mean Difference|64.4|||<|0.11|2-Sided|95.0|-14.7|143.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648132|NCT01746901|3031655|Superiority or Other||LS Mean Difference|68.7|||<|0.0883|2-Sided|95.0|-10.4|147.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648133|NCT01746901|3031655|Superiority or Other||LS Mean Difference|83.3|||<|0.0392|2-Sided|95.0|4.2|162.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648134|NCT01746901|3031655|Superiority or Other||LS Mean Difference|114.1|||<|0.005|2-Sided|95.0|35.0|193.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648135|NCT01746901|3031655|Superiority or Other||LS Mean Difference|1.4|||<|0.9726|2-Sided|95.0|-77.7|80.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648136|NCT01746901|3031655|Superiority or Other||LS Mean Difference|196.0|||<|0.0001|2-Sided|95.0|116.9|275.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648137|NCT01746901|3031655|Superiority or Other||LS Mean Difference|39.4|||<|0.1078|2-Sided|95.0|-8.7|87.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648609|NCT01746264|3031742|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.|
1649229|NCT01728454|3033790|Superiority|||||||0.2864|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle|
1648138|NCT01746901|3031655|Superiority or Other||LS Mean Difference|63.6|||<|0.0098|2-Sided|95.0|15.6|111.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648139|NCT01746901|3031655|Superiority or Other||LS Mean Difference|77.1|||<|0.0018|2-Sided|95.0|29.1|125.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648140|NCT01746901|3031655|Superiority or Other||LS Mean Difference|81.3|||<|0.0011|2-Sided|95.0|33.2|129.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648141|NCT01746901|3031655|Superiority or Other||LS Mean Difference|15.8|||<|0.5169|2-Sided|95.0|-32.3|63.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648142|NCT01746901|3031655|Superiority or Other||LS Mean Difference|142.6|||<|0.0001|2-Sided|95.0|94.5|190.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648143|NCT01746901|3031655|Superiority or Other||LS Mean Difference|31.9|||<|0.064|2-Sided|95.0|-1.9|65.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648144|NCT01746901|3031655|Superiority or Other||LS Mean Difference|60.3|||<|0.0006|2-Sided|95.0|26.5|94.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648145|NCT01746901|3031655|Superiority or Other||LS Mean Difference|66.3|||<|0.0002|2-Sided|95.0|32.5|100.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648146|NCT01746901|3031655|Superiority or Other||LS Mean Difference|65.8|||<|0.0002|2-Sided|95.0|32.0|99.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648147|NCT01746901|3031655|Superiority or Other||LS Mean Difference|4.7|||<|0.7837|2-Sided|95.0|-29.1|38.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648148|NCT01746901|3031655|Superiority or Other||LS Mean Difference|127.4|||<|0.0001|2-Sided|95.0|93.6|161.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648149|NCT01746901|3031655|Superiority or Other||LS Mean Difference|7.6|||<|0.001|2-Sided|95.0|3.2|12.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648150|NCT01746901|3031655|Superiority or Other||LS Mean Difference|7.1|||<|0.0019|2-Sided|95.0|2.7|11.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648151|NCT01746901|3031655|Superiority or Other||LS Mean Difference|11.0|||<|0.0001|2-Sided|95.0|6.5|15.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648152|NCT01746901|3031655|Superiority or Other||LS Mean Difference|8.6|||<|0.0002|2-Sided|95.0|4.2|13.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648153|NCT01746901|3031655|Superiority or Other||LS Mean Difference|0.6|||<|0.8048|2-Sided|95.0|-3.9|5.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648154|NCT01746901|3031655|Superiority or Other||LS Mean Difference|19.0|||<|0.0001|2-Sided|95.0|14.6|23.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648155|NCT01746901|3031656|Superiority or Other||LS Mean Difference|-4.45|||<|0.0001|2-Sided|95.0|-6.62|-2.28|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648156|NCT01746901|3031656|Superiority or Other||LS Mean Difference|-0.39|||<|0.7242|2-Sided|95.0|-2.55|1.78|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648157|NCT01746901|3031656|Superiority or Other||LS Mean Difference|-4.61|||<|0.0001|2-Sided|95.0|-6.78|-2.44|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648158|NCT01746901|3031656|Superiority or Other||LS Mean Difference|0.03|||<|0.9766|2-Sided|95.0|-2.13|2.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648159|NCT01746901|3031656|Superiority or Other||LS Mean Difference|5.16|||<|0.0001|2-Sided|95.0|2.99|7.32|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648160|NCT01746901|3031656|Superiority or Other||LS Mean Difference|-9.73|||<|0.0001|2-Sided|95.0|-11.9|-7.57|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648161|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-23.7|||<|0.0001|2-Sided|95.0|-28.62|-18.78|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648610|NCT01746264|3031743|Superiority or Other|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3-month follow-up.|
1649230|NCT01728454|3033790|Superiority|||||||0.0303|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle|
1648162|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-13.53|||<|0.0001|2-Sided|95.0|-18.41|-8.64|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648163|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-24.91|||<|0.0001|2-Sided|95.0|-29.83|-20.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648164|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-22.18|||<|0.0001|2-Sided|95.0|-27.09|-17.27|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648165|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-57.74|||<|0.0001|2-Sided|95.0|-62.63|-52.85|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648166|NCT01746901|3031657|Superiority or Other||LS Mean Difference|10.64|||<|0.0001|2-Sided|95.0|5.75|15.54|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648167|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-20.59|||<|0.0001|2-Sided|95.0|-23.98|-17.21|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648168|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-12.5|||<|0.0001|2-Sided|95.0|-15.86|-9.14|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648169|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-22.28|||<|0.0001|2-Sided|95.0|-25.67|-18.9|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648170|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-19.63|||<|0.0001|2-Sided|95.0|-23.01|-16.25|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648171|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-41.66|||<|0.0001|2-Sided|95.0|-45.02|-38.29|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648172|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-0.26|||<|0.8784|2-Sided|95.0|-3.63|3.11|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648173|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-14.19|||<|0.0001|2-Sided|95.0|-15.99|-12.39|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648174|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-8.88|||<|0.0001|2-Sided|95.0|-10.67|-7.09|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648175|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-15.71|||<|0.0001|2-Sided|95.0|-17.51|-13.91|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648176|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-11.73|||<|0.0001|2-Sided|95.0|-13.53|-9.93|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648177|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-16.07|||<|0.0001|2-Sided|95.0|-17.86|-14.28|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648178|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-11.37|||<|0.0001|2-Sided|95.0|-13.16|-9.58|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648179|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-10.36|||<|0.0001|2-Sided|95.0|-11.67|-9.05|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648180|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-6.35|||<|0.0001|2-Sided|95.0|-7.65|-5.05|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648181|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-11.24|||<|0.0001|2-Sided|95.0|-12.55|-9.94|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648182|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-7.9|||<|0.0001|2-Sided|95.0|-9.2|-6.59|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648183|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-7.23|||<|0.0001|2-Sided|95.0|-8.54|-5.93|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648184|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-11.91|||<|0.0001|2-Sided|95.0|-13.21|-10.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648185|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-2.42|||<|0.0001|2-Sided|95.0|-2.76|-2.08|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648611|NCT01746264|3031744|Superiority or Other|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.|
1648186|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-1.34|||<|0.0001|2-Sided|95.0|-1.68|-1.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648187|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-2.62|||<|0.0001|2-Sided|95.0|-2.96|-2.27|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648188|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-1.61|||<|0.0001|2-Sided|95.0|-1.96|-1.27|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648189|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-0.2|||<|0.2475|2-Sided|95.0|-0.54|0.14|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648190|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-4.03|||<|0.0001|2-Sided|95.0|-4.37|-3.69|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648191|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-1.04|||<|0.0001|2-Sided|95.0|-1.21|-0.88|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648192|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-0.42|||<|0.0001|2-Sided|95.0|-0.59|-0.26|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648193|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-1.09|||<|0.0001|2-Sided|95.0|-1.25|-0.92|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648194|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-0.58|||<|0.0001|2-Sided|95.0|-0.74|-0.42|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648195|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-0.08|||<|0.3309|2-Sided|95.0|-0.24|0.08|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648196|NCT01746901|3031657|Superiority or Other||LS Mean Difference|-1.59|||<|0.0001|2-Sided|95.0|-1.75|-1.42|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648197|NCT01746901|3031658|Superiority or Other||LS Mean Difference|-1.29|||<|0.0001|2-Sided|95.0|-1.46|-1.11|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648198|NCT01746901|3031658|Superiority or Other||LS Mean Difference|-0.74|||<|0.0001|2-Sided|95.0|-0.91|-0.56|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648199|NCT01746901|3031658|Superiority or Other||LS Mean Difference|-1.4|||<|0.0001|2-Sided|95.0|-1.58|-1.23|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648200|NCT01746901|3031658|Superiority or Other||LS Mean Difference|-0.8|||<|0.0001|2-Sided|95.0|-0.97|-0.63|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648201|NCT01746901|3031658|Superiority or Other||LS Mean Difference|-1.69|||<|0.0001|2-Sided|95.0|-1.86|-1.52|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648202|NCT01746901|3031658|Superiority or Other||LS Mean Difference|-0.51|||<|0.0001|2-Sided|95.0|-0.69|-0.34|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648203|NCT01746901|3031659|Superiority or Other||LS Mean Difference|1.9||||0.05|2-Sided|95.0|0.0|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648204|NCT01746901|3031659|Superiority or Other||LS Mean Difference|-0.7||||0.4456|2-Sided|95.0|-2.7|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648205|NCT01746901|3031659|Superiority or Other||LS Mean Difference|0.9||||0.3647|2-Sided|95.0|-1.0|2.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648206|NCT01746901|3031659|Superiority or Other||LS Mean Difference|0.4||||0.7216|2-Sided|95.0|-1.6|2.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648207|NCT01746901|3031659|Superiority or Other||LS Mean Difference|1.8||||0.0626|2-Sided|95.0|-0.1|3.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648208|NCT01746901|3031659|Superiority or Other||LS Mean Difference|-0.6||||0.5494|2-Sided|95.0|-2.5|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648209|NCT01746901|3031660|Superiority or Other||LS Mean Difference|29.5||||0.4801|2-Sided|95.0|-52.9|112.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648210|NCT01746901|3031660|Superiority or Other||LS Mean Difference|36.1||||0.3885|2-Sided|95.0|-46.3|118.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648211|NCT01746901|3031660|Superiority or Other||LS Mean Difference|21.8||||0.6014|2-Sided|95.0|-60.6|104.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648212|NCT01746901|3031660|Superiority or Other||LS Mean Difference|81.7||||0.054|2-Sided|95.0|-1.4|164.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648213|NCT01746901|3031660|Superiority or Other||LS Mean Difference|115.0||||0.0066|2-Sided|95.0|32.6|197.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648214|NCT01746901|3031660|Superiority or Other||LS Mean Difference|-11.4||||0.7875|2-Sided|95.0|-94.7|71.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648215|NCT01746901|3031660|Superiority or Other||LS Mean Difference|39.1||||0.2662|2-Sided|95.0|-30.1|108.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648216|NCT01746901|3031660|Superiority or Other||LS Mean Difference|35.9||||0.3077|2-Sided|95.0|-33.4|105.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648217|NCT01746901|3031660|Superiority or Other||LS Mean Difference|32.0||||0.3629|2-Sided|95.0|-37.3|101.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648218|NCT01746901|3031660|Superiority or Other||LS Mean Difference|81.5||||0.0226|2-Sided|95.0|11.6|151.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648219|NCT01746901|3031660|Superiority or Other||LS Mean Difference|110.4||||0.002|2-Sided|95.0|41.2|179.6|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648220|NCT01746901|3031660|Superiority or Other||LS Mean Difference|3.0||||0.9318|2-Sided|95.0|-66.9|73.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648221|NCT01746901|3031660|Superiority or Other||LS Mean Difference|46.1||||0.0427|2-Sided|95.0|1.5|90.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648222|NCT01746901|3031660|Superiority or Other||LS Mean Difference|35.5||||0.1174|2-Sided|95.0|-9.0|80.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648223|NCT01746901|3031660|Superiority or Other||LS Mean Difference|39.6||||0.0812|2-Sided|95.0|-5.0|84.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648224|NCT01746901|3031660|Superiority or Other||LS Mean Difference|82.8||||0.0004|2-Sided|95.0|37.8|127.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648225|NCT01746901|3031660|Superiority or Other||LS Mean Difference|45.4||||0.0456|2-Sided|95.0|0.9|89.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648226|NCT01746901|3031660|Superiority or Other||LS Mean Difference|76.9||||0.0009|2-Sided|95.0|31.9|121.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648227|NCT01746901|3031660|Superiority or Other||LS Mean Difference|45.5||||0.0187|2-Sided|95.0|7.7|83.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648228|NCT01746901|3031660|Superiority or Other||LS Mean Difference|28.9||||0.1329|2-Sided|95.0|-8.9|66.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648229|NCT01746901|3031660|Superiority or Other||LS Mean Difference|39.3||||0.0414|2-Sided|95.0|1.6|77.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648230|NCT01746901|3031660|Superiority or Other||LS Mean Difference|78.6|||<|0.0001|2-Sided|95.0|40.5|116.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648231|NCT01746901|3031660|Superiority or Other||LS Mean Difference|21.9|||<|0.253|2-Sided|95.0|-15.8|59.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648232|NCT01746901|3031660|Superiority or Other||LS Mean Difference|96.1|||<|0.0001|2-Sided|95.0|57.9|134.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648233|NCT01746901|3031660|Superiority or Other||LS Mean Difference|22.6|||<|0.0006|2-Sided|95.0|9.8|35.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648234|NCT01746901|3031660|Superiority or Other||LS Mean Difference|5.2|||<|0.4224|2-Sided|95.0|-7.6|18.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648612|NCT01746264|3031746|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.|
1648235|NCT01746901|3031660|Superiority or Other||LS Mean Difference|17.2|||<|0.0089|2-Sided|95.0|4.4|30.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648236|NCT01746901|3031660|Superiority or Other||LS Mean Difference|17.4|||<|0.0086|2-Sided|95.0|4.5|30.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648237|NCT01746901|3031660|Superiority or Other||LS Mean Difference|1.6|||<|0.8009|2-Sided|95.0|-11.2|14.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648238|NCT01746901|3031660|Superiority or Other||LS Mean Difference|33.0|||<|0.0001|2-Sided|95.0|20.0|45.9|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648239|NCT01746901|3031660|Superiority or Other||LS Mean Difference|6.8|||<|0.0096|2-Sided|95.0|1.7|11.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648240|NCT01746901|3031660|Superiority or Other||LS Mean Difference|3.2|||<|0.2168|2-Sided|95.0|-1.9|8.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648241|NCT01746901|3031660|Superiority or Other||LS Mean Difference|5.9|||<|0.0229|2-Sided|95.0|0.8|11.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648242|NCT01746901|3031660|Superiority or Other||LS Mean Difference|7.3|||<|0.0058|2-Sided|95.0|2.2|12.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648243|NCT01746901|3031660|Superiority or Other||LS Mean Difference|1.0|||<|0.6868|2-Sided|95.0|-4.1|6.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648244|NCT01746901|3031660|Superiority or Other||LS Mean Difference|12.2|||<|0.0001|2-Sided|95.0|7.1|17.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648245|NCT01746901|3031661|Superiority or Other||LS Mean Difference|19.5||||0.0008|2-Sided|95.0|8.3|30.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648246|NCT01746901|3031661|Superiority or Other||LS Mean Difference|7.4||||0.1974|2-Sided|95.0|-3.9|18.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648247|NCT01746901|3031661|Superiority or Other||LS Mean Difference|15.8||||0.0064|2-Sided|95.0|4.5|27.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648248|NCT01746901|3031661|Superiority or Other||LS Mean Difference|20.9||||0.0004|2-Sided|95.0|9.5|32.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648249|NCT01746901|3031661|Superiority or Other||LS Mean Difference|8.4||||0.1421|2-Sided|95.0|-2.8|19.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648250|NCT01746901|3031661|Superiority or Other||LS Mean Difference|28.2|||<|0.0001|2-Sided|95.0|16.8|39.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648251|NCT01746901|3031662|Superiority or Other||LS Mean Difference|1.0||||0.2322|2-Sided|95.0|-0.6|2.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648252|NCT01746901|3031662|Superiority or Other||LS Mean Difference|0.0||||0.9944|2-Sided|95.0|-1.6|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648253|NCT01746901|3031662|Superiority or Other||LS Mean Difference|1.1||||0.1868|2-Sided|95.0|-0.5|2.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648254|NCT01746901|3031662|Superiority or Other||LS Mean Difference|-0.3||||0.7508|2-Sided|95.0|-1.9|1.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648255|NCT01746901|3031662|Superiority or Other||LS Mean Difference|2.6||||0.0019|2-Sided|95.0|1.0|4.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648256|NCT01746901|3031662|Superiority or Other||LS Mean Difference|-1.8||||0.0327|2-Sided|95.0|-3.4|-0.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648257|NCT01746901|3031663|Superiority or Other||LS Mean Difference|153.6||||0.0284|2-Sided|95.0|16.4|290.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648258|NCT01746901|3031663|Superiority or Other||LS Mean Difference|108.7||||0.1189|2-Sided|95.0|-28.3|245.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648259|NCT01746901|3031663|Superiority or Other||LS Mean Difference|210.4||||0.0029|2-Sided|95.0|73.0|347.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648260|NCT01746901|3031663|Superiority or Other||LS Mean Difference|106.0||||0.1298|2-Sided|95.0|-31.5|243.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648261|NCT01746901|3031663|Superiority or Other||LS Mean Difference|220.3||||0.0019|2-Sided|95.0|82.6|358.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648262|NCT01746901|3031663|Superiority or Other||LS Mean Difference|96.1||||0.1688|2-Sided|95.0|-41.2|233.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648263|NCT01746901|3031663|Superiority or Other||LS Mean Difference|181.3||||0.0033|2-Sided|95.0|61.5|301.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648264|NCT01746901|3031663|Superiority or Other||LS Mean Difference|107.2||||0.0787|2-Sided|95.0|-12.4|226.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648265|NCT01746901|3031663|Superiority or Other||LS Mean Difference|223.2||||0.0003|2-Sided|95.0|103.2|343.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648266|NCT01746901|3031663|Superiority or Other||LS Mean Difference|126.7||||0.0388|2-Sided|95.0|6.6|246.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648267|NCT01746901|3031663|Superiority or Other||LS Mean Difference|221.5||||0.0004|2-Sided|95.0|101.2|341.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648268|NCT01746901|3031663|Superiority or Other||LS Mean Difference|128.4||||0.036|2-Sided|95.0|8.5|248.3|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648269|NCT01746901|3031663|Superiority or Other||LS Mean Difference|168.1|||<|0.0001|2-Sided|95.0|89.7|246.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648270|NCT01746901|3031663|Superiority or Other||LS Mean Difference|111.1|||<|0.0057|2-Sided|95.0|32.8|189.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648271|NCT01746901|3031663|Superiority or Other||LS Mean Difference|198.0|||<|0.0001|2-Sided|95.0|119.4|276.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648272|NCT01746901|3031663|Superiority or Other||LS Mean Difference|164.4|||<|0.0001|2-Sided|95.0|85.8|243.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648273|NCT01746901|3031663|Superiority or Other||LS Mean Difference|121.1|||<|0.0028|2-Sided|95.0|42.4|199.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648274|NCT01746901|3031663|Superiority or Other||LS Mean Difference|241.3|||<|0.0001|2-Sided|95.0|162.8|319.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648275|NCT01746901|3031663|Superiority or Other||LS Mean Difference|138.4|||<|0.0001|2-Sided|95.0|78.7|198.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648276|NCT01746901|3031663|Superiority or Other||LS Mean Difference|97.9|||<|0.0015|2-Sided|95.0|38.3|157.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648277|NCT01746901|3031663|Superiority or Other||LS Mean Difference|165.4|||<|0.0001|2-Sided|95.0|105.6|225.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648278|NCT01746901|3031663|Superiority or Other||LS Mean Difference|151.2|||<|0.0001|2-Sided|95.0|91.3|211.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648279|NCT01746901|3031663|Superiority or Other||LS Mean Difference|68.2|||<|0.0263|2-Sided|95.0|8.2|128.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648280|NCT01746901|3031663|Superiority or Other||LS Mean Difference|248.4|||<|0.0001|2-Sided|95.0|188.6|308.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648281|NCT01746901|3031663|Superiority or Other||LS Mean Difference|25.0|||<|0.0035|2-Sided|95.0|8.4|41.6|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648282|NCT01746901|3031663|Superiority or Other||LS Mean Difference|22.9|||<|0.0072|2-Sided|95.0|6.3|39.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648283|NCT01746901|3031663|Superiority or Other||LS Mean Difference|29.6|||<|0.0006|2-Sided|95.0|12.9|46.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648613|NCT01746264|3031747|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow up visit.|
1648284|NCT01746901|3031663|Superiority or Other||LS Mean Difference|28.6|||<|0.0009|2-Sided|95.0|11.9|45.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648285|NCT01746901|3031663|Superiority or Other||LS Mean Difference|7.3|||<|0.3905|2-Sided|95.0|-9.4|24.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648286|NCT01746901|3031663|Superiority or Other||LS Mean Difference|50.9|||<|0.0001|2-Sided|95.0|34.2|67.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648287|NCT01746901|3031663|Superiority or Other||LS Mean Difference|4.6|||<|0.1354|2-Sided|95.0|-1.5|10.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648288|NCT01746901|3031663|Superiority or Other||LS Mean Difference|8.3|||<|0.0075|2-Sided|95.0|2.3|14.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648289|NCT01746901|3031663|Superiority or Other||LS Mean Difference|5.7|||<|0.0667|2-Sided|95.0|-0.4|11.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648290|NCT01746901|3031663|Superiority or Other||LS Mean Difference|10.4|||<|0.001|2-Sided|95.0|4.3|16.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648291|NCT01746901|3031663|Superiority or Other||LS Mean Difference|3.5|||<|0.255|2-Sided|95.0|-2.6|9.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648292|NCT01746901|3031663|Superiority or Other||LS Mean Difference|12.5|||<|0.0001|2-Sided|95.0|6.4|18.6|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648293|NCT01746901|3031664|Superiority or Other||LS Mean Difference|32.9|||<|0.0001|2-Sided|95.0|20.5|45.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648294|NCT01746901|3031664|Superiority or Other||LS Mean Difference|15.4|||<|0.0157|2-Sided|95.0|2.9|27.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648295|NCT01746901|3031664|Superiority or Other||LS Mean Difference|36.1|||<|0.0001|2-Sided|95.0|23.6|48.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648296|NCT01746901|3031664|Superiority or Other||LS Mean Difference|18.5|||<|0.0039|2-Sided|95.0|6.1|31.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648297|NCT01746901|3031664|Superiority or Other||LS Mean Difference|15.8|||<|0.0136|2-Sided|95.0|3.3|28.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648298|NCT01746901|3031664|Superiority or Other||LS Mean Difference|38.8|||<|0.0001|2-Sided|95.0|26.4|51.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648299|NCT01746901|3031665|Superiority or Other||LS Mean Difference|1.5||||0.2316|2-Sided|95.0|-1.0|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648300|NCT01746901|3031665|Superiority or Other||LS Mean Difference|-0.9||||0.4607|2-Sided|95.0|-3.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648301|NCT01746901|3031665|Superiority or Other||LS Mean Difference|0.9||||0.4746|2-Sided|95.0|-1.6|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648302|NCT01746901|3031665|Superiority or Other||LS Mean Difference|-0.2||||0.8765|2-Sided|95.0|-2.7|2.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648303|NCT01746901|3031665|Superiority or Other||LS Mean Difference|4.3||||0.0006|2-Sided|95.0|1.9|6.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648304|NCT01746901|3031665|Superiority or Other||LS Mean Difference|-3.6||||0.0041|2-Sided|95.0|-6.1|-1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648305|NCT01746901|3031666|Superiority or Other||LS Mean Difference|-5.3||||0.8833|2-Sided|95.0|-77.0|66.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648306|NCT01746901|3031666|Superiority or Other||LS Mean Difference|34.6||||0.3418|2-Sided|95.0|-37.1|106.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648307|NCT01746901|3031666|Superiority or Other||LS Mean Difference|-4.0||||0.9126|2-Sided|95.0|-75.7|67.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648308|NCT01746901|3031666|Superiority or Other||LS Mean Difference|23.1||||0.5294|2-Sided|95.0|-49.3|95.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648309|NCT01746901|3031666|Superiority or Other||LS Mean Difference|70.9||||0.0525|2-Sided|95.0|-0.8|142.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648310|NCT01746901|3031666|Superiority or Other||LS Mean Difference|-51.8||||0.1597|2-Sided|95.0|-124.2|20.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648311|NCT01746901|3031666|Superiority or Other||LS Mean Difference|3.9||||0.8905|2-Sided|95.0|-51.5|59.2|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648312|NCT01746901|3031666|Superiority or Other||LS Mean Difference|34.8||||0.2161|2-Sided|95.0|-20.6|90.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648313|NCT01746901|3031666|Superiority or Other||LS Mean Difference|6.0||||0.831|2-Sided|95.0|-49.4|61.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648314|NCT01746901|3031666|Superiority or Other||LS Mean Difference|22.9||||0.4189|2-Sided|95.0|-33.0|78.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648315|NCT01746901|3031666|Superiority or Other||LS Mean Difference|62.1||||0.0281|2-Sided|95.0|6.8|117.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648316|NCT01746901|3031666|Superiority or Other||LS Mean Difference|-33.2||||0.2425|2-Sided|95.0|-89.1|22.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648317|NCT01746901|3031666|Superiority or Other||LS Mean Difference|12.3||||0.3396|2-Sided|95.0|-13.1|37.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648318|NCT01746901|3031666|Superiority or Other||LS Mean Difference|22.9||||0.0763|2-Sided|95.0|-2.4|48.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648319|NCT01746901|3031666|Superiority or Other||LS Mean Difference|13.4||||0.2987|2-Sided|95.0|-12.0|38.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648320|NCT01746901|3031666|Superiority or Other||LS Mean Difference|23.3||||0.0738|2-Sided|95.0|-2.3|48.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648321|NCT01746901|3031666|Superiority or Other||LS Mean Difference|10.7||||0.4056|2-Sided|95.0|-14.6|36.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648322|NCT01746901|3031666|Superiority or Other||LS Mean Difference|26.0||||0.0467|2-Sided|95.0|0.4|51.6|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648323|NCT01746901|3031666|Superiority or Other||LS Mean Difference|12.2||||0.2904|2-Sided|95.0|-10.5|34.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648324|NCT01746901|3031666|Superiority or Other||LS Mean Difference|16.4||||0.1557|2-Sided|95.0|-6.3|39.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648325|NCT01746901|3031666|Superiority or Other||LS Mean Difference|10.1||||0.3797|2-Sided|95.0|-12.6|32.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648326|NCT01746901|3031666|Superiority or Other||LS Mean Difference|24.5||||0.0367|2-Sided|95.0|1.5|47.4|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648327|NCT01746901|3031666|Superiority or Other||LS Mean Difference|6.9||||0.5471|2-Sided|95.0|-15.8|29.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648328|NCT01746901|3031666|Superiority or Other||LS Mean Difference|27.7||||0.0185|2-Sided|95.0|4.7|50.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648329|NCT01746901|3031666|Superiority or Other||LS Mean Difference|3.7||||0.3479|2-Sided|95.0|-4.1|11.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648330|NCT01746901|3031666|Superiority or Other||LS Mean Difference|4.7||||0.2385|2-Sided|95.0|-3.1|12.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648331|NCT01746901|3031666|Superiority or Other||LS Mean Difference|0.7||||0.856|2-Sided|95.0|-7.1|8.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648332|NCT01746901|3031666|Superiority or Other||LS Mean Difference|5.3||||0.1809|2-Sided|95.0|-2.5|13.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648614|NCT01746264|3031748|Superiority or Other|||||||0.59|||||||Wilcoxon (Mann-Whitney)|||P-value for change from baseline to 3 month follow-up.|
1648333|NCT01746901|3031666|Superiority or Other||LS Mean Difference|-2.7||||0.4861|2-Sided|95.0|-10.5|5.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648334|NCT01746901|3031666|Superiority or Other||LS Mean Difference|8.8||||0.0283|2-Sided|95.0|0.9|16.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648335|NCT01746901|3031666|Superiority or Other||LS Mean Difference|-0.2||||0.9303|2-Sided|95.0|-3.6|3.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648336|NCT01746901|3031666|Superiority or Other||LS Mean Difference|2.6||||0.1452|2-Sided|95.0|-0.9|6.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648337|NCT01746901|3031666|Superiority or Other||LS Mean Difference|-1.2||||0.5035|2-Sided|95.0|-4.6|2.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648338|NCT01746901|3031666|Superiority or Other||LS Mean Difference|2.0||||0.2513|2-Sided|95.0|-1.5|5.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648339|NCT01746901|3031666|Superiority or Other||LS Mean Difference|-1.5||||0.3908|2-Sided|95.0|-5.0|1.9|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648340|NCT01746901|3031666|Superiority or Other||LS Mean Difference|2.4||||0.1828|2-Sided|95.0|-1.1|5.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648341|NCT01746901|3031667|Superiority or Other||LS Mean Difference|5.4||||0.3461|2-Sided|95.0|-5.8|16.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648342|NCT01746901|3031667|Superiority or Other||LS Mean Difference|6.2||||0.2725|2-Sided|95.0|-5.0|17.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648343|NCT01746901|3031667|Superiority or Other||LS Mean Difference|5.2||||0.3604|2-Sided|95.0|-6.0|16.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648344|NCT01746901|3031667|Superiority or Other||LS Mean Difference|11.5||||0.0469|2-Sided|95.0|0.2|22.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648345|NCT01746901|3031667|Superiority or Other||LS Mean Difference|3.4||||0.5513|2-Sided|95.0|-7.8|14.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648346|NCT01746901|3031667|Superiority or Other||LS Mean Difference|13.3||||0.0217|2-Sided|95.0|2.0|24.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648347|NCT01746901|3031668|Superiority or Other||LS Mean Difference|-0.7||||0.5592|2-Sided|95.0|-3.0|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648348|NCT01746901|3031668|Superiority or Other||LS Mean Difference|-0.8||||0.4999|2-Sided|95.0|-3.1|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648349|NCT01746901|3031668|Superiority or Other||LS Mean Difference|-0.7||||0.5473|2-Sided|95.0|-3.0|1.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648350|NCT01746901|3031668|Superiority or Other||LS Mean Difference|0.4||||0.7307|2-Sided|95.0|-1.9|2.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648351|NCT01746901|3031668|Superiority or Other||LS Mean Difference|1.3||||0.2616|2-Sided|95.0|-1.0|3.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648352|NCT01746901|3031668|Superiority or Other||LS Mean Difference|-1.6||||0.1728|2-Sided|95.0|-3.9|0.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648353|NCT01746901|3031669|Superiority or Other||LS Mean Difference|-12.6||||0.6699|2-Sided|95.0|-71.0|45.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648354|NCT01746901|3031669|Superiority or Other||LS Mean Difference|7.0||||0.8136|2-Sided|95.0|-51.4|65.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648355|NCT01746901|3031669|Superiority or Other||LS Mean Difference|-13.6||||0.647|2-Sided|95.0|-71.9|44.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648356|NCT01746901|3031669|Superiority or Other||LS Mean Difference|15.2||||0.6095|2-Sided|95.0|-43.6|74.1|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648357|NCT01746901|3031669|Superiority or Other||LS Mean Difference|64.0||||0.0318|2-Sided|95.0|5.7|122.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648358|NCT01746901|3031669|Superiority or Other||LS Mean Difference|-62.3||||0.0381|2-Sided|95.0|-121.2|-3.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648359|NCT01746901|3031669|Superiority or Other||LS Mean Difference|-4.0||||0.8507|2-Sided|95.0|-45.8|37.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648360|NCT01746901|3031669|Superiority or Other||LS Mean Difference|8.1||||0.7031|2-Sided|95.0|-33.8|49.9|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648361|NCT01746901|3031669|Superiority or Other||LS Mean Difference|-3.3||||0.8768|2-Sided|95.0|-45.1|38.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648362|NCT01746901|3031669|Superiority or Other||LS Mean Difference|13.2||||0.5379|2-Sided|95.0|-29.0|55.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648363|NCT01746901|3031669|Superiority or Other||LS Mean Difference|55.2||||0.01|2-Sided|95.0|13.4|97.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648364|NCT01746901|3031669|Superiority or Other||LS Mean Difference|-45.3||||0.0354|2-Sided|95.0|-87.5|-3.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648365|NCT01746901|3031669|Superiority or Other||LS Mean Difference|3.9||||0.6551|2-Sided|95.0|-13.3|21.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648366|NCT01746901|3031669|Superiority or Other||LS Mean Difference|8.7||||0.3175|2-Sided|95.0|-8.5|25.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648367|NCT01746901|3031669|Superiority or Other||LS Mean Difference|4.6||||0.5965|2-Sided|95.0|-12.6|21.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648368|NCT01746901|3031669|Superiority or Other||LS Mean Difference|14.0||||0.1131|2-Sided|95.0|-3.3|31.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648369|NCT01746901|3031669|Superiority or Other||LS Mean Difference|11.7||||0.1789|2-Sided|95.0|-5.4|28.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648370|NCT01746901|3031669|Superiority or Other||LS Mean Difference|6.8||||0.4358|2-Sided|95.0|-10.5|24.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648371|NCT01746901|3031669|Superiority or Other||LS Mean Difference|4.0||||0.6423|2-Sided|95.0|-12.9|20.9|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648372|NCT01746901|3031669|Superiority or Other||LS Mean Difference|8.6||||0.3176|2-Sided|95.0|-8.3|25.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648373|NCT01746901|3031669|Superiority or Other||LS Mean Difference|3.8||||0.6595|2-Sided|95.0|-13.1|20.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648374|NCT01746901|3031669|Superiority or Other||LS Mean Difference|11.1||||0.2009|2-Sided|95.0|-6.0|28.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648375|NCT01746901|3031669|Superiority or Other||LS Mean Difference|11.1||||0.1949|2-Sided|95.0|-5.8|28.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648376|NCT01746901|3031669|Superiority or Other||LS Mean Difference|3.7||||0.6664|2-Sided|95.0|-13.3|20.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648377|NCT01746901|3031669|Superiority or Other||LS Mean Difference|2.2||||0.3457|2-Sided|95.0|-2.4|6.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648378|NCT01746901|3031669|Superiority or Other||LS Mean Difference|1.3||||0.5744|2-Sided|95.0|-3.2|5.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648379|NCT01746901|3031669|Superiority or Other||LS Mean Difference|-0.1||||0.9674|2-Sided|95.0|-4.6|4.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648380|NCT01746901|3031669|Superiority or Other||LS Mean Difference|2.1||||0.3641|2-Sided|95.0|-2.5|6.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648381|NCT01746901|3031669|Superiority or Other||LS Mean Difference|0.3||||0.8986|2-Sided|95.0|-4.2|4.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648696|NCT01741532|3032155|Superiority|||||||0.7279|||||||Mixed Models Analysis||||
1648697|NCT01741532|3032156|Superiority|||||||0.0761|||||||Mixed Models Analysis||||
1648382|NCT01746901|3031669|Superiority or Other||LS Mean Difference|1.7||||0.4585|2-Sided|95.0|-2.9|6.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648383|NCT01746901|3031669|Superiority or Other||LS Mean Difference|0.1||||0.9059|2-Sided|95.0|-1.1|1.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648384|NCT01746901|3031669|Superiority or Other||LS Mean Difference|0.3||||0.6125|2-Sided|95.0|-0.9|1.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648385|NCT01746901|3031669|Superiority or Other||LS Mean Difference|-0.5||||0.396|2-Sided|95.0|-1.7|0.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648386|NCT01746901|3031669|Superiority or Other||LS Mean Difference|0.8||||0.1778|2-Sided|95.0|-0.4|2.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648387|NCT01746901|3031669|Superiority or Other||LS Mean Difference|-0.5||||0.3944|2-Sided|95.0|-1.7|0.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648388|NCT01746901|3031669|Superiority or Other||LS Mean Difference|0.8||||0.1771|2-Sided|95.0|-0.4|2.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648389|NCT01746901|3031670|Superiority or Other||LS Mean Difference|2.2||||0.6524|2-Sided|95.0|-7.3|11.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648390|NCT01746901|3031670|Superiority or Other||LS Mean Difference|4.1||||0.3904|2-Sided|95.0|-5.3|13.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648391|NCT01746901|3031670|Superiority or Other||LS Mean Difference|-0.8||||0.8668|2-Sided|95.0|-10.3|8.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648392|NCT01746901|3031670|Superiority or Other||LS Mean Difference|11.4||||0.02|2-Sided|95.0|1.8|20.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648393|NCT01746901|3031670|Superiority or Other||LS Mean Difference|6.9||||0.1495|2-Sided|95.0|-2.5|16.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648394|NCT01746901|3031670|Superiority or Other||LS Mean Difference|3.6||||0.4555|2-Sided|95.0|-5.9|13.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648395|NCT01746901|3031671|Superiority or Other||LS Mean Difference|0.2||||0.8732|2-Sided|95.0|-2.1|2.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648396|NCT01746901|3031671|Superiority or Other||LS Mean Difference|1.7||||0.1331|2-Sided|95.0|-0.5|3.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648397|NCT01746901|3031671|Superiority or Other||LS Mean Difference|0.7||||0.5284|2-Sided|95.0|-1.5|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648398|NCT01746901|3031671|Superiority or Other||LS Mean Difference|0.7||||0.5483|2-Sided|95.0|-1.6|2.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648399|NCT01746901|3031671|Superiority or Other||LS Mean Difference|4.2||||0.0003|2-Sided|95.0|2.0|6.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648400|NCT01746901|3031671|Superiority or Other||LS Mean Difference|-2.8||||0.0129|2-Sided|95.0|-5.1|-0.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648401|NCT01746901|3031672|Superiority or Other||LS Mean Difference|11.7||||0.7945|2-Sided|95.0|-76.8|100.1|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648402|NCT01746901|3031672|Superiority or Other||LS Mean Difference|54.5||||0.2253|2-Sided|95.0|-33.9|142.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648403|NCT01746901|3031672|Superiority or Other||LS Mean Difference|30.4||||0.498|2-Sided|95.0|-58.0|118.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648404|NCT01746901|3031672|Superiority or Other||LS Mean Difference|52.5||||0.2423|2-Sided|95.0|-35.9|140.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648405|NCT01746901|3031672|Superiority or Other||LS Mean Difference|149.1||||0.0011|2-Sided|95.0|60.7|237.5|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648406|NCT01746901|3031672|Superiority or Other||LS Mean Difference|-66.2||||0.1415|2-Sided|95.0|-154.6|22.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648407|NCT01746901|3031672|Superiority or Other||LS Mean Difference|20.1||||0.5808|2-Sided|95.0|-51.6|91.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648408|NCT01746901|3031672|Superiority or Other||LS Mean Difference|55.0||||0.1314|2-Sided|95.0|-16.6|126.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648409|NCT01746901|3031672|Superiority or Other||LS Mean Difference|38.7||||0.2882|2-Sided|95.0|-33.0|110.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648410|NCT01746901|3031672|Superiority or Other||LS Mean Difference|53.2||||0.1449|2-Sided|95.0|-18.5|124.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648411|NCT01746901|3031672|Superiority or Other||LS Mean Difference|126.9||||0.0006|2-Sided|95.0|55.2|198.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648412|NCT01746901|3031672|Superiority or Other||LS Mean Difference|-35.0||||0.3362|2-Sided|95.0|-106.7|36.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648413|NCT01746901|3031672|Superiority or Other||LS Mean Difference|27.5||||0.171|2-Sided|95.0|-12.0|67.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648414|NCT01746901|3031672|Superiority or Other||LS Mean Difference|41.3||||0.0407|2-Sided|95.0|1.8|80.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648415|NCT01746901|3031672|Superiority or Other||LS Mean Difference|43.9||||0.0297|2-Sided|95.0|4.4|83.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648416|NCT01746901|3031672|Superiority or Other||LS Mean Difference|50.2||||0.0131|2-Sided|95.0|10.7|89.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648417|NCT01746901|3031672|Superiority or Other||LS Mean Difference|38.8||||0.0543|2-Sided|95.0|-0.7|78.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648418|NCT01746901|3031672|Superiority or Other||LS Mean Difference|55.3||||0.0064|2-Sided|95.0|15.8|94.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648419|NCT01746901|3031672|Superiority or Other||LS Mean Difference|26.9||||0.1074|2-Sided|95.0|-5.9|59.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648420|NCT01746901|3031672|Superiority or Other||LS Mean Difference|30.8||||0.0661|2-Sided|95.0|-2.1|63.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648421|NCT01746901|3031672|Superiority or Other||LS Mean Difference|35.7||||0.0335|2-Sided|95.0|2.8|68.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648422|NCT01746901|3031672|Superiority or Other||LS Mean Difference|43.9||||0.0091|2-Sided|95.0|11.1|76.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648423|NCT01746901|3031672|Superiority or Other||LS Mean Difference|19.7||||0.2365|2-Sided|95.0|-13.1|52.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648424|NCT01746901|3031672|Superiority or Other||LS Mean Difference|59.8||||0.0004|2-Sided|95.0|27.0|92.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648425|NCT01746901|3031672|Superiority or Other||LS Mean Difference|7.0||||0.1358|2-Sided|95.0|-2.2|16.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648426|NCT01746901|3031672|Superiority or Other||LS Mean Difference|7.9||||0.0934|2-Sided|95.0|-1.3|17.1|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648427|NCT01746901|3031672|Superiority or Other||LS Mean Difference|3.6||||0.4454|2-Sided|95.0|-5.6|12.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648428|NCT01746901|3031672|Superiority or Other||LS Mean Difference|12.3||||0.0094|2-Sided|95.0|3.1|21.5|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648429|NCT01746901|3031672|Superiority or Other||LS Mean Difference|1.1||||0.821|2-Sided|95.0|-8.1|10.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648430|NCT01746901|3031672|Superiority or Other||LS Mean Difference|14.8||||0.0019|2-Sided|95.0|5.6|24.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1649231|NCT01728454|3033791|Superiority|||||||0.3442|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle|
1648431|NCT01746901|3031672|Superiority or Other||LS Mean Difference|0.4||||0.7878|2-Sided|95.0|-2.6|3.5|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648432|NCT01746901|3031672|Superiority or Other||LS Mean Difference|3.4||||0.0289|2-Sided|95.0|0.4|6.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648433|NCT01746901|3031672|Superiority or Other||LS Mean Difference|0.3||||0.8382|2-Sided|95.0|-2.7|3.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648434|NCT01746901|3031672|Superiority or Other||LS Mean Difference|2.7||||0.0795|2-Sided|95.0|-0.3|5.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648435|NCT01746901|3031672|Superiority or Other||LS Mean Difference|-0.2||||0.8751|2-Sided|95.0|-3.3|2.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648436|NCT01746901|3031672|Superiority or Other||LS Mean Difference|3.3||||0.0351|2-Sided|95.0|0.2|6.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648437|NCT01746901|3031673|Superiority or Other||LS Mean Difference|10.8||||0.0982|2-Sided|95.0|-2.0|23.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648438|NCT01746901|3031673|Superiority or Other||LS Mean Difference|9.8||||0.1313|2-Sided|95.0|-3.0|22.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648439|NCT01746901|3031673|Superiority or Other||LS Mean Difference|11.1||||0.0901|2-Sided|95.0|-1.7|23.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648440|NCT01746901|3031673|Superiority or Other||LS Mean Difference|14.8||||0.0235|2-Sided|95.0|2.0|27.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648441|NCT01746901|3031673|Superiority or Other||LS Mean Difference|14.8||||0.0241|2-Sided|95.0|2.0|27.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648442|NCT01746901|3031673|Superiority or Other||LS Mean Difference|11.1||||0.0883|2-Sided|95.0|-1.7|23.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648443|NCT01746901|3031674|Superiority or Other||LS Mean Difference|-0.1||||0.8512|2-Sided|95.0|-1.6|1.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648444|NCT01746901|3031674|Superiority or Other||LS Mean Difference|-0.5||||0.5235|2-Sided|95.0|-1.9|1.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648445|NCT01746901|3031674|Superiority or Other||LS Mean Difference|-0.2||||0.7813|2-Sided|95.0|-1.6|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648446|NCT01746901|3031674|Superiority or Other||LS Mean Difference|-0.3||||0.7259|2-Sided|95.0|-1.7|1.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648447|NCT01746901|3031674|Superiority or Other||LS Mean Difference|1.9||||0.0105|2-Sided|95.0|0.4|3.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648448|NCT01746901|3031674|Superiority or Other||LS Mean Difference|-2.3||||0.0016|2-Sided|95.0|-3.7|-0.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648449|NCT01746901|3031675|Superiority or Other||LS Mean Difference|123.3||||0.0171|2-Sided|95.0|22.3|224.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648450|NCT01746901|3031675|Superiority or Other||LS Mean Difference|146.8||||0.0046|2-Sided|95.0|45.9|247.8|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648451|NCT01746901|3031675|Superiority or Other||LS Mean Difference|154.3||||0.003|2-Sided|95.0|53.3|255.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648452|NCT01746901|3031675|Superiority or Other||LS Mean Difference|200.7||||0.0001|2-Sided|95.0|99.7|301.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648453|NCT01746901|3031675|Superiority or Other||LS Mean Difference|145.7||||0.005|2-Sided|95.0|44.7|246.6|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648454|NCT01746901|3031675|Superiority or Other||LS Mean Difference|209.3|||<|0.0001|2-Sided|95.0|108.3|310.3|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648455|NCT01746901|3031675|Superiority or Other||LS Mean Difference|132.7|||<|0.0049|2-Sided|95.0|40.8|224.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648456|NCT01746901|3031675|Superiority or Other||LS Mean Difference|146.6|||<|0.0019|2-Sided|95.0|54.8|238.4|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648457|NCT01746901|3031675|Superiority or Other||LS Mean Difference|164.3|||<|0.0005|2-Sided|95.0|72.4|256.1|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648458|NCT01746901|3031675|Superiority or Other||LS Mean Difference|200.2|||<|0.0001|2-Sided|95.0|108.4|292.0|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648459|NCT01746901|3031675|Superiority or Other||LS Mean Difference|145.0|||<|0.0022|2-Sided|95.0|53.2|236.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648460|NCT01746901|3031675|Superiority or Other||LS Mean Difference|219.5|||<|0.0001|2-Sided|95.0|127.6|311.3|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648461|NCT01746901|3031675|Superiority or Other||LS Mean Difference|140.1|||<|0.0001|2-Sided|95.0|73.1|207.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648462|NCT01746901|3031675|Superiority or Other||LS Mean Difference|133.0|||<|0.0001|2-Sided|95.0|66.1|199.9|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648463|NCT01746901|3031675|Superiority or Other||LS Mean Difference|160.5|||<|0.0001|2-Sided|95.0|93.5|227.4|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648464|NCT01746901|3031675|Superiority or Other||LS Mean Difference|204.4|||<|0.0001|2-Sided|95.0|137.5|271.3|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648465|NCT01746901|3031675|Superiority or Other||LS Mean Difference|69.6|||<|0.0416|2-Sided|95.0|2.7|136.5|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648466|NCT01746901|3031675|Superiority or Other||LS Mean Difference|295.3|||<|0.0001|2-Sided|95.0|228.3|362.2|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648467|NCT01746901|3031675|Superiority or Other||LS Mean Difference|122.6|||<|0.0001|2-Sided|95.0|70.0|175.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648468|NCT01746901|3031675|Superiority or Other||LS Mean Difference|129.8|||<|0.0001|2-Sided|95.0|77.2|182.3|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648469|NCT01746901|3031675|Superiority or Other||LS Mean Difference|151.7|||<|0.0001|2-Sided|95.0|99.1|204.2|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648470|NCT01746901|3031675|Superiority or Other||LS Mean Difference|173.1|||<|0.0001|2-Sided|95.0|120.5|225.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648471|NCT01746901|3031675|Superiority or Other||LS Mean Difference|32.2|||<|0.2277|2-Sided|95.0|-20.3|84.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648472|NCT01746901|3031675|Superiority or Other||LS Mean Difference|292.5|||<|0.0001|2-Sided|95.0|240.0|345.1|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648473|NCT01746901|3031675|Superiority or Other||LS Mean Difference|53.0|||<|0.0001|2-Sided|95.0|36.0|70.1|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648474|NCT01746901|3031675|Superiority or Other||LS Mean Difference|54.3|||<|0.0001|2-Sided|95.0|37.3|71.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648475|NCT01746901|3031675|Superiority or Other||LS Mean Difference|68.4|||<|0.0001|2-Sided|95.0|51.3|85.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648476|NCT01746901|3031675|Superiority or Other||LS Mean Difference|43.6|||<|0.0001|2-Sided|95.0|26.6|60.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648477|NCT01746901|3031675|Superiority or Other||LS Mean Difference|7.3|||<|0.4003|2-Sided|95.0|-9.8|24.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648478|NCT01746901|3031675|Superiority or Other||LS Mean Difference|104.7|||<|0.0001|2-Sided|95.0|87.7|121.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648479|NCT01746901|3031675|Superiority or Other||LS Mean Difference|19.7|||<|0.0001|2-Sided|95.0|12.0|27.4|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1649232|NCT01728454|3033791|Superiority|||||||0.1253|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle|
1648480|NCT01746901|3031675|Superiority or Other||LS Mean Difference|20.5|||<|0.0001|2-Sided|95.0|12.8|28.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648481|NCT01746901|3031675|Superiority or Other||LS Mean Difference|27.4|||<|0.0001|2-Sided|95.0|19.7|35.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648482|NCT01746901|3031675|Superiority or Other||LS Mean Difference|16.4|||<|0.0001|2-Sided|95.0|8.7|24.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648483|NCT01746901|3031675|Superiority or Other||LS Mean Difference|4.3|||<|0.2739|2-Sided|95.0|-3.4|12.0|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648484|NCT01746901|3031675|Superiority or Other||LS Mean Difference|39.5|||<|0.0001|2-Sided|95.0|31.8|47.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648485|NCT01746901|3031676|Superiority or Other||LS Mean Difference|36.4|||<|0.0001|2-Sided|95.0|23.7|49.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648486|NCT01746901|3031676|Superiority or Other||LS Mean Difference|33.7|||<|0.0001|2-Sided|95.0|21.0|46.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648487|NCT01746901|3031676|Superiority or Other||LS Mean Difference|43.0|||<|0.0001|2-Sided|95.0|30.3|55.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648488|NCT01746901|3031676|Superiority or Other||LS Mean Difference|29.7|||<|0.0001|2-Sided|95.0|17.0|42.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648489|NCT01746901|3031676|Superiority or Other||LS Mean Difference|12.6|||<|0.0514|2-Sided|95.0|-0.1|25.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648490|NCT01746901|3031676|Superiority or Other||LS Mean Difference|60.1|||<|0.0001|2-Sided|95.0|47.4|72.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648491|NCT01746901|3031677|Superiority or Other||LS Mean Difference|0.1||||0.8757|2-Sided|95.0|-1.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648492|NCT01746901|3031677|Superiority or Other||LS Mean Difference|-0.2||||0.7295|2-Sided|95.0|-1.6|1.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648493|NCT01746901|3031677|Superiority or Other||LS Mean Difference|0.1||||0.844|2-Sided|95.0|-1.3|1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648494|NCT01746901|3031677|Superiority or Other||LS Mean Difference|-0.3||||0.7005|2-Sided|95.0|-1.7|1.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648495|NCT01746901|3031677|Superiority or Other||LS Mean Difference|2.8||||0.0001|2-Sided|95.0|1.4|4.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648496|NCT01746901|3031677|Superiority or Other||LS Mean Difference|-2.9|||<|0.0001|2-Sided|95.0|-4.3|-1.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648497|NCT01746901|3031678|Superiority or Other||LS Mean Difference|135.5||||0.0116|2-Sided|95.0|30.7|240.4|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648498|NCT01746901|3031678|Superiority or Other||LS Mean Difference|185.9||||0.0006|2-Sided|95.0|81.1|290.7|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648499|NCT01746901|3031678|Superiority or Other||LS Mean Difference|162.2||||0.0027|2-Sided|95.0|57.3|267.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648500|NCT01746901|3031678|Superiority or Other||LS Mean Difference|219.2|||<|0.0001|2-Sided|95.0|114.5|324.0|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648501|NCT01746901|3031678|Superiority or Other||LS Mean Difference|211.4|||<|0.0001|2-Sided|95.0|106.6|316.2|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648502|NCT01746901|3031678|Superiority or Other||LS Mean Difference|170.0|||<|0.0017|2-Sided|95.0|65.2|274.9|||Mixed Models Analysis|||AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648503|NCT01746901|3031678|Superiority or Other||LS Mean Difference|144.9|||<|0.0033|2-Sided|95.0|49.1|240.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648504|NCT01746901|3031678|Superiority or Other||LS Mean Difference|185.7|||<|0.0002|2-Sided|95.0|89.9|281.5|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648505|NCT01746901|3031678|Superiority or Other||LS Mean Difference|170.0|||<|0.0006|2-Sided|95.0|74.1|265.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648506|NCT01746901|3031678|Superiority or Other||LS Mean Difference|221.0|||<|0.0001|2-Sided|95.0|125.2|316.7|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648507|NCT01746901|3031678|Superiority or Other||LS Mean Difference|205.0|||<|0.0001|2-Sided|95.0|109.2|300.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648508|NCT01746901|3031678|Superiority or Other||LS Mean Difference|185.9|||<|0.0002|2-Sided|95.0|90.1|281.8|||Mixed Models Analysis|||AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648509|NCT01746901|3031678|Superiority or Other||LS Mean Difference|152.2|||<|0.0001|2-Sided|95.0|83.7|220.7|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648510|NCT01746901|3031678|Superiority or Other||LS Mean Difference|158.6|||<|0.0001|2-Sided|95.0|90.1|227.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648511|NCT01746901|3031678|Superiority or Other||LS Mean Difference|170.5|||<|0.0001|2-Sided|95.0|102.0|239.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648512|NCT01746901|3031678|Superiority or Other||LS Mean Difference|218.5|||<|0.0001|2-Sided|95.0|150.0|287.0|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648513|NCT01746901|3031678|Superiority or Other||LS Mean Difference|101.4|||<|0.004|2-Sided|95.0|32.9|169.8|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648514|NCT01746901|3031678|Superiority or Other||LS Mean Difference|287.6|||<|0.0001|2-Sided|95.0|219.1|356.1|||Mixed Models Analysis|||AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648515|NCT01746901|3031678|Superiority or Other||LS Mean Difference|135.7|||<|0.0001|2-Sided|95.0|81.7|189.6|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648516|NCT01746901|3031678|Superiority or Other||LS Mean Difference|141.9|||<|0.0001|2-Sided|95.0|87.9|195.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648517|NCT01746901|3031678|Superiority or Other||LS Mean Difference|162.0|||<|0.0001|2-Sided|95.0|108.0|216.0|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648518|NCT01746901|3031678|Superiority or Other||LS Mean Difference|188.5|||<|0.0001|2-Sided|95.0|134.6|242.5|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648519|NCT01746901|3031678|Superiority or Other||LS Mean Difference|47.8|||<|0.0824|2-Sided|95.0|-6.2|101.7|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648520|NCT01746901|3031678|Superiority or Other||LS Mean Difference|302.8|||<|0.0001|2-Sided|95.0|248.8|356.8|||Mixed Models Analysis|||AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648521|NCT01746901|3031678|Superiority or Other||LS Mean Difference|54.1|||<|0.0001|2-Sided|95.0|37.0|71.2|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648522|NCT01746901|3031678|Superiority or Other||LS Mean Difference|55.6|||<|0.0001|2-Sided|95.0|38.5|72.7|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648523|NCT01746901|3031678|Superiority or Other||LS Mean Difference|65.9|||<|0.0001|2-Sided|95.0|48.8|83.0|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648524|NCT01746901|3031678|Superiority or Other||LS Mean Difference|55.6|||<|0.0001|2-Sided|95.0|38.5|72.8|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648525|NCT01746901|3031678|Superiority or Other||LS Mean Difference|7.3|||<|0.3985|2-Sided|95.0|-9.8|24.4|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648526|NCT01746901|3031678|Superiority or Other||LS Mean Difference|114.2|||<|0.0001|2-Sided|95.0|97.1|131.3|||Mixed Models Analysis|||AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648527|NCT01746901|3031678|Superiority or Other||LS Mean Difference|18.9|||<|0.0001|2-Sided|95.0|11.0|26.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648528|NCT01746901|3031678|Superiority or Other||LS Mean Difference|20.2|||<|0.0001|2-Sided|95.0|12.3|28.1|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1649233|NCT01728454|3033792|Superiority|||||||0.0733|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle|
1648529|NCT01746901|3031678|Superiority or Other||LS Mean Difference|25.4|||<|0.0001|2-Sided|95.0|17.5|33.3|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648530|NCT01746901|3031678|Superiority or Other||LS Mean Difference|21.8|||<|0.0001|2-Sided|95.0|13.9|29.7|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648531|NCT01746901|3031678|Superiority or Other||LS Mean Difference|3.3|||<|0.4154|2-Sided|95.0|-4.6|11.2|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648532|NCT01746901|3031678|Superiority or Other||LS Mean Difference|43.9|||<|0.0001|2-Sided|95.0|36.0|51.8|||Mixed Models Analysis|||AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648533|NCT01746901|3031679|Superiority or Other||LS Mean Difference|38.4|||<|0.0001|2-Sided|95.0|26.0|50.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648534|NCT01746901|3031679|Superiority or Other||LS Mean Difference|73.6|||<|0.0001|2-Sided|95.0|61.1|86.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648535|NCT01746901|3031679|Superiority or Other||LS Mean Difference|47.2|||<|0.0001|2-Sided|95.0|34.8|59.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648536|NCT01746901|3031679|Superiority or Other||LS Mean Difference|32.9|||<|0.0001|2-Sided|95.0|20.5|45.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648537|NCT01746901|3031679|Superiority or Other||LS Mean Difference|18.8|||<|0.0032|2-Sided|95.0|6.4|31.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648538|NCT01746901|3031679|Superiority or Other||LS Mean Difference|61.2|||<|0.0001|2-Sided|95.0|48.8|73.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648539|NCT01746901|3031681|Superiority or Other||LS Mean Difference|8.5||||0.0775|2-Sided|95.0|-0.9|18.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648540|NCT01746901|3031681|Superiority or Other||LS Mean Difference|12.7||||0.0086|2-Sided|95.0|3.3|22.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648541|NCT01746901|3031681|Superiority or Other||LS Mean Difference|16.0||||0.0011|2-Sided|95.0|6.5|25.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648542|NCT01746901|3031681|Superiority or Other||LS Mean Difference|8.5||||0.0777|2-Sided|95.0|-1.0|18.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648543|NCT01746901|3031681|Superiority or Other||LS Mean Difference|-5.9||||0.2166|2-Sided|95.0|-15.4|3.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648544|NCT01746901|3031681|Superiority or Other||LS Mean Difference|30.4|||<|0.0001|2-Sided|95.0|21.0|39.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648545|NCT01746901|3031682|Superiority or Other||LS Mean Difference|10.8||||0.0172|2-Sided|95.0|1.9|19.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648546|NCT01746901|3031682|Superiority or Other||LS Mean Difference|14.5||||0.0014|2-Sided|95.0|5.7|23.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648547|NCT01746901|3031682|Superiority or Other||LS Mean Difference|19.8|||<|0.0001|2-Sided|95.0|11.0|28.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648548|NCT01746901|3031682|Superiority or Other||LS Mean Difference|7.8|||<|0.0841|2-Sided|95.0|-1.1|16.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648549|NCT01746901|3031682|Superiority or Other||LS Mean Difference|-2.4|||<|0.5951|2-Sided|95.0|-11.2|6.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648550|NCT01746901|3031682|Superiority or Other||LS Mean Difference|29.9|||<|0.0001|2-Sided|95.0|21.1|38.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648551|NCT01746901|3031683|Superiority or Other||LS Mean Difference|13.3||||0.0036|2-Sided|95.0|4.4|22.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648552|NCT01746901|3031683|Superiority or Other||LS Mean Difference|16.6||||0.0003|2-Sided|95.0|7.7|25.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648553|NCT01746901|3031683|Superiority or Other||LS Mean Difference|23.2|||<|0.0001|2-Sided|95.0|14.4|32.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1649234|NCT01728454|3033792|Superiority|||||||0.114|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle|
1648554|NCT01746901|3031683|Superiority or Other||LS Mean Difference|7.5|||<|0.0997|2-Sided|95.0|-1.4|16.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648555|NCT01746901|3031683|Superiority or Other||LS Mean Difference|2.2|||<|0.6209|2-Sided|95.0|-6.7|11.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648556|NCT01746901|3031683|Superiority or Other||LS Mean Difference|28.5|||<|0.0001|2-Sided|95.0|19.6|37.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648557|NCT01746901|3031685|Superiority or Other||LS Mean Difference|9.5||||0.1136|2-Sided|95.0|-2.3|21.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648558|NCT01746901|3031685|Superiority or Other||LS Mean Difference|22.4||||0.0002|2-Sided|95.0|10.6|34.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648559|NCT01746901|3031685|Superiority or Other||LS Mean Difference|9.5||||0.1136|2-Sided|95.0|-2.3|21.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648560|NCT01746901|3031685|Superiority or Other||LS Mean Difference|8.7||||0.1471|2-Sided|95.0|-3.1|20.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648561|NCT01746901|3031685|Superiority or Other||LS Mean Difference|-3.2||||0.5968|2-Sided|95.0|-14.9|8.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648562|NCT01746901|3031685|Superiority or Other||LS Mean Difference|36.9|||<|0.0001|2-Sided|95.0|25.2|48.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648563|NCT01746901|3031686|Superiority or Other||LS Mean Difference|11.5||||0.0408|2-Sided|95.0|0.5|22.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648564|NCT01746901|3031686|Superiority or Other||LS Mean Difference|23.2|||<|0.0001|2-Sided|95.0|12.3|34.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648565|NCT01746901|3031686|Superiority or Other||LS Mean Difference|25.9|||<|0.0001|2-Sided|95.0|14.9|36.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648566|NCT01746901|3031686|Superiority or Other||LS Mean Difference|9.0|||<|0.1083|2-Sided|95.0|-2.0|19.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648567|NCT01746901|3031686|Superiority or Other||LS Mean Difference|-0.1|||<|0.9811|2-Sided|95.0|-11.1|10.8|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648568|NCT01746901|3031686|Superiority or Other||LS Mean Difference|35.0|||<|0.0001|2-Sided|95.0|24.0|46.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648569|NCT01746901|3031687|Superiority or Other||LS Mean Difference|11.9||||0.0335|2-Sided|95.0|0.9|22.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648570|NCT01746901|3031687|Superiority or Other||LS Mean Difference|25.7|||<|0.0001|2-Sided|95.0|14.7|36.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648571|NCT01746901|3031687|Superiority or Other||LS Mean Difference|26.3|||<|0.0001|2-Sided|95.0|15.4|37.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648572|NCT01746901|3031687|Superiority or Other||LS Mean Difference|9.0|||<|0.1072|2-Sided|95.0|-2.0|20.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648573|NCT01746901|3031687|Superiority or Other||LS Mean Difference|2.6|||<|0.6434|2-Sided|95.0|-8.4|13.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648574|NCT01746901|3031687|Superiority or Other||LS Mean Difference|32.8|||<|0.0001|2-Sided|95.0|21.8|43.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648575|NCT01746901|3031688|Superiority or Other||LS Mean Difference|52.6|||<|0.0001|2-Sided|95.0|36.2|69.0|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648576|NCT01746901|3031688|Superiority or Other||LS Mean Difference|56.7|||<|0.0001|2-Sided|95.0|40.3|73.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648577|NCT01746901|3031688|Superiority or Other||LS Mean Difference|68.8|||<|0.0001|2-Sided|95.0|52.4|85.2|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648578|NCT01746901|3031688|Superiority or Other||LS Mean Difference|46.1|||<|0.0001|2-Sided|95.0|29.6|62.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1649235|NCT01728454|3033793|Superiority|||||||0.1636|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle|
1649236|NCT01728454|3033793|Superiority|||||||0.114|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle|
1648579|NCT01746901|3031688|Superiority or Other||LS Mean Difference|6.8|||<|0.4125|2-Sided|95.0|-9.6|23.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648580|NCT01746901|3031688|Superiority or Other||LS Mean Difference|108.0|||<|0.0001|2-Sided|95.0|91.6|124.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648581|NCT01746901|3031689|Superiority or Other||LS Mean Difference|36.3|||<|0.0001|2-Sided|95.0|24.6|48.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648582|NCT01746901|3031689|Superiority or Other||LS Mean Difference|32.1|||<|0.0001|2-Sided|95.0|20.3|43.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648583|NCT01746901|3031689|Superiority or Other||LS Mean Difference|42.6|||<|0.0001|2-Sided|95.0|30.9|54.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648584|NCT01746901|3031689|Superiority or Other||LS Mean Difference|32.9|||<|0.0001|2-Sided|95.0|21.1|44.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648585|NCT01746901|3031689|Superiority or Other||LS Mean Difference|12.3|||<|0.0402|2-Sided|95.0|0.6|24.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648586|NCT01746901|3031689|Superiority or Other||LS Mean Difference|63.2|||<|0.0001|2-Sided|95.0|51.5|74.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648587|NCT01746901|3031690|Superiority or Other||LS Mean Difference|18.2||||0.0005|2-Sided|95.0|8.1|28.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648588|NCT01746901|3031690|Superiority or Other||LS Mean Difference|23.0|||<|0.0001|2-Sided|95.0|12.8|33.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648589|NCT01746901|3031690|Superiority or Other||LS Mean Difference|27.1|||<|0.0001|2-Sided|95.0|17.0|37.3|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648590|NCT01746901|3031690|Superiority or Other||LS Mean Difference|22.2|||<|0.0001|2-Sided|95.0|12.1|32.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648591|NCT01746901|3031690|Superiority or Other||LS Mean Difference|0.0|||<|0.9994|2-Sided|95.0|-10.1|10.1|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648592|NCT01746901|3031690|Superiority or Other||LS Mean Difference|49.3|||<|0.0001|2-Sided|95.0|39.2|59.5|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648593|NCT01746901|3031691|Superiority or Other||LS Mean Difference|18.5||||18.5|2-Sided|95.0|12.5|24.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648594|NCT01746901|3031691|Superiority or Other||LS Mean Difference|15.3|||<|0.0001|2-Sided|95.0|9.3|21.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648595|NCT01746901|3031691|Superiority or Other||LS Mean Difference|22.9|||<|0.0001|2-Sided|95.0|16.8|28.9|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648596|NCT01746901|3031691|Superiority or Other||LS Mean Difference|15.3|||<|0.0001|2-Sided|95.0|9.3|21.4|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648597|NCT01746901|3031691|Superiority or Other||LS Mean Difference|7.7|||<|0.0132|2-Sided|95.0|1.6|13.7|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648598|NCT01746901|3031691|Superiority or Other||Least Squares (LS) Mean Difference|30.5|||<|0.0001|2-Sided|95.0|24.4|36.6|||Mixed Models Analysis|||Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.|
1648599|NCT01746862|3031699|Superiority or Other||Least Squares (LS) Mean Difference|3.47|||<|0.0001|2-Sided|95.0|2.17|4.78|||ANCOVA|Analysis was performed using analysis of covariance (ANCOVA) with baseline age and baseline height as the covariates.|||
1648600|NCT01746264|3031733|Superiority or Other|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.|
1648601|NCT01746264|3031734|Superiority or Other|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.|
1648602|NCT01746264|3031735|Superiority or Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.|
1648603|NCT01746264|3031736|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.|
1648604|NCT01746264|3031737|Superiority or Other|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.|
1648605|NCT01746264|3031738|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.|
1648606|NCT01746264|3031739|Superiority or Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.|
1648607|NCT01746264|3031740|Superiority or Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Change from baseline to 3 month follow-up.|
1649237|NCT01728454|3033794|Superiority|||||||0.2354|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle|
1648615|NCT01746225|3031754|Superiority|||||||0.2||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS>7 months.|
1648616|NCT01746225|3031754|Superiority|||||||0.03||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS>7 months.|
1648617|NCT01746225|3031754|Superiority|||||||0.12||||||Not adjusted for multiple comparisons; One-sided .05 alpha-level test|Log Rank|One-sided test||For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS>7 months.|
1648618|NCT01745952|3031795|Superiority or Other|||||||0.9819|||||||negative binomial model + overdispersion||||
1648619|NCT01745146|3031826|Equivalence|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.332||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's Chi-squared||Significance of difference in overall post-treatment response rate. Missing outcomes excluded for this analysis.|
1648620|NCT01745146|3031826|Equivalence|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.421||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's Chi-squared||Significance of difference in overall post-treatment response rate. Missing outcomes included as non-responders.|
1648621|NCT01745146|3031826|Equivalence|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.53||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for BAAQ. Missing outcomes excluded for this analysis.|
1648622|NCT01745146|3031826|Equivalence|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.483||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes excluded for this analysis.|
1648623|NCT01745146|3031826|Equivalence|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.031||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes excluded for this analysis.|
1648624|NCT01745146|3031826|Equivalence|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.511||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for BAAQ. Missing outcomes reported at non-responders.|
1648625|NCT01745146|3031826|Equivalence|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.549||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Anger Expression-Out. Missing outcomes reported at non-responders.|
1648626|NCT01745146|3031826|Equivalence|Primary outcome is difference in rates of treatment response between the ASMT and the PRE, where treatment response is defined as ≥ 1 SD improvement in self-reported anger on at least 1 of 3 target scales from pre- to 1-2 wk post treatment. The treatment will be considered supported if the observed response rate with ASMT is at least 20 percentage points higher than that with the control treatment, PRE.||||||0.047||||||Alpha was set at .05 both for the a priori hypotheses and also for secondary analyses|Chi-squared|Pearson's chi-square test||Significance of difference in post-treatment response rate for STAXI-2 Trait Anger. Missing outcomes reported at non-responders.|
1648627|NCT01745055|3031872|Superiority or Other||Ratio of Adjusted Geometric Means|87.25|||||2-Sided|90.0|76.03|100.12||||||Natural log transformed, Cmax of MTX was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1648778|NCT01737710|3032637|Superiority or Other||Odds Ratio (OR)|1.8||||0.082|2-Sided|95.0|0.92|3.55||Null hypothesis: no difference in the percent of participants that were seroprotected against influenza B at Day 28 between the two groups.|Fisher Exact||||
1648628|NCT01745055|3031873|Superiority or Other||Ratio of Adjusted Geometric Means|89.53|||||2-Sided|90.0|77.38|103.57||||||Natural log transformed, AUClast of MTX was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1648629|NCT01745055|3031874|Superiority or Other||Ratio of Adjusted Geometric Means|102.71|||||2-Sided|90.0|93.79|112.47||||||Natural log transformed, Cmax of CP-690,550 was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1648630|NCT01745055|3031875|Superiority or Other||Ratio of Adjusted Geometric Means|103.06|||||2-Sided|90.0|99.0|107.29||||||Natural log transformed, AUC (0-12) of CP-690,550 was analyzed using mixed effect model with treatment as fixed effects and participant as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1648631|NCT01744977|3031876|Non-Inferiority or Equivalence|With an assumed adherence proportion in the Control arm of 0.50, there is 80% power to detect a difference between Control and the intervention arms of 17% or more with 125 patients in each arm.|Mean Difference (Final Values)|-0.7||||0.839|2-Sided|95.0|-8.0|6.5||As measured at 12m|Mixed Models Analysis||This value summarizes the full 12 month period so Mean Difference (Final Values) is appropriate.||
1648632|NCT01744977|3031877|Non-Inferiority or Equivalence|With an assumed adherence proportion in the Control arm of 0.50, there is 80% power to detect a difference between Control and the intervention arms of 17% or more with 125 patients in each arm.||||||0.3|||||||Wilcoxon (Mann-Whitney)||||
1648633|NCT01744860|3031906|Superiority or Other||Kappa coefficient|0.8611|||||2-Sided|95.0|0.8125|0.9097||||||Kappa coefficient was used to compare the concordance between INCa Molecular Genetics Laboratory “in-house” methods and Cobas 4800 Mutation Test.|
1648634|NCT01744496|3031952|Superiority or Other||Least Square Mean|-2.82|Standard Error of the Mean|2.97||0.346|2-Sided|95.0|-8.76|3.13|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.|||
1648635|NCT01744496|3031953|Superiority or Other||Least Square Mean|-0.58|Standard Error of the Mean|0.64||0.371|2-Sided|95.0|-1.85|0.7|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.|||
1648636|NCT01744496|3031954|Superiority or Other||Least Square Mean|-1.02|Standard Error of the Mean|0.87||0.247|2-Sided|95.0|-2.76|0.73|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.|||
1648637|NCT01744496|3031955|Superiority or Other||Least Square Mean|-8.01|Standard Error of the Mean|3.77||0.038|2-Sided|95.0|-15.56|-0.46|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.|||
1648638|NCT01744496|3031957|Superiority or Other||Least Square Mean|-0.76|Standard Error of the Mean|0.55||0.172|2-Sided|95.0|-1.87|0.34|||ANCOVA|ANCOVA model for the change from Baseline to the End of Treatment containing treatment and region as factors and Baseline value as a covariate.|||
1648639|NCT01744392|3031967|Superiority or Other||Mean Difference (Final Values)|3.2||||0.73|2-Sided||||||t-test, 2 sided|||Difference between percentages. Increases in value indicate improvement in adherence.|
1648640|NCT01743729|3031992|Superiority or Other||Treatment Effect|12.61|||<|0.0001|2-Sided|95.0|8.51|16.7|||ANCOVA||||
1648641|NCT01743729|3031993|Superiority or Other||Treatment Effect|0.03||||0.6186|2-Sided|95.0|-0.1|0.17|||ANCOVA||||
1648642|NCT01743469|3032028|Superiority or Other|||||||0.5||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with a prespecified threshold (>20%).|
1648643|NCT01743469|3032029|Superiority or Other|||||||0.63||||||One-sided alpha of 0.1|Exact binomial test|||The PFS rate was compared with the prespecified threshold (>15%).|
1648644|NCT01743469|3032029|Superiority or Other|||||||0.8||||||One-sided alpha of 0.1|Exact binomial test|||The PFS rate was compared with the prespecified threshold (>20%).|
1648645|NCT01743469|3032029|Superiority or Other|||||||1||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with the prespecified threshold (>35%).|
1648646|NCT01743469|3032029|Superiority or Other|||||||0.142||||||One-sided alpha of 0.1.|Exact binomial test|||The PFS rate was compared with the prespecified threshold (>20%).|
1648647|NCT01743001|3032040|Superiority||least-square (LS) mean difference|-1.1||||0.3416|2-Sided|95.0|-3.4|1.2|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the Mental Component Summary Score.|
1648648|NCT01743001|3032040|Superiority||least-square (LS) mean difference|0.7||||0.4332|2-Sided|95.0|-1.0|2.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the Physical Component Summary Score.|
1648649|NCT01743001|3032040|Superiority||least-square (LS) mean difference|-1.3||||0.2704|2-Sided|95.0|-3.6|1.0|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Mental Health Index.|
1648650|NCT01743001|3032040|Superiority||least-square (LS) mean difference|-1.3||||0.3384|2-Sided|95.0|-4.1|1.4|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Emotional (norm-based).|
1648779|NCT01737684|3032649|Superiority or Other||Geometric least-squares mean ratio|1.35|||||2-Sided|90.0|0.88|2.06|||||||
1648651|NCT01743001|3032040|Superiority||least-square (LS) mean difference|-0.6||||0.634|2-Sided|95.0|-3.1|1.9|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Social Functioning (norm-based).|
1648652|NCT01743001|3032040|Superiority||least-square (LS) mean difference|0.6||||0.602|2-Sided|95.0|-1.5|2.6|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Vitality (norm-based).|
1648653|NCT01743001|3032040|Superiority||least-square (LS) mean difference|1.5||||0.1542|2-Sided|95.0|-0.6|3.5|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of General Health Perceptions (norm-based).|
1648654|NCT01743001|3032040|Superiority||least-square (LS) mean difference|0.1||||0.9642|2-Sided|95.0|-2.5|2.6|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Pain Index (norm-based).|
1648655|NCT01743001|3032040|Superiority||least-square (LS) mean difference|-0.6||||0.5988|2-Sided|95.0|-2.6|1.5|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Physical (norm-based).|
1648656|NCT01743001|3032040|Superiority||least-square (LS) mean difference|-0.4||||0.6431|2-Sided|95.0|-2.1|1.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Physical Functioning (norm-based).|
1648657|NCT01743001|3032040|Superiority||least-square (LS) mean difference|-2.3||||0.2704|2-Sided|95.0|-6.4|1.8|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Mental Health Index.|
1648658|NCT01743001|3032040|Superiority||least-square (LS) mean difference|-2.8||||0.3384|2-Sided|95.0|-8.7|3.0|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Emotional.|
1648659|NCT01743001|3032040|Superiority||least-square (LS) mean difference|-1.4||||0.634|2-Sided|95.0|-7.2|4.4|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Social Functioning.|
1648660|NCT01743001|3032040|Superiority||least-square (LS) mean difference|1.1||||0.602|2-Sided|95.0|-3.1|5.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Vitality.|
1648661|NCT01743001|3032040|Superiority||least-square (LS) mean difference|3.1||||0.1542|2-Sided|95.0|-1.2|7.3|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of General Health Perceptions.|
1648662|NCT01743001|3032040|Superiority||least-square (LS) mean difference|0.1||||0.9642|2-Sided|95.0|-5.9|6.2|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Pain Index.|
1648663|NCT01743001|3032040|Superiority||least-square (LS) mean difference|-1.4||||0.5988|2-Sided|95.0|-6.7|3.9|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Role-Physical.|
1648664|NCT01743001|3032040|Superiority||least-square (LS) mean difference|-1.0||||0.6431|2-Sided|95.0|-5.0|3.1|||ANCOVA|Adjusted for randomized treatment group, location of cardiac defect (pre-tricupsid/post-tricupsid) as factors and baseline scores as covariates.||The null hypothesis is that the mean change from baseline to Week 16 is the same in the macitentan and the placebo group for the SF-36 domain score of Physical Functioning.|
1648665|NCT01743001|3032041|Superiority||least-square (LS) mean difference|0.08||||0.6818||95.0|-0.29|0.44||The secondary efficacy endpoints were analyzed hierarchically as this approach eliminated the requirement for further adjustment for multiple comparisons.|ANCOVA|Adjusted for randomized treatment group, location of cardiac defect(pre-tricupsid/post-tricupsid) as factors, baseline Borg dyspnea index as covariate||The null hypothesis was that the mean change from baseline to Week 16 in the Borg dyspnea index is the same in the macitentan and in the placebo group.|
1648698|NCT01740427|3032287|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.325||||0.7822|2-Sided|95.0|-2.63|1.98|||Mixed Models Analysis|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||
1648780|NCT01737684|3032652|Superiority or Other||Geometric least-squares mean ratio|1.27|||||2-Sided|90.0|0.96|1.67|||||||
1649238|NCT01728454|3033794|Superiority|||||||0.478|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle|
1648666|NCT01743001|3032042|Superiority||Odds Ratio (OR)|0.53||||0.145|2-Sided|95.0|0.23|1.24||The secondary efficacy endpoints were analyzed hierarchically as this approach eliminated the requirement for further adjustment for multiple comparisons.|Regression, Logistic|Logistic regression model adjusted for randomized treatment group and location of cardiac defect (pre-tricupsid / post-tricupsid ) as factors.||For this secondary endpoint of WHO functional class, the improvement from baseline to Week 16 in WHO functional class was evaluated. The null hypothesis is the odds of improvement are the same in the placebo and the macitentan group.|
1648667|NCT01743001|3032043|Superiority||least-square (LS) mean difference|-4.7||||0.612|2-Sided|95.0|-22.8|13.5||To control for multiplicity across the primary and secondary endpoints, all secondary endpoints were analyzed hierarchically according to order and significance as pre-specified in the protocol eliminating further adjustment for multiple comparisons.|ANCOVA|ANCOVA model included treatment group, presence of DS (yes/no), and WHO FC (II vs III/IV) as categorical factors, and baseline 6MWD value as covariate||The null hypothesis was that there was no difference between macitentan and placebo for the mean change from baseline to Week 16 in 6MWD. Null hypothesis was tested by an analysis of covariance (ANCOVA).|
1648668|NCT01742832|3032054|Other|Linear repeated measures regression models were constructed to assess trends over time between groups where the dependent variable was outcome measure (MADRS score) and independent variables included visit, treatment group, visit by treatment group interaction, and any baseline variables that were significant between groups.||||||0.342||||||P-value for linear regression assessing outcome measure (MADRS score) and treatment group.|Regression, Linear||||
1648669|NCT01742364|3032055|Superiority or Other|||||||0.003|||||||Chi-squared||||
1648670|NCT01742364|3032055|Superiority or Other|||||||0.001|||||||Chi-squared||||
1648671|NCT01742364|3032056|Superiority or Other|||||||0.13|||||||Kruskal-Wallis||||
1648672|NCT01742364|3032056|Superiority or Other|||||||0.001|||||||Kruskal-Wallis||||
1648673|NCT01742364|3032057|Superiority or Other|||||||0.325|||||||Wilcoxon (Mann-Whitney)||||
1648674|NCT01742364|3032058|Superiority or Other|||||||0.205|||||||Wilcoxon (Mann-Whitney)||||
1648675|NCT01742364|3032060|Superiority or Other|||||||0.187|||||||Fisher Exact|||Comparison of all adverse events (both injection site and systemic AEs).|
1648676|NCT01742364|3032060|Superiority or Other|||||||0.475|||||||Fisher Exact|||Comparison of all adverse events (both injection site and systemic AEs).|
1648677|NCT01742208|3032067|Superiority||LS Mean Difference|-25.14||||0.007|2-Sided|95.0|-42.78|-7.49||Threshold for significance at 0.05 level.|ANCOVA||Difference is sotagliflozin – placebo|Between-group comparison of the 2 Expansion Groups was based on an ANCOVA model with covariates of baseline mean total daily bolus insulin, treatment group, factor used to stratify the randomization (screening A1C <= 8%, > 8%), and random effect of participant*treatment group.|
1648678|NCT01742065|3032078|Other|To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic's data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclass correlation coefficient was 0.05 after covariable adjustment.|Mean Difference (Final Values)|3.8||||0.02|2-Sided|95.0|0.6|7.0||We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;|Generalized Estimating Equations (GEE)|Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.|||
1648679|NCT01742065|3032079|Superiority|To assess effectiveness, we fit generalized estimating equations (GEE) with a logistic link to model patient-level data. We weighted patient data so that each clinic’s data had an equal weight. Models were adjusted for age, sex, and health center. They used robust variance estimators and independent correlation structures. We specified clinic as a clustering variable to account for intraclinic correlation; the intraclinic correlation coefficient was 0.05 after model covariates adjustment.|Mean Difference (Final Values)|3.4||||0.05|2-Sided|95.0|0.1|6.8||We report effectiveness as the absolute difference between intervention and usual care clinics in adjusted probabilities calculated using mean values for all covariates;|Generalized Estimating Equations (GEE)|Reported P values based on the corresponding adjusted odds ratio and account for reduced degrees of freedom owing to clustering.|||
1648680|NCT01741701|3032118|Superiority or Other|||||||0.95|||||||t-test, 2 sided|||Comparison between groups in change from baseline to 4 months|
1648681|NCT01741701|3032119|Superiority or Other|||||||0.9|||||||t-test, 2 sided|||Comparison between groups in change from baseline to 4 months|
1648682|NCT01741701|3032120|Superiority or Other|||||||0.77|||||||t-test, 2 sided|||Comparison between groups in the change from baseline to 4 months|
1648683|NCT01741701|3032121|Superiority or Other|||||||0.97|||||||t-test, 2 sided|||Comparison between groups in the change from baseline to 4 months|
1648684|NCT01741701|3032122|Superiority or Other|||||||0.51|||||||t-test, 2 sided|||Comparison of change between groups from baseline to 4 months|
1648685|NCT01741701|3032123|Superiority or Other|||||||0.5|||||||t-test, 2 sided||||
1648686|NCT01741532|3032149|Superiority|||||||0|||||||Mixed Models Analysis||||
1648687|NCT01741532|3032150|Superiority|||||||0.6323|||||||Mixed Models Analysis||||
1648688|NCT01741532|3032151|Superiority|||||||0.5781|||||||Mixed Models Analysis|||Parent proxy-report, total score|
1648689|NCT01741532|3032151|Superiority|||||||0.9759|||||||Mixed Models Analysis|||Patient self-report, total score|
1648690|NCT01741532|3032152|Superiority|||||||0.2026|||||||Mixed Models Analysis||||
1648691|NCT01741532|3032153|Superiority|||||||0.1524|||||||Mixed Models Analysis||||
1648692|NCT01741532|3032154|Superiority|||||||0.1749|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part VI|
1648693|NCT01741532|3032154|Superiority|||||||0.2182|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part III|
1648694|NCT01741532|3032154|Superiority|||||||0.3677|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part II|
1648695|NCT01741532|3032154|Superiority|||||||0.7228|||||||Mixed Models Analysis|||Comparison of treatment groups on change in score on UPDRS Part I|
1648699|NCT01740427|3032288|Superiority or Other (legacy)||Mean Difference (Final Values)|0.023||||0.0925|2-Sided|95.0|-0.004|0.051|||Mixed Models Analysis|Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||
1648700|NCT01740427|3032292|Superiority or Other (legacy)||Hazard Ratio (HR)|0.569||||0.0007|2-Sided|95.0|0.409|0.791|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Ki67 >20%|
1648701|NCT01740427|3032292|Superiority or Other (legacy)||Hazard Ratio (HR)|0.53||||0.0002|2-Sided|95.0|0.379|0.742|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Ki67 ≤20%|
1648702|NCT01740427|3032292|Superiority or Other (legacy)||Hazard Ratio (HR)|0.255||||0.0022|2-Sided|95.0|0.1|0.65|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 HScore≥175|
1648703|NCT01740427|3032292|Superiority or Other (legacy)||Hazard Ratio (HR)|0.581|||<|0.0001|2-Sided|95.0|0.455|0.742|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 HScore<175|
1648704|NCT01740427|3032292|Superiority or Other (legacy)||Hazard Ratio (HR)|0.731|||<|0.3221|2-Sided|95.0|0.392|1.364|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 Negative|
1648705|NCT01740427|3032292|Superiority or Other (legacy)||Hazard Ratio (HR)|0.518|||<|0.0001|2-Sided|95.0|0.4|0.67|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for p16 Positive|
1648706|NCT01740427|3032292|Superiority or Other (legacy)||Hazard Ratio (HR)|0.997|||<|0.9964|2-Sided|95.0|0.287|3.461|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Cyclin D1 Negative|
1648707|NCT01740427|3032292|Superiority or Other (legacy)||Hazard Ratio (HR)|0.555|||<|0.0001|2-Sided|95.0|0.437|0.705|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Cyclin D1 Positive|
1648708|NCT01740427|3032292|Superiority or Other (legacy)||Hazard Ratio (HR)|0.675|||<|0.3237|2-Sided|95.0|0.308|1.481|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Rb Negative|
1648709|NCT01740427|3032292|Superiority or Other (legacy)||Hazard Ratio (HR)|0.531|||<|0.0001|2-Sided|95.0|0.416|0.68|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for Rb Positive|
1648710|NCT01740427|3032292|Superiority or Other (legacy)||Hazard Ratio (HR)|0.405|||<|0.003|2-Sided|95.0|0.218|0.751|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for ER Negative|
1648711|NCT01740427|3032292|Superiority or Other (legacy)||Hazard Ratio (HR)|0.571|||<|0.0001|2-Sided|95.0|0.443|0.737|||Unstratified log-rank test||Unstratified Cox proportional hazards model was used.|Statistical analysis for ER positive|
1648712|NCT01740427|3032293|Superiority or Other (legacy)||Odds Ratio (OR)|2.451|||<|0.0001|2-Sided|95.0|1.619|3.722||1-sided p-value is from exact test.|Fisher Exact||An Odds Ratio > 1 means better response in favor of palbociclib plus letrozole arm.|Stratified analysis: Stratified by disease site (visceral, non-visceral) per randomization.|
1648713|NCT01740427|3032295|Superiority or Other (legacy)||Odds Ratio (OR)|1.594||||0.009|2-Sided|95.0|1.08|2.347||1-sided p-value is from exact test.|Fisher Exact||An Odds Ratio >1 means better response in favor of the palbociclib plus letrozole arm.|Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.|
1648714|NCT01740427|3032296|Superiority or Other (legacy)||Odds Ratio (OR)|1.428||||0.0224|2-Sided|95.0|1.008|2.03||1-sided p-value is from exact test.|Fisher Exact||An Odds Ratio >1 means better response in favor of the palbociclib plus letrozole arm.|Stratified analysis: Stratified by disease site (visceral vs non-visceral) per randomization.|
1648715|NCT01740427|3032297|Superiority or Other (legacy)||Hazard Ratio (HR)|0.576|||<|1e-06|2-Sided|95.0|0.463|0.718||1-sided p-value from the stratified log-rank test.|Stratified Log Rank||Assuming proportional hazards, a hazard ratio of less than 1 indicates a risk reduction in favor of palbociclib plus letrozole.||
1648716|NCT01740362|3032314|Superiority or Other||Ratio of adjusted geometric mean|117.65|||||2-Sided|95.0|84.91|163.02||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 [severe renal insufficiency] - CP-690,550 [normal renal function]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.|
1648717|NCT01740362|3032314|Superiority or Other||Ratio of adjusted geometric mean|104.17|||||2-Sided|90.0|75.18|144.34||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 [moderate renal insufficiency] - CP-690,550 [normal renal function]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.|
1648718|NCT01740362|3032314|Superiority or Other||Ratio of adjusted geometric mean|93.15|||||2-Sided|90.0|67.22|129.06||||||One way ANOVA on natural log-transformed Cmax were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 [mild renal insufficiency] - CP-690,550 [normal renal function]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.|
1648719|NCT01740362|3032315|Superiority or Other||Ratio of adjusted geometric means|222.71|||||2-Sided|90.0|157.02|315.89||||||One way ANOVA on natural log-transformed AUC (0 - ∞) were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 [severe renal insufficiency] - CP-690,550 [normal renal function]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.|
1648752|NCT01738672|3032510|Other|||||||0.56|||||||t-test, 2 sided||||
1648753|NCT01738672|3032511|Other|||||||0.73|||||||t-test, 2 sided||||
1648754|NCT01738672|3032512|Other|||||||0.16|||||||t-test, 2 sided||||
1648781|NCT01737398|3032678|Other||Least Square Mean Difference|-11.68||||0.0006|2-Sided|95.0|-18.29|-5.06|||MMRM||||
1648720|NCT01740362|3032315|Superiority or Other||Ratio of adjusted geometric means|142.59|||||2-Sided|90.0|100.53|202.24||||||One way ANOVA on natural log-transformed AUC (0 - ∞) were analyzed using linear model containing degrees of renal impairment (CLcr, discrete) calculated using blood samples collected at screening as fixed effects. SAS procedure PROC MIXED was used for analysis. Anti-log of the adjusted mean difference (CP-690,550 [moderate renal insufficiency] - CP-690,550 [normal renal function]) and its corresponding 90% CI were taken to estimate the mean ratio and corresponding 90% CI.|
1648721|NCT01740362|3032315|Superiority or Other||Ratio of adjusted geometric means|137.26|||||2-Sided|90.0|96.77|194.69||||||1 way Analysis of Variance (ANOVA) on natural log-transformed AUC(0-∞) analyzed using linear model with degrees of renal impairment(creatinine clearance[CLcr, discrete]) evaluated using blood samples collected at screening as fixed effect. Statistical Analysis System (SAS) mixed procedure (PROC MIXED) was used. Anti-log of adjusted mean difference (CP-690,550[mild renal insufficiency] - CP-690,550[normal renal function]), 90% confidence interval (CI) were taken to estimate mean ratio and 90% CI.|
1648722|NCT01740297|3032325|Other||Hazard Ratio (HR)|0.8||||0.474|2-Sided|95.0|0.44|1.46|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model||
1648723|NCT01740297|3032326|Other|||||||0.696|||||||Chi-squared, Corrected||||
1648724|NCT01740297|3032327|Other||Hazard Ratio (HR)|0.83||||0.348|2-Sided|95.0|0.56|1.23|||Log Rank||Obtained from unstratified Cox Proportional Hazard Model||
1648725|NCT01740297|3032329|Other||Hazard Ratio (HR)|1.41||||0.228|2-Sided|95.0|0.8|2.49||P-value is descriptive|Log Rank||Obtained from unstratified Cox Proportional Hazard Model.||
1648726|NCT01740297|3032330|Other||Odds Ratio (OR)|2.8||||0.007|2-Sided|95.0|1.4|5.8||P-value is descriptive.|Chi-squared, Corrected||Obtained from the unstratified logistic regression model.||
1648727|NCT01740297|3032331|Other||Odds Ratio (OR)|1.9||||0.033|2-Sided|95.0|1.1|3.4||P-value is descriptive|Chi-squared, Corrected||Obtained from the unstratified logistic regression model.||
1648728|NCT01740297|3032334|Superiority||Odds Ratio (OR)|2.9||||0.002|2-Sided|95.0|1.5|5.5|||Chi-squared, Corrected||Obtained from the unstratified logistic regression model.||
1648729|NCT01739803|3032361|Superiority or Other||Risk Ratio (RR)|0.05||||0.05|2-Sided|95.0|||||Chi-squared||||
1648730|NCT01739803|3032362|Superiority or Other|||||||0.05|||||||ANOVA||||
1648731|NCT01739803|3032363|Superiority or Other||||||<|0.05||||||To control for experiment-wise Type I error rate in this analysis, a comparison-wise alpha of 0.01 was used.|Mixed Models Analysis|||We projected mean composite adherence rate for all participants to be approximately 80% ± 15. We anticipated at least 10% increase in intervention group adherence at end of intervention. To have 80% power to detect expected difference of 10% at the 2-tailed 5% significance level, sample size needed to be at least 36 RTRs per group. We took a conservative approach, in combination with anticipated attrition over the course of study, and increased enrollment.|
1648732|NCT01739790|3032364|Other|||||||0.45|||||||Fisher Exact||||
1648733|NCT01739361|3032373|Superiority or Other|||||||0.353|||||||Wilcoxon (Mann-Whitney)||||
1648734|NCT01739348|3032374|Superiority||Difference in Least Squares Means|0.5||||0.0599|2-Sided|95.0|0.0|1.0|||Longitudinal ANCOVA||||
1648735|NCT01739348|3032374|Superiority||Difference in Least Squares Means|0.2||||0.4721|2-Sided|95.0|-0.3|0.7|||Longitudinal ANCOVA||||
1648736|NCT01739348|3032375|Superiority||Difference in Least Squares Means|1.1||||0.1372|2-Sided|95.0|-0.4|2.6|||Longitudinal ANCOVA||||
1648737|NCT01739348|3032375|Superiority||Difference in Least Squares Means|0.7||||0.2949|2-Sided|95.0|-0.6|2.1|||Longitudinal ANCOVA||||
1648738|NCT01739348|3032377|Superiority||Difference in Least Squares Means|-0.04|||<|0.0001|2-Sided|95.0|-0.06|-0.02|||Longitudinal ANCOVA||||
1648739|NCT01739348|3032377|Superiority||Difference in Least Squares Means|-0.03|||<|0.0066|2-Sided|95.0|-0.05|0.0|||Longitudinal ANCOVA||||
1648740|NCT01739348|3032378|Superiority||Ratio of Fold Change from Baseline|0.97||||0.433|2-Sided|95.0|0.9|1.05|||Longitudinal ANCOVA||||
1648741|NCT01739348|3032378|Superiority||Ratio of Fold Change from Baseline|0.95||||0.2138|2-Sided|95.0|0.87|1.04|||Longitudinal ANCOVA||||
1648742|NCT01739348|3032379|Superiority||Difference in Least Squares Means|-0.7||||0.0002|2-Sided|97.51|-1.1|-0.3|||Longitudinal ANCOVA||||
1648743|NCT01739348|3032379|Superiority||Difference in Least Squares Means|-0.6||||0.0005|2-Sided|97.51|-1.0|-0.2|||Longitudinal ANCOVA||||
1648744|NCT01739348|3032380|Superiority||Difference in Least Squares Means|0.0||||0.8264|2-Sided|97.51|-0.3|0.4|||Longitudinal ANCOVA||||
1648745|NCT01739348|3032380|Superiority||Difference in Least Squares Means|0.0||||0.8426|2-Sided|97.51|-0.4|0.3|||Longitudinal ANCOVA||||
1648746|NCT01739348|3032387|Superiority||Difference in Least Squares Means|0.7||||0.3221|2-Sided|97.51|-0.9|2.3|||Longitudinal ANCOVA||||
1648747|NCT01739348|3032387|Superiority||Difference in Least Squares Means|0.5||||0.4925|2-Sided|97.51|-1.1|2.1|||Longitudinal ANCOVA||||
1648748|NCT01739348|3032388|Superiority||Difference in Least Squares Mean|0.4||||0.4625|2-Sided|97.51|-0.8|1.5|||Longitudinal ANCOVA||||
1648749|NCT01739348|3032388|Superiority||Difference in Least Squares Mean|0.2||||0.6287|2-Sided|97.51|-0.9|1.3|||Longitudinal ANCOVA||||
1648750|NCT01738971|3032478|Superiority or Other||relative probability|2.57||||0.006||95.0|1.55|4.27||see above comments regarding analysis taking cluster randomised account into consideration|t-test, 2 sided|||"Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in rapid access group compared to control."|
1648751|NCT01738971|3032478|Superiority or Other||relative probability|3.13|||<|0.001||95.0|1.9|5.13|||t-test, 2 sided|see above description of analysis taking into account cluster randomisation||"Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in progestogen only pill group compared to control."|
1648755|NCT01738477|3032572|Non-Inferiority|To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-tetanus. Objective of non-inferiority was considered to be met if the LL of the 95% CI was above -10%.|Mean Difference (Final Values)|0.0||||||95.0|-3.25|9.95||||||Non-inferiority in terms of seroprotection rates to tetanus.|
1648756|NCT01738477|3032572|Non-Inferiority|To assess the non-inferiority of the second dose of Boostrix (Boostrix 2 Group) minus first dose of Boostrix (Boostrix 1 Group) for anti-diphtheria. Objective of non-inferiority was considered to be met if the lower limit (LL) of the 95% confidence interval (CI) was greater than, or equal to -10%.|Mean Difference (Final Values)|0.0||||||95.0|-3.25|9.95||||||Non-inferiority in terms of seroprotection rates to diphtheria.|
1648757|NCT01738191|3032584|Superiority|||||||0.25||||||two sided|Global Statistical Test|df=28||The primary comparison between ATM and placebo used O’Brien’s Global Statistical Test (GST) to analyze change from baseline to 10 weeks for the set of neuropsychological measures included in the primary efficacy outcome.|
1648758|NCT01737944|3032608|Non-Inferiority or Equivalence|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of Cmax/Dose were within the range of 80% to 125%.|Test / Reference Ratio|89.79|||||2-Sided|90.0|81.61|98.78|||||||
1648759|NCT01737944|3032608|Non-Inferiority or Equivalence|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment B-SC injection without the device was established if the 90% CI for the geometric LS Mean ratios of Cmax/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.76|||||2-Sided|90.0|87.93|106.47|||||||
1648760|NCT01737944|3032609|Non-Inferiority or Equivalence|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-24)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|101.14|||||2-Sided|90.0|97.06|105.4|||||||
1648761|NCT01737944|3032609|Non-Inferiority or Equivalence|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment B-SC injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-24)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.22|||||2-Sided|90.0|92.32|100.28|||||||
1648762|NCT01737944|3032610|Non-Inferiority or Equivalence|The bioequivalence of Methotrexate following Treatment A-SC injection with the Vibex MTX device and Treatment C-IM injection was established if the 90% CI for the geometric LS Mean ratios of AUC(0-inf)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|101.28|||||2-Sided|90.0|97.17|105.56|||||||
1648763|NCT01737944|3032610|Non-Inferiority or Equivalence|The bioequivalence of Methotrexate following Treatment A - SC injection with the Vibex MTX device and Treatment B - SC injection without the device was established if the 90% CI for the geometric LS Mean ratios of AUC(0-inf)/Dose were within the range of 80% to 125%.|Test / Reference Ratio|96.24|||||2-Sided|90.0|92.33|100.31|||||||
1648764|NCT01737710|3032623|Superiority or Other||Odds Ratio (OR)|0.45||||0.143|2-Sided|95.0|0.13|1.39|||Fisher Exact|Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.|||
1648765|NCT01737710|3032624|Superiority or Other||Odds Ratio (OR)|0.77||||0.783|2-Sided|95.0|0.21|2.62||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.|Fisher Exact||||
1648766|NCT01737710|3032625|Superiority or Other||Odds Ratio (OR)|0.75||||0.378|2-Sided|95.0|0.4|1.38||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.|Fisher Exact||||
1648767|NCT01737710|3032626|Superiority or Other||Odds Ratio (OR)|1.17||||0.833|2-Sided|95.0|0.47|2.92||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H3N2 at Day 28 between the two groups.|Fisher Exact||||
1648768|NCT01737710|3032627|Superiority or Other||Odds Ratio (OR)|0.81||||0.791|2-Sided|95.0|0.24|2.65||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza H1N1 at Day 28 between the two groups.|Fisher Exact||||
1648769|NCT01737710|3032628|Superiority or Other||Odds Ratio (OR)|1.57||||0.14|2-Sided|95.0|0.84|2.94||Null hypothesis: no difference in the percentage of participants that were seroconverted against influenza B at Day 28 between the two groups.|Fisher Exact||||
1648770|NCT01737710|3032629|Superiority or Other||Odds Ratio (OR)|0.36||||0.218|2-Sided|95.0|0.06|1.58||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.|Fisher Exact||||
1648771|NCT01737710|3032630|Superiority or Other||Odds Ratio (OR)|0.43||||0.253|2-Sided|95.0|0.09|1.63||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups.|Fisher Exact||||
1648772|NCT01737710|3032631|Superiority or Other||Odds Ratio (OR)|1.03|||>|0.999|2-Sided|95.0|0.54|1.97||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza B at Day 28 between the two groups.|Fisher Exact||||
1648773|NCT01737710|3032632|Superiority or Other||Mean Difference (Final Values)|1.04||||0.895|2-Sided|95.0|0.6|1.8||Null hypothesis: the fold differences in geometric mean titers against influenza H3N2 are not different between the two groups.|ANCOVA||||
1648774|NCT01737710|3032633|Superiority or Other||Mean Difference (Final Values)|0.59||||0.103|2-Sided|95.0|0.32|1.11||Null hypothesis: the fold differences in geometric mean titers against influenza H1N1 are not different between the two groups.|ANCOVA||||
1648775|NCT01737710|3032634|Superiority or Other||Mean Difference (Final Values)|1.25||||0.092|2-Sided|95.0|0.96|1.61||Null hypothesis: the fold differences in geometric mean titers against influenza B are not different between the two groups.|ANCOVA||||
1648776|NCT01737710|3032635|Superiority or Other||Odds Ratio (OR)|2.02||||0.177|2-Sided|95.0|0.75|5.71||Null hypothesis: no difference in the percentage of participants that were seroprotected against influenza H3N2 at Day 28 between the two groups.|Fisher Exact||||
1648777|NCT01737710|3032636|Superiority or Other||Odds Ratio (OR)|0.83||||0.801|2-Sided|95.0|0.26|2.56||Null hypothesis: no difference in the percent of participants that were seroprotected against influenza H1N1 at Day 28 between the two groups|Fisher Exact||||
1648783|NCT01736475|3032893|Superiority or Other||Ratio of means|0.1|||<|0.0001|2-Sided|95.0|0.06|0.19|||Regression, Negative binomial|||Ratio Annualized Bleeding Rate (ABR) Prophylaxis/On-demand: Prophylaxis treatment w ill be considered to be successful if the upper limit of the 95% CI for the ratio between treatment regimen does not exceed 0.5 (corresponding to a 50% reduction of the mean ABR compared to the on-demand treatment). H01: μ1 ≥0.5*μ2 Ha1: μ1<0.5*μ2 w here μ1 and μ2 are the mean ABRs in on prophylaxis and on-demand, respectively|
1648784|NCT01736215|3032920|Superiority or Other||Odds Ratio (OR)|0.125||||0.05|2-Sided|95.0|0.016|0.999||The binary logistic regression analysis was performed using a crude model between predictor variable CRP (CRP less than or equal to 10.3 and CRP greater than 10.4)|Regression, Logistic||||
1648785|NCT01736215|3032921|Superiority or Other||Odds Ratio (OR)|0.343||||0.266|2-Sided|95.0|0.052|2.261||The binary logistic regression analysis was performed using a crude model between predictor variable endogenous EPO (EPO less than or equal to 45.2 and EPO greater than 45.3)|Regression, Logistic||||
1648786|NCT01736176|3032962|Superiority or Other|||||||0.004|||||||Mixed-effect Repeated Measures (MMRM)|MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.|||
1648787|NCT01736176|3032966|Superiority or Other||||||<|0.001|||||||Mixed-effect Repeated Measures (MMRM)|MMRM model included the fixed effects of study site and visit, with baseline score as a covariate, and the baseline-by-visit interaction.||The primary null hypothesis was no change in least-square (LS) mean, calculated using a mixed-effect repeated measures model (MMRM), for NMSS total score from baseline to Week 12. The statistical test was two-sided and the null hypothesis was rejected at the significance level of α = 0.050.|
1648788|NCT01735877|3032980|Superiority or Other|||||||0.01|||||||Chi-squared|||At month 6|
1648789|NCT01735877|3032980|Superiority or Other|||||||0.04|||||||Chi-squared|||At month 3|
1648790|NCT01735877|3032980|Superiority or Other|||||||0.99|||||||Chi-squared|||At month 1|
1648791|NCT01735877|3032980|Superiority or Other|||||||0.99|||||||Chi-squared|||At Baseline|
1648792|NCT01735877|3032981|Superiority or Other||Mean Difference (Final Values)|3.21|||<|0.0001|2-Sided|95.0|2.4|4.02|||ANCOVA|||Mean change from baseline to 6 month|
1648793|NCT01735877|3032981|Superiority or Other||Mean Difference (Final Values)|3.41|||<|0.0001|2-Sided|95.0|2.61|4.21|||ANCOVA|||Mean change from baseline to 3 month|
1648794|NCT01735877|3032981|Superiority or Other||Mean Difference (Final Values)|3.68|||<|0.0001|2-Sided|95.0|2.93|4.42|||ANCOVA|||Mean change from baseline to 1 month|
1648795|NCT01735877|3032981|Superiority or Other||Mean Difference (Final Values)|0.64|Standard Error of the Mean|0.24|<|0.99|||||||t-test, 2 sided|||Baseline|
1648796|NCT01735877|3032982|Superiority or Other||Mean Difference (Final Values)|8.63||||0.006|2-Sided|95.0|2.67|14.6|||ANCOVA|||Mean change from baseline to 6 month|
1648797|NCT01735877|3032982|Superiority or Other||Mean Difference (Final Values)|8.71||||0.005|2-Sided|95.0|2.8|14.63|||ANCOVA|||Mean change from baseline to 3 month|
1648798|NCT01735877|3032982|Superiority or Other||Mean Difference (Final Values)|5.92||||0.002|2-Sided|95.0|2.24|9.6|||ANCOVA|||Mean change from baseline to 1 month|
1648799|NCT01735877|3032982|Superiority or Other||Mean Difference (Final Values)|1.51|Standard Error of the Mean|3.25||0.64|||||||t-test, 2 sided|||At Baseline|
1648800|NCT01735877|3032983|Superiority or Other|||||||0.004|||||||Chi-squared|||At 6 months|
1648801|NCT01735877|3032983|Superiority or Other|||||||0.03|||||||Chi-squared|||At 3 months|
1648802|NCT01735877|3032983|Superiority or Other|||||||0.99|||||||Chi-squared|||At 1 month|
1648803|NCT01735877|3032983|Superiority or Other|||||||0.99|||||||Chi-squared|||At Baseline|
1648804|NCT01735877|3032984|Superiority or Other||Mean Difference (Final Values)|23.28|||<|0.0001|2-Sided|95.0|18.94|27.62|||ANCOVA|||Baseline to 6 month|
1648805|NCT01735877|3032984|Superiority or Other||Mean Difference (Final Values)|22.56|||<|0.0001|2-Sided|95.0|18.65|26.48|||ANCOVA|||Baseline to 3 month|
1648806|NCT01735877|3032984|Superiority or Other||Mean Difference (Final Values)|14.12|||<|0.0001|2-Sided|95.0|11.02|17.25|||ANCOVA|||Mean Change from baseline to 1 month|
1648807|NCT01735877|3032984|Superiority or Other||Mean Difference (Final Values)|-0.43|Standard Error of the Mean|1.52|<|0.77|||||||t-test, 2 sided|||At Baseline|
1648808|NCT01735617|3032999|Superiority or Other||Geometric means|563.38|Standard Deviation|162.51|||2-Sided|||||||||The pharmacokinetic profile was characterised by an overnight rise in cortisol levels reaching a maximal concentration approximately 8 hours post dosing.|
1648809|NCT01735175|3033025|Non-Inferiority|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|0.07||||0.05|2-Sided|95.0|-0.12|0.26|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).|LA-EP2006 is non-inferior to Neulasta® because the lower bound of the 95% CI is entirely above the non-inferiority margin of -0.6 days.|"The hierarchical test procedure aimed to show that~LA-EP2006 and Neulasta® are equivalent with respect to DSN duration in Cycle 1 (margin±1 day), and, if so~LA-EP2006 is non-inferior to Neulasta® with respect to DSN duration in Cycle 1 (margin of -0.6 days)."|
1648810|NCT01735175|3033025|Equivalence|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|0.07||||0.05|2-Sided|95.0|-0.12|0.26|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).|The difference between LA-EP2006 and reference pegfilgrastim was 0.07 days (95% CI [-0.12, 0.26]). 95% CIs were within the predefined margin of ±1 day confirming equivalence.|"The hierarchical test procedure aimed to show that~LA-EP2006 and Neulasta® are equivalent with respect to DSN duration in Cycle 1 (margin±1 day), and, if so~LA-EP2006 is non-inferior to Neulasta® with respect to DSN duration in Cycle 1 (margin of -0.6 days)."|
1648824|NCT01734772|3033061|Non-Inferiority or Equivalence|Relative bioavailability|geometric Mean Ratio|126.47|Standard Deviation|33.3||0.5481||90.0|107.363|148.967||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.||
1648811|NCT01734902|3033049|Equivalence|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subject within sequences’ was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R [%]|90.03|Standard Error of the Mean|29.3|||2-Sided|90.0|78.78|102.88|||||Standard error of the mean is actually intra-individual geometric coefficient variance [%]. Statistical analysis is based on PKS which includes 27 subjects.||
1648812|NCT01734902|3033050|Equivalence|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subject within sequences’ was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R (%)|89.05|Standard Error of the Mean|31.2|||2-Sided|90.0|77.26|102.62|||||Standard error of the mean is actually intra-individual geometric coefficient variance [%]. Statistical analysis is based on PKS which includes 27 subjects.||
1648813|NCT01734902|3033051|Equivalence|The statistical model, analysis of variance (ANOVA) on the logarithmic scale includes effects: ‘sequence’, ‘subjects within sequences’, ‘period’, and ‘treatment’. The effect ‘subject within sequences’ was considered as random, whereas the other effects were considered as fixed.|Adjusted gMean ratio T/R (%)|86.97|Standard Error of the Mean|35.6|||2-Sided|90.0|74.046|102.151|||||Standard error of the mean is actually intra-individual geometric coefficient variance [%]. Statistical analysis is based on PKS which includes 27 subjects.||
1648814|NCT01734785|3033057|Superiority or Other||Mean Difference (Final Values)|-2.77|Standard Error of the Mean|0.36|<|0.0001||95.0|-3.47|-2.07|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo:change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) & baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).|
1648815|NCT01734785|3033057|Superiority or Other||Mean Difference (Final Values)|-2.22|Standard Error of the Mean|0.36|<|0.0001||95.0|-2.92|-1.52|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in body weight using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline weight, baseline HbA1c as linear covariate(s) & baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).|
1648816|NCT01734785|3033058|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|0.26|<|0.0001||95.0|-2.31|-1.28|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) & baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).|
1648817|NCT01734785|3033058|Superiority or Other||Mean Difference (Final Values)|-2.09|Standard Error of the Mean|0.26|<|0.0001||95.0|-2.61|-1.57|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in FPG using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline FPG, baseline HbA1c as linear covariate(s) & baseline eGFR, geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).|
1648818|NCT01734785|3033059|Superiority or Other||Mean Difference (Final Values)|-0.79|Standard Error of the Mean|0.12|<|0.0001||95.0|-1.02|-0.55|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 10 mg minus Placebo.|Superiority of Empagliflozin 10 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) & baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).|
1648819|NCT01734785|3033059|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.12|<|0.0001||95.0|-0.93|-0.46|||Mixed Models Analysis|The unstructured covariance structure has been used to fit the mixed model.|Mean Difference (Final Values) is actually the Adjusted mean difference calculated as Empagliflozin 25 mg minus Placebo.|Superiority of Empagliflozin 25 mg vs. placebo: change in HbA1c using a restricted maximum likelihood (REML)- based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c as linear covariate(s) & baseline Estimated glomerula filtration rate (eGFR), geographical region, treatment, visit, visit by treatment interaction as fixed effect(s).|
1648820|NCT01734772|3033060|Non-Inferiority or Equivalence|Relative bioavailability|gMean Ratio|123.82|Standard Deviation|36.9||0.4656||90.0|102.695|149.288||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.||
1648821|NCT01734772|3033060|Non-Inferiority or Equivalence|Relative bioavailability|geometric Mean Ratio|128.61|Standard Deviation|39.0||0.6003||90.0|106.37|155.495||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.||
1648822|NCT01734772|3033060|Non-Inferiority or Equivalence|Relative bioavailability|geometric Mean Ratio|164.74|Standard Deviation|42.9||0.9841||90.0|133.945|202.619||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.||
1648823|NCT01734772|3033061|Non-Inferiority or Equivalence|Relative bioavailability|geometric Mean Ratio|127.01|Standard Deviation|31.6||0.5665||90.0|108.047|149.295||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.||
1648880|NCT01732718|3033283|Superiority|||||||0.1469|||||||t-test, 1 sided|||Comparison of the change in AMC|
1648881|NCT01732718|3033284|Superiority|||||||0.64|||||||Wilcoxon (Mann-Whitney)||||
1648825|NCT01734772|3033061|Non-Inferiority or Equivalence|Relative bioavailability|geometric Mean Ratio|149.38|Standard Deviation|37.6||0.9456||90.0|124.388|179.383||p-value for ratio outside interval 80% - 125%|ANOVA|Adjustment for effects 'subject' and 'treatment'.|The dispersion value is actually the intraindividual gCV.||
1648826|NCT01734655|3033066|Superiority or Other||||||<|0.01|||||||correlation analysis||||
1648827|NCT01734655|3033067|Superiority or Other||||||<|0.01|||||||correlation analysis||||
1648828|NCT01734655|3033068|Superiority or Other||||||<|0.01|||||||correlation analysis||||
1648829|NCT01734395|3033080|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Deviation|2.43|<|0.0001|2-Sided|95.0|-0.814|-0.5586|||t-test, 2 sided||||
1648830|NCT01734395|3033081|Superiority or Other||Mean Difference (Final Values)|1.48|Standard Deviation|10.69|<|0.0001|2-Sided|95.0|0.9188|2.0438|||t-test, 2 sided||||
1648831|NCT01734395|3033082|Superiority or Other||Mean Difference (Final Values)|-1.19|Standard Deviation|4.56|<|0.0001|2-Sided|95.0|-1.4262|-0.9467|||t-test, 2 sided||||
1648832|NCT01733758|3033121|Superiority or Other||||||<|0.0001||||||The second test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.|t-test, 2 sided|The p-value is from a 2-sided t-test to test whether the difference of LS means (albiglutide 30 mg – placebo) is equal to zero.|||
1648833|NCT01733758|3033121|Superiority or Other||||||<|0.0001||||||The first test in a sequential testing procedure starting with albiglutide 50 mg versus placebo, and if significant at 0.05 level, followed by albiglutide 30 mg versus placebo.|t-test, 2 sided|The p-value is from a 2-sided t-test to test whether the difference of least squares (LS) means (albiglutide 50 mg – placebo) is equal to zero.|||
1648834|NCT01733758|3033121|Superiority or Other||Mean Difference (Net)|-1.35|||<||2-Sided|95.0|-1.51|-1.18|||||||
1648835|NCT01733758|3033121|Superiority or Other||Mean Difference (Net)|-1.55|||<||2-Sided|95.0|-1.72|-1.39|||||||
1648836|NCT01733628|3033143|Other|Type of statistical Test: Inequality|Hazard Ratio (HR)|0.94||||0.8166|2-Sided|95.0|0.56|1.59|||Wilcoxon (Mann-Whitney)||||
1648837|NCT01733329|3033157|Superiority or Other|||||||0.007|||||||Kruskal-Wallis||||
1648838|NCT01733329|3033158|Superiority or Other|||||||0.058|||||||Fisher Exact||||
1648839|NCT01733329|3033159|Superiority or Other|||||||0.026|||||||Fisher Exact||||
1648840|NCT01733329|3033160|Superiority or Other||||||<|0.01|||||||Fisher Exact||||
1648841|NCT01733316|3033166|Superiority|||||||0.0048||||||Paired t-test testing the null hypothesis that the population average difference during the Cystagon® phase is equal to the population average difference during the RP103 phase.|Paired t-test, two-sided||||
1648842|NCT01733212|3033172|Equivalence|Considering the null hypothesis that the number of participants who will have vomiting will be equal in the two arms, we performed this study with a significance level of 0.05% and power of 80% to prove that there is a difference in the number.||||||0.07|||||||Chi-squared|||Number of participants who had vomiting in each group is compared to the other. Two sided Chi square test was conducted, Type I error of 0.05% and power of 80% are considered.|
1648843|NCT01733121|3033173|Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|-1.2|-0.5|||ANOVA||||
1648844|NCT01733121|3033174|Other||Mean Difference (Final Values)|-2.4|Standard Error of the Mean|0.7||0.0005|2-Sided|95.0|-3.7|-1.1|||ANCOVA||||
1648845|NCT01733121|3033175|Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|-1.2|-0.4|||ANOVA||||
1648846|NCT01733121|3033176|Other||Mean Difference (Final Values)|-3.0|Standard Error of the Mean|0.7|<|0.0001|2-Sided|95.0|-4.5|-1.6|||ANCOVA||||
1648847|NCT01732822|3033218|Superiority or Other||Hazard Ratio (HR)|1.58|||<|0.001|2-Sided|95.0|1.24|2.0|||Regression, Cox||||
1648848|NCT01732822|3033219|Superiority or Other||Hazard Ratio (HR)|1.16||||0.139|2-Sided|95.0|0.95|1.41|||Regression, Cox||||
1648849|NCT01732822|3033220|Superiority or Other||Hazard Ratio (HR)|1.17||||0.138|2-Sided|95.0|0.95|1.43|||Regression, Cox||||
1648850|NCT01732822|3033221|Superiority or Other||Hazard Ratio (HR)|1.1||||0.489|2-Sided|95.0|0.84|1.43|||Regression, Cox||||
1648851|NCT01732822|3033222|Superiority or Other||Hazard Ratio (HR)|1.01||||0.887|2-Sided|95.0|0.93|1.09|||Regression, Cox||||
1648852|NCT01732822|3033223|Superiority or Other||Hazard Ratio (HR)|0.87||||0.306|2-Sided|95.0|0.67|1.14|||Regression, Cox||||
1648853|NCT01732822|3033224|Superiority or Other||Hazard Ratio (HR)|0.87||||0.164|2-Sided|95.0|0.71|1.06|||Regression, Cox||||
1648854|NCT01732822|3033228|Superiority or Other||Hazard Ratio (HR)|0.93||||0.377|2-Sided|95.0|0.78|1.1|||Regression, Cox||||
1648855|NCT01732822|3033229|Superiority or Other||Hazard Ratio (HR)|1.0||||0.949|2-Sided|95.0|0.92|1.08|||Regression, Cox||||
1648856|NCT01732822|3033230|Superiority or Other||Hazard Ratio (HR)|0.99||||0.829|2-Sided|95.0|0.91|1.08|||Regression, Cox||||
1648857|NCT01732822|3033231|Superiority or Other||Hazard Ratio (HR)|1.0||||1|2-Sided|95.0|0.92|1.09|||Regression, Cox||||
1648858|NCT01732822|3033232|Superiority or Other||Hazard Ratio (HR)|1.01||||0.793|2-Sided|95.0|0.92|1.12|||Regression, Cox||||
1648859|NCT01732822|3033233|Superiority or Other||Hazard Ratio (HR)|0.97||||0.462|2-Sided|95.0|0.9|1.05||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox||||
1648860|NCT01732822|3033234|Superiority or Other||Hazard Ratio (HR)|0.95||||0.298|2-Sided|95.0|0.87|1.05||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox||||
1648861|NCT01732822|3033235|Superiority or Other||Hazard Ratio (HR)|1.03||||0.846|2-Sided|95.0|0.79|1.33||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox||||
1649239|NCT01728454|3033795|Superiority|||||||0.8919|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle|
1648862|NCT01732822|3033236|Superiority or Other||Hazard Ratio (HR)|1.02||||0.724|2-Sided|95.0|0.92|1.13||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox||||
1648863|NCT01732822|3033237|Superiority or Other||Hazard Ratio (HR)|0.99||||0.913|2-Sided|95.0|0.89|1.11||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox||||
1648864|NCT01732822|3033238|Superiority or Other||Hazard Ratio (HR)|1.06||||0.482|2-Sided|95.0|0.91|1.23||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox||||
1648865|NCT01732822|3033239|Superiority or Other||Hazard Ratio (HR)|1.07||||0.4|2-Sided|95.0|0.92|1.23||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox||||
1648866|NCT01732822|3033240|Superiority or Other||Hazard Ratio (HR)|1.02||||0.738|2-Sided|95.0|0.92|1.12||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox||||
1648867|NCT01732822|3033241|Superiority or Other||Hazard Ratio (HR)|1.02||||0.65|2-Sided|95.0|0.92|1.13||The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing|Regression, Cox||||
1648868|NCT01732796|3033242|Superiority or Other||Koch's method with continuity correction|9.9||||0.0089|2-Sided|95.0|1.7|18.1|||z-test|based on two sample z-test with continuity correction for variance.||Category: Percentage of patient with response|
1648869|NCT01732796|3033243|Superiority or Other||Koch's method with continuity correction|6.0||||0.0575|2-Sided|95.0|-1.5|13.5|||z-test|based on two sample z-test with continuity correction for variance.||Category: Percentage of patient with response|
1648870|NCT01732796|3033244|Superiority or Other||Koch's method with continuity correction|10.8||||0.004|2-Sided|95.0|2.8|18.8|||z-test|based on two sample z-test with continuity correction for variance.|||
1648871|NCT01732796|3033245|Superiority or Other||Adjusted response rate|71.7||||0.3989|2-Sided|95.0|66.1|77.4|||Stratified one sample z-test||Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN|The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).|
1648872|NCT01732796|3033245|Superiority or Other||Adjusted response rate|81.4|||<|0.0001|2-Sided|95.0|76.6|86.2|||Stratified one sample z-test||Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN|The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).|
1648873|NCT01732770|3033265|Superiority or Other (legacy)||Treatment Difference|1.4|||<|0.0001|2-Sided|95.0|1.0|1.7|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab – zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the superiority analysis the 2-sided significance level was 5%.|
1648874|NCT01732770|3033266|Superiority or Other (legacy)||Treatment Difference|2.1|||<|0.0001|2-Sided|95.0|1.6|2.6|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab – zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the superiority analysis the 2-sided significance level was 5%.|
1648875|NCT01732770|3033267|Non-Inferiority or Equivalence (legacy)|The lower bound of the 2-sided 95% CI) of (denosumab – zoledronic acid) was compared with the non-inferiority margin of -0.51% for assessing non-inferiority.|Treatment Difference|1.4|||<|0.0001|2-Sided|95.0|1.0|1.7|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab – zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the non-inferiority analysis the 1-sided significance level was 2.5%.|
1648876|NCT01732770|3033268|Non-Inferiority or Equivalence (legacy)|The lower bound of the 2-sided 95% confidence interval (CI) of (denosumab – zoledronic acid) was compared with the non-inferiority margin of -0.46% for assessing non-inferiority.|Treatment Difference|2.1|||<|0.0001|2-Sided|95.0|1.6|2.6|||ANCOVA|The model included treatment, screening sCTX, baseline BMD, DXA machine type (Hologic or Lunar), and baseline BMD-by-machine type interaction.|Treatment difference = denosumab – zoledronic acid|A step-down sequential testing procedure was used in order to maintain the overall type I error rate at 5% for the tests of primary and secondary BMD endpoints. For the non-inferiority analysis the 1-sided significance level was 2.5%.|
1648877|NCT01732718|3033280|Superiority|||||||0.5184|||||||Wilcoxon (Mann-Whitney)||||
1648878|NCT01732718|3033283|Superiority|||||||0.5833|||||||t-test, 1 sided|||Comparison of the change in ANC|
1648879|NCT01732718|3033283|Superiority|||||||0.2382|||||||t-test, 1 sided|||Comparison of the change in ALC|
1648882|NCT01732718|3033288|Superiority|||||||0.57|||||||see comments for explanation|albuminuria examined as continuous variable (linear mixed model to analyze effect) and categorical generalized variable (estimating equation approach)|||
1648883|NCT01732718|3033290|Superiority|||||||0.31|||||||Wilcoxon (Mann-Whitney)||||
1648884|NCT01732718|3033292|Superiority|||||||0.74|||||||Wilcoxon (Mann-Whitney)||||
1648885|NCT01732718|3033293|Superiority|||||||0.51|||||||Student t-test followed by ANOVA|Student t-test subsequently followed by crossover ANOVA model testing carry-over effect and treatment effect|||
1648886|NCT01732692|3033298|Non-Inferiority or Equivalence|The primary endpoint was analyzed by a non-inferiority test using the exact Farrington-Manning method. Non-inferiority of the two treatments was to be concluded if the lower end of the confidence interval of the difference the experimental treatment group (morning-only dose) – control treatment group (split dose) was above a non-inferiority margin of -0.15%.|Treatment Difference|0.0286|||<|0.001|1-Sided|95.0|-0.097||||Exact Farrington - Manning||Treatment Difference is the difference in proportion of participants with successful colon cleansing between treatments -experimental vs. control||
1648887|NCT01732549|3033314|Superiority or Other (legacy)||||||=|0|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use (or not) & region (Eastern Europe, Western Europe). One-sided p-value||Stratified[a]|
1648888|NCT01732549|3033315|Superiority or Other (legacy)||||||=|0|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified[a]|
1648889|NCT01732549|3033316|Superiority or Other (legacy)||||||=|0|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified[a]|
1648890|NCT01732549|3033317|Superiority or Other (legacy)|||||||0.5219|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified[a]|
1648891|NCT01732549|3033318|Superiority or Other (legacy)||||||=|0|||||||Log Rank|Adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). One-sided p-value||Stratified[a]|
1648892|NCT01732549|3033319|Superiority or Other (legacy)||||||=|0|||||||Log Rank|||Unstratified[b]|
1648893|NCT01732549|3033319|Superiority or Other (legacy)||||||=|0||||||Log-rank test adjusting for presence (or absence) of visceral metastases, opioid analgesic use and region (Eastern Europe, Western Europe). Two-sided p-value.|Log Rank|||Stratified[a]|
1648894|NCT01732536|3033321|Superiority|||||||0.0209||||||P-value not adjusted for multiplicity.|ANCOVA|Based on between arm comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects|||
1648895|NCT01732536|3033322|Superiority|||||||0.0175||||||P-value for change from baseline to 6 months not adjusted for multiplicity|ANCOVA|ANCOVA model with baseline as a covariate and site and treatment as fixed effects|||
1648896|NCT01732536|3033322|Superiority|||||||0.0162||||||P-value for change from baseline to 90 days not adjusted for multiplicity|ANCOVA|ANCOVA model with baseline as a covariate and site and treatment as fixed effects|||
1648897|NCT01732536|3033323|Superiority|||||||0.0099|||||||ANCOVA||||
1648898|NCT01732536|3033324|Superiority|||||||0.049|||||||ANOVA|Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect||Bilateral polyp grade change in a subset of 67 patients with higher polyp burden at baseline (grade 2 or higher on each side confirmed by the independent panel)|
1648899|NCT01732536|3033324|Superiority|||||||0.0985|||||||ANCOVA|Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect|||
1648900|NCT01732536|3033325|Superiority|||||||0.0505||||||Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects|ANCOVA|||The change from baseline to Day 90 in Nasal Obstruction/Congestion score in the subset of participants with higher polyp burden at baseline (grade 2 or higher polyps on each side; N=67).|
1648901|NCT01732536|3033325|Superiority|||||||0.1365|||||||ANCOVA|Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects|||
1648902|NCT01732510|3033343|Superiority or Other||Mean Difference (Final Values)|-9.82||||0.015|2-Sided|95.0|-16.87|-2.77|||Constrained longitudinal data analysis|||The reduction from baseline in EASI at week 12 for participants receiving MK-8226 3 mg/kg was compared to placebo (MK-8226 3 mg - Placebo). The constrained longitudinal data analysis model used variance component covariance matrix to model correlation among repeated visits, without adjustment for interaction of treatment group by visit.|
1648903|NCT01732458|3033353|Superiority or Other||Difference in Percentage vs. Ondansetron|-12.4|||||2-Sided|95.0|-30.3|6.3||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.|
1648904|NCT01732458|3033353|Superiority or Other||Difference in Percentage vs. Ondansetron|-4.4|||||2-Sided|95.0|-22.9|14.3||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.|
1648905|NCT01732458|3033353|Superiority or Other||Difference in Percentage vs. Ondansetron|-16.5|||||2-Sided|95.0|-34.0|2.0||||||The Miettinen and Nurminen method was used to provide 95% confidence intervals (CIs) for between-treatment differences in the percentage of participants with events.|
1648906|NCT01731990|3033435|Superiority or Other||Treatment effect for ratio to placebo|1.06||||0.284|2-Sided|90.0|0.97|1.15|||Mixed Models Analysis||||
1648907|NCT01731600|3033466|Other||Incidence rate|0.0|||||1-Sided|97.5||0.067|||||The incidence of inhibitory antibodies was calculated as number of patients with inhibitors during the main phase of the trial divided by number of patients in the main phase of the trial.|A one-sided, upper 97.5% confidence limit was provided based on an exact calculation in the binomial distribution.|
1648908|NCT01731171|3033469|Superiority||||||=|0|||||||Kruskal-Wallis||||
1648909|NCT01731171|3033470|Superiority||||||=|0|||||||Regression, Linear||||
1648910|NCT01731171|3033471|Superiority||||||=|0|||||||Chi-squared||||
1648940|NCT01730339|3033535|Superiority or Other||Least Square mean difference|0.16|Standard Error of the Mean|2.72|||2-Sided|90.0|-4.37|4.68||||||Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648911|NCT01731171|3033472|Other|The effect of treatment was calculated using logistic regression and the Cox proportional hazard function employing age, gender, and race as covariates.|Cox Proportional Hazard|0.37|||=|0|2-Sided|95.0|||||Regression, Logistic||Values less than one favor adjunctive probiotic treatment, while values higher than one favor the placebo.||
1648912|NCT01730950|3033484|Superiority||Hazard Ratio (HR)|0.73||||0.05|2-Sided|95.0|0.53|1.0|||Log Rank|Two-sided significance level = 0.05|Reference level = Bevacizumab||
1648913|NCT01730950|3033485|Superiority|||||||0.001|||||||Chi-squared|Two-sided significance level = 0.05|||
1648914|NCT01730950|3033486|Superiority|||||||0.18|||||||Chi-squared|Two-sided significance level = 0.05|||
1648915|NCT01730950|3033487|Superiority||Hazard Ratio (HR)|0.98||||0.46|2-Sided|95.0|0.7|1.38|||Log Rank|Two-side significance level = 0.05|Reference level = Bevacizumab|Null hypothesis: median survival time for both arms is 9 months; alternative hypothesis: participants receiving radiation therapy plus bevacizumab will have an improvement in median survival time to 13 months. One hundred and sixty eligible participants provides 80% power to detect a 31% reduction in the hazard ratio to 0.69 at a one-sided significance level of 0.10. Analysis was planned to occur when 135 deaths were reported, expected to occur 16 to 21 months after trial closure.|
1648916|NCT01730534|3033506|Superiority||Hazard Ratio (HR)|0.93||||0.198||95.0|0.82|1.04|||Regression, Cox||||
1648917|NCT01730534|3033507|Superiority||Hazard Ratio (HR)|0.76|||<|0.001||95.0|0.67|0.87|||Regression, Cox||||
1648918|NCT01730534|3033508|Superiority||Hazard Ratio (HR)|0.83||||0.005||95.0|0.73|0.95|||Regression, Cox||||
1648919|NCT01730534|3033509|Superiority||Hazard Ratio (HR)|0.93||||0.172||95.0|0.84|1.03|||Regression, Cox||||
1648920|NCT01730339|3033534|Superiority or Other||Least Square mean difference|0.15|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.11|0.4||||||Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648921|NCT01730339|3033534|Superiority or Other||Least Square mean difference|0.2|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.09|0.5||||||Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648922|NCT01730339|3033534|Superiority or Other||Least Square mean difference|-0.01|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.27|0.24||||||Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648923|NCT01730339|3033534|Superiority or Other||Least Square mean difference|0.42|Standard Error of the Mean|0.18|||2-Sided|90.0|0.12|0.72||||||Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648924|NCT01730339|3033534|Superiority or Other||Least Square mean difference|0.07|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.18|0.33||||||Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648925|NCT01730339|3033534|Superiority or Other||Least Square mean difference|0.0|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.29|0.3||||||Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648926|NCT01730339|3033534|Superiority or Other||Least Square mean difference|-0.02|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.28|0.23||||||Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648927|NCT01730339|3033534|Superiority or Other||Least Square mean difference|0.1|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.2|0.39||||||Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648928|NCT01730339|3033534|Superiority or Other||Least Square mean difference|0.07|Standard Deviation|0.15|||2-Sided|90.0|-0.18|0.32||||||Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648929|NCT01730339|3033534|Superiority or Other||Least Square mean difference|0.43|Standard Error of the Mean|0.15|||2-Sided|90.0|0.18|0.68||||||Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648930|NCT01730339|3033534|Superiority or Other||Least Square mean difference|0.05|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.21|0.3||||||Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648931|NCT01730339|3033534|Superiority or Other||Least Square mean difference|0.57|Standard Error of the Mean|0.15|||2-Sided|90.0|0.32|0.82||||||Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648932|NCT01730339|3033534|Superiority or Other||Least Square mean difference|-0.1|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.36|0.15||||||Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648933|NCT01730339|3033534|Superiority or Other||Least Square mean difference|0.29|Standard Error of the Mean|0.15|||2-Sided|90.0|0.04|0.54||||||Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648934|NCT01730339|3033534|Superiority or Other||Least Square mean difference|0.03|Standard Error of the Mean|0.16|||2-Sided|90.0|-0.22|0.29||||||Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648935|NCT01730339|3033534|Superiority or Other||Least Square mean difference|0.1|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.15|0.35||||||Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648936|NCT01730339|3033535|Superiority or Other||Least Square mean difference|-1.13|Standard Error of the Mean|1.87|||2-Sided|90.0|-4.24|1.99||||||Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648937|NCT01730339|3033535|Superiority or Other||Least Square mean difference|1.75|Standard Error of the Mean|2.3|||2-Sided|90.0|-2.07|5.58||||||Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648938|NCT01730339|3033535|Superiority or Other||Least Square mean difference|-1.54|Standard Error of the Mean|1.8|||2-Sided|90.0|-4.53|1.45||||||Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648939|NCT01730339|3033535|Superiority or Other||Least Square mean difference|-0.7|Standard Error of the Mean|2.19|||2-Sided|90.0|-4.34|2.95||||||Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648941|NCT01730339|3033535|Superiority or Other||Least Square mean difference|3.82|Standard Error of the Mean|3.85|||2-Sided|90.0|-2.6|10.24||||||Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648942|NCT01730339|3033535|Superiority or Other||LS mean difference|-0.36|Standard Error of the Mean|1.97|||2-Sided|90.0|-3.63|2.91||||||Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648943|NCT01730339|3033535|Superiority or Other||Least Square mean difference|1.32|Standard Error of the Mean|2.76|||2-Sided|90.0|-3.28|5.92||||||Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648944|NCT01730339|3033536|Superiority or Other||Least Square mean difference|-0.18|Standard Error of the Mean|0.3||0.5413|2-Sided|90.0|-0.67|0.31|||Repeated measures model|||Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648945|NCT01730339|3033536|Superiority or Other||Least Square mean difference|0.28|Standard Error of the Mean|0.39||0.473|2-Sided|90.0|-0.37|0.93|||Repeated measures model|||Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648946|NCT01730339|3033536|Superiority or Other||Least Square mean difference|0.0|Standard Error of the Mean|0.29||0.998|2-Sided|90.0|-0.47|0.47|||Repeated measures model|||Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648947|NCT01730339|3033536|Superiority or Other||Least Square mean difference|0.44|Standard Error of the Mean|0.38||0.2491|2-Sided|90.0|-0.19|1.07|||Repeated measures model|||Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648948|NCT01730339|3033536|Superiority or Other||Least Square mean difference|0.21|Standard Error of the Mean|0.25||0.401|2-Sided|90.0|-0.21|0.63|||Repeated measures model|||Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648949|NCT01730339|3033536|Superiority or Other||Least Square mean difference|0.01|Standard Error of the Mean|0.33||0.9842|2-Sided|90.0|-0.55|0.56|||Repeated measures model|||Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648950|NCT01730339|3033536|Superiority or Other||LS mean difference|0.11|Standard Error of the Mean|0.25||0.6605|2-Sided|90.0|-0.3|0.52|||Repeated measures model|||Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648951|NCT01730339|3033536|Superiority or Other||Least Square mean difference|0.1|Standard Error of the Mean|0.32||0.7552|2-Sided|90.0|-0.44|0.64|||Repeated measures model|||Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648952|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.11|Standard Error of the Mean|0.28||0.6848|2-Sided|90.0|-0.35|0.58|||Repeated measures model|||Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.|
1648953|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.82|Standard Error of the Mean|0.28||0.0044|2-Sided|90.0|0.35|1.29|||Repeated measures model|||Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.|
1648954|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.22|Standard Error of the Mean|0.25||0.3788|2-Sided|90.0|-0.64|0.19|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.|
1648955|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.23|Standard Error of the Mean|0.25||0.3515|2-Sided|90.0|-0.18|0.65|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.|
1648956|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.09|Standard Error of the Mean|0.22||0.6888|2-Sided|90.0|-0.28|0.45|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Weekl 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.|
1648957|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.24|Standard Error of the Mean|0.22||0.2778|2-Sided|90.0|-0.12|0.6|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||Overall Opinion: Week 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.|
1648958|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.23|Standard Error of the Mean|0.28|||2-Sided|90.0|-0.23|0.69||||||Surface Area: week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648959|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.69|Standard Error of the Mean|0.36|||2-Sided|90.0|0.09|1.28||||||Surface Area: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648960|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.01|Standard Error of the Mean|0.26|||2-Sided|90.0|-0.44|0.42||||||Surface Area : Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648961|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.64|Standard Error of the Mean|0.34|||2-Sided|90.0|0.08|1.2||||||Surface Area: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648962|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.15|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.53|0.23||||||Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648963|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.51|Standard Error of the Mean|0.3|||2-Sided|90.0|0.02|1.0||||||Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648964|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.08|Standard Error of the Mean|0.21|||2-Sided|90.0|-0.28|0.43||||||Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648965|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.17|Standard Error of the Mean|0.27|||2-Sided|90.0|-0.29|0.62||||||Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648966|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.49|Standard Error of the Mean|0.3|||2-Sided|90.0|0.0|0.98||||||Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648967|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.53|Standard Error of the Mean|0.31|||2-Sided|90.0|0.01|1.05||||||Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648968|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.02|Standard Error of the Mean|0.27|||2-Sided|90.0|-0.46|0.42||||||Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648969|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.73|Standard Error of the Mean|0.29|||2-Sided|90.0|0.25|1.2||||||Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648970|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.35|Standard Error of the Mean|0.25|||2-Sided|90.0|-0.76|0.05||||||Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648971|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.31|Standard Error of the Mean|0.26|||2-Sided|90.0|-0.12|0.74||||||Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648972|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.03|Standard Error of the Mean|0.22|||2-Sided|90.0|-0.39|0.34||||||Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648973|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.29|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.09|0.67||||||Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648974|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.15|Standard Error of the Mean|0.29|||2-Sided|90.0|-0.33|0.63||||||Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648975|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.52|Standard Error of the Mean|0.3|||2-Sided|90.0|0.02|1.02||||||Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648976|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.09|Standard Error of the Mean|0.3|||2-Sided|90.0|-0.41|0.59||||||Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648977|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.74|Standard Error of the Mean|0.31|||2-Sided|90.0|0.21|1.26||||||Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648978|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.19|Standard Error of the Mean|0.26|||2-Sided|90.0|-0.63|0.24||||||Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648979|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.22|Standard Error of the Mean|0.27|||2-Sided|90.0|-0.23|0.67||||||Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648980|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.11|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.5|0.28||||||Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648981|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.39|Standard Error of the Mean|0.24|||2-Sided|90.0|-0.01|0.78||||||Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648982|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.14|Standard Error of the Mean|0.32|||2-Sided|90.0|-0.38|0.67||||||Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648983|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.68|Standard Error of the Mean|0.34|||2-Sided|90.0|0.13|1.24||||||Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648984|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.21|Standard Error of the Mean|0.31|||2-Sided|90.0|-0.3|0.72||||||Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648985|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.94|Standard Error of the Mean|0.33|||2-Sided|90.0|0.4|1.49||||||Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648986|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.19|Standard Error of the Mean|0.25|||2-Sided|90.0|-0.62|0.23||||||Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1649240|NCT01728454|3033795|Superiority|||||||0.7507|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle|
1649241|NCT01728454|3033796|Superiority|||||||0.5821|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1|
1648987|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.4|Standard Error of the Mean|0.27|||2-Sided|90.0|-0.05|0.84||||||Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648988|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.03|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.42|0.35||||||Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648989|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.18|Standard Error of the Mean|0.24|||2-Sided|90.0|-0.22|0.58||||||Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648990|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.03|Standard Error of the Mean|0.21|||2-Sided|90.0|-0.39|0.32||||||Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648991|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.14|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.24|0.53||||||Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648992|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.02|Standard Error of the Mean|0.21|||2-Sided|90.0|-0.33|0.37||||||Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648993|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.03|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.35|0.41||||||Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648994|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.27|Standard Error of the Mean|0.2|||2-Sided|90.0|-0.6|0.06||||||Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648995|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.11|Standard Error of the Mean|0.21|||2-Sided|90.0|-0.47|0.24||||||Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648996|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.07|Standard Error of the Mean|0.17|||2-Sided|90.0|-0.35|0.22||||||Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648997|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.12|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.18|0.42||||||Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648998|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.22|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.09|0.52||||||Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1648999|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.33|Standard Error of the Mean|0.21|||2-Sided|90.0|-0.03|0.68||||||Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1649000|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.35|Standard Error of the Mean|0.18|||2-Sided|90.0|0.05|0.65||||||Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1649001|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.42|Standard Error of the Mean|0.21|||2-Sided|90.0|0.07|0.77||||||Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1649002|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.07|Standard Error of the Mean|0.17|||2-Sided|90.0|-0.22|0.36||||||Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1649003|NCT01730339|3033537|Superiority or Other||Least Square mean difference|0.19|Standard Error of the Mean|0.2|||2-Sided|90.0|-0.15|0.52||||||Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1649004|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.16|Standard Error of the Mean|0.16|||2-Sided|90.0|-0.43|0.11||||||Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1649005|NCT01730339|3033537|Superiority or Other||Least Square mean difference|-0.12|Standard Error of the Mean|0.19|||2-Sided|90.0|-0.43|0.2||||||Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871|
1649006|NCT01730339|3033538|Superiority or Other||Least Square mean difference|0.24|Standard Error of the Mean|0.29||0.4038|2-Sided|90.0|-0.24|0.72|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.|
1649007|NCT01730339|3033538|Superiority or Other||Least Square mean difference|0.68|Standard Error of the Mean|0.29||0.0219|2-Sided|90.0|0.19|1.16|||Repeated measures model|Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871||A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.|
1649008|NCT01730053|3033545|Superiority or Other (legacy)||LS Mean Difference|7.4|||=|0|2-Sided|98.75|-1.2|16.1||Threshold for significance ≤ 0.0125.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1649009|NCT01730053|3033546|Superiority or Other (legacy)||Adjusted Mean Difference|-23.6|||=|0|2-Sided|98.75|-39.0|-8.2||Threshold for significance ≤ 0.0125.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649032|NCT01730053|3033557|Superiority or Other (legacy)||LS Mean Difference|-30.7|||<|0.0001|2-Sided|98.75|-40.1|-21.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).|
1649010|NCT01730053|3033546|Superiority or Other (legacy)||Adjusted Mean Difference|-23.9|||<|0.0001|2-Sided|98.75|-38.6|-9.1||Threshold for significance ≤ 0.0125.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1649011|NCT01730053|3033547|Superiority or Other (legacy)||Odds Ratio (OR)|12.7|||=|0|2-Sided|98.75|2.4|67.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649012|NCT01730053|3033547|Superiority or Other (legacy)||Odds Ratio (OR)|20.3|||<|0.0001|2-Sided|98.75|2.4|67.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649013|NCT01730053|3033548|Superiority or Other (legacy)||Odds Ratio (OR)|11.6|||<|0.0001|2-Sided|98.75|2.5|53.1||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649014|NCT01730053|3033548|Superiority or Other (legacy)||Odds Ratio (OR)|18.6|||<|0.0001|2-Sided|98.75|3.6|96.2||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649015|NCT01730053|3033549|Superiority or Other (legacy)||Odds Ratio (OR)|9.9|||=|0|2-Sided|98.75|1.7|56.7||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649016|NCT01730053|3033549|Superiority or Other (legacy)||Odds Ratio (OR)|15.6|||<|0.0001|2-Sided|98.75|2.58|88.2||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649017|NCT01730053|3033550|Superiority or Other (legacy)||Odds Ratio (OR)|8.4|||=|0|2-Sided|98.75|1.8|40.5||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649018|NCT01730053|3033550|Superiority or Other (legacy)||Odds Ratio (OR)|12.4|||<|0.0001|2-Sided|98.75|2.6|59.5||Threshold for significance ≤ 0.0125.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649019|NCT01730053|3033551|Superiority or Other (legacy)||LS Mean Difference|-17.2|||<|0.0001|2-Sided|98.75|-26.7|-7.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649020|NCT01730053|3033551|Superiority or Other (legacy)||LS Mean Difference|-20.1|||<|0.0001|2-Sided|98.75|-29.4|-10.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).|
1649021|NCT01730053|3033552|Superiority or Other (legacy)||LS Mean Difference|-24.9|||<|0.0001|2-Sided|98.75|-37.7|-12.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649022|NCT01730053|3033552|Superiority or Other (legacy)||LS Mean Difference|-29.5|||<|0.0001|2-Sided|98.75|-42.1|-16.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).|
1649023|NCT01730053|3033553|Superiority or Other (legacy)||LS Mean Difference|-24.0|||<|0.0001|2-Sided|98.75|-35.7|-12.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649024|NCT01730053|3033553|Superiority or Other (legacy)||LS Mean Difference|-28.1|||<|0.0001|2-Sided|98.75|-39.7|-16.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).|
1649025|NCT01730053|3033554|Superiority or Other (legacy)||LS Mean Difference|-20.3|||<|0.0001|2-Sided|98.75|-29.3|-11.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649026|NCT01730053|3033554|Superiority or Other (legacy)||LS Mean Difference|-20.6|||<|0.0001|2-Sided|98.75|-29.4|-11.8||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).|
1649027|NCT01730053|3033555|Superiority or Other (legacy)||LS Mean Difference|-28.2|||<|0.0001|2-Sided|98.75|-39.1|-17.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649028|NCT01730053|3033555|Superiority or Other (legacy)||LS Mean Difference|-32.8|||<|0.0001|2-Sided|98.75|-43.2|-22.4||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).|
1649029|NCT01730053|3033556|Superiority or Other (legacy)||LS Mean Difference|-29.3|||<|0.0001|2-Sided|98.75|-42.1|-16.4||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649030|NCT01730053|3033556|Superiority or Other (legacy)||LS Mean Difference|-31.4|||<|0.0001|2-Sided|98.75|-43.9|-18.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).|
1649031|NCT01730053|3033557|Superiority or Other (legacy)||LS Mean Difference|-28.3|||<|0.0001|2-Sided|98.75|-38.0|-18.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649242|NCT01728454|3033796|Superiority|||||||0.3993|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1|
1649243|NCT01728454|3033796|Superiority|||||||0.5507|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1|
1649033|NCT01730053|3033558|Superiority or Other (legacy)||LS Mean Difference|-26.8|||<|0.0001|2-Sided|98.75|-37.9|-15.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649034|NCT01730053|3033558|Superiority or Other (legacy)||LS Mean Difference|-29.2|||<|0.0001|2-Sided|98.75|-40.1|-18.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).|
1649035|NCT01730053|3033559|Superiority or Other (legacy)||LS Mean Difference|-32.3|||<|0.0001|2-Sided|98.75|-45.6|-19.0||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649036|NCT01730053|3033559|Superiority or Other (legacy)||LS Mean Difference|-35.3|||<|0.0001|2-Sided|98.75|-48.2|-22.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).|
1649037|NCT01730053|3033560|Superiority or Other (legacy)||LS Mean Difference|-32.2|||<|0.0001|2-Sided|98.75|-47.0|-17.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649038|NCT01730053|3033560|Superiority or Other (legacy)||LS Mean Difference|-35.2|||<|0.0001|2-Sided|98.75|-47.4|-17.9||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant for rosuvastatin 10 mg baseline stratification).|
1649039|NCT01730053|3033561|Superiority or Other (legacy)||LS Mean Difference|-24.5|||=|0|2-Sided|98.75|-49.2|0.2||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649040|NCT01730053|3033561|Superiority or Other (legacy)||LS Mean Difference|-33.2|||<|0.0001|2-Sided|98.75|-45.9|-20.5||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649041|NCT01730053|3033561|Superiority or Other (legacy)||LS Mean Difference|-35.2|||<|0.0001|2-Sided|98.75|-47.4|-23.0||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1.25 % level.|
1649042|NCT01730053|3033562|Superiority or Other (legacy)||LS Mean Difference|-25.3|||=|0|2-Sided|98.75|-50.9|0.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.|
1649043|NCT01730053|3033562|Superiority or Other (legacy)||LS Mean Difference|-20.3|||=|0|2-Sided|98.75|-45.8|5.1||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.|
1649044|NCT01730053|3033562|Superiority or Other (legacy)||LS Mean Difference|-36.1|||<|0.0001|2-Sided|98.75|-51.5|-20.7||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.|
1649045|NCT01730053|3033562|Superiority or Other (legacy)||LS Mean Difference|-34.2|||<|0.0001|2-Sided|98.75|-49.2|-19.3||Threshold for significance ≤ 0.0125.|Mixed Models Analysis|||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.|
1649046|NCT01730040|3033569|Superiority or Other||LS Mean Difference|2.9|||=|0|2-Sided|99.0|-7.0|12.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification).|
1649047|NCT01730040|3033570|Superiority or Other||Adjusted Mean Difference|-31.0|||<|0.0001|2-Sided|99.0|-45.6|-16.4||Threshold for significance ≤ 0.01.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649048|NCT01730040|3033570|Superiority or Other||Adjusted Mean Difference|-25.9|||<|0.0001|2-Sided|99.0|-40.2|-11.6||Threshold for significance ≤ 0.01.|Regression, Robust|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649049|NCT01730040|3033570|Superiority or Other||Adjusted Mean Difference|-21.1|||=|0|2-Sided|99.0|-36.3|-5.9||Threshold for significance ≤ 0.01.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1649050|NCT01730040|3033571|Superiority or Other||Odds Ratio (OR)|13.9|||=|0|2-Sided|99.0|2.2|88.1||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649051|NCT01730040|3033571|Superiority or Other||Odds Ratio (OR)|19.8|||<|0.0001|2-Sided|99.0|3.1|126.3||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649052|NCT01730040|3033571|Superiority or Other||Odds Ratio (OR)|162.1|||<|0.0001|2-Sided|99.0|17.3|1520.5||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649053|NCT01730040|3033572|Superiority or Other||Odds Ratio (OR)|9.9|||=|0|2-Sided|99.0|1.9|51.9||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649054|NCT01730040|3033572|Superiority or Other||Odds Ratio (OR)|13.2|||<|0.0001|2-Sided|99.0|2.5|68.8||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649055|NCT01730040|3033572|Superiority or Other||Odds Ratio (OR)|116.8|||<|0.0001|2-Sided|99.0|14.7|927.5||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649056|NCT01730040|3033573|Superiority or Other||Odds Ratio (OR)|13.7|||=|0|2-Sided|99.0|1.8|101.1||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649057|NCT01730040|3033573|Superiority or Other||Odds Ratio (OR)|10.9|||=|0|2-Sided|99.0|1.6|75.4||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649058|NCT01730040|3033573|Superiority or Other||Odds Ratio (OR)|128.4|||<|0.0001|2-Sided|99.0|14.2|1157.0||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant) for atorvastatin 40 mg baseline stratification). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649059|NCT01730040|3033574|Superiority or Other||Odds Ratio (OR)|9.1|||=|0|2-Sided|99.0|1.6|52.2||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649060|NCT01730040|3033574|Superiority or Other||Odds Ratio (OR)|7.2|||=|0|2-Sided|99.0|1.3|38.3||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649061|NCT01730040|3033574|Superiority or Other||Odds Ratio (OR)|83.2|||<|0.0001|2-Sided|99.0|11.6|596.8||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649062|NCT01730040|3033574|Superiority or Other||Odds Ratio (OR)|3.4|||=|0|2-Sided|99.0|0.8|14.6||Threshold for significance ≤ 0.01.|Regression, Logistic|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649063|NCT01730040|3033574|Superiority or Other||Odds Ratio (OR)|16.7|||<|0.0001|2-Sided|99.0|3.9|71.7||Threshold for significance ≤ 0.01.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649064|NCT01730040|3033575|Superiority or Other||LS Mean Difference|-9.8|||=|0|2-Sided|99.0|-17.7|-1.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649065|NCT01730040|3033575|Superiority or Other||LS Mean Difference|-15.4|||<|0.0001|2-Sided|99.0|-23.3|-7.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649066|NCT01730040|3033575|Superiority or Other||LS Mean Difference|-19.1|||<|0.0001|2-Sided|99.0|-26.9|-11.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649067|NCT01730040|3033575|Superiority or Other||LS Mean Difference|-15.8|||<|0.0001|2-Sided|99.0|-24.6|-7.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649068|NCT01730040|3033575|Superiority or Other||LS Mean Difference|-22.6|||<|0.0001|2-Sided|99.0|-31.4|-13.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649069|NCT01730040|3033576|Superiority or Other||LS Mean Difference|-14.8|||<|0.0001|2-Sided|99.0|-24.7|-4.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649070|NCT01730040|3033576|Superiority or Other||LS Mean Difference|-22.5|||<|0.0001|2-Sided|99.0|-32.3|-12.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649071|NCT01730040|3033576|Superiority or Other||LS Mean Difference|-29.3|||<|0.0001|2-Sided|99.0|-39.0|-19.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649072|NCT01730040|3033576|Superiority or Other||LS Mean Difference|-23.4|||<|0.0001|2-Sided|99.0|-35.2|-11.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649073|NCT01730040|3033576|Superiority or Other||LS Mean Difference|-33.5|||<|0.0001|2-Sided|99.0|-45.3|-21.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649074|NCT01730040|3033577|Superiority or Other||LS Mean Difference|-15.9|||<|0.0001|2-Sided|99.0|-25.2|-6.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649075|NCT01730040|3033577|Superiority or Other||LS Mean Difference|-22.2|||<|0.0001|2-Sided|99.0|-31.5|-12.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649076|NCT01730040|3033577|Superiority or Other||LS Mean Difference|-26.7|||<|0.0001|2-Sided|99.0|-35.9|-17.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649077|NCT01730040|3033577|Superiority or Other||LS Mean Difference|-25.3|||<|0.0001|2-Sided|99.0|-35.4|-15.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649078|NCT01730040|3033577|Superiority or Other||LS Mean Difference|-31.5|||<|0.0001|2-Sided|99.0|-41.6|-21.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649079|NCT01730040|3033578|Superiority or Other||LS Mean Difference|-18.4|||<|0.0001|2-Sided|99.0|-29.1|-7.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649080|NCT01730040|3033578|Superiority or Other||LS Mean Difference|-21.9|||<|0.0001|2-Sided|99.0|-32.4|-11.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649081|NCT01730040|3033578|Superiority or Other||LS Mean Difference|-28.9|||<|0.0001|2-Sided|99.0|-39.4|-18.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649082|NCT01730040|3033578|Superiority or Other||LS Mean Difference|-15.8|||<|0.0001|2-Sided|99.0|-25.8|-5.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649083|NCT01730040|3033578|Superiority or Other||LS Mean Difference|-23.1|||<|0.0001|2-Sided|99.0|-32.9|-13.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649084|NCT01730040|3033579|Superiority or Other||LS Mean Difference|-27.3|||<|0.0001|2-Sided|99.0|-41.4|-13.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649085|NCT01730040|3033579|Superiority or Other||LS Mean Difference|-32.1|||<|0.0001|2-Sided|99.0|-46.0|-18.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649086|NCT01730040|3033579|Superiority or Other||LS Mean Difference|-43.6|||<|0.0001|2-Sided|99.0|-57.4|-29.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649087|NCT01730040|3033579|Superiority or Other||LS Mean Difference|-22.4|||<|0.0001|2-Sided|99.0|-36.6|-8.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649088|NCT01730040|3033579|Superiority or Other||LS Mean Difference|-33.0|||<|0.0001|2-Sided|99.0|-47.0|-19.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649089|NCT01730040|3033580|Superiority or Other||LS Mean Difference|-26.6|||<|0.0001|2-Sided|99.0|-40.3|-12.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649090|NCT01730040|3033580|Superiority or Other||LS Mean Difference|-30.2|||<|0.0001|2-Sided|99.0|-43.7|-16.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649091|NCT01730040|3033580|Superiority or Other||LS Mean Difference|-41.1|||<|0.0001|2-Sided|99.0|-54.7|-27.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649092|NCT01730040|3033580|Superiority or Other||LS Mean Difference|-21.6|||=|0|2-Sided|99.0|-36.1|-7.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649093|NCT01730040|3033580|Superiority or Other||LS Mean Difference|-30.4|||<|0.0001|2-Sided|99.0|-44.7|-16.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649094|NCT01730040|3033581|Superiority or Other||LS Mean Difference|-26.4|||<|0.0001|2-Sided|99.0|-39.4|-13.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649095|NCT01730040|3033581|Superiority or Other||LS Mean Difference|-29.8|||<|0.0001|2-Sided|99.0|-42.6|-17.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649096|NCT01730040|3033581|Superiority or Other||LS Mean Difference|-38.3|||<|0.0001|2-Sided|99.0|-51.2|-25.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649097|NCT01730040|3033581|Superiority or Other||LS Mean Difference|-25.1|||<|0.0001|2-Sided|99.0|-37.3|-12.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649098|NCT01730040|3033581|Superiority or Other||LS Mean Difference|-32.6|||<|0.0001|2-Sided|99.0|-44.6|-20.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649099|NCT01730040|3033582|Superiority or Other||LS Mean Difference|-27.6|||<|0.0001|2-Sided|99.0|-40.1|-15.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649100|NCT01730040|3033582|Superiority or Other||LS Mean Difference|-30.9|||<|0.0001|2-Sided|99.0|-43.2|-18.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649101|NCT01730040|3033582|Superiority or Other||LS Mean Difference|-38.4|||<|0.0001|2-Sided|99.0|-50.8|-26.0||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649102|NCT01730040|3033582|Superiority or Other||LS Mean Difference|-23.6|||<|0.0001|2-Sided|99.0|-36.6|-10.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649103|NCT01730040|3033582|Superiority or Other||LS Mean Difference|-29.3|||<|0.0001|2-Sided|99.0|-42.0|-16.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649104|NCT01730040|3033583|Superiority or Other||LS Mean Difference|-20.2|||<|0.0001|2-Sided|99.0|-32.2|-8.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649105|NCT01730040|3033583|Superiority or Other||LS Mean Difference|-27.7|||<|0.0001|2-Sided|99.0|-39.6|-15.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649106|NCT01730040|3033583|Superiority or Other||LS Mean Difference|-36.3|||<|0.0001|2-Sided|99.0|-48.1|-24.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649107|NCT01730040|3033583|Superiority or Other||LS Mean Difference|-26.6|||<|0.0001|2-Sided|99.0|-38.0|-15.2||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649108|NCT01730040|3033583|Superiority or Other||LS Mean Difference|-44.5|||<|0.0001|2-Sided|99.0|-55.8|-33.1||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649109|NCT01730040|3033584|Superiority or Other||LS Mean Difference|-20.9|||<|0.0001|2-Sided|99.0|-32.8|-8.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649110|NCT01730040|3033584|Superiority or Other||LS Mean Difference|-27.3|||<|0.0001|2-Sided|99.0|-39.2|-15.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649111|NCT01730040|3033584|Superiority or Other||LS Mean Difference|-36.0|||<|0.0001|2-Sided|99.0|-47.7|-24.3||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649112|NCT01730040|3033584|Superiority or Other||LS Mean Difference|-25.8|||<|0.0001|2-Sided|99.0|-40.0|-11.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649113|NCT01730040|3033584|Superiority or Other||LS Mean Difference|-39.8|||<|0.0001|2-Sided|99.0|-54.0|-25.6||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649114|NCT01730040|3033585|Superiority or Other||LS Mean Difference|-33.4|||<|0.0001|2-Sided|99.0|-50.0|-16.8||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649115|NCT01730040|3033585|Superiority or Other||LS Mean Difference|-35.0|||<|0.0001|2-Sided|99.0|-51.3|-18.6|||Mixed Models Analysis|Threshold for significance ≤ 0.01.||Analysis description as per the statistical analysis 1 of this endpoint.|
1649116|NCT01730040|3033585|Superiority or Other||LS Mean Difference|-52.8|||<|0.0001|2-Sided|99.0|-69.2|-36.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649117|NCT01730040|3033585|Superiority or Other||LS Mean Difference|-24.9|||=|0|2-Sided|99.0|-41.9|-7.8||Threshold for significance≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649118|NCT01730040|3033585|Superiority or Other||LS Mean Difference|-42.5|||<|0.0001|2-Sided|99.0|-59.2|-25.7||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 1% level.|
1649119|NCT01730040|3033586|Superiority or Other||LS Mean Difference|-31.4|||<|0.0001|2-Sided|99.0|-47.4|-15.4||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649120|NCT01730040|3033586|Superiority or Other||LS Mean Difference|-32.6|||<|0.0001|2-Sided|99.0|-48.4|-16.9||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649121|NCT01730040|3033586|Superiority or Other||LS Mean Difference|-49.2|||<|0.0001|2-Sided|99.0|-65.0|-33.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||Analysis description as per the statistical analysis 1 of this endpoint.|
1649122|NCT01730040|3033586|Superiority or Other||LS Mean Difference|-23.6|||=|0|2-Sided|99.0|-40.7|-6.5||Threshold for significance ≤ 0.01.|Mixed Models Analysis|||As described in statistical analysis 1 of the endpoint.|
1649123|NCT01730040|3033586|Superiority or Other||LS Mean Difference|-39.1|||<|0.0001|2-Sided|99.0|-55.9|-22.2|||Mixed Models Analysis|Threshold for significance ≤ 0.01.||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.|
1649124|NCT01729819|3033604|Superiority|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Mean Difference (Final Values)|0.28||||0.36|2-Sided|95.0|-0.32|0.88|||ANCOVA|Longitudinal analysis of covariance on change from baseline with baseline as a covariate, and treatment and visit as factors.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented. Statistical analysis for Rate the quality of your sleep last night"|
1649125|NCT01729819|3033604|Superiority||Mean Difference (Final Values)|0.34||||0.257|2-Sided|95.0|-0.26|0.94|||ANCOVA|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented. Statistical analysis for Rate how refreshed you feel now"|
1649126|NCT01729819|3033604|Superiority||Mean Difference (Final Values)|0.42||||0.178|2-Sided|95.0|-0.2|1.05|||ANCOVA|Quality of sleep rating score as dependent variable, baseline quality of sleep rating scale value as a covariate, and responder status as a factor.|Estimated contrast (Combination - tolterodine) from longitudinal analysis of covariance|"Combination versus tolterodine (i.e. score on scale in combination group versus score on scale in tolterodine group) is presented.Statistical analysis for from very tired to wide awake, how do you feel now"|
1649127|NCT01729819|3033605|Superiority|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.106||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids for the duration of 3 months|ANCOVA|||Treatment difference (Combination-tolterodine) for the duration of 3 months|
1649128|NCT01729819|3033605|Superiority|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.055||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids at Month 3|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 3|
1649129|NCT01729819|3033605|Superiority|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.086||||||Adjusted treatment difference in mean number of nocturnal voids (Combination-tolterodine) at Month 2|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 2|
1649130|NCT01729819|3033605|Superiority|Estimated contrast (Combination - tolterodine) from longitudinal analysis including a treatment-by visit interaction term||||||0.443||||||Adjusted treatment difference (Combination-tolterodine) in mean number of nocturnal voids at Month 1|ANCOVA|||Treatment difference (Combination-tolterodine) at Month 1|
1649131|NCT01729819|3033606|Superiority||Odds Ratio (OR)|1.36||||0.352|2-Sided|95.0|0.71|2.62||33% responder status as dependent variable, baseline mean nocturnal voids as covariate, treatment, and visit as factors.|Generalized Estimating Equation|||Combination versus tolterodine (i.e. odds of being responder in combination group versus odds of being responder in tolterodine group) is presented. The proportion of responders during three months of treatment was analysed (i.e. the odds ratio of the odds of being a responder) longitudinally using Generalised Estimating Equation (GEE) for a repeated logistic regression.|
1649244|NCT01728454|3033796|Superiority|||||||0.7508|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1|
1649245|NCT01728454|3033797|Superiority|||||||0.1927|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1|
1649132|NCT01729819|3033607|Superiority||Mean Difference (Final Values)|-64.16||||0.103|2-Sided|95.0|-141.46|13.14|||ANCOVA|Change in mean nocturnal volume as the dependent variable and baseline mean nocturnal volume as a covariate, and treatment and visit as factors.|The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented|
1649133|NCT01729819|3033608|Superiority||Mean Difference (Final Values)|18.0||||0.385|2-Sided|95.0|-22.96|58.96|||ANCOVA|Change in mean time to first void as dependent variable and baseline mean time to first void as a covariate, and treatment and visit as factors.|The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented.|
1649134|NCT01729819|3033609|Superiority|The change in mean nocturnal voids from baseline as the dependent variable, baseline mean nocturnal voids as a covariate, and treatments and visit (Month 1, Month 2, and Month 3) as factors, was considered for the analysis. Longitudinal analysis based on repeated measures using analysis of covariance with subject as random effect. Missing values post-baseline were not imputed.|Mean Difference (Final Values)|-0.34||||0.112|2-Sided|95.0|-0.77|0.08|||ANCOVA|Change in mean nocturnal voids as the dependent variable and baseline mean nocturnal voids as a covariate, treatment and visit as factors.|Longitudinal analysis based on repeated measures using analysis of covariance with subject as random effect. The estimated value represents the contrast of combination - tolterodine.|Combination versus tolterodine (i.e. effect in combination group minus effect in tolterodine group) is presented. The trial was to be declared positive if a statistically significant (two-sided, p < 0.05) positive effect for combining tolterodine and desmopressin compared to tolterodine monotherapy on the primary endpoint had been demonstrated.|
1649135|NCT01729754|3033618|Other||Difference in percentages|15.0|||<|0.001|2-Sided|95.0|6.9|22.9|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649136|NCT01729754|3033618|Other||Difference in percentages|25.7|||<|0.001|2-Sided|95.0|17.7|33.4|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649137|NCT01729754|3033619|Other||Difference in percentages|4.8||||0.221|2-Sided|95.0|-2.9|12.5|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649138|NCT01729754|3033619|Other||Difference in percentages|11.9||||0.003|2-Sided|95.0|4.1|19.5|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649139|NCT01729754|3033619|Other||Difference in percentages|32.1|||<|0.001|2-Sided|95.0|24.5|39.1|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649140|NCT01729754|3033619|Other||Difference in percentages|39.3|||<|0.001|2-Sided|95.0|31.8|46.1|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649141|NCT01729754|3033622|Other||Difference in least squares means|-2.2|||<|0.001|2-Sided|95.0|-2.9|-1.5|||cLDA|Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).|||
1649142|NCT01729754|3033622|Other||Difference in least squares means|-1.7|||<|0.001|2-Sided|95.0|-2.4|-1.0|||cLDA|Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).|||
1649143|NCT01729754|3033623|Other||Difference in least squares means|-1.4||||0.001|2-Sided|95.0|-2.2|-0.6|||cLDA|Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).|||
1649144|NCT01729754|3033623|Other||Difference in least squares means|-1.3||||0.002|2-Sided|95.0|-2.1|-0.5|||cLDA|Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).|||
1649145|NCT01729754|3033623|Other||Difference in least squares means|-8.3|||<|0.001|2-Sided|95.0|-9.3|-7.3|||cLDA|Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).|||
1649146|NCT01729754|3033623|Other||Difference in least squares means|-8.2|||<|0.001|2-Sided|95.0|-9.3|-7.2|||cLDA|Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).|||
1649147|NCT01729754|3033627|Superiority||Difference in percentages|11.7|||<|0.001|2-Sided|95.0|5.6|17.9|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649189|NCT01728584|3033779|Superiority or Other||Difference in LS Means|-0.61||||0.073|2-Sided|95.0|-1.27|0.06||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB||
1649246|NCT01728454|3033797|Superiority|||||||0.1017|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1|
1649148|NCT01729754|3033627|Superiority||Difference in percentages|15.7|||<|0.001|2-Sided|95.0|9.4|22.1|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649149|NCT01729754|3033628|Superiority||Difference in percentages|7.6|||<|0.001|2-Sided|95.0|3.3|12.3|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649150|NCT01729754|3033628|Superiority||Difference in percentages|7.0|||<|0.001|2-Sided|95.0|2.8|11.6|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649151|NCT01729754|3033628|Superiority||Difference in percentages|12.4|||<|0.001|2-Sided|95.0|8.5|16.6|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649152|NCT01729754|3033628|Superiority||Difference in percentages|11.7|||<|0.001|2-Sided|95.0|7.8|16.0|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649153|NCT01729754|3033631|Other||Difference in percentages|24.9|||<|0.001|2-Sided|95.0|17.0|32.6|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649154|NCT01729754|3033631|Other||Difference in percentages|27.1|||<|0.001|2-Sided|95.0|19.1|34.7||Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649155|NCT01729754|3033632|Superiority||Difference in percentages|17.4|||<|0.001|2-Sided|95.0|10.3|24.4|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649156|NCT01729754|3033632|Superiority||Difference in percentages|15.2|||<|0.001|2-Sided|95.0|8.3|22.1|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649157|NCT01729754|3033632|Superiority||Difference in percentages|37.5|||<|0.001|2-Sided|95.0|31.1|43.4|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights||
1649158|NCT01729754|3033632|Superiority||Difference in percentages|35.3|||<|0.001|2-Sided|95.0|29.2|41.1|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649159|NCT01729754|3033635|Superiority||Difference in percentages|19.6|||<|0.001|2-Sided|95.0|11.7|27.3|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights||
1649160|NCT01729754|3033635|Superiority||Difference in percentages|24.1|||<|0.001|2-Sided|95.0|16.2|31.7|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649161|NCT01729754|3033638|Superiority||Difference in percentages|20.1|||<|0.001|2-Sided|95.0|12.4|27.6||Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649162|NCT01729754|3033638|Superiority||Difference in percentages|19.2|||<|0.001|2-Sided|95.0|11.5|26.7||Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649190|NCT01728584|3033780|Superiority or Other||Difference in LS Means|1.12||||0.006|2-Sided|95.0|0.32|1.92||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB||
1649163|NCT01729754|3033641|Superiority||Difference in percentages|50.2|||<|0.001|2-Sided|95.0|43.2|56.5||Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Cochran-Mantel-Haenszel||Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649164|NCT01729754|3033641|Superiority||Difference in percentages|54.7|||<|0.001|2-Sided|95.0|47.9|60.8|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649165|NCT01729754|3033642|Superiority||Difference in percentages|55.5|||<|0.001|2-Sided|95.0|48.3|61.8|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and CIs are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649166|NCT01729754|3033642|Superiority||Difference in percentages|59.8|||<|0.001|2-Sided|95.0|52.9|65.9|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|Difference and confidence intervals (CIs) are calculated using Miettinen-Nurminen stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no) with sample size weights.||
1649167|NCT01729598|3033697|Superiority|||||||0.31|||||||t-test, 2 sided||||
1649168|NCT01729598|3033698|Superiority|||||||0.02|||||||t-test, 2 sided||||
1649169|NCT01729598|3033699|Superiority|||||||0.19|||||||t-test, 2 sided||||
1649170|NCT01729598|3033700|Superiority|||||||0.55|||||||t-test, 2 sided||||
1649171|NCT01729559|3033705|Non-Inferiority or Equivalence|A 10% noninferiority margin was selected based on these data showing a difference in the incidence of DVT of 13% with the use of 30 mg of enoxaparin every 12 hours compared to 5,000 U of UFH every 12 hours. To achieve 90% power using an a priori margin of 10% with a one-sided alpha of 0.025, a total of 182 patients (91 in each arm) was required. This analysis was performed in the entire sample.|Risk Difference (RD)|3.1||||0.025|2-Sided|95.0|-1.6|7.7||One-tailed test of the cumulative VTE incidence between treatment groups.|Chi-squared, Corrected||Unadjusted cumulative incidence values between the two treatment groups were subtracted to calculate the risk difference for VTE between groups. This difference was compared to the a priori 10% margin of difference using the 95% confidence interval.|"Analysis was performed in the total sample of eligible patients and who received their assigned treatment (referred to as the randomized treated sample) ."|
1649172|NCT01729559|3033705|Non-Inferiority or Equivalence|A 10% noninferiority margin was selected based on a previous trial showing a difference in the incidence of DVT of 13% with the use of 30 mg of enoxaparin every 12 hours compared to 5,000 U of unfractionated heparin (UFH) every 12 hr. To achieve 90% power using an a priori margin of 10% with a one-sided alpha of 0.025, a total of 182 patients (91 in each arm) was required.|Risk Difference (RD)|6.5||||0.025|2-Sided|95.0|-2.9|15.8||One-tailed test of the cumulative VTE incidence between treatment groups.|Chi-squared, Corrected||Unadjusted cumulative incidence values between the two treatment groups were subtracted to calculate the risk difference for VTE between groups. This difference was compared to the a priori 10% margin of difference using the 95% confidence interval.|Analysis was performed in a subset of patients who received at least one follow-up venous duplex ultrasound of the lower extremities.|
1649173|NCT01729338|3033708|Superiority or Other|||||||0.09|||||||paired t-test|baseline, month 5|||
1649174|NCT01729338|3033708|Superiority or Other|||||||0.1||||||baseline, 3 month|paired t-test||||
1649175|NCT01729338|3033709|Superiority or Other|||||||0.19|||||||paired t-test|compares baseline to month 5|||
1649176|NCT01729338|3033709|Superiority or Other|||||||0.45||||||Compared baseline to 3 months|paired t-test||||
1649177|NCT01729039|3033743|Superiority|||||||0.146||||||Interaction of Time by Grou (GS vs. CON) alpha = .05|ANOVA||||
1649178|NCT01729039|3033743|Superiority|||||||0.009||||||Main effect of time (baseline to post-PT) alpha = .05|ANOVA||||
1649179|NCT01729039|3033744|Superiority|||||||0.172||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA||||
1649180|NCT01729039|3033744|Superiority|||||||0.005||||||Main effect of Time (baseline to post-PT) alpha = .05|ANOVA||||
1649181|NCT01729039|3033745|Superiority|||||||0.817||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA||||
1649182|NCT01729039|3033745|Superiority||||||<|0.001|||||||ANOVA|Main effect of Time (baseline to post-PT) alpha = .05|||
1649183|NCT01729039|3033746|Superiority|||||||0.297||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA||||
1649184|NCT01729039|3033746|Superiority|||||||0.17||||||Main effect of Time (baseline to post-PT) Alpha=.05|ANOVA||||
1649185|NCT01729039|3033747|Superiority|||||||0.84||||||Interaction of Time by Group (GS vs. CON) alpha = .05|ANOVA||||
1649186|NCT01729039|3033747|Superiority|||||||0.356||||||Main effect of time (baseline to post-PT) alpha = .05|ANOVA||||
1649187|NCT01729026|3033760|Superiority or Other||Effect size (Cohen's d)|0.7||||0.1414|2-Sided|||||Between baseline and 3-month follow-up, subjects in the Adoption group had a mean improvement of 15.2 points on the PCL-5 compared to 7.8 points in the Wait-list group.|Mixed effects regression models|||The analyses were mixed effect regression models with repeated measures at randomization (baseline) and at the 3-month post-randomization follow-up using a 2 x 2 design. Treatment (Adoption group vs Wait-list group), time (baseline and 3-month follow-up) and their interaction were the fixed design effects. The treatment by time interaction tests the significance of the difference between baseline and 3-month follow-up between the Adoption and Wait-list groups.|
1649188|NCT01728584|3033778|Superiority or Other||Difference in LS Means|0.74||||0.009|2-Sided|95.0|0.19|1.28||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB||
1649226|NCT01728454|3033789|Superiority|||||||0.3591|||||||Wilcoxon Rank- Sum Test|||PTS: ODI Cycle 1|
1649227|NCT01728454|3033789|Superiority|||||||0.1302|||||||Wilcoxon Rank- Sum Test|||PTS: LOCF Cycle 1|
1649191|NCT01728584|3033781|Superiority or Other||Difference in LS Means|0.82||||0.004|2-Sided|95.0|0.27|1.37||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB||
1649192|NCT01728584|3033782|Superiority or Other||Difference in LS Means|0.91||||0.063|2-Sided|95.0|-0.05|1.87||Not controlled for multiple testing|ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is deep versus standard NMB||
1649193|NCT01728584|3033783|Superiority or Other||Difference in LS Means|0.49|||||2-Sided|95.0|-0.17|1.16|||||Difference is deep NMB/standard pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon|
1649194|NCT01728584|3033783|Superiority or Other||Difference in LS Means|0.05|||||2-Sided|95.0|-0.69|0.78|||||Difference is standard NMB/low pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon|
1649195|NCT01728584|3033783|Superiority or Other||Difference in LS Means|-0.45|||||2-Sided|95.0|-1.15|0.26|||||Difference is standard NMB/low pressure versus deep NMB/standard pressure|ANOVA model included factors treatment group, gender and surgeon|
1649196|NCT01728584|3033783|Superiority or Other||Difference in LS Means|-0.15|||||2-Sided|95.0|-0.84|0.53|||||Difference is standard NMB/standard pressure versus deep NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon|
1649197|NCT01728584|3033783|Superiority or Other||Difference in LS Means|-0.65|||||2-Sided|95.0|-1.27|-0.02|||||Difference is standard NMB/standard pressure versus deep NMB/standard pressure|ANOVA model included factors treatment group, gender and surgeon|
1649198|NCT01728584|3033783|Superiority or Other||Difference in LS Means|-0.2|||||2-Sided|95.0|-0.92|0.52|||||Difference is standard NMB/standard pressure versus standard NMB/low pressure|ANOVA model included factors treatment group, gender and surgeon|
1649199|NCT01728584|3033784|Superiority or Other||Difference in LS Means|-0.17||||0.494|2-Sided|95.0|-0.67|0.33||To control for multiple testing, this difference was formally tested only if comparison of surgeon’s overall satisfaction with surgical conditions for deep versus standard NMB was significant at the 5% level, with greater satisfaction for deep NMB.|ANOVA|ANOVA model included factors depth of NMB, level of pressure, gender and surgeon|Difference is low versus standard pressure|Key secondary hypothesis – low insufflation pressure improves overall average pain score in first 24 hours compared to standard insufflation pressure|
1649200|NCT01728584|3033784|Superiority or Other||Difference in LS Means|0.35||||0.148|2-Sided|95.0|-0.13|0.84|||ANOVA|Analysis of variance (ANOVA) model included factors depth of NMB, level of pressure, gender and surgeon|Difference is deep versus standard NMB||
1649201|NCT01728584|3033785|Superiority or Other||Difference in LS Means|2.41|||||2-Sided|95.0|1.08|3.74|||||Difference is deep NMB/standard pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|
1649202|NCT01728584|3033785|Superiority or Other||Difference in LS Means|-1.7|||||2-Sided|95.0|-3.01|-0.38|||||Difference is standard NMB/low pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|
1649203|NCT01728584|3033785|Superiority or Other||Difference in LS Means|-4.1|||||2-Sided|95.0|-5.42|-2.78|||||Difference is standard NMB/low pressure versus deep NMB/standard pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|
1649204|NCT01728584|3033785|Superiority or Other||Difference in LS Means|1.96|||||2-Sided|95.0|0.57|3.36|||||Difference is standard NMB/standard pressure versus deep NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|
1649205|NCT01728584|3033785|Superiority or Other||Difference in LS Means|-0.44|||||2-Sided|95.0|-1.8|0.91|||||Difference is standard NMB/standard pressure versus deep NMB/standard pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|
1649206|NCT01728584|3033785|Superiority or Other||Difference in Least Squares (LS) Means|3.66|||||2-Sided|95.0|2.3|5.02|||||Difference is standard NMB/standard pressure versus standard NMB/low pressure|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|
1649207|NCT01728584|3033786|Superiority or Other||Difference in LS Means|-3.02|||<|0.001|2-Sided|95.0|-3.99|-2.05|||ANCOVA|ANCOVA model included factors depth of NMB, level of pressure, surgeon and BMI|Difference is low versus standard pressure||
1649208|NCT01728584|3033786|Superiority or Other||Difference in Least Squares (LS) Means|1.09|||<|0.026|2-Sided|95.0|0.13|2.04|||ANCOVA|Analysis of covariance (ANCOVA) model included factors depth of NMB, level of pressure, surgeon and body mass index (BMI)|Difference is deep versus standard NMB|Primary hypothesis – deep NMB improves surgeon’s overall satisfaction with the surgical conditions compared to standard NMB|
1649209|NCT01728454|3033787|Superiority|||||||0.7503|||||||Wilcoxon Rank- Sum Test|||EP: Off-Drug Cycle 1|
1649210|NCT01728454|3033787|Superiority|||||||0.3162|||||||Wilcoxon Rank- Sum Test|||EP: Off-Drug Cycle 1|
1649211|NCT01728454|3033787|Superiority|||||||0.2985|||||||Wilcoxon Rank- Sum Test|||EP: On-Drug Cycle 1|
1649212|NCT01728454|3033787|Superiority|||||||0.7143|||||||Wilcoxon Rank- Sum Test|||EP: On-Drug Cycle 1|
1649213|NCT01728454|3033787|Superiority|||||||0.6552|||||||Wilcoxon Rank- Sum Test|||SAP: Off-Drug Cycle 1|
1649214|NCT01728454|3033787|Superiority|||||||0.9376|||||||Wilcoxon Rank- Sum Test|||SAP: Off-Drug Cycle 1|
1649215|NCT01728454|3033787|Superiority|||||||0.7881|||||||Wilcoxon Rank- Sum Test|||SAP: On-Drug Cycle 1|
1649216|NCT01728454|3033787|Superiority|||||||0.6131|||||||Wilcoxon Rank- Sum Test|||SAP: On-Drug Cycle 1|
1649217|NCT01728454|3033788|Superiority|||||||0.4252|||||||Wilcoxon Rank- Sum Test|||ODI Cycle 1|
1649218|NCT01728454|3033788|Superiority|||||||0.4116|||||||Wilcoxon Rank- Sum Test|||ODI Cycle 1|
1649219|NCT01728454|3033788|Superiority|||||||0.5858|||||||Wilcoxon Rank- Sum Test|||LOCF Cycle 1|
1649220|NCT01728454|3033788|Superiority|||||||0.2812|||||||Wilcoxon Rank- Sum Test|||LOCF Cycle 1|
1649221|NCT01728454|3033789|Superiority|||||||0.9527|||||||Wilcoxon Rank- Sum Test|||IS: ODI Cycle 1|
1649222|NCT01728454|3033789|Superiority|||||||0.6607|||||||Wilcoxon Rank- Sum Test|||IS: ODI Cycle 1|
1649223|NCT01728454|3033789|Superiority|||||||0.9162|||||||Wilcoxon Rank- Sum Test|||IS: LOCF Cycle 1|
1649224|NCT01728454|3033789|Superiority|||||||0.4814|||||||Wilcoxon Rank- Sum Test|||IS: LOCF Cycle 1|
1649225|NCT01728454|3033789|Superiority|||||||0.0872|||||||Wilcoxon Rank- Sum Test|||PTS: ODI Cycle 1|
1649247|NCT01728454|3033797|Superiority|||||||0.1927|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1|
1649248|NCT01728454|3033797|Superiority|||||||0.1017|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1|
1649249|NCT01728454|3033798|Superiority|||||||0.5375|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1|
1649250|NCT01728454|3033798|Superiority|||||||0.2263|||||||Wilcoxon Rank- Sum Test|||Off-Drug Cycle 1|
1649251|NCT01728454|3033798|Superiority|||||||0.1087|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1|
1649252|NCT01728454|3033798|Superiority|||||||0.036|||||||Wilcoxon Rank- Sum Test|||On-Drug Cycle 1|
1649253|NCT01728376|3033801|Superiority or Other||Difference (%)|-10.0||||||95.0|-60.3|40.3|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms|
1649254|NCT01728376|3033801|Superiority or Other||Difference (%)|37.9|||||2-Sided|95.0|0.7|75.1|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms|
1649255|NCT01728376|3033801|Superiority or Other||Difference (%)|5.0|||||2-Sided|95.0|-29.8|39.8|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in success response between treatment arms|
1649256|NCT01728376|3033802|Superiority or Other||Difference (%)|25.7|||||2-Sided|95.0|-21.0|72.4|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved|
1649257|NCT01728376|3033802|Superiority or Other||Difference (%)|16.3|||||2-Sided|95.0|-13.0|45.7|||||Daptomycin minus Comparator 95% CI by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved|
1649258|NCT01728376|3033802|Superiority or Other||Difference (%)|-2.5|||||2-Sided|95.0|-30.3|25.3|||||Daptomycin minus Comparator 95% Confidence Interval (CI) by Wilson score method|Difference in satisfactory response between treatment groups. Satisfactory response = cured + improved|
1649259|NCT01728324|3033811|Superiority or Other||SVR24 Rates difference|-6.9||||0.0447|2-Sided|95.0|-14.8|1.1|||Koch´s method|Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.||Koch’s stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.|
1649260|NCT01728324|3033812|Superiority or Other||SVR4 Rates difference|3.6||||0.1671|2-Sided|95.0|-3.7|10.9|||Koch´s method|Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.||Koch’s stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.|
1649261|NCT01728324|3033813|Superiority or Other||SVR12 Rates difference|6.4||||0.0532|2-Sided|95.0|-1.4|14.2|||Koch’s method|Adjusted for PegIFN eligibility using Koch’s method, with continuity correction.||Koch’s stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.|
1649262|NCT01728324|3033814|Superiority or Other||Adjusted response rate|75.89||||0.002|2-Sided|95.0|70.63|81.14|||z-test|A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.||The proportion of patients achieving SVR12 achieved with 16 weeks of treatment of non-cirrhotic and 24 weeks of treatment of cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.|
1649263|NCT01728324|3033814|Superiority or Other||Adjusted response rate|81.1|||<|0.0001|2-Sided|95.0|76.34|85.87|||z-test|A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.|The adjusted response rate was tested against the historical control SVR rate of 68% (95% Confidence Interval (CI): 76.3, 85.9).|The proportion of patients achieving SVR12 achieved with 24 weeks of treatment with DBV/FDV/RBV in cirrhotic and non-cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.|
1649264|NCT01728246|3033817|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1649265|NCT01728246|3033819|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1649266|NCT01728246|3033820|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1649267|NCT01727726|3033872|Other||Mean Difference (Final Values)|0.33||||0.123|2-Sided|95.0|-0.09|0.75|||MMRM|Mixed-model repeated measures (MMRM)||Family Life Score|
1649268|NCT01727726|3033872|Other||Mean Difference (Final Values)|-0.35||||0.0424|2-Sided|95.0|-0.69|-0.01|||MMRM|Mixed-model repeated measures (MMRM)||Family Life Score|
1649269|NCT01727726|3033872|Other||Mean Difference (Final Values)|0.43||||0.035|2-Sided|95.0|0.03|0.84|||MMRM|Mixed-model repeated measures (MMRM)||Social Life Score|
1649270|NCT01727726|3033872|Other||Mean Difference (Final Values)|-0.34||||0.0436|2-Sided|95.0|-0.66|-0.01|||MMRM|Mixed-model repeated measures (MMRM)||Social Life Score|
1649271|NCT01727726|3033872|Other||Mean Difference (Final Values)|0.52||||0.038|2-Sided|95.0|0.03|1.02|||MMRM|Mixed-model repeated measures (MMRM)||Work/School Score|
1649272|NCT01727726|3033872|Other||Mean Difference (Final Values)|0.16||||0.448|2-Sided|95.0|-0.25|0.56|||MMRM|Mixed-model repeated measures (MMRM)||Work/School Score|
1649273|NCT01727726|3033874|Other||Ratio of Response Rate|1.24||||0.0898|2-Sided|95.0|0.98|1.59|||Cochran-Mantel-Haenszel|||Phase B Week 6|
1649274|NCT01727726|3033874|Other||Ratio of Response Rate|1.35||||0.0032|2-Sided|95.0|1.1|1.66|||Cochran-Mantel-Haenszel|||Phase B Week 6|
1649275|NCT01727726|3033875|Other||Ratio of Response Rate|0.51||||0.3917|2-Sided|95.0|0.11|2.46|||Cochran-Mantel-Haenszel|||Phase B Week 6|
1649276|NCT01727726|3033875|Other||Ratio of Response Rate|1.52||||0.3321|2-Sided|95.0|0.66|3.49|||Cochran-Mantel-Haenszel|||Phase B Week 6|
1649277|NCT01727726|3033876|Other||Ratio of Response Rate|1.26||||0.5998|2-Sided|95.0|0.53|2.98|||Cochran-Mantel-Haenszel|||Phase B Week 6|
1649278|NCT01727726|3033876|Other||Ratio of response rate|1.49||||0.2242|2-Sided|95.0|0.78|2.84|||Cochran-Mantel-Haenszel|||Phase B Week 6|
1649279|NCT01727726|3033877|Other||Mean Difference (Final Values)|-0.04||||0.7127|2-Sided|95.0|-0.23|0.15|||Cochran-Mantel-Haenszel|||CGI-Improvement Scale Score|
1649280|NCT01727726|3033877|Other||Mean Difference (Final Values)|-0.19||||0.0146|2-Sided|95.0|-0.35|-0.04|||Cochran-Mantel-Haenszel|||CGI-Improvement Scale Score|
1649281|NCT01727726|3033877|Other||Mean Difference (Final Values)|-0.05||||0.5601|2-Sided|95.0|-0.22|0.12|||Cochran-Mantel-Haenszel|||CGI-Severity of Illness Scale Score|
1649282|NCT01727726|3033877|Other||Mean Difference (Final Values)|-0.15||||0.035|2-Sided|95.0|-0.29|-0.01|||Cochran-Mantel-Haenszel|||CGI-Severity of Illness Scale Score|
1649283|NCT01727726|3033878|Other||Mean Difference (Final Values)|-0.08||||0.8949|2-Sided|95.0|-1.27|1.11|||MMRM|Mixed-model repeated measures (MMRM)||Phase B Week 4|
1649284|NCT01727726|3033878|Other||Mean Difference (Final Values)|-1.17||||0.0185|2-Sided|95.0|-2.15|-0.2|||MMRM|Mixed-model repeated measures (MMRM)||Phase B week 4|
1649285|NCT01727726|3033878|Other||Mean Difference (Final Values)|-1.22||||0.0103|2-Sided|95.0|-2.15|-0.29|||MMRM|Mixed-model repeated measures (MMRM)||Phase B Week 2|
1649286|NCT01727726|3033878|Other||Mean Difference (Final Values)|-1.53||||0.0001|2-Sided|95.0|-2.29|-0.76|||MMRM|Mixed-model repeated measures (MMRM)||Phase B week 2|
1649287|NCT01727726|3033879|Other||Mean Difference (Final Values)|0.42||||0.0237|2-Sided|95.0|0.06|0.78|||MMRM|Mixed-model repeated measures (MMRM)|||
1649288|NCT01727726|3033879|Other||Mean Difference (Final Values)|-0.23||||0.1334|2-Sided|95.0|-0.52|0.07|||MMRM|Mixed-model repeated measures (MMRM)|||
1649289|NCT01727726|3033880|Other||Mean Difference (Final Values)|-0.3||||0.6642|2-Sided|95.0|-1.63|1.04|||Cochran-Mantel-Haenszel|Mixed-model repeated measures (MMRM)|||
1649290|NCT01727726|3033880|Other||Mean Difference (Final Values)|-1.48||||0.0078|2-Sided|95.0|-2.56|-0.39|||Cochran-Mantel-Haenszel|Mixed-model repeated measures (MMRM)|||
1649291|NCT01727700|3033902|Superiority or Other||Hazard Ratio (HR)|5.51||||0.0278||||||Hazard ratio < 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.|Regression, Cox||||
1649292|NCT01727700|3033902|Superiority or Other||Discontinuation ratio|4.06||||0.0132|2-Sided|95.0|1.1|14.95||Discontinuation ratio < 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel||||
1649293|NCT01727700|3033902|Superiority or Other||Hazard Ratio (HR)|1.05||||0.9576||||||Hazard ratio < 1 favors aripiprazole. P-value derived from Cox proportional hazard regression adjusting for region and weight group.|Regression, Cox||||
1649294|NCT01727700|3033902|Superiority or Other||Discontinuation ratio|1.16||||0.9187|2-Sided|95.0|0.19|7.05||Discontinuation ratio < 1 favors aripiprazole. P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel||||
1649295|NCT01727700|3033903|Superiority or Other||Response ratio|1.61||||0.0014|2-Sided|95.0|1.2|2.16||P-value derived from CMH General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|Response ratio > 1 favors aripiprazole.|||
1649296|NCT01727700|3033903|Superiority or Other||Response ratio|1.36||||0.0835|2-Sided|95.0|0.98|1.88||P-value derived from Cochran-Mantel-Haenszel (CMH) General Association Test adjusting for region and weight group.|Cochran-Mantel-Haenszel|Response ratio > 1 favors aripiprazole.|||
1649297|NCT01727700|3033904|Superiority or Other||MMRM|-0.92||||0.0002|2-Sided|95.0|-1.41|-0.44||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis||||
1649298|NCT01727700|3033904|Superiority or Other||Treatment difference|-0.8||||0.001|2-Sided|95.0|-1.27|-0.33||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis||||
1649299|NCT01727700|3033905|Superiority or Other||Treatment difference|-19.37|||<|0.0001|2-Sided|95.0|-27.7|-11.04||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis||||
1649300|NCT01727700|3033905|Superiority or Other||Treatment difference|-13.26|||<|0.0017|2-Sided|95.0|-21.43|-5.08||Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|Mixed Models Analysis||||
1649301|NCT01727700|3033906|Superiority or Other||Treatment difference|-1.02||||0.0002|2-Sided|95.0|-1.54|-0.49||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|||
1649302|NCT01727700|3033906|Superiority or Other||Treatment difference|-1.03||||0.0001|2-Sided|95.0|-1.54|-0.52||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.|||
1649303|NCT01727700|3033907|Superiority or Other||Treatment difference|-9.85|||<|0.0001|2-Sided|95.0|-13.84|-5.86||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard SD of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.|
1649304|NCT01727700|3033907|Superiority or Other||Treatment difference|-6.26|||<|0.002|2-Sided|95.0|-10.18|-2.34||The Hochberg procedure was used to adjust for multiplicity.|Mixed Models Analysis|Treatment, week, treatment by week interaction, region, and weight group were fixed categorical effects; baseline value as a fixed covariate.||Assuming 5% of participants may drop out of the trial without a postbaseline efficacy evaluation, a total of 126 participants were required to provide at least 80% power to detect a treatment difference of -5 (common standard deviation [SD] of 8.5) between at least 1 of 2 aripiprazole dose levels and placebo in the primary outcome.|
1649305|NCT01727505|3033908|Superiority or Other|||||||0.006|||||||Paired t-test||||
1649306|NCT01727505|3033909|Superiority or Other|||||||0.049|||||||Wilcoxon signed rank test||||
1649307|NCT01727505|3033910|Superiority or Other|||||||0.02|||||||Wilcoxon signed rank test||||
1649308|NCT01727505|3033911|Superiority or Other|||||||0.2|||||||Wilcoxon signed rank test||||
1649309|NCT01727505|3033912|Superiority or Other|||||||0.75|||||||Wilcoxon signed rank test||||
1649310|NCT01727505|3033913|Superiority or Other|||||||0.44|||||||Wilcoxon signed rank test||||
1649852|NCT01713946|3035413|Superiority||Hazard Ratio (HR)|1.2|||||2-Sided|95.0|0.74|1.96|||||||
1649311|NCT01727414|3033914|Superiority|General linear mixed models were used to evaluate the subtype*dose interaction to determine if the subtypes have unique MPH dose-response curves, with the outcome being ADHD total symptom scores|Slope|0.29|||<|0.05|2-Sided||||||Mixed Models Analysis||||
1649312|NCT01727297|3033916|Superiority||Hazard Ratio (HR)|0.89||||0.63|2-Sided|95.0|0.56|1.43||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having vascular disease on a patient's risk of developing AF.|The null hypothesis was that vascular disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).|
1649313|NCT01727297|3033916|Superiority||Hazard Ratio (HR)|1.97||||0.16|2-Sided|95.0|0.76|5.14||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having a family history of AF on a patient's risk of developing AF.|The null hypothesis was that family history of AF did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).|
1649314|NCT01727297|3033916|Superiority||Hazard Ratio (HR)|0.72||||0.19|2-Sided|95.0|0.45|1.17||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having sleep apnea on a patient's risk of developing AF.|The null hypothesis was that sleep apnea did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).|
1649315|NCT01727297|3033916|Superiority||Hazard Ratio (HR)|0.78||||0.21|2-Sided|95.0|0.53|1.15||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having coronary artery disease on a patient's risk of developing AF.|The null hypothesis was that coronary artery disease did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).|
1649316|NCT01727297|3033916|Superiority||Hazard Ratio (HR)|0.86||||0.53|2-Sided|95.0|0.54|1.38||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having a prior stroke (more than one year pre-device implant) on a patient's risk of developing AF.|The null hypothesis was that prior stroke more than one year pre-device implant did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).|
1649317|NCT01727297|3033916|Superiority||Hazard Ratio (HR)|0.73||||0.22|2-Sided|95.0|0.45|1.2||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having COPD on a patient's risk of developing AF.|The null hypothesis was that Chronic obstructive pulmonary disease (COPD) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).|
1649318|NCT01727297|3033916|Superiority||Hazard Ratio (HR)|0.92||||0.65|2-Sided|95.0|0.64|1.32||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having renal impairment on a patient's risk of developing AF.|The null hypothesis was that renal impairment did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).|
1649319|NCT01727297|3033916|Superiority||Hazard Ratio (HR)|1.23||||0.58|2-Sided|95.0|0.58|2.6||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having hypertension on a patient's risk of developing AF.|The null hypothesis was that hypertension did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).|
1649320|NCT01727297|3033916|Superiority||Hazard Ratio (HR)|1.08||||0.73|2-Sided|95.0|0.69|1.69||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having heart failure on a patient's risk of developing AF.|The null hypothesis was that heart failure did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).|
1649321|NCT01727297|3033916|Superiority||Hazard Ratio (HR)|1.09||||0.66|2-Sided|95.0|0.74|1.59||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of having diabetes on a patient's risk of developing AF.|The null hypothesis was that diabetes did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).|
1649322|NCT01727297|3033916|Superiority||Hazard Ratio (HR)|1.11||||0.56|2-Sided|95.0|0.77|1.61||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons.|Regression, Cox||The hazard ratio represented the effect of being male on a patient's risk of developing AF.|The null hypothesis was that gender did not influence a patient's risk of experiencing AF (it's coefficient for being male in a Cox proportional hazards model was 0).|
1649323|NCT01727297|3033916|Superiority||Hazard Ratio (HR)|1.04||||0.02|2-Sided|95.0|1.01|1.08||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. BMI was treated as a continuous variable.|Regression, Cox||The hazard ratio represented the effect of a one unit increase in BMI on a patient's risk of developing AF. Descriptive statistics (mean ± standard deviation) for BMI were 31.0 ± 6.6 among patients with AF, and 31.2 ± 6.4 among patients without AF|The null hypothesis was that body mass index (BMI) did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).|
1649338|NCT01727258|3033922|Superiority or Other||Mean Difference (Final Values)|0.18|Standard Error of the Mean|1.183|<|0.881|2-Sided|95.0|-2.16|2.52||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649324|NCT01727297|3033916|Superiority||Hazard Ratio (HR)|1.08|||<|0.001|2-Sided|95.0|1.05|1.11||All predictors were tested in a multivariable Cox proportional hazards regression model; the results were not adjusted for multiple comparisons. Age was treated as a continuous variable in years.|Regression, Cox||The hazard ratio represented the effect of a one year increase in age on a patient's risk of developing AF. Descriptive statistics (mean±standard deviation) for age were 75.7±7.9 years among patients with AF, and 69.4±10.0 among patients without AF|The null hypothesis was that age did not influence a patient's risk of experiencing AF (it's coefficient in a Cox proportional hazards model was 0).|
1649325|NCT01727258|3033918|Superiority or Other||Mean Difference (Final Values)|-17.47|Standard Error of the Mean|3.566|<|0.001|2-Sided|95.0|-24.52|-10.42||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649326|NCT01727258|3033918|Superiority or Other||Mean Difference (Final Values)|5.54|Standard Error of the Mean|3.534|<|0.119|2-Sided|95.0|-1.44|12.53||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649327|NCT01727258|3033918|Superiority or Other||Mean Difference (Final Values)|-11.93|Standard Error of the Mean|3.543|<|0.001|2-Sided|95.0|-18.93|-4.93||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649328|NCT01727258|3033919|Superiority or Other||Mean Difference (Final Values)|-12.52|Standard Error of the Mean|3.172|<|0.001|2-Sided|95.0|-18.79|-6.25||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649329|NCT01727258|3033919|Superiority or Other||Mean Difference (Final Values)|4.26|Standard Error of the Mean|3.16|<|0.179|2-Sided|95.0|-1.98|10.51||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649330|NCT01727258|3033919|Superiority or Other||Mean Difference (Final Values)|-8.26|Standard Error of the Mean|3.163|<|0.01|2-Sided|95.0|-14.51|-2.0||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649331|NCT01727258|3033920|Superiority or Other||Mean Difference (Final Values)|-11.98|Standard Error of the Mean|3.313|<|0.001|2-Sided|95.0|-18.53|-5.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649332|NCT01727258|3033920|Superiority or Other||Mean Difference (Final Values)|5.06|Standard Error of the Mean|3.317|<|0.13|2-Sided|95.0|-1.5|11.61||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649333|NCT01727258|3033920|Superiority or Other||Mean Difference (Final Values)|-6.92|Standard Error of the Mean|3.327|<|0.039|2-Sided|95.0|-13.5|-0.35||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649334|NCT01727258|3033921|Superiority or Other||Mean Difference (Final Values)|-6.85|Standard Error of the Mean|2.845||0.017|2-Sided|95.0|-12.47|-1.23||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649335|NCT01727258|3033921|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|2.86||0.964|2-Sided|95.0|-5.52|5.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649336|NCT01727258|3033921|Superiority or Other||Mean Difference (Final Values)|-6.72|Standard Error of the Mean|2.866||0.02|2-Sided|95.0|-12.38|-1.05||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649337|NCT01727258|3033922|Superiority or Other||Mean Difference (Final Values)|5.91|Standard Error of the Mean|1.182|<|0.001|2-Sided|95.0|3.57|8.24||Significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649356|NCT01726049|3033997|Superiority or Other||Mean Difference (Final Values)|0.2|||||2-Sided|95.0|-0.9|1.4|||||||
1649357|NCT01726049|3033998|Superiority or Other||Mean Difference (Final Values)|-4.7|||||2-Sided|95.0|-7.1|-2.3|||||||
1649339|NCT01727258|3033922|Superiority or Other||Mean Difference (Final Values)|6.08|Standard Error of the Mean|1.177|<|0.001|2-Sided|95.0|3.76|8.41||If Potassium Oxalate Mouthrinse is better than Colgate Regular (p<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Sensodyne. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649340|NCT01727258|3033923|Superiority or Other||Mean Difference (Final Values)|12.6|Standard Error of the Mean|1.735|<|0.001|2-Sided|95.0|9.17|16.03||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649341|NCT01727258|3033923|Superiority or Other||Mean Difference (Final Values)|-1.74|Standard Error of the Mean|1.729|<|0.314|2-Sided|95.0|-5.16|1.67||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649342|NCT01727258|3033923|Superiority or Other||Mean Difference (Final Values)|10.85|Standard Error of the Mean|1.72|<|0.001|2-Sided|95.0|7.45|14.25||If Potassium Oxalate Mouthrinse is better than Colgate Regular (p<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouthrinse and Colgate Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1649343|NCT01727024|3033947|Superiority or Other|||||||0.451|||||||Generalized Estimating Equation (GEE)||||
1649344|NCT01726673|3033956|Equivalence|Statistical analysis of median change from baseline to week 36 (6 month FU) was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|187.5||||0.837|2-Sided|||||The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 6 month FU across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test||||
1649345|NCT01726673|3033956|Equivalence|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|270.5||||0.68|2-Sided|||||The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test||||
1649346|NCT01726673|3033957|Equivalence|Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|208.5||||0.592|2-Sided|||||The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 36 weeks ( 6 month follow-up) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test||||
1649347|NCT01726673|3033957|Equivalence|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U Value|251.5||||1|2-Sided|||||The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U Test||||
1649348|NCT01726673|3033958|Equivalence|Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with upper extremity fugl meyer score for the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|222.0||||0.222|2-Sided|||||The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 36 weeks (follow-up) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test||||
1649349|NCT01726673|3033958|Equivalence|Statistical analysis of median change from baseline to DC immediately following 12 weeks of training was assessed with the upper extremity fugl meyer score in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in upper extremity fugl meyer score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed).|U value|302.0||||0.256|2-Sided|||||The Mann-Whitney U test was performed to compare median change in upper extremity fugl meyer score from baseline to 12 weeks (discharge) across two separate study conditions (active vs. sham tDCS).|Mann-Whitney U test||||
1649350|NCT01726504|3033974|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||During the 8-week treatment period, the adjusted change from baseline in mean weekly CSBMs was 1.72 ± 0.12 (95% CI, 1.48 to 1.96) in the EA group and 0.82 ± 0.13 (95% CI, 0.58 to 1.07, P<0.001) times more than that in the SA group.|
1649351|NCT01726049|3033995|Superiority or Other||Mean Difference (Final Values)|-3.5|||||2-Sided|95.0|-5.2|-1.8|||||||
1649352|NCT01726049|3033995|Superiority or Other||Mean Difference (Final Values)|-0.5|||||2-Sided|95.0|-1.9|1.0|||||||
1649353|NCT01726049|3033996|Superiority or Other||Mean Difference (Final Values)|-0.2|||||2-Sided|95.0|-0.5|0.1|||||||
1649354|NCT01726049|3033996|Superiority or Other||Mean Difference (Final Values)|-0.4|||||2-Sided|95.0|-0.9|0.1|||||||
1649355|NCT01726049|3033997|Superiority or Other||Mean Difference (Final Values)|0.7|||||2-Sided|95.0|-0.3|1.6|||||||
1649358|NCT01726049|3033998|Superiority or Other||Mean Difference (Final Values)|-2.4|||||2-Sided|95.0|-4.5|-0.3|||||||
1649359|NCT01726036|3033999|Superiority or Other|||||||0.457|||||||Wilcoxon (Mann-Whitney)||||
1649360|NCT01726023|3034007|Superiority or Other||Difference in median time (days)|1.0||||0.598|||||||Log Rank||||
1649361|NCT01726023|3034008|Superiority or Other||Difference in median time (days)|0.5||||0.773|||||||Log Rank||||
1649362|NCT01726023|3034041|Non-Inferiority or Equivalence|The non-inferiority would be concluded if the lower limit of the 95% confidence interval (CI; corresponding to a 97.5% 1 sided lower bound) was greater than -12.5% for the primary outcome variable.|Risk Difference (RD)|-0.2|||<|0.001|2-Sided|95.0|-5.53|4.97||P-value for 1-sided test at test of cure (TOC) with a -12.5% non-inferiority margin, i.e. H0: diff ≤ -12.5%.|% Risk Difference (RD)|RD is CAZ AVI clinical cure rate minus Meropenem clinical cure rate. The CI was calculated by Miettinen and Nurminen method without adjustment.|units for RD are %|The Primary objective of this study was to assess the non inferiority (based on a 12.5% margin) of CAZ AVI plus metronidazole compared to meropenem alone with respect to clinical cure at the TOC visit in patients who were CE.|
1649363|NCT01725386|3034079|Superiority or Other|||||||0.895|||||||Log Rank (Mantel-Cox)||||
1649364|NCT01725308|3034121|Superiority or Other||Least squares mean difference|-1.7||||0.033|2-Sided|95.0|-3.3|-0.1|||ANCOVA|||At End of Treatment Period I/Week 8: An analysis of covariance (ANCOVA) using a model where the total HAM-D17 score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/II) are fixed effects.|
1649365|NCT01725308|3034128|Superiority or Other||Least squares mean difference|-2.4||||0.034|2-Sided|95.0|-4.7|-0.2|||ANCOVA|||An analysis of covariance (ANCOVA) using a model where the total MADRS score at baseline is a covariate and the treatment group and bipolar disorder diagnosis (Type I/ II) are fixed effects.|
1649366|NCT01725282|3034134|Superiority or Other||Adjusted mean difference|1.3|Standard Error of the Mean|1.7|||2-Sided|95.0|-2.1|4.6|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.||
1649367|NCT01725282|3034134|Superiority or Other||Adjusted mean difference|-0.6|Standard Error of the Mean|1.7|||2-Sided|95.0|-4.0|2.8|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.||
1649368|NCT01725282|3034134|Superiority or Other||Adjusted mean difference|0.2|Standard Error of the Mean|1.7|||2-Sided|95.0|-3.1|3.6|||||An analysis of covariance model with the baseline as a covariate and treatment group as a fixed effect.||
1649369|NCT01725126|3034146|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|0.662|||||2-Sided|90.0|0.578|0.757|||||The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day 1) and confidence interval.|Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.|
1649370|NCT01725126|3034147|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|0.675|||||2-Sided|90.0|0.585|0.779|||||The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day 1) and confidence interval.|Comparison of Day 42 to Day 1 in GSK2890457 treated participants in the PK Population.|
1649371|NCT01725126|3034149|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|1.0334|||||2-Sided|90.0|0.781|1.3673|||||The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day -1) and confidence interval.|Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.|
1649372|NCT01725126|3034150|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|1.046|||||2-Sided|90.0|0.729|1.5008|||||The difference in least squares means and corresponding confidence interval were back-transformed to form ratio of geometric least squares means (Day 42/ Day -1) and confidence interval.|Comparison of Day 42 to Day -1 in GSK2890457+Liraglutide treated participants in the Liraglutide PK Population.|
1649373|NCT01725126|3034154|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.219|||||2-Sided|95.0|-0.91|0.472|||||Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in HbA1c.|
1649374|NCT01725126|3034154|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.065|||||2-Sided|95.0|-0.495|0.365|||||Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in HbA1c.|
1649375|NCT01725126|3034156|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.524|||||2-Sided|95.0|-1.939|0.892|||||Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in fasting glucose.|
1649376|NCT01725126|3034156|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.155|||||2-Sided|95.0|-1.277|1.587|||||Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B -Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in fasting glucose.|
1649377|NCT01725126|3034157|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-1.219|||||2-Sided|95.0|-2.447|0.009|||||Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.|
1649378|NCT01725126|3034157|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.853|||||2-Sided|95.0|-2.232|0.526|||||Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.|
1649504|NCT01721044|3034603|Superiority or Other (legacy)|||||||0.003||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, US Algorithm|
1649379|NCT01725126|3034157|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.356|||||2-Sided|95.0|-1.409|0.698|||||Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-24 hour) weighted mean glucose.|
1649380|NCT01725126|3034157|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|-0.182|||||2-Sided|95.0|-1.694|1.331|||||Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in AUC (0-4 hour) weighted mean glucose.|
1649381|NCT01725126|3034158|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|1.26|||||2-Sided|95.0|-0.24|2.75|||||Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 percent change from Baseline in body weight.|
1649382|NCT01725126|3034158|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.11|||||2-Sided|95.0|-1.64|1.87|||||Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 percent change from Baseline in body weight.|
1649383|NCT01725126|3034159|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|1.08|||||2-Sided|95.0|-0.2|2.36|||||Point estimate was calculated as difference in least squares means: Part C-GSK2890457+Metformin minus Part C-Placebo+Metformin.|Part C-Placebo+Metformin versus Part C-GSK2890457+Metformin for Day 42 change from Baseline in body weight.|
1649384|NCT01725126|3034159|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Mean Difference (Final Values)|0.19|||||2-Sided|95.0|-1.38|1.75|||||Point estimate was calculated as difference in least squares means: Part B-GSK2890457+Liraglutide minus Part B-Placebo+Liraglutide.|Part B-Placebo+Liraglutide versus Part B-GSK2890457+Liraglutide for Day 42 change from Baseline in body weight.|
1649385|NCT01724528|3034206|Superiority or Other||Relative risk|0.994||||1|2-Sided|95.0|0.9691|1.0199|||Chi-squared||||
1649386|NCT01724528|3034207|Superiority or Other||Relative risk|0.875||||0.8488|2-Sided|95.0|0.4408|1.7369|||Chi-squared||||
1649387|NCT01724528|3034208|Superiority or Other||Risk Difference (RD)|0.0231||||0.1993|2-Sided|95.0|-0.0153|0.0654|||Wilson's confidence interval||||
1649388|NCT01724528|3034209|Superiority or Other||Least squares means difference|4.097||||0.0903|2-Sided|95.0|-0.6467|8.8406|||ANCOVA|||Treatment, TLS risk (intermediate/high) and sUA level at baseline (≤ 7.5 mg/dL and > 7.5 mg/dL) were inserted in the ANCOVA model as covariates|
1649389|NCT01724528|3034210|Superiority or Other||Least squares means difference|-196.794|||<|0.0001|2-Sided|95.0|-238.6|-154.988|||ANCOVA|||Treatment, TLS risk (intermediate/high) and sUA level at baseline (≤ 7.5 mg/dL and > 7.5 mg/dL) were inserted in the ANCOVA model as covariates|
1649390|NCT01724177|3034229|Superiority or Other||||||<|0.0001||||||"A one sample binomial one sided exact test for the ORR (CR, CRu, or PR) was performed to provide the p-value (significance level: 0.05). The hypotheses of interest:~H0: ORR ≤ 5% versus H1: ORR > 5%"|Exact Test||||
1649391|NCT01723696|3034265|Superiority||Mean Difference (Final Values)|12.1||||0.19|2-Sided|95.0|-6.1|30.3||P-value adjusted for design factors of site, gestational age at randomization and covariates of length, race, and sex of infant.|ANCOVA|||Our targeted sample size of 218 infants with successful FEFs at 3 months of age was determined to detect with 90% power, at a significance level of 0.05, increases of 15% in mean FEF75 in the vitamin C group compared to the placebo group.|
1649392|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-54.32||||0.11|2-Sided|95.0|-82.58|19.75|||Repeated Measures ANCOVA|||Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649393|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-68.58||||0.02|2-Sided|95.0|-88.02|-17.63|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649394|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|43.1||||0.47|2-Sided|95.0|-47.06|286.83|||Repeated Measures ANCOVA|||Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649395|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-84.39|||<|0.001|2-Sided|95.0|-93.12|-64.6|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649396|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-81.97|||<|0.001|2-Sided|95.0|-92.35|-57.46|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649439|NCT01722331|3034318|Other||Difference in least squares means|-7.4|||<|0.001|2-Sided|95.0|-8.3|-6.5|||Constrained Longitudinal Data Analysis|Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).|||
1649505|NCT01721044|3034603|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, US Algorithm|
1649397|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-83.66|||<|0.001|2-Sided|95.0|-92.79|-62.95|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649398|NCT01723514|3034266|Superiority||LS Geometric Mean Rratio|-79.81|||<|0.001|2-Sided|95.0|-91.44|-52.37|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649399|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-87.6|||<|0.001|2-Sided|95.0|-94.53|-71.88|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649400|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-80.02|||<|0.001|2-Sided|95.0|-91.53|-52.87|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649401|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|13.33|||<|0.73|2-Sided|95.0|-44.39|130.94|||Repeated Measures ANCOVA|||Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649402|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-40.53|||<|0.091|2-Sided|95.0|-67.5|8.82|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649403|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|3.44|||<|0.9|2-Sided|95.0|-40.78|80.66|||Repeated Measures ANCOVA|||Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649404|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-32.7|||<|0.25|2-Sided|95.0|-65.71|32.1|||Repeated Measures ANCOVA|||Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649405|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-79.04|||<|0.001|2-Sided|95.0|-88.02|-63.34|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649406|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-81.06|||<|0.001|2-Sided|95.0|-88.62|-68.49|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649407|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-68.51|||<|0.001|2-Sided|95.0|-81.01|-47.78|||Repeated Measures ANCOVA|||Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649408|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-71.88|||<|0.001|2-Sided|95.0|-83.93|-50.82|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649409|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-73.03|||<|0.001|2-Sided|95.0|-83.79|-55.11|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649410|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-72.34|||<|0.001|2-Sided|95.0|-83.32|-54.13|||Repeated Measures ANCOVA|||Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649466|NCT01721447|3034418|Superiority||||||<|0.001|||||||Chi-squared||||
1649467|NCT01721447|3034419|Superiority||||||<|0.001|||||||Chi-squared||||
1649411|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-79.52|||<|0.001|2-Sided|95.0|-88.29|-64.17|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649412|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-71.16|||<|0.001|2-Sided|95.0|-82.67|-52.0|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649413|NCT01723514|3034266|Superiority||LS Geometric Mean Ratio|-79.33|||<|0.001|2-Sided|95.0|-87.54|-65.73|||Repeated Measures ANCOVA|||Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .|
1649414|NCT01723397|3034274|Superiority or Other|||||||0.8|||||||Wilcoxon signed-rank test||||
1649415|NCT01723228|3034283|Superiority or Other||Least Squares Mean Difference|-2.3||||0.0003|2-Sided|95.0|-3.53|-1.08|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.|||
1649416|NCT01723228|3034284|Superiority or Other||Least Squares Mean Difference|-2.5||||0.0151|2-Sided|95.0|-4.47|-0.49|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.|||
1649417|NCT01723228|3034285|Superiority or Other|||||||0.3331|||||||Cochran-Mantel-Haenszel|For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC Functional Abilities|
1649418|NCT01723228|3034285|Superiority or Other||Odds Ratio (OR)|1.39||||0.3204|2-Sided|95.0|0.72|2.68|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Functional Abilities|
1649419|NCT01723228|3034285|Superiority or Other|||||||0.6639|||||||Cochran-Mantel-Haenszel|For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC Behavior|
1649420|NCT01723228|3034285|Superiority or Other||Odds Ratio (OR)|1.16||||0.6909|2-Sided|95.0|0.56|2.43|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Behavior|
1649421|NCT01723228|3034285|Superiority or Other|||||||0.9945||||||For the CMH p-value, the statistical model is a CMH test controlling for center with scores=modridit option.|Cochran-Mantel-Haenszel|||CGIC Cognition|
1649422|NCT01723228|3034285|Superiority or Other||Odds Ratio (OR)|0.96||||0.8857|2-Sided|95.0|0.52|1.75|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC Cognition|
1649423|NCT01723228|3034285|Superiority or Other|||||||0.1052|||||||Cochran-Mantel-Haenszel|For the Cochran-Mantel-Haenszel (CMH) p-value, the statistical model is a CMH test controlling for center with scores=modridit option.||CGIC|
1649424|NCT01723228|3034285|Superiority or Other||Odds Ratio (OR)|1.61||||0.1148|2-Sided|95.0|0.89|2.93|||Proportional Odds Model|The statistical model is a proportional odds model with terms for treatment, center, and age.||CGIC|
1649425|NCT01723228|3034286|Superiority or Other||Least Squares Mean Difference|-0.7||||0.4796|2-Sided|95.0|-2.74|1.3|||ANCOVA|The statistical model is an analysis of covariance (ANCOVA) with treatment, center, baseline score, and age as fixed effects.|||
1649426|NCT01723228|3034287|Superiority or Other||Least Squares Mean Difference|-0.1||||0.8428|2-Sided|95.0|-0.99|0.81|||Repeated Measures Model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.|||
1649427|NCT01723228|3034288|Superiority or Other||Least Squares Mean Difference|0.8||||0.2204|2-Sided|95.0|-0.48|2.05|||repeated measures model|The statistical model is a repeated measures model with visit by treatment interaction, center, baseline score, and age as fixed effects.|||
1649428|NCT01722929|3034295|Other||||||<|0.0001||||||p-value is for the main effect for the Treatment, Time, and Treatment*Time interaction.|Mixed Models Analysis|||A mixed ANOVA was performed with the arms as a between factor and the three times as the within factor.|
1649429|NCT01722552|3034303|Equivalence|The margin for non-equivalence was 25 percentage points.|Risk Ratio (RR)|1.59|||<|0.05|2-Sided|95.0|1.21|2.1|||Chi-squared|||The primary analysis was by intent to treat (ITT). This included data for all randomized subjects, with post-intervention adherence measured by the last 30 days of available data; adherence over the entire 6-month intervention period was measured using all available post-intervention data. Our sample size was designed to detect a 25 percentage point difference in proportion achieving optimal adherence post-intervention.|
1649430|NCT01722487|3034305|Superiority or Other|||||||0.0054|||||||Chi-squared||||
1649431|NCT01722487|3034306|Superiority or Other|||||||0.0009|||||||Chi-squared||||
1649432|NCT01722487|3034307|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1649433|NCT01722487|3034308|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1649434|NCT01722487|3034309|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1649435|NCT01722487|3034310|Superiority or Other||Hazard Ratio (HR)|0.16||||0.001|2-Sided|95.0|0.05|0.56|||Log Rank||||
1649436|NCT01722487|3034311|Superiority or Other||Hazard Ratio (HR)|0.16|||<|0.0001|2-Sided|95.0|0.09|0.28|||Log Rank||||
1649437|NCT01722331|3034317|Other||Difference in percentages|36.1|||<|0.001|2-Sided|95.0|29.3|42.5|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|||
1649438|NCT01722331|3034317|Other||Difference in percentages|38.9|||<|0.001|2-Sided|95.0|31.9|45.4|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|||
1649440|NCT01722331|3034318|Other||Difference in least squares means|-7.7|||<|0.001|2-Sided|95.0|-8.6|-6.8|||Constrained Longitudinal Data Analysis|Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).|||
1649441|NCT01722331|3034320|Superiority||Difference in percentages|12.7|||<|0.001|2-Sided|95.0|8.0|17.3|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|||
1649442|NCT01722331|3034320|Superiority||Difference in percentages|12.7|||<|0.001|2-Sided|95.0|8.3|17.2|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|||
1649443|NCT01722331|3034321|Superiority||Difference in percentages|32.1|||<|0.001|2-Sided|95.0|25.9|38.0|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|||
1649444|NCT01722331|3034321|Superiority||Difference in percentages|32.9|||<|0.001|2-Sided|95.0|26.8|38.8|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|||
1649445|NCT01722331|3034328|Superiority||Difference in percentages|50.9|||<|0.001|2-Sided|95.0|43.6|57.4|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|||
1649446|NCT01722331|3034328|Superiority||Difference in percentages|52.1|||<|0.001|2-Sided|95.0|44.8|58.5|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|||
1649447|NCT01722331|3034329|Superiority||Difference in percentages|58.0|||<|0.001|2-Sided|95.0|51.0|64.1|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|||
1649448|NCT01722331|3034329|Superiority||Difference in percentages|56.6|||<|0.001|2-Sided|95.0|49.6|62.8|||Cochran-Mantel-Haenszel|Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.|||
1649449|NCT01722071|3034362|Superiority or Other|||||||0.814||||||The a priori threshold for statistical significance was p<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens [Bilateral]). For the group of 10 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.|
1649450|NCT01722071|3034362|Superiority or Other|||||||0.422||||||The a priori threshold for statistical significance was p<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens [Bilateral]). For the group of 8 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.|
1649451|NCT01722071|3034362|Superiority or Other|||||||0.89||||||The a priori threshold for statistical significance was p<0.05.|t-test, 2 sided|||A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens [Bilateral]). For the group of 18 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.|
1649452|NCT01721954|3034376|Superiority||Hazard Ratio (HR)|0.75|||<|0.05|2-Sided||||||Log Rank|||A sample size of at least 209 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 14.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 209. The Null hypothesis is no difference between the treatment arms with respect to PFS.|
1649453|NCT01721954|3034377|Superiority||Hazard Ratio (HR)|0.93||||0.43|2-Sided|95.0|||||Log Rank|||The null hypothesis tested for the primary efficacy endpoint is overall survival (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is OS time for SIRT/FOLFOX treatment lower to that of FOLFOX.|
1649454|NCT01721772|3034382|Superiority or Other (legacy)||Unstratified Hazard Ratio|0.56|||||2-Sided|95.0|0.37|0.85|||||PD-L1 negative group||
1649455|NCT01721772|3034382|Superiority or Other (legacy)||Unstratified Hazard Ratio|0.16|||||2-Sided|95.0|0.07|0.38|||||PD-L1 positive group||
1649456|NCT01721772|3034383|Superiority or Other (legacy)||Odds Ratio (OR)|4.06|||<|0.0001|2-Sided|95.0|2.52|6.54|||Cochran-Mantel-Haenszel||||
1649457|NCT01721772|3034385|Superiority or Other (legacy)||Hazard Ratio (HR)|0.43|||<|0.0001|2-Sided|95.0|0.34|0.56|||Stratified Log Rank Test||||
1649458|NCT01721772|3034386|Superiority or Other (legacy)||Hazard Ratio (HR)|0.42|||<|0.0001|2-Sided|95.0|0.3|0.6|||Stratified Log Rank Test||||
1649459|NCT01721746|3034391|Other||Odds Ratio (OR)|0.55|||||2-Sided|95.0|0.35|0.87|||||from unstratified Cox proportional hazard model using randomized arm as single covariate.|For >=5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice|
1649460|NCT01721746|3034391|Other||Hazard Ratio, log|1.22|||||2-Sided|95.0|0.85|1.74|||||From unstratified Cox proportional hazard model using randomized arm as single covariate.|For <5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice|
1649461|NCT01721746|3034392|Other||Odds Ratio (OR)|5.49|||||2-Sided|95.0|1.92|19.08||||||For >=5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice|
1649462|NCT01721746|3034392|Other||Odds Ratio (OR)|1.13|||||2-Sided|95.0|0.44|3.16||||||For <5% PD-L1 expression. Ratio of Nivolumab over Investigator's Choice|
1649463|NCT01721746|3034393|Other||Hazard Ratio (HR)|1.03|||||2-Sided|95.1|0.78|1.36|||||Hazard Ratio is Nivolumab 3 mg/kg (IV) over Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|Stratified Cox proportional hazard model.|
1649464|NCT01721746|3034394|Other||Hazard Ratio (HR)|0.95||||0.7164|2-Sided|95.54|0.73|1.24|||Log Rank|Log-rank Test stratified by BRAF status, prior anti-CTLA-4 benefit, and PD-L1 status (Interactive Voice Response System (IVRS) source).||Nivolumab 3 mg/kg (IV) vs Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|
1649465|NCT01721746|3034395|Other||Difference of Objective Response Rate|17.4|||||2-Sided|95.0|9.5|24.3|||||Nivolumab vs Investigator's Choice.|Unweighted ORR difference with 95% CI.|
1649468|NCT01721408|3034420|Non-Inferiority or Equivalence|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-6.0||||0.004|2-Sided|95.0|-12.8|0.8|||See method of CI||Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.||
1649469|NCT01721408|3034422|Non-Inferiority or Equivalence|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in eradication rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-7.3||||0.0277|2-Sided|95.0|-15.2|0.5|||See method of CI||CIs and p-values for between-group treatment difference in eradication rates were calculated by the asymptotic method corrected for continuity with normal distribution approximation.||
1649470|NCT01721408|3034423|Non-Inferiority or Equivalence|Non-inferiority was concluded if the lower limit of the 2-sided CI for the difference in cure rates between treatment groups (tigecycline minus imipenem/cilastatin) was greater than -15%.|Difference in percentage|-7.3||||0.0277|2-Sided|95.0|-15.2|0.5|||See method of CI||CIs and p-values for between-group treatment difference in cure rate were calculated by the asymptotic method corrected for continuity with normal distribution approximation.||
1649471|NCT01721408|3034424|Non-Inferiority or Equivalence|Assuming that the 2 treatments were equally effective, with cure rates of 75 % at the TOC assessment, the study was powered to ensure with 90% probability that the lower limit of a 2-sided 95% confidence interval (CI) for the true difference (tigecycline minus imipenem/cilastatin) in cure rates was greater than -15%.|Difference in percentage|-6.7||||0.0008|2-Sided|95.0|-12.0|-1.4|||See method of CI||Used the asymptotic method corrected for continuity with normal distribution approximation. Non-inferiority test was conducted on the CE population. If non-inferiority was concluded, superiority test was conducted on both the CE and mITT populations.||
1649472|NCT01721161|3034471|Superiority or Other||Difference|-7.55||||0.0504|2-Sided|95.0|-15.12|0.01|||ANCOVA||||
1649473|NCT01721161|3034472|Superiority or Other||DIfference|-0.8||||0.8015|2-Sided|95.0|-6.7|5.2|||ANCOVA|||LCLA 2.5%|
1649474|NCT01721161|3034472|Superiority or Other||Difference|-1.2||||0.6645|2-Sided|95.0|-6.6|4.3|||ANCOVA|||LCLA 1.25% chart|
1649475|NCT01721161|3034473|Superiority or Other||Difference|-0.8||||0.7741|2-Sided|95.0|-6.5|4.9|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|LCLA 2.5% chart|
1649476|NCT01721161|3034473|Superiority or Other||Difference|-1.6||||0.5371|2-Sided|95.0|-6.9|3.6|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.|LCLA 1.25% chart|
1649477|NCT01721161|3034474|Superiority or Other||Difference|-1.76||||0.3505|2-Sided|95.0|-5.5|1.98|||ANCOVA||||
1649478|NCT01721161|3034475|Superiority or Other||Difference|-1.15||||0.4975|2-Sided|95.0|-4.51|2.21|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.||
1649479|NCT01721161|3034476|Superiority or Other||Difference|-4.76||||0.1488|2-Sided|95.0|-11.26|1.74|||ANCOVA||||
1649480|NCT01721161|3034477|Superiority or Other||Difference|-3.89||||0.1868|2-Sided|95.0|-9.7|1.92|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.||
1649481|NCT01721161|3034478|Superiority or Other||Difference|-3.48||||0.3337|2-Sided|95.0|-10.61|3.65|||ANCOVA||Difference is calculated as BIIB033 100 mg/kg - placebo.||
1649482|NCT01721109|3034488|Equivalence|A sample size of 14 participants was estimated to provide over 95% power to show pharmacokinetic equivalence between adult and adolescent participants. EVG population PK from historical adult data was used for comparison. The inter-subject standard deviation (natural log scale) of EVG AUCtau observed in the population PK data was 0.31 (historical data).|Geometric least squares mean ratio|1.3029|||||2-Sided|90.0|1.0479|1.62|||||||
1649483|NCT01721057|3034599|Superiority or Other (legacy)|||||||0.001|||||||Regression, Logistic||||
1649484|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.03|||||||ANCOVA|||Activity Impairment Week 24|
1649485|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.001|||||||ANCOVA|||Activity Impairment Week 24|
1649486|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.005|||||||ANCOVA|||Activity Impairment Week 12|
1649487|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.001|||||||ANCOVA|||Activity Impairment Week 12|
1649488|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.479|||||||ANCOVA|||Work Productivity Loss Week 24|
1649489|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.327|||||||ANCOVA|||Work Productivity Loss Week 24|
1649490|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.07|||||||ANCOVA|||Work Productivity Loss Week 12|
1649491|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.079|||||||ANCOVA|||Work Productivity Loss Week 12|
1649492|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.534|||||||ANCOVA|||Presenteeism Week 24|
1649493|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.232|||||||ANCOVA|||Presenteeism Week 24|
1649494|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.058|||||||ANCOVA|||Presenteeism Week 12|
1649495|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.077|||||||ANCOVA|||Presenteeism Week 12|
1649496|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.715|||||||ANCOVA|||Absenteeism Week 24|
1649497|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.753|||||||ANCOVA|||Absenteeism Week 24|
1649498|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.17|||||||ANCOVA|||Absenteeism Week 12|
1649499|NCT01721044|3034602|Superiority or Other (legacy)|||||||0.362|||||||ANCOVA|||Absenteeism Week 12|
1649500|NCT01721044|3034603|Superiority or Other (legacy)|||||||0.002||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, UK Algorithm|
1649501|NCT01721044|3034603|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24, UK Algorithm|
1649502|NCT01721044|3034603|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, UK Algorithm|
1649503|NCT01721044|3034603|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, UK Algorithm|
1649506|NCT01721044|3034603|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, US Algorithm|
1649507|NCT01721044|3034603|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12, US Algorithm|
1649508|NCT01721044|3034604|Superiority or Other (legacy)|||||||0.001|||||||ANCOVA|||PCS Week 24|
1649509|NCT01721044|3034604|Superiority or Other (legacy)|||||||0.001|||||||ANCOVA|||PCS Week 24|
1649510|NCT01721044|3034604|Superiority or Other (legacy)|||||||0.001|||||||ANCOVA|||PCS Week 12|
1649511|NCT01721044|3034604|Superiority or Other (legacy)|||||||0.001|||||||ANCOVA|||PCS Week 12|
1649512|NCT01721044|3034604|Superiority or Other (legacy)|||||||0.401|||||||ANCOVA|||MCS Week 24|
1649513|NCT01721044|3034604|Superiority or Other (legacy)|||||||0.446|||||||ANCOVA|||MCS Week 24|
1649514|NCT01721044|3034604|Superiority or Other (legacy)|||||||0.058|||||||ANCOVA|||MCS Week 12|
1649515|NCT01721044|3034604|Superiority or Other (legacy)|||||||0.448|||||||ANCOVA|||MCS Week 12|
1649516|NCT01721044|3034605|Superiority or Other (legacy)|||||||0.026||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24|
1649517|NCT01721044|3034605|Superiority or Other (legacy)|||||||0.002||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 24|
1649518|NCT01721044|3034605|Superiority or Other (legacy)|||||||0.004||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12|
1649519|NCT01721044|3034605|Superiority or Other (legacy)|||||||0.005||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA|||Week 12|
1649520|NCT01721044|3034606|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA||||
1649521|NCT01721044|3034606|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA||||
1649522|NCT01721044|3034607|Superiority or Other (legacy)|||||||0.018||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA||||
1649523|NCT01721044|3034607|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA||||
1649524|NCT01721044|3034608|Superiority or Other (legacy)|||||||0.004||||||a priori p-value significance threshold: 2-sided ≤0.05|Wilcoxon (Mann-Whitney)||||
1649525|NCT01721044|3034608|Superiority or Other (legacy)|||||||0.002||||||a priori p-value significance threshold: 2-sided ≤0.05|Wilcoxon (Mann-Whitney)||||
1649526|NCT01721044|3034609|Superiority or Other (legacy)|||||||0.104||||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.|||
1649527|NCT01721044|3034609|Superiority or Other (legacy)|||||||0.012||||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.|||
1649528|NCT01721044|3034610|Superiority or Other (legacy)|||||||0.003||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA||||
1649529|NCT01721044|3034610|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA||||
1649530|NCT01721044|3034611|Superiority or Other (legacy)|||||||0.009||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA||||
1649531|NCT01721044|3034611|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA||||
1649532|NCT01721044|3034612|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA||||
1649533|NCT01721044|3034612|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|ANCOVA||||
1649534|NCT01721044|3034613|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24|
1649535|NCT01721044|3034613|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24|
1649536|NCT01721044|3034613|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12|
1649537|NCT01721044|3034613|Superiority or Other (legacy)|||||||0.002||||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12|
1649538|NCT01721044|3034614|Superiority or Other (legacy)|||||||0.015||||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24|
1649539|NCT01721044|3034614|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 24|
1649540|NCT01721044|3034614|Superiority or Other (legacy)|||||||0.002||||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12|
1649541|NCT01721044|3034614|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided ≤0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.||Week 12|
1649542|NCT01721044|3034615|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided <=0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.|||
1649543|NCT01721044|3034615|Superiority or Other (legacy)|||||||0.001||||||a priori p-value significance threshold: 2-sided <=0.05|Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.|||
1649707|NCT01718483|3034825|Superiority or Other||||||<|0.001||||||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Cochran-Mantel-Haenszel||||
1649544|NCT01721044|3034616|Superiority or Other (legacy)|||||||0.723|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.|||
1649545|NCT01721044|3034617|Superiority or Other (legacy)|||||||0.001|||||||ANCOVA||||
1649546|NCT01721044|3034618|Superiority or Other (legacy)|||||||0.001|||||||ANCOVA||||
1649547|NCT01721044|3034619|Superiority or Other (legacy)|||||||0.001|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.|||
1649548|NCT01721044|3034620|Superiority or Other (legacy)|||||||0.14|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.|||
1649549|NCT01721044|3034621|Superiority or Other (legacy)|||||||0.001|||||||ANCOVA||||
1649550|NCT01721044|3034622|Superiority or Other (legacy)|||||||0.001|||||||ANCOVA||||
1649551|NCT01721044|3034623|Superiority or Other (legacy)|||||||0.001|||||||Regression, Logistic|If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.|||
1649552|NCT01720667|3034633|Superiority||||||<|0.001|||||||Fisher Exact|||Comparison of seizure cessation at 48 hours using Fisher's exact test|
1649553|NCT01720667|3034634|Superiority||||||<|0.001|||||||Fisher Exact|||Comparison of 24 hour seizure termination rates using a Fisher's exact test.|
1649554|NCT01720524|3034651|Superiority||LS Mean Difference|79.9||||0.1576|2-Sided|95.0|-32.5|192.2|||ANCOVA|||Hour 24|
1649555|NCT01720524|3034651|Superiority||LS Mean Difference|26.6||||0.1802|2-Sided|95.0|-12.7|65.9|||ANCOVA|||Hour 12|
1649556|NCT01720524|3034651|Superiority||LS Mean Difference|37.2||||0.0829|2-Sided|95.0|-5.0|79.5|||ANCOVA|||Hour 6|
1649557|NCT01720524|3034652|Superiority||LS Mean Difference|-8.2||||0.2089|2-Sided|95.0|-21.2|4.8|||ANCOVA|||Hour 24|
1649558|NCT01720524|3034652|Superiority||LS Mean Difference|-8.0||||0.1112|2-Sided|95.0|-17.8|1.9|||ANCOVA|||Hour 12|
1649559|NCT01720524|3034652|Superiority||LS Mean Difference|0.7||||0.7686|2-Sided|95.0|-4.3|5.8|||ANCOVA|||Hour 6|
1649560|NCT01720524|3034653|Superiority||LS Mean Difference|-2.2||||0.4249|2-Sided|95.0|-7.6|3.3|||ANCOVA|||Hour 24|
1649561|NCT01720524|3034653|Superiority||LS Mean Difference|4.1||||0.3956|2-Sided|95.0|-5.5|13.7|||ANCOVA|||Hour 12|
1649562|NCT01720524|3034653|Superiority||LS Mean Difference|3.9||||0.4984|2-Sided|95.0|-7.5|15.3|||ANCOVA|||Hour 6|
1649563|NCT01720524|3034654|Superiority||Difference in Percentage|6.9||||0.2373|2-Sided|95.0|-5.5|22.8|||Fisher Exact|||Death|
1649564|NCT01720524|3034654|Superiority||Difference in Percentage|0.3|||>|0.999|2-Sided|95.0|-18.5|18.5|||Fisher Exact|||ECMO|
1649565|NCT01720524|3034654|Superiority||Difference in Percentage|3.8|||>|0.7065|2-Sided|95.0|-15.2|22.9|||Fisher Exact|||Additional Treatment|
1649566|NCT01720524|3034655|Superiority|||||||0.491|||||||Log Rank||||
1649567|NCT01720524|3034656|Superiority|||||||0.9885|||||||Log Rank||||
1649568|NCT01720524|3034657|Superiority||Difference in percentage|7.6||||0.4935|2-Sided|95.0|-14.1|29.3|||Chi-squared||||
1649569|NCT01720524|3034658|Superiority||Least square (LS) mean difference|0.0|Standard Error of the Mean|1.02||0.985|2-Sided|95.0|-2.08|2.04|||ANCOVA||||
1649570|NCT01720446|3034659|Superiority or Other||Treatment difference|2.47|||<|0.0001|2-Sided|95.0|1.52|3.43|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649571|NCT01720446|3034659|Superiority or Other||Treatment difference|2.02|||<|0.0001|2-Sided|95.0|1.07|2.98|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for pulse rate was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649572|NCT01720446|3034660|Superiority or Other||Treatment ratio|0.92||||0.0003|2-Sided|95.0|0.88|0.96|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649573|NCT01720446|3034660|Superiority or Other||Treatment ratio|0.99||||0.7796|2-Sided|95.0|0.95|1.04|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for free fatty acids was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649574|NCT01720446|3034661|Superiority or Other||Treatment difference|1.2||||0.0064|2-Sided|95.0|0.34|2.07|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649575|NCT01720446|3034661|Superiority or Other||Treatment difference|0.33||||0.4523|2-Sided|95.0|-0.53|1.19|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for vitality was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649576|NCT01720446|3034661|Superiority or Other||Treatment difference|1.14||||0.0237|2-Sided|95.0|0.15|2.13|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649577|NCT01720446|3034661|Superiority or Other||Treatment difference|-0.05||||0.9223|2-Sided|95.0|-1.03|0.93|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for social functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649578|NCT01720446|3034661|Superiority or Other||Treatment difference|1.14||||0.0197|2-Sided|95.0|0.18|2.11|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649579|NCT01720446|3034661|Superiority or Other||Treatment difference|0.72||||0.1431|2-Sided|95.0|-0.24|1.67|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for role physical was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649580|NCT01720446|3034661|Superiority or Other||Treatment difference|0.94||||0.1136|2-Sided|95.0|-0.22|2.1|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649581|NCT01720446|3034661|Superiority or Other||Treatment difference|0.53||||0.3717|2-Sided|95.0|-0.63|1.68|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for role emotional was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649582|NCT01720446|3034661|Superiority or Other||Treatment difference|1.5||||0.0011|2-Sided|95.0|0.6|2.4|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649583|NCT01720446|3034661|Superiority or Other||Treatment difference|0.8||||0.0799|2-Sided|95.0|-0.1|1.69|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for physical functioning was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649584|NCT01720446|3034661|Superiority or Other||Treatment difference|1.4||||0.0004|2-Sided|95.0|0.62|2.17|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649585|NCT01720446|3034661|Superiority or Other||Treatment difference|0.68||||0.0833|2-Sided|95.0|-0.09|1.45|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for physical component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649586|NCT01720446|3034661|Superiority or Other||Treatment difference|1.39||||0.0029|2-Sided|95.0|0.48|2.31|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649587|NCT01720446|3034661|Superiority or Other||Treatment Difference|0.61||||0.186|2-Sided|95.0|-0.3|1.53|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for mental health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649588|NCT01720446|3034661|Superiority or Other||Treatment difference|0.97||||0.0489|2-Sided|95.0|0.0|1.94|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649589|NCT01720446|3034661|Superiority or Other||Treatment difference|0.17||||0.7277|2-Sided|95.0|-0.79|1.13|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for mental component summary was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649590|NCT01720446|3034661|Superiority or Other||Treatment difference|1.42||||0.0007|2-Sided|95.0|0.6|2.24|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649591|NCT01720446|3034661|Superiority or Other||Treatment difference|0.87||||0.035|2-Sided|95.0|0.06|1.69|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for general health was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649592|NCT01720446|3034661|Superiority or Other||Treatment difference|1.47||||0.0031|2-Sided|95.0|0.5|2.45|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649593|NCT01720446|3034661|Superiority or Other||Treatment difference|0.5||||0.3171|2-Sided|95.0|-0.48|1.47|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for bodily pain was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649594|NCT01720446|3034665|Superiority or Other||Treatment difference|-2.59||||0.0008|2-Sided|95.0|-4.09|-1.08|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649595|NCT01720446|3034665|Superiority or Other||Treatment difference|-1.27||||0.0976|2-Sided|95.0|-2.77|0.23|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for systolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649596|NCT01720446|3034665|Superiority or Other||Treatment difference|0.14||||0.7477|2-Sided|95.0|-0.74|1.03|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo 1.0 mg|Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649597|NCT01720446|3034665|Superiority or Other||Treatment difference|0.04||||0.9205|2-Sided|95.0|-0.83|0.92|||Mixed Models Analysis||Semaglutide 0.5 mg - Placebo 0.5 mg|Analysis for diastolic blood pressure was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649598|NCT01720446|3034666|Superiority or Other||Treatment ratio|0.71|||<|0.0001|2-Sided|95.0|0.62|0.81|||Mixed Models Analysis||Sema 1.0 mg / Placebo 1.0 mg|Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649599|NCT01720446|3034666|Superiority or Other||Treatment ratio|0.78|||<|0.0003|2-Sided|95.0|0.68|0.89|||Mixed Models Analysis||Sema 0.5 mg / Placebo 0.5 mg|Analysis for urinary albumin to creatinine ration was donne using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.|
1649600|NCT01720446|3034667|Superiority or Other||Treatment ratio|0.93||||0.0009|2-Sided|95.0|0.89|0.97|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649601|NCT01720446|3034667|Superiority or Other||Treatment ratio|0.97||||0.1833|2-Sided|95.0|0.93|1.01|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for triglycerides was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649602|NCT01720446|3034667|Superiority or Other||Treatment ratio|0.99||||0.5996|2-Sided|95.0|0.96|1.03|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649603|NCT01720446|3034667|Superiority or Other||Treatment ratio|0.96||||0.0185|2-Sided|95.0|0.93|0.99|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for LDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649604|NCT01720446|3034667|Superiority or Other||Treatment ratio|1.04|||<|0.0001|2-Sided|95.0|1.02|1.06|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649605|NCT01720446|3034667|Superiority or Other||Treatment ratio|1.0|||<|0.8106|2-Sided|95.0|0.99|1.02|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for HDL-cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649606|NCT01720446|3034667|Superiority or Other||Treatment ratio|0.99|||<|0.258|2-Sided|95.0|0.97|1.01|||Mixed Models Analysis||Semaglutide 1.0 mg/Placebo 1.0 mg|Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.|
1649607|NCT01720446|3034667|Superiority or Other||Treatment ratio|0.97|||<|0.0149|2-Sided|95.0|0.95|1.0|||Mixed Models Analysis||Semaglutide 0.5 mg/Placebo 0.5 mg|Analysis for total cholesterol was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit. The response and its baseline value were log-transformed before analysis.|
1649608|NCT01720446|3034668|Superiority or Other||Treatment difference|-4.27|||<|0.0001|2-Sided|95.0|-4.78|-3.75|||Mixed Models Analysis||Semaglutide 1.0 mg - Placebo|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649609|NCT01720446|3034668|Superiority or Other||Treatment difference|-2.95|||<|0.0001|2-Sided|95.0|-3.47|-2.44|||Mixed Models Analysis||Sema 0.5 mg - Placebo|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649610|NCT01720446|3034669|Superiority or Other||Treatment difference|-1.22|||<|0.0001|2-Sided|95.0|-1.56|-0.88|||Mixed Models Analysis||Sema 1.0 mg - Placebo 1.0 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649611|NCT01720446|3034669|Superiority or Other||Treatment difference|-0.72|||<|0.0001|2-Sided|95.0|-1.06|-0.38|||Mixed Models Analysis||Sema 0.5 mg - Placebo 0.5 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649612|NCT01720446|3034670|Superiority or Other||Treatment difference|-1.05|||<|0.0001|2-Sided|95.0|-1.19|-0.91|||Mixed Models Analysis||Sema 1.0 mg - Placebo 1.0 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649613|NCT01720446|3034670|Superiority or Other||Treatment difference|-0.66|||<|0.0001|2-Sided|95.0|-0.8|-0.52|||Mixed Models Analysis||Sema 0.5 mg - Placebo 0.5 mg|Analysis was done using a mixed model for repeated measurements with treatment (4 levels) and stratification (9 levels) as fixed factors and baseline value as covariate, all nested within visit.|
1649614|NCT01720446|3034671|Superiority or Other||Hazard Ratio (HR)|0.77||||0.0292|2-Sided|95.0|0.61|0.97|||Regression, Cox||Semaglutide/Placebo|Analysis for all-cause death, non-fatal MI or non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).|
1649615|NCT01720446|3034672|Superiority or Other||Hazard Ratio (HR)|1.11||||0.5735|2-Sided|95.0|0.77|1.61|||Regression, Cox||Semaglutide/Placcbo|Analysis for hospitalisation for heart failure was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).|
1649708|NCT01718483|3034826|Superiority or Other||Least squares mean difference|-0.02||||0.308|2-Sided|95.0|-0.07|0.02|||ANCOVA||||
1649709|NCT01718483|3034827|Superiority or Other||Least squares mean difference|-0.211|||<|0.001|2-Sided|95.0|-0.33|-0.092|||ANCOVA||||
1649616|NCT01720446|3034672|Superiority or Other||Hazard Ratio (HR)|0.82||||0.4914|2-Sided|95.0|0.47|1.44|||Regression, Cox||Semaglutide/Placebo|Analysis for 'unstable angina requiring hospitalisation' was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).|
1649617|NCT01720446|3034672|Superiority or Other||Hazard Ratio (HR)|0.65||||0.0027|2-Sided|95.0|0.5|0.86|||Regression, Cox||Semaglutide/Placebo|Analysis for revascularisation was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).|
1649618|NCT01720446|3034672|Superiority or Other||Hazard Ratio (HR)|0.61||||0.0438|2-Sided|95.0|0.38|0.99|||Regression, Cox||Semaglutide/Placebo|Analysis for non-fatal stroke was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).|
1649619|NCT01720446|3034672|Superiority or Other||Hazard Ratio (HR)|0.74||||0.1194|2-Sided|95.0|0.51|1.08|||Regression, Cox||Semaglutide/Placebo|Analysis for non-fatal myocardial infarction was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).|
1649620|NCT01720446|3034672|Superiority or Other||Hazard Ratio (HR)|0.98||||0.9181|2-Sided|95.0|0.65|1.48|||Regression, Cox||Semaglutide/Placebo|Analysis for CV death was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).|
1649621|NCT01720446|3034673|Superiority or Other||Hazard Ratio (HR)|0.74||||0.0016|2-Sided|95.0|0.62|0.89|||Regression, Cox||Semaglutide/Placebo|Analysis was done by Cox proportional hazards model with treatment (semaglutide; placebo) as a fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).|
1649622|NCT01720446|3034674|Superiority or Other||Hazard Ratio (HR)|0.74||||0.0167|2-Sided|95.0|0.58|0.95||The 'p-value' is for the two-sided Wald test of no difference.|Regression, Cox||Semaglutide/Placebo|A post hoc analysis of superiority of semaglutide versus placebo was performed based on the pre-specified Cox proportional hazard analysis using the two-sided Wald test of no difference, with treatment (semaglutide, placebo) as fixed factor and stratified by all possible combinations of the three stratification factors used in the randomisation procedure (in total 9 levels).|
1649623|NCT01720446|3034674|Non-Inferiority or Equivalence|Non-inferiority of semaglutide versus placebo was considered to be confirmed if the upper limit of the two-sided 95% CI for the HR was below 1.8 or equivalent if the p-value for the one-sided test of: H0: HR ≥ 1.8 against Ha: HR <1.8 was less than 2.5% (or equivalent to 5% for a two-sided test).|Hazard Ratio (HR)|0.74|||<|0.0001|2-Sided|95.0|0.58|0.95||The 'p-value' is for the two-sided Wald test of non-inferiority with limit 1.8.|Regression, Cox||Semaglutide/Placebo|The primary endpoint was analysed using a stratified Cox proportional hazards model with treatment group (semaglutide, placebo) as fixed factor. Assuming the same population MACE risk for the semaglutide and placebo groups (i.e., the population hazards ratio [HR] equals 1), a total minimum of 122 events were needed in order to have at least 90% power to ascertain that the upper two-sided 95% confidence limit for the HR was less than 1.8.|
1649624|NCT01720069|3034711|Superiority|||||||0.805|||||||Fisher Exact||||
1649625|NCT01720069|3034711|Superiority|||||||0.363|||||||Fisher Exact||||
1649626|NCT01720069|3034711|Superiority|||||||0.168|||||||Fisher Exact||||
1649627|NCT01720069|3034712|Superiority|||||||0.054|||||||ANCOVA||||
1649628|NCT01720069|3034713|Superiority|||||||0.063|||||||ANCOVA||||
1649629|NCT01720069|3034714|Superiority|||||||0.066|||||||ANCOVA||||
1649630|NCT01720069|3034715|Superiority|||||||0.891|||||||ANCOVA||||
1649631|NCT01720069|3034716|Superiority|||||||0.772|||||||ANCOVA||||
1649632|NCT01720043|3034717|Superiority|||||||0.238|||||||t-test, 2 sided|||Ristocetin.0.5.mg.ml, 48 hrs|
1649633|NCT01720043|3034717|Superiority|||||||0.969|||||||t-test, 2 sided|||Ristochetin.1.5.mg.ml|
1649634|NCT01720043|3034717|Superiority|||||||0.614|||||||t-test, 2 sided|||Arach.Acid.0.5.mg.ml, 48 hrs|
1649635|NCT01720043|3034717|Superiority|||||||0.77|||||||t-test, 2 sided|||ADP.3.M, 48 hrs|
1649636|NCT01720043|3034717|Superiority|||||||0.417|||||||t-test, 2 sided|||ADP.5.M|
1649637|NCT01720043|3034717|Superiority|||||||0.245|||||||t-test, 2 sided|||ADP.10.M|
1649638|NCT01720043|3034717|Superiority|||||||0.838|||||||t-test, 2 sided|||Collagen.2.g.ml, 48 hrs|
1649639|NCT01720043|3034717|Superiority|||||||0.549|||||||t-test, 2 sided|||Collagen.5.g.ml, 48 hrs|
1649640|NCT01720043|3034717|Superiority|||||||0.381|||||||t-test, 2 sided|||Ristocetin.0.5.mg.ml|
1649641|NCT01720043|3034717|Superiority|||||||0.625|||||||t-test, 2 sided|||Ristocetin.1.5.mg.ml|
1649642|NCT01720043|3034717|Superiority|||||||0.106|||||||t-test, 2 sided|||Arach.Acid.0.5.mg.ml|
1649643|NCT01720043|3034717|Superiority|||||||0.268|||||||t-test, 2 sided|||ADP.3.M, 24 hrs|
1649644|NCT01720043|3034717|Superiority|||||||0.066|||||||t-test, 2 sided|||ADP.5.M|
1649645|NCT01720043|3034717|Superiority|||||||0.132|||||||t-test, 2 sided|||ADP.10.M, 24 hrs|
1649646|NCT01720043|3034717|Superiority|||||||0.164|||||||t-test, 2 sided|||Collagen.2.g.ml|
1649647|NCT01720043|3034717|Superiority|||||||0.181|||||||t-test, 2 sided|||Collagen.5.g.ml, 24 hrs|
1649648|NCT01719653|3034757|Other||||||>|0.005|||||||Chi-squared|||All 5 arms were compared pair-wise.|
1649649|NCT01719653|3034758|Other||||||<|0.001||||||1 was lower than 4,5.|t-test, 2 sided|||"All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split"|
1649650|NCT01719653|3034759|Other||||||<|0.005||||||Chicago BPS Total Score -- 1 was lower than 3,4,5; 2 was lower than 5. Modified Chicago BPS Total Score -- 1 were lower than 5. Chicago BPS Fluid Score -- 1 was dryer than 3,4,5; 2 was dryer than 3,4,5; 3 was wetter than 4,5.|t-test, 2 sided|||"All 5 arms were compared pair-wise.~1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split"|
1649651|NCT01719172|3034764|Superiority or Other||Median Difference (Final Values)|1.0|||||1-Sided|95.0||1.0||||||Time to achieve hemostasis was analyzed using the Kaplan–Meier method to estimate the survival distribution and to obtain the estimated median time to hemostasis. Additionally, A 95% Brookmeyer–Crowley confidence interval for the median was computed based on the sign test.|
1649652|NCT01719172|3034765|Superiority or Other|||||||0.0214||||||The p-value from a one-sided exact test was based on the binomial distribution, testing that the true percent success rate was ≤ 50% versus the alternative hypothesis that the success rate was > 50%.|t-test, 1 sided|||The number and percentage of subjects who achieved hemostasis within 1 minute were presented. An exact (Clopper–Pearson) 95% confidence interval for the true percentage was calculated.|
1649653|NCT01719172|3034766|Superiority or Other||||||<|0.0001||||||The p-value from a one-sided exact test was based on the binomial distribution, testing that the true percent success rate was ≤ 50% versus the alternative hypothesis that the success rate was > 50%.|t-test, 1 sided|||The primary effectiveness endpoint was the percent (%) success in obtaining hemostasis at the Target Bleeding Site (TBS) within 5 minutes following Veriset™ application. An exact (Clopper–Pearson) 95% confidence interval for the true success percentage was calculated. Subjects who received rescue therapy on the target bleeding site prior to obtaining hemostasis were considered failures.|
1649654|NCT01719003|3034767|Superiority or Other||Adjusted Mean|-2.26|Standard Error of the Mean|0.42|<|0.0001|2-Sided|95.0|-3.09|-1.43||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.|
1649655|NCT01719003|3034767|Superiority or Other||Adjusted mean|-2.2|Standard Error of the Mean|0.42|<|0.0001|2-Sided|95.0|-3.03|-1.37||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment|
1649656|NCT01719003|3034767|Superiority or Other||Adjusted Mean|-2.52|Standard Error of the Mean|0.42|<|0.0001|2-Sided|95.0|-3.35|-1.69||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.|
1649657|NCT01719003|3034767|Superiority or Other||Adjusted mean|-2.5|Standard Error of the Mean|0.42|<|0.0001|2-Sided|95.0|-3.33|-1.68||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of body weight after 24 weeks of double-blind treatment.|
1649658|NCT01719003|3034768|Superiority or Other||Adjusted mean|-12.6|Standard Error of the Mean|3.4||0.0002|2-Sided|95.0|-19.1|-6.0||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.|
1649659|NCT01719003|3034768|Superiority or Other||Adjusted Mean|-28.2|Standard Error of the Mean|3.4|<|0.0001|2-Sided|95.0|-35.0|-21.5||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.|
1649660|NCT01719003|3034768|Superiority or Other||Adjusted Mean|-14.8|Standard Error of the Mean|3.4|<|0.0001|2-Sided|95.0|-21.4|-8.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.|
1649661|NCT01719003|3034768|Superiority or Other||Adjusted mean|-15.6|Standard Error of the Mean|3.4|<|0.0001|2-Sided|95.0|-22.3|-8.9||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG of double-blind treatment|
1649662|NCT01719003|3034768|Superiority or Other||Adjusted mean|-16.0|Standard Error of the Mean|3.4|<|0.0001|2-Sided|95.0|-22.8|-9.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.|
1649663|NCT01719003|3034768|Superiority or Other||Adjusted Mean|-26.7|Standard Error of the Mean|3.4|<|0.0001|2-Sided|95.0|-33.5|-20.0||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.|
1649664|NCT01719003|3034768|Superiority or Other||Adjusted mean|-23.0|Standard Error of the Mean|3.4|<|0.0001|2-Sided|95.0|-29.7|-16.3||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.|
1649665|NCT01719003|3034768|Superiority or Other||Adjusted mean|-18.8|Standard Error of the Mean|3.4|<|0.0001|2-Sided|95.0|-25.5|-12.2||Since previous step in the hierarchical testing failed (primary measure analyses 9 and 10), the analyses for secondary measures of FPG and body weight are considered exploratory and not confirmatory|Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of FPG after 24 weeks of double-blind treatment.|
1649666|NCT01719003|3034769|Non-Inferiority or Equivalence|The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.|Adjusted mean|0.4|Standard Error of the Mean|0.12||0.6558|2-Sided|95.0|0.16|0.63|||Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 10 mg qd minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.|
1649667|NCT01719003|3034769|Non-Inferiority or Equivalence|The noninferiority of empagliflozin 10 mg qd against metformin 1000 mg bid were to be tested for HbA1c change from baseline to Week 24 at the level of α=0.025 (one-sided), through application of a non-inferiority margin of 0.35%.|Adjusted mean|0.39|Standard Error of the Mean|0.12||0.6246|2-Sided|95.0|0.15|0.62|||Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 25 mg qd minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.|
1649668|NCT01719003|3034769|Superiority or Other||Adjusted mean|-0.63|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.86|-0.4|||Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.|
1649669|NCT01719003|3034769|Superiority or Other||Adjusted Mean|-0.79|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-1.03|-0.56|||Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.|
1649670|NCT01719003|3034769|Superiority or Other||Adjusted Mean|-0.72|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.95|-0.49|||Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Empagliflozin 10 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.|
1649671|NCT01719003|3034769|Superiority or Other||Adjusted mean|-0.33|Standard Error of the Mean|0.12|<|0.0062|2-Sided|95.0|-0.56|-0.09|||Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 5 mg bid + Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment|
1649672|NCT01719003|3034769|Superiority or Other||Adjusted mean|-0.57|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.81|-0.34|||Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.|
1649710|NCT01718483|3034828|Superiority or Other||Least squares mean difference|-0.199|||<|0.001|2-Sided|95.0|-0.31|-0.088|||ANCOVA||||
1649853|NCT01713946|3035413|Superiority||Hazard Ratio (HR)|1.27|||||2-Sided|95.0|0.77|2.07|||||||
1649673|NCT01719003|3034769|Superiority or Other||Adjusted Mean|-0.75|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.98|-0.51|||Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 500 mg bid minus Metformin 500 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.|
1649674|NCT01719003|3034769|Superiority or Other||Adjusted mean|-0.72|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.95|-0.48|||Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Empagliflozin 25 mg qd|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.|
1649675|NCT01719003|3034769|Superiority or Other||Adjusted mean|-0.33|Standard Error of the Mean|0.12|<|0.0056|2-Sided|95.0|-0.56|-0.1|||Mixed Models Analysis|'Baseline HbA1c’:linear covariate;'treatment','baseline renal function','region','visit' & 'visit by treatment interaction':fixed effects.|Empagliflozin 12.5 mg bid+ Metformin 1000 mg bid minus Metformin 1000 mg bid|Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach comparing the change from baseline of HbA1c (in units of %) after 24 weeks of double-blind treatment.|
1649676|NCT01718522|3034784|Other|||||||0.22|||||||Wilcoxon Signed-Rank Test||||
1649677|NCT01718522|3034785|Other|||||||0.1|||||||Wilcoxon Signed-Rank Test||||
1649678|NCT01718522|3034786|Other|||||||0.61|||||||Wilcoxon Signed-Rank Test||||
1649679|NCT01718522|3034787|Other|||||||0.001|||||||Wilcoxon Signed-Rank Test||||
1649680|NCT01718522|3034788|Other|||||||0.35|||||||Wilcoxon Signed-Rank Test||||
1649681|NCT01718522|3034789|Other|||||||0.04|||||||Wilcoxon Signed-Rank Test||||
1649682|NCT01718522|3034790|Other|||||||0.03|||||||t-test, 2 sided||||
1649683|NCT01718522|3034791|Other|||||||0.3|||||||Wilcoxon Signed-Rank Test||||
1649684|NCT01718522|3034792|Other|||||||0.12|||||||Wilcoxon Signed-Rank Test||||
1649685|NCT01718522|3034793|Other|||||||0.001|||||||t-test, 2 sided||||
1649686|NCT01718509|3034801|Superiority or Other||Least Squares Mean Difference|-0.96||||0.298|2-Sided|95.0|-2.77|0.85||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|ANCOVA||||
1649687|NCT01718509|3034802|Superiority or Other||Least Squares Mean Difference|-9.28|||<|0.001|2-Sided|95.0|-11.44|-7.12||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis||||
1649688|NCT01718509|3034803|Superiority or Other||Least Squares Mean Difference|-4.21|||<|0.001|2-Sided|95.0|-5.09|-3.33||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Perceived Hunger|
1649689|NCT01718509|3034803|Superiority or Other||Least Squares Mean Difference|-3.6|||<|0.001|2-Sided|95.0|-4.44|-2.76||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Disinhibition of Eating|
1649690|NCT01718509|3034803|Superiority or Other||Least Squares Mean Difference|1.27|||<|0.011|2-Sided|95.0|0.29|2.24||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Cognitive Restraint of Eating|
1649691|NCT01718509|3034804|Superiority or Other||Least Squares Mean Difference|-2.23|||<|0.001|2-Sided|95.0|-2.77|-1.69||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis||||
1649692|NCT01718509|3034805|Superiority or Other||||||<|0.001||||||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Cochran-Mantel-Haenszel||||
1649693|NCT01718509|3034806|Superiority or Other||Least Squares Mean Difference|0.03||||0.185|2-Sided|95.0|-0.02|0.08|||ANCOVA||||
1649694|NCT01718509|3034807|Superiority or Other||Least Squares Mean Difference|-0.077||||0.234|2-Sided|95.0|-0.205|0.05|||ANCOVA||||
1649695|NCT01718509|3034808|Superiority or Other||Least Squares Mean Difference|-0.196||||0.002|2-Sided|95.0|-0.321|-0.07|||ANCOVA||||
1649696|NCT01718509|3034809|Superiority or Other||Least Squares Mean Difference|-7.94|||<|0.001|2-Sided|95.0|-9.51|-6.36|||Mixed Models Repeated Measures Analysis||||
1649697|NCT01718509|3034810|Superiority or Other||Least Squares Mean Difference|-5.41|||<|0.001|2-Sided|95.0|-6.39|-4.44|||Mixed Models Repeated Measures Analysis||||
1649698|NCT01718509|3034811|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1649699|NCT01718509|3034812|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1649700|NCT01718509|3034813|Superiority or Other||Least Squares Mean Difference|-1.66|||<|0.001|2-Sided|95.0|-2.04|-1.28|||Mixed Models Repeated Measures Analysis||||
1649701|NCT01718483|3034821|Superiority or Other||Least squares mean difference|-0.31||||0.706|2-Sided|95.0|-1.93|1.31||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|ANCOVA||||
1649702|NCT01718483|3034822|Superiority or Other||Least squares mean difference|-10.32|||<|0.001|2-Sided|95.0|-12.43|-8.21||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis||||
1649703|NCT01718483|3034823|Superiority or Other||Least squares mean difference|-4.7|||<|0.001|2-Sided|95.0|-5.49|-3.91||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Perceived Hunger|
1649704|NCT01718483|3034823|Superiority or Other||Least squares mean difference|-4.19|||<|0.001|2-Sided|95.0|-4.98|-3.39||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Disinhibition of Eating|
1649705|NCT01718483|3034823|Superiority or Other||Least squares mean difference|1.65|||<|0.001|2-Sided|95.0|0.72|2.57||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis|||Cognitive Restraint of Eating|
1649706|NCT01718483|3034824|Superiority or Other||Least squares mean difference|-1.77|||<|0.001|2-Sided|95.0|-2.24|-1.3||Multiplicity is not adjusted for this secondary efficacy endpoint in this study.|Mixed Models Repeated Measures Analysis||||
1651052|NCT01690273|3038181|Superiority or Other|||||||1|||||||Mixed Models Analysis||||
1649711|NCT01718483|3034829|Superiority or Other||Least squares mean difference|-7.4|||<|0.001|2-Sided|95.0|-8.93|-5.88|||Mixed Models Repeated Measures Analysis||||
1649712|NCT01718483|3034830|Superiority or Other||Least squares mean difference|-6.35|||<|0.001|2-Sided|95.0|-7.17|-5.54|||Mixed Models Repeated Measures Analysis||||
1649713|NCT01718483|3034831|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1649714|NCT01718483|3034832|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1649715|NCT01718483|3034833|Superiority or Other||Least squares mean difference|-1.35|||<|0.001|2-Sided|95.0|-1.7|-1.01|||Mixed Models Repeated Measures Analysis||||
1649716|NCT01718353|3034834|Other|||||||0.0927|||||||ANOVA|||MTB change from baseline at Cycle 1 Day 8 in participants with ≥30% decrease in PSA at Cycle 4 was compared with that of participants who did not have ≥30% decrease in PSA at Cycle 4|
1649717|NCT01718353|3034842|Other|||||||0.02|||||||ANOVA|||%ARNL change from baseline at Cycle 1 Day 8 in participants with ≥50% decrease in PSA at Cycle 4 was compared with that of participants who did not have ≥50% decrease in PSA at Cycle 4|
1649718|NCT01717872|3034879|Superiority or Other||||||<|0.0004|||||||Wilcoxon (Mann-Whitney)||||
1649719|NCT01717872|3034880|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1649720|NCT01717872|3034881|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||MAC blade lifting the tongue versus Miller blade lifting the epiglottis|
1649721|NCT01717456|3034978|Superiority or Other||Mean Difference (Final Values)|4.0|Standard Deviation|6.72||0.05|2-Sided|95.0||||No adjustment for multiple comparisons.|t-test, 2 sided||||
1649722|NCT01717313|3034997|Superiority or Other||Difference in the least squares means|-20.5||||0.031|2-Sided|95.0|-39.0|-1.9|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status|||
1649723|NCT01717313|3034998|Superiority or Other||Difference in the least squares means|-13.2||||0.014|2-Sided|95.0|-23.7|-2.7|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status|||
1649724|NCT01717313|3034999|Superiority or Other||Difference in the least squares means|-0.53|||<|0.001|2-Sided|95.0|-0.75|-0.32|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status|||
1649725|NCT01717313|3035004|Superiority or Other||Difference in the least squares means|-11.6||||0.177|2-Sided|95.0|-28.6|5.3|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status|||
1649726|NCT01717313|3035005|Superiority or Other||Difference in the least squares means|-10.3||||0.036|2-Sided|95.0|-19.9|-0.7|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status|||
1649727|NCT01717313|3035006|Superiority or Other||Between-group rate difference|11.4||||0.001|2-Sided|95.0|4.8|18.6|||Miettinen & Nurminen method||||
1649728|NCT01717313|3035007|Superiority or Other||Between-group rate difference|20.3|||<|0.001|2-Sided|95.0|10.5|29.8|||Miettinen & Nurminen method||||
1649729|NCT01717313|3035008|Superiority or Other||Difference in percentages vs. placebo|0.6|||||2-Sided|95.0|-3.5|4.8|||||||
1649730|NCT01717313|3035009|Superiority or Other||Difference in percentages vs. placebo|-5.8|||||2-Sided|95.0|-16.4|4.9|||||||
1649731|NCT01717313|3035010|Superiority or Other||Difference in percentages vs. placebo|0.6|||||2-Sided|95.0|-3.1|4.5|||||||
1649732|NCT01717313|3035011|Superiority or Other||Differences in percentages vs. placebo|-8.2|||||2-Sided|95.0|-18.8|2.6|||||||
1649733|NCT01717313|3035012|Superiority or Other||Difference in the least squares means|-0.39|||<|0.001|2-Sided|95.0|-0.59|-0.19|||Constrained Longitudinal Data Analysis|Terms for treatment, time, prior antihyperglycemic agent (AHA) therapy status, interaction of time by treatment, and time by prior AHA therapy status|||
1649734|NCT01716754|3035042|Superiority or Other|||||||0.408|||||||Repeated measures mixed model|||Overall daily|
1649735|NCT01716754|3035042|Superiority or Other|||||||0.762|||||||Repeated measures mixed model|||Overall daily|
1649736|NCT01716754|3035042|Superiority or Other|||||||0.88|||||||Repeated measures mixed model|||Evening|
1649737|NCT01716754|3035042|Superiority or Other|||||||0.937|||||||Repeated measures mixed model|||Evening|
1649738|NCT01716754|3035042|Superiority or Other|||||||0.26|||||||Repeated measures mixed model|||Morning|
1649739|NCT01716754|3035042|Superiority or Other|||||||0.604|||||||Repeated measures mixed model|||Morning|
1649740|NCT01716754|3035044|Superiority or Other||Odds Ratio (OR)|1.39||||0.261|2-Sided|95.0|0.79|2.44|||Regression, Logistic||||
1649741|NCT01716754|3035044|Superiority or Other||Odds Ratio (OR)|1.32||||0.483|2-Sided|95.0|0.61|2.86|||Regression, Logistic||||
1649742|NCT01716754|3035046|Superiority or Other||Odds Ratio (OR)|0.84||||0.556|2-Sided|95.0|0.46|1.52|||Regression, Logistic||||
1649743|NCT01716754|3035046|Superiority or Other||Odds Ratio (OR)|0.79||||0.576|2-Sided|95.0|0.35|1.78|||Regression, Logistic||||
1649744|NCT01716585|3035062|Non-Inferiority or Equivalence|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 84% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|98.0|||||2-Sided|95.0|95.8|100.0|||||95% CI calculated using the normal approximation to the binomial distribution.||
1649745|NCT01716585|3035063|Non-Inferiority or Equivalence|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 75% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|95.7|||||2-Sided|95.0|93.4|97.9|||||95% CI calculated using the normal approximation to the binomial distribution.||
1651053|NCT01690273|3038181|Superiority or Other|||||||0.97|||||||Mixed Models Analysis||||
1649746|NCT01716585|3035064|Superiority or Other||||||<|0.001||||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|Fisher Exact||||
1649747|NCT01716585|3035065|Non-Inferiority or Equivalence|Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects administered telaprevir plus peginterferon (pegIFN)/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 70% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 80% to achieve superiority.|Percentage of Participants with SVR12|96.4|||||2-Sided|95.0|94.7|98.1|||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.|With a sample size of 450 subjects and assuming that 92% of the subjects in Arm A will achieve SVR12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 70% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 80% (based on the normal approximation of a single binomial proportion). 95% CI calculated using the normal approximation to the binomial distribution.|
1649748|NCT01716533|3035081|Superiority|ANOVA model -pooled variance.|GMC ratio|1.65||||0.7124|2-Sided|95.0|0.1|26.41||P-value = two-sided p-value for HO: GMC ratio = 1, groups considered as statistically significant different if the two-sided p-value is below 0.05.|ANOVA||GMC ratio = GMC Sustained response Group /GMC Recurrence Group.|Serum F2 C-terminal anti-toxin B antibody concentrations at Day 14 were compared between the Sustained response Group and Recurrence Group by using a one-way analysis of variance (ANOVA) model on the log-transformed concentration.|
1649749|NCT01716533|3035082|Superiority||GMC ratio|1.53||||0.5746|2-Sided|95.0|0.33|7.14||P-value = two-sided p-value for HO: GMC ratio = 1 (ANOVA model, T-test), groups considered as statistically significant different if the two-sided p-value is below 0.05.|ANOVA|ANOVA model -pooled variance.|GMC ratio = GMC Sustained response Group /GMC Recurrence Group.|ELISA anti-toxin B antibody concentrations at Day 14 were compared between the Sustained response Group and Recurrence Group by using a one-way analysis of variance (ANOVA) model on the log-transformed concentration.|
1649750|NCT01716520|3035086|Superiority or Other||Mean Difference (Final Values)|0.073||||0.006|2-Sided|95.0|0.021|0.124||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of >=12% and 200 mL at any assessment(s).||
1649751|NCT01716520|3035086|Superiority or Other||Mean Difference (Final Values)|0.052||||0.047|2-Sided|95.0|0.001|0.104||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to Neither=responders to neither UMEC nor VI, as defined by a participant with at least one FEV1 assessment over 0-6 hours post-dose on Day 1 but no increase from Baseline of >=12% and 200 mL at any assessment(s).||
1649752|NCT01716520|3035086|Superiority or Other||Mean Difference (Final Values)|0.098|||<|0.001|2-Sided|95.0|0.067|0.13||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of >=12% and 200 mL at >=1 time point over 0-6 hours post-dose in FEV1 on Day 1.||
1649753|NCT01716520|3035086|Superiority or Other||Mean Difference (Final Values)|0.142|||<|0.001|2-Sided|95.0|0.11|0.174||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to VI=responders to VI or to both monotherapies, as defined by a participant with an increase from Baseline of >=12% and 200 mL at >=1 time point over 0-6 hours post-dose in FEV1 on Day 1.||
1649754|NCT01716520|3035086|Superiority or Other||Mean Difference (Final Values)|0.135|||<|0.001|2-Sided|95.0|0.1|0.171||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of >=12% and 200 mL at >=1 time point over 0-6 hours post-dose in FEV1 on Day 1.||
1649755|NCT01716520|3035086|Superiority or Other||Mean Difference (Final Values)|0.121|||<|0.001|2-Sided|95.0|0.085|0.157||Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, period, mean Baseline, period Baseline, response type and treatment by response type interaction.|ANCOVA||Responders to UMEC=responders to UMEC or to both monotherapies, as defined by a participant with an increase from Baseline of >=12% and 200 milliliters (mL) at >=1 time point over 0-6 hours post-dose in FEV1 on Day 1.||
1649756|NCT01716104|3035116|Superiority|||||||0.0142|||||||Mixed Models Analysis||||
1649757|NCT01716104|3035117|Superiority|||||||0.0621|||||||Mixed Models Analysis||||
1649758|NCT01716104|3035118|Superiority|||||||0.0862|||||||Mixed Models Analysis||||
1649759|NCT01716104|3035119|Superiority|||||||0.0437|||||||Mixed Models Analysis||||
1649760|NCT01716104|3035120|Superiority|||||||0.0054|||||||Mixed Models Analysis||||
1649761|NCT01716104|3035121|Superiority|||||||0.0011|||||||Mixed Models Analysis||||
1649762|NCT01716104|3035122|Superiority|||||||0.0008|||||||Mixed Models Analysis||||
1649763|NCT01716104|3035123|Superiority|||||||0.035|||||||Mixed Models Analysis||||
1649764|NCT01716104|3035124|Superiority|||||||0.0005|||||||Mixed Models Analysis||||
1649765|NCT01715896|3035135|Superiority or Other||Adjusted geometric mean ratio|1.05||||0.725|2-Sided|90.0|0.84|1.3|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.||
1649818|NCT01714310|3035370|Superiority|||||||0.9||||||Group: F=.02, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|||
1649766|NCT01715896|3035136|Superiority or Other||Adjusted geometric mean ratio|1.06||||0.752|2-Sided|90.0|0.79|1.41|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis.||
1649767|NCT01715896|3035137|Superiority or Other||Adjusted mean difference|0.18||||0.055|2-Sided|90.0|0.03|0.34|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.||
1649768|NCT01715896|3035138|Superiority or Other||Adjusted mean difference|0.16||||0.64|2-Sided|90.0|-0.42|0.74|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.||
1649769|NCT01715896|3035139|Superiority or Other||Adjusted mean difference|4.46||||0.319|2-Sided|90.0|-2.92|11.84|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.||
1649770|NCT01715896|3035140|Superiority or Other||Adjusted mean difference|4.89||||0.272|2-Sided|90.0|-2.46|12.24|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.||
1649771|NCT01715896|3035141|Superiority or Other||Adjusted mean difference|1.23||||0.424|2-Sided|90.0|-1.31|3.77|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|Analysis reported for change from baseline in Tender joint count at Day 169.|
1649772|NCT01715896|3035141|Superiority or Other||Adjusted mean difference|-0.01||||0.993|2-Sided|90.0|-1.33|1.32|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction.|Analysis reported for change from baseline in swollen joint count at Day 169.|
1649773|NCT01715896|3035142|Superiority or Other||Percent difference|-7.5||||0.061|2-Sided|90.0|-13.6|-1.5|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.||
1649774|NCT01715896|3035143|Superiority or Other||Percent difference|-11.9||||0.035|2-Sided|90.0|-20.6|-3.1|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.||
1649775|NCT01715896|3035144|Superiority or Other||Percent difference|-11.7||||0.048|2-Sided|90.0|-21.0|-2.5|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.||
1649776|NCT01715896|3035145|Superiority or Other||Percent difference|-1.7||||0.795|2-Sided|90.0|-12.4|9.0|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|P-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.|
1649777|NCT01715896|3035146|Superiority or Other|||||||0.003|||||||Weibull model|P-value was calculated using an Weibull model.|||
1649778|NCT01715896|3035147|Superiority or Other|||||||0.328|||||||Log Rank|P-value was calculated using the Log rank test.|||
1649779|NCT01715896|3035148|Superiority or Other||Percent difference|-11.7||||0.145|2-Sided|90.0|-24.8|1.4|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|The analysis reported DAS28 (CRP) low disease activity response.|
1649780|NCT01715896|3035148|Superiority or Other||Percent difference|-11.6||||0.108||90.0|-23.2|0.0|||Regression, Logistic||90% CI was calculated for the treatment difference in proportion of responders using logisitic regression with strata and treatment as factors.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of golimumab or active responders was less than 5.|
1649781|NCT01715896|3035149|Superiority or Other||Odds Ratio (OR)|0.61||||0.129|2-Sided|90.0|0.36|1.04|||Proportional odds analysis||Odds ratio, 90% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor.||
1649782|NCT01715896|3035151|Superiority or Other||Adjusted Mean difference|-7.42||||0.213|2-Sided|90.0|-17.24|2.4|||Repeated measures model||An estimate of the treatment difference and its 90% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term.||
1649783|NCT01715896|3035158|Superiority or Other||Percent difference|-10.3||||0.208|2-Sided|90.0|-23.7|3.0|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.||
1649784|NCT01715896|3035159|Superiority or Other||Percent difference|-11.6||||0.108|2-Sided|90.0|-23.2|0.0|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.||
1649785|NCT01715896|3035160|Superiority or Other||Percent difference|-9.8||||0.156|2-Sided|90.0|-21.1|1.4|||Logit Response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.||
1649786|NCT01715896|3035161|Superiority or Other||Percent difference|-8.6||||0.293|2-Sided|90.0|-22.0|4.8|||Logit response Model||P-value and 90% unconditional exact CI was calculated using the model of logit (response) = strata + treatment.||
1649787|NCT01715896|3035162|Superiority or Other||Percent difference|-3.5||||0.666|2-Sided|90.0|-16.8|9.8|||Logit response Model||P-value and 90% unconditional exact confidence interval (CI) was calculated using the model of logit (response) = strata + treatment.||
1649788|NCT01715805|3035190|Superiority||LSMD|-0.7||||0.2784|2-Sided|95.0|-1.9|0.5||MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Mixed Models Analysis||Cariprazine +ADT - Placebo + ADT||
1649850|NCT01713946|3035412|Superiority||Difference in least square means|1.0|||||2-Sided|95.0|-2.2|4.3|||||||
1649789|NCT01715805|3035191|Superiority||Least Squares Mean Difference (LSMD)|-0.2||||0.7948|2-Sided|95.0|-1.6|1.2||MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Mixed Models Analysis||Cariprazine + ADT - Placebo + ADT||
1649790|NCT01715415|3035195|Non-Inferiority or Equivalence|Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 77% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|96.7|||||2-Sided|95.0|93.6|99.9|||||||
1649791|NCT01715415|3035196|Non-Inferiority or Equivalence|Based on historical SVR rates for noncirrhotic pegIFN/RBV treatment-experienced subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 65% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.|Percentage of Participants with SVR12|96.0|||||2-Sided|95.0|93.0|98.9|||||95% CI calculated using the normal approximation to the binomial distribution.||
1649792|NCT01715415|3035197|Superiority or Other||||||<|0.001||||||In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and the first 3 secondary endpoints in the order numbered below.|Fisher Exact||||
1649793|NCT01715415|3035198|Non-Inferiority or Equivalence|Based on historical SVR rates for noncirrhotic peg-interferon/ribavirin (pegIFN/RBV) treatment-experienced subjects administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 60% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 70% to achieve superiority.|Percentage of Participants with SVR12|96.3|||||2-Sided|95.0|94.1|98.4|||||95% CI calculated using the normal approximation to the binomial distribution. In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and numbered secondary efficacy endpoints.|With a sample size of 300 subjects and assuming that 85% of the subjects in Arm A will achieve sustained virologic response (SVR) 12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 60% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 70% (based on the normal approximation of a single binomial proportion).|
1649794|NCT01715285|3035220|Superiority||Hazard Ratio (HR)|0.661|||<|0.0001|2-Sided|95.0|0.564|0.775|||Log Rank||||
1649795|NCT01715285|3035221|Superiority||Hazard Ratio (HR)|0.466|||<|0.0001|2-Sided|95.0|0.394|0.55|||Log Rank||||
1649796|NCT01714817|3035304|Superiority or Other||Adjusted mean difference|-0.09||||0.561|2-Sided|95.0|-0.41|0.22|||Mixed Models Analysis||Adjusted mean difference from placebo||
1649797|NCT01714817|3035305|Superiority or Other||Adjusted mean difference|-0.17||||0.571|2-Sided|95.0|-0.76|0.42|||Mixed Models Analysis||Adjusted mean difference from placebo||
1649798|NCT01714817|3035306|Superiority or Other||Odds Ratio (OR)|0.81|||||2-Sided|95.0|0.5994|1.5554|||||Abatacept IV:Placebo IV||
1649799|NCT01714817|3035307|Superiority or Other||Odds Ratio (OR)|1.08||||0.7264|2-Sided|95.0|0.8967|1.5726|||Stratified logistic regression||Abatacept IV:Placebo IV 95%CI for Odds Ratio||
1649800|NCT01714726|3035327|Superiority||Risk Difference (RD)|22.5|||=|0|2-Sided|90.0|8.3|36.8|||Regression, Logistic||||
1649801|NCT01714505|3035342|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1649802|NCT01714505|3035343|Superiority or Other||||||>|0.1|||||||t-test, 1 sided||||
1649803|NCT01714505|3035344|Superiority or Other|||||||0.003|||||||t-test, 1 sided|Paired t-tests: compare LBGI, carbohydrates for hypoglycemia treatment, % of time in range and average BG on CLC vs OL.|||
1649804|NCT01714336|3035351|Superiority or Other|||||||0.75|||||||Regression, Logistic||||
1649805|NCT01714323|3035359|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1649806|NCT01714323|3035360|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1649807|NCT01714323|3035361|Superiority or Other||||||<|0.001||||||This is the p value for the comparison at each follow up point: 1 mo, 3 mo, and 6 mo.|Chi-squared||||
1649808|NCT01714323|3035363|Superiority||||||<|0.09|||||||Chi-squared|||This is for Month 6|
1649809|NCT01714323|3035363|Superiority||||||<|0.01|||||||Chi-squared|||This is analysis for Month 3|
1649810|NCT01714323|3035363|Superiority or Other||||||<|0.001|||||||Chi-squared|||This compares at Month 1|
1649811|NCT01714323|3035364|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1649812|NCT01714323|3035365|Superiority or Other||Risk Ratio (RR)|1.07|||>|0.05|2-Sided|95.0|0.84|1.37|||Chi-squared|||Data from all three sites were combined after determining that outcomes did not vary by hospital using Breslow–Day tests. The proportion abstinent by treatment arm was assessed using chi-square test.|
1649813|NCT01714310|3035369|Superiority|||||||0.14||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=2.15, df=1/223|||
1649814|NCT01714310|3035369|Superiority|||||||0.59||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.29, df=1/223|||
1649815|NCT01714310|3035369|Superiority|||||||0.15||||||Group: F=2.05, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|||
1649816|NCT01714310|3035370|Superiority|||||||0.73||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.12, df=1/223|||
1649817|NCT01714310|3035370|Superiority|||||||0.21||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=1.60, df=1/223|||
1649851|NCT01713946|3035412|Superiority||Difference in least square means|-1.1|||||2-Sided|95.0|-4.4|2.1|||||||
1649819|NCT01714310|3035371|Superiority|||||||0.49||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.47, df=1/223|||
1649820|NCT01714310|3035371|Superiority|||||||0.18||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=1.77, df=1/223|||
1649821|NCT01714310|3035371|Superiority|||||||0.02||||||Group: F=5.42, df=1/223|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|||
1649822|NCT01714310|3035372|Superiority|||||||0.0004||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=12.86, df=1/222|||
1649823|NCT01714310|3035372|Superiority||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=63.11, df=1/222|||
1649824|NCT01714310|3035372|Superiority||||||<|0.21||||||Group: F=1.56, df=1/222|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|||
1649825|NCT01714310|3035373|Superiority|||||||0.13||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=.66, df=1/220|||
1649826|NCT01714310|3035373|Superiority|||||||0.42||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.66, df=1/220|||
1649827|NCT01714310|3035373|Superiority|||||||0.38||||||Group: F=.78, df=1/220|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).|||
1649828|NCT01714310|3035374|Superiority|||||||0.76|||||||Chi-squared|Chi Square = .10, df=1, p=.76|||
1649829|NCT01714310|3035375|Superiority|||||||0.02||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=5.42, df=1/145|||
1649830|NCT01714310|3035375|Superiority|||||||0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Tie: F=15.28, df=1/145|||
1649831|NCT01714310|3035375|Superiority|||||||0.05||||||Group: F=3.81, df=1/145|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|||No significant group*time interactions. Group trend likely due to baseline differences.
1649832|NCT01714310|3035376|Superiority|||||||0.04||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=4.40, df=1/157|||
1649833|NCT01714310|3035376|Superiority||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=22.39, df=1/157|||
1649834|NCT01714310|3035376|Superiority||||||<|0.44||||||Group: F=.60, df=1/157|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|||
1649835|NCT01714310|3035377|Superiority||||||<|0.0001||||||Time: F=26.36, df=1/29, p <.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.|||
1649836|NCT01714310|3035378|Superiority||||||<|0.0001||||||Time: F=40.35, df=1/89, p < .0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.|||
1649837|NCT01714310|3035379|Superiority||||||<|0.0001||||||Time: F=26.65, df=1/92, p <.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.|||
1649838|NCT01714310|3035380|Superiority||||||<|0.0001||||||Time: F=41.85, df=1/89, p<.0001.|Mixed Models Analysis|Linear regression of outcome change over time within single group.|||
1649839|NCT01714310|3035381|Superiority||||||<|0.0001||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=64.90, df=1/44|||
1649840|NCT01714310|3035381|Superiority||||||<|0.0002||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=136.22, df=1/44|||
1649841|NCT01714310|3035381|Superiority||||||<|0.97||||||Group: F=0.00, df=1/44|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline through week 12) and time2 (weeks 4-12).|||
1649842|NCT01714310|3035382|Superiority|||||||0.26||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time2: F=1.28, df=1/140|||
1649843|NCT01714310|3035382|Superiority|||||||0.85||||||Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|Mixed Models Analysis|Time: F=.03, df=1/140|||
1649844|NCT01714310|3035382|Superiority|||||||0.58||||||Group: F=.31, df=1/140|Mixed Models Analysis|Partial linear regression using mixed model, assessing outcome variable over time (baseline to study week 12) and time2 (study weeks 4-12).|||
1649845|NCT01714063|3035390|Other|We used a paired T-test for statistical analysis to compare the filter dose. Using the 1% significance level and assuming a between-subject standard deviation of 60 lg (27%) for the difference between coordinated and doses, 32 subjects are sufficient to detect a 45 lg (20%) difference with 95% confidence.uncoordinated filter|||||<|0.001|||||||paired t-test||||
1649846|NCT01713946|3035410|Superiority||Difference in least square means|-7.7|||||2-Sided|95.0|-22.0|6.6|||||||
1649847|NCT01713946|3035410|Superiority||Difference in least square means|-2.8|||||2-Sided|95.0|-17.9|12.3|||||||
1649848|NCT01713946|3035411|Superiority||Difference in least square means|0.4|||||2-Sided|95.0|-7.8|8.6|||||||
1649849|NCT01713946|3035411|Superiority||Difference in least square means|-2.1|||||2-Sided|95.0|-10.5|6.2|||||||
1649854|NCT01713946|3035414|Superiority||Mean Difference (Final Values)|4.2|||||2-Sided|95.0|2.5|5.9|||||||
1649855|NCT01713946|3035414|Superiority||Mean Difference (Final Values)|1.4|||||2-Sided|95.0|-0.4|3.1|||||||
1649856|NCT01713946|3035416|Superiority||Odds Ratio (OR)|3.82|||||2-Sided|95.0|2.25|6.48|||||||
1649857|NCT01713946|3035416|Superiority||Odds Ratio (OR)|1.77|||||2-Sided|95.0|1.05|2.97|||||||
1649858|NCT01713946|3035417|Superiority||Odds Ratio (OR)|4.99|||||2-Sided|95.0|0.57|44.03|||||||
1649859|NCT01713946|3035417|Superiority||Odds Ratio (OR)|6.55|||||2-Sided|95.0|0.77|55.73|||||||
1649860|NCT01713946|3035418|Superiority||Odds Ratio (OR)|27.46|||<|0.001|2-Sided|95.0|16.36|43.36|||Bonferroni-Holm||||
1649861|NCT01713946|3035418|Superiority||Median Difference (Final Values)|15.96|||<|0.003|2-Sided|95.0|1.98|31.68|||Bonferroni-Holm||||
1649862|NCT01713946|3035419|Superiority||Odds Ratio (OR)|3.93|||<|0.001|2-Sided|95.0|2.1|7.32|||Bonferroni-Holm||||
1649863|NCT01713946|3035419|Superiority||Odds Ratio (OR)|2.21|||<|0.008|2-Sided|95.0|1.16|4.2|||Bonferroni-Holm||||
1649864|NCT01713868|3035429|Other|Causal mediation analysis|Difference in proportions|0.15|||||2-Sided|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.
1649865|NCT01713868|3035430|Other|Causal mediation analysis|Difference in proportions|0.14|||||2-Sided|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.
1649866|NCT01713868|3035431|Other|Causal mediation analysis|Difference in proportions|0.14|||||2-Sided|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.
1649867|NCT01713868|3035432|Other|Causal mediation analysis|Difference in proportions|0.16|||||2-Sided|95.0|||||||||We performed causal mediation analyses to estimate the Total Effect of intervention on a categorical outcome as the difference in the proportion with the outcome for those who received the intervention and were positive on the mediator vs. those who received the control and were negative on the mediator. Significance is determined through 95% confidence intervals (CIs), with CIs not including 0.0 indicating significant effects.
1649868|NCT01713868|3035433|Superiority|GEE logistic regression accounted for within-hospital clustering, individual-level & hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect p=0.33. Adjusted mHealth effect p<0.001. Test for interaction p=0.29.|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.|
1649869|NCT01713868|3035434|Superiority|GEE logistic regression accounted for within-hospital clustering, individual-level & hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect p=0.07. Adjusted mHealth effect p<0.001. Test for interaction p=0.54|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.|
1649870|NCT01713868|3035435|Superiority|GEE logistic regression accounted for within-hospital clustering, individual-level & hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was not significant, we only presented main effects model.|||||<|0.001||||||Adjusted education effect: p=0.22. Adjusted mHealth effect p<0.001. Test for interaction p=0.08.|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction. We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p<0.05). Allowing for 20% loss to follow-up,this led to a sample of n=1600.|
1649899|NCT01712009|3035645|Superiority or Other||Difference|-1.3|||||2-Sided|95.0|-6.1|3.6|||||Loratadine minus No Prophylaxis|Difference across all cycles|
1649900|NCT01712009|3035645|Superiority or Other||Difference|-1.7|||||2-Sided|95.0|-6.5|3.2|||||Naproxen minus No Prophylaxis|Difference across all treatment cycles|
1649901|NCT01712009|3035646|Superiority or Other||Difference|1.8|||||2-Sided|95.0|-8.3|12.0|||||Loratadine minus Naproxen|Dfference across all treatment cycles|
1650599|NCT01700140|3037270|Superiority or Other|||||||0.1617|||||||Fisher Exact|||Statistical analysis for complete control rate after the third irradiation|
1649871|NCT01713868|3035436|Superiority|GEE logistic regression accounted for within-hospital clustering, individual-level & hospital-level covariates. We converted aORs to aRDs (95% CI) using the BF/BF group as the control group prevalence and reported separate effects of the 2 interventions. We fit multiplicative interaction models with indicator variables for education, mHealth, and their interaction. As the interaction between interventions was significant, we presented results from the interaction model.||||||0.03||||||Adjusted education effect p=0.34. Adjusted mHealth effect p<0.001. Test for interaction p=0.01. Adjusted education only effect p=0.74. Adjusted mHealth only effect p=0.02. Adjusted mHealth and education effect: p=0.03|Regression, Logistic|||Sample size provided power of detecting the effect of an individual intervention in the presence of interaction.We assumed pre-study prevalence of a safe sleep practice ranging from 50% to 60% across hospitals. We powered the study to detect a 10 percentage point difference between two study groups, and determined that an analysis sample of n=1280 (320 per treatment group) was needed for 80% power (testing at two-sided p<0.05). Allowing for 20% loss to follow-up, this led to a sample of n=1600.|
1649872|NCT01713348|3035469|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Deviation|1.1||0.0002|2-Sided|95.0|-1.24|-0.45|||t-test, 2 sided||||
1649873|NCT01713348|3035469|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Deviation|0.8||0.058|2-Sided|95.0|-0.59|0.01|||t-test, 2 sided||||
1649874|NCT01713348|3035470|Superiority or Other||Mean Difference (Final Values)|-9.0|Standard Deviation|12.0||0.0002|2-Sided|95.0|-13.6|-4.9|||t-test, 2 sided||||
1649875|NCT01713348|3035470|Superiority or Other||Mean Difference (Final Values)|-3.0|Standard Deviation|8.0||0.058|2-Sided|95.0|-6.4|0.1|||t-test, 2 sided||||
1649876|NCT01713348|3035471|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Deviation|0.7||0.0506|2-Sided|95.0|-0.54|0.0|||t-test, 2 sided||||
1649877|NCT01713348|3035471|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Deviation|0.6||0.0352|2-Sided|95.0|-0.51|-0.02|||t-test, 2 sided||||
1649878|NCT01713348|3035472|Superiority or Other||Mean Difference (Final Values)|0.27|Standard Deviation|1.05||0.7969|2-Sided|95.0|-1.86|2.4|||ANCOVA|Performed for each type of Diabetes and adjusted for baseline Time in Range.|||
1649879|NCT01713348|3035472|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Deviation|1.18||0.8367|2-Sided|95.0|-2.65|2.16|||ANCOVA|Performed for each type of Diabetes and adjusted for baseline Time in Range.|||
1649880|NCT01713348|3035473|Superiority or Other||Mean Difference (Final Values)|1.4|Standard Deviation|3.5||0.0427|2-Sided|95.0|0.05|2.73|||t-test, 2 sided|||Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.|
1649881|NCT01713348|3035473|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Deviation|3.3||0.9345|2-Sided|95.0|-1.29|1.19|||t-test, 2 sided||||
1649882|NCT01712490|3035559|Superiority||Hazard Ratio (HR)|0.728||||0.199|2-Sided|95.0|0.448|1.184|||Log Rank|||Hazard ratio (A+AVD/ABVD) and 95% CI are based on a stratified Cox’s proportional hazard regression model with stratification factors region and number of IPFP risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio <1 favors A+AVD arm.|
1649883|NCT01712490|3035560|Superiority||Hazard Ratio (HR)|0.77||||0.035|2-Sided|95.0|0.603|0.983|||Log Rank|||Hazard ratio (A+AVD/ABVD) and 95% confidence interval (CI) are based on a stratified Cox’s proportional hazard regression model with stratification factors region and number of International Prognostic Factor Project (IPFP) risk factors at baseline with treatment as the explanatory variable in the model. Hazard ratio less than (<) 1 favors A+AVD arm.|
1649884|NCT01712334|3035581|Non-Inferiority or Equivalence|The ratio of the mean percent predicted FEV1 at the end of the eRapid treatment to the mean percent predicted FEV1 at the end of the LC Plus jet nebulizer treatment. The two nebulizers were considered equivalent if the 90% CI was within 80%−125%.|Ratio (Fieller’s theorem)|100.9|||||2-Sided|90.0|99.5|102.3|||||||
1649885|NCT01712204|3035591|Superiority or Other||Risk Ratio (RR)|0.81|Standard Error of the Mean|0.113||0.1356|2-Sided|95.0|0.62|1.07|||Possion regression||||
1649886|NCT01712074|3035623|Superiority or Other||Mean Difference (Net)|2.194|Standard Error of the Mean|1.7149||0.2027|2-Sided|80.0|-0.013|4.401|||Mixed Models Analysis||||
1649887|NCT01712074|3035624|Superiority or Other||Mean Difference (Net)|0.695|Standard Error of the Mean|0.8697||0.4256|2-Sided|80.0|-0.424|1.814|||Mixed Models Analysis||||
1649888|NCT01712061|3035640|Superiority or Other||Ratio of geometric mean changes|0.92|||||2-Sided|95.0|0.75|1.09|||||||
1649889|NCT01712009|3035642|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.7||0.7572|2-Sided|95.0|-1.7|1.2|||ANOVA||Loratadine minus Naproxen|Difference across all treatment groups|
1649890|NCT01712009|3035642|Superiority or Other||LS Mean Difference|-1.6|Standard Error of the Mean|0.8||0.0329|2-Sided|95.0|-3.1|-0.1|||ANCOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles|
1649891|NCT01712009|3035642|Superiority or Other||LS Mean Difference|-1.4|Standard Error of the Mean|0.8||0.0775||95.0|-3.0|0.2|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles|
1649892|NCT01712009|3035643|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.3||0.5689|2-Sided|95.0|-0.8|0.5|||ANOVA||Loratadine minus Naproxen|Difference across all treatment cycles|
1649893|NCT01712009|3035643|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|0.3||0.0411|2-Sided|95.0|-1.3|0.0|||ANOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles|
1649894|NCT01712009|3035643|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|0.3||0.1466|2-Sided|95.0|-1.1|0.2|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles|
1649895|NCT01712009|3035644|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.2||0.8007|2-Sided|95.0|-0.4|0.3|||ANOVA||Loratadine minus Naproxen|Difference across all treatment cycles|
1649896|NCT01712009|3035644|Superiority or Other||LS Mean Difference|-0.4|Standard Deviation|0.2||0.0443|2-Sided|95.0|-0.7|0.0|||ANOVA||Loratadine minus No Prophylaxis|Difference across all treatment cycles|
1649897|NCT01712009|3035644|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.2||0.0881|2-Sided|95.0|-0.7|0.0|||ANOVA||Naproxen minus No Prophylaxis|Difference across all treatment cycles|
1649898|NCT01712009|3035645|Superiority or Other||Difference|0.4|||||2-Sided|95.0|-4.1|4.9|||||Loratadine minus Naproxen|Difference across all cycles|
1649902|NCT01712009|3035646|Superiority or Other||Difference|-2.4|||||2-Sided|95.0|-12.5|7.8|||||Loratadine minus No Prophylaxis|Difference across all treatment cyces|
1649903|NCT01712009|3035646|Superiority or Other||Difference|-4.2|||||2-Sided|95.0|-14.4|6.0|||||Naproxen minus No Prophylaxis|Difference across all treatment cycles|
1649904|NCT01712009|3035647|Superiority or Other||Difference|2.2|||||2-Sided|95.0|-8.0|12.4|||||Loratadine minus Naproxen||
1649905|NCT01712009|3035647|Superiority or Other||Difference|-4.1|||||2-Sided|95.0|-14.5|6.3|||||Loratadine minus No Prophylaxis||
1649906|NCT01712009|3035647|Superiority or Other||Difference|-6.3|||||2-Sided|95.0|-16.7|4.1|||||Naproxen minus No Prophylaxis||
1649907|NCT01711853|3035655|Superiority or Other|||||||0.9201|||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||Patients were classified based on the gender distribution.|
1649908|NCT01711853|3035655|Superiority or Other|||||||0.9734|||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: > median age).~Median is calculated based on trial data of treated set"|
1649909|NCT01711853|3035655|Superiority or Other|||||||0.4692|||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR, 2: > median GFR).~Median is calculated based on trial data of treated set"|
1649910|NCT01711853|3035656|Superiority or Other|||||||0.7853|||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||Patients were classified based on the gender distribution.|
1649911|NCT01711853|3035656|Superiority or Other|||||||0.9883|||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median age, 2: > median age).~Median is calculated based on trial data of treated set"|
1649912|NCT01711853|3035656|Superiority or Other|||||||0.5186|||||||ANOVA|ANOVA model on the logarithmic scale; effects accounting for the following sources of variation: 'gender', 'age group', and 'renal function group'.||"Patients were classified into groups for renal function based on the median values for renal function (1: ≤ median GFR (Glomerular filtration rate), 2: > median GFR).~Median is calculated based on trial data of treated set"|
1649913|NCT01711619|3035702|Superiority or Other||||||<|0.0001||||||Nominal alpha of 5% was pre-defined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation for ITT.|
1649914|NCT01711619|3035703|Superiority or Other|||||||0.0002||||||Nominal alpha of 5% was pre-defined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation for ITT.|
1649915|NCT01711619|3035704|Superiority or Other||||||<|0.0001||||||Nominal alpha of 5% was pre-defined for the final analysis.|Regression, Linear||||
1649916|NCT01711619|3035705|Superiority or Other||||||<|0.0001||||||Nominal alpha of 4% was predefined for the final analysis.|Fisher Exact|||Subjects with missing information were considered in the test and computation of the proportion for ITT.|
1649917|NCT01711372|3035718|Other|AUC of ROC|||||||||||||||||AUC of ROC. Proportion of accurate ADHD diagnosis is 0.62
1649918|NCT01711372|3035719|Other||||||||||||||||||AUC of ROC. Proportion of accurate ADHD diagnoses is 0.76
1649919|NCT01711372|3035720|Other|||||||||||||||||AUC or ROC for Groundskeeper Game|AUC of ROC is 0.78
1649920|NCT01711359|3035742|Non-Inferiority or Equivalence (legacy)|Noninferiority is concluded if the lower bound of the 95% CI for the difference in response rate is >-12%|Newcombe-Wilson method|14.8|||||2-Sided|95.0|5.5|24.1|||||Estimation Parameter: Newcombe-Wilson method without continuity correction for difference in the response rate (Baricitinib minus Methotrexate).||
1649921|NCT01711216|3035744|Superiority or Other|||||||0.3181||||||Test statistic (d.f.) 1.0157 (1) A Mantel–Haenszel chi-square test was used, exact p-value was computed using Monte Carlo estimation.|Mantel Haenszel|||Test of association between the number of regular menstrual cycles during the follow-up period and the number of dydrogesterone therapy cycles received during the treatment period (Follow-up Analysis Set) Follow-up Analysis Set (N=915)|
1649922|NCT01710657|3035806|Superiority or Other||% Reduction over Placebo|29.4|||<|0.001|2-Sided|95.0|18.7|38.7||Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.|ANCOVA|||"To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.~If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group."|
1649923|NCT01710657|3035806|Superiority or Other||% Reduction over Placebo|39.6|||<|0.001|2-Sided|95.0|30.5|47.6||Significant at the 0.05 level. This testing procedure is considered a closed testing procedure and no adjustment of the significance level was necessary.|ANCOVA|||"To avoid inflation of Type I error, hypothesis testing followed predefined hierarchical procedure starting LCM 400 mg/day treatment group versus the placebo group.~If the test was not statistically significant, the procedure stopped and no Groups were declared different from placebo. If the test was statistically significant, the treatment group was considered different from placebo and the procedure continued with the LCM 200 mg/day treatment group."|
1649924|NCT01710527|3035815|Non-Inferiority or Equivalence|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed AUC0-infinity fell within the acceptance range of 80 to 125%.|Ratio (%)|102.44||||0.2702|2-Sided|90.0|98.78|106.23|||ANOVA||Analysis was performed on log transformed geometric least square means.|Comparison of Treatment T-Metformin 500 mg and Treatment R- Glucophage 500 mg for AUC0-infinity.|
1650014|NCT01709318|3036104|Other|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|0.09||||1|||||||LDA||||
1649925|NCT01710527|3035815|Non-Inferiority or Equivalence|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed AUC0-t fell within the acceptance range of 80 to 125%.|Ratio (%)|102.52||||0.2701|2-Sided|90.0|98.74|106.45|||ANOVA|||Comparison of Treatment T-Metformin 500 mg and Treatment R- Glucophage 500 mg for AUC0-t|
1649926|NCT01710527|3035816|Non-Inferiority or Equivalence|Bioequivalence of Treatment T-Metformin 500 mg with Treatment R- Glucophage 500 mg was concluded if the 90% confidence intervals for the ratio of log transformed Cmax fell within the acceptance range of 80 to 125%.|Ratio (%)|96.85||||0.3125|2-Sided|90.0|91.86|102.11|||ANOVA||Analysis was performed on log transformed geometric least square means.||
1649927|NCT01710514|3035821|Non-Inferiority or Equivalence|The null hypothesis (H0) was tested against the alternative (Ha) by constructing two-sided 95%CI for the difference. The non-inferiority limit for the difference was pre-specified to -10.0% (absolute). If the lower limit of the two-sided 95%CI was greater than the non-inferiority limit (-10.0%) for both the FAS and per protocol set, the null hypothesis was to be rejected. In that case it would be claimed that the rate observed in this trial was non-inferior to the rate observed in the CS08 trial|Difference of % to historical control|-0.9|||||2-Sided|95.0|-3.6|1.8||||||To verify sufficient supplementation of luteal hormone, the proportion of subjects with blood progesterone concentration ≥ 10 ng/mL on Day 5 was compared to the result from a historical control, trial CS08 (NCT number: 00884221). The corresponding proportion of subjects in trial CS08 was 99.8% (95%CI: 99.1;100.0, 631/632 subjects). The non-inferiority hypothesis tested for this primary endpoint was: H0: P(000072)-P(CS08) ≤ -10.0% against the alternative Ha: P(000072)-P(CS08) > -10.0%.|
1649928|NCT01710358|3035849|Superiority or Other (legacy)|||||||0.001|||||||Regression, Logistic||||
1649929|NCT01710345|3035850|Superiority or Other||Mean Difference (Final Values)|13.66|Standard Error of the Mean|4.47||0.003|1-Sided|95.0|||||ANCOVA||||
1649930|NCT01710345|3035850|Superiority or Other||Mean Difference (Final Values)|1.47|Standard Error of the Mean|4.45||0.742|1-Sided|95.0|||||ANCOVA||||
1649931|NCT01710306|3035854|Superiority|||||||0.1996|||||||Chi-squared||||
1649932|NCT01709799|3035958|Superiority or Other|||||||0.498||||||P-value is not adjusted for multiple comparisons, and p < .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,115.593)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value > .05)|
1649933|NCT01709799|3035958|Superiority or Other|||||||0.63||||||P-value is not adjusted for multiple comparisons, and p < .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,115.573)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value > .05)|
1649934|NCT01709799|3035959|Superiority or Other|||||||0.313||||||P-value is not adjusted for multiple comparisons, and p < .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,93.167)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value > .05)|
1649935|NCT01709799|3035959|Superiority or Other||||||<|0.001||||||P-value is not adjusted for multiple comparisons, and p < .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,93.240)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value > .05)|
1649936|NCT01709799|3035960|Superiority or Other|||||||0.026||||||P-value is not adjusted for multiple comparisons, and p < .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,102.216)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value > .05)|
1649937|NCT01709799|3035960|Superiority or Other||||||<|0.001||||||P-value is not adjusted for multiple comparisons, and p < .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,102.315)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value > .05)|
1649938|NCT01709799|3035961|Superiority or Other|||||||0.781||||||P-value is not adjusted for multiple comparisons, and p < .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,99.601)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value > .05)|
1649939|NCT01709799|3035961|Superiority or Other||||||<|0.001||||||P-value is not adjusted for multiple comparisons, and p < .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,99.647)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value > .05)|
1649940|NCT01709799|3035962|Superiority or Other|||||||0.254||||||P-value is not adjusted for multiple comparisons, and p < .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (4,97.108)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value > .05)|
1649941|NCT01709799|3035962|Superiority or Other||||||<|0.001||||||P-value is not adjusted for multiple comparisons, and p < .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,97.137)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value > .05)|
1649942|NCT01709799|3035963|Superiority or Other|||||||0.995||||||The p-value is not adjusted for multiple comparisons, and the a priori threshold for statistical significance was 0.05|Mixed Models Analysis|Degrees of freedom are (4,90.564)||Occasion by arm interaction. Null hypothesis of no group differences in improvement (Interaction has p-value > .05)|
1649943|NCT01709799|3035963|Superiority or Other||||||<|0.001||||||P-value is not adjusted for multiple comparisons, and p < .05 is the a priori threshold for statistical significance|Mixed Models Analysis|degrees of freedom are (2,90.577)||Occasion main effect. Null hypothesis is no improvement (Occasion main effect has p-value > .05)|
1649944|NCT01709786|3035964|Superiority or Other||Limits of agreement|-0.63|||||2-Sided||||||||Limits of agreement are -3.44 to 2.18. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.||
1649945|NCT01709786|3035965|Superiority or Other||Bland-Altman Analysis|1.49|||||2-Sided||||||||Limits of agreement are -2.02 to 5.00. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.||
1650015|NCT01709318|3036104|Other|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.04||||1|||||||LDA||||
1649946|NCT01709578|3036015|Superiority or Other||LS Mean Difference|2.013||||0.0854|2-Sided|95.0|-0.282|4.309||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649947|NCT01709578|3036015|Superiority or Other||LS Mean Difference|1.515||||0.2026|2-Sided|95.0|-0.818|3.848||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649948|NCT01709578|3036016|Superiority or Other||LS Mean Difference|4.075|||<|0.0001|2-Sided|95.0|2.305|5.846||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649949|NCT01709578|3036016|Superiority or Other||LS Mean Difference|3.25|||<|0.0004|2-Sided|95.0|1.45|5.049||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649950|NCT01709578|3036017|Superiority or Other||LS Mean Difference|-0.242||||0.0004|2-Sided|95.0|-0.376|-0.109||Threshold for significance was 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649951|NCT01709578|3036017|Superiority or Other||LS Mean Difference|-0.183||||0.0078|2-Sided|95.0|-0.318|-0.048||Threshold for significance was 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649952|NCT01709578|3036018|Superiority or Other||LS Mean Difference|-9.727|||<|0.0001|2-Sided|95.0|-12.833|-6.622||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649953|NCT01709578|3036018|Superiority or Other||LS Mean Difference|-7.306|||<|0.0001|2-Sided|95.0|-10.444|-4.167||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649954|NCT01709578|3036019|Superiority or Other||Odds Ratio (OR)|5.801|||<|0.0001|2-Sided|95.0|2.948|11.413||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649955|NCT01709578|3036019|Superiority or Other||Odds Ratio (OR)|4.622|||<|0.0001|2-Sided|95.0|2.339|9.132||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649956|NCT01709578|3036020|Superiority or Other||Odds Ratio (OR)|2.653||||0.0056|2-Sided|95.0|1.308|5.383||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649957|NCT01709578|3036020|Superiority or Other||Odds Ratio (OR)|3.607||||0.0002|2-Sided|95.0|1.774|7.332||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649958|NCT01709578|3036021|Superiority or Other||Odds Ratio (OR)|3.374|||<|0.0001|2-Sided|95.0|2.045|5.566||Threshold for significance was 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649959|NCT01709578|3036021|Superiority or Other||Odds Ratio (OR)|2.958|||<|0.0001|2-Sided|95.0|1.764|4.959||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649960|NCT01709578|3036022|Superiority or Other||LS Mean Difference|-1.444|||<|0.0001|2-Sided|95.0|-1.752|-1.135||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649961|NCT01709578|3036022|Superiority or Other||LS Mean Difference|-0.971|||<|0.0001|2-Sided|95.0|-1.283|-0.658||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649962|NCT01709578|3036023|Superiority or Other||LS Mean Difference|-0.21||||0.0004|2-Sided|95.0|-0.325|-0.095||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649963|NCT01709578|3036023|Superiority or Other||LS Mean Difference|-0.202||||0.0007|2-Sided|95.0|-0.318|-0.086||Threshold for significance at 0.025 level|Mixed Models Analysis||Sarilumab 150 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649964|NCT01709578|3036024|Superiority or Other||Odds Ratio (OR)|3.284|||<|0.0001|2-Sided|95.0|2.108|5.115||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 200 mg q2w vs Placebo q2w|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1649965|NCT01709578|3036024|Superiority or Other||Odds Ratio (OR)|2.711|||<|0.0001|2-Sided|95.0|1.73|4.247||Threshold for significance at 0.025 level|Mantel Haenszel||Sarilumab 150 mg q2w vs Placebo q2w|A hierarchical testing procedure was used to control type I error rate at 0.05 and handle multiple endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.|
1649966|NCT01709513|3036033|Superiority or Other||LS Mean Difference|0.9|||=|0|2-Sided|95.0|-3.8|5.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649967|NCT01709513|3036034|Superiority or Other||Adjusted Mean Difference|-18.7|||<|0.0001|2-Sided|95.0|-25.5|-11.8||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1649968|NCT01709513|3036035|Superiority or Other||Odds Ratio (OR)|109.8|||<|0.0001|2-Sided|95.0|16.5|4759.3||Threshold for significance ≤ 0.05.|Regression, Exact Conditional Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a LOCF approach followed by Exact conditional logistic regression model.|
1649969|NCT01709513|3036036|Superiority or Other||Odds Ratio (OR)|71.5|||<|0.0001|2-Sided|95.0|11.1|3022.1||Threshold for significance ≤ 0.05.|Regression, Exact Conditional Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a last observation carried forward (LOCF) approach followed by Exact conditional logistic regression model.|
1649970|NCT01709513|3036037|Superiority or Other||Odds Ratio (OR)|24.9|||<|0.0001|2-Sided|95.0|8.6|71.9||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649971|NCT01709513|3036038|Superiority or Other||Odds Ratio (OR)|19.5|||<|0.0001|2-Sided|95.0|6.9|55.2||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649972|NCT01709513|3036039|Superiority or Other||LS Mean Difference|-21.1|||<|0.0001|2-Sided|95.0|-24.5|-17.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649973|NCT01709513|3036040|Superiority or Other||LS Mean Difference|-25.7|||<|0.0001|2-Sided|95.0|-29.9|-21.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649974|NCT01709513|3036041|Superiority or Other||LS Mean Difference|-24.5|||<|0.0001|2-Sided|95.0|-28.7|-20.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649975|NCT01709513|3036042|Superiority or Other||LS Mean Difference|-20.8|||<|0.0001|2-Sided|95.0|-24.7|-17.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649976|NCT01709513|3036043|Superiority or Other||LS Mean Difference|-29.8|||<|0.0001|2-Sided|95.0|-33.9|-25.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649977|NCT01709513|3036044|Superiority or Other||LS Mean Difference|-25.6|||<|0.0001|2-Sided|95.0|-30.4|-20.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649978|NCT01709513|3036045|Superiority or Other||LS Mean Difference|-28.2|||<|0.0001|2-Sided|95.0|-32.1|-24.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649979|NCT01709513|3036046|Superiority or Other||LS Mean Difference|-25.1|||<|0.0001|2-Sided|95.0|-29.8|-20.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649980|NCT01709513|3036047|Superiority or Other||LS Mean Difference|-33.1|||<|0.0001|2-Sided|95.0|-38.0|-28.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649981|NCT01709513|3036048|Superiority or Other||LS Mean Difference|-31.5|||<|0.0001|2-Sided|95.0|-36.9|-26.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649982|NCT01709513|3036049|Superiority or Other||LS Mean Difference|-35.1|||<|0.0001|2-Sided|95.0|-40.7|-29.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.|
1649983|NCT01709513|3036050|Superiority or Other||LS Mean Difference|-30.4|||<|0.0001|2-Sided|95.0|-36.6|-24.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Alirocumab group was compared to the corresponding active control group using an appropriate contrast statement.|
1649984|NCT01709500|3036051|Superiority or Other||LS Mean Difference|2.3|||=|0|2-Sided|95.0|-0.8|5.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649985|NCT01709500|3036052|Superiority or Other||Adjusted Mean Difference|-8.6|||=|0|2-Sided|95.0|-16.1|-1.1||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1649986|NCT01709500|3036053|Superiority or Other||LS Mean Difference|4.3|||=|0|2-Sided|95.0|0.9|7.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649987|NCT01709500|3036054|Superiority or Other||Adjusted Mean Difference|-19.1|||<|0.0001|2-Sided|95.0|-25.0|-13.1||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1649988|NCT01709500|3036055|Superiority or Other||LS Mean Difference|4.4|||=|0|2-Sided|95.0|1.3|7.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1651054|NCT01690273|3038181|Superiority or Other|||||||0.13|||||||Mixed Models Analysis||||
1649989|NCT01709500|3036056|Superiority or Other||Adjusted Mean Difference|-10.9|||=|0|2-Sided|95.0|-17.5|-4.3||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure. Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1649990|NCT01709500|3036057|Superiority or Other||LS Mean Difference|6.8|||=|0|2-Sided|95.0|2.8|10.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649991|NCT01709500|3036058|Superiority or Other||Adjusted Mean Difference|-20.3|||<|0.0001|2-Sided|95.0|-26.4|-14.2||Threshold for significance ≤ 0.05.|Regression, Robust|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.|
1649992|NCT01709500|3036059|Superiority or Other||Odds Ratio (OR)|240.6|||<|0.0001|2-Sided|95.0|31.4|1841.7||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649993|NCT01709500|3036060|Superiority or Other||Odds Ratio (OR)|239.7|||<|0.0001|2-Sided|95.0|31.6|1820.3||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649994|NCT01709500|3036061|Superiority or Other||Odds Ratio (OR)|53.3|||<|0.0001|2-Sided|95.0|21.4|132.6||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649995|NCT01709500|3036062|Superiority or Other||Odds Ratio (OR)|52.2|||<|0.0001|2-Sided|95.0|20.9|130.0||Threshold for significance ≤ 0.05.|Regression, Logistic|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.|
1649996|NCT01709500|3036063|Superiority or Other||LS Mean Difference|-58.8|||<|0.0001|2-Sided|95.0|-66.8|-50.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649997|NCT01709500|3036064|Superiority or Other||LS Mean Difference|-29.9|||<|0.0001|2-Sided|95.0|-34.5|-25.4|||Mixed Models Analysis|Threshold for significance ≤ 0.05.||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649998|NCT01709500|3036065|Superiority or Other||LS Mean Difference|-42.0|||<|0.0001|2-Sided|95.0|-47.8|-36.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1649999|NCT01709500|3036066|Superiority or Other||LS Mean Difference|-34.5|||<|0.0001|2-Sided|95.0|-39.2|-29.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1650000|NCT01709500|3036067|Superiority or Other||LS Mean difference|-32.8|||<|0.0001|2-Sided|95.0|-37.4|-28.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1650001|NCT01709500|3036068|Superiority or Other||LS Mean Difference|-46.4|||<|0.0001|2-Sided|95.0|-52.3|-40.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1650002|NCT01709500|3036069|Superiority or Other||LS Mean Difference|-45.7|||<|0.0001|2-Sided|95.0|-51.8|-39.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1650003|NCT01709500|3036070|Superiority or Other||LS Mean Difference|-39.8|||<|0.0001|2-Sided|95.0|-44.5|-35.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1650004|NCT01709500|3036071|Superiority or Other||LS Mean Difference|-39.3|||<|0.0001|2-Sided|95.0|-44.1|-34.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1650005|NCT01709500|3036072|Superiority or Other||LS Mean Difference|-48.8|||<|0.0001|2-Sided|95.0|-55.0|-42.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1650006|NCT01709500|3036073|Superiority or Other||LS Mean Difference|-48.4|||<|0.0001|2-Sided|95.0|-54.7|-42.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).|
1650007|NCT01709500|3036074|Superiority or Other||LS Mean Difference|-52.2|||<|0.0001|2-Sided|95.0|-58.7|-45.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.|
1650008|NCT01709500|3036075|Superiority or Other||LS Mean Difference|-51.4|||<|0.0001|2-Sided|95.0|-58.1|-44.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis|||Alirocumab group was compared to the placebo group using an appropriate contrast statement.|
1650009|NCT01709422|3036078|Superiority or Other||Mean Difference (Final Values)|28.0||||0.05|2-Sided|95.0|||||t-test, 2 sided||||
1650010|NCT01709422|3036079|Superiority or Other||Risk Difference (RD)|0.2||||0.05||95.0|||||Chi-squared||||
1650011|NCT01709383|3036092|Superiority or Other|||||||0.64|||||||Mixed Models Analysis||||
1650012|NCT01709383|3036094|Superiority or Other|||||||0.57|||||||Mixed Models Analysis||||
1650013|NCT01709318|3036104|Other|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.24||||0.998|||||||LDA||||
1650600|NCT01700140|3037270|Superiority or Other|||||||0.1047|||||||Fisher Exact|||Statistical analysis for complete control rate after the second irradiation|
1650016|NCT01709318|3036104|Other|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.06||||1|||||||LDA||||
1650017|NCT01709318|3036104|Other|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|0.19||||0.996|||||||LDA||||
1650018|NCT01709318|3036104|Other|Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of Least Squares (LS) Mean|-0.01||||1|||||||LDA||||
1650019|NCT01709318|3036105|Other|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.03||||0.995|||||||LDA||||
1650020|NCT01709318|3036105|Other|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.04||||0.976|||||||LDA||||
1650021|NCT01709318|3036105|Other|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.05||||0.845|||||||LDA||||
1650022|NCT01709318|3036105|Other|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.08||||0.124|||||||LDA||||
1650023|NCT01709318|3036105|Other|Based on longitudinal data analysis model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of LS Mean|-0.03||||0.993|||||||LDA||||
1650024|NCT01709318|3036105|Other|Based on longitudinal data analysis (LDA) model: generalized linear mixed model with terms for stratum, ring group, cycle (and the interaction of cycle by ring group), and continuous response variable.|Difference of Least Squares (LS) Mean|-0.08||||0.096|||||||LDA||||
1650025|NCT01709318|3036106|Non-Inferiority|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen’s method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||2-Sided|95.0|-6.2|11.0|||||95% CI adjusted for multiplicity (Dunnett)||
1650026|NCT01709318|3036106|Non-Inferiority|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen’s method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|1.4|||||2-Sided|95.0|-5.0|13.4|||||95% CI adjusted for multiplicity (Dunnett)||
1650027|NCT01709318|3036106|Non-Inferiority|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen’s method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|4.7|||||2-Sided|95.0|-2.5|18.9|||||95% CI adjusted for multiplicity (Dunnett)||
1650028|NCT01709318|3036106|Non-Inferiority|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen’s method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|3.0|||||2-Sided|95.0|-3.8|17.5|||||95% CI adjusted for multiplicity (Dunnett)||
1650029|NCT01709318|3036106|Non-Inferiority|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen’s method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||2-Sided|95.0|-6.2|11.0|||||95% CI adjusted for multiplicity (Dunnett)||
1650030|NCT01709318|3036106|Non-Inferiority|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen’s method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|3.2|||||2-Sided|95.0|-3.6|16.4|||||95% CI adjusted for multiplicity (Dunnett)||
1650031|NCT01709318|3036107|Non-Inferiority|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen’s method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|0.0|||||2-Sided|95.0|-10.7|15.9|||||95% CI adjusted for multiplicity (Dunnett)||
1650032|NCT01709318|3036107|Non-Inferiority|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen’s method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|9.3|||||2-Sided|95.0|-3.5|27.4|||||95% CI adjusted for multiplicity (Dunnett)||
1650033|NCT01709318|3036107|Non-Inferiority|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen’s method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|6.6|||||2-Sided|95.0|-5.7|25.4|||||95% CI adjusted for multiplicity (Dunnett)||
1650034|NCT01709318|3036107|Non-Inferiority|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen’s method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|12.3|||||2-Sided|95.0|-1.7|33.1|||||95% CI adjusted for multiplicity (Dunnett)||
1650035|NCT01709318|3036107|Non-Inferiority|Based on a LDA model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen’s method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|6.5|||||2-Sided|95.0|-5.7|24.8|||||95% CI adjusted for multiplicity (Dunnett)||
1651055|NCT01690273|3038181|Superiority or Other|||||||0.07|||||||Mixed Models Analysis||||
1650036|NCT01709318|3036107|Non-Inferiority|Based on a longitudinal data analysis (LDA) model with terms for treatment, cycle and the interaction cycle by treatment and stratum:starter/switcher followed by Miettinen and Nurminen’s method. Non-inferiority criterion was met if the upper bound of the 95% CI of the difference is less than or equal to 10%.|Difference in Percent|8.3|||||2-Sided|95.0|-4.3|26.5|||||95% CI adjusted for multiplicity (Dunnett)||
1650037|NCT01709305|3036110|Superiority or Other||Estimate|0.2||||0.318|2-Sided|95.0|-0.5|1.0|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650038|NCT01709305|3036110|Superiority or Other||Estimate|0.0|||>|0.999|2-Sided|95.0|-0.7|0.7|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650039|NCT01709305|3036110|Superiority or Other||Estimate|0.4|||>|0.158|2-Sided|95.0|-0.3|1.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650040|NCT01709305|3036111|Superiority or Other||Estimate|0.4||||0.48|2-Sided|95.0|-0.8|1.6|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650041|NCT01709305|3036111|Superiority or Other||Estimate|-0.2||||0.66|2-Sided|95.0|-1.3|0.8|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650042|NCT01709305|3036111|Superiority or Other||Estimate|-0.2||||0.651|2-Sided|95.0|-1.3|0.8|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650043|NCT01709305|3036112|Superiority or Other||Estimate|0.0||||0.999|2-Sided|95.0|-0.9|0.9|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650044|NCT01709305|3036112|Superiority or Other||Estimate|-0.2||||0.319|2-Sided|95.0|-1.0|0.5|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650045|NCT01709305|3036112|Superiority or Other||Estimate|0.0||||0.998|2-Sided|95.0|-0.9|0.9|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650046|NCT01709305|3036113|Superiority or Other||Estimate|0.2||||0.318|2-Sided|95.0|-0.5|1.0|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650047|NCT01709305|3036113|Superiority or Other||Estimate|0.0|||>|0.999|2-Sided|95.0|-0.7|0.7|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650048|NCT01709305|3036113|Superiority or Other||Estimate|0.4|||>|0.158|2-Sided|95.0|-0.3|1.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650049|NCT01709305|3036114|Superiority or Other||Estimate|-5.3|||<|0.001|2-Sided|95.0|-8.3|-2.5|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650050|NCT01709305|3036114|Superiority or Other||Estimate|-2.9|||<|0.072|2-Sided|95.0|-6.1|0.3|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650051|NCT01709305|3036114|Superiority or Other||Estimate|-8.4|||<|0.001|2-Sided|95.0|-11.1|-6.1|||Miettinen & Nurminen|||Difference in % vs. Glimepiride|
1650052|NCT01709305|3036116|Non-Inferiority or Equivalence|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|-0.05|||||2-Sided|98.34|-0.23|0.14||||||Pairwise Comparison|
1650053|NCT01709305|3036116|Non-Inferiority or Equivalence|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|0.03|||||2-Sided|98.34|-0.15|0.21||||||Pairwise Comparison|
1650054|NCT01709305|3036116|Non-Inferiority or Equivalence|Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Difference in LS Means|0.19|||||2-Sided|98.34|0.02|0.36||||||Pairwise Comparison|
1650055|NCT01709149|3036131|Superiority||Least squares mean difference|1.61|Standard Error of the Mean|3.207||0.6166|2-Sided|95.0|-4.7|7.91|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo||
1650056|NCT01709149|3036132|Superiority||Least squares mean difference|0.25|Standard Error of the Mean|4.399||0.9546|2-Sided|95.0|-8.4|8.9|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo||
1650057|NCT01709149|3036133|Superiority||Least squares mean difference|0.75|Standard Error of the Mean|0.956||0.4328|2-Sided|95.0|-1.13|2.63|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo||
1650058|NCT01709149|3036134|Superiority||Least squares mean difference|4.25|Standard Error of the Mean|1.03|<|0.0001|2-Sided|95.0|2.23|6.28|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo||
1650059|NCT01709149|3036135|Superiority||Least squares mean difference|-3.4|Standard Error of the Mean|1.627||0.0372|2-Sided|95.0|-6.6|-0.2|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo||
1650060|NCT01709149|3036136|Superiority||Least squares mean difference|0.48|Standard Error of the Mean|1.963||0.8083|2-Sided|95.0|-3.38|4.34|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo||
1650061|NCT01709149|3036137|Superiority||Least squares mean difference|-0.58|Standard Error of the Mean|0.366||0.114|2-Sided|95.0|-1.3|0.14|||Repeated-measures mixed model||Least squares mean difference: tirasemtiv minus placebo||
1650062|NCT01709110|3036142|Superiority||Least Squares Mean|0.0|Standard Error of the Mean|0.01||0.694|2-Sided|95.0|-0.02|0.01||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (US).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide – Risedronate.||
1650063|NCT01709110|3036143|Superiority||Least Squares Mean|0.0|Standard Error of the Mean|0.01||0.757|2-Sided|95.0|-0.03|0.02||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate baseline EQ-5D-5L (UK).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide – Risedronate.||
1650064|NCT01709110|3036144|Superiority||Least Squares Mean|-0.09|Standard Error of the Mean|0.17||0.585|2-Sided|95.0|-0.42|0.24||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline back pain (no pain - worst pain [0-10]).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.||
1650065|NCT01709110|3036145|Superiority||Least Squares Mean|-0.13|Standard Error of the Mean|0.08||0.093|2-Sided|95.0|-0.28|0.02||Model included the following fixed effects: treatment, visit, treatment-by-visit interaction, antecedent of recent clinical vertebral fractures, recent use of bisphosphonate and baseline body height(cm).|Mixed Models Analysis|An unstructured covariance matrix was assumed to account for the correlation between observations of the same participant.|Treatment difference was calculated as Teriparatide - Risedronate.||
1650066|NCT01709110|3036146|Superiority||Stratified Hazard Ratio (HR)|0.696||||0.078|2-Sided|95.0|0.461|1.05|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimates and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.||
1650067|NCT01709110|3036147|Superiority||Risk Ratio (RR)|0.1643||||0.007|2-Sided|95.0|0.036|0.744|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|||
1650068|NCT01709110|3036147|Superiority||Odds Ratio (OR)|0.1593||||0.007|2-Sided|95.0|0.035|0.728|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|||
1650069|NCT01709110|3036148|Superiority||Risk Ratio (RR)|0.4173|||<|0.001|2-Sided|95.0|0.27|0.646|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|||
1650070|NCT01709110|3036148|Superiority||Odds Ratio (OR)|0.3812|||<|0.001|2-Sided|95.0|0.237|0.614|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|||
1650071|NCT01709110|3036149|Superiority||Stratified Hazard Ratio (HR)|0.5786||||0.062432|2-Sided|95.0|0.318|1.052|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.||
1650072|NCT01709110|3036150|Superiority||Stratified Hazard Ratio (HR)|0.6553||||0.099023|2-Sided|95.0|0.39|1.101|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.||
1650073|NCT01709110|3036151|Superiority||Stratified Hazard Ratio (HR)|0.4831||||0.000869|2-Sided|95.0|0.316|0.739|||Stratified Log Rank|Stratified Log Rank test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|The Stratified Hazard Ratio estimate and corresponding 95% CI were obtained from the number of observed and expected events as part of the stratified log-rank test calculations.||
1650074|NCT01709110|3036152|Superiority||Risk Ratio (RR)|0.4561||||7.5e-05|2-Sided|95.0|0.305|0.682|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|||
1650075|NCT01709110|3036152|Superiority||Odds Ratio (OR)|0.4187||||7.5e-05|2-Sided|95.0|0.269|0.652|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|||
1650076|NCT01709110|3036153|Superiority||Risk Ratio (RR)|0.4431||||9.4e-05|2-Sided|95.0|0.29|0.677|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|||
1650077|NCT01709110|3036153|Superiority||Odds Ratio (OR)|0.4071||||9.4e-05|2-Sided|95.0|0.256|0.647|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was adjusted for the antecedent of recent clinical vertebral fractures and recent bisphosphonate use.|||
1650078|NCT01708954|3036169|Superiority or Other (legacy)||Hazard Ratio (HR)|0.39|||||2-Sided|80.0|0.27|0.55|||||Hazard ratio of Arm B/Arm A||
1650079|NCT01708954|3036169|Superiority or Other (legacy)||Hazard Ratio (HR)|0.37|||||2-Sided|80.0|0.25|0.53|||||Hazard ratio of Arm C/Arm A||
1650080|NCT01708941|3036172|Superiority|||||||0.868|||||||Log Rank|||Comparison of higher dose ipilimumab versus lower dose ipilimumab across HDI status (Arms A & B versus Arms C & D)|
1650081|NCT01708941|3036173|Superiority|||||||0.691|||||||Log Rank||||
1650082|NCT01708941|3036174|Superiority|||||||0.144|||||||Log Rank|||PFS comparison of higher dose ipilimumab versus lower dose ipilimumab (Arms A & B versus Arms C & D)|
1650083|NCT01708941|3036175|Superiority|||||||0.49|||||||Log Rank|||The primary comparison was ipilimumab + HDI versus ipilimumab alone, across ipilimumab dose (Arms A & C versus Arms B & D)|
1650084|NCT01708915|3036176|Superiority or Other||Odds Ratio (OR)|1.594||||0.0129||95.0|1.104|2.303|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Nonivamide. Odds ratios > 1 favour Nicoboxil/Nonivamide.||
1650085|NCT01708915|3036176|Superiority or Other||Odds Ratio (OR)|3.62|||<|0.0001||95.0|2.469|5.308|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Nicoboxil. Odds ratios > 1 favour Nicoboxil/Nonivamide.||
1650086|NCT01708915|3036176|Superiority or Other||Odds Ratio (OR)|7.385|||<|0.0001||95.0|4.943|11.032|||Regression, Logistic|The logistic regression model included baseline PI, centre, and treatment.|Odds Ratio was calculated by Nicoboxil/Nonivamide : Placebo. Odds ratios > 1 favour Nicoboxil/Nonivamide.||
1650087|NCT01708915|3036177|Superiority or Other||Mean Difference (Final Values)|-0.466|Standard Error of the Mean|0.209||0.0259||95.0|-0.875|-0.056|||ANCOVA|The statistical model included baseline PI, centre, and treatment.|||
1650088|NCT01708915|3036177|Superiority or Other||Mean Difference (Final Values)|-1.169|Standard Error of the Mean|0.209|<|0.0001||95.0|-1.578|-0.759|||ANCOVA|The statistical model included baseline PI, centre, and treatment.|||
1650089|NCT01708915|3036177|Superiority or Other||Mean Difference (Final Values)|-1.655|Standard Error of the Mean|0.208|<|0.0001||95.0|-2.064|-1.247|||ANCOVA|The statistical model included baseline PI, centre, and treatment.|||
1650107|NCT01708902|3036185|Superiority or Other||Odds Ratio (OR)|3.19|Standard Error of the Mean|1.243|<|0.0029|2-Sided|95.0|1.486|6.849|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650090|NCT01708915|3036178|Superiority or Other||Mean Difference (Final Values)|-0.058|Standard Error of the Mean|0.152||0.7037||95.0|-0.356|0.241||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.|||
1650091|NCT01708915|3036178|Superiority or Other||Mean Difference (Final Values)|-0.731|Standard Error of the Mean|0.138|<|0.0001||95.0|-1.003|-0.459||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.|||
1650092|NCT01708915|3036178|Superiority or Other||Mean Difference (Final Values)|-1.049|Standard Error of the Mean|0.13|<|0.0001||95.0|-1.305|-0.793||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.|||
1650093|NCT01708915|3036179|Superiority or Other||Mean Difference (Final Values)|-0.158|Standard Error of the Mean|0.195||0.4171||95.0|-0.541|0.225||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.|||
1650094|NCT01708915|3036179|Superiority or Other||Mean Difference (Final Values)|-0.983|Standard Error of the Mean|0.173|<|0.0001|2-Sided|95.0|-1.324|-0.642||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.|||
1650095|NCT01708915|3036179|Superiority or Other||Mean Difference (Final Values)|-1.362|Standard Error of the Mean|0.171|<|0.0001|2-Sided|95.0|-1.699|-1.025||Model included the fixed, categorical effects of treatment, centre, time, treatment-by-time interaction and the continuous covariate of baseline PI.|Restricted Maximum Likelihood (REML)|REML based on Repeated Measures Model, using all Available Longitudinal Pain Intensity Observations at each Post-baseline time up to 8 hours.|||
1650096|NCT01708902|3036180|Superiority or Other||Odds Ratio (OR)|0.114|Standard Error of the Mean|0.125||0.0474|2-Sided|95.0|0.013|0.976|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650097|NCT01708902|3036181|Superiority or Other||Odds Ratio (OR)|0.183|Standard Error of the Mean|0.147||0.0343|2-Sided|95.0|0.038|0.882|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi−complete separation of data points, the results shown are based on the last maximum likelihood iteration."|
1650098|NCT01708902|3036181|Superiority or Other||Odds Ratio (OR)|0.965|Standard Error of the Mean|0.916||0.9699|2-Sided|95.0|0.15|6.202|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi−complete separation of data points, the results shown are based on the last maximum likelihood iteration."|
1650099|NCT01708902|3036181|Superiority or Other||Odds Ratio (OR)|0.209|Standard Error of the Mean|0.148||0.0271|2-Sided|95.0|0.052|0.838|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c. The validity of the model is questionable as there is possibly a quasi−complete separation of data points, the results shown are based on the last maximum likelihood iteration."|
1650100|NCT01708902|3036182|Superiority or Other||Mean Difference (Final Values)|-35.21|Standard Error of the Mean|9.23||0.0002|2-Sided|95.0|-53.48|-16.95|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.|
1650101|NCT01708902|3036183|Superiority or Other||Mean Difference (Final Values)|-24.31|Standard Error of the Mean|3.17|<|0.0001|2-Sided|95.0|-30.54|-18.08|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.|
1650102|NCT01708902|3036183|Superiority or Other||Median Difference (Net)|-9.47|Standard Error of the Mean|3.16|<|0.0028|2-Sided|95.0|-15.66|-3.27|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.|
1650103|NCT01708902|3036183|Superiority or Other||Mean Difference (Final Values)|-32.42|Standard Error of the Mean|3.19|<|0.0001|2-Sided|95.0|-38.67|-26.16|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.|
1650104|NCT01708902|3036183|Superiority or Other||Mean Difference (Final Values)|-5.37|Standard Error of the Mean|3.23|<|0.0971|2-Sided|95.0|-11.72|0.98|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group.|
1650105|NCT01708902|3036184|Superiority or Other||Odds Ratio (OR)|1.865|Standard Error of the Mean|1.015||0.2523|2-Sided|95.0|0.642|5.42|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650106|NCT01708902|3036185|Superiority or Other||Odds Ratio (OR)|4.871|Standard Error of the Mean|1.846|<|0.0001|2-Sided|95.0|2.318|10.238|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650108|NCT01708902|3036185|Superiority or Other||Odds Ratio (OR)|3.093|Standard Error of the Mean|1.029|<|0.0007|2-Sided|95.0|1.612|5.938|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650109|NCT01708902|3036185|Superiority or Other||Odds Ratio (OR)|0.986|Standard Error of the Mean|0.387|<|0.9705|2-Sided|95.0|0.456|2.13|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650110|NCT01708902|3036186|Superiority or Other||Mean Difference (Final Values)|-1.25|Standard Error of the Mean|0.32||0.0001|2-Sided|95.0|-1.87|-0.63|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'APG: Linagliptin 5mg QD'.|"The treatment effect of the 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' was compared with 'APG: Linagliptin 5mg QD'.~The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate."|
1650111|NCT01708902|3036187|Superiority or Other||Mean Difference (Final Values)|-0.81|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-1.04|-0.58|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."|
1650112|NCT01708902|3036187|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.7|-0.24|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID ' minus 'Main: Metformin 500mg BID' .|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."|
1650113|NCT01708902|3036187|Superiority or Other||Mean Difference (Final Values)|-1.04|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-1.27|-0.81|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."|
1650114|NCT01708902|3036187|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.12|<|0.0109|2-Sided|95.0|-0.53|-0.07|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|"Sensitivity analysis: Mixed Model for repeated measurements~The model includes baseline HbA1c as a linear covariate; visit, treatment and visit by treatment interaction as fixed classification effects and patient as a random effect with unstructured covariance structure to model within-patients errors."|
1650115|NCT01708902|3036188|Superiority or Other||Odds Ratio (OR)|3.135|Standard Error of the Mean|1.31||0.0062|2-Sided|95.0|1.383|7.11|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650116|NCT01708902|3036189|Superiority or Other||Odds Ratio (OR)|4.682|Standard Error of the Mean|1.27|<|0.0001|2-Sided|95.0|2.751|7.968|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650117|NCT01708902|3036189|Superiority or Other||Odds Ratio (OR)|2.574|Standard Error of the Mean|0.655|<|0.0002|2-Sided|95.0|1.563|4.239|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650118|NCT01708902|3036189|Superiority or Other||Odds Ratio (OR)|5.923|Standard Error of the Mean|1.632|<|0.0001|2-Sided|95.0|3.452|10.164|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650119|NCT01708902|3036189|Superiority or Other||Odds Ratio (OR)|1.661|Standard Error of the Mean|0.426|<|0.048|2-Sided|95.0|1.004|2.746|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650120|NCT01708902|3036190|Superiority or Other||Odds Ratio (OR)|4.169|Standard Error of the Mean|1.565||0.0001|2-Sided|95.0|1.997|8.701|||Regression, Logistic|||"Comparison of 'APG: Linagliptin 2.5mg / Metformin 1000mg BID' / 'APG: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650121|NCT01708902|3036191|Superiority or Other||Odds Ratio (OR)|3.818|Standard Error of the Mean|1.023|<|0.0001|2-Sided|95.0|2.259|6.454|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650122|NCT01708902|3036191|Superiority or Other||Odds Ratio (OR)|2.829|Standard Error of the Mean|0.753|<|0.0001|2-Sided|95.0|1.678|4.767|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' / 'Main: Metformin 500mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650123|NCT01708902|3036191|Superiority or Other||Odds Ratio (OR)|5.489|Standard Error of the Mean|1.543|<|0.0001|2-Sided|95.0|3.164|9.522|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Linagliptin 5mg QD'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650124|NCT01708902|3036191|Superiority or Other||Odds Ratio (OR)|1.673|Standard Error of the Mean|0.487|<|0.0771|2-Sided|95.0|0.946|2.961|||Regression, Logistic|||"Comparison of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' / 'Main: Metformin 1000mg BID'.~The logistic regression includes treatment and continuous baseline HbA1c."|
1650167|NCT01706926|3036335|Superiority or Other||Adjusted geometric mean ratio|0.64|||<|0.017|2-Sided|95.0|0.45|0.92|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.||
1651056|NCT01690273|3038182|Superiority or Other|||||||0.645|||||||Mixed Models Analysis||||
1650125|NCT01708902|3036192|Superiority or Other||Mean Difference (Final Values)|-0.87|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-1.09|-0.64|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Linagliptin 5mg QD'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. ‘Greater effect’ refers to a greater reduction in HbA1c."|
1650126|NCT01708902|3036192|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-0.73|-0.29|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 500mg BID' minus 'Main: Metformin 500mg BID'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. ‘Greater effect’ refers to a greater reduction in HbA1c."|
1650127|NCT01708902|3036192|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-1.23|-0.78|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Linagliptin 5mg QD'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. ‘Greater effect’ refers to a greater reduction in HbA1c."|
1650128|NCT01708902|3036192|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.12|<|0.0587|2-Sided|95.0|-0.45|0.01|||ANCOVA||The adjusted mean difference was calculated as the adjusted mean of 'Main: Linagliptin 2.5mg / Metformin 1000mg BID' minus 'Main: Metformin 1000mg BID'.|"The model includes treatment as a fixed effect and baseline HbA1c as a linear covariate.~The null and alternative hypotheses were tested in a hierarchical sequence. The next null hypothesis was tested in a confirmatory way only if all prior null-hypotheses were rejected. 'Greater effect' refers to a greater reduction in HbA1c."|
1650129|NCT01708317|3036202|Superiority or Other||Mean Difference (Final Values)|5.0|||<|0.001||||||We used a cutoff of P<0.05 as statistically significant.|Chi-squared|3 degrees of freedom to compare 4 time periods.||We compared testing in the 4 time frames described, including the time frame in which we enrolled patients in the ACASI.|
1650130|NCT01708213|3036206|Superiority or Other||Parametric Testing|0.05|||<|0.05|2-Sided||||||Parametric testing||||
1650131|NCT01707992|3036251|Superiority||Hazard Ratio (HR)|0.937|||=|0|2-Sided|95.0|0.668|1.313||Threshold for significance at 0.05 level.|Cox proportional hazards model|||The primary analysis for the comparison between laquinimod 0.6 mg versus placebo was conducted using the baseline adjusted Cox proportional hazards model. Categorical EDSS at baseline (less than or equal to [<=] 4 or greater than [>] 4), country/geographical region (CGR), categorical age at baseline (<=38 or >38), and T2 volume at baseline were included as covariates in the model.|
1650132|NCT01707693|3036252|Other|counts of stage of change||||||0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Armitage trend test|||
1650133|NCT01707693|3036253|Other|2-sided Wilcoxon Rank Sum test||||||0.033|||||||Wilcoxon (Mann-Whitney)||||
1650134|NCT01707693|3036254|Superiority|||||||0.011||||||* P-value calculated from repeated measures model adjusting for age with a log transformation applied.|ANCOVA|* P-value calculated from repeated measures model adjusting for age with a log transformation applied.|||
1650135|NCT01707693|3036255|Superiority|repeated measures mixed model analysis of covariance, with the baseline measurement as a covariate.||||||0.023||||||P-value calculated from repeated measures model adjusting for age with a log transformation applied. P-values are one-sided.|ANCOVA||||
1650136|NCT01707667|3036257|Superiority or Other||Mean Difference (Final Values)|15.8||||0.225|2-Sided|95.0|-12.6|44.3|||Linear Mixed-Effect Models Analysis||||
1650137|NCT01707667|3036258|Superiority or Other||Mean Difference (Final Values)|-0.179||||0.18|2-Sided|95.0|-0.465|0.107|||Linear Mixed-Effect Models Analysis||||
1650138|NCT01707667|3036259|Superiority or Other|||||||0.295|||||||Log Rank||||
1650139|NCT01707667|3036260|Superiority or Other||Mean Difference (Final Values)|9.2||||0.717|2-Sided|95.0|-45.3|63.7|||Linear Mixed-Effect Models Analysis||||
1650140|NCT01707667|3036261|Superiority or Other||Mean Difference (Final Values)|69051.4||||0.079|2-Sided|95.0|-12004.5|150107.3|||Linear Mixed-Effect Models Analysis||||
1650141|NCT01707667|3036262|Superiority or Other||Mean Difference (Final Values)|5.8||||0.012|2-Sided|95.0|1.6|9.9|||Linear Mixed-Effect Models Analysis||||
1650142|NCT01707381|3036272|Other||Mean Difference (Final Values)|-1.77||||0.004|2-Sided|95.0|-2.915|-0.625|||ANOVA||Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.||
1650143|NCT01707381|3036273|Other||Bonferroni t-test used for paired compar|0.01|||<|0.05|2-Sided||||||ANOVA||the bonferroni result applies to nocturnal supine OPP data comparing BOL group to timolol group|Statistical analysis of nocturnal (supine) OPP was performed among baseline, the BOL-303259-X treatment and timolol treatment using ANOVA. the criteria for statistical significance was P<0.05. Post hoc Bonferroni T-tests were then utilized to compare BOL and timolol groups.|
1650144|NCT01707381|3036274|Other||Treatment difference|-1.773|||<|0.001|2-Sided|95.0|-2.38|-1.166|||ANCOVA||Treatment Difference = BOL-303259-X 0.024% - Timolol maleate 0.5%.||
1650145|NCT01707147|3036294|Other||Mean Difference (Final Values)|-18.05|Standard Deviation|61.84|<|0.0001|2-Sided|95.0|-20.98|-15.12|||Paired t-test||p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.||
1650146|NCT01707147|3036297|Other||Mean Difference (Final Values)|-0.77|Standard Deviation|1.5|<|0.0001|2-Sided|95.0|-0.83|-0.71|||Paired t-test||p-value of paired t-test for change from baseline is presented. 95% confidence interval for the mean was calculated using t-distribution.||
1650147|NCT01706965|3036322|Superiority|ANOVA, controlled for baseline MATRICS||||||0.99|||||||ANOVA||||
1650148|NCT01706965|3036323|Superiority|||||||0.38|||||||ANOVA|||Univariate ANOVA, controlling for baseline PANSS total|
1650224|NCT01706250|3036424|Superiority or Other||Mean Difference (Net)|0.56|Standard Deviation|1.1||0.0781||95.0|||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)|
1650149|NCT01706952|3036327|Superiority or Other|For surgical field grade, we calculated the mean within sides and assessed its difference, reporting a 95% confidence interval as calculated by a Student t test. We used the average per patient over time.||||||0.05|||||||t-test, 2 sided|||Data analysis was performed using SPSS version 13 for Windows (SPSS Inc, Chicago, IL). A power study was per formed with a power of 80% and a clinically significant difference in bleeding between the sides of 20% with a significance level of 5% (p < 0.05).|"For the primary objective of surgical field grade, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference, reporting a 95% con- fidence interval as calculated by a Student t test. As all of these values were measured over time, we used the average per patient over time. The total blood loss per side within subjects was also calculated, with 95% confidence interval again calculated by a Student t test. Once again, we took the average per patient over time as the main outcome.~Finally, we used a linear regression with surgical field improvement as the outcome and HR, MAP, or etCO2 as covariates, to investigate which variables may be related to the outcome. As these measures were taken over time, we used repeated measures analysis to investigate how these items correlate over time.~In addition to the operating surgeon, the statistician was blinded to the vasoconstrictor allocation."
1650150|NCT01706926|3036330|Superiority or Other||Adjusted mean difference|3.92|Standard Error of the Mean|1.578||0.014|2-Sided|95.0|0.81|7.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences >0 favored mavrilimumab.||
1650151|NCT01706926|3036330|Superiority or Other||Adjusted mean difference|2.27|Standard Error of the Mean|1.574||0.151|2-Sided|95.0|-0.83|5.37|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences >0 favored mavrilimumab.||
1650152|NCT01706926|3036330|Superiority or Other||Adjusted mean difference|1.18|Standard Error of the Mean|1.608||0.463|2-Sided|95.0|-1.99|4.35|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences >0 favored mavrilimumab.||
1650153|NCT01706926|3036331|Superiority or Other||Percent difference|1.3||||0.494|2-Sided|95.0|-1.2|3.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.||
1650154|NCT01706926|3036331|Superiority or Other||Percent difference|1.2||||1|2-Sided|95.0|-1.1|3.5|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.||
1650155|NCT01706926|3036331|Superiority or Other||Percent difference|3.7||||0.245|2-Sided|95.0|-0.4|7.8|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.||
1650156|NCT01706926|3036332|Superiority or Other||Percent difference|6.4||||0.062|2-Sided|95.0|0.0|12.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.||
1650157|NCT01706926|3036332|Superiority or Other||Percent difference|2.3||||0.621|2-Sided|95.0|-2.3|6.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.||
1650158|NCT01706926|3036332|Superiority or Other||Percent difference|4.9||||0.21|2-Sided|95.0|-0.8|10.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.||
1650159|NCT01706926|3036333|Superiority or Other||Percent difference|3.8||||0.207|2-Sided|95.0|-1.6|9.2|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.||
1650160|NCT01706926|3036333|Superiority or Other||Percent difference|1.1||||1|2-Sided|95.0|-2.9|5.1|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.||
1650161|NCT01706926|3036333|Superiority or Other||Percent difference|4.9||||0.21|2-Sided|95.0|-0.8|10.7|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response) with treatment as a factor. Differences >0 favored mavrilimumab.||
1650162|NCT01706926|3036334|Superiority or Other||Adjusted geometric mean ratio|0.61|||<|0.001|2-Sided|95.0|0.49|0.75|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.||
1650163|NCT01706926|3036334|Superiority or Other||Adjusted geometric mean ratio|0.68|||<|0.001|2-Sided|95.0|0.55|0.84|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.||
1650164|NCT01706926|3036334|Superiority or Other||Adjusted geometric mean ratio|0.72|||<|0.003|2-Sided|95.0|0.58|0.89|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.||
1650165|NCT01706926|3036335|Superiority or Other||Adjusted geometric mean ratio|0.44|||<|0.001|2-Sided|95.0|0.31|0.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.||
1650166|NCT01706926|3036335|Superiority or Other||Adjusted geometric mean ratio|0.46|||<|0.001|2-Sided|95.0|0.32|0.66|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model including terms for baseline as a continuous covariate and treatment as a factor was used for the analysis. Ratio <1 favored mavrilimumab.||
1650225|NCT01706250|3036424|Superiority or Other||Mean Difference (Net)|0.26|Standard Deviation|0.93||0.3984|||||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)|
1650168|NCT01706926|3036336|Superiority or Other||Adjusted mean difference|-0.26|Standard Error of the Mean|0.107||0.017|2-Sided|95.0|-0.47|-0.05|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.||
1650169|NCT01706926|3036336|Superiority or Other||Adjusted mean difference|-0.16|Standard Error of the Mean|0.106||0.124|2-Sided|95.0|-0.37|0.04|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.||
1650170|NCT01706926|3036336|Superiority or Other||Adjusted mean difference|-0.08|Standard Error of the Mean|0.108||0.479|2-Sided|95.0|-0.29|0.14|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.||
1650171|NCT01706926|3036337|Superiority or Other||Adjusted mean difference|-1.56|Standard Error of the Mean|0.391|<|0.001|2-Sided|95.0|-2.33|-0.79|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.||
1650172|NCT01706926|3036337|Superiority or Other||Adjusted mean difference|-1.46|Standard Error of the Mean|0.389|<|0.001|2-Sided|95.0|-2.23|-0.69|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.||
1650173|NCT01706926|3036337|Superiority or Other||Adjusted mean difference|-1.41|Standard Error of the Mean|0.397|<|0.001|2-Sided|95.0|-2.2|-0.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.||
1650174|NCT01706926|3036338|Superiority or Other||Adjusted mean difference|-5.48|Standard Error of the Mean|4.083||0.18|2-Sided|95.0|-13.52|2.55|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.||
1650175|NCT01706926|3036338|Superiority or Other||Adjusted mean difference|-2.19|Standard Error of the Mean|4.058||0.589|2-Sided|95.0|-10.18|5.79|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.||
1650176|NCT01706926|3036338|Superiority or Other||Adjusted mean difference|-0.85|Standard Error of the Mean|4.137||0.837|2-Sided|95.0|-8.99|7.29|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.||
1650177|NCT01706926|3036339|Superiority or Other||Adjusted mean difference|-11.32|Standard Error of the Mean|3.899||0.004|2-Sided|95.0|-19.0|-3.65|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.||
1650178|NCT01706926|3036339|Superiority or Other||Adjusted mean difference|-8.11|Standard Error of the Mean|3.876||0.037|2-Sided|95.0|-15.73|-0.48|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.||
1650179|NCT01706926|3036339|Superiority or Other||Adjusted mean difference|-7.94|Standard Error of the Mean|3.95||0.045|2-Sided|95.0|-15.72|-0.17|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.||
1650180|NCT01706926|3036340|Superiority or Other||Adjusted mean difference|-10.42|Standard Error of the Mean|1.901|<|0.001|2-Sided|95.0|-14.17|-6.67|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.|
1650181|NCT01706926|3036340|Superiority or Other||Adjusted mean difference|-8.45|Standard Error of the Mean|1.884|<|0.001|2-Sided|95.0|-12.16|-4.74|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.|
1650182|NCT01706926|3036340|Superiority or Other||Adjusted mean difference|-7.24|Standard Error of the Mean|1.922|<|0.001|2-Sided|95.0|-11.02|-3.45|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in tender joint count at Day 169.|
1650183|NCT01706926|3036340|Superiority or Other||Adjusted mean difference|-7.0|Standard Error of the Mean|1.219|<|0.001|2-Sided|95.0|-9.4|-4.59|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.|
1650202|NCT01706926|3036345|Superiority or Other||Percent difference|13.5|||<|0.03|2-Sided|95.0|1.8|25.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.||
1651057|NCT01690273|3038182|Superiority or Other|||||||0.098|||||||Mixed Models Analysis||||
1650184|NCT01706926|3036340|Superiority or Other||Adjusted mean difference|-6.21|Standard Error of the Mean|1.211|<|0.001|2-Sided|95.0|-8.6|-3.82|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.|
1650185|NCT01706926|3036340|Superiority or Other||Adjusted mean difference|-5.68|Standard Error of the Mean|1.237|<|0.001|2-Sided|95.0|-8.12|-3.24|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in swollen joint count at Day 169.|
1650186|NCT01706926|3036341|Superiority or Other||Percent difference|33.1|||<|0.001|2-Sided|95.0|20.7|45.6|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.|
1650187|NCT01706926|3036341|Superiority or Other||Percent difference|23.1|||<|0.001|2-Sided|95.0|11.5|34.8|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.|
1650188|NCT01706926|3036341|Superiority or Other||Percent difference|24.7|||<|0.001|2-Sided|95.0|12.7|36.6|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|The analysis reported DAS28 (CRP) low disease activity response.|
1650189|NCT01706926|3036341|Superiority or Other||Percent difference|14.0|||<|0.007|2-Sided|95.0|4.2|23.9|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.|
1650190|NCT01706926|3036341|Superiority or Other||Percent difference|12.7|||<|0.014|2-Sided|95.0|3.3|22.1|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.|
1650191|NCT01706926|3036341|Superiority or Other||Percent difference|16.0|||<|0.004|2-Sided|95.0|6.0|26.1|||Fisher Exact||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.|DAS28 (CRP) remission: p-value estimated from fisher's exact test when number of placebo or active responders was less than 5.|
1650192|NCT01706926|3036342|Superiority or Other||Odds Ratio (OR)|7.11|||<|0.001|2-Sided|95.0|3.85|13.4|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios >one favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.|
1650193|NCT01706926|3036342|Superiority or Other||Odds Ratio (OR)|4.81|||<|0.001|2-Sided|95.0|2.64|8.92|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios >one favored mavrilimumab.||
1650194|NCT01706926|3036342|Superiority or Other||Odds Ratio (OR)|4.7|||<|0.001|2-Sided|95.0|2.56|8.8|||Proportional odds analysis||Odds ratio, 95% CI and p-value were was calculated using proportional odds analysis of response model including treatment as a factor. Odds ratios greater than (>) one favored mavrilimumab.||
1650195|NCT01706926|3036343|Superiority or Other||Adjusted mean difference|27.47|Standard Error of the Mean|5.892|<|0.001|2-Sided|95.0|15.87|39.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.||
1650196|NCT01706926|3036343|Superiority or Other||Adjusted mean difference|16.99|Standard Error of the Mean|5.879|<|0.004|2-Sided|95.0|5.42|28.56|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.||
1650197|NCT01706926|3036343|Superiority or Other||Adjusted Mean difference|15.79|Standard Error of the Mean|6.007|<|0.009|2-Sided|95.0|3.96|27.61|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.||
1650198|NCT01706926|3036344|Superiority or Other||Percent difference|10.2||||0.026|2-Sided|95.0|1.5|18.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.||
1650199|NCT01706926|3036344|Superiority or Other||Percent difference|6.9||||0.133|2-Sided|95.0|-0.8|14.6|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.||
1650200|NCT01706926|3036344|Superiority or Other||Percent difference|8.6||||0.079|2-Sided|95.0|0.4|16.9|||Fisher Exact||95% unconditional exact CI was calculated using the model of logit (response). p-value estimated from fisher's exact test.||
1650201|NCT01706926|3036345|Superiority or Other||Percent difference|28.2|||<|0.001|2-Sided|95.0|15.2|41.1|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.||
1650223|NCT01706250|3036424|Superiority or Other||Mean Difference (Net)|0.39|Standard Deviation|1.24||0.375||95.0|||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)|
1650203|NCT01706926|3036345|Superiority or Other||Percent difference|16.0|||<|0.013|2-Sided|95.0|3.9|28.2|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.||
1650204|NCT01706926|3036352|Superiority or Other||Percent difference|48.7|||<|0.001|2-Sided|95.0|35.2|62.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.||
1650205|NCT01706926|3036352|Superiority or Other||Percent difference|36.5|||<|0.001|2-Sided|95.0|22.5|50.5|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.||
1650206|NCT01706926|3036352|Superiority or Other||Percent difference|25.9|||<|0.001|2-Sided|95.0|11.5|40.3|||Regression, Logistic||95% unconditional exact CI was calculated using a test of treatment difference in proportion of responders using logistic regression with treatment as a factor. Differences greater than zero favored mavrilimumab.||
1650207|NCT01706926|3036353|Superiority or Other||Adjusted mean difference|-1.22|Standard Error of the Mean|0.193|<|0.001|2-Sided|95.0|-1.6|-0.84|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.|
1650208|NCT01706926|3036353|Superiority or Other||Adjusted mean difference|-0.96|Standard Error of the Mean|0.19|<|0.001|2-Sided|95.0|-1.33|-0.58|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.|
1650209|NCT01706926|3036353|Superiority or Other||Adjusted mean difference|-0.69|Standard Error of the Mean|0.193|<|0.001|2-Sided|95.0|-1.06|-0.31|||Repeated measures model|||Analysis reported for change from baseline in DAS28 (CRP) at Day 85. An estimate of the treatment difference and its 95 percent (%) confidence interval (CI) was computed by means of repeated measures model, adjusted for baseline and including terms for treatment group, visit and treatment by visit interaction. Differences <0 favored mavrilimumab.|
1650210|NCT01706536|3036397|Superiority||Least Squares Mean (SE)|0.177|Standard Error of the Mean|0.03953|<|0.0001|2-Sided|95.0|0.0992|0.2548||in order to control for type I error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.|
1650211|NCT01706536|3036397|Superiority||Least Squares Mean (SE)|0.1462|Standard Error of the Mean|0.04037|<|0.0004|2-Sided|95.0|0.0667|0.2257||in order to control for Type 1 error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.|
1650212|NCT01706536|3036397|Superiority||Least Squares Mean (SE)|0.1284|Standard Error of the Mean|0.04089|<|0.0019|2-Sided|95.0|0.0479|0.2089||In order to control for Type I error rate, a gate keeping methodology was used|Least squares mean (SE)|||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.|
1650213|NCT01706536|3036397|Superiority||Least Squares Mean (SE)|0.1168|Standard Error of the Mean|0.04055|<|0.0043|2-Sided|95.0|0.0369|0.1966|||Least squares mean (SE)|In order to control for Type I error rate, a gate keeping methodology was used.||A sample size of 45 subjects per treatment arm provides approximately 80% power to detect a 0.12 L treatment difference in mean change in trough FEV1 between an active arm and the placebo arm at a significance level of 0.05 using a 2-group t-test and assumes a standard deviation for change in trough FEV1 of 200. Assuming a 20% discontinuation rate, approximately 55 subjects were enrolled into each treatment arm.|
1650214|NCT01706328|3036415|Superiority or Other||Mean Difference (Net)|0.025||||0.137|2-Sided|95.0|-0.008|0.059|||ANCOVA||||
1650215|NCT01706250|3036422|Superiority or Other||Mean Difference (Net)|0.17|Standard Deviation|0.86||0.625||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)|
1650216|NCT01706250|3036422|Superiority or Other||Mean Difference (Net)|0.17|Standard Deviation|0.62||0.4531||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)|
1650217|NCT01706250|3036422|Superiority or Other||Signed Rank|0.11|Standard Deviation|0.57||0.75||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)|
1650218|NCT01706250|3036422|Superiority or Other||Signed Rank|0.15|Standard Deviation|0.59||0.5||95.0|||||Signed Rank|||Change, in Scaling for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)|
1650219|NCT01706250|3036423|Superiority or Other||Mean Difference (Net)|0.17|Standard Deviation|0.38||0.25||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)|
1650220|NCT01706250|3036423|Superiority or Other||Mean Difference (Net)|0.28|Standard Deviation|0.75||0.25||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)|
1650221|NCT01706250|3036423|Superiority or Other||Mean Difference (Net)|0.32|Standard Deviation|0.58||0.0625||95.0|||||Signed Rank|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)|
1650222|NCT01706250|3036423|Superiority or Other||Median Difference (Net)|0.0|Standard Deviation|0.46||1||95.0|||||[Signed Rank]|||Change, in Itching for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)|
1651058|NCT01690273|3038182|Superiority or Other|||||||0.889|||||||Mixed Models Analysis||||
1650226|NCT01706250|3036424|Superiority or Other||Mean Difference (Net)|0.2|Standard Deviation|1.32||0.6172|||||||Signed Rank|||Change, in Burning for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)|
1650227|NCT01706250|3036425|Superiority or Other||Mean Difference (Net)|0.22|Standard Deviation|0.73||0.3594||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)|
1650228|NCT01706250|3036425|Superiority or Other||Mean Difference (Net)|0.28|Standard Deviation|0.75||0.2344||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)|
1650229|NCT01706250|3036425|Superiority or Other||Mean Difference (Net)|0.37|Standard Deviation|1.16||0.2656||95.0|||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)|
1650230|NCT01706250|3036425|Superiority or Other||Mean Difference (Net)|0.3|Standard Deviation|0.86||0.2131|||||||Signed Rank)|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)|
1650231|NCT01706250|3036426|Superiority or Other||Mean Difference (Net)|0.33|Standard Deviation|0.84||0.25|||||||Signed rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)|
1650232|NCT01706250|3036426|Superiority or Other||Mean Difference (Net)|0.17|Standard Deviation|0.86||0.75|||||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)|
1650233|NCT01706250|3036426|Superiority or Other||Median Difference (Net)|0.16|Standard Deviation|0.6||0.5||95.0|||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)|
1650234|NCT01706250|3036426|Superiority or Other||Mean Difference (Net)|0.15|Standard Deviation|0.67||0.5313||95.0|||||Signed Rank|||Change, in Redness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)|
1650235|NCT01706250|3036427|Superiority or Other||Mean Difference (Net)|-0.11|Standard Deviation|0.46||1|||||||Signed rank|||Change, in Peeling, for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)|
1650236|NCT01706250|3036428|Superiority or Other||Mean Difference (Net)|0.05|Standard Deviation|0.23||1|||||||Signed rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)|
1650237|NCT01706250|3036428|Superiority or Other||Mean Difference (Net)|0.05|Standard Deviation|0.22||1|||||||Signed Rank|||Change, in Dryness for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)|
1650238|NCT01706250|3036429|Superiority or Other||Signed Rank|0.05|Standard Deviation|0.23||1|||||||Signed Rank|||Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)|
1650239|NCT01706250|3036429|Superiority or Other||Mean Difference (Net)|0.1|Standard Deviation|0.45||1|||||||Signed Rank|||Change, in Erythema for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)|
1650240|NCT01706250|3036430|Superiority or Other||Mean Difference (Net)|0.0|Standard Deviation|0.59||1|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 8 (within group)|
1650241|NCT01706250|3036430|Superiority or Other||Mean Difference (Net)|-0.11|Standard Deviation|0.46||0.625|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 4 (within group)|
1650242|NCT01706250|3036430|Superiority or Other||Mean Difference (Net)|-0.26|Standard Deviation|0.56||0.125|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 2 (within group)|
1650243|NCT01706250|3036430|Superiority or Other||Mean Difference (Net)|-0.05|Standard Deviation|0.39||1|||||||Signed Rank|||Change, in ISGA for MAXCLARITY II Vs PROACTIV: from BL to Wk 1 (within group)|
1650244|NCT01706250|3036431|Superiority or Other||Mean Difference (Net)|7.0|Standard Deviation|25.4||0.2455|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 4 (within group)|
1650245|NCT01706250|3036431|Superiority or Other||Mean Difference (Net)|-5.75|Standard Deviation|29.61||0.4087|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 2 (within group)|
1650246|NCT01706250|3036431|Superiority or Other||Mean Difference (Net)|2.02|Standard Deviation|29.53||0.7634|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: TL count, BL to Wk 1 (within group)|
1650247|NCT01706250|3036432|Superiority or Other||Mean Difference (Final Values)|7.5|Standard Deviation|36.11||0.3774|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 4 (within group)|
1650248|NCT01706250|3036432|Superiority or Other||Mean Difference (Net)|-3.04|Standard Deviation|37.77||0.7296|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 2 (within group)|
1650249|NCT01706250|3036432|Superiority or Other||Mean Difference (Net)|3.2|Standard Deviation|42.31||0.7385|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: NIL count, BL to Wk 1 (within group)|
1650250|NCT01706250|3036433|Superiority or Other||Median Difference (Net)|23.64|Standard Deviation|52.05||0.0632|||||||t-test, 2 sided|||Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 4 (within group)|
1650251|NCT01706250|3036433|Superiority or Other||Median Difference (Net)|-4.0|Standard Deviation|39.91||0.6671|||||||t-test, 2 sided|||IL count for MAXCLARITY II Vs PROACTIV- BL to Wk 2 (within group)|
1650252|NCT01706250|3036433|Superiority or Other||Mean Difference (Net)|2.38|Standard Deviation|50.1||0.9909|||||||Signed Rank|||Percent change for MAXCLARITY II Vs PROACTIV: IL count, BL to Wk 1 (within group)|
1650253|NCT01706250|3036434|Superiority or Other||Median Difference (Net)|2.24|Standard Deviation|23.35||0.6894|||||||t-test, 2 sided|||Percent change for TL count for MAXCLARITY II Vs PROACTIV at Wk 8|
1650254|NCT01706250|3036434|Superiority or Other||Median Difference (Net)|7.68|Standard Deviation|29.51||0.2847|||||||t-test, 2 sided|||Percent change for NIL count for MAXCLARITY II Vs PROACTIV at Wk 8|
1650255|NCT01706250|3036434|Superiority or Other||Mean Difference (Net)|-3.29|Standard Deviation|32.98||0.6779|||||||t-test, 2 sided|||Percent change for IL count for MAXCLARITY II Vs PROACTIV at Wk 8|
1650256|NCT01706198|3036438|Other||Hazard Ratio (HR)|1.45||||0.255|2-Sided|95.0|0.77|2.74||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates.|Cox proportional hazards model||Hazard ratio for FF/VI versus Usual Care has been presented.||
1650299|NCT01705977|3036478|Other||Difference in percentage versus placebo|-0.7|||||2-Sided|95.0|-1.6|0.2|||||95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650257|NCT01706198|3036439|Non-Inferiority|Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.|Incidence ratio|1.4|||||2-Sided|95.0|0.8|2.7|||||Incidence ratio was calculated as percentage of participants who had at least one SAE of pneumonia in the FF/VI group divided by the percentage of participants who had at least one SAE of pneumonia in the Usual Care group.||
1650258|NCT01706198|3036440|Other||Adjusted Odds Ratio|1.51|||<|0.001|2-Sided|95.0|1.31|1.73||Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.|Regression, Logistic||Adjusted odds ratio of FF/VI versus Usual Care has been presented.||
1650259|NCT01706198|3036441|Other||Adjusted Odds Ratio|1.79|||<|0.001|2-Sided|95.0|1.55|2.06||Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.|Regression, Logistic||Adjusted odds ratio of FF/VI with Usual Care has been presented.||
1650260|NCT01706198|3036442|Other||Hazard Ratio (HR)|1.23|||<|0.001|2-Sided|95.0|1.09|1.38||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates|Cox proportional hazards model||Hazard ratio for FF/VI versus Usual Care has been presented||
1650261|NCT01706198|3036443|Other||Mean Difference (Final Values)|-0.8|||<|0.001|2-Sided|95.0|-1.1|-0.5||ANCOVA adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender,age & number of salbutamol inhalers in year prior to randomization|ANCOVA||Difference of FF/VI versus Usual Care has been presented.||
1650262|NCT01706198|3036444|Other||Hazard Ratio (HR)|0.96||||0.504|2-Sided|95.0|0.86|1.07||Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates|Cox proportional hazards model||A hazard ratio <1 indicated a lower risk with FF/VI compared with Usual Care||
1650263|NCT01706198|3036445|Other||Ratio|0.98||||0.697|2-Sided|95.0|0.88|1.09||GLM assuming NBD adjusted for randomized treatment; asthma maintenance therapy and ACT total score at Baseline per randomization stratification; number of severe asthma exacerbations in previous year prior to randomization categorized; gender & age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.||
1650264|NCT01706198|3036447|Other||Ratio|1.1|||<|0.001|2-Sided|95.0|1.05|1.15||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.||
1650265|NCT01706198|3036448|Other||Ratio|0.99||||0.822|2-Sided|95.0|0.91|1.08||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.||
1650266|NCT01706198|3036450|Other||Ratio|1.02||||0.461|2-Sided|95.0|0.97|1.08||GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.||
1650267|NCT01706198|3036451|Other||Ratio|1.03||||0.786|2-Sided|95.0|0.83|1.28||GLM assuming negative binomial distribution (NBD) adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age|Generalized Linear Model (GLM)||Ratio comparing FF/VI with Usual Care has been presented.||
1650268|NCT01706198|3036453|Other||Mean Difference (Net)|1.5|||<|0.001|2-Sided|95.0|1.24|1.76||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 52 has been presented.||
1650269|NCT01706198|3036453|Other||Mean Difference (Net)|1.37|||<|0.001|2-Sided|95.0|1.11|1.63||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 40 has been presented.||
1650270|NCT01706198|3036453|Other||Mean Difference (Net)|1.5|||<|0.001|2-Sided|95.0|1.25|1.76||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|MMRM||Treatment difference of FF/VI versus Usual Care at Week 24 has been presented.||
1650271|NCT01706198|3036453|Other||Mean Difference (Net)|1.54|||<|0.001|2-Sided|95.0|1.3|1.77||MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.|Mixed Model Repeated Measures (MMRM)||Treatment difference of FF/VI versus Usual Care at Week 12 has been presented.||
1650272|NCT01706198|3036454|Other||Adjusted Odds Ratio|1.91|||<|0.001|2-Sided|95.0|1.66|2.21||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.||
1650273|NCT01706198|3036454|Other||Adjusted Odds Ratio|1.76|||<|0.001|2-Sided|95.0|1.53|2.02||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.||
1650274|NCT01706198|3036454|Other||Adjusted Odds Ratio|2.09|||<|0.001|2-Sided|95.0|1.81|2.41||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.||
1650275|NCT01706198|3036454|Other||Adjusted Odds Ratio|2.28|||<|0.001|2-Sided|95.0|1.98|2.62||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.||
1650276|NCT01706198|3036455|Other||Adjusted Odds Ratio|1.95|||<|0.001|2-Sided|95.0|1.69|2.24||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.||
1650277|NCT01706198|3036455|Other||Adjusted Odds Ratio|1.79|||<|0.001|2-Sided|95.0|1.56|2.06||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.||
1650278|NCT01706198|3036455|Other||Adjusted Odds Ratio|1.96|||<|0.001|2-Sided|95.0|1.7|2.25||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.||
1650279|NCT01706198|3036455|Other||Adjusted Odds Ratio|2.09|||<|0.001|2-Sided|95.0|1.82|2.4||The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.||
1650280|NCT01706198|3036456|Other||Adjusted Odds Ratio|1.76|||<|0.001|2-Sided|95.0|1.54|2.02||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 52 has been presented.||
1650281|NCT01706198|3036456|Other||Adjusted Odds Ratio|1.66|||<|0.001|2-Sided|95.0|1.45|1.91||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 40 has been presented.||
1650282|NCT01706198|3036456|Other||Adjusted Odds Ratio|1.92|||<|0.001|2-Sided|95.0|1.67|2.2||Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care for Week 12 has been presented.||
1650283|NCT01706198|3036457|Other||Adjusted Odds Ratio|2.0|||<|0.001|2-Sided|95.0|1.7|2.34||The analysis method was logistic regression adjusted for randomized treatment, asthma maintenance therapy (AMT) at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.|Regression, Logistic||Adjusted odds ratio comparing FF/VI with Usual Care has been presented.||
1650284|NCT01706159|3036462|Superiority or Other||Odds Ratio (OR)|0.16||||0.3056||90.0|0.01|3.05||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||A sample size of 90 subjects, with a 2:1 (active:placebo) randomization ratio, would ensure 80% power to detect a difference between active treatment and placebo at Week 8 with a 2-sided significance level of 10% based on a Fisher’s exact test.|
1650285|NCT01705977|3036473|Other||Odds ratio versus placebo|1.3||||0.0284|2-Sided|95.0|1.03|1.65|||Regression, Logistic||95% CI and P-value was calculated from a logistic regression model for the comparison between belimumab and placebo including treatment group, Baseline prednisone dose, screening SELENA SLEDAI score (<=9 versus >=10) and region||
1650286|NCT01705977|3036475|Other||Difference in percentage versus placebo|0.3|||||2-Sided|95.0|-0.01|0.61|||||95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650287|NCT01705977|3036475|Other||Difference in percentage versus placebo|0.31|||||2-Sided|95.0|-0.42|1.05|||||95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650288|NCT01705977|3036475|Other||Difference in percentage versus placebo|0.3|||||2-Sided|95.0|0.02|0.58|||||95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650289|NCT01705977|3036475|Other||Difference in percentage versus placebo|0.05|||||2-Sided|95.0|-0.21|0.31|||||95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650290|NCT01705977|3036475|Other||Difference in percentage versus placebo|-0.1|||||2-Sided|95.0|-0.44|0.24|||||95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650291|NCT01705977|3036475|Other||Difference in percentage versus placebo|-1.0|||||2-Sided|95.0|-1.96|-0.04|||||95% CI for opportunistic infections and other infections of interest (serious and non-serious) was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650292|NCT01705977|3036475|Other||Difference in percentage versus placebo|-0.75|||||2-Sided|95.0|-2.02|0.51|||||95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650293|NCT01705977|3036476|Other||Difference in percentage versus placebo|-0.45|||||2-Sided|95.0|-1.03|0.13|||||95% CI was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650294|NCT01705977|3036478|Other||Difference in percentage versus placebo|0.3|||||2-Sided|95.0|-0.01|0.61|||||95% CI for SIHR was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650295|NCT01705977|3036478|Other||Difference in percentage versus placebo|0.26|||||2-Sided|95.0|-0.44|0.96|||||95% CI for suicidality (C-SSRS) was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650296|NCT01705977|3036478|Other||Difference in percentage versus placebo|0.3|||||2-Sided|95.0|0.02|0.58|||||95% CI for psychiatric events suggesting serious mood disorders and anxiety (serious depression) was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650297|NCT01705977|3036478|Other||Difference in percentage versus placebo|0.05|||||2-Sided|95.0|-0.21|0.31|||||95% CI for NMSC was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650298|NCT01705977|3036478|Other||Difference in percentage versus placebo|0.0|||||2-Sided|95.0|-0.31|0.31|||||95% CI for malignancies (excluding NMSC) was calculated using simple asymptotic Chi-Square (Pearson) method.||
1651059|NCT01690273|3038182|Superiority or Other|||||||0|||||||Mixed Models Analysis||||
1650300|NCT01705977|3036478|Other||Difference in percentage versus placebo|-0.35|||||2-Sided|95.0|-1.55|0.85|||||95% CI for serious infections was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650301|NCT01705977|3036479|Other||Difference in percentage versus placebo|0.1|||||2-Sided|95.0|-0.31|0.51|||||95% Confidence Interval was calculated using simple asymptotic Chi-Square (Pearson) method.||
1650302|NCT01705717|3036516|Superiority or Other|||||||0.007|||||||Chi-squared||||
1650303|NCT01705717|3036517|Superiority or Other|||||||0.034|||||||Chi-squared||||
1650304|NCT01705574|3036539|Superiority or Other (legacy)||Difference in proportions|6.5||||0.034|2-Sided|95.2|0.4|12.6|||Cochran-Mantel-Haenszel|P-value comparing virologic success was from the CMH test stratified by baseline HIV-1 RNA and race strata.|Difference in percentages of virologic success and its 95.2% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted MH proportion. If the lower bound of the CI was > 0, superiority of STB over ATV+RTV+TVD was established.|If noninferiority of STB versus ATV+RTV+TVD was established, the same 95.2% CI used in evaluating noninferiority was used to evaluate superiority. The baseline HIV-1 RNA and race stratum-stratified, 2-sided CMH test was also used to assess superiority as a secondary assessment.|
1650305|NCT01705574|3036539|Non-Inferiority or Equivalence (legacy)|The null hypothesis was that the STB group was at least 12% worse than the ATV+RTV+TVD group with respect to the percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 (response rate as defined by the snapshot analysis algorithm). The alternative hypothesis was that the STB group was less than 12% worse than the ATV+RTV+TVD group.|Difference in proportions|6.5|||||2-Sided|95.2|0.4|12.6|||||Difference in percentages of virologic success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel (MH) proportion.||
1650306|NCT01705288|3036548|Superiority|||||||0.18|||||||Wilcoxon (Mann-Whitney)||||
1650307|NCT01705288|3036549|Superiority|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Intention to Treat Analysis|
1650308|NCT01705288|3036550|Superiority|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||Intention to Treat Analysis|
1650309|NCT01704976|3036596|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1650310|NCT01704976|3036597|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1650311|NCT01704976|3036598|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1650312|NCT01704976|3036599|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1650313|NCT01704976|3036600|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1650314|NCT01704846|3036601|Non-Inferiority or Equivalence|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.2|||||2-Sided|90.0|98.1|102.34|||||Ratio calculated as Test product divided by reference product||
1650315|NCT01704846|3036602|Non-Inferiority or Equivalence|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|99.66|||||2-Sided|90.0|97.85|101.51|||||Ratio calculated as Test product divided by reference product||
1650316|NCT01704846|3036603|Non-Inferiority or Equivalence|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.34|||||2-Sided|90.0|98.51|102.2|||||Ratio calculated as Test product divided by reference product||
1650317|NCT01704846|3036604|Non-Inferiority or Equivalence|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the adjusted mean ratio was 80 to 125%.|Adjusted Mean Ratio (%)|97.66|||||2-Sided|90.0|91.54|103.78|||||Ratio calculated as Test product divided by reference product||
1650318|NCT01704846|3036605|Non-Inferiority or Equivalence|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.54|||||2-Sided|90.0|96.1|105.18|||||Ratio calculated as Test product divided by reference product||
1650319|NCT01704846|3036606|Non-Inferiority or Equivalence|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|102.99|||||2-Sided|90.0|95.57|110.98|||||Ratio calculated as Test product divided by reference product||
1650320|NCT01704846|3036607|Non-Inferiority or Equivalence|Assessment of bioequivalence between two different formulations of faldaprevir soft gelatine capsules in healthy male volunteers. The acceptance range for the geometric mean ratio was 80 to 125%.|Adjusted Geometric Mean Ratio (%)|100.47|||||2-Sided|90.0|95.9|105.25|||||Ratio calculated as Test product divided by reference product||
1650321|NCT01704755|3036617|Superiority or Other|||||||0.051|||||||Regression, Logistic|||To test the hypothesis that the percentages of participants who achieved sustained virologic response 12 weeks after treatment was different between the two treatment groups, the percentages were compared using a logistic regression model with treatment group, baseline log(subscript)10(subscript) HCV RNA level, HCV subgenotype (1a, non-1a), IL28B genotype (CC, non CC), and peginterferon-ribavirin treatment history (treatment-naïve or treatment-experienced) as predictors.|
1650322|NCT01704755|3036618|Non-Inferiority or Equivalence|The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.|Percentage of Participants|96.5|||||2-Sided|97.5|93.4|99.7|||||||
1650323|NCT01704755|3036618|Non-Inferiority or Equivalence|The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.|Percentage of Participants|96.5|||||2-Sided|97.5|93.4|99.7|||||||
1651060|NCT01690273|3038182|Superiority or Other|||||||0.016|||||||Mixed Models Analysis||||
1650324|NCT01704755|3036618|Non-Inferiority or Equivalence|The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.|Percentage of Participants|91.8|||||2-Sided|97.5|87.6|96.1||||||The primary efficacy endpoints were the SVR12 rates in each arm. The overall 2-sided significance level of 0.05 was split between the arms using a Bonferroni correction of 0.025. A 2-sided 97.5% CI of the SVR12 rate per arm was computed using the normal approximation to the binomial distribution. A gatekeeping testing procedure was used to control the Type I error rate at 0.05, and the primary endpoints for Arm A were tested separately from Arm B in a pre-specified order.|
1650325|NCT01704755|3036618|Non-Inferiority or Equivalence|The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.|Percentage of Participants|91.8|||||2-Sided|97.5|87.6|96.1||||||The study planned to enroll 380 subjects to a 12- or 24-week treatment arm. The primary efficacy endpoint (SVR12) was assessed for each arm. With a total sample size of 380 and assuming that 68% of the subjects in each arm would achieve SVR12, the study had greater than 90% power to demonstrate non-inferiority and superiority with a 2-sided 97.5% lower confidence bound greater than 43% and 54%, respectively, based on the normal approximation of a single binomial proportion.|
1650326|NCT01704651|3036619|Superiority or Other|||||||0.17|||||||t-test, 2 sided||||
1650327|NCT01704651|3036620|Superiority or Other|||||||0.34|||||||t-test, 2 sided||||
1650328|NCT01704495|3036687|Superiority or Other||Risk Ratio (RR)|1.29||||0.397|2-Sided|90.0|0.79|2.11||2-sided|Poisson Regression|Correction for overdispersion made by Pearson chi-square|AZD5069 5 mg BID vs Placebo||
1650329|NCT01704495|3036687|Superiority or Other||Risk Ratio (RR)|1.53||||0.141|2-Sided|90.0|0.95|2.46||2-sided|Poisson Regression|Correction for overdispersion made by Pearson chi-square|AZD5069 15 mg BID vs Placebo||
1650330|NCT01704495|3036687|Superiority or Other||Risk Ratio (RR)|1.56||||0.119|2-Sided|90.0|0.98|2.49||2-sided p-value|Poisson regression|Correction for overdispersion made by Pearson chi-square|AZD5069 45 mg BID vs Placebo||
1650331|NCT01704287|3036706|Superiority or Other (legacy)|PD-L1 Negative Participants|Hazard Ratio (HR)|0.71||||0.1504|2-Sided|95.0|0.44|1.13||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|
1650332|NCT01704287|3036706|Superiority or Other (legacy)|PD-L1 Negative Participants|Hazard Ratio (HR)|0.62||||0.0335|2-Sided|95.0|0.37|1.04||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|
1650333|NCT01704287|3036706|Superiority or Other (legacy)|PD-L1 Negative Participants|Hazard Ratio (HR)|1.07||||0.6043|2-Sided|95.0|0.65|1.76||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|
1650334|NCT01704287|3036706|Superiority or Other (legacy)|PD-L1 Positive Participants|Hazard Ratio (HR)|0.71||||0.0496|2-Sided|95.0|0.5|1.0||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|
1650335|NCT01704287|3036706|Superiority or Other (legacy)|PD-L1 Positive Participants|Hazard Ratio (HR)|0.7||||0.0208|2-Sided|95.0|0.5|0.99||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|
1650336|NCT01704287|3036706|Superiority or Other (legacy)|PD-L1-Positive Participants|Hazard Ratio (HR)|0.92||||0.3113|2-Sided|95.0|0.66|1.28||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|
1650337|NCT01704287|3036707|Superiority or Other (legacy)||Hazard Ratio (HR)|0.84||||0.149|2-Sided|95.0|0.66|1.07||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|
1650338|NCT01704287|3036707|Superiority or Other (legacy)||Hazard Ratio (HR)|0.71||||0.0023|2-Sided|95.0|0.55|0.9||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|
1650339|NCT01704287|3036707|Superiority or Other (legacy)||Hazard Ratio (HR)|0.86||||0.1146|2-Sided|95.0|0.68|1.1||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|
1650340|NCT01704287|3036708|Superiority or Other (legacy)||Hazard Ratio (HR)|0.87||||0.2905|2-Sided|95.0|0.67|1.12||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|
1650341|NCT01704287|3036708|Superiority or Other (legacy)||Hazard Ratio (HR)|0.74||||0.0106|2-Sided|95.0|0.57|0.96||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|
1650342|NCT01704287|3036708|Superiority or Other (legacy)||Hazard Ratio (HR)|0.86||||0.1173|2-Sided|95.0|0.67|1.1||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|
1650343|NCT01704287|3036709|Superiority or Other (legacy)|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.83||||0.1247|2-Sided|95.0|0.66|1.05||Two-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=Pembrolizumab 2 mg/kg||
1650344|NCT01704287|3036709|Superiority or Other (legacy)|Cox regression model with treatment as covariate stratified by ECOG performance status (0 vs. 1); LDH levels (normal vs. elevated LDH levels [≥110% ULN]); & BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.47|||<|0.0001|2-Sided|95.0|0.37|0.6||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 10 mg/kg Denominator=ICC||
1650345|NCT01704287|3036709|Superiority or Other (legacy)|Cox regression model with treatment as covariate stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1); lactate dehydrogenase (LDH) levels (normal vs. elevated LDH levels [≥110% Upper Limit of Normal (ULN)]); & BRAF mutational status (mutant vs. wild-type)|Hazard Ratio (HR)|0.58|||<|0.0001|2-Sided|95.0|0.46|0.73||One-sided p-value based on stratified log rank test|Log Rank||Numerator=Pembrolizumab 2 mg/kg Denominator=ICC||
1650346|NCT01704261|3036710|Superiority or Other||Between-group Rate Difference (%)|8.0||||0.005|2-Sided|95.0|2.7|14.5|||Miettinen & Nurminen method|Between-group confidence intervals and p-value (%) A1C <7.0%; estimated using standard multiple imputation techniques.|||
1650347|NCT01704261|3036710|Superiority or Other||Between-group Rate Difference|19.3|||<|0.001|2-Sided|95.0|11.7|27.6|||Miettinen & Nurminen method|Between-group confidence intervals and p-value (%) A1C <7.0%; estimated using standard multiple imputation techniques.|||
1650348|NCT01704261|3036711|Superiority or Other||Difference of the least squares means|-16.6|||<|0.001|2-Sided|95.0|-25.5|-7.8|||Difference in the least squares means|Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.|||
1650349|NCT01704261|3036712|Superiority or Other||Difference in % Omarigliptin vs Placebo|0.0|||||2-Sided|95.0|-4.3|4.3|||||||
1650350|NCT01704261|3036713|Superiority or Other||Difference in % Omarigliptin vs Placebo|9.8|||||2-Sided|95.0|-1.4|20.8|||||||
1650351|NCT01704261|3036714|Superiority or Other||Mean Difference (Final Values)|-0.61|||<|0.001|2-Sided|95.0|-0.85|-0.38|||Difference in the least squares means|Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.|||
1650352|NCT01704079|3036717|Superiority or Other (legacy)||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1650353|NCT01704079|3036718|Superiority or Other (legacy)||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1650354|NCT01704079|3036719|Superiority or Other (legacy)||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1650355|NCT01704079|3036720|Superiority or Other (legacy)||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1650356|NCT01703858|3036727|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|97.41|Standard Deviation|15.8||0.002|2-Sided|90.0|88.066|107.741|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect|
1650357|NCT01703858|3036727|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|117.16|Standard Deviation|16.6||0.1584|2-Sided|90.0|104.958|130.787|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect|
1650358|NCT01703858|3036727|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|83.46|Standard Deviation|18.7||0.2771|2-Sided|90.0|73.774|94.412|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect|
1650359|NCT01703858|3036727|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|70.24|Standard Deviation|18.3||0.9635|2-Sided|90.0|62.43|79.038|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect|
1650593|NCT01700140|3037269|Superiority or Other|||||||0.206|||||||Fisher Exact|||Statistical analysis for complete response rate after the third irradiation|
1650360|NCT01703858|3036727|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|98.66|Standard Deviation|9.9||0|2-Sided|90.0|92.5|105.225|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution|
1650361|NCT01703858|3036728|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|81.06|Standard Deviation|33.3||0.4564|2-Sided|90.0|65.811|99.848|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect|
1650362|NCT01703858|3036728|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|169.46|Standard Deviation|49.7||0.9463|2-Sided|90.0|124.093|231.419|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect|
1650363|NCT01703858|3036728|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|94.88|Standard Deviation|43.2||0.1449|2-Sided|90.0|72.175|124.731|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect|
1650364|NCT01703858|3036728|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|54.57|Standard Deviation|47.4||0.9808|2-Sided|90.0|40.711|73.157|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect|
1650365|NCT01703858|3036728|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|89.26|Standard Deviation|25.3||0.1261|2-Sided|90.0|75.893|104.973|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution|
1650366|NCT01703858|3036729|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|97.4|Standard Deviation|15.8||0.002|2-Sided|90.0|88.072|107.719|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|D : BI-113608 vs. B : BI-113608 - Pantoprazole effect|
1650367|NCT01703858|3036729|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|117.18|Standard Deviation|16.7||0.1599|2-Sided|90.0|104.923|130.867|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. C : BI-113608 - Food effect|
1650368|NCT01703858|3036729|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|83.36|Standard Deviation|18.8||0.2835|2-Sided|90.0|73.648|94.346|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|E : BI-113608 vs. B : BI-113608 - Food effect|
1650369|NCT01703858|3036729|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|70.16|Standard Deviation|18.3||0.9644|2-Sided|90.0|62.331|78.962|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|C : BI-113608 vs. B : BI-113608 - Food effect|
1650370|NCT01703858|3036729|Non-Inferiority or Equivalence|Assessment of bioequivalence was based upon 2-sided 90% confidence intervals (CIs) for the ratio of the geometric means (gMeans) with acceptance range of 80.00 to 125.00%|Ratio of Geometric means (%)|98.68|Standard Deviation|10.0||0|2-Sided|90.0|92.501|105.272|||ANOVA|Relative bioavailability was estimated by the ratios of the adjusted geometric means. CIs were calculated based on the residual error.|Analysis of variance includes the effects: sequence, subjects nested within sequences, period and treatment in crossover; subject and treatment in fixed sequence. Standard deviation is actually Intra individual geometric coefficient of variation.|B : BI-113608 vs. A : BI-113608 - Comparison with oral solution|
1650371|NCT01703832|3036757|Superiority or Other|||||||0.5153||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.|
1650372|NCT01703832|3036758|Superiority or Other|||||||0.1233||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.|
1650373|NCT01703819|3036770|Superiority or Other|||||||0.5702||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOV As.|
1650374|NCT01703819|3036771|Superiority or Other|||||||0.7726||||||Threshold less than or equal to 0.05. The final analysis demonstrated reasonable doubt of the implicit normality assumption of the two sets of AUC data, thus medians presented for efficacy analysis. Need for further investigation (ex-post analyses).|ANCOVA|||The null-hypotheses of no treatment differences were tested by the two-sided t-tests from the respective ANCOVAs.|
1650375|NCT01703702|3036785|Superiority or Other||Odds Ratio (OR)|1.45||||0.046|2-Sided|95.0|1.01|2.08|||Chi-squared|||Specialist Referral|
1650376|NCT01703702|3036785|Superiority or Other||Odds Ratio (OR)|1.08||||0.741|2-Sided|95.0|0.69|1.7|||Chi-squared|||Physician Follow-up for Re-evaluation|
1650377|NCT01703702|3036785|Superiority or Other||Odds Ratio (OR)|1.6||||0.063|2-Sided|95.0|0.97|2.64|||Chi-squared|||Neuropsychological Tests|
1650378|NCT01703702|3036785|Superiority or Other||Odds Ratio (OR)|1.96|||<|0.001|2-Sided|95.0|1.36|2.81|||Chi-squared|||Alzheimer's/Cognitive Medication|
1650379|NCT01703702|3036785|Superiority or Other||Odds Ratio (OR)|1.04|||<|0.857|2-Sided|95.0|0.7|1.54|||Chi-squared|||Major Diagnostic Tests|
1650380|NCT01703702|3036786|Superiority or Other||LS Mean Difference|0.16||||0.925|2-Sided|95.0|-3.2|3.53|||ANCOVA|Adjusted for: Baseline scale, Cognitive status (mild impairment/dementia), country and florbetapir F18 PET scan result (Aß+/Aß-).|||
1650381|NCT01703702|3036787|Superiority or Other||Odds Ratio (OR)|1.28||||0.144|2-Sided|95.0|0.92|1.78|||Chi-squared||||
1650382|NCT01703702|3036788|Superiority or Other||LS Mean Difference|20.69|||<|0.001|2-Sided|95.0|18.95|22.43|||ANCOVA|Adjusted for: Cognitive status (mild impairment/dementia), physician/practice type, country and florbetapir F18 PET scan result (Aß+/Aß-)||Comparison of change in diagnostic confidence at follow-up (3 months)|
1650383|NCT01703702|3036789|Superiority or Other||Odds Ratio (OR)|43.9|||<|0.001|2-Sided|95.0|20.0|96.12|||Chi-squared||||
1650384|NCT01703702|3036790|Superiority or Other||LS Mean Difference|-0.35||||0.568|2-Sided|95.0|-1.54|0.84|||ANCOVA|Adjusted for: Baseline ADAS-Cog score, study arm, Alzheimer's treatment, country, and interaction between study arm and Alzheimer's treatment.|||
1650385|NCT01703702|3036791|Superiority or Other||Odds Ratio (OR)|1.7||||0.002|2-Sided|95.0|1.22|2.38|||Chi-squared||||
1650386|NCT01703663|3036792|Superiority or Other||absolute difference|-5.73||||0.183|2-Sided|95.0|-14.4|2.97|||ANOVA||||
1650387|NCT01703286|3036801|Superiority or Other||Mean Difference (Net)|0.072|Standard Error of the Mean|0.048||0.1412|2-Sided|90.0|-0.009|0.152|||ANOVA||||
1650388|NCT01703286|3036801|Superiority or Other||Mean Difference (Net)|0.021|Standard Error of the Mean|0.048||0.6601|2-Sided|90.0|-0.059|0.101|||ANOVA||||
1650389|NCT01703286|3036801|Superiority or Other||Mean Difference (Net)|-0.05|Standard Error of the Mean|0.048||0.2982|2-Sided|90.0|-0.13|0.03|||ANOVA||||
1650390|NCT01703286|3036802|Superiority or Other||Geometric mean ratio (net)|1.035||||0.8749|2-Sided|90.0|0.721|1.485|||ANOVA||||
1650391|NCT01703286|3036802|Superiority or Other||Geometric mean ratio (net)|1.251||||0.3105|2-Sided|90.0|0.868|1.801|||ANOVA||||
1650392|NCT01703286|3036802|Superiority or Other||Geometric mean ratio (net)|1.208||||0.3885|2-Sided|90.0|0.84|1.738|||ANOVA||||
1650393|NCT01703286|3036803|Superiority or Other||Geometric mean ratio (net)|1.0||||0.9989|2-Sided|90.0|0.715|1.397|||ANOVA||||
1650394|NCT01703286|3036803|Superiority or Other||Geometric mean ratio (net)|0.884||||0.5402|2-Sided|90.0|0.632|1.235|||ANOVA||||
1650395|NCT01703286|3036803|Superiority or Other||Geometric mean ratio (net)|0.884||||0.5403|2-Sided|90.0|0.633|1.235|||ANOVA||||
1650396|NCT01703221|3036810|Superiority or Other (legacy)||Difference in the least squares means|2.23||||0.33|2-Sided|95.0|-2.27|6.73|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.|||
1650397|NCT01703221|3036810|Superiority or Other (legacy)||Difference in the least squares means|-14.51|||<|0.001|2-Sided|95.0|-20.04|-8.98|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.|||
1650398|NCT01703221|3036810|Superiority or Other (legacy)||Difference in the least squares means|-12.28|||<|0.001|2-Sided|95.0|-17.78|-6.78|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.|||
1650594|NCT01700140|3037269|Superiority or Other|||||||0.3513|||||||Fisher Exact|||Statistical analysis for complete response rate after the second irradiation|
1650399|NCT01703221|3036811|Superiority or Other (legacy)||Difference in the least squares means|2.86||||0.555|2-Sided|95.0|-6.67|12.39|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.|||
1650400|NCT01703221|3036811|Superiority or Other (legacy)||Difference in the least squares means|-39.76|||<|0.001|2-Sided|95.0|-51.28|-28.23|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.|||
1650401|NCT01703221|3036811|Superiority or Other (legacy)||Difference in the least squares means|-36.89|||<|0.001|2-Sided|95.0|-48.46|-25.33|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.|||
1650402|NCT01703221|3036816|Non-Inferiority or Equivalence (legacy)|Omarigliptin will be considered non-inferior to sitagliptin if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in least squares means for change from baseline in HbA1c at Week 24 (omarigliptin minus sitagliptin) is not more than 0.3% (non-inferiority margin).|Difference in the least squares means|-0.02||||0.792|2-Sided|95.0|-0.15|0.12|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.|||
1650403|NCT01703221|3036816|Superiority or Other (legacy)||Difference in the least squares means|-0.78|||<|0.001|2-Sided|95.0|-0.94|-0.61|||Constrained longitudinal analysis|Terms for treatment, prior AHA therapy status (yes/no), time, and time by: treatment, prior AHA therapy status, and treatment by prior AHA status.|||
1650404|NCT01703221|3036816|Superiority or Other (legacy)||Difference in the least squares means|-0.8|||<|0.001|2-Sided|95.0|-0.96|-0.63|||Constrained longitudinal analysis|Terms for treatment, prior oral antihyperglycemic agent (AHA), time, time by: treatment, prior AHA therapy status, and treatment by prior AHA status.|||
1650405|NCT01703208|3036817|Superiority or Other||Hazard Ratio (HR)|0.6|||||2-Sided|95.0|0.35|1.05|||||Based on the proportional hazards model that includes treatment as an explanatory factor.||
1650406|NCT01703208|3036819|Superiority or Other||Between group rate difference|11.9|||<|0.001|2-Sided|95.0|6.9|16.8||Estimated using standard multiple imputation techniques.|Miettinen & Nurminen method||||
1650407|NCT01703208|3036820|Superiority or Other||Difference in the least squares means|-3.1||||0.421|2-Sided|95.0|-10.8|4.5|||Longitudinal constrained data analysis||Based on a LDA model including terms for treatment, time and the interaction of time by treatment.||
1650408|NCT01703208|3036826|Superiority or Other||Difference in the Least Squares Means|-0.3|||||2-Sided|95.0|-0.46|-0.14|||||Longitudinal Data Analysis (LDA) model including terms for treatment, time, and the interaction of time by treatment.||
1650409|NCT01703208|3036827|Superiority or Other||Hazard Ratio (HR)|1.28|||||2-Sided|95.0|0.88|1.85|||||Based on the proportional hazards model that includes treatment as an explanatory factor.||
1650410|NCT01703208|3036829|Superiority or Other||Hazard Ratio (HR)|0.94|||||2-Sided|95.0|0.58|1.52|||||Based on the proportional hazards model that includes treatment as an explanatory factor.||
1650411|NCT01703208|3036831|Superiority or Other||Hazard Ratio (HR)|0.87|||||2-Sided|95.0|0.6|1.26|||||Based on the proportional hazards model that includes treatment as an explanatory factor.||
1650412|NCT01703208|3036833|Superiority or Other||Hazard Ratio (HR)|1.06|||||2-Sided|95.0|0.66|1.68|||||Based on the proportional hazards model that includes treatment as an explanatory factor.||
1650413|NCT01703208|3036835|Superiority or Other||Difference in Percentage vs. Placebo|0.3|||||2-Sided|95.0|-1.0|1.7|||||Based on Miettinen & Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.||
1650414|NCT01703208|3036836|Superiority or Other||Difference in Percent vs. Placebo|-1.1|||||2-Sided|95.0|-7.2|4.9|||||Based on Miettinen & Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.||
1650415|NCT01703208|3036837|Superiority or Other||Difference in the LS Means vs Placebo|-0.39|||<|0.001|2-Sided|95.0|-0.5|-0.27|||Longitudinal data analysis|Longitudinal data analysis model including terms for treatment, time and the interaction of time by treatment.|||
1650416|NCT01703208|3036838|Superiority or Other||Difference in the least squares means|-0.43|||||2-Sided|95.0|-0.48|-0.37|||||||
1650417|NCT01703208|3036839|Superiority or Other||Hazard Ratio (HR)|1.0|||||2-Sided|95.0|0.77|1.29|||||Based on the proportional hazards model that includes treatment as an explanatory factor.||
1650418|NCT01703169|3036846|Other||||||||||||||||||The proportion of platelet response in a previous study (PMID:22762314) was 0.36 (9/25). The null hypothesis of no difference between the platelet response rate in this study and that of the previous study was tested using a two-sided exact test of binomial proportions. A p-value of 0.40 was obtained. The threshold for significance was 0.05.
1650419|NCT01703039|3036858|Superiority|||||||0.04|||||||ANOVA||||
1650420|NCT01703039|3036859|Superiority|||||||0.27|||||||ANOVA||||
1650421|NCT01703039|3036860|Superiority|||||||0.34|||||||Chi-squared||||
1650422|NCT01703039|3036861|Superiority|||||||0.31|||||||Chi-squared||||
1650423|NCT01703039|3036862|Superiority|||||||0.06|||||||ANOVA||||
1650424|NCT01702558|3036932|Superiority||Difference in Response Rates|8.2||||0.336|2-Sided|90.0|-4.5|20.9|||Fisher Exact||90% CI was estimated using Hauck-Anderson approach.||
1650425|NCT01702532|3036936|Superiority or Other||LS Means Difference|-4.9||||0.0141|2-Sided|95.0|-8.8|-0.99||The comparison between treatments was conducted in a hierarchical order; consequently no adjustment of the significance level (5%) for multiplicity was needed.|ANCOVA|ANCOVA model contains pre-provocation baseline, pre-dosing post-provocation craving score, and the terms treatment groups and center as fixed|Comment: The confidence interval is for the difference between treatments groups|Null hypotheses considered change in craving score means from pre-dose post-provocation at 50 seconds to be equal for the two treatment groups.|
1650426|NCT01702519|3036941|Non-Inferiority or Equivalence|Bioequivalence was established if 90% confidence interval (CI) of the ratio (Test/Ref) of geometric means was included in the limit of 0.80 - 1.25.|Treatment Ratio|0.962|||||2-Sided|90.0|0.92|1.0|||||The ratio between the geometric means of the test and reference formulations was calculated|Null hypothesis considered no difference between the treatments.|
1650427|NCT01702519|3036942|Non-Inferiority or Equivalence|Bio-equivalence was established if 90% confidence interval (CI) of the ratio (Test/Ref) of geometric means was included in the limit of 0.80 - 1.25|Treatment Ratio|0.946|||||2-Sided|90.0|0.912|0.982|||||The ratio between the geometric means of the test and reference formulations was calculated|Null hypothesis considered no difference between the two treatments.|
1650428|NCT01702454|3036975|Non-Inferiority or Equivalence|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|56.72|||||2-Sided|95.0|49.41|63.49||||||"To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.~B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)"|
1650429|NCT01702454|3036975|Non-Inferiority or Equivalence|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion|Difference in SPR|56.68|||||2-Sided|95.0|49.44|63.43||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.|
1650430|NCT01702454|3036975|Non-Inferiority or Equivalence|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|47.4|||||2-Sided|95.0|39.08|55.06||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.|
1650431|NCT01702454|3036975|Non-Inferiority or Equivalence|SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in SPR|62.43|||||2-Sided|95.0|55.27|68.89||||||To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains|
1650432|NCT01702454|3036977|Non-Inferiority or Equivalence|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion|Difference in percentages|56.0||||||95.0|48.32|63.04||||||"To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.~B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)"|
1650433|NCT01702454|3036977|Non-Inferiority or Equivalence|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|37.86||||||95.0|28.83|46.26||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.|
1650434|NCT01702454|3036977|Non-Inferiority or Equivalence|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|45.31|||||2-Sided|95.0|36.58|53.3||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.|
1650435|NCT01702454|3036977|Non-Inferiority or Equivalence|SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.|Difference in percentages|44.74|||||2-Sided|95.0|35.87|52.84||||||To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.|
1650436|NCT01702454|3036979|Non-Inferiority or Equivalence|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|6.71|||||2-Sided|95.0|5.21|8.63|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for B/Hub-Wuj strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.|
1650437|NCT01702454|3036979|Non-Inferiority or Equivalence|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|3.94|||||2-Sided|95.0|2.89|5.37|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for B/Brisbane strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.|
1650438|NCT01702454|3036979|Non-Inferiority or Equivalence|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|2.7|||||2-Sided|95.0|1.81|4.02|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval|The adjusted GMT of HI antibodies for A/Victoria strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.|
1650439|NCT01702454|3036979|Non-Inferiority or Equivalence|Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1|Adjusted GMT ratio|8.97|||||2-Sided|95.0|6.21|12.96|||||The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.|The adjusted GMT of HI antibodies for A/Christchurch strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.|
1650440|NCT01702428|3036988|Non-Inferiority|The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.95|||||2-Sided|95.0|0.85|1.06||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 23F antibody at Day 42.|
1650595|NCT01700140|3037269|Superiority or Other|||||||0.6761|||||||Fisher Exact|||Statistical analysis for complete response rate after the second irradiation|
1650441|NCT01702428|3036988|Non-Inferiority|The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.96|||||2-Sided|95.0|0.87|1.06||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 19F antibody at Day 42.|
1650442|NCT01702428|3036988|Non-Inferiority|The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.97|||||2-Sided|95.0|0.87|1.07||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 19A antibody at Day 42.|
1650443|NCT01702428|3036988|Non-Inferiority|The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.92|||||2-Sided|95.0|0.84|1.02||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 18C antibody at Day 42.|
1650444|NCT01702428|3036988|Non-Inferiority|The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.91|||||2-Sided|95.0|0.81|1.02||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 14 antibody at Day 42.|
1650445|NCT01702428|3036988|Non-Inferiority|The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.99|||||2-Sided|95.0|0.9|1.08||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 9V antibody at Day 42.|
1650446|NCT01702428|3036988|Non-Inferiority|The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.94|||||2-Sided|95.0|0.86|1.03||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 7F antibody at Day 42.|
1650447|NCT01702428|3036988|Non-Inferiority|The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.98|||||2-Sided|95.0|0.89|1.09||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 6B antibody at Day 42.|
1650448|NCT01702428|3036988|Non-Inferiority|The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|1.01|||||2-Sided|95.0|0.92|1.11||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 6A antibody at Day 42.|
1650449|NCT01702428|3036988|Non-Inferiority|The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.92|||||2-Sided|95.0|0.83|1.01||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 5 antibody at Day 42.|
1650450|NCT01702428|3036988|Non-Inferiority|The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.88||||||95.0|0.79|0.98||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 4 antibody at Day 42.|
1650451|NCT01702428|3036988|Non-Inferiority|The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.99|||||2-Sided|95.0|0.91|1.08||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 3 antibody at Day 42.|
1650452|NCT01702428|3036988|Non-Inferiority|The LL of the 2-sided 95% CI for GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.5 for antibodies to for antibodies to PS serotypes.|Adjusted GMC ratio|0.94|||||2-Sided|95.0|0.85|1.05||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for anti-PnPS 1 antibody at Day 42.|
1650453|NCT01702428|3036989|Non-Inferiority|The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) was ≥0.5 for antibodies to HAV virus.|Adjusted GMC ratio|0.98|||||2-Sided|95.0|0.86|1.11||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to HAV virus at Day 42.|
1650454|NCT01702428|3036991|Non-Inferiority|The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.67 for antibodies to VZV.|Adjusted GMC ratio|1.01|||||2-Sided|95.0|0.95|1.08||||||In US sub-cohort: Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to VZV virus at Day 42.|
1650455|NCT01702428|3036992|Non-Inferiority|The LL of 2-sided 95 % CI for the difference in seroresponse (pooled INV_MMR Group minus pooled COM_MMR Group) should be ≥-10% for antibodies to VZV.|Difference in seroresponse rate|1.3|||||2-Sided|95.0|-1.31|4.29|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|In US sub-cohort: Difference in percentage (INV_MMR Group minus COM_MMR Group) of subjects with anti-VZV antibody concentration at Day 42.|
1650456|NCT01702428|3036993|Non-Inferiority|The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.67 for antibodies to measles virus.|Adjusted GMC ratio|0.87|||||2-Sided|95.0|0.83|0.92||||||Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to rubella virus at Day 42.|
1650457|NCT01702428|3036994|Non-Inferiority|The LL of 2-sided 95 % CI for the difference in seroresponse (INV_MMR Group minus COM_MMR Group) should be ≥-5% for antibodies to rubella virus.|Difference in seroresponse rate|-1.15|||||2-Sided|95.0|-2.0|-0.15|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV_MMR Group minus COM_MMR Group) of subjects with anti-rubella antibody concentration at Day 42.|
1650458|NCT01702428|3036995|Non-Inferiority|The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.67 for antibodies to mumps virus.|Adjusted GMC ratio|1.05|||||2-Sided|95.0|0.99|1.11||||||Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to mumps virus at Day 42.|
1650459|NCT01702428|3036996|Non-Inferiority|The LL of 2-sided 95 % CI for the difference in seroresponse (INV_MMR Group minus COM_MMR Group) should be ≥-5% for antibodies to mumps virus.|Difference in seroresponse rate|0.81|||||2-Sided|95.0|-0.1|1.96|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV_MMR Group minus COM_MMR Group) of subjects with anti-mumps antibody concentration at Day 42.|
1650460|NCT01702428|3036997|Non-Inferiority|The LL of the 2-sided 95% CI on GMC ratio (INV_MMR Group over COM_MMR Group) should be ≥0.67 for antibodies to measles virus.|Adjusted GMC ratio|0.98|||||2-Sided|95.0|0.93|1.05||||||Adjusted GMC ratio (INV_MMR Group divided by COM_MMR Group) for antibodies to measles virus at Day 42.|
1650461|NCT01702428|3036998|Non-Inferiority|The Lower Limit (LL) of 2-sided 95 % CI for the difference in seroresponse (INV_MMR Group minus COM_MMR Group) should be ≥-5% for antibodies to measles virus.|Difference in seroresponse rate|0.18|||||2-Sided|95.0|-0.68|1.25|||||Asymptotic standardized 95% CIs for the difference in seroresponse rate.|Difference in percentage (INV_MMR Group minus COM_MMR Group) of subjects with anti-measles antibody concentration at Day 42.|
1650462|NCT01702428|3036999|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.|Adjusted GMC ratio|1.08|||||2-Sided|95.0|1.01|1.15||||||Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L2 Group) for antibodies to rubella virus at Day 42.|
1650463|NCT01702428|3036999|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.|Adjusted GMC ratio|1.0|||||2-Sided|95.0|0.93|1.07||||||Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L1 Group) for antibodies to rubella virus at Day 42.|
1650464|NCT01702428|3036999|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.|Adjusted GMC ratio|0.93|||||2-Sided|95.0|0.87|0.99||||||Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L3 Group) for antibodies to rubella virus at Day 42.|
1650465|NCT01702428|3036999|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.|Adjusted GMC ratio|0.93|||||2-Sided|95.0|0.87|0.99||||||Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L1 Group) for antibodies to rubella virus at Day 42.|
1650466|NCT01702428|3036999|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.|Adjusted GMC ratio|1.0|||||2-Sided|95.0|0.94|1.07||||||Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L3 Group) for antibodies to rubella virus at Day 42.|
1650467|NCT01702428|3036999|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.|Adjusted GMC ratio|1.08|||||2-Sided|95.0|1.01|1.15||||||"Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L2 Group) for antibodies to rubella virus at Day 42.~."|
1650468|NCT01702428|3037000|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to rubella virus.|Difference in seroresponse rate|-0.62|||||2-Sided|95.0|-2.02|0.74|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV_MMR_L2 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.|
1650469|NCT01702428|3037000|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to rubella virus.|Difference in seroresponse rate|-0.49|||||2-Sided|95.0|-1.86|0.86|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV_MMR_L1 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.|
1650470|NCT01702428|3037000|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to rubella virus.|Difference in seroresponse rate|0.14|||||2-Sided|95.0|-1.3|1.58|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV_MMR_L1 Group minus INV_MMR_L2 Group) in percentage of subjects with anti-rubella antibody concentration ≥10 IU/mL.|
1650471|NCT01702428|3037001|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.|Adjusted GMC ratio|0.9|||||2-Sided|95.0|0.84|0.96||||||Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L2 Group) for antibodies to mumps virus at Day 42.|
1650472|NCT01702428|3037001|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.|Adjusted GMC ratio|0.96|||||2-Sided|95.0|0.9|1.03||||||Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L1 Group) for antibodies to mumps virus at Day 42.|
1650473|NCT01702428|3037001|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.|Adjusted GMC ratio|1.11|||||2-Sided|95.0|1.04|1.19||||||Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L3 Group) for antibodies to mumps virus at Day 42.|
1650474|NCT01702428|3037001|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.|Adjusted GMC ratio|1.07|||||2-Sided|95.0|1.0|1.15||||||Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L1 Group) for antibodies to mumps virus at Day 42.|
1650475|NCT01702428|3037001|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.|Adjusted GMC ratio|1.04|||||2-Sided|95.0|0.97|1.11||||||Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L3 Group) for antibodies to mumps virus at Day 42.|
1650476|NCT01702428|3037001|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to mumps.|Adjusted GMC ratio|0.93|||||2-Sided|95.0|0.87|1.0||||||Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L2 Group) for antibodies to mumps virus at Day 42.|
1650477|NCT01702428|3037002|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.61|||||2-Sided|95.0|-0.53|1.79|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV_MMR_L2 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.|
1650478|NCT01702428|3037002|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.63|||||2-Sided|95.0|-0.5|1.81|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV_MMR_L1 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.|
1650479|NCT01702428|3037002|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to mumps virus.|Difference in seroresponse rate|0.02|||||2-Sided|95.0|-1.05|1.09|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV_MMR_L1 Group minus INV_MMR_L2 Group) in percentage of subjects with anti-mumps antibody concentration ≥10 EU/mL.|
1650480|NCT01702428|3037003|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.|Adjusted GMC ratio|1.01|||||2-Sided|95.0|0.94|1.09||||||Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L2 Group) for antibodies to measles virus at Day 42.|
1650481|NCT01702428|3037003|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.|Adjusted GMC ratio|1.03|||||2-Sided|95.0|0.95|1.11||||||Adjusted GMC ratio (INV_MMR_L3 Group divided by INV_MMR_L1 Group) for antibodies to measles virus at Day 42.|
1650482|NCT01702428|3037003|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.|Adjusted GMC ratio|0.99|||||2-Sided|95.0|0.91|1.06||||||Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L3 Group) for antibodies to measles virus at Day 42.|
1650483|NCT01702428|3037003|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.|Adjusted GMC ratio|1.01|||||2-Sided|95.0|0.94|1.09||||||Adjusted GMC ratio (INV_MMR_L2 Group divided by INV_MMR_L1 Group) for antibodies to measles virus at Day 42.|
1650484|NCT01702428|3037003|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.|Adjusted GMC ratio|0.97|||||2-Sided|95.0|0.9|1.05||||||Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L3 Group) for antibodies to measles virus at Day 42.|
1650485|NCT01702428|3037003|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% CI on the lot ratio should be within the [0.67;1.5] margin for antibodies to measles.|Adjusted GMC ratio|0.99|||||2-Sided|95.0|0.91|1.06||||||Adjusted GMC ratio (INV_MMR_L1 Group divided by INV_MMR_L2 Group) for antibodies to measles virus at Day 42.|
1650486|NCT01702428|3037004|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to measles virus.|Difference in seroresponse rate|0.25|||||2-Sided|95.0|-0.98|1.5|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV_MMR_L1 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.|
1650487|NCT01702428|3037004|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to measles virus.|Difference in seroresponse rate|0.79|||||2-Sided|95.0|-0.35|1.98|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV_MMR_L2 Group minus INV_MMR_L3 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.|
1650488|NCT01702428|3037004|Non-Inferiority or Equivalence (legacy)|For each pair-wise comparison, the 2-sided 95% confidence interval (CI) on the lot difference in seroresponse rates should be within the [-5%;5%] margin for antibodies to measles virus.|Difference in seroresponse rate|-0.54|||||2-Sided|95.0|-1.69|0.58|||||Asymptotic standardized 95% CI for the pair-wise differences in seroresponse.|Difference between groups (INV_MMR_L1 Group minus INV_MMR_L2 Group) in percentage of subjects with anti-measles antibody concentration ≥200 mIU/mL.|
1650489|NCT01702259|3037039|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1650490|NCT01702259|3037040|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1650491|NCT01702259|3037041|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1650492|NCT01702259|3037042|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1650493|NCT01702246|3037043|Superiority or Other|||||||0.001|||||||t-test, 2 sided||||
1650494|NCT01702246|3037044|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1650495|NCT01702246|3037045|Superiority or Other|||||||0.005||||||Wilcoxon matched pairs signed rank test|Wilcoxon (Mann-Whitney)||||
1650496|NCT01702233|3037058|Non-Inferiority or Equivalence|All statistical analyses were of exploratory nature. A one-sided test of non-inferiority of Traumeel®S with respect to dexamethasone at level 0.025 was computed using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and the baseline value of the abduction rotation pain VAS for active external rotation as a covariate. The test decision was based on a one-sided 97.5% confidence interval . The non-inferiority margin was set to 13 mm on a 0-100 mm VAS scale.|Mean Difference (Final Values)|13.0|Standard Deviation|13.0|<|0.05|1-Sided|95.0||97.5|||ANCOVA||||
1650497|NCT01701401|3037096|Superiority or Other||||||<|0.001||||||The p-value for the comparison of the LDV/SOF+RBV 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test||||
1650498|NCT01701401|3037096|Superiority or Other||||||<|0.001||||||The p-value for the comparison of the LDV/SOF 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test||||
1650499|NCT01701401|3037096|Superiority or Other||||||<|0.001||||||The p-value for the comparison of the LDV/SOF+RBV 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test||||
1650500|NCT01701401|3037096|Superiority or Other||||||<|0.001||||||The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.|Binomial test||||
1650501|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|1.38||||0.1889||95.0|0.85|2.21|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 15|
1650502|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|1.66||||0.0314||95.0|1.05|2.64|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 14|
1650503|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|1.71||||0.0256||95.0|1.07|2.74|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 13|
1650504|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|2.03||||0.003||95.0|1.27|3.23|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 12|
1650505|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|1.77||||0.0176||95.0|1.1|2.84|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 11|
1650506|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|1.55||||0.0667||95.0|0.97|2.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 10|
1650507|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|1.65||||0.0364||95.0|1.03|2.63|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 9|
1650508|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|1.44||||0.1227||95.0|0.91|2.29|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 8|
1650509|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|1.68||||0.0349||95.0|1.04|2.73|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 7|
1650510|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|1.55||||0.0693||95.0|0.97|2.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 6|
1650511|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|1.86||||0.0137||95.0|1.14|3.05|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 5|
1650512|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|1.71||||0.0382||95.0|1.03|2.83|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 4|
1650513|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|2.2||||0.0039||95.0|1.29|3.77|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 3|
1650514|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|1.92||||0.0652||95.0|0.96|3.85|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 2|
1650515|NCT01701362|3037099|Superiority or Other||Odds Ratio (OR)|2.11||||0.1633||95.0|0.74|6.0|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 1|
1650516|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|0.96||||0.8464||95.0|0.61|1.49|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 15|
1650517|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|1.19||||0.4245||95.0|0.78|1.8|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 14|
1650518|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|1.16||||0.4908||95.0|0.76|1.76|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 13|
1650519|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|1.15||||0.5025||95.0|0.76|1.74|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 12|
1650520|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|1.09||||0.6854||95.0|0.72|1.64|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 11|
1650521|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|1.36||||0.1462||95.0|0.9|2.05|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 10|
1650522|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|1.19||||0.3947||95.0|0.79|1.8|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 9|
1650523|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|1.24||||0.3072||95.0|0.82|1.86|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 8|
1650524|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|1.37||||0.1313||95.0|0.91|2.06|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 7|
1650525|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|1.45||||0.0707||95.0|0.97|2.16|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 6|
1650526|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|1.46||||0.0677||95.0|0.97|2.2|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 5|
1650527|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|1.48||||0.0619||95.0|0.98|2.24|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 4|
1650528|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|1.62||||0.0235||95.0|1.07|2.45|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 3|
1650529|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|1.66||||0.036||95.0|1.03|2.68|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 2|
1650530|NCT01701362|3037100|Superiority or Other||Odds Ratio (OR)|3.2||||0.0028||95.0|1.5|6.86|||Gen linear model-logistic link function|Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.||Statistical analysis at Week 1|
1650531|NCT01701362|3037101|Superiority or Other|||||||0.7165||||||p-values based on CMH test stratified by pooled center and trauma type, patients with unknown status at baseline or endpoint will not be included in the calculation of p-values.|Cochran-Mantel-Haenszel||||
1650532|NCT01701362|3037102|Superiority or Other||leaet squares mean difference|-0.1|Standard Error of the Mean|0.04||0.0609||95.0|-0.15|0.0|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Optimal Sleep Score|
1650533|NCT01701362|3037102|Superiority or Other||least square mean difference|1.7|Standard Error of the Mean|1.45||0.249||95.0|-1.18|4.53|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Problem Index (9) Score|
1650534|NCT01701362|3037102|Superiority or Other||least square mean difference|-2.1|Standard Error of the Mean|1.5||0.1562||95.0|-5.08|0.82|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Somnolence Score|
1650535|NCT01701362|3037102|Superiority or Other||least square mean difference|-0.2|Standard Error of the Mean|0.15||0.2663||95.0|-0.45|0.12|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Quantity of Sleep Score (hours)|
1650536|NCT01701362|3037102|Superiority or Other||least square mean difference|0.6|Standard Error of the Mean|1.7||0.7317||95.0|-2.76|3.93|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Awaken Short of Breath Score|
1650537|NCT01701362|3037102|Superiority or Other||least square mean difference|-1.1|Standard Error of the Mean|2.04||0.6059||95.0|-5.06|2.96|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Snoring Score|
1650538|NCT01701362|3037102|Superiority or Other||least square mean difference|-2.0|Standard Error of the Mean|2.29||0.3913||95.0|-6.47|2.54|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Adequancy Score|
1650539|NCT01701362|3037102|Superiority or Other||least square mean difference|3.5|Standard Error of the Mean|1.8||0.0545||95.0|-0.07|7.0|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||Statistical analysis for Sleep Disturbance Score|
1650540|NCT01701362|3037104|Superiority or Other||leaset squares mean difference|-0.02|Standard Error of the Mean|0.026||0.5493||95.0|-0.07|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for Dolan 2001 Index Score|
1650541|NCT01701362|3037104|Superiority or Other||least squares mean difference|0.01|Standard Error of the Mean|0.017||0.5||95.0|-0.02|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for Dolan 1997 Index score|
1650542|NCT01701362|3037104|Superiority or Other||leaset squares mean difference|0.03|Standard Error of the Mean|0.037||0.4654||95.0|-0.05|0.1|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for anxiety/depression|
1650543|NCT01701362|3037104|Superiority or Other||least squares mean difference|-0.06|Standard Error of the Mean|0.043||0.1628||95.0|-0.14|0.02|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for pain/discomfort|
1650544|NCT01701362|3037104|Superiority or Other||least squares mean difference|0.01|Standard Error of the Mean|0.043||0.859||95.0|-0.08|0.09|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for usual activities|
1650545|NCT01701362|3037104|Superiority or Other||least squares mean difference|-0.01|Standard Error of the Mean|0.029||0.6564||95.0|-0.07|0.04|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for self-care|
1650596|NCT01700140|3037269|Superiority or Other|||||||0.1051|||||||Fisher Exact|||Statistical analysis for complete response rate after the first irradiation|
1651061|NCT01690273|3038182|Superiority or Other|||||||0.853|||||||Mixed Models Analysis||||
1650546|NCT01701362|3037104|Superiority or Other||least squares mean difference|-0.01|Standard Error of the Mean|0.037||0.6841||95.0|-0.09|0.06|||ANCOVA|This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.||This statistical analysis is for mobility|
1650547|NCT01701362|3037105|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.16||0.0168||95.0|-0.7|-0.07|||ANCOVA|This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.|||
1650548|NCT01701362|3037106|Superiority or Other||least squares mean difference|-0.46|Standard Error of the Mean|0.16||0.005||95.0|-0.77|-0.14|||ANCOVA|This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.|||
1650549|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.47|Standard Error of the Mean|0.12||0.0001||95.0|-0.71|-0.23|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Overall|
1650550|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.43|Standard Error of the Mean|0.15||0.0031||95.0|-0.71|-0.14|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 15|
1650551|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.5|Standard Error of the Mean|0.14||0.0005||95.0|-0.78|-0.22|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 14|
1650552|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.56|Standard Error of the Mean|0.14|<|0.0001||95.0|-0.84|-0.28|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 13|
1650553|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.54|Standard Error of the Mean|0.14|<|0.0001||95.0|-0.82|-0.27|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 12|
1650554|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.48|Standard Error of the Mean|0.14|<|0.0007||95.0|-0.76|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 11|
1650555|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.49|Standard Error of the Mean|0.14|<|0.0005||95.0|-0.77|-0.22|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 10|
1650556|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.54|Standard Error of the Mean|0.14|<|0.0001||95.0|-0.82|-0.26|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 9|
1650557|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.52|Standard Error of the Mean|0.14|<|0.0003||95.0|-0.79|-0.24|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 8|
1650558|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.48|Standard Error of the Mean|0.14|<|0.0008||95.0|-0.75|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 7|
1650559|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.48|Standard Error of the Mean|0.14|<|0.0006||95.0|-0.76|-0.21|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 6|
1650560|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.48|Standard Error of the Mean|0.14|<|0.0007||95.0|-0.75|-0.2|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 5|
1650561|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.44|Standard Error of the Mean|0.14|<|0.0016||95.0|-0.72|-0.17|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 4|
1650562|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.42|Standard Error of the Mean|0.14|<|0.0028||95.0|-0.69|-0.14|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 3|
1650563|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.34|Standard Error of the Mean|0.14|<|0.0135||95.0|-0.62|-0.07|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 2|
1650564|NCT01701362|3037107|Superiority or Other||least square mean difference|-0.35|Standard Error of the Mean|0.14|<|0.0119||95.0|-0.62|-0.08|||Mixed Model Repeated Measures Analysis|Analyzed for treatment, center, trauma type, week & treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.||Week 1|
1650565|NCT01701362|3037108|Superiority or Other|||||||0.0012||||||The p-value is derived from CMH test, stratified for pooled center and trauma type and excludes missing values.|Cochran-Mantel-Haenszel||||
1650566|NCT01701362|3037109|Superiority or Other||least squares mean difference|-0.22|Standard Error of the Mean|0.16||0.1823||95.0|-0.54|0.1|||Mixed Model Repeated Measures Analysis|Mixed Model Repeated Measures = MMRM|MMRM analysis includes fixed categorical effects of treatment, country, trauma type, visit week, treatment-by-visit interaction, and fixed continuous effect of baseline value. Missing mean pain scores imputed by multiple imputation method||
1650597|NCT01700140|3037269|Superiority or Other|||||||1|||||||Fisher Exact|||Statistical analysis for complete response rate after the first irradiation|
1650598|NCT01700140|3037270|Superiority or Other|||||||0.3099|||||||Fisher Exact|||Statistical analysis for complete control rate after the third irradiation|
1650567|NCT01701011|3037153|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the secondary outcome, depression. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.|
1650568|NCT01701011|3037154|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||To test the difference in psychological well-being between three groups with a power of 95%,a ¼ 0.05 and a medium effect size ( f ¼ 0.25), a total of 297 participants were required (99 patients per group). Taking into account a 20% attrition rate, at least 124 women had to be recruited in each group.|
1650569|NCT01701011|3037154|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||IBM SPSS Statistics 20 was used to perform the statistical analysis. A mixed model for repeated measures was used to examine the differences between the three groups over time for the primary outcome, anxiety. All models were estimated by the method of restricted maximum likelihood (REML) and the Compound Symmetry covariance structure was chosen for the repeated measures. The analysiswas performed according to the intention to treat.|
1650570|NCT01700985|3037158|Superiority||||||<|0.0001||||||At Day 15.|Fisher Exact||||
1650571|NCT01700985|3037159|Superiority||||||<|0.0001||||||At Day 15.|Fisher Exact||||
1650572|NCT01700985|3037160|Superiority||||||<|0.0001|||||||Fisher Exact||||
1650573|NCT01700621|3037201|Non-Inferiority|A noninferiority margin of −10% was chosen as the maximal absolute reduction in proportion seroprotection allowed in the concomitant measles-rubella and rotavirus vaccine group as compared to the measles-rubella vaccine alone group.|Seroconversion proportion difference|1.1|||||2-Sided|95.0|-6.9|9.0|||||||
1650574|NCT01700530|3037203|Superiority or Other||||||<|0.05|||||||ANOVA||||
1650575|NCT01700205|3037251|Other|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||||0.02|||||||Repeated Measure ANOVA|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample|
1650576|NCT01700205|3037252|Other|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||||||0.72|||||||Repeated Measure ANOVA|Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample|
1650577|NCT01700205|3037253|Other|ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.||||||0.72|||||||Repeated Measure ANOVA|ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.||Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor|
1650578|NCT01700205|3037254|Other|ANOVA with group (CMF, EHF) as between-subjects factor were conducted on intent-to-treat sample|||||<|0.05|||||||Repeated Measures ANOVA|We conducted a ANOVA with group (CMF, EHF) as between-subject factor.||ANOVAs were conducted with group (CMF, EHF) as the between-subjects factor.|
1650579|NCT01700205|3037255|Other|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).|Slope|-0.02||||0.32|2-Sided|95.0|-0.058|0.019|||Generalized Estimating Equation|GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction|||
1650580|NCT01700205|3037256|Other|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos). We provide below the parameter estimates for WLZ scores only.|Slope|-0.023||||0.001|2-Sided|95.0|-0.0362|-0.0093|||Generalized Estimating Equations|GEE analysis conducted on each type of Z score separately with group (CMF, EHF), time (infant age; 0.5-12.5 months) and their interaction.|||
1650581|NCT01700205|3037257|Other|A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).|Slope|-0.018|||<|0.05|2-Sided|95.0|-0.0363|-0.0002|||Generalized Estimating Equation|GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction.|||
1650582|NCT01700192|3037258|Superiority or Other||Treatment Difference Relative to Placebo|-16.0|||||2-Sided|95.0|-22.7|-8.3|||||||
1650583|NCT01700192|3037258|Superiority or Other||Median Difference (Final Values)|-6.1|||<|0.001|2-Sided|95.0|-9.1|-3.1|||Wilcoxon (Mann-Whitney)||||
1650584|NCT01700192|3037259|Superiority or Other||Treatment Difference Relative to Placebo|-16.7|||||2-Sided|95.0|-24.6|-4.0|||||||
1650585|NCT01700192|3037259|Superiority or Other||Median Difference (Final Values)|-1.1|||<|0.001|2-Sided|95.0|-1.7|-0.6|||Wilcoxon (Mann-Whitney)||||
1650586|NCT01700192|3037260|Superiority or Other||Treatment Difference Relative to Placebo|-18.4|||||2-Sided|95.0|-41.0|4.3|||||||
1650587|NCT01700192|3037260|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.154|2-Sided|95.0|-0.35|0.05|||Zero-inflated Log-normal Model||||
1650588|NCT01700192|3037261|Superiority or Other||Treatment Difference Relative to Placebo|-15.5|||||2-Sided|95.0|-24.4|-7.3|||||||
1650589|NCT01700192|3037261|Superiority or Other||Median Difference (Final Values)|-0.6|||<|0.001|2-Sided|95.0|-1.0|-0.3|||Wilcoxon (Mann-Whitney)||||
1650590|NCT01700192|3037264|Superiority or Other||Treatment Difference Relative to Placebo|-17.2|||||2-Sided|95.0|-25.0|-9.7|||||||
1650591|NCT01700192|3037264|Superiority or Other||Median Difference (Final Values)|-0.8|||<|0.001|2-Sided|95.0|-1.2|-0.4|||Wilcoxon (Mann-Whitney)||||
1650592|NCT01700140|3037269|Superiority or Other|||||||0.0511|||||||Fisher Exact|||Statistical analysis for complete response rate after the third irradiation|
1651062|NCT01690273|3038183|Superiority or Other|||||||0.526|||||||Mixed Models Analysis||||
1650601|NCT01700140|3037270|Superiority or Other|||||||0.4856|||||||Fisher Exact|||Statistical analysis for complete control rate after the second irradiation|
1650602|NCT01700140|3037270|Superiority or Other|||||||0.1051|||||||Fisher Exact|||Statistical analysis for complete control rate after the first irradiation|
1650603|NCT01700140|3037270|Superiority or Other|||||||1|||||||Fisher Exact|||Statistical analysis for complete control rate after the first irradiation|
1650604|NCT01700140|3037271|Superiority or Other||Hazard Ratio (HR)|0.828||||0.2701|2-Sided|95.0|0.566|1.21|||Generalized Wilcoxon test||||
1650605|NCT01700140|3037271|Superiority or Other||Hazard Ratio (HR)|1.213||||0.6466|2-Sided|95.0|0.616|2.388|||Generalized Wilcoxon test||||
1650606|NCT01700140|3037272|Superiority or Other||Hazard Ratio (HR)|0.423||||0.0724|2-Sided|95.0|0.144|1.237|||Generalized Wilcoxon test||||
1650607|NCT01700140|3037272|Superiority or Other||Hazard Ratio (HR)|0.918||||0.8361|2-Sided|95.0|0.266|3.172|||Generalized Wilcoxon test||||
1650608|NCT01700140|3037273|Superiority or Other|||||||0.1864|||||||Cochran-Armitage test||||
1650609|NCT01700140|3037273|Superiority or Other|||||||0.1527|||||||Fisher Exact||||
1650610|NCT01700140|3037273|Superiority or Other|||||||1|||||||Fisher Exact||||
1650611|NCT01700140|3037274|Superiority or Other|||||||0.2549|||||||Cochran-Armitage test||||
1650612|NCT01700140|3037274|Superiority or Other|||||||0.2284|||||||Fisher Exact||||
1650613|NCT01700140|3037274|Superiority or Other|||||||1|||||||Fisher Exact||||
1650614|NCT01699789|3037289|Superiority or Other||Risk Ratio (RR)|6.2|||<|0.01|2-Sided|95.0|1.54|24.9|||Log-linear model||For this sector, depression/mental health service is defined by client report of having assessment, counseling, education, medication discussion or referral for depression or emotional or mental health problems.|Adjusted analyses used multiply imputed data (N=410), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline status of the dependent variable and covariates and accounted for the design effect of the cluster randomization.|
1650615|NCT01699789|3037290|Superiority or Other||Risk Ratio (RR)|2.84|||<|0.01|2-Sided|95.0|1.39|5.8|||Log-linear model||For this sector, depression/mental health service is defined by client report of having assessment, counseling, education, medication discussion or referral for depression or emotional or mental health problems.|Adjusted analyses used multiply imputed data (N=588), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline status of the dependent variable and covariates and accounted for the design effect of the cluster randomization.|
1650616|NCT01699789|3037291|Superiority or Other||Risk Ratio (RR)|0.49|||||2-Sided|95.0|0.3|0.82||||||Adjusted analyses used multiply imputed data (N=553), weighted for eligible sample for enrollment; Poisson regression model adjusted for baseline status of the dependent variable and covariates and accounted for the design effect of the cluster randomization.|
1650617|NCT01699789|3037292|Superiority or Other||Odds Ratio (OR)|2.63|||<|0.01|2-Sided|95.0|1.4|4.94|||Regression, Logistic|||Adjusted analyses used multiply imputed data (N=1018), weighted for eligible sample for enrollment; logistic regression model adjusted for baseline status of the dependent variable and covariates and accounted for the design effect of the cluster randomization.|
1650618|NCT01699789|3037293|Superiority or Other||Odds Ratio (OR)|0.81|||||2-Sided|95.0|0.52|1.25|||||Median cut point for baseline variable.|Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, log-linear models, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650619|NCT01699789|3037294|Superiority or Other||Odds Ratio (OR)|0.34|||<|0.05|2-Sided|95.0|0.14|0.88|||Regression, Logistic||Median cut point for baseline variable.|Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, log-linear models, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650620|NCT01699789|3037295|Superiority or Other||Odds Ratio (OR)|0.59|||<|0.1|2-Sided|95.0|0.32|1.09|||Regression, Logistic||Population of individuals who are working.|Adjusted analyses used multiply imputed data (N= 249), weighted for eligible sample for enrollment; logistic regression model adjusted for baseline status of the dependent variable and covariates and accounted for the design effect of the cluster randomization.|
1650621|NCT01699789|3037296|Superiority or Other||Odds Ratio (OR)|1.09|||||2-Sided|95.0|0.69|1.7||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, log-linear models, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650622|NCT01699789|3037297|Superiority or Other||Odds Ratio (OR)|1.45|||<|0.05|2-Sided|95.0|1.03|2.04|||Regression, Logistic||"A response of somewhat or definitely true to my life is organized versus unsure or somewhat false or definitely false."|Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, log-linear models, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650623|NCT01699789|3037298|Superiority or Other||Odds Ratio (OR)|0.91|||||2-Sided|95.0|0.65|1.29||||||Intent-to-treat analyses of repeated measures that included all participants with available data at baseline, 6 months, or 12 months by using SAS software, version 9.2. A 3 level mixed effect regression model was used for the continuous variable MCS12 score, adjusted for age, sex, >= 3 chronic conditions, education, race ethnicity, income, family income below the federal poverty level, 12mo alcohol abuse or use of illicit drugs, 12mo depressive disorder, and community.|
1650727|NCT01696396|3037613|Superiority|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|23.7|||||2-Sided|90.0|2.8|39.2||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650624|NCT01699789|3037299|Superiority or Other||Rate Ratio (RR)|0.96|||||2-Sided|95.0|0.59|1.57||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, log-linear models, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650625|NCT01699789|3037300|Superiority or Other||Odds Ratio (OR)|0.87|||||2-Sided|95.0|0.55|1.39||||||Intent-to-treat analyses of repeated measures that included all participants with available data at baseline, 6 months, or 12 months by using SAS software, version 9.2. A 3 level mixed effect regression model was used for the continuous variable MCS12 score, adjusted for age, sex, >= 3 chronic conditions, education, race ethnicity, income, family income below the federal poverty level, 12mo alcohol abuse or use of illicit drugs, 12mo depressive disorder, and community.|
1650626|NCT01699789|3037301|Superiority or Other||Odds Ratio (OR)|0.65|||||2-Sided|95.0|0.34|1.25||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650627|NCT01699789|3037302|Superiority or Other||Odds Ratio (OR)|0.97|||||2-Sided|95.0|0.72|1.32||||||Intent-to-treat analyses of repeated measures that included all participants with available data at baseline, 6 months, or 12 months by using SAS software, version 9.2. A 3 level mixed effect regression model was used for the continuous variable MCS12 score, adjusted for age, sex, >= 3 chronic conditions, education, race ethnicity, income, family income below the federal poverty level, 12mo alcohol abuse or use of illicit drugs, 12mo depressive disorder, and community.|
1650628|NCT01699789|3037303|Superiority or Other||Odds Ratio (OR)|0.78|||||2-Sided|95.0|0.48|1.26||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650629|NCT01699789|3037304|Superiority or Other||Odds Ratio (OR)|0.92|||||2-Sided|95.0|0.61|1.4||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650630|NCT01699789|3037305|Superiority or Other||Odds Ratio (OR)|0.79|||||2-Sided|95.0|0.6|1.05||||||Intent-to-treat analyses of repeated measures that included all participants with available data at baseline, 6 months, or 12 months by using SAS software, version 9.2. A 3 level mixed effect regression model was used for the continuous variable MCS12 score, adjusted for age, sex, >= 3 chronic conditions, education, race ethnicity, income, family income below the federal poverty level, 12mo alcohol abuse or use of illicit drugs, 12mo depressive disorder, and community.|
1650631|NCT01699789|3037306|Superiority or Other||Odds Ratio (OR)|0.89|||||2-Sided|95.0|0.66|1.21||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650632|NCT01699789|3037307|Superiority or Other||Odds Ratio (OR)|1.03|||||2-Sided|95.0|0.74|1.42||||||Intent-to-treat analyses of repeated measures that included all participants with available data at baseline, 6 months, or 12 months by using SAS software, version 9.2. A 3 level mixed effect regression model was used for the continuous variable MCS12 score, adjusted for age, sex, >= 3 chronic conditions, education, race ethnicity, income, family income below the federal poverty level, 12mo alcohol abuse or use of illicit drugs, 12mo depressive disorder, and community.|
1650633|NCT01699789|3037308|Superiority or Other||Odds Ratio (OR)|1.01|||||2-Sided|95.0|0.7|1.46||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650634|NCT01699789|3037309|Superiority or Other||Odds Ratio (OR)|1.05|||||2-Sided|95.0|0.66|1.66||||||Intent-to-treat analyses of repeated measures that included all participants with available data at baseline, 6 months, or 12 months by using SAS software, version 9.2. A 3 level mixed effect regression model was used for the continuous variable MCS12 score, adjusted for age, sex, >= 3 chronic conditions, education, race ethnicity, income, family income below the federal poverty level, 12mo alcohol abuse or use of illicit drugs, 12mo depressive disorder, and community.|
1650635|NCT01699789|3037310|Superiority or Other||Odds Ratio (OR)|0.99|||||2-Sided|95.0|0.69|1.41||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650636|NCT01699789|3037311|Superiority or Other||Odds Ratio (OR)|0.7|||||2-Sided|95.0|0.4|1.22||||||Intent-to-treat analyses of repeated measures that included all participants with available data at baseline, 6 months, or 12 months by using SAS software, version 9.2. A 3 level mixed effect regression model was used for the continuous variable MCS12 score, adjusted for age, sex, >= 3 chronic conditions, education, race ethnicity, income, family income below the federal poverty level, 12mo alcohol abuse or use of illicit drugs, 12mo depressive disorder, and community.|
1650637|NCT01699789|3037312|Superiority or Other||Odds Ratio (OR)|0.51|||||2-Sided|95.0|0.28|0.95||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650638|NCT01699789|3037313|Superiority or Other||Odds Ratio (OR)|0.77|||||2-Sided|95.0|0.61|0.97||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650639|NCT01699789|3037314|Superiority or Other||Odds Ratio (OR)|0.61|||||2-Sided|95.0|0.38|0.96||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650640|NCT01699789|3037315|Superiority or Other||Odds Ratio (OR)|1.5|||||2-Sided|95.0|1.14|1.98||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650641|NCT01699789|3037316|Superiority or Other||Odds Ratio (OR)|1.75|||||2-Sided|95.0|1.19|2.59||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650642|NCT01699789|3037317|Superiority or Other||Odds Ratio (OR)|0.74|||||2-Sided|95.0|0.57|0.95||||||Intent-to-treat, comparative-effectiveness analyses with intervention status as the independent variable, using logistic regression, adjusted for baseline and covariates. We weighted data for 1,018 clients to characteristics of the eligible sample, with item-level imputation for missing data and wave-level imputation for missing surveys. Weights account for non-enrollment among eligible clients and attrition.|
1650643|NCT01699698|3037329|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1650644|NCT01698801|3037376|Superiority or Other||Overall dichotomized response rate|87.5|||<|0.0001|2-Sided|95.0|74.269|100.0||One sample binomial test for the overall response rate was performed to provide p-value (significance level: 0.05) based on EE population. The hypotheses of interest are: H0: p = 0.3, H1: p ≠ 0.3, where p is overall response.|Binomial test for dichotomized response||||
1650645|NCT01698775|3037378|Superiority or Other||Difference in least squares means|-0.4||||0.72|2-Sided|95.0|-2.7|1.9|||cLDA||||
1650646|NCT01698775|3037381|Superiority or Other||Difference in least squares means|-3.9||||0.54|2-Sided|95.0|-16.5|8.7|||ANCOVA||||
1650647|NCT01698775|3037382|Superiority or Other||Difference in percentage|2.8|||||2-Sided|95.0|-3.6|9.8|||||||
1650648|NCT01698775|3037383|Superiority or Other||Difference in percentage|-0.9|||||2-Sided|95.0|-12.2|10.3|||||Based on Miettinen & Nurminen method stratified by renal status stratum.||
1650649|NCT01698775|3037384|Superiority or Other||Difference in percentages|1.9|||||2-Sided|95.0|-2.6|7.2|||||Based on Miettinen & Nurminen method stratified by renal status stratum.||
1650650|NCT01698775|3037385|Superiority or Other||Difference in percentages|-3.8|||||2-Sided|95.0|-16.3|8.8|||||Based on Miettinen & Nurminen method stratified by renal status stratum.||
1650651|NCT01698775|3037386|Superiority or Other||Difference in least squares means|-0.33||||0.035|2-Sided|95.0|-0.63|-0.02|||ANCOVA||||
1650652|NCT01698463|3037403|Other||||||<|0.05||||||<0.05 (threshold for significance).|Wilcoxon (Mann-Whitney)||||
1650653|NCT01697956|3037432|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI for the geometric mean ratio of BDP nasal aerosol versus placebo was greater than 0.80.|ratio of BDP nasal aerosol to placebo|0.91|||||2-Sided|95.0|0.81|1.03||||||The standard deviation of the logarithmically transformed data on the change from baseline (expressed as a ratio) in 24-hr serum cortisol weighted mean is assumed to be 0.30. Using this standard deviation, 90 subjects (approximately 60 and 30 subjects in the BDP Nasal Aerosol and placebo groups, respectively) will yield approximately 90% power to demonstrate non-inferiority between BDP Nasal Aerosol and placebo, if there is no true difference between treatment groups.|
1650654|NCT01697748|3037434|Superiority||||||<|0.05|||||||Mixed Models Analysis||||In addition to the Chi-square, Fisher's exact test, Student T-Test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where approprate
1650655|NCT01697748|3037435|Superiority||||||<|0.05|||||||Mixed Models Analysis||||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test, and logistic regression were utilized where appropriate
1650656|NCT01697748|3037437|Superiority||||||<|0.05|||||||Mixed Models Analysis|Chi Square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test|||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where appropriate
1650657|NCT01697748|3037437|Superiority||||||<|0.05|||||||Mixed Models Analysis|Chi Square, Fisher's Exact, Student's T test, Wilcoxon-Mann-Whitney test and logistic regression when appropriate,|||Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney Test, and logistic regression were utilized where appropriate
1650658|NCT01697748|3037438|Superiority||||||<|0.05|||||||see below|Chi square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test where appropriate|||In addition to Chi-Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann Whitney test were utilized where appropriate
1650659|NCT01697748|3037439|Superiority|With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15% vs. 7.5%) surgical site infection at a two side alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|||||<|0.05||||||Variables with at least a borderline association (P≤.10) were then included in a multiple logistic regression model to verify which is independently associated with the outcome of interest|Mixed Models Analysis|In addition to the Chi-Square, Fisher's exact test, Student T-Test, Mann Whitney U test and logistic regression were utilized when appropriate.|||
1651063|NCT01690273|3038183|Superiority or Other|||||||0.057|||||||Mixed Models Analysis||||
1650660|NCT01697748|3037439|Superiority|With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|Odds Ratio (OR)|0.96|||<||2-Sided|95.0|0.44|1.96||||||With an SSI rate of 15% at Tampa General Hospital at the time of study design, a sample size of 600 patients was determined to provide a power of 80% to detect a 50% absolute reduction (15 vs. 7.5%) surgical site infection at a two sided alpha = 0.05. Assuming an approximate 10% dropout loss to follow up rate, the total sample size was adjusted to 660.|Besides the Chi Square, Fisher's Exact test, Student T-test, Mann Whitney U test, and logistic regression were utilized where appropriate
1650661|NCT01697592|3037451|Superiority or Other||Difference in the least squares means|-0.8|||<|0.001|2-Sided|95.0|-1.06|-0.54|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.|||
1650662|NCT01697592|3037451|Superiority or Other||Difference in the least squares means|-1.16|||<|0.001|2-Sided|95.0|-1.45|-0.88|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.|||
1650663|NCT01697592|3037451|Superiority or Other||Difference in the least squares means|-0.92|||<|0.001|2-Sided|95.0|-1.29|-0.56|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.|||
1650664|NCT01697592|3037451|Superiority or Other||Difference in the least squares means|-0.98|||<|0.001|2-Sided|95.0|-1.37|-0.6|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.|||
1650665|NCT01697592|3037451|Superiority or Other||Difference in the least squares means|-0.93|||<|0.001|2-Sided|95.0|-1.1|-0.75|||Constrained longitudinal data analysis|Constrained longitudinal data analysis with terms for treatment, basal AHA medication, prior AHA therapy status except for basal medication, and time.|||
1650666|NCT01697501|3037494|Superiority or Other|||||||0.0672|||||||Wald Chi Square||||
1650667|NCT01697501|3037495|Superiority or Other|||||||0.2642|||||||Wald Chi Square||||
1650668|NCT01697501|3037496|Superiority or Other||Odds Ratio (OR)|2.25||||0.1951|2-Sided|95.0|0.66|7.67|||univariate logistic analysis||||
1650669|NCT01697501|3037497|Superiority or Other||Odds Ratio (OR)|0.86||||0.7831|2-Sided|95.0|0.29|2.57|||univariate logistic analysis||||
1650670|NCT01697358|3037507|Superiority||||||<|0.001|||||||Z-test using unpooled standard deviation||||
1650671|NCT01697358|3037508|Superiority||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline PCS, treatment group, and virtual center.|||
1650672|NCT01697358|3037509|Superiority||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline ODI, treatment group, and virtual center.|||
1650673|NCT01697358|3037510|Superiority||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.|||
1650674|NCT01697358|3037511|Superiority||||||<|0.001|||||||Regression, Linear|Variables included in the linear regression model are: baseline NPRS, treatment group, and virtual center.|||
1650675|NCT01697358|3037512|Superiority|||||||0.036|||||||Z-test using unpooled standard deviation||||
1650676|NCT01697345|3037514|Superiority or Other||Mean Difference (Final Values)|-2.567|Standard Deviation|1.793|<|0.0005|2-Sided|95.0|-3.706|-1.428|||t-test, 2 sided||||
1650677|NCT01697345|3037515|Superiority or Other||Mean Difference (Final Values)|-1.9|Standard Deviation|1.355||0.001|2-Sided|95.0|-2.761|-1.039|||t-test, 2 sided||||
1650678|NCT01697345|3037516|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Deviation|1.18168||0.005|2-Sided|95.0|-1.9508|-0.4492|||t-test, 2 sided||||
1650679|NCT01697345|3037517|Superiority or Other||Mean Difference (Final Values)|-1.5|Standard Deviation|1.876||0.018|2-Sided|95.0|-2.692|-0.308|||t-test, 2 sided||||
1650680|NCT01697345|3037518|Superiority or Other||Median Difference (Final Values)|-1.625|Standard Deviation|1.369||0.002|2-Sided|95.0|-2.495|-0.755|||t-test, 2 sided||||
1650681|NCT01697345|3037519|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Deviation|0.88|<|0.0005|2-Sided|95.0|-1.859|-0.741|||t-test, 2 sided||||
1650682|NCT01697345|3037520|Superiority or Other||Mean Difference (Final Values)|-10.092|Standard Deviation|6.0378|<|0.0005|2-Sided|95.0|-13.928|-6.256|||t-test, 2 sided||||
1650683|NCT01696994|3037530|Superiority or Other (legacy)||Hazard Ratio (HR)|1.18|||||2-Sided|95.0|0.91|1.54|||||||
1650684|NCT01696994|3037540|Superiority or Other (legacy)||Hazard Ratio (HR)|1.21|||||2-Sided|95.0|0.99|1.48|||||||
1650685|NCT01696994|3037542|Superiority or Other (legacy)||Hazard Ratio (HR)|0.99|||||2-Sided|95.0|0.95|1.04|||||||
1650686|NCT01696981|3037547|Superiority or Other (legacy)||Hazard Ratio (HR)|0.74|||||2-Sided|95.0|0.63|0.87|||||||
1650687|NCT01696981|3037549|Superiority or Other (legacy)||Hazard Ratio (HR)|0.79|||||2-Sided|95.0|0.72|0.85|||||||
1650688|NCT01696981|3037551|Superiority or Other (legacy)||Hazard Ratio (HR)|0.98|||||2-Sided|95.0|0.95|1.0|||||||
1650689|NCT01696968|3037556|Superiority or Other (legacy)||Hazard Ratio (HR)|0.99|||||2-Sided|95.0|0.91|1.07|||||||
1650690|NCT01696968|3037560|Superiority or Other (legacy)||Hazard Ratio (HR)|1.05|||||2-Sided|95.0|0.98|1.12|||||||
1650691|NCT01696968|3037562|Superiority or Other (legacy)||Hazard Ratio (HR)|0.98|||||2-Sided|95.0|0.95|1.0|||||||
1650692|NCT01696968|3037564|Superiority or Other (legacy)||Hazard Ratio (HR)|0.99|||||2-Sided|95.0|0.91|1.07|||||||
1650693|NCT01696955|3037568|Superiority|||||||0.58|||||||Log Rank||||
1650694|NCT01696955|3037569|Superiority|||||||0.99|||||||Log Rank||||
1650695|NCT01696955|3037570|Superiority|||||||0.47|||||||t-test, 2 sided||||
1650696|NCT01696955|3037573|Superiority|||||||0.99|||||||Fisher Exact||||
1650746|NCT01696071|3037654|Superiority or Other||Mean Difference (Final Values)|-0.014|Standard Error of the Mean|0.018||||95.0|-0.051|0.023|||||Tio R5 qd – Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.|
1650697|NCT01696396|3037607|Superiority|Analysis was not part of the formal testing|LS Mean Treatment Difference|-16.37||||0.45|2-Sided|90.0|-51.8|19.1|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.|
1650698|NCT01696396|3037607|Superiority|Analysis was not part of the formal testing|LS Mean Treatment Difference|-23.59||||0.27|2-Sided|90.0|-58.7|11.5|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.|
1650699|NCT01696396|3037607|Superiority||LS Mean Treatment Difference|-27.47||||0.045|2-Sided|90.0|-50.0|-4.9|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.|
1650700|NCT01696396|3037608|Superiority|Analysis was not part of the formal testing|LS Mean Treatment Difference|-36.84||||0.11|2-Sided|90.0|-74.3|0.7|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.|
1650701|NCT01696396|3037608|Superiority|Analysis was not part of the formal testing|LS Mean Treatment Difference|-40.79||||0.095|2-Sided|90.0|-81.5|-0.5|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.|
1650702|NCT01696396|3037608|Superiority||LS Mean Treatment Difference|-42.09||||0.006|2-Sided|90.0|-67.3|-16.9|||IPW GEE Model|Adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.||Comparisons between treatment arms was conducted using an inverse probability weighting (IPW) generalized estimating equations (GEE) model adjusted for prior anti-TNF use, pre-versus post-protocol amendment 3 and baseline CDAI score.|
1650703|NCT01696396|3037609|Superiority|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|8.4|||||2-Sided|90.0|-6.0|17.9||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650704|NCT01696396|3037609|Superiority|Analysis was not part of the formal testing|Odds Ratio (OR)|2.66||||0.21|2-Sided|90.0|0.75|9.45|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650705|NCT01696396|3037609|Superiority|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|6.8|||||2-Sided|90.0|-4.3|14.5||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650706|NCT01696396|3037609|Superiority|Analysis was not part of the formal testing|Odds Ratio (OR)|2.32||||0.21|2-Sided|90.0|0.77|6.98|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650707|NCT01696396|3037609|Superiority||Difference in Adjusted Remission Rates|2.8|||||2-Sided|90.0|-4.7|8.1||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650708|NCT01696396|3037609|Superiority||Odds Ratio (OR)|1.52||||0.47|2-Sided|90.0|0.59|3.93|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650709|NCT01696396|3037610|Superiority|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|16.0|||||2-Sided|90.0|-1.2|28.3||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650710|NCT01696396|3037610|Superiority|Analysis was not part of the formal testing|Odds Ratio (OR)|3.37||||0.083|2-Sided|90.0|1.07|10.66|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650711|NCT01696396|3037610|Superiority|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|12.8|||||2-Sided|90.0|-0.6|22.6||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650877|NCT01692275|3037929|Superiority||Mean Difference (Final Values)|-2.7|||||2-Sided|95.0|-4.4|-1.1||||||San Diego site (week 12) - RMDQ Between-Group Differences in Disability|
1650712|NCT01696396|3037610|Superiority|Analysis was not part of the formal testing|Odds Ratio (OR)|2.82||||0.078|2-Sided|90.0|1.07|7.41|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650713|NCT01696396|3037610|Superiority||Difference in Adjusted Remission Rates|5.0|||||2-Sided|90.0|-3.9|11.7||||||The difference in sustained remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650714|NCT01696396|3037610|Superiority||Odds Ratio (OR)|1.65||||0.34|2-Sided|90.0|0.69|3.91|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650715|NCT01696396|3037611|Superiority|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|3.1|||||2-Sided|90.0|-17.4|18.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650716|NCT01696396|3037611|Superiority|Analysis was not part of the formal testing|Odds Ratio (OR)|1.15||||0.78|2-Sided|90.0|0.49|2.72|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650717|NCT01696396|3037611|Superiority|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|1.9|||||2-Sided|90.0|-15.2|15.2||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650718|NCT01696396|3037611|Superiority|Analysis was not part of the formal testing|Odds Ratio (OR)|1.09||||0.84|2-Sided|90.0|0.52|2.29|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650719|NCT01696396|3037611|Superiority||Difference in Adjusted Response Rates|16.0|||||2-Sided|90.0|2.4|27.1||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650720|NCT01696396|3037611|Superiority||Odds Ratio (OR)|1.98||||0.047|2-Sided|90.0|1.13|3.47|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650721|NCT01696396|3037612|Superiority|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|15.1|||||2-Sided|90.0|-6.4|31.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650722|NCT01696396|3037612|Superiority|Analysis was not part of the formal testing|Odds Ratio (OR)|1.87||||0.23|2-Sided|90.0|0.79|4.39|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650723|NCT01696396|3037612|Superiority|Analysis was not part of the formal testing|Difference in Adjusted Response Rates|15.7|||||2-Sided|90.0|-2.3|29.7||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650724|NCT01696396|3037612|Superiority|Analysis was not part of the formal testing|Odds Ratio (OR)|1.9||||0.14|2-Sided|90.0|0.94|3.87|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650725|NCT01696396|3037612|Superiority||Difference in Adjusted Response Rates|19.8|||||2-Sided|90.0|5.8|31.3||||||The difference in response rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650726|NCT01696396|3037612|Superiority||Odds Ratio (OR)|2.25||||0.021|2-Sided|90.0|1.27|4.01|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650747|NCT01696071|3037655|Superiority or Other||Mean Difference (Final Values)|-0.014|Standard Error of the Mean|0.018||||95.0|-0.05|0.022|||||Tio R5 qd – Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested|
1650728|NCT01696396|3037613|Superiority|Analysis was not part of the formal testing|Odds Ratio (OR)|3.1||||0.056|2-Sided|90.0|1.17|8.2|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650729|NCT01696396|3037613|Superiority|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|14.7|||||2-Sided|90.0|-2.1|27.5||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650730|NCT01696396|3037613|Superiority|Analysis was not part of the formal testing|Odds Ratio (OR)|2.12||||0.13|2-Sided|90.0|0.93|4.84|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650731|NCT01696396|3037613|Superiority||Difference in Adjusted Remission Rates|10.9|||||2-Sided|90.0|-1.8|21.0||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650732|NCT01696396|3037613|Superiority||Odds Ratio (OR)|1.78||||0.16|2-Sided|90.0|0.9|3.53|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650733|NCT01696396|3037614|Superiority|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|10.3|||||2-Sided|90.0|-6.8|22.6||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650734|NCT01696396|3037614|Superiority|Analysis was not part of the formal testing|Odds Ratio (OR)|2.05||||0.25|2-Sided|90.0|0.74|5.73|||Regression, Logistic|Adjusted for baseline total CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650735|NCT01696396|3037614|Superiority|Analysis was not part of the formal testing|Difference in Adjusted Remission Rates|9.1|||||2-Sided|90.0|-4.6|19.4||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650736|NCT01696396|3037614|Superiority|Analysis was not part of the formal testing|Odds Ratio (OR)|1.91||||0.22|2-Sided|90.0|0.8|4.57|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650737|NCT01696396|3037614|Superiority||Difference in Adjusted Remission Rates|1.6|||||2-Sided|90.0|-7.9|8.9||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650738|NCT01696396|3037614|Superiority|The study was powered for formal statistical testing of the abrilumab 70 mg group. The primary and key secondary endpoints were tested under a sequential framework of statistical hypotheses, each with 2-sided significance level of 0.10 for the treatment effect of abrilumab 70 mg compared with placebo.|Odds Ratio (OR)|1.15||||0.76|2-Sided|90.0|0.54|2.44|||Regression, Logistic|Adjusted for baseline CDAI score and stratification factors.|An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline CDAI score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650739|NCT01696071|3037647|Superiority or Other||Mean Difference (Final Values)|-1.389|Standard Error of the Mean|3.658||||95.0|-8.651|5.873|||||Tio R5 qd – Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested|
1650740|NCT01696071|3037648|Superiority or Other||Mean Difference (Final Values)|0.041|Standard Error of the Mean|0.035||||95.0|-0.03|0.111|||||Tio R5 qd – Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested|
1650741|NCT01696071|3037649|Superiority or Other||Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.026||||95.0|-0.07|0.032|||||Tio R5 qd – Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested|
1650742|NCT01696071|3037650|Superiority or Other||Mean Difference (Final Values)|-0.006|Standard Error of the Mean|0.02||||95.0|-0.047|0.034|||||Tio R5 qd – Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested|
1650743|NCT01696071|3037651|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.023||||95.0|-0.048|0.042|||||Tio R5 qd – Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested|
1650744|NCT01696071|3037652|Superiority or Other||Mean Difference (Final Values)|-0.005|Standard Error of the Mean|0.02||||95.0|-0.044|0.035|||||Tio R5 qd – Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.|
1650745|NCT01696071|3037653|Superiority or Other||Mean Difference (Final Values)|0.004|Standard Error of the Mean|0.032||||95.0|-0.06|0.068|||||Tio R5 qd – Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.|
1651064|NCT01690273|3038183|Superiority or Other|||||||0.874|||||||Mixed Models Analysis||||
1650748|NCT01696071|3037656|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.021||||95.0|-0.032|0.052|||||Tio R5 qd – Tio R2.5 bid|No p-values are presented as no formal statistical hypothesis was tested.|
1650749|NCT01696071|3037657|Superiority or Other||Mean Difference (Final Values)|-0.002|Standard Error of the Mean|0.018||||95.0|-0.038|0.034|||||Tio R5 QD – Tio R2.5 BID|No p-values are presented as no formal statistical hypothesis was tested.|
1650750|NCT01696058|3037658|Superiority or Other||Mean difference from Tio+Placebo Week 12|-0.483|Standard Error of the Mean|0.094|<|0.0001|2-Sided|95.0|-0.668|-0.298|||ANCOVA|||"Week 12 - Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."|
1650751|NCT01696058|3037659|Superiority or Other||Mean difference from Tio+Placebo Week 1|-0.09|Standard Error of the Mean|0.045||0.0467|2-Sided|95.0|-0.178|-0.001|||ANCOVA|||"Week 12 - Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."|
1650752|NCT01696058|3037660|Superiority or Other||Mean difference from Tio+Placebo Week 12|-0.568|Standard Error of the Mean|0.118|<|0.0001|2-Sided|95.0|-0.8|-0.336|||ANCOVA|||"Week 12 - Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)."|
1650753|NCT01696058|3037661|Superiority or Other||Mean difference from Tio+Placebo Week 12|7.237|Standard Error of the Mean|2.145||0.0008|2-Sided|95.0|3.028|11.446|||ANCOVA|||"Week 12: Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)."|
1650754|NCT01696058|3037662|Superiority or Other||Mean Difference (Final Values)|0.034|Standard Error of the Mean|0.022||0.1156|2-Sided|95.0|-0.008|0.076|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550)."|
1650755|NCT01696058|3037663|Superiority or Other||Mean Difference (Final Values)|0.104|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.057|0.152|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."|
1650756|NCT01696058|3037664|Superiority or Other||Mean Difference (Final Values)|0.118|Standard Error of the Mean|0.023|<|0.0001|2-Sided|95.0|0.072|0.164|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."|
1650757|NCT01696058|3037665|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.071|0.129|||Mixed Model Repeated Measure|||"Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used.~Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563)."|
1650758|NCT01696058|3037666|Superiority or Other||Mean Difference (Final Values)|-1.854|Standard Error of the Mean|0.461|<|0.0001|2-Sided|95.0|-2.757|-0.951|||ANCOVA|||"Results are from ANCOVA model. Fixed effects include study, treatment and baseline.~Number of patients contributing to models: Tio+Placebo (1055), Tio+Olo 5ug (1039)."|
1650759|NCT01696058|3037667|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.013||0.0029|2-Sided|95.0|0.014|0.065|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (555), Tio+Olo 5ug (550).|
1650760|NCT01696058|3037668|Superiority or Other||Mean Difference (Final Values)|0.106|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.078|0.135|||Mixed Model Repeated Measure|||Results are from an mixed model repeated measure (MMRM) model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (566), Tio+Olo 5ug (563).|
1650761|NCT01695993|3037675|Other|Primary Analysis: The Primary Aim to determine whether acupressure bands provided with efficacy-enhancing supplementary material are more effective in controlling chemotherapy-induced nausea than acupressure bands provided with neutral supplementary material was examined using ANCOVA with Peak Nausea after the first chemotherapy as the response, Arm (Arms 2 and 3) as the factor and expectancy of acupressure bands as the covariate.|Mean Difference (Net)|0.03|Standard Deviation|1.9||0.05|2-Sided|||||Not adjusted|ANCOVA||||
1650762|NCT01695239|3037734|Superiority or Other||||||<|0.001|||||||Regression, Logistic||||
1650763|NCT01695239|3037734|Superiority or Other||||||<|0.001|||||||Regression, Logistic||||
1650764|NCT01695239|3037734|Superiority or Other||||||<|0.001|||||||Regression, Logistic||||
1650765|NCT01695135|3037742|Superiority||Hazard Ratio (HR)|0.528||||0.0002|2-Sided|95.0|0.376|0.74|||Log Rank||||
1650766|NCT01694771|3037747|Superiority or Other||Mean difference from Tio+Placebo Week 12|-0.393|Standard Error of the Mean|0.098|<|0.0001|2-Sided|95.0|-0.586|-0.2|||ANCOVA|||"Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."|
1650767|NCT01694771|3037748|Superiority or Other||Mean difference from Tio+Placebo Week 12|-0.083|Standard Error of the Mean|0.041||0.0442|2-Sided|95.0|-0.164|-0.002|||ANCOVA|||"Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."|
1650768|NCT01694771|3037749|Superiority or Other||Mean difference from Tio+Placebo Week 12|-0.478|Standard Error of the Mean|0.116|<|0.0001|2-Sided|95.0|-0.706|-0.25|||ANCOVA|||"Week 12: Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."|
1650769|NCT01694771|3037750|Superiority or Other||Mean difference from Tio+Placebo Week 12|8.459|Standard Error of the Mean|2.192||0.0001|2-Sided|95.0|4.159|12.759|||ANCOVA|||"Week 12: Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (561), Tio+Olo 5ug (557)."|
1650770|NCT01694771|3037751|Superiority or Other||Mean difference from Tio + Placebo|0.153|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.106|0.201|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).|
1650771|NCT01694771|3037752|Superiority or Other||Mean difference from Tio + Placebo|0.063|Standard Error of the Mean|0.022||0.0047|2-Sided|95.0|0.019|0.106|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (551), Tio+Olo 5ug (548).|
1650772|NCT01694771|3037753|Superiority or Other||Mean difference from Tio + Placebo|0.146|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.1|0.192|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).|
1650773|NCT01694771|3037754|Superiority or Other||Mean change from baseline|0.119|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.09|0.147|||Mixed model repeated measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).|
1650774|NCT01694771|3037755|Superiority or Other||Mean Difference (Final Values)|0.062|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.037|0.088|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (551), Tio+Olo 5ug (548).|
1650775|NCT01694771|3037756|Superiority or Other||Mean Difference (Final Values)|0.117|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.09|0.144|||Mixed Model Repeated Measure|||Results are from an MMRM model. Fixed effects include treatment, visit, treatment by visit interaction, baseline and baseline by visit interaction. Patient is considered random and an unstructured covariance structure was used. Number of patients contributing to models: Tio+Placebo (564), Tio+Olo 5ug (563).|
1650776|NCT01694706|3037757|Non-Inferiority or Equivalence|no formal testing, investigation of bioavailability|Geometric Mean Ratio|94.72|Standard Deviation|31.4||0.0946|2-Sided|90.0|76.25|117.67|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)||
1650777|NCT01694706|3037757|Non-Inferiority or Equivalence|no formal testing, investigation of bioavailability|Geometric Mean Ratio|121.28|Standard Deviation|24.0||0.3765|2-Sided|90.0|102.32|143.74|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)||
1650778|NCT01694706|3037758|Non-Inferiority or Equivalence|no formal testing, investigation of bioavailability|Geometric Mean Ratio|93.55|Standard Deviation|53.0||0.2204|2-Sided|90.0|65.783|133.03|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)||
1650779|NCT01694706|3037758|Non-Inferiority or Equivalence|no formal testing, investigation of bioavailability|Geometric Mean Ratio|118.79|Standard Deviation|52.4||0.3993|2-Sided|90.0|83.19|169.628|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)||
1650780|NCT01694706|3037759|Non-Inferiority or Equivalence|no formal testing, investigation of bioavailability|Geometric Mean Ratio|94.33|Standard Deviation|30.8||0.0962|2-Sided|90.0|76.21|116.76|||ANOVA|Ratio calculated as Faldaprevir and Omeprazole divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)||
1650781|NCT01694706|3037759|Non-Inferiority or Equivalence|no formal testing, investigation of bioavailability|Geometric Mean Ratio|120.35|Standard Deviation|23.2||0.342|2-Sided|90.0|102.09|141.88|||ANOVA|Ratio calculated as Faldaprevir after a high-fat meal divided by Faldaprevir in fasting|Standard deviation is actually the geometric coefficient of variation (gCV)||
1650782|NCT01694563|3037771|Superiority||Clopper-Pearson|90.0|||||2-Sided|90.0||||||||Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 36 months post-operatively.|90% confidence interval using the Clopper-Pearson method.
1650783|NCT01694563|3037771|Superiority||Clopper-Pearson|90.0|||||2-Sided|90.0|||||||90% confidence interval calculated using the Clopper-Pearson method.|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 24 months post-operatively.|
1650784|NCT01694563|3037771|Superiority||Clopper-Pearson|90.0|||||2-Sided|90.0|||||||90% confidence interval calculated using the Clopper-Pearson method.|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 12 months post-operatively.|
1650785|NCT01694563|3037772|Superiority|||||||0.05|||||||Fisher Exact|||The primary effectiveness hypothesis for this study was to demonstrate a superiority success rate at 36-months follow-up in patients treated with the AtriCure Synergy Ablation System compared to a pre-established performance goal.|
1650786|NCT01694485|3037773|Superiority|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-1.7|||||2-Sided|90.0|-4.2|6.4||||||The difference in adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650874|NCT01692275|3037928|Superiority||Mean Difference (Final Values)|-0.2|||||2-Sided|95.0|-0.5|0.1||||||Walter Reed site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP|
1651065|NCT01690273|3038183|Superiority or Other|||||||0.69|||||||Mixed Models Analysis||||
1650787|NCT01694485|3037773|Superiority|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.49||||0.64|2-Sided|90.0|0.04|6.31|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650788|NCT01694485|3037773|Superiority|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-0.5|||||2-Sided|90.0|-3.9|6.2||||||The difference in adjusted sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650789|NCT01694485|3037773|Superiority|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.83||||0.86|2-Sided|90.0|0.16|4.41|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650790|NCT01694485|3037773|Superiority||Difference in Adjusted Remission Rates|1.0|||||2-Sided|90.0|-4.7|4.6||||||The difference in adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650791|NCT01694485|3037773|Superiority||Odds Ratio (OR)|1.32||||0.72|2-Sided|90.0|0.38|4.56|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650792|NCT01694485|3037773|Superiority||Difference in Adjusted Remission Rates|5.8|||||2-Sided|90.0|-0.6|10.4||||||The difference in adjusted sustained remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650793|NCT01694485|3037773|Superiority||Odds Ratio (OR)|2.94||||0.09|2-Sided|90.0|1.03|8.36|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio > 1.0 indicates a higher sustained remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using sustained remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650794|NCT01694485|3037774|Superiority|Analysis was not part of the formal testing.|Difference in Adjusted Healing Rates|-4.6|||||2-Sided|90.0|-14.9|11.3||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650795|NCT01694485|3037774|Superiority|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.69||||0.6|2-Sided|90.0|0.21|2.22|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio > 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650796|NCT01694485|3037774|Superiority|Analysis was not part of the formal testing.|Difference in Adjusted Healing Rates|-3.0|||||2-Sided|90.0|-11.9|9.4||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650797|NCT01694485|3037774|Superiority|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.8||||0.68|2-Sided|90.0|0.32|1.97|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio > 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650798|NCT01694485|3037774|Superiority||Difference in Adjusted Healing Rates|13.0|||||2-Sided|90.0|1.7|22.1||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650799|NCT01694485|3037774|Superiority|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.1||||0.041|2-Sided|90.0|1.15|3.82|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors|An odds ratio > 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650800|NCT01694485|3037774|Superiority||Difference in Adjusted Healing Rates|15.3|||||2-Sided|90.0|4.8|24.0||||||The difference in adjusted healing rates, estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650801|NCT01694485|3037774|Superiority|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.34||||0.011|2-Sided|90.0|1.35|4.07|||Regression, Logistic|Adjusted for baseline rectosigmoidoscopy score and stratification factors.|An odds ratio > 1.0 indicates a higher healing rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using healing rates estimated from a logistic regression model adjusted for baseline rectosigmoidoscopy score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650802|NCT01694485|3037775|Superiority|Analysis was not part of the formal testing.|Difference in Adjusted Response Rates|-13.7|||||2-Sided|90.0|-24.4|2.7||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650803|NCT01694485|3037775|Superiority|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.4||||0.18|2-Sided|90.0|0.13|1.22|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650804|NCT01694485|3037775|Superiority|Analysis was not part of the formal testing.|Difference in Adjusted Response Rates|21.2|||||2-Sided|90.0|4.9|34.1||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650805|NCT01694485|3037775|Superiority|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|2.54||||0.024|2-Sided|90.0|1.29|5.02|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650806|NCT01694485|3037775|Superiority||Difference in Adjusted Response Rates|21.4|||||2-Sided|90.0|9.0|31.8||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650807|NCT01694485|3037775|Superiority|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.57||||0.003|2-Sided|90.0|1.53|4.31|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650808|NCT01694485|3037775|Superiority||Difference in Adjusted Response Rates|23.4|||||2-Sided|90.0|11.8|33.2||||||The difference in adjusted response rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650809|NCT01694485|3037775|Superiority|If both comparisons of the primary endpoint reached statistical significance at 0.10, results from the 2 key secondary endpoints (response and mucosal healing at week 8) were to be sequentially (70 mg vs placebo then 210 mg vs placebo) tested at significance level of 0.05 independently of each other, according to the Bonferroni-based chain procedure.|Odds Ratio (OR)|2.78|||<|0.001|2-Sided|90.0|1.71|4.52|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio > 1.0 indicates a higher response rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using response rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650810|NCT01694485|3037776|Superiority|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-2.9|||||2-Sided|90.0|-5.5|5.4||||||The difference in remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650811|NCT01694485|3037776|Superiority|Comparisons of abrilumab 7 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.34||||0.49|2-Sided|90.0|0.03|4.33|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650812|NCT01694485|3037776|Superiority|Analysis was not part of the formal testing.|Difference in Adjusted Remission Rates|-1.6|||||2-Sided|90.0|-5.2|5.5||||||The difference in remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650875|NCT01692275|3037928|Superiority||Mean Difference (Final Values)|-0.4|||||2-Sided|95.0|-0.6|-0.2||||||All sites combined (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP|
1650876|NCT01692275|3037928|Superiority||Mean Difference (Final Values)|-0.4|||||2-Sided|95.0|-0.6|-0.2||||||All sites combined (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP|
1650813|NCT01694485|3037776|Superiority|Comparisons of abrilumab 21 mg with placebo were not included in the hypothesis testing procedure and were not adjusted for multiplicity.|Odds Ratio (OR)|0.64||||0.64|2-Sided|90.0|0.13|3.17|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650814|NCT01694485|3037776|Superiority||Difference in Adjusted Remission Rates|8.9|||||2-Sided|90.0|0.8|14.9||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650815|NCT01694485|3037776|Superiority|The study was powered for formal statistical testing of the abrilumab 70 mg and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.|Odds Ratio (OR)|3.33||||0.03|2-Sided|90.0|1.34|8.26|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors|An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650816|NCT01694485|3037776|Superiority||Difference in Adjusted Remission Rates|9.0|||||2-Sided|90.0|1.6|14.6||||||The difference in remission rates, estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650817|NCT01694485|3037776|Superiority|The study was powered for formal statistical testing of the abrilumab 70 mg and 210 mg groups. To account for multiplicity of statistical testing, primary and key secondary end points for the 2 highest doses of abrilumab (70 and 210 mg) were tested at the end of the 8-week induction period under a sequential framework at a 2-sided significance level of 0.10 using the Bonferroni-based chain procedure.|Odds Ratio (OR)|3.35||||0.021|2-Sided|90.0|1.41|7.95|||Regression, Logistic|Adjusted for baseline total Mayo Score and stratification factors.|An odds ratio > 1.0 indicates a higher remission rate for the abrilumab treatment group relative to placebo.|Comparisons between treatment groups were made using remission rates estimated from a logistic regression model adjusted for baseline total Mayo Score and stratification factors (prior vs no prior TNF antagonist use and enrollment pre- vs post-protocol amendment).|
1650818|NCT01694420|3037781|Superiority or Other||||||<|0.001||||||Study data compared to data as cited in PubMed ID: 21487250|Wilcoxon (Mann-Whitney)||||
1650819|NCT01694199|3037785|Superiority or Other|||||||0.9038|||||||ANOVA||||
1650820|NCT01694199|3037786|Superiority or Other|||||||0.5009|||||||ANOVA|||P = 0.5009|
1650821|NCT01694199|3037787|Superiority or Other|||||||0.1467|||||||ANOVA|||P=0.1467|
1650822|NCT01694199|3037788|Superiority or Other|||||||0.2766|||||||ANCOVA||||
1650823|NCT01694199|3037789|Superiority or Other|||||||0.3529|||||||ANCOVA||||
1650824|NCT01694108|3037796|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney-test comparing the decisional conflict scores of participating mothers vs. declining mothers.|||
1650825|NCT01693250|3037849|Superiority||Mean Difference (Final Values)|2.66||||0.001|2-Sided|95.0|||||Mixed Models Analysis|||We hypothesized the intervention group will have significant reduction of systematic blood pressure compared to the control group at 6 month follow up.|
1650826|NCT01693250|3037850|Superiority||Mean Difference (Final Values)|1.68|Standard Deviation|0.5|<|0.001|2-Sided|95.0|||||Mixed Models Analysis|||This is a feasibility and pilot study. We acknowledge that our sample size will not have adequate power to detect any statistically significant outcomes. We chose a sample size that would be large enough to assess feasibility and effect size and to accommodate recruitment within the study time and budget of this application. We hope to be able to estimate the effect size of the intervention.|
1650827|NCT01693185|3037856|Superiority or Other||||||<|0.001||||||We wished to be able to distinguish a difference of 7.5 min,|Wilcoxon (Mann-Whitney)|||Recovery time in patients administered remifentanil alone will be significantly shorter than that in patients administered midazolam-meperidine combination for colonoscopy.|
1650828|NCT01693120|3037857|Other|There was no pre-specified hypothesis to test|rate|0.0|||||2-Sided|95.0|0.0|6.1||||||There was no pre-specified hypothesis to test|
1650829|NCT01693120|3037858|Other|There was no prespecified hypothesis tested.|rate|90.7|||||2-Sided|95.0|84.3|95.1||||||There was no prespecified hypothesis tested.|
1650830|NCT01693120|3037859|Other|The goal of the analysis was to compute a two-sided 95% confidence interval around the 6-month effectiveness rate. There was no pre-specified hypothesis.|rate|52.6|||||2-Sided|95.0|43.1|62.1|||||||
1650831|NCT01693120|3037860|Superiority||rate|1.6||||0.175|1-Sided|95.0||4.9|||exact binomial test|||The null hypothesis was that the procedure or device related stroke rate within 30-days of a Phased RF ablation procedure was 3.5% or greater. The alternative hypothesis was that this rate was less than 3.5%. A sample size of 300 subjects provided 90% power to test the null hypothesis assuming the true stroke rate was 1.0% with a one-sided type I error rate of 0.05|
1650832|NCT01693068|3037871|Other|A log-rank test stratified by baseline Eastern Cooperative Oncology Group performance status (ECOG PS) (using the interactive voice response system [IVRS] value) will tested the null hypothesis of no difference between the Pimasertib (first line) and the Dacarbazine treatment groups at the 5% level.|Hazard Ratio (HR)|0.59||||0.0022|2-Sided|95.0|0.42|0.83|||Stratified Log Rank Test||The Hazard Ratio is obtained from the Cox Proportional Hazards model based on dacarbazine and pimasertib only stratified by baseline ECOG Performance Status.||
1650833|NCT01693029|3037875|Equivalence|"Equivalence margin (-0.5, 0.5) g/dL. Results from ANCOVA with factors treatment group and covariates mean baseline Hb and mean weekly dose during the evaluation period (Week 21-28)"|Mean Difference (Final Values)|-0.0926|||||2-Sided|90.0|-0.2264|0.0413|||||||95% confidence interval for the difference is (-0.2522, 0.0670).
1651066|NCT01690273|3038183|Superiority or Other|||||||0.99|||||||Mixed Models Analysis||||
1650834|NCT01692782|3037884|Superiority or Other||Mean Difference (Final Values)|-13.88||||0.019|2-Sided|||||p-value of SEP 225289 8 mg versus placebo at Week 4 was adjusted for multiple comparisons using the Hochberg procedure.|Mixed Models Analysis|||The 8 mg SEP 225289 group was compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.|
1650835|NCT01692782|3037884|Superiority or Other||Mean Difference (Final Values)|-12.38||||0.076|2-Sided||||||Mixed Models Analysis|P-values of SEP 225289 4 mg versus placebo at Week 4 was adjusted for multiple comparisons using the Hochberg procedure.||The 4 mg SEP 225289 group was compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.|
1650836|NCT01692782|3037884|Superiority or Other||Mean Difference (Final Values)|-9.7|||||2-Sided|||||||||The 4 mg and 8 mg SEP 225289 groups were compared to placebo using a MMRM analysis. The MMRM model included treatment, visit (as a categorical variable), pooled center, baseline ADHD RS-IV with adult prompts score, and treatment-by-visit interaction. An unstructured covariance matrix was used for the within subject correlation.|
1650837|NCT01692756|3037885|Superiority|||||||0.87|||||||Kruskal-Wallis||||
1650838|NCT01692756|3037886|Superiority|||||||0.2|||||||Kruskal-Wallis||||
1650839|NCT01692756|3037887|Superiority|||||||0.02|||||||Kruskal-Wallis||||
1650840|NCT01692756|3037888|Superiority|||||||0.62|||||||Kruskal-Wallis||||
1650841|NCT01692756|3037889|Superiority|||||||0.17|||||||Kruskal-Wallis||||
1650842|NCT01692756|3037890|Superiority|||||||0.63|||||||Kruskal-Wallis||||
1650843|NCT01692756|3037891|Superiority|||||||0.007|||||||Kruskal-Wallis||||
1650844|NCT01692756|3037892|Superiority|||||||0.003|||||||Kruskal-Wallis||||
1650845|NCT01692756|3037893|Superiority|||||||0.15|||||||Kruskal-Wallis||||
1650846|NCT01692756|3037894|Superiority|||||||0.13|||||||Kruskal-Wallis||||
1650847|NCT01692756|3037895|Superiority|||||||0.93|||||||Kruskal-Wallis||||
1650848|NCT01692756|3037896|Superiority|||||||0.08|||||||Kruskal-Wallis||||
1650849|NCT01692756|3037897|Superiority|||||||0.33|||||||Kruskal-Wallis||||
1650850|NCT01692301|3037921|Superiority or Other||Mean Difference (Net)|-3.66|Standard Error of the Mean|1.42||0.01|2-Sided|95.0|-6.45|-0.87|||ANCOVA||||
1650851|NCT01692275|3037924|Superiority||Mean Difference (Final Values)|3.1|||||2-Sided|95.0|2.5|3.7||||||Naval Medical Center San Diego site: 6 weeks|
1650852|NCT01692275|3037924|Superiority||Mean Difference (Final Values)|2.3|||||2-Sided|95.0|1.6|3.0||||||Naval Hospital Pensacola site: 6 weeks|
1650853|NCT01692275|3037924|Superiority||Mean Difference (Final Values)|2.0|||||2-Sided|95.0|1.4|2.6||||||Walter Reed site: 6 weeks|
1650854|NCT01692275|3037924|Superiority||Mean Difference (Final Values)|2.5|||||2-Sided|95.0|2.1|2.8||||||All sites combined: 6 weeks|
1650855|NCT01692275|3037925|Superiority||Odds Ratio (OR)|0.13|||||2-Sided|95.0|0.08|0.21||||||Naval Medical Center San Diego site: 6 weeks|
1650856|NCT01692275|3037925|Superiority||Odds Ratio (OR)|0.18|||||2-Sided|95.0|0.1|0.33||||||Naval Hospital Pensacola site: 6 weeks|
1650857|NCT01692275|3037925|Superiority||Odds Ratio (OR)|0.26|||||2-Sided|95.0|0.16|0.42||||||Walter Reed site: 6 weeks|
1650858|NCT01692275|3037925|Superiority||Odds Ratio (OR)|0.18|||||2-Sided|95.0|0.13|0.25||||||All sites combined: 6 weeks|
1650859|NCT01692275|3037926|Superiority||Odds Ratio (OR)|0.76|||||2-Sided|95.0|0.58|1.0||||||Week 12: All 3 sites combined|
1650860|NCT01692275|3037926|Superiority||Odds Ratio (OR)|0.73|||||2-Sided|95.0|0.54|0.97||||||Week 6: All 3 sites combined|
1650861|NCT01692275|3037927|Superiority||Mean Difference (Final Values)|-1.2|||||2-Sided|95.0|-1.9|-0.5||||||San Diego site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean|
1650862|NCT01692275|3037927|Superiority||Mean Difference (Final Values)|-1.6|||||2-Sided|95.0|-2.3|-1.0||||||San Diego site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean|
1650863|NCT01692275|3037927|Superiority||Mean Difference (Final Values)|-1.5|||||2-Sided|95.0|-2.3|-0.8||||||Pensacola site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean|
1650864|NCT01692275|3037927|Superiority||Mean Difference (Final Values)|-1.3|||||2-Sided|95.0|-2.0|-0.7||||||Pensacola site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean|
1650865|NCT01692275|3037927|Superiority||Mean Difference (Final Values)|-0.8|||||2-Sided|95.0|-1.5|-0.1||||||Walter Reed site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean|
1650866|NCT01692275|3037927|Superiority||Mean Difference (Final Values)|-0.7|||||2-Sided|95.0|-1.3|-0.02||||||Walter Reed site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean|
1650867|NCT01692275|3037927|Superiority||Mean Difference (Final Values)|-1.1|||||2-Sided|95.0|-1.6|-0.7||||||All sites combined (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean|
1650868|NCT01692275|3037927|Superiority||Mean Difference (Final Values)|-1.2|||||2-Sided|95.0|-1.6|-0.8||||||All sites combined (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean|
1650869|NCT01692275|3037928|Superiority||Mean Difference (Final Values)|-0.4|||||2-Sided|95.0|-0.7|-0.1||||||San Diego site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP|
1650870|NCT01692275|3037928|Superiority||Mean Difference (Final Values)|-0.5|||||2-Sided|95.0|-0.7|-0.2||||||San Diego site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP|
1650871|NCT01692275|3037928|Superiority||Mean Difference (Final Values)|-0.5|||||2-Sided|95.0|-0.8|-0.2||||||Pensacola site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP|
1650872|NCT01692275|3037928|Superiority||Mean Difference (Final Values)|-0.5|||||2-Sided|95.0|-0.8|-0.2||||||Pensacola site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP|
1650873|NCT01692275|3037928|Superiority||Mean Difference (Final Values)|-0.2|||||2-Sided|95.0|-0.5|0.1||||||Walter Reed site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP|
1650878|NCT01692275|3037929|Superiority||Mean Difference (Final Values)|-2.7|||||2-Sided|95.0|-4.3|-1.1||||||San Diego site (week 6) - RMDQ Between-Group Differences in Disability|
1650879|NCT01692275|3037929|Superiority||Mean Difference (Final Values)|-1.9|||||2-Sided|95.0|-3.7|-0.2||||||Pensacola site (week 12) - RMDQ Between-Group Differences in Disability|
1650880|NCT01692275|3037929|Superiority||Mean Difference (Final Values)|-2.1|||||2-Sided|95.0|-3.8|-0.4||||||Pensacola site (week 6) - RMDQ Between-Group Differences in Disability|
1650881|NCT01692275|3037929|Superiority||Mean Difference (Final Values)|-1.5|||||2-Sided|95.0|-3.2|0.2||||||Walter Reed site (week 12) - RMDQ Between-Group Differences in Disability|
1650882|NCT01692275|3037929|Superiority||Mean Difference (Final Values)|-1.8|||||2-Sided|95.0|-3.4|-0.2||||||Walter Reed site (week 6) - RMDQ Between-Group Differences in Disability|
1650883|NCT01692275|3037929|Superiority||Mean Difference (Final Values)|-2.0|||||2-Sided|95.0|-3.0|-1.0||||||All sites combined (week 12) - RMDQ Between-Group Differences in Disability|
1650884|NCT01692275|3037929|Superiority||Mean Difference (Final Values)|-2.2|||||2-Sided|95.0|-3.1|-1.2||||||All sites combined (week 6) - RMDQ Between-Group Differences in Disability|
1650885|NCT01692275|3037930|Superiority||Mean Difference (Final Values)|-1.1|||||2-Sided|95.0|-1.7|-0.5||||||Naval Medical Center San Diego (week 12) - Between-group differences of mean in LBP|
1650886|NCT01692275|3037930|Superiority||Mean Difference (Final Values)|-1.3|||||2-Sided|95.0|-1.9|-0.8||||||Naval Medical Center San Diego site (week 6) - Between-group differences of mean in LBP|
1650887|NCT01692275|3037930|Superiority||Mean Difference (Final Values)|-1.1|||||2-Sided|95.0|-1.8|-0.5||||||Naval Hospital Pensacola site (week 12) - Between-group differences of mean in LBP|
1650888|NCT01692275|3037930|Superiority||Mean Difference (Final Values)|-1.2|||||2-Sided|95.0|-1.8|-0.6||||||Naval Hospital Pensacola site (week 6) - Between-group differences of mean in LBP|
1650889|NCT01692275|3037930|Superiority||Mean Difference (Final Values)|-0.4|||||2-Sided|95.0|-1.0|0.2||||||Walter Reed site (week 12) - Between-group differences of mean in LBP|
1650890|NCT01692275|3037930|Superiority||Mean Difference (Final Values)|-0.7|||||2-Sided|95.0|-1.3|-0.1||||||Walter Reed site (week 6) - Between-group differences of mean in LBP|
1650891|NCT01692275|3037930|Superiority||Mean Difference (Final Values)|-0.9|||||2-Sided|95.0|-1.2|-0.5||||||All sites combined (week 12) - Between-group differences of mean in LBP|
1650892|NCT01692275|3037930|Superiority||Mean Difference (Final Values)|-1.1|||||2-Sided|95.0|-1.4|-0.7||||||All sites combined (week 6) - Between-group differences of mean in LBP|
1650893|NCT01691885|3037989|Superiority or Other||Mean Difference (Final Values)|5.83|||<|0.001|2-Sided|95.0|2.74|8.91|||ANCOVA|Analysis was performed using an ANCOVA model with covariates of treatment, baseline, period and subject as a random effect.|||
1650894|NCT01691781|3038044|Superiority|||||||0.8||||||This p-value reflects the statistic for the comparison of mean calcium levels for the normal control participants without primary hyperparathyroidism.|t-test, 2 sided|||The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.|
1650895|NCT01691781|3038044|Superiority|||||||0.48||||||This p-value reflects the statistic for the comparison of mean calcium levels for the primary hyperparathyroidism group.|t-test, 2 sided|||The statistical analysis compared the change in serum calcium, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.|
1650896|NCT01691781|3038045|Superiority|||||||0.86||||||This p-value reflects the mean difference in 24h aldosterone excretion rate among normal control participants without primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among normal control participants without primary hyperparathyroidism.|
1650897|NCT01691781|3038045|Superiority|||||||0.22||||||This p-value reflects the comparison of means among the primary hyperparathyroidism group only.|t-test, 2 sided|||The statistical analysis compared the change in urinary aldosterone excretion rate, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.|
1650898|NCT01691781|3038046|Superiority|||||||0.8||||||This p-value reflects the difference in PTH means among normal control participants without primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among normal control participants (without primary hyperparathyroidism).|
1650899|NCT01691781|3038046|Superiority|||||||0.049||||||This p-value reflects the difference in PTH means among participants with primary hyperparathyroidism|t-test, 2 sided|||The statistical analysis compared the change in PTH, before and after ACE inhibitor therapy, among participants with primary hyperparathyroidism.|
1650900|NCT01691768|3038048|Superiority||Risk Ratio (RR)|0.91||||0.462|2-Sided|95.0|0.7|1.18|||Regression, Log-binomial||||
1650901|NCT01691768|3038049|Superiority||incidence rate ratio|0.33||||0.097|2-Sided|95.0|0.06|1.32|||z-test||We calculated incidence rate ratio, where the HPV incidence rate for the intervention arm represents the numerator and the HPV incidence rate for the control arm represents the denominator.||
1650902|NCT01691768|3038051|Superiority|||||||0.455|||||||t-test, 2 sided||||
1650903|NCT01691768|3038052|Superiority||Risk Ratio (RR)|1.08||||0.304|2-Sided|95.0|0.94|1.24|||Regression, Log-binomial|||Power was not calculated for all secondary outcomes.|
1650904|NCT01691768|3038053|Superiority||incidence rate ratio|0.96||||0.895|2-Sided|95.0|0.45|2.04|||z-test|We used z-test to compare pregnancy incidence rates between the arms. We did not use log-rank test because we did not present survival curves.|We calculated incidence rate ratio, where the pregnancy incidence rate for the intervention arm represents the numerator and the pregnancy incidence rate for the control arm represents the denominator.|Power was not calculated for all the secondary outcomes.|
1650905|NCT01691768|3038054|Superiority||Incidence rate ratio|0.96||||0.928|2-Sided|95.0|0.4|2.35|||z-test|We used z-test to compare incidence rates between the arms. We did not use log-rank test because we did not present survival curves.|We calculated incidence rate ratio, where the HIV incidence rate for the intervention arm represents the numerator and the HIV incidence rate for the control arm represents the denominator.|The power was not calculated for all the secondary outcomes.|
1651067|NCT01690273|3038183|Superiority or Other|||||||0.003|||||||Mixed Models Analysis||||
1651068|NCT01690273|3038184|Superiority or Other|||||||0.9|||||||Mixed Models Analysis||||
1650906|NCT01691768|3038055|Non-Inferiority|We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control)|Median Difference (Final Values)|-0.25|||||2-Sided|95.0|-0.98|0.48|||||We calculated the difference in means between the two arms. The mean from the intervention arm was the minuend and the mean from the control arm was the subtrahend.|This is the analyses from the per protocol population (excluding all subsequent data collected from participants who were not dispensed product for more than 120 days).|
1650907|NCT01691768|3038055|Non-Inferiority|We estimated that we would need to enrol 700 women after taking into account the anticipated loss-to follow-up in order to provide 90% power to demonstrate whether gel use in women attending family planning (intervention) services is similar to, but no more than 20% lower than, gel use among women attending CAPRISA research clinics (control).|Mean Difference (Final Values)|-0.47|||||2-Sided|95.0|-1.16|0.21|||||The least square mean from the intervention arm was the minuend and the least square mean from the control arm was the subtrahend.|Intent to treat population (all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data) was used for this analyses.|The primary endpoint was compared using univariate linear mixed model with compound symmetry structure.
1650908|NCT01691560|3038063|Superiority or Other||Adjusted Mean Difference|0.09||||0.8322|2-Sided|95.0|-0.75|0.93|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650909|NCT01691560|3038063|Superiority or Other||Adjusted Mean Difference|0.76||||0.0811|2-Sided|95.0|-0.09|1.61|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650910|NCT01691560|3038063|Superiority or Other||Adjusted Mean Difference|0.85||||0.0503|2-Sided|95.0|0.0|1.69|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650911|NCT01691560|3038063|Superiority or Other||Adjusted Mean Difference|-0.45||||0.2917|2-Sided|95.0|-1.29|0.39|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650912|NCT01691560|3038063|Superiority or Other||Adjusted Mean Difference|-0.54||||0.2023|2-Sided|95.0|-1.37|0.29|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650913|NCT01691560|3038063|Superiority or Other||Adjusted Mean Difference|0.31||||0.4797|2-Sided|95.0|-0.55|1.16|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650914|NCT01691560|3038064|Superiority or Other||Adjusted Mean Difference|0.28||||0.4692|2-Sided|95.0|-0.48|1.03|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650915|NCT01691560|3038064|Superiority or Other||Adjusted Mean Difference|-0.1||||0.801|2-Sided|95.0|-0.86|0.67|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650916|NCT01691560|3038064|Superiority or Other||Adjusted Mean Difference|0.18||||0.6433|2-Sided|95.0|-0.58|0.94|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650917|NCT01691560|3038064|Superiority or Other||Adjusted Mean Difference|0.13||||0.7421|2-Sided|95.0|-0.63|0.88|||ANCOVA|From ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650918|NCT01691560|3038064|Superiority or Other||Adjusted Mean Difference|-0.15||||0.6918|2-Sided|95.0|-0.9|0.6|||ANCOVA|ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650936|NCT01691560|3038067|Superiority or Other||Median Difference (Final Values)|0.0||||0.1133|2-Sided|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test.|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650919|NCT01691560|3038064|Superiority or Other||Adjusted Mean Difference|0.03||||0.9421|2-Sided|95.0|-0.74|0.8|||ANCOVA|ANCOVA with treatment and Schiff stratification as factors and baseline VRS as covariate.|Difference is first named treatment minus second named treatment that a negative difference implies the mean of second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650920|NCT01691560|3038065|Superiority or Other||Median Difference (Final Values)|0.0||||0.3829|2-Sided|95.0|-5.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650921|NCT01691560|3038065|Superiority or Other||Median Difference (Final Values)|0.0||||0.169|2-Sided|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650922|NCT01691560|3038065|Superiority or Other||Median Difference (Final Values)|0.0||||0.0871|2-Sided|95.0|-10.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650923|NCT01691560|3038065|Superiority or Other||Median Difference (Final Values)|0.0||||0.1831||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650924|NCT01691560|3038065|Superiority or Other||Median Difference (Final Values)|0.0||||0.0641|2-Sided|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650925|NCT01691560|3038065|Superiority or Other||Median Difference (Final Values)|0.0||||0.8861|2-Sided|95.0|-5.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650926|NCT01691560|3038066|Superiority or Other||Adjusted Mean Difference|0.0||||0.9974|2-Sided|95.0|-0.32|0.32|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650927|NCT01691560|3038066|Superiority or Other||Adjusted Mean Difference|0.48||||0.004|2-Sided|95.0|0.16|0.81|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Treatment as fixed factor, baseline Schiff score as covariate. Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650928|NCT01691560|3038066|Superiority or Other||Adjusted Mean Difference|0.49||||0.0037|2-Sided|95.0|0.16|0.81|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650929|NCT01691560|3038066|Superiority or Other||Adjusted Mean Difference|-0.12||||0.4537|2-Sided|95.0|-0.45|0.2|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650930|NCT01691560|3038066|Superiority or Other||Adjusted Mean Difference|-0.12||||0.4484|2-Sided|95.0|-0.44|0.2|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650931|NCT01691560|3038066|Superiority or Other||Adjusted Mean Difference|0.36||||0.0292|2-Sided|95.0|0.04|0.69|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650932|NCT01691560|3038067|Superiority or Other||Median Difference (Final Values)|0.0||||0.5721|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650933|NCT01691560|3038067|Superiority or Other||Median Difference (Final Values)|0.0||||0.3259|2-Sided|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650934|NCT01691560|3038067|Superiority or Other||Median Difference (Final Values)|0.0||||0.6149|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test.|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650935|NCT01691560|3038067|Superiority or Other||Median Difference (Final Values)|0.0||||0.2579||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650937|NCT01691560|3038067|Superiority or Other||Median Difference (Final Values)|0.0||||0.0467|2-Sided|95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)|Hodges-Lehmann Wilcoxon non-parametric test|Difference is First named treatment minus Second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650938|NCT01691560|3038068|Superiority or Other||Adjusted Mean Difference|-0.03||||0.8031|2-Sided|95.0|-0.26|0.2|||ANCOVA||Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650939|NCT01691560|3038068|Superiority or Other||Adjusted mean difference|0.05||||0.6685|2-Sided|95.0|-0.18|0.29|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650940|NCT01691560|3038068|Superiority or Other||Adjusted Mean Difference|0.02||||0.8549|2-Sided|95.0|-0.21|0.25|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650941|NCT01691560|3038068|Superiority or Other||Adjusted Mean Difference|0.04||||0.7517|2-Sided|95.0|-0.2|0.27|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650942|NCT01691560|3038068|Superiority or Other||Adjusted mean difference|0.07||||0.5689|2-Sided|95.0|-0.16|0.3|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650943|NCT01691560|3038068|Superiority or Other||Adjusted Mean Difference|0.09||||0.4553|2-Sided|95.0|-0.14|0.32|||ANCOVA|From ANCOVA model with treatment and baseline included as covariate.|Difference is First named treatment minus Second named treatment that negative difference implies the mean of the second named treatment is larger than that of the first named treatment.|Null hypothesis considered change from baseline to be same for treatments in comparison.|
1650944|NCT01691521|3038079|Superiority or Other||Rate Ratio|0.47|||<|0.001|2-Sided|95.0|0.35|0.64||Hochberg procedure with a gamma parameter of 1 used for multiplicity adjustment.|Negative binomial model||Number of exacerbations per year in the mepolizumab 100 mg SC arm divided by the number of exacerbations per year in the placebo arm.||
1650945|NCT01691521|3038079|Superiority or Other||Rate Ratio|0.53|||<|0.001|2-Sided|95.0|0.4|0.72||Hochberg procedure with a gamma parameter of 1 used for multiplicity adjustment.|Negative binomial model||Number of exacerbations per year in the mepolizumab 75mg IV arm divided by the number of exacerbations per year in the placebo arm.||
1650946|NCT01691508|3038084|Superiority or Other||Odds Ratio (OR)|2.39||||0.008|2-Sided|95.0|1.25|4.56|||Proportional odds model||||
1650947|NCT01691482|3038085|Superiority or Other||Adjusted Mean|0.217|Standard Error of the Mean|0.014||||95.0|0.19|0.245|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650948|NCT01691482|3038085|Superiority or Other||Adjusted Mean|0.232|Standard Error of the Mean|0.014||||95.0|0.204|0.259|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650949|NCT01691482|3038085|Superiority or Other||Adjusted Mean|0.231|Standard Error of the Mean|0.014||||95.0|0.203|0.258|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650950|NCT01691482|3038085|Superiority or Other||Adjusted Mean|0.228|Standard Error of the Mean|0.014||||95.0|0.2|0.255|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650951|NCT01691482|3038086|Superiority or Other||Adjusted Mean|0.064|Standard Error of the Mean|0.0045||||95.0|0.055|0.073|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650952|NCT01691482|3038086|Superiority or Other||Adjusted Mean|0.069|Standard Error of the Mean|0.0045||||95.0|0.06|0.078|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650953|NCT01691482|3038086|Superiority or Other||Adjusted Mean|0.07|Standard Error of the Mean|0.0045||||95.0|0.061|0.079|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650954|NCT01691482|3038086|Superiority or Other||Adjusted Mean|0.067|Standard Error of the Mean|0.0045||||95.0|0.058|0.076|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650955|NCT01691482|3038087|Superiority or Other||Adjusted Mean|0.062||||||95.0|0.053|0.071|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1651069|NCT01690273|3038184|Superiority or Other|||||||0.007|||||||Mixed Models Analysis||||
1651070|NCT01690273|3038184|Superiority or Other|||||||0.213|||||||Mixed Models Analysis||||
1650956|NCT01691482|3038087|Superiority or Other||Adjusted Mean|0.053|Standard Error of the Mean|0.0046||||95.0|0.044|0.062|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650957|NCT01691482|3038087|Superiority or Other||Adjusted Mean|0.071|Standard Error of the Mean|0.0046||||95.0|0.062|0.08|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650958|NCT01691482|3038087|Superiority or Other||Adjusted Mean|0.058|Standard Error of the Mean|0.0046||||95.0|0.049|0.067|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650959|NCT01691482|3038091|Superiority or Other||Slope|0.062|Standard Error of the Mean|0.0046||||95.0|0.053|0.071|||||Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650960|NCT01691482|3038091|Superiority or Other||Adjusted Mean|0.053|Standard Error of the Mean|0.0046||||95.0|0.044|0.062|||||Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650961|NCT01691482|3038091|Superiority or Other||Adjusted Mean|0.071|Standard Error of the Mean|0.0046||||95.0|0.062|0.08|||||Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650962|NCT01691482|3038091|Superiority or Other||Adjusted Mean|0.058|Standard Error of the Mean|0.0046||||95.0|0.049|0.067|||||Treatment: A/S alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used.||
1650963|NCT01691378|3038102|Superiority||Mean Difference (Final Values)|-11.6||||0.002|2-Sided|95.0|-18.0|-5.3|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.|
1650964|NCT01691378|3038102|Superiority||Mean Difference (Final Values)|-8.7||||0.003|2-Sided|95.0|-13.8|-3.6|||Regression, Linear|||Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control & only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough “room” to change in Intervention period). Linear regression used with difference in change as dependent variable & Waitlist period change as only predictor. Estimated mean difference in change calculated from this model.|
1650965|NCT01691378|3038102|Superiority||Mean Difference (Final Values)|5.6||||0.13|2-Sided|95.0|-1.7|12.9|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum & Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BDI compared bet arms controlling for T1 BDI. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BDI as function of arm & T1 BDI. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."|
1650966|NCT01691378|3038103|Superiority||Mean Difference (Final Values)|-3.5||||0.06|2-Sided|95.0|-7.0|0.12|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.|
1650967|NCT01691378|3038103|Superiority||Mean Difference (Final Values)|-0.01||||0.94|2-Sided|95.0|-3.3|3.1|||Regression, Linear|||Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control & only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough “room” to change in Intervention period). Linear regression used with difference in change as dependent variable & Waitlist period change as only predictor. Estimated mean difference in change calculated from this model.|
1650968|NCT01691378|3038103|Superiority||Mean Difference (Final Values)|3.8||||0.07|2-Sided|95.0|-0.29|8.0|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum & Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BSS compared bet arms controlling for T1 BSS. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BSS as function of arm & T1 BSS. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."|
1650969|NCT01691378|3038104|Superiority||Mean Difference (Final Values)|-6.3||||0.0007|2-Sided|95.0|-9.3|-3.2|||one-sample t-test|||Analysis investigated change from T1 to T3 within the WtoH Intervention first arm only. This difference was calculated and a 1-sample t test was used to determine whether the estimate was different from zero. As this change was not compared with a control group change, baseline values were not accounted for.|
1650970|NCT01691378|3038104|Superiority||Mean Difference (Final Values)|-4.6||||0.01|2-Sided|95.0|-7.9|-1.3|||Regression, Linear|||Analysis contrasted T1 to T2 change with T2 to T3 change in Waitlist arm only. Waitlist participants serve as their own control & only variable controlled for was change in Waitlist period (if participants improved greatly during Waitlist period, they would no longer have enough “room” to change in Intervention period). Linear regression used with difference in change as dependent variable & Waitlist period change as only predictor. Estimated mean difference in change calculated from this model.|
1650996|NCT01690299|3038169|Superiority or Other (legacy)||Difference in LS Mean|-39.85|||<|0.0001|2-Sided|95.0|-51.78|-27.92|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.|||
1651071|NCT01690273|3038184|Superiority or Other|||||||0.94|||||||Mixed Models Analysis||||
1651072|NCT01690273|3038184|Superiority or Other|||||||0.99|||||||Mixed Models Analysis||||
1650971|NCT01691378|3038104|Superiority||Mean Difference (Final Values)|4.4||||0.03|2-Sided|95.0|0.52|8.3|||ANCOVA|||"Analyses 2-sided test w/ sig level .05. N=35 analyzed w/ α .05 provided 80% power to detect effect size d=1. T1 variables compared using Wilcoxon rank sum & Fisher exact tests. Per protocol analysis, all participants required T2 BHS.~T2 BHS compared bet arms controlling for T1 BHS. No confounders significant at .10, not included in model. Analysis of covariance modeled T2 BHS as function of arm & T1 BHS. Estimated mean difference in T2 scores calculated, no adjustment for multiple comparisons."|
1650972|NCT01691248|3038117|Superiority or Other||Percentage difference|1.9||||0.3091|2-Sided|95.0|-5.5|9.2||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin||
1650973|NCT01691248|3038118|Superiority or Other||Percentage difference|0.6||||0.442|2-Sided|95.0|-7.1|8.2||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin||
1650974|NCT01691248|3038119|Superiority or Other||Percentage Difference|2.2||||0.2778|2-Sided|95.0|-5.1|9.5||1-sided Wald test for a difference in proportions using an unpooled estimate of variance.|One-sided Wald p-value||Placebo minus Fidaxomicin||
1650975|NCT01691014|3038131|Superiority or Other|||||||0.39|||||||Fisher Exact|||HAQ: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.|
1650976|NCT01691014|3038131|Superiority or Other|||||||0.896|||||||Fisher Exact|||HAQ: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.|
1650977|NCT01691014|3038131|Superiority or Other|||||||0.458|||||||Fisher Exact|||HAQ: Month 3: Continuous variables were compared between treatment groups using one way ANOVA.|
1650978|NCT01691014|3038131|Superiority or Other|||||||0.945|||||||Fisher Exact|||HAQ: Baseline: Continuous variables were compared between treatment groups using one way ANOVA.|
1650979|NCT01691014|3038132|Superiority or Other|||||||0.98|||||||Fisher Exact|||DAS28: Month 12: Continuous variables were compared between treatment groups using one way ANOVA.|
1650980|NCT01691014|3038132|Superiority or Other|||||||0.586|||||||Fisher Exact|||DAS28: Month 6: Continuous variables were compared between treatment groups using one way ANOVA.|
1650981|NCT01691014|3038132|Superiority or Other|||||||0.99|||||||Fisher Exact|||DAS28: Month 3: Continuous variables were compared between treatment groups using one way analysis of variance (ANOVA).|
1650982|NCT01690988|3038140|Superiority|||||||0.03||||||"Patients where asked whether Following their surgery they had bad dreams or nightmares the response choices: Yes/No question The incidence of hallucination and nightmares were assessed separately and compared across the three study group."|Chi-squared||||
1650983|NCT01690988|3038141|Superiority|||||||0.01|||||||Chi-squared|||Frequency of patients reporting hallucinations using the DSAQ instrument.|
1650984|NCT01690988|3038143|Superiority||frequency-test|0.572||||0.572|2-Sided||||||Chi-squared|||"Assessed from patient-reported postoperative nausea and vomiting section of Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) Patients where asked whether they currently have nausea/vomiting AM & PM the response choices: None, Mild, Moderate, Severe Incidence of nausea\vomiting accounted for any positive reporting(Mild, moderate, or sever) Daily incidence accounted for any positive incidence AM/PM in each POD Any POD nausea/vomiting reports the incidence across day 1-3"|
1650985|NCT01690988|3038144|Superiority|||||||0.476|||||||ANOVA|||"All morphine equivalent drugs consumed by patients perioperatively~Opioid Drugs included:~* Postoperatively while still in hospital, the list of pain medication used included Morphine, Hydromorphone, Meperidine, Nalbuphine, Oxycodone,Oxymorphone, Tramadol, bupivacaine, (Codeine, Fentanyl, Naloxone) Total Opiates (Morphine Equivalent) in milligrams The median(IQR) opioid consumption was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg)"|
1650986|NCT01690988|3038145|Superiority|||||||0.964|||||||ANOVA|one-way||We compared the combined average pain level (pain level at rest, taking a deep breath, and/or when moving) over the entire day (AM and PM).|
1650987|NCT01690988|3038146|Other|Test of independence|Difference in Percentages|0.36|Standard Error of the Mean|3.301||0.912|2-Sided|95.0|-6.07|7.38|||Chi-squared||Difference in delirium incidence between placebo control and combined ketamine groups.|The primary analysis was a comparison between the placebo control group and the combined ketamine groups|
1650988|NCT01690299|3038165|Superiority or Other (legacy)||Adjusted Difference|16.7||||0.0021|2-Sided|95.0|6.5|26.9||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.||
1650989|NCT01690299|3038165|Superiority or Other (legacy)||Adjusted Difference|18.1||||0.0011|2-Sided|95.0|7.6|28.6||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.||
1650990|NCT01690299|3038166|Superiority or Other (legacy)||Difference in LS Mean|2.22||||0.1719|2-Sided|95.0|-0.75|5.19|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.|||
1650991|NCT01690299|3038166|Superiority or Other (legacy)||Difference in LS Mean|0.93||||0.7112|2-Sided|95.0|-2.05|3.9|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.|||
1650992|NCT01690299|3038167|Superiority or Other (legacy)||Difference in LS Mean|-3.94||||0.0004|2-Sided|95.0|-6.27|-1.6|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.|||
1650993|NCT01690299|3038167|Superiority or Other (legacy)||Difference in LS Mean|-4.48|||<|0.0001|2-Sided|95.0|-6.82|-2.14|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.|||
1650994|NCT01690299|3038168|Superiority or Other (legacy)||Adjusted Difference|49.8|||<|0.0001|2-Sided|95.0|36.9|62.7||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.||
1650995|NCT01690299|3038168|Superiority or Other (legacy)||Adjusted Difference|29.4|||<|0.0002|2-Sided|95.0|14.9|43.9||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.||
1650997|NCT01690299|3038169|Superiority or Other (legacy)||Difference in LS Mean|-31.4|||<|0.0001|2-Sided|95.0|-43.33|-19.46|||ANCOVA|Based on ANCOVA model with treatment and screening BMI category as factors and baseline value as a covariate.|||
1650998|NCT01690299|3038170|Superiority or Other (legacy)||Adjusted Difference|25.2|||<|0.0001|2-Sided|95.0|14.8|35.5||The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.|Cochran-Mantel-Haenszel|The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.|||
1650999|NCT01690299|3038170|Superiority or Other (legacy)||Adjusted Difference|18.0|||<|0.0005|2-Sided|95.0|8.4|27.7||The p-value is from a CMH test stratified by the BMI (Body Mass Index) at screening.|Cochran-Mantel-Haenszel|The p-value is from a CMH test stratified by the BMI at screening.|The Confidence Interval (CI) was weighted using CMH weights according to the number of participants in the two strata.||
1651000|NCT01690299|3038171|Superiority or Other (legacy)||Adjusted Difference|35.9|||<|0.0001|2-Sided|95.0|23.3|48.5||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.||
1651001|NCT01690299|3038172|Superiority or Other (legacy)||Adjusted Difference|27.5|||<|0.0001|2-Sided|95.0|14.9|40.1||The two-sided p-value is from a CMH test stratified by the BMI at screening.|Cochran-Mantel-Haenszel||The confidence interval (CI) is weighted using CMH weights according to the number of participants in the two strata.||
1651002|NCT01690273|3038173|Superiority or Other|||||||0.335|||||||Mixed Models Analysis||||
1651003|NCT01690273|3038173|Superiority or Other|||||||0.105|||||||Mixed Models Analysis||||
1651004|NCT01690273|3038173|Superiority or Other|||||||0.993|||||||Mixed Models Analysis||||
1651005|NCT01690273|3038173|Superiority or Other|||||||0.002|||||||Mixed Models Analysis||||
1651006|NCT01690273|3038173|Superiority or Other|||||||0.169|||||||Mixed Models Analysis||||
1651007|NCT01690273|3038173|Superiority or Other|||||||0.978|||||||Mixed Models Analysis||||
1651008|NCT01690273|3038174|Superiority or Other|||||||0.935|||||||Mixed Models Analysis||||
1651009|NCT01690273|3038174|Superiority or Other|||||||0.256|||||||Mixed Models Analysis||||
1651010|NCT01690273|3038174|Superiority or Other|||||||0.835|||||||Mixed Models Analysis||||
1651011|NCT01690273|3038174|Superiority or Other|||||||0.157|||||||Mixed Models Analysis||||
1651012|NCT01690273|3038174|Superiority or Other|||||||0.408|||||||Mixed Models Analysis||||
1651013|NCT01690273|3038174|Superiority or Other|||||||0.787|||||||Mixed Models Analysis||||
1651014|NCT01690273|3038175|Superiority or Other|||||||0.999|||||||Mixed Models Analysis||||
1651015|NCT01690273|3038175|Superiority or Other|||||||0.643|||||||Mixed Models Analysis||||
1651016|NCT01690273|3038175|Superiority or Other|||||||0.814|||||||Mixed Models Analysis||||
1651017|NCT01690273|3038175|Superiority or Other|||||||0.503|||||||Mixed Models Analysis||||
1651018|NCT01690273|3038175|Superiority or Other|||||||0|||||||Mixed Models Analysis||||
1651019|NCT01690273|3038175|Superiority or Other|||||||0.997|||||||Mixed Models Analysis||||
1651020|NCT01690273|3038176|Superiority or Other|||||||0.999|||||||Mixed Models Analysis||||
1651021|NCT01690273|3038176|Superiority or Other|||||||0.97|||||||Mixed Models Analysis||||
1651022|NCT01690273|3038176|Superiority or Other|||||||0.997|||||||Mixed Models Analysis||||
1651023|NCT01690273|3038176|Superiority or Other|||||||0.35|||||||Mixed Models Analysis||||
1651024|NCT01690273|3038176|Superiority or Other|||||||0|||||||Mixed Models Analysis||||
1651025|NCT01690273|3038176|Superiority or Other|||||||1|||||||Mixed Models Analysis||||
1651026|NCT01690273|3038177|Superiority or Other|||||||0.98|||||||Mixed Models Analysis||||
1651027|NCT01690273|3038177|Superiority or Other|||||||0.929|||||||Mixed Models Analysis||||
1651028|NCT01690273|3038177|Superiority or Other|||||||0.999|||||||Mixed Models Analysis||||
1651029|NCT01690273|3038177|Superiority or Other|||||||0.99|||||||Mixed Models Analysis||||
1651030|NCT01690273|3038177|Superiority or Other|||||||0.97|||||||Mixed Models Analysis||||
1651031|NCT01690273|3038177|Superiority or Other|||||||0.8|||||||Mixed Models Analysis||||
1651032|NCT01690273|3038178|Superiority or Other|||||||0.689|||||||Mixed Models Analysis||||
1651033|NCT01690273|3038178|Superiority or Other|||||||1|||||||Mixed Models Analysis||||
1651034|NCT01690273|3038178|Superiority or Other|||||||0.618|||||||Mixed Models Analysis||||
1651035|NCT01690273|3038178|Superiority or Other|||||||0.37|||||||Mixed Models Analysis||||
1651036|NCT01690273|3038178|Superiority or Other|||||||1|||||||Mixed Models Analysis||||
1651037|NCT01690273|3038178|Superiority or Other|||||||1|||||||Mixed Models Analysis||||
1651038|NCT01690273|3038179|Superiority or Other|||||||0.739|||||||Mixed Models Analysis||||
1651039|NCT01690273|3038179|Superiority or Other|||||||0.9|||||||Mixed Models Analysis||||
1651040|NCT01690273|3038179|Superiority or Other|||||||0.999|||||||Mixed Models Analysis||||
1651041|NCT01690273|3038179|Superiority or Other|||||||0.99|||||||Mixed Models Analysis||||
1651042|NCT01690273|3038179|Superiority or Other|||||||0.7|||||||Mixed Models Analysis||||
1651043|NCT01690273|3038179|Superiority or Other|||||||0.9|||||||Mixed Models Analysis||||
1651044|NCT01690273|3038180|Superiority or Other|||||||0.985|||||||Mixed Models Analysis||||
1651045|NCT01690273|3038180|Superiority or Other|||||||0.995|||||||Mixed Models Analysis||||
1651046|NCT01690273|3038180|Superiority or Other|||||||1|||||||Mixed Models Analysis||||
1651047|NCT01690273|3038180|Superiority or Other|||||||1|||||||Mixed Models Analysis||||
1651048|NCT01690273|3038180|Superiority or Other|||||||0.99|||||||Mixed Models Analysis||||
1651049|NCT01690273|3038180|Superiority or Other|||||||0.88|||||||Mixed Models Analysis||||
1651050|NCT01690273|3038181|Superiority or Other|||||||0.476|||||||Mixed Models Analysis||||
1651051|NCT01690273|3038181|Superiority or Other|||||||0.338|||||||Mixed Models Analysis||||
1651073|NCT01690273|3038184|Superiority or Other|||||||0.09|||||||Mixed Models Analysis||||
1651074|NCT01690273|3038185|Superiority or Other|||||||0.119|||||||Mixed Models Analysis||||
1651075|NCT01690273|3038185|Superiority or Other|||||||0.022|||||||Mixed Models Analysis||||
1651076|NCT01690273|3038185|Superiority or Other|||||||0.989|||||||Mixed Models Analysis||||
1651077|NCT01690273|3038185|Superiority or Other|||||||0.83|||||||Mixed Models Analysis||||
1651078|NCT01690273|3038185|Superiority or Other|||||||0.87|||||||Mixed Models Analysis||||
1651079|NCT01690273|3038185|Superiority or Other|||||||0.004|||||||Mixed Models Analysis||||
1651080|NCT01690273|3038186|Superiority or Other|||||||0.876|||||||Mixed Models Analysis||||
1651081|NCT01690273|3038186|Superiority or Other|||||||0.935|||||||Mixed Models Analysis||||
1651082|NCT01690273|3038186|Superiority or Other|||||||1|||||||Mixed Models Analysis||||
1651083|NCT01690273|3038186|Superiority or Other|||||||0.0002|||||||Mixed Models Analysis||||
1651084|NCT01690273|3038186|Superiority or Other|||||||0.0002|||||||Mixed Models Analysis||||
1651085|NCT01690273|3038186|Superiority or Other|||||||0.04|||||||Mixed Models Analysis||||
1651086|NCT01690273|3038187|Superiority or Other|||||||0.1856|||||||Mixed Models Analysis||||
1651087|NCT01690273|3038187|Superiority or Other|||||||0.0427|||||||Mixed Models Analysis||||
1651088|NCT01690273|3038187|Superiority or Other|||||||0.9913|||||||Mixed Models Analysis||||
1651089|NCT01690273|3038187|Superiority or Other|||||||0.11|||||||Mixed Models Analysis||||
1651090|NCT01690273|3038187|Superiority or Other|||||||0.99|||||||Mixed Models Analysis||||
1651091|NCT01690273|3038187|Superiority or Other|||||||0.13|||||||Mixed Models Analysis||||
1651092|NCT01690117|3038195|Superiority or Other||Mean Difference (Final Values)|7.8|Standard Error of the Mean|1.52|<|0.01|2-Sided|95.0|4.78|10.83||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651093|NCT01690117|3038196|Superiority or Other||Mean Difference (Final Values)|-4.53|Standard Error of the Mean|1.95|<|0.01|2-Sided|95.0|-8.4|-0.65||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651094|NCT01690117|3038197|Superiority or Other||Mean Difference (Final Values)|4.5|Standard Error of the Mean|1.91|<|0.05|2-Sided|95.0|0.68|8.33||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651095|NCT01690117|3038198|Superiority or Other||Mean Difference (Final Values)|2.9|Standard Error of the Mean|1.47||0.05|2-Sided|95.0|-0.01|5.81||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651096|NCT01690117|3038199|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|2.1||0.91|2-Sided|95.0|-3.96|4.45||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651097|NCT01690117|3038200|Superiority or Other||Mean Difference (Final Values)|-3.91|Standard Error of the Mean|1.98||0.05|2-Sided|95.0|-7.86|0.04||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651098|NCT01690117|3038201|Superiority or Other||Mean Difference (Final Values)|-8.49|Standard Error of the Mean|2.41|<|0.001|2-Sided|95.0|-13.31|-3.66||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651099|NCT01690117|3038202|Superiority or Other||Median Difference (Final Values)|-4.93|Standard Error of the Mean|1.92|<|0.05|2-Sided|95.0|-8.74|-1.11||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651100|NCT01690117|3038203|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|8.86||0.88|2-Sided|95.0|-2.63|2.25||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651101|NCT01690117|3038204|Superiority or Other||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|1.04|<|0.05|2-Sided|95.0|-2.5|1.62||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651102|NCT01690117|3038205|Superiority or Other||Mean Difference (Final Values)|0.97|Standard Error of the Mean|1.02||0.24|2-Sided|95.0|-0.66|2.59||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651103|NCT01690117|3038206|Superiority or Other||Mean Difference (Final Values)|0.71|Standard Error of the Mean|1.22||0.3|2-Sided|95.0|-0.65|2.07||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651104|NCT01690117|3038207|Superiority or Other||Mean Difference (Final Values)|1.7|Standard Error of the Mean|0.87||0.06|2-Sided|95.0|-0.05|3.45||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651105|NCT01690117|3038208|Superiority or Other||Mean Difference (Final Values)|2.99|Standard Error of the Mean|1.0|<|0.01|2-Sided|95.0|1.01|4.97||The a priori threshold for statistical significance was 0.05. For the secondary outcomes inference statistics were explorative. Therefore the p-value was not adjusted for multiple comparisons.|t-test, 2 sided||||
1651286|NCT01685840|3038688|Superiority|||||||0.669|||||||Mixed Models Analysis|||12 month|
1651106|NCT01690117|3038209|Superiority or Other||Mean Difference (Final Values)|5.43|Standard Error of the Mean|2.21|<|0.05|2-Sided|95.0|1.0|9.86||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided||||
1651107|NCT01690117|3038210|Superiority or Other||Mean Difference (Final Values)|7.47|Standard Error of the Mean|1.83|<|0.001|2-Sided|95.0|3.82|11.12||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided||||
1651108|NCT01690052|3038212|Superiority or Other|||||||0.05|||||||ANOVA|The p-value is calculated from the ANOVA|||
1651109|NCT01690000|3038214|Superiority or Other||||||<|0.05||||||The p-value was calculated|t-test, 2 sided|||The p-value was calculated|
1651110|NCT01689519|3038277|Superiority or Other (legacy)||Hazard Ratio (HR)|0.702||||0.005|2-Sided|95.0|0.548|0.899|||Log Rank||The analysis was stratified by geographic region and metastasis classification (disease stage).||
1651111|NCT01689519|3038279|Superiority or Other (legacy)||Mean Difference (Final Values)|22.85|||<|0.0001|2-Sided|95.0|14.13|31.58|||Chi-squared||||
1651112|NCT01689519|3038280|Superiority or Other (legacy)||Hazard Ratio (HR)|0.645||||0.0463|2-Sided|95.0|0.417|0.996||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank||||
1651113|NCT01689519|3038281|Superiority or Other (legacy)||Hazard Ratio (HR)|0.512|||<|0.0001|2-Sided|95.0|0.387|0.679||The analysis was stratified by geographic region and metastasis classification (disease stage).|Log Rank||||
1651114|NCT01689441|3038282|Superiority or Other|||||||0.54|||||||Wilcoxon (Mann-Whitney)||||
1651115|NCT01689441|3038283|Superiority or Other|||||||0.51|||||||Wilcoxon (Mann-Whitney)||||
1651116|NCT01689441|3038284|Superiority or Other|||||||0.25|||||||Wilcoxon (Mann-Whitney)||||
1651117|NCT01689350|3038299|Superiority or Other||Odds Ratio (OR)|2.69|||<|0.05|2-Sided|95.0|1.01|7.13|||Chi-squared||||
1651118|NCT01689350|3038300|Superiority or Other||Odds Ratio (OR)|4.99|||<|0.01|2-Sided|95.0|1.76|14.14|||Chi-squared|||Null hypothesis: there is no difference between the control group and experimental group in terms of frequency of leucopenia.(α=0.05） Chi-square test was applied to test the difference. The Chi-square value was 10.08 and the P-value was 0.0015, which indicated that the null hypothesis could be rejected.|
1651119|NCT01688921|3038340|Non-Inferiority or Equivalence|The safety population included subjects who received the vaccination and for whom follow-up data were available for a specific safety analysis. Therefore, the denominators for different safety tables vary, depending on the availability of the data.|||||<|0.001|||||||Fisher Exact||||
1651120|NCT01688921|3038341|Non-Inferiority or Equivalence|Immediate adverse events were reported within 30 minutes of receiving the vaccination; therefore, they are all considered related to study treatment.|||||<|0.001|||||||Fisher Exact||||
1651121|NCT01688921|3038342|Non-Inferiority or Equivalence|"Seroconversion rate was defined as the proportion of subjects with either a pre-vaccination titer of <10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer.~The upper-bound of the two-sided 95% CI on the difference in seroconversion rates for the A/H1N1, A/H3N2, and B strains did not exceed 10 percentage points (6.5, 7.1, and 5.9 respectively)."|Seroconversion Rate Difference|0.3|||||2-Sided|95.0|-5.2|5.9||||||For a sample size of 550 per group each test has an individual power of > 91% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is > 80%, computed as product of 6 individual powers.|
1651122|NCT01688921|3038343|Non-Inferiority or Equivalence|Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of <10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates(rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points|Seroconversion Rate Difference|1.3|||||2-Sided|95.0|-4.5|7.1||||||For a sample size of 550 per group each test has an individual power of > 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is > 80%, computed as product of 6 individual powers.|
1651123|NCT01688921|3038344|Non-Inferiority or Equivalence|Seroconversion rate defined as the proportion of subjects with either a pre-vaccination titer of <10 achieving a post-vaccination antibody of HI titer of ≥ 40 or with a pre-vaccination HI titer of ≥ 10 achieving a four-fold or greater increase in post-vaccination HI titer. The non-inferiority margin was defined as the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (rate with NS - with PJ Stratis) for each vaccine strain did not exceed 10 percentage points.|Seroconversion Rate Difference|0.8|||||2-Sided|95.0|-4.8|6.5||||||For a sample size of 550 per group each test has an individual power of > 95% to rule out the 10 percentage points difference using a one-sided α = 0.025, assuming equal seroconversion rates between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is > 80%, computed as product of 6 individual powers.|
1651124|NCT01688921|3038345|Non-Inferiority or Equivalence|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|0.94|||||2-Sided|95.0|0.83|1.06||||||For a sample size of 550 per group each test has an individual power of > 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is > 80%, computed as product of 6 individual powers.|
1651125|NCT01688921|3038346|Non-Inferiority or Equivalence|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|1.08|||||2-Sided|95.0|0.96|1.21||||||For a sample size of 550 per group each test has an individual power of > 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is > 80%, computed as product of 6 individual powers.|
1651150|NCT01687400|3038487|Other|||||||1|||||||Fisher Exact|||Statistical analysis #14 is for WT1 genetic mutation|
1651126|NCT01688921|3038347|Non-Inferiority or Equivalence|The non-inferiority margin was defined as the upper bound of the two-sided 95% CI of the GMT ratio (GMT with NS / GMT with PJ Stratis) for each antigen did not exceed 1.5 fold.|Geometric Mean Ratio|0.99|||||2-Sided|95.0|0.88|1.12||||||For a sample size of 550 per group each test has an individual power of > 99% to rule out the 1.5-fold difference using a two-sided α = 0.05, assuming equal GMTs between the two treatment groups. The overall power for the study to demonstrate the non-inferiority for the 6 co-primary endpoints is > 80%, computed as product of 6 individual powers.|
1651127|NCT01688739|3038379|Other||Ratio of Geometric Means|1.1||||0.5506|2-Sided|90.0|0.9|1.4|||ANCOVA||Migraine participants / Healthy participants||
1651128|NCT01688739|3038380|Other||Ratio of Geometric Means|1.1||||0.5481|2-Sided|90.0|0.9|1.4|||ANCOVA||Migraine participants / Healthy participants||
1651129|NCT01688739|3038382|Other||Ratio of Geometric Means|1.1||||0.7595|2-Sided|90.0|0.8|1.4|||ANCOVA||Migraine participants / Healthy Participants||
1651130|NCT01688050|3038442|Superiority or Other (legacy)||Device success rate (%)|96.0|||||2-Sided|95.0|90.6|100.0|||||Wald method||
1651131|NCT01688050|3038443|Superiority or Other (legacy)||Aortic injury-related mortality rate (%)|0.0|||||2-Sided|95.0|0.0|7.1|||||Exact method||
1651132|NCT01688050|3038444|Superiority or Other (legacy)||All-cause mortality rate (%)|2.0|||||2-Sided|95.0|0.0|5.88|||||Wald method||
1651133|NCT01688037|3038445|Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.2||0.0277|2-Sided|95.0|-0.8|0.0|||ANOVA||||
1651134|NCT01688037|3038445|Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.2||0.1151|2-Sided|95.0|-0.7|0.1|||ANOVA||||
1651135|NCT01688037|3038446|Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.2||0.743|2-Sided|95.0|-0.3|0.4|||ANOVA||||
1651136|NCT01688037|3038447|Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.8||0.2966|2-Sided|95.0|-2.3|0.7|||ANCOVA||||
1651137|NCT01687998|3038448|Superiority or Other (legacy)||Hazard Ratio (HR)|0.965||||0.5917|2-Sided|95.0|0.846|1.1|||Regression, Cox|||Time to First Occurrence of Triple Composite Endpoint of CV Death, MI, or Stroke|
1651138|NCT01687998|3038449|Superiority or Other (legacy)||Hazard Ratio (HR)|1.003||||0.9574|2-Sided|95.0|0.893|1.127|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA|
1651139|NCT01687998|3038450|Superiority or Other (legacy)||Hazard Ratio (HR)|1.001||||0.9874|2-Sided|95.0|0.901|1.112|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of CV Death, MI, or Coronary Revascularization|
1651140|NCT01687998|3038451|Superiority or Other (legacy)||Hazard Ratio (HR)|0.991||||0.8463|2-Sided|95.0|0.901|1.089|||Regression, Cox|||Time to First Occurrence of the Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA|
1651141|NCT01687998|3038452|Superiority or Other (legacy)||Mean Difference (Final Values)|131.55|||<|0.0001|2-Sided|95.0|130.01|133.09|||ANOVA|||HDL-C|
1651142|NCT01687998|3038452|Superiority or Other (legacy)||Mean Difference (Final Values)|-37.11|||<|0.0001|2-Sided|95.0|-38.15|-36.08|||ANOVA|||LDL-C|
1651143|NCT01687998|3038453|Superiority or Other (legacy)||Hazard Ratio (HR)|1.006||||0.9054|2-Sided|95.0|0.911|1.111|||Regression, Cox|||Primary Endpoint: Time to First Occurrence of the Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)|
1651144|NCT01687712|3038468|Superiority|Comparisons were tested against a null of zero at the two-side 5% significance level.||||||0.612||||||P-values are based upon Type III sums of squares.|ANCOVA|Treatment group and Site are included as factors.||"The null and alternative hypotheses are as follows:~H0: p2– p1 = 0 and H1: p2– p1 ≠0,~where p1 is the least squares adjusted mean number of oocytes retrieved in the AFOLIA treatment group and p2 is the least squares adjusted mean number of oocytes retrieved in the Gonal f® treatment group."|
1651145|NCT01687712|3038472|Non-Inferiority|Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF - AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (& Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.|Risk Difference (RD)|2.8|||||2-Sided|95.0|-2.5|8.1|||||"Note that risk in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF – AFOLIA."|"The null and alternative hypotheses are as follows:~H0: p2– p1 > ∆ and H1: p2– p1 ≤ ∆,~where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%."|
1651146|NCT01687712|3038473|Non-Inferiority|Non-inferiority was demonstrated if the upper limit of the two-sided 95% CI of the difference in pregnancy rates (Gonal-f® RFF – AFOLIA) did not exceed 8% (i.e. a one-sided hypothesis test at the 2.5% level of significance). The difference in rates (& Wald CI) was estimated using a logistic regression model with binomial distribution and identity link, with treatment and site as factors.|Risk Difference (RD)|3.7|||||2-Sided|95.0|-1.3|8.7|||||"Note that risk in this context is the risk of clinical pregnancy. The difference is in the direction Gonal-f® RFF – AFOLIA."|"The null and alternative hypotheses are as follows:~H0: p2– p1 > ∆ and H1: p2– p1 ≤ ∆,~where p1 is the clinical pregnancy rate in the AFOLIA treatment group, p2 is the clinical pregnancy rate in the Gonal f® treatment group, and Δ is the non-inferiority margin of 8%."|
1651147|NCT01687478|3038482|Superiority or Other (legacy)||Mean Difference (Net)|-1.62|||||2-Sided|95.0|-5.04|1.8|||||The Confidence Interval is based on the treatment difference LS Mean changes from baseline between Olanzapine + Fluoxetine and Placebo + Fluoxetine.||
1651148|NCT01687400|3038486|Superiority||Complete response rate-for current study|0.64|||<|0.0001|2-Sided|95.0|0.538|0.741|||Chi-squared|1-sample Chi-square test to compare the complete response rate to historical control (with CR=0.24)||-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 24% (13 out of 55 participants) in complete response rate.|
1651149|NCT01687400|3038486|Superiority||Overall Response Rate-for current study|0.744|||<|0.0001|2-Sided|95.0|0.652|0.836|||Chi-squared|1-sample Chi-square test to compare the overall response rate (ORR) to historical control (with ORR=0.25)||-The historical control of a 5-day regimen (Cashen et al 2010 JCO = NCT00358644) showed 25% (14 out of 55 participants) in overall response rate|
1651287|NCT01685840|3038688|Superiority|||||||0.586|||||||Mixed Models Analysis|||6 month|
1651151|NCT01687400|3038487|Other|||||||0.6|||||||Fisher Exact|||Statistical analysis #13 is for MY05B genetic mutation|
1651152|NCT01687400|3038487|Other|||||||1|||||||Fisher Exact|||-Statistical analysis #12 is for U2AF1 genetic mutation|
1651153|NCT01687400|3038487|Other|||||||0.17|||||||Fisher Exact|||Statistical analysis #11 is for NRAS genetic mutation|
1651154|NCT01687400|3038487|Other|||||||1|||||||Fisher Exact|||Statistical analysis #10 is for NPM1 genetic mutation|
1651155|NCT01687400|3038487|Other|||||||0.1|||||||Fisher Exact|||Statistical analysis #9 is for IDH1 genetic mutation|
1651156|NCT01687400|3038487|Other|||||||0.36|||||||Fisher Exact|||Statistical analysis #8 is for TET2 genetic mutation|
1651157|NCT01687400|3038487|Other|||||||0.42|||||||Fisher Exact|||Statistical analysis #7 is for RUNX1 genetic mutation|
1651158|NCT01687400|3038487|Other|||||||0.183|||||||Fisher Exact|||Statistical analysis #6 is for SF3B1 genetic mutation|
1651159|NCT01687400|3038487|Other|||||||0.3|||||||Fisher Exact|||Statistical analysis #5 is for DNMT3A genetic mutation|
1651160|NCT01687400|3038487|Other|||||||0.14|||||||Fisher Exact|||Statistical analysis #4 is for IDH2 genetic mutation|
1651161|NCT01687400|3038487|Other|||||||0.28|||||||Fisher Exact|||Statistical analysis #3 is for SRSF2 genetic mutation|
1651162|NCT01687400|3038487|Other|||||||0.72|||||||Fisher Exact|||Statistical analysis #2 is for ASXL1 genetic mutation|
1651163|NCT01687400|3038487|Other|||||||0.035|||||||Fisher Exact|||Statistical analysis #1 is for the genetic mutation TP53.|
1651164|NCT01687296|3038490|Superiority or Other|||||||0.323|||||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for investigator global evaluation|
1651165|NCT01687296|3038490|Superiority or Other|||||||0.633|||||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for participant/parent global evaluation|
1651166|NCT01687296|3038491|Superiority or Other|||||||0.7|||||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for clinical scoring index on Day 8|
1651167|NCT01687296|3038491|Superiority or Other|||||||0.507|||||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for clinical scoring index on Day 5|
1651168|NCT01687296|3038492|Superiority or Other||Mean Difference (Final Values)|-0.039||||0.384|2-Sided|95.0|-0.126|0.049|||ANCOVA|||Fluticasone propionate versus Prednisone for FVC on Day 8|
1651169|NCT01687296|3038492|Superiority or Other||Mean Difference (Final Values)|-0.067||||0.276|2-Sided|95.0|-0.187|0.054|||ANCOVA|||Fluticasone propionate versus Prednisone for FVC on Day 5|
1651170|NCT01687296|3038492|Superiority or Other||Mean Difference (Final Values)|0.004||||0.914|2-Sided|95.0|-0.074|0.083|||ANCOVA|||Fluticasone propionate versus Prednisone for FEV1 on Day 8|
1651171|NCT01687296|3038492|Superiority or Other||Mean Difference (Final Values)|-0.044||||0.348|2-Sided|95.0|-0.135|0.048|||ANCOVA|||Fluticasone propionate versus Prednisone for FEV1 on Day 5|
1651172|NCT01687296|3038493|Superiority or Other|||||||0.996|||||||Wilcoxon rank sum test||||
1651173|NCT01687296|3038494|Superiority or Other|||||||0.683|||||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for night-time symptom score|
1651174|NCT01687296|3038494|Superiority or Other|||||||0.717|||||||Wilcoxon rank sum test|||Fluticasone propionate versus Prednisone for day-time symptom score|
1651175|NCT01687296|3038495|Superiority or Other||Mean Difference (Final Values)|1.16||||0.822|2-Sided|95.0|-9.02|11.34|||ANCOVA||||
1651176|NCT01687296|3038496|Non-Inferiority or Equivalence|Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.|Mean Difference (Final Values)|0.5||||0.922|2-Sided|95.0|-9.64|10.65|||ANCOVA||||
1651177|NCT01687296|3038497|Non-Inferiority or Equivalence|Non-inferiority was demonstrated at the lower limit of the 95% confidence interval (5%, 2-sided significance level) for the treatment difference (FP minus prednisone) in the mean morning PEF on diary card over the treatment assessment period was greater than -12L/min.|Mean Difference (Final Values)|0.46||||0.931|2-Sided|95.0|-9.85|10.76|||ANCOVA|||250 par were to be enrolled to achieve 200 total evaluable par or 100 evaluable par per group. Sample size was based on the primary efficacy endpoint (AM PEF) and had 80% power to reject the null hypothesis: nebulized FP (1 mg BID) was inferior to oral prednisone with regard to AM PEF using one-side t test at significance level 2.5%, and assuming true treatment difference (FP minus predisone) was 3.6 L/min, noninferiority margin was -12L/min, and common standard deviation was 39 L/min.|
1651178|NCT01687283|3038501|Superiority or Other||Mean Difference (Net)|0.017||||0.727|2-Sided|95.0|-0.078|0.112||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction.|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 12|
1651179|NCT01687283|3038501|Superiority or Other||Mean Difference (Net)|-0.025||||0.566|2-Sided|95.0|-0.113|0.062||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 8|
1651180|NCT01687283|3038501|Superiority or Other||Mean Difference (Net)|-0.008||||0.866|2-Sided|95.0|-0.101|0.085||Repeated Measures analysis adjusted for baseline, center, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction.|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 4|
1651181|NCT01687283|3038501|Superiority or Other||Mean Difference (Net)|-0.039||||0.337|2-Sided|95.0|-0.118|0.041||Repeated Measures analysis adjusted for baseline, centre, sex, age, visit, treatment, visit by treatment interaction and visit by baseline interaction|ANCOVA|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in Change of clinical lung function measurement FEV1 at Week 2|
1651182|NCT01687283|3038502|Superiority or Other|||||||0.17|||||||Wilcoxon Rank sum||||
1651183|NCT01687283|3038503|Superiority or Other||Mean Difference (Net)|-4.74||||0.204|2-Sided|95.0|-12.07|2.59|||ANCOVA||||
1651184|NCT01687283|3038504|Superiority or Other|||||||0.949|||||||Wilcoxon rank sum test.|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in median night-time symptom score|
1651185|NCT01687283|3038504|Superiority or Other|||||||0.123|||||||Wilcoxon rank sum test|||This statistical analysis is for comparison of FP 1 mg BID and BUD 2 mg BID in median day-time symptom score|
1651186|NCT01687283|3038505|Superiority or Other||Mean Difference (Net)|0.62||||0.854|2-Sided|95.0|-6.0|7.24|||ANCOVA||||
1651187|NCT01687283|3038506|Superiority or Other||Mean Difference (Net)|-2.77||||0.579|2-Sided|95.0|-12.57|7.04|||ANCOVA||||
1651188|NCT01687283|3038507|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval for the treatment difference (FP minus BUD) in the mean change from baseline in daily AM PEF averaged over the 12 week treatment period was greater than -12 L/min.|Mean Difference (Net)|-2.28||||0.674|2-Sided|95.0|-12.95|8.38|||ANCOVA||||
1651189|NCT01687283|3038508|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the lower limit of the two-sided 95% confidence interval for the treatment difference (FP minus BUD) in the mean change from baseline in daily AM PEF averaged over the 12 week treatment period was greater than -12 L/min.|Mean Difference (Net)|-1.8||||0.733|2-Sided|95.0|-12.19|8.59||Analysis performed using ANCOVA with covariates of baseline, center, sex, age and treatment|ANCOVA||The analysis only included participants who had at least 4 days of non-missing AM PEF data in the baseline week prior to randomization and at least 4 days of non-missing AM PEF data after randomization.||
1651190|NCT01687244|3038534|Superiority or Other||HGRF survival at 12 months|36.8|||||2-Sided|90.0|18.8|58.2|||||The proportion of subjects achieving high-grade recurrence-free survival at 12 months|The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion.|
1651191|NCT01687244|3038534|Superiority or Other||HGRF survival at 12 months|33.3|||||2-Sided|90.0|16.8|53.6||||||The primary efficacy endpoint was the incidence of high-grade recurrence-free survival at 12 months. The proportion of patients achieving high-grade recurrence-free survival at 12 months was reported for each dose group, together with an exact 90% confidence interval for the proportion|
1651192|NCT01687218|3038542|Superiority||Odds Ratio (OR)|0.89||||0.74|2-Sided|95.0|0.43|1.81|||Generalized Estimating Equations (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into<80% adherence versus>80% adherence.|
1651193|NCT01687218|3038542|Superiority||Odds Ratio (OR)|0.35||||0.0005|2-Sided|95.0|0.19|0.63|||Generalized Estimating Equations (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables was used to compare the three treatment regimens for the acceptability endpoints. Because the distribution of the adherence percentages were skewed, we did not use a linear mixed effects model as originally planned. Instead, we dichotomized the adherence percentage into<80% adherence versus>80% adherence.|
1651194|NCT01687218|3038543|Superiority||Slope|0.01||||0.92|2-Sided|95.0|-0.28|0.31|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.|
1651195|NCT01687218|3038543|Superiority||Slope|0.54|||<|0.001|2-Sided|95.0|0.35|0.72|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.|
1651196|NCT01687218|3038544|Superiority||Slope|-1.9|||<|0.001|2-Sided|95.0|-2.07|-1.74|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.|
1651197|NCT01687218|3038544|Superiority||Slope|-2.0|||<|0.001|2-Sided|95.0|-2.16|-1.84|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only are used in this analysis.|
1651198|NCT01687218|3038545|Superiority||Slope|-0.91|||<|0.001|2-Sided|95.0|-1.01|-0.8|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.|
1651199|NCT01687218|3038545|Superiority||Slope|-0.91|||<|0.001|2-Sided|95.0|-1.01|-0.8|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. End period visits only are used in this analysis.|
1651200|NCT01687218|3038546|Superiority||Slope|-2.65|||<|0.001|2-Sided|95.0|-2.81|-2.49|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.|
1651201|NCT01687218|3038546|Superiority||Slope|-2.66|||<|0.001|2-Sided|95.0|-2.82|-2.5|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality for the following analysis.|
1651202|NCT01687218|3038547|Superiority||Slope|-0.7|||<|0.001|2-Sided|95.0|-0.92|-0.47|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.|
1651203|NCT01687218|3038547|Superiority||Slope|0.3|||<|0.004|2-Sided|95.0|0.1|0.5|||Mixed Models Analysis|||Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality. Mid period and end period visits only were used in this analysis.|
1651204|NCT01687218|3038548|Superiority||Slope|-0.16||||0.31|2-Sided|95.0|-0.46|0.15|||Mixed Models Analysis||Oral regimen is the reference group.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.|
1651205|NCT01687218|3038548|Superiority||Slope|0.66|||<|0.001|2-Sided|95.0|0.49|0.83|||Mixed Models Analysis||Oral regimen is the reference group.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.|
1651206|NCT01687218|3038549|Other||Slope|-1.82|||<|0.001|2-Sided|95.0|-1.95|-1.7|||Mixed Models Analysis||This comparison is between the RAI rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.|
1651207|NCT01687218|3038549|Other||Slope|-1.41|||<|0.001|2-Sided|95.0|-1.53|-1.3|||Mixed Models Analysis||This comparison is between the daily rectal and oral (reference) groups for tenofovir levels in blood plasma, log10 ng/mL.|Mixed effects models were used to compare the three treatment regimens within participants over time using the oral regimen as the reference group. The models included fixed effects for treatment regimen and period and random effects for participant within sequence. The log 10 transformation was used in the mixed effects models for all PK results to achieve normality.|
1651208|NCT01687218|3038550|Superiority or Other (legacy)||Odds Ratio (OR)|0.7||||0.23|2-Sided|95.0|0.39|1.25|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.|
1651209|NCT01687218|3038550|Superiority or Other (legacy)||Odds Ratio (OR)|0.38||||0.0004|2-Sided|95.0|0.22|0.65|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.|
1651210|NCT01687218|3038551|Superiority or Other (legacy)||Odds Ratio (OR)|0.76||||0.46|2-Sided|95.0|0.37|1.56|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.|
1651211|NCT01687218|3038551|Superiority or Other (legacy)||Odds Ratio (OR)|0.56||||0.08|2-Sided|95.0|0.29|1.08|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.|
1651212|NCT01687218|3038552|Superiority or Other (legacy)||Odds Ratio (OR)|0.37||||0.002|2-Sided|95.0|0.2|0.7|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.|
1651213|NCT01687218|3038552|Superiority or Other (legacy)||Odds Ratio (OR)|0.28|||<|0.0001|2-Sided|95.0|0.15|0.5|||Generalized Estimating Equation (GEE)||Oral regimen is the reference group.|Generalized Estimating Equation (GEE) models with a binomial (logit) link, an exchangeable correlation structure and robust errors and with treatment regimen and period as independent variables were used to compare the three treatment regimens for the acceptability endpoints. The oral arm and period 1 were used as the reference group in each of the models.|
1651240|NCT01686633|3038623|Superiority or Other||Mean Difference (Final Values)|0.108|||<|0.001|2-Sided|95.0|0.045|0.171|||ANCOVA||||
1651284|NCT01685840|3038687|Superiority||Mean Difference (Final Values)|0.88||||0.404|2-Sided|95.0|-1.188|2.947||Adjusted P‐value|Mixed Models Analysis|||3 month|
1651285|NCT01685840|3038688|Superiority|||||||0.949|||||||Mixed Models Analysis|||24 month|
1651214|NCT01687218|3038553|Superiority or Other (legacy)||Risk Ratio (RR)|0.88||||0.43|2-Sided|95.0|0.64|1.21|||Generalized Estimating Equation (GEE)||It shows the rate ratio (RR) based on a GEE model comparing the RAI Rectal regimen with the Oral regimen and controlling for period in the model.|Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.|
1651215|NCT01687218|3038553|Superiority or Other (legacy)||Risk Ratio (RR)|1.03||||0.88|2-Sided|95.0|0.73|1.44|||Generalized Estimating Equation (GEE)||It shows the rate ratio (RR) based on a GEE model comparing the Daily Rectal regimen with the Oral regimen and controlling for period in the model.|Since some participants have more than one safety event per period of treatment regimen, a Generalized Estimating Equation (GEE) model with a Poisson (log) link, exchangeable correlation structure, and robust standard errors were used.|
1651216|NCT01686958|3038577|Other|This is a primarily descriptive study, no statistical analysis is planned; however, analyses were performed at the alpha=0.05 level of significance and exact analyses will be used wherever possible.||||||||||||||||A total of 30 subjects will be accrued to this study and treated with the PAD-105. The sample size is based primarily on feasibility and logistical concerns, however, is sufficiently large to allow the safety objectives to be met. Specifically, with 30 total patients, if no treatment-related grade 4 or 5 adverse events are observed, then a one-sided, 95% confidence interval would have an upper bound of 0.095.|For continuous outcomes, standard summary statistics will include n, mean, standard deviation, median, minimum and maximum. For categorical data, tables will show n and % of patients.
1651217|NCT01686828|3038589|Other||||||>|0.1|||||||ANOVA|||The null hypothesis was that short-term testosterone deprivation would not affect lipoprotein lipase expression in adipose tissue. Repeated measures ANOVA was used to determine if a time-by-group effect was apparent for lipoprotein lipase expression.|
1651218|NCT01686828|3038590|Superiority or Other|||||||0.03||||||Time-by-group interaction for lean mass|RM-ANOVA||||
1651219|NCT01686828|3038590|Superiority or Other|||||||0.003|||||||RM-ANOVA|||Time-by-group interaction for fat mass|
1651220|NCT01686828|3038591|Superiority or Other|||||||0.164||||||The a prior threshold for statistical significance was p<0.05.|RM-ANOVA||||
1651221|NCT01686750|3038592|Superiority||Risk Ratio (RR)|0.93|||||2-Sided|95.0|0.64|1.36|||||||
1651222|NCT01686750|3038593|Superiority||Mean Difference (Final Values)|-1.8|||||2-Sided|95.0|-3.0|-0.6|||||||
1651223|NCT01686750|3038595|Superiority||Risk Ratio (RR)|0.84|||||2-Sided|95.0|0.47|1.52|||||||
1651224|NCT01686750|3038597|Superiority||Mean Difference (Final Values)|0.03|||||2-Sided|95.0|-4.2|4.2|||||||
1651225|NCT01686750|3038598|Superiority||Risk Ratio (RR)|0.91|||||2-Sided|95.0|0.53|1.56|||||||
1651226|NCT01686750|3038599|Superiority||Risk Ratio, log|1.87|||||2-Sided|95.0|0.49|7.16|||||||
1651227|NCT01686750|3038600|Superiority||Risk Ratio, log|1.44|||||2-Sided|95.0|0.42|4.93|||||||
1651228|NCT01686750|3038602|Superiority||Risk Ratio (RR)|0.91|||||2-Sided|95.0|0.65|1.28|||||||
1651229|NCT01686750|3038604|Superiority||Risk Ratio (RR)|1.36|||||2-Sided|95.0|0.77|2.41|||||||
1651230|NCT01686750|3038605|Superiority||Risk Ratio (RR)|1.05|||||2-Sided|95.0|0.61|1.81|||||||
1651231|NCT01686750|3038606|Superiority||Risk Ratio (RR)|1.08|||||2-Sided|95.0|0.8|1.5|||||||
1651232|NCT01686750|3038607|Superiority||Risk Ratio (RR)|1.31||||0.09|2-Sided|95.0|0.95|1.81|||Prevalence ratio||Therefore, the exponentiated coefficients for intervention status represent the prevalence ratio with 95% confidence interval (CI) and are interpreted as the relative percentage difference in the outcome associated with the intervention.|We compared the sampling-weighted prevalence of outcomes at Integrated Care Centers (ICCs) and usual care from the evaluation survey. We used linear regression models that had terms for intervention status (integrated care vs usual care), stratum (PWID and MSM), and the baseline proportion of the outcome being assessed. Site-level proportions from both evaluation and baseline respondent-driven sampling were log transformed before being entered into the regression model.|
1651233|NCT01686646|3038616|Superiority or Other||LS Mean Difference|1.1|||||2-Sided|95.0|-1.7|3.9|||||A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.|
1651234|NCT01686646|3038616|Superiority or Other||LS Mean Difference|2.7|||||2-Sided|95.0|0.3|5.2|||||A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.|
1651235|NCT01686646|3038616|Superiority or Other||LS Mean Difference|2.9||||0.0696|2-Sided|95.0|-0.2|6.1||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of accurate responses from the RVIP.|
1651236|NCT01686646|3038617|Superiority or Other||LS Mean Difference|3.9|||||2-Sided|95.0|1.1|6.6|||||A positive difference favoured the first named treatment.|Null hypothesis was no difference in treatments in change from baseline in number of valid responses from RVIP task.|
1651237|NCT01686646|3038617|Superiority or Other||LS Mean Difference|1.7||||0.1513|2-Sided|95.0|-0.6|4.1||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favoured the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.|
1651238|NCT01686646|3038617|Superiority or Other||LS Mean DIfference|3.5||||0.0248|2-Sided|95.0|0.4|6.5||A hierarchical testing procedure was used such that p-values were only presented if the preceding treatment comparison was statistically significant (p<0.05).|ANCOVA|From ANCOVA model with factors for treatment group and season, and baseline score as a covariate.|A positive difference favored the first named treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.|
1651239|NCT01686633|3038623|Superiority or Other||Mean Difference (Final Values)|0.024|||||2-Sided|95.0|-0.037|0.086|||||||
1651241|NCT01686438|3038662|Non-Inferiority|The mean change in ISI score from baseline in Veterans receiving CBT-I by video teleconferencing will be no more than 1.67 smaller than the reference treatment, i.e., Veterans receiving in-person CBT-I.|Mean Difference (Net)|-2.03|Standard Deviation|1.33||0.138|2-Sided|95.0|-4.63|1.57|||t-test, 1 sided||||
1651242|NCT01685840|3038677|Superiority|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Total Cost|
1651243|NCT01685840|3038677|Superiority|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||Physician Fees|
1651244|NCT01685840|3038677|Superiority|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Hospital Costs|
1651245|NCT01685840|3038678|Superiority|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Total admissions|
1651246|NCT01685840|3038678|Superiority|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Rehab facilities|
1651247|NCT01685840|3038678|Superiority|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||ER only events|
1651248|NCT01685840|3038678|Superiority|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Hospitalizations|
1651249|NCT01685840|3038679|Superiority||Mean Difference (Final Values)|0.322||||0.903|2-Sided|95.0|-4.894|5.538||Adjusted P-value|Mixed Models Analysis|||24 month|
1651250|NCT01685840|3038679|Superiority||Mean Difference (Final Values)|0.904||||0.647|2-Sided|95.0|-2.973|4.782||Adjusted P-value|Mixed Models Analysis|||12 month|
1651251|NCT01685840|3038679|Superiority||Mean Difference (Final Values)|0.28||||0.882|2-Sided|95.0|-3.409|3.969||Adjusted P-value|Mixed Models Analysis|||6 month|
1651252|NCT01685840|3038679|Superiority||Mean Difference (Final Values)|0.017||||0.992|2-Sided|95.0|-3.383|3.417||Adjusted P-value|Mixed Models Analysis|||3 month|
1651253|NCT01685840|3038680|Superiority||Mean Difference (Final Values)|2.857||||0.488|2-Sided|95.0|-5.247|10.961||Adjusted P-value|Mixed Models Analysis|||24 month|
1651254|NCT01685840|3038680|Superiority||Mean Difference (Final Values)|6.564||||0.035|2-Sided|95.0|0.456|12.673||Adjusted P-value|Mixed Models Analysis|||12 month|
1651255|NCT01685840|3038680|Superiority||Mean Difference (Final Values)|1.966||||0.497|2-Sided|95.0|-3.715|7.647||Adjusted P-value|Mixed Models Analysis|||6 months|
1651256|NCT01685840|3038680|Superiority||Mean Difference (Final Values)|1.057||||0.696|2-Sided|95.0|-4.25|6.364||Adjusted P‐value|Mixed Models Analysis|||3 month|
1651257|NCT01685840|3038681|Superiority||Mean Difference (Final Values)|2.512||||0.475|2-Sided|95.0|-4.394|9.419||Adjusted P-value|Mixed Models Analysis|||24 month|
1651258|NCT01685840|3038681|Superiority||Mean Difference (Final Values)|-1.539||||0.567|2-Sided|95.0|-6.81|3.732||Adjusted P-value|Mixed Models Analysis|||12 month|
1651259|NCT01685840|3038681|Superiority||Mean Difference (Final Values)|-2.693||||0.288|2-Sided|95.0|-7.662|2.276||Adjusted P-value|Mixed Models Analysis|||6 month|
1651260|NCT01685840|3038681|Superiority||Mean Difference (Final Values)|-0.484||||0.837|2-Sided|95.0|-5.102|4.133||Adjusted P-value|Mixed Models Analysis|||3 month|
1651261|NCT01685840|3038682|Superiority||Mean Difference (Final Values)|-0.647||||0.757|2-Sided|95.0|-4.767|3.472||Adjusted P‐value|Mixed Models Analysis|||24 month|
1651262|NCT01685840|3038682|Superiority||Mean Difference (Final Values)|-0.798||||0.643|2-Sided|95.0|-4.178|2.583||Adjusted P‐value|Mixed Models Analysis|||12 month|
1651263|NCT01685840|3038682|Superiority||Mean Difference (Final Values)|-0.946||||0.555|2-Sided|95.0|-4.096|2.203||Adjusted P‐value|Mixed Models Analysis|||6 month|
1651264|NCT01685840|3038682|Superiority||Mean Difference (Final Values)|-1.579||||0.294|2-Sided|95.0|-4.527|1.369||Adjusted P‐value|Mixed Models Analysis|||3 month|
1651265|NCT01685840|3038683|Superiority||Mean Difference (Final Values)|1.478||||0.294|2-Sided|95.0|-1.286|4.241||Adjusted P-value|Mixed Models Analysis|||24 month|
1651266|NCT01685840|3038683|Superiority||Mean Difference (Final Values)|-0.074||||0.943|2-Sided|95.0|-2.119|1.97||Adjusted P‐value|Mixed Models Analysis|||12 month|
1651267|NCT01685840|3038683|Superiority||Mean Difference (Final Values)|-0.742||||0.465|2-Sided|95.0|-2.735|1.25|||Mixed Models Analysis|||6 month|
1651268|NCT01685840|3038683|Superiority||Mean Difference (Final Values)|-1.226||||0.199|2-Sided|95.0|-3.097|0.645||Adjusted P‐value|Mixed Models Analysis|||3 month|
1651269|NCT01685840|3038684|Superiority||Mean Difference (Final Values)|1.091||||0.653|2-Sided|95.0|-3.673|5.856||Adjusted P-value|Mixed Models Analysis|||24 month|
1651270|NCT01685840|3038684|Superiority||Mean Difference (Final Values)|-1.406||||0.441|2-Sided|95.0|-4.989|2.178||Adjusted P-value|Mixed Models Analysis|||12 month|
1651271|NCT01685840|3038684|Superiority||Mean Difference (Final Values)|0.252||||0.878|2-Sided|95.0|-2.977|3.482||Adjusted P‐value|Mixed Models Analysis|||6 month|
1651272|NCT01685840|3038684|Superiority||Mean Difference (Final Values)|-0.816||||0.615|2-Sided|95.0|-3.999|2.367||Adjusted P‐value|Mixed Models Analysis|||3 month|
1651273|NCT01685840|3038685|Superiority||Mean Difference (Final Values)|-3.343||||0.221|2-Sided|95.0|-8.708|2.022||Adjusted P‐value|Mixed Models Analysis|||24 month|
1651274|NCT01685840|3038685|Superiority||Mean Difference (Final Values)|-0.389||||0.852|2-Sided|95.0|-4.486|3.707||Adjusted P‐value|Mixed Models Analysis|||12 month|
1651275|NCT01685840|3038685|Superiority||Mean Difference (Final Values)|1.069||||0.599|2-Sided|95.0|-2.921|5.058|||Mixed Models Analysis|||6 month|
1651276|NCT01685840|3038685|Superiority||Mean Difference (Final Values)|-2.131||||0.268|2-Sided|95.0|-5.902|1.64||Adjusted P‐value|Mixed Models Analysis|||3 month|
1651277|NCT01685840|3038686|Superiority||Mean Difference (Final Values)|0.009||||0.78|2-Sided|95.0|-0.057|0.076||Adjusted P‐value|Mixed Models Analysis|||24 month|
1651278|NCT01685840|3038686|Superiority||Mean Difference (Final Values)|0.021||||0.402|2-Sided|95.0|-0.028|0.07|||Mixed Models Analysis|||12 month|
1651279|NCT01685840|3038686|Superiority||Mean Difference (Final Values)|0.028||||0.239|2-Sided|95.0|-0.018|0.074||Adjusted P‐value|Mixed Models Analysis|||6 month|
1651280|NCT01685840|3038686|Superiority||Mean Difference (Final Values)|0.017||||0.421|2-Sided|95.0|-0.025|0.06||Adjusted P‐value|Mixed Models Analysis|||3 month|
1651281|NCT01685840|3038687|Superiority||Mean Difference (Final Values)|1.999||||0.228|2-Sided|95.0|-1.253|5.25|||Mixed Models Analysis|||24 month|
1651282|NCT01685840|3038687|Superiority||Mean Difference (Final Values)|2.099||||0.104|2-Sided|95.0|-0.433|4.63||Adjusted P-value|Mixed Models Analysis|||12 month|
1651283|NCT01685840|3038687|Superiority||Mean Difference (Final Values)|1.478||||0.219|2-Sided|95.0|-0.881|3.836||Adjusted P‐value|Mixed Models Analysis|||6 month|
1651288|NCT01685840|3038688|Superiority|||||||0.628|||||||Mixed Models Analysis|||3 month|
1651289|NCT01685840|3038688|Superiority|||||||0.636|||||||Mixed Models Analysis|||Baseline|
1651290|NCT01685840|3038689|Superiority or Other||Hazard Ratio (HR)|1.29||||0.08|2-Sided|95.0|0.97|1.72|||Anderson-Gill Intensity Model||||
1651291|NCT01685840|3038690|Superiority or Other||Hazard Ratio (HR)|1.04||||0.76|2-Sided|95.0|0.82|1.31|||Regression, Cox||||
1651292|NCT01685840|3038691|Superiority or Other||Hazard Ratio (HR)|0.94||||0.75|2-Sided|95.0|0.65|1.37|||Regression, Cox||||
1651293|NCT01685840|3038692|Superiority or Other||Mean Difference (Net)|9.0||||0.53|2-Sided|95.0|-20.0|39.0|||Bang-Tsiatis Partitioned Estimator||||
1651294|NCT01685840|3038693|Superiority or Other||Cox Proportional Hazard|0.86||||0.37|2-Sided|95.0|0.62|1.2|||Regression, Cox||||
1651295|NCT01685840|3038694|Superiority or Other||Hazard Ratio (HR)|0.98||||0.88|2-Sided|95.0|0.79|1.22||A sample size of 1100 patients was expected to provide approximately 90% power to detect a difference in the primary endpoint with an assumed type I error rate of 0.05, 2-sided. Analysis was adjusted for age, sex, ejection fraction, NT-proBNP and DM.|Regression, Cox||||
1651296|NCT01685801|3038701|Superiority or Other||Posterior Mean|2.251|Standard Deviation|0.961|||2-Sided|95.0|0.383|4.144|||||The posterior distribution of overall treatment difference was obtained using the Bayesian hierarchical model and 95% credible interval of the treatment effect (posterior mean) was calculated.|This statistical analysis is for “Overall” category.|
1651297|NCT01685684|3038711|Superiority or Other||Marginal Mean Difference (Net)|-1.56|Standard Error of the Mean|0.267|<|0.0001|2-Sided||||||z-test||||
1651298|NCT01685203|3038789|Superiority or Other|||||||0.086||||||Difference in rates after adjusting for Interleukin-28 (IL28) genotype (CC or Non-CC) using stratum-adjusted Mantel-Haenszel proportions and continuity-corrected variances.|Stratum-adjusted Mantel-Haenszel||||
1651299|NCT01685203|3038789|Superiority or Other|||||||0.381|||||||Regression, Logistic|Treatment group, baseline log(subscript)10(subscript) HCV RNA level and Interleukin-28B (IL28B) genotype (CC or non-CC) were used as predictors|||
1651300|NCT01685047|3038816|Other|There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Datasets (Device info at Baseline versus 15 minutes prior to the event) were compared using a 2-sided t-test.|||||<|0.05||||||All events with p <0.05 were visually inspected to confirm they were evaluable; additional criteria for exclusion from further analysis included inappropriate therapy, aberrant conduction, and occurrence of VT/VF within 24h prior to the event.|t-test, 2 sided|||There were no formal pre-specified statistical hypotheses for the endpoints of the study due to the exploratory nature of this study. Some data was excluded from the primary analysis. All device detections resulting in therapy have been reviewed for appropriateness of the therapy. VT/VF therapy delivered from the device as a result of a non-ventricular arrhythmia or as a result of oversensing by the device has not been included in the primary data analysis.|
1651301|NCT01684917|3038835|Superiority|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."|
1651302|NCT01684917|3038837|Superiority||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks|
1651303|NCT01684917|3038837|Superiority||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks|
1651304|NCT01684917|3038837|Superiority||||||<|0.05||||||The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks|
1651305|NCT01684917|3038838|Superiority|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."|
1651306|NCT01684917|3038839|Superiority|"Statistical Analysis was performed only for the Diet Arm/Group"|||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||"Baseline vs 12 weeks. Statistical Analysis was performed only for the Diet Arm/Group."|
1651307|NCT01684917|3038840|Superiority||||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance.|t-test, 2 sided|||Baseline vs 12 weeks|
1651308|NCT01684917|3038840|Superiority||||||<|0.05||||||calculated. The reported p-value was calculated, and is not attempting to indicate the threshold for statistical significance|t-test, 2 sided|||Baseline vs 12 weeks|
1651309|NCT01684878|3038841|Superiority or Other||Hazard ratio (stratified)|0.9||||0.596|2-Sided|95.0|0.61|1.32|||2 sided log-rank||A hazard ratio < 1 favored the Pertuzumab + Chemotherapy treatment group|The stratified time-to-event analysis included the treatment group variable plus the following stratification factors: selected chemotherapy cohort (gemcitabine versus topotecan versus paclitaxel), previous angiogenic therapy (yes versus no) and PFI since platinum therapy (<3 months versus 3-6 months).|
1651310|NCT01684878|3038846|Superiority or Other||Difference in response rate|6.06||||0.4102|2-Sided|95.0|6.0|18.3|||Fisher Exact||Approximate 95% CI for difference of 2 rates using Hauck-Anderson method.||
1651311|NCT01684878|3038848|Superiority or Other||Hazard Ratio (stratified)|0.88||||0.4983|2-Sided|95.0|0.62|1.27|||2 sided log-rank|||The stratified time-to-event analysis included the treatment group variable plus the following stratification factors: selected chemotherapy cohort (gemcitabine versus topotecan vs paclitaxel), previous anti-angiogenic therapy (yes versus no), and progression-free interval (PFI) since platinum therapy (< 3 months versus 3-6 months). A hazard ratio < 1 favored the pertuzumab + chemotherapy treatment arm.|
1651312|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (total omega-3) between groups (LCPUFA vs. Placebo).|
1651483|NCT01681472|3039247|Other||Correlation factor|-0.16724||||0.6922|2-Sided||||||Pearson Correlation|||Correlation for ABCC1 gene expression|
1651313|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (Total Omega-6) between groups (LCPUFA vs. Placebo).|
1651314|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.001||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:6n-3 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651315|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.71||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (22:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651316|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.001||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:5n-3 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651317|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.1||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:4n-6 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651318|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.07||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (20:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651319|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.5||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:4n-3 nmol/mL ) between groups (LCPUFA vs. Placebo).|
1651320|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.24||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-3 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651321|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.34||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:3n-6 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651322|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.21||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:2n-6 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651323|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:1n-9 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651324|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (18:0 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651325|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.16||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:1n-7 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651326|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.02||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (16:0 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651327|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.38||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (14:0 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651328|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.47||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (12:0 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651329|NCT01683565|3038992|Other|Differences in mean changes in erythrocyte fatty acid composition were examined using t-tests.||||||0.31||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|||The reported p-value is for the comparison of the change in erythrocyte fatty acid composition (10:0 nmol/mL) between groups (LCPUFA vs. Placebo).|
1651330|NCT01683565|3038993|Other|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.07|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Red Flag scores between groups (LCPUFA vs. Placebo).|
1651347|NCT01682876|3039057|Superiority or Other||Risk Ratio (RR)|1.14|||||2-Sided|95.0|0.48|2.68||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM|
1652398|NCT01672970|3040368|Superiority or Other|||||||0|||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6|
1651331|NCT01683565|3038993|Other|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.03|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Austism Spectrum Disorder scores between groups (LCPUFA vs. Placebo).|
1651332|NCT01683565|3038993|Other|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.91|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Internalizing scores between groups (LCPUFA vs. Placebo).|
1651333|NCT01683565|3038993|Other|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.23|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Externalizing scores between groups (LCPUFA vs. Placebo).|
1651334|NCT01683565|3038993|Other|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.88|||||||Mixed Models Analysis|||The reported p-value is for the comparison of the change in Dysregulation scores between groups (LCPUFA vs. Placebo).|
1651335|NCT01683565|3038993|Other|Analyses compared the change in the BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes||||||0.92||||||Threshold for statistical significance (<0.05).|Mixed Models Analysis|||The reported p-value is for the comparison of the change in Problem scores between groups (LCPUFA vs. Placebo).|
1651336|NCT01683565|3038993|Other|Analyses compared the change in BITSEA outcome scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect; no participant characteristics were included as covariates in the models. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.22||||||Threshold for statistical significance (<0.05).|Mixed Models Analysis|||The reported p-value is for the comparison of the change in Competence scores between groups (LCPUFA vs. Placebo).|
1651337|NCT01683565|3038994|Other|Analyses compared the change in Pervasive Developmental Disorders Screening Test-II scores between groups, controlling for baseline scores, using mixed effects regression. This method leverages maximum likelihood to account for missing data. Treatment-by-time interaction terms were included as fixed effects and served as estimates of treatment effect. Group mean differences divided by the standard deviation were also calculated as effect sizes.||||||0.67||||||Threshold for statistical significance (<0.05)|Mixed Models Analysis|||The sample size was determined based on the goal of confirming trial feasibility and estimating effect sizes for a full-scale trial, not for a definitive test of efficacy. The enrollment goal was 40, which would have provided an indication of an expected effect size for a larger full-scale trial (e.g., 53% power to detect a 2-point decrease (approximately 0.7-SD based on a prior study) in Pervasive Developmental Disorders Screening Test-II score). Funding limitations capped enrollment at 31.|
1651338|NCT01683383|3039006|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1651339|NCT01683383|3039008|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)||||
1651340|NCT01683383|3039009|Superiority or Other||||||<|0.001|||||||Adjusted Wald estimation||||
1651341|NCT01683331|3039011|Superiority||Odds Ratio (OR)|1.3||||0.92|2-Sided|95.0|1.2|2.8|||Chi-squared||||
1651342|NCT01683331|3039012|Superiority||Odds Ratio (OR)|1.03||||0.87|2-Sided|95.0|1.01|1.06|||Chi-squared||||
1651343|NCT01683266|3039021|Superiority or Other||LS Mean difference|-0.35|Standard Error of the Mean|0.322|||2-Sided|95.0|-0.982|0.287||||||Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (<8.0, >=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; pre-injection SMPG value and pre-injection SMPG value-by-visit interaction as continuous fixed covariates.|
1651344|NCT01683266|3039024|Non-Inferiority or Equivalence|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is <0.4%.~Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is <0."|Least Squares (LS) Mean difference|0.04|Standard Error of the Mean|0.072|||2-Sided|95.0|-0.098|0.185||||||Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (<8.0, >=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.|
1651345|NCT01682954|3039051|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1651346|NCT01682954|3039052|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1651481|NCT01681472|3039247|Other||Correlation factor|0.74757||||0.033|2-Sided||||||Pearson Correlation|||Correlation for ABCC1 gene expression|
1651348|NCT01682876|3039057|Superiority or Other||Risk Ratio (RR)|1.83|||||2-Sided|95.0|1.22|2.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced headache in the two doses versus in the one dose of MenACWY-CRM|
1651349|NCT01682876|3039057|Superiority or Other||Risk Ratio (RR)|2.07|||||2-Sided|95.0|0.97|4.42||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced arthralgia in the two doses versus in the one dose of MenACWY-CRM|
1651350|NCT01682876|3039057|Superiority or Other||Risk Ratio (RR)|1.37|||||2-Sided|95.0|0.99|1.89||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced myalgia in the two doses versus in the one dose of MenACWY-CRM|
1651351|NCT01682876|3039057|Superiority or Other||Risk Ratio (RR)|1.65|||||2-Sided|95.0|1.06|2.57||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fatigue in the two doses versus in the one dose of MenACWY-CRM|
1651352|NCT01682876|3039057|Superiority or Other||Risk Ratio (RR)|1.29|||||2-Sided|95.0|0.77|2.17||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced nausea in the two doses versus in the one dose of MenACWY-CRM|
1651353|NCT01682876|3039057|Superiority or Other||Risk Ratio (RR)|1.81|||||2-Sided|95.0|0.98|3.33||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced loss of appetite in the two doses versus in the one dose of MenACWY-CRM|
1651354|NCT01682876|3039057|Superiority or Other||Risk Ratio (RR)|1.27|||||2-Sided|95.0|1.04|1.55||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced pain in the two doses versus in the one dose of MenACWY-CRM|
1651355|NCT01682876|3039057|Superiority or Other||Risk Ratio (RR)|1.49|||||2-Sided|95.0|0.81|2.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM|
1651356|NCT01682876|3039057|Superiority or Other||Risk Ratio (RR)|1.43|||||2-Sided|95.0|0.77|2.65||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM|
1651357|NCT01682876|3039058|Superiority or Other||Risk Ratio (RR)|0.75|||||2-Sided|95.0|0.33|1.74||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM|
1651358|NCT01682876|3039058|Superiority or Other||Risk Ratio (RR)|1.03|||||2-Sided|95.0|0.74|1.43||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced irritability in the two doses versus in the one dose of MenACWY-CRM|
1651359|NCT01682876|3039058|Superiority or Other||Risk Ratio (RR)|1.08|||||2-Sided|95.0|0.76|1.52||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced sleepiness in the two doses versus in the one dose of MenACWY-CRM|
1651360|NCT01682876|3039058|Superiority or Other||Risk Ratio (RR)|0.88|||||2-Sided|95.0|0.54|1.42||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced change in eating habits in the two doses versus in the one dose of MenACWY-CRM|
1651361|NCT01682876|3039058|Superiority or Other||Risk Ratio (RR)|1.07|||||2-Sided|95.0|0.85|1.34||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced tenderness in the two doses versus in the one dose of MenACWY-CRM|
1651362|NCT01682876|3039058|Superiority or Other||Risk Ratio (RR)|2.75|||||2-Sided|95.0|1.18|6.36||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM|
1651363|NCT01682876|3039058|Superiority or Other||Risk Ratio (RR)|2.3|||||2-Sided|95.0|1.17|4.53||||||The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM|
1651364|NCT01682876|3039063|Superiority or Other||Vaccine group Differences at Day 86|29.0|||||2-Sided|98.75|17.0|39.6||||||Superiority for age cohort (6 through 10 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY|
1651365|NCT01682876|3039063|Superiority or Other||Vaccine Group Differences at Day 86|5.0|||||2-Sided|98.75|-8.4|18.8||||||Superiority for age cohort (6 through 10 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW|
1651366|NCT01682876|3039063|Superiority or Other||Vaccine Group differences at Day 86|18.0|||||2-Sided|97.5|9.5|27.1||||||Superiority for age cohort (6 through 10 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC|
1651367|NCT01682876|3039063|Superiority or Other||Vaccine groups differences at Day 86|11.0|||||2-Sided|98.75|1.0|21.2||||||Superiority for age cohort (6 through 10 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA|
1651368|NCT01682876|3039063|Superiority or Other||Vaccine groups Differences at Day 86|28.0|||||2-Sided|98.75|16.2|39.3||||||Superiority for age cohort (2 through 5 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY|
1651369|NCT01682876|3039063|Superiority or Other||Vaccine Group differences at Day 86|14.0|||||2-Sided|98.75|1.0|27.1||||||Superiority for age cohort (2 through 5 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW|
1651370|NCT01682876|3039063|Superiority or Other||Vaccine Group Differences at Day 86|28.0||||||98.75|17.1|38.7||||||Superiority for age cohort (2 through 5 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC|
1651371|NCT01682876|3039063|Superiority or Other||Vaccine Group Differences at Day 86|18.0|||||2-Sided|98.75|9.1|28.0||||||Superiority for age cohort (2 through 5 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA|
1651372|NCT01682876|3039064|Non-Inferiority or Equivalence|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenY|Vaccines Group Differences at Day 86|29.0|||||2-Sided|97.5|18.4|40.0||||||Non-inferiority of seroresponse for two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenY|
1651373|NCT01682876|3039064|Non-Inferiority or Equivalence|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW|Vaccines Group Differences at Day 86|4.0|||||2-Sided|97.5|-8.6|17.4||||||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenW|
1651374|NCT01682876|3039064|Non-Inferiority or Equivalence|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC|Vaccines Group differences at Day 86|19.0|||||2-Sided|97.5|9.9|29.2||||||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenC|
1651375|NCT01682876|3039064|Non-Inferiority or Equivalence|Noninferiority was demonstrated for 6 to 10 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA|Vaccines Group Differences at Day 86|11.0|||||2-Sided|97.5|1.7|21.3||||||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenA|
1651376|NCT01682876|3039064|Non-Inferiority or Equivalence|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for Men Y|Vaccine Group differences at Day 86|27.0|||||2-Sided|97.5|15.6|37.6||||||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenY|
1651377|NCT01682876|3039064|Non-Inferiority or Equivalence|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenW|Vaccine Group Differences at Day 86|14.0|||||2-Sided|97.5|1.4|26.7||||||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenW|
1651378|NCT01682876|3039064|Non-Inferiority or Equivalence|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenC|Vaccine Group Differences at Day 86|27.0|||||2-Sided|97.5|16.9|37.7||||||Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenC|
1651379|NCT01682876|3039064|Non-Inferiority or Equivalence|Noninferiority was demonstrated for 2 to 5 years of age group if the lower limit of the 2-sided 97.5% confidence interval (CI) for the difference in seroresponse rate between the 2-dose vaccination schedule and the 1-dose vaccination schedule (2-dose schedule minus the 1-dose schedule) was greater than -10% for MenA|Vaccine Group Differences at Day 86|19.0|||||2-Sided|97.5|10.0|28.9||||||Non-inferiority of seroresponse of two vaccinations vs.one vaccination for age cohort (2 to 5 years of age) for MenA|
1651380|NCT01682837|3039073|Superiority or Other|||||||0.12|||||||Mixed Models Analysis||||
1651381|NCT01682837|3039074|Superiority or Other|||||||0.18|||||||Mixed Models Analysis||||
1651382|NCT01682837|3039075|Superiority or Other|||||||0.64|||||||Mixed Models Analysis||||
1651383|NCT01682837|3039076|Superiority or Other|||||||0.1|||||||Mixed Models Analysis||||
1651384|NCT01682837|3039077|Superiority or Other|||||||0.42|||||||Mixed Models Analysis||||
1651385|NCT01682837|3039078|Superiority or Other|||||||0.7|||||||Mixed Models Analysis||||
1651386|NCT01682837|3039079|Superiority or Other|||||||0.16|||||||Mixed Models Analysis||||
1651387|NCT01682837|3039080|Superiority or Other|||||||0.2|||||||Mixed Models Analysis||||
1651388|NCT01682837|3039081|Superiority or Other|||||||0.07|||||||Mixed Models Analysis||||
1651389|NCT01682759|3039082|Superiority or Other||Between-group Rate Difference|-10.3|||||2-Sided|95.0|-17.8|-2.8|||||Between-group CIs are calculated via Miettinen & Nurminen method.|A1C < 7.0%|
1651390|NCT01682759|3039083|Superiority or Other||Difference in the least squares means|-1.9|||<|0.001|2-Sided|95.0|-2.5|-1.4|||Difference in the least squares means||cLDA model including terms for treatment, time, and the interaction of time by treatment with the constraint that the mean baseline is the same for all treatment groups.||
1651391|NCT01682759|3039084|Superiority or Other||Difference in percentages|-21.3|||<|0.001|2-Sided|95.0|-26.5|-16.4|||Difference in percentages||Miettinen & Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.||
1651392|NCT01682759|3039085|Superiority or Other||Between-group Rate Difference (%)|-3.7|||||2-Sided|95.0|-10.6|3.3|||||Between-group CIs are calculated via Miettinen & Nurminen method.|A1C <6.5%|
1651393|NCT01682759|3039086|Superiority or Other||Difference in the least squares means|5.6|||||2-Sided|95.0|0.1|11.2|||||cLDA model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups||
1651482|NCT01681472|3039247|Other||Correlation factor|0.14436||||0.785|2-Sided||||||Pearson Correlation|||Correlation for ABCC1 gene expression|
1651394|NCT01682759|3039087|Superiority or Other||Difference in percentages|1.1|||||2-Sided|95.0|-1.6|3.8|||||Miettinen & Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.||
1651395|NCT01682759|3039088|Superiority or Other||Difference in percentages|-6.9|||||2-Sided|95.0|-13.9|0.1|||||Miettinen & Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.||
1651396|NCT01682759|3039089|Non-Inferiority or Equivalence|Omarigliptin was considered non-inferior to glimepiride if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference in least-squares (LS) means for change from baseline in A1C at Week 54 (omarigliptin vs. glimepiride) was lower than 0.35%.|Difference in the least squares means|0.18|||||2-Sided|95.0|0.06|0.3|||||Constrained longitudinal data analysis (cLDA) model including terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.||
1651397|NCT01682538|3039121|Non-Inferiority or Equivalence|Equivalence (no food effect) was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80 - 1.25)|Ratio of geometric means|0.802|||||2-Sided|90.0|0.71|0.9|||||||
1651398|NCT01682538|3039122|Non-Inferiority or Equivalence|Equivalence (no food effect) was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80 - 1.25).|Ratio of geometric means|1.013|||||2-Sided|90.0|0.96|1.07|||||||
1651399|NCT01682538|3039123|Non-Inferiority or Equivalence|Bioequivalence was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80-1.25)|Ratio of geometric means|0.954|||||2-Sided|90.0|0.85|1.07|||||||
1651400|NCT01682538|3039124|Non-Inferiority or Equivalence|Bioequivalence was established if the 90% confidence interval of the ratio was completely within the acceptance range (0.80-1.25)|Ratio of geometric means|0.858|||||2-Sided|90.0|0.81|0.91|||||||
1651401|NCT01682512|3039125|Superiority or Other||Adjusted ratio of gMeans (%)|87.47|Standard Error of the Mean|107.896|||2-Sided|90.0|77.12|99.21|||||Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups Rituxan and MabThera.|
1651402|NCT01682512|3039125|Superiority or Other||Adjusted ratio of gMeans (%)|91.39|Standard Error of the Mean|107.253|||2-Sided|90.0|81.38|102.64|||||Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and MabThera.|
1651403|NCT01682512|3039125|Superiority or Other||Adjusted ratio of gMeans (%)|104.49|Standard Error of the Mean|108.044|||2-Sided|90.0|91.92|118.78|||||Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and Rituxan.|
1651404|NCT01682512|3039127|Superiority or Other||Adjusted ratio of gMeans (%)|95.02|Standard Error of the Mean|105.744|||2-Sided|90.0|86.62|104.25|||||Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups Rituxan and MabThera.|
1651405|NCT01682512|3039127|Superiority or Other||Adjusted ratio of gMeans (%)|89.3|Standard Error of the Mean|105.657|||2-Sided|90.0|81.51|97.83|||||Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups BI 695500 and MabThera.|
1651406|NCT01682512|3039127|Superiority or Other||Adjusted ratio of gMeans (%)|93.97|Standard Error of the Mean|105.995|||2-Sided|90.0|85.32|103.5|||||Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of observed Cmax was compared between treatment groups BI 695500 and Rituxan.|
1651407|NCT01682512|3039128|Superiority or Other||Adjusted ratio of gMeans (%)|93.31|Standard Error of the Mean|105.7|||2-Sided|90.0|85.11|102.29|||||Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups Rituxan and MabThera.|
1651408|NCT01682512|3039128|Superiority or Other||Adjusted ratio of gMeans (%)|89.46|Standard Error of the Mean|106.775|||2-Sided|90.0|80.23|99.74|||||Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups BI 695500 and MabThera.|
1651409|NCT01682512|3039128|Superiority or Other||Adjusted ratio of gMeans (%)|95.87|Standard Error of the Mean|106.608|||2-Sided|90.0|86.21|106.62|||||Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(0-336) was compared between treatment groups BI 695500 and Rituxan.|
1651410|NCT01682512|3039129|Superiority or Other||Adjusted ratio of gMeans (%)|83.93|Standard Error of the Mean|107.386|||2-Sided|90.0|74.57|94.47|||||Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups Rituxan and MabThera.|
1651411|NCT01682512|3039129|Superiority or Other||Adjusted ratio of gMeans (%)|86.0|Standard Error of the Mean|107.404|||2-Sided|90.0|76.38|96.82|||||Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and MabThera.|
1651412|NCT01682512|3039129|Superiority or Other||Adjusted ratio of gMeans (%)|102.46|Standard Error of the Mean|107.939|||2-Sided|90.0|90.26|116.3|||||Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and Rituxan.|
1651413|NCT01682512|3039130|Superiority or Other||Adjusted ratio of gMeans (%)|86.18|Standard Error of the Mean|107.449|||2-Sided|90.0|76.5|97.09|||||Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups Rituxan and MabThera.|
1651414|NCT01682512|3039130|Superiority or Other||Adjusted ratio of gMeans (%)|88.21|Standard Error of the Mean|107.5|||2-Sided|90.0|78.24|99.46|||||Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and MabThera.|
1651415|NCT01682512|3039130|Superiority or Other||Adjusted ratio of gMeans (%)|102.35|Standard Error of the Mean|107.7|||2-Sided|90.0|90.5|115.76|||||Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error|The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and Rituxan.|
1651416|NCT01682512|3039131|Non-Inferiority or Equivalence|Equivalence for the change in DAS28 (ESR) was evaluated based on the two-sided 90% Confidence Interval (CI) for the treatment difference with respect to the mean change in the DAS28(ESR) score compared to baseline. Null hypothesis of non-equivalence was to be rejected if the 90% CI is fully contained within the interval of [-0.5, 0.5].|Adjusted mean difference|-0.4|||||2-Sided|90.0|-0.83|-0.03|||||Adjusted mean difference was calculated as: BI 695500 – Rituxan®||
1651417|NCT01682148|3039148|Superiority or Other|||||||0.1802|||||||Mann-Whitney U-test||||
1651418|NCT01682148|3039149|Superiority or Other|||||||0.5747|||||||Mann-Whitney U-test||||
1651419|NCT01682148|3039150|Superiority or Other|||||||0.4006|||||||ANOVA|ANOVA included factors for treatment, spasticity pattern and country.|||
1651420|NCT01682148|3039151|Superiority or Other|||||||0.5458|||||||ANOVA|ANOVA included factors for treatment, spasticity pattern and country, and Baseline VAS as a covariate.||Mean change in VAS from Baseline to Week 12.|
1651421|NCT01682148|3039151|Superiority or Other|||||||0.9448|||||||ANOVA|Analysis of variance (ANOVA) included factors for treatment, spasticity pattern and country, and Baseline VAS as a covariate.||Mean change in VAS from Baseline to Week 4.|
1651422|NCT01682148|3039152|Superiority or Other||Treatment difference|-0.1324||||0.24|2-Sided|95.0|-0.3531|0.0884||Based on a generalised linear model including factors for treatment, spasticity pattern, country and MAS baseline score.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.|
1651423|NCT01682148|3039154|Non-Inferiority or Equivalence|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.1758|2-Sided|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for MAS at Baseline.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.|
1651424|NCT01682148|3039154|Non-Inferiority or Equivalence|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.7732|2-Sided|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for country.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.|
1651425|NCT01682148|3039154|Non-Inferiority or Equivalence|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.5369|2-Sided|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for spasticity pattern.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.|
1651426|NCT01682148|3039154|Non-Inferiority or Equivalence|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|0.0707||||0.6052|2-Sided|95.0|-0.1948|0.3362||Based on a generalised linear model including factors for treatment.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.|
1651427|NCT01682148|3039154|Non-Inferiority or Equivalence|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.9167|2-Sided|95.0|-0.363|0.0284||Based on a generalised linear model including factors for MAS at Baseline.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.|
1651428|NCT01682148|3039154|Non-Inferiority or Equivalence|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.8543|2-Sided|5.0|-0.363|0.0284||Based on a generalised linear model including factors for country.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.|
1651429|NCT01682148|3039154|Non-Inferiority or Equivalence|Based on a π of 63% in the reference group, a clinically relevant Δ of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.5682|2-Sided|95.0|-0.363|0.0284||Based on a generalised linear model including factors for spasticity pattern.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.|
1651430|NCT01682148|3039154|Non-Inferiority or Equivalence|Based on a responder rate (π) of 63% in the reference group, a clinically relevant delta (Δ) of 17%, α=2.5% (one sided) and power=80%, the sample size estimate yielded 122 valid subjects per group. Including a 10% addition for premature withdrawals, 136 subjects per group were necessary to be randomised in the study (i.e., a total of 272 subjects).|Treatment difference|-0.1673||||0.0986|2-Sided|95.0|-0.363|0.0284||Based on a generalised linear model including factors for treatment.|Generalised linear model||Difference of the two clinical success rates (NMJ Targeted minus Current Clinical Practice).|A responder was defined as a subject with at least one level decrease on the MAS scale.|
1651431|NCT01682083|3039164|Superiority|A hazard ratio <1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio (HR)|0.47|||||2-Sided|95.0|0.39|0.57||||||Hazard ratio is estimated using Pike estimator.|
1651432|NCT01682083|3039165|Superiority|A hazard ratio <1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio, log|0.51|||||2-Sided|95.0|0.4|0.65||||||Hazard ratio is estimated using Pike estimator.|
1651433|NCT01682083|3039166|Superiority|A hazard ratio <1 indicates a lower risk with dabrafenib + trametinib compared with Placebo.|Hazard Ratio, log|0.57||||0.006|2-Sided|95.0|0.42|0.79|||Log Rank|the two-sided threshold for significance at this first interim analysis was p=0.000019||Hazard ratio is obtained from the stratified Pike estimator.|
1651434|NCT01682083|3039167|Superiority|Hazard ratio is obtained from the stratified Pike estimator. A hazard ratio <1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.|Hazard Ratio, log|0.47|||<|0.0001|2-Sided|95.0|0.39|0.58|||Log Rank|||The null hypothesis, H0: λ = 1 or reject it in favor of the alternative hypothesis, HA: λ ≠ 1, where λ is the hazard ratio (HR) of combination therapy relative to placebo.|
1651435|NCT01681992|3039202|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Med over pooled Com_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.|Adjusted GMC ratio|0.88|||||2-Sided|97.5|0.83|0.95||||||Non-inferiority of Inv_MMR_Med vaccine compared to COM_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.|
1651436|NCT01681992|3039202|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Min over pooled Com_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.|Adjusted GMC ratio|0.89|||||2-Sided|97.5|0.83|0.95||||||Non-inferiority of Inv_MMR_Min vaccine compared to COM_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.|
1651437|NCT01681992|3039203|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Med over pooled Com_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.|Adjusted GMT ratio|0.65|||||2-Sided|97.5|0.57|0.74||||||Non-inferiority of Inv_MMR_Med vaccine compared to COM_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.|
1651438|NCT01681992|3039203|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Min over pooled Com_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.|Adjusted GMT ratio|0.6|||||2-Sided|97.5|0.53|0.68||||||Non-inferiority of Inv_MMR_Min vaccine compared to COM_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.|
1651439|NCT01681992|3039204|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Med over pooled Com_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.|Adjusted GMC ratio|0.84|||||2-Sided|97.5|0.78|0.91||||||Non-inferiority of Inv_MMR_Med vaccine compared to COM_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.|
1651440|NCT01681992|3039204|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Min over pooled Com_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.|Adjusted GMC ratio|0.82|||||2-Sided|97.5|0.76|0.89||||||Non-inferiority of Inv_MMR_Min vaccine compared to COM_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.|
1651441|NCT01681992|3039205|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Med over pooled Com_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.|Adjusted GMC ratio|0.91|||||2-Sided|97.5|0.83|1.01||||||Non-inferiority of Inv_MMR_Med vaccine compared to COM_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.|
1651442|NCT01681992|3039205|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Min over pooled Com_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.|Adjusted GMC ratio|0.79|||||2-Sided|97.5|0.72|0.88||||||Non-inferiority of Inv_MMR_Min vaccine compared to COM_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.|
1651443|NCT01681992|3039206|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Med minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.|Difference in seroresponse rate|-1.18|||||2-Sided|97.5|-2.5|0.05|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv_MMR_Med vaccine compared to Com_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.|
1651444|NCT01681992|3039206|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Min minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.|Difference in seroresponse rate|-1.71|||||2-Sided|97.5|-3.11|-0.42|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv_MMR_Min vaccine compared to Com_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.|
1651445|NCT01681992|3039207|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Med minus Com_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.|Difference in seroresponse rate|-7.22|||||2-Sided|97.5|-10.94|-3.49|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv_MMR_Med vaccine compared to Com_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.|
1651446|NCT01681992|3039207|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Min minus Com_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.|Difference in seroresponse rate|-9.41|||||2-Sided|97.5|-13.2|-5.62|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv_MMR_Min vaccine compared to Com_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.|
1651447|NCT01681992|3039208|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Med minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.|Difference in seroresponse rate|-0.58|||||2-Sided|97.5|-2.11|0.91|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv_MMR_Med vaccine compared to Com_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.|
1651448|NCT01681992|3039208|Non-Inferiority|The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Min minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.|Difference in seroresponse rate|-0.42|||||2-Sided|97.5|-1.91|1.04|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv_MMR_Min vaccine compared to Com_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.|
1651449|NCT01681992|3039209|Non-Inferiority|The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv_MMR_Med minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.|Difference in seroresponse rate|-2.08|||||2-Sided|97.5|-3.96|-0.27|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv_MMR_Med vaccine compared to Com_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.|
1651450|NCT01681992|3039209|Non-Inferiority|The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv_MMR_Min minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.|Difference in seroresponse rate|-5.48|||||2-Sided|97.5|-7.65|-3.43|||||Asymptotic standardized 97.5% CI for the difference in seroresponse rate.|Non-inferiority of Inv_MMR_Min vaccine compared to Com_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.|
1651451|NCT01681810|3039222|Other|One-way repeated measures ANOVA comparing methemoglobin percent over time on nitrite drug to baseline (pre-drug) methemoglobin percent.||||||0.0127||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA||||
1651452|NCT01681810|3039223|Other|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.|||||<|0.0001||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA||||
1651453|NCT01681810|3039224|Other|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.|||||<|0.0001||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA||||
1651454|NCT01681810|3039225|Other|One-way repeated measures ANOVA comparing blood pressure over time on nitrite drug to baseline (pre-drug) blood pressure.||||||0.0074||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA||||
1651455|NCT01681810|3039226|Other|Paired t-test comparing insulin stimulated glucose disposal at end of 12 weeks on nitrite drug to baseline (pre-drug) insulin stimulated glucose disposal.||||||0.2068|||||||t-test, 2 sided||||
1651456|NCT01681771|3039227|Superiority|||||||0.21|||||||ANCOVA|ANCOVA analysis comparing PHQ-9 mean values at 9 weeks follow-up between the I-CBT and discussion group and adjusting for PHQ-9 values baseline|||
1651457|NCT01681628|3039229|Superiority or Other||Mean Difference (Final Values)|17.8|||<|0.001|2-Sided|95.0|15.2|20.5|||t-test, 2 sided|||Both the original treatment and control groups were combined as both groups had been treated at a similar time before the nineteen month assessment. The null hypothesis was that there had been no change in the PCL-C scores at nineteen months compared to one week following treatment.|
1651458|NCT01681628|3039230|Superiority or Other||Percentage|39.9|||<|0.001|2-Sided||||||Chi-squared||||
1651459|NCT01681628|3039230|Superiority or Other||% of participants with PCL score > 50|41.0|||<|0.001|2-Sided||||||Chi-squared|||Comparison of the percentage with diagnostic scores in the wait list group after no treatment at times 1 and 2.|
1651460|NCT01681628|3039230|Superiority or Other||percentage of participants|65.7|||<|0.001|2-Sided||||||Chi-squared|||Chi-squared test of any change in PCL-C from time 1 to time 2.|
1651461|NCT01681628|3039231|Superiority or Other||Mean Difference (Final Values)|20.6|Standard Deviation|13.5|<|0.001|2-Sided|95.0|17.1|22.5|||t-test, 2 sided|Degrees of freedom 94||Change in control group PCL-C scores after treatment, that is from time 2 to time 3.|
1651462|NCT01681628|3039231|Superiority or Other||Mean Difference (Final Values)|12.4|Standard Deviation|14.2|<|0.001|2-Sided|95.0|11.4|17.1|||t-test, 2 sided|||Changes in PCL-C scores for control group after no treatment.|
1651463|NCT01681628|3039231|Superiority or Other||Mean Difference (Final Values)|32.4|Standard Deviation|14.7|<|0.001|2-Sided|95.0|29.1|34.7|||t-test, 2 sided|||Change in PCL-C scores from before to after treatment.|
1651464|NCT01681628|3039231|Superiority or Other||Mean Difference (Final Values)|20.9|Standard Error of the Mean|2.0|<|0.001|2-Sided|95.0|16.1|24.0||This was an a priori threshold.|t-test, 2 sided|||Means and differences were calculated for both groups before (time 1) and after treatment (or no treatment) (time 2). Also, the differences in mean scores from time 1 to 2 were compared between the two groups, the primary outcome. The numbers in the groups were considered adequate based on previous similar studies. The null hypothesis was that there would be no difference in any mean change in scores from time 1 to 2, between both groups.|
1651465|NCT01681472|3039247|Other||Correlation factor|0.64565||||0.0838|2-Sided||||||Pearson Correlation|||Correlation for RFC-1 gene expression|
1651466|NCT01681472|3039247|Other||Correlation factor|-0.0245||||0.9632|2-Sided||||||Pearson Correlation|||Correlation for RFC-1 gene expression|
1651467|NCT01681472|3039247|Other||Correlation factor|0.23312||||0.5785|2-Sided||||||Pearson Correlation|||Correlation for RFC-1 gene expression|
1651468|NCT01681472|3039247|Other||Correlation factor|0.318||||0.487|2-Sided||||||Pearson Correlation|||Correlation for RFC-1 gene expression|
1651469|NCT01681472|3039247|Other||Correlation factor|0.55508||||0.1533|2-Sided||||||Pearson Correlation|||Correlation for SHMT2 gene expression|
1651470|NCT01681472|3039247|Other||Correlation factor|-0.71666||||0.109|2-Sided||||||Pearson Correlation|||Correlation for SHMT2 gene expression|
1651471|NCT01681472|3039247|Other||Correlation factor|0.86266||||0.0058|2-Sided||||||Pearson Correlation|||Correlation for SHMT2 gene expression|
1651472|NCT01681472|3039247|Other||Correlation factor|0.8104||||0.0271|2-Sided||||||Pearson Correlation|||Correlation for SHMT2 gene expression|
1651473|NCT01681472|3039247|Other||Correlation factor|0.59183||||0.1222|2-Sided||||||Pearson Correlation|||Correlation for SHMT1 gene expression|
1651474|NCT01681472|3039247|Other||Correlation factor|0.05531||||0.9171|2-Sided||||||Pearson Correlation|||Correlation for SHMT1 gene expression|
1651475|NCT01681472|3039247|Other||Correlation factor|0.67853||||0.0643|2-Sided||||||Pearson Correlation|||Correlation for SHMT1 gene expression|
1651476|NCT01681472|3039247|Other||Correlation factor|0.50966||||0.2426|2-Sided||||||Pearson Correlation|||Correlation for SHMT1 gene expression|
1651477|NCT01681472|3039247|Other||Correlation factor|0.74459||||0.0341|2-Sided||||||Pearson Correlation|||Correlation for MTHFD1L gene expression|
1651478|NCT01681472|3039247|Other||Correlation factor|0.20955||||0.6903|2-Sided||||||Pearson Correlation|||Correlation for MTHFD1L gene expression|
1651479|NCT01681472|3039247|Other||Correlation factor|0.3716||||0.3647|2-Sided||||||Pearson Correlation|||Correlation for MTHFD1L gene expression|
1651480|NCT01681472|3039247|Other||Correlation factor|0.32113||||0.4825|2-Sided||||||Pearson Correlation|||Correlation for MTHFD1L gene expression|
1651484|NCT01681472|3039247|Other||Correlation factor|0.82963||||0.0209|2-Sided||||||Pearson Correlation|||Correlation for ABCC1 gene expression|
1651485|NCT01681472|3039247|Other||Correlation factor|0.78928||||0.0199|2-Sided||||||Pearson Correlation|||Correlation for GGH gene expression|
1651486|NCT01681472|3039247|Other||Correlation factor|-0.09737||||0.8544|2-Sided||||||Pearson Correlation|||Correlation for GGH gene expression|
1651487|NCT01681472|3039247|Other||Correlation factor|0.46883||||0.2413|2-Sided||||||Pearson Correlation|||Correlation for GGH gene expression|
1651488|NCT01681472|3039247|Other||Correlation factor|0.93711||||0.0018|2-Sided||||||Pearson Correlation|||Correlation for GGH gene expression|
1651489|NCT01681472|3039247|Other||Correlation factor|0.00322||||0.994|2-Sided||||||Pearson Correlation|||Correlation for ABCC3 gene expression|
1651490|NCT01681472|3039247|Other||Correlation factor|0.777||||0.0691|2-Sided||||||Pearson Correlation|||Correlation for ABCC3 gene expression|
1651491|NCT01681472|3039247|Other||Correlation factor|-0.25891||||0.5358|2-Sided||||||Pearson Correlation|||Correlation for ABCC3 gene expression|
1651492|NCT01681472|3039247|Other||Correlation factor|-0.38987||||0.3873|2-Sided||||||Pearson Correlation|||Correlation for ABCC3 gene expression|
1651493|NCT01681472|3039247|Other||Correlation factor|0.9584||||0.0002|2-Sided||||||Pearson Correlation|||Correlation for MTHFS gene expression|
1651494|NCT01681472|3039247|Other||Correlation factor|0.58419||||0.2234|2-Sided||||||Pearson Correlation|||Correlation for MTHFS gene expression|
1651495|NCT01681472|3039247|Other||Correlation factor|0.43194||||0.2852|2-Sided||||||Pearson Correlation|||Correlation for MTHFS gene expression|
1651496|NCT01681472|3039247|Other||Correlation factor|0.94364||||0.0014|2-Sided||||||Pearson Correlation|||Correlation for MTHFS gene expression|
1651497|NCT01681472|3039247|Other||Correlation factor|0.17664||||0.6756|2-Sided||||||Pearson Correlation|||Correlation for FPGS gene expression|
1651498|NCT01681472|3039247|Other||Correlation factor|-0.64743||||0.1645|2-Sided||||||Pearson Correlation|||Correlation for FPGS gene expression|
1651499|NCT01681472|3039247|Other||Correlation factor|0.88682||||0.0033|2-Sided||||||Pearson Correlation|||Correlation for FPGS gene expression|
1651500|NCT01681472|3039247|Other||Correlation factor|0.97624||||0.0002|2-Sided||||||Pearson Correlation|||Correlation for FPGS gene expression|
1651501|NCT01681472|3039247|Other||Correlation factor|0.11497||||0.7863|2-Sided||||||Pearson Correlation|||Correlation for PCFT gene expression|
1651502|NCT01681472|3039247|Other||Correlation factor|0.89976||||0.0146|2-Sided||||||Pearson Correlation|||Correlation for PCFT gene expression|
1651503|NCT01681472|3039247|Other||Correlation factor|0.58502||||0.1277|2-Sided||||||Pearson Correlation|||Correlation for PCFT gene expression|
1651504|NCT01681472|3039247|Other||Correlation factor|0.88128||||0.0087|2-Sided||||||Pearson Correlation|||Correlation for PCFT gene expression|
1651505|NCT01681472|3039247|Other||Correlation factor|-0.47193||||0.2377|2-Sided||||||Pearson Correlation|||Correlation for AMT gene expression|
1651506|NCT01681472|3039247|Other||Correlation factor|-0.7073||||0.116|2-Sided||||||Pearson Correlation|||Correlation for AMT gene expression|
1651507|NCT01681472|3039247|Other||Correlation factor|0.75404||||0.0307|2-Sided||||||Pearson Correlation|||Correlation for AMT gene expression|
1651508|NCT01681472|3039247|Other||Correlation factor|0.42972||||0.3359|2-Sided||||||Pearson Correlation|||Correlation for AMT gene expression|
1651509|NCT01681472|3039248|Other|||||||0.0451|||||||pearson||||
1651510|NCT01681472|3039249|Other||Correlation factor|0.11512||||0.8281|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor|
1651511|NCT01681472|3039249|Other||Correlation factor|0.68778||||0.0594|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor|
1651512|NCT01681472|3039249|Other||Correlation factor|0.02576||||0.9672|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa|
1651513|NCT01681472|3039249|Other||Correlation factor|0.23512||||0.5751|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa|
1651514|NCT01681472|3039250|Other||Correlation factor|0.36854||||0.369|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa|
1651515|NCT01681472|3039250|Other||Correlation factor|-0.66295||||0.1513|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa|
1651516|NCT01681472|3039250|Other||Correlation factor|0.34496||||0.4027|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa|
1651517|NCT01681472|3039250|Other||Correlation factor|0.76502||||0.0451|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. conc in adjacent mucosa|
1651518|NCT01681472|3039250|Other||Correlation factor|0.09033||||0.8315|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor|
1651519|NCT01681472|3039250|Other||Correlation factor|0.03292||||0.9506|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor|
1651520|NCT01681472|3039250|Other||Correlation factor|0.44757||||0.2661|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor|
1651521|NCT01681472|3039250|Other||Correlation factor|0.73743||||0.0586|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. conc in tumor|
1651522|NCT01681472|3039251|Other||Correlation factor|0.07937||||0.8518|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa|
1651523|NCT01681472|3039251|Other||Correlation factor|0.34905||||0.3967|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa|
1651524|NCT01681472|3039251|Other||Correlation factor|0.45404||||0.3061|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa|
1651525|NCT01681472|3039251|Other||Correlation factor|-0.02188||||0.959|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor|
1651526|NCT01681472|3039251|Other||Correlation factor|0.27018||||0.5175|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor|
1651527|NCT01681472|3039251|Other||Correlation factor|0.38298||||0.3964|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor|
1651528|NCT01681472|3039252|Other||Correlation factor|0.68223||||0.0913|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa|
1651529|NCT01681472|3039252|Other||Correlation factor|0.27618||||0.5079|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in adjacent mucosa|
1651530|NCT01681472|3039252|Other||Correlation factor|0.54039||||0.2105|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor|
1653314|NCT01656850|3042323|Superiority or Other|||||||0.1205|||||||Mixed Models Analysis||||
1651531|NCT01681472|3039252|Other||Correlation factor|-0.21666||||0.6063|2-Sided||||||Pearson Correlation|||AUC(0-2h) vs. concentration in tumor|
1651532|NCT01681472|3039253|Superiority|||||||0.5286|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651533|NCT01681472|3039253|Superiority|||||||0.0017|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651534|NCT01681472|3039253|Superiority|||||||0.0125|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651535|NCT01681472|3039253|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651536|NCT01681472|3039253|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651537|NCT01681472|3039253|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651538|NCT01681472|3039254|Superiority|||||||0.0107|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651539|NCT01681472|3039254|Superiority|||||||0.0303|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651540|NCT01681472|3039254|Superiority|||||||0.599|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651541|NCT01681472|3039254|Superiority|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651542|NCT01681472|3039254|Superiority|||||||0.4945|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651543|NCT01681472|3039254|Superiority|||||||0.1791|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651544|NCT01681472|3039255|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651545|NCT01681472|3039255|Superiority|||||||0.1213|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651546|NCT01681472|3039255|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651547|NCT01681472|3039255|Superiority|||||||0.064|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651548|NCT01681472|3039255|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651549|NCT01681472|3039255|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651550|NCT01681472|3039256|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651551|NCT01681472|3039256|Superiority|||||||0.6691|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651552|NCT01681472|3039256|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651553|NCT01681472|3039256|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651743|NCT01680835|3039431|Other|No hypothesis testing was done at this endpoint|Kaplan Meier|0.86|Standard Error of the Mean|0.034|||2-Sided|||||||||Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 1 year|
1651554|NCT01681472|3039256|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651555|NCT01681472|3039256|Superiority|||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651556|NCT01681472|3039257|Superiority|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651557|NCT01681472|3039257|Superiority|||||||0.0502|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651558|NCT01681472|3039257|Superiority|||||||0.0668|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651559|NCT01681472|3039257|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651560|NCT01681472|3039257|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651561|NCT01681472|3039257|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651562|NCT01681472|3039258|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651563|NCT01681472|3039258|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651564|NCT01681472|3039258|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651565|NCT01681472|3039258|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651566|NCT01681472|3039258|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651567|NCT01681472|3039258|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651568|NCT01681472|3039259|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651569|NCT01681472|3039259|Superiority|||||||0.0043|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651570|NCT01681472|3039259|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651571|NCT01681472|3039259|Superiority|||||||0.0058|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651572|NCT01681472|3039259|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651573|NCT01681472|3039259|Superiority|||||||0.0177|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651574|NCT01681472|3039260|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651575|NCT01681472|3039260|Superiority|||||||0.0933|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651576|NCT01681472|3039260|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651744|NCT01680835|3039432|Other|No hypothesis testing was done for this endpoint|Kaplan Meier|0.965|Standard Error of the Mean|0.02|||2-Sided|||||||||Stent Fracture at 3 Years|
1651577|NCT01681472|3039260|Superiority|||||||0.0227|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651578|NCT01681472|3039260|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651579|NCT01681472|3039260|Superiority|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of t1/2 was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651580|NCT01681472|3039261|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651581|NCT01681472|3039261|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651582|NCT01681472|3039261|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651583|NCT01681472|3039261|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651584|NCT01681472|3039261|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651585|NCT01681472|3039261|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651586|NCT01681472|3039262|Superiority|||||||0.0061|||||||Wilcoxon (Mann-Whitney)||||
1651587|NCT01681472|3039262|Superiority|||||||0.2041|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651588|NCT01681472|3039262|Superiority|||||||0.0268|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651589|NCT01681472|3039262|Superiority|||||||0.0263|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651590|NCT01681472|3039262|Superiority|||||||0.3243|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651591|NCT01681472|3039262|Superiority|||||||0.1796|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651592|NCT01681472|3039263|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651593|NCT01681472|3039263|Superiority|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651594|NCT01681472|3039263|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651595|NCT01681472|3039263|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651596|NCT01681472|3039263|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651597|NCT01681472|3039263|Superiority|||||||0.0056|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651598|NCT01681472|3039264|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651599|NCT01681472|3039264|Superiority|||||||0.0005|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651600|NCT01681472|3039264|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651745|NCT01680835|3039432|Other|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.989|Standard Error of the Mean|0.01|||2-Sided|||||||||Stent Fracture at 2 Years|
1651601|NCT01681472|3039264|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651602|NCT01681472|3039264|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651603|NCT01681472|3039264|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of tmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651604|NCT01681472|3039265|Superiority|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651605|NCT01681472|3039265|Superiority|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651606|NCT01681472|3039265|Superiority|||||||0.0142|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651607|NCT01681472|3039265|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651608|NCT01681472|3039265|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651609|NCT01681472|3039265|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651610|NCT01681472|3039266|Superiority|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651611|NCT01681472|3039266|Superiority|||||||0.1563|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651612|NCT01681472|3039266|Superiority|||||||0.1551|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651613|NCT01681472|3039266|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651614|NCT01681472|3039266|Superiority|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651615|NCT01681472|3039266|Superiority|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651616|NCT01681472|3039267|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651617|NCT01681472|3039267|Superiority|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651618|NCT01681472|3039267|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651619|NCT01681472|3039267|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651620|NCT01681472|3039267|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651621|NCT01681472|3039267|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651622|NCT01681472|3039268|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651623|NCT01681472|3039268|Superiority|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651624|NCT01681472|3039268|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651625|NCT01681472|3039268|Superiority|||||||0.0021|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651626|NCT01681472|3039268|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651627|NCT01681472|3039268|Superiority|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of Cmax was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651628|NCT01681472|3039269|Superiority|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651629|NCT01681472|3039269|Superiority|||||||0.0085|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651630|NCT01681472|3039269|Superiority|||||||0.0142|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651631|NCT01681472|3039269|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651632|NCT01681472|3039269|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651633|NCT01681472|3039269|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651634|NCT01681472|3039270|Superiority|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651635|NCT01681472|3039270|Superiority|||||||0.1893|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651636|NCT01681472|3039270|Superiority|||||||0.2725|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651637|NCT01681472|3039270|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651638|NCT01681472|3039270|Superiority|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651639|NCT01681472|3039270|Superiority|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651640|NCT01681472|3039271|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651641|NCT01681472|3039271|Superiority|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651642|NCT01681472|3039271|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651643|NCT01681472|3039271|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651644|NCT01681472|3039271|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651645|NCT01681472|3039271|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651646|NCT01681472|3039272|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651647|NCT01681472|3039272|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1652399|NCT01672970|3040368|Superiority or Other|||||||0|||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3|
1651648|NCT01681472|3039272|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651649|NCT01681472|3039272|Superiority|||||||0.0022|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651650|NCT01681472|3039272|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651651|NCT01681472|3039272|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(last) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651652|NCT01681472|3039273|Superiority|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651653|NCT01681472|3039273|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651654|NCT01681472|3039273|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651655|NCT01681472|3039273|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651656|NCT01681472|3039273|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651657|NCT01681472|3039273|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651658|NCT01681472|3039274|Superiority|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651659|NCT01681472|3039274|Superiority|||||||0.9581|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651660|NCT01681472|3039274|Superiority|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651661|NCT01681472|3039274|Superiority|||||||0.0166|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651662|NCT01681472|3039274|Superiority|||||||0.2246|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651663|NCT01681472|3039274|Superiority|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651664|NCT01681472|3039275|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651665|NCT01681472|3039275|Superiority|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651666|NCT01681472|3039275|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651667|NCT01681472|3039275|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651668|NCT01681472|3039275|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651669|NCT01681472|3039275|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651670|NCT01681472|3039276|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1652400|NCT01672970|3040369|Superiority or Other|||||||0|||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6|
1651671|NCT01681472|3039276|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651672|NCT01681472|3039276|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651673|NCT01681472|3039276|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651674|NCT01681472|3039276|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651675|NCT01681472|3039276|Superiority|||||||0|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of AUC(0-2h) was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651676|NCT01681472|3039277|Superiority|||||||0.0338|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651677|NCT01681472|3039277|Superiority|||||||0.0014|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651678|NCT01681472|3039277|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651679|NCT01681472|3039277|Superiority||||||<|0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651680|NCT01681472|3039277|Superiority||||||<|0.0058|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651681|NCT01681472|3039277|Superiority||||||<|0.024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-formyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651682|NCT01681472|3039278|Superiority|||||||0.0055|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651683|NCT01681472|3039278|Superiority|||||||0.0009|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651684|NCT01681472|3039278|Superiority|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651685|NCT01681472|3039278|Superiority|||||||0.0015|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651686|NCT01681472|3039278|Superiority|||||||0.0034|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651687|NCT01681472|3039278|Superiority|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-formyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651688|NCT01681472|3039279|Superiority|||||||0.0055|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651689|NCT01681472|3039279|Superiority|||||||0.4309|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651690|NCT01681472|3039279|Superiority|||||||0.0003|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651691|NCT01681472|3039279|Superiority|||||||0.0428|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651692|NCT01681472|3039279|Superiority|||||||0.2246|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651693|NCT01681472|3039279|Superiority|||||||0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-methyl-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651694|NCT01681472|3039280|Superiority|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651695|NCT01681472|3039280|Superiority|||||||0.3184|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651696|NCT01681472|3039280|Superiority|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651697|NCT01681472|3039280|Superiority|||||||0.1182|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651698|NCT01681472|3039280|Superiority|||||||0.8303|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651699|NCT01681472|3039280|Superiority|||||||0.0092|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-methyl-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651700|NCT01681472|3039281|Superiority|||||||0.0454|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651701|NCT01681472|3039281|Superiority|||||||0.0039|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651702|NCT01681472|3039281|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651703|NCT01681472|3039281|Superiority||||||<|0.0728|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651704|NCT01681472|3039281|Superiority||||||<|0.0124|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651705|NCT01681472|3039281|Superiority||||||<|0.2716|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651706|NCT01681472|3039282|Superiority|||||||0.4777|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651707|NCT01681472|3039282|Superiority|||||||0.0313|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651708|NCT01681472|3039282|Superiority|||||||0.0081|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651709|NCT01681472|3039282|Superiority|||||||0.5244|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651710|NCT01681472|3039282|Superiority|||||||0.0538|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651711|NCT01681472|3039282|Superiority|||||||0.1182|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6S]-5-THF concentration in tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651712|NCT01681472|3039283|Superiority|||||||0.0118|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6R]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651713|NCT01681472|3039283|Superiority|||||||0.0019|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6R]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651714|NCT01681472|3039283|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6R]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651715|NCT01681472|3039283|Superiority||||||<|0.0177|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6R]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651716|NCT01681472|3039283|Superiority||||||<|0.0034|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6R]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651717|NCT01681472|3039283|Superiority||||||<|0.148|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6R]-5,10-methylene-THF concentration in mucosa adjacent to the tumor was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651718|NCT01681472|3039284|Superiority|||||||0.1752|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6R]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651719|NCT01681472|3039284|Superiority|||||||0.0074|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6R]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651720|NCT01681472|3039284|Superiority|||||||0.0024|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6R]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651721|NCT01681472|3039284|Superiority|||||||0.8622|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6R]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651722|NCT01681472|3039284|Superiority|||||||0.1336|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6R]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651723|NCT01681472|3039284|Superiority|||||||0.0323|||||||Wilcoxon (Mann-Whitney)|||The exploratory evaluation of [6R]-5,10-methylene-THF concentration in tumor tissue was done respectively for differences between treatments using Wilcoxon test. Differences in variability between the treatment groups were assessed using Proc GLM and Levene’s test.|
1651724|NCT01681277|3039304|Superiority or Other||Slope|1.3135|Standard Error of the Mean|0.1206|||2-Sided|95.0|1.0652|1.5618|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope"|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for AUCt,ss was analysed.|
1651725|NCT01681277|3039306|Superiority or Other||Slope|1.2208|Standard Error of the Mean|0.1386|||2-Sided|95.0|0.9354|1.5062|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope"|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 for Cmax,ss was analysed.|
1651726|NCT01681030|3039358|Superiority or Other||Proportion|0.455|||||2-Sided|95.0|0.167|0.766|||||CI for Standard of Care group||
1651727|NCT01681030|3039358|Superiority or Other||Proportion|0.333|||||2-Sided|95.0|0.133|0.59|||||CI for Topical Hemostat group||
1651728|NCT01681030|3039358|Superiority or Other||Proportion|0.923|||||2-Sided|95.0|0.64|0.998|||||CI for EVARREST Group||
1651729|NCT01680900|3039406|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.05|2-Sided|95.0|-0.74|-0.21|||Regression, Linear||||
1651730|NCT01680900|3039410|Superiority or Other||Mean Difference (Final Values)|-0.19|||<|0.05|2-Sided|95.0|-0.75|-0.08|||Regression, Linear||||
1651731|NCT01680900|3039411|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1651732|NCT01680900|3039412|Superiority or Other||Mean Difference (Final Values)|-1.06||||0.05|2-Sided|95.0|-2.6|-0.48|||Regression, Linear||||
1651733|NCT01680887|3039414|Superiority|||||||0.403|||||||Chi-squared||||
1651734|NCT01680861|3039416|Superiority or Other|||||||0.65|||||||t-test, 2 sided||||
1651735|NCT01680861|3039417|Superiority or Other|||||||0.18|||||||t-test, 2 sided||||
1651736|NCT01680861|3039418|Superiority or Other|||||||0.06|||||||t-test, 2 sided||||
1651737|NCT01680861|3039419|Superiority or Other|||||||1|||||||Log Rank||||
1651738|NCT01680861|3039420|Superiority or Other|||||||0.99|||||||Log Rank||||
1651739|NCT01680861|3039421|Superiority or Other|||||||0.32|||||||Log Rank||||
1651740|NCT01680835|3039429|Other||Kaplan Meier|0.781|Standard Error of the Mean|0.04|||2-Sided|||||||||Freedom from clinically-driven TLR through 3 Years|
1651741|NCT01680835|3039430|Other|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.99|Standard Error of the Mean|0.01|||2-Sided|||||||||Estimate from freedom from major amputation through 3 years.|
1651742|NCT01680835|3039431|Other|No hypothesis testing was done for this endpoint.|Kaplan Meier|0.782|Standard Error of the Mean|0.04|||2-Sided|||||||||Freedom from acute death, freedom from amputation and freedom from clinically-driven target lesion revascularization at 2 years|
1653315|NCT01656850|3042324|Superiority or Other|||||||0.0476|||||||Mixed Models Analysis||||
1651746|NCT01680835|3039432|Other|No hypothesis Testing for this endpoint.|Kaplan Meier|1.0|Standard Error of the Mean|0.0|||2-Sided|||||||||Stent Fracture at 1 Year|
1651747|NCT01680835|3039433|Other|Freedom from primary safety composite event at 36 months compared to a performance goal of 35%|Kaplan Meier|0.771|||<|0.001|1-Sided|97.5|0.678||||Log Rank||||
1651748|NCT01680653|3039449|Superiority or Other|||||||0.077|||||||Fisher's exact|||This is the P value for the number of events <50 mg/dL that were >1 hr|
1651749|NCT01680653|3039449|Superiority or Other|||||||0.021|||||||Fisher's exact test|||This is the p value for the number of events that were <50 mg/dL for > 30 minutes|
1651750|NCT01680653|3039449|Superiority or Other|||||||0.01|||||||Fisher's exact test|||This is the p value for the number of events <70 mg/dL that were greater than 2 hours|
1651751|NCT01680653|3039449|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||This is the P value for the number of events <70 mg/dL longer than one hour|
1651752|NCT01680653|3039450|Superiority or Other|||||||0.078|||||||Wilcoxon (Mann-Whitney)||||
1651753|NCT01680653|3039451|Superiority or Other|||||||0.106||||||In analyzing prolonged events on remote monitoring versus control, we used x squared analysis or Fisher's exact test to analyze data on 2 x 2 contingency tables. Significance was defined as P<0.05.|Wilcoxon (Mann-Whitney)|||The study was a feasibility and preliminary safety study. As such, the sample size was not statistically derived and the protocol was not powered to provide for definitive conclusions. The study was limited to 20 participants at each camp session. A hypoglycemic event was defined as at least two consecutive CGM readings (10 mins) below the hypoglycemic threshold of <70 mg/dL. Recovery from a hypoglycemic event required readings above threshold for > or = 25 minutes.|
1651754|NCT01680328|3039477|Superiority or Other||Least Square Mean Difference|1.7||||||95.0|0.5|2.9||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.|
1651755|NCT01680328|3039477|Superiority or Other||Least Square Mean Difference|4.9||||||95.0|3.7|6.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.|
1651756|NCT01680328|3039477|Superiority or Other||Least Square Mean Difference|1.6||||||95.0|0.3|2.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.|
1651757|NCT01680328|3039477|Superiority or Other||Least Square Mean Difference|0.8||||||95.0|-0.4|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.|
1651758|NCT01680328|3039477|Superiority or Other||Least Square Mean Difference|0.3||||||95.0|-0.9|1.5||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the thigh at different volume and speed combinations.|
1651759|NCT01680328|3039478|Superiority or Other||Least Square Mean Difference|0.6||||||95.0|-0.6|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.|
1651760|NCT01680328|3039478|Superiority or Other||Least Square Mean Difference|1.4||||||95.0|0.2|2.6||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.|
1651761|NCT01680328|3039478|Superiority or Other||Least Square Mean Difference|2.3||||||95.0|1.0|3.5||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.|
1651762|NCT01680328|3039478|Superiority or Other||Least Square Mean Difference|1.1||||||95.0|-0.1|2.3||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.|
1651763|NCT01680328|3039478|Superiority or Other||Least Square Mean Difference|0.8||||||95.0|-0.4|2.0||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.|
1651764|NCT01680328|3039478|Superiority or Other||Least Square Mean Difference|0.9||||||95.0|-0.3|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.|
1651765|NCT01680328|3039478|Superiority or Other||Least Square Mean Difference|0.5||||||95.0|-0.7|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.|
1651766|NCT01680328|3039478|Superiority or Other||Least Square Mean Difference|0.5||||||95.0|-0.8|1.7||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.|
1651767|NCT01680328|3039478|Superiority or Other||Least Square Mean Difference|0.5||||||95.0|-0.8|1.7||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.|
1651768|NCT01680328|3039478|Superiority or Other||Least Square Mean Difference|0.9||||||95.0|-0.4|2.1||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.|
1651769|NCT01680328|3039478|Superiority or Other||Least Square Mean Difference|0.4||||||95.0|-0.8|1.6||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.|
1651770|NCT01680328|3039478|Superiority or Other||Least Square Mean Difference|0.6||||||95.0|-0.6|1.8||||||Backflow (absorbed amount of liquid 2 minutes (±30 sec) after the injection with filter-paper rated according to the liquid scale) was analysed using a mixed ANOVA approach and calculated as the mean differences in backflow in the abdomen at different volume and speed combinations.|
1651771|NCT01680328|3039479|Superiority or Other||Odds Ratio (OR)|3.7||||||95.0|2.4|5.5||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as ‘no versus yes’, so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain in the thighs – i.e. a worse condition.|
1651772|NCT01680328|3039480|Superiority or Other||Odds Ratio (OR)|0.9||||||95.0|0.6|1.2||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as ‘no versus yes’, and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed – i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.|
1651773|NCT01680328|3039480|Superiority or Other||Odds Ratio (OR)|1.1||||||95.0|0.7|1.8||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as ‘no versus yes’, and 'higher speed versus lower', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the higher speed – i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.|
1651774|NCT01680328|3039481|Superiority or Other||Odds Ratio (OR)|1.0||||||95.0|0.7|1.5||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as ‘no versus yes’, and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume – i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.|
1651775|NCT01680328|3039481|Superiority or Other||Odds Ratio (OR)|2.6||||||95.0|1.4|4.6||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as ‘no versus yes’, and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume – i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.|
1651776|NCT01680328|3039481|Superiority or Other||Odds Ratio (OR)|2.6||||||95.0|1.4|4.8||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as ‘no versus yes’, and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume – i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.|
1651777|NCT01680328|3039481|Superiority or Other||Odds Ratio (OR)|2.1||||||95.0|1.4|3.0||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as ‘no versus yes’, and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume – i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.|
1651778|NCT01680328|3039481|Superiority or Other||Odds Ratio (OR)|2.1||||||95.0|1.2|3.5||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as ‘no versus yes’, and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume – i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.|
1651779|NCT01680328|3039481|Superiority or Other||Odds Ratio (OR)|0.8||||||95.0|0.5|1.4||||||Acceptance of pain was rated subjectively as yes or no by the subject after each injection. The odds are calculated as ‘no versus yes’, and 'larger volume versus smaller', so that an odds ratio above 1 corresponds to a higher frequency of unacceptable pain for the larger volume – i.e. a worse condition. The odd ratios for unacceptable injection pain are based on a statistical model for all acceptance pain data.|
1651780|NCT01680328|3039482|Superiority or Other||Least Squares Mean|9.0||||||95.0|6.7|11.3||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. The mean difference in injection pain on a VAS (mm) between the thighs and abdomen was calculated as the least square mean estimate of the mean difference in injection pain on a VAS (mm) between the thighs and abdomen.|
1651781|NCT01680328|3039482|Superiority or Other||Least Squares Mean|-0.4||||||95.0|-2.7|1.9||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.|
1651782|NCT01680328|3039482|Superiority or Other||Least Squares Mean|0.4||||||95.0|-2.1|2.9||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean difference in injection pain on VAS after injection at different speeds was calculated as least square mean estimate of the mean difference in injection pain on a VAS after injection at different speeds.|
1651802|NCT01678820|3039624|Superiority or Other||Difference in estimated means|-10.3||||0.365|2-Sided|95.0|-33.6|13.0|||Robust regression|Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.|||
1651783|NCT01680328|3039482|Superiority or Other||Least Squares Mean|3.7||||||95.0|0.6|6.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.|
1651784|NCT01680328|3039482|Superiority or Other||Least Squares Mean|7.2||||||95.0|4.4|10.0||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.|
1651785|NCT01680328|3039482|Superiority or Other||Least Squares Mean|3.6||||||95.0|0.4|6.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.|
1651786|NCT01680328|3039482|Superiority or Other||Least Squares Mean|7.2||||||95.0|4.6|9.7||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.|
1651787|NCT01680328|3039482|Superiority or Other||Least Squares Mean|3.5||||||95.0|0.4|6.6||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.|
1651788|NCT01680328|3039482|Superiority or Other||Least Squares Mean|-0.1||||||95.0|-2.9|2.8||||||Though the sample size was not based on any formal sample size or power calculations as no statistical tests were pre-specified to address the endpoints, a sample size of 80 completers was derived from a simulation study. Mean Difference in injection pain on VAS after injection of different volumes was calculated as least square mean estimate of the mean difference in injection pain.|
1651789|NCT01680016|3039500|Non-Inferiority or Equivalence|Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5|Ratio of GMCs between two groups(Day 15)|1.09|||||2-Sided|95.0|0.87|1.35||||||To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in older adults aged ≥51 years|
1651790|NCT01680016|3039501|Non-Inferiority or Equivalence|Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5|Ratio of GMCs between two groups(Day 15)|0.84|||||2-Sided|95.0|0.69|1.02||||||To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in children aged ≥6 to ≤17 years|
1651791|NCT01679613|3039502|Superiority or Other||Geometric Mean Ratio in percentage|168.09|Standard Deviation|17.9||1|2-Sided|90.0|155.252|181.981||p-value for ratio outside interval 0.8 to 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"The standard deviation is actually the gCV.~Ratio calculated as nintedanib+ketoconazole divided by nintedanib (in %)."||
1651792|NCT01679613|3039503|Superiority or Other||Geometric Mean Ratio in percentage|179.62|Standard Deviation|29.9||1|2-Sided|90.0|157.557|204.779||p-value for ratio outside interval 0.8 - 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"The standard deviation is actually the gCV (in %).~Ratio calculated as nintedanib+ketoconazole divided by nintedanib"||
1651793|NCT01679613|3039504|Superiority or Other||Geometric Mean Ratio in percentage|160.48|Standard Deviation|17.9||1|2-Sided|90.0|148.245|173.736||p-value for ratio outside interval 0.8 - 1.25|ANOVA|The model includes fixed effects for sequence, period, and treatment. Subjects within sequences is included as random effect.|"Ratio calculated as nintedanib+ketoconazole divided by nintedanib (in %).~The standard deviation is actually the geometric coefficient of variation (gCV)."||
1651794|NCT01679600|3039505|Superiority or Other|||||||0.53|||||||F1-LD-F1 model by Brunner and Langer||||
1651795|NCT01678846|3039620|Superiority or Other||Odds Ratio (OR)|0.4|||<|0.0001|2-Sided|95.0|0.26|0.64|||Regression, Logistic||An odds ratio of less than 1 would demonstrate a protective effect of the intervention. Unadjusted odds ratio presented, accounting for correlation between students within schools.|Does the Toolkit intervention reduce physical violence from school staff to Ugandan primary school students.|
1651796|NCT01678820|3039621|Superiority or Other||Difference in percents|12.3|||||2-Sided|95.0|0.7|24.0|||||Based on Miettinen & Nurminen method. Missing data were imputed by multiple imputations.||
1651797|NCT01678820|3039621|Superiority or Other||Difference in percents|0.3|||||2-Sided|95.0|-12.2|12.9|||||Based on Miettinen & Nurminen method. Missing data were imputed by multiple impuattions.||
1651798|NCT01678820|3039622|Superiority or Other||Difference in least squares means|-15.3||||0.141|2-Sided|95.0|-35.8|5.1|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651799|NCT01678820|3039622|Superiority or Other||Difference in least squares means|-30.4||||0.004|2-Sided|95.0|-51.0|-9.7|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651800|NCT01678820|3039623|Superiority or Other||Difference in least squares means|0.4||||0.879|2-Sided|95.0|-4.8|5.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651801|NCT01678820|3039623|Superiority or Other||Difference in least squares means|0.5||||0.857|2-Sided|95.0|-4.8|5.8|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651803|NCT01678820|3039624|Superiority or Other||Difference in estimated means|-15.5||||0.068|2-Sided|95.0|-32.2|1.2|||Robust regression|Using M-estimation with treatment, region, and a covariate for baseline triglycerides (mg/dL). Missing data were imputed by multiple imputations.|||
1651804|NCT01678820|3039625|Superiority or Other||Difference in least squares means|0.3||||0.937|2-Sided|95.0|-7.7|8.3|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651805|NCT01678820|3039625|Superiority or Other||Difference in least squares means|-24.4|||<|0.001|2-Sided|95.0|-32.6|-16.3|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651806|NCT01678820|3039626|Superiority or Other||Difference in least squares means|2.9||||0.469|2-Sided|95.0|-5.0|10.7|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651807|NCT01678820|3039626|Superiority or Other||Difference in least squares means|-20.2|||<|0.001|2-Sided|95.0|-28.3|-12.2|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651808|NCT01678820|3039627|Superiority or Other||Difference in least squares means|0.0||||0.99|2-Sided|95.0|-6.0|6.0|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651809|NCT01678820|3039627|Superiority or Other||Difference in least squares means|-18.1|||<|0.001|2-Sided|95.0|-24.2|-12.0|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651810|NCT01678820|3039628|Superiority or Other||Difference in least squares means|5.3||||0.286|2-Sided|95.0|-4.5|15.2|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651811|NCT01678820|3039628|Superiority or Other||Difference in least squares means|-25.6|||<|0.001|2-Sided|95.0|-35.6|-15.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651812|NCT01678820|3039629|Superiority or Other||Difference in least squares means|-29.2||||0.002|2-Sided|95.0|-47.9|-10.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651813|NCT01678820|3039629|Superiority or Other||Difference in least squares means|1.7||||0.856|2-Sided|95.0|-17.1|20.6|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651814|NCT01678820|3039630|Superiority or Other||Difference in least squares means|-0.62|||<|0.001|2-Sided|95.0|-0.95|-0.28|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment.|||
1651815|NCT01678820|3039632|Superiority or Other||Difference in percents|-4.3|||||2-Sided|95.0|-14.7|5.8|||||Based on Miettinen & Nurminen method||
1651816|NCT01678820|3039632|Superiority or Other||Difference in percents|-0.4|||||2-Sided|95.0|-10.2|9.3|||||Based on Miettinen & Nurminen method||
1651817|NCT01678820|3039633|Superiority or Other||Difference in least squares means|0.19||||0.267|2-Sided|95.0|-0.14|0.52|||Longitudinal Data Analysis Model|Based on a longitudinal model including terms for region, treatment, time, and the interaction of time by treatment|||
1651818|NCT01678807|3039634|Superiority or Other||Percent Difference|6.2|||||2-Sided|95.0|0.4|14.8|||||Estimate based on Miettinen & Nurminen method stratified by asthma status.||
1651819|NCT01678807|3039634|Superiority or Other||Percent Difference|6.2|||||2-Sided|95.0|0.4|14.8|||||Estimate based on Miettinen & Nurminen method stratified by asthma status.||
1651820|NCT01678807|3039635|Superiority or Other||Percent Difference|10.8|||||2-Sided|95.0|-6.4|27.4|||||Estimate based on Miettinen & Nurminen method stratified by asthma status.||
1651821|NCT01678807|3039635|Superiority or Other||Percent Difference|13.8|||||2-Sided|95.0|-3.4|30.3|||||Estimate based on Miettinen & Nurminen method stratified by asthma status.||
1651822|NCT01678560|3039636|Other|Exact Fisher test was used on the collected information from the limited population|Exact Fisher test|0.0039|||<|0.01|2-Sided|||||"Hypothesis: Patients with the higher AHI are more likely to become adherent to the PAP therapy.~Exact Fisher test was used on the collected information from the limited population"|Fisher Exact|Exact Fisher test was used on the collected information from the limited population||Exact Fisher test was used on the collected information from the limited population|Exact Fisher test was used on the collected information from the limited population
1651823|NCT01678560|3039637|Other|Exact Fisher test was used on the collected information from the limited population|Other[Fisher exact test statistic value]|0.0286|||<|0.01|2-Sided|||||Hypothesis - PAP treatment Adherence in the first 3 months of treatment predicts the PAP treatment Adherence in the next 9 months of treatment Exact Fisher test was used on the collected information from the limited population|Fisher Exact||Exact Fisher test was used on the collected information from the limited population.|Exact Fisher test was used on the collected information from the limited population|Exact Fisher test was used on the collected information from the limited population.
1651824|NCT01678560|3039638|Other|Exact Fisher test was used on the collected information from the limited population|Estimation Parameter Other[Fisher exact|1.0|||<|0.01|2-Sided|||||Hypothesis - Number of patients effectively treated with the PAP will be higher in the Wireless Group compared to the Usual Group Exact Fisher test was used on the collected information from the limited population.|Fisher Exact|||CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.|
1651852|NCT01677299|3039786|Superiority or Other||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|2-Sided|95.0|1.4|1.8|||Mixed Models Analysis||||
1651853|NCT01677299|3039787|Superiority or Other||Geo LSmean ratio (Day 5/Baseline)|1.9|||<|0.05|2-Sided|95.0|1.5|2.3|||Mixed Models Analysis||||
1653316|NCT01656850|3042325|Superiority or Other|||||||0.7758|||||||Mixed Models Analysis||||
1651825|NCT01678560|3039639|Other|Exact Fisher test was used on the collected information from the limited population|Fisher exact test statistic value|1.0|||<|0.01|2-Sided|||||"Hypothesis: Active continuous monitoring of PAP treatment in OSA (Wireless group) will result in improved adherence at 90 days compared to Usual Group.~Exact Fisher test was used on the collected information from the limited population."|Fisher Exact|Exact Fisher test was used on the information from the limited population||CPAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm|Exact Fisher test was used on the collected information from the limited population
1651826|NCT01678560|3039640|Other|Exact Fisher test was used on the collected information from the limited population|Fisher exact test statistic value|1.0|||<|0.01|2-Sided|||||Hypothesis: Active continuous monitoring of PAP treatment in OSA will result in improved adherence at 90 days Exact Fisher test was used on the collected information from the limited population.|Fisher Exact|Exact Fisher test was used on the information from the limited population.||PAP devices delivery to the patients was outsourced by the institution eliminating the point of recruitment for the study at our department. The recruitment was halted and the study proceeded with the follow-up of already recruited patients. As a result of the limited recruitment, planned statistical data analysis was not performed on the primary outcomes due to the smaller then expected number of subjects (expected 110 subjects in the Usual arm and 110 subjects in the Wireless arm.|Exact Fisher test was used on the collected information from the limited population.
1651827|NCT01678196|3039652|Superiority or Other||||||<|0.001|||||||ANCOVA|ANCOVA reflects change for Time 1 values (entered as the covariate) to Time 2 values (entered as the DV)|||
1651828|NCT01678196|3039653|Superiority or Other|||||||0.743|||||||ANCOVA|ANCOVA results include Time 1 scores as a covariate, thus reflecting change over time|||
1651829|NCT01678196|3039654|Superiority or Other|||||||0.67|||||||ANCOVA|ANCOVA reflects change from Time 1 scores (entered as covariate) to Time 2 Scores.|||
1651830|NCT01678196|3039655|Superiority or Other|||||||0.927|||||||Chi-squared||||
1651831|NCT01678131|3039669|Superiority or Other||Posterior Percentage Probability|100.0||||||||||||||The posterior percentage probability of the true success rate of the FNA procedure for the 3 combined treatment groups (n=29) was determined by a Bayesian calculation, using a Jeffrey's prior distribution (i.e. Beta [0.5,0.5]) on the true success rate. Neither P-values, nor confidence intervals are estimated in this analysis. The primary hypothesis was met if the posterior percentage probability was > 80% that the true success rate is at least 60%.|
1651832|NCT01677936|3039678|Superiority or Other||Mean Difference (Final Values)|8.7|||=|0||||||Compared with snacks, the 8.8 mmHg reduction with raisins met the a priori threshold for statistical significance.|t-test, 2 sided||||
1651833|NCT01677936|3039679|Superiority or Other||Mean Difference (Final Values)|23.0|||=|0||||||Compared to snacks, raisins reduced percent post-prandial glucose levels by 23%, which met the a priori threshold for statistical significance.|t-test, 2 sided||||
1651834|NCT01677910|3039685|Superiority||Mean Difference (Net)|-0.833|||<|0.001|2-Sided|95.0|-1.292|-0.374|||Wilcoxon rank sum||Mean difference is calculated as LX1606-Placebo|Primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the urinary 5-HIAA stratification at randomization.|
1651835|NCT01677910|3039685|Superiority||Mean Difference (Net)|-0.81|||<|0.001|2-Sided|95.0|-1.283|-0.337|||Wilcoxon rank sum||Mean difference is calculated as LX1606-Placebo|Primary analysis used a blocked 2-sample Wilcoxon rank sum statistic stratified by the urinary 5-HIAA stratification at randomization.|
1651836|NCT01677858|3039701|Other||Maximum Tolerated Dose (mg/m²)|70.0|||||2-Sided||||||||||
1651837|NCT01677507|3039715|Other||Mean Difference (Final Values)|0.03||||0.88|2-Sided|95.0|-0.4|0.4|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated|
1651838|NCT01677507|3039715|Other||Mean Difference (Final Values)|0.1||||0.52|2-Sided|95.0|-0.3|0.6|||t-test, 2 sided|paired t-test, 2 sided||Right Eye, treated vs. untreated|
1651839|NCT01677507|3039715|Other||Mean Difference (Final Values)|0.2||||0.15|2-Sided|95.0|-0.1|0.6|||t-test, 2 sided|paired t-test, 2 sided||Left eye, treated vs. untreated|
1651840|NCT01677507|3039715|Other||Mean Difference (Final Values)|0.4||||0.04|2-Sided|95.0|0.01|0.7|||t-test, 2 sided|paired t-test, 2 sided||Right Eye, treated vs. untreated|
1651841|NCT01677507|3039716|Other||Mean Difference (Final Values)|0.05||||0.54|2-Sided|95.0|-0.1|0.2|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated|
1651842|NCT01677507|3039716|Other||Mean Difference (Final Values)|0.01||||0.94|2-Sided|95.0|-0.2|0.2|||t-test, 2 sided|paired t-test||Right Eye, treated vs. untreated|
1651843|NCT01677507|3039716|Other||Median Difference (Final Values)|0.9||||0.0001|2-Sided|95.0|0.7|1.1|||t-test, 2 sided|paired t test, 2 sided||Left Eye, treated vs. untreated|
1651844|NCT01677507|3039716|Other||Median Difference (Final Values)|1.1||||0.0001|2-Sided|95.0|0.9|1.3|||t-test, 2 sided|paired t test, 2 sided||Right Eye treated to untreated|
1651845|NCT01677507|3039717|Other||Mean Difference (Final Values)|2.9||||0.0001|2-Sided|95.0|2.5|3.3|||t-test, 2 sided|paired t-test, 2 sided||Left Eye, treated vs. untreated|
1651846|NCT01677507|3039717|Other||Mean Difference (Final Values)|3.0||||0.0001|2-Sided|95.0|2.5|3.4|||t-test, 2 sided|paired t-test, 2 sided||Right Eye treated vs. untreated|
1651847|NCT01677507|3039717|Other||Mean Difference (Final Values)|2.8||||0.0001|2-Sided|95.0|2.5|3.2|||t-test, 2 sided|paired t-test, 2 sided||Left Eye treated vs. untreated|
1651848|NCT01677507|3039717|Other||Mean Difference (Final Values)|2.8||||0.0001|2-Sided|95.0|2.4|3.3|||t-test, 2 sided|Actually these are 2 sided paired t-tests.||Right Eye treated vs. untreated|
1651849|NCT01677299|3039786|Superiority or Other||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|2-Sided|95.0|1.4|1.6|||Mixed Models Analysis||||
1651850|NCT01677299|3039786|Superiority or Other||Geo LSmean ratio (Day 5/Baseline)|1.5|||<|0.05|2-Sided|95.0|1.3|1.6|||Mixed Models Analysis||||
1651851|NCT01677299|3039786|Superiority or Other||Geo LSmean ratio (Day 5/Baseline)|1.4|||<|0.05|2-Sided|95.0|1.2|1.6|||Mixed Models Analysis||||
1651854|NCT01677299|3039787|Superiority or Other||Geo LSmean ratio (Day 5/Baseline)|1.7|||<|0.05|2-Sided|95.0|1.4|2.0|||Mixed Models Analysis||||
1651855|NCT01677299|3039787|Superiority or Other||Geo LSmean ratio of (Day 5/Baseline)|1.9|||<|0.05|2-Sided|95.0|1.5|2.3|||Mixed Models Analysis||||
1651856|NCT01677299|3039787|Superiority or Other||Geometric LS mean ration|1.6|||<|0.05|2-Sided|95.0|1.4|1.9|||Mixed Models Analysis||||
1651857|NCT01677299|3039788|Superiority or Other||LS mean diff (Day 5 - Baseline)|-21.0|||<|0.05|2-Sided|95.0|-31.0|-11.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment D.|||
1651858|NCT01677299|3039788|Superiority or Other||LS mean diff (Day 5 - Baseline)|-16.0|||<|0.05|2-Sided|95.0|-24.0|-8.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment C.|||
1651859|NCT01677299|3039788|Superiority or Other||LS mean diff (Day 5 - Baseline)|-20.0|||<|0.05|2-Sided|95.0|-30.0|-9.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment B.|||
1651860|NCT01677299|3039788|Superiority or Other||LS mean diff (Day 5 - Baseline)|-22.5|||<|0.05|2-Sided|95.0|-37.0|-8.0|||Mixed Models Analysis|Change in fasting plasma glucose from Baseline to Day 5 (end of treatment) for treatment A.|||
1651861|NCT01677286|3039790|Other|P-values and confidence intervals are not adjusted for multiple testing|Change in outcome measure|0.091||||0.603|2-Sided|95.0|-0.285|0.466|||Mixed Models Analysis|degrees of freedom = 10||Proteinuria (g/24 hours), baseline versus end study levels.|
1651862|NCT01677286|3039791|Other|P-values and confidence intervals are not adjusted for multiple testing|Change in outcome measure|-7.39||||0.017|2-Sided|95.0|-13.12|-1.67|||Mixed Models Analysis|degrees of freedom = 10||Creatinine clearance, baseline versus end study levels.|
1651863|NCT01677286|3039792|Other|P-values and confidence intervals are not adjusted for multiple testing|Mean outcome change|0.0072||||0.34|2-Sided|95.0|-0.009|0.0234|||Mixed Models Analysis|degrees of freedom = 12||Troponin I ng/mL, baseline versus end study levels.|
1651864|NCT01677286|3039793|Other|P-values and confidence intervals are not adjusted for multiple testing|Mean outcome change|171.0||||0.035|2-Sided|95.0|14.1|328.0|||Mixed Models Analysis|degrees of freedom = 12||BNP pg/mL, baseline versus end study values|
1651865|NCT01677182|3039795|Superiority or Other||Odds Ratio (OR)|0.865||||0.553|2-Sided|95.0|0.536|1.397||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic||||
1651866|NCT01677182|3039795|Superiority or Other||Odds Ratio (OR)|0.978||||0.927|2-Sided|95.0|0.606|1.577||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic||||
1651867|NCT01677182|3039796|Superiority or Other||Odds Ratio (OR)|0.886||||0.575|2-Sided|95.0|0.58|1.352||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic||||
1651868|NCT01677182|3039796|Superiority or Other||Odds Ratio (OR)|0.998||||0.994|2-Sided|95.0|0.651|1.53||Odds ratio, 95% confidence intervals and p-values are analyzed from logistic regression with explanatory variables for treatment and baseline MADRS total score.|Regression, Logistic||||
1651869|NCT01677182|3039797|Superiority or Other||Least Squares Mean Difference|0.1|Standard Error of the Mean|1.63||0.472|2-Sided|97.5|-3.6|3.8||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651870|NCT01677182|3039797|Superiority or Other||Least Squares Mean Difference|-0.8|Standard Error of the Mean|1.64||0.696|2-Sided|97.5|-4.5|2.8||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651871|NCT01677182|3039798|Superiority or Other||Least Squares Mean Difference|0.3|Standard Error of the Mean|0.7||0.655|2-Sided|97.5|-1.3|1.9||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651872|NCT01677182|3039798|Superiority or Other||Least Squares Mean Difference|0.6|Standard Error of the Mean|0.7||0.422|2-Sided|97.5|-1.0|2.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651873|NCT01677182|3039799|Superiority or Other||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.51||0.791|2-Sided|97.5|-1.3|1.0||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651874|NCT01677182|3039799|Superiority or Other||Least Squares Mean Difference|0.8|Standard Error of the Mean|0.51||0.119|2-Sided|97.5|-0.4|2.0||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651875|NCT01677182|3039800|Superiority or Other||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.12||0.673|2-Sided|97.5|-0.3|0.2||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651876|NCT01677182|3039800|Superiority or Other||Least Squares Mean Difference|0.1|Standard Error of the Mean|0.12||0.653|2-Sided|97.5|-0.2|0.3||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651877|NCT01677182|3039801|Superiority or Other||Least Squares Mean Difference|-0.2|Standard Error of the Mean|0.12||0.171|2-Sided|97.5|-0.4|0.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651878|NCT01677182|3039801|Superiority or Other||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.12||0.792|2-Sided|97.5|-0.2|0.3||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651879|NCT01677182|3039802|Superiority or Other||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.27||0.642|2-Sided|97.5|-0.7|0.5||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651880|NCT01677182|3039802|Superiority or Other||Least Squares Mean Difference|0.5|Standard Error of the Mean|0.27||0.088|2-Sided|97.5|-0.1|1.1||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651881|NCT01677182|3039803|Superiority or Other||Least Squares Mean Difference|-0.4|Standard Error of the Mean|0.97||0.329|2-Sided|97.5|-2.6|1.7||MMRM model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651882|NCT01677182|3039803|Superiority or Other||Least Squares Mean Differences|0.8|Standard Error of the Mean|0.98||0.783|2-Sided|97.5|-1.4|3.0||Mixed Model Repeated Measures (MMRM) model with baseline by week interaction, pooled center, week, treatment, baseline, and week by treatment interaction as factors was used for the analysis.|Mixed Model Repeated Measures||||
1651883|NCT01676909|3039806|Superiority|||||||0.222|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651884|NCT01676909|3039807|Superiority|||||||0.285|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651885|NCT01676909|3039808|Superiority|||||||0.852|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651886|NCT01676909|3039809|Superiority|||||||0.099|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651887|NCT01676909|3039810|Superiority|||||||0.045|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651888|NCT01676909|3039811|Superiority|||||||0.134|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651889|NCT01676909|3039812|Superiority|||||||0.709|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651890|NCT01676909|3039813|Superiority|||||||0.011|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651891|NCT01676909|3039814|Superiority|||||||0.238|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651892|NCT01676909|3039815|Superiority|||||||0.038|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651941|NCT01675427|3039982|Superiority or Other||||||<|0.0001||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes|
1652401|NCT01672970|3040369|Superiority or Other|||||||0|||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3|
1651893|NCT01676909|3039816|Superiority|||||||0.459|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651894|NCT01676909|3039817|Superiority|||||||0.446|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651895|NCT01676909|3039818|Superiority|||||||0.727|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651896|NCT01676909|3039819|Superiority|||||||0.004|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651897|NCT01676909|3039820|Superiority|||||||0.563|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651898|NCT01676909|3039821|Superiority|||||||0.342|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651899|NCT01676909|3039822|Superiority|||||||0.142|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651900|NCT01676909|3039823|Superiority|||||||0.667|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651901|NCT01676909|3039824|Superiority|||||||0.326|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651902|NCT01676909|3039825|Superiority|||||||0.762|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651903|NCT01676909|3039826|Superiority|||||||0.006|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651904|NCT01676909|3039827|Superiority|||||||0.699|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651905|NCT01676909|3039828|Superiority|||||||0.544|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1652402|NCT01672970|3040370|Superiority or Other|||||||0|||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6|
1651906|NCT01676909|3039829|Superiority|||||||0.038|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651907|NCT01676909|3039830|Superiority||||||<|0.0001|||||||Mixed Models Analysis|||The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.|
1651908|NCT01676909|3039831|Superiority|||||||0.64|||||||Mixed Models Analysis|||A logistic mixed effects model over two 6-month time periods (prior to baseline and between baseline and the 6-month follow-up visit) was used. Terms in the model included group, binary time (pre-f/u versus pre-baseline), and group by time interaction. Two-sided alpha = .05 level tests were used. The hypothesis that the proportion with ER visits would decrease in the Living Well group versus the control group was tests by test of the interaction term.|
1651909|NCT01676909|3039832|Superiority|||||||0.032|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.|
1651910|NCT01676909|3039833|Superiority|||||||0.026|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.|
1651911|NCT01676909|3039834|Superiority|||||||0.362|||||||Mixed Models Analysis|||To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.|
1651912|NCT01676311|3039899|Superiority|||||||1||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of neurological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Neurological side effects statistical analysis|
1651913|NCT01676311|3039899|Superiority|||||||0.41||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of musculoskeletal side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Musculoskeletal side effects statistical analysis|
1651914|NCT01676311|3039899|Superiority|||||||0.27||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of hematological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Hematological side effects statistical analysis|
1651915|NCT01676311|3039899|Superiority|||||||0.54||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of genitourinary/neurological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects|Chi-squared test and permutation test|||Genitourinary/neurological side effects statistical analysis|
1651916|NCT01676311|3039899|Superiority|||||||0.73||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of gastrointestinal side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Gastrointestinal side effects statistical analysis|
1651917|NCT01676311|3039899|Superiority|||||||0.81||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of dermatological side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of dermatological side effects.|Chi-squared test and permutation test|||Dermatological side effects statistical analysis|
1651918|NCT01676311|3039899|Superiority|||||||0.81||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of cardiac-respiratory side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of these side effects.|Chi-squared test and permutation test|||Cardiac-respiratory side effects statistical analysis|
1651919|NCT01676311|3039899|Superiority|||||||0.44||||||A chi-squared test with factors of group (Huperzine A, placebo) and occurrence of behavioral side effects (yes, no) were performed. A permutation test was used to assess the effect of Huperzine A on the incidence of behavioral side effects.|Chi-squared test and permutation test|||Behavioral side effects statistical analysis|
1651920|NCT01676311|3039900|Superiority|||||||0.48||||||A chi-square test with factors of group (Huperzine A, placebo) and occurrence of seizure (yes, no) was performed. A permutation test was the used to assess the effect of Huperzine A on the prevalence of seizures.|Chi-squared test and permutation test||||
1651942|NCT01675427|3039982|Superiority or Other||||||<|0.2707||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes|
1651943|NCT01675427|3039982|Superiority or Other||||||<|0.0064||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4|
1651944|NCT01675427|3039982|Superiority or Other||||||<|0.3516||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3|
1651921|NCT01676311|3039903|Superiority|||||||0.42||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group (Huperzine A, placebo), baseline CVLT-II-long delay free recall (LDFR) score, outcome (CVLT-II-LDFR at week 12) and covariates (Beck Depression Index, time post-injury, British Columbia Postconcussion Symptom Inventory). Regression analyses were repeated, permuting data observations for each outcome i.e. we permuted the labels (Huperzine A or placebo) among the data observations and re-ran the regression.|
1651922|NCT01676311|3039903|Superiority|||||||0.38||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group (Huperzine A, placebo), baseline CVLT-II-short delay free recall (SDFR) score, outcome (CVLT-II-SDFR at week 12) and covariates (Beck Depression Index, time post-injury, British Columbia Postconcussion Symptom Inventory). Regression analyses were repeated, permuting data observations for each outcome i.e. we permuted the labels (Huperzine A or placebo) among the data observations and re-ran the regression.|
1651923|NCT01676311|3039903|Superiority|||||||0.38||||||For each permutation of the data, relevant result was saved and the corresponding p-value represents the proportion of results at least as extreme as observed in the original data.|Regression, Linear|||Regression analysis was run incorporating group, CVLT-II-total learning score at baseline and week 12, and covariates (Beck Depression Index [BDI], time post-injury, British Columbia Postconcussion Symptom Inventory [BC-PSI]). Regression analyses were repeated, permuting data observations for each outcome. The BDI and BC-PSI are covariates in the regression model and not pre-specified Primary and Secondary Outcome Measures.|
1651924|NCT01676220|3039915|Superiority or Other||LS Mean Difference|0.17|Standard Error of the Mean|0.224|||2-Sided|95.0|-0.275|0.605||||||Change in pre-injection SMPG was analyzed using MMRM model with treatment groups, strata of screening HbA1c (<8.0, >=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline preinjection SMPG value and baseline preinjection SMPG value-by-visit interaction as continuous fixed covariates.|
1651925|NCT01676220|3039916|Superiority or Other||Risk Ratio (RR)|0.89||||0.4536|2-Sided|95.0|0.66|1.2|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method stratified by randomization strata of screening HbA1c (<8.0, >=8.0%), randomization strata of geographical region (Non-Japan; Japan).|
1651926|NCT01676220|3039917|Non-Inferiority or Equivalence|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is <0.4%.~Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is <0."|Least Squares (LS) Mean Difference|0.04|Standard Error of the Mean|0.067|||2-Sided|95.0|-0.09|0.174||||||Analysis was performed using mixed model for repeated measurements (MMRM) with treatment groups, strata of screening HbA1c (<8.0, >=8.0%), geographical region (Non-Japan; Japan), visit and visit-by-treatment groups interaction as fixed categorical effects; baseline HbA1c and baseline HbA1c-by-visit interaction as continuous fixed covariates.|
1651927|NCT01676116|3039926|Superiority or Other||Treatment contrast|-0.94|||<|0.001|2-Sided|95.0|-1.11|-0.78|||ANCOVA||||
1651928|NCT01675661|3039933|Superiority or Other||Odds Ratio (OR)|1.0||||0.985|2-Sided|95.0|0.63|1.59|||Regression, Logistic|OR=1.00||For the primary outcome measure, a repeated-measures logistic regression model was used to analyze the odds of a negative urine cannabinoid test as an indicator of abstinence across all 12 weeks of treatment. A generalized estimating equations (GEEs) were used to adjust for this correlation with multiple samples per participant. The model for the primary analysis included the main effect of treatment, main effect of time, site effects, effect of smoking tobacco, and timeXtreatment interaction.|
1651929|NCT01675427|3039980|Superiority or Other|||||||0.5769||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes|
1651930|NCT01675427|3039980|Superiority or Other|||||||0.3927||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes|
1651931|NCT01675427|3039980|Superiority or Other|||||||0.2901||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4|
1651932|NCT01675427|3039980|Superiority or Other|||||||0.4805||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3|
1651933|NCT01675427|3039980|Superiority or Other|||||||0.2427||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2|
1651934|NCT01675427|3039980|Superiority or Other|||||||0.8234||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1|
1651935|NCT01675427|3039981|Superiority or Other|||||||0.0406||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes|
1651936|NCT01675427|3039981|Superiority or Other|||||||0.4543||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes|
1651937|NCT01675427|3039981|Superiority or Other|||||||0.861||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4|
1651938|NCT01675427|3039981|Superiority or Other|||||||0.3944||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3|
1651939|NCT01675427|3039981|Superiority or Other|||||||0.7176||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2|
1651940|NCT01675427|3039981|Superiority or Other|||||||0.0634||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1|
1651945|NCT01675427|3039982|Superiority or Other||||||<|0.0563||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2|
1651946|NCT01675427|3039982|Superiority or Other||||||<|0.0081||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1|
1651947|NCT01675427|3039983|Superiority or Other|||||||0.0001||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Total genotypes|
1651948|NCT01675427|3039983|Superiority or Other|||||||0.2857||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||Other genotypes|
1651949|NCT01675427|3039983|Superiority or Other|||||||0.2293||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G4|
1651950|NCT01675427|3039983|Superiority or Other|||||||0.0114||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G3|
1651951|NCT01675427|3039983|Superiority or Other|||||||0.5319||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G2|
1651952|NCT01675427|3039983|Superiority or Other|||||||0.0021||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three ITPA genotype categories|Cochran-Armitage Trend Test|||G1|
1651953|NCT01675427|3039984|Superiority or Other|||||||0.1667||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1651954|NCT01675427|3039984|Superiority or Other|||||||0.3268||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1651955|NCT01675427|3039984|Superiority or Other|||||||0.0196||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1651956|NCT01675427|3039984|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1651957|NCT01675427|3039985|Superiority or Other|||||||0.0493||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1651958|NCT01675427|3039985|Superiority or Other|||||||0.0394||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1651959|NCT01675427|3039985|Superiority or Other|||||||0.0002||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1651960|NCT01675427|3039985|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1651961|NCT01675427|3039986|Superiority or Other|||||||0.1986||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4|
1651962|NCT01675427|3039986|Superiority or Other|||||||0.7817||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3|
1651963|NCT01675427|3039986|Superiority or Other|||||||0.0827||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2|
1651964|NCT01675427|3039986|Superiority or Other||||||<|0.0001||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1|
1651965|NCT01675427|3039987|Superiority or Other|||||||0.295||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4|
1651966|NCT01675427|3039987|Superiority or Other|||||||0.7658||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3|
1651967|NCT01675427|3039987|Superiority or Other|||||||0.0421||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2|
1651968|NCT01675427|3039987|Superiority or Other||||||<|0.0001||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1|
1651969|NCT01675427|3039988|Superiority or Other|||||||0.0412||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1651970|NCT01675427|3039988|Superiority or Other|||||||0.1595||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1651971|NCT01675427|3039988|Superiority or Other|||||||0.033||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1651972|NCT01675427|3039988|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1651973|NCT01675427|3039989|Superiority or Other|||||||0.0253||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1651974|NCT01675427|3039989|Superiority or Other|||||||0.1717||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1651975|NCT01675427|3039989|Superiority or Other|||||||0.0012||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1651976|NCT01675427|3039989|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1651977|NCT01675427|3039990|Superiority or Other|||||||0.0007||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1651978|NCT01675427|3039990|Superiority or Other|||||||0.1052||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1651979|NCT01675427|3039990|Superiority or Other|||||||0.0151||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4|
1651980|NCT01675427|3039991|Superiority or Other|||||||0.9778||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3|
1651981|NCT01675427|3039991|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2|
1651982|NCT01675427|3039991|Superiority or Other||||||<|0.0097||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1|
1651983|NCT01675427|3039992|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1651984|NCT01675427|3039992|Superiority or Other||||||<|0.7361||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1651985|NCT01675427|3039992|Superiority or Other||||||<|0.2564||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4|
1651986|NCT01675427|3039993|Superiority or Other|||||||0.3472||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3|
1651987|NCT01675427|3039993|Superiority or Other|||||||0.9999||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2|
1651988|NCT01675427|3039993|Superiority or Other|||||||0.0065||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1|
1651989|NCT01675427|3039994|Superiority or Other|||||||0.0006||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1651990|NCT01675427|3039994|Superiority or Other|||||||0.8303||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1651991|NCT01675427|3039994|Superiority or Other|||||||0.9734||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4|
1651992|NCT01675427|3039995|Superiority or Other|||||||0.7472||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3|
1651993|NCT01675427|3039995|Superiority or Other|||||||0.0119||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2|
1651994|NCT01675427|3039995|Superiority or Other|||||||0.1236||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1|
1651995|NCT01675427|3039996|Superiority or Other|||||||0.0948||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1651996|NCT01675427|3039996|Superiority or Other|||||||0.3675||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1651997|NCT01675427|3039996|Superiority or Other|||||||0.1158||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4|
1651998|NCT01675427|3039997|Superiority or Other|||||||0.0226||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3|
1651999|NCT01675427|3039997|Superiority or Other|||||||0.1947||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2|
1652000|NCT01675427|3039997|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1|
1652001|NCT01675427|3039998|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1652002|NCT01675427|3039998|Superiority or Other||||||<|0.5246||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1652003|NCT01675427|3039998|Superiority or Other||||||<|0.3824||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4|
1652004|NCT01675427|3039998|Superiority or Other||||||<|0.4423||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3|
1652005|NCT01675427|3039998|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2|
1652006|NCT01675427|3039998|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1|
1652007|NCT01675427|3039999|Superiority or Other|||||||0.0005||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1652008|NCT01675427|3039999|Superiority or Other|||||||0.5317||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1652009|NCT01675427|3039999|Superiority or Other|||||||0.026||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4|
1652010|NCT01675427|3039999|Superiority or Other|||||||0.1485||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3|
1652011|NCT01675427|3039999|Superiority or Other|||||||0.8543||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2|
1652012|NCT01675427|3039999|Superiority or Other|||||||0.1834||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1|
1652013|NCT01675427|3040000|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1652014|NCT01675427|3040000|Superiority or Other||||||<|0.8124||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1652015|NCT01675427|3040000|Superiority or Other||||||<|0.6935||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4|
1652016|NCT01675427|3040000|Superiority or Other||||||<|0.8579||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3|
1652017|NCT01675427|3040000|Superiority or Other||||||<|0.1637||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2|
1652018|NCT01675427|3040000|Superiority or Other||||||<|0.0003||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1|
1652019|NCT01675427|3040001|Superiority or Other|||||||0.0067||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1652020|NCT01675427|3040001|Superiority or Other|||||||0.7672||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1652021|NCT01675427|3040001|Superiority or Other|||||||0.67||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G4|
1652022|NCT01675427|3040001|Superiority or Other|||||||0.9829||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G3|
1652023|NCT01675427|3040001|Superiority or Other|||||||0.0425||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G2|
1652024|NCT01675427|3040001|Superiority or Other|||||||0.0018||||||Pearson Chi-Square Test for differences in the ITPA distribution between the nominal categories of interest|Chi-squared|||G1|
1652025|NCT01675427|3040002|Superiority or Other|||||||0.0066||||||Pearson Chi-Square Tests for association between the two variables|Chi-squared||||
1652026|NCT01675427|3040003|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Tests for association between the two variables|Chi-squared||||
1652027|NCT01675427|3040004|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Tests for association between the two variables|Chi-squared||||
1652028|NCT01675427|3040005|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Tests for association between the two variables|Chi-squared||||
1652029|NCT01675427|3040006|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1652030|NCT01675427|3040006|Superiority or Other||||||<|0.7358||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1652031|NCT01675427|3040006|Superiority or Other||||||<|0.3465||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4|
1652032|NCT01675427|3040007|Superiority or Other|||||||0.5127||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3|
1652033|NCT01675427|3040007|Superiority or Other|||||||0.0048||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2|
1652034|NCT01675427|3040007|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1|
1652035|NCT01675427|3040008|Superiority or Other|||||||0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1652036|NCT01675427|3040008|Superiority or Other|||||||0.6059||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1652037|NCT01675427|3040008|Superiority or Other|||||||0.2611||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4|
1652038|NCT01675427|3040009|Superiority or Other|||||||0.1185||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3|
1652039|NCT01675427|3040009|Superiority or Other|||||||0.6852||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2|
1652040|NCT01675427|3040009|Superiority or Other|||||||0.0381||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1|
1652041|NCT01675427|3040010|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1652042|NCT01675427|3040010|Superiority or Other||||||<|0.3437||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1652043|NCT01675427|3040010|Superiority or Other||||||<|0.5117||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4|
1652044|NCT01675427|3040011|Superiority or Other|||||||0.5522||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3|
1652045|NCT01675427|3040011|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2|
1652046|NCT01675427|3040011|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1|
1652047|NCT01675427|3040012|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1652048|NCT01675427|3040012|Superiority or Other||||||<|0.0474||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1652049|NCT01675427|3040012|Superiority or Other||||||<|0.0637||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4|
1652050|NCT01675427|3040013|Superiority or Other|||||||0.3672||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3|
1652051|NCT01675427|3040013|Superiority or Other|||||||0.8373||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2|
1652052|NCT01675427|3040013|Superiority or Other|||||||0.0103||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1|
1652053|NCT01675427|3040014|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1652054|NCT01675427|3040014|Superiority or Other||||||<|0.2032||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1652055|NCT01675427|3040014|Superiority or Other||||||<|0.8668||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4|
1652056|NCT01675427|3040014|Superiority or Other||||||<|0.482||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3|
1652057|NCT01675427|3040014|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2|
1652058|NCT01675427|3040014|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1|
1652059|NCT01675427|3040015|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1652060|NCT01675427|3040015|Superiority or Other||||||<|0.2164||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1652061|NCT01675427|3040015|Superiority or Other||||||<|0.7993||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4|
1652062|NCT01675427|3040015|Superiority or Other||||||<|0.2356||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3|
1652063|NCT01675427|3040015|Superiority or Other||||||<|0.3857||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2|
1652064|NCT01675427|3040015|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1|
1652065|NCT01675427|3040016|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1652066|NCT01675427|3040016|Superiority or Other||||||<|0.0372||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1652067|NCT01675427|3040016|Superiority or Other||||||<|0.6593||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4|
1652068|NCT01675427|3040016|Superiority or Other||||||<|0.5275||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3|
1652069|NCT01675427|3040016|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2|
1652070|NCT01675427|3040016|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1|
1652071|NCT01675427|3040017|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Total genotypes|
1652072|NCT01675427|3040017|Superiority or Other||||||<|0.0525||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||Other genotypes|
1652073|NCT01675427|3040017|Superiority or Other||||||<|0.0467||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G4|
1652074|NCT01675427|3040017|Superiority or Other||||||<|0.2041||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G3|
1652075|NCT01675427|3040017|Superiority or Other||||||<|0.3572||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G2|
1652076|NCT01675427|3040017|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Test for differences in the IL28B distribution between the nominal categories of interest|Chi-squared|||G1|
1652077|NCT01675427|3040018|Superiority or Other|||||||0.0005||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652078|NCT01675427|3040018|Superiority or Other|||||||0.5529||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652079|NCT01675427|3040018|Superiority or Other|||||||0.2993||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652080|NCT01675427|3040018|Superiority or Other|||||||0.2401||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652081|NCT01675427|3040018|Superiority or Other|||||||0.2808||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652082|NCT01675427|3040018|Superiority or Other|||||||0.0059||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652083|NCT01675427|3040019|Superiority or Other|||||||0.0041||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652084|NCT01675427|3040019|Superiority or Other|||||||0.9305||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652085|NCT01675427|3040019|Superiority or Other|||||||0.4162||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652086|NCT01675427|3040019|Superiority or Other|||||||0.0635||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652087|NCT01675427|3040019|Superiority or Other|||||||0.1009||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652088|NCT01675427|3040019|Superiority or Other|||||||0.0671||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652089|NCT01675427|3040020|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652090|NCT01675427|3040020|Superiority or Other||||||<|0.4492||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652091|NCT01675427|3040020|Superiority or Other||||||<|0.4144||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652092|NCT01675427|3040020|Superiority or Other||||||<|0.5878||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652093|NCT01675427|3040020|Superiority or Other||||||<|0.2017||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652094|NCT01675427|3040020|Superiority or Other||||||<|0.0002||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652095|NCT01675427|3040021|Superiority or Other|||||||0.0076||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652096|NCT01675427|3040021|Superiority or Other|||||||0.8578||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652097|NCT01675427|3040021|Superiority or Other|||||||0.7044||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652098|NCT01675427|3040021|Superiority or Other|||||||0.0356||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652099|NCT01675427|3040021|Superiority or Other|||||||0.0018||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652100|NCT01675427|3040021|Superiority or Other|||||||0.3609||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652101|NCT01675427|3040022|Superiority or Other|||||||0.0003||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652102|NCT01675427|3040022|Superiority or Other|||||||0.3215||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652103|NCT01675427|3040022|Superiority or Other|||||||0.3346||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652104|NCT01675427|3040022|Superiority or Other|||||||0.0017||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652105|NCT01675427|3040022|Superiority or Other|||||||0.0034||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652106|NCT01675427|3040022|Superiority or Other|||||||0.0247||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652107|NCT01675427|3040023|Superiority or Other|||||||0.0013||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652108|NCT01675427|3040023|Superiority or Other|||||||0.2927||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652109|NCT01675427|3040023|Superiority or Other|||||||0.1951||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652110|NCT01675427|3040023|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652111|NCT01675427|3040023|Superiority or Other||||||<|0.4367||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652112|NCT01675427|3040023|Superiority or Other||||||<|0.0688||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652113|NCT01675427|3040024|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652114|NCT01675427|3040024|Superiority or Other||||||<|0.2372||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652115|NCT01675427|3040024|Superiority or Other||||||<|0.7821||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652116|NCT01675427|3040024|Superiority or Other||||||<|0.0106||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652117|NCT01675427|3040024|Superiority or Other||||||<|0.0003||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652118|NCT01675427|3040024|Superiority or Other||||||<|0.0002||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652119|NCT01675427|3040025|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652120|NCT01675427|3040025|Superiority or Other||||||<|0.2185||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652121|NCT01675427|3040025|Superiority or Other||||||<|0.536||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652122|NCT01675427|3040025|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652123|NCT01675427|3040025|Superiority or Other||||||<|0.0054||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652124|NCT01675427|3040025|Superiority or Other||||||<|0.1894||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652125|NCT01675427|3040026|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652126|NCT01675427|3040026|Superiority or Other||||||<|0.3217||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652127|NCT01675427|3040026|Superiority or Other||||||<|0.7166||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652128|NCT01675427|3040026|Superiority or Other||||||<|0.0013||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652129|NCT01675427|3040026|Superiority or Other||||||<|0.002||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652130|NCT01675427|3040026|Superiority or Other||||||<|0.0007||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652131|NCT01675427|3040027|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652132|NCT01675427|3040027|Superiority or Other||||||<|0.9932||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652133|NCT01675427|3040027|Superiority or Other||||||<|0.5588||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652134|NCT01675427|3040027|Superiority or Other||||||<|0.0013||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652135|NCT01675427|3040027|Superiority or Other||||||<|0.6291||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652136|NCT01675427|3040027|Superiority or Other||||||<|0.0098||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652137|NCT01675427|3040028|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652138|NCT01675427|3040028|Superiority or Other||||||<|0.2264||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652139|NCT01675427|3040028|Superiority or Other||||||<|0.098||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652140|NCT01675427|3040028|Superiority or Other||||||<|0.011||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652141|NCT01675427|3040028|Superiority or Other||||||<|0.0005||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652142|NCT01675427|3040028|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652143|NCT01675427|3040029|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652144|NCT01675427|3040029|Superiority or Other||||||<|0.3597||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652145|NCT01675427|3040029|Superiority or Other||||||<|0.3885||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652146|NCT01675427|3040029|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652147|NCT01675427|3040029|Superiority or Other||||||<|0.0061||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652148|NCT01675427|3040029|Superiority or Other||||||<|0.0007||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652149|NCT01675427|3040030|Superiority or Other|||||||0.002||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652150|NCT01675427|3040030|Superiority or Other|||||||0.5506||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652151|NCT01675427|3040030|Superiority or Other|||||||0.0847||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652152|NCT01675427|3040030|Superiority or Other|||||||0.5793||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652153|NCT01675427|3040030|Superiority or Other|||||||0.189||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652154|NCT01675427|3040030|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652155|NCT01675427|3040031|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652156|NCT01675427|3040031|Superiority or Other||||||<|0.955||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652157|NCT01675427|3040031|Superiority or Other||||||<|0.3031||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652158|NCT01675427|3040031|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652159|NCT01675427|3040031|Superiority or Other||||||<|0.2132||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652160|NCT01675427|3040031|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652161|NCT01675427|3040032|Superiority or Other|||||||0.4023||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652162|NCT01675427|3040032|Superiority or Other|||||||0.3772||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652163|NCT01675427|3040032|Superiority or Other|||||||0.1211||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652164|NCT01675427|3040032|Superiority or Other|||||||0.0566||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652165|NCT01675427|3040032|Superiority or Other|||||||0.4207||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652166|NCT01675427|3040033|Superiority or Other|||||||0.1148||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652167|NCT01675427|3040033|Superiority or Other|||||||1||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652168|NCT01675427|3040033|Superiority or Other|||||||0.5472||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652169|NCT01675427|3040033|Superiority or Other|||||||0.0291||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652170|NCT01675427|3040033|Superiority or Other|||||||0.8864||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652171|NCT01675427|3040033|Superiority or Other|||||||0.0017||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652172|NCT01675427|3040034|Superiority or Other|||||||0.9026||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652173|NCT01675427|3040034|Superiority or Other|||||||0.3422||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652174|NCT01675427|3040034|Superiority or Other|||||||0.5261||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652175|NCT01675427|3040034|Superiority or Other|||||||0.0016||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652176|NCT01675427|3040034|Superiority or Other|||||||0.7454||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652177|NCT01675427|3040035|Superiority or Other|||||||0.9159||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652178|NCT01675427|3040035|Superiority or Other|||||||0.1649||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652179|NCT01675427|3040035|Superiority or Other|||||||0.6165||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652180|NCT01675427|3040035|Superiority or Other|||||||0.0634||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652181|NCT01675427|3040035|Superiority or Other|||||||0.0899||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652182|NCT01675427|3040035|Superiority or Other|||||||0.0605||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652183|NCT01675427|3040036|Superiority or Other|||||||0.6603||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652184|NCT01675427|3040036|Superiority or Other|||||||0.5784||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652185|NCT01675427|3040036|Superiority or Other|||||||0.1574||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652186|NCT01675427|3040036|Superiority or Other|||||||0.2566||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652187|NCT01675427|3040036|Superiority or Other|||||||0.1622||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652188|NCT01675427|3040036|Superiority or Other|||||||0.8622||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652189|NCT01675427|3040037|Superiority or Other|||||||0.714||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652190|NCT01675427|3040037|Superiority or Other|||||||0.3519||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652191|NCT01675427|3040037|Superiority or Other|||||||0.2246||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652192|NCT01675427|3040037|Superiority or Other|||||||0.0175||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652193|NCT01675427|3040037|Superiority or Other|||||||0.5507||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652194|NCT01675427|3040037|Superiority or Other|||||||0.9887||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652195|NCT01675427|3040038|Superiority or Other|||||||0.0748||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652196|NCT01675427|3040038|Superiority or Other|||||||0.3878||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652197|NCT01675427|3040038|Superiority or Other|||||||0.5387||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652198|NCT01675427|3040038|Superiority or Other|||||||0.0478||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652199|NCT01675427|3040038|Superiority or Other|||||||0.2943||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652200|NCT01675427|3040038|Superiority or Other|||||||0.251||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652201|NCT01675427|3040039|Superiority or Other|||||||0.4237||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652202|NCT01675427|3040039|Superiority or Other|||||||0.3404||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652203|NCT01675427|3040039|Superiority or Other|||||||0.9393||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652204|NCT01675427|3040039|Superiority or Other|||||||0.0463||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652205|NCT01675427|3040039|Superiority or Other|||||||0.5469||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652206|NCT01675427|3040039|Superiority or Other|||||||0.5348||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652207|NCT01675427|3040040|Superiority or Other|||||||0.2646||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652208|NCT01675427|3040040|Superiority or Other|||||||0.2846||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652209|NCT01675427|3040040|Superiority or Other|||||||0.3492||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652210|NCT01675427|3040040|Superiority or Other|||||||0.8457||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652211|NCT01675427|3040040|Superiority or Other|||||||0.2054||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652212|NCT01675427|3040040|Superiority or Other|||||||0.3709||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652213|NCT01675427|3040041|Superiority or Other|||||||0.2925||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652214|NCT01675427|3040041|Superiority or Other|||||||0.161||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652215|NCT01675427|3040041|Superiority or Other|||||||0.5833||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652216|NCT01675427|3040041|Superiority or Other|||||||0.0578||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652217|NCT01675427|3040041|Superiority or Other|||||||0.3135||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652218|NCT01675427|3040041|Superiority or Other|||||||0.8686||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652219|NCT01675427|3040042|Superiority or Other|||||||0.0507||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652220|NCT01675427|3040042|Superiority or Other|||||||0.383||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652221|NCT01675427|3040042|Superiority or Other|||||||0.5937||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652222|NCT01675427|3040042|Superiority or Other|||||||0.1604||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652403|NCT01672970|3040370|Superiority or Other|||||||0|||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3|
1652223|NCT01675427|3040042|Superiority or Other|||||||0.4674||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652224|NCT01675427|3040042|Superiority or Other|||||||0.0911||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652225|NCT01675427|3040043|Superiority or Other|||||||0.7262||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652226|NCT01675427|3040043|Superiority or Other|||||||0.1525||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652227|NCT01675427|3040043|Superiority or Other|||||||0.4485||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652228|NCT01675427|3040043|Superiority or Other|||||||0.1192||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652229|NCT01675427|3040043|Superiority or Other|||||||0.1616||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652230|NCT01675427|3040043|Superiority or Other|||||||0.1981||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652231|NCT01675427|3040044|Superiority or Other|||||||0.0039||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652232|NCT01675427|3040044|Superiority or Other|||||||0.2935||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652233|NCT01675427|3040044|Superiority or Other|||||||0.5998||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652234|NCT01675427|3040044|Superiority or Other|||||||0.1027||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652235|NCT01675427|3040044|Superiority or Other|||||||0.0145||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652236|NCT01675427|3040044|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652237|NCT01675427|3040045|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652238|NCT01675427|3040045|Superiority or Other||||||<|0.8956||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652239|NCT01675427|3040045|Superiority or Other||||||<|0.1634||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652240|NCT01675427|3040045|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652241|NCT01675427|3040045|Superiority or Other||||||<|0.2887||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652242|NCT01675427|3040045|Superiority or Other||||||<|0.0001||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652243|NCT01675427|3040046|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Tests for association between the two variables|Chi-squared||||
1652244|NCT01675427|3040047|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Tests for association between the two variables|Chi-squared||||
1652245|NCT01675427|3040048|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Tests for association between the two variables|Chi-squared||||
1652246|NCT01675427|3040049|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Tests for association between the two variables|Chi-squared||||
1652247|NCT01675427|3040050|Superiority or Other|||||||0.0842||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test||||
1652248|NCT01675427|3040051|Superiority or Other|||||||0.7918||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test||||
1652249|NCT01675427|3040052|Superiority or Other|||||||0.0526||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test||||
1652250|NCT01675427|3040053|Superiority or Other|||||||0.2617||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test||||
1652251|NCT01675427|3040054|Superiority or Other|||||||0.0663||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test||||
1652252|NCT01675427|3040055|Superiority or Other|||||||0.1623||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test||||
1652253|NCT01675427|3040056|Superiority or Other|||||||0.002||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test||||
1652254|NCT01675427|3040057|Superiority or Other|||||||0.5468||||||Jonckheere-Terpstra Test for a trend of a continuous variable across the three IL28B genotype categories|Jonckheere-Terpstra Test||||
1652255|NCT01675427|3040058|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Tests for association between the two variables|Chi-squared||||
1652256|NCT01675427|3040059|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Tests for association between the two variables|Chi-squared||||
1652257|NCT01675427|3040060|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Tests for association between the two variables|Chi-squared||||
1652258|NCT01675427|3040061|Superiority or Other||||||<|0.0001||||||Pearson Chi-Square Tests for association between the two variables|Chi-squared||||
1652404|NCT01672970|3040375|Superiority or Other|||||||0|||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6|
1652259|NCT01675427|3040062|Superiority or Other|||||||0.4545||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test||||
1652260|NCT01675427|3040063|Superiority or Other|||||||0.042||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test||||
1652261|NCT01675427|3040064|Superiority or Other|||||||0.5651||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test||||
1652262|NCT01675427|3040065|Superiority or Other|||||||0.0049||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test||||
1652263|NCT01675427|3040066|Superiority or Other|||||||0.2887||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652264|NCT01675427|3040066|Superiority or Other|||||||0.2386||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652265|NCT01675427|3040066|Superiority or Other|||||||0.8364||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652266|NCT01675427|3040066|Superiority or Other|||||||0.4619||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652267|NCT01675427|3040066|Superiority or Other|||||||0.2671||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652268|NCT01675427|3040066|Superiority or Other|||||||0.2416||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652269|NCT01675427|3040067|Superiority or Other|||||||0.6119||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652270|NCT01675427|3040067|Superiority or Other|||||||0.4884||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652271|NCT01675427|3040067|Superiority or Other|||||||0.4247||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652272|NCT01675427|3040067|Superiority or Other|||||||0.2432||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652273|NCT01675427|3040067|Superiority or Other|||||||0.0763||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652274|NCT01675427|3040067|Superiority or Other|||||||0.8537||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652275|NCT01675427|3040068|Superiority or Other|||||||0.3921||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652276|NCT01675427|3040068|Superiority or Other|||||||0.2386||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652277|NCT01675427|3040068|Superiority or Other|||||||0.1351||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652278|NCT01675427|3040068|Superiority or Other|||||||0.7586||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652279|NCT01675427|3040068|Superiority or Other|||||||0.3419||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652280|NCT01675427|3040068|Superiority or Other|||||||0.5216||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652281|NCT01675427|3040069|Superiority or Other|||||||0.3069||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Total genotypes|
1652282|NCT01675427|3040069|Superiority or Other|||||||0.4795||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||Other genotypes|
1652283|NCT01675427|3040069|Superiority or Other|||||||0.0781||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G4|
1652284|NCT01675427|3040069|Superiority or Other|||||||0.092||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G3|
1652285|NCT01675427|3040069|Superiority or Other|||||||0.7055||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G2|
1652286|NCT01675427|3040069|Superiority or Other|||||||0.9859||||||Jonckheere-Terpstra Test for a trend of an ordinal variable across the three IL28B genotype categories|Jonckheere-Terpstra Test|||G1|
1652287|NCT01675427|3040070|Superiority or Other|||||||0.3295||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes|
1652288|NCT01675427|3040070|Superiority or Other|||||||0.1075||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes|
1652289|NCT01675427|3040070|Superiority or Other|||||||0.0403||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4|
1652290|NCT01675427|3040070|Superiority or Other|||||||0.7006||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3|
1652291|NCT01675427|3040070|Superiority or Other|||||||0.324||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2|
1652292|NCT01675427|3040070|Superiority or Other|||||||0.2693||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1|
1652405|NCT01672970|3040375|Superiority or Other|||||||0|||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3|
1652293|NCT01675427|3040071|Superiority or Other|||||||0.1681||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes|
1652294|NCT01675427|3040071|Superiority or Other|||||||0.5751||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes|
1652295|NCT01675427|3040071|Superiority or Other|||||||0.6258||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4|
1652296|NCT01675427|3040071|Superiority or Other|||||||0.138||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3|
1652297|NCT01675427|3040071|Superiority or Other|||||||0.7174||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2|
1652298|NCT01675427|3040071|Superiority or Other|||||||0.0126||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1|
1652299|NCT01675427|3040072|Superiority or Other|||||||0.3159||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes|
1652300|NCT01675427|3040072|Superiority or Other|||||||0.1781||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes|
1652301|NCT01675427|3040072|Superiority or Other|||||||0.3975||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4|
1652302|NCT01675427|3040072|Superiority or Other|||||||0.8597||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3|
1652303|NCT01675427|3040072|Superiority or Other|||||||0.44||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2|
1652304|NCT01675427|3040072|Superiority or Other|||||||0.4133||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1|
1652305|NCT01675427|3040073|Superiority or Other|||||||0.2702||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Total genotypes|
1652306|NCT01675427|3040073|Superiority or Other|||||||0.4828||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||Other genotypes|
1652307|NCT01675427|3040073|Superiority or Other|||||||0.4681||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G4|
1652308|NCT01675427|3040073|Superiority or Other|||||||0.1112||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G3|
1652309|NCT01675427|3040073|Superiority or Other|||||||0.2289||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G2|
1652310|NCT01675427|3040073|Superiority or Other|||||||0.0018||||||Cochran-Armitage Trend Test for a trend in binomial proportions across the three IL28B genotype categories|Cochran-Armitage Trend Test|||G1|
1652311|NCT01675167|3040084|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by Stratum (Dose Level)||Responders with ≥50% pain reduction|
1652312|NCT01675167|3040084|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥30% pain reduction|
1652313|NCT01675167|3040085|Superiority or Other||Mean Difference (Net)|-0.98|||<|1e-05|2-Sided|95.0|-1.32|-0.64||P value was adjusted using weighted z-test (CHW).|ANCOVA||||
1652314|NCT01674725|3040111|Non-Inferiority or Equivalence|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% confidence interval for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.|Percentage of Participants|2.3|||||2-Sided|95.0|-0.8|5.4|||||95% CI was calculated using the normal approximation to the binomial distribution.||
1652315|NCT01674725|3040111|Superiority or Other||Percentage of Participants|100.0|||||2-Sided|95.0|95.9|100.0|||||95% CI was calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority||
1652316|NCT01674725|3040111|Superiority or Other||Percentage of Participants|97.7|||||2-Sided|95.0|94.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.||
1652317|NCT01674725|3040112|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1652318|NCT01674725|3040113|Non-Inferiority or Equivalence|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.|Percentage of Participants|97.7|||||2-Sided|95.0|94.6|100.0|||||95% CI was calculated using the normal approximation to the binomial distribution.|Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have >90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.|
1652339|NCT01674621|3040158|Superiority or Other (legacy)||Mean Difference (Final Values)|-62.872|||||2-Sided|95.0|-86.019|-39.725|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).||
1652340|NCT01674621|3040158|Superiority or Other (legacy)||Mean Difference (Final Values)|-73.906|||||2-Sided|95.0|-96.926|-50.886|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).||
1652319|NCT01674725|3040113|Non-Inferiority or Equivalence|The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.|Percentage of Participants|100.0|||||2-Sided|95.0|95.9|100.0|||||95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%.|Planned enrollment is 210 to allow ≥200 GT1b-infected participants to be treated with combination formulation of ABT-450/r/ABT-267 and ABT-333 with and without RBV. Enrollment terminated after 187 participants were randomized. Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have >90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.|
1652320|NCT01674647|3040130|Superiority or Other||Risk Ratio (RR)|0.84|||||2-Sided|95.0|0.2|3.49|||||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.51% (0.20% - 1.17%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.61% (0.17% - 1.72%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals|
1652321|NCT01674647|3040131|Superiority or Other||Risk Ratio (RR)|1.01|||||2-Sided|95.0|0.18|5.47|||||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.41% (0.14% - 1.02%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.41% (0.07% - 1.41%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals|
1652322|NCT01674647|3040136|Superiority or Other||Risk Ratio (RR)|0.5|||||2-Sided|95.0|0.16|1.55|||||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.61% (0.27% - 1.29%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 1.22% (0.53% - 2.51%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals|
1652323|NCT01674647|3040137|Superiority or Other||Risk Ratio (RR)|0.34|||||2-Sided|95.0|0.06|2.0|||||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.20% (0.04% - 0.71%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.61% (0.17% - 1.72%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals|
1652324|NCT01674647|3040138|Superiority or Other||Risk Ratio (RR)|0.76|||||2-Sided|95.0|0.21|2.67|||||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.61% (0.26% - 1.27%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 0.80% (0.27% - 2.00%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals|
1652325|NCT01674647|3040139|Superiority or Other||Risk Ratio (RR)|0.5|||||2-Sided|95.0|0.15|1.73|||||Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.51% (0.20% - 1.17%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 1.02% (0.40% - 2.34%).|Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals|
1652326|NCT01674621|3040156|Superiority or Other (legacy)||Mean Difference (Final Values)|-49.334|||||2-Sided|95.0|-82.113|-16.555|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).||
1652327|NCT01674621|3040156|Superiority or Other (legacy)||Mean Difference (Final Values)|-39.461|||||2-Sided|95.0|-71.665|-7.257|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).||
1652328|NCT01674621|3040156|Superiority or Other (legacy)||Mean Difference (Final Values)|-43.721|||||2-Sided|95.0|-75.748|-11.694|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).||
1652329|NCT01674621|3040156|Superiority or Other (legacy)|||||||0.1067||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652330|NCT01674621|3040156|Superiority or Other (legacy)|||||||0.6839||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652331|NCT01674621|3040156|Superiority or Other (legacy)|||||||0.3483||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of CTXI from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652332|NCT01674621|3040157|Superiority or Other (legacy)||Mean Difference (Final Values)|-104.418|||||2-Sided|95.0|-152.079|-56.758|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).||
1652333|NCT01674621|3040157|Superiority or Other (legacy)||Mean Difference (Final Values)|-96.115|||||2-Sided|95.0|-142.94|-49.29|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).||
1652334|NCT01674621|3040157|Superiority or Other (legacy)||Mean Difference (Final Values)|-110.398|||||2-Sided|95.0|-156.966|-63.831|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).||
1652335|NCT01674621|3040157|Superiority or Other (legacy)|||||||0.9999||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to EOT to each transdermal dose group versus placebo.|||
1652336|NCT01674621|3040157|Superiority or Other (legacy)|||||||0.6091||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652337|NCT01674621|3040157|Superiority or Other (legacy)|||||||0.8569||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PINP from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652338|NCT01674621|3040158|Superiority or Other (legacy)||Mean Difference (Final Values)|-73.367|||||2-Sided|95.0|-96.927|-49.807|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).||
1652341|NCT01674621|3040158|Superiority or Other (legacy)|||||||0.9998||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.|||
1652342|NCT01674621|3040158|Superiority or Other (legacy)|||||||0.12||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.|||
1652343|NCT01674621|3040158|Superiority or Other (legacy)|||||||1||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of serum osteocalcin from baseline to EOT to each transdermal dose group versus placebo.|||
1652344|NCT01674621|3040159|Superiority or Other (legacy)||Mean Difference (Final Values)|-26.914|||||2-Sided|95.0|-48.424|-5.405|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).||
1652345|NCT01674621|3040159|Superiority or Other (legacy)||Mean Difference (Final Values)|-18.702|||||2-Sided|95.0|-39.835|2.43|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).||
1652346|NCT01674621|3040159|Superiority or Other (legacy)||Mean Difference (Final Values)|-27.541|||||2-Sided|95.0|-48.557|-6.525|||||Mean difference of percent change from baseline to end of treatment between the active treatment groups (transdermal and SC injection).||
1652347|NCT01674621|3040159|Superiority or Other (legacy)|||||||0.2179||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment (EOT) to each transdermal dose group versus placebo.|||
1652348|NCT01674621|3040159|Superiority or Other (legacy)|||||||0.9834||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652349|NCT01674621|3040159|Superiority or Other (legacy)|||||||0.1632||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of PICP from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652350|NCT01674621|3040160|Superiority or Other (legacy)||Mean Difference (Final Values)|-22.828|||||2-Sided|95.0|-41.614|-4.041|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).||
1652351|NCT01674621|3040160|Superiority or Other (legacy)||Mean Difference (Final Values)|-12.086|||||2-Sided|95.0|-30.543|6.372|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).||
1652352|NCT01674621|3040160|Superiority or Other (legacy)||Mean Difference (Final Values)|-22.146|||||2-Sided|95.0|-40.501|-3.79|||||Mean difference of percent change from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).||
1652353|NCT01674621|3040160|Superiority or Other (legacy)|||||||0.239||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652354|NCT01674621|3040160|Superiority or Other (legacy)|||||||0.9115||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652355|NCT01674621|3040160|Superiority or Other (legacy)|||||||0.2549||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BSAP from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652356|NCT01674621|3040161|Superiority or Other (legacy)||Mean Difference (Final Values)|0.517|||||2-Sided|95.0|-1.106|2.139|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).||
1652357|NCT01674621|3040161|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.483|||||2-Sided|95.0|-2.115|1.15|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).||
1652358|NCT01674621|3040161|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.564|||||2-Sided|95.0|-2.168|1.04|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).||
1652359|NCT01674621|3040161|Superiority or Other (legacy)|||||||0.5191||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.|||
1652360|NCT01674621|3040161|Superiority or Other (legacy)|||||||0.9806||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.|||
1652361|NCT01674621|3040161|Superiority or Other (legacy)|||||||0.9493||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of treatment to each transdermal dose group versus placebo.|||
1652362|NCT01674621|3040162|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.247|||||2-Sided|95.0|-2.368|-0.126|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).||
1652363|NCT01674621|3040162|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.42|||||2-Sided|95.0|-2.522|-0.318|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).||
1652364|NCT01674621|3040162|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.768|||||2-Sided|95.0|-2.864|-0.672|||||Mean difference of percent change off BMD from baseline to end-of-treatment between active treatment groups (transdermal and SC injection).||
1652365|NCT01674621|3040162|Superiority or Other (legacy)|||||||0.0018||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652366|NCT01674621|3040162|Superiority or Other (legacy)|||||||0.0056||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652397|NCT01672970|3040367|Superiority or Other|||||||0|||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3|
1652367|NCT01674621|3040162|Superiority or Other (legacy)|||||||0.0547||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652368|NCT01674621|3040163|Superiority or Other (legacy)||Mean Difference (Final Values)|-2.856|||||2-Sided|95.0|-4.519|-1.193|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).||
1652369|NCT01674621|3040163|Superiority or Other (legacy)||Mean Difference (Final Values)|-3.47|||||2-Sided|95.0|-5.104|-1.837|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).||
1652370|NCT01674621|3040163|Superiority or Other (legacy)||Mean Difference (Final Values)|-3.93|||||2-Sided|95.0|-5.555|-2.305|||||Mean difference of percent change of BMD from baseline to end-of-treatment between treatment groups (transdermal and SC injection).||
1652371|NCT01674621|3040163|Superiority or Other (legacy)||||||<|0.0001||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652372|NCT01674621|3040163|Superiority or Other (legacy)||||||<|0.0005||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652373|NCT01674621|3040163|Superiority or Other (legacy)||||||<|0.0066||||||Threshold for significance at 0.05 level.|Dunnett's test|P-value from Dunnett's test comparing percent change of BMD from baseline to end-of-treatment to each transdermal dose group versus placebo.|||
1652374|NCT01673867|3040211|Superiority or Other (legacy)||Odds Ratio (OR)|1.51|||||2-Sided|95.0|0.43|5.63|||||Odds Ratio (95% CI) Nivolumab 3mg/kg over Docetaxel : PD-L1 expression not quantifiable at baseline|PD-L1 expression not quantifiable at baseline|
1652375|NCT01673867|3040211|Superiority or Other (legacy)||Odds Ratio (OR)|0.59|||||2-Sided|95.0|0.22|1.48|||||Odds Ratio (95% CI) Nivolumab 3mg/kg over Docetaxel : PD-L1 expression < 1%|PD-L1 expression < 1%|
1652376|NCT01673867|3040211|Superiority or Other (legacy)||Odds Ratio (OR)|3.22|||||2-Sided|95.0|1.6|6.71|||||Odds Ratio (95% CI) Nivolumab 3mg/kg over Docetaxel : PD-L1 expression >= 1%|PD-L1 expression >= 1%|
1652377|NCT01673867|3040213|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91|||||2-Sided|95.0|0.61|1.35|||||Hazard Ratio (95% CI) : Nivolumab 3mg/kg over Docetaxel : PD-L1 expression not quantifiable at baseline|PD-L1 expression not quantifiable at baseline|
1652378|NCT01673867|3040213|Superiority or Other (legacy)||Hazard Ratio (HR)|0.9|||||2-Sided|95.0|0.66|1.24|||||Hazard Ratio (95% CI) Nivolumab 3mg/kg over Docetaxel: PD-L1 expression < 1%|PD-L1 expression < 1%|
1652379|NCT01673867|3040213|Superiority or Other (legacy)||Hazard Ratio (HR)|0.59|||||2-Sided|95.0|0.43|0.82|||||Hazard Ratio (95% CI) Nivolumab 3mg/kg over Docetaxel : PD-L1 expression >= 1%|PD-L1 expression >= 1%|
1652380|NCT01673867|3040216|Superiority or Other (legacy)||Hazard Ratio (HR)|0.92||||0.3932|2-Sided|95.0|0.77|1.11|||Log Rank||HR = Nivolumab over docetaxel||
1652381|NCT01673867|3040220|Superiority or Other (legacy)||Odds Ratio (OR)|1.68||||0.0246|2-Sided|95.0|1.07|2.64|||Cochran-Mantel-Haenszel||Odds Ratio = Nivolumab over docetaxel||
1652382|NCT01673867|3040221|Superiority or Other (legacy)||Hazard Ratio (HR)|0.73||||0.0015|2-Sided|95.92|0.59|0.89|||Log Rank||HR = Nivolumab over docetaxel||
1652383|NCT01673698|3040229|Superiority or Other|||||||0.561|||||||Chi-squared||||
1652384|NCT01673698|3040230|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided||||
1652385|NCT01673698|3040231|Superiority or Other|||||||0.0041|||||||t-test, 1 sided||||
1652386|NCT01673490|3040256|Superiority or Other||||||<|0.001||||||for Month 6|t-test, 2 sided||||
1652387|NCT01673490|3040256|Superiority or Other||||||<|0.001||||||for Month 3|t-test, 2 sided||||
1652388|NCT01673490|3040257|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1652389|NCT01673373|3040279|Other|A one-sided 95% Confidence Interval for the mean difference between baseline and 9-month systolic blood pressure was constructed and the lower limit compared to the 10 mmHg performance goal. A p-value of the difference between the estimated systolic blood pressure change from the baseline and the performance goal was computed using a paired t-test.||||||0.0192||||||The defined threshold for statistical significance is .025.|t-test, 1 sided|||The primary endpoint of systolic blood pressure was analyzed according to the Performance Goal of a decrease in systolic blood pressure of 10 mmHg between procedure and 9 months.|
1652390|NCT01673373|3040280|Other|Due to the early termination of enrollment, all inferential analyses were interpreted as descriptive and carried out in an exploratory manner.|||||<|0.0001||||||The p-value was computed using a one-sided exact test of the difference between the observed rate and the Performance Goal (equal to 70%). The defined threshold for statistical significance is .025.|one-sided exact|||The original Performance Goal of 70% patency rate was derived from a thorough literature review of trials with renal bare metal stent placement. Other assumptions included a determination of samples size based upon a one-sided alpha of 0.025 and desired power of 87%, and assumption of 10% attrition. The null hypothesis was that the incidence of primary patency at 9 months is less than or equal to 70%.|"The cumulative incidence of primary patency was computed as the number of subject-lesions with primary patency at 9 months divided by the number of subject-lesions and was analyzed using the allowable window of 243 to 303 trial days.~An exact binomial one-sided 95% CI was constructed and the lower limit compared to the Performance Goal equal to 70%."
1652391|NCT01673282|3040285|Superiority or Other||Least Square Mean|-0.24|Standard Error of the Mean|0.06|=|0|2-Sided|95.0|-0.36|-0.11|||ANCOVA|||Based on an ANCOVA model for absolute change in ratio of dose and DDD with group as a fixed effect and the ratio of dose and DDD at Baseline as a covariate.|
1652392|NCT01672970|3040365|Superiority or Other|||||||0|||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6|
1652393|NCT01672970|3040365|Superiority or Other|||||||0|||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3|
1652394|NCT01672970|3040366|Superiority or Other|||||||0|||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6|
1652395|NCT01672970|3040366|Superiority or Other|||||||0|||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3|
1652396|NCT01672970|3040367|Superiority or Other|||||||0|||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6|
1652406|NCT01672970|3040376|Superiority or Other|||||||0|||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 6|
1652407|NCT01672970|3040376|Superiority or Other|||||||0|||||||Wilcoxon Signed Ranks Test|||Statistical Analysis at Month 3|
1652408|NCT01672970|3040379|Superiority or Other|||||||0.001|||||||Wilcoxon Signed Rank Test||||
1652409|NCT01672970|3040379|Superiority or Other|||||||0|||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3|
1652410|NCT01672970|3040380|Superiority or Other|||||||0|||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6|
1652411|NCT01672970|3040380|Superiority or Other|||||||0|||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3|
1652412|NCT01672970|3040381|Superiority or Other|||||||0.005|||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6|
1652413|NCT01672970|3040381|Superiority or Other|||||||0.001|||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 3|
1652414|NCT01672970|3040382|Superiority or Other|||||||0|||||||Wilcoxon Signed Rank Test|||Statistical Analysis at Month 6|
1652415|NCT01672970|3040382|Superiority or Other|||||||0|||||||Wilcoxon Signed Rank Test|||Statistical analysis at Month 3|
1652416|NCT01672892|3040408|Other||||||<|0.0001|||||||Paired t-test|||Urinary domain|
1652417|NCT01672892|3040408|Other||||||<|0.0001|||||||Paired t-test|||Bowel domain|
1652418|NCT01672892|3040409|Other||||||<|0.0001|||||||One-sample t-test|||Urinary domain at week 5|
1652419|NCT01672892|3040409|Other||||||<|0.0001|||||||One-sample t-test|||Urinary domain at baseline|
1652420|NCT01672892|3040409|Other||||||<|0.0001|||||||One-sample t-test|||Bowel domain at week 5|
1652421|NCT01672892|3040409|Other||||||<|0.0001|||||||One-sample t-test|||Bowel domain at baseline|
1652422|NCT01672892|3040410|Other||||||<|0.0001|||||||nonparametric one-sample t-test|||Week 5|
1652423|NCT01672892|3040410|Other||||||<|0.0001|||||||nonparametric one-sample t-test|||Baseline|
1652424|NCT01672892|3040413|Superiority||Hazard Ratio (HR)|0.76||||0.53|2-Sided|95.0|0.32|1.79|||Log Rank|Two-sided significance level = 0.05|Reference level = Intensity-Modulated Radiation Therapy||
1652425|NCT01672892|3040414|Superiority||Hazard Ratio (HR)|1.39||||0.21|2-Sided|95.0|0.82|2.35|||Log Rank|Two-side significance level = 0.05|Reference level = Intensity-Modulated Radiation Therapy||
1652426|NCT01672892|3040415|Superiority|||||||0.81|||||||Gray's test|Two-sided significance level = 0.05|||
1652427|NCT01672892|3040416|Superiority|||||||0.67|||||||t-test, 2 sided|2-sided significance level = 0.05||4-6 weeks post-RT|
1652428|NCT01672892|3040416|Superiority|||||||0.61|||||||t-test, 2 sided|2-sided significance level = 0.05||5 weeks|
1652429|NCT01672892|3040417|Superiority|||||||0.35|||||||t-test, 2 sided|2-sided significance level = 0.0125||Social subscale score - 4-6 weeks post RT|
1652430|NCT01672892|3040417|Superiority|||||||0.66|||||||t-test, 2 sided|2-sided significance level = 0.0125||Social subscale score - 5 weeks|
1652431|NCT01672892|3040417|Superiority|||||||0.09|||||||t-test, 2 sided|2-sided significance level = 0.0125||Emotional subscale score - 4-6 weeks post RT|
1652432|NCT01672892|3040417|Superiority|||||||0.66|||||||t-test, 2 sided|2-sided significance level = 0.0125||Emotional subscale score - 5 weeks|
1652433|NCT01672892|3040417|Superiority|||||||0.35|||||||t-test, 2 sided|2-sided significance level = 0.0125||Functional subscale score - 4-6 weeks post RT|
1652434|NCT01672892|3040417|Superiority|||||||0.55|||||||t-test, 2 sided|2-sided significance level = 0.0125||Functional subscale score - 5 weeks|
1652435|NCT01672892|3040417|Superiority|||||||0.9|||||||t-test, 2 sided|2-sided significance level = 0.0125||Physical subscale score - 4-6 weeks post RT|
1652436|NCT01672892|3040417|Superiority|||||||0.03|||||||t-test, 2 sided|2-sided significance level = 0.0125||Physical subscale score - 5 weeks|
1652437|NCT01672892|3040417|Superiority|||||||0.45|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-Cx subscale score - 4-6 weeks post RT|
1652438|NCT01672892|3040417|Superiority|||||||0.01|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-Cx subscale score - 5 weeks|
1652439|NCT01672892|3040417|Superiority|||||||0.72|||||||t-test, 2 sided|FACT-G total score - 4-6 weeks post RT||FACT-G total score - 4-6 weeks post RT|
1652440|NCT01672892|3040417|Superiority|||||||0.54|||||||t-test, 2 sided|2-sided significance level = 0.05||FACT-G total score - 5 weeks|
1652441|NCT01672892|3040418|Superiority|||||||0.41|||||||t-test, 2 sided|2-sided significance level of 0.05||4-6 weeks post-RT|
1652442|NCT01672892|3040418|Superiority|||||||0.03|||||||t-test, 2 sided|2-sided significance level of 0.05||Week 5 of RT|
1652443|NCT01672892|3040418|Superiority|||||||0.04|||||||t-test, 2 sided|2-sided significance level of 0.05||Week 3 of RT|
1652444|NCT01672892|3040419|Superiority|||||||0.4338|||||||Binomial test of proportions|2-sided significance level = 0.05|||
1652445|NCT01672892|3040420|Superiority|||||||0.0476|||||||t-test, 1 sided|||Since there is no prior data using this tool in this patient population, an effect size of 0.4 was chosen to calculate sample size. Based on a two-sample t-test with one interim look and a two-sided alpha=0.05, a sample size of 225 is needed to achieve 85% statistical power. Assuming an attrition rate of 10% and noncompliance of 10%, 281 patients were required in order to ensure 225 evaluable patients for the primary endpoint analysis.|
1652446|NCT01672879|3040421|Superiority|||||||0.065|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (< 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.|
1652447|NCT01672879|3040421|Superiority|||||||0.41|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by HVPG category (< 10 mmHg vs ≥ 10 mmHg) and presence or absence of diabetes at baseline.|
1652448|NCT01672879|3040422|Superiority||Difference in LSMeans [SIM - Placebo]|0.1|||||2-Sided|95.0|-1.2|1.4||||||An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.|
1652449|NCT01672879|3040422|Superiority||Difference in LSMeans [SIM - Placebo]|0.1|||||2-Sided|95.0|-1.2|1.5||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in HVPG at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in HVPG at Week 96 contributed to the overall model.|
1652450|NCT01672866|3040423|Superiority|||||||0.85|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.|
1652451|NCT01672866|3040423|Superiority|||||||0.73|||||||Stratified log-rank test|||Differences in EFS between a given SIM group and placebo were assessed using the log-rank test stratified by the presence or absence of diabetes at baseline.|
1652452|NCT01672866|3040424|Superiority||Difference in LSMeans [SIM - Placebo]|-0.4|||||2-Sided|95.0|-1.5|0.8||||||An MMRM with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.|
1652453|NCT01672866|3040424|Superiority||Difference in LSMeans [SIM - Placebo]|-0.2|||||2-Sided|95.0|-1.3|1.0||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.|
1652454|NCT01672853|3040428|Superiority||Difference in LS Mean|1.0|||||2-Sided|95.0|-1.0|3.0||||||A MMRM with an unstructured variancecovariance matrix for each participant was used to calculate a point estimate and a 95% CI for the treatment difference between each treatment arm and placebo in LSMean change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.|
1652455|NCT01672853|3040428|Superiority||Difference in LS Mean|-0.4|||||2-Sided|95.0|-2.3|1.6||||||A mixed-effect model for repeated measures (MMRM) with an unstructured variance-covariance matrix for each participant was used to calculate a point estimate and a 95% confidence interval (CI) for the treatment difference between each treatment arm and placebo in least squares mean (LSMean) change from baseline in MQC at Week 96. With MMRM setting, all participants with available data from the 3 treatment groups with change in MQC at Week 48 and/or Week 96 contributed to the overall model.|
1652456|NCT01672788|3040432|Non-Inferiority or Equivalence|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose .|Geometric Mean Ratio|98.57|Standard Deviation|10.1|||2-Sided|90.0|94.5|102.81|||||Standard deviation is actually the gCV||
1652457|NCT01672788|3040432|Non-Inferiority or Equivalence|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose .|Geometric Mean Ratio|101.51|Standard Deviation|8.6|||2-Sided|90.0|97.95|105.21|||||Standard deviation is actually the geometric coefficient of variation (gCV)||
1652458|NCT01672788|3040433|Non-Inferiority or Equivalence|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose.|Geometric Mean Ratio|97.89|Standard Deviation|10.2|||2-Sided|90.0|93.82|102.15|||||Standard deviation is actually the gCV||
1652459|NCT01672788|3040433|Non-Inferiority or Equivalence|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose .|Geometric Mean Ratio|99.64|Standard Deviation|10.5|||2-Sided|90.0|95.39|104.09|||||Standard deviation is actually the geometric coefficient of variation (gCV)||
1652460|NCT01672788|3040434|Non-Inferiority or Equivalence|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.97|Standard Deviation|12.3|||2-Sided|90.0|95.94|106.27|||||Standard deviation is actually the gCV||
1652461|NCT01672788|3040434|Non-Inferiority or Equivalence|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|102.7|Standard Deviation|9.4|||2-Sided|90.0|98.75|106.81|||||Standard deviation is actually the geometric coefficient of variation (gCV)||
1652462|NCT01672788|3040435|Non-Inferiority or Equivalence|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.31|Standard Deviation|7.0|||2-Sided|90.0|97.41|103.3|||||Standard deviation is actually the gCV||
1652463|NCT01672788|3040435|Non-Inferiority or Equivalence|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|101.2|Standard Deviation|10.4|||2-Sided|90.0|96.89|105.71|||||Standard deviation is actually the geometric coefficient of variation (gCV)||
1652464|NCT01672788|3040436|Non-Inferiority or Equivalence|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose.|Geometric Mean Ratio|98.56|Standard Deviation|10.8|||2-Sided|90.0|94.24|103.08|||||Standard deviation is actually the gCV||
1652465|NCT01672788|3040436|Non-Inferiority or Equivalence|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose.|Geometric Mean Ratio|101.61|Standard Deviation|8.8|||2-Sided|90.0|97.94|105.41|||||Standard deviation is actually the gCV||
1652466|NCT01672788|3040437|Non-Inferiority or Equivalence|Considered characteristic is empa 5mg fixed-dose divided by empa 5mg free dose|Geometric Mean Ratio|100.3|Standard Deviation|7.0|||2-Sided|90.0|97.4|103.29|||||Standard deviation is actually the geometric coefficient of variation (gCV)||
1652467|NCT01672788|3040437|Non-Inferiority or Equivalence|Considered characteristic is empa 12.5mg fixed-dose divided by empa 12.5mg free dose|Geometric Mean Ratio|101.31|Standard Deviation|10.7|||2-Sided|90.0|96.89|105.93|||||Standard deviation is actually the geometric coefficient of variation (gCV)||
1652468|NCT01672710|3040443|Superiority||Mean Difference (Net)|6.9|||<|0.05|2-Sided|95.0|-0.3|14.2|||ANCOVA||||
1652469|NCT01672294|3040454|Superiority or Other||Mean Difference (Final Values)|-0.1154||||0.3249|2-Sided|95.0|-0.3466|0.1158||Between Caregiver Outlook – Caregiver and Relaxation Meditation - Caregiver at 8 weeks|Mixed Models Analysis|||Comparison at 8 week time point Note- Missing first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 week.|
1652579|NCT01668966|3040757|Superiority or Other|||||||0.8687|||||||Paired t-test|||Statistical analysis at Week 104|
1652470|NCT01672294|3040454|Superiority or Other||Mean Difference (Final Values)|-0.01166||||0.9221|2-Sided|95.0|-0.2475|0.2241|||Mixed Models Analysis|||At 5 weeks - Completion subscale|
1652471|NCT01672294|3040455|Superiority or Other||Mean Difference (Final Values)|-0.00087||||0.9863|2-Sided|95.0|-0.1003|0.09861||Between Caregiver Outlook – Caregiver and Relaxation Meditation - Caregiver at 8 weeks|Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.|
1652472|NCT01672294|3040455|Superiority or Other||Mean Difference (Final Values)|-0.01777||||0.7687|2-Sided|95.0|-0.1372|0.1017||Between Caregiver Outlook – Caregiver and Relaxation Meditation - Caregiver at 5 weeks|Mixed Models Analysis|||"Between Outlook Intervention caregivers and active control caregivers at 5 weeks.~Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks."|
1652473|NCT01672294|3040456|Superiority or Other||expected change in difference in logs|0.0593||||0.8748|2-Sided|95.0|-0.6784|0.797|||Standard negative binomial with offset||The expected change in the difference of the logs of expected Days in VA inpatient care or ED.||
1652474|NCT01672294|3040457|Superiority or Other||Mean Difference (Final Values)|0.6929||||0.3842|2-Sided|95.0|-0.8783|2.2642||Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks|Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 8 weeks Note - Missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks|
1652475|NCT01672294|3040457|Superiority or Other||Mean Difference (Final Values)|0.9358|||<|0.3332|2-Sided|95.0|-0.9726|2.8443|||Mixed Models Analysis|||Between Outlook Intervention caregivers and active control caregivers at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.|
1652476|NCT01672294|3040458|Superiority or Other||Mean Difference (Final Values)|1.2764||||0.1972|2-Sided|95.0|-0.6728|3.2257|||Mixed Models Analysis|||Comparison at 8 weeks. Note-missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.|
1652477|NCT01672294|3040458|Superiority or Other||Mean Difference (Final Values)|0.6836||||0.5225|2-Sided|95.0|-1.4278|2.795|||Mixed Models Analysis|||Comparison at 5 weeks Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.|
1652478|NCT01672294|3040459|Superiority or Other||Mean Difference (Final Values)|0.4275||||0.6348|2-Sided|95.0|-1.3505|2.2055||Between Outlook Intervention and Attention Control caregivers at 8 weeks|Mixed Models Analysis|||Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.|
1652479|NCT01672294|3040459|Superiority or Other||Mean Difference (Final Values)|0.5376|||<|0.511|2-Sided|95.0|-1.0776|2.1528||Between Outlook Intervention and Attention Control caregivers at 5 weeks|Mixed Models Analysis|||Note- missing the first follow up at 5 weeks did not prohibit an individual from participating at the second follow up at 8 weeks.|
1652480|NCT01671748|3040468|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.618|2-Sided|95.0|-4.7|2.9|||ANCOVA|Patients’ baseline (week 5) wound area was used as the covariate.|||
1652481|NCT01671748|3040470|Superiority or Other|||||||0.346|||||||Wilcoxon (Mann-Whitney)|||Change in number of infections were not normally distributed and differences between the arms were tested using the non-parametric Mann-Whitney U test.|
1652482|NCT01671748|3040471|Superiority or Other||Mean Difference (Net)|-9.08||||0.078|2-Sided|95.0|-19.23|1.06|||ANCOVA|||ANCOVA was used for change in pain score (VAS) from week 5 to week 13 (covariate was baseline pain score).|
1652483|NCT01671748|3040472|Superiority or Other|||||||0.49|||||||ANCOVA|||ANCOVA was used for change in HRQoL from week 1 to week 13 (with week 1 HRQoL score as the covariate).|
1652484|NCT01671748|3040473|Superiority or Other||Mean Difference (Final Values)|-7.4||||0.565|2-Sided|95.0|-33.4|18.6||ANCOVA was used to analyse differences between the NLFU+SOC and SOC arms of the primary endpoint, percentage change in wound area from baseline (week 5) to final visit (week 13). Patients’ baseline (week 5) wound area was used as the covariate.|ANCOVA|||The study was powered to detect a difference in the change in wound area of 20% between the two arms with a two sided significance level and power of 90%. A standard deviation of 17.5% came from published literature. A minimum of 17 patients in each arm was required.|
1652485|NCT01671111|3040504|Superiority or Other|||||||0.1248||||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test||||
1652486|NCT01671111|3040505|Superiority or Other|||||||0.2297||||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test||||
1652487|NCT01671111|3040506|Superiority or Other|||||||0.8061||||||P-value was from paired t-test for log-transformed data at post treatment timepoint versus baseline.|paired t-test||||
1652488|NCT01671111|3040507|Superiority or Other|||||||0.1319||||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test||||
1652489|NCT01671111|3040508|Superiority or Other|||||||0.1232||||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test||||
1652490|NCT01671111|3040509|Superiority or Other|||||||0.056||||||P-value was from paired t-test for post treatment timepoint versus baseline.|paired t-test||||
1652491|NCT01671085|3040510|Superiority or Other||Mean Difference (Net)|-45.11|||<|0.001|2-Sided|90.0|-65.91|-24.31||P-value is for Day 57.|Mixed Effects Models Analysis||||
1652492|NCT01671085|3040510|Superiority or Other||Mean Difference (Net)|-50.49|||<|0.001|2-Sided|90.0|-71.27|-29.7||P-value is for Day 43.|Mixed Effects Model Analysis||||
1652493|NCT01670656|3040570|Superiority or Other||Difference in Least Squares Means|-0.3|||=|0|2-Sided|95.0|-0.7|0.2|||cLDA||||
1652494|NCT01670656|3040570|Superiority or Other||Difference in Least Squares Means|-0.6|||=|0|2-Sided|95.0|-1.0|-0.1|||cLDA||||
1652495|NCT01670656|3040570|Superiority or Other||Difference in Least Squares Means|-0.6|||=|0|2-Sided|95.0|-1.0|-0.1|||cLDA||||
1652496|NCT01670656|3040570|Superiority or Other||Difference in Least Squares Means|-0.1|||=|0|2-Sided|95.0|-0.6|0.3|||cLDA||||
1652497|NCT01670656|3040571|Superiority or Other||Diffference in Least Squares Means|-1.2|||=|0|2-Sided|95.0|-3.0|0.6|||cLDA||||
1652498|NCT01670656|3040571|Superiority or Other||Difference in Least Squares Means|-2.3|||=|0|2-Sided|95.0|-4.1|-0.5|||cLDA||||
1652499|NCT01670656|3040571|Superiority or Other||Difference in Least Squares Means|-1.5|||=|0|2-Sided|95.0|-3.3|0.2|||cLDA||||
1652500|NCT01670656|3040571|Superiority or Other||Difference in Least Squares Means|-1.6|||=|0|2-Sided|95.0|-3.4|0.2|||cLDA||||
1652501|NCT01670656|3040572|Superiority or Other||Difference in Least Squares Means|-1.2|||=|0|2-Sided|95.0|-2.5|0.1|||cLDA||||
1652502|NCT01670656|3040572|Superiority or Other||Difference in Least Squares Means|-1.6|||=|0|2-Sided|95.0|-2.9|-0.3|||cLDA||||
1652503|NCT01670656|3040572|Superiority or Other||Difference in Least Squares Means|-1.9|||<|0.001|2-Sided|95.0|-3.1|-0.6|||cLDA||||
1652504|NCT01670656|3040572|Superiority or Other||Difference in Least Squares Means|-1.7|||=|0|2-Sided|95.0|-3.0|-0.4|||cLDA||||
1652505|NCT01670656|3040573|Superiority or Other||Difference in Least Squares Means|-0.5|||<|0.001|2-Sided|95.0|-0.9|-0.2|||cLDA||||
1652506|NCT01670656|3040573|Superiority or Other||Difference in Least Squares Means|-0.8|||<|0.001|2-Sided|95.0|-1.1|-0.4|||cLDA||||
1652507|NCT01670656|3040573|Superiority or Other||Difference in Least Squares Means|-0.6|||<|0.001|2-Sided|95.0|-0.9|-0.2|||cLDA||||
1652508|NCT01670656|3040573|Superiority or Other||Difference in Least Squares Means|-0.6|||<|0.001|2-Sided|95.0|-1.0|-0.2|||cLDA||||
1652509|NCT01670188|3040602|Superiority|||||||0.02|||||||t-test, 2 sided||||
1652510|NCT01670110|3040603|Superiority|||||||0.51|||||||t-test, 2 sided|||Mental health|
1652511|NCT01670110|3040603|Superiority|||||||0.43|||||||t-test, 2 sided|||Role emotional|
1652512|NCT01670110|3040603|Superiority|||||||0.66|||||||t-test, 2 sided|||Social functioning|
1652513|NCT01670110|3040603|Superiority|||||||0.28|||||||t-test, 2 sided|||Vitality|
1652514|NCT01670110|3040603|Superiority|||||||0.18|||||||t-test, 2 sided|||General health|
1652515|NCT01670110|3040603|Superiority|||||||0.89|||||||t-test, 2 sided|||Bodily pain|
1652516|NCT01670110|3040603|Superiority|||||||0.48|||||||t-test, 2 sided|||Physical role|
1652517|NCT01670110|3040603|Superiority|||||||0.31|||||||t-test, 2 sided|||Physical functioning|
1652518|NCT01670110|3040604|Superiority|||||||0.73|||||||t-test, 2 sided||||
1652519|NCT01670110|3040605|Superiority|||||||0.001|||||||t-test, 2 sided||||
1652520|NCT01670110|3040606|Superiority|||||||0.001|||||||t-test, 2 sided||||
1652521|NCT01670110|3040607|Superiority|||||||0.79|||||||t-test, 2 sided||||
1652522|NCT01670110|3040608|Superiority|||||||0.79|||||||t-test, 2 sided||||
1652523|NCT01670110|3040609|Superiority|||||||0.003|||||||ANCOVA||||
1652524|NCT01670110|3040610|Superiority|||||||0.001|||||||ANCOVA||||
1652525|NCT01669902|3040631|Superiority or Other|||||||0.0357|||||||Wilcoxon signed rank test|||Change at Month 6|
1652526|NCT01669902|3040631|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed rank test|||Change at Month 3|
1652527|NCT01669811|3040656|Superiority or Other||Hazard Ratio (HR)|1.38||||0.4485|2-Sided|95.0|0.8|2.38|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd|
1652528|NCT01669811|3040657|Superiority or Other||Hazard Ratio (HR)|1.15||||0.6389|2-Sided|95.0|0.62|2.12|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd|
1652529|NCT01669811|3040658|Superiority or Other||Hazard Ratio (HR)|1.34||||0.2678|2-Sided|95.0|0.8|2.26|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd|
1652530|NCT01669811|3040659|Superiority or Other||Hazard Ratio (HR)|1.46||||0.0837|2-Sided|95.0|0.97|2.18|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd|
1652531|NCT01669811|3040660|Superiority or Other||Hazard Ratio (HR)|1.29||||0.1452|2-Sided|95.0|0.91|1.83|||Log Rank|95% CI of the hazard ratio is obtained using Cox proportional hazards model including a factor of treatment group.||To evaluate the efficacy of D20 bid on gastroesophageal reflux disease (GERD) symptoms in comparison with D20 qd|
1652532|NCT01669811|3040661|Superiority or Other||Difference in proportions|32.8|||<|0.0001|2-Sided|95.0|21.9|42.6||p-value is obtained using chi square method.|Chi-squared|95% CI is obtained using Newcombe-Wilson score method without continuity correction.||To evaluate the efficacy of D20 bid on healing of refractory RE in comparison with D20 qd|
1652533|NCT01669811|3040662|Superiority or Other||Difference in proportions|23.8|||<|0.0001|2-Sided|95.0|14.9|32.6||p-value is obtained using chi square method.|Chi-squared|95% CI is obtained using Newcombe-Wilson score method without continuity correction.||To evaluate the efficacy of D20 bid on healing of refractory RE in comparison with D20 qd|
1652534|NCT01669577|3040696|Superiority or Other||GEE|1.000013|||<|0.023|2-Sided|95.0|1.0|1.000025|||ANOVA|||amount of Infused crystalloids|
1652535|NCT01669577|3040696|Superiority or Other||GEE|0.973987|||<|0.001|2-Sided|95.0|0.965308|0.982744|||ANOVA|||Glasgow coma score|
1652536|NCT01669577|3040696|Superiority or Other||GEE|1.046961|||<|0.004|2-Sided|95.0|1.012521|1.082572|||ANOVA|||lactate|
1652537|NCT01669577|3040696|Superiority or Other||GEE|0.99728|||<|0.001|2-Sided|95.0|0.995791|0.998772|||ANOVA|||diastolic arterial blood pressure|
1652580|NCT01668966|3040757|Superiority or Other|||||||0.3794|||||||Paired t-test|||Statistical analysis at Week 92|
1652581|NCT01668966|3040757|Superiority or Other|||||||0.254|||||||Paired t-test|||Statistical analysis at Week 80|
1652582|NCT01668966|3040757|Superiority or Other|||||||0.8109|||||||Paired t-test|||Statistical analysis at Week 68|
1652583|NCT01668966|3040757|Superiority or Other|||||||0.5031|||||||Paired t-test|||Statistical analysis at Week 56|
1653317|NCT01656850|3042326|Superiority or Other|||||||0.8328|||||||Mixed Models Analysis||||
1652538|NCT01669577|3040696|Superiority or Other||GEE(Generalyzed Estimation Equation)|0.989214|||<|0.001|2-Sided|95.0|0.982855|0.995613||arterial hemoglobin Oxygen saturation|ANOVA|Non parametric(NPar) ANOVA|GEE model (dichotomous response variable)with logit link function. The NPar ANOVA (p<0.1 for death) was the test used for inclusion in the model variables for the final models - backward method, with alpha equal to 0.05.|"significance level of 0.05, power of 0.80, moderate correlation of 0.5 between time periods and assumption that the variability is equal within each factor (non-sphericity). Due to the effect size between 0.1 and 0.5, there was no need for samples larger than 140 patients. A total of 200 patients was defined conservatively, with a margin for possible deaths. The software G*Power 3.1.7 was used for sample size calculation.~Fischer's test, Mann-Whitney, t-test; Non parametric ANOVA and GEE"|
1652539|NCT01669434|3040701|Superiority||Risk Ratio (RR)|0.49||||0.02|2-Sided|95.0|0.28|0.86|||Fisher Exact||||
1652540|NCT01669434|3040702|Superiority||Risk Ratio (RR)|1.95||||0.01|2-Sided|95.0|1.14|3.34|||Fisher Exact||||
1652541|NCT01669434|3040703|Superiority||Risk Ratio (RR)|1.01||||1|2-Sided|95.0|0.81|1.26|||Fisher Exact||||
1652542|NCT01669434|3040704|Superiority||Risk Ratio (RR)|1.2||||1|2-Sided|95.0|0.48|2.99|||Fisher Exact||||
1652543|NCT01669434|3040705|Superiority||Risk Ratio (RR)|0.6||||0.44|2-Sided|95.0|0.23|1.6|||Fisher Exact||||
1652544|NCT01669434|3040706|Superiority||Risk Ratio (RR)|0.81||||0.03|2-Sided|95.0|0.67|0.97|||Fisher Exact||||
1652545|NCT01669421|3040707|Other|||||||0.029|||||||Kruskal-Wallis|||between Week 4 and Week 12|
1652546|NCT01669421|3040707|Other|||||||0.33|||||||t-test, 2 sided|||between Week 8 and Week 12|
1652547|NCT01669421|3040707|Other|between Week 4 and Week 8||||||0.03|||||||t-test, 2 sided|||Desmosine (DES) and isodesmosine (IDES) are used as indicator of elastin degradation. Levels of DES/IDES were measured using high-performance liquid chromatography and tandem mass spectrometry.|
1652548|NCT01669421|3040709|Other|||||||0.07|||||||Kruskal-Wallis|||No power calculation and this is an exploratory pilot analysis We expected cytokines to decrease after subjects receive double dose and a rebound after administering standard dose.|
1652549|NCT01669421|3040710|Other|||||||0.027|||||||Kruskal-Wallis|||M-CSF|
1652550|NCT01669421|3040710|Other|||||||0.8|||||||Kruskal-Wallis|||IL18|
1652551|NCT01669421|3040710|Other|||||||0.9|||||||Kruskal-Wallis|||IL-1a|
1652552|NCT01669421|3040710|Other|||||||0.47|||||||Kruskal-Wallis|||IL15|
1652553|NCT01669421|3040710|Other|||||||0.045|||||||Kruskal-Wallis|||GM-CSF|
1652554|NCT01669421|3040710|Other|||||||0.02|||||||Kruskal-Wallis|||Eotaxin|
1652555|NCT01669421|3040710|Other|||||||0.021|||||||Kruskal-Wallis|||FGF|
1652556|NCT01669421|3040710|Other|||||||0.02|||||||Kruskal-Wallis|||IL-17|
1652557|NCT01669421|3040710|Other|||||||0.68|||||||Kruskal-Wallis|||IL-9|
1652558|NCT01669421|3040710|Other|||||||0.33|||||||Kruskal-Wallis|||IL-8|
1652559|NCT01669421|3040710|Other|Kruskal-Wallis||||||0.035|||||||Kruskal-Wallis|||IL-4|
1652560|NCT01669421|3040710|Other|Data was analyzed with multiple repeat ANOVA for all visits and paired samples were also evaluated.|||||<|0.05|||||||Kruskal-Wallis|||IL-2|
1652561|NCT01669174|3040715|Superiority or Other||Median Difference (Net)|106.63|||<|0.001|2-Sided|90.0|104.39|108.93|||ANCOVA|||Week 24|
1652562|NCT01669174|3040715|Superiority or Other||Median Difference (Net)|108.63|||<|0.001|2-Sided|90.0|106.31|111.0|||ANCOVA|||Week 16|
1652563|NCT01669174|3040715|Superiority or Other||Median Difference (Net)|107.75|||<|0.001|2-Sided|90.0|106.18|109.35|||ANCOVA|||Week 8|
1652564|NCT01669174|3040715|Superiority or Other||Mean Difference (Net)|106.1|||<|0.001|2-Sided|90.0|104.64|107.58|||ANCOVA|||Week 4|
1652565|NCT01669122|3040719|Superiority or Other||Median Difference (Final Values)|0.0||||0.0063|2-Sided|95.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.|
1652566|NCT01669122|3040719|Superiority or Other||Median Difference (Final Values)|0.0||||0.5695|2-Sided|95.0|-0.25|0.25|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.|
1652567|NCT01669122|3040719|Superiority or Other||Median Difference (Final Values)|0.0||||0.2208|2-Sided|95.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Based on Hodges Lehmann estimate|Null hypothesis considered no difference in the treatments being compared.|
1652568|NCT01669122|3040720|Non-Inferiority or Equivalence|Testing bioequivalence|Treatment Ratio|0.93|||||2-Sided|90.0|0.9|0.96||||||Null hypothesis considered no difference in the treatments being compared.|
1652569|NCT01669122|3040720|Non-Inferiority or Equivalence|Testing bioequivalence|Treatment Ratio|0.96|||||2-Sided|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.|
1652570|NCT01669122|3040720|Non-Inferiority or Equivalence|Testing bioequivalence|Treatment Ratio|0.96|||||2-Sided|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.|
1652571|NCT01669122|3040721|Non-Inferiority or Equivalence|Testing Bioequivalence|Treatment Ratio|0.92|||||2-Sided|90.0|0.88|0.96||||||Null hypothesis considered no difference in the treatments being compared.|
1652572|NCT01669122|3040721|Non-Inferiority or Equivalence|Testing Bioequivalence|Treatment Ratio|0.99|||||2-Sided|90.0|0.94|1.03||||||Null hypothesis considered no difference in the treatments being compared.|
1652573|NCT01669122|3040721|Non-Inferiority or Equivalence|Testing bioequivalence|Treatment Ratio|0.97|||||2-Sided|90.0|0.93|1.02||||||Null hypothesis considered no difference in the treatments being compared.|
1652574|NCT01669122|3040722|Non-Inferiority or Equivalence|Testing Bioequivalence|Treatment Ratio|0.94|||||2-Sided|90.0|0.91|0.97||||||Null hypothesis considered no difference in the treatments being compared.|
1652575|NCT01669122|3040722|Non-Inferiority or Equivalence|Testing Bioequivalence|Treatment Ratio|0.96|||||2-Sided|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.|
1652576|NCT01669122|3040722|Non-Inferiority or Equivalence|Testing Bioequivalence|Treatment Ratio|0.96|||||2-Sided|90.0|0.93|0.99||||||Null hypothesis considered no difference in the treatments being compared.|
1652577|NCT01668966|3040757|Superiority or Other|||||||0.0511|||||||Paired t-test|||Statistical analysis at Follow-up visit 2|
1652578|NCT01668966|3040757|Superiority or Other|||||||0.4685|||||||Paired t-test|||Statistical analysis at Follow-up visit 1|
1652584|NCT01668966|3040757|Superiority or Other|||||||0.2773|||||||Paired t-test|||Statistical analysis at Week 48|
1652585|NCT01668966|3040757|Superiority or Other|||||||0.9602|||||||Paired t-test|||Statistical analysis at Week 36|
1652586|NCT01668966|3040757|Superiority or Other|||||||0.9247|||||||Paired t-test|||Statistical analysis at Week 24|
1652587|NCT01668966|3040757|Superiority or Other|||||||0.3299|||||||Paired t-test|||Statistical analysis at Week 12|
1652588|NCT01668966|3040758|Superiority or Other|||||||0.07|||||||Paired t-test|||Statistical analysis at Follow-up visit 2|
1652589|NCT01668966|3040758|Superiority or Other|||||||0.116|||||||Paired t-test|||Statistical analysis at Follow-up visit 1|
1652590|NCT01668966|3040758|Superiority or Other|||||||0.087|||||||Paired t-test|||Statistical analysis at Week 104|
1652591|NCT01668966|3040758|Superiority or Other|||||||0.201|||||||Paired t-test|||Statistical analysis at Week 92|
1652592|NCT01668966|3040758|Superiority or Other|||||||0.119|||||||Paired t-test|||Statistical analysis at Week 80|
1652593|NCT01668966|3040758|Superiority or Other|||||||0.716|||||||Paired t-test|||Statistical analysis at Week 68|
1652594|NCT01668966|3040758|Superiority or Other|||||||0.329|||||||Paired t-test|||Statistical analysis at Week 56|
1652595|NCT01668966|3040758|Superiority or Other|||||||0.788|||||||Paired t-test|||Statistical analysis at Week 48|
1652596|NCT01668966|3040758|Superiority or Other|||||||0.594|||||||Paired t-test|||Statistical analysis at Week 36|
1652597|NCT01668966|3040758|Superiority or Other|||||||0.637|||||||Paired t-test|||Statistical analysis at Week 24|
1652598|NCT01668966|3040758|Superiority or Other|||||||0.565|||||||Paired t-test|||Statistical analysis at Week 12|
1652599|NCT01668966|3040759|Superiority or Other|||||||0.101|||||||Paired t-test|||Statistical analysis at Follow-up visit 2|
1652600|NCT01668966|3040759|Superiority or Other|||||||0.208|||||||Paired t-test|||Statistical analysis at Follow-up visit 1|
1652601|NCT01668966|3040759|Superiority or Other|||||||0.218|||||||Paired t-test|||Statistical analysis at Week 104|
1652602|NCT01668966|3040759|Superiority or Other|||||||0.602|||||||Paired t-test|||Statistical analysis at Week 92|
1652603|NCT01668966|3040759|Superiority or Other|||||||0.246|||||||Paired t-test|||Statistical analysis at Week 80|
1652604|NCT01668966|3040759|Superiority or Other|||||||0.539|||||||Paired t-test|||Statistical analysis at Week 68|
1652605|NCT01668966|3040759|Superiority or Other|||||||0.834|||||||Paired t-test|||Statistical analysis at Week 56|
1652606|NCT01668966|3040759|Superiority or Other|||||||0.92|||||||Paired t-test|||Statistical analysis at Week 48|
1652607|NCT01668966|3040759|Superiority or Other|||||||0.401|||||||Paired t-test|||Statistical analysis at Week 36|
1652608|NCT01668966|3040759|Superiority or Other|||||||0.414|||||||Paired t-test|||Statistical analysis at Week 24|
1652609|NCT01668966|3040759|Superiority or Other|||||||0.445|||||||Paired t-test|||Statistical analysis at Week 12|
1652610|NCT01668966|3040760|Superiority or Other|||||||0.185|||||||Paired t-test|||Statistical analysis at Follow-up visit 2|
1652611|NCT01668966|3040760|Superiority or Other|||||||0.375|||||||Paired t-test|||Statistical analysis at Follow-up visit 1|
1652612|NCT01668966|3040760|Superiority or Other|||||||0.246|||||||Paired t-test|||Statistical analysis at Week 104|
1652613|NCT01668966|3040760|Superiority or Other|||||||0.485|||||||Paired t-test|||Statistical analysis at Week 92|
1652614|NCT01668966|3040760|Superiority or Other|||||||0.315|||||||Paired t-test|||Statistical analysis at Week 80|
1652615|NCT01668966|3040760|Superiority or Other|||||||0.832|||||||Paired t-test|||Statistical analysis at Week 68|
1652616|NCT01668966|3040760|Superiority or Other|||||||0.928|||||||Paired t-test|||Statistical analysis at Week 56|
1652617|NCT01668966|3040760|Superiority or Other|||||||0.952|||||||Paired t-test|||Statistical analysis at Week 48|
1652618|NCT01668966|3040760|Superiority or Other|||||||0.642|||||||Paired t-test|||Statistical analysis at Week 36|
1652619|NCT01668966|3040760|Superiority or Other|||||||0.624|||||||Paired t-test|||Statistical analysis at Week 24|
1652620|NCT01668966|3040760|Superiority or Other|||||||0.934|||||||Paired t-test|||Statistical analysis at Week 12|
1652621|NCT01668966|3040763|Superiority or Other|||||||0.4312|||||||Paired t-test|||Statistical analysis at Follow-up visit 2|
1652622|NCT01668966|3040763|Superiority or Other|||||||0.1605|||||||Paired t-test|||Statistical analysis at Week 104|
1652623|NCT01668966|3040763|Superiority or Other|||||||0.3391|||||||Paired t-test|||Statistical analysis at Week 92|
1652624|NCT01668966|3040763|Superiority or Other|||||||0.2814|||||||Paired t-test|||Statistical analysis at Week 80|
1652625|NCT01668966|3040763|Superiority or Other|||||||0.6235|||||||Paired t-test|||Statistical analysis at Week 68|
1652626|NCT01668966|3040763|Superiority or Other|||||||0.0193|||||||Paired t-test|||Statistical analysis at Week 56|
1652627|NCT01668966|3040763|Superiority or Other|||||||0.0203|||||||Paired t-test|||Statistical analysis at Week 48|
1652628|NCT01668966|3040763|Superiority or Other|||||||0.0321|||||||Paired t-test|||Statistical analysis at Week 36|
1652629|NCT01668966|3040763|Superiority or Other|||||||0.1084|||||||Paired t-test|||Statistical analysis at Week 24|
1652630|NCT01668966|3040763|Superiority or Other|||||||0.2388|||||||Paired t-test|||Statistical analysis at Week 12|
1652631|NCT01668966|3040764|Superiority or Other||||||<|0.0001|||||||Paired t-test|||Statistical analysis at Follow-up visit 2|
1652632|NCT01668966|3040764|Superiority or Other||||||<|0.0624|||||||Paired t-test|||Statistical analysis at Follow-up visit 1|
1652633|NCT01668966|3040764|Superiority or Other||||||<|0.4877|||||||Paired t-test|||Statistical analysis at Week 104|
1652634|NCT01668966|3040764|Superiority or Other||||||<|0.4772|||||||Paired t-test|||Statistical analysis at Week 92|
1652635|NCT01668966|3040764|Superiority or Other||||||<|0.6017|||||||Paired t-test|||Statistical analysis at Week 80|
1652636|NCT01668966|3040764|Superiority or Other||||||<|0.0679|||||||Paired t-test|||Statistical analysis at Week 68|
1652637|NCT01668966|3040764|Superiority or Other||||||<|0.1401|||||||Paired t-test|||Statistical analysis at Week 56|
1652638|NCT01668966|3040764|Superiority or Other||||||<|0.5393|||||||Paired t-test|||Statistical analysis at Week 48|
1652639|NCT01668966|3040764|Superiority or Other||||||<|0.248|||||||Paired t-test|||Statistical analysis at Week 36|
1652640|NCT01668966|3040764|Superiority or Other||||||<|0.0616|||||||Paired t-test|||Statistical analysis at Week 24|
1652641|NCT01668966|3040764|Superiority or Other||||||<|0.0624|||||||Paired t-test|||Statistical analysis at Week 12|
1652642|NCT01668966|3040765|Superiority or Other|||||||0.0522|||||||Paired t-test|||Statistical analysis at Follow-up visit 2|
1652643|NCT01668966|3040765|Superiority or Other|||||||0.4821|||||||Paired t-test|||Statistical analysis at Follow-up visit 1|
1652644|NCT01668966|3040765|Superiority or Other|||||||0.4478|||||||Paired t-test|||Statistical analysis at Week 104|
1652645|NCT01668966|3040765|Superiority or Other|||||||0.605|||||||Paired t-test|||Statistical analysis at Week 92|
1652646|NCT01668966|3040765|Superiority or Other|||||||0.7649|||||||Paired t-test|||Statistical analysis at Week 80|
1652647|NCT01668966|3040765|Superiority or Other|||||||0.8822|||||||Paired t-test|||Statistical analysis at Week 68|
1652648|NCT01668966|3040765|Superiority or Other|||||||0.2164|||||||Paired t-test|||Statistical analysis at Week 56|
1652649|NCT01668966|3040765|Superiority or Other|||||||0.3102|||||||Paired t-test|||Statistical analysis at Week 48|
1652650|NCT01668966|3040765|Superiority or Other|||||||0.2249|||||||Paired t-test|||Statistical analysis at Week 36|
1652651|NCT01668966|3040765|Superiority or Other|||||||0.2992|||||||Paired t-test|||Statistical analysis at Week 24|
1652652|NCT01668966|3040765|Superiority or Other|||||||0.1853|||||||Paired t-test|||Statistical analysis at Week 12|
1652653|NCT01668966|3040766|Superiority or Other|||||||0.009|||||||Paired t-test|||Statistical analysis at Follow-up visit 2|
1652654|NCT01668966|3040766|Superiority or Other|||||||0.243|||||||Paired t-test|||Statistical analysis at Follow-up visit 1|
1652655|NCT01668966|3040766|Superiority or Other|||||||0.044|||||||Paired t-test|||Statistical analysis at Week 104|
1652656|NCT01668966|3040766|Superiority or Other|||||||0.593|||||||Paired t-test|||Statistical analysis at Week 92|
1652657|NCT01668966|3040766|Superiority or Other|||||||0.533|||||||Paired t-test|||Statistical analysis at Week 80|
1652658|NCT01668966|3040766|Superiority or Other|||||||0.343|||||||Paired t-test|||Statistical analysis at Week 68|
1652659|NCT01668966|3040766|Superiority or Other|||||||0.21|||||||Paired t-test|||Statistical analysis at Week 56|
1652660|NCT01668966|3040766|Superiority or Other|||||||0.167|||||||Paired t-test|||Statistical analysis at Week 48|
1652661|NCT01668966|3040766|Superiority or Other|||||||0.116|||||||Paired t-test|||Statistical analysis at Week 36|
1652662|NCT01668966|3040766|Superiority or Other|||||||0.139|||||||Paired t-test|||Statistical analysis at Week 24|
1652663|NCT01668966|3040766|Superiority or Other|||||||0.101|||||||Paired t-test|||Statistical analysis at Week 12|
1652664|NCT01668797|3040786|Superiority or Other||Mean Difference (Final Values)|-0.72||||0.0608|2-Sided|95.0|-1.47|0.03|||ANCOVA|||Statistical analysis at Week 52.|
1652665|NCT01668797|3040786|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.0724|2-Sided|95.0|-1.47|0.06|||ANCOVA|||Statistical analysis at Week 36.|
1652666|NCT01668797|3040786|Superiority or Other||Mean Difference (Final Values)|-0.58||||0.1417|2-Sided|95.0|-1.35|0.19|||ANCOVA|||Statistical analysis at Week 24.|
1652667|NCT01668797|3040786|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.1599|2-Sided|95.0|-1.33|0.22|||ANCOVA|||Statistical analysis at Week 12.|
1652668|NCT01668797|3040786|Superiority or Other||Mean Difference (Final Values)|-0.67||||0.0467|2-Sided|95.0|-1.32|-0.06|||ANCOVA|||Statistical analysis at Week 6.|
1652669|NCT01668797|3040787|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.4506|2-Sided|95.0|-0.62|0.28|||Mixed Models Analysis|||Statistical analysis at across visits.|
1652670|NCT01668797|3040787|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.7437|2-Sided|95.0|-1.68|1.21|||Mixed Models Analysis|||Statistical analysis at Week 52.|
1652671|NCT01668797|3040787|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.6257|2-Sided|95.0|-1.25|0.76|||Mixed Models Analysis|||Statistical analysis at Week 36.|
1652672|NCT01668797|3040787|Superiority or Other||Mean Difference (Final Values)|0.03||||0.9417|2-Sided|95.0|-0.81|0.87|||Mixed Models Analysis|||Statistical analysis at Week 24.|
1652673|NCT01668797|3040787|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.5466|2-Sided|95.0|-1.04|0.55|||Mixed Models Analysis|||Statistical analysis at Week 12.|
1652674|NCT01668797|3040787|Superiority or Other||Mean Difference (Final Values)|-0.47||||0.164|2-Sided|95.0|-1.14|0.19|||Mixed Models Analysis|||Statistical analysis at Week 6.|
1652675|NCT01668797|3040788|Superiority or Other||Mean Difference (Final Values)|-1.26||||0.0046|2-Sided|95.0|-2.12|-0.39|||ANCOVA|||Statistical analysis at Week 52.|
1652676|NCT01668797|3040788|Superiority or Other||Mean Difference (Final Values)|-1.07||||0.0144|2-Sided|95.0|-1.92|-0.22|||ANCOVA|||Statistical analysis at Week 36.|
1652677|NCT01668797|3040788|Superiority or Other||Mean Difference (Final Values)|-0.81||||0.0635|2-Sided|95.0|-1.66|0.05|||ANCOVA|||Statistical analysis at Week 24.|
1652678|NCT01668797|3040788|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.2437|2-Sided|95.0|-1.13|0.29|||ANCOVA|||Statistical analysis at Week 12.|
1652679|NCT01668797|3040788|Superiority or Other||Mean Difference (Final Values)|-0.33||||0.2135|2-Sided|95.0|-0.86|0.19|||ANCOVA|||Statistical analysis at Week 6.|
1652680|NCT01668797|3040789|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.0021|2-Sided|95.0|-1.08|-0.24|||Mixed Models Analysis|||Statistical analysis at across visits.|
1652681|NCT01668797|3040789|Superiority or Other||Mean Difference (Final Values)|-1.14||||0.0875|2-Sided|95.0|-2.46|0.18|||Mixed Models Analysis|||Statistical analysis at Week 52.|
1652682|NCT01668797|3040789|Superiority or Other||Mean Difference (Final Values)|-1.07||||0.0179|2-Sided|95.0|-1.95|-0.19|||Mixed Models Analysis|||Statistical analysis at Week 36.|
1652683|NCT01668797|3040789|Superiority or Other||Mean Difference (Final Values)|-0.44||||0.2696|2-Sided|95.0|-1.23|0.35|||Mixed Models Analysis|||Statistical analysis at Week 24.|
1653318|NCT01656850|3042327|Superiority or Other|||||||0.6263|||||||Mixed Models Analysis||||
1652684|NCT01668797|3040789|Superiority or Other||Mean Difference (Final Values)|-0.49||||0.2154|2-Sided|95.0|-1.27|0.29|||Mixed Models Analysis|||Statistical analysis at Week 12.|
1652685|NCT01668797|3040789|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.1465|2-Sided|95.0|-0.85|0.13|||Mixed Models Analysis|||Statistical analysis at Week 6.|
1652686|NCT01668797|3040790|Superiority or Other||Mean Difference (Final Values)|-1.69||||0.0035|2-Sided|95.0|-2.81|-0.56|||ANCOVA|||Statistical analysis at Week 52.|
1652687|NCT01668797|3040790|Superiority or Other||Mean Difference (Final Values)|-1.94||||0.0004|2-Sided|95.0|-3.0|-0.89|||ANCOVA|||Statistical analysis at Week 36.|
1652688|NCT01668797|3040790|Superiority or Other||Mean Difference (Final Values)|-2.05||||0.0001|2-Sided|95.0|-3.08|-1.01|||ANCOVA|||Statistical analysis at Week 24.|
1652689|NCT01668797|3040790|Superiority or Other||Mean Difference (Final Values)|-1.37||||0.0051|2-Sided|95.0|-2.33|-0.42|||ANCOVA|||Statistical analysis at Week 12.|
1652690|NCT01668797|3040790|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.1062|2-Sided|95.0|-1.44|0.14|||ANCOVA|||Statistical analysis at Week 6.|
1652691|NCT01668797|3040791|Superiority or Other||Mean Difference (Final Values)|-0.99||||0.0029|2-Sided|95.0|-1.63|-0.34|||Mixed Models Analysis|||Statistical analysis at across visits.|
1652692|NCT01668797|3040791|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.9632|2-Sided|95.0|-3.32|3.17|||Mixed Models Analysis|||Statistical analysis at Week 52.|
1652693|NCT01668797|3040791|Superiority or Other||Mean Difference (Final Values)|-1.48||||0.0293|2-Sided|95.0|-2.8|-0.15|||Mixed Models Analysis|||Statistical analysis at Week 36.|
1652694|NCT01668797|3040791|Superiority or Other||Mean Difference (Final Values)|-1.53||||0.0024|2-Sided|95.0|-2.51|-0.56|||Mixed Models Analysis|||Statistical analysis at Week 24.|
1652695|NCT01668797|3040791|Superiority or Other||Mean Difference (Final Values)|-1.13||||0.0368|2-Sided|95.0|-2.19|-0.07|||Mixed Models Analysis|||Statistical analysis at Week 12.|
1652696|NCT01668797|3040791|Superiority or Other||Mean Difference (Final Values)|-0.51||||0.2251|2-Sided|95.0|-1.33|0.31|||Mixed Models Analysis|||Statistical analysis at Week 6.|
1652697|NCT01668797|3040792|Superiority or Other||Mean Difference (Final Values)|-1.23||||0.063|2-Sided|95.0|-2.52|0.07|||ANCOVA|||Statistical analysis at Week 52.|
1652698|NCT01668797|3040792|Superiority or Other||Mean Difference (Final Values)|-1.63||||0.0085|2-Sided|95.0|-2.84|-0.42|||ANCOVA|||Statistical analysis at Week 36.|
1652699|NCT01668797|3040792|Superiority or Other||Mean Difference (Final Values)|-1.59||||0.0065|2-Sided|95.0|-2.72|-0.45|||ANCOVA|||Statistical analysis at Week 24.|
1652700|NCT01668797|3040792|Superiority or Other||Mean Difference (Final Values)|-1.24||||0.0276|2-Sided|95.0|-2.35|-0.14|||ANCOVA|||Statistical analysis at Week 12.|
1652701|NCT01668797|3040792|Superiority or Other||Mean Difference (Final Values)|-0.85||||0.0707|2-Sided|95.0|-1.78|0.07|||ANCOVA|||Statistical analysis at Week 6.|
1652702|NCT01668797|3040793|Superiority or Other||Mean Difference (Final Values)|-0.52||||0.2154|2-Sided|95.0|-1.34|0.31|||Mixed Models Analysis|||Statistical analysis at across visits.|
1652703|NCT01668797|3040793|Superiority or Other||Mean Difference (Final Values)|0.31||||0.8927|2-Sided|95.0|-4.4|5.02|||Mixed Models Analysis|||Statistical analysis at Week 52.|
1652704|NCT01668797|3040793|Superiority or Other||Mean Difference (Final Values)|-1.51||||0.0444|2-Sided|95.0|-2.97|-0.04|||Mixed Models Analysis|||Statistical analysis at Week 36.|
1652705|NCT01668797|3040793|Superiority or Other||Mean Difference (Final Values)|-1.17||||0.0436|2-Sided|95.0|-2.3|-0.03|||Mixed Models Analysis|||Statistical analysis at Week 24.|
1652706|NCT01668797|3040793|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.2007|2-Sided|95.0|-2.04|0.43|||Mixed Models Analysis|||Statistical analysis at Week 12.|
1652707|NCT01668797|3040793|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.1969|2-Sided|95.0|-1.66|0.35|||Mixed Models Analysis|||Statistical analysis at Week 6.|
1652708|NCT01668797|3040794|Superiority or Other||Mean Difference (Final Values)|-3.44|||<|0.0001|2-Sided|95.0|-4.99|-1.89|||ANCOVA|||Statistical analysis at Week 52.|
1652709|NCT01668797|3040794|Superiority or Other||Mean Difference (Final Values)|-3.09|||<|0.0001|2-Sided|95.0|-4.63|-1.54|||ANCOVA|||Statistical analysis at Week 36.|
1652710|NCT01668797|3040794|Superiority or Other||Mean Difference (Final Values)|-2.83|||<|0.0004|2-Sided|95.0|-4.39|-1.27|||ANCOVA|||Statistical analysis at Week 24.|
1652711|NCT01668797|3040794|Superiority or Other||Mean Difference (Final Values)|-1.93|||<|0.0089|2-Sided|95.0|-3.38|-0.49|||ANCOVA|||Statistical analysis at Week 12.|
1652712|NCT01668797|3040794|Superiority or Other||Mean Difference (Final Values)|-1.08|||<|0.0695|2-Sided|95.0|-2.26|0.09|||ANCOVA|||Statistical analysis at Week 6.|
1652713|NCT01668797|3040795|Superiority or Other||Mean Difference (Final Values)|-1.91||||0.0001|2-Sided|95.0|-2.84|-0.97|||Mixed Models Analysis|||Statistical analysis at across visits.|
1652714|NCT01668797|3040795|Superiority or Other||Mean Difference (Final Values)|-3.4||||0.0136|2-Sided|95.0|-6.05|-0.75|||Mixed Models Analysis|||Statistical analysis at Week 52|
1652715|NCT01668797|3040795|Superiority or Other||Mean Difference (Final Values)|-2.29||||0.0074|2-Sided|95.0|-3.94|-0.64|||Mixed Models Analysis|||Statistical analysis at Week 36.|
1652716|NCT01668797|3040795|Superiority or Other||Mean Difference (Final Values)|-1.59||||0.0462|2-Sided|95.0|-3.15|0.03|||Mixed Models Analysis|||Statistical analysis at Week 24.|
1652717|NCT01668797|3040795|Superiority or Other||Mean Difference (Final Values)|-2.02||||0.0128|2-Sided|95.0|-3.6|-0.44|||Mixed Models Analysis|||Statistical analysis at Week 12.|
1652718|NCT01668797|3040795|Superiority or Other||Mean Difference (Final Values)|-1.34||||0.0288|2-Sided|95.0|-2.54|-0.14|||Mixed Models Analysis|||Statistical analysis at Week 6.|
1652719|NCT01668797|3040796|Superiority or Other||Mean Difference (Final Values)|-1.54||||0.0023|2-Sided|95.0|-2.52|-0.56|||ANCOVA|||Statistical analysis at Week 52.|
1652720|NCT01668797|3040796|Superiority or Other||Mean Difference (Final Values)|-1.34||||0.0071|2-Sided|95.0|-2.31|-0.37|||ANCOVA|||Statistical analysis at Week 36.|
1652721|NCT01668797|3040796|Superiority or Other||Mean Difference (Final Values)|-1.08||||0.0323|2-Sided|95.0|-2.06|-0.09|||ANCOVA|||Statistical analysis at Week 24.|
1653319|NCT01656850|3042328|Superiority or Other|||||||0.557|||||||Mixed Models Analysis||||
1652722|NCT01668797|3040796|Superiority or Other||Mean Difference (Final Values)|-0.63||||0.143|2-Sided|95.0|-1.47|0.21|||ANCOVA|||Statistical analysis at Week 12.|
1652723|NCT01668797|3040796|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.1852|2-Sided|95.0|-1.06|0.21|||ANCOVA|||Statistical analysis at Week 6.|
1652724|NCT01668797|3040797|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.0077|2-Sided|95.0|-1.12|-0.17|||Mixed Models Analysis|||Statistical analysis at across visits.|
1652725|NCT01668797|3040797|Superiority or Other||Mean Difference (Final Values)|-1.03||||0.1803|2-Sided|95.0|-2.58|0.51|||Mixed Models Analysis|||Statistical analysis at Week 52.|
1652726|NCT01668797|3040797|Superiority or Other||Mean Difference (Final Values)|-1.14||||0.0286|2-Sided|95.0|-2.16|-0.12|||Mixed Models Analysis|||Statistical analysis at Week 36.|
1652727|NCT01668797|3040797|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.2815|2-Sided|95.0|-1.43|0.42|||Mixed Models Analysis|||Statistical analysis at Week 24.|
1652728|NCT01668797|3040797|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.1685|2-Sided|95.0|-1.61|0.28|||Mixed Models Analysis|||Statistical analysis at Week 12.|
1652729|NCT01668797|3040797|Superiority or Other||Mean Difference (Final Values)|-0.43||||0.1577|2-Sided|95.0|-1.02|0.17|||Mixed Models Analysis|||Statistical analysis at Week 6.|
1652730|NCT01668797|3040798|Superiority or Other|||||||0.0014|||||||Log Rank||||
1652731|NCT01668797|3040799|Superiority or Other||Mean Difference (Final Values)|6.55||||0.0001|2-Sided|95.0|3.28|9.83|||ANCOVA|||Statistical analysis at Week 52.|
1652732|NCT01668797|3040799|Superiority or Other||Mean Difference (Final Values)|6.81|||<|0.0001|2-Sided|95.0|3.61|10.0|||ANCOVA|||Statistical analysis at Week 36.|
1652733|NCT01668797|3040799|Superiority or Other||Mean Difference (Final Values)|5.36|||<|0.0014|2-Sided|95.0|2.1|8.62|||ANCOVA|||Statistical analysis at Week 24.|
1652734|NCT01668797|3040799|Superiority or Other||Mean Difference (Final Values)|3.88|||<|0.0111|2-Sided|95.0|0.9|6.86|||ANCOVA|||Statistical analysis at Week 12.|
1652735|NCT01668797|3040800|Superiority or Other||Mean Difference (Final Values)|3.66||||0.0281|2-Sided|95.0|0.41|6.92|||Mixed Models Analysis|||Statistical analysis at across visits.|
1652736|NCT01668797|3040800|Superiority or Other||Mean Difference (Final Values)|5.88||||0.0522|2-Sided|95.0|-0.06|11.82|||Mixed Models Analysis|||Statistical analysis at Week 52.|
1652737|NCT01668797|3040800|Superiority or Other||Mean Difference (Final Values)|4.5||||0.0331|2-Sided|95.0|0.38|8.63|||Mixed Models Analysis|||Statistical analysis at Week 36.|
1652738|NCT01668797|3040800|Superiority or Other||Mean Difference (Final Values)|2.66||||0.1765|2-Sided|95.0|-1.22|6.54|||Mixed Models Analysis|||Statistical analysis at Week 24.|
1652739|NCT01668797|3040800|Superiority or Other||Mean Difference (Final Values)|1.61||||0.329|2-Sided|95.0|-1.65|4.88|||Mixed Models Analysis|||Statistical analysis at Week 12.|
1652740|NCT01668797|3040801|Superiority or Other||Mean Difference (Final Values)|4.75||||0.0071|2-Sided|95.0|1.31|8.18|||ANCOVA|||Statistical analysis at Week 52.|
1652741|NCT01668797|3040801|Superiority or Other||Mean Difference (Final Values)|3.79||||0.0285|2-Sided|95.0|0.4|7.17|||ANCOVA|||Statistical analysis at Week 24.|
1652742|NCT01668797|3040802|Superiority or Other||Mean Difference (Final Values)|3.55||||0.2347|2-Sided|95.0|-2.41|9.5|||Mixed Models Analysis|||Statistical analysis at across visits.|
1652743|NCT01668797|3040802|Superiority or Other||Mean Difference (Final Values)|6.08||||0.1677|2-Sided|95.0|-2.71|14.87|||Mixed Models Analysis|||Statistical analysis at Week 52.|
1652744|NCT01668797|3040802|Superiority or Other||Mean Difference (Final Values)|1.01||||0.6525|2-Sided|95.0|-3.47|5.49|||Mixed Models Analysis|||Statistical analysis at Week 24.|
1652745|NCT01668797|3040803|Superiority or Other||Treatment difference|-0.61||||0.0009|2-Sided|95.0|-0.96|-0.25|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 52.|
1652746|NCT01668797|3040803|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.0004|2-Sided|95.0|-1.02|-0.3|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 36.|
1652747|NCT01668797|3040803|Superiority or Other||Mean Difference (Final Values)|-0.61||||0.001|2-Sided|95.0|-0.97|-0.24|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 24.|
1652748|NCT01668797|3040803|Superiority or Other||Mean Difference (Final Values)|-0.41||||0.0185|2-Sided|95.0|-0.75|-0.07|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 12.|
1652749|NCT01668797|3040803|Superiority or Other||Mean Difference (Final Values)|-0.31||||0.0387|2-Sided|95.0|-0.6|-0.2|||Cochran-Mantel-Haenszel|||Statistical analysis at Week 6.|
1652750|NCT01668797|3040804|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.0002|2-Sided|95.0|-0.79|-0.26|||ANCOVA|||Statistical analysis at Week 52|
1652751|NCT01668797|3040804|Superiority or Other||Mean Difference (Final Values)|-0.56|||<|0.0001|2-Sided|95.0|-0.82|-0.3|||ANCOVA|||Statistical analysis at Week 36.|
1652752|NCT01668797|3040804|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.0002|2-Sided|95.0|-0.76|-0.24|||ANCOVA|||Statistical analysis at Week 24.|
1652753|NCT01668797|3040804|Superiority or Other||Mean Difference (Final Values)|-0.36|||<|0.0056|2-Sided|95.0|-0.62|-0.11|||ANCOVA|||Statistical analysis at Week 12.|
1652754|NCT01668797|3040804|Superiority or Other||Mean Difference (Final Values)|-0.25|||<|0.0284|2-Sided|95.0|-0.47|-0.03|||ANCOVA|||Statistical analysis at Week 6.|
1652755|NCT01668797|3040805|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.0006|2-Sided|95.0|-0.54|-0.15|||Mixed Models Analysis|||Statistical analysis at across visits.|
1652756|NCT01668797|3040805|Superiority or Other||Mean Difference (Final Values)|-0.51||||0.078|2-Sided|95.0|-1.09|0.06|||Mixed Models Analysis|||Statistical analysis at Week 52.|
1652757|NCT01668797|3040805|Superiority or Other||Mean Difference (Final Values)|-0.56||||0.0007|2-Sided|95.0|-0.87|-0.25|||Mixed Models Analysis|||Statistical analysis at Week 36.|
1652758|NCT01668797|3040805|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.0105|2-Sided|95.0|-0.64|-0.09|||Mixed Models Analysis|||Statistical analysis at Week 24.|
1652759|NCT01668797|3040805|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.0117|2-Sided|95.0|-0.68|-0.09|||Mixed Models Analysis|||Statistical analysis at Week 12.|
1652760|NCT01668797|3040805|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.0279|2-Sided|95.0|-0.53|-0.03|||Mixed Models Analysis|||Statistical analysis at Week 6.|
1652761|NCT01668797|3040806|Superiority or Other||Mean Difference (Final Values)|-1.24||||0.0516|2-Sided|95.0|-2.5|0.01|||ANCOVA|||Statistical analysis at Week 52|
1652762|NCT01668797|3040806|Superiority or Other||Mean Difference (Final Values)|-1.57||||0.0101|2-Sided|95.0|-2.77|-0.38|||ANCOVA|||Statistical analysis at Week 36.|
1652763|NCT01668797|3040806|Superiority or Other||Mean Difference (Final Values)|-1.55||||0.0078|2-Sided|95.0|-2.69|-0.42|||ANCOVA|||Statistical analysis at Week 24.|
1652764|NCT01668797|3040806|Superiority or Other||Mean Difference (Final Values)|-1.22||||0.0264|2-Sided|95.0|-2.3|-0.15|||ANCOVA|||Statistical analysis at Week 12.|
1652765|NCT01668797|3040806|Superiority or Other||Mean Difference (Final Values)|-0.76||||0.0981|2-Sided|95.0|-1.65|0.14|||ANCOVA|||Statistical analysis at Week 6.|
1652766|NCT01668797|3040807|Superiority or Other||Mean Difference (Final Values)|-0.47||||0.2258|2-Sided|95.0|-1.24|0.3|||Mixed Models Analysis|||Statistical analysis at across visits.|
1652767|NCT01668797|3040807|Superiority or Other||Mean Difference (Final Values)|0.43||||0.847|2-Sided|95.0|-4.14|5.0|||Mixed Models Analysis|||Statistical analysis at Week 52.|
1652768|NCT01668797|3040807|Superiority or Other||Mean Difference (Final Values)|-1.05||||0.1396|2-Sided|95.0|-2.44|0.35|||Mixed Models Analysis|||Statistical analysis at Week 36.|
1652769|NCT01668797|3040807|Superiority or Other||Mean Difference (Final Values)|-0.95||||0.0939|2-Sided|95.0|-2.07|0.16|||Mixed Models Analysis|||Statistical analysis at Week 24.|
1652770|NCT01668797|3040807|Superiority or Other||Mean Difference (Final Values)|-0.78||||0.2001|2-Sided|95.0|-1.97|0.42|||Mixed Models Analysis|||Statistical analysis at Week 12.|
1652771|NCT01668797|3040807|Superiority or Other||Mean Difference (Final Values)|-0.69||||0.165|2-Sided|95.0|-1.66|0.29|||Mixed Models Analysis|||Statistical analysis at Week 6.|
1652772|NCT01668797|3040808|Superiority or Other||Mean Difference (Final Values)|-3.18|||<|0.0001|2-Sided|95.0|-4.7|-1.66|||ANCOVA|||Statistical analysis at Week 52|
1652773|NCT01668797|3040808|Superiority or Other||Mean Difference (Final Values)|-2.94|||<|0.0001|2-Sided|95.0|-4.43|-1.44|||ANCOVA|||Statistical analysis at Week 36.|
1652774|NCT01668797|3040808|Superiority or Other||Mean Difference (Final Values)|-2.74|||<|0.0005|2-Sided|95.0|-4.26|-1.22|||ANCOVA|||Statistical analysis at Week 24.|
1652775|NCT01668797|3040808|Superiority or Other||Mean Difference (Final Values)|-1.86|||<|0.0089|2-Sided|95.0|-3.25|-0.47|||ANOVA|||Statistical analysis at Week 12.|
1652776|NCT01668797|3040808|Superiority or Other||Mean Difference (Final Values)|-0.94|||<|0.1093|2-Sided|95.0|-2.1|0.21|||ANCOVA|||Statistical analysis at Week 6.|
1652777|NCT01668797|3040809|Superiority or Other||Mean Difference (Final Values)|-1.6|||<|0.0001|2-Sided|95.0|-2.32|-0.88|||Mixed Models Analysis|||Statistical analysis at across visits.|
1652778|NCT01668797|3040809|Superiority or Other||Mean Difference (Final Values)|-2.71|||<|0.339|2-Sided|95.0|-5.2|-0.22|||Mixed Models Analysis|||Statistical analysis at Week 52.|
1652779|NCT01668797|3040809|Superiority or Other||Mean Difference (Final Values)|-1.88|||<|0.0053|2-Sided|95.0|-3.19|-0.58|||Mixed Models Analysis|||Statistical analysis at Week 36.|
1652780|NCT01668797|3040809|Superiority or Other||Mean Difference (Final Values)|-1.56|||<|0.0215|2-Sided|95.0|-2.89|-0.24|||Mixed Models Analysis|||Statistical analysis at Week 24.|
1652781|NCT01668797|3040809|Superiority or Other||Mean Difference (Final Values)|-1.87|||<|0.008|2-Sided|95.0|-3.24|-0.5|||Mixed Models Analysis|||Statistical analysis at Week 12.|
1652782|NCT01668797|3040809|Superiority or Other||Mean Difference (Final Values)|-1.11|||<|0.0507|2-Sided|95.0|-2.23|0.0|||Mixed Models Analysis|||Statistical analysis at Week 6.|
1652783|NCT01668797|3040810|Superiority or Other||Mean Difference (Final Values)|-7.95||||0.0007|2-Sided|95.0|-12.5|-3.41|||ANCOVA|||Statistical analysis at Week 52.|
1652784|NCT01668797|3040810|Superiority or Other||Mean Difference (Final Values)|-8.02||||0.0005|2-Sided|95.0|-12.4|-3.59|||ANCOVA|||Statistical analysis at Week 36.|
1652785|NCT01668797|3040810|Superiority or Other||Mean Difference (Final Values)|-7.59||||0.0008|2-Sided|95.0|-12.0|-3.18|||ANCOVA|||Statistical analysis at Week 24.|
1652786|NCT01668797|3040810|Superiority or Other||Mean Difference (Final Values)|-5.05||||0.0174|2-Sided|95.0|-9.2|-0.9|||ANCOVA|||Statistical analysis at Week 12.|
1652787|NCT01668797|3040810|Superiority or Other||Mean Difference (Final Values)|-3.04||||0.0683|2-Sided|95.0|-6.31|0.23|||ANCOVA|||Statistical analysis at Week 6.|
1652788|NCT01668797|3040811|Superiority or Other||Mean Difference (Final Values)|-4.42||||0.0011|2-Sided|95.0|-7.01|-1.82|||Mixed Models Analysis|||Statistical analysis at across visits|
1652789|NCT01668797|3040811|Superiority or Other||Mean Difference (Final Values)|-6.31||||0.28|2-Sided|95.0|-18.1|5.46|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 52.|
1652790|NCT01668797|3040811|Superiority or Other||Mean Difference (Final Values)|-6.03||||0.0086|2-Sided|95.0|-10.5|-1.59|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 36.|
1652791|NCT01668797|3040811|Superiority or Other||Mean Difference (Final Values)|-4.77||||0.0226|2-Sided|95.0|-8.86|-0.68|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 24.|
1652792|NCT01668797|3040811|Superiority or Other||Mean Difference (Final Values)|-5.31||||0.0301|2-Sided|95.0|-10.1|-0.52|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 12.|
1652793|NCT01668797|3040811|Superiority or Other||Mean Difference (Final Values)|-3.3||||0.0664|2-Sided|95.0|-6.82|0.23|||Mixed Models Analysis|||Statistical analysis of treatment comparisons at Week 6.|
1652794|NCT01668797|3040812|Superiority or Other|||||||0.0007|||||||Chi-squared|||Statistical analysis at Last Visit.|
1652795|NCT01668797|3040812|Superiority or Other|||||||0.8734|||||||Chi-squared|||Statistical analysis at Week 52.|
1652796|NCT01668797|3040812|Superiority or Other|||||||0.1977|||||||Chi-squared|||Statistical analysis at Week 36.|
1652797|NCT01668797|3040812|Superiority or Other|||||||0.7354|||||||Chi-squared|||Statistical analysis at Week 24.|
1652798|NCT01668797|3040812|Superiority or Other|||||||0.2051|||||||Chi-squared|||Statistical analysis at Week 12.|
1652799|NCT01668797|3040812|Superiority or Other|||||||0.2296|||||||Chi-squared|||Statistical analysis at Week 6.|
1653187|NCT01662791|3041683|Superiority or Other|||||||1|||||||Chi-squared|||Comparison between the groups for >12 ppm.|
1652800|NCT01668797|3040813|Superiority or Other||||||<|0.0001|||||||Chi-squared|||The percentage of participants with impending relapse in treatment groups (Brexpiprazole and placebo) in final analysis for participants meeting at least one of the criteria.|
1652801|NCT01668797|3040814|Superiority or Other||||||<|0.0001|||||||Log Rank|The log-rank test was based on time to exacerbation of psychotic symptoms/impending relapse.||The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 1:1 (brexpiprazole:placebo) randomization ratio.|
1652802|NCT01668784|3040819|Superiority or Other (legacy)||Hazard Ratio (HR)|0.77|||||2-Sided|95.0|0.6|0.97|||||Hazard ratio is nivolumab over everolimus|Unstratified hazard ratio for participants with quantifiable PD-L1 expression level < 1 percent|
1652803|NCT01668784|3040819|Superiority or Other (legacy)||Hazard Ratio (HR)|0.79|||||2-Sided|95.0|0.53|1.17|||||Hazard ratio is nivolumab over everolimus|Unstratified hazard ratio for participants with quantifiable PD-L1 expression level >= 1 percent|
1652804|NCT01668784|3040820|Superiority or Other (legacy)||Hazard Ratio (HR)|0.88||||0.1135|2-Sided|95.0|0.75|1.03|||Log Rank|Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group, number of prior anti-angiogenic therapies, and the region.|Stratified Cox proportional hazard model. Hazard ratio is nivolumab over everolimus.||
1652805|NCT01668784|3040823|Superiority or Other (legacy)||Odds Ratio (OR)|5.98|||<|0.0001|2-Sided|95.0|3.68|9.72||Two-sided p-value from Cochran-Mantel-Haenszel test for the comparison of the odds ratio of Nivolumab over Everolimus.|Cochran-Mantel-Haenszel|CHM test stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group, number of prior anti-angiogenic therapies, and the region.|Ratio of Nivolumab over Everolimus||
1652806|NCT01668784|3040824|Superiority or Other (legacy)||Hazard Ratio (HR)|0.73||||0.0018|2-Sided|98.52|0.57|0.93||The boundary for statistical significance required the p-value to be less than 0.0148 at the interim analyses.|Log Rank|Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center risk group, number of prior anti-angiogenic therapies, and the region.|Stratified Cox proportional hazard model. Hazard ratio (HR) was Nivolumab over Everolimus.||
1652807|NCT01668667|3040825|Superiority or Other|||||||0.012||||||A significant p-value will indicate a nonzero linear effect across increasing levels of GEn dosage.|Cochran-Armitage trend test||||
1652808|NCT01668667|3040826|Superiority or Other|||||||0.072|||||||ANOVA|||Overall treatment effect|
1652809|NCT01668667|3040826|Superiority or Other|||||||0.022|||||||ANOVA|||For the mean change from Baseline for IRLS Rating Scale total score at the EOT, the linear contrast test based on an analysis of variance with treatment effect was used to detect linear dose-response trends across increasing levels of GEn dosage.|
1652810|NCT01668667|3040827|Superiority or Other||Odds Ratio (OR)|2.24||||0.005|2-Sided|95.0|1.27|3.94|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with “much improved” or “very much improved” on the investigator-rated CGI-I at the end of treatment.|
1652811|NCT01668667|3040827|Superiority or Other||Odds Ratio (OR)|2.15||||0.007|2-Sided|95.0|1.23|3.77|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with “much improved” or “very much improved” on the investigator-rated CGI-I at the end of treatment.|
1652812|NCT01668667|3040827|Superiority or Other||Odds Ratio (OR)|2.26||||0.004|2-Sided|95.0|1.3|3.95|||Regression, Logistic||The analysis method used was logistic regression with terms of pooled site and treatment.|The null hypothesis for this study is that there is no difference between GEn and placebo in the proportion of subjects who are responders with “much improved” or “very much improved” on the investigator-rated CGI-I at the end of treatment.|
1652813|NCT01668667|3040828|Superiority or Other||Adjusted mean difference|-1.55|Standard Error of the Mean|0.767||0.144|2-Sided|95.0|-3.63|0.53|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.|
1652814|NCT01668667|3040828|Superiority or Other||Adjusted mean difference|-2.61|Standard Error of the Mean|0.764||0.014|2-Sided|95.0|-4.68|-0.54|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.|
1652815|NCT01668667|3040828|Superiority or Other||Adjusted mean difference|-2.57|Standard Error of the Mean|0.745||0.014|2-Sided|95.0|-4.62|-0.52|||ANCOVA|No adjustment for multiplicity will be made for these analyses.|The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate.|The null hypothesis for this study is that there is no difference between GEn and placebo in the change from Baseline to the end of treatment in the IRLS Rating Scale total score. All comparisons will be made at the two-sided 0.05 level of significance.|
1652816|NCT01668628|3040867|Superiority or Other|||||||0.157|||||||t-test, 2 sided|||Student's t test: Comparison of baseline BDI score between Normohydration group and Overhydration group.|
1652817|NCT01668628|3040867|Superiority or Other|||||||0.008|||||||t-test, 2 sided|||Student's t test: Comparison of baseline kidney disease component score between Normohydration group and Overhydration group|
1652818|NCT01668628|3040867|Superiority or Other|||||||0.008|||||||t-test, 2 sided|||Student's t test: Comparison of baseline mental health score between Normohydration group and Overhydration group.|
1652819|NCT01668628|3040867|Superiority or Other|||||||0.008|||||||t-test, 2 sided|||Student's t-test: Comparison of baseline physical health score between Normohydration group and Overhydration group.|
1652820|NCT01668030|3040887|Superiority|||||||0.0853|||||||t-test, 2 sided||||
1653220|NCT01659866|3042085|Superiority||||||<|0.05|||||||Fisher Exact||||
1652821|NCT01668004|3040926|Superiority or Other||Treatment Ratio|4.5|||<|0.0001|2-Sided|95.0|3.86|5.25|||Generalized estimating equation|||Treatment difference (expressed as ratio) in uveitis incidence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=92.|
1652822|NCT01668004|3040927|Superiority or Other|||||||1|||||||McNemar|||Treatment comparison of uveitis occurrence rate assessed 1 year before initial anti-TNF/GLM treatment and 1 year after start of GLM treatment. Number of subjects included in analysis: N=93.|
1652823|NCT01667978|3040928|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1652824|NCT01667796|3040944|Superiority or Other|||||||0.008||||||Adjusted for adherence, body mass index, and oral contraceptive use|Generalized estimating equation||||
1652825|NCT01667796|3040944|Superiority or Other|||||||0.001|||||||univariate generalized estimating equati||||
1652826|NCT01667679|3040974|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.05||0.1704|2-Sided|95.0|-0.17|0.03|||ANCOVA||120 minutes post-dose||
1652827|NCT01667679|3040974|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.048||0.0189|2-Sided|95.0|-0.21|-0.02|||ANCOVA||90 minutes post-dose||
1652828|NCT01667679|3040974|Superiority or Other||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.047||0.0006|2-Sided|95.0|-0.26|-0.07|||ANCOVA||60 minutes post-dose||
1652829|NCT01667679|3040974|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.043||0.0001|2-Sided|95.0|-0.25|-0.08|||ANCOVA||45 minutes post-dose||
1652830|NCT01667679|3040974|Superiority or Other||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.035|<|0.0001|2-Sided|95.0|-0.23|-0.09|||ANCOVA||30 minutes post-dose||
1652831|NCT01667679|3040974|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.026|<|0.0003|2-Sided|95.0|-0.14|-0.04|||ANCOVA||15 minutes post-dose||
1652832|NCT01667679|3040974|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.019|<|0.0181|2-Sided|95.0|-0.08|-0.01|||ANCOVA||10 minutes post-dose||
1652833|NCT01667679|3040975|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.052||0.4031|2-Sided|95.0|-0.15|0.06|||ANCOVA||120 minutes post-dose||
1652834|NCT01667679|3040975|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.052||0.0333|2-Sided|95.0|-0.21|-0.01|||ANCOVA||90 minutes post-dose||
1652835|NCT01667679|3040975|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.048||0.004|2-Sided|95.0|-0.24|-0.05|||ANCOVA||60 minutes post-dose||
1652836|NCT01667679|3040975|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.046||0.0005|2-Sided|95.0|-0.26|-0.07|||ANCOVA||45 minutes post-dose||
1652837|NCT01667679|3040975|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.039|<|0.0001|2-Sided|95.0|-0.26|-0.11|||ANCOVA||30 minutes post-dose||
1652838|NCT01667679|3040975|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.029|<|0.0063|2-Sided|94.0|-0.14|-0.02|||ANCOVA||15 minutes post-dose||
1652839|NCT01667679|3040975|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.021|<|0.3562|2-Sided|95.0|-0.06|0.02|||ANCOVA||10 minutes post-dose||
1652840|NCT01667679|3040977|Superiority or Other||Odds Ratio (OR)|1.21||||0.2085|2-Sided|95.0|0.9|1.62|||ANCOVA||120 minutes post-dose||
1652841|NCT01667679|3040977|Superiority or Other||Odds Ratio (OR)|1.38||||0.0272|2-Sided|95.0|1.04|1.83|||ANCOVA||90 minutes post-dose||
1652842|NCT01667679|3040977|Superiority or Other||Odds Ratio (OR)|1.6||||0.0008|2-Sided|95.0|1.22|2.11|||ANCOVA||60 minutes post-dose||
1652843|NCT01667679|3040977|Superiority or Other||Odds Ratio (OR)|1.68||||0.0004|2-Sided|95.0|1.26|2.23|||ANCOVA||45 minutes post-dose||
1652844|NCT01667679|3040977|Superiority or Other||Odds Ratio (OR)|1.94|||<|0.0001|2-Sided|95.0|1.47|2.56|||ANCOVA||30 minutes post-dose||
1652845|NCT01667679|3040977|Superiority or Other||Odds Ratio (OR)|1.49|||<|0.0069|2-Sided|95.0|1.12|1.99|||ANCOVA||15 minutes post-dose||
1652846|NCT01667679|3040977|Superiority or Other||Odds Ratio (OR)|1.24|||<|0.2426|2-Sided|95.0|0.87|1.77|||ANCOVA||10 minutes post-dose||
1652847|NCT01667679|3040978|Superiority or Other||Odds Ratio (OR)|1.14||||0.2717|2-Sided|95.0|0.91|1.42|||ANCOVA||120 minutes post-dose||
1652848|NCT01667679|3040978|Superiority or Other||Odds Ratio (OR)|1.36||||0.0059|2-Sided|95.0|1.09|1.69|||ANCOVA||90 minutes post-dose||
1652849|NCT01667679|3040978|Superiority or Other||Odds Ratio (OR)|1.41||||0.0016|2-Sided|95.0|1.14|1.74|||ANCOVA||60 minutes post-dose||
1652850|NCT01667679|3040978|Superiority or Other||Odds Ratio (OR)|1.64|||<|0.0001|2-Sided|95.0|1.29|2.09|||ANCOVA||45 minutes post-dose||
1652851|NCT01667679|3040978|Superiority or Other||Odds Ratio (OR)|1.82|||<|0.0003|2-Sided|95.0|1.32|2.5|||ANCOVA||30 minutes post-dose||
1652852|NCT01667679|3040978|Superiority or Other||Odds Ratio (OR)|2.03|||<|0.0077|2-Sided|95.0|1.21|3.42|||ANCOVA||15 minutes post-dose||
1652853|NCT01667679|3040978|Superiority or Other||Odds Ratio (OR)|1.85|||<|0.1771|2-Sided|95.0|0.76|4.54|||ANCOVA||10 minutes post-dose||
1652854|NCT01667679|3040979|Superiority or Other||Odds Ratio (OR)|1.15||||0.2894|2-Sided|95.0|0.89|1.49|||ANCOVA||120 minutes post-dose||
1652855|NCT01667679|3040979|Superiority or Other||Odds Ratio (OR)|1.26||||0.0654|2-Sided|95.0|0.99|1.61|||ANCOVA||90 minutes post-dose||
1652856|NCT01667679|3040979|Superiority or Other||Odds Ratio (OR)|1.37||||0.0057|2-Sided|95.0|1.1|1.71|||ANCOVA||60 minutes post-dose||
1652857|NCT01667679|3040979|Superiority or Other||Odds Ratio (OR)|1.56||||0.0002|2-Sided|95.0|1.24|1.96|||ANCOVA||45 minutes post-dose||
1652858|NCT01667679|3040979|Superiority or Other||Odds Ratio (OR)|1.79|||<|0.0001|2-Sided|95.0|1.45|2.21|||ANCOVA||30 minutes post-dose||
1652859|NCT01667679|3040979|Superiority or Other||Odds Ratio (OR)|1.51|||<|0.0005|2-Sided|95.0|1.2|1.9|||ANCOVA||15 minutes post-dose||
1652860|NCT01667679|3040979|Superiority or Other||Odds Ratio (OR)|1.16|||<|0.3549|2-Sided|95.0|0.85|1.6|||ANCOVA||10 minutes post-dose||
1652861|NCT01667679|3040980|Superiority or Other||Mean Difference (Final Values)|3.76|Standard Error of the Mean|0.971||0.0002|2-Sided|95.0|1.84|5.68|||ANCOVA||moderate/severe attacks||
1652862|NCT01667679|3040980|Superiority or Other||Mean Difference (Final Values)|3.66|Standard Error of the Mean|1.105||0.0013|2-Sided|95.0|1.47|5.85|||ANCOVA||mild attacks||
1652863|NCT01667679|3040981|Superiority or Other||Mean Difference (Final Values)|3.39|Standard Error of the Mean|0.824|<|0.0001|2-Sided|95.0|1.76|5.01|||ANCOVA||||
1652864|NCT01667549|3040988|Other||||||<|0.05|||||||ANOVA|||General linear models were conducted on WLZ scores with time as the within-subjects factor and Group as the between-subjects factor to determine there were differences in growth of the infants over time. This was not done to test hypothesis but to monitor growth of infants during course of trial.|
1652865|NCT01667549|3040989|Other||||||<|0.02||||||Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P<0.02 were considered significant.|planned comparison|A Bonferroni adjustment was calculated and only planned comparison with P's<0.02 were considered significant.||Separate analyses of variance with a priori contrasts specified 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).|
1652866|NCT01667549|3040990|Other|Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).|||||<|0.02||||||Because three comparisons were made for each outcome measure, a Bonferroni adjustment was calculated and only planned comparison with P's<0.02 were considered significant.|planned comparison|a Bonferroni adjustment was calculated and only planned comparison with P's<0.02 were considered significant.||Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).|
1652867|NCT01667549|3040991|Other||||||<|0.02|||||||ANOVA|||Repeated measures ANOVAs were conducted on maternal gLMS ratings with type of juice and time as the within-subject factors and experimental group as the grouping factor|
1652868|NCT01667549|3040992|Other|Repeated Measures ANOVA were done with type of cereal as within-subjects and experimental group as grouping factors. When significant, planned comparisons were carried out. ANOVAs with a priori contrasts specified determined whether 1-month exposure differed from the no-exposure control (timing hypothesis). ANOVAs with a priori contrasts specified determined whether 1-month differed from 3-months exposure and whether these groups differed from no-exposure control (duration hypothesis).||||||0.02||||||Bonferroni adjustment was made and only planned pairwise comparisons with calculated p values of 0.02 or lower significant.|planned comparison|Bonferroni adjustment was calculated and only planned pair-wise comparisons with calculated p value 0.02 or lower were considered significant.||Separate analyses of variance with a priori contrasts specified were conducted: 1) to determine whether the 1-month exposure groups (1M0.5, 1M1.5, and 1M2.5) differed from the no-exposure control group to test the hypothesis that the timing of exposure affected acceptance; and 2) to determine whether 1 month of exposure differed from 3 months (1M0.5, 3M0.5 groups) and whether these groups differed from the no-exposure control group (duration hypothesis).|
1652869|NCT01667419|3041024|Superiority||Hazard Ratio (HR)|0.95||||0.8597|2-Sided|95.0|0.55|1.66|||Log Rank||||
1652870|NCT01667419|3041024|Superiority||Hazard Ratio (HR)|0.53||||0.0274|2-Sided|95.0|0.3|0.94|||Log Rank||||
1652871|NCT01667419|3041025|Superiority||Hazard Ratio (HR)|0.91||||0.6815|2-Sided|95.0|0.57|1.44|||Log Rank||||
1652872|NCT01667419|3041025|Superiority||Hazard Ratio (HR)|0.58||||0.0133|2-Sided|95.0|0.37|0.9|||Log Rank||||
1652873|NCT01667419|3041026|Superiority||Hazard Ratio (HR)|0.8||||0.2598|2-Sided|95.0|0.54|1.18|||Log Rank||||
1652874|NCT01667419|3041026|Superiority||Hazard Ratio (HR)|0.54||||0.001|2-Sided|95.0|0.37|0.78|||Log Rank||||
1652875|NCT01667224|3041032|Non-Inferiority or Equivalence|Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|
1652876|NCT01667224|3041033|Non-Inferiority or Equivalence|Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|
1652877|NCT01667224|3041034|Non-Inferiority or Equivalence|Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|
1652878|NCT01667224|3041035|Non-Inferiority or Equivalence|Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|||||<|0.05|||||||Mixed Models Analysis|||Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.|
1652879|NCT01667107|3041037|Superiority or Other||Spearman rank correlation coefficient|0.59||||0.057|||||||Spearman rank correlation|||Spearman rank correlation between concurrent BAL and serum posaconazole concentrations|
1652880|NCT01667107|3041037|Superiority or Other||Spearman rank correlation coefficient|0.53||||0.139|||||||Spearman rank correlation|||Spearman rank correlation between concurrent BAL and serum posaconazole concentrations|
1652997|NCT01664104|3041377|Superiority or Other|||||||0.5332|||||||t-test|P-value signifies the CRP at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus > 30 minutes).|||
1653320|NCT01656850|3042329|Superiority or Other|||||||0.7823|||||||Mixed Models Analysis||||
1652881|NCT01666444|3041094|Superiority or Other (legacy)||Hazard Ratio (HR)|1.21||||0.943|1-Sided|98.0||1.56||P-value is for a one-sided hypothesis test.|Log Rank|The logrank test is stratified for platinum-free interval (<= 6 months vs > 6 months), and performance status (0 vs 1).||The null hypothesis is that the hazards of first progression or death are equal for both treatment groups. The primary assessment was to use a stratified logrank test and the study was to be considered sufficiently mature when survival is mature for analysis. Type I error was to be set to 0.02 for a one-sided test and the power for detecting a 31% reduction in the hazard (hazard ratio=0.69) due to VTX-2337 was expected to be approximately 83%.|
1652882|NCT01666444|3041095|Superiority or Other (legacy)||Hazard Ratio (HR)|1.22||||0.923|1-Sided|92.0||1.48||P-value is for a one-sided hypothesis test.|Log Rank|The logrank test is stratified for platinum-free interval (<= 6 months vs > 6 months), and performance status (0 vs 1).|Treatment Hazard ratio for overall survival (PLD+VTX relative to PLD+placebo). Survival is measured from date of enrollment and randomization on the study until death from any cause, or date of last contact.|The null hypothesis is that the hazards of death are equal for both treatment groups. The primary assessment of this hypothesis was done with a stratified logrank test and the study was to be considered sufficiently mature to assess this hypothesis when at least 211 deaths had occurred among all individuals enrolled. Type I error was to be set to 0.08 for a one-sided test and the power for detecting a 30% reduction in the hazard (hazard ratio=0.70) due to VTX-2337 was 88.2%.|
1652883|NCT01666314|3041116|Superiority or Other||Odds Ratio (OR)|4.145||||0.0355|2-Sided|95.0|0.9895|18.7606|||Fisher Exact||Odds ratio >1 favors orteronel.||
1652884|NCT01666314|3041117|Superiority or Other|||||||0.1078|||||||Fisher Exact||||
1652885|NCT01666002|3041126|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1652886|NCT01666002|3041127|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1652887|NCT01665911|3041129|Superiority or Other|||||||0.0444||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA||||
1652888|NCT01665911|3041129|Superiority or Other|||||||0.0075||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA||||
1652889|NCT01665911|3041129|Superiority or Other|||||||0||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA||||
1652890|NCT01665911|3041129|Superiority or Other|||||||0.19||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA||||
1652891|NCT01665911|3041129|Superiority or Other|||||||0.0012||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA||||
1652892|NCT01665911|3041129|Superiority or Other|||||||0.14||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk|ANOVA||||
1652893|NCT01665911|3041129|Superiority or Other|||||||0||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA||||
1652894|NCT01665911|3041129|Superiority or Other|||||||0||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA||||
1652895|NCT01665911|3041129|Superiority or Other|||||||0||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA||||
1652896|NCT01665911|3041129|Superiority or Other|||||||0||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA||||
1652897|NCT01665911|3041130|Superiority or Other|||||||0.81||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA||||
1652898|NCT01665911|3041130|Superiority or Other|||||||0.0142||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA||||
1652899|NCT01665911|3041130|Superiority or Other|||||||0.0269||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA||||
1652900|NCT01665911|3041130|Superiority or Other|||||||0.18||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA||||
1652901|NCT01665911|3041130|Superiority or Other|||||||0.26||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA||||
1652902|NCT01665911|3041130|Superiority or Other|||||||0.24||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg Sodium Fluoride in 200 ml milk|ANOVA||||
1652903|NCT01665911|3041130|Superiority or Other|||||||0.0003||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA||||
1652904|NCT01665911|3041130|Superiority or Other|||||||0.0008||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA||||
1652905|NCT01665911|3041130|Superiority or Other|||||||0.17||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA||||
1652906|NCT01665911|3041130|Superiority or Other|||||||0.24||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA||||
1652907|NCT01665911|3041131|Superiority or Other|||||||0.54||||||3 mg sodium fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA||||
1652908|NCT01665911|3041131|Superiority or Other|||||||0.15||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA||||
1652909|NCT01665911|3041131|Superiority or Other|||||||0.0423||||||1.5 mg sodium fluoride in 200 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA||||
1652910|NCT01665911|3041131|Superiority or Other|||||||0.47||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 200 ml milk|ANOVA||||
1652911|NCT01665911|3041131|Superiority or Other|||||||0.18||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 3 mg sodium fluoride in 100 ml milk|ANOVA||||
1652912|NCT01665911|3041131|Superiority or Other|||||||0.45||||||1.5 mg Sodium Fluoride in 100 ml milk vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA||||
1652913|NCT01665911|3041131|Superiority or Other|||||||0.0092||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 200 ml milk|ANOVA||||
1652914|NCT01665911|3041131|Superiority or Other|||||||0.0017||||||Non-fluoridated milk, 200 ml vs. 3 mg sodium fluoride in 100 ml milk|ANOVA||||
1652915|NCT01665911|3041131|Superiority or Other|||||||0.19||||||Non-fluoridated milk, 200 ml vs. 1.5 mg sodium fluoride in 200 ml milk|ANOVA||||
1652998|NCT01664104|3041380|Superiority or Other|||||||0.1296|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using CDAI (remission versus no remission).|||
1652999|NCT01664104|3041380|Superiority or Other|||||||0.1617|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using SDAI (remission versus no remission).|||
1652916|NCT01665911|3041131|Superiority or Other|||||||0.049||||||Non-fluoridated milk, 200 ml vs. 1.5 mg Sodium Fluoride in 100 ml milk|ANOVA|||Based on prior studies using a variety of products in this model, the within-product standard deviation of %SMH recovery is estimated to be 13% and the correlation between products is expected to be approximately 0.5. With a sample size of 28 subjects in a 5-way crossover study, the study will have 80% power to detect a %SMH recovery difference of 8.6%, assuming two-sided tests each conducted at a 5% significance level.|
1652917|NCT01665872|3041133|Equivalence|Chi-square was used with a p-value of 0.05 to determine if the difference was statistically greater than 0.||||||0.2914|||||||Chi-squared||||
1652918|NCT01665872|3041134|Equivalence|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.0915||||||This test looks at a difference in PSI total score (percentile) at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)||||
1652919|NCT01665872|3041134|Equivalence|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.0404||||||This test looks at a difference in Difficult Child at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)||||
1652920|NCT01665872|3041134|Equivalence|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.3352||||||This test looks at a difference in Parent-Child Dysfunctional Interaction at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)||||
1652921|NCT01665872|3041134|Equivalence|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.092||||||This test looks at a difference in Parental Distress at the 12 month follow-up between groups.|Wilcoxon (Mann-Whitney)||||
1652922|NCT01665872|3041135|Equivalence|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.5337|||||||Wilcoxon (Mann-Whitney)|||Are CES-D scores at 12 months different between groups?|
1652923|NCT01665872|3041136|Equivalence|A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.||||||0.172|||||||t-test, 2 sided||||
1652924|NCT01665508|3041166|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Continuous variables were reported as the mean ± (SD) and categorical data presented as frequency and percentage of the sample. Comparisons between baseline and post-treatment SAQ scores, SF-36v2 scores, and CPET variables were performed using a paired t-test for normally distributed variables or a Wilcoxon signed-rank test for non-normally distributed variables. Normality was defined by the Shapiro-Wilk test. For categorical variables, data were compared using a chi-squared test.|
1652925|NCT01665157|3041209|Superiority or Other|||||||0.025|||||||Chi-squared||||
1652926|NCT01665157|3041210|Superiority or Other||||||<|0.01|||||||Chi-squared||||
1652927|NCT01665157|3041211|Superiority or Other||||||<|0.01|||||||Chi-squared||||
1652928|NCT01665157|3041214|Superiority or Other|||||||0.041|||||||Chi-squared||||
1652929|NCT01665157|3041214|Superiority or Other|||||||0.024|||||||Chi-squared|||"Null hypothesis: Low-residue diet package and 2L PEG vs. Self-controlled diet and 2L PEG provides same preparation quality."|
1652930|NCT01665157|3041214|Superiority or Other|||||||0.046|||||||Chi-squared||||
1652931|NCT01665157|3041215|Superiority or Other|||||||0.435||||||Not significant|ANOVA||||
1652932|NCT01665144|3041223|Superiority||Cox Proportional Hazard|0.79||||0.0134|2-Sided|95.0|0.65|0.95|||Cox proportional hazards model||||
1652933|NCT01664923|3041254|Superiority or Other||Difference in objective response rate|46.05|||<|0.0001|2-Sided|95.0|26.79|65.3||This secondary endpoint was not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Based on unstratified Cochran-Mantel-Haenszel mean score test.|||
1652934|NCT01664923|3041255|Superiority or Other||Hazard Ratio (HR)|0.91||||0.4945|2-Sided|95.0|0.695|1.192||This secondary endpoint was not adjusted for multiple comparisons.|Log Rank|P-value is based on a log-rank test stratified by disease stage at study entry.|Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with < 1 favoring enzalutamide.||
1652935|NCT01664923|3041256|Superiority or Other||Hazard Ratio (HR)|0.324|||<|0.0001|2-Sided|95.0|0.211|0.497|||Log Rank|P-value is based on an unstratified log-rank test.|Hazard ratio is based on an unstratified Cox-regression model (with treatment as the only covariate) and is relative to bicalutamide with < 1 favoring enzalutamide.||
1652936|NCT01664923|3041257|Superiority or Other||Difference in rates|50.0|||<|0.0001|2-Sided|95.0|41.4|58.5|||Cochran-Mantel-Haenszel|Comparison of the 2 treatment groups using the Cochran-Mantel-Haenszel mean score test stratified by disease stage at study entry.|Enzalutamide response rate minus bicalutamide response rate.||
1652937|NCT01664923|3041258|Superiority or Other||Hazard Ratio (HR)|0.19|||<|0.0001|2-Sided|95.0|0.137|0.264||P-value based on log-rank test stratified by disease stage at study entry as reported on the CRF.|Log Rank||Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with < 1 favoring enzalutamide.||
1652938|NCT01664923|3041259|Superiority or Other||Hazard Ratio (HR)|0.24|||<|0.0001|2-Sided|95.0|0.181|0.32||P-value based on log-rank test stratified by disease stage at study entry as reported on the case report form (CRF).|Log Rank||Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with < 1 favoring enzalutamide.||
1652939|NCT01664793|3041274|Superiority or Other||||||<|0.05|||||||Chi-squared|Chi-square tests for comparisons of between-arm changes in vaccination rates from pre to post intervention.|||
1652940|NCT01664624|3041283|Superiority or Other||LS Mean Difference|28.8|Standard Error of the Mean|5.76|<|0.001|2-Sided|95.0|17.1|40.5||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and Baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and roflumilast alone.|
1653123|NCT01663506|3041564|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 3|
1652941|NCT01664624|3041283|Superiority or Other||LS Mean Difference|22.7|Standard Error of the Mean|5.7|<|0.001|2-Sided|95.0|11.1|34.3||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and Baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and roflumilast alone.|
1652942|NCT01664624|3041283|Superiority or Other||LS Mean Difference|-5.1|Standard Error of the Mean|5.82|<|0.388|2-Sided|95.0|-16.9|6.7||The comparison was evaluated at the 5% level of significance.|ANCOVA|ANCOVA model with treatment as fixed effect, and baseline Postprandial AUC (0-8) of active GLP-1 as a continuous covariate.||ANCOVA was used to test the null hypothesis that the change from Baseline in the postprandial AUC(0-8) of active GLP-1 is no difference between the roflumilast + alogliptin and alogliptin alone.|
1652943|NCT01664559|3041284|Superiority or Other|||||||0.02|||||||Chi-squared|||Took acetaminophen prior to leaving the office|
1652944|NCT01664559|3041284|Superiority or Other|||||||1|||||||Chi-squared|||Major complications|
1652945|NCT01664559|3041284|Superiority or Other|||||||0.24|||||||Chi-squared|||Significant bleeding|
1652946|NCT01664559|3041284|Superiority or Other|||||||1|||||||Chi-squared, Corrected|||Able to complete the IUD insertion|
1652947|NCT01664559|3041284|Superiority or Other|||||||1|||||||Chi-squared|||Need for cervical dilation|
1652948|NCT01664559|3041284|Superiority or Other|||||||0.92|||||||Chi-squared|||Position of uterus (anteverted, retroverted, midpositioned)|
1652949|NCT01664559|3041284|Superiority or Other|||||||1|||||||Chi-squared|||Purpose of IUD (contraception or heavy menstrual bleeding)|
1652950|NCT01664559|3041284|Superiority or Other|||||||0.09|||||||Chi-squared|||IUD type (levonorgestrel or copper)|
1652951|NCT01664559|3041284|Superiority or Other|||||||0.2|||||||Chi-squared|||Level of training, PGY 1, 2, 3, 4 and Attending|
1652952|NCT01664559|3041285|Superiority or Other|||||||0.02|||||||Chi-squared|||Desires additional pain medication|
1652953|NCT01664559|3041285|Superiority or Other|||||||0.35|||||||Chi-squared|||Would recommend IUD placement to a friend|
1652954|NCT01664559|3041285|Superiority or Other|||||||0.76|||||||Chi-squared|||Satisfied or very satisfied with IUD placement procedure|
1652955|NCT01664559|3041285|Superiority or Other|||||||0.76|||||||Chi-squared|||Injection site pain (just as bad or worse than IUD procedure)|
1652956|NCT01664559|3041285|Superiority or Other||||||>|0.05|||||||Chi-squared|||Reported side effects (nausea, vomiting, dyspepsia, headache, dizziness, drowsiness, injection site itchiness, swelling or pain)|
1652957|NCT01664559|3041286|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||8) 15 min after placement|
1652958|NCT01664559|3041286|Superiority or Other|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||7) 5 min after placement|
1652959|NCT01664559|3041286|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||6) IUD placement|
1652960|NCT01664559|3041286|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||5) uterine sounding|
1652961|NCT01664559|3041286|Superiority or Other|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||4) tenaculum placement|
1652962|NCT01664559|3041286|Superiority or Other|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||3) speculum insertion|
1652963|NCT01664559|3041286|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|||2) pain with injection|
1652964|NCT01664559|3041286|Superiority or Other|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||1) anticipated pain|
1652965|NCT01664559|3041287|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||7) 15 min after placement|
1652966|NCT01664559|3041287|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||6) 5 min after placement|
1652967|NCT01664559|3041287|Superiority or Other||||||<|0.64|||||||Wilcoxon (Mann-Whitney)|||5) uterine sounding|
1652968|NCT01664559|3041287|Superiority or Other||||||<|0.36|||||||Wilcoxon (Mann-Whitney)|||4) tenaculum placement|
1652969|NCT01664559|3041287|Superiority or Other||||||<|0.72|||||||Wilcoxon (Mann-Whitney)|||3) speculum insertion|
1652970|NCT01664559|3041287|Superiority or Other||||||<|0.33|||||||Wilcoxon (Mann-Whitney)|||2) pain with injection|
1652971|NCT01664559|3041287|Superiority or Other||||||<|0.31|||||||Wilcoxon (Mann-Whitney)|||1) Anticipated pain|
1652972|NCT01664559|3041288|Superiority or Other|||||||0.99|||||||Wilcoxon (Mann-Whitney)||||
1652973|NCT01664247|3041300|Superiority or Other||Mean Difference (Final Values)|-2.5|||<|0.0001|2-Sided|95.0|-2.91|-2.09|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg – Placebo for the time point before breakfast the following day.|
1652974|NCT01664247|3041300|Superiority or Other||Mean Difference (Final Values)|-1.75|||<|0.0001|2-Sided|95.0|-2.27|-1.23|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg – Placebo for the time point before bedtime.|
1652975|NCT01664247|3041300|Superiority or Other||Mean Difference (Final Values)|-1.72|||<|0.0001|2-Sided|95.0|-2.26|-1.18|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg – Placebo for the time point 90 mins after main evening meal.|
1653221|NCT01659736|3042092|Superiority or Other|||||||0.006||||||p-value is for the condition (active TMS versus Sham) by time (pre, post, 3-month follow-up) interaction|ANOVA||||
1652976|NCT01664247|3041300|Superiority or Other||Mean Difference (Final Values)|-1.74|||<|0.0001|2-Sided|95.0|-2.25|-1.23|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg – Placebo for the time point main evening meal.|
1652977|NCT01664247|3041300|Superiority or Other||Median Difference (Final Values)|-1.93|||<|0.0001|2-Sided|95.0|-2.46|-1.4|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg – Placebo for the time point 90 mins after start of lunch.|
1652978|NCT01664247|3041300|Superiority or Other||Mean Difference (Final Values)|-2.01|||<|0.0001|2-Sided|95.0|-2.47|-1.56|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg – Placebo for the time point before lunch.|
1652979|NCT01664247|3041300|Superiority or Other||Mean Difference (Final Values)|-2.09|||<|0.0001|2-Sided|95.0|-2.71|-1.48|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo.|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg – Placebo for the time point 90 mins after breakfast.|
1652980|NCT01664247|3041300|Superiority or Other||Mean Difference (Final Values)|-2.69|||<|0.0001|2-Sided|95.0|-3.04|-2.34|||Mixed Models Analysis||The treatment contrast estimated was IDeg - Placebo|The 8-point profile (SMPG) values after 26 weeks of treatment were analysed jointly using a linear mixed model with an un-structured residual covariance structure and with treatment, time-point and an interaction between treatment and time-point, region and sex as fixed effects, and age and baseline response per time-point as covariates. Missing data was imputed using LOCF. The treatment contrast estimated was IDeg – Placebo for the time point before breakfast.|
1652981|NCT01664247|3041301|Superiority or Other||Mean Difference (Final Values)|-2.34|||<|0.0001|2-Sided|95.0|-2.67|-2.01|||ANOVA||The treatment contrast estimated was IDeg - Placebo.|The pre-breakfast measures of SMPG values after 26 weeks of treatment were analysed an ANOVA method with treatment, region and sex as fixed effects, and age and baseline response as covariates.|
1652982|NCT01664104|3041369|Superiority or Other|||||||0.6482|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.|||
1652983|NCT01664104|3041369|Superiority or Other|||||||0.9909|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus VAS fatigue at Month 6.|||
1652984|NCT01664104|3041370|Superiority or Other|||||||0.0151|||||||Spearman Correlation|P-value obtained from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6|||
1652985|NCT01664104|3041370|Superiority or Other|||||||0.0123|||||||Pearson correlation|P-value obtained from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in morning stiffness at Month 6.|||
1652986|NCT01664104|3041371|Superiority or Other|||||||0.3977|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.|||
1652987|NCT01664104|3041371|Superiority or Other|||||||0.5655|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between BMI at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.|||
1652988|NCT01664104|3041372|Superiority or Other|||||||0.0013|||||||Spearman Correlation|P-value calculated from Spearman correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.|||
1652989|NCT01664104|3041372|Superiority or Other|||||||0.0011|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between change from baseline in CRP versus change from baseline in VAS fatigue at Month 6.|||
1652990|NCT01664104|3041373|Superiority or Other|||||||0.325|||||||S|P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.|||
1652991|NCT01664104|3041373|Superiority or Other|||||||0.4854|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus VAS fatigue at Month 6.|||
1652992|NCT01664104|3041374|Superiority or Other|||||||0.0749|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.|||
1652993|NCT01664104|3041374|Superiority or Other|||||||0.0306|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient for change from baseline in CRP versus change from baseline in HAQ-DI (0-3) at Month 6.|||
1652994|NCT01664104|3041375|Superiority or Other|||||||0.8033|||||||Spearman Correlation|P-value was calculated from Spearman correlation coefficient between CRP at the start of TCZ treatment versus HAQ-D1 (0-3) at Month 6.|||
1652995|NCT01664104|3041375|Superiority or Other|||||||0.237|||||||Pearson correlation|P-value was calculated from Pearson correlation coefficient between CRP at the start of TCZ treatment versus HAQ-DI (0-3) at Month 6.|||
1652996|NCT01664104|3041376|Superiority or Other|||||||0.6159|||||||t-test|P-value signifies the BMI at the start of TCZ treatment using the morning stiffness ( ≤ 30 minutes versus > 30 minutes).|||
1653321|NCT01656850|3042330|Superiority or Other|||||||0.1101|||||||Mixed Models Analysis||||
1653000|NCT01664104|3041380|Superiority or Other|||||||0.0018|||||||t-test|P-value signifies the BMI at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).|||
1653001|NCT01664104|3041381|Superiority or Other|||||||0.6146|||||||t-test|P-value signifies the CRP at the start of TCZ treatment by remission status using CDAI (remission versus no remission).|||
1653002|NCT01664104|3041381|Superiority or Other|||||||0.6032|||||||t-test|P-value signifies the CRP at the start of TCZ treatment by remission status using SDAI (remission versus no remission).|||
1653003|NCT01664104|3041381|Superiority or Other|||||||0.6904|||||||t-test|P-value signifies CRP at the start of TCZ treatment by remission status using DAS28-CRP (remission versus no remission).|||
1653004|NCT01664104|3041382|Superiority or Other||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test||||
1653005|NCT01664104|3041382|Superiority or Other||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test||||
1653006|NCT01664104|3041383|Superiority or Other||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test||||
1653007|NCT01664104|3041383|Superiority or Other||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test||||
1653008|NCT01664104|3041403|Superiority or Other||||||<|0.0001|||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 6.|||
1653009|NCT01664104|3041403|Superiority or Other||||||<|0.0001|||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 3.|||
1653010|NCT01664104|3041404|Superiority or Other||||||<|0.0001|||||||Wilcoxon test|P-value was calculated between baseline versus change at Month 6.|||
1653011|NCT01664104|3041404|Superiority or Other||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test||||
1653012|NCT01664104|3041405|Superiority or Other||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 6.|Wilcoxon test||||
1653013|NCT01664104|3041405|Superiority or Other||||||<|0.0001||||||P-value was calculated between baseline versus change at Month 3.|Wilcoxon test||||
1653014|NCT01663857|3041467|Superiority|||||||0.4686|||||||Log Rank||||
1653015|NCT01663857|3041469|Superiority|||||||0.4|||||||Log Rank||||
1653016|NCT01663779|3041471|Superiority or Other||Odds Ratio (OR)|5.0|||<|0.01|2-Sided|95.0|3.0|7.0|||Chi-squared||||
1653017|NCT01663740|3041472|Superiority or Other||Difference in Percentage|-9.9|||||2-Sided|95.0|-47.2|27.9|||||Improvement from EOT to end of FU||
1653018|NCT01663740|3041473|Superiority or Other||Difference in Percentage|10.0|||||2-Sided|95.0|-29.7|47.7|||||Improvement from Baseline to end of FU||
1653019|NCT01663740|3041473|Superiority or Other||Difference in Percentage|-31.0|||||2-Sided|95.0|-59.7|2.7|||||Improvement from Baseline to EOT||
1653020|NCT01663740|3041474|Superiority or Other||Difference in Percentage|-11.8|||||2-Sided|95.0|-50.0|29.3|||||Improvement from EOT to end of FU||
1653021|NCT01663740|3041475|Superiority or Other||Difference in Percentage|6.7|||||2-Sided|95.0|-31.1|44.4|||||Improvement from Baseline to end of FU||
1653022|NCT01663740|3041475|Superiority or Other||Difference in Percentage|1.3|||||2-Sided|95.0|-31.3|33.7|||||Improvement from Baseline to EOT||
1653023|NCT01663740|3041476|Superiority or Other||Difference in Percentage|4.1|||||2-Sided|95.0|-34.5|42.5|||||Change in abnormal to abnormal sperm density from EOT to end of FU||
1653024|NCT01663740|3041477|Superiority or Other||Difference in Percentage|17.9|||||2-Sided|95.0|-15.3|48.8|||||Change in normal to abnormal sperm density from Baseline to EOT||
1653025|NCT01663740|3041477|Superiority or Other||Difference in Percentage|5.0|||||2-Sided|95.0|-34.3|43.3|||||Change in abnormal to abnormal sperm density from Baseline to end of FU||
1653026|NCT01663740|3041477|Superiority or Other||Difference in Percentage|14.3|||||2-Sided|95.0|-19.3|45.3|||||Change in abnormal to abnormal sperm density from Baseline to EOT||
1653027|NCT01663740|3041478|Superiority or Other||Mean Difference|25.881|Standard Error of the Mean|22.1348||0.2548|2-Sided|95.0|-20.024|71.786|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables|Change in inhibin B level from EOT to end of FU||
1653028|NCT01663740|3041479|Superiority or Other||Mean Difference|40.682|Standard Error of the Mean|17.6084||0.0279|2-Sided|95.0|4.72|76.643|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.|Change in inhibin B level from Baseline to end of FU||
1653029|NCT01663740|3041479|Superiority or Other||Mean Difference|8.142|Standard Error of the Mean|11.9301||0.5002|2-Sided|95.0|-16.223|32.506|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.|Change in inhibin B level from Baseline to EOT||
1653030|NCT01663740|3041480|Superiority or Other||Mean Difference|8.74|Standard Error of the Mean|17.0805||0.6134|2-Sided|95.0|-26.438|43.917|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from EOT to end of FU||
1653031|NCT01663740|3041481|Superiority or Other||Mean Difference|15.272|Standard Error of the Mean|20.6031||0.4636|2-Sided|95.0|-26.599|57.142|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from Baseline to end of FU||
1653032|NCT01663740|3041481|Superiority or Other||Mean Difference|-0.104|Standard Error of the Mean|23.466||0.9965|2-Sided|95.0|-47.792|47.585|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.|Change in prolactin level from Baseline to EOT||
1653033|NCT01663740|3041482|Superiority or Other||Mean Difference|-1.474|Standard Error of the Mean|0.8084||0.0798|2-Sided|95.0|-3.136|0.188|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from EOT to end of FU||
1653222|NCT01659021|3042119|Other||Hazard Ratio (HR)|0.3|||||2-Sided|95.0|0.17|0.51|||||Hazard ratio and 95% CIs were calculated using the Cox proportional hazards model without any adjustments.||
1653034|NCT01663740|3041483|Superiority or Other||Mean Difference|-0.983|Standard Error of the Mean|0.6739||0.1539|2-Sided|95.0|-2.352|0.387|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from Baseline to end of FU||
1653035|NCT01663740|3041483|Superiority or Other||Mean Difference|2.541|Standard Error of the Mean|1.7274||0.1505|2-Sided|95.0|-0.969|6.052|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in FSH level from Baseline to EOT||
1653036|NCT01663740|3041484|Superiority or Other||Mean Difference|-1.065|Standard Error of the Mean|0.4057||0.0143|2-Sided|95.0|-1.899|-0.231|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,& pre-transplant dialysis duration as explanatory variables.|Change in LH level from EOT to end of FU||
1653037|NCT01663740|3041485|Superiority or Other||Mean Difference|-1.215|Standard Error of the Mean|0.4477||0.0104|2-Sided|95.0|-2.125|-0.305|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in LH level from Baseline to end of FU||
1653038|NCT01663740|3041485|Superiority or Other||Mean Difference|0.076|Standard Error of the Mean|0.6347||0.9053|2-Sided|95.0|-1.214|1.366|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.|Change in LH level from Baseline to EOT||
1653039|NCT01663740|3041486|Superiority or Other||Mean Difference|0.047|Standard Error of the Mean|1.51||0.9753|2-Sided|95.0|-3.063|3.157|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from EOT to end of FU||
1653040|NCT01663740|3041487|Superiority or Other||Mean Difference|-1.114|Standard Error of the Mean|1.6147||0.4949|2-Sided|95.0|-4.392|2.164|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from Baseline to end of FU||
1653041|NCT01663740|3041487|Superiority or Other||Mean Difference|-1.861|Standard Error of the Mean|1.6512||0.2673|2-Sided|95.0|-5.213|1.491|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.|Change in total testosterone level from Baseline to EOT||
1653042|NCT01663740|3041488|Superiority or Other||Mean Difference|-2.95|Standard Error of the Mean|7.7598||0.708|2-Sided|95.0|-19.192|13.291|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from EOT to end of FU||
1653043|NCT01663740|3041489|Superiority or Other||Mean Difference|-1.854|Standard Error of the Mean|5.1817||0.7229|2-Sided|95.0|-12.423|8.714|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from Baseline to end of FU||
1653044|NCT01663740|3041489|Superiority or Other||Mean Difference|-5.741|Standard Error of the Mean|6.7578||0.4021|2-Sided|95.0|-19.524|8.042|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.|Change in sperm morphology from Baseline to EOT||
1653045|NCT01663740|3041490|Superiority or Other||Mean Difference|-11.683|Standard Error of the Mean|12.2576||0.3505|2-Sided|95.0|-37.039|13.674|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from EOT to end of FU||
1653046|NCT01663740|3041491|Superiority or Other||Mean Difference|-9.802|Standard Error of the Mean|8.3702||0.2495|2-Sided|95.0|-26.795|7.19|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from Baseline to end of FU||
1653047|NCT01663740|3041491|Superiority or Other||Mean Difference|-21.828|Standard Error of the Mean|9.1214||0.0222|2-Sided|95.0|-40.346|-3.311|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.|Change in total motility of sperm from Baseline to EOT||
1653048|NCT01663740|3041492|Superiority or Other||Mean Difference|-10.195|Standard Error of the Mean|19.5745||0.6058|2-Sided|95.0|-49.934|29.543|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from Baseline to end of FU||
1653049|NCT01663740|3041493|Superiority or Other||Mean Difference|51.267|Standard Error of the Mean|36.6869||0.1756|2-Sided|95.0|-24.626|127.159|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from EOT to end of FU||
1653050|NCT01663740|3041494|Superiority or Other||Mean Difference|-0.128|Standard Error of the Mean|0.3684||0.7323|2-Sided|95.0|-0.888|0.633|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from EOT to end of FU||
1653051|NCT01663740|3041495|Superiority or Other||Mean Difference|-0.128|Standard Error of the Mean|0.3343||0.7046|2-Sided|95.0|-0.806|0.551|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from Baseline to end of FU||
1653052|NCT01663740|3041495|Superiority or Other||Mean Difference|0.155|Standard Error of the Mean|0.3687||0.6773|2-Sided|95.0|-0.594|0.903|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,& duration of pre-transplant dialysis as explanatory variables.|Change in seminal volume from Basline to EOT||
1653053|NCT01663740|3041496|Superiority or Other||Mean Difference|2.869|Standard Error of the Mean|3.2934||0.394|2-Sided|95.0|-4.001|9.739|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from EOT to end of FU||
1653054|NCT01663740|3041497|Superiority or Other||Mean Difference|-1.051|Standard Error of the Mean|3.2058||0.7449|2-Sided|95.0|-7.566|5.464|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from Baseline to end of FU||
1653055|NCT01663740|3041497|Superiority or Other||Mean Difference|1.758|Standard Error of the Mean|2.646||0.5109|2-Sided|95.0|-3.619|7.135|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,& duration of pre-transplant dialysis as explanatory variables.|Change in TUNEL score from Baseline to EOT||
1653056|NCT01663740|3041498|Superiority or Other||Mean Difference|-40.166|Standard Error of the Mean|14.1387||0.0075|2-Sided|95.0|-68.869|-11.463|||Mixed Models Analysis|Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,& duration of pre-transplant dialysis as explanatory variables.|Change in sperm density from Baseline to EOT||
1653057|NCT01663727|3041501|Superiority or Other||Hazard Ratio (HR)|0.74||||0.2429|2-Sided|95.0|0.45|1.22|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.|
1653058|NCT01663727|3041501|Superiority or Other||Hazard Ratio (HR)|0.7||||0.1783|2-Sided|95.0|0.41|1.18|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).|
1653059|NCT01663727|3041502|Superiority or Other||Hazard Ratio (HR)|0.82||||0.2959|2-Sided|95.0|0.56|1.19|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.|
1653060|NCT01663727|3041502|Superiority or Other||Hazard Ratio (HR)|0.8||||0.2737|2-Sided|95.0|0.54|1.19|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).|
1653061|NCT01663727|3041503|Superiority or Other||Difference in Response Rates|21.53||||0.0017|2-Sided|95.0|8.73|34.32|||Fisher||||
1653062|NCT01663727|3041504|Superiority or Other||Hazard Ratio (HR)|0.68||||0.0101|2-Sided|96.0|0.5|0.93|||Log Rank|||Unstratified analysis.|
1653063|NCT01663727|3041504|Superiority or Other||Hazard Ratio (HR)|0.64||||0.0038|2-Sided|96.0|0.47|0.88|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).|
1653064|NCT01663727|3041506|Superiority or Other||Difference in Response Rates|20.78|||<|0.0001|2-Sided|95.0|11.45|30.11|||Fisher||||
1653065|NCT01663727|3041507|Superiority or Other||Hazard Ratio (HR)|0.87||||0.3616|2-Sided|95.0|0.65|1.17|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.|
1653066|NCT01663727|3041507|Superiority or Other||Hazard Ratio (HR)|0.85||||0.2745|2-Sided|95.0|0.63|1.14|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).|
1653067|NCT01663727|3041509|Superiority or Other||Hazard Ratio (HR)|0.97||||0.8004|2-Sided|95.0|0.78|1.21|||Log Rank||Hazards ratio was estimated by Cox regression.|Unstratified analysis.|
1653068|NCT01663727|3041509|Superiority or Other||Hazard Ratio (HR)|0.94||||0.5877|2-Sided|95.0|0.75|1.18|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).|
1653069|NCT01663727|3041511|Superiority or Other|||||||0.4619|||||||Wald Test|||A stratified multivariate Cox regression model, including treatment, VEGF-A level, and interaction between treatment and VEGF-A level (low, high) as factors was used to estimate the interaction p-value of the treatment with VEGF-A level for PFS. Analysis for the interaction of treatment effect with the plasma VEGF-A levels was a secondary objective.|
1653070|NCT01663727|3041511|Superiority or Other||Hazard Ratio (HR)|0.73||||0.0046|2-Sided|99.0|0.55|0.97|||Log Rank|||Unstratified Analysis.|
1653071|NCT01663727|3041511|Superiority or Other||Hazard Ratio (HR)|0.68||||0.0007|2-Sided|99.0|0.51|0.91|||Log Rank||Hazards ratio was estimated by Cox regression.|Stratified analysis: Stratification factors were plasma VEGF-A level (low/high), prior adjuvant chemotherapy (yes/no) and estrogen receptor / progesterone receptor status (positive, negative).|
1653072|NCT01663714|3041533|Superiority or Other||percentage of participants|100.0|||||2-Sided|95.0|100.0|100.0|||||The estimated value represents the percentage of participants with confirmed response.||
1653073|NCT01663714|3041534|Superiority or Other||percentage of participants|100.0|||||2-Sided|95.0|100.0|100.0|||||The estimated value represents the percentage of participants with unconfirmed response.||
1653074|NCT01663623|3041537|Other||Hazard Ratio (HR)|1.07||||0.884|2-Sided|95.0|0.44|2.59||Cox proportional Hazards (Wald Chi Square)|Cox Proportional Hazards model|Analysis was adjusted for ANCA type, disease stage at induction and induction regimen|Analysis performed using a Cox Proportional Hazards model with covariates treatment group, Actual ANCA type, Actual disease stage at induction and Actual induction regimen.||
1653075|NCT01663532|3041538|Superiority or Other||Mean Difference (Final Values)|22.7|||<|0.0001|2-Sided|95.0|12.9|32.4|||Cochran-Mantel-Haenszel|CMH test controlling by region (pooled sites).||Statistical analysis for Week 10. LOCF method were used in imputation of missing data.|
1653076|NCT01663532|3041539|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|CMH raw mean scores differ test (Van Elteren test) controlling for pooled centers.||Statistical analysis for Week 10. LOCF method were used in imputation of missing data.|
1653077|NCT01663532|3041540|Superiority or Other||Mean Difference (Final Values)|7.1|||<|0.0001|2-Sided|95.0|4.1|10.1|||ANCOVA|ANCOVA model with treatment and pooled centers as factors and Baseline value as covariate for the comparison at other visits.|Difference in least square mean of change were derived from ANCOVA model.|Statistical analysis for Week 10.|
1653124|NCT01663402|3041580|Superiority||Hazard Ratio (HR)|0.92||||0.3824|2-Sided|95.0|0.76|1.11||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|
1653078|NCT01663532|3041541|Superiority or Other||Mean Difference (Final Values)|-2.8|||<|0.0001|2-Sided|95.0|-4.1|-1.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653079|NCT01663532|3041541|Superiority or Other||Mean Difference (Final Values)|-2.6|||<|0.0001|2-Sided|95.0|-3.7|-1.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653080|NCT01663532|3041541|Superiority or Other||Mean Difference (Final Values)|-2.2|||<|0.0001|2-Sided|95.0|-3.2|-1.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653081|NCT01663532|3041541|Superiority or Other||Mean Difference (Final Values)|-1.8|||<|0.0003|2-Sided|95.0|-2.7|-0.8|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653082|NCT01663532|3041541|Superiority or Other||Mean Difference (Final Values)|-1.2|||<|0.0032|2-Sided|95.0|-2.0|-0.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653083|NCT01663532|3041541|Superiority or Other||Mean Difference (Final Values)|-0.9|||<|0.0023|2-Sided|95.0|-1.6|-0.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653084|NCT01663532|3041542|Superiority or Other||Mean Difference (Final Values)|-5.1|||<|0.0001|2-Sided|95.0|-6.4|-3.7|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653085|NCT01663532|3041542|Superiority or Other||Mean Difference (Final Values)|-4.8|||<|0.0001|2-Sided|95.0|-6.2|-3.4|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653086|NCT01663532|3041542|Superiority or Other||Mean Difference (Final Values)|-3.8|||<|0.0001|2-Sided|95.0|-5.1|-2.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653087|NCT01663532|3041542|Superiority or Other||Mean Difference (Final Values)|-3.1|||<|0.0001|2-Sided|95.0|-4.3|-2.0|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653088|NCT01663532|3041542|Superiority or Other||Mean Difference (Final Values)|-2.3|||<|0.0001|2-Sided|95.0|-3.3|-1.3|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653089|NCT01663532|3041542|Superiority or Other||Mean Difference (Final Values)|-1.4|||<|0.0006|2-Sided|95.0|-2.1|-0.6|||Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653143|NCT01662960|3041653|Superiority|Test for the superiority of Mirror therapy over Divider therapy.|Slope|-0.002||||0.93|2-Sided|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA||||
1653090|NCT01663532|3041543|Superiority or Other||Mean Difference (Final Values)|-0.8|||<|0.0001|2-Sided|95.0|-1.1|-0.6||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653091|NCT01663532|3041543|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.0001|2-Sided|95.0|-0.9|-0.5||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653092|NCT01663532|3041543|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.0001|2-Sided|95.0|-0.9|-0.5||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653093|NCT01663532|3041543|Superiority or Other||Mean Difference (Final Values)|-0.6|||<|0.0001|2-Sided|95.0|-0.7|-0.4||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653094|NCT01663532|3041543|Superiority or Other||Mean Difference (Final Values)|-0.4|||<|0.0001|2-Sided|95.0|-0.6|-0.2||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653095|NCT01663532|3041543|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.0001|2-Sided|95.0|-0.4|-0.1||After the comparison for primary efficacy endpoint was statistically significant, the comparison of change from Baseline in CGI severity score was conducted at same alpha level 0.05.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested.|
1653096|NCT01663532|3041544|Superiority or Other||Mean Difference (Final Values)|-15.1|||<|0.0001|2-Sided|95.0|-19.4|-10.8||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 10.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.|
1653097|NCT01663532|3041544|Superiority or Other||Mean Difference (Final Values)|-14.0|||<|0.0001|2-Sided|95.0|-18.4|-9.6||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 8.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.|
1653125|NCT01663402|3041581|Superiority||Hazard Ratio (HR)|0.86||||0.0003|2-Sided|95.0|0.79|0.93||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|
1653144|NCT01662960|3041654|Superiority|Test for the superiority of Mirror therapy over Divider therapy.|Slope|0.4||||0.8|2-Sided|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA||||
1653098|NCT01663532|3041544|Superiority or Other||Mean Difference (Final Values)|-11.1|||<|0.0001|2-Sided|95.0|-15.0|-7.3||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 6.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.|
1653099|NCT01663532|3041544|Superiority or Other||Mean Difference (Final Values)|-9.2|||<|0.0001|2-Sided|95.0|-12.8|-5.6||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at week 4.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.|
1653100|NCT01663532|3041544|Superiority or Other||Mean Difference (Final Values)|-7.0|||<|0.0001|2-Sided|95.0|-10.0|-4.0||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 2.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.|
1653101|NCT01663532|3041544|Superiority or Other||Mean Difference (Final Values)|-3.9|||<|0.0005|2-Sided|95.0|-6.1|-1.7||Kenward-Rodger degree of freedom was used to test the treatment effects and p-value was not adjusted as this is a primary efficacy endpoint.|Mixed Models Analysis|MMRM analysis with treatment, pooled centers, Week and treatment-by-Week, and Baseline-by-Week interaction as an unstructured covariate was performed.|Difference in Least Square (LS) mean of change and 95% Confidence interval were derived from pair-wise comparison within MMRM at Week 1.|Null hypothesis of change from Baseline in PANSS total score of aripiprazole IM depot 400/300mg group is same as that of placebo group was tested. The sample size estimated a 1:1 randomization ratio (aripiprazole IM depot 400/300mg: placebo) to achieve 90% power and to preserve a nominal alpha level of 0.05 given a treatment difference of -7.5 points in change from Baseline with standard deviation of 20 points between aripiprazole and placebo using a two-sided z-test.|
1653102|NCT01663506|3041551|Superiority or Other (legacy)||||||<|0.001|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12|
1653103|NCT01663506|3041551|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6|
1653104|NCT01663506|3041552|Superiority or Other (legacy)||||||<|0.001|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12|
1653105|NCT01663506|3041552|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6|
1653106|NCT01663506|3041553|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon's signed-rank test|||TJC28: Change from Baseline at Month 12|
1653107|NCT01663506|3041553|Superiority or Other (legacy)||||||<|0.001|||||||Wilcoxon's signed-rank test|||SJC28: Change from Baseline at Month 12|
1653108|NCT01663506|3041553|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon's signed-rank test|||TJC28: Change from Baseline at Month 6|
1653109|NCT01663506|3041553|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon's signed-rank test|||SJC28: Change from Baseline at Month 6|
1653110|NCT01663506|3041555|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12|
1653111|NCT01663506|3041555|Superiority or Other (legacy)||||||<|0.05|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6|
1653112|NCT01663506|3041556|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12|
1653113|NCT01663506|3041556|Superiority or Other (legacy)||||||<|0.001|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6|
1653114|NCT01663506|3041558|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12|
1653115|NCT01663506|3041559|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12|
1653116|NCT01663506|3041559|Superiority or Other (legacy)||||||<|0.05|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6|
1653117|NCT01663506|3041561|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12|
1653118|NCT01663506|3041561|Superiority or Other (legacy)||||||<|0.05|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6|
1653119|NCT01663506|3041562|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12|
1653120|NCT01663506|3041562|Superiority or Other (legacy)||||||<|0.001|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6|
1653121|NCT01663506|3041564|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 12|
1653122|NCT01663506|3041564|Superiority or Other (legacy)||||||<|0.01|||||||Wilcoxon's signed-rank test|||Change from Baseline at Month 6|
1653126|NCT01663402|3041582|Superiority||Hazard Ratio (HR)|0.87||||0.0003|2-Sided|95.0|0.81|0.94||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|
1653127|NCT01663402|3041583|Superiority||Hazard Ratio (HR)|0.88||||0.006|2-Sided|95.0|0.8|0.96||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).|
1653128|NCT01663402|3041584|Superiority||Hazard Ratio (HR)|0.88||||0.0013|2-Sided|95.0|0.81|0.95||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region(North America,South America,Western Europe,Eastern Europe,Asia, Rest of the world).A hierarchical testing approach was used to control the overall type-I error at 0.0249 one-sided alpha level(0.0498 two-sided).Testing was then performed sequentially in the order endpoints were reported.Hierarchical testing sequence continued only if the previous endpoint was statistically significant.|
1653129|NCT01663402|3041585|Superiority||Hazard Ratio (HR)|0.85||||0.0003|2-Sided|95.0|0.78|0.93||Threshold for statistical significance at 0.0498 level.|Log Rank|||Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world).|
1653130|NCT01662999|3041622|Superiority or Other||Ratio of adjusted geometric mean|1.046|||||2-Sided|90.0|1.029|1.064||||||This analysis assesses the effect of concomitant administration of dapagliflozin on the AUC(0-T) of saxagliptin total active moiety. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.|
1653131|NCT01662999|3041623|Superiority or Other||Ratio of adjusted geometric mean|0.994|||||2-Sided|90.0|0.96|1.03||||||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin total active moiety. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.|
1653132|NCT01662999|3041624|Superiority or Other||ratio of adjusted geometric mean|1.085|||||2-Sided|90.0|1.058|1.113||||||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.|
1653133|NCT01662999|3041625|Superiority or Other||Ratio of adjusted geometric mean|1.085|||||2-Sided|90.0|1.058|1.113||||||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.|
1653134|NCT01662999|3041626|Superiority or Other||Ratio of adjusted geometric mean|0.991|||||2-Sided|90.0|0.961|1.022||||||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.|
1653135|NCT01662999|3041627|Superiority or Other||Ratio of adjusted geometric mean|0.991|||||2-Sided|90.0|0.96|1.022||||||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.|
1653136|NCT01662999|3041628|Superiority or Other||Ratio of adjusted geometric mean|1.055|||||2-Sided|90.0|1.004|1.109||||||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of 5-OH saxagliptin (metabolite of saxagliptin). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.|
1653137|NCT01662999|3041630|Superiority or Other||Ratio of adjusted geometric mean|0.927|||||2-Sided|90.0|0.883|0.972||||||This analysis assesses the effect of concomitant administration of dapagliflozin on the Pharmacokinetics of saxagliptin. The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.|
1653138|NCT01662999|3041632|Superiority or Other||Ratio of adjusted geometric mean|0.99|||||2-Sided|90.0|0.966|1.014||||||Treatment B versus C in AUC(0-T). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.|
1653139|NCT01662999|3041634|Superiority or Other||Ration of adjusted geometric mean|0.984|||||2-Sided|90.0|0.961|1.008||||||Treatment B versus C in AUC(INF). The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.|
1653140|NCT01662999|3041635|Superiority or Other||Ratio of adjusted geometric mean|0.943|||||2-Sided|90.0|0.867|1.026||||||The statistical model includes treatment and period as fixed effects and measurements within each participant as repeated measurements. The adjusted geometric means are from the mixed model.|
1653141|NCT01662960|3041650|Superiority|Test for the superiority of Mirror therapy over Divider therapy.|Slope|-0.36||||0.86|2-Sided|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA||||
1653142|NCT01662960|3041651|Superiority|Test for the superiority of Mirror therapy over Divider therapy.|Slope|10.7||||0.28|2-Sided|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA||||
1653322|NCT01656850|3042331|Superiority or Other|||||||0.5868|||||||Mixed Models Analysis||||
1653145|NCT01662960|3041655|Superiority|Test for the superiority of Mirror therapy over Divider therapy.|Slope|2.2||||0.443|2-Sided|||||ANCOVA analysis with post-treatment score as the dependent variable, therapy type (Mirror therapy or Divider Therapy) as the independent variable, and pre-treatment score as the covariate. P-value reported is for the main effect of therapy type.|ANCOVA||||
1653146|NCT01662908|3041660|Other||Mean Difference (Final Values)|8.8|Standard Error of the Mean|10.74|||2-Sided|95.0|-12.7|30.2|||||||
1653147|NCT01662882|3041669|Superiority or Other|||||||0.2118|||||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR|
1653148|NCT01662882|3041669|Superiority or Other|||||||0.001|||||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR|
1653149|NCT01662882|3041669|Superiority or Other|||||||0.0357|||||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR|
1653150|NCT01662882|3041669|Superiority or Other|||||||0.0039|||||||ANOVA|||Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.|
1653151|NCT01662882|3041670|Superiority or Other|||||||0.0008|||||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.|
1653152|NCT01662882|3041670|Superiority or Other|||||||0.4184|||||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.|
1653153|NCT01662882|3041670|Superiority or Other|||||||0.0004|||||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.|
1653154|NCT01662882|3041670|Superiority or Other|||||||0.0253|||||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.|
1653155|NCT01662791|3041678|Superiority or Other|||||||0.835|||||||t-test, 1 sided|||Comparison between the two groups at baseline for anxiety.|
1653156|NCT01662791|3041678|Superiority or Other|||||||0.872|||||||t-test, 1 sided|||Comparison between the two groups at baseline for depression|
1653157|NCT01662791|3041679|Superiority or Other|||||||0.351|||||||McNemar|||Comparison in case group between baseline and 3 months for nausea and vomiting sub-scale.|
1653158|NCT01662791|3041679|Superiority or Other|||||||0.554|||||||McNemar|||Comparison in case group between baseline and 3 months for GERD sub-scale.|
1653159|NCT01662791|3041679|Superiority or Other|||||||0.279|||||||McNemar|||Comparison in case group between baseline and 3 months for diarrhea sub-scale.|
1653160|NCT01662791|3041679|Superiority or Other|||||||0.244|||||||McNemar|||Comparison in case group between baseline and 3 months for abdominal discomfort sub-scale.|
1653161|NCT01662791|3041679|Superiority or Other|||||||0.38|||||||McNemar|||Comparison in case group between baseline and 3 months for dyspepsia sub-scale.|
1653162|NCT01662791|3041679|Superiority or Other|||||||0.056|||||||McNemar|||Comparison in case group between baseline and 3 months for constipation sub-scale.|
1653163|NCT01662791|3041680|Superiority or Other|||||||0.394|||||||Chi-squared|||Comparison between groups for nausea and vomiting sub-scale.|
1653164|NCT01662791|3041680|Superiority or Other|||||||0.57|||||||Chi-squared|||Comparison between groups for GERD sub-scale.|
1653165|NCT01662791|3041680|Superiority or Other|||||||0.736|||||||Chi-squared|||Comparison between groups for diarrhea sub-scale.|
1653166|NCT01662791|3041680|Superiority or Other|||||||0.8|||||||Chi-squared|||Comparison between groups for abdominal discomfort sub-scale.|
1653167|NCT01662791|3041680|Superiority or Other|||||||0.518|||||||Chi-squared|||Comparison between groups for dyspepsia sub-scale.|
1653168|NCT01662791|3041680|Superiority or Other|||||||0.303|||||||Chi-squared|||Comparison between groups for constipation sub-scale.|
1653169|NCT01662791|3041681|Superiority or Other|||||||0.186|||||||McNemar|||Comparison in case group between baseline and 3 months for summary index sub-scale.|
1653170|NCT01662791|3041681|Superiority or Other|||||||0.351|||||||McNemar|||Comparison in case group between baseline and 3 months for bodily discomfort sub-scale.|
1653171|NCT01662791|3041681|Superiority or Other|||||||0.276|||||||McNemar|||Comparison in case group between baseline and 3 months for communication sub-scale.|
1653172|NCT01662791|3041681|Superiority or Other|||||||0.16|||||||McNemar|||Comparison in case group between baseline and 3 months for cognition sub-scale.|
1653173|NCT01662791|3041681|Superiority or Other|||||||1|||||||McNemar|||Comparison in case group between baseline and 3 months for social support sub-scale.|
1653174|NCT01662791|3041681|Superiority or Other|||||||0.19|||||||McNemar|||Comparison in case group between baseline and 3 months for stigma sub-scale.|
1653175|NCT01662791|3041681|Superiority or Other|||||||0.041|||||||McNemar|||Comparison in case group between baseline and 3 months for emotional well-being sub-scale.|
1653176|NCT01662791|3041681|Superiority or Other|||||||0.159|||||||McNemar|||Comparison in case group between baseline and 3 months for activities of daily living sub-scale.|
1653177|NCT01662791|3041681|Superiority or Other|||||||0.167|||||||McNemar|||Comparison in case group between baseline and 3 months for mobility sub-scale.|
1653178|NCT01662791|3041682|Superiority or Other|||||||0.334|||||||Chi-squared|||Comparison between groups for summary index sub-scale.|
1653179|NCT01662791|3041682|Superiority or Other|||||||0.73|||||||Chi-squared|||Comparison between groups for bodily discomfort sub-scale.|
1653180|NCT01662791|3041682|Superiority or Other|||||||0.153|||||||Chi-squared|||Comparison between groups for communication sub-scale.|
1653181|NCT01662791|3041682|Superiority or Other|||||||0.205|||||||Chi-squared|||Comparison between groups for cognition sub-scale.|
1653182|NCT01662791|3041682|Superiority or Other|||||||0.466|||||||Chi-squared|||Comparison between groups for social support sub-scale.|
1653183|NCT01662791|3041682|Superiority or Other|||||||0.446|||||||Chi-squared|||Comparison between groups for stigma sub-scale.|
1653184|NCT01662791|3041682|Superiority or Other|||||||0.641|||||||Chi-squared|||Comparison between groups for emotional well-being sub-scale.|
1653185|NCT01662791|3041682|Superiority or Other|||||||0.206|||||||Chi-squared|||Comparison between groups for activities of daily living sub-scale.|
1653186|NCT01662791|3041682|Superiority or Other|||||||0.235|||||||Chi-squared|||Comparison between groups for mobility sub-scale.|
1653188|NCT01662635|3041704|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Continuous variables were summarized as arithmetic means, medians and standard deviations; and categorical variables were reported as proportions with 95% confidence intervals. Inferential comparisons were performed using Student’s t test. The x2 or Fisher’s exact tests were used to assess significance among categorical variables.|
1653189|NCT01662440|3041736|Non-Inferiority or Equivalence|The immune response of accelerated schedule of the JE vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 7 days after last active vaccine administration is greater than -10.|Difference in percentages of subjects|-1.0|||||2-Sided|95.0|-4.1|6.2||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as given according to an accelerated schedule as compared to JE vaccine (administered alone) as given according to a conventional schedule at 7day after last active vaccine administration.|
1653190|NCT01662440|3041737|Non-Inferiority or Equivalence|The immune response of accelerated schedule of the Rabies vaccine is considered non-inferior to the Rabies vaccine conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 28 days after last active vaccine administration is greater than -5.|Difference in percentages of subjects|-1.0|||||2-Sided|95.0|-3.8|1.4||||||Non-inferiority of the Rabies immune response (administered concomitantly with JE vaccine) as given according to an accelerated schedule as compared Rabies vaccine (administered alone) as given to a conventional schedule at day 28 after last active vaccination|
1653191|NCT01662440|3041738|Non-Inferiority or Equivalence|The conventional schedule of JE vaccine co-administered with Rabies vaccine considered non inferior to the conventional schedule of JE vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMTs measured 28 days after last active vaccination is greater than 0.5.|Ratio of GMTs|0.88|||||2-Sided|95.0|0.68|1.13||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as compared to JE vaccine (administered alone) as given according to conventional schedule at day 28 after last active vaccination.|
1653192|NCT01662440|3041739|Non-Inferiority or Equivalence|The conventional schedule of Rabies vaccine co-administered with JE vaccine considered non inferior to the conventional schedule of Rabies vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMCs measured 28 days after last active vaccination is greater than 0.667.|Between groups ratio of GMCs|1.07|||||2-Sided|95.0|0.86|1.32||||||Non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) as compared to Rabies vaccines (administered alone) as given according to conventional schedule at 28day after last active vaccination|
1653193|NCT01662440|3041740|Non-Inferiority or Equivalence|The immune response of accelerated schedule of the JE vaccine is considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 28 days after last active vaccination is greater than -10.|Difference in percentages of subjects|-1.0|||||2-Sided|97.5|-4.8|7.9||||||Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) accelerated schedule as compared to conventional schedule at 28 day after last active vaccination|
1653194|NCT01662440|3041741|Non-Inferiority or Equivalence|The immune response of accelerated schedule of the Rabies vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% Confidence Intervals (CI) of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 7 days after last active vaccination is greater than -5.|Difference in percentages of subjects|0.0|||||2-Sided|97.5|-2.8|2.8||||||To establish non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) accelerated schedule as compared to conventional schedule at 7 days after last active vaccination.|
1653195|NCT01661933|3041856|Superiority or Other||||||=|0|||||||Mixed effects model.||||
1653196|NCT01661933|3041857|Superiority or Other||||||=|0|||||||Binomial distribution|||The null hypothesis was that irrespective of hookworm infection, GC-1g would result in a 2-point or more deterioration in the Marsh score. A binomial (yes=deterioration or no=no deterioration) distribution was applied to pre- and post-GC-1g paired biopsies.|
1653197|NCT01661933|3041858|Superiority or Other||||||=|0|||||||t-test, 2 sided||||
1653198|NCT01661933|3041859|Superiority or Other|||||||0.693|||||||t-test, 2 sided||||
1653199|NCT01661140|3041957|Non-Inferiority or Equivalence|Non-inferiority if the difference between treatments is statistically significant and the lower limit of the 95% confidence interval (CI) is greater than 0.9.|Odds Ratio (OR)|1.803||||0.036|2-Sided|95.0|1.037|3.133|||Analysis by logistic regression|||Comparison was Tapering MTX : MTX maintenance. Last post-baseline EULAR response recorded used for participants with a missing result at Week 60.|
1653200|NCT01660763|3041992|Superiority or Other||Mean Difference (Final Values)|87.59|Standard Error of the Mean|10.88|<|0.001|2-Sided|95.0|66.2|108.98|||ANCOVA||||
1653201|NCT01660451|3042019|Superiority or Other (legacy)||Hodges-Lehmann-estimate|0.0|||||2-Sided|95.0|-0.5|3.2||||||Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.|
1653202|NCT01660451|3042020|Superiority or Other (legacy)||Hodges-Lehmann-estimate|1.0|||||2-Sided|95.0|0.5|2.5||||||Hodges-Lehmann-estimate was used to calculate change to Week 16 and 95% confidence interval.|
1653203|NCT01660451|3042026|Superiority or Other (legacy)||Response rate|51.41||||0.0039|2-Sided|95.0|42.88|59.87||0.01|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 40%.|
1653204|NCT01660451|3042027|Superiority or Other (legacy)||Response rate|31.25||||0.0001|2-Sided|90.0|20.35|43.97||0.0001|Exact binominal test|P-value was based on the original patients in the aggressive arm (for the first 34 patients), not including the additional recruited patients.||Response rate was statistically compared by exact binomial test if higher than 5%.|
1653205|NCT01660451|3042027|Superiority or Other (legacy)||Response rate|46.88||||0.0001|2-Sided|90.0|31.54|62.66||0.0001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 5%.|
1653206|NCT01660451|3042028|Superiority or Other (legacy)||Response rate|59.15|||<|0.0001|2-Sided|95.0|50.6|67.32||0.001|Exact binominal test|||Response rate was statistically compared by exact binomial test if higher than 40%.|
1653323|NCT01656850|3042332|Superiority or Other|||||||0.9784|||||||Mixed Models Analysis||||
1653207|NCT01660451|3042029|Superiority or Other (legacy)||Response rate|27.08||||0.0001|2-Sided|90.0|16.83|39.57||0.0001|Exact binominal test|P-value was based on the original patients in the aggressive arm (for the first 34 patients), not including the additional recruited patients.||Response rate was statistically compared by exact binomial test if higher than 5%.|
1653208|NCT01660451|3042029|Superiority or Other (legacy)||Response rate|45.45||||0.0001|2-Sided|90.0|30.49|61.06||0.0001|Exact binomial test|||Response rate was statistically compared by exact binomial test if higher than 5%.|
1653209|NCT01660412|3042030|Other||Mean Difference (Final Values)|1.42|Standard Deviation|2.17|<|0.0001|2-Sided|95.0|0.85|2.0|||t-test, 2 sided||||
1653210|NCT01659996|3042078|Non-Inferiority or Equivalence|If the upper limit of the two-sided 95% CI of the difference between the two proportions was < δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-0.092|||||2-Sided|95.0|-3.62|3.66||||||Pertactin (PRN) antigen: The null hypothesis (H0: pp – ppm > δ) was tested against the alternative hypothesis (H1: pp – ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PRN), with δ = 0.10.|
1653211|NCT01659996|3042078|Non-Inferiority or Equivalence|If the upper limit of the two-sided 95% CI of the difference between the two proportions was < δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|0.867|||||2-Sided|95.0|-2.54|4.53||||||Filamentous hemagglutinin (FHA) antigen: The null hypothesis (H0: pp – ppm > δ) was tested against the alternative hypothesis (H1: pp – ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (FHA), with δ = 0.10.|
1653212|NCT01659996|3042078|Non-Inferiority or Equivalence|If the upper limit of the two-sided 95% CI of the difference between the two proportions was < δ for each antibody and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-1.22|||||2-Sided|95.0|-5.44|3.19||||||Pertussis toxoid (PT) antigen: The null hypothesis (H0: pp – ppm > δ) was tested against the alternative hypothesis (H1: pp – ppm ≤ δ), where pp and ppm were the proportions of subjects in Group 3 and Group 2, respectively, who achieved a pertussis vaccine response in antibodies against the pertussis antigen (PT), with δ = 0.10.|
1653213|NCT01659996|3042079|Non-Inferiority or Equivalence|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|1.11|||||2-Sided|95.0|0.937|1.31||||||Pertactin (PRN): The null hypothesis (H0: GMCp / GMCpm > 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PRN) in Group 3 and in Group 2, respectively|
1653214|NCT01659996|3042079|Non-Inferiority or Equivalence|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|0.968|||||2-Sided|95.0|0.866|1.08||||||Filamentous hemagglutinin (FHA): The null hypothesis (H0: GMCp / GMCpm > 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (FHA) in Group 3 and in Group 2, respectively|
1653215|NCT01659996|3042079|Non-Inferiority or Equivalence|Assuming that the antibodies concentration was log normally distributed, if the upper limit of the two-sided 95% CI of the ratio of the two GMCs is ≤ 1.5 for each antigen, the inferiority assumption was to be rejected.|Mean Difference (Final Values)|0.949|||||2-Sided|95.0|0.852|1.06||||||Pertussis toxoid (PT): The null hypothesis (H0: GMCp / GMCpm > 1.5) was tested against the alternative hypothesis (H1: GMCp / GMCpm ≤ 1.5), where GMCp and GMCpm were the GMCs of antibodies against the pertussis antigen (PT) in Group 3 and in Group 2, respectively|
1653216|NCT01659996|3042084|Non-Inferiority or Equivalence|If the upper limit of the two-sided 95% CI of the difference between the two proportions was < δ for serogroup W-135 and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|1.28|||||2-Sided|95.0|-0.84|3.67||||||Meningococcal serogroup W-135: The null hypothesis (H0: pm – ppm > δ) was tested against the alternative hypothesis (H1: pm – ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.|
1653217|NCT01659996|3042084|Non-Inferiority or Equivalence|If the upper limit of the two-sided 95% CI of the difference between the two proportions was < δ for serogroup Y and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|2.46|||||2-Sided|95.0|0.14|5.14||||||Meningococcal serogroup Y: The null hypothesis (H0: pm – ppm > δ) was tested against the alternative hypothesis (H1: pm – ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.|
1653218|NCT01659996|3042084|Non-Inferiority or Equivalence|If the upper limit of the two-sided 95% CI of the difference between the two proportions was < δ for serogroup C and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|1.27|||||2-Sided|95.0|-0.84|3.64||||||Meningococcal serogroup C: The null hypothesis (H0: pm – ppm > δ) was tested against the alternative hypothesis (H1: pm – ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.|
1653219|NCT01659996|3042084|Non-Inferiority or Equivalence|If the upper limit of the two-sided 95% confidence interval (CI) of the difference between the two proportions was < δ for serogroup A and assuming the difference between the two proportions was normally distributed, the inferiority assumption was to be rejected.|Difference between 2 percentages|-0.11|||||2-Sided|95.0|-3.11|2.93||||||Meningococcal serogroup A: The null hypothesis (H0: pm – ppm > δ) was tested against the alternative hypothesis (H1: pm – ppm ≤ δ), where pm and ppm were the proportions of subjects in Group 1 and in Group 2, respectively, who achieved a Menactra vaccine response for meningococcal serogroups A, C, Y and W-135, with δ = 0.10.|
1653223|NCT01659021|3042120|Superiority||Hazard Ratio (HR)|0.79||||0.247|2-Sided|95.0|0.54|1.15||P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, IGHV mutation, and disease status).|Log Rank||||
1653224|NCT01659021|3042121|Superiority||Odds Ratio (OR)|483.16|||<|0.0001|2-Sided|95.0|94.63|2467.02||P-value was calculated from the CMH Chi-square test stratified by stratification factors.|Cochran-Mantel-Haenszel||Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.||
1653225|NCT01659021|3042122|Superiority||Odds Ratio (OR)|16.85|||<|0.0001|2-Sided|95.0|8.17|34.76||P-value was calculated from the Cochran-Mantel-Haenszel (CMH) Chi-square test stratified by stratification factors.|Cochran-Mantel-Haenszel||Odds ratio and 95% CIs were calculated from the CMH Chi-square test stratified by stratification factors.||
1653226|NCT01659021|3042123|Superiority||Hazard Ratio (HR)|0.26|||<|0.0001|2-Sided|95.0|0.18|0.37||P-value is from stratified log-rank test, adjusted for randomization stratification factors (17p deletion/TP53 mutation, immunoglobulin heavy chain variable region (IGHV) mutation, and disease status).|Log Rank||Hazard Ratio and 95% confidence intervals (CI) are from the proportional hazard model, adjusted for randomization stratification factors.||
1653227|NCT01658943|3042126|Superiority or Other|||||||0.15|||||||Log Rank||||
1653228|NCT01658579|3042161|Superiority or Other||Least Squares (LS) Mean Difference|0.75|Standard Error of the Mean|2.179||0.7304|2-Sided|95.0|-3.614|5.124|||Linear Mixed Model|||Analysis was performed using a linear mixed model with treatment and period as fixed effects, and participant as random effect.|
1653229|NCT01658514|3042162|Superiority or Other||||||<|0.0001||||||R² for placebo-adjusted change from pre-dose value in lactate versus metformin concentration|Pearson Correlation||||
1653230|NCT01658514|3042162|Superiority or Other||||||<|0.9444||||||R² for Placebo-adjusted Change from Pre-dose Value in Lactate Versus Metformin Concentration|Pearson Correlation||||
1653231|NCT01658514|3042163|Superiority or Other||% Ratio of LS Means|54.6||||0.0097|2-Sided|90.0|37.68|79.11||p-values <0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment*renal group as fixed effects and subject nested within sequence as a random effect.||For the Severe RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.|
1653232|NCT01658514|3042163|Superiority or Other||% Ratio of LS Means|56.6||||0.0064|2-Sided|90.0|40.73|78.63||p-values <0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment*renal group as fixed effects and subject nested within sequence as a random effect.||For the Moderate RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.|
1653233|NCT01658514|3042163|Superiority or Other||% Ratio of LS Means|77.3||||0.1691|2-Sided|90.0|56.72|105.41||p-values <0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment*renal group as fixed effects and subject nested within sequence as a random effect.||For the Mild RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.|
1653234|NCT01658514|3042163|Superiority or Other||% Ratio of LS Means|65.5||||0.0474|2-Sided|90.0|46.32|92.68||p-values <0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment*renal group as fixed effects and subject nested within sequence as a random effect.||For the Normal Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.|
1653235|NCT01658514|3042164|Superiority or Other||% Ratio of LS Means|52.4||||0.0025|2-Sided|90.0|37.61|73.02||p-values <0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment*renal group as fixed effects and subject nested within sequence as a random effect.||For the Severe RI Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.|
1653236|NCT01658514|3042164|Superiority or Other||% Ratio of LS Means|56.7||||0.0028|2-Sided|90.0|42.25|76.1||p-values <0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment*renal group as fixed effects and subject nested within sequence as a random effect.||For the Moderate RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.|
1653237|NCT01658514|3042164|Superiority or Other||% Ratio of LS Means|73.8||||0.0733|2-Sided|90.0|55.97|97.43||p-values <0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment*renal group as fixed effects and subject nested within sequence as a random effect.||For the Mild RI Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.|
1653238|NCT01658514|3042164|Superiority or Other||% Ratio of LS Means|51.5||||0.0011|2-Sided|90.0|37.77|70.23||p-values <0.10 are considered statistically significant|ANOVA|Included treatment, renal group, sequence, period and treatment*renal group as fixed effects and subject nested within sequence as a random effect.||For the Normal Renal Function Cohort. Met XR is the denominator for the % ratio of LS means and the comparator for the p-values.|
1653239|NCT01657903|3042210|Superiority or Other||Adjusted Mean Difference|11.66|||<|0.0001|2-Sided|95.0|8.28|15.03||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1653240|NCT01657903|3042210|Superiority or Other||Adjusted Mean Difference|9.45|||<|0.0001|2-Sided|95.0|6.07|12.82||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1653261|NCT01657305|3042255|Superiority or Other||Mean Difference (Final Values)|3.9|Standard Deviation|12.9|=|0|2-Sided|95.0|1.5|6.4||Day 28|t-test, 2 sided||Difference in degree of epithelialization [%] (Oleogel-S10 minus standard of care)||
1653324|NCT01656850|3042333|Superiority or Other|||||||0.3837|||||||Mixed Models Analysis||||
1653241|NCT01657903|3042210|Superiority or Other||Adjusted Mean Difference|9.36|||<|0.0001|2-Sided|95.0|6.01|12.72||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1653242|NCT01657903|3042211|Superiority or Other||Adjusted Mean Difference|40.83|||<|0.0001|2-Sided|95.0|34.06|47.61||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.|
1653243|NCT01657903|3042211|Superiority or Other||Adjusted Mean Difference|41.28|||<|0.0001|2-Sided|95.0|34.51|48.06||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.|
1653244|NCT01657903|3042211|Superiority or Other||Adjusted Mean Difference|41.15|||<|0.0001|2-Sided|95.0|34.42|47.89||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the treatments in comparison to be equal with respect to %RER. Statistical tests were 2-sided with a significance level of 0.05.|
1653245|NCT01657877|3042212|Non-Inferiority or Equivalence|The success criterion for this study was to observe the upper bound of the 2-sided 95% confidence interval for difference in % change in SMHR to be <= 6 units SMHR i.e. 1500 ppm fluoride as SMFP + 5% CSP is no more than 6 units inferior to the 1500 ppm fluoride as SMFP + 0 % CSP dentifrice.|Adjusted mean difference|-2.23||||0.2601|2-Sided|95.0|-6.11|1.66|||ANOVA|Based on the mixed effects ANOVA considering treatment and study period as factors, and subject as random effect|Difference is 1500 ppm fluoride as SMFP and 0 % CSP minus 1500 ppm fluoride as SMFP and 5 % CSP such that a positive difference favors 1500 ppm fluoride as SMFP and 0 % CSP|The null hypothesis states that the population mean for the 1500 ppm fluoride as SMFP + 0% CSP minus the population mean for the 1500 ppm fluoride as SMFP and 5% CSP dentifrice is more than 6 %.|
1653246|NCT01657799|3042215|Superiority||Hazard Ratio (HR)|1.295||||0.289|2-Sided|95.0|0.803|2.086|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or > 2.5) at screening.|||
1653247|NCT01657799|3042215|Superiority||Hazard Ratio (HR)|1.047||||0.86|2-Sided|95.0|0.626|1.754|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or > 2.5) at screening.|||
1653248|NCT01657799|3042215|Superiority|||||||0.301|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or > 2.5) at screening.|||
1653249|NCT01657799|3042215|Superiority|||||||0.864|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or > 2.5) at screening.|||
1653250|NCT01657799|3042216|Superiority||Hazard Ratio (HR)|1.181||||0.534|2-Sided|95.0|0.698|1.999|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or > 2.5) at screening.|||
1653251|NCT01657799|3042216|Superiority||Hazard Ratio (HR)|1.301||||0.313|2-Sided|95.0|0.78|2.168|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or > 2.5) at screening.|||
1653252|NCT01657799|3042216|Superiority|||||||0.536|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or > 2.5) at screening.|||
1653253|NCT01657799|3042216|Superiority|||||||0.314|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or > 2.5) at screening.|||
1653254|NCT01657799|3042217|Superiority|||||||0.898|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by GPA score (≤ 2.5 or > 2.5) at screening.|||
1653255|NCT01657799|3042217|Superiority|||||||0.535|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by GPA score (≤ 2.5 or > 2.5) at screening.|||
1653256|NCT01657799|3042218|Superiority||Hazard Ratio (HR)|0.981||||0.906|2-Sided|95.0|0.71|1.354|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or > 2.5) at screening. Nominal P-values were reported.|||
1653257|NCT01657799|3042218|Superiority||Hazard Ratio (HR)|0.985||||0.927|2-Sided|95.0|0.716|1.355|||Cox proportional hazard model|Cox proportional hazard model stratified by GPA score (≤ 2.5 or > 2.5) at screening. Nominal P-values were reported.|||
1653258|NCT01657799|3042218|Superiority|||||||0.909|||||||Log Rank|Log-rank test stratified by GPA score (≤ 2.5 or > 2.5) at screening. Nominal P-values were reported.||The primary analysis used a Hochberg testing procedure to preserve the familywise error rate for multiple comparisons, where the larger P-value for the comparisons of veliparib 50 mg BID + WBRT with placebo BID + WBRT and veliparib 200 mg BID + WBRT with placebo BID + WBRT were compared to an α = 0.05. If statistically significant (P ≤ 0.05), both comparisons were considered significant. If the larger P-value was not statistically significant, the smaller P-value was compared to an α = 0.025.|
1653259|NCT01657799|3042218|Superiority|||||||0.933|||||||Log Rank|Log-rank test stratified by graded prognostic assessment (GPA) score (≤ 2.5 or > 2.5) at screening. Nominal P-values were reported.||The primary analysis used a Hochberg testing procedure to preserve the familywise error rate for multiple comparisons, where the larger P-value for the comparisons of veliparib 50 mg BID + WBRT with placebo BID + WBRT and veliparib 200 mg BID + WBRT with placebo BID + WBRT were compared to an α = 0.05. If statistically significant (P ≤ 0.05), both comparisons were considered significant. If the larger P-value was not statistically significant, the smaller P-value was compared to an α = 0.025.|
1653260|NCT01657760|3042219|Equivalence|80% power to detect difference p<0.05 two tailed|Mean Difference (Final Values)|0.01|Standard Deviation|0.03||0.87|2-Sided|||||ANOVA, uncorrected for MC.|ANOVA||||
1653313|NCT01656850|3042322|Superiority or Other|||||||0.1512|||||||Mixed Models Analysis||||
1653262|NCT01657305|3042255|Superiority or Other||Mean Difference (Final Values)|6.4|Standard Deviation|14.1|<|0.0001|2-Sided|95.0|3.7|9.1||Day 21|t-test, 2 sided||Difference in degree of epithelialization [%] (Oleogel-S10 minus standard of care)||
1653263|NCT01657305|3042255|Superiority or Other||Mean Difference (Final Values)|7.4|Standard Deviation|18.3|<|0.0001|2-Sided|95.0|3.9|10.9||Day 18|t-test, 2 sided||Difference in degree of epithelialization [%] (Oleogel-S10 minus standard of care)||
1653264|NCT01657305|3042255|Superiority or Other||Mean Difference (Final Values)|7.9|Standard Deviation|17.0|<|0.0001|2-Sided|95.0|4.6|11.1||Day 14|t-test, 2 sided||Difference in degree of epithelialization [%] (Oleogel-S10 minus standard of care)||
1653265|NCT01657305|3042255|Superiority or Other||Mean Difference (Final Values)|10.1|Standard Deviation|17.0|<|0.0001|2-Sided|95.0|6.9|13.4||Day 10|t-test, 2 sided||Difference in degree of epithelialization [%] (Oleogel-S10 minus standard of care)||
1653266|NCT01657305|3042255|Superiority or Other||Mean Difference (Final Values)|8.6|Standard Deviation|13.4|<|0.0001|2-Sided|95.0|6.0|11.2||Day 7|t-test, 2 sided||Difference in degree of epithelialization [%] (Oleogel-S10 minus standard of care)||
1653267|NCT01657305|3042259|Superiority or Other||||||<|0.0001||||||2-sided, significance level = 0.05|t-test, 2 sided|||"All participants received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: δ = 0 and H1: δ ≠ 0 with δ being the difference in time to wound closure between treatments.~Negative values for the intra-individual time difference indicate faster healing of the Oleogel-S10-treated wound half.~For right-censored observations (no wound closure observed in blinded photo evaluation), wound closure was conservatively calculated as +1 day after the last photo."|
1653268|NCT01657292|3042270|Superiority or Other||||||<|0.0001||||||1-sided, significance level = 0.025|Binomial test|||"All patients received both treatments and treatments were intra-individually compared.~Hypotheses tested: H0: s0 ≤0.5 and H1: s0 >0.5 (with s0=rate of superiority of Oleogel-S10)."|
1653269|NCT01657266|3042278|Superiority or Other|||||||1|||||||Pearson´s Chi-square test||||
1653270|NCT01657032|3042292|Non-Inferiority or Equivalence|The differences between the study groups were considered significant when the P value was <0.05.||||||0.43|||||||Wilcoxon (Mann-Whitney)||||
1653271|NCT01656889|3042312|Superiority or Other||||||<|0.05|||||||Kaplan-Meier Survival analysis||||
1653272|NCT01656889|3042313|Superiority or Other|||||||0.6753|||||||ANCOVA|||Week 12|
1653273|NCT01656889|3042313|Superiority or Other|||||||0.6358|||||||ANCOVA|||Week 11|
1653274|NCT01656889|3042313|Superiority or Other|||||||0.3409|||||||ANCOVA|||Week 10|
1653275|NCT01656889|3042313|Superiority or Other|||||||0.5138|||||||ANCOVA|||Week 09|
1653276|NCT01656889|3042313|Superiority or Other|||||||0.4423|||||||ANCOVA|||Week 08|
1653277|NCT01656889|3042313|Superiority or Other|||||||0.499|||||||ANCOVA|||Week 07|
1653278|NCT01656889|3042313|Superiority or Other|||||||0.1775|||||||ANCOVA|||Week 06|
1653279|NCT01656889|3042313|Superiority or Other|||||||0.9923|||||||ANCOVA|||Week 05|
1653280|NCT01656889|3042313|Superiority or Other|||||||0.2891|||||||ANCOVA||||
1653281|NCT01656889|3042313|Superiority or Other|||||||0.6744|||||||ANCOVA|||Week 03|
1653282|NCT01656889|3042313|Superiority or Other|||||||0.7083|||||||ANCOVA|||Week 02|
1653283|NCT01656889|3042313|Superiority or Other|||||||0.9853|||||||ANCOVA|||Week 01|
1653284|NCT01656889|3042314|Superiority or Other|||||||0.9366|||||||ANCOVA||||
1653285|NCT01656889|3042314|Superiority or Other|||||||0.7032|||||||ANCOVA|||Week 11|
1653286|NCT01656889|3042314|Superiority or Other|||||||0.5227|||||||ANCOVA|||Week 10|
1653287|NCT01656889|3042314|Superiority or Other|||||||0.4913|||||||ANCOVA|||Week 09|
1653288|NCT01656889|3042314|Superiority or Other|||||||0.8027|||||||ANCOVA|||Week 08|
1653289|NCT01656889|3042314|Superiority or Other|||||||0.399|||||||ANCOVA|||Week 07|
1653290|NCT01656889|3042314|Superiority or Other|||||||0.1815|||||||ANCOVA|||Week 06|
1653291|NCT01656889|3042314|Superiority or Other|||||||0.3004|||||||ANCOVA|||Week 05|
1653292|NCT01656889|3042314|Superiority or Other|||||||0.4471|||||||ANCOVA|||Week 04|
1653293|NCT01656889|3042314|Superiority or Other|||||||0.905|||||||ANCOVA|||Week 03|
1653294|NCT01656889|3042314|Superiority or Other|||||||0.9398|||||||ANCOVA|||Week 02|
1653295|NCT01656889|3042314|Superiority or Other|||||||0.3601|||||||ANCOVA|||Week 01|
1653296|NCT01656889|3042316|Superiority or Other|||||||0.6687|||||||Cochran-Mantel-Haenszel|||Treatment Week 12|
1653297|NCT01656889|3042316|Superiority or Other|||||||0.8083|||||||Cochran-Mantel-Haenszel|||Treatment Week 11|
1653298|NCT01656889|3042316|Superiority or Other|||||||0.8682|||||||Cochran-Mantel-Haenszel|||Treatment Week 10|
1653299|NCT01656889|3042316|Superiority or Other|||||||0.3989|||||||Cochran-Mantel-Haenszel|||Treatment Week 09|
1653300|NCT01656889|3042316|Superiority or Other|||||||0.3896|||||||Cochran-Mantel-Haenszel|||Treatment Week 08|
1653301|NCT01656889|3042316|Superiority or Other|||||||0.02913|||||||Cochran-Mantel-Haenszel|||Treatment Week 07|
1653302|NCT01656889|3042316|Superiority or Other|||||||0.5528|||||||Cochran-Mantel-Haenszel|||Treatment Week 06|
1653303|NCT01656889|3042316|Superiority or Other|||||||0.3823|||||||Cochran-Mantel-Haenszel|||Treatment Week 05|
1653304|NCT01656889|3042316|Superiority or Other|||||||0.1502|||||||Cochran-Mantel-Haenszel|||Treatment Week 04|
1653305|NCT01656889|3042316|Superiority or Other|||||||0.2792|||||||Cochran-Mantel-Haenszel|||Treatment Week 03|
1653306|NCT01656889|3042316|Superiority or Other|||||||0.3843|||||||Cochran-Mantel-Haenszel|||Treatment Week 02|
1653307|NCT01656889|3042316|Superiority or Other|||||||0.6426|||||||Cochran-Mantel-Haenszel|||Treatment Week 01|
1653308|NCT01656889|3042317|Superiority or Other|||||||0.3675|||||||Regression, Cox||||
1653309|NCT01656889|3042318|Superiority or Other|||||||0.5896|||||||Cochran-Mantel-Haenszel|P-value is based on the chi-squared proportion of wounds closed in each group.|||
1653310|NCT01656850|3042319|Superiority or Other|||||||0.8528|||||||Mixed Models Analysis||||
1653311|NCT01656850|3042320|Superiority or Other|||||||0.1995|||||||Mixed Models Analysis||||
1653312|NCT01656850|3042321|Superiority or Other|||||||0.7364|||||||Mixed Models Analysis||||
1653325|NCT01656850|3042334|Superiority or Other|||||||0.2412|||||||Mixed Models Analysis||||
1653326|NCT01656850|3042335|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1653327|NCT01656850|3042336|Superiority or Other|||||||0.42|||||||Mixed Models Analysis||||
1653328|NCT01656850|3042337|Superiority or Other|||||||0.2786|||||||Mixed Models Analysis||||
1653329|NCT01656850|3042338|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1653330|NCT01656772|3042339|Non-Inferiority or Equivalence|The non-inferiority margin d= 0.07. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z < -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.||||||0.0441|||||||Z-statistic||||
1653331|NCT01656772|3042340|Non-Inferiority or Equivalence|The non-inferiority margin d = -0.05. The null hypothesis was to be rejected if Z > 1.645 or, equivalently, if the corresponding p-value was less than 0.05.||||||0.0405||||||Adjusted to take into account the correlation between multiple PVs on the same subject. The sample estimate of the intraclass correlation coefficient was calculated as the Pearson sample correlation coefficient for all pairs of observations.|Farrington and Manning|||The primary effectiveness endpoint is the successful navigation and EGM recording of each pre-specified pulmonary vein (PV). The RF ablation treatment was not part of the investigational procedure. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject.|
1653332|NCT01656759|3042341|Superiority or Other|||||||0.9|||||||t-test, 2 sided||||
1653333|NCT01656759|3042343|Superiority or Other|||||||0.9|||||||t-test, 2 sided||||
1653334|NCT01656759|3042344|Superiority or Other|||||||0.2|||||||t-test, 2 sided||||
1653335|NCT01656408|3042360|Superiority or Other||LS Mean Difference|-1.1|Standard Error of the Mean|2.0||0.565|2-Sided|90.0|-4.4|2.1|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653336|NCT01656408|3042361|Superiority or Other||LS Mean Difference|-3.8|Standard Error of the Mean|3.3||0.263|2-Sided|90.0|-9.3|1.8|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653337|NCT01656408|3042362|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|2.0||0.786|2-Sided|90.0|-4.0|2.9|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653338|NCT01656408|3042363|Superiority or Other||LS Mean Difference|-3.8|Standard Error of the Mean|2.6||0.161|2-Sided|90.0|-8.3|0.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 28|
1653339|NCT01656408|3042363|Superiority or Other||LS Mean Difference|-4.5|Standard Error of the Mean|2.2||0.061|2-Sided|90.0|-8.4|-0.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653340|NCT01656408|3042364|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|2.8||0.816|2-Sided|90.0|-5.4|4.0|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653341|NCT01656408|3042365|Superiority or Other||LS Mean Difference|1.7|Standard Error of the Mean|3.1||0.571|2-Sided|90.0|-3.4|6.9|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653342|NCT01656408|3042366|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|3.7||0.892|2-Sided|90.0|-7.1|6.1|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653343|NCT01656408|3042367|Superiority or Other||LS Mean Difference|-5.8|Standard Error of the Mean|2.9||0.063|2-Sided|90.0|-10.8|-0.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 28|
1653344|NCT01656408|3042367|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|1.6||0.83|2-Sided|90.0|-3.2|2.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653345|NCT01656408|3042368|Superiority or Other||LS Mean Difference|-2.6|Standard Error of the Mean|1.0||0.048|2-Sided|90.0|-4.7|-0.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653346|NCT01656408|3042369|Superiority or Other||LS Mean Difference|-2.4|Standard Error of the Mean|1.8||0.238|2-Sided|90.0|-6.0|1.2|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653347|NCT01656408|3042370|Superiority or Other||LS Mean Difference|-2.8|Standard Error of the Mean|1.0||0.038|2-Sided|90.0|-4.9|-0.8|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653348|NCT01656408|3042371|Superiority or Other||LS Mean Difference|-8.2|Standard Error of the Mean|1.2||0.001|2-Sided|90.0|-10.7|-5.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653349|NCT01656408|3042371|Superiority or Other||LS Mean Difference|-4.3|Standard Error of the Mean|0.3|<|0.0001|2-Sided|90.0|-5.0|-3.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653350|NCT01656408|3042372|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|2.4||0.87|2-Sided|90.0|-4.4|3.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653351|NCT01656408|3042373|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|3.6||0.906|2-Sided|90.0|-6.6|5.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653352|NCT01656408|3042374|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|2.6||0.91|2-Sided|90.0|-4.6|5.2|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653353|NCT01656408|3042375|Superiority or Other||LS Mean Difference|-12.9|Standard Error of the Mean|2.3||0.001|2-Sided|90.0|-17.2|-8.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 28|
1653354|NCT01656408|3042375|Superiority or Other||LS Mean Difference|-10.5|Standard Error of the Mean|4.4||0.046|2-Sided|90.0|-18.8|-2.3|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653355|NCT01656408|3042376|Superiority or Other||LS Mean Difference|-5.2|Standard Error of the Mean|3.5||0.161|2-Sided|90.0|-11.4|1.0|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653356|NCT01656408|3042377|Superiority or Other||LS Mean Difference|-1.0|Standard Error of the Mean|4.6||0.827|2-Sided|90.0|-9.3|7.2|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653357|NCT01656408|3042378|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|2.5||0.877|2-Sided|90.0|-4.9|4.1|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653358|NCT01656408|3042379|Superiority or Other||LS Mean Difference|-7.6|Standard Error of the Mean|3.0||0.028|2-Sided|90.0|-13.0|-2.2|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 15|
1653359|NCT01656408|3042379|Superiority or Other||LS Mean Difference|-5.6|Standard Error of the Mean|3.0||0.09|2-Sided|90.0|-11.0|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 6|
1653360|NCT01656408|3042379|Superiority or Other||LS Mean Difference|-2.3|Standard Error of the Mean|3.1||0.477|2-Sided|90.0|-7.9|3.3|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653361|NCT01656408|3042380|Superiority or Other||LS Mean Difference|3.3|Standard Error of the Mean|2.0||0.128|2-Sided|90.0|-0.3|6.8|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653362|NCT01656408|3042381|Superiority or Other||LS Mean Difference|6.7|Standard Error of the Mean|3.6||0.09|2-Sided|90.0|0.2|13.2|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653363|NCT01656408|3042382|Superiority or Other||LS Mean Difference|2.9|Standard Error of the Mean|2.8||0.317|2-Sided|90.0|-2.1|7.9|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653364|NCT01656408|3042383|Superiority or Other||LS Mean Difference|-3.9|Standard Error of the Mean|3.4||0.281|2-Sided|90.0|-10.0|2.3|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 15|
1653365|NCT01656408|3042383|Superiority or Other||LS Mean Difference|-4.3|Standard Error of the Mean|4.3||0.338|2-Sided|90.0|-11.9|3.4|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 6|
1653366|NCT01656408|3042383|Superiority or Other||LS Mean Difference|-1.3|Standard Error of the Mean|3.4||0.715|2-Sided|90.0|-7.4|4.8|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653367|NCT01656408|3042384|Superiority or Other||LS Mean Difference|-2.2|Standard Error of the Mean|3.1||0.475|2-Sided|90.0|-7.5|3.0|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653368|NCT01656408|3042384|Superiority or Other||LS Mean Difference|-7.8|Standard Error of the Mean|3.2||0.025|2-Sided|90.0|-13.3|-2.2|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653369|NCT01656408|3042384|Superiority or Other||LS Mean Difference|-2.4|Standard Error of the Mean|2.9||0.424|2-Sided|90.0|-7.4|2.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653370|NCT01656408|3042384|Superiority or Other||LS Mean Difference|2.9|Standard Error of the Mean|3.2||0.365|2-Sided|90.0|-2.5|8.3|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653371|NCT01656408|3042385|Superiority or Other||LS Mean Difference|1.0|Standard Error of the Mean|3.7||0.785|2-Sided|90.0|-5.4|7.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653372|NCT01656408|3042385|Superiority or Other||LS Mean Difference|-5.3|Standard Error of the Mean|3.2||0.109|2-Sided|90.0|-10.7|0.1|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653373|NCT01656408|3042385|Superiority or Other||LS Mean Difference|-0.6|Standard Error of the Mean|2.9||0.836|2-Sided|90.0|-5.6|4.4|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653374|NCT01656408|3042385|Superiority or Other||LS Mean Difference|5.5|Standard Error of the Mean|4.7||0.248|2-Sided|90.0|-2.5|13.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653375|NCT01656408|3042386|Superiority or Other||LS Mean Difference|-2.1|Standard Error of the Mean|3.8||0.591|2-Sided|90.0|-8.6|4.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653376|NCT01656408|3042386|Superiority or Other||LS Mean Difference|-4.2|Standard Error of the Mean|2.9||0.166|2-Sided|90.0|-9.3|0.8|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653377|NCT01656408|3042386|Superiority or Other||LS Mean Difference|-2.4|Standard Error of the Mean|3.0||0.429|2-Sided|90.0|-7.5|2.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653378|NCT01656408|3042386|Superiority or Other||LS Mean Difference|2.2|Standard Error of the Mean|3.2||0.512|2-Sided|90.0|-3.4|7.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1653379|NCT01656408|3042387|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|2.4||0.878|2-Sided|90.0|-4.5|3.8|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653380|NCT01656408|3042387|Superiority or Other||LS Mean Difference|-5.5|Standard Error of the Mean|2.2||0.023|2-Sided|90.0|-9.3|-1.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653381|NCT01656408|3042387|Superiority or Other||LS Mean Difference|-4.5|Standard Error of the Mean|2.5||0.088|2-Sided|90.0|-8.9|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653382|NCT01656408|3042387|Superiority or Other||LS Mean Difference|3.1|Standard Error of the Mean|2.0||0.139|2-Sided|90.0|-0.4|6.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653383|NCT01656408|3042387|Superiority or Other||LS Mean Difference|-3.9|Standard Error of the Mean|1.8||0.044|2-Sided|90.0|-7.0|-0.8|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653384|NCT01656408|3042387|Superiority or Other||LS Mean Difference|-8.4|Standard Error of the Mean|3.5||0.025|2-Sided|90.0|-14.4|-2.4|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653385|NCT01656408|3042387|Superiority or Other||LS Mean Difference|-6.0|Standard Error of the Mean|1.2|<|0.0001|2-Sided|90.0|-8.0|-4.0|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653386|NCT01656408|3042387|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|2.0|<|0.848|2-Sided|90.0|-3.8|3.0|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653387|NCT01656408|3042412|Superiority or Other||LS Mean Difference|2.5|Standard Error of the Mean|4.0||0.528|2-Sided|90.0|-4.1|9.2|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 28|
1653388|NCT01656408|3042412|Superiority or Other||LS Mean Difference|-3.0|Standard Error of the Mean|4.7||0.534|2-Sided|90.0|-10.9|4.9|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 22|
1653389|NCT01656408|3042412|Superiority or Other||LS Mean Difference|1.5|Standard Error of the Mean|3.4||0.666|2-Sided|90.0|-4.2|7.1|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 15|
1653390|NCT01656408|3042412|Superiority or Other||LS Mean Difference|2.2|Standard Error of the Mean|3.9||0.57|2-Sided|90.0|-4.3|8.8|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 8|
1653391|NCT01656408|3042412|Superiority or Other||LS Mean Difference|-1.4|Standard Error of the Mean|3.6||0.691|2-Sided|90.0|-7.5|4.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653392|NCT01656408|3042413|Superiority or Other||LS Mean Difference|-6.1|Standard Error of the Mean|3.5||0.105|2-Sided|90.0|-12.3|0.1|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 28|
1653393|NCT01656408|3042413|Superiority or Other||LS Mean Difference|-11.3|Standard Error of the Mean|3.1||0.003|2-Sided|90.0|-16.8|-5.9|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653394|NCT01656408|3042414|Superiority or Other||LS Mean Difference|5.1|Standard Error of the Mean|2.9||0.086|2-Sided|90.0|0.2|10.0|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 28|
1653395|NCT01656408|3042414|Superiority or Other||LS Mean Difference|3.0|Standard Error of the Mean|2.4||0.214|2-Sided|90.0|-1.0|7.1|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 22|
1653396|NCT01656408|3042414|Superiority or Other||LS Mean Difference|2.4|Standard Error of the Mean|2.8||0.404|2-Sided|90.0|-2.4|7.1|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 15|
1653397|NCT01656408|3042414|Superiority or Other||LS Mean Difference|3.9|Standard Error of the Mean|2.8||0.158|2-Sided|90.0|-0.7|8.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 8|
1653398|NCT01656408|3042414|Superiority or Other||LS Mean Difference|0.7|Standard Error of the Mean|2.4||0.756|2-Sided|90.0|-3.2|4.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653399|NCT01656408|3042415|Superiority or Other||LS Mean Difference|-0.8|Standard Error of the Mean|3.4||0.817|2-Sided|90.0|-6.9|5.2|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 28|
1653400|NCT01656408|3042415|Superiority or Other||LS Mean Difference|-3.8|Standard Error of the Mean|3.4||0.279|2-Sided|90.0|-9.7|2.1|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653401|NCT01656408|3042416|Superiority or Other||LS Mean Difference|1.4|Standard Error of the Mean|1.3||0.333|2-Sided|90.0|-1.2|4.0|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653402|NCT01656408|3042416|Superiority or Other||LS Mean Difference|-2.4|Standard Error of the Mean|2.0||0.281|2-Sided|90.0|-6.5|1.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653403|NCT01656408|3042417|Superiority or Other||LS Mean Difference|-5.9|Standard Error of the Mean|2.1||0.034|2-Sided|90.0|-10.1|-1.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653404|NCT01656408|3042417|Superiority or Other||LS Mean Difference|-5.6|Standard Error of the Mean|2.8||0.099|2-Sided|90.0|-11.1|0.0|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653405|NCT01656408|3042418|Superiority or Other||LS Mean Difference|1.3|Standard Error of the Mean|3.1||0.682|2-Sided|90.0|-4.0|6.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 28|
1653406|NCT01656408|3042418|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|2.9||0.906|2-Sided|90.0|-5.2|4.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 22|
1653407|NCT01656408|3042418|Superiority or Other||LS Mean Difference|2.1|Standard Error of the Mean|3.4||0.547|2-Sided|90.0|-3.7|7.9|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 15|
1653408|NCT01656408|3042418|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|3.2||0.934|2-Sided|90.0|-5.7|5.2|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 8|
1653409|NCT01656408|3042418|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|2.6||0.999|2-Sided|90.0|-4.4|4.4|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653410|NCT01656408|3042419|Superiority or Other||LS Mean Difference|-6.0|Standard Error of the Mean|2.6||0.055|2-Sided|90.0|-11.0|-1.1|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 28|
1653411|NCT01656408|3042419|Superiority or Other||LS Mean Difference|-10.8|Standard Error of the Mean|3.8||0.025|2-Sided|90.0|-18.0|-3.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653412|NCT01656408|3042420|Superiority or Other||LS Mean Difference|4.3|Standard Error of the Mean|1.9||0.046|2-Sided|90.0|0.9|7.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 15|
1653413|NCT01656408|3042420|Superiority or Other||LS Mean Difference|1.9|Standard Error of the Mean|3.7||0.627|2-Sided|90.0|-4.8|8.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 6|
1653414|NCT01656408|3042420|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|3.0||0.942|2-Sided|90.0|-5.1|5.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653415|NCT01656408|3042421|Superiority or Other||LS Mean Difference|3.0|Standard Error of the Mean|5.2||0.578|2-Sided|90.0|-6.3|12.3|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 15|
1653416|NCT01656408|3042421|Superiority or Other||LS Mean Difference|7.4|Standard Error of the Mean|4.8||0.15|2-Sided|90.0|-1.2|15.9|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 6|
1653417|NCT01656408|3042421|Superiority or Other||LS Mean Difference|4.5|Standard Error of the Mean|4.7||0.357|2-Sided|90.0|-3.9|12.8|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653418|NCT01656408|3042422|Superiority or Other||LS Mean Difference|1.8|Standard Error of the Mean|2.0||0.387|2-Sided|90.0|-1.7|5.2|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 15|
1653419|NCT01656408|3042422|Superiority or Other||LS Mean Difference|0.8|Standard Error of the Mean|0.9||0.381|2-Sided|90.0|-0.8|2.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 6|
1653420|NCT01656408|3042422|Superiority or Other||LS Mean Difference|-1.5|Standard Error of the Mean|2.5||0.563|2-Sided|90.0|-6.0|3.0|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653421|NCT01656408|3042423|Superiority or Other||LS Mean Difference|6.3|Standard Error of the Mean|7.1||0.392|2-Sided|90.0|-6.3|18.9|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 15|
1653422|NCT01656408|3042423|Superiority or Other||LS Mean Difference|3.7|Standard Error of the Mean|8.1||0.658|2-Sided|90.0|-10.8|18.1|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 6|
1653989|NCT01646177|3043411|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653423|NCT01656408|3042423|Superiority or Other||LS Mean Difference|-0.9|Standard Error of the Mean|4.5||0.855|2-Sided|90.0|-9.0|7.3|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653424|NCT01656408|3042424|Superiority or Other||LS Mean Difference|1.1|Standard Error of the Mean|3.1||0.726|2-Sided|90.0|-4.2|6.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653425|NCT01656408|3042424|Superiority or Other||LS Mean Difference|-8.4|Standard Error of the Mean|2.5||0.002|2-Sided|90.0|-12.7|-4.1|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653426|NCT01656408|3042424|Superiority or Other||LS Mean Difference|-3.4|Standard Error of the Mean|2.8||0.234|2-Sided|90.0|-8.1|1.4|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653427|NCT01656408|3042424|Superiority or Other||LS Mean Difference|-1.5|Standard Error of the Mean|2.3||0.527|2-Sided|90.0|-5.5|2.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653428|NCT01656408|3042424|Superiority or Other||LS Mean Difference|-2.1|Standard Error of the Mean|3.5||0.556|2-Sided|90.0|-8.0|3.9|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653429|NCT01656408|3042424|Superiority or Other||LS Mean Difference|-10.4|Standard Error of the Mean|2.7||0.001|2-Sided|90.0|-15.0|-5.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653430|NCT01656408|3042424|Superiority or Other||LS Mean Difference|-5.3|Standard Error of the Mean|2.8||0.077|2-Sided|90.0|-10.1|-0.4|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653431|NCT01656408|3042424|Superiority or Other||LS Mean Difference|1.9|Standard Error of the Mean|3.9||0.635|2-Sided|90.0|-4.9|8.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653432|NCT01656408|3042425|Superiority or Other||LS Mean Difference|-2.4|Standard Error of the Mean|4.6||0.605|2-Sided|90.0|-10.4|5.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653433|NCT01656408|3042425|Superiority or Other||LS Mean Difference|-8.7|Standard Error of the Mean|3.6||0.023|2-Sided|90.0|-14.9|-2.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653434|NCT01656408|3042425|Superiority or Other||LS Mean Difference|-4.2|Standard Error of the Mean|3.0||0.169|2-Sided|90.0|-9.3|0.9|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653435|NCT01656408|3042425|Superiority or Other||LS Mean Difference|3.5|Standard Error of the Mean|4.9||0.484|2-Sided|90.0|-4.9|11.9|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 10|
1653436|NCT01656408|3042425|Superiority or Other||LS Mean Difference|-7.4|Standard Error of the Mean|3.2||0.03|2-Sided|90.0|-13.0|-1.9|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653437|NCT01656408|3042425|Superiority or Other||LS Mean Difference|-14.1|Standard Error of the Mean|3.3||0|2-Sided|90.0|-19.8|-8.4|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653438|NCT01656408|3042425|Superiority or Other||LS Mean Difference|-9.9|Standard Error of the Mean|3.2||0.005|2-Sided|90.0|-15.4|-4.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653439|NCT01656408|3042425|Superiority or Other||Least Squares (LS) Mean Difference|0.1|Standard Error of the Mean|3.8||0.978|2-Sided|90.0|-6.4|6.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo|Day 1|
1653440|NCT01656395|3042428|Superiority||Mean Difference (Final Values)|-0.309||||0.503|2-Sided|95.0|-1.219|0.6|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: Montelukast vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653441|NCT01656395|3042428|Superiority||Mean Difference (Final Values)|0.079||||0.865|2-Sided|95.0|-0.839|0.997|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 150 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653442|NCT01656395|3042428|Superiority||Mean Difference (Final Values)|-0.54||||0.27|2-Sided|95.0|-1.504|0.423|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 60 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653443|NCT01656395|3042428|Superiority||Mean Difference (Final Values)|-0.376||||0.437|2-Sided|95.0|-1.326|0.575|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 30 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653444|NCT01656395|3042428|Superiority||Mean Difference (Final Values)|-0.075||||0.873|2-Sided|95.0|-1.004|0.853|||ANOVA|||Difference in LS means for percent of asthma attack days over Week 6 to Week 12 of a 12-week treatment period: MK-1209 10 mg vs. Placebo. ANOVA model includes terms for prior ICS use (Yes/No) and treatment. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).|
1653445|NCT01656395|3042429|Superiority||Mean Difference (Final Values)|2.3||||0.8032|2-Sided|95.0|-16.0|20.5|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).|
1653446|NCT01656395|3042429|Superiority||Mean Difference (Final Values)|8.1||||0.3934|2-Sided|95.0|-10.6|26.2|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).|
1653447|NCT01656395|3042429|Superiority||Mean Difference (Final Values)|3.8||||0.6991|2-Sided|95.0|-15.6|22.6|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).|
1653448|NCT01656395|3042429|Superiority||Mean Difference (Final Values)|-3.4||||0.7248|2-Sided|95.0|-22.1|15.4|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).|
1653449|NCT01656395|3042429|Superiority||Mean Difference (Final Values)|3.1||||0.742|2-Sided|95.0|-15.1|21.1|||MN method|||Difference for change from Baseline to Week 12 in ACQ response rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).|
1653450|NCT01656395|3042430|Superiority||Mean Difference (Final Values)|-0.227||||0.257|2-Sided|95.0|-0.621|0.166|||cLDA model|||"Difference in LS means for change from Baseline to Week 12 in ACQ Score: Montelukast vs. Placebo.~cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast)."|
1653451|NCT01656395|3042430|Superiority||Mean Difference (Final Values)|-0.362||||0.079|2-Sided|95.0|-0.767|0.042|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653452|NCT01656395|3042430|Superiority||Mean Difference (Final Values)|-0.151||||0.476|2-Sided|95.0|-0.568|0.265|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653453|NCT01656395|3042430|Superiority||Mean Difference (Final Values)|-0.032||||0.875|2-Sided|95.0|-0.436|0.372|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653454|NCT01656395|3042430|Superiority||Mean Difference (Final Values)|-0.104||||0.603|2-Sided|95.0|-0.495|0.288|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in ACQ Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653455|NCT01656395|3042431|Superiority||Mean Difference (Final Values)|18.2||||0.0555|2-Sided|95.0|-0.4|35.5|||MN method|||Difference for AQLQ(S) Response Rate: Montelukast vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).|
1653456|NCT01656395|3042431|Superiority||Mean Difference (Final Values)|17.5||||0.0774|2-Sided|95.0|-1.9|35.7|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 150 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).|
1653457|NCT01656395|3042431|Superiority||Mean Difference (Final Values)|10.5||||0.3003|2-Sided|95.0|-9.4|29.6|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 60 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).|
1653458|NCT01656395|3042431|Superiority||Mean Difference (Final Values)|-6.6||||0.4943|2-Sided|95.0|-24.9|12.2|||MN Method|||Difference for AQLQ(S) Response Rate: MK-1029 30 mg vs. Placebo. P-values, estimates and 95% CIs are based on the MN method stratified by prior ICS use (Yes/No).|
1653459|NCT01656395|3042431|Superiority||Mean Difference (Final Values)|2.8||||0.7687|2-Sided|95.0|-16.0|21.3|||MN method|||Difference for AQLQ(S) Response Rate: MK-1029 10 mg vs. Placebo. P-values, estimates and 95% confidence intervals (CIs) are based on the Miettinen and Nurminen (MN) method stratified by prior ICS use (Yes/No).|
1653460|NCT01656395|3042432|Superiority||Mean Difference (Final Values)|0.319||||0.086|2-Sided|95.0|-0.045|0.683|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).|
1653461|NCT01656395|3042432|Superiority||Mean Difference (Final Values)|0.375||||0.051|2-Sided|95.0|-0.001|0.751|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653462|NCT01656395|3042432|Superiority||Mean Difference (Final Values)|0.165||||0.403|2-Sided|95.0|-0.222|0.552|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653463|NCT01656395|3042432|Superiority||Mean Difference (Final Values)|-0.047||||0.807|2-Sided|95.0|-0.422|0.329|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653464|NCT01656395|3042432|Superiority||Mean Difference (Final Values)|0.076||||0.682|2-Sided|95.0|-0.288|0.44|||cLDA model|||Difference in LS means for change from Baseline to Week 12 in AQLQ(S) Overall Score: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653465|NCT01656395|3042433|Superiority||Mean Difference (Final Values)|-1.604||||0.876|2-Sided|95.0|-21.76|18.554|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653466|NCT01656395|3042433|Superiority||Mean Difference (Final Values)|5.114||||0.618|2-Sided|95.0|-15.04|25.272|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653765|NCT01649375|3043096|Superiority||Odds Ratio (OR)|4.28||||0.0325|2-Sided|95.0|1.13|16.21|||Regression, Logistic|Missing ASAS responses considered nonresponders|||
1653467|NCT01656395|3042433|Superiority||Median Difference (Final Values)|9.575||||0.374|2-Sided|95.0|-11.62|30.766|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653468|NCT01656395|3042433|Superiority||Mean Difference (Final Values)|6.251||||0.559|2-Sided|95.0|-14.81|27.307|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK- 1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653469|NCT01656395|3042433|Superiority||Mean Difference (Final Values)|0.544||||0.958|2-Sided|95.0|-19.92|21.007|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in AM/PM PEF: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653470|NCT01656395|3042434|Superiority||Mean Difference (Final Values)|-0.071||||0.863|2-Sided|95.0|-0.883|0.741|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653471|NCT01656395|3042434|Superiority||Mean Difference (Final Values)|-0.241||||0.559|2-Sided|95.0|-1.053|0.571|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653472|NCT01656395|3042434|Superiority||cLDA model|-0.251||||0.563|2-Sided|95.0|-1.104|0.603|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653473|NCT01656395|3042434|Superiority||Mean Difference (Final Values)|0.135||||0.754|2-Sided|95.0|-0.713|0.983|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653474|NCT01656395|3042434|Superiority||Mean Difference (Final Values)|-0.241||||0.565|2-Sided|95.0|-1.066|0.583|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in nocturnal awakenings: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653475|NCT01656395|3042435|Superiority||Mean Difference (Final Values)|-0.389||||0.237|2-Sided|95.0|-1.035|0.257|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653476|NCT01656395|3042435|Superiority||Mean Difference (Final Values)|0.275||||0.403|2-Sided|95.0|-0.371|0.921|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653477|NCT01656395|3042435|Superiority||Mean Difference (Final Values)|-0.11||||0.75|2-Sided|95.0|-0.789|0.569|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653478|NCT01656395|3042435|Superiority||Mean Difference (Final Values)|-0.075||||0.827|2-Sided|95.0|-0.75|0.6|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653479|NCT01656395|3042435|Superiority||Mean Difference (Final Values)|-0.528||||0.114|2-Sided|95.0|-1.184|0.128|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in SABA use: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use(Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653480|NCT01656395|3042436|Superiority||Mean Difference (Final Values)|-0.136||||0.372|2-Sided|95.0|-0.434|0.163|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653481|NCT01656395|3042436|Superiority||Mean Difference (Final Values)|0.156||||0.305|2-Sided|95.0|-0.142|0.454|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653482|NCT01656395|3042436|Superiority||Mean Difference (Final Values)|-0.089||||0.579|2-Sided|95.0|-0.402|0.225|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK- 1029 or Montelukast).|
1653766|NCT01649375|3043097|Superiority||Mean Difference (Net)|-2.63|Standard Error of the Mean|0.743||0.0005|2-Sided|95.0|-4.09|-1.16|||Mixed Models Analysis||||
1653483|NCT01656395|3042436|Superiority||Mean Difference (Final Values)|0.142||||0.37|2-Sided|95.0|-0.169|0.454|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653484|NCT01656395|3042436|Superiority||Mean Difference (Final Values)|-0.122||||0.429|2-Sided|95.0|-0.427|0.182|||cLDA model|||Difference in LS means for average change from Baseline to Week 12 in DSS: MK-1029 10 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653485|NCT01656395|3042437|Superiority||Mean Difference (Final Values)|-5.247||||0.308|2-Sided|95.0|-15.36|4.871|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: Montelukast vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653486|NCT01656395|3042437|Superiority||Mean Difference (Final Values)|-4.666||||0.367|2-Sided|95.0|-14.83|5.501|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 150 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653487|NCT01656395|3042437|Superiority||Mean Difference (Final Values)|-9.469||||0.083|2-Sided|95.0|-20.19|1.25|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 60 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653488|NCT01656395|3042437|Superiority||Mean Difference (Final Values)|-9.092||||0.092|2-Sided|95.0|-19.67|1.485|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 30 mg vs. Placebo. ANOVA model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653489|NCT01656395|3042437|Superiority||Mean Difference (Final Values)|-7.2||||0.169|2-Sided|95.0|-17.48|3.08|||ANOVA|||Difference in LS means for percent of asthma exacerbation day over Week 6 through Week 12: MK- 1029 10 mg vs. Placebo. Analysis of variance (ANOVA) model includes the terms for treatment groups and prior ICS use (Yes/No). Negative differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653490|NCT01656395|3042440|Superiority||Mean Difference (Final Values)|-0.004||||0.935|2-Sided|95.0|-0.109|0.1|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: Montelukast vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653491|NCT01656395|3042440|Superiority||Mean Difference (Final Values)|-0.008||||0.89|2-Sided|95.0|-0.115|0.1|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 150 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653492|NCT01656395|3042440|Superiority||Mean Difference (Final Values)|0.019||||0.733|2-Sided|95.0|-0.092|0.13|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 60 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653493|NCT01656395|3042440|Superiority||Mean Difference (Final Values)|-0.04||||0.477|2-Sided|95.0|-0.149|0.07|||cLDA model|||Difference in LS means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 30 mg vs. Placebo. cLDA model includes terms for visit as categorical variable, prior ICS use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653494|NCT01656395|3042440|Superiority||Mean Difference (Final Values)|0.022||||0.685|2-Sided|95.0|-0.084|0.127|||cLDA model|||Difference in least squares (LS) means for average change from Baseline over Week 6 to Week 12 in FEV1: MK-1029 10 mg vs. Placebo. Constrained longitudinal data analysis (cLDA) model includes terms for visit as categorical variable, prior inhaled corticosteroid (ICS) use (Yes/No) and treatment by visit. Positive differences are in favor of the first treatment group in the comparison (MK-1029 or Montelukast).|
1653495|NCT01656304|3042446|Superiority or Other||Rate|0.333|Standard Error of the Mean|0.1217|||2-Sided|80.0|0.2|0.5|||||||
1653496|NCT01655069|3042513|Other||Adjusted change from baseline|-2.2|Standard Error of the Mean|0.65|||2-Sided|95.0|-3.48|-0.93||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653497|NCT01655069|3042513|Other||Adjusted change from baseline|-1.96|Standard Error of the Mean|0.49|||2-Sided|95.0|-2.93|-1.0||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653498|NCT01655069|3042513|Other||Adjusted change from baseline|-1.04|Standard Error of the Mean|0.46|||2-Sided|95.0|-1.95|-0.12||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"|
1653499|NCT01655069|3042513|Other||Adjusted change from baseline|-1.28|Standard Error of the Mean|0.46|||2-Sided|95.0|-2.18|-0.38||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653990|NCT01646177|3043411|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653500|NCT01655069|3042513|Other||Adjusted change from baseline|-1.14|Standard Error of the Mean|0.47|||2-Sided|95.0|-2.06|-0.22||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653501|NCT01655069|3042513|Other||Adjusted change from baseline|-1.3|Standard Error of the Mean|0.47|||2-Sided|95.0|-2.23|-0.36||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653502|NCT01655069|3042513|Other||Adjusted change from baseline|-0.74|Standard Error of the Mean|0.46|||2-Sided|95.0|-1.65|0.17||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653503|NCT01655069|3042514|Other||Adjusted change from baseline|-1.79|Standard Error of the Mean|0.38|||2-Sided|95.0|-2.59|-1.0||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653504|NCT01655069|3042514|Other||Adjusted change from baseline|-1.18|Standard Error of the Mean|0.36|||2-Sided|95.0|-1.92|-0.44||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653505|NCT01655069|3042514|Other||Adjusted change from baseline|-0.71|Standard Error of the Mean|0.52|||2-Sided|95.0|-1.8|-0.38||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653506|NCT01655069|3042514|Other||Adjusted change from baseline|-0.91|Standard Error of the Mean|0.3|||2-Sided|95.0|-1.53|-0.28||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653507|NCT01655069|3042514|Other||Adjusted change from baseline|-0.81|Standard Error of the Mean|0.31|||2-Sided|95.0|-1.46|-0.17||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653508|NCT01655069|3042514|Other||Adjusted change from baseline|-0.94|Standard Error of the Mean|0.26|||2-Sided|95.0|-1.48|-0.4||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653509|NCT01655069|3042514|Other||Adjusted change from baseline|-0.93|Standard Error of the Mean|0.39|||2-Sided|95.0|-1.73|-0.13||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653510|NCT01655069|3042514|Other||Adjusted change from baseline|-1.83|Standard Error of the Mean|0.2|||2-Sided|95.0|-2.22|-1.43||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653511|NCT01655069|3042514|Other||Adjusted change from baseline|-1.52|Standard Error of the Mean|0.16|||2-Sided|95.0|-1.83|-1.22||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653512|NCT01655069|3042514|Other||Adjusted change from baseline|-1.5|Standard Error of the Mean|0.15|||2-Sided|95.0|-1.8|-1.21||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653513|NCT01655069|3042514|Other||Adjusted change from baseline|-1.22|Standard Error of the Mean|0.15|||2-Sided|95.0|-1.51|-0.93||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"|
1653514|NCT01655069|3042514|Other||Adjusted change from baseline|-1.31|Standard Error of the Mean|0.15|||2-Sided|95.0|-1.6|-1.02||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"|
1653515|NCT01655069|3042514|Other||Adjusted change from baseline|-1.15|Standard Error of the Mean|0.15|||2-Sided|95.0|-1.44|-0.86||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"|
1653761|NCT01649596|3043074|Superiority or Other||percent|48.0|||<|0.05|2-Sided||||||t-test, 2 sided|A t-test for percents was used to compare the number of participants (%) from each group reporting satisfaction (somewhat and highly satisfied).|||
1653516|NCT01655069|3042514|Other||Adjusted change from baseline|-0.98|Standard Error of the Mean|0.15|||2-Sided|95.0|-1.27|-0.69||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653517|NCT01655069|3042515|Other||Adjusted change from baseline|3.93|Standard Error of the Mean|0.81|||2-Sided|95.0|2.34|5.53||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653518|NCT01655069|3042515|Other||Adjusted change from baseline|2.45|Standard Error of the Mean|0.71|||2-Sided|95.0|1.05|3.85||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653519|NCT01655069|3042515|Other||Adjusted change from baseline|3.07|Standard Error of the Mean|0.69|||2-Sided|95.0|1.7|4.43||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653520|NCT01655069|3042515|Other||Adjusted change from baseline|2.69|Standard Error of the Mean|0.69|||2-Sided|95.0|1.34|4.05||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653521|NCT01655069|3042515|Other||Adjusted change from baseline|1.75|Standard Error of the Mean|0.69|||2-Sided|95.0|0.39|3.1||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653522|NCT01655069|3042515|Other||Adjusted change from baseline|1.9|Standard Error of the Mean|0.7|||2-Sided|95.0|0.52|3.27||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653523|NCT01655069|3042515|Other||Adjusted change from baseline|1.53|Standard Error of the Mean|0.69|||2-Sided|95.0|0.17|2.89||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653524|NCT01655069|3042515|Other||Adjusted change from baseline|2.84|Standard Error of the Mean|0.33|||2-Sided|95.0|2.19|3.49||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653525|NCT01655069|3042515|Other||Adjusted change from baseline|2.28|Standard Error of the Mean|0.25|||2-Sided|95.0|1.79|2.77||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653526|NCT01655069|3042515|Other||Adjusted change from baseline|2.21|Standard Error of the Mean|0.23|||2-Sided|95.0|1.74|2.67||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653527|NCT01655069|3042515|Other||Adjusted change from baseline|1.8|Standard Error of the Mean|0.22|||2-Sided|95.0|1.36|2.24||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653528|NCT01655069|3042515|Other||Adjusted change from baseline|1.72|Standard Error of the Mean|0.22|||2-Sided|95.0|1.27|2.16||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653529|NCT01655069|3042515|Other||Adjusted change from baseline|1.43|Standard Error of the Mean|0.2|||2-Sided|95.0|1.02|1.83||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653530|NCT01655069|3042515|Other||Adjusted change from baseline|1.35|Standard Error of the Mean|0.19|||2-Sided|95.0|0.97|1.73||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653531|NCT01655069|3042516|Other||Adjusted change from baseline|-2.0|Standard Error of the Mean|0.42|||2-Sided|95.0|-2.83|-1.17||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653762|NCT01649596|3043075|Superiority or Other||percent|10.0||||0.12|2-Sided||||||Chi-squared||||
1653763|NCT01649427|3043095|Non-Inferiority or Equivalence|Non-inferiority||||||0.0003|||||||ANCOVA||||
1653532|NCT01655069|3042516|Other||Adjusted change from baseline|-1.57|Standard Error of the Mean|0.36|||2-Sided|95.0|-2.29|-0.85||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653533|NCT01655069|3042516|Other||Adjusted change from baseline|-1.8|Standard Error of the Mean|0.35|||2-Sided|95.0|-2.5|-1.1||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653534|NCT01655069|3042516|Other||Adjusted change from baseline|-1.58|Standard Error of the Mean|0.35|||2-Sided|95.0|-2.27|-0.88||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653535|NCT01655069|3042516|Other||Adjusted change from baseline|-1.4|Standard Error of the Mean|0.35|||2-Sided|95.0|-2.09|-0.7||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653536|NCT01655069|3042516|Other||Adjusted change from baseline|-1.38|Standard Error of the Mean|0.36|||2-Sided|95.0|-2.09|-0.68||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"|
1653537|NCT01655069|3042516|Other||Adjusted change from baseline|-0.93|Standard Error of the Mean|0.35|||2-Sided|95.0|-1.62|-0.23||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653538|NCT01655069|3042516|Other||Adjusted change from baseline|-1.93|Standard Error of the Mean|0.13|||2-Sided|95.0|-2.19|-1.67||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653539|NCT01655069|3042516|Other||Adjusted change from baseline|-1.56|Standard Error of the Mean|0.13|||2-Sided|95.0|-1.81|-1.31||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant"|
1653540|NCT01655069|3042516|Other||Adjusted change from baseline|-1.54|Standard Error of the Mean|0.11|||2-Sided|95.0|-1.76|-1.32||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653541|NCT01655069|3042516|Other||Adjusted change from baseline|-1.39|Standard Error of the Mean|0.12|||2-Sided|95.0|-1.63|-1.16||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653542|NCT01655069|3042516|Other||Adjusted change from baseline|-1.26|Standard Error of the Mean|0.13|||2-Sided|95.0|-1.53|-1.0||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653543|NCT01655069|3042516|Other||Adjusted change from baseline|-1.11|Standard Error of the Mean|0.12|||2-Sided|95.0|-1.34|-0.88||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653544|NCT01655069|3042516|Other||Adjusted change from baseline|-0.95|Standard Error of the Mean|0.12|||2-Sided|95.0|-1.19|-0.71||||||"Repeated measures ANCOVA (analysis of covariance) was used in this analysis, which included double-blind and/or open-label solifenacin treatment duration, gender, geographic region and randomized treatment group in Study 905-CL-076 as fixed effects, baseline as a covariate and duration repeated within participant."|
1653545|NCT01654549|3042544|Superiority or Other|||||||0.1|||||||t-test, 2 sided||||
1653546|NCT01654549|3042544|Superiority or Other||||||<|0.01|||||||Paired t-test||||
1653547|NCT01654549|3042544|Superiority or Other||||||<|0.01|||||||Paired t-test||||
1653548|NCT01654549|3042544|Superiority or Other||||||<|0.78|||||||t-test, 2 sided||||
1653549|NCT01654549|3042544|Superiority or Other||||||<|0.94|||||||t-test, 2 sided||||
1653550|NCT01654523|3042561|Superiority or Other||Mean change in the single arm trial|6.695|Standard Deviation|5.505|<|0.05|2-Sided|95.0|4.041|9.348|||Paired t-test||||
1653551|NCT01654276|3042586|Superiority or Other|||||||0.66|||||||t-test, 2 sided||||
1653552|NCT01654250|3042602|Superiority or Other||LS Mean difference|8.3|Standard Error of the Mean|11.44||0.466|2-Sided|95.0|-14.1|30.8|||Mixed Models Analysis|||Hour 13 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653764|NCT01649375|3043096|Superiority||Odds Ratio (OR)|3.91||||0.0471|2-Sided|95.0|1.02|15.01|||Regression, Logistic|Missing ASAS responses considered nonresponders|||
1653991|NCT01646177|3043412|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653553|NCT01654250|3042602|Superiority or Other||LS Mean Difference|9.8|Standard Error of the Mean|11.44||0.394|2-Sided|95.0|-12.7|32.2|||Mixed Models Analysis|||Hour 12 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653554|NCT01654250|3042602|Superiority or Other||LS Mean difference|8.6|Standard Error of the Mean|11.44||0.451|2-Sided|95.0|-13.9|31.1|||Mixed Models Analysis|||Hour 10 (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653555|NCT01654250|3042602|Superiority or Other||LS Mean Difference|27.0|Standard Error of the Mean|11.44||0.019|2-Sided|95.0|4.5|49.5|||Mixed Models Analysis|||Hour 8 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653556|NCT01654250|3042602|Superiority or Other||LS Mean Difference|32.9|Standard Error of the Mean|11.44||0.004|2-Sided|95.0|10.5|55.4|||Mixed Models Analysis|||Hour 4 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653557|NCT01654250|3042602|Superiority or Other||LS Mean Difference|34.4|Standard Error of the Mean|11.44||0.003|2-Sided|95.0|11.9|56.9|||Mixed Models Analysis|||Hour 2 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653558|NCT01654250|3042602|Superiority or Other||LS Mean Difference|22.6|Standard Error of the Mean|11.44||0.049|2-Sided|95.0|0.1|45.1|||Mixed Models Analysis|||Hour 0.75 post-dose (Problems correct): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653559|NCT01654250|3042602|Superiority or Other||LS Mean Difference|18.7|Standard Error of the Mean|11.12||0.094|2-Sided|95.0|-3.2|40.5|||Mixed Models Analysis|||Hour 13 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653560|NCT01654250|3042602|Superiority or Other||LS Mean Difference|15.1|Standard Error of the Mean|11.12||0.175|2-Sided|95.0|-6.7|37.0|||Mixed Models Analysis|||Hour 12 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653561|NCT01654250|3042602|Superiority or Other||LS Mean Difference|12.5|Standard Error of the Mean|11.12||0.261|2-Sided|95.0|-9.3|34.4|||Mixed Models Analysis|||Hour 10 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653562|NCT01654250|3042602|Superiority or Other||LS Mean Difference|29.3|Standard Error of the Mean|11.12||0.009|2-Sided|95.0|7.4|51.1|||Mixed Models Analysis|||Hour 8 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653563|NCT01654250|3042602|Superiority or Other||LS Mean Difference|34.7|Standard Error of the Mean|11.12||0.002|2-Sided|95.0|12.8|56.6|||Mixed Models Analysis|||Hour 4 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653564|NCT01654250|3042602|Superiority or Other||LS Mean Difference|36.1|Standard Error of the Mean|11.12||0.001|2-Sided|95.0|14.2|57.9|||Mixed Models Analysis|||Hour 2 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653565|NCT01654250|3042602|Superiority or Other||LS Mean difference|25.3|Standard Error of the Mean|11.12||0.024|2-Sided|95.0|3.4|47.1|||Mixed Models Analysis|||Hour 0.75 post-dose (Problems attempted): Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653566|NCT01654250|3042603|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.94||0.962|2-Sided|95.0|-1.8|1.9|||Mixed Models Analysis|||Hour 13 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653567|NCT01654250|3042603|Superiority or Other||LS Mean Difference|-0.9|Standard Error of the Mean|0.94||0.342|2-Sided|95.0|-2.7|1.9|||Mixed Models Analysis|||Hour 12 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653605|NCT01654224|3042607|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.006||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided||||
1653568|NCT01654250|3042603|Superiority or Other||LS Mean Difference|-1.5|Standard Error of the Mean|0.94||0.118|2-Sided|95.0|-3.3|0.4|||Mixed Models Analysis|||Hour 10 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653569|NCT01654250|3042603|Superiority or Other||LS Mean Difference|-1.9|Standard Error of the Mean|0.94||0.042|2-Sided|95.0|-3.8|-0.1|||Mixed Models Analysis|||Hour 8 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653570|NCT01654250|3042603|Superiority or Other||LS Mean Difference|-3.9|Standard Error of the Mean|0.94|<|0.001|2-Sided|95.0|-5.8|-2.1|||Mixed Models Analysis|||Hour 4 post-dose deportment sub scale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653571|NCT01654250|3042603|Superiority or Other||LS Mean difference|-3.9|Standard Error of the Mean|0.94|<|0.001|2-Sided|95.0|-5.8|-2.1|||Mixed Models Analysis|||Hour 2 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653572|NCT01654250|3042603|Superiority or Other||LS Mean Difference|-2.7|Standard Error of the Mean|0.94|<|0.004|2-Sided|95.0|-4.6|-0.9|||Mixed Models Analysis|||Hour 0.75 post-dose deportment subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653573|NCT01654250|3042603|Superiority or Other||LS Mean Difference|-0.8|Standard Error of the Mean|0.56|<|0.164|2-Sided|95.0|-1.9|0.3|||Mixed Models Analysis|||Hour 13 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653574|NCT01654250|3042603|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.56|<|0.49|2-Sided|95.0|-1.5|0.7|||Mixed Models Analysis|||Hour 12 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653575|NCT01654250|3042603|Superiority or Other||LS Mean Difference|-0.9|Standard Error of the Mean|0.56|<|0.097|2-Sided|95.0|-2.0|0.2|||Mixed Models Analysis|||Hour 10 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653576|NCT01654250|3042603|Superiority or Other||LS Mean Difference|-1.7|Standard Error of the Mean|0.56|<|0.003|2-Sided|95.0|-2.8|-0.6|||Mixed Models Analysis|||Hour 8 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653577|NCT01654250|3042603|Superiority or Other||LS Mean Difference|-2.3|Standard Error of the Mean|0.56|<|0.001|2-Sided|95.0|-3.4|-1.2|||Mixed Models Analysis|||Hour 4 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653578|NCT01654250|3042603|Superiority or Other||LS Mean Difference|-2.5|Standard Error of the Mean|0.56|<|0.001|2-Sided|95.0|-3.6|-1.4|||Mixed Models Analysis|||Hour 2 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653579|NCT01654250|3042603|Superiority or Other||LS Mean Difference|-1.5|Standard Error of the Mean|0.56|<|0.007|2-Sided|95.0|-2.6|-0.4|||Mixed Models Analysis|||Hour 0.75 post-dose attention subscale: Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653580|NCT01654250|3042604|Superiority or Other|||||||0.133|||||||Mixed Models Analysis|||Hour 13 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.|
1653581|NCT01654250|3042604|Superiority or Other||LS Mean Difference|-1.6|Standard Error of the Mean|2.28||0.496|2-Sided|95.0|-6.0|2.9|||Mixed Models Analysis|||Hour 13 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653582|NCT01654250|3042604|Superiority or Other|||||||0.133|||||||Mixed Models Analysis|||Hour 12 post-dose: Adjusted p-values are generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.|
1653583|NCT01654250|3042604|Superiority or Other||LS Mean Difference|-2.9|Standard Error of the Mean|2.28||0.206|2-Sided|95.0|-7.4|1.6|||Mixed Models Analysis|||Hour 12 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653584|NCT01654250|3042604|Superiority or Other|||||||0.133|||||||Mixed Models Analysis|||Hour 10 post-dose: Adjusted p-value were generated using a fixed sequence testing procedure from p-values generated from the mixed effects model.|
1653634|NCT01652872|3042765|Other||Hazard Ratio (HR)|1.01|||||2-Sided|95.0|0.76|1.35|||||Hazard ratio is fixed dose relative to titration.||
1653585|NCT01654250|3042604|Superiority or Other||LS Mean Difference|-3.4|Standard Error of the Mean|2.28||0.133|2-Sided|95.0|-7.9|1.1|||Mixed Models Analysis|||Hour 10 post-dose: Nominal p-value -treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653586|NCT01654250|3042604|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Hour 8 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.|
1653587|NCT01654250|3042604|Superiority or Other||LS Mean Difference|-7.8|Standard Error of the Mean|2.28|<|0.001|2-Sided|95.0|-12.3|-3.3|||Mixed Models Analysis|||Hour 8 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effect and participant intercept as a random effect.|
1653588|NCT01654250|3042604|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Hour 4 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.|
1653589|NCT01654250|3042604|Superiority or Other||LS Mean Difference|-12.3|Standard Error of the Mean|2.28|<|0.001|2-Sided|95.0|-16.8|-7.8|||Mixed Models Analysis|||Hour 4 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653590|NCT01654250|3042604|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Hour 2 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.|
1653591|NCT01654250|3042604|Superiority or Other||LS Mean Difference|-12.8|Standard Error of the Mean|2.28|<|0.001|2-Sided|95.0|-17.3|-8.3|||Mixed Models Analysis|||Hour 2 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653592|NCT01654250|3042604|Superiority or Other||||||<|0.133|||||||Mixed Models Analysis|||Hour 0.75 post-dose: Adjusted p-values were generated using a fixed sequence testing procedure from p-values which were generated from the mixed effects model.|
1653593|NCT01654250|3042604|Superiority or Other||LS Mean Difference|-8.2|Standard Error of the Mean|2.28|<|0.001|2-Sided|95.0|-12.7|-3.7|||Mixed Models Analysis|||Hour 0.75 post-dose: Nominal p value-treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653594|NCT01654250|3042605|Superiority or Other||Least Square(LS) Mean Difference|-7.0|Standard Error of the Mean|1.99|<|0.001|2-Sided|95.0|-10.9|-3.1|||Mixed Models Analysis|||Treatment comparisons for observed scores were assessed using a mixed model repeated measures analysis, with treatment (NWP09/Placebo), study center, time point, and time point by treatment interaction as main effects and participant intercept as a random effect.|
1653595|NCT01654224|3042606|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.285||||||B/Texas/6/2011|t-test, 2 sided||||
1653596|NCT01654224|3042606|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.152||||||A/Victoria/361/2011(H1N2)|t-test, 2 sided||||
1653597|NCT01654224|3042606|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.178||||||A/California/07/2009(H1N1)|t-test, 2 sided||||
1653598|NCT01654224|3042606|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.248||||||B/Brisbane/60/2008|t-test, 2 sided||||
1653599|NCT01654224|3042606|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.36||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided||||
1653600|NCT01654224|3042606|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.917||||||A/California/07/2009(H1N1)|t-test, 2 sided||||
1653601|NCT01654224|3042607|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.063||||||B/Texas/6/2011|t-test, 2 sided||||
1653602|NCT01654224|3042607|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.003||||||A/Victoria/361/2011(H3N2)|t-test, 2 sided||||
1653603|NCT01654224|3042607|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.663||||||A/California/07/2009(H3N2)|t-test, 2 sided||||
1653604|NCT01654224|3042607|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.069||||||B/Brisbane/60/2008|t-test, 2 sided||||
1653726|NCT01651208|3042898|Superiority or Other||Mean Difference (Final Values)|0.29|||<|0.01|2-Sided||||||t-test, 2 sided|||The null hypothesis is that the mean MMAS-4 score is similar in both intervention arms|
1653606|NCT01654224|3042607|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.074||||||A/California/07/2009(H1N1)|t-test, 2 sided||||
1653607|NCT01654224|3042608|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.01||||||B/Texas/6/2011|t-test, 2 sided||||
1653608|NCT01654224|3042608|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.011||||||A/Victoria/361/2011(H3N2)|t-test, 2 sided||||
1653609|NCT01654224|3042608|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.672||||||A/California/07/2009(H1N1)|t-test, 2 sided||||
1653610|NCT01654224|3042608|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.004||||||B/Brisbane/60/2008|t-test, 2 sided||||
1653611|NCT01654224|3042608|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.001||||||A/Victoria/210/2009(H3N2)|t-test, 2 sided||||
1653612|NCT01654224|3042608|Non-Inferiority or Equivalence|An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority.||||||0.005||||||A/California/07/2009(H1N1)|t-test, 2 sided||||
1653613|NCT01653509|3042640|Superiority or Other||LS mean difference|0.37||||0.2446|2-Sided|95.0|-0.27|1.0|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for MEV.|
1653614|NCT01653509|3042640|Superiority or Other||LS mean difference|2.14||||0.179|2-Sided|95.0|-1.06|5.35|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV.|
1653615|NCT01653509|3042641|Superiority or Other||LS Mean Difference|0.38||||0.0799|2-Sided|95.0|-0.05|0.82|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for MEV.|
1653616|NCT01653509|3042641|Superiority or Other||LS Mean Difference|2.48||||0.0486|2-Sided|95.0|0.02|4.93|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV (Day 1 to day 10).|
1653617|NCT01653509|3042642|Superiority or Other||LS Mean Difference|-150.99||||0.4035|2-Sided|95.0|-517.97|215.99|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between treatments for MEV.|
1653618|NCT01653509|3042642|Superiority or Other||Least square mean difference|-911.48||||0.3061|2-Sided|95.0|-2712.65|889.69|||ANOVA|ANOVA model with a factor for treatment group.|Difference calculated as first named treatment minus second named treatment, such that a negative difference favours the first named treatment.|Null hypothesis considered no difference between study treatments for TEV.|
1653619|NCT01653405|3042652|Superiority|||||||0.002|||||||difference in differences||||
1653620|NCT01653405|3042653|Superiority||||||<|0.001|||||||Difference in differences||||
1653621|NCT01653405|3042654|Superiority||||||<|0.001|||||||difference in differences||||
1653622|NCT01653405|3042655|Superiority|||||||0.43|||||||test of differences||||
1653623|NCT01653405|3042656|Superiority||||||<|0.001|||||||Difference in differences||||
1653624|NCT01653327|3042657|Superiority|||||||0.3522|||||||t-test, 2 sided||||
1653625|NCT01653327|3042658|Superiority|||||||0.3198|||||||t-test, 2 sided||||
1653626|NCT01653210|3042675|Superiority or Other (legacy)|||||||0.023|||||||ANOVA||||
1653627|NCT01653132|3042721|Superiority or Other||Risk Difference (RD)|-0.11|||||2-Sided|95.0|-0.46|0.28|||||||
1653628|NCT01653132|3042722|Superiority or Other||Risk Difference (RD)|-0.333|||||2-Sided|95.0|-0.633|0.071|||||||
1653629|NCT01653132|3042723|Superiority or Other||Median Difference (Net)|-0.33|Standard Deviation|1.41|||2-Sided|95.0|-1.16|0.69|||||negative values represent reduction in scores (improvement in drooling) with Inco-A||
1653630|NCT01653132|3042724|Superiority or Other||Mean Difference (Net)|-22.3|Standard Deviation|0.34|||2-Sided|95.0|-50.8|6.2|||||negative numbers represent reduction in saliva weight with Inco-A||
1653631|NCT01653132|3042725|Superiority or Other||Mean Difference (Net)|-0.194|Standard Deviation|0.61|||2-Sided|95.0|-0.71|0.32|||||negative values correspond to a reduction in saliva weight with Inco-A.|Based on the primary outcome measure of mean reduction in saliva weight at 1 month post Inco-A /placebo as compared to baseline, using paired t-test with a two-sided nominal significance (alpha) of 0.05, assuming a correlation of 0.5 between observations, a sample size of 10 pairs has a power of 0.803 to detect a 50% difference in salivary weight.|
1653632|NCT01652872|3042763|Other||Median of the difference|-22.1|||||2-Sided|95.0|-26.1|-18.1|||||Difference is fixed dose - titration.||The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.
1653633|NCT01652872|3042764|Other||Median of the difference|-0.34|||||2-Sided|95.0|-0.46|-0.22|||||Difference is fixed dose - titration.||The 2-sided 95% confidence intervals were obtained using a non-parametric Wilcoxon rank-sum statistic.
1653992|NCT01646177|3043412|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653635|NCT01652872|3042766|Other|Stratified by RBC transfusion received within 12 months prior to randomization (yes/no) and site practice setting (nephrology/non-nephrology) and accounting for participant exposure time.|Least Squares Mean (LSM) Ratio|1.28|||||2-Sided|95.0|0.81|2.05|||||Least Squares Mean (LSM) ratio is fixed dose relative to titration.||
1653636|NCT01652872|3042767|Other||Risk Ratio (RR)|0.998|||||2-Sided|95.0|0.776|1.285|||||A risk ratio < 1.0 indicates a lower event rate for the fixed dose group relative to Hb-based titration group.||
1653637|NCT01652872|3042767|Other||Treatment Difference|-0.27|||||2-Sided|95.0|-6.39|5.85|||||Difference is fixed dose - titration.||
1653638|NCT01652729|3042768|Superiority or Other||LS Mean Difference|-20.89|Standard Error of the Mean|19.66||0.2914|2-Sided|95.0|-60.02|18.25||Nominal p-value|general linear model|Includes treatment and baseline HbA1c (< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.|||
1653639|NCT01652729|3042768|Superiority or Other||LS Mean Difference|-35.96|Standard Error of the Mean|15.71||0.0248|2-Sided|95.0|-67.23|-4.68||Nominal p-value|general linear model|Includes treatment and baseline HbA1c (< 9% or ≥ 9%) as fixed factors, and baseline 2-hour postprandial plasma glucose concentrations as a covariate.|||
1653640|NCT01652729|3042769|Superiority or Other||LS Mean Difference|-1.27|Standard Error of the Mean|0.5419||0.0198|2-Sided|95.0|-2.34|-0.2||Nominal p-value|mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.|||
1653641|NCT01652729|3042769|Superiority or Other||LS Mean Difference|0.07|Standard Error of the Mean|0.4058||0.8625|2-Sided|95.0|-0.73|0.87||Nominal p-value|mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.|||
1653642|NCT01652729|3042770|Superiority or Other||LS Mean Difference|-30.9|Standard Error of the Mean|8.037||0.0001|2-Sided|95.0|-46.7|-15.1|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.|||
1653643|NCT01652729|3042770|Superiority or Other||LS Mean Difference|-10.1|Standard Error of the Mean|5.96||0.0924|2-Sided|95.0|-21.8|1.7|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.|||
1653644|NCT01652729|3042771|Superiority or Other|||||||0.0103|||||||Cochran-Mantel-Haenszel|||Percentage of Subjects Achieving HbA1c <7% at Week 28.|
1653645|NCT01652729|3042771|Superiority or Other|||||||0.0489|||||||Cochran-Mantel-Haenszel|||Percentage of Subjects Achieving HbA1c <7% at Week 28.|
1653646|NCT01652729|3042772|Superiority or Other||LS Mean Difference|-0.34|Standard Error of the Mean|0.2278||0.1347|2-Sided|95.0|-0.79|0.11|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.|||
1653647|NCT01652729|3042772|Superiority or Other||LS Mean Difference|-0.38|Standard Error of the Mean|0.1638||0.0209|2-Sided|95.0|-0.7|-0.06|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.|||
1653648|NCT01652729|3042772|Superiority or Other||LS Mean Difference|-0.72|Standard Error of the Mean|0.2167||0.001|2-Sided|95.0|-1.15|-0.3|||mixed model for repeated measure|MMRM includes treatment, baseline HbA1c (<9% or ≥9%), week of visit and treatment by visit interaction as fixed factors, and subject random effect.|||
1653649|NCT01652716|3042773|Superiority or Other||LS Mean Difference|26.74|Standard Error of the Mean|15.8957||0.0985|2-Sided|95.0|-5.16|58.64|||Cochran-Mantel-Haenszel||||
1653650|NCT01652716|3042774|Superiority or Other||LS Mean Difference|0.4|Standard Error of the Mean|0.4497||0.3744|2-Sided|95.0|-0.48|1.28|||Cochran-Mantel-Haenszel||||
1653651|NCT01652716|3042775|Superiority or Other||LS Mean Difference|-10.2|Standard Error of the Mean|5.841||0.1656|2-Sided|95.0|-21.7|1.3||Adjusted|Cochran-Mantel-Haenszel||||
1653652|NCT01652716|3042776|Superiority or Other|||||||0.2247|||||||Cochran-Mantel-Haenszel||||
1653653|NCT01652716|3042777|Superiority or Other||LS Mean Difference|-0.37|Standard Error of the Mean|0.1349||0.0072|2-Sided|95.0|-0.63|-0.1|||Mixed model for repeated measure (MMRM)|Based on a repeated measures mixed model including fixed categorical effects of treatment|||
1653654|NCT01652703|3042778|Superiority or Other||LS Mean Treatment Difference|-52.22|Standard Error of the Mean|3.06|<|0.001|2-Sided|95.0|-58.27|-46.18||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653655|NCT01652703|3042778|Superiority or Other||LS Mean Treatment Difference|-57.75|Standard Error of the Mean|3.03|<|0.001|2-Sided|95.0|-63.73|-51.77||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653656|NCT01652703|3042778|Superiority or Other||LS Mean Treatment Difference|-47.53|Standard Error of the Mean|2.98|<|0.001|2-Sided|95.0|-53.41|-41.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653657|NCT01652703|3042778|Superiority or Other||LS Mean Treatment Difference|-61.35|Standard Error of the Mean|2.93|<|0.001|2-Sided|95.0|-67.14|-55.56||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653658|NCT01652703|3042779|Superiority or Other||LS Mean Treatment Difference|-45.3|Standard Error of the Mean|2.89|<|0.001|2-Sided|95.0|-51.02|-39.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653659|NCT01652703|3042779|Superiority or Other||LS Mean Treatment Difference|-46.66|Standard Error of the Mean|2.86|<|0.001|2-Sided|95.0|-52.32|-41.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653660|NCT01652703|3042779|Superiority or Other||LS Mean Treatment Difference|-37.22|Standard Error of the Mean|2.68|<|0.001|2-Sided|95.0|-42.52|-31.91||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653661|NCT01652703|3042779|Superiority or Other||LS Mean Treatment Difference|-46.98|Standard Error of the Mean|2.64|<|0.001|2-Sided|95.0|-52.21|-41.76||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653662|NCT01652703|3042780|Superiority or Other||LS Mean Treatment Difference|-20.82|Standard Error of the Mean|9.41||0.028|2-Sided|95.0|-39.41|-2.22||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653663|NCT01652703|3042780|Superiority or Other||LS Mean Treatment Difference|-29.82|Standard Error of the Mean|9.36||0.002|2-Sided|95.0|-48.32|-11.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653664|NCT01652703|3042780|Superiority or Other||LS Mean Treatment Difference|-24.25|Standard Error of the Mean|11.93||0.044|2-Sided|95.0|-47.83|-0.68||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653665|NCT01652703|3042780|Superiority or Other||LS Mean Treatment Difference|-34.49|Standard Error of the Mean|11.75||0.004|2-Sided|95.0|-57.71|-11.26||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653666|NCT01652703|3042781|Superiority or Other||LS Mean Treatment Difference|-47.37|Standard Error of the Mean|2.8|<|0.001|2-Sided|95.0|-52.9|-41.85||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653667|NCT01652703|3042781|Superiority or Other||LS Mean Treatment Difference|-53.44|Standard Error of the Mean|2.77|<|0.001|2-Sided|95.0|-58.91|-47.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653668|NCT01652703|3042781|Superiority or Other||LS Mean Treatment Difference|-46.75|Standard Error of the Mean|2.56|<|0.001|2-Sided|95.0|-51.8|-41.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653669|NCT01652703|3042781|Superiority or Other||LS Mean Treatment Difference|-60.69|Standard Error of the Mean|2.52|<|0.001|2-Sided|95.0|-65.67|-55.72||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653670|NCT01652703|3042782|Superiority or Other||LS Mean Treatment Difference|-53.54|Standard Error of the Mean|2.99|<|0.001|2-Sided|95.0|-59.46|-47.63||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653671|NCT01652703|3042782|Superiority or Other||LS Mean Treatment Difference|-58.08|Standard Error of the Mean|2.96|<|0.001|2-Sided|95.0|-63.93|-52.22||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653672|NCT01652703|3042782|Superiority or Other||LS Mean Treatment Difference|-49.46|Standard Error of the Mean|2.72|<|0.001|2-Sided|95.0|-54.83|-44.08||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653673|NCT01652703|3042782|Superiority or Other||LS Mean Treatment Difference|-62.56|Standard Error of the Mean|2.68|<|0.001|2-Sided|95.0|-67.85|-57.27||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653674|NCT01652703|3042783|Superiority or Other||Odds Ratio (OR)|595.59|||<|0.001|2-Sided|95.0|31.11|11402.67||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.|Placebo is the reference||
1653675|NCT01652703|3042783|Superiority or Other||Odds Ratio (OR)|536.45|||<|0.001|2-Sided|95.0|28.37|10143.4||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q4W and stratification factor of screening LDL-C level.|Placebo is the reference||
1653676|NCT01652703|3042783|Superiority or Other||Odds Ratio (OR)|281.13|||<|0.001|2-Sided|95.0|14.74|5360.92||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.|Placebo is the reference||
1653677|NCT01652703|3042783|Superiority or Other||Odds Ratio (OR)|1945.68|||<|0.001|2-Sided|95.0|89.64|42232.63||Testing based on a significance level of 0.05.|Regression, Logistic|Logistic Regression model includes treatment arms in dose frequency of Q2W and stratification factor of screening LDL-C level.|Placebo is the reference||
1653678|NCT01652703|3042784|Superiority or Other||LS Mean Treatment Difference|-80.7|Standard Error of the Mean|4.7|<|0.001|2-Sided|95.0|-90.0|-71.4||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653679|NCT01652703|3042784|Superiority or Other||LS Mean Treatment Difference|-88.2|Standard Error of the Mean|4.7|<|0.001|2-Sided|95.0|-97.4|-79.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653680|NCT01652703|3042784|Superiority or Other||LS Mean Treatment Difference|-75.5|Standard Error of the Mean|5.0|<|0.001|2-Sided|95.0|-85.4|-65.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653681|NCT01652703|3042784|Superiority or Other||LS Mean Treatment Difference|-96.3|Standard Error of the Mean|4.9|<|0.001|2-Sided|95.0|-106.0|-86.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference||
1653757|NCT01649856|3043046|Superiority or Other||Difference in Response Rates|8.2||||0.076||95.0|-1.1|17.5|||Chi-squared||||
1653758|NCT01649765|3043070|Superiority||Odds Ratio (OR)|2.92|||||2-Sided|95.0|1.19|7.17|||||Definition 2||
1653759|NCT01649765|3043070|Superiority||Odds Ratio (OR)|2.74|||||2-Sided|95.0|1.15|6.54|||||Definition 1||
1653682|NCT01652703|3042785|Superiority or Other||LS Mean Treatment Difference|-58.16|Standard Error of the Mean|3.21|<|0.001|2-Sided|95.0|-64.51|-51.81||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1653683|NCT01652703|3042785|Superiority or Other||LS Mean Treatment Difference|-63.94|Standard Error of the Mean|3.18|<|0.001|2-Sided|95.0|-70.23|-57.66||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1653684|NCT01652703|3042785|Superiority or Other||LS Mean Treatment Difference|-52.85|Standard Error of the Mean|3.03|<|0.001|2-Sided|95.0|-58.84|-46.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1653685|NCT01652703|3042785|Superiority or Other||LS Mean Treatment Difference|-68.61|Standard Error of the Mean|2.99|<|0.001|2-Sided|95.0|-74.51|-62.71||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factor of screening LDL-C level.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1653686|NCT01651949|3042846|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|2-Sided|95.0|-0.2|0.9|||Miettinen & Nurminen|||Anti-HPV Type 58|
1653687|NCT01651949|3042846|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|2-Sided|95.0|-0.2|0.9|||Miettinen & Nurminen|||Anti-HPV Type 52|
1653688|NCT01651949|3042846|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.2|||<|0.001|2-Sided|95.0|-0.4|1.0|||Miettinen & Nurminen|||Anti-HPV Type 45|
1653689|NCT01651949|3042846|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|2-Sided|95.0|-0.3|0.7|||Miettinen & Nurminen|||Anti-HPV Type 33|
1653690|NCT01651949|3042846|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.0|||<|0.001|2-Sided|95.0|-0.4|0.5|||Miettinen & Nurminen|||Anti-HPV Type 31|
1653691|NCT01651949|3042846|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|2-Sided|95.0|-0.4|0.8|||Miettinen & Nurminen|||Anti-HPV Type 18|
1653692|NCT01651949|3042846|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|2-Sided|95.0|-0.3|0.7|||Miettinen & Nurminen|||Anti-HPV Type 16|
1653693|NCT01651949|3042846|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|2-Sided|95.0|-0.3|0.8|||Miettinen & Nurminen|||Anti-HPV Type 11|
1653694|NCT01651949|3042846|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to seroconversion percentage (heterosexual males minus females) required that the lower bound of the 95% confidence interval was greater than -5|Risk Difference (RD)|0.1|||<|0.001|2-Sided|95.0|-0.7|0.9|||Miettinen & Nurminen|||Anti-HPV Type 6|
1653695|NCT01651949|3042847|Superiority or Other||Risk Difference (RD)|-1.5||||0.091|2-Sided|95.0|-3.4|0.2|||Miettinen & Nurminen||The incidence of maximum body temperature >=37.8° C reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Elevated Body Temperature|
1653696|NCT01651949|3042848|Superiority or Other||Risk Difference (RD)|-17.3|||<|0.001|2-Sided|95.0|-20.8|-13.7|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Swelling|
1653697|NCT01651949|3042848|Superiority or Other||Risk Difference (RD)|-19.1|||<|0.001|2-Sided|95.0|-22.5|-15.7|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Pain|
1653698|NCT01651949|3042848|Superiority or Other||Risk Difference (RD)|-11.5|||<|0.001|2-Sided|95.0|-15.0|-8.0|||Miettinen & Nurminen||The incidence of AEs of injection-site erythema reported on the Vaccination Report Card was compared between heterosexual / MSM male participants and female participants|Injection-site Erythema|
1653699|NCT01651949|3042849|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was >0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.25|||<|0.001|2-Sided|95.0|1.14|1.36|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 58|
1653760|NCT01649765|3043071|Superiority||Odds Ratio (OR)|1.49|||||2-Sided|95.0|0.64|3.46|||||||
1653700|NCT01651949|3042849|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was >0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.15|||<|0.001|2-Sided|95.0|1.05|1.26|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 52|
1653701|NCT01651949|3042849|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was >0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.27|||<|0.001|2-Sided|95.0|1.14|1.41|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 45|
1653702|NCT01651949|3042849|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was >0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.19|||<|0.001|2-Sided|95.0|1.1|1.3|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 33|
1653703|NCT01651949|3042849|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was >0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.24|||<|0.001|2-Sided|95.0|1.13|1.37|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 31|
1653704|NCT01651949|3042849|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was >0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.19|||<|0.001|2-Sided|95.0|1.08|1.31|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 18|
1653705|NCT01651949|3042849|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was >0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.2|||<|0.001|2-Sided|95.0|1.1|1.3|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 16|
1653706|NCT01651949|3042849|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was >0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.09|||<|0.001|2-Sided|95.0|1.0|1.19|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used||Anti-HPV Type 11|
1653707|NCT01651949|3042849|Non-Inferiority or Equivalence|Criterion for non-inferiority with respect to GMT ratio (heterosexual males / females) required that the lower bound of the 95% confidence interval was >0.67, to exclude a decrease of 1.5-fold or more|GMT Ratio|1.11|||<|0.001|2-Sided|95.0|1.02|1.21|||ANOVA|An analysis of variance model with a response of log individual titers and fixed effect for group was used.||Anti-HPV Type 6|
1653708|NCT01651936|3042852|Superiority or Other||Difference in least squares means|-0.41||||0.038|2-Sided|95.0|-0.79|-0.02|||Constrained Longitudinal Data Analysis||||
1653709|NCT01651936|3042854|Superiority or Other||Difference in percentages|8.46||||0.468|2-Sided|95.0|-10.4|27.32|||Cochran-Mantel-Haenszel||||
1653710|NCT01651936|3042856|Superiority or Other||Difference in percentages|-0.26||||0.91|2-Sided|95.0|-23.52|23.01|||Cochran-Mantel-Haenszel||||
1653711|NCT01651936|3042857|Superiority or Other||Difference in least squares means|-0.52||||0.308|2-Sided|95.0|-1.54|0.5|||Constrained Longitudinal Data Analysis||||
1653712|NCT01651793|3042862|Superiority|||||||0.05||||||P value reference to the beverage x time interaction effect|ANCOVA|||Hypotheses were tested using a series (all outcome variables) of 2 Treatment x 4 Time point, repeated measures ANCOVAs that controlled for the prior night’s sleep. Primary interests were the presence of statistically significant interactions of time and either cocoa versus placebo, cocoa + caffeine versus cocoa, or cocoa + caffeine versus caffeine-only. Significant interactions were decomposed using one-way ANOVAs and t-tests with familywise error controlled using LSD post-hoc tests.|
1653713|NCT01651780|3042873|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Relative Risk|0.89||||0.4967|2-Sided|95.0|0.64|1.24|||Chi-squared||||
1653714|NCT01651780|3042874|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Relative Risk|0.77||||0.2692|2-Sided|95.0|0.48|1.23|||Chi-squared||||
1653715|NCT01651403|3042876|Superiority|||||||0.007|||||||ANOVA|two-sided superiority test|||
1653716|NCT01651403|3042877|Superiority|Comparison of the difference in percentages|Exact Chan-Zhang method|11.4|||||2-Sided|95.0|-6.9|25.1|||||||
1653717|NCT01651403|3042882|Superiority||||||>|0.999|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata|||
1653718|NCT01651403|3042883|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|two-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata|||
1653719|NCT01651403|3042884|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata|||
1653720|NCT01651403|3042885|Superiority|||||||0.002|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata|||
1653721|NCT01651403|3042886|Superiority|||||||0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel tests adjusted for age at baseline and region strata|||
1653722|NCT01651403|3042887|Superiority|||||||0.935|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata|||
1653723|NCT01651403|3042888|Superiority||||||<|0.001|||||||Fisher Exact|Fisher's exact test without adjusting for strata at baseline|||
1653724|NCT01651403|3042888|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|2-sided Cochran-Mantel-Haenszel test adjusted for age at baseline and region strata|||
1653725|NCT01651260|3042897|Superiority or Other||upper probability of failure|0.05|||||||||||||Minimum sample size of 60 subjects was required based on the ability of the device to perform at an observed level of non-failure equivalent to an expected upper probability of failure not to exceed 5%.||
1653727|NCT01651208|3042899|Superiority or Other||||||<|0.01|||||||Chi-squared|||We hypothesized that in the MINT group, at least 70% of subjects will reach an MPR of 0.80 while in the DVD group, the proportion will remain at or below 55%. Our sample size estimates showed that, using a conservative 2-sided test at the 5% Alpha level and a 90% power, we will be able to detect a significant 15% difference (70% - 55%) with a sample of 217 in each study group.|
1653728|NCT01651117|3042929|Equivalence|Mixed methods ANCOVA with patient random effects, to compare change in HbA1c from baseline to 6 months between treatment and control groups.|Mean Difference (Final Values)|-0.3268|Standard Error of the Mean|0.1739||0.0611|2-Sided|95.0|-0.669|0.0154||Subject random effect included because same model was used for analyses of 2 separate follow up periods (baseline to 6 month, and baseline to 12 month, reported separately).|Mixed Models Analysis|Multiple imputation used for intent-to-treat analysis.|Negative parameter estimate means decrease in HbA1c was greater for treatment group than for control group.||
1653729|NCT01651000|3042964|Superiority or Other (legacy)||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1653730|NCT01651000|3042965|Superiority or Other (legacy)||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1653731|NCT01651000|3042966|Superiority or Other (legacy)||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1653732|NCT01650844|3042967|Other|We estimated the power to detect the smallest clinically significant difference in mean SFDs post intervention between the groups, accounting for repeated measures. A sample of 400 obtains greater than 90% power to detect a difference of 0.8 SFD per 2 weeks or greater. Analyses were multivariable modified intention to treat, including all participants with post intervention data. Generalized estimating equation (GEE) models were fitted with repeated asthma outcomes.|Mean Difference (Net)|0.8|Standard Deviation|2.8|<|0.05|2-Sided|||||Analyses were multivariable modified intention to treat, including all participants with post intervention data. Generalized estimating equation (GEE) models were fitted with repeated asthma outcomes.|Regression, Linear||||
1653733|NCT01650805|3042973|Superiority or Other|||||||0.317|||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score|||
1653734|NCT01650805|3042974|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score|||
1653735|NCT01650805|3042976|Superiority or Other|||||||0.074|||||||Cochran-Mantel-Haenszel|Stratified Analysis by Sokal score|||
1653736|NCT01650779|3042978|Superiority or Other|||||||0.3877|||||||One sample test of median (sign test)|||Baseline versus Month 6: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.|
1653737|NCT01650779|3042978|Superiority or Other|||||||0.7744|||||||One sample test of median (sign test)|||Baseline versus Month 4: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.|
1653738|NCT01650779|3042978|Superiority or Other|||||||0.5811|||||||One sample test of median (sign test)|||Baseline versus Month 2: Analysis was performed using one sample test of median (sign test). The percent change and absolute change from baseline in urine GL-3 levels were not normally distributed and thus medians were evaluated.|
1653739|NCT01650779|3042979|Superiority or Other|||||||0.0322|||||||One sample t-test|||Baseline versus Month 6: Analysis was performed using one sample t-test.|
1653740|NCT01650779|3042979|Superiority or Other|||||||0.1176|||||||One sample t-test|||Baseline versus Month 4: Analysis was performed using one sample t-test.|
1653741|NCT01650779|3042979|Superiority or Other|||||||0.1178|||||||One sample t-test|||Baseline versus Month 2: Analysis was performed using one sample t-test.|
1653742|NCT01650779|3042980|Superiority or Other||||||<|0.0001|||||||One sample t-test|||Baseline versus Month 6: Analysis was performed using one sample t-test.|
1653743|NCT01650779|3042980|Superiority or Other||||||<|0.0001|||||||One sample t-test|||Baseline versus Month 4: Analysis was performed using one sample t-test.|
1653744|NCT01650779|3042980|Superiority or Other||||||<|0.0002|||||||One sample t-test|||Baseline versus Month 2: Analysis was performed using one sample t-test.|
1653745|NCT01650545|3042990|Superiority|||||||0.03|||||||Log Rank||||
1653746|NCT01650194|3043018|Other||||||<|0.0001|||||||t-test, 2 sided|||Pregnenolone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.|
1653747|NCT01650194|3043019|Other|||||||0.0002|||||||t-test, 2 sided|||Progesterone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.|
1653748|NCT01650194|3043020|Other||||||<|0.0001|||||||t-test, 2 sided|||Androstenedione blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.|
1653749|NCT01650194|3043021|Other||||||<|0.0001|||||||t-test, 2 sided|||Cortisol blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.|
1653750|NCT01650194|3043023|Other||||||<|0.0001|||||||t-test, 2 sided|||Testosterone blood results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.|
1653751|NCT01650194|3043024|Other||||||<|0.0001|||||||t-test, 2 sided|||Pregnenolone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.|
1653752|NCT01650194|3043025|Other||||||<|0.0001|||||||t-test, 2 sided|||Progesterone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.|
1653753|NCT01650194|3043026|Other||||||<|0.0001|||||||t-test, 2 sided|||Androstenedione biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.|
1653754|NCT01650194|3043027|Other||||||<|0.0001|||||||t-test, 2 sided|||Cortisol biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.|
1653755|NCT01650194|3043029|Other|||||||0.615|||||||t-test, 2 sided|||Testosterone biomarker results collected at baseline and at Week 9 were compared using the paired t-test to evaluate the effect of enzalutamide.|
1653756|NCT01649947|3043032|Other||Mean Difference (Net)|56.0||||0.01|2-Sided|95.0|8.9|72.0|||t-test, 2 sided|||The analysis is comprised of evaluable patients who had measureable disease and received at least one cycle of therapy and had disease evaluated.|
1653767|NCT01649375|3043097|Superiority||Mean Difference (Net)|-1.96|Standard Error of the Mean|0.748||0.0096|2-Sided|95.0|-3.43|-0.48|||Mixed Models Analysis||||
1653768|NCT01649375|3043098|Superiority||Mean Difference (Net)|4.14|Standard Error of the Mean|1.105||0.0002|2-Sided|95.0|1.96|6.32|||Mixed Models Analysis||||
1653769|NCT01649375|3043098|Superiority||Mean Difference (Net)|2.84|Standard Error of the Mean|1.108||0.011|2-Sided|95.0|0.66|5.03|||Mixed Models Analysis||||
1653770|NCT01649375|3043099|Superiority||Mean Difference (Net)|-1.34|Standard Error of the Mean|0.353||0.0002|2-Sided|95.0|-2.04|-0.65|||Mixed Models Analysis||||
1653771|NCT01649375|3043099|Superiority||Mean Difference (Net)|-1.07|Standard Error of the Mean|0.353|<|0.0001|2-Sided|95.0|-1.77|-0.37|||Mixed Models Analysis||||
1653772|NCT01649375|3043100|Superiority||Odds Ratio (OR)|9.15|||<|0.0001|2-Sided|95.0|3.47|24.12|||Regression, Logistic|Missing ASAS responses considered nonresponders|||
1653773|NCT01649375|3043100|Superiority||Odds Ratio (OR)|6.13|||<|0.0003|2-Sided|95.0|2.31|16.26|||Regression, Logistic|Missing ASAS responses considered nonresponders|||
1653774|NCT01649375|3043101|Superiority||Mean Difference (Net)|0.49|||<|0.0001|2-Sided|95.0|0.37|0.64|||Mixed Models Analysis||||
1653775|NCT01649375|3043101|Superiority||Mean Difference (Net)|0.54|||<|0.0001|2-Sided|95.0|0.41|0.71|||Mixed Models Analysis||||
1653776|NCT01649375|3043102|Superiority||Odds Ratio (OR)|5.07|||<|0.0004|2-Sided|95.0|2.06|12.44|||Regression, Logistic|Missing ASAS responses considered nonresponders|||
1653777|NCT01649375|3043102|Superiority||Odds Ratio (OR)|2.99|||<|0.0194|2-Sided|95.0|1.19|7.48|||Regression, Logistic|Missing ASAS responses considered nonresponders|||
1653778|NCT01649375|3043103|Superiority||Odds Ratio (OR)|4.38|||<|0.0001|2-Sided|95.0|2.14|8.96|||Regression, Logistic|Missing ASAS responses considered nonresponders|||
1653779|NCT01649375|3043103|Superiority||Odds Ratio (OR)|1.82|||<|0.0967|2-Sided|95.0|0.9|3.67|||Regression, Logistic|Missing ASAS responses considered nonresponders|||
1653780|NCT01649362|3043104|Superiority or Other|||||||0.02|||||||Chi-squared||||
1653781|NCT01649362|3043105|Superiority or Other|||||||0.36|||||||t-test, 2 sided||||
1653782|NCT01649362|3043106|Superiority or Other|||||||0.63|||||||t-test, 2 sided||||
1653783|NCT01649297|3043107|Superiority or Other||Adjusted mean difference|-17.5|Standard Error of the Mean|3.4|<|0.0001||95.0|-24.1|-10.8|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)[MDRD]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)|
1653784|NCT01649297|3043107|Superiority or Other||Adjusted mean difference|-21.1|Standard Error of the Mean|3.4|<|0.0001||95.0|-27.7|-14.4|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)[MDRD]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)|
1653785|NCT01649297|3043107|Superiority or Other||Adjusted mean difference|-22.5|Standard Error of the Mean|3.4|<|0.0001||95.0|-29.2|-15.9|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)[MDRD]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)|
1653786|NCT01649297|3043107|Superiority or Other||Adjusted mean difference|-27.5|Standard Error of the Mean|3.4|<|0.0001||95.0|-34.2|-20.9|||ANCOVA|ANCOVA:'Treatment','geographical region','renal function'(screening(eGFR)[MDRD]value)-fixed effects and 'baseline HbA1c',baseline FPG-linear covariate||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing FPG after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided)|
1653787|NCT01649297|3043107|Superiority or Other||Adjusted mean difference|-5.0|Standard Error of the Mean|2.8|<|||95.0|-10.4|0.5|||||||
1653788|NCT01649297|3043107|Superiority or Other||Adjusted mean difference|-3.6|Standard Error of the Mean|2.8|<|||95.0|-9.0|1.8|||||||
1653789|NCT01649297|3043108|Superiority or Other||Adjusted mean difference|-0.42|Standard Error of the Mean|0.09|<|0.0001||95.0|-0.6|-0.25|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR [MDRD] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).|
1653790|NCT01649297|3043108|Superiority or Other||Adjusted mean difference|-0.44|Standard Error of the Mean|0.09|<|0.0001||95.0|-0.62|-0.27|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR [MDRD] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).|
1653791|NCT01649297|3043108|Superiority or Other||Adjusted mean difference|-0.5|Standard Error of the Mean|0.09|<|0.0001||95.0|-0.68|-0.32|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR [MDRD] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).|
1653818|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.99|||<|0.001|2-Sided|95.0|-1.39|-0.6|||Mixed Models Analysis|||Bedtime, Week 52|
1653792|NCT01649297|3043108|Superiority or Other||Adjusted mean difference|-0.61|Standard Error of the Mean|0.09|<|0.0001||95.0|-0.79|-0.44|||ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR [MDRD] value)- fixed effects and baseline HbA1c- linear covariate.||Superiority of once daily dose of empagliflozin (10 mg and 25 mg) versus placebo and superiority of twice daily dose of empagliflozin (5 mg and 12.5 mg) versus placebo in reducing HbA1c after 16 weeks of treatment was tested in an exploratory manner, to demonstrate assay sensitivity against placebo at 0.05 level (two-sided).|
1653793|NCT01649297|3043108|Non-Inferiority or Equivalence|"Null hypotheses for non-inferiority:~H10: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 10 mg once daily + 0.35%~H20: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 12.5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 25 mg once daily + 0. 35%"|Adjusted mean difference|-0.11|Standard Error of the Mean|0.07|<|0.0001||95.0|-0.26|0.03||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR [MDRD] value)- fixed effects and baseline HbA1c- linear covariate.||The primary objective was to test the non-inferiority of empagliflozin 5 mg BID versus empagliflozin 10 mg QD, and non-inferiority of empagliflozin 12.5 mg BID versus empagliflozin 25 mg QD, assuming a non-inferiority margin of 0.35%|
1653794|NCT01649297|3043108|Non-Inferiority or Equivalence|"Null hypotheses for non-inferiority:~H10: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 10 mg once daily + 0.35%~H20: Mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 12.5 mg twice daily ≥ mean change from baseline in HbA1c (%) after 16 weeks of treatment with empagliflozin 25 mg once daily + 0. 35%"|Adjusted mean difference|-0.02|Standard Error of the Mean|0.07|<|0.0001||95.0|-0.16|0.13||The two non-inferiority hypotheses H10 and H20 were tested using the Hochberg procedure in order to control the family-wise type I error at 0.025 (one-sided).|ANCOVA|ANCOVA: Treatment, geographical region, renal function (screening eGFR [MDRD] value)- fixed effects and baseline HbA1c- linear covariate.||The primary objective was to test the non-inferiority of empagliflozin 5 mg BID versus empagliflozin 10 mg QD, and non-inferiority of empagliflozin 12.5 mg BID versus empagliflozin 25 mg QD, assuming a non-inferiority margin of 0.35%|
1653795|NCT01648790|3043145|Superiority or Other||Ratio of Geometric Least Squares Means|0.779|||||2-Sided|90.0|0.724|0.837|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.||
1653796|NCT01648790|3043146|Superiority or Other||Ratio of Geometric Least Squares Means|0.28|||||2-Sided|90.0|0.233|0.335|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.||
1653797|NCT01648790|3043147|Superiority or Other||Ratio of Geometric Least Squares Means|0.987|||||2-Sided|90.0|0.918|1.06|||||LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.||
1653798|NCT01648790|3043148|Superiority or Other||Ratio of Geometric Least Squares Means|0.983|||||2-Sided|90.0|0.819|1.18|||||Least Squares (LS) means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.||
1653799|NCT01648582|3043167|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis|||Week 52|
1653800|NCT01648582|3043167|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis|||Week 26|
1653801|NCT01648582|3043168|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis|||Week 52|
1653802|NCT01648582|3043168|Superiority or Other (legacy)||||||<|0.001||||||Week 26|Mixed Models Analysis||||
1653803|NCT01648582|3043175|Superiority or Other (legacy)||||||<|0.001||||||Overall p-value|Mixed Models Analysis|||Week 52|
1653804|NCT01648582|3043175|Superiority or Other (legacy)||||||<|0.001||||||Overall p-value|Mixed Models Analysis|||Week 26|
1653805|NCT01648582|3043176|Superiority or Other (legacy)|||||||0.11||||||Overall p-value|Mixed Models Analysis|||Week 52 DBP|
1653806|NCT01648582|3043176|Superiority or Other (legacy)|||||||0.169||||||Overall p-value|Mixed Models Analysis|||Week 52 SBP|
1653807|NCT01648582|3043176|Superiority or Other (legacy)|||||||0.584||||||Overall p-value|Mixed Models Analysis|||Week 26 DBP|
1653808|NCT01648582|3043176|Superiority or Other (legacy)|||||||0.008||||||Overall p-value|Mixed Models Analysis|||Week 26 SBP|
1653809|NCT01648582|3043179|Superiority or Other (legacy)||Mean Difference (Net)|35.19|Standard Error of the Mean|2.864||0.029|2-Sided||||||Mixed Models Analysis|||HOMA2-%S, Dula 0.75 mg, Week 52|
1653810|NCT01648582|3043179|Superiority or Other (legacy)||Mean Difference (Net)|41.02|Standard Error of the Mean|2.9||0.029|2-Sided||||||Mixed Models Analysis|||HOMA2-%S, Dula 1.5 mg, Week 52|
1653811|NCT01648582|3043179|Superiority or Other (legacy)||Mean Difference (Net)|30.42|Standard Error of the Mean|2.94||0.025|2-Sided||||||Mixed Models Analysis|||HOMA2-%S, Dula 0.75 mg, Week 26|
1653812|NCT01648582|3043179|Superiority or Other (legacy)||Mean Difference (Net)|36.57|Standard Error of the Mean|2.977||0.025|2-Sided||||||Mixed Models Analysis|||HOMA2-%S, Dula 1.5 mg, Week 26|
1653813|NCT01648582|3043180|Superiority or Other (legacy)||Mean Difference (Net)|36.64|Standard Error of the Mean|4.061||0.025|2-Sided||||||Mixed Models Analysis|||HOMA2-%B, Dula 0.75 mg, Week 52|
1653814|NCT01648582|3043180|Superiority or Other (legacy)||Mean Difference (Net)|45.12|Standard Error of the Mean|4.147||0.025|2-Sided||||||Mixed Models Analysis|||HOMA2-%B, Dula 1.5, Week 52|
1653815|NCT01648582|3043180|Superiority or Other (legacy)||Mean Difference (Net)|31.17|Standard Error of the Mean|3.761||0.352|2-Sided||||||Mixed Models Analysis|||HOMA2-%B, Dula 0.75 mg, Week 26|
1653816|NCT01648582|3043180|Superiority or Other (legacy)||Mean Difference (Net)|34.41|Standard Error of the Mean|3.831||0.352|2-Sided||||||Mixed Models Analysis|||HOMA2-%B, Dula 1.5 mg, Week 26|
1653817|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.59||||0.003|2-Sided|95.0|-0.98|-0.2|||Mixed Models Analysis|||Bedtime, Week 52|
1653981|NCT01646177|3043408|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653819|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.45|||<|0.039|2-Sided|95.0|-0.87|-0.02|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 52|
1653820|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.83|||<|0.001|2-Sided|95.0|-1.26|-0.41|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 52|
1653821|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.1|||<|0.603|2-Sided|95.0|-0.47|0.27|||Mixed Models Analysis|||Evening pre-meal, Week 52|
1653822|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.64|||<|0.001|2-Sided|95.0|-1.01|-0.27|||Mixed Models Analysis|||Evening pre-meal, Week 52|
1653823|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.48|||<|0.029|2-Sided|95.0|-0.92|-0.05|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 52|
1653824|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.63|||<|0.004|2-Sided|95.0|-1.07|-0.2|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 52|
1653825|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.05|||<|0.783|2-Sided|95.0|-0.32|0.42|||Mixed Models Analysis|||Mid-day pre-meal, Week 52|
1653826|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.43|||<|0.024|2-Sided|95.0|-0.8|-0.06|||Mixed Models Analysis|||Mid-day pre-meal, Week 52|
1653827|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.21|||<|0.384|2-Sided|95.0|-0.67|0.26|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 52|
1653828|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.53|||<|0.025|2-Sided|95.0|-1.0|-0.07|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 52|
1653829|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|1.06|||<|0.001|2-Sided|95.0|0.82|1.31|||Mixed Models Analysis|||Morning pre-meal, Week 52|
1653830|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|0.77|||<|0.001|2-Sided|95.0|0.52|1.01|||Mixed Models Analysis|||Morning pre-meal, Week 52|
1653831|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.35|||<|0.067|2-Sided|95.0|-0.73|-0.03|||Mixed Models Analysis|||Bedtime, Week 26|
1653832|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.79|||<|0.001|2-Sided|95.0|-1.17|-0.41|||Mixed Models Analysis|||Bedtime, Week 26|
1653833|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.47|||<|0.024|2-Sided|95.0|-0.88|-0.06|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 26|
1653834|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.89|||<|0.001|2-Sided|95.0|-1.3|-0.48|||Mixed Models Analysis|||Evening 2-hours post-meal, Week 26|
1653835|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.12|||<|0.489|2-Sided|95.0|-0.45|0.22|||Mixed Models Analysis|||Evening pre-meal, Week 26|
1653836|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.63|||<|0.001|2-Sided|95.0|-0.97|-0.29|||Mixed Models Analysis|||Evening pre-meal, Week 26|
1653837|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.6|||<|0.004|2-Sided|95.0|-1.01|-0.19|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 26|
1653838|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-1.05|||<|0.001|2-Sided|95.0|-1.46|-0.64|||Mixed Models Analysis|||Mid-day 2-hours post-meal, Week 26|
1653839|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|0.03|||<|0.855|2-Sided|95.0|-0.32|0.39|||Mixed Models Analysis|||Mid-day pre-meal, Week 26|
1653840|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.35|||<|0.055|2-Sided|95.0|-0.7|0.01|||Mixed Models Analysis|||Mid-day pre-meal, Week 26|
1653841|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.11|||<|0.617|2-Sided|95.0|-0.53|0.32|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 26|
1653842|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|-0.49|||<|0.024|2-Sided|95.0|-0.92|-0.07|||Mixed Models Analysis|||Morning 2-hours post-meal, Week 26|
1653843|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|0.94|||<|0.001|2-Sided|95.0|0.71|1.17|||Mixed Models Analysis|||Morning pre-meal, Week 26|
1653844|NCT01648582|3043181|Superiority or Other (legacy)||Mean Difference (Net)|0.65|||<|0.001|2-Sided|95.0|0.42|0.88|||Mixed Models Analysis|||Morning pre-meal, Week 26|
1653845|NCT01648582|3043182|Superiority or Other (legacy)||Mean Difference (Net)|0.82|||<|0.001|2-Sided|95.0|0.45|1.2|||Mixed Models Analysis|||Week 52|
1653846|NCT01648582|3043182|Superiority or Other (legacy)||Mean Difference (Net)|0.12|||<|0.518|2-Sided|95.0|-0.25|0.5|||Mixed Models Analysis|||Week 52|
1653847|NCT01648582|3043182|Superiority or Other (legacy)||Mean Difference (Net)|0.88|||<|0.001|2-Sided|95.0|0.53|1.23|||Mixed Models Analysis|||Week 26|
1653848|NCT01648582|3043182|Superiority or Other (legacy)||Mean Difference (Net)|0.24|||<|0.177|2-Sided|95.0|-0.11|0.59|||Mixed Models Analysis|||Week 26|
1653849|NCT01648582|3043183|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact|||<=6.5% Week 52|
1653850|NCT01648582|3043183|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact|||<=6.5% Week 52|
1653851|NCT01648582|3043183|Superiority or Other (legacy)||||||<|0.002|||||||Fisher Exact|||<7.0% Week 52|
1653852|NCT01648582|3043183|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact|||<7.0% Week 52|
1653853|NCT01648582|3043183|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact|||<=6.5% Week 26|
1653854|NCT01648582|3043183|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact|||<=6.5% Week 26|
1653855|NCT01648582|3043183|Superiority or Other (legacy)||||||<|0.004|||||||Fisher Exact|||<7.0 Week 26|
1653856|NCT01648582|3043183|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact|||<7.0% Week 26|
1653857|NCT01648582|3043184|Non-Inferiority or Equivalence (legacy)|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.13|||||2-Sided|95.0|-0.33|-0.06|||||||
1653858|NCT01648582|3043184|Non-Inferiority or Equivalence (legacy)|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.57|||||2-Sided|95.0|-0.77|-0.38|||||||
1653982|NCT01646177|3043409|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653859|NCT01648582|3043185|Non-Inferiority or Equivalence (legacy)|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.18|||||2-Sided|95.0|-0.35|-0.01|||||||
1653860|NCT01648582|3043185|Non-Inferiority or Equivalence (legacy)|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.57|||||2-Sided|95.0|-0.74|-0.4|||||||
1653861|NCT01648348|3043209|Superiority|||||||0.83|||||||proportion test||||
1653862|NCT01648348|3043210|Superiority|||||||0.65|||||||t-test, 2 sided|||Bladder control symptom scale/item t-test, 2-sided, unpooled.|
1653863|NCT01648348|3043210|Superiority|||||||0.1|||||||t-test, 2 sided|||Weakness of legs symptom scale/item t-test, 2-sided, unpooled.|
1653864|NCT01648348|3043210|Superiority|||||||0.77|||||||t-test, 2 sided|||Hair loss symptom scale/item t-test, 2-sided, unpooled.|
1653865|NCT01648348|3043210|Superiority|||||||0.15|||||||t-test, 2 sided|||Itchy skin symptom scale/item t-test, 2-sided, unpooled.|
1653866|NCT01648348|3043210|Superiority|||||||0.82|||||||t-test, 2 sided|||Drowsiness symptom scale/item t-test, 2-sided, unpooled.|
1653867|NCT01648348|3043210|Superiority|||||||0.9|||||||t-test, 2 sided|||Seizures symptom scale/item t-test, 2-sided, unpooled.|
1653868|NCT01648348|3043210|Superiority|||||||0.17|||||||t-test, 2 sided|||Headaches symptom scale/item t-test, 2-sided, unpooled.|
1653869|NCT01648348|3043210|Superiority|||||||0.75|||||||t-test, 2 sided|||Communication deficit symptom scale/item t-test, 2-sided, unpooled.|
1653870|NCT01648348|3043210|Superiority|||||||0.99|||||||t-test, 2 sided|||Motor dysfunction symptom scale/item t-test, 2-sided, unpooled.|
1653871|NCT01648348|3043210|Superiority|||||||0.16|||||||t-test, 2 sided|||Visual disorder symptom scale/item t-test, 2-sided, unpooled.|
1653872|NCT01648348|3043210|Superiority|||||||0.55|||||||t-test, 2 sided|||Future uncertainty symptom scale/item t-test, 2-sided, unpooled.|
1653873|NCT01648348|3043211|Superiority|||||||0.19|||||||t-test, 2 sided||||
1653874|NCT01648348|3043213|Superiority||Hazard Ratio (HR)|1.06||||0.82|2-Sided|95.0|0.66|1.69|||Log Rank||||
1653875|NCT01648348|3043214|Superiority||||||<|0.001|||||||Fisher Exact||||
1653876|NCT01648348|3043215|Superiority||Hazard Ratio (HR)|1.14||||0.57|2-Sided|95.0|0.73|1.77|||Log Rank||||
1653877|NCT01648283|3043226|Superiority||||||<|0.05|||||||ANOVA||||
1653878|NCT01647542|3043298|Superiority or Other||Least Squares Mean Difference|-24.9|Standard Error of the Mean|30.4||0.427|2-Sided|95.0|-90.1|40.3||No multiplicity adjustments.|ANCOVA|Treatment and country as fixed factors and baseline value as covariate.|||
1653879|NCT01647542|3043298|Superiority or Other||Least Squares Mean Difference|5.9|Standard Error of the Mean|29.72||0.846|2-Sided|95.0|-57.9|69.6||No multiplicity adjustments.|ANCOVA|Treatment and country as fixed factors and baseline value as covariate.|||
1653880|NCT01647542|3043299|Superiority or Other||Least Squares mean Difference|-35.7|Standard Error of the Mean|4.36|<|0.001|2-Sided|95.0|-44.3|-27.1||No multiplicity adjustment.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.|||
1653881|NCT01647542|3043299|Superiority or Other||Least squares mean difference|-35.6|Standard Error of the Mean|4.36|<|0.001|2-Sided|95.0|-44.2|-26.9||No multiplicity adjustment.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value covariate.|||
1653882|NCT01647542|3043300|Superiority or Other||Odds Ratio (OR)|3.42|||<|0.001|2-Sided|95.0|1.81|6.49||No multiplicity adjustment.|Regression, Logistic|Treatment and baseline HbA1c as explanatory variables.|||
1653883|NCT01647542|3043300|Superiority or Other||Odds Ratio (OR)|5.66|||<|0.001|2-Sided|95.0|2.99|10.72||No multiplicity adjustment.|Regression, Logistic|Treatment and baseline HbA1c as explanatory variables.|||
1653884|NCT01647542|3043301|Superiority or Other||Least squares mean difference|-0.82|Standard Error of the Mean|0.126|<|0.001|2-Sided|95.0|-1.07|-0.57||Stepwise Comparison: 1) TAK-875 50 mg versus (vs.) placebo, 2) TAK-875 25 mg vs. placebo. Step 2 was performed only if p-value at step 1 was <=0.050.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||Assuming a standard deviation of 0.9% in change from baseline in HbA1c to Week 24 and a dropout rate of 15%, 210 participants per group provided at least 95% power to detect a treatment difference of 0.5% between treatment arms at a 2–sided significance level of 0.05.|
1653885|NCT01647542|3043301|Superiority or Other||Least squares mean difference|-1.03|Standard Error of the Mean|0.126|<|0.001|2-Sided|95.0|-1.27|-0.78||Stepwise Comparison: 1) TAK-875 50 mg versus (vs.) placebo, 2) TAK-875 25 mg vs. placebo. Step 2 was performed only if p-value at step 1 was <=0.050.|Mixed Model Repeated Measures|Treatment, country, visit, and visit-by-treatment interaction as fixed factors, baseline value as covariate.||Assuming a standard deviation of 0.9% in change from baseline in HbA1c to Week 24 and a dropout rate of 15%, 210 participants per group provided at least 95% power to detect a treatment difference of 0.5% between treatment arms at a 2–sided significance level of 0.05.|
1653886|NCT01646398|3043337|Superiority or Other||GMT Ratio|3.1|||||2-Sided|95.0|2.38|4.14||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 2.0.|
1653887|NCT01646398|3043337|Superiority or Other||GMT Ratio|2.5|||||2-Sided|95.0|1.84|3.49||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.|
1653888|NCT01646398|3043337|Superiority or Other||GMT Ratio|2.0|||||2-Sided|95.0|1.42|2.79||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.|
1653889|NCT01646398|3043337|Superiority or Other||GMT Ratio|2.3|||||2-Sided|95.0|1.81|2.92||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.|
1653890|NCT01646398|3043337|Superiority or Other||GMT Ratio|2.1|||||2-Sided|95.0|1.61|2.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.|
1653891|NCT01646398|3043337|Superiority or Other||GMT Ratio|1.0|||||2-Sided|95.0|0.77|1.23||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.|
1653892|NCT01646398|3043337|Superiority or Other||GMT Ratio|2.3|||||2-Sided|95.0|1.59|3.24||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.|
1653893|NCT01646398|3043337|Superiority or Other||GMT Ratio|1.4|||||2-Sided|95.0|1.12|1.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.|
1653894|NCT01646398|3043337|Superiority or Other||GMT Ratio|1.4|||||2-Sided|95.0|1.1|1.75||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.|
1653895|NCT01646398|3043337|Superiority or Other||GMT Ratio|2.9|||||2-Sided|95.0|2.22|3.86||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.|
1653896|NCT01646398|3043337|Superiority or Other||GMT Ratio|2.6|||||2-Sided|95.0|1.96|3.44||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.|
1653897|NCT01646398|3043337|Superiority or Other||GMT Ratio|0.7|||||2-Sided|95.0|0.59|0.89||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.|
1653898|NCT01646398|3043337|Superiority or Other||GMT Ratio|1.3|||||2-Sided|95.0|0.99|1.75||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS). Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 1.0.|
1653899|NCT01646398|3043338|Superiority or Other||Difference in percentage|26.8|||||2-Sided|95.0|19.3|34.0||||||Difference in proportions (13vPnC – 23vPS) expressed as a percentage presented along with exact, 2-sided 95%CI. Statistical significance was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.|
1653900|NCT01646398|3043339|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||2-Sided|95.0|1.84|3.49||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1653901|NCT01646398|3043339|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.0|||||2-Sided|95.0|1.42|2.79||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1653902|NCT01646398|3043339|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||2-Sided|95.0|1.81|2.92||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1653903|NCT01646398|3043339|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.1|||||2-Sided|95.0|1.61|2.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1653904|NCT01646398|3043339|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||2-Sided|95.0|0.77|1.23||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1653905|NCT01646398|3043339|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||2-Sided|95.0|1.59|3.24||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1653906|NCT01646398|3043339|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||2-Sided|95.0|1.12|1.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1653907|NCT01646398|3043339|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||2-Sided|95.0|1.1|1.75||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1653983|NCT01646177|3043409|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653984|NCT01646177|3043409|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653908|NCT01646398|3043339|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||2-Sided|95.0|2.22|3.86||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1653909|NCT01646398|3043339|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.6|||||2-Sided|95.0|1.96|3.44||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1653910|NCT01646398|3043339|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||2-Sided|95.0|0.59|0.89||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1653911|NCT01646398|3043339|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||2-Sided|95.0|0.99|1.75||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1653912|NCT01646385|3043342|Superiority or Other||||||<|0.001|||||||ANCOVA|||Change at Year 3: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.|
1653913|NCT01646385|3043342|Superiority or Other||||||<|0.001|||||||ANCOVA|||Change at Year 2: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.|
1653914|NCT01646385|3043342|Superiority or Other||||||<|0.001|||||||ANCOVA|||Change at Year 1: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline HAQ, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.|
1653915|NCT01646385|3043343|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1653916|NCT01646385|3043346|Superiority or Other|||||||0.01|||||||ANCOVA|||Change at Year 5: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.|
1653917|NCT01646385|3043346|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Change at Year 4: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.|
1653918|NCT01646385|3043346|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Change at Year 3: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.|
1653919|NCT01646385|3043346|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Change at Year 2: analysis was performed with ANCOVA using the GLM method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.|
1653920|NCT01646385|3043346|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Change at Year 1: analysis was performed with Analysis of Covariance (ANCOVA) using the General Linear Model (GLM) method applying age, gender, baseline DAS28, previous non-RA drugs, baseline steroid, and baseline methotrexate as covariates.|
1653921|NCT01646385|3043347|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1653922|NCT01646385|3043350|Superiority or Other||Hazard Ratio (HR)|0.717||||0.024|2-Sided|95.0|0.537|0.958|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, methotrexate, baseline HAQ score, Charlson index, smoking history, and body mass index was used for analysis.|
1653923|NCT01646385|3043351|Superiority or Other||Hazard Ratio (HR)|0.7||||0.001|2-Sided|95.0|0.564|0.87|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, methotrexate, and baseline health assessment questionnaire (HAQ) score was used for analysis.|
1653924|NCT01646385|3043352|Superiority or Other||Hazard Ratio (HR)|1.019||||0.855|2-Sided|95.0|0.831|1.251|||Regression, Cox|||Cox proportional hazards model adjusted for age, gender, previous non-RA drugs, baseline steroid, baseline DMARDs, methotrexate, disease activity score based on 28-joints count (DAS28), and smoking history was used for analysis.|
1653925|NCT01646385|3043353|Superiority or Other||Hazard Ratio (HR)|0.512||||0.035|2-Sided|95.0|0.276|0.952|||Regression, Cox|||Cox proportional hazards model adjusted for age was used for analysis.|
1653926|NCT01646385|3043354|Superiority or Other||Hazard Ratio (HR)|0.836||||0.084|2-Sided|95.0|0.683|1.025|||Regression, Cox|||Cox proportional hazards model adjusted for age, baseline steroid, smoking history, previous cancer, and body mass index was used for analysis.|
1653927|NCT01646320|3043362|Superiority or Other||Mean Difference (Final Values)|25.5|||<|0.0001|2-Sided|95.0|16.7|34.4||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Modified logistic regression||||
1653928|NCT01646320|3043363|Superiority or Other||Mean Difference (Final Values)|-1.5|Standard Error of the Mean|0.3126|<|0.0001|2-Sided|95.0|-2.12|-0.89||Secondary endpoints are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis||||
1653929|NCT01646320|3043364|Superiority or Other||Mean Difference (Final Values)|-35.5|Standard Error of the Mean|5.493|<|0.0001|2-Sided|95.0|-46.3|-24.7||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis||||
1653930|NCT01646320|3043365|Superiority or Other||Mean Difference (Final Values)|-27.5|Standard Error of the Mean|4.015|<|0.0001|2-Sided|95.0|-35.4|-19.6||Secondary end points are tested following a sequential testing procedure at alpha=0.05|Longitudinal Repeated Measures Analysis||||
1653931|NCT01646320|3043366|Superiority or Other||Mean Difference (Final Values)|-0.72|Standard Error of the Mean|0.0964|<|0.0001|2-Sided|95.0|-0.91|-0.53||Tested at alpha=0.05|Longitudinal Repeated Measures Analysis||||
1653985|NCT01646177|3043410|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653986|NCT01646177|3043410|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653987|NCT01646177|3043410|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653988|NCT01646177|3043411|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653932|NCT01646268|3043370|Superiority or Other||LS Means|-4.82|Standard Error of the Mean|1.2|<|0.0001|2-Sided|95.0|-7.18|-2.45|||ANCOVA||Value describes the difference value of the mean change from baseline between Rotigotine and Placebo groups. The Value for this outcome was -4.6.|The null hypothesis (H0) is that there is no difference in the change in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+II) between the active treatment and the placebo groups (i.e., the change from Baseline in the sum of the score from the ADL and motor examination in the UPDRS (Parts II+III) is the same for both groups).|
1653933|NCT01646255|3043383|Superiority or Other||Least Square Mean|-1.2|||=|0|2-Sided|95.0|-1.83|-0.57||Primary efficacy analyses was made with confirmatory 2-sided test with significance level 0.05.|ANCOVA|||Estimate of treatment effect has been obtained from an analysis of covariance (ANCOVA) model to the change from Baseline value in absolute time spent “off”. The ANCOVA model contained treatment and (pooled) site as factors and Baseline “off” time as covariate. A last observation carried forward (LOCF) imputation approach was used for missing values (during both Titration and Maintenance Periods) for the primary efficacy analysis.|
1653934|NCT01646177|3043397|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653935|NCT01646177|3043397|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653936|NCT01646177|3043397|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653937|NCT01646177|3043398|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653938|NCT01646177|3043398|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653939|NCT01646177|3043398|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653940|NCT01646177|3043399|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653941|NCT01646177|3043399|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653942|NCT01646177|3043399|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653943|NCT01646177|3043400|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653944|NCT01646177|3043400|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653945|NCT01646177|3043400|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653946|NCT01646177|3043401|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from MCS.|
1653947|NCT01646177|3043401|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from MCS.|
1653948|NCT01646177|3043401|Superiority or Other (legacy)||||||<|0.031|||||||ANCOVA|||Includes analysis only from MCS.|
1653949|NCT01646177|3043401|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from PCS.|
1653950|NCT01646177|3043401|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from PCS.|
1653951|NCT01646177|3043401|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from PCS.|
1653952|NCT01646177|3043402|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.|
1653953|NCT01646177|3043402|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.|
1653954|NCT01646177|3043402|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from Work Productively Loss Score.|
1653955|NCT01646177|3043402|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from Presenteeism Score.|
1653956|NCT01646177|3043402|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from Presenteeism Score.|
1653957|NCT01646177|3043402|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from Presenteeism Score.|
1653958|NCT01646177|3043402|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from Activity Impairment Score.|
1653959|NCT01646177|3043402|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from Activity Impairment Score.|
1653960|NCT01646177|3043402|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|||Includes analysis only from Activity Impairment Score.|
1653961|NCT01646177|3043402|Superiority or Other (legacy)||||||<|0.012|||||||ANCOVA|||Includes analysis only from Absenteeism Score.|
1653962|NCT01646177|3043402|Superiority or Other (legacy)||||||<|0.045|||||||ANCOVA|||Includes analysis only from Absenteeism Score.|
1653963|NCT01646177|3043402|Superiority or Other (legacy)||||||<|0.006|||||||ANCOVA|||Includes analysis only from Absenteeism Score.|
1653964|NCT01646177|3043403|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA||||
1653965|NCT01646177|3043403|Superiority or Other (legacy)||||||<|0.015|||||||ANCOVA||||
1653966|NCT01646177|3043403|Superiority or Other (legacy)||||||<|0.473|||||||ANCOVA||||
1653967|NCT01646177|3043404|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653968|NCT01646177|3043404|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653969|NCT01646177|3043404|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653970|NCT01646177|3043405|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653971|NCT01646177|3043405|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653972|NCT01646177|3043405|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653973|NCT01646177|3043406|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653974|NCT01646177|3043406|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653975|NCT01646177|3043406|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653976|NCT01646177|3043407|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653977|NCT01646177|3043407|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653978|NCT01646177|3043407|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1653979|NCT01646177|3043408|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653980|NCT01646177|3043408|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653993|NCT01646177|3043412|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653994|NCT01646177|3043413|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653995|NCT01646177|3043413|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653996|NCT01646177|3043413|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1653997|NCT01646125|3043431|Superiority or Other||Cox Proportional Hazard|0.76|||||2-Sided|90.0|0.35|1.63|||||||
1653998|NCT01646021|3043463|Superiority||Hazard Ratio (HR)|0.74|||=|0|2-Sided|95.0|0.54|1.02|||Log Rank||||
1653999|NCT01646021|3043465|Other||Hazard Ratio (HR)|0.45|||<|0.0001|2-Sided|95.0|0.35|0.6|||Log Rank||||
1654000|NCT01645280|3043491|Superiority or Other|||||||0.345|||||||ANCOVA|Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.|||
1654001|NCT01645280|3043491|Superiority or Other|||||||0.28|||||||ANCOVA|Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.|||
1654002|NCT01645280|3043491|Superiority or Other|||||||0.134|||||||ANCOVA|Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.|||
1654003|NCT01645280|3043491|Superiority or Other|||||||0.06|||||||ANCOVA|Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.|||
1654004|NCT01645280|3043492|Superiority or Other|||||||0.273|||||||Cochran-Mantel-Haenszel|Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.|||
1654005|NCT01645280|3043492|Superiority or Other|||||||0.629|||||||Cochran-Mantel-Haenszel|Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.|||
1654006|NCT01645280|3043492|Superiority or Other|||||||0.543|||||||Cochran-Mantel-Haenszel|Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.|||
1654007|NCT01645280|3043492|Superiority or Other|||||||0.381|||||||Cochran-Mantel-Haenszel|Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.|||
1654008|NCT01645280|3043493|Superiority or Other|||||||0.045|||||||ANCOVA|Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.|||
1654009|NCT01645280|3043493|Superiority or Other|||||||0.248|||||||ANCOVA|Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.|||
1654010|NCT01645280|3043493|Superiority or Other|||||||0.025|||||||ANCOVA|Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.|||
1654011|NCT01645280|3043493|Superiority or Other|||||||0.019|||||||ANCOVA|Treatment, screening CRP level (>=1.50 mg/dL, <1.50mg/dL) and baseline score as covariates.|||
1654012|NCT01645280|3043494|Superiority or Other|||||||0.832|||||||Cochran-Mantel-Haenszel|Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.|||
1654013|NCT01645280|3043494|Superiority or Other|||||||0.642|||||||Cochran-Mantel-Haenszel|Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.|||
1654014|NCT01645280|3043494|Superiority or Other|||||||0.13|||||||Cochran-Mantel-Haenszel|Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.|||
1654015|NCT01645280|3043494|Superiority or Other|||||||0.184|||||||Cochran-Mantel-Haenszel|Screening CRP level (>= 1.50 mg/dL; < 1.50 mg/dL) was used as stratification factors.|||
1654016|NCT01644890|3043511|Other||Difference in ORR (%)|-7.5|||||2-Sided|95.0|-17.4|2.7|||||||
1654017|NCT01644890|3043512|Other||Hazard Ratio (HR)|1.197|||||2-Sided|95.0|0.885|1.62|||||History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status [(+) or (-)], and Disease free interval (<12 months or ≥12 months) were covariates for adjustment.||
1654018|NCT01644890|3043513|Non-Inferiority|The primary PFS analysis was confirmed whether or not the upper limit of the 95% confidence interval (CI) for the hazard ratio (HR) for NK105 relative to PTX fell below the non-inferiority margin of 1.215 (<1.215) by fitting a Cox proportional hazards model that included allocation adjustment factors other than the study site as covariates.|Hazard Ratio (HR)|1.255|||||2-Sided|95.0|0.989|1.592|||||History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status [(+) or (-)], and Disease free interval (<12 months or ≥12 months) were covariates for adjustment.|Based on the results of previous studies, the expected median PFS was 5.5 months for PTX and 6.35 months for NK105. Assuming a randomization period of 18 months, a follow-up period of 12 months, a one-sided significance level of 2.5%, a power of 85% and the non-inferiority margin of 1.215, the number of patients was estimated to 172 pts per group, a total of 344 patients. Considering an expected withdrawal/dropout rate of approximately 20%, the target sample size was set at 414.|
1654019|NCT01644734|3043514|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Null hypothesis: no change in the total CAT score between baseline and after 3 months.|
1654020|NCT01644617|3043556|Superiority or Other||Difference in Percentage Versus Placebo|-14.6|||||2-Sided|95.0|-28.5|-5.4|||||Analysis based on the Miettinen and Nurminen method||
1654021|NCT01644617|3043556|Superiority or Other||Difference in Percentage Versus Placebo|-7.5|||||2-Sided|95.0|-22.6|6.7|||||Analysis based on the Miettinen and Nurminen method||
1654022|NCT01644617|3043557|Superiority or Other||Difference in Percentage Versus Placebo|9.8|||||2-Sided|95.0|-7.0|26.6|||||Analysis based on the Miettinen and Nurminen method||
1654023|NCT01644617|3043557|Superiority or Other||Difference in Percentage Versus Placebo|12.4||||||95.0|-3.6|28.9|||||Analysis based on the Miettinen and Nurminen method||
1654024|NCT01644617|3043558|Superiority or Other||Difference in LSM: D. farinae|0.25|||<|0.001|2-Sided|95.0|0.16|0.33|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.||
1654025|NCT01644617|3043558|Superiority or Other||Difference in LSM: D. farinae|0.32|||<|0.001|2-Sided|95.0|0.23|0.42|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.||
1654026|NCT01644617|3043558|Superiority or Other||Difference in LSM: D. pteronyssinus|0.19|||<|0.001|2-Sided|95.0|0.12|0.25|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.||
1654058|NCT01644500|3043584|Superiority or Other (legacy)|||||||0.245||||||Treatment comparison for SBP.|Mixed Models Analysis||||
1654027|NCT01644617|3043558|Superiority or Other||Difference in LSM: D. pteronyssinus|0.23|||<|0.001|2-Sided|95.0|0.13|0.33|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.||
1654028|NCT01644617|3043559|Superiority or Other||Difference in LSM: D. farinae|0.39|||<|0.001|2-Sided|95.0|0.3|0.48|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.||
1654029|NCT01644617|3043559|Superiority or Other||Difference in LSM: D. farinae|0.52|||<|0.001|2-Sided|95.0|0.41|0.64|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.||
1654030|NCT01644617|3043559|Superiority or Other||Difference in LSM: D. pteronyssinus|0.42|||<|0.001|2-Sided|95.0|0.33|0.52|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.||
1654031|NCT01644617|3043559|Superiority or Other||Difference in LSM: D. pteronyssinus|0.55|||<|0.001|2-Sided|95.0|0.43|0.68|||ANOVA||Analysis by ANOVA with treatment as fixed effect and adjusted for different error variation for each treatment group.||
1654032|NCT01644617|3043562|Superiority or Other||Difference in LSM|-0.34||||0.235|2-Sided|95.0|-0.9|0.22|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654033|NCT01644617|3043562|Superiority or Other||Difference in LSM|-0.61||||0.023|2-Sided|95.0|-1.14|-0.09|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654034|NCT01644617|3043563|Superiority or Other||Difference in LSM|-0.13||||0.691|2-Sided|95.0|-0.79|0.52|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654035|NCT01644617|3043563|Superiority or Other||Difference in LSM|-0.53||||0.082|2-Sided|95.0|-1.13|0.07|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654036|NCT01644617|3043564|Superiority or Other||Difference in LSM|-0.77||||0.023|2-Sided|95.0|-1.43|-0.11|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654037|NCT01644617|3043564|Superiority or Other||Difference in LSM|-1.27|||<|0.001|2-Sided|95.0|-1.92|-0.62|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654038|NCT01644617|3043565|Superiority or Other||Difference in LSM|-0.83||||0.181|2-Sided|95.0|-2.06|0.4|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654039|NCT01644617|3043565|Superiority or Other||Difference in LSM|-1.97||||0.004|2-Sided|95.0|-3.3|-0.64|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654040|NCT01644617|3043566|Superiority or Other||Difference in LSM|-1.37||||0.091|2-Sided|95.0|-2.96|0.22|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654041|NCT01644617|3043566|Superiority or Other||Difference in LSM|-2.62|||<|0.001|2-Sided|95.0|-4.12|-1.13|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654042|NCT01644617|3043567|Superiority or Other||Difference in LSM|-2.65||||0.003|2-Sided|95.0|-4.35|-0.95|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654043|NCT01644617|3043567|Superiority or Other||Difference in LSM|-4.84|||<|0.001|2-Sided|95.0|-6.59|-3.09|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654044|NCT01644617|3043568|Superiority or Other||Difference in LSM|-0.54||||0.198|2-Sided|95.0|-1.38|0.29|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654045|NCT01644617|3043568|Superiority or Other||Difference in LSM|-1.37||||0.007|2-Sided|95.0|-2.34|-0.39|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654046|NCT01644617|3043569|Superiority or Other||Difference in LSM|-1.23||||0.032||95.0|-2.36|-0.11|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654047|NCT01644617|3043569|Superiority or Other||Difference in LSM|-2.08|||<|0.001|2-Sided|95.0|-3.14|-1.03|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654048|NCT01644617|3043570|Superiority or Other||Difference in LSM|-1.98||||0.003|2-Sided|95.0|-3.24|-0.72|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654049|NCT01644617|3043570|Superiority or Other||Difference in Least Squares Means (LSM)|-3.62|||<|0.001|2-Sided|95.0|-4.85|-2.39|||ANCOVA||Analysis by ANCOVA with treatment and baseline endpoint score as fixed effects and adjusted for different error variation for each treatment group.||
1654050|NCT01644500|3043579|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1654051|NCT01644500|3043579|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1654052|NCT01644500|3043580|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1654053|NCT01644500|3043580|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1654054|NCT01644500|3043583|Superiority or Other (legacy)|||||||0.035|||||||Mixed Models Analysis||||
1654055|NCT01644500|3043583|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1654056|NCT01644500|3043584|Superiority or Other (legacy)|||||||0.619||||||Treatment comparison for DBP.|Mixed Models Analysis||||
1654057|NCT01644500|3043584|Superiority or Other (legacy)|||||||0.717||||||Treatment comparison for DBP.|Mixed Models Analysis||||
1654059|NCT01644500|3043584|Superiority or Other (legacy)|||||||0.18||||||Treatment comparison for SBP.|Mixed Models Analysis||||
1654060|NCT01644500|3043587|Superiority||Mean Difference (Net)|-6.79||||0.007|2-Sided|95.0|-11.68|-1.89|||ANCOVA|||C-Peptide-Based HOMA2-%S|
1654061|NCT01644500|3043587|Superiority||Mean Difference (Net)|-1.39||||0.576|2-Sided|95.0|-6.27|3.49|||ANCOVA|||C-Peptide-Based HOMA2-%S|
1654062|NCT01644500|3043587|Superiority or Other (legacy)||Mean Difference (Net)|-3.14||||0.318|2-Sided|95.0|-9.3|3.03|||ANCOVA|||Insulin-Based HOMA2%S|
1654063|NCT01644500|3043587|Superiority or Other (legacy)||Mean Difference (Net)|0.34||||0.913|2-Sided|95.0|-5.83|6.51|||ANCOVA|||Insulin-Based HOMA2%S|
1654064|NCT01644500|3043588|Superiority||Mean Difference (Net)|9.99|||<|0.001|2-Sided|95.0|5.36|14.62|||ANCOVA|||C-Peptide-Based HOMA2-%B|
1654065|NCT01644500|3043588|Superiority||Mean Difference (Net)|16.44|||<|0.001|2-Sided|95.0|11.81|21.06|||ANCOVA|||C-Peptide-Based HOMA2-%B|
1654066|NCT01644500|3043588|Superiority or Other (legacy)||Mean Difference (Net)|7.92|||<|0.012|2-Sided|95.0|1.78|14.06|||ANCOVA|||Insulin HOMA2%B|
1654067|NCT01644500|3043588|Superiority or Other (legacy)||Mean Difference (Net)|17.41|||<|0.001|2-Sided|95.0|11.27|23.55|||ANCOVA|||Insulin HOMA2-%B|
1654068|NCT01644500|3043589|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact||||
1654069|NCT01644500|3043589|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact||||
1654070|NCT01644500|3043590|Superiority or Other (legacy)|||||||0.006||||||Treatment comparison for nocturnal hypoglycemic episodes. Nocturnal hypoglycemic episodes are rounded off to 2 decimal places.|Negative binomial regression model||||
1654071|NCT01644500|3043590|Superiority or Other (legacy)|||||||0.008||||||Treatment comparison for nocturnal hypoglycemic episodes. Nocturnal hypoglycemic episodes are rounded off to 2 decimal places.|Negative binomial regression model||||
1654072|NCT01644500|3043590|Superiority or Other (legacy)||||||<|0.001||||||Treatment comparison for all hypoglycemic episodes.|Negative binomial regression model||||
1654073|NCT01644500|3043590|Superiority or Other (legacy)||||||<|0.001||||||Treatment comparison for all hypoglycemic episodes.|Negative binomial regression model||||
1654074|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-0.66|||<|0.001|2-Sided|95.0|-1.03|-0.29||Treatment comparison for bedtime.|Mixed Models Analysis||||
1654075|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-1.19|||<|0.001|2-Sided|95.0|-1.56|-0.82||Treatment comparison for bedtime.|Mixed Models Analysis||||
1654076|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-0.45|||<|0.03|2-Sided|95.0|-0.85|-0.04||Treatment comparison for evening (2 hours post-prandial) meal.|Mixed Models Analysis||||
1654077|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-1.27|||<|0.001|2-Sided|95.0|-1.68|-0.87||Treatment comparison for evening (2 hours post-prandial) meal.|Mixed Models Analysis||||
1654078|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-0.08|||<|0.638|2-Sided|95.0|-0.41|0.25||Treatment comparison for evening (pre-prandial) meal.|Mixed Models Analysis||||
1654079|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-0.67|||<|0.001|2-Sided|95.0|-1.0|-0.34||Treatment comparison for evening (pre-prandial) meal.|Mixed Models Analysis||||
1654080|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-0.81|||<|0.001|2-Sided|95.0|-1.24|-0.39||Treatment comparison of midday (2 hours post-prandial) meal.|Mixed Models Analysis||||
1654081|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-1.56|||<|0.001|2-Sided|95.0|-1.99|-1.13||Treatment comparison of midday (2 hours post-prandial) meal.|Mixed Models Analysis||||
1654082|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-0.06|||<|0.74|2-Sided|95.0|-0.43|0.31||Treatment comparison for midday (pre-prandial) meal.|Mixed Models Analysis||||
1654083|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-0.73|||<|0.001|2-Sided|95.0|-1.1|-0.36||Treatment comparison for midday (pre-prandial) meal.|Mixed Models Analysis||||
1654084|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-0.55|||<|0.015|2-Sided|95.0|-0.99|-0.11||Treatment comparison for morning (2 hours post-prandial) meal.|Mixed Models Analysis||||
1654085|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-1.36|||<|0.001|2-Sided|95.0|-1.8|-0.92||Treatment comparison for morning (2 hours post-prandial) meal.|Mixed Models Analysis||||
1654086|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-0.12|||<|0.304|2-Sided|95.0|-0.34|0.11||Treatment comparison for morning (fasting).|Mixed Models Analysis||||
1654087|NCT01644500|3043591|Superiority or Other (legacy)||Mean Difference (Net)|-0.67|||<|0.001|2-Sided|95.0|-0.89|-0.45||Treatment comparison for morning (fasting).|Mixed Models Analysis||||
1654088|NCT01644500|3043592|Superiority or Other (legacy)||Mean Difference (Net)|-0.38||||0.022|2-Sided|95.0|-0.7|-0.05|||Mixed Models Analysis||||
1654089|NCT01644500|3043592|Superiority or Other (legacy)||Mean Difference (Net)|-0.83|||<|0.001|2-Sided|95.0|-1.15|-0.51|||Mixed Models Analysis||||
1654090|NCT01644500|3043593|Superiority or Other (legacy)||Odds Ratio (OR)|1.6||||0.192|2-Sided|95.0|1.1|2.5||Treatment comparison for HbA1c <7.0%.|Fisher Exact||||
1654091|NCT01644500|3043593|Superiority or Other (legacy)||Odds Ratio (OR)|2.9|||<|0.001|2-Sided|95.0|1.8|4.5||Treatment comparison for HbA1c <7.0%.|Fisher Exact||||
1654092|NCT01644500|3043593|Superiority or Other (legacy)||Odds Ratio (OR)|1.6|||<|0.001|2-Sided|95.0|1.0|2.3||Treatment comparison for HbA1c ≤6.5%.|Fisher Exact||||
1654093|NCT01644500|3043593|Superiority or Other (legacy)||Odds Ratio (OR)|2.7|||<|0.001|2-Sided|5.0|1.8|4.1||Treatment comparison for HbA1c ≤6.5%.|Fisher Exact||||
1654094|NCT01644500|3043594|Non-Inferiority or Equivalence (legacy)|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.32|||<|0.001|2-Sided|95.0|-0.5|-0.13|||Mixed Models Analysis||||
1654095|NCT01644500|3043594|Non-Inferiority or Equivalence (legacy)|Analyses were based on a pre-defined non-inferiority margin of 0.4%.|Mean Difference (Net)|-0.58|||<|0.001|2-Sided|95.0|-0.76|-0.39|||Mixed Models Analysis||||
1654838|NCT01633853|3045066|Superiority or Other|||||||0.554||||||t=-0.593|t-test, 2 sided|||The levels of blood calcium at the 24th month of following up were compared between two groups.|
1654096|NCT01644474|3043602|Superiority or Other||Adjusted Mean Difference|-4.4||||0.4013|2-Sided|95.0|-14.8|5.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654097|NCT01644474|3043603|Superiority or Other||Odds Ratio (OR)|69.8||||0.0001|2-Sided|95.0|8.8|556.0||Threshold for significance was ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654098|NCT01644474|3043604|Superiority or Other||Odds Ratio (OR)|34.8|||<|0.0001|2-Sided|95.0|8.7|139.0||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654099|NCT01644474|3043605|Superiority or Other||LS Mean Difference|-18.3|||<|0.0001|2-Sided|95.0|-23.1|-13.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654100|NCT01644474|3043606|Superiority or Other||LS Mean Difference|-25.8|||<|0.0001|2-Sided|95.0|-32.4|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654101|NCT01644474|3043607|Superiority or Other||LS Mean Difference|-25.7|||<|0.0001|2-Sided|95.0|-31.5|-19.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654102|NCT01644474|3043608|Superiority or Other||LS Mean Difference|-18.7|||<|0.0001|2-Sided|95.0|-24.7|-12.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654103|NCT01644474|3043609|Superiority or Other||LS Mean Difference|-25.5|||<|0.0001|2-Sided|95.0|-33.5|-17.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654104|NCT01644474|3043610|Superiority or Other||LS Mean Difference|-25.8|||<|0.0001|2-Sided|95.0|-32.3|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654105|NCT01644474|3043611|Superiority or Other||LS Mean Difference|-28.5|||<|0.0001|2-Sided|95.0|-35.7|-21.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|
1654106|NCT01644474|3043612|Superiority or Other||LS Mean Difference|-31.6|||<|0.0001|2-Sided|95.0|-40.2|-23.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.|
1654107|NCT01644331|3043652|Superiority or Other||Kaplan Meier|0.26||||0.709|2-Sided|95.0|0.21|0.32|||Log Rank||||
1654108|NCT01644331|3043653|Superiority or Other|||||||0.373|||||||Wilcoxon (Mann-Whitney)||||
1654109|NCT01644331|3043654|Superiority or Other|||||||0.037|||||||Chi-squared||||
1654110|NCT01644331|3043655|Superiority or Other|||||||0.12||||||72 hrs|Chi-squared||||
1654111|NCT01644331|3043655|Superiority or Other|||||||0.585||||||48 hrs|Chi-squared||||
1654112|NCT01644331|3043655|Superiority or Other|||||||0.471||||||24 hours|Chi-squared||||
1654113|NCT01644331|3043656|Superiority or Other||Slope|0.28||||0.303|2-Sided|95.0|-0.26|0.82|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.|
1654114|NCT01644331|3043657|Superiority or Other||Slope|-0.67||||0.241|2-Sided|95.0|-1.79|0.45|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.|
1654115|NCT01644331|3043658|Superiority or Other|||||||0.334|||||||Chi-squared||||
1654116|NCT01644331|3043659|Superiority or Other|||||||0.148|||||||Chi-squared||||
1654117|NCT01644331|3043660|Superiority or Other||Kaplan Meier|0.98||||0.334|2-Sided|95.0|0.96|0.99|||Log Rank||||
1654118|NCT01644331|3043661|Superiority or Other|||||||0.206|||||||Chi-squared|||This is a repeated measures analysis so all rows (visits) are taken into account.|
1654119|NCT01644331|3043662|Superiority or Other||Slope|-493.21||||0.157|2-Sided|95.0|-1176.96|190.55|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.|
1654120|NCT01644331|3043663|Superiority or Other||Slope|0.99||||0.43|2-Sided|95.0|-1.47|3.44|||Mixed Models Analysis|||This a repeated measure analysis so all rows (visits) are taken into account.|
1654121|NCT01644331|3043664|Superiority or Other||Slope|0.19||||0.021|2-Sided|95.0|0.03|0.34|||Mixed Models Analysis|||This is a repeated measures analysis so all rows (visits) are taken into account.|
1654122|NCT01644331|3043665|Superiority or Other|||||||0.315|||||||Chi-squared||||
1654123|NCT01644188|3043692|Superiority or Other||Adjusted Mean Difference|-0.3||||0.9117|2-Sided|95.0|-5.1|4.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654124|NCT01644188|3043693|Superiority or Other||LS Mean Difference|8.1|||<|0.0001|2-Sided|95.0|5.4|10.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654237|NCT01642147|3043990|Superiority or Other||||||<|0.001||||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 30min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"|
1654125|NCT01644188|3043694|Superiority or Other||Adjusted Mean Difference|-21.7|||<|0.0001|2-Sided|95.0|-26.4|-17.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654126|NCT01644188|3043695|Superiority or Other||Odds Ratio (OR)|5.9|||<|0.0001|2-Sided|95.0|3.9|8.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654127|NCT01644188|3043696|Superiority or Other||Odds Ratio (OR)|5.4|||<|0.0001|2-Sided|95.0|3.7|7.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by Logistic regression model.|Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654128|NCT01644188|3043697|Superiority or Other||LS Mean Difference|-31.2|||<|0.0001|2-Sided|95.0|-36.3|-26.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654129|NCT01644188|3043698|Superiority or Other||LS Mean Difference|-14.3|||<|0.0001|2-Sided|95.0|-17.1|-11.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654130|NCT01644188|3043699|Superiority or Other||LS Mean Difference|-22.0|||<|0.0001|2-Sided|95.0|-25.6|-18.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654131|NCT01644188|3043700|Superiority or Other||LS Mean Difference|-22.5|||<|0.0001|2-Sided|95.0|-25.7|-19.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654132|NCT01644188|3043701|Superiority or Other||LS Mean Difference|-14.7|||<|0.0001|2-Sided|95.0|-17.7|-11.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654133|NCT01644188|3043702|Superiority or Other||LS Mean Difference|-23.5|||<|0.0001|2-Sided|95.0|-27.2|-19.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654134|NCT01644188|3043703|Superiority or Other||LS Mean Difference|-22.9|||<|0.0001|2-Sided|95.0|-26.9|-18.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654135|NCT01644188|3043704|Superiority or Other||LS Mean Difference|-23.0|||<|0.0001|2-Sided|95.0|-26.5|-19.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654136|NCT01644188|3043705|Superiority or Other||LS Mean Difference|-22.4|||<|0.0001|2-Sided|95.0|-26.0|-18.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654137|NCT01644188|3043706|Superiority or Other||LS Mean Difference|-29.7|||<|0.0001|2-Sided|95.0|-33.8|-25.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654138|NCT01644188|3043707|Superiority or Other||LS Mean Difference|-29.4|||<|0.0001|2-Sided|95.0|-33.7|-25.1||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654139|NCT01644188|3043708|Superiority or Other||LS Mean Difference|-30.6|||<|0.0001|2-Sided|95.0|-34.9|-26.2||Threshold for significance ≤0.05|Mixed Models Analysis||Alirocumab vs. ezetimibe|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|
1654140|NCT01644188|3043709|Superiority or Other||LS Mean Difference|-29.8|||<|0.0001|2-Sided|95.0|-34.4|-25.3||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. ezetimibe|Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.|
1654141|NCT01644175|3043715|Superiority or Other||Adjusted Mean Difference|-0.6||||0.8699|2-Sided|95.0|-8.3|7.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654142|NCT01644175|3043716|Superiority or Other||LS Mean Difference|7.3||||0.0001|2-Sided|95.0|3.6|11.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654143|NCT01644175|3043717|Superiority or Other||Adjusted Mean Difference|-14.6|||<|0.0001|2-Sided|95.0|-21.3|-7.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654144|NCT01644175|3043718|Superiority or Other||Odds Ratio (OR)|50.0|||<|0.0001|2-Sided|95.0|20.6|121.0||Threshold for significance ≤ 0.05|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654302|NCT01641653|3044148|Superiority or Other|||||||0.12||||||Chi-square with continuity correction|Chi-squared, Corrected||||
1654145|NCT01644175|3043719|Superiority or Other||Odds Ratio (OR)|38.5|||<|0.0001|2-Sided|95.0|16.5|89.8||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654146|NCT01644175|3043720|Superiority or Other||LS Mean Difference|-43.0|||<|0.0001|2-Sided|95.0|-51.6|-34.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654147|NCT01644175|3043721|Superiority or Other||LS Mean Difference|-26.4|||<|0.0001|2-Sided|95.0|-31.1|-21.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654148|NCT01644175|3043722|Superiority or Other||LS Mean Difference|-40.1|||<|0.0001|2-Sided|95.0|-46.2|-33.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654149|NCT01644175|3043723|Superiority or Other||LS Mean Difference|-38.2|||<|0.0001|2-Sided|95.0|-43.7|-32.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654150|NCT01644175|3043724|Superiority or Other||LS Mean Difference|-25.0|||<|0.0001|2-Sided|95.0|-29.3|-20.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654151|NCT01644175|3043725|Superiority or Other||LS Mean Difference|-40.4|||<|0.0001|2-Sided|95.0|-46.4|-34.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654152|NCT01644175|3043726|Superiority or Other||LS Mean Difference|-37.5|||<|0.0001|2-Sided|95.0|-43.5|-31.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654153|NCT01644175|3043727|Superiority or Other||LS Mean Difference|-37.5|||<|0.0001|2-Sided|95.0|-43.0|-32.0||Threshold for significance ≤0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654154|NCT01644175|3043728|Superiority or Other||LS Mean Difference|-35.8|||<|0.0001|2-Sided|95.0|-41.3|-30.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654155|NCT01644175|3043729|Superiority or Other||LS Mean Difference|-49.3|||<|0.0001|2-Sided|95.0|-55.3|-43.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654156|NCT01644175|3043730|Superiority or Other||LS Mean Difference|-47.4|||<|0.0001|2-Sided|95.0|-53.6|-41.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1654157|NCT01644175|3043731|Superiority or Other||LS Mean Difference|-49.9|||<|0.0001|2-Sided|95.0|-56.2|-43.6||Threshold for significance was ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|
1654158|NCT01644175|3043732|Superiority or Other||LS Mean Difference|-45.9|||<|0.0001|2-Sided|95.0|-52.5|-39.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.|
1654159|NCT01643876|3043792|Superiority or Other||Median Difference (Net)|-57.5|||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: in individuals with denture stomatitis, there are no difference in the number of Candida Colony-Forming Units (CFUs), before and 3 months after palatal brushing.|
1654160|NCT01643876|3043793|Superiority or Other||Median Difference (Net)|-1.5|||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: in individuals with denture stomatitis, there are no difference in the extent of palatal inflammation before and 3 months after palatal brushing. Assuming that the minimal practically important pre/post difference in the mean change score is 20 percent and the standard deviation of the distribution of the change in score is 0.8, a sample size of 44 participants is required to ensure a power of 90 % of rejecting the null hypothesis if it is indeed false.|
1654161|NCT01643850|3043816|Superiority||Mean Difference (Net)|0.69||||0.01|2-Sided|95.0|0.52|0.91|||ANCOVA||||
1654162|NCT01643850|3043816|Superiority||Median Difference (Net)|0.78||||0.117|2-Sided|95.0|0.57|1.07|||ANCOVA||||
1654163|NCT01643850|3043816|Superiority||Mean Difference (Net)|0.98||||0.915|2-Sided|95.0|0.71|1.36|||ANCOVA||||
1654164|NCT01643798|3043818|Superiority or Other|||||||0.794|||||||ANOVA||||
1654165|NCT01643798|3043818|Superiority or Other|||||||0.0003|||||||ANOVA||||
1654166|NCT01643798|3043819|Superiority or Other|||||||0.04|||||||ANOVA||||
1654167|NCT01643798|3043819|Superiority or Other||||||<|0.001|||||||ANOVA||||
1654168|NCT01643616|3043845|Superiority or Other||Percentage Difference|26.2||||0.05|||||||Fisher Exact||For success rate with supplementation the difference between group US (98.2%) and group NS (72%) is 26.2%.|For sample size calculation we assumed a significance level of 0.05 and a success rate derived from clinical data of 75% in the nerve stimulation group and of 90% in the ultrasound group. With a group ratio of 1:1 and a power of 0.8, the required sample size was at least 226. For statistical analysis we used the exact Fisher test as a distribution-free, non-parametric test method.|
1654169|NCT01643616|3043846|Superiority or Other||Mean Difference (Final Values)|22.9|||<|0.05|2-Sided|95.0|13.6|31.1|||Log Rank|||We used the log-rank test to compare the onset times. The significance level was defined with p<0.05.|
1654170|NCT01643616|3043847|Superiority or Other||Percentage Difference|33.0|||<|0.05|||||||Fisher Exact||For success rate without supplementation the difference between group US (94.9%) and group NS (61.9%) is 33%.|For sample size calculation we assumed a significance level of 0.05 and a success rate derived from clinical data of 75% in the nerve stimulation group and of 90% in the ultrasound group. With a group ratio of 1:1 and a power of 0.8, the required sample size was at least 226. For statistical analysis we used the exact Fisher test as a distribution-free, non-parametric test method.|
1654171|NCT01642914|3043858|Superiority or Other||Odds Ratio (OR)|2.23||||0.0264|2-Sided|95.0|1.09|4.56||p-values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel||||
1654172|NCT01642914|3043864|Superiority or Other||Cox Proportional Hazard|1.24||||0.047|2-Sided|95.0|0.99|1.55|||Log Rank|Log-rank test stratified by geographic region.|||
1654173|NCT01642914|3043864|Superiority or Other||Cox Proportional Hazard|1.37||||0.0054|2-Sided|95.0|1.09|1.72|||Log Rank|Log-rank test stratified by geographic region.|||
1654174|NCT01642914|3043865|Superiority or Other||Risk Difference (RD)|0.17||||0.0022|2-Sided|95.0|0.064|0.227||p-Values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel||||
1654175|NCT01642914|3043865|Superiority or Other||Risk Difference (RD)|0.193||||0.0006|2-Sided|95.0|0.086|0.3||p-Values were obtained from the Cochran-Mantel-Haenszel tests controlling for geographic region, comparing each linaclotide dose versus placebo in a pairwise manner.|Cochran-Mantel-Haenszel||||
1654176|NCT01642914|3043878|Superiority or Other|||||||0.0012|||||||Kolmogorov-Smirnov|Kolmogorov-Smirnov test for equality of distribution|||
1654177|NCT01642914|3043878|Superiority or Other|||||||0.0054|||||||Kolmogorov-Smirnov|Kolmogorov-Smirnov test for equality of distribution|||
1654178|NCT01642485|3043900|Superiority or Other||Median Difference (Final Values)|-6.8|||||2-Sided|90.0|-9.3|-4.3|||||||
1654179|NCT01642485|3043900|Superiority or Other||Mean Difference (Final Values)|-7.9|||||2-Sided|90.0|-10.4|-5.5|||||||
1654180|NCT01642485|3043900|Superiority or Other|||||||0.05|||||||t-test, 1 sided|||The relevant confirmatory null hypotheses could all be rejected on the 5% level (one sided), i.e. a difference in QTcF between continental breakfast and placebo; between FDA breakfast and placebo could be ascertained.|
1654181|NCT01642485|3043901|Superiority or Other|||||||0.05|||||||t-test, 1 sided|||The effect of insulin, C-peptide and glucose on QTcF was investigated using linear mixed effect concentration–response models with the double difference of QTcF (difference to time matched placebo of the change from average baseline) as dependent variable and up to two of the variables change from time matched placebo in insulin, C-peptide and glucose as covariates.|
1654182|NCT01642277|3043944|Superiority or Other||Standardized test statistic (z-score)|-1.85||||0.07|2-Sided||||||Wilcoxon (Mann-Whitney)|||For the pelvic organ prolapse distress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in pelvic organ prolapse distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) pelvic organ prolapse distress than the other group.|
1654183|NCT01642277|3043944|Superiority or Other||Standardized test statistic (z-score)|-1.92||||0.06|2-Sided||||||Wilcoxon (Mann-Whitney)|||For the posterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in posterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) posterior pelvic floor disease severity than the other group.|
1654184|NCT01642277|3043944|Superiority or Other||Standardized test statistic (z-score)|-0.23||||0.82|2-Sided||||||Wilcoxon (Mann-Whitney)|||For the anterior score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in anterior pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) anterior pelvic floor disease severity than the other group.|
1654185|NCT01642277|3043944|Superiority or Other||Standardized test statistic (z-score)|-1.68||||0.09|2-Sided||||||Wilcoxon (Mann-Whitney)|||For the general score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in general pelvic floor disease severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) general pelvic floor disease severity than the other group.|
1654186|NCT01642277|3043944|Superiority or Other||Standardized test statistic (z-score)|-1.69||||0.09|2-Sided||||||Wilcoxon (Mann-Whitney)|||For the urinary distress inventory score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in urinary distress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) urinary distress than the other group.|
1654187|NCT01642277|3043944|Superiority or Other||Standardized test statistic (z-score)|-1.59||||0.11|2-Sided||||||Wilcoxon (Mann-Whitney)|||For the stress score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in stress, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) stress than the other group.|
1654188|NCT01642277|3043944|Superiority or Other||Standardized test statistic (z-score)|-1.8||||0.07|2-Sided||||||Wilcoxon (Mann-Whitney)|||For the irritative score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in irritation, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) irritation than the other group.|
1654303|NCT01641653|3044149|Superiority or Other||Median Difference (Final Values)|10.0||||0.56|2-Sided||||||Wilcoxon (Mann-Whitney)|||percent change in glucose levels from preoperative level to maximum perioperative measurement level|
1654189|NCT01642277|3043944|Superiority or Other||Standardized test statistic (z-score)|-0.74||||0.46|2-Sided||||||Wilcoxon (Mann-Whitney)|||For the obstructive discomfort score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size in the non-responder group (n = 13). The null hypothesis is that there is no difference between the two groups in obstructive discomfort, and and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) obstructive discomfort than the other group.|
1654190|NCT01642277|3043945|Superiority or Other||Standardized test statistic (z-score)|2.03||||0.04|2-Sided||||||Wilcoxon (Mann-Whitney)|||For the overall health related quality of life (HRQL) score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of HRQL scores. The null hypothesis is that there is no difference between the two groups in health related quality of life, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) health realted quality of life than the other group.|
1654191|NCT01642277|3043945|Superiority or Other||Standardized test statistic (z-score)|2.02||||0.04|2-Sided||||||Wilcoxon (Mann-Whitney)|||For social score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of social scores. The null hypothesis is that there is no difference between the two groups in social scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) social scores than the other group.|
1654192|NCT01642277|3043945|Superiority or Other||Standardized test statistic (z-score)|0.9||||0.37|2-Sided||||||Wilcoxon (Mann-Whitney)|||For the sleep score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of sleep scores. The null hypothesis is that there is no difference between the two groups in sleep scores, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) sleep scores than the other group.|
1654193|NCT01642277|3043945|Superiority or Other||Standardized test statistic (z-score)|2.176||||0.03|2-Sided||||||Wilcoxon (Mann-Whitney)|||For the concern score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outlier of the concern scores. The null hypothesis is that there is no difference between the two groups in their concern, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) concern than the other group.|
1654194|NCT01642277|3043945|Superiority or Other||Standardized test statistic (z-score)|2.06||||0.04|2-Sided||||||Wilcoxon (Mann-Whitney)|||For coping score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size, non-normal distributions, and outliers of coping scores. The null hypothesis is that there is no difference between the two groups in coping, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) coping than the other group.|
1654195|NCT01642277|3043945|Superiority or Other||Standardized test statistic (z-score)|-1.94||||0.052|2-Sided||||||Wilcoxon (Mann-Whitney)|||For symptom-severity score, the non-parametric Mann-Whitney test was used to compare the responder and non-responder groups due to low sample size and non-normal distributions of symptom severity scores. The null hypothesis is that there is no difference between the two groups in symptom severity, and the two-sided alternative hypothesis is that one of the two groups has higher (or lower) symptom severity than the other group.|
1654196|NCT01642251|3043947|Superiority|||||||0.13|||||||t-test, 2 sided||||
1654197|NCT01642251|3043949|Superiority||Hazard Ratio (HR)|0.83||||0.17|2-Sided|80.0|0.64|1.07|||Regression, Cox|stratified on the stratification factors used for randomization|||
1654198|NCT01642251|3043950|Superiority|||||||0.028||||||p value for the interaction by treatment and stratification factor|Regression, Cox|||If there was a significant treatment-by-stratification factor interaction, the results would be reported separately for each stratum. Significance was defined as the p value was less than 0.05.|
1654199|NCT01642251|3043950|Superiority||Hazard Ratio (HR)|0.81||||0.18|2-Sided|80.0|0.6|1.09||one-sided p value|Regression, Cox|adjusted for ECOG performance status, abnormal protein in the Cox proportional hazard model||The significance test reported here was for treatment arms comparison in patients not in the male/abnormal LDH stratum.|
1654200|NCT01642251|3043950|Superiority||Hazard Ratio (HR)|0.34|||<|0.001|2-Sided|80.0|0.22|0.51||one-sided p value|Regression, Cox|adjusted for ECOG performance status, abnormal protein in the Cox proportional hazard model||The significance test reported here was for treatment arms comparison in patients within the male/abnormal LDH stratum|
1654201|NCT01642212|3043960|Superiority or Other (legacy)||LS mean difference|-1.8||||0.1091|2-Sided|95.0|-4.006|0.41||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 16|
1654202|NCT01642212|3043960|Superiority or Other (legacy)||LS mean difference|-1.92||||0.0662|2-Sided|95.0|-3.974|0.132||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12|
1654203|NCT01642212|3043960|Superiority or Other (legacy)||LS mean difference|-0.73||||0.4835|2-Sided|95.0|-2.806|1.339||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8|
1654204|NCT01642212|3043961|Superiority or Other (legacy)||LS mean difference|0.01||||0.9239|2-Sided|95.0|-0.199|0.219||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 16|
1654205|NCT01642212|3043961|Superiority or Other (legacy)||LS mean difference|-0.03||||0.8046|2-Sided|95.0|-0.269|0.21||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12|
1654206|NCT01642212|3043961|Superiority or Other (legacy)||LS mean difference|-0.09||||0.1686|2-Sided|95.0|-0.222|0.04||Estimates are determined using an ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8|
1654207|NCT01642212|3043962|Superiority or Other (legacy)|||||||0.7817|||||||Wilcoxon (Mann-Whitney)||||
1654208|NCT01642212|3043963|Superiority or Other (legacy)|||||||0.0165|||||||Pearson's chi-square|||Analysis of >/= 50% DSQ+pain score reduction|
1654209|NCT01642212|3043963|Superiority or Other (legacy)|||||||0.0606|||||||Pearson's chi-square|||Analysis of >/= 30% DSQ+pain score reduction|
1655089|NCT01625091|3046226|Superiority|||||||0.7|||||||t-test, 2 sided||||
1654210|NCT01642212|3043965|Superiority or Other (legacy)|||||||0.16||||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. Both responses (no change, worsened) were analyzed collectively.|Cochran-Mantel-Haenszel|||Analysis of symptoms of participants with no symptoms at baseline|
1654211|NCT01642212|3043968|Superiority or Other (legacy)|||||||0.2886||||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of vomiting|
1654212|NCT01642212|3043968|Superiority or Other (legacy)|||||||0.5219||||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of nausea|
1654213|NCT01642212|3043968|Superiority or Other (legacy)|||||||0.5257||||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of abdominal pain|
1654214|NCT01642212|3043968|Superiority or Other (legacy)|||||||0.4963||||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of regurgitation|
1654215|NCT01642212|3043968|Superiority or Other (legacy)|||||||0.8029||||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of chest pain|
1654216|NCT01642212|3043968|Superiority or Other (legacy)|||||||0.1947||||||P-value for comparison of the treatment difference at baseline vs. final treatment evaluation was determined by a Cochran-Mantel-Haenszel row mean score test. All responses (improved, no change, worsened) were analyzed collectively for each symptom.|Cochran-Mantel-Haenszel|||Analysis of heartburn|
1654217|NCT01642212|3043969|Superiority or Other (legacy)|||||||0.117||||||P-value for comparison of the treatment difference was determined by Cochran-Mantel-Haenszel row mean score test.|Cochran-Mantel-Haenszel|||Analysis of distribution of scores across all responses|
1654218|NCT01642212|3043970|Superiority or Other (legacy)||LS mean difference|-18.44||||0.0015|2-Sided|95.0|-29.593|-7.293||LS mean estimates were based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA||||
1654219|NCT01642212|3043971|Superiority or Other (legacy)||LS mean difference|-67.38|||<|0.0001|2-Sided|95.0|-93.573|-41.18||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of distal eosinophil count|
1654220|NCT01642212|3043971|Superiority or Other (legacy)||LS mean difference|-59.56|||<|0.0001|2-Sided|95.0|-84.173|-34.948||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of mid- eosinophil count|
1654221|NCT01642212|3043971|Superiority or Other (legacy)||LS mean difference|-35.5|||<|0.0002|2-Sided|95.0|-53.438|-17.57||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA|||Analysis of proximal eosinophil count|
1654222|NCT01642212|3043972|Superiority or Other (legacy)||LS mean difference|-3.76|||<|0.0001|2-Sided|95.0|-5.172|-2.358||LS mean estimates based on the ANCOVA model including treatment group as a factor and baseline value as a covariate.|ANCOVA||||
1654223|NCT01642212|3043973|Superiority or Other (legacy)||LS mean difference|-22.34|||<|0.0001|2-Sided|95.0|-30.345|-14.334|||ANCOVA|LS mean based on the ANCOVA model including treatment group as a factor and baseline as a covariate.|||
1654224|NCT01642212|3043974|Superiority or Other (legacy)|||||||0.0199|||||||Fisher Exact|||Analysis of response and >/= 50% DSQ score reduction|
1654225|NCT01642212|3043974|Superiority or Other (legacy)|||||||0.0026|||||||Fisher Exact|||Analysis of response and >/= 30% DSQ score reduction|
1654226|NCT01642212|3043975|Superiority or Other (legacy)|||||||0.0275|||||||Pearson's chi-square|||Analysis of >/= 50% DSQ score reduction|
1654227|NCT01642212|3043975|Superiority or Other (legacy)|||||||0.0206|||||||Pearson's chi-square|||Analysis of >/= 30% DSQ score reduction|
1654228|NCT01642212|3043976|Superiority or Other (legacy)||||||<|0.0001|||||||Fisher Exact|||Analysis of </= 1 Eosinophils/HPF|
1654229|NCT01642212|3043976|Superiority or Other (legacy)||||||<|0.0001|||||||Fisher Exact|||Analysis of </= 15 Eosinophils/HPF|
1654230|NCT01642212|3043978|Superiority or Other (legacy)||LS mean difference|-2.91||||0.2878|2-Sided|95.0|-8.322|2.501||LS mean estimates were determined using the ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 12|
1654231|NCT01642212|3043978|Superiority or Other (legacy)||LS mean difference|-2.49||||0.2649|2-Sided|95.0|-6.895|1.92||LS mean estimates were determined using the ANCOVA model including treatment group as a factor and baseline DSQ score as a covariate.|ANCOVA|||Analysis of Week 8|
1654232|NCT01642212|3043979|Superiority or Other (legacy)||LS mean difference|-6.75||||0.0096|2-Sided|95.0|-11.808|-1.687||LS mean estimates were determined using an ANCOVA model including treatment group as a factor and the baseline score as a covariate.|ANCOVA||||
1654233|NCT01642212|3043980|Superiority or Other (legacy)||||||<|0.0001|||||||Fisher Exact||||
1654234|NCT01642147|3043987|Superiority or Other||||||<|0.001||||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 120min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"|
1654235|NCT01642147|3043988|Superiority or Other||||||<|0.001||||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 90min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"|
1654236|NCT01642147|3043989|Superiority or Other||||||<|0.001||||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: mean blood flow velocity in middle cerebral artery of the 2 groups are the same 60min after extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"|
1654238|NCT01642147|3043991|Superiority or Other||||||<|0.001||||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same at extubation.~Power calculation: beta=0.2, alpha=0.05, two-tailed"|
1654239|NCT01642147|3043992|Superiority or Other|||||||0.554||||||Bonferroni correction is used when P-value is significant|Wilcoxon (Mann-Whitney)|||"H0: Mean Blood Flow Velocity in Middle Cerebral Artery of the 2 groups are the same before anesthesia.~Power calculation: beta=0.2, alpha=0.05, two-tailed"|
1654240|NCT01642004|3044000|Superiority or Other (legacy)||Hazard Ratio (HR)|0.45|||||2-Sided|95.0|0.23|0.89|||||HR = Nivolumab over Docetaxel; PD-L1 expression not quantifiable at baseline|PD-L1 expression not quantifiable at baseline|
1654241|NCT01642004|3044000|Superiority or Other (legacy)||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.52|1.08|||||HR = Nivolumab over Docetaxel; PD-L1 expression < 5%|PD-L1 expression < 5%|
1654242|NCT01642004|3044000|Superiority or Other (legacy)||Hazard Ratio (HR)|0.54|||||2-Sided|95.0|0.32|0.9|||||HR = Nivolumab over Docetaxel; PD-L1 expression >= 5%|PD-L1 expression >= 5%|
1654243|NCT01642004|3044001|Superiority or Other (legacy)||Odds Ratio (OR)|17.8|||||2-Sided|95.0|1.8|830.7|||||OR = Nivolumab over Docetaxel; PD-L1 expression not quantifiable at baseline|PD-L1 expression not quantifiable at baseline|
1654244|NCT01642004|3044001|Superiority or Other (legacy)||Odds Ratio (OR)|1.3|||||2-Sided|95.0|0.4|4.0|||||OR = Nivolumab over Docetaxel; PD-L1 expression < 5%|PD-L1 < 5%|
1654245|NCT01642004|3044001|Superiority or Other (legacy)||Odds Ratio (OR)|3.3|||||2-Sided|95.0|0.7|20.1|||||OR = Nivolumab over Docetaxel; PD-L1 expression >= 5%|PD-L1 expression >= 5%|
1654246|NCT01642004|3044002|Superiority or Other (legacy)||Hazard Ratio (HR)|0.39|||||2-Sided|95.0|0.19|0.82|||||HR = Nivolumab over Docetaxel; PD-L1 not quantifiable at baseline|PD-L1 expression not quantifiable at baseline|
1654247|NCT01642004|3044002|Superiority or Other (legacy)||Hazard Ratio (HR)|0.7|||||2-Sided|95.0|0.47|1.02|||||HR = Nivolumab over Docetaxel; PD-L1 expression < 5%|PD-L1 expression < 5%|
1654248|NCT01642004|3044002|Superiority or Other (legacy)||Hazard Ratio (HR)|0.53|||||2-Sided|95.0|0.31|0.89|||||HR = Nivolumab over Docetaxel; PD-L1 expression >= 5%|PD-L1 expression >= 5%|
1654249|NCT01642004|3044004|Superiority or Other (legacy)||Hazard Ratio (HR)|0.62||||0.0004|2-Sided|95.0|0.47|0.81|||Log Rank|Stratified by region (US/Canada vs Europe vs ROW) and prior treatment regimen (Paclitaxel vs Another Agent) as entered into the IVRS.|HR = Nivolumab over Docetaxel||
1654250|NCT01642004|3044009|Superiority or Other (legacy)||Hazard Ratio (HR)|0.59||||0.0002|2-Sided|96.85|0.43|0.81||Stratified by region (US/Canada, Rest Of World (ROW), Europe) and prior treatment regimen (Paclitaxel, Another agent) as entered in the Interactive Voice Response System (IVRS).|Log Rank||Stratified Cox proportional hazard model. HR = Nivolumab over Docetaxel||
1654251|NCT01642004|3044010|Superiority or Other (legacy)||Odds Ratio (OR)|2.64||||0.0083|2-Sided|95.0|1.27|5.49|||Cochran-Mantel-Haenszel|Stratified by region (US/Canada vs Europe vs ROW) and prior treatment regimen (Paclitaxel vs Another Agent) as entered into the IVRS.|OR = Nivolumab over Docetaxel||
1654252|NCT01642004|3044011|Superiority or Other (legacy)||Hazard Ratio (HR)|0.62||||0.0004|2-Sided|95.0|0.47|0.81||Stratified by region (US/Canada, Rest Of World (ROW), Europe) and prior treatment regimen (Paclitaxel, Another agent) as entered in the Interactive Voice Response System (IVRS).|Log Rank||Hazard Ratio (HR) = Nivolumab over Docetaxel||
1654253|NCT01641939|3044057|Superiority or Other||Hazard Ratio (HR)|1.13||||0.308|2-Sided|95.0|0.89|1.43|||Log Rank|||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy|
1654254|NCT01641939|3044059|Superiority or Other||Hazard Ratio (HR)|0.47|||||2-Sided|95.0|0.23|0.96||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Trastuzumab Emtansine 3.6 mg|
1654255|NCT01641939|3044059|Superiority or Other||Hazard Ratio (HR)|2.01|||||2-Sided|95.0|0.82|4.92||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.|
1654256|NCT01641939|3044059|Superiority or Other||Hazard Ratio (HR)|0.81|||||2-Sided|95.0|0.32|2.03||||||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% CI for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.|
1654257|NCT01641939|3044060|Superiority or Other||Hazard Ratio (HR)|1.15||||0.8589|2-Sided|95.0|0.87|1.6||One sided p-value with correction for interim treatment selection due to adaptive seamless phase design.|Log Rank|Log-Rank test, inverse normal combination test.||The unstratified Cox proportional hazards model was used to estimate the hazard ratio. The 95% Confidence Interval (CI) for median was computed using the method of Brookmeyer and Crowley. Reference group: Standard Taxane Therapy.|
1654258|NCT01641926|3044061|Superiority or Other||Adjusted Treatment Difference|0.9|||||2-Sided|95.0|-7.4|9.2||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.|
1654259|NCT01641926|3044062|Superiority or Other||Adjusted Treatment Difference|10.1|||||2-Sided|95.0|-7.2|27.1||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.|
1654260|NCT01641926|3044062|Superiority or Other||Adjusted Treatment Difference|2.1|||||2-Sided|95.0|-9.5|13.6||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.|
1654261|NCT01641926|3044063|Superiority or Other||Adjusted Treatment Difference|2.6|||||2-Sided|95.0|-7.2|12.3||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.|
1654403|NCT01639001|3044472|Superiority or Other||Kappa|0.847|||||2-Sided|95.0|0.8065|0.8875|||||Kappa coefficient is a statistic which measures inter-rater agreement for qualitative (categorical) items.||
1654262|NCT01641926|3044064|Superiority or Other||Adjusted Treatment Difference|-3.0|||||2-Sided|95.0|-20.2|14.3||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (HBV genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.|
1654263|NCT01641926|3044065|Superiority or Other||Adjusted Treatment Difference|1.6|||||2-Sided|95.0|-8.4|11.6||||||The treatment difference in the rates (PEG-Intron arm minus PEGASYS™ arm) and its 95% confidence interval adjusted for the baseline stratification factor (hepatitis B Virus [HBV] genotype) was computed using the method of Miettinen and Nurminen weighted by stratum sample size.|
1654264|NCT01641861|3044068|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1654265|NCT01641861|3044069|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1654266|NCT01641861|3044071|Superiority or Other||Odds Ratio (OR)|3.5|||||2-Sided|95.0|0.9|12.8|||||||
1654267|NCT01641861|3044072|Superiority or Other||Odds Ratio (OR)|1.0|||||2-Sided|95.0|0.1|7.3|||||||
1654268|NCT01641822|3044075|Superiority or Other||Mean Difference (Final Values)|3.06||||0.21|2-Sided|95.0|-1.71|7.82||The p-value is from an MMRM analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Mixed Models Analysis|||Difference in change in CFQ-R RSS|
1654269|NCT01641822|3044076|Superiority or Other||Risk Ratio (RR)|0.642||||0.14|2-Sided|95.0|0.355|1.164|||Negative binomial regression|||Comparison of hospitalization rate|
1654270|NCT01641822|3044077|Superiority or Other||Hazard Ratio (HR)|0.89||||0.71|2-Sided|95.0|0.5|1.59|||Log Rank|||Comparison of time to exacerbation|
1654271|NCT01641822|3044078|Superiority or Other|||||||0.67|||||||Fisher Exact|||Comparison of percentages|
1654272|NCT01641822|3044079|Superiority or Other||Mean Difference (Final Values)|1.33||||0.16|2-Sided|95.0|-0.55|3.2||The p-value is from an MMRM analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Mixed Models Analysis|||Difference in change in FEV1 % predicted|
1654273|NCT01641822|3044080|Superiority or Other||Risk Ratio (RR)|0.743||||0.25|2-Sided|95.0|0.446|1.238|||Negative binomial regression|||Ratio between rates|
1654274|NCT01641692|3044141|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.423|2-Sided|95.0|-2.4|1.0|||Mixed Models Analysis||||
1654275|NCT01641692|3044141|Superiority or Other||Mean Difference (Final Values)|0.0||||0.97|2-Sided|95.0|-1.8|1.7|||Mixed Models Analysis||||
1654276|NCT01641692|3044141|Superiority or Other||Mean Difference (Final Values)|1.5||||0.084|2-Sided|95.0|-0.2|3.2|||Mixed Models Analysis||||
1654277|NCT01641692|3044141|Superiority or Other||Mean Difference (Final Values)|0.6||||0.476|2-Sided|95.0|-1.1|2.3|||Mixed Models Analysis||||
1654278|NCT01641692|3044141|Superiority or Other||Mean Difference (Final Values)|0.6||||0.503|2-Sided|95.0|-1.1|2.2|||Mixed Models Analysis||||
1654279|NCT01641692|3044141|Superiority or Other||Mean Difference (Final Values)|1.5||||0.072|2-Sided|95.0|-0.1|3.2|||Mixed Models Analysis||||
1654280|NCT01641692|3044141|Superiority or Other||Mean Difference (Final Values)|0.3||||0.752|2-Sided|95.0|-1.4|2.0|||Mixed Models Analysis||||
1654281|NCT01641692|3044142|Superiority or Other||Mean Difference (Final Values)|1.5||||0.054|2-Sided|95.0|0.0|3.0|||Mixed Models Analysis||||
1654282|NCT01641692|3044142|Superiority or Other||Mean Difference (Final Values)|2.7|||<|0.001|2-Sided|95.0|1.2|4.3|||Mixed Models Analysis||||
1654283|NCT01641692|3044142|Superiority or Other||Mean Difference (Final Values)|2.2|||<|0.005|2-Sided|95.0|0.7|3.7|||Mixed Models Analysis||||
1654284|NCT01641692|3044142|Superiority or Other||Mean Difference (Final Values)|2.4|||<|0.002|2-Sided|95.0|0.9|3.9|||Mixed Models Analysis||||
1654285|NCT01641692|3044142|Superiority or Other||Mean Difference (Final Values)|2.0|||<|0.01|2-Sided|95.0|0.5|3.5|||Mixed Models Analysis||||
1654286|NCT01641692|3044142|Superiority or Other||Mean Difference (Final Values)|1.3|||<|0.077|2-Sided|95.0|-0.1|2.8|||Mixed Models Analysis||||
1654287|NCT01641692|3044142|Superiority or Other||Mean Difference (Final Values)|1.7|||<|0.03|2-Sided|95.0|0.2|3.2|||Mixed Models Analysis||||
1654288|NCT01641692|3044143|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.399|2-Sided|95.0|-2.7|1.1|||Mixed Models Analysis||||
1654289|NCT01641692|3044143|Superiority or Other||Mean Difference (Final Values)|0.7||||0.456|2-Sided|95.0|-1.2|2.7|||Mixed Models Analysis||||
1654290|NCT01641692|3044143|Superiority or Other||Mean Difference (Final Values)|0.4||||0.683|2-Sided|95.0|-1.5|2.3|||Mixed Models Analysis||||
1654291|NCT01641692|3044143|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.814|2-Sided|95.0|-2.1|1.7|||Mixed Models Analysis||||
1654292|NCT01641692|3044143|Superiority or Other||Mean Difference (Final Values)|1.5||||0.121|2-Sided|95.0|-0.4|3.3|||Mixed Models Analysis||||
1654293|NCT01641692|3044143|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.553|2-Sided|95.0|-2.4|1.3|||Mixed Models Analysis||||
1654294|NCT01641692|3044143|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.84|2-Sided|95.0|-2.1|1.7|||Mixed Models Analysis||||
1654295|NCT01641692|3044146|Superiority or Other||Mean Difference (Final Values)|0.051||||0.101|2-Sided|95.0|-0.01|0.113|||Mixed Models Analysis||||
1654296|NCT01641692|3044146|Superiority or Other||Mean Difference (Final Values)|0.057||||0.076|2-Sided|95.0|-0.006|0.119|||Mixed Models Analysis||||
1654297|NCT01641692|3044146|Superiority or Other||Mean Difference (Final Values)|0.011||||0.722|2-Sided|95.0|-0.05|0.073|||Mixed Models Analysis||||
1654298|NCT01641692|3044146|Superiority or Other||Mean Difference (Final Values)|0.088||||0.005|2-Sided|95.0|0.026|0.149|||Mixed Models Analysis||||
1654299|NCT01641692|3044146|Superiority or Other||Mean Difference (Final Values)|0.034||||0.272|2-Sided|95.0|-0.027|0.095|||Mixed Models Analysis||||
1654300|NCT01641692|3044146|Superiority or Other||Mean Difference (Final Values)|0.03||||0.331|2-Sided|95.0|-0.03|0.09|||Mixed Models Analysis||||
1654301|NCT01641692|3044146|Superiority or Other||Mean Difference (Final Values)|0.066||||0.036|2-Sided|95.0|0.004|0.127|||Mixed Models Analysis||||
1654304|NCT01641653|3044150|Superiority or Other|||||||0.87|||||||Wilcoxon (Mann-Whitney)|||This is a pilot study no power calculation was performed. The Wilcoxon rank-sum test was used to assess differences in max intraop glucose between placebo and midazolam groups.|
1654305|NCT01641640|3044156|Superiority or Other||||||<|0.001|||||||Binomial exact test|||Superiority would be demonstrated if the SVR12 rate was higher than the 60% null SVR rate based on historical control data.|
1654306|NCT01641380|3044161|Superiority or Other||[Proportion of Eligible Patients Enrolle|0.948|||||2-Sided||||||||||
1654307|NCT01641380|3044164|Superiority or Other||Difference of proportions|0.417||||0.5187|2-Sided|95.0|-13.3307|24.8818|||Chi-squared||Intervention 34/50; Control : 28/50|On time for 1st follow-up visit|
1654308|NCT01641380|3044164|Superiority or Other||Slope|-0.75|||<|0.05|2-Sided|95.0|-1.4|0.06|||Regression, Linear|||We also evaluated the difference between the number of days after the scheduled appointment patients returned.|
1654309|NCT01641237|3044225|Superiority or Other||Adjusted Mean Difference|0.99|||<|0.0001|2-Sided|95.0|0.75|1.23||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.|
1654310|NCT01641237|3044225|Superiority or Other||Adjusted Mean Difference|1.04|||<|0.0001|2-Sided|95.0|0.8|1.28||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.|
1654311|NCT01641237|3044225|Superiority or Other||Adjusted Mean Difference|0.05|||<|0.668|2-Sided|95.0|-0.19|0.29||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.|
1654312|NCT01641237|3044225|Superiority or Other||Adjusted Mean Difference|0.62|||<|0.0001|2-Sided|95.0|0.38|0.86||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.|
1654313|NCT01641237|3044225|Superiority or Other||Adjusted Mean Difference|1.6|||<|0.0001|2-Sided|95.0|1.36|1.85||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.|
1654314|NCT01641237|3044225|Superiority or Other||Adjusted Mean Difference|1.66|||<|0.0001|2-Sided|95.0|1.42|1.9||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.|
1654315|NCT01641237|3044225|Superiority or Other||||||<|0.0008|||||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for quadratic dose-response relationship was performed for EFU as a function of fluoride concentration.|
1654316|NCT01641237|3044225|Superiority or Other||||||<|0.0001|||||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for EFU as a function of fluoride concentration.|
1654317|NCT01641237|3044226|Superiority or Other||Adjusted Mean Difference|10.65||||0.0038|2-Sided|95.0|3.48|17.81||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.|
1654318|NCT01641237|3044226|Superiority or Other||Adjusted Mean Difference|11.57||||0.0017|2-Sided|95.0|4.4|18.74||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.|
1654319|NCT01641237|3044226|Superiority or Other||Adjusted Mean Difference|0.92||||0.8|2-Sided|95.0|-6.25|8.1||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.|
1654320|NCT01641237|3044226|Superiority or Other||Adjusted Mean Difference|20.81|||<|0.0001|2-Sided|95.0|13.6|28.02||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.|
1654321|NCT01641237|3044226|Superiority or Other||Adjusted Mean Difference|31.46|||<|0.0001|2-Sided|95.0|24.25|38.67||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.|
1654322|NCT01641237|3044226|Superiority or Other||Adjusted Mean Difference|32.38|||<|0.0001|2-Sided|95.0|25.18|39.59||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, while subject was random effect.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference between treatments, being compared.|
1654323|NCT01641237|3044226|Superiority or Other||||||<|0.0002|||||||ANOVA|||Test for quadratic dose-response relationship was performed for %RER as a function of fluoride concentration.|
1654324|NCT01641237|3044226|Superiority or Other||||||<|0.0001|||||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for %RER as a function of fluoride concentration.|
1654325|NCT01641237|3044227|Superiority or Other||Adjusted Mean Difference|4.25||||0.0112|2-Sided|95.0|0.98|7.53||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.|
1654326|NCT01641237|3044227|Superiority or Other||Adjusted Mean Difference|7.68|||<|0.0001|2-Sided|95.0|4.41|10.96||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.|
1654327|NCT01641237|3044227|Superiority or Other||Adjusted Mean Difference|9.86|||<|0.0001|2-Sided|95.0|6.58|13.13||No adjustment was required for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.|
1654328|NCT01641237|3044227|Superiority or Other||Adjusted Mean Difference|3.43|||<|0.0389|2-Sided|95.0|0.18|6.68||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.|
1654329|NCT01641237|3044227|Superiority or Other||Adjusted Mean Difference|5.6|||<|0.0009|2-Sided|95.0|2.35|8.86||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no dose-response relationship between %SMHR and fluoride concentration in the dentifrice.|
1654330|NCT01641237|3044227|Superiority or Other||Adjusted Mean Difference|2.17|||<|0.1898|2-Sided|95.0|-1.09|5.43||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with fixed factors for study period and treatment and the subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered treatments in comparison to be equal.|
1654331|NCT01641237|3044228|Superiority or Other|||||||0.3748|||||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for quadratic dose-response relationship was performed for %SMHR as a function of fluoride concentration.|
1654332|NCT01641237|3044228|Superiority or Other||||||<|0.0001|||||||ANOVA|Adjusted Mean and SE were calculated from ANOVA model with treatment and period as factors, and subject as a random factor.||Test for linear dose-response relationship was performed for %SMHR as a function of fluoride concentration.|
1654333|NCT01641198|3044229|Superiority||Mean Difference (Final Values)|-0.635|Standard Error of the Mean|0.2|<|0.05|2-Sided|95.0|-1.01|-0.26||Statistical analysis was based on the mixed linear model with the level of significance set at p<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI).|
1654334|NCT01641198|3044229|Superiority||Mean Difference (Final Values)|0.83|Standard Error of the Mean|0.2|<|0.05|2-Sided|95.0|0.45|1.22||Statistical analysis was based on the mixed linear model with the level of significance set at p<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)|
1654335|NCT01641198|3044229|Superiority||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.2|<|0.05|2-Sided|95.0|-0.19|0.59||Statistical analysis was based on the mixed linear model with the level of significance set at p<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)|
1654336|NCT01641198|3044230|Superiority||Mean Difference (Final Values)|-0.725|Standard Error of the Mean|0.135|<|0.05|2-Sided|95.0|-1.02|-0.43||Statistical analysis was based on the mixed linear model with the level of significance set at p<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI)|
1654337|NCT01641198|3044230|Superiority||Mean Difference (Final Values)|0.56|Standard Error of the Mean|0.13|<|0.05|2-Sided|95.0|0.26|0.85||Statistical analysis was based on the mixed linear model with the level of significance set at p<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)|
1654338|NCT01641198|3044230|Superiority||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.135|<|0.05|2-Sided|95.0|-0.47|0.13||Statistical analysis was based on the mixed linear model with the level of significance set at p<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)|
1654339|NCT01641198|3044231|Superiority||Mean Difference (Final Values)|-0.685|Standard Error of the Mean|0.115|<|0.05|2-Sided|95.0|-0.98|-0.39||Statistical analysis was based on the mixed linear model with the level of significance set at p<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between SW and SC estimated with the mixed linear model (mean±SE, 95% CI)|
1654340|NCT01641198|3044231|Superiority||Mean Difference (Final Values)|0.39|Standard Error of the Mean|0.12|<|0.05|2-Sided|95.0|0.09|0.69||Statistical analysis was based on the mixed linear model with the level of significance set at p<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SC estimated with the mixed linear model (mean±SE, 95% CI)|
1654341|NCT01641198|3044231|Superiority||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.115|<|0.05|2-Sided|95.0|-0.59|0.01||Statistical analysis was based on the mixed linear model with the level of significance set at p<0.05 and Bonferroni correction for pairwise comparisons|Mixed Models Analysis|Mixed linear model with effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect)||Mean bone change between B and SW estimated with the mixed linear model (mean±SE, 95% CI)|
1654342|NCT01641120|3044246|Superiority or Other|||||||0.005|||||||Wilcoxon Signed Ranks||||
1654343|NCT01641120|3044247|Superiority or Other|||||||0.035|||||||Wilcoxon Signed Ranks||||
1654344|NCT01641120|3044248|Superiority or Other|||||||0.193|||||||Wilcoxon Signed Ranks||||
1654345|NCT01641120|3044249|Superiority or Other||||||<|0.05|||||||Wilcoxon Signed Ranks||||
1654346|NCT01641081|3044251|Superiority or Other||Least squares mean difference|0.2174|Standard Error of the Mean|0.0146|<|0.0001|2-Sided|95.0|0.1887|0.2461|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate|||
1654347|NCT01641081|3044251|Superiority or Other||Least squares mean difference|0.2242|Standard Error of the Mean|0.0153|<|0.0001|2-Sided|95.0|0.1941|0.2544|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate|||
1654348|NCT01641081|3044251|Superiority or Other||Least squares mean difference|0.2524|Standard Error of the Mean|0.0156|<|0.0001|2-Sided|95.0|0.2218|0.283|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate|||
1654349|NCT01641081|3044251|Superiority or Other||Least squares mean difference|0.2644|Standard Error of the Mean|0.0148|<|0.0001|2-Sided|95.0|0.2353|0.2934|||Mixed Models Analysis|Treatment and period as fixed effects, and baseline FEV1 values at each period as a covariate|||
1654350|NCT01640925|3044296|Non-Inferiority or Equivalence|The number of patients needed to achieve 80% power was estimated at 171 using Cox proportional hazards regression (hazard ratio reduction of 0.66; 0.15 probability of infection with control) using a two-sided 5% significance.|Cox Proportional Hazard|0.555||||0.049|2-Sided|95.0|0.309|0.998|||Regression, Cox||Hypothesis: Compared to soap and water daily bathing, 2% chlorhexidine gluconate bathing on ICU admission and every 48 hours during surgical ICU care will decrease the risk of acquiring four hospital-acquired infections in surgical ICU patients.||
1654351|NCT01640873|3044297|Other|Day 16|Geometric Mean Ratio|1.1||||0.217|2-Sided|95.0|0.89|1.37|||ANOVA|Placebo-corrected (MK-8655 / placebo)|||
1654352|NCT01640873|3044297|Other|Day 3|Geometric mean Ratio|1.2||||0.065|2-Sided|95.0|0.98|1.47|||ANOVA|Placebo-corrected (MK-8655 / placebo)|||
1654353|NCT01640873|3044297|Other|Day 1|Geometric Mean Ratio|1.22||||0.06|2-Sided|95.0|0.99|1.55|||ANOVA|Placebo-corrected (MK-8655 / placebo)|||
1654354|NCT01640873|3044298|Other||Geometric Mean Ratio|1.05||||0.2714|2-Sided|90.0|0.92|1.19||The posterior probability that the reduction in 24h-WMG is ≥ 20 mg/dL is < 0.01, and hence, the 24h- WMG hypothesis was not met.|Constrained longitudinal data analysis||||
1654355|NCT01640873|3044300|Other||Least Squares Mean Difference|-8.5||||0.356|2-Sided|90.0|-47.4|30.4||The posterior probability that the reduction in FPG is ≥ 20 mg/dL is 0.06, and hence, the FPG hypothesis was not met.|Constrained longitudinal data analysis||||
1654356|NCT01640834|3044303|Superiority or Other||Mean Difference (Net)|-5187.0||||0.0046|2-Sided|95.0|-8371.0|-2004.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).|
1654357|NCT01640834|3044303|Superiority or Other||Mean Difference (Net)|-4423.0||||0.0278|2-Sided|95.0|-8256.0|-590.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).|
1654358|NCT01640834|3044304|Superiority or Other||Mean Difference (Net)|-59.0||||0.0048|2-Sided|95.0|-96.0|-23.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).|
1654359|NCT01640834|3044304|Superiority or Other||Mean Difference (Net)|-46.0||||0.0187|2-Sided|95.0|-82.0|-9.0|||t-test, 2 sided|||Statistical analysis of the effect of LY2409021 treatment on peak glucose concentration after an intramuscular injection of glucagon (1 milligram).|
1654360|NCT01640834|3044309|Superiority or Other||Mean Difference (Net)|-19.6||||0.0192|2-Sided|95.0|-35.0|-4.3|||t-test, 1 sided|||Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group using a 1 sample t-test.|
1654404|NCT01639001|3044472|Superiority or Other||Overall percent agreement|0.934|||||2-Sided|95.0|0.914|0.949|||||95% CI for agreement rate is calculated by the Wilson (Score) Confidence Limit method with alpha=0.05||
1654361|NCT01640834|3044309|Superiority or Other||Mean Difference (Net)|-17.0||||0.046|2-Sided|95.0|-33.7|-0.4|||t-test, 1 sided|||Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.|
1654362|NCT01640834|3044310|Superiority or Other||Mean Difference (Net)|-6.89||||0.0826|2-Sided|95.0|-14.95|1.16|||t-test, 1 sided|||The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group.|
1654363|NCT01640834|3044310|Superiority or Other||Mean Difference (Net)|-5.84||||0.0542|2-Sided|95.0|-11.82|0.14|||t-test, 1 sided|||The mean change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 100-mg LY2409021 dose group using a 1 sample t-test.|
1654364|NCT01640379|3044322|Superiority||Odds Ratio (OR)|1.0||||0.351|2-Sided|95.0|0.86|1.06|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for women in the TECH-N arm relative to women in the control arm.|H0: Women in the TECHN arm practiced temporary sexual abstinence for two weeks after their diagnosis more often than those in the control arm.|
1654365|NCT01640379|3044322|Superiority||Odds Ratio (OR)|0.6||||0.153|2-Sided|95.0|0.33|1.19|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for partners of TECH-N recipients versus partners of women in control arm.|H0: Partners of women receiving the TECH-N intervention were treated more often than the partners of women in the control arm.|
1654366|NCT01640379|3044322|Superiority||Odds Ratio (OR)|0.9||||0.867|2-Sided|95.0|0.36|2.34|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for the chances of partner notification among TECH N recipients, relative to those in control arm.|H0: Women in TECHN arm notified their partners about their diagnoses more often than women in the control arm.|
1654367|NCT01640379|3044322|Superiority||Odds Ratio (OR)|0.6||||0.084|2-Sided|95.0|0.36|1.05|||Regression, Logistic|Adjusted for age, debut age, number of lifetime partners, pregnancy history, baseline STI status (any versus none), and insurance.|Odds ratio is for intervention arm relative to control.|H0: Women in TECHN arm reported complete adherence to medication regimen (yes or no) with same frequency as women in control arm.|
1654368|NCT01640379|3044322|Superiority||Odds Ratio (OR)|92.2|||<|0.001|2-Sided|95.0|37.0|230.1|||Chi-squared|Adjusted for age, debut age, number of lifetime partners, baseline STI status (any vs none), insurance, and if woman had prior pregnancy.|Odds ratio is interpretable as the expected chance of having a 72 follow-up for intervention women compared to women in the control arm, given similar age, debut age, number of lifetime partners, baseline STI status, insurance, and pregnancy history.|H0: Women in TECHN arm had 72 hour visit with same frequency as women in control arm.|
1654369|NCT01640379|3044323|Superiority||Odds Ratio (OR)|0.59||||0.043|2-Sided|95.0|0.39|0.98||Judged by type one error limit alpha = 0.05.|generalized estimating equations||The odds ratio is for the difference in rate of change over time between arms, so is the difference in the odds increment for those receiving TECH N intervention versus the control group.|"We used generalized estimating equations to test for a difference in the trend of chlamydia or gonorrhea (CT/GC) rates over the study period.~The null hypothesis is that rates of CT/GC for women in the intervention arm were changing over the study period similarly to CT/GC rates in the control arm."|
1654370|NCT01640379|3044323|Superiority||Odds Ratio (OR)|0.4||||0.07|2-Sided|95.0|0.15|1.09||Judged by type one error limit alpha = 0.05.|t-test, 2 sided||The odds ratio is for the difference in chlamydia or gonorrhea (CT/GC) rates between arms at ninety days after intervention.|A comparison of Chlamydia or Gonorrhea positivity at 90 days post intervention.|
1654371|NCT01640197|3044359|Superiority or Other||||||>|0.05|||||||ANOVA||||
1654372|NCT01640197|3044360|Superiority or Other||||||>|0.05|||||||ANOVA||||
1654373|NCT01640197|3044361|Superiority or Other||||||>|0.05|||||||ANOVA||||
1654374|NCT01640197|3044362|Superiority or Other||||||>|0.05|||||||ANOVA||||
1654375|NCT01640197|3044363|Superiority or Other||||||>|0.05|||||||ANOVA||||
1654376|NCT01640197|3044364|Superiority or Other||||||>|0.05|||||||ANOVA||||
1654377|NCT01640197|3044365|Superiority or Other||||||>|0.05|||||||ANOVA||||
1654378|NCT01639872|3044380|Superiority||difference in treatment means|-0.32|Standard Error of the Mean|0.28||0.25|2-Sided||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.||
1654379|NCT01639872|3044381|Superiority||difference in treatment means|0.014|Standard Error of the Mean|1.62||0.99|2-Sided||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.||
1654380|NCT01639703|3044398|Other||Odds Ratio (OR)|1.41||||0.1753|2-Sided|95.0|0.86|2.31|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and >50%) considering an increase of 10 units for Permeability Surface|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.|
1654381|NCT01639703|3044399|Other||Odds Ratio (OR)|0.9||||0.7127|2-Sided|95.0|0.53|1.54|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and >50%) considering an increase of 10 units for Permeability Surface|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.|
1654655|NCT01634152|3044981|Superiority or Other||Mean Difference (Net)|-0.013|Standard Error of the Mean|0.053||0.7991|2-Sided|95.0|-0.117|0.09|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654382|NCT01639703|3044400|Other||Odds Ratio (OR)|1.08||||0.4195|2-Sided|95.0|0.9|1.29|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and >50%) considering an increase of 10 units for Blood Flow|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.|
1654383|NCT01639703|3044401|Other||Odds Ratio (OR)|0.9||||0.3487|2-Sided|95.0|0.71|1.13|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and >50%) considering an increase of 10 units for Blood Flow|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.|
1654384|NCT01639703|3044402|Other||Odds Ratio (OR)|1.13||||0.5354|2-Sided|95.0|0.77|1.66|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and >50%) considering an increase of 5 units for Blood Volume|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.|
1654385|NCT01639703|3044403|Other||Odds Ratio (OR)|0.76||||0.2476|2-Sided|95.0|0.47|1.21|||Regression, Logistic||Odds-ratio is the risk to move from one immunochemistry category to the below one (among 0%, 1-10%, 10-50% and >50%) considering an increase of 5 units for Blood Volume|Multinomial logistic regression analyses were performed with each off-site CT perfusion parameters as explicative variables taken alone and each off-site immunohistochemistry categorized parameters as dependent variables.|
1654386|NCT01639560|3044411|Superiority or Other||Odds Ratio (OR)|5.0||||0.009|2-Sided|95.0|1.5|16.5|||Regression, Logistic||||
1654387|NCT01639560|3044412|Superiority or Other||Odds Ratio (OR)|2.5||||0.047|2-Sided|95.0|1.0|6.3|||Regression, Logistic||||
1654388|NCT01639560|3044413|Superiority or Other||Odds Ratio (OR)|7.33||||0.001|2-Sided|95.0|2.2|24.0|||Regression, Logistic||||
1654389|NCT01639560|3044414|Superiority or Other||Odds Ratio (OR)|6.7|||<|0.001|2-Sided|95.0|2.5|18.1|||Regression, Logistic||||
1654390|NCT01639495|3044416|Superiority or Other||Percentage of subjects|97.2|||||2-Sided|95.0|95.6|98.2|||||The 2-sided 95% confidence intervals are exact binomial||
1654391|NCT01639495|3044417|Superiority or Other||Percentage of subjects with primary AEs|17.4|||||2-Sided|95.0|11.6|24.6|||||The 2-sided 95% confidence interval is exact binomial||
1654392|NCT01639495|3044419|Superiority or Other||Percentage of subjects|60.6|||||2-Sided|95.0|51.9|68.8|||||The 2-sided 95% confidence intervals are based on exact binomial||
1654393|NCT01639469|3044420|Superiority||Incidence Rate Ratio|0.39|||<|0.001|2-Sided|95.0|0.22|0.68|||Negative Binomial Regression|||Testing to see if there is a significant difference in fall rates over 12months between the two groups.|
1654394|NCT01639443|3044421|Superiority or Other|||||||0.11|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of cost per day. We are powered to detect a 0.5 SD difference in clinic capacity (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."|
1654395|NCT01639443|3044422|Superiority or Other|||||||0.024|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of length of workday. We are powered to detect approximately 0.5 SD difference in workday length in hours (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."|
1654396|NCT01639443|3044423|Superiority or Other|||||||0.05|||||||t-test, 2 sided|||We calculated this measure on the patient level, but were hampered by a large sampling ratio (more than 50:1). Our null hypothesis is that the number of polyps detected will not differ between groups. We are powered to detect a 0.25 SD difference in polyp count per patient (Type I error rate = 5%; Power = 80%).|
1654397|NCT01639443|3044424|Superiority or Other|||||||0.49||||||We would have only expected 2 patients to be bumped in the Experimental Group, and observed 0.|Fisher Exact|||We did not explicitly power this study to detect differences in the number of service bumps, but we can compare them using Fisher's Exact Test|
1654398|NCT01639443|3044425|Superiority or Other|||||||0.29|||||||t-test, 2 sided|||We calculated this measure on the patient level. Our null hypothesis is that the lag time between scheduling and appointment, measured in days, will not differ between groups. We are powered to detect a 0.3 SD difference in lag time (Type I error rate = 5%; Power = 84%), accounting for the large sampling ratio (approximately 14:1).|
1654399|NCT01639443|3044426|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||"We counted days containing at least one Fast-tracked participant as a Fast-tracked day for the sake of analysis at the clinic level. Our null hypothesis is that these days will not differ in terms of percentage of clinic capacity filled. We are powered to detect a 0.5 Standard Deviation (SD) difference in clinic capacity (Type I error rate = 5%; Power = 81%), with a equal ratio of Experimental and Control days."|
1654400|NCT01639222|3044433|Superiority or Other||Calcium-Vitamin D/Reference (%)|156.74|||||2-Sided|95.0|121.66|201.93|||||Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D / reference treatment) are provided on the original scale as a ratio * 100%.||
1654401|NCT01639222|3044434|Superiority or Other||Calcium-Vitamin D/Reference (%)|71.77|||||2-Sided|95.0|68.83|74.84|||||Point estimate and 95% CI for the treatment difference ratio (Calcium-Vitamin D /reference treatment) are provided on the original scale as a ratio * 100%.||
1654402|NCT01639222|3044435|Superiority or Other||Calcium-Vitamin D/Reference (%)|179.72|||||2-Sided|95.0|157.16|205.52|||||Point estimates and 95% CIs for the treatment difference ratio (Calcium-Vitamin D/reference treatment) are provided on the original scale as a ratio * 100%.|The primary parameters were analysed in a mixed effects general linear model of the logtransformed values, including treatment as a fixed effect and subject as a random effect. The objective of the trial was met if the treatment contrast was statistically significantly different from 0 in the appropriate direction in a 2-sided test on a 5% significance level for both parameters. The 5% significance level for both primary parameters was not adjusted for multiple testing.|
1654405|NCT01639001|3044474|Superiority or Other||Mean Difference (Net)|0.0425||||0.032|2-Sided|95.0|0.0|0.08|||Mixed Models Analysis|||From a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EQ-5D Index score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654406|NCT01639001|3044475|Superiority or Other||Mean Difference (Net)|3.9136||||0.0123|2-Sided|95.0|0.85|6.98|||Mixed Models Analysis|||From a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EQ-5D VAS subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654407|NCT01639001|3044476|Superiority or Other||Mean Difference (Net)|-2.398||||0.0296|2-Sided|95.0|-4.56|-0.24|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 sore mouth. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654408|NCT01639001|3044476|Superiority or Other||Mean Difference (Net)|-1.6732||||0.2848|2-Sided|95.0|-4.74|1.39|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 peripheral neuropathy. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654409|NCT01639001|3044476|Superiority or Other||Mean Difference (Net)|-4.5901||||0.0075|2-Sided|95.0|-7.95|-1.23|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in other parts. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654410|NCT01639001|3044476|Superiority or Other||Mean Difference (Net)|-4.2237||||0.0185|2-Sided|95.0|-7.74|-0.71|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in chest. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654411|NCT01639001|3044476|Superiority or Other||Mean Difference (Net)|-4.2363||||0.0265|2-Sided|95.0|-7.98|-0.49|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 pain in arm or shoulder. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654412|NCT01639001|3044476|Superiority or Other||Mean Difference (Net)|-1.2504||||0.1284|2-Sided|95.0|-2.86|0.36|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 haemoptysis. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654413|NCT01639001|3044476|Superiority or Other||Mean Difference (Net)|-8.6471|||<|0.0001|2-Sided|95.0|-11.85|-5.44|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 dyspnoea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654414|NCT01639001|3044476|Superiority or Other||Mean Difference (Net)|-0.5181|||<|0.7082|2-Sided|95.0|-3.23|2.2|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 dysphagia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654415|NCT01639001|3044476|Superiority or Other||Mean Difference (Net)|-6.9957|||<|0.0004|2-Sided|95.0|-10.85|-3.14|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 coughing. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654416|NCT01639001|3044476|Superiority or Other||Mean Difference (Net)|-4.8547|||<|0.0039|2-Sided|95.0|-8.15|-1.56|||Mixed Models Analysis|||Analysis presented for QLQ-LC13 alopecia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654417|NCT01639001|3044477|Superiority or Other||Mean Difference (Net)|-8.4349|||<|0.0001|2-Sided|95.0|-11.42|-5.45|||Mixed Models Analysis|||Analysis presented for QLQ-C30 pain. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654418|NCT01639001|3044477|Superiority or Other||Mean Difference (Net)|-2.519|||<|0.0902|2-Sided|95.0|-5.43|0.4|||Mixed Models Analysis|||Analysis presented for QLQ-C30 nausea and vomiting. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654419|NCT01639001|3044477|Superiority or Other||Mean Difference (Net)|-6.7756|||<|0.0004|2-Sided|95.0|-10.49|-3.06|||Mixed Models Analysis|||Analysis presented for QLQ-C30 insomnia. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654438|NCT01639001|3044488|Superiority or Other||Treatment Difference|41.869|||<|0.0001|2-Sided|95.0|30.34|53.398||If the PFS endpoint was significant, ORR was to be considered significant if 2-sided p-value from Pearson chi-square test was <= 0.04992.|2-sided pearson chi-square test||Treatment difference in ORR (%)|The confidence interval for the treatment difference was based on normal distribution.|
1654420|NCT01639001|3044477|Superiority or Other||Mean Difference (Net)|-3.6165|||<|0.2099|2-Sided|95.0|-9.27|2.04|||Mixed Models Analysis|||Analysis presented for QLQ-C30 financial difficulties. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654421|NCT01639001|3044477|Superiority or Other||Mean Difference (Net)|-6.4915|||<|0.0001|2-Sided|95.0|-9.82|-3.17|||Mixed Models Analysis|||Analysis presented for QLQ-C30 fatigue. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654422|NCT01639001|3044477|Superiority or Other||Mean Difference (Net)|-7.7449|||<|0.0001|2-Sided|95.0|-11.3|-4.19|||Mixed Models Analysis|||Analysis presented for QLQ-C30 dysponea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654423|NCT01639001|3044477|Superiority or Other||Mean Difference (Net)|15.8085|||<|0.0001|2-Sided|95.0|12.94|18.68|||Mixed Models Analysis|||Analysis presented for QLQ-C30 diarrhea. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654424|NCT01639001|3044477|Superiority or Other||Mean Difference (Net)|4.5026|||<|0.0263|2-Sided|95.0|0.53|8.47|||Mixed Models Analysis|||Analysis presented for QLQ-C30 constipation. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654425|NCT01639001|3044477|Superiority or Other||Mean Difference (Net)|-6.0432|||<|0.0016|2-Sided|95.0|-9.79|-2.3|||Mixed Models Analysis|||Analysis presented for QLQ-C30 appetite loss. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654426|NCT01639001|3044478|Superiority or Other||Mean Difference (Net)|5.594||||0.014|2-Sided|95.0|1.13|10.06|||Mixed Models Analysis|||Analysis presented for QLQ-C30 social functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654427|NCT01639001|3044478|Superiority or Other||Mean Difference (Net)|6.8109||||0.0003|2-Sided|95.0|3.15|10.47|||Mixed Models Analysis|||Analysis presented for QLQ-C30 role functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654428|NCT01639001|3044478|Superiority or Other||Mean Difference (Net)|6.7267|||<|0.0001|2-Sided|95.0|4.15|9.3|||Mixed Models Analysis|||Analysis presented for QLQ-C30 physical functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654429|NCT01639001|3044478|Superiority or Other||Mean Difference (Net)|1.652|||<|0.2427|2-Sided|95.0|-1.12|4.42|||Mixed Models Analysis|||Analysis presented for QLQ-C30 emotional functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654430|NCT01639001|3044478|Superiority or Other||Mean Difference (Net)|3.613|||<|0.014|2-Sided|95.0|0.73|6.49|||Mixed Models Analysis|||Analysis presented for QLQ-C30 cognitive functioning. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654431|NCT01639001|3044478|Superiority or Other||Mean Difference (Net)|7.451|||<|0.0001|2-Sided|95.0|3.79|11.11|||Mixed Models Analysis|||Analysis presented for QLQ-C30 Global QoL. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, visit day and baseline EORTC QLQ-C30 subscale score (intercept and visit day are included as random effects). P-values and confidence intervals are not adjusted for multiplicity.|
1654432|NCT01639001|3044479|Superiority or Other||Hazard Ratio (HR)|0.432|||<|0.0001|2-Sided|95.0|0.307|0.61||2‑sided Hochberg adjusted p‑values|2 sided unstratified log rank||Based on the Cox Proportional hazards model.||
1654433|NCT01639001|3044480|Superiority or Other||Hazard Ratio (HR)|0.277|||<|0.0001|2-Sided|95.0|0.186|0.412|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.||
1654434|NCT01639001|3044481|Superiority or Other||Hazard Ratio (HR)|0.669||||0.127|2-Sided|95.0|0.335|1.338|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.||
1654435|NCT01639001|3044482|Superiority or Other||Hazard Ratio (HR)|0.348|||<|0.0001|2-Sided|95.0|0.246|0.493|||1 sided unstratified log-rank||Based on the Cox Proportional hazards model.||
1654436|NCT01639001|3044486|Superiority or Other||Treatment difference|8.906||||0.1204|2-Sided|95.0|-2.275|20.086|||2-sided pearson chi-square test||Treatment Difference in DCR Rate (%)|The confidence interval for the treatment difference was based on normal distribution.|
1654437|NCT01639001|3044487|Superiority or Other||Hazard Ratio (HR)|0.897||||0.3274|2-Sided|95.0|0.556|1.445||If the PFS and ORR endpoints were significant, OS was to be considered significant if 1-sided, log-rank test stratified for ECOG, ethnicity and metastases was <= 0.02496.|1 sided stratified log-rank||Based on the Cox Proportional hazards model stratified by ECOG PS, ethnicity, and brain metastases. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of crizotinib.||
1654439|NCT01639001|3044489|Superiority or Other||Hazard Ratio (HR)|0.402|||<|0.0001|2-Sided|95.0|0.286|0.565||The study was to be considered positive if the 1‐sided log‐rank test for PFS, stratified for baseline stratification factors (ECOG PS, ethnicity, and brain metastases) was significant at the 0.02496level.|1 sided stratified log-rank||Based on the Cox Proportional hazards model stratified by ECOG PS, ethnicity, and brain metastases. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of crizotinib.|The study was designed to test the null hypothesis H0: λ=1.0 versus the alternative hypothesis HA: λ < 1.0, where λ is the hazard ratio (HR; Crizotinib/Chemotherapy). Evaluation of 160 PFS events in the 2 arms using a 1‐sided log‐rank test at the 0.025 level of significance was required to detect a HR of 0.64 with 80% power.|
1654440|NCT01638546|3044517|Other||||||||||||||||||The study will be performed as a double-blind, placebo controlled, randomized Phase II in patients with relapsed sensitive or refractory SCLC. Eligible patients will be randomized 1:1 to one of two treatment arms: ABT-888 and temozolomide as the investigational arm, versus placebo and temozolomide as the control arm. The randomization will be stratified by center and by type or relapse (sensitive vs. refractory). The primary objective is to compare the two treatment regimens with respect to efficacy, expressed as Progression Free Survival (PFS) at 4 months post-randomization. PFS will be calculated as proportion of patients alive and without evidence of disease at 4 months after randomization.
1654441|NCT01638429|3044539|Superiority or Other|||||||0.075|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment|
1654442|NCT01638429|3044539|Superiority or Other|||||||0.33|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment|
1654443|NCT01638429|3044540|Superiority or Other|||||||0.059|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment|
1654444|NCT01638429|3044540|Superiority or Other|||||||0.22|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment|
1654445|NCT01638429|3044541|Superiority or Other|||||||0.27|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment|
1654446|NCT01638429|3044541|Superiority or Other|||||||0.29|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment|
1654447|NCT01638429|3044542|Superiority or Other|||||||0.25|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment|
1654448|NCT01638429|3044542|Superiority or Other|||||||0.13|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment|
1654449|NCT01638429|3044543|Superiority or Other|||||||0.44|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment|
1654450|NCT01638429|3044543|Superiority or Other|||||||0.43|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment|
1654451|NCT01638429|3044544|Superiority or Other|||||||0.14|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment|
1654452|NCT01638429|3044544|Superiority or Other|||||||0.018|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment|
1654453|NCT01638429|3044545|Superiority or Other|||||||0.45|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment|
1654454|NCT01638429|3044545|Superiority or Other|||||||0.61|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment|
1654455|NCT01638429|3044546|Superiority or Other|||||||0.85|||||||t-test, 2 sided|||Values compared in total study population pre- and post-treatment|
1654456|NCT01638429|3044546|Superiority or Other|||||||0.97|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment|
1654457|NCT01638429|3044547|Superiority or Other|||||||0.01|||||||t-test, 2 sided|||P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatment|
1654458|NCT01638429|3044548|Superiority or Other|||||||0.028|||||||t-test, 2 sided|||P-value is comparing change in methane eradiacators before and after treatment to change in methane non-eradiacators before and after treatment|
1654459|NCT01638429|3044550|Superiority or Other|||||||0.16|||||||t-test, 2 sided|||Values compared in methane eradicators only pre- and post-treatment|
1654460|NCT01638000|3044562|Superiority or Other||Odds Ratio (OR)|1.21||||0.069|2-Sided|95.0|0.99|1.5||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visitI|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron|
1654461|NCT01638000|3044562|Superiority or Other||Odds Ratio (OR)|1.23||||0.058|2-Sided|95.0|0.99|1.53||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron|
1654462|NCT01638000|3044563|Superiority or Other||Odds Ratio (OR)|1.18||||0.15|2-Sided|95.0|0.94|1.49||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron|
1654463|NCT01638000|3044563|Superiority or Other||Odds Ratio (OR)|1.24||||0.082|2-Sided|95.0|0.97|1.57||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron|
1654464|NCT01638000|3044564|Superiority or Other||Odds Ratio (OR)|1.14||||0.66|2-Sided|95.0|0.64|2.04||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.|Participants from Canada were therefore excluded from this analysis due to low participant numbers.|Final visit (6 point improvement) Odds Rato vs. Mirabegron|
1654902|NCT01632345|3045165|Superiority or Other||Difference in % response|2.7||||||95.0|-6.1|11.7|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654465|NCT01638000|3044564|Superiority or Other||Odds Ratio (OR)|1.05||||0.75|2-Sided|95.0|0.77|1.44||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥5 point improvement) Odds Rato vs. Mirabegron|
1654466|NCT01638000|3044564|Superiority or Other||Odds Ratio (OR)|1.17||||0.15|2-Sided|95.0|0.95|1.46||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥4 point improvement) Odds Rato vs. Mirabegron|
1654467|NCT01638000|3044564|Superiority or Other||Odds Ratio (OR)|1.24||||0.054|2-Sided|95.0|1.0|1.53||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥3 point improvement) Odds Rato vs. Mirabegron|
1654468|NCT01638000|3044564|Superiority or Other||Odds Ratio (OR)|1.27||||0.063|2-Sided|95.0|0.99|1.62||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥2 point improvement) Odds Rato vs. Mirabegron|
1654469|NCT01638000|3044564|Superiority or Other||Odds Ratio (OR)|1.44||||0.016|2-Sided|95.0|1.07|1.93||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit (≥1 point improvement) Odds Rato vs. Mirabegron|
1654470|NCT01638000|3044565|Superiority or Other||Odds Ratio (OR)|1.14||||0.66|2-Sided|95.0|0.64|2.04||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.|Participants from Canada were therefore excluded from this analysis due to low participant numbers.|Week 12 (6 point improvement) Odds Rato vs. Mirabegron|
1654471|NCT01638000|3044565|Superiority or Other||Odds Ratio (OR)|1.02||||0.89|2-Sided|95.0|0.75|1.4||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥5 point improvement) Odds Rato vs. Mirabegron|
1654472|NCT01638000|3044565|Superiority or Other||Odds Ratio (OR)|1.18||||0.14|2-Sided|95.0|0.95|1.47||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥4 point improvement) Odds Rato vs. Mirabegron|
1654473|NCT01638000|3044565|Superiority or Other||Odds Ratio (OR)|1.25||||0.051|2-Sided|95.0|1.0|1.55||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥3 point improvement) Odds Rato vs. Mirabegron|
1654474|NCT01638000|3044565|Superiority or Other||Odds Ratio (OR)|1.27||||0.065|2-Sided|95.0|0.99|1.65||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥2 point improvement) Odds Rato vs. Mirabegron|
1654475|NCT01638000|3044565|Superiority or Other||Odds Ratio (OR)|1.51||||0.009|2-Sided|95.0|1.11|2.06||Iif p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 (≥1 point improvement) Odds Rato vs. Mirabegron|
1654476|NCT01638000|3044566|Superiority or Other||Odds Ratio (OR)|1.26||||0.045|2-Sided|95.0|1.01|1.57||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron|
1654477|NCT01638000|3044566|Superiority or Other||Odds Ratio (OR)|1.28||||0.037|2-Sided|95.0|1.02|1.62||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron|
1654478|NCT01638000|3044567|Superiority or Other||Odds Ratio (OR)|1.37||||0.011|2-Sided|95.0|1.07|1.75||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron|
1654479|NCT01638000|3044567|Superiority or Other||Odds Ratio (OR)|1.4||||0.01|2-Sided|95.0|1.08|1.81||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron|
1654507|NCT01638000|3044595|Superiority or Other||Odds Ratio (OR)|1.05||||0.67|2-Sided|95.0|0.85|1.28||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds ratio vs. Mirabegron|
1654480|NCT01638000|3044568|Superiority or Other||Least squares mean difference|0.15|Standard Error of the Mean|0.071||0.034|2-Sided|95.0|0.01|0.29||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654481|NCT01638000|3044568|Superiority or Other||Least squares mean diffrence|0.16|Standard Error of the Mean|0.07||0.027|2-Sided|95.0|0.02|0.29||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654482|NCT01638000|3044569|Superiority or Other||Least squares mean difference|0.42|Standard Error of the Mean|0.141||0.003|2-Sided|95.0|0.14|0.7||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654483|NCT01638000|3044569|Superiority or Other||Least squares mean difference|0.43|Standard Error of the Mean|0.141||0.002|2-Sided|95.0|0.15|0.7||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654484|NCT01638000|3044570|Superiority or Other||Least squares mean difference|-0.14|Standard Error of the Mean|0.059||0.021|2-Sided|95.0|-0.25|-0.02||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654485|NCT01638000|3044570|Superiority or Other||Least squares mean difference|-0.15|Standard Error of the Mean|0.06||0.015|2-Sided|95.0|-0.26|-0.03||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron.Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654486|NCT01638000|3044570|Superiority or Other||Least squares mean difference|-0.16|Standard Error of the Mean|0.054||0.003|2-Sided|95.0|-0.27|-0.06||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654487|NCT01638000|3044570|Superiority or Other||Least squares mean difference|-0.09|Standard Error of the Mean|0.05||0.07|2-Sided|95.0|-0.19|0.01||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654488|NCT01638000|3044571|Superiority or Other||Least squares mean difference|1.41|Standard Error of the Mean|0.873||0.11|2-Sided|95.0|-0.3|3.12||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654489|NCT01638000|3044571|Superiority or Other||Least squares mean difference|1.55|Standard Error of the Mean|0.866||0.074|2-Sided|95.0|-0.15|3.25||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654490|NCT01638000|3044571|Superiority or Other||Least squares mean difference|1.55|Standard Error of the Mean|0.805||0.055|2-Sided|95.0|-0.03|3.13||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariates.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654491|NCT01638000|3044571|Superiority or Other||Least squares mean difference|1.14|Standard Error of the Mean|0.77||0.14|2-Sided|95.0|-0.37|2.65||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654656|NCT01634152|3044981|Superiority or Other||Mean Difference (Net)|-0.036|Standard Error of the Mean|0.052||0.4864|2-Sided|95.0|-0.139|0.066|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1655090|NCT01625091|3046227|Superiority|||||||0.36|||||||Wilcoxon (Mann-Whitney)||||
1654492|NCT01638000|3044572|Superiority or Other||Least squares mean difference|-1.87|Standard Error of the Mean|0.924||0.043|2-Sided|95.0|-3.68|-0.06||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654493|NCT01638000|3044572|Superiority or Other||Least squares mean difference|-2.1|Standard Error of the Mean|0.917||0.022|2-Sided|95.0|-3.9|-0.3||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654494|NCT01638000|3044572|Superiority or Other||Least squares mean difference|-1.8|Standard Error of the Mean|0.849||0.034|2-Sided|95.0|-3.46|-0.13||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654495|NCT01638000|3044572|Superiority or Other||Least squares mean difference|-1.69|Standard Error of the Mean|0.817||0.039|2-Sided|95.0|-3.29|-0.08||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as covariate.||Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654496|NCT01638000|3044593|Superiority or Other||Odds Ratio (OR)|1.02||||0.9|2-Sided|95.0|0.73|1.42||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron|
1654497|NCT01638000|3044593|Superiority or Other||Odds Ratio (OR)|0.98||||0.92|2-Sided|95.0|0.69|1.39||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron|
1654498|NCT01638000|3044593|Superiority or Other||Odds Ratio (OR)|0.91||||0.57|2-Sided|95.0|0.65|1.26||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds Ratio vs. Mirabegron|
1654499|NCT01638000|3044593|Superiority or Other||Odds Ratio (OR)|1.22||||0.2|2-Sided|95.0|0.9|1.67||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds Ratio vs. Mirabegron|
1654500|NCT01638000|3044594|Superiority or Other||Odds Ratio (OR)|1.25||||0.29|2-Sided|95.0|0.82|1.9||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final visit Odds Ratio vs. Mirabegron|
1654501|NCT01638000|3044594|Superiority or Other||Odds Ratio (OR)|1.27||||0.29|2-Sided|95.0|0.81|2.0||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds Ratio vs. Mirabegron|
1654502|NCT01638000|3044594|Superiority or Other||Odds Ratio (OR)|1.07||||0.74|2-Sided|95.0|0.71|1.63||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds Ratio vs. Mirabegron|
1654503|NCT01638000|3044594|Superiority or Other||Odds Ratio (OR)|1.06||||0.74|2-Sided|95.0|0.76|1.48||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 4 Odds Ratio vs. Mirabegron|
1654504|NCT01638000|3044595|Superiority or Other||Odds Ratio (OR)|1.18||||0.093|2-Sided|95.0|0.97|1.43||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Final Visit Odds ratio vs. Mirabegron|
1654505|NCT01638000|3044595|Superiority or Other||Odds Ratio (OR)|1.18||||0.11|2-Sided|95.0|0.97|1.44||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 12 Odds ratio vs. Mirabegron|
1654506|NCT01638000|3044595|Superiority or Other||Odds Ratio (OR)|1.25||||0.026|2-Sided|95.0|1.03|1.53||If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.|Regression, Logistic|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.||Week 8 Odds ratio vs. Mirabegron|
1654836|NCT01633853|3045065|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||The levels of blood 25(OH)Vitamin D were compared between the 24th month and the baseline in group 1,25(OH)2 Vitamin D3.|
1654508|NCT01638000|3044596|Superiority or Other||Least squares mean difference|0.01|Standard Error of the Mean|0.046||0.81|2-Sided|95.0|-0.08|0.1||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654509|NCT01638000|3044596|Superiority or Other||Least squares mean difference|0.03|Standard Error of the Mean|0.044||0.5|2-Sided|95.0|-0.06|0.12||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654510|NCT01638000|3044596|Superiority or Other||Least squares mean difference|0.09|Standard Error of the Mean|0.047||0.058|2-Sided|95.0|0.0|0.18||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654511|NCT01638000|3044597|Superiority or Other||Rate ratio|1.03||||0.44|2-Sided|95.0|0.96|1.1||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron|
1654512|NCT01638000|3044597|Superiority or Other||Rate ratio|1.02||||0.52|2-Sided|95.0|0.95|1.1||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 12 Rate Ratio vs. Mirabegron|
1654513|NCT01638000|3044597|Superiority or Other||Rate ratio|1.04||||0.21|2-Sided|95.0|0.98|1.11||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron|
1654514|NCT01638000|3044597|Superiority or Other||Rate ratio|1.05||||0.068|2-Sided|95.0|1.0|1.11||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron|
1654515|NCT01638000|3044598|Superiority or Other||Least squares mean difference|-0.06|Standard Error of the Mean|0.111||0.59|2-Sided|95.0|-0.28|0.16||if p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654516|NCT01638000|3044598|Superiority or Other||Least squares mean difference|-0.05|Standard Error of the Mean|0.099||0.63|2-Sided|95.0|-0.24|0.15||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654517|NCT01638000|3044598|Superiority or Other||Least squares mean difference|-0.02|Standard Error of the Mean|0.115||0.84|2-Sided|95.0|-0.25|0.2||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654518|NCT01638000|3044599|Superiority or Other||Rate ratio|1.08||||0.4|2-Sided|95.0|0.9|1.31||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron|
1654519|NCT01638000|3044599|Superiority or Other||Rate ratio|1.12||||0.25|2-Sided|95.0|0.92|1.37||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 12 Rate Ratio vs. Mirabegron|
1654520|NCT01638000|3044599|Superiority or Other||Rate ratio|1.17||||0.073|2-Sided|95.0|0.99|1.39||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron|
1654521|NCT01638000|3044599|Superiority or Other||Rate ratio|1.03||||0.67|2-Sided|95.0|0.89|1.2||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron|
1654536|NCT01638000|3044603|Superiority or Other||Rate ratio|0.92||||0.44|2-Sided|95.0|0.74|1.14||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron|
1655012|NCT01628042|3045632|Superiority or Other||Geometric least-squares mean ratio|1.96|||||2-Sided|90.0|1.23|3.13|||||||
1654522|NCT01638000|3044600|Superiority or Other||Least squares mean difference|0.01|Standard Error of the Mean|0.031||0.74|2-Sided|95.0|-0.05|0.07||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Final visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654523|NCT01638000|3044600|Superiority or Other||Least squares mean difference|0.0|Standard Error of the Mean|0.032||0.99|2-Sided|95.0|-0.06|0.06||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654524|NCT01638000|3044600|Superiority or Other||Least squares mean difference|-0.02|Standard Error of the Mean|0.027||0.47|2-Sided|95.0|-0.07|0.03||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654525|NCT01638000|3044600|Superiority or Other||Least squares mean difference|0.0|Standard Error of the Mean|0.023||0.99|2-Sided|95.0|-0.05|0.05||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654526|NCT01638000|3044601|Superiority or Other||Least squares mean difference|-0.23|Standard Error of the Mean|0.163||0.16|2-Sided|95.0|-0.55|0.09||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Final Visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654527|NCT01638000|3044601|Superiority or Other||Least squares mean difference|-0.32|Standard Error of the Mean|0.164||0.053|2-Sided|95.0|-0.64|0.0|||ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654528|NCT01638000|3044601|Superiority or Other||Least squares mean difference|-0.35|Standard Error of the Mean|0.157||0.027|2-Sided|95.0|-0.66|-0.04||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654529|NCT01638000|3044601|Superiority or Other||Least squares mean difference|-0.13|Standard Error of the Mean|0.16||0.43|2-Sided|95.0|-0.44|0.19||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654530|NCT01638000|3044602|Superiority or Other||Least squares mean difference|-0.11|Standard Error of the Mean|0.066||0.66|2-Sided|95.0|-0.24|0.02||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654531|NCT01638000|3044602|Superiority or Other||Least squares mean difference|-0.17|Standard Error of the Mean|0.07||0.17|2-Sided|95.0|-0.31|-0.03||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654532|NCT01638000|3044602|Superiority or Other||Least squares mean difference|-0.02|Standard Error of the Mean|0.081||0.66|2-Sided|95.0|-0.18|0.14||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From stratified rank ANCOVA analysis.||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654533|NCT01638000|3044603|Superiority or Other||Rate ratio|0.97||||0.85|2-Sided|95.0|0.71|1.33||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Final Visit Rate Ratio vs. Mirabegron|
1654534|NCT01638000|3044603|Superiority or Other||Rate ratio|1.05||||0.78|2-Sided|95.0|0.76|1.45||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 12 Rate Ratio vs. Mirabegron|
1654535|NCT01638000|3044603|Superiority or Other||Rate ratio|0.79||||0.11|2-Sided|95.0|0.6|1.06||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 8 Rate Ratio vs. Mirabegron|
1654537|NCT01638000|3044604|Superiority or Other||Least squares mean difference|-0.25|Standard Error of the Mean|0.163||0.47|2-Sided|95.0|-0.57|0.07||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.|
1654538|NCT01638000|3044604|Superiority or Other||Least squares mean difference|-0.22|Standard Error of the Mean|0.13||0.12|2-Sided|95.0|-0.48|0.03||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From the stratified rank ANCOVA analysis.||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654539|NCT01638000|3044604|Superiority or Other||Least squares mean difference|-0.08|Standard Error of the Mean|0.089||0.36|2-Sided|95.0|-0.25|0.1||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|From stratified rank ANCOVA analysis.||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654540|NCT01638000|3044605|Superiority or Other||Rate ratio|0.92||||0.57|2-Sided|95.0|0.68|1.24||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Final Visit Rate Ratio vs. Mirabegron|
1654541|NCT01638000|3044605|Superiority or Other||Rate ratio|0.97||||0.83|2-Sided|95.0|0.71|1.32||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates||Week 12 Rate Ratio vs. Mirabegron.|
1654542|NCT01638000|3044605|Superiority or Other||Rate ratio|0.84||||0.21|2-Sided|95.0|0.64|1.1||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 8 Rate Ratio vs. Mirabegron.|
1654543|NCT01638000|3044605|Superiority or Other||Rate ratio|0.9||||0.33|2-Sided|95.0|0.73|1.11||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|Poisson regression|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.||Week 4 Rate Ratio vs. Mirabegron.|
1654544|NCT01638000|3044606|Superiority or Other||least squares mean difference|-0.2|Standard Error of the Mean|0.125||0.12|2-Sided|95.0|-0.44|0.05||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654545|NCT01638000|3044606|Superiority or Other||least squares mean difference|-0.23|Standard Error of the Mean|0.119||0.053|2-Sided|95.0|-0.47|0.0||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654546|NCT01638000|3044606|Superiority or Other||least squares mean difference|0.04|Standard Error of the Mean|0.117||0.71|2-Sided|95.0|-0.19|0.27||If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.|
1654547|NCT01638000|3044607|Superiority or Other||Odds Ratio (OR)|1.53||||0.03|2-Sided|95.0|1.04|2.25||If P <0.05, this indicates superiority in favor of the treatment group with the smallest percentage of participants with at least 1 TEAE of dry mouth, constipation or blurred vision during the double-blind period at the final visit.|Regression, Logistic|Included treatment group, sex, age group (< 65, ≥ 65), number of prior antimuscarinics (1, ≥ 2) and geographic region as factors.||Difference vs Mirabegron. Differences of the percentages were calculated by subtracting the percentage of mirabegron 50 mg group from the percentage of solifenacin 5 mg group.|
1654548|NCT01638000|3044608|Non-Inferiority or Equivalence|Non-inferiority was concluded if the lower limit of the 95% CI for difference of adjusted change from baseline between solifenacin 5 mg and mirabegron 50 mg was > -0.20. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg. Overall power calculation was 80% for a 1-sided test and significance level of 0.025.|least squares mean difference|-0.18|Standard Error of the Mean|0.124||0.15|2-Sided|95.0|-0.42|0.06||If p<0.05, this indicated superiority in favor of the treatment group with the largest improvement at specified visit.|ANCOVA|Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate||The non-inferiority of mirabegron vs. solifencacin on the change from baseline to final visit in the mean number of micturitions per 24 hours.|
1654549|NCT01637935|3044616|Superiority or Other||Hazard Ratio (HR)|1.07||||||95.0|0.79|1.44||||||Cumulative dose >40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.|
1654624|NCT01636258|3044806|Superiority or Other||Mean Difference (Net)|0.3|Standard Deviation|2.1||0.72|2-Sided|95.0|-1.4|2.0||P-value less than 0.05 considered statistically significant a priori. No multiple comparison adjustment made.|t-test, 2 sided|||No sample size calculation performed since it was a pilot study. Null hypothesis was no difference between groups.|
1654550|NCT01637935|3044616|Superiority or Other||Hazard Ratio (HR)|1.1||||||95.0|0.85|1.42||||||Cumulative dose 14001–40000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.|
1654551|NCT01637935|3044616|Superiority or Other||Hazard Ratio (HR)|0.9||||||95.0|0.69|1.16||||||Cumulative dose 1–14000 mg. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.|
1654552|NCT01637935|3044617|Superiority or Other||Hazard Ratio (HR)|1.16||||||95.0|0.87|1.54||||||Duration of therapy >4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.|
1654553|NCT01637935|3044617|Superiority or Other||Hazard Ratio (HR)|1.03||||||95.0|0.8|1.33||||||Duration of therapy 1.5-4 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.|
1654554|NCT01637935|3044617|Superiority or Other||Hazard Ratio (HR)|0.88||||||95.0|0.68|1.16||||||Duration of therapy <1.5 years. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.|
1654555|NCT01637935|3044618|Superiority or Other||Hazard Ratio (HR)|1.2||||||95.0|0.83|1.75||||||Time since starting pioglitazone >8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.|
1654556|NCT01637935|3044618|Superiority or Other||Hazard Ratio (HR)|1.21||||||95.0|0.93|1.59||||||Time since starting pioglitazone 4.5-8 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.|
1654557|NCT01637935|3044618|Superiority or Other||Hazard Ratio (HR)|0.89||||||95.0|0.71|1.12||||||Time since starting pioglitazone <4.5 years vs unexposed group. Fully adjusted including all potential confounders in statistical model from 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder, renal insufficiency, HbA1c and interaction with new diagnosis of diabetes, duration of diabetes, year of cohort entry and proteinuria.|
1654558|NCT01637935|3044619|Superiority or Other||Cox Proportional Hazard|1.06||||||95.0|0.89|1.26||||||Fully adjusted adding the proteinuria testing variable.|
1654559|NCT01637935|3044619|Superiority or Other||Cox Proportional Hazard|1.1||||||95.0|0.92|1.31||||||Fully adjusted refers to inclusion of all potential confounders in the statistical model from the 5-year interim report plus year of cohort entry: age, sex, race/ethnicity, other diabetes medications, smoking, other bladder conditions, median household income, congestive heart failure, cancer other than bladder cancer, renal insufficiency, HbA1c and the interaction with new diagnosis of diabetes, duration of diabetes, and year of cohort entry.|
1654560|NCT01637922|3044621|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|94.33|Standard Deviation|27.6||0.0738|2-Sided|90.0|78.017|114.054||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1|
1654561|NCT01637922|3044622|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|98.94|Standard Deviation|19.6||0.0107|2-Sided|90.0|85.81|114.076||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NALOXONE(BUP) + Faldaprevir(FDV) on Day 9 vs. NALOXONE(BUP) alone on Day 1|
1654562|NCT01637922|3044623|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|112.03|Standard Deviation|52.5||0.3152|2-Sided|90.0|74.85|167.67||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1|
1654563|NCT01637922|3044624|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|132.86|Standard Deviation|51.1||0.6188|2-Sided|90.0|93.32|189.16||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1|
1654564|NCT01637922|3044625|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|138.0|Standard Deviation|50.7||0.6889|2-Sided|90.0|97.2|195.92||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|NORBUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. NORBUPRENORPHINE(BUP) alone on Day 1|
1654565|NCT01637922|3044626|Superiority or Other||Pearson Correlation Coefficient|0.92231|||||||||||||Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.|Pearson correlation of trough concentrations of naloxone and SOWS|
1654566|NCT01637922|3044626|Superiority or Other||Pearson Correlation Coefficient|0.04052|||||2-Sided|95.0|-0.218159|0.293233||||||Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and SOWS|
1654567|NCT01637922|3044626|Superiority or Other||Pearson Correlation Coefficient|-0.05787|||||2-Sided|95.0|-0.24392|0.132819||||||Pearson correlation of trough concentrations of norbuprenorphine and SOWS|
1654568|NCT01637922|3044626|Superiority or Other||Pearson Correlation Coefficient|0.02352|||||2-Sided|95.0|-0.253932|0.29696||||||Pearson correlation of change from baseline for trough concentrations of Buprenorphine and SOWS|
1654569|NCT01637922|3044626|Superiority or Other||Pearson Correlation Coefficient|0.0126|||||2-Sided|95.0|-0.17016|0.194417||||||Pearson correlation of trough concentrations of Buprenorphine and SOWS|
1654570|NCT01637922|3044626|Superiority or Other||Pearson Correlation Coefficient|-0.16815|||||2-Sided|95.0|-0.34787|0.025107||||||Pearson correlation of change from baseline for trough concentrations of S-methadone and SOWS|
1654571|NCT01637922|3044626|Superiority or Other||Pearson Correlation Coefficient|0.11175|||||2-Sided|95.0|-0.069336|0.284848||||||Pearson correlation of trough concentrations of S-methadone and SOWS|
1654572|NCT01637922|3044626|Superiority or Other||Pearson Correlation Coefficient|-0.39865|||||2-Sided|95.0|-0.547072|-0.222288||||||Pearson correlation of change from baseline for trough concentrations of R-methadone and SOWS|
1654573|NCT01637922|3044626|Superiority or Other||Pearson Correlation Coefficient|0.04783|||||2-Sided|95.0|-0.13275|0.224946||||||Pearson correlation of trough concentrations of R-methadone and SOWS|
1654574|NCT01637922|3044627|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|108.36|Standard Deviation|38.1||0.1915|2-Sided|90.0|81.611|143.883||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1|
1654575|NCT01637922|3044628|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|92.43|Standard Deviation|33.7||0.142|2-Sided|90.0|73.48|116.27||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1|
1654576|NCT01637922|3044629|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|108.71|Standard Deviation|36.1||0.1642|2-Sided|90.0|85.14|138.8||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|BUPRENORPHINE(BUP) + Faldaprevir(FDV) on Day 9 vs. BUPRENORPHINE(BUP) alone on Day 1|
1654577|NCT01637922|3044630|Superiority or Other||Pearson Correlation Coefficient|0.36105|||||||||||||Confidence interval is not provided due to sparse data. There was only 1 patient for this analysis.|Pearson correlation of trough concentrations of naloxone and OOWS|
1654578|NCT01637922|3044630|Superiority or Other||Pearson Correlation Coefficient|-0.09727|||||2-Sided|95.0|-0.344024|0.163687||||||Pearson correlation of change from baseline for trough concentrations of norbuprenorphine and OOWS|
1654579|NCT01637922|3044630|Superiority or Other||Pearson Correlation Coefficient|-0.05431|||||2-Sided|95.0|-0.240578|0.136305||||||Pearson correlation of trough concentrations of norbuprenorphine and OOWS|
1654580|NCT01637922|3044630|Superiority or Other||Pearson Correlation Coefficient|-0.14703|||||2-Sided|95.0|-0.404929|0.135425||||||Pearson correlation of change from baseline for trough concentrations of Buprenorphine and OOWS|
1654581|NCT01637922|3044630|Superiority or Other||Pearson Correlation Coefficient|-0.03364|||||2-Sided|95.0|-0.214505|0.149733||||||Pearson correlation of trough concentrations of Buprenorphine and OOWS|
1654582|NCT01637922|3044630|Superiority or Other||Pearson Correlation Coefficient|0.0026|||||2-Sided|95.0|-0.189172|0.194156||||||Pearson correlation of change from baseline for trough concentrations of S-methadone and OOWS|
1654583|NCT01637922|3044630|Superiority or Other||Pearson Correlation Coefficient|-0.03198|||||2-Sided|95.0|-0.209893|0.148238||||||Pearson correlation of trough concentrations of S-methadone and OOWS|
1654584|NCT01637922|3044630|Superiority or Other||Pearson Correlation Coefficient|-0.10188|||||2-Sided|95.0|-0.287471|0.092062||||||Pearson correlation of change from baseline for trough concentrations of R-methadone and OOWS|
1654585|NCT01637922|3044630|Superiority or Other||Pearson Correlation Coefficient|-0.01098|||||2-Sided|95.0|-0.189801|0.16864||||||Pearson correlation of trough concentrations of R-methadone and OOWS|
1654586|NCT01637922|3044631|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.52|Standard Deviation|17.7||0.0488|2-Sided|90.0|99.577|124.888||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1|
1654587|NCT01637922|3044632|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.46|Standard Deviation|16.3||0.0367|2-Sided|90.0|100.42|123.715||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1|
1654588|NCT01637922|3044633|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|117.65|Standard Deviation|15.0||0.1424|2-Sided|90.0|106.89|129.5||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|S-Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. S-Methadone(MTD) alone on Day 1|
1654589|NCT01637922|3044634|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|111.79|Standard Deviation|18.7||0.0603|2-Sided|90.0|99.243|125.922||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1|
1654590|NCT01637922|3044635|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|114.08|Standard Deviation|13.2||0.0391|2-Sided|90.0|104.812|124.164||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1|
1654591|NCT01637922|3044636|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio (%)|118.12|Standard Deviation|15.4||0.1638|2-Sided|90.0|107.06|130.32||p-value for ratio outside interval 80% to 125%|ANOVA|Log transformed endpoints were analyzed using an ANOVA model, including treatment as a fixed effect and subject as a random effect.|The standard deviation is actually the intra-individual geometric coefficient of variation|Methadone(MTD) + Faldaprevir(FDV) on Day 9 vs. Methadone(MTD) alone on Day 1|
1654592|NCT01637584|3044639|Superiority or Other|||||||0.01||||||Threshold for significance: <.05|Full Factorial ANOVAs and Paired T-tests|||Within-state increase in rCMRglc: Ke=7,049: x,y,z= 66, -18, 26. Right BA 1, 3, 15, 21, 22, 23, 41, 42|
1654593|NCT01637584|3044639|Superiority or Other|||||||0.03||||||Threshold for significance: <.05|Full Factorial ANOVAs and Paired T-tests|||Within-state decrease in rCMRglc: Ke=6,150: x,y,z= -30, -30, 2. Left BA 40, insula, hippocampus, caudate, and putamen;|
1654594|NCT01637584|3044639|Superiority or Other|||||||1||||||Threshold for significance: <.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness < REM: No cluster size, coordinates, or brain regions to report|
1654595|NCT01637584|3044639|Superiority or Other|||||||0.701||||||Threshold for significance: <.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness > (Rapid Eye Movement (REM): No cluster size, coordinates, or brain regions to report|
1654596|NCT01637584|3044639|Superiority or Other|||||||0.039||||||Threshold for significance: <.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness < NREM: Ke=7,013: x,y,z= 26, 22, -40. Right BA 4, 10-14, 21, 25, 32, 38, 45;|
1654597|NCT01637584|3044639|Superiority or Other||||||<|0.001||||||Threshold for significance: <.05|Full Factorial ANOVAs and Paired T-tests|||Wakefulness > Non-Rapid Eye Movement (NREM): Mean K-cluster voxels (Ke)=15,586: x,y,z= -36, -74, 0. Left Brodmann's Area (BA) 3, 6, 7, 10, 17, 19, 20,21,23, 38|
1654598|NCT01637077|3044669|Superiority|||||||0.4|||||||Kruskal-Wallis|||Motor neuropathy|
1654599|NCT01637077|3044669|Superiority|||||||0.86|||||||Kruskal-Wallis|||Autonomic neuropathy|
1654600|NCT01637077|3044669|Superiority|||||||0.46|||||||Kruskal-Wallis|||Sensory neuropathy|
1654601|NCT01637077|3044670|Superiority|||||||0.16|||||||Chi-squared||||
1654602|NCT01637077|3044671|Superiority|||||||0.78|||||||Chi-squared||||
1654603|NCT01637077|3044672|Superiority|||||||0.12|||||||Kruskal-Wallis||||
1654604|NCT01637077|3044673|Superiority|||||||0.03|||||||Chi-squared||||
1654605|NCT01637077|3044674|Superiority|||||||0.84|||||||Chi-squared||||
1654606|NCT01637077|3044675|Superiority|||||||0.87|||||||Chi-squared||||
1654607|NCT01637077|3044677|Superiority|||||||0.07|||||||Kruskal-Wallis|||Least pain over the past 24 hours|
1654608|NCT01637077|3044677|Superiority|||||||0.22|||||||Kruskal-Wallis|||Average pain over the past 24 hours|
1654609|NCT01637077|3044677|Superiority|||||||0.62|||||||Kruskal-Wallis|||Worst pain over the past 24 hours|
1654610|NCT01637077|3044678|Superiority|||||||0.48|||||||Kruskal-Wallis||||
1654611|NCT01637077|3044679|Superiority|||||||0.56|||||||Kruskal-Wallis||||
1654612|NCT01636947|3044690|Superiority or Other|||||||0.458|||||||Pearson's chi-square test|||Overall Stage p-value|
1654613|NCT01636947|3044691|Superiority or Other|||||||0.191|||||||Pearson's chi-square test||||
1654614|NCT01636778|3044749|Superiority or Other||Percentage|88.0|||||2-Sided|95.0|74.0|96.0|||||||
1654615|NCT01636713|3044755|Superiority or Other||Least squares mean difference|0.216|||<|0.001|2-Sided|95.0|0.175|0.257|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference= UMEC/VI 125/25 µg minus Placebo.||
1654616|NCT01636713|3044755|Superiority or Other||Least squares mean difference|0.151|||<|0.001|2-Sided|95.0|0.11|0.191|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Placebo.||
1654617|NCT01636687|3044776|Superiority or Other||Risk Difference (RD)|83.4|||<|0.0001|2-Sided|95.0|70.7|91.7|||Fisher Exact|||Response criterion: PASI 75|
1654618|NCT01636687|3044776|Superiority or Other||Risk Difference (RD)|68.4|||<|0.0001|2-Sided|95.0|53.1|79.8|||Fisher Exact|||Response criterion: PASI 75|
1654619|NCT01636687|3044776|Superiority or Other||Risk Difference (RD)|73.3|||<|0.0001|2-Sided|95.0|58.8|83.9|||Fisher Exact|||Response Criterion: IGA 0/1|
1654620|NCT01636687|3044776|Superiority or Other||Risk Difference (RD)|53.3|||<|0.0001|2-Sided|95.0|36.6|67.7|||Fisher Exact|||Response criterion: IGA 0/1|
1654621|NCT01636258|3044803|Superiority or Other|||||||0.53|||||||Wilcoxon (Mann-Whitney)||||
1654622|NCT01636258|3044804|Superiority or Other|||||||0.31|||||||Wilcoxon (Mann-Whitney)||||
1654623|NCT01636258|3044805|Superiority or Other|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||No sample study calculation performed since it was a pilot study. Null hypothesis was no difference between groups.|
1654625|NCT01635855|3044848|Superiority or Other||One-sided binomial|8.5|||<|0.025|2-Sided|95.0|3.5|13.6||Ho (null): Ps >= 22% versus Ha (alternate): Ps < 22% where Ps is the proportion of subjects with common severe adverse events in the post-approval study. Ho is rejected if upper limit of the 95% CI of Ps < 22% and the one-sided p-value <= 0.025.|One sided binomial distribution|The upper limit of the 95% two-sided CI for a proportion is equivalent to the 97.5% one-sided CI for that proportion for normal approximations.||The analysis was performed by comparing the proportion of subjects with severe common adverse events in the post-market study to that occurred in the pre-market studies. It was pre-specified in the protocol that the proportion of subjects with severe common adverse events in the pre-market studies was 22%.|
1654626|NCT01635218|3044872|Superiority or Other||Odds Ratio (OR)|0.27||||0.11|2-Sided|95.0|0.05|1.39|||Chi-squared||||
1654627|NCT01635218|3044872|Superiority or Other||Odds Ratio (OR)|0.26||||0.1||95.0|0.05|1.32|||Chi-squared||||
1654628|NCT01635218|3044873|Superiority or Other||Mean Difference (Final Values)|3.6|Standard Error of the Mean|2.37||0.424|2-Sided|95.0|-2.33|9.6||The ANOVA result (p<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA||||
1654629|NCT01635218|3044873|Superiority or Other||Mean Difference (Final Values)|8.6|Standard Error of the Mean|2.42||0.002|2-Sided|95.0|2.72|14.52||The ANOVA result (p<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA||||
1654630|NCT01635218|3044874|Superiority or Other||Odds Ratio (OR)|0.19|||<|0.05|2-Sided|95.0|0.06|0.56|||Chi-squared||||
1654631|NCT01635218|3044874|Superiority or Other||Odds Ratio (OR)|0.11|||<|0.05|2-Sided|95.0|0.03|0.34|||Chi-squared||||
1654632|NCT01635218|3044875|Superiority or Other||Mean Difference (Final Values)|1.28|Standard Error of the Mean|1.73||0.99|2-Sided|95.0|-2.93|5.5||The ANOVA result (p<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA||||
1654633|NCT01635218|3044875|Superiority or Other||Mean Difference (Final Values)|3.4|Standard Error of the Mean|1.71||0.14|2-Sided|95.0|-0.73|7.61||The statistical significant ANOVA result (p<0.05) suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA||||
1654634|NCT01635218|3044876|Superiority or Other||Mean Difference (Final Values)|3.2|Standard Error of the Mean|0.81|<|0.05|2-Sided|95.0|1.31|5.25||The ANOVA result (p<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA||||
1654635|NCT01635218|3044876|Superiority or Other||Mean Difference (Final Values)|5.0|Standard Error of the Mean|0.8|<|0.05|2-Sided|95.0|3.1|7.0||The ANOVA result (p<0.05)suggests rejecting the global null hypothesis.Bonferroni post-hoc test was used to determine which means differ among groups.|ANOVA||||
1654636|NCT01635101|3044882|Other||LS Mean Difference|1.4||||0.967|2-Sided|97.5|-75.9|78.7|||ANOVA|||LS Mean Difference|
1654637|NCT01635101|3044882|Other||LS Mean Difference|-11.8||||0.736|2-Sided|97.5|-91.0|67.3|||ANOVA|||Difference in Least Squares (LS) Means|
1654638|NCT01635062|3044883|Superiority or Other||Mean Difference (Final Values)|13.0||||0.8|2-Sided||||||ANOVA|||The hypothesis was that calcitriol therapy would lower urine protein, when sodium loaded, when compared to placebo.|
1654639|NCT01635062|3044884|Superiority or Other||Mean Difference (Final Values)|15.8||||0.89|2-Sided||||||ANOVA|||The hypothesis was that calcitriol therapy would raise renal plasma flow, when sodium loaded, when compared to placebo.|
1654640|NCT01635062|3044885|Superiority or Other||Median Difference (Final Values)|1.3||||0.69|2-Sided||||||ANOVA|||The hypothesis was that calcitriol therapy would lower plasma renin activity (PRA), when sodium restricted, when compared to placebo.|
1654641|NCT01634854|3044892|Superiority|||||||0.11|||||||Wilcoxon (Mann-Whitney)||||
1654642|NCT01634555|3044909|Superiority or Other||Ratio of Geo LS means|0.97|||||2-Sided|90.0|0.85|1.12|||||||
1654643|NCT01634555|3044909|Superiority or Other||Ratio of Geo LS means|1.04|||||2-Sided|90.0|0.97|1.12|||||||
1654644|NCT01634555|3044911|Superiority or Other||Ratio of Geo LS means|0.95|||||2-Sided|90.0|0.88|1.04|||||||
1654645|NCT01634555|3044911|Superiority or Other||Ratio of Geo LS means|0.93|||||2-Sided|90.0|0.83|1.05|||||||
1654646|NCT01634269|3044954|Superiority or Other (legacy)||Proportion of IF implanted subjects|87.5||||0.002|2-Sided|95.0|61.7|98.4|||Exact binomial||||
1654647|NCT01634152|3044977|Superiority or Other||Mean Difference (Net)|0.025|Standard Error of the Mean|0.041||0.5497|2-Sided|95.0|-0.056|0.105|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654648|NCT01634152|3044977|Superiority or Other||Mean Difference (Net)|-0.017|Standard Error of the Mean|0.041||0.6748|2-Sided|95.0|-0.097|0.063|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654649|NCT01634152|3044978|Superiority or Other||Mean Difference (Net)|-0.071|Standard Error of the Mean|0.06||0.236|2-Sided|95.0|-0.189|0.047|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654650|NCT01634152|3044978|Superiority or Other||Mean Difference (Net)|-0.015|Standard Error of the Mean|0.059||0.8055|2-Sided|95.0|-0.131|0.102|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654651|NCT01634152|3044979|Superiority or Other||Mean Difference (Net)|-0.083|Standard Error of the Mean|0.052||0.1108|2-Sided|95.0|-0.185|0.019|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654652|NCT01634152|3044979|Superiority or Other||Mean Difference (Net)|0.016|Standard Error of the Mean|0.051||0.7498|2-Sided|95.0|-0.084|0.117|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654653|NCT01634152|3044980|Superiority or Other||Mean Difference (Net)|-0.012|Standard Error of the Mean|0.051||0.8115|2-Sided|95.0|-0.112|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654654|NCT01634152|3044980|Superiority or Other||Mean Difference (Net)|0.007|Standard Error of the Mean|0.05||0.8884|2-Sided|95.0|-0.092|0.106|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654657|NCT01634152|3044982|Superiority or Other||Mean Difference (Net)|-0.015|Standard Error of the Mean|0.05||0.7708|2-Sided|95.0|-0.112|0.083|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654658|NCT01634152|3044982|Superiority or Other||Mean Difference (Net)|-0.006|Standard Error of the Mean|0.049||0.9043|2-Sided|95.0|-0.103|0.091|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654659|NCT01634152|3044983|Superiority or Other||Mean Difference (Net)|0.007|Standard Error of the Mean|0.043||0.873|2-Sided|95.0|-0.077|0.09|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654660|NCT01634152|3044983|Superiority or Other||Mean Difference (Net)|-0.001|Standard Error of the Mean|0.042||0.9869|2-Sided|95.0|-0.083|0.082|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654661|NCT01634152|3044984|Superiority or Other||Mean Difference (Net)|-0.061|Standard Error of the Mean|0.041||0.141|2-Sided|95.0|-0.142|0.02|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654662|NCT01634152|3044984|Superiority or Other||Mean Difference (Net)|-0.051|Standard Error of the Mean|0.041||0.2064|2-Sided|95.0|-0.131|0.028|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654663|NCT01634152|3044985|Superiority or Other||Mean Difference (Net)|-0.049|Standard Error of the Mean|0.039||0.2032|2-Sided|95.0|-0.125|0.027|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654664|NCT01634152|3044985|Superiority or Other||Mean Difference (Net)|-0.032|Standard Error of the Mean|0.038||0.4066|2-Sided|95.0|-0.107|0.043|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654665|NCT01634152|3044986|Superiority or Other||Mean Difference (Net)|-0.502|Standard Error of the Mean|1.042||0.6298|2-Sided|95.0|-2.545|1.541|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654666|NCT01634152|3044986|Superiority or Other||Mean Difference (Net)|-0.95|Standard Error of the Mean|1.025||0.3542|2-Sided|95.0|-2.959|1.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654667|NCT01634152|3044987|Superiority or Other||Mean Difference (Net)|-4.107|Standard Error of the Mean|4.867||0.399|2-Sided|95.0|-13.658|5.444|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654668|NCT01634152|3044987|Superiority or Other||Mean Difference (Net)|0.567|Standard Error of the Mean|4.807||0.9061|2-Sided|95.0|-8.866|10.001|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654669|NCT01634152|3044988|Superiority or Other||Mean Difference (Net)|4.743|Standard Error of the Mean|4.747||0.3179|2-Sided|95.0|-4.571|14.057|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654670|NCT01634152|3044988|Superiority or Other||Mean Difference (Net)|4.776|Standard Error of the Mean|4.686||0.3083|2-Sided|95.0|-4.419|13.97|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654671|NCT01634152|3044989|Superiority or Other||Mean Difference (Net)|-0.026|Standard Error of the Mean|0.067||0.7034|2-Sided|95.0|-0.158|0.107|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654672|NCT01634152|3044989|Superiority or Other||Mean Difference (Net)|0.035|Standard Error of the Mean|0.067||0.6029|2-Sided|95.0|-0.096|0.165|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654673|NCT01634152|3044990|Superiority or Other||Mean Difference (Net)|-0.087|Standard Error of the Mean|0.075||0.2461|2-Sided|95.0|-0.233|0.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654674|NCT01634152|3044990|Superiority or Other||Mean Difference (Net)|-0.015|Standard Error of the Mean|0.074||0.8361|2-Sided|95.0|-0.16|0.129|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654675|NCT01634152|3044991|Superiority or Other||Mean Difference (Net)|-0.089|Standard Error of the Mean|0.126||0.4789|2-Sided|95.0|-0.336|0.158|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654676|NCT01634152|3044991|Superiority or Other||Mean Difference (Net)|0.017|Standard Error of the Mean|0.124||0.8916|2-Sided|95.0|-0.227|0.261|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654677|NCT01634152|3044993|Superiority or Other||Mean Difference (Net)|-0.079|Standard Error of the Mean|0.079||0.3166|2-Sided|95.0|-0.233|0.076|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654678|NCT01634152|3044993|Superiority or Other||Mean Difference (Net)|0.02|Standard Error of the Mean|0.078||0.798|2-Sided|95.0|-0.133|0.173|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654679|NCT01634152|3044996|Superiority or Other||Mean Difference (Net)|0.037|Standard Error of the Mean|0.032||0.2545|2-Sided|95.0|-0.026|0.1|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654680|NCT01634152|3044996|Superiority or Other||Mean Difference (Net)|-0.041|Standard Error of the Mean|0.032||0.2008|2-Sided|95.0|-0.103|0.022|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654681|NCT01634152|3044997|Superiority or Other||Mean Difference (Net)|0.126|Standard Error of the Mean|0.03|<|0.0001|2-Sided|95.0|0.068|0.184|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654682|NCT01634152|3044997|Superiority or Other||Mean Difference (Net)|0.031|Standard Error of the Mean|0.029|<|0.2907|2-Sided|95.0|-0.026|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654683|NCT01634152|3044998|Superiority or Other||Mean Difference (Net)|0.009|Standard Error of the Mean|0.038||0.8194|2-Sided|95.0|-0.066|0.083|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654684|NCT01634152|3044998|Superiority or Other||Mean Difference (Net)|-0.048|Standard Error of the Mean|0.037||0.203|2-Sided|95.0|-0.121|0.026|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654685|NCT01634152|3044999|Superiority or Other||Mean Difference (Net)|0.03|Standard Error of the Mean|0.036||0.3998|2-Sided|95.0|-0.04|0.101|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654686|NCT01634152|3044999|Superiority or Other||Mean Difference (Net)|-0.043|Standard Error of the Mean|0.036||0.2277|2-Sided|95.0|-0.113|0.027|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654687|NCT01634152|3045000|Superiority or Other||Mean Difference (Net)|0.087|Standard Error of the Mean|0.034||0.0117|2-Sided|95.0|0.019|0.154|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis for this endpoint was performed in a stepwise manner after the analysis of the primary endpoint was performed. Each step was only considered confirmatory if all previous steps were successful.|
1654688|NCT01634152|3045000|Superiority or Other||Mean Difference (Net)|0.018|Standard Error of the Mean|0.034||0.5898|2-Sided|95.0|-0.048|0.085|||Mixed Models Analysis|Repeated measures restricted maximum likelihood|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis for this endpoint was performed in a stepwise manner after the analysis of the primary endpoint was performed. Each step was only considered confirmatory if all previous steps were successful.|
1654689|NCT01634152|3045001|Superiority or Other||Mean Difference (Net)|0.139|Standard Error of the Mean|0.033|<|0.0001|2-Sided|95.0|0.075|0.203|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.|
1654690|NCT01634152|3045001|Superiority or Other||Mean Difference (Net)|0.035|Standard Error of the Mean|0.032|<|0.2724|2-Sided|95.0|-0.028|0.099|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.|
1654691|NCT01634139|3045002|Superiority or Other||Median Difference (Net)|0.028|Standard Error of the Mean|0.043||0.5089|2-Sided|95.0|-0.056|0.133|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654692|NCT01634139|3045002|Superiority or Other||Median Difference (Net)|0.019|Standard Error of the Mean|0.043||0.6541|2-Sided|95.0|-0.066|0.104|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654693|NCT01634139|3045002|Superiority or Other||Mean Difference (Net)|0.037|Standard Error of the Mean|0.043||0.388|2-Sided|95.0|-0.047|0.121|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654694|NCT01634139|3045002|Superiority or Other||Mean Difference (Net)|0.041|Standard Error of the Mean|0.043||0.3375|2-Sided|95.0|-0.043|0.125|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654695|NCT01634139|3045003|Superiority or Other||Median Difference (Net)|-0.054|Standard Error of the Mean|0.057||0.3457|2-Sided|95.0|-0.165|0.058|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654696|NCT01634139|3045003|Superiority or Other||Median Difference (Net)|0.003|Standard Error of the Mean|0.057||0.9627|2-Sided|95.0|-0.109|0.114|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654697|NCT01634139|3045003|Superiority or Other||Mean Difference (Net)|-0.093|Standard Error of the Mean|0.056||0.0959|2-Sided|95.0|-0.204|0.017|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654698|NCT01634139|3045003|Superiority or Other||Mean Difference (Net)|-0.045|Standard Error of the Mean|0.056||0.4221|2-Sided|95.0|-0.156|0.065|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654699|NCT01634139|3045004|Superiority or Other||Median Difference (Net)|-0.035|Standard Error of the Mean|0.047||0.4586|2-Sided|95.0|-0.126|0.057|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654700|NCT01634139|3045004|Superiority or Other||Median Difference (Net)|-0.012|Standard Error of the Mean|0.047||0.799|2-Sided|95.0|-0.104|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654701|NCT01634139|3045004|Superiority or Other||Mean Difference (Net)|-0.106|Standard Error of the Mean|0.046||0.0222|2-Sided|95.0|-0.196|-0.015|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654702|NCT01634139|3045004|Superiority or Other||Mean Difference (Net)|-0.043|Standard Error of the Mean|0.046||0.3498|2-Sided|95.0|-0.135|0.048|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654703|NCT01634139|3045005|Superiority or Other||Median Difference (Net)|-0.032|Standard Error of the Mean|0.046||0.4872|2-Sided|95.0|-0.123|0.059|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654704|NCT01634139|3045005|Superiority or Other||Median Difference (Net)|-0.012|Standard Error of the Mean|0.047||0.8019|2-Sided|95.0|-0.103|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654705|NCT01634139|3045005|Superiority or Other||Mean Difference (Net)|-0.059|Standard Error of the Mean|0.046||0.1982|2-Sided|95.0|-0.149|0.031|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1655013|NCT01628042|3045632|Superiority or Other||Geometric least-squares mean ration|1.68|||||2-Sided|90.0|1.07|2.63|||||||
1654706|NCT01634139|3045005|Superiority or Other||Mean Difference (Net)|-0.031|Standard Error of the Mean|0.046||0.5004|2-Sided|95.0|-0.122|0.06|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654707|NCT01634139|3045006|Superiority or Other||Median Difference (Net)|-0.051|Standard Error of the Mean|0.049||0.3022|2-Sided|95.0|-0.148|0.046|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654708|NCT01634139|3045006|Superiority or Other||Median Difference (Net)|-0.01|Standard Error of the Mean|0.05||0.8372|2-Sided|95.0|-0.108|0.088|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654709|NCT01634139|3045006|Superiority or Other||Mean Difference (Net)|-0.059|Standard Error of the Mean|0.049||0.2293|2-Sided|95.0|-0.155|0.037|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654710|NCT01634139|3045006|Superiority or Other||Mean Difference (Net)|-0.039|Standard Error of the Mean|0.049||0.4359|2-Sided|95.0|-0.135|0.058|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654711|NCT01634139|3045007|Superiority or Other||Median Difference (Net)|-0.043|Standard Error of the Mean|0.047||0.3552|2-Sided|95.0|-0.136|0.04|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654712|NCT01634139|3045007|Superiority or Other||Median Difference (Net)|-0.053|Standard Error of the Mean|0.047||0.2623|2-Sided|95.0|-0.145|0.04|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654713|NCT01634139|3045007|Superiority or Other||Mean Difference (Net)|-0.082|Standard Error of the Mean|0.046||0.0794|2-Sided|95.0|-0.173|0.01|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654714|NCT01634139|3045007|Superiority or Other||Mean Difference (Net)|0.001|Standard Error of the Mean|0.047||0.988|2-Sided|95.0|-0.091|0.092|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654715|NCT01634139|3045008|Superiority or Other||Median Difference (Net)|-0.026|Standard Error of the Mean|0.036||0.4714|2-Sided|95.0|-0.097|0.045|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654716|NCT01634139|3045008|Superiority or Other||Median Difference (Net)|-0.03|Standard Error of the Mean|0.036||0.4086|2-Sided|95.0|-0.101|0.041|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654717|NCT01634139|3045008|Superiority or Other||Mean Difference (Net)|-0.075|Standard Error of the Mean|0.036||0.0369|2-Sided|95.0|-0.145|-0.005|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654718|NCT01634139|3045008|Superiority or Other||Mean Difference (Net)|-0.009|Standard Error of the Mean|0.036||0.7931|2-Sided|95.0|-0.08|0.061|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654719|NCT01634139|3045010|Superiority or Other||Mean Difference (Net)|0.01|Standard Error of the Mean|0.074||0.8922|2-Sided|95.0|-0.136|0.156|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654720|NCT01634139|3045010|Superiority or Other||Mean Difference (Net)|-0.061|Standard Error of the Mean|0.075||0.4127|2-Sided|95.0|-0.208|0.085|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654721|NCT01634139|3045010|Superiority or Other||Mean Difference (Net)|0.141|Standard Error of the Mean|0.074||0.0561|2-Sided|95.0|-0.004|0.286|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654722|NCT01634139|3045010|Superiority or Other||Mean Difference (Net)|0.166|Standard Error of the Mean|0.074||0.0256|2-Sided|95.0|0.02|0.312|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654723|NCT01634139|3045011|Superiority or Other||Mean Difference (Net)|0.07|Standard Error of the Mean|0.077||0.3648|2-Sided|95.0|-0.082|0.222|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654724|NCT01634139|3045011|Superiority or Other||Mean Difference (Net)|0.035|Standard Error of the Mean|0.078||0.6547|2-Sided|95.0|-0.118|0.187|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654725|NCT01634139|3045011|Superiority or Other||Mean Difference (Net)|0.125|Standard Error of the Mean|0.077||0.1043|2-Sided|95.0|-0.026|0.276|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654726|NCT01634139|3045011|Superiority or Other||Mean Difference (Net)|0.191|Standard Error of the Mean|0.077||0.0139|2-Sided|95.0|0.039|0.343|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654727|NCT01634139|3045012|Superiority or Other||Mean Difference (Net)|0.004|Standard Error of the Mean|0.085||0.9655|2-Sided|95.0|-0.163|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654728|NCT01634139|3045012|Superiority or Other||Mean Difference (Net)|-0.018|Standard Error of the Mean|0.085||0.8291|2-Sided|95.0|-0.185|0.149|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654729|NCT01634139|3045012|Superiority or Other||Mean Difference (Net)|0.126|Standard Error of the Mean|0.084||0.1351|2-Sided|95.0|-0.039|0.292|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654730|NCT01634139|3045012|Superiority or Other||Mean Difference (Net)|0.175|Standard Error of the Mean|0.085||0.0392|2-Sided|95.0|0.009|0.341|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654731|NCT01634139|3045013|Superiority or Other||Mean Difference (Net)|0.017|Standard Error of the Mean|0.072||0.8082|2-Sided|95.0|-0.124|0.158|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1655091|NCT01625091|3046228|Superiority|||||||0.36|||||||Chi-squared||||
1654732|NCT01634139|3045013|Superiority or Other||Mean Difference (Net)|-0.021|Standard Error of the Mean|0.072||0.7654|2-Sided|95.0|-0.163|0.12|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654733|NCT01634139|3045013|Superiority or Other||Mean Difference (Net)|0.127|Standard Error of the Mean|0.071||0.0747|2-Sided|95.0|-0.013|0.267|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654734|NCT01634139|3045013|Superiority or Other||Mean Difference (Net)|0.176|Standard Error of the Mean|0.072||0.0144|2-Sided|95.0|0.035|0.316|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654735|NCT01634139|3045015|Superiority or Other||Mean Difference (Net)|-0.093|Standard Error of the Mean|0.073||0.1985|2-Sided|95.0|-0.236|0.049|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654736|NCT01634139|3045015|Superiority or Other||Mean Difference (Net)|-0.065|Standard Error of the Mean|0.073||0.3732|2-Sided|95.0|-0.208|0.078|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654737|NCT01634139|3045015|Superiority or Other||Mean Difference (Net)|-0.182|Standard Error of the Mean|0.072||0.0116|2-Sided|95.0|-0.323|-0.041|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654738|NCT01634139|3045015|Superiority or Other||Mean Difference (Net)|-0.12|Standard Error of the Mean|0.072||0.0975|2-Sided|95.0|-0.262|0.022|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654739|NCT01634139|3045016|Superiority or Other||Mean Difference (Net)|-0.043|Standard Error of the Mean|0.05||0.3897|2-Sided|95.0|-0.141|0.055|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654740|NCT01634139|3045016|Superiority or Other||Mean Difference (Net)|0.006|Standard Error of the Mean|0.05||0.9|2-Sided|95.0|-0.092|0.105|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654741|NCT01634139|3045016|Superiority or Other||Mean Difference (Net)|-0.076|Standard Error of the Mean|0.049||0.1267|2-Sided|95.0|-0.173|0.021|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654742|NCT01634139|3045016|Superiority or Other||Mean Difference (Net)|-0.025|Standard Error of the Mean|0.05||0.6166|2-Sided|95.0|-0.122|0.073|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654743|NCT01634139|3045017|Superiority or Other||Mean Difference (Net)|-0.015|Standard Error of the Mean|0.048||0.7597|2-Sided|95.0|-0.109|0.08|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654744|NCT01634139|3045017|Superiority or Other||Mean Difference (Net)|0.024|Standard Error of the Mean|0.048||0.625|2-Sided|95.0|-0.071|0.118|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654745|NCT01634139|3045017|Superiority or Other||Mean Difference (Net)|-0.065|Standard Error of the Mean|0.048||0.1741|2-Sided|95.0|-0.158|0.029|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654746|NCT01634139|3045017|Superiority or Other||Mean Difference (Net)|0.019|Standard Error of the Mean|0.048||0.6932|2-Sided|95.0|-0.075|0.113|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654747|NCT01634139|3045018|Superiority or Other||Mean Difference (Net)|-0.579|Standard Error of the Mean|1.059||0.5845|2-Sided|95.0|-2.656|1.498|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654748|NCT01634139|3045018|Superiority or Other||Mean Difference (Net)|0.272|Standard Error of the Mean|1.058||0.7975|2-Sided|95.0|-1.803|2.346|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654749|NCT01634139|3045018|Superiority or Other||Mean Difference (Net)|0.166|Standard Error of the Mean|1.041||0.8731|2-Sided|95.0|-1.875|2.208|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654750|NCT01634139|3045018|Superiority or Other||Mean Difference (Net)|0.262|Standard Error of the Mean|1.039||0.8008|2-Sided|95.0|-1.775|2.299|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654751|NCT01634139|3045019|Superiority or Other||Mean Difference (Net)|4.176|Standard Error of the Mean|5.481||0.4463|2-Sided|95.0|-6.578|14.929|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654752|NCT01634139|3045019|Superiority or Other||Mean Difference (Net)|-1.882|Standard Error of the Mean|5.497||0.7322|2-Sided|95.0|-12.667|8.904|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654753|NCT01634139|3045019|Superiority or Other||Mean Difference (Net)|14.146|Standard Error of the Mean|5.427||0.0093|2-Sided|95.0|3.497|24.794|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654754|NCT01634139|3045019|Superiority or Other||Mean Difference (Net)|12.36|Standard Error of the Mean|5.451||0.0236|2-Sided|95.0|1.663|23.056|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654755|NCT01634139|3045020|Superiority or Other||Mean Difference (Net)|8.774|Standard Error of the Mean|5.413||0.1053|2-Sided|95.0|-1.847|19.394|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654756|NCT01634139|3045020|Superiority or Other||Mean Difference (Net)|5.538|Standard Error of the Mean|5.435||0.3085|2-Sided|95.0|-5.127|16.203|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654757|NCT01634139|3045020|Superiority or Other||Mean Difference (Net)|7.493|Standard Error of the Mean|5.365||0.1628|2-Sided|95.0|-3.034|18.02|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654758|NCT01634139|3045020|Superiority or Other||Mean Difference (Net)|8.507|Standard Error of the Mean|5.387||0.1146|2-Sided|95.0|-2.063|19.077|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654759|NCT01634139|3045021|Superiority or Other||Mean Difference (Net)|-0.103|Standard Error of the Mean|0.062||0.0983|2-Sided|95.0|-0.224|0.019|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654760|NCT01634139|3045021|Superiority or Other||Mean Difference (Net)|-0.099|Standard Error of the Mean|0.062||0.1105|2-Sided|95.0|-0.221|0.023|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654761|NCT01634139|3045021|Superiority or Other||Mean Difference (Net)|-0.126|Standard Error of the Mean|0.061||0.0404|2-Sided|95.0|-0.246|-0.006|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654762|NCT01634139|3045021|Superiority or Other||Mean Difference (Net)|-0.096|Standard Error of the Mean|0.062||0.1182|2-Sided|95.0|-0.217|0.025|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654763|NCT01634139|3045022|Superiority or Other||Mean Difference (Net)|-0.131|Standard Error of the Mean|0.066||0.0464|2-Sided|95.0|-0.26|-0.002|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654764|NCT01634139|3045022|Superiority or Other||Mean Difference (Net)|-0.125|Standard Error of the Mean|0.066||0.0581|2-Sided|95.0|-0.255|0.004|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654765|NCT01634139|3045022|Superiority or Other||Mean Difference (Net)|-0.141|Standard Error of the Mean|0.065||0.0305|2-Sided|95.0|-0.269|-0.013|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654766|NCT01634139|3045022|Superiority or Other||Mean Difference (Net)|-0.116|Standard Error of the Mean|0.065||0.0749|2-Sided|95.0|-0.245|0.012|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654767|NCT01634139|3045023|Superiority or Other||Mean Difference (Net)|-0.201|Standard Error of the Mean|0.111||0.0709|2-Sided|95.0|-0.419|0.017|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654768|NCT01634139|3045023|Superiority or Other||Mean Difference (Net)|-0.154|Standard Error of the Mean|0.111||0.1675|2-Sided|95.0|-0.372|0.065|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654769|NCT01634139|3045023|Superiority or Other||Mean Difference (Net)|-0.209|Standard Error of the Mean|0.11||0.0588|2-Sided|95.0|-0.425|0.008|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654770|NCT01634139|3045023|Superiority or Other||Mean Difference (Net)|-0.165|Standard Error of the Mean|0.11||0.1349|2-Sided|95.0|-0.382|0.051|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654771|NCT01634139|3045024|Superiority or Other||Mean Difference (Net)|0.092|Standard Error of the Mean|0.038||0.0156|2-Sided|95.0|0.017|0.166|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|3 hours post-dose (Week 24)|
1654772|NCT01634139|3045024|Superiority or Other||Median Difference (Net)|0.115|Standard Error of the Mean|0.038||0.0025|2-Sided|95.0|0.041|0.19|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|3 hours post-dose (week 24)|
1654773|NCT01634139|3045024|Superiority or Other||Median Difference (Net)|0.093|Standard Error of the Mean|0.037||0.013|2-Sided|95.0|0.02|0.166|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|2 hours post-dose (week 24)|
1654774|NCT01634139|3045024|Superiority or Other||Median Difference (Net)|0.113|Standard Error of the Mean|0.037||0.0027|2-Sided|95.0|0.039|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|2 hours post-dose (week 24)|
1654775|NCT01634139|3045024|Superiority or Other||Median Difference (Net)|0.06|Standard Error of the Mean|0.037||0.1044|2-Sided|95.0|-0.012|0.132|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|1 hour post-dose (week 24)|
1654776|NCT01634139|3045024|Superiority or Other||Mean Difference (Net)|0.109|Standard Error of the Mean|0.037||0.0032|2-Sided|95.0|0.037|0.182|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|1 hour post-dose (week 24)|
1654777|NCT01634139|3045024|Superiority or Other||Median Difference (Net)|0.067|Standard Error of the Mean|0.037||0.0696|2-Sided|95.0|-0.005|0.139|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|30 minutes post-dose (Week 24)|
1654778|NCT01634139|3045024|Superiority or Other||Median Difference (Net)|0.078|Standard Error of the Mean|0.037||0.0344|2-Sided|95.0|0.006|0.15|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|30 minutes post-dose (Week 24)|
1654779|NCT01634139|3045024|Superiority or Other||Mean Difference (Net)|0.052|Standard Error of the Mean|0.04||0.198|2-Sided|95.0|-0.027|0.131|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|10 minutes pre-dose.(Week 24)|
1654780|NCT01634139|3045024|Superiority or Other||Mean Difference (Net)|0.092|Standard Error of the Mean|0.04||0.0228|2-Sided|95.0|0.013|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|10 minutes pre-dose (Week 24)|
1654781|NCT01634139|3045025|Superiority or Other||Mean Difference (Net)|0.076|Standard Error of the Mean|0.034||0.0255|2-Sided|95.0|0.009|0.143|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654782|NCT01634139|3045025|Superiority or Other||Mean Difference (Net)|0.105|Standard Error of the Mean|0.034||0.0023|2-Sided|95.0|0.037|0.172|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654837|NCT01633853|3045065|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||The levels of blood 25(OH)Vitamin D were compared between the 24th month and the baseline in group Vitamin D2.|
1654783|NCT01634139|3045026|Superiority or Other||Median Difference (Net)|0.053|Standard Error of the Mean|0.04||0.188|2-Sided|95.0|-0.026|0.133|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654784|NCT01634139|3045026|Superiority or Other||Median Difference (Net)|0.062|Standard Error of the Mean|0.04||0.1256|2-Sided|95.0|-0.017|0.141|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654785|NCT01634139|3045026|Superiority or Other||Mean Difference (Net)|0.052|Standard Error of the Mean|0.04||0.198|2-Sided|95.0|-0.027|0.131|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654786|NCT01634139|3045026|Superiority or Other||Mean Difference (Net)|0.092|Standard Error of the Mean|0.04||0.0228|2-Sided|95.0|0.013|0.171|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654787|NCT01634139|3045027|Superiority or Other||Median Difference (Net)|0.052|Standard Error of the Mean|0.038||0.1666|2-Sided|95.0|-0.022|0.126|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654788|NCT01634139|3045027|Superiority or Other||Median Difference (Net)|0.069|Standard Error of the Mean|0.038||0.0687|2-Sided|95.0|-0.005|0.143|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654789|NCT01634139|3045027|Superiority or Other||Mean Difference (Net)|0.091|Standard Error of the Mean|0.037||0.0152|2-Sided|95.0|0.018|0.165|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654790|NCT01634139|3045027|Superiority or Other||Mean Difference (Net)|0.11|Standard Error of the Mean|0.038||0.0036|2-Sided|95.0|0.036|0.184|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654791|NCT01634139|3045028|Superiority or Other||Mean Difference (Net)|0.176|Standard Error of the Mean|0.032|<|0.0001|2-Sided|95.0|0.114|0.238|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|3 hours post-dose (Week 24)|
1654792|NCT01634139|3045028|Superiority or Other||Mean Difference (Net)|0.178|Standard Error of the Mean|0.032|<|0.0001|2-Sided|95.0|0.116|0.24|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|3 hours post-dose (Week 24)|
1654793|NCT01634139|3045028|Superiority or Other||Mean Difference (Net)|0.168|Standard Error of the Mean|0.032|<|0.0001||95.0|0.106|0.231|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|2 hours post-dose (Week 24)|
1654794|NCT01634139|3045028|Superiority or Other||Median Difference (Net)|0.163|Standard Error of the Mean|0.032|<|0.0001|2-Sided|95.0|0.101|0.226|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|2 hours post-dose (Week 24)|
1654795|NCT01634139|3045028|Superiority or Other||Mean Difference (Net)|0.147|Standard Error of the Mean|0.032|<|0.0001|2-Sided|95.0|0.084|0.21|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|1 hour post-dose (Week 24)|
1654796|NCT01634139|3045028|Superiority or Other||Mean Difference (Net)|0.148|Standard Error of the Mean|0.032|<|0.0001|2-Sided|95.0|0.084|0.211|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|1 hour post-dose (Week 24)|
1654797|NCT01634139|3045028|Superiority or Other||Median Difference (Net)|0.151|Standard Error of the Mean|0.032|<|0.0001|2-Sided|95.0|0.088|0.213|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|30 minutes post-dose (Week 24)|
1654798|NCT01634139|3045028|Superiority or Other||Median Difference (Net)|0.139|Standard Error of the Mean|0.032|<|0.0001|2-Sided|95.0|0.076|0.201|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|30 minutes post-dose (Week 24)|
1654799|NCT01634139|3045028|Superiority or Other||Mean Difference (Net)|0.118|Standard Error of the Mean|0.036|<|0.001|2-Sided|95.0|0.048|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|10 minutes pre-dose (Week 24)|
1654800|NCT01634139|3045028|Superiority or Other||Mean Difference (Net)|0.116|Standard Error of the Mean|0.036|<|0.0012|2-Sided|95.0|0.046|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|10 minutes pre-dose (Week 24)|
1654801|NCT01634139|3045029|Superiority or Other||Mean Difference (Net)|0.157|Standard Error of the Mean|0.03|<|0.0001|2-Sided|95.0|0.098|0.215|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654802|NCT01634139|3045029|Superiority or Other||Mean Difference (Net)|0.154|Standard Error of the Mean|0.03|<|0.0001|2-Sided|95.0|0.095|0.212|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654803|NCT01634139|3045030|Superiority or Other||Mean Difference (Net)|0.127|Standard Error of the Mean|0.031|<|0.0001|2-Sided|95.0|0.065|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo||
1654804|NCT01634139|3045030|Superiority or Other||Mean Difference (Net)|0.124|Standard Error of the Mean|0.031|<|0.0001|2-Sided|95.0|0.062|0.185|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo||
1654805|NCT01634139|3045031|Superiority or Other||Median Difference (Net)|0.099|Standard Error of the Mean|0.036||0.0059|2-Sided|95.0|0.029|0.17|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 48|
1654806|NCT01634139|3045031|Superiority or Other||Mean Difference (Net)|0.071|Standard Error of the Mean|0.036||0.0477|2-Sided|95.0|0.001|0.142|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 48|
1654807|NCT01634139|3045031|Superiority or Other||Mean Difference (Net)|0.118|Standard Error of the Mean|0.036||0.001|2-Sided|95.0|0.048|0.188|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Week 24|
1654808|NCT01634139|3045031|Superiority or Other||Mean Difference (Net)|0.116|Standard Error of the Mean|0.036||0.0012|2-Sided|95.0|0.046|0.186|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Week 24|
1654809|NCT01634139|3045032|Superiority or Other||Mean Difference (Net)|0.164|Standard Error of the Mean|0.031|<|0.0001|2-Sided|95.0|0.103|0.255|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.|
1654810|NCT01634139|3045032|Superiority or Other||Mean Difference (Net)|0.17|Standard Error of the Mean|0.031|<|0.0001|2-Sided|95.0|0.108|0.231|||Mixed Models Analysis|Repeated measures restricted maximum likelihood model|Difference calculated as Tio R2.5 minus placebo|Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo. The analysis was performed in a stepwise manner, firstly for this endpoint, then Trough FEV1. Each step was only considered confirmatory if all previous steps were successful.|
1654811|NCT01634113|3045040|Superiority or Other||Mean Difference (Net)|-0.075|Standard Error of the Mean|0.116||0.523|2-Sided|95.0|-0.305|0.156||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo||
1654812|NCT01634113|3045040|Superiority or Other||Mean Difference (Net)|0.061|Standard Error of the Mean|0.112||0.5869|2-Sided|95.0|-0.161|0.283||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo||
1654813|NCT01634113|3045042|Superiority or Other||Mean Difference (Net)|-2.497|Standard Error of the Mean|10.826||0.8181|2-Sided|95.0|-23.987|18.994||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo||
1654814|NCT01634113|3045042|Superiority or Other||Mean Difference (Net)|2.25|Standard Error of the Mean|10.324||0.8279|2-Sided|95.0|-18.243|22.743||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo||
1654815|NCT01634113|3045043|Superiority or Other||Mean Difference (Net)|0.015|Standard Error of the Mean|0.16||0.9251|2-Sided|95.0|-0.303|0.333||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo||
1654816|NCT01634113|3045043|Superiority or Other||Mean Difference (Net)|0.083|Standard Error of the Mean|0.157||0.5995|2-Sided|95.0|-0.229|0.394||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo||
1654817|NCT01634113|3045045|Superiority or Other||Mean Difference (Net)|-0.048|Standard Error of the Mean|0.123||0.6936|2-Sided|95.0|-0.292|0.195||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R5 minus placebo||
1654818|NCT01634113|3045045|Superiority or Other||Mean Difference (Net)|-0.08|Standard Error of the Mean|0.117||0.4963|2-Sided|95.0|-0.312|0.152||All treatment comparisons were exploratory, no formal hypothesis testing was performed.|ANCOVA||Difference calculated as Tio R2.5 minus placebo||
1654819|NCT01634100|3045046|Non-Inferiority or Equivalence|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|153.61|Standard Deviation|7.5|||2-Sided|90.0|146.5|161.06|||||Standard deviation is actually the intra-subject coefficient of variation.||
1654820|NCT01634100|3045046|Non-Inferiority or Equivalence|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|136.42|Standard Deviation|7.5|||2-Sided|90.0|130.61|142.48|||||Standard deviation is actually the intra-subject coefficient of variation.||
1654821|NCT01634100|3045047|Non-Inferiority or Equivalence|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|125.6|Standard Deviation|15.9|||2-Sided|90.0|113.67|138.78|||||Standard deviation is actually the intra-subject coefficient of variation.||
1654822|NCT01634100|3045047|Non-Inferiority or Equivalence|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|175.14|Standard Deviation|15.4|||2-Sided|90.0|160.14|191.56|||||Standard deviation is actually the intra-subject coefficient of variation.||
1654823|NCT01634100|3045048|Non-Inferiority or Equivalence|Ratio calculated as empa plus probenecid divided by empa|Geometric Mean Ratio|153.47|Standard Deviation|7.4|||2-Sided|90.0|146.41|160.88|||||Standard deviation is actually the intra-subject coefficient of variation.||
1654824|NCT01634100|3045048|Non-Inferiority or Equivalence|Ratio calculated as empa and rifampicin divided by empa|Geometric Mean Ratio|135.2|Standard Deviation|7.3|||2-Sided|90.0|129.58|141.06|||||Standard deviation is actually the intra-subject coefficient of variation.||
1654825|NCT01633944|3045055|Superiority or Other|||||||0.0754|||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥50% pain reduction|
1654826|NCT01633944|3045055|Superiority or Other|||||||0.0012|||||||Cochran-Mantel-Haenszel|Stratified by stratum (dose level)||Responders with ≥30% pain reduction|
1654827|NCT01633944|3045056|Superiority or Other||Median Difference (Net)|-0.67||||0.0012|2-Sided|95.0|-1.07|-0.26|||ANCOVA||||
1654828|NCT01633853|3045062|Superiority or Other|||||||0.463||||||t=-0.736|t-test, 2 sided|||The levels of blood iPTH at the 24th month of following up were compared between two groups.|
1654829|NCT01633853|3045062|Superiority or Other|||||||0.106|||||||t-test, 2 sided|||The levels of blood iPTH were compared between the 24th month and the baseline group 1,25(OH)2 Vitamin D3, respectively.|
1654830|NCT01633853|3045062|Superiority or Other|||||||0.179|||||||t-test, 2 sided|||The levels of blood iPTH were compared between the 24th month and the baseline in group Vitamin D2.|
1654831|NCT01633853|3045063|Superiority or Other|||||||0.694||||||t=0.394|t-test, 2 sided|||The levels of blood phosphorus at the 24th month of following up were compared between two groups.|
1654832|NCT01633853|3045063|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||The levels of blood phosphorus were compared between the 24th month of following up and the baseline in group 1,25(OH)2 Vitamin D3, respectively.|
1654833|NCT01633853|3045063|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||The levels of blood phosphorus were compared between the 24th month of following up and the baseline in group Vitamin D2.|
1654834|NCT01633853|3045064|Superiority or Other|||||||0.753||||||Chi-square value=0.099|Chi-squared||||
1654835|NCT01633853|3045065|Superiority or Other||||||<|0.001||||||P<0.001, t=-14.982.|t-test, 2 sided|||The levels of blood 25(OH) Vitamin D at the 24th month of following up were compared between two groups.|
1655014|NCT01628042|3045632|Superiority or Other||Geometric least-squares mean ratio|1.42|||||2-Sided|90.0|0.89|2.27|||||||
1654839|NCT01633853|3045066|Superiority or Other|||||||0.309|||||||t-test, 2 sided|||The blood levels of calcium at the 24th month of following up were compared to the levels of the baseline in group 1,25(OH)2 Vitamin D3.|
1654840|NCT01633853|3045066|Superiority or Other|||||||0.117|||||||t-test, 2 sided|||The blood levels of calcium at the 24th month of following up were compared to the levels of the baseline both in group Vitamin D2.|
1654841|NCT01633827|3045067|Superiority or Other||Mean Difference (Final Values)|0.001||||0.001|2-Sided||||||t-test, 2 sided||||
1654842|NCT01633827|3045068|Superiority or Other||Mean Difference (Final Values)|0.5||||0.5|2-Sided||||||t-test, 2 sided||||
1654843|NCT01633827|3045069|Superiority or Other||Mean Difference (Final Values)|0.5||||0.5|2-Sided||||||t-test, 2 sided||||
1654844|NCT01633827|3045070|Superiority or Other||Mean Difference (Final Values)|0.025||||0.025|2-Sided||||||t-test, 2 sided||||
1654845|NCT01633827|3045071|Superiority or Other||Mean Difference (Final Values)|0.05||||0.05|2-Sided||||||t-test, 2 sided||||
1654846|NCT01633112|3045079|Other|||||||0.1358|||||||ANCOVA|rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume|||
1654847|NCT01633112|3045079|Other|||||||0.1045|||||||ANCOVA|rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume|||
1654848|NCT01633112|3045080|Other|||||||0.4595|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline|||
1654849|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline|||
1654850|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 12): p-values for within treatment comparison from baseline|||
1654851|NCT01633112|3045080|Other||||||<|0.0068|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline|||
1654852|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline|||
1654853|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Convenience (Month 6): p-values for within treatment comparison from baseline|||
1654854|NCT01633112|3045080|Other||||||<|0.0051|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline|||
1654855|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline|||
1654856|NCT01633112|3045080|Other||||||<|0.0051|||||||Wilcoxon signed-rank test|Side Effects (Month 12): p-values for within treatment comparison from baseline|||
1654857|NCT01633112|3045080|Other||||||<|0.0005|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline|||
1654858|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline|||
1654859|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Side Effects (Month 6): p-values for within treatment comparison from baseline|||
1654860|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline|||
1654861|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline|||
1654862|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 12): p-values for within treatment comparison from baseline|||
1654863|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline|||
1654864|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline|||
1654865|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Effectiveness (Month 6): p-values for within treatment comparison from baseline|||
1654866|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline|||
1654867|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline|||
1654868|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 12): p-values for within treatment comparison from baseline|||
1654869|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline|||
1654870|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline|||
1654871|NCT01633112|3045080|Other||||||<|0.0001|||||||Wilcoxon signed-rank test|Global Satisfaction (Month 6): p-values for within treatment comparison from baseline|||
1654872|NCT01633112|3045081|Other|||||||0.0146||||||adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.|Regression, Logistic|pair-wise comparisons between treatment groups using a logistic regression model.|||
1654873|NCT01633112|3045081|Other|||||||0.0011||||||adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.|Regression, Logistic|pair-wise comparisons between treatment groups using a logistic regression model.|||
1654874|NCT01633112|3045082|Other|||||||0.0636|||||||ANCOVA|ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.|||
1654875|NCT01633112|3045082|Other|||||||0.0052|||||||ANCOVA|ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.|||
1654876|NCT01633112|3045083|Other|||||||0.0011|||||||negative binomial regression model|adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.|||
1654877|NCT01633112|3045083|Other|||||||0.0167|||||||negative binomial regression model|adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses .|||
1654878|NCT01633112|3045084|Other|||||||0.006|||||||ANCOVA|rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.|||
1654879|NCT01633112|3045084|Other||||||<|0.0001|||||||ANCOVA|rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.|||
1654880|NCT01633112|3045086|Other||||||<|0.0001|||||||negative binomial regression model|Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.|||
1654881|NCT01633112|3045086|Other||||||<|0.0001|||||||negative binomial regression model|Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.|||
1654882|NCT01633112|3045087|Superiority|For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.||||||0.4153|||||||negative binomial regression model|adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.||H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA|
1654883|NCT01633112|3045087|Superiority|For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.||||||0.0138|||||||negative binomial regression model|adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.||H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA|
1654884|NCT01633060|3045098|Other|Comparison of progression-free survival (PFS) (based on local investigator assessment) between the two treatment groups using a stratified log-rank test at one-sided 2.5% level of significance|Hazard Ratio (HR)|0.67|||<|0.001|1-Sided|95.0|0.53||||Log Rank||||
1654885|NCT01632904|3045111|Superiority or Other||Odds Ratio (OR)|1.82||||0.139|2-Sided|95.0|0.82|4.04|||Chi-squared||||
1654886|NCT01632891|3045118|Superiority|Test used alpha level of 0.05||||||1|||||||Fisher Exact|||Compare proportions of Pf SCP clearance between treatment arms|
1654887|NCT01632735|3045121|Superiority or Other||Beta effect (timexcondition)|0.217|||<|0.001|2-Sided|95.0|0.2|0.233|||Mixed Models Analysis|Analyses controlled for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the outcome measure of self-help utilization (mean days in past month) over the study period (baseline, discharge, and 3-, 6-, and 9-month follow-ups).|
1654888|NCT01632735|3045122|Superiority or Other||Beta (time x condition)|0.115|||<|0.001|2-Sided|95.0|0.106|0.123|||Mixed Models Analysis|A repeated-measures model tested for effects of treatment vs. control on recovery self-confidence over time controlling for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the outcome measure of recovery confidence mean score over time.|
1654889|NCT01632735|3045123|Superiority or Other||Beta (timexcondition)|0.239|||<|0.001|2-Sided|95.0|0.219|0.248|||Mixed Models Analysis|Analyses controlled for age and gender.||Mixed modeling using a repeated-measures random-effects model was conducted to test for the effects of treatment (dummy coded with 1 = mobile intervention, 0 = control) and time as well as the treatment x time interaction on the primary outcome measures of recovery behaviors mean days over time (baseline, discharge, 3, 6, and 9-month follow-ups).|
1654890|NCT01632735|3045124|Superiority or Other||Odds Ratio (OR)|0.75|||<|0.05|2-Sided|95.0|0.57|0.99|||GEE|Generalized Estimating Equations regression examined primary relapse (measured by urinalysis) over time by condition, controlling for age and gender.|||
1654891|NCT01632345|3045157|Superiority or Other||Difference|-6.5|||||2-Sided|95.0|-14.1|0.3|||||A negative value would be considered as favoring doravirine over efavirenz.||
1654892|NCT01632345|3045158|Superiority or Other||Difference|-2.8|||||2-Sided|95.0|-11.7|6.0|||||A negative value would be considered as favoring doravirine over efavirenz.||
1654893|NCT01632345|3045159|Superiority or Other||Difference in CD4 change|-4.4|||||2-Sided|95.0|-64.0|55.1|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654894|NCT01632345|3045160|Superiority or Other||Difference in CD4 change|-2.6|||||2-Sided|95.0|-46.5|41.3|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654895|NCT01632345|3045161|Superiority or Other||Difference in CD4 change|6.3|||||2-Sided|95.0|-38.2|50.8|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654896|NCT01632345|3045162|Superiority or Other||Difference in CD4 change|19.6|||||2-Sided|95.0|-45.1|84.2|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654897|NCT01632345|3045162|Superiority or Other||Difference in CD4 change|12.5|||||2-Sided|95.0|-44.6|69.5|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654898|NCT01632345|3045162|Superiority or Other||Difference in CD4 change|-8.3|||||2-Sided|95.0|-68.5|51.9|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654899|NCT01632345|3045162|Superiority or Other||Difference in CD4 change|33.0|||||2-Sided|95.0|-28.1|94.0|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654900|NCT01632345|3045163|Superiority or Other||Difference in % response|3.9|||||2-Sided|95.0|-7.3|15.0|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654901|NCT01632345|3045164|Superiority or Other||Difference in % response|0.1|||||2-Sided|95.0|-9.7|9.9|||||A positive value would be considered as favoring doravirine over efavirenz.||
1657001|NCT01597245|3049337|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1654903|NCT01632345|3045166|Superiority or Other||Difference in % response|9.5|||||2-Sided|95.0|-6.2|25.7|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654904|NCT01632345|3045166|Superiority or Other||Difference in % response|12.2|||||2-Sided|95.0|-2.5|28.0|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654905|NCT01632345|3045166|Superiority or Other||Difference in % response|2.8|||||2-Sided|95.0|-13.9|19.8|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654906|NCT01632345|3045166|Superiority or Other||Difference in % response|4.5|||||2-Sided|95.0|-12.5|21.5|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654907|NCT01632345|3045167|Superiority or Other||Difference in % response|-0.8|||||2-Sided|95.0|-12.4|10.7|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654908|NCT01632345|3045168|Superiority or Other||Difference in % response|-1.9|||||2-Sided|95.0|-12.9|9.2|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654909|NCT01632345|3045169|Superiority or Other||Difference in % response|-0.5|||||2-Sided|95.0|-13.2|11.2|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654910|NCT01632345|3045170|Superiority or Other||Difference in % response|15.9|||||2-Sided|95.0|-3.4|34.4|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654911|NCT01632345|3045170|Superiority or Other||Difference in % response|6.6|||||2-Sided|95.0|-13.2|26.0|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654912|NCT01632345|3045170|Superiority or Other||Difference in % response|10.0|||||2-Sided|95.0|-9.6|29.1|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654913|NCT01632345|3045170|Superiority or Other||Difference in % response|15.7|||||2-Sided|95.0|-4.1|34.4|||||A positive value would be considered as favoring doravirine over efavirenz.||
1654914|NCT01632345|3045171|Superiority or Other||Difference (Doravirine - Efavirenz)|-20.4||||0.002|2-Sided|95.0|-32.6|-7.5||Superiority analysis|Miettinen and Nurminen method||A negative value would be considered as favoring doravirine over efavirenz.||
1654915|NCT01632345|3045172|Superiority or Other||Difference (Doravirine - Efavirenz)|-20.4||||0.002|2-Sided|95.0|-32.4|-7.8||Superiority analysis|Miettinen and Nurminen method||A negative value would be considered as favoring doravirine over efavirenz.||
1654916|NCT01632345|3045173|Superiority or Other||Difference|-10.2|||||2-Sided|95.0|-20.9|0.5|||||A negative value would be considered as favoring doravirine over efavirenz.||
1654917|NCT01632345|3045174|Superiority or Other||Difference (Doravirine - Efavirenz)|-4.8|||||2-Sided|95.0|-15.9|4.1|||||A negative value would be considered as favoring doravirine over efavirenz.||
1654918|NCT01632345|3045174|Superiority or Other||Difference (Doravirine - Efavirenz)|-2.4|||||2-Sided|95.0|-13.8|8.2|||||A negative value would be considered as favoring doravirine over efavirenz.||
1654919|NCT01632345|3045174|Superiority or Other||Difference (Doravirine - Efavirenz)|2.2|||||2-Sided|95.0|-9.9|14.7|||||A negative value would be considered as favoring doravirine over efavirenz.||
1654920|NCT01632345|3045174|Superiority or Other||Difference (Doravirine - Efavirenz)|-2.3|||||2-Sided|95.0|-13.7|8.8|||||A negative value would be considered as favoring doravirine over efavirenz.||
1654921|NCT01632345|3045175|Superiority or Other||Difference (Doravirine - Efavirenz)|2.0|||||2-Sided|95.0|-14.5|18.4|||||A negative value would be considered as favoring doravirine over efavirenz.||
1654922|NCT01632345|3045175|Superiority or Other||Difference (Doravirine - Efavirenz)|-11.9|||||2-Sided|95.0|-27.9|6.3|||||A negative value would be considered as favoring doravirine over efavirenz.||
1654923|NCT01632345|3045175|Superiority or Other||Difference (Doravirine - Efavirenz)|9.7|||||2-Sided|95.0|-4.6|24.9|||||A negative value would be considered as favoring doravirine over efavirenz.||
1654924|NCT01632345|3045175|Superiority or Other||Difference (Doravirine - Efavirenz)|6.7|||||2-Sided|95.0|-9.0|22.4|||||A negative value would be considered as favoring doravirine over efavirenz.||
1654925|NCT01632241|3045194|Superiority||Odds Ratio (OR)|1.3||||0.4996|2-Sided|95.0|0.61|2.8||Nominal p-value due to step-down sequential testing procedure.|Regression, Logistic||||
1654926|NCT01632241|3045196|Superiority||Hazard Ratio (HR)|0.77||||0.2264|2-Sided|95.0|0.51|1.17||Nominal p-value due to step-down sequential testing procedure.|Cox proportional hazards model||||
1654927|NCT01632241|3045198|Superiority||Odds Ratio (OR)|1.42||||0.0937|2-Sided|95.0|0.94|2.15||Nominal p-value due to step-down sequential testing procedure.|Regression, Logistic||||
1654928|NCT01632241|3045207|Superiority||Odds Ratio (OR)|1.4||||0.1068|2-Sided|95.0|0.93|2.11|||Regression, Logistic||||
1654929|NCT01632215|3045208|Superiority||Mean Difference (Net)|0.3|||<|0.05|2-Sided||||||t-test, 1 sided||||
1654930|NCT01631747|3045243|Superiority|||||||0.94|||||||t-test, 2 sided||||
1654931|NCT01631747|3045244|Superiority|||||||0.66|||||||t-test, 2 sided||||
1654932|NCT01631747|3045245|Superiority|||||||0.25|||||||t-test, 2 sided||||
1654933|NCT01631747|3045246|Superiority|||||||0.42|||||||t-test, 2 sided||||
1654934|NCT01631747|3045247|Superiority|||||||0.61|||||||t-test, 2 sided||||
1654935|NCT01631747|3045248|Superiority|||||||0.62|||||||t-test, 2 sided||||
1654936|NCT01631747|3045249|Superiority|||||||0.26|||||||t-test, 2 sided|T-test performed on change between groups (log scale). Median and IQR are presented for ease of interpretation|||
1654937|NCT01631747|3045250|Superiority|||||||0.32|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation|||
1654938|NCT01631747|3045251|Superiority|||||||0.24|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation|||
1654939|NCT01631747|3045252|Superiority|||||||0.003|||||||t-test, 2 sided|t-test performed on changes between groups (log scale). Median and IQR are presented for ease of interpretation|||
1654940|NCT01631747|3045253|Superiority|||||||0.27|||||||t-test, 2 sided|t-test used to compare changes between groups (log scale). Median and IQR are presented for ease of interpretation.|||
1654941|NCT01631747|3045254|Superiority|||||||0.19|||||||t-test, 2 sided|t-test run on change between groups (log scale), but presented as median and IQR for ease of interpretation|||
1654942|NCT01631747|3045255|Superiority|||||||0.69|||||||t-test, 2 sided|t-test run on changes between groups. Data presented as median and IQR for ease of interpretation|||
1654943|NCT01631747|3045256|Superiority|||||||0.3|||||||t-test, 2 sided|t-test performed on changes in HDL, but presented as median and IQR for ease of interpretation|||
1654944|NCT01631747|3045257|Superiority|||||||0.89|||||||t-test, 2 sided|T-test performed on change in glucose (log scale), but presented as Median and inter-quartile range for interpretability|||
1654945|NCT01631747|3045258|Superiority|||||||0.54|||||||Chi-squared||||
1654946|NCT01631747|3045259|Superiority|||||||0.02|||||||Regression, Linear|adjusted for actual gestational age of 36 week weight, gestational age, bmi, and maternal age at randomization, maternal race and paternal race.|||
1654947|NCT01631747|3045259|Superiority|||||||0.01||||||p-value is not adjusted for multiple comparisons, and tested at an a priori type I error rate of 0.05.|t-test, 2 sided|||Sample size was based on an independent 2-sample t-test using a two-sided type 1 error rate of 0.05, and 80% power. Assuming a standard deviation (SD) of 15lbs (6.8kg), a clinically meaningful difference of 5lbs (2.4kg) between groups, and 10% attrition, a sample size of 150/group was required.|
1654948|NCT01631682|3045260|Superiority or Other||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after intranasal oxytocin was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).|
1654949|NCT01631682|3045260|Superiority or Other||||||<|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after mifepristone was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).|
1654950|NCT01631682|3045260|Superiority or Other||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was initially presented (CS+R) and then followed by a series of extinction trials after a 10-min delay would result in a smaller SCR than a conditioned stimulus (CS+N) that was not extinguished without a 10-min delay.|
1654951|NCT01631682|3045260|Superiority or Other||||||>|0.05|||||||ANOVA|||This study used a within-groups design. Each subject provides his/her own comparison data. It was predicted that that a conditioned stimulus that was reactivated (CS+R) after propranolol was administered would result in a smaller SCR than a conditioned stimulus that was not reactivated (CS+N).|
1654952|NCT01631214|3045321|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|3.6|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|3.18|3.97|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.|
1654953|NCT01631214|3045322|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|3.7|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|3.29|4.02|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.|
1654954|NCT01631214|3045323|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|LS Mean Difference|7.4|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|6.84|7.89|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.|
1654955|NCT01631214|3045324|Superiority|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.2|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|2.9|3.54|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.|
1654956|NCT01631214|3045325|Superiority|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.3|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|3.03|3.6|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.|
1654957|NCT01631214|3045326|Superiority|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|8.7|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|8.31|9.09|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.|
1654981|NCT01631214|3045344|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.49|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|0.37|0.64|||Regression, Logistic|Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values < 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).||
1654958|NCT01631214|3045327|Superiority|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.8|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|3.4|4.14|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.|
1654959|NCT01631214|3045328|Superiority|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|3.8|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|3.42|4.1|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an ANCOVA model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.|
1654960|NCT01631214|3045329|Superiority|If the differences in both primary end points were significant with the use of the Hochberg procedure, a fixed-sequence testing procedure was used for bone mineral density and the key secondary end point of nonvertebral fracture to adjust for multiple comparisons and to maintain an overall significance level of 0.05.|LS Mean Difference|8.1|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|7.58|8.57|||ANCOVA|||Between-group comparisons of the percent change from baseline in bone mineral density were analyzed using an analysis of covariance (ANCOVA) model adjusted for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.|
1654961|NCT01631214|3045330|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.56|Standard Error of the Mean|0.39||0.14|2-Sided|95.0|0.26|1.22|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654962|NCT01631214|3045331|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|Standard Error of the Mean|0.17||0.053|2-Sided|95.0|0.52|1.01|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654963|NCT01631214|3045332|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.64|Standard Error of the Mean|0.34||0.19|2-Sided|95.0|0.33|1.26|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654964|NCT01631214|3045333|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.74|Standard Error of the Mean|0.16||0.057|2-Sided|95.0|0.54|1.01|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654965|NCT01631214|3045334|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.71|Standard Error of the Mean|0.11||0.002|2-Sided|95.0|0.57|0.88|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654966|NCT01631214|3045335|Superiority||Absolute risk reduction|1.84|Standard Error of the Mean|0.68|||2-Sided|95.0|0.51|3.17||||||"The absolute risk reduction (difference in percentages, Alendronate – Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, > -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."|
1654967|NCT01631214|3045335|Superiority||Risk Ratio (RR)|0.64|Standard Error of the Mean|0.17|||2-Sided|95.0|0.46|0.89|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, > -2.5).~Values < 1 for risk ratio favor romosozumab."|
1654968|NCT01631214|3045335|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.63|Standard Error of the Mean|0.18||0.008|2-Sided|95.0|0.44|0.89|||Regression, Logistic|Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values < 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).||
1655007|NCT01628549|3045556|Superiority||Difference in Least Squares Means|1.53||||0.4344|2-Sided|95.0|-2.32|5.38|||ANCOVA||||
1655008|NCT01628523|3045557|Superiority or Other (legacy)||Odds Ratio (OR)|1.08|||<|0.05|2-Sided||||||Regression, Logistic||||
1655009|NCT01628042|3045631|Superiority or Other||Geometric least squares mean ratio|0.67|||||2-Sided|90.0|0.5|0.9|||||||
1654969|NCT01631214|3045336|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|Standard Error of the Mean|0.15||0.027|2-Sided|95.0|0.54|0.96|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654970|NCT01631214|3045337|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.41|Standard Error of the Mean|0.28|<|0.001|2-Sided|95.0|0.24|0.71|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654971|NCT01631214|3045338|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.72|Standard Error of the Mean|0.24||0.17|2-Sided|95.0|0.46|1.15|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654972|NCT01631214|3045339|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.81|Standard Error of the Mean|0.12||0.074|2-Sided|95.0|0.64|1.02|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654973|NCT01631214|3045340|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.74|Standard Error of the Mean|0.11||0.005|2-Sided|95.0|0.59|0.91|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654974|NCT01631214|3045341|Superiority||Absolute risk reduction|1.21|Standard Error of the Mean|0.45|||2-Sided|95.0|0.33|2.1||||||"The absolute risk reduction (difference in percentages, Alendronate – Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, > -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."|
1654975|NCT01631214|3045341|Superiority||Risk Ratio (RR)|0.52|Standard Error of the Mean|0.25|||2-Sided|95.0|0.32|0.85|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, > -2.5).~Values < 1 for risk ratio favor romosozumab."|
1654976|NCT01631214|3045341|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Odds Ratio (OR)|0.51|Standard Error of the Mean|0.25||0.008|2-Sided|95.0|0.31|0.85|||Regression, Logistic|Based on logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values < 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).||
1654977|NCT01631214|3045342|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.62|Standard Error of the Mean|0.2||0.015|2-Sided|95.0|0.42|0.92|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654978|NCT01631214|3045343|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.73|Standard Error of the Mean|0.11||0.004|2-Sided|95.0|0.59|0.9|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654979|NCT01631214|3045344|Superiority||Absolute risk reduction|4.44|Standard Error of the Mean|0.84|||2-Sided|95.0|2.8|6.08||||||"The absolute risk reduction (difference in percentages, Alendronate – Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, > -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."|
1654980|NCT01631214|3045344|Superiority||Risk Ratio (RR)|0.52|Standard Error of the Mean|0.13|||2-Sided|95.0|0.4|0.66|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, > -2.5).~Values < 1 for risk ratio favor romosozumab."|
1655010|NCT01628042|3045631|Superiority or Other||Geometric least squares mean ratio|0.49|||||2-Sided|90.0|0.36|0.65|||||||
1655011|NCT01628042|3045631|Superiority or Other||Geometric least squares mean ratio|0.55|||||2-Sided|90.0|0.41|0.74|||||||
1657002|NCT01597245|3049337|Superiority or Other||||||<|0.008|||||||Cochran-Mantel-Haenszel||||
1654982|NCT01631214|3045345|Superiority|This endpoint was not included in the sequential testing procedure and was analyzed without multiplicity adjustment at a significance level of 0.05 (two-sided).|Hazard Ratio (HR)|0.65|Standard Error of the Mean|0.08|<|0.001|2-Sided|95.0|0.56|0.76|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654983|NCT01631214|3045346|Superiority|If the 2 primary endpoints and the specified BMD secondary endpoints were all significant, the nonvertebral fracture at the primary analysis was evaluated based on a 1-sided test (overall α=0.025) determined by the Lan-DeMets alpha spending function that approximates a Pocock boundary, 0.0233 (1-sided).|Hazard Ratio (HR)|0.81|Standard Error of the Mean|0.1||0.04|2-Sided|95.0|0.66|0.99||The adjusted 2-sided p-value is reported.|Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|"Based on Cox proportional hazards model adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.~Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)."||
1654984|NCT01631214|3045347|Superiority|The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 p-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.|Hazard Ratio (HR)|0.73|Standard Error of the Mean|0.09|<|0.001|2-Sided|95.0|0.61|0.88|||Regression, Cox|Model adjusted for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.|Hazard ratio < 1 favors romosozumab; SE represents the standard error of log (hazard ratio)||
1654985|NCT01631214|3045348|Superiority||Absolute risk reduction|4.03|Standard Error of the Mean|0.78|||2-Sided|95.0|2.5|5.57||||||"The absolute risk reduction (difference in percentages, Alendronate – Romosozumab) was based on the Mantel-Haenszel method adjusted for age strata, baseline total hip BMD T-score (≤ -2.5, > -2.5), and presence of severe vertebral fracture at baseline.~Positive values for absolute risk reduction favor romosozumab."|
1654986|NCT01631214|3045348|Superiority||Risk Ratio (RR)|0.5|Standard Error of the Mean|0.14|||2-Sided|95.0|0.38|0.66|||||SE represents the standard error of log (risk ratio).|"The risk ratio (ratio of percentages, Romosozumab:Alendronate) was based on the Mantel Haenszel method, adjusted for age strata (<75 vs. ≥75 years), the presence or absence of severe vertebral fracture at baseline, and baseline bone mineral density T-score at the total hip (≤ -2.5, > -2.5).~Values < 1 for risk ratio favor romosozumab."|
1654987|NCT01631214|3045348|Superiority|The primary endpoints were tested at the 5% level (2-sided), accounting for multiplicity using the Hochberg procedure. If the larger of the 2 p-values was significant at the 0.05 level (2-sided), the statistical testing continued to the secondary endpoint in the testing sequence.|Odds Ratio (OR)|0.48|Standard Error of the Mean|0.15|<|0.001|2-Sided|95.0|0.36|0.64|||Regression, Logistic|Based on a logistic regression model adjusted for age strata, baseline total hip BMD T-score and presence of severe vertebral fracture at baseline.|Values < 1 for odds ratio favor romosozumab. The standard error (SE) represents the standard error of log(odds ratio).||
1654988|NCT01631149|3045353|Superiority or Other||Mean Difference (Net)|0.7|Standard Deviation|0.4|<|0.001|||||||t-test, 2 sided|||"The individual scores obtained during surgery were averaged.~The average values were compared using a t-test between treatments."|
1654989|NCT01630616|3045369|Superiority or Other||Ratio (Adolescents/Adults)|0.81|||||2-Sided|90.0|0.57|1.16|||||||
1654990|NCT01630616|3045370|Superiority or Other||Ratio (Adolescents/Adults)|0.87|||||2-Sided|90.0|0.62|1.23|||||||
1654991|NCT01630616|3045371|Superiority or Other||Ratio (Adolescents/adults)|0.89|||||2-Sided|90.0|0.62|1.26|||||||
1654992|NCT01630135|3045403|Superiority or Other||Least Squares Mean Difference|-1.089|||<|0.001|2-Sided|95.0|-1.41|-0.76|||ANCOVA||The analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for Treatment, Baseline, Age, and Sex.||
1654993|NCT01629966|3045408|Superiority||Least Squares Mean Difference|-1.52||||0.0349|2-Sided|95.0|-2.94|-0.11|||MMRM||||
1654994|NCT01629966|3045408|Superiority||Least Squares Mean Difference|-1.37||||0.0536|2-Sided|95.0|-2.75|0.02|||MMRM||||
1654995|NCT01629966|3045409|Superiority||Least Squares Mean Difference|-1.8||||0.0156|2-Sided|95.0|-3.26|-0.34|||MMRM||||
1654996|NCT01629966|3045409|Superiority||Least Squares Mean Difference|-1.27||||0.083|2-Sided|95.0|-2.71|0.17|||MMRM||||
1654997|NCT01629823|3045413|Superiority or Other||Risk Ratio (RR)|0.84||||0.57|2-Sided|95.0|0.47|1.52|||Regression, Linear||||
1654998|NCT01629823|3045413|Superiority or Other||Risk Ratio (RR)|0.81||||0.51|2-Sided|95.0|0.44|1.5||Comparison of 5cm group to control. No adjustment for multiple comparisons.|Regression, Linear|||Both the 5 and 10cm groups were compared to the control group, <1cm H₂O|
1654999|NCT01629667|3045458|Superiority or Other||Least square mean difference|-1.41||||0.234|2-Sided|95.0|-3.73|0.91|||ANCOVA||||
1655000|NCT01629667|3045458|Superiority or Other||Least square mean difference|-1.77||||0.14|2-Sided|95.0|-4.13|0.59|||ANCOVA||||
1655001|NCT01628718|3045529|Non-Inferiority|The NI margin for CAPS-IV scores was established a priori, based on a calculation of a reliable difference from baseline to posttreatment CAPS-IV scores from a previous trial (10 points). If the 95% confidence interval (CI) around the estimate does not contain the NI margin, we can reject the null hypothesis and accept the alternative hypothesis. .|Mean Difference (Final Values)|0.33||||0.05|2-Sided|95.0|-10.1|9.44||one-tailed|Regression, Linear||Mean difference is the difference in mean CAPS-IV change scores (pre-post) between AD and CPT-C.|Null hypothesis: AD is inferior to CPT Alternative hypothesis: AD is non-inferior to CPT-C|
1655002|NCT01628549|3045555|Superiority||Difference vs placebo in success rate|4.1||||0.4834|2-Sided|95.0|-7.44|15.87|||Cochran-Mantel-Haenszel||||
1655003|NCT01628549|3045555|Superiority||Difference vs placebo in success rate|13.2||||0.0159|2-Sided|95.0|0.54|25.6|||Cochran-Mantel-Haenszel||||
1655004|NCT01628549|3045555|Superiority||Difference vs placebo in success rate|3.4||||0.33|2-Sided|95.0|-7.82|14.38|||Cochran-Mantel-Haenszel||||
1655005|NCT01628549|3045556|Superiority||Difference in Least Squares Means|4.37||||0.0317|2-Sided|95.0|0.39|8.36|||ANCOVA||||
1655006|NCT01628549|3045556|Superiority||Difference in Least Squares Means|4.46||||0.0266|2-Sided|95.0|0.52|8.4|||ANCOVA||||
1655015|NCT01628042|3045633|Superiority or Other||Geometric least-squares mean ratio|1.49|||||2-Sided|90.0|1.11|2.0|||||||
1655016|NCT01628042|3045633|Superiority or Other||Geometric least-squares mean ratio|2.06|||||2-Sided|90.0|1.55|2.74|||||||
1655017|NCT01628042|3045633|Superiority or Other||Geometric least-squares mean ratio|1.83|||||2-Sided|90.0|1.36|2.46|||||||
1655018|NCT01628016|3045635|Other||Mean Difference (Final Values)|3.98||||0.05|2-Sided|95.0|||||Mixed Models Analysis||||
1655019|NCT01627860|3045642|Superiority or Other||Difference in mean percent change|18.3||||0.7102|2-Sided|95.0|-81.0|117.7|||ANCOVA||Difference in mean percent change of seizure frequency (Monotherapy minus Add on therapy)||
1655020|NCT01627860|3045643|Superiority or Other||Difference in Seizure free rate|23.57||||0.0759|2-Sided|95.0|-4.21|49.0|||ANOVA||Difference in Seizure free rate (Monotherapy minus Add on therapy)||
1655021|NCT01627782|3045659|Superiority or Other||Difference of Least Square Means|-16.4|||<|0.001|2-Sided|70.0|-18.96|-13.84|||Mixed Effect Model Repeated Measure||||
1655022|NCT01627782|3045659|Superiority or Other||Difference of Least Square Means|-16.0|||<|0.001|2-Sided|70.0|-20.0|-12.01|||Mixed Effect Model Repeated Measure||||
1655023|NCT01627327|3045706|Superiority or Other||Median Difference (Net)|0.022||||0.201|2-Sided|95.0|-0.012|0.055|||ANCOVA||||
1655024|NCT01627249|3045720|Superiority or Other (legacy)||Mean Difference (Final Values)|1.1||||0.69|2-Sided|95.0|-0.9|3.1|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab|
1655025|NCT01627249|3045720|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.4||||0.69|2-Sided|95.0|-2.3|1.5|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Ranibizumab|
1655026|NCT01627249|3045720|Superiority or Other (legacy)||Mean Difference (Final Values)|0.7||||0.69|2-Sided|95.0|-1.3|2.7|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Bevacizumab|
1655027|NCT01627249|3045721|Superiority or Other (legacy)||Mean Difference (Final Values)|1.8||||0.21|2-Sided|95.0|-1.1|4.8|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab|
1655028|NCT01627249|3045721|Superiority or Other (legacy)||Mean Difference (Final Values)|4.7||||0.0031|2-Sided|95.0|1.4|8.0|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Ranibizumab|
1655029|NCT01627249|3045721|Superiority or Other (legacy)||Mean Difference (Final Values)|6.5||||0.001|2-Sided|95.0|2.9|10.1|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Bevacizumab|
1655030|NCT01627249|3045722|Superiority or Other (legacy)||Mean Difference (Final Values)|-51.2|||<|0.001|2-Sided|95.0|-71.2|-31.3|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs Bevacizumab|
1655031|NCT01627249|3045722|Superiority or Other (legacy)||Mean Difference (Final Values)|-18.6|||<|0.036|2-Sided|95.0|-36.0|-1.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Ranibizumab|
1655032|NCT01627249|3045722|Superiority or Other (legacy)||Mean Difference (Final Values)|-69.9|||<|0.001|2-Sided|95.0|-91.1|-48.6|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs Bevacizumab|
1655033|NCT01627249|3045723|Superiority or Other (legacy)||Mean Difference (Final Values)|1.4||||0.12|2-Sided|95.0|-0.4|3.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Ranibizumab vs. Bevacizumab|
1655034|NCT01627249|3045723|Superiority or Other (legacy)||Mean Difference (Final Values)|2.1||||0.034|2-Sided|95.0|0.1|4.2|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Ranibizumab|
1655035|NCT01627249|3045723|Superiority or Other (legacy)||Mean Difference (Final Values)|3.5|||<|0.001|2-Sided|95.0|1.4|5.7|||ANCOVA||Reported P-values have been adjusted for multiple treatment group comparisons.|Aflibercept vs. Bevacizumab|
1655036|NCT01626989|3045745|Non-Inferiority or Equivalence|Friedman Test comparing all 3 nights||||||0.001|||||||nonparametric Wilcoxon Signed Rank test||||
1655037|NCT01626118|3045784|Superiority or Other|||||||0.577|||||||t-test, 2 sided||||
1655038|NCT01626118|3045784|Superiority or Other|||||||0.017|||||||t-test, 2 sided||||
1655039|NCT01626118|3045784|Superiority or Other|||||||0.036|||||||t-test, 2 sided||||
1655040|NCT01626118|3045785|Superiority or Other|||||||0.447|||||||t-test, 2 sided||||
1655041|NCT01626118|3045785|Superiority or Other|||||||0.012|||||||t-test, 2 sided||||
1655042|NCT01626118|3045785|Superiority or Other|||||||0.021|||||||t-test, 2 sided||||
1655043|NCT01626118|3045786|Superiority or Other|||||||0.593|||||||t-test, 2 sided||||
1655044|NCT01626118|3045786|Superiority or Other|||||||0.02|||||||t-test, 2 sided||||
1655045|NCT01626118|3045786|Superiority or Other|||||||0.049|||||||t-test, 2 sided||||
1655046|NCT01626118|3045787|Superiority or Other|||||||0.716|||||||t-test, 2 sided||||
1655047|NCT01626118|3045787|Superiority or Other|||||||0.071|||||||t-test, 2 sided||||
1655048|NCT01626118|3045787|Superiority or Other|||||||0.141|||||||t-test, 2 sided||||
1655049|NCT01626118|3045788|Superiority or Other|||||||0.441|||||||t-test, 2 sided||||
1655050|NCT01626118|3045788|Superiority or Other|||||||0.021|||||||t-test, 2 sided||||
1655051|NCT01626118|3045788|Superiority or Other|||||||0.02|||||||t-test, 2 sided||||
1655052|NCT01626118|3045789|Superiority or Other|||||||0.458|||||||t-test, 2 sided||||
1655053|NCT01626118|3045789|Superiority or Other|||||||0.041|||||||t-test, 2 sided||||
1655054|NCT01626118|3045789|Superiority or Other|||||||0.079|||||||t-test, 2 sided||||
1655055|NCT01626118|3045790|Superiority or Other|||||||0.461|||||||t-test, 2 sided||||
1655056|NCT01626118|3045790|Superiority or Other|||||||0.108|||||||t-test, 2 sided||||
1655057|NCT01626118|3045790|Superiority or Other|||||||0.191|||||||t-test, 2 sided||||
1655086|NCT01625286|3046206|Superiority|A hazard ratio < 1 favours AZD5363|Hazard Ratio (HR)|0.8||||0.308|2-Sided|80.0|0.6|1.06||2-sided p-value|Regression, Cox|Cox PH model including treatment and PIK3CA status as factors/covariates|||
1655087|NCT01625182|3046213|Superiority or Other||Hazard Ratio (HR)|1.0||||0.9838|2-Sided|95.0|0.6|1.7|||Regression, Cox||||
1655058|NCT01626118|3045791|Superiority or Other||Difference in Least Squares Mean|341.232|Standard Error of the Mean|102.7761|<|0.001|2-Sided|95.0|139.249|543.215|||Mixed Models Analysis|||The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than “imputing” a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter.|
1655059|NCT01626118|3045791|Superiority or Other||Difference in Least Squares Mean|511.357|Standard Error of the Mean|102.5851|<|0.001|2-Sided|95.0|309.749|712.965|||Mixed Models Analysis|||The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than “imputing” a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter.|
1655060|NCT01626118|3045791|Superiority or Other||Difference in Least Squares Mean|503.008|Standard Error of the Mean|102.3149|<|0.001|2-Sided|95.0|301.93|704.086|||Mixed Models Analysis|||The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than “imputing” a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter.|
1655061|NCT01626118|3045791|Superiority or Other||Difference in Least Squares Mean|61.972|Standard Error of the Mean|150.2717|<|0.68|2-Sided|95.0|-233.527|357.471|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.|
1655062|NCT01626118|3045791|Superiority or Other||Difference in Least Squares Mean|342.132|Standard Error of the Mean|150.0397|<|0.023|2-Sided|95.0|47.09|637.175|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.|
1655063|NCT01626118|3045791|Superiority or Other||Difference in Least Squares Mean|317.612|Standard Error of the Mean|149.6694|<|0.034|2-Sided|95.0|23.297|611.926|||ANCOVA|||The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.|
1655064|NCT01626079|3046098|Superiority||Win Ratio|1.61|||<|0.0001|2-Sided|95.0|1.29|2.04|||Finkelstein-Schoenfeld Analysis||||
1655065|NCT01626079|3046099|Superiority||Hazard Ratio (HR)|0.76|||<|0.02|2-Sided|95.0|0.6|0.96|||Joint Fraility Model||||
1655066|NCT01626079|3046132|Non-Inferiority|Two thousand (2000) simulations were performed to calculate sample size and power for the primary safety endpoint. Assuming 22% mortality and 7.5% attrition at 12 months, a total of 305 subjects in the Device group will provide > 95% power to reject the null hypothesis at the one-sided significance level of 5%.|Kaplan Meier|0.966|Standard Error of the Mean|0.011|<|0.0001|1-Sided|95.0|0.948||||Z test Using Kaplan Meier Survival|P-value calculated from Z test using Kaplan Meier survival estimate together with Greenwood method estimated variance|||
1655067|NCT01625923|3046140|Other|T-test comparing GCSI-DD scores before/after intervention||||||0.06|||||||t-test, 2 sided||||
1655068|NCT01625910|3046142|Superiority or Other||Mean Difference (Net)|-0.17|Standard Error of the Mean|0.2|||2-Sided|95.0|-0.74|0.4||||||unadjusted net difference between groups|
1655069|NCT01625910|3046143|Superiority or Other||Mean Difference (Net)|0.06|Standard Error of the Mean|0.05|||2-Sided|95.0|-0.1|0.21||||||Baseline data by group assignment status (intervention or control) using means of the calculated BMI z-scores (U.S. CDC-2000 growth charts) implemented by applying the published LMS (shape, median, and scale) age- and sex/gender-specific parameters. Because of random assignment of a reasonably large number of children, an unadjusted analysis of change in outcomes between intervention and control groups is presented as well as the covariate-adjusted analysis of differences in changes.|
1655070|NCT01625845|3046144|Superiority or Other|||||||0.026|||||||ANCOVA||||
1655071|NCT01625845|3046145|Superiority or Other|||||||0.869|||||||ANCOVA||||
1655072|NCT01625845|3046146|Superiority or Other|||||||0.906|||||||ANCOVA||||
1655073|NCT01625845|3046147|Superiority or Other|||||||0.203|||||||ANCOVA||||
1655074|NCT01625845|3046148|Superiority or Other|||||||0.296|||||||ANCOVA||||
1655075|NCT01625845|3046149|Superiority or Other|||||||0.068|||||||ANCOVA||||
1655076|NCT01625845|3046150|Superiority or Other|||||||0.474|||||||ANCOVA||||
1655077|NCT01625689|3046155|Superiority or Other||||||>=|0||||||No comparison between the LAIV and placebo groups by type of solicited reaction had a p-value below 0.498.|Fisher Exact||||
1655078|NCT01625416|3046174|Superiority|||||||0.71|||||||Chi-squared|Chi-Square (2) =0.68, p=0.71|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.
1655079|NCT01625416|3046175|Superiority|||||||0.97||||||Chi square (2) = 0.06, p = 0.97|Chi-squared||||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.
1655080|NCT01625416|3046178|Superiority|||||||0.69|||||||Chi-squared|Chi square(2) = 0.74, p = 0.69|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.
1655081|NCT01625416|3046179|Superiority|||||||0.05|||||||Chi-squared|Chi square (2) =5.9, p=0.05|||This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.
1655082|NCT01625377|3046192|Superiority or Other||Mean Difference (Net)|-14.34|||<|0.0001|2-Sided|95.0|-21.34|-7.34|||ANCOVA||||
1655083|NCT01625286|3046198|Superiority|A hazard ratio < 1 favours AZD5363|Hazard Ratio (HR)|0.77||||0.482|2-Sided|80.0|0.48|1.24||2-sided p-value|Log Rank|Cox PH model including treatment and PIK3CA status as factors/covariates|||
1655084|NCT01625286|3046199|Superiority||Odds Ratio (OR)|1.53||||0.139|2-Sided|80.0|0.93|2.54||1-sided p-value|Regression, Logistic|including treatment and PIK3CA status as factors/covariates|||
1655085|NCT01625286|3046205|Superiority||Mean Difference (Final Values)|-8.9||||0.081|2-Sided|80.0|-17.1|-0.8||1-sided p-value|ANCOVA||||
1655088|NCT01625091|3046225|Superiority|||||||0.98|||||||t-test, 2 sided||||
1655092|NCT01624974|3046240|Superiority||Difference in Least Squares (LS) Means|0.047||||0.282|2-Sided|95.0|-0.039|0.134|||LDA model|The LDA model assumes that repeated measurements follow a multivariate normal distribution.|||
1655093|NCT01624948|3046241|Superiority or Other|||||||0.49|||||||Wilcoxon (Mann-Whitney)||||
1655094|NCT01624948|3046243|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1655095|NCT01624948|3046244|Superiority or Other|||||||0.67|||||||Wilcoxon (Mann-Whitney)|||Difference in p70S6 kinase phosphorylation as measured by mean fluorescence intensity (MFI) between those patients who reached the primary endpoint and those who did not|
1655096|NCT01624948|3046246|Superiority or Other|||||||0.53|||||||Fisher Exact||||
1655097|NCT01624740|3046249|Superiority or Other|||||||0.74|||||||ANOVA|Period effect p=0.11|||
1655098|NCT01624259|3046297|Superiority or Other||LS Mean Difference|1.43|Standard Error of the Mean|2.79||0.608|2-Sided|95.0|-4.06|6.92|||ANCOVA|No adjustment for multiplicity.|||
1655099|NCT01624259|3046298|Superiority or Other||Odds Ratio (OR)|1.02||||0.925|2-Sided|95.0|0.64|1.63||No adjustment for multiplicity.|Regression, Logistic|P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model).||Treatment comparison for HbA1c levels <7.0%.|
1655100|NCT01624259|3046298|Superiority or Other||Odds Ratio (OR)|1.23||||0.322|2-Sided|95.0|0.81|1.86||P-value of treatment comparison at Week 26 is from repeated generalized linear mixed model (GLM model).|Regression, Logistic|No adjustment for multiplicity.||Treatment comparison for HbA1c levels ≤6.5%|
1655101|NCT01624259|3046299|Superiority or Other||LS Mean Difference|-2.25|Standard Error of the Mean|1.86||0.228|2-Sided|95.0|-5.91|1.41||No adjustment for multiplicity.|Mixed Models Analysis|P-value from pairwise comparison of LS means at 26 weeks from REML-based MMRM.|||
1655102|NCT01624259|3046300|Superiority or Other||LS Mean Difference|-0.57|Standard Error of the Mean|2.61||0.828|2-Sided|95.0|-5.69|4.56||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model.|
1655103|NCT01624259|3046301|Superiority or Other||LS Mean Difference|0.25|Standard Error of the Mean|0.1||0.013|2-Sided|95.0|0.05|0.45||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model.|
1655104|NCT01624259|3046302|Superiority or Other||LS Mean Difference|0.71|Standard Error of the Mean|0.28||0.01|2-Sided|95.0|0.17|1.26||No adjustment for multiplicity.|ANCOVA|||Treatment comparison from ANCOVA model at 26 weeks.|
1655105|NCT01624259|3046303|Superiority or Other||LS Mean Difference|-0.06||||0.186|2-Sided|95.0|-0.19|0.07||1-sided raw p-value (no multiplicity adjustment)|Mixed Models Analysis|||Superiority analysis|
1655106|NCT01624259|3046303|Non-Inferiority or Equivalence|"Family-wise Type I error rate was controlled by applying a serial gatekeeping strategy.~This calculation assumed a 0 difference in HbA1c between the 1.5 mg LY2189265 1.5-mg arm and 1.8 mg liraglutide, 0.4% margin of noninferiority, common Standard Deviation (SD) of 1.3% for change from baseline in HbA1c, 0.05 two-sided significance level, and 25% dropout rate at 26 weeks."|LS Mean Difference|-0.06|||<|0.001|2-Sided|95.0|-0.19|0.07||1-sided raw p-value (no multiplicity adjustment).|Mixed Models Analysis|||To show noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide with 90% power, 222 completers (444 total) at 26 weeks were required. Noninferiority of 1.5 mg LY2189265 relative to 1.8 mg liraglutide was demonstrated if the upper bound of the two‑sided 95% Confidence Interval (CI) for the difference in mean change in HbA1c between the 1.5 mg LY2189265 arm and 1.8 mg liraglutide arm was below 0.4%.|
1655107|NCT01624194|3046328|Other||||||>|0.05||||||For all blood pressure analyses.|Mixed Models Analysis||||
1655108|NCT01624194|3046329|Other||||||>|0.05|||||||Mixed Models Analysis||||
1655109|NCT01624194|3046330|Other||||||>|0.05|||||||Mixed Models Analysis|A mixed-models analysis was used to compare between groups, and between baseline and Week 4.|||
1655110|NCT01624194|3046331|Other|||||||0.9757|||||||General Linear Model (GLM)||||
1655111|NCT01624194|3046339|Other|||||||0.3395|||||||General Linear Model (GLM)||||
1655112|NCT01624194|3046342|Other||||||>|0.05|||||||Mixed Models Analysis|A mixed-models analysis was used to compare between groups, and between baseline and Week 4.|||
1655113|NCT01624194|3046343|Other||||||>|0.05||||||Fisher's Exact Test was used to test for differences in adverse events between oxytocin-treated and placebo-treated individuals. A p-value of ≤0.05 would have been statistically significant.|Fisher Exact||||
1655114|NCT01624194|3046344|Other|||||||0.0275|||||||General Linear Model (GLM)||||
1655115|NCT01623752|3046395|Other|||||||0.849|||||||ANOVA|||Statistical analysis (P value) composite for all categories.|
1655116|NCT01623752|3046395|Other|||||||0.364|||||||ANOVA|||Statistical analysis (P value) composite for all categories.|
1655117|NCT01623752|3046396|Other|||||||0.386|||||||ANOVA|||Statistical analysis (P value) composite for all categories.|
1655118|NCT01623752|3046396|Other|||||||0.489|||||||ANOVA|||Statistical analysis (P value) composite for all categories.|
1655119|NCT01623752|3046397|Other|||||||0.969|||||||ANOVA|||Statistical analysis (P value) composite for all categories.|
1655120|NCT01623752|3046397|Other|||||||0.015|||||||ANOVA|||Statistical analysis (P value) composite for all categories.|
1655121|NCT01623752|3046398|Other|||||||0.181|||||||ANOVA|||Statistical analysis (P value) composite for all categories.|
1655122|NCT01623752|3046398|Other|||||||0.106|||||||ANOVA|||Statistical analysis (P value) composite for all categories.|
1655123|NCT01623752|3046399|Other|||||||0.357|||||||Regression, Linear||||
1655124|NCT01623752|3046399|Other|||||||0.675|||||||Regression, Linear||||
1655125|NCT01623752|3046402|Other|||||||0.218|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.|
1655126|NCT01623752|3046402|Other|||||||0.251|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.|
1655127|NCT01623752|3046403|Other|||||||0.222|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.|
1655128|NCT01623752|3046403|Other|||||||0.278|||||||Paired t-test|||P-value was calculated using Paired t-test for the change in normalized progression.|
1655129|NCT01623531|3046421|Superiority|||||||1|||||||Fisher Exact|Significance (2-sided) using Fisher's Exact Test.|||
1657003|NCT01597245|3049338|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1655130|NCT01623531|3046422|Superiority||Mann-Whitney U test|432.5|Standard Error of the Mean|60.819||0.5|2-Sided||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.|
1655131|NCT01623531|3046423|Superiority||Mann-Whitney U test|437.0|Standard Error of the Mean|60.93||0.455|2-Sided||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.|
1655132|NCT01623531|3046424|Superiority||Mann-Whitney U test|530.5|Standard Error of the Mean|60.816||0.022|2-Sided||||||Wilcoxon (Mann-Whitney)||The distribution of FIBTEM MCF (maximum clot firmness) was significantly different between RiaSTAP (median = 27 mm, IQR = 24, 30), and placebo (median = 23 mm, IQR = 22, 27) groups, U-test = 530.5, SE = 60.816, p = .022).|Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that the FIBTEM MCF data was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.|
1655133|NCT01623531|3046425|Superiority||Mann-Whitney U test|428.0|Standard Error of the Mean|60.919||0.549|2-Sided||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.|
1655134|NCT01623531|3046426|Superiority||Mann-Whitney U test|472.5|Standard Error of the Mean|60.727||0.182|2-Sided||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.|
1655135|NCT01623531|3046427|Superiority||Mann-Whitney U test|418.5|Standard Error of the Mean|60.93||0.658|2-Sided||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.|
1655136|NCT01623531|3046428|Superiority||Mann-Whitney U test|494.5|Standard Error of the Mean|60.783||0.09|2-Sided||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.|
1655137|NCT01623531|3046429|Superiority||Mann-Whitney U test|396.0|Standard Error of the Mean|60.944||0.941|2-Sided||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.|
1655138|NCT01623531|3046430|Superiority||Mann-Whitney U test|335.5|Standard Error of the Mean|52.957||0.828|2-Sided||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.|
1655139|NCT01623531|3046431|Superiority||Mann-Whitney U test|337.5|Standard Error of the Mean|51.591||0.794|2-Sided||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.|
1655140|NCT01623531|3046432|Superiority||Mann-Whitney U test|450.5|Standard Error of the Mean|54.163||0.035|2-Sided||||||Wilcoxon (Mann-Whitney)|||Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that this variable was not normally distributed. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in secondary outcomes between groups 24 hours after infusion of the study drug.|
1655141|NCT01623531|3046433|Superiority||Mean Difference (Net)|-11.821|Standard Error of the Mean|8.471||0.169|2-Sided||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.||
1655142|NCT01623531|3046434|Superiority||Mean Difference (Net)|-0.321|Standard Error of the Mean|3.699||0.93|2-Sided||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.|
1655143|NCT01623531|3046435|Superiority||Mean Difference (Net)|-0.004|Standard Error of the Mean|0.0116||0.729|2-Sided||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.|
1655144|NCT01623531|3046436|Superiority||Mean Difference (Net)|-0.498|Standard Error of the Mean|0.239||0.047|2-Sided||||||t-test, 2 sided|Unequal variances assumed.|Unequal variances T-test comparing placebo to RiaSTAP.|We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug. Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals. For normally distributed data unequal variance t tests were used.|
1655145|NCT01623531|3046437|Superiority||Mann-Whitney U test|386.0|Standard Error of the Mean|47.5||0.908|2-Sided||||||Wilcoxon (Mann-Whitney)||The distributions of cumulative transfusion units did not differ significantly between patients receiving either RiaSTAP (median = 0, IQR = 0-1) or Placebo (median = 0, IQR = 0.1), U = 386, SE = 47.60, p = .908.|Normality among study outcomes was investigated with Shapiro-Wilk tests, histograms, boxplots, and graphing of residuals, revealing that the data were not normally distributed, and primary outcomes were zero inflated. Therefore, we used non-parametric Mann-Whitney U-tests with a 2-sided type I error rate of 5%. We tested the null hypothesis of no difference in primary and secondary outcomes between groups 24 hours after infusion of the study drug.|
1655146|NCT01623271|3046453|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1655147|NCT01623154|3046455|Non-Inferiority or Equivalence|Provided previously|Relative Specificity, %|100.0|||||2-Sided|95.0|94.9|100.0|||||95% confidence interval is used instead of p-value.||
1655148|NCT01623154|3046455|Non-Inferiority or Equivalence|Described previously|Relative Sensitivity, %|100.0|||||2-Sided|95.0|85.8|100.0|||||95% confidence interval is used instead of p-value.|Comparison of UHR Values obtained by UBit-IR300 and POCone were used to identify participants' H.pylori infection status. Participants with UHR value ≥ 10.0μg/min were considered positive for H.Pylori.|
1655149|NCT01623154|3046455|Non-Inferiority or Equivalence|Analyses to determine the comparability between UHR & DOB values from the 2 instruments included Deming, Passing-Bablok and regular regressions.|Intercept|-0.04|||||2-Sided|95.0|-0.3|0.01|||||95% confidence interval is used instead of p-value.|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|
1655150|NCT01623154|3046455|Non-Inferiority or Equivalence|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.995|||||2-Sided|95.0|0.99|1.0|||||95% confidence interval is used instead of p-value.||
1655151|NCT01623154|3046455|Non-Inferiority or Equivalence|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Intercept|-0.03|||||2-Sided|95.0|-0.24|0.18|||||95% confidence interval is used instead of p-value.||
1655152|NCT01623154|3046455|Non-Inferiority or Equivalence|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.99|||||2-Sided|95.0|0.987|0.993|||||95% confidence interval is used instead of p-value.||
1655153|NCT01623154|3046455|Non-Inferiority or Equivalence|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Intercept|-0.04|||||2-Sided|95.0|-0.25|0.17|||||95% confidence interval is used instead of p-value.||
1655154|NCT01623154|3046455|Non-Inferiority or Equivalence|While 40 subjects is the min req by the NCCLS guideline on method comparison (EP9-A2), we proposed to enroll a min of 60 evaluable pediatric subjects (max of 80) with at least 20 of them having a UHR value of ≥ 10.0µg/min. The expected # of positive cases is 20-30% of the subjects enrolled, we anticipated that 80 eval subj would give approximately 20 subj with a pos UHR value. The anticipated % pos/neg agreement between the 2 instruments is 95% bases on data from the adult population.|Slope|0.99|||||2-Sided|95.0|0.987|0.993|||||95% confidence interval is used instead of p-value.||
1655155|NCT01623115|3046459|Superiority or Other||LS mean difference|2.8||||0.0187|2-Sided|95.0|0.5|5.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655156|NCT01623115|3046460|Superiority or Other||Adjusted Mean Difference|-9.7||||0.0003|2-Sided|95.0|-15.0|-4.4||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655157|NCT01623115|3046461|Superiority or Other||LS mean difference|4.3||||0.0031|2-Sided|95.0|1.5|7.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655158|NCT01623115|3046462|Superiority or Other||Adjusted Mean Difference|-17.3|||<|0.0001|2-Sided|95.0|-21.5|-13.0||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655159|NCT01623115|3046463|Superiority or Other||LS mean difference|4.7|||=|0|2-Sided|95.0|2.3|7.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655160|NCT01623115|3046464|Superiority or Other||Adjusted Mean Difference|-16.0|||<|0.0001|2-Sided|95.0|-21.3|-10.6||Threshold for significance was ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655161|NCT01623115|3046465|Superiority or Other||LS mean difference|8.0|||<|0.0001|2-Sided|95.0|5.0|11.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655162|NCT01623115|3046466|Superiority or Other||Adjusted Mean Difference|-17.7|||<|0.0001|2-Sided|95.0|-22.6|-12.9||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655163|NCT01623115|3046467|Superiority or Other||Odds Ratio (OR)|240.0|||<|0.0001|2-Sided|95.0|33.9|1700.7||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655164|NCT01623115|3046468|Superiority or Other||Odds Ratio (OR)|244.9|||<|0.0001|2-Sided|95.0|34.4|1744.4||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655165|NCT01623115|3046469|Superiority or Other||Odds Ratio (OR)|156.6|||<|0.0001|2-Sided|95.0|49.7|493.7||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655166|NCT01623115|3046470|Superiority or Other||Odds Ratio (OR)|156.0|||<|0.0001|2-Sided|95.0|48.9|498.1||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655167|NCT01623115|3046471|Superiority or Other||LS mean difference|-56.2|||<|0.0001|2-Sided|95.0|-62.4|-50.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655168|NCT01623115|3046472|Superiority or Other||LS mean difference|-32.5|||<|0.0001|2-Sided|95.0|-35.7|-29.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655169|NCT01623115|3046473|Superiority or Other||LS Mean Difference|-43.7|||<|0.0001|2-Sided|95.0|-48.0|-39.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655170|NCT01623115|3046474|Superiority or Other||LS mean difference|-37.5|||<|0.0001|2-Sided|95.0|-41.2|-33.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655171|NCT01623115|3046475|Superiority or Other||LS mean difference|-38.7|||<|0.0001|2-Sided|95.0|-42.4|-35.0||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655172|NCT01623115|3046476|Superiority or Other||LS mean difference|-52.6|||<|0.0001|2-Sided|95.0|-57.5|-47.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655173|NCT01623115|3046477|Superiority or Other||LS mean difference|-52.4|||<|0.0001|2-Sided|95.0|-57.2|-47.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655174|NCT01623115|3046478|Superiority or Other||LS mean difference|-45.9|||<|0.0001|2-Sided|95.0|-49.9|-41.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655175|NCT01623115|3046479|Superiority or Other||LS mean difference|-45.8|||<|0.0001|2-Sided|95.0|-49.8|-41.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655176|NCT01623115|3046480|Superiority or Other||LS mean difference|-49.5|||<|0.0001|2-Sided|95.0|-54.2|-44.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant)|
1655177|NCT01623115|3046481|Superiority or Other||LS mean difference|-49.2|||<|0.0001|2-Sided|95.0|-53.9|-44.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655178|NCT01623115|3046482|Superiority or Other||LS mean difference|-58.1|||<|0.0001|2-Sided|95.0|-63.5|-52.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|
1655240|NCT01620528|3046706|Superiority||Difference in LS Means|-2.02|Standard Error of the Mean|0.97|<|0.039|2-Sided|95.0|-3.93|-0.11|||ANCOVA||||
1655179|NCT01623115|3046483|Superiority or Other||LS mean difference|-57.9|||<|0.0001|2-Sided|95.0|-63.3|-52.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.|
1655180|NCT01622673|3046495|Non-Inferiority or Equivalence|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.775|||||2-Sided|90.0|0.53|1.132|||||The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for MINTOX® after raltegravir / geometric least squares mean Cmax for raltegravir alone||
1655181|NCT01622673|3046495|Non-Inferiority or Equivalence|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.485|||||2-Sided|90.0|0.332|0.709|||||The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for MINTOX® before raltegravir / geometric least squares mean Cmax for raltegravir alone||
1655182|NCT01622673|3046496|Non-Inferiority or Equivalence|The hypothesis will be supported if the lower limit of the 90% CI falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.555|||||2-Sided|95.0|0.423|0.729|||||The parameter estimated, geometric least squares mean ratio, is the geometric least squares mean Cmax for MINTOX® + raltegravir / geometric least squares mean Cmax for raltegravir alone||
1655183|NCT01622673|3046496|Non-Inferiority or Equivalence|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.476|||||2-Sided|90.0|0.362|0.627|||||The parameter estimated, geometric least squares mean ratio, is geometric least squares mean Cmax for TUMS® + raltegravir / geometric least squares mean Cmax for raltegravir alone||
1655184|NCT01622673|3046497|Non-Inferiority or Equivalence|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.696|||||2-Sided|90.0|0.504|0.96|||||The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® after raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone||
1655185|NCT01622673|3046497|Non-Inferiority or Equivalence|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.485|||||2-Sided|90.0|0.351|0.669|||||The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® before raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone||
1655186|NCT01622673|3046498|Non-Inferiority or Equivalence|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.51|||||2-Sided|90.0|0.402|0.646|||||The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for MINTOX® + raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone||
1655187|NCT01622673|3046498|Non-Inferiority or Equivalence|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.445|||||2-Sided|90.0|0.35|0.565|||||The parameter estimated, geometric least squares mean ratio, is geometric least squares mean AUC0-12hrs for TUMS® + raltegravir / geometric least squares mean AUC0-12hrs for raltegravir alone||
1655188|NCT01622673|3046499|Non-Inferiority or Equivalence|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® after raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.433|||||2-Sided|90.0|0.341|0.55|||||The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for MINTOX® after raltegravir / geometric least squares mean C12hrs for raltegravir alone||
1655189|NCT01622673|3046499|Non-Inferiority or Equivalence|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for MINTOX® before raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.437|||||2-Sided|90.0|0.344|0.554|||||The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for MINTOX® before raltegravir / geometric least squares mean C12hrs for raltegravir alone||
1655190|NCT01622673|3046500|Non-Inferiority or Equivalence|The hypothesis will be supported if the lower limit of the 90% CI falls above 0.4 for the geometric least squares mean ratio for MINTOX® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.373|||||2-Sided|90.0|0.293|0.475|||||The parameter estimated, geometric least squares mean ratio, is the geometric least squares mean C12hrs for MINTOX® + raltegravir / geometric least squares mean C12hrs for raltegravir alone||
1655191|NCT01622673|3046500|Non-Inferiority or Equivalence|The hypothesis will be supported if the lower limit of the 90% confidence interval (CI) falls above 0.4 for the geometric least squares mean ratio for TUMS® + raltegravir versus raltegravir alone|Geometric Least Squares Mean Ratio|0.678|||||2-Sided|90.0|0.531|0.866|||||The parameter estimated, geometric least squares mean ratio, is geometric least squares mean C12hrs for TUMS® + raltegravir / geometric least squares mean C12hrs for raltegravir alone||
1655192|NCT01622543|3046517|Superiority||Hazard Ratio (HR)|1.24||||0.36|2-Sided|95.0|0.78|1.98|||Log Rank||||
1655193|NCT01622543|3046518|Superiority||Odds Ratio (OR)|2.09||||0.06|2-Sided|95.0|0.96|4.55|||Cochran-Mantel-Haenszel||||
1655194|NCT01622543|3046519|Superiority|||||||0.45|||||||Wilcoxon (Mann-Whitney)||||
1655195|NCT01622543|3046520|Superiority||Hazard Ratio (HR)|1.59||||0.046|2-Sided|95.0|1.0|2.53|||Log Rank||||
1655196|NCT01622296|3046522|Superiority or Other|||||||0.57||||||Significant at p<0.05|t-test, 2 sided|||Long buccal nerve injection - H(0): Lidocaine VAS score = Buffered Lidocaine VAS score. Based on data from medial trials of buffered anesthetic, a power calculation for sample size indicated that 20 subjects would provide a 90% change of detecting an effect size of 0.83 (a change of 0.83 standard deviations)|
1657004|NCT01597245|3049338|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1655197|NCT01622296|3046522|Superiority or Other|||||||0.23||||||Significant at p<0.05|t-test, 2 sided|||Inferior Alveolar nerve injection - H(0): Lidocaine VAS score = Buffered Lidocaine VAS score. Based on data from medial trials of buffered anesthetic, a power calculation for sample size indicated that 20 subjects would provide a 90% change of detecting an effect size of 0.83 (a change of 0.83 standard deviations)|
1655198|NCT01621802|3046575|Non-Inferiority or Equivalence (legacy)|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_I group divided by pooled Com_MMR_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.01|||||2-Sided|97.5|0.95|1.07|||||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.||
1655199|NCT01621802|3046575|Non-Inferiority or Equivalence (legacy)|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_CO group divided by pooled Com_MMR_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.03|||||2-Sided|97.5|0.97|1.09|||||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.|Adjusted geometric mean concentration (GMC) ratio (Inv_MMR_CO group divided by Com_MMR_CO group) for antibodies to rubella virus.|
1655200|NCT01621802|3046576|Non-Inferiority or Equivalence (legacy)|The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_I group divided by pooled Com_MMR_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.96|||||2-Sided|97.5|0.87|1.06|||||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.||
1655201|NCT01621802|3046576|Non-Inferiority or Equivalence (legacy)|The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_CO group divided by pooled Com_MMR_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.91|||||2-Sided|97.5|0.83|1.0|||||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.||
1655202|NCT01621802|3046577|Non-Inferiority or Equivalence (legacy)|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_I group divided by pooled Com_MMR_I group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|1.03|||||2-Sided|97.5|0.96|1.1|||||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.||
1655203|NCT01621802|3046577|Non-Inferiority or Equivalence (legacy)|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for the adjusted GMC ratio (Inv_MMR_CO group divided by pooled Com_MMR_CO group) was ≥ 0.67 for antibodies to measles, mumps and rubella viruses.|Adjusted GMC ratio|0.99|||||2-Sided|97.5|0.92|1.06|||||The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 97.5% confidence interval.||
1655204|NCT01621802|3046578|Non-Inferiority or Equivalence (legacy)|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_I group minus pooled Com_MMR_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||2-Sided|97.5|-0.68|1.75|||||Difference in percentage (Inv_MMR_I Group minus Com_MMR_I Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.|"Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."|
1655205|NCT01621802|3046578|Non-Inferiority or Equivalence (legacy)|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_CO group minus pooled Com_MMR_CO group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|-0.14|||||2-Sided|97.5|-0.98|1.84|||||Difference in percentage (Inv_MMR_CO Group minus Com_MMR_CO Group) in percentage of subjects with an anti-rubella antibody concentration ≥ 10 IU/mL.|"Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."|
1655206|NCT01621802|3046579|Non-Inferiority or Equivalence (legacy)|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_I group minus pooled Com_MMR_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in Seroresponse rate (%)|0.0|||||2-Sided|97.5|-0.68|1.75|||||Difference in percentage (Inv_MMR_I Group minus Com_MMR_I Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.|"Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."|
1655207|NCT01621802|3046579|Non-Inferiority or Equivalence (legacy)|Non-inferiority criterion for sub cohort 1: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_CO Group minus pooled Com_MMR_CO Group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||2-Sided|97.5|-0.72|1.97|||||Difference in percentage (Inv_MMR_CO Group minus Com_MMR_CO Group) in percentage of subjects with an anti-mumps antibody concentration ≥ 10 EU/mL.|"Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."|
1655241|NCT01620528|3046707|Superiority||Difference in LS Means|-3.23|Standard Error of the Mean|0.98||0.001|2-Sided|95.0|-5.16|-1.3|||ANCOVA||||
1655242|NCT01620528|3046707|Superiority||Difference in LS Means|-0.71|Standard Error of the Mean|0.97||0.462|2-Sided|95.0|-2.61|1.19|||ANCOVA||||
1655243|NCT01620528|3046708|Superiority||Difference in LS Means|-1.3|Standard Error of the Mean|0.36|<|0.001|2-Sided|95.0|-2.01|-0.59|||ANCOVA||||
1655208|NCT01621802|3046580|Non-Inferiority or Equivalence (legacy)|Non-inferiority criterion for sub cohort 2: The LL of the 2-sided 97.5% CI for group difference (Inv_MMR_I group minus pooled Com_MMR_I group) in seroresponse rates to measles, mumps and rubella viruses was ≥ -5%.|Difference in Seroresponse rate (%)|0.71|||||2-Sided|97.5|0.02|2.97|||||Difference in percentage (Inv_MMR_I Group minus Com_MMR_I Group) in percentage of subjects with an anti-Measles antibody concentration ≥ 200 mIU/mL.|"Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2."|
1655209|NCT01621802|3046580|Non-Inferiority or Equivalence (legacy)|Non-inferiority criterion for sub cohort 1: Lower limit (LL) of the 2-sided 97.5% confidence interval (CI) for group difference (Inv_MMR_CO Group minus pooled Com_MMR_CO Group) in seroresponse rates to measles, mumps and rubella viruses is ≥ -5%.|Difference in seroresponse rate (%)|0.0|||||2-Sided|97.5|-0.72|1.98|||||Difference in percentage (Inv_MMR_CO Group minus Com_MMR_CO Group) in percentage of subjects with an anti-measles antibody concentration ≥ 200 mIU/mL.|"Power obtained using PASS 2005 (Likelihood Score [Miettienen and Nurminen approach]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1."|
1655210|NCT01621776|3046581|Superiority or Other||Mean Difference (Final Values)|220.46|Standard Deviation|89.97||0.806|2-Sided|95.0|197.22|243.71|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.||
1655211|NCT01621776|3046582|Superiority or Other||Mean Difference (Final Values)|161.09|Standard Deviation|62.67||0.698|2-Sided|95.0|144.91|177.28|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.||
1655212|NCT01621776|3046583|Superiority or Other||Mean Difference (Final Values)|145.1|Standard Deviation|78.04||0.971||95.0|129.73|160.47|||ANOVA||This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.||
1655213|NCT01621542|3046606|Other|None specified||||||||||||||||The MTD could not be established for this study as no DLTs occurred at doses up to and including 27.0 mg|The MTD could not be established for this study as no DLTs occurred at doses up to and including 27.0 mg
1655214|NCT01621178|3046667|Non-Inferiority|Non-Inferiority to Glargine with a 0.4% margin|Mean Difference (Final Values)|0.02|||<|0.001|2-Sided|95.0|-0.18|0.22|||Mixed Models Analysis|||Week 26|
1655215|NCT01621178|3046667|Non-Inferiority|Non-Inferiority to Glargine with a 0.4% margin|Mean Difference (Final Values)|-0.05|||<|0.001|2-Sided|95.0|-0.26|0.15|||Mixed Models Analysis|||Week 26|
1655216|NCT01621009|3046669|Superiority or Other||Odds Ratio (OR)|1.13|||>|0.05|2-Sided|95.0|0.52|2.44|||Regression, Logistic||||
1655217|NCT01621009|3046669|Superiority or Other||Odds Ratio (OR)|1.61|||>|0.05|2-Sided|95.0|0.78|3.36|||Regression, Logistic||||
1655218|NCT01620593|3046687|Superiority|t-test|||||<|0.05|||||||t-test, 2 sided||||
1655219|NCT01620528|3046696|Superiority||Difference in LS Means|-3.75|Standard Error of the Mean|0.67|<|0.001|2-Sided|95.0|-5.06|-2.44|||ANCOVA||||
1655220|NCT01620528|3046696|Superiority||Difference in LS Means|-1.83|Standard Error of the Mean|0.66|<|0.006|2-Sided|95.0|-3.13|-0.54|||ANCOVA||||
1655221|NCT01620528|3046697|Superiority||Difference in LS Means|-2.83|Standard Error of the Mean|0.55|<|0.001|2-Sided|95.0|-3.91|-1.74|||ANCOVA||||
1655222|NCT01620528|3046697|Superiority||Difference in LS Means|-1.14|Standard Error of the Mean|0.55|<|0.038|2-Sided|95.0|-2.22|-0.07|||ANCOVA||||
1655223|NCT01620528|3046698|Superiority||Difference in LS Means|-3.24|Standard Error of the Mean|0.64|<|0.001|2-Sided|95.0|-4.5|-1.98|||ANCOVA||||
1655224|NCT01620528|3046698|Superiority||Difference in LS Means|-1.54|Standard Error of the Mean|0.64|<|0.017|2-Sided|95.0|-2.8|-0.27|||ANCOVA||||
1655225|NCT01620528|3046699|Superiority||Difference in LS Means|-3.0|Standard Error of the Mean|0.63|<|0.001|2-Sided|95.0|-4.23|-1.76|||ANCOVA||||
1655226|NCT01620528|3046699|Superiority||Difference in LS Means|-2.17|Standard Error of the Mean|0.62|<|0.001|2-Sided|95.0|-3.39|-0.95|||ANCOVA||||
1655227|NCT01620528|3046700|Superiority||Difference in LS Means|-2.65|Standard Error of the Mean|0.68|<|0.001|2-Sided|95.0|-3.98|-1.32|||ANCOVA||||
1655228|NCT01620528|3046700|Superiority||Difference in LS Means|-2.09|Standard Error of the Mean|0.67|<|0.002|2-Sided|95.0|-3.4|-0.78|||ANCOVA||||
1655229|NCT01620528|3046701|Superiority||Difference in LS Means|-2.6|Standard Error of the Mean|0.57|<|0.001|2-Sided|95.0|-3.71|-1.49|||ANCOVA||||
1655230|NCT01620528|3046701|Superiority||Difference in LS Means|-2.12|Standard Error of the Mean|0.57|<|0.001|2-Sided|95.0|-3.24|-1.01|||ANCOVA||||
1655231|NCT01620528|3046702|Superiority||Difference in LS Means|-6.79|Standard Error of the Mean|1.21|<|0.001|2-Sided|95.0|-9.17|-4.41|||ANCOVA||||
1655232|NCT01620528|3046702|Superiority||Difference in LS Means|-2.25|Standard Error of the Mean|1.16|<|0.053|2-Sided|95.0|-4.53|0.03|||ANCOVA||||
1655233|NCT01620528|3046703|Superiority||Difference in LS Means|-5.13|Standard Error of the Mean|0.98|<|0.001|2-Sided|95.0|-7.06|-3.2|||ANCOVA||||
1655234|NCT01620528|3046703|Superiority||Difference in LS Means|-1.17|Standard Error of the Mean|0.94|<|0.215|2-Sided|95.0|-3.02|0.68|||ANCOVA||||
1655235|NCT01620528|3046704|Superiority||Difference in LS Means|-5.25|Standard Error of the Mean|0.96|<|0.001|2-Sided|95.0|-7.14|-3.36|||ANCOVA||||
1655236|NCT01620528|3046704|Superiority||Difference in LS Means|-2.42|Standard Error of the Mean|0.94|<|0.01|2-Sided|95.0|-4.26|-0.58|||ANCOVA||||
1655237|NCT01620528|3046705|Superiority||Difference in LS Means|-4.91|Standard Error of the Mean|1.04|<|0.001|2-Sided|95.0|-6.95|-2.86|||ANCOVA||||
1655238|NCT01620528|3046705|Superiority||Difference in LS Means|-2.2|Standard Error of the Mean|1.03|<|0.032|2-Sided|95.0|-4.21|-0.18|||ANCOVA||||
1655239|NCT01620528|3046706|Superiority||Difference in LS Means|-4.86|Standard Error of the Mean|1.0|<|0.001|2-Sided|95.0|-6.82|-2.9|||ANCOVA||||
1655244|NCT01620528|3046708|Superiority||LS Mean of Difference|-0.59|Standard Error of the Mean|0.35|<|0.095|2-Sided|95.0|-1.28|0.1|||ANCOVA||||
1655245|NCT01620528|3046709|Superiority||Difference in LS Means|-1.04|Standard Error of the Mean|0.27|<|0.001|2-Sided|95.0|-1.57|-0.52|||ANCOVA||||
1655246|NCT01620528|3046709|Superiority||Difference in LS Means|-0.2|Standard Error of the Mean|0.27|<|0.46|2-Sided|95.0|-0.72|0.32|||ANCOVA||||
1655247|NCT01620528|3046710|Superiority||Difference in LS Means|-1.05|Standard Error of the Mean|0.36||0.003|2-Sided|95.0|-1.75|-0.35|||ANCOVA||||
1655248|NCT01620528|3046710|Superiority||Difference in LS Means|-0.31|Standard Error of the Mean|0.36||0.39|2-Sided|95.0|-1.01|0.4|||ANCOVA||||
1655249|NCT01620528|3046711|Superiority||Difference in LS Means|-0.98|Standard Error of the Mean|0.34||0.003|2-Sided|95.0|-1.64|-0.32|||ANCOVA||||
1655250|NCT01620528|3046711|Superiority||Difference in LS Means|-0.54|Standard Error of the Mean|0.33||0.103|2-Sided|95.0|-1.19|0.11|||ANCOVA||||
1655251|NCT01620528|3046712|Superiority||Difference in LS Means|-1.06|Standard Error of the Mean|0.38||0.006|2-Sided|95.0|-1.81|-0.31|||ANCOVA||||
1655252|NCT01620528|3046712|Superiority||Difference in LS Means|-0.76|Standard Error of the Mean|0.38||0.045|2-Sided|95.0|-1.49|-0.02|||mixed-effects model||||
1655253|NCT01620528|3046713|Superiority||Difference in LS Means|-1.05|Standard Error of the Mean|0.36||0.004|2-Sided|95.0|-1.76|-0.34|||ANCOVA||||
1655254|NCT01620528|3046713|Superiority||Difference in LS Means|-1.19|Standard Error of the Mean|0.36||0.001|2-Sided|95.0|-1.9|-0.48|||ANCOVA||||
1655255|NCT01620528|3046714|Superiority||Difference in LS Means|-4.47|Standard Error of the Mean|0.88|<|0.001|2-Sided|95.0|-6.19|-2.74|||ANCOVA||||
1655256|NCT01620528|3046714|Superiority||Difference in LS Means|-1.36|Standard Error of the Mean|0.85|<|0.108|2-Sided|95.0|-3.02|0.3|||ANCOVA||||
1655257|NCT01620528|3046715|Superiority||Difference in LS Means|-3.13|Standard Error of the Mean|0.8|<|0.001|2-Sided|95.0|-4.7|-1.56|||ANCOVA||||
1655258|NCT01620528|3046715|Superiority||Difference in LS Means|-0.51|Standard Error of the Mean|0.76|<|0.502|2-Sided|95.0|-2.0|0.98|||ANCOVA||||
1655259|NCT01620528|3046716|Superiority||Difference in LS Means|-3.89|Standard Error of the Mean|0.74|<|0.001|2-Sided|95.0|-5.34|-2.43|||ANCOVA||||
1655260|NCT01620528|3046716|Superiority||Difference in LS Means|-1.6|Standard Error of the Mean|0.72|<|0.026|2-Sided|95.0|-3.01|-0.19|||ANCOVA||||
1655261|NCT01620528|3046717|Superiority||Difference in LS Means|-2.93|Standard Error of the Mean|0.84|<|0.001|2-Sided|95.0|-4.59|-1.28|||ANCOVA||||
1655262|NCT01620528|3046717|Superiority||Difference in LS Means|-1.01|Standard Error of the Mean|0.82|<|0.219|2-Sided|95.0|-2.63|0.6|||ANCOVA||||
1655263|NCT01620528|3046718|Superiority||Difference in LS Means|-3.52|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-5.28|-1.75|||ANCOVA||||
1655264|NCT01620528|3046718|Superiority||Difference in LS Means|-1.41|Standard Error of the Mean|0.88|<|0.107|2-Sided|95.0|-3.13|0.31|||ANCOVA||||
1655265|NCT01620528|3046719|Superiority||Difference in LS Means|-1.93|Standard Error of the Mean|0.89||0.031|2-Sided|95.0|-3.67|-0.18|||ANCOVA||||
1655266|NCT01620528|3046719|Superiority||Difference in LS Means|-0.86|Standard Error of the Mean|0.87||0.326|2-Sided|95.0|-2.57|0.85|||ANCOVA||||
1655267|NCT01620528|3046720|Superiority||Difference in LS Means|-2.49|Standard Error of the Mean|0.48|<|0.001|2-Sided|95.0|-3.44|-1.54|||ANCOVA||||
1655268|NCT01620528|3046720|Superiority||Difference in LS Means|-1.28|Standard Error of the Mean|0.48|<|0.007|2-Sided|95.0|-2.22|-0.34|||ANCOVA||||
1655269|NCT01620528|3046721|Superiority||Difference in LS Means|-1.81|Standard Error of the Mean|0.39|<|0.001|2-Sided|95.0|-2.58|-1.04|||ANCOVA||||
1655270|NCT01620528|3046721|Superiority||Difference in LS Means|-0.97|Standard Error of the Mean|0.39|<|0.013|2-Sided|95.0|-1.74|-0.2|||ANCOVA||||
1655271|NCT01620528|3046722|Superiority||Difference in LS Means|-2.23|Standard Error of the Mean|0.42|<|0.001|2-Sided|95.0|-3.06|-1.4|||ANCOVA||||
1655272|NCT01620528|3046722|Superiority||Difference in LS Means|-1.21|Standard Error of the Mean|0.42|<|0.004|2-Sided|95.0|-2.05|-0.38|||ANCOVA||||
1655273|NCT01620528|3046723|Superiority||Difference in LS Means|-2.1|Standard Error of the Mean|0.47|<|0.001|2-Sided|95.0|-3.02|-1.19|||ANCOVA||||
1655274|NCT01620528|3046723|Superiority||Difference in LS Means|-1.63|Standard Error of the Mean|0.46|<|0.001|2-Sided|95.0|-2.53|-0.72|||ANCOVA||||
1655275|NCT01620528|3046724|Superiority||Difference in LS Means|-1.64|Standard Error of the Mean|0.47|<|0.001|2-Sided|95.0|-2.56|-0.71|||ANCOVA||||
1655276|NCT01620528|3046724|Superiority||Difference in LS Means|-1.33|Standard Error of the Mean|0.47|<|0.005|2-Sided|95.0|-2.24|-0.41|||ANCOVA||||
1655277|NCT01620528|3046725|Superiority||Difference in LS Means|-1.62|Standard Error of the Mean|0.37|<|0.001|2-Sided|95.0|-2.35|-0.9|||ANCOVA||||
1655278|NCT01620528|3046725|Superiority||Difference in LS Means|-0.92|Standard Error of the Mean|0.37|<|0.013|2-Sided|95.0|-1.65|-0.2|||ANCOVA||||
1655279|NCT01620528|3046726|Superiority||Difference in LS Means|-2.21|Standard Error of the Mean|0.65|<|0.001|2-Sided|95.0|-3.48|-0.93|||ANCOVA||||
1655280|NCT01620528|3046726|Superiority||Difference in LS Means|-0.75|Standard Error of the Mean|0.62|<|0.232|2-Sided|95.0|-1.97|0.48|||ANCOVA||||
1655281|NCT01620528|3046727|Superiority||Difference in LS Means|-1.85|Standard Error of the Mean|0.42|<|0.001|2-Sided|95.0|-2.67|-1.02|||ANCOVA||||
1655282|NCT01620528|3046727|Superiority||Difference in LS Means|-0.65|Standard Error of the Mean|0.4|<|0.106|2-Sided|95.0|-1.44|0.14|||ANCOVA||||
1655283|NCT01620528|3046728|Superiority||Difference in LS Means|-1.37|Standard Error of the Mean|0.45||0.003|2-Sided|95.0|-2.25|-0.48|||ANCOVA||||
1655284|NCT01620528|3046728|Superiority||Difference in LS Means|-0.77|Standard Error of the Mean|0.44||0.08|2-Sided|95.0|-1.63|0.09|||ANCOVA||||
1655285|NCT01620528|3046729|Superiority||Difference in LS Means|-1.78|Standard Error of the Mean|0.44|<|0.001|2-Sided|95.0|-2.65|-0.91|||ANCOVA||||
1655286|NCT01620528|3046729|Superiority||LS Mean of Difference|-1.05|Standard Error of the Mean|0.43|<|0.016|2-Sided|95.0|-1.9|-0.19|||ANCOVA||||
1655287|NCT01620528|3046730|Superiority||Difference in LS Means|-1.27|Standard Error of the Mean|0.36|<|0.001|2-Sided|95.0|-1.97|-0.57|||ANCOVA||||
1655288|NCT01620528|3046730|Superiority||Difference in LS Means|-0.47|Standard Error of the Mean|0.35|<|0.172|2-Sided|95.0|-1.16|0.21|||ANCOVA||||
1655289|NCT01620528|3046731|Superiority||Difference in LS Means|-1.16|Standard Error of the Mean|0.38||0.002|2-Sided|95.0|-1.9|-0.42|||ANCOVA||||
1655290|NCT01620528|3046731|Superiority||Difference in LS Means|0.12|Standard Error of the Mean|0.37||0.741|2-Sided|95.0|-0.61|0.85|||ANCOVA||||
1655291|NCT01620528|3046732|Superiority||Difference in LS Means|-17.51|Standard Error of the Mean|3.06|<|0.001|2-Sided|95.0|-23.52|-11.5|||ANCOVA||||
1655292|NCT01620528|3046732|Superiority||Difference in LS Means|-4.71|Standard Error of the Mean|2.91|<|0.107|2-Sided|95.0|-10.43|1.02|||ANCOVA||||
1655293|NCT01620528|3046733|Superiority||Difference in LS Means|-13.86|Standard Error of the Mean|2.56|<|0.001|2-Sided|95.0|-18.89|-8.84|||ANCOVA||||
1655294|NCT01620528|3046733|Superiority||Difference in LS Means|-4.74|Standard Error of the Mean|2.39|<|0.047|2-Sided|95.0|-9.43|-0.05|||ANCOVA||||
1655295|NCT01620528|3046734|Superiority||Difference in LS Means|-5.04|Standard Error of the Mean|2.03||0.013|2-Sided|95.0|-9.04|-1.05|||ANCOVA||||
1655296|NCT01620528|3046734|Superiority||LS Mean of Difference|-0.78|Standard Error of the Mean|1.94||0.685|2-Sided|95.0|-4.59|3.02|||ANCOVA||||
1655297|NCT01620528|3046735|Superiority||Difference in LS Means|-25.1|Standard Error of the Mean|2.04|<|0.001|2-Sided|95.0|-29.12|-21.09|||ANCOVA||||
1655298|NCT01620528|3046735|Superiority||Difference in LS Means|-12.57|Standard Error of the Mean|1.99|<|0.001|2-Sided|95.0|-16.48|-8.66|||ANCOVA||||
1655299|NCT01620528|3046736|Superiority||Difference in LS Means|-18.75|Standard Error of the Mean|1.77|<|0.001|2-Sided|95.0|-22.22|-15.27|||ANCOVA||||
1655300|NCT01620528|3046736|Superiority||Difference in LS Means|-9.28|Standard Error of the Mean|1.72|<|0.001|2-Sided|95.0|-12.66|-5.91|||ANCOVA||||
1655301|NCT01620528|3046737|Superiority||Difference in LS Means|-9.76|Standard Error of the Mean|1.6|<|0.001|2-Sided|95.0|-12.91|-6.61|||ANCOVA||||
1655302|NCT01620528|3046737|Superiority||Difference in LS Means|-6.29|Standard Error of the Mean|1.57|<|0.001|2-Sided|95.0|-9.37|-3.21|||ANCOVA||||
1655303|NCT01620528|3046738|Superiority||LS Mean of Difference|-1.6|Standard Error of the Mean|0.179|<|0.001|2-Sided|97.5|-2.0|-1.2|||mixed-effects model||||
1655304|NCT01620528|3046738|Superiority||LS Mean of Difference|-0.65|Standard Error of the Mean|0.176|<|0.001|2-Sided|97.5|-1.04|-0.25|||mixed-effects model||||
1655305|NCT01620528|3046739|Superiority||LS Mean of Difference|-1.61|Standard Error of the Mean|0.17|<|0.001|2-Sided|97.5|-1.99|-1.23|||mixed-effects model||||
1655306|NCT01620528|3046739|Superiority||LS Mean of Difference|-0.68|Standard Error of the Mean|0.167|<|0.001|2-Sided|97.5|-1.05|-0.3|||mixed-effects model||||
1655307|NCT01620528|3046740|Superiority||LS Mean of Difference|-1.61|Standard Error of the Mean|0.165|<|0.001|2-Sided|97.5|-1.98|-1.24|||mixed-effects model||||
1655308|NCT01620528|3046740|Superiority||LS Mean of Difference|-0.8|Standard Error of the Mean|0.163|<|0.001|2-Sided|97.5|-1.17|-0.44|||mixed-effects model||||
1655309|NCT01620528|3046741|Superiority||LS Mean of Difference|-0.96|Standard Error of the Mean|0.138||-0.96|2-Sided|97.5|-1.27|-0.65|||mixed-effects model||||
1655310|NCT01620528|3046741|Superiority||LS Mean of Difference|-0.47|Standard Error of the Mean|0.137|<|0.001|2-Sided|97.5|-0.77|-0.16|||mixed-effects model||||
1655311|NCT01620528|3046742|Superiority||LS Mean of Difference|-0.4|Standard Error of the Mean|0.11|<|0.001|2-Sided|97.5|-0.65|-0.16|||mixed-effects model||||
1655312|NCT01620528|3046742|Superiority||LS Mean of Difference|-0.28|Standard Error of the Mean|0.109|<|0.011|2-Sided|95.0|-0.52|-0.03|||mixed-effects model||||
1655313|NCT01620528|3046743|Superiority||LS Mean of Difference|-1.35|Standard Error of the Mean|0.123|<|0.001|2-Sided|95.0|-1.59|-1.11|||ANOVA||||
1655314|NCT01620528|3046743|Superiority||LS Mean of Difference|-0.72|Standard Error of the Mean|0.122|<|0.001|2-Sided|95.0|-0.96|-0.48|||ANOVA||||
1655315|NCT01620528|3046744|Superiority||LS Mean of Difference|-1.32|Standard Error of the Mean|0.112|<|0.001|2-Sided|95.0|-1.54|-1.1|||ANOVA||||
1655316|NCT01620528|3046744|Superiority||LS Mean of Difference|-0.69|Standard Error of the Mean|0.111|<|0.001|2-Sided|95.0|-0.91|-0.48|||ANOVA||||
1655317|NCT01620528|3046745|Superiority||LS Mean of Difference|-1.26|Standard Error of the Mean|0.107|<|0.001|2-Sided|95.0|-1.47|-1.05|||ANOVA||||
1655318|NCT01620528|3046745|Superiority||LS Mean of Difference|-0.63|Standard Error of the Mean|0.106|<|0.001|2-Sided|95.0|-0.83|-0.42|||ANOVA||||
1655319|NCT01620528|3046746|Superiority||LS Mean of Difference|-1.12|Standard Error of the Mean|0.102|<|0.001|2-Sided|95.0|-1.32|-0.92|||ANOVA||||
1655320|NCT01620528|3046746|Superiority||LS Mean of Difference|-0.61|Standard Error of the Mean|0.101|<|0.001|2-Sided|95.0|-0.81|-0.41|||ANOVA||||
1655321|NCT01620528|3046747|Superiority||LS Mean of Difference|-1.02|Standard Error of the Mean|0.099|<|0.001|2-Sided|95.0|-1.21|-0.82|||ANOVA||||
1655322|NCT01620528|3046747|Superiority||LS Mean of Difference|-0.39|Standard Error of the Mean|0.098|<|0.001|2-Sided|95.0|-0.58|-0.19|||ANOVA||||
1655323|NCT01620528|3046748|Superiority||LS Mean of Difference|-0.74|Standard Error of the Mean|0.095|<|0.001|2-Sided|95.0|-0.93|-0.56|||ANOVA||||
1655324|NCT01620528|3046748|Superiority||LS Mean of Difference|-0.53|Standard Error of the Mean|0.094|<|0.001|2-Sided|95.0|-0.72|-0.34|||ANOVA||||
1655325|NCT01620528|3046749|Superiority||LS Mean of Difference|-0.3|Standard Error of the Mean|0.054|<|0.001|2-Sided|97.5|-0.42|-0.18|||mixed-effects model||||
1655326|NCT01620528|3046749|Superiority||LS Mean of Difference|-0.07|Standard Error of the Mean|0.053|<|0.2|2-Sided|97.5|-0.19|0.05|||mixed-effects model||||
1655327|NCT01620528|3046750|Superiority||LS Mean of Difference|-0.29|Standard Error of the Mean|0.053|<|0.001|2-Sided|97.5|-0.41|-0.17|||mixed-effects model||||
1655328|NCT01620528|3046750|Superiority||LS Mean of Difference|-0.11|Standard Error of the Mean|0.053|<|0.037|2-Sided|97.5|-0.23|0.01|||mixed-effects model||||
1655329|NCT01620528|3046751|Superiority||LS Mean of Difference|-0.22|Standard Error of the Mean|0.047|<|0.001|2-Sided|97.5|-0.32|-0.11|||mixed-effects model||||
1655330|NCT01620528|3046751|Superiority||LS Mean of Difference|-0.03|Standard Error of the Mean|0.047|<|0.519|2-Sided|97.5|-0.13|0.07|||mixed-effects model||||
1655331|NCT01620528|3046752|Superiority||LS Mean of Difference|-0.12|Standard Error of the Mean|0.044||0.006|2-Sided|97.5|-0.22|-0.02|||mixed-effects model||||
1655332|NCT01620528|3046752|Superiority||LS Mean of Difference|-0.04|Standard Error of the Mean|0.044||0.313|2-Sided|97.5|-0.14|0.05|||mixed-effects model||||
1655573|NCT01619410|3046870|Superiority|||||||1|||||||Fisher Exact||||
1655333|NCT01620528|3046753|Superiority||LS Mean of Difference|-0.3|Standard Error of the Mean|0.078|<|0.001|2-Sided|97.5|-0.48|-0.13|||mixed-effects model||||
1655334|NCT01620528|3046753|Superiority||LS Mean of Difference|-0.12|Standard Error of the Mean|0.074|<|0.118|2-Sided|97.5|-0.28|0.05|||mixed-effects model||||
1655335|NCT01620528|3046754|Superiority||LS Mean of Difference|-0.27|Standard Error of the Mean|0.076|<|0.001|2-Sided|97.5|-0.44|-0.1|||mixed-effects model||||
1655336|NCT01620528|3046754|Superiority||LS Mean of Difference|-0.14|Standard Error of the Mean|0.073|<|0.06|2-Sided|97.5|-0.3|0.03|||mixed-effects model||||
1655337|NCT01620528|3046755|Superiority||LS Mean of Difference|-0.34|Standard Error of the Mean|0.071|<|0.001|2-Sided|97.5|-0.5|-0.18|||mixed-effects model||||
1655338|NCT01620528|3046755|Superiority||LS Mean of Difference|-0.18|Standard Error of the Mean|0.069|<|0.009|2-Sided|97.5|-0.34|-0.03|||mixed-effects model||||
1655339|NCT01620528|3046756|Superiority||LS Mean of Difference|-0.12|Standard Error of the Mean|0.061||0.058|2-Sided|97.5|-0.25|0.02|||mixed-effects model||||
1655340|NCT01620528|3046756|Superiority||LS Mean of Difference|-0.07|Standard Error of the Mean|0.06||0.252|2-Sided|97.5|-0.2|0.07|||mixed-effects model||||
1655341|NCT01620528|3046757|Superiority||LS Mean of Difference|-0.04|Standard Error of the Mean|0.053||0.488|2-Sided|97.5|-0.16|0.08|||mixed-effects model||||
1655342|NCT01620528|3046757|Superiority||LS Mean of Difference|-0.11|Standard Error of the Mean|0.052||0.038|2-Sided|97.5|-0.22|0.01|||mixed-effects model||||
1655343|NCT01620528|3046758|Superiority||LS Mean of Difference|-29.97|Standard Error of the Mean|3.868|<|0.001|2-Sided|97.5|-38.66|-21.28|||mixed-effects model||||
1655344|NCT01620528|3046758|Superiority||LS Mean of Difference|-12.37|Standard Error of the Mean|3.805|<|0.001|2-Sided|97.5|-20.92|-3.83|||mixed-effects model||||
1655345|NCT01620528|3046759|Superiority||LS Mean of Difference|-29.68|Standard Error of the Mean|3.788|<|0.001|2-Sided|97.5|-38.19|-21.18|||mixed-effects model||||
1655346|NCT01620528|3046759|Superiority||LS Mean of Difference|-11.55|Standard Error of the Mean|3.736|<|0.002|2-Sided|97.5|-19.94|-3.16|||mixed-effects model||||
1655347|NCT01620528|3046760|Superiority||LS Mean of Difference|-30.41|Standard Error of the Mean|3.729|<|0.001|2-Sided|97.5|-38.78|-22.04|||mixed-effects model||||
1655348|NCT01620528|3046760|Superiority||LS Mean of Difference|-14.11|Standard Error of the Mean|3.673|<|0.001|2-Sided|97.5|-22.36|-5.87|||mixed-effects model||||
1655349|NCT01620528|3046761|Superiority||LS Mean of Difference|-22.49|Standard Error of the Mean|3.514|<|0.001|2-Sided|97.5|-30.38|-14.6|||mixed-effects model||||
1655350|NCT01620528|3046761|Superiority||LS Mean of Difference|-8.47|Standard Error of the Mean|3.475|<|0.015|2-Sided|97.5|-16.27|-0.66|||mixed-effects model||||
1655351|NCT01620528|3046762|Superiority||LS Mean of Difference|-13.72|Standard Error of the Mean|3.249|<|0.001|2-Sided|97.5|-21.01|-6.42|||mixed-effects model||||
1655352|NCT01620528|3046762|Superiority||LS Mean of Difference|-5.69|Standard Error of the Mean|3.226|<|0.078|2-Sided|97.5|-12.93|1.56|||mixed-effects model||||
1655353|NCT01620528|3046763|Superiority||LS Mean of Difference|-7.72|Standard Error of the Mean|2.756||0.005|2-Sided|97.5|-13.9|-1.53|||mixed-effects model||||
1655354|NCT01620528|3046763|Superiority||LS Mean of Difference|-6.23|Standard Error of the Mean|2.748||0.024|2-Sided|97.5|-12.4|-0.06|||mixed-effects model||||
1655355|NCT01620528|3046764|Superiority||LS Mean of Difference|-0.39|Standard Error of the Mean|0.054|<|0.001|2-Sided|97.5|-0.52|-0.27|||mixed-effects model||||
1655356|NCT01620528|3046764|Superiority||LS Mean of Difference|-0.15|Standard Error of the Mean|0.053|<|0.004|2-Sided|97.5|-0.27|-0.03|||mixed-effects model||||
1655357|NCT01620528|3046765|Superiority||LS Mean of Difference|-0.39|Standard Error of the Mean|0.054|<|0.001|2-Sided|97.5|-0.51|-0.27|||mixed-effects model||||
1655358|NCT01620528|3046765|Superiority||LS Mean of Difference|-0.19|Standard Error of the Mean|0.053|<|0.001|2-Sided|97.5|-0.31|-0.07|||mixed-effects model||||
1655359|NCT01620528|3046766|Superiority||LS Mean of Difference|-0.29|Standard Error of the Mean|0.05|<|0.001|2-Sided|97.5|-0.41|-0.18|||mixed-effects model||||
1655360|NCT01620528|3046766|Superiority||LS Mean of Difference|-0.12|Standard Error of the Mean|0.05|<|0.017|2-Sided|97.5|-0.23|-0.01|||mixed-effects model||||
1655361|NCT01620528|3046767|Superiority||LS Mean of Difference|-0.18|Standard Error of the Mean|0.045|<|0.001|2-Sided|97.5|-0.28|-0.08|||mixed-effects model||||
1655362|NCT01620528|3046767|Superiority||LS Mean of Difference|-0.08|Standard Error of the Mean|0.045|<|0.092|2-Sided|97.5|-0.18|0.02|||mixed-effects model||||
1655363|NCT01620528|3046768|Superiority||LS Mean of Difference|-0.1|Standard Error of the Mean|0.036||0.008|2-Sided|97.5|-0.18|-0.01|||mixed-effects model||||
1655364|NCT01620528|3046768|Superiority||LS Mean of Difference|-0.06|Standard Error of the Mean|0.036||0.111|2-Sided|97.5|-0.14|0.02|||mixed-effects model||||
1655365|NCT01620528|3046769|Superiority||LS Mean of Difference|-60.78|Standard Error of the Mean|3.557|<|0.001|2-Sided|97.5|-68.77|-52.79|||mixed-effects model||||
1655366|NCT01620528|3046769|Superiority||LS Mean of Difference|-21.39|Standard Error of the Mean|3.479|<|0.001|2-Sided|97.5|-29.2|-13.57|||mixed-effects model||||
1655367|NCT01620528|3046770|Superiority||LS Mean of Difference|-66.5|Standard Error of the Mean|3.321|<|0.001|2-Sided|97.5|-73.95|-59.04|||mixed-effects model||||
1655368|NCT01620528|3046770|Superiority||LS Mean of Difference|-28.63|Standard Error of the Mean|3.26|<|0.001|2-Sided|97.5|-35.96|-21.31|||mixed-effects model||||
1655369|NCT01620528|3046771|Superiority||LS Mean of Difference|-61.9|Standard Error of the Mean|3.356|<|0.001|2-Sided|97.5|-69.44|-54.36|||mixed-effects model||||
1655370|NCT01620528|3046771|Superiority||LS Mean of Difference|-29.94|Standard Error of the Mean|3.272|<|0.001|2-Sided|97.5|-37.28|-22.59|||mixed-effects model||||
1655371|NCT01620528|3046772|Superiority||LS Mean of Difference|-64.94|Standard Error of the Mean|3.23|<|0.001|2-Sided|97.5|-72.19|-57.68|||mixed-effects model||||
1655372|NCT01620528|3046772|Superiority||LS Mean of Difference|-32.21|Standard Error of the Mean|3.177|<|0.001|2-Sided|97.5|-39.35|-25.08|||mixed-effects model||||
1655373|NCT01620528|3046773|Superiority||LS Mean of Difference|-63.78|Standard Error of the Mean|3.148|<|0.001|2-Sided|97.5|-70.85|-56.71|||mixed-effects model||||
1655374|NCT01620528|3046773|Superiority||LS Mean of Difference|-30.79|Standard Error of the Mean|3.107|<|-30.79|2-Sided|97.5|-37.77|-23.82|||mixed-effects model||||
1655375|NCT01620528|3046774|Superiority||LS Mean of Difference|-31.01|Standard Error of the Mean|3.299|<|0.001|2-Sided|97.5|-38.41|-23.6|||mixed-effects model||||
1655376|NCT01620528|3046774|Superiority||LS Mean of Difference|-24.07|Standard Error of the Mean|3.288|<|0.001|2-Sided|97.5|-31.45|-16.69|||mixed-effects model||||
1655377|NCT01620528|3046775|Superiority||LS Mean of Difference|-1.41|Standard Error of the Mean|0.072|<|0.001|2-Sided|97.5|-1.58|-1.25|||mixed-effects model||||
1655378|NCT01620528|3046775|Superiority||LS Mean of Difference|-0.59|Standard Error of the Mean|0.071|<|0.001|2-Sided|97.5|-0.75|-0.43|||mixed-effects model||||
1655379|NCT01620528|3046776|Superiority||LS Mean of Difference|-1.32|Standard Error of the Mean|0.072|<|0.001|2-Sided|97.5|-1.49|-1.16|||mixed-effects model||||
1655380|NCT01620528|3046776|Superiority||LS Mean of Difference|-0.65|Standard Error of the Mean|0.071|<|0.001|2-Sided|97.5|-0.81|-0.49|||mixed-effects model||||
1655381|NCT01620528|3046777|Superiority||LS Mean of Difference|-1.39|Standard Error of the Mean|0.069|<|0.001|2-Sided|97.5|-1.54|-1.23|||mixed-effects model||||
1655382|NCT01620528|3046777|Superiority||LS Mean of Difference|-0.68|Standard Error of the Mean|0.068|<|0.001|2-Sided|97.5|-0.83|-0.53|||mixed-effects model||||
1655383|NCT01620528|3046778|Superiority||LS Mean of Difference|-1.36|Standard Error of the Mean|0.068|<|0.001|2-Sided|97.5|-1.51|-1.2|||mixed-effects model||||
1655384|NCT01620528|3046778|Superiority||LS Mean of Difference|-0.64|Standard Error of the Mean|0.067|<|0.001|2-Sided|97.5|-0.79|-0.49|||mixed-effects model||||
1655385|NCT01620528|3046779|Superiority||LS Mean of Difference|-0.65|Standard Error of the Mean|0.07|<|0.001|2-Sided|97.5|-0.81|-0.49|||mixed-effects model||||
1655386|NCT01620528|3046779|Superiority||LS Mean of Difference|-0.5|Standard Error of the Mean|0.07|<|0.001|2-Sided|97.5|-0.65|-0.34|||mixed-effects model||||
1655387|NCT01620528|3046780|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655388|NCT01620528|3046780|Superiority||||||<|0.126|||||||Regression, Logistic||||
1655389|NCT01620528|3046781|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655390|NCT01620528|3046781|Superiority||||||<|0.061|||||||Regression, Logistic||||
1655391|NCT01620528|3046782|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655392|NCT01620528|3046782|Superiority||||||<|0.01|||||||Regression, Logistic||||
1655393|NCT01620528|3046783|Superiority|||||||0.012|||||||Regression, Logistic||||
1655394|NCT01620528|3046783|Superiority|||||||0.855|||||||Regression, Logistic||||
1655395|NCT01620528|3046784|Superiority|||||||0.239|||||||Regression, Logistic||||
1655396|NCT01620528|3046784|Superiority|||||||0.306|||||||Regression, Logistic||||
1655397|NCT01620528|3046785|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655398|NCT01620528|3046785|Superiority||||||<|0.008|||||||Regression, Logistic||||
1655399|NCT01620528|3046786|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655400|NCT01620528|3046786|Superiority||||||<|0.005|||||||Regression, Logistic||||
1655401|NCT01620528|3046787|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655402|NCT01620528|3046787|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655403|NCT01620528|3046788|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655404|NCT01620528|3046788|Superiority||||||<|0.031|||||||Regression, Logistic||||
1655405|NCT01620528|3046789|Superiority|||||||0.023|||||||Regression, Logistic||||
1655406|NCT01620528|3046789|Superiority|||||||0.103|||||||Regression, Logistic||||
1655407|NCT01620528|3046790|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655408|NCT01620528|3046790|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655409|NCT01620528|3046791|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655410|NCT01620528|3046791|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655411|NCT01620528|3046792|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655412|NCT01620528|3046792|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655413|NCT01620528|3046793|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655414|NCT01620528|3046793|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655415|NCT01620528|3046794|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655416|NCT01620528|3046794|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655417|NCT01620528|3046795|Superiority||Difference in LS Mean Change|-0.12|Standard Error of the Mean|0.038||0.002|2-Sided||||||mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.|
1655418|NCT01620528|3046795|Superiority||Difference in LS Mean Change|0.03|Standard Error of the Mean|0.037||0.424|2-Sided||||||mixed-effects model|||Ranked secondary efficacy endpoint 7 of 7.|
1655419|NCT01620528|3046796|Superiority||Difference in LS Mean Change|-0.2|Standard Error of the Mean|0.067||0.003|2-Sided||||||mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.|
1655420|NCT01620528|3046796|Superiority||Difference in LS Mean Change|-0.09|Standard Error of the Mean|0.065||0.144|2-Sided||||||mixed-effects model|||Ranked secondary efficacy endpoint 6 of 7.|
1655421|NCT01620528|3046797|Superiority||Least Squares Mean Difference|-0.28|Standard Error of the Mean|0.057|<|0.001|2-Sided||||||mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.|
1655422|NCT01620528|3046797|Superiority||Difference in LS Mean Change|-0.07|Standard Error of the Mean|0.056|<|0.185|2-Sided||||||mixed-effects model|||Ranked secondary efficacy endpoint 5 of 7.|
1655423|NCT01620528|3046798|Superiority||Difference in LS Mean Change|-0.26|Standard Error of the Mean|0.051|<|0.001|2-Sided||||||mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.|
1655424|NCT01620528|3046798|Superiority||Difference in LS Mean Change|-0.01|Standard Error of the Mean|0.051|<|0.91|2-Sided||||||mixed-effects model|||Ranked secondary efficacy endpoint 4 of 7.|
1655425|NCT01620528|3046799|Superiority||Least Squares Mean Difference|-0.41|Standard Error of the Mean|0.057|<|0.001|2-Sided||||||mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.|
1655426|NCT01620528|3046799|Superiority||Difference in LS Mean Change|-0.16|Standard Error of the Mean|0.056|<|0.004|2-Sided||||||mixed-effects model|||Ranked secondary efficacy endpoint 3 of 7.|
1657005|NCT01597245|3049338|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1655427|NCT01620528|3046800|Superiority||Difference in Least Squares Mean|-1.32|Standard Error of the Mean|0.076|<|0.001|2-Sided||||||mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.|
1655428|NCT01620528|3046800|Superiority||Difference in LS Mean Change|-0.45|Standard Error of the Mean|0.074|<|0.001|2-Sided|95.0|||||mixed-effects model|||Ranked secondary efficacy endpoint 2 of 7.|
1655429|NCT01620528|3046801|Superiority||Difference in LS Mean Change|-1.3|Standard Error of the Mean|0.156|<|0.001|2-Sided||||||mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.|
1655430|NCT01620528|3046801|Superiority||Difference in LS Mean Change|-0.65|Standard Error of the Mean|0.155|<|0.001|2-Sided||||||mixed-effects model|||Ranked secondary efficacy endpoint 1 of 7.|
1655431|NCT01620528|3046802|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655432|NCT01620528|3046802|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655433|NCT01620528|3046803|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655434|NCT01620528|3046803|Superiority||||||<|0.001|||||||Regression, Logistic||||
1655435|NCT01620489|3046804|Superiority or Other||Estimated treatment ratio|0.98|||=|0||95.0|0.94|1.02||Not adjusted for multiple comparisons|Mixed Models Analysis|||The ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 weeks treatment was estimated based on log-transformed data for changes from baseline. The responses were analysed using an MMRM model with treatment, country and stratification groups as fixed effects and log-transformed baseline as a covariate, all nested within visit. The resulting estimates were back-transformed to the original scale.|
1655436|NCT01620489|3046805|Superiority or Other||Estimated treatment difference|-0.51|||=|0||95.0|-0.83|-0.18|||Mixed Models Analysis|Not adjusted for multiple comparisons||Change from baseline in BMI (kg/m˄2) after 26 weeks treatment was analysed separately using an MMRM analysis model with treatment, country and stratification groups as fixed effects and baseline as a covariate, all nested within visit.|
1655437|NCT01620489|3046806|Superiority or Other||Estimated treatment difference|-1.08|||<|0.0001||95.0|-1.58|-0.58||Not adjusted for multiple comparisons|Mixed Models Analysis|||Mean change from baseline in the 7-point profile (SMPG) after 26 weeks treatment was analysed using an MMRM model with treatment, country and stratification groups as fixed effects and baseline as a covariate, all nested within visit.|
1655438|NCT01620489|3046807|Superiority or Other||Estimated odds ratio|3.94|||<|0.0001||95.0|2.12|7.3||Not adjusted for multiple comparisons|Regression, Logistic|||Analysed by a logistic regression model with treatment, country and stratification groups as fixed effects and HbA1c at baseline as covariates.|
1655439|NCT01620489|3046808|Superiority or Other||Estimated odds ratio|4.48|||<|0.0001||95.0|2.46|8.18||Not adjusted for multiple comparisons|Regression, Logistic|||Analysed by a logistic regression model with treatment, country and stratification groups as fixed effects and HbA1c and body weight at baseline as covariates. No weight gain was defined as change from baseline to Week 26 in body weight ≤0 kg.|
1655440|NCT01620489|3046809|Superiority or Other||Estimated treatment difference|-0.66|||<|0.0001||95.0|-0.9|-0.43||Adjustment for multiple comparisons was not used since there was only one primary endpoint.|Mixed Models Analysis|||The null hypothesis of no treatment difference was tested using a two-sided test based on a mixed model repeated measurement (MMRM) analysis. The model included treatment, country, stratification groups (6 groups from cross-classifying renal function category (2 levels: eGFR<45 and ≥45 mL/min) and the background insulin treatment category (3 levels: basal, premix or no insulin)) as fixed effects factors and baseline HbA1c as a covariate, all nested within week.|
1655441|NCT01620255|3046812|Superiority or Other||Risk Difference (RD)|0.112||||0.1231|2-Sided|90.0|-0.038|0.261||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo|
1655442|NCT01620255|3046812|Superiority or Other||Risk Difference (RD)|0.096||||0.1473|2-Sided|90.0|-0.045|0.237||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo|
1655443|NCT01620255|3046812|Superiority or Other||Risk Difference (RD)|0.183||||0.0217|2-Sided|90.0|0.039|0.328||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo|
1655444|NCT01620255|3046812|Superiority or Other||Risk Difference (RD)|-0.002||||0.5201|2-Sided|90.0|-0.145|0.142||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo|
1655445|NCT01620255|3046813|Superiority or Other||LSM Difference|2.95||||0.006|2-Sided|90.0|1.19|4.715|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, social fx change from BL at W12|
1655446|NCT01620255|3046813|Superiority or Other||LSM Difference|1.86||||0.0729|2-Sided|90.0|0.154|3.557|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, social fx change from BL at W12|
1655447|NCT01620255|3046813|Superiority or Other||LSM Difference|2.17||||0.0384|2-Sided|90.0|0.447|3.891|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, social fx change from BL at W12|
1655448|NCT01620255|3046813|Superiority or Other||LSM Difference|-0.33||||0.7561|2-Sided|90.0|-2.094|1.429|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, social fx change from BL at W12|
1655449|NCT01620255|3046813|Superiority or Other||LSM Difference|1.66||||0.0686|2-Sided|90.0|0.161|3.153|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, systemic symptoms change from BL at W12|
1655450|NCT01620255|3046813|Superiority or Other||LSM Difference|1.68||||0.0558|2-Sided|90.0|0.235|3.12|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, systemic symptoms change from BL at W12|
1655451|NCT01620255|3046813|Superiority or Other||LSM Difference|1.69||||0.0582|2-Sided|90.0|0.223|3.147|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, systemic symptoms change from BL at W12|
1655452|NCT01620255|3046813|Superiority or Other||LSM Difference|-0.26||||0.7711|2-Sided|90.0|-1.756|1.229|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, systemic symptoms change from BL at W12|
1655453|NCT01620255|3046813|Superiority or Other||LSM Difference|5.9||||0.002|2-Sided|90.0|2.778|9.026|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, emotional fx change from BL at W12|
1655454|NCT01620255|3046813|Superiority or Other||LSM Difference|4.06||||0.0271|2-Sided|90.0|1.042|7.071|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, emotional fx change from BL at W12|
1655455|NCT01620255|3046813|Superiority or Other||LSM Difference|4.47||||0.0161|2-Sided|90.0|1.42|7.522|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, emotional fx change from BL at W12|
1655456|NCT01620255|3046813|Superiority or Other||LSM Difference|0.22||||0.9072|2-Sided|90.0|-2.897|3.339|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, emotional fx change from BL at W12|
1655457|NCT01620255|3046813|Superiority or Other||LSM Difference|5.2||||0.0041|2-Sided|90.0|2.232|8.172|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, bowel fx change from BL at W12|
1655458|NCT01620255|3046813|Superiority or Other||LSM Difference|4.16||||0.0171|2-Sided|90.0|1.293|7.023|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, bowel fx change from BL at W12|
1655459|NCT01620255|3046813|Superiority or Other||LSM Difference|4.37||||0.0135|2-Sided|90.0|1.467|7.28|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, bowel fx change from BL at W12|
1655460|NCT01620255|3046813|Superiority or Other||LSM Difference|-0.73||||0.6862|2-Sided|90.0|-3.689|2.235|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, bowel fx change from BL at W12|
1655461|NCT01620255|3046814|Superiority or Other||LSM Difference|15.48||||0.0026|2-Sided|90.0|7.056|23.907|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, change from BL at W12|
1655462|NCT01620255|3046814|Superiority or Other||LSM Difference|11.7||||0.0182|2-Sided|90.0|3.564|19.84|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, change from BL at W12|
1655463|NCT01620255|3046814|Superiority or Other||LSM Difference|12.33||||0.0141|2-Sided|90.0|4.084|20.567|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, change from BL at W12|
1655464|NCT01620255|3046814|Superiority or Other||LSM Difference|-1.1||||0.8302|2-Sided|90.0|-9.507|7.317|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, change from BL at W12|
1655465|NCT01620255|3046815|Superiority or Other||LSM Difference|-123.5||||0.1053|2-Sided|90.0|-249.0|1.93|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 12|
1655466|NCT01620255|3046815|Superiority or Other||LSM Difference|-163.6||||0.0279|2-Sided|90.0|-285.84|-41.29|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo,Week 12|
1655467|NCT01620255|3046815|Superiority or Other||LSM Difference|-41.7||||0.5784|2-Sided|90.0|-165.34|81.87|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 12|
1655468|NCT01620255|3046815|Superiority or Other||LSM Difference|-119.7||||0.1182|2-Sided|90.0|-245.66|6.32|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 12|
1655469|NCT01620255|3046815|Superiority or Other||LSM Difference|-96.4||||0.1931|2-Sided|90.0|-218.17|25.46|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 8|
1655470|NCT01620255|3046815|Superiority or Other||LSM Difference|-115.8||||0.1139|2-Sided|90.0|-236.29|4.69|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 8|
1655471|NCT01620255|3046815|Superiority or Other||LSM Difference|-115.2||||0.1183|2-Sided|90.0|-236.63|6.13|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 8|
1655472|NCT01620255|3046815|Superiority or Other||LSM Difference|-52.7||||0.4831|2-Sided|90.0|-176.48|71.02|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 8|
1655473|NCT01620255|3046815|Superiority or Other||LSM Difference|-17.0||||0.8224|2-Sided|90.0|-142.02|107.94|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 4|
1655574|NCT01619059|3046872|Superiority or Other||Risk Difference (RD)|12.2|Standard Error of the Mean|4.504|||2-Sided|95.0|3.4|21.0|||||||
1655474|NCT01620255|3046815|Superiority or Other||LSM Difference|11.5||||0.8775|2-Sided|90.0|-110.83|133.74|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 4|
1655475|NCT01620255|3046815|Superiority or Other||LSM Difference|-9.8||||0.8962|2-Sided|90.0|-132.91|113.39|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 4|
1655476|NCT01620255|3046815|Superiority or Other||LSM Difference|6.4||||0.9328|2-Sided|90.0|-118.6|131.41|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 4|
1655477|NCT01620255|3046816|Superiority or Other||LSM Difference|-3.0||||0.9615|2-Sided|90.0|-104.88|98.91|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 12|
1655478|NCT01620255|3046816|Superiority or Other||LSM Difference|78.5||||0.1918|2-Sided|90.0|-20.48|177.56|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo,Week 12|
1655479|NCT01620255|3046816|Superiority or Other||LSM Difference|36.0||||0.5474|2-Sided|90.0|-62.44|134.38|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 12|
1655480|NCT01620255|3046816|Superiority or Other||LSM Difference|-30.0||||0.6234|2-Sided|90.0|-130.56|70.57|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 12|
1655481|NCT01620255|3046816|Superiority or Other||LSM Difference|33.8||||0.57|2-Sided|90.0|-64.2|131.86|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 8|
1655482|NCT01620255|3046816|Superiority or Other||LSM Difference|-34.3||||0.5684|2-Sided|90.0|-133.49|64.79|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 8|
1655483|NCT01620255|3046816|Superiority or Other||LSM Difference|10.2||||0.8616|2-Sided|90.0|-86.14|106.54|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 8|
1655484|NCT01620255|3046816|Superiority or Other||LSM Difference|-8.2||||0.8902|2-Sided|90.0|-106.24|89.81|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 8|
1655485|NCT01620255|3046816|Superiority or Other||LSM Difference|37.6||||0.5388|2-Sided|90.0|-63.12|138.34|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Week 4|
1655486|NCT01620255|3046816|Superiority or Other||LSM Difference|32.9||||0.5808|2-Sided|90.0|-65.09|130.79|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Week 4|
1655487|NCT01620255|3046816|Superiority or Other||LSM Difference|74.9||||0.2023|2-Sided|90.0|-21.77|171.66|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Week 4|
1655488|NCT01620255|3046816|Superiority or Other||LSM Difference|-1.9||||0.9744|2-Sided|90.0|-101.0|97.14|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Week 4|
1655489|NCT01620255|3046817|Superiority or Other||LSM Difference|-0.23||||0.0748|2-Sided|90.0|-0.436|-0.018|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 225 mg vs placebo|
1655490|NCT01620255|3046817|Superiority or Other||LSM Difference|-0.34||||0.0063|2-Sided|90.0|-0.549|-0.137|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 75 mg vs placebo|
1655491|NCT01620255|3046817|Superiority or Other||LSM Difference|-0.42||||0.0007|2-Sided|90.0|-0.628|-0.221|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo|
1655492|NCT01620255|3046817|Superiority or Other||LSM Difference|-0.08||||0.5406|2-Sided|90.0|-0.286|0.131|||ANCOVA|ANCOVA with model terms: treatment group, baseline, status of anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo|
1655493|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.25||||0.0717|2-Sided|90.0|-0.485|-0.022|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W12|
1655494|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.25||||0.0788|2-Sided|90.0|-0.475|-0.016|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W12|
1655495|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.43||||0.0022|2-Sided|90.0|-0.653|-0.198|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W12|
1655496|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.23||||0.1133|2-Sided|90.0|-0.459|0.009|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W12|
1655497|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.18||||0.187|2-Sided|90.0|-0.41|0.045|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W8|
1655498|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.21||||0.1212|2-Sided|90.0|-0.441|0.013|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W8|
1655575|NCT01619059|3046873|Superiority or Other||Mean Difference (Final Values)|-3.7|Standard Error of the Mean|3.713|||2-Sided|95.0|-11.0|3.6|||||||
1655499|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.29||||0.0371|2-Sided|90.0|-0.512|-0.06|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W8|
1655500|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.1||||0.4962|2-Sided|90.0|-0.328|0.136|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W8|
1655501|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.14||||0.3161|2-Sided|90.0|-0.372|0.09|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, PGA, W4|
1655502|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.22||||0.1085|2-Sided|90.0|-0.453|0.006|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, PGA, W4|
1655503|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.23||||0.0998|2-Sided|90.0|-0.455|0.0|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, PGA, W4|
1655504|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.19||||0.1862|2-Sided|90.0|-0.421|0.046|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, PGA, W4|
1655505|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.4||||0.0008|2-Sided|90.0|-0.602|-0.206|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W12|
1655506|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.24||||0.0413|2-Sided|90.0|-0.439|-0.047|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W12|
1655507|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.32||||0.0073|2-Sided|90.0|-0.511|-0.123|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W12|
1655508|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.25||||0.0395|2-Sided|90.0|-0.449|-0.05|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W12|
1655509|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.47|||<|0.0001|2-Sided|90.0|-0.664|-0.275|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W8|
1655510|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.32|||<|0.0071|2-Sided|90.0|-0.511|-0.124|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W8|
1655511|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.24|||<|0.0402|2-Sided|90.0|-0.432|-0.048|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W8|
1655512|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.28|||<|0.0207|2-Sided|90.0|-0.475|-0.081|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W8|
1655513|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.39|||<|0.0012|2-Sided|90.0|-0.587|-0.192|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Rectal Bleeding, W4|
1655514|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.49|||<|0.0001|2-Sided|90.0|-0.686|-0.295|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Rectal Bleeding, W4|
1655515|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.52|||<|0.0001|2-Sided|90.0|-0.71|-0.322|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Rectal Bleeding, W4|
1655516|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.46|||<|0.0002|2-Sided|90.0|-0.658|-0.26|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Rectal Bleeding, W4|
1655517|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.35|||<|0.0231|2-Sided|90.0|-0.607|-0.097|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W12|
1655518|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.21|||<|0.1647|2-Sided|90.0|-0.465|0.039|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W12|
1655519|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.36|||<|0.0186|2-Sided|90.0|-0.608|-0.108|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W12|
1655520|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.22|||<|0.1611|2-Sided|90.0|-0.475|0.038|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W12|
1655521|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.5|||<|0.001|2-Sided|90.0|-0.755|-0.254|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W8|
1655522|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.39|||<|0.011|2-Sided|90.0|-0.637|-0.137|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W8|
1657006|NCT01597245|3049339|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1655523|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.31|||<|0.0422|2-Sided|90.0|-0.554|-0.058|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W8|
1655524|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.3|||<|0.0526|2-Sided|90.0|-0.555|-0.046|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W8|
1655525|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.38|||<|0.0132|2-Sided|90.0|-0.637|-0.129|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 225 mg vs placebo, Stool Frequency, W4|
1655526|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.22|||<|0.15|2-Sided|90.0|-0.472|0.031|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 75 mg vs placebo, Stool Frequency, W4|
1655527|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.28|||<|0.0654|2-Sided|90.0|-0.529|-0.03|||Mixed Models Analysis|LMM with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 22.5 mg vs placebo, Stool Frequency, W4|
1655528|NCT01620255|3046818|Superiority or Other||LSM Difference|-0.25|||<|0.1016|2-Sided|90.0|-0.511|0.001|||Mixed Models Analysis|Linear Mixed Model (LMM) with model terms: treatment group, time, baseline, time by treatment, status of previous anti-TNF therapy experience.||PF-00547659 7.5 mg vs placebo, Stool Frequency, W4|
1655529|NCT01620255|3046819|Superiority or Other||LSM Difference|-1.29||||0.0079|2-Sided|90.0|-2.082|-0.493|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 225 mg vs placebo, locally read change|
1655530|NCT01620255|3046819|Superiority or Other||LSM Difference|-1.07||||0.0255|2-Sided|90.0|-1.858|-0.284|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 75 mg vs placebo, locally read change|
1655531|NCT01620255|3046819|Superiority or Other||LSM Difference|-1.6||||0.0008|2-Sided|90.0|-2.372|-0.819|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 22.5 mg vs placebo, locally read change|
1655532|NCT01620255|3046819|Superiority or Other||LSM Difference|-0.94||||0.0543|2-Sided|90.0|-1.737|-0.137|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 7.5 mg vs placebo, locally read change|
1655533|NCT01620255|3046819|Superiority or Other||LSM Difference|-1.27||||0.0049|2-Sided|90.0|-2.016|-0.533|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 225 mg vs placebo, centrally read change|
1655534|NCT01620255|3046819|Superiority or Other||LSM Difference|-1.12||||0.0117|2-Sided|90.0|-1.845|-0.39|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 75 mg vs placebo, centrally read change|
1655535|NCT01620255|3046819|Superiority or Other||LSM Difference|-1.53||||0.0005|2-Sided|90.0|-2.254|-0.809|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 22.5 mg vs placebo, centrally read change|
1655536|NCT01620255|3046819|Superiority or Other||Least Squares Mean (LSM) Difference|-0.88||||0.0494|2-Sided|90.0|-1.623|-0.145|||ANCOVA|Analysis of covariance (ANCOVA) with model terms: treatment group, baseline, status of anti-tumor necrosis factor (TNF) therapy experience.||PF-00547659 7.5 mg vs placebo, centrally read change|
1655537|NCT01620255|3046821|Superiority or Other||Risk Difference (RD)|0.066||||0.2|2-Sided|90.0|-0.053|0.186||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read|
1655538|NCT01620255|3046821|Superiority or Other||Risk Difference (RD)|0.13||||0.0464|2-Sided|90.0|0.008|0.253||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read|
1655539|NCT01620255|3046821|Superiority or Other||Risk Difference (RD)|0.154||||0.0246|2-Sided|90.0|0.03|0.278||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read|
1655540|NCT01620255|3046821|Superiority or Other||Risk Difference (RD)|0.001||||0.5225|2-Sided|90.0|-0.111|0.114||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read|
1655541|NCT01620255|3046821|Superiority or Other||Risk Difference (RD)|0.069||||0.0999|2-Sided|90.0|-0.013|0.151||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read|
1655542|NCT01620255|3046821|Superiority or Other||Risk Difference (RD)|0.159||||0.0027|2-Sided|90.0|0.068|0.25||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read|
1655543|NCT01620255|3046821|Superiority or Other||Risk Difference (RD)|0.187||||0.0009|2-Sided|90.0|0.091|0.284||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read|
1655544|NCT01620255|3046821|Superiority or Other||Risk Difference (RD)|0.081||||0.0618|2-Sided|90.0|0.0|0.162||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, centrally read|
1655545|NCT01620255|3046822|Superiority or Other||Risk Difference (RD)|0.185||||0.0145|2-Sided|90.0|0.05|0.32||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read|
1655546|NCT01620255|3046822|Superiority or Other||Risk Difference (RD)|0.156||||0.0326|2-Sided|90.0|0.022|0.29||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read|
1655547|NCT01620255|3046822|Superiority or Other||Risk Difference (RD)|0.212||||0.0058|2-Sided|90.0|0.077|0.347||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read|
1655548|NCT01620255|3046822|Superiority or Other||Risk Difference (RD)|0.056||||0.2617|2-Sided|90.0|-0.075|0.186||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read|
1655549|NCT01620255|3046822|Superiority or Other||Risk Difference (RD)|0.213||||0.0052|2-Sided|90.0|0.08|0.347||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read|
1655550|NCT01620255|3046822|Superiority or Other||Risk Difference (RD)|0.163||||0.0239|2-Sided|90.0|0.032|0.293||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read|
1655551|NCT01620255|3046822|Superiority or Other||Risk Difference (RD)|0.254||||0.0011|2-Sided|90.0|0.121|0.388||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read|
1655552|NCT01620255|3046822|Superiority or Other||Risk Difference (RD)|0.089||||0.1379|2-Sided|90.0|-0.037|0.214||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, centrally read|
1655553|NCT01620255|3046823|Superiority or Other||Risk Difference (RD)|0.066||||0.0927|2-Sided|90.0|-0.009|0.142||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, locally read|
1655554|NCT01620255|3046823|Superiority or Other||Risk Difference (RD)|0.122||||0.0125|2-Sided|90.0|0.036|0.208||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, locally read|
1655555|NCT01620255|3046823|Superiority or Other||Risk Difference (RD)|0.178||||0.0014|2-Sided|90.0|0.083|0.272||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, locally read|
1655556|NCT01620255|3046823|Superiority or Other||Risk Difference (RD)|0.08||||0.0582|2-Sided|90.0|0.002|0.159||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg vs placebo, locally read|
1655557|NCT01620255|3046823|Superiority or Other||Risk Difference (RD)|0.026||||0.1803|2-Sided|90.0|-0.012|0.064||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 225 mg vs placebo, centrally read|
1655558|NCT01620255|3046823|Superiority or Other||Risk Difference (RD)|0.118||||0.004|2-Sided|90.0|0.048|0.188||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 75 mg vs placebo, centrally read|
1655559|NCT01620255|3046823|Superiority or Other||Risk Difference (RD)|0.128||||0.0025|2-Sided|90.0|0.056|0.199||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 22.5 mg vs placebo, centrally read|
1655560|NCT01620255|3046823|Superiority or Other||Risk Difference (RD)|0.08||||0.0213|2-Sided|90.0|0.019|0.14||1-sided p-value|Cochran-Mantel-Haenszel|Statistics of risk difference are calculated using the Minimum Risk Weights test.|Statistics of risk difference are calculated using the Minimum Risk Weights test.|PF-00547659 7.5 mg versus (vs) placebo, centrally read|
1655561|NCT01620138|3046827|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1655562|NCT01619852|3046852|Superiority or Other (legacy)|||||||0.29|||||||Wilcoxon (Mann-Whitney)||||
1655563|NCT01619852|3046853|Superiority or Other (legacy)|||||||0.19|||||||Wilcoxon (Mann-Whitney)||||
1655564|NCT01619852|3046854|Superiority or Other (legacy)|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||Brief Pain Inventory|
1655565|NCT01619852|3046854|Superiority or Other (legacy)|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||McGill Questionnaire-affective dimension|
1655566|NCT01619852|3046854|Superiority or Other (legacy)|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||McGill Questionnaire-Sensory-discriminative dimension|
1655567|NCT01619852|3046854|Superiority or Other (legacy)|||||||0.68|||||||Wilcoxon (Mann-Whitney)||||
1655568|NCT01619852|3046855|Superiority or Other (legacy)|||||||0.64|||||||Wilcoxon (Mann-Whitney)||||
1655569|NCT01619852|3046856|Superiority or Other (legacy)|||||||0.19|||||||Wilcoxon (Mann-Whitney)||||
1655570|NCT01619423|3046866|Superiority||Odds Ratio (OR)|0.62||||0.16|1-Sided|10.0||1.14|||Cochran-Mantel-Haenszel||||
1655571|NCT01619423|3046866|Superiority||Odds Ratio (OR)|0.55||||0.15|1-Sided|10.0||1.16|||Cochran-Mantel-Haenszel||||
1655572|NCT01619423|3046866|Superiority||Odds Ratio (OR)|0.78||||0.31|1-Sided|10.0||1.5|||Cochran-Mantel-Haenszel||||
1655576|NCT01619059|3046874|Superiority or Other||Mean Difference (Final Values)|-5.9|Standard Error of the Mean|4.576||0.2014|2-Sided|95.0|-14.9|3.1||Secondary endpoints were tested at alpha=0.05, applying the hierarchical order for the sequential testing procedure|Mixed Models Analysis||||
1655577|NCT01619059|3046875|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.087|<|0.0001|2-Sided|95.0|-0.52|-0.18||Tested at alpha=0.05|Mixed Models Analysis||||
1655578|NCT01618968|3046876|Non-Inferiority or Equivalence|Test of bioequivalence was performed at each dose level.|Test / Reference Ratio|115.63|||||2-Sided|90.0|108.83|122.86||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)|
1655579|NCT01618968|3046876|Non-Inferiority or Equivalence|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|82.12|||||2-Sided|90.0|76.16|88.55||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)|
1655580|NCT01618968|3046876|Non-Inferiority or Equivalence|Bioavailability comparisons were performed at each dose level.|Test / Reference ratio|94.83|||||2-Sided|90.0|86.42|104.06||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the maximum observed concentration (Cmax)|
1655581|NCT01618968|3046877|Non-Inferiority or Equivalence|Test of bioequivalence was performed at each dose level.|Test / Reference Ratio|101.82|||||2-Sided|90.0|99.39|104.31||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)|
1655582|NCT01618968|3046877|Non-Inferiority or Equivalence|Bioavailability comparisons were performed at each dose level.|Test / Reference ratio|125.2|||||2-Sided|90.0|119.16|131.55||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the thigh using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)|
1655583|NCT01618968|3046877|Non-Inferiority or Equivalence|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|127.65|||||2-Sided|90.0|121.28|134.36||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the 24 hour concentration AUC(0-24)|
1655584|NCT01618968|3046878|Non-Inferiority or Equivalence|Test of bioequivalence was performed at each dose level.|Test / Reference ratio|101.85|||||2-Sided|90.0|99.41|104.36||||||To compare the relative bioavailability of MTX following SC injection into the abdomen to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-inf)|
1655585|NCT01618968|3046878|Non-Inferiority or Equivalence|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|125.48|||||2-Sided|90.0|119.43|131.84||||||To compare the relative bioavailability of MTX following oral administration to that obtained after SC injection into the thigh using the VIBEX MTX device by measuring the AUC(0-Inf).|
1655586|NCT01618968|3046878|Non-Inferiority or Equivalence|Bioavailability comparisons were performed at each dose level.|Test / Reference Ratio|127.99|||||2-Sided|90.0|121.61|134.7||||||To compare the relative bioavailability of methotrexate (MTX) following oral administration to that obtained after subcutaneous (SC) injection into the abdomen using the VIBEX MTX device by measuring the area under the curve from time zero to the last measurable concentration AUC(0-inf).|
1655587|NCT01618916|3046891|Superiority or Other||Mean Difference (Net)|-17.93||||0.042||90.0|-32.42|-3.44|||Mixed Effect Model Analysis|P-value is for Day 127.|||
1655588|NCT01618916|3046891|Superiority or Other||Mean Difference (Net)|-22.41||||0.013||90.0|-37.13|-7.69|||Mixed Effect Model Analysis|P-value is for Day 127.|||
1655589|NCT01618916|3046891|Superiority or Other||Mean Difference (Net)|-14.1||||0.108||90.0|-28.53|0.33|||Mixed Effect Model Analysis|P-value is for Day 127.|||
1655590|NCT01618916|3046891|Superiority or Other||Mean Difference (Net)|-6.53||||0.44||90.0|-20.51|7.44|||Mixed Effect Model Analysis|P-value is for Day 127|||
1655591|NCT01618916|3046891|Superiority or Other||Mean Difference (Net)|-44.64|||<|0.001||90.0|-58.95|-30.32|||Mixed Effects Model Analysis|P-value is for Day 57.|||
1655592|NCT01618916|3046891|Superiority or Other||Mean Difference (Net)|-46.8|||<|0.001||90.0|-61.12|-32.49|||Mixed Effects Model Analysis|P-value is for Day 43.|||
1655593|NCT01618916|3046891|Superiority or Other||Mean Difference (Net)|-32.04|||<|0.001||90.0|-46.76|-17.32|||Mixed Effects Model Analysis|P-value is for Day 57.|||
1655594|NCT01618916|3046891|Superiority or Other||Mean Difference (Net)|-45.36|||<|0.001||90.0|-60.07|-30.64|||Mixed Effects Model Analysis|P-value is for Day 43.|||
1655595|NCT01618916|3046891|Superiority or Other||Mean Difference (Net)|-32.26|||<|0.001||90.0|-46.69|-17.82|||Mixed Effects Model Analysis|P-value is for Day 57.|||
1655596|NCT01618916|3046891|Superiority or Other||Mean Difference (Net)|-47.72|||<|0.001||90.0|-62.1|-33.34|||Mixed Effects Model Analysis|P-value is for Day 43.|||
1655597|NCT01618916|3046891|Superiority or Other||Mean Difference (Net)|-34.85|||<|0.001||90.0|-48.78|-20.93|||Mixed Effects Model Analysis|P-value is for Day 57.|||
1655598|NCT01618916|3046891|Superiority or Other||Mean Difference (Net)|-49.92|||<|0.001||90.0|-63.84|-35.99|||Mixed Effects Model Analysis|P-value is for Day 43.|||
1655599|NCT01618708|3046905|Superiority or Other||Least Squares (LS) Mean difference|0.07|||=|0|2-Sided|95.0|-0.38|0.52||Threshold for significance at 0.05 level|Mixed Models Analysis||Placebo vs Synvisc-One|Synvisc-One group was compared to placebo group using mixed model for repeated measures (MMRM) approach assuming missing data at random (MAR).|
1655600|NCT01618669|3046913|Superiority or Other||Difference|0.02|Standard Error of the Mean|0.022|||2-Sided|95.0|-0.03|0.06|||||||
1655601|NCT01618669|3046914|Non-Inferiority or Equivalence|The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.133 in order to demonstrate non-inferiority. Non-inferiority could not be assessed because of insufficient data in the Regadenoson Alone group.|Difference|-0.02|Standard Error of the Mean|0.027|||2-Sided|95.0|-0.07|0.04|||||||
1655602|NCT01618669|3046915|Non-Inferiority or Equivalence|The lower confidence bound of the 1-sided alpha level of 0.025 of the difference in agreement rates must exceed -0.10 in order to demonstrate non-inferiority.|Difference|-0.01|Standard Error of the Mean|0.063|||2-Sided|95.0|-0.14|0.11|||||Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone||
1655603|NCT01618669|3046917|Non-Inferiority or Equivalence|If the lower confidence bound of the 1-sided alpha level of 0.025 of the difference in the proportion of participants with majority reader self-agreement exceeded -0.075, non-inferiority would be demonstrated.|Difference|-0.03|Standard Error of the Mean|0.015|||2-Sided|95.0|-0.06|0.0|||||Difference equals Regadenoson After Peak Exercise minus Regadenoson Alone||
1655604|NCT01618305|3046922|Superiority|||||||0.064|||||||Fisher Exact|||The proportion of HIV-infected infants among those who had a determinable HIV-infection status was compared between arms.|
1655605|NCT01618305|3046923|Superiority||||||>|0.99|||||||Fisher Exact||||
1655606|NCT01618305|3046924|Superiority||||||>|0.99|||||||Fisher Exact||||
1655607|NCT01618305|3046925|Superiority|||||||0.54|||||||Fisher Exact||||
1655608|NCT01618305|3046926|Superiority|||||||0.63|||||||Fisher Exact||||
1655609|NCT01618305|3046927|Superiority|||||||0.623|||||||Fisher Exact||||
1655610|NCT01618305|3046932|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-<28 weeks; 28-<31 weeks; 31-<34 weeks; 34-<37 weeks).|||
1655611|NCT01618305|3046933|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-<28 weeks; 28-<31 weeks; 31-<34 weeks; 34-<37 weeks).|||
1655612|NCT01618305|3046934|Superiority|||||||0.938|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by maternal gestational age at entry (20-<28 weeks; 28-<31 weeks; 31-<34 weeks; 34-<37 weeks).|||
1655613|NCT01618305|3046935|Superiority|||||||0.909|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-<28 weeks; 28-<31 weeks; 31-<34 weeks; 34-<37 weeks).|||
1655614|NCT01618305|3046936|Superiority|||||||0.557|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by gestational age at entry (20-<28 weeks; 28-<31 weeks; 31-<34 weeks; 34-<37 weeks)|||
1655615|NCT01618305|3046937|Superiority|P-value was calculated using a Cochran-Mantel-Haenszel test, stratified by gestational age at entry (20-<28 weeks; 28-<31 weeks; 31-<34 weeks; 34-<37 weeks)||||||0.001|||||||Cochran-Mantel-Haenszel||||
1655616|NCT01618214|3046960|Non-Inferiority or Equivalence|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.4%.|Mean Difference (Final Values)|-0.02|Standard Deviation|0.08||||95.0|-0.19|0.14||||||FAS|
1655617|NCT01618162|3046967|Superiority or Other||Estimated treatment difference|-1.02|||<|0.001|2-Sided|95.0|-1.18|-0.87|||ANCOVA|||Superiority of IDegLira versus placebo therapy would be concluded if the 95% CI for the treatment differences for change in HbA1c lied entirely below 0%; implying that the two-sided p-value calculated by the ANCOVA model for testing the hypothesis of no difference between treatments was less than 5%.|
1655618|NCT01617681|3046984|Other||Odds Ratio (OR)|0.517||||0.2624|2-Sided|95.0|0.16|1.64|||ANCOVA||||
1655619|NCT01617681|3046985|Other||Odds Ratio (OR)|1.45||||0.5443|2-Sided|95.0|0.44|4.79|||ANCOVA||||
1655620|NCT01617681|3046985|Other||Odds Ratio (OR)|1.68||||0.411|2-Sided|95.0|0.49|5.8|||ANCOVA||||
1655621|NCT01617681|3046986|Other||Mean Difference (Net)|-5.4|Standard Error of the Mean|1.8||0.0042|2-Sided|95.0|-8.98|-1.77|||ANCOVA||||
1655622|NCT01617681|3046986|Other||Mean Difference (Net)|-7.9|Standard Error of the Mean|2.54||0.003|2-Sided|95.0|-12.94|-2.78|||ANCOVA||||
1655623|NCT01617681|3046987|Other||Mean Difference (Net)|-0.9|Standard Error of the Mean|2.07||0.6531|2-Sided|95.0|-5.07|3.2|||ANCOVA||||
1655624|NCT01617681|3046987|Other||Mean Difference (Net)|-7.9|Standard Error of the Mean|2.96||0.0096|2-Sided|95.0|-13.86|-2.01|||ANCOVA||||
1655625|NCT01617655|3047012|Superiority or Other||LS mean difference|3.7||||0.2745|2-Sided|95.0|-2.9|10.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655626|NCT01617655|3047013|Superiority or Other||Adjusted Mean Difference|-14.8||||0.0164|2-Sided|95.0|-26.9|-2.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by robust regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655627|NCT01617655|3047014|Superiority or Other||Odds Ratio (OR)|11.9||||0.0014|2-Sided|95.0|2.6|54.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655628|NCT01617655|3047015|Superiority or Other||Odds Ratio (OR)|11.7||||0.0016|2-Sided|95.0|2.5|53.5||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655629|NCT01617655|3047016|Superiority or Other||LS mean difference|-39.1|||<|0.0001|2-Sided|95.0|-53.6|-24.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655630|NCT01617655|3047017|Superiority or Other||LS mean difference|-27.8|||<|0.0001|2-Sided|95.0|-36.2|-19.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655631|NCT01617655|3047018|Superiority or Other||LS mean difference|-34.5|||<|0.0001|2-Sided|95.0|-44.8|-24.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655655|NCT01617187|3047053|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.53||0.9399|2-Sided|95.0|-1.1|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35|
1655632|NCT01617655|3047019|Superiority or Other||LS mean difference|-30.2|||<|0.0001|2-Sided|95.0|-39.2|-21.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655633|NCT01617655|3047020|Superiority or Other||LS mean difference|-28.4|||<|0.0001|2-Sided|95.0|-37.3|-19.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655634|NCT01617655|3047021|Superiority or Other||LS mean difference|-35.5|||<|0.0001|2-Sided|95.0|-46.2|-24.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655635|NCT01617655|3047022|Superiority or Other||LS mean difference|-35.8|||<|0.0001|2-Sided|95.0|-46.3|-25.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655636|NCT01617655|3047023|Superiority or Other||LS mean difference|-30.2|||<|0.0001|2-Sided|95.0|-39.7|-20.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655637|NCT01617655|3047024|Superiority or Other||LS mean difference|-30.3|||<|0.0001|2-Sided|95.0|-39.7|-20.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655638|NCT01617655|3047025|Superiority or Other||LS mean difference|-40.3|||<|0.0001|2-Sided|95.0|-51.4|-29.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655639|NCT01617655|3047026|Superiority or Other||LS mean difference|-40.3|||<|0.0001|2-Sided|95.0|-51.4|-29.3||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1655640|NCT01617655|3047027|Superiority or Other||LS mean difference|-38.9|||<|0.0001|2-Sided|95.0|-51.0|-26.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|
1655641|NCT01617655|3047028|Superiority or Other||LS mean difference|-39.1|||<|0.0001|2-Sided|95.0|-51.1|-27.1||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.|
1655642|NCT01617577|3047035|Superiority or Other|||||||0.034|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||PALtot trials adj at baseline vs 14wk (final visit)|
1655643|NCT01617577|3047035|Superiority or Other|||||||0.058|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||PAL(mem) at baseline and 14 wk (final visit): null hypothesis is thereis no difference in score|
1655644|NCT01617577|3047035|Superiority or Other|||||||0.36|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test||ADAScog scores at baseline vs final visit (wk 14); null hypothesis is there is no difference between scores|
1655645|NCT01617434|3047042|Superiority or Other||Odds Ratio (OR)|20.12|||<|0.0001||95.0|9.92|40.84|||Regression, Logistic|||This endpoint was analysed using a logistic regression model with treatment and stratification factors as fixed factors and the HbA1c value at baseline as a covariate. Subjects previously treated with insulin detemir without the use of metformin were not included in the analysis due to the small size of the stratum.|
1655646|NCT01617434|3047043|Superiority or Other||Odds Ratio (OR)|8.91|||<|0.0001||95.0|5.45|14.59|||Regression, Logistic|||This endpoint was analysed using a logistic regression model with treatment and stratification factors as fixed factors and the HbA1c value at baseline as a covariate. Subjects previously treated with insulin detemir without the use of metformin were not included in the analysis due to the small size of the stratum.|
1655647|NCT01617434|3047044|Superiority or Other||Mean Difference (Final Values)|-3.11|||<|0.0001||95.0|-3.85|-2.37|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.|
1655648|NCT01617434|3047045|Superiority or Other||Mean Difference (Final Values)|-1.59|||<|0.0001||95.0|-2.01|-1.18|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.|
1655649|NCT01617434|3047046|Superiority or Other||Mean Difference (Final Values)|-1.28|||<|0.0001||95.0|-1.7|-0.86|||Mixed Models Analysis|||The response was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline as a covariate, all nested within visit.|
1655650|NCT01617434|3047047|Superiority or Other||Mean Difference (Final Values)|-1.19|||<|0.0001||95.0|-1.39|-0.99|||Mixed Models Analysis|||The null hypothesis of no difference between the two treatment arms with regard to changes from baseline in HbA1c (%) after 26 weeks of randomised treatment was analysed using a mixed model repeated measurements (MMRM) analysis with treatment, country, stratification groups as factors and baseline HbA1c as a covariate, all nested within visit.|
1655651|NCT01617369|3047052|Superiority||||||<|0.05|||||||t-test, 2 sided|||Paired t-test performed. Null hypothesis is that no difference in clearance 30 min and 4 hr after HS inhalation exists|
1655652|NCT01617187|3047053|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.62||0.8215|2-Sided|95.0|-1.4|1.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42|
1655653|NCT01617187|3047053|Superiority or Other||LS means difference|-0.5|Standard Error of the Mean|0.51||0.3681|2-Sided|95.0|-1.5|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42|
1655654|NCT01617187|3047053|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.54||0.8955|2-Sided|95.0|-1.0|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42|
1655656|NCT01617187|3047053|Superiority or Other||LS means difference|-0.5|Standard Error of the Mean|0.43||0.2889|2-Sided|95.0|-1.3|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35|
1655657|NCT01617187|3047053|Superiority or Other||LS means difference|0.2|Standard Error of the Mean|0.45||0.6556|2-Sided|95.0|-0.7|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35|
1655658|NCT01617187|3047053|Superiority or Other||LS means difference|0.6|Standard Error of the Mean|0.57||0.2981|2-Sided|95.0|-0.5|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28|
1655659|NCT01617187|3047053|Superiority or Other||LS means difference|0.2|Standard Error of the Mean|0.46||0.633|2-Sided|95.0|-0.7|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28|
1655660|NCT01617187|3047053|Superiority or Other||LS means difference|1.4|Standard Error of the Mean|0.49||0.004|2-Sided|95.0|0.5|2.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28|
1655661|NCT01617187|3047053|Superiority or Other||LS means difference|0.3|Standard Error of the Mean|0.52||0.5044|2-Sided|95.0|-0.7|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21|
1655662|NCT01617187|3047053|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.41||0.8667|2-Sided|95.0|-0.7|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1655663|NCT01617187|3047053|Superiority or Other||LS means difference|1.0|Standard Error of the Mean|0.44||0.0283|2-Sided|95.0|0.1|1.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21|
1655664|NCT01617187|3047053|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.51||0.8978|2-Sided|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14|
1655665|NCT01617187|3047053|Superiority or Other||LS means difference|-0.4|Standard Error of the Mean|0.4||0.286|2-Sided|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1655666|NCT01617187|3047053|Superiority or Other||LS means difference|0.6|Standard Error of the Mean|0.42||0.1499|2-Sided|95.0|-0.2|1.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14|
1655667|NCT01617187|3047053|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.52||0.8867|2-Sided|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7|
1655668|NCT01617187|3047053|Superiority or Other||LS means difference|-0.5|Standard Error of the Mean|0.4||0.2321|2-Sided|95.0|-1.3|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1655669|NCT01617187|3047053|Superiority or Other||LS means difference|0.2|Standard Error of the Mean|0.41||0.5635|2-Sided|95.0|-0.6|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7|
1655670|NCT01617187|3047053|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.46||0.8559|2-Sided|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4|
1655671|NCT01617187|3047053|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.36||0.4912|2-Sided|95.0|-0.9|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4|
1655672|NCT01617187|3047053|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.37||0.9851|2-Sided|95.0|-0.7|0.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4|
1655673|NCT01617187|3047054|Superiority or Other||LS means difference|-0.8|Standard Error of the Mean|0.64||0.1909|2-Sided|95.0|-2.1|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42|
1655674|NCT01617187|3047054|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.52||0.1722|2-Sided|95.0|-1.7|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42|
1655675|NCT01617187|3047054|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.56||0.9336|2-Sided|95.0|-1.0|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42|
1655676|NCT01617187|3047054|Superiority or Other||LS means difference|-0.6|Standard Error of the Mean|0.58||0.3288|2-Sided|95.0|-1.7|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35|
1655677|NCT01617187|3047054|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.47||0.8741|2-Sided|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35|
1655678|NCT01617187|3047054|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.5||0.9805|2-Sided|95.0|-1.0|1.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35|
1655679|NCT01617187|3047054|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.65||0.311|2-Sided|95.0|-1.9|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28|
1655680|NCT01617187|3047054|Superiority or Other||LS means difference|0.2|Standard Error of the Mean|0.52||0.7437|2-Sided|95.0|-0.9|1.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28|
1655681|NCT01617187|3047054|Superiority or Other||LS means difference|0.4|Standard Error of the Mean|0.55||0.4219|2-Sided|95.0|-0.6|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28|
1655682|NCT01617187|3047054|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.54||0.1715|2-Sided|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21|
1655683|NCT01617187|3047054|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.43||0.7307|2-Sided|95.0|-0.7|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1655684|NCT01617187|3047054|Superiority or Other||LS means difference|0.3|Standard Error of the Mean|0.45||0.5583|2-Sided|95.0|-0.6|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21|
1655685|NCT01617187|3047054|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.5||0.5694|2-Sided|95.0|-1.3|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14|
1655686|NCT01617187|3047054|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.39||0.7691|2-Sided|95.0|-0.7|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1655687|NCT01617187|3047054|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.41||0.9321|2-Sided|95.0|-0.8|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14|
1656013|NCT01614457|3047262|Superiority or Other||Hazard Ratio (HR)|0.928||||0.8556|2-Sided||||||Cox Proportional Hazard Regression||||
1655688|NCT01617187|3047054|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.48||0.486|2-Sided|95.0|-1.3|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7|
1655689|NCT01617187|3047054|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.37||0.7176|2-Sided|95.0|-0.6|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1655690|NCT01617187|3047054|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.38||0.7307|2-Sided|95.0|-0.6|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7|
1655691|NCT01617187|3047054|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.43||0.6413|2-Sided|95.0|-1.0|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4|
1655692|NCT01617187|3047054|Superiority or Other||LS means difference|0.2|Standard Error of the Mean|0.33||0.5859|2-Sided|95.0|-0.5|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4|
1655693|NCT01617187|3047054|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.34||0.7847|2-Sided|95.0|-0.6|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4|
1655694|NCT01617187|3047055|Superiority or Other||LS means difference|-2.0|Standard Error of the Mean|0.71||0.0056|2-Sided|95.0|-3.4|-0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42|
1655695|NCT01617187|3047055|Superiority or Other||LS means difference|-1.6|Standard Error of the Mean|0.58||0.0063|2-Sided|95.0|-2.7|-0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42|
1655696|NCT01617187|3047055|Superiority or Other||LS means difference|-1.1|Standard Error of the Mean|0.62||0.0691|2-Sided|95.0|-2.3|0.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42|
1655697|NCT01617187|3047055|Superiority or Other||LS means difference|-1.9|Standard Error of the Mean|0.69||0.0058|2-Sided|95.0|-3.3|-0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35|
1655698|NCT01617187|3047055|Superiority or Other||LS means difference|-1.1|Standard Error of the Mean|0.55||0.0415|2-Sided|95.0|-2.2|0.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35|
1655699|NCT01617187|3047055|Superiority or Other||LS means difference|-1.1|Standard Error of the Mean|0.58||0.055|2-Sided|95.0|-2.3|0.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35|
1655700|NCT01617187|3047055|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.67||0.303|2-Sided|95.0|-2.0|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28|
1655701|NCT01617187|3047055|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.53||0.189|2-Sided|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28|
1655702|NCT01617187|3047055|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.57||0.986|2-Sided|95.0|-1.1|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28|
1655703|NCT01617187|3047055|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.66||0.3241|2-Sided|95.0|-2.0|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21|
1655704|NCT01617187|3047055|Superiority or Other||LS means difference|-0.4|Standard Error of the Mean|0.53||0.4606|2-Sided|95.0|-1.4|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1655705|NCT01617187|3047055|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.56||0.7368|2-Sided|95.0|-1.3|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21|
1655706|NCT01617187|3047055|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.6||0.2321|2-Sided|95.0|-1.9|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14|
1655707|NCT01617187|3047055|Superiority or Other||LS means difference|-0.5|Standard Error of the Mean|0.47||0.2679|2-Sided|95.0|-1.4|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1655708|NCT01617187|3047055|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.49||0.783|2-Sided|95.0|-0.8|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14|
1655709|NCT01617187|3047055|Superiority or Other||LS means difference|-0.9|Standard Error of the Mean|0.54||0.1|2-Sided|95.0|-2.0|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7|
1655710|NCT01617187|3047055|Superiority or Other||LS means difference|-0.6|Standard Error of the Mean|0.42||0.1489|2-Sided|95.0|-1.4|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1655711|NCT01617187|3047055|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.44||0.5909|2-Sided|95.0|-1.1|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7|
1655712|NCT01617187|3047055|Superiority or Other||LS means difference|-0.4|Standard Error of the Mean|0.4||0.2959|2-Sided|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4|
1655713|NCT01617187|3047055|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.31||0.9039|2-Sided|95.0|-0.6|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4|
1655714|NCT01617187|3047055|Superiority or Other||LS means difference|0.4|Standard Error of the Mean|0.32||0.2116|2-Sided|95.0|-0.2|1.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4|
1655715|NCT01617187|3047056|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.83||0.7308|2-Sided|95.0|-1.9|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42|
1655716|NCT01617187|3047056|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.68||0.2873|2-Sided|95.0|-2.1|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42|
1655717|NCT01617187|3047056|Superiority or Other||LS means difference|0.6|Standard Error of the Mean|0.72||0.4246|2-Sided|95.0|-0.8|2.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42|
1655718|NCT01617187|3047056|Superiority or Other||LS means difference|-1.1|Standard Error of the Mean|0.83||0.1756|2-Sided|95.0|-2.8|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35|
1655719|NCT01617187|3047056|Superiority or Other||LS means difference|-0.8|Standard Error of the Mean|0.66||0.2128|2-Sided|95.0|-2.1|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35|
1655720|NCT01617187|3047056|Superiority or Other||LS means difference|-0.5|Standard Error of the Mean|0.7||0.483|2-Sided|95.0|-1.9|0.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35|
1655721|NCT01617187|3047056|Superiority or Other||LS means difference|0.2|Standard Error of the Mean|0.82||0.7673|2-Sided|95.0|-1.4|1.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28|
1655722|NCT01617187|3047056|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.65||0.681|2-Sided|95.0|-1.6|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28|
1655723|NCT01617187|3047056|Superiority or Other||LS means difference|0.6|Standard Error of the Mean|0.7||0.4267|2-Sided|95.0|-0.8|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28|
1655724|NCT01617187|3047056|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.73||0.9435|2-Sided|95.0|-1.5|1.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21|
1655725|NCT01617187|3047056|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.58||0.2388|2-Sided|95.0|-1.8|0.5||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1655726|NCT01617187|3047056|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.61||0.8363|2-Sided|95.0|-1.3|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21|
1655727|NCT01617187|3047056|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.68||0.7662|2-Sided|95.0|-1.5|1.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14|
1655728|NCT01617187|3047056|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.53||0.1624|2-Sided|95.0|-1.8|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1655729|NCT01617187|3047056|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.56||0.9956|2-Sided|95.0|-1.1|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14|
1655730|NCT01617187|3047056|Superiority or Other||LS means difference|-0.4|Standard Error of the Mean|0.63||0.506|2-Sided|95.0|-1.7|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7|
1655731|NCT01617187|3047056|Superiority or Other||LS means difference|-0.6|Standard Error of the Mean|0.49||0.2158|2-Sided|95.0|-1.6|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1655732|NCT01617187|3047056|Superiority or Other||LS means difference|-0.4|Standard Error of the Mean|0.51||0.4741|2-Sided|95.0|-1.4|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7|
1655733|NCT01617187|3047056|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.51||0.8439|2-Sided|95.0|-1.1|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4|
1655734|NCT01617187|3047056|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.39||0.85|2-Sided|95.0|-0.8|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4|
1655735|NCT01617187|3047056|Superiority or Other||LS means difference|-0.4|Standard Error of the Mean|0.4||0.2754|2-Sided|95.0|-1.2|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4|
1655736|NCT01617187|3047057|Superiority or Other||LS means difference|-1.6|Standard Error of the Mean|1.06||0.1411|2-Sided|95.0|-3.7|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42|
1655737|NCT01617187|3047057|Superiority or Other||LS means difference|-1.4|Standard Error of the Mean|0.86||0.1046|2-Sided|95.0|-3.1|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42|
1655738|NCT01617187|3047057|Superiority or Other||LS means difference|-0.6|Standard Error of the Mean|0.91||0.4762|2-Sided|95.0|-2.4|1.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42|
1655739|NCT01617187|3047057|Superiority or Other||LS means difference|-0.8|Standard Error of the Mean|1.03||0.4419|2-Sided|95.0|-2.8|1.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35|
1655740|NCT01617187|3047057|Superiority or Other||LS means difference|-0.6|Standard Error of the Mean|0.82||0.4758|2-Sided|95.0|-2.2|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35|
1655741|NCT01617187|3047057|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.87||0.972|2-Sided|95.0|-1.7|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35|
1655742|NCT01617187|3047057|Superiority or Other||LS means difference|-1.0|Standard Error of the Mean|0.96||0.3014|2-Sided|95.0|-2.9|0.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28|
1655743|NCT01617187|3047057|Superiority or Other||LS means difference|-0.6|Standard Error of the Mean|0.77||0.4253|2-Sided|95.0|-2.1|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28|
1655744|NCT01617187|3047057|Superiority or Other||LS means difference|0.9|Standard Error of the Mean|0.82||0.279|2-Sided|95.0|-0.7|2.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28|
1655745|NCT01617187|3047057|Superiority or Other||LS means difference|-0.5|Standard Error of the Mean|0.91||0.6099|2-Sided|95.0|-2.3|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21|
1655746|NCT01617187|3047057|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.72||0.6288|2-Sided|95.0|-1.8|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1655747|NCT01617187|3047057|Superiority or Other||LS means difference|0.6|Standard Error of the Mean|0.76||0.4601|2-Sided|95.0|-0.9|2.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21|
1655748|NCT01617187|3047057|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.81||0.7097|2-Sided|95.0|-1.9|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14|
1655749|NCT01617187|3047057|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.64||0.89|2-Sided|95.0|-1.2|1.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1655750|NCT01617187|3047057|Superiority or Other||LS means difference|0.2|Standard Error of the Mean|0.67||0.7647|2-Sided|95.0|-1.1|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14|
1655751|NCT01617187|3047057|Superiority or Other||LS means difference|-0.4|Standard Error of the Mean|0.7||0.5526|2-Sided|95.0|-1.8|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7|
1655752|NCT01617187|3047057|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.54||0.788|2-Sided|95.0|-1.2|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1656151|NCT01608100|3047894|Superiority or Other||Percent Specificity|84.05|||||2-Sided|95.0|81.31|86.54||||||Time point: 4-9 hours|
1655753|NCT01617187|3047057|Superiority or Other||LS means difference|0.3|Standard Error of the Mean|0.56||0.6161|2-Sided|95.0|-0.8|1.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7|
1655754|NCT01617187|3047057|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.49||0.9693|2-Sided|95.0|-0.9|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4|
1655755|NCT01617187|3047057|Superiority or Other||LS means difference|0.2|Standard Error of the Mean|0.38||0.5197|2-Sided|95.0|-0.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4|
1655756|NCT01617187|3047057|Superiority or Other||LS means difference|0.7|Standard Error of the Mean|0.39||0.0584|2-Sided|95.0|0.0|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4|
1655757|NCT01617187|3047058|Superiority or Other||LS means difference|-2.4|Standard Error of the Mean|1.52||0.1217|2-Sided|95.0|-5.4|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42|
1655758|NCT01617187|3047058|Superiority or Other||LS means difference|-2.2|Standard Error of the Mean|1.24||0.0842|2-Sided|95.0|-4.6|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42|
1655759|NCT01617187|3047058|Superiority or Other||LS means difference|-0.9|Standard Error of the Mean|1.32||0.5128|2-Sided|95.0|-3.5|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42|
1655760|NCT01617187|3047058|Superiority or Other||LS means difference|-2.6|Standard Error of the Mean|1.42||0.0663|2-Sided|95.0|-5.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35|
1655761|NCT01617187|3047058|Superiority or Other||LS means difference|-1.6|Standard Error of the Mean|1.13||0.1723|2-Sided|95.0|-3.8|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35|
1655762|NCT01617187|3047058|Superiority or Other||LS means difference|-1.2|Standard Error of the Mean|1.2||0.3133|2-Sided|95.0|-3.6|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35|
1655763|NCT01617187|3047058|Superiority or Other||LS means difference|-1.0|Standard Error of the Mean|1.48||0.5171|2-Sided|95.0|-3.9|2.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28|
1655764|NCT01617187|3047058|Superiority or Other||LS means difference|-0.5|Standard Error of the Mean|1.19||0.6589|2-Sided|95.0|-2.9|1.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28|
1655765|NCT01617187|3047058|Superiority or Other||LS means difference|1.8|Standard Error of the Mean|1.26||0.1548|2-Sided|95.0|-0.7|4.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28|
1655766|NCT01617187|3047058|Superiority or Other||LS means difference|-1.0|Standard Error of the Mean|1.38||0.4526|2-Sided|95.0|-3.7|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21|
1655767|NCT01617187|3047058|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|1.09||0.5075|2-Sided|95.0|-2.9|1.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1655768|NCT01617187|3047058|Superiority or Other||LS means difference|0.7|Standard Error of the Mean|1.15||0.5363|2-Sided|95.0|-1.5|3.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21|
1655769|NCT01617187|3047058|Superiority or Other||LS means difference|-1.0|Standard Error of the Mean|1.21||0.3907|2-Sided|95.0|-3.4|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14|
1655770|NCT01617187|3047058|Superiority or Other||LS means difference|-0.8|Standard Error of the Mean|0.95||0.3889|2-Sided|95.0|-2.7|1.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1655771|NCT01617187|3047058|Superiority or Other||LS means difference|0.2|Standard Error of the Mean|1.0||0.8079|2-Sided|95.0|-1.7|2.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14|
1655772|NCT01617187|3047058|Superiority or Other||LS means difference|-0.8|Standard Error of the Mean|1.18||0.4901|2-Sided|95.0|-3.1|1.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7|
1655773|NCT01617187|3047058|Superiority or Other||LS means difference|-1.4|Standard Error of the Mean|0.91||0.1391|2-Sided|95.0|-3.1|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1655774|NCT01617187|3047058|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.95||0.7907|2-Sided|95.0|-2.1|1.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7|
1655775|NCT01617187|3047058|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.83||0.952|2-Sided|95.0|-1.7|1.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4|
1655776|NCT01617187|3047058|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.65||0.703|2-Sided|95.0|-1.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4|
1655777|NCT01617187|3047058|Superiority or Other||LS means difference|0.2|Standard Error of the Mean|0.66||0.7819|2-Sided|95.0|-1.1|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4|
1655778|NCT01617187|3047059|Superiority or Other||LS means difference|-2.1|Standard Error of the Mean|1.03||0.0406|2-Sided|95.0|-4.1|-0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42|
1655779|NCT01617187|3047059|Superiority or Other||LS means difference|-1.8|Standard Error of the Mean|0.83||0.0306|2-Sided|95.0|-3.5|-0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42|
1655780|NCT01617187|3047059|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.88||0.8039|2-Sided|95.0|-2.0|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42|
1655781|NCT01617187|3047059|Superiority or Other||LS means difference|-1.4|Standard Error of the Mean|0.96||0.151|2-Sided|95.0|-3.3|0.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35|
1655782|NCT01617187|3047059|Superiority or Other||LS means difference|-0.9|Standard Error of the Mean|0.77||0.2698|2-Sided|95.0|-2.4|0.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35|
1655783|NCT01617187|3047059|Superiority or Other||LS means difference|0.3|Standard Error of the Mean|0.82||0.7284|2-Sided|95.0|-1.3|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35|
1655784|NCT01617187|3047059|Superiority or Other||LS means difference|-1.2|Standard Error of the Mean|0.94||0.2068|2-Sided|95.0|-3.1|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28|
1656152|NCT01608100|3047894|Superiority or Other||Percent Specificity|85.81|||||2-Sided|95.0|83.31|88.07||||||Time point: 2-4 hours|
1655785|NCT01617187|3047059|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.76||0.3516|2-Sided|95.0|-2.2|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28|
1655786|NCT01617187|3047059|Superiority or Other||LS means difference|0.9|Standard Error of the Mean|0.8||0.2643|2-Sided|95.0|-0.7|2.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28|
1655787|NCT01617187|3047059|Superiority or Other||LS means difference|-1.1|Standard Error of the Mean|0.86||0.1886|2-Sided|95.0|-2.8|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21|
1655788|NCT01617187|3047059|Superiority or Other||LS means difference|-0.5|Standard Error of the Mean|0.68||0.493|2-Sided|95.0|-1.8|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1655789|NCT01617187|3047059|Superiority or Other||LS means difference|0.5|Standard Error of the Mean|0.72||0.4575|2-Sided|95.0|-0.9|1.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21|
1655790|NCT01617187|3047059|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.74||0.3326|2-Sided|95.0|-2.2|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14|
1655791|NCT01617187|3047059|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.58||0.726|2-Sided|95.0|-1.3|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1655792|NCT01617187|3047059|Superiority or Other||LS means difference|0.3|Standard Error of the Mean|0.61||0.6267|2-Sided|95.0|-0.9|1.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14|
1655793|NCT01617187|3047059|Superiority or Other||LS means difference|-1.0|Standard Error of the Mean|0.66||0.1431|2-Sided|95.0|-2.3|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7|
1655794|NCT01617187|3047059|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.51||0.6917|2-Sided|95.0|-1.2|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1655795|NCT01617187|3047059|Superiority or Other||LS means difference|0.3|Standard Error of the Mean|0.53||0.6347|2-Sided|95.0|-0.8|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7|
1655796|NCT01617187|3047059|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.5||0.1834|2-Sided|95.0|-1.6|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4|
1655797|NCT01617187|3047059|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.39||0.9494|2-Sided|95.0|-0.7|0.8||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4|
1655798|NCT01617187|3047059|Superiority or Other||LS means difference|0.5|Standard Error of the Mean|0.4||0.216|2-Sided|95.0|-0.3|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4|
1655799|NCT01617187|3047060|Superiority or Other||LS means difference|-0.6|Standard Error of the Mean|0.84||0.4418|2-Sided|95.0|-2.3|1.0||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 42|
1655800|NCT01617187|3047060|Superiority or Other||LS means difference|-1.1|Standard Error of the Mean|0.69||0.1143|2-Sided|95.0|-2.4|0.3||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 42|
1655801|NCT01617187|3047060|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.73||0.8812|2-Sided|95.0|-1.5|1.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 42|
1655802|NCT01617187|3047060|Superiority or Other||LS means difference|-0.8|Standard Error of the Mean|0.77||0.3128|2-Sided|95.0|-2.3|0.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35|
1655803|NCT01617187|3047060|Superiority or Other||LS means difference|-0.8|Standard Error of the Mean|0.61||0.1908|2-Sided|95.0|-2.0|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35|
1655804|NCT01617187|3047060|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.65||0.315|2-Sided|95.0|-1.9|0.6||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35|
1655805|NCT01617187|3047060|Superiority or Other||LS means difference|0.4|Standard Error of the Mean|0.72||0.6282|2-Sided|95.0|-1.1|1.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28|
1655806|NCT01617187|3047060|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.58||0.7667|2-Sided|95.0|-1.3|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28|
1655807|NCT01617187|3047060|Superiority or Other||LS means difference|0.5|Standard Error of the Mean|0.61||0.4248|2-Sided|95.0|-0.7|1.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28|
1655808|NCT01617187|3047060|Superiority or Other||LS means difference|0.3|Standard Error of the Mean|0.68||0.6216|2-Sided|95.0|-1.0|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21|
1655809|NCT01617187|3047060|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.54||0.8077|2-Sided|95.0|-1.2|0.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1655810|NCT01617187|3047060|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.56||0.8839|2-Sided|95.0|-1.0|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21|
1655811|NCT01617187|3047060|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.62||0.9223|2-Sided|95.0|-1.2|1.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14|
1655812|NCT01617187|3047060|Superiority or Other||LS means difference|-0.6|Standard Error of the Mean|0.49||0.2504|2-Sided|95.0|-1.5|0.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1655813|NCT01617187|3047060|Superiority or Other||LS means difference|0.2|Standard Error of the Mean|0.51||0.6471|2-Sided|95.0|-0.8|1.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14|
1655814|NCT01617187|3047060|Superiority or Other||LS means difference|-0.5|Standard Error of the Mean|0.57||0.4025|2-Sided|95.0|-1.6|0.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7|
1655815|NCT01617187|3047060|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.44||0.528|2-Sided|95.0|-1.1|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1655816|NCT01617187|3047060|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.45||0.807|2-Sided|95.0|-1.0|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7|
1656080|NCT01610791|3047539|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Diffrence in total cholesterol from baseline to Week 24|
1655817|NCT01617187|3047060|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.5||0.783|2-Sided|95.0|-1.1|0.8||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4|
1655818|NCT01617187|3047060|Superiority or Other||LS means difference|0.2|Standard Error of the Mean|0.39||0.5488|2-Sided|95.0|-0.5|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4|
1655819|NCT01617187|3047060|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.4||0.8829|2-Sided|95.0|-0.7|0.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4|
1655820|NCT01617187|3047061|Superiority or Other|||||||0.004||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42|
1655821|NCT01617187|3047061|Superiority or Other|||||||0.5074||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42|
1655822|NCT01617187|3047061|Superiority or Other|||||||0.7129||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 42|
1655823|NCT01617187|3047061|Superiority or Other|||||||0.0132||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35|
1655824|NCT01617187|3047061|Superiority or Other|||||||0.9698||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35|
1655825|NCT01617187|3047061|Superiority or Other|||||||0.585||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35|
1655826|NCT01617187|3047061|Superiority or Other|||||||0.0859||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28|
1655827|NCT01617187|3047061|Superiority or Other|||||||0.8037||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28|
1655828|NCT01617187|3047061|Superiority or Other|||||||0.7482||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28|
1655829|NCT01617187|3047061|Superiority or Other|||||||0.0692||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21|
1655830|NCT01617187|3047061|Superiority or Other|||||||0.4875||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21|
1655831|NCT01617187|3047061|Superiority or Other|||||||0.5531||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21|
1655832|NCT01617187|3047061|Superiority or Other|||||||0.0762||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14|
1655833|NCT01617187|3047061|Superiority or Other|||||||0.3426||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14|
1655834|NCT01617187|3047061|Superiority or Other|||||||0.5088||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14|
1655835|NCT01617187|3047061|Superiority or Other|||||||0.117||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7|
1655836|NCT01617187|3047061|Superiority or Other|||||||0.969||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7|
1655837|NCT01617187|3047061|Superiority or Other|||||||0.4076||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7|
1655838|NCT01617187|3047061|Superiority or Other|||||||0.3945||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4|
1655839|NCT01617187|3047061|Superiority or Other|||||||0.4829||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4|
1655840|NCT01617187|3047061|Superiority or Other|||||||0.6205||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4|
1655841|NCT01617187|3047062|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.17||0.24|2-Sided|95.0|-0.5|0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35|
1655842|NCT01617187|3047062|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.14||0.1111|2-Sided|95.0|-0.5|0.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35|
1655843|NCT01617187|3047062|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.15||0.6682|2-Sided|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35|
1655844|NCT01617187|3047062|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.17||0.9901|2-Sided|95.0|-0.3|0.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28|
1655845|NCT01617187|3047062|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.13||0.482|2-Sided|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28|
1655846|NCT01617187|3047062|Superiority or Other||LS means difference|0.2|Standard Error of the Mean|0.14||0.2972|2-Sided|95.0|-0.1|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28|
1655847|NCT01617187|3047062|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.16||0.5683|2-Sided|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21|
1655848|NCT01617187|3047062|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.13||0.5318|2-Sided|95.0|-0.3|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1655849|NCT01617187|3047062|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.13||0.4188|2-Sided|95.0|-0.2|0.4||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21|
1655850|NCT01617187|3047062|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.14||0.5454|2-Sided|95.0|-0.4|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14|
1655851|NCT01617187|3047062|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.11||0.6359|2-Sided|95.0|-0.3|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1655852|NCT01617187|3047062|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|0.11||0.4671|2-Sided|95.0|-0.3|0.1||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14|
1655853|NCT01617187|3047062|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.12||0.9789|2-Sided|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7|
1655854|NCT01617187|3047062|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.09||0.9598|2-Sided|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1655855|NCT01617187|3047062|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.1||0.8759|2-Sided|95.0|-0.2|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7|
1655856|NCT01617187|3047062|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.08||0.6363|2-Sided|95.0|-0.2|0.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4|
1655857|NCT01617187|3047062|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.06||0.9564|2-Sided|95.0|-0.1|0.1||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4|
1655858|NCT01617187|3047062|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.07||0.4255|2-Sided|95.0|-0.1|0.2||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4|
1655859|NCT01617187|3047063|Superiority or Other|||||||0.799||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35|
1655860|NCT01617187|3047063|Superiority or Other|||||||0.1954||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35|
1655861|NCT01617187|3047063|Superiority or Other|||||||0.4892||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 35|
1655862|NCT01617187|3047063|Superiority or Other|||||||0.6953||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28|
1655863|NCT01617187|3047063|Superiority or Other|||||||0.2894||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28|
1655864|NCT01617187|3047063|Superiority or Other|||||||0.437||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 28|
1655865|NCT01617187|3047063|Superiority or Other|||||||0.9189||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21|
1655866|NCT01617187|3047063|Superiority or Other|||||||0.4834||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21|
1655867|NCT01617187|3047063|Superiority or Other|||||||0.2447||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 21|
1655868|NCT01617187|3047063|Superiority or Other|||||||0.6604||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14|
1655869|NCT01617187|3047063|Superiority or Other|||||||0.9704||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14|
1655870|NCT01617187|3047063|Superiority or Other|||||||0.6804||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 14|
1655871|NCT01617187|3047063|Superiority or Other|||||||0.1105||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7|
1655872|NCT01617187|3047063|Superiority or Other|||||||0.6938||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7|
1655873|NCT01617187|3047063|Superiority or Other|||||||0.329||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 7|
1655874|NCT01617187|3047063|Superiority or Other|||||||0.285||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4|
1655875|NCT01617187|3047063|Superiority or Other|||||||0.1736||||||P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4|
1655876|NCT01617187|3047063|Superiority or Other|||||||0.1736||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Day 4|
1655877|NCT01617187|3047064|Superiority or Other||LS means difference|-4.9|Standard Error of the Mean|2.68||0.0675|2-Sided|95.0|-10.2|0.4||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 35|
1655878|NCT01617187|3047064|Superiority or Other||LS means difference|-3.6|Standard Error of the Mean|2.14||0.0947|2-Sided|95.0|-7.8|0.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 35|
1655879|NCT01617187|3047064|Superiority or Other||LS means difference|-1.6|Standard Error of the Mean|2.26||0.4697|2-Sided|95.0|-6.1|2.8||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 35|
1655880|NCT01617187|3047064|Superiority or Other||LS means difference|-1.8|Standard Error of the Mean|2.71||0.4961|2-Sided|95.0|-7.2|3.5||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 28|
1655881|NCT01617187|3047064|Superiority or Other||LS means difference|-1.6|Standard Error of the Mean|2.17||0.4682|2-Sided|95.0|-5.8|2.7||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 28|
1655882|NCT01617187|3047064|Superiority or Other||LS means difference|3.2|Standard Error of the Mean|2.3||0.1691|2-Sided|95.0|-1.4|7.7||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 28|
1655883|NCT01617187|3047064|Superiority or Other||LS means difference|-2.0|Standard Error of the Mean|2.56||0.4423|2-Sided|95.0|-7.0|3.1||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 21|
1655884|NCT01617187|3047064|Superiority or Other||LS means difference|-1.6|Standard Error of the Mean|2.03||0.4286|2-Sided|95.0|-5.6|2.4||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1655885|NCT01617187|3047064|Superiority or Other||LS means difference|1.3|Standard Error of the Mean|2.13||0.5505|2-Sided|95.0|-2.9|5.5||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 21|
1655886|NCT01617187|3047064|Superiority or Other||LS means difference|-1.7|Standard Error of the Mean|2.18||0.4261|2-Sided|95.0|-6.0|2.6||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 14|
1655887|NCT01617187|3047064|Superiority or Other||LS means difference|-1.8|Standard Error of the Mean|1.72||0.2895|2-Sided|95.0|-5.2|1.6||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1655888|NCT01617187|3047064|Superiority or Other||LS means difference|0.7|Standard Error of the Mean|1.79||0.6773|2-Sided|95.0|-2.8|4.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 14|
1655889|NCT01617187|3047064|Superiority or Other||LS means difference|-2.2|Standard Error of the Mean|2.0||0.271|2-Sided|95.0|-6.2|1.7||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 7|
1655890|NCT01617187|3047064|Superiority or Other||LS means difference|-2.0|Standard Error of the Mean|1.56||0.1902|2-Sided|95.0|-5.1|1.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1655891|NCT01617187|3047064|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|1.61||0.9271|2-Sided|95.0|-3.3|3.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 7|
1655892|NCT01617187|3047064|Superiority or Other||LS means difference|-0.8|Standard Error of the Mean|1.36||0.5826|2-Sided|95.0|-3.4|1.9||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID|Day 4|
1655893|NCT01617187|3047064|Superiority or Other||LS means difference|-0.1|Standard Error of the Mean|1.06||0.8902|2-Sided|95.0|-2.2|1.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4|
1655894|NCT01617187|3047064|Superiority or Other||LS means difference|0.8|Standard Error of the Mean|1.09||0.4849|2-Sided|95.0|-1.4|2.9||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Day 4|
1655895|NCT01617187|3047065|Superiority or Other||LS means difference|2.2|Standard Error of the Mean|0.58||0.0003|2-Sided|95.0|1.0|3.3||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID||
1655896|NCT01617187|3047065|Superiority or Other||LS means difference|1.0|Standard Error of the Mean|0.48||0.0391|2-Sided|95.0|0.0|1.9||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID||
1655897|NCT01617187|3047065|Superiority or Other||LS means difference|1.0|Standard Error of the Mean|0.51||0.0567|2-Sided|95.0|0.0|2.0||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID||
1655898|NCT01617187|3047065|Superiority or Other||LS means difference|-1.2|Standard Error of the Mean|0.57||0.0491|2-Sided|95.0|-2.3|0.0||p-value adjusted for multiple comparisons using Hochberg's method|MMRM||Asenapine 5 mg BID minus Olanzapine 15 mg QD||
1655899|NCT01617187|3047065|Superiority or Other||LS means difference|-1.2|Standard Error of the Mean|0.6||0.0491|2-Sided|95.0|-2.4|0.0||p-value adjusted for multiple comparisons using Hochberg's method|MMRM||Asenapine 2.5 mg BID minus Olanzapine 15 mg QD||
1655900|NCT01617187|3047066|Superiority or Other|||||||0.262||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel||||
1655901|NCT01617187|3047066|Superiority or Other|||||||0.1708||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)|
1655902|NCT01617187|3047066|Superiority or Other|||||||0.37||||||P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center|Cochran-Mantel-Haenszel|||Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)|
1655903|NCT01617187|3047067|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.18||0.3898|2-Sided|95.0|-0.5|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID||
1655904|NCT01617187|3047067|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.14||0.0601|2-Sided|95.0|-0.6|0.0||Unadjusted p-value|MMRM||Asenapine 5 mg BID minus Placebo BID|Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)|
1655905|NCT01617187|3047067|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.15||0.9083|2-Sided|95.0|-0.3|0.3||Unadjusted p-value|MMRM||Asenapine 2.5 mg BID minus Placebo BID|Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure)|
1655906|NCT01617187|3047068|Superiority or Other||LS means difference|-5.4|Standard Error of the Mean|2.86||0.0587|2-Sided|95.0|-11.1|0.2||Unadjusted p-value|MMRM||Olanzapine 15 mg BID minus Placebo BID||
1655907|NCT01617187|3047068|Superiority or Other||LS means difference|-5.5|Standard Error of the Mean|2.32||0.0356|2-Sided|95.0|-10.1|-1.0||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID||
1655908|NCT01617187|3047068|Superiority or Other||Least Squares (LS) means difference|-1.3|Standard Error of the Mean|2.46||0.6043|2-Sided|95.0|-6.1|3.6||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary efficacy hypotheses|Mixed Model Repeated Measures (MMRM)||Asenapine 2.5 mg BID minus Placebo BID||
1655909|NCT01617148|3047073|Superiority or Other|||||||0.038|||||||t-test, 2 sided||||
1655910|NCT01617148|3047074|Superiority or Other|||||||0.038|||||||t-test, 2 sided||||
1655911|NCT01617148|3047075|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1655912|NCT01617148|3047076|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1655913|NCT01616771|3047089|Superiority or Other||||||<|0.05||||||To verify the difference in C&L grades using each blade, the ordinal scales of each blade were compared using the Wilcoxon signed rank test. P values and confidence intervals have been corrected for the 3 comparisons.|Wilcoxon (Mann-Whitney)|Hodges–Lehmann method was used to calculate 98.3% CIs of paired differences of 3 comparisons.||An improvement of C&L grade ordinal scale by 2 was considered a clinically significant change. The mean difference of C&L grade ordinal scale between DL and GVLw was 1.3, and its standard deviation was 2.0 in our pilot study. The required sample size for the Wilcoxon signed rank test was 21 with an α error of 0.05 and 80% power.|
1655981|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.89|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B|
1656081|NCT01610791|3047540|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Difference in AST from Baseline to Week 24|
1655914|NCT01616771|3047090|Superiority or Other||||||<|0.05||||||To verify the difference in C&L grades using each blade, the ordinal scales of each blade were compared using the Wilcoxon signed rank test. P values and confidence intervals have been corrected for the 3 comparisons.|Wilcoxon (Mann-Whitney)|Hodges–Lehmann method was used to calculate 98.3% CIs of paired differences of 3 comparisons.||An improvement of C&L grade ordinal scale by 2 was considered a clinically significant change. The mean difference of C&L grade ordinal scale between DL and GVLw was 1.3, and its standard deviation was 2.0 in our pilot study. The required sample size for the Wilcoxon signed rank test was 21 with an α error of 0.05 and 80% power.|
1655915|NCT01616693|3047094|Superiority||Mean Difference (Net)|-2.0|||||2-Sided|95.0|-9.8|5.7|||||||
1655916|NCT01616693|3047094|Superiority||Mean Difference (Net)|-3.1|||||2-Sided|95.0|-8.6|2.3|||||||
1655917|NCT01616693|3047094|Superiority||Mean Difference (Net)|1.1|||||2-Sided|95.0|-4.3|6.6|||||||
1655918|NCT01616693|3047096|Superiority||Difference in seroconversion proportion|12.0|||||2-Sided|95.0|0.8|22.8|||||||
1655919|NCT01616693|3047096|Superiority||Difference in seroconversion proportion|7.5|||||2-Sided|95.0|-1.4|16.2|||||||
1655920|NCT01616693|3047096|Superiority||Difference in seroconversion proportion|4.4|||||2-Sided|97.5|-4.4|13.2|||||||
1655921|NCT01616459|3047119|Non-Inferiority or Equivalence|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe,1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|3.75|||||2-Sided|95.8|1.03|7.57||||||ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A & 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups <10% for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655922|NCT01616459|3047119|Non-Inferiority or Equivalence|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe,1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|11.22|||||2-Sided|95.8|7.22|16.49||||||ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A & 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups <10% for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655923|NCT01616459|3047120|Non-Inferiority or Equivalence|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe,1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|2.5|||||2-Sided|95.8|-5.07|10.06||||||ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups < 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655924|NCT01616459|3047120|Non-Inferiority or Equivalence|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe,1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.98|||||2-Sided|95.8|-4.38|2.1||||||ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups < 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655925|NCT01616459|3047120|Non-Inferiority or Equivalence|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe,1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.5|||||2-Sided|95.8|-3.72|2.52||||||ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups < 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655982|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.89|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B|
1656082|NCT01610791|3047540|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Difference in ALT from Baseline to Week 24|
1655926|NCT01616459|3047120|Non-Inferiority or Equivalence|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe,1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.0|||||2-Sided|95.8|-1.94|1.9||||||ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups < 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655927|NCT01616459|3047120|Non-Inferiority or Equivalence|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe,1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.02|||||2-Sided|95.8|-2.72|2.64||||||ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups < 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655928|NCT01616459|3047120|Non-Inferiority or Equivalence|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe,1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.46|||||2-Sided|95.8|-1.93|3.06||||||ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups < 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655929|NCT01616459|3047120|Non-Inferiority or Equivalence|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe,1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-4.67|||||2-Sided|95.8|-12.94|3.6||||||ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups < 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655930|NCT01616459|3047120|Non-Inferiority or Equivalence|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe,1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.01|||||2-Sided|95.8|-2.37|2.3||||||ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups < 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655931|NCT01616459|3047120|Non-Inferiority or Equivalence|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe,1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.06|||||2-Sided|95.8|-4.03|3.86||||||ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups < 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655939|NCT01616459|3047122|Non-Inferiority or Equivalence|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe, 1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.03|||||2-Sided|95.9|-2.39|2.21||||||ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups < 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655932|NCT01616459|3047120|Non-Inferiority or Equivalence|Objectives for 12-valent formulation were to be assessed sequentially after demonstration of objectives for 11-valent formulation. 2-sided 95.8% Confidence Interval (CI) adjusted 1-sided (alpha =2.08%) of the difference between groups in terms of percentage of subjects. CI for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe,1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.49|||||2-Sided|95.8|-3.44|2.22||||||ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups < 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655933|NCT01616459|3047121|Non-Inferiority or Equivalence|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe, 1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.89|||||2-Sided|95.9|-1.46|3.66||||||ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups < 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655934|NCT01616459|3047122|Non-Inferiority or Equivalence|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe, 1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|2.73|||||2-Sided|95.9|-4.84|10.25||||||ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups < 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655935|NCT01616459|3047122|Non-Inferiority or Equivalence|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe, 1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-2.38|||||2-Sided|95.9|-5.64|-0.52||||||ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups < 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655936|NCT01616459|3047122|Non-Inferiority or Equivalence|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe, 1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-1.0|||||2-Sided|95.9|-4.18|1.7||||||ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups < 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655937|NCT01616459|3047122|Non-Inferiority or Equivalence|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe, 1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.45|||||2-Sided|95.9|-1.51|2.66||||||ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups < 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655938|NCT01616459|3047122|Non-Inferiority or Equivalence|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe, 1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|0.4|||||2-Sided|95.9|-2.36|3.22||||||ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups < 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655977|NCT01614899|3047210|Superiority||LS Mean difference|-0.18||||0.199|2-Sided|95.0|-0.453|0.095|||Mixed Model for Repeated Measures||||
1655978|NCT01614899|3047210|Superiority||LS Mean difference|-0.08||||0.594|2-Sided|95.0|-0.354|0.203|||Mixed Model for Repeated Measures||||
1655979|NCT01614899|3047211|Superiority||LS Mean difference|-4.2||||0.08|2-Sided|95.0|-8.91|0.5|||Mixed Model for Repeated Measures||||
1655940|NCT01616459|3047122|Non-Inferiority or Equivalence|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe, 1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-2.24|||||2-Sided|95.9|-10.65|6.13||||||ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups < 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655941|NCT01616459|3047122|Non-Inferiority or Equivalence|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe, 1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.48|||||2-Sided|95.9|-2.82|1.38||||||ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups < 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655942|NCT01616459|3047122|Non-Inferiority or Equivalence|2-sided 95.9% Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe, 1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-1.08|||||2-Sided|95.9|-4.94|2.45||||||ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups < 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655943|NCT01616459|3047122|Non-Inferiority or Equivalence|2-sided 95.9 % Confidence Interval (CI) adjusted 1-sided (alpha = 2.05 %) of the difference between groups in terms of percentage of subjects. Confidence Interval (CI) for difference in proportion: Proc StatXact was used to derive the standardized asymptotic CI for the group difference in proportions [Newcombe, 1998]. The standardized asymptotic method used within GSK Biologicals is method 6.|Difference in percentage|-0.98|||||2-Sided|95.9|-3.89|1.36||||||ANTI-1 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups < 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655944|NCT01616459|3047123|Non-Inferiority or Equivalence|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.19 in 12Pn Group and N= 206 and Adj. GMC= 2.76 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|2.32|||||2-Sided|95.8|1.94|2.77||||||ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups < a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655945|NCT01616459|3047123|Non-Inferiority or Equivalence|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=210 and Adj. GMC =1.09 in 12Pn Group and N= 214 and Adj. GMC= 2.07 for Prevnar13 Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.9|||||2-Sided|95.8|1.51|2.39||||||ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups < a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655946|NCT01616459|3047123|Non-Inferiority or Equivalence|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.68 in 12Pn Group and N= 199 and Adj. GMC= 0.71 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI..|Adjusted GMCs ratio|1.05|||||2-Sided|95.8|0.81|1.37||||||ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A & 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups < a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655980|NCT01614899|3047211|Superiority||LS Mean difference|-4.8||||0.05|2-Sided|95.0|-9.52|0.0|||Mixed Model for Repeated Measures||||
1656011|NCT01614470|3047259|Superiority or Other||LS mean difference|0.6624|||<|0.0001|2-Sided|95.0|0.3366|0.9881|||Mixed Models Analysis||||
1657007|NCT01597245|3049339|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1655947|NCT01616459|3047123|Non-Inferiority or Equivalence|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =3.29 in 12Pn Group and N= 202 and Adj. GMC= 3.67 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.12|||||2-Sided|95.8|0.9|1.38||||||ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A & 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups < a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655948|NCT01616459|3047123|Non-Inferiority or Equivalence|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =2.55 in 12Pn Group and N= 201 and Adj. GMC= 2.57 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|1.01|||||2-Sided|95.8|0.81|1.26||||||ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A & 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups < a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655949|NCT01616459|3047123|Non-Inferiority or Equivalence|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=209 and Adj. GMC =4.48 in 12Pn Group and N= 201 and Adj. GMC= 4.10 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.91|||||2-Sided|95.8|0.77|1.09||||||ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A & 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups < a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655950|NCT01616459|3047123|Non-Inferiority or Equivalence|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.78 in 12Pn Group and N= 200 and Adj. GMC= 1.40 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.79|||||2-Sided|95.8|0.67|0.93||||||ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A & 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups < a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655951|NCT01616459|3047123|Non-Inferiority or Equivalence|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=211 and Adj. GMC =2.42 in 12Pn Group and N= 202 and Adj. GMC= 2.17 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.9|||||2-Sided|95.8|0.76|1.06||||||ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A & 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups < a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655952|NCT01616459|3047123|Non-Inferiority or Equivalence|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =0.56 in 12Pn Group and N= 200 and Adj. GMC= 0.47 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.84||||||95.8|0.64|1.11||||||ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A & 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups < a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655953|NCT01616459|3047123|Non-Inferiority or Equivalence|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =2.37 in 12Pn Group and N= 201 and Adj. GMC= 2.16 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.91|||||2-Sided|95.8|0.78|1.07||||||ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A & 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups < a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655954|NCT01616459|3047123|Non-Inferiority or Equivalence|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=208 and Adj. GMC =1.94 in 12Pn Group and N= 203 and Adj. GMC= 1.66 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.86||||||95.8|0.7|1.05||||||ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A & 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups < a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655955|NCT01616459|3047123|Non-Inferiority or Equivalence|12-valent formulation objectives to be assessed sequentially after demonstration for 11-valent formulation. GMCs ratio and its CI obtained using ANCOVA model on logarithm-transformed concentrations, including vaccine group as fixed effect and pre-vaccination concentration as regressor. GMCs were used to calculate Adjusted GMCs (N=207 and Adj. GMC =1.58 in 12Pn Group and N= 203 and Adj. GMC= 1.35 for Synflorix Group) which in turn were used to calculate Adjusted GMC ratio with 95.8% CI.|Adjusted GMCs ratio|0.86||||||95.8|0.72|1.02||||||ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A & 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups < a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.|
1655956|NCT01616459|3047123|Non-Inferiority or Equivalence|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations/titres, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=217 and Adjusted GMC =1.61 in the 11Pn Group and N= 206 and Adjusted GMC= 2.75 for the Prevnar13 Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.71|||||2-Sided|95.9|1.44|2.03||||||ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups < a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655957|NCT01616459|3047123|Non-Inferiority or Equivalence|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 0.62 in the 11Pn Group and N= 199 and Adjusted GMC= 0.71 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.15|||||2-Sided|95.9|0.89|1.48||||||ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups < a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655958|NCT01616459|3047123|Non-Inferiority or Equivalence|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 3.70 in the 11Pn Group and N= 202 and Adjusted GMC= 3.68 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|1.0|||||2-Sided|95.9|0.81|1.23||||||ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups < a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655959|NCT01616459|3047123|Non-Inferiority or Equivalence|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =2.81 in the 11Pn Group and N= 201 and Adjusted GMC= 2.57 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.92|||||2-Sided|95.9|0.74|1.14||||||ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups < a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655960|NCT01616459|3047123|Non-Inferiority or Equivalence|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 4.22 in the 11Pn Group and N= 201 and Adjusted GMC= 4.06 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.96|||||2-Sided|95.9|0.81|1.15||||||ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups < a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.|
1656012|NCT01614470|3047260|Superiority or Other||Least squares (LS) mean difference|10.678|||<|0.0001|2-Sided|95.0|7.2559|14.1|||Mixed Models Analysis||||
1657008|NCT01597245|3049339|Superiority or Other||||||<|0.005|||||||Cochran-Mantel-Haenszel||||
1655961|NCT01616459|3047123|Non-Inferiority or Equivalence|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.56 in the 11Pn Group and N= 200 and Adjusted GMC= 1.40 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.89|||||2-Sided|95.9|0.76|1.06||||||ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups < a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655962|NCT01616459|3047123|Non-Inferiority or Equivalence|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=219 and Adjusted GMC =2.30 in the 11Pn Group and N= 202 and Adjusted GMC= 2.17 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.94|||||2-Sided|95.9|0.81|1.1||||||ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups < a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655963|NCT01616459|3047123|Non-Inferiority or Equivalence|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =0.51 in the 11Pn Group and N= 200 and Adjusted GMC= 0.47 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.93|||||2-Sided|95.9|0.71|1.23||||||ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups < a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655964|NCT01616459|3047123|Non-Inferiority or Equivalence|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC = 2.46 in the 11Pn Group and N= 201 and Adjusted GMC= 2.16 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.88|||||2-Sided|95.9|0.75|1.03||||||ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups < a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655965|NCT01616459|3047123|Non-Inferiority or Equivalence|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.77 in the 11Pn Group and N= 203 and Adjusted GMC= 1.66 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.94|||||2-Sided|95.9|0.77|1.14||||||ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups < a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655966|NCT01616459|3047123|Non-Inferiority or Equivalence|GMCs ratio and its CI were calculated using an ANCOVA model on the logarithm-transformed concentrations, including the vaccine group as fixed effect and the pre-vaccination concentration as regressor. The GMCs were used to calculate the Adjusted GMCs (N=218 and Adjusted GMC =1.51 in the 11Pn Group and N= 203 and Adjusted GMC= 1.36 for the Synflorix Group) which in turn were used to calculate the Adjusted GMC ratio with 95.9% confidence interval.|Adjusted GMCs ratio|0.9|||||2-Sided|95.9|0.75|1.07||||||ANTI-1 serotype test :to demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups < a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.|
1655967|NCT01616056|3047130|Superiority|||||||0.005|||||||Wilcoxon (Mann-Whitney)||||
1655968|NCT01616056|3047133|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1655969|NCT01616056|3047135|Superiority|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1655970|NCT01616056|3047137|Superiority|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1655971|NCT01614899|3047207|Superiority||LS Mean difference|-1.6||||0.174|2-Sided|95.0|-3.93|0.72|||Mixed Model for Repeated Measures||||
1655972|NCT01614899|3047207|Superiority||LS Mean difference|-2.5||||0.036|2-Sided|95.0|-4.87|-0.17|||Mixed Model for Repeated Measures||||
1655973|NCT01614899|3047208|Superiority||LS Mean difference|-0.5||||0.388|2-Sided|95.0|-1.8|0.7|||Mixed Model for Repeated Measures||||
1655974|NCT01614899|3047208|Superiority||LS Mean difference|-1.0||||0.116|2-Sided|95.0|-2.27|0.25|||Mixed Model for Repeated Measures||||
1655975|NCT01614899|3047209|Superiority||LS Mean difference|-1.9||||0.01|2-Sided|95.0|-3.4|-0.46|||Mixed Model for Repeated Measures||||
1655976|NCT01614899|3047209|Superiority||LS Mean difference|-1.1||||0.143|2-Sided|95.0|-2.6|0.38|||Mixed Model for Repeated Measures||||
1655983|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.73|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B|
1655984|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.15|||||||Wilcoxon (Mann-Whitney)|df-=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B|
1655985|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.2|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B|
1655986|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.04|||||||Wilcoxon (Mann-Whitney)|df=14||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B|
1655987|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.64|||||||Wilcoxon (Mann-Whitney)|df=12||Comparison of Drop A versus Drop B change in osmolarity at this point in time. H0: No difference in osmolarity change between Drop A and B (Drop A = Drop B) H1: Significant difference in osmolarity change between Drop A and Drop B|
1655988|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.107|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)|
1655989|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.672|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)|
1655990|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.383|||||||Wilcoxon (Mann-Whitney)|df=7||Mean change in osmolarity from baseline. H0: No change (e.g. mean change = 0) H1: Significant change (mean change ≠ 0)|
1655991|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.383||||||Alpha = 0.05|Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)|
1655992|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.945||||||df=7|Wilcoxon (Mann-Whitney)|||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)|
1655993|NCT01614847|3047217|Equivalence|Alpha = 0.05||||||0.844|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)|
1655994|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.945|||||||Wilcoxon (Mann-Whitney)|df=7||Drop B: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)|
1655995|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.055|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)|
1655996|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.726|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)|
1655997|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.15|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)|
1655998|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.262|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)|
1655999|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.779|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)|
1656000|NCT01614847|3047217|Equivalence|two-tailed, alpha = 0.05||||||0.109|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)|
1656001|NCT01614847|3047217|Equivalence|Two tailed, alpha = 0.05||||||0.4|||||||Wilcoxon (Mann-Whitney)|df=7||Drop A: Mean change in osmolarity from baseline H0: No osmolarity change from baseline (e.g. mean change = 0) H1: Significant osmolarity change from baseline (mean change ≠ 0)|
1656002|NCT01614769|3047229|Superiority or Other||Mean Difference (Final Values)|-7.27|||||2-Sided|90.0|-13.3|-1.24|||||||
1656003|NCT01614769|3047229|Superiority or Other||Mean Difference (Final Values)|-5.03|||||2-Sided|90.0|-11.12|1.05|||||||
1656004|NCT01614769|3047230|Superiority or Other||Mean Difference (Final Values)|-0.13|||||2-Sided|90.0|-0.24|-0.03|||||||
1656005|NCT01614769|3047230|Superiority or Other||Mean Difference (Final Values)|-0.1|||||2-Sided|90.0|-0.21|0.0|||||||
1656006|NCT01614769|3047231|Superiority or Other||Mean Difference (Final Values)|35.33|||||2-Sided|90.0|-2.08|72.74|||||||
1656007|NCT01614769|3047231|Superiority or Other||Mean Difference (Final Values)|14.41|||||2-Sided|90.0|-22.98|51.8|||||||
1656008|NCT01614509|3047249|Non-Inferiority or Equivalence|Central retinal thickness was measured using an optical coherence tomography by every visit intended for all participants.||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Central retinal thickness was measured using an optical coherence tomography by every visit. And we compare the difference of central retinal thickness between two groups|
1656009|NCT01614470|3047254|Superiority or Other||LS mean difference|9.6105||||0.0004|2-Sided|95.0|4.4874|14.7336|||Mixed Models Analysis||||
1656010|NCT01614470|3047257|Superiority or Other||LS mean difference|-49.1667|||<|0.0001|2-Sided|95.0|-56.9527|-41.3807|||Mixed Models Analysis||||
1656014|NCT01614457|3047263|Superiority or Other||LS Mean difference|8.3874||||0.0091|2-Sided|95.0|2.1658|14.609|||Mixed Model Repeated Measures|||Analysis was based on MMRM with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, and CFQ-R respiratory domain score, using compound symmetry covariance matrix.|
1656015|NCT01614457|3047264|Superiority or Other||LS Mean difference|-23.9693|||<|0.0001|2-Sided|95.0|-28.0094|-19.9293|||Mixed Model Repeated Measures|||Analysis was based on MMRM with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, and sweat chloride, using a compound symmetry covariance matrix.|
1656016|NCT01614457|3047265|Superiority or Other||LS Mean difference|0.2626||||0.778|2-Sided|95.0|-1.5698|2.095||p-value for the treatment effect is from the slope of BMI (kg/m2) versus time (days).|Linear Mixed model|||Analysis was based on linear mixed model with dependent variable BMI and treatment as a fixed effect, adjustment for baseline percent predicted FEV1, age and visit by treatment interaction was included as covariates and intercept, visit were included as random effects.|
1656017|NCT01614457|3047266|Superiority or Other||Least squares (LS) Mean Difference|2.1114||||0.1979|2-Sided|95.0|-1.1305|5.3532|||Mixed Model Repeated Measures|||Analysis was based on mixed effects model for repeated measures (MMRM) with dependent variable absolute change from baseline, with treatment group, visit and treatment by visit interaction as fixed effects, subject as random effect, and with adjustment for the continuous baseline value of age and percent predicted FEV1, using compound symmetry covariance matrix.|
1656018|NCT01614249|3047268|Superiority or Other||Slope|1.01|Standard Error of the Mean|0.8||0.21|2-Sided|95.0|-0.58|2.6||The p-value was adjusted for baseline variations in the analysis of covariance (ANCOVA) regression model. The significance level was set at p-value less than 0.05.|ANCOVA|In ANCOVA, fish oil group was main effect, participant baseline variables were covariates and presence of interaction between covariates was tested.||Null hypothesis: There is no difference in the magnitude of change in BDI-II scores between HIV–seropositive pregnant women on fish oil omega-3 EPA-rich supplements and the control group on soybean oil soft gels. A sample size of 91 women per arm gave an 85% power to detect as statistically significant at 5% level, a true difference of 4 scores in the mean depressive symptom scores between the two arms assuming a within group standard deviation of nine in depressive symptom scores.|
1656019|NCT01614210|3047273|Other|||||||0.0001|||||||t-test, 1 sided||||
1656020|NCT01613417|3047292|Superiority or Other|||||||0.0124|||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization|
1656021|NCT01613417|3047292|Superiority or Other|||||||0.1317|||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization|
1656022|NCT01613417|3047292|Superiority or Other|||||||0.6949|||||||McNemar|||McNemar test of difference (ProHance minus Gadovist/Gadavist) in accuracy for tumor characterization|
1656023|NCT01613417|3047293|Superiority or Other|||||||0.0455|||||||McNemar||||
1656024|NCT01613417|3047293|Superiority or Other|||||||0.5637|||||||McNemar||||
1656025|NCT01613417|3047293|Superiority or Other|||||||0.3173|||||||McNemar||||
1656026|NCT01613417|3047294|Superiority or Other|||||||0.7722|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.|||
1656027|NCT01613417|3047294|Superiority or Other|||||||0.4514|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.|||
1656028|NCT01613417|3047294|Superiority or Other|||||||0.6201|||||||Mixed Models Analysis|Investigation product (IP) effect from mixed model with period, sequence, and IP as fixed effects and subject nested within sequence as random effect.|||
1656029|NCT01613417|3047295|Superiority or Other|||||||0.5267|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect|||
1656030|NCT01613417|3047295|Superiority or Other|||||||0.0676|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect|||
1656031|NCT01613417|3047295|Superiority or Other|||||||0.2758|||||||Mixed Models Analysis|Mixed effect model with period, sequence, and IP and fixed effect and subject nested within sequence as random effect|||
1656032|NCT01613417|3047296|Superiority or Other|||||||1||||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||||
1656033|NCT01613417|3047296|Superiority or Other|||||||1||||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||||
1656034|NCT01613417|3047296|Superiority or Other|||||||1||||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||||
1656035|NCT01613417|3047297|Superiority or Other|||||||1||||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||||
1656036|NCT01613417|3047297|Superiority or Other|||||||1||||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||||
1656037|NCT01613417|3047297|Superiority or Other|||||||1||||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||||
1656038|NCT01613417|3047298|Superiority or Other|||||||1||||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||||
1656039|NCT01613417|3047298|Superiority or Other|||||||0.6875||||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||||
1656040|NCT01613417|3047298|Superiority or Other|||||||1||||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||||
1656041|NCT01613417|3047299|Superiority or Other|||||||1||||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||||
1656042|NCT01613417|3047299|Superiority or Other|||||||1||||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||||
1656043|NCT01613417|3047299|Superiority or Other|||||||1||||||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||||
1656149|NCT01608100|3047893|Superiority or Other||Negative Predictive Value|99.19|||||2-Sided|95.0|98.25|99.7||||||Time point: 2-4 hours|
1656150|NCT01608100|3047893|Superiority or Other||Negative Predictive Value|98.1|||||2-Sided|95.0|96.82|98.95||||||Time point: 0-2 hours|
1656044|NCT01613417|3047300|Non-Inferiority or Equivalence|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.5||||1|2-Sided|95.0|-0.5|1.5||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)||
1656045|NCT01613417|3047300|Non-Inferiority or Equivalence|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.0||||1|2-Sided|95.0|-3.8|3.8||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)||
1656046|NCT01613417|3047300|Non-Inferiority or Equivalence|Power calculation was based on primary endpoint. 185 patients were deemed necessary for the lower limit of the observed 2-sided 95% confidence interval for the difference to exceed -5% with 85% power.|Percentage PH better minus GV better|0.5||||0.8516|2-Sided|95.0|-4.6|5.6||P-value from Wilcoxon signed-rank test|Wilcoxon (Mann-Whitney)||Difference in percentage ProHance better minus percentage Gadovist/Gadavist better (%)||
1656047|NCT01613313|3047330|Superiority or Other||Mean Difference (Final Values)|50.0|||||2-Sided|||||||||This is a proof of concept dose escalation study. No power of justification was implemented. Descriptive statistics was provided for each arm only.|
1656048|NCT01613313|3047331|Superiority or Other||Mean Difference (Final Values)|50.0|||||2-Sided|||||||||This is a proof of concept dose escalation study. No power justification has been implemented. Descriptive data provided for each arm.|
1656049|NCT01613027|3047375|Superiority or Other||||||<|0.001|||||||Paired t-test|||Difference in change at Month 12|
1656050|NCT01613027|3047375|Superiority or Other||||||<|0.001|||||||Paired t-test|||Difference in change at Month 6|
1656051|NCT01612884|3047377|Other|Chi-Square|||||>|0.05|||||||Chi-squared||||
1656052|NCT01612884|3047378|Other|Chi-Square||||||0.93|||||||Chi-squared||||
1656053|NCT01612884|3047379|Other|Student's T-test||||||0.85|||||||t-test, 2 sided||||
1656054|NCT01612546|3047417|Other||||||<|0.01|||||||Fisher Exact||||
1656055|NCT01612221|3047430|Superiority|||||||0.27|||||||ANCOVA|||SLC7A11 Biomarker analysis.|
1656056|NCT01612221|3047430|Superiority|||||||0.63|||||||ANCOVA|||SLC1A4 Biomarker analysis.|
1656057|NCT01612221|3047430|Superiority|||||||0.76|||||||ANCOVA|||GCLM Biomarker analysis.|
1656058|NCT01612221|3047431|Superiority|||||||0.65|||||||Wilcoxon (Mann-Whitney)||||
1656059|NCT01611883|3047452|Superiority or Other||Difference in Least-squares Means|-19.07|||<|0.001|2-Sided|95.0|-22.71|-15.43|||Longitudinal Analysis of Covariance|Treatment group, HbA1c level, insulin use, time, and “time × treatment group” interaction as factors, and baseline as covariate|ezetimibe minus placebo||
1656060|NCT01611883|3047453|Superiority or Other||Difference in Least-squares Means|2.45||||0.246|2-Sided|95.0|-1.71|6.61|||Longitudinal Analysis of Covariance|Treatment group, HbA1c level, insulin use, time, and “time × treatment group” interaction as factors, and baseline as covariate|ezetimibe minus placebo||
1656061|NCT01611883|3047454|Superiority or Other||Difference in Least-squares Means|-11.36||||0.025|2-Sided|95.0|-21.27|-1.44|||Longitudinal Analysis of Covariance|Treatment group, HbA1c level, insulin use, time, and “time × treatment group” interaction as factors, and baseline as covariate|ezetimibe minus placebo||
1656062|NCT01611883|3047455|Superiority or Other||Difference in Least-squares Means|-13.54|||<|0.001|2-Sided|95.0|-16.66|-10.42|||Longitudinal analysis of covariance|Treatment group, HbA1c level, insulin use, time, and “time × treatment group” interaction as factors, and baseline as covariate|ezetimibe minus placebo||
1656063|NCT01611883|3047456|Superiority or Other||Difference in Least-squares Means|-21.05|||<|0.001|2-Sided|95.0|-25.06|-17.03|||Longitudinal analysis of covariance|Treatment group, HbA1c level, insulin use, time, and “time × treatment group” interaction as factors, and baseline as covariate|ezetimibe minus placebo||
1656064|NCT01611883|3047457|Superiority or Other|||||||0.365|||||||Fisher Exact|||Comparison of percentage difference between ezetimibe and placebo|
1656065|NCT01611883|3047458|Superiority or Other|||||||0.779|||||||Fisher Exact|||Comparison of percentage difference between ezetimibe and placebo|
1656066|NCT01611883|3047459|Superiority or Other||Difference in Least-squares Means|-4.8|||||2-Sided|95.0|-12.1|2.5|||||ezetimibe minus placebo||
1656067|NCT01611883|3047460|Superiority or Other||Difference in Least-squares Means|0.0|||||2-Sided|95.0|-0.47|0.47|||||ezetimibe minus placebo||
1656068|NCT01611883|3047461|Non-Inferiority or Equivalence|Ezetimibe treatment group will be considered non-inferior to the placebo control group if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference (ezetimibe minus placebo) in means for change in HbA1c from baseline to the end of treatment does not exceed 0.5%.|Difference in Least-squares Means|0.08|||||2-Sided|95.0|-0.07|0.23|||||ezetimibe minus placebo||
1656069|NCT01611792|3047466|Superiority||Mean Difference (Net)|0.69|Standard Deviation|2.12||0.19|2-Sided||||||Mixed Models Analysis||||
1656070|NCT01611792|3047467|Superiority||Mean Difference (Net)|0.69|Standard Deviation|2.12||0.19|2-Sided||||||Mixed Models Analysis||||
1656071|NCT01611792|3047468|Superiority||Mean Difference (Net)|-1.31|Standard Deviation|1.98||0.0018|2-Sided||||||Mixed Models Analysis||||
1656072|NCT01611792|3047469|Superiority||Mean Difference (Net)|2.0|Standard Deviation|5.36||0.36|2-Sided||||||Mixed Models Analysis||||
1656073|NCT01611792|3047470|Superiority||Mean Difference (Net)|-6.67|Standard Deviation|11.86||0.0038|2-Sided||||||Mixed Models Analysis||||
1656074|NCT01611792|3047471|Superiority||Mean Difference (Net)|-10.0|Standard Deviation|9.02|<|0.0001|2-Sided||||||Mixed Models Analysis||||
1656075|NCT01611155|3047508|Superiority|||||||0.89|||||||t-test, 2 sided|||autonomic subscale|
1656076|NCT01611155|3047508|Superiority|||||||0.53|||||||t-test, 2 sided|||Motor subscale|
1656077|NCT01611155|3047509|Superiority|||||||0.87|||||||t-test, 2 sided||||
1656078|NCT01611090|3047523|Superiority||Hazard Ratio (HR)|0.229|||<|0.0001|2-Sided|95.0|0.183|0.286|||Log Rank||||
1656079|NCT01610791|3047539|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Difference in LDL cholesterol from baseline to Week 24|
1656083|NCT01610700|3047574|Superiority or Other||Estimated mean treatment difference|-0.11||||0.904|2-Sided|95.0|-1.85|1.64|||ANCOVA|||The change from baseline in the mean Atkinson Morley Information Processing Battery test score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656084|NCT01610700|3047575|Superiority or Other||Estimated mean treatment difference|1.81||||0.048|2-Sided|95.0|0.02|3.6|||ANCOVA|||The change from baseline in the mean Guy's Neurological Disability Scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656085|NCT01610700|3047579|Superiority or Other||Estimated mean treatment difference|-0.47||||0.087|2-Sided|95.0|-1.01|0.07|||ANCOVA|||The change from baseline in the mean Barthel Activities for Daily Living scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656086|NCT01610700|3047580|Superiority or Other||Estimated mean treatment difference|-1.36||||0.717|2-Sided|95.0|-8.8|6.07|||ANCOVA|||The from baseline in the mean feeling upon wakening 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656087|NCT01610700|3047581|Superiority or Other||Estimated mean treatment difference|-4.53||||0.198|2-Sided|95.0|-11.45|2.4|||ANCOVA|||The change from baseline in the mean sleep amount 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656088|NCT01610700|3047582|Superiority or Other||Estimated mean treatment difference|-7.1||||0.047|2-Sided|95.0|-14.11|-0.08|||ANCOVA|||The from baseline in the mean sleep quality 100 mm visual analogue scale score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656089|NCT01610700|3047585|Superiority or Other||Estimated mean treatment difference|-0.12|Standard Error of the Mean|0.83||0.889|2-Sided|95.0|-1.77|1.54|||ANCOVA|||The change from baseline in the mean total bladder control test score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656090|NCT01610700|3047587|Superiority or Other||Estimated mean treatment difference|0.72||||0.647|2-Sided|95.0|-2.38|3.82|||ANCOVA|||The change from baseline in the mean total 28-item General Health Questionnaire score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656091|NCT01610700|3047589|Superiority or Other||Estimated mean treatment difference|-0.12||||0.427|2-Sided|95.0|-0.43|0.18|||ANCOVA|||The change baseline in the mean Fatigue Severity Scale Questionnaire score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656092|NCT01610700|3047590|Superiority or Other||Estimated mean treatment difference|0.69||||0.45|2-Sided|95.0|-1.11|2.5|||ANCOVA|||The change from baseline in the mean Beck's Depression Inventory score at the end of treatment was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656093|NCT01610700|3047592|Superiority or Other||Odds Ratio (OR)|1.36||||0.293|2-Sided|95.0|0.77|2.43|||Fisher Exact|||The proportion of subjects with better/much better assessments was compared between groups using a Fisher’s Exact Test.|
1656094|NCT01610700|3047593|Superiority or Other||Median Difference (Final Values)|-6.26|Standard Error of the Mean|4.36||0.154|2-Sided|95.0|-14.9|2.38|||ANCOVA|||The change in bladder problems visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656095|NCT01610700|3047594|Superiority or Other||Estimated mean treatment difference|-6.85||||0.311|2-Sided|95.0|-20.31|6.6|||ANCOVA|||The change in the tremor visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656096|NCT01610700|3047595|Superiority or Other||Estimated mean treatment difference|-3.3||||0.443|2-Sided|95.0|-11.82|5.21|||ANCOVA|||The change in the muscle spasm visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656097|NCT01610700|3047596|Superiority or Other||Estimated mean treatment difference|-1.88||||0.731|2-Sided|95.0|-12.73|8.96|||ANCOVA|||The change in the pain visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656098|NCT01610700|3047597|Superiority or Other||Estimated mean treatment difference|-7.1||||0.062|2-Sided|95.0|-14.56|0.37|||ANCOVA|||The change in the spasticity visual analogue scale score was compared between treatment groups using ANCOVA with baseline primary impairment score as the covariate.|
1656099|NCT01610700|3047598|Superiority or Other||Estimated mean treatment difference|-5.93||||0.124||95.0|-13.52|1.65|||ANCOVA|||The change in the primary impairment was compared between treatment groups using analysis of covariance (ANCOVA) with baseline primary impairment score as the covariate.|
1656100|NCT01610596|3047610|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1656101|NCT01610557|3047625|Superiority or Other||Mean Difference (Final Values)|-48.0|||<|0.001|2-Sided|95.0|-65.0|-31.0|||Linear mixed-effects model||The difference represents the estimated difference between ranibizumab and bevacizumab, adjusted for baseline visual acuity, study period, and clinical site and a subject effect for eyes nested within subject.||
1656102|NCT01610557|3047626|Superiority or Other||Mean Difference (Final Values)|1.3||||0.039|2-Sided|95.0|0.07|2.5|||Linear mixed-effects model||The difference represents the estimated difference between ranibizumab and bevacizumab, adjusted for baseline visual acuity, study period, and clinical site and a subject effect for eyes nested within subject.||
1656103|NCT01610492|3047666|Other||Geometric Mean|0.27|||||2-Sided|95.0|0.12|0.58|||||||
1656104|NCT01610492|3047667|Other||Geometric Mean|0.76|||||2-Sided|95.0|0.57|1.01|||||||
1656105|NCT01610453|3047668|Superiority or Other|||||||0.01|||||||Chi-squared||||
1656106|NCT01610453|3047669|Superiority or Other||||||<|0.01||||||A sample size calculation with alpha 0.05, power 0.8, and cut-off level of HPD at 40 mm. 146 women should be included. The calculation was based from a previous study, in which 93% with HPD ≤40 mm and 57% of with HPD > 40 mm delivered vaginally.|Chi-squared|||Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance ≤40 mm was used as cut-off level. Vaginal delivery was the primary outcome measure.|
1656107|NCT01610414|3047693|Superiority|Criterion: The lower limit (LL) of the 95% confidence interval (CI) for overall HZ vaccine efficacy was above 0%.|Vaccine efficacy|68.17|||<|0.0001|2-Sided|95.0|55.56|77.53|||Poisson method|||Vaccine efficacy (VE) was evaluated in the prevention of Herpes Zoster (HZ) in autologous haematopoietic stem cell transplant (HCT) recipients 18 years of agee and older.|
1656108|NCT01610271|3047702|Superiority|ABS was expected to be superior to Control.|Odds Ratio (OR)|0.11|Standard Error of the Mean|0.16||0.067|2-Sided|95.0|0.01|2.05||a priori threshold was 0.05|Regression, Logistic|penalized maximum likelihood (Firth) logistic regression, because infection rate was very low (<3%), as expected|The dispersion is the SE of the OR. ABS was the numerator group, Control was the denominator.|A sample size of 150 per group provided a power of 80% to detect a statistically significant (α≤0.05) 3% difference in SSI rate based on a historical infection rate of 6% in the facility where operations were performed.|
1656109|NCT01610063|3047726|Other|||||||0.002|||||||t-test, 2 sided|||Comparison for PHQ-9|
1656110|NCT01610063|3047727|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Comparison between groups for HAMD-17|
1656111|NCT01610063|3047728|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Comparison for QIDS-C16|
1656112|NCT01609790|3047753|Superiority or Other (legacy)|||||||0.7|||||||Chi-squared||||
1656113|NCT01609790|3047754|Superiority or Other (legacy)||Hazard Ratio (HR)|1.51||||0.04|2-Sided|95.0|1.02|2.24|||Log Rank||||
1656114|NCT01609790|3047755|Superiority or Other (legacy)||Hazard Ratio (HR)|1.46||||0.09|2-Sided|95.0|0.95|2.27|||Log Rank||||
1656115|NCT01609790|3047756|Superiority or Other (legacy)|||||||0.85|||||||Chi-squared||||
1656116|NCT01609790|3047757|Superiority or Other (legacy)|||||||0.98|||||||Z-test|One-sided test, significance level 0.15||Assuming a 36% 6-month (6m) rate in the placebo arm [from the March 2009 Food and Drug Administration (FDA) briefing], a 55% rate in the AMG 386 arm, and an exponential distribution corresponds to median PFS of 4.1 and 7 months, respectively, with a hazard ratio of 0.59 (AMG 386 arm vs. placebo arm). A total of 114 patients (57 per arm) will yield 85% power to detect an absolute 19% difference of 6m PFS rate at a 1-sided alpha level of 0.15 based on a 2-sample proportion test.|
1656117|NCT01609257|3047815|Superiority or Other|||||||0.562||||||Comparison of % Positive|Fisher Exact|||Any Day 1 to 30|
1656118|NCT01609257|3047816|Superiority or Other|||||||0.199|||||||Wilcoxon (Mann-Whitney)||||
1656119|NCT01609257|3047817|Superiority or Other|||||||0.037||||||Statistically significant at p<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||Score 2|
1656120|NCT01609257|3047817|Superiority or Other|||||||0.008||||||Statistically significant at p<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)|||Score 1|
1656121|NCT01609257|3047818|Superiority or Other|||||||0.001||||||Statistically significant at p<0.05. No multiplicity adjustment.|Wilcoxon (Mann-Whitney)||||
1656122|NCT01609257|3047825|Superiority or Other|||||||0.674||||||No multiplicity adjustment.|Fisher Exact||||
1656123|NCT01609010|3047848|Superiority or Other|||||||0.4963|||||||Log Rank|Stratified by previous treatment for lymphoma (yes or no).|||
1656124|NCT01609010|3047850|Superiority or Other|||||||0.8946|||||||Log Rank|Stratified by previous treatment for lymphoma (yes or no).|||
1656125|NCT01609010|3047852|Superiority or Other|||||||0.5942|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR only|
1656126|NCT01609010|3047852|Superiority or Other|||||||0.4419|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR+CRu|
1656127|NCT01609010|3047852|Superiority or Other|||||||0.784|||||||Log Rank|Stratification by previous treatment for lymphoma (yes or no).||CR+CRu+PR|
1656128|NCT01609010|3047854|Superiority or Other|||||||0.0051|||||||Chi-squared|||Week 16, Cycle 2|
1656129|NCT01609010|3047854|Superiority or Other|||||||0.854|||||||Chi-squared|||Week 10, Cycle 1|
1656130|NCT01609010|3047855|Superiority or Other|||||||0.1157|||||||Chi-squared|||Week 16, Cycle 2|
1656131|NCT01609010|3047855|Superiority or Other|||||||0.3362|||||||Chi-squared|||Week 10, Cycle 1|
1656132|NCT01609010|3047856|Superiority or Other|||||||0.3023|||||||Log Rank||||
1656133|NCT01608100|3047892|Superiority or Other||Positive Predictive Value|35.05|||||2-Sided|95.0|28.36|42.21||||||Time point: 4-9 hours|
1656134|NCT01608100|3047892|Superiority or Other||Positive Predictive Value|35.94|||||2-Sided|95.0|29.16|43.16||||||Time point: 2-4 hours|
1656135|NCT01608100|3047892|Superiority or Other||Positive Predictive Value|35.84|||||2-Sided|95.0|28.7|43.47||||||Time point: 0-2 hours|
1656136|NCT01608100|3047892|Superiority or Other||Positive Predictive Value|37.75|||||2-Sided|95.0|31.71|44.09||||||Time point: 4-9 hours|
1656137|NCT01608100|3047892|Superiority or Other||Positive Predictive Value|35.75|||||2-Sided|95.0|29.43|42.45||||||Time point: 2-4 hours|
1656138|NCT01608100|3047892|Superiority or Other||Positive Predictive Value|36.82|||||2-Sided|95.0|30.43|43.56||||||Time point: 0-2 hours|
1656139|NCT01608100|3047892|Superiority or Other||Positive Predictive Value|36.49|||||2-Sided|95.0|29.99|43.38||||||Time point: 4-9 hours|
1656140|NCT01608100|3047892|Superiority or Other||Positive Predictive Value|35.68|||||2-Sided|95.0|29.03|42.76||||||Time point: 2-4 hours|
1656141|NCT01608100|3047892|Superiority or Other||Positive Predictive Value|38.78|||||2-Sided|95.0|31.92|45.98||||||Time point: 0-2 hours|
1656142|NCT01608100|3047893|Superiority or Other||Negative Predictive Value|99.25|||||2-Sided|95.0|98.26|99.76||||||Time point: 4-9 hours|
1656143|NCT01608100|3047893|Superiority or Other||Negative Predictive Value|99.2|||||2-Sided|95.0|98.27|99.71||||||Time point: 2-4 hours|
1656144|NCT01608100|3047893|Superiority or Other||Negative Predictive Value|98.73|||||2-Sided|95.0|97.61|99.42||||||Time point: 0-2 hours|
1656145|NCT01608100|3047893|Superiority or Other||Negative Predictive Value|99.24|||||2-Sided|95.0|98.22|99.75||||||Time point: 4-9 hours|
1656146|NCT01608100|3047893|Superiority or Other||Negative Predictive Value|99.05|||||2-Sided|95.0|98.05|99.62||||||Time point: 2-4 hours|
1656147|NCT01608100|3047893|Superiority or Other||Negative Predictive Value|98.08|||||2-Sided|95.0|96.81|98.95||||||Time point: 0-2 hours|
1656148|NCT01608100|3047893|Superiority or Other||Negative Predictive Value|99.23|||||2-Sided|95.0|98.22|99.75||||||Time point: 4-9 hours|
1656153|NCT01608100|3047894|Superiority or Other||Percent Specificity|86.35|||||2-Sided|95.0|83.79|88.63||||||Time point: 0-2 hours|
1656154|NCT01608100|3047894|Superiority or Other||Percent Specificity|80.72|||||2-Sided|95.0|77.82|83.39||||||Time point: 4-9 hours|
1656155|NCT01608100|3047894|Superiority or Other||Percent Specificity|83.72|||||2-Sided|95.0|81.09|86.11||||||Time point: 2-4 hours|
1656156|NCT01608100|3047894|Superiority or Other||Percent Specificity|83.76|||||2-Sided|95.0|81.12|86.17||||||Time point: 0-2 hours|
1656157|NCT01608100|3047894|Superiority or Other||Percent Specificity|82.82|||||2-Sided|95.0|79.99|85.4||||||Time point: 4-9 hours|
1656158|NCT01608100|3047894|Superiority or Other||Percent Specificity|85.2|||||2-Sided|95.0|82.66|87.5||||||Time point: 2-4 hours|
1656159|NCT01608100|3047894|Superiority or Other||Percent Specificity|85.73|||||2-Sided|95.0|83.18|88.03||||||Time point: 0-2 hours|
1656160|NCT01608100|3047895|Superiority or Other||Percent Sensitivity|93.15|||||2-Sided|95.0|84.74|97.74||||||Time point: 4-9 hours|
1656161|NCT01608100|3047895|Superiority or Other||Percent Sensitivity|92.0|||||2-Sided|95.0|83.4|97.01||||||Time point: 2-4 hours|
1656162|NCT01608100|3047895|Superiority or Other||Percent Sensitivity|87.32|||||2-Sided|95.0|77.3|94.04||||||Time point: 0-2 hours|
1656163|NCT01608100|3047895|Superiority or Other||Percent Sensitivity|94.95|||||2-Sided|95.0|88.61|98.34||||||Time point: 4-9 hours|
1656164|NCT01608100|3047895|Superiority or Other||Percent Sensitivity|91.86|||||2-Sided|95.0|83.95|96.66||||||Time point: 2-4 hours|
1656165|NCT01608100|3047895|Superiority or Other||Percent Sensitivity|85.26|||||2-Sided|95.0|76.51|91.7||||||Time point: 0-2 hours|
1656166|NCT01608100|3047895|Superiority or Other||Percent Sensitivity|93.9|||||2-Sided|95.0|86.34|97.99||||||Time point: 4-9 hours|
1656167|NCT01608100|3047895|Superiority or Other||Percent Sensitivity|92.21|||||2-Sided|83.81|83.81|97.09||||||Time point: 2-4 hours|
1656168|NCT01608100|3047895|Superiority or Other||Percent Sensitivity|84.44|||||2-Sided|95.0|75.28|91.23||||||Time point: 0-2 hours|
1656169|NCT01608100|3047896|Superiority or Other||Hazard Ratio (HR)|3.55|||<|0.0001|2-Sided|95.0|2.08|6.03||Likelihood Ratio|Regression, Cox|||Hazard Ratio|
1656170|NCT01608100|3047896|Superiority or Other||Proportion Percentage|3.57|||<|0.0001|2-Sided||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier|
1656171|NCT01608100|3047896|Superiority or Other||Proportion Percentage|12.15|||<|0.0001|2-Sided||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier|
1656172|NCT01608100|3047896|Superiority or Other||Hazard Ratio (HR)|2.95|||<|0.005|2-Sided|95.0|1.41|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio|
1656173|NCT01608100|3047896|Superiority or Other||Proportion Percentage|2.09|||<|0.002|2-Sided||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier|
1656174|NCT01608100|3047896|Superiority or Other||Proportion Percentage|6.07|||<|0.002|2-Sided||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier|
1656175|NCT01608100|3047896|Superiority or Other||Hazard Ratio (HR)|3.68|||<|0.0001|2-Sided|95.0|2.25|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio|
1656176|NCT01608100|3047896|Superiority or Other||Proportion Percentage|3.66|||<|0.0001|2-Sided||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier|
1656177|NCT01608100|3047896|Superiority or Other||Proportion Percentage|12.83|||<|0.0001|2-Sided||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier|
1656178|NCT01608100|3047896|Superiority or Other||Hazard Ratio (HR)|3.54|||<|0.0002|2-Sided|95.0|1.84|6.87||Likelihood Ratio|Regression, Cox|||Hazard Ratio|
1656179|NCT01608100|3047896|Superiority or Other||Proportion Percentage|2.07|||<|0.0001|2-Sided||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier|
1656180|NCT01608100|3047896|Superiority or Other||Proportion Percentage|7.17|||<|0.0001|2-Sided||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier|
1656181|NCT01608100|3047896|Superiority or Other||Hazard Ratio (HR)|3.65|||<|0.0001|2-Sided|95.0|2.21|6.05||Likelihood Ratio|Regression, Cox|||Hazard Ratio|
1656182|NCT01608100|3047896|Superiority or Other||Proportion Percentage|3.65|||<|0.0001|2-Sided||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier|
1656183|NCT01608100|3047896|Superiority or Other||Proportion Percentage|12.76|||<|0.0001|2-Sided||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier|
1656184|NCT01608100|3047896|Superiority or Other||Hazard Ratio (HR)|3.09|||<|0.0011|2-Sided|95.0|1.59|5.95||Likelihood Ratio|Regression, Cox|||Hazard Ratio|
1656185|NCT01608100|3047896|Superiority or Other||Proportion Percentage|2.31|||<|0.0004|2-Sided||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value less than or equal to the cutoff|Kaplan-Meier|
1656186|NCT01608100|3047896|Superiority or Other||Proportion Percentage|7.0|||<|0.0004|2-Sided||||||Log Rank||Proportion percentage for subjects with ARCHITECT Troponin value greater than the cutoff|Kaplan-Meier|
1656187|NCT01608100|3047897|Superiority or Other||Area Under the Curve|0.9449|||||2-Sided|95.0|0.9046|0.9852||||||Time point: 4-9 hours|
1656188|NCT01608100|3047897|Superiority or Other||Area Under the Curve|0.9419|||||2-Sided|95.0|0.9041|0.9796||||||Time point: 2-4 hours|
1656189|NCT01608100|3047897|Superiority or Other||Area Under the Curve|0.9412|||||2-Sided|95.0|0.9102|0.9722||||||Time point: 0-2 hours|
1656190|NCT01608100|3047897|Superiority or Other||Area Under the Curve|0.9498|||||2-Sided|95.0|0.919|0.9805||||||Time point: 4-9 hours|
1656191|NCT01608100|3047897|Superiority or Other||Area Under the Curve|0.9349|||||2-Sided|95.0|0.8986|0.9712||||||Time point: 2-4 hours|
1656192|NCT01608100|3047897|Superiority or Other||Area Under the Curve|0.9197|||||2-Sided|95.0|0.8914|0.948||||||Time point: 0-2 hours|
1656193|NCT01608100|3047897|Superiority or Other||Area Under the Curve|0.9503|||||2-Sided|95.0|0.9419|0.9857||||||Time point: 4-9 hours|
1656194|NCT01608100|3047897|Superiority or Other||Area Under the Curve|0.9431|||||2-Sided|95.0|0.9081|0.9782||||||Time point: 2-4 hours|
1656195|NCT01608100|3047897|Superiority or Other||Area Under the Curve|0.9326|||||2-Sided|95.0|0.9048|0.9604||||||Time point: 0-2 hours|
1656196|NCT01608087|3047898|Equivalence|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.85|||||2-Sided|90.0|83.91|100.54|||||(R1/R2) * 100||Least square estimates of log-transformed PK endpoint for R1 and R2 were back transformed to original scale to get adjusted point estimator and interval estimates for the inter-subject ratio of the geometric means for treatments.
1656197|NCT01608087|3047898|Equivalence|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|93.25|||||2-Sided|90.0|87.12|99.81|||||(T/R2) * 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.
1656198|NCT01608087|3047898|Equivalence|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|101.53|||||2-Sided|90.0|92.74|111.14|||||(T/R1) * 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.
1656199|NCT01608087|3047899|Equivalence|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|92.63|||||2-Sided|90.0|85.18|100.74|||||(R1/R2) * 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.
1656200|NCT01608087|3047899|Equivalence|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.67|||||2-Sided|90.0|84.02|100.01|||||(T/R2) * 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.
1656201|NCT01608087|3047899|Equivalence|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|98.96|||||2-Sided|90.0|90.97|107.64|||||(T/R1) * 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.
1656202|NCT01608087|3047900|Equivalence|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|94.92|||||2-Sided|93.93|87.14|103.4|||||(R1/R2) * 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.
1656203|NCT01608087|3047900|Equivalence|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|91.68|||||2-Sided|93.93|83.5|100.65|||||(T/R2) * 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.
1656204|NCT01608087|3047900|Equivalence|Commonly applied acceptance range for bioequivalence/biosimilarity is 80% to 125%.|gMean ratio|96.58|||||2-Sided|93.93|88.54|105.35|||||(T/R1) * 100||Least squares estimates of log-transformed PK endpoint for T and R1 were back transformed to original scale to get adjusted point estimator and interval estimates for the ratio of the geometric means for treatments.
1656205|NCT01607957|3047902|Superiority||Hazard Ratio (HR)|0.48|||<|0.0001|2-Sided|95.0|0.41|0.57|||Stratified log-rank test||||
1656206|NCT01607957|3047903|Superiority||Hazard Ratio (HR)|0.68|||<|0.0001|2-Sided|95.0|0.58|0.81|||Stratified log-rank test||||
1656207|NCT01607476|3047957|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1656208|NCT01607476|3047957|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1656209|NCT01607476|3047957|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1656210|NCT01607476|3047958|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1656211|NCT01607476|3047958|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1656212|NCT01607476|3047958|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1656213|NCT01607411|3047964|Superiority or Other||Adjusted Mean Difference|0.3||||0.004|2-Sided|95.0|0.1|0.5||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656214|NCT01607411|3047964|Superiority or Other||Adjusted Mean Difference|0.29||||0.0047|2-Sided|95.0|0.09|0.49||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656215|NCT01607411|3047964|Superiority or Other||Adjusted Mean Difference|-0.005||||0.9631|2-Sided|95.0|-0.21|0.2||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656216|NCT01607411|3047964|Superiority or Other||Adjusted Mean Difference|0.49|||<|0.0001|2-Sided|95.0|0.29|0.69||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656217|NCT01607411|3047964|Superiority or Other||Adjusted Mean Difference|0.79|||<|0.0001|2-Sided|95.0|0.58|0.99||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656218|NCT01607411|3047964|Superiority or Other||Adjusted Mean Difference|0.78|||<|0.0001|2-Sided|95.0|0.58|0.98||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random factor|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656219|NCT01607411|3047965|Superiority or Other||Adjusted Mean Difference|6.31||||0.0073|2-Sided|95.0|1.72|10.89||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656220|NCT01607411|3047965|Superiority or Other||Adjusted Mean Difference|6.1||||0.0094|2-Sided|95.0|1.52|10.69||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656221|NCT01607411|3047965|Superiority or Other||Adjusted Mean Difference|-0.21||||0.9292|2-Sided|95.0|-4.79|4.38||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656222|NCT01607411|3047965|Superiority or Other||Adjusted Mean Difference|28.55|||<|0.0001|2-Sided|95.0|23.97|33.13||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656223|NCT01607411|3047965|Superiority or Other||Adjusted Mean difference|34.86|||<|0.0001|2-Sided|95.0|30.28|39.44||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656224|NCT01607411|3047965|Superiority or Other||Adjusted Mean Difference|34.65|||<|0.0001|2-Sided|95.0|30.07|39.24||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656225|NCT01607411|3047966|Superiority or Other||Adjusted Mean Difference|1.2||||0.2352|2-Sided|95.0|-0.79|3.19||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656226|NCT01607411|3047966|Superiority or Other||Adjusted Mean Difference|2.44||||0.0168|2-Sided|95.0|0.44|4.43||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.|
1656227|NCT01607411|3047966|Superiority or Other||Adjusted Mean Difference|1.23||||0.2225|2-Sided|95.0|-0.76|3.22||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656228|NCT01607411|3047967|Superiority or Other||Adjusted Mean Difference|3.16||||0.0021|2-Sided|95.0|1.17|5.15||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656229|NCT01607411|3047967|Superiority or Other||Adjusted Mean Difference|4.36|||<|0.0001|2-Sided|95.0|2.37|6.35||No adjustment was required for multiple comparisons as the primary comparison was pre-specified|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels|
1656230|NCT01607411|3047967|Superiority or Other||Adjusted Mean Difference|5.59|||<|0.0001|2-Sided|95.0|3.6|7.58||No adjustment was required for multiple comparisons as the primary comparison was pre-specified.|ANOVA|The fixed factors for ANOVA were study period and treatment and the subject was random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.|
1656321|NCT01604941|3048274|Superiority or Other|||||||0.0123||||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing|
1656231|NCT01607398|3047987|Superiority or Other||Median Difference (Final Values)|-8.05||||0.5146|2-Sided|95.0|-20.5|7.6|||Wilcoxon (Mann-Whitney)|The analysis was done using the Van Elteren extension to the Wilcoxon rank sum test.|From Van-Elteren extension to the Wilcoxon Rank Sum test, adjusted for smoking status strata and Hodges-Lehmann estimator of the 95% CI, not stratified and unadjusted for multiplicity.||
1656232|NCT01607203|3048004|Non-Inferiority or Equivalence|t -test||||||0.04|||||||Fisher Exact||||
1656233|NCT01606761|3048027|Superiority or Other||Percentage Difference|13.4|||<|0.001|2-Sided|95.0|7.8|19.1|||Cochran-Mantel-Haenszel||||
1656234|NCT01606761|3048027|Superiority or Other||Percentage Difference|11.0|||<|0.001|2-Sided|95.0|5.5|16.5|||Cochran-Mantel-Haenszel||||
1656235|NCT01606761|3048028|Superiority or Other||Percentage Difference|12.7|||<|0.001|2-Sided|95.0|7.0|18.4|||Cochran-Mantel-Haenszel||||
1656236|NCT01606761|3048028|Superiority or Other||Percentage Difference|12.0|||<|0.001|2-Sided|95.0|6.4|17.7|||Cochran-Mantel-Haenszel||||
1656237|NCT01606761|3048029|Superiority or Other||LS Mean Difference|-0.194|||<|0.001|2-Sided|95.0|-0.275|-0.112|||ANCOVA||||
1656238|NCT01606761|3048029|Superiority or Other||Least Square (LS) mean difference|-0.17|||<|0.001|2-Sided|95.0|-0.251|-0.088|||ANCOVA||||
1656239|NCT01606761|3048030|Superiority or Other||Percentage Difference|21.0|||<|0.001|2-Sided|95.0|13.6|28.5|||Cochran-Mantel-Haenszel||||
1656240|NCT01606761|3048030|Superiority or Other||Percentage Difference|15.9|||<|0.001|2-Sided|95.0|8.5|23.2|||Cochran-Mantel-Haenszel||||
1656241|NCT01606319|3048051|Superiority or Other||relative rate|0.99||||0.94|2-Sided|95.0|0.72|1.37|||log-linear model|log-linear model in which the number of exacerbations was assumed to follow a negative binomial distribution|relative rate with acetaminophen in the numerator and ibuprofen in the denominator||
1656242|NCT01606319|3048052|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.69|2-Sided|95.0|-0.9|0.6|||ANCOVA||||
1656243|NCT01606319|3048053|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.5|2-Sided|95.0|-0.039|0.0019|||ANCOVA||||
1656244|NCT01606319|3048054|Superiority or Other||relative rate|0.94||||0.67|2-Sided|95.0|0.69|1.28|||log-linear model|log-linear model in which the number of exacerbations was assumed to follow a negative binomial distribution|relative rate with acetaminophen in the numerator and ibuprofen in the denominator||
1656245|NCT01606306|3048055|Superiority or Other||||||<|0.0001||||||Rank-ordered logistic regression (ROLR) was used to model the probability of best response for each treatment and bootstrapping was used to calculate confidence intervals.|rank-order logistic regression|ROLR is in the class of Discrete Choice models, which seek to estimate the probability that an individual responds best to a specific treatments.||The primary analysis tested the null hypothesis of all three treatments having equal probability to yield the best response as defined by the criteria defining the primary outcome. A sample size of 300 participants was selected to test the primary null hypothesis of all three treatments having equal probability (one-third) to yield the best response with statistical power of at least 0.90 if any one of the three treatments actually has probability of at least one-half to yield the best response.|The probabilistic construct of the Discrete Choice (DC) model does not reflect individual behavior that is intrinsically probabilistic, but rather population heterogeneity. DC models rely on stochastic assumptions to account for unobserved factors related to the treatments themselves and to characteristics of study participants. Specifically, that each treatment has an underlying utility that may differ from one individual to another. Mathematically, these utilities are represented by U_t, where t denotes the treatment. Utility can be thought of as a latent variable quantifying treatment response where higher values indicate better response. The U_t can be used to find the probability (P) of best response for each treatment by the following equation: P_t = exp(U_t) / [exp(U_A) + exp(U_B) + exp(U_C)], where A, B, and C, denote the three study treatments. The primary analysis tested whether the three treatments have equal utility and, thus, equal probability of best response.
1656246|NCT01606202|3048089|Superiority or Other||Estimated mean treatment difference|-1.93||||0.032|2-Sided|95.0|-3.69|-0.16|||ANCOVA|||The change from baseline to End of Treatment in the Brief Pain Inventory score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Brief Pain Inventory score as a covariate.|
1656247|NCT01606202|3048090|Superiority or Other||Estimated mean treatment difference|33.86|||<|0.001|2-Sided|95.0|17.07|50.64|||Fisher Exact|||The proportion of subjects who considered their condition ‘Very Much Improved’, ‘Much Improved’ or ‘Minimally Improved’ was compared between treatment groups using Fisher’s Exact Test.|
1656248|NCT01606202|3048091|Superiority or Other||Estimated mean treatment difference|-1.29||||0.287|2-Sided|95.0|-3.74|1.16|||ANCOVA|||The change from baseline to End of Treatment in the Caregiver Strain Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline Caregiver Strain Index score as a covariate.|
1656249|NCT01606202|3048092|Superiority or Other||Estimated mean treatment difference|-0.04||||0.847|2-Sided|95.0|-0.49|0.4|||ANCOVA|||The change from baseline to End of Treatment in the Spitzer Quality of Life Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spitzer Quality of Life Index score as a covariate.|
1656250|NCT01606202|3048093|Superiority or Other||Estimated mean treatment difference|-0.11||||0.824|2-Sided|95.0|-1.13|0.9|||ANCOVA|||The change from baseline in the mean Short Orientation Memory Concentration score, was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Short Orientation Memory Concentration test score as a covariate.|
1656251|NCT01606202|3048094|Superiority or Other||Estimated mean treatment difference|-0.14||||0.142|2-Sided|95.0|-0.33|0.05|||ANCOVA|||The change from baseline to End of Treatment in the Modified Ashworth scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Modified Ashworth scale score as a covariate.|
1656252|NCT01606202|3048095|Superiority or Other||Estimated mean treatment difference|0.4||||0.86|2-Sided|95.0|-4.08|4.88|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which spasticity was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the percentage of days on which spasticity was experienced as a covariate.|
1656444|NCT01603056|3048512|Superiority or Other|||||||0.222|||||||t-test, 2 sided||||
1656253|NCT01606202|3048096|Superiority or Other||Estimated mean treatment difference|0.07||||0.83|2-Sided|95.0|-0.61|0.75|||ANCOVA|||The change from baseline to End of Treatment in the spasticity severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline spasticity severity Numerical Rating Scale score as a covariate.|
1656254|NCT01606202|3048097|Superiority or Other||Estimated mean treatment difference|-0.64||||0.873|2-Sided|95.0|-8.56|7.27|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which spasm was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm percentage of days on which spasm was experienced as a covariate.|
1656255|NCT01606202|3048098|Superiority or Other||Estimated mean treatment difference|0.05||||0.86|2-Sided|95.0|-0.54|0.65|||ANCOVA|||The change from baseline to End of Treatment in the Spasm severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm severity Numerical Rating Scale score as a covariate.|
1656256|NCT01606202|3048099|Superiority or Other||Estimated mean treatment difference|-0.57||||0.852|2-Sided|95.0|-6.62|5.48|||ANCOVA|||The change from baseline to End of Treatment in the percentage of days on which escape medication was used was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and percentage of days on which escape medication was used as a covariate.|
1656257|NCT01606202|3048100|Superiority or Other||Estimated mean treatment difference|-0.08||||0.708|2-Sided|95.0|-0.51|0.35|||ANCOVA|||The change in the pain Numerical Rating Scale score from baseline to End of Treatment was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale pain mean score as a covariate.|
1656258|NCT01606189|3048102|Superiority or Other||Estimated mean treatment difference|-1.21||||0.178|2-Sided|95.0|-2.97|0.56|||ANOVA|||12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period|
1656259|NCT01606189|3048102|Superiority or Other||Estimated mean treatment difference|-2.23||||0.015|2-Sided|95.0|-4.01|-0.45|||ANOVA|||12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period|
1656260|NCT01606189|3048103|Superiority or Other||Estimated mean treatment difference|0.43||||0.739|2-Sided|95.0|-2.12|2.98|||ANOVA|||Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period|
1656261|NCT01606189|3048103|Superiority or Other||Estimated mean treatment difference|-1.75||||0.181|2-Sided|95.0|-4.32|0.83|||ANOVA|||Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period|
1656262|NCT01606189|3048104|Superiority or Other||Mann-Whitney U statistic|1200.5||||0.56||95.0|||||Wilcoxon (Mann-Whitney)|||Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.|
1656263|NCT01606189|3048104|Superiority or Other||Mann-Whitney U statistic|1222.0||||0.328||95.0|||||Wilcoxon (Mann-Whitney)|||Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.|
1656264|NCT01606189|3048105|Superiority or Other||Estimated mean treatment difference|-8.99||||0.037|2-Sided|95.0|-17.41|-0.57|||ANOVA|||Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period|
1656265|NCT01606189|3048105|Superiority or Other||Estimated mean treatment difference|-7.28||||0.092|2-Sided|95.0|-15.78|1.21|||ANOVA|||Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period|
1656266|NCT01606189|3048106|Superiority or Other||Estimated mean treatment difference|-2.2||||0.04|2-Sided|95.0|-4.29|-0.1|||ANOVA|||Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period|
1656267|NCT01606189|3048106|Superiority or Other||Estimated mean treatment difference|-1.55||||0.146|2-Sided|95.0|-3.64|0.55|||ANOVA|||Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period|
1656268|NCT01606189|3048107|Superiority or Other||Estimated mean treatment difference|0.79||||0.001|2-Sided|95.0|0.33|1.24|||ANOVA|||Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period|
1656269|NCT01606189|3048107|Superiority or Other||Estimated mean treatment difference|0.55||||0.019|2-Sided|95.0|0.09|1.01|||ANOVA|||Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period|
1656270|NCT01606189|3048108|Superiority or Other||Estimated mean treatment difference|-0.33|||<|0.001|2-Sided|95.0|-0.49|-0.16|||ANOVA|||Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period|
1656271|NCT01606189|3048108|Superiority or Other||Estimated mean treatment difference|-0.2|||<|0.017|2-Sided|95.0|-0.37|-0.04|||ANOVA|||Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period|
1656272|NCT01606189|3048109|Superiority or Other||Estimated mean treatment difference|-0.64||||0.002|2-Sided|95.0|-1.03|-0.24|||ANOVA|||Box Scale-11 pain scores were compared between treatment groups using an ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period|
1656273|NCT01606189|3048109|Superiority or Other||Estimated mean treatment difference|-0.58||||0.005|2-Sided|95.0|-0.98|-0.18|||ANOVA|||Box Scale-11 pain scores were compared between treatment groups using an analysis of variance (ANOVA). The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period|
1656274|NCT01606176|3048111|Superiority or Other||Estimated mean treatment difference|3.95||||1|2-Sided|95.0|-21.85|27.47|||Fisher Exact|||The proportion of patients who considered their condition “Very Much Improved” or “Much Improved” was compared between treatment groups using a Fisher’s Exact Test.|
1656275|NCT01606176|3048112|Superiority or Other||Estimated mean treatment difference|0.04||||0.915|2-Sided|95.0|-0.79|0.88|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment"|
1656276|NCT01606176|3048113|Superiority or Other||Estimated mean treatment difference|-3.77||||0.031|2-Sided|95.0|-7.17|-0.36|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment"|
1656277|NCT01606176|3048114|Superiority or Other||Estimated mean treatment difference|-5.18||||0.134|2-Sided|95.0|-12.05|1.68|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment"|
1656278|NCT01606176|3048115|Superiority or Other||Estimated mean treatment difference|-0.32||||0.184|2-Sided|95.0|-0.8|0.16|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment"|
1656279|NCT01606176|3048116|Superiority or Other||Estimated mean treatment difference|-31.77||||0.009|2-Sided|95.0|-55.07|-8.47|||ANOVA|||The proportions were compared between treatment groups using ANOVA with treatment as a factor.|
1656280|NCT01606176|3048117|Superiority or Other||Estimated mean treatment difference|-0.86||||0.128|2-Sided|95.0|-1.97|0.26|||ANCOVA|||"The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment"|
1656281|NCT01606176|3048118|Superiority or Other||Estimated mean treatment difference|-1.47||||1|2-Sided|95.0|-21.56|18.51|||Fisher Exact|||The proportion of patients who considered their condition “Very Much Improved” or “Much Improved” was compared between treatment groups using a Fisher’s Exact Test.|
1656282|NCT01606176|3048119|Superiority or Other||Estimated mean treatment difference|0.28||||0.387|2-Sided|95.0|-0.36|0.91|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Spitzer Quality of Life Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Spitzer Quality of Life Index Score = Baseline Total Spitzer Quality of Life Index Score + Treatment"|
1656283|NCT01606176|3048120|Superiority or Other||Estimated mean treatment difference|-1.66||||0.233|2-Sided|95.0|-4.42|1.1|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Total Brief Pain Inventory (Short Form) score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Total Brief Pain Inventory (Short Form) Score = Baseline Total Brief Pain Inventory (Short Form) Score + Treatment"|
1656284|NCT01606176|3048121|Superiority or Other||Mean Difference (Final Values)|-2.79||||0.3|2-Sided|95.0|-8.14|2.56|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline Pain Disability Index score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Pain Disability Index Score = Baseline Pain Disability Index Score + Treatment"|
1656285|NCT01606176|3048122|Superiority or Other||Estimated mean treatment difference|-0.34||||0.052|2-Sided|95.0|-0.68|0.0|||ANCOVA|||"The change was compared between treatment groups using ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep disturbance score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Sleep Disturbance Score = Baseline Sleep Disturbance Score + Treatment"|
1656286|NCT01606176|3048123|Superiority or Other||Estimated mean treatment difference|-29.55||||0.002|2-Sided|95.0|-48.08|-11.02|||ANOVA|||The proportions were compared between treatment groups using analysis of variance (ANOVA) with treatment as a factor.|
1656445|NCT01603056|3048513|Superiority or Other|||||||0.497|||||||t-test, 2 sided||||
1656287|NCT01606176|3048124|Superiority or Other||Estimated mean treatment difference|-0.39||||0.332|2-Sided|95.0|-1.18|0.4|||ANCOVA|||"The change was compared between treatment groups using analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in Box Scale-11 Pain Score = Baseline Pain Score + Treatment"|
1656288|NCT01606124|3048144|Superiority|||||||0.1439|||||||Wilcoxon (Mann-Whitney)||||
1656289|NCT01606124|3048145|Superiority|||||||0.5631|||||||Wilcoxon (Mann-Whitney)||||
1656290|NCT01606007|3048146|Superiority or Other||Mean Difference (Final Values)|-2.05|Standard Error of the Mean|0.3451|||2-Sided|95.0|-2.73|-1.37|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value>0.05.||
1656291|NCT01606007|3048147|Superiority or Other||Mean difference in percentages|19.1|Standard Error of the Mean|4.587|||2-Sided|95.0|10.1|28.1|||||Modified Logistic Regression was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value>0.05.||
1656292|NCT01606007|3048147|Superiority or Other||Mean difference in percentages|23.1|Standard Error of the Mean|4.282|||2-Sided|95.0|14.7|31.5|||||Modified Logistic Regression was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value>0.05.||
1656293|NCT01606007|3048148|Superiority or Other||Mean Difference (Final Values)|-6.1|Standard Error of the Mean|3.957|||2-Sided|95.0|-13.8|1.7|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value>0.05.||
1656294|NCT01606007|3048148|Superiority or Other||Mean Difference (Final Values)|-23.8|Standard Error of the Mean|3.988|||2-Sided|95.0|-31.6|-15.9|||||ANCOVA was applied for comparison, but p-value was not reported because at least one prior test in the hierarchical testing procedure yielded p-value>0.05.||
1656295|NCT01606007|3048149|Superiority or Other||Mean Difference (Final Values)|-9.1|Standard Error of the Mean|4.923||0.0639|2-Sided|95.0|-18.8|0.5||Each secondary endpoint was tested at alpha=0.05; significance testing stops at the endpoint where p-value>0.05.|ANCOVA|||LOCF|
1656296|NCT01606007|3048149|Superiority or Other||Mean Difference (Final Values)|-44.0|Standard Error of the Mean|4.914|<|0.0001|2-Sided|95.0|-53.7|-34.3||Each secondary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|ANCOVA|||LOCF|
1656297|NCT01606007|3048150|Superiority or Other||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.1108||0.0166|2-Sided|95.0|-0.48|-0.05||Primary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|Mixed Models Analysis||||
1656298|NCT01606007|3048150|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|0.1112|<|0.0001|2-Sided|95.0|-0.81|-0.37||Primary endpoint was tested at alpha=0.05; significance was claimed only if Saxagliptin+Dapagliflozin+Metformin was superior to both Saxagliptin+Metformin and Dapagliflozin+Metformin.|Mixed Models Analysis||||
1656299|NCT01605669|3048208|Superiority or Other||Percent Error Rate|25.0||||||95.0|||||||Error rate of 9/36 is equal to total of false positives plus false negatives over the total of participants analyzed.||
1656300|NCT01605669|3048208|Superiority or Other||Percent Specificity|72.4||||||95.0|||||||||
1656301|NCT01605669|3048208|Superiority or Other||Percentage Sensitivity|85.7||||||95.0|||||||||
1656302|NCT01605552|3048215|Superiority or Other|||||||0.43|||||||ANCOVA||||
1656303|NCT01605552|3048216|Superiority or Other|||||||0.38|||||||ANCOVA||||
1656304|NCT01605552|3048217|Superiority or Other|||||||0.019|||||||ANCOVA||||
1656305|NCT01605552|3048218|Superiority or Other|||||||0.21|||||||ANCOVA||||
1656306|NCT01605396|3048242|Other||Hazard Ratio (HR)|1.38||||0.562|2-Sided|95.0|0.46|4.13|||Regression, Cox|||HR and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).|
1656307|NCT01605396|3048243|Other||Difference of Percentages|-10.0||||0.267|2-Sided|95.0|-27.8|8.0|||Miettinen and Nurminen’s Method|||Miettinen and Nurminen’s method was used to compare ORR between the two treatment arms (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm), and to calculate a p-value and 95% confidence interval (CI) for the difference in response rates.|
1656308|NCT01605396|3048245|Superiority||Hazard Ratio (HR)|1.18||||0.565|2-Sided|80.0|0.81|1.72|||Regression, Cox|||Hazard ratio (HR) and p-value for treatment difference based on Cox regression model with Efron tie handling for treatment comparison (Ridaforolimus + Dalotuzumab + Exemestane arm versus Ridaforolimus + Exemestane arm).|
1656309|NCT01605292|3048248|Superiority or Other|||||||0.007|||||||Fisher Exact||||
1656310|NCT01605292|3048250|Superiority or Other|||||||0.75|||||||Fisher Exact||||
1656311|NCT01605292|3048251|Superiority or Other|||||||0.07|||||||Chi-squared||||
1656312|NCT01605292|3048252|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1656313|NCT01605292|3048253|Superiority or Other|||||||0.56|||||||Fisher Exact||||
1656314|NCT01605292|3048254|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1656315|NCT01605292|3048255|Superiority or Other|||||||0.006|||||||t-test, 2 sided||||
1656316|NCT01605292|3048256|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1656317|NCT01605227|3048257|Superiority or Other||Hazard Ratio (HR)|0.48|||<|0.001|2-Sided|95.0|0.4|0.57|||Log Rank|The Log-Rank Test was stratified by prior cabazitaxel, baseline pain severity, and baseline Eastern Cooperative Oncology Group Performance Status.|||
1656318|NCT01605227|3048258|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) Test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.|||
1656319|NCT01605227|3048259|Superiority or Other||Cox Proportional Hazard|0.9||||0.213|2-Sided|95.0|0.76|1.06|||Log Rank|The Log-Rank test was stratified by prior cabazitaxel, baseline pain severity and baseline ECOG performance status.|||
1656320|NCT01604941|3048274|Superiority or Other|||||||0.2334||||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing|
1656322|NCT01604941|3048274|Superiority or Other|||||||0.1683||||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing|
1656323|NCT01604941|3048275|Superiority or Other|||||||0.7679||||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 16 for all participants with BID dosing|
1656324|NCT01604941|3048275|Superiority or Other|||||||0.2618||||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 8 for all participants with BID dosing|
1656325|NCT01604941|3048275|Superiority or Other|||||||0.6703||||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 8 for 50 mg/kg/d dosing|
1656326|NCT01604941|3048276|Superiority or Other|||||||0.3291||||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing|
1656327|NCT01604941|3048276|Superiority or Other|||||||0.4549||||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing|
1656328|NCT01604941|3048276|Superiority or Other|||||||0.3202||||||The P-value is from Paired t-test for log-transformed data at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing|
1656329|NCT01604941|3048277|Superiority or Other|||||||0.0332||||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing|
1656330|NCT01604941|3048277|Superiority or Other|||||||0.0004||||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing|
1656331|NCT01604941|3048277|Superiority or Other|||||||0.0394||||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing|
1656332|NCT01604941|3048278|Superiority or Other|||||||0.1695||||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing|
1656333|NCT01604941|3048278|Superiority or Other|||||||0.0019||||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing|
1656334|NCT01604941|3048278|Superiority or Other|||||||0.0365||||||P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing|
1656335|NCT01604941|3048279|Superiority or Other|||||||0.6303||||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 24 for all participants with BID dosing|
1656336|NCT01604941|3048279|Superiority or Other|||||||0.04||||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for all participants with BID dosing|
1656337|NCT01604941|3048279|Superiority or Other|||||||0.296||||||The P-value is from analysis of paired t-test at post treatment timepoint vs. Baseline.|paired t-test|||Analysis of Week 12 for 50 mg/kg/d dosing|
1656338|NCT01604850|3048285|Superiority or Other||Proportion difference|-22.4|||<|0.001|2-Sided|95.0|-34.4|-10.3||P-value is from the Cochran-Mantel-Haenszel (CMH) test stratified by the randomization stratification factor (ie, presence/absence of cirrhosis, genotype 2 or 3).|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% confidence interval (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|A sample size of 100 subjects in each group would provide over 97% power to detect at least 20% improvement in SVR12 rate from the assumed null rate of 25% using 2-sided exact 1-sample binomial test at significance level of 0.025.|
1656339|NCT01604408|3048293|Superiority or Other||LS Mean Difference|0.017||||0.478|2-Sided|90.0|-0.023|0.057|||Mixed Model Repeated Measures||||
1656340|NCT01604408|3048294|Superiority or Other||LS Mean Difference|-1.062||||0.191|2-Sided|90.0|-2.4|0.276|||Mixed Model Repeated Measures||||
1656341|NCT01604408|3048295|Superiority or Other||LS Mean Difference|-0.461||||0.073|2-Sided|90.0|-0.883|-0.039|||Mixed Model Repeated Measures||||
1656342|NCT01604408|3048296|Superiority or Other||LS Mean Difference|0.426|||<|0.001|2-Sided|95.0|0.192|0.66|||Mixed Model Repeated Measures||||
1656343|NCT01604343|3048325|Superiority or Other||Percentage Difference|7.2|||<|0.001|2-Sided|95.0|4.6|9.8|||Cochran-Mantel-Haenszel||||
1656344|NCT01604343|3048325|Superiority or Other||Percentage Difference|3.6|||<|0.001|2-Sided|95.0|1.4|5.8|||Cochran-Mantel-Haenszel||||
1656345|NCT01604343|3048326|Superiority or Other||Percentage Difference|19.9|||<|0.001|2-Sided|95.0|15.8|24.0|||Cochran-Mantel-Haenszel||||
1656346|NCT01604343|3048326|Superiority or Other||Percentage Difference|20.5|||<|0.001|2-Sided|95.0|16.4|24.6|||Cochran-Mantel-Haenszel||||
1656347|NCT01604343|3048327|Superiority or Other||Percentage Difference|20.8|||<|0.001|2-Sided|95.0|16.1|25.6|||Cochran-Mantel-Haenszel||||
1656348|NCT01604343|3048327|Superiority or Other||Percentage Difference|17.8|||<|0.001|2-Sided|95.0|13.1|22.4|||Cochran-Mantel-Haenszel||||
1656349|NCT01604343|3048328|Superiority or Other||LS mean difference|-0.256|||<|0.001|2-Sided|95.0|-0.32|-0.2|||ANCOVA||||
1656350|NCT01604343|3048328|Superiority or Other||Least Square (LS) mean difference|-0.226|||<|0.001|2-Sided|95.0|-0.29|-0.17|||ANCOVA||||
1656351|NCT01604343|3048329|Superiority or Other||||||<|0.001|||||||van der waerden ANOVA||||
1656352|NCT01604343|3048329|Superiority or Other||||||<|0.001|||||||van der waerden ANOVA||||
1656353|NCT01604343|3048330|Superiority or Other||Percentage Difference|27.1|||<|0.001|2-Sided|95.0|21.6|32.6|||Cochran-Mantel-Haenszel||||
1656354|NCT01604343|3048330|Superiority or Other||Percentage Difference|28.4|||<|0.001|2-Sided|95.0|22.8|33.8|||Cochran-Mantel-Haenszel||||
1656355|NCT01604291|3048331|Other||phi-coefficient|-0.1672||||0.0033|||||||Fisher Exact|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables.|Correlation with dose modification for Telaprevir/boceprevir.|
1656356|NCT01604291|3048331|Other||phi-coefficient|0.0666||||0.2052|||||||Chi-squared|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables.|Correlation with dose modification for Ribavirin.|
1656357|NCT01604291|3048331|Other||phi-coefficient|-0.0835||||0.0463|||||||Chi-squared|The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|phi-coefficient is a measure of the degree of association between two binary variables|Correlation with dose modification for Peginterferon alfa-2a.|
1656358|NCT01604291|3048344|Other|||||||0.4618||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Body mass index.|
1656359|NCT01604291|3048344|Other|||||||0.3376||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Weight|
1656360|NCT01604291|3048344|Other|||||||0.9269||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Height|
1656361|NCT01604291|3048344|Other|||||||0.1163||||||A t-test was done to compare SVR participants to non-SVR.|t-test, 1 sided|||Correlation between SVR 24 and Age|
1656362|NCT01604291|3048344|Other|||||||0.9109||||||The p-value from chi-square is the difference between SVR achieved (yes/no) and dose modifications.|Chi-squared|||Correlation between SVR 24 and Gender|
1656363|NCT01604265|3048358|Superiority or Other||Estimated mean treatment difference|0.06||||0.535|2-Sided|95.0|-0.13|0.24|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.|
1656364|NCT01604265|3048359|Superiority or Other||Estimated mean treatment difference|-0.64||||0.249|2-Sided|95.0|-1.75|0.46|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.|
1656365|NCT01604265|3048360|Superiority or Other||Estimated mean treatment difference|0.09||||0.88|2-Sided|95.0|-1.06|1.23|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.|
1656366|NCT01604265|3048362|Superiority or Other||Estimated mean treatment difference|-1.5||||0.164|2-Sided|95.0|-3.64|0.63|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.|
1656367|NCT01604265|3048363|Superiority or Other||Estimated mean treatment difference|2.68||||0.257|2-Sided|95.0|-2.01|7.37|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.|
1656368|NCT01604265|3048364|Superiority or Other||Median Difference (Final Values)|0.29|Standard Error of the Mean|2.44||0.905|2-Sided|95.0|-4.6|5.18|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.|
1656369|NCT01604265|3048365|Superiority or Other||Estimated mean treatment difference|-2.53||||0.064|2-Sided|95.0|-5.22|0.15|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.|
1656370|NCT01604265|3048366|Superiority or Other||Estimated mean treatment difference|2.54||||0.23|2-Sided|95.0|-1.64|6.71|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.|
1656371|NCT01604265|3048367|Superiority or Other||Estimated mean treatment difference|-6.95||||0.009|2-Sided|95.0|-12.12|-1.77|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.|
1656372|NCT01604265|3048368|Superiority or Other||estimated mean treatment difference|-6.82||||0.039|2-Sided|95.0|-13.28|-0.37|||ANCOVA|||The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline score, was assessed using the F-test from the ANCOVA.|
1656373|NCT01604265|3048369|Superiority or Other||Odds Ratio (OR)|3.896||||0.005|2-Sided|95.0|1.51|10.055|||Regression, Logistic|||The proportion of patients who considered their condition “Very Much Improved” or “Much Improved” was compared between treatment groups using a Fisher’s Exact Test. Results were presented in terms of difference in percentages, and 95% CI based on the normal approximation to the binomial, and p-value.|
1656374|NCT01604265|3048370|Superiority or Other||Estimated mean treatment difference|-1.39||||0.003|2-Sided|95.0|-2.27|-0.5|||ANCOVA|||"The change was compared between treatment groups using a one way ANCOVA. The significance of the treatment effect, after adjusting for baseline sleep score, was assessed using the F-test from the ANCOVA. The model was as follows:~Change in 0-10 Numerical Rating Scale sleep Score = Baseline Sleep Score + Treatment"|
1656375|NCT01604265|3048371|Superiority or Other||Estimated mean treatment difference|-1.25||||0.005|2-Sided|95.0|-2.11|-0.39|||ANCOVA|||The change was compared between treatment groups using a one way analysis of covariance (ANCOVA). The significance of the treatment effect, after adjusting for baseline pain score, was assessed using the F-test from the ANCOVA. The model was as follows: Change in 0-10 Numerical Rating Scale Pain Score = Baseline Pain Score + Treatment|
1656376|NCT01603940|3048405|Superiority or Other|||||||0.618|||||||Wilcoxon (Mann-Whitney)||||
1656377|NCT01603940|3048406|Superiority or Other|||||||0.28|||||||Wilcoxon (Mann-Whitney)||||
1656378|NCT01603940|3048407|Superiority or Other|||||||0.616|||||||Wilcoxon (Mann-Whitney)||||
1656379|NCT01603628|3048415|Superiority||LS Mean Difference|-1.09||||0.451|2-Sided|95.0|-3.944|1.758||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12|
1656446|NCT01603056|3048514|Superiority or Other|||||||0.391|||||||t-test, 2 sided||||
1656447|NCT01603056|3048515|Superiority or Other|||||||0.818|||||||t-test, 2 sided||||
1656380|NCT01603628|3048415|Superiority||LS Mean Difference|-2.61||||0.078|2-Sided|95.0|-5.517|0.296||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12|
1656381|NCT01603628|3048415|Superiority||LS Mean Difference|-2.46||||0.165|2-Sided|95.0|-5.935|1.014||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8|
1656382|NCT01603628|3048415|Superiority||LS Mean Difference|-2.07||||0.254|2-Sided|95.0|-5.621|1.491||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8|
1656383|NCT01603628|3048415|Superiority||LS Mean Difference|-3.92||||0.006|2-Sided|95.0|-6.688|-1.148||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6|
1656384|NCT01603628|3048415|Superiority||LS Mean Difference|-3.33||||0.02|2-Sided|95.0|-6.143|-0.525||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6|
1656385|NCT01603628|3048415|Superiority||LS Mean Difference|-2.11||||0.171|2-Sided|95.0|-5.127|0.914||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4|
1656386|NCT01603628|3048415|Superiority||LS Mean Difference|-1.42||||0.363|2-Sided|95.0|-4.489|1.648||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4|
1656387|NCT01603628|3048415|Superiority||LS Mean Difference|-3.25||||0.02|2-Sided|95.0|-5.974|-0.524||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2|
1656388|NCT01603628|3048415|Superiority||LS Mean Difference|-1.99||||0.158|2-Sided|95.0|-4.768|0.779||ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2|
1656389|NCT01603628|3048416|Superiority||LS Mean Difference|0.27||||0.078|2-Sided|95.0|-0.031|0.571||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Passive Goal|
1656390|NCT01603628|3048416|Superiority||LS Mean Difference|0.41||||0.01|2-Sided|95.0|0.1|0.711||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Passive Goal|
1656391|NCT01603628|3048416|Superiority||LS Mean Difference|0.22||||0.153|2-Sided|95.0|-0.081|0.541||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Active Goal|
1656392|NCT01603628|3048416|Superiority||LS Mean Difference|0.49||||0.001|2-Sided|95.0|0.191|0.797||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 12, Active Goal|
1656393|NCT01603628|3048416|Superiority||LS Mean Difference|0.44||||0.004|2-Sided|95.0|0.141|0.74||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Passive Goal|
1656394|NCT01603628|3048416|Superiority||LS Mean Difference|0.45||||0.004|2-Sided|95.0|0.145|0.756||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Passive Goal|
1656395|NCT01603628|3048416|Superiority||LS Mean Difference|0.29||||0.047|2-Sided|95.0|0.004|0.573||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Active Goal|
1656396|NCT01603628|3048416|Superiority||LS Mean Difference|0.41||||0.005|2-Sided|95.0|0.126|0.704||ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Week 8, Active Goal|
1656397|NCT01603628|3048417|Superiority||LS Mean Difference|0.13||||0.299|2-Sided|95.0|-0.115|0.374||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures||||
1656398|NCT01603628|3048417|Superiority||LS Mean Difference|0.29||||0.023|2-Sided|95.0|0.04|0.532||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures||||
1656448|NCT01603056|3048516|Superiority or Other|||||||0.641|||||||t-test, 2 sided||||
1656449|NCT01603056|3048517|Superiority or Other|||||||0.74|||||||t-test, 2 sided||||
1656399|NCT01603628|3048418|Superiority||LS Mean Difference|-0.21||||0.033|2-Sided|95.0|-0.405|-0.018||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures||||
1656400|NCT01603628|3048418|Superiority||Least Squares (LS) Mean Difference|-0.26||||0.01|2-Sided|95.0|-0.453|-0.063||MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.|Mixed Model Repeated Measures||||
1656401|NCT01603602|3048420|Superiority||LS Mean Difference|-13.52||||0.046|2-Sided|95.0|-26.797|-0.243||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Wrist|
1656402|NCT01603602|3048420|Superiority||LS Mean Difference|-15.25||||0.02|2-Sided|95.0|-28.01|-2.492||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Wrist|
1656403|NCT01603602|3048420|Superiority||LS Mean Difference|-15.74||||0.015|2-Sided|95.0|-28.293|-3.194||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Wrist|
1656404|NCT01603602|3048420|Superiority||LS Mean Difference|-17.71||||0.005|2-Sided|95.0|-29.888|-5.537||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Wrist|
1656405|NCT01603602|3048420|Superiority||LS Mean Difference|-11.25||||0.098|2-Sided|95.0|-24.622|2.131||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Wrist|
1656406|NCT01603602|3048420|Superiority||LS Mean Difference|-17.11||||0.01|2-Sided|95.0|-30.031|-4.189||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Wrist|
1656407|NCT01603602|3048420|Superiority||LS Mean Difference|-13.1||||0.051|2-Sided|95.0|-26.26|0.068||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Wrist|
1656408|NCT01603602|3048420|Superiority||LS Mean Difference|-10.64||||0.098|2-Sided|95.0|-23.277|1.996||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Wrist|
1656409|NCT01603602|3048420|Superiority||LS Mean Difference|-14.6||||0.012|2-Sided|95.0|-25.846|-3.36||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Wrist|
1656410|NCT01603602|3048420|Superiority||LS Mean Difference|-6.13||||0.263|2-Sided|95.0|-16.962|4.706||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Wrist|
1656411|NCT01603602|3048420|Superiority||LS Mean Difference|3.86||||0.47|2-Sided|95.0|-6.69|14.419||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Elbow|
1656412|NCT01603602|3048420|Superiority||LS Mean Difference|4.5||||0.409|2-Sided|95.0|-6.239|15.236||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 12, Elbow|
1656413|NCT01603602|3048420|Superiority||LS Mean Difference|7.22||||0.225|2-Sided|95.0|-4.488|18.934||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Elbow|
1656414|NCT01603602|3048420|Superiority||LS Mean Difference|15.25||||0.013|2-Sided|95.0|3.317|27.178||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 8, Elbow|
1656415|NCT01603602|3048420|Superiority||LS Mean Difference|11.35||||0.064|2-Sided|95.0|-0.662|23.362||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Elbow|
1656416|NCT01603602|3048420|Superiority||LS Mean Difference|20.97|||<|0.001|2-Sided|95.0|8.801|33.137||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 6, Elbow|
1656417|NCT01603602|3048420|Superiority||LS Mean Difference|11.85|||<|0.046|2-Sided|95.0|0.203|23.504||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Elbow|
1656418|NCT01603602|3048420|Superiority||LS Mean Difference|14.71|||<|0.015|2-Sided|95.0|2.958|26.458||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 4, Elbow|
1656450|NCT01603056|3048518|Superiority or Other|||||||0.627|||||||t-test, 2 sided||||
1656451|NCT01603056|3048519|Superiority or Other|||||||0.743|||||||t-test, 2 sided||||
1656419|NCT01603602|3048420|Superiority||LS Mean Difference|8.41|||<|0.273|2-Sided|95.0|-6.717|23.527||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Elbow|
1656420|NCT01603602|3048420|Superiority||LS Mean Difference|12.1|||<|0.117|2-Sided|95.0|-3.089|27.293||ANCOVA model including baseline MTS as a covariate and factors of age group, treatment group, study center and botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA|||Change from Baseline to Week 2, Elbow|
1656421|NCT01603602|3048421|Superiority||LS Mean Difference|0.19||||0.327|2-Sided|95.0|-0.194|0.58||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Passive Goal|
1656422|NCT01603602|3048421|Superiority||LS Mean Difference|0.59||||0.003|2-Sided|95.0|0.21|0.978||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Passive Goal|
1656423|NCT01603602|3048421|Superiority||LS Mean Difference|-0.25||||0.2|2-Sided|95.0|-0.641|0.135||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Active Goal|
1656424|NCT01603602|3048421|Superiority||LS Mean Difference|-0.02||||0.904|2-Sided|95.0|-0.408|0.361||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 12, Active Goal|
1656425|NCT01603602|3048421|Superiority||LS Mean Difference|0.17||||0.412|2-Sided|95.0|-0.237|0.576||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Passive Goal|
1656426|NCT01603602|3048421|Superiority||LS Mean Difference|0.24||||0.243|2-Sided|95.0|-0.162|0.635||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Passive Goal|
1656427|NCT01603602|3048421|Superiority||LS Mean Difference|-0.09||||0.658|2-Sided|95.0|-0.502|0.318||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Active Goal|
1656428|NCT01603602|3048421|Superiority||LS Mean Difference|-0.1||||0.636|2-Sided|95.0|-0.498|0.305||ANCOVA model including baseline MAS-B score as a covariate; factors of age, principal muscle group, treatment, study center and previous botulinum toxin exposure where age and principal muscle group were represented by stratification categories.|ANCOVA|||Week 8, Active Goal|
1656429|NCT01603602|3048422|Superiority||LS Mean Difference|-0.44||||0.078|2-Sided|95.0|-0.933|0.051||ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA||||
1656430|NCT01603602|3048422|Superiority||LS Mean Difference|-0.39||||0.111|2-Sided|95.0|-0.861|0.091||ANCOVA model including baseline MAS-B score of finger flexor muscle group as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.|ANCOVA||||
1656431|NCT01603602|3048423|Superiority||LS Mean Difference|0.22||||0.147|2-Sided|95.0|-0.079|0.523||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM||||
1656432|NCT01603602|3048423|Superiority||LS Mean Difference|0.21||||0.155|2-Sided|95.0|-0.082|0.511||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM||||
1656433|NCT01603602|3048424|Superiority||LS Mean Difference|-0.71|||<|0.001|2-Sided|95.0|-0.992|-0.426||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|MMRM||||
1656434|NCT01603602|3048424|Superiority||Least Squares (LS) Mean Difference|-0.66|||<|0.001|2-Sided|95.0|-0.938|-0.379||MMRM model with baseline MAS-B score as covariate; factors of age, principal muscle group, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure, stratified by age and principal muscle group categories.|Mixed Model Repeated Measures (MMRM)||||
1656435|NCT01603368|3048482|Other|Student's t-test|||||=|0|||||||t-test, 2 sided||||
1656436|NCT01603082|3048506|Superiority or Other||Mean Difference (Final Values)|-43.6|Standard Error of the Mean|16.5||0.01|2-Sided|95.0|-76.5|-10.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at end of PCI.|
1656437|NCT01603082|3048506|Superiority or Other||Mean Difference (Final Values)|-158.5|Standard Error of the Mean|15.5|<|0.001|2-Sided|95.0|-189.4|-127.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at 8 hours after the loading dose.|
1656438|NCT01603082|3048506|Superiority or Other||Mean Difference (Final Values)|-20.4|Standard Error of the Mean|15.2|<|0.182|2-Sided|95.0|-50.5|9.7|||t-test, 2 sided||Ticagrelor minus clopidogrel.|Analysis at 0.5 hours after the loading dose|
1656439|NCT01603082|3048507|Superiority or Other||Mean Difference (Final Values)|-159.1|Standard Error of the Mean|17.9|<|0.001|2-Sided|95.0|-194.7|-123.5|||t-test, 2 sided||Ticagrelor minus clopidogrel.||
1656440|NCT01603056|3048508|Superiority or Other|||||||0.719|||||||t-test, 2 sided||||
1656441|NCT01603056|3048509|Superiority or Other|||||||0.123|||||||t-test, 2 sided||||
1656442|NCT01603056|3048510|Superiority or Other|||||||0.465|||||||t-test, 2 sided||||
1656443|NCT01603056|3048511|Superiority or Other|||||||0.438|||||||Fisher Exact||||
1656452|NCT01602614|3048535|Other|Spearman Rank Correlation||||||0.5868||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.|
1656453|NCT01602614|3048536|Other|Spearman Rank Correlation||||||0.7292||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.|
1656454|NCT01602614|3048537|Other|Spearman Rank Correlation||||||0.4845||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.|
1656455|NCT01602614|3048538|Other|Spearman Rank Correlation||||||0.1591||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.|
1656456|NCT01602614|3048539|Other|Spearman Rank Correlation||||||0.6476|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.|
1656457|NCT01602614|3048540|Other|Spearman Rank Correlation||||||0.7787|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.|
1656458|NCT01602614|3048541|Other|Spearman Rank Correlation||||||0.6967|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.|
1656459|NCT01602614|3048542|Other|Spearman Rank Correlation||||||0.9484||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.|
1656460|NCT01602614|3048543|Other|Spearman Rank Correlation||||||0.8799||||||Spearman Rank Correlation|Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.|
1656461|NCT01602614|3048544|Other|Spearman Rank Correlation||||||0.5258|||||||Spearman Rank Correlation|||No subjects were enrolled in Group 1 and Group 4. One subject in Group 3 did not collect full PK panel therefore no pk was analyzed for this subject.|
1656462|NCT01602562|3048564|Superiority or Other||percentage of participants|0.0|||||2-Sided|95.0|0.0|17.65|||||The estimated value reflects the percentage of participants with an HSV infection.||
1656463|NCT01602562|3048564|Superiority or Other||percentage of participants|0.0|||||2-Sided|95.0|0.0|16.11|||||The estimated value reflects the percentage of participants with an HSV infection.||
1656464|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|4.08|||||2-Sided|95.0|-14.91|23.07|||||Day 8, 240 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 8|
1656465|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|3.02|||||2-Sided|95.0|-15.98|22.02|||||Day 8, 180 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 8|
1656466|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|-0.71|||||2-Sided|95.0|-19.7|18.28|||||Day 8, 120 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 8|
1656467|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|-1.38|||||2-Sided|95.0|-20.4|17.63|||||Day 8, 90 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|90 min PD: GSK962040 50 mg Vs Placebo Day 8|
1656468|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|-3.12|||||2-Sided|95.0|-22.13|15.88|||||Day 8, 60 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|60 min PD: GSK962040 50 mg Vs Placebo Day 8|
1656469|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|-2.94|||||2-Sided|95.0|-21.97|16.08|||||Day 8, 30 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|30 min PD: GSK962040 50 mg Vs Placebo Day 8|
1656470|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|3.32|||||2-Sided|95.0|-15.7|22.33|||||Day 8, 0 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|0 min PD: GSK962040 50 mg Vs Placebo Day 8|
1656471|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|0.51|||||2-Sided|95.0|-18.51|19.52|||||Day 8, pre-dose: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Pre-dose: GSK962040 50 mg Vs Placebo Day 8|
1656472|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|0.77|||||2-Sided|95.0|-18.2|19.75|||||Day 1, 240 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 1|
1656473|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|-6.39|||||2-Sided|95.0|-25.36|12.58|||||Day 1, 180 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 1|
1656474|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|-4.18|||||2-Sided|95.0|-23.13|14.76|||||Day 1, 120 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 1|
1656475|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|-3.38|||||2-Sided|95.0|-22.35|15.58|||||Day 1, 90 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|90 min PD: GSK962040 50 mg Vs Placebo Day 1|
1656476|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|0.28|||||2-Sided|95.0|-18.72|19.28|||||Day 1, 60 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|60 min PD: GSK962040 50 mg Vs Placebo Day 1|
1656477|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|1.84|||||2-Sided|95.0|-17.18|20.86|||||Day 1, 30 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Day 1, 30 min PD|
1656478|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|0.58|||||2-Sided|95.0|-18.39|19.56|||||Day 1, 0 min PD: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|0 min PD: GSK962040 50 mg Vs Placebo Day 1|
1656479|NCT01602549|3048584|Superiority or Other||Difference in AMs of change from BL|-2.83|||||2-Sided|95.0|-21.79|16.13|||||Day 1, pre-dose: The AMs/differences (GSK962040 minus Placebo) were estimated using a MM fitting treatment, visit, time point (TP), treatment*visit*TP interaction, and BL score as fixed effects, TP as a repeated effect, and par. as a random effect.|Pre-dose: Day GSK962040 50 mg Vs Placebo Day 1|
1656480|NCT01602549|3048585|Superiority or Other||Difference in AMs of change from BL|1.88|||||2-Sided|95.0|0.28|3.48|||||ON: Treatment Period: The AMs and differences (GSK962040 minus Placebo) were estimated using an analysis of covariance (ANCOVA) model fitting treatment and Baseline amount of hours spent ON/OFF as main effects.|ON: Treatment Period|
1656481|NCT01602549|3048585|Superiority or Other||Difference in AMs of change from BL|-2.31|||||2-Sided|95.0|-3.71|-0.9|||||OFF: Treatment Period: The AMs and differences (GSK962040 minus Placebo) were estimated using an analysis of covariance (ANCOVA) model fitting treatment and Baseline amount of hours spent ON/OFF as main effects.|OFF: Treatment Period|
1656482|NCT01602549|3048586|Superiority or Other||Difference in AMs of change from BL|-8.9|||||2-Sided|95.0|-14.88|-2.91|||||Day 8; 240 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 8|
1656483|NCT01602549|3048586|Superiority or Other||Difference in AMs of change from BL|-5.29|||||2-Sided|95.0|-11.29|0.71|||||Day 8; 180 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 8|
1656484|NCT01602549|3048586|Superiority or Other||Difference in AMs of change from BL|-3.97|||||2-Sided|95.0|-9.96|2.03|||||Day 8; 120 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 8|
1656485|NCT01602549|3048586|Superiority or Other||Difference in AMs of change from BL|-6.8|||||2-Sided|95.0|-12.79|-0.81|||||Day 8; Pre-dose: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|Pre dose: GSK962040 50 mg Vs Placebo Day 8|
1656486|NCT01602549|3048586|Superiority or Other||Difference in AMs of change from BL|-4.15|||||2-Sided|95.0|-10.07|1.76|||||Day 1; 240 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|240 min PD: GSK962040 50 mg Vs Placebo Day 1|
1656487|NCT01602549|3048586|Superiority or Other||Difference in AMs of change from BL|-3.66|||||2-Sided|95.0|-9.59|2.27|||||Day 1; 180 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|180 min PD: GSK962040 50 mg Vs Placebo Day 1:|
1656488|NCT01602549|3048586|Superiority or Other||Difference in AMs of change from BL|-3.18|||||2-Sided|95.0|-9.11|2.75|||||Day 1; 120 min PD: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|120 min PD: GSK962040 50 mg Vs Placebo Day 1|
1656489|NCT01602549|3048586|Superiority or Other||Difference in AMs of change from BL|-3.14|||||2-Sided|95.0|-9.07|2.78|||||Day 1; Pre-dose: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit*time point interaction, and Baseline UPDRS-3 score as fixed effects, and participant as a random effect.|Pre dose: GSK962040 50 mg Vs Placebo Day 1|
1656490|NCT01602549|3048587|Superiority or Other||Difference in AMs of change from BL|-1.7|||||2-Sided|95.0|-6.53|3.13|||||Day 1; Part III: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part III- GSK962040 50 mg Vs Placebo Day 1|
1656491|NCT01602549|3048587|Superiority or Other||Difference in AMs of change from BL|-12.5|||||2-Sided|95.0|-19.67|-5.29|||||Day 8; Total: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Total- GSK962040 50 mg Vs Placebo Day 8|
1656492|NCT01602549|3048587|Superiority or Other||Difference in AMs of change from BL|-6.69|||||2-Sided|95.0|-13.77|0.39|||||Day 1; Total: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Total- GSK962040 50 mg Vs Placebo Day 1|
1656493|NCT01602549|3048587|Superiority or Other||Difference in AMs of change from BL|-0.9|||||2-Sided|95.0|-2.02|0.22|||||Day 8; Part IV: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part IV-GSK962040 50 mg Vs Placebo Day 8|
1656494|NCT01602549|3048587|Superiority or Other||Difference in AMs of change from BL|-0.56|||||2-Sided|95.0|-1.65|0.54|||||Day 1; Part IV: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part IV-GSK962040 50 mg Vs Placebo Day 1|
1656495|NCT01602549|3048587|Superiority or Other||Difference in AMs of change from BL|-5.38|||||2-Sided|95.0|-10.28|-0.49|||||Day 8; Part III: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part III -GSK962040 50 mg Vs Placebo Day 8|
1656496|NCT01602549|3048587|Superiority or Other||Difference in AMs of change from BL|-2.46|||||2-Sided|95.0|-4.85|-0.07|||||Day 8; Part II: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part II- GSK962040 50 mg Vs Placebo Day 8|
1656497|NCT01602549|3048587|Superiority or Other||Difference in AMs of change from BL|-2.29|||||2-Sided|95.0|-4.65|0.07|||||Day 1; Part II: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part II- GSK962040 50 mg Vs Placebo Day 1|
1656498|NCT01602549|3048587|Superiority or Other||Difference in AMs of change from BL|-3.63|||||2-Sided|95.0|-5.41|-1.85|||||Day 8; Part I: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part I-GSK962040 50 mg Vs Placebo Day 8|
1656499|NCT01602549|3048587|Superiority or Other||Difference in AMs of change from BL|-2.16||||||95.0|-3.9|-0.41|||||Day 1; Part I: The AMs and differences (GSK 962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit interaction, and Baseline MDS-UPDR score as fixed effects, and participant as a random effect.|Part I-GSK962040 50 mg Vs Placebo Day 1|
1656500|NCT01602549|3048588|Superiority or Other||Difference in AMs of change from BL|-5.327|||||2-Sided|95.0|-17.567|6.914|||||Day 8: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit, and Baseline gastric half emptying time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 8|
1656501|NCT01602549|3048588|Superiority or Other||Difference in AMs of change from BL|-4.239|||||2-Sided|95.0|-16.015|7.537|||||Day 1: The AMs and differences (GSK962040 minus Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit, and Baseline gastric half emptying time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 1|
1656502|NCT01602549|3048590|Superiority or Other|||||||0.186|||||||Wilcoxon rank-sum test|||Day 8|
1656503|NCT01602549|3048590|Superiority or Other|||||||0.157|||||||Wilcoxon rank-sum test|||Day 1|
1656504|NCT01602549|3048591|Superiority or Other||Ratio of adjusted geometric means|0.865|||||2-Sided|95.0|0.709|1.055|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8 Vs Day 1 Placebo|
1656505|NCT01602549|3048591|Superiority or Other||Ratio of adjusted geometric means|1.018|||||2-Sided|95.0|0.889|1.166|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8 VS Day 1 GSK962040 50 mg|
1656506|NCT01602549|3048591|Superiority or Other||Ratio of adjusted geometric means|1.018|||||2-Sided|95.0|0.824|1.257|||||Day 8: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 8|
1656507|NCT01602549|3048591|Superiority or Other||Ratio of adjusted geometric means|0.864|||||2-Sided|95.0|0.702|1.064|||||Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg Vs Placebo Day 1|
1656508|NCT01602549|3048593|Superiority or Other||Ratio of adjusted geometric means|1.02|||||2-Sided|95.0|0.89|1.17|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8:Day 1 Placebo|
1656509|NCT01602549|3048593|Superiority or Other||Ratio of adjusted geometric means|0.937|||||2-Sided|95.0|0.85|1.033|||||Day 8:Day 1: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|Day 8: Day 1|
1656510|NCT01602549|3048593|Superiority or Other||Ratio of adjusted geometric means|0.886|||||2-Sided|95.0|0.763|1.029|||||Day 8: The AMs and ratios were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg : Placebo Day 8|
1656511|NCT01602549|3048593|Superiority or Other||Ratio of adjusted geometric means|0.965|||||2-Sided|95.0|0.831|1.12|||||Day 1: The adjusted means (AMs) and ratios were estimated using a mixed model (MM) fitting treatment, visit, treatment*visit, Baseline L-dopa PK parameter and Baseline gastric emptying half time as fixed effects, and participant as a random effect.|GSK962040 50 mg : Placebo Day 1|
1656512|NCT01602510|3048595|Superiority or Other||Mean Difference (Final Values)|-0.84|||=|0|2-Sided|95.0|-1.66|-0.01|||ANCOVA||||
1656513|NCT01602510|3048596|Superiority or Other||Mean Difference (Final Values)|-0.1|||=|0|2-Sided|95.0|-3.7|3.5|||ANCOVA||||
1656514|NCT01602510|3048597|Superiority or Other||Mean Difference (Final Values)|0.4|||=|0|2-Sided|95.0|-1.4|2.2|||ANCOVA||||
1656515|NCT01602510|3048598|Superiority or Other||Mean Difference (Final Values)|-1.2|||=|0|2-Sided|95.0|-3.0|0.5|||ANCOVA||||
1656516|NCT01602510|3048599|Superiority or Other||Mean Difference (Final Values)|-0.2|||=|0|2-Sided|95.0|-0.5|0.1|||ANCOVA||||
1656517|NCT01602510|3048600|Superiority or Other||Mean Difference (Final Values)|0.0|||=|0|2-Sided|95.0|-0.4|0.5|||ANCOVA||||
1656518|NCT01602510|3048601|Superiority or Other||Adjusted Hazard Ratio|1.02|||=|0|2-Sided|95.0|0.73|1.4|||Regression, Cox||p value with CGI-S Baseline Score as covariate||
1656519|NCT01602510|3048601|Superiority or Other||Adjusted Hazard Ratio|1.02|||=|0|2-Sided|95.0|0.73|1.4|||Regression, Cox||p value with Site as covariate||
1656520|NCT01602510|3048601|Superiority or Other||Adjusted Hazard Ratio|1.02|||=|0|2-Sided|95.0|0.73|1.4|||Regression, Cox||p value with Treatment Group as covariate||
1656521|NCT01602510|3048602|Superiority or Other||Adjusted Hazard Ratio|0.79|||=|0|2-Sided|95.0|0.48|1.32|||Regression, Cox||p value with CGI-S Baseline Score as covariate||
1656522|NCT01602510|3048602|Superiority or Other||Adjusted Hazard Ratio|0.79|||=|0|2-Sided|95.0|0.48|1.32|||Regression, Cox||p value with Site as covariate||
1656523|NCT01602510|3048602|Superiority or Other||Adjusted Hazard Ratio|0.79|||=|0|2-Sided|95.0|0.48|1.32|||Regression, Cox||p value with Treatment Group as covariate||
1656524|NCT01602510|3048603|Superiority or Other||Adjusted Hazard Ratio|0.95|||=|0|2-Sided|95.0|0.55|1.66|||Regression, Cox||p value with CGI-S Baseline Score as covariate||
1656525|NCT01602510|3048603|Superiority or Other||Adjusted Hazard Ratio|0.95|||=|0|2-Sided|95.0|0.55|1.66|||Regression, Cox||p value with Site as covariate||
1656526|NCT01602510|3048603|Superiority or Other||Adjusted Hazard Ratio|0.95|||=|0|2-Sided|95.0|0.55|1.66|||Regression, Cox||p value with Treatment Group as covariate||
1656527|NCT01602510|3048604|Superiority or Other||Adjusted Hazard Ratio|0.86|||=|0|2-Sided|95.0|0.59|1.25|||Regression, Cox||p value with CGI-S Baseline Score as covariate||
1656528|NCT01602510|3048604|Superiority or Other||Adjusted Hazard Ratio|0.86|||=|0|2-Sided|95.0|0.59|1.25|||Regression, Cox||p value with Site as covariate||
1656529|NCT01602510|3048604|Superiority or Other||Adjusted Hazard Ratio|0.86|||=|0|2-Sided|95.0|0.59|1.25|||Regression, Cox||p value with Treatment Group as covariate||
1656530|NCT01602380|3048638|Superiority or Other (legacy)||Hazard Ratio (HR)|0.84||||0.1594|2-Sided|95.0|0.66|1.07||2-sided p-value|Log Rank|||Comparative statistical analysis for time to deterioration of FACT-B total score is presented (fulvestrant versus anastrozole).|
1656531|NCT01602380|3048638|Superiority or Other (legacy)||Hazard Ratio (HR)|0.9||||0.4008|2-Sided|95.0|0.7|1.15||2-sided p-value|Log Rank|||Comparative statistical analysis for time to deterioration of TOI score is presented (fulvestrant versus anastrozole).|
1656532|NCT01602380|3048639|Superiority or Other (legacy)||Ratio of EDoCB|1.26||||0.0561||95.0|0.99|1.59||2-sided p-value|Method of Ellis et al||||
1656533|NCT01602380|3048641|Superiority or Other (legacy)||Odds Ratio (OR)|1.253||||0.3045|2-Sided|95.0|0.815|1.932||2-sided p-value|Regression, Logistic||||
1656534|NCT01602380|3048642|Superiority or Other (legacy)||Rato of EDoR|1.52||||0.0367|2-Sided|95.0|1.03|2.26||2-sided p-value|Method of Ellis et al||||
1656535|NCT01602380|3048644|Superiority or Other (legacy)||Odds Ratio (OR)|1.074||||0.729|2-Sided|95.0|0.716|1.614||2-sided p-value|Regression, Logistic||||
1656536|NCT01602380|3048645|Superiority or Other (legacy)||Hazard Ratio (HR)|0.875||||0.4277|2-Sided|95.0|0.629|1.217||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.|A hazard ratio of <1 favours fulvestrant.|OS data were immature at the time of the interim analysis (31%), to the extent that median OS could not be calculated. A further analysis of OS will be conducted when these data are more mature.|
1656537|NCT01602380|3048646|Superiority or Other (legacy)||Hazard Ratio (HR)|0.797||||0.0486|2-Sided|95.0|0.637|0.999||2-sided p-value|Log Rank|Stratified log-rank test with factors for prior chemotherapy for locally advanced or metastatic disease and measurable disease at baseline.|A hazard ratio < 1 favours fulvestrant.|If the true PFS HR for comparison of fulvestrant vs. anastrozole was 0.69 (likely to correspond to a 45% prolongation of PFS) the study had 90% power to demonstrate a statistically significant difference for PFS with a one-sided type 1 error of 2.5% (two-sided 5%).|
1656538|NCT01602315|3048657|Superiority or Other||Hazard Ratio (HR)|0.64||||0.062|2-Sided|95.0|0.4|1.02|||Regression, Cox|||Adjusted on Covariates: treatment, sum of longest diameters from local data [SLD (L)], Hemaglobin (Hgb) and White Blood Cells (WBC).|
1656539|NCT01602315|3048657|Superiority or Other||Hazard Ratio (HR)|0.76||||0.235|2-Sided|95.0|0.49|1.19|||Regression, Cox||||
1656540|NCT01602315|3048671|Superiority or Other||Kaplan-Meier (median)|294.0|||||2-Sided|95.0|172.0|463.0|||||||
1656541|NCT01602315|3048672|Superiority or Other||Hazard Ratio (HR)|1.28||||0.313|2-Sided|95.0|0.79|2.05|||Regression, Cox||||
1656542|NCT01602315|3048678|Superiority or Other||Kaplan-Meier method (median)|43.0|||||2-Sided|95.0|27.0|88.0|||||days||
1656543|NCT01602315|3048681|Superiority or Other||Hazard Ratio (HR)|0.54||||0.039|2-Sided|95.0|0.3|0.97|||Regression, Cox|||Adjusted on Covariates: treatment, sum of longest diameters from central data [SLD (C)], Hemaglobin (Hgb) and White Blood Cells (WBC).|
1656544|NCT01602315|3048681|Superiority or Other||Hazard Ratio (HR)|1.12||||0.643|2-Sided|95.0|0.69|1.82|||Regression, Cox||||
1656545|NCT01602315|3048681|Superiority or Other||median HR|0.99||||||||||||||The hazard ratio was estimated using the Bayesian Cox proportional hazard (PH) model.|
1656546|NCT01602224|3048686|Superiority||Odds Ratio (OR)|1.9||||0.419|2-Sided||||||Regression, Logistic|||100 mg Tabalumab+Dexamethasone+Bortezomib and 300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only compared to placebo.|
1656547|NCT01602224|3048686|Superiority||Odds Ratio (OR)|1.84||||0.455|2-Sided||||||Regression, Logistic|||300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.|
1656548|NCT01602224|3048686|Superiority||Odds Ratio (OR)|1.98||||0.401|2-Sided||||||Regression, Logistic|||100 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.|
1656549|NCT01602172|3048704|Equivalence|Results of the regression models were used to reject null hypotheses of equivalence with p-values of comparisons across groups in changes in alcohol related measures using p-values < 0.05 as significant.||||||0.05||||||First, significance of the regression model was viewed. When the overall model was significant, tests of the co-efficients were viewed. Primary effects of interest were the treatment group X time interactions.|Mixed Models Analysis|||Measures were compared with linear mixed effects regression models to compare impact of BI compared to usual care conditions. Analyses reported here included only those that completed the 6 month interview (71/82 baseline participants).|
1656550|NCT01601873|3048721|Superiority|||||||0.185|||||||Log Rank||||
1656551|NCT01601873|3048722|Superiority|||||||0.786|||||||Log Rank||||
1656552|NCT01601873|3048723|Superiority|||||||0.538|||||||Log Rank||||
1656553|NCT01601873|3048724|Superiority|||||||0.294|||||||Wilcoxon (Mann-Whitney)||||
1656554|NCT01601873|3048725|Superiority|||||||0.946|||||||Wilcoxon (Mann-Whitney)||||
1656555|NCT01601873|3048726|Superiority|||||||0.884|||||||Wilcoxon (Mann-Whitney)||||
1656556|NCT01601847|3048727|Superiority|||||||0.798|||||||Regression, Logistic||||
1656557|NCT01601847|3048728|Superiority|||||||0.228|||||||Regression, Logistic|||For secondary outcomes, GEE is used to assess randomization arm association.|
1656558|NCT01601847|3048729|Superiority||Odds Ratio (OR)|0.522||||0.0185|2-Sided|95.0|0.304|0.897|||logistic regression with GEE||||
1656559|NCT01601847|3048729|Superiority||Risk Ratio (RR)|0.66||||0.02|2-Sided|95.0|0.47|0.94|||Poisson|Poisson regression using GEE with robust variance estimation (e.g. Zou, American Journal Epidemiology, 2004)|||
1656560|NCT01601821|3048730|Superiority or Other|||||||0.978||||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.|
1656561|NCT01601821|3048731|Superiority or Other|||||||0.172||||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher’s exact test was used to test the difference.|
1656562|NCT01601821|3048732|Superiority or Other|||||||0.985||||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.|
1656563|NCT01601821|3048733|Superiority or Other|||||||0.999||||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher’s exact test was used to test the difference.|
1656564|NCT01601821|3048734|Superiority or Other|||||||0.868||||||Statistical testing was based on 5% significance level.|Chi-squared|||Chi-square test was used to test the difference.|
1656565|NCT01601821|3048735|Superiority or Other|||||||0.999||||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher’s exact test was used to test the difference.|
1656566|NCT01601821|3048736|Superiority or Other|||||||0.276||||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher’s exact test was used to test the difference.|
1656567|NCT01601821|3048738|Superiority or Other|||||||0.999||||||Statistical testing was based on 5% significance level.|Fisher Exact|||Fisher’s exact test was used to test the difference.|
1656568|NCT01601821|3048739|Superiority or Other|||||||0.977||||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.|
1656569|NCT01601821|3048739|Superiority or Other|||||||0.738||||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.|
1656570|NCT01601821|3048739|Superiority or Other|||||||0.786||||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way ANOVA was used to test the difference.|
1656571|NCT01601821|3048740|Superiority or Other|||||||0.518||||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.|
1656572|NCT01601821|3048740|Superiority or Other|||||||0.66||||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.|
1656573|NCT01601821|3048740|Superiority or Other|||||||0.979||||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way ANOVA was used to test the difference.|
1656574|NCT01601821|3048741|Superiority or Other|||||||0.096||||||Statistical testing was based on 5% significance level.|ANOVA|||Month 12: One-way ANOVA was used to test the difference.|
1656575|NCT01601821|3048741|Superiority or Other|||||||0.381||||||Statistical testing was based on 5% significance level.|ANOVA|||Month 6: One-way ANOVA was used to test the difference.|
1656576|NCT01601821|3048741|Superiority or Other|||||||0.87||||||Statistical testing was based on 5% significance level.|ANOVA|||Month 3: One-way analysis of variance (ANOVA) was used to test the difference.|
1656577|NCT01601821|3048742|Superiority or Other||percent difference|-2.0||||0.341|2-Sided|90.0|-5.5|1.5|||Chi-squared|||Chi-square test was used to test superiority of arm CsA+Rapamune+CS versus arm CsA+MMF+CS.|
1656578|NCT01601704|3048744|Superiority or Other||Cox Proportional Hazard|1.04|||||2-Sided|99.7|0.43|2.55|||||Hazard ratio is based on CPH model with treatment as a factor.||
1656579|NCT01601704|3048745|Superiority or Other||Cox Proportional Hazard|0.96|||||2-Sided|99.7|0.55|1.67|||||Hazard ratio is based on CPH model with treatment as a factor.||
1656580|NCT01601704|3048746|Superiority or Other||Cox Proportional Hazard|0.5|||||2-Sided|99.7|0.21|1.19|||||Hazard ratio is based on CPH model with treatment as a factor.||
1656581|NCT01601704|3048747|Superiority or Other||Cox Proportional Hazard|0.93|||||2-Sided|99.7|0.66|1.33|||||Hazard ratio is based on CPH model with treatment as a factor.||
1656582|NCT01601704|3048748|Non-Inferiority or Equivalence|At the pre-planned 50% interim analysis, a non-inferiority analysis was conducted based on the estimated hazard ratio (NB32/Placebo) for the time to the first confirmed occurrence of MACE. The upper-bound of the 99.7% confidence interval for the hazard ratio was compared to 1.4, the non-inferiority margin.|Cox Proportional Hazard|0.88|||||2-Sided|99.7|0.57|1.34|||||Hazard ratio is based on CPH model with treatment as a factor.||
1656583|NCT01601535|3048779|Other|||||||1||||||AurkA Codon 57 Summary H vs. AurkA Codon 57 Summary W|Fisher Exact||||
1657009|NCT01597245|3049340|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1656584|NCT01601535|3048779|Other|||||||0.9||||||AurkA Codon 31 Summary H vs. AurkA Codon 31 Summary V vs. AurkA Codon 31 Summary W|Fisher Exact||||
1656585|NCT01601535|3048780|Other|||||||0.63||||||UGT1A1 6\6 vs. UGT1A1 6\7 vs. UGT1A1 7\7|Fisher Exact||||
1656586|NCT01601535|3048780|Other|||||||0.094||||||UGT1A1 6\6 vs. UGT1A1 6\7 vs. UGT1A1 7\7|Fisher Exact||||
1656587|NCT01601535|3048781|Other|||||||1|||||||Fisher Exact|Aurora A protein Positive vs. Aurora A protein Negative|||
1656588|NCT01601535|3048781|Other|||||||0.21|||||||Fisher Exact|MYCN Amplified or Myc Positive vs. MYCN Non-amplified and Myc Negative|||
1656589|NCT01601535|3048781|Other|||||||0.14||||||MYCN Amplified vs. MYCN not Amplified|Fisher Exact||||
1656590|NCT01601132|3048812|Superiority or Other||Ratio (%) (Test/Reference)|98.59|||||2-Sided|90.0|90.97|106.85|||||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed Vd/F, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed Vd/F to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.|
1656591|NCT01601132|3048813|Superiority or Other||Ratio (%) (Test/Reference)|93.96|||||2-Sided|90.0|89.25|98.92|||||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed CL/F, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed CL/F to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.|
1656592|NCT01601132|3048814|Superiority or Other||Ratio (%) (Test/Reference)|106.43|||||2-Sided|90.0|101.1|112.04|||||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed AUC(0-∞) , expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed AUC(0-∞) to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.|
1656593|NCT01601132|3048815|Superiority or Other||Ratio (%) (Test/Reference)|105.63|||||2-Sided|90.0|101.81|109.59|||||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed AUC(0-t)], expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed AUC(0-t) to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, AUC0-∞, and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.|
1656594|NCT01601132|3048816|Superiority or Other||Ratio (%) (Test/Reference)|105.86|||||2-Sided|90.0|101.77|110.12|||||Ratio (theophylline+colchicine/theophylline) of LSMs calculated using the exponentiation of the difference between treatment LSM from the log-transformed Cmax, expressed as a percentage relative to the reference treatment.|Analysis of variance (ANOVA) was performed on the log-transformed Cmax to calculate least squares mean (LSM) for each treatment. The ANOVA model included sequence, treatment, and treatment within a sequence as fixed effects, and participant as a random effect. The criterion for demonstrating a lack of a clinically significant interaction is a 90% CI for the ratio for AUC0-t, (AUC0-∞), and Cmax to be within the 0.80 to 1.25 interval, representing a maximum of 20% difference between treatments.|
1656595|NCT01601132|3048817|Superiority or Other|||||||0.5663||||||Significant difference defined a priori as p < 0.05|Wilcoxon (Mann-Whitney)||||
1656596|NCT01601067|3048818|Superiority|||||||0.91||||||heavy drinking days|Mixed Models Analysis||||
1656597|NCT01601067|3048819|Superiority|||||||0.002|||||||Mixed Models Analysis||||
1656598|NCT01600495|3048846|Superiority or Other||||||<|0.01|||||||Fisher Exact|||Fisher's exact test|
1656599|NCT01600495|3048848|Superiority or Other|||||||0.25|||||||Wilcoxon (Mann-Whitney)||||
1656600|NCT01600495|3048849|Superiority or Other|||||||0.01|||||||Mixed Models Analysis||||
1656601|NCT01600326|3048857|Superiority||||||>|0.99|||||||Fisher Exact||||
1656602|NCT01600326|3048858|Superiority||||||<|0.0001||||||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison|Tukey|||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison|
1656603|NCT01600326|3048858|Other|Pair-wise comparison at Time point 1 compared to baseline|||||<|0.0001||||||One way repeated measure analysis of variance for outcome of total pain score over time adjusted for treatment with post hoc Tukey correction to adjust for multiple comparison|Tukey|See comments on P value|||
1656604|NCT01600092|3048917|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is >0.67|GMT Ratio (Experimental/Existing)|1.16|||||2-Sided|95.0|1.0|1.35|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype P1A[8]|
1656605|NCT01600092|3048917|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is >0.67|GMT Ratio (Experimental/Existing)|1.06|||||2-Sided|95.0|0.94|1.2|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G4|
1657010|NCT01597245|3049340|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1656606|NCT01600092|3048917|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is >0.67|GMT Ratio (Experimental/Existing)|3.2|||||2-Sided|95.0|2.75|3.74|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G3|
1656607|NCT01600092|3048917|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is >0.67|GMT Ratio (Experimental/Existing)|1.15|||||2-Sided|95.0|0.99|1.33|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G2|
1656608|NCT01600092|3048917|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is >0.67|GMT Ratio (Experimental/Existing)|0.92|||||2-Sided|95.0|0.79|1.07|||||GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups|Serotype G1|
1656609|NCT01600014|3048920|Superiority or Other||Mean Difference (Net)|-0.69||||0.008|2-Sided|95.0|-1.19|-0.19||Formal statistical significance could not be established because of the closed test procedure where the first secondary endpoint tested (12 months clearance) did not reach statistical significance in the recurrent subgroup|ANCOVA|Analysed using ANCOVA adjusted for anatomical location, country and AK count at randomisation|Using BOCF as the imputation method, the difference in the adjusted mean AK count between the ingenol mebutate and vehicle groups|The analysis type was superiority between groups. In total 62 subjects were included|
1656610|NCT01600014|3048920|Superiority or Other||Mean Difference (Net)|-1.01|||<|0.001|2-Sided|95.0|-1.52|-0.51||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|ANCOVA|Sensitivity analysis using complete cases|Sensitivity analysis using complete cases|The analysis type was superiority between groups. In total 141 subjects were included|
1656611|NCT01600014|3048920|Superiority or Other||Mean Difference (Net)|-0.88|||<|0.001|2-Sided|95.0|-1.38|-0.38||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|ANCOVA|Analysed using ANCOVA adjusted for anatomical location, country and AK count at randomisation|Using baseline observation carried forward (BOCF) as the imputation method.|The analysis type was superiority between groups. In total 141 subjects were included|
1656612|NCT01600014|3048921|Superiority or Other||Percent cleared subjects|50.0|||||2-Sided|95.0|44.0|56.1|||||Estimation based on completers only.|Subjects randomised to vehicle were not included in the estimate of the overall clearance rate for the repeat-use regimen, from last treatment throught to Month 12. Instead, the subjects randomised to ingenol mebutate were given higher weights to reflect the hypothetical scenario where all randomised subjects were given active treatment during the repeat use cycle|
1656613|NCT01600014|3048921|Superiority or Other||Risk Ratio (RR)|2.24||||0.1|2-Sided|95.0|0.78|6.47||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 62 subjects were included|
1656614|NCT01600014|3048921|Superiority or Other||Risk Ratio (RR)|4.41||||0.016|2-Sided|95.0|1.1|17.62||A closed test procedure was chosen where the evaluation process stopped when the first non-significant results were observed thus securing that the overall significance level did not exceed 5% for multiple testing|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 141 subjects were included|
1656615|NCT01600014|3048922|Superiority or Other||Risk Ratio (RR)|2.37||||0.013|2-Sided|95.0|1.07|5.25||Chi-square test for stratified data with a significance level of 5%. No adjustment for multiple tests was needed, due to the analyses were based on distinct subject groups|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and week of randomisation||The analysis type was superiority between groups. In total 62 subjects were included|
1656616|NCT01600014|3048922|Superiority or Other||Risk Ratio (RR)|2.44||||0.001|2-Sided|95.0|1.32|4.51||Chi-square test for stratified data with a significance level of 5%. No adjustment for multiple tests was needed, due to the analyses were based on distinct subject groups|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel ratio of clearance rates (Ingenol mebutate relative to Vehicle) adjusted for anatomical location and country||The analysis type was superiority between groups. In total 141 subjects were included|
1656617|NCT01599832|3048923|Other|||||||0.083||||||P-value was from test of significance of log-transformed baseline K^trans.|Regression, Cox|Multivariate model with adjustment for prior treatment, and clinical prognostic index (good/intermediate/poor) (n=16 had complete data)|||
1656618|NCT01599806|3048958|Superiority or Other|||||||0.155|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.|
1656619|NCT01599806|3048959|Superiority or Other|||||||0.08|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.|
1656620|NCT01599806|3048960|Superiority or Other|||||||0.129|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.|
1656621|NCT01599806|3048961|Superiority or Other|||||||0.038|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.|
1656622|NCT01599806|3048962|Superiority or Other||Diff of favorable response rates|7.5|||||2-Sided|95.0|-9.91|24.01||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1656623|NCT01599806|3048963|Superiority or Other||Diff of favorable response rates|8.0|||||2-Sided|95.0|-10.03|25.21||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1656624|NCT01599806|3048964|Superiority or Other||Diff of favorable response rates|2.0|||||2-Sided|95.0|-13.18|16.89||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1656625|NCT01599806|3048965|Superiority or Other||Diff of clin cure rates in All patients|1.2|||||2-Sided|95.0|-7.5|9.2||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen|
1656626|NCT01599806|3048966|Superiority or Other||Diff of clin cure rates in All patients|1.4|||||2-Sided|95.0|-7.8|10.2||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen|
1656627|NCT01599806|3048967|Superiority or Other||Diff of clin cure rates in All patients|0.0|||||2-Sided|95.0|-10.4|10.1||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen|
1656628|NCT01599806|3048968|Superiority or Other||Diff of clinical cure rates|4.0|||||2-Sided|95.0|-1.0|9.05||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1656629|NCT01599806|3048969|Superiority or Other||Diff of clinical cure rates|3.7|||||2-Sided|95.0|0.41|7.16||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1656630|NCT01599806|3048970|Superiority or Other||Diff of clinical cure rates|-0.1|||||2-Sided|95.0|-1.99|1.61||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1656631|NCT01599806|3048971|Superiority or Other||Diff of clinical cure rates|2.0|||||2-Sided|95.0|-2.94|6.91||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1656632|NCT01599806|3048972|Superiority or Other||Diff of clinical cure rates|1.1|||||2-Sided|95.0|-2.07|4.32||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1656633|NCT01599806|3048973|Superiority or Other||Diff of clinical cure rates|-1.9|||||2-Sided|95.0|-4.3|0.04||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1656634|NCT01599806|3048974|Superiority or Other||Diff of clinical cure rates|2.2|||||2-Sided|95.0|-2.9|7.24||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1656635|NCT01599806|3048975|Superiority or Other||Diff of clinical cure rates|1.2|||||2-Sided|95.0|-2.03|4.56||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1656636|NCT01599806|3048976|Superiority or Other||Diff of clinical cure rates|-1.3|||||2-Sided|95.0|-3.64|0.55||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1656637|NCT01599806|3048977|Superiority or Other||Diff of clinical cure rates|1.3|||||2-Sided|95.0|-3.71|6.3||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1656638|NCT01599806|3048978|Superiority or Other||Diff of clinical cure rates|-0.1|||||2-Sided|95.0|-4.23|4.03||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1656639|NCT01599806|3048979|Superiority or Other||Diff of clinical cure rates|-1.4|||||2-Sided|95.0|-4.07|1.02||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1656640|NCT01599806|3048980|Superiority or Other||Diff of favorable response rates|9.7|||||2-Sided|95.0|1.72|17.55||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1656641|NCT01599806|3048981|Superiority or Other||Diff of favorable response rates|7.3|||||2-Sided|95.0|0.88|13.74||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1656642|NCT01599806|3048982|Superiority or Other||Diff of favorable response rates|0.2|||||2-Sided|95.0|-1.17|1.68||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1656643|NCT01599806|3048983|Superiority or Other||Diff of favorable response rates|10.9|||||2-Sided|95.0|2.86|18.85||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1656644|NCT01599806|3048984|Superiority or Other||Diff of favorable response rates|8.8|||||2-Sided|95.0|2.27|15.24||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1656645|NCT01599806|3048985|Superiority or Other||Diff of favorable response rates|0.2|||||2-Sided|95.0|-1.21|1.72||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1656646|NCT01599806|3048986|Superiority or Other||Diff of favorable response rates|7.3|||||2-Sided|95.0|0.68|13.81||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1656647|NCT01599806|3048987|Superiority or Other||Diff of favorable response rates|0.4|||||2-Sided|95.0|-2.7|3.56||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1656648|NCT01599806|3048988|Non-Inferiority or Equivalence|-12.5%|Diff of favorable response rates|6.4|||||2-Sided|95.0|0.33|12.36||||||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates ≤ non-inferiority margin|
1656649|NCT01599806|3048989|Non-Inferiority or Equivalence|-12.5%|Diff of favorable combined resp rates|6.7|||||2-Sided|95.0|0.3|13.12||||||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable combined response rates ≤ non-inferiority margin|
1656650|NCT01599806|3048990|Non-Inferiority or Equivalence|-12.5%|Difference of symp resolution rates|4.0|||||2-Sided|95.0|-2.39|10.42||||||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin|
1656651|NCT01599793|3048991|Other|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the Change in pain scale. We tested if the coefficient = 0|Spearman Correlation Coefficients|0.17669||||0.5828|2-Sided||||||t-test, 2 sided||||
1656652|NCT01599793|3048993|Other|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the PSA change. We tested if the coefficient = 0|Spearman Correlation Coefficients|-0.41818||||0.2006|2-Sided||||||t-test, 2 sided||||
1657011|NCT01597245|3049340|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1656653|NCT01599793|3048995|Other|We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the bone scan response change. We tested if the coefficient = 0|Spearman Correlation Coefficients|0.36853||||0.3291|2-Sided||||||t-test, 2 sided||||
1656654|NCT01599793|3048997|Equivalence|Testing if the change of ktrans between 2 weeks and baseline = 0 (i.e testing if the difference of means between 2 weeks and baseline =0)||||||0.0016|||||||Mixed Models Analysis|||The least square means of ktrans at different time points (baseline, 2 weeks, 12 weeks, 24 weeks) are estimated by a linear mixed model. Comparison of means at different time points were performed. The primary result reported below is for the difference of means between 2 weeks and baseline.|
1656655|NCT01599754|3049005|Superiority||Hazard Ratio (HR)|1.026||||0.9246|2-Sided|95.0|0.6|1.756|||Log Rank||||
1656656|NCT01599754|3049006|Superiority||Hazard Ratio (HR)|0.87||||0.3211|2-Sided|95.0|0.66|1.147|||Log Rank||||
1656657|NCT01599650|3049020|Superiority or Other||difference in LS Means|8.7|Standard Error of the Mean|1.46|<|0.0001|2-Sided|95.0|5.8|11.6|||ANOVA||||
1656658|NCT01599650|3049020|Superiority or Other||difference in LS mean|10.0|Standard Error of the Mean|1.41|<|0.0001|2-Sided|95.0|7.3|12.8|||ANOVA||||
1656659|NCT01599585|3049046|Non-Inferiority or Equivalence|One tailed test at .05a = .05 margin was set at standardized difference of .50|Regression, Beta|0.47|||||2-Sided|90.0|0.16|0.78|||||||
1656660|NCT01599585|3049058|Non-Inferiority or Equivalence|One tailed test at .05a = .05 margin was set at standardized difference of .50|Regression, Beta|0.4|||||2-Sided|90.0|0.12|0.68|||||||
1656661|NCT01599234|3049077|Superiority or Other||Odds Ratio (OR)|1.215||||0.569|2-Sided|95.0|0.622|2.373|||ANCOVA|||The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.|
1656662|NCT01599234|3049078|Superiority or Other||Estimated mean treatment difference|-0.15||||0.867|2-Sided|95.0|-1.95|1.64|||ANCOVA|||The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.|
1656663|NCT01599234|3049079|Superiority or Other||Odds Ratio (OR)|1.248||||0.27|2-Sided|95.0|0.842|1.849|||Regression, Logistic|||The two treatment groups were to be compared using ordinal logistic regression and the proportional odds model. The model was to incorporate ambulatory status at baseline and centre group.|
1656664|NCT01599234|3049080|Superiority or Other||Estimated mean treatment difference|0.0||||0.624|2-Sided|95.0|-2.0|1.0|||ANCOVA|||The change at end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.|
1656665|NCT01599234|3049082|Superiority or Other||Estimated mean treatment difference|-0.07||||0.734|2-Sided|95.0|-0.55|0.4|||ANCOVA|||The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.|
1656666|NCT01599234|3049083|Superiority or Other||Estimated mean treatment difference|-0.16||||0.857|2-Sided|95.0|-1.94|1.61|||ANCOVA|||The change at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment, centre group and ambulatory status at baseline as factors and baseline score as a covariate.|
1656667|NCT01599234|3049084|Superiority or Other||Odds Ratio (OR)|1.341||||0.231|2-Sided|95.0|0.83|2.167|||ANCOVA|||The numbers of responders was analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio. The two groups were compared using ANCOVA with baseline severity as a covariate and study centre and treatment group as factors.|
1656668|NCT01599234|3049085|Superiority or Other||Estimated mean treatment difference|-0.23||||0.22||95.0|-0.59|0.14|||ANCOVA|||The initial model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline as a covariate and treatment group, centre group, ambulatory status at baseline and previous use of cannabis as main effects. Interactions between the main effects were investigated, and if they had little influence then they were dropped from the model. These tests were performed at the 10% significance level as a possible indicator of an interactive effect.|
1656669|NCT01598831|3049113|Superiority||Risk Difference (RD)|-2.55||||0.318|2-Sided|95.0|-3.68|8.77||The threshold for statistical significance was a two sided 5%|Cochran-Mantel-Haenszel|CMH test controlled for the stratification factor.|Rates by Arm are 26.8% for ART-123 and 29.4% for Placebo||In a post hoc sensitivity analysis for the primary outcome that accounted for pooled site as a random effect, the adjusted 28-day all-cause mortality rate was 24.8%in the rhsTM group vs 27.5%in the placebo group (P = .31).
1656670|NCT01598740|3049116|Superiority or Other|||||||0.1899|||||||ANCOVA|||One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.|
1656671|NCT01598740|3049117|Superiority or Other|||||||0.0662|||||||ANCOVA|||One-way analysis of covariance (ANCOVA) common slopes model for a 2-period crossover design.|
1656672|NCT01598532|3049137|Superiority or Other||||||<|0.006|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effects of LED treatments|
1656673|NCT01598532|3049138|Superiority or Other||||||<|0.003|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for effect of LED treatments|
1656674|NCT01598532|3049139|Superiority or Other||||||<|0.003|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effect of LED treatments|
1656675|NCT01598532|3049140|Superiority or Other||||||<|0.004|||||||ANOVA|Univariate, one-way, repeated measure ANOVA with trend analysis||linear trend over time for the effect of LED treatments|
1656676|NCT01598311|3049149|Superiority|Superiority was declared if the lower bound of the 95% CI of the adjusted difference in sustained response was > 0.|Mean Difference (Final Values)|4.3|||||2-Sided|95.0|-3.6|12.2|||||||
1656677|NCT01598311|3049151|Non-Inferiority|Non-inferiority was declared when the lower bound of the 95% CI for the difference in adjusted percentage of cured subjects was > -10%.|Mean Difference (Final Values)|1.4|||||2-Sided|95.0|-4.9|7.6|||||||
1656703|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.68||||0.8159|2-Sided|95.0|0.291|1.623|||Bayesian repeated measures model|||Renin, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656678|NCT01598298|3049152|Other|Two-sided test at the alpha=0.05 level|Coefficient fro treatment term|-0.95|||<|0.0001|2-Sided|95.0|-1.35|-0.55||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for baseline pain interference score and the protocol-specified stratification factors (baseline average pain and prior taxane use).|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of pain interference scores at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline pain interference score and the stratification factors.|
1656679|NCT01598298|3049153|Other|Two-sided test at the alpha=0.05 level|Coefficient for treatment term|-1.06|||<|0.0001|2-Sided|95.0|-1.57|-0.55||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for baseline worst pain score and the protocol-specified stratification factors (baseline average pain and prior taxane use).|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for baseline worst pain score and the stratification factors.|
1656680|NCT01598298|3049154|Other|Two-sided test at the alpha=0.05 level|Coefficient for treatment term|-0.82||||0.0002|2-Sided|95.0|-1.24|-0.4||Two-sided p-value; alpha=0.05|Mixed Models Analysis|Adjusted for the protocol-specified stratification factors (baseline average pain and prior taxane use)|The estimation parameter is the model-based coefficient for the treatment term, with placebo as the reference level.|The primary analysis will rely on longitudinal measures of BPI at Weeks 2, 6, and 12 for improved power. Assessment windows of +/- 7 days, +/- 14 days, and +/- 14 days will be allowed for the 2, 6, and 12 week timepoints. The analysis will be performed using mixed models, adjusted for the stratification factors.|
1656681|NCT01598090|3049182|Non-Inferiority|Non-inferiority of Lambda/RBV/TVR to Alfa/RBV/TVR was not established because the lower limit of the 95% CI was less than the predefined non-inferiority margin of -12%. As a result, key secondary endpoints were not tested hierarchically to compare treatment groups.||||||0.0855||||||Non-inferiority testing is based on lower limit of confidence interval.|Mantel Haenszel||||
1656682|NCT01598064|3049185|Superiority or Other|||||||0.25|||||||Chi-squared||||
1656683|NCT01597908|3049189|Superiority or Other||Difference in percentage of responders|13.0||||0.0005|2-Sided|95.0|5.7|20.2|||Chi-squared||The difference in the percentage of participants (dabrafenib plus trametinib minus vemurafenib) with CR + PR was reported.||
1656684|NCT01597908|3049190|Superiority or Other||Hazard Ratio (HR)|0.56|||<|0.001|2-Sided|95.0|0.46|0.69|||Stratified log-rank test|Stratification was by Baseline LDH and BRAF mutation status.|Hazard ratios are estimated using a Pike estimator.||
1656685|NCT01597908|3049191|Superiority or Other||Hazard Ratio (HR)|0.69||||0.005|2-Sided|95.0|0.53|0.89|||Stratified log-rank test|Stratification was by Baseline LDH and BRAF mutation status.|Hazard ratios are estimated using a Pike estimator.||
1656686|NCT01597791|3049196|Superiority|||||||0.05||||||Calculated.|Fisher Exact||||
1656687|NCT01597635|3049222|Superiority or Other||Ratio of Active/Placebo|1.52||||0.9312|2-Sided|95.0|0.867|2.737|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours|
1656688|NCT01597635|3049222|Superiority or Other||Ratio of Active/Placebo|1.65||||0.983|2-Sided|95.0|1.045|2.588|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656689|NCT01597635|3049222|Superiority or Other||Ratio of Active/Placebo|1.61||||0.9954|2-Sided|95.0|1.13|2.331|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656690|NCT01597635|3049222|Superiority or Other||Ratio of Active/Placebo|1.27||||0.9973|2-Sided|95.0|1.005|1.606|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656691|NCT01597635|3049222|Superiority or Other||Ratio of Active/Placebo|1.26||||0.9907|2-Sided|95.0|1.042|1.526|||Bayesian repeated measures model|||SP-D, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656692|NCT01597635|3049222|Superiority or Other||Ratio of Active/Placebo|0.81||||0.9078|2-Sided|95.0|0.582|1.112|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours|
1656693|NCT01597635|3049222|Superiority or Other||Ratio of Active/Placebo|0.99||||0.5304|2-Sided|95.0|0.744|1.315|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656694|NCT01597635|3049222|Superiority or Other||Ratio of Active/Placebo|1.12||||0.6682|2-Sided|95.0|0.673|1.865|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656695|NCT01597635|3049222|Superiority or Other||Ratio of Active/Placebo|1.01||||0.5205|2-Sided|95.0|0.782|1.317|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656696|NCT01597635|3049222|Superiority or Other||Ratio of Active/Placebo|0.92||||0.7934|2-Sided|95.0|0.737|1.14|||Bayesian repeated measures model|||CCP-16, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656697|NCT01597635|3049223|Superiority or Other||Ratio of Active/Placebo|1.29||||0.6921|2-Sided|95.0|0.456|3.632|||Ratio of Active/Placebo|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656698|NCT01597635|3049223|Superiority or Other||Ratio of Active/Placebo|0.9||||0.6058|2-Sided|95.0|0.413|1.963|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656699|NCT01597635|3049223|Superiority or Other||Ratio of Active/Placebo|1.23||||0.7859|2-Sided|95.0|0.723|2.066|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656700|NCT01597635|3049223|Superiority or Other||Ratio of Active/Placebo|1.3||||0.9066|2-Sided|95.0|0.876|1.955|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656701|NCT01597635|3049223|Superiority or Other||Ratio of Active/Placebo|1.12||||0.6536|2-Sided|95.0|0.626|2.024|||Bayesian repeated measures model|||CRP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656702|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.53||||0.7988|2-Sided|95.0|0.106|2.657|||Bayesian repeated measures model|||Aldosterone, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656704|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.94||||0.61|2-Sided|95.0|0.588|1.509|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours|
1656705|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.88||||0.7668|2-Sided|95.0|0.612|1.26|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656706|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.95||||0.6267|2-Sided|95.0|0.679|1.333|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656707|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.98||||0.5446|2-Sided|95.0|0.723|1.33|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656708|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.83||||0.8835|2-Sided|95.0|0.609|1.135|||Bayesian repeated measures model|||Angiopoietin-2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656709|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|1.48||||0.8676|2-Sided|95.0|0.73|3.064|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours|
1656710|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|1.43||||0.9217|2-Sided|95.0|0.866|2.382|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656711|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|1.26||||0.9118|2-Sided|95.0|0.896|1.771|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656712|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|1.25||||0.9375|2-Sided|95.0|0.937|1.683|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656713|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|1.09||||0.74|2-Sided|95.0|0.828|1.448|||Bayesian repeated measures model|||MPO, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656714|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|1.03||||0.5291|2-Sided|95.0|0.483|2.118|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours|
1656715|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.91||||0.6183|2-Sided|95.0|0.454|1.742|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656716|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.98||||0.5264|2-Sided|95.0|0.541|1.788|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656717|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|1.0||||0.4955|2-Sided|95.0|0.703|1.415|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656718|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.92||||0.7338|2-Sided|95.0|0.714|1.197|||Bayesian repeated measures model|||RAGE, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656719|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.47||||0.8787|2-Sided|95.0|0.112|1.69|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours|
1656720|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.72||||0.7088|2-Sided|95.0|0.216|2.419|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656721|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.51||||0.9254|2-Sided|95.0|0.203|1.289|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656722|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.73||||0.7696|2-Sided|95.0|0.3|1.731|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656723|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.99||||0.513|2-Sided|95.0|0.549|1.721|||Bayesian repeated measures model|||IL-6, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656724|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|1.17||||0.699|2-Sided|95.0|0.622|2.155|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours|
1656725|NCT01597635|3049224|Superiority||Ratio of Active/Placebo|0.97||||0.5358|2-Sided|95.0|0.531|1.76|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656726|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.66||||0.8855|2-Sided|95.0|0.321|1.316|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656727|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.96||||0.5674|2-Sided|95.0|0.57|1.609|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656728|NCT01597635|3049224|Superiority or Other||Ratio of Active/Placebo|0.88||||0.06828|2-Sided|95.0|0.528|1.501|||Bayesian repeated measures model|||CXCL-8 (IL-8), Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656729|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.05||||0.5915|2-Sided|95.0|0.748|1.516|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours|
1656730|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|0.92||||0.39|2-Sided|95.0|0.521|1.584|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656731|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|0.77||||0.1574|2-Sided|95.0|0.488|1.39|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours|
1656732|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.13||||0.6768|2-Sided|95.0|0.672|1.853|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours|
1656733|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|0.9||||0.3586|2-Sided|95.0|0.568|1.458|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours|
1656734|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.02||||0.5284|2-Sided|95.0|0.614|1.663|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours|
1656994|NCT01597245|3049334|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1656735|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|0.94||||0.4079|2-Sided|95.0|0.609|1.51|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours|
1656736|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|0.88||||0.286|2-Sided|95.0|0.587|1.348|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours|
1656737|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|0.83||||0.2211|2-Sided|95.0|0.555|1.317|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours|
1656738|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|0.92||||0.3606|2-Sided|95.0|0.61|1.467|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours|
1656739|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|0.87||||0.2773|2-Sided|95.0|0.566|1.38|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656740|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.09||||0.6565|2-Sided|95.0|0.686|1.714|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours|
1656741|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.17||||0.7748|2-Sided|95.0|0.752|1.77|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours|
1656742|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.06||||0.6158|2-Sided|95.0|0.719|1.639|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours|
1656743|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|0.98||||0.4546|2-Sided|95.0|0.661|1.512|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours|
1656744|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.05||||0.5828|2-Sided|95.0|0.687|1.63|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours|
1656745|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|0.91||||0.325|2-Sided|95.0|0.626|1.416|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours|
1656746|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.18||||0.8032|2-Sided|95.0|0.83|1.814|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours|
1656747|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.06||||0.6291|2-Sided|95.0|0.763|1.647|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours|
1656748|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|0.99||||0.4739|2-Sided|95.0|0.713|1.527|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656749|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.25||||0.8349|2-Sided|95.0|0.812|2.05|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours|
1656750|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.17||||0.7566|2-Sided|95.0|0.737|1.958|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656751|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.2||||0.7905|2-Sided|95.0|0.776|1.799|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours|
1656752|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.23||||0.8008|2-Sided|95.0|0.775|1.832|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours|
1656753|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.26||||0.8292|2-Sided|95.0|0.81|1.949|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours|
1656754|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.12||||0.7173|2-Sided|95.0|0.749|1.621|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours|
1656755|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.35||||0.9441|2-Sided|95.0|0.931|2.068|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour|
1656756|NCT01597635|3049227|Superiority or Other||Ratio of Active/Placebo|1.06||||0.6098|2-Sided|95.0|0.721|1.644|||Bayesian repeated measures model|||Oxygenation index, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours|
1656757|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.85||||0.1095|2-Sided|95.0|0.615|1.073|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours|
1656758|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|1.02||||0.5567|2-Sided|95.0|0.766|1.358|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656759|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|1.05||||0.6494|2-Sided|95.0|0.787|1.377|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours|
1656760|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.95||||0.3499|2-Sided|95.0|0.73|1.225|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours|
1656761|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.96||||0.3623|2-Sided|95.0|0.74|1.24|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours|
1656762|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.9||||0.2102|2-Sided|95.0|0.687|1.159|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours|
1656763|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.92||||0.2659|2-Sided|95.0|0.703|1.199|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours|
1656764|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.99||||0.4797|2-Sided|95.0|0.754|1.315|||Ratio of Active/Placebo|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours|
1656765|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|1.05||||0.6418|2-Sided|95.0|0.798|1.411|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours|
1656766|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.9||||0.2129|2-Sided|95.0|0.689|1.183|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours|
1656767|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|1.05||||0.634|2-Sided|95.0|0.811|1.368|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656768|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.99||||0.47|2-Sided|95.0|0.775|1.279|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours|
1656769|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.8||||0.0512|2-Sided|95.0|0.612|1.05|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours|
1656770|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.89||||0.1951|2-Sided|95.0|0.678|1.161|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours|
1656771|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|1.0||||0.4947|2-Sided|95.0|0.759|1.301|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours|
1656772|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.88||||0.1493|2-Sided|95.0|0.684|1.12|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours|
1656773|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|1.0||||0.5033|2-Sided|95.0|0.78|1.27|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours|
1656774|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.93||||0.2866|2-Sided|95.0|0.726|1.19|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours|
1656775|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.93||||0.2716|2-Sided|95.0|0.733|1.2|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours|
1656776|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.91||||0.2232|2-Sided|95.0|0.722|1.195|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656777|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.98||||0.435|2-Sided|95.0|0.765|1.253|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours|
1656778|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|1.04||||0.6093|2-Sided|95.0|0.8|1.325|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656779|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|1.06||||0.6855|2-Sided|95.0|0.842|1.345|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours|
1656780|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.9||||0.2011|2-Sided|95.0|0.715|1.159|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours|
1656781|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.85||||0.0877|2-Sided|95.0|0.669|1.075|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours|
1656782|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.9||||0.1681|2-Sided|95.0|0.694|1.129|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours|
1656783|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|0.9||||0.1965|2-Sided|95.0|0.658|1.136|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour|
1656784|NCT01597635|3049228|Superiority or Other||Ratio of Active/Placebo|1.05||||0.6468|2-Sided|95.0|0.765|1.321|||Bayesian repeated measures model|||PaO2/FiO2, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours|
1656785|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.14||||0.8145|2-Sided|95.0|0.804|1.505|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours|
1656786|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.16||||0.8817|2-Sided|95.0|0.907|1.502|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656787|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.96||||0.4003|2-Sided|95.0|0.743|1.241|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours|
1656788|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.04||||0.638|2-Sided|95.0|0.845|1.292|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours|
1656789|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.96||||0.3524|2-Sided|95.0|0.783|1.178|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours|
1656790|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.0||||0.5156|2-Sided|95.0|0.805|1.23|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours|
1656791|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.06||||0.7012|2-Sided|95.0|0.847|1.302|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours|
1656792|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.13||||0.8677|2-Sided|95.0|0.922|1.4|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours|
1656793|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.08||||0.7607|2-Sided|95.0|0.885|1.353|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours|
1656794|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.09||||0.7886|2-Sided|95.0|0.891|1.348|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours|
1656795|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.98||||0.4143|2-Sided|95.0|0.795|1.208|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656995|NCT01597245|3049335|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1656996|NCT01597245|3049335|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1656796|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.94||||0.2709|2-Sided|95.0|0.769|1.135|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours|
1656797|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.01||||0.5558|2-Sided|95.0|0.84|1.218|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours|
1656798|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.0||||0.503|2-Sided|95.0|0.843|1.201|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours|
1656799|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.01||||0.5552|2-Sided|95.0|0.848|1.22|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours|
1656800|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.01||||0.5627|2-Sided|95.0|0.856|1.217|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours|
1656801|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.99||||0.4754|2-Sided|95.0|0.837|1.181|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours|
1656802|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.91||||0.1281|2-Sided|95.0|0.77|1.065|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours|
1656803|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.98||||0.387|2-Sided|95.0|0.824|1.132|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours|
1656804|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.0||||0.5186|2-Sided|95.0|0.844|1.169|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656805|NCT01597635|3049229|Superiority or Other||0.0406|0.85||||0.0406|2-Sided|95.0|0.703|1.021|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours|
1656806|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.0||||0.4823|2-Sided|95.0|0.83|1.187|||Mixed Models Analysis|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656807|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.85||||0.0209|2-Sided|95.0|0.716|0.993|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours|
1656808|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.02||||0.5795|2-Sided|95.0|0.856|1.197|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours|
1656809|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.03||||0.6131|2-Sided|95.0|0.856|1.212|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours|
1656810|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.04||||0.6658|2-Sided|95.0|0.869|1.223|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours|
1656811|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.0||||0.4806|2-Sided|95.0|0.843|1.166|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour|
1656812|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.08||||0.8024|2-Sided|95.0|0.91|1.261|||Bayesian repeated measures model|||Plateau ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours|
1656813|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.26||||0.983|2-Sided|95.0|1.019|1.444|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours|
1656814|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.28||||0.9946|2-Sided|95.0|1.059|1.514|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656815|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.07||||0.7911|2-Sided|95.0|0.902|1.256|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours|
1656816|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.11||||0.9232|2-Sided|95.0|0.958|1.278|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours|
1656817|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.09||||0.8802|2-Sided|95.0|0.943|1.261|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours|
1656818|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.08||||0.8595|2-Sided|95.0|0.942|1.243|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours|
1656819|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.01||||0.53|2-Sided|95.0|0.871|1.164|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours|
1656820|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.13||||0.9504|2-Sided|95.0|0.976|1.3|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours|
1656821|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.06||||0.8084|2-Sided|95.0|0.924|1.228|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours|
1656822|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.08||||0.8661|2-Sided|95.0|0.941|1.246|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours|
1656823|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.04||||0.7027|2-Sided|95.0|0.906|1.197|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656824|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.98||||0.3594|2-Sided|95.0|0.853|1.112|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours|
1656997|NCT01597245|3049335|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1656825|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.88||||0.0274||95.0|0.763|1.003|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours|
1656826|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.91||||0.0762|2-Sided|95.0|0.803|1.035|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours|
1656827|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.97||||0.3152|2-Sided|95.0|0.85|1.101|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours|
1656828|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.92||||0.1026|2-Sided|95.0|0.801|1.047|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours|
1656829|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.99||||0.4631|2-Sided|95.0|0.87|1.134|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours|
1656830|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.93||||0.1245|2-Sided|95.0|0.812|1.056|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours|
1656831|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.97||||0.3231|2-Sided|95.0|0.849|1.103|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours|
1656832|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.98||||0.398|2-Sided|95.0|0.859|1.118|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656833|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.98||||0.3759|2-Sided|95.0|0.863|1.115|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours|
1656834|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.04||||0.7445|2-Sided|95.0|0.918|1.19|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656835|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.04||||0.7108|2-Sided|95.0|0.906|1.179|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours|
1656836|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.05||||0.7532|2-Sided|95.0|0.918|1.18|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours|
1656837|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.01||||0.5886|2-Sided|95.0|0.887|1.152|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours|
1656838|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.07||||0.8374|2-Sided|95.0|0.932|1.224|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hour|
1656839|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.07||||0.8558|2-Sided|95.0|0.94|1.23|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour|
1656840|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.02||||0.5885|2-Sided|95.0|0.89|1.164|||Bayesian repeated measures model|||Peak ventilatory pressure, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours|
1656841|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.09||||0.8522|2-Sided|95.0|0.916|1.234|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 168 hours|
1656842|NCT01597635|3049229|Superiority||Ratio of Active/Placebo|0.92||||0.2294|2-Sided|95.0|0.749|1.146|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656843|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.96||||0.3887|2-Sided|95.0|0.767|1.222|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours|
1656844|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.92||||0.2476|2-Sided|95.0|0.727|1.16|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours|
1656845|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.94||||0.3101|2-Sided|95.0|0.737|1.17|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 56 hours|
1656846|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.93||||0.2585|2-Sided|95.0|0.727|1.157|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours|
1656847|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.92||||0.2471|2-Sided|95.0|0.721|1.151|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 52 hours|
1656848|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.91||||0.2406|2-Sided|95.0|0.717|1.143|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours|
1656849|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.9||||0.2173|2-Sided|95.0|0.708|1.127|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 49 hours|
1656850|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.92||||0.2575|2-Sided|95.0|0.721|1.149|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours|
1656851|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.91||||0.2373|2-Sided|95.0|0.72|1.142|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656852|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.93||||0.2663|2-Sided|95.0|0.731|1.132|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 42 hours|
1656853|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.98||||0.4213|2-Sided|95.0|0.783|1.2|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 36 hours|
1656854|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.0||||0.5114|2-Sided|95.0|0.817|1.246|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 32 hours|
1656855|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.97||||0.4104|2-Sided|95.0|0.786|1.204|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 30 hours|
1656856|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|1.02||||0.5748|2-Sided|95.0|0.828|1.247|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 28 hours|
1656857|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.99||||0.4662|2-Sided|95.0|0.814|1.21|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 26 hours|
1656858|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.88||||0.1219|2-Sided|95.0|0.725|1.073|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 25 hours|
1656859|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.96||||0.3584|2-Sided|95.0|0.788|1.168|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24.5 hours|
1656860|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.96||||0.3608|2-Sided|95.0|0.786|1.166|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656861|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.95||||0.3339|2-Sided|95.0|0.77|1.163|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 18 hours|
1656862|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.96||||0.3365|2-Sided|95.0|0.79|1.167|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656863|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.99||||0.4578|2-Sided|95.0|0.818|1.229|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 8 hours|
1656864|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.99||||0.4432|2-Sided|95.0|0.811|1.262|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours|
1656865|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.98||||0.442|2-Sided|95.0|0.806|1.292|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 4 hours|
1656866|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.98||||0.4175|2-Sided|95.0|0.791|1.294|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours|
1656867|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.97||||0.3949|2-Sided|95.0|0.783|1.273|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 1 hour|
1656868|NCT01597635|3049229|Superiority or Other||Ratio of Active/Placebo|0.93||||0.2598|2-Sided|95.0|0.752|1.215|||Bayesian repeated measures model|||PEEP, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours|
1656869|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.38||||0.9375|2-Sided|95.0|0.154|1.341|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours|
1656870|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.34||||0.9781|2-Sided|95.0|0.119|0.969|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours|
1656871|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.24||||0.9993|2-Sided|95.0|0.098|0.578|||Ratio of Active/Placebo|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656872|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.25||||0.9995|2-Sided|95.0|0.107|0.584|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours|
1656873|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.31||||0.9964|2-Sided|95.0|0.131|0.729|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours|
1656874|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.24||||0.9995|2-Sided|95.0|0.102|0.561|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours|
1656875|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.28||||0.9992|2-Sided|95.0|0.119|0.626|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours|
1656876|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.24||||0.9998|2-Sided|95.0|0.103|0.529|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours|
1656877|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.4||||0.9863|2-Sided|95.0|0.173|0.901|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656878|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.17||||0.9999|2-Sided|95.0|0.075|0.4|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656879|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.2||||0.9998|2-Sided|95.0|0.086|0.453|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656880|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.08||||1|2-Sided|95.0|0.034|0.177|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours|
1656881|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.1||||1|2-Sided|95.0|0.043|0.216|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours|
1656882|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.06||||1|2-Sided|95.0|0.028|0.14|||Bayesian repeated measures model|||Ang II/Ang1-7, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours|
1656883|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.79||||0.7085|2-Sided|95.0|0.324|1.847|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours|
1656884|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.82||||0.6621|2-Sided|95.0|0.319|2.136|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours|
1656885|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.26||||0.9996|2-Sided|95.0|0.119|0.57|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656886|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.22||||0.9999|2-Sided|95.0|0.105|0.468|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours|
1656887|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.34||||0.9977|2-Sided|95.0|0.162|0.73|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours|
1656888|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.31||||0.9985|2-Sided|95.0|0.141|0.666|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours|
1656889|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.25||||0.9998|2-Sided|95.0|0.119|0.539|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours|
1656890|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.19||||1||95.0|0.091|0.417|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours|
1656891|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.32||||0.9979|2-Sided|95.0|0.149|0.682|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656892|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.29||||0.9991|2-Sided|95.0|0.13|0.634|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656893|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.25||||0.9996|2-Sided|95.0|0.113|0.547|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656894|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.11||||1|2-Sided|95.0|0.054|0.243|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours|
1656895|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.1||||1|2-Sided|95.0|0.048|0.209|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours|
1656896|NCT01597635|3049230|Superiority or Other||Ratio of Active/Placebo|0.07||||1|2-Sided|95.0|0.032|0.14|||Bayesian repeated measures model|||Ang II/Ang1-5, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours|
1656897|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.38||||0.7714|2-Sided|95.0|0.651|3.321|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours|
1656898|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.38||||0.7339|2-Sided|95.0|0.49|3.915|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours|
1656899|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.76||||0.9038|2-Sided|95.0|0.741|4.17|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656900|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.17||||0.648|2-Sided|95.0|0.516|2.675|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours|
1656901|NCT01597635|3049231|Superiority||Ratio of Active/Placebo|1.32||||0.7483|2-Sided|95.0|0.584|3.007|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours|
1656902|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.81||||0.9275|2-Sided|95.0|0.816|4.005|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours|
1656903|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.91||||0.9549|2-Sided|95.0|0.862|4.173|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours|
1656904|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.99||||0.9566|2-Sided|95.0|0.899|4.342|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours|
1656905|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.59||||0.8749|2-Sided|95.0|0.711|3.473|||Mixed Models Analysis|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656906|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|2.19||||0.9649|2-Sided|95.0|0.94|4.975|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656907|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|2.25||||0.9713|2-Sided|95.0|0.972|5.136|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656908|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|5.26||||1|2-Sided|95.0|2.392|11.754|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours|
1656909|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|3.67||||0.9993|2-Sided|95.0|1.689|7.97|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours|
1656910|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|4.22||||0.9998|2-Sided|95.0|1.91|8.905|||Bayesian repeated measures model|||Ang1-7 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours|
1656911|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.63||||0.8982|2-Sided|95.0|0.351|1.257|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours|
1656912|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.57||||0.9324|2-Sided|95.0|0.276|1.183|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours|
1656913|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.45||||0.8951|2-Sided|95.0|0.814|2.604|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656914|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.24||||0.773|2-Sided|95.0|0.705|2.113|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours|
1656915|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.23||||0.7778|2-Sided|95.0|0.718|2.087|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours|
1656916|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.27||||0.7996|2-Sided|95.0|0.729|2.163|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours|
1656917|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.94||||0.99|2-Sided|95.0|1.112|3.359|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours|
1656918|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|2.29||||0.9983|2-Sided|95.0|1.316|3.974|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours|
1656998|NCT01597245|3049336|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1656919|NCT01597635|3049231|Superiority||Ratio of Active/Placebo|1.92||||0.9891|2-Sided|95.0|1.098|3.349|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656920|NCT01597635|3049231|Superiority||Ratio of Active/Placebo|1.5||||0.9129|2-Sided|95.0|0.828|2.636|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656921|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|1.82||||0.9806|2-Sided|95.0|1.031|3.17|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656922|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|3.59||||1|2-Sided|95.0|2.06|6.345|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours|
1656923|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|3.46||||1|2-Sided|95.0|1.976|6.052|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours|
1656924|NCT01597635|3049231|Superiority||Ratio of Active/Placebo|3.98||||1|2-Sided|95.0|2.263|6.919|||Bayesian repeated measures model|||Ang1-5 , Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours|
1656925|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.51||||0.9719|2-Sided|95.0|0.23|1.014|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 120 hours|
1656926|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.36||||0.9852|2-Sided|0.9852|0.137|0.906|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 96 hours|
1656927|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.29||||0.9991|2-Sided|95.0|0.13|0.647|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 72 hours|
1656928|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.25||||0.9999|2-Sided|95.0|0.114|0.532|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 66 hours|
1656929|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.34||||0.9964|2-Sided|95.0|0.157|0.747|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 60 hours|
1656930|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.33||||0.9956|2-Sided|95.0|0.151|0.759|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 54 hours|
1656931|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.38||||0.9875|2-Sided|95.0|0.179|0.891|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 50 hours|
1656932|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.33||||0.9941||95.0|0.157|0.789|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48.5 hours|
1656933|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.46||||0.9631|2-Sided|95.0|0.213|1.081|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 48 hours|
1656934|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.29||||0.9991|2-Sided|95.0|0.133|0.632|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 24 hours|
1656935|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.31||||0.9997|2-Sided|95.0|0.136|0.66|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 12 hours|
1656936|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.26||||0.9997|2-Sided|95.0|0.121|0.568|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 6 hours|
1656937|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.23||||0.9999|2-Sided|95.0|0.111|0.492|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 2 hours|
1656938|NCT01597635|3049231|Superiority or Other||Ratio of Active/Placebo|0.17||||1|2-Sided|95.0|0.083|0.359|||Bayesian repeated measures model|||AngII, Part B (Placebo BID) Vs Part B (GSK2586881 BID) at 0.5 hours|
1656939|NCT01597505|3049259|Superiority|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.|Difference in percentage of participants|4.3|||||2-Sided|95.0|-4.2|12.7|||||Treatment group proportions were stratified by age group (< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.|Difference in percentage of participants|
1656940|NCT01597505|3049260|Superiority|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.|Difference in percentage of participants|14.6|||||2-Sided|95.0|-2.7|30.7|||||Treatment group percentages were stratified by age group (< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.|Difference in percentage of participants|
1656941|NCT01597505|3049261|Superiority|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.|Difference in percentage of participants|-2.4|||||2-Sided|95.0|-7.8|3.0|||||Treatment group proportions were stratified by age group (< 75, ≥ 75) and number of previous CDAD episodes (0, ≥1). The 95% CIs were stratified Wilson intervals for the treatment group proportions.|Difference in percentage of participants|
1656942|NCT01597505|3049262|Superiority|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.|Difference in percentage of participants|2.2|||||2-Sided|95.0|-10.7|14.8|||||Treatment group percentages were stratified by age group (< 75, ≥ 75) and number of previous CDAD episodes (0, ≥ 1). The 95% CIs were stratified Wilson intervals for the treatment group percentages.|Difference in percentage of participants|
1656943|NCT01597505|3049263|Superiority|Surotomycin was superior to vancomycin if the p-value was less than 0.05||||||0.011||||||Log-rank test of equality of survival times, stratified by age group (< 75, >= 75 years) and number of CDAD episodes (0, >= 1). Significance cut-off = 0.05|Log Rank|||Stratified Log-Rank p-Value|
1656944|NCT01597505|3049264|Superiority|Surotomycin was superior to vancomycin if the p-value was less than 0.05||||||0.431||||||Log-rank test of equality of survival times, stratified by age group (< 75, >= 75 years) and number of CDAD episodes (0, >= 1). Significance cut-off = 0.05|Log Rank|||Stratified Log-Rank p-Value|
1656999|NCT01597245|3049336|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1657000|NCT01597245|3049337|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1656945|NCT01597505|3049265|Superiority|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.|Difference in percentage of participants|-3.5|||||2-Sided|95.0|-10.0|3.0|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants|
1656946|NCT01597505|3049266|Superiority|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.|Difference in percentage of participants|0.6|||||2-Sided|95.0|-7.2|8.3|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants|
1656947|NCT01597505|3049270|Superiority|Surotomycin - Vancomycin. For surotomycin to be considered superior to vancomycin the lower bound of the 2-sided 95% CI had to be > 0%.|Difference in percentage of participants|-0.8|||||2-Sided|95.0|-8.8|7.1|||||The 95% CI was stratified Wilson intervals for group percentages and a stratified Newcombe interval for the difference, using the MRc stratum weights. Stratified by age group and number of CDAD episodes.|Difference in percentage of participants|
1656948|NCT01597505|3049271|Superiority|||||||0.832||||||Log-rank test of equality of survival times, stratified by age group (< 75, >= 75 years) and number of CDAD episodes (0, >= 1). Significance cut-off = 0.05|Log Rank|||Stratified log-rank test p-value|
1656949|NCT01597505|3049272|Non-Inferiority|Surotomycin minus Vancomycin. For surotomycin to be non-inferior to vancomycin the lower bound of a 2-sided 95% CI for the difference between treatment groups had to be ≥ -10%.|Difference in percentage of participants|-4.6|||||2-Sided|95.0|-11.0|1.9|||||The 95% confidence interval (CI) were stratified Wilson intervals for the treatment group percentages and a stratified Newcombe interval for the treatment difference, constructed using the MRc stratum weights.|Difference in percentage of participants|
1656950|NCT01597245|3049326|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||PPASI 100|
1656951|NCT01597245|3049326|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||PPASI 100|
1656952|NCT01597245|3049326|Superiority or Other||||||<|0.002|||||||Cochran-Mantel-Haenszel|||PPASI 100|
1656953|NCT01597245|3049326|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||PPASI 75|
1656954|NCT01597245|3049326|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||PPASI 75|
1656955|NCT01597245|3049326|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||PPASI 75|
1656956|NCT01597245|3049326|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||PPASI 50|
1656957|NCT01597245|3049326|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||PPASI 50|
1656958|NCT01597245|3049326|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||PPASI 50|
1656959|NCT01597245|3049327|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1656960|NCT01597245|3049327|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1656961|NCT01597245|3049327|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1656962|NCT01597245|3049328|Superiority or Other||||||<|0.001|||||||ANCOVA|||Mental Summary Score|
1656963|NCT01597245|3049328|Superiority or Other||||||<|0.001|||||||ANCOVA|||Mental Summary Score|
1656964|NCT01597245|3049328|Superiority or Other||||||<|0.001|||||||ANCOVA|||Mental Summary Score|
1656965|NCT01597245|3049328|Superiority or Other||||||<|0.001|||||||ANCOVA|||Physical Summary Score|
1656966|NCT01597245|3049328|Superiority or Other||||||<|0.001|||||||ANCOVA|||Physical Summary Score|
1656967|NCT01597245|3049328|Superiority or Other||||||<|0.001|||||||ANCOVA|||Physical Summary Score|
1656968|NCT01597245|3049329|Superiority or Other||||||<|0.001|||||||ANCOVA|||Work Productivity Loss Score|
1656969|NCT01597245|3049329|Superiority or Other||||||<|0.001|||||||ANCOVA|||Work Productivity Loss Score|
1656970|NCT01597245|3049329|Superiority or Other||||||<|0.001|||||||ANCOVA|||Work Productivity Loss Score|
1656971|NCT01597245|3049329|Superiority or Other||||||<|0.001|||||||ANCOVA|||Presenteeism Score|
1656972|NCT01597245|3049329|Superiority or Other||||||<|0.001|||||||ANCOVA|||Presenteeism Score|
1656973|NCT01597245|3049329|Superiority or Other||||||<|0.001|||||||ANCOVA|||Presenteeism Score|
1656974|NCT01597245|3049329|Superiority or Other||||||<|0.001|||||||ANCOVA|||Activity Impairment Score|
1656975|NCT01597245|3049329|Superiority or Other||||||<|0.001|||||||ANCOVA|||Activity Impairment Score|
1656976|NCT01597245|3049329|Superiority or Other||||||<|0.001|||||||ANCOVA|||Activity Impairment Score|
1656977|NCT01597245|3049329|Superiority or Other||||||<|0.016|||||||ANCOVA|||Absenteeism Score|
1656978|NCT01597245|3049329|Superiority or Other||||||<|0.076|||||||ANCOVA|||Absenteeism Score|
1656979|NCT01597245|3049329|Superiority or Other||||||<|0.026|||||||ANCOVA|||Absenteeism Score|
1656980|NCT01597245|3049330|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1656981|NCT01597245|3049330|Superiority or Other||||||<|0.002|||||||ANCOVA||||
1656982|NCT01597245|3049330|Superiority or Other||||||<|0.15|||||||ANCOVA||||
1656983|NCT01597245|3049331|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1656984|NCT01597245|3049331|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1656985|NCT01597245|3049331|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1656986|NCT01597245|3049332|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1656987|NCT01597245|3049332|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1656988|NCT01597245|3049332|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1656989|NCT01597245|3049333|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1656990|NCT01597245|3049333|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1656991|NCT01597245|3049333|Superiority or Other||||||<|0.002|||||||Mixed Models Analysis||||
1656992|NCT01597245|3049334|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1656993|NCT01597245|3049334|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1657012|NCT01597245|3049341|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1657013|NCT01597245|3049341|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1657014|NCT01597245|3049341|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1657015|NCT01596582|3049398|Superiority|||||||0.39|||||||Fisher Exact||||
1657016|NCT01596582|3049399|Superiority|||||||1|||||||Fisher Exact||||
1657017|NCT01596582|3049400|Superiority|||||||0.62|||||||Fisher Exact||||
1657018|NCT01596582|3049401|Superiority|||||||0.51|||||||Chi-squared||||
1657019|NCT01596582|3049402|Superiority||||||>|0.05||||||The p-value for each comparison was non-significanct.|Wilcoxon (Mann-Whitney)||||
1657020|NCT01596582|3049403|Superiority|||||||0.004|||||||Chi-squared||||
1657021|NCT01596582|3049404|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1657022|NCT01596582|3049405|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1657023|NCT01596582|3049406|Superiority|||||||0.51|||||||Chi-squared||||
1657024|NCT01596582|3049407|Superiority|||||||0.4|||||||Chi-squared||||
1657025|NCT01596504|3049424|Superiority or Other||LS mean difference|-4.61|Standard Error of the Mean|1.04|<|0.0001|1-Sided|95.0|-6.34|||p-values ordered(p1≤p2) as per rules:if p2≤0.05:lixisenatide superior to liraglutide (both doses);if p2>0.05 & p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2>0.05 & p1>0.025: no comparison as statistically significant.|Linear fixed effects model|The threshold for significance at 0.05 level.|Lixisenatide vs Liraglutide 1. 8 mg|Analysis was performed using linear mixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 [<8% and >=8%], use of metformin at screening [yes or no]), and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.|
1657026|NCT01596504|3049424|Superiority or Other||Least squares (LS) mean difference|-6.01|Standard Error of the Mean|1.06|<|0.0001|1-Sided|95.0|-7.77|||p-values ordered(p1≤p2) as per rules:if p2≤0.05: lixisenatide superior to liraglutide (both doses);if p2>0.05 & p1≤0.025:lixisenatide superior to dose of liraglutide associated with p1;if p2>0.05 & p1>0.025:no comparison as statistically significant.|Linear fixed effects model|The threshold for significance at 0.05 level.|Lixisenatide vs Liraglutide 1.2 mg|Analysis was performed using linear fixed effects model with treatment groups and stratification factors (HbA1c levels on Day -7 [<8% and >=8%], use of metformin at screening [yes or no]) and the study site) as fixed effects and baseline plasma glucose AUC from 0.5 to 4.5 hours as covariate. To address multiplicity issue and ensure overall 1-sided level of 5%, Hochberg method was used for testing procedure of comparison between lixisenatide vs liraglutide 1.2 mg or 1.8 mg.|
1657027|NCT01595438|3049494|Superiority or Other|||||||0.155|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.|
1657028|NCT01595438|3049495|Superiority or Other|||||||0.08|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.|
1657029|NCT01595438|3049496|Superiority or Other|||||||0.129|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.|
1657030|NCT01595438|3049497|Superiority or Other|||||||0.038|||||||Log Rank|||H0: No difference in time to first defervescence between treatment groups.|
1657031|NCT01595438|3049498|Superiority or Other||Diff of favorable response rates|7.5|||||2-Sided|95.0|-9.91|24.01||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1657032|NCT01595438|3049499|Superiority or Other||Diff of favorable response rates|8.0|||||2-Sided|95.0|-10.03|25.21||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1657033|NCT01595438|3049500|Superiority or Other||Diff of favorable response rates|2.0|||||2-Sided|95.0|-13.18|16.89||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1657034|NCT01595438|3049501|Superiority or Other||Diff of clin cure rates in All patients|1.2|||||2-Sided|95.0|-7.5|9.2||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen|
1657035|NCT01595438|3049502|Superiority or Other||Diff of clin cure rates in All patients|1.4|||||2-Sided|95.0|-7.8|10.2||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen|
1657036|NCT01595438|3049503|Superiority or Other||Diff of clin cure rates in All patients|0.0|||||2-Sided|95.0|-10.4|10.1||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates in All patients with a ceftazidime-resistant Gram-negative pathogen|
1657037|NCT01595438|3049504|Superiority or Other||Diff of clinical cure rates|4.0|||||2-Sided|95.0|-1.0|9.05||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1657038|NCT01595438|3049505|Superiority or Other||Diff of clinical cure rates|3.7|||||2-Sided|95.0|0.41|7.16||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1657039|NCT01595438|3049506|Superiority or Other||Diff of clinical cure rates|-0.1|||||2-Sided|95.0|-1.99|1.61||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1657040|NCT01595438|3049507|Superiority or Other||Diff of clinical cure rates|2.0|||||2-Sided|95.0|-2.94|6.91||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1657041|NCT01595438|3049508|Superiority or Other||Diff of clinical cure rates|1.1|||||2-Sided|95.0|-2.07|4.32||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1657042|NCT01595438|3049509|Superiority or Other||Diff of clinical cure rates|-1.9|||||2-Sided|95.0|-4.3|0.04||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1657043|NCT01595438|3049510|Superiority or Other||Diff of clinical cure rates|2.2|||||2-Sided|95.0|-2.9|7.24||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1657044|NCT01595438|3049511|Superiority or Other||Diff of clinical cure rates|1.2|||||2-Sided|95.0|-2.03|4.56||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1657045|NCT01595438|3049512|Superiority or Other||Diff of clinical cure rates|-1.3|||||2-Sided|95.0|-3.64|0.55||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1657046|NCT01595438|3049513|Superiority or Other||Diff of clinical cure rates|1.3|||||2-Sided|95.0|-3.71|6.3||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1657047|NCT01595438|3049514|Superiority or Other||Diff of clinical cure rates|-0.1|||||2-Sided|95.0|-4.23|4.03||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1657048|NCT01595438|3049515|Superiority or Other||Diff of clinical cure rates|-1.4|||||2-Sided|95.0|-4.07|1.02||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of clinical cure rates|
1657049|NCT01595438|3049516|Superiority or Other||Diff of favorable response rates|9.7|||||2-Sided|95.0|1.72|17.55||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1657050|NCT01595438|3049517|Superiority or Other||Diff of favorable response rates|7.3|||||2-Sided|95.0|0.88|13.74||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1657051|NCT01595438|3049518|Superiority or Other||Diff of favorable response rates|0.2|||||2-Sided|95.0|-1.17|1.68||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1657052|NCT01595438|3049519|Superiority or Other||Diff of favorable response rates|10.9|||||2-Sided|95.0|2.86|18.85||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1657053|NCT01595438|3049520|Superiority or Other||Diff of favorable response rates|8.8|||||2-Sided|95.0|2.27|15.24||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1657054|NCT01595438|3049521|Superiority or Other||Diff of favorable response rates|0.2|||||2-Sided|95.0|-1.21|1.72||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1657055|NCT01595438|3049522|Superiority or Other||Diff of favorable response rates|7.3|||||2-Sided|95.0|0.68|13.81||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1657056|NCT01595438|3049523|Superiority or Other||Diff of favorable response rates|0.4|||||2-Sided|95.0|-2.7|3.56||||||Confidence interval of the difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates|
1657057|NCT01595438|3049524|Non-Inferiority or Equivalence|-12.5%|Diff of favorable response rates|6.4|||||2-Sided|95.0|0.33|12.36||||||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable response rates ≤ non-inferiority margin|
1657058|NCT01595438|3049525|Non-Inferiority or Equivalence|-12.5%|Diff of favorable combined resp rates|6.7|||||2-Sided|95.0|0.3|13.12||||||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of favorable combined response rates ≤ non-inferiority margin|
1657059|NCT01595438|3049526|Non-Inferiority or Equivalence|-12.5%|Difference of symp resolution rates|4.0|||||2-Sided|95.0|-2.39|10.42||||||H0: Difference (CAZ-AVI treatment group minus Doripenem treatment group) of symptomatic resolution rates ≤ non-inferiority margin|
1657060|NCT01595386|3049527|Non-Inferiority or Equivalence|There was not a power calculation for this statistic||||||0.02||||||Development of Low cardiac output syndrome in subjects with Adrenal Insufficiency.A p-value of <0.05 is the threshold for statistical significance.|Fisher Exact||||
1657061|NCT01595386|3049527|Non-Inferiority or Equivalence|There was not a power calculation for this statistic||||||0.004||||||Adrenal Insufficiency after bypass.A p-value of <0.05 is the threshold for statistical significance.|Fisher Exact||||
1657062|NCT01595386|3049527|Non-Inferiority or Equivalence|There was not a power calculation for this statistic|||||<|0.001||||||post-operative cortisol.A p-value of <0.05 is the threshold for statistical significance.|Fisher Exact||||
1657063|NCT01595386|3049527|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.|||||<|0.05|||||||Fisher Exact||||
1657064|NCT01595386|3049528|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.23|||||||Fisher Exact||||
1657065|NCT01595386|3049529|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.76|||||||Wilcoxon (Mann-Whitney)||||
1657066|NCT01595386|3049530|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.7|||||||Wilcoxon (Mann-Whitney)||||
1657067|NCT01595386|3049531|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1657068|NCT01595386|3049532|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.04|||||||Wilcoxon (Mann-Whitney)||||
1657069|NCT01595386|3049533|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.|||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1657070|NCT01595386|3049534|Non-Inferiority or Equivalence|There was not a power calculation for this statistic||||||0.03||||||IL-10 at 4 hours.A p-value of <0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)||||
1657071|NCT01595386|3049534|Non-Inferiority or Equivalence|There was not a power calculation for this statistic|||||<|0.05||||||Interleukin-8 at 24 and 48 hours.A p-value of <0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)||||
1657072|NCT01595386|3049534|Non-Inferiority or Equivalence|There was not a power calculation for this statistic|||||<|0.05||||||Interleukin1-beta at 24 and 48 hours.A p-value of <0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)||||
1657073|NCT01595386|3049534|Non-Inferiority or Equivalence|There was not a power calculation for this statistic|||||<|0.01||||||TNF-alpha at 12, 24, and 48 hours.A p-value of <0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)||||
1657220|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|3.107|||<|0.01|2-Sided|95.0|1.304|7.401|||Regression, Logistic|||Week 12, Less than 100 mg/dL|
1657074|NCT01595386|3049534|Non-Inferiority or Equivalence|There was not a power calculation for this statistic|||||<|0.01||||||interleukin-6 at 12, 24, and 48 hour. A p-value of <0.05 is the threshold for statistical significance.|Wilcoxon (Mann-Whitney)||||
1657075|NCT01595386|3049534|Non-Inferiority or Equivalence|There was not a power calculation for this statistic|||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1657076|NCT01595386|3049535|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.62|||||||Wilcoxon (Mann-Whitney)||||
1657077|NCT01595386|3049536|Non-Inferiority or Equivalence|Power calculations were not performed on this statistical calculation.||||||0.44|||||||Chi-squared||||
1657078|NCT01595386|3049537|Non-Inferiority or Equivalence|Study sample size was powered to detect a 60% difference in LCOS between groups at α 0.05 and β 0.70, assuming the prevalence of LCOS after neonatal bypass of 65% (based on retrospective data of patients who died, required rescue steroids, ECMO, or epinephrine > 0.1 μg/kg/min).||||||0.049||||||A p-value of <0.05 represents the threshold for statistical significance.|t-test, 2 sided||||
1657079|NCT01594749|3049571|Superiority or Other||||||<|0.001||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen|
1657080|NCT01594749|3049572|Superiority or Other|||||||0.184||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen|
1657081|NCT01594749|3049573|Superiority or Other||||||<|0.001||||||P-value based on CMH method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen|
1657082|NCT01594749|3049575|Superiority or Other||Difference in percentage vs. Control|0.6||||0.085|2-Sided|95.0|-0.2|1.7||P-value based on Miettinen & Nurminen method|Miettinen & Nurminen method||||
1657083|NCT01594749|3049576|Superiority or Other||||||<|0.001||||||P-value based on Cochran-Mantel-Haenszel (CMH) method with stratification of gender|Cochran-Mantel-Haenszel|||Percentage difference in Fosaprepitant Regimen vs. Control Regimen|
1657084|NCT01594528|3049577|Other|||||||0.586||||||comparison between groups for vocal indicators|Wilcoxon (Mann-Whitney)||||
1657085|NCT01594528|3049577|Other|||||||0.8||||||comparison between groups facial indicators|Wilcoxon (Mann-Whitney)||||
1657086|NCT01594528|3049577|Other|||||||0.992||||||comparison between groups for body indicators|Wilcoxon (Mann-Whitney)||||
1657087|NCT01594515|3049578|Superiority or Other||Slope|1.0442|Standard Error of the Mean|0.0148|||2-Sided|95.0|1.0145|1.074|||||"Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1.~PK endpoints on the log-transformed scale."|This was non confirmatory testing (Single dose). Dose proportionality of the drug for AUC0-inf was analysed. (N=48)|
1657088|NCT01594515|3049579|Superiority or Other||Slope|0.9702|Standard Error of the Mean|0.0151|||2-Sided|95.0|0.94|1.0005|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale.|This was non confirmatory testing (Single dose). Dose proportionality of the drug for Cmax was analysed.(N=50)|
1657089|NCT01594411|3049593|Superiority or Other||||||<|0.001|||||||one-sided binomial with alpha level of 0|||"The proportion of patients whose final treatment plan changes from the preliminary will be estimated, and a one-sided binomial test with alpha level of .05 will be used to test whether it is greater than 10%.~This is the level at which it is assumed that patient management has been modified by a practically important amount."|
1657090|NCT01594281|3049610|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|22.8||||0.1288|2-Sided|95.0|-6.7|52.3|||ANCOVA||||
1657091|NCT01594281|3049610|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-28.9||||0.0542|2-Sided|95.0|-58.4|0.5|||ANCOVA||||
1657092|NCT01594281|3049610|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-51.7||||0.0007|2-Sided|95.0|-81.1|-22.3|||ANCOVA||||
1657093|NCT01594281|3049611|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|17.8||||0.1034|2-Sided|95.0|-3.7|39.3|||ANCOVA||||
1657094|NCT01594281|3049611|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-22.9||||0.0357|2-Sided|95.0|-44.2|-1.6|||ANCOVA||||
1657095|NCT01594281|3049611|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-40.7||||0.0003|2-Sided|95.0|-62.1|-19.3|||ANCOVA||||
1657096|NCT01594281|3049612|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.383||||0.2792|2-Sided|95.0|0.068|2.177|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS|
1657097|NCT01594281|3049612|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.341||||0.223|2-Sided|95.0|0.06|1.925|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS|
1657098|NCT01594281|3049612|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.889||||0.9097|2-Sided|95.0|0.116|6.806|||Regression, Logistic|||≥ 2 class improvement from Baseline at EOCS|
1657099|NCT01594281|3049612|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.611||||0.3787|2-Sided|95.0|0.204|1.83|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS|
1657524|NCT01587989|3050239|Superiority or Other|||||||0.975|||||||Wilcoxon (Mann-Whitney)|||Side-effects|
1657100|NCT01594281|3049612|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.607||||0.3595|2-Sided|95.0|0.209|1.765|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS|
1657101|NCT01594281|3049612|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.994||||0.9918|2-Sided|95.0|0.327|3.026|||Regression, Logistic|||≥ 1 class improvement from Baseline at EOCS|
1657102|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|3.282||||0.314|2-Sided|95.0|0.325|33.171|||Regression, Logistic|||≥15 letters loss|
1657103|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.6632|2-Sided|95.0|0.294|6.856|||Regression, Logistic|||≥10 letters loss|
1657104|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.773||||0.271|2-Sided|95.0|0.64|4.913|||Regression, Logistic|||≥5 letters loss|
1657105|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.477||||0.1259|2-Sided|95.0|0.185|1.231|||Regression, Logistic|||No clinically relevant change|
1657106|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.55||||0.4941|2-Sided|95.0|0.441|5.444||P-value was calculated as a point estimate.|Regression, Logistic|||≥5 letters gain|
1657107|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.663|2-Sided|95.0|0.294|6.858|||Regression, Logistic|||≥10 letters gain|
1657108|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.029||||0.9839|2-Sided|95.0|0.062|17.127|||Regression, Logistic|||≥15 letters loss|
1657109|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.419||||0.6632|2-Sided|95.0|0.294|6.856|||Regression, Logistic|||≥10 letters loss|
1657110|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.621||||0.4197|2-Sided|95.0|0.195|1.977|||Regression, Logistic|||≥5 letters loss|
1657111|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.674||||0.4116|2-Sided|95.0|0.263|1.729|||Regression, Logistic|||No clinically relevant change|
1657112|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|2.842||||0.0838|2-Sided|95.0|0.87|9.283|||Regression, Logistic|||≥5 letters gain|
1657113|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.667||||0.668|2-Sided|95.0|0.104|4.253|||Regression, Logistic|||≥10 letters gain|
1657114|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.314||||0.3261|2-Sided|95.0|0.031|3.173|||Regression, Logistic|||≥15 letters loss|
1657115|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.0||||1|2-Sided|95.0|0.229|4.361|||Regression, Logistic|||≥10 letters loss|
1657116|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.35||||0.065|2-Sided|95.0|0.155|1.068|||Regression, Logistic|||≥5 letters loss|
1657117|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.412||||0.4731|2-Sided|95.0|0.55|3.622|||Regression, Logistic|||No clinically relevant change|
1657118|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|1.833||||0.2772|2-Sided|95.0|0.614|5.471|||Regression, Logistic|||≥5 letters gain|
1657119|NCT01594281|3049613|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Odds Ratio (OR)|0.47||||0.4019|2-Sided|95.0|0.08|2.749|||Regression, Logistic|||≥10 letters gain|
1657120|NCT01594281|3049614|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.5||||0.3641|2-Sided|95.0|-7.9|2.9|||ANCOVA||||
1657121|NCT01594281|3049614|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|3.0||||0.2767|2-Sided|95.0|-2.5|8.5|||ANCOVA||||
1657122|NCT01594281|3049614|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|5.5||||0.0495|2-Sided|95.0|0.0|11.0|||ANCOVA||||
1657123|NCT01594281|3049615|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|2.1||||0.0175|2-Sided|95.0|0.4|3.9|||ANCOVA||||
1657124|NCT01594281|3049615|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-0.3||||0.7494|2-Sided|95.0|-2.0|1.5|||ANCOVA||||
1657125|NCT01594281|3049615|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.4||||0.0081|2-Sided|95.0|-4.2|-0.6|||ANCOVA||||
1657126|NCT01594281|3049616|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|1.7||||0.2113|2-Sided|95.0|-1.0|4.3|||ANCOVA||||
1657127|NCT01594281|3049616|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-1.2||||0.3809|2-Sided|95.0|-3.8|1.5|||ANCOVA||||
1657128|NCT01594281|3049616|Other|The focus of this PoC study was not on hypothesis testing but on a rough estimation of differences between treatments. The usual p-values are provided as a descriptive tool.|Least Squares Mean Difference|-2.8||||0.0344|2-Sided|95.0|-5.4|-0.2|||ANCOVA||||
1657129|NCT01593852|3049622|Non-Inferiority or Equivalence|Based on historical dose observations, a sample size of 68 patients per study group (i.e. 62 evaluable patients for 10% dropout rate) for a total of 136 patient randomized will allow for 80% power to detect for approximately 40% reduction in dose area product (DAP). This sample size will allow for detection of approximately 40% reduction in air kerma (AK). No adjustment for multiple endpoints was performed as both endpoints are assessing radiation dose.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1657130|NCT01593852|3049630|Non-Inferiority or Equivalence|Based on historical dose observations, a sample size of 68 patients per study group (i.e. 62 evaluable patients for 10% dropout rate) for a total of 136 patient randomized will allow for 80% power to detect for approximately 40% reduction in dose area product (DAP). This sample size will allow for detection of approximately 40% reduction in air kerma (AK). No adjustment for multiple endpoints was performed as both endpoints are assessing radiation dose.|||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1657131|NCT01593722|3049648|Superiority or Other|||||||0.68|||||||Wilcoxon (Mann-Whitney)||||
1657132|NCT01593592|3049655|Superiority or Other||percentage|0.0|||||2-Sided|95.0||||||||A total of 70 patients were included; 35 in each arm. The sample size was calculated assuming eradication of H. pylori in at least 70% of treated patients, aiming to detect a difference of 30% based on a 0.80 power to detect significant difference (p =0.05, two-sided).|
1657133|NCT01593254|3049661|Superiority|||||||0.005|||||||Cochran-Mantel-Haenszel||||
1657134|NCT01592864|3049664|Superiority or Other||Adjusted Mean Difference|9.6|||<|0.0001|2-Sided|95.0|5.4|13.9||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favors first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.|
1657135|NCT01592864|3049665|Superiority or Other||Adjusted Mean Difference|16.9|||<|0.0001|2-Sided|95.0|11.1|22.8||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.|
1657136|NCT01592864|3049666|Superiority or Other||Adjusted Mean Difference|-0.4|||<|0.0001|2-Sided|95.0|-0.6|-0.3||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.|
1657137|NCT01592864|3049667|Superiority or Other||Adjusted Mean Difference|-0.4|||<|0.0001|2-Sided|95.0|-0.6|-0.2||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.|
1657138|NCT01592851|3049668|Superiority or Other||Adjusted Mean DIfference|3.87||||0.007|2-Sided|95.0|1.08|6.65||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.|
1657139|NCT01592851|3049669|Superiority or Other||Adjusted Mean Difference|6.84||||0.0021|2-Sided|95.0|2.54|11.13||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.|
1657140|NCT01592851|3049670|Superiority or Other||Adjusted Mean Difference|19.42|||<|0.0001|2-Sided|95.0|13.7|25.15||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a positive difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.|
1657141|NCT01592851|3049671|Superiority or Other||Adjusted Mean Difference|-0.45|||<|0.0001|2-Sided|95.0|-0.63|-0.28||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.|
1657221|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|12.842|||<|0.001|2-Sided|95.0|3.674|44.892|||Regression, Logistic|||Week 12, Less than 100 mg/dL|
1657142|NCT01592851|3049672|Superiority or Other||Adjusted Mean Difference|-0.26||||0.0006|2-Sided|95.0|-0.41|-0.12||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.|
1657143|NCT01592851|3049673|Superiority or Other||Adjusted Mean Difference|-0.83|||<|0.0001|2-Sided|95.0|-1.03|-0.63||No adjustment made for multiple comparisons, as primary comparison was pre-specified.|ANCOVA|ANCOVA with treatment as fixed factor and baseline Schiff Score as covariate.|Difference is 0.454% SnF minus 0.76% NaMFP such that a negative difference favours first named treatment.|Null hypothesis considered change from baseline to be same for both treatments.|
1657144|NCT01592747|3049703|Superiority or Other||Least squares mean difference|0.4||||0.2855|2-Sided|95.0|-0.3|1.1|||ANCOVA||||
1657145|NCT01592747|3049703|Superiority or Other||Least squares mean difference|0.3||||0.3713||95.0|-0.4|1.0|||ANCOVA||||
1657146|NCT01592747|3049704|Superiority or Other||Least squares mean difference|0.3||||0.4267|2-Sided|95.0|-0.4|1.0|||ANCOVA||||
1657147|NCT01592747|3049704|Superiority or Other||Least squares mean difference|0.3||||0.4213|2-Sided|95.0|-0.4|1.0|||ANCOVA||||
1657148|NCT01592747|3049705|Superiority or Other||Least squares mean difference|0.3||||0.4365|2-Sided|95.0|-0.4|1.0|||ANCOVA||||
1657149|NCT01592747|3049705|Superiority or Other||Least squares mean difference|0.7||||0.0813|2-Sided|95.0|-0.1|1.4|||ANCOVA||||
1657150|NCT01592747|3049706|Superiority or Other||Least squares mean difference|-0.1||||0.839|2-Sided|95.0|-0.8|0.6|||ANCOVA||||
1657151|NCT01592747|3049706|Superiority or Other||Least squares mean difference|-0.1||||0.7182|2-Sided|95.0|-0.8|0.6|||ANCOVA||||
1657152|NCT01592747|3049707|Superiority or Other||Least squares mean difference|0.3||||0.4362|2-Sided|95.0|-0.4|0.9|||ANCOVA||||
1657153|NCT01592747|3049707|Superiority or Other||Least squares mean difference|0.1||||0.864|2-Sided|95.0|-0.6|0.7|||ANCOVA||||
1657154|NCT01592747|3049708|Superiority or Other||Least squares mean difference|0.2||||0.5957|2-Sided|95.0|-0.5|0.9|||ANCOVA||||
1657155|NCT01592747|3049708|Superiority or Other||Least squares mean difference|-0.2||||0.6238|2-Sided|95.0|-0.9|0.5|||ANCOVA||||
1657156|NCT01592747|3049709|Superiority or Other||Least squares mean difference|0.3||||0.4212|2-Sided|95.0|-0.4|1.0|||ANCOVA||||
1657157|NCT01592747|3049709|Superiority or Other||Least squares mean difference|0.3||||0.4144|2-Sided|95.0|-0.4|1.1|||ANCOVA||||
1657158|NCT01592747|3049710|Superiority or Other||Least squares mean difference|0.4||||0.1279|2-Sided|95.0|-0.1|1.0|||ANCOVA||||
1657159|NCT01592747|3049710|Superiority or Other||Least squares mean difference|0.0||||0.902|2-Sided|95.0|-0.5|0.6|||ANCOVA||||
1657160|NCT01592747|3049711|Superiority or Other||Least squares mean difference|0.3||||0.3176|2-Sided|95.0|-0.3|0.9|||ANCOVA||||
1657161|NCT01592747|3049711|Superiority or Other||Least squares mean difference|0.1||||0.7611|2-Sided|95.0|-0.5|0.7|||ANCOVA||||
1657162|NCT01592747|3049712|Superiority or Other||Least squares mean difference|0.0||||0.9244|2-Sided|95.0|-0.6|0.5|||ANCOVA||||
1657163|NCT01592747|3049712|Superiority or Other||Least squares mean difference|0.1||||0.8136|2-Sided|95.0|-0.5|0.7|||ANCOVA||||
1657164|NCT01592747|3049714|Superiority or Other||Odds Ratio (OR)|1.1||||0.7839|2-Sided|95.0|0.7|1.7|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test was performed controlling for Autism Spectrum Disorder (ASD) subtype. Odds ratio was calculated for placebo vs. Memantine reduced dose|
1657165|NCT01592747|3049714|Superiority or Other||Odds Ratio (OR)|1.1||||0.659|2-Sided|95.0|0.7|1.8|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test was performed controlling for Autism Spectrum Disorder (ASD) subtype. Odds ratio was calculated for placebo vs. memantine full dose.|
1657166|NCT01592435|3049732|Superiority or Other|||||||0||||||level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.|t-test, 1 sided||||
1657167|NCT01592435|3049733|Superiority or Other|||||||0.02||||||level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.|t-test, 1 sided||||
1657168|NCT01592344|3049748|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1657169|NCT01592344|3049749|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1657170|NCT01592344|3049750|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1657171|NCT01592344|3049751|Superiority or Other|||||||0.0048|||||||Cochran-Mantel-Haenszel||||
1657172|NCT01592292|3049753|Superiority or Other|||||||0.1167||||||Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.|ANCOVA||||
1657173|NCT01592292|3049754|Superiority or Other|||||||0.0568||||||Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.|ANCOVA||||
1657174|NCT01592292|3049755|Superiority or Other|||||||0.1805||||||Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657175|NCT01592292|3049755|Superiority or Other|||||||0.1894||||||Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657176|NCT01592292|3049756|Superiority or Other|||||||0.1826||||||Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657177|NCT01592292|3049756|Superiority or Other|||||||0.49||||||Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657178|NCT01592292|3049757|Superiority or Other|||||||0.5849||||||Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657179|NCT01592292|3049757|Superiority or Other|||||||0.2282||||||Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657525|NCT01587989|3050239|Superiority or Other|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||Effectiveness|
1657180|NCT01592292|3049758|Superiority or Other|||||||0.5808||||||Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.|ANCOVA||||
1657181|NCT01592292|3049758|Superiority or Other|||||||0.8987||||||Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.|ANCOVA||||
1657182|NCT01592292|3049759|Superiority or Other|||||||0.7644||||||Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657183|NCT01592292|3049759|Superiority or Other|||||||0.2549||||||Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657184|NCT01592292|3049760|Superiority or Other|||||||0.2542||||||Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657185|NCT01592292|3049760|Superiority or Other|||||||0.5306||||||Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657186|NCT01592292|3049761|Superiority or Other|||||||0.3903||||||Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657187|NCT01592292|3049761|Superiority or Other|||||||0.2444||||||Change in TJC at Month 6 was performed using ANCOVA with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657188|NCT01592292|3049762|Superiority or Other|||||||0.7097||||||Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657189|NCT01592292|3049762|Superiority or Other|||||||0.3212||||||Change in TJC at Month 6 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.|ANCOVA||||
1657190|NCT01592292|3049763|Superiority or Other|||||||0.239||||||Change in DAS28 at Month 12 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.|ANCOVA||||
1657191|NCT01592292|3049764|Superiority or Other|||||||0.0951||||||Change in DAS28 at Month 6 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.|ANCOVA||||
1657192|NCT01592292|3049765|Superiority or Other|||||||0.3037||||||Change in DAS28 at Month 6 was performed using analysis of covariance (ANCOVA) model with baseline DAS28 score and rheumatoid factor (RF) status as covariate values.|ANCOVA||||
1657193|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|0.925||||1|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL|
1657194|NCT01592240|3049766|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL.|
1657195|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|1.587|||<|1|||||||Regression, Logistic|||Week 24, Less than 25 mg/dL|
1657196|NCT01592240|3049766|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.|
1657197|NCT01592240|3049766|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.|
1657198|NCT01592240|3049766|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 25 mg/dL.|
1657199|NCT01592240|3049766|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.|
1657200|NCT01592240|3049766|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.|
1657201|NCT01592240|3049766|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||Week 24, Less than 40 mg/dL.|
1657202|NCT01592240|3049766|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.|
1657203|NCT01592240|3049766|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.|
1657204|NCT01592240|3049766|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 40 mg/dL.|
1657205|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|36.841|||<|0.001|2-Sided|95.0|4.527|299.817|||Regression, Logistic|||Week 24, Less than 70 mg/dL|
1657206|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|11.7|||<|0.023|2-Sided|95.0|1.396|98.075|||Regression, Logistic|||Week 24, Less than 70 mg/dL.|
1657207|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|42.101|||<|0.001|2-Sided|95.0|10.621|166.894|||Regression, Logistic|||Week 24, Less than 70 mg/dL.|
1657208|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|80.004|||<|0.001|2-Sided|95.0|18.094|353.742|||Regression, Logistic|||Week 24, Less than 70 mg/dL.|
1657209|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|24.941|||<|0.001|2-Sided|95.0|6.336|98.169|||Regression, Logistic|||Week 24, Less than 70 mg/dL.|
1657210|NCT01592240|3049766|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||Week 12, Less than 70 mg/dL.|
1657211|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|100.667|||<|0.001|2-Sided|95.0|19.855|510.387|||Regression, Logistic|||Week 12, Less than 70 mg/dL|
1657212|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|71.177|||<|0.001|2-Sided|95.0|13.783|367.564|||Regression, Logistic|||Week 12, Less than 70 mg/dL|
1657213|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|27.703|||<|0.001|2-Sided|95.0|5.752|133.423|||Regression, Logistic|||Week 12, Less than 70 mg/dL|
1657214|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|6.205|||<|0.001|2-Sided|95.0|2.06|18.693|||Regression, Logistic|||Week 24, Less than 100 mg/dL|
1657215|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|6.219|||<|0.001|2-Sided|95.0|2.061|18.764|||Regression, Logistic|||Week 24, Less than 100 mg/dL|
1657216|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|20.75|||<|0.001|2-Sided|95.0|5.741|75.006|||Regression, Logistic|||Week 24, Less than 100 mg/dL|
1657217|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|36.886|||<|0.001|2-Sided|95.0|8.33|163.335|||Regression, Logistic|||Week 24, Less than 100 mg/dL|
1657218|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|12.773|||<|0.001|2-Sided|95.0|3.932|41.495|||Regression, Logistic|||Week 24, Less than 100 mg/dL|
1657219|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|6.048|||<|0.001|2-Sided|95.0|2.402|15.225|||Regression, Logistic|||Week 12, Less than 100 mg/dL|
1657222|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|49.615|||<|0.001|2-Sided|95.0|7.984|308.328|||Regression, Logistic|||Week 12, Less than 100 mg/dL|
1657223|NCT01592240|3049766|Superiority or Other||Odds Ratio (OR)|14.964|||<|0.001|2-Sided|95.0|3.997|56.02|||Regression, Logistic|||Week 12, Less than 100 mg/dL|
1657224|NCT01592240|3049780|Superiority or Other||Adjusted mean difference|-1.33||||0.565|2-Sided|95.0|-5.91|3.24|||Mixed models repeated measures analysis|||Week 24|
1657225|NCT01592240|3049780|Superiority or Other||Adjusted mean difference|-1.99||||0.392|2-Sided|95.0|-6.57|2.59|||Mixed models repeated measures analysis|||Week 24|
1657226|NCT01592240|3049780|Superiority or Other||Adjusted mean difference|3.04||||0.839|2-Sided|95.0|-26.39|32.47|||Mixed models repeated measures analysis|||Week 24|
1657227|NCT01592240|3049780|Superiority or Other||Adjusted mean difference|-2.69||||0.855|2-Sided|95.0|-31.76|26.38|||Mixed models repeated measures analysis|||Week 24|
1657228|NCT01592240|3049780|Superiority or Other||Adjusted mean difference|9.8||||0.509|2-Sided|95.0|-19.41|39.01|||Mixed models repeated measures analysis|||Week 24|
1657229|NCT01592240|3049780|Superiority or Other||Adjusted mean difference|1.08||||0.75|2-Sided|95.0|-5.61|7.77|||Mixed models repeated measures analysis|||Week 12|
1657230|NCT01592240|3049780|Superiority or Other||Adjusted mean difference|-1.58||||0.64|2-Sided|95.0|-8.25|5.09|||Mixed models repeated measures analysis|||Week 12|
1657231|NCT01592240|3049780|Superiority or Other||Adjusted mean difference|0.54||||0.974|2-Sided|95.0|-31.72|32.8|||Mixed models repeated measures analysis|||Week 12|
1657232|NCT01592240|3049780|Superiority or Other||Adjusted mean difference|0.39||||0.981|2-Sided|95.0|-31.49|32.26|||Mixed models repeated measures analysis|||Week 12|
1657233|NCT01592240|3049780|Superiority or Other||Adjusted mean difference|10.29||||0.527|2-Sided|95.0|-21.73|42.3|||Mixed models repeated measures analysis|||Week 12|
1657234|NCT01592240|3049781|Superiority or Other||Adjusted mean difference|-0.39||||0.694|2-Sided|95.0|-2.36|1.58|||Mixed models repeated measures analysis|||Week 24|
1657235|NCT01592240|3049781|Superiority or Other||Adjusted mean difference|-0.69||||0.488|2-Sided|95.0|-2.67|1.28|||Mixed models repeated measures analysis|||Week 24|
1657236|NCT01592240|3049781|Superiority or Other||Adjusted mean difference|1.03||||0.42|2-Sided|95.0|-1.49|3.56|||Mixed models repeated measures analysis|||Week 24|
1657237|NCT01592240|3049781|Superiority or Other||Adjusted mean difference|0.9||||0.483|2-Sided|95.0|-1.62|3.41|||Mixed models repeated measures analysis|||Week 24|
1657238|NCT01592240|3049781|Superiority or Other||Adjusted mean difference|1.66||||0.199|2-Sided|95.0|-0.88|4.2|||Mixed models repeated measures analysis|||Week 24|
1657239|NCT01592240|3049781|Superiority or Other||Adjusted mean difference|0.41||||0.768|2-Sided|95.0|-2.31|3.12|||Mixed models repeated measures analysis|||Week 12|
1657240|NCT01592240|3049781|Superiority or Other||Adjusted mean difference|-0.49||||0.719|2-Sided|95.0|-3.2|2.21|||Mixed models repeated measures analysis|||Week 12|
1657241|NCT01592240|3049781|Superiority or Other||Adjusted mean difference|-0.64||||0.655|2-Sided|95.0|-3.45|2.17|||Mixed models repeated measures analysis|||Week 12|
1657242|NCT01592240|3049781|Superiority or Other||Adjusted mean difference|1.33||||0.355|2-Sided|95.0|-1.49|4.15|||Mixed models repeated measures analysis|||Week 12|
1657243|NCT01592240|3049781|Superiority or Other||Adjusted Mean Difference|0.19||||0.893|2-Sided|95.0|-2.62|3.0|||Mixed models repeated measures analysis|||Week 12|
1657244|NCT01592240|3049782|Superiority or Other||Adjusted mean difference|-1.55||||0.55|2-Sided|95.0|-6.68|3.57|||Mixed models repeated measures analysis|||Week 24|
1657245|NCT01592240|3049782|Superiority or Other||Adjusted mean difference|-0.83||||0.752|2-Sided|95.0|-5.99|4.34|||Mixed models repeated measures analysis|||Week 24|
1657246|NCT01592240|3049782|Superiority or Other||Adjusted mean difference|5.82||||0.108|2-Sided|95.0|-1.29|12.93|||Mixed models repeated measures analysis|||Week 24|
1657247|NCT01592240|3049782|Superiority or Other||Adjusted mean difference|-1.15||||0.749|2-Sided|95.0|-8.24|5.94|||Mixed models repeated measures analysis|||Week 24|
1657248|NCT01592240|3049782|Superiority or Other||Adjusted mean difference|-0.86||||0.812|2-Sided|95.0|-8.01|6.29|||Mixed models repeated measures analysis|||Week 24|
1657249|NCT01592240|3049782|Superiority or Other||Adjusted mean difference|2.67||||0.218|2-Sided|95.0|-1.6|6.94|||Mixed models repeated measures analysis|||Week 12|
1657250|NCT01592240|3049782|Superiority or Other||Adjusted mean difference|3.5||||0.109|2-Sided|95.0|-0.79|7.8|||Mixed models repeated measures analysis|||Week 12|
1657251|NCT01592240|3049782|Superiority or Other||Adjusted mean difference|6.54||||0.172|2-Sided|95.0|-2.86|15.94|||Mixed models repeated measures analysis|||Week 12|
1657252|NCT01592240|3049782|Superiority or Other||Adjusted mean difference|2.32||||0.625|2-Sided|95.0|-7.04|11.68|||Mixed models repeated measures analysis|||Week 12|
1657253|NCT01592240|3049782|Superiority or Other||Adjusted mean difference|-0.66||||0.89|2-Sided|95.0|-10.05|8.74|||Mixed models repeated measures analysis|||Week 12|
1657254|NCT01592240|3049783|Superiority or Other||Adjusted mean difference|-2.19||||0.587|2-Sided|95.0|-10.13|5.75|||Mixed models repeated measures analysis|||Week 24|
1657255|NCT01592240|3049783|Superiority or Other||Adjusted mean difference|-1.41||||0.728|2-Sided|95.0|-9.41|6.59|||Mixed models repeated measures analysis|||Week 24|
1657256|NCT01592240|3049783|Superiority or Other||Adjusted mean difference|4.12||||0.283|2-Sided|95.0|-3.44|11.69|||Mixed models repeated measures analysis|||Week 24|
1657257|NCT01592240|3049783|Superiority or Other||Adjusted mean difference|0.43||||0.911|2-Sided|95.0|-7.17|8.02|||Mixed models repeated measures analysis|||Week 24|
1657258|NCT01592240|3049783|Superiority or Other||Adjusted mean difference|0.59||||0.879|2-Sided|95.0|-7.09|8.28|||Mixed models repeated measures analysis|||Week 24|
1657259|NCT01592240|3049783|Superiority or Other||Adjusted mean difference|4.36||||0.184|2-Sided|95.0|-2.1|10.82|||Mixed models repeated measures analysis|||Week 12|
1657260|NCT01592240|3049783|Superiority or Other||Adjusted mean difference|5.6||||0.09|2-Sided|95.0|-0.89|12.09|||Mixed models repeated measures analysis|||Week 12|
1657261|NCT01592240|3049783|Superiority or Other||Adjusted mean difference|3.82||||0.352|2-Sided|95.0|-4.25|11.9|||Mixed models repeated measures analysis|||Week 12|
1657262|NCT01592240|3049783|Superiority or Other||Adjusted mean difference|5.44||||0.187|2-Sided|95.0|-2.66|13.54|||Mixed models repeated measures analysis|||Week 12|
1657263|NCT01592240|3049783|Superiority or Other||Adjusted Mean Difference|1.77||||0.667|2-Sided|95.0|-6.33|9.88|||Mixed models repeated measures analysis|||Week 12|
1657264|NCT01592240|3049784|Superiority or Other||Adjusted mean difference|-19.15|||<|0.001|2-Sided|95.0|-26.7|-11.59|||Mixed models repeated measures analysis|||Week 24|
1657265|NCT01592240|3049784|Superiority or Other||Adjusted mean difference|-15.34|||<|0.001|2-Sided|95.0|-22.9|-7.78|||Mixed models repeated measures analysis|||Week 24|
1657266|NCT01592240|3049784|Superiority or Other||Adjusted mean difference|-27.23|||<|0.001|2-Sided|95.0|-35.38|-19.09|||Mixed models repeated measures analysis|||Week 24|
1657267|NCT01592240|3049784|Superiority or Other||Adjusted mean difference|-30.95|||<|0.001|2-Sided|95.0|-39.13|-22.77|||Mixed models repeated measures analysis|||Week 24|
1657268|NCT01592240|3049784|Superiority or Other||Adjusted mean difference|-22.09|||<|0.001|2-Sided|95.0|-30.32|-13.86|||Mixed models repeated measures analysis|||Week 24|
1657269|NCT01592240|3049784|Superiority or Other||Adjusted mean difference|-30.72|||<|0.001|2-Sided|95.0|-39.45|-21.98|||Mixed models repeated measures analysis|||Week 12|
1657270|NCT01592240|3049784|Superiority or Other||Adjusted mean difference|-17.14|||<|0.001|2-Sided|95.0|-25.87|-8.41|||Mixed models repeated measures analysis|||Week 12|
1657271|NCT01592240|3049784|Superiority or Other||Adjusted mean difference|-35.95|||<|0.001|2-Sided|95.0|-43.59|-28.31|||Mixed models repeated measures analysis|||Week 12|
1657272|NCT01592240|3049784|Superiority or Other||Adjusted mean difference|-30.54|||<|0.001|2-Sided|95.0|-38.19|-22.89|||Mixed models repeated measures analysis|||Week 12|
1657273|NCT01592240|3049784|Superiority or Other||Adjusted mean difference|-21.58|||<|0.001|2-Sided|95.0|-29.23|-13.92|||Mixed models repeated measures analysis|||Week 12|
1657274|NCT01592240|3049785|Superiority or Other||Adjusted mean difference|-16.85|||<|0.001|2-Sided|95.0|-23.47|-10.23|||Mixed models repeated measures analysis|||Week 24|
1657275|NCT01592240|3049785|Superiority or Other||Adjusted mean difference|-12.72|||<|0.001|2-Sided|95.0|-19.35|-6.09|||Mixed models repeated measures analysis|||Week 24|
1657276|NCT01592240|3049785|Superiority or Other||Adjusted mean difference|-25.41|||<|0.001|2-Sided|95.0|-32.73|-18.09|||Mixed models repeated measures analysis|||Week 24|
1657277|NCT01592240|3049785|Superiority or Other||Adjusted mean difference|-28.17|||<|0.001|2-Sided|95.0|-35.52|-20.82|||Mixed models repeated measures analysis|||Week 24|
1657278|NCT01592240|3049785|Superiority or Other||Adjusted mean difference|-19.67|||<|0.001|2-Sided|95.0|-27.07|-12.27|||Mixed models repeated measures analysis|||Week 24|
1657279|NCT01592240|3049785|Superiority or Other||Adjusted mean difference|-28.5|||<|0.001|2-Sided|95.0|-36.83|-20.16|||Mixed models repeated measures analysis|||Week 12|
1657280|NCT01592240|3049785|Superiority or Other||Adjusted mean difference|-14.56|||<|0.001|2-Sided|95.0|-22.89|-6.24|||Mixed models repeated measures analysis|||Week 12|
1657281|NCT01592240|3049785|Superiority or Other||Adjusted mean difference|-32.09|||<|0.001|2-Sided|95.0|-38.95|-25.22|||Mixed models repeated measures analysis|||Week 12|
1657282|NCT01592240|3049785|Superiority or Other||Adjusted mean difference|-27.67|||<|0.001|2-Sided|95.0|-34.55|-20.79|||Mixed models repeated measures analysis|||Week 12|
1657283|NCT01592240|3049785|Superiority or Other||Adjusted Mean Difference|-18.55|||<|0.001|2-Sided|95.0|-25.44|-11.67|||Mixed models repeated measures analysis|||Week 12|
1657284|NCT01592240|3049786|Superiority or Other||Adjusted mean difference|-0.7||||0.824|2-Sided|95.0|-6.87|5.48|||Mixed models repeated measures analysis|||Week 24|
1657285|NCT01592240|3049786|Superiority or Other||Adjusted mean difference|2.99||||0.343|2-Sided|95.0|-3.22|9.21|||Mixed models repeated measures analysis|||Week 24|
1657286|NCT01592240|3049786|Superiority or Other||Adjusted mean difference|2.57||||0.347|2-Sided|95.0|-2.81|7.95|||Mixed models repeated measures analysis|||Week 24|
1657287|NCT01592240|3049786|Superiority or Other||Adjusted mean difference|0.85||||0.758|2-Sided|95.0|-4.56|6.25|||Mixed models repeated measures analysis|||Week 24|
1657288|NCT01592240|3049786|Superiority or Other||Adjusted mean difference|3.9||||0.16|2-Sided|95.0|-1.56|9.36|||Mixed models repeated measures analysis|||Week 24|
1657289|NCT01592240|3049786|Superiority or Other||Adjusted mean difference|6.52||||0.043|2-Sided|95.0|0.22|12.83|||Mixed models repeated measures analysis|||Week 12|
1657290|NCT01592240|3049786|Superiority or Other||Adjusted mean difference|7.66||||0.018|2-Sided|95.0|1.33|13.99|||Mixed models repeated measures analysis|||Week 12|
1657291|NCT01592240|3049786|Superiority or Other||Adjusted mean difference|1.35||||0.643|2-Sided|95.0|-4.4|7.1|||Mixed models repeated measures analysis|||Week 12|
1657292|NCT01592240|3049786|Superiority or Other||Adjusted mean difference|2.62||||0.371|2-Sided|95.0|-3.14|8.38|||Mixed models repeated measures analysis|||Week 12|
1657293|NCT01592240|3049786|Superiority or Other||Adjusted mean difference|3.41||||0.246|2-Sided|95.0|-2.38|9.21|||Mixed models repeated measures analysis|||Week 12|
1657294|NCT01592240|3049787|Superiority or Other||Adjusted mean difference|-0.01||||0.996|2-Sided|95.0|-3.55|3.54|||Mixed models repeated measures analysis|||Week 24|
1657295|NCT01592240|3049787|Superiority or Other||Adjusted mean difference|2.01||||0.268|2-Sided|95.0|-1.56|5.57|||Mixed models repeated measures analysis|||Week 24|
1657296|NCT01592240|3049787|Superiority or Other||Adjusted mean difference|0.49||||0.725|2-Sided|95.0|-2.25|3.24|||Mixed models repeated measures analysis|||Week 24|
1657297|NCT01592240|3049787|Superiority or Other||Adjusted mean difference|0.79||||0.571|2-Sided|95.0|-1.97|3.56|||Mixed models repeated measures analysis|||Week 24|
1657298|NCT01592240|3049787|Superiority or Other||Adjusted mean difference|1.72||||0.225|2-Sided|95.0|-1.07|4.51|||Mixed models repeated measures analysis|||Week 24|
1657299|NCT01592240|3049787|Superiority or Other||Adjusted mean difference|3.86||||0.019|2-Sided|95.0|0.63|7.09|||Mixed models repeated measures analysis|||Week 12|
1657300|NCT01592240|3049787|Superiority or Other||Adjusted mean difference|4.45||||0.007|2-Sided|95.0|1.21|7.7|||Mixed models repeated measures analysis|||Week 12|
1657301|NCT01592240|3049787|Superiority or Other||Adjusted mean difference|0.53||||0.724|2-Sided|95.0|-2.43|3.5|||Mixed models repeated measures analysis|||Week 12|
1657302|NCT01592240|3049787|Superiority or Other||Adjusted mean difference|1.73||||0.251|2-Sided|95.0|-1.24|4.71|||Mixed models repeated measures analysis|||Week 12|
1657303|NCT01592240|3049787|Superiority or Other||Adjusted Mean Difference|1.64||||0.281|2-Sided|95.0|-1.35|4.63|||Mixed models repeated measures analysis|||Week 12|
1657304|NCT01592240|3049788|Superiority or Other||Adjusted mean difference|-29.08|||<|0.001|2-Sided|95.0|-38.13|-20.04|||Mixed models repeated measures analysis|||Week 24|
1657305|NCT01592240|3049788|Superiority or Other||Adjusted mean difference|-23.79|||<|0.001|2-Sided|95.0|-32.88|-14.7|||Mixed models repeated measures analysis|||Week 24|
1657306|NCT01592240|3049788|Superiority or Other||Adjusted mean difference|-39.16|||<|0.001|2-Sided|95.0|-48.37|-29.94|||Mixed models repeated measures analysis|||Week 24|
1657307|NCT01592240|3049788|Superiority or Other||Adjusted mean difference|-40.14|||<|0.001|2-Sided|95.0|-49.43|-30.86|||Mixed models repeated measures analysis|||Week 24|
1657308|NCT01592240|3049788|Superiority or Other||Adjusted mean difference|-29.09|||<|0.001|2-Sided|95.0|-38.42|-19.77|||Mixed models repeated measures analysis|||Week 24|
1657309|NCT01592240|3049788|Superiority or Other||Adjusted mean difference|-41.13|||<|0.001|2-Sided|95.0|-52.32|-29.94|||Mixed models repeated measures analysis|||Week 12|
1657310|NCT01592240|3049788|Superiority or Other||Adjusted mean difference|-26.96|||<|0.001|2-Sided|95.0|-38.25|-15.67|||Mixed models repeated measures analysis|||Week 12|
1657311|NCT01592240|3049788|Superiority or Other||Adjusted mean difference|-53.12|||<|0.001|2-Sided|95.0|-62.97|-43.27|||Mixed models repeated measures analysis|||Week 12|
1657312|NCT01592240|3049788|Superiority or Other||Adjusted mean difference|-42.32|||<|0.001|2-Sided|95.0|-52.3|-32.33|||Mixed models repeated measures analysis|||Week 12|
1657313|NCT01592240|3049788|Superiority or Other||Adjusted mean difference|-35.0|||<|0.001|2-Sided|95.0|-44.91|-25.1|||Mixed models repeated measures analysis|||Week 12|
1657314|NCT01592240|3049789|Superiority or Other||Adjusted mean difference|-30.36|||<|0.001|2-Sided|95.0|-40.24|-20.49|||Mixed models repeated measures analysis||||
1657315|NCT01592240|3049789|Superiority or Other||Adjusted mean difference|-23.77|||<|0.001|2-Sided|95.0|-33.7|-13.84|||Mixed models repeated measures analysis||||
1657316|NCT01592240|3049789|Superiority or Other||Adjusted mean difference|-41.03|||<|0.001|2-Sided|95.0|-51.66|-30.41|||Mixed models repeated measures analysis||||
1657317|NCT01592240|3049789|Superiority or Other||Adjusted mean difference|-43.21|||<|0.001|2-Sided|95.0|-53.9|-32.51|||Mixed models repeated measures analysis||||
1657318|NCT01592240|3049789|Superiority or Other||Adjusted mean difference|-28.41|||<|0.001|2-Sided|95.0|-39.15|-17.67|||Mixed models repeated measures analysis||||
1657319|NCT01592240|3049790|Superiority or Other||Adjusted mean difference|-44.85|||<|0.001|2-Sided|95.0|-57.65|-32.05|||Mixed models repeated measures analysis||||
1657320|NCT01592240|3049790|Superiority or Other||Adjusted mean difference|-27.58|||<|0.001|2-Sided|95.0|-40.49|-14.67|||Mixed models repeated measures analysis||||
1657321|NCT01592240|3049790|Superiority or Other||Adjusted mean difference|-53.42|||<|0.001|2-Sided|95.0|-64.14|-42.7|||Mixed models repeated measures analysis||||
1657322|NCT01592240|3049790|Superiority or Other||Adjusted mean difference|-45.07|||<|0.001|2-Sided|95.0|-55.93|-34.21|||Mixed models repeated measures analysis||||
1657323|NCT01592240|3049790|Superiority or Other||Adjusted mean difference|-34.28|||<|0.001|2-Sided|95.0|-45.06|-23.5|||Mixed models repeated measures analysis||||
1657324|NCT01591746|3049817|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1657325|NCT01591746|3049818|Superiority|||||||0.37|||||||Wilcoxon (Mann-Whitney)||||
1657326|NCT01591746|3049819|Superiority|||||||0.43|||||||Wilcoxon (Mann-Whitney)||||
1657327|NCT01591746|3049820|Superiority|||||||0.98|||||||Wilcoxon (Mann-Whitney)|||Left breast initial percent volume expansion|
1657328|NCT01591746|3049820|Superiority|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Right breast initial percent volume expansion|
1657329|NCT01591746|3049821|Superiority|||||||0.56|||||||Wilcoxon (Mann-Whitney)||||
1657330|NCT01591746|3049822|Superiority|||||||0.43|||||||Wilcoxon (Mann-Whitney)||||
1657331|NCT01591681|3049834|Superiority or Other|||||||0.93||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.|||
1657332|NCT01591681|3049835|Superiority or Other|||||||0.98||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.|||
1657333|NCT01591681|3049836|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.|||
1657334|NCT01591681|3049837|Superiority or Other|||||||0.1||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.|||
1657335|NCT01591681|3049838|Superiority or Other|||||||0.62||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.|||
1657336|NCT01591681|3049839|Superiority or Other|||||||0.71||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.|||
1657337|NCT01591681|3049840|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.|||
1657338|NCT01591681|3049841|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.|||
1657339|NCT01591681|3049842|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.|||
1657340|NCT01591681|3049843|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|repeated measures logistic regression|Was used to test differences using mixed effects and a within subject autocorrelation structure to account for multiple nights from the same subject.|||
1657341|NCT01591681|3049844|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance is 0.05.|Repeated measures regression model|Repeated measures regression model was used accounting for correlated data from the same participant and for the overnight measures.||Sample size was computed to be 45 participants using the system for 42 nights (21 nights with system active and 21 control nights) for a total of 1,890 nights in order to have 90% power with a type 1 error rate of 5% to reject the null hypothesis of no difference in nocturnal hypoglycemia assuming a true population rate of 30% of control nights and 15% of intervention nights with hypoglycemia after adjusting for the correlation from repeated nights and misclassification due to sensor inaccuracy.|
1657342|NCT01591382|3049896|Superiority or Other|||||||0.748|||||||Wilcoxon (Mann-Whitney)||||
1657343|NCT01591382|3049897|Superiority or Other|||||||0.1085||||||A P-value of <0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)||||
1657344|NCT01591382|3049898|Superiority or Other|||||||0.4102||||||A P-value of <0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)||||
1657345|NCT01591382|3049899|Superiority or Other|||||||0.0241||||||A P-value of <0.05 was indicative of statistical significance.|Wilcoxon (Mann-Whitney)||||
1657346|NCT01591018|3049914|Superiority or Other||||||<|0.05||||||Pre-study calculations using chi-square test with a continuity correction showed that ≥60 patients in each group were needed to reach a significant difference with an alpha value of 0.05 (two-tailed) and a beta value of 0.8.|Chi-squared, Corrected|||Sample size was based on an expected 20% reduction of new ischemic lesions on DW–MRI in the sonolysis group (estimated prevalence, 10%) compared with the control group (estimated prevalence, 30%).|
1657347|NCT01590875|3049936|Equivalence|Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|||||<|0.01|||||||kappa statistic|||Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|
1657348|NCT01590875|3049937|Equivalence|Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|||||<|0.01|||||||no relevant statistical analysis|||Kappa statistics on per pulmonary vein basis were used to determine the probability of recovery, transient recovery or no recovery with second adenosine dose compared with probability of same response after first adenosine dose|
1657349|NCT01590810|3049938|Superiority or Other||LS Mean Difference|-9.52|Standard Error of the Mean|1.45|<|0.0001|2-Sided|95.0|-12.55|-6.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657350|NCT01590810|3049938|Superiority or Other||LS Mean Difference|-8.57|Standard Error of the Mean|1.41|<|0.0001|2-Sided|95.0|-11.51|-5.64|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657351|NCT01590810|3049938|Superiority or Other||LS Mean Difference|-6.86|Standard Error of the Mean|1.38|<|0.0001|2-Sided|95.0|-9.73|-3.99|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657352|NCT01590810|3049938|Superiority or Other||LS Mean Difference|-9.12|Standard Error of the Mean|1.49|<|0.0001|2-Sided|95.0|-12.22|-6.03|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657353|NCT01590810|3049939|Superiority or Other||LS Mean Difference|-13.68|Standard Error of the Mean|4.03||0.006|2-Sided|95.0|-22.55|-4.81|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657354|NCT01590810|3049939|Superiority or Other||LS Mean Difference|-6.76|Standard Error of the Mean|4.64||0.174|2-Sided|95.0|-16.98|3.46|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657355|NCT01590810|3049939|Superiority or Other||LS Mean Difference|-1.72|Standard Error of the Mean|4.0||0.675|2-Sided|95.0|-10.54|7.09|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657356|NCT01590810|3049940|Superiority or Other||LS Mean Difference|-8.31|Standard Error of the Mean|1.45|<|0.0001|2-Sided|95.0|-11.3|-5.31|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657357|NCT01590810|3049940|Superiority or Other||LS Mean Difference|-9.79|Standard Error of the Mean|2.27|<|0.001|2-Sided|95.0|-14.49|-5.09|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657358|NCT01590810|3049940|Superiority or Other||LS Mean Difference|-7.75|Standard Error of the Mean|2.34|<|0.003|2-Sided|95.0|-12.58|-2.92|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657359|NCT01590810|3049940|Superiority or Other||LS Mean Difference|-4.32|Standard Error of the Mean|1.97|<|0.039|2-Sided|95.0|-8.4|-0.24|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657360|NCT01590810|3049940|Superiority or Other||LS Mean Difference|-2.02|Standard Error of the Mean|1.39|<|0.16|2-Sided|95.0|-4.89|0.86|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657361|NCT01590810|3049941|Superiority or Other||LS Mean Difference|-8.61|Standard Error of the Mean|1.3|<|0.0001|2-Sided|95.0|-11.28|-5.94|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657362|NCT01590810|3049941|Superiority or Other||LS Mean Difference|-5.45|Standard Error of the Mean|1.95|<|0.01|2-Sided|95.0|-9.46|-1.44|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657363|NCT01590810|3049941|Superiority or Other||LS Mean Difference|-6.77|Standard Error of the Mean|1.17|<|0.0001|2-Sided|95.0|-9.18|-4.36|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657364|NCT01590810|3049941|Superiority or Other||LS Mean Difference|-1.34|Standard Error of the Mean|0.56|<|0.023|2-Sided|95.0|-2.49|-0.2|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657365|NCT01590810|3049941|Superiority or Other||LS Mean Difference|0.31|Standard Error of the Mean|1.04|<|0.765|2-Sided|95.0|-1.82|2.45|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657526|NCT01587989|3050240|Superiority or Other|||||||0.839|||||||Wilcoxon (Mann-Whitney)|||Pain|
1657366|NCT01590810|3049942|Superiority or Other||LS Mean Difference|-7.47|Standard Error of the Mean|2.02||0.001|2-Sided|95.0|-11.69|-3.25|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657367|NCT01590810|3049942|Superiority or Other||LS Mean Difference|-8.19|Standard Error of the Mean|2.02||0.001|2-Sided|95.0|-12.4|-3.98|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657368|NCT01590810|3049942|Superiority or Other||LS Mean Difference|-7.19|Standard Error of the Mean|2.1||0.003|2-Sided|95.0|-11.57|-2.81|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657369|NCT01590810|3049942|Superiority or Other||LS Mean Difference|-9.77|Standard Error of the Mean|1.5|<|0.0001|2-Sided|95.0|-12.9|-6.65|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657370|NCT01590810|3049943|Superiority or Other||LS Mean Difference|-16.03|Standard Error of the Mean|6.29||0.027|2-Sided|95.0|-29.87|-2.19|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657371|NCT01590810|3049943|Superiority or Other||LS Mean Difference|-12.87|Standard Error of the Mean|6.62||0.078|2-Sided|95.0|-27.44|1.69|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657372|NCT01590810|3049943|Superiority or Other||LS Mean Difference|-6.93|Standard Error of the Mean|6.52||0.311|2-Sided|95.0|-21.27|7.42|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657373|NCT01590810|3049944|Superiority or Other||LS Mean Difference|-5.22|Standard Error of the Mean|1.22|<|0.001|2-Sided|95.0|-7.76|-2.69|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657374|NCT01590810|3049944|Superiority or Other||LS Mean Difference|-7.33|Standard Error of the Mean|1.73|<|0.001|2-Sided|95.0|-10.9|-3.76|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657375|NCT01590810|3049944|Superiority or Other||LS Mean Difference|-5.99|Standard Error of the Mean|1.91|<|0.005|2-Sided|95.0|-9.94|-2.04|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657376|NCT01590810|3049944|Superiority or Other||LS Mean Difference|-5.64|Standard Error of the Mean|1.35|<|0.001|2-Sided|95.0|-8.43|-2.84|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657377|NCT01590810|3049944|Superiority or Other||LS Mean Difference|-3.43|Standard Error of the Mean|1.33|<|0.017|2-Sided|95.0|-6.19|-0.67|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657378|NCT01590810|3049945|Superiority or Other||LS Mean Difference|-5.92|Standard Error of the Mean|1.13|<|0.0001|2-Sided|95.0|-8.24|-3.59|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657379|NCT01590810|3049945|Superiority or Other||LS Mean Difference|-3.37|Standard Error of the Mean|0.78|<|0.001|2-Sided|95.0|-4.98|-1.76|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657380|NCT01590810|3049945|Superiority or Other||LS Mean Difference|-4.59|Standard Error of the Mean|0.8|<|0.0001|2-Sided|95.0|-6.23|-2.94|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657381|NCT01590810|3049945|Superiority or Other||LS Mean Difference|-1.7|Standard Error of the Mean|0.53|<|0.004|2-Sided|95.0|-2.79|-0.62|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657382|NCT01590810|3049945|Superiority or Other||LS Mean Difference|-0.73|Standard Error of the Mean|1.19|<|0.547|2-Sided|95.0|-3.19|1.73|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657383|NCT01590810|3049946|Superiority or Other||LS Mean Difference|-11.13|Standard Error of the Mean|1.36|<|0.0001|2-Sided|95.0|-13.97|-8.29|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657384|NCT01590810|3049946|Superiority or Other||LS Mean Difference|-10.64|Standard Error of the Mean|1.34|<|0.0001|2-Sided|95.0|-13.44|-7.84|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657385|NCT01590810|3049946|Superiority or Other||LS Mean Difference|-8.55|Standard Error of the Mean|1.26|<|0.0001|2-Sided|95.0|-11.18|-5.91|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657386|NCT01590810|3049946|Superiority or Other||LS Mean Difference|-10.84|Standard Error of the Mean|1.42|<|0.0001|2-Sided|95.0|-13.79|-7.89|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657387|NCT01590810|3049947|Superiority or Other||LS Mean Difference|-15.51|Standard Error of the Mean|4.32||0.004|2-Sided|95.0|-25.01|-6.01|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657388|NCT01590810|3049947|Superiority or Other||LS Mean Difference|-8.18|Standard Error of the Mean|5.18||0.143|2-Sided|95.0|-19.58|3.22|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657389|NCT01590810|3049947|Superiority or Other||LS Mean Difference|-2.27|Standard Error of the Mean|4.65||0.635|2-Sided|95.0|-12.5|7.96|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657390|NCT01590810|3049948|Superiority or Other||LS Mean Difference|-9.25|Standard Error of the Mean|1.67|<|0.0001|2-Sided|95.0|-12.7|-5.8|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657391|NCT01590810|3049948|Superiority or Other||LS Mean Difference|-11.16|Standard Error of the Mean|2.65|<|0.001|2-Sided|95.0|-16.64|-5.68|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657392|NCT01590810|3049948|Superiority or Other||LS Mean Difference|-8.93|Standard Error of the Mean|2.5|<|0.002|2-Sided|95.0|-14.1|-3.76|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657393|NCT01590810|3049948|Superiority or Other||LS Mean Difference|-4.8|Standard Error of the Mean|2.27|<|0.046|2-Sided|95.0|-9.51|-0.1|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657394|NCT01590810|3049948|Superiority or Other||LS Mean Difference|-2.07|Standard Error of the Mean|1.62|<|0.216|2-Sided|95.0|-5.43|1.3|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657395|NCT01590810|3049949|Superiority or Other||LS Mean Difference|-10.31|Standard Error of the Mean|1.23|<|0.0001|2-Sided|95.0|-12.84|-7.78|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657396|NCT01590810|3049949|Superiority or Other||LS Mean Difference|-6.5|Standard Error of the Mean|1.58|<|0.001|2-Sided|95.0|-9.74|-3.25|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657397|NCT01590810|3049949|Superiority or Other||LS Mean Difference|-8.11|Standard Error of the Mean|0.96|<|0.0001|2-Sided|95.0|-10.08|-6.14|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657398|NCT01590810|3049949|Superiority or Other||LS Mean Difference|-1.75|Standard Error of the Mean|0.51|<|0.002|2-Sided|95.0|-2.79|-0.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657399|NCT01590810|3049949|Superiority or Other||LS Mean Difference|0.97|Standard Error of the Mean|1.09|<|0.383|2-Sided|95.0|-1.28|3.22|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657400|NCT01590810|3049950|Superiority or Other||LS Mean Difference|9.5|Standard Error of the Mean|4.94||0.069|2-Sided|95.0|-0.81|19.81|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657401|NCT01590810|3049950|Superiority or Other||LS Mean Difference|5.15|Standard Error of the Mean|4.6||0.276|2-Sided|95.0|-4.44|14.74|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657402|NCT01590810|3049950|Superiority or Other||LS Mean Difference|4.58|Standard Error of the Mean|5.15||0.385|2-Sided|95.0|-6.16|15.32|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657403|NCT01590810|3049950|Superiority or Other||LS Mean Difference|4.42|Standard Error of the Mean|4.98||0.385|2-Sided|95.0|-5.96|14.81|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657404|NCT01590810|3049951|Superiority or Other||LS Mean Difference|3.65|Standard Error of the Mean|2.13||0.114|2-Sided|95.0|-1.03|8.33|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657405|NCT01590810|3049951|Superiority or Other||LS Mean Difference|0.92|Standard Error of the Mean|2.07||0.664|2-Sided|95.0|-3.63|5.48|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657406|NCT01590810|3049951|Superiority or Other||LS Mean Difference|-1.45|Standard Error of the Mean|1.16||0.241|2-Sided|95.0|-4.01|1.12|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657407|NCT01590810|3049952|Superiority or Other||LS Mean Difference|4.62|Standard Error of the Mean|0.78|<|0.0001|2-Sided|95.0|3.0|6.24|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657408|NCT01590810|3049952|Superiority or Other||LS Mean Difference|2.61|Standard Error of the Mean|0.61|<|0.001|2-Sided|95.0|1.34|3.88|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657409|NCT01590810|3049952|Superiority or Other||LS Mean Difference|0.09|Standard Error of the Mean|1.52|<|0.951|2-Sided|95.0|-3.04|3.23|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657410|NCT01590810|3049952|Superiority or Other||LS Mean Difference|-1.48|Standard Error of the Mean|1.05|<|0.175|2-Sided|95.0|-3.65|0.7|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657411|NCT01590810|3049952|Superiority or Other||LS Mean Difference|-0.83|Standard Error of the Mean|1.39|<|0.557|2-Sided|95.0|-3.7|2.05|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657412|NCT01590810|3049953|Superiority or Other||LS Mean Difference|2.15|Standard Error of the Mean|0.74||0.008|2-Sided|95.0|0.63|3.67|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657413|NCT01590810|3049953|Superiority or Other||LS Mean Difference|5.64|Standard Error of the Mean|1.22|<|0.0001|2-Sided|95.0|3.14|8.15|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657414|NCT01590810|3049953|Superiority or Other||LS Mean Difference|2.18|Standard Error of the Mean|0.55|<|0.001|2-Sided|95.0|1.04|3.32|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657415|NCT01590810|3049953|Superiority or Other||LS Mean Difference|2.18|Standard Error of the Mean|1.18|<|0.076|2-Sided|95.0|-0.25|4.61|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657416|NCT01590810|3049953|Superiority or Other||LS Mean Difference|1.05|Standard Error of the Mean|0.75|<|0.175|2-Sided|95.0|-0.5|2.6|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657417|NCT01590810|3049954|Superiority or Other||LS Mean Difference|-12.96|Standard Error of the Mean|1.38|<|0.0001|2-Sided|95.0|-15.85|-10.08|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657418|NCT01590810|3049954|Superiority or Other||LS Mean Difference|-13.63|Standard Error of the Mean|1.2|<|0.0001|2-Sided|95.0|-16.12|-11.13|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657419|NCT01590810|3049954|Superiority or Other||LS Mean Difference|-10.58|Standard Error of the Mean|1.51|<|0.0001|2-Sided|95.0|-13.74|-7.42|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657420|NCT01590810|3049954|Superiority or Other||LS Mean Difference|-12.36|Standard Error of the Mean|1.56|<|0.0001|2-Sided|95.0|-15.62|-9.11|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657421|NCT01590810|3049955|Superiority or Other||LS Mean Difference|-14.3|Standard Error of the Mean|2.45|<|0.001|2-Sided|95.0|-19.69|-8.91|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657422|NCT01590810|3049955|Superiority or Other||LS Mean Difference|-5.36|Standard Error of the Mean|3.12|<|0.113|2-Sided|95.0|-12.23|1.5|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657423|NCT01590810|3049955|Superiority or Other||LS Mean Difference|-1.59|Standard Error of the Mean|2.51|<|0.539|2-Sided|95.0|-7.12|3.93|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657424|NCT01590810|3049956|Superiority or Other||LS Mean Difference|-16.24|Standard Error of the Mean|1.96|<|0.0001|2-Sided|95.0|-20.29|-12.19|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657425|NCT01590810|3049956|Superiority or Other||LS Mean Difference|-18.33|Standard Error of the Mean|1.76|<|0.0001|2-Sided|95.0|-21.98|-14.68|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657426|NCT01590810|3049956|Superiority or Other||LS Mean Difference|-13.48|Standard Error of the Mean|3.16|<|0.001|2-Sided|95.0|-20.03|-6.93|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657427|NCT01590810|3049956|Superiority or Other||LS Mean Difference|-6.76|Standard Error of the Mean|2.19|<|0.005|2-Sided|95.0|-11.29|-2.22|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657428|NCT01590810|3049956|Superiority or Other||LS Mean Difference|-2.95|Standard Error of the Mean|1.26|<|0.029|2-Sided|95.0|-5.56|-0.34|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657429|NCT01590810|3049957|Superiority or Other||LS Mean Difference|-16.78|Standard Error of the Mean|1.96|<|0.0001|2-Sided|95.0|-20.81|-12.75|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657430|NCT01590810|3049957|Superiority or Other||LS Mean Difference|-8.15|Standard Error of the Mean|1.55|<|0.0001|2-Sided|95.0|-11.34|-4.96|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657431|NCT01590810|3049957|Superiority or Other||LS Mean Difference|-11.62|Standard Error of the Mean|1.36|<|0.0001|2-Sided|95.0|-14.42|-8.82|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657432|NCT01590810|3049957|Superiority or Other||LS Mean Difference|-2.23|Standard Error of the Mean|0.86|<|0.016|2-Sided|95.0|-4.0|-0.45|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657433|NCT01590810|3049957|Superiority or Other||LS Mean Difference|-2.31|Standard Error of the Mean|1.18|<|0.061|2-Sided|95.0|-4.73|0.11|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657434|NCT01590810|3049958|Superiority or Other||LS Mean Difference|-12.84|Standard Error of the Mean|1.75|<|0.0001|2-Sided|95.0|-16.49|-9.19|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657435|NCT01590810|3049958|Superiority or Other||LS Mean Difference|-12.82|Standard Error of the Mean|1.74|<|0.0001|2-Sided|95.0|-16.45|-9.19|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657436|NCT01590810|3049958|Superiority or Other||LS Mean Difference|-10.2|Standard Error of the Mean|1.8|<|0.0001|2-Sided|95.0|-13.94|-6.45|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657437|NCT01590810|3049958|Superiority or Other||LS Mean Difference|-13.21|Standard Error of the Mean|1.74|<|0.0001|2-Sided|95.0|-16.84|-9.59|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657438|NCT01590810|3049959|Superiority or Other||LS Mean Difference|-17.51|Standard Error of the Mean|5.15||0.006|2-Sided|95.0|-28.85|-6.18|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657439|NCT01590810|3049959|Superiority or Other||LS Mean Difference|-10.79|Standard Error of the Mean|5.72||0.086|2-Sided|95.0|-23.37|1.79|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657440|NCT01590810|3049959|Superiority or Other||LS Mean Difference|-4.1|Standard Error of the Mean|5.61||0.48|2-Sided|95.0|-16.44|8.25|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657441|NCT01590810|3049960|Superiority or Other||LS Mean Difference|-9.73|Standard Error of the Mean|1.55|<|0.0001|2-Sided|95.0|-12.93|-6.53|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657442|NCT01590810|3049960|Superiority or Other||LS Mean Difference|-12.02|Standard Error of the Mean|2.17|<|0.0001|2-Sided|95.0|-16.51|-7.52|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657443|NCT01590810|3049960|Superiority or Other||LS Mean Difference|-9.49|Standard Error of the Mean|2.27|<|0.001|2-Sided|95.0|-14.2|-4.79|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657444|NCT01590810|3049960|Superiority or Other||LS Mean Difference|-5.46|Standard Error of the Mean|1.95|<|0.01|2-Sided|95.0|-9.49|-1.43|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657445|NCT01590810|3049960|Superiority or Other||LS Mean Difference|-2.89|Standard Error of the Mean|1.4|<|0.052|2-Sided|95.0|-5.79|0.02|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657446|NCT01590810|3049961|Superiority or Other||LS Mean Difference|-10.41|Standard Error of the Mean|1.21|<|0.0001|2-Sided|95.0|-12.89|-7.92|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657447|NCT01590810|3049961|Superiority or Other||LS Mean Difference|-6.84|Standard Error of the Mean|1.1|<|0.0001|2-Sided|95.0|-9.1|-4.58|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657448|NCT01590810|3049961|Superiority or Other||LS Mean Difference|-8.23|Standard Error of the Mean|0.92|<|0.0001|2-Sided|95.0|-10.13|-6.34|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657449|NCT01590810|3049961|Superiority or Other||LS Mean Difference|-2.2|Standard Error of the Mean|0.32|<|0.0001|2-Sided|95.0|-2.86|-1.55|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657450|NCT01590810|3049961|Superiority or Other||Least Squares (LS) Mean Difference|0.78|Standard Error of the Mean|1.15|<|0.503|2-Sided|95.0|-1.59|3.15|||Mixed Models Analysis||Difference is MK-8150 dose – placebo||
1657451|NCT01590797|3049966|Superiority or Other||Mean Difference (Final Values)|-26.5|||<|0.001|2-Sided|95.0|-38.4|-14.7|||ANCOVA|ANCOVA model with terms for treatment and the metformin stratum and type of insulin, and baseline 2-hr Post- Meal Glucose (mg/dL) as a covariate.|||
1657452|NCT01590797|3049967|Superiority or Other||Mean Difference (Final Values)|-0.38||||0.002|2-Sided|95.0|-0.61|-0.14|||Robust Regression|Robust regression using M-estimation with terms for treatment and type of insulin, and baseline A1C (%) as a covariate.|||
1657453|NCT01590797|3049968|Superiority or Other||Mean Difference (Final Values)|-0.34|||<|0.001|2-Sided|95.0|-0.5|-0.19|||Robust Regression|Robust regression using M-estimation with terms for treatment and the metformin stratum and type of insulin, and baseline A1C (%) as a covariate.|||
1657454|NCT01590771|3049971|Superiority or Other||Estimate Difference|-17.0|||<|0.001|2-Sided|95.0|-26.9|-7.1||Based on robust regression using M-estimation with terms for treatment and baseline FPG value.|Robust Regression||||
1657455|NCT01590771|3049972|Superiority or Other||Estimate Difference|-16.5|||<|0.001|2-Sided|95.0|-25.3|-7.8||Based on robust regression using M-estimation with terms for treatment and baseline FPG value.|Robust Regression||||
1657456|NCT01590771|3049973|Superiority or Other||Difference in least squares mean|-37.7|||<|0.001|2-Sided|95.0|-56.9|-18.4||The ANCOVA model controlled for treatment and baseline 2-hr PMG value.|ANCOVA||||
1657457|NCT01590771|3049974|Superiority or Other||Estimate difference|-27.2|||<|0.001|2-Sided|95.0|-41.2|-13.2||Based on robust regression using M-estimation with terms for treatment and baseline 2-hr PMG value.|Robust regression||||
1657458|NCT01590771|3049975|Superiority or Other||Difference in least squares mean|-0.8|||<|0.001|2-Sided|95.0|-1.07|-0.53||The ANCOVA model controlled for treatment and baseline A1C value.|ANCOVA||||
1657459|NCT01590771|3049976|Superiority or Other||Difference in least squares mean|-0.41|||<|0.001|2-Sided|95.0|-0.63|-0.2||The ANCOVA model controlled for treatment and baseline A1C value.|ANCOVA||||
1657460|NCT01590771|3049977|Superiority or Other||Estimate difference|-16.8|||<|0.001|2-Sided|95.0|-23.3|-10.2||Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline FPG value.|Robust regression||||
1657461|NCT01590771|3049978|Superiority or Other||Difference in least squares mean|-32.9|||<|0.001|2-Sided|95.0|-45.4|-20.4||The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline 2-hr PMG value.|ANCOVA||||
1657462|NCT01590771|3049979|Superiority or Other||Robust regression|-0.61|||<|0.001|2-Sided|95.0|-0.77|-0.44||The ANCOVA model controlled for treatment, metformin strata (on or not on metformin), and baseline A1C value.|ANCOVA||Based on robust regression using M-estimation with terms for treatment, metformin strata (on or not on metformin), and baseline A1C value.||
1657463|NCT01590433|3049989|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1657491|NCT01589445|3050093|Superiority or Other||Mean Difference (Net)|-10.62|Standard Deviation|32.05|<|0.21|2-Sided|95.0|-113.8|76.2||Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||LDL|
1657527|NCT01587989|3050240|Superiority or Other|||||||0.655|||||||Wilcoxon (Mann-Whitney)|||Fatigue|
1657464|NCT01589978|3050000|Non-Inferiority or Equivalence|The sample size is calculated for one-sample chi-square test for a single proportion using nQuery AdvisorVersion 5.0. The expected annual increase in ST rate is estimated to be 0.4% based on the current data available from the pooled TAXUS Express and pooled TAXUS Liberté data and the PG is 1.0% using a delta of 0.6%. Given a one-sided 5% significance level, a minimum of 1,660 PLATINUM-like patients at 5-yrs will be required to provide 90% power to reject the null hypothesis if it is false.|||||<|0.0001|||||||Chi-squared|||The expected annual increase of stent thrombosis rate is assumed to be 0.4%, based on the observed increase in incidence rate of stent thrombosis of approximately 0.4% annually for PLATINUM-like patients in the pooled TAXUS SR Express and pooled TAXUS Liberté data. Using a delta of 0.6%, the performance goal is set to 1.0% (expected rate + delta = 0.4% + 0.6% = 1.0%).|
1657465|NCT01589978|3050020|Non-Inferiority or Equivalence|Given the performance goal of 3.2%, with expected rate for PROMUS Element Plus of 2.2% and a one-sided 5% significance level, approximately 1,706 PLATINUM-like patients will provide at least 80% power to reject the null hypothesis if it is false.|||||<|0.0001|||||||Chi-squared|||One-sided, single binomial test will be performed to compare observed rate against performance goal, the normal approximation of the test statistic will be used. The performance goal is met if the one-sided upper 95% confidence bound for the observed binary rate is less than performance goal.|
1657466|NCT01589653|3050038|Non-Inferiority or Equivalence|Non-inferiority was to be considered confirmed if the upper bound of the two-sided 95% CI was below or equal to 0.4% or equivalently when the p-value for the one-sided test of H0: D > 0.4% against HA: D ≤ 0.4%, was less than or equal to 2.5%, where D is the mean treatment difference (subject-driven titration minus investigator-driven titration).|Treatment difference|-0.23|||<|0.001|2-Sided|95.0|-0.54|0.08|||Regression, Linear|Analyses were adjusted for treatment, strata, country and baseline HbA1c||The null-hypothesis was tested against the alternative hypothesis of non-inferiority as given by: H0: D > 0.4% against HA: D ≤ 0.4% where D is the mean treatment difference for change in HbA1c (subject-driven titration minus investigator-driven titration).|
1657467|NCT01589601|3050039|Superiority|Non-cardiovascular readmissions, Poisson regression with log link and Pearson scale||||||0.12|||||||Poisson regression||||
1657468|NCT01589601|3050039|Superiority|Heart failure readmissions, Poisson regression with log link and Pearson scale||||||0.92|||||||Poisson regression||||
1657469|NCT01589601|3050039|Superiority|Cardiovascular readmissions, Poisson regression with log link and Pearson scale||||||0.8|||||||Poisson regression||||
1657470|NCT01589601|3050039|Superiority|All-cause readmissions, Poisson regression with log link and Pearson scale||||||0.56|||||||Poisson regression||||
1657471|NCT01589601|3050041|Superiority|FACIT-Sp at 6 months|Mean Difference (Net)|3.9809||||0.0271|2-Sided|95.0|0.4581|7.5036|||Mixed Models Analysis||||
1657472|NCT01589601|3050041|Superiority|FACIT-Sp at 3 months|Mean Difference (Net)|1.1174||||0.5655|2-Sided|95.0|-2.7246|4.9594|||Mixed Models Analysis||||
1657473|NCT01589601|3050041|Superiority|FACIT-Sp at 2 weeks|Mean Difference (Net)|0.9413||||0.5857|2-Sided|95.0|-2.4666|4.3493|||Mixed Models Analysis||||
1657474|NCT01589601|3050043|Superiority|HADS Depression at 6 months|Mean Difference (Net)|-1.9379||||0.0202|2-Sided|95.0|-3.5672|-0.3085|||Mixed Models Analysis||||
1657475|NCT01589601|3050043|Superiority|HADS Depression 3 months|Mean Difference (Net)|-0.6592||||0.4237|2-Sided|95.0|-2.2862|0.9678|||Mixed Models Analysis||||
1657476|NCT01589601|3050043|Superiority|HADS Depression at 2 weeks|Mean Difference (Net)|-0.9097||||0.2372|2-Sided|95.0|-2.4253|0.6058|||Mixed Models Analysis||||
1657477|NCT01589601|3050043|Superiority|HADS Anxiety 6 months|Mean Difference (Net)|-1.8269||||0.048|2-Sided|95.0|-3.6375|-0.0164|||Mixed Models Analysis||||
1657478|NCT01589601|3050043|Superiority|HADS Anxiety 3 months|Mean Difference (Net)|-0.7946||||0.3657|2-Sided|95.0|-2.5285|0.9393|||Mixed Models Analysis||||
1657479|NCT01589601|3050043|Superiority|HADS Anxiety 2 weeks|Mean Difference (Net)|-1.2436||||0.1592|2-Sided|95.0|-2.9817|0.4945|||Mixed Models Analysis||||
1657480|NCT01589601|3050044|Superiority||Mean Difference (Net)|11.773||||0.035|2-Sided|95.0|0.8409|22.7052|||Mixed Models Analysis|6 Months|||
1657481|NCT01589601|3050044|Superiority||Mean Difference (Net)|2.7157||||0.5531|2-Sided|95.0|-6.3054|11.7368|||Mixed Models Analysis|Baseline|||
1657482|NCT01589601|3050045|Superiority|6 Months|Mean Difference (Net)|9.4938||||0.0299|2-Sided|95.0|0.9406|18.047|||Mixed Models Analysis||||
1657483|NCT01589601|3050045|Superiority||Mean Difference (Net)|4.8719||||0.1641|2-Sided|95.0|-2.0289|11.7728|||Mixed Models Analysis|Baseline|||
1657484|NCT01589445|3050088|Superiority or Other||Mean Difference (Net)|-2.09|Standard Deviation|10.2|<|0.039|2-Sided|95.0|-27.04|26.52||Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||FSI|
1657485|NCT01589445|3050089|Superiority or Other||Mean Difference (Net)|7.53|Standard Deviation|54.0|<|0.025|2-Sided|95.0|-148.7|180.0||Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA S|
1657486|NCT01589445|3050089|Superiority or Other||Mean Difference (Net)|9.79|Standard Deviation|84.46|<|0.808|2-Sided|95.0|-346.4|328.1||Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA B|
1657487|NCT01589445|3050090|Superiority or Other||Mean Difference (Net)|-1.04|Standard Deviation|4.25|<|0.004|2-Sided|95.0|-14.12|15.52||Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HOMA IR|
1657488|NCT01589445|3050090|Superiority or Other||Mean Difference (Net)|0.02|Standard Deviation|0.12|<|0.001|2-Sided|95.0|-0.4|0.27||Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA||||
1657489|NCT01589445|3050091|Superiority or Other||Mean Difference (Net)|-0.64|Standard Deviation|1.07|>|0.05|2-Sided|95.0|-4.4|2.4||Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA||||
1657490|NCT01589445|3050092|Superiority or Other||Mean Difference (Net)|-0.74|Standard Deviation|2.41|<|0.05|2-Sided|95.0|-7.9|8.0||Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, Multiple Logistic Regression (MLR), OR, Pearson Correlation)|ANOVA||The group 001 was divided according to Pro12Pro and Pro12Ala groups.There was no Ala12Ala group.These two groups were compared also in accordance with all parameters (glycemic levels, insulin levels, lipid profiles, BMI).|Change from Baseline in FSG at 3rd month|
1657523|NCT01587989|3050239|Superiority or Other|||||||0.421|||||||Wilcoxon (Mann-Whitney)|||Convenience|
1657492|NCT01589445|3050093|Superiority or Other||Mean Difference (Net)|-0.47|Standard Deviation|9.59|<|0.322|2-Sided|95.0|-35.0|19.0||Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||HDL|
1657493|NCT01589445|3050093|Superiority or Other||Mean Difference (Net)|10.66|Standard Deviation|143.22|<|0.913|2-Sided|95.0|-397.0|976.0||Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||TG|
1657494|NCT01589445|3050093|Superiority or Other||Mean Difference (Net)|-9.06|Standard Deviation|39.47|<|0.161||95.0|-88.0|118.0||Category: Univariate & Multivariate analysis. (ANOVA, Pair t tests, MLR, OR, Pearson Correlation)|ANOVA|||TC|
1657495|NCT01589185|3050123|Superiority|||||||0.3962||||||< 0.1 is considered borderline significant|Fisher Exact|||The number (%) of patients who died on or before end of study (EOS) was compared among all 5 groups. The mITT population was used.|
1657496|NCT01588990|3050135|Superiority or Other|||||||0.016|||||||Cox Proportional Hazards Model||||
1657497|NCT01588990|3050136|Superiority or Other|||||||0.188|||||||Cox Proportional Hazards Model||||
1657498|NCT01588990|3050137|Superiority or Other|||||||0.797|||||||Cox Proportional Hazards Model||||
1657499|NCT01588990|3050138|Superiority or Other|||||||0.052|||||||Cox Proportional Hazards Model||||
1657500|NCT01588990|3050150|Superiority or Other|||||||0.101|||||||Cox Proportional Hazards Model||||
1657501|NCT01588561|3050160|Other||||||||||||||||||Increased signal: Insula (bilateral), Cingulate, Pretcentralgyrus, Thalamus (bilateral), Putamen (bilateral), Pallidum (bilateral), Amygdala (bilateral), Ventral tegmental area, Accumbens Nuclei. Decreased signal: Insula (left inferior), OBF cortex, Frontal&Temporal poles, Hippocampus (bilateral), Parahippocampus (bilateral), Accumbens nuclei, Cerebellum
1657502|NCT01588561|3050161|Other||||||||||||||||||Increased signal: Insula, Putamen, Pallidum, Cingulate, Thalamus, Operculum, OBF cortex, Lingual gyrus, Cerebellum. Decreased signal: Hippocampus (left), Parahippocampus (left), Caudate, Cerebellum
1657503|NCT01588561|3050162|Other||||||||||||||||||Increased signal: Insula, Putamen, Cingulate, Paracingulate, Calcarine cortex, Lingual gyrus, Frontal pole, Fusiform gyrus, Cerebellum. Decreased signal:Thalamus, Temporal gyri, Hippocampus (left), Caudate, Cerebellum
1657504|NCT01588509|3050170|Superiority||Percent Change from Baseline|1.4|||<|0.001|2-Sided|90.0|0.84|1.96|||ANOVA||||
1657505|NCT01588509|3050170|Superiority||Percent Change from Baseline|1.38|||<|0.001|2-Sided|90.0|0.81|1.95|||ANOVA||||
1657506|NCT01588509|3050171|Superiority||Percent Change from Baseline|1.92||||0.002|2-Sided|90.0|0.95|2.89|||ANOVA||||
1657507|NCT01588509|3050171|Superiority||Percent Change from Baseline|2.06|||<|0.001|2-Sided|90.0|1.07|3.05|||ANOVA||||
1657508|NCT01588509|3050172|Superiority||Percent Change from Baseline|2.08||||0.002|2-Sided|90.0|1.02|3.14|||ANOVA||||
1657509|NCT01588509|3050172|Superiority||Percent Change from Baseline|2.13||||0.002|2-Sided|90.0|1.05|3.2|||ANOVA||||
1657510|NCT01588496|3050173|Superiority or Other||LS Mean Treatment Difference|-30.93|Standard Error of the Mean|6.42|<|0.001|2-Sided|95.0|-43.86|-18.0||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference|LDL-C lowering was analyzed by comparing evolocumab and placebo. Statistical analysis was 2-sided with a significance level of 0.05.|
1657511|NCT01588496|3050174|Superiority or Other||LS Mean Treatment Difference|-11.27|Standard Error of the Mean|5.86||0.088|2-Sided|95.0|-23.11|0.56||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects|Model includes treatment group, baseline LDL-C level (< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1657512|NCT01588496|3050175|Superiority or Other||LS Mean Treatment Difference|-11.83|Standard Error of the Mean|6.77||0.088|2-Sided|95.0|-25.48|1.82||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1657513|NCT01588496|3050176|Superiority or Other||LS Mean Treatment Difference|-22.89|Standard Error of the Mean|5.38|<|0.001|2-Sided|95.0|-33.72|-12.05||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1657514|NCT01588496|3050177|Superiority or Other||LS Mean Treatment Difference|-23.14|Standard Error of the Mean|5.81|<|0.001|2-Sided|95.0|-34.83|-11.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1657515|NCT01588496|3050178|Superiority or Other||LS Mean Treatment Difference|-29.78|Standard Error of the Mean|5.54|<|0.001|2-Sided|95.0|-40.94|-18.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|Repeated measures linear effects model|Model includes treatment group, baseline LDL-C level (< 420 vs ≥ 420 mg/dL), scheduled visit and the interaction of treatment with scheduled visit.|Placebo is the reference||
1657516|NCT01588470|3050187|Superiority||Mean Difference (Final Values)|-1.1|||<|0.05|2-Sided||||||ANOVA||||
1657517|NCT01588470|3050189|Superiority||||||<|0.01|||||||ANOVA||||
1657518|NCT01588236|3050222|Superiority or Other||||||<|0.05||||||p value for comparison between overall drug group vs placebo, and between low dose vs placebo|Mixed Models Analysis||||
1657519|NCT01588236|3050223|Superiority or Other||||||<|0.01||||||p value for comparison between overall drug group vs placebo, and between high dose vs placebo|Mixed Models Analysis||||
1657520|NCT01588236|3050224|Superiority or Other||||||>|0.05|||||||Mixed Models Analysis|||p value for multiple comparison among 3 arms and comparison between investigational drug and placebo|
1657521|NCT01588236|3050225|Superiority or Other||||||>|0.05||||||p value for multiple comparison among 3 arms and comparison between investigational drug and placebo|Mixed Models Analysis||||
1657522|NCT01587989|3050239|Superiority or Other|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||Global satisfaction|
1657528|NCT01587989|3050241|Superiority or Other|||||||0.112|||||||Wilcoxon (Mann-Whitney)|||Mental standardized value|
1657529|NCT01587989|3050241|Superiority or Other|||||||0.417|||||||Wilcoxon (Mann-Whitney)|||Physical standardized value|
1657530|NCT01587989|3050242|Superiority or Other|||||||0.842|||||||Wilcoxon (Mann-Whitney)||||
1657531|NCT01587989|3050243|Superiority or Other|||||||0.084|||||||Fisher Exact||||
1657532|NCT01587989|3050244|Superiority or Other|||||||0.453|||||||Fisher Exact||||
1657533|NCT01587989|3050245|Superiority or Other|||||||0.207|||||||Fisher Exact||||
1657534|NCT01587989|3050246|Superiority or Other|||||||0.732|||||||Fisher Exact||||
1657535|NCT01587989|3050247|Superiority or Other|||||||0.304|||||||ANCOVA|||Adjusted change in DAS28 score from Weeks 12-24.|
1657536|NCT01587989|3050247|Superiority or Other|||||||0.015|||||||ANCOVA|||At Week 12.|
1657537|NCT01587989|3050247|Superiority or Other||Mean Difference (Final Values)|0.327||||0.188|2-Sided|95.0|-0.165|0.82|||t-test, 2 sided||||
1657538|NCT01587950|3050249|Superiority or Other||Adjusted Mean Difference|-1.07||||0.8703|2-Sided|95.0|-14.11|11.97|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657539|NCT01587950|3050249|Superiority or Other||Adjusted Mean Difference|6.68||||0.3581|2-Sided|95.0|-7.75|21.12|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657540|NCT01587950|3050249|Superiority or Other||Adjusted Mean Difference|7.75||||0.2784|2-Sided|95.0|-6.42|21.93|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657541|NCT01587950|3050249|Superiority or Other||Adjusted Mean Difference|1.66||||0.7994|2-Sided|95.0|-11.32|14.64|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05|
1657542|NCT01587950|3050249|Superiority or Other||Slope|-4.02||||0.5796|2-Sided|95.0|-18.46|10.41|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657543|NCT01587950|3050249|Superiority or Other||Adjusted Mean Difference|-5.68||||0.4374|2-Sided|95.0|-20.2|8.84|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657544|NCT01587950|3050249|Superiority or Other||Adjusted Mean Difference|-4.36||||0.5044||95.0|-17.35|8.63|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657545|NCT01587950|3050249|Superiority or Other||Adjusted Mean Difference|-6.32||||0.3811|2-Sided|95.0|-20.64|8.0|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657546|NCT01587950|3050249|Superiority or Other||Adjusted Mean Difference|-1.96||||0.7769||95.0|-15.71|11.8||ANCOVA with factors for treatment group, application site, period and random effect for subject.|ANCOVA||Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 20 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657547|NCT01587950|3050250|Superiority or Other||Adjusted Mean Difference|-5.56||||0.4255|2-Sided|95.0|-19.42|8.29|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657548|NCT01587950|3050250|Superiority or Other||Adjusted Mean Difference|5.45||||0.4798|2-Sided|95.0|-9.86|20.76|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657549|NCT01587950|3050250|Superiority or Other||Adjusted Mean Difference|11.01||||0.1493|2-Sided|95.0|-4.06|26.08|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, at 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657550|NCT01587950|3050250|Superiority or Other||Adjusted Mean Difference|-1.25||||0.8567|2-Sided|95.0|-14.98|12.49|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657551|NCT01587950|3050250|Superiority or Other||Adjusted Mean Difference|-11.12||||0.1518|2-Sided|95.0|-26.43|4.19|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657552|NCT01587950|3050250|Superiority or Other||Adjusted Mean Difference|-9.87||||0.2038|2-Sided|95.0|-25.23|5.49|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within the treatments was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657553|NCT01587950|3050250|Superiority or Other||Adjusted Mean Difference|-4.83||||0.4874|2-Sided|95.0|-18.66|8.99|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657554|NCT01587950|3050250|Superiority or Other||Adjusted Mean Difference|-11.22||||0.1448|2-Sided|95.0|-26.41|3.96|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657555|NCT01587950|3050250|Superiority or Other||Adjusted Mean Difference|-6.39||||0.3867|2-Sided|95.0|-21.04|8.26|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero, 10 minutes post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657556|NCT01587950|3050251|Superiority or Other||Adjusted Mean Difference|-2.72||||0.6931|2-Sided|95.0|-16.44|10.99|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657557|NCT01587950|3050251|Superiority or Other||Adjusted Mean Difference|6.24||||0.4138|2-Sided|95.0|-8.92|21.39|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657558|NCT01587950|3050251|Superiority or Other||Adjusted Mean Difference|8.96||||0.2346|2-Sided|95.0|-5.96|23.88|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657559|NCT01587950|3050251|Superiority or Other||Adjusted Mean Difference|-6.39||||0.3513|2-Sided|95.0|-19.98|7.2|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657560|NCT01587950|3050251|Superiority or Other||Adjusted Mean Difference|-3.02||||0.6921|2-Sided|95.0|-18.17|12.13|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657561|NCT01587950|3050251|Superiority or Other||Adjusted Mean Difference|3.37||||0.6591|2-Sided|95.0|-11.82|18.56|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657562|NCT01587950|3050251|Superiority or Other||Adjusted Mean Difference|-3.89||||0.5718|2-Sided|95.0|-17.59|9.8|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657563|NCT01587950|3050251|Superiority or Other||Adjusted Mean Difference|-4.89||||0.5183|2-Sided|95.0|-19.91|10.14|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657564|NCT01587950|3050251|Superiority or Other||Adjusted Mean Difference|-0.99||||0.8918|2-Sided|95.0|-15.5|13.52|||ANCOVA|ANCOVA with factors for treatment group, application site, period and random effect for subject|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis suggested that mean change from baseline in the evaporative sensitivity within each of the treatment was zero immediately post treatment. Statistical tests were 2-sided with a significance level of 0.05.|
1657565|NCT01587924|3050274|Superiority or Other|||||||0.8537||||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline region as the US and Canada versus modeled Hgb change from baseline in participants with Baseline region as not the US and Canada|
1657566|NCT01587924|3050274|Superiority or Other|||||||0.2044||||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline diabetes presence versus modeled Hgb change from baseline in participants with no Baseline diabetes|
1657567|NCT01587924|3050274|Superiority or Other|||||||0.0622||||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline co-ad with food versus modeled Hgb change from baseline in participants with Baseline co-ad without food|
1657568|NCT01587924|3050274|Superiority or Other|||||||0.7865||||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline age <65 years versus modeled Hgb change from baseline in participants with Baseline age >=65 years|
1657569|NCT01587924|3050274|Superiority or Other|||||||0.7495||||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline gender as male versus modeled Hgb change from baseline in participants with Baseline gender female|
1657570|NCT01587924|3050274|Superiority or Other|||||||0.0618||||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline geographic ancestry as African American versus modeled Hgb change from baseline in participants with no geographic ancestry as African American|
1657571|NCT01587924|3050274|Superiority or Other|||||||0.977||||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with ethnicity non-Hispanic or Latino versus modeled Hgb change from baseline in participants with ethnicity non-Hispanic or Latino|
1657572|NCT01587924|3050274|Superiority or Other|||||||0.5082||||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline weight <= 80.5 Kg versus modeled Hgb change from baseline in participants with Baseline weight > 80.5|
1657573|NCT01587924|3050274|Superiority or Other|||||||0.0135||||||The p-value is showing the interaction of each subgroup by treatment and by day|Regression, Linear|||Modeled Hgb change from baseline in participants with Baseline Hgb <10.80 versus modeled Hgb change from baseline in participants with Baseline Hgb >= 10.80|
1657574|NCT01587898|3050317|Superiority or Other|||||||0.2194|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Region|
1657575|NCT01587898|3050317|Superiority or Other|||||||0.0021|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Diabetic|
1657576|NCT01587898|3050317|Superiority or Other|||||||0.0085|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Co-administration with food|
1657577|NCT01587898|3050317|Superiority or Other|||||||0.5536|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Age|
1657578|NCT01587898|3050317|Superiority or Other|||||||0.7002|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Sex|
1657579|NCT01587898|3050317|Superiority or Other|||||||0.9996|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Geographic Ancestry|
1657580|NCT01587898|3050317|Superiority or Other|||||||0.2092|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Covariate: Ethnicity|
1657581|NCT01587898|3050317|Superiority or Other|||||||0.7999|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline estimated glomerular filtration rate (eGFR)|
1657582|NCT01587898|3050317|Superiority or Other|||||||0.66|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline Weight|
1657614|NCT01585038|3050740|Superiority or Other||Mean Difference (Net)|6.7||||0.41|2-Sided|95.0|-62.49|75.89|||t-test, 2 sided||||
1657583|NCT01587898|3050317|Superiority or Other|||||||0.5888|||||||Mixed effects linear regression model|The modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model.||Subgroup: Baseline Hgb|
1657584|NCT01587885|3050323|Superiority or Other||Hazard Ratio (HR)|1.548|||<|0.048|||||||Regression, Cox||||
1657585|NCT01587651|3050409|Non-Inferiority or Equivalence|Noninferiority was assessed using a 95% CI of the difference in mean PRU between ticagrelor and prasugrel (2 arms combined). Under the assumption of 0 difference in mean PRU between prasugrel 10 mg QD MD and ticagrelor 90 mg BID MD, a common SD of 60 PRU (based on previous DSI studies and published data), and a drop-out rate not exceeding 15%, a sample size of 105 allows for the 95% CI to stay within ± 45 PRU (non-inferiority margin) with a power of 90%.|Mean Difference (Final Values)|46.0|Standard Error of the Mean|10.66|||2-Sided|95.0|24.9|67.2||||||ANCOVA model included treatment as a main effect and pre-randomization baseline PRU as a covariate. The combined prasugrel groups were modeled as a single treatment. If the upper limit of the CI for the mean difference was not greater than 45 PRU, then the PD response to prasugrel 10 mg QD MD was deemed noninferior to that achieved by ticagrelor 90 mg BID MD.|
1657586|NCT01587118|3050411|Superiority or Other|||||||0.0006||||||The a priori threshold for statistical significance was p</= 0.05|ANOVA|Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.|||
1657587|NCT01587118|3050412|Superiority or Other||||||<|0.0001||||||The a priori threshold for statistical significance was p</= 0.05|ANOVA|Change from baseline analyses were conducted using simple one-way analysis of variance; and were recalculated using the Kruskal Wallis procedure.|||
1657588|NCT01586975|3050441|Superiority or Other|||||||0.0742||||||p-value is not adjusted, and no a priori threshold was used|Kruskal-Wallis|||Kruskal-Wallis non-parametric ANOVA test|
1657589|NCT01586910|3050470|Non-Inferiority|Non-inferiority margin was 0.07. Posterior threshold for non-inferiority was 0.971|Posterior Median of the Difference|-1.4|||||2-Sided||||||||95% Bayesian credible interval for the difference (TAVR-SAVR) was (-5.2%, 2.3%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.|Primary Hypothesis: TAVR with the Medtronic TAVR is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months.|
1657590|NCT01586819|3050476|Superiority||Z score|3.6115||||0.001|2-Sided||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have higher difference scores, pre- to post-treatment, on the facial wrinkle severity scale suggesting a more pronounced effect of the chemical peel in combination with the Botox A therapy.|
1657591|NCT01586819|3050477|Superiority||Z score|-3.3902||||0.002|2-Sided||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that subjects receiving Botox A as an added pre-treatment would have lower scores on the facial wrinkle severity scale post-treatment.|
1657592|NCT01586338|3050539|Superiority or Other||||||<|0.0001|||||||Sign Rank Test||||
1657593|NCT01586338|3050539|Superiority or Other||||||<|0.0001||||||Threshold for significance = 0.05.|Paired t-test||||
1657594|NCT01586156|3050551|Non-Inferiority|Carvedilol did not lead to worse cardiac output as compared to placebo.||||||0.8|||||||ANOVA||||
1657595|NCT01586156|3050552|Other||||||>|0.05|||||||ANOVA||||
1657596|NCT01586156|3050554|Superiority|||||||0.05|||||||ANOVA||||
1657597|NCT01586156|3050555|Other|Pearson's correlation test of association of alprenolol binding changes to dose carvedilol.||||||0.02||||||Correlation of the change in alprenolol binding relative to dose carvedilol.|Pearson||||
1657598|NCT01586156|3050556|Superiority|||||||0.04|||||||ANOVA||||
1657599|NCT01586156|3050557|Superiority|||||||0.04|||||||ANOVA||||
1657600|NCT01585987|3050562|Superiority or Other||Odds Ratio (OR)|4.0549||||0.3686|2-Sided|80.0|0.7009|47.6447||Significance level used: 0.2|Cochran-Mantel-Haenszel||||
1657601|NCT01585987|3050564|Superiority or Other||Hazard Ratio (HR)|0.874||||0.6433|2-Sided|80.0|0.602|1.269||Significance level used: 0.2|Log Rank||HR was based on a stratified Cox proportional hazards model with treatment arm as the only covariate in the model.||
1657602|NCT01585987|3050565|Superiority or Other||Hazard Ratio (HR)|1.588||||0.0336|2-Sided|80.0|1.199|2.103||Significance level used: 0.2|Log Rank||||
1657603|NCT01585987|3050566|Superiority or Other||Hazard Ratio (HR)|1.439||||0.0972|2-Sided|80.0|1.085|1.908||Significance level used: 0.2|Log Rank||The hazard ratio and its associated two-sided 80% confidence interval (CI) was estimated via a stratified Cox model with treatment arm as the only covariate in the model||
1657604|NCT01585324|3050707|Superiority or Other|||||||0.0333|||||||Wilcoxon (Mann-Whitney)||||
1657605|NCT01585324|3050709|Superiority or Other|||||||0.6492|||||||ANCOVA||||
1657606|NCT01585324|3050711|Superiority or Other|||||||0.0867|||||||Fisher Exact||||
1657607|NCT01585324|3050713|Superiority or Other|||||||0.8333|||||||ANCOVA|The analysis of covariance (ANCOVA) test for the efficacy of SVR achievement (Yes/No), treatment adjustment and baseline hemoglobin value was used.|||
1657608|NCT01585246|3050724|Other||Maximum Tolerated Dose (MTD)|960.0|||||2-Sided|||||||||The time-to-event continual reassessment method (TITE-CRM) was used The TITE-CRM incorporated a decision rule for the allocation of next participant to a dose of SP based on the current estimate of toxicity. The first men were allocated to lowest dose (320 mg); when no adverse event was reported during 12 weeks, the dose was increased to 640 mg for next men, and then to 960 mg in the absence of advert event.|
1657609|NCT01585168|3050728|Other||Median Difference (Net)|1.8348|||<|0.05|2-Sided||||||t-test, 2 sided||||
1657610|NCT01585168|3050728|Other||Mean Difference (Net)|2.7264|||<|0.05|2-Sided|||||P value was adjusted for multiple comparisons using FWE (family wise error) correction.|t-test, 2 sided||FHP was found to have lower mean BOLD activation while given drug compared to placebo in anterior cingulate cortex.||
1657611|NCT01585168|3050731|Other||Median Difference (Net)|3.6615|||<|0.05|2-Sided||||||t-test, 2 sided||||
1657612|NCT01585168|3050731|Other||Mean Difference (Net)|2.4109|||<|0.05|2-Sided|||||P value was adjusted for multiple comparisons using FWE (family wise error) correction.|t-test, 2 sided|A Paired t-test was performed to explore the difference between two groups.|FHN was found to have lower mean BOLD activation while given drug compared to placebo in amygdala.||
1657613|NCT01585038|3050739|Superiority or Other||Mean Difference (Net)|-194.1||||0.02|2-Sided|95.0|-353.7|-34.6|||t-test, 2 sided||||
1657615|NCT01585038|3050741|Superiority or Other||Mean Difference (Net)|-1.21||||0.35|2-Sided|95.0|-4.71|2.3|||t-test, 2 sided||||
1657616|NCT01585038|3050742|Superiority or Other||Mean Difference (Net)|0.54||||0.3|2-Sided|95.0|-1.56|2.64|||t-test, 1 sided||||
1657617|NCT01585025|3050743|Superiority|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score|
1657618|NCT01585025|3050743|Superiority|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score|
1657619|NCT01585025|3050743|Superiority|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||Paired difference in weekly index score|
1657620|NCT01585025|3050744|Superiority|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form|
1657621|NCT01585025|3050744|Superiority|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form|
1657622|NCT01585025|3050744|Superiority|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Change in median stool form|
1657623|NCT01585025|3050745|Superiority|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week|
1657624|NCT01585025|3050745|Superiority|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week|
1657625|NCT01585025|3050745|Superiority|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in number of stools per week|
1657626|NCT01585025|3050746|Superiority|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC|
1657627|NCT01585025|3050746|Superiority|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC|
1657628|NCT01585025|3050746|Superiority|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in bile acid 6h AUC|
1657629|NCT01585025|3050747|Superiority|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4|
1657630|NCT01585025|3050747|Superiority|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4|
1657631|NCT01585025|3050747|Superiority|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Change in fasting C4|
1657632|NCT01585025|3050748|Superiority|||||||0.13|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC|
1657633|NCT01585025|3050748|Superiority|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC|
1657634|NCT01585025|3050748|Superiority|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Change in FGF19 AUC|
1657635|NCT01585025|3050749|Superiority|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment|
1657636|NCT01585025|3050749|Superiority|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment|
1657637|NCT01585025|3050749|Superiority|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Paired comparison of fasting FGF19 at baseline on day 0 and on day 14 of OCA treatment|
1657638|NCT01584843|3050766|Superiority or Other||Mean Difference (Final Values)|-3.87||||0.49|2-Sided|95.0|-15.21|7.47|||Fisher LSD method||||
1657639|NCT01584843|3050766|Superiority or Other||Mean Difference (Final Values)|-16.72||||0.005|2-Sided|95.0|-28.06|-5.38|||Fisher LSD method||||
1657640|NCT01584843|3050766|Superiority or Other||Mean Difference (Final Values)|-12.85||||0.031|2-Sided|95.0|-24.46|-1.24|||Fisher LSD method||||
1657641|NCT01584843|3050766|Superiority or Other||Mean Difference (Final Values)|3.75||||0.524|2-Sided|95.0|-9.83|17.33|||Fisher LSD method||||
1657642|NCT01584843|3050766|Superiority or Other||Mean Difference (Final Values)|-6.08||||0.338|2-Sided|95.0|-20.39|8.23|||Fisher LSD method||||
1657643|NCT01584843|3050766|Superiority or Other||Mean Difference (Final Values)|-9.83||||0.091|2-Sided|95.0|-21.81|2.14||LSD=Least Significant Difference|Fisher LSD method||||
1657644|NCT01584648|3050783|Superiority or Other||Hazard Ratio (HR)|0.75||||0.035|2-Sided|95.0|0.57|0.99|||Log Rank|p-value from stratified log-rank test was adjusted for randomized strata: Baseline lactate dehydrogenase (LDH) and BRAF mutation status|Hazard ratios (HRs) were estimated using a Pike estimator. HRs were adjusted for randomized strata: Baseline LDH and BRAF mutation status.||
1657645|NCT01584232|3050813|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1657646|NCT01584232|3050814|Superiority or Other||LS Mean Difference|-1.42|||<|0.001|2-Sided|95.0|-1.89|-0.94|||Mixed Models Analysis||||
1657647|NCT01584232|3050815|Superiority or Other||LS Mean Difference|6.21||||0.005|2-Sided|95.0|1.92|10.5||Treatment comparison for second pre-morning meal.|ANCOVA||||
1657648|NCT01584232|3050815|Superiority or Other||LS Mean Difference|-23.73|||<|0.001|2-Sided|95.0|-31.68|-15.79||Treatment comparison for bedtime.|ANCOVA||||
1657649|NCT01584232|3050815|Superiority or Other||LS Mean Difference|-31.13|||<|0.001|2-Sided|95.0|-39.26|-23.0||Treatment comparison for 2 hours post-evening meal.|ANCOVA||||
1657650|NCT01584232|3050815|Superiority or Other||LS Mean Difference|-13.63|||<|0.001|2-Sided|95.0|-21.03|-6.24||Treatment comparison for pre-evening meal.|ANCOVA||||
1657651|NCT01584232|3050815|Superiority or Other||LS Mean Difference|-23.22|||<|0.001|2-Sided|95.0|-31.92|-14.51||Treatment comparison for 2 hours post-midday meal.|ANCOVA||||
1657652|NCT01584232|3050815|Superiority or Other||LS Mean Difference|-8.22|||<|0.025|2-Sided|95.0|-15.37|-1.06||Treatment comparison for pre-midday meal.|ANCOVA||||
1657653|NCT01584232|3050815|Superiority or Other||LS Mean Difference|-13.4|||<|0.003|2-Sided|95.0|-22.28|-4.52||Treatment comparison for 2 hours post-morning meal.|ANCOVA||||
1657654|NCT01584232|3050815|Superiority or Other||LS Mean Difference|5.16|||<|0.022|2-Sided|95.0|0.76|9.56||Treatment comparison for pre-morning meal.|ANCOVA||||
1657655|NCT01584232|3050816|Superiority or Other||LS Mean Difference|3.5||||0.183|2-Sided|95.0|-1.7|8.7|||Mixed Models Analysis||||
1657656|NCT01584232|3050817|Superiority or Other||||||<|0.001||||||Treatment comparison for HbA1c <7%.|Regression, Logistic||||
1657657|NCT01584232|3050817|Superiority or Other||||||<|0.001||||||Treatment comparison for HbA1c <=6.5%.|Regression, Logistic||||
1657687|NCT01582854|3050892|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.14||0.455|2-Sided|95.0|-0.4|0.2|||ANCOVA|||Month 12|
1657688|NCT01582854|3050892|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.14||0.89|2-Sided|95.0|-0.3|0.2|||ANCOVA|||Month 6|
1657658|NCT01584232|3050818|Non-Inferiority or Equivalence|If the upper limit of the 95% Confidence Interval (CI) was <0.4%, then LY2189265 was declared non-inferior to insulin glargine. If the upper limit of the 95% CI was <0.0%, then LY2189265 was declared superior to insulin glargine.|LS Mean Difference|-0.54|||<|0.001|2-Sided|95.0|-0.67|-0.41||P-value is from the pairwise comparison of LS means using a mixed effects model with repeated measurements (MMRM).|Mixed Models Analysis|||Approximately 360 participants were to be randomized in a 1:1 ratio to LY2189265 or insulin glargine (IG). Assuming no difference in HbA1c change from baseline at Week 26 between LY2189265 and IG, this sample size would provide approximately 90% power to confirm non-inferiority of LY2189265 to IG. This computation was based on a non-inferiority margin of 0.4% with a standard deviation of 1.1%, a 1-sided alpha level of 0.025, and an 11% dropout rate between randomization and Week 26.|
1657659|NCT01584024|3050819|Superiority||||||=|0|||||||McNemar||||
1657660|NCT01584024|3050820|Superiority||||||=|0|||||||McNemar||||
1657661|NCT01583452|3050848|Superiority or Other|||||||0.83|||||||Kaplan-Meier survival analysis||||
1657662|NCT01583452|3050849|Superiority or Other|||||||0.059|||||||Kaplan-Meier survival analysis||||
1657663|NCT01583452|3050850|Superiority or Other|||||||0.094|||||||Kaplan-Meier survival analysis||||
1657664|NCT01583452|3050851|Superiority or Other|||||||0.665|||||||Kaplan-Meier survival analysis|||With a confidence interval of 95%, an alpha risk of 5% and a desired power of 80%; expecting a 24hrs difference between the intervention and the control group, we estimated 20 patients for each one of them.|
1657665|NCT01583374|3050855|Superiority||LS Mean Difference|0.03||||0.5938|2-Sided|95.0|-0.08|0.14|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.|||
1657666|NCT01583374|3050855|Superiority||LS Mean Difference|0.06||||0.3307|2-Sided|95.0|-0.06|0.17|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.|||
1657667|NCT01583374|3050856|Superiority||LS Mean Difference|-0.04||||0.9587|2-Sided|95.0|-1.5|1.42|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.|||
1657668|NCT01583374|3050856|Superiority||LS Mean Difference|0.29||||0.6997|2-Sided|95.0|-1.18|1.76|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.|||
1657669|NCT01583374|3050857|Superiority||LS Mean Difference|0.28||||0.4624|2-Sided|95.0|-0.46|1.01|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.|||
1657670|NCT01583374|3050857|Superiority||LS Mean Difference|0.25||||0.5126|2-Sided|95.0|-0.49|0.99|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.|||
1657671|NCT01583374|3050858|Superiority||Risk Difference (RD)|4.4||||0.4051|2-Sided|95.0|-5.8|14.5|||Cochran-Mantel-Haenszel|2 sided p-value was based on the CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category.|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.||
1657672|NCT01583374|3050858|Superiority||Risk Difference (RD)|2.0||||0.6958|2-Sided|95.0|-8.1|12.2|||Cochran-Mantel-Haenszel|2 sided p-value was based on the CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category.|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.||
1657673|NCT01583374|3050859|Superiority||LS Mean Difference|-0.09||||0.6262|2-Sided|95.0|-0.45|0.27|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.|||
1657674|NCT01583374|3050859|Superiority||LS Mean Difference|0.03||||0.8618|2-Sided|95.0|-0.33|0.4|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.|||
1657675|NCT01583374|3050860|Superiority||LS Mean Difference|-0.17||||0.3624|2-Sided|95.0|-0.53|0.19|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.|||
1657676|NCT01583374|3050860|Superiority||LS Mean Difference|-0.05||||0.8032|2-Sided|95.0|-0.41|0.32|||ANCOVA|Based on an ANCOVA model for change from baseline with treatment group, CRP and baseline BASDAI score as factors and baseline value as covariate.|||
1657677|NCT01583374|3050861|Superiority||Risk Difference (RD)|-1.7||||0.7427|2-Sided|95.0|-12.0|8.5|||Cochran-Mantel-Haenszel|2 sided p-value was based on CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category|Adjusted difference in proportions is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel weights.||
1657678|NCT01583374|3050861|Superiority or Other (legacy)||Risk Difference (RD)|-4.1||||0.4383|2-Sided|95.0|-14.3|6.2|||Cochran-Mantel-Haenszel|2 sided p-value was based on CMH test adjusting for C-reactive protein (CRP) category and baseline BASDAI score category|Adjusted difference is the weighted average of the treatment differences across the 4 strata of screening CRP category and baseline BASDAI score category with the Cochran-Mantel-Haenszel (CMH) weights||
1657679|NCT01583218|3050862|Superiority||Relative Risk Reduction (RRR)|0.358||||0.039|2-Sided|95.0|0.02|0.58|||Cochran-Mantel-Haenszel||||
1657680|NCT01583218|3050863|Superiority||Relative Risk Reduction (RRR)|0.295||||0.11|2-Sided|95.0|-0.085|0.542|||Cochran-Mantel-Haenszel||||
1657681|NCT01583218|3050864|Superiority||Relative Risk Reduction (RRR)|0.326||||0.092|2-Sided|95.0|-0.069|0.576|||Cochran-Mantel-Haenszel||||
1657682|NCT01583218|3050865|Superiority|||||||0.554|||||||Chi-squared||||
1657683|NCT01583218|3050866|Superiority||Relative Risk Reduction (RRR)|0.254||||0.003|2-Sided|95.0|0.092|0.387|||Cochran-Mantel-Haenszel||||
1657684|NCT01583218|3050867|Superiority||Relative Risk Reduction (RRR)|0.216||||0.018|2-Sided|95.0|0.041|0.359|||Cochran-Mantel-Haenszel||||
1657685|NCT01583218|3050868|Superiority||Relative Risk Reduction (RRR)|0.209||||0.038|2-Sided|95.0|0.013|0.366|||Cochran-Mantel-Haenszel||||
1657686|NCT01583166|3050873|Other|||||||0.837|||||||Fisher Exact||||
1657689|NCT01582854|3050892|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.14||0.136|2-Sided|95.0|-0.5|0.1|||ANCOVA|||Month 3|
1657690|NCT01582854|3050892|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.14||0.239|2-Sided|95.0|-0.4|0.1|||ANCOVA|||End of Infusion Period|
1657691|NCT01582854|3050893|Superiority or Other||Percent Difference|-4.0||||0.221|2-Sided|95.0|-9.7|1.7|||Fisher Exact|||Month 12|
1657692|NCT01582854|3050893|Superiority or Other||Percent Difference|-3.2||||0.251|2-Sided|95.0|-8.5|2.1|||Fisher Exact|||Month 6|
1657693|NCT01582854|3050894|Superiority or Other||Percent Difference|10.1||||0.035|2-Sided|95.0|0.8|19.3|||Chi-squared|||Month 12|
1657694|NCT01582854|3050894|Superiority or Other||Percent Difference|10.2||||0.034|2-Sided|95.0|0.8|19.5|||Chi-squared|||Month 6|
1657695|NCT01582854|3050894|Superiority or Other||Percent Difference|10.2||||0.032|2-Sided|95.0|0.9|19.5|||Chi-squared|||Month 3|
1657696|NCT01582854|3050895|Superiority or Other||LS Mean Difference|1.0|Standard Error of the Mean|0.34||0.003|2-Sided|95.0|0.3|1.7|||ANCOVA|||Month 12|
1657697|NCT01582854|3050895|Superiority or Other||LS Mean Difference|0.7|Standard Error of the Mean|0.29||0.013|2-Sided|95.0|0.2|1.3|||ANCOVA|||Month 6|
1657698|NCT01582854|3050895|Superiority or Other||LS Mean Difference|0.7|Standard Error of the Mean|0.27||0.016|2-Sided|95.0|0.1|1.2|||ANCOVA|||Month 3|
1657699|NCT01582854|3050895|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.2||0.111|2-Sided|95.0|-0.1|0.7|||ANCOVA|||End of Infusion Period|
1657700|NCT01582854|3050896|Superiority or Other||LS Mean Difference|-3.7|Standard Error of the Mean|0.93|<|0.001|2-Sided|95.0|-5.5|-1.9|||ANCOVA|||Month 12|
1657701|NCT01582854|3050896|Superiority or Other||LS Mean Difference|-1.1|Standard Error of the Mean|0.74|<|0.122|2-Sided|95.0|-2.6|0.3|||ANCOVA|||Month 3|
1657702|NCT01582854|3050897|Superiority or Other||LS Mean Difference|-2.3|Standard Error of the Mean|0.82||0.005|2-Sided|95.0|-3.9|-0.7|||ANCOVA||||
1657703|NCT01582308|3050941|Superiority or Other||Least squares mean difference|87.13|||<|0.001|2-Sided|90.0|80.06|94.61||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.|
1657704|NCT01582308|3050941|Superiority or Other||Least squares mean difference|25.38|||<|0.001|2-Sided|90.0|15.37|35.48||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.|
1657705|NCT01582308|3050941|Superiority or Other||Least squares mean difference|-61.75|||<|0.001|2-Sided|90.0|-68.76|-55.18||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.|
1657706|NCT01582308|3050941|Superiority or Other||Least squares mean difference|70.0|||<|0.001|2-Sided|90.0|58.46|82.2||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.|
1657707|NCT01582308|3050941|Superiority or Other||Least squares mean difference|-17.13|||<|0.001|2-Sided|90.0|-21.21|-13.25||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.|
1657708|NCT01582308|3050941|Superiority or Other||Least squares mean difference|44.62|||<|0.001|2-Sided|90.0|34.51|55.23||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.|
1657709|NCT01582308|3050941|Superiority or Other||Least squares mean difference|88.24|||<|0.001|2-Sided|90.0|85.77|90.76||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.|
1657710|NCT01582308|3050941|Superiority or Other||Least squares mean difference|1.11|||<|0.128|2-Sided|90.0|-0.1|2.33||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.|
1657711|NCT01582308|3050941|Superiority or Other||Least squares mean difference|62.86|||<|0.001|2-Sided|90.0|58.21|67.74||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.|
1657712|NCT01582308|3050941|Superiority or Other||Least squares mean difference|18.24|||<|0.001|2-Sided|90.0|14.97|21.67||P-value of between-treatment comparison of percent inhibition of DPP-4 activity.|Linear mixed effects model|||Analysis model included fixed effects terms for treatment and period.|
1657713|NCT01582282|3050942|Superiority or Other||Mean Difference (Final Values)|6.45||||0.811|||||||ANCOVA||||
1657714|NCT01582282|3050942|Superiority or Other||Mean Difference (Final Values)|7.14||||0.785|||||||ANCOVA||||
1657715|NCT01582282|3050943|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.978|||||||ANCOVA||||
1657716|NCT01582282|3050943|Superiority or Other||Mean Difference (Final Values)|7.84||||0.363|||||||ANCOVA||||
1657717|NCT01582282|3050944|Superiority or Other||Mean Difference (Final Values)|0.43||||0.962|||||||ANCOVA||||
1657718|NCT01582282|3050944|Superiority or Other||Mean Difference (Final Values)|6.1||||0.508|||||||ANCOVA||||
1657719|NCT01582282|3050945|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.328|||||||ANCOVA||||
1657720|NCT01582282|3050945|Superiority or Other||Mean Difference (Final Values)|0.48||||0.808|||||||ANCOVA||||
1657721|NCT01582282|3050946|Superiority or Other||Mean Difference (Final Values)|0.65||||0.003|||||||ANCOVA||||
1657722|NCT01582282|3050946|Superiority or Other||Mean Difference (Final Values)|0.53||||0.013|||||||ANCOVA||||
1657723|NCT01582282|3050947|Superiority or Other||Mean Difference (Final Values)|40.72||||0.009|||||||ANCOVA||||
1657724|NCT01582282|3050947|Superiority or Other||Mean Difference (Final Values)|30.64||||0.028|||||||ANCOVA||||
1657725|NCT01582178|3050954|Superiority or Other|||||||0.89|||||||Fisher Exact||||
1657761|NCT01580098|3051128|Superiority or Other|||||||0.182|||||||Wilcoxon (Mann-Whitney)|||Blood pressure: diastolic|
1657726|NCT01581931|3050989|Non-Inferiority or Equivalence|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|98.79|Standard Deviation|10.0|||2-Sided|90.0|94.55|103.21|||||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.||
1657727|NCT01581931|3050990|Non-Inferiority or Equivalence|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|97.76|Standard Deviation|9.8|||2-Sided|90.0|93.64|102.07|||||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.||
1657728|NCT01581931|3050993|Non-Inferiority or Equivalence|Equivalence margin: the 90% confidence intervall has to be within the intervall (80%, 125%)|Adjusted geometric mean ratio|97.69|Standard Deviation|9.7|||2-Sided|95.0|93.63|101.94|||||Numerator: FDC tablet; denominator: single tablets of linagliptin and metformin; The dispersion parameter is actually the geometric coefficient of variation.||
1657729|NCT01581658|3051008|Superiority or Other||Geometric mean ratio|94.01|||||2-Sided|90.0|72.63|121.674|||||||
1657730|NCT01581658|3051008|Superiority or Other||Geometric mean ratio|92.18|||||2-Sided|90.0|71.216|119.305|||||||
1657731|NCT01581658|3051008|Superiority or Other||Geometric mean ratio|93.5|||||2-Sided|90.0|72.236|121.015|||||||
1657732|NCT01581658|3051009|Superiority or Other||Geometric mean ratio|152.31|||||2-Sided|90.0|125.287|185.166|||||||
1657733|NCT01581658|3051009|Superiority or Other||Geometric mean ratio|143.82|||||2-Sided|90.0|118.306|174.848|||||||
1657734|NCT01581658|3051009|Superiority or Other||Geometric mean ratio|128.82|||||2-Sided|90.0|105.962|156.604|||||||
1657735|NCT01581281|3051037|Superiority|||||||0.2139|||||||Fisher Exact|||The occurrence of treatment-related SAE’s was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS’s across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.|
1657736|NCT01581281|3051037|Superiority|||||||1|||||||Fisher Exact|||The occurrence of treatment-related SAE’s was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS’s across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.|
1657737|NCT01581281|3051037|Superiority|||||||0.3038|||||||Fisher Exact|||The occurrence of treatment-related SAE’s was assessed in two ways: 1) percentage of subjects who experience any treatment-related SAE in each of the three groups was compared using Fishers exact test; 2) rates of treatment-emergent SAS’s across the three groups were compared using a Poisson regression model. However, due to the small number of SAEs that were deemed treatment-emergent (4 in AMI, 1 in TPM, 0 in PBO), the parameter estimates did not converge for the Poisson regression model.|
1657738|NCT01581281|3051038|Superiority||Odds Ratio (OR)|0.89||||0.7611|2-Sided|95.0|0.49|1.62|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.|
1657739|NCT01581281|3051038|Superiority||Odds Ratio (OR)|2.31||||0.0754|2-Sided|95.0|0.95|5.62|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.|
1657740|NCT01581281|3051038|Superiority||Odds Ratio (OR)|2.07||||0.1557|2-Sided|95.0|0.85|5.05|||Fisher Exact|||Tolerability was assessed by calculating the percent of subjects who completed the entire 24 week treatment period and the corresponding 95% confidence intervals for each treatment group. Concerns regarding tolerability would be raised if the upper bound of a confidence interval was less than 65% or if the percent of subjects who completed the entire 24 week treatment period in either of the active treatment groups was significantly less than the placebo group.|
1657741|NCT01581281|3051039|Superiority||Median Difference (Final Values)|-0.08||||0.9038|2-Sided|98.3|-1.68|1.52||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).|
1657742|NCT01581281|3051039|Superiority||Median Difference (Final Values)|-0.64||||0.4143|2-Sided|98.3|-2.52|1.24||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).|
1657762|NCT01580098|3051129|Superiority or Other|||||||0.025|||||||Wilcoxon (Mann-Whitney)||||
1657794|NCT01578850|3051266|Superiority or Other||Mean Difference (Final Values)|-8.69|||<|0.001|2-Sided|95.0|-12.33|-5.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ESR: Week 36|
1657983|NCT01576718|3051491|Superiority or Other||LSM difference|-0.047||||0.2241|2-Sided|95.0|-0.122|0.029||0.05 level of significance.|mixed model for repeated measures||||
1657743|NCT01581281|3051039|Superiority||Mean Difference (Final Values)|-0.72||||0.3553|2-Sided|98.3|-2.59|1.15||Each comparison was tested using a Bonferroni corrected significance level of 0.017 (0.05/3).|Regression, Linear|||Another major secondary objective was to determine if the change in absolute headache days from baseline to week 24 differed between treatment groups. This objective was assessed using linear regression models, with three pairwise comparisons between treatment groups (Amitriptyline vs. Placebo, Topiramate vs. Placebo, and Amitriptyline vs. Topiramate). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).|
1657744|NCT01581281|3051040|Superiority||Mean Difference (Final Values)|4.49||||0.1011|2-Sided|95.0|-0.88|9.87|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).|
1657745|NCT01581281|3051040|Superiority||Median Difference (Final Values)|-4.84||||0.1331|2-Sided|95.0|-11.16|1.49|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).|
1657746|NCT01581281|3051040|Superiority||Mean Difference (Final Values)|-0.35||||0.9137|2-Sided|95.0|-6.64|5.95|||Regression, Linear|||The mean change from baseline in PedMIDAS score over time for the three groups was assessed using a linear regression model for each of the three pairwise comparisons (Amitriptyline relative to placebo, Topiramate relative to placebo, and Amitriptyline relative to Topiramate), adjusted for the baseline PedMIDAS score. The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).|
1657747|NCT01581281|3051041|Superiority||Odds Ratio (OR)|0.88||||0.6107|2-Sided|98.3|0.49|1.59||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons of interest, the Bonferroni corrected level of significance is 0.017 ( = 0.05 / 3).|Regression, Logistic|||Logistic regression models were used to estimate the odds of successful primary endpoint for topiramate relative to amitriptyline. The analyses followed the intention to treat principle, imputing an outcome of “failure” for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).|
1657748|NCT01581281|3051041|Superiority||Odds Ratio (OR)|0.81||||0.4821|2-Sided|98.3|0.39|1.68||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons of interest, the Bonferroni corrected level of significance is 0.017 ( = 0.05 / 3).|Regression, Logistic|||Logistic regression models were used to estimate the odds of successful primary endpoint for topiramate relative to placebo. The analyses followed the intention to treat principle, imputing an outcome of “failure” for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).|
1657749|NCT01581281|3051041|Superiority||Odds Ratio (OR)|0.71||||0.2636|2-Sided|98.3|0.34|1.48||A Bonferroni approach was used to control the type I error rate. Because there were three comparisons, the Bonferroni corrected level of significance is 0.017 (= 0.05 / 3).|Regression, Logistic|||Logistic regression models were used to estimate the odds of successful primary endpoint for amitriptyline relative to placebo. The analyses followed the intention to treat principle, imputing an outcome of “failure” for any participant who withdrew early for any reason or did not provide week 24 headache diary data (endpoint data). The models, and corresponding odds ratios, were adjusted for the two stratification variables (age and baseline number of headache days).|
1657750|NCT01580995|3051050|Superiority or Other|||||||0.05|||||||Fisher Exact||||
1657751|NCT01580592|3051075|Superiority or Other|||||||0.988|||||||Chi-squared||||
1657752|NCT01580592|3051076|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Deviation|3.9|||2-Sided||||||||||
1657753|NCT01580592|3051076|Superiority or Other||Mean Difference (Final Values)|10.4|Standard Deviation|9.4||0.01|2-Sided||||||ANOVA||||
1657754|NCT01580592|3051076|Superiority or Other||Mean Difference (Final Values)|-10.6|Standard Deviation|7.6||0.001|2-Sided||||||ANOVA||for omalizumab 150mg||
1657755|NCT01580306|3051092|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|120.98|Standard Deviation|115.0|||2-Sided|90.0|47.257|309.736|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison severe : normal|
1657756|NCT01580306|3051092|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|175.52|Standard Deviation|70.4|||2-Sided|90.0|89.55|344.06|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison moderate : normal|
1657757|NCT01580306|3051092|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|107.22|Standard Deviation|107.7|||2-Sided|90.0|35.16|327.01|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison mild : normal|
1657758|NCT01580306|3051093|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|169.21|Standard Deviation|97.7|||2-Sided|90.0|73.19|391.17|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison severe : normal|
1657759|NCT01580306|3051093|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|178.31|Standard Deviation|78.9|||2-Sided|90.0|85.23|373.03|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison moderate : normal|
1657760|NCT01580306|3051093|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|113.57|Standard Deviation|93.2|||2-Sided|90.0|41.58|310.17|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison mild : normal|
1657763|NCT01579916|3051160|Non-Inferiority or Equivalence|H0 (null): Rate difference greater than or equal to 5 percentage points. This corresponds to a null hypothesis of: HA (alternative): rate difference < 5 percentage points.|Rate difference|-1.7|||||2-Sided|95.0|-8.9|0.6||||||Comparison of the rate of fever between the 2 treatment groups was based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate increase (trivalent influenza virus vaccine minus placebo) evaluated against the prespecified equivalence criterion of 5 percentage points|
1657764|NCT01579747|3051163|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Normality of distribution was assessed with the Shapiro-Wilk test. For normally-distributed continuous variables, the groups’ distributions were described as means and standard deviations (SD). Student’s t-test was used to compare groups in these cases with statistically-significant differences summarized using 95% confidence intervals as appropriate. For all comparisons, two-tailed p<0.05 was considered statistically significant.|
1657765|NCT01579669|3051165|Superiority or Other|||||||0.016|||||||t-test, 2 sided|||Pre-post intervention comparison|
1657766|NCT01579669|3051166|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Pre-post intervention comparison|
1657767|NCT01579669|3051167|Superiority or Other|||||||0.0269|||||||t-test, 2 sided|||Pre-post comparison|
1657768|NCT01579578|3051173|Superiority or Other||Mean Difference (Final Values)|-5.0|Standard Error of the Mean|12.23||0.688|2-Sided|95.0|-30.81|20.81||two sided p value|ANCOVA|ANCOVA model including covariates for baseline tumour size, for the time from the baseline scan to randomisation and with a term for HER2 status.|the difference in LS means is estimated|60 patients had been considered to detect a -20% difference in the estimated average percentage change in tumour size at 8 weeks for AZD8931 plus paclitaxel compared to paclitaxel alone at a one-sided significance level of 10% with 90% power. This is based on a standard deviation of 30% for tumour data (on an absolute scale)|
1657769|NCT01579565|3051175|Superiority or Other|||||||0.2361||||||Treatment comparisons based on Wilcoxon rank-sum test stratified by randomization strata.|Wilcoxon rank-sum test||||
1657770|NCT01579565|3051176|Superiority or Other|||||||0.3286||||||Treatment comparisons are based on generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel||||
1657771|NCT01579565|3051177|Superiority or Other|||||||0.006||||||Treatment comparisons are based on Cochran-Mantel-Haenszel test adjusting for the randomization strata.|Cochran-Mantel-Haenszel||||
1657772|NCT01579565|3051178|Superiority or Other|||||||0.3923||||||Treatment comparisons are based on Cochran-Mantel-Haenszel test adjusting for the randomization strata.|Cochran-Mantel-Haenszel||||
1657773|NCT01579565|3051179|Superiority or Other|||||||0.0002||||||Generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel||||
1657774|NCT01579565|3051180|Superiority or Other|||||||0.0806||||||Chi-square test|Chi-squared||||
1657775|NCT01579565|3051181|Superiority or Other|||||||0.076||||||Chi-square test|Chi-squared||||
1657776|NCT01579565|3051182|Superiority or Other|||||||0.0001||||||Chi-square test|Chi-squared||||
1657777|NCT01579565|3051183|Superiority or Other|||||||0.0001||||||Chi-square test.|Chi-squared||||
1657778|NCT01579565|3051184|Superiority or Other||Mean Difference (Final Values)|-4.58|Standard Error of the Mean|1.192||0.0002||95.0|-6.917|-2.244||p-value is based on the generalized CMH test stratified by the randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302 – Placebo) is adjusted for the randomization strata.|||
1657779|NCT01579565|3051185|Superiority or Other||Mean Difference (Final Values)|0.59|Standard Error of the Mean|0.049||0.0001||95.0|0.494|0.686||p-value based on the generalized Cochran-Mantel-Haenszel (CMH) test stratified by the randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302 – Placebo) is adjusted for the randomization strata.|||
1657780|NCT01579305|3051211|Non-Inferiority or Equivalence|The non-inferiority margin is pre-defined as 15% i.e., if the difference in responder rates is significantly greater than -15% (i.e., the lower confidence limit is greater than -15%), statistical non-inferiority of VOLBELLA® to Restylane-L® is established.|Difference in responder rates|4.9|||||1-Sided|97.5|-6.7||||||Difference in responder rates is calculated as the responder rate at Month 3 for VOLBELLA® minus the responder rate at Month 3 for Restylane-L®.|The null hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3, and the alternative hypothesis is that VOLBELLA® is inferior to Restylane-L® in terms of responder rate at Month 3 with 15% pre-defined non-inferiority margin. To test the null hypothesis, a difference in responder rates of these products (VOLBELLA® - Restylane-L®) at Month 3 and a 1-sided 97.5% Wald confidence interval for the difference is calculated.|
1657781|NCT01579006|3051221|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test||||
1657782|NCT01579006|3051223|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test||||
1657783|NCT01579006|3051224|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test||||
1657784|NCT01579006|3051225|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test||||
1657785|NCT01579006|3051226|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test||||
1657786|NCT01579006|3051227|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test||||
1657787|NCT01579006|3051233|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test||||
1657788|NCT01579006|3051234|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test||||
1657789|NCT01579006|3051236|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test||||
1657790|NCT01579006|3051237|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test||||
1657791|NCT01579006|3051238|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test||||
1657792|NCT01578850|3051266|Superiority or Other||Mean Difference (Final Values)|-6.32|||<|0.001|2-Sided|95.0|-10.03|-2.6|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ESR: Week 52|
1657793|NCT01578850|3051266|Superiority or Other||Mean Difference (Final Values)|-7.59|||<|0.001|2-Sided|95.0|-11.38|-3.8|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ESR: Week 44|
1657975|NCT01576718|3051489|Superiority or Other||LSM difference|-4.51||||0.4634|2-Sided|95.0|-16.6|7.57||0.05 level of significance.|Regression, Linear||||
1657795|NCT01578850|3051266|Superiority or Other||Mean Difference (Final Values)|-5.86|||<|0.001|2-Sided|95.0|-9.23|-2.49|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ESR: Week 28|
1657796|NCT01578850|3051266|Superiority or Other||Mean Difference (Final Values)|-7.16|||<|0.001|2-Sided|95.0|-11.48|-2.85|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CRP: Week 52|
1657797|NCT01578850|3051266|Superiority or Other||Mean Difference (Final Values)|-7.75|||<|0.001|2-Sided|95.0|-12.06|-3.44|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CRP: Week 44|
1657798|NCT01578850|3051266|Superiority or Other||Mean Difference (Final Values)|-6.27|||<|0.011|2-Sided|95.0|-11.09|-1.46|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CRP: Week 36|
1657799|NCT01578850|3051266|Superiority or Other||Mean Difference (Final Values)|-5.22|||<|0.014|2-Sided|95.0|-9.39|-1.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CRP: Week 28|
1657800|NCT01578850|3051268|Superiority or Other||Mean Difference (Final Values)|-9.29|||<|0.001|2-Sided|95.0|-14.6|-3.99|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Pain VAS: Week 52|
1657801|NCT01578850|3051268|Superiority or Other||Mean Difference (Final Values)|-9.49|||<|0.001|2-Sided|95.0|-14.72|-4.26|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Pain VAS: Week 44|
1657802|NCT01578850|3051268|Superiority or Other||Mean Difference (Final Values)|-8.6|||<|0.001|2-Sided|95.0|-13.85|-3.34|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Pain VAS: Week 36|
1657803|NCT01578850|3051268|Superiority or Other||Mean Difference (Final Values)|-5.91|||<|0.017|2-Sided|95.0|-10.75|-1.06|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Pain VAS: Week 28|
1657804|NCT01578850|3051268|Superiority or Other||Mean Difference (Final Values)|-8.6|||<|0.001|2-Sided|95.0|-13.64|-3.55|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||General Health VAS: Week 52|
1657805|NCT01578850|3051268|Superiority or Other||Mean Difference (Final Values)|-8.19|||<|0.001|2-Sided|95.0|-13.2|-3.18|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||General Health VAS: Week 44|
1657806|NCT01578850|3051268|Superiority or Other||Mean Difference (Final Values)|-7.54|||<|0.003|2-Sided|95.0|-12.49|-2.59|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||General Health VAS: Week 36|
1657807|NCT01578850|3051268|Superiority or Other||Mean Difference (Final Values)|-4.21|||<|0.078|2-Sided|95.0|-8.91|0.48|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||General Health VAS: Week 28|
1657808|NCT01578850|3051270|Superiority or Other||Mean Difference (Final Values)|-19.66||||0.007|2-Sided|95.0|-33.78|-5.54|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Week 52|
1657809|NCT01578850|3051270|Superiority or Other||Mean Difference (Final Values)|-16.54||||0.019|2-Sided|95.0|-30.35|-2.73|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Week 44|
1657810|NCT01578850|3051270|Superiority or Other||Mean Difference (Final Values)|-17.04||||0.013|2-Sided|95.0|-30.39|-3.68|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Week 36|
1657811|NCT01578850|3051270|Superiority or Other||Mean Difference (Final Values)|-14.11||||0.033|2-Sided|95.0|-27.07|-1.16|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Week 28|
1657812|NCT01578850|3051272|Superiority or Other||Mean Difference (Final Values)|-0.82||||0.002|2-Sided|95.0|-1.33|-0.31|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Week 52|
1657813|NCT01578850|3051272|Superiority or Other||Mean Difference (Final Values)|-0.83||||0.001|2-Sided|95.0|-1.33|-0.33|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Week 44|
1657814|NCT01578850|3051272|Superiority or Other||Mean Difference (Final Values)|-0.93|||<|0.001|2-Sided|95.0|-1.44|-0.43|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Week 36|
1657815|NCT01578850|3051272|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.048|2-Sided|95.0|-1.0|-0.01|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Week 28|
1657816|NCT01578850|3051274|Superiority or Other||Mean Difference (Final Values)|-0.93|||<|0.001|2-Sided|95.0|-1.33|-0.53|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Week 52|
1657817|NCT01578850|3051274|Superiority or Other||Mean Difference (Final Values)|-0.94|||<|0.001|2-Sided|95.0|-1.35|-0.54|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Week 44|
1657818|NCT01578850|3051274|Superiority or Other||Mean Difference (Final Values)|-0.78|||<|0.001|2-Sided|95.0|-1.18|-0.38|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Week 36|
1657976|NCT01576718|3051489|Superiority or Other||LSM difference|-0.69||||0.9101|2-Sided|95.0|-12.59|11.22||0.05 level of significance.|Regression, Linear||||
1657819|NCT01578850|3051274|Superiority or Other||Mean Difference (Final Values)|-0.53|||<|0.005|2-Sided|95.0|-0.9|-0.16|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Week 28|
1657820|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-0.78||||0.081|2-Sided|95.0|-1.66|0.1|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||68 Swollen Joint Count: Week 52|
1657821|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-0.84||||0.064|2-Sided|95.0|-1.73|0.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||68 Swollen Joint Count: Week 44|
1657822|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.208|2-Sided|95.0|-1.46|0.32|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||68 Swollen Joint Count: Week 36|
1657823|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.368|2-Sided|95.0|-1.13|0.42|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||68 Swollen Joint Count: Week 28|
1657824|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-2.58||||0.002|2-Sided|95.0|-4.19|-0.97|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||68 Tender Joint Count: Week 52|
1657825|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-2.34||||0.004|2-Sided|95.0|-3.91|-0.76|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||68 Tender Joint Count: Week 44|
1657826|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-1.88||||0.017|2-Sided|95.0|-3.42|-0.35|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||68 Tender Joint Count: Week 36|
1657827|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-1.16||||0.115|2-Sided|95.0|-2.6|0.28|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||68 Tender Joint Count: Week 28|
1657828|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-0.48||||0.199|2-Sided|95.0|-1.22|0.25|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||28 Swollen Joint Count: Week 52|
1657829|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.131|2-Sided|95.0|-1.31|0.17|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||28 Swollen Joint Count: Week 44|
1657830|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.437|2-Sided|95.0|-1.04|0.45|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||28 Swollen Joint Count: Week 36|
1657831|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.68|2-Sided|95.0|-0.77|0.5|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||28 Swollen Joint Count: Week 28|
1657832|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-1.75||||0.002|2-Sided|95.0|-2.85|-0.66|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||28 Tender Joint Count: Week 52|
1657833|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-1.65||||0.003|2-Sided|95.0|-2.72|-0.57|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||28 Tender Joint Count: Week 44|
1657834|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-1.34||||0.015|2-Sided|95.0|-2.41|-0.27|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||28 Tender Joint Count: Week 36|
1657835|NCT01578850|3051276|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.062|2-Sided|95.0|-1.84|0.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||28 Tender Joint Count: Week 28|
1657836|NCT01578850|3051278|Superiority or Other||Difference in proportions|5.9||||0.196|2-Sided|95.0|-0.6|12.4|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 90: Week 52|
1657837|NCT01578850|3051278|Superiority or Other||Difference in proportions|4.6||||0.219|2-Sided|95.0|-0.97|10.08|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 90: Week 44|
1657838|NCT01578850|3051278|Superiority or Other||Difference in proportions|6.4||||0.073|2-Sided|95.0|0.41|12.48|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 90: Week 36|
1657839|NCT01578850|3051278|Superiority or Other||Difference in proportions|3.3||||0.41|2-Sided|95.0|-2.19|8.86|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 90: Week 28|
1657840|NCT01578850|3051278|Superiority or Other||Difference in proportions|-0.3||||0.921|2-Sided|95.0|-6.19|5.67|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 90: Week 24|
1657841|NCT01578850|3051278|Superiority or Other||Difference in proportions|16.0||||0.005|2-Sided|95.0|5.96|26.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 70: Week 52|
1657977|NCT01576718|3051490|Superiority or Other||LSM difference|-13.45||||0.0296|2-Sided|95.0|-25.57|-1.33||0.05 level of significance.|Regression, Linear||||
1657842|NCT01578850|3051278|Superiority or Other||Difference in proportions|18.5||||0.001|2-Sided|95.0|8.4|28.55|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 70: Week 44|
1657843|NCT01578850|3051278|Superiority or Other||Difference in proportions|17.3||||0.004|2-Sided|95.0|7.12|27.56|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 70: Week 36|
1657844|NCT01578850|3051278|Superiority or Other||Difference in proportions|7.1||||0.378|2-Sided|95.0|-3.37|17.5|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 70: Week 28|
1657845|NCT01578850|3051278|Superiority or Other||Difference in Proportions|-2.7||||0.702|2-Sided|95.0|-13.49|8.11|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 70: Week 24|
1657846|NCT01578850|3051278|Superiority or Other||Difference in Proportions|17.7||||0.014|2-Sided|95.0|7.3|28.16|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 50: Week 52|
1657847|NCT01578850|3051278|Superiority or Other||Difference in proportions|19.0||||0.006|2-Sided|95.0|8.59|29.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 50: Week 44|
1657848|NCT01578850|3051278|Superiority or Other||Difference in proportions|17.2||||0.012|2-Sided|95.0|6.76|27.56|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 50: Week 36|
1657849|NCT01578850|3051278|Superiority or Other||Difference in proportions|11.5||||0.226|2-Sided|95.0|1.59|21.34|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 50: Week 28|
1657850|NCT01578850|3051278|Superiority or Other||Difference in proportions|2.5||||0.584|2-Sided|95.0|-4.78|9.75|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 50: Week 24|
1657851|NCT01578850|3051278|Superiority or Other||Difference in proportions|10.8||||0.088|2-Sided|95.0|2.49|19.05|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 20: Week 52|
1657852|NCT01578850|3051278|Superiority or Other||Difference in proportions|10.1||||0.175|2-Sided|95.0|1.8|18.49|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 20: Week 44|
1657853|NCT01578850|3051278|Superiority or Other||Difference in proportions|11.4||||0.111|2-Sided|95.0|3.31|19.51|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 20: Week 36|
1657854|NCT01578850|3051278|Superiority or Other||Difference in proportions|9.8||||0.143|2-Sided|95.0|2.45|17.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 20: Week 28|
1657855|NCT01578850|3051278|Superiority or Other||Difference in proportions|-0.2||||0.742|2-Sided|95.0|-4.21|3.9|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||ACR 20: Week 24|
1657856|NCT01578850|3051280|Superiority or Other||Mean Difference (Final Values)|-4.27|||<|0.001|2-Sided|95.0|-6.7|-1.84|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: Week 52|
1657857|NCT01578850|3051280|Superiority or Other||Mean Difference (Final Values)|-4.33|||<|0.001|2-Sided|95.0|-6.78|-1.88|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: Week 44|
1657858|NCT01578850|3051280|Superiority or Other||Mean Difference (Final Values)|-3.54|||<|0.004|2-Sided|95.0|-5.97|-1.12|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: Week 36|
1657859|NCT01578850|3051280|Superiority or Other||Mean Difference (Final Values)|-2.22|||<|0.047|2-Sided|95.0|-4.4|-0.03|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: Week 28|
1657860|NCT01578850|3051280|Superiority or Other||Mean Difference (Final Values)|-4.02|||<|0.001|2-Sided|95.0|-6.36|-1.68|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: Week 52|
1657861|NCT01578850|3051280|Superiority or Other||Mean Difference (Final Values)|-4.02|||<|0.001|2-Sided|95.0|-6.37|-1.67|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: Week 44|
1657862|NCT01578850|3051280|Superiority or Other||Mean Difference (Final Values)|-3.38|||<|0.005|2-Sided|95.0|-5.72|-1.05|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: Week 36|
1657863|NCT01578850|3051280|Superiority or Other||Mean Difference (Final Values)|-2.1|||<|0.049|2-Sided|95.0|-4.19|-0.01|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: Week 28|
1657864|NCT01578850|3051282|Superiority or Other||Difference in proportions|12.1||||0.031|2-Sided|95.0|3.7|20.57|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: Remission: Week 52|
1657978|NCT01576718|3051490|Superiority or Other||LSM difference|-5.11|||=|0|2-Sided|95.0|-16.95|6.72||0.05 level of significance.|Regression, Linear||||
1657865|NCT01578850|3051282|Superiority or Other||Difference in proportions|9.0||||0.047|2-Sided|95.0|0.85|17.25|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: Remission: Week 44|
1657866|NCT01578850|3051282|Superiority or Other||Difference in proportions|10.3||||0.022|2-Sided|95.0|2.07|18.45|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: Remission: Week 36|
1657867|NCT01578850|3051282|Superiority or Other||Difference in proportions|0.0||||0.556|2-Sided|95.0|-8.03|8.0|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: Remission: Week 28|
1657868|NCT01578850|3051282|Superiority or Other||Difference in proportions|3.0||||0.672|2-Sided|95.0|-5.51|11.51|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: Remission: Week 24|
1657869|NCT01578850|3051282|Superiority or Other||Difference in proportions|28.3|||<|0.001|2-Sided|95.0|18.0|38.69|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: LDA: Week 52|
1657870|NCT01578850|3051282|Superiority or Other||Difference in proportions|32.0|||<|0.001|2-Sided|95.0|21.83|42.23|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: LDA: Week 44|
1657871|NCT01578850|3051282|Superiority or Other||Difference in proportions|27.2|||<|0.001|2-Sided|95.0|16.93|37.55|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: LDA: Week 36|
1657872|NCT01578850|3051282|Superiority or Other||Difference in proportions|17.7|||<|0.005|2-Sided|95.0|7.49|27.92|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: LDA: Week 28|
1657873|NCT01578850|3051282|Superiority or Other||Difference in proportions|3.3|||<|0.258|2-Sided|95.0|-3.57|10.13|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: LDA: Week 24|
1657874|NCT01578850|3051282|Superiority or Other||Difference in proportions|0.6|||<|0.358|2-Sided|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||SDAI: LDA: Baseline|
1657875|NCT01578850|3051282|Superiority or Other||Difference in proportions|9.0|||<|0.088|2-Sided|95.0|1.02|16.88|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: Remission: Week 52|
1657876|NCT01578850|3051282|Superiority or Other||Difference in proportions|9.6|||<|0.025|2-Sided|95.0|1.49|17.68|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: Remission: Week 44|
1657877|NCT01578850|3051282|Superiority or Other||Difference in proportions|8.4|||<|0.08|2-Sided|95.0|0.36|16.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: Remission: Week 36|
1657878|NCT01578850|3051282|Superiority or Other||Difference in proportions|0.4|||<|0.645|2-Sided|95.0|-7.15|8.03|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: Remission: Week 28|
1657879|NCT01578850|3051282|Superiority or Other||Difference in proportions|2.3|||<|0.774|2-Sided|95.0|-5.5|10.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: Remission: Week 24|
1657880|NCT01578850|3051282|Superiority or Other||Difference in proportions|24.0|||<|0.001|2-Sided|95.0|13.61|34.42|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: LDA: Week 52|
1657881|NCT01578850|3051282|Superiority or Other||Difference in proportions|27.1|||<|0.001|2-Sided|95.0|16.85|37.35|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: LDA: Week 44|
1657882|NCT01578850|3051282|Superiority or Other||Difference in proportions|24.1|||<|0.001|2-Sided|95.0|13.88|34.4|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: LDA: Week 36|
1657883|NCT01578850|3051282|Superiority or Other||Difference in proportions|18.3|||<|0.004|2-Sided|95.0|8.4|28.27|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: LDA: Week 28|
1657884|NCT01578850|3051282|Superiority or Other||Difference in proportions|3.4|||<|0.341|2-Sided|95.0|-2.38|9.16|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: LDA: Week 24|
1657885|NCT01578850|3051282|Superiority or Other||Difference in proportions|0.6|||<|0.358|2-Sided|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||CDAI: LDA Baseline|
1657886|NCT01578850|3051284|Superiority or Other||Difference in proportions|11.2||||0.016|2-Sided|95.0|4.92|17.58|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Moderate Response: DAS28-CRP Week 52|
1657887|NCT01578850|3051284|Superiority or Other||Difference in proportions|11.1||||0.048|2-Sided|95.0|4.15|18.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Moderate Response: DAS28-ESR Week 52|
1657888|NCT01578850|3051284|Superiority or Other||Difference in proportions|10.6||||0.03|2-Sided|95.0|4.2|17.06|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Moderate Response: DAS28-ESR Week 44|
1657889|NCT01578850|3051284|Superiority or Other||Difference in proportions|11.7||||0.035|2-Sided|95.0|4.69|18.72|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Moderate Response: DAS28-ESR Week 44|
1657890|NCT01578850|3051284|Superiority or Other||Difference in proportions|8.8||||0.108|2-Sided|95.0|2.43|15.2|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Moderate Response: DAS28-CRP Week 36|
1657891|NCT01578850|3051284|Superiority or Other||Difference in proportions|9.9||||0.072|2-Sided|95.0|3.27|16.6|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Moderate Response: DAS28-ESR Week 36|
1657892|NCT01578850|3051284|Superiority or Other||Difference in proportions|6.5||||0.227|2-Sided|95.0|1.28|11.75|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Moderate Response: DAS28-CRP Week 28|
1657893|NCT01578850|3051284|Superiority or Other||Difference in Proportions|8.2||||0.091|2-Sided|95.0|2.32|14.1|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Moderate Response: DAS28-ESR Week 28|
1657894|NCT01578850|3051284|Superiority or Other||Difference in Proportions|0.0||||0.766|2-Sided|95.0|-1.69|1.65|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Good Response: DAS28-ESR Week 24|
1657895|NCT01578850|3051284|Superiority or Other||Difference in proportions|27.0|||<|0.001|2-Sided|95.0|16.63|37.44|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Good Response: DAS28-CRP Week 52|
1657896|NCT01578850|3051284|Superiority or Other||Difference in proportions|26.3|||<|0.001|2-Sided|95.0|16.82|35.74|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Good Response: DAS28-ESR Week 52|
1657897|NCT01578850|3051284|Superiority or Other||Difference in proportions|30.8|||<|0.001|2-Sided|95.0|20.54|41.05|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Good Response: DAS28-CRP Week 44|
1657898|NCT01578850|3051284|Superiority or Other||Difference in proportions|31.3|||<|0.001|2-Sided|95.0|21.53|41.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Good Response: DAS28-ESR Week 44|
1657899|NCT01578850|3051284|Superiority or Other||Difference in proportions|27.2|||<|0.001|2-Sided|95.0|16.83|37.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Good Response: DAS28-CRP Week 36|
1657900|NCT01578850|3051284|Superiority or Other||Difference in proportions|31.4|||<|0.001|2-Sided|95.0|21.42|41.39|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Good Response: DAS28-ESR Week 36|
1657901|NCT01578850|3051284|Superiority or Other||Difference in proportions|18.3|||<|0.007|2-Sided|95.0|8.08|28.53|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Good Response: DAS28-CRP Week 28|
1657902|NCT01578850|3051284|Superiority or Other||Difference in proportions|21.5|||<|0.001|2-Sided|95.0|10.99|32.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Good Response: DAS28-ESR Week 28|
1657903|NCT01578850|3051284|Superiority or Other||Difference in proportions|1.4|||<|0.961|2-Sided|95.0|-6.13|8.9|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||Good Response: DAS28-CRP Week 24|
1657904|NCT01578850|3051286|Superiority or Other||||||<|0.001|||||||Log Rank||||
1657905|NCT01578850|3051287|Superiority or Other||Mean Difference (Final Values)|-0.64|||<|0.001|2-Sided|95.0|-0.91|-0.36|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 52|
1657906|NCT01578850|3051287|Superiority or Other||Mean Difference (Final Values)|-0.69|||<|0.001|2-Sided|95.0|-0.98|-0.4|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-ESR Week 52|
1657907|NCT01578850|3051287|Superiority or Other||Mean Difference (Final Values)|-0.65|||<|0.001|2-Sided|95.0|-0.92|-0.37|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 44|
1657908|NCT01578850|3051287|Superiority or Other||Mean Difference (Final Values)|-0.75|||<|0.001|2-Sided|95.0|-1.03|-0.46|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-ESR Week 44|
1657909|NCT01578850|3051287|Superiority or Other||Mean Difference (Final Values)|-0.55|||<|0.001|2-Sided|95.0|-0.82|-0.28|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 36|
1657910|NCT01578850|3051287|Superiority or Other||Mean Difference (Final Values)|-0.68|||<|0.001|2-Sided|95.0|-0.96|-0.39|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-ESR Week 36|
1657979|NCT01576718|3051490|Superiority or Other||LSM difference|-6.58|||=|0.2724|2-Sided|95.0|-18.35|5.19||0.05 level of significance.|Regression, Linear||||
1657911|NCT01578850|3051287|Superiority or Other||Mean Difference (Final Values)|-0.36|||<|0.006|2-Sided|95.0|-0.61|-0.11|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 28|
1657912|NCT01578850|3051287|Superiority or Other||Mean Difference (Final Values)|-0.47|||<|0.001|2-Sided|95.0|-0.73|-0.2|||ANCOVA|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-ESR Week 28|
1657913|NCT01578850|3051289|Superiority or Other||Difference in proportions|27.2|||<|0.001|2-Sided|95.0|17.38|36.93|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 52|
1657914|NCT01578850|3051289|Superiority or Other||Difference in proportions|20.6|||<|0.001|2-Sided|95.0|11.78|29.52|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-ESR Week 52|
1657915|NCT01578850|3051289|Superiority or Other||Difference in proportions|30.9|||<|0.001|2-Sided|95.0|21.03|40.76|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 44|
1657916|NCT01578850|3051289|Superiority or Other||Difference in proportions|18.8|||<|0.001|2-Sided|95.0|10.16|27.38|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-ESR Week 44|
1657917|NCT01578850|3051289|Superiority or Other||Difference in proportions|24.9|||<|0.001|2-Sided|95.0|14.72|34.98|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 36|
1657918|NCT01578850|3051289|Superiority or Other||Difference in proportions|14.6|||<|0.007|2-Sided|95.0|5.48|23.8|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-ESR Week 36|
1657919|NCT01578850|3051289|Superiority or Other||Difference in proportions|16.9|||<|0.02|2-Sided|95.0|6.33|27.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 28|
1657920|NCT01578850|3051289|Superiority or Other||Difference in proportions|12.3|||<|0.034|2-Sided|95.0|2.86|21.69|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-ESR Week 28|
1657921|NCT01578850|3051289|Superiority or Other||Difference in proportions|1.3|||<|0.774|2-Sided|95.0|-9.03|11.68|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 24|
1657922|NCT01578850|3051291|Superiority or Other||Difference in proportions|27.1|||<|0.001|2-Sided|95.0|16.67|37.47|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 52|
1657923|NCT01578850|3051291|Superiority or Other||Difference in proportions|26.3|||<|0.001|2-Sided|95.0|16.78|35.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-ESR Week 52|
1657924|NCT01578850|3051291|Superiority or Other||Difference in proportions|30.2|||<|0.001|2-Sided|95.0|19.95|40.47|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 44|
1657925|NCT01578850|3051291|Superiority or Other||Difference in proportions|31.3|||<|0.001|2-Sided|95.0|21.51|41.08|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-ESR Week 44|
1657926|NCT01578850|3051291|Superiority or Other||Difference in proportions|27.2|||<|0.001|2-Sided|95.0|16.89|37.54|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 36|
1657927|NCT01578850|3051291|Superiority or Other||Difference in proportions|30.8|||<|0.001|2-Sided|95.0|20.79|40.83|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-ESR Week 36|
1657928|NCT01578850|3051291|Superiority or Other||Difference in proportions|19.0|||<|0.004|2-Sided|95.0|8.81|29.1|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 28|
1657929|NCT01578850|3051291|Superiority or Other||Difference in proportions|21.5|||<|0.001|2-Sided|95.0|10.99|32.02|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-ESR Week 28|
1657930|NCT01578850|3051291|Superiority or Other||Difference in proportions|2.6|||<|0.667|2-Sided|95.0|-4.76|9.98|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Week 24|
1657931|NCT01578850|3051291|Superiority or Other||Difference in proportions|0.6|||<|0.358|2-Sided|95.0|-0.59|1.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-CRP Baseline|
1657932|NCT01578850|3051291|Superiority or Other||Difference in proportions|-0.6|||<|0.371|2-Sided|95.0|-1.76|0.57|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).||DAS28-ESR Baseline|
1657933|NCT01578850|3051293|Superiority or Other||Difference in proportions|23.7||||0.019|2-Sided|95.0|6.83|40.61|||Cochran-Mantel-Haenszel|The p-value from CMH test of general association was stratified by geographic region.|||
1657980|NCT01576718|3051490|Superiority or Other||LSM difference|-5.68|||=|0.3531|2-Sided|95.0|-17.67|6.32||0.05 level of significance.|Regression, Linear||||
1657934|NCT01578850|3051294|Superiority or Other||Difference in Proportions|26.3|||<|0.001|2-Sided|95.0|16.78|35.81|||Cochran-Mantel-Haenszel|Stratified by geographic region and disease status at randomization (Stratum 1=Remission: DAS28-ESR<2.6 or Stratum 2=LDA: 2.6<=DAS28-ESR<3.2).|Participants who took rescue therapy had the final value taken before rescue used for analysis at all ensuing time points.||
1657935|NCT01578772|3051299|Superiority or Other||Median Difference (Final Values)|0.7|||<|0.05|2-Sided|95.0|-1.3|1.9|||Wilcoxon (Mann-Whitney)|Pairwise comparisons were performed using Wilcoxon signed rank test. All statistical tests are two-sided with nominal alpha level of 0.05.|||
1657936|NCT01578772|3051300|Superiority or Other||Median Difference (Net)|0.0|||<|0.05|2-Sided|95.0|-0.1|0.1|||Wilcoxon (Mann-Whitney)|Pairwise comparisons were performed using Wilcoxon signed rank test. All statistical tests are two-sided with nominal alpha level of 0.05.|||
1657937|NCT01578707|3051304|Superiority or Other (legacy)|||||||0.1653|||||||Log Rank||||
1657938|NCT01578707|3051305|Superiority||||||<|0.0001|||||||Fisher Exact||||
1657939|NCT01578707|3051306|Superiority||||||<|0.0001|||||||Log Rank||||
1657940|NCT01578499|3051324|Superiority or Other (legacy)||Estimate of difference|-19.0|||<|0.001|2-Sided|95.0|-26.7|-11.4|||ANCOVA|||P-value is calculated using the analysis of covariance (ANCOVA) model controlling for baseline symptom domain score, eastern cooperative oncology group (ECOG) performance status score (=0 and ≥1), and disease diagnosis (pcALCL and MF) between the brentuximab vedotin and comparator (methotrexate or bexarotene) arms.|
1657941|NCT01578499|3051325|Other||Hazard Ratio (HR)|0.378|||<|0.001|2-Sided|95.0|0.247|0.577|||Log Rank||||Hazard ratio brentuximab vedotin/ comparator (methotrexate or bexarotene) with the 95% CI from a stratified Cox regression model with treatment as the explanatory variable and baseline disease diagnosis (MF or pcALCL) as stratification factor.
1657942|NCT01578499|3051326|Superiority or Other (legacy)||Risk Difference (RD)|15.6||||0.0002|2-Sided|95.0|-2.5|33.0||P-value was stratified by baseline disease diagnosis (pcALCL and MF).|Cochran-Mantel-Haenszel||||
1657943|NCT01578499|3051327|Superiority or Other (legacy)||Risk Difference (RD)|42.2|||<|0.001|2-Sided|95.0|27.5|56.8||P-value was stratified by baseline disease diagnosis (pcALCL and MF).|Cochran-Mantel-Haenszel|||Based on a two-sided Χ² test with a significance level of 0.05, and a 10% dropout rate, a sample size of approximately 124 participants was calculated to provide 90% power to detect a 30% improvement in ORR4 in the brentuximab vedotin group.|
1657944|NCT01577537|3051407|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1657945|NCT01577329|3051441|Superiority or Other|||||||0.05||||||This is a calculated P value and was not adjusted for multiple comparisons.|ANOVA|||This is a calculated P value comparing two groups at baseline and follow-up|
1657946|NCT01577238|3051446|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1657947|NCT01576939|3051459|Superiority or Other||Slope|0.0567||||0.0039|2-Sided|95.0|0.0199|0.0935|||Mixed Models Analysis|A repeated measures model with dose as the single predictor and QoL values measured each week for each patient.|||
1657948|NCT01576939|3051460|Superiority or Other||Slope|0.03795||||0.0263|2-Sided|95.0|0.00483|0.071|||Mixed Models Analysis|A repeated measures model with dose as the single predictor. QoL values were measured for each patient every week.|||
1657949|NCT01576939|3051461|Superiority or Other||Slope|-0.285||||0.9832|2-Sided|95.0|-27.28|26.71|||Regression, Linear|Linear regression model with dose as the single predictor in the model.|||
1657950|NCT01576939|3051462|Superiority or Other||Slope|0.2795||||0.1209|2-Sided|95.0|-0.077|0.634|||Regression, Linear|Linear regression model with dose as the single predictor in the model.|||
1657951|NCT01576939|3051463|Superiority or Other||Cox Proportional Hazard|1.0||||0.9906|2-Sided|95.0|0.979|1.022|||Regression, Cox|This was a Cox proportional hazards model with dose as the single predictor.|||
1657952|NCT01576783|3051478|Other|The reported p-value is for the comparison of the change in Total Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.06||||||Threshold for statistical significance (<0.05).|Mixed Models Analysis||||
1657953|NCT01576783|3051478|Other|The reported p-value is for the comparison of the change in Daytime Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.07||||||Threshold for statistical significance (<0.05).|Mixed Models Analysis||||
1657954|NCT01576783|3051478|Other|The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.23||||||Threshold for statistical significance (<0.05).|Mixed Models Analysis||||
1657955|NCT01576783|3051482|Other|The reported p-value is for the comparison of the change in total sleep duration between groups (DHA+AA vs. Placebo).||||||0.32||||||Threshold for statistical significance (<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.|||
1657956|NCT01576783|3051482|Other|The reported p-value is for the comparison of the change in daytime sleep duration between groups (DHA+AA vs. Placebo).||||||0.47||||||Threshold for statistical significance (<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.|||
1657957|NCT01576783|3051482|Other|The reported p-value is for the comparison of the change in Nocturnal Sleep Duration between groups (DHA+AA vs. Placebo).||||||0.11||||||Threshold for statistical significance (<0.05).|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.|||
1657958|NCT01576783|3051483|Other|The reported p-value is for the comparison of the change in Motor Composite scores between groups (DHA+AA vs. Placebo).||||||0.88||||||Threshold for statistical significance (<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve >80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.|
1657981|NCT01576718|3051490|Superiority or Other||LSM difference|-5.56|||=|0.3568|2-Sided|95.0|-17.42|6.29||0.05 level of significance.|Regression, Linear||||
1657982|NCT01576718|3051491|Superiority or Other||LSM difference|-0.053||||0.1822|2-Sided|95.0|-0.13|0.025||0.05 level of significance.|mixed model for repeated measures||||
1657959|NCT01576783|3051483|Other|The reported p-value is for the comparison of the change in Language Composite scores between groups (DHA+AA vs. Placebo).||||||0.55||||||Threshold for statistical significance (<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve >80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.|
1657960|NCT01576783|3051483|Other|The reported p-value is for the comparison of the change in Cognitive Composite scores between groups (DHA+AA vs. Placebo).||||||0.66||||||Threshold for statistical significance (<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.||A sample of 448 was planned to achieve >80% power to detect a 4.2-point difference (0.27-standard deviation (SD)) in Bayley-III cognitive composite scores with 10% loss to follow-up.The investigational product manufacturer discontinued production once 377 were enrolled, thereby capping enrollment. That sample provided 80% power to detect a 0.29-SD difference in Bayley-III scores.|
1657961|NCT01576783|3051484|Other|The reported p-value is for the comparison of the change in Activity Level Composite scores between groups (DHA+AA vs. Placebo).||||||0.76||||||Threshold for statistical significance (<0.05)|Mixed Models Analysis||||
1657962|NCT01576783|3051484|Other|The reported p-value is for the comparison of the change in Effortful Control Composite scores between groups (DHA+AA vs. Placebo).||||||0.13||||||Threshold for statistical significance (<0.05)|Mixed Models Analysis|Analyses compared the change in scores between groups, using mixed effects regression that leveraged maximum likelihood to include missing data.|||
1657963|NCT01576783|3051487|Other|The reported p-value is for the comparison of the change in n-6:n-3 ratio between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-4.6|||<|0.001|2-Sided|95.0|-5.5|-3.7||Threshold for statistical significance (<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.|
1657964|NCT01576783|3051488|Other|The reported p-value is for the comparison of the change in Total n-3 between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|1.2|||<|0.001|2-Sided|95.0|0.9|1.4||Threshold for statistical significance (<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.|
1657965|NCT01576783|3051488|Other|The reported p-value is for the comparison of the change in Docosahexaenoic acid (22:6n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|1.2|||<|0.001|2-Sided|95.0|1.0|1.5||Threshold for statistical significance (<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.|
1657966|NCT01576783|3051488|Other|The reported p-value is for the comparison of the change in Docosapentaenoic acid (22:5n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-0.1|||<|0.001|2-Sided|95.0|-0.1|0.0||Threshold for statistical significance (<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.|
1657967|NCT01576783|3051488|Other|The reported p-value is for the comparison of the change in Eicosapentaenoic acid (20:5n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.0|||<|0.12|2-Sided|95.0|0.0|0.1||Threshold for statistical significance (<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.|
1657968|NCT01576783|3051488|Other|The reported p-value is for the comparison of the change in α-linolenic acid (18:3n-3) between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.0|||<|0.4|2-Sided|95.0|-0.1|0.1||Threshold for statistical significance (<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.|
1657969|NCT01576783|3051488|Other|The reported p-value is for the comparison of the change in Total n-6 mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|0.4|||<|0.61|2-Sided|95.0|-1.0|1.7||Threshold for statistical significance (<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.|
1657970|NCT01576783|3051488|Other|The reported p-value is for the comparison of the change in Arachidonic acid (20:4n-6) mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|2.2|||<|0.001|2-Sided|95.0|1.7|2.8||Threshold for statistical significance (<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.|
1657971|NCT01576783|3051488|Other|The reported p-value is for the comparison of the change in Linoleic acid (18:2n-6) mol% between groups (DHA+AA vs. Placebo).|Mean Difference (Final Values)|-2.2|||<|0.001|2-Sided|95.0|-3.4|0.9||Threshold for statistical significance (<0.05)|Mixed Models Analysis|||The change in erythrocyte fatty acids and the change in dietary DHA and EPA (aside from the supplement) were examined by treatment group using mixed effects regression, again with a random-effect for within-family dependence.|
1657972|NCT01576718|3051489|Superiority or Other||Slope|-9.05||||0.1469|2-Sided|95.0|-21.3|3.19||0.05 level of significance.|Regression, Linear||||
1657973|NCT01576718|3051489|Superiority or Other||LSM difference|-8.19||||0.1763|2-Sided|95.0|-20.06|3.69||0.05 level of significance.|Regression, Linear||||
1657974|NCT01576718|3051489|Superiority or Other||LSM difference|-5.88||||0.3333|2-Sided|95.0|-17.8|6.05||0.05 level of significance.|Regression, Linear||||
1657984|NCT01576718|3051491|Superiority or Other||LSM difference|-0.008||||0.8434|2-Sided|95.0|-0.083|0.068||0.05 level of significance.|mixed model for repeated measures||||
1657985|NCT01576718|3051491|Superiority or Other||LSM difference|0.004||||0.9245|2-Sided|95.0|-0.973|0.08||0.05 level of significance.|mixed model for repeated measures||||
1657986|NCT01576718|3051491|Superiority or Other||LSM difference|0.019|||=|0|2-Sided|95.0|-0.057|0.096||0.05 level of significance.|mixed model for repeated measures||||
1657987|NCT01576718|3051498|Superiority or Other||Mean Difference (Final Values)|-4.38||||0.4731|2-Sided|95.0|-16.57|7.82||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).|
1657988|NCT01576718|3051498|Superiority or Other||Mean Difference (Final Values)|-0.74||||0.90426|2-Sided|95.0|-13.02|11.54||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).|
1657989|NCT01576718|3051498|Superiority or Other||Mean Difference (Final Values)|-10.98||||0.05977|2-Sided|95.0|-22.64|0.68||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).|
1657990|NCT01576718|3051498|Superiority or Other||Mean Difference (Final Values)|0.9||||0.88116|2-Sided|95.0|-11.12|12.91||Significance at the 0.05 level|Regression, Linear|||Estimates computed from a generalized linear logistic model with gender and age as covariates and allows correlation between estimates on the same subject. Interpretation of the estimates is that they are the average over the population at the average level of continuous covariate (age) averaged over discrete covariate (gender).|
1657991|NCT01576718|3051499|Superiority or Other|||||||0.1006||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo|
1657992|NCT01576718|3051499|Superiority or Other|||||||0.0018||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo|
1657993|NCT01576718|3051499|Superiority or Other|||||||0.0058||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo|
1657994|NCT01576718|3051499|Superiority or Other|||||||0.034||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo|
1657995|NCT01576718|3051499|Superiority or Other|||||||0.0341||||||Significance level of 0.05.|Log Rank|||P-value for comparison of survival curve to placebo|
1657996|NCT01576718|3051500|Superiority or Other||LSM difference|0.39||||0.9487|2-Sided|95.0|-11.6|12.39||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.|
1657997|NCT01576718|3051500|Superiority or Other||LSM difference|2.99||||0.6258|2-Sided|95.0|-9.06|15.05||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.|
1657998|NCT01576718|3051500|Superiority or Other||LSM difference|4.03||||0.5167|2-Sided|95.0|-8.17|16.23||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.|
1657999|NCT01576718|3051500|Superiority or Other||LSM difference|7.56||||0.2166|2-Sided|95.0|-4.45|19.56||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.|
1658000|NCT01576718|3051500|Superiority or Other|||||||0.2879||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.|
1658001|NCT01576718|3051501|Superiority or Other||LSM difference|8.23||||0.1858|2-Sided|95.0|-3.98|20.45||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.|
1658002|NCT01576718|3051501|Superiority or Other||LSM difference|7.09||||0.2523|2-Sided|95.0|-5.07|19.26||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.|
1658003|NCT01576718|3051501|Superiority or Other||LSM difference|7.78||||0.2169|2-Sided|95.0|-4.59|20.15|||Regression, Linear|Significance at the 0.05 level||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.|
1658004|NCT01576718|3051501|Superiority or Other||LSM difference|7.36||||0.2361|2-Sided|95.0|-4.83|19.56||Significance at the 0.05 level|Regression, Linear|||No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.|
1658040|NCT01575834|3051599|Superiority||LS Mean Difference|5.8|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|5.6|6.0|||ANCOVA|||The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.|
1658130|NCT01573767|3051804|Superiority or Other||Mean Difference (Final Values)|7.5|||||2-Sided|95.0|0.7|14.2|||||||
1658005|NCT01576718|3051501|Superiority or Other|||||||0.1512||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.|
1658006|NCT01576718|3051502|Superiority or Other||LSM difference|0.006|||=|0|2-Sided|95.0|-0.07|0.083||Significance at the 0.05 level|mixed model for repeated measures||Fp 50 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.|
1658007|NCT01576718|3051502|Superiority or Other||LSM difference|0.048|||=|0.2221|2-Sided|95.0|-0.029|0.124||Significance at the 0.05 level|mixed model for repeated measures||Fp 100 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.|
1658008|NCT01576718|3051502|Superiority or Other||LSM difference|0.056|||=|0.1585|2-Sided|95.0|-0.022|0.133||Significance at the 0.05 level|mixed model for repeated measures||Fp 200 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.|
1658009|NCT01576718|3051502|Superiority or Other||LSM difference|0.072|||=|0.0637|2-Sided|95.0|-0.004|0.149||Significance at the 0.05 level.|mixed model for repeated measures||Fp 400 - Placebo|No explicit structure was assumed for the covariance among the repeated measures. Analyses for comparison of Fp MDPI to placebo did not contain FLOVENT DISKUS data.|
1658010|NCT01576718|3051502|Superiority or Other||||||=|0.0604||||||If the Fp MDPI showed a significantly positive trend, then contrasts for pairwise comparisons of each Fp MDPI dose versus placebo were done in the sequence of highest to lowest Fp MDPI dose.|Regression, Linear|||A linear in log-dose trend contrast was constructed to evaluate the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed at the 0.05 level of significance.|
1658011|NCT01576406|3051529|Superiority||Percentage of ratio of geometric mean|62.82|||||2-Sided|90.0|42.54|92.78||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.|
1658012|NCT01576406|3051529|Superiority||Percentage of ratio of geometric mean|130.78|||||2-Sided|90.0|86.61|197.47||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.|
1658013|NCT01576406|3051529|Superiority||Percentage of ratio of geometric mean|202.89|||||2-Sided|90.0|120.96|340.3||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.|
1658014|NCT01576406|3051529|Superiority||Percentage of ratio of geometric mean|108.43|||||2-Sided|90.0|63.47|185.26||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.|
1658015|NCT01576406|3051530|Superiority||Percentage of ratio of geometric mean|64.67|||||2-Sided|90.0|39.5|105.89||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.|
1658016|NCT01576406|3051530|Superiority||Percentage of ratio of geometric mean|114.08|||||2-Sided|90.0|73.57|176.89||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.|
1658017|NCT01576406|3051530|Superiority||Percentage of ratio of geometric mean|149.54|||||2-Sided|90.0|91.85|243.46||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.|
1658018|NCT01576406|3051530|Superiority||Percentage of ratio of geometric mean|91.12|||||2-Sided|90.0|56.56|146.79||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.|
1658019|NCT01576406|3051556|Superiority||Geometric mean ratio|72.63|||||2-Sided|90.0|49.07|107.5||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.|
1658020|NCT01576406|3051556|Superiority||Geometric mean ratio|108.87|||||2-Sided|90.0|70.13|168.99||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.|
1658021|NCT01576406|3051556|Superiority||Geometric mean ratio|143.82|||||2-Sided|90.0|89.11|232.12||||||CI: Geometric mean ratio and 90% CI were derived from ANOVA model.|
1658022|NCT01576406|3051556|Superiority||Geometric mean ratio|91.2|||||2-Sided|90.0|57.47|144.72||||||Confidence interval (CI): Geometric mean ratio and 90 percent (%) CI were derived from analysis of variance (ANOVA) model.|
1658023|NCT01576341|3051564|Other||Incidence rate|0.019|||||2-Sided||||||||Incidence rate is based on duration of treatment period (years)||
1658024|NCT01575912|3051587|Other|||||||0.121||||||using Mann Whitney test|Wilcoxon (Mann-Whitney)||||
1658025|NCT01575899|3051588|Superiority or Other||Odds Ratio (OR)|3.87|Standard Error of the Mean|3.2589||0.004|2-Sided|95.0|1.5|10.02|||Chi-squared||||
1658026|NCT01575899|3051590|Superiority or Other||Odds Ratio (OR)|2.629|Standard Error of the Mean|3.1526||0.008|2-Sided|95.0|1.28|5.42|||Chi-squared||||
1658027|NCT01575873|3051591|Superiority||LS Mean Difference|2.5|||<|0.001|2-Sided|95.0|1.7|3.2||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (< 12 months vs ≥ 12 months)."|
1658028|NCT01575873|3051591|Superiority||LS Mean Difference|3.1|||<|0.001|2-Sided|95.0|2.2|3.9||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."|
1658122|NCT01573767|3051801|Superiority or Other||Mean Difference (Final Values)|0.2|||||2-Sided|95.0|-7.2|7.5|||||||
1658208|NCT01573000|3051874|Superiority or Other|||||||0.016|||||||Log Rank||||
1658029|NCT01575873|3051592|Superiority||LS Mean Difference|3.2|||<|0.001|2-Sided|95.0|2.0|4.3||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (< 12 months vs ≥ 12 months)."|
1658030|NCT01575873|3051592|Superiority||LS Mean Difference|4.5|||<|0.001|2-Sided|95.0|3.2|5.8||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."|
1658031|NCT01575873|3051593|Superiority||LS Mean Difference|1.5|||<|0.001|2-Sided|95.0|1.0|2.1||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (< 12 months vs ≥ 12 months)."|
1658032|NCT01575873|3051593|Superiority||LS Mean Difference|1.5|||<|0.001|2-Sided|95.0|0.8|2.1||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."|
1658033|NCT01575873|3051594|Superiority||LS Mean Difference|2.2|||<|0.001|2-Sided|95.0|1.4|3.0||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (< 12 months vs ≥ 12 months)."|
1658034|NCT01575873|3051594|Superiority||LS Mean Difference|2.9|||<|0.001|2-Sided|95.0|2.0|3.9||2-sided p-value corresponding to the 2-sided 95% confidence interval|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD value, sex, machine type, and baseline BMD value-by-machine type interaction."|
1658035|NCT01575873|3051595|Non-Inferiority|Non-inferiority was shown if the lower bound of the two-sided 95% CI for the difference between the least-squares means (denosumab minus risedronate) was higher than the prespecified non-inferiority margin of –0.7 percentage points for the glucocorticoid-continuing subpopulation.|LS Mean Difference|2.2|||<|0.001|2-Sided|95.0|1.4|3.0||One-sided p-value based on the prespecified noninferiority margins for lumbar spine of -0.7%.|ANCOVA||LS Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within each subpopulation using a fixed-sequence testing procedure to control the experiment-wise type 1 error rate at a two-sided 5% significance level.~The glucocorticoid-continuing subpopulation was analyzed using an ANCOVA model adjusted for treatment, baseline BMD, sex, machine type, baseline BMD-by-machine type interaction, and duration of prior glucocorticoid use (< 12 months vs ≥ 12 months)."|
1658036|NCT01575873|3051595|Non-Inferiority|Non-inferiority was shown if the lower bound of the two-sided 95% CI for the difference between the least-squares means (denosumab minus risedronate) was higher than the prespecified non-inferiority margin of –1.1 percentage points for the glucocorticoid-initiating subpopulation.|LS Mean Difference|2.9|||<|0.001|2-Sided|95.0|2.0|3.9||One-sided p-value based on the prespecified noninferiority margin for lumbar spine of -1.1%.|ANCOVA||Least Squares (LS) Mean Difference = Denosumab - Risedronate|"Analyses of the primary and secondary endpoints were performed independently within the glucocorticoid-continuing and glucocorticoid-initiating subpopulations. A fixed-sequence testing procedure was used to control the experiment-wise type 1 error rate at a two-sided 5% significance level within each subpopulation.~The glucocorticoid-initiating subpopulation was analyzed using an ANCOVA model adjusting for treatment, baseline BMD, sex, machine type, and baseline BMD-by-machine type interaction."|
1658037|NCT01575834|3051596|Superiority||LS Mean Difference|4.9|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|4.7|5.2|||ANCOVA|||The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.|
1658038|NCT01575834|3051597|Superiority||LS Mean Difference|5.2|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|4.9|5.4|||ANCOVA|||The treatment comparison of BMD at the femoral neck was analyzed using an ANCOVA model which included included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.|
1658039|NCT01575834|3051598|Superiority||LS Mean Difference|5.3|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|5.1|5.5|||ANCOVA|||The treatment comparison of BMD at the total hip was analyzed using an ANCOVA model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.|
1658123|NCT01573767|3051802|Superiority or Other||Mean Difference (Final Values)|7.0||||||95.0|-2.7|16.7|||||||
1658124|NCT01573767|3051802|Superiority or Other||Mean Difference (Final Values)|9.7|||||2-Sided|95.0|0.0|19.3|||||||
1658041|NCT01575834|3051600|Superiority||LS Mean Difference|11.1|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|10.8|11.4|||ANCOVA|||The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.|
1658042|NCT01575834|3051601|Superiority||LS Mean Difference|12.7|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|12.4|12.9|||ANCOVA|||The treatment comparison of BMD at the lumbar spine was analyzed using an analysis of covariance (ANCOVA) model which included treatment, age and prevalent vertebral fracture stratification variables, and baseline value of the endpoint, machine type and machine type-by-baseline value interaction.|
1658043|NCT01575834|3051602|Superiority||Odds Ratio (OR)|0.06|||<|0.001|2-Sided|95.0|0.01|0.44|||Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values < 1 for odds ratio favor romosozumab.||
1658044|NCT01575834|3051603|Superiority||Odds Ratio (OR)|0.11||||0.011|2-Sided|95.0|0.01|0.87|||Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values < 1 for odds ratio favor romosozumab.||
1658045|NCT01575834|3051604|Superiority||Hazard Ratio (HR)|0.62||||0.002|2-Sided|95.0|0.46|0.84|||Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio < 1 favors romosozumab.||
1658046|NCT01575834|3051605|Superiority||Hazard Ratio (HR)|0.6||||0.012|2-Sided|95.0|0.4|0.9|||Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio < 1 favors romosozumab.||
1658047|NCT01575834|3051606|Superiority||Hazard Ratio (HR)|0.5||||0.12|2-Sided|95.0|0.24|1.04||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio < 1 favors romosozumab.||
1658048|NCT01575834|3051607|Superiority||Hazard Ratio (HR)|0.54||||0.18|2-Sided|95.0|0.22|1.35||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio < 1 favors romosozumab.||
1658049|NCT01575834|3051608|Superiority||Odds Ratio (OR)|0.26||||0.096|2-Sided|95.0|0.16|0.41||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test|Values < 1 for odds ratio favor romosozumab.||
1658050|NCT01575834|3051609|Superiority||Odds Ratio (OR)|0.28||||0.096|2-Sided|95.0|0.17|0.49||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values < 1 for odds ratio favor romosozumab.||
1658051|NCT01575834|3051610|Superiority||Hazard Ratio (HR)|0.67||||0.096|2-Sided|95.0|0.49|0.91||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio < 1 favors romosozumab||
1658052|NCT01575834|3051611|Superiority||Hazard Ratio (HR)|0.67||||0.096|2-Sided|95.0|0.44|1.02||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio < 1 favors romosozumab.||
1658053|NCT01575834|3051612|Superiority||Hazard Ratio (HR)|0.67||||0.096|2-Sided|95.0|0.52|0.87||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio < 1 favors romosozumab.||
1658054|NCT01575834|3051613|Superiority||Hazard Ratio (HR)|0.75||||0.057|2-Sided|95.0|0.57|0.97||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio < 1 favors romosozumab.||
1658055|NCT01575834|3051614|Superiority||Hazard Ratio (HR)|0.75||||0.096|2-Sided|95.0|0.53|1.05||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio < 1 favors romosozumab.||
1658056|NCT01575834|3051615|Superiority||Hazard Ratio (HR)|0.64||||0.008|2-Sided|95.0|0.46|0.89||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Cox proportional hazards|Cox proportional hazards model adjusting for age and prevalent vertebral fracture stratification variables.|Hazard ratio < 1 favors romosozumab.||
1658057|NCT01575834|3051616|Superiority||Odds Ratio (OR)|0.24|||<|0.001|2-Sided|95.0|0.15|0.39||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values < 1 for odds ratio favor romosozumab.||
1658125|NCT01573767|3051802|Superiority or Other||Mean Difference (Final Values)|5.9|||||2-Sided|95.0|-3.7|15.6|||||||
1658126|NCT01573767|3051803|Superiority or Other||Mean Difference (Final Values)|5.2|||||2-Sided|95.0|-4.4|14.9|||||||
1658058|NCT01575834|3051617|Superiority||Odds Ratio (OR)|0.27|||<|0.001|2-Sided|95.0|0.15|0.47||A fixed-sequence testing procedure was used for multiplicity adjustment of the coprimary and a subset of secondary efficacy endpoints to maintain the overall significance level at 0.05.|Regression, Logistic|Based on logistic regression model adjusted for age and prevalent vertebral fracture stratification variables; p-value based on score test.|Values < 1 for odds ratio favor romosozumab.||
1658059|NCT01575808|3051618|Other||Percentage|100.0|||||2-Sided|95.0|96.5|100.0|||||Confidence Interval calculated with binomial exact method.||
1658060|NCT01575808|3051638|Other||Percentage|97.1|||||2-Sided|95.0|91.7|99.4|||||||
1658061|NCT01575808|3051668|Superiority or Other||Percentage|100.0|||||2-Sided|95.0|96.5|100.0|||||Confidence intervals calculated using the binomial exact method.||
1658062|NCT01575808|3051669|Superiority or Other||Percentage|100.0|||<|0.0001|2-Sided|95.0|96.5|100.0|||Fisher Exact||Confidence interval calculated with binomial exact method.|The hypothesis is that the rate of avoidance of general anesthesia for GP1101 is superior to the rate of avoidance of general anesthesis for the retrospective surgical bypass group.|
1658063|NCT01575808|3051670|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Hypothesis is that the post-procedure hospital stay duration for GP1101 is superior to the post-procedure hospital stay for the retrospective surgical bypass group.|
1658064|NCT01575808|3051671|Superiority or Other||Percentage|91.0|||<|0.0001|1-Sided|95.0|86.3||||z-test|One-sided z-test||A literature-based Surgical Bypass Efficacy Goal of 65% was compared to the percentage of subjects maintaining primary assisted patency at 12 months. A one-sided z-test using a Type I error of 5% was performed to test the hypotheses that the 12-month primary assisted patency probability of GP1101 is superior to the SBEG of 65%.|
1658065|NCT01575197|3051730|Superiority or Other|||||||0.3|||||||t-test, 2 sided||||
1658066|NCT01575197|3051731|Superiority or Other|||||||0.038|||||||t-test, 2 sided||||
1658067|NCT01575197|3051732|Superiority or Other|||||||0.16|||||||Fisher Exact||||
1658068|NCT01575197|3051733|Superiority or Other|||||||0.014|||||||Fisher Exact||||
1658069|NCT01574716|3051748|Superiority||Difference|-0.6|||=|0|2-Sided|95.0|-12.0|10.9|||Log Rank|Two-sided log-rank test|Based on Cox PH model|Difference equal to (=) (MORAb 8.0 mg/kg + Gemcitabine/Docetaxel) minus (Placebo + Gemcitabine/Docetaxel). Confidence interval based on a normal approximation to the binomial distribution.|
1658070|NCT01574716|3051749|Superiority||Hazard Ratio (HR)|1.23||||0.3153|2-Sided|95.0|0.82|1.83|||Log Rank|Two-sided log-rank test|Based on Cox PH model||
1658071|NCT01574716|3051750|Superiority||Hazard Ratio (HR)|1.13|||=|0|2-Sided|95.0|0.82|1.57|||Log Rank|Two-sided log-rank test|Based on Cox PH model||
1658072|NCT01574716|3051751|Superiority||Hazard Ratio (HR)|1.08|||=|0|2-Sided|95.0|0.77|1.5|||Log Rank|Two-sided log-rank test|Based on Cox PH model||
1658073|NCT01574703|3051752|Superiority or Other||Risk Difference (RD)|-0.16||||0.8841|2-Sided|95.0|-2.32|2.0||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.|
1658074|NCT01574703|3051752|Superiority or Other||Risk Difference (RD)|0.11||||0.9218|2-Sided|95.0|-2.04|2.25||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.|
1658075|NCT01574703|3051752|Superiority or Other||Risk Difference (RD)|0.27||||0.8127|2-Sided|95.0|-1.95|2.49||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.|
1658076|NCT01574703|3051752|Superiority or Other||Risk Difference (RD)|-0.48||||0.6804|2-Sided|95.0|-2.75|1.8||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.|
1658077|NCT01574703|3051752|Superiority or Other||Risk Difference (RD)|-0.32||||0.7895|2-Sided|95.0|-2.65|2.01||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.|
1658078|NCT01574703|3051752|Superiority or Other||Risk Difference (RD)|-0.59||||0.6105|2-Sided|95.0|-2.84|1.67||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.|
1658079|NCT01574703|3051753|Superiority or Other||Risk Difference (RD)|-0.3||||0.8262|2-Sided|95.0|-2.99|2.39||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.|
1658080|NCT01574703|3051753|Superiority or Other||Risk Difference (RD)|-0.08||||0.9531|2-Sided|95.0|-2.63|2.48||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.|
1658081|NCT01574703|3051753|Superiority or Other||Risk Difference (RD)|0.22||||0.8707|2-Sided|95.0|-2.48|2.93||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.|
1658082|NCT01574703|3051753|Superiority or Other||Risk Difference (RD)|-0.99||||0.6109|2-Sided|95.0|-4.8|2.82||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.|
1658127|NCT01573767|3051803|Superiority or Other||Mean Difference (Final Values)|7.8|||||2-Sided|95.0|-1.8|17.4|||||||
1658083|NCT01574703|3051753|Superiority or Other||Risk Difference (RD)|-0.69||||0.7327|2-Sided|95.0|-4.63|3.26||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.|
1658084|NCT01574703|3051753|Superiority or Other||Risk Difference (RD)|-0.91||||0.6441|2-Sided|95.0|-4.78|2.96||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.|
1658085|NCT01574703|3051754|Superiority or Other||Risk Difference (RD)|-0.37||||0.8022|2-Sided|95.0|-3.23|2.5||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.|
1658086|NCT01574703|3051754|Superiority or Other||Risk Difference (RD)|-0.39||||0.7631|2-Sided|95.0|-2.92|2.14||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.|
1658087|NCT01574703|3051754|Superiority or Other||Risk Difference (RD)|-0.02||||0.9886|2-Sided|95.0|-3.32|3.27||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.|
1658088|NCT01574703|3051754|Superiority or Other||Risk Difference (RD)|-0.6||||0.671|2-Sided|95.0|-3.35|2.15||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.|
1658089|NCT01574703|3051754|Superiority or Other||Risk Difference (RD)|-0.23||||0.8747|2-Sided|95.0|-3.09|2.63||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.|
1658090|NCT01574703|3051754|Superiority or Other||Risk Difference (RD)|-0.21||||0.8932|2-Sided|95.0|-3.22|2.81||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.|
1658091|NCT01574703|3051755|Superiority or Other||Risk Difference (RD)|-0.42||||0.8201|2-Sided|95.0|-4.01|3.17||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.|
1658092|NCT01574703|3051755|Superiority or Other||Risk Difference (RD)|-0.62||||0.7236|2-Sided|95.0|-4.09|2.84||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.|
1658093|NCT01574703|3051755|Superiority or Other||Risk Difference (RD)|-0.21||||0.92|2-Sided|95.0|-4.27|3.85||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.|
1658094|NCT01574703|3051755|Superiority or Other||Risk Difference (RD)|-1.2||||0.5946|2-Sided|95.0|-5.6|3.21||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.|
1658095|NCT01574703|3051755|Superiority or Other||Risk Difference (RD)|-0.78||||0.7303|2-Sided|95.0|-5.21|3.65||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.|
1658096|NCT01574703|3051755|Superiority or Other||Risk Difference (RD)|-0.57||||0.8117|2-Sided|95.0|-5.27|4.13||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.|
1658097|NCT01574703|3051756|Superiority or Other||Risk Difference (RD)|-0.77||||0.7113|2-Sided|95.0|-4.85|3.31||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.|
1658098|NCT01574703|3051756|Superiority or Other||Risk Difference (RD)|-0.14||||0.926|2-Sided|95.0|-3.13|2.85||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.|
1658099|NCT01574703|3051756|Superiority or Other||Risk Difference (RD)|0.63||||0.7767|2-Sided|95.0|-3.72|4.98||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.|
1658100|NCT01574703|3051756|Superiority or Other||Risk Difference (RD)|-0.21||||0.8962|2-Sided|95.0|-3.36|2.94||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.|
1658128|NCT01573767|3051803|Superiority or Other||Mean Difference (Final Values)|3.5|||||2-Sided|95.0|-6.1|13.1|||||||
1658129|NCT01573767|3051804|Superiority or Other||Mean Difference (Final Values)|7.2||||||95.0|0.4|14.0|||||||
1658101|NCT01574703|3051756|Superiority or Other||Risk Difference (RD)|0.56||||0.7905|2-Sided|95.0|-3.58|4.7||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.|
1658102|NCT01574703|3051756|Superiority or Other||Risk Difference (RD)|-0.07||||0.9687|2-Sided|95.0|-3.48|3.34||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.|
1658103|NCT01574703|3051757|Superiority or Other||Risk Difference (RD)|-1.06||||0.6322|2-Sided|95.0|-5.41|3.28||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between NRT patch and Placebo.|
1658104|NCT01574703|3051757|Superiority or Other||Risk Difference (RD)|-0.64||||0.7217|2-Sided|95.0|-4.15|2.88||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and Placebo.|
1658105|NCT01574703|3051757|Superiority or Other||Risk Difference (RD)|0.42||||0.8602|2-Sided|95.0|-4.28|5.13||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Bupropion and NRT patch.|
1658106|NCT01574703|3051757|Superiority or Other||Risk Difference (RD)|-1.13||||0.6142|2-Sided|95.0|-5.54|3.27||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Placebo.|
1658107|NCT01574703|3051757|Superiority or Other||Risk Difference (RD)|-0.07||||0.978|2-Sided|95.0|-5.2|5.05||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and NRT patch.|
1658108|NCT01574703|3051757|Superiority or Other||Risk Difference (RD)|-0.49||||0.8375|2-Sided|95.0|-5.22|4.23||P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.|Regression, Logistic|||Statistical analysis between Varenicline and Bupropion.|
1658109|NCT01574703|3051758|Superiority or Other|||||||0.34||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.|
1658110|NCT01574703|3051759|Superiority or Other|||||||0.53||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.|
1658111|NCT01574703|3051760|Superiority or Other|||||||0.37||||||P-value for the treatment effect from the Log-Rank test stratified by Cohort.|Log Rank|||Statistical analysis for overall treatment comparison.|
1658112|NCT01574326|3051773|Superiority or Other||Least square (LS) mean difference|-0.9||||0.001|2-Sided|95.0|-1.44|-0.37|||ANCOVA|Threshold for significance ≤ 0.05.||Primary efficacy endpoint, change from baseline to Week 2 in serum phosphorus, was compared between treatment groups using analysis of covariance (ANCOVA) with baseline phosphorus and screening BSA as covariates and fixed effect for treatment. No center effect was included in the model. The estimate of the treatment difference (Sevelamer Carbonate - Placebo) and its 95% CI were presented. Significance was to be declared if the p-value was ≤0.05.|
1658113|NCT01574157|3051786|Superiority||Mean Difference (Final Values)|3.37|||||2-Sided|95.0|-0.05|6.79||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.|
1658114|NCT01574157|3051787|Superiority||Mean Difference (Final Values)|1.2|||||2-Sided|95.0|-24.6|35.9||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.|
1658115|NCT01574157|3051788|Superiority||Mean Difference (Final Values)|7.7|||||2-Sided|95.0|-15.1|36.5||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.|
1658116|NCT01574157|3051789|Superiority||Mean Difference (Final Values)|-32.5|||||2-Sided|95.0|-56.3|4.2||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.|
1658117|NCT01574157|3051790|Superiority||Mean Difference (Final Values)|-10.1|||||2-Sided|95.0|-38.2|30.8||||||The main analytic strategy for this secondary outcome was a comparison of the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.|
1658118|NCT01574157|3051791|Superiority||Mean Difference (Final Values)|12.6|||||2-Sided|95.0|-9.6|40.1||||||The primary analysis compared the mean change from baseline in the sodium bicarbonate group to the mean change from baseline in the placebo group.|
1658119|NCT01574105|3051795|Non-Inferiority or Equivalence|Sample sizes of 26 in heparin resistant group and 26 in heparin sensitive group achieve 90% power at the 0.025 level of significance to detect a non-inferiority using a one-sided two-sample t-test, assuming a noninferiority margin is 200 milliliters in the postoperative chest tube loss.|||||<|0.1|||||||ANCOVA|||For the analysis of the patient characteristics Wilcoxon, Chi-square and Fischer’s exact tests were used. An upper bound of a two-sided 95% confidence interval (CI) of the mean difference between resistant and sensitive groups for all values of chest tube losses was computed by analysis of covariance (ANCOVA), and compared with pre-specified noninferiority limits. Covariates in the ANCOVA model included patient characteristics differing between two groups with a p-value <0.1.|
1658120|NCT01573767|3051801|Superiority or Other||Mean Difference (Final Values)|9.8|||||2-Sided|95.0|2.3|17.2|||||||
1658121|NCT01573767|3051801|Superiority or Other||Mean Difference (Final Values)|8.3|||||2-Sided|95.0|1.0|15.7|||||||
1658131|NCT01573767|3051804|Superiority or Other||Mean Difference (Final Values)|5.5|||||2-Sided|95.0|-1.2|12.3|||||||
1658132|NCT01573767|3051805|Superiority or Other||Mean Difference (Final Values)|8.7|||||2-Sided|95.0|0.4|17.0|||||||
1658133|NCT01573767|3051805|Superiority or Other||Mean Difference (Final Values)|1.3|||||2-Sided|95.0|-6.9|9.6|||||||
1658134|NCT01573767|3051805|Superiority or Other||Mean Difference (Final Values)|-2.3|||||2-Sided|95.0|-10.5|6.0|||||||
1658135|NCT01573767|3051806|Superiority or Other||Mean Difference (Final Values)|-0.03|||||2-Sided|95.0|-0.11|0.051|||||||
1658136|NCT01573767|3051806|Superiority or Other||Mean Difference (Final Values)|0.017|||||2-Sided|95.0|-0.063|0.096|||||||
1658137|NCT01573767|3051806|Superiority or Other||Mean Difference (Final Values)|-0.057|||||2-Sided|95.0|-0.138|0.024|||||||
1658138|NCT01573767|3051807|Superiority or Other||Mean Difference (Final Values)|5.5||||0.127|2-Sided|95.0|-1.6|12.5|||ANCOVA||||
1658139|NCT01573767|3051807|Superiority or Other||Mean Difference (Final Values)|6.4||||0.073|2-Sided|95.0|-0.6|13.5|||ANCOVA||||
1658140|NCT01573767|3051807|Superiority or Other||Mean Difference (Final Values)|4.4||||0.227|2-Sided|95.0|-2.7|11.4||Inference for VI 12.5 µg versus (vs) placebo was dependent upon statistical significance (SS) having first been achieved for VI 25 µg vs placebo; inference for VI 6.25 µg vs placebo was dependent on SS having been achieved for VI 12.5 µg vs placebo.|ANCOVA||||
1658141|NCT01573624|3051808|Superiority or Other||Mean Difference (Net)|0.2||||0.143|2-Sided|95.0|-0.1|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658142|NCT01573624|3051808|Superiority or Other||Mean Difference (Net)|0.1||||0.217|2-Sided|95.0|-0.1|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658143|NCT01573624|3051808|Superiority or Other||Mean Difference (Net)|0.3||||0.006|2-Sided|95.0|0.1|0.6|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658144|NCT01573624|3051808|Superiority or Other||Mean Difference (Net)|0.2||||0.062|2-Sided|95.0|0.0|0.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658145|NCT01573624|3051808|Superiority or Other||Mean Difference (Net)|0.2||||0.104|2-Sided|95.0|0.0|0.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658146|NCT01573624|3051808|Superiority or Other||Mean Difference (Net)|-0.4|||<|0.001|2-Sided|95.0|-0.7|-0.2|||Mixed Models Analysis||||
1658147|NCT01573624|3051808|Superiority or Other||Mean Difference (Net)|-0.3|||<|0.023|2-Sided|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658148|NCT01573624|3051808|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.012|2-Sided|95.0|-0.5|-0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658149|NCT01573624|3051808|Superiority or Other||Mean Difference (Net)|-0.1|||<|0.335|2-Sided|95.0|-0.3|0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658150|NCT01573624|3051808|Superiority or Other||Mean Difference (Net)|-0.2|||<|0.064|2-Sided|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658151|NCT01573624|3051808|Superiority or Other||Mean Difference (Net)|-0.2|||<|0.036|2-Sided|95.0|-0.5|0.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658152|NCT01573624|3051809|Superiority or Other||Mean Difference (Net)|-3.7||||0.29|2-Sided|95.0|-10.5|3.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658153|NCT01573624|3051809|Superiority or Other||Mean Difference (Net)|2.2||||0.523||95.0|-4.6|9.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658154|NCT01573624|3051809|Superiority or Other||Mean Difference (Net)|-5.4||||0.126|2-Sided|95.0|-12.3|1.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658155|NCT01573624|3051809|Superiority or Other||Mean Difference (Net)|-9.3||||0.007|2-Sided|95.0|-16.2|-2.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658156|NCT01573624|3051809|Superiority or Other||Mean Difference (Net)|-10.3||||0.003|2-Sided|95.0|-17.2|-3.5|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658157|NCT01573624|3051809|Superiority or Other||Mean Difference (Net)|26.6|||<|0.001|2-Sided|95.0|19.8|33.4|||Mixed Models Analysis||||
1658158|NCT01573624|3051809|Superiority or Other||Mean Difference (Net)|22.9|||<|0.001|2-Sided|95.0|16.2|29.6|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658159|NCT01573624|3051809|Superiority or Other||Mean Difference (Net)|28.8|||<|0.001|2-Sided|95.0|22.1|35.5|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658160|NCT01573624|3051809|Superiority or Other||Mean Difference (Net)|21.2|||<|0.001|2-Sided|95.0|14.4|28.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658161|NCT01573624|3051809|Superiority or Other||Mean Difference (Net)|17.2|||<|0.001|2-Sided|95.0|10.5|24.0|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658162|NCT01573624|3051809|Superiority or Other||Mean Difference (Net)|16.2|||<|0.001|2-Sided|95.0|9.5|22.9|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658163|NCT01573624|3051810|Superiority or Other||Mean Difference (Net)|-5.1||||0.124|2-Sided|95.0|-11.6|1.4|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658164|NCT01573624|3051810|Superiority or Other||Mean Difference (Net)|-4.1||||0.209|2-Sided|95.0|-10.6|2.3|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658165|NCT01573624|3051810|Superiority or Other||Mean Difference (Net)|-8.4||||0.012|2-Sided|95.0|-14.9|-1.9|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658166|NCT01573624|3051810|Superiority or Other||Mean Difference (Net)|-9.6||||0.004|2-Sided|95.0|-16.1|-3.1|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658167|NCT01573624|3051810|Superiority or Other||Mean Difference (Net)|-11.2|||<|0.001|2-Sided|95.0|-17.6|-4.7|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658168|NCT01573624|3051810|Superiority or Other||Mean Difference (Net)|27.0|||<|0.001|2-Sided|95.0|20.6|33.5|||Mixed Models Analysis||||
1658169|NCT01573624|3051810|Superiority or Other||Mean Difference (Final Values)|22.0|||<|0.001|2-Sided|95.0|15.5|28.4|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658170|NCT01573624|3051810|Superiority or Other||Mean Difference (Net)|22.9|||<|0.001|2-Sided|95.0|16.5|29.4|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658171|NCT01573624|3051810|Superiority or Other||Mean Difference (Final Values)|18.6|||<|0.001|2-Sided|95.0|12.1|25.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658172|NCT01573624|3051810|Superiority or Other||Mean Difference (Net)|17.4|||<|0.001|2-Sided|95.0|10.9|23.9|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658206|NCT01573000|3051861|Superiority or Other||percentage of participants|32.0|||||2-Sided|95.0|11.0|52.0|||||The estimated value represents the percentage of participants with confirmed PR after Crossover.||
1658207|NCT01573000|3051861|Superiority or Other||percentage of participants|16.0|||||2-Sided|95.0|0.0|32.0|||||The estimated value represents the percentage of participants with confirmed PR before Crossover.||
1658173|NCT01573624|3051810|Superiority or Other||Mean Difference (Net)|15.9|||<|0.001|2-Sided|95.0|9.5|22.3|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658174|NCT01573624|3051811|Superiority or Other||Mean Difference (Net)|-0.023||||0.33|2-Sided|95.0|-0.068|0.023|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658175|NCT01573624|3051811|Superiority or Other||Mean Difference (Final Values)|-0.023||||0.306|2-Sided|95.0|-0.068|0.021|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658176|NCT01573624|3051811|Superiority or Other||Mean Difference (Net)|-0.053||||0.023|2-Sided|95.0|-0.098|-0.007|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658177|NCT01573624|3051811|Superiority or Other||Mean Difference (Net)|-0.045||||0.051|2-Sided|95.0|-0.091|0.0|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658178|NCT01573624|3051811|Superiority or Other||Mean Difference (Net)|-0.052||||0.023|2-Sided|95.0|-0.097|-0.007|||Mixed Models Analysis|||No adjustments were made for comparisons between doses of FF + UMEC and FF + VI.|
1658179|NCT01573624|3051811|Superiority or Other||Mean Difference (Net)|0.078|||<|0.001|2-Sided|95.0|0.032|0.124|||Mixed Models Analysis||||
1658180|NCT01573624|3051811|Superiority or Other||Mean Difference (Net)|0.055|||<|0.018|2-Sided|95.0|0.01|0.101|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658181|NCT01573624|3051811|Superiority or Other||Mean Difference (Net)|0.055|||<|0.018|2-Sided|95.0|0.01|0.1|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658182|NCT01573624|3051811|Superiority or Other||Mean Difference (Net)|0.026|||<|0.271|2-Sided|95.0|-0.02|0.071|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658183|NCT01573624|3051811|Superiority or Other||Mean Difference (Net)|0.033|||<|0.165|2-Sided|95.0|-0.013|0.079|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658184|NCT01573624|3051811|Superiority or Other||Mean Difference (Net)|0.026|||<|0.264|2-Sided|95.0|-0.019|0.071|||Mixed Models Analysis|||No pairwise comparisons between doses of FF + UMEC and FF alone were done unless overall F-test for treatment effect was statistically significant at 5% level. Multiplicity across these comparisons was controlled using a step-down closed testing procedure, whereby statistical comparison of the highest dose of FF + UMEC and FF alone was initially performed, and subsequent comparisons at lower doses continued in a step-down manner if preceding comparison was statistically significant at 5% level.|
1658185|NCT01573533|3051815|Superiority|||||||0.06|||||||ANOVA|||Baseline vs 12 months|
1658186|NCT01573533|3051816|Superiority|||||||0.41|||||||ANOVA|||Baseline vs 12 months|
1658187|NCT01573533|3051817|Superiority|||||||0.49|||||||ANOVA|||Baseline vs 12 months|
1658188|NCT01573442|3051818|Superiority|||||||0.9609|||||||Wilcoxon (Mann-Whitney)||||
1658189|NCT01573442|3051819|Superiority|||||||0.7694|||||||Wilcoxon (Mann-Whitney)||||
1658190|NCT01573442|3051820|Superiority|||||||0.286|||||||Wilcoxon (Mann-Whitney)||||
1658191|NCT01573442|3051821|Superiority|||||||0.4335|||||||Wilcoxon (Mann-Whitney)||||
1658192|NCT01573442|3051822|Superiority|||||||0.8748|||||||Wilcoxon (Mann-Whitney)||||
1658193|NCT01573442|3051823|Superiority|||||||0.7077|||||||Wilcoxon (Mann-Whitney)||||
1658194|NCT01573442|3051824|Superiority|||||||0.0176|||||||Wilcoxon (Mann-Whitney)||||
1658195|NCT01573442|3051825|Superiority|||||||0.8761|||||||Wilcoxon (Mann-Whitney)||||
1658196|NCT01573442|3051826|Superiority|||||||0.139|||||||Wilcoxon (Mann-Whitney)||||
1658197|NCT01573442|3051830|Superiority|||||||0.7005|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 6|
1658198|NCT01573442|3051830|Superiority|||||||0.5522|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 5|
1658199|NCT01573442|3051830|Superiority|||||||0.5232|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 4|
1658200|NCT01573442|3051830|Superiority|||||||0.4952|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 3|
1658201|NCT01573442|3051830|Superiority|||||||0.8214|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 2|
1658202|NCT01573442|3051830|Superiority|||||||0.029|||||||Wilcoxon (Mann-Whitney)|||From baseline to month 1|
1658203|NCT01573442|3051831|Superiority|||||||0.676|||||||Wilcoxon (Mann-Whitney)||||
1658204|NCT01573442|3051832|Superiority|||||||0.2116|||||||Fisher Exact||||
1658205|NCT01573442|3051833|Superiority|||||||0.4952|||||||Wilcoxon (Mann-Whitney)||||
1658209|NCT01573000|3051875|Superiority or Other|||||||0.119|||||||Log Rank||||
1658210|NCT01573000|3051878|Superiority or Other|||||||0.677|||||||Log Rank||||
1658211|NCT01573000|3051879|Superiority or Other|||||||0.495|||||||Log Rank||||
1658212|NCT01573000|3051881|Superiority or Other|||||||0.001|||||||Fisher Exact||||
1658213|NCT01573000|3051882|Superiority or Other||percentage of participants|11.0|||||2-Sided|95.0|1.0|21.0|||||The estimated value represents the percentage of participants with confirmed PR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.||
1658214|NCT01573000|3051882|Superiority or Other||percentage of participants|17.0|||||2-Sided|95.0|5.0|28.0|||||The estimated value represents the percentage of participants with confirmed PR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.||
1658215|NCT01573000|3051883|Superiority or Other||percentage of participants|47.0|||||2-Sided|95.0|25.0|70.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR after Crossover.||
1658216|NCT01573000|3051883|Superiority or Other||percentage of participants|0.0|||||2-Sided|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR before Crossover.||
1658217|NCT01573000|3051884|Superiority or Other||percentage of participants|11.0|||||2-Sided|95.0|1.0|21.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.||
1658218|NCT01573000|3051884|Superiority or Other||percentage of participants|31.0|||||2-Sided|95.0|17.0|45.0|||||The estimated value represents the percentage of participants with confirmed CR and CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.||
1658219|NCT01573000|3051885|Superiority or Other||percentage of participants|5.0|||||2-Sided|95.0|0.0|15.0|||||The estimated value represents the percentage of participants with confirmed CCR after Crossover.||
1658220|NCT01573000|3051885|Superiority or Other||percentage of participants|0.0|||||2-Sided|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed CCR before Crossover.||
1658221|NCT01573000|3051886|Superiority or Other||percentage of participants|3.0|||||2-Sided|95.0|0.0|8.0|||||The estimated value represents the percentage of participants with confirmed CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.||
1658222|NCT01573000|3051886|Superiority or Other||percentage of participants|2.0|||||2-Sided|95.0|0.0|7.0|||||The estimated value represents the percentage of participants with confirmed CCR. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.||
1658223|NCT01573000|3051887|Superiority or Other||percentage of participants|42.0|||||2-Sided|95.0|20.0|64.0|||||The estimated value represents the percentage of participants with confirmed complete response after Crossover.||
1658224|NCT01573000|3051887|Superiority or Other||percentage of participants|0.0|||||2-Sided|95.0|0.0|0.0|||||The estimated value represents the percentage of participants with confirmed complete response before Crossover.||
1658225|NCT01573000|3051888|Superiority or Other|||||||0.012|||||||Fisher Exact||||
1658226|NCT01573000|3051889|Superiority or Other||percentage of participants|8.0|||||2-Sided|95.0|0.0|17.0|||||The estimated value represents the percentage of participants with complete response. The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.||
1658227|NCT01573000|3051889|Superiority or Other||percentage of participants|26.0|||||2-Sided|95.0|13.0|39.0|||||The estimated value represents the percentage of participants with complete response. The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.||
1658228|NCT01573000|3051890|Superiority or Other||percentage of participants|79.0|||||2-Sided|95.0|61.0|97.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR) after Crossover.||
1658229|NCT01573000|3051890|Superiority or Other||percentage of participants|16.0|||||2-Sided|95.0|0.0|32.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR) before Crossover.||
1658230|NCT01573000|3051891|Superiority or Other||percentage of participants|22.0|||||2-Sided|95.0|9.0|36.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR). The number of participants evaluable for overall response (confirmed and unconfirmed; n=36) is used as the denominator.||
1658231|NCT01573000|3051891|Superiority or Other||percentage of participants|50.0|||||2-Sided|95.0|35.0|65.0|||||The estimated value represents the percentage of participants with confirmed response (CR, CCR, PR). The number of participants evaluable for overall response (confirmed and unconfirmed; n=42) is used as the denominator.||
1658232|NCT01572740|3051920|Superiority or Other||Estimated treatment difference, Mean|-0.35||||0.2074||95.0|-0.91|0.2|||ANCOVA||||
1658233|NCT01572740|3051921|Superiority or Other||Estimated treatment difference, Mean|-0.14||||0.4806||95.0|-0.54|0.25|||ANCOVA||||
1658234|NCT01572740|3051922|Superiority or Other||Estimated treatment difference, Mean|-0.39||||0.1787||95.0|-0.97|0.18|||ANCOVA||||
1658235|NCT01572740|3051923|Superiority or Other||Estimated treatment difference, Mean|-0.73||||0.0023||95.0|-1.2|-0.26|||ANCOVA||||
1658236|NCT01572740|3051924|Superiority or Other||Estimated treatment difference, Mean|-1.28|||<|0.0001||95.0|-1.73|-0.83|||ANCOVA||||
1658237|NCT01572740|3051925|Superiority or Other||Estimated treatment difference, Mean|-1.87|||<|0.0001||95.0|-2.37|-1.38|||ANCOVA||||
1658238|NCT01572740|3051926|Superiority or Other||Estimated treatment difference, Mean|-0.26||||0.2511||95.0|-0.7|0.18|||ANCOVA||||
1658239|NCT01572740|3051927|Superiority or Other||Estimated treatment difference, Mean|-0.83|||<|0.0006||95.0|-1.3|-0.36|||ANCOVA||||
1658240|NCT01572740|3051928|Superiority or Other||Estimated treatment difference, Mean|-0.81|||<|0.0001||95.0|-0.99|-0.63|||ANCOVA||||
1658241|NCT01572740|3051929|Superiority or Other||Estimated treatment difference, Mean|-1.3|||<|0.0001||95.0|-1.47|-1.13|||ANCOVA||||
1658242|NCT01572727|3051937|Superiority or Other||Hazard Ratio (HR)|1.18|||||2-Sided|95.0|0.82|1.68|||||||
1658243|NCT01572675|3051939|Superiority or Other|||||||0.165|||||||Chi-squared|||Group comparsion (Arcoxia® vs Celebrex®) of adverse events experienced during treatment|
1658244|NCT01572675|3051942|Superiority or Other|||||||0.049|||||||Fisher Exact|||Group comparsion (Arcoxia® vs Celebrex®) for previous treatment with other agents prior to initiation of Arcoxia® and Celebrex® for the main study indications|
1658245|NCT01572675|3051945|Superiority or Other|||||||0.955|||||||Chi-squared|||Group comparison (Arcoxia® vs Celebrex®) for significant past treatments|
1658246|NCT01572675|3051945|Superiority or Other|||||||0.007|||||||Chi-squared|||Group comparison (Celebrex® [Initiation] vs Celebrex® [Renewal]) for significant past treatments|
1658247|NCT01572675|3051945|Superiority or Other|||||||0.701|||||||Chi-squared|||Group comparison (Arcoxia® [Initiation] vs Arcoxia® [Renewal]) for significant past treatments|
1658248|NCT01572675|3051947|Superiority or Other|||||||0.175|||||||Chi-squared|||Group comparison (Celebrex® [Initiation] vs Celebrex® [Renewal]) for medical history of arterial hypertension|
1658249|NCT01572675|3051947|Superiority or Other|||||||0.012|||||||Chi-squared|||Group comparison (Arcoxia® [Initiation] vs Arcoxia® [Renewal]) for medical history of arterial hypertension|
1658250|NCT01572675|3051948|Superiority or Other|||||||0.618|||||||Chi-squared|||Group comparison (Celebrex® [Initiation] vs Celebrex® [Renewal]) for controlled BP (SBP <140 mmHg and DBP <90 mmHg) at study entry|
1658251|NCT01572675|3051948|Superiority or Other|||||||0.0049|||||||Chi-squared|||Group comparison (Arcoxia® [Initiation] vs Arcoxia® [Renewal]) for controlled BP (SBP <140 mmHg and DBP <90 mmHg) at study entry|
1658252|NCT01572675|3051948|Superiority or Other|||||||0.104|||||||Chi-squared|||Group comparison (Arcoxia® vs Celebrex®) for controlled BP (SBP <140 mmHg and DBP <90 mmHg) at study entry|
1658253|NCT01572675|3051951|Superiority or Other||||||<|0.001|||||||Chi-squared|||Duration of treatment comparison (More than one year vs Up to thirty days) for intermittent selective COX-2 inhibitor use. The analysis assessed whether long-term treatment was more correlated with intermittent selective COX-2 inhibitor use compared to short-term treatment.|
1658254|NCT01572675|3051956|Superiority or Other||||||<|0.001|||||||p-student|||Group comparison (Celebrex® [Initiation] vs Celebrex® [Renewal]) for duration of prescription at enrollment|
1658255|NCT01572675|3051956|Superiority or Other||||||<|0.001|||||||p-student|||Group comparison (Arcoxia® [Initiation] vs Arcoxia® [Renewal]) for duration of prescription at enrollment|
1658256|NCT01571453|3051981|Superiority or Other||Odds Ratio (OR)|1.07||||0.731||95.0|0.73|1.58||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic||||
1658257|NCT01571453|3051982|Superiority or Other||Odds Ratio (OR)|1.25||||0.272||95.0|0.84|1.86||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic||||
1658258|NCT01571453|3051983|Superiority or Other||Mean Difference (Final Values)|-0.82|Standard Error of the Mean|0.65||0.207|2-Sided|95.0|-2.09|0.45||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.|
1658259|NCT01571453|3051984|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.11||0.174|2-Sided|95.0|-0.35|0.06||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.|
1658260|NCT01571453|3051985|Superiority or Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.12||0.228|2-Sided|95.0|-0.39|0.09||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The same ANCOVA methodology as for the primary endpoint was used.|
1658261|NCT01571453|3051986|Non-Inferiority or Equivalence|Vortioxetine was declared to be non-inferior to venlafaxine if the upper limit of the calculated two-sided 95% confidence interval for the treatment difference at Week 8 between vortioxetine and venlafaxine was less than +2.5 MADRS units versus venlafaxine.|Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.93||0.199||95.0|-3.03|0.63||No adjustments for multiple comparisons were made.|ANCOVA|LOCF was used.||The sample size calculation was based on a non-inferiority comparison of the treatment groups in the change from baseline to Week 8 in MADRS total score using a two-sided 95% CI against a margin of +2.5 points. Assuming a standard deviation of 9.0 points and an expected true mean difference between treatments of 0 points, a total of 410 patients (205 per treatment group) were needed to provide a power of 80% for correctly concluding non-inferiority.|
1658262|NCT01571427|3051987|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.15||0.12|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)|
1658263|NCT01571427|3051987|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.1||0.75|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)|
1658264|NCT01571427|3051987|Equivalence|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.09||0.3|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).||
1658265|NCT01571427|3051988|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.08||0.4|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)|
1658311|NCT01571362|3052031|Superiority or Other||Mean Difference (Net)|1.0|Standard Error of the Mean|2.684||0.7109|2-Sided|95.0|-4.3|6.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8|
1658266|NCT01571427|3051988|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.004|Standard Error of the Mean|0.05||0.93|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)|
1658267|NCT01571427|3051988|Equivalence|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.45||0.45|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).||
1658268|NCT01571427|3051989|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.1||0.42|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)|
1658269|NCT01571427|3051989|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.05||0.64|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)|
1658270|NCT01571427|3051989|Equivalence|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.05||0.65|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).||
1658271|NCT01571427|3051990|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.04||0.04|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)|
1658272|NCT01571427|3051990|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.03||0.24|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)|
1658273|NCT01571427|3051990|Equivalence|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.02||0.03|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).||
1658274|NCT01571427|3051991|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.68|Standard Error of the Mean|1.26||0.59|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)|
1658275|NCT01571427|3051991|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.12|Standard Error of the Mean|1.31||0.39|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)|
1658276|NCT01571427|3051991|Equivalence|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.81|Standard Error of the Mean|0.91||0.38|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).||
1658277|NCT01571427|3051992|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|12.39|Standard Error of the Mean|14.4||0.4|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)|
1658278|NCT01571427|3051992|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|2.26|Standard Error of the Mean|11.1||0.84|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)|
1658453|NCT01571362|3052096|Superiority or Other|||||||0.021|||||||Cochran-Mantel-Haenszel|CMH was stratified by prior pain analgesic (opioid and non-opioid).|||
1658510|NCT01569451|3052271|Superiority or Other|||||||0.0493|||||||Chi-squared||||
1658279|NCT01571427|3051992|Equivalence|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|3.25|Standard Error of the Mean|8.88||0.72|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).||
1658280|NCT01571427|3051993|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.66|Standard Error of the Mean|6.42||0.8|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)|
1658281|NCT01571427|3051993|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-1.07|Standard Error of the Mean|2.08||0.61|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)|
1658282|NCT01571427|3051993|Equivalence|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-2.11|Standard Error of the Mean|2.84||0.46|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).||
1658283|NCT01571427|3051994|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.62||0.94|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)|
1658284|NCT01571427|3051994|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.61||0.92|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)|
1658285|NCT01571427|3051994|Equivalence|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.43||0.92|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).||
1658286|NCT01571427|3051995|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.18|Standard Error of the Mean|1.02||0.86|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: CDR 0.5 (n=34)|
1658287|NCT01571427|3051995|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.34|Standard Error of the Mean|0.84||0.69|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: CDR 0 (n=49)|
1658288|NCT01571427|3051995|Equivalence|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.64||0.68|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).||
1658289|NCT01571427|3051996|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.51|Standard Error of the Mean|2.38||0.83|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 3: Among CDR 0.5 (n=34)|
1658290|NCT01571427|3051996|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|-0.09|Standard Error of the Mean|1.63||0.96|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: Among CDR 0 (n=49)|
1658291|NCT01571427|3051996|Equivalence|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|0.03|Standard Error of the Mean|1.33||0.98|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).||
1658454|NCT01571362|3052097|Superiority or Other|||||||0.1272|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) stratified by prior pain analgesic (opioid or non-opioid)|||
1658292|NCT01571427|3051997|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|0.52|Standard Error of the Mean|1.14||0.65|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analyses 3: CDR=0.5 (Mild Cognitive Impairment) group, N=34|
1658293|NCT01571427|3051997|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses by each CDR group are exploratory.|Mean Difference (Final Values)|4.0|Standard Error of the Mean|1.28||0.003|2-Sided|||||Statistically significant based on the Bonferroni multiple comparison adjusted P value of P<0.004.|Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: AMONG CDR=0 group (N=49)|
1658294|NCT01571427|3051997|Equivalence|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|2.2|Standard Error of the Mean|0.92||0.02|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).||
1658295|NCT01571427|3051998|Equivalence|Power calculation was based on the entire sample which combined CDR=0 and CDR=0.5 groups. Analyses within each CDR group are exploratory.|Median Difference (Final Values)|-0.11|Standard Error of the Mean|0.62||0.85|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analyses 3: AMONG CDR=0.5 (Mild Cognitive Impairment) group, N=34 .|
1658296|NCT01571427|3051998|Equivalence|Power calculation was based on the entire sample (CDR=0 and CDR=0.5 combined). Analyses within each CDR group are exploratory.|Median Difference (Final Values)|-0.49|Standard Error of the Mean|0.42||0.25|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).|Analysis 2: AMONG CDR=0 group (N=49)|
1658297|NCT01571427|3051998|Equivalence|It was calculated that 82 participants randomized in a 1:1 fashion between the 2 arms would have at least 80% to detect a Cohen's D of 0.45 in the difference in changes from baseline to week 6 at alpha=0.05 (two tailed). All randomized participants (n=83) were included in the analysis.|Mean Difference (Final Values)|-0.41|Standard Error of the Mean|0.35||0.25|2-Sided||||||Regression, Linear||Estimates reported here is coefficient for the experimental group (with the control group as a reference), using a linear regression model controlling for Geriatric Depression Scale - 15 items version (GDS-15).||
1658298|NCT01571362|3052027|Superiority or Other||Mean Difference (Net)|-8.19|Standard Error of the Mean|2.818||0.004|2-Sided|95.0|-13.74|-2.64||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET|
1658299|NCT01571362|3052027|Superiority or Other||Mean Difference (Net)|-4.62|Standard Error of the Mean|2.999||0.1249|2-Sided|95.0|-10.54|1.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8|
1658300|NCT01571362|3052027|Superiority or Other||Mean Difference (Net)|-7.5|Standard Error of the Mean|2.654||0.0052|2-Sided|95.0|-12.72|-2.27||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4|
1658301|NCT01571362|3052028|Superiority or Other||Mean Difference (Net)|-10.35|Standard Error of the Mean|5.589||0.0679|2-Sided|95.0|-21.47|0.78||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET|
1658302|NCT01571362|3052028|Superiority or Other||Mean Difference (Net)|-14.16|Standard Error of the Mean|5.998||0.0219|2-Sided|95.0|-26.19|-2.14||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8|
1658303|NCT01571362|3052028|Superiority or Other||Mean Difference (Net)|-12.56|Standard Error of the Mean|5.168||0.0177|2-Sided|95.0|-22.87|-2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4|
1658304|NCT01571362|3052029|Superiority or Other||Mean Difference (Net)|-9.2|Standard Error of the Mean|4.785||0.0581|2-Sided|95.0|-18.72|0.32||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET|
1658305|NCT01571362|3052029|Superiority or Other||Mean Difference (Net)|-12.94|Standard Error of the Mean|5.336||0.0186|2-Sided|95.0|-23.63|-2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8|
1658306|NCT01571362|3052029|Superiority or Other||Mean Difference (Net)|-12.38|Standard Error of the Mean|4.666||0.0098|2-Sided|95.0|-21.68|-3.07||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4|
1658307|NCT01571362|3052030|Superiority or Other||Mean Difference (Net)|-1.09|Standard Error of the Mean|3.391||0.748|2-Sided|95.0|-7.84|5.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 12/ET|
1658308|NCT01571362|3052030|Superiority or Other||Mean Difference (Net)|-1.59|Standard Error of the Mean|3.414||0.6437|2-Sided|95.0|-8.42|5.24||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 8|
1658309|NCT01571362|3052030|Superiority or Other||Mean Difference (Net)|-4.73|Standard Error of the Mean|2.776||0.0926|2-Sided|95.0|-10.26|0.8||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Week 4|
1658310|NCT01571362|3052031|Superiority or Other||Mean Difference (Net)|-4.15|Standard Error of the Mean|2.536||0.1031|2-Sided|95.0|-9.14|0.85||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET|
1658312|NCT01571362|3052031|Superiority or Other||Mean Difference (Net)|-4.25|Standard Error of the Mean|2.389||0.0768|2-Sided|95.0|-8.95|0.46||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4|
1658313|NCT01571362|3052032|Superiority or Other||Mean Difference (Net)|-5.14|Standard Error of the Mean|5.582||0.3604|2-Sided|95.0|-16.25|5.98||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET|
1658314|NCT01571362|3052032|Superiority or Other||Mean Difference (Net)|-9.35|Standard Error of the Mean|6.496||0.1558|2-Sided|95.0|-22.38|3.68||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8|
1658315|NCT01571362|3052032|Superiority or Other||Mean Difference (Net)|-7.34|Standard Error of the Mean|4.986||0.1458|2-Sided|95.0|-17.29|2.62||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4|
1658316|NCT01571362|3052033|Superiority or Other||Mean Difference (Net)|-2.38|Standard Error of the Mean|4.532||0.6008|2-Sided|95.0|-11.41|6.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET|
1658317|NCT01571362|3052033|Superiority or Other||Mean Difference (Net)|-4.99|Standard Error of the Mean|5.288||0.3497|2-Sided|95.0|-15.6|5.62||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8|
1658318|NCT01571362|3052033|Superiority or Other||Mean Difference (Net)|-6.76|Standard Error of the Mean|4.295||0.1201|2-Sided|95.0|-15.33|1.81||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4|
1658319|NCT01571362|3052034|Superiority or Other||Mean Difference (Net)|-2.77|Standard Error of the Mean|4.043||0.4944|2-Sided|95.0|-10.81|5.26||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 12/ET|
1658320|NCT01571362|3052034|Superiority or Other||Mean Difference (Net)|-2.88|Standard Error of the Mean|4.34||0.5094|2-Sided|95.0|-11.56|5.8||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 8|
1658321|NCT01571362|3052034|Superiority or Other||Mean Difference (Net)|-4.31|Standard Error of the Mean|2.883||0.1389|2-Sided|95.0|-10.06|1.43||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Week 4|
1658322|NCT01571362|3052035|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Activity Impairment due to Low Back Pain|
1658323|NCT01571362|3052035|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Overall Work Impairment due to Low Back Pain|
1658324|NCT01571362|3052035|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Impairment while Working due to Low Back Pain|
1658325|NCT01571362|3052035|Superiority or Other||||||<|0.0017|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for % Work Time Missed due to Low Back Pain|
1658326|NCT01571362|3052036|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Activity Impairment due to Low Back Pain.|
1658327|NCT01571362|3052036|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Overall Work Impairment due to Low Back Pain.|
1658328|NCT01571362|3052036|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Impairment while Working due to Low Back Pain.|
1658329|NCT01571362|3052036|Superiority or Other||||||<|0.3822|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label for % Work Time Missed due to Low Back Pain.|
1658330|NCT01571362|3052037|Superiority or Other||Mean Difference (Net)|2.26|Standard Error of the Mean|2.048||0.2701|2-Sided|95.0|-1.77|6.3||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA||||
1658331|NCT01571362|3052038|Superiority or Other||Mean Difference (Net)|0.021|Standard Error of the Mean|0.0172||0.228|2-Sided|95.0|-0.013|0.055||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA||||
1658332|NCT01571362|3052039|Superiority or Other||Mean Difference (Net)|0.72|Standard Error of the Mean|1.999||0.7196|2-Sided|95.0|-3.22|4.66||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors; Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.|ANCOVA||||
1658333|NCT01571362|3052040|Superiority or Other||Mean Difference (Net)|0.032|Standard Error of the Mean|0.0168||0.0605|2-Sided|95.0|-0.001|0.065||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of study drug during the Titration Period as covariates.|ANCOVA||||
1658334|NCT01571362|3052041|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1658335|NCT01571362|3052042|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1658336|NCT01571362|3052043|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1658337|NCT01571362|3052044|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1658338|NCT01571362|3052045|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|1.142||0.9969|2-Sided|95.0|-2.25|2.25||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Mental Component Score.|
1658500|NCT01569451|3052261|Other|Mean difference between treatment groups.||||||0.3974|||||||t-test, 2 sided||||
1658339|NCT01571362|3052045|Superiority or Other||Mean Difference (Net)|1.67|Standard Error of the Mean|1.007||0.0989|2-Sided|95.0|-0.32|3.65||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Physical Component Score.|
1658340|NCT01571362|3052045|Superiority or Other||Mean Difference (Net)|0.37|Standard Error of the Mean|1.056||0.7259|2-Sided|95.0|-1.71|2.45||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Mental Health.|
1658341|NCT01571362|3052045|Superiority or Other||Mean Difference (Net)|0.23|Standard Error of the Mean|1.374||0.867|2-Sided|95.0|-2.48|2.94||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Role-Emotional.|
1658342|NCT01571362|3052045|Superiority or Other||Mean Difference (Net)|2.0|Standard Error of the Mean|1.08||0.0658|2-Sided|95.0|-0.13|4.12||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Social Functioning.|
1658343|NCT01571362|3052045|Superiority or Other||Mean Difference (Net)|-0.45|Standard Error of the Mean|1.117||0.6878|2-Sided|95.0|-2.65|1.75||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Vitality.|
1658344|NCT01571362|3052045|Superiority or Other||Mean Difference (Net)|-0.2|Standard Error of the Mean|0.858||0.8139|2-Sided|95.0|-1.89|1.49||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for General Health Perceptions.|
1658345|NCT01571362|3052045|Superiority or Other||Mean Difference (Net)|2.39|Standard Error of the Mean|1.047||0.0232|2-Sided|95.0|0.33|4.45||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Bodily Pain.|
1658346|NCT01571362|3052045|Superiority or Other||Mean Difference (Net)|1.1|Standard Error of the Mean|1.127||0.329|2-Sided|95.0|-1.12|3.32||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Role-Physical.|
1658347|NCT01571362|3052045|Superiority or Other||Mean Difference (Net)|1.52|Standard Error of the Mean|1.111||0.1731|2-Sided|95.0|-0.67|3.71||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariates.|ANCOVA|||Difference between treatment groups in change from Screening for Physical Functioning.|
1658348|NCT01571362|3052046|Superiority or Other||Mean Difference (Net)|-0.69|Standard Error of the Mean|1.073||0.5219|2-Sided|95.0|-2.8|1.43||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Mental Component Score.|
1658349|NCT01571362|3052046|Superiority or Other||Mean Difference (Net)|1.02|Standard Error of the Mean|0.885||0.2491|2-Sided|95.0|-0.72|2.77||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Physical Component Score.|
1658350|NCT01571362|3052046|Superiority or Other||Mean Difference (Net)|0.02|Standard Error of the Mean|0.995||0.9865|2-Sided|95.0|-1.94|1.98||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Mental Health.|
1658351|NCT01571362|3052046|Superiority or Other||Mean Difference (Net)|-0.86|Standard Error of the Mean|1.348||0.522|2-Sided|95.0|-3.52|1.79||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Role-Emotional.|
1658352|NCT01571362|3052046|Superiority or Other||Mean Difference (Net)|1.48|Standard Error of the Mean|1.044||0.1565|2-Sided|95.0|-0.57|3.54||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Social Functioning.|
1658353|NCT01571362|3052046|Superiority or Other||Mean Difference (Net)|-1.16|Standard Error of the Mean|1.091||0.2898|2-Sided|95.0|-3.3|0.99||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Vitality.|
1658354|NCT01571362|3052046|Superiority or Other||Mean Difference (Net)|-0.55|Standard Error of the Mean|0.764||0.4712|2-Sided|95.0|-2.06|0.95||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for General Health Perceptions.|
1658355|NCT01571362|3052046|Superiority or Other||Mean Difference (Net)|2.37|Standard Error of the Mean|0.914||0.01|2-Sided|95.0|0.57|4.18||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Bodily Pain.|
1658356|NCT01571362|3052046|Superiority or Other||Mean Difference (Net)|-0.03|Standard Error of the Mean|0.998||0.9733|2-Sided|95.0|-2.0|1.93||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Role-Physical.|
1658501|NCT01569451|3052262|Superiority or Other|||||||0.8677|||||||Mixed Models Analysis||||
1658502|NCT01569451|3052263|Superiority or Other|||||||0.4073|||||||Chi-squared||||
1658357|NCT01571362|3052046|Superiority or Other||Mean Difference (Net)|0.62|Standard Error of the Mean|0.952||0.5181|2-Sided|95.0|-1.26|2.49||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Difference between treatment groups in change from Randomization Baseline for Physical Functioning.|
1658358|NCT01571362|3052047|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, Mental Health, Physical Component Score, and Mental Component Score|
1658359|NCT01571362|3052048|Superiority or Other|||||||0.0026|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Mental Component Score.|
1658360|NCT01571362|3052048|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Physical Component Score.|
1658361|NCT01571362|3052048|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Mental Health.|
1658362|NCT01571362|3052048|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Role-Emotional.|
1658363|NCT01571362|3052048|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Social Functioning.|
1658364|NCT01571362|3052048|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Vitality.|
1658365|NCT01571362|3052048|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for General Health.|
1658366|NCT01571362|3052048|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Bodily Pain.|
1658367|NCT01571362|3052048|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Role-Physical.|
1658368|NCT01571362|3052048|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to End of Open-Label Titration Period for Physical Functioning.|
1658369|NCT01571362|3052049|Superiority or Other|||||||0.0004|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.|||
1658370|NCT01571362|3052052|Superiority or Other|||||||0.5767|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.|||
1658371|NCT01571362|3052053|Superiority or Other|||||||0.2211|||||||Cochran-Mantel-Haenszel|Stratified by opioid stratum.|||
1658372|NCT01571362|3052054|Superiority or Other||||||<|0.0001|||||||Bowker's test of symmetry||||
1658373|NCT01571362|3052055|Superiority or Other||||||<|0.0001|||||||Bowker's test of symmetry||||
1658374|NCT01571362|3052056|Superiority or Other||Mean Difference (Net)|0.41|Standard Error of the Mean|0.619||0.5074|2-Sided|95.0|-0.81|1.63||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted Change from Baseline to Week 8.|
1658375|NCT01571362|3052056|Superiority or Other||Mean Difference (Net)|-0.7|Standard Error of the Mean|0.577||0.2264|2-Sided|95.0|-1.84|0.44||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted Change from Baseline to Week 4.|
1658376|NCT01571362|3052056|Superiority or Other||Mean Difference (Net)|-0.74|Standard Error of the Mean|0.463||0.1139|2-Sided|95.0|-1.65|0.18||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|ANCOVA|||Model-adjusted change from Baseline to Week 2.|
1658377|NCT01571362|3052057|Superiority or Other||Mean Difference (Net)|0.07|Standard Error of the Mean|0.614||0.9063|2-Sided|95.0|-1.14|1.28||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 12.|
1658378|NCT01571362|3052057|Superiority or Other||Mean Difference (Net)|0.58|Standard Error of the Mean|0.684||0.3951|2-Sided|95.0|-0.77|1.93||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 8.|
1658379|NCT01571362|3052057|Superiority or Other||Mean Difference (Net)|-0.7|Standard Error of the Mean|0.642||0.2783|2-Sided|95.0|-1.96|0.57||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 4.|
1658380|NCT01571362|3052057|Superiority or Other||Mean Difference (Net)|-1.05|Standard Error of the Mean|0.584||0.0733|2-Sided|95.0|-2.2|0.1||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|ANCOVA|||Model-adjusted Change from Screening to Week 2.|
1658381|NCT01571362|3052058|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline.|
1658382|NCT01571362|3052059|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to the End of Open-Label Titration Period.|
1658383|NCT01571362|3052069|Superiority or Other|||||||0.006|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors.|||
1658384|NCT01571362|3052071|Superiority or Other|||||||0.0021|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 50% loss of analgesic response|
1658385|NCT01571362|3052071|Superiority or Other|||||||0.0006|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 40% loss of analgesic response.|
1658386|NCT01571362|3052071|Superiority or Other|||||||0.0024|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 30% loss of analgesic response.|
1658387|NCT01571362|3052071|Superiority or Other|||||||0.0014|||||||Wilcoxon test, survival analysis|P-value from Wilcoxon test with treatment and opioid stratum as factors||Time to 20% loss of analgesic response|
1658503|NCT01569451|3052264|Superiority or Other|||||||0.4904|||||||t-test, 2 sided|||T-test|
1658388|NCT01571362|3052077|Superiority or Other||Difference of LS Means|-3.87|Standard Error of the Mean|50.5||0.939|2-Sided|95.0|-103.29|95.55|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the average daily rescue acetaminophen during the Titration Period and final total daily study medication dose of the Titration Period as covariates.||
1658389|NCT01571362|3052078|Superiority or Other||Difference of LS Means|-27.75|Standard Error of the Mean|10.968||0.012|2-Sided|95.0|-49.34|-6.16|||ANCOVA||Difference between treatment groups evaluated by ANCOVA with treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.||
1658390|NCT01571362|3052079|Superiority or Other||Difference of LS Means|-0.64|Standard Error of the Mean|0.245||0.0096|2-Sided|95.0|-1.12|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/ Early Termination.|
1658391|NCT01571362|3052079|Superiority or Other||Difference of LS Means|-0.15|Standard Error of the Mean|0.262||0.5704|2-Sided|95.0|-0.67|0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.|
1658392|NCT01571362|3052079|Superiority or Other||Difference of LS Means|-0.47|Standard Error of the Mean|0.238||0.0501|2-Sided|95.0|-0.94|0.0|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.|
1658393|NCT01571362|3052079|Superiority or Other||Difference of LS Means|-0.41|Standard Error of the Mean|0.228||0.0727|2-Sided|95.0|-0.86|0.04|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.|
1658394|NCT01571362|3052080|Superiority or Other||Difference of LS Means|-1.04|Standard Error of the Mean|0.243|<|0.0001|2-Sided|95.0|-1.52|-0.56|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.|
1658395|NCT01571362|3052080|Superiority or Other||Difference of LS Means|-0.73|Standard Error of the Mean|0.272|<|0.0078|2-Sided|95.0|-1.27|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.|
1658396|NCT01571362|3052080|Superiority or Other||Difference of LS Means|-0.77|Standard Error of the Mean|0.235|<|0.0012|2-Sided|95.0|-1.23|-0.31|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.|
1658397|NCT01571362|3052080|Superiority or Other||Difference of LS Means|-0.66|Standard Error of the Mean|0.218|<|0.0025|2-Sided|95.0|-1.09|-0.24|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.|
1658398|NCT01571362|3052081|Superiority or Other||Difference of LS Means|-1.02|Standard Error of the Mean|0.264||0.0001|2-Sided|95.0|-1.54|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/ Early Termination.|
1658399|NCT01571362|3052081|Superiority or Other||Difference of LS Means|-0.71|Standard Error of the Mean|0.307||0.0222|2-Sided|95.0|-1.31|-0.1|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.|
1658400|NCT01571362|3052081|Superiority or Other||Difference of LS Means|-0.66|Standard Error of the Mean|0.256||0.0099|2-Sided|95.0|-1.17|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.|
1658401|NCT01571362|3052081|Superiority or Other||Difference of LS Means|-0.6|Standard Error of the Mean|0.236||0.0115|2-Sided|95.0|-1.06|-0.14|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.|
1658402|NCT01571362|3052082|Superiority or Other||Difference of LS Means|-1.04|Standard Error of the Mean|0.245|<|0.0001|2-Sided|95.0|-1.52|-0.56|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.|
1658403|NCT01571362|3052082|Superiority or Other||Difference of LS Means|-0.79|Standard Error of the Mean|0.271|<|0.0041|2-Sided|95.0|-1.32|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.|
1658404|NCT01571362|3052082|Superiority or Other||Difference of LS Means|-0.78|Standard Error of the Mean|0.235|<|0.001|2-Sided|95.0|-1.25|-0.32|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.|
1658405|NCT01571362|3052082|Superiority or Other||Difference of LS Means|-0.8|Standard Error of the Mean|0.214|<|0.0002|2-Sided|95.0|-1.22|-0.38|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.|
1658406|NCT01571362|3052083|Superiority or Other||Difference of LS Means|-0.98|Standard Error of the Mean|0.243|<|0.0001|2-Sided|95.0|-1.46|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.|
1658407|NCT01571362|3052083|Superiority or Other||Difference of LS Means|-0.77|Standard Error of the Mean|0.263|<|0.0038|2-Sided|95.0|-1.29|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.|
1658408|NCT01571362|3052083|Superiority or Other||Difference of LS Means|-0.89|Standard Error of the Mean|0.234|<|0.0002|2-Sided|95.0|-1.36|-0.43|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.|
1658409|NCT01571362|3052083|Superiority or Other||Difference of LS Means|-0.51|Standard Error of the Mean|0.224|<|0.025|2-Sided|95.0|-0.95|-0.06|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.|
1658410|NCT01571362|3052084|Superiority or Other||Difference of LS Means|-1.1|Standard Error of the Mean|0.289||0.0002|2-Sided|95.0|-1.67|-0.53|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 12/Early Termination.|
1658411|NCT01571362|3052084|Superiority or Other||Difference of LS Means|-0.56|Standard Error of the Mean|0.315||0.0769|2-Sided|95.0|-1.18|0.06|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 8.|
1658412|NCT01571362|3052084|Superiority or Other||Difference of LS Means|-0.73|Standard Error of the Mean|0.277||0.0087|2-Sided|95.0|-1.28|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 4.|
1658413|NCT01571362|3052084|Superiority or Other||Difference of LS Means|-0.71|Standard Error of the Mean|0.258||0.0061|2-Sided|95.0|-1.22|-0.2|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Screening score as covariate.|Difference between treatment groups in change from Screening to Week 2.|
1658414|NCT01571362|3052085|Superiority or Other||Difference of LS Means|-0.65|Standard Error of the Mean|0.207||0.0018|2-Sided|95.0|-1.06|-0.25|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.|
1658415|NCT01571362|3052085|Superiority or Other||Difference of LS Means|-0.17|Standard Error of the Mean|0.222||0.4529|2-Sided|95.0|-0.6|0.27|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.|
1658416|NCT01571362|3052085|Superiority or Other||Difference of LS Means|-0.48|Standard Error of the Mean|0.188||0.0106|2-Sided|95.0|-0.85|-0.11|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.|
1658417|NCT01571362|3052085|Superiority or Other||Difference of LS Means|-0.41|Standard Error of the Mean|0.188||0.0285|2-Sided|95.0|-0.78|-0.04|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.|
1658418|NCT01571362|3052086|Superiority or Other||Difference of LS Means|-0.95|Standard Error of the Mean|0.207|<|0.0001|2-Sided|95.0|-1.35|-0.54|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.|
1658419|NCT01571362|3052086|Superiority or Other||Difference of LS Means|-0.61|Standard Error of the Mean|0.228|<|0.0078|2-Sided|95.0|-1.06|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.|
1658420|NCT01571362|3052086|Superiority or Other||Difference of LS Means|-0.76|Standard Error of the Mean|0.198|<|0.0002|2-Sided|95.0|-1.15|-0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.|
1658421|NCT01571362|3052086|Superiority or Other||Difference of LS Means|-0.58|Standard Error of the Mean|0.189|<|0.0022|2-Sided|95.0|-0.95|-0.21|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.|
1658422|NCT01571362|3052087|Superiority or Other||Difference of LS Means|-1.07|Standard Error of the Mean|0.231|<|0.0001|2-Sided|95.0|-1.52|-0.62|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.|
1658423|NCT01571362|3052087|Superiority or Other||Difference of LS Means|-0.71|Standard Error of the Mean|0.264|<|0.0078|2-Sided|95.0|-1.23|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.|
1658424|NCT01571362|3052087|Superiority or Other||Difference of LS Means|-0.79|Standard Error of the Mean|0.214|<|0.0003|2-Sided|95.0|-1.21|-0.37|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.|
1658425|NCT01571362|3052087|Superiority or Other||Difference of LS Means|-0.64|Standard Error of the Mean|0.207|<|0.0022|2-Sided|95.0|-1.05|-0.23|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.|
1658426|NCT01571362|3052088|Superiority or Other||Difference of LS Means|-0.88|Standard Error of the Mean|0.221|<|0.0001|2-Sided|95.0|-1.31|-0.44|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.|
1658504|NCT01569451|3052265|Superiority or Other|||||||1|||||||Fisher Exact||||
1658505|NCT01569451|3052266|Superiority or Other|||||||0.3507|||||||Fisher Exact||||
1658427|NCT01571362|3052088|Superiority or Other||Difference of LS Means|-0.64|Standard Error of the Mean|0.236|<|0.007|2-Sided|95.0|-1.11|-0.18|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.|
1658428|NCT01571362|3052088|Superiority or Other||Difference of LS Means|-0.74|Standard Error of the Mean|0.213|<|0.0006|2-Sided|95.0|-1.16|-0.32|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.|
1658429|NCT01571362|3052088|Superiority or Other||Difference of LS Means|-0.65|Standard Error of the Mean|0.19|<|0.0007|2-Sided|95.0|-1.02|-0.27|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.|
1658430|NCT01571362|3052089|Superiority or Other||Difference of LS Means|-0.86|Standard Error of the Mean|0.21|<|0.0001|2-Sided|95.0|-1.27|-0.44|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.|
1658431|NCT01571362|3052089|Superiority or Other||Difference of LS Means|-0.64|Standard Error of the Mean|0.226|<|0.0055|2-Sided|95.0|-1.08|-0.19|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.|
1658432|NCT01571362|3052089|Superiority or Other||Difference of LS Means|-0.87|Standard Error of the Mean|0.201|<|0.0001|2-Sided|95.0|-1.27|-0.48|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4|
1658433|NCT01571362|3052089|Superiority or Other||Difference of LS Means|-0.4|Standard Error of the Mean|0.193|<|0.0412|2-Sided|95.0|-0.78|-0.02|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2|
1658434|NCT01571362|3052090|Superiority or Other||Difference of LS Means|-0.98|Standard Error of the Mean|0.244|<|0.0001|2-Sided|95.0|-1.46|-0.5|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 12/Early Termination.|
1658435|NCT01571362|3052090|Superiority or Other||Difference of LS Means|-0.37|Standard Error of the Mean|0.271|<|0.1684|2-Sided|95.0|-0.91|0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 8.|
1658436|NCT01571362|3052090|Superiority or Other||Difference of LS Means|-0.64|Standard Error of the Mean|0.243|<|0.009|2-Sided|95.0|-1.12|-0.16|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 4.|
1658437|NCT01571362|3052090|Superiority or Other||Difference of LS Means|-0.62|Standard Error of the Mean|0.222|<|0.0056|2-Sided|95.0|-1.06|-0.18|||ANCOVA||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and the Randomization Baseline score and final total daily dose of the Titration Period as covariates.|Difference between treatment groups in change from Randomization Baseline to Week 2.|
1658438|NCT01571362|3052091|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Interference Index|
1658439|NCT01571362|3052091|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Severity Index|
1658440|NCT01571362|3052091|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Pain Right Now|
1658441|NCT01571362|3052091|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Average Pain Score|
1658442|NCT01571362|3052091|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Least Pain Score|
1658443|NCT01571362|3052091|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to Randomization Baseline for Worst Pain Score|
1658444|NCT01571362|3052092|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Interference Index|
1658445|NCT01571362|3052092|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Severity Index|
1658446|NCT01571362|3052092|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Pain Right Now|
1658447|NCT01571362|3052092|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Average Pain Score|
1658448|NCT01571362|3052092|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Least Pain Score|
1658449|NCT01571362|3052092|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Screening Period value to end of the OL Period for Worst Pain Score|
1658450|NCT01571362|3052093|Superiority or Other|||||||0.0874|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).|||
1658451|NCT01571362|3052094|Superiority or Other|||||||0.009|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).|||
1658452|NCT01571362|3052095|Superiority or Other|||||||0.0248|||||||Cochran-Mantel-Haenszel|The CMH test was stratified by prior pain analgesic (opioid or non-opioid).|||
1658506|NCT01569451|3052267|Superiority or Other|||||||0.094|||||||Chi-squared||||
1658455|NCT01571362|3052098|Superiority or Other||Difference of LS Means|0.18|Standard Error of the Mean|0.565||0.7547|2-Sided|95.0|-0.94|1.29||Treatment and prior pain analgesic (opioid or non-opioid) as categorical factors and Baseline score and final total daily dose of Titration Period as covariates.|ANCOVA||||
1658456|NCT01571362|3052099|Superiority or Other||Difference of LS Means|-0.62|Standard Error of the Mean|0.246||0.0114|2-Sided|95.0|-1.11|-0.14||No adjustment was made for multiple comparisons. Statistical significance was if unadjusted p was less than or equal to (<=) 0.05.|ANCOVA|||Null Hypothesis: No treatment difference. Power was 90%, 2-sided Alpha of 0.05, with assumed difference of 1 point and assumed standard deviation of 2.4 points.|
1658457|NCT01570491|3052148|Superiority|||||||0.06|||||||Kruskal-Wallis||||
1658458|NCT01570491|3052149|Superiority|||||||0.09|||||||Kruskal-Wallis||||
1658459|NCT01570491|3052150|Superiority|||||||0.001|||||||Kruskal-Wallis||||
1658460|NCT01570491|3052151|Superiority or Other|||||||0.83|||||||Kruskal-Wallis|||"We hypothesized that real-time US guidance would result in a 20% lower number of attempts compared to the control group.~At the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group, therefore we planned to recruit 40 patients in total."|
1658461|NCT01570361|3052164|Superiority|||||||0.0041||||||The alpha level is 0.025 for this secondary endpoint.|Log Rank|One-sided test|||
1658462|NCT01570361|3052165|Superiority|||||||0.0118||||||The alpha level is 0.025 for this secondary endpoint.|Log Rank|One-sided test|||
1658463|NCT01570361|3052166|Superiority|||||||0.0009||||||Prior to the final analysis, study had two interim analyses. Hence alpha level is 0.0231 for primary analysis adjusted for the two interim analyses.|Log Rank|One-sided test|||
1658464|NCT01570244|3052187|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|153.85|Standard Deviation|8.2|||2-Sided|90.0|145.99|162.14|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel|
1658465|NCT01570244|3052188|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|115.28|Standard Deviation|6.1|||2-Sided|90.0|110.81|119.92|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel|
1658466|NCT01570244|3052189|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric mean ratio|140.53|Standard Deviation|4.6|||2-Sided|90.0|136.4|144.78|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Levonorgestrel|
1658467|NCT01570244|3052192|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|171.37|Standard Deviation|10.5|||2-Sided|90.0|160.2|183.33|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol|
1658468|NCT01570244|3052193|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Odds Ratio (OR)|114.82|Standard Deviation|13.2|||2-Sided|90.0|105.49|124.97|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol|
1658469|NCT01570244|3052194|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|140.96|Standard Deviation|8.1|||2-Sided|90.0|133.84|148.47|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Microgynon + Faldaprevir : Microgynon) of Ethinylestradiol|
1658470|NCT01569568|3052240|Superiority or Other||||||<|0.001||||||Equal variances not assumed. Comparison of BRIEF GEC between cases and controls.|t-test, 2 sided||||
1658471|NCT01569568|3052240|Superiority or Other||||||<|0.001||||||Equal variances not assumed. Comparison of BRIEF MI cases and controls|t-test, 2 sided||||
1658472|NCT01569568|3052240|Superiority or Other||||||<|0.001||||||Equal variance not assumed. Comparison of BRIEF BRI cases and controls|t-test, 2 sided||||
1658473|NCT01569568|3052240|Superiority or Other||||||<|0.853||||||Equal variance not assumed. Comparison of CTMT global composite score between cases and controls|t-test, 2 sided||||
1658474|NCT01569568|3052240|Superiority or Other||||||<|0.094||||||Equal variance not assumed. Comparison of WASI full IQ cases and controls|t-test, 2 sided||||
1658475|NCT01569568|3052240|Superiority or Other||||||<|0.002||||||Equal variance not assumed. Comparison WASI performance IQ cases and controls|t-test, 2 sided||||
1658476|NCT01569568|3052240|Superiority or Other||||||<|0.929||||||Equal variance is not assumed. Two tailed t-test WASI verbal IQ between cases and controls|t-test, 2 sided||||
1658477|NCT01569568|3052242|Superiority or Other|||||||0.023||||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the right aI/fO node and the right SFG node does not differ between groups.|
1658478|NCT01569568|3052242|Superiority or Other|||||||0.003||||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the right aI/fO node and the left SFG node does not differ between groups.|
1658479|NCT01569568|3052242|Superiority or Other|||||||0.853||||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO and the right SFG node does not differ between groups.|
1658480|NCT01569568|3052242|Superiority or Other|||||||0.256||||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO node and the right aI/fO node does not differ between groups.|
1658507|NCT01569451|3052268|Superiority or Other|||||||0.3167|||||||Chi-squared||||
1658508|NCT01569451|3052269|Superiority or Other|||||||0.0189|||||||Chi-squared||||
1658509|NCT01569451|3052270|Superiority or Other|||||||0.0268|||||||Peto||||
1658481|NCT01569568|3052242|Superiority or Other|||||||0.426||||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left aI/fO and the left SFG node does not differ between groups.|
1658482|NCT01569568|3052242|Superiority or Other|||||||0.005||||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the right SFG node does not differ between groups.|
1658483|NCT01569568|3052242|Superiority or Other|||||||0.039||||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the right aI/fO node does not differ between groups.|
1658484|NCT01569568|3052242|Superiority or Other|||||||0.113||||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the left SFG node does not differ between groups.|
1658485|NCT01569568|3052242|Superiority or Other|||||||0.55||||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC node and the left aI/fO node does not differ between groups.|
1658486|NCT01569568|3052242|Superiority or Other||||||<|0.001||||||Our a priori threshold for statistical significance was 0.05.|ANOVA|We ran a 2 (Group) x 6 (ROI Pair) ANOVA to assess functional connectivity between the nodes of the SMN, using age as a covariate.||The null hypothesis states predicts no main effects of Group, ROI pair, or Age, suggesting that the connectivity between all SMN nodes is the same across groups.|
1658487|NCT01569568|3052242|Superiority or Other||||||<|0.801||||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the PCC node and the right IPL node does not differ between groups.|
1658488|NCT01569568|3052242|Superiority or Other||||||<|0.829||||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the PCC node and the left IPL node does not differ between groups.|
1658489|NCT01569568|3052242|Superiority or Other||||||<|0.47||||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the left IPL node and the right IPL node does not differ between groups.|
1658490|NCT01569568|3052242|Superiority or Other||||||<|0.008||||||This is an uncorrected p-value. A priori significance threshold was 0.05|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the right IPL node does not differ between groups.|
1658491|NCT01569568|3052242|Superiority or Other||||||<|0.04||||||This is an uncorrected p-value. A priori significance threshold is 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the PCC node does not differ between groups.|
1658492|NCT01569568|3052242|Superiority or Other||||||<|0.024||||||This is an uncorrected p-value. A priori significance threshold was 0.05.|ANOVA|We ran a series of post-hoc one-way ANOVAs to localize the main effect found. Age was used as a covariate.||The null hypothesis predicts that functional connectivity between the ACC/mPFC node and the left IPL node does not differ between groups.|
1658493|NCT01569568|3052242|Superiority or Other||||||<|0.001||||||Our a priori threshold for statistical significance was 0.05.|ANOVA|We ran a 2 (Group) x 6 (ROI Pair) ANOVA to assess functional connectivity between the nodes of the DMN, using age as a covariate.||The null hypothesis states predicts no main effects of Group, ROI pair, or Age, suggesting that the connectivity between all DMN nodes is the same across groups.|
1658494|NCT01569568|3052243|Superiority or Other|||||||0.046||||||This is an uncorrected p-value. A priori threshold was 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of myoinositol is the same for controls and OTCD patients in PWM.|
1658495|NCT01569568|3052243|Superiority or Other|||||||0.004||||||This is an uncorrected p-value. A priori threshold was 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of glutamine is the same for controls and OTCD patients in PWM.|
1658496|NCT01569568|3052243|Superiority or Other|||||||0.011||||||This is an uncorrected p-value. A priori significance threshold is 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of myoinositol is the same for controls and OTCD patients in PCGM.|
1658497|NCT01569568|3052243|Superiority or Other|||||||0.001||||||This is an uncorrected p-value. A priori threshold is 0.05.|t-test, 2 sided|||The null hypothesis predicts that the concentration of glutamine is the same for controls and OTCD patients in PCGM.|
1658498|NCT01569464|3052259|Superiority or Other||LS Mean|0.07|Standard Error of the Mean|0.34||0.8336|2-Sided|95.0|-0.61|0.75||A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.|ANCOVA|||ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.|
1658499|NCT01569464|3052260|Superiority or Other||LS Mean|-0.27|Standard Error of the Mean|1.36||0.8451|2-Sided|95.0|-2.96|2.42||A hierarchical test procedure was done for the primary efficacy variables at an α-level of 5 %. If a test was statistically significant, a test for the next variable was performed. If a test was not statistically significant the procedure stopped.|ANCOVA|||ANCOVA model was used for analysis with fixed effects for treatment assignment (main factor) and the subject's investigational center (stratifying factor) and a covariate for the Baseline Visit value of the IRLS sum score.|
1658511|NCT01569295|3052276|Superiority||Odds Ratio (OR)|9.55||||0.011|2-Sided|95.0|1.19|76.81||Odds ratio, 95% CI and p-value are calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).|Cochran-Mantel-Haenszel||||
1658512|NCT01569295|3052277|Superiority||Hazard Ratio (HR)|0.78||||0.098|2-Sided|95.0|0.59|1.03|||Stratified log-rank test||||
1658513|NCT01569295|3052278|Superiority||Odds Ratio (OR)|28.81|||<|0.0001|2-Sided|95.0|10.5|79.02||Odds ratio, p-value and 95% CI were calculated from the CMH Chi-square test stratified by stratification factors in EDC (del17p/TP53, IgHV mutation and disease status).|Cochran-Mantel-Haenszel||||
1658514|NCT01569295|3052279|Superiority||Odds Ratio (OR)|3.02|||<|0.0001|2-Sided|95.0|1.98|4.62||Odds ratio,p-value and 95% Confidence Interval(CI) were calculated from Cochran-Mantel-Haenszel(CMH) Chi-square test stratified by stratification factor in EDC(del17p/TP53,immunoglobulin heavy chain variable region(IgHV) mutation and disease status).|Cochran-Mantel-Haenszel||||
1658515|NCT01569295|3052280|Superiority||Hazard Ratio (HR)|0.35|||<|0.0001|2-Sided|95.0|0.27|0.45|||Stratified log-rank test||Hazard Ratio is estimated using Cox proportional hazard model, adjusted for randomization stratification factors.||
1658516|NCT01569152|3052285|Superiority or Other||Difference in percentages|31.71|||<|0.001|2-Sided|95.0|15.56|47.86|||Cochran-Mantel-Haenszel||||
1658517|NCT01569152|3052287|Superiority or Other||Difference in least squares means|-4.9||||0.315|2-Sided|95.0|-14.54|4.74|||Constrained Longitudinal Data Analysis||||
1658518|NCT01569152|3052288|Superiority or Other||Difference in least squares means|-1.59||||0.007|2-Sided|95.0|-2.73|-0.45|||Constrained Longitudinal Data Analysis||||
1658519|NCT01569152|3052289|Superiority or Other||Difference in least squares means|-0.62|||<|0.001|2-Sided|95.0|-0.84|-0.4|||Constrained Longitudinal Data Analysis||||
1658520|NCT01569152|3052290|Superiority or Other||Difference in least squares means|-20.69|||<|0.001|2-Sided|95.0|-31.29|-10.09|||Constrained Longitudinal Data Analysis||||
1658521|NCT01569152|3052291|Superiority or Other||Difference in least squares means|-19.48|||<|0.001|2-Sided|95.0|-29.69|-9.28|||Constrained Longitudinal Data Analysis||||
1658522|NCT01569152|3052292|Superiority or Other||Difference in least squares means|-20.84|||<|0.001|2-Sided|95.0|-29.98|-11.71|||Constrained Longitudinal Data Analysis||||
1658523|NCT01569152|3052295|Superiority or Other||Difference in least squares means|-10.56||||0.002|2-Sided|95.0|-16.97|-4.15|||Constrained Longitudinal Data Analysis||||
1658524|NCT01569152|3052296|Superiority or Other||Difference in least squares means|-2.65||||0.11|2-Sided|95.0|-5.91|0.62|||Constrained Longitudinal Data Analysis||||
1658525|NCT01569152|3052297|Superiority or Other||Difference in least squares means|-4.75||||0.028|2-Sided|95.0|-8.99|-0.52|||Constrained Longitudinal Data Analysis||||
1658526|NCT01569152|3052300|Superiority or Other||Difference in percentages|12.2||||0.018|2-Sided|95.0|2.18|22.21|||Cochran-Mantel-Haenszel||||
1658527|NCT01569152|3052301|Superiority or Other||Difference in percentages|9.76||||0.039|2-Sided|95.0|0.67|18.84|||Cochran-Mantel-Haenszel||||
1658528|NCT01569152|3052302|Superiority or Other||Difference in percentages|29.27||||0.007|2-Sided|95.0|8.9|49.63|||Cochran-Mantel-Haenszel||||
1658529|NCT01569152|3052303|Superiority or Other||Difference in percentages|31.71||||0.004|2-Sided|95.0|11.29|52.13|||Cochran-Mantel-Haenszel||||
1658530|NCT01569152|3052306|Superiority or Other||Difference in percentages|14.63||||0.044|2-Sided|95.0|0.83|28.44|||Cochran-Mantel-Haenszel||||
1658531|NCT01569152|3052307|Superiority or Other||Difference in least squares means|-1.11|||<|0.001|2-Sided|95.0|-1.62|-0.6|||Constrained Longitudinal Data Analysis||||
1658532|NCT01569152|3052308|Superiority or Other||Difference in least squares means|-0.98|||<|0.001|2-Sided|95.0|-1.53|-0.43|||Constrained Longitudinal Data Analysis||||
1658533|NCT01569152|3052309|Superiority or Other||Difference of percentages|43.9|||<|0.001|2-Sided|95.0|24.52|63.28|||Cochran-Mantel-Haenszel||||
1658534|NCT01569126|3052310|Superiority or Other||Slope|0.026||||||95.0|||||||The correlation of time-matched change from baseline QTcF interval (dependent variable) to the time-matched plasma concentration of total fluoxetine and norfluoxetine (covariate) and participant (random effect).||
1658535|NCT01569087|3052324|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1658536|NCT01569074|3052325|Superiority or Other||Treatment difference|1.45||||0.481|2-Sided|80.0|-1.19|4.09|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658537|NCT01569074|3052325|Superiority or Other||Treatment difference|-1.63||||0.432|2-Sided|80.0|-4.3|1.04|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658538|NCT01569074|3052325|Superiority or Other||Treatment difference|2.47||||0.223|2-Sided|80.0|-0.13|5.07|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658539|NCT01569074|3052325|Superiority or Other||Treatment difference|3.12||||0.139|2-Sided|80.0|0.42|5.82|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658607|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|-25.08|Standard Error of the Mean|16.243|||2-Sided|95.0|-59.2|9.05|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion|
1658540|NCT01569074|3052326|Superiority or Other||Treatment difference|1.03||||0.548|2-Sided|80.0|-1.17|3.23|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658541|NCT01569074|3052326|Superiority or Other||Treatment difference|-0.42||||0.806|2-Sided|80.0|-2.64|1.8|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658542|NCT01569074|3052326|Superiority or Other||Treatment difference|0.25||||0.881|2-Sided|80.0|-1.91|2.41|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658543|NCT01569074|3052326|Superiority or Other||Treatment difference|3.01||||0.087|2-Sided|80.0|0.76|5.26|||ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658544|NCT01569074|3052327|Superiority or Other||Odds Ratio (OR)|0.8||||0.748|2-Sided|80.0|0.42|1.69||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658545|NCT01569074|3052327|Superiority or Other||Odds Ratio (OR)|0.8||||0.614|2-Sided|80.0|0.37|1.54||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658546|NCT01569074|3052327|Superiority or Other||Odds Ratio (OR)|0.9||||0.833|2-Sided|80.0|0.45|1.78||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658547|NCT01569074|3052327|Superiority or Other||Odds Ratio (OR)|2.2||||0.169|2-Sided|80.0|1.06|4.67||Week 12|Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ration >1 indicates a benefit towards fostamatinib|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658548|NCT01569074|3052328|Superiority or Other||Odds Ratio (OR)|1.81||||0.239|2-Sided|80.0|0.95|3.44|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658549|NCT01569074|3052328|Superiority or Other||Odds Ratio (OR)|0.87||||0.781|2-Sided|80.0|0.45|1.67|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658550|NCT01569074|3052328|Superiority or Other||Odds Ratio (OR)|1.49||||0.423|2-Sided|80.0|0.79|2.82|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658551|NCT01569074|3052328|Superiority or Other||Odds Ratio (OR)|2.17||||0.131|2-Sided|80.0|1.12|4.2|||Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658608|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|-4.88|Standard Error of the Mean|4.155|||2-Sided|95.0|-22.75|13.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting|
1660255|NCT01554241|3054005|Superiority or Other||||||=|0|||||||ANOVA|Bonferroni/Dunn adjustment|||
1658552|NCT01569074|3052329|Superiority or Other||Odds Ratio (OR)|1.8||||0.481|2-Sided|80.0|0.63|5.04|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658553|NCT01569074|3052329|Superiority or Other||Odds Ratio (OR)|2.5||||0.257|2-Sided|80.0|0.89|6.89|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658554|NCT01569074|3052329|Superiority or Other||Odds Ratio (OR)|5.1||||0.033|2-Sided|80.0|1.92|13.61|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658555|NCT01569074|3052329|Superiority or Other||Odds Ratio (OR)|5.3||||0.033|2-Sided|80.0|1.94|14.31|||Regression, Logistic|Odds ratio and 80% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658556|NCT01569074|3052330|Superiority or Other|||||||0.263||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658557|NCT01569074|3052330|Superiority or Other|||||||0.317||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658558|NCT01569074|3052330|Superiority or Other|||||||0.065||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658559|NCT01569074|3052330|Superiority or Other|||||||0.073||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-value estimated using the Van Elteren method stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658560|NCT01569074|3052331|Superiority or Other||Weighted difference in proportions|0.14||||0.021|2-Sided|80.0|0.06|0.22||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658561|NCT01569074|3052331|Superiority or Other||Weighted difference in proportions|0.12||||0.028|2-Sided|80.0|0.05|0.19||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658562|NCT01569074|3052332|Superiority or Other||Weighted difference in proportions|-0.04||||0.645|2-Sided|80.0|-0.13|0.06||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658563|NCT01569074|3052332|Superiority or Other||Weighted difference in proportions|-0.07||||0.334|2-Sided|80.0|-0.17|0.02||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658609|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|-3.1|Standard Error of the Mean|4.811|||2-Sided|95.0|-23.8|17.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting|
1658610|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|-7.91|Standard Error of the Mean|7.832|||2-Sided|95.0|-23.93|8.11|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain|
1658564|NCT01569074|3052332|Superiority or Other||Weighted difference in proportions|0.21||||0.035|2-Sided|80.0|0.08|0.34||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658565|NCT01569074|3052332|Superiority or Other||Weighted difference in proportions|0.17||||0.114|2-Sided|80.0|0.03|0.31||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658566|NCT01569074|3052333|Superiority or Other||Weighted difference in proportions|0.03||||0.704|2-Sided|80.0|-0.08|0.15||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658567|NCT01569074|3052333|Superiority or Other||Weighted difference in proportions|0.06||||0.489|2-Sided|80.0|-0.05|0.18||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658568|NCT01569074|3052333|Superiority or Other||Weighted difference in proportions|0.11||||0.172|2-Sided|80.0|0.01|0.21||Week 1|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658569|NCT01569074|3052334|Superiority or Other||Weighted difference in proportions|0.14||||0.262|2-Sided|80.0|-0.02|0.29||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658570|NCT01569074|3052334|Superiority or Other||Weighted difference in proportions|-0.06||||0.57|2-Sided|80.0|-0.2|0.08||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658571|NCT01569074|3052334|Superiority or Other||Weighted difference in proportions|0.24||||0.054|2-Sided|80.0|0.08|0.39||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied|
1658572|NCT01569074|3052334|Superiority or Other||Weighted difference in proportions|0.23||||0.059|2-Sided|80.0|0.07|0.39||Week 12|Mantel Haenszel|Treatment difference in proportion of responders, with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or following receipt of any parenteral steroids, or for patients with no post baseline data. Subjects who prematurely withdrew due to project closure have no imputation applied.|
1658573|NCT01569022|3052335|Equivalence|t test assuming unequal variance|||||<|0.001|||||||t-test, 2 sided||||
1658574|NCT01569022|3052336|Equivalence|t test assuming unequal variance||||||0.54|||||||t-test, 2 sided||||
1658575|NCT01569022|3052337|Equivalence|t-test assuming non unequal variance||||||0.31|||||||t-test, 2 sided|||PSQI|
1658576|NCT01569022|3052337|Equivalence|t test assuming unequal variance||||||0.98|||||||t-test, 2 sided|||PCL|
1658577|NCT01569022|3052337|Equivalence|t test assuming unequal variance||||||0.97|||||||t-test, 2 sided|||ESS|
1658578|NCT01569022|3052338|Equivalence|The primary endpoint of the study was tested by comparing difference in residual AHI using the paired t test|||||<|0.001|||||||t-test, 2 sided||||
1658579|NCT01568892|3052381|Superiority or Other||Mean Difference (Net)|-1.16|||<|0.001|2-Sided|95.0|-1.52|-0.8|||ANCOVA||The estimated value represents the adjusted mean difference between the two treatment arms.||
1658580|NCT01568866|3052385|Superiority or Other||Odds Ratio (OR)|0.137|||<|0.0001|2-Sided|95.0|0.089|0.21||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Cochran-Mantel-Haenszel||The odds ratio (carfilzomib/bortezomib) was estimated using the unconditional Cochran-Mantel-Haenszel method.||
1658581|NCT01568866|3052387|Superiority or Other||Odds Ratio (OR)|2.032|||<|0.0001|2-Sided|95.0|1.519|2.718||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Stratified Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by the randomization stratification factors.|The odds ratio (carfilzomib/bortezomib) was calculated using the Cochran-Mantel-Haenszel method stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.||
1658611|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|-1.69|Standard Error of the Mean|8.488|||2-Sided|95.0|-19.03|15.64|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain|
1658582|NCT01568866|3052388|Superiority or Other||Hazard Ratio (HR)|0.791||||0.01|2-Sided|95.0|0.648|0.964||The multiplicity in testing secondary endpoints was adjusted per group using the sequential Holm procedure to preserve the family-wise error rate at 0.025.|Stratified Log Rank|Log rank test stratified by the randomization stratification factors.|The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|The second interim analysis of overall survival was to be conducted after 394 events had been reached. A one-sided significance level was determined using the O’Brien-Fleming–type α spending function based on the actual number of events (α=0.0123).|
1658583|NCT01568866|3052389|Superiority or Other||Hazard Ratio (HR)|0.533|||<|0.0001|2-Sided|95.0|0.437|0.651|||Stratified Log Rank|Log rank test stratified by the randomization stratification factors.|The hazard ratio (carfilzomib/bortezomib) was estimated using a Cox proportional hazards model stratified by prior proteasome inhibitor treatment, lines of prior treatment, ISS stage, and choice of route of bortezomib administration.|"The PFS interim analysis was to be performed using a group sequential monitoring plan.~The monitoring plan included an O’Brien-Fleming type of efficacy stopping boundary constructed using the Lan-DeMets alpha spending function to ensure a 1-sided Type I error rate ≤ 0.025."|
1658584|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|11.27|Standard Error of the Mean|7.928|||2-Sided|95.0|-5.22|27.76|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence|
1658585|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|98.65|Standard Error of the Mean|74.566|||2-Sided|95.0|-58.01|255.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence|
1658586|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|67.12|Standard Error of the Mean|41.961|||2-Sided|95.0|-22.88|157.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating|
1658587|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|-14.36|Standard Error of the Mean|9.811|||2-Sided|95.0|-35.56|6.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating|
1658588|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|2.76|Standard Error of the Mean|11.219|||2-Sided|95.0|-28.38|33.91|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation|
1658589|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|5.83|Standard Error of the Mean|19.649|||2-Sided|95.0|-48.73|60.38|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation|
1658590|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|-0.94|Standard Error of the Mean|1.242|||2-Sided|95.0|-3.71|1.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion|
1658591|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|2.46|Standard Error of the Mean|2.801|||2-Sided|95.0|-3.65|8.56|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion|
1658592|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|18.56|Standard Error of the Mean|27.886|||2-Sided|95.0|-42.19|79.32|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain|
1658593|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|-1.14|Standard Error of the Mean|1.705|||2-Sided|95.0|-5.08|2.79|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain|
1658594|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|0.61|Standard Error of the Mean|0.775|||2-Sided|95.0|-1.17|2.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain|
1658595|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|0.74|Standard Error of the Mean|0.794|||2-Sided|95.0|-1.1|2.57|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain|
1658596|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|-4.48|Standard Error of the Mean|4.597|||2-Sided|95.0|-14.11|5.14||||||Diarrhea|
1658597|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|0.43|Standard Error of the Mean|5.717|||2-Sided|95.0|-11.64|12.49|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea|
1658598|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|-2.0|Standard Error of the Mean|2.18|||2-Sided|95.0|-6.62|2.62|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea|
1658599|NCT01568112|3052405|Superiority or Other||Mean Difference (Final Values)|-1.68|Standard Error of the Mean|2.626|||2-Sided|95.0|-7.35|3.99|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea|
1658600|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|51.78|Standard Error of the Mean|41.055|||2-Sided|95.0|-31.65|135.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence|
1658601|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|26.52|Standard Error of the Mean|32.896|||2-Sided|95.0|-40.13|93.18|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence|
1658602|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|81.89|Standard Error of the Mean|50.239|||2-Sided|95.0|-22.04|185.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating|
1658603|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|-2.73|Standard Error of the Mean|6.442|||2-Sided|95.0|-15.87|10.41|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating|
1658604|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|-6.33|Standard Error of the Mean|12.542|||2-Sided|95.0|-32.79|20.13|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation|
1658605|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|-12.49|Standard Error of the Mean|10.847|||2-Sided|95.0|-35.38|10.39|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation|
1658606|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|-23.95|Standard Error of the Mean|14.83|||2-Sided|95.0|-54.89|6.98|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion|
1658824|NCT01565980|3052748|Superiority or Other||||||<|0.05||||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis||||
1658612|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|-2.5|Standard Error of the Mean|4.671|||2-Sided|95.0|-12.08|7.09|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain|
1658613|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|10.84|Standard Error of the Mean|8.143|||2-Sided|95.0|-5.81|27.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain|
1658614|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|2.44|Standard Error of the Mean|2.379|||2-Sided|95.0|-2.41|7.29|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea|
1658615|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|13.51|Standard Error of the Mean|8.024|||2-Sided|95.0|-2.84|29.86|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea|
1658616|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|-4.37|Standard Error of the Mean|2.563|||2-Sided|95.0|-9.57|0.83|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea|
1658617|NCT01568112|3052406|Superiority or Other||Mean Difference (Final Values)|3.95|Standard Error of the Mean|5.281|||2-Sided|95.0|-6.79|14.68|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea|
1658618|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|54.78|Standard Error of the Mean|40.44|||2-Sided|95.0|-27.09|136.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence|
1658619|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|59.87|Standard Error of the Mean|65.007|||2-Sided|95.0|-71.51|191.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence|
1658620|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|60.33|Standard Error of the Mean|34.455|||2-Sided|95.0|-10.78|131.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating|
1658621|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|-7.24|Standard Error of the Mean|6.472|||2-Sided|95.0|-20.4|5.93|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating|
1658622|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|-7.29|Standard Error of the Mean|12.369|||2-Sided|95.0|-33.39|18.81|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation|
1658623|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|-13.93|Standard Error of the Mean|10.274|||2-Sided|95.0|-35.44|7.57|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation|
1658624|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|-11.58|Standard Error of the Mean|8.654|||2-Sided|95.0|-29.48|6.32|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion|
1658625|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|-12.69|Standard Error of the Mean|8.376|||2-Sided|95.0|-30.02|4.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion|
1658626|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|-9.33|Standard Error of the Mean|6.536|||2-Sided|95.0|-30.13|11.47|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting|
1658627|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|-8.21|Standard Error of the Mean|5.292|||2-Sided|95.0|-22.9|6.49|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting|
1658628|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|-6.18|Standard Error of the Mean|7.141|||2-Sided|95.0|-20.71|8.35|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain|
1658629|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|-3.09|Standard Error of the Mean|7.516|||2-Sided|95.0|-18.36|12.19|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain|
1658630|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|-2.84|Standard Error of the Mean|4.152|||2-Sided|95.0|-11.31|5.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain|
1658631|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|9.21|Standard Error of the Mean|7.812|||2-Sided|95.0|-6.72|25.14|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain|
1658632|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|2.05|Standard Error of the Mean|2.321|||2-Sided|95.0|-2.67|6.77|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea|
1658633|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|11.74|Standard Error of the Mean|7.335|||2-Sided|95.0|-3.15|26.63|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea|
1658634|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|-4.07|Standard Error of the Mean|2.347|||2-Sided|95.0|-8.81|0.67|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea|
1658635|NCT01568112|3052407|Superiority or Other||Mean Difference (Final Values)|2.96|Standard Error of the Mean|4.601|||2-Sided|95.0|-6.34|12.26|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea|
1658636|NCT01568112|3052408|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|8.8|||2-Sided|95.0|-17.2|18.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658637|NCT01568112|3052408|Superiority or Other||Mean Difference (Final Values)|17.5|Standard Error of the Mean|13.32|||2-Sided|95.0|-9.2|44.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658638|NCT01568112|3052409|Superiority or Other||Mean Difference (Final Values)|1.6|Standard Error of the Mean|11.08|||2-Sided|95.0|-20.5|23.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658639|NCT01568112|3052409|Superiority or Other||Mean Difference (Final Values)|22.2|Standard Error of the Mean|24.4|||2-Sided|95.0|-26.5|70.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658640|NCT01568112|3052410|Superiority or Other||Mean Difference (Final Values)|5.8|Standard Error of the Mean|10.03|||2-Sided|95.0|-14.2|25.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1660346|NCT01552928|3054176|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1658641|NCT01568112|3052410|Superiority or Other||Mean Difference (Final Values)|6.6|Standard Error of the Mean|13.79|||2-Sided|95.0|-20.9|34.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658642|NCT01568112|3052417|Superiority or Other||Difference in percentage|-2.0|||||2-Sided|95.0|-25.0|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658643|NCT01568112|3052417|Superiority or Other||Difference in percentage|-9.0|||||2-Sided|95.0|-32.1|14.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658644|NCT01568112|3052418|Superiority or Other||Difference in percentage|6.0|||||2-Sided|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658645|NCT01568112|3052418|Superiority or Other||Difference in percentage|2.0|||||2-Sided|95.0|-18.8|23.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658646|NCT01568112|3052419|Superiority or Other||Difference in percentage|9.0|||||2-Sided|95.0|-11.8|30.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658647|NCT01568112|3052419|Superiority or Other||Difference in percentage|9.0|||||2-Sided|95.0|-11.8|30.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658648|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.44|||2-Sided|95.0|-1.2|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence|
1658649|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.38|||2-Sided|95.0|-1.6|0.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence|
1658650|NCT01568112|3052420|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.38|||2-Sided|95.0|-0.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating|
1658651|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.37|||2-Sided|95.0|-0.8|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating|
1658652|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.2|||2-Sided|95.0|-0.2|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation|
1658653|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.28|||2-Sided|95.0|-0.1|1.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation|
1658654|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.29|||2-Sided|95.0|-0.7|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion|
1658655|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.32|||2-Sided|95.0|-0.6|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion|
1658656|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.4|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting|
1658657|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.19|||2-Sided|95.0|-0.4|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting|
1658658|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.38|||2-Sided|95.0|-0.2|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain|
1658659|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.33|||2-Sided|95.0|-0.6|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain|
1658660|NCT01568112|3052420|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|0.37|||2-Sided|95.0|-0.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain|
1658661|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.32|||2-Sided|95.0|-0.7|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain|
1658662|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.46|||2-Sided|95.0|-1.7|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea|
1658663|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.52|||2-Sided|95.0|-1.7|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea|
1658664|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.41|||2-Sided|95.0|-0.8|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea|
1658665|NCT01568112|3052420|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.44|||2-Sided|95.0|-1.0|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea|
1658666|NCT01568112|3052421|Superiority or Other||Mean Difference (Net)|0.2|Standard Error of the Mean|0.46|||2-Sided|95.0|-0.7|1.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence|
1658667|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.41|||2-Sided|95.0|-0.8|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Flatulence|
1658668|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.42|||2-Sided|95.0|-0.9|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Bloating|
1658669|NCT01568112|3052421|Superiority or Other||Difference in percentage|0.2|Standard Error of the Mean|0.4|||2-Sided|95.0|-0.7|1.1||||||Bloating|
1658670|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.44|||2-Sided|95.0|-0.8|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation|
1658671|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.41|||2-Sided|95.0|-1.0|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Constipation|
1658825|NCT01565980|3052749|Superiority or Other||||||<|0.05||||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis||||
1658672|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.41|||2-Sided|95.0|-0.8|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion|
1658673|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.34|||2-Sided|95.0|-1.0|0.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Indigestion|
1658674|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.26|||2-Sided|95.0|-0.6|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting|
1658675|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.32|||2-Sided|95.0|-0.6|0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Vomiting|
1658676|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.46|||2-Sided|95.0|-1.1|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain|
1658677|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.48|||2-Sided|95.0|-1.0|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Lower abdominal pain|
1658678|NCT01568112|3052421|Superiority or Other||Mean Difference (Net)|0.3|Standard Error of the Mean|0.5|||2-Sided|95.0|-0.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain|
1658679|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.53|||2-Sided|95.0|-0.5|1.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Upper abdominal pain|
1658680|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.46|||2-Sided|95.0|-1.7|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea|
1658681|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.57|||2-Sided|95.0|-1.4|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Diarrhea|
1658682|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.49|||2-Sided|95.0|-1.1|0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea|
1658683|NCT01568112|3052421|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.53|||2-Sided|95.0|-1.1|1.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Nausea|
1658684|NCT01568112|3052422|Superiority or Other||Difference in percentage|1.0|||||2-Sided|95.0|-22.1|24.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658685|NCT01568112|3052422|Superiority or Other||Difference in percentage|-7.0|||||2-Sided|95.0|-29.4|17.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658686|NCT01568112|3052423|Superiority or Other||Difference in percentage|-3.0|||||2-Sided|95.0|-23.3|18.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658687|NCT01568112|3052423|Superiority or Other||Difference in percentage|-2.0|||||2-Sided|95.0|-24.2|19.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658688|NCT01568112|3052424|Superiority or Other||Difference in percentage|4.0|||||2-Sided|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658689|NCT01568112|3052424|Superiority or Other||Difference in percentage|0.0|||||2-Sided|95.0|-22.0|22.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658690|NCT01568112|3052425|Superiority or Other||Difference in percentage|-2.0|||||2-Sided|95.0|-24.7|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658691|NCT01568112|3052425|Superiority or Other||Difference in percentage|-20.0|||||2-Sided|95.0|-40.6|3.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658692|NCT01568112|3052426|Superiority or Other||Difference in percentage|7.0|||||2-Sided|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658693|NCT01568112|3052426|Superiority or Other||Difference in percentage|-22.0|||||2-Sided|95.0|-41.0|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.||
1658694|NCT01568112|3052427|Superiority or Other||Difference in percentage|7.0|||||2-Sided|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events|
1658695|NCT01568112|3052427|Superiority or Other||Difference in percentage|-12.0|||||2-Sided|95.0|-32.2|9.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events|
1658696|NCT01568112|3052428|Superiority or Other||Mean difference|-1.3|Standard Error of the Mean|0.58|||2-Sided|95.0|-2.4|-0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events|
1658697|NCT01568112|3052428|Superiority or Other||Mean difference|-0.8|Standard Error of the Mean|0.61|||2-Sided|95.0|-2.1|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events|
1658698|NCT01568112|3052428|Superiority or Other||Mean difference|-1.1|Standard Error of the Mean|0.54|||2-Sided|95.0|-2.2|0.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events|
1658699|NCT01568112|3052428|Superiority or Other||Mean difference|-1.0|Standard Error of the Mean|0.57|||2-Sided|95.0|-2.2|0.1|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events|
1658700|NCT01568112|3052428|Superiority or Other||Mean difference|-0.9|Standard Error of the Mean|0.56|||2-Sided|95.0|-2.1|0.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events|
1658701|NCT01568112|3052428|Superiority or Other||Mean difference|-0.8|Standard Error of the Mean|0.59|||2-Sided|95.0|-2.0|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events|
1658702|NCT01568112|3052428|Superiority or Other||Mean difference|-0.7|Standard Error of the Mean|0.61|||2-Sided|95.0|-1.9|0.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events|
1658703|NCT01568112|3052428|Superiority or Other||Mean difference|-0.7|Standard Error of the Mean|0.63|||2-Sided|95.0|-2.0|0.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events|
1658704|NCT01568112|3052428|Superiority or Other||Mean difference|-0.7|Standard Error of the Mean|0.57|||2-Sided|95.0|-1.8|0.4|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events|
1658705|NCT01568112|3052428|Superiority or Other||Mean difference|-0.5|Standard Error of the Mean|0.62|||2-Sided|95.0|-1.7|0.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events|
1658706|NCT01568112|3052429|Superiority or Other||Mean difference|1.2|Standard Error of the Mean|0.5|||2-Sided|95.0|0.2|2.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events|
1658707|NCT01568112|3052429|Superiority or Other||Mean difference|-1.9|Standard Error of the Mean|0.46|||2-Sided|95.0|-2.8|-1.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events|
1658708|NCT01568112|3052429|Superiority or Other||Mean difference|0.6|Standard Error of the Mean|0.52|||2-Sided|95.0|-0.4|1.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events|
1658709|NCT01568112|3052429|Superiority or Other||Mean difference|-1.8|Standard Error of the Mean|0.47|||2-Sided|95.0|-2.7|-0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events|
1658710|NCT01568112|3052429|Superiority or Other||Mean difference|1.2|Standard Error of the Mean|0.53|||2-Sided|95.0|0.1|2.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events|
1658711|NCT01568112|3052429|Superiority or Other||Mean difference|-1.7|Standard Error of the Mean|0.51|||2-Sided|95.0|-2.8|-0.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events|
1658712|NCT01568112|3052429|Superiority or Other||Mean difference|1.3|Standard Error of the Mean|0.62|||2-Sided|95.0|0.1|2.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events|
1658713|NCT01568112|3052429|Superiority or Other||Mean difference|-2.2|Standard Error of the Mean|0.5|||2-Sided|95.0|-3.2|-1.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events|
1658714|NCT01568112|3052429|Superiority or Other||Mean difference|1.2|Standard Error of the Mean|0.54|||2-Sided|95.0|0.2|2.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events|
1658715|NCT01568112|3052429|Superiority or Other||Mean difference|-1.9|Standard Error of the Mean|0.53|||2-Sided|95.0|-3.0|-0.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events|
1658716|NCT01568112|3052430|Superiority or Other||Difference in percentage|-18.0|||||2-Sided|95.0|-40.2|5.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events|
1658717|NCT01568112|3052430|Superiority or Other||Difference in percentage|-20.0|||||2-Sided|95.0|-40.6|3.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events|
1658718|NCT01568112|3052430|Superiority or Other||Difference in percentage|-11.0|||||2-Sided|95.0|-34.2|12.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events|
1658719|NCT01568112|3052430|Superiority or Other||Difference in percentage|-17.0|||||2-Sided|95.0|-38.1|6.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events|
1658720|NCT01568112|3052430|Superiority or Other||Difference in percentage|-5.0|||||2-Sided|95.0|-27.5|18.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events|
1658721|NCT01568112|3052430|Superiority or Other||Difference in percentage|-11.0|||||2-Sided|95.0|-33.0|11.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events|
1658722|NCT01568112|3052430|Superiority or Other||Difference in percentage|0.0|||||2-Sided|95.0|-22.9|23.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events|
1658723|NCT01568112|3052430|Superiority or Other||Difference in percentage|-14.0|||||2-Sided|95.0|-35.6|9.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events|
1658724|NCT01568112|3052430|Superiority or Other||Difference in percentage|-2.0|||||2-Sided|95.0|-24.7|21.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events|
1658725|NCT01568112|3052430|Superiority or Other||Difference in percentage|-14.0|||||2-Sided|95.0|-35.6|9.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events|
1658726|NCT01568112|3052431|Superiority or Other||Difference in percentage|18.0|||||2-Sided|95.0|-2.4|38.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events|
1658727|NCT01568112|3052431|Superiority or Other||Difference in percentage|-21.0|||||2-Sided|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Itching events|
1658728|NCT01568112|3052431|Superiority or Other||Difference in percentage|0.0|||||2-Sided|95.0|-21.0|21.0|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events|
1658729|NCT01568112|3052431|Superiority or Other||Difference in percentage|-33.0|||||2-Sided|95.0|-52.2|-10.6|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Tingling events|
1658730|NCT01568112|3052431|Superiority or Other||Difference in percentage|7.0|||||2-Sided|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events|
1658731|NCT01568112|3052431|Superiority or Other||Difference in percentage|-21.0|||||2-Sided|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Warmth events|
1658732|NCT01568112|3052431|Superiority or Other||Difference in percentage|7.0|||||2-Sided|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events|
1658733|NCT01568112|3052431|Superiority or Other||Difference in percentage|-19.0|||||2-Sided|95.0|-39.6|3.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Redness events|
1658734|NCT01568112|3052431|Superiority or Other||Difference in percentage|12.0|||||2-Sided|95.0|-9.5|32.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events|
1658735|NCT01568112|3052431|Superiority or Other||Difference in percentage|-14.0|||||2-Sided|95.0|-35.2|8.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events|
1658826|NCT01565980|3052750|Superiority or Other||||||<|0.05||||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis||||
1658736|NCT01568112|3052432|Superiority or Other||Difference in percentage|5.0|||||2-Sided|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall warmth events|
1658737|NCT01568112|3052432|Superiority or Other||Difference in percentage|-9.0|||||2-Sided|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall warmth events|
1658738|NCT01568112|3052432|Superiority or Other||Difference in percentage|12.0|||||2-Sided|95.0|-9.5|32.2|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall itching events|
1658739|NCT01568112|3052432|Superiority or Other||Difference in percentage|-14.0|||||2-Sided|95.0|-35.2|8.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall itching events|
1658740|NCT01568112|3052432|Superiority or Other||Difference in percentage|-3.0|||||2-Sided|95.0|-23.3|18.7|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall tingling events|
1658741|NCT01568112|3052432|Superiority or Other||Difference in percentage|-21.0|||||2-Sided|95.0|-41.7|1.3|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall tingling events|
1658742|NCT01568112|3052432|Superiority or Other||Difference in percentage|4.0|||||2-Sided|95.0|-16.4|25.5|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall redness events|
1658743|NCT01568112|3052432|Superiority or Other||Difference in percentage|-9.0|||||2-Sided|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall redness events|
1658744|NCT01568112|3052432|Superiority or Other||Difference in percentage|7.0|||||2-Sided|95.0|-14.1|27.8|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events|
1658745|NCT01568112|3052432|Superiority or Other||Difference in percentage|-9.0|||||2-Sided|95.0|-30.8|12.9|||||Reference arm is BG00012 240 mg BID; negative values means reduced side effect.|Overall flushing events|
1658746|NCT01567865|3052467|Non-Inferiority|The new GMP facility lots will be considered non-inferior (i.e., equivalent) to the existing facility lot if the null hypothesis is rejected and the alternate hypothesis is accepted.|Mean Difference (Net)|-4.03|||<|0.05|2-Sided|95.0|-9.74|3.1|||t-test, 2 sided|The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.||"Null hypothesis: reference lot vs. Lot 1, 2, and 3 combined do differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. The power of the study to test non-inferiority of the combined new lots compared to the reference lot dropped from 99% to 87%."|
1658747|NCT01567865|3052467|Equivalence|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|-4.33|||<|0.05|2-Sided|95.0|-11.94|3.31|||t-test, 2 sided|||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."|
1658748|NCT01567865|3052467|Equivalence|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|-2.48|||<|0.05|2-Sided|95.0|-9.92|4.98|||t-test, 2 sided|The 95% CI for the difference in rates is calculated based on the Newcombe-Wilson method without continuity correction.||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."|
1658749|NCT01567865|3052467|Equivalence|The 3 lots of new GMP facility LJEVac would be considered equivalent (i.e., the SP does not differ between lots by ≥10%) if all 3 null hypotheses are rejected, and the alternate hypotheses are accepted.|Mean Difference (Net)|1.84|||<||2-Sided|95.0|-5.97|9.66||||||"Null hypotheses: each new lot does not differ in seroprotection (SP) rates among each other by more than 10%.~Slower than anticipated enrollment resulted in a smaller number of subjects with antibody response data for analysis. Consequently, additional power estimates were made in anticipation of the occurrence of smaller sample sizes. With a total study population of only 772 subjects, the power of the study to test lot-to-lot consistency declined from 90% to 85%."|
1658750|NCT01567826|3052477|Superiority or Other|||||||0.02|||||||ANCOVA||||
1658751|NCT01567826|3052478|Superiority or Other|||||||0.01|||||||ANCOVA||||
1658752|NCT01567527|3052481|Superiority|Using the Cox proportional hazards model with term for treatment group.|Hazard Ratio (HR)|7.313|||||2-Sided|95.0|2.151|24.865|||||HR is estimated for Placebo relative to Aripiprazole IM depot.||
1658753|NCT01567527|3052481|Superiority||Hazard Ratio (HR)|0.137|||=|0|2-Sided|95.0|0.04|0.465|||Log Rank||"Using the Cox proportional hazards model with term for treatment group.~HR is estimated for Aripiprazole IM depot relative to Placebo."||
1658754|NCT01567527|3052482|Superiority|Using mixed model repeated measures (MMRM) analysis with a restricted maximum likelihood (REML) approach. Analyses included the categorically fixed effects of treatment, region, trial week, and treatment-by-week interaction, as well as the continuously fixed covariates of baseline-score-by-week interaction. An unstructured covariance structure was used to model the within-subject errors and Kenward-Rodger degree of freedom was used to test the fixed effects.|Mean Difference (Final Values)|-0.43|||=|0|2-Sided|95.0|-0.69|-0.17|||Mixed model repeated measure analysis||||
1658755|NCT01567527|3052483|Superiority|Using a hierarchical procedure to preserve the overall Type I error rate at 0.05, after testing the primary outcome.|Percentage Difference (Final Values)|-24.6|||<|0.0001|2-Sided|95.0|-36.7|-12.5|||Fisher Exact|||Statistical analysis for any mood episode|
1658756|NCT01567527|3052484|Superiority|Using the Cox proportional hazards model with term for treatment group.|Hazard Ratio (HR)|2.22|||||2-Sided|95.0|1.475|3.34|||||HR is estimated for Placebo relative to Aripiprazole IM depot.||
1658757|NCT01567527|3052484|Superiority||Hazard Ratio (HR)|0.451|||<|0.0001|2-Sided|95.0|0.299|0.678|||Log Rank||"Using the Cox proportional hazards model with term for treatment group.~HR is estimated for Aripiprazole IM depot relative to Placebo."|Significance level 0.05.|
1658758|NCT01567163|3052496|Superiority or Other||Ratio of geometric least squares means|1.14|||||2-Sided|90.0|0.84|1.55|||||The ratio of geometric least squares means was calculated using a mixed effect model adjusted for cycle, participant and random error. Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1.||
1658759|NCT01567163|3052498|Superiority or Other||Ratio geometric least squares (LS) means|0.97|||||2-Sided|90.0|0.84|1.1|||||The ratio of geometric LS means was calculated using a mixed effect model adjusted for cycle, participant and random error. Ratio of geometric LS means is AUC(0-∞) of Cycle 2/Cycle 1.||
1658760|NCT01567085|3052504|Other|Exact binomial test|||||<|0.001||||||The p-value was calculated from an exact binomial test, where the null hypothesis was that the true failure rate = 40%.|Exact binomial test|Exact 95% confidence interval (3.6, 17.2)||Analysis of post-transplantation treatment failure rate|
1658761|NCT01566981|3052516|Superiority or Other||Mean Difference (Final Values)|0.6925|Standard Deviation|1.4708||0.005|2-Sided|95.0|0.2221|1.1629|||t-test, 2 sided|without adjustments, df=39||"Null hypothesis was that Information and Communication Technology (ICT) supported diabetes care could have significant impact on reduction of baseline glycated hemoglobin (EHbA1c) after 1 year follow-up.~The sample in intervention group was normally distributed, so observed power (two-tailed hypothesis) was 0.45, for Cohen's d= 0.6 and alpha level =0.05"|
1658762|NCT01566695|3052562|Superiority|||||||0.683|||||||Fisher Exact||||
1658763|NCT01566695|3052563|Superiority|||||||0.436|||||||Fisher Exact||||
1658764|NCT01566695|3052564|Superiority|||||||0.07|||||||Fisher Exact||||
1658765|NCT01566695|3052565|Superiority|||||||0.601|||||||Fisher Exact||||
1658766|NCT01566695|3052566|Superiority|||||||0.972|||||||Fisher Exact||||
1658767|NCT01566695|3052567|Superiority|||||||0.198|||||||Fisher Exact||||
1658768|NCT01566695|3052568|Superiority|||||||0.063|||||||Fisher Exact||||
1658769|NCT01566695|3052569|Superiority|||||||0.442|||||||Fisher Exact||||
1658770|NCT01566695|3052570|Superiority|||||||0.324|||||||Fisher Exact||||
1658771|NCT01566695|3052571|Superiority|||||||0.134|||||||Fisher Exact||||
1658772|NCT01566695|3052572|Superiority|||||||0.046|||||||Fisher Exact||||
1658773|NCT01566695|3052573|Superiority||||||<|0.001|||||||Fisher Exact||||
1658774|NCT01566695|3052574|Superiority||Common Odds Ratio|1.86||||0.153|2-Sided|95.0|0.79|4.34|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.
1658775|NCT01566695|3052575|Superiority||Common Odds Ratio|2.03||||0.082|2-Sided|95.0|0.92|4.48|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.
1658776|NCT01566695|3052576|Superiority||Common Odds Ratio|1.65||||0.249|2-Sided|95.0|0.71|3.83|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.
1658777|NCT01566695|3052577|Superiority||Common Odds Ratio|1.58||||0.222|2-Sided|95.0|0.76|3.29|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.
1658778|NCT01566695|3052578|Superiority||Common Odds Ratio|2.0||||0.075|2-Sided|95.0|0.93|4.3|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.
1658779|NCT01566695|3052579|Superiority||Common Odds Ratio|2.14||||0.121|2-Sided|95.0|0.82|5.57|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.
1658780|NCT01566695|3052580|Superiority||Common Odds Ratio|1.67||||0.197|2-Sided|95.0|0.76|3.65|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.
1658781|NCT01566695|3052581|Superiority||Common Odds Raatio|0.72||||0.48|2-Sided|95.0|0.29|1.78|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.
1658782|NCT01566695|3052582|Superiority||Common Odds Raatio|0.77||||0.56|2-Sided|95.0|0.54|1.3|||Cochran-Mantel-Haenszel|The p-value was calculated based on the CMH tests for comparing the odds of experiencing CMI between CC-486 versus placebo.|||The common odds ratio and the 95% confidence interval (CI) were calculated using CMH tests, stratified by randomization stratification factors, to compare the odds of experiencing clinically meaningful improvement between CC-486 and placebo.
1658783|NCT01566695|3052583|Superiority|||||||0.073|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.|||
1658784|NCT01566695|3052584|Superiority|||||||0.078|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.|||
1658785|NCT01566695|3052585|Superiority|||||||0.069|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.|||
1658786|NCT01566695|3052586|Superiority|||||||0.123|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.|||
1658787|NCT01566695|3052587|Superiority|||||||0.13|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.|||
1658788|NCT01566695|3052588|Superiority|||||||0.058|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.|||
1658789|NCT01566695|3052589|Superiority|||||||0.248|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.|||
1658790|NCT01566695|3052590|Superiority|||||||0.446|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.|||
1658791|NCT01566695|3052591|Superiority|||||||0.214|||||||t-test, 2 sided|The p-value was calculated based on a pooled 2-sample, 2-sided t-test for the difference in mean change from baseline between treatment groups.|||
1658792|NCT01566695|3052600|Superiority||Rate Difference|17.0||||0.0007|2-Sided|95.0|7.5|26.4|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus >4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2|||
1658793|NCT01566695|3052601|Superiority|RBC Transfusion Reduction|Rate Difference|10.9||||0.1431|2-Sided|95.0|-1.9|23.6|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus >4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2|||
1658794|NCT01566695|3052601|Superiority|≥ 1.5 g/dL Hemoglobin Increase|Rate Diffrence|17.9||||0.0002|2-Sided|95.0|8.8|26.9|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus >4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2|||
1658795|NCT01566695|3052601|Superiority|HI-E|Rate Difference|10.9||||0.1467|2-Sided|95.0|-2.0|23.7|||Stratified Mantel-Haenszel. Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus >4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2|||
1658796|NCT01566695|3052603|Superiority|||||||0.4347|||||||Two-Sided Unstratified Log Rank Test||||
1658797|NCT01566695|3052604|Superiority||Rate Difference|21.6|||<|0.0001|2-Sided|95.0|11.9|31.3||2 sided|Stratified Mantel-Haenszel; Chi-squared|Stratified by average BL RBC tfx needs: ≤4 units versus >4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2|||
1658798|NCT01566695|3052607|Superiority|||||||0.7547|||||||Two-sided Unstratified Log Rank Test||||
1658799|NCT01566695|3052608|Superiority||Rate Difference|18.9||||0.0005|2-Sided|95.0|8.3|29.6||2 sided|Stratified Mantel-Haenszel Chi-squared|Stratified by average baseline (BL) RBC tfx needs: ≤4 units versus >4 units; BL platelet tfx status: dependent or independent and ECOG PS: 0 to 1 vs 2|||
1658800|NCT01566461|3052668|Superiority or Other|||||||0.049|||||||t-test, 1 sided||||
1658801|NCT01566461|3052669|Superiority or Other|||||||0.103|||||||Chi-squared||||
1658802|NCT01566461|3052670|Superiority or Other|||||||0.111|||||||Chi-squared||||
1658803|NCT01566461|3052671|Superiority or Other|||||||0.302|||||||Chi-squared||||
1658804|NCT01566461|3052672|Superiority or Other|||||||0.59|||||||t-test, 1 sided||||
1658805|NCT01566461|3052673|Superiority or Other|||||||0.878|||||||t-test, 1 sided||||
1658806|NCT01566461|3052674|Superiority or Other|||||||0.095|||||||t-test, 1 sided||||
1658807|NCT01566461|3052675|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1658808|NCT01566461|3052676|Superiority or Other|||||||0.001|||||||Chi-squared||||
1658809|NCT01566461|3052677|Superiority or Other|||||||0.121|||||||Chi-squared||||
1658810|NCT01566461|3052678|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1658811|NCT01566461|3052679|Superiority or Other|||||||0.096|||||||Chi-squared||||
1658812|NCT01566461|3052680|Superiority or Other||||||>|0.999|||||||Chi-squared||||
1658813|NCT01566461|3052681|Superiority or Other|||||||0.859|||||||t-test, 1 sided||||
1658814|NCT01566461|3052682|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1658815|NCT01566461|3052683|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1658816|NCT01566461|3052684|Superiority or Other|||||||0.926|||||||Chi-squared||||
1658817|NCT01566461|3052685|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1658818|NCT01566461|3052686|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1658819|NCT01566461|3052687|Superiority or Other||||||<|0.001|||||||z-test||||
1658820|NCT01566409|3052701|Non-Inferiority or Equivalence|The required sample size was based on a projected treatment success in the PEG group of 60%. With a power in excess of 80% and a critical level of significance of 0.05, 45 children were needed in each group to detect a 50% reduction in treatment effect in the placebo group, corresponding to 30% recovers without active maintenance treatment. Because of an expected drop-out rate of 25%, we aimed at including 115 children.||||||0.024|||||||Regression, Logistic||||
1658821|NCT01565980|3052745|Superiority or Other||||||<|0.05||||||P values above 0.05 are considered statistically insignificant in this study.|Descriptive statistics for outcomes||||
1658822|NCT01565980|3052746|Superiority or Other||||||<|0.05||||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis||||
1658823|NCT01565980|3052747|Superiority or Other||||||<|0.05||||||P values below 0.05 are considered statistically significant in this study.|Mixed Models Analysis||||
1658827|NCT01565980|3052751|Superiority or Other||||||<|0.05||||||P-values for the comparison of least square (LS) means represent the effect of the trial arm. The effect sizes are calculated as Cohen’s d: difference between LS means divided by the standard deviation.|Mixed Models Analysis|||The outcome measure was analyzed using linear mixed effects models (LME). The main effect of the trial arm was evaluated by averaging time 2 and time 3 values of the outcomes within the LME model. The resulting least square (LS) means and their standard errors are reported.|
1658828|NCT01565850|3052791|Superiority or Other||Difference in LSM|18.0||||0.5|2-Sided|95.0|-35.0|72.0||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or > 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA||||
1658829|NCT01565850|3052792|Superiority or Other||Difference in LSM|45.0||||0.11|2-Sided|95.0|-10.0|101.0||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or > 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA||||
1658830|NCT01565850|3052793|Superiority or Other||Difference in LSM|0.06||||0.5|2-Sided|95.0|-0.11|0.23||The p-value, difference in LSM, and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or > 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA||||
1658831|NCT01565850|3052794|Superiority or Other||Difference in LSM|0.04||||0.67|2-Sided|95.0|-0.14|0.21||The p-value, difference in least squares mean (LSM), and its 95% CI were from ANOVA model with baseline HIV-1 RNA level (≤ 100,000 or > 100,000 copies/mL) and race (Black or non-Black) as fixed effects in the model.|ANOVA||||
1658832|NCT01565850|3052795|Non-Inferiority or Equivalence|The null hypothesis was that the D/C/F/TAF group is at least 12% worse than the DRV+COBI+FTC/TDF group with respect to the percentage of participants achieving HIV-1 RNA < 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the D/C/F/TAF group is less than 12% worse than that in the DRV+COBI +FTC/TDF group.|Difference in proportions|-6.2||||0.35|2-Sided|95.0|-19.9|7.4||The p-value for the superiority test comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel test stratified by baseline HIV-1 RNA and race strata.|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% CI were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel proportion.||
1658833|NCT01565850|3052796|Non-Inferiority or Equivalence|A total sample size of 150 HIV-1 infected participants, randomized in a 2:1 ratio to 2 groups, would achieve 56% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA < 50 copies/mL at Week 24 if a response rate of 0.88 for both arms, a noninferiority margin of 0.12, and the significance level of the test at a one-sided 0.025 level were assumed.|Difference in proportions|3.3||||0.64|2-Sided|95.0|-11.4|18.1||The p-value for the superiority test comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel test stratified by baseline HIV-1 RNA and race strata.|Cochran-Mantel-Haenszel||The difference in percentages of virologic success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel proportion.|The null hypothesis was that the D/C/F/TAF group is at least 12% worse than the DRV+COBI+FTC/TDF group with respect to the percentage of participants achieving HIV-1 RNA < 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 24; the alternative hypothesis was that the response rate in the D/C/F/TAF group is less than 12% worse than that in the DRV+COBI +FTC/TDF group.|
1658834|NCT01565707|3052806|Superiority or Other||Adjusted Mean Difference|-0.3|Standard Error of the Mean|0.5|||2-Sided|95.0|-1.4|0.8|||||From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.||
1658835|NCT01565707|3052807|Superiority or Other||Adjusted Mean Difference|-0.2|Standard Error of the Mean|0.4|||2-Sided|95.0|-1.0|0.5|||||From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.||
1658836|NCT01565707|3052807|Superiority or Other||Adjusted Mean Difference|-0.1|Standard Error of the Mean|0.1||0.846|2-Sided|95.0|-0.3|0.1||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.|||
1658837|NCT01565707|3052808|Superiority or Other||Adjusted Mean Difference|0.3|Standard Error of the Mean|0.6|||2-Sided|95.0|-0.9|1.4|||||From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.||
1658838|NCT01565707|3052808|Superiority or Other||Adjusted Mean Difference|-0.1|Standard Error of the Mean|0.3||0.64|2-Sided|95.0|-0.8|0.5|||ANCOVA|From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.|||
1658839|NCT01565707|3052809|Superiority or Other||Adjusted Mean Difference|0.1|Standard Error of the Mean|0.5|||2-Sided|95.0|-0.9|1.1|||||From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.||
1658840|NCT01565707|3052809|Superiority or Other||Adjusted Mean Difference|-0.3|Standard Error of the Mean|0.2||0.303|2-Sided|95.0|-0.8|0.2||From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.|ANCOVA||||
1658841|NCT01565707|3052810|Superiority or Other||Adjusted Mean Difference|0.5|Standard Error of the Mean|0.4|||2-Sided|95.0|-0.4|1.3|||||From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.||
1658842|NCT01565707|3052810|Superiority or Other||Adjusted Mean Difference|-0.3|Standard Error of the Mean|0.3||0.77|2-Sided|95.0|-0.9|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.|||
1658843|NCT01565707|3052811|Superiority or Other||Adjusted Mean Difference|0.1|Standard Error of the Mean|0.8|||2-Sided|95.0|-1.6|1.9|||||From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.||
1658844|NCT01565707|3052811|Superiority or Other||Adjusted Mean Difference|-0.4|Standard Error of the Mean|0.3||0.563|2-Sided|95.0|-1.0|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.|||
1658872|NCT01565694|3052826|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.003|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.|
1658845|NCT01565707|3052812|Superiority or Other||Adjusted Mean Difference|0.0|Standard Error of the Mean|0.1|||2-Sided|95.0|-0.2|0.2|||||From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate..||
1658846|NCT01565707|3052812|Superiority or Other||Adjusted Mean Difference|0.1|Standard Error of the Mean|0.1||0.63|2-Sided|95.0|0.0|0.2||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.|||
1658847|NCT01565707|3052813|Superiority or Other||Adjusted Mean Difference|-0.6|Standard Error of the Mean|0.5|||2-Sided|95.0|-1.5|0.4|||||From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.||
1658848|NCT01565707|3052813|Superiority or Other||Adjusted Mean Difference|-0.1|Standard Error of the Mean|0.2||0.402|2-Sided|95.0|-0.5|0.3||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.|||
1658849|NCT01565707|3052814|Superiority or Other||Adjusted Mean Difference|0.1|Standard Error of the Mean|0.4|||2-Sided|95.0|-0.8|1.0|||||From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.||
1658850|NCT01565707|3052814|Superiority or Other||Adjusted Mean Difference|0.0|Standard Error of the Mean|0.2||0.763|2-Sided|95.0|-0.3|0.4||P-value is from a rank ANCOVA analysis stratified by geographic region.|ANCOVA|From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.|||
1658851|NCT01565707|3052815|Superiority or Other||Adjusted Mean Difference|-17.3|Standard Error of the Mean|29.1|||2-Sided|95.0|-76.5|41.9|||||From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.||
1658852|NCT01565707|3052815|Superiority or Other||Adjusted Mean Difference|31.9|Standard Error of the Mean|13.9||0.024|2-Sided|95.0|4.3|59.5|||ANCOVA|From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.|||
1658853|NCT01565707|3052816|Superiority or Other||Adjusted Mean Difference|-4.7|Standard Error of the Mean|15.7|||2-Sided|95.0|-36.7|27.4|||||From an ANCOVA model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.||
1658854|NCT01565707|3052816|Superiority or Other||Adjusted Mean Difference|12.1|Standard Error of the Mean|6.0||0.046|2-Sided|95.0|0.2|24.0|||ANCOVA|From an ANCOVA (analysis of covariance) model including treatment, geographic region & gender as fixed effects & the baseline value as a covariate.||"The following hypotheses were tested at the 2-sided significance level 0.05:~H0: Change from baseline to EoT in mean MVV per micturition is the same for placebo and solifenacin succinate oral suspension~H1: Change from baseline to EoT in mean MVV per micturition is not the same for placebo and solifenacin succinate oral suspension"|
1658855|NCT01565694|3052818|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.573|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.|
1658856|NCT01565694|3052818|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.568|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.|
1658857|NCT01565694|3052819|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.|
1658858|NCT01565694|3052819|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.|
1658859|NCT01565694|3052820|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.004|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.|
1658860|NCT01565694|3052820|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.01|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.|
1658861|NCT01565694|3052821|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.|
1658862|NCT01565694|3052821|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.|
1658863|NCT01565694|3052822|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.|
1658864|NCT01565694|3052822|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.|
1658865|NCT01565694|3052823|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.|
1658866|NCT01565694|3052823|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.|
1658867|NCT01565694|3052824|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.|
1658868|NCT01565694|3052824|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.|
1658869|NCT01565694|3052825|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.075|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.|
1658870|NCT01565694|3052825|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.068|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.|
1658871|NCT01565694|3052826|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.028|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.|
1658873|NCT01565694|3052827|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.004|||||||t-test, 2 sided|||Analysis of change from baseline to week 24 LOCF in bladder volume at 40 cmH20.|
1658874|NCT01565694|3052827|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.001|||||||t-test, 2 sided|||Analysis of change from baseline to week 24 in bladder volume at 40 cmH20.|
1658875|NCT01565694|3052828|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF in bladder volume at 30 cmH20.|
1658876|NCT01565694|3052828|Other|P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0||||||0.006|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 in bladder volume at 30 cmH20.|
1658877|NCT01565694|3052829|Other|From a Wilcoxon Signed Rank testing the null hypothesis is that the Median at Week 24 is equal to Baseline Median.|||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Analysis of change from baseline to Week 24.|
1658878|NCT01565694|3052830|Other|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.026|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.|
1658879|NCT01565694|3052830|Other|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.||||||0.029|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.|
1658880|NCT01565694|3052831|Other|P-Value was obtained from a 2-sided one sample t-test, testing the null hypothesis that Change from Baseline=0.|||||<|0.001|||||||t-test, 2 sided||||
1658881|NCT01565694|3052832|Other|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24 LOCF.|
1658882|NCT01565694|3052832|Other|P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.|||||<|0.001|||||||t-test, 2 sided|||Analysis of change from baseline to Week 24.|
1658883|NCT01565616|3052851|Other||Mean Difference (Net)|-0.5|Standard Deviation|3.1||0.53|2-Sided||||||t-test, 2 sided|||This statistical analysis is the paired difference in raw scores of the pain intensity domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.|
1658884|NCT01565616|3052851|Other||Mean Difference (Net)|0.5|Standard Deviation|13.5||0.88|2-Sided||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the sleep disturbances domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.|
1658885|NCT01565616|3052851|Other||Mean Difference (Net)|0.6|Standard Deviation|11.8||0.85|2-Sided||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the satisfaction with social role domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.|
1658886|NCT01565616|3052851|Other||Mean Difference (Net)|5.8|Standard Deviation|10.5||0.044|2-Sided||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the physical function domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.|
1658887|NCT01565616|3052851|Other||Mean Difference (Net)|-7.5|Standard Deviation|9.3||0.006|2-Sided||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the pain interference domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.|
1658888|NCT01565616|3052851|Other||Mean Difference (Net)|-1.3|Standard Deviation|8.5||0.54|2-Sided||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the fatigue domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.|
1658889|NCT01565616|3052851|Other||Mean Difference (Net)|2.7|Standard Deviation|6.4||0.12|2-Sided||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the depression domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.|
1658890|NCT01565616|3052851|Other||Mean Difference (Net)|-1.7|Standard Deviation|10.4||0.52|2-Sided||||||t-test, 2 sided|||This statistical analysis is the paired difference in t-scores of the anxiety domain of the PROMIS-57 quality of life scale. 16 participants with paired measurements of the PROMIS-57 survey (baseline and 1 year) are included in this analysis.|
1658891|NCT01565369|3052867|Superiority or Other||Fleiss' kappa|0.8547|Standard Error of the Mean|0.0282|<|0.0001||95.0||||evaluated at the .05 significance level|Fleiss' kappa|||Fleiss' kappa|
1658892|NCT01565356|3052871|Superiority or Other||Kappa statistic|1.0|||||2-Sided|95.0|1.0|1.0||||||Cohen's (simple) kappa statistic|
1658893|NCT01565343|3052872|Superiority or Other||Mean % difference|1.49|Standard Deviation|0.839||||95.0||||||||Intra-subject variability (% difference) of control subjects 50-70 min test vs. retest values|
1658894|NCT01565343|3052872|Superiority or Other||Mean % difference|2.35|Standard Deviation|1.413||||95.0||||||||Intra-subject variability (% difference) of AD subjects 50-70 min test vs. retest values|
1658895|NCT01565343|3052872|Superiority or Other||ICC|0.9574||||||95.0||||||||Intra-class Correlation Coefficient of Control subjects 50-70 min test vs. retest values|
1658896|NCT01565343|3052872|Superiority or Other||ICC|0.9893||||||95.0||||||||Intra-class Correlation Coefficient (ICC) of AD subjects 50-70 min test vs. retest values|
1658897|NCT01564862|3052916|Superiority or Other||LS mean difference|-0.404|Standard Error of the Mean|0.1194|<|0.001|2-Sided|95.0|-0.638|-0.169||P-value was from a MMRM model with baseline*week, center, week, treatment and week*treatment as factors in the analysis.|Mixed Models Analysis||||
1658898|NCT01564862|3052916|Superiority or Other||LS Mean difference|-0.29|Standard Error of the Mean|0.1211|<|0.017|2-Sided|95.0|-0.528|-0.052||P-value was from a MMRM model with baseline*week, center, week, treatment and week*treatment as factors in the analysis.|Mixed Models Analysis||||
1658929|NCT01564537|3052956|Superiority or Other (legacy)||Hazard Ratio (HR)|0.742||||0.012|2-Sided|95.0|0.587|0.939|||Log Rank||HR is estimated from Cox Regression.||
1658899|NCT01564862|3052917|Superiority or Other||LS mean difference|-3.0|Standard Error of the Mean|0.77|<|0.001|2-Sided|95.0|-4.5|-1.5||P-value was from a MMRM model with baseline*week, center, week, treatment and week*treatment as factors in the analysis.|Mixed Models Analysis||||
1658900|NCT01564862|3052917|Superiority or Other||LS Mean difference|-2.6|Standard Error of the Mean|0.78|<|0.001|2-Sided|95.0|-4.1|-1.0||P-value was from a MMRM model with baseline*week, center, week, treatment and week*treatment as factors in the analysis.|Mixed Models Analysis||||
1658901|NCT01564862|3052918|Superiority or Other||LS mean difference|0.54|Standard Error of the Mean|0.725||0.46|2-Sided|95.0|-0.89|1.96||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA||||
1658902|NCT01564862|3052918|Superiority or Other||LS mean difference|1.21|Standard Error of the Mean|0.733||0.099|2-Sided|95.0|-0.23|2.65||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA||||
1658903|NCT01564862|3052918|Superiority or Other||LS mean difference|1.75|Standard Error of the Mean|0.744||0.019|2-Sided|95.0|0.28|3.21||P-value was from an ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.|ANCOVA||||
1658904|NCT01564784|3052920|Superiority or Other||Mean Difference (Net)|4.6||||0.1172|2-Sided|95.0|-1.2|10.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.|||
1658905|NCT01564784|3052921|Superiority or Other||Mean Difference (Net)|0.03||||0.171|2-Sided|95.0|-0.01|0.07|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.|||
1658906|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|-0.7||||0.8428|2-Sided|95.0|-7.3|6.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Pain|
1658907|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|-1.6||||0.4578|2-Sided|95.0|-6.0|2.7|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Nausea and Vomiting|
1658908|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|-4.4||||0.1789|2-Sided|95.0|-10.8|2.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Fatigue|
1658909|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|-2.5||||0.4915|2-Sided|95.0|-9.7|4.7|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Financial Difficulties|
1658910|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|-3.0||||0.1534|2-Sided|95.0|-7.2|1.1|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Diarrhoea|
1658911|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|1.4||||0.6249|2-Sided|95.0|-4.4|7.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Constipation|
1658912|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|-8.7||||0.0193|2-Sided|95.0|-16.0|-1.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Appetite Loss|
1658913|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|-1.7||||0.6207|2-Sided|95.0|-8.7|5.2|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Insomnia|
1658914|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|-4.7||||0.1281|2-Sided|95.0|-10.8|1.4|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Dyspnoea|
1658915|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|4.3||||0.1572|2-Sided|95.0|-1.7|10.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Global Health Status|
1658916|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|8.4||||0.0336|2-Sided|95.0|0.7|16.1|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Social Functioning|
1658917|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|2.8||||0.1904|2-Sided|95.0|-1.4|7.0|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Cognitive Functioning|
1658918|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|-2.3||||0.3307|2-Sided|95.0|-6.9|2.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Emotional Functioning|
1658919|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|11.4||||0.0065|2-Sided|95.0|3.2|19.5|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Role Functioning|
1658920|NCT01564784|3052922|Superiority or Other||Mean Difference (Net)|6.9||||0.0139|2-Sided|95.0|1.4|12.3|||Mixed Models Analysis|Treatment, time, treatment-by-time interaction, and baseline included as covariate.||Physical Functioning|
1658921|NCT01564784|3052924|Superiority or Other|||||||0.216|||||||1-sided p-value based on Chi-Square test|If any cell count is <5, p-value was based on Fisher's exact test||Abnormal after remission|
1658922|NCT01564784|3052924|Superiority or Other|||||||0.3168|||||||1-sided p-value based on Chi-Square test|If any cell count is <5, p-value was based on Fisher's exact test||Abnormal at Screening|
1658923|NCT01564784|3052925|Superiority or Other||||||<|0.0001|||||||1-sided p-value based on Chi-Square test|If any cell count is <5, p-value was based on Fisher's exact test|||
1658924|NCT01564784|3052926|Superiority or Other||Rate difference|31.6|||<|0.0001|2-Sided|95.0|22.6|40.6|||1-sided p-value based on Chi-square test|If any cell count was <5, p-value was based on Fisher's exact test|||
1658925|NCT01564784|3052927|Superiority or Other||Hazard Ratio (HR)|0.45|||<|0.0001|2-Sided|97.5|0.336|0.602|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.||
1658926|NCT01564784|3052928|Superiority or Other||Hazard Ratio (HR)|0.49||||0.0021|2-Sided|95.0|0.297|0.809|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.||
1658927|NCT01564784|3052929|Superiority or Other||Hazard Ratio (HR)|0.751||||0.0105|2-Sided|97.5|0.568|0.993|||1-sided stratified log-rank p-value||Stratified HR, i.e., based on analysis stratified by randomization stratification factors.||
1658928|NCT01564784|3052930|Superiority or Other||Rate difference|51.4|||<|0.0001|2-Sided|97.5|38.4|64.3|||1-sided p-value based on Chi-square test|If any cell count was <5, p-value was based on Fisher's exact test|||
1658930|NCT01564459|3052959|Superiority or Other||Difference in Least Squares Means|-0.687||||0.108|2-Sided|95.0|-1.527|0.154|||Constrained longitudinal data analysis|terms for treatment, time and treatment-by-time interaction|||
1658931|NCT01564459|3052960|Superiority or Other||Difference in Least Squares Means|-0.587||||0.269|2-Sided|95.0|-1.637|0.464|||Constrained longitudinal data analysis|terms for treatment, time and treatment-by-time interaction|||
1658932|NCT01563978|3052980|Superiority or Other||Least square means treatment difference|0.74|||<|0.001|2-Sided|95.0|0.4|1.08||Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)|ANCOVA|||Improvement from baseline at Day 29. Non-responder imputation has been applied following premature withdrawal, or any dose of background disease modifying antirheumatic drug increased or any other RA treatment initiated including DMARDs, anti-TNFs or other biologics, or receiving any parenteral steroids, or for patients with no post baseline data.|
1658933|NCT01563978|3052982|Superiority or Other||Least square means treatment difference|4.74|||<|0.001|2-Sided|95.0|2.9|6.59|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in weekly average post-dose home DBP (Week 4)|
1658934|NCT01563978|3052982|Superiority or Other||Least square means treatment difference|7.22|||<|0.001|2-Sided|95.0|4.29|10.16|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in weekly average post-dose home SBP (Week 4)|
1658935|NCT01563978|3052983|Superiority or Other||Least square means treatment difference|4.58|||<|0.001|2-Sided|95.0|2.91|6.25|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in weekly average pre-dose home DBP (Week 4)|
1658936|NCT01563978|3052983|Superiority or Other||Least square means treatment difference|6.31|||<|0.001|2-Sided|95.0|3.6|9.03|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in weekly average pre-dose home SBP (Week 4)|
1658937|NCT01563978|3052984|Superiority or Other||Least square means treatment difference|2.36||||0.046|2-Sided|95.0|0.05|4.68|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in clinic DBP (Day 29)|
1658938|NCT01563978|3052984|Superiority or Other||Least square means treatment difference|2.24||||0.2|2-Sided|95.0|-1.2|5.69|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in clinic SBP (Day 29)|
1658939|NCT01563978|3052985|Superiority or Other||Least square means treatment difference|2.87||||0.007|2-Sided|95.0|0.81|4.93|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in mean sleeping DBP|
1658940|NCT01563978|3052985|Superiority or Other||Least squares mean treatment difference|1.99||||0.223|2-Sided|95.0|-1.22|5.2|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in mean sleeping SBP|
1658941|NCT01563978|3052986|Superiority or Other||Least square means treatment difference|3.66|||<|0.001|2-Sided|95.0|2.1|5.22|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in mean awake DBP (Day 28)|
1658942|NCT01563978|3052986|Superiority or Other||Least square means treatment difference|3.11|||<|0.024|2-Sided|95.0|0.41|5.81|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in mean awake SBP (Day 28)|
1658943|NCT01563978|3052987|Superiority or Other||Least square means treatment difference|3.14||||0.002|2-Sided|95.0|1.13|5.14|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in mean night-time DBP (Day 28)|
1658944|NCT01563978|3052987|Superiority or Other||Least square means treatment difference|2.07||||0.179|2-Sided|95.0|-0.96|5.11|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in mean night-time SBP (Day 28)|
1658945|NCT01563978|3052987|Superiority or Other||Least square means treatment difference|3.75|||<|0.001|2-Sided|95.0|2.08|5.42|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in mean daytime DBP (Day 28)|
1658946|NCT01563978|3052987|Superiority or Other||Least square means treatment difference|3.3|||<|0.02|2-Sided|95.0|0.53|6.08|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)||Change from baseline in mean daytime SBP (Day 28)|
1658947|NCT01563978|3052988|Superiority or Other||Least squares mean treatment difference|3.53|||<|0.001|2-Sided|95.0|2.04|5.03|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)|||
1658948|NCT01563978|3052989|Superiority or Other||Least squares mean treatment difference|2.93||||0.023|2-Sided|95.0|0.4|5.45|||ANCOVA|Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors)|||
1658949|NCT01563536|3052994|Superiority or Other||Mean Difference (Maximal Decrease)|-1.5||||0.035|2-Sided|95.0|-2.81|-0.13||Pre-specified 2-sided significance level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) with the baseline log10 HCV RNA values as a covariate and with an effect for treatment arm.|||
1658950|NCT01563198|3053008|Superiority||||||<|0.0001|||||||Chi-squared||||
1658951|NCT01563198|3053009|Superiority||||||<|0.0001|||||||Chi-squared||||
1658952|NCT01563198|3053010|Superiority||||||<|0.0001|||||||Chi-squared|||Change in Non-completion Rate of MRI Scans From Baseline at Average of One Year (All Schedule Patients)|
1658953|NCT01563172|3053022|Superiority or Other||LS mean difference|1294.34|||<|0.0001|2-Sided|95.0|1069.24|1519.43||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."||
1658954|NCT01563172|3053023|Superiority or Other||LS mean difference|-574.79|||<|0.0001|2-Sided|95.0|-808.08|-341.5||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."||
1658955|NCT01563172|3053024|Superiority or Other||LS mean difference|-822.88|||<|0.0001|2-Sided|95.0|-1047.34|-598.42||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."||
1658956|NCT01563172|3053025|Superiority or Other||LS Mean difference|265.92||||0.0218|2-Sided|95.0|39.0|492.83||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."||
1658957|NCT01563172|3053026|Superiority or Other||LS Mean Difference|514.01|||<|0.0001|2-Sided|95.0|283.02|744.99||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."||
1658958|NCT01563172|3053027|Superiority or Other||LS mean difference|15.38|||<|0.0001|2-Sided|95.0|11.45|19.31||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."||
1658959|NCT01563172|3053028|Superiority or Other||LS mean difference|-9.61|||<|0.0001|2-Sided|95.0|-13.68|-5.54||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."||
1658960|NCT01563172|3053029|Superiority or Other||LS mean difference|-10.86|||<|0.0001|2-Sided|95.0|-14.77|-6.94||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."||
1658961|NCT01563172|3053030|Superiority or Other||LS mean difference|5.7||||0.0049|2-Sided|95.0|1.74|9.66||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from ANOVA with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."||
1658962|NCT01563172|3053031|Superiority or Other||Least square (LS) mean difference|6.95||||0.0008|2-Sided|95.0|2.91|10.98||Between Treatment p-Values based on the statistical model adjusting for treatment, study period, and participant (random effect).|ANOVA||"LS Mean from Analysis of variance (ANOVA) with factors for treatment, study period, and participant (random effect).~Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment."||
1658963|NCT01563029|3053092|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1658964|NCT01563029|3053092|Superiority or Other||||||<|0.003|||||||Fisher Exact||||
1658965|NCT01563029|3053092|Superiority or Other||||||<|0.006|||||||Fisher Exact||||
1658966|NCT01563029|3053092|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1658967|NCT01563029|3053093|Superiority or Other||Mean Difference (Final Values)|3.0||||0.459|2-Sided|95.0|-5.0|11.1|||ANCOVA||||
1658968|NCT01563029|3053093|Superiority or Other||Mean Difference (Final Values)|3.9||||0.34|2-Sided|95.0|-4.1|12.0|||ANCOVA||||
1658969|NCT01563029|3053093|Superiority or Other||Mean Difference (Final Values)|5.8||||0.161||95.0|-2.3|13.9|||ANCOVA||||
1658970|NCT01563029|3053093|Superiority or Other||Mean Difference (Final Values)|2.1||||0.619|2-Sided|95.0|-6.1|10.2|||ANCOVA||||
1658971|NCT01563029|3053094|Superiority or Other||Mean Difference (Final Values)|16.7||||0.002|2-Sided|95.0|6.0|27.3|||ANCOVA||||
1658972|NCT01563029|3053094|Superiority or Other||Mean Difference (Final Values)|11.5||||0.033|2-Sided|95.0|0.9|22.1|||ANCOVA||||
1658973|NCT01563029|3053094|Superiority or Other||Mean Difference (Final Values)|17.9||||0.001|2-Sided|95.0|7.2|28.6|||ANCOVA||||
1658974|NCT01563029|3053094|Superiority or Other||Mean Difference (Final Values)|20.6|||<|0.001|2-Sided|95.0|10.0|31.3|||ANCOVA||||
1658975|NCT01563029|3053095|Superiority or Other||Mean Difference (Final Values)|6.2||||0.242|2-Sided|95.0|-4.2|16.6|||ANCOVA||||
1658976|NCT01563029|3053095|Superiority or Other||Mean Difference (Final Values)|5.9||||0.266|2-Sided|95.0|-4.5|16.3|||ANCOVA||||
1658977|NCT01563029|3053095|Superiority or Other||Mean Difference (Final Values)|13.1||||0.014|2-Sided|95.0|2.6|23.6|||ANCOVA||||
1658978|NCT01563029|3053095|Superiority or Other||Mean Difference (Final Values)|11.2||||0.037|2-Sided|95.0|0.7|21.7|||ANCOVA||||
1658979|NCT01563029|3053096|Superiority or Other||Mean Difference (Final Values)|8.0||||0.042|2-Sided|95.0|0.3|15.7|||ANCOVA||||
1658980|NCT01563029|3053096|Superiority or Other||Mean Difference (Final Values)|8.4|||<|0.033|2-Sided|95.0|0.7|16.1|||ANCOVA||||
1658981|NCT01563029|3053096|Superiority or Other||Mean Difference (Final Values)|13.4|||<|0.001|2-Sided|95.0|5.7|21.1|||ANCOVA||||
1658982|NCT01563029|3053096|Superiority or Other||Mean Difference (Final Values)|11.2|||<|0.005|2-Sided|95.0|3.4|19.0|||ANCOVA||||
1658983|NCT01563029|3053097|Superiority or Other||Mean Difference (Final Values)|6.2||||0.143|2-Sided|95.0|-2.1|14.6|||ANCOVA||||
1658984|NCT01563029|3053097|Superiority or Other||Mean Difference (Final Values)|12.2||||0.004|2-Sided|95.0|3.8|20.5|||ANCOVA||||
1658985|NCT01563029|3053097|Superiority or Other||Mean Difference (Final Values)|9.8||||0.023|2-Sided|95.0|1.3|18.2|||ANCOVA||||
1658986|NCT01563029|3053097|Superiority or Other||Mean Difference (Final Values)|8.4||||0.05|2-Sided|95.0|0.0|16.9|||ANCOVA||||
1658987|NCT01563029|3053098|Superiority or Other||Mean Difference (Final Values)|0.064||||0.089|2-Sided|95.0|-0.01|0.137|||ANCOVA||||
1658988|NCT01563029|3053098|Superiority or Other||Mean Difference (Final Values)|0.033||||0.379|2-Sided|95.0|-0.041|0.108|||ANCOVA||||
1658989|NCT01563029|3053098|Superiority or Other||Mean Difference (Final Values)|0.022||||0.551|2-Sided|95.0|-0.05|0.094|||ANCOVA||||
1658990|NCT01563029|3053098|Superiority or Other||Mean Difference (Final Values)|0.126|||<|0.001|2-Sided|95.0|0.051|0.201|||ANCOVA||||
1658991|NCT01563029|3053099|Superiority or Other||Median Difference (Final Values)|14.0|||<|0.001|2-Sided|95.0|6.7|21.4|||ANCOVA||||
1658992|NCT01563029|3053099|Superiority or Other||Mean Difference (Final Values)|18.6|||<|0.001|2-Sided|95.0|11.3|26.0|||ANCOVA||Inference for FF 25 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for both the FF 100 ug versus placebo comparison and the FF 50 ug versus placebocomparison.||
1658993|NCT01563029|3053099|Superiority or Other||Mean Difference (Final Values)|19.5|||<|0.001|2-Sided|95.0|12.1|26.9|||ANCOVA||Inference for FF 100 µg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparsion.||
1658994|NCT01563029|3053099|Superiority or Other||Mean Difference (Final Values)|12.5|||<|0.001|2-Sided|95.0|5.1|19.8|||ANCOVA||Inference for FF 100 μg versus (vs) placebo and FF 50 ug versus placebo was dependent upon statistical significance (SS) having first been achieved for the average of the higher two doses of FF (FF 100 ug and 50 ug ) versus placebo comparison.||
1658995|NCT01563029|3053099|Superiority or Other||Mean Difference (Final Values)|16.0|||<|0.001|2-Sided|95.0|9.6|22.4|||ANCOVA|Gate-keeper analysis|||
1658996|NCT01562782|3053109|Equivalence|A P value <0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided||||
1658997|NCT01562782|3053110|Equivalence|A P value <0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided||||
1658998|NCT01562782|3053111|Equivalence|A P value <0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided||||
1658999|NCT01562782|3053112|Equivalence|A P value <0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided||||
1659000|NCT01562782|3053113|Equivalence|A P value <0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||Pearson or Spearman's rank test|||The equivalence test was used to analyze the relationship between the primary outcome, fold change in VLDL TG palmitate, and the listed levels of biomarkers of carbohydrate and fat metabolism. The correlation analysis was performed on data from each study group separately.|
1659001|NCT01562782|3053114|Equivalence|A P value <0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided||||
1659002|NCT01562782|3053115|Equivalence|A P value <0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided||||
1659003|NCT01562782|3053116|Equivalence|A P value <0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||The equivalence test is used to compare levels after the sugar beverage of 1) glucose at 1 hour 2) lactate at 1 hour 3) NEFA at 2 hours in South Asians vs Caucasians.|
1659004|NCT01562782|3053117|Equivalence|A P value <0.05 was used to determine no equivalence between groups.|||||<|0.05|||||||t-test, 2 sided|||The equivalence test was used to compare 1) the fold change in triglycerides in South Asians and Caucasians and 2) the fold change in VLDL triglycerides in South Asians and Caucasians.|
1659005|NCT01562782|3053118|Equivalence|A P value <0.05 was used to determine no equivalence between groups in the primary outcome- the mean fold change in plasma VLDL triglyceride palmitate, 0-4 hours. A power calculation was based on data obtained in 15 overweight subjects. Assuming a mean absolute difference of 2.7 in South Asians and 1.0 in Caucasians and a standard deviation of 2.0 for both, group sample sizes of 16 and 16 were expected to achieve 80% power to detect a difference of 1.7 using a 2-sided Mann-Whitney test.|Mean Difference (Final Values)|0.61||||0.05|2-Sided||||||Mixed Models Analysis|||The equivalence test was used to compare the fold change in plasma VLDL triglyceride palmitate in Caucasians and South Asians.|
1659006|NCT01562548|3053142|Superiority or Other||Least Squares Means Difference|0.24||||0.58|2-Sided|95.0|-0.64|1.13||P-value associated with t-test for difference of LS means|t-test, 2 sided||Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was Second named treatment - first named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.|
1659007|NCT01562548|3053142|Superiority or Other||Least Squares Means Difference|0.35||||0.52|2-Sided|95.0|-0.72|1.42||P-value associated with t-test for difference of LS means|t-test, 2 sided||Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.|
1660347|NCT01552928|3054176|Superiority or Other||||||<|0.004|||||||ANCOVA||||
1659008|NCT01562548|3053142|Superiority or Other||Least Squares Means Difference|-0.21||||0.68|2-Sided|95.0|-1.23|0.8||P-value was associated with t-test for difference of LS means|t-test, 2 sided|The model included factors for treatment (as a fixed effect) and site (as a random effect).|Least Square mean from Mixed Model including factors for treatment (as a fixed effect) and site (as a random effect). Difference was First named treatment - second named treatment|Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.|
1659009|NCT01562314|3053274|Superiority or Other||Odds Ratio (OR)|1.3||||0.7032|2-Sided|90.0|0.419|4.04|||Regression, Logistic||||
1659010|NCT01562314|3053275|Superiority or Other||Odds Ratio (OR)|0.821||||0.7532|2-Sided|90.0|0.292|2.309|||Regression, Logistic||||
1659011|NCT01561976|3053316|Other||Ratio|107.38||||0.0169|2-Sided|95.0|98.3|117.29|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting||
1659012|NCT01561976|3053316|Other||Ratio|116.87||||0.0169|2-Sided|95.0|107.07|127.57|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting||
1659013|NCT01561976|3053317|Other||Ratio|107.24||||0.0171|2-Sided|95.0|98.35|116.94|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting||
1659014|NCT01561976|3053317|Other||Ratio|116.5||||0.0171|2-Sided|95.0|106.91|126.95|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting||
1659015|NCT01561976|3053318|Other||Ratio|107.24||||0.1413|2-Sided|95.0|99.37|115.73|||ANOVA||Ratio= METLEAD G2 Forte/METLEAD ForteSR-Fasting||
1659016|NCT01561976|3053318|Other||Ratio|108.94||||0.1413|2-Sided|95.0|101.01|117.5|||ANOVA||Ratio= METLEAD ForteSR-Fed/METLEAD ForteSR-Fasting||
1659017|NCT01561469|3053334|Superiority or Other|||||||0.512|||||||Wilcoxon (Mann-Whitney)||||
1659018|NCT01561469|3053335|Superiority or Other|||||||0.276|||||||Wilcoxon (Mann-Whitney)||||
1659019|NCT01561469|3053336|Superiority or Other|||||||0.823|||||||Wilcoxon (Mann-Whitney)||||
1659020|NCT01561469|3053337|Superiority or Other|||||||0.773|||||||Wilcoxon (Mann-Whitney)||||
1659021|NCT01561469|3053338|Superiority or Other|||||||0.759|||||||Chi-squared|||Analysis for colonization category reported.|
1659022|NCT01561469|3053338|Superiority or Other|||||||1|||||||Chi-squared|||Analysis for superinfections category reported.|
1659023|NCT01561469|3053339|Superiority or Other|||||||0.009|||||||Regression, Logistic||||
1659024|NCT01561300|3053355|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.66|2-Sided|95.0|-1.15|0.75||Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Mixed Models Analysis||Tea-placebo|Null hypothesis: no difference between Tea and Control.|
1659025|NCT01561300|3053356|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.7|2-Sided|95.0|-2.44|1.66|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Tea- Control|Null hypothesis: no difference between Tea and Control.|
1659026|NCT01561300|3053357|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.09|2-Sided|95.0|-2.16|0.17|||Mixed Models Analysis|Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effects.|Tea-placebo|Null hypothesis: no difference between Tea and Control.|
1659027|NCT01561079|3053358|Superiority or Other|||||||0.002|||||||Hierarchical Linear Modeling||||
1659028|NCT01561079|3053359|Superiority or Other|||||||0.008|||||||Hierarchical Linear Modeling|The reported p-value was calculated|||
1659029|NCT01561079|3053360|Superiority or Other|||||||0.0001|||||||Hierarchical Linear Modeling||||
1659030|NCT01561079|3053361|Superiority or Other||||||<|0.002|||||||Hierarchical Linear Modeling||||
1659031|NCT01561079|3053362|Superiority or Other|||||||0.001||||||The p values were not adjusted for multiplicity The a priori threshold = .05|Hierarchical Linear Modeling|The p-value was calculated|||
1659032|NCT01560819|3053393|Superiority or Other|||||||0.03|||||||Wilcoxon signed rank test|||A power calculation was not done for this pilot study. Changes in PUCAI post-treatment were compared with baseline using the Wilcoxon signed rank test. P value <0.05 was considered statistically significant.|
1659033|NCT01560780|3053394|Superiority|||||||0.97|||||||t-test, 2 sided||||
1659034|NCT01560780|3053396|Superiority|||||||0.97|||||||t-test, 2 sided||||
1659035|NCT01560780|3053397|Superiority|||||||0.85|||||||t-test, 2 sided||||
1659036|NCT01560780|3053398|Superiority|||||||0.19|||||||Fisher Exact||||
1659037|NCT01560780|3053399|Equivalence|safety end-point with p-value of <0.05|||||>|0.99|||||||Log Rank||||
1659038|NCT01560780|3053400|Superiority|||||||0.78|||||||Fisher Exact||||
1659039|NCT01560624|3053401|Superiority|||||||0.0028|||||||Fisher Exact||||
1659040|NCT01560624|3053402|Superiority||||||<|0.0001|||||||ANCOVA||||
1659041|NCT01560624|3053403|Superiority||Hodges Lehmann estimate location shift|7.0||||0.0913|2-Sided|95.0|0.0|16.0|||ANCOVA||||
1659042|NCT01560624|3053404|Superiority|||||||0.0391|||||||Log Rank||||
1659043|NCT01560624|3053404|Superiority||Hazard Ratio (HR)|0.74||||0.0275|2-Sided|95.0|0.56|0.97|||Cox proportion-hazard model||||
1659044|NCT01560416|3053413|Superiority|||||||0.68|||||||Fisher Exact||||
1659045|NCT01560416|3053415|Superiority|||||||0.79|||||||Log Rank||||
1659046|NCT01560234|3053442|Superiority or Other||Comparison of Placebo|1087.35|||||2-Sided|95.0|317.19|3727.57|||||Cohort 6 and 8/30 μg vs Placebo|24 hour Sputum|
1659047|NCT01560234|3053442|Superiority or Other||Comparison of Placebo|467.96|||||2-Sided|95.0|142.77|1533.92|||||Cohort 7/15 μg vs Placebo|24 hour Sputum|
1659048|NCT01560234|3053442|Superiority or Other||Comparison of Placebo|193.8|||||2-Sided|95.0|59.01|636.49|||||Cohort 5/15 μg vs Placebo|24 hour Sputum|
1659049|NCT01560234|3053442|Superiority or Other||Comparison of Placebo|304.37|||||2-Sided|95.0|76.61|1209.33|||||Cohort 4/5 ug vs Placebo|24 hour Sputum|
1659050|NCT01560234|3053442|Superiority or Other||Comparison of Placebo|81.55|||||2-Sided|95.0|20.63|322.42|||||Cohort 3/1.5 ug vs Placebo|24 hour Sputum|
1659051|NCT01560234|3053442|Superiority or Other||Comparison of Placebo|81.89|||||2-Sided|95.0|24.96|268.7|||||Cohort 2/0.5 ug vs Placebo|24 hour Sputum|
1659052|NCT01560234|3053442|Superiority or Other||Comparison of Placebo|114.87|||||2-Sided|95.0|34.83|378.78|||||Cohort 1/0.15 ug vs Placebo|24 hour Sputum|
1659053|NCT01560234|3053444|Superiority or Other||Percentage of Placebo|240.04|||||2-Sided|95.0|193.82|297.28|||||Cohort 6 and 8/30 ug|48 hour plasma|
1659054|NCT01560234|3053444|Superiority or Other||Percentage of Placebo|146.86|||||2-Sided|95.0|111.39|193.62|||||Cohort 7/15 ug vs Placebo|48 hour plasma|
1659055|NCT01560234|3053444|Superiority or Other||Percentage of Placebo|102.67|||||2-Sided|95.0|77.02|136.87|||||Cohort 5/15 ug vs Placebo|48 hour placebo|
1659056|NCT01560234|3053444|Superiority or Other||Percentage of Placebo|120.0|||||2-Sided|95.0|91.04|158.18|||||Cohort 4/5 ug vs Placebo|48 hour plasma|
1659057|NCT01560234|3053444|Superiority or Other||Percentage of Placebo|112.34|||||2-Sided|95.0|82.3|153.35|||||Cohort 3/1.5 ug vs Placebo|48 hour Plasma|
1659058|NCT01560234|3053444|Superiority or Other||Percentage of Placebo|91.72|||||2-Sided|95.0|69.53|121.0|||||Cohort 2/0.5 ug vs Placebo|48 hour plasma|
1659059|NCT01560234|3053444|Superiority or Other||Percentage of Placebo|95.81|||||2-Sided|95.0|72.7|126.28|||||Cohort 1/0.15 ug vs Placebo|48 hour plasma|
1659060|NCT01560234|3053445|Superiority or Other||Percentage of Placebo|684.03|||||2-Sided|95.0|495.31|944.65|||||Cohort 6 and 8/30 μg vs Placebo|24 hour plasma|
1659061|NCT01560234|3053445|Superiority or Other||Percentage of Placebo|228.23|||||2-Sided|95.0|150.36|346.41|||||Cohort 7/15 μg vs Placebo|24 hour plasma|
1659062|NCT01560234|3053445|Superiority or Other||Percentage of Placebo|223.76||||||95.0|144.98|345.35|||||Cohort 5/15 μg vs Placebo|24 hour plasma|
1659063|NCT01560234|3053445|Superiority or Other||Percentage of Placebo|106.23|||||2-Sided|95.0|66.42|169.93|||||Cohort 3/1.5 ug vs Placebo|24 hour Plasma|
1659064|NCT01560234|3053445|Superiority or Other||Percentage of Placebo|145.83|||||2-Sided|95.0|96.11|221.28|||||Cohort 4/5 ug vs Placebo|24 hour Plasma|
1659065|NCT01560234|3053445|Superiority or Other||Percentage of Placebo|92.99|||||2-Sided|95.0|61.21|141.27|||||Cohort 2/1.5ug vs Placebo|24 hour Plasma|
1659066|NCT01560234|3053445|Superiority or Other||Percentage of Placebo|99.75|||||2-Sided|95.0|65.76|151.32|||||Cohort 1/0.15 ug vs Placebo|24 hour Plasma|
1659067|NCT01560234|3053446|Superiority or Other||Slope|0.95|Standard Error of the Mean|0.05|||2-Sided|90.0|0.87|1.04|||||Cmax (nmol/L) 0.5 to 30 μg||
1659068|NCT01560234|3053447|Superiority or Other||Slope|0.84|Standard Error of the Mean|0.11|||2-Sided|90.0|0.65|1.04|||||AUC(0-t) (nmol*h/L) 5 to 30 μg||
1659069|NCT01560234|3053448|Superiority or Other||Slope|0.81|Standard Error of the Mean|0.1|||2-Sided|90.0|0.63|1.0|||||AUC (nmol*h/L) 5 to 30 μg||
1659070|NCT01559454|3053480|Superiority or Other||Odds Ratio (OR)|0.6||||0.6999|2-Sided|95.0|0.127|2.8352|||Fisher Exact||||
1659071|NCT01559454|3053481|Superiority or Other||Mean Difference (Final Values)|12.1499||||0.895|2-Sided|95.0|-30.3965|27.0632|||t-test, 2 sided||||
1659072|NCT01559454|3053482|Superiority or Other||Median Difference (Final Values)|39.5833||||0.088|2-Sided|95.0|-7.9653|87.132|||t-test, 2 sided||||
1659073|NCT01559454|3053483|Superiority or Other||Mean Difference (Final Values)|15.55075||||0.348|2-Sided|95.0|-20.37051|51.34968|||t-test, 2 sided||||
1659074|NCT01559454|3053484|Superiority or Other||Odds Ratio (OR)|1.5||||1|2-Sided|95.0|0.0713|1.8248|||Fisher Exact||||
1659075|NCT01559454|3053485|Superiority or Other||Mean Difference (Final Values)|35.4167||||0.097|2-Sided|95.0|-8.7519|79.5852|||t-test, 2 sided||||
1659076|NCT01559389|3053486|Superiority||z-score|0.89||||0.37|2-Sided||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between the two groups|The null hypothesis is that there is no difference in the overall GRISS change score between male partners of female participants who respond to solifenacin and male partners of female participants who do not respond to solifenacin|
1659077|NCT01559389|3053487|Superiority||z-score|2.97||||0.003|2-Sided||||||Wilcoxon (Mann-Whitney)|Exact test|The z-score is a standardized Wilcoxon statistic. In this study, z-scores with an absolute value exceeding 1.96 indicate a significant difference in the GRISS change score between responders and non-responders of solifenacin treatment|The null hypothesis is that there is no difference in the overall GRISS change score between those who respond and do not respond to treatment with solifenacin.|
1659078|NCT01559389|3053488|Superiority||Mean Difference (Final Values)|-0.51|Standard Deviation|2.5||0.16|2-Sided|95.0|-1.23|0.21||P-values less than 0.05 were considered statistically significant.|t-test, 2 sided|The method was a paired t-test||The null hypothesis is that there is no difference in the overall GRISS score between females with UUI and their male partners|
1659079|NCT01559311|3053489|Superiority or Other|||||||0.5871|||||||Wilcoxon (Mann-Whitney)|||"H04: μ LVESV, 1 = μ LVESV, 2b vs H1b: μ LVESV, 1 > μ LVESV, 2b~Where, μLVESV, 1 is the mean of LVESV at month 12 in the DDDR Group,~and μLVESV, 2b is the mean of LVESV at month 12 in CRT-P OFF group."|
1659080|NCT01559311|3053489|Superiority or Other|||||||0.6276|||||||Wilcoxon (Mann-Whitney)|||"H02: μ LVESV, 1 = μ LVESV, 2a vs H1b: μ LVESV, 1 > μ LVESV, 2a~Where, μLVESV, 1 is the mean of LVESV at month 12 in the DDDR Group,~μLVESV, 2a is the mean of LVESV at month 12 in the CRT-P ON group"|
1659081|NCT01559311|3053490|Superiority or Other|||||||0.1439|||||||Wilcoxon (Mann-Whitney)|||"H03: μ LVEF, 1= μ LVEF, 2b vs H1a: μ LVEF, 1 < μ LVEF, 2b~Where μ LVEF, 1 is the mean of LVEF at month 12 in DDDR Gp.~μ LVEF, 2b is the mean of LVEF at month 12 in the CRT-P OFF Gp"|
1659082|NCT01559311|3053490|Superiority or Other|||||||0.1734|||||||Wilcoxon (Mann-Whitney)|||"H01: μ LVEF, 1= μ LVEF, 2a vs H1a: μ LVEF, 1 < μ LVEF, 2a~Where μ LVEF, 1 is the mean of LVEF at month 12 in DDDR Gp.~μ LVEF, 2a is the mean of LVEF at month 12 in CRT-P ON Gp,"|
1659083|NCT01559259|3053491|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.1||||0.365|2-Sided|95.0|-0.32|0.11||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.|
1660038|NCT01558271|3053629|Superiority or Other||LS Mean Difference|0.57||||0.835|2-Sided|95.0|-4.82|5.96|||Mixed Models Analysis|Treatment comparison for FBG at 26 weeks between LY2189265 and Liraglutide.|||
1659084|NCT01559259|3053491|Superiority or Other (legacy)||Mean Difference (Final Values)|0.04||||0.722|2-Sided|95.0|-0.18|0.26||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.|
1659085|NCT01559259|3053491|Superiority or Other (legacy)||Mean Difference (Final Values)|0.15||||0.174|2-Sided|95.0|-0.07|0.37||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.|
1659086|NCT01559259|3053491|Superiority or Other (legacy)||Mean Difference (Final Values)|0.8|||<|0.001|2-Sided|95.0|0.65|0.95||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.|
1659087|NCT01559259|3053491|Superiority or Other (legacy)||Mean Difference (Final Values)|0.86|||<|0.001|2-Sided|95.0|0.73|0.99||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.|
1659088|NCT01559259|3053491|Superiority or Other (legacy)||Mean Difference (Final Values)|0.83|||<|0.001|2-Sided|95.0|0.79|1.01||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.|
1659089|NCT01559259|3053491|Superiority or Other (legacy)||Mean Difference (Final Values)|0.9|||<|0.001|2-Sided|95.0|0.79|1.01||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference and its associated 95% CI were calculated based on the weighted Gamma statistic.|
1659090|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-4.41||||0.542|2-Sided|95.0|-18.61|9.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659091|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|1.48||||0.835|2-Sided|95.0|-12.54|15.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659092|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|9.16||||0.195|2-Sided|95.0|-4.75|23.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659093|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-25.04||||0.012|2-Sided|95.0|-42.23|-7.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659094|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-28.44||||0.006|2-Sided|95.0|-45.99|-10.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659095|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-23.71||||0.019|2-Sided|95.0|-40.91|-6.51||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659096|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-15.81||||0.107|2-Sided|95.0|-33.02|1.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659097|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-4.53||||0.536|2-Sided|95.0|-18.86|9.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659098|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|0.55||||0.939|2-Sided|95.0|-13.63|14.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659497|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.54||||0.081|2-Sided|95.0|-1.15|0.07|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659099|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|4.66||||0.516|2-Sided|95.0|-9.5|18.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659100|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-27.26||||0.007|2-Sided|95.0|-44.51|-10.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659101|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-30.76||||0.003|2-Sided|95.0|-48.36|-13.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659102|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-26.87||||0.009|2-Sided|95.0|-44.12|-9.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659103|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-22.63||||0.024|2-Sided|95.0|-39.97|-5.29||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659104|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-2.48||||0.731|2-Sided|95.0|-16.63|11.66||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659105|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|0.43||||0.953|2-Sided|95.0|-13.8|14.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659106|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|5.45||||0.455|2-Sided|95.0|-8.89|19.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659107|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-34.56|||<|0.001|2-Sided|95.0|-51.77|-17.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659108|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-36.26|||<|0.001|2-Sided|95.0|-53.8|-18.73||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659109|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-34.3|||<|0.001|2-Sided|95.0|-51.62|-16.97||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659110|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-29.13|||<|0.005|2-Sided|95.0|-46.66|-11.59||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659111|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|0.44|||<|0.951|2-Sided|95.0|-13.47|14.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659112|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-2.51|||<|0.721|2-Sided|95.0|-16.2|11.18||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659113|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|4.29|||<|0.548|2-Sided|95.0|-9.8|18.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659114|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-44.45|||<|0.001|2-Sided|95.0|-61.55|-27.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659115|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-43.15|||<|0.001|2-Sided|95.0|-60.57|-25.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659116|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-47.24|||<|0.001|2-Sided|95.0|-64.21|-30.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659117|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-40.27|||<|0.001|2-Sided|95.0|-57.67|-22.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659118|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-6.43|||<|0.34|2-Sided|95.0|-19.56|6.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659119|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-8.78|||<|0.184|2-Sided|95.0|-21.5|3.94||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659120|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-3.52|||<|0.604|2-Sided|95.0|-16.89|9.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659121|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-47.82|||<|0.001|2-Sided|95.0|-64.81|-30.83||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659122|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-53.21|||<|0.001|2-Sided|95.0|-70.16|-36.26||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659123|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-57.01|||<|0.001|2-Sided|95.0|-73.27|-40.76||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659124|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-51.54|||<|0.001|2-Sided|95.0|-68.42|-34.66||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659125|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-11.23|||<|0.067|2-Sided|95.0|-22.97|0.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659126|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-6.34|||<|0.311|2-Sided|95.0|-18.39|5.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659127|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-9.14|||<|0.137|2-Sided|95.0|-21.18|2.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659128|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-53.41|||<|0.001|2-Sided|95.0|-70.1|-36.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659129|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-63.45|||<|0.001|2-Sided|95.0|-79.64|-47.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659130|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-60.09|||<|0.001|2-Sided|95.0|-76.15|-44.02||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659131|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-62.49|||<|0.001|2-Sided|95.0|-78.64|-46.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659132|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-5.88|||<|0.303|2-Sided|95.0|-16.88|5.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659133|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-1.88|||<|0.747|2-Sided|95.0|-13.15|9.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659134|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-11.49|||<|0.028|2-Sided|95.0|-21.63|-1.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659135|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-59.84|||<|0.001|2-Sided|95.0|-76.12|-43.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659136|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-64.57|||<|0.001|2-Sided|95.0|-80.64|-48.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659137|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-62.11|||<|0.001|2-Sided|95.0|-78.04|-46.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659138|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-71.36|||<|0.001|2-Sided|95.0|-86.58|-56.13||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659139|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-5.09|||<|0.308|2-Sided|95.0|-14.8|4.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659140|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-0.69|||<|0.895|2-Sided|95.0|-10.69|9.32||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659141|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-10.61|||<|0.016|2-Sided|95.0|-19.02|-2.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659142|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-65.19|||<|0.001|2-Sided|95.0|-81.03|-49.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659143|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-69.33|||<|0.001|2-Sided|95.0|-84.96|-53.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659144|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-66.43|||<|0.001|2-Sided|95.0|-81.99|-50.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659145|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-75.64|||<|0.001|2-Sided|95.0|-90.35|-60.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659146|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-7.36|||<|0.126|2-Sided|95.0|-16.63|1.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659147|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-4.94|||<|0.31|2-Sided|95.0|-14.34|4.46||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659148|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-11.7|||<|0.007|2-Sided|95.0|-19.86|-3.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659149|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-65.19|||<|0.001|2-Sided|95.0|-81.03|-49.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659150|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-71.66|||<|0.001|2-Sided|95.0|-87.0|-56.31||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659151|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-70.6|||<|0.001|2-Sided|95.0|-85.79|-55.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659152|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-76.81|||<|0.001|2-Sided|95.0|-91.35|-62.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659153|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-6.29|||<|0.162|2-Sided|95.0|-14.97|2.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659154|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-3.99|||<|0.385|2-Sided|95.0|-12.86|4.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659155|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-10.71|||<|0.007|2-Sided|95.0|-18.2|-3.21||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659156|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-67.2|||<|0.001|2-Sided|95.0|-82.87|-51.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659157|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-72.87|||<|0.001|2-Sided|95.0|-88.06|-57.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659158|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-71.65|||<|0.001|2-Sided|95.0|-86.71|-56.58||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659159|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-77.89|||<|0.001|2-Sided|95.0|-92.29|-63.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659160|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-5.26|||<|0.204|2-Sided|95.0|-13.28|2.76||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659161|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-3.99|||<|0.337|2-Sided|95.0|-12.05|4.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659162|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-8.53|||<|0.021|2-Sided|95.0|-15.55|-1.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659163|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-62.76|||<|0.001|2-Sided|95.0|-80.45|-45.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659164|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-67.47|||<|0.001|2-Sided|95.0|-84.75|-50.19||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659165|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-66.99|||<|0.001|2-Sided|95.0|-84.26|-49.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659166|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-71.19|||<|0.001|2-Sided|95.0|-88.0|-54.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659167|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-0.96|||<|0.769|2-Sided|95.0|-7.41|5.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659168|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-2.89|||<|0.304|2-Sided|95.0|-8.4|2.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659169|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-3.13|||<|0.274|2-Sided|95.0|-8.67|2.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659170|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-38.11|||<|0.001|2-Sided|95.0|-56.94|-19.28||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659171|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-38.64|||<|0.001|2-Sided|95.0|-57.49|-19.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659172|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-40.98|||<|0.001|2-Sided|95.0|-59.41|-22.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659173|NCT01559259|3053492|Superiority or Other (legacy)||Difference in proportion|-41.07|||<|0.001|2-Sided|95.0|-59.56|-22.58||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659174|NCT01559259|3053493|Superiority or Other (legacy)||LS mean difference|0.86||||0.454|2-Sided|95.0|0.57|1.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.|
1659175|NCT01559259|3053493|Superiority or Other (legacy)||LS mean difference|0.97||||0.863|2-Sided|95.0|0.66|1.42||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.|
1659176|NCT01559259|3053493|Superiority or Other (legacy)||LS mean difference|1.12||||0.549|2-Sided|95.0|0.77|1.63||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.|
1659177|NCT01559259|3053493|Superiority or Other (legacy)||LS mean difference|0.25|||<|0.001|2-Sided|95.0|0.15|0.41||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 400 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.|
1659178|NCT01559259|3053493|Superiority or Other (legacy)||LS mean difference|0.21|||<|0.001|2-Sided|95.0|0.13|0.35||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.|
1659179|NCT01559259|3053493|Superiority or Other (legacy)||LS mean difference|0.24|||<|0.001|2-Sided|95.0|0.15|0.39||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.|
1659180|NCT01559259|3053493|Superiority or Other (legacy)||Hazard Ratio (HR)|0.28|||<|0.001|2-Sided|95.0|0.17|0.45||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo), p-value, HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical pain severity rating and gender terms used as covariates.|
1659181|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|3.99||||0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659182|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|1.85||||0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659183|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|5.25||||0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659184|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659185|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659186|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659187|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659188|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659189|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659190|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659191|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659192|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659193|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659194|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659195|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659196|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659197|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659198|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659199|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659200|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659201|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659202|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659203|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659204|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659205|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659206|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659207|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659208|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659209|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659210|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659211|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659212|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659213|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659214|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659215|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659216|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659217|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659218|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659219|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659220|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659221|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659222|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659223|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659224|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659225|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659226|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659227|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659228|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659229|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659230|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659231|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659232|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659233|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659234|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659235|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659236|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659237|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659238|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659239|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659240|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659241|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659242|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659243|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659244|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659245|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659246|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659247|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659248|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659249|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659250|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659251|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659252|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659253|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659254|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659255|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659256|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659257|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659258|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|5.05|||<|0.311|2-Sided|95.0|-4.6|14.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659259|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|0.79|||<|0.881|2-Sided|95.0|-9.42|10.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659260|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|6.33|||<|0.187|2-Sided|95.0|-2.99|15.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659261|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|68.36|||<|0.001|2-Sided|95.0|54.01|82.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659262|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|73.52|||<|0.001|2-Sided|95.0|59.65|87.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659263|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|69.38|||<|0.001|2-Sided|95.0|55.05|83.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659264|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|74.49|||<|0.001|2-Sided|95.0|60.73|88.25||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659265|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|8.34|||<|0.125|2-Sided|95.0|-2.2|18.87||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659266|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|2.84|||<|0.616|2-Sided|95.0|-8.3|13.98||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659267|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|8.4|||<|0.119|2-Sided|95.0|-2.06|18.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659268|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|64.12|||<|0.001|2-Sided|95.0|49.32|78.91||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659269|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|72.4|||<|0.001|2-Sided|95.0|58.4|86.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659270|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|67.2|||<|0.001|2-Sided|95.0|52.63|81.78||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659271|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|72.32|||<|0.001|2-Sided|95.0|58.25|86.39||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659272|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|14.58|||<|0.034|2-Sided|95.0|1.22|27.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659273|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|2.98|||<|0.674|2-Sided|95.0|-10.94|16.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659274|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|10.28|||<|0.14|2-Sided|95.0|-3.26|23.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659275|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|53.31|||<|0.001|2-Sided|95.0|38.62|67.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659276|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|67.57|||<|0.001|2-Sided|95.0|53.58|81.55||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659277|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|56.81|||<|0.001|2-Sided|95.0|42.28|71.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659278|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|63.3|||<|0.001|2-Sided|95.0|49.07|77.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659279|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|8.58|||<|0.176|2-Sided|95.0|-3.88|21.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659280|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|-1.95|||<|0.735|2-Sided|95.0|-13.34|9.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659281|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|6.86|||<|0.269|2-Sided|95.0|-4.8|18.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659282|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|16.57|||<|0.03|2-Sided|95.0|6.25|26.88||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659283|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|24.98|||<|0.005|2-Sided|95.0|13.43|36.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659284|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|14.83|||<|0.048|2-Sided|95.0|4.59|25.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659285|NCT01559259|3053494|Superiority or Other (legacy)||Difference in proportion|23.99|||<|0.003|2-Sided|95.0|13.32|34.67||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659286|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|3.99||||0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659287|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|1.85||||0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659288|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|5.25||||0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659289|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659290|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659291|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659292|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659293|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659294|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659295|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659296|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659297|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659298|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659299|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||11 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659300|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659301|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659302|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659303|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|65.95|||<|0.001|2-Sided|95.0|50.16|81.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659304|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|69.98|||<|0.001|2-Sided|95.0|54.47|85.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659305|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|68.31|||<|0.001|2-Sided|95.0|52.88|83.74||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659306|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|71.1|||<|0.001|2-Sided|95.0|55.82|86.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||10 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659307|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659308|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659309|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659310|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|69.21|||<|0.001|2-Sided|95.0|53.86|84.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659311|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|73.24|||<|0.001|2-Sided|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659312|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|71.59|||<|0.001|2-Sided|95.0|56.61|86.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659313|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|74.38|||<|0.001|2-Sided|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||9 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659314|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|3.99|||<|0.416|2-Sided|95.0|-5.52|13.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659315|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|1.85|||<|0.71|2-Sided|95.0|-7.82|11.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659316|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|5.25|||<|0.265|2-Sided|95.0|-3.92|14.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659317|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|69.21|||<|0.001|2-Sided|95.0|53.86|84.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659318|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|73.24|||<|0.001|2-Sided|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659319|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|71.59|||<|0.001|2-Sided|95.0|56.61|86.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659320|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|74.38|||<|0.001|2-Sided|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659321|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|5.06|||<|0.312|2-Sided|95.0|-4.68|14.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659322|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|1.97|||<|0.703|2-Sided|95.0|-8.18|12.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659323|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|6.38|||<|0.186|2-Sided|95.0|-3.05|15.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659324|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|68.05|||<|0.001|2-Sided|95.0|52.53|83.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659325|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|73.24|||<|0.001|2-Sided|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659326|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|70.54|||<|0.001|2-Sided|95.0|55.45|85.64||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659327|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|74.38|||<|0.001|2-Sided|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659328|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|6.12|||<|0.229|2-Sided|95.0|-3.76|16.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659329|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|1.97|||<|0.712|2-Sided|95.0|-8.5|12.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659330|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|7.46|||<|0.129|2-Sided|95.0|-2.12|17.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659331|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|67.0|||<|0.001|2-Sided|95.0|51.4|82.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659332|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|73.24|||<|0.001|2-Sided|95.0|58.18|88.3||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659333|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|69.5|||<|0.001|2-Sided|95.0|54.29|84.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659334|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|74.38|||<|0.001|2-Sided|95.0|59.56|89.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659335|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|7.21|||<|0.164|2-Sided|95.0|-2.8|17.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659336|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|2.01|||<|0.714|2-Sided|95.0|-8.76|12.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659337|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|8.56|||<|0.086|2-Sided|95.0|-1.15|18.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659338|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|69.1|||<|0.001|2-Sided|95.0|54.14|84.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659339|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|76.5|||<|0.001|2-Sided|95.0|62.22|90.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659340|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|71.65|||<|0.001|2-Sided|95.0|57.07|86.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659341|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|77.66|||<|0.001|2-Sided|95.0|63.63|91.69||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659342|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|8.28|||<|0.115|2-Sided|95.0|-1.85|18.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659343|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|2.01|||<|0.721|2-Sided|95.0|-9.02|13.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659344|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|8.57|||<|0.098|2-Sided|95.0|-1.47|18.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659345|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|68.05|||<|0.001|2-Sided|95.0|53.02|83.09||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659346|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|76.5|||<|0.001|2-Sided|95.0|62.22|90.79||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659347|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|70.6|||<|0.001|2-Sided|95.0|55.93|85.28||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659348|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|76.55|||<|0.001|2-Sided|95.0|62.37|90.72||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659349|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|8.27|||<|0.127|2-Sided|95.0|-2.23|18.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659350|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|0.65|||<|0.911|2-Sided|95.0|-10.73|12.03||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659351|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|9.61|||<|0.069|2-Sided|95.0|-0.59|19.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659352|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|70.56|||<|0.001|2-Sided|95.0|57.04|84.07||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659353|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|78.92|||<|0.001|2-Sided|95.0|66.29|91.56||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659354|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|71.65|||<|0.001|2-Sided|95.0|58.25|85.05||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659355|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|79.93|||<|0.001|2-Sided|95.0|67.41|92.46||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659356|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|10.28|||<|0.09|2-Sided|95.0|-1.47|22.03||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659357|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|2.84|||<|0.652|2-Sided|95.0|-9.49|15.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659358|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|11.59|||<|0.052|2-Sided|95.0|0.12|23.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659359|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|64.23|||<|0.001|2-Sided|95.0|50.3|78.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659360|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|74.46|||<|0.001|2-Sided|95.0|61.21|87.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659361|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|67.45|||<|0.001|2-Sided|95.0|53.65|81.24||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659362|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|75.6|||<|0.001|2-Sided|95.0|62.5|88.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659363|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|11.33|||<|0.087|2-Sided|95.0|-1.55|24.21||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659364|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|2.35|||<|0.729|2-Sided|95.0|-10.91|15.61||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659365|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|14.43|||<|0.027|2-Sided|95.0|1.97|26.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659366|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|60.5|||<|0.001|2-Sided|95.0|47.89|73.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659367|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|71.39|||<|0.001|2-Sided|95.0|59.21|83.57||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659368|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|63.18|||<|0.001|2-Sided|95.0|50.42|75.95||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659369|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|74.68|||<|0.001|2-Sided|95.0|62.82|86.53||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659370|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|13.3|||<|0.063|2-Sided|95.0|-0.57|27.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659371|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|-0.59|||<|0.935|2-Sided|95.0|-14.71|13.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659372|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|10.66|||<|0.138|2-Sided|95.0|-3.04|24.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659373|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|52.03|||<|0.001|2-Sided|95.0|40.43|63.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659374|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|64.68|||<|0.001|2-Sided|95.0|52.92|76.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659375|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|51.66|||<|0.001|2-Sided|95.0|39.5|63.82||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659376|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|62.54|||<|0.001|2-Sided|95.0|50.93|74.15||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||1 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659377|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|9.36|||<|0.1|2-Sided|95.0|-1.73|20.45||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659378|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|9.56|||<|0.088|2-Sided|95.0|-1.39|20.51||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659379|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|20.14|||<|0.001|2-Sided|95.0|8.67|31.62||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659380|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|13.39|||<|0.035|2-Sided|95.0|6.28|20.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659381|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|22.28|||<|0.005|2-Sided|95.0|13.55|31.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659382|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|23.34|||<|0.003|2-Sided|95.0|14.93|31.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659383|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|33.67|||<|0.001|2-Sided|95.0|24.54|42.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659384|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|2.33|||<|0.28|2-Sided|95.0|-1.98|6.64||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659385|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|-0.23|||<|0.879|2-Sided|95.0|-3.26|2.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659386|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|-0.01|||<|0.994|2-Sided|95.0|-3.13|3.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659387|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|1.16|||<|0.552|2-Sided|95.0|-1.11|3.42||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659388|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|3.65|||<|0.282|2-Sided|95.0|-0.39|7.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659389|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|0.98|||<|0.593|2-Sided|95.0|-0.94|2.9||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1659390|NCT01559259|3053495|Superiority or Other (legacy)||Difference in proportion|1.08|||<|0.571|2-Sided|95.0|-1.04|3.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level.|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.|
1659391|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|2.46||||0.432|2-Sided|95.0|-3.69|8.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659392|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|-2.4||||0.44|2-Sided|95.0|-8.51|3.71||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659393|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|-0.71||||0.821|2-Sided|95.0|-6.86|5.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659394|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|30.64|||<|0.001|2-Sided|95.0|21.87|39.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659395|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|33.1|||<|0.001|2-Sided|95.0|24.31|41.89||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659396|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|28.24|||<|0.001|2-Sided|95.0|19.48|37.0||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659498|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.66||||0.036|2-Sided|95.0|-1.27|-0.04|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660348|NCT01552915|3054180|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1659397|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|29.93|||<|0.001|2-Sided|95.0|21.14|38.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659398|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|2.56|||<|0.099|2-Sided|95.0|-0.48|5.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659399|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|-0.07|||<|0.965|2-Sided|95.0|-3.09|2.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659400|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|1.83|||<|0.237|2-Sided|95.0|-1.21|4.88||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659401|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|19.69|||<|0.001|2-Sided|95.0|15.35|24.02||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659402|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|22.24|||<|0.001|2-Sided|95.0|17.89|26.59||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659403|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|19.62|||<|0.001|2-Sided|95.0|15.29|23.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659404|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|21.52|||<|0.001|2-Sided|95.0|17.17|25.87||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659405|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|1.15|||<|0.01|2-Sided|95.0|0.28|2.03||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659406|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|0.39|||<|0.38|2-Sided|95.0|-0.48|1.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659407|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|1.03|||<|0.022|2-Sided|95.0|0.15|1.9||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659408|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|5.48|||<|0.001|2-Sided|95.0|4.23|6.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659409|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|6.63|||<|0.001|2-Sided|95.0|5.38|7.88||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659410|NCT01559259|3053496|Superiority or Other (legacy)||LS Mean difference|5.87|||<|0.001|2-Sided|95.0|4.62|7.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659499|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|1.08||||0.016|2-Sided|95.0|0.21|1.96|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660349|NCT01552915|3054180|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1659411|NCT01559259|3053496|Superiority or Other (legacy)||LS mean difference|6.5|||<|0.001|2-Sided|95.0|5.25|7.76||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659412|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|1.53||||0.42|2-Sided|95.0|-2.19|5.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659413|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|-1.62||||0.39|2-Sided|95.0|-5.32|2.08||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659414|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|-0.64||||0.736|2-Sided|95.0|-4.37|3.09||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659415|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|18.92|||<|0.001|2-Sided|95.0|13.61|24.24||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659416|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|20.45|||<|0.001|2-Sided|95.0|15.13|25.78||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659417|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|17.3|||<|0.001|2-Sided|95.0|11.99|22.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659418|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|18.28|||<|0.001|2-Sided|95.0|12.95|23.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659419|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|1.53|||<|0.227|2-Sided|95.0|-0.96|4.02||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659420|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|-0.35|||<|0.783|2-Sided|95.0|-2.82|2.13||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659421|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|0.83|||<|0.514|2-Sided|95.0|-1.66|3.32||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659422|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|15.23|||<|0.001|2-Sided|95.0|11.68|18.78||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659423|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|16.76|||<|0.001|2-Sided|95.0|13.2|20.32||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659424|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|14.88|||<|0.001|2-Sided|95.0|11.33|18.43||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659500|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.9||||0.045|2-Sided|95.0|0.02|1.78|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660350|NCT01552915|3054180|Superiority or Other||||||<|0.6165|||||||Cochran-Mantel-Haenszel||||
1659425|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|16.05|||<|0.001|2-Sided|95.0|12.49|19.61||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659426|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|1.5|||<|0.105|2-Sided|95.0|-0.32|3.31||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659427|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|-0.1|||<|0.91|2-Sided|95.0|-1.91|1.7||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659428|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|1.1|||<|0.235|2-Sided|95.0|-0.72|2.91||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659429|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|12.04|||<|0.001|2-Sided|95.0|9.45|14.63||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659430|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|13.54|||<|0.001|2-Sided|95.0|10.95|16.13||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659431|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|11.94|||<|0.001|2-Sided|95.0|9.35|14.52||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659432|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|13.14|||<|0.001|2-Sided|95.0|10.54|15.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659433|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|0.68|||<|0.011|2-Sided|95.0|0.15|1.21||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659434|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|0.24|||<|0.36|2-Sided|95.0|-0.28|0.77||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659435|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|0.58|||<|0.031|2-Sided|95.0|0.05|1.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659436|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|3.39|||<|0.001|2-Sided|95.0|2.64|4.14||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659437|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|4.07|||<|0.001|2-Sided|95.0|3.32|4.83||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659438|NCT01559259|3053497|Superiority or Other (legacy)||LS Mean difference|3.64|||<|0.001|2-Sided|95.0|2.88|4.39||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659439|NCT01559259|3053497|Superiority or Other (legacy)||LS mean difference|3.97|||<|0.001|2-Sided|95.0|3.22|4.73||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659440|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|0.87||||0.841|2-Sided|95.0|-7.66|9.39||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659441|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|-2.04||||0.629|2-Sided|95.0|-10.36|6.27||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659442|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|-1.29||||0.767|2-Sided|95.0|-9.82|7.25||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659443|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|44.25|||<|0.001|2-Sided|95.0|31.79|56.71||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659444|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|45.12|||<|0.001|2-Sided|95.0|32.67|57.57||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659445|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|42.2|||<|0.001|2-Sided|95.0|29.9|54.51||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659446|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|42.96|||<|0.001|2-Sided|95.0|30.51|55.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659447|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|1.92|||<|0.517|2-Sided|95.0|-3.9|7.74||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659448|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|-0.07|||<|0.979|2-Sided|95.0|-5.75|5.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659449|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|1.8|||<|0.543|2-Sided|95.0|-4.02|7.63||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659450|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|35.17|||<|0.001|2-Sided|95.0|26.67|43.68||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659451|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|37.09|||<|0.001|2-Sided|95.0|28.6|45.59||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659452|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|35.1|||<|0.001|2-Sided|95.0|26.7|43.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659453|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|36.98|||<|0.001|2-Sided|95.0|28.48|45.47||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1660562|NCT01549652|3054528|Superiority or Other|||||||0.92|||||||t-test, 2 sided||||
1659454|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|2.27|||<|0.299|2-Sided|95.0|-2.02|6.55||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659455|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|0.33|||<|0.875|2-Sided|95.0|-3.84|4.51||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659456|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|2.63|||<|0.228|2-Sided|95.0|-1.65|6.92||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659457|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|27.59|||<|0.001|2-Sided|95.0|21.33|33.86||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659458|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|29.86|||<|0.001|2-Sided|95.0|23.6|36.12||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659459|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|27.93|||<|0.001|2-Sided|95.0|21.74|34.11||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659460|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|30.23|||<|0.001|2-Sided|95.0|23.97|36.48||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659461|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|1.05|||<|0.101|2-Sided|95.0|-0.21|2.3||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659462|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|0.53|||<|0.392|2-Sided|95.0|-0.69|1.76||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659463|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|1.45|||<|0.024|2-Sided|95.0|0.19|2.7||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659464|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|7.61|||<|0.001|2-Sided|95.0|5.78|9.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659465|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|8.66|||<|0.001|2-Sided|95.0|6.83|10.49||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659466|NCT01559259|3053498|Superiority or Other (legacy)||LS Mean difference|8.14|||<|0.001|2-Sided|95.0|6.33|9.95||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659467|NCT01559259|3053498|Superiority or Other (legacy)||LS mean difference|9.06|||<|0.001|2-Sided|95.0|7.23|10.89||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR, baseline numerical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1660090|NCT01557322|3053731|Superiority or Other|||||||0.4238|||||||Chi-squared|||Hospitalization Due to AE, Month 24: p-value was calculated using chi-square test.|
1659468|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|0.93||||0.462|2-Sided|95.0|-1.55|3.41||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659469|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|-0.78||||0.534|2-Sided|95.0|-3.25|1.69||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659470|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|-0.07||||0.957|2-Sided|95.0|-2.55|2.42||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659471|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|11.72|||<|0.001|2-Sided|95.0|8.18|15.26||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659472|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|12.65|||<|0.001|2-Sided|95.0|9.1|16.2||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659473|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|10.94|||<|0.001|2-Sided|95.0|7.4|14.48||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659474|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|11.65|||<|0.001|2-Sided|95.0|8.1|15.2||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-12 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659475|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|1.09|||<|0.21|2-Sided|95.0|-0.62|2.79||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659476|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|-0.14|||<|0.873|2-Sided|95.0|-1.83|1.56||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659477|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|0.6|||<|0.492|2-Sided|95.0|-1.11|2.3||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659478|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|9.63|||<|0.001|2-Sided|95.0|7.19|12.06||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659479|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|10.72|||<|0.001|2-Sided|95.0|8.28|13.15||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659480|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|9.49|||<|0.001|2-Sided|95.0|7.06|11.92||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659481|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|10.22|||<|0.001|2-Sided|95.0|7.78|12.66||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-8 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659501|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.54||||0.228|2-Sided|95.0|-0.34|1.41|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660744|NCT01543685|3055171|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1659482|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|1.06|||<|0.099|2-Sided|95.0|-0.2|2.31||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659483|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|0.04|||<|0.956|2-Sided|95.0|-1.21|1.28||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659484|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|0.74|||<|0.25|2-Sided|95.0|-0.52|1.99||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659485|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|7.65|||<|0.001|2-Sided|95.0|5.86|9.44||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659486|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|8.7|||<|0.001|2-Sided|95.0|6.91|10.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659487|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|7.68|||<|0.001|2-Sided|95.0|5.89|9.47||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659488|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|8.38|||<|0.001|2-Sided|95.0|6.59|10.18||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-6 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659489|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|0.47|||<|0.01|2-Sided|95.0|0.11|0.84||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659490|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|0.14|||<|0.428|2-Sided|95.0|-0.21|0.5||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659491|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|0.44|||<|0.016|2-Sided|95.0|0.08|0.81||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - Ibuprofen 400 mg) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659492|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|2.09|||<|0.001|2-Sided|95.0|1.57|2.6||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 400 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659493|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|2.56|||<|0.001|2-Sided|95.0|2.04|3.08||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 300 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659494|NCT01559259|3053499|Superiority or Other (legacy)||LS Mean difference|2.23|||<|0.001|2-Sided|95.0|1.72|2.75||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 250 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659495|NCT01559259|3053499|Superiority or Other (legacy)||LS mean difference|2.53|||<|0.001|2-Sided|95.0|2.01|3.05||p-value was calculated using ANOVA model with treatment, baseline categorical PSR, treatment-by-baseline categorical PSR and gender terms used as covariates. Statistical testing was done at 5% significance level.|ANOVA|||0-2 hours: Treatment difference (Ibuprofen 200 mg + Acetaminophen 500 mg - placebo) and corresponding 95% CI were calculated based on LSM from the ANOVA model.|
1659496|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.18||||0.556|2-Sided|95.0|-0.8|0.43|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660091|NCT01557322|3053731|Superiority or Other|||||||0.4532|||||||Chi-squared|||Hospitalization Due to AE, Month 18: p-value was calculated using chi-square test.|
1659502|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.42||||0.345|2-Sided|95.0|-0.46|1.3|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659503|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.12||||0.724|2-Sided|95.0|-0.79|0.55|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659504|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.56||||0.096|2-Sided|95.0|-1.22|0.1|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659505|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.66||||0.054|2-Sided|95.0|-1.32|0.01|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659506|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|1.31||||0.007|2-Sided|95.0|0.36|2.26|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659507|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|1.19||||0.014|2-Sided|95.0|0.24|2.15|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659508|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.75||||0.12|2-Sided|95.0|-0.2|1.7|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659509|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.66||||0.175|2-Sided|95.0|-0.3|1.61|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659510|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.1||||0.763|2-Sided|95.0|-0.57|0.78|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659511|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.44||||0.201|2-Sided|95.0|-1.11|0.23|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659512|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.47||||0.171|2-Sided|95.0|-1.15|0.2|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659513|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|1.48||||0.003|2-Sided|95.0|0.52|2.45|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659514|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|1.59||||0.001|2-Sided|95.0|0.62|2.56|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659515|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|1.05||||0.034|2-Sided|95.0|0.08|2.01|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659516|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|1.01||||0.041|2-Sided|95.0|0.04|1.98|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659517|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.04||||0.916|2-Sided|95.0|-0.66|0.73|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659518|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.37||||0.288|2-Sided|95.0|-1.06|0.32|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659519|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.34||||0.33|2-Sided|95.0|-1.04|0.35|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659520|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|1.91|||<|0.001|2-Sided|95.0|0.92|2.9|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659521|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|1.95|||<|0.001|2-Sided|95.0|0.95|2.94|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659522|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|1.54|||<|0.002|2-Sided|95.0|0.55|2.53|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659523|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|1.57|||<|0.002|2-Sided|95.0|0.57|2.56|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660024|NCT01558271|3053625|Superiority or Other||LS Mean Difference|1.91||||0.376|2-Sided|95.0|-2.32|6.13||Treatment comparison for HOMA2-%B based on fasting C-peptide at 26 weeks between LY2189265 and Liraglutide.|ANCOVA||||
1659524|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.18|||<|0.616|2-Sided|95.0|-0.87|0.52|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659525|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.25|||<|0.469|2-Sided|95.0|-0.95|0.44|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659526|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.36|||<|0.314|2-Sided|95.0|-1.05|0.34|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659527|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|2.42|||<|0.001|2-Sided|95.0|1.43|3.41|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659528|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|2.24|||<|0.001|2-Sided|95.0|1.25|3.24|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659529|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|2.17|||<|0.001|2-Sided|95.0|1.17|3.16|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659530|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|2.06|||<|0.001|2-Sided|95.0|1.07|3.06|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659531|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.24|||<|0.482|2-Sided|95.0|-0.44|0.93|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659532|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.16|||<|0.64|2-Sided|95.0|-0.84|0.52|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659533|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.05|||<|0.882|2-Sided|95.0|-0.74|0.63|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659534|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|2.75|||<|0.001|2-Sided|95.0|1.77|3.72|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659535|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|2.99|||<|0.001|2-Sided|95.0|2.01|3.97|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659536|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|2.58|||<|0.001|2-Sided|95.0|1.61|3.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659537|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|2.69|||<|0.001|2-Sided|95.0|1.72|3.67|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659538|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.47|||<|0.17|2-Sided|95.0|-0.2|1.14|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659539|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.05|||<|0.89|2-Sided|95.0|-0.71|0.62|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659540|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.13|||<|0.704|2-Sided|95.0|-0.54|0.8|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659541|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.04|||<|0.001|2-Sided|95.0|2.09|4.0|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659542|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.51|||<|0.001|2-Sided|95.0|2.55|4.47|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659543|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|2.99|||<|0.001|2-Sided|95.0|2.04|3.95|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659544|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.17|||<|0.001|2-Sided|95.0|2.21|4.13|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659545|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.29|||<|0.361|2-Sided|95.0|-0.34|0.92|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660025|NCT01558271|3053625|Superiority or Other||LS Mean Difference|24.82|||<|0.001|2-Sided|95.0|19.25|30.4||Treatment comparison for HOMA2-%B based on fasting C-peptide at 26 weeks between LY2189265 and placebo.|ANCOVA||||
1659546|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.23|||<|0.467|2-Sided|95.0|-0.86|0.39|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659547|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.2|||<|0.536|2-Sided|95.0|-0.43|0.83|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659548|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.6|||<|0.001|2-Sided|95.0|2.7|4.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659549|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.89|||<|0.001|2-Sided|95.0|2.99|4.79|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659550|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.37|||<|0.001|2-Sided|95.0|2.47|4.26|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659551|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.8|||<|0.001|2-Sided|95.0|2.9|4.7|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659552|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.37|||<|0.226|2-Sided|95.0|-0.23|0.97|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659553|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.05|||<|0.866|2-Sided|95.0|-0.65|0.55|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659554|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.26|||<|0.397|2-Sided|95.0|-0.34|0.86|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659555|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.68|||<|0.001|2-Sided|95.0|2.82|4.54|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659556|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|4.06|||<|0.001|2-Sided|95.0|3.19|4.92|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659557|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.63|||<|0.001|2-Sided|95.0|2.77|4.49|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659558|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.94|||<|0.001|2-Sided|95.0|3.08|4.81|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659559|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.27|||<|0.368|2-Sided|95.0|-0.32|0.86|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659560|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.13|||<|0.667|2-Sided|95.0|-0.71|0.45|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659561|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.22|||<|0.464|2-Sided|95.0|-0.37|0.81|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659562|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.89|||<|0.001|2-Sided|95.0|3.05|4.72|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659563|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|4.15|||<|0.001|2-Sided|95.0|3.32|4.99|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659564|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.76|||<|0.001|2-Sided|95.0|2.92|4.59|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659565|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|4.1|||<|0.001|2-Sided|95.0|3.27|4.94|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659566|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.45|||<|0.112|2-Sided|95.0|-0.11|1.02|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659567|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|-0.03|||<|0.922|2-Sided|95.0|-0.59|0.53|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660026|NCT01558271|3053625|Superiority or Other||LS Mean Difference|3.08|||<|0.242|2-Sided|95.0|-2.09|8.24||Treatment comparison for HOMA2-%B based on fasting insulin at 26 weeks between LY2189265 and Liraglutide.|ANCOVA||||
1659568|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.29|||<|0.317|2-Sided|95.0|-0.28|0.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659569|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.89|||<|0.001|2-Sided|95.0|3.09|4.69|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659570|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|4.34|||<|0.001|2-Sided|95.0|3.54|5.14|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659571|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.86|||<|0.001|2-Sided|95.0|3.06|4.66|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659572|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|4.17|||<|0.001|2-Sided|95.0|3.37|4.98|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659573|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.55|||<|0.042|2-Sided|95.0|0.02|1.08|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659574|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.07|||<|0.789|2-Sided|95.0|-0.46|0.6|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659575|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.52|||<|0.056|2-Sided|95.0|-0.01|1.05|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659576|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.48|||<|0.001|2-Sided|95.0|2.72|4.24|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659577|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|4.03|||<|0.001|2-Sided|95.0|3.27|4.79|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659578|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.55|||<|0.001|2-Sided|95.0|2.79|4.31|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659579|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|4.0|||<|0.001|2-Sided|95.0|3.24|4.76|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659580|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.71|||<|0.01|2-Sided|95.0|0.17|1.24|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659581|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.35|||<|0.202|2-Sided|95.0|-0.19|0.88|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659582|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.67|||<|0.014|2-Sided|95.0|0.14|1.21|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659583|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|2.78|||<|0.001|2-Sided|95.0|2.02|3.54|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659584|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.49|||<|0.001|2-Sided|95.0|2.72|4.26|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659585|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.13|||<|0.001|2-Sided|95.0|2.36|3.89|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659586|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|3.45|||<|0.001|2-Sided|95.0|2.69|4.22|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659587|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.77|||<|0.002|2-Sided|95.0|0.28|1.27|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659588|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.62|||<|0.014|2-Sided|95.0|0.12|1.11|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659589|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.83|||<|0.001|2-Sided|95.0|0.34|1.33|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660027|NCT01558271|3053625|Superiority or Other||LS Mean Difference|28.35|||<|0.001|2-Sided|95.0|21.63|35.07||Treatment comparison for HOMA2-%B based on fasting insulin at 26 weeks between LY2189265 and placebo.|ANCOVA||||
1659590|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|1.32|||<|0.001|2-Sided|95.0|0.61|2.02|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659591|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|2.09|||<|0.001|2-Sided|95.0|1.39|2.8|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659592|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|1.93|||<|0.001|2-Sided|95.0|1.23|2.64|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659593|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|2.15|||<|0.001|2-Sided|95.0|1.45|2.86|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659594|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.42|||<|0.017|2-Sided|95.0|0.08|0.76|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659595|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.16|||<|0.354|2-Sided|95.0|-0.18|0.5|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659596|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.32|||<|0.067|2-Sided|95.0|-0.02|0.66|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659597|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.3|||<|0.232|2-Sided|95.0|-0.19|0.78|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659598|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.71|||<|0.004|2-Sided|95.0|0.22|1.2|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659599|NCT01559259|3053500|Superiority or Other (legacy)||LS Mean difference|0.46|||<|0.066|2-Sided|95.0|-0.03|0.94|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659600|NCT01559259|3053500|Superiority or Other (legacy)||LS mean difference|0.62|||<|0.014|2-Sided|95.0|0.13|1.1|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659601|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.44||||0.284|2-Sided|95.0|-1.25|0.37|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659602|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.56||||0.16|2-Sided|95.0|-1.35|0.22|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659603|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-1.01||||0.014|2-Sided|95.0|-1.82|-0.2|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659604|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|1.75||||0.004|2-Sided|95.0|0.57|2.93|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659605|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|1.31||||0.03|2-Sided|95.0|0.13|2.49|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659606|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|1.19||||0.046|2-Sided|95.0|0.02|2.35|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659607|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.74||||0.218|2-Sided|95.0|-0.44|1.92|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659608|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.35||||0.437|2-Sided|95.0|-1.23|0.53|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659609|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.49||||0.269|2-Sided|95.0|-1.35|0.38|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659610|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.76||||0.094|2-Sided|95.0|-1.64|0.13|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659611|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|2.08||||0.002|2-Sided|95.0|0.78|3.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659612|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|1.73||||0.009|2-Sided|95.0|0.43|3.02|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659613|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|1.59||||0.015|2-Sided|95.0|0.31|2.87|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659614|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|1.32||||0.045|2-Sided|95.0|0.03|2.61|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659615|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.11||||0.812|2-Sided|95.0|-1.03|0.81|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659616|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.52||||0.254|2-Sided|95.0|-1.42|0.38|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659617|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.78||||0.097|2-Sided|95.0|-1.7|0.14|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659618|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|2.4|||<|0.001|2-Sided|95.0|1.05|3.75|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659619|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|2.29|||<|0.001|2-Sided|95.0|0.94|3.63|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659620|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|1.88|||<|0.006|2-Sided|95.0|0.55|3.21|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659621|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|1.62|||<|0.018|2-Sided|95.0|0.27|2.97|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659622|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.15|||<|0.758|2-Sided|95.0|-1.1|0.8|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659623|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.4|||<|0.4|2-Sided|95.0|-1.32|0.53|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659624|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.54|||<|0.264|2-Sided|95.0|-1.49|0.41|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659625|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|2.85|||<|0.001|2-Sided|95.0|1.46|4.23|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659626|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|2.7|||<|0.001|2-Sided|95.0|1.31|4.08|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659627|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|2.45|||<|0.001|2-Sided|95.0|1.08|3.82|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659628|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|2.31|||<|0.001|2-Sided|95.0|0.92|3.69|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659629|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.45|||<|0.356|2-Sided|95.0|-1.41|0.51|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659630|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.31|||<|0.522|2-Sided|95.0|-1.24|0.63|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659631|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.59|||<|0.232|2-Sided|95.0|-1.55|0.38|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659632|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|3.57|||<|0.001|2-Sided|95.0|2.16|4.98|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660745|NCT01543685|3055172|Superiority or Other|||||||0.016|||||||t-test, 2 sided||||
1659633|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|3.12|||<|0.001|2-Sided|95.0|1.71|4.52|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659634|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|3.27|||<|0.001|2-Sided|95.0|1.88|4.65|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659635|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|2.98|||<|0.001|2-Sided|95.0|1.58|4.39|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659636|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.1|||<|0.827|2-Sided|95.0|-0.83|1.04|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659637|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.1|||<|0.824|2-Sided|95.0|-1.02|0.81|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659638|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.25|||<|0.607|2-Sided|95.0|-1.18|0.69|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659639|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|4.01|||<|0.001|2-Sided|95.0|2.64|5.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659640|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|4.12|||<|0.001|2-Sided|95.0|2.75|5.48|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659641|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|3.91|||<|0.001|2-Sided|95.0|2.56|5.26|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659642|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|3.77|||<|0.001|2-Sided|95.0|2.4|5.13|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659643|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.51|||<|0.274|2-Sided|95.0|-0.41|1.44|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659644|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.05|||<|0.907|2-Sided|95.0|-0.85|0.95|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659645|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.16|||<|0.741|2-Sided|95.0|-0.77|1.08|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659646|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|4.39|||<|0.001|2-Sided|95.0|3.04|5.74|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659647|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|4.91|||<|0.001|2-Sided|95.0|3.56|6.26|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659648|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|4.45|||<|0.001|2-Sided|95.0|3.11|5.78|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659649|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|4.55|||<|0.001|2-Sided|95.0|3.2|5.9|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659650|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.21|||<|0.638|2-Sided|95.0|-0.66|1.08|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659651|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.13|||<|0.762|2-Sided|95.0|-0.98|0.72|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659652|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.38|||<|0.392|2-Sided|95.0|-0.49|1.25|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659653|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.06|||<|0.001|2-Sided|95.0|3.79|6.34|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660746|NCT01543685|3055172|Superiority or Other|||||||0.01|||||||t-test, 2 sided||||
1659654|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.27|||<|0.001|2-Sided|95.0|4.0|6.54|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659655|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|4.93|||<|0.001|2-Sided|95.0|3.68|6.19|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659656|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.44|||<|0.001|2-Sided|95.0|4.17|6.71|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659657|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.25|||<|0.556|2-Sided|95.0|-0.59|1.1|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659658|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.07|||<|0.86|2-Sided|95.0|-0.9|0.75|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659659|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.28|||<|0.518|2-Sided|95.0|-0.57|1.12|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659660|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.17|||<|0.001|2-Sided|95.0|3.94|6.4|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659661|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.42|||<|0.001|2-Sided|95.0|4.19|6.66|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659662|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.1|||<|0.001|2-Sided|95.0|3.88|6.31|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659663|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.45|||<|0.001|2-Sided|95.0|4.22|6.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659664|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.25|||<|0.553|2-Sided|95.0|-0.57|1.06|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659665|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|-0.05|||<|0.908|2-Sided|95.0|-0.84|0.75|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659666|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.37|||<|0.367|2-Sided|95.0|-0.44|1.19|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659667|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.35|||<|0.001|2-Sided|95.0|4.17|6.54|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659668|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.6|||<|0.001|2-Sided|95.0|4.41|6.78|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659669|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.31|||<|0.001|2-Sided|95.0|4.13|6.48|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659670|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.73|||<|0.001|2-Sided|95.0|4.54|6.91|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659671|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.45|||<|0.268|2-Sided|95.0|-0.34|1.24|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659672|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.08|||<|0.831|2-Sided|95.0|-0.69|0.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659673|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.52|||<|0.2|2-Sided|95.0|-0.27|1.31|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659674|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.34|||<|0.001|2-Sided|95.0|4.19|6.5|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660747|NCT01543685|3055172|Superiority or Other|||||||0.008|||||||t-test, 2 sided||||
1659675|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.79|||<|0.001|2-Sided|95.0|4.64|6.94|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659676|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.43|||<|0.001|2-Sided|95.0|4.29|6.57|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659677|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.86|||<|0.001|2-Sided|95.0|4.71|7.01|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659678|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.51|||<|0.181|2-Sided|95.0|-0.24|1.27|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659679|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.16|||<|0.666|2-Sided|95.0|-0.57|0.9|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659680|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.74|||<|0.055|2-Sided|95.0|-0.01|1.49|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659681|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|4.88|||<|0.001|2-Sided|95.0|3.78|5.98|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659682|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.4|||<|0.001|2-Sided|95.0|4.3|6.5|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659683|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.04|||<|0.001|2-Sided|95.0|3.96|6.13|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659684|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|5.62|||<|0.001|2-Sided|95.0|4.52|6.72|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659685|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.55|||<|0.152|2-Sided|95.0|-0.2|1.3|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659686|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.29|||<|0.442|2-Sided|95.0|-0.44|1.02|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659687|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.83|||<|0.031|2-Sided|95.0|0.08|1.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659688|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|3.92|||<|0.001|2-Sided|95.0|2.83|5.02|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659689|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|4.47|||<|0.001|2-Sided|95.0|3.37|5.56|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659690|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|4.21|||<|0.001|2-Sided|95.0|3.13|5.29|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659691|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|4.75|||<|0.001|2-Sided|95.0|3.65|5.84|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659692|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.75|||<|0.027|2-Sided|95.0|0.09|1.41|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659693|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.76|||<|0.021|2-Sided|95.0|0.11|1.41|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659694|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|1.13|||<|0.001|2-Sided|95.0|0.47|1.79|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659695|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|1.76|||<|0.001|2-Sided|95.0|0.79|2.72|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660748|NCT01543685|3055172|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1659696|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|2.51|||<|0.001|2-Sided|95.0|1.54|3.47|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659697|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|2.52|||<|0.001|2-Sided|95.0|1.56|3.47|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659698|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|2.89|||<|0.001|2-Sided|95.0|1.92|3.85|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659699|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.43|||<|0.054|2-Sided|95.0|-0.01|0.86|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659700|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.31|||<|0.15|2-Sided|95.0|-0.11|0.73|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659701|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.5|||<|0.024|2-Sided|95.0|0.07|0.93|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659702|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.38|||<|0.237|2-Sided|95.0|-0.25|1.01|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659703|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.81|||<|0.012|2-Sided|95.0|0.17|1.44|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659704|NCT01559259|3053501|Superiority or Other (legacy)||LS Mean difference|0.69|||<|0.03|2-Sided|95.0|0.07|1.31|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659705|NCT01559259|3053501|Superiority or Other (legacy)||LS mean difference|0.88|||<|0.006|2-Sided|95.0|0.25|1.51|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, baseline numerical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659706|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.11||||0.353|2-Sided|95.0|-0.35|0.13|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659707|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.18||||0.138|2-Sided|95.0|-0.42|0.06|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659708|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.23||||0.061|2-Sided|95.0|-0.47|0.01|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659709|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.38||||0.031|2-Sided|95.0|0.03|0.72|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659710|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.26||||0.134|2-Sided|95.0|-0.08|0.61|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659711|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.2||||0.261|2-Sided|95.0|-0.15|0.54|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659712|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.15||||0.402|2-Sided|95.0|-0.2|0.49|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659713|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.07||||0.59|2-Sided|95.0|-0.34|0.19|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659714|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.18||||0.175|2-Sided|95.0|-0.44|0.08|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659715|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.2||||0.135|2-Sided|95.0|-0.47|0.06|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659716|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.49||||0.011|2-Sided|95.0|0.11|0.87|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659717|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.42||||0.031|2-Sided|95.0|0.04|0.79|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659718|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.31||||0.111|2-Sided|95.0|-0.07|0.68|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659719|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.29||||0.138|2-Sided|95.0|-0.09|0.66|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659720|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.03||||0.849|2-Sided|95.0|-0.25|0.3|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659721|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.14||||0.318|2-Sided|95.0|-0.41|0.13|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659722|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.15||||0.276|2-Sided|95.0|-0.42|0.12|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659723|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.53||||0.007|2-Sided|95.0|0.14|0.92|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659724|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.56||||0.005|2-Sided|95.0|0.17|0.95|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659725|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.39||||0.047|2-Sided|95.0|0.01|0.78|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659726|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.38||||0.056|2-Sided|95.0|-0.01|0.77|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659727|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.0||||0.997|2-Sided|95.0|-0.28|0.28|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659728|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.14||||0.315|2-Sided|95.0|-0.42|0.14|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659729|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.08||||0.567|2-Sided|95.0|-0.36|0.2|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659730|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.7|||<|0.001|2-Sided|95.0|0.29|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659731|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.69|||<|0.001|2-Sided|95.0|0.29|1.1|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659732|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.55|||<|0.007|2-Sided|95.0|0.15|0.95|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659733|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.61|||<|0.003|2-Sided|95.0|0.21|1.02|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659734|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.06|||<|0.652|2-Sided|95.0|-0.35|0.22|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659735|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.12|||<|0.408|2-Sided|95.0|-0.4|0.16|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659736|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.11|||<|0.441|2-Sided|95.0|-0.39|0.17|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659737|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.92|||<|0.001|2-Sided|95.0|0.52|1.33|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659738|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.86|||<|0.001|2-Sided|95.0|0.46|1.26|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659739|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.81|||<|0.001|2-Sided|95.0|0.4|1.21|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660028|NCT01558271|3053626|Superiority or Other||LS Mean Difference|-1.03||||0.747|2-Sided|95.0|-7.32|5.25||Treatment comparison for HOMA2-%S based on fasting C-peptide at 52 weeks between LY2189265 and Liraglutide.|ANCOVA||||
1659740|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.81|||<|0.001|2-Sided|95.0|0.41|1.22|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659741|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.1|||<|0.496|2-Sided|95.0|-0.18|0.38|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659742|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.05|||<|0.702|2-Sided|95.0|-0.33|0.23|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659743|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.03|||<|0.846|2-Sided|95.0|-0.31|0.25|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659744|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.06|||<|0.001|2-Sided|95.0|0.66|1.46|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659745|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.15|||<|0.001|2-Sided|95.0|0.75|1.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659746|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.0|||<|0.001|2-Sided|95.0|0.6|1.4|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659747|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.03|||<|0.001|2-Sided|95.0|0.63|1.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659748|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.2|||<|0.164|2-Sided|95.0|-0.08|0.47|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659749|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.0|||<|0.977|2-Sided|95.0|-0.27|0.28|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659750|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.03|||<|0.811|2-Sided|95.0|-0.24|0.31|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659751|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.17|||<|0.001|2-Sided|95.0|0.77|1.56|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659752|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.36|||<|0.001|2-Sided|95.0|0.97|1.76|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659753|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.17|||<|0.001|2-Sided|95.0|0.78|1.57|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659754|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.2|||<|0.001|2-Sided|95.0|0.81|1.6|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659755|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.12|||<|0.36|2-Sided|95.0|-0.14|0.38|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659756|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.09|||<|0.517|2-Sided|95.0|-0.35|0.17|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659757|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.07|||<|0.587|2-Sided|95.0|-0.19|0.33|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659758|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.4|||<|0.001|2-Sided|95.0|1.03|1.78|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659759|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.53|||<|0.001|2-Sided|95.0|1.15|1.9|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659760|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.32|||<|0.001|2-Sided|95.0|0.94|1.69|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659761|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.48|||<|0.001|2-Sided|95.0|1.1|1.85|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660029|NCT01558271|3053626|Superiority or Other||LS Mean Difference|-2.49||||0.533|2-Sided|95.0|-10.35|5.36||Treatment comparison for HOMA2-%S based on fasting insulin at 52 weeks between LY2189265 and Liraglutide.|ANCOVA||||
1659762|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.16|||<|0.228|2-Sided|95.0|-0.1|0.41|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659763|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.0|||<|0.991|2-Sided|95.0|-0.25|0.25|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659764|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.09|||<|0.483|2-Sided|95.0|-0.16|0.34|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659765|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.46|||<|0.001|2-Sided|95.0|1.1|1.82|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659766|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.61|||<|0.001|2-Sided|95.0|1.25|1.97|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659767|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.46|||<|0.001|2-Sided|95.0|1.1|1.82|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659768|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.55|||<|0.001|2-Sided|95.0|1.19|1.91|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659769|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.11|||<|0.384|2-Sided|95.0|-0.14|0.36|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659770|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.03|||<|0.816|2-Sided|95.0|-0.28|0.22|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659771|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.1|||<|0.453|2-Sided|95.0|-0.15|0.34|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659772|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.53|||<|0.001|2-Sided|95.0|1.18|1.89|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659773|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.64|||<|0.001|2-Sided|95.0|1.29|2.0|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659774|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.5|||<|0.001|2-Sided|95.0|1.15|1.86|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659775|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.63|||<|0.001|2-Sided|95.0|1.27|1.98|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659776|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.18|||<|0.126|2-Sided|95.0|-0.05|0.42|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659777|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|-0.01|||<|0.943|2-Sided|95.0|-0.24|0.23|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659778|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.11|||<|0.342|2-Sided|95.0|-0.12|0.35|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659779|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.52|||<|0.001|2-Sided|95.0|1.19|1.86|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659780|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.71|||<|0.001|2-Sided|95.0|1.37|2.05|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659781|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.52|||<|0.001|2-Sided|95.0|1.18|1.85|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659782|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.64|||<|0.001|2-Sided|95.0|1.3|1.98|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659783|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.23|||<|0.051|2-Sided|95.0|0.0|0.45|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660030|NCT01558271|3053626|Superiority or Other||LS Mean Difference|-3.03||||0.357|2-Sided|95.0|-9.48|3.42||Treatment comparison for HOMA2-%S based on fasting C-peptide at 26 weeks between LY2189265 and Liraglutide.|ANCOVA||||
1659784|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.04|||<|0.759|2-Sided|95.0|-0.19|0.26|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659785|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.22|||<|0.056|2-Sided|95.0|-0.01|0.45|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659786|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.35|||<|0.001|2-Sided|95.0|1.02|1.67|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659787|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.57|||<|0.001|2-Sided|95.0|1.25|1.9|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659788|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.38|||<|0.001|2-Sided|95.0|1.06|1.7|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659789|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.57|||<|0.001|2-Sided|95.0|1.24|1.89|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659790|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.31|||<|0.007|2-Sided|95.0|0.09|0.53|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659791|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.13|||<|0.267|2-Sided|95.0|-0.1|0.35|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659792|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.29|||<|0.011|2-Sided|95.0|0.07|0.52|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659793|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.04|||<|0.001|2-Sided|95.0|0.72|1.36|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659794|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.35|||<|0.001|2-Sided|95.0|1.03|1.67|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659795|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.17|||<|0.001|2-Sided|95.0|0.85|1.49|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659796|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|1.33|||<|0.001|2-Sided|95.0|1.01|1.65|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659797|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.29|||<|0.006|2-Sided|95.0|0.08|0.5|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659798|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.22|||<|0.039|2-Sided|95.0|0.01|0.42|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659799|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.37|||<|0.001|2-Sided|95.0|0.16|0.58|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659800|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.45|||<|0.003|2-Sided|95.0|0.16|0.75|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659801|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.74|||<|0.001|2-Sided|95.0|0.45|1.04|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659802|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.67|||<|0.001|2-Sided|95.0|0.37|0.97|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659803|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.82|||<|0.001|2-Sided|95.0|0.52|1.12|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659804|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.16|||<|0.023|2-Sided|95.0|0.02|0.31|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659805|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.06|||<|0.435|2-Sided|95.0|-0.08|0.2|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660031|NCT01558271|3053626|Superiority or Other||LS Mean Difference|0.83||||0.848|2-Sided|95.0|-7.72|9.38||Treatment comparison for HOMA2-%S based on fasting C-peptide at 26 weeks between LY2189265 and placebo.|ANCOVA||||
1659806|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.15|||<|0.036|2-Sided|95.0|0.01|0.29|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659807|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.07|||<|0.501|2-Sided|95.0|-0.13|0.27|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659808|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.23|||<|0.024|2-Sided|95.0|0.03|0.44|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659809|NCT01559259|3053502|Superiority or Other (legacy)||LS Mean difference|0.13|||<|0.224|2-Sided|95.0|-0.08|0.33|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659810|NCT01559259|3053502|Superiority or Other (legacy)||LS mean difference|0.22|||<|0.033|2-Sided|95.0|0.02|0.42|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659811|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.07||||0.721|2-Sided|95.0|-0.46|0.32|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659812|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.36||||0.064|2-Sided|95.0|-0.75|0.02|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659813|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.43||||0.03|2-Sided|95.0|-0.81|-0.04|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659814|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.7||||0.012|2-Sided|95.0|0.15|1.25|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659815|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.63||||0.025|2-Sided|95.0|0.08|1.19|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659816|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.34||||0.224|2-Sided|95.0|-0.21|0.89|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659817|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.28||||0.327|2-Sided|95.0|-0.28|0.83|||ANOVA|||12 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659818|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.05||||0.822|2-Sided|95.0|-0.46|0.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659819|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.38||||0.07|2-Sided|95.0|-0.79|0.03|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659820|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.45||||0.031|2-Sided|95.0|-0.87|-0.04|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659821|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.83||||0.006|2-Sided|95.0|0.24|1.41|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659822|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.78||||0.01|2-Sided|95.0|0.19|1.37|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659823|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.45||||0.136|2-Sided|95.0|-0.14|1.03|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659824|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.37||||0.217|2-Sided|95.0|-0.22|0.96|||ANOVA|||11 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659825|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.08||||0.714|2-Sided|95.0|-0.34|0.49|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659826|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.3||||0.154|2-Sided|95.0|-0.71|0.11|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659827|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.32||||0.129|2-Sided|95.0|-0.74|0.09|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660032|NCT01558271|3053626|Superiority or Other||LS Mean Difference|-0.01||||0.998|2-Sided|95.0|-7.92|7.91||Treatment comparison for HOMA2-%S based on fasting insulin at 26 weeks between LY2189265 and Liraglutide.|ANCOVA||||
1659828|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.95||||0.002|2-Sided|95.0|0.36|1.54|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659829|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.03|||<|0.001|2-Sided|95.0|0.43|1.62|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659830|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.65|||<|0.031|2-Sided|95.0|0.06|1.24|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659831|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.63|||<|0.038|2-Sided|95.0|0.03|1.22|||ANOVA|||10 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659832|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.04|||<|0.86|2-Sided|95.0|-0.39|0.46|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659833|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.23|||<|0.283|2-Sided|95.0|-0.65|0.19|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659834|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.26|||<|0.224|2-Sided|95.0|-0.69|0.16|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659835|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.22|||<|0.001|2-Sided|95.0|0.61|1.82|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659836|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.25|||<|0.001|2-Sided|95.0|0.65|1.86|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659837|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.98|||<|0.001|2-Sided|95.0|0.38|1.59|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659838|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.95|||<|0.002|2-Sided|95.0|0.34|1.56|||ANOVA|||9 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659839|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.11|||<|0.602|2-Sided|95.0|-0.54|0.31|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659840|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.14|||<|0.526|2-Sided|95.0|-0.56|0.29|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659841|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.25|||<|0.256|2-Sided|95.0|-0.67|0.18|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659842|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.5|||<|0.001|2-Sided|95.0|0.89|2.1|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659843|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.38|||<|0.001|2-Sided|95.0|0.77|1.99|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659844|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.36|||<|0.001|2-Sided|95.0|0.75|1.97|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659845|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.25|||<|0.001|2-Sided|95.0|0.64|1.86|||ANOVA|||8 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659846|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.15|||<|0.484|2-Sided|95.0|-0.27|0.56|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659847|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.11|||<|0.607|2-Sided|95.0|-0.52|0.3|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659848|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.02|||<|0.91|2-Sided|95.0|-0.44|0.39|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659849|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.69|||<|0.001|2-Sided|95.0|1.1|2.28|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660033|NCT01558271|3053626|Superiority or Other||LS Mean Difference|-1.86||||0.723|2-Sided|95.0|-12.2|8.48||Treatment comparison for HOMA2-%S based on fasting insulin at 26 weeks between LY2189265 and placebo.|ANCOVA||||
1659850|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.84|||<|0.001|2-Sided|95.0|1.25|2.43|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659851|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.58|||<|0.001|2-Sided|95.0|0.99|2.17|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659852|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.67|||<|0.001|2-Sided|95.0|1.07|2.26|||ANOVA|||7 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659853|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.27|||<|0.184|2-Sided|95.0|-0.13|0.67|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659854|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.05|||<|0.803|2-Sided|95.0|-0.45|0.35|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659855|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.1|||<|0.639|2-Sided|95.0|-0.31|0.5|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659856|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.87|||<|0.001|2-Sided|95.0|1.3|2.45|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659857|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.15|||<|0.001|2-Sided|95.0|1.57|2.72|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659858|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.82|||<|0.001|2-Sided|95.0|1.25|2.4|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659859|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.97|||<|0.001|2-Sided|95.0|1.39|2.55|||ANOVA|||6 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659860|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.17|||<|0.372|2-Sided|95.0|-0.2|0.54|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659861|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.15|||<|0.442|2-Sided|95.0|-0.52|0.23|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659862|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.13|||<|0.51|2-Sided|95.0|-0.25|0.5|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659863|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.2|||<|0.001|2-Sided|95.0|1.66|2.73|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659864|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.37|||<|0.001|2-Sided|95.0|1.83|2.9|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659865|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.05|||<|0.001|2-Sided|95.0|1.52|2.58|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659866|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.32|||<|0.001|2-Sided|95.0|1.79|2.86|||ANOVA|||5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659867|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.22|||<|0.235|2-Sided|95.0|-0.14|0.58|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659868|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.05|||<|0.771|2-Sided|95.0|-0.41|0.3|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659869|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.17|||<|0.352|2-Sided|95.0|-0.19|0.53|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659870|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.23|||<|0.001|2-Sided|95.0|1.72|2.74|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659871|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.44|||<|0.001|2-Sided|95.0|1.93|2.96|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660034|NCT01558271|3053627|Superiority or Other||LS Mean Difference|-0.03||||0.911|2-Sided|95.0|-0.64|0.57||Treatment comparison for body weight at 52 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis||||
1659872|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.17|||<|0.001|2-Sided|95.0|1.66|2.68|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659873|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.4|||<|0.001|2-Sided|95.0|1.88|2.91|||ANOVA|||4 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659874|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.16|||<|0.368|2-Sided|95.0|-0.19|0.5|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659875|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.1|||<|0.573|2-Sided|95.0|-0.44|0.24|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659876|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.12|||<|0.482|2-Sided|95.0|-0.22|0.47|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659877|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.35|||<|0.001|2-Sided|95.0|1.86|2.85|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659878|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.51|||<|0.001|2-Sided|95.0|2.02|3.01|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659879|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.25|||<|0.001|2-Sided|95.0|1.76|2.75|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659880|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.48|||<|0.001|2-Sided|95.0|1.98|2.97|||ANOVA|||3 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659881|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.27|||<|0.113|2-Sided|95.0|-0.06|0.6|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659882|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|-0.02|||<|0.91|2-Sided|95.0|-0.35|0.31|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659883|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.17|||<|0.312|2-Sided|95.0|-0.16|0.51|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659884|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.36|||<|0.001|2-Sided|95.0|1.89|2.84|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659885|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.63|||<|0.001|2-Sided|95.0|2.15|3.11|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659886|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.34|||<|0.001|2-Sided|95.0|1.87|2.82|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659887|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.53|||<|0.001|2-Sided|95.0|2.06|3.01|||ANOVA|||2 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659888|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.33|||<|0.043|2-Sided|95.0|0.01|0.64|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659889|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.04|||<|0.817|2-Sided|95.0|-0.28|0.35|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659890|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.3|||<|0.065|2-Sided|95.0|-0.02|0.61|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659891|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.13|||<|0.001|2-Sided|95.0|1.68|2.58|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659892|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.46|||<|0.001|2-Sided|95.0|2.01|2.91|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659893|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.17|||<|0.001|2-Sided|95.0|1.72|2.62|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660035|NCT01558271|3053627|Superiority or Other||LS Mean Difference|0.34||||0.168|2-Sided|95.0|-0.14|0.82||Treatment comparison for body weight at 26 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis||||
1659894|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.43|||<|0.001|2-Sided|95.0|1.98|2.88|||ANOVA|||1.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659895|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.4|||<|0.016|2-Sided|95.0|0.07|0.72|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659896|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.22|||<|0.181|2-Sided|95.0|-0.1|0.54|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659897|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.38|||<|0.022|2-Sided|95.0|0.05|0.7|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659898|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.74|||<|0.001|2-Sided|95.0|1.28|2.2|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659899|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.14|||<|0.001|2-Sided|95.0|1.67|2.6|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659900|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.96|||<|0.001|2-Sided|95.0|1.5|2.42|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659901|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|2.12|||<|0.001|2-Sided|95.0|1.66|2.58|||ANOVA|||1 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659902|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.48|||<|0.002|2-Sided|95.0|0.18|0.79|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659903|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.4|||<|0.01|2-Sided|95.0|0.1|0.7|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659904|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.47|||<|0.003|2-Sided|95.0|0.16|0.77|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659905|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.87|||<|0.001|2-Sided|95.0|0.43|1.3|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659906|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.35|||<|0.001|2-Sided|95.0|0.91|1.78|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659907|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.26|||<|0.001|2-Sided|95.0|0.83|1.7|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659908|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|1.33|||<|0.001|2-Sided|95.0|0.9|1.77|||ANOVA|||0.5 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659909|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.25|||<|0.024|2-Sided|95.0|0.03|0.47|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659910|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.1|||<|0.35|2-Sided|95.0|-0.11|0.32|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659911|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.17|||<|0.135|2-Sided|95.0|-0.05|0.39|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659912|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.23|||<|0.155|2-Sided|95.0|-0.09|0.54|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659913|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.48|||<|0.003|2-Sided|95.0|0.17|0.79|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659914|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.33|||<|0.038|2-Sided|95.0|0.02|0.64|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659915|NCT01559259|3053503|Superiority or Other (legacy)||LS Mean difference|0.39|||<|0.014|2-Sided|95.0|0.08|0.71|||ANOVA|||0.25 hour: Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660036|NCT01558271|3053627|Superiority or Other||LS Mean Difference|0.61||||0.057|2-Sided|95.0|-0.02|1.23|||Mixed Models Analysis|Treatment comparison for body weight at 26 weeks between LY2189265 and placebo.|||
1659916|NCT01559259|3053504|Superiority or Other (legacy)||Hazard Ratio (HR)|1.41||||0.03|2-Sided|95.0|1.03|1.93|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659917|NCT01559259|3053504|Superiority or Other (legacy)||Hazard Ratio (HR)|1.09||||0.57|2-Sided|95.0|0.8|1.49|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659918|NCT01559259|3053504|Superiority or Other (legacy)||Hazard Ratio (HR)|1.49||||0.012|2-Sided|95.0|1.09|2.04|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659919|NCT01559259|3053504|Superiority or Other (legacy)||Hazard Ratio (HR)|8.11|||<|0.001|2-Sided|95.0|3.52|18.68|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659920|NCT01559259|3053504|Superiority or Other (legacy)||Hazard Ratio (HR)|11.47|||<|0.001|2-Sided|95.0|4.98|26.42|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659921|NCT01559259|3053504|Superiority or Other (legacy)||Hazard Ratio (HR)|8.88|||<|0.001|2-Sided|95.0|3.86|20.44|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659922|NCT01559259|3053504|Superiority or Other (legacy)||Hazard Ratio (HR)|12.1|||<|0.001|2-Sided|95.0|5.24|27.91|||Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659923|NCT01559259|3053505|Superiority or Other (legacy)||Hazard Ratio (HR)|1.36||||0.056|2-Sided|95.0|0.99|1.85|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659924|NCT01559259|3053505|Superiority or Other (legacy)||Hazard Ratio (HR)|1.17||||0.332|2-Sided|95.0|0.86|1.59|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659925|NCT01559259|3053505|Superiority or Other (legacy)||Hazard Ratio (HR)|1.48||||0.014|2-Sided|95.0|1.08|2.02|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659926|NCT01559259|3053505|Superiority or Other (legacy)||Hazard Ratio (HR)|8.6|||<|0.001|2-Sided|95.0|3.74|19.77|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659927|NCT01559259|3053505|Superiority or Other (legacy)||Hazard Ratio (HR)|11.66|||<|0.001|2-Sided|95.0|5.07|26.83|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659928|NCT01559259|3053505|Superiority or Other (legacy)||Hazard Ratio (HR)|10.02|||<|0.001|2-Sided|95.0|4.36|23.02|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659929|NCT01559259|3053505|Superiority or Other (legacy)||Hazard Ratio (HR)|12.69|||<|0.001|2-Sided|95.0|5.52|29.19|||Proportional hazards model|||Hazard ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model with treatment, baseline categorical PSR and gender terms used as covariates.|
1659930|NCT01559259|3053506|Superiority or Other (legacy)||LS Mean difference|2.62||||0.216|2-Sided|95.0|-1.53|6.78|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659931|NCT01559259|3053506|Superiority or Other (legacy)||LS Mean difference|-0.49||||0.817|2-Sided|95.0|-4.61|3.64|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659932|NCT01559259|3053506|Superiority or Other (legacy)||LS Mean difference|1.42||||0.501|2-Sided|95.0|-2.73|5.58|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659933|NCT01559259|3053506|Superiority or Other (legacy)||LS Mean difference|24.85|||<|0.001|2-Sided|95.0|18.93|30.78|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659934|NCT01559259|3053506|Superiority or Other (legacy)||LS Mean difference|27.48|||<|0.001|2-Sided|95.0|21.53|33.42|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659935|NCT01559259|3053506|Superiority or Other (legacy)||LS Mean difference|24.37|||<|0.001|2-Sided|95.0|18.44|30.29|||ANOVA|||Treatment difference and 95% CI were based on LSM from ANOVA with treatment, baseline categorical PSR, gender and treatment-by-baseline categorical PSR terms used as covariates.|
1659936|NCT01559259|3053506|Superiority or Other (legacy)||Least Square (LS) Mean difference|26.28|||<|0.001|2-Sided|95.0|20.33|32.22|||ANOVA|||Treatment difference and 95 percent (%) Confidence interval (CI) were based on Least square mean (LSM) from analysis of variance (ANOVA) with treatment, baseline categorical pain severity rating (PSR), gender and treatment-by-baseline categorical PSR terms used as covariates.|
1660037|NCT01558271|3053629|Superiority or Other||LS Mean Difference|-1.77||||0.553|2-Sided|95.0|-7.65|4.1||Treatment comparison for FBG at 52 weeks between LY2189265 and Liraglutide.|Mixed Models Analysis||||
1659937|NCT01559116|3053541|Superiority or Other||Mean Difference (Final Values)|0.142|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.087|0.196|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659938|NCT01559116|3053541|Superiority or Other||Mean Difference (Final Values)|0.161|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.107|0.216|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.||
1659939|NCT01559116|3053541|Superiority or Other||Mean Difference (Final Values)|0.149|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.095|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659940|NCT01559116|3053541|Superiority or Other||Mean Difference (Final Values)|0.452|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.398|0.507|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659941|NCT01559116|3053541|Superiority or Other||Mean Difference (Final Values)|0.151|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.098|0.205|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659942|NCT01559116|3053541|Superiority or Other||Mean Difference (Final Values)|0.159|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.105|0.212|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659943|NCT01559116|3053541|Superiority or Other||Mean Difference (Final Values)|0.462|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.408|0.516|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659944|NCT01559116|3053542|Superiority or Other||Mean Difference (Final Values)|0.099|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.043|0.154|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659945|NCT01559116|3053542|Superiority or Other||Mean Difference (Final Values)|0.166|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.111|0.222|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.||
1659946|NCT01559116|3053542|Superiority or Other||Mean Difference (Final Values)|0.147|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.092|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659947|NCT01559116|3053542|Superiority or Other||Median Difference (Final Values)|0.307|Standard Error of the Mean|0.029|<|0.0001|2-Sided|95.0|0.251|0.363|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659948|NCT01559116|3053542|Superiority or Other||Mean Difference (Final Values)|0.121|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.066|0.176|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659949|NCT01559116|3053542|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.115|0.225|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659950|NCT01559116|3053542|Superiority or Other||Mean Difference (Final Values)|0.329|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.274|0.385|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659951|NCT01559116|3053543|Superiority or Other||Mean Difference (Final Values)|0.121|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.072|0.17|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659952|NCT01559116|3053543|Superiority or Other||Mean Difference (Final Values)|0.148|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.099|0.197|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.||
1659953|NCT01559116|3053543|Superiority or Other||Mean Difference (Final Values)|0.166|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.117|0.214|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659954|NCT01559116|3053543|Superiority or Other||Mean Difference (Final Values)|0.351|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.301|0.4|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659955|NCT01559116|3053543|Superiority or Other||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.126|0.223|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659956|NCT01559116|3053543|Superiority or Other||Mean Difference (Final Values)|0.219|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.17|0.267|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659957|NCT01559116|3053543|Superiority or Other||Mean Difference (Final Values)|0.404|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.355|0.453|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1660092|NCT01557322|3053731|Superiority or Other|||||||0.3829|||||||Chi-squared|||Hospitalization Due to AE, Month 12: p-value was calculated using chi-square test.|
1659958|NCT01559116|3053544|Superiority or Other||Mean Difference (Final Values)|0.159|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.113|0.206|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659959|NCT01559116|3053544|Superiority or Other||Mean Difference (Final Values)|0.171|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.125|0.218|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.||
1659960|NCT01559116|3053544|Superiority or Other||Mean Difference (Final Values)|0.181|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.134|0.227|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659961|NCT01559116|3053544|Superiority or Other||Mean Difference (Final Values)|0.443|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.396|0.49|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659962|NCT01559116|3053544|Superiority or Other||Mean Difference (Final Values)|0.179|Standard Error of the Mean|0.023|<|0.0001|2-Sided|95.0|0.133|0.225|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659963|NCT01559116|3053544|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.023|<|0.0001|2-Sided|95.0|0.154|0.246|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659964|NCT01559116|3053544|Superiority or Other||Mean Difference (Final Values)|0.463|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.417|0.509|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to placebo is calculated.||
1659965|NCT01559116|3053545|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.096|0.184|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659966|NCT01559116|3053545|Superiority or Other||Mean Difference (Final Values)|0.159|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.115|0.203|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated. is calculated.||
1659967|NCT01559116|3053545|Superiority or Other||Mean Difference (Final Values)|0.173|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.129|0.217|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659968|NCT01559116|3053545|Superiority or Other||Mean Difference (Final Values)|0.396|Standard Error of the Mean|0.023|<|0.0001|2-Sided|95.0|0.352|0.441|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659969|NCT01559116|3053545|Superiority or Other||Mean Difference (Final Values)|0.177|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.133|0.221|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659970|NCT01559116|3053545|Superiority or Other||Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.166|0.253|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659971|NCT01559116|3053545|Superiority or Other||Mean Difference (Final Values)|0.433|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.389|0.477|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659972|NCT01559116|3053546|Superiority or Other||Mean Difference (Final Values)|0.122|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.089|0.155|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659973|NCT01559116|3053546|Superiority or Other||Mean Difference (Final Values)|0.132|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.099|0.165|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.||
1659974|NCT01559116|3053546|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.098|0.164|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659975|NCT01559116|3053546|Superiority or Other||Mean Difference (Final Values)|0.35|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.317|0.383|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659976|NCT01559116|3053546|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.078|0.143|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659977|NCT01559116|3053546|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.087|0.153|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659978|NCT01559116|3053546|Superiority or Other||Mean Difference (Final Values)|0.338|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.305|0.371|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1660093|NCT01557322|3053731|Superiority or Other|||||||0.7353|||||||Chi-squared|||Hospitalization Due to AE, Month 6: p-value was calculated using chi-square test.|
1659979|NCT01559116|3053547|Superiority or Other||Mean Difference (Final Values)|0.073|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.039|0.107|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659980|NCT01559116|3053547|Superiority or Other||Mean Difference (Final Values)|0.101|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.067|0.135|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.||
1659981|NCT01559116|3053547|Superiority or Other||Mean Difference (Final Values)|0.086|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.052|0.12|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659982|NCT01559116|3053547|Superiority or Other||Mean Difference (Final Values)|0.201|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.167|0.235|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659983|NCT01559116|3053547|Superiority or Other||Mean Difference (Final Values)|0.079|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.045|0.113|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659984|NCT01559116|3053547|Superiority or Other||Mean Difference (Final Values)|0.092|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.059|0.126|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659985|NCT01559116|3053547|Superiority or Other||Mean Difference (Final Values)|0.207|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.173|0.241|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659986|NCT01559116|3053548|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.061|0.121|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659987|NCT01559116|3053548|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.08|0.14|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.||
1659988|NCT01559116|3053548|Superiority or Other||Mean Difference (Final Values)|0.093|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.063|0.123|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659989|NCT01559116|3053548|Superiority or Other||Mean Difference (Final Values)|0.232|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.201|0.262|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659990|NCT01559116|3053548|Superiority or Other||Median Difference (Final Values)|0.102|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.072|0.132|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659991|NCT01559116|3053548|Superiority or Other||Median Difference (Final Values)|0.103|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.074|0.133|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659992|NCT01559116|3053548|Superiority or Other||Mean Difference (Final Values)|0.243|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.212|0.273|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659993|NCT01559116|3053549|Superiority or Other||Mean Difference (Final Values)|0.124|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.093|0.154|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659994|NCT01559116|3053549|Superiority or Other||Mean Difference (Final Values)|0.139|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.109|0.169|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.||
1659995|NCT01559116|3053549|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.101|0.161|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659996|NCT01559116|3053549|Superiority or Other||Mean Difference (Final Values)|0.323|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.293|0.354|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1659997|NCT01559116|3053549|Superiority or Other||Mean Difference (Final Values)|0.119|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.089|0.149|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1659998|NCT01559116|3053549|Superiority or Other||Mean Difference (Final Values)|0.126|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.096|0.156|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1659999|NCT01559116|3053549|Superiority or Other||Mean Difference (Final Values)|0.319|Standard Error of the Mean|0.015|<|0.0001||95.0|0.289|0.349|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1660094|NCT01557322|3053731|Superiority or Other|||||||0.963|||||||Chi-squared|||Death Due to AE, Month 60: p-value was calculated using chi-square test.|
1660000|NCT01559116|3053550|Superiority or Other||Median Difference (Final Values)|0.107|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.079|0.136|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1660001|NCT01559116|3053550|Superiority or Other||Mean Difference (Final Values)|0.124|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.096|0.152|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium low dose (2.5 µg) is calculated.||
1660002|NCT01559116|3053550|Superiority or Other||Median Difference (Final Values)|0.111|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.083|0.14|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1660003|NCT01559116|3053550|Superiority or Other||Mean Difference (Final Values)|0.277|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.249|0.306|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to placebo is calculated.||
1660004|NCT01559116|3053550|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.082|0.139|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Tiotropium high dose (5 µg) is calculated.||
1660005|NCT01559116|3053550|Superiority or Other||Mean Difference (Final Values)|0.115|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.087|0.143|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Olodaterol (5 µg) is calculated.||
1660006|NCT01559116|3053550|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.252|0.309|||Mixed Models Analysis|Mixed effect model repeated measures (MMRM) with fixed effects for treatment,period and random effect for patient.|Adjusted mean difference to Placebo is calculated.||
1660007|NCT01559012|3053556|Superiority or Other||Mean Difference (Final Values)|3.0||||0.055|2-Sided|95.0|0.3|6.3|||Wilcoxon (Mann-Whitney)||||
1660008|NCT01559012|3053557|Superiority or Other||Mean Difference (Final Values)|6.0||||0.01|2-Sided|95.0|0.9|10.9|||Wilcoxon (Mann-Whitney)||||
1660009|NCT01559012|3053560|Superiority or Other||proportion|0.0||||0.0089|2-Sided|95.0|||||Fisher Exact||||
1660010|NCT01559012|3053561|Superiority or Other||days off-therapy %|29.0||||0.051|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)|||Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P < 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .|
1660011|NCT01559012|3053562|Superiority or Other||mean values|0.8||||0.013|2-Sided|95.0|0.13|1.57|||Wilcoxon (Mann-Whitney)|||Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P < 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .|
1660012|NCT01559012|3053563|Superiority or Other||difference of percentage of positivity|0.3||||0|2-Sided|95.0|0.04|0.47|||Wilcoxon (Mann-Whitney)|||"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"|
1660013|NCT01559012|3053564|Non-Inferiority or Equivalence|A sample size modeling for crossover studies (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P < 0.01|within patient variation|7.5|||<|0.01|2-Sided|95.0|2.17|12.83|||Wilcoxon (Mann-Whitney)|||Analysis within-patient. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P < 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD.|
1660014|NCT01559012|3053564|Superiority or Other||Mean Difference (Final Values)|7.0|||<|0.009|2-Sided|95.0|1.78|11.5|||Wilcoxon (Mann-Whitney)|||Analysis within groups clonidine versus placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P < 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD. .|
1660015|NCT01559012|3053565|Non-Inferiority or Equivalence|A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P < 0.01|within patient variation|1.83|||<|0.02|2-Sided|95.0|0.43|3.24|||Wilcoxon (Mann-Whitney)|||This is a within patient variation between clonidine and placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P < 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean +/- Standard Deviation (SD).|
1660016|NCT01559012|3053565|Superiority or Other||Mean Difference (Final Values)|2.2|Standard Deviation|2.7|<|0.001|2-Sided|95.0|1.05|3.32||A sample size modeling (MGH Mallinckrodt General Clinical Research Center) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P < 0.01 and a beta > 0.90.|Wilcoxon (Mann-Whitney)|Statistical signiﬁcance was assessed by the use of Mann-Whitney U test. P < 0.05 was deﬁned as statistically signiﬁcant||This is an analysis between groups of intervention clonidine versus placebo. Statistical signiﬁcance was assessed by the use of Mann-Whitney U test P < 0.05 was deﬁned as statistically signiﬁcant . Data are presented as mean + SD.|
1660017|NCT01558674|3053592|Superiority or Other||Geometric Mean Ratio (GMR)|1.1|||||2-Sided|90.0|0.99|1.22|||||GMR = Geometric mean (GM) MK-7145 8 mg divided by GM Furosemide||
1660018|NCT01558674|3053594|Superiority or Other||Difference in Least Squares (LS) Means|-98.5|||||2-Sided|95.0|-138.0|-59.1|||||8-mg MK-7145 LS Mean minus Furosemide LS Mean||
1660019|NCT01558271|3053624|Superiority or Other||||||>|0.999||||||Treatment comparison at 52 weeks between LY2189265 and Liraglutide.|Fisher Exact||||
1660020|NCT01558271|3053624|Superiority or Other||||||>|0.999||||||Treatment comparison at 26 weeks between LY2189265 and Liraglutide.|Fisher Exact||||
1660021|NCT01558271|3053624|Superiority or Other||||||>|0.999||||||Treatment comparison at 26 weeks between LY2189265 and placebo.|Fisher Exact||||
1660022|NCT01558271|3053625|Superiority or Other||LS Mean Difference|0.73||||0.753|2-Sided|95.0|-3.83|5.29||Treatment comparison for HOMA2-%B based on fasting C-peptide at 52 weeks between LY2189265 and Liraglutide.|ANCOVA||||
1660023|NCT01558271|3053625|Superiority or Other||LS Mean Difference|1.91||||0.417|2-Sided|95.0|-2.72|6.54||Treatment comparison for HOMA2-%B based on fasting insulin at 52 weeks between LY2189265 and Liraglutide.|ANCOVA||||
1660039|NCT01558271|3053629|Superiority or Other||LS Mean Difference|-40.21|||<|0.001|2-Sided|95.0|-47.31|-33.11||Treatment comparison for FBG at 26 weeks between LY2189265 and placebo.|Mixed Models Analysis||||
1660040|NCT01558271|3053630|Superiority or Other|||||||0.103||||||Treatment comparison for HbA1c <=6.5% at 52 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (<25 / >=25 kg/m^2), and baseline HbA1c group.|||
1660041|NCT01558271|3053630|Superiority or Other|||||||0.112||||||Treatment comparison for HbA1c <7% at 52 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (<25 / >=25 kg/m^2), and baseline HbA1c group.|||
1660042|NCT01558271|3053630|Superiority or Other|||||||0.844||||||Treatment comparison for HbA1c <=6.5% at 26 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (<25 / >=25 kg/m^2), and baseline HbA1c group.|||
1660043|NCT01558271|3053630|Superiority or Other||||||<|0.001||||||Treatment comparison for HbA1c <=6.5% at 26 weeks between LY2189265 and placebo.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (<25 / >=25 kg/m^2), and baseline HbA1c group.|||
1660044|NCT01558271|3053630|Superiority or Other||||||<|0.608||||||Treatment comparison for HbA1c <7% at 26 weeks between LY2189265 and Liraglutide.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (<25 / >=25 kg/m^2), and baseline HbA1c group.|||
1660045|NCT01558271|3053630|Superiority or Other||||||<|0.001||||||Treatment comparison for HbA1c <7% at 26 weeks between LY2189265 and placebo.|Cochran-Mantel-Haenszel|Pairwise comparison was adjusted for prestudy therapy (OAM yes/no), baseline BMI group (<25 / >=25 kg/m^2), and baseline HbA1c group.|||
1660046|NCT01558271|3053631|Superiority or Other||LS Mean Difference|-0.2||||0.04|2-Sided|95.0|-0.39|-0.01|||Mixed Models Analysis||||
1660047|NCT01558271|3053632|Non-Inferiority or Equivalence|If the upper limit of the 95% Confidence Interval (CI) was <0.4%, then LY2189265 was declared non-inferior to Liraglutide. If the upper limit of the 95% CI was <0.0%, then LY2189265 was declared superior to liraglutide.|LS Mean Difference|-0.1||||0.248|2-Sided|95.0|-0.27|0.07|||Mixed Models Analysis|||Approximately 490 participants were to be randomized in a 4:1:2 ratio to LY2189265, placebo, or Liraglutide, respectively. This sample size would provide >90% power to confirm non-inferiority of LY2189265 to liraglutide by a margin of 0.4%. This computation assumed a true mean difference in HbA1c change from baseline between LY2189265 and Liraglutide being 0%, a common standard deviation of 1.1%, a 1-sided significance level of 0.025, and a 9% drop-out rate between randomization and Week 26.|
1660048|NCT01558271|3053632|Superiority or Other||LS Mean Difference|-1.57|||<|0.001|2-Sided|95.0|-1.79|-1.35|||Mixed Models Analysis|||Approximately 490 participants were to be randomized in a 4:1:2 ratio to LY2189265, placebo, or Liraglutide, respectively. This sample size would provide greater than 99% power to demonstrate superiority of LY2189265 to placebo. This computation assumed a true mean difference in HbA1c change from baseline between LY2189265 and placebo being 0.8%, a common standard deviation of 1.1%, a 1-sided significance level of 0.025, and a 9% drop-out rate between randomization and Week 26.|
1660049|NCT01557920|3053650|Superiority or Other||||||<|0.001||||||The number of swallows per hour: 1.7±3.3 during anesthesia vs. 28.0±22.3 during wakefulness|Mixed Models Analysis||||
1660050|NCT01557920|3053655|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Comparison of pathological swallow-rate increase by carbon-dioxide during anesthesia and wakefulness|
1660051|NCT01557920|3053655|Superiority or Other||||||<|0.001||||||pathological swallows under anesthesia vs. wakefulness: 25.9% vs. 4.9%|Mixed Models Analysis||||
1660052|NCT01557894|3053657|Superiority or Other||||||<|0.01|||||||ANCOVA||||
1660053|NCT01557894|3053658|Superiority or Other||||||<|0.01|||||||ANCOVA||||
1660054|NCT01557894|3053659|Superiority or Other||||||<|0.01|||||||ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor.|||
1660055|NCT01557894|3053660|Superiority or Other||||||<|0.01||||||The a priori threshold for statistical significance was set at .05|ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor|||
1660056|NCT01557894|3053661|Superiority or Other||||||<|0.01||||||The a priori threshold for statistical significance was set at .05|ANCOVA|Changes in primary outcome measures were evaluated using univariate ANCOVA, with pre-intervention scores as covariates, and group as a fixed factor|||
1660057|NCT01557582|3053683|Superiority or Other||EF percent difference|2.03|||||2-Sided|95.0|0.72|3.33|||||Mean percent difference and 95% CI for EF||
1660058|NCT01557582|3053683|Superiority or Other||ESV percent difference|1.76|||||2-Sided|95.0|-1.17|4.76|||||Mean percent difference and 95% CI for ESV||
1660059|NCT01557582|3053683|Superiority or Other||EDV percent difference|4.8|||||2-Sided|95.0|2.24|7.56|||||Mean percent difference and 95% CI for EDV||
1660060|NCT01557569|3053684|Superiority or Other||Median Difference (Final Values)|0.413|||<|0.05|2-Sided||||||Kruskal-Wallis|||Due to skewed data, Kruskal Wallis Test was used.|
1660061|NCT01557348|3053716|Superiority or Other|||||||0.3535||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in duration of morning stiffness at month 12|
1660062|NCT01557348|3053716|Superiority or Other|||||||0.3253||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in duration of morning stiffness at month 6|
1660063|NCT01557348|3053717|Superiority or Other|||||||0.1515||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in HAQ-DI at Month 12|
1660064|NCT01557348|3053717|Superiority or Other|||||||0.337||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in HAQ-DI at Month 6|
1660254|NCT01554241|3054005|Superiority or Other||||||<|0.0009|||||||ANOVA|Bonferroni/Dunn adjustment|||
1660065|NCT01557348|3053718|Superiority or Other|||||||0.0295||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Participant's Visual Analogue Scale Pain Score at Months 12|
1660066|NCT01557348|3053718|Superiority or Other|||||||0.2026||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Participant's Visual Analogue Scale Pain Score at Months 6|
1660067|NCT01557348|3053719|Superiority or Other|||||||0.4802||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Patient Global Assessment of Disease at Month 12|
1660068|NCT01557348|3053719|Superiority or Other|||||||0.0443||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Patient Global Assessment of Disease at Month 6|
1660069|NCT01557348|3053720|Superiority or Other|||||||0.0587||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Physician Global Assessment of Disease at Month 12|
1660070|NCT01557348|3053720|Superiority or Other|||||||0.0764||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in Physician Global Assessment of Disease at Month 6|
1660071|NCT01557348|3053721|Superiority or Other|||||||0.2918||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in ESR at Month 12|
1660072|NCT01557348|3053721|Superiority or Other|||||||0.0086||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in ESR at Month 6|
1660073|NCT01557348|3053722|Superiority or Other|||||||0.4849||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in CRP at Month 12|
1660074|NCT01557348|3053722|Superiority or Other|||||||0.8758||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in CRP at Month 6|
1660075|NCT01557348|3053723|Superiority or Other|||||||0.5867||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in SJC at Month 12|
1660076|NCT01557348|3053723|Superiority or Other|||||||0.4168||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in SJC at Month 6|
1660077|NCT01557348|3053724|Superiority or Other|||||||0.2342||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in TJC at Month 12|
1660078|NCT01557348|3053724|Superiority or Other|||||||0.1126||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA|||Comparison of least squares mean change from Baseline in TJC at Month 6|
1660079|NCT01557348|3053725|Superiority or Other|||||||0.0588||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA||||
1660080|NCT01557348|3053726|Superiority or Other|||||||0.0068||||||LsMean and p-value are based on an ANCOVA model adjusted for significant factors leading to selection of new biologic therapy and unbalanced baseline covariates.|ANCOVA||||
1660081|NCT01557322|3053728|Superiority or Other|||||||0.8379|||||||Regression, Linear|||Vitality Score: p-value was calculated using multivariate linear regression with baseline vitality score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.|
1660082|NCT01557322|3053728|Superiority or Other|||||||0.4908|||||||Regression, Linear|||MCS: p-value was calculated using multivariate linear regression with baseline MCS and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.|
1660083|NCT01557322|3053728|Superiority or Other|||||||0.2558|||||||Regression, Linear|||PCS: p-value was calculated using multivariate linear regression with baseline PCS and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.|
1660084|NCT01557322|3053729|Superiority or Other||||||<|0.0001|||||||Regression, Linear|||P-value was calculated using multivariate linear regression with baseline HAQ-DI score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.|
1660085|NCT01557322|3053730|Superiority or Other||||||<|0.0001|||||||Regression, Linear|||P-value was calculated using multivariate linear regression with baseline DAS28 score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.|
1660086|NCT01557322|3053731|Superiority or Other|||||||0.5491|||||||Chi-squared|||Hospitalization Due to AE, Month 60: p-value was calculated using chi-square test.|
1660087|NCT01557322|3053731|Superiority or Other|||||||0.6356|||||||Chi-squared|||Hospitalization Due to AE, Month 48: p-value was calculated using chi-square test.|
1660088|NCT01557322|3053731|Superiority or Other|||||||0.4124|||||||Chi-squared|||Hospitalization Due to AE, Month 36: p-value was calculated using chi-square test.|
1660089|NCT01557322|3053731|Superiority or Other|||||||0.1218|||||||Chi-squared|||Hospitalization Due to AE, Month 30: p-value was calculated using chi-square test.|
1660095|NCT01557322|3053731|Superiority or Other|||||||0.7137|||||||Chi-squared|||Death Due to AE, Month 36: p-value was calculated using chi-square test.|
1660096|NCT01557322|3053731|Superiority or Other|||||||0.0034|||||||Chi-squared|||Death Due to AE, Month 24: p-value was calculated using chi-square test.|
1660097|NCT01557322|3053731|Superiority or Other|||||||0.5642|||||||Chi-squared|||Death Due to AE, Month 18: p-value was calculated using chi-square test.|
1660098|NCT01557322|3053731|Superiority or Other|||||||0.2595|||||||Chi-squared|||Death Due to AE, Month 12: p-value was calculated using chi-square test.|
1660099|NCT01557322|3053731|Superiority or Other|||||||0.5817|||||||Chi-squared|||Death Due to AE, Month 6: p-value was calculated using chi-square test.|
1660100|NCT01557322|3053732|Superiority or Other|||||||0.427|||||||Chi-squared|||Solid Tumor, Month 60: p-value was calculated using chi-square test.|
1660101|NCT01557322|3053732|Superiority or Other|||||||0.187|||||||Chi-squared|||Solid Tumor, Month 48: p-value was calculated using chi-square test.|
1660102|NCT01557322|3053732|Superiority or Other|||||||0.3488|||||||Chi-squared|||Solid Tumor, Month 36: p-value was calculated using chi-square test.|
1660103|NCT01557322|3053732|Superiority or Other|||||||0.1134|||||||Chi-squared|||Solid Tumor, Month 30: p-value was calculated using chi-square test.|
1660104|NCT01557322|3053732|Superiority or Other|||||||0.5003|||||||Chi-squared|||Solid Tumor, Month 24: p-value was calculated using chi-square test.|
1660105|NCT01557322|3053732|Superiority or Other|||||||0.3224|||||||Chi-squared|||Solid Tumor, Month 18: p-value was calculated using chi-square test.|
1660106|NCT01557322|3053732|Superiority or Other|||||||0.4818|||||||Chi-squared|||Solid Tumor, Month 12: p-value was calculated using chi-square test.|
1660107|NCT01557322|3053732|Superiority or Other|||||||0.4932|||||||Chi-squared|||Solid Tumor, Month 6: p-value was calculated using chi-square test.|
1660108|NCT01557322|3053732|Superiority or Other|||||||0.3581|||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 48: p-value was calculated using chi-square test.|
1660109|NCT01557322|3053732|Superiority or Other|||||||0.5404|||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 36: p-value was calculated using chi-square test.|
1660110|NCT01557322|3053732|Superiority or Other|||||||0.4955|||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 30: p-value was calculated using chi-square test.|
1660111|NCT01557322|3053732|Superiority or Other|||||||0.9855|||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 24: p-value was calculated using chi-square test.|
1660112|NCT01557322|3053732|Superiority or Other|||||||0.5102|||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 18: p-value was calculated using chi-square test.|
1660113|NCT01557322|3053732|Superiority or Other|||||||0.3886|||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 12: p-value was calculated using chi-square test.|
1660114|NCT01557322|3053732|Superiority or Other|||||||0.4175|||||||Chi-squared|||Non-Melanoma Skin Cancer, Month 6: p-value was calculated using chi-square test.|
1660115|NCT01557322|3053732|Superiority or Other|||||||0.0044|||||||Chi-squared|||Leukaemia, Month 12: p-value was calculated using chi-square test.|
1660116|NCT01557322|3053732|Superiority or Other|||||||0.7336|||||||Chi-squared|||Myeloma, Month 30: p-value was calculated using chi-square test.|
1660117|NCT01557322|3053732|Superiority or Other|||||||0.7253|||||||Chi-squared|||Myeloma, Month 12: p-value was calculated using chi-square test.|
1660118|NCT01557322|3053732|Superiority or Other|||||||0.0075|||||||Chi-squared|||Hodgkins Lymphoma, Month 48: p-value was calculated using chi-square test.|
1660119|NCT01557322|3053732|Superiority or Other|||||||0.0793|||||||Chi-squared|||Hodgkins Lymphoma, Month 36: p-value was calculated using chi-square test.|
1660120|NCT01557322|3053732|Superiority or Other|||||||0.6301|||||||Chi-squared|||Hodgkins Lymphoma, Month 30: p-value was calculated using chi-square test.|
1660121|NCT01557322|3053732|Superiority or Other|||||||0.0024|||||||Chi-squared|||Hodgkins Lymphoma, Month 18: p-value was calculated using chi-square test.|
1660122|NCT01557322|3053732|Superiority or Other|||||||0.0895|||||||Chi-squared|||Hodgkins Lymphoma, Month 6: p-value was calculated using chi-square test.|
1660123|NCT01557322|3053732|Superiority or Other|||||||0.0075|||||||Chi-squared|||Lymphoproliferative Tumors, Month 48: p-value was calculated using chi-square test.|
1660124|NCT01557322|3053732|Superiority or Other|||||||0.0793|||||||Chi-squared|||Lymphoproliferative Tumors, Month 36: p-value was calculated using chi-square test.|
1660125|NCT01557322|3053732|Superiority or Other|||||||0.5552|||||||Chi-squared|||Lymphoproliferative Tumors, Month 30: p-value was calculated using chi-square test.|
1660126|NCT01557322|3053732|Superiority or Other|||||||0.0024|||||||Chi-squared|||Lymphoproliferative Tumors, Month 18: p-value was calculated using chi-square test.|
1660127|NCT01557322|3053732|Superiority or Other|||||||0.0774|||||||Chi-squared|||Lymphoproliferative Tumors, Month 12: p-value was calculated using chi-square test.|
1660128|NCT01557322|3053732|Superiority or Other|||||||0.0895|||||||Chi-squared|||Lymphoproliferative Tumors, Month 6: p-value was calculated using chi-square test.|
1660129|NCT01557322|3053733|Superiority or Other|||||||0.4804|||||||Chi-squared|||Month 60: p-value was calculated using chi-square test.|
1660130|NCT01557322|3053733|Superiority or Other|||||||0.0472|||||||Chi-squared|||Month 48: p-value was calculated using chi-square test.|
1660131|NCT01557322|3053733|Superiority or Other|||||||0.1085|||||||Chi-squared|||Month 36: p-value was calculated using chi-square test.|
1660132|NCT01557322|3053733|Superiority or Other|||||||0.3829|||||||Chi-squared|||Month 30: p-value was calculated using chi-square test.|
1660133|NCT01557322|3053733|Superiority or Other|||||||0.6495|||||||Chi-squared|||Month 24: p-value was calculated using chi-square test.|
1660134|NCT01557322|3053733|Superiority or Other|||||||0.999|||||||Chi-squared|||Month 18: p-value was calculated using chi-square test.|
1660135|NCT01557322|3053733|Superiority or Other|||||||0.5103|||||||Chi-squared|||Month 12: p-value was calculated using chi-square test.|
1660136|NCT01557322|3053733|Superiority or Other|||||||0.0233|||||||Chi-squared|||Month 6: p-value was calculated using chi-square test.|
1660137|NCT01557322|3053743|Superiority or Other|||||||0.68|||||||t-test, 2 sided|||Baseline Vitality Score: p-value was calculated using 2-sided t-test.|
1660138|NCT01557322|3053743|Superiority or Other|||||||0.886|||||||t-test, 2 sided|||Baseline MCS: p-value was calculated using 2-sided t-test.|
1660139|NCT01557322|3053743|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline PCS: p-value was calculated using 2-sided t-test.|
1660140|NCT01557322|3053744|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.|
1660141|NCT01557322|3053745|Superiority or Other||||||<|0.001|||||||Chi-squared|||Previous DMARDs, Leflunomide: p-value was calculated using chi-square test.|
1660142|NCT01557322|3053745|Superiority or Other||||||<|0.001|||||||Chi-squared|||Previous DMARDs, Cyclosporine: p-value was calculated using chi-square test.|
1660143|NCT01557322|3053745|Superiority or Other||||||<|0.001|||||||Chi-squared|||Previous DMARDs, Cyclophosphamide: p-value was calculated using chi-square test.|
1660144|NCT01557322|3053745|Superiority or Other||||||<|0.001|||||||Chi-squared|||Previous DMARDs, Azathioprine: p-value was calculated using chi-square test.|
1660145|NCT01557322|3053745|Superiority or Other||||||<|0.001|||||||Chi-squared|||Previous DMARDs, Methotrexate: p-value was calculated using chi-square test.|
1660146|NCT01557322|3053745|Superiority or Other||||||<|0.001|||||||Chi-squared|||Current DMARDs, Sulphasalazine: p-value was calculated using chi-square test.|
1660147|NCT01557322|3053745|Superiority or Other||||||<|0.099|||||||Chi-squared|||Current DMARDs, Leflunomide: p-value was calculated using chi-square test.|
1660148|NCT01557322|3053745|Superiority or Other||||||<|0.066|||||||Chi-squared|||Current DMARDs, Cyclosporine: p-value was calculated using chi-square test.|
1660149|NCT01557322|3053745|Superiority or Other||||||<|1|||||||Chi-squared|||Current DMARDs, Cyclophosphamide: p-value was calculated using chi-square test.|
1660150|NCT01557322|3053745|Superiority or Other||||||<|0.313|||||||Chi-squared|||Current DMARDs, Azathioprine: p-value was calculated using chi-square test.|
1660151|NCT01557322|3053745|Superiority or Other||||||<|0.001|||||||Chi-squared|||Current DMARDs, Methotrexate: p-value was calculated using chi-square test.|
1660152|NCT01557322|3053747|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.|
1660153|NCT01557322|3053748|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.|
1660154|NCT01557322|3053749|Superiority or Other|||||||0.199|||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.|
1660155|NCT01557322|3053750|Superiority or Other|||||||0.108|||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.|
1660156|NCT01557322|3053751|Superiority or Other|||||||0.154|||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.|
1660157|NCT01557322|3053752|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.|
1660158|NCT01557322|3053753|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.|
1660159|NCT01557322|3053754|Superiority or Other|||||||0.3746|||||||Regression, Linear|||Change at Month 60: p-value was calculated using multivariate linear regression with baseline DAS28 score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.|
1660160|NCT01557322|3053754|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline: p-value was calculated using 2-sided t-test.|
1660161|NCT01557322|3053755|Superiority or Other|||||||0.369|||||||t-test, 2 sided|||Diastolic Blood Pressure: p-value was calculated using 2-sided t-test.|
1660162|NCT01557322|3053755|Superiority or Other|||||||0.016|||||||t-test, 2 sided|||Systolic Blood Pressure: p-value was calculated using 2-sided t-test.|
1660163|NCT01557322|3053756|Superiority or Other|||||||0.188|||||||t-test, 2 sided|||P-value was calculated using 2-sided t-test.|
1660164|NCT01557322|3053757|Superiority or Other|||||||0.033|||||||Chi-squared|||Cancer: p-value was calculated using chi-square test.|
1660165|NCT01557322|3053757|Superiority or Other|||||||0.308|||||||Chi-squared|||Depression: p-value was calculated using chi-square test.|
1660166|NCT01557322|3053757|Superiority or Other|||||||0.048|||||||Chi-squared|||Hyperthyroidism: p-value was calculated using chi-square test.|
1660167|NCT01557322|3053757|Superiority or Other|||||||0.385|||||||Chi-squared|||Diabetes: p-value was calculated using chi-square test.|
1660168|NCT01557322|3053757|Superiority or Other|||||||1|||||||Chi-squared|||Demyelination: p-value was calculated using chi-square test.|
1660169|NCT01557322|3053757|Superiority or Other|||||||0.802|||||||Chi-squared|||Tuberculosis: p-value was calculated using chi-square test.|
1660170|NCT01557322|3053757|Superiority or Other|||||||0.526|||||||Chi-squared|||Renal Disease: p-value was calculated using chi-square test.|
1660171|NCT01557322|3053757|Superiority or Other|||||||0.003|||||||Chi-squared|||Liver Disease: p-value was calculated using chi-square test.|
1660172|NCT01557322|3053757|Superiority or Other|||||||0.566|||||||Chi-squared|||Peptic Ulcer: p-value was calculated using chi-square test.|
1660173|NCT01557322|3053757|Superiority or Other|||||||0.027|||||||Chi-squared|||Chronic Bronchitis/Emphysema: p-value was calculated using chi-square test.|
1660174|NCT01557322|3053757|Superiority or Other|||||||0.542|||||||Chi-squared|||Asthma: p-value was calculated using chi-square test.|
1660175|NCT01557322|3053757|Superiority or Other|||||||1|||||||Chi-squared|||Epilepsy: p-value was calculated using chi-square test.|
1660176|NCT01557322|3053757|Superiority or Other|||||||0.117|||||||Chi-squared|||Stroke: p-value was calculated using chi-square test.|
1660177|NCT01557322|3053757|Superiority or Other|||||||0.215|||||||Chi-squared|||Heart Attack: p-value was calculated using chi-square test.|
1660178|NCT01557322|3053757|Superiority or Other|||||||0.006|||||||Chi-squared|||Angina: p-value was calculated using chi-square test.|
1660179|NCT01557322|3053757|Superiority or Other|||||||0.381|||||||Chi-squared|||High Blood Pressure: p-value was calculated using chi-square test.|
1660180|NCT01557322|3053758|Superiority or Other||||||<|0.001|||||||Chi-squared|||P-value was calculated using chi-square test.|
1660181|NCT01557322|3053759|Superiority or Other||||||<|0.001|||||||Chi-squared|||Neck Surgery: p-value was calculated using chi-square test.|
1660182|NCT01557322|3053759|Superiority or Other||||||<|0.001|||||||Chi-squared|||Wrist/Hand/Ankle/Foot Surgery: p-value was calculated using chi-square test.|
1660183|NCT01557322|3053759|Superiority or Other||||||<|0.001|||||||Chi-squared|||Total Elbow Replacement: p-value was calculated using chi-square test.|
1660184|NCT01557322|3053759|Superiority or Other||||||<|0.001|||||||Chi-squared|||Total Shoulder Replacement: p-value was calculated using chi-square test.|
1660185|NCT01557322|3053759|Superiority or Other||||||<|0.001|||||||Chi-squared|||Total Hip Replacement: p-value was calculated using chi-square test.|
1660186|NCT01557322|3053759|Superiority or Other||||||<|0.001|||||||Chi-squared|||Total Knee Replacement: p-value was calculated using chi-square test.|
1660187|NCT01557322|3053760|Superiority or Other|||||||0.62|||||||Chi-squared|||Other: p-value was calculated using chi-square test.|
1660188|NCT01557322|3053760|Superiority or Other|||||||0.22|||||||Chi-squared|||Pulmonary Fibrosis: p-value was calculated using chi-square test.|
1660189|NCT01557322|3053760|Superiority or Other|||||||0.725|||||||Chi-squared|||Nailfold Vasculitis: p-value was calculated using chi-square test.|
1660190|NCT01557322|3053760|Superiority or Other|||||||0.026|||||||Chi-squared|||Systemic Vasculitis: p-value was calculated using chi-square test.|
1660191|NCT01557322|3053760|Superiority or Other|||||||0.257|||||||Chi-squared|||Eye Involvement: p-value was calculated using chi-square test.|
1660192|NCT01557322|3053760|Superiority or Other|||||||0.024|||||||Chi-squared|||Serosal Involvement: p-value was calculated using chi-square test.|
1660193|NCT01557322|3053760|Superiority or Other||||||<|0.001|||||||Chi-squared|||Sicca Syndrome: p-value was calculated using chi-square test.|
1660194|NCT01557322|3053761|Superiority or Other|||||||0.038|||||||Chi-squared|||Erosions on Hand or Feet X-Ray: p-value was calculated using chi-square test.|
1660195|NCT01557322|3053761|Superiority or Other|||||||0.605|||||||Chi-squared|||Rheumatoid Factor Positive: p-value was calculated using chi-square test.|
1660196|NCT01557322|3053761|Superiority or Other||||||<|0.001|||||||Chi-squared|||Nodules: p-value was calculated using chi-square test.|
1660197|NCT01557322|3053761|Superiority or Other||||||<|0.001|||||||Chi-squared|||Symmetry: p-value was calculated using chi-square test.|
1660198|NCT01557322|3053761|Superiority or Other||||||<|0.363|||||||Chi-squared|||Arthritis/Deformity of Hand/Joint: p-value was calculated using chi-square test.|
1660199|NCT01557322|3053761|Superiority or Other||||||<|0.001|||||||Chi-squared|||Arthritis or Deformity of 3 or More Joint Areas: p-value was calculated using chi-square test.|
1660200|NCT01557322|3053761|Superiority or Other||||||<|0.01|||||||Chi-squared|||Morning Stiffness > 1 Hour: p-value was calculated using chi-square test.|
1660201|NCT01557166|3053772|Superiority or Other||Estimated treatment difference|-6.1||||0.015||95.0|-11.0|-1.19|||ANCOVA|ANCOVA model was used with treatment, country and sex as fixed factors, and the baseline value of AHI, baseline BMI and baseline age as covariates.||Let μ liraglutide 3.0mg and μ placebo denote mean change in AHI for liraglutide 3.0 mg and placebo,respectively. The null-hypothesis and the alternative was H0: μliraglutide 3.0mg = μplacebo against the alternative HA: μliraglutide 3.0mg ≠ μplacebo.|
1660202|NCT01556997|3053773|Superiority or Other|||||||0.025||||||The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.|ANCOVA||||
1660203|NCT01556997|3053774|Superiority or Other|||||||0.025||||||The statistical model was an analysis of covariance model with treatment as the main effect and baseline DBP (<100 mmHg versus ≥100 mmHg), current type 2 diabetes status (yes versus no), and race (black versus non-black) as covariates.|ANCOVA||||
1660204|NCT01556932|3053775|Superiority or Other||Mean Difference (Final Values)|0.8|Standard Deviation|3.2541|||2-Sided||||||||||
1660205|NCT01556763|3053791|Superiority or Other||||||=|0|||||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.|
1660206|NCT01556763|3053792|Superiority or Other||||||=|0|||||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.|
1660207|NCT01556763|3053793|Superiority or Other||||||=|0|||||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.|
1660208|NCT01556763|3053794|Superiority or Other||||||=|0|||||||ANCOVA|||Baseline value was the covariate and all values obtained during the treatment period were averaged together. This value was adjusted by regression against the baseline and estimation of a new value as if all subjects possessed the same baseline.|
1660209|NCT01556425|3053840|Superiority||Odds Ratio (OR)|4.46||||0.09|2-Sided|95.0|0.8|26.1|||General Estimating Equation (GEE)||||
1660210|NCT01556425|3053840|Superiority||Odds Ratio (OR)|2.47||||0.34|2-Sided|95.0|0.4|15.8|||General Estimating Equation (GEE)||||
1660211|NCT01556425|3053840|Superiority||Odds Ratio (OR)|0.91||||0.91|2-Sided|95.0|0.1|5.8|||General Estimating Equation (GEE)||||
1660212|NCT01556425|3053840|Superiority||Odds Ratio (OR)|0.2||||0.08|2-Sided|95.0|0.03|1.2|||General Estimating Equation (GEE)||||
1660213|NCT01556425|3053840|Superiority||Odds Ratio (OR)|0.36||||0.3|2-Sided|95.0|0.1|2.4|||General Estimating Equation (GEE)||||
1660214|NCT01556425|3053841|Superiority||Odds Ratio (OR)|10.4||||0.03|2-Sided|95.0|1.3|85.5|||General Estimating Equation (GEE)||||
1660215|NCT01556425|3053841|Superiority||Odds Ratio (OR)|2.66||||0.39|2-Sided|95.0|0.3|24.9|||General Estimating Equation (GEE)||||
1660216|NCT01556425|3053841|Superiority||Odds Ratio (OR)|6.0||||0.11|2-Sided|95.0|0.7|54.9|||General Estimating Equation (GEE)||||
1660217|NCT01556425|3053841|Superiority||Odds Ratio (OR)|0.58||||0.61|2-Sided|95.0|0.1|4.6|||General Estimating Equation (GEE)||||
1660218|NCT01556425|3053841|Superiority||Odds Ratio (OR)|2.26||||0.48|2-Sided|95.0|0.2|21.6|||General Estimating Equation (GEE)||||
1660219|NCT01556204|3053858|Superiority or Other|||||||0.48||||||This applies to Row title: 6-months|Mixed Models Analysis|||Pain scores at 6 months for robotic vs laparoscopy.|
1660220|NCT01556204|3053858|Superiority or Other|||||||0.53||||||This applies to Row title: 6-weeks|Mixed Models Analysis|||Pain scores at 6 weeks comparison between robotic and laparoscopy.|
1660221|NCT01556204|3053858|Superiority or Other|||||||0.53||||||This applies to Row title: Baseline|Mixed Models Analysis|||Secondary analysis for pain at baseline for robotic vs conventional laparoscopy for endometriosis.|
1660222|NCT01556204|3053859|Superiority or Other|||||||0.71||||||This p-value is from a single comparison between two arms for operative time.|t-test, 2 sided|||Variance estimates for this power analysis were taken from Nezhat C, et al, 2010. We determined that 37 subjects in each arm were needed to detect a difference of ≥ 32 minutes in operating time between conventional and robotic surgery for endometriosis with 80% power and a significance level of 0.05.|
1660223|NCT01556165|3053862|Superiority or Other||Mean Difference (Final Values)|-1.71|Standard Error of the Mean|0.91||0.0641|2-Sided|95.0|-3.52|0.1|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.|
1660224|NCT01556165|3053863|Superiority or Other||Mean Difference (Final Values)|-0.67|Standard Error of the Mean|0.52||0.1963|2-Sided|95.0|-1.7|0.35|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.|
1660225|NCT01556165|3053864|Superiority or Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.21||0.0032|2-Sided|95.0|-1.03|-0.21|||ANCOVA|The same ANCOVA methodology as for the primary endpoint was used.||LOCF (last observation carried forward) was used.|
1660226|NCT01556165|3053865|Superiority or Other||Mean Difference (Final Values)|-3.0|Standard Error of the Mean|1.32||0.0254|2-Sided|75.0|-4.53|-1.47||No adjustments for multiple comparisons were made.|ANCOVA|||This study was designed to show a trend, that is, to show a clinical difference in the primary efficacy analysis, at a two-sided significance level of 0.25. Assuming a difference between rasagiline and placebo of a 3-point change in the UPDRS total score and a standard deviation on the change from baseline of 7 points, a sample size of 60 patients per treatment group gave an 88% probability of showing a trend. LOCF (last observation carried forward) was used.|
1660227|NCT01555983|3053871|Superiority or Other||Cochran-Armitage trend tes|0.0001|||<|0.05|2-Sided||||||Mixed Models Analysis|||The number needed to treat (NNT) to achieve 30% pain reduction during the 8-hour period was 4 (95% CI: 2.1-25.3) for the lower dose vs. placebo, and 3 (95% CI: 1.6-4.2) for the higher dose versus placebo.|
1660228|NCT01555463|3053913|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|F-test for treatment effect of the ANCOVA model with treatment group and study center as the factors and baseline lesion count as the covariate.|||
1660229|NCT01555463|3053914|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel|center-adjusted|||
1660230|NCT01555164|3053917|Superiority or Other||difference in least squares mean (LSM)|-0.11||||0.306|2-Sided|95.0|-0.31|0.1||P-value from a mixed-effect model including terms for baseline HbA1c value, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.4% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.|
1660231|NCT01555125|3053961|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1660232|NCT01555125|3053961|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1660233|NCT01555125|3053962|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1660234|NCT01555125|3053962|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1660235|NCT01554904|3053979|Superiority or Other||Mean Difference (Final Values)|-0.85|Standard Error of the Mean|0.66||0.22|2-Sided|95.0|-2.28|0.584||paired t test|t-test, 2 sided|||Participants completing 6 weeks of training and the second sleep study. The null hypothesis was that the AHI would not be different after 6 weeks of training compared to baseline.|
1660236|NCT01554904|3053980|Superiority or Other||Mean Difference (Final Values)|162.24|Standard Error of the Mean|62.4||0.02|2-Sided|95.0|27.32|297.16|||paired t test|||The null hypothesis is that the snore index would not be different after 6 weeks of treatment compared to baseline. The comparison group is the subjects completing the 6 weeks of training and the second sleep study.|
1660237|NCT01554527|3053990|Superiority|||||||0.25|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)|
1660238|NCT01554527|3053991|Superiority|||||||0.5|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)|
1660239|NCT01554527|3053992|Superiority|||||||0.93|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)|
1660240|NCT01554527|3053993|Superiority|||||||0.34|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)|
1660241|NCT01554527|3053994|Superiority|||||||0.07|||||||t-test, 2 sided|||Intent to treat for controls vs. treatment (adherent/non-adherent)|
1660242|NCT01554488|3054003|Other||Mean Difference (Net)|-1.03|||||2-Sided|95.0|-5.03|2.92||||||All of the comparisons were based on mixed effects linear regression models with visit and group*visit as fixed effects and subject as a random effect. Confidence intervals for the treatment difference (group*visit interaction) were constructed using the Wald method.|
1660243|NCT01554241|3054004|Superiority or Other||||||<|0.0003|||||||ANOVA|Bonferroni/Dunn adjustment|||
1660244|NCT01554241|3054004|Superiority or Other||||||<|0.0001|||||||ANOVA|Bonferroni/Dunn adjustment|||
1660245|NCT01554241|3054004|Superiority or Other||||||<|0.02|||||||ANOVA|Bonferroni/Dunn adjustment|||
1660246|NCT01554241|3054004|Superiority or Other||||||<|0.0001|||||||ANOVA|Bonferroni/Dunn adjustment|||
1660247|NCT01554241|3054004|Superiority or Other||||||<|0.002|||||||ANOVA|Bonferroni/Dunn adjustment|||
1660248|NCT01554241|3054004|Superiority or Other||||||=|0|||||||ANOVA|Bonferroni/Dunn adjustment|||
1660249|NCT01554241|3054004|Superiority or Other||||||<|0.0001||||||analyses were corrected for multiple comparisons (Bonferroni)|ANOVA||||
1660250|NCT01554241|3054005|Superiority or Other||||||<|0.0001|||||||ANOVA|Bonferroni/Dunn adjustment|||
1660251|NCT01554241|3054005|Superiority or Other||||||<|0.0001|||||||ANOVA|Bonferroni/Dunn adjustment|||
1660252|NCT01554241|3054005|Superiority or Other||||||<|0.006|||||||ANOVA|Bonferroni/Dunn adjustment|||
1660253|NCT01554241|3054005|Superiority or Other||||||<|0.0001|||||||ANOVA|Bonferroni/Dunn adjustment|||
1660256|NCT01554241|3054005|Superiority or Other||||||<|0.0001|||||||ANOVA|Results presented were Bonferonni-corrected for a mid-point safety analysis||Comparisons of concentrations in D3 dosing groups at study end were made by ANOVA. Adherence of 80% was pre-specified for inclusion in analyses. .|
1660257|NCT01554176|3054008|Superiority or Other||Difference in percentage incidence|0.0|||||2-Sided|95.0|-7.0|7.0||||||Estimated parameter is between-group difference in percentage of participants discontinued from study drug due to an AE = percentage (filorexant 10 mg) - percentage (placebo).|
1660258|NCT01554176|3054009|Superiority or Other||Difference in percentage incidence|15.6|||||2-Sided|95.0|-0.9|31.4||||||Estimated parameter is between-group difference in percentage of participants with an AE = percentage (filorexant 10 mg) - percentage (placebo) for participants with one or more AE.|
1660259|NCT01554176|3054010|Superiority or Other||Estimated Odds Ratio|2.5||||0.0965|2-Sided|95.0|0.8|7.3||Generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction.|Generalized Linear Mixed Effects Model|||Pairwise Comparison: Filorexant 10 mg vs. Placebo|
1660260|NCT01554176|3054011|Superiority or Other||Difference in least squares means|-0.3||||0.701|2-Sided|95.0|-1.9|1.3||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items [HAM-D17] ≤20, >20) and insomnia severity index (ISI ≤14, >14).|cLDA|||Pairwise Comparison: Filorexant 10 mg vs. Placebo|
1660261|NCT01554176|3054012|Superiority or Other||Difference in least squares means|-0.3||||0.82|2-Sided|95.0|-3.2|2.5||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items [HAM-D17] ≤20, >20) and insomnia severity index (ISI ≤14, >14).|cLDA|||Pairwise Comparison: Filorexant 10 mg vs. Placebo|
1660262|NCT01554176|3054013|Superiority or Other||Difference in least squares means|-0.7||||0.679|2-Sided|95.0|-3.8|2.5||cLDA model included terms for treatment, time, the interaction of time by treatment, severity of disease (Hamilton Depression Rating Scale, 17-items [HAM-D17] ≤20, >20) and insomnia severity index (ISI ≤14, >14).|cLDA|||Number of participants included for calculation of mean ± SD baseline and mean ± SD change from baseline MADRS Total Score is 119. Constrained longitudinal data analysis (cLDA) model uses efficacy Full Analysis Set (FAS) population (number of participants: filorexant 10 mg - 64, placebo - 64; total number of participants in cLDA analysis - 128).|
1660263|NCT01554163|3054014|Superiority or Other||Difference in LS Mean Change|-0.1||||0.314|2-Sided|95.0|-0.3|0.1|||ANCOVA||||
1660264|NCT01554163|3054015|Superiority or Other||Difference in LS Mean Change|-0.86||||0.679|2-Sided|95.0|-4.96|3.24|||ANCOVA||||
1660265|NCT01554163|3054016|Superiority or Other||Difference in LS Mean Change|-0.09||||0.294|2-Sided|95.0|-0.25|0.08|||ANCOVA||||
1660266|NCT01554163|3054017|Superiority or Other||Difference in LS Mean Change|-0.08||||0.369|2-Sided|95.0|-0.26|0.1|||ANCOVA||||
1660267|NCT01554163|3054018|Non-Inferiority or Equivalence|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.|Difference in LS Mean Change|-1.09||||0.624|2-Sided|95.0|-5.48|3.3|||ANCOVA||||
1660268|NCT01554163|3054019|Non-Inferiority or Equivalence|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in LS means (etoricoxib minus celecoxib) is no greater than 10 mm.|Difference in LS Mean Change|-1.32||||0.464|2-Sided|95.0|-4.88|2.23|||ANCOVA||||
1660269|NCT01554163|3054020|Non-Inferiority or Equivalence|Etoricoxib 30 mg will be considered non-inferior to celecoxib 200 mg if the upper bound of the two-sided 95% confidence interval of the betweentreatment difference in LS mean time-weighted average change from baseline over 12 weeks in WOMAC Pain Subscale (VAS) is no greater than 10 mm (non-inferiority margin).|Difference in LS Mean Change|-1.63||||0.39|2-Sided|95.0|-5.37|2.1|||ANCOVA||||
1660270|NCT01553747|3054056|Superiority||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.|
1660271|NCT01553747|3054056|Superiority||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.|
1660272|NCT01553747|3054057|Superiority||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.|
1660273|NCT01553747|3054057|Superiority||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.|
1660274|NCT01553591|3054073|Superiority||||||<|0.001||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.|
1660275|NCT01553591|3054073|Superiority||||||<|0.112||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.|
1660276|NCT01553591|3054074|Superiority|||||||0.004||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.|
1660277|NCT01553591|3054074|Superiority|||||||0.014||||||Significance level of 0.025|Chi-square test statistic|||The family-wise error rate was controlled by Bonferroni adjustment for each active dose versus placebo.|
1660278|NCT01553188|3054129|Superiority|||||||0.26|||||||Log rank two-tailed p-value||||
1660279|NCT01553188|3054131|Superiority|||||||0.44|||||||Log rank two-tailed p-value||||
1660280|NCT01553084|3054137|Superiority||Mean Difference (Final Values)|-0.00612|Standard Error of the Mean|0.00625||0.3282|2-Sided||||||t-test, 2 sided|df=710|||
1660281|NCT01553084|3054138|Superiority||Odds Ratio (OR)|0.8||||0.19|2-Sided|95.0|0.6|1.1|||Regression, Logistic||||
1660282|NCT01553084|3054138|Superiority||Odds Ratio (OR)|1.5||||0.03|2-Sided|95.0|1.1|2.2|||Regression, Logistic||||
1660283|NCT01553084|3054139|Superiority||Hazard Ratio (HR)|0.943||||0.5503|2-Sided|95.0|0.779|1.142|||Regression, Cox||||
1660284|NCT01553084|3054139|Superiority||Hazard Ratio (HR)|0.915||||0.3613|2-Sided|95.0|0.756|1.107|||Regression, Cox||||
1660285|NCT01553084|3054140|Superiority||Odds Ratio (OR)|0.9||||0.1947|2-Sided|95.0|0.6|1.2|||Regression, Logistic|||Varenicline will be compared statististically versus Nicotine patch only (the reference or control group).|
1660286|NCT01553084|3054140|Superiority||Odds Ratio (OR)|1.2||||0.3623|2-Sided|95.0|0.8|1.7|||Regression, Logistic|||Combination NRT will be compared statististically versus Nicotine patch only (the reference or control group).|
1660287|NCT01553058|3054141|Other|Difference of differences||||||0.628|||||||Regression, Linear||||
1660288|NCT01553058|3054141|Other|Difference of differences||||||0.006|||||||Regression, Linear||||
1660289|NCT01553058|3054142|Other|Difference of differences||||||0.019|||||||Regression, Linear||||
1660290|NCT01553058|3054142|Other|Difference of differences||||||0.007|||||||Regression, Linear||||
1660291|NCT01553058|3054143|Other|Difference of differences||||||0.065|||||||Regression, Linear||||
1660292|NCT01553058|3054143|Other|Difference of Differences|||||<|0.001|||||||Regression, Linear||||
1660293|NCT01553058|3054144|Other|Difference of differences||||||0.009|||||||Regression, Linear||||
1660294|NCT01553058|3054144|Other|Difference of differences||||||0.002|||||||Regression, Linear||||
1660295|NCT01553058|3054145|Other|Difference of differences||||||0.695|||||||Regression, Linear||||
1660296|NCT01553058|3054145|Other|Difference of differences||||||0.504|||||||Regression, Linear||||
1660297|NCT01553058|3054146|Other|Difference of differences||||||0.655|||||||Regression, Linear||||
1660298|NCT01553058|3054146|Other|Difference of differences||||||0.672|||||||Regression, Linear||||
1660299|NCT01553058|3054147|Other|Difference of differences||||||0.679|||||||Regression, Linear||||
1660300|NCT01553058|3054147|Other|Difference of differences||||||0.934|||||||Regression, Linear||||
1660301|NCT01553058|3054148|Other|Difference of differences||||||0.03|||||||Regression, Linear||||
1660302|NCT01553058|3054148|Other|Difference of differences||||||0.089|||||||Regression, Linear||||
1660303|NCT01553058|3054149|Other|Difference of differences||||||0.467|||||||Regression, Linear||||
1660304|NCT01553058|3054149|Other|Difference of Differences||||||0.897|||||||Regression, Linear||||
1660305|NCT01553058|3054150|Other|Difference of Differences||||||0.496|||||||Regression, Linear||||
1660306|NCT01553058|3054150|Other|Difference of Differences||||||0.357|||||||Regression, Linear||||
1660307|NCT01553058|3054157|Other|Difference of Differences||||||0.28|||||||Regression, Linear||||
1660308|NCT01553058|3054157|Other|Difference of differences||||||0.386|||||||Regression, Linear||||
1660309|NCT01553058|3054158|Other|Difference of differences||||||0.647|||||||Regression, Linear||||
1660310|NCT01553058|3054158|Other|Difference of Differences||||||0.795|||||||Regression, Linear||||
1660311|NCT01552954|3054159|Superiority or Other|||||||0.585||||||for dBP changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided||||
1660312|NCT01552954|3054159|Superiority or Other||||||>|0.05||||||for sBP changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided||||
1660313|NCT01552954|3054160|Superiority or Other|||||||0.001||||||for changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided||||
1660314|NCT01552954|3054161|Superiority or Other|||||||0.187||||||for hemoglobin changes from week 0 at week 16 (week 0 - week 16)|t-test, 2 sided||||
1660315|NCT01552954|3054162|Superiority or Other|||||||0.001||||||for 24-hour urine albumin excretion between 8 weeks and 16 weeks in intensive education group|Mixed Models Analysis||||
1660316|NCT01552954|3054162|Superiority or Other|||||||0.99||||||for 24-hour urine albumin excretion between 8 weeks and 16 weeks|Mixed Models Analysis||||
1660317|NCT01552954|3054162|Superiority or Other|||||||0.006||||||for albuminuria changes from week 8 at week 16 (week 8 - week 16)|t-test, 2 sided|||Differences with two-tailed P<0.05 were considered statistically significant.|
1660318|NCT01552928|3054163|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660319|NCT01552928|3054163|Superiority or Other||||||<|0.274|||||||ANCOVA||||
1660320|NCT01552928|3054163|Superiority or Other||||||<|0.439|||||||ANCOVA||||
1660321|NCT01552928|3054164|Superiority or Other|||||||0.156|||||||ANCOVA||||
1660322|NCT01552928|3054164|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660323|NCT01552928|3054164|Superiority or Other||||||<|0.078|||||||ANCOVA||||
1660324|NCT01552928|3054165|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660325|NCT01552928|3054165|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660326|NCT01552928|3054165|Superiority or Other||||||<|0.005|||||||ANCOVA||||
1660327|NCT01552928|3054166|Superiority or Other|||||||0.004|||||||ANCOVA||||
1660328|NCT01552928|3054166|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660329|NCT01552928|3054166|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660330|NCT01552928|3054167|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660331|NCT01552928|3054167|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660332|NCT01552928|3054167|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660333|NCT01552928|3054172|Superiority or Other|||||||0.043|||||||ANCOVA||||
1660334|NCT01552928|3054172|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660335|NCT01552928|3054172|Superiority or Other||||||<|0.003|||||||ANCOVA||||
1660336|NCT01552928|3054173|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660337|NCT01552928|3054173|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660338|NCT01552928|3054173|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660339|NCT01552928|3054174|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660340|NCT01552928|3054174|Superiority or Other||||||<|0.044|||||||ANCOVA||||
1660341|NCT01552928|3054174|Superiority or Other||||||<|0.012|||||||ANCOVA||||
1660342|NCT01552928|3054175|Superiority or Other|||||||0.001|||||||ANCOVA||||
1660343|NCT01552928|3054175|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660344|NCT01552928|3054175|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660345|NCT01552928|3054176|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1660351|NCT01552915|3054181|Superiority or Other||Difference in LS Mean|-10.1|Standard Error of the Mean|1.43|<|0.0001|2-Sided|95.0|-13.0|-7.3|||mixed effects model for repeated measure||||
1660352|NCT01552915|3054181|Superiority or Other||Difference in LS Mean|-12.2|Standard Error of the Mean|1.45|<|0.0001|2-Sided|95.0|-15.1|-9.4|||mixed effects model for repeated measure||||
1660353|NCT01552915|3054181|Superiority or Other||Difference in LS Mean|-2.1|Standard Error of the Mean|1.15|<|0.0717|2-Sided|95.0|-4.3|0.2|||mixed effects model for repeated measure||||
1660354|NCT01552902|3054186|Superiority or Other||Difference in LSM|-5.1|||<|0.0001|2-Sided|95.0|-7.6|-2.6|||Mixed Models Analysis|||The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that includes treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.|
1660355|NCT01552902|3054186|Superiority or Other||Difference in LSM|-8.5|||<|0.0001|2-Sided|95.0|-11.0|-6.0|||Mixed Models Analysis|||The LSM, the difference in LSM and its 95% CI, and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on REML method of estimation and utilized an unstructured covariance.|
1660356|NCT01552902|3054186|Superiority or Other||Difference in LSM|-3.4|||=|0|2-Sided|95.0|-5.4|-1.3|||Mixed Models Analysis|||The least squares mean (LSM), the difference in LSM and its 95% confidence interval (CI), and the p-value were from a mixed effects model for repeated measures that included treatment group, visit, interaction of the treatment group with the visit as factors, baseline score as a covariate, and an adjustment for the interaction of the baseline score with the visit. The model was based on Restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance.|
1660357|NCT01552694|3054208|Superiority or Other|||||||0.78||||||A priori threshold for statistical significance was p<0.05. Unadjusted analysis|t-test, 2 sided||||
1660358|NCT01552694|3054209|Superiority or Other|||||||0.24||||||A priori threshold for statistical significance was p<0.05. Unadjusted analysis.|t-test, 2 sided||||
1660359|NCT01552694|3054210|Superiority or Other|||||||0.006||||||A priori threshold for statistical significance was p<0.05. Unadjusted p-value compares the change (week 8 - baseline) for plasma hsCRP between the 2 groups.|t-test, 2 sided||||
1660360|NCT01552681|3054232|Superiority or Other|||||||0.33||||||P-value is testing for treatment effect using an analysis of covariance with adjustments for screening stimulated salivary flow.|ANCOVA|||Missing Week 24 assessments were imputed by carrying forward the last observed post-baseline value.|
1660361|NCT01552369|3054243|Superiority|||||||0.61|||||||Chi-squared||||
1660362|NCT01552369|3054244|Superiority|||||||0.57|||||||Chi-squared||||
1660363|NCT01552369|3054245|Superiority|||||||0.69|||||||Chi-squared||||
1660364|NCT01552369|3054246|Superiority|||||||0.24|||||||Fisher Exact||||
1660365|NCT01552369|3054247|Superiority||Odds Ratio (OR)|2.25||||0.18|2-Sided|95.0|0.66|7.62|||Mantel Haenszel||Odds of fungal disease in prophylaxis group compared to preemptive||
1660366|NCT01552369|3054248|Superiority||Odds Ratio (OR)|1.17||||0.64|2-Sided|95.0|0.61|2.23|||Mantel Haenszel||Odds of bacterial infection in prophylaxis subjects compared to preemptive||
1660367|NCT01552369|3054249|Superiority||Odds Ratio (OR)|3.24||||0.014|2-Sided|95.0|1.21|8.69|||Mantel Haenszel||Odds of late disease in prophylaxis group compared to preemptive||
1660368|NCT01552369|3054250|Superiority||Odds Ratio (OR)|0.95||||0.96|2-Sided|95.0|0.13|6.92|||Mantel Haenszel||The odds of graft loss in prophylaxis group compared to preemptive group||
1660369|NCT01552369|3054251|Superiority||Odds Ratio (OR)|0.85||||0.6|2-Sided|95.0|0.45|1.58|||Mantel Haenszel||The odds of rejection in prophylaxis group compared to preemptive group||
1660370|NCT01552369|3054252|Superiority|log-rank test for equality of survivor functions||||||0.19|||||||Log Rank||||
1660371|NCT01552369|3054253|Superiority||Hazard Ratio (HR)|2.22||||0.048|2-Sided|95.0|1.01|7.3|||Competing risk regression|Death was considered a competing risk.|The risk of CMV disease is 2.2x higher in the prophylaxis group when compared to the preemptive group||
1660372|NCT01552369|3054253|Superiority|||||||0.0396|||||||Mantel Haenszel||||
1660373|NCT01552343|3054256|Superiority||Mean Difference (Final Values)|-0.1||||0.9647|2-Sided|95.0|-6.6|6.3|||ANCOVA|Covariates baseline score, treatment and age stratum (<65, >=65).||Treatment effect. NI total scores are transformed to a 0-100 scale where 0 is good and 100 bad.|
1660374|NCT01552343|3054257|Superiority or Other||Mean Difference (Net)|-17.7||||0.0413|2-Sided|95.0|-34.6|-0.7||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Overall Impact Question (Q12): Baseline|
1660375|NCT01552343|3054257|Superiority or Other||Mean Difference (Net)|-15.8||||0.0463|2-Sided|95.0|-31.2|-0.3||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Overall Impact Question (Q12): Screening|
1660376|NCT01552343|3054257|Superiority or Other||Mean Difference (Net)|-13.6||||0.0318|2-Sided|95.0|-26.0|-1.2||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Nocturia Impact (NI) Total Score: Baseline|
1660377|NCT01552343|3054257|Superiority or Other||Mean Difference (Net)|-8.6||||0.1471|2-Sided|95.0|-20.3|3.1||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Nocturia Impact (NI) Total Score: Screening|
1660378|NCT01552343|3054260|Superiority or Other||Mean Difference (Net)|0.0|||||2-Sided|95.0|-9.6|9.6|||||Non-Responders - Responders|Overall Impact Question (Q12)|
1660379|NCT01552343|3054260|Superiority or Other||Mean Difference (Net)|10.7|||||2-Sided|95.0|2.7|18.8|||||Non-Responders - Responders|Nocturia Impact (NI) Total Score (Q1-Q11)|
1660380|NCT01552343|3054261|Superiority or Other|||||||0.0128|||||||t-test, 2 sided|The a priori threshold for statistical significance was 0.05.||Partial correlation - gender|
1660381|NCT01552343|3054261|Superiority or Other|||||||0.0133||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - age category|
1660382|NCT01552343|3054261|Superiority or Other|||||||0.0383||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - baseline NI total score|
1660383|NCT01552343|3054261|Superiority or Other|||||||0.0094||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Partial correlation - baseline # of voids|
1660384|NCT01552343|3054261|Superiority or Other|||||||0.0187||||||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|||Correlation - no adjustments|
1660385|NCT01552213|3054263|Superiority|||||||0.56|||||||Chi-squared||||
1660386|NCT01552213|3054264|Superiority|||||||1|||||||Chi-squared||||
1660387|NCT01552213|3054265|Superiority|||||||0.46|||||||Chi-squared||||
1660388|NCT01552213|3054266|Superiority|||||||0.5|||||||t-test, 2 sided||||
1660389|NCT01552213|3054267|Superiority|||||||0.42|||||||t-test, 2 sided||||
1660390|NCT01552213|3054268|Superiority|||||||0.36|||||||Chi-squared||||
1660391|NCT01552213|3054269|Superiority|||||||0.6|||||||t-test, 2 sided||||
1660392|NCT01552213|3054270|Superiority|||||||0.5|||||||Chi-squared||||
1660393|NCT01552213|3054271|Superiority|||||||0.95|||||||Chi-squared||||
1660394|NCT01552213|3054272|Superiority|||||||0.75|||||||t-test, 2 sided||||
1660395|NCT01552213|3054273|Superiority|||||||0.01|||||||t-test, 2 sided||||
1660396|NCT01552213|3054274|Superiority|||||||0.96|||||||Chi-squared||||
1660397|NCT01552213|3054275|Superiority|||||||0.32|||||||Chi-squared||||
1660398|NCT01552213|3054276|Superiority||Risk Ratio (RR)|0.8||||0.32|2-Sided|95.0|0.53|1.24|||Chi-squared||||
1660399|NCT01552057|3054277|Superiority or Other||Mean Difference (Final Values)|-0.38||||0.0408|2-Sided|95.0|-0.74|-0.02||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA||||
1660400|NCT01552057|3054278|Superiority or Other||Mean Difference (Final Values)|-0.44||||0.0226|2-Sided|95.0|-0.82|-0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM||||
1660401|NCT01552057|3054279|Superiority or Other||Mean Difference (Final Values)|-0.72|||<|0.0001|2-Sided|95.0|-1.07|-0.37||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM||||
1660402|NCT01552057|3054280|Superiority or Other||Mean Difference (Final Values)|-0.61||||0.0005|2-Sided|95.0|-0.94|-0.27||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM||||
1660403|NCT01552057|3054281|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.0113|2-Sided|95.0|-0.71|-0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM||||
1660404|NCT01552057|3054282|Superiority or Other||Mean Difference (Final Values)|-0.52||||0.0222|2-Sided|95.0|-0.96|-0.07||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Average Interference|
1660405|NCT01552057|3054282|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.0119|2-Sided|95.0|-1.18|-0.15||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Enjoyment of Life|
1660406|NCT01552057|3054282|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.3959|2-Sided|95.0|-0.81|0.32||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Sleep|
1660407|NCT01552057|3054282|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.0264|2-Sided|95.0|-1.04|-0.07||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Relationships With Other People|
1660408|NCT01552057|3054282|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.1081|2-Sided|95.0|-0.94|0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Normal Work|
1660409|NCT01552057|3054282|Superiority or Other||Mean Difference (Final Values)|-0.38||||0.1114|2-Sided|95.0|-0.84|0.09||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Walking Ability|
1660410|NCT01552057|3054282|Superiority or Other||Mean Difference (Final Values)|-0.75||||0.0057|2-Sided|95.0|-1.29|-0.22||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With Mood|
1660411|NCT01552057|3054282|Superiority or Other||Mean Difference (Final Values)|-0.46||||0.0807|2-Sided|95.0|-0.98|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Interference With General Activity|
1660412|NCT01552057|3054282|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.0083|2-Sided|95.0|-1.0|-0.15||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Pain Right Now|
1660413|NCT01552057|3054282|Superiority or Other||Mean Difference (Final Values)|-0.49||||0.0092|2-Sided|95.0|-0.87|-0.12||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Least Pain|
1660414|NCT01552057|3054282|Superiority or Other||Mean Difference (Final Values)|-0.56||||0.0126|2-Sided|95.0|-0.99|-0.12||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Worst Pain|
1660415|NCT01552057|3054283|Superiority or Other||Mean Difference (Final Values)|-0.47||||0.0232|2-Sided|95.0|-0.88|-0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Worst Pain|
1660416|NCT01552057|3054283|Superiority or Other||Mean Difference (Final Values)|-0.33||||0.0755|2-Sided|95.0|-0.7|0.03||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Average Pain|
1660417|NCT01552057|3054284|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.0906|2-Sided|95.0|-0.79|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||Symptom Severity|
1660418|NCT01552057|3054284|Superiority or Other||Mean Difference (Final Values)|-1.28||||0.0029|2-Sided|95.0|-2.12|-0.44||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM|||WPI|
1660419|NCT01552057|3054285|Superiority or Other||Mean Difference (Final Values)|-2.85||||0.0002|2-Sided|95.0|-4.32|-1.38||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM||||
1660420|NCT01552057|3054286|Superiority or Other||Mean Difference (Final Values)|7.91|||<|0.0001|2-Sided|95.0|4.39|11.43||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Mental Health|
1660421|NCT01552057|3054286|Superiority or Other||Mean Difference (Final Values)|9.12|||<|0.0002|2-Sided|95.0|4.41|13.83||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Role-Emotional|
1660422|NCT01552057|3054286|Superiority or Other||Mean Difference (Final Values)|7.04|||<|0.0014|2-Sided|95.0|2.74|11.34||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Social Functioning|
1660423|NCT01552057|3054286|Superiority or Other||Mean Difference (Final Values)|6.7|||<|0.0002|2-Sided|95.0|3.15|10.25||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Vitality|
1660424|NCT01552057|3054286|Superiority or Other||Mean Difference (Final Values)|3.25|||<|0.0192|2-Sided|95.0|0.53|5.96||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||General Health|
1660425|NCT01552057|3054286|Superiority or Other||Mean Difference (Final Values)|5.67|||<|0.0002|2-Sided|95.0|2.76|8.59||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Bodily Pain|
1660426|NCT01552057|3054286|Superiority or Other||Mean Difference (Final Values)|7.76|||<|0.0003|2-Sided|95.0|3.57|11.94||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Role-Physical|
1660427|NCT01552057|3054286|Superiority or Other||Mean Difference (Final Values)|4.34|||<|0.0049|2-Sided|95.0|1.32|7.35||Statistical tests were conducted at a 2-sided alpha level of 0.05.|ANCOVA|||Physical Functioning|
1660428|NCT01552057|3054287|Superiority or Other||Mean Difference (Final Values)|-5.35||||0.0073|2-Sided|95.0|-9.26|-1.45||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM||||
1660429|NCT01552057|3054288|Superiority or Other||Mean Difference (Final Values)|-0.44||||0.0012|2-Sided|95.0|-0.71|-0.18||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM||||
1660430|NCT01552057|3054289|Superiority or Other||Mean Difference (Final Values)|-0.49||||0.0003|2-Sided|95.0|-0.76|-0.22||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM||||
1660431|NCT01552057|3054290|Superiority or Other||Mean Difference (Final Values)|-0.32||||0.0988|2-Sided|95.0|-0.7|0.06||Statistical tests were conducted at a 2-sided alpha level of 0.05.|MMRM||||
1660432|NCT01551758|3054305|Superiority or Other||Hazard Ratio (HR)|1.27||||0.075|2-Sided|95.0|0.98|1.66|||Cox proportional hazards model||||
1660433|NCT01551758|3054306|Superiority or Other||Hazard Ratio (HR)|0.92||||0.081|2-Sided|95.0|0.84|1.01|||Cox porportional hazards model||||
1660434|NCT01551758|3054307|Superiority or Other||Hazard Ratio (HR)|0.93||||0.111|2-Sided|95.0|0.85|1.02|||Cox porportional hazards model||A hazard ratio <1 indicates a lower risk with FF/VI compared with Usual Care||
1660435|NCT01551758|3054308|Superiority or Other||Hazard Ratio (HR)|0.49|||<|0.001|2-Sided|95.0|0.37|0.66|||Cox proprotional hazards model||A hazard ratio <1 indicates a lower risk with FF/VI compared with Usual Care||
1660436|NCT01551758|3054309|Superiority or Other||Hazard Ratio (HR)|1.89|||<|0.001|2-Sided|95.0|1.6|2.23|||Cox proportional hazards model||A hazard ratio <1 indicates a lower risk with FF/VI compared with Usual Care.||
1660437|NCT01551758|3054310|Superiority or Other||Adjusted treatment ratio|1.12|||<|0.001|2-Sided|95.0|1.05|1.2|||Generalized Linear Model||||
1660438|NCT01551758|3054311|Superiority or Other||Adjusted treatment ratio|1.05||||0.336|2-Sided|95.0|0.95|1.15|||Generalized Linear Model||||
1660439|NCT01551758|3054312|Superiority or Other||Adjusted treatment ratio|0.98||||0.622|2-Sided|95.0|0.92|1.05|||Generalized linear model||||
1660440|NCT01551758|3054313|Superiority or Other||Adjusted treatment ratio|1.06||||0.488|2-Sided|95.0|0.89|1.27|||Generalized linear model||||
1660441|NCT01551758|3054314|Superiority or Other||Hazard Ratio (HR)|1.13|||=|0|2-Sided|95.0|0.83|1.52|||Cox proportional hazards model||||
1660442|NCT01551758|3054315|Superiority or Other||Adjusted treatment ratio|1.08||||0.632|2-Sided|95.0|0.79|1.47|||Generalized linear model||||
1660443|NCT01551758|3054316|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.|Incidence ratio|1.1|||||2-Sided|95.0|0.9|1.5|||||Calculated as % of participants who had at least one SAE of pneumonia in the FF/VI group divided by the % of participants who had at least one SAE of pneumonia in the Usual Care group||
1660444|NCT01551758|3054317|Superiority or Other||Adjusted treatment ratio|0.92|||=|0|2-Sided|95.0|0.85|0.99|||Generalized Linear Model||||
1660445|NCT01551420|3054327|Superiority||Slope|-4.91|Standard Error of the Mean|4.01||0.2346|2-Sided|95.0|-13.3|3.43|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Satisfaction measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660446|NCT01551420|3054327|Superiority||Mean Difference (Final Values)|-10.5|Standard Error of the Mean|6.0||0.0951|2-Sided|95.0|-22.9|1.99|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Perceived Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660447|NCT01551420|3054327|Superiority||Slope|-7.07|Standard Error of the Mean|4.02||0.0932|2-Sided|95.0|-15.43|1.29|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for CRIS-CAT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from CRIS-CAT: Extent of Limitations measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660448|NCT01551420|3054327|Superiority||Mean Difference (Net)|-1.49|Standard Deviation|8.12||0.2361|2-Sided|95.0|-3.99|1.01|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Satisfaction data at both time points).|
1660449|NCT01551420|3054327|Superiority||Mean Difference (Net)|-0.72|Standard Deviation|13.95||0.7363|2-Sided|95.0|-5.01|3.67|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with CRIS: Perceived Limitations data at both time points).|
1660450|NCT01551420|3054327|Superiority||Mean Difference (Net)|0.47|Standard Deviation|7.54||0.6881|2-Sided|95.0|-1.86|2.79|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with CRIS: Extent of Limitations data at both time points).|
1660451|NCT01551420|3054328|Superiority||Slope|-2.39|Standard Error of the Mean|2.46||0.345|2-Sided|95.0|-7.6|2.82|||Regression, Linear|The sample for this analysis was 19participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UEFS measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660452|NCT01551420|3054328|Superiority||Mean Difference (Net)|4.3|Standard Deviation|10.01||0.0465|2-Sided|95.0|0.07|8.53|||t-test, 2 sided|The sample for this paired t-test was 24 participants.|Mean difference is the change in scores from Baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).|
1660453|NCT01551420|3054329|Superiority||Slope|-183.1|Standard Error of the Mean|186.9||0.3397|2-Sided|95.0|-574.3|208.2|||Regression, Linear|The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for T-MAP at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from T-MAP measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660454|NCT01551420|3054329|Superiority||Mean Difference (Net)|253.6|Standard Deviation|325.2|<|0.0001|2-Sided|95.0|146.7|360.5|||t-test, 2 sided|The sample for this paired t-test was 38 participants.||Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with T-MAP data at both time points).|Mean difference is the change in scores from Baseline to End of A.
1660455|NCT01551420|3054330|Superiority||Slope|0.07|Standard Error of the Mean|0.18||0.711|2-Sided|95.0|-0.31|0.44|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Skill at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UNB: Skill measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660456|NCT01551420|3054330|Superiority||Slope|0.13|Standard Error of the Mean|0.17||0.4589|2-Sided|95.0|-0.22|0.48|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UNB: Spontaneity at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UNB: Spontaneity measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660457|NCT01551420|3054330|Superiority||Mean Difference (Net)|-0.02|Standard Deviation|0.64||0.849|2-Sided|95.0|-0.26|0.22|||t-test, 2 sided|The sample for this paired t-test was 30 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Skill data at both time points).|
1660458|NCT01551420|3054330|Superiority||Mean Difference (Net)|-0.04|Standard Deviation|0.52||0.6529|2-Sided|95.0|-0.24|0.15|||t-test, 2 sided|The sample for this paired t-test was 30 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UNB: Spontaneity data at both time points).|
1660459|NCT01551420|3054331|Superiority||Slope|-0.14|Standard Error of the Mean|0.05||0.0073|2-Sided|95.0|-0.24|-0.04|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Heavy Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660460|NCT01551420|3054331|Superiority||Slope|-0.13|Standard Error of the Mean|0.06||0.0319|2-Sided|95.0|-0.25|-0.01|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Light Cans measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660461|NCT01551420|3054331|Superiority|Linear regression of scores from JTHFT: Feeding measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|Slope|-0.06|Standard Error of the Mean|0.03||0.0552|2-Sided|95.0|-0.12|0.0|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)||
1660462|NCT01551420|3054331|Superiority||Slope|0.01|Standard Error of the Mean|0.03||0.6585|2-Sided|95.0|-0.05|0.08|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Checkers measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660463|NCT01551420|3054331|Superiority|Linear regression of scores from JTHFT: Lifting Small Items measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|Slope|-0.03|Standard Error of the Mean|0.03||0.3328|2-Sided|95.0|-0.09|0.03|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)||
1660464|NCT01551420|3054331|Superiority||Slope|-0.04|Standard Error of the Mean|0.03||0.1959|2-Sided|95.0|-0.09|0.02|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Page Turning measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660749|NCT01543685|3055173|Superiority or Other|||||||0.071|||||||t-test, 2 sided||||
1660465|NCT01551420|3054331|Superiority||Slope|-0.06|Standard Error of the Mean|0.07||0.4208|2-Sided|95.0|-0.12|0.09|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for JTHFT at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from JTHFT: Writing measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660466|NCT01551420|3054331|Superiority||Mean Difference (Net)|-0.04|Standard Deviation|0.14||0.1604|2-Sided|95.0|-0.09|0.02|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Heavy Cans data at both time points).|
1660467|NCT01551420|3054331|Superiority||Mean Difference (Net)|-0.03|Standard Deviation|0.12||0.2474|2-Sided|95.0|-0.06|0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Light Cans data at both time points).|
1660468|NCT01551420|3054331|Superiority||Mean Difference (Net)|-0.03|Standard Deviation|0.09||0.1063|2-Sided|95.0|-0.06|0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Feeding data at both time points).|
1660469|NCT01551420|3054331|Superiority||Mean Difference (Net)|-0.05|Standard Deviation|0.08||0.0101|2-Sided|95.0|-0.07|-0.01|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Checkers data at both time points).|
1660470|NCT01551420|3054331|Superiority||Mean Difference (Net)|0.01|Standard Deviation|0.09||0.5942|2-Sided|95.0|-0.02|0.04|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Lifting Small Items data at both time points).|
1660471|NCT01551420|3054331|Superiority||Mean Difference (Net)|-0.02|Standard Deviation|0.06||0.0511|2-Sided|95.0|-0.05|0.0|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Page turning data at both time points).|
1660472|NCT01551420|3054331|Superiority||Mean Difference (Net)|0.01|Standard Deviation|0.17||0.6691|2-Sided|95.0|-0.05|0.07|||t-test, 2 sided|The sample for this paired t-test was 31 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with JTHFT: Writing data at both time points).|
1660473|NCT01551420|3054332|Superiority||Slope|-30.23|Standard Error of the Mean|6.25|<|0.0001|2-Sided|95.0|-43.23|-17.23|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V: Physical Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660474|NCT01551420|3054332|Superiority||Slope|-8.24|Standard Error of the Mean|7.1|<|0.2592|2-Sided|95.0|-23.01|6.54|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V: Social Functioning measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660475|NCT01551420|3054332|Superiority||Slope|-13.35|Standard Error of the Mean|6.91|<|0.0669|2-Sided|95.0|-27.72|1.02|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for SF-36 at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of SF-36V; Role Physical measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660476|NCT01551420|3054332|Superiority||Mean Difference (Net)|-0.61|Standard Deviation|13.9|<|0.7765|2-Sided|95.0|-4.9|3.68|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline to End of A (with SF-36V Physical Functioning data at both time points).|
1660477|NCT01551420|3054332|Superiority||Mean Difference (Net)|-3.78|Standard Deviation|17.37|<|0.161|2-Sided|95.0|-9.12|1.57|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline to End of A (with SF-36V Social Functioning data at both time points).|
1660478|NCT01551420|3054332|Superiority||Mean Difference (Net)|-1.74|Standard Deviation|18.8|<|0.5465|2-Sided|95.0|-7.53|4.05|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data for participants at baseline and completers at End of A (i.e participants with SF-36V Role Physical data at both time points).|
1660479|NCT01551420|3054333|Superiority||Slope|-0.72|Standard Error of the Mean|1.49||0.6339|2-Sided|95.0|-3.84|2.39|||Regression, Linear|The sample for this analysis was 22 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from AM-ULA measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660480|NCT01551420|3054333|Superiority||Mean Difference (Net)|-0.97|Standard Deviation|5.61||0.3367|2-Sided|95.0|-2.99|1.05|||t-test, 2 sided|The sample for this paired t-test was 43 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e. participants with UEFS data at both time points).|
1660750|NCT01543685|3055173|Superiority or Other|||||||0.146|||||||t-test, 2 sided||||
1660481|NCT01551420|3054334|Superiority||Slope|-1.15|Standard Error of the Mean|0.44||0.0168|2-Sided|95.0|-2.06|-0.23|||Regression, Linear|The sample for this analysis was 24 participants with TR or TH amputation level who completed data collection for TAPES at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from TAPES measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660482|NCT01551420|3054334|Superiority||Mean Difference (Net)|-0.22|Standard Deviation|0.94||0.186|2-Sided|95.0|-0.55|0.11|||t-test, 2 sided|The sample for this analysis was 34 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with TAPES data at both time points).|
1660483|NCT01551420|3054335|Superiority||Slope|-0.56|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.73|-0.4|||Regression, Linear|The sample for this analysis was 23 participants with TR or TH amputation level who completed data collection for UEFS at End of Part B.|Effect of EMG-PR (compared to IMU group)|Linear regression of scores from UEFS use measure at 9-12 weeks (End of B), comparing groups by control type, and controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660484|NCT01551420|3054335|Superiority||Mean Difference (Net)|0.3|Standard Deviation|0.42|<|0.0001|2-Sided|95.0|0.17|0.43|||t-test, 2 sided|The sample for this analyses was 44 participants.|Mean difference is the change in scores from baseline to End of A.|Pairwise t-test for data from prosthesis users at baseline and completers at End of A (i.e participants with UEFS data at both time points).|
1660485|NCT01551420|3054336|Superiority||Slope|-0.69||||0.08|2-Sided|95.0|-1.47|0.09|||Regression, Linear|||Linear regression of QOL measure at 9-12 weeks, comparing groups by control type, controlling for amputation level (transhumeral or transradial). Persons with shoulder level devices are excluded from this analysis.|
1660486|NCT01551420|3054336|Superiority|Null hypothesis of no change after home use|Mean Difference (Net)|0.002|Standard Deviation|0.68||0.9358|2-Sided|95.0|-0.27|0.28||Two way comparison between scores at baseline and after 9-12 weeks of Prosthetic use. Alpha=0.05|t-test, 2 sided|paired t-tests|||
1660487|NCT01551355|3054338|Superiority or Other||Mean Difference (Final Values)|5.36|||=|0|2-Sided|95.0|-0.29|11.01|||t-test, 2 sided||||
1660488|NCT01551355|3054339|Superiority or Other||Mean Difference (Final Values)|4.08|||<|0.001|2-Sided|95.0|2.03|6.12|||t-test, 2 sided||||
1660489|NCT01551355|3054340|Superiority or Other||Mean Difference (Final Values)|3.9|||<|0.001|2-Sided|95.0|1.64|6.16|||t-test, 2 sided|The intervention was evaluated using generalized estimating equation models, controlling for cluster effect, sex, age, weight, and education level.|||
1660490|NCT01551212|3054346|Superiority|||||||0.699|||||||Fisher Exact||||
1660491|NCT01551212|3054347|Superiority||Mean Difference (Final Values)|7.99||||0.0085|2-Sided|95.0|2.06|13.92|||ANCOVA|factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs > 30) covariate: baseline value|||
1660492|NCT01551212|3054348|Superiority||Mean Difference (Final Values)|4.09||||0.097|2-Sided|95.0|-0.74|8.91|||ANCOVA|factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs > 30) covariate: baseline value|||
1660493|NCT01550965|3054384|Superiority or Other||Mean Difference (Final Values)|-27.22|||<|0.001|2-Sided|95.0|-30.28|-24.16|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 26.|
1660494|NCT01550965|3054384|Superiority or Other||Mean Difference (Final Values)|-24.42|||<|0.001|2-Sided|95.0|-27.33|-21.5|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).|
1660495|NCT01550965|3054384|Superiority or Other||Mean Difference (Final Values)|-25.43|||<|0.001|2-Sided|95.0|-28.3|-22.56|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 8.|
1660496|NCT01550965|3054384|Superiority or Other||Mean Difference (Final Values)|-18.16|||<|0.001|2-Sided|95.0|-20.47|-15.85|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of activity impairment from week 0 to week 2.|
1660497|NCT01550965|3054385|Superiority or Other||Mean Difference (Final Values)|-29.22|||<|0.001|2-Sided|95.0|-33.5|-24.93|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 26.|
1660498|NCT01550965|3054385|Superiority or Other||Mean Difference (Final Values)|-25.33|||<|0.001|2-Sided|95.0|-29.97|-20.7|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.|
1660499|NCT01550965|3054385|Superiority or Other||Mean Difference (Final Values)|-26.54|||<|0.001|2-Sided|95.0|-31.08|-22.0|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 8.|
1660500|NCT01550965|3054385|Superiority or Other||Mean Difference (Final Values)|-18.34|||<|0.001|2-Sided|95.0|-22.1|-14.57|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: overall work impairment percentage from week 0 to week 2.|
1660501|NCT01550965|3054386|Superiority or Other||Mean Difference (Final Values)|-24.45|||<|0.001|2-Sided|95.0|-28.33|-20.58|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 26.|
1660502|NCT01550965|3054386|Superiority or Other||Mean Difference (Final Values)|-21.68|||<|0.001|2-Sided|95.0|-25.69|-17.67|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).|
1660503|NCT01550965|3054386|Superiority or Other||Mean Difference (Final Values)|-22.95|||<|0.001|2-Sided|95.0|-26.93|-18.97|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 8.|
1660504|NCT01550965|3054386|Superiority or Other||Mean Difference (Final Values)|-16.56|||<|0.001|2-Sided|95.0|-20.0|-13.12|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of impairment while working from week 0 to week 2.|
1660505|NCT01550965|3054387|Superiority or Other||Mean Difference (Final Values)|-11.43|||<|0.001|2-Sided|95.0|-15.5|-7.35|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 26.|
1660506|NCT01550965|3054387|Superiority or Other||Mean Difference (Final Values)|-11.61|||<|0.001|2-Sided|95.0|-15.82|-7.4|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).|
1660507|NCT01550965|3054387|Superiority or Other||Mean Difference (Final Values)|-12.22|||<|0.001|2-Sided|95.0|-16.27|-8.16|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 8.|
1660508|NCT01550965|3054387|Superiority or Other||Mean Difference (Final Values)|-8.62|||<|0.001|2-Sided|95.0|-12.07|-5.18|||Paired t-test, 2 sided|||Statistical analysis for mean change in WPAI-SHP: percentage of work time missed from week 0 to week 2.|
1660509|NCT01550965|3054388|Superiority or Other||Mean Difference (Final Values)|0.14|||<|0.001|2-Sided|95.0|0.12|0.17|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 26.|
1660510|NCT01550965|3054388|Superiority or Other||Mean Difference (Final Values)|0.12|||<|0.001|2-Sided|95.0|0.1|0.14|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.|
1660511|NCT01550965|3054388|Superiority or Other||Mean Difference (Final Values)|0.13|||<|0.001|2-Sided|95.0|0.11|0.15|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 8.|
1660512|NCT01550965|3054388|Superiority or Other||Mean Difference (Final Values)|0.1|||<|0.001|2-Sided|95.0|0.08|0.11|||Paired t-test, 2 sided|||Statistical analysis for mean change in total EQ-5D-5L total score from week 0 to week 2.|
1660513|NCT01550965|3054389|Superiority or Other||Mean Difference (Final Values)|-4.07|||<|0.001|2-Sided|95.0|-4.43|-3.72|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 26.|
1660514|NCT01550965|3054389|Superiority or Other||Mean Difference (Final Values)|-3.01|||<|0.001|2-Sided|95.0|-3.36|-2.66|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.|
1660515|NCT01550965|3054389|Superiority or Other||Mean Difference (Final Values)|-4.06|||<|0.001|2-Sided|95.0|-4.37|-3.76|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 8.|
1660516|NCT01550965|3054389|Superiority or Other||Mean Difference (Final Values)|-3.22|||<|0.001|2-Sided|95.0|-3.46|-2.99|||Paired t-test, 2 sided|||Statistical analysis for mean change in total SCCAI from week 0 to week 2.|
1660517|NCT01550965|3054390|Superiority or Other||Mean Difference (Final Values)|-1.15|||<|0.001|2-Sided|95.0|-1.23|-1.06|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 26.|
1660518|NCT01550965|3054390|Superiority or Other||Mean Difference (Final Values)|-0.86|||<|0.001|2-Sided|95.0|-0.95|-0.77|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using LOCF.|
1660519|NCT01550965|3054390|Superiority or Other||Mean Difference (Final Values)|-1.08|||<|0.001|2-Sided|95.0|-1.16|-1.0|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 8.|
1660520|NCT01550965|3054390|Superiority or Other||Mean Difference (Final Values)|-0.63|||<|0.001|2-Sided|95.0|-0.69|-0.57|||Paired t-test, 2 sided|||Statistical analysis for mean change in PGA from week 0 to week 2.|
1660521|NCT01550965|3054391|Superiority or Other||Mean Difference (Final Values)|17.4|||<|0.001|2-Sided|95.0|16.08|18.73|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 26.|
1660522|NCT01550965|3054391|Superiority or Other||Mean Difference (Final Values)|14.77|||<|0.001|2-Sided|95.0|13.57|15.96|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 18. Efficacy assessments were not specified at week 18; missing data at week 18 were imputed using last observation carried forward (LOCF).|
1660523|NCT01550965|3054391|Superiority or Other||Mean Difference (Final Values)|15.38|||<|0.001|2-Sided|95.0|14.2|16.56|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 8.|
1660524|NCT01550965|3054391|Superiority or Other||Mean Difference (Final Values)|11.11|||<|0.001|2-Sided|95.0|10.21|12.02|||Paired t-test, 2 sided|||Statistical analysis for mean change in SIBDQ: Total Score from week 0 to week 2.|
1660525|NCT01550965|3054392|Superiority or Other||||||<|0.001|||||||McNemar|||Statistical analysis for percentage of participants with absence of blood in stool from week 0 to week 26.|
1660526|NCT01550965|3054393|Superiority or Other||Mean Difference (Net)|-0.92|||<|0.001|2-Sided|95.0|-1.18|-0.66|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization during primary care doctor visits.|
1660527|NCT01550965|3054393|Superiority or Other||Mean Difference (Net)|-0.01|||<|0.83|2-Sided|95.0|-0.11|0.09|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization during emergency department visits.|
1660528|NCT01550965|3054393|Superiority or Other||Mean Difference (Net)|-4.85|||<|0.001|2-Sided|95.0|-5.42|-4.27|||Paired t-test, 2 sided|||Statistical analysis for overall UC-related outpatient utilization.|
1660529|NCT01550965|3054394|Superiority or Other||Mean Difference (Final Values)|22.6|||<|0.001|2-Sided|95.0|19.55|25.64|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction.|
1660530|NCT01550965|3054394|Superiority or Other||Mean Difference (Final Values)|6.2|||<|0.001|2-Sided|95.0|3.89|8.5|||Paired t-test, 2 sided)|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience.|
1660531|NCT01550965|3054394|Superiority or Other||Mean Difference (Final Values)|18.95|||<|0.001|2-Sided|95.0|15.42|22.48|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects.|
1660751|NCT01543685|3055173|Superiority or Other|||||||0.022|||||||t-test, 2 sided||||
1660532|NCT01550965|3054394|Superiority or Other||Mean Difference (Final Values)|24.37|||<|0.001|2-Sided|95.0|21.5|27.25|||Paired t-test, 2 sided|||Statistical analysis for Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness.|
1660533|NCT01550965|3054395|Superiority or Other||Mean Difference (Net)|-7.3|||<|0.001|2-Sided|95.0|-9.83|-4.78|||Paired t-test, 2 sided||||
1660534|NCT01550965|3054396|Superiority or Other||Mean Difference (Net)|-4308.32|||<|0.001|2-Sided|95.0|-4985.13|-3631.51|||Paired t-test, 2 sided||||
1660535|NCT01550965|3054397|Superiority or Other||Mean Difference (Net)|-1297.77|||<|0.001|2-Sided|95.0|-1562.17|-1033.36|||Paired t-test, 2 sided||||
1660536|NCT01550965|3054398|Superiority or Other||Mean Difference (Net)|-1383.81|||<|0.001|2-Sided|95.0|-1586.36|-1181.26|||Paired t-test, 2 sided|||Hypothesis testing for the second ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.|
1660537|NCT01550965|3054399|Superiority or Other||Mean Difference (Final Values)|17.4|||<|0.001|2-Sided|95.0|16.08|18.73|||paired t-test, 2 sided|||Hypothesis testing for the first ranked primary outcome was performed in a hierarchical order using the two-sided paired t-test for mean change equal to zero.|
1660538|NCT01549964|3054495|Superiority or Other||Least Square Mean difference|-11.2|Standard Error of the Mean|3.53||0.002|2-Sided|95.0|-18.1|-4.2||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements||||
1660539|NCT01549964|3054495|Superiority or Other||LS Mean Difference|-31.3|Standard Error of the Mean|4.4|<|0.001|2-Sided|95.0|-39.9|-22.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements||||
1660540|NCT01549964|3054495|Superiority or Other||LS Mean Difference|-5.1|Standard Error of the Mean|3.49|<|0.142|2-Sided|95.0|-12.0|1.7||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements||||
1660541|NCT01549964|3054495|Superiority or Other||LS Mean Difference|-25.2|Standard Error of the Mean|4.36|<|0.001|2-Sided|95.0|-33.8|-16.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements||||
1660542|NCT01549964|3054496|Superiority or Other||Odds Ratio (OR)|0.84||||0.493|2-Sided|95.0|0.5|1.39||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic||||
1660543|NCT01549964|3054496|Superiority or Other||Odds Ratio (OR)|5.06|||<|0.001|2-Sided|95.0|2.24|11.42||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic||||
1660544|NCT01549964|3054496|Superiority or Other||Odds Ratio (OR)|0.39|||<|0.001|2-Sided|95.0|0.23|0.67||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic||||
1660545|NCT01549964|3054496|Superiority or Other||Odds Ratio (OR)|2.25|||<|0.05|2-Sided|95.0|1.0|5.08||P-Value was obtained from a logistic model with treatment, schedule, baseline HbA1c as explanatory variables.|Regression, Logistic||||
1660546|NCT01549964|3054497|Superiority or Other||LS Mean Difference|0.06|Standard Error of the Mean|0.087||0.524|2-Sided|95.0|-0.12|0.23||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements||||
1660547|NCT01549964|3054497|Superiority or Other||LS Mean Difference|-0.82|Standard Error of the Mean|0.109|<|0.001|2-Sided|95.0|-1.03|-0.6||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements||||
1660548|NCT01549964|3054497|Superiority or Other||LS Mean Difference|0.32|Standard Error of the Mean|0.087|<|0.001|2-Sided|95.0|0.15|0.49||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements||||
1660549|NCT01549964|3054497|Superiority or Other||LS Mean Difference|-0.55|Standard Error of the Mean|0.108|<|0.001|2-Sided|95.0|-0.77|-0.34||MMRM model with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements||||
1660550|NCT01549860|3054515|Superiority or Other||||||<|0.0126||||||The MIST+SOC subjects decreased in their reported mean pain scores and reduced from a median of 3.0 to 0.6 cm after four weeks of study treatment.|ANCOVA||||
1660551|NCT01549860|3054517|Superiority or Other||||||<|0.024|||||||t-test, 2 sided||||
1660552|NCT01549652|3054518|Superiority or Other|||||||0.02|||||||t-test, 2 sided||||
1660553|NCT01549652|3054519|Superiority or Other|||||||0.84|||||||t-test, 2 sided||||
1660554|NCT01549652|3054520|Superiority or Other|||||||0.4|||||||t-test, 2 sided||||
1660555|NCT01549652|3054521|Superiority or Other|||||||0.34|||||||t-test, 2 sided||||
1660556|NCT01549652|3054522|Superiority or Other|||||||0.2|||||||t-test, 2 sided||||
1660557|NCT01549652|3054523|Superiority or Other|||||||0.6||||||Students' t-test for paired samples were used to compare differences between the outcome measures for treatment groups (placebo vs. ondansetron).|t-test, 2 sided|||We aimed for a 20% change in OOWS score to show the treatment effect with a power of 80% and an alpha of 0.05, yielding a target of 23 patients per treatment group.|
1660558|NCT01549652|3054524|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1660559|NCT01549652|3054525|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1660560|NCT01549652|3054526|Superiority or Other|||||||0.91|||||||t-test, 2 sided||||
1660561|NCT01549652|3054527|Superiority or Other|||||||0.47|||||||t-test, 2 sided||||
1660563|NCT01549652|3054529|Superiority or Other|||||||0.87||||||Students’ t-tests for paired samples with Bonferroni correction for multiple comparisons were used to compare differences between the outcome measures for crossover treatment arms (placebo vs. ondansetron).|t-test, 2 sided|||For the purposes of our post-hoc power calculation we considered a 30% treatment effect clinically significant. Based on the mean observed OOWS score during withdrawal during the placebo session and the variance of that mean score and assuming a paired data analysis and an alpha of 0.05, we found that we had 80% power to detect a treatment effect as low as 25% reduction in OOWS.|
1660564|NCT01549405|3054532|Superiority or Other||Mean Difference (Net)|122.1|Standard Deviation|58.0||0|2-Sided|95.0|52.98|132.4|||t-test, 2 sided||||
1660565|NCT01549405|3054533|Superiority or Other|||||||0.002|||||||Mann-Whitney U test||||
1660566|NCT01549314|3054542|Superiority|||||||0.99|||||||t-test, 2 sided|||Change from baseline to 24 months in osteocalcin was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.|
1660567|NCT01549314|3054542|Superiority|||||||0.86|||||||t-test, 2 sided|||Change from baseline to 24 months in osteocalcin was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.|
1660568|NCT01549314|3054543|Superiority|||||||0.78|||||||t-test, 2 sided|||Change from baseline to 24 months in DXA PA spine bone mineral density was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.|
1660569|NCT01549314|3054543|Superiority|||||||0.64|||||||t-test, 2 sided|||Change from baseline to 24 months in DXA PA spine bone mineral density was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.|
1660570|NCT01549314|3054544|Superiority|||||||0.82|||||||t-test, 2 sided|||Change from baseline to 24 months in cortical volumentric bone mineral density was determined and compared between subjects with CF not taking ivacaftor and healthy subjects.|
1660571|NCT01549314|3054544|Superiority|||||||0.77|||||||t-test, 2 sided|||Change from baseline to 24 months in cortical volumentric bone mineral density was determined and compared between subjects with CF taking ivacaftor and subjects with CF not taking ivacaftor.|
1660572|NCT01549275|3054545|Superiority or Other|||||||0.129|||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.|
1660573|NCT01549275|3054545|Superiority or Other|||||||0.021|||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative HCC cultured cells.|
1660574|NCT01549275|3054545|Superiority or Other|||||||0.176|||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.|
1660575|NCT01549275|3054545|Superiority or Other|||||||0.048|||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.|
1660576|NCT01549275|3054545|Superiority or Other|||||||0.032|||||||Fisher Exact|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.|
1660577|NCT01549275|3054545|Superiority or Other|||||||1|||||||Fisher Exact|degrees of freedom = 1||null hypothesis: There is no significant difference in the incidence of change in AJCC TNM stages and survivals 6 months after plating of cells between patients with rapidly and slowly proliferative cultured cells.|
1660578|NCT01549275|3054546|Superiority or Other||||||>|0.1|||||||Chi-squared|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured cancer-associated fibroblasts alone between two groups.|
1660579|NCT01549275|3054546|Superiority or Other||||||<|0.005|||||||Chi-squared|degrees of freedom = 1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured HCC cells with or without concomitant cancer-associated fibroblasts between two groups.|
1660580|NCT01549275|3054546|Superiority or Other||||||<|0.005|||||||Chi-squared|degrees of freedom =1||Null hypothesis: There is no significant difference in the incidence of patients with rapidly proliferative cultured cells between two groups.|
1660581|NCT01548599|3054577|Superiority|||||||0.398|||||||Mixed Models Analysis||||
1660582|NCT01548599|3054578|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1660583|NCT01548599|3054579|Superiority||Odds Ratio (OR)|0.261|Standard Error of the Mean|0.398||0.378|2-Sided|95.0|0.013|5.165|||Mixed Models Analysis||||
1660584|NCT01548599|3054580|Superiority|||||||0.013|||||||Mixed Models Analysis||||
1660585|NCT01548599|3054581|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1660586|NCT01548599|3054582|Superiority||Odds Ratio, log|2.028||||0.002|2-Sided|95.0|0.766|3.289|||Mixed Models Analysis||||
1660587|NCT01548417|3054587|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||Data represent the estimated marginal mean + or - SEM. *P<0.05, mifepristone vs. placebo (linear mixed effects modeling).|
1660588|NCT01548417|3054587|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||Linear Mixed Effect Modeling (MEM) with Restricted Maximum Likelihood estimation was used to measure differences in changes in drinking.|
1660589|NCT01548417|3054588|Superiority or Other|||||||0.003|||||||Mixed Models Analysis|||Linear Mixed Effects Modeling (MEM) with Restricted Maximum Likelihood estimation was used to measure differences in alcohol-cued craving..|
1660590|NCT01546922|3054707|Superiority or Other|||||||0.819||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Social cognition|
1660591|NCT01546922|3054707|Superiority or Other|||||||0.958||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Condition B/A|
1660752|NCT01543685|3055173|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1660592|NCT01546922|3054707|Superiority or Other|||||||0.861||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Time condition B|
1660593|NCT01546922|3054707|Superiority or Other|||||||0.512||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Trail Making Test - Time condition A|
1660594|NCT01546922|3054707|Superiority or Other|||||||0.632||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Digit span backward - Working memory|
1660595|NCT01546922|3054707|Superiority or Other|||||||0.572||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Phonemic fluency|
1660596|NCT01546922|3054707|Superiority or Other|||||||0.536||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Semantic fluency|
1660597|NCT01546922|3054707|Superiority or Other|||||||0.164||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Alertness - Reaction time phasic alertness|
1660598|NCT01546922|3054707|Superiority or Other|||||||0.192||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Alertness - Reaction time tonic alertness|
1660599|NCT01546922|3054707|Superiority or Other|||||||0.329||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Number of commission errors|
1660600|NCT01546922|3054707|Superiority or Other|||||||0.229||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Number of omission errors|
1660601|NCT01546922|3054707|Superiority or Other|||||||0.713||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Visual scanning - Reaction time for target stimuli|
1660602|NCT01546922|3054707|Superiority or Other|||||||0.681||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Number of commission errors|
1660603|NCT01546922|3054707|Superiority or Other|||||||0.531||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Number of omission errors|
1660604|NCT01546922|3054707|Superiority or Other|||||||0.502||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Reaction time visual response|
1660605|NCT01546922|3054707|Superiority or Other|||||||0.905||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Divided attention-Reaction time auditory response|
1660606|NCT01546922|3054707|Superiority or Other|||||||0.451||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rey Complex Figure - Delayed memory|
1660607|NCT01546922|3054707|Superiority or Other|||||||0.111||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rey Complex Figure - Immediate memory|
1660608|NCT01546922|3054707|Superiority or Other|||||||0.614||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Digit Span forward - Short-term memory|
1660609|NCT01546922|3054707|Superiority or Other|||||||0.093||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Recognition|
1660610|NCT01546922|3054707|Superiority or Other|||||||0.35||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Delayed corrected for total memory|
1660611|NCT01546922|3054707|Superiority or Other|||||||0.106||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test- Delayed memory|
1660612|NCT01546922|3054707|Superiority or Other|||||||0.13||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Learning Score|
1660613|NCT01546922|3054707|Superiority or Other|||||||0.227||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Total immediate memory|
1660614|NCT01546922|3054707|Superiority or Other|||||||0.028||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||15 Words Test - Short-term memory|
1660615|NCT01546922|3054707|Superiority or Other|||||||0.713||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||RBMT-Delayed corrected for immediate memory|
1660616|NCT01546922|3054707|Superiority or Other|||||||0.668||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||RBMT - Delayed memory|
1660617|NCT01546922|3054707|Superiority or Other|||||||0.861||||||A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.|Wilcoxon (Mann-Whitney)|||Rivermead Behavioural Memory Test (RBMT) - Immediate memory|
1660618|NCT01546519|3054748|Superiority or Other||Geometric mean ratio|0.86|||||2-Sided|90.0|0.53|1.39||||||AUC0-24hr Severe HI vs. Normal: Based on pooled variance estimates|
1660619|NCT01546519|3054748|Superiority or Other||Geometric mean ratio|1.31|||||2-Sided|90.0|0.91|1.89||||||AUC0-24hr Moderate HI vs. Normal: Based on pooled variance estimates|
1660620|NCT01546519|3054748|Superiority or Other||Geometric mean ratio|1.24|||||2-Sided|90.0|0.89|1.73||||||AUC0-24hr Mild HI vs. Normal: Based on pooled variance estimates|
1660621|NCT01546519|3054749|Superiority or Other||Geometric mean ratio|0.88|||||2-Sided|90.0|0.55|1.41||||||Css Severe HI vs. Normal: Based on pooled variance estimates|
1660622|NCT01546519|3054749|Superiority or Other||Geometric mean ratio|1.27|||||2-Sided|90.0|0.89|1.8||||||Css Moderate HI vs. Normal: Based on pooled variance estimates|
1660623|NCT01546519|3054749|Superiority or Other||Geometric mean ratio|1.24|||||2-Sided|90.0|0.9|1.71||||||Css Mild HI vs. Normal: Based on pooled variance estimates|
1660624|NCT01546519|3054749|Superiority or Other||Geometric mean ratio|0.87|||||2-Sided|90.0|0.55|1.37||||||Cmax Severe HI vs. Normal: Based on pooled variance estimates|
1660625|NCT01546519|3054749|Superiority or Other||Geometric mean ratio|1.3|||||2-Sided|90.0|0.92|1.83||||||Cmax Moderate HI vs. Normal: Based on pooled variance estimates|
1660626|NCT01546519|3054749|Superiority or Other||Geometric mean ratio|1.3|||||2-Sided|90.0|0.95|1.78||||||Cmax Mild HI vs. Normal: Based on pooled variance estimates|
1660627|NCT01546285|3054753|Non-Inferiority or Equivalence|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-3.7|Standard Deviation|4.2|||2-Sided|95.0|-4.73|-2.67||||||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.|
1660628|NCT01546285|3054753|Non-Inferiority or Equivalence|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-3.3|Standard Deviation|2.6|||2-Sided|95.0|-3.95|-2.66||||||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4mmHg and a standard deviation of no more than 5mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is a least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in the systolic, diastolic, and mean BP determinations will be compared. A difference of within 10mmHg is considered equivalent in NIBP.|
1660629|NCT01546285|3054753|Non-Inferiority or Equivalence|This study is to show a mean difference of less than 5mmHg and a standard deviation less than 8mmHg for the difference in systolic, diastolic, and mean BP readings taken by B40 and PRO1000 patient monitors.|Mean Difference (Final Values)|-1.4|Standard Deviation|4.8|||2-Sided|95.0|-2.58|-0.22||||||A total of no less than 65 subjects are needed for this study. Assuming a mean of no more than 4 mmHg and a standard deviation of no more than 5 mmHg for the difference, this sample size ensures that the percent of subjects with equivalent NIBP is at least 80% with 90% confidence. The difference between the B40 and PRO1000 patient monitors in systolic, diastolic, and mean BP determinations will be compared. A difference of within 10 mmHg is considered equivalent in NIBP.|
1660630|NCT01546142|3054764|Superiority or Other||||||<|0.001|||||||ANCOVA|Analysis of covariance (ANCOVA) model included treatment and Baseline PR-SMFIS total scale score.||If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was > 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.|
1660631|NCT01546142|3054765|Superiority or Other||Risk Ratio (RR)|7.838|||<|0.001|2-Sided|95.0|3.299|18.622|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was > 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.|
1660632|NCT01546142|3054766|Superiority or Other||Risk Ratio (RR)|6.271|||<|0.001|2-Sided|95.0|2.908|13.52|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.|
1660633|NCT01546142|3054767|Superiority or Other||Risk Ratio (RR)|2.983|||<|0.001|2-Sided|95.0|2.311|3.849|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (that there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.|
1660634|NCT01546038|3054831|Other||Odds Ratio (OR)|4.2755||||0.0112|2-Sided|80.0|1.3057|13.9994|||Cochran-Mantel-Haenszel||Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.||
1660635|NCT01546038|3054835|Other||Hazard Ratio (HR)|0.569||||0.002|2-Sided|80.0|0.441|0.734||1-sided p-value from the log-rank test stratified by prognosis stratum according to Interactive Voice Response System (IVRS).|Log Rank||Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.||
1660636|NCT01545843|3054845|Superiority or Other|||||||0.202|||||||Mixed Models Analysis||||
1660637|NCT01545388|3054868|Superiority or Other||Difference in least squares mean|2.25|||||2-Sided|95.0|-3.63|8.14|||||||
1660638|NCT01545388|3054868|Superiority or Other||Difference in least squares means|-16.34|||<|0.001|2-Sided|95.0|-23.62|-9.06|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.|||
1660639|NCT01545388|3054868|Superiority or Other||Difference in least squares means|-18.59|||<|0.001|2-Sided|95.0|-25.94|-11.24|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.|||
1660640|NCT01545388|3054869|Non-Inferiority or Equivalence|The non-inferiority margin (Δ) is set as 0.3% to show the non-inferiority of metformin 500 mg q.d. to metformin 250 mg b.i.d.|Difference in least squares means|0.153|||||2-Sided|95.0|0.0|0.306|||||||
1660641|NCT01545388|3054869|Superiority or Other||Difference in least squares means|-0.525|||<|0.001|2-Sided|95.0|-0.713|-0.337|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.|||
1660642|NCT01545388|3054869|Superiority or Other||Difference in least squares means|-0.678|||<|0.001|2-Sided|95.0|-0.868|-0.489|||cLDA|Based on a cLDA model with the terms listed above and a constraint that the mean baseline is the same for all treatment groups.|||
1660643|NCT01545375|3054894|Superiority|The objective was to demonstrate that VE induced by GSK2189242A vaccine (three doses in the first year of life and a booster dose in the second year of life)in preventing clinical AOM diagnosed and verified against AAP criteria was greater than 0%, as compared to the control group. One-sided p-value for the Wald-Test obtained from the general Cox proportional hazard model was calculated.|Vaccine Efficacy|3.81||||0.3016|2-Sided|95.0|-11.35|16.9||The primary objective was met if the one-sided p-value calculated for the null hypothesis H0=[clinical AOM VE ≤ 0%] was lower than defined 1-sided alpha level: (17.8%).|Regression, Cox|||VE-AOM against AAP criteria: Occurrence of AOM during efficacy follow-up period was compared between groups to estimate Vaccine Efficacy (VE) and its 95% confidence interval using the Anderson & Gill model (generalization of Cox proportional hazard model) taking into account for recurrent events [Kelly, 2000]. VE= (1 – hazard ratio) x 100 Censoring occurred at the time of the last scheduled or medically attended visit.|
1660644|NCT01545232|3054899|Superiority or Other|||||||0.1|||||||van Elteren's test for medians||||
1660645|NCT01545232|3054900|Superiority or Other|||||||0.14|||||||van Elteren's test for medians||||
1660646|NCT01545232|3054901|Superiority or Other|||||||0.37|||||||generalized logit model regression||||
1660647|NCT01545232|3054902|Superiority or Other||Risk Difference (RD)|0.3|||||2-Sided|95.0|-0.8|1.7|||||||
1660648|NCT01545232|3054903|Superiority or Other||Risk Difference (RD)|2.8|||||2-Sided|95.0|-2.8|8.3|||||||
1660649|NCT01545232|3054904|Superiority or Other|||||||0.11|||||||van Elteren's test for medians||||
1660650|NCT01545232|3054906|Superiority or Other|||||||0.44|||||||van Elteren's test for medians||||
1660651|NCT01545232|3054907|Superiority or Other|||||||0.83|||||||van Elteren's test for medians||||
1660652|NCT01545232|3054909|Superiority or Other||Adjusted Relative Risk|0.86||||0.26|2-Sided|95.0|0.65|1.12|||Mantel Haenszel|The critical level for significance (p<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.||Initial sample size of 580 planned to detect clinically meaningful a 12% difference in 30-day mortality (23% vs. 35%),supported by prior data. DSMB increased sample size to 680 according to trial’s adaptive design. With 680 patients & given final observed mortality proportions in the 1:1:1 group, PROPPR had 92% power to detect the pre-specified 12% difference at 30 days, if such differences existed.|
1660653|NCT01545232|3054910|Superiority or Other||Adjusted Relative Risk|0.75||||0.12|2-Sided|95.0|0.52|1.08|||Mantel Haenszel|The critical level for significance (p<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests.||Initial sample size (580) planned to detect a clinically meaningful 10% difference in 24-hour mortality (11% vs. 21%) supported by prior data. Data Safety Monitoring Board (DSMB) increased sample size to 680 according to trial’s adaptive design. With 680 pts. & given the final observed mortality proportions in 1:1:1 group, PROPPR had 95% power to detect the pre-specified 10% difference at 24 hours if such differences existed.|
1660654|NCT01545076|3054935|Other||Median Difference (Net)|5.0|||<|0.001|2-Sided|95.0|2.0|9.0|||Wilcoxon rank sum||||
1660655|NCT01545076|3054935|Other||Median Difference (Net)|3.0|||=|0|2-Sided|95.0|0.0|9.0|||Wilcoxon rank sum||||
1660656|NCT01545076|3054936|Other||Median Difference (Final Values)|2.0|||=|0|2-Sided|95.0|1.0|4.0|||Wilcoxon rank sum||||
1660657|NCT01545076|3054936|Other||Median Difference (Final Values)|2.0|||=|0|2-Sided|95.0|1.0|4.0|||Wilcoxon rank sum||||
1660658|NCT01545076|3054937|Other||Median Difference (Net)|5.7|||=|0|2-Sided|95.0|0.7|11.7|||Wilcoxon rank sum||||
1660659|NCT01545076|3054937|Other||Median Difference (Net)|7.6|||=|0|2-Sided|95.0|2.0|14.0|||Wilcoxon rank sum||||
1660660|NCT01545076|3054938|Other||Median Difference (Net)|-1.0|||<|0.001|2-Sided|95.0|-1.0|0.0|||Wilcoxon rank sum||||
1660661|NCT01545076|3054938|Other||Median Difference (Net)|0.0|||=|0|2-Sided|95.0|-1.0|0.0|||Wilcoxon rank sum||||
1660662|NCT01545076|3054939|Superiority||Difference in Percent|-30.4|||<|0.001|2-Sided|95.0|-46.0|-12.2|||Fisher Exact||||
1660663|NCT01545076|3054939|Superiority||Difference in Percent|-24.6|||=|0|2-Sided|95.0|-40.7|-6.21|||Fisher Exact||||
1660664|NCT01544998|3054940|Superiority||||||<|0.001|||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.|
1660665|NCT01544998|3054941|Superiority||||||<|0.001|||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.|
1660666|NCT01544998|3054942|Superiority|||||||0.14|||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.|
1660667|NCT01544998|3054943|Superiority|||||||0.003|||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.|
1660668|NCT01544998|3054944|Superiority or Other|||||||0.9|||||||t-test, 2 sided|||This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.|
1660669|NCT01544998|3054945|Superiority or Other|||||||0.26|||||||t-test, 2 sided|||This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.|
1660670|NCT01544920|3054946|Non-Inferiority or Equivalence|The observed lower bound of the 95% CI for the difference was 2.5% (which exceeds 0) for BOC added to peg-IFN + RBV in contrast to peg-IFN + RBV alone.|Difference in SVR24%|10.3|||||2-Sided|95.0|2.5|18.1|||||||
1660671|NCT01544920|3054947|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower bound of the 95% CI of the difference in SVR24 % exceeded -10%.|Difference in SVR24% in Arm 2 vs. Arm 1|1.7|||||2-Sided|95.0|-3.2|6.5||||||Difference in percentage of participants achieving SVR24|
1660672|NCT01544595|3054969|Superiority|"H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68~• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68"|Hazard Ratio (HR)|0.2|||<|0.0001|2-Sided|95.0|0.14|0.29|||Log Rank|||"The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~H1: p1(t) – p0,1(t) = 0 versus HA1: p1(t)– p0,1(t) ≥ 0,~H2: p2(t) – p0,2(t) = 0 versus HA2: p2(t) – p0,2(t) ≥ 0,"|
1660673|NCT01544595|3054969|Superiority|"H1: Secukinumab 150 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68~• H2: Secukinumab 300 mg was not different from placebo with respect to the cumulative rate for patients who lost PASI 75 response up to Week 68"|Hazard Ratio (HR)|0.3|||<|0.0001|2-Sided|95.0|0.22|0.42|||Log Rank|||"The following hypotheses were tested for 52 weeks≤ t ≤68 weeks~H1: p1(t) – p0,1(t) = 0 versus HA1: p1(t)– p0,1(t) ≥ 0,~H2: p2(t) – p0,2(t) = 0 versus HA2: p2(t) – p0,2(t) ≥ 0,"|
1660674|NCT01544491|3054995|Non-Inferiority|KM estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood’s formula.|Mean Difference (Final Values)|0.8|Standard Error of the Mean|4.95||0.8642|2-Sided|80.0|-5.5|7.2|||t-test, 2 sided|||36 months|
1660675|NCT01544491|3054995|Non-Inferiority|KM estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood’s formula.|Mean Difference (Net)|5.0|Standard Error of the Mean|5.26||0.3455|2-Sided|80.0|-1.8|11.8|||t-test, 2 sided|||at 12 months|
1660676|NCT01544491|3054996|Non-Inferiority|Kaplan-Meier estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood’s formula.|Mean Difference (Final Values)|0.2|Standard Error of the Mean|5.84||0.9634|2-Sided|80.0|-7.3|7.7|||Log Rank|||36 months|
1660677|NCT01544491|3054996|Non-Inferiority|Kaplan-Meier estimates and between treatment differences are estimated using the Kaplan-Meier product-limit formula and 80% confidence intervals derived using standard errors estimated from Greenwood’s formula.|Mean Difference (Final Values)|0.1|Standard Error of the Mean|5.25||0.9712|2-Sided|80.0|-6.6|6.8|||Log Rank|||at 12 months|
1660678|NCT01544179|3055022|Superiority or Other (legacy)||Hazard Ratio (HR)|0.89||||0.437|2-Sided|95.0|0.66|1.2|||Cox Proportional Hazards||||
1660679|NCT01544179|3055023|Superiority or Other (legacy)||Odds Ratio (OR)|1.01||||0.959|2-Sided|95.0|0.61|1.68|||Regression, Logistic||||
1660680|NCT01544179|3055024|Superiority or Other (legacy)||Hazard Ratio (HR)|0.92||||0.575|2-Sided|95.0|0.69|1.23|||Cox Proportional Hazards||||
1660681|NCT01544179|3055025|Superiority or Other (legacy)||Odds Ratio (OR)|0.91||||0.725|2-Sided|95.0|0.54|1.53|||Regression, Logistic||||
1660682|NCT01544179|3055026|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.507|2-Sided|95.0|0.68|1.21|||Cox Proportional Hazards||||
1660683|NCT01544179|3055027|Superiority or Other (legacy)||Odds Ratio (OR)|0.92||||0.77|2-Sided|95.0|0.53|1.59|||Regression, Logistic||||
1660684|NCT01544179|3055028|Superiority or Other (legacy)||Odds Ratio (OR)|1.39||||0.308|2-Sided|95.0|0.74|2.62|||Regression, Logistic||||
1660685|NCT01544179|3055029|Superiority or Other (legacy)||Odds Ratio (OR)|0.92||||0.76|2-Sided|95.0|0.55|1.55|||Regression, Logistic||||
1660686|NCT01544179|3055030|Superiority or Other (legacy)||Hazard Ratio (HR)|1.62||||0.029|2-Sided|95.0|1.05|2.52|||Cox Proportional Hazards||||
1660687|NCT01544179|3055033|Superiority or Other (legacy)||Hazard Ratio (HR)|0.86||||0.273|2-Sided|95.0|0.65|1.13|||Cox Proportional Hazards||||
1660688|NCT01544127|3055077|Superiority||Cox Proportional Hazard|0.29|Standard Error of the Mean|0.23||0.1|2-Sided|95.0|0.06|1.43||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||"MI-SI-R + TAU vs. MI-SI + TAU~Because the impact of MI-SI + TAU and MI-SI-R + TAU were in different directions when compared to TAU Alone, they were compared. For this analysis, the null hypothesis was that the revisions did not change the impact of MI-SI + TAU."|
1660689|NCT01544127|3055077|Superiority||Cox Proportional Hazard|0.49|Standard Error of the Mean|0.39||0.24|2-Sided|95.0|0.1|2.31||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||MI-SI-R vs. TAU Alone|
1660690|NCT01544127|3055077|Superiority||Cox Proportional Hazard|1.69|Standard Error of the Mean|0.91||0.31|2-Sided|95.0|0.59|4.88||A priori, p was set at 0.01 for multiple comparisons.|Log Rank|||MI-SI + TAU vs. TAU Alone|
1660691|NCT01544127|3055078|Superiority||Odds Ratio (OR)|0.68|Standard Error of the Mean|0.38||0.5|2-Sided|95.0|0.23|2.06||A priori, p was set at 0.01 for multiple comparisons.|Regression, Logistic|||MI-SI-R + TAU vs. TAU Alone|
1660692|NCT01544127|3055078|Superiority||Odds Ratio (OR)|1.03|Standard Error of the Mean|0.65||0.96|2-Sided|0.95|0.3|3.54||A priori, p was set at 0.01 for multiple comparisons.|Regression, Logistic|||MI-SI + TAU vs. TAU Alone|
1660693|NCT01544127|3055079|Superiority||Beta|0.01|Standard Error of the Mean|0.13||0.46|2-Sided|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||MI-SI-R vs. TAU Alone|
1660694|NCT01544127|3055079|Superiority||Beta|0.09|Standard Error of the Mean|0.12||0.23|2-Sided|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||MI-SI vs. TAU Alone|
1660695|NCT01544127|3055079|Superiority||Beta|0.06|Standard Error of the Mean|0.11||0.3|2-Sided|||||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|A robust standard error clustered on participants was used.||"MI-SI + TAU vs. MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence/absence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the severity of suicidal ideation among participants with suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group."|
1660753|NCT01543685|3055174|Superiority or Other|||||||0.015|||||||t-test, 2 sided||||
1660754|NCT01543685|3055174|Superiority or Other|||||||0.004|||||||t-test, 2 sided||||
1660755|NCT01543685|3055174|Superiority or Other|||||||0.004|||||||t-test, 2 sided||||
1660756|NCT01543685|3055174|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1660696|NCT01544127|3055080|Superiority||Odds Ratio (OR)|0.59|Standard Error of the Mean|0.22||0.08|2-Sided|95.0|0.28|1.24||A priori, analyses were proposed as one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|MI-SI-R + TAU vs. TAU Alone|
1660697|NCT01544127|3055080|Superiority||Odds Ratio (OR)|0.6|Standard Error of the Mean|0.26||0.12|2-Sided|95.0|0.26|1.4||A priori, analyses were proposed as one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|MI-SI+TAU vs. TAU Alone|
1660698|NCT01544127|3055080|Superiority||Odds Ratio (OR)|0.59|Standard Error of the Mean|0.19||0.054|2-Sided|95.0|0.31|1.12||A priori, analyses were proposed to be one-sided, with p set at 0.05.|Zero-Inflated Poisson|Analysis adjusted for severity of worst TBI experience and used a robust standard error that was clustered on participants.|OR was calculated for number of participants with suicidal ideation. Analyses were one-sided, but two-sided confidence intervals for the OR are reported.|"MI-SI + TAU and MI-SI-R + TAU vs. TAU Alone~A hurdle model was used to examine the effect of the experimental interventions on the presence of suicidal ideation and the severity of suicidal ideation among those with it. These analyses examined the presence of suicidal ideation in the combined MI-SI + TAU and MI-SI-R + TAU treatment group."|
1660699|NCT01544062|3055091|Superiority or Other|||||||1|||||||Fisher Exact||||
1660700|NCT01544062|3055092|Superiority or Other|||||||0.455|||||||Fisher Exact||||
1660701|NCT01544062|3055093|Superiority or Other|||||||0.492|||||||Fisher Exact||||
1660702|NCT01544062|3055094|Superiority or Other|||||||1|||||||Fisher Exact||||
1660703|NCT01544062|3055095|Superiority or Other|||||||0.299|||||||Fisher Exact||||
1660704|NCT01544062|3055096|Superiority or Other|||||||1|||||||Fisher Exact||||
1660705|NCT01544062|3055097|Superiority or Other|||||||0.501|||||||Fisher Exact||||
1660706|NCT01544062|3055098|Superiority or Other|||||||0.511|||||||Fisher Exact||||
1660707|NCT01544062|3055099|Superiority or Other|||||||0.619|||||||Fisher Exact||||
1660708|NCT01544062|3055100|Superiority or Other|||||||0.58|||||||Fisher Exact||||
1660709|NCT01544062|3055101|Superiority or Other|||||||0.104|||||||t-test, 2 sided||||
1660710|NCT01544062|3055102|Superiority or Other|||||||0.905||||||controlling for age, sex and body mass index|ANCOVA||||
1660711|NCT01544062|3055102|Superiority or Other|||||||0.508|||||||t-test, 2 sided||||
1660712|NCT01544062|3055103|Superiority or Other|||||||0.475||||||controlling for age, sex and body mass index|ANCOVA||||
1660713|NCT01544062|3055103|Superiority or Other|||||||0.71|||||||t-test, 2 sided||||
1660714|NCT01544062|3055104|Superiority or Other|||||||0.16||||||controlling for age, sex and body mass index|ANCOVA||||
1660715|NCT01544062|3055104|Superiority or Other|||||||0.644|||||||t-test, 2 sided||||
1660716|NCT01544062|3055105|Superiority or Other|||||||0.927||||||controlling for age, sex and body mass index|ANCOVA||||
1660717|NCT01544062|3055105|Superiority or Other|||||||0.771|||||||t-test, 2 sided||||
1660718|NCT01544062|3055106|Superiority or Other|||||||0.395||||||controlling for age, sex and body mass index|ANCOVA||||
1660719|NCT01544062|3055106|Superiority or Other|||||||0.399|||||||t-test, 2 sided||||
1660720|NCT01544062|3055107|Superiority or Other|||||||0.509|||||||ANCOVA|controlling for age, sex and body mass index|||
1660721|NCT01544062|3055107|Superiority or Other|||||||0.6|||||||t-test, 2 sided||||
1660722|NCT01544062|3055108|Superiority or Other|||||||0.458||||||controlling for age, sex and body mass index|ANCOVA||||
1660723|NCT01544062|3055108|Superiority or Other|||||||0.397|||||||t-test, 2 sided||||
1660724|NCT01544062|3055109|Superiority or Other|||||||0.51||||||controlling for age, sex and body mass index|ANCOVA||||
1660725|NCT01544062|3055109|Superiority or Other|||||||0.724|||||||t-test, 2 sided||||
1660726|NCT01544062|3055110|Superiority or Other|||||||0.02||||||controlling for age, sex and body mass index|ANCOVA||||
1660727|NCT01544062|3055110|Superiority or Other|||||||0.059|||||||t-test, 2 sided||||
1660728|NCT01544062|3055111|Superiority or Other|||||||0.013||||||controlling for age, sex and body mass index|ANCOVA||||
1660729|NCT01544062|3055111|Superiority or Other||Mean Difference (Final Values)|16.7||||0.024|2-Sided|95.0|2.3|31.1|||t-test, 2 sided||||
1660730|NCT01543958|3055162|Superiority or Other|||||||0.62||||||Not adjusted for multiple comparisons|Sign test|no other adjustment|||
1660731|NCT01543958|3055163|Superiority or Other|||||||0.87||||||not adjusted for multiple comparisons|Sign test|no other adjustment|||
1660732|NCT01543776|3055165|Superiority|||||||0.012|||||||t-test, 2 sided||||
1660733|NCT01543776|3055166|Superiority|||||||0.26|||||||Fisher Exact||||
1660734|NCT01543776|3055167|Superiority|||||||0.13|||||||t-test, 2 sided||||
1660735|NCT01543776|3055168|Superiority|||||||0.38|||||||Log Rank||||
1660736|NCT01543776|3055169|Non-Inferiority|The above criteria for non-inferiority corresponds to a response rate in the low dose arm that is no more than 15% lower than the response rate in the high dose arm (i.e., non-inferiority margin of 15%), under the assumption that the log ratios are approximately normally distributed.|Mean Difference (Final Values)|0.3976|||<|0.1|1-Sided|90.0|-0.1111|||Calculated p-value.|t-test, 1 sided||||
1660737|NCT01543685|3055170|Superiority or Other|||||||0.029|||||||t-test, 2 sided||||
1660738|NCT01543685|3055170|Superiority or Other|||||||0.012|||||||t-test, 2 sided||||
1660739|NCT01543685|3055170|Superiority or Other|||||||0.02|||||||t-test, 2 sided||||
1660740|NCT01543685|3055170|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1660741|NCT01543685|3055171|Superiority or Other|||||||0.017|||||||t-test, 2 sided||||
1660742|NCT01543685|3055171|Superiority or Other|||||||0.005|||||||t-test, 2 sided||||
1660743|NCT01543685|3055171|Superiority or Other|||||||0.008|||||||t-test, 2 sided||||
1660757|NCT01543685|3055175|Superiority or Other|||||||0.028|||||||t-test, 2 sided||||
1660758|NCT01543685|3055175|Superiority or Other|||||||0.017|||||||t-test, 2 sided||||
1660759|NCT01543685|3055175|Superiority or Other|||||||0.004|||||||t-test, 2 sided||||
1660760|NCT01543685|3055175|Superiority or Other|||||||0.001|||||||t-test, 2 sided||||
1660761|NCT01543685|3055176|Superiority or Other|||||||0.098|||||||t-test, 2 sided||||
1660762|NCT01543685|3055176|Superiority or Other|||||||0.211|||||||t-test, 2 sided||||
1660763|NCT01543685|3055176|Superiority or Other|||||||0.014|||||||t-test, 2 sided||||
1660764|NCT01543685|3055176|Superiority or Other|||||||0.013|||||||t-test, 2 sided||||
1660765|NCT01543685|3055177|Superiority or Other||Difference in Least Squares Mean|211.6|Standard Error of the Mean|129.6||0.103|2-Sided|95.0|-43.1|466.2|||ANCOVA||||
1660766|NCT01543685|3055177|Superiority or Other||Difference in Least Squares Mean|312.7|Standard Error of the Mean|130.4||0.017|2-Sided|95.0|56.6|568.9|||ANCOVA||||
1660767|NCT01543685|3055177|Superiority or Other||Difference in Least Squares Mean|260.2|Standard Error of the Mean|130.3||0.046|2-Sided|95.0|4.1|516.3|||ANCOVA||||
1660768|NCT01543685|3055177|Superiority or Other||Difference in Least Squares Mean|441.8|Standard Error of the Mean|129.6|<|0.001|2-Sided|95.0|187.1|696.5|||ANCOVA||||
1660769|NCT01543503|3055190|Superiority or Other||Mean Difference (Net)|-7.767|||<|0.001|2-Sided|95.0|-12.161|-3.372|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in Patient’s Global Assessment of Disease as dependent variable; therapy and treatment as fixed effects; Patient’s Global Assessment of Disease at baseline as covariates.|
1660770|NCT01543503|3055190|Superiority or Other||Mean Difference (Net)|-5.108|||<|0.01|2-Sided|95.0|-9.017|-1.2|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in Patient’s Global Assessment of Disease as dependent variable; therapy and treatment as fixed effects; Patient’s Global Assessment of Disease at baseline as covariates.|
1660771|NCT01543503|3055192|Superiority or Other||Mean Difference (Net)|-9.802|||<|0.001|2-Sided|95.0|-14.245|-5.36|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in participant’s VAS score as dependent variable; therapy and treatment as fixed effects; participant’s VAS score at baseline as covariates.|
1660772|NCT01543503|3055192|Superiority or Other||Mean Difference (Net)|-5.661|||<|0.009|2-Sided|95.0|-9.912|-1.411|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in participant’s VAS score as dependent variable; therapy and treatment as fixed effects; participant’s VAS score at baseline as covariates.|
1660773|NCT01543503|3055193|Superiority or Other||Mean Difference (Net)|-2.787||||0.168|2-Sided|95.0|-6.763|1.189|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in FACIT-F score as dependent variable; therapy and treatment as fixed effects; FACIT-F score at baseline as covariates.|
1660774|NCT01543503|3055193|Superiority or Other||Mean Difference (Net)|-3.893||||0.032|2-Sided|95.0|-7.457|-0.329|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in FACIT-F score as dependent variable; therapy and treatment as fixed effects; FACIT-F score at baseline as covariates.|
1660775|NCT01543503|3055194|Superiority or Other||Mean Difference (Net)|-0.164||||0.02|2-Sided|95.0|-0.301|-0.026|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in HAQ-DI as dependent variable; therapy and treatment as fixed effects; HAQ-DI at baseline as covariates.|
1660776|NCT01543503|3055194|Superiority or Other||Mean Difference (Net)|-0.146||||0.02|2-Sided|95.0|-0.269|-0.024|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in HAQ-DI as dependent variable; therapy and treatment as fixed effects; HAQ-DI at baseline as covariates.|
1660777|NCT01543503|3055198|Superiority or Other||||||<|0.001|||||||Log Rank||||
1660778|NCT01543503|3055202|Superiority or Other||Mean Difference (Net)|-10.237|||<|0.001|2-Sided|95.0|-14.13|-6.345|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Physician Global Assessment score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in Physician Global Assessment of Disease Activity as the dependent variable; therapy and treatment as fixed effects; Physician Global Assessment of Disease Activity at baseline as covariates.|
1660779|NCT01543503|3055202|Superiority or Other||Mean Difference (Net)|-9.03|||<|0.001|2-Sided|95.0|-12.655|-5.404|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for Physician Global Assessment score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in Physician Global Assessment of Disease Activity as the dependent variable; therapy and treatment as fixed effects; Physician Global Assessment of Disease Activity at baseline as covariates.|
1660780|NCT01543503|3055203|Superiority or Other||Mean Difference (Net)|-3.245||||0.027|2-Sided|95.0|-6.121|-0.37|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SDAI score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in SDAI as the dependent variable; therapy and treatment as fixed effects; SDAI at baseline as the covariate.|
1660781|NCT01543503|3055203|Superiority or Other||Mean Difference (Net)|-3.229||||0.014|2-Sided|95.0|-5.806|-0.652|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SDAI score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in SDAI as the dependent variable; therapy and treatment as fixed effects; SDAI at baseline as the covariate.|
1660782|NCT01543503|3055203|Superiority or Other||Mean Difference (Net)|-4.6|||<|0.001|2-Sided|95.0|-6.708|-2.492|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CDAI score at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in CDAI as the dependent variable; therapy and treatment as fixed effects; CDAI at baseline as the covariate.|
1660808|NCT01542307|3055313|Superiority or Other|||||||0.05|||||||Fisher Exact||||
1660809|NCT01542307|3055314|Superiority or Other|||||||0.38|||||||Wilcoxon (Mann-Whitney)||||
1660783|NCT01543503|3055203|Superiority or Other||Mean Difference (Net)|-3.475|||<|0.001|2-Sided|95.0|-5.481|-1.469|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CDAI score at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in CDAI the dependent variable; therapy and treatment as fixed effects; CDAI at baseline as the covariate.|
1660784|NCT01543503|3055204|Superiority or Other||Mean Difference (Net)|-1.216||||0.004|2-Sided|95.0|-2.039|-0.393|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for TJC at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in TJC as the dependent variable; therapy and treatment as fixed effects; TJC at baseline as the covariate.|
1660785|NCT01543503|3055204|Superiority or Other||Mean Difference (Net)|-0.62||||0.123|2-Sided|95.0|-1.408|0.169|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for TJC at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in TJC as the dependent variable; therapy and treatment as fixed effects; TJC at baseline as the covariate.|
1660786|NCT01543503|3055205|Superiority or Other||Mean Difference (Net)|-0.752||||0.002|2-Sided|95.0|-1.238|-0.267|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SJC at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in SJC, as the dependent variable; therapy and treatment as fixed effects; SJC, at baseline as the covariate.|
1660787|NCT01543503|3055205|Superiority or Other||Mean Difference (Net)|-0.576||||0.024|2-Sided|95.0|-1.078|-0.075|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for SJC at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in SJC as the dependent variable; therapy and treatment as fixed effects; SJC at baseline as the covariate.|
1660788|NCT01543503|3055206|Superiority or Other||Mean Difference (Net)|-1.116||||0.659|2-Sided|95.0|-6.074|3.842|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CRP at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in CRP as the dependent variable; therapy and treatment as fixed effects; CRP at baseline as the covariate.|
1660789|NCT01543503|3055206|Superiority or Other||Mean Difference (Net)|-6.673|||<|0.001|2-Sided|95.0|-10.271|-3.074|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for CRP at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in CRP as a dependent variable; therapy and treatment as fixed effects; CRP at baseline as the covariate.|
1660790|NCT01543503|3055207|Superiority or Other||Mean Difference (Net)|-12.648|||<|0.001|2-Sided|95.0|-15.419|-9.876|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for ESR at Week 52: Analysis is based on an ANCOVA model with change from baseline to 12 months in ESR, as the dependent variable; therapy and treatment as fixed effects; ESR at baseline as the covariate.|
1660791|NCT01543503|3055207|Superiority or Other||Mean Difference (Net)|-13.23|||<|0.001|2-Sided|95.0|-15.513|-10.947|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor for ESR at Week 24: Analysis is based on an ANCOVA model with change from baseline to 6 months in ESR as a dependent variable; therapy and treatment as fixed effects; ESR at baseline as the covariate.|
1660792|NCT01543503|3055208|Superiority or Other||Mean Difference (Net)|-0.91|||<|0.001|2-Sided|95.0|-1.204|-0.617|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor: Analysis is based on an ANCOVA model with change from baseline to 12 months in DAS28-ESR as dependent variable; therapy and treatment as fixed effects; DAS28-ESR at baseline as covariates.|
1660793|NCT01543503|3055209|Superiority or Other||Mean Difference (Net)|-0.851|||<|0.001|2-Sided|95.0|-1.112|-0.589|||ANCOVA|||Treatment Difference between Tocilizumab and TNF inhibitor: Analysis is based on an analysis of covariance (ANCOVA) model with change from baseline in DAS28-ESR at 24 weeks as dependent variable; therapy, site country, and treatment as fixed effects; DAS28-ESR at baseline as covariates.|
1660794|NCT01543204|3055238|Superiority or Other||Difference|10.0||||0.4505|2-Sided|95.0|-15.97|35.97|||Wald asymptotic test||||
1660795|NCT01543178|3055240|Superiority or Other|||||||0.0232||||||The a priori threshold for statistical significance was p < 0.05.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel method was adjusted for analysis center and time to recurrence during Maintenance Phase 1.||A worst case analysis was performed, in which patients with < 4 days of IBS symptom data in a given week were considered as non-responders for that week.|
1660796|NCT01542957|3055267|Superiority or Other||Slope|-0.01||||0.84|2-Sided|95.0|-0.14|0.12|||Mixed Models Analysis||||
1660797|NCT01542957|3055268|Superiority or Other||Slope|1.27|Standard Error of the Mean|0.53||0.21|2-Sided|95.0|-0.71|3.25|||Mixed Models Analysis||||
1660798|NCT01542957|3055269|Superiority or Other||Slope|-0.96|Standard Error of the Mean|0.69||0.6|2-Sided|95.0|-3.35|1.43|||Mixed Models Analysis||||
1660799|NCT01542788|3055272|Superiority or Other||Proportion difference|77.3|||<|0.001|2-Sided|95.0|71.0|83.6||P-value is from the Cochran-Mantel-Haenszel test stratified by randomization stratification factor for the superiority of SOF+RBV over placebo.|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% CI are calculated based on stratum-adjusted Mantel-Haenszel proportions.||
1660800|NCT01542788|3055273|Superiority or Other||Proportion difference|82.7|||||2-Sided|95.0|76.8|88.5|||||The difference in proportions between treatment groups and associated 95% CI are calculated based on stratum-adjusted Mantel-Haenszel proportions.||
1660801|NCT01542788|3055275|Superiority or Other||Proportion difference|77.3|||<|0.001|2-Sided|95.0|71.0|83.6||P-value is from the Cochran-Mantel-Haenszel test stratified by presence or absence of cirrhosis for the superiority of SOF+RBV over placebo.|Cochran-Mantel-Haenszel||The difference in proportions between treatment groups and associated 95% confidence interval (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.|A sample size of 180 subjects in the active group and 60 in the placebo group would provide 99% power to detect a difference between group SVR12 rates of 40% using a 2-sided continuity-corrected chi-square test at significance level of 0.05.|
1660802|NCT01542502|3055299|Superiority or Other|||||||0.87|||||||ANOVA||||
1660803|NCT01542502|3055300|Superiority or Other|||||||0.009|||||||ANOVA||||
1660804|NCT01542307|3055309|Superiority or Other|||||||0.16|||||||Fisher Exact||||
1660805|NCT01542307|3055310|Superiority or Other|||||||1|||||||Fisher Exact||||
1660806|NCT01542307|3055311|Superiority or Other|||||||0.004|||||||Fisher Exact||||
1660807|NCT01542307|3055312|Superiority or Other|||||||0.05|||||||Fisher Exact||||
1660810|NCT01542307|3055315|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)||||
1660811|NCT01542307|3055316|Superiority or Other|||||||0.674|||||||Wilcoxon (Mann-Whitney)||||
1660812|NCT01542034|3055330|Superiority or Other||||||<|0.001|||||||ANCOVA|Analysis of covariance (ANCOVA) model included treatment and Baseline PR-SMFIS total scale score.||If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was > 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.|
1660813|NCT01542034|3055331|Superiority or Other||Risk Ratio (RR)|8.541|||<|0.001|2-Sided|95.0|3.62|20.148|||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|If both primary endpoints were statistically significant, testing continued to the 2 secondary endpoints using the Bonferroni-Holm method. The smaller of the 2 p-values for the treatment difference was tested at the 0.025 level. If significant, testing proceeded for the remaining secondary endpoint at the 0.05 level. If the smaller p-value was > 0.025, the null hypothesis for the associated variable would not be rejected, and testing of the second endpoint would not proceed.|
1660814|NCT01542034|3055332|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH method stratified by pooled study center.||The primary analysis was satisfied if both null hypotheses (there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.|
1660815|NCT01542034|3055333|Superiority or Other||Risk Ratio (RR)|3.702|||<|0.001|2-Sided|95.0|2.808|4.88|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) method stratified by pooled study center.|A risk ratio greater than 1 favors deoxycholic acid injection treatment, and between 0 and 1 favors placebo.|The primary analysis was satisfied if both null hypotheses (there is no treatment difference in 1-grade or 2-grade response rate) were rejected in favor of the two-tailed alternative at the 0.05 level of significance for both primary efficacy endpoints, and the response rates were higher for the deoxycholic acid injection treatment group than the placebo group. Because both hypotheses must be rejected, the type I error was preserved when testing the primary endpoints.|
1660816|NCT01541917|3055346|Superiority or Other||Slope|0.005|Standard Error of the Mean|0.007||0.49|2-Sided|95.0|-0.009|0.018|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.|
1660817|NCT01541917|3055346|Superiority or Other||Slope|-0.002|Standard Error of the Mean|0.004||0.58|2-Sided|95.0|-0.01|0.01|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable|
1660818|NCT01541917|3055347|Superiority or Other||Slope|-0.004|Standard Error of the Mean|0.008||0.67|2-Sided|95.0|-0.02|0.013|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.|
1660819|NCT01541917|3055347|Superiority or Other||Slope|0.0316|Standard Error of the Mean|0.004|<|0.001|2-Sided|95.0|0.02|0.04|||Multilevel growth model|Adjusted for baseline values.|The parameter represents the average monthly change on the outcome variable since before group procedures were started|Multilevel growth model evaluating average change over time on the outcome variable|
1660820|NCT01541917|3055348|Superiority or Other||Slope|-0.009|Standard Error of the Mean|0.084||0.91|2-Sided|95.0|-0.174|0.155|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.|
1660821|NCT01541917|3055348|Superiority or Other||Slope|-0.1|Standard Error of the Mean|0.04||0.02|2-Sided|95.0|-0.18|-0.01|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable|
1660822|NCT01541917|3055349|Superiority or Other||Slope|-0.01|Standard Error of the Mean|0.02||0.63|2-Sided|95.0|-0.05|0.03|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.|
1660823|NCT01541917|3055349|Superiority or Other||Slope|0.12|Standard Error of the Mean|0.01|<|0.001|2-Sided|95.0|0.1|0.14|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since before group procedures were started|Multilevel growth model evaluating average change over time on the outcome variable|
1660843|NCT01540487|3055546|Superiority or Other||adjusted gMean ratio|102.5|||||2-Sided|90.0|92.2|113.9|||||||
1660844|NCT01540487|3055546|Superiority or Other||adjusted gMean ratio|94.6|||||2-Sided|90.0|85.4|104.8|||||||
1661244|NCT01529749|3056521|Superiority|||||||1|||||||Chi-squared, Corrected||||
1660824|NCT01541917|3055350|Superiority or Other||Slope|0.053|Standard Error of the Mean|0.101||0.59|2-Sided|95.0|-0.144|0.252|||Multilevel growth model|Adjusted for baseline values on the outcome variable|The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.|
1660825|NCT01541917|3055350|Superiority or Other||Slope|0.37|Standard Error of the Mean|0.05|<|0.001|2-Sided|95.0|0.27|0.46|||Multilevel growth model|Adjusted for baseline values.|The parameter represents the average monthly change on the outcome variable since before group procedures were started.|Multilevel growth model evaluating average change over time on the outcome variable|
1660826|NCT01541917|3055351|Superiority or Other||Slope|-0.014|Standard Error of the Mean|0.021||0.51|2-Sided|95.0|-0.055|0.027|||Multilevel growth model||The estimated parameter value represents the difference in the monthly change (since baseline) in the outcome variable attributed to being in the treatment group (web-based coping skills training) versus the control group (online disease education).|Multilevel linear growth modeling was used for analyses, with the time variable coded as months since randomization. All models included an adjustment for baseline group differences on the outcome variable.|
1660827|NCT01541917|3055351|Superiority or Other||Slope|-0.04|Standard Error of the Mean|0.01|<|0.001|2-Sided|95.0|-0.06|-0.02|||Multilevel growth model|Adjusted for baseline values|The parameter represents the average monthly change on the outcome variable since group procedures were initiated.|Multilevel growth model evaluating average change over time (regardless of group) on the outcome variable|
1660828|NCT01541215|3055503|Superiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 4: Change from baseline in BMI SDS after 26 weeks of treatment"|Treatment difference|-0.047|Standard Error of the Mean|0.055||0.392|2-Sided|95.0|-0.153|0.06|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.|
1660829|NCT01541215|3055504|Superiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 3: HbA1c < 7.0% after 26 weeks of treatment"|Treatment odds ratio|5.353|||<|0.001|2-Sided|95.0|2.105|13.615|||logistic regression model|||Missing data was imputed using pattern mixture model. For each imputed data set the binary response was analysed in a logistic regression model using a logit link with treatment and stratification group (gender*age group) as fixed factors and baseline HbA1c as covariate.The estimated treatment effects and confidence intervals were combined using Rubin´s formula.|
1660830|NCT01541215|3055505|Superiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 2: Change from baseline in FPG after 26 weeks of treatment"|Treatment difference|-1.878|Standard Error of the Mean|0.62||0.002|2-Sided|95.0|-3.093|-0.662|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for weeks 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.|
1660831|NCT01541215|3055506|Superiority|"Stepwise hierarchical testing procedure was applied for confirmatory endpoints:~Step 1: Primary analysis: change from baseline to week 26 in HbA1c~Superiority of liraglutide over placebo was to be concluded if the 95% confidence interval for the treatment difference for change from baseline in HbA1c (%) after 26 weeks of randomised treatment was entirely below 0%, implying that the two sided p-value was less than 5%."|Treatment difference|-1.058|Standard Error of the Mean|0.304|<|0.001|2-Sided|95.0|-1.653|-0.464|||Pattern Mixture Model|||Analysis using a pattern mixture model of observed data with missing observations imputed from the placebo arm based on multiple (x10.000) imputations. The data for week 26 were then analysed with an ANCOVA model containing treatment, sex and age group as fixed effects and baseline value as covariate. The estimated treatment differences and confidence intervals were combined using Rubins formula.|
1660832|NCT01540825|3055524|Superiority or Other||Slope|1.151|Standard Error of the Mean|0.0215|||2-Sided|95.0|1.108|1.1941|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope|This was non confirmatory testing (Single dose).Dose proportionality of BI 113608 (PIB) for AUC0-inf was analysed|
1660833|NCT01540825|3055525|Superiority or Other||Slope|1.1626|Standard Error of the Mean|0.0215|||2-Sided|95.0|1.1195|1.2057|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually Standard Error of the slope|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (PIB) for AUC 0− tz was analysed.|
1660834|NCT01540825|3055527|Superiority or Other||Slope|1.2472|Standard Error of the Mean|0.032|||2-Sided|95.0|1.1831|1.3112|||||Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. Standard Error of the mean is actually the Standard Error of the slope|This was non confirmatory testing (Single dose). Dose proportionality of BI 113608 (powder in bottle (PIB)) for Cmax was analysed.|
1660835|NCT01540773|3055530|Superiority|||||||0.04|||||||t-test, 2 sided||||
1660836|NCT01540773|3055531|Superiority|||||||0.01|||||||t-test, 2 sided||||
1660837|NCT01540487|3055543|Superiority or Other||adjusted gMean ratio|100.8|||||2-Sided|90.0|95.1|106.8|||||||
1660838|NCT01540487|3055543|Superiority or Other||adjusted gMean ratio|99.5|||||2-Sided|90.0|94.7|104.6|||||||
1660839|NCT01540487|3055544|Superiority or Other||adjusted gMean ratio|102.8|||||2-Sided|90.0|97.0|109.0|||||||
1660840|NCT01540487|3055544|Superiority or Other||adjusted gMean ratio|98.0|||||2-Sided|90.0|92.0|104.5|||||||
1660841|NCT01540487|3055545|Superiority or Other||adjusted gMean ratio|89.3|||||2-Sided|90.0|80.2|99.3|||||||
1660842|NCT01540487|3055545|Superiority or Other||adjusted gMean ratio|110.1|||||2-Sided|90.0|100.5|120.6|||||||
1660845|NCT01540487|3055547|Superiority or Other||adjusteg gMean ratio|103.0|||||2-Sided|90.0|96.2|110.1|||||||
1660846|NCT01540487|3055547|Superiority or Other||adjusted gMean ratio|97.0|||||2-Sided|90.0|90.6|103.8|||||||
1660847|NCT01540487|3055548|Superiority or Other||adjusted gMean ratio|111.4|||||2-Sided|90.0|100.4|123.5|||||||
1660848|NCT01540487|3055548|Superiority or Other||adjusted gMean ratio|101.9|||||2-Sided|90.0|95.4|109.0|||||||
1660849|NCT01540487|3055549|Superiority or Other||adjusted gMean ratio|100.8|||||2-Sided|90.0|95.1|106.8|||||||
1660850|NCT01540487|3055549|Superiority or Other||adjusted gMean ratio|99.5|||||2-Sided|90.0|94.7|104.5|||||||
1660851|NCT01540162|3055559|Superiority or Other||Risk Ratio (RR)|0.23||||0.05|2-Sided|95.0|0.05|0.73|||Chi-squared||||
1660852|NCT01540045|3055560|Superiority or Other|||||||0.022|||||||McNemar|||We divide dilutions in two groups and dichotomized the patients into high and low sensibility to bitter taste. (PERCEPTION)|
1660853|NCT01540045|3055561|Superiority or Other|||||||0.092|||||||McNemar|||for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.|
1660854|NCT01540045|3055562|Superiority or Other|||||||0.109|||||||McNemar|||for the paired analysis of taste acuity, we used Mc Nemar test for dividing into high and low sensibility to umami, bitter and sweet tastes.|
1660855|NCT01540045|3055563|Superiority or Other|||||||0.402|||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.|
1660856|NCT01540045|3055564|Superiority or Other|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.|
1660857|NCT01540045|3055565|Superiority or Other|||||||0.608|||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.|
1660858|NCT01540045|3055566|Superiority or Other|||||||0.312|||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.|
1660859|NCT01540045|3055567|Superiority or Other|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||change in status global of quality of life between > ó = compared to < umami recognition threshold after chemotherapy by EORT questionnaire|
1660860|NCT01540045|3055568|Superiority or Other|||||||0.24||||||clinically significant|Wilcoxon (Mann-Whitney)|||change in peripheral neuropathy scale of quality of life between > ó = compared to < umami recognition threshold after chemotherapy by EORT questionnaire|
1660861|NCT01540045|3055569|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1660862|NCT01540045|3055570|Superiority or Other|||||||0.068||||||clinically significant|Wilcoxon (Mann-Whitney)|||change in constipation scale of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire|
1660863|NCT01540045|3055570|Superiority or Other|||||||0.595||||||clinically significant|Wilcoxon (Mann-Whitney)|||change in appetite loss of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire|
1660864|NCT01540045|3055570|Superiority or Other|||||||0.213||||||clinically significant|Wilcoxon (Mann-Whitney)|||change in fatigue scale of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire|
1660865|NCT01540045|3055570|Superiority or Other|||||||0.009|||||||Wilcoxon (Mann-Whitney)|||change in emotional functioning of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire|
1660866|NCT01540045|3055570|Superiority or Other|||||||0.293||||||clinically significant|Wilcoxon (Mann-Whitney)|||change in functional role of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire|
1660867|NCT01540045|3055570|Superiority or Other|||||||0.889|||||||Wilcoxon (Mann-Whitney)|||change in status global of quality of life between ≤ compared to > umami recognition threshold after chemotherapy by EORT questionnaire|
1660868|NCT01540045|3055571|Superiority or Other|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.|
1660869|NCT01540045|3055573|Superiority or Other|||||||0.004|||||||t-test, 2 sided|||FAT consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy|
1660870|NCT01540045|3055573|Superiority or Other|||||||0.01|||||||t-test, 2 sided|||animal protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy|
1660871|NCT01540045|3055573|Superiority or Other|||||||0.015|||||||t-test, 2 sided|||protein consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds compared to < Sweet perception thresholds after chemotherapy|
1660872|NCT01540045|3055574|Superiority or Other|||||||0.607|||||||McNemar|||Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).|
1660873|NCT01540045|3055575|Superiority or Other|||||||0.118|||||||t-test, 2 sided||||
1660874|NCT01540045|3055576|Superiority or Other|||||||0.694|||||||t-test, 2 sided|||we evaluated lean body mass before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy|
1660875|NCT01540045|3055576|Superiority or Other|||||||0.671|||||||t-test, 2 sided|||we evaluated body fat before and after 2 cycles of cisplatin/paclitaxel based chemotheprapy|
1660876|NCT01540045|3055577|Superiority or Other|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.|
1660877|NCT01539642|3055591|Superiority or Other||Mean Difference (Final Values)|50.02|Standard Error of the Mean|15.25||0.001|2-Sided|95.0|19.89|80.14|||ANCOVA||||
1660878|NCT01539538|3055612|Superiority or Other||Difference in proportion|12.9||||0.007|2-Sided|95.0|||||t-test, 2 sided||||
1660879|NCT01539538|3055612|Non-Inferiority or Equivalence|Non-inferiority margin of - 15% for lower boundary of 95% confidence interval|difference in proportion|12.9|||<|0.001|2-Sided|95.0|3.69|22.11|||one-sided, z-test||||
1660880|NCT01539525|3055614|Superiority or Other||Odds Ratio (OR)|0.749||||0.49|2-Sided|95.0|0.205|2.732|||Regression, Logistic||Odds ratio estimate is for Motivational Interview- Computer vs. Treatment as Usual||
1660881|NCT01539525|3055614|Superiority or Other||Odds Ratio (OR)|1.258||||0.465|2-Sided|95.0|0.409|3.871|||Regression, Logistic|adjusted for stratifying variables- primary drug and pregnancy status|odds ratio estimate is for Motivational Interview- Nurse vs. Treatment as Usual||
1660882|NCT01539525|3055615|Superiority or Other||Odds Ratio (OR)|0.968||||0.99|2-Sided|95.0|0.579|1.617|||Regression, Logistic|adjusted for stratifying variables- primary substance and pregnancy status|Estimated odds ratio is for Motivational Interview- Computer vs. Treatment as Usual||
1660883|NCT01539525|3055615|Superiority or Other||Odds Ratio (OR)|0.931||||0.81|2-Sided|95.0|0.559|1.551|||Regression, Logistic|adjusted for stratifying variables- primary substance and pregnancy status|Estimated odds ratio is for Motivational Interview- Nurse vs. Treatment as Usual||
1660884|NCT01539525|3055616|Superiority or Other||Slope|0.012|Standard Error of the Mean|0.0005||0.01|2-Sided|95.0|0.002|0.021||P-value adjusted for multiple comparisons using Holm’s step-down multiple testing procedure. The a priori threshold for statistical significance was p < 0.025.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.|
1660885|NCT01539525|3055616|Superiority or Other||Slope|0.011|Standard Error of the Mean|0.005||0.031|2-Sided|95.0|0.001|0.022||P-value adjusted for multiple comparisons using Holm’s step-down multiple testing procedure. The a priori threshold for statistical significance was p < 0.05.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x quadratic time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.|
1660886|NCT01539525|3055616|Superiority or Other||Slope|-0.09|Standard Error of the Mean|0.034||0.008|2-Sided|95.0|-0.157|-0.023||P-value adjusted for multiple comparisons using Holm’s step-down multiple testing procedure. The a priori threshold for statistical significance was p < 0.025|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Computer vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.|
1660887|NCT01539525|3055616|Superiority or Other||Slope|-0.078|Standard Error of the Mean|0.034||0.038|2-Sided|95.0|-0.151|-0.004||P-value adjusted for multiple comparisons using Holm’s step-down multiple testing procedure. The a priori threshold for statistical significance was p < 0.05.|Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Estimated parameter is treatment x linear time interaction term coefficient- Motivational Interview- Nurse vs. Treatment as Usual|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.|
1660888|NCT01539525|3055616|Superiority or Other||Slope|0.005|Standard Error of the Mean|0.003||0.066|2-Sided|95.0|-0.0004|0.011|||Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Parameter estimated is the quadratic effect of time (in months)|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.|
1660889|NCT01539525|3055616|Superiority or Other||Slope|-0.078|Standard Error of the Mean|0.02|<|0.001|2-Sided|95.0|-0.118|-0.038|||Generalized Estimating Equation|adjusted for stratifying variables- primary substance and pregnancy status|Parameter estimated is the linear effect of time (in months)|Differences in days/month of primary substance use over time between treatment groups were examined using generalized estimating equations (GEE). We specified a negative binomial distribution to account for overdispersion in days/month of primary substance use, a log link function, and a first-order autoregressive working correlation structure. β coefficients were estimated using quasi-likelihood estimation methods and sandwich/empirical standard errors were calculated.|
1660890|NCT01539512|3055618|Superiority or Other||Hazard Ratio (HR)|0.28|||||2-Sided|95.0|0.11|0.69|||||||
1660891|NCT01539512|3055621|Superiority or Other||Hazard Ratio (HR)|0.18|||<|0.0001|2-Sided|95.0|0.1|0.32|||Log Rank|P-value is from stratified log-rank test, adjusted for randomization stratification factors.|||
1660892|NCT01539317|3055624|Superiority or Other||||||<|0.001||||||Each of 8 site comparisons had its own P-value and a value of <0.001 was the difference at the most tender sites|Wilcoxon (Mann-Whitney)||||
1660893|NCT01539317|3055625|Superiority or Other|||||||0.92|||||||Wilcoxon (Mann-Whitney)|||Partner|
1660894|NCT01539317|3055625|Superiority or Other|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Enjoyment|
1660895|NCT01539317|3055625|Superiority or Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Pain|
1660896|NCT01539317|3055625|Superiority or Other|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Orgasm|
1660897|NCT01539317|3055625|Superiority or Other|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Arousal (C)|
1660898|NCT01539317|3055625|Superiority or Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Arousal (L)|
1660899|NCT01539317|3055625|Superiority or Other|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||Arousal (S)|
1660900|NCT01539317|3055625|Superiority or Other|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Desire|
1660901|NCT01539317|3055626|Superiority or Other|||||||0.412|||||||Wilcoxon (Mann-Whitney)|||Phase III|
1660902|NCT01539317|3055626|Superiority or Other|||||||0.0149|||||||Wilcoxon (Mann-Whitney)|||Phase II: During Blinded 4 weeks|
1660903|NCT01539070|3055663|Superiority or Other||Mean Difference (Final Values)|0.15|||<|0.05|2-Sided|95.0|-0.04|0.35|||Regression, Linear|||In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.|
1660904|NCT01539070|3055665|Superiority or Other||Mean Difference (Final Values)|-1.6|||<|0.05|2-Sided|95.0|-4.4|1.1|||Regression, Linear||The change in mean screen time between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.|
1660905|NCT01539070|3055665|Superiority or Other||Mean Difference (Final Values)|0.2|||<|0.05|2-Sided|95.0|-0.2|0.5|||Regression, Linear||The change in mean sleep time between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.|
1660906|NCT01539070|3055665|Superiority or Other||Mean Difference (Final Values)|-11.8|||<|0.05|2-Sided|95.0|-29.1|5.5|||Regression, Linear|All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season|The change in mean physical activity between the baseline measurement and 3 months, the intervention group compared with the control group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI) are reported.|
1660907|NCT01539070|3055666|Superiority or Other||Mean Difference (Final Values)|-2.2|||<|0.05|2-Sided|95.0|-8.4|4.1|||Regression, Linear||The change in the average added sugar in beverage consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.|
1660908|NCT01539070|3055666|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.05|2-Sided|95.0|-4.9|3.4|||Regression, Linear||The change in the average sugar-sweetened beverage consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.|
1660909|NCT01539070|3055666|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.05|2-Sided|95.0|-0.5|0.0|||Regression, Linear||The change in the average savory snacks consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.|
1660910|NCT01539070|3055666|Superiority or Other||Mean Difference (Final Values)|0.3|||<|0.05|2-Sided|95.0|-0.5|1.1|||Regression, Linear||The change in the average fast food consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.|
1660911|NCT01539070|3055666|Superiority or Other||Mean Difference (Final Values)|-3.9|||<|0.05|2-Sided|95.0|-8.9|1.1|||Regression, Linear||The change in the average sweet snacks consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.|
1661011|NCT01536119|3055952|Superiority or Other|||||||0.21|||||||Wilcoxon (Mann-Whitney)||||
1661012|NCT01536119|3055953|Superiority or Other|||||||0.12|||||||t-test, 2 sided||||
1660912|NCT01539070|3055666|Superiority or Other||Mean Difference (Final Values)|0.6|||<|0.05|2-Sided|95.0|-5.4|6.5|||Regression, Linear||The change in the average water consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.|
1660913|NCT01539070|3055666|Superiority or Other||Mean Difference (Final Values)|-1.6|||<|0.05|2-Sided|95.0|-13.6|10.3|||Regression, Linear||The change in the average fruit consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.|
1660914|NCT01539070|3055666|Superiority or Other||Mean Difference (Final Values)|6.3|||<|0.05|2-Sided|95.0|1.8|10.8|||Regression, Linear|All Regression models adjusted for clustering by clinic, child age, change in age, BMI z-score, maternal education and occupation, and season|The change in the average vegetable consumption from baseline to 3 months, the intervention group compared with the usual care group|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 months between the intervention and usual care groups. For continuous outcomes, we used linear regression models, and for dichotomous outcomes, we used logistic regression models. To account for clustering by practices, we performed generalized linear mixed models. The Estimator (Est) and Confidence Interval 95% (95% CI)are reported.|
1660915|NCT01538862|3055669|Superiority|||||||0.82|||||||Regression, Linear||||
1660916|NCT01538199|3055678|Superiority or Other|||||||0.02||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Two-tailed t-test measuring change in QIDS score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.|
1660917|NCT01538199|3055678|Superiority or Other|||||||0.01||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|One-tailed t-test to measure the change in QIDS score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after). One treatment completer in Group 1 was excluded because they consistently skipped several answers across self-rated scales for the duration of the study.|
1660918|NCT01538199|3055678|Superiority or Other|||||||0.18||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|Last observation carried forward (LOCF), one tailed t-test to compare change in QIDS score.|||
1660919|NCT01538199|3055681|Superiority or Other|||||||0.004|||||||t-test, 2 sided|||By means of a paired t-test we tested the significance of the change in the mean HAM-D17 total score (from baseline) to week 8. Although the primary comparison was with the last assessment (week 8). A last observation carried forward (LOCF) was also performed to account for one missing value at week 8.|
1660920|NCT01538199|3055681|Superiority or Other|||||||0.02||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Two-tailed t-test to compare the change in total severity score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).|
1660921|NCT01538199|3055681|Superiority or Other|||||||0.01||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|One-tailed t-test to compare the change in total severity score for treatment completers.||This analysis includes only treatment completers (participants who who were followed for the entire 8-week study period and who received a clinical assessment immediately after).|
1660922|NCT01538199|3055681|Superiority or Other|||||||0.08||||||a priori threshold for statistical significance: p≤0.05|t-test, 2 sided|Modified intent-to-treat approach with lost observation carried forward (LOCF) and a two-tailed t-test to compare the change in total severity score.|||
1660923|NCT01538199|3055681|Superiority or Other|||||||0.04||||||a priori threshold for statistical significance: p≤0.05|t-test, 1 sided|We used a modified intent-to-treat approach with LOCF and unpaired Student’s t-test (one-way), comparing the change in total severity score.|||
1660924|NCT01537835|3055695|Superiority or Other|||||||0.17||||||p-value is adjusted for multiple comparisons|Kruskal-Wallis||||
1660925|NCT01537432|3055708|Superiority or Other||difference in proportions|0.565|||<|0.001|2-Sided|95.0|0.363|0.768|||Fisher Exact||||
1660926|NCT01537393|3055712|Other|The primary analysis to assess the effect of PT on 3 year ECD was conducted with a mixed linear model adjusting for baseline ECD, corneal diagnosis, and potential confounders, including storage solution, preparation by eye bank vs surgeon, and accounting for correlated data from participants with 2 study eyes or 2 corneas from the same donor.|Mean Difference (Final Values)|73.0||||0.03|2-Sided|95.0|8.0|138.0|||Mixed Models Analysis|Adjusted for baseline ECD, diagnosis, storage solution, preparation by eye bank/surgeon, participants with 2 study eyes/ 2 corneas from the same donor|||
1660927|NCT01537393|3055713|Other|Confounding and treatment interactions were assessed in Cox proportional hazards regression models|Hazard Ratio (HR)|1.71||||0.02|2-Sided|95.0|1.09|2.71|||Regression, Cox|Unadjusted Hazard Ratio|||
1660928|NCT01537393|3055713|Non-Inferiority|The two treatment groups will be declared equivalent if the one-sided 95% confidence interval for the difference in proportions excludes the pre-defined non-inferiority limit of 4%.|Risk Difference (RD)|3.2|||||1-Sided|95.0||5.4|||||||The bootstrap re-sampling technique were used to account for potentially correlated data from donors who donated both corneas in this study and potentially correlated data from 2 study eyes of the same study participant. The technique will sample with replacement from the observed dataset. Confidence intervals will be calculated using the bias-corrected and accelerated method. The number of bootstraps will be 100,000.
1660929|NCT01537315|3055717|Superiority or Other|||||||0.4521||||||A paired comparison between baseline CRP values with values obtained after 1, 3, and 6 months of treatment was conducted, with a p-value of 0.05 used as the a priori threshold of statistical significance.|ANOVA||||
1660930|NCT01537120|3055744|Superiority or Other||Least Squares Mean Difference|-0.46|||||2-Sided|90.0|-0.62|-0.3|||||||
1660931|NCT01537120|3055745|Superiority or Other||Least Squares Mean Difference|-0.3|||||2-Sided|90.0|-0.36|-0.23|||||||
1660932|NCT01537120|3055746|Superiority or Other||Geometric Mean Ratio|0.91|||||2-Sided|90.0|0.85|0.96|||||||
1660933|NCT01537068|3055749|Superiority or Other||Chi-squared|6.32||||0.025|2-Sided||||||Chi-squared||||
1660934|NCT01537068|3055751|Superiority or Other||Test of Within-subjects effects|2.95||||0.09|2-Sided||||||Mixed Models Analysis|Repeated Measures of ANOVA|||
1660935|NCT01537042|3055766|Superiority or Other||Treatment Ratio|0.44||||0.0232|2-Sided|95.0|0.22|0.88|||ANCOVA|An analysis of covariance (ANCOVA) was performed for the log-transformed PLMI ratio with treatment and region as factors and Baseline as a covariate.|||
1660936|NCT01536951|3055771|Superiority or Other||LS mean difference|11.1|||||2-Sided|90.0|8.87|13.4|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.||
1660937|NCT01536951|3055771|Superiority or Other||LS mean difference|11.0|||||2-Sided|90.0|8.74|13.3|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.||
1660938|NCT01536951|3055771|Superiority or Other||LS mean difference|12.3|||||2-Sided|90.0|10.0|14.5|||||LS mean difference (moxifloxacin minus placebo) of change in QTcP at 1 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.||
1660939|NCT01536951|3055771|Superiority or Other||LS mean difference|0.963|||||2-Sided|90.0|-0.921|2.85|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 24 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.||
1660940|NCT01536951|3055771|Superiority or Other||LS mean difference|1.71|||||2-Sided|90.0|-0.182|3.6|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 12 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.||
1660941|NCT01536951|3055771|Superiority or Other||LS mean difference|-0.788|||||2-Sided|90.0|-2.68|1.1|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 6 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.||
1660942|NCT01536951|3055771|Superiority or Other||LS mean difference|0.702|||||2-Sided|90.0|-1.18|2.59|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 4 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.||
1660943|NCT01536951|3055771|Superiority or Other||LS mean difference|0.468|||||2-Sided|90.0|-1.42|2.35|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 3 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.||
1660944|NCT01536951|3055771|Superiority or Other||LS Mean Difference|1.44|||||2-Sided|90.0|-0.446|3.32|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 2 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.||
1660945|NCT01536951|3055771|Superiority or Other||LS mean difference|1.81|||||2-Sided|90.0|-0.079|3.69|||||LS mean difference (LY3009104 minus placebo) of change in QTcP at 1.5 h postdose was analyzed using an ANCOVA model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.||
1660946|NCT01536951|3055771|Superiority or Other||Least squares (LS) mean difference|0.239|||||2-Sided|90.0|-1.65|2.12|||||LS mean difference (LY3009104 minus placebo) of change in QTcP 1 h postdose analyzed using analysis of covariance (ANCOVA) model adjusted for baseline QTc, treatment, time, period, sequence, treatment-by-time, participant, and participant-by-period.||
1660947|NCT01536704|3055775|Superiority or Other||Median Difference (Final Values)|-0.0042||||0.537||95.0|||||Wilcoxon Signed Rank Test|This non-parametric analysis was performed on the unadjusted values of parameters.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.|
1660948|NCT01536704|3055775|Superiority or Other||Median Difference (Final Values)|0.0025||||0.5113||95.0|||||Wilcoxon Signed Rank Test|This non-parametric analysis was performed on the unadjusted values of parameters.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.|
1660949|NCT01536704|3055776|Superiority or Other||Mean Difference (Final Values)|0.0538||||0.4523||95.0|||||Wilcoxon Signed Rank Test|The value of T (1/2) was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.|
1660950|NCT01536704|3055776|Superiority or Other||Mean Difference (Final Values)|-0.0641||||0.5619||95.0|||||Wilcoxon Signed Rank Test|The value of T (1/2) was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.|
1660951|NCT01536704|3055777|Superiority or Other||Mean Difference (Final Values)|0.0005||||0.679||95.0|||||Wilcoxon Signed Rank Test|The value of Tmax was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.|
1660952|NCT01536704|3055777|Superiority or Other||Median Difference (Final Values)|0.0006||||0.1491||95.0|||||Wilcoxon Signed Rank Test|The value of Tmax was adjusted for this non-parametric analysis.|The median difference was calculated as Cherry minus Peppermint.|The null hypothesis considered that there is no median within-subject difference between two treatment groups.|
1660953|NCT01536704|3055778|Non-Inferiority or Equivalence|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|1.02|||||2-Sided|90.0|0.98|1.06|||||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.|
1660954|NCT01536704|3055778|Non-Inferiority or Equivalence|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-inf) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.92||||||90.0|0.88|0.95|||||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.|
1660955|NCT01536704|3055779|Non-Inferiority or Equivalence|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.97|||||2-Sided|90.0|0.93|1.02|||||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.|
1660956|NCT01536704|3055779|Non-Inferiority or Equivalence|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for Cmax lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.89|||||2-Sided|90.0|0.85|0.94|||||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.|
1660957|NCT01536704|3055780|Non-Inferiority or Equivalence|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|1.02|||||2-Sided|90.0|0.98|1.05|||||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.|
1660958|NCT01536704|3055780|Non-Inferiority or Equivalence|Bio-equivalence between two dosage treatments was concluded if the 90% confidence interval for the ratio of the means for AUC (0-t) lies within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.91|||||2-Sided|90.0|0.88|0.94|||||Geometric mean ratio of Cherry and Mint lozenge was determined by exponentiating least-squares means of log-transformed value.|The value was log-transformed and a linear mixed effects model was applied to this value, as the dependent variable, treatment, and period as fixed effects and participants as random effect.|
1660959|NCT01536587|3055814|Superiority or Other|||||||0.5062|||||||paired t-Test, 2-sided||||
1660960|NCT01536496|3055861|Superiority or Other|||||||0.04|||||||Chi-squared|||Chi-square test|
1660961|NCT01536418|3055866|Superiority or Other||Mean Difference (Final Values)|8.9|||||2-Sided|95.0|-1.0|18.7||||||CDAI score (Clinical response), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID at both Week 8 and Week 12|
1660962|NCT01536418|3055866|Superiority or Other||Mean Difference (Final Values)|5.0|||||2-Sided|95.0|-6.0|15.9||||||CDAI score (Clinical response), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID at Week 8|
1660963|NCT01536418|3055867|Superiority or Other||Mean Difference (Final Values)|2.4|||||2-Sided|95.0|-4.6|9.5||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at both Weeks 8 and 12|
1660964|NCT01536418|3055867|Superiority or Other||Median Difference (Final Values)|5.6|||||2-Sided|95.0|-3.0|14.3||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at Week 12|
1660965|NCT01536418|3055867|Superiority or Other||Mean Difference (Final Values)|2.5|||||2-Sided|95.0|-5.8|10.8||||||CDAI score (Clinical remission), GSK1605786A, 500 mg QD Vs GSK1605786A, 500 mg BID; at Week 8|
1660966|NCT01536418|3055868|Superiority or Other||Mean Difference (Final Values)|8.1|||||2-Sided|95.0|-3.0|19.3|||||||
1660967|NCT01536405|3055876|Superiority or Other||Risk Difference (RD)|0.2|||<|0.001|2-Sided|95.0|-1.0|1.3|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)||
1660968|NCT01536405|3055877|Non-Inferiority or Equivalence|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of >=1.5 fold|GMT ratio|1.0|||<|0.001|2-Sided|95.0|0.9|1.1|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)||
1660969|NCT01536405|3055878|Non-Inferiority or Equivalence|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of >=1.5 fold|GMT ratio|1.0|||<|0.001|2-Sided|95.0|0.9|1.1|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)||
1660970|NCT01536405|3055879|Non-Inferiority or Equivalence|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of >=1.5 fold|GMT ratio|0.9|||<|0.001|2-Sided|95.0|0.8|1.0|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)||
1660971|NCT01536405|3055880|Non-Inferiority or Equivalence|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the GMT ratio, excluding a decrease of >=1.5 fold|GMT ratio|1.2|||<|0.001|2-Sided|95.0|1.1|1.3|||t-test, 2 sided|Analysis was based on log-transformed titers|GMT ratio = MMRV (AMP) / MMRV (2006 process)||
1660972|NCT01536405|3055881|Superiority or Other||Response rate|98.8|||<|0.001|2-Sided|95.0|97.6|99.5|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being >90%|
1660973|NCT01536405|3055881|Non-Inferiority or Equivalence|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease >= the prespecified criterion of 5 percentage points|Risk Difference (RD)|-0.5|||<|0.001|2-Sided|95.0|-1.8|0.7|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)||
1661013|NCT01536119|3055954|Superiority or Other|||||||0.29|||||||Wilcoxon (Mann-Whitney)||||
1660974|NCT01536405|3055882|Superiority or Other||Response rate|98.2|||<|0.001|2-Sided|95.0|96.8|99.1|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being >90%|
1660975|NCT01536405|3055882|Non-Inferiority or Equivalence|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease >= the prespecified criterion of 5 percentage points|Risk Difference (RD)|1.0|||<|0.001|2-Sided|95.0|-0.7|2.8|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)||
1660976|NCT01536405|3055883|Superiority or Other||Response rate|96.7|||<|0.001|2-Sided|95.0|94.9|97.9|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being >90%|
1660977|NCT01536405|3055883|Non-Inferiority or Equivalence|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease >= the prespecified criterion of 5 percentage points|Risk Difference (RD)|-2.2|||<|0.003|2-Sided|95.0|-4.0|-0.6|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)||
1660978|NCT01536405|3055884|Superiority or Other||Response rate|97.3|||<|0.001|2-Sided|95.0|95.6|98.4|||One-sample binomial|||Acceptability of the antibody response rate was based on a lower bound of the 95% CI being >76%|
1660979|NCT01536405|3055884|Non-Inferiority or Equivalence|The non-inferiority evaluation is based on the lower bound of the 2-sided 95% confidence interval (CI) on the risk difference excluding a decrease >= the prespecified criterion of 10 percentage points|Risk Difference (RD)|4.2|||<|0.001|2-Sided|95.0|1.8|6.8|||Miettinen and Nurminen||RD = MMRV (AMP) - MMRV (2006 process)||
1660980|NCT01536379|3055885|Superiority or Other||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|2.225|||2-Sided|95.0|-4.84|3.96|||||||
1660981|NCT01536379|3055886|Superiority or Other||Mean Difference (Final Values)|-2.7|Standard Error of the Mean|8.315|||2-Sided|95.0|-19.11|13.72|||||Week 52 comparison||
1660982|NCT01536379|3055886|Superiority or Other||Mean Difference (Final Values)|-12.92|Standard Error of the Mean|9.44|||2-Sided|95.0|-31.56|5.71|||||Week 24 comparison||
1660983|NCT01536379|3055887|Superiority or Other||Mean Difference (Final Values)|-12.9|Standard Error of the Mean|47.52|||2-Sided|95.0|-107.1|81.4|||||Week 52 comparison||
1660984|NCT01536379|3055887|Superiority or Other||Mean Difference (Final Values)|-2.8|Standard Error of the Mean|52.06|||2-Sided|95.0|-105.9|100.3|||||Week 24 comparison||
1660985|NCT01536379|3055888|Superiority or Other||Difference in Proportion|-0.267|||||2-Sided|95.0|-0.838|0.305|||||Week 52 comparison||
1660986|NCT01536379|3055888|Superiority or Other||Difference in Proportion|-0.067|||||2-Sided|95.0|-0.638|0.505|||||Week 24 comparison||
1660987|NCT01536379|3055889|Superiority or Other||Mean Difference (Final Values)|-1.01|Standard Error of the Mean|1.329|||2-Sided|95.0|-3.68|1.67|||||Week 52 comparison||
1660988|NCT01536379|3055889|Superiority or Other||Mean Difference (Final Values)|-1.54|Standard Error of the Mean|1.255|||2-Sided|95.0|-4.07|0.98|||||Week 24 comparison||
1660989|NCT01536379|3055890|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|1.45|||2-Sided|95.0|-3.5|2.3|||||Week 52 comparison||
1660990|NCT01536379|3055890|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|1.67|||2-Sided|95.0|-3.2|3.5|||||Week 24 comparison||
1660991|NCT01536379|3055891|Superiority or Other||Mean Difference (Final Values)|-5618.9|Standard Error of the Mean|12153.03|||2-Sided|95.0|-29994.8|18757.0|||||Week 52 comparison||
1660992|NCT01536379|3055891|Superiority or Other||Mean Difference (Final Values)|648.3|Standard Error of the Mean|12618.44|||2-Sided|95.0|-24661.1|25957.7|||||Week 24 comparison||
1660993|NCT01536379|3055892|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|3.35|||2-Sided|95.0|-7.2|6.3|||||Week 52 comparison||
1660994|NCT01536379|3055892|Superiority or Other||Mean Difference (Final Values)|-3.0|Standard Error of the Mean|3.54|||2-Sided|95.0|-10.1|4.2|||||Week 24 comparison||
1660995|NCT01536379|3055893|Superiority or Other||Mean Difference (Final Values)|-46955.3|Standard Error of the Mean|32594.81|||2-Sided|95.0|-113218.9|19308.3|||||Week 52 comparison||
1660996|NCT01536379|3055893|Superiority or Other||Mean Difference (Final Values)|-30326.9|Standard Error of the Mean|34677.86|||2-Sided|95.0|-100559.1|39905.3|||||Week 24 comparison||
1660997|NCT01536379|3055894|Superiority or Other||Mean Difference (Final Values)|0.79|Standard Error of the Mean|1.017|||2-Sided|95.0|-1.24|2.82|||||Week 52 comparison||
1660998|NCT01536379|3055894|Superiority or Other||Mean Difference (Final Values)|-1.29|Standard Error of the Mean|1.156|||2-Sided|95.0|-3.59|1.01|||||Week 24 comparison||
1660999|NCT01536379|3055895|Superiority or Other||Mean Difference (Final Values)|-458.0|Standard Error of the Mean|4501.8|||2-Sided|95.0|-9487.0|8572.0|||||Week 52 comparison||
1661000|NCT01536379|3055895|Superiority or Other||Mean Difference (Final Values)|-2791.0|Standard Error of the Mean|4651.1|||2-Sided|95.0|-12105.0|6524.0|||||Week 24 comparison||
1661001|NCT01536379|3055896|Superiority or Other||Mean Difference (Final Values)|6.8|Standard Error of the Mean|7.68|||2-Sided|95.0|-8.6|22.2|||||Week 52 comparison||
1661002|NCT01536379|3055896|Superiority or Other||Mean Difference (Final Values)|-13.8|Standard Error of the Mean|8.78|||2-Sided|95.0|-31.3|3.7|||||Week 24 comparison||
1661003|NCT01536379|3055897|Superiority or Other||Mean Difference (Final Values)|-13128.35|Standard Error of the Mean|24165.18|||2-Sided|95.0|-61868.9|35612.2|||||Week 52 comparison||
1661004|NCT01536379|3055897|Superiority or Other||Mean Difference (Final Values)|1232.4|Standard Error of the Mean|25735.56|||2-Sided|95.0|-50457.0|52921.8|||||Week 24 comparison||
1661005|NCT01536379|3055898|Superiority or Other||Median Difference (Final Values)|-33.06|||||2-Sided|95.0|-169.84|25.0|||||Week 52 comparison||
1661006|NCT01536379|3055898|Superiority or Other||Median Difference (Final Values)|204.35|||||2-Sided|95.0|90.0|550.0|||||Week 24 comparison||
1661007|NCT01536379|3055919|Superiority or Other||Mean Difference (Final Values)|-34.4|Standard Error of the Mean|37.24|||2-Sided|95.0|-109.5|40.7|||||||
1661008|NCT01536197|3055928|Superiority or Other|||||||0.19|||||||ANOVA|Two-way ANOVAs with group (gastric bypass and lap banding) as the between-subjects factor and time (before after surgery).|||
1661009|NCT01536119|3055950|Superiority or Other|||||||0.43|||||||t-test, 2 sided||||
1661010|NCT01536119|3055951|Superiority or Other|||||||0.06|||||||t-test, 2 sided||||
1661014|NCT01536119|3055955|Superiority or Other|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||Brief scale used|
1661015|NCT01536119|3055956|Superiority or Other||Risk Ratio (RR)|1.1||||0.02||95.0|1.01|1.19|||Chi-squared||||
1661016|NCT01536119|3055957|Superiority or Other||Risk Ratio (RR)|1.06||||0.06||95.0|1.0|1.13|||Fisher Exact||||
1661017|NCT01536119|3055958|Superiority or Other||Risk Ratio (RR)|1.19||||0.09||95.0|0.98|1.44|||Chi-squared||||
1661018|NCT01536119|3055959|Superiority or Other||Risk Ratio (RR)|1.12||||0.27|2-Sided|95.0|0.91|1.38|||Chi-squared|||"Power analysis was conducted to a 15 % increase in exclusive breastfeeding rates (from 52% to 67%) with 80% power and an alpha of 0.05. A 25% attrition rate waas added. 107 couples were needed per group. Intention to treat analysis conducted.~Exclusive breastfeeding at 12 weeks"|
1661019|NCT01536093|3055971|Superiority or Other|||||||0.013|||||||Wilcoxon (Mann-Whitney)||||
1661020|NCT01536093|3055972|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1661021|NCT01536093|3055973|Superiority or Other|||||||0.038|||||||Wilcoxon (Mann-Whitney)||||
1661022|NCT01536093|3055974|Superiority or Other|||||||0.032|||||||Wilcoxon (Mann-Whitney)||||
1661023|NCT01536093|3055975|Superiority or Other|||||||0.043|||||||Wilcoxon (Mann-Whitney)||||
1661024|NCT01536093|3055976|Superiority or Other|||||||0.006|||||||Wilcoxon (Mann-Whitney)||||
1661025|NCT01535729|3055998|Superiority or Other||Hazard Ratio (HR)|1.882|Standard Error of the Mean|0.213||0.003|2-Sided|95.0|1.239|2.859|||Wald Chi-Squares|||Comparison between smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.|
1661026|NCT01535729|3055998|Superiority or Other||Hazard Ratio (HR)|1.935|Standard Error of the Mean|0.179||0|2-Sided|95.0|1.362|2.749|||Wald Chi-Squares|||Comparison between ex-smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.|
1661027|NCT01535729|3055999|Superiority or Other||Hazard Ratio (HR)|0.717|Standard Error of the Mean|0.15||0.027|2-Sided|95.0|0.535|0.962|||Wald Chi-Squares|||Comparison between female and male was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor gender.|
1661028|NCT01535729|3056002|Superiority or Other||Hazard Ratio (HR)|1.786|Standard Error of the Mean|0.183||0.002|2-Sided|95.0|1.248|2.557|||Wald Chi-Squares|||Comparison between smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.|
1661029|NCT01535729|3056002|Superiority or Other||Hazard Ratio (HR)|1.902|Standard Error of the Mean|0.156||0|2-Sided|95.0|1.402|2.582|||Wald Chi-Squares|||Comparison between ex-smoker and non-smoker was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor smoking.|
1661030|NCT01535729|3056003|Superiority or Other||Hazard Ratio (HR)|0.732|Standard Error of the Mean|0.129||0.015|2-Sided|95.0|0.569|0.941|||Wald Chi-Squares|||Comparison between female and male was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor gender.|
1661031|NCT01535729|3056004|Superiority or Other||Hazard Ratio (HR)|1.162|Standard Error of the Mean|0.212||0.479|2-Sided|95.0|0.767|1.759|||Wald Chi-Squares|||Comparison between ≥ 80 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.|
1661032|NCT01535729|3056004|Superiority or Other||Hazard Ratio (HR)|0.689|Standard Error of the Mean|0.162||0.022|2-Sided|95.0|0.501|0.947|||Wald Chi-Squares|||Comparison between 75-79 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.|
1661033|NCT01535729|3056004|Superiority or Other||Hazard Ratio (HR)|0.981|Standard Error of the Mean|0.143||0.895|2-Sided|95.0|0.741|1.299|||Wald Chi-Squares|||Comparison between 70-74 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.|
1661034|NCT01535729|3056019|Superiority or Other||Hazard Ratio (HR)|1.054|Standard Error of the Mean|0.242||0.829|2-Sided|95.0|0.656|1.692|||Wald Chi-Squares|||Comparison between ≥ 80 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.|
1661035|NCT01535729|3056019|Superiority or Other||Hazard Ratio (HR)|0.744|Standard Error of the Mean|0.185||0.11|2-Sided|95.0|0.518|1.07|||Wald Chi-Squares|||Comparison between 75-79 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.|
1661036|NCT01535729|3056019|Superiority or Other||Hazard Ratio (HR)|0.949|Standard Error of the Mean|0.167||0.756|2-Sided|95.0|0.684|1.318|||Wald Chi-Squares|||Comparison between 70-74 years and 65-69 years was reported. Parameter estimates, standard errors, Wald Chi-Squares, p-values, hazard ratios and confidence limits were based on a univariate Cox regression with factor age.|
1661037|NCT01535664|3056021|Superiority or Other||Difference in least square means|-2.38|Standard Error of the Mean|2.97||0.434|2-Sided|95.0|-8.6|3.84||A step-down procedure using the primary statistical analysis was followed. If the p-value for the overall gait was less than 0.05, then overall balance was tested in the same manner. Otherwise, the testing procedure was stopped.|Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment||The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall balance was a weighted average of SOT, LOS, and ADT.|
1661038|NCT01535664|3056022|Superiority or Other||Difference in least square means|0.36|Standard Error of the Mean|0.08|<|0.001|2-Sided|95.0|0.19|0.54|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment|||
1661233|NCT01529749|3056510|Superiority|||||||0.49|||||||Chi-squared, Corrected||||
1661234|NCT01529749|3056511|Superiority|||||||1|||||||Chi-squared, Corrected||||
1661039|NCT01535664|3056023|Superiority or Other||Difference in least square means|7.729|Standard Error of the Mean|2.495||0.006|2-Sided|95.0|2.507|12.95|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment|||
1661040|NCT01535664|3056024|Superiority or Other||Difference in least square means|1.7|Standard Error of the Mean|0.5||0.003|2-Sided|95.0|0.7|2.8|||Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment|||
1661041|NCT01535664|3056025|Superiority or Other||Difference in least square means|4.04|Standard Error of the Mean|1.51||0.015|2-Sided|95.0|0.87|7.2||A step-down procedure using the primary statistical analysis was followed. If the p-value for the overall gait was less than 0.05, then overall balance was tested in the same manner. Otherwise, the testing procedure was stopped.|Mixed Models Analysis|P-value is based on a mixed model ANOVA with a fixed effect for treatment.||The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores). Overall gait was the average of WA, TW, and SQT; a higher score is indicative of better performance.|
1661042|NCT01535638|3056026|Superiority or Other||Ratio (%)|107.6|Standard Deviation|35.0|||2-Sided|90.0|83.1|139.4|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation modified (test) and Deleobuvir Final Formulation (reference) in pairwise comparison. (test : reference)|
1661043|NCT01535638|3056026|Superiority or Other||Ratio (%)|122.5|Standard Deviation|16.1|||2-Sided|90.0|107.9|139.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation (test) and Deleobuvir Trial Formulation II (reference) in pairwise comparison. (test : reference)|
1661044|NCT01535638|3056027|Superiority or Other||Ratio (%)|109.8|Standard Deviation|28.8|||2-Sided|90.0|88.6|136.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|relative bioavailability comparison of Deleobuvir Final Formulation modified (test) and Deleobuvir Final Formulation (reference) in pairwise comparison. (reference : test)|
1661045|NCT01535638|3056027|Superiority or Other||Ratio (%)|123.4|Standard Deviation|17.1|||2-Sided|90.0|108.0|141.1|||||The estimate of the relative bioavailability (%) is adjusted for the period effects in the ANOVA. The standard deviation is actually the gCV. CIs are based on the residual error from ANOVA, considering only the data from the 2 compared treatments.|Relative bioavailability comparison of Deleobuvir Trial Formulation II (reference) and Deleobuvir Final Formulation (test) in pairwise comparison. (reference : test)|
1661046|NCT01535443|3056045|Other|||||||0.374|||||||Traza Pillai|The test was performed with degrees of freedom: 2|||
1661047|NCT01535235|3056067|Superiority or Other|||||||0.63|||||||Wilcoxon (Mann-Whitney)||||
1661048|NCT01535235|3056068|Superiority or Other|||||||0.63|||||||Wilcoxon (Mann-Whitney)||||
1661049|NCT01535014|3056087|Superiority|||||||0.98|||||||ANCOVA|||SF-36 Physical Health Domain|
1661050|NCT01535014|3056087|Superiority|||||||0.6|||||||ANCOVA|||SF-36 Physical Health Domain|
1661051|NCT01535014|3056087|Superiority|||||||0.63|||||||ANCOVA|||SF-36 Mental Health Domain|
1661052|NCT01535014|3056087|Superiority|||||||0.02|||||||ANCOVA|||SF-36 Mental Health Domain|
1661053|NCT01535014|3056088|Superiority|||||||0.75|||||||ANCOVA||||
1661054|NCT01535014|3056088|Superiority|||||||0.2|||||||ANCOVA||||
1661055|NCT01535014|3056089|Superiority|||||||0.043|||||||ANCOVA||||
1661056|NCT01535014|3056089|Superiority|||||||0.019|||||||ANCOVA||||
1661057|NCT01535014|3056090|Superiority||||||<|0.05||||||For week 16, 20, 24|Chi-squared||||
1661058|NCT01535014|3056090|Superiority||||||<|0.05||||||For week 12, 16, 20, 24|Chi-squared||||
1661059|NCT01535014|3056091|Superiority|||||||0.07|||||||t-test, 2 sided||||
1661060|NCT01535014|3056091|Superiority|||||||0.03|||||||t-test, 2 sided||||
1661061|NCT01535014|3056092|Superiority|||||||0.07|||||||t-test, 2 sided||||
1661062|NCT01535014|3056092|Superiority|||||||0.03|||||||t-test, 2 sided||||
1661063|NCT01535014|3056093|Superiority|||||||0.0007|||||||Cochran-Mantel-Haenszel||||
1661064|NCT01535014|3056093|Superiority|||||||0.004|||||||Chi-squared||||
1661065|NCT01535014|3056093|Superiority|||||||0.04|||||||Chi-squared||||
1661066|NCT01534689|3056117|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||results at 12 weeks compared to baseline|
1661067|NCT01534689|3056118|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1661068|NCT01534533|3056127|Superiority or Other|||||||0.636||||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"|
1661069|NCT01534533|3056128|Superiority or Other|||||||0.402||||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"|
1661070|NCT01534533|3056129|Superiority or Other|||||||0.672||||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"|
1661071|NCT01534533|3056130|Superiority or Other|||||||0.992||||||The a priori threshold for statistical significance was 0.05 (two sides)|ANOVA|||"The null hypothesis was no group difference"|
1661072|NCT01534533|3056131|Superiority or Other||||||>|0.05||||||The a priori threshold for statistical significance was 0.05 (two sides)|Chi-squared|||"The null hypothesis was no group difference"|
1661073|NCT01533935|3056202|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|0.018|<|0.0001|2-Sided|95.0|0.076|0.146|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD||
1661074|NCT01533935|3056202|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.018|<|0.0001|2-Sided|95.0|0.075|0.145|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD||
1661235|NCT01529749|3056512|Superiority|||||||1|||||||Chi-squared, Corrected||||
1661075|NCT01533935|3056202|Superiority or Other||Mean Difference (Final Values)|0.305|Standard Error of the Mean|0.018|<|0.0001|2-Sided|95.0|0.269|0.34|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD||
1661076|NCT01533935|3056202|Superiority or Other||Mean Difference (Final Values)|0.135|Standard Error of the Mean|0.018|<|0.0001|2-Sided|95.0|0.1|0.17|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD||
1661077|NCT01533935|3056202|Superiority or Other||Mean Difference (Final Values)|0.134|Standard Error of the Mean|0.018|<|0.0001|2-Sided|95.0|0.099|0.169|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD||
1661078|NCT01533935|3056202|Superiority or Other||Mean Difference (Final Values)|0.329|Standard Error of the Mean|0.018|<|0.0001|2-Sided|95.0|0.294|0.364|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD||
1661079|NCT01533935|3056203|Superiority or Other||Mean Difference (Final Values)|-0.001|Standard Error of the Mean|0.001||0.1206|2-Sided|95.0|-0.002|0.0|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD||
1661080|NCT01533935|3056203|Superiority or Other||Mean Difference (Final Values)|-0.002|Standard Error of the Mean|0.001||0.001|2-Sided|95.0|-0.004|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD||
1661081|NCT01533935|3056203|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.001|<|0.0001|2-Sided|95.0|-0.005|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD||
1661082|NCT01533935|3056203|Superiority or Other||Mean Difference (Final Values)|-0.001|Standard Error of the Mean|0.001|<|0.2306|2-Sided|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD||
1661083|NCT01533935|3056203|Superiority or Other||Mean Difference (Final Values)|-0.002|Standard Error of the Mean|0.001|<|0.0033|2-Sided|95.0|-0.003|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD||
1661084|NCT01533935|3056203|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.001|<|0.0001|2-Sided|95.0|-0.004|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD||
1661085|NCT01533935|3056204|Superiority or Other||Ratio|1.032|Standard Error of the Mean|0.033||0.324|2-Sided|95.0|0.97|1.098|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Tiotropium 5 mcg QD||
1661086|NCT01533935|3056204|Superiority or Other||Ratio|1.099|Standard Error of the Mean|0.035||0.0029|2-Sided|95.0|1.033|1.17|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Olodaterol 5 mcg QD||
1661087|NCT01533935|3056204|Superiority or Other||Ratio|1.121|Standard Error of the Mean|0.036||0.0003|2-Sided|95.0|1.054|1.193|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Placebo QD||
1661088|NCT01533935|3056204|Superiority or Other||Ratio|1.043|Standard Error of the Mean|0.033||0.1807|2-Sided|95.0|0.981|1.109|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Tiotropium 5 mcg QD||
1661089|NCT01533935|3056204|Superiority or Other||Ratio|1.111|Standard Error of the Mean|0.035||0.0009|2-Sided|95.0|1.045|1.182|||Mixed Models Analysis||Ratio calculated Tiotropium + olodaterol 5/5 QD as divided by Olodaterol 5 mcg QD||
1661090|NCT01533935|3056204|Superiority or Other||Ratio|1.134|Standard Error of the Mean|0.036|<|0.0001|2-Sided|95.0|1.065|1.206|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Placebo QD||
1661091|NCT01533935|3056205|Superiority or Other||Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.025||0.0001|2-Sided|95.0|0.047|0.147|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD||
1661092|NCT01533935|3056205|Superiority or Other||Mean Difference (Final Values)|0.089|Standard Error of the Mean|0.025||0.0004|2-Sided|95.0|0.039|0.138|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD||
1661093|NCT01533935|3056205|Superiority or Other||Mean Difference (Final Values)|0.274|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.224|0.324|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD||
1661094|NCT01533935|3056205|Superiority or Other||Mean Difference (Final Values)|0.088|Standard Error of the Mean|0.025|<|0.0005|2-Sided|95.0|0.039|0.137|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD||
1661095|NCT01533935|3056205|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.025|<|0.0015|2-Sided|95.0|0.031|0.129|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD||
1661096|NCT01533935|3056205|Superiority or Other||Mean Difference (Final Values)|0.265|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.215|0.315|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD||
1661097|NCT01533922|3056206|Superiority or Other||Mean Difference (Final Values)|0.077|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.047|0.106|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD||
1661098|NCT01533922|3056206|Superiority or Other||Mean Difference (Final Values)|0.093|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.063|0.123|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD||
1661099|NCT01533922|3056206|Superiority or Other||Mean Difference (Final Values)|0.286|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.256|0.315|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD||
1661100|NCT01533922|3056206|Superiority or Other||Mean Difference (Final Values)|0.114|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.084|0.143|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD||
1661101|NCT01533922|3056206|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.101|0.16|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD||
1661102|NCT01533922|3056206|Superiority or Other||Mean Difference (Final Values)|0.323|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.293|0.352|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD||
1661103|NCT01533922|3056207|Superiority or Other||Mean Difference (Final Values)|-0.001|Standard Error of the Mean|0.001||0.4567|2-Sided|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD||
1661104|NCT01533922|3056207|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.001||0.7294|2-Sided|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD||
1661105|NCT01533922|3056207|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.001|<|0.0001|2-Sided|95.0|-0.005|-0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD||
1661106|NCT01533922|3056207|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.001|<|0.857|2-Sided|95.0|-0.002|0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD||
1661107|NCT01533922|3056207|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.001|<|0.8291|2-Sided|95.0|-0.001|0.002|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg QD||
1661108|NCT01533922|3056207|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.001|<|0.0004|2-Sided|95.0|-0.004|-0.001|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Placebo QD||
1661109|NCT01533922|3056208|Superiority or Other||Ratio|1.039|Standard Error of the Mean|0.035||0.261|2-Sided|95.0|0.972|1.11|||Mixed Models Analysis||Ratio calculated asTiotropium + olodaterol 2.5/5 QD divided by Tiotropium 5 mcg QD||
1661110|NCT01533922|3056208|Superiority or Other||Ratio|1.047|Standard Error of the Mean|0.035||0.1717|2-Sided|95.0|0.98|1.119|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Olodaterol 5 mcg QD||
1661111|NCT01533922|3056208|Superiority or Other||Ratio|1.265|Standard Error of the Mean|0.042|<|0.0001|2-Sided|95.0|1.184|1.351|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 2.5/5 QD divided by Placebo QD||
1661112|NCT01533922|3056208|Superiority or Other||Ratio|0.993|Standard Error of the Mean|0.033|<|0.8415|2-Sided|95.0|0.93|1.061|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Tiotropium 5 mcg QD||
1661113|NCT01533922|3056208|Superiority or Other||Ratio|1.002|Standard Error of the Mean|0.034|<|0.9633|2-Sided|95.0|0.937|1.07|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Olodaterol 5 mcg QD||
1661114|NCT01533922|3056208|Superiority or Other||Ratio|1.209|Standard Error of the Mean|0.041|<|0.0001|2-Sided|95.0|1.132|1.292|||Mixed Models Analysis||Ratio calculated as Tiotropium + olodaterol 5/5 QD divided by Placebo QD||
1661115|NCT01533922|3056209|Superiority or Other||Mean Difference (Final Values)|0.087|Standard Error of the Mean|0.027||0.0015|2-Sided|95.0|0.034|0.141|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Tiotropium 5 mcg QD||
1661116|NCT01533922|3056209|Superiority or Other||Mean Difference (Final Values)|0.092|Standard Error of the Mean|0.027||0.0008|2-Sided|95.0|0.038|0.145|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Olodaterol 5 mcg QD||
1661117|NCT01533922|3056209|Superiority or Other||Mean Difference (Final Values)|0.218|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.164|0.271|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 2.5/5 QD minus Placebo QD||
1661118|NCT01533922|3056209|Superiority or Other||Mean Difference (Final Values)|0.114|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.061|0.167|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Tiotropium 5 mcg QD||
1661119|NCT01533922|3056209|Superiority or Other||Mean Difference (Final Values)|0.119|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.065|0.172|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 QD minus Olodaterol 5 mcg||
1661120|NCT01533922|3056209|Superiority or Other||Mean Difference (Final Values)|0.244|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.191|0.298|||Mixed Models Analysis||Difference calculated as Tiotropium + olodaterol 5/5 once daily (QD) minus Placebo||
1661121|NCT01533428|3056227|Superiority or Other||LS Mean Difference|-9.5||||0.02|2-Sided|95.0|-17.4|-1.5|||ANCOVA|Analysis of covariance model including treatment,gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.|
1661122|NCT01533428|3056227|Superiority or Other||LS Mean Difference|-9.0||||0.03|2-Sided|95.0|-17.2|-0.9|||ANCOVA|Analysis of covariance model including treatment,gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.|
1661123|NCT01533428|3056229|Superiority or Other||LS Mean Difference|-0.1||||0.595|2-Sided|95.0|-0.7|0.4|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 12 was completed using ANCOVA model.|
1661124|NCT01533428|3056229|Superiority or Other||LS Mean Difference|-0.4||||0.171|2-Sided|95.0|-0.9|0.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 8 was completed using ANCOVA model.|
1661125|NCT01533428|3056229|Superiority or Other||LS Mean Difference|-0.1||||0.841|2-Sided|95.0|-0.6|0.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 2 was completed using ANCOVA model.|
1661126|NCT01533428|3056230|Superiority or Other||LS Mean Difference|-0.1||||0.726|2-Sided|95.0|-0.7|0.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 12 was completed using ANCOVA model.|
1661127|NCT01533428|3056230|Superiority or Other||LS Mean Difference|-0.3||||0.334|2-Sided|95.0|-0.8|0.3|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 8 was completed using ANCOVA model.|
1661128|NCT01533428|3056230|Superiority or Other||LS Mean Difference|0.1||||0.719|2-Sided|95.0|-0.5|0.7|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for change from Baseline at Week 2 was completed using ANCOVA model.|
1661236|NCT01529749|3056513|Superiority|||||||1|||||||Chi-squared, Corrected||||
1661129|NCT01533428|3056231|Superiority or Other||LS Mean Difference|1.7||||0.514|2-Sided|95.0|-4.4|2.2|||ANCOVA|||The statistical comparison between Baseline and Week 2 was made using two-sided tests at the 5% significance level.|
1661130|NCT01533428|3056231|Superiority or Other||LS Mean Difference|1.2||||0.473|2-Sided|95.0|-2.1|4.5|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||The statistical comparison between Baseline and Week 12 was made using two-sided tests at the 5% significance level.|
1661131|NCT01533428|3056231|Superiority or Other||LS Mean Difference|1.7||||0.32|2-Sided|95.0|-1.6|5.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||The statistical comparison between Baseline and Week 8 was made using two-sided tests at the 5% significance level.|
1661132|NCT01533428|3056232|Superiority or Other|||||||0.169|||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.|
1661133|NCT01533428|3056233|Superiority or Other|||||||0.075|||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.|
1661134|NCT01533428|3056234|Superiority or Other|||||||0.072|||||||Cochran-Mantel-Haenszel|Analysis of Cochran-Mantel-Haenszel test model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparing the difference between capsaicin 8% and placebo for counts by category using a Cochran-Mantel-Haenszel test.|
1661135|NCT01533428|3056235|Superiority or Other||Odds Ratio (OR)|1.2||||0.446|2-Sided|95.0|0.7|2.0|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.|
1661136|NCT01533428|3056235|Superiority or Other||Odds Ratio (OR)|1.2||||0.403|2-Sided|95.0|0.7|2.1|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 50% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.|
1661137|NCT01533428|3056236|Superiority or Other||Odds Ratio (OR)|1.5||||0.05|2-Sided|95.0|1.0|2.4|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-12. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.|
1661138|NCT01533428|3056236|Superiority or Other||Odds Ratio (OR)|1.4||||0.108|2-Sided|95.0|0.9|2.2|||Regression, Logistic|Analysis of regression logistics model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Percentage of participants with 30% reduction in average daily pain score assessed in Weeks 2-8. The comparison of the odds ratio of capsaicin 8% to placebo for percent change from baseline was performed using a logistic regression model.|
1661139|NCT01533428|3056238|Superiority or Other||LS Mean Difference|-9.0||||0.005|2-Sided|95.0|-15.3|-2.7|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 12.|
1661140|NCT01533428|3056238|Superiority or Other||LS Mean Difference|-7.4||||0.022|2-Sided|95.0|-13.7|-1.1|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 11.|
1661141|NCT01533428|3056238|Superiority or Other||LS Mean Difference|-7.5||||0.02|2-Sided|95.0|-13.9|-1.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 10.|
1661142|NCT01533428|3056238|Superiority or Other||LS Mean Difference|-6.9||||0.032|2-Sided|95.0|-13.2|-0.6|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 9.|
1661143|NCT01533428|3056238|Superiority or Other||LS Mean Difference|-7.2||||0.026|2-Sided|95.0|-13.5|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 8.|
1661144|NCT01533428|3056238|Superiority or Other||LS Mean Difference|-8.1||||0.012|2-Sided|95.0|-14.4|-1.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 7.|
1661145|NCT01533428|3056238|Superiority or Other||LS Mean Difference|-6.3||||0.051|2-Sided|95.0|-12.6|0.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 6.|
1661146|NCT01533428|3056238|Superiority or Other||LS Mean Difference|-7.3||||0.024|2-Sided|95.0|-13.6|-1.0|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 5.|
1661147|NCT01533428|3056238|Superiority or Other||LS Mean Difference|-7.2||||0.027|2-Sided|95.0|-13.5|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 4.|
1661237|NCT01529749|3056514|Superiority|||||||1|||||||Chi-squared, Corrected||||
1661238|NCT01529749|3056515|Superiority|||||||1|||||||Chi-squared, Corrected||||
1661148|NCT01533428|3056238|Superiority or Other||LS Mean Difference|-6.7||||0.036|2-Sided|95.0|-13.1|-0.4|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 3.|
1661149|NCT01533428|3056238|Superiority or Other||LS Mean Difference|-4.1||||0.208|2-Sided|95.0|-10.4|2.3|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||Comparison of capsaicin 8% and placebo for change from Baseline to Week 2.|
1661150|NCT01533428|3056239|Superiority or Other||LS Mean Difference|-7.1||||0.018|2-Sided|95.0|-12.9|-1.2|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level.|
1661151|NCT01533428|3056240|Superiority or Other||LS Mean Difference|-6.6||||0.025|2-Sided|95.0|-12.3|-0.8|||ANCOVA|Analysis of covariance model including treatment, gender, pain score at baseline, HbA1c at screening and site as factors/covariates.||All statistical comparisons were made using two-sided tests at the 5% significance level|
1661152|NCT01533181|3056255|Superiority or Other||Hazard Ratio (HR)|1.1||||0.71|2-Sided|95.0|0.6|2.2|||Kaplan-Meier||||
1661153|NCT01533181|3056258|Superiority or Other||Hazard Ratio (HR)|3.9||||0.0001|2-Sided|95.0|1.9|8.1|||Kaplan-Meier||||
1661154|NCT01532999|3056281|Superiority or Other|||||||0.7|||||||Regression, Logistic|||Mixed effects logistic regression analysis.|
1661155|NCT01532999|3056282|Superiority or Other|||||||0.3|||||||Regression, Logistic|||Mixed effects logistic regression analysis.|
1661156|NCT01532999|3056283|Superiority or Other|||||||0.35|||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.|
1661157|NCT01532999|3056284|Superiority or Other|||||||0.4|||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.|
1661158|NCT01532999|3056285|Superiority or Other|||||||0.8|||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.|
1661159|NCT01532999|3056286|Superiority or Other|||||||0.4|||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.|
1661160|NCT01532999|3056288|Superiority or Other|||||||0.57|||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks.|
1661161|NCT01532999|3056289|Superiority or Other|||||||0.5|||||||Regression, Linear|||Three-level mixed-effects linear regression analysis comparing MBSR and PCGT groups over 9 weeks. Data structure involved repeated measures over time nested within participant, who in turn, was nested within a therapy group. Models included a random intercept, a random slope, and fixed effects for treatment condition, time, and the stratification variable (site). Rejection of the null hypothesis of no treatment effect if this interaction was statistically significant (two-tailed α = .05).|
1661162|NCT01532986|3056290|Superiority||Mean Difference (Final Values)|-1.98|||>|0.05|2-Sided|95.0|-4.2|0.24|||t-test, 2 sided||||
1661163|NCT01532986|3056291|Superiority||Mean Difference (Final Values)|-11.52|||<|0.05|2-Sided|95.0|-20.42|-2.62|||t-test, 2 sided||||
1661164|NCT01532986|3056292|Superiority||Mean Difference (Final Values)|-0.06|||>|0.05|2-Sided|95.0|-1.45|1.33|||t-test, 2 sided||||
1661165|NCT01532986|3056293|Superiority||Mean Difference (Final Values)|0.17|||>|0.05|2-Sided|95.0|0.0|0.34|||t-test, 2 sided||||
1661166|NCT01532986|3056294|Superiority||Mean Difference (Final Values)|1.22|||>|0.05|2-Sided|95.0|-8.02|10.46|||t-test, 2 sided||||
1661167|NCT01532986|3056295|Superiority||Mean Difference (Final Values)|-0.88|||>|0.05|2-Sided|95.0|-2.04|0.29|||t-test, 2 sided||||
1661168|NCT01532986|3056296|Superiority||Mean Difference (Final Values)|-0.12|||>|0.05|2-Sided|95.0|-0.34|0.1|||t-test, 2 sided||||
1661169|NCT01532986|3056297|Superiority||Mean Difference (Final Values)|0.02|||>|0.05|2-Sided|95.0|-0.52|0.57|||t-test, 2 sided||||
1661170|NCT01532986|3056298|Superiority||Mean Difference (Final Values)|0.02|||>|0.05|2-Sided|95.0|-0.04|0.08|||t-test, 2 sided||||
1661171|NCT01532986|3056299|Superiority||Mean Difference (Final Values)|0.189|||>|0.05|2-Sided|95.0|0.157|0.222|||t-test, 2 sided||||
1661172|NCT01532973|3056302|Superiority or Other||Difference in LS Means|3.63|||||2-Sided|90.0|3.0|4.26|||||||
1661173|NCT01532973|3056302|Superiority or Other||Difference in LS Means|3.17|||||2-Sided|90.0|2.55|3.8|||||||
1661174|NCT01532973|3056303|Superiority or Other||Difference in LS Means|2.84|||||2-Sided|90.0|2.02|3.66|||||||
1661175|NCT01532973|3056303|Superiority or Other||Difference in LS Means|2.57|||||2-Sided|90.0|1.75|3.39|||||||
1661176|NCT01532973|3056303|Superiority or Other||Difference in LS Means|0.72|||||2-Sided|90.0|-0.09|1.54|||||||
1661177|NCT01532973|3056304|Superiority or Other||Difference in LS Means|3.61|||||2-Sided|90.0|2.92|4.3|||||||
1661178|NCT01532973|3056304|Superiority or Other||Difference in LS Means|4.67|||||2-Sided|90.0|3.98|5.36|||||||
1661179|NCT01532973|3056304|Superiority or Other||Difference in LS Means|3.89|||||2-Sided|90.0|3.2|4.58|||||||
1661180|NCT01532973|3056305|Superiority or Other||Difference in LS Means|3.95|||||2-Sided|90.0|3.44|4.47|||||||
1661181|NCT01532973|3056305|Superiority or Other||Difference in LS Means|3.2|||||2-Sided|90.0|2.68|3.72|||||||
1661182|NCT01532973|3056306|Superiority or Other||Difference in LS Means|2.72|||||2-Sided|90.0|2.05|3.39|||||||
1661183|NCT01532973|3056306|Superiority or Other||Difference in LS Means|2.07|||||2-Sided|90.0|1.39|2.74|||||||
1661184|NCT01532973|3056306|Superiority or Other||Difference in LS Means|1.02|||||2-Sided|90.0|0.34|1.69|||||||
1661185|NCT01532973|3056307|Superiority or Other||Difference in LS Means|3.56|||||2-Sided|90.0|3.08|4.05|||||||
1661186|NCT01532973|3056307|Superiority or Other||Difference in LS Means|4.41|||||2-Sided|90.0|3.92|4.9|||||||
1661187|NCT01532973|3056307|Superiority or Other||Difference in LS Means|4.26|||||2-Sided|90.0|3.77|4.74|||||||
1661239|NCT01529749|3056516|Superiority|||||||1|||||||Chi-squared, Corrected||||
1661240|NCT01529749|3056517|Superiority|||||||0.01|||||||Kruskal-Wallis||||
1661188|NCT01532934|3056308|Superiority or Other|||||||0.69||||||a priori threshold p<.05|Regression, Logistic|||Experimental hypothesis: Treatment X F1 interaction will predict fewer charges at one-year follow-up for individuals low on F1 who got treatment relative to individuals low on F1 who did not.|
1661189|NCT01532934|3056309|Superiority or Other|||||||0.34||||||As stated, the p-value reflects the F1 X treatment interaction term and its effect on substance use consequences. A priori threshold for significance was p<.05.|Regression, Linear|||Experimental hypothesis: The F1 X treatment interaction will show that individuals low on F1 who get treatment will reduce substance use consequences at six months relative to those low on F1 who get standard care.|
1661190|NCT01532934|3056310|Superiority or Other|||||||0.02||||||As stated, the p-value reflects the Factor 1 by treatment interaction term and its effect on percent days abstinent/month.|Regression, Linear|||A priori hypothesis. Psychopathy Factor 1 (F1) X treatment interaction to predict higher substance use among people high in F1 + who get treatment relative to individuals with high F1 who get standard care.|
1661191|NCT01532869|3056324|Superiority or Other||Odds Ratio (OR)|2.39|Standard Error of the Mean|0.704||0.2159|2-Sided|95.0|0.6|9.5|||Regression, Logistic|||The logistic regression model included the fixed categorical effects of treatment and the stratification factor of joint involvement at the baseline visit. The continuous covariate of baseline mRSS score was also included in the model.|
1661192|NCT01532869|3056325|Superiority or Other||Difference in LS mean|-3.55||||0.0579|2-Sided|95.0|-7.23|0.12|||Mixed Models Analysis|||The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661193|NCT01532869|3056326|Superiority or Other||Difference in LS mean|-1.11||||0.2841|2-Sided|95.0|-3.16|0.94|||Mixed Models Analysis|||Change From Baseline in 5-D Itch Scale at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661194|NCT01532869|3056326|Superiority or Other||Difference in LS mean|0.79||||0.3651|2-Sided|95.0|-0.94|2.51|||Mixed Models Analysis|||Change From Baseline in 5-D Itch Scale at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661195|NCT01532869|3056327|Superiority or Other||Difference in LS mean|2.75||||0.1886|2-Sided|95.0|-1.38|6.88|||Mixed Models Analysis|||Change From Baseline in FACIT-Fatigue Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661196|NCT01532869|3056327|Superiority or Other||Difference in LS mean|1.43||||0.5197|2-Sided|95.0|-2.97|5.82|||Mixed Models Analysis|||Change From Baseline in FACIT-Fatigue Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661197|NCT01532869|3056328|Superiority or Other||Difference in LS mean|-8.3||||0.1371|2-Sided|95.0|-19.31|2.71|||Mixed Models Analysis|||Change From Baseline in Patient's Global Assessment at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661198|NCT01532869|3056328|Superiority or Other||Difference in LS mean|-3.85||||0.4063|2-Sided|95.0|-13.04|5.34|||Mixed Models Analysis|||Change From Baseline in Patient’s Global Assessment at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661199|NCT01532869|3056329|Superiority or Other||Difference in LS mean|-9.02||||0.0768|2-Sided|95.0|-19.04|1.0|||Mixed Models Analysis|||Change From Baseline in Clinician's Global Assessment at Week 48.The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661200|NCT01532869|3056329|Superiority or Other||Difference in LS mean|-0.99||||0.8118|2-Sided|95.0|-9.2|7.23|||Mixed Models Analysis|||Change From Baseline in Clinician’s Global Assessment at Week 24.The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661201|NCT01532869|3056330|Superiority or Other||Difference in LS mean|-0.207||||0.1212|2-Sided|95.0|-0.471|0.056|||Mixed Models Analysis|||Change From Baseline in HAQ-DI Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661202|NCT01532869|3056330|Superiority or Other||Difference in LS mean|0.02||||0.8503|2-Sided|95.0|-0.186|0.225|||Mixed Models Analysis|||Change From Baseline in HAQ-DI Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction|
1661203|NCT01532869|3056331|Superiority or Other||Difference in LS mean|-7.82||||0.1717|2-Sided|95.0|-19.11|3.48|||Mixed Models Analysis|||Change From Baseline in Overall Disease Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661241|NCT01529749|3056518|Superiority|||||||1|||||||Chi-squared, Corrected||||
1661242|NCT01529749|3056519|Superiority|||||||1|||||||Chi-squared, Corrected||||
1661243|NCT01529749|3056520|Superiority|||||||1|||||||Chi-squared, Corrected||||
1661204|NCT01532869|3056331|Superiority or Other||Difference in LS mean|-5.8||||0.3106|2-Sided|95.0|-17.2|5.59|||Mixed Models Analysis|||Change From Baseline in Finger Ulcers Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661205|NCT01532869|3056331|Superiority or Other||Difference in LS mean|-4.48||||0.5182|2-Sided|95.0|-18.28|9.31|||Mixed Models Analysis|||Change From Baseline in Raynaud Syndrome Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661206|NCT01532869|3056331|Superiority or Other||Difference in LS mean|1.54||||0.7742|2-Sided|95.0|-9.18|12.26|||Mixed Models Analysis|||Change From Baseline in Breathing VAS Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661207|NCT01532869|3056331|Superiority or Other||Difference in LS mean|-6.8||||0.2407|2-Sided|95.0|-18.3|4.71|||Mixed Models Analysis|||Change From Baseline in Intestinal VAS Score at Week 48. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661208|NCT01532869|3056331|Superiority or Other||Difference in LS mean|-0.08||||0.9876|2-Sided|95.0|-9.93|9.78|||Mixed Models Analysis|||Change From Baseline in Overall Disease Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661209|NCT01532869|3056331|Superiority or Other||Difference in LS mean|4.89||||0.4717|2-Sided|95.0|-8.59|18.37|||Mixed Models Analysis|||Change From Baseline in Finger Ulcers Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661210|NCT01532869|3056331|Superiority or Other||Difference in LS mean|-1.28||||0.8493|2-Sided|95.0|-14.7|12.13|||Mixed Models Analysis|||Change From Baseline in Raynaud Syndrome Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661211|NCT01532869|3056331|Superiority or Other||Difference in LS mean|-4.12||||0.4609|2-Sided|95.0|-15.21|6.96|||Mixed Models Analysis|||Change From Baseline in Breathing VAS Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661212|NCT01532869|3056331|Superiority or Other||Difference in LS mean|-0.43||||0.9336|2-Sided|95.0|-10.78|9.91|||Mixed Models Analysis|||Change From Baseline in Intestinal VAS Score at Week 24. The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661213|NCT01532869|3056333|Superiority or Other||Difference in Least Square (LS) mean|-2.7||||0.0915|2-Sided|95.0|-5.85|0.45|||Mixed Models Analysis|||The analysis included the fixed, categorical effects of treatment, visit, the stratification factor of joint involvement at the baseline visit, and treatment-by-visit interaction, as well as the continuous covariates of baseline score and baseline score-by-visit interaction.|
1661214|NCT01532453|3056376|Superiority or Other||Odds Ratio (OR)|0.579|||<|0.05|2-Sided|95.0|0.2703|1.2405|||ANCOVA||||
1661215|NCT01532453|3056377|Superiority or Other|||||||0.0278||||||Rank ANCOVA With treatment, center, gender, transplanted organ as factors and age of organ transplant as a covariable.|ANCOVA||||
1661216|NCT01532089|3056396|Superiority|||||||0.81|||||||Chi-squared||||
1661217|NCT01532089|3056397|Superiority||Hazard Ratio (HR)|1.41||||0.33|2-Sided|95.0|0.71|2.81|||Log Rank||||
1661218|NCT01532089|3056398|Superiority||Hazard Ratio (HR)|0.81||||0.39|2-Sided|95.0|0.5|1.31|||Log Rank|Comparisons of PFS between arms were conducted using a stratified log-rank test.|||
1661219|NCT01531673|3056418|Superiority||LS Mean Difference|-17.2||||0.0238|2-Sided|95.0|-31.75|-2.65|||MMRM||||
1661220|NCT01531673|3056419|Superiority||LS Mean Difference|-6.7||||0.0357|2-Sided|95.0|-12.94|-0.46|||MMRM||||
1661221|NCT01531673|3056420|Superiority||LS Mean Difference|-1.77||||0.3745|2-Sided|95.0|-5.71|2.17|||MMRM||||
1661222|NCT01531673|3056420|Superiority||LS Mean Difference|-9.6||||0.0001|2-Sided|95.0|-14.38|-4.82|||MMRM||||
1661223|NCT01531673|3056420|Superiority||LS Mean Difference|-5.19||||0.011|2-Sided|95.0|-9.16|-1.21|||MMRM||||
1661224|NCT01531673|3056420|Superiority||LS Mean Difference|-5.14||||0.0101|2-Sided|95.0|-9.03|-1.25|||MMRM||||
1661225|NCT01531673|3056420|Superiority||LS Mean Difference|-19.58|||<|0.0001|2-Sided|95.0|-24.57|-14.59|||MMRM||||
1661226|NCT01531673|3056420|Superiority||LS Mean Difference|-4.2|||<|0.0348|2-Sided|95.0|-8.1|-0.31|||MMRM||||
1661227|NCT01531673|3056420|Superiority||LS Mean Difference|-3.91|||<|0.1686|2-Sided|95.0|-9.5|1.68|||MMRM||||
1661228|NCT01531673|3056420|Superiority||Least Squares (LS) Mean Difference|4.77|||<|0.0647|2-Sided|95.0|-0.3|9.84|||Mixed-effect repeated measure (MMRM)||||
1661229|NCT01530178|3056502|Other||Mean Difference (Final Values)|-25.78||||0.0005|2-Sided|95.0|-38.39|-13.17|||ANOVA||||
1661230|NCT01530178|3056502|Other|Non-specified|Mean Difference (Final Values)|-2.131||||0.68|2-Sided|95.0|-12.91|8.652|||ANOVA||||
1661231|NCT01530178|3056502|Other|Non-specified|Mean Difference (Final Values)|-27.91||||0.003|2-Sided|95.0|-44.7|-11.2|||ANOVA||||
1661232|NCT01529749|3056509|Superiority|||||||0.02|||||||Kruskal-Wallis||||
1661245|NCT01529749|3056522|Superiority|||||||1|||||||Chi-squared, Corrected||||
1661246|NCT01529749|3056523|Superiority|||||||1|||||||Chi-squared, Corrected||||
1661247|NCT01529749|3056524|Superiority|||||||1|||||||Chi-squared, Corrected||||
1661248|NCT01529749|3056525|Superiority|||||||1|||||||Chi-squared, Corrected||||
1661249|NCT01529385|3056563|Superiority or Other||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA||||
1661250|NCT01529385|3056564|Superiority or Other||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA||||
1661251|NCT01529385|3056565|Superiority or Other||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA||||
1661252|NCT01529385|3056567|Superiority or Other||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA||||
1661253|NCT01529385|3056568|Superiority or Other||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA||||
1661254|NCT01529385|3056569|Superiority or Other||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA||||
1661255|NCT01529385|3056570|Superiority or Other||||||<|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA||||
1661256|NCT01529385|3056571|Superiority or Other||||||<|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA||||
1661257|NCT01529385|3056572|Superiority or Other||||||>|0.05||||||0.05 set as a priori threshold for statistical significance; Sidak correction for multiple comparisons used|ANOVA||||
1661258|NCT01529346|3056581|Superiority or Other||Hazard Ratio (HR)|0.4|||||2-Sided|90.0|0.2|0.6||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1661259|NCT01529346|3056581|Superiority or Other||Hazard Ratio (HR)|0.5|||||2-Sided|90.0|0.3|0.8||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1661260|NCT01529346|3056581|Superiority or Other||Hazard Ratio (HR)|0.8|||||2-Sided|90.0|0.5|1.2||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1661261|NCT01529346|3056581|Superiority or Other||Hazard Ratio (HR)|0.6|||||2-Sided|90.0|0.4|1.0||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1661262|NCT01529346|3056582|Superiority or Other||Hazard Ratio (HR)|5.3|||||2-Sided|90.0|2.8|9.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1661263|NCT01529346|3056582|Superiority or Other||Hazard Ratio (HR)|2.2|||||2-Sided|90.0|1.1|4.1||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1661264|NCT01529346|3056582|Superiority or Other||Hazard Ratio (HR)|2.6|||||2-Sided|90.0|1.4|4.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1661265|NCT01529346|3056582|Superiority or Other||Hazard Ratio (HR)|2.0|||||2-Sided|90.0|1.1|3.8||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1661266|NCT01529346|3056583|Superiority or Other||Hazard Ratio (HR)|1.6|||||2-Sided|90.0|1.0|2.4||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1661267|NCT01529346|3056583|Superiority or Other||Hazard Ratio (HR)|1.1|||||2-Sided|90.0|0.7|1.6||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1661268|NCT01529346|3056583|Superiority or Other||Hazard Ratio (HR)|1.3|||||2-Sided|90.0|0.9|1.9||||||HR estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1661269|NCT01529346|3056583|Superiority or Other||Hazard Ratio (HR)|1.0|||||2-Sided|90.0|0.6|1.5||||||Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based on Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1661270|NCT01529346|3056584|Superiority or Other||LS Mean Difference|32.56|Standard Error of the Mean|7.3|||2-Sided|90.0|20.51|44.61|||||||
1661271|NCT01529346|3056584|Superiority or Other||LS Mean Difference|12.57|Standard Error of the Mean|6.69|||2-Sided|90.0|1.52|23.61|||||||
1661272|NCT01529346|3056584|Superiority or Other||LS Mean Difference|4.18|Standard Error of the Mean|6.66|||2-Sided|90.0|-6.82|15.18||||||LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.|
1661273|NCT01529346|3056584|Superiority or Other||LS Mean Difference|12.26|Standard Error of the Mean|6.66|||2-Sided|90.0|1.26|23.27||||||LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.|
1661274|NCT01529346|3056585|Superiority or Other||LS Mean Difference|22.39|Standard Error of the Mean|5.19|||2-Sided|90.0|13.82|30.97||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.|
1661275|NCT01529346|3056585|Superiority or Other||LS Mean Difference|10.82|Standard Error of the Mean|4.76|||2-Sided|90.0|2.97|18.68||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.|
1661413|NCT01528254|3056740|Other||Slope|-5.38|Standard Error of the Mean|1.64||0.001|2-Sided|95.0|-8.61|-2.16|||Mixed Models Analysis|||From Week 13 to end of study|
1661276|NCT01529346|3056585|Superiority or Other||LS Mean Difference|3.55|Standard Error of the Mean|4.74|||2-Sided|90.0|-4.28|11.37||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.|
1661277|NCT01529346|3056585|Superiority or Other||LS Mean Difference|9.8|Standard Error of the Mean|4.74|||2-Sided|90.0|1.97|17.63||||||SPID(24): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.|
1661278|NCT01529346|3056585|Superiority or Other||LS Mean Difference|6.99|Standard Error of the Mean|1.09|||2-Sided|90.0|5.19|8.79||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.|
1661279|NCT01529346|3056585|Superiority or Other||LS Mean Difference|2.34|Standard Error of the Mean|1.0|||2-Sided|90.0|0.69|3.99||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.|
1661280|NCT01529346|3056585|Superiority or Other||LS Mean Difference|1.69|Standard Error of the Mean|0.99|||2-Sided|90.0|0.05|3.33||||||SPID(6): LS mean estimate of the treatment difference along with 90% CI were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.|
1661281|NCT01529346|3056585|Superiority or Other||LS Mean Difference|2.07|Standard Error of the Mean|0.99|||2-Sided|90.0|0.43|3.71||||||SPID(6): LS mean estimate of the treatment difference along with 90% confidence interval (CI) were based on an ANCOVA model included treatment as a fixed effect and baseline pain intensity as a covariate.|
1661282|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.06|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.32|0.45||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661283|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.31|Standard Error of the Mean|0.22|||2-Sided|90.0|-0.07|0.68||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661284|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.04|Standard Error of the Mean|0.24|||2-Sided|90.0|-0.36|0.44||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661285|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.45|Standard Error of the Mean|0.23|||2-Sided|90.0|0.07|0.83||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661286|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.64|Standard Error of the Mean|0.33|||2-Sided|90.0|0.08|1.19||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661287|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.25|Standard Error of the Mean|0.34|||2-Sided|90.0|-0.31|0.8||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661288|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.34|Standard Error of the Mean|0.36|||2-Sided|90.0|-0.25|0.94||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661289|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.32|Standard Error of the Mean|0.34|||2-Sided|90.0|-0.24|0.89||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661290|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.82|Standard Error of the Mean|0.3|||2-Sided|90.0|0.33|1.31||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661291|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.27|Standard Error of the Mean|0.3|||2-Sided|90.0|-0.23|0.77||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661292|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.14|Standard Error of the Mean|0.31|||2-Sided|90.0|-0.37|0.65||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661293|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.23|Standard Error of the Mean|0.3|||2-Sided|90.0|-0.27|0.72||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661644|NCT01524796|3057162|Superiority or Other||||||<|0.001|||||||paired Wilcoxon signed-rank test||||
1661294|NCT01529346|3056586|Superiority or Other||LS Mean Difference|1.17|Standard Error of the Mean|0.25|||2-Sided|90.0|0.75|1.59||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661295|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.51|Standard Error of the Mean|0.25|||2-Sided|90.0|0.09|0.93||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661296|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.41|Standard Error of the Mean|0.26|||2-Sided|90.0|-0.03|0.84||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661297|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.5|Standard Error of the Mean|0.25|||2-Sided|90.0|0.08|0.92||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661298|NCT01529346|3056586|Superiority or Other||LS Mean Difference|1.38|Standard Error of the Mean|0.24|||2-Sided|90.0|0.97|1.78||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661299|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.63|Standard Error of the Mean|0.24|||2-Sided|90.0|0.24|1.03||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661300|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.57|Standard Error of the Mean|0.24|||2-Sided|90.0|0.17|0.97||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661301|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.55|Standard Error of the Mean|0.24|||2-Sided|90.0|0.16|0.95||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661302|NCT01529346|3056586|Superiority or Other||LS Mean Difference|1.3|Standard Error of the Mean|0.23|||2-Sided|90.0|0.92|1.68||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661303|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.41|Standard Error of the Mean|0.22|||2-Sided|90.0|0.05|0.77||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661304|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.33|Standard Error of the Mean|0.22|||2-Sided|90.0|-0.03|0.69||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661305|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.4|Standard Error of the Mean|0.22|||2-Sided|90.0|0.04|0.76||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661306|NCT01529346|3056586|Superiority or Other||LS Mean Difference|1.26|Standard Error of the Mean|0.21|||2-Sided|90.0|0.92|1.61||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661307|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.39|Standard Error of the Mean|0.19|||2-Sided|90.0|0.08|0.71||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661308|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.31|Standard Error of the Mean|0.19|||2-Sided|90.0|-0.01|0.62||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661309|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.33|Standard Error of the Mean|0.19|||2-Sided|90.0|0.01|0.64||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661407|NCT01528891|3056646|Superiority or Other||||||<|0.01||||||"P<0.01 for the following time points, as compared to the baseline value: 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|ANOVA|||Heart rate values were compared over time against the baseline value.|
1661310|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.74|Standard Error of the Mean|0.2|||2-Sided|90.0|0.41|1.06||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661311|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.13|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.16|0.43||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661312|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.19|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.1|0.49||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661313|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.19|0.4||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661314|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.71|Standard Error of the Mean|0.18|||2-Sided|90.0|0.4|1.01||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661315|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.23|Standard Error of the Mean|0.17|||2-Sided|90.0|-0.05|0.5||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661316|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.4|Standard Error of the Mean|0.17|||2-Sided|90.0|0.12|0.68||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661317|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.12|Standard Error of the Mean|0.17|||2-Sided|90.0|-0.16|0.4||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661318|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.59|Standard Error of the Mean|0.17|||2-Sided|90.0|0.32|0.87||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661319|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.29|Standard Error of the Mean|0.15|||2-Sided|90.0|0.04|0.54||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661320|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.44|Standard Error of the Mean|0.15|||2-Sided|90.0|0.19|0.7||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661321|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|0.15|||2-Sided|90.0|-0.06|0.45||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661322|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.02|Standard Error of the Mean|0.11|||2-Sided|90.0|-0.16|0.21||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661323|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.07|Standard Error of the Mean|0.1|||2-Sided|90.0|-0.1|0.24||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661324|NCT01529346|3056586|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|0.1|||2-Sided|90.0|0.03|0.37||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661325|NCT01529346|3056586|Superiority or Other||LS Mean Difference|-0.02|Standard Error of the Mean|0.1|||2-Sided|90.0|-0.19|0.14||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661408|NCT01528891|3056646|Superiority or Other||||||<|0.01||||||"P<0.01 for the following time points, as compared to the baseline value: 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|ANOVA|||Heart rate values were compared over time against the baseline value.|
1661326|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.19|Standard Error of the Mean|0.29|||2-Sided|90.0|-0.3|0.67||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661327|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.44|Standard Error of the Mean|0.28|||2-Sided|90.0|-0.03|0.91||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661328|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.24|Standard Error of the Mean|0.3|||2-Sided|90.0|-0.27|0.74||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661329|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.63|Standard Error of the Mean|0.29|||2-Sided|90.0|0.15|1.11||||||24 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661330|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.27|Standard Error of the Mean|0.45|||2-Sided|90.0|-0.47|1.02||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661331|NCT01529346|3056587|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.45|||2-Sided|90.0|-1.05|0.45||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661332|NCT01529346|3056587|Superiority or Other||LS Mean Difference|-0.18|Standard Error of the Mean|0.48|||2-Sided|90.0|-0.98|0.62||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661333|NCT01529346|3056587|Superiority or Other||LS Mean Difference|-0.17|Standard Error of the Mean|0.46|||2-Sided|90.0|-0.93|0.59||||||8 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661334|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.9|Standard Error of the Mean|0.41|||2-Sided|90.0|0.22|1.58||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661335|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.11|Standard Error of the Mean|0.42|||2-Sided|90.0|-0.57|0.8||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661336|NCT01529346|3056587|Superiority or Other||LS Mean Difference|-0.15|Standard Error of the Mean|0.43|||2-Sided|90.0|-0.86|0.56||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661337|NCT01529346|3056587|Superiority or Other||LS Mean Difference|-0.05|Standard Error of the Mean|0.42|||2-Sided|90.0|-0.74|0.64||||||6 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661338|NCT01529346|3056587|Superiority or Other||LS Mean Difference|1.61|Standard Error of the Mean|0.34|||2-Sided|90.0|1.05|2.17||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661339|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.43|Standard Error of the Mean|0.34|||2-Sided|90.0|-0.13|0.98||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661340|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.33|Standard Error of the Mean|0.35|||2-Sided|90.0|-0.24|0.91||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661341|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.49|Standard Error of the Mean|0.34|||2-Sided|90.0|-0.07|1.05||||||4 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661409|NCT01528891|3056646|Superiority or Other||||||<|0.01||||||"P<0.01 for the following time points, 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|t-test, 2 sided|||Heart rate values at each time point were compared between groups.|
1661342|NCT01529346|3056587|Superiority or Other||LS Mean Difference|1.87|Standard Error of the Mean|0.32|||2-Sided|90.0|1.33|2.4||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661343|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.63|Standard Error of the Mean|0.32|||2-Sided|90.0|0.11|1.15||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661344|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.64|Standard Error of the Mean|0.32|||2-Sided|90.0|0.11|1.17||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661345|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.59|Standard Error of the Mean|0.32|||2-Sided|90.0|0.06|1.11||||||3 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661346|NCT01529346|3056587|Superiority or Other||LS Mean Difference|1.79|Standard Error of the Mean|0.32|||2-Sided|90.0|1.26|2.31||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661347|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.45|Standard Error of the Mean|0.3|||2-Sided|90.0|-0.04|0.94||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661348|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.54|Standard Error of the Mean|0.3|||2-Sided|90.0|0.05|1.03||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661349|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.5|Standard Error of the Mean|0.3|||2-Sided|90.0|0.01|0.99||||||2 Hours: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661350|NCT01529346|3056587|Superiority or Other||LS Mean Difference|1.69|Standard Error of the Mean|0.28|||2-Sided|90.0|1.22|2.15||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661351|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.38|Standard Error of the Mean|0.26|||2-Sided|90.0|-0.05|0.81||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661352|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.32|Standard Error of the Mean|0.26|||2-Sided|90.0|-0.1|0.75||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661353|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.39|Standard Error of the Mean|0.26|||2-Sided|90.0|-0.04|0.81||||||90 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661354|NCT01529346|3056587|Superiority or Other||LS Mean Difference|1.3|Standard Error of the Mean|0.27|||2-Sided|90.0|0.85|1.75||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661355|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.25|||2-Sided|90.0|-0.11|0.72||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661356|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.34|Standard Error of the Mean|0.25|||2-Sided|90.0|-0.07|0.76||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661357|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|0.25|||2-Sided|90.0|-0.21|0.62||||||60 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661410|NCT01528605|3056709|Superiority or Other||||||>|0.05|||||||ANOVA|||"The null hypothesis is no group difference"|
1661411|NCT01528605|3056710|Superiority or Other||||||<|0.05|||||||ANOVA|||The null hypothesis was no group difference|
1661358|NCT01529346|3056587|Superiority or Other||LS Mean Difference|1.02|Standard Error of the Mean|0.26|||2-Sided|90.0|0.59|1.45||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661359|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.11|Standard Error of the Mean|0.24|||2-Sided|90.0|-0.29|0.5||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661360|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.39|Standard Error of the Mean|0.24|||2-Sided|90.0|0.0|0.78||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661361|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.02|Standard Error of the Mean|0.24|||2-Sided|90.0|-0.37|0.42||||||45 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661362|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.66|Standard Error of the Mean|0.25|||2-Sided|90.0|0.24|1.07||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661363|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.16|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.22|0.54||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661364|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.39|Standard Error of the Mean|0.23|||2-Sided|90.0|0.01|0.77||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661365|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.06|Standard Error of the Mean|0.23|||2-Sided|90.0|-0.32|0.44||||||30 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661366|NCT01529346|3056587|Superiority or Other||LS Mean Difference|-0.09|Standard Error of the Mean|0.2|||2-Sided|90.0|-0.41|0.24||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661367|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.02|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.28|0.32||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661368|NCT01529346|3056587|Superiority or Other||LS Mean Difference|0.09|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.2|0.39||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661369|NCT01529346|3056587|Superiority or Other||Least Squares (LS) Mean Difference|-0.08|Standard Error of the Mean|0.18|||2-Sided|90.0|-0.38|0.22||||||15 Minutes: repeated measures model included baseline pain intensity, treatment, time, the treatment by time interaction and the time by baseline pain intensity interaction as fixed effects. The unstructured covariance matrix was used to estimate the variances and covariance within participant across time points.|
1661370|NCT01529268|3056590|Superiority||Mean Difference (Final Values)|-2.7||||0.11|2-Sided||||||ANCOVA||||
1661371|NCT01529268|3056591|Superiority|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in parent/guardian-reported Psychosocial Health summary score on treatment group and baseline value of the parent/guardian-reported Psychosocial Health summary score.|Adjusted difference in mean changes|-1.0||||0.85|2-Sided|95.0|-6.0|5.0|||ANCOVA|||Adjusted difference in mean changes from baseline in parent/guardian-reported Psychosocial Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in parent/guardian-reported Psychosocial Health summary score is adjusted for the baseline parent/guardian-reported Psychosocial Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.|
1661372|NCT01529268|3056591|Superiority|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in parent/guardian-reported Physical Health summary score on treatment group and baseline value of the parent/guardian-reported Physical Health summary score.|Adjusted difference in mean changes|-2.0||||0.58|2-Sided|95.0|-9.0|5.0|||ANCOVA|Adjusted for baseline parent/guardian-reported Physical Health summary score.||Adjusted difference in mean changes from baseline in parent/guardian-reported Physical Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in parent/guardian-reported Physical Health summary score is adjusted for the baseline parent/guardian-reported Physical Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.|
1661412|NCT01528605|3056711|Superiority or Other||||||<|0.05|||||||ANOVA|||The null hypothesis was no group difference|
1661373|NCT01529268|3056591|Superiority|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in Pyschosocial Health summary score on treatment group and baseline Psychosocial Health summary score.|Adjusted difference in mean changes|-1.0||||0.64|2-Sided|95.0|-5.0|3.0|||ANCOVA|Adjusted for baseline Psychosocial Health summary score.||Adjusted difference in mean changes from baseline in self-reported Psychosocial Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in Psychosocial Health summary score is adjusted for the baseline Psychosocial Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.|
1661374|NCT01529268|3056591|Superiority|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in self-reported Physical Health summary score on treatment group and baseline value of the Physical Health summary score.|Adjusted difference in mean changes|-1.0||||0.77|2-Sided|95.0|-5.0|3.0|||ANCOVA|Adjusted for baseline self-reported Physical Health summary score.||Adjusted difference in mean changes from baseline in self-reported Physical Health summary score from the Pediatric Quality of Life Inventory (PedsQL). The difference in mean changes in Physical Health summary score is adjusted for the baseline Physical Health summary score; therefore, the adjusted difference in mean changes is not equal to the net change. Higher scores indicate better health-related quality of life.|
1661375|NCT01529268|3056592|Superiority|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in diastolic blood pressure on treatment group and baseline diastolic blood pressure value.|Adjusted difference in mean changes|-1.0||||0.31|2-Sided|95.0|-4.0|1.0|||ANCOVA|Adjusted for baseline diastolic blood pressure.||Adjusted difference in mean changes in diastolic blood pressure. The change in diastolic blood pressure is adjusted for the baseline diastolic blood pressure value; therefore, the adjusted difference in mean changes is not equal to the net change.|
1661376|NCT01529268|3056593|Superiority|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in systolic blood pressure on treatment group and baseline systolic blood pressure value.|Adjusted difference in mean changes|1.0||||0.71|2-Sided|95.0|-3.0|4.0|||ANCOVA|Adjusted for baseline systolic blood pressure.||Adjusted difference in mean changes in systolic blood pressure. The change in systolic blood pressure is adjusted for the baseline systolic blood pressure value; therefore, the adjusted difference in mean changes is not equal to the net change.|
1661377|NCT01529268|3056594|Superiority|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in HOMA-IR on treatment group and baseline HOMA-IR value.|Adjusted difference in mean changes|-2.6||||0.15|2-Sided|95.0|-6.2|1.0|||ANCOVA|Adjusted for baseline HOMA-IR.||Adjusted difference in mean changes in HOMA-IR. The change in HOMA-IR is adjusted for the baseline HOMA-IR value; therefore, the adjusted difference in mean changes is not equal to the net change.|
1661378|NCT01529268|3056595|Superiority|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in fasting insulin on treatment group and baseline fasting insulin.|Adjusted difference in mean changes|-6.0||||0.34|2-Sided|95.0|-18.0|6.0|||ANCOVA|Adjusted for baseline fasting insulin.||Adjusted difference in mean changes in fasting insulin. The change in fasting insulin is adjusted for the baseline fasting insulin value; therefore, the adjusted difference in mean changes is not equal to the net change.|
1661379|NCT01529268|3056596|Non-Inferiority or Equivalence|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in fasting serum glucose on treatment group and baseline fasting serum glucose value.|Adjusted difference in mean changes|-4.0||||0.24|2-Sided|95.0|-11.0|3.0|||ANCOVA|Adjusted for baseline serum glucose value.||Adjusted difference in mean changes in fasting serum glucose. The change in fasting serum glucose is adjusted for the baseline fasting serum glucose value; therefore, the adjusted difference in mean changes is not equal to the net change.|
1661380|NCT01529268|3056597|Superiority|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in waist circumference on treatment group and baseline value of waist circumference.|Adjusted difference in mean changes|0.2||||0.89|2-Sided|95.0|-2.3|2.6|||ANCOVA|Adjusted for baseline waist circumference (cm)||Adjusted difference in mean changes in waist circumference (cm). The change in waist circumference is adjusted for the baseline waist circumference value; therefore, the adjusted difference in mean changes is not equal to the net change.|
1661381|NCT01529268|3056598|Non-Inferiority or Equivalence|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks on treatment group and baseline value of the outcome.|Mean Difference (Net)|-0.1||||0.11|2-Sided|95.0|-0.1|0.0|||ANCOVA||||
1661382|NCT01529268|3056599|Superiority|P-values and differences in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks on treatment group and baseline value of the outcome.|Adjusted difference in mean changes|-0.3||||0.42|2-Sided|95.0|-1.1|0.5|||ANCOVA|Adjusted for baseline BMI (kg/m2)||Adjusted difference in mean changes in body mass index (BMI). The change in BMI is adjusted for the baseline BMI value; therefore, the adjusted difference in mean changes is not equal to the net change.|
1661383|NCT01529268|3056600|Non-Inferiority or Equivalence|P-value and adjusted difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in weight (kg) on treatment group and baseline weight (kg).|Adjusted difference in mean changes|-1.5||||0.25|2-Sided|95.0|-4.1|1.1|||ANCOVA|Adjusted for baseline weight (kg).||Adjusted difference in mean changes in weight (kg). The change in weight is adjusted for the baseline weight value; therefore, the adjusted difference in mean changes is not equal to the net change.|
1661384|NCT01529268|3056601|Superiority|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in gamma-glutamyl transpeptidase on treatment group and baseline value of gamma-glutamyl transpeptidase.|Mean Difference (Net)|-7.0||||0.02|2-Sided|95.0|-13.0|-1.0|||ANCOVA|Adjusted for baseline gamma-glutamyl transpeptidase||Adjusted difference in mean changes in serum gamma-glutamyl transpeptidase (GGT). The change in GGT is adjusted for the baseline GGTvalue; therefore, the adjusted difference in mean changes is not equal to the net change.|
1662896|NCT01499576|3059780|Superiority or Other||persent of adverse event|10.48|||||2-Sided||||||||||
1661385|NCT01529268|3056601|Superiority|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing changes from baseline to 52 weeks in serum aspartate aminotransferase on treatment group and baseline value of serum aspartate aminotransferase.|Mean Difference (Net)|-15.0||||0.008|2-Sided|95.0|-26.0|-4.0|||ANCOVA|Adjusted for baseline serum aspartate aminotransferase.||Adjusted difference in mean changes in serum aspartate aminotransferase (AST). The change in AST is adjusted for the baseline AST value; therefore, the adjusted difference in mean changes is not equal to the net change.|
1661386|NCT01529268|3056601|Superiority|P-value and difference in mean changes from baseline were calculated using ANCOVA models, regressing change from baseline to 52 weeks in serum alanine aminotransferase on treatment group and baseline value of serum alanine aminotransferase.|Adjusted difference in mean changes|-24.0||||0.02|2-Sided|95.0|-44.0|-4.0|||ANCOVA|Adjusted for baseline serum alanine aminotransferase||Adjusted difference in mean changes in serum alanine aminotransferase (ALT). The change in ALT is adjusted for the baseline ALT value; therefore, the adjusted difference in mean changes is not equal to the net change.|
1661387|NCT01529268|3056602|Non-Inferiority|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|2.7||||0.29|2-Sided|95.0|0.4|18.3|||Cochran-Mantel-Haenszel|Stratified by clinic and weight group|||
1661388|NCT01529268|3056603|Superiority|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|-0.2||||0.24|2-Sided|95.0|-0.4|0.1|||ANCOVA||||
1661389|NCT01529268|3056604|Superiority|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.0||||0.98|2-Sided|95.0|0.6|1.6|||Cochran-Mantel-Haenszel||||
1661390|NCT01529268|3056605|Superiority|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.0||||0.76|2-Sided|95.0|-0.2|0.2|||ANCOVA||||
1661391|NCT01529268|3056606|Superiority|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.2||||0.57|2-Sided|95.0|0.6|2.3|||Cochran-Mantel-Haenszel||||
1661392|NCT01529268|3056607|Superiority|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.1||||0.15|2-Sided|95.0|-0.1|0.3|||ANCOVA||||
1661393|NCT01529268|3056608|Superiority|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|0.8||||0.29|2-Sided|95.0|0.4|1.3|||Cochran-Mantel-Haenszel||||
1661394|NCT01529268|3056609|Superiority|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|-0.2||||0.06|2-Sided|95.0|-0.4|0.0|||ANCOVA||||
1661395|NCT01529268|3056610|Superiority|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.8||||0.03|2-Sided|95.0|1.1|2.9|||Cochran-Mantel-Haenszel||||
1661396|NCT01529268|3056611|Non-Inferiority or Equivalence|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.1||||0.59|2-Sided|95.0|-0.2|0.4|||ANCOVA|||Steatosis: change in score|
1661397|NCT01529268|3056612|Superiority|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|0.7||||0.15|2-Sided|95.0|0.5|1.1|||Cochran-Mantel-Haenszel|||Steatosis: patients with improvement|
1661398|NCT01529268|3056613|Superiority|P-values and mean changes from baseline were calculated using ANCOVA, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome, for outcome scores.|Mean Difference (Net)|0.0||||0.9|2-Sided|95.0|-0.6|0.5|||ANCOVA||||
1661399|NCT01529268|3056614|Superiority|Relative risks and p-values were calculated with the Cochran-Mantel-Haenszel chi-square tests, stratified by clinic and weight group, for binary outcomes.|Risk Ratio (RR)|1.3||||0.34|2-Sided|95.0|0.8|2.1|||Cochran-Mantel-Haenszel||||
1661400|NCT01528891|3056643|Superiority or Other||||||<|0.01||||||"P<0.01 for the following time points, as compared to baseline: 4 minutes, 5 minutes, PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||DBP values were compared against the baseline value within each group over time.|
1661401|NCT01528891|3056643|Superiority or Other||||||<|0.01||||||"P<0.01 for the following time points, as compared to baseline: 1 minute, 3 minutes, 4 minutes, 5 minutes, PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||DBP values were compared within each group against the baseline value.|
1661402|NCT01528891|3056643|Superiority or Other||||||<|0.01||||||"P<0.01 for the following time points: 1 minute and PACU.~P-values were adjusted for multiple comparisons."|t-test, 2 sided|||DBP values were compared between groups at each time point.|
1661403|NCT01528891|3056644|Superiority or Other||||||<|0.01||||||"P<0.01 for the following time points, as compared to the baseline value: 5 minutes and PACU.~P-values were adjusted for multiple comparisons."|ANOVA|||SBP values were compared against the baseline within each group over time.|
1661404|NCT01528891|3056644|Superiority or Other||||||<|0.01||||||"P<0.01 for the following time points, as compared to the baseline value: 1 minute, 3 minutes, 4 minutes, and 5 minutes.~P-values are adjusted for multiple comparisons."|ANOVA|||SBP values were compared against the baseline value within each group over time.|
1661405|NCT01528891|3056644|Superiority or Other||||||<|0.01||||||"P<0.01 for the following time points: 1 minute, 4 minutes, 5 minutes, and PACU.~P-values are adjusted for multiple comparisons."|t-test, 2 sided|||Systolic blood pressure values were compared between groups at each time point.|
1661406|NCT01528891|3056645|Superiority or Other||||||<|0.0001||||||P<0.0001 was calculated for both groups.|Fisher Exact|||The incidence of agitated patients in each group was compared.|
1661645|NCT01524783|3057171|Superiority or Other (legacy)||Hazard Ratio (HR)|0.48|||<|0.001|2-Sided|95.0|0.35|0.67|||Log Rank||||
1661414|NCT01528254|3056740|Other||Slope|-5.08|Standard Error of the Mean|1.73||0.003|2-Sided|95.0|-8.46|-1.69|||Mixed Models Analysis|||From Week 13 to end of Period 2|
1661415|NCT01528254|3056740|Other||Slope|-5.03|Standard Error of the Mean|2.16||0.02|2-Sided|95.0|-9.26|-0.79|||Mixed Models Analysis|||From Week 13 to end of Period 1|
1661416|NCT01528254|3056741|Other||Slope|-0.58|Standard Error of the Mean|0.21||0.006|2-Sided|95.0|-0.99|-0.17|||Mixed Models Analysis|||From Week 13 to end of study|
1661417|NCT01528254|3056741|Other||Slope|-0.5|Standard Error of the Mean|0.21||0.017|2-Sided|95.0|-0.91|-0.09|||Mixed Models Analysis|||From Week 13 to end of Period 2|
1661418|NCT01528254|3056741|Other||Slope|-0.08|Standard Error of the Mean|0.23||0.744|2-Sided|95.0|-0.53|0.38|||Mixed Models Analysis|||From Week 13 to end of Period 1|
1661419|NCT01528254|3056742|Other||Slope|0.28|Standard Error of the Mean|0.32||0.381|2-Sided|95.0|-0.35|0.9|||Mixed Models Analysis||||
1661420|NCT01528254|3056743|Other||Slope|-0.01|Standard Error of the Mean|0.02||0.53|2-Sided|95.0|-0.05|0.02|||Mixed Models Analysis||||
1661421|NCT01528254|3056744|Other||Slope|0.09|Standard Error of the Mean|0.19||0.635|2-Sided|95.0|-0.29|0.47|||Mixed Models Analysis||||
1661422|NCT01528254|3056745|Other||Slope|-0.02|Standard Error of the Mean|0.01||0.042|2-Sided|95.0|-0.05|0.0|||Mixed Models Analysis||||
1661423|NCT01528254|3056746|Superiority||Hazard Ratio (HR)|0.51|||<|0.001|2-Sided|95.0|0.45|0.58|||Regression, Cox||||
1661424|NCT01527682|3056761|Other||Proportion|76.7|||||2-Sided|95.0|64.1|89.4|||||||The statistical analysis was performed according to study design. Using a Fleming single stage design (A’Hern approach) setting the probability of erroneously concluding that the responders rate is greater than 35% at 5% (one-sided alpha=0.05) and the probability of correctly concluding that the responders rate is at least 50% at 80% (beta error = 0.20), the minimum number of responder eyes was set at 31 out of 68, since this result is associated with a lower limit of the 90% exact confidence interval of 35.2%.
1661425|NCT01527513|3056763|Non-Inferiority or Equivalence|"A 121ms non-inferiority margin was selected based on a previous study with Cognitive Drug Research (CDR) system comparing newly diagnosed patients to a healthy normative sample.~Assuming a Standard Deviation (SD) of 202.3 for the Power of Attention score, a total of 102 patients in the PP population would provide 80% power to reject the null hypothesis that the mean increase from baseline Power of Attention was at least 121 ms smaller in the placebo group."|95% CI lower bound vs non-inf margin|33.2001|||<|0.7|2-Sided|95.0|-137.593|203.993|||ANCOVA||The predefined non-inferiority margin was -121ms.||
1661426|NCT01527513|3056764|Non-Inferiority or Equivalence|"A 121ms non-inferiority margin was selected based on a previous study with Cognitive Drug Research (CDR) system comparing newly diagnosed patients to a healthy normative sample.~Assuming a Standard Deviation (SD) of 202.3 for the Power of Attention score, a total of 102 patients in the PP population would provide 80% power to reject the null hypothesis that the mean increase from baseline Power of Attention was at least 121 ms smaller in the placebo group."|Mean Difference (Final Values)|33.2001||||0.7|2-Sided|95.0|-137.593|203.993|||95% CI lower bound vs non-inf margin||||
1661427|NCT01527383|3056785|Other||||||<|0.0001|||||||Longitudinal regression|Visit and stratification factor (biologic or non-biologic autoimmune therapy) were covariates|||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is >1.0.
1661428|NCT01527383|3056786|Other||||||<|0.0001|||||||Longitudinal regression|Visit and stratification factor (biologic or non-biologic autoimmune therapy) were covariates|||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is >1.0.
1661429|NCT01527357|3056794|Superiority||||||<|0.0001|||||||Log Rank||||
1661430|NCT01527357|3056795|Superiority||||||<|0.0001|||||||Log Rank||||
1661431|NCT01527357|3056796|Superiority||||||<|0.0001|||||||Log Rank||||
1661432|NCT01527357|3056797|Superiority||||||<|0.0001|||||||Log Rank||||
1661433|NCT01527162|3056804|Superiority or Other||||||=|0|||||||Wilcoxon (Mann-Whitney)||||
1661434|NCT01527162|3056804|Superiority or Other||||||>|0.54|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon Sign Rank TEst|
1661435|NCT01527162|3056805|Superiority or Other||||||=|0|||||||Wilcoxon (Mann-Whitney)||||
1661436|NCT01527162|3056806|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1661437|NCT01526928|3056892|Other||||||||||||||||||Since an MTD was never reached for any of the rociletinib FB or HBr formulations/doses, a 750 mg BID HBr starting dose was selected based on early efficacy data from Phase 1, and enrollment into Phase 2 was initiated at this dosage. As the Phase 1 efficacy data matured, the recommended dose was adjusted to 625 mg BID based on antitumor activity and safety evaluations.
1661438|NCT01526733|3056923|Superiority or Other||Geometric Least Squares Mean Ratio|2.62|||<|0.0001|2-Sided|90.0|2.08|3.29||Comparison of Day 4 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.|Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.|||
1661439|NCT01526733|3056923|Superiority or Other||Geometric Least Squares Mean Ratio|2.15|||<|0.0001|2-Sided|90.0|1.71|2.71||Comparison of Day 1 Insulin (Aspart or Lispro)-rHuPH20 versus Day 1 Insulin-sham.|Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.|||
1661440|NCT01526213|3056936|Superiority or Other||Geometric Mean AUC Ratio (GFJ/mGFJ)|0.96||||0.78|2-Sided|90.0|0.4|1.5|||t-test, 2 sided|||For juice comparisons, fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + grapefruit juice will be the reference standard (denominator).|
1661441|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.98|||||2-Sided|95.0|0.51|1.89|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).|
1661442|NCT01526057|3056941|Superiority||Risk Ratio (RR)|1.8|||||2-Sided|95.0|0.93|3.5|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 21.|
1661443|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.94|||||2-Sided|95.0|0.52|1.69|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 17.|
1661646|NCT01524679|3057181|Superiority||Mean Difference (Final Values)|0.4621||||0.0005|2-Sided|95.0|0.4621|0.7106|||ANCOVA||||
1661444|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.87|||||2-Sided|95.0|0.5|1.5|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 13.|
1661445|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.97|||||2-Sided|95.0|0.51|1.87|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 9.|
1661446|NCT01526057|3056941|Superiority||Risk Ratio (RR)|1.41|||||2-Sided|95.0|0.52|3.86|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 5.|
1661447|NCT01526057|3056941|Superiority||Risk Ratio (RR)|1.79|||||2-Sided|95.0|0.44|7.2|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 3.|
1661448|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.84|||||2-Sided|95.0|0.44|1.62|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).|
1661449|NCT01526057|3056941|Superiority||Risk Ratio (RR)|1.22|||||2-Sided|95.0|0.68|2.19|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.|
1661450|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.93|||||2-Sided|95.0|0.51|1.68|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.|
1661451|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.89|||||2-Sided|95.0|0.51|1.57|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.|
1661452|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.76|||||2-Sided|95.0|0.41|1.4|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.|
1661453|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.71|||||2-Sided|95.0|0.31|1.62|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.|
1661454|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.83|||||2-Sided|95.0|0.27|2.6|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.|
1661455|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.86|||||2-Sided|95.0|0.46|1.63|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).|
1661456|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.68|||||2-Sided|95.0|0.34|1.36|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.|
1661457|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.98|||||2-Sided|95.0|0.56|1.74|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.|
1661458|NCT01526057|3056941|Superiority||Risk Ratio (RR)|1.03|||||2-Sided|95.0|0.61|1.74|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.|
1661459|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.78|||||2-Sided|95.0|0.43|1.41|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.|
1661460|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.5|||||2-Sided|95.0|0.2|1.26|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.|
1661461|NCT01526057|3056941|Superiority||Risk Ratio (RR)|0.47|||||2-Sided|95.0|0.12|1.79|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.|
1661462|NCT01526057|3056942|Superiority||Risk Ratio (RR)|1.1|||||2-Sided|95.0|0.7|1.73|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).|
1661463|NCT01526057|3056942|Superiority||Risk Ratio (RR)|1.29|||||2-Sided|95.0|0.85|1.95|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 21.|
1661464|NCT01526057|3056942|Superiority||Risk Ratio (RR)|0.86|||||2-Sided|95.0|0.55|1.36|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 17.|
1661465|NCT01526057|3056942|Superiority||Risk Ratio (RR)|0.74|||||2-Sided|95.0|0.48|1.13|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 13.|
1661466|NCT01526057|3056942|Superiority||Risk Ratio (RR)|0.78|||||2-Sided|95.0|0.47|1.31|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 9.|
1661467|NCT01526057|3056942|Superiority||Risk Ratio (RR)|0.77|||||2-Sided|95.0|0.41|1.44|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 5.|
1661468|NCT01526057|3056942|Superiority||Risk Ratio (RR)|0.94|||||2-Sided|95.0|0.36|2.45|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-EU at Week 3.|
1661469|NCT01526057|3056942|Superiority||Risk Ratio (RR)|1.31|||||2-Sided|95.0|0.78|2.18|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).|
1661470|NCT01526057|3056942|Superiority||Risk Ratio (RR)|1.36|||||2-Sided|95.0|0.88|2.1|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.|
1661471|NCT01526057|3056942|Superiority||Risk Ratio (RR)|0.9|||||2-Sided|95.0|0.57|1.44|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.|
1661472|NCT01526057|3056942|Superiority||Risk Ratio (RR)|0.79|||||2-Sided|95.0|0.5|1.22|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.|
1661473|NCT01526057|3056942|Superiority||Risk Ratio (RR)|0.83|||||2-Sided|95.0|0.49|1.42|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.|
1661474|NCT01526057|3056942|Superiority||Risk Ratio (RR)|0.81|||||2-Sided|95.0|0.43|1.54|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.|
1661475|NCT01526057|3056942|Superiority||Risk Ratio (RR)|0.7|||||2-Sided|95.0|0.28|1.73|||||Rituximab-US is the numerator.|Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.|
1661476|NCT01526057|3056942|Superiority||Risk Ratio (RR)|1.19|||||2-Sided|95.0|0.7|2.0|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).|
1661477|NCT01526057|3056942|Superiority||Risk Ratio (RR)|1.05|||||2-Sided|95.0|0.66|1.69|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.|
1661478|NCT01526057|3056942|Superiority||Risk Ratio (RR)|1.05|||||2-Sided|95.0|0.68|1.62|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.|
1661647|NCT01524679|3057182|Superiority||Mean Difference (Final Values)|0.7525||||0.0957|2-Sided|95.0|0.5382|1.0521|||ANCOVA||||
1661479|NCT01526057|3056942|Superiority||Risk Ratio (RR)|1.06|||||2-Sided|95.0|0.73|1.56|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.|
1661480|NCT01526057|3056942|Superiority||Risk Ratio (RR)|1.06|||||2-Sided|95.0|0.66|1.73|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.|
1661481|NCT01526057|3056942|Superiority||Risk Ratio (RR)|1.06|||||2-Sided|95.0|0.6|1.88|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.|
1661482|NCT01526057|3056942|Superiority||Risk Ratio (RR)|0.75|||||2-Sided|95.0|0.31|1.78|||||Rituximab-EU is the numerator.|Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.|
1661483|NCT01526057|3056961|Superiority||Test-to-reference ratio: adjusted means|98.03|||||2-Sided|90.0|87.83|109.4||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.|
1661484|NCT01526057|3056961|Superiority||Test-to-reference ratio: adjusted means|101.33|||||2-Sided|90.0|90.82|113.04||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.|
1661485|NCT01526057|3056961|Superiority||Test-to-reference ratio: adjusted means|103.36|||||2-Sided|90.0|92.81|115.12||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.|
1661486|NCT01526057|3056962|Superiority||Test-to-reference ratio: adjusted means|101.76|||||2-Sided|90.0|93.13|111.18|||||Rituximab-EU is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data.|
1661487|NCT01526057|3056962|Superiority||Test-to-reference ratio: adjusted means|105.56|||||2-Sided|90.0|96.64|115.3|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.|
1661488|NCT01526057|3056962|Superiority||Test-to-reference ratio: adjusted means|103.74|||||2-Sided|90.0|95.1|113.12|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.|
1661489|NCT01526057|3056963|Equivalence|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|96.4|||||2-Sided|90.0|85.57|108.6||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.|
1661490|NCT01526057|3056963|Equivalence|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|100.45|||||2-Sided|90.0|89.2|113.11||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.|
1661491|NCT01526057|3056963|Equivalence|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|104.19|||||2-Sided|90.0|92.75|117.06||||||A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.|
1661492|NCT01526057|3056964|Equivalence|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|100.9|||||2-Sided|90.0|92.38|110.2|||||Rituximab-EU is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.|
1661493|NCT01526057|3056964|Equivalence|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|106.62|||||2-Sided|90.0|97.65|116.41|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.|
1661494|NCT01526057|3056964|Equivalence|PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC 0-inf) are within the 80.00% to 125.00% range.|Test-to-reference ratio: adjusted means|105.67|||||2-Sided|90.0|96.91|115.21|||||Rituximab-Pfizer is the numerator.|A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way analysis of variance (ANOVA) model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.|
1661495|NCT01525849|3056978|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1661496|NCT01525849|3056980|Superiority or Other|||||||0.628|||||||t-test, 2 sided||||
1661497|NCT01525849|3056981|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided|||Test for superiority of balloon dilation over FESS. Significance level=0.025 (1-sided alpha), power=90%, BD estimate=0.5, FESS estimate=1.5, SD for both arms=1.0. A total sample size of 46 participants (23 per arm) was required to test the hypothesis.|
1661498|NCT01525849|3056982|Non-Inferiority or Equivalence|Significance level=0.025 (1-sided alpha), power=90%, delta=0.8, true difference=0, SD for both arms=1.0. A total sample size of 72 participants (36 per arm) was required to test the hypothesis.|||||<|0.001|||||||t-test, 1 sided|||Non-inferiority test to demonstrate that the long-term (1-year) change in sinus symptoms (overall SNOT-20 score) after balloon dilation is not worse than after FESS.|
1661499|NCT01525667|3056988|Superiority or Other||LSM difference|10.7|Standard Error of the Mean|9.01||0.24|2-Sided|95.0|-7.26|28.65|||Mixed Models Analysis||||
1661500|NCT01525667|3056988|Superiority or Other||LSM difference|16.81|Standard Error of the Mean|8.37||0.05|2-Sided|95.0|0.16|33.47|||Mixed Models Analysis||||
1661501|NCT01525667|3056989|Superiority or Other||Mean Difference (Net)|0.011|Standard Error of the Mean|0.2||0.96|2-Sided||||||Mixed Models Analysis||||
1661502|NCT01525667|3056989|Superiority or Other||Mean Difference (Net)|0.16|Standard Error of the Mean|0.19||0.4|2-Sided|95.0|-0.21|0.53|||Mixed Models Analysis||||
1661503|NCT01525667|3056990|Superiority or Other||LSM difference|5.49|Standard Error of the Mean|4.56||0.25|2-Sided|95.0|-4.29|15.26|||ANCOVA||||
1661504|NCT01525667|3056990|Superiority or Other||LSM Difference|6.45|Standard Error of the Mean|4.64||0.19|2-Sided|95.0|-3.5|16.41|||ANCOVA||||
1661505|NCT01525667|3056991|Superiority or Other||LSM difference|9.23|Standard Error of the Mean|6.91||0.19|2-Sided|95.0|-4.72|23.17|||Mixed Models Analysis||||
1661506|NCT01525667|3056991|Superiority or Other||LSM Difference|18.03|Standard Error of the Mean|5.97||0.004|2-Sided|95.0|6.03|30.02|||Mixed Models Analysis||||
1661507|NCT01525667|3056992|Superiority or Other||Least Square Means (LSM) difference|14.93|Standard Error of the Mean|10.8||0.18|2-Sided|95.0|-7.12|36.99|||Mixed Models Analysis||LSM difference= LSM High Dose - LSM Placebo||
1661508|NCT01525667|3056992|Superiority or Other||Least Square Means (LSM) Difference|25.74|Standard Error of the Mean|8.94||0.0067|2-Sided|95.0|7.61|43.86|||Mixed Models Analysis||LSM difference =LSM Low dose - LSM Placebo||
1661509|NCT01525628|3057006|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|78.42|Standard Deviation|36.3||0.5575|2-Sided|90.0|61.81|99.51|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661510|NCT01525628|3057006|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|87.59|Standard Deviation|31.8||0.1898|2-Sided|90.0|73.56|104.3|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661511|NCT01525628|3057006|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|108.25|Standard Deviation|37.2||0.1286|2-Sided|90.0|87.46|133.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661512|NCT01525628|3057006|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|78.29|Standard Deviation|34.3||0.5658|2-Sided|90.0|62.5|98.07|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661513|NCT01525628|3057006|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|99.99|Standard Deviation|38.7||0.0651|2-Sided|90.0|78.33|127.64|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661514|NCT01525628|3057006|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|102.7|Standard Deviation|45.9||0.1159|2-Sided|90.0|77.89|135.39|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661515|NCT01525628|3057007|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|70.14|Standard Deviation|34.3||0.8547|2-Sided|90.0|56.84|86.56|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661516|NCT01525628|3057007|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|75.19|Standard Deviation|30.3||0.7367|2-Sided|90.0|63.64|88.82|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661596|NCT01525615|3057032|Superiority or Other||LSMean Difference-Final Values|0.0|Standard Error of the Mean|0.001||0.6549|2-Sided|95.0|-0.002|0.003||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661517|NCT01525628|3057007|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|95.55|Standard Deviation|29.2||0.0432|2-Sided|90.0|80.63|113.24|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661518|NCT01525628|3057007|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|92.11|Standard Deviation|32.6||0.1326|2-Sided|90.0|74.38|114.07|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of 1-OH-Midazolam at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661519|NCT01525628|3057007|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|117.01|Standard Deviation|30.9||0.2827|2-Sided|90.0|96.06|142.52|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of 1-OH-Midazolam at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day17 vs. Day 1|
1661520|NCT01525628|3057007|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|117.67|Standard Deviation|15.6||0.1519|2-Sided|90.0|106.49|130.0|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of 1-OH-Midazolam at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661521|NCT01525628|3057008|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|87.77|Standard Deviation|36.9||0.2372|2-Sided|90.0|70.32|109.54|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661522|NCT01525628|3057008|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|130.44|Standard Deviation|35.3||0.647|2-Sided|90.0|107.57|158.18|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661523|NCT01525628|3057008|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|122.58|Standard Deviation|37.2||0.4374|2-Sided|90.0|99.15|151.55|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661524|NCT01525628|3057008|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|98.14|Standard Deviation|28.1||0.0392|2-Sided|90.0|81.2|118.63|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of Midazolam at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661525|NCT01525628|3057008|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|163.42|Standard Deviation|26.0||0.9926|2-Sided|90.0|137.91|193.64|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of Midazolam at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661526|NCT01525628|3057008|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|151.66|Standard Deviation|18.5||0.9941|2-Sided|90.0|134.79|170.64|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of Midazolam at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661527|NCT01525628|3057009|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|93.95|Standard Deviation|25.2||0.046|2-Sided|90.0|80.33|109.86|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Midazolam at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661528|NCT01525628|3057009|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|120.74|Standard Deviation|19.2||0.2906|2-Sided|90.0|108.47|134.38|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Midazolam at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661597|NCT01525615|3057032|Superiority or Other||LSMean Difference-Final Values|-0.003|Standard Error of the Mean|0.001||0.0218|2-Sided|95.0|-0.005|0.0||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661707|NCT01522755|3057332|Other|t-test|||||<|0.05|||||||t-test, 2 sided||||
1661529|NCT01525628|3057009|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|124.22|Standard Deviation|24.1||0.4697|2-Sided|90.0|107.91|142.99|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Midazolam at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661530|NCT01525628|3057009|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|102.99|Standard Deviation|29.3||0.05|2-Sided|90.0|84.85|124.99|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of Midazolam at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661531|NCT01525628|3057009|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|152.94|Standard Deviation|26.8||0.9703|2-Sided|90.0|128.6|181.89|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of Midazolam at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661532|NCT01525628|3057009|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|144.78|Standard Deviation|19.0||0.9749|2-Sided|90.0|128.3|163.36|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of Midazolam at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661533|NCT01525628|3057010|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|63.75|Standard Deviation|17.3||0.9988|2-Sided|90.0|57.19|71.07|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661534|NCT01525628|3057010|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|64.66|Standard Deviation|11.8||1|2-Sided|90.0|60.42|69.2|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661535|NCT01525628|3057010|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|86.37|Standard Deviation|18.1||0.1144|2-Sided|90.0|77.62|96.11|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661536|NCT01525628|3057010|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|70.93|Standard Deviation|22.6||0.8975|2-Sided|90.0|60.44|83.22|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661537|NCT01525628|3057010|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|81.26|Standard Deviation|11.7||0.3638|2-Sided|90.0|75.19|87.82|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661538|NCT01525628|3057010|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|98.17|Standard Deviation|12.3||0.0005|2-Sided|90.0|90.15|106.91|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661539|NCT01525628|3057011|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|75.42|Standard Deviation|16.4||0.8378|2-Sided|90.0|68.15|83.45|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661540|NCT01525628|3057011|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|73.93|Standard Deviation|21.6||0.8646|2-Sided|90.0|65.55|83.39|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661541|NCT01525628|3057011|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|92.23|Standard Deviation|10.5||0.0005|2-Sided|90.0|86.67|98.13|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661542|NCT01525628|3057011|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|73.26|Standard Deviation|17.5||0.893|2-Sided|90.0|65.03|82.54|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of tolbutamide at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661543|NCT01525628|3057011|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|85.41|Standard Deviation|17.2||0.1617|2-Sided|90.0|76.32|95.57|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of tolbutamide at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661544|NCT01525628|3057011|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|96.06|Standard Deviation|14.2||0.0015|2-Sided|90.0|87.77|105.13|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of tolbutamide at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661545|NCT01525628|3057012|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|214.4|Standard Deviation|66.8||0.9865|2-Sided|90.0|145.88|315.09|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661546|NCT01525628|3057012|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|219.88|Standard Deviation|70.4||0.9933|2-Sided|90.0|153.84|314.26|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661547|NCT01525628|3057012|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|163.95|Standard Deviation|38.1||0.9689|2-Sided|90.0|129.52|207.52|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661548|NCT01525628|3057012|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|259.57|Standard Deviation|92.5||0.983|2-Sided|90.0|150.65|447.21|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of caffeine at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661549|NCT01525628|3057012|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|159.11|Standard Deviation|57.8||0.8723|2-Sided|90.0|111.06|227.93|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of caffeine at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661550|NCT01525628|3057012|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|88.37|Standard Deviation|20.8||0.1037|2-Sided|90.0|77.39|100.89|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of caffeine at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661551|NCT01525628|3057013|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|121.43|Standard Deviation|24.7||0.3719|2-Sided|90.0|104.24|141.45|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of caffeine at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661552|NCT01525628|3057013|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|122.37|Standard Deviation|29.3||0.4111|2-Sided|90.0|104.11|143.84|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of caffeine at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661553|NCT01525628|3057013|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|139.07|Standard Deviation|22.8||0.9082|2-Sided|90.0|121.63|159.0|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of caffeine at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661554|NCT01525628|3057013|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 1 (%)|114.38|Standard Deviation|31.9||0.2375|2-Sided|90.0|92.36|141.66|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of caffeine at Day 66 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 1|
1661555|NCT01525628|3057013|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 1 (%)|97.1|Standard Deviation|31.2||0.0564|2-Sided|90.0|79.37|118.79|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of caffeine at Day 17 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 1|
1661556|NCT01525628|3057013|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 9 vs. Day 1 (%)|97.03|Standard Deviation|30.8||0.05|2-Sided|90.0|80.0|117.69|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of caffeine at Day 9 vs. Day 1 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 9 vs. Day 1|
1661557|NCT01525628|3057014|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|377.98|Standard Deviation|82.0||0.9994|2-Sided|90.0|233.48|611.91|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661558|NCT01525628|3057014|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|606.29|Standard Deviation|44.2||1|2-Sided|90.0|471.42|779.74|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661559|NCT01525628|3057015|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|441.89|Standard Deviation|66.9||0.9999|2-Sided|90.0|286.81|680.82|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661560|NCT01525628|3057015|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|569.81|Standard Deviation|42.2||1|2-Sided|90.0|447.49|725.57|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661561|NCT01525628|3057016|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|384.0|Standard Deviation|69.2||0.9998|2-Sided|90.0|251.56|586.16|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI CD 6168-ag at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661562|NCT01525628|3057016|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|528.95|Standard Deviation|42.0||1|2-Sided|90.0|415.88|672.75|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI CD 6168-ag at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661563|NCT01525628|3057017|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|298.57|Standard Deviation|79.2||0.9972|2-Sided|90.0|187.22|476.15|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661564|NCT01525628|3057017|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|466.92|Standard Deviation|47.6||1|2-Sided|90.0|357.02|610.66|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661565|NCT01525628|3057018|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|341.96|Standard Deviation|61.1||0.9996|2-Sided|90.0|229.22|510.13|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661566|NCT01525628|3057018|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|450.51|Standard Deviation|48.0||1|2-Sided|90.0|343.67|590.57|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661598|NCT01525615|3057032|Superiority or Other||LSMean Difference-Final Values|-0.002|Standard Error of the Mean|0.001||0.0598|2-Sided|95.0|-0.004|0.0||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661763|NCT01522391|3057388|Other||Ratio between geometric means|0.045||||0.009|2-Sided|95.0|0.005|0.447|||Mixed Models Analysis|||Day 14|
1661567|NCT01525628|3057019|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|301.19|Standard Deviation|62.1||0.9993|2-Sided|90.0|204.61|443.35|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI CD 6168 at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661568|NCT01525628|3057019|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|408.66|Standard Deviation|45.9||1|2-Sided|90.0|315.15|529.9|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI CD 6168 at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661569|NCT01525628|3057020|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|116.96|Standard Deviation|73.1||0.3968|2-Sided|90.0|75.38|181.47|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661570|NCT01525628|3057020|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|403.86|Standard Deviation|33.6||1|2-Sided|90.0|332.19|490.99|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661571|NCT01525628|3057021|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|142.27|Standard Deviation|53.1||0.7346|2-Sided|90.0|99.49|203.44|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661572|NCT01525628|3057021|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|397.73|Standard Deviation|31.6||1|2-Sided|90.0|330.79|478.22|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661573|NCT01525628|3057022|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|120.67|Standard Deviation|58.3||0.4337|2-Sided|90.0|83.68|174.01|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 208833 at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661574|NCT01525628|3057022|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|355.04|Standard Deviation|29.9||1|2-Sided|90.0|298.13|422.83|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 208833 at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661575|NCT01525628|3057023|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|145.93|Standard Deviation|66.2||0.7461|2-Sided|90.0|97.83|217.69|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661576|NCT01525628|3057023|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|322.68|Standard Deviation|40.4||1|2-Sided|90.0|256.24|406.34|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661577|NCT01525628|3057024|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|176.56|Standard Deviation|50.1||0.9533|2-Sided|90.0|125.95|247.5|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661578|NCT01525628|3057024|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|349.9|Standard Deviation|46.4||1|2-Sided|90.0|269.12|454.93|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661579|NCT01525628|3057025|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|150.45|Standard Deviation|55.1||0.821|2-Sided|90.0|106.81|211.91|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 207127 at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661580|NCT01525628|3057025|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|286.01|Standard Deviation|39.4||1|2-Sided|90.0|228.51|357.97|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 207127 at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661581|NCT01525628|3057026|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|129.85|Standard Deviation|32.5||0.6185|2-Sided|90.0|104.26|161.71|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661582|NCT01525628|3057026|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|306.45|Standard Deviation|30.7||1|2-Sided|90.0|250.93|374.26|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661583|NCT01525628|3057027|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|123.65|Standard Deviation|40.0||0.4718|2-Sided|90.0|94.66|161.51|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661584|NCT01525628|3057027|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|381.11|Standard Deviation|28.1||1|2-Sided|90.0|317.01|458.19|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661585|NCT01525628|3057028|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 66 vs. Day 9 (%)|131.3|Standard Deviation|32.5||0.6514|2-Sided|90.0|105.4|163.57|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 201335 at Day 66 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 66 vs. Day 9|
1661586|NCT01525628|3057028|Non-Inferiority or Equivalence|p-value for ratio outside 80% to 125%|Ratio of gmeans Day 17 vs. Day 9 (%)|251.37|Standard Deviation|31.0||1|2-Sided|90.0|205.54|307.43|||ANOVA|"ANOVA (analysis of variance) model on the logarithm scale was used with~‘subject’ as random, whereas the ‘treatment’ as fixed effect."|Relative bioavailability of BI 201335 at Day 17 vs. Day 9 −was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually Intra individual geometric coefficient variation (gCV).|Day 17 vs. Day 9|
1661587|NCT01525615|3057029|Superiority or Other||LSMean Difference-Final Values|-0.006|Standard Error of the Mean|0.027||0.8156|2-Sided|95.0|-0.06|0.047||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661588|NCT01525615|3057029|Superiority or Other||LSMean Difference-Final Values|0.257|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.202|0.312||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661589|NCT01525615|3057029|Superiority or Other||LSMean Difference-Final Values|0.251|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.196|0.305||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661590|NCT01525615|3057030|Superiority or Other||LSMean Difference-Final Values|-0.027|Standard Error of the Mean|0.027||0.3236|2-Sided|95.0|-0.08|0.027||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661591|NCT01525615|3057030|Superiority or Other||LSMean Difference-Final Values|0.273|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.218|0.328||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661592|NCT01525615|3057030|Superiority or Other||LSMean Difference-Final Values|0.246|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.192|0.3||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661593|NCT01525615|3057031|Superiority or Other||LSMean Difference-Final Values|-0.014|Standard Error of the Mean|0.027||0.6105|2-Sided|95.0|-0.067|0.04||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661594|NCT01525615|3057031|Superiority or Other||LSMean Difference-Final Values|0.184|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.129|0.239||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661595|NCT01525615|3057031|Superiority or Other||LSMean Difference-Final Values|0.17|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.116|0.224||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661641|NCT01524887|3057152|Superiority or Other||Difference in least square means|1.4||||0.243||95.0|-1.0|3.9|||Mixed Models Analysis||||
1661642|NCT01524796|3057160|Superiority or Other||||||<|0.001|||||||Wilcoxon signed-rank test||||
1661599|NCT01525615|3057033|Superiority or Other||LSMean Difference-Final Values|0.0|Standard Error of the Mean|0.001||0.9626|2-Sided|95.0|-0.002|0.002||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661600|NCT01525615|3057033|Superiority or Other||LSMean Difference-Final Values|-0.003|Standard Error of the Mean|0.001||0.0099|2-Sided|95.0|-0.005|-0.001||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661601|NCT01525615|3057033|Superiority or Other||LSMean Difference-Final Values|-0.003|Standard Error of the Mean|0.001||0.0081|2-Sided|95.0|-0.005|-0.001||MMRM model with fixed effects of treatment, test day, treatment by test day interaction, baseline, baseline by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661602|NCT01525615|3057034|Superiority or Other||LSMean Difference-Final Values|0.0|Standard Error of the Mean|0.001||0.6856|2-Sided|95.0|-0.002|0.002||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive|||
1661603|NCT01525615|3057034|Superiority or Other||LSMean Difference-Final Values|-0.002|Standard Error of the Mean|0.001||0.018|2-Sided|95.0|-0.005|0.0||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive|||
1661604|NCT01525615|3057034|Superiority or Other||LSMean Difference-Final Values|-0.002|Standard Error of the Mean|0.001||0.0468|2-Sided|95.0|-0.004|0.0||ANCOVA model for mean slope of the intensity of breathing discomfort with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive|||
1661605|NCT01525615|3057035|Superiority or Other||LSMean Difference-Final Values|0.038|Standard Error of the Mean|0.05||0.4541|2-Sided|95.0|-0.061|0.137||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661606|NCT01525615|3057035|Superiority or Other||LSMean Difference-Final Values|0.187|Standard Error of the Mean|0.052||0.0003|2-Sided|95.0|0.086|0.288||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661607|NCT01525615|3057035|Superiority or Other||LSMean Difference-Final Values|0.225|Standard Error of the Mean|0.051|<|0.0001|2-Sided|95.0|0.124|0.326||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|Descriptive|||
1661608|NCT01525615|3057036|Superiority or Other||LSMean Difference-Final Values|-0.037|Standard Error of the Mean|0.058||0.5162|2-Sided|95.0|-0.151|0.076||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive|||
1661609|NCT01525615|3057036|Superiority or Other||LSMean Difference-Final Values|0.202|Standard Error of the Mean|0.058||0.0006|2-Sided|95.0|0.088|0.316||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive|||
1661610|NCT01525615|3057036|Superiority or Other||LSMean Difference-Final Values|0.165|Standard Error of the Mean|0.058||0.0049|2-Sided|95.0|0.051|0.279||ANCOVA model for inspiratory capacity (liters) with categorical effect of treatment and baseline as continuous covariate.|ANCOVA|Descriptive|||
1661611|NCT01525615|3057037|Superiority or Other||Treatment ratio|1.006|Standard Error of the Mean|0.055||0.9062|2-Sided|95.0|0.905|1.12||MMRM model for log10 (endurance time [s]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time [s]), log10 (baseline endurance time [s]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. Hypothesis test is descriptive.|
1661612|NCT01525615|3057037|Superiority or Other||Treatment ratio|1.221|Standard Error of the Mean|0.068||0.0004|2-Sided|95.0|1.095|1.362||MMRM model for log10 (endurance time [s]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time [s]), log10 (baseline endurance time [s]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo. Hypothesis test is descriptive.|
1661613|NCT01525615|3057037|Superiority or Other||Treatment ratio|1.229|Standard Error of the Mean|0.068||0.0002|2-Sided|95.0|1.103|1.37||MMRM model for log10 (endurance time [s]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time [s]), log10 (baseline endurance time [s]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. Hypothesis test is descriptive|
1661614|NCT01525615|3057038|Superiority or Other||Treatment ratio|1.021|Standard Error of the Mean|0.053||0.6912|2-Sided|95.0|0.921|1.132|||ANCOVA|Descriptive||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0|
1661615|NCT01525615|3057038|Superiority or Other||Treatment ratio|1.103|Standard Error of the Mean|0.058||0.0655|2-Sided|95.0|0.994|1.223|||ANCOVA|Descriptive||Treatment ratio between Tio+Olo 2.5/5.0 and placebo|
1661616|NCT01525615|3057038|Superiority or Other||Treatment ratio|1.126|Standard Error of the Mean|0.059||0.0245|2-Sided|95.0|1.015|1.248||ANCOVA model for log10 (endurance time [s]) with categorical effects of treatment and (log10-transformed) baseline as continuous covariate.|ANCOVA|This hypothesis test is descriptive.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo|
1661617|NCT01525615|3057039|Superiority or Other||LSMean Difference-Final Values|0.027|Standard Error of the Mean|0.05||0.5892|2-Sided|95.0|-0.072|0.126||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.|||
1661643|NCT01524796|3057161|Superiority or Other||||||<|0.001|||||||Wilcoxon signed-rank test||||
1661618|NCT01525615|3057039|Superiority or Other||LSMean Difference-Final Values|0.207|Standard Error of the Mean|0.052|<|0.0001|2-Sided|95.0|0.105|0.309||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.|||
1661619|NCT01525615|3057039|Superiority or Other||LSMean Difference-Final Values|0.234|Standard Error of the Mean|0.052|<|0.0001|2-Sided|95.0|0.133|0.336||MMRM model for inspiratory capacity with fixed effects of treatment, test day, treatment by test day interaction, baseline inspiratory capacity, baseline inspiratory capacity by test day interaction, and patient as a random effect.|Mixed Models Analysis|This hypothesis test is descriptive.|LSMean=Least square mean.||
1661620|NCT01525615|3057040|Superiority or Other||Treatment ratio|0.998|Standard Error of the Mean|0.095||0.9822|2-Sided|95.0|0.826|1.205||MMRM model for log10 (endurance time [s]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time [s]), log10 (baseline endurance time [s]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. This treatment comparison is not included in the alpha-protected hierarchical testing chain.|
1661621|NCT01525615|3057040|Superiority or Other||Treatment ratio|1.211|Standard Error of the Mean|0.121||0.0562|2-Sided|95.0|0.995|1.475||MMRM model for log10 (endurance time [s]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time [s]), log10 (baseline endurance time [s]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean, 95% confidence limits transformed from log10 to original scale. SE was calculated using the delta method. This hypothesis test is descriptive.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo|
1661622|NCT01525615|3057040|Superiority or Other||Tretament ratio|1.209|Standard Error of the Mean|0.119||0.0552|2-Sided|95.0|0.996|1.467||MMRM model for log10 (endurance time [s]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time [s]), log10 (baseline endurance time [s]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. Since the hierarchical testing chain has been broken, even though this treatment comparison is included as the 3rd one in the alpha-protected hierarchical testing chain, this hypothesis test is descriptive only.|
1661623|NCT01525615|3057041|Superiority or Other||Treatment ratio|1.047|Standard Error of the Mean|0.057||0.397|2-Sided|95.0|0.941|1.166||MMRM model for log10 (endurance time [s]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time [s]), log10 (baseline endurance time [s]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and Tio+Olo 2.5/5.0. This treatment comparison is not included in the alpha-protected hierarchical testing chain.|
1661624|NCT01525615|3057041|Superiority or Other||Treatment ratio|1.086|Standard Error of the Mean|0.061||0.1419|2-Sided|95.0|0.973|1.213||MMRM model for log10 (endurance time [s]) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time [s]), log10 (baseline endurance time [s]) by test day interaction, patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 2.5/5.0 and placebo. This treatment comparison is the second one in the alpha-protected hierarchical testing chain. Since the p-value for this treatment comparison is >0.05, the hierarchical testing chain is broken and all of the following hypothesis tests in this hierarchical chain are considered as descriptive only.|
1661625|NCT01525615|3057041|Superiority or Other||Treatment ratio|1.138|Standard Error of the Mean|0.063||0.0209|2-Sided|95.0|1.02|1.269||Mixed effects Model for Repeated Measures (MMRM) with fixed effects of treatment, test day, treatment by test day interaction, log10 (baseline endurance time), log10 (baseline endurance time) by test day interaction, and patient as a random effect.|Mixed Models Analysis|Mean and 95% confidence limits were transformed from log10 back to the original scale. SE was calculated using the delta method.||Treatment ratio between Tio+Olo 5.0/5.0 and placebo. This treatment comparison is the first one in the alpha-protected hierarchical testing chain.|
1661626|NCT01525329|3057089|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1661627|NCT01525329|3057089|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1661628|NCT01525329|3057090|Superiority or Other|||||||0.08|||||||t-test, 2 sided||||
1661629|NCT01525329|3057090|Superiority or Other||||||<|0.007|||||||t-test, 2 sided||||
1661630|NCT01524887|3057147|Superiority or Other||Difference in least square means|0.0||||0.981||95.0|-2.0|2.0|||Mixed Models Analysis||||
1661631|NCT01524887|3057147|Superiority or Other||Difference in least square means|-0.5||||0.633||95.0|-2.8|1.7|||Mixed Models Analysis||||
1661632|NCT01524887|3057148|Superiority or Other||Difference in least square means|0.00003||||0.94||95.0|-0.0008|0.00086|||ANCOVA||||
1661633|NCT01524887|3057148|Superiority or Other||Difference in least square means|-0.00026||||0.593||95.0|-0.00126|0.00073|||ANCOVA||||
1661634|NCT01524887|3057149|Superiority or Other||Difference in least square means|3.7||||0.032||95.0|0.3|7.1|||Mixed Models Analysis||||
1661635|NCT01524887|3057149|Superiority or Other||Difference in least square means|1.1||||0.571||95.0|-2.6|4.7|||Mixed Models Analysis||||
1661636|NCT01524887|3057150|Superiority or Other||Difference in least square means|-0.1||||0.783||95.0|-0.7|0.5|||Mixed Models Analysis||||
1661637|NCT01524887|3057150|Superiority or Other||Difference in least square means|-0.2||||0.501||95.0|-1.0|0.5|||Mixed Models Analysis||||
1661638|NCT01524887|3057151|Superiority or Other||Difference in least square means|-0.9||||0.586||95.0|-4.2|2.4|||Mixed Models Analysis||||
1661639|NCT01524887|3057151|Superiority or Other||Difference in least square means|-3.9||||0.033||95.0|-7.4|-0.3|||Mixed Models Analysis||||
1661640|NCT01524887|3057152|Superiority or Other||Difference in least square means|1.0||||0.37||95.0|-1.2|3.3|||Mixed Models Analysis||||
1661648|NCT01524679|3057183|Superiority|The Fisher Test with asymptotic test statistic provided by the analysis software was used.|||||<|0.0001||||||This was the only a priori defined primary endpoint. There was no adjustment for multiple comparisons.|Fisher Exact|There was no adjustment for other variables intended for the primary analysis. Confounding variables were analysed in subsequent analyses.||Nullhypothesis was the equality of response rates of the treatment group and the control group. Treatments were compared by a two-sided Fisher test on a level of significance of 0.05. The study was appropriately powered (80%) for this analysis.|
1661649|NCT01524627|3057184|Superiority|||||||0.1|||||||t-test, 2 sided||||
1661650|NCT01524627|3057184|Superiority|||||||0.0004|||||||t-test, 2 sided||||
1661651|NCT01524289|3057190|Superiority||Median Difference (Final Values)|-27.9|||<|0.001|2-Sided|95.0|-34.7|-21.2|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate of the median difference between treatments with a corresponding distribution-free confidence interval (CI) based on Wilcoxon's rank sum test.||
1661652|NCT01524289|3057191|Superiority||Difference in LS Means|32.9|||<|0.001|2-Sided|95.0|28.2|37.6|||Constrained Longitudinal Data Analysis||||
1661653|NCT01524289|3057192|Superiority||Difference in LS Means|-24.8|||<|0.001|2-Sided|95.0|-29.5|-20.1|||Constrained Longitudinal Data Analysis||||
1661654|NCT01524289|3057193|Superiority||Difference in LS Means|-36.4|||<|0.001|2-Sided|95.0|-41.7|-31.1|||Constrained Longitudinal Data Analysis||||
1661655|NCT01524289|3057194|Superiority||Difference in Least Squares (LS) Means|102.1|||<|0.001|2-Sided|95.0|94.2|110.1|||Constrained Longitudinal Data Analysis||||
1661656|NCT01524289|3057195|Other|Pre-specified|Difference in Percentages|0.0|||>|0.999|2-Sided|95.0|-3.6|1.9|||Miettinen and Nurminen||||
1661657|NCT01524289|3057196|Other|Pre-specified|Difference in Percentages|1.5||||0.218|2-Sided|95.0|-2.2|4.3|||Miettinen and Nurminen||||
1661658|NCT01524289|3057197|Other|Pre-specified|Difference in Percentages|-1.0||||0.157|2-Sided|95.0|-5.4|0.9|||Miettinen and Nurminen||||
1661659|NCT01524289|3057198|Other|Pre-specified|Difference in Percentages|-1.0||||0.157|2-Sided|95.0|-5.4|0.9|||Miettinen and Nurminen||||
1661660|NCT01524289|3057199|Other|Pre-specified|Difference in Percentages|0.5||||0.722|2-Sided|95.0|-4.0|3.5|||Miettinen and Nurminen||||
1661661|NCT01524289|3057200|Other|Pre-specified|Difference in Percentages|0.0|||>|0.999|2-Sided|95.0|-3.7|1.9|||Miettinen and Nurminen||||
1661662|NCT01524289|3057201|Other|Pre-specified|Difference in Percentages|0.5||||0.722|2-Sided|95.0|-4.0|3.5|||Miettinen and Nurminen||||
1661663|NCT01524289|3057202|Other|Pre-specified|Difference in Percentages|0.5||||0.48|2-Sided|95.0|-3.2|2.8|||Miettinen and Nurminen||||
1661664|NCT01524289|3057203|Other|Pre-specified|Difference in Percentages|1.5||||0.696|2-Sided|95.0|-6.8|8.4|||Miettinen and Nurminen||||
1661665|NCT01524289|3057204|Other|Pre-specified|Difference in Percentages|-13.9||||0.011|2-Sided|95.0|-25.0|-3.1|||Miettinen and Nurminen||||
1661666|NCT01524289|3057205|Other|Pre-specified|Difference in Percentages|-7.4||||0.179|2-Sided|95.0|-18.7|3.3|||Miettinen and Nurminen||||
1661667|NCT01524289|3057206|Other|Pre-Specified|Difference in Percentages|-8.4||||0.168|2-Sided|95.0|-20.1|3.5|||Miettinen and Nurminen||||
1661668|NCT01524289|3057207|Other|Pre-specified|Difference in Percentages|1.0|||||2-Sided|95.0|-5.5|6.1|||||||Miettinen and Nurminen
1661669|NCT01524289|3057208|Other|Pre-specified|Difference in Percentages|-0.9|||||2-Sided|95.0|-8.9|5.6|||||||Miettinen & Nurminen
1661670|NCT01524289|3057209|Other|Pre-specified|Difference in Percentages|4.5|||||2-Sided|95.0|-4.8|12.6|||||||Miettinen and Nurminen
1661671|NCT01524289|3057210|Other|Pre-specified|Difference in Percentages|-2.1|||||2-Sided|95.0|-11.5|8.4|||||||Miettinen and Nurminen
1661672|NCT01524289|3057211|Superiority||Difference in Least Squares (LS) Means|-39.7|||<|0.001|2-Sided|95.0|-45.7|-33.7|||Constrained Longitudinal Data Analysis|Between group comparison of percent change from baseline performed using Constrained Longitudinal Data Analysis (cLDA) model.|||
1661673|NCT01523899|3057221|Superiority||||||>|0.05|||||||Chi-squared||||
1661674|NCT01523899|3057222|Superiority||Mean Difference (Final Values)|0.145|||||2-Sided|95.0|||||||||
1661675|NCT01523613|3057267|Superiority|||||||0.1|||||||Fisher Exact||||
1661676|NCT01523613|3057268|Superiority|||||||0.523|||||||Fisher Exact||||
1661677|NCT01523613|3057269|Superiority|||||||0.262|||||||Fisher Exact||||
1661678|NCT01523587|3057270|Superiority or Other||Mean Difference (Final Values)|-2.7|Standard Error of the Mean|1.32||0.0384|2-Sided|95.0|-5.33|-0.15|||Regression, Cox|||The results shown relate to Change in scores over time for: Pain.|
1661679|NCT01523587|3057270|Superiority or Other||Mean Difference (Final Values)|-3.5|Standard Error of the Mean|1.15||0.0024|2-Sided|95.0|-5.75|-1.25|||Regression, Cox|||The results shown relate to Change in scores over time for: Dyspnoea.|
1661680|NCT01523587|3057270|Superiority or Other||Mean Difference (Final Values)|-3.5|Standard Error of the Mean|1.34||0.0091|2-Sided|95.0|-6.15|-0.88|||Regression, Cox|||The results shown relate to Change in scores over time for: Coughing.|
1661681|NCT01523587|3057271|Superiority or Other||Hazard Ratio (HR)|0.99||||0.869|2-Sided|95.0|0.82|1.18||p-value calculated using log rank test stratified by race|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Pain|
1661682|NCT01523587|3057271|Superiority or Other||Hazard Ratio (HR)|0.79||||0.0078|2-Sided|95.0|0.66|0.94||p-value calculated using log rank test stratified by race.|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Dyspnoea|
1661683|NCT01523587|3057271|Superiority or Other||Hazard Ratio (HR)|0.89||||0.2562|2-Sided|95.0|0.72|1.09||p-value calculated using log rank test stratified by race.|Regression, Cox||Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazard model stratified by race.|The results shown relate to Time to Deterioration in Coughing.|
1661684|NCT01523587|3057273|Superiority or Other||Adjusted mean|-1.2|Standard Error of the Mean|1.77||0.5|2-Sided|95.0|-4.67|2.28|||ANCOVA||Mean was adjusted for baseline sum of diameters and race.|The analysis will compare the treatments using analysis of covariance (ANCOVA) for minimum sum of diameters, using baseline sum of diameters as a covariate. The randomization strata will be included as classification factors.|
1661685|NCT01523587|3057274|Superiority or Other||Odds Ratio (OR)|1.56||||0.002|2-Sided|95.0|1.18|2.06|||Regression, Logistic|Odds ratio (Afatinib vs Erlotinib), 95% CI and p−value (two−sided) from logistic regression stratified by race.|||
1661686|NCT01523587|3057275|Superiority or Other||Odds Ratio (OR)|2.06||||0.0551|2-Sided|95.0|0.98|4.32||Odds ratio (Afatinib vs Erlotinib), 95% CI and p−value (two−sided) from logistic regression stratified by race.|Regression, Logistic||||
1661687|NCT01523587|3057276|Superiority or Other||Hazard Ratio (HR)|0.841||||0.0193|2-Sided|95.0|0.727|0.973||P−value from log−rank stratified by Race (two−sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.|Log Rank|||A Cox proportional-hazards model, stratified by race, was used to estimate the hazard ratio and 95% confidence interval (CI) between the two treatment groups.|
1661688|NCT01523587|3057277|Superiority or Other||Hazard Ratio (HR)|0.814||||0.0103|2-Sided|95.0|0.693|0.956||P−value from log−rank stratified by Race (two−sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.|Log Rank|||A Cox proportional hazards model without the randomization stratification variable was used for each subgroup category, along with the corresponding log-rank test.|
1661689|NCT01523392|3057288|Superiority or Other||Mean Difference (Final Values)|-133.4|Standard Error of the Mean|12.77|<|0.001|2-Sided|95.0|-159.7|-107.1|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at end of dosing interval on Day 8|
1661690|NCT01523392|3057288|Superiority or Other||Mean Difference (Final Values)|-118.1|Standard Error of the Mean|12.55|<|0.001|2-Sided|95.0|-143.9|-92.2|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 8 hours on Day 7 after multiple doses|
1661691|NCT01523392|3057288|Superiority or Other||Mean Difference (Final Values)|-135.0|Standard Error of the Mean|12.35|<|0.001|2-Sided|95.0|-160.4|-109.5|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 2 hours on Day 7 after multiple doses|
1661692|NCT01523392|3057289|Superiority or Other||Mean Difference (Final Values)|-165.3|Standard Error of the Mean|15.45|<|0.001|2-Sided|95.0|-197.4|-133.3|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 8 hours after loading dose|
1661693|NCT01523392|3057289|Superiority or Other||Mean Difference (Final Values)|-103.8|Standard Error of the Mean|18.79|<|0.001|2-Sided|95.0|-142.5|-65.0|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel|Analysis at 0.5 hours after loading dose|
1661694|NCT01523392|3057290|Superiority or Other||Mean Difference (Final Values)|-183.6|Standard Error of the Mean|14.68|<|0.001|2-Sided|95.0|-213.9|-153.3||Model contained treatment group, period, and sequence as fixed effects and a random effect for patient within sequence|Mixed Models Analysis||Ticagrelor minus clopidogrel||
1661695|NCT01523366|3057293|Superiority or Other||Mean Difference (Final Values)|-130.6|Standard Error of the Mean|13.41|<|0.001|2-Sided|95.0|-158.0|-103.2|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel.|Analysis at end of dosing interval on Day 8|
1661696|NCT01523366|3057293|Superiority or Other||Mean Difference (Final Values)|-140.2|Standard Error of the Mean|13.84|<|0.001|2-Sided|95.0|-168.4|-111.9|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel.|Analysis at 8 hours on Day 7 after multiple doses|
1661697|NCT01523366|3057293|Superiority or Other||Mean Difference (Final Values)|-150.5|Standard Error of the Mean|12.97|<|0.001|2-Sided|95.0|-176.9|-124.1|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 2 hours on Day 7 after multiple doses|
1661698|NCT01523366|3057294|Superiority or Other||Mean Difference (Final Values)|-168.9|Standard Error of the Mean|17.28|<|0.001|2-Sided|95.0|-204.0|-133.7|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 8 hours after the loading dose|
1661699|NCT01523366|3057294|Superiority or Other||Mean Difference (Final Values)|-135.2|Standard Error of the Mean|18.23|<|0.001|2-Sided|95.0|-172.3|-98.0|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus Clopidogrel|Analysis at 0.5 hours after the loading dose|
1661700|NCT01523366|3057295|Superiority or Other||Mean Difference (Final Values)|-167.2|Standard Error of the Mean|14.6|<|0.001|2-Sided|95.0|-197.0|-137.4|||Mixed Models Analysis|Model contained treatment group, period, and sequence as fixed effects, and a random effect for participant within sequence|Ticagrelor minus clopidogrel||
1661701|NCT01523301|3057302|Superiority or Other||Difference in LS Mean|-1.12|||=|0|2-Sided|95.0|-2.56|0.33||The null hypothesis was assessed with a 2-sided test and not rejected at p≤0.05.|ANCOVA|||The change from Baseline to the end of the Maintenance period in the score of the HAM-D of rotigotine-treated subjects has been compared with those subjects on placebo in the EES. The null hypothesis (H0) was that there was no difference in the change of the HAM-D score between the active treatment and the placebo group. The alternative hypothesis (H1) was that there was a difference in the change of HAM-D score between the rotigotine and the placebo arm.|
1661702|NCT01523275|3057303|Equivalence|0.5 liters per second is clinically significant.||||||0.64|||||||t-test, 2 sided||||
1661703|NCT01523275|3057304|Equivalence|A difference of 6 months to symptom progression is clinically meaningful.||||||0.52|||||||t-test, 2 sided||||
1661704|NCT01523275|3057305|Equivalence|Analysis of 44 subjects (22 in each arm) would provide 90% power to detect a difference in the time interval to reoperation of 6 months between the two treatment arms, at an alpha level of 0.05. This difference of 6 months is clinically meaningful and is smaller than previous case series studies would suggest. However, due to poor patient accrual, the study was closed prior to reaching the desired study size.||||||0.95|||||||t-test, 2 sided||||
1661705|NCT01522755|3057330|Other|t-test|||||<|0.05|||||||t-test, 2 sided||||
1661706|NCT01522755|3057331|Other|t-test|||||<|0.05|||||||t-test, 2 sided||||
1661708|NCT01522443|3057358|Superiority or Other||Hazard Ratio (HR)|0.7||||0.121|2-Sided|95.0|0.44|1.1|||Log Rank|The Log-Rank Test was stratified by baseline Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.|||
1661709|NCT01522443|3057359|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) Test was stratified by baslined Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.|||
1661710|NCT01522443|3057360|Superiority or Other|||||||0.773|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) was stratified by the Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.|||
1661711|NCT01522391|3057369|Other|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Day 21|
1661712|NCT01522391|3057369|Other|||||||0.705|||||||Wilcoxon (Mann-Whitney)|||Day 14|
1661713|NCT01522391|3057369|Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Day 7 morning|
1661714|NCT01522391|3057370|Other|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||Day 21 morning|
1661715|NCT01522391|3057370|Other|||||||0.651|||||||Wilcoxon (Mann-Whitney)|||Day 14 morning|
1661716|NCT01522391|3057370|Other|||||||0.477|||||||Wilcoxon (Mann-Whitney)|||Day 7 morning|
1661717|NCT01522391|3057373|Other|||||||0.495|||||||Cochran-Mantel-Haenszel|||Day 21|
1661718|NCT01522391|3057373|Other|||||||0.946|||||||Cochran-Mantel-Haenszel|||Day 14|
1661719|NCT01522391|3057373|Other|||||||0.375|||||||Cochran-Mantel-Haenszel|||Day 7|
1661720|NCT01522391|3057374|Other|||||||0.962|||||||Cochran-Mantel-Haenszel|||Day 21|
1661721|NCT01522391|3057374|Other|||||||0.975|||||||Cochran-Mantel-Haenszel|||Day 14|
1661722|NCT01522391|3057374|Other|||||||0.378|||||||Cochran-Mantel-Haenszel|||Day 7|
1661723|NCT01522391|3057375|Other|||||||0.086|||||||Cochran-Mantel-Haenszel|||Day 21|
1661724|NCT01522391|3057375|Other|||||||0.82|||||||Cochran-Mantel-Haenszel|||Day 14|
1661725|NCT01522391|3057375|Other|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 7|
1661726|NCT01522391|3057376|Other|||||||0.208|||||||Cochran-Mantel-Haenszel||||
1661727|NCT01522391|3057376|Other|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 14|
1661728|NCT01522391|3057376|Other|||||||0.825|||||||Cochran-Mantel-Haenszel|||Day 7|
1661729|NCT01522391|3057377|Other|||||||0.033|||||||Cochran-Mantel-Haenszel|||Day 21|
1661730|NCT01522391|3057377|Other|||||||0.113|||||||Cochran-Mantel-Haenszel|||Day 14|
1661731|NCT01522391|3057377|Other|||||||0.291|||||||Cochran-Mantel-Haenszel|||Day 7|
1661732|NCT01522391|3057378|Other|||||||0.098|||||||Cochran-Mantel-Haenszel|||Day 21|
1661733|NCT01522391|3057378|Other|||||||0.249|||||||Cochran-Mantel-Haenszel|||Day 14|
1661734|NCT01522391|3057378|Other|||||||0.489|||||||Cochran-Mantel-Haenszel|||Day 7|
1661735|NCT01522391|3057379|Other|||||||0.204|||||||Cochran-Mantel-Haenszel|||Day 21|
1661736|NCT01522391|3057379|Other|||||||0.777|||||||Cochran-Mantel-Haenszel|||Day 14|
1661737|NCT01522391|3057379|Other|||||||0.511|||||||Cochran-Mantel-Haenszel|||Day 7|
1661738|NCT01522391|3057380|Other|||||||0.271|||||||Cochran-Mantel-Haenszel|||Day 21|
1661739|NCT01522391|3057380|Other|||||||0.898|||||||Cochran-Mantel-Haenszel|||Day 14|
1661740|NCT01522391|3057380|Other|||||||0.701|||||||Cochran-Mantel-Haenszel|||Day 7|
1661741|NCT01522391|3057381|Other||least Square Mean Difference|-7.94||||0.642|2-Sided|95.0|-41.82|25.94|||Mixed Models Analysis|||Day 21|
1661742|NCT01522391|3057381|Other||Least Square Mean Difference|15.72||||0.358|2-Sided|95.0|-18.18|49.62|||Mixed Models Analysis|||Day 14|
1661743|NCT01522391|3057381|Other||Least Square Means Difference|0.97||||0.954|2-Sided|95.0|-32.93|34.87|||Mixed Models Analysis|||Day 7|
1661744|NCT01522391|3057382|Other||Least Square Mean Difference|-1.23||||0.941|2-Sided|95.0|-34.42|31.96|||Mixed Models Analysis|||Day 21|
1661745|NCT01522391|3057382|Other||Least Square Mean Difference|20.44||||0.224|2-Sided|95.0|-12.75|53.63|||Mixed Models Analysis|||Day 14|
1661746|NCT01522391|3057382|Other||Least Square Mean Difference|8.04||||0.631|2-Sided|95.0|-25.15|41.24|||Mixed Models Analysis|||Day 7|
1661747|NCT01522391|3057383|Other||Least Square Mean Difference|-18.66||||0.322|2-Sided|95.0|-55.92|18.61|||Mixed Models Analysis|||Day 21|
1661748|NCT01522391|3057383|Other||Least Square Mean Difference|14.62||||0.437|2-Sided|95.0|-22.65|51.88|||Mixed Models Analysis|||Day 14|
1661749|NCT01522391|3057383|Other||Least Square Mean Difference|5.95||||0.748|2-Sided|95.0|-30.84|42.73|||Mixed Models Analysis|||Day 7|
1661750|NCT01522391|3057384|Other||Least Square Mean Difference|-11.64||||0.59|2-Sided|95.0|-54.44|31.16|||Mixed Models Analysis|||Day 21|
1661751|NCT01522391|3057384|Other||Least Square Mean Difference|29.1||||0.18|2-Sided|95.0|-13.71|71.9|||Mixed Models Analysis|||Day 14|
1661752|NCT01522391|3057384|Other||Least Square Mean Difference|20.38||||0.346|2-Sided|95.0|-22.42|63.19|||Mixed Models Analysis|||Day 7|
1661753|NCT01522391|3057385|Other||Ratio between geometric means|0.257||||0.257|2-Sided|95.0|0.024|2.752|||Mixed Models Analysis|||Day 21|
1661754|NCT01522391|3057385|Other||Ratio between geometric means|0.021||||0.002|2-Sided|95.0|0.002|0.227|||Mixed Models Analysis|||Day 14|
1661755|NCT01522391|3057385|Other||Ratio between geometric means|0.202||||0.197|2-Sided|95.0|0.017|2.34|||Mixed Models Analysis|||Day 7|
1661756|NCT01522391|3057386|Other||Ratio between geometric means|0.428||||0.483|2-Sided|95.0|0.039|4.697|||Mixed Models Analysis|||Day 21|
1661757|NCT01522391|3057386|Other||Ratio between geometric means|0.045||||0.012|2-Sided|95.0|0.004|0.491|||Mixed Models Analysis|||Day 14|
1661758|NCT01522391|3057386|Other||Ratio between geometric means|0.242||||0.242|2-Sided|95.0|0.022|2.659|||Mixed Models Analysis|||Day 7|
1661759|NCT01522391|3057387|Other||Ratio between geometric means|0.447||||0.504|2-Sided|95.0|0.041|4.883|||Mixed Models Analysis|||Day 21|
1661760|NCT01522391|3057387|Other||Ratio between geometric means|0.046||||0.013|2-Sided|95.0|0.004|0.512|||Mixed Models Analysis|||Day 14|
1661761|NCT01522391|3057387|Other||Ratio between geometric means|0.961||||0.974|2-Sided|95.0|0.081|11.43|||Mixed Models Analysis|||Day 7|
1661762|NCT01522391|3057388|Other||Ratio between geometric means|0.36||||0.377|2-Sided|95.0|0.036|3.556|||Mixed Models Analysis|||Day 21|
1661764|NCT01522391|3057388|Other||Ratio between geometric means|1.045||||0.97|2-Sided|95.0|0.106|10.32|||Mixed Models Analysis|||Day 7|
1661765|NCT01522391|3057389|Other||Ratio between geometric means|0.271||||0.368|2-Sided|95.0|0.015|4.779|||Mixed Models Analysis|||Day 21|
1661766|NCT01522391|3057389|Other||Ratio between geometric means|0.032||||0.021|2-Sided|95.0|0.002|0.583|||Mixed Models Analysis|||Day 14|
1661767|NCT01522391|3057389|Other||Ratio between geometric means|0.287||||0.403|2-Sided|95.0|0.015|5.55|||Mixed Models Analysis|||Day 7|
1661768|NCT01522391|3057390|Other||Ratio between geometric means|0.484||||0.62|2-Sided|95.0|0.027|8.787|||Mixed Models Analysis|||Day 21|
1661769|NCT01522391|3057390|Other||Ratio between geometric means|0.067||||0.067|2-Sided|95.0|0.004|1.218|||Mixed Models Analysis|||Day 14|
1661770|NCT01522391|3057390|Other||Ratio between geometric means|0.288||||0.395|2-Sided|95.0|0.016|5.221|||Mixed Models Analysis|||Day 7|
1661771|NCT01522391|3057391|Other||Ratio between geometric means|0.428||||0.482|2-Sided|95.0|0.039|4.696|||Mixed Models Analysis|||Day 21|
1661772|NCT01522391|3057391|Other||Ratio between geometric means|0.242||||0.242|2-Sided|95.0|0.022|2.66|||Mixed Models Analysis|||Day 7|
1661773|NCT01522391|3057392|Other||Ratio between geometric means|0.428||||0.482|2-Sided|95.0|0.039|4.696|||Mixed Models Analysis|||Day 21|
1661774|NCT01522391|3057392|Other||Ratio between geometric means|0.242||||0.242|2-Sided|95.0|0.022|2.66|||Mixed Models Analysis|||Day 7|
1661775|NCT01522391|3057393|Other||Ratio between geometric means|0.045||||0.012|2-Sided|95.0|0.004|0.491|||Mixed Models Analysis||||
1661776|NCT01522391|3057394|Other||Ratio between geometric means|0.045||||0.012|2-Sided|95.0|0.004|0.491|||Mixed Models Analysis||||
1661777|NCT01521923|3057447|Superiority or Other||Odds Ratio (OR)|1.889|||=|0|2-Sided|95.0|1.026|3.48|||Regression, Logistic|||In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order. A hierarchical test procedure was applied to protect the Overall significance level for the multiplicity of endpoints. Hypothesis testing was performed in the following predefined order, each at a 2-sided 95 % alpha level|
1661778|NCT01521923|3057447|Superiority or Other||Odds Ratio (OR)|1.719|||=|0|2-Sided|95.0|0.881|3.354|||Regression, Logistic|||In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order beginning with the CZP standard maintenance dosing (200 mg Q2W) + MTX group vs the CZP stopped dosing (PBO) + MTX group. If this analysis was statistically significant at the alpha =0.05 level, then an additional comparison of the CZP reduced frequency dosing (200 mg Q4W) + MTX group vs the CZP stopped dosing + MTX group was performed with testing at the alpha =0.05 level|
1661779|NCT01521845|3057488|Superiority or Other|||||||1|||||||not comparable||||
1661780|NCT01521845|3057489|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1661781|NCT01521845|3057490|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1661782|NCT01521780|3057494|Superiority or Other||Within subject coefficient of variation|0.0555|||||1-Sided|90.0||0.0733|||||||
1661783|NCT01521780|3057495|Superiority or Other||Within subject coefficient of variation|0.0803|||||1-Sided|90.0||0.1163|||||||
1661784|NCT01521559|3057498|Superiority or Other||Mean Difference (Net)|2.6||||0.0833|2-Sided|95.0|-0.3|5.5|||ANCOVA|||Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA >20/200) as fixed factors.|
1661785|NCT01521559|3057499|Superiority or Other||Mean Difference (Net)|-148.6|||<|0.0001|2-Sided|95.0|-179.8|-117.4|||ANCOVA|||Difference was IAI group minus laser group; P-value, Point estimate, and 95% CI, were based on an ANCOVA model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA >20/200) as fixed factors.|
1661786|NCT01521559|3057500|Superiority or Other||Mean Difference (Net)|10.5|||<|0.0001|2-Sided|95.0|7.1|14.0|||ANCOVA|||Difference was IAI group minus laser group. P-value, Point estimate and 95% confidence interval (CI) were based on an analysis of covariance (ANCOVA) model with baseline measurement as covariate and treatment group, region, and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA >20/200) as fixed factors.|
1661787|NCT01521559|3057501|Superiority or Other||Mean Difference (Net)|26.6||||0.0003|2-Sided|95.0|13.0|40.1||P-value was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (Japan vs North America) and baseline Best Corrected Visual Acuity (BCVA ≤20/200 and BCVA >20/200).|Cochran-Mantel-Haenszel||Difference was IAI group minus laser group; Difference and confidence interval were calculated using Mantel-Haenszel weighting scheme adjusted by regions (Japan vs North America) and baseline BCVA (BCVA ≤20/200 and BCVA >20/200).||
1661788|NCT01521507|3057503|Superiority or Other|||||||0.0237||||||Stage 2 Secondary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.|Mixed Models Analysis|||The null and alternative hypotheses for the Stage 2 Secondary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total OSDI score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.|
1661789|NCT01521507|3057504|Superiority or Other|||||||0.0419|||||||Mixed Models Analysis|||Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.|
1661790|NCT01521507|3057504|Superiority or Other|||||||0.0068||||||Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.|t-test, 2 sided|||The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt > µc, where µt and µc are the mean changes in total OSDI scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Secondary Outcome, the minimum sample size was 84 per group with a power of 80% and a one-sided alpha of 0.025.|
1661822|NCT01520363|3057645|Superiority||Mean Difference (Net)|0.409|Standard Deviation|3.5||0.589|2-Sided|95.0|-1.143|1.961|||t-test, 2 sided||||t=0.548; p=0.589
1662014|NCT01519674|3057837|Superiority or Other||Odds Ratio (OR)|1.12||||0.618||95.0|0.73|1.71|||Regression, Logistic||||
1661791|NCT01521507|3057505|Superiority or Other|||||||0.9098|||||||Mixed Models Analysis|Stage 2 Primary Outcome was analyzed with a multivariate mixed model with the subgroup as a fixed effect while controlling for other covariates.||The null and alternative hypotheses for the Stage 2 Primary Outcome was: H0: µi= µj for all i and j where i≠j versus Ha: µi ≠ µj for at least one i and j, where µi is the mean total meibomian gland score at 12 Months for the ith subgroup. The null hypothesis was tested with a two-sided test at alpha=0.05. Since Stage 2 was an observational design, no minimum sample size was calculated for Stage 2.|
1661792|NCT01521507|3057506|Superiority or Other|||||||0.002|||||||Mixed Models Analysis|||Supportive multivariate mixed model was also performed for this outcome controlling for significant demographic and baseline characteristics.|
1661793|NCT01521507|3057506|Superiority or Other||||||<|0.0001||||||Stage 1 primary and secondary outcomes were tested in order under a closed form testing method. Secondary outcome was tested only if primary outcome was statistically significant. If both outcomes were significant, overall study alpha was 0.025.|z-statistic|p-value was based on z-statistic of the sum of weighted average of difference in scores between groups at each site divided by the sum of the weights.||The null and alternative hypotheses are H0: µt ≤ µc vs. Ha: µt > µc, where µt and µc are the mean changes in total meibomian gland scores from Baseline to 3 Months for the LipiFlow (test) and Warm Compress and Lid Hygiene (active control) groups, respectively. For the Stage 1 Primary Outcome, the minimum sample size was 24 subjects per group with a power of 90% and a one-sided alpha of 0.025.|
1661794|NCT01520922|3057569|Superiority or Other||Percentage of participants|74.0|||||2-Sided|95.0|59.67|84.74|||||The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 70 mg/m^2.||
1661795|NCT01520922|3057569|Superiority or Other||Percentage of participants|95.0|||||2-Sided|95.0|84.53|99.44|||||The estimated value represents the percentage of participants with OR (CR+CRi+nPR+PR) while receiving ofatumumab + bendamustine 90 mg/m^2.||
1661796|NCT01520909|3057601|Superiority or Other||Odds Ratio (OR)|25.33|||<|0.001|2-Sided|95.0|8.15|78.73|||Repeated measures model for binary data|Repeated measures model for binary data using Generalized linear mixed model|||
1661797|NCT01520909|3057602|Superiority or Other||Odds Ratio (OR)|17.96|||<|0.001|2-Sided|95.0|2.29|140.93|||Cochran-Mantel-Haenszel|The proportion of participants achieving platelet counts >=50 Gi/L for those participants receiving eltrombopag versus placebo was compared.||Indicated significance at the 5% (two-sided) level of significance|
1661798|NCT01520363|3057631|Superiority||Mean Difference (Net)|0.74|Standard Error of the Mean|0.68||0.28|2-Sided|95.0|-0.66|2.15|||t-test, 2 sided||||
1661799|NCT01520363|3057632|Superiority||Mean Difference (Net)|-0.83|Standard Error of the Mean|0.64||0.21|2-Sided|95.0|-2.17|0.52|||t-test, 2 sided||||
1661800|NCT01520363|3057633|Superiority||Mean Difference (Net)|0.84|Standard Deviation|27.8994||0.909|2-Sided|95.0|-14.6102|16.2902|||t-test, 2 sided|df=14|t=0.117; p=0.909||
1661801|NCT01520363|3057633|Superiority||Mean Difference (Net)|3.8167|Standard Deviation|40.2609||0.693|2-Sided|95.0|-16.2046|23.8379|||t-test, 2 sided|df=17|t=0.402; p=0.693||
1661802|NCT01520363|3057634|Superiority||Mean Difference (Net)|0.7143|Standard Deviation|16.5084||0.874|2-Sided|95.0|-8.8174|10.246|||t-test, 2 sided|df=13|t=0.162; p=0.874||
1661803|NCT01520363|3057634|Superiority||Mean Difference (Net)|3.7474|Standard Deviation|26.711||0.549|2-Sided|95.0|-9.1269|16.6217|||t-test, 2 sided|df=18|t=0.612; p=0.549||
1661804|NCT01520363|3057635|Superiority||Mean Difference (Net)|7.5|Standard Deviation|14.378||0.073|2-Sided|95.0|-0.802|15.802|||t-test, 2 sided|df=13|||t=1.952; p=0.073
1661805|NCT01520363|3057635|Superiority||Mean Difference (Net)|11.765|Standard Deviation|26.276||0.083|2-Sided|95.0|-1.745|25.275|||t-test, 2 sided|df=16|||t=1.846; p=0.083
1661806|NCT01520363|3057636|Superiority||Mean Difference (Net)|2.42857|Standard Deviation|11.21479||0.432|2-Sided|95.0|-4.04665|8.9038|||t-test, 2 sided|df=13|t=0.810; p=0.432||
1661807|NCT01520363|3057636|Superiority||Mean Difference (Net)|3.09412|Standard Deviation|24.06228||0.603|2-Sided|95.0|-9.27756|15.4658|||t-test, 2 sided|df=16|t=0.530; p=0.603||
1661808|NCT01520363|3057637|Superiority||Mean Difference (Net)|4.9917|Standard Deviation|18.0163||0.358|2-Sided|95.0|-6.4553|16.4387|||t-test, 2 sided|df=11|t=0.960; p=0.358||
1661809|NCT01520363|3057637|Superiority||Mean Difference (Net)|8.4615|Standard Deviation|32.8016||0.371|2-Sided|95.0|-11.3603|28.2834|||t-test, 2 sided|df=12|||t=0.903; p=0.371
1661810|NCT01520363|3057638|Superiority||Mean Difference (Net)|-1.03|Standard Error of the Mean|2.97|<|0.73|2-Sided|95.0|-7.02|4.96|||t-test, 2 sided||||
1661811|NCT01520363|3057639|Superiority||Mean Difference (Net)|-3.38|Standard Error of the Mean|4.18||0.42|2-Sided|95.0|-11.8|5.05|||t-test, 2 sided||||
1661812|NCT01520363|3057640|Superiority||Mean Difference (Net)|0.12|Standard Deviation|2.698||0.826|2-Sided|95.0|-0.993|1.233|||t-test, 2 sided|df=24|||t=0.222; p=0.826
1661813|NCT01520363|3057640|Superiority||Mean Difference (Net)|0.136|Standard Deviation|3.06||0.836|2-Sided|95.0|-1.22|1.493|||t-test, 2 sided||||t=0.209; p=0.836
1661814|NCT01520363|3057641|Superiority||Mean Difference (Net)|0.48|Standard Deviation|2.551||0.356|2-Sided|95.0|-0.573|1.533|||t-test, 2 sided|df=24|||t=0.941; p=0.356
1661815|NCT01520363|3057641|Superiority||Mean Difference (Net)|0.091|Standard Deviation|3.504||0.9|2-Sided|95.0|-1.463|1.644|||t-test, 2 sided||||t=0.122; p=0.90
1661816|NCT01520363|3057642|Superiority||Mean Difference (Net)|1.16|Standard Deviation|1.864|<|0.005|2-Sided|95.0|0.391|1.929|||t-test, 2 sided|df=24|||t=3.112; p=0.005
1661817|NCT01520363|3057642|Superiority||Mean Difference (Net)|0.682|Standard Deviation|2.317|<|0.182|2-Sided|95.0|-0.346|1.709|||t-test, 2 sided|df=21|||t=1.380; p=0.182
1661818|NCT01520363|3057643|Superiority||Median Difference (Net)|0.24|Standard Deviation|1.535||0.442|2-Sided|95.0|-0.394|0.874|||t-test, 2 sided|df=24|||t=0.782; p=0.442
1661819|NCT01520363|3057643|Superiority||Median Difference (Net)|0.227|Standard Deviation|1.51||0.488|2-Sided|95.0|-0.442|0.897|||t-test, 2 sided|df=21|||t=0.706; p=0.488
1661820|NCT01520363|3057644|Superiority||Mean Difference (Net)|0.042|Standard Deviation|3.862||0.958|2-Sided|95.0|-1.589|1.672|||t-test, 2 sided||||t=0.053; p=0.958
1661821|NCT01520363|3057644|Superiority||Mean Difference (Net)|-1.429|Standard Deviation|3.203||0.05|2-Sided|95.0|-2.886|0.029|||t-test, 2 sided|df=20|||t=-2.044; p=0.05
1662015|NCT01519674|3057837|Superiority or Other||Odds Ratio (OR)|0.6||||0.022||95.0|0.39|0.93|||Regression, Logistic||||
1661823|NCT01520363|3057645|Superiority||Mean Difference (Net)|-0.227|Standard Deviation|3.116||0.736|2-Sided|95.0|-1.609|1.154|||t-test, 2 sided|df=21|||t=-0.342; p=0.736
1661824|NCT01520363|3057646|Superiority||Mean Difference (Net)|-0.042|Standard Deviation|2.956||0.946|2-Sided|95.0|-1.29|1.206||df=23|t-test, 2 sided||||t=-.069; p=0.946
1661825|NCT01520363|3057646|Superiority||Mean Difference (Final Values)|0.333|Standard Deviation|2.456||0.541|2-Sided|95.0|-0.785|1.451||df=20|t-test, 2 sided|df=20|||t=0.622; p=.541
1661826|NCT01520363|3057647|Superiority||Median Difference (Final Values)|0.043|Standard Error of the Mean|0.67||0.949|2-Sided|95.0|-1.345|1.432|||t-test, 2 sided|df=22|||
1661827|NCT01520363|3057647|Superiority||Mean Difference (Net)|-1.182|Standard Deviation|4.294||0.211|2-Sided|95.0|-3.086|0.722|||t-test, 2 sided|df=21|||t= -1.291; p=.211
1661828|NCT01520324|3057655|Other|The data documented in this trial and the parameters measured were described using classic statistics, i.e. mean, SD, CV(%), median, minimum and maximum values for quantitative variables and frequencies for qualitative variables.||||||||||||||||The number of detected neoplasiae for each patient was listed and summarised by descriptive statistics. Number and percentage of patients with intraepithelial neoplasiae was presented|The data documented in this trial and the parameters measured were described using classic statistics, i.e. mean, SD, CV(%), median, minimum and maximum values for quantitative variables and frequencies for qualitative variables.
1661829|NCT01519960|3057706|Superiority or Other (legacy)|||||||0.096|||||||Fisher's Exact||||
1661830|NCT01519960|3057707|Superiority or Other (legacy)||Odds Ratio (OR)|1.17||||1|2-Sided|95.0|0.25|7.3|||Fisher's Exact||The OR was calculated using Group B as reference.||
1661831|NCT01519960|3057708|Superiority or Other (legacy)|||||||0.0004|||||||Fisher's Exact||||
1661832|NCT01519960|3057709|Superiority or Other (legacy)||Odds Ratio (OR)|21.7|||<|0.0001|2-Sided|95.0|3.33|902.1|||Fisher's Exact||The OR was calculated using Group B as reference.||
1661833|NCT01519960|3057710|Superiority or Other (legacy)||Odds Ratio (OR)|4.24||||0.0019|2-Sided|95.0|1.58|13.23|||Fisher's Exact||The OR was calculated using Group B as reference.||
1661834|NCT01519960|3057711|Superiority or Other (legacy)||Odds Ratio (OR)|0.82||||0.6684|2-Sided|95.0|0.33|2.11|||Fisher's Exact||The OR was calculated using Group B as reference.||
1661835|NCT01519960|3057712|Superiority or Other (legacy)|||||||0.0163|||||||Fisher's Exact||||
1661836|NCT01519960|3057713|Superiority or Other (legacy)|||||||0.096|||||||Fisher's Exact||||
1661837|NCT01519960|3057714|Superiority or Other (legacy)||Odds Ratio (OR)|1.53||||0.7515|2-Sided|95.0|0.36|9.19|||Fisher's Exact||The OR was calculated using Group B as reference.||
1661838|NCT01519960|3057715|Superiority or Other (legacy)||Odds Ratio (OR)|1.35||||1|2-Sided|95.0|0.3|8.23|||Fisher's Exact||The OR was calculated using Group B as reference.||
1661839|NCT01519960|3057716|Superiority or Other (legacy)||Odds Ratio (OR)|12.1||||0.0021|2-Sided|95.0|1.8|511.5|||Fisher's Exact||The OR was calculated using Group B as reference.||
1661840|NCT01519960|3057717|Superiority or Other (legacy)||Odds Ratio (OR)|7.08||||0.0025|2-Sided|95.0|1.61|64.02|||Fisher's Exact||The OR was calculated using Group B as reference.||
1661841|NCT01519960|3057718|Superiority or Other (legacy)||Odds Ratio (OR)|9.92||||0.0069|2-Sided|95.0|1.45|422.7|||Fisher's Exact||The OR was calculated using Group B as reference.||
1661842|NCT01519960|3057719|Superiority or Other (legacy)||Odds Ratio (OR)|19.74|||<|0.0001|2-Sided|95.0|3.02|822.2|||Fisher's Exact||The OR was calculated using Group B as reference.||
1661843|NCT01519960|3057720|Superiority or Other (legacy)||Odds Ratio (OR)|12.18|||<|0.0001|2-Sided|95.0|2.85|108.3|||Fisher's Exact||The OR was calculated using Group B as reference.||
1661844|NCT01519960|3057721|Superiority or Other (legacy)||Odds Ratio (OR)|7.78|||<|0.0001|2-Sided|95.0|2.91|24.05|||Fisher's Exact||The OR was calculated using Group B as reference.||
1661845|NCT01519960|3057722|Superiority or Other (legacy)|||||||0.03|||||||Fisher's Exact||||
1661846|NCT01519960|3057723|Superiority or Other (legacy)|||||||0.0528|||||||Fisher's Exact||||
1661847|NCT01519960|3057724|Superiority or Other (legacy)||Odds Ratio (OR)|5.43||||0.0038|2-Sided|95.0|1.52|29.32|||Fisher's Exact||The OR was calculated using Group B as reference.||
1661848|NCT01519960|3057725|Superiority or Other (legacy)|||||||0.3732|||||||Breslow-Day||||
1661849|NCT01519960|3057725|Superiority or Other (legacy)||Odds Ratio (OR)|5.43||||0.0043|2-Sided|95.0|1.54|19.2|||Cochran-Mantel-Haenszel||The OR was calculated using Group B as reference.|Analysis stratified by hepatitis B virus (HBV) genotype A versus non-A genotypes and alanine aminotransferase (ALT) less than (<) 5 times (×) upper limit of normal (ULN) versus greater than or equal (≥) 5 × ULN at Baseline.|
1661850|NCT01519817|3057755|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.3008||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 4.|Wilcoxon test||||
1661851|NCT01519817|3057755|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.2402||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 3.|Wilcoxon test||||
1661852|NCT01519817|3057755|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.875||||||The reported p-value is representative of the changes in levels of sCD40L cytokines at dose level 1.|Wilcoxon test||||
1661853|NCT01519817|3057755|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.0621||||||The reported p-value is representative of the changes in levels of all sCD40L cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661854|NCT01519817|3057756|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.3008||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 4.|Wilcoxon test||||
1661855|NCT01519817|3057756|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.6772||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 3.|Wilcoxon test||||
1661856|NCT01519817|3057756|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.625||||||The reported p-value is representative of the changes in levels of ratio sCD27:sCD40L cytokines at dose level 1.|Wilcoxon test||||
1661857|NCT01519817|3057756|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.1004||||||The reported p-value is representative of the changes in levels of all ratio sCD27:sCD40AL cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661858|NCT01519817|3057757|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.0742||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 4.|Wilcoxon test||||
1661859|NCT01519817|3057757|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.2036||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 3.|Wilcoxon test||||
1661860|NCT01519817|3057757|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.375||||||The reported p-value is representative of the changes in levels of sCD27 cytokines at dose level 1.|Wilcoxon test||||
1661861|NCT01519817|3057757|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.2901||||||The reported p-value is representative of the changes in levels of all sCD27 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661862|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.6523||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 4.|Wilcoxon test||||
1661863|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.9658||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 3.|Wilcoxon test||||
1661864|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.875||||||The reported p-value is representative of the changes in levels of TNF cytokines at dose level 1.|Wilcoxon test||||
1661865|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of all TNF cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661866|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.8203||||||The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 4.|Wilcoxon test||||
1661867|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.791||||||The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 3.|Wilcoxon test||||
1661868|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.625|||||||Wilcoxon test|The reported p-value is representative of the changes in levels of IL-8 cytokines at dose level 1.|||
1661869|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.9906||||||The reported p-value is representative of the changes in levels of all IL-8 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661870|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 4.|Wilcoxon test||||
1661871|NCT01519817|3057758|Non-Inferiority|The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 3.|||||>|0.4316|||||||Wilcoxon test|||Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|
1661872|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.875||||||The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1.|Wilcoxon test||||
1661873|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.4525||||||The reported p-value is representative of the changes in levels of all IL-6 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test|The reported p-value is representative of the changes in levels of IL-6 cytokines at dose level 1.|||
1661874|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.75||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 4.|Wilcoxon test||||
1661875|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 3.|Wilcoxon test||||
1661876|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL-2 cytokines at dose level 1.|Wilcoxon test||||
1661877|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.4375||||||The reported p-value is representative of the changes in levels of all IL-2 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661878|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 4.|Wilcoxon test||||
1661879|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.5||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 3.|Wilcoxon test||||
1661880|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL1b cytokines at dose level 1.|Wilcoxon test||||
1661881|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.6846||||||The reported p-value is representative of the changes in levels of all IL1b cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661882|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.5||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 14|Wilcoxon test||||
1661883|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 3.|Wilcoxon test||||
1661884|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL12p70 cytokines at dose level 1.|Wilcoxon test||||
1661885|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.5625||||||The reported p-value is representative of the changes in levels of all IL12p70 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661886|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.8203|||||||Wilcoxon test|The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 4.|||
1661887|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.748||||||The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 3.|Wilcoxon test||||
1661888|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of IL10 cytokines at dose level 1.|Wilcoxon||||
1661889|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.4347||||||The reported p-value is representative of the changes in levels of all IL10 cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661890|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.7109||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 4.|Wilcoxon||||
1661891|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.7334||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 3.|Wilcoxon test||||
1661892|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.4808||||||The reported p-value is representative of the changes in levels of all IFNg cytokines at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661893|NCT01519817|3057758|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.375||||||The reported p-value is representative of the changes in levels of IFNg cytokines at dose level 1.|Wilcoxon test||||
1661894|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.3||||||The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 4.|Wilcoxon test||||
1661895|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.64||||||The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 3.|Wilcoxon test||||
1661896|NCT01519817|3057759|Non-Inferiority|The reported p-value is representative of the changes in levels of CD8 naive cells at dose level 1.||||||0.63|||||||Wilcoxon test||||
1661897|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.8314||||||The reported p-value is representative of the changes in levels of all CD8 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661898|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.||||||0.36||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 4.|Wilcoxon test||||
1661899|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.999||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 3.|Wilcoxon test||||
1661900|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.63||||||The reported p-value is representative of the changes in levels of CD8 EMRA cells at dose level 1.|Wilcoxon test||||
1661901|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.6295||||||The reported p-value is representative of the changes in levels of all CD8 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1662897|NCT01499576|3059781|Superiority or Other||Kappa index of agreement|0.808|||<|0.01|2-Sided||||||Kappa index of agreement||||
1661902|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.2||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 4.|Wilcoxon test||||
1661903|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.74||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 3.|Wilcoxon test||||
1661904|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.88||||||The reported p-value is representative of the changes in levels of CD8 CM cells at dose level 1.|Wilcoxon test||||
1661905|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.6577||||||The reported p-value is representative of the changes in levels of all CD8 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661906|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.73||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 4.|Wilcoxon test||||
1661907|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.68||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 3.|Wilcoxon test||||
1661908|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.63||||||The reported p-value is representative of the changes in levels of CD8 EM cells at dose level 1.|Wilcoxon test||||
1661909|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.5076||||||The reported p-value is representative of the changes in levels of all CD8 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661910|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.65||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 4.|Wilcoxon test||||
1661911|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.0215||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 3.|Wilcoxon test||||
1661912|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.88||||||The reported p-value is representative of the changes in levels of CD4 naive cells at dose level 1.|Wilcoxon test||||
1661913|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.3386||||||The reported p-value is representative of the changes in levels of all CD4 naive cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661914|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 4.|Wilcoxon test||||
1661915|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.13||||||The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 3.|Wilcoxon test||||
1661916|NCT01519817|3057759|Non-Inferiority|The reported p-value is representative of the changes in levels of CD4 EMRA cells at dose level 1.|||||>|0.63|||||||Wilcoxon test||||
1661917|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.3741||||||The reported p-value is representative of the changes in levels of all CD4 EMRA cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661918|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.13||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 4.|Wilcoxon test||||
1661919|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.06||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 3.|Wilcoxon test||||
1661920|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.13||||||The reported p-value is representative of the changes in levels of CD4 CM cells at dose level 1.|Wilcoxon test||||
1661921|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.7144||||||The reported p-value is representative of the changes in levels of all CD4 CM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661922|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.1||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 4.|Wilcoxon test||||
1661923|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.22||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 3.|Wilcoxon test||||
1661924|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.38||||||The reported p-value is representative of the changes in levels of CD4 EM cells at dose level 1.|Wilcoxon test||||
1661948|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.63||||||The reported p-value is representative of the changes in levels of NK cells at dose level 1.|Wilcoxon test||||
1661925|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.0076||||||The reported p-value is representative of the changes in levels of all CD4 EM cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661926|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.36||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 4.|Wilcoxon test||||
1661927|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.45||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 1.|Wilcoxon test||||
1661928|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.88||||||The reported p-value is representative of the changes in levels of Treg cells at dose level 1.|Wilcoxon test||||
1661929|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.2666||||||The reported p-value is representative of the changes in levels of all Treg cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661930|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.91||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 4.|Wilcoxon test||||
1661931|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.38||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 3.|Wilcoxon test||||
1661932|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of MDSC cells at dose level 1.|Wilcoxon test||||
1661933|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.7114||||||The reported p-value is representative of the changes in levels of all MDSC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661934|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.13||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 4.|Wilcoxon test||||
1661935|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.55||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 3.|Wilcoxon test||||
1661936|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.63||||||The reported p-value is representative of the changes in levels of pDC cells at dose level 1.|Wilcoxon test||||
1661937|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.0457||||||The reported p-value is representative of the changes in levels of all pDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661938|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.16||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 4.|Wilcoxon test||||
1661939|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.21||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 3.|Wilcoxon test||||
1661940|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.38||||||The reported p-value is representative of the changes in levels of cDC cells at dose level 1.|Wilcoxon test||||
1661941|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.0654||||||The reported p-value is representative of the changes in levels of all cDC cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661942|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.07||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 4.|Wilcoxon test||||
1661943|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.41||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 3.|Wilcoxon test||||
1661944|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.63||||||The reported p-value is representative of the changes in levels of NKT cells at dose level 1.|Wilcoxon test||||
1661945|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.0127||||||The reported p-value is representative of the changes in levels of all NKT cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661946|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.13||||||The reported p-value is representative of the changes in levels of NK cells at dose level 4.|Wilcoxon test||||
1661947|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.74||||||The reported p-value is representative of the changes in levels of NK cells at dose level 3.|Wilcoxon test||||
1662013|NCT01519674|3057837|Superiority or Other||Odds Ratio (OR)|1.85||||0.005||95.0|1.2|2.85|||Regression, Logistic||||
1661949|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.0698||||||The reported p-value is representative of the changes in levels of all NK cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661950|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.65||||||The reported p-value is representative of the changes in levels of B cells at dose level 4.|Wilcoxon test||||
1661951|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.13||||||The reported p-value is representative of the changes in levels of B cells at dose level 3.|Wilcoxon test||||
1661952|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.9999||||||The reported p-value is representative of the changes in levels of B cells at dose level 1.|Wilcoxon test|The reported p-value is representative of the changes in levels of B cells at dose level 1.|||
1661953|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.3052||||||The reported p-value is representative of the changes in levels of all B cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661954|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.57||||||The reported p-value is representative of the changes in levels of CD8 cells at dose level 4.|Wilcoxon test||||
1661955|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.84||||||The reported p-value is representative of the changes in levels of CD8 cells at dose level 3.|Wilcoxon test||||
1661956|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.88||||||The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661957|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.8665||||||The reported p-value is representative of the changes in levels of all CD8 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661958|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.16||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 4.|Wilcoxon test||||
1661959|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.5||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 3.|Wilcoxon test||||
1661960|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.25||||||The reported p-value is representative of the changes in levels of CD4 cells at dose level 1.|Wilcoxon test||||
1661961|NCT01519817|3057759|Non-Inferiority|Significance was met if the unadjusted p-value was <0.05 and >1/2 of patients had a serum level change of >25%.|||||>|0.5221||||||The reported p-value is representative of the changes in levels of all CD4 cells at dose levels 1, 3, and 4. We could not do dose level 2 as we only had data on 2 patients and need an n>2 to do paired analyses.|Wilcoxon test||||
1661962|NCT01519791|3057773|Superiority or Other||Difference in Least Squares (LS) Means|-0.177|Standard Error of the Mean|0.049|<|0.001|2-Sided|95.0|-0.273|-0.082|||ANCOVA||The CfB in HAQ-DI at Week 52 was analyzed using an ANCOVA model with terms for treatment, region, and time since Rheumatoid Arthritis (RA) diagnosis at Baseline (≤4 months or >4 months) as factors and Baseline value as a covariate.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~Primary: sustained DAS28(ESR) remission at Week 52~Key secondary: sustained DAS28(ESR) LDA at Week 52~ACR50 response at Week 52 in relation to Baseline~Change from Baseline in HAQ-DI at Week 52~Change from Baseline in mTSS at Week 52"|
1661963|NCT01519791|3057785|Superiority or Other||Odds Ratio (OR)|1.446|||=|0|2-Sided|95.0|1.052|1.989|||Regression, Logistic||The Odds ratio was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~Primary: sustained DAS28(ESR) remission at Week 52~Key secondary: sustained DAS28(ESR) LDA at Week 52~ACR50 response at Week 52 in relation to Baseline~Change from Baseline in HAQ-DI at Week 52~Change from Baseline in mTSS at Week 52"|
1661964|NCT01519791|3057790|Superiority or Other||Hodges-Lehmann point estimate of shift|-0.978|||<|0.001|2-Sided|95.0|-1.005|-0.5|||ANCOVA on ranks||"ANCOVA model on the ranks with the terms for treatment, region, and time since RA diagnosis at Baseline (≤4 months or >4 months) as factors and rank Baseline value as a covariate.~Confidence Interval is an asymptotic Moses CI."|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~Primary: sustained DAS28(ESR) remission at Week 52~Key secondary: sustained DAS28(ESR) LDA at Week 52~ACR50 response at Week 52 in relation to Baseline~Change from Baseline in HAQ-DI at Week 52~Change from Baseline in mTSS at Week 52"|
1661965|NCT01519791|3057791|Superiority or Other||Odds Ratio (OR)|1.957|||<|0.001|2-Sided|95.0|1.384|2.767|||Regression, Logistic||The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~Primary: sustained DAS28(ESR) remission at Week 52~Key secondary: sustained DAS28(ESR) LDA at Week 52~ACR50 response at Week 52 in relation to Baseline~Change from Baseline in HAQ-DI at Week 52~Change from Baseline in mTSS at Week 52"|
1662898|NCT01499576|3059782|Superiority or Other||percent agreement|89.2|||||2-Sided||||||||||
1661966|NCT01519791|3057792|Superiority or Other||Odds Ratio (OR)|2.283|||<|0.001|2-Sided|95.0|1.503|3.468|||Regression, Logistic||The Odds ratio measuring the treatment effect was estimated from a logistic regression model including terms for treatment, region and stratification factor. Nonresponder imputation (NRI) was used.|"In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in the following hierarchical order (each at a 2-sided 95 % alpha level):~Primary: sustained DAS28(ESR) remission at Week 52~Key secondary: sustained DAS28(ESR) LDA at Week 52~ACR50 response at Week 52 in relation to Baseline~Change from Baseline in HAQ-DI at Week 52~Change from Baseline in mTSS at Week 52"|
1661967|NCT01519765|3057794|Superiority or Other|||||||0.2868||||||This is the overall p value of all rows.|Chi-squared||||
1661968|NCT01519765|3057795|Superiority or Other|||||||0.538||||||Patient satisfaction|Kruskal-Wallis|||Labor satisfaction|
1661969|NCT01519765|3057795|Superiority or Other|||||||0.1223|||||||Kruskal-Wallis|||Patient concern|
1661970|NCT01519765|3057795|Superiority or Other|||||||0.1505|||||||Kruskal-Wallis|||Effectiveness|
1661971|NCT01519765|3057795|Superiority or Other|||||||0.8062|||||||Kruskal-Wallis|||Score for Nausea and vomiting|
1661972|NCT01519765|3057796|Superiority or Other|||||||0.579|||||||Kruskal-Wallis||||
1661973|NCT01519765|3057797|Superiority or Other|||||||0.741|||||||Fisher Exact||||
1661974|NCT01519765|3057798|Superiority or Other|||||||1|||||||Fisher Exact||||
1661975|NCT01519765|3057799|Superiority or Other|||||||0.5118|||||||Fisher Exact||||
1661976|NCT01519765|3057800|Superiority or Other|||||||0.7906|||||||Fisher Exact||||
1661977|NCT01519765|3057801|Superiority or Other|||||||0.6244|||||||Fisher Exact||||
1661978|NCT01519765|3057802|Superiority or Other|||||||0.751|||||||Fisher Exact||||
1661979|NCT01519765|3057803|Superiority or Other|||||||0.797|||||||Fisher Exact||||
1661980|NCT01519765|3057804|Superiority or Other|||||||0.8043|||||||Fisher Exact||||
1661981|NCT01519765|3057805|Superiority or Other|||||||0.1054|||||||Fisher Exact||||
1661982|NCT01519765|3057806|Superiority or Other|||||||1|||||||Fisher Exact||||
1661983|NCT01519765|3057807|Superiority or Other|||||||0.2417|||||||Fisher Exact||||
1661984|NCT01519765|3057808|Superiority or Other|||||||0.093|||||||Kruskal-Wallis||||
1661985|NCT01519765|3057809|Superiority or Other|||||||0.4469|||||||Fisher Exact||||
1661986|NCT01519765|3057810|Superiority or Other|||||||0.4469|||||||Fisher Exact||||
1661987|NCT01519765|3057811|Superiority or Other|||||||0.1141|||||||Kruskal-Wallis||||
1661988|NCT01519765|3057812|Superiority or Other|||||||0.0623|||||||Kruskal-Wallis||||
1661989|NCT01519765|3057813|Superiority or Other|||||||0.018|||||||t-test, 2 sided||||
1661990|NCT01519765|3057814|Superiority or Other|||||||0.1611|||||||Fisher Exact|||A consecutive sample will be used as women are recruited. Based on an 80% power and an alpha of 0.05, a sample size of 103 subjects in each arm is required to detect a 20% difference between deliveries within 24hrs between the two treatment arms. An effect size of 20% was selected as this is thought to be a clinically significant difference. This is based on the Wing study showing 50% delivery within 24 hrs with vaginal misoprostol.|
1661991|NCT01519700|3057827|Non-Inferiority or Equivalence|Non-inferiority limit: -1 day Power: 90% Confidence level: 97.5% Randomization ratio: 1:1 (EP2006:Neupogen)|Mean Difference (Net)|0.04|||||1-Sided|97.5|-0.26||||||The one-sided 97.5% Confidence Interval: [-0.26, ∞).||
1661992|NCT01519674|3057828|Superiority or Other||Estimated treatment difference|-0.28||||0.809||95.0|-2.52|1.97|||Regression, Linear||||
1661993|NCT01519674|3057828|Superiority or Other||Estimated treatment difference|0.02||||0.989||95.0|-2.26|2.29|||Regression, Linear||||
1661994|NCT01519674|3057828|Superiority or Other||Estimated treatment difference|0.29||||0.8||95.0|-1.97|2.56|||Regression, Linear||||
1661995|NCT01519674|3057831|Superiority or Other||Estimated treatment difference|-0.22||||0.213||95.0|-0.56|0.13|||Regression, Linear||||
1661996|NCT01519674|3057831|Superiority or Other||Estimated treatment difference|0.09||||0.613||95.0|-0.26|0.43|||Regression, Linear||||
1661997|NCT01519674|3057831|Superiority or Other||Estimated treatment difference|0.31||||0.08||95.0|-0.04|0.65|||Regression, Linear||||
1661998|NCT01519674|3057832|Superiority or Other||Estimated treatment difference|0.84||||0.004||95.0|0.27|1.41|||Regression, Linear||||
1661999|NCT01519674|3057832|Superiority or Other||Estimated treatment difference|0.72||||0.015||95.0|0.14|1.3|||Regression, Linear||||
1662000|NCT01519674|3057832|Superiority or Other||Estimated treatment difference|-0.12||||0.674||95.0|-0.7|0.45|||Regression, Linear||||
1662001|NCT01519674|3057833|Superiority or Other||Estimated treatment difference|-0.33||||0.275||95.0|-0.92|0.26|||Regression, Linear||||
1662002|NCT01519674|3057833|Superiority or Other||Estimated treatment difference|0.52||||0.085||95.0|-0.07|1.12|||Regression, Linear||||
1662003|NCT01519674|3057833|Superiority or Other||Estimated treatment difference|0.85||||0.005||95.0|0.26|1.45|||Regression, Linear||||
1662004|NCT01519674|3057834|Superiority or Other||Estimated treatment difference|-1.16|||<|0.001||95.0|-1.69|-0.64|||Regression, Linear||||
1662005|NCT01519674|3057834|Superiority or Other||Estimated treatment difference|-0.88|||<|0.001||95.0|-1.41|-0.35|||Regression, Linear||||
1662006|NCT01519674|3057834|Superiority or Other||Estimated treatment difference|0.28|||<|0.291||95.0|-0.24|0.81|||Regression, Linear||||
1662007|NCT01519674|3057835|Superiority or Other||Estimated treatment difference|-0.07||||0.708||95.0|-0.46|0.31|||Regression, Linear||||
1662008|NCT01519674|3057835|Superiority or Other||Estimated treatment difference|0.05||||0.788||95.0|-0.34|0.45|||Regression, Linear||||
1662009|NCT01519674|3057835|Superiority or Other||Estimated treatment difference|0.13||||0.52||95.0|-0.26|0.52|||Regression, Linear||||
1662010|NCT01519674|3057836|Superiority or Other||Odds Ratio (OR)|2.2|||<|0.001||95.0|1.39|3.47|||Regression, Logistic||||
1662011|NCT01519674|3057836|Superiority or Other||Odds Ratio (OR)|1.29|||<|0.286||95.0|0.81|2.07|||Regression, Logistic||||
1662012|NCT01519674|3057836|Superiority or Other||Odds Ratio (OR)|0.59|||<|0.02||95.0|0.38|0.92|||Regression, Logistic||||
1662016|NCT01519674|3057838|Superiority or Other||Estimated treatment difference|-0.36|||<|0.001||95.0|-0.54|-0.17|||Regression, Linear|||The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).|
1662017|NCT01519674|3057838|Superiority or Other||Estimated treatment difference|-0.11|||<|0.231||95.0|-0.3|0.07|||Regression, Linear|||The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by: H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Sita+Met and OD+Sita+Met).|
1662018|NCT01519674|3057838|Superiority or Other||Estimated treatment difference|0.24|||<|0.011||95.0|0.06|0.43||No corrections for multiplicity were performed.|Regression, Linear|||"The null-hypothesis (H0) was tested against the alternative hypothesis (HA) in each of the comparisons as given by:~H0: D = 0% against HA: D ≠ 0% D being the mean treatment difference for change from baseline in HbA1c after 24 weeks of treatment between the two treatment group comparisons (BID+Met and BID+Sita+Met)."|
1662019|NCT01519648|3057851|Superiority or Other||Odds Ratio (OR)|1.872|Standard Error of the Mean|0.237||0.007|2-Sided|95.0|1.178|2.977|||Chi-squared||||
1662020|NCT01519466|3057865|Superiority or Other||Mean Difference (Final Values)|4.36|Standard Deviation|6.53||0.0007|2-Sided|95.0|2.01|6.71|||t-test, 2 sided|||Treatment Satisfaction|
1662021|NCT01519466|3057865|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Deviation|1.03||0.096|2-Sided|95.0|-0.68|0.06|||t-test, 2 sided|||Hypoglycaemia, glucose below 3.9mmol/l (70mg/dL)|
1662022|NCT01519466|3057865|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Deviation|1.26||0.5798|2-Sided|95.0|-0.33|0.58|||t-test, 2 sided|||Hyperglycaemia, glucose above 10mmol/l (180mg/dL)|
1662023|NCT01519466|3057866|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Deviation|0.51|||||||||||||
1662024|NCT01519466|3057866|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Deviation|0.49||0.3251|2-Sided|95.0|-0.27|0.09|||t-test, 2 sided||||
1662025|NCT01519466|3057867|Superiority or Other||Mean Difference (Final Values)|-1.17|Standard Deviation|2.97|||||||||||||
1662026|NCT01519466|3057867|Superiority or Other||Mean Difference (Final Values)|-0.71|Standard Deviation|2.32||0.0926|2-Sided|95.0|-1.55|0.12|||t-test, 2 sided||||
1662027|NCT01519414|3057879|Other|||||||0.02|||||||Log Rank||||
1662028|NCT01519271|3057891|Superiority||Cohen's D|0.35|||||2-Sided||||||||||
1662029|NCT01519245|3057893|Superiority or Other|||||||0.093|||||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of secondary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.|
1662030|NCT01519245|3057894|Superiority or Other|||||||0.1876|||||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of secondary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.|
1662031|NCT01519245|3057896|Superiority or Other|||||||0.0493|||||||t-test, 2 sided|||Intention to Treat principles of data analysis were applied. The two-sided T-test (95% confidence interval) was used for statistical calculation of primary outcomes. The null hypothesis was that no difference in chest tube losses would be found between the topical tranexamic acid and placebo groups in low-risk cardiac patients undergoing CABG.|
1662032|NCT01518946|3057956|Superiority or Other||Mean Difference (Final Values)|521.0||||0.0131|2-Sided|95.0|124.2|917.7|||ANOVA||||
1662033|NCT01518322|3057963|Superiority or Other||Kappa Statistics|0.049|||||2-Sided|95.0|-0.0895|0.1875||||||Kappa statistics were used to determine the level of agreement between FeNO measurements and asthma diagnosis using the a dichotomous schemes a measurement greater than 35 ppb for children under the age of 12 years or greater than 50 ppb for subjects at least 12 years of age was considered high.|
1662034|NCT01517412|3058027|Superiority or Other||LS Mean Difference|0.09|Standard Error of the Mean|0.079||0.2664|2-Sided|||||Threshold for significance at 0.05 level.|ANCOVA||Lixisenatide Main Meal vs Lixisenatide Breakfast|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate. A step-down procedure was used to control the type I error. The superiority was assessed by comparing the p-value at significance level = 0.05.|
1662035|NCT01517412|3058027|Non-Inferiority or Equivalence|A step-down procedure was used to control the type I error: non-inferiority of lixisenatide prior to the main meal of the day versus lixisenatide prior to breakfast was tested first. If non-inferiority was established, then a test of superiority of lixisenatide prior to the main meal of the day over lixisenatide prior to breakfast was to be performed. The non-inferiority was assessed using upper bound of 2-sided 95% CI at a level of ≤0.4%.|Least square (LS) mean difference|0.09|Standard Error of the Mean|0.079|||2-Sided|95.0|-0.067|0.242|||||Lixisenatide Main Meal vs Lixisenatide Breakfast|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (<8.0%, ≥8.0%), randomization strata of main meal of the day and country as fixed effects and baseline HbA1c value as a covariate.|
1662036|NCT01517373|3058029|Superiority or Other||LS Mean Difference|2.62|Standard Error of the Mean|0.39|<|0.0001|2-Sided|80.0|2.12|3.12||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662037|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.86|Standard Error of the Mean|0.387|<|0.0263|2-Sided|80.0|0.37|1.36||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662428|NCT01509677|3058811|Superiority or Other (legacy)||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.086||0.9989|2-Sided|95.0|-0.17|0.17|||ANCOVA|||2-sided 5% test|
1662038|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.49|Standard Error of the Mean|0.392|<|0.2132|2-Sided|80.0|-0.01|0.99||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662039|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.96|Standard Error of the Mean|0.394|<|0.0158|2-Sided|80.0|0.45|1.46||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662040|NCT01517373|3058029|Superiority or Other||LS Mean Difference|2.68|Standard Error of the Mean|0.37|<|0.0001|2-Sided|80.0|2.2|3.15||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662041|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.92|Standard Error of the Mean|0.368|<|0.0132|2-Sided|80.0|0.45|1.39||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662042|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.53|Standard Error of the Mean|0.373|<|0.1557|2-Sided|80.0|0.05|1.01||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662043|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.8|Standard Error of the Mean|0.374|<|0.0335|2-Sided|80.0|0.32|1.28||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662044|NCT01517373|3058029|Superiority or Other||LS Mean Difference|1.63|Standard Error of the Mean|0.31|<|0.0001|2-Sided|80.0|1.23|2.02||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662045|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.69|Standard Error of the Mean|0.308|<|0.026|2-Sided|80.0|0.29|1.08||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662046|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.78|Standard Error of the Mean|0.314|<|0.0133|2-Sided|80.0|0.38|1.19||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662047|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.58|Standard Error of the Mean|0.314|<|0.0667|2-Sided|80.0|0.17|0.98||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662048|NCT01517373|3058029|Superiority or Other||LS Mean Difference|1.09|Standard Error of the Mean|0.263|<|0.0001|2-Sided|80.0|0.76|1.43||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662049|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.28|Standard Error of the Mean|0.261|<|0.2774|2-Sided|80.0|-0.05|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662050|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.32|Standard Error of the Mean|0.265|<|0.2221|2-Sided|80.0|-0.02|0.67||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662051|NCT01517373|3058029|Superiority or Other||LS Mean Difference|-0.01|Standard Error of the Mean|0.266|<|0.9689|2-Sided|80.0|-0.35|0.33||P-value was 2-sided.|t-test, 2 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662052|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.93|Standard Error of the Mean|0.231|<|0.0001|2-Sided|80.0|0.63|1.22||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662053|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.31|Standard Error of the Mean|0.231|<|0.1835|2-Sided|80.0|0.01|0.6||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662054|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.51|Standard Error of the Mean|0.235|<|0.0319|2-Sided|80.0|0.2|0.81||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662148|NCT01516008|3058134|Superiority or Other||Mean Difference (Net)|34.71|||<|0.001|2-Sided|95.0|23.2|46.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.|24 hours|
1662055|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.25|Standard Error of the Mean|0.235|<|0.2819|2-Sided|80.0|-0.05|0.55||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662056|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.39|Standard Error of the Mean|0.194|<|0.0454|2-Sided|80.0|0.14|0.64||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662057|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.37|Standard Error of the Mean|0.193|<|0.0585|2-Sided|80.0|0.12|0.61||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662058|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.37|Standard Error of the Mean|0.195|<|0.0555|2-Sided|80.0|0.12|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662059|NCT01517373|3058029|Superiority or Other||LS Mean Difference|0.33|Standard Error of the Mean|0.196|<|0.0898|2-Sided|80.0|0.08|0.59||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, duration of type 2 diabetes mellitus (T2DM), time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662060|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-25.93|Standard Error of the Mean|6.233|<|0.0001|2-Sided|80.0|-33.93|-17.92||P-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662061|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-14.87|Standard Error of the Mean|6.232|<|0.0089|2-Sided|80.0|-22.88|-6.86|||t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662062|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-10.99|Standard Error of the Mean|6.287|<|0.0409|2-Sided|80.0|-19.07|-2.91|||t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662063|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-8.03|Standard Error of the Mean|6.281|<|0.1012|2-Sided|80.0|-16.1|0.04||P-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662064|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-27.0|Standard Error of the Mean|5.48|<|0.0001|2-Sided|80.0|-34.04|-19.96||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662065|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-12.44|Standard Error of the Mean|5.469|<|0.0118|2-Sided|80.0|-19.47|-5.41||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662066|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-10.54|Standard Error of the Mean|5.566|<|0.0297|2-Sided|80.0|-17.69|-3.38||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662067|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-5.18|Standard Error of the Mean|5.534|<|0.1748|2-Sided|80.0|-12.29|1.93||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662068|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-19.69|Standard Error of the Mean|5.624|<|0.0003|2-Sided|80.0|-26.91|-12.46||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662069|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-7.5|Standard Error of the Mean|5.598|<|0.0906|2-Sided|80.0|-14.69|-0.31||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662070|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-1.93|Standard Error of the Mean|5.676|<|0.3672|2-Sided|80.0|-9.22|5.36||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662071|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-1.97|Standard Error of the Mean|5.674|<|0.3645|2-Sided|80.0|-9.26|5.32||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662429|NCT01509677|3058812|Superiority or Other (legacy)||Mean Difference (Final Values)|296.8|Standard Error of the Mean|124.07||0.0185|2-Sided|95.0|50.9|542.7|||ANCOVA|||2-sided 5% test|
1662072|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-24.79|Standard Error of the Mean|5.129|<|0.0001|2-Sided|80.0|-31.37|-18.2||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662073|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-11.62|Standard Error of the Mean|5.14|<|0.0122|2-Sided|80.0|-18.22|-5.02||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662074|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-4.45|Standard Error of the Mean|5.219|<|0.1974|2-Sided|80.0|-11.15|2.26||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662075|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-5.14|Standard Error of the Mean|5.191|<|0.1616|2-Sided|80.0|-11.8|1.53||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662076|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-21.34|Standard Error of the Mean|5.192|<|0.0001|2-Sided|80.0|-28.01|-14.67||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662077|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-13.74|Standard Error of the Mean|5.166|<|0.0041|2-Sided|80.0|-20.37|-7.1||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662078|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-6.12|Standard Error of the Mean|5.21|<|0.1204|2-Sided|80.0|-12.81|0.57||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662079|NCT01517373|3058037|Superiority or Other||LS Mean Difference|-2.09|Standard Error of the Mean|5.222|<|0.3446|2-Sided|80.0|-8.8|4.62||P-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662080|NCT01517373|3058038|Superiority or Other||LS Mean Difference|-0.66|Standard Error of the Mean|0.117|<|0.0001|2-Sided|80.0|-0.81|-0.51||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662081|NCT01517373|3058038|Superiority or Other||LS Mean Difference|-0.34|Standard Error of the Mean|0.117|<|0.0022|2-Sided|80.0|-0.49|-0.19||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662082|NCT01517373|3058038|Superiority or Other||LS Mean Difference|-0.16|Standard Error of the Mean|0.119|<|0.0878|2-Sided|80.0|-0.31|-0.01||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662083|NCT01517373|3058038|Superiority or Other||LS Mean Difference|0.05|Standard Error of the Mean|0.118|<|0.6618|2-Sided|80.0|-0.1|0.2||P-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662084|NCT01517373|3058038|Superiority or Other||LS Mean Difference|-0.57|Standard Error of the Mean|0.1|<|0.0001|2-Sided|80.0|-0.7|-0.44||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662085|NCT01517373|3058038|Superiority or Other||LS Mean Difference|-0.32|Standard Error of the Mean|0.099|<|0.0006|2-Sided|80.0|-0.45|-0.2||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662086|NCT01517373|3058038|Superiority or Other||LS Mean Difference|-0.07|Standard Error of the Mean|0.101|<|0.2606|2-Sided|80.0|-0.19|0.06||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662087|NCT01517373|3058038|Superiority or Other||LS Mean Difference|0.03|Standard Error of the Mean|0.101|<|0.6146|2-Sided|80.0|-0.1|0.16||P-value was 1-sided.|t-test, 1 sided|||Week 6: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662088|NCT01517373|3058038|Superiority or Other||LS Mean Difference|-0.44|Standard Error of the Mean|0.086|<|0.0001|2-Sided|80.0|-0.55|-0.33||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662149|NCT01516008|3058134|Superiority or Other||Mean Difference (Net)|19.11|||<|0.001|2-Sided|95.0|13.6|24.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.|12 hours|
1662089|NCT01517373|3058038|Superiority or Other||LS Mean Difference|-0.24|Standard Error of the Mean|0.086|<|0.0032|2-Sided|80.0|-0.35|-0.13||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80%CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662090|NCT01517373|3058038|Superiority or Other||LS Mean Difference|-0.14|Standard Error of the Mean|0.088|<|0.055|2-Sided|80.0|-0.25|-0.03||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662091|NCT01517373|3058038|Superiority or Other||LS Mean Difference|0.02|Standard Error of the Mean|0.087|<|0.6112|2-Sided|80.0|-0.09|0.14||P-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1662092|NCT01517373|3058039|Superiority or Other||LS Mean Difference|-0.83|Standard Error of the Mean|0.144|<|0.0001|2-Sided|80.0|-1.02|-0.65||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.|
1662093|NCT01517373|3058039|Superiority or Other||LS Mean Difference|-0.47|Standard Error of the Mean|0.144|<|0.0006|2-Sided|80.0|-0.65|-0.28||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.|
1662094|NCT01517373|3058039|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.146|<|0.0218|2-Sided|80.0|-0.48|-0.11||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, duration of T2DM time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.|
1662095|NCT01517373|3058039|Superiority or Other||Least Squares (LS) Mean Difference|-0.02|Standard Error of the Mean|0.145|<|0.4468|2-Sided|80.0|-0.21|0.17||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment,duration of type 2 diabetes mellitus (T2DM),time and treatment-by-time interaction as fixed effects,baseline as the covariate,time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.|
1662096|NCT01516970|3058066|Superiority or Other|||||||0.8839||||||The percentage of participants with TEAEs were compared with a statistical test (Fisher's Exact Test) with p-value: 0.8839.|Fisher Exact||||
1662097|NCT01516970|3058067|Superiority or Other|||||||0.2434||||||The discontinuation rates were compared with a statistical test (Cochran-Mantel-Haenszel [CMH]-Test) with p-value: 0.2434|Cochran-Mantel-Haenszel||||
1662098|NCT01516879|3058071|Superiority or Other||LS Mean Treatment Difference|-0.14|Standard Error of the Mean|1.84||0.94|2-Sided|95.0|-3.76|3.48|||ANCOVA|The ANCOVA model includes treatment group and stratification factor as covariates.|Treatment difference using placebo as the reference.||
1662099|NCT01516879|3058072|Superiority or Other||LS Mean Treatment Difference|-29.15|Standard Error of the Mean|5.64|<|0.001|2-Sided|95.0|-40.23|-18.08|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.||
1662100|NCT01516879|3058073|Superiority or Other||LS Mean Treatment Difference|5.42|Standard Error of the Mean|1.09|<|0.001|2-Sided|95.0|3.28|7.56|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.||
1662101|NCT01516879|3058074|Superiority or Other||LS Mean Treatment Difference|-11.54|Standard Error of the Mean|2.89|<|0.001|2-Sided|95.0|-17.21|-5.86|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.||
1662102|NCT01516879|3058075|Superiority or Other||LS Mean Treatment Difference|-22.35|Standard Error of the Mean|1.94|<|0.001|2-Sided|95.0|-26.15|-18.55|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.||
1662103|NCT01516879|3058076|Superiority or Other||LS Mean Treatment Difference|-46.21|Standard Error of the Mean|1.82|<|0.001|2-Sided|95.0|-49.79|-42.63|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.||
1662104|NCT01516879|3058077|Superiority or Other||LS Mean Treatment Difference|-37.14|Standard Error of the Mean|1.67|<|0.001|2-Sided|95.0|-40.41|-33.87|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.||
1662105|NCT01516879|3058078|Superiority or Other||LS Mean Treatment Difference|-44.21|Standard Error of the Mean|1.71|<|0.001|2-Sided|95.0|-47.56|-40.85|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.||
1662899|NCT01499511|3059784|Superiority|||||||0.915|||||||ANOVA||||
1662900|NCT01499511|3059785|Superiority|||||||0.641|||||||ANOVA||||
1662106|NCT01516879|3058079|Superiority or Other||LS Mean Treatment Difference|-50.27|Standard Error of the Mean|2.03|<|0.001|2-Sided|95.0|-54.25|-46.28|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.||
1662107|NCT01516879|3058080|Superiority or Other||LS Mean Treatment Difference|-33.45|Standard Error of the Mean|1.41|<|0.001|2-Sided|95.0|-36.21|-30.68|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.||
1662108|NCT01516879|3058081|Superiority or Other||LS Mean Treatment Difference|-35.15|Standard Error of the Mean|1.04|<|0.001|2-Sided|95.0|-37.19|-33.11|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.||
1662109|NCT01516879|3058082|Superiority or Other||LS Mean Treatment Difference|-57.51|Standard Error of the Mean|1.56|<|0.001|2-Sided|95.0|-60.57|-54.45|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.||
1662110|NCT01516879|3058083|Superiority or Other||Treatment Difference|75.8|||<|0.001|2-Sided|95.0|70.8|79.7|||Cochran-Mantel-Haenszel|CMH test stratified by the stratification factor. For testing, non-achievement was imputed for participants with a missing value at Week 52.|Treatment difference using placebo as the reference.||
1662111|NCT01516879|3058084|Superiority or Other||LS Mean Treatment Difference|-57.8|Standard Error of the Mean|2.3|<|0.001|2-Sided|95.0|-62.3|-53.3|||Repeated measures linear effects model|The model includes treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.||
1662112|NCT01516879|3058085|Superiority or Other||LS Mean Treatment Difference|-56.97|Standard Error of the Mean|2.1|<|0.001|2-Sided|95.0|-61.08|-52.85|||Repeated measures linear effects model|The model included treatment group, stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates.|Treatment difference using placebo as the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 52 in LDL-C between evolocumab 420 mg and placebo, and the alternative hypothesis was that a mean difference did exist.|
1662113|NCT01516749|3058088|Superiority or Other|||||||0.019||||||Significance was accepted at p<0.05|t-test, 2 sided|||Significance of reductions in Patient Global Assessment mean values between baseline and 8 weeks of therapy|
1662114|NCT01516749|3058088|Superiority or Other|||||||0.006||||||Significance was accepted at p<0.05|t-test, 2 sided|||Significance of reductions in Physican Global Assessment mean values between baseline and 8 weeks of therapy|
1662115|NCT01516749|3058089|Superiority or Other|||||||0.024||||||significance was accepted at p<0.05|t-test, 2 sided|||Significance of decrease in modified Sartorius score from Baseline to 8 weeks|
1662116|NCT01516736|3058097|Non-Inferiority|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|-0.16||||0.05|2-Sided|95.0|-0.4|0.08|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).||"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:~that LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,~that LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1."|
1662117|NCT01516736|3058097|Equivalence|The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.|Mean Difference (Net)|-0.16||||0.05|2-Sided|95.0|-0.4|0.08|||ANCOVA|The primary endpoints was analyzed with analysis of covariance (ANCOVA).||"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:~that LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,~that LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1."|
1662118|NCT01516684|3058098|Other|Marginal mixed model (GEE type)||||||0.426|||||||Mixed Models Analysis||||
1662119|NCT01516684|3058099|Other|||||||0.382|||||||Chi-squared||||
1662120|NCT01516684|3058100|Other|Marginal mixed model (GEE type)||||||0.094|||||||Mixed Models Analysis||||
1662121|NCT01516684|3058102|Other|||||||0.036|||||||T-test and chi-square|||Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate for the outcome. GEE methods will be used when analyzing the percentage of times additional propofol was administered. Mixed model regression methods will be used when analyzing the total dose administered.|
1662122|NCT01516632|3058103|Superiority or Other||Odds Ratio (OR)|3.33|||||2-Sided|95.0|1.48|7.45|||||||
1662123|NCT01516632|3058104|Superiority or Other||Odds Ratio (OR)|2.55|||||2-Sided|95.0|1.22|5.3|||||||
1662124|NCT01516632|3058105|Superiority or Other||Odds Ratio (OR)|1.62|||||2-Sided|95.0|0.82|3.21|||||||
1662125|NCT01516424|3058125|Non-Inferiority or Equivalence|The power is 80%, non-inferiority margin is 7.0.|Mean Difference (Final Values)|2.94|||<|0.05|2-Sided|95.0|-0.76|6.65||Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.|ANCOVA|Study center and grouping as fixed effects.|This is PPS analysis data.|"ANCOVA was employed to compare the changes of PANSS total scores at end of treatment relative to the baseline in these 2 groups. LSMeans for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.~H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone> 7.0)."|
1662126|NCT01516424|3058125|Non-Inferiority or Equivalence|The power is 80%, non-inferiority margin is 7.0.|Mean Difference (Final Values)|3.69|||<|0.05|2-Sided|95.0|-0.36|7.75||Satisfaction with the non-inferiority criteria was determined by the upper limit of confidence interval. If the upper limit of 95% confidence interval was less than 7.0, then non-inferiority was concluded.|ANCOVA|Study center and grouping as fixed effects.|This is ITT analysis data.|"ANCOVA was employed to compare the changes of PANSS scores at week 8 relative to the baseline in these 2 groups. Least Squares Means for the differences in changes between the 2 groups (μ blonanserin - μ risperidone) and the two-sided 95% Confidence Interval were calculated in accordance with the main model.~H0: Compared with risperidone, blonanserin reduced more than 7.0 in mean change in PANSS total score from baseline at week 8 of treatment (μ blonanserin-μ risperidone> 7.0)."|
1662127|NCT01516008|3058131|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center|||
1662128|NCT01516008|3058131|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center|||
1662129|NCT01516008|3058132|Superiority or Other||Mean Difference (Net)|192.05|||<|0.001|2-Sided|95.0|135.2|248.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group|72 hours|
1662130|NCT01516008|3058132|Superiority or Other||Mean Difference (Net)|178.91|||<|0.001|2-Sided|95.0|122.4|235.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group|72 hours|
1662131|NCT01516008|3058132|Superiority or Other||Mean Difference (Net)|124.21|||<|0.001|2-Sided|95.0|89.2|159.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group|48 hours|
1662132|NCT01516008|3058132|Superiority or Other||Mean Difference (Net)|111.12|||<|0.001||95.0|76.3|145.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group|48 hours|
1662133|NCT01516008|3058132|Superiority or Other||Mean Difference (Net)|58.58|||<|0.001|2-Sided|95.0|43.0|74.2|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group|24 hours|
1662134|NCT01516008|3058132|Superiority or Other||Mean Difference (Net)|49.93|||<|0.001|2-Sided|95.0|34.4|65.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group|24 hours|
1662135|NCT01516008|3058132|Superiority or Other||Mean Difference (Net)|26.24|||<|0.001|2-Sided|95.0|18.9|33.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group|12 hours|
1662136|NCT01516008|3058132|Superiority or Other||Mean Difference (Net)|23.66|||<|0.001|2-Sided|95.0|16.4|30.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate|Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group|12 hours|
1662137|NCT01516008|3058133|Superiority or Other||Mean Difference (Net)|53.48|||<|0.001|2-Sided|95.0|36.2|70.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group|72 hours|
1662138|NCT01516008|3058133|Superiority or Other||Mean Difference (Net)|56.59|||<|0.001|2-Sided|95.0|39.4|73.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group|72 hours|
1662139|NCT01516008|3058133|Superiority or Other||Mean Difference (Net)|33.6|||<|0.001|2-Sided|95.0|23.0|44.2|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group|48 hours|
1662140|NCT01516008|3058133|Superiority or Other||Mean Difference (Net)|34.76|||<|0.001|2-Sided|95.0|24.3|45.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group|48 hours|
1662141|NCT01516008|3058133|Superiority or Other||Mean Difference (Net)|15.54|||<|0.001|2-Sided|95.0|10.9|20.2|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group|24 hours|
1662142|NCT01516008|3058133|Superiority or Other||Mean Difference (Net)|15.21|||<|0.001|2-Sided|95.0|10.6|19.8|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group|24 hours|
1662143|NCT01516008|3058133|Superiority or Other||Mean Difference (Net)|7.13|||<|0.001|2-Sided|95.0|4.9|9.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group|12 hours|
1662144|NCT01516008|3058133|Superiority or Other||Mean Difference (Net)|7.15|||<|0.001|2-Sided|95.0|5.0|9.3|||ANCOVA|ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate|Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group|12 hours|
1662145|NCT01516008|3058134|Superiority or Other||Mean Difference (Net)|138.57|||<|0.001||95.0|97.8|179.4|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.|72 hours|
1662146|NCT01516008|3058134|Superiority or Other||Mean Difference (Net)|122.32|||<|0.001|2-Sided|95.0|81.8|162.9|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.|72 hours|
1662147|NCT01516008|3058134|Superiority or Other||Mean Difference (Net)|43.04|||<|0.001|2-Sided|95.0|31.5|54.6|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.|24 hours|
1662430|NCT01509677|3058813|Superiority or Other (legacy)||Mean Difference (Final Values)|27.79|Standard Error of the Mean|18.039||0.1264|2-Sided|95.0|-7.97|63.55|||ANCOVA|||2-sided 5% test|
1662150|NCT01516008|3058134|Superiority or Other||Mean Difference (Net)|16.52|||<|0.001|2-Sided|95.0|11.1|22.0|||ANCOVA|ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.|12 hours|
1662151|NCT01516008|3058135|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours|
1662152|NCT01516008|3058135|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours|
1662153|NCT01516008|3058135|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours|
1662154|NCT01516008|3058135|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours|
1662155|NCT01516008|3058135|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours|
1662156|NCT01516008|3058135|Superiority or Other||||||<|0.021|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours|
1662157|NCT01516008|3058135|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours|
1662158|NCT01516008|3058135|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours|
1662159|NCT01516008|3058136|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours|
1662160|NCT01516008|3058136|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||72 hours|
1662161|NCT01516008|3058136|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours|
1662162|NCT01516008|3058136|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||48 hours|
1662163|NCT01516008|3058136|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours|
1662164|NCT01516008|3058136|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||24 hours|
1662165|NCT01516008|3058136|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours|
1662166|NCT01516008|3058136|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Controlling for center||12 hours|
1662167|NCT01516008|3058137|Superiority or Other||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||72 hours|
1662168|NCT01516008|3058137|Superiority or Other||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||72 hours|
1662169|NCT01516008|3058137|Superiority or Other||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||48 hours|
1662170|NCT01516008|3058137|Superiority or Other||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||48 hours|
1662171|NCT01516008|3058137|Superiority or Other||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||24 hours|
1662172|NCT01516008|3058137|Superiority or Other||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||24 hours|
1662173|NCT01516008|3058137|Superiority or Other||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||12 hours|
1662174|NCT01516008|3058137|Superiority or Other||||||<|0.001|||||||Log Rank|Between-group comparison of cumulative distributions of percent reduction||12 hours|
1662175|NCT01516008|3058138|Superiority or Other||||||<|0.001||||||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|Log Rank|Stratified by center|||
1662176|NCT01516008|3058138|Superiority or Other||||||<|0.001||||||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|Log Rank|Stratified by center|||
1662177|NCT01516008|3058139|Superiority or Other||Mean Difference (Net)|90.6|||<|0.001|2-Sided|95.0|65.1|116.1||P-value is adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.||
1662178|NCT01516008|3058139|Superiority or Other||Mean Difference (Net)|76.35|||<|0.001|2-Sided|95.0|51.0|101.7||P-value adjusted for multiple treatment group comparisons using the Hochberg method.|ANCOVA|ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.|Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.||
1662179|NCT01515943|3058150|Superiority or Other||Risk Difference (RD)|-7.0|||<|0.01|2-Sided|95.0|-27.0|17.0|||Bernard's exact test|A p-value was not reported in the manuscript results, but has been included here, reported directly from the analysis.||For the HB-C group, the association between completion of the computer vergence/accommodative therapy (CVAT) program (defined as achieving at least 15 stars for the jump vergence exercise) and overall success at 12 weeks was evaluated using Bernard's exact test.|
1662180|NCT01515943|3058156|Superiority or Other||Risk Difference (RD)|5.0||||0.52|2-Sided|97.5|-12.0|22.0||Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).|Binomial regression|Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)|Positive values for the treatment group difference favor the HB-C group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.|The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-P groups, assuming true population success percentages of 30% and 10% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (<28 points vs ≥28 points), mean NPC break (<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs <15 pd).|
1662204|NCT01515475|3058191|Other||Hazard Ratio, log|-18.0||||0.08|2-Sided|99.0|-42.0|8.0||Results are considered statistically significant if p<0.01.|Barnard's Exact Test|||"Analysis for the less hyperopic eye:~Barnard’s exact test was used to compare proportions between treatment groups."|
1662205|NCT01515475|3058191|Other||Mean Difference (Final Values)|-25.0||||0.013|2-Sided|99.0|-49.0|1.0||Results are considered statistically significant if p<0.01.|Barnard's Exact Test|||"Analysis for the more hyperopic eye:~Barnard’s exact test was used to compare proportions between treatment groups."|
1662181|NCT01515943|3058157|Superiority or Other||Risk Difference (RD)|-4.0||||0.56|2-Sided|97.5|-19.0|11.0||Linear contrasts performed with a type I error rate of 2.5% based on a Bonferroni adjustment (overall type I error rate of 5% for 2 pairwise treatment group comparisons).|Biniomial regression|Adjusted for baseline covariates of CISS score, mean NPC break and mean PFV blur. Linear contrasts performed with Bonferroni adjustment (alpha=0.025)|Negative values for the treatment group difference favor the HB-PU group. Results of the treatment group comparison are adjusted for baseline covariates of CISS, mean NPC break and mean PFV blur.|The primary outcome was success at 12 weeks. The sample size was computed to have 90% power to detect a treatment group difference between the HB-C versus HB-PU groups, assuming true population success percentages of 30% and 15% for the HB-C and HB-PU groups, respectively, with a type I error rate of 2.5%. The treatment group comparison was adjusted for baseline covariates of CISS score (<28 points vs ≥28 points), mean NPC break (<10 cm vs ≥10 cm) and mean PFV blur (≥15 pd vs <15 pd).|
1662182|NCT01515865|3058162|Superiority or Other||Mean Difference (Final Values)|-13.8||||0.3145|2-Sided|95.0|-37.6|9.8|||Fisher Exact||||
1662183|NCT01515748|3058172|Superiority|||||||0.0154||||||Threshold for statistical significance at 0.05.|Log Rank|||Analysis was performed using Kaplan-Meier method. Comparison was stratified based on site and TNM classification (T4/N-, T2/N+, T3-4/N+).|
1662184|NCT01515696|3058173|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1662185|NCT01515696|3058174|Superiority or Other||Median Difference (Final Values)|7.5||||0.05||95.0|||||Wilcoxon (Mann-Whitney)||||
1662186|NCT01515696|3058175|Superiority or Other||Median Difference (Net)|1.0||||0.61||95.0|||||Wilcoxon (Mann-Whitney)||||
1662187|NCT01515488|3058183|Superiority or Other||Mean Difference (Final Values)|32.3|Standard Error of the Mean|5.2|<|0.0005|2-Sided|95.0|22.1|42.6|||t-test, 2 sided|DF=331.2|||
1662188|NCT01515475|3058184|Other||Mean Difference (Final Values)|-19.0||||0.02|2-Sided|99.0|-40.0|2.0||Results are considered statistically significant if p<0.01.|Barnard's Exact Test|||Barnard’s exact test used to compare proportions between treatment groups.|
1662189|NCT01515475|3058184|Other||Mean Difference (Final Values)|5.0||||0.53|2-Sided|99.0|-14.0|26.0||Results are considered statistically significant if p<0.01.|Barnard's Exact Test|||Barnard’s exact test used to compare proportions between treatment groups|
1662190|NCT01515475|3058185|Other||Mean Difference (Final Values)|-0.1||||0.15|2-Sided|99.0|-0.4|0.1|||ANCOVA|||An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit and anisometropia at the most recent visit.|
1662191|NCT01515475|3058185|Other||Mean Difference (Final Values)|0.02||||0.74|2-Sided|99.0|-0.11|0.14||Results are considered statistically significant if p<0.01.|ANCOVA|||An analysis of covariance model was used to compare mean change in stereoacuity between treatment groups. The analysis controlled for age at the 3-year visit, anisometropia at the most recent visit, and stereoacuity at enrollment.|
1662192|NCT01515475|3058186|Other||Mean Difference (Final Values)|0.0|||||2-Sided|99.0|-17.0|17.0||||||Barnard’s exact test used to compare proportions between treatment groups.|
1662193|NCT01515475|3058186|Other||Mean Difference (Final Values)|-2.0||||0.51|2-Sided|99.0|-18.0|13.0||Results are considered statistically significant if p<0.01.|Barnard's Exact Test|||Barnard’s exact test used to compare proportions between treatment groups|
1662194|NCT01515475|3058187|Other||Mean Difference (Final Values)|-0.03||||0.25|2-Sided|99.0|-0.1|0.04||Results are considered statistically significant if p≤0.01.|ANCOVA|||An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.|
1662195|NCT01515475|3058187|Other||Mean Difference (Final Values)|-0.04||||0.21|2-Sided|99.0|-0.12|0.05||Results are considered statistically significant if p<0.01|ANCOVA|||An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups.|
1662196|NCT01515475|3058188|Other||Mean Difference (Final Values)|-4.0||||0.68|2-Sided|99.0|-24.0|16.0||Results are considered statistically significant if p≤0.01.|Barnard's Exact Test|||Barnard’s exact test was used to compare proportions between treatment groups.|
1662197|NCT01515475|3058188|Other||Mean Difference (Final Values)|-2.0||||0.51|2-Sided|99.0|-18.0|13.0||Results are considered statistically significant if p<0.01.|Barnard's Exact Test|||Barnard’s exact test was used to compare proportions between treatment groups.|
1662198|NCT01515475|3058189|Other||Mean Difference (Final Values)|-2.0||||0.79|2-Sided|99.0|-18.0|14.0||Results are considered statistically significant if p<0.01.|Barnard's Exact Test|||Barnard’s exact test was used to compare proportions between treatment groups.|
1662199|NCT01515475|3058189|Other||Mean Difference (Final Values)|-2.0||||0.51|2-Sided|99.0|-18.0|13.0||Results are considered statistically significant if p<0.01.|Barnard's Exact Test|||Barnard’s exact test was used to compare proportions between treatment groups.|
1662200|NCT01515475|3058190|Other||Mean Difference (Final Values)|-0.07||||0.15|2-Sided|99.0|-0.19|0.05|||ANCOVA|||"Test for Difference in Means in Worse-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p<0.01."|
1662201|NCT01515475|3058190|Other||Mean Difference (Final Values)|-0.05||||0.02|2-Sided|99.0|-0.12|0.01|||ANCOVA|||"Test for Difference in Means in Better-Seeing Eye: Younger Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p<0.01."|
1662202|NCT01515475|3058190|Other||Mean Difference (Final Values)|-0.02||||0.41|2-Sided|99.0|-0.06|0.03|||ANCOVA|||"Test for Difference in Means in Worse-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p<0.01."|
1662203|NCT01515475|3058190|Other||Mean Difference (Final Values)|0.01||||0.22|2-Sided|99.0|-0.02|0.04|||ANCOVA|||"Test for Difference in Means in Better-Seeing Eye: Older Cohort~An analysis of covariance model, adjusting for age at the 3-year visit and visual acuity at baseline, was used to compare mean visual acuity between treatment groups. Results are considered statistically significant if p<0.01."|
1662550|NCT01506479|3059211|Superiority||Mean Difference (Final Values)|14.3|||<|0.0001|2-Sided|95.0|12.0|16.6|||t-test, 2 sided||||
1662206|NCT01515475|3058192|Other||Mean Difference (Final Values)|0.22||||0.38|2-Sided|99.0|-0.43|0.86||Results are considered statistically significant if p≤0.01.|ANCOVA|||"Analysis for the less hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."|
1662207|NCT01515475|3058192|Other||Mean Difference (Final Values)|0.16||||0.53|2-Sided|99.0|-0.51|0.84||Results are considered statistically significant if p≤0.01.|ANCOVA|||"Analysis for the more hyperopic eye, Younger Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."|
1662208|NCT01515475|3058192|Other||Mean Difference (Final Values)|0.58||||0.002|2-Sided|99.0|0.1|1.06||Results are considered statistically significant if p<0.01.|ANCOVA|||"Analysis for the less hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."|
1662209|NCT01515475|3058192|Other||Mean Difference (Final Values)|0.6||||0.002|2-Sided|99.0|0.11|1.09||Results are considered statistically significant if p<0.01.|ANCOVA|||"Analysis for the more hyperopic eye, Older Cohort:~An analysis of covariance model adjusting for refractive error at enrollment was used to compare mean change in refractive error between treatment groups."|
1662210|NCT01515475|3058200|Other||Risk Difference (RD)|-13.0||||0.14|2-Sided|95.0|-31.0|4.0|||Barnard's Exact Test||||
1662211|NCT01515475|3058200|Other||Risk Difference (RD)|3.0||||0.72|2-Sided|95.0|-12.0|18.0|||Barnard's Exact Test||||
1662212|NCT01515410|3058208|Superiority or Other||Difference in Least Squares Mean|-6.86||||0.0471||95.0|-13.62|-0.09||This p-value indicates statistical significance at the 0.05 level.|ANCOVA|No subjects early-terminated from the study.||"Percent OFF Time (%)"|
1662213|NCT01515306|3058217|Superiority or Other (legacy)||Ratio of Geo LS means|0.97|||||2-Sided|90.0|0.83|1.13|||||||
1662214|NCT01515306|3058219|Superiority or Other (legacy)||Ratio of Geo LS means|1.09|||||2-Sided|90.0|0.93|1.29|||||||
1662215|NCT01515189|3058221|Superiority||Hazard Ratio (HR)|0.71|||||2-Sided|95.0|0.49|1.04|||||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg. Based on an unstratified Cox proportional hazards model for subset of participants with brain metastases.||
1662216|NCT01515189|3058227|Superiority||Hazard Ratio (HR)|0.89||||0.1548|2-Sided|95.0|0.76|1.04||Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).|Log Rank||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model||
1662217|NCT01515189|3058228|Superiority||Hazard Ratio (HR)|0.84||||0.04|2-Sided|95.0|0.7|0.99||Analysis stratified by ECOG performance status (0 vs. 1), prior treatment for metastatic melanoma (yes vs. no) and M-stage (M0/M1a/M1b vs. M1c without brain metastases vs. M1c with brain metastases).|Log Rank||Hazard of 10 mg/kg ipilimumab over hazard of 3 mg/kg, with 2-sided 95% confidence intervals are based on a Cox proportional hazards model||
1662218|NCT01515072|3058236|Superiority or Other|||||||0.37|||||||Log Rank|This is an unadjusted comparison|||
1662219|NCT01515072|3058237|Superiority or Other||Cox Proportional Hazard|0.19||||0.01|2-Sided|95.0|0.04|0.9|||Log Rank|Results of adjusted Cox proportional hazard analyses for six month death-censored kidney graft survival are shown below|The proportional hazard ratio favors RIPC group||
1662220|NCT01515072|3058238|Superiority or Other|||||||0.03|||||||Log Rank|This is an unadjusted comparison|||
1662221|NCT01515072|3058239|Superiority or Other|||||||0.5|||||||Fisher Exact|This is an unadjusted comparison|||
1662222|NCT01515072|3058240|Superiority or Other||Mean Difference (Final Values)|0.1||||0.006|2-Sided|95.0|0.03|0.17|||Regression, Linear|Final resistance was modeled on RIPC and adjusted for donor stratum and duration of perfusion.|Data shown above is the adjusted mean difference in final resistance in the RIPC group.||
1662223|NCT01515072|3058241|Superiority or Other|||||||0.36||||||Unadjusted analysis|Chi-squared||||
1662224|NCT01515072|3058241|Superiority or Other||Odds Ratio (OR)|1.62||||0.07|2-Sided|95.0|0.95|2.76||Adjusted analysis with recipient age as a continuous variable, sex, race as black versus not black, body mass index, diabetes, hypertension,antigen mismatches, donor age as a continuous variable and trial site.|Chi-squared||||
1662225|NCT01515072|3058242|Superiority or Other|||||||0.97|||||||Wilcoxon (Mann-Whitney)||||
1662226|NCT01515072|3058243|Superiority or Other||Median Difference (Final Values)|-4.7||||0.53|2-Sided|95.0|-10.1|19.5||P<0.05|Regression, Linear|Final flow was modeled on RIPC and adjusted for donor stratum and duration of perfusion|Data shown above is the the adjusted mean difference in final flow in RIPC group||
1662227|NCT01515072|3058244|Superiority or Other|||||||0.04||||||P<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison|||
1662228|NCT01515072|3058245|Superiority or Other|||||||0.48||||||P<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison|||
1662229|NCT01515072|3058246|Superiority or Other|||||||0.55||||||P<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison|||
1662230|NCT01515072|3058247|Superiority or Other|||||||0.55||||||P<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison|||
1662231|NCT01515072|3058248|Superiority or Other|||||||0.86|||||||Wilcoxon (Mann-Whitney)||||
1662232|NCT01515072|3058249|Superiority or Other|||||||0.63||||||P<0.05|Wilcoxon (Mann-Whitney)|This is an unadjusted comparison|||
1662233|NCT01515072|3058250|Superiority or Other||Mean Difference (Net)|-0.03||||0.7|2-Sided|95.0|-0.33|0.26||This is an unadjusted analysis. P < 0.05|t-test, 2 sided|Adjusted analyses are provided below.|0.03 less organs per donor in the RIPC group.|Sample Size A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.|
1662255|NCT01514240|3058344|Superiority or Other||LS mean difference between group|3.4|Standard Error of the Mean|1.14|||2-Sided|90.0|1.49|5.29|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662901|NCT01499511|3059786|Superiority|||||||0.304|||||||ANOVA||||
1662234|NCT01515072|3058251|Superiority or Other||Mean Difference (Net)|-0.08||||0.38|2-Sided|95.0|-0.37|0.21||This is an unadjusted comparison. P value < 0.05|t-test, 2 sided|Adjusted analyses for the RIPC effect are provided below.|0.08 less organs per donor in the RIPC group.|Sample Size and Power estimation: A sample size of at least 150 donors in each arm was estimated to provide 80% power to detect a difference of 0.44 of an organ recovered and 0.48 of an organ transplanted per donor. The difference criterion was chosen based on published results achieved with hormonal resuscitation in organ donors. 6 Pooled standard deviations (organs recovered: 1.35; organs transplanted: 1.5) from data of two OPOs were used.|
1662235|NCT01514760|3058265|Superiority or Other|||||||0.03|||||||ANCOVA|||This a comparison for participants with uncontrolled asthma at baseline and change in scores over time.|
1662236|NCT01514461|3058290|Superiority or Other||% change from reference treatment|-40.88||||0.0182|2-Sided|95.0|-63.99|-2.94|||Mixed Models Analysis|Mixed Model of Repeated Measurements|||
1662237|NCT01514461|3058290|Superiority or Other||% change from reference treatment|-28.78||||0.0538|2-Sided|95.0|-55.69|14.46|||Mixed Models Analysis|Mixed Model of Repeated Measurements|||
1662238|NCT01514370|3058323|Other|||||||0.271|||||||Chi-squared||||
1662239|NCT01514292|3058328|Superiority or Other|||||||0.0001|||||||Fisher Exact|||"Hence, the hypothesis is established as:~Ho: pi < 71.5% Ha: pi >71.5% Thus, the objective is to conclude that the proportion of G4 Sensor-YSI points in the present study meeting the 20 mg/dL/20% criterion is no worse than the existing FDA-approved SEVEN PLUS System. The null hypothesis will be rejected if pi observed in this study is greater than 71.5%, the G4 System performance is no worse than the historical performance of the existing FDA approved CGM system will be concluded."|
1662240|NCT01514240|3058329|Superiority or Other||LS mean difference between group|1.3|Standard Error of the Mean|0.85|||2-Sided|90.0|-0.15|2.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662241|NCT01514240|3058330|Superiority or Other||LS mean difference between group|1.6|Standard Error of the Mean|0.86|||2-Sided|90.0|0.19|3.04|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662242|NCT01514240|3058331|Superiority or Other||LS mean difference between group|1.8|Standard Error of the Mean|0.81|||2-Sided|90.0|0.42|3.12|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662243|NCT01514240|3058332|Superiority or Other||LS mean difference between group|1.2|Standard Error of the Mean|0.73|||2-Sided|90.0|0.01|2.43|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662244|NCT01514240|3058333|Superiority or Other||LS mean difference between group|6.6|Standard Error of the Mean|1.86|||2-Sided|90.0|3.56|9.72|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662245|NCT01514240|3058334|Superiority or Other||LS mean difference between group|4.3|Standard Error of the Mean|1.76|||2-Sided|90.0|1.4|7.25|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662246|NCT01514240|3058335|Superiority or Other||LS mean difference between group|4.9|Standard Error of the Mean|1.66|||2-Sided|90.0|2.14|7.65|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662247|NCT01514240|3058336|Superiority or Other||LS mean difference between group|3.8|Standard Error of the Mean|1.43|||2-Sided|90.0|1.44|6.19|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662248|NCT01514240|3058337|Superiority or Other||LS mean difference between group|2.6|Standard Error of the Mean|0.89|||2-Sided|90.0|1.15|4.09|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662249|NCT01514240|3058338|Superiority or Other||LS mean difference between group|2.4|Standard Error of the Mean|0.84|||2-Sided|90.0|0.96|3.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662250|NCT01514240|3058339|Superiority or Other||LS mean difference between group|2.0|Standard Error of the Mean|0.74|||2-Sided|90.0|0.73|3.19|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662251|NCT01514240|3058340|Superiority or Other||LS mean difference between group|2.0|Standard Error of the Mean|0.69|||2-Sided|90.0|0.89|3.17|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662252|NCT01514240|3058341|Superiority or Other||LS mean difference between group|3.3|Standard Error of the Mean|1.47|||2-Sided|90.0|0.9|5.76|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662253|NCT01514240|3058342|Superiority or Other||LS mean difference between group|4.1|Standard Error of the Mean|1.53|||2-Sided|90.0|1.58|6.64|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662254|NCT01514240|3058343|Superiority or Other||LS mean difference between group|3.8|Standard Error of the Mean|1.31|||2-Sided|90.0|1.64|5.97|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662256|NCT01514240|3058345|Superiority or Other||LS mean difference between group|14.1|Standard Error of the Mean|4.32|||2-Sided|90.0|6.9|21.23|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662257|NCT01514240|3058346|Superiority or Other||LS mean difference between group|12.6|Standard Error of the Mean|4.31|||2-Sided|90.0|5.4|19.72|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662258|NCT01514240|3058347|Superiority or Other||LS mean difference between group|12.6|Standard Error of the Mean|3.93|||2-Sided|90.0|6.07|19.11|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662259|NCT01514240|3058348|Superiority or Other||LS mean difference between group|10.5|Standard Error of the Mean|3.4|||2-Sided|90.0|4.86|16.14|||||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662260|NCT01514240|3058349|Superiority or Other||Difference of proportions|12.5|||||2-Sided|90.0|-2.44|26.68|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.||
1662261|NCT01514240|3058350|Superiority or Other||Difference of proportions|14.3|||||2-Sided|90.0|0.5|27.4|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.||
1662262|NCT01514240|3058351|Superiority or Other||Difference of proportions|7.1|||||2-Sided|90.0|-5.67|19.71|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.||
1662263|NCT01514240|3058352|Superiority or Other||Difference of proportions|16.1|||||2-Sided|90.0|0.85|30.29|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.||
1662264|NCT01514240|3058353|Superiority or Other||Difference of proportions|16.1|||||2-Sided|90.0|1.66|29.61|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.||
1662265|NCT01514240|3058354|Superiority or Other||Difference of proportions|14.3|||||2-Sided|90.0|0.5|27.4|||||90% CI calculated using the Newcombe-Wilson score method without continuity corrections.||
1662266|NCT01514240|3058358|Superiority or Other||LS mean difference between group|-21.4|Standard Error of the Mean|14.53||0.144|2-Sided|90.0|-45.47|2.74|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662267|NCT01514240|3058359|Superiority or Other||LS mean difference between group|-30.0|Standard Error of the Mean|12.05||0.014|2-Sided|90.0|-49.95|-9.96|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662268|NCT01514240|3058360|Superiority or Other||LS mean difference between group|-22.8|Standard Error of the Mean|11.89||0.058|2-Sided|90.0|-42.55|-3.09|||Mixed Models Analysis||The analysis using a MMRM analysis including a covariate of the corresponding score at baseline,fixed effects of time (as a categorical factor) and treatment and interaction between time and treatment group.||
1662269|NCT01514240|3058361|Superiority or Other||Difference of proportion|8.9||||0.208|2-Sided|90.0|-2.87|20.58|||Chi-squared||Differences in remission rate at Week 4 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction||
1662270|NCT01514240|3058362|Superiority or Other||Difference of proportion|1.8||||0.768|2-Sided|90.0|-8.54|12.15|||Chi-squared||Differences in remission rate at Week 2 between D9421-C 9 mg and Mesalazine 3 g along with their 2-sided 90% CIs calculated by the Newcombe-Wilson score method without continuity correction||
1662271|NCT01514240|3058363|Non-Inferiority or Equivalence|A 2-sided 90% CI for the observed difference in the primary outcome measure (remission rate) between the D9421-C 9mg group and the Mesalazine 3 g group was calculated at week 8 using the Newcombe-Wilson score method without continuity correction. Noninferiority was concluded if the lower limit of the 90% CI was higher than –10% in FAS Population.|Difference of proportion|5.4||||0.526|2-Sided|90.0|-8.49|18.94|||Chi-squared|||The primary objective of this study was to determine non-inferiority in the differences in remission rates at Week 8 for D9421-C 9 mg as compared to Mesalazine 3 g.|
1662272|NCT01514201|3058378|Other|This was descriptive in nature. Two of the first 5 patients who were escalated to 175 mg/m2 of temozolomide during the maintenance intra-patient dose escalation had dose-modifying toxicities (DMTs). Since the ad hoc stopping rule was met, intra-patient dose escalation was halted and all subsequent patients were to receive 135 mg/m2 of temozolomide during maintenance.|Percentage of patients with DMTs|40.0|||||2-Sided|||||||||Intra-patient dose escalation of temozolomide during maintenance was assessed based on similar rules employed in traditional 3+3 designs. For example intra-patient dose escalation would be halted if at any time 2 out of first 2-6 patients experienced dose-modifying toxicities at a given dose level or if 4 out of first 12 patients experienced dose-modifying toxicities at a given dose level.|
1662273|NCT01513551|3058417|Other||Risk Difference (RD)|9.5|||||2-Sided|95.0|1.1|17.7|||||||
1662274|NCT01513551|3058417|Other||Risk Difference (RD)|6.8|||||2-Sided|95.0|-1.4|15.0|||||||
1662275|NCT01513447|3058436|Superiority or Other||Mean Difference (Net)|102.0||||0.29|2-Sided|95.0|-230.0|171.0|||Wilcoxon (Mann-Whitney)||||
1662276|NCT01513447|3058437|Superiority or Other|||||||0.67|||||||Fisher Exact||||
1662277|NCT01513317|3058439|Superiority or Other||Difference in LS means|-1.69||||0.073|2-Sided|95.0|-3.55|0.17|||ANCOVA||The estimated parameter is the difference in LS means of the number of RBC transfusions during the 8 weeks of treament before unblinding at Week 13.||
1662278|NCT01513317|3058440|Superiority or Other||Difference in LS means|1.96||||0.363|2-Sided|95.0|-2.35|6.27|||ANCOVA||The estimated parameter is the difference in LS means for changes from baseline in bone marrow blasts at Week 13.||
1662279|NCT01513317|3058441|Superiority or Other||Difference in proportions|0.002||||0.986|2-Sided|95.0|-0.09|0.09|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants who did not require a blood transfusion in the 8 weeks of treatment before unblinding at Week 13.||
1662280|NCT01513317|3058442|Superiority or Other||Difference in proportions|0.042||||0.494|2-Sided|95.0|-0.06|0.15|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants achieving hemoglobin improvement at Week 13.||
1662281|NCT01513317|3058443|Superiority or Other||Difference in LS means|0.07||||0.872|2-Sided|95.0|-0.79|0.93|||ANCOVA||The estimated parameter is the difference in LS means of the change from baseline hemoglobin levels at Week 13.||
1662282|NCT01513317|3058444|Superiority or Other||Difference in proportions|0.082||||0.271|2-Sided|95.0|-0.03|0.2|||Cochran-Mantel-Haenszel||The estimated parameter is the difference in proportion of participants who had a reduction in RBC transfusion to treat the anemia of MDS.||
1662283|NCT01513291|3058445|Superiority or Other||Odds Ratio (OR)|1.0||||0.9737|2-Sided|95.0|0.7|1.5|||Generalized linear mixed effects model||Odds ratio is for MK-6096 / Placebo. The generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Treatment Period 1 (≤8, >8) as covariates.||
1662284|NCT01513291|3058446|Superiority or Other||Odds Ratio (OR)|1.2||||0.43093|2-Sided|95.0|0.7|2.0|||Generalized linear mixed effects model||Odds ratio is for MK-6096 / Placebo. The generalized linear mixed effects model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period 1 (≤8, >8) as covariates.||
1662285|NCT01513291|3058447|Superiority or Other||Risk Difference (RD)|-0.5||||0.24008|2-Sided|95.0|-1.4|0.4|||Constrained Longitudinal Analysis (cLDA)||Risk difference is for MK-6096 - Placebo. The cLDA model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period (≤8, >8) as covariates||
1662286|NCT01513291|3058448|Superiority or Other||Risk Difference (RD)|2.3|||||2-Sided|95.0|-4.0|8.9|||||Risk difference (MK-6096 - Placebo) was estimated based on the Miettinen & Nurminen method||
1662287|NCT01513291|3058449|Superiority or Other||Risk Difference (RD)|9.3|||||2-Sided|95.0|-3.4|21.6|||||Risk difference (MK-6096 - Placebo) was estimated based on the Miettinen & Nurminen method||
1662288|NCT01513291|3058450|Superiority or Other||Risk Difference (RD)|-0.4||||0.33153|2-Sided|95.0|-1.3|0.4|||Constrained Longitudinal Analysis (cLDA)||Risk difference is for MK-6096 - Placebo. The cLDA model included terms for treatment, time, treatment-by-time interaction, monthly migraine days during the Screening (Baseline) Period (≤8, >8) as covariates||
1662289|NCT01513239|3058457|Superiority or Other||Difference in Percentages|1.2|||||2-Sided|95.0|-2.7|5.2|||||MK-6072 + SOC minus Placebo + SOC||
1662290|NCT01513239|3058457|Superiority or Other||Difference in Percentages|-0.4|||||2-Sided|95.0|-4.2|3.3|||||MK-3415A + SOC minus Placebo + SOC||
1662291|NCT01513239|3058458|Superiority or Other||Difference in Percentages|0.0|||>|0.999|2-Sided|95.0|-1.0|1.0|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC||
1662292|NCT01513239|3058458|Superiority or Other||Difference in Percentages|0.0|||>|0.999|2-Sided|95.0|-1.0|1.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC||
1662293|NCT01513239|3058459|Superiority or Other||Difference in Percentages|-0.3||||0.308|2-Sided|95.0|-1.5|0.7|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC||
1662294|NCT01513239|3058459|Superiority or Other||Difference in Percentages|0.5||||0.328|2-Sided|95.0|-0.8|2.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC||
1662295|NCT01513239|3058460|Superiority or Other||Difference in Percentages|0.0||||0.997|2-Sided|95.0|-3.7|3.6|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC||
1662296|NCT01513239|3058460|Superiority or Other||Difference in Percentages|-0.2||||0.931|2-Sided|95.0|-3.8|3.5|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC||
1662297|NCT01513239|3058461|Superiority or Other||Difference in Percentages|-2.3||||0.517|2-Sided|95.0|-9.2|4.6|||Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC||
1662298|NCT01513239|3058461|Superiority or Other||Difference in Percentages|-2.9||||0.408|2-Sided|95.0|-9.8|4.0|||Miettinen and Nurminen||MK-3415A + SOC minus Placebo +SOC||
1662299|NCT01513239|3058462|Superiority or Other||Adjusted Difference|1.6||||0.6962|2-Sided|95.0|-4.6|8.0||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC||
1662300|NCT01513239|3058462|Superiority or Other||Adjusted Difference|-13.7|||<|0.0001|2-Sided|95.0|-20.4|-6.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC||
1662301|NCT01513239|3058462|Superiority or Other||Adjusted Difference|-11.9|||<|0.0006|2-Sided|95.0|-19.0|-4.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC||
1662302|NCT01513239|3058463|Superiority or Other||Adjusted Difference|-9.4||||0.9969|2-Sided|95.0|-16.1|-2.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC||
1662303|NCT01513239|3058463|Superiority or Other||Adjusted Difference|14.6|||<|0.0001|2-Sided|95.0|7.7|21.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC||
1662304|NCT01513239|3058463|Superiority or Other||Adjusted Difference|5.2|||<|0.0722|2-Sided|95.0|-1.8|12.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC||
1662305|NCT01513239|3058464|Superiority or Other||Adjusted Difference|-0.8||||0.3718|2-Sided|95.0|-5.9|4.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus MK-6072 + SOC||
1662374|NCT01511978|3058598|Superiority|||||||0.0001|||||||t-test, 2 sided||||
1662375|NCT01511978|3058599|Superiority||||||<|0.0001|||||||Fisher Exact||||
1662306|NCT01513239|3058464|Superiority or Other||Adjusted Difference|-9.9||||0.0003|2-Sided|95.0|-15.5|-4.3||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-6072 + SOC minus Placebo + SOC||
1662307|NCT01513239|3058464|Superiority or Other||Adjusted Difference|-10.7|||<|0.0001|2-Sided|95.0|-16.4|-5.1||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient)|Miettinen and Nurminen||MK-3415A + SOC minus Placebo + SOC||
1662308|NCT01512979|3058475|Superiority or Other||Odds Ratio (OR)|2.448||||0.0008||95.0|1.453|4.123||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic||||
1662309|NCT01512979|3058476|Superiority or Other||Odds Ratio (OR)|2.92||||0.0025||95.0|1.458|5.849||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic||||
1662310|NCT01512979|3058477|Superiority or Other||Odds Ratio (OR)|3.83||||0.0031||95.0|1.573|9.328||The model includes treatment and continuous baseline HbA1c.|Regression, Logistic||||
1662311|NCT01512979|3058479|Superiority or Other||Mean Difference (Final Values)|-16.9|Standard Error of the Mean|5.7||0.0032||95.0|-28.0|-5.7||The model includes treatment, continuous baseline HbA1c and continuous baseline FPG.|ANCOVA||||
1662312|NCT01512979|3058480|Superiority or Other||Mean Difference (Final Values)|-0.79|Standard Error of the Mean|0.17|<|0.0001||95.0|-1.13|-0.46||The model includes treatment and continuous baseline HbA1c.|ANCOVA||||
1662313|NCT01512797|3058493|Other|||||||0.028||||||P-value refers to paired t-test comparing pre-intervention and post-intervention timepoints in Sitagliptin group.|t-test, 2 sided|||Power analysis. Based on the effect of DPP-4 inhibitors in non-operated subjects with type 2 diabetes, showing a significant decrease in 120’ post-prandial glucose by 1.67 mmol/L ± 0.98 mmol/L after a MMT, we estimated that a sample size of 16 subjects per group will show post-prandial glucose differences between placebo and sitagliptin group with α = 0.05 for a power > 90%.|
1662314|NCT01512693|3058516|Superiority or Other||GMR|0.71|||||2-Sided|90.0|0.51|1.0||||||Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (moderate hepatic insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (moderate hepatic insufficiency / healthy) and 90% confidence intervals.|
1662315|NCT01512693|3058517|Non-Inferiority or Equivalence|Similarity will be concluded if the GMR (moderate hepatic insufficiency / healthy) is contained within the interval [0.40, 2.50].|GMR|0.85|||||2-Sided|90.0|0.61|1.19||||||Natural log-transformed plasma values were analyzed using an analysis of covariance (ANCOVA) model with a categorical factor for population (moderate hepatic insufficiency participants, healthy matched control participants) and continuous covariates for age and body mass index (BMI). Data are back transformed to geometric least-squares mean ratio (GMR) (moderate hepatic insufficiency / healthy) and 90% confidence intervals.|
1662316|NCT01512667|3058520|Superiority or Other||GMR|1.46|||||2-Sided|90.0|1.18|1.81||||||Natural log-transformed plasma values were analyzed using an ANCOVA model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and BMI. Data are back transformed to GMR (severe renal insufficiency / healthy) and 90% confidence intervals.|
1662317|NCT01512667|3058521|Non-Inferiority or Equivalence|Similarity will be concluded if the GMR (severe renal insufficiency / healthy) is contained within the interval [0.40, 2.50].|GMR|1.6|||||2-Sided|90.0|1.15|2.23||||||Natural log-transformed plasma values were analyzed using an analysis of covariance (ANCOVA) model with a categorical factor for population (severe renal insufficiency participants, healthy matched control participants) and continuous covariates for age and body mass index (BMI). Data are back transformed to geometric least-squares mean ratio (GMR) (severe renal insufficiency / healthy) and 90% confidence intervals.|
1662318|NCT01512368|3058530|Superiority or Other||Slope|0.089|Standard Error of the Mean|0.063|<|0.001|2-Sided|95.0|0.034|0.144||All reported p values are based on two-sided tests considering ≤0.05 as significant.|Regression, Linear|Adjusted for age, time of exercise, creatinine, waist to hip ratio, fat percentage, body mass index, mean rest heart rate, blood pressure.|Metabolic equivalents (METs) consumed were independently associated with the log of delta (final-basal) FGF21 levels.|FGF21 was log transformed to approximate normality before analyses. Null hypothesis was Ho = Y1 (FGF21 level at baseline) = Y2 (FGF21 level after two weeks of exercising). Power calculation was 80% with 60 participants evaluated (one group). To evaluate the effect of exercise on clinical and biochemical parameters, we used the difference between final – basal levels (“delta”).|
1662319|NCT01512264|3058540|Other|||||||0.263|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.14.|
1662320|NCT01512264|3058540|Other|||||||0.12|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.10.|
1662321|NCT01512264|3058540|Other|||||||0.212|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 2.71.|
1662322|NCT01512264|3058540|Other|||||||0.239|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -3.12.|
1662323|NCT01512264|3058541|Other|||||||0.787|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.67.|
1662324|NCT01512264|3058541|Other|||||||0.148|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.68.|
1662427|NCT01509677|3058810|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.56|Standard Error of the Mean|1.309||0.6701|2-Sided|95.0|-3.15|2.03|||ANCOVA|||2-sided 5% test|
1662325|NCT01512264|3058541|Other|||||||0.8|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.97.|
1662326|NCT01512264|3058541|Other|||||||0.52|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and WAB test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.24.|
1662327|NCT01512264|3058543|Other|||||||0.14|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.84.|
1662328|NCT01512264|3058543|Other|||||||1|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.09.|
1662329|NCT01512264|3058543|Other|||||||0.519|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.19.|
1662330|NCT01512264|3058543|Other|||||||0.899|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.12.|
1662331|NCT01512264|3058544|Other|||||||0.341|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.43.|
1662332|NCT01512264|3058544|Other|||||||0.864|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.07.|
1662333|NCT01512264|3058544|Other|||||||0.485|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.|
1662334|NCT01512264|3058544|Other|||||||0.109|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and COWAT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.71.|
1662335|NCT01512264|3058546|Other|||||||0.518|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.60.|
1662336|NCT01512264|3058546|Other|||||||0.175|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.25.|
1662337|NCT01512264|3058546|Other|||||||0.695|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.25.|
1662338|NCT01512264|3058546|Other|||||||0.41|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.|
1662339|NCT01512264|3058547|Other|||||||0.147|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.70.|
1662340|NCT01512264|3058547|Other|||||||0.368|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment +1 week of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.37.|
1662341|NCT01512264|3058547|Other|||||||0.482|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 1 week of Sham Treatment + 2 weeks of nerTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.28.|
1662342|NCT01512264|3058547|Other|||||||0.118|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and SFT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.69.|
1662343|NCT01512264|3058549|Other|||||||0.019|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 4.35.|
1662344|NCT01512264|3058549|Other|||||||1|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 1.31.|
1662345|NCT01512264|3058549|Other|||||||0.618|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for 1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = 0.57.|
1662346|NCT01512264|3058549|Other|||||||0.41|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 5 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.|
1662347|NCT01512264|3058550|Other|||||||0.01|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the control group and BNT test were calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.63.|
1662348|NCT01512264|3058550|Other|||||||0.203|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the 2 weeks of Sham Treatment + 1 week of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -0.54.|
1662349|NCT01512264|3058550|Other|||||||0.015|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the1 week of Sham Treatment + 2 weeks of nerTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.27.|
1662350|NCT01512264|3058550|Other|||||||0.006|||||||t-test, 2 sided|||paired t- test between time point 1 and time point 4 for the rTMS group and BNT test was calculated. Cohen's d was calculated to determine the power of the test. The Cohen's d calculated for this test = -1.58.|
1662351|NCT01512160|3058585|Superiority or Other||Hazard Ratio (HR)|0.7|||||2-Sided|90.0|0.4|1.3||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1662352|NCT01512160|3058585|Superiority or Other||Hazard Ratio (HR)|1.3|||||2-Sided|90.0|0.7|2.4||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1662353|NCT01512160|3058585|Superiority or Other||Hazard Ratio (HR)|1.0|||||2-Sided|90.0|0.6|1.9||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1662354|NCT01512160|3058586|Superiority or Other||Hazard Ratio (HR)|1.5|||||2-Sided|90.0|0.7|2.9||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1662355|NCT01512160|3058586|Superiority or Other||Hazard Ratio (HR)|0.9|||||2-Sided|90.0|0.4|1.8||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1662356|NCT01512160|3058586|Superiority or Other||Hazard Ratio (HR)|1.0|||||2-Sided|90.0|0.5|2.1||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1662357|NCT01512160|3058587|Superiority or Other||Hazard Ratio (HR)|1.1|||||2-Sided|90.0|0.6|2.0||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1662358|NCT01512160|3058587|Superiority or Other||Hazard Ratio (HR)|1.2|||||2-Sided|90.0|0.7|2.1||||||HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1662359|NCT01512160|3058587|Superiority or Other||Hazard Ratio (HR)|0.8|||||2-Sided|90.0|0.5|1.5||||||Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.|
1662360|NCT01512160|3058588|Superiority or Other||LS mean difference|9.3|Standard Error of the Mean|9.5|||2-Sided|90.0|-6.6|25.1||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.|
1662361|NCT01512160|3058588|Superiority or Other||LS mean difference|-0.8|Standard Error of the Mean|9.4|||2-Sided|90.0|-16.5|14.8||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.|
1662362|NCT01512160|3058588|Superiority or Other||LS mean difference|0.2|Standard Error of the Mean|9.5|||2-Sided|90.0|-15.6|16.1||||||LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.|
1662363|NCT01512160|3058589|Superiority or Other||LS mean difference|7.6|Standard Error of the Mean|7.0|||2-Sided|90.0|-4.0|19.1||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.|
1662364|NCT01512160|3058589|Superiority or Other||LS mean difference|-0.1|Standard Error of the Mean|6.9|||2-Sided|90.0|-11.5|11.4||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.|
1662365|NCT01512160|3058589|Superiority or Other||LS mean difference|-1.0|Standard Error of the Mean|7.0|||2-Sided|90.0|-12.6|10.5||||||SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.|
1662366|NCT01512160|3058589|Superiority or Other||LS mean difference|2.8|Standard Error of the Mean|1.4|||2-Sided|90.0|0.4|5.1||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.|
1662367|NCT01512160|3058589|Superiority or Other||LS mean difference|-0.3|Standard Error of the Mean|1.4|||2-Sided|90.0|-2.7|2.0||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.|
1662368|NCT01512160|3058589|Superiority or Other||LS mean difference|-0.4|Standard Error of the Mean|1.4|||2-Sided|90.0|-2.8|1.9||||||SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.|
1662369|NCT01512160|3058593|Superiority or Other||LS mean difference|3.5|Standard Error of the Mean|1.9|||2-Sided|90.0|0.3|6.7||||||ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.|
1662370|NCT01512160|3058593|Superiority or Other||LS mean difference|-0.9|Standard Error of the Mean|1.9|||2-Sided|90.0|-4.1|2.3||||||ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.|
1662371|NCT01512160|3058593|Superiority or Other||Least squares (LS) mean difference|-1.1|Standard Error of the Mean|1.9|||2-Sided|90.0|-4.3|2.2||||||Analysis of co-variance (ANCOVA) model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90 percent (%) confidence interval (CI) was presented.|
1662372|NCT01512108|3058594|Superiority or Other||Estimated treatment difference, Mean|-0.3||||0.0458||95.0|-0.6|-0.01|||ANOVA||||
1662373|NCT01512108|3058595|Superiority or Other||Estimated treatment difference, Mean|-0.27||||0.0026||95.0|-0.44|-0.09|||ANOVA||||
1662376|NCT01511809|3058605|Non-Inferiority or Equivalence|A lower limit of the 95% confidence interval of the difference between the two proportions of treatment failure (triple therapy-monotherapy) below the pre-specified margin of non-inferiority of -10% established inferiority. A sample size of 342 patients (171 per treatment arm) provided 80% power (one-sided, alpha 0.05) to establish non-inferiority of ATV/r monotherapy as compared to ATV/r triple therapy with an overall treatment failure (TF) rate of 15% at week 48.|difference between TF proportions|15.0|||||2-Sided|||||||||"Here are reported the results of the 48-week interim analyses according to the intention-to-treat (ITT) principle. ITT=F (with re-intensification=failure) and the ITT=S (with re-intensification=success) treatment failure results are shown.~Based on the efficacy data review, in June 2013, an independent Data and Safety Monitoring Board (DSMB) recommended to stop further patients’ enrolment and to follow-up the enrolled patients until 96 weeks, after having signed an updated informed consent."|
1662377|NCT01511445|3058621|Non-Inferiority|The definition of fusion is rotation on flexion-extension films of less than or equal to four degrees and translation less than 1.25 mm.||||||0.71|||||||Fisher Exact|||The null hypothesis was that the fusion rates would be equal in the two study arms. The comparison includes patients with flexion-extension films at 24 months (as-treated population).|
1662378|NCT01511445|3058622|Non-Inferiority|The noninferiority margin was specified as 15 NDI points (0-100 scale).|Mean Difference (Final Values)|-1.3|Standard Error of the Mean|2.96||0.641|2-Sided|95.0|-7.3|4.5|||Fisher Exact||A negative value means that the PEEK change was slightly larger than the silicon nitride study arm.|The null hypothesis was that the mean change in NDI scores from pre-op to 24 months was equal in the two study arms.|
1662379|NCT01511107|3058664|Superiority or Other|||||||0.86|||||||Regression, Logistic|The p-value is adjusted for site & the stratification variables, namely age group & exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children for whom diaper dermatitis was reported.|
1662380|NCT01511107|3058665|Superiority or Other|||||||0.7|||||||Regression, Logistic|The p-value is adjusted for site & the stratification variables, namely age group & exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children for whom PDD was reported.|
1662381|NCT01511107|3058666|Superiority or Other|||||||0.07|||||||Generalized estimating equations|The p-value is adjusted for site & the stratification variables, episode, day of the diary and AOM-SOS score at the episode.||Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.|
1662382|NCT01511107|3058667|Superiority or Other||||||<|0.001|||||||Regression, Linear|The p-value is adjusted for site & the stratification variables and for length of follow-up.||Null hypothesis: There is no difference between the two groups in the mean number of days a systemic antibiotic was received during the respiratory season.|
1662383|NCT01511107|3058668|Superiority or Other|||||||0.22|||||||Regression, Poisson|The p-value is adjusted for site & the stratification variables, namely age group & exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within the entire respiratory season.|
1662384|NCT01511107|3058669|Superiority or Other|||||||0.23|||||||Regression, Poisson|The p-value is adjusted for site & the stratification variables, namely age group & exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the rate of recurrences/relapses within 60 days of enrollment.|
1662385|NCT01511107|3058670|Superiority or Other|||||||0.32|||||||Regression, Logistic|The p-value is adjusted for site & the stratification variables, namely age group & exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children completing the study having at least one AOM relapse or recurrence within the entire respiratory season.|
1662386|NCT01511107|3058671|Superiority or Other|||||||0.16|||||||Regression, Logistic|The p-value is adjusted for site & the stratification variables, namely age group & exposure or nonexposure to ≥3 children for ≥10 hours per week.||Null hypothesis: There is no difference between the two groups in the proportion of children followed greater than 60 days having at least one AOM relapse or recurrence within 60 days of enrollment.|
1662387|NCT01511107|3058672|Superiority or Other|||||||0.69|||||||Generalized estimating equations|The p-value is adjusted for H flu susceptibility at onset of the AOM recurrence.|||
1662388|NCT01511107|3058673|Superiority or Other|||||||0.47|||||||Regression, Logistic|The p-value is adjusted for H flu susceptibility at onset of the index episode.||Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible H flu isolate.|
1662389|NCT01511107|3058674|Superiority or Other|||||||0.05|||||||Generalized estimating equations|The p-value is adjusted for S pn susceptibility at onset of the AOM recurrence.|||
1662390|NCT01511107|3058675|Superiority or Other|||||||0.72|||||||Regression, Logistic|The p-value is adjusted for S pn susceptibility at the index episode.||Null hypothesis: There is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible S pn isolate.|
1662391|NCT01511107|3058676|Superiority or Other|||||||0.74|||||||Generalized estimating equations|||Null hypothesis: There is no difference in the proportion of 6 week follow-up, non-illness visits at which a penicillin-nonsusceptible pathogen is recovered.|
1662392|NCT01511107|3058677|Superiority or Other|||||||0.58|||||||Regression, Logistic|The p-value is adjusted for the culture result at enrollment.||Null hypothesis: There is no difference in the proportion of subjects whose NP isolates at enrollment are pathogen-negative or positive only for at least one susceptible pathogen who become colonized with penicillin non-susceptible pathogens at any time over the course of follow-up|
1662393|NCT01511107|3058678|Superiority or Other|||||||0.05|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is positive for one or more nonsusceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.|
1662394|NCT01511107|3058679|Superiority or Other|||||||0.47|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive for one or more nonsusceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.|
1662395|NCT01511107|3058680|Superiority or Other||||||>|0.99|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is positive only for one or more susceptible pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.|
1662396|NCT01511107|3058681|Superiority or Other|||||||0.59|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are positive only for one or more susceptible pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.|
1662397|NCT01511107|3058682|Superiority or Other|||||||0.95|||||||Generalized estimating equations|||Null hypothesis: For AOM recurrences with a NP culture at onset that is negative for AOM pathogens, there is no difference between the two groups regarding the proportion of NP cultures at Day 12-14 that yield a nonsusceptible pathogen.|
1662398|NCT01511107|3058683|Superiority or Other|||||||0.45|||||||Regression, Logistic|||Null hypothesis: There is no difference between the two groups in the proportion of children whose NP isolates at enrollment are negative for AOM pathogens for whom the NP culture at day 12-14 yields a nonsusceptible pathogen.|
1662399|NCT01511107|3058684|Non-Inferiority or Equivalence|A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.|Difference between proportions|-0.096|Standard Deviation|0.053|||2-Sided|95.0|-0.209|0.016|||||||
1662400|NCT01511107|3058685|Non-Inferiority or Equivalence|A noninferiority margin of 10% was used. Non-inferiority can be established by placing a confidence interval on the difference in the proportion of TFs in subjects randomized to the 10 day regimen and the proportion of TFs in subjects randomized to the 5 day regimen, and determining whether the lower 95% confidence bound is greater than -10%.|Difference between proportions|-0.172|Standard Deviation|0.039|||2-Sided|95.0|-0.253|-0.091||||||The null hypothesis that amoxicillin-clavulanate 5 days, placebo 5 days (reduced duration) is inferior to amoxicillin-clavulanate 10 days (standard duration) is tested against the alternative that reduced duration treatment is noninferior. Assuming failure rates of 15% and 25% in the standard and reduced duration groups, respectively, a 2-sided significance level of .05 and 10% attrition, it was calculated that 300 participants per group, would provide power of 95% for finding inferiority.|
1662401|NCT01510834|3058697|Superiority or Other||Mean Difference (Final Values)|-2.08|Standard Deviation|6.269||0.015|2-Sided|95.0|-3.751|-0.4244|||t-test, 2 sided||||
1662402|NCT01510834|3058698|Superiority or Other||Mean Difference (Final Values)|-3.78|Standard Deviation|7.78|<|0.001|2-Sided|95.0|-5.84|-1.7|||t-test, 2 sided||||
1662403|NCT01510834|3058699|Superiority or Other||Mean Difference (Final Values)|7.0872|Standard Deviation|15.731||0.001|2-Sided|95.0|2.91|11.26|||t-test, 2 sided||||
1662404|NCT01510834|3058700|Superiority or Other||Mean Difference (Final Values)|-6.824|Standard Deviation|14.148||0.001|2-Sided|95.0|-10.578|-3.07|||t-test, 2 sided||||
1662405|NCT01510769|3058701|Superiority or Other||Risk Difference (RD)|-0.19||||0.021|2-Sided|95.0|-0.34|-0.04|||Cochran-Mantel-Haenszel||||
1662406|NCT01510769|3058701|Superiority or Other||Risk Difference (RD)|-0.08||||0.3034|2-Sided|95.0|-0.24|0.07|||Cochran-Mantel-Haenszel||||
1662407|NCT01510769|3058702|Superiority or Other||Risk Difference (RD)|0.06||||0.4118|2-Sided|95.0|-0.08|0.19|||Cochran-Mantel-Haenszel||||
1662408|NCT01510769|3058702|Superiority or Other||Risk Difference (RD)|0.03||||0.645|2-Sided|95.0|-0.1|0.17|||Cochran-Mantel-Haenszel||||
1662409|NCT01510769|3058703|Superiority or Other||Risk Difference (RD)|0.09||||0.1149|2-Sided|95.0|-0.02|0.21|||Cochran-Mantel-Haenszel||||
1662410|NCT01510769|3058703|Superiority or Other||Risk Difference (RD)|0.04||||0.4453|2-Sided|95.0|-0.07|0.16|||Cochran-Mantel-Haenszel||||
1662411|NCT01510769|3058704|Superiority or Other||Risk Difference (RD)|0.29|||<|0.0001|2-Sided|95.0|0.17|0.42|||Cochran-Mantel-Haenszel||||
1662412|NCT01510769|3058704|Superiority or Other||Risk Difference (RD)|0.1|||<|0.1298|2-Sided|95.0|-0.03|0.23|||Cochran-Mantel-Haenszel||||
1662413|NCT01510158|3058745|Superiority or Other||Risk Difference (RD)|-0.08||||0.5974|2-Sided|95.0|-0.37|0.2|||Cochran-Mantel-Haenszel||||
1662414|NCT01510158|3058745|Superiority or Other||Risk Difference (RD)|-0.29||||0.0183|2-Sided|95.0|-0.51|-0.08|||Cochran-Mantel-Haenszel||||
1662415|NCT01510158|3058746|Superiority or Other||Risk Ratio (RR)|0.88||||0.6125|2-Sided|95.0|0.54|1.43|||Negative Binomial Regression||||
1662416|NCT01510158|3058746|Superiority or Other||Risk Ratio (RR)|0.99||||0.9796|2-Sided|95.0|0.61|1.61|||Negative Binomial Regression||||
1662417|NCT01510158|3058747|Superiority or Other||Risk Difference (RD)|0.31|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|0.22|0.41|||Cochran-Mantel-Haenszel||||
1662418|NCT01510158|3058747|Superiority or Other||Risk Difference (RD)|0.26|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|0.17|0.36|||Cochran-Mantel-Haenszel||||
1662419|NCT01509950|3058788|Superiority|||||||0.6|||||||t-test, 2 sided||||
1662420|NCT01509677|3058803|Superiority or Other (legacy)||Median Difference (Final Values)|-1.0||||0.2629|2-Sided|95.0|-2.0|1.0|||Wilcoxon (Mann-Whitney)|Between treatment difference||2 sided 5 % test|
1662421|NCT01509677|3058804|Superiority or Other (legacy)||Mean Difference (Final Values)|0.064|Standard Error of the Mean|0.0552||0.2482|2-Sided|95.0|-0.045|0.173|||ANCOVA|||2-sided 5% test|
1662422|NCT01509677|3058805|Superiority or Other (legacy)||Mean Difference (Final Values)|0.063|Standard Error of the Mean|0.03||0.038|2-Sided|95.0|0.004|0.122|||ANCOVA|||2-sided 5% test|
1662423|NCT01509677|3058806|Superiority or Other (legacy)||Mean Difference (Final Values)|32.8|Standard Error of the Mean|18.11||0.0728|2-Sided|95.0|-3.0|168.6|||ANCOVA|||2-sided 5% test|
1662424|NCT01509677|3058807|Superiority or Other (legacy)||Mean Difference (Final Values)|10.1|Standard Error of the Mean|4.49||0.0257|2-Sided|95.0|1.2|19.0|||ANCOVA|||2-sided 5% test|
1662425|NCT01509677|3058808|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.5|Standard Error of the Mean|15.62||0.9261|2-Sided|95.0|-32.4|29.5|||ANCOVA|||2-sided 5% test|
1662426|NCT01509677|3058809|Superiority or Other (legacy)||Mean Difference (Final Values)|1.8|Standard Error of the Mean|1.1||0.1105|2-Sided|95.0|-0.4|3.9|||ANCOVA|||2-sided 5% test|
1662431|NCT01509677|3058814|Superiority or Other (legacy)||Mean Difference (Final Values)|-25.9|Standard Error of the Mean|67.78||0.7033|2-Sided|95.0|-160.3|108.5|||ANCOVA|||2-sided 5% test|
1662432|NCT01509677|3058815|Superiority or Other (legacy)||Mean Difference (Final Values)|88.5|Standard Error of the Mean|79.26||0.2669|2-Sided|95.0|-68.6|245.6|||ANCOVA|||2-sided 5% test|
1662433|NCT01509677|3058816|Superiority or Other (legacy)||Mean Difference (Final Values)|711.1|Standard Error of the Mean|2768.79||0.7978|2-Sided|95.0|-4778.3|6200.5|||ANCOVA|||2-sided 5% test|
1662434|NCT01509677|3058817|Superiority or Other (legacy)||Mean Difference (Final Values)|0.16|Standard Error of the Mean|1.005||0.8769|2-Sided|95.0|-1.84|2.15|||ANCOVA|||2-sided 5% test|
1662435|NCT01509677|3058818|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.051|Standard Error of the Mean|0.1871||0.7862|2-Sided|95.0|-0.423|0.321|||ANCOVA|||2-sided 5 % test|
1662436|NCT01509677|3058819|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.867|Standard Error of the Mean|0.7331||0.0127|2-Sided|95.0|-3.324|-0.409|||ANCOVA|||2-sided 5 % test|
1662437|NCT01509677|3058820|Superiority or Other (legacy)||Mean Difference (Final Values)|1.141|Standard Error of the Mean|3.0057||0.7052|2-Sided|95.0|-4.835|7.117|||ANCOVA|||2-sided 5 % test|
1662438|NCT01509677|3058821|Superiority or Other (legacy)||Mean Difference (Final Values)|2.146|Standard Error of the Mean|3.3253||0.5205|2-Sided|95.0|-4.466|8.757|||ANCOVA|||2-sided 5 % test|
1662439|NCT01509677|3058822|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.0107|Standard Error of the Mean|0.01647||0.5175|2-Sided|95.0|-0.0435|0.022|||ANCOVA|||2 sided 5% test|
1662440|NCT01509677|3058823|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.0626|Standard Error of the Mean|0.03681||0.0927|2-Sided|95.0|-0.1358|0.0106|||ANCOVA|||2 sided 5% test|
1662441|NCT01509677|3058824|Superiority or Other (legacy)||Mean Difference (Final Values)|0.4727|Standard Error of the Mean|0.32866||0.1541|2-Sided|95.0|-0.181|1.1264|||ANCOVA|||2 sided 5% test|
1662442|NCT01509677|3058825|Superiority or Other (legacy)||Mean Difference (Final Values)|1.6354|Standard Error of the Mean|2.30185||0.4794|2-Sided|95.0|-2.9429|6.2137|||ANCOVA|||2 sided 5% test|
1662443|NCT01509677|3058826|Superiority or Other (legacy)||Risk Ratio (RR)|0.82|Standard Error of the Mean|0.177||0.3566|2-Sided|95.0|0.54|1.25|||Poisson regression model|||2-sided 5% test|
1662444|NCT01509677|3058827|Superiority or Other (legacy)||Risk Ratio (RR)|0.84|Standard Error of the Mean|0.082||0.0677|2-Sided|95.0|0.69|1.01|||Poisson regression model|||2-sided 5% test|
1662445|NCT01509677|3058828|Superiority or Other (legacy)||Risk Ratio (RR)|0.93|Standard Error of the Mean|0.164||0.674|2-Sided|95.0|0.66|1.31|||Regression, Linear|Poisson regression model||2-sided 5% test|
1662446|NCT01509677|3058829|Superiority or Other (legacy)||Risk Ratio (RR)|0.85|Standard Error of the Mean|0.086||0.1128|2-Sided|95.0|0.7|1.04|||Poisson regression model|||2-sided 5% test|
1662447|NCT01509677|3058830|Superiority or Other (legacy)||Risk Ratio (RR)|1.19|Standard Error of the Mean|0.194||0.2744|2-Sided|95.0|0.87|1.64|||Poisson regression model|||2-sided 5% test|
1662448|NCT01509677|3058831|Superiority or Other (legacy)||Mean Difference (Final Values)|11.4|Standard Error of the Mean|15.45||0.4606||95.0|-19.2|42.1|||ANCOVA|||2-sided 5% test|
1662449|NCT01509677|3058832|Superiority or Other (legacy)||Risk Ratio (RR)|1.04|Standard Error of the Mean|0.119||0.7136|2-Sided|95.0|0.83|1.3|||Poisson regression model|||2-sided 5% test|
1662450|NCT01509677|3058833|Superiority or Other (legacy)|||||||0.7145||||||"This is p-value testing significance of treatment effect"|Poisson regression model|||2-sided, 5% test|
1662451|NCT01509677|3058834|Superiority||Risk Ratio (RR)|1.03|Standard Error of the Mean|0.12||0.7917|2-Sided|95.0|0.82|1.3|||Poisson regression model||||
1662452|NCT01509677|3058834|Superiority or Other (legacy)|||||||0.7922||||||"This is p-value testing significance of treatment effect"|Poisson regression model|||2-sided test at 5% significant level|
1662453|NCT01509079|3058891|Superiority or Other|||||||0.38|||||||ANOVA||||
1662454|NCT01508936|3058923|Superiority or Other||Mean Difference (Final Values)|-0.123|Standard Error of the Mean|0.0762||0.1072|2-Sided|95.0|-0.273|0.027||significance level of 0.05|t-test, 2 sided|Fixed effects for treatment, hx of asthma exacerbation, sex, visit, and interaction of treatment and visit; covariates for height and baseline value|Active - Placebo|"The change from baseline over the 16 week treatment period was measured for the key secondary variables of:~Lung function as measured by FEV1~ACQ~Testing of the key secondary variables was performed using the sequential testing procedure in the order as specified above at the alpha level of 0.05."|
1662455|NCT01508936|3058924|Superiority or Other||Mean Difference (Final Values)|0.076|Standard Error of the Mean|0.0417||0.0697|2-Sided|95.0|-0.006|0.158||Statistical significance level is 0.05.|Regression, Linear|treatment, blood eosinophil count at baseline, and the interaction of treatment and eosinophil count as fixed effects.|Active - Placebo|"The change from baseline over the 16 week treatment period was measured for the key secondary variables of:~Lung function as measured by FEV1~ACQ~Testing of the key secondary variables was performed using the sequential testing procedure in the order as specified above at the alpha level of 0.05."|
1662456|NCT01508936|3058925|Superiority or Other||slope difference|0.3007|Standard Error of the Mean|0.2559||0.2407|2-Sided|||||The interaction was tested at the significance level 0.10 using the FAS|Regression, Linear||Active - Placebo|The primary analysis was the linear regression model with model effects including treatment (reslizumab or placebo), blood eosinophil count at baseline, and the interaction of treatment and eosinophil count. A significant treatment by baseline eosinophil interaction would indicate that treatment difference varies by the baseline eosinophil count.|
1662457|NCT01508702|3058933|Superiority or Other||Risk Ratio (RR)|0.28|||<|0.0001|2-Sided|95.0|0.19|0.37|||Cochran-Mantel-Haenszel||||
1662458|NCT01508676|3058936|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1662459|NCT01508130|3058971|Superiority or Other||Cox Proportional Hazard|0.88||||0.5649|2-Sided|95.0|0.57|1.36|||Wald residual chi-square test||95% CI for median was computed using the method of Brookmeyer and Crowley.||
1662460|NCT01508130|3058972|Superiority or Other||Cox Proportional Hazard|1.03||||0.9156|2-Sided|95.0|0.64|1.64|||Wald residual chi-square test||95% CI for median was computed using the method of Brookmeyer and Crowley.||
1662461|NCT01508130|3058979|Superiority or Other||Odds Ratio (OR)|1.27||||0.2594|2-Sided|95.0|0.84|1.92|||Multiple Logistic Regression||Without Propensity Score as a Covariate||
1662902|NCT01499511|3059787|Superiority|||||||0.004|||||||ANOVA||||
1662462|NCT01508130|3058979|Superiority or Other||Odds Ratio (OR)|0.93||||0.7695|2-Sided|95.0|0.58|1.49|||Multiple Logistic Regression||A multiple logistic regression model including a propensity score as a covariate (incorporated important demographics and baseline characteristics) was used for the treatment comparison.||
1662463|NCT01508130|3058980|Superiority or Other||Cox Proportional Hazard|1.02||||0.8826|2-Sided|95.0|0.78|1.34|||Wald residual chi-square test||Without Propensity Score as a Covariate.||
1662464|NCT01508130|3058980|Superiority or Other||Cox Proportional Hazard|1.08||||0.6451|2-Sided|95.0|0.78|1.49|||Wald residual chi-square test||Due to the non-interventional study design, the Cox model included a propensity score as a covariate (incorporated important demographics and baseline characteristics) to account for the potential imbalance between treatment groups.||
1662465|NCT01508013|3058983|Superiority or Other|||||||0.018|||||||Mixed Models Analysis||||
1662466|NCT01508013|3058984|Superiority or Other|||||||0.001|||||||Mixed Models Analysis||||
1662467|NCT01508013|3058985|Superiority or Other|||||||0.633|||||||Mixed Models Analysis||||
1662468|NCT01507831|3059016|Superiority or Other||LS Mean Difference|4.0|||<|0.0001|2-Sided|95.0|2.8|5.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662469|NCT01507831|3059017|Superiority or Other||Adjusted Mean Difference|-17.9|||<|0.0001|2-Sided|95.0|-20.5|-15.3||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662470|NCT01507831|3059018|Superiority or Other||LS Mean Difference|5.6|||<|0.0001|2-Sided|95.0|4.3|6.8||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662471|NCT01507831|3059019|Superiority or Other||Adjusted Mean Difference|-25.1|||<|0.0001|2-Sided|95.0|-27.4|-22.7||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662472|NCT01507831|3059020|Superiority or Other||LS Mean Difference|2.9|||<|0.0001|2-Sided|95.0|1.6|4.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662473|NCT01507831|3059021|Superiority or Other||Adjusted Mean Difference|-17.3|||<|0.0001|2-Sided|95.0|-20.1|-14.6||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662474|NCT01507831|3059022|Superiority or Other||LS Mean Difference|4.6|||<|0.0001|2-Sided|95.0|3.3|5.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662475|NCT01507831|3059023|Superiority or Other||Adjusted Mean Difference|-25.6|||<|0.0001|2-Sided|95.0|-28.1|-23.1||Threshold for significance ≤ 0.05.|Regression, Robust|Multiple imputation approach followed by a robust regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662476|NCT01507831|3059024|Superiority or Other||Odds Ratio (OR)|97.3|||<|0.0001|2-Sided|95.0|68.2|138.9||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662477|NCT01507831|3059025|Superiority or Other||Odds Ratio (OR)|74.6|||<|0.0001|2-Sided|95.0|53.3|104.4||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662478|NCT01507831|3059026|Superiority or Other||Odds Ratio (OR)|93.4|||<|0.0001|2-Sided|95.0|66.1|132.0||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662479|NCT01507831|3059027|Superiority or Other||Odds Ratio (OR)|71.5|||<|0.0001|2-Sided|95.0|51.6|99.1||Threshold for significance ≤ 0.05.|Regression, Logistic|Multiple imputation approach followed by logistic regression model.|Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662480|NCT01507831|3059028|Superiority or Other||LS Mean Difference|-39.0|||<|0.0001|2-Sided|95.0|-40.4|-37.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662481|NCT01507831|3059029|Superiority or Other||LS Mean Difference|-54.6|||<|0.0001|2-Sided|95.0|-56.6|-52.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662482|NCT01507831|3059030|Superiority or Other||LS Mean Difference|-56.0|||<|0.0001|2-Sided|95.0|-58.3|-53.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662483|NCT01507831|3059031|Superiority or Other||LS Mean Difference|-37.5|||<|0.0001|2-Sided|95.0|-39.1|-35.9||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662484|NCT01507831|3059032|Superiority or Other||LS Mean Difference|-53.7|||<|0.0001|2-Sided|95.0|-55.7|-51.6||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662485|NCT01507831|3059033|Superiority or Other||LS Mean Difference|-52.3|||<|0.0001|2-Sided|95.0|-54.4|-50.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662486|NCT01507831|3059034|Superiority or Other||LS Mean Difference|-55.5|||<|0.0001|2-Sided|95.0|-57.7|-53.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662487|NCT01507831|3059035|Superiority or Other||LS Mean Difference|-54.0|||<|0.0001|2-Sided|95.0|-56.3|-51.7||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662488|NCT01507831|3059036|Superiority or Other||LS Mean Difference|-61.3|||<|0.0001|2-Sided|95.0|-64.0|-58.5||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662489|NCT01507831|3059037|Superiority or Other||LS Mean Difference|-65.5|||<|0.0001|2-Sided|95.0|-67.9|-63.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662490|NCT01507831|3059038|Superiority or Other||LS Mean Difference|-64.8|||<|0.0001|2-Sided|95.0|-67.2|-62.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).|
1662491|NCT01507831|3059039|Superiority or Other||LS Mean Difference|-63.5|||<|0.0001|2-Sided|95.0|-65.9|-61.2||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|A hierarchial testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchial testing sequence continued only when previous endpoint was statistically significant at 0.05 level.|
1662492|NCT01507831|3059040|Superiority or Other||LS Mean Difference|-61.9|||<|0.0001|2-Sided|95.0|-64.3|-59.4||Threshold for significance ≤ 0.05.|Mixed Models Analysis||Alirocumab vs. Placebo|Alirocumab group was compared to placebo group using an appropriate contrast statement.|
1662493|NCT01507688|3059059|Superiority||Mean Difference (Net)|0.22|Standard Error of the Mean|0.04||0.26|2-Sided|||||Adjusted least square means (standard errors) adjusted for treatment (Intervention vs control), time of outcome from baseline (3, 6, 12 months), baseline SSQoL, Site (VA vs NonVA), Stroke/TIA diagnosis, sex (m vs f) and race (white vs nonwhite).|Mixed Models Analysis||Adjusted intervention arm's positive change (regression coefficient with standard error) in Total Stroke Specific Quality of Life was not significantly different at 12 months compared to the control group.|"We evaluated the mean difference on Total Stroke Specific Quality of Life compared to baseline between the intervention and control groups at 12 months using repeated measures ANCOVA models. We used primary outcome row Mean change from 0 to 12 months for this analysis."|
1662494|NCT01507688|3059059|Superiority||Mean Difference (Net)|0.14|Standard Error of the Mean|0.17||0.05|2-Sided|||||P-value was not adjusted for multiple comparisons. Models adjusted for: VA vs Non Va, admission diagnosis (transient ischemic attack vs stroke), sex (male vs female), white vs nonwhite, and baseline total Stroke Specific Quality of life score.|Mixed Models Analysis|Repeated measurements of change GEE analyses of Total Stroke Specific Quality of Life score change at 6 months from baseline.|The adjusted positive mean (standard error) change at 6 months from baseline was higher in the intervention arm compared to in the control arm. Intervention group had 0.14 (SE 0.17) higher improvement compared to the control group.|"All the sample size calculations were powered at 80% with a 5% Type I error. We estimated based on our pilot study a change difference of 0.25 on Total Stroke Specific Quality of Life in the intervention group compared to no change in the control group at 6 months. Our power calculations estimated a sample of 226 (113) per group was needed to detect this effect. We used primary outcome row Mean Change from 0 to 6 months for this analysis."|
1662495|NCT01507246|3059073|Superiority or Other||Ratio of geometric means|1.24||||0.02767|2-Sided|95.0|1.03|1.49|||least-squares mean ratio||Group 1 represents the numerator.|Null hypothesis = distribution of costs is identical between the two groups.|
1662496|NCT01507246|3059074|Superiority or Other||Ratio of geometric means|2.62||||0.0251|2-Sided|95.0|1.14|6.03|||least-squares mean ratio||Group 1 represents the numerator.|Null hypothesis: Mean ratio of geometric least-squares mean for each group is identical.|
1662497|NCT01507181|3059087|Superiority or Other|||||||0.17||||||Statistics are calculated by comparing 24-h scores using separate ANCOVAs and controlling for baseline severity.|ANCOVA||||
1662498|NCT01507181|3059088|Superiority or Other|||||||0.047|||||||t-test, 2 sided||||
1662499|NCT01507181|3059089|Superiority or Other|||||||0.32|||||||t-test, 2 sided||||
1662500|NCT01507103|3059096|Superiority or Other||LS Means estimate|0.21||||0.89|2-Sided|95.0|-0.32|0.74|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.|
1662501|NCT01507103|3059096|Superiority or Other||LS Means estimate|-0.19||||0.89|2-Sided|95.0|-0.7|0.31|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.|
1662551|NCT01506323|3059217|Superiority or Other||||||<|0.1||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|Mixed-effects, repeated measures models adjusting for demographic factors were implemented.||This analysis is from baseline to 2-months post-treatment.|
1662502|NCT01507103|3059096|Superiority or Other||LS Means estimate|0.02||||0.89|2-Sided|95.0|-0.54|0.58|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category:CD8+/GrB+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline=Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.|
1662503|NCT01507103|3059096|Superiority or Other||LS Means estimate|0.17||||0.921|2-Sided|95.0|-0.5|0.83|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.|
1662504|NCT01507103|3059096|Superiority or Other||LS Means estimate|-0.2||||0.921|2-Sided|95.0|-0.83|0.44|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.|
1662505|NCT01507103|3059096|Superiority or Other||LS Means estimate|-0.03||||0.921|2-Sided|95.0|-0.73|0.67|||type III SS F-test||Difference between Means adjusted on covariates baseline value and MSI category.|Category: CD8+ The difference in T cell infiltration from baseline to surgery was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value and MSI category as covariates. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B.|
1662506|NCT01507103|3059097|Superiority or Other||Effect estimate|0.21||||0.654|2-Sided|95.0|-0.31|0.74||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B|
1662507|NCT01507103|3059097|Superiority or Other||Effect estimate|-0.19||||0.654|2-Sided|95.0|-0.69|0.31||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B|
1662508|NCT01507103|3059097|Superiority or Other||Effect estimate|0.02||||0.654|2-Sided|95.0|-0.52|0.57||Arm effect|type III SS F-test|||Category: CD8+/GrB+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B|
1662509|NCT01507103|3059097|Superiority or Other||Effect estimate|0.16||||0.794|2-Sided|95.0|-0.49|0.82||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm B) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B|
1662510|NCT01507103|3059097|Superiority or Other||Effect estimate|-0.2||||0.794|2-Sided|95.0|-0.82|0.43||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm B vs Arm C) based on an ANCOVA model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B|
1662511|NCT01507103|3059097|Superiority or Other||Effect estimate|-0.04||||0.794|2-Sided|95.0|-0.72|0.65||Arm effect|type III SS F-test|||Category: CD8+ The difference between baseline and surgical tumor samples was analysed and compared across the 3 treatment arms (effect estimate for Arm A vs Arm C) based on an analysis of covariance (ANCOVA) model. Difference from baseline = Surgery value-Baseline value. Adjustment was based on ANCOVA model with treatment arm as factor and baseline value as covariate. No interaction included. Pairwise tests have been performed to compare Arm A with Arm C, Arm B with Arm C, and Arm A with Arm B|
1662512|NCT01507051|3059127|Superiority or Other||Geometric LS-Mean Ratio (%)|95.87||||0.4397||95.0|85.99|106.9|||ANOVA||||
1662513|NCT01507051|3059128|Superiority or Other||Geometric LS-Mean Ratio (%)|100.4||||0.9525||95.0|88.0|114.5|||ANOVA||||
1662514|NCT01507051|3059129|Superiority or Other||Geometric LS-Mean Ratio (%)|99.46||||0.9429||95.0|85.47|115.7|||ANOVA||||
1662515|NCT01507051|3059130|Superiority or Other||Geometric LS-Mean Ratio (%)|95.17||||0.5008||95.0|82.2|110.2|||ANOVA||||
1662516|NCT01507051|3059157|Superiority or Other||Geometric LS-Mean Ratio|6.151|||<|0.0001||90.0|5.598|6.759|||ANOVA||||
1662517|NCT01507051|3059158|Superiority or Other||Geometric LS-Mean Ratio|2.793|||<|0.0001||90.0|2.633|2.962|||ANOVA||||
1662552|NCT01506323|3059217|Superiority or Other||||||<|0.59||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for total score was .89 at baseline.|
1662518|NCT01506908|3059173|Superiority or Other||Least square mean difference|-17.9|||<|0.0001|2-Sided|95.0|-24.4|-11.4|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population’s change from post-cue baseline in craving score mean to be equal in both treatment groups at 10 minutes.|
1662519|NCT01506908|3059174|Superiority or Other||Least squares means difference|-17.8|||<|0.0001|2-Sided|95.0|-23.8|-11.7|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population’s change from post-cue baseline in craving score mean to be equal in both treatment groups at 7 minutes.|
1662520|NCT01506908|3059175|Superiority or Other||Least squares means difference|-11.6|||<|0.0001|2-Sided|95.0|-16.7|-6.4|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population’s change from post-cue baseline in craving score mean to be equal in both treatment groups at 3 minutes.|
1662521|NCT01506908|3059176|Superiority or Other||Least squares means difference|-4.2||||0.0511|2-Sided|95.0|-8.4|0.0|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population’s change from post-cue baseline in craving score mean to be equal in both treatment groups at 1 minute.|
1662522|NCT01506908|3059177|Superiority or Other||Least squares means difference|-15.9|||<|0.0001|2-Sided|95.0|-21.6|-10.2|||ANCOVA||Treatment comparisons were made between 4 mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered the population’s change from post-cue baseline in craving score mean to be equal in both treatment groups at 5 minutes|
1662523|NCT01506882|3059185|Superiority or Other||Percent|73.8|||||2-Sided|95.0|60.9|84.2||||||"The primary efficacy variable was to be calculated as the proportion p=n/N of subjects (n) staying seizure free for 6 months out of the total number of subjects (N). For this proportion p, an exact 2-sided 95% confidence interval (CI) was computed based on the F distribution.~The hypothesis H0: p=0.4 was to be formally rejected in favor of H1: p>0.4, if the lower confidence limit for p was greater than 0.4."|
1662524|NCT01506726|3059186|Superiority or Other|||||||0.412|||||||t-test, 2 sided||||
1662525|NCT01506726|3059187|Superiority or Other|||||||0.398|||||||t-test, 2 sided||||
1662526|NCT01506726|3059189|Superiority or Other|||||||0.375|||||||Chi-squared||||
1662527|NCT01506726|3059190|Superiority or Other||||||>|0.999|||||||Chi-squared||||
1662528|NCT01506726|3059191|Superiority or Other|||||||0.42|||||||t-test, 2 sided||||
1662529|NCT01506726|3059192|Superiority or Other|||||||0.642|||||||t-test, 2 sided||||
1662530|NCT01506726|3059193|Superiority or Other|||||||0.619|||||||t-test, 2 sided||||
1662531|NCT01506726|3059194|Superiority or Other|||||||0.193|||||||t-test, 2 sided||||
1662532|NCT01506726|3059195|Superiority or Other|||||||0.187|||||||t-test, 2 sided||||
1662533|NCT01506726|3059196|Superiority or Other||||||>|0.999|||||||Chi-squared||||
1662534|NCT01506726|3059197|Superiority or Other|||||||0.076|||||||t-test, 2 sided||||
1662535|NCT01506726|3059198|Superiority or Other|||||||0.232|||||||t-test, 2 sided||||
1662536|NCT01506726|3059199|Superiority or Other|||||||0.535||||||P-value comparing the change in EPO between treatment groups.|t-test, 2 sided||||
1662537|NCT01506726|3059200|Superiority or Other|||||||0.257||||||P value comparing the change in TNF between treatment groups.|t-test, 2 sided||||
1662538|NCT01506726|3059200|Superiority or Other|||||||0.143||||||P value comparing change in IL6 between treatment groups.|t-test, 2 sided||||
1662539|NCT01506726|3059201|Superiority or Other|||||||0.894||||||Correlation between change in CRP and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided||||
1662540|NCT01506726|3059201|Superiority or Other|||||||0.803||||||Correlation between change in CRP and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided||||
1662541|NCT01506726|3059201|Superiority or Other|||||||0.136||||||Correlation between change in TNF and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided||||
1662542|NCT01506726|3059201|Superiority or Other|||||||0.014||||||Correlation between change in TNF and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided||||
1662543|NCT01506726|3059201|Superiority or Other|||||||0.706||||||Correlation between change in IL-6 and change in hemoglobin in the placebo group. Testing the correlation equal to 0.|t-test, 2 sided||||
1662544|NCT01506726|3059201|Superiority or Other|||||||0.857||||||Correlation between change in IL-6 and change in hemoglobin in the salsalate group. Testing the correlation equal to 0.|t-test, 2 sided||||
1662545|NCT01506726|3059202|Superiority or Other|||||||0.347|||||||t-test, 2 sided||||
1662546|NCT01506726|3059203|Superiority or Other||Mean Difference (Final Values)|-0.94||||0.23|2-Sided|95.0|-2.08|0.2|||Wilcoxon (Mann-Whitney)|Wilcoxon two sample test|||
1662547|NCT01506479|3059209|Superiority|||||||0.1334|||||||t-test, 2 sided||||
1662548|NCT01506479|3059210|Other||Mean Difference (Final Values)|1.2||||0.03|1-Sided|90.0||2.8||The a priori threshold for statistical significance was set to 0.10. If the p-value is less than 0.10, the null hypothesis is rejected in favor of the alternative (moderate exercise does not warrant further investigation).|t-test, 1 sided||"The estimate is the difference between the control group and the moderate exercise group.~The upper bound of the confidence interval should be compared to the futility threshold of 3.5 to reject or not reject the null hypothesis."|The null hypothesis is that the moderate exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference in the mean change between the control group and the moderate exercise group). The alternative hypothesis is that moderate exercise does not warrant further investigation .|
1662549|NCT01506479|3059210|Other||Mean Difference (Final Values)|2.9||||0.34|1-Sided|90.0||4.6||The a priori threshold for statistical significance was 0.10|t-test, 1 sided|||The null hypothesis is that the vigorous exercise group warrants further investigation using a futility threshold of 3.5 compared to the control group (difference between the mean change in the control group and the mean change in the vigorous exercise group). The alternative hypothesis is that vigorous exercise does not warrant further investigation.|
1662691|NCT01505179|3059363|Superiority|||||||0.49|||||||Wilcoxon (Mann-Whitney)||||
1662553|NCT01506323|3059218|Superiority or Other||||||<|0.49||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.|
1662554|NCT01506323|3059218|Superiority or Other||||||<|0.12||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .88 at baseline.|
1662555|NCT01506323|3059219|Superiority or Other||||||<|0.94||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.|
1662556|NCT01506323|3059219|Superiority or Other||||||<|0.99||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.|
1662557|NCT01506323|3059220|Superiority or Other||||||<|0.25||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.|
1662558|NCT01506323|3059220|Superiority or Other||||||<|0.04||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis was from baseline to post-treatment. Cronbach's alpha for this study was .92 at baseline.|
1662559|NCT01506323|3059221|Superiority or Other||||||<|0.99||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2-months post-treatment.|
1662560|NCT01506323|3059221|Superiority or Other||||||<|0.78||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .96 at baseline.|
1662561|NCT01506323|3059222|Superiority or Other||||||<|0.49||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment.|
1662562|NCT01506323|3059222|Superiority or Other||||||<|0.1||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. Raw p-value was <0.02.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for total score in this study was .86 at baseline.|
1662563|NCT01506323|3059223|Superiority or Other||||||<|0.006||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Wilcoxon (Mann-Whitney)|||This analysis is from baseline to 2 months post-treatment.|
1662564|NCT01506323|3059223|Superiority or Other||||||<|0.0008||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.|
1662565|NCT01506323|3059224|Superiority or Other||||||<|0.03||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to 2 months post-treatment.|
1662566|NCT01506323|3059224|Superiority or Other||||||<|0.006||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .78 at baseline.|
1662567|NCT01506323|3059225|Superiority or Other||||||<|0.09||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2 months post-treatment|
1662568|NCT01506323|3059225|Superiority or Other||||||<|0.008||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|repeated measures|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .85 at baseline.|
1662569|NCT01506323|3059226|Superiority or Other|||||||0.82||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|||This analysis is from baseline to 2 months post-treatment.|
1662570|NCT01506323|3059226|Superiority or Other|||||||0.82||||||The p-value is based on false discovery rate adjustment for multiple comparisons.|Mixed Models Analysis|||This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .86 at baseline.|
1662571|NCT01506323|3059227|Superiority or Other||||||<|0.031||||||The p-value was adjusted for multiple comparisons using false discovery rate.|Mixed Models Analysis|This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.||This analysis is from baseline (week 0) to 2 months follow-up.|
1662572|NCT01506323|3059227|Superiority or Other||||||<|0.006||||||This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.|Mixed Models Analysis|Mixed-effects, repeated measures models adjusting for demographic factors were implemented.||This analysis is from baseline (week 0) to post-treatment (week 8). Cronbach's alpha for this study was .92 at baseline.|
1662573|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||2-Sided|95.0|-6.9|6.6|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Vascular disorders|
1662574|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.6|||||2-Sided|95.0|-9.9|2.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Vascular disorders|
1662575|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.0|||||2-Sided|95.0|-4.7|4.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Skin & subcutan.|
1662576|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|2.5|||||2-Sided|95.0|-2.4|8.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Skin & subcutan.|
1662577|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||2-Sided|95.0|-8.4|4.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Resp. & chest|
1662578|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-4.4|||||2-Sided|95.0|-10.7|0.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Resp. & chest|
1662692|NCT01505179|3059364|Superiority|||||||0.74|||||||t-test, 2 sided||||
1662693|NCT01505179|3059365|Superiority|||||||0.009|||||||Wilcoxon (Mann-Whitney)||||
1662579|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||2-Sided|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Renal & Urinary|
1662580|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||2-Sided|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Renal & Urinary|
1662581|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||2-Sided|95.0|-5.7|5.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Psychiatric disorders|
1662582|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.1|||||2-Sided|95.0|-5.7|5.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Psychiatric disorders|
1662583|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||2-Sided|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Nervous System|
1662584|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||2-Sided|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Nervous System|
1662585|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.9|||||2-Sided|95.0|-10.5|6.5|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Investigations|
1662586|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.2|||||2-Sided|95.0|-9.8|7.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Investigations|
1662587|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||2-Sided|95.0|-5.0|8.5|||||Relebactam minus Placebo|Relebactam 1250mg - Placebo: Percentage Difference - Injury, poison.|
1662588|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||2-Sided|95.0|-7.3|5.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Injury, poison.|
1662589|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.7|||||2-Sided|95.0|-6.5|8.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Infect. & Infest.|
1662590|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||2-Sided|95.0|-3.6|12.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Infect. & Infest.|
1662591|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||2-Sided|95.0|-4.2|7.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Gen. dis & admin.|
1662592|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.2|||||2-Sided|95.0|-2.0|11.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Gen. dis & admin.|
1662593|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||2-Sided|95.0|-5.4|13.6|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - GI disorders|
1662594|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|5.6|||||2-Sided|95.0|-3.9|15.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - GI disorders|
1662595|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||2-Sided|95.0|-4.5|6.3|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Cardiac disorder|
1662596|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||2-Sided|95.0|-5.2|5.0|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Cardiac disorder|
1662597|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-4.4|||||2-Sided|95.0|-10.3|0.1|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Blood, lymphatic|
1662598|NCT01506271|3059228|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.0|||||2-Sided|95.0|-7.3|5.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Blood, lymphatic|
1662599|NCT01506271|3059230|Non-Inferiority|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|1.4|||<|0.001|2-Sided|95.0|-5.2|8.6|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662600|NCT01506271|3059230|Non-Inferiority|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.0|||<|0.001|2-Sided|95.0|-7.4|7.4|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662601|NCT01506271|3059231|Non-Inferiority|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|0.4|||<|0.001|2-Sided|95.0|-7.2|8.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662602|NCT01506271|3059231|Non-Inferiority|Non-inferiority test based on Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.3|||<|0.002|2-Sided|95.0|-9.6|6.9|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662603|NCT01506271|3059232|Non-Inferiority|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.1|||<|0.001|2-Sided|95.0|-6.3|6.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662604|NCT01506271|3059232|Non-Inferiority|Eight participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|-0.1|||<|0.001|2-Sided|95.0|-6.7|6.4|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662903|NCT01499511|3059788|Superiority|||||||0.624|||||||ANOVA||||
1662605|NCT01506271|3059233|Non-Inferiority|Two participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|2.4|||<|0.001|2-Sided|95.0|-2.0|8.3|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662606|NCT01506271|3059233|Non-Inferiority|Two participants with indeterminate or missing response were excluded from the analysis.|Percentage Difference|0.0|||<|0.001|2-Sided|95.0|-6.3|6.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662607|NCT01506271|3059234|Non-Inferiority|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-2.1||||0.002|2-Sided|95.0|-9.7|5.3|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662608|NCT01506271|3059234|Non-Inferiority|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.4||||0.001|2-Sided|95.0|-9.1|6.0|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662609|NCT01506271|3059235|Superiority||Percentage Difference|0.0|||>|0.999|2-Sided|95.0|0.0|0.0|||Fisher Exact||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662610|NCT01506271|3059235|Superiority||Percentage Difference|0.0|||>|0.999|2-Sided|95.0|0.0|0.0|||Fisher Exact||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662611|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.9|||||2-Sided|95.0|-6.4|4.3|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Hypertension|
1662612|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.5|||||2-Sided|95.0|-8.7|-0.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Hypertension|
1662613|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||2-Sided|95.0|-7.2|3.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Lipase increased|
1662614|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.9|||||2-Sided|95.0|-6.5|4.2|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Lipase increased|
1662615|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||2-Sided|95.0|-3.7|7.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - AST increased|
1662616|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||2-Sided|95.0|-3.7|7.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - AST increased|
1662617|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||2-Sided|95.0|-4.9|6.7|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - ALT increased|
1662618|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.8|||||2-Sided|95.0|-5.0|6.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - ALT increased|
1662619|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.3|||||2-Sided|95.0|1.0|9.7|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Seroma|
1662620|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.9|||||2-Sided|95.0|-2.4|4.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Seroma|
1662621|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.7|||||2-Sided|95.0|-8.4|2.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Postoperative Infection|
1662622|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||2-Sided|95.0|-7.6|3.5|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Postoperative Infection|
1662623|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|5.1|||||2-Sided|95.0|-0.7|11.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Vomiting|
1662624|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|3.4|||||2-Sided|95.0|-2.3|9.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Vomiting|
1662625|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.7|||||2-Sided|95.0|-6.5|8.0|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Nausea|
1662626|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-0.2|||||2-Sided|95.0|-7.3|6.9|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Nausea|
1662627|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||2-Sided|95.0|-4.6|8.2|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference - Diarrhoea|
1662628|NCT01506271|3059236|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.6|||||2-Sided|95.0|-4.7|8.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference - Diarrhoea|
1662629|NCT01506271|3059237|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-1.8|||||2-Sided|95.0|-6.7|2.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662630|NCT01506271|3059237|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-2.6|||||2-Sided|95.0|-7.5|0.6|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662631|NCT01506271|3059238|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|1.7|||||2-Sided|95.0|-3.7|7.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662694|NCT01505179|3059366|Superiority|||||||0.47|||||||t-test, 2 sided||||
1662904|NCT01499355|3059795|Superiority or Other|||||||0.996|||||||ANCOVA||||
1662632|NCT01506271|3059238|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-1.8|||||2-Sided|95.0|-6.7|2.3|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662633|NCT01506271|3059239|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|-0.9|||||2-Sided|95.0|-4.8|2.4|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662634|NCT01506271|3059239|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|0.0|||||2-Sided|95.0|-4.0|3.9|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662635|NCT01506271|3059240|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.1|||||2-Sided|95.0|-4.4|12.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662636|NCT01506271|3059240|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|4.0|||||2-Sided|95.0|-4.5|12.7|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662637|NCT01506271|3059241|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|2.5|||||2-Sided|95.0|-5.0|10.1|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662638|NCT01506271|3059241|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|-3.6|||||2-Sided|95.0|-10.3|2.4|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662639|NCT01506271|3059242|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|6.2|||||2-Sided|95.0|-6.7|18.8|||||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662640|NCT01506271|3059242|Other|Unconditional asymptotic Miettinen and Nurminen method without stratification|Percentage Difference|7.5|||||2-Sided|95.0|-5.4|20.1|||||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662641|NCT01506271|3059243|Other|Test for a non-zero difference|Percentage Difference|0.0|||>|0.999|2-Sided|95.0|-3.3|3.2|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662642|NCT01506271|3059243|Other|Test for a non-zero difference.|Percentage Difference|0.9|||>|0.324|2-Sided|95.0|-2.4|4.7|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662643|NCT01506271|3059244|Other|Test for a non-zero difference.|Percentage Difference|-1.8||||0.153|2-Sided|95.0|-6.2|1.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662644|NCT01506271|3059244|Other|Test for a non-zero difference.|Percentage Difference|0.0||||0.979|2-Sided|95.0|-4.7|4.5|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 250 mg - Placebo: Percentage Difference|
1662645|NCT01506271|3059245|Non-Inferiority|Non-inferiority test based on unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|3.7|||<|0.001|2-Sided|95.0|-2.0|10.8|||Miettinen and Nurminen||Relebactam minus Placebo|Relebactam 125 mg - Placebo: Percentage Difference|
1662646|NCT01506271|3059245|Non-Inferiority|Non-inferiority test based on unconditional asymptotic Miettinen and Nurminen method without stratification.|Percentage Difference|1.1|||<|0.001|2-Sided|95.0|-6.2|8.6|||Miettinen and Nurminen||Relebactam minus Placebo|MK-7655 250 mg - Placebo: Percentage Difference|
1662647|NCT01506193|3059254|Non-Inferiority or Equivalence|Non-inferiority with respect to seroresponse for rSBA-MenC was concluded if the lower limit of the 95% CI around the difference in seroprotection rates between groups would be [–10%] or higher.|Difference in percentage|-1.02|||||2-Sided|95.0|-3.39|2.24||||||"Immune response for rSBA-MenC antibodies~Non-inferiority of Meningitec® conjugate vaccine co-administered with Priorix-Tetra™ compared to Meningitec® conjugate vaccine alone with respect to rabbit complement serum bactericidal assay (rSBA-MenC) antibody seroprotection rates (SPRs) at Day 42 after vaccination."|
1662648|NCT01506193|3059255|Non-Inferiority or Equivalence|Non-inferiority with respect to seroconversion rates for varicella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.|Difference in percentage|-0.33|||||2-Sided|95.0|-1.87|2.03||||||"Immune response for anti-varicella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-varicella seroconversion rates (SCRs) at Day 42 after dose 1."|
1662649|NCT01506193|3059255|Non-Inferiority or Equivalence|Non-inferiority with respect to seroconversion rates for rubella was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.|Difference in percentage|0.0|||||2-Sided|95.0|-1.23|2.29||||||"Immune response for anti-rubella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-rubella seroconversion rates (SCRs) at Day 42 after dose 1."|
1662650|NCT01506193|3059255|Non-Inferiority or Equivalence|Non-inferiority with respect to seroconversion rates for mumps was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.|Difference in percentage|1.29|||||2-Sided|95.0|-3.04|6.67||||||"Immune response for anti-mumps antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-mumps seroconversion rates (SCRs) at Day 42 after dose 1."|
1662651|NCT01506193|3059255|Non-Inferiority or Equivalence|Non-inferiority with respect to seroconversion rates for measles was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.|Difference in percentage|-0.04|||||2-Sided|95.0|-1.82|2.78||||||"Immune response for anti-measles antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-measles seroconversion rates (SCRs) at Day 42 after dose 1."|
1662652|NCT01505647|3059305|Superiority or Other||||||<|0.001||||||The threshold for statistical significance is 0.025 (1-sided). The P-value was not adjusted.|t-test, 1 sided|||The hypothesis tested was that ZOSTAVAX™ (AMP) induces an acceptable GMFR in VZV antibody titer from prevaccination to 6 weeks postvaccination|
1662695|NCT01505010|3059375|Superiority or Other (legacy)||Median Difference (Final Values)|1.7|Standard Error of the Mean|0.8||0.032|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1662653|NCT01505647|3059306|Non-Inferiority or Equivalence|The GMT induced by ZOSTAVAX™ (AMP) vaccine is statistically non-inferior to that induced by the current process vaccine if the lower bound of the 95% confidence interval of the GMT ratio is >0.67.|GMT Ratio|1.08|||<|0.001|2-Sided|95.0|0.98|1.2||The threshold for statistical significance is 0.025 (1-sided). The P-value was not adjusted.|Longitudinal regression model|The analyzed GMT ratio, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age and vaccination group||The hypothesis tested is that the GMT at Week 6 postvaccination with ZOSTAVAX™ (AMP) vaccine is non-inferior to that with the current process vaccine|
1662654|NCT01505634|3059313|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||2-Sided|95.0|-7.2|5.1|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Headache|
1662655|NCT01505634|3059313|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|3.1|||||2-Sided|95.0|-3.7|10.4|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Headache|
1662656|NCT01505634|3059313|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||2-Sided|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: White blood cells urine positive|
1662657|NCT01505634|3059313|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||2-Sided|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: White blood cells urine positive|
1662658|NCT01505634|3059313|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||2-Sided|95.0|-8.1|3.6|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Bacteriuria|
1662659|NCT01505634|3059313|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-3.0|||||2-Sided|95.0|-9.0|1.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Bacteriuria|
1662660|NCT01505634|3059313|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|2.1|||||2-Sided|95.0|-4.6|9.2|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Nausea|
1662661|NCT01505634|3059313|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||2-Sided|95.0|-6.4|6.5|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Nausea|
1662662|NCT01505634|3059313|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||2-Sided|95.0|-8.1|3.6|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Diarrhoea|
1662663|NCT01505634|3059313|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.1|||||2-Sided|95.0|-5.5|7.8|||||Relebactam minus Placebo|Percent Diff in Participants with AEs with Rate ≥4: Diarrhoea|
1662664|NCT01505634|3059314|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||2-Sided|95.0|-4.5|4.6|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to DR AEs|
1662665|NCT01505634|3059314|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.0|||||2-Sided|95.0|-3.6|6.2|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to DR AEs|
1662666|NCT01505634|3059315|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||2-Sided|95.0|-6.1|3.7|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to AEs|
1662667|NCT01505634|3059315|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.0|||||2-Sided|95.0|-4.4|6.8|||||Relebactam minus Placebo|Percent Diff in Participants with Discons Due to AEs|
1662668|NCT01505634|3059316|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.0|||||2-Sided|95.0|-5.5|2.8|||||Relebactam minus Placebo|Percent Diff in Participants with DR SAEs|
1662669|NCT01505634|3059316|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||2-Sided|95.0|-4.5|4.6|||||Relebactam minus Placebo|Percent Diff in Participants with DR SAEs|
1662670|NCT01505634|3059317|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.1|||||2-Sided|95.0|-8.4|8.6|||||Relebactam minus Placebo|Percent Diff in Participants with DR AEs|
1662671|NCT01505634|3059317|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|1.1|||||2-Sided|95.0|-7.5|9.8|||||Relebactam minus Placebo|Percent Diff in Participants with DR AEs|
1662672|NCT01505634|3059318|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-2.0|||||2-Sided|95.0|-7.6|2.8|||||Relebactam minus Placebo|Percent Diff in Participants with SAEs|
1662673|NCT01505634|3059318|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|0.0|||||2-Sided|95.0|-5.8|5.9|||||Relebactam minus Placebo|Percent Diff in Participants with SAEs|
1662674|NCT01505634|3059319|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-0.7|||||2-Sided|95.0|-13.4|12.0|||||Relebactam minus Placebo|Percent Diff in Participants with AEs|
1662675|NCT01505634|3059319|Other|Difference in percentage and 95% CI are based on unconditional and asymptotic Miettinen and Nurminen method.|Percent Difference|-1.7||||||95.0|-14.3|10.9|||||Relebactam minus Placebo|Percent Diff in Participants with AEs|
1662696|NCT01505010|3059375|Superiority||Median Difference (Final Values)|1.7||||0.032|2-Sided||||||Wilcoxon (Mann-Whitney)|||Wilcocon rank sum test|
1662697|NCT01505010|3059376|Superiority or Other (legacy)||Mean Difference (Net)|2.5|Standard Error of the Mean|4.87||0.86|2-Sided||||||t-test, 2 sided|||Difference between control and intervention group at 6 months|
1662676|NCT01505634|3059320|Other|Event of Clinical Interest (ECI) #2 is elevated AST or ALT ≥3X ULN, elevated total bilirubin ≥2X ULN, and with an ALP <2X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|0.0|||>|0.999|2-Sided|95.0|-3.7|3.8||No participants met the criteria for ECI #2.|Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with ECI #2|
1662677|NCT01505634|3059320|Other|Event of Clinical Interest (ECI) #2 is elevated AST or ALT ≥3X ULN, elevated total bilirubin ≥2X ULN, and with an ALP <2X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|0.0|||>|0.999|2-Sided|95.0|-3.7|3.8||No participants met the criteria for ECI #2.|Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff Participants with ECI #2|
1662678|NCT01505634|3059321|Other|ECI #1 is a confirmed elevated AST or ALT ≥5X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|1.0||||0.315|2-Sided|95.0|-2.7|5.5|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with ECI #1|
1662679|NCT01505634|3059321|Other|ECI #1 is a confirmed elevated AST or ALT ≥5X ULN. Inferential testing for statistical significance with p-values and 95% confidence intervals was performed to provide a comparison between the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group.|Percent Difference|1.0||||0.315|2-Sided|95.0|-2.7|5.5|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Participants with Event of Clinical Interest (ECI) #1|
1662680|NCT01505634|3059322|Non-Inferiority|Non-inferiority for the relebactam 125 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group was demonstrated if the lower bound of the 95% CI was not lower than the pre-specified non-inferiority margin of -15%.|Percent Difference|-0.1|||<|0.001|2-Sided|95.0|-6.4|5.9|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Diff in Favorable MR|
1662681|NCT01505634|3059322|Non-Inferiority|Non-inferiority for the relebactam 250 mg + imipenem/cilastatin group versus the Placebo for relebactam + imipenem/cilastatin group was demonstrated if the lower bound of the 95% CI was not lower than the pre-specified non-inferiority margin of -15%.|Percent Difference|-3.1|||<|0.005|2-Sided|95.0|-11.2|3.2|||Miettinen and Nurminen||Relebactam minus Placebo|Percent Difference (Diff) in Favorable MR|
1662682|NCT01505491|3059343|Equivalence|p−value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|96.53|Standard Error of the Mean|1.064||0.0016|2-Sided|90.0|87.064|107.017|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.|
1662683|NCT01505491|3059343|Equivalence|p−value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|117.53|Standard Error of the Mean|1.066||0.17|2-Sided|90.0|105.638|130.757|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.|
1662684|NCT01505491|3059343|Equivalence|p−value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|110.3|Standard Error of the Mean|1.063||0.0212|2-Sided|90.0|99.687|122.035|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.|
1662685|NCT01505491|3059344|Equivalence|p−value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|86.24|Standard Error of the Mean|1.077||0.1572|2-Sided|90.0|76.238|97.564|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.|
1662686|NCT01505491|3059344|Equivalence|p−value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|128.88|Standard Error of the Mean|1.08||0.6547|2-Sided|90.0|113.492|146.365|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.|
1662687|NCT01505491|3059344|Equivalence|p−value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|109.42|Standard Error of the Mean|1.073||0.0303|2-Sided|90.0|97.384|122.935|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.|
1662688|NCT01505491|3059345|Equivalence|p−value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|86.51|Standard Error of the Mean|1.09||0.1833|2-Sided|90.0|74.974|99.83|||ANOVA||Bio-equivalence of Humira EU vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.|
1662689|NCT01505491|3059345|Equivalence|p−value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|132.24|Standard Error of the Mean|1.094||0.7345|2-Sided|90.0|113.984|153.412|||ANOVA||Bio-equivalence of BI 695501 vs. Humira EU was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.|
1662690|NCT01505491|3059345|Equivalence|p−value for ratio outside interval 80% to 125%|Geometric mean ratio (%)|113.22|Standard Error of the Mean|1.086||0.1163|2-Sided|90.0|98.752|129.812|||ANOVA||Bio-equivalence of BI 695501 vs. Humira US was estimated by the ratios of the adjusted geometric means (gMean). Standard error of the mean is actually geometric standard error.|ANOVA (analysis of variance) model on the logarithm scale was used with 'treatment' and 'age' as fixed effect.|
1662698|NCT01505010|3059377|Superiority||Mean Difference (Final Values)|22.4|Standard Error of the Mean|8.5||0.018|2-Sided||||||Mixed Models Analysis|Adjusted for the baseline 24-h systolic blood pressure|Difference at 6 months in 24-h systolic blood pressure (control minus intervention)|We used mixed models to compare blood pressure changes between randomized groups at 6 months, while adjusting for the baseline blood pressure; statistical significance was a P-value less than 0.05 on two-sided tests.|
1662699|NCT01504867|3059390|Superiority or Other|||||||0.79|||||||Wilcoxon (Mann-Whitney)||||
1662700|NCT01504867|3059391|Superiority or Other|||||||0.08|||||||Chi-squared||||
1662701|NCT01504867|3059392|Superiority or Other|||||||0.72|||||||Wilcoxon (Mann-Whitney)||||
1662702|NCT01504867|3059393|Superiority or Other|||||||0.23|||||||Chi-squared||||
1662703|NCT01504867|3059394|Superiority or Other|||||||0.36|||||||Chi-squared||||
1662704|NCT01504867|3059395|Superiority or Other||||||>|0.99|||||||Chi-squared||||
1662705|NCT01504867|3059396|Superiority or Other|||||||0.53|||||||Wald|This was a large sample (Wald) test estimated using a conditional logistic regression model with site as a stratification variable.||The primary outcome significance level was adjusted for multiple testing associated with the interim analysis. Its significance level is 92.6%|
1662706|NCT01504841|3059402|Other||%|50.0|||||2-Sided|95.0|6.8|93.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants with a >5% decline in absolute CD4 %.|Week 48 time point.|
1662707|NCT01504841|3059402|Other||%|18.2|||||2-Sided|95.0|2.3|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants with a >5% decline in absolute CD4 %.|Week 48 time point.|
1662708|NCT01504841|3059402|Other||%|25.0|||||2-Sided|95.0|0.6|80.6|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants with a >5% decline in absolute CD4 %.|Week 24 time point.|
1662709|NCT01504841|3059402|Other||%|9.1|||||2-Sided|95.0|0.2|41.3|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants with a >5% decline in absolute CD4 %.|Week 24 time point.|
1662710|NCT01504841|3059402|Other||%|50.0|||||2-Sided|95.0|6.8|93.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 12, percentage of participants with a >5% decline in absolute CD4 %.|Week 12 time point.|
1662711|NCT01504841|3059402|Other||%|9.1|||||2-Sided|95.0|0.2|41.3|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 12, percentage of participants with a >5% decline in absolute CD4 %.|Week 12 time point.|
1662712|NCT01504841|3059406|Other||%|75.0|||||2-Sided|95.0|19.4|99.4|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 48, percentage of participants who experienced Virologic Failure.|Week 48 time point.|
1662713|NCT01504841|3059406|Other||%|27.3|||||2-Sided|95.0|6.0|61.0|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 48, percentage of participants who experienced Virologic Failure.|Week 48 time point.|
1662714|NCT01504841|3059406|Other||%|25.0|||||2-Sided|95.0|0.6|80.6|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II Week 24, percentage of participants who experienced Virologic Failure.|Week 24 time point.|
1662715|NCT01504841|3059406|Other||%|18.2|||||2-Sided|95.0|2.3|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I Week 24, percentage of participants who experienced Virologic Failure.|Week 24 time point.|
1662716|NCT01504841|3059407|Other||%|0.0|||||2-Sided|95.0|0.0|60.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE at least possibly related to study medication.||
1662717|NCT01504841|3059407|Other||%|18.2|||||2-Sided|95.0|2.5|51.8|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE at least possibly related to study medications.||
1662718|NCT01504841|3059410|Other||%|100.0|||||2-Sided|95.0|39.8|100.0|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort II, percentage of participants who experienced a grade 3+ AE.||
1662719|NCT01504841|3059410|Other||%|36.4|||||2-Sided|95.0|10.9|69.2|||||Exact Binomial (Clopper-Pearson) confidence intervals for Cohort I, percentage of participants who experienced a grade 3+ AE.||
1662720|NCT01504412|3059417|Superiority||Least squares mean difference|-7.4||||0.0093|2-Sided|95.0|-13.0|-1.8|||ANCOVA|||This analysis assessed placebo vs DS-5565 30 mg/day for the visual analog scale.|
1662721|NCT01504412|3059417|Superiority||Least squares mean difference|-5.4||||0.0577|2-Sided|95.0|-10.9|0.2|||ANCOVA|||This analysis assessed placebo vs DS-5565 20 mg/day for the visual analog scale.|
1662722|NCT01504412|3059417|Superiority||Least squares mean difference|-5.2||||0.0691|2-Sided|95.0|-10.8|0.4|||ANCOVA|||This analysis assessed placebo vs DS-5565 10 mg/day for the visual analog scale.|
1662723|NCT01504412|3059418|Superiority||Hazard Ratio (HR)|-0.3||||0.4704|2-Sided|95.0|-0.87|0.27||Dunnett method was used for adjustment of multiple testing.|ANCOVA||||
1662724|NCT01504412|3059418|Superiority||Hazard Ratio (HR)|-0.37||||0.2886|2-Sided|95.0|-0.93|0.2||Dunnett method was used for adjustment of multiple testing.|ANCOVA||||
1662725|NCT01504412|3059418|Superiority||Hazard Ratio (HR)|-0.42||||0.1995|2-Sided|95.0|-0.99|0.15||Dunnett method was used for adjustment of multiple testing.|ANCOVA||||
1662726|NCT01503749|3059422|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1662727|NCT01503333|3059424|Other||parameter estimate|3.19|||||2-Sided|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar|
1662728|NCT01503333|3059425|Other||parameter estimate|24.48|||<|0.001|2-Sided||||||Path analysis|||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar|
1662885|NCT01499810|3059762|Superiority or Other||||||<|0.0001||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662905|NCT01499355|3059795|Superiority or Other|||||||0.907|||||||ANCOVA||||
1662729|NCT01503333|3059426|Other||parameter estimate|30.48|||<|0.001|2-Sided||||||Path analysis|||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar|
1662730|NCT01503333|3059427|Other||parameter estimate|0.47|||||2-Sided|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar|
1662731|NCT01503333|3059428|Other||parameter estimate|2.9|||||2-Sided|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-squar|
1662732|NCT01503333|3059429|Other||parameter estimate|-0.97|||||2-Sided|||||||||Path analysis was performed to examine study mediation model. Maximum likelihood estimates were computed. Model fit was evaluated based on fit indices: (a) Goodness-of-Fit Index (GFI) ≥.95, (b) Comparative Fit Index (CFI) ≥.95, (c) Root Mean Square Error of Approximation (RMSEA) ≤.05; (d) standardized root mean squared residual (SRMR) ≤.08; and (e) chi-square test p>.05.26.|
1662733|NCT01503333|3059430|Equivalence|Linear mixed-effect models were applied to examine the intervention effect on MVPA at 9-month follow up. Models included the group variable, cluster random effect of school, and the following fixed effects: age, BMI z-score, race, SES, ethnicity, pubertal stage, and study year. Baseline MVPA was included when evaluating the intervention effect at follow up.|parameter estimate|-0.09||||0.118|2-Sided|95.0|-0.21|0.02|||Mixed Models Analysis||||
1662734|NCT01503333|3059431|Equivalence|Linear mixed models were used to analyze intervention effect on % body fat according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline % body fat, age, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and year cohort.|parameter estimate|-0.37|Standard Error of the Mean|0.14||0.007|2-Sided|95.0|-0.64|-0.1|||Mixed Models Analysis|||Immediately post-intervention, percent body fat will be significantly lower among girls in the intervention than control schools.|
1662735|NCT01503333|3059432|Other|Linear mixed models were used to analyze intervention effect on BMI-z according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models for BMI-z included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline BMI-z, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and study year cohort.|parameter estimate|-0.02|Standard Error of the Mean|0.01||0.191|2-Sided|95.0|-0.05|0.01|||Mixed Models Analysis|||Immediately post-intervention, BMI z-score will be significantly lower among girls in the intervention than control schools.|
1662736|NCT01503333|3059433|Equivalence|Linear mixed models were used to analyze intervention effect on CV fitness according to intention-to-treat, with school pairs treated as random effect and students nested within school and treatment condition. Models included main intervention predictor (control or intervention), incorporated cluster random effect, specified school pairs (random intercept), and controlled for baseline CV fitness, physical activity, race, socioeconomic status, ethnicity, pubertal stage, and study year cohort.|parameter estimate|0.2|Standard Error of the Mean|0.08||0.018|2-Sided|95.0|0.03|0.36|||Mixed Models Analysis|||Immediately post-intervention, cardiovascular (CV) fitness will be higher among girls in the intervention than control schools.|
1662737|NCT01503333|3059434|Equivalence|Linear mixed-effect models were applied to examine the intervention effect on MVPA at post-intervention. Models included the group variable, cluster random effect of school, and the following fixed effects: age, BMI z-score, race, SES, ethnicity, pubertal stage, and study year. Baseline MVPA was included when evaluating the intervention effect at post-intervention.|parameter estimate|-0.08||||0.207|2-Sided|95.0|-0.21|0.05|||Mixed Models Analysis|||Hypotheses: Post-intervention, weighted mean minutes of MVPA/week will be greater by 16 minutes among girls in intervention than control schools. Mean minutes per week is determined by multiplying mean minutes/hour by 90 hours that girls are awake in a week (10 hours awake on each weekend day; 14 hours awake on each weekday).|
1662738|NCT01502644|3059483|Other||Mean Difference (Net)|18.0||||0.01|2-Sided|95.0|3.7|32.2|||Linear Mixed Modeling|Group, group×week, average baseline pain, and opioid use at baseline were entered as fixed effects using an autoregressive covariance structure.|||
1662739|NCT01502371|3059497|Superiority or Other||Mean Difference (Net)|1.39||||0.368|2-Sided|95.0|-1.65|4.44||cLDA model method proposed by Liang & Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction & region (North America, Latin America & the European Union)|cLDA model|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 50 mcg BID vs. MF DPI 100 mcg QD. Only participants who received MF MDI 50 mcg BID or MF DPI 100 mcg QD were included in the statistical analysis.|
1662740|NCT01502371|3059498|Superiority or Other||Mean Difference (Net)|0.18||||0.045|2-Sided|95.0|0.0|0.36||cLDA model method proposed by Liang & Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction & region (North America, Latin America & the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 200 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.|
1662741|NCT01502371|3059498|Superiority or Other||Mean Difference (Net)|0.12||||0.178|2-Sided|95.0|-0.06|0.3||cLDA model method proposed by Liang & Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction & region (North America, Latin America & the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 100 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.|
1662886|NCT01499810|3059763|Superiority or Other||||||<|0.0001||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662887|NCT01499810|3059765|Superiority or Other||||||<|0.0001||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662742|NCT01502371|3059498|Superiority or Other||Mean Difference (Net)|0.1||||0.28|2-Sided|95.0|-0.08|0.27||cLDA model method proposed by Liang & Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction & region (North America, Latin America & the European Union)|cLDA|||Change from Baseline in PAQLQ(S) Total Score: MF MDI 50 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.|
1662743|NCT01502371|3059499|Superiority or Other||Mean Difference (Net)|18.01||||0.057|2-Sided|95.0|-0.51|36.53||cLDA model method proposed by Liang & Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction & region (North America, Latin America & the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 200 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.|
1662744|NCT01502371|3059499|Superiority or Other||Mean Difference (Net)|27.35||||0.004|2-Sided|95.0|8.63|46.08||cLDA model method proposed by Liang & Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction & region (North America, Latin America & the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 100 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.|
1662745|NCT01502371|3059499|Superiority or Other||Mean Difference (Net)|19.15||||0.045|2-Sided|95.0|0.43|37.87||cLDA model method proposed by Liang & Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction & region (North America, Latin America & the European Union)|cLDA|||Change from Baseline in AM PEF: MF MDI 50 mcg BID vs. Placebo. Only participants who received MF MDI or Placebo were included in the statistical analysis.|
1662746|NCT01502371|3059500|Superiority or Other||Mean Difference (Net)|5.34||||0.001|2-Sided|95.0|2.07|8.61||cLDA model method proposed by Liang & Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction & region (North America, Latin America & the European Union)|cLDA|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 200 mcg BID vs. Placebo|
1662747|NCT01502371|3059500|Superiority or Other||Mean Difference (Net)|6.29|||<|0.001|2-Sided|95.0|3.05|9.53||cLDA model method proposed by Liang & Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction & region (North America, Latin America & the European Union)|cLDA|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 100 mcg BID vs. Placebo|
1662748|NCT01502371|3059500|Superiority or Other||Mean Difference (Net)|3.87|||<|0.019|2-Sided|95.0|0.64|7.09||Constrained longitudinal data analysis (cLDA) model method proposed by Liang & Zeger includes terms for treatment, time in weeks, age strata (age 5-6, 7-11), treatment by time interaction & region (North America, Latin America & the European Union)|cLDA model|||Change from Baseline in percent predicted FEV1 at Week 12: MF MDI 50 mcg BID vs. Placebo|
1662749|NCT01502332|3059501|Superiority or Other|||||||0.267|||||||Regression, Logistic||||
1662750|NCT01502332|3059503|Superiority or Other|||||||0.037|||||||Log Rank||||
1662751|NCT01502332|3059504|Superiority or Other|||||||0.014|||||||Log Rank||||
1662752|NCT01502332|3059505|Superiority or Other|||||||0.016|||||||Wilcoxon (Mann-Whitney)||||
1662753|NCT01500720|3059559|Superiority or Other||Cox Proportional Hazard|2.169|||<|0.0001|2-Sided|95.0|1.563|3.01||P-value was calculated from stratified two-sided log-rank test, stratifying for brain metastases and lactate dehydrogenase (LDH) level at the time of randomization.|Stratified Two-Sided Log-Rank Test||Hazard ratio was estimated using a COX Proportional Hazards regression model, stratifying for brain metastases and LDH level at the time of randomization.||
1662754|NCT01500629|3059570|Superiority or Other||Mean Difference (Final Values)|0.24||||0.546|2-Sided|95.0|-0.57|1.04|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662755|NCT01500629|3059571|Superiority or Other||Mean Difference (Final Values)|0.02||||0.961|2-Sided|95.0|-0.85|0.89|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662756|NCT01500629|3059572|Superiority or Other||Mean Difference (Final Values)|0.27||||0.481|2-Sided|95.0|-0.51|1.04|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662757|NCT01500629|3059573|Superiority or Other||Mean Difference (Final Values)|-0.46||||0.261|2-Sided|95.0|-1.3|0.38|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662758|NCT01500629|3059578|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.651|2-Sided|95.0|-0.3|0.19|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662759|NCT01500629|3059579|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.947|2-Sided|95.0|-0.36|0.34|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662888|NCT01499654|3059776|Superiority or Other|||||||0.44|||||||Wilcoxon (Mann-Whitney)||||
1662889|NCT01499654|3059776|Superiority or Other|||||||0.006|||||||Wilcoxon (Mann-Whitney)||||
1662760|NCT01500629|3059580|Superiority or Other||Mean Difference (Final Values)|0.1||||0.35|2-Sided|95.0|-0.11|0.3|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662761|NCT01500629|3059581|Superiority or Other||Mean Difference (Final Values)|0.12||||0.376|2-Sided|95.0|-0.15|0.39|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662762|NCT01500629|3059582|Superiority or Other||Mean Difference (Final Values)|0.14||||0.521|2-Sided|95.0|-0.31|0.59|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662763|NCT01500629|3059583|Superiority or Other||Mean Difference (Final Values)|0.0||||0.972|2-Sided|95.0|-0.29|0.28|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662764|NCT01500629|3059584|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.666|2-Sided|95.0|-0.28|0.18|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662765|NCT01500629|3059585|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.907|2-Sided|95.0|-0.24|0.22|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662766|NCT01500629|3059586|Superiority or Other||Median Difference (Final Values)|0.5||||0.014||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662767|NCT01500629|3059587|Superiority or Other||Median Difference (Final Values)|0.5||||0.072||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662768|NCT01500629|3059588|Superiority or Other||Median Difference (Final Values)|0.5||||0.206|||||||Wilcoxon (Mann-Whitney)|The rank sum test was based on period difference for comparison between sequence.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662769|NCT01500629|3059589|Superiority or Other||Median Difference (Final Values)|0.3||||0.175||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662770|NCT01500629|3059590|Superiority or Other||Median Difference (Final Values)|0.0||||0.803||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662771|NCT01500629|3059591|Superiority or Other||Median Difference (Final Values)|0.0||||0.619||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662772|NCT01500629|3059592|Superiority or Other||Median Difference (Final Values)|0.0||||0.845||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662773|NCT01500629|3059593|Superiority or Other||Median Difference (Final Values)|-0.8||||0.034||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662774|NCT01500629|3059594|Superiority or Other||Median Difference (Final Values)|0.0||||0.314||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662775|NCT01500629|3059595|Superiority or Other||Median Difference (Final Values)|-0.3||||0.689||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662776|NCT01500629|3059596|Superiority or Other||Median Difference (Final Values)|0.0||||0.121||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662777|NCT01500629|3059597|Superiority or Other||Median Difference (Final Values)|-0.5||||0.903||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662778|NCT01500629|3059598|Superiority or Other||Median Difference (Final Values)|0.0||||0.307||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662779|NCT01500629|3059599|Superiority or Other||Median Difference (Final Values)|-1.0||||0.042||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662780|NCT01500629|3059600|Superiority or Other||Median Difference (Final Values)|0.0||||0.092||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662781|NCT01500629|3059601|Superiority or Other||Median Difference (Final Values)|0.0||||0.409||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662782|NCT01500629|3059602|Superiority or Other||Median Difference (Final Values)|0.0||||0.287||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662783|NCT01500629|3059603|Superiority or Other||Median Difference (Final Values)|-1.0||||0.253||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662784|NCT01500629|3059604|Superiority or Other||Median Difference (Final Values)|0.0||||0.108||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662785|NCT01500629|3059605|Superiority or Other||Median Difference (Final Values)|0.0||||0.701||||||The rank sum test was based on period difference for comparison between sequence.|Wilcoxon (Mann-Whitney)|||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662786|NCT01500629|3059606|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.899|2-Sided|95.0|-1.21|1.07|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662787|NCT01500629|3059607|Superiority or Other||Mean Difference (Final Values)|-0.72||||0.291|2-Sided|95.0|-2.12|0.67|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662788|NCT01500629|3059608|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.625|2-Sided|95.0|-1.49|0.92|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662789|NCT01500629|3059609|Superiority or Other||Mean Difference (Final Values)|-0.79||||0.156|2-Sided|95.0|-1.9|0.33|||Mixed Models Analysis|Treatment, period and sequence as fixed effects and subject as a random effect.||The following comparison was made: Allergen Block (C-1266-7) vs placebo. For this comparison, the following hypothesis was tested: Ho: µ1= µ2 against the two-sided alternative H1: µ1≠ µ2 where µ1 and µ2 are the mean values of the parameter variable for the two treatment groups.|
1662790|NCT01500434|3059635|Non-Inferiority or Equivalence|Study had 85% statistical power to demonstrate that the 12-month rate for TLF (accounting for an expected 1-year attrition rate of 5%) is less than the performance goal, assuming a 1-year TLF rate of 9.0%.|Target Lesion Failure Rate|3.2|||<|0.0001|1-Sided|95.0||7.96|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the primary endpoint rate in the PROMUS Element cohort is less than the predefined performance goal of 19.4%.|
1662791|NCT01500278|3059652|Superiority or Other||Odds Ratio (OR)|1.09|||=|0|2-Sided|95.0|0.82|1.45||The odds ratio, CI and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (<2 years or >=2 years), and geographic region as factors and Baseline DAS28(ESR) and age as covariates.|Regression, Logistic||||
1662792|NCT01500278|3059653|Superiority or Other||Odds Ratio (OR)|0.9|||=|0|2-Sided|95.0|0.67|1.2||The odds ratio, CI, and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (<2 years or >=2 years), and geographic region as factors and age as a covariate.|Regression, Logistic||||
1662793|NCT01500252|3059654|Superiority or Other|||||||0.31|||||||Chi-squared||||
1662794|NCT01500252|3059655|Superiority or Other|||||||0.35|||||||t-test, 2 sided||||
1662795|NCT01500252|3059656|Superiority or Other|||||||0.98|||||||t-test, 2 sided||||
1662796|NCT01500252|3059657|Superiority or Other|||||||0.71|||||||t-test, 2 sided||||
1662797|NCT01500252|3059658|Superiority or Other|||||||0.43|||||||t-test, 2 sided||||
1662798|NCT01500252|3059659|Superiority or Other|||||||0.39|||||||t-test, 2 sided||||
1662799|NCT01500252|3059660|Superiority or Other|||||||0.1|||||||t-test, 2 sided||||
1662800|NCT01500252|3059662|Superiority or Other|||||||0.83|||||||t-test, 2 sided||||
1662801|NCT01500252|3059663|Superiority or Other|||||||0.59|||||||t-test, 2 sided||||
1662802|NCT01500226|3059664|Superiority or Other||Odds Ratio (OR)|1.6|||<|0.001|2-Sided|95.0|1.3|2.0||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.|||
1662803|NCT01500226|3059665|Superiority or Other||Odds Ratio (OR)|1.2||||0.143|2-Sided|95.0|0.9|1.6||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.|||
1662804|NCT01500226|3059666|Superiority or Other||Odds Ratio (OR)|1.6|||<|0.001|2-Sided|95.0|1.2|2.0||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.|||
1662805|NCT01500213|3059667|Superiority or Other||Odds Ratio (OR)|1.4||||0.084|2-Sided|95.0|1.0|1.9||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.|||
1662806|NCT01500213|3059668|Superiority or Other||Odds Ratio (OR)|1.3||||0.233|2-Sided|95.0|0.8|2.0||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.|||
1662807|NCT01500213|3059669|Superiority or Other||Odds Ratio (OR)|1.4||||0.043|2-Sided|95.0|1.0|2.1||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.|||
1662808|NCT01500200|3059673|Superiority|||||||0.699||||||Hypothesis tests were two-sided with an alpha of 0.05.|Mixed Models Analysis|ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.||Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified weights (0.6/0.4 for Stage 1/Stage 2). Within each stage ALKS 5461 8mg/8mg was compared to placebo (i.e., ALKS 5461 8mg/8mg S1 vs Placebo S1; and ALKS 5461 8mg/8mg S2 vs Placebo S2.|
1662809|NCT01500200|3059673|Superiority|||||||0.014||||||Hypothesis tests were two-sided with an alpha of 0.5.|Mixed Models Analysis|ALKS 5461 was compared to PBO using stage-specific MMRM for change from Baseline. Model-derived estimates were combined using pre-specified weights.||Analysis was conducted for each stage separately and overall efficacy was based on combined stage analysis where stage-specific estimates were combined using pre-specified weights (0.6/0.4 for Stage 1/Stage 2). Within each stage ALKS 5461 2mg/2mg was compared to placebo (i.e., ALKS 5461 2mg/2mg S1 vs Placebo S1; and ALKS 5461 2mg/2mg S2 vs Placebo S2.|
1662810|NCT01500187|3059674|Superiority or Other|||||||0.423|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at six months|
1662811|NCT01500187|3059674|Superiority or Other|||||||0.001|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at three months|
1662812|NCT01500187|3059674|Superiority or Other|||||||0.636|||||||ANOVA|||Null Hypothesis: there is no intergroup difference (α=0.05) in DIAGNOdent reading at baseline|
1662813|NCT01500135|3059675|Superiority or Other||Hazard Ratio (HR)|1.14|Standard Error of the Mean|0.24||0.684|2-Sided|95.0|0.7|1.8||P-value was adjusted using Hochberg's adjustment for multiplicity.|Proportional Hazard Model||||
1662814|NCT01500135|3059676|Superiority or Other||Odds Ratio (OR)|0.85|Standard Error of the Mean|0.33||0.684|2-Sided|95.0|0.4|1.82||Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.|Regression, Logistic||||
1662890|NCT01499654|3059777|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1662891|NCT01499654|3059777|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1662815|NCT01500135|3059677|Superiority or Other||Odds Ratio (OR)|1.62|Standard Error of the Mean|0.72||0.276|2-Sided|95.0|0.68|3.88||Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.|Regression, Logistic||||
1662816|NCT01500096|3059681|Superiority|||||||0.41|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662817|NCT01500096|3059681|Superiority|||||||0.47|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662818|NCT01500096|3059682|Superiority|||||||0.19|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662819|NCT01500096|3059682|Superiority|||||||0.18|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662820|NCT01500096|3059683|Superiority|||||||0.71|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662821|NCT01500096|3059683|Superiority|||||||0.31|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 5 are significantly different between arms.|
1662822|NCT01500096|3059684|Superiority|||||||0.58|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.|
1662823|NCT01500096|3059684|Superiority|||||||0.34|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.|
1662824|NCT01500096|3059684|Superiority|||||||0.72|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.|
1662825|NCT01500096|3059684|Superiority|||||||0.41|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.|
1662826|NCT01500096|3059684|Superiority|||||||0.28|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.|
1662827|NCT01500096|3059684|Superiority|||||||0.6|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.|
1662828|NCT01500096|3059685|Superiority|||||||0.2898|||||||Wilcoxon (Mann-Whitney)|2 sides Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662829|NCT01500096|3059685|Superiority|||||||0.9885|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662830|NCT01500096|3059686|Superiority|||||||0.5532|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662831|NCT01500096|3059686|Superiority|||||||0.7884|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662832|NCT01500096|3059687|Superiority|||||||0.51|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662833|NCT01500096|3059687|Superiority|||||||0.17|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662834|NCT01500096|3059688|Superiority|||||||0.0579|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662835|NCT01500096|3059688|Superiority|||||||0.6818|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662836|NCT01500096|3059689|Superiority|||||||0.7391|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662837|NCT01500096|3059689|Superiority|||||||0.7454|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662838|NCT01500096|3059690|Superiority|||||||0.1191|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662839|NCT01500096|3059690|Superiority|||||||0.1329|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662840|NCT01500096|3059691|Superiority|||||||0.73|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms|
1662841|NCT01500096|3059691|Superiority|||||||0.15|||||||Wilcoxon (Mann-Whitney)|2 sided Wilcoxon (Mann-Whitney)||Testing whether the changes from baseline to week 4 are significantly different between arms.|
1662842|NCT01499849|3059713|Superiority or Other||Odds Ratio (OR)|1.8||||0.001|2-Sided|95.0|1.3|2.6||To control for multiplicity, analyses were performed hierarchically. CR overall was tested only if both CR delayed and CR acute were statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.|||
1662843|NCT01499849|3059714|Superiority or Other||Odds Ratio (OR)|1.8||||0.005|2-Sided|95.0|1.2|2.8||To control for multiplicity, analyses were performed hierarchically. CR-acute was tested only if the result for the primary endpoint, CR delayed, was statistically significant.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.|||
1662892|NCT01499654|3059778|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1662893|NCT01499654|3059778|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1662894|NCT01499654|3059779|Superiority or Other|||||||0.67|||||||Wilcoxon (Mann-Whitney)||||
1662844|NCT01499849|3059715|Superiority or Other||Odds Ratio (OR)|1.9|||<|0.001|2-Sided|95.0|1.3|2.7||To control for multiplicity, analyses were performed hierarchically. For the CR delayed the threshold for statistical significance was 0.05; no further adjustment for multiplicity were required for the primary endpoint.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test was stratified by sex. Missing data were imputed as treatment failures.|||
1662845|NCT01499810|3059722|Superiority or Other|||||||0.014||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662846|NCT01499810|3059723|Superiority or Other|||||||0.17||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662847|NCT01499810|3059724|Superiority or Other|||||||0.4||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662848|NCT01499810|3059725|Superiority or Other|||||||0.32||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662849|NCT01499810|3059726|Superiority or Other|||||||0.92||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662850|NCT01499810|3059727|Superiority or Other|||||||0.35||||||Repeated measures analysis|t-test, 2 sided|||Repeated measures analysis|
1662851|NCT01499810|3059728|Superiority or Other|||||||0.76||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662852|NCT01499810|3059729|Superiority or Other|||||||0.65||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662853|NCT01499810|3059730|Superiority or Other|||||||0.89||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662854|NCT01499810|3059731|Superiority or Other|||||||0.29||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662855|NCT01499810|3059732|Superiority or Other|||||||0.22||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662856|NCT01499810|3059733|Superiority or Other|||||||0.35||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662857|NCT01499810|3059734|Superiority or Other|||||||0.08||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662858|NCT01499810|3059735|Superiority or Other|||||||0.76||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662859|NCT01499810|3059736|Superiority or Other|||||||0.99||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662860|NCT01499810|3059737|Superiority or Other|||||||0.37||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662861|NCT01499810|3059738|Superiority or Other|||||||0.72||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662862|NCT01499810|3059739|Superiority or Other|||||||0.12||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662863|NCT01499810|3059740|Superiority or Other|||||||0.32||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662864|NCT01499810|3059741|Superiority or Other|||||||0.07||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662865|NCT01499810|3059742|Superiority or Other|||||||0.06||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662866|NCT01499810|3059743|Superiority or Other|||||||0.77||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662867|NCT01499810|3059744|Superiority or Other|||||||0.87||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662868|NCT01499810|3059745|Superiority or Other|||||||0.54||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662869|NCT01499810|3059746|Superiority or Other|||||||0.57||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662870|NCT01499810|3059747|Superiority or Other|||||||0.0002||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662871|NCT01499810|3059748|Superiority or Other|||||||0.0004||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662872|NCT01499810|3059749|Superiority or Other|||||||0.001||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662873|NCT01499810|3059750|Superiority or Other|||||||0.0007||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662874|NCT01499810|3059751|Superiority or Other|||||||0.0001||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662875|NCT01499810|3059752|Superiority or Other|||||||4e-05||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662876|NCT01499810|3059753|Superiority or Other|||||||9e-05||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662877|NCT01499810|3059754|Superiority or Other|||||||7e-05||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662878|NCT01499810|3059755|Superiority or Other|||||||0.12||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662879|NCT01499810|3059756|Superiority or Other|||||||0.35||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662880|NCT01499810|3059757|Superiority or Other||||||<|0.0001||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662881|NCT01499810|3059758|Superiority or Other|||||||0.0001||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662882|NCT01499810|3059759|Superiority or Other||||||<|0.0001||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662883|NCT01499810|3059760|Superiority or Other||||||<|0.0001||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662884|NCT01499810|3059761|Superiority or Other||||||<|0.0001||||||threshold for statistical significance p<0.05|t-test, 2 sided|||Repeated measures analysis|
1662895|NCT01499654|3059779|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1662906|NCT01499355|3059795|Superiority or Other|||||||0.769|||||||Regression, Cox||||
1662907|NCT01499355|3059795|Superiority or Other|||||||0.863|||||||Regression, Cox||||
1662908|NCT01499355|3059798|Superiority or Other|||||||0.2876|||||||Cochran-Mantel-Haenszel||||
1662909|NCT01499355|3059798|Superiority or Other|||||||0.0252|||||||Cochran-Mantel-Haenszel||||
1662910|NCT01499355|3059798|Superiority or Other||Odds Ratio (OR)|0.4344||||0.5455|2-Sided|90.0|0.0996|1.8941||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Regression, Logistic||||
1662911|NCT01499355|3059798|Superiority or Other||Odds Ratio (OR)|0.0628||||0.0456|2-Sided|90.0|0.0081|0.4843||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Regression, Logistic||||
1662912|NCT01499355|3059799|Superiority or Other|||||||0.0668||||||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cochran-Mantel-Haenszel||||
1662913|NCT01499355|3059799|Superiority or Other|||||||0.0486||||||Model includes the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cochran-Mantel-Haenszel||||
1662914|NCT01499355|3059800|Superiority or Other|||||||0.283||||||P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, ROW) and renal response at Run-in Week 12 (partial and non-response).|Cox proportional hazard||||
1662915|NCT01499355|3059800|Superiority or Other|||||||0.367||||||P-Value from Cox proportional hazard model, including the variable for treatment, adjusted for the covariates including region (Latin America, Asia, rest of world [ROW]) and renal response at Run-in Week 12 (partial and non-response).|Cox proportional hazard||||
1662916|NCT01499290|3059815|Non-Inferiority or Equivalence|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-0.8|||||2-Sided|95.0|-4.61|2.89||||||The co-primary objective of this study (ROW agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the CE in adult subjects with cIAI.|
1662917|NCT01499290|3059816|Non-Inferiority or Equivalence|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-2.4|||||2-Sided|95.0|-6.9|2.1||||||The co-primary objective of this study (ROW agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the MITT in adult subjects with cIAI.|
1662918|NCT01499290|3059817|Non-Inferiority or Equivalence|Non-inferiority was determined by comparing the lower limit of the 95% confidence interval for risk difference (corresponding to a 97.5% 1-sided lower bound) to the non-inferiority marging of -12.5%|Risk Difference (RD)|-3.5|||||2-Sided|95.0|-8.64|1.58||||||The primary objective of this study (FDA agreed) was to determine the noninferiority in the clinical cure rate for CAZ-AVI compared to that for Meropenem at TOC in the mMITT in adult subjects with cIAI.|
1662919|NCT01499277|3059819|Superiority or Other||Risk Difference (RD)|-1.86|||||2-Sided|95.0|-6.34|3.15|||||CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.||
1662920|NCT01499277|3059820|Superiority or Other||Risk Difference (RD)|-0.79|||||2-Sided|95.0|-3.98|1.18|||||CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.||
1662921|NCT01499277|3059821|Superiority or Other||Risk Difference (RD)|2.92|||||2-Sided|95.0|-2.19|8.73|||||CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.||
1662922|NCT01499277|3059822|Superiority or Other||Risk Difference (RD)|1.25|||||2-Sided|95.0|-4.05|7.06|||||CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.||
1662923|NCT01499277|3059823|Superiority or Other||Risk Difference (RD)|4.77|||||2-Sided|95.0|-2.11|12.86|||||CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.||
1662924|NCT01499277|3059824|Superiority or Other||Risk Difference (RD)|1.71|||||2-Sided|95.0|-6.21|10.39|||||CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.||
1662925|NCT01499277|3059825|Non-Inferiority or Equivalence|A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than –10% in both MITT and CE Populations. If non-inferioirity was achieved then a test of superioirty was conducted if lower limit of 95% CI for the difference was >0%.|Risk Difference (RD)|1.27|||||2-Sided|95.0|-4.32|7.48|||||CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.|
1662926|NCT01499277|3059826|Non-Inferiority or Equivalence|A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than –10% in both MITT and CE Populations.|Risk Difference (RD)|-0.95|||||2-Sided|95.0|-6.9|5.41|||||CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.|
1662927|NCT01499173|3059846|Other|odds ratio|Odds Ratio (OR)|-0.5|||||2-Sided|||||||||Odds ratio was calculated for each question comparing 1 week data with 1 month data|
1662928|NCT01499173|3059847|Superiority|||||||0.34|||||||multilevel linear regression||||
1662929|NCT01499173|3059848|Superiority||||||<|0.01||||||Actual p value shown here; not threshold.|multilevel linear regression||||
1662930|NCT01499160|3059850|Other|Not done due to low accrual||||||||||||||||Not done due to low accrual|Not done due to low accrual
1662931|NCT01499134|3059856|Superiority or Other|||||||0.595|||||||Wilcoxon (Mann-Whitney)||||
1662932|NCT01499134|3059857|Superiority or Other|||||||0.17|||||||Wilcoxon (Mann-Whitney)||||
1662933|NCT01499134|3059858|Superiority or Other|||||||0.476|||||||Wilcoxon (Mann-Whitney)||||
1662934|NCT01499134|3059859|Superiority or Other|||||||0.017|||||||Wilcoxon (Mann-Whitney)||||
1662935|NCT01499134|3059860|Superiority or Other|||||||0.363|||||||Wilcoxon (Mann-Whitney)||||
1662936|NCT01499134|3059861|Superiority or Other|||||||1||||||This p-value is correct, confirmed with report from statistician.|Wilcoxon (Mann-Whitney)||||
1662937|NCT01499134|3059862|Superiority or Other|||||||0.585|||||||Wilcoxon (Mann-Whitney)||||
1662938|NCT01499134|3059863|Superiority or Other|||||||0.039|||||||Wilcoxon (Mann-Whitney)||||
1662939|NCT01499095|3059864|Superiority or Other||LS Mean Difference|0.13|Standard Error of the Mean|0.142|||2-Sided|95.0|-0.152|0.415||||||Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline (Month 6) HbA1c value as a covariate.|
1662940|NCT01499095|3059873|Superiority or Other||LS Mean Difference|-0.04|Standard Error of the Mean|0.201||0.8279|2-Sided|95.0|-0.438|0.35|||ANCOVA|||Change in pre­injection SMPG was analysed using an ANCOVA model with treatment, strata of screening HbA1c (<8.0 and >=8.0%), and country as fixed effects and using the pre­injection SMPG baseline value as a covariate. A test for superiority of HOE901­U300 over Lantus was to be performed one­sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycaemia was significant.|
1662941|NCT01499095|3059874|Superiority or Other||Risk Ratio (RR)|0.77||||0.038|2-Sided|95.0|0.61|0.99|||Cochran-Mantel-Haenszel|||A one­sided test (at alpha=0.025) for superiority of HOE901­U300 over Lantus was to be performed in case the non­inferiority of HOE901­U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran­Mantel­Haenszel (CMH) method with treatment as a factor and stratified on strata of screening HbA1c (<8.0 and >=8.0%).|
1662942|NCT01499095|3059875|Non-Inferiority or Equivalence|"Stepwise closed testing approach was to assess non-inferiority and superiority sequentially:~Non­inferiority of HOE901­U300 vs Lantus: Upper bound of two­sided 95% confidence interval (CI) of difference between HOE901­U300 and Lantus on mITT population is <0.4%.~Superiority (only if non­inferiority has been demonstrated): Upper bound of two­sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901­U300 and Lantus on mITT population is <0."|Least Squares (LS) Mean difference|-0.01|Standard Error of the Mean|0.066|||2-Sided|95.0|-0.139|0.119||||||Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (<8.0 and >=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.|
1662943|NCT01499082|3059876|Superiority or Other||LS Mean Difference|0.05|Standard Error of the Mean|0.123|||2-Sided|95.0|-0.189|0.298||||||Analysis was performed using Analysis of covariance (ANCOVA) model with treatment regimen and country as fixed effects and baseline HbA1c value as a covariate.|
1662944|NCT01499082|3059885|Superiority or Other||LS Mean Difference|-0.06|Standard Error of the Mean|0.162||0.6909|2-Sided|95.0|-0.383|0.254|||ANCOVA|||Change in pre-injection SMPG was analyzed using an ANCOVA model with treatment, strata of screening HbA1c (<8.0 and >=8.0%), and country as fixed effects and using the pre-injection SMPG baseline value as a covariate. A test for superiority of HOE901-U300 over Lantus was to be performed one-sided at level alpha = 0.025 if previous analysis for nocturnal hypoglycemia was significant.|
1662945|NCT01499082|3059886|Superiority or Other||Risk Ratio (RR)|0.79||||0.0045|2-Sided|95.0|0.67|0.93|||Cochran-Mantel-Haenszel|||A one-sided test (at alpha=0.025) for superiority of HOE901-U300 over Lantus was to be performed in case the non-inferiority of HOE901-U300 vs Lantus for the primary endpoint was demonstrated. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with treatment as a factor and stratified on strata of screening HbA1c (<8.0 and >=8.0%).|
1662946|NCT01499082|3059887|Non-Inferiority or Equivalence|"Stepwise closed testing approach was used to assess non-inferiority and superiority sequentially:~Non-inferiority of HOE901-U300 vs Lantus: Upper bound of two-sided 95% confidence interval (CI) of difference between HOE901-U300 and Lantus on mITT population is <0.4%.~Superiority (only if non-inferiority has been demonstrated): Upper bound of two-sided 95% CI for difference in mean change in HbA1c from baseline to endpoint between HOE901-U300 and Lantus on mITT population is <0."|Least Squares (LS) Mean Difference|0.0|Standard Error of the Mean|0.056|||2-Sided|95.0|-0.112|0.107||||||Analysis was performed using an analysis of covariance (ANCOVA) model with treatment, strata of screening HbA1c (<8.0 and >=8.0%), and country as fixed effects and using the HbA1c baseline value as a covariate.|
1662947|NCT01498978|3059899|Other|Test of association (contingency) between the two kinds of classification.||||||0.524|||||||Fisher Exact||||
1662948|NCT01498978|3059900|Other|Test of association (contingency) between the two kinds of classification.||||||1|||||||Fisher Exact||||
1662949|NCT01498978|3059901|Other|Test of association (contingency) between the two kinds of classification.||||||0.5|||||||Fisher Exact||||
1662950|NCT01498978|3059904|Other|Test of association (contingency) between the two kinds of classification.||||||0.19|||||||Fisher Exact||||
1662951|NCT01498978|3059905|Other|Exact binomial test (two-sided).||||||0.754|||||||Exact Binomial Test|||Exact binomial test (two-sided). Null hypothesis: the proportion is equal to 0.5|
1662952|NCT01498887|3059930|Superiority or Other|||||||0.3118|||||||Wilcoxon (Mann-Whitney)||||
1662953|NCT01498822|3059934|Non-Inferiority or Equivalence|The primary analysis of this study aimed to demonstrate that LEV was noninferior to OXC with respect to the treatment failure rate in the Per Protocol Set. The noninferiority margin was 15 %.|Absolut difference|-10.7|||||2-Sided|95.0|-20.2|-1.2|||||"Absolute difference in treatment failure rates of LEV versus OXC is defined as Treatment Failure Rate LEV minus Treatment Failure Rate OXC."||
1662954|NCT01498692|3059964|Superiority or Other||Percent Target Lesion Failure|2.4|||<|0.0001|1-Sided|95.0||7.3|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the primary endpoint rate in the PROMUS Element cohort is less than the predefined performance goal of 21.1%.|
1662955|NCT01498679|3059969|Superiority or Other||Least Squares Mean Difference|51.0|||<|0.001|2-Sided|95.0|42.2|59.7|||ANCOVA||||
1662956|NCT01498653|3059974|Superiority or Other||Least Squares Mean Difference|28.5|||<|0.001|2-Sided|95.0|20.1|36.9|||ANCOVA||||
1662957|NCT01498289|3060001|Superiority||Hazard Ratio (HR)|0.74||||0.3|2-Sided|95.0|0.42|1.31|||Regression, Cox|||Statistical analysis for Q4 ERCC1|
1663228|NCT01494038|3060459|Superiority|||||||0.012|||||||Fisher Exact|Mid-P adjustment|||
1662958|NCT01498289|3060001|Superiority||Hazard Ratio (HR)|0.88||||0.66|2-Sided|95.0|0.49|1.58|||Regression, Cox|||Statistical analysis for Q3 ERCC1|
1662959|NCT01498289|3060001|Superiority||Hazard Ratio (HR)|0.57||||0.06|2-Sided|95.0|0.32|1.02|||Regression, Cox|||Statistical analysis for Q2 ERCC1|
1662960|NCT01498289|3060001|Superiority||Hazard Ratio (HR)|0.78||||0.41|2-Sided|95.0|0.44|1.4|||Regression, Cox|||Statistical analysis for Q1 ERCC1|
1662961|NCT01498289|3060002|Superiority|||||||0.1|||||||Chi-squared||||
1662962|NCT01498289|3060003|Superiority||Hazard Ratio (HR)|0.82||||0.2|2-Sided|95.0|0.61|1.11|||Regression, Cox||||
1662963|NCT01498289|3060004|Superiority||Hazard Ratio (HR)|0.68||||0.02|2-Sided|95.0|0.5|0.93|||Regression, Cox||||
1662964|NCT01498289|3060005|Superiority||Cox Proportional Hazard|0.91||||0.83|2-Sided|95.0|0.41|2.05|||Regression, Cox||||
1662965|NCT01498185|3060013|Superiority or Other||Mean Difference (Final Values)|-1.03|Standard Error of the Mean|18.4617|||2-Sided|95.0|-39.22|37.16|||||||
1662966|NCT01498185|3060013|Superiority or Other||Mean Difference (Final Values)|-6.88|Standard Error of the Mean|17.1548|||2-Sided|95.0|-42.21|28.45|||||||
1662967|NCT01498185|3060013|Superiority or Other||Mean Difference (Final Values)|-0.77|Standard Error of the Mean|16.7228|||2-Sided|95.0|-35.36|33.82|||||||
1662968|NCT01498185|3060013|Superiority or Other||Mean Difference (Final Values)|-2.5|Standard Error of the Mean|18.5425|||2-Sided|95.0|-40.85|35.86|||||||
1662969|NCT01497938|3060022|Superiority or Other||Mean Difference (Final Values)|-588.0|||<|0.025||95.0|||||ANCOVA||||
1662970|NCT01497938|3060023|Non-Inferiority or Equivalence|pre-specified non-inferiority margin of 0.4% was used for sample size calculation. sample size is based on two-sample t test with one-sided type 1 error of 2.5%. Assuming a same mean of change in A1C for the treatment arm and control arm and a common standard deviation of 1% for both treatment groups, it showed that a total of 200 subjects will provide over 80% power to detect the non-inferiority with a margin of 0.4%|Mean Difference (Final Values)|0.05|||||1-Sided|97.5||0.15|||||||
1662971|NCT01497899|3060027|Non-Inferiority or Equivalence|The null hypothesis was that the E/C/F/TAF group was at least 12% lower than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24. The alternative hypothesis was that the E/C/F/TAF group was less than 12% lower than the E/C/F/TDF group.|Difference in percentages|-2.9||||0.58|2-Sided|95.0|-13.5|7.7|||Cochran-Mantel-Haenszel|P-value comparing the percentages of virologic success was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum.|Difference in percentages of virologic success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.||
1662972|NCT01497366|3060058|Non-Inferiority or Equivalence|Non-inferiority would be demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 rates was greater than -15%.|Difference in percentages|0.3|||||2-Sided|95.0|-7.5|8.0|||||The difference in percentages between treatment groups and the 95% CI calculated were based on stratum adjusted Mantel-Haenszel proportions.||
1662973|NCT01496846|3060078|Superiority|||||||0.437|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.|||
1662974|NCT01496846|3060079|Superiority|||||||0.004|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.|||
1662975|NCT01496846|3060079|Superiority|||||||0.901|||||||Chi-squared|We used the Chi-Square Test or Fisher's Exact test on the raw data depending on the number of data points in the table cells.|||
1662976|NCT01496469|3060087|Superiority or Other||Least Squares Mean Difference|-3.4|||<|0.001|2-Sided|95.0|-3.9|-2.9||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.|
1662977|NCT01496469|3060088|Superiority or Other||Least Squares Mean Difference|0.6||||0.613|2-Sided|95.0|-1.9|3.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.|
1662978|NCT01496469|3060089|Superiority or Other||Least Squares Mean Difference|-0.3||||0.882|2-Sided|95.0|-3.9|3.4||Analysis of covariance (ANCOVA) model with treatment as a factor, and the baseline value and prior use of an ARB or an ACEi as covariates.|ANCOVA|||A total of 120 enrolled participants (60 participants per treatment group) was sufficient to achieve 80 percent (%) power to detect a difference of 6.0 mmHg between the placebo and febuxostat 80 mg treatment groups by a 2 sample t-test of the mean change from Baseline at Week 6 in 24-hour mean ambulatory SBP with a 2-sided significance level of 5%.|
1662979|NCT01496456|3060090|Superiority or Other|||||||0.0077|||||||Discreet Time Survival Analysis|Controlled for correlation among tooth pairs (GEE model).|||
1662980|NCT01496456|3060091|Superiority or Other|||||||0.045|||||||Regression, Logistic|Ordinal logistic regression, controlled for correlation among pairs of teeth using the GEE method.|||
1662981|NCT01496456|3060092|Superiority or Other|||||||0.002|||||||Regression, Logistic|Ordinal logistic regression, controlled for baseline lesion size and for correlation among pairs of teeth using the GEE method.|||
1662982|NCT01496430|3060114|Superiority or Other|||||||0.21||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA||||
1662983|NCT01496430|3060114|Superiority or Other|||||||0.86||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA||||
1662984|NCT01496430|3060115|Superiority or Other|||||||0.067||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA||||
1662985|NCT01496430|3060115|Superiority or Other|||||||0.007||||||Sequential testing was used to control for multiple comparisons. Azilsartan medoxomil 80 mg was first compared to placebo and if p-value ≤0.05 then azilsartaon medoxomil 40 mg was compared to placebo.|ANCOVA||||
1663043|NCT01494532|3060383|Superiority or Other|||||||0.409||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663044|NCT01494532|3060384|Superiority or Other|||||||0.153||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1662986|NCT01496274|3060145|Superiority or Other||||||<|0.0001||||||P value is based on a Wilcoxon signed-rank test of H0: AsBR ratio (prophylaxis regimen/on-demand regimen) ≥ 0.50. The ratio was based on the original scale.|Wilcoxon signed-rank test|||A test of null hypothesis that the ratio of AsBR (prophylaxis regimen/on-demand regimen) was ≥ 0.50 was conducted at the 1-sided 0.025 level. Matched pairs design with 19 subjects and 2 observations per subject.|
1662987|NCT01496248|3060146|Superiority or Other||||||<|0.05|||||||ANOVA||||
1662988|NCT01496248|3060147|Superiority or Other||||||<|0.05|||||||ANOVA||||
1662989|NCT01496248|3060148|Superiority or Other||||||<|0.05|||||||ANOVA||||
1662990|NCT01496248|3060149|Superiority or Other||||||<|0.05|||||||ANOVA||||
1662991|NCT01496248|3060150|Superiority or Other||||||<|0.05|||||||ANOVA||||
1662992|NCT01496248|3060151|Superiority or Other||||||<|0.05|||||||ANOVA||||
1662993|NCT01496248|3060152|Superiority or Other||||||<|0.05|||||||ANOVA||||
1662994|NCT01496248|3060153|Superiority or Other||||||<|0.05|||||||ANOVA||||
1662995|NCT01496066|3060173|Equivalence|a two-group t-test of equivalence in means was used|Mean Difference (Final Values)|-0.04|||||2-Sided|99.0|-0.06|-0.02|||||||
1662996|NCT01496066|3060174|Superiority|||||||0.0318|||||||t-test, 2 sided||||
1662997|NCT01496066|3060175|Superiority||||||<|0.0001|||||||t-test, 2 sided||||
1662998|NCT01496066|3060176|Superiority||||||<|0.0001|||||||t-test, 2 sided||||
1662999|NCT01496066|3060177|Superiority||||||<|0.0001|||||||Chi-squared||||
1663000|NCT01495858|3060209|Superiority or Other|||||||0.3765|||||||Cochran-Mantel-Haenszel||||
1663001|NCT01495858|3060211|Superiority or Other||||||>|0.05|||||||Log Rank||||
1663002|NCT01495858|3060212|Superiority or Other|||||||0.3707|||||||ANCOVA||||
1663003|NCT01495858|3060213|Superiority or Other|||||||0.4519|||||||ANCOVA||||
1663004|NCT01495858|3060214|Superiority or Other||||||>|0.05|||||||Cochran-Mantel-Haenszel||||
1663005|NCT01495858|3060215|Superiority or Other||||||>|0.05|||||||Cochran-Mantel-Haenszel||||
1663006|NCT01495858|3060216|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1663007|NCT01495858|3060217|Superiority or Other|||||||0.0036|||||||Cochran-Mantel-Haenszel||||
1663008|NCT01495858|3060218|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1663009|NCT01495858|3060219|Superiority or Other|||||||0.0176|||||||Cochran-Mantel-Haenszel||||
1663010|NCT01495858|3060220|Superiority or Other|||||||0.0305|||||||Cochran-Mantel-Haenszel||||
1663011|NCT01495858|3060221|Superiority or Other|||||||0.0387|||||||Cochran-Mantel-Haenszel||||
1663012|NCT01495858|3060222|Superiority or Other||||||>|0.05|||||||Cochran-Mantel-Haenszel||||
1663013|NCT01495858|3060223|Superiority or Other|||||||0.0145|||||||Cochran-Mantel-Haenszel||||
1663014|NCT01495858|3060224|Superiority or Other|||||||0.0004|||||||Cochran-Mantel-Haenszel||||
1663015|NCT01495858|3060225|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1663016|NCT01495858|3060226|Superiority or Other|||||||0.2764|||||||ANCOVA||||
1663017|NCT01495858|3060227|Superiority or Other|||||||0.2764|||||||ANCOVA||||
1663018|NCT01495858|3060228|Superiority or Other|||||||0.1677|||||||Log Rank||||
1663019|NCT01495858|3060229|Superiority or Other|||||||0.3047|||||||ANCOVA||||
1663020|NCT01495702|3060241|Non-Inferiority or Equivalence|The null hypothesis was that the Stribild group was at least 12% worse than the NNRTI+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA < 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the NNRTI+FTC/TDF group.|Difference in proportions|5.3||||0.066|2-Sided|95.0|-0.5|12.0|||Fisher Exact||The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.||
1663021|NCT01495585|3060245|Superiority or Other|||||||0.6|||||||Wilcoxon (Mann-Whitney)||||
1663022|NCT01495585|3060245|Superiority or Other|||||||0.96|||||||Wilcoxon (Mann-Whitney)||||
1663023|NCT01495585|3060246|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Student t-test was used on the change in serum log HDV RNA after 28 days of therapy with lonafarnib.|
1663024|NCT01495585|3060246|Superiority or Other||||||<|0.03|||||||t-test, 2 sided|||Student t-test was used on the change in serum log HDV RNA after 28 days of therapy with lonafarnib.|
1663025|NCT01495000|3060279|Superiority or Other||Mean Difference (Final Values)|3.05|||<|0.0001|2-Sided|95.0|1.91|4.19|||ANCOVA||||
1663026|NCT01494987|3060283|Superiority or Other||difference in least squares mean (LSM)|-0.51|||<|0.001|2-Sided|95.0|-0.71|-0.32||P-value is from a mixed-effect model including terms for baseline HbA1c value, prior antihyperglycemia therapy, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.5% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.|
1663027|NCT01494649|3060293|Superiority or Other||Mean adjusted difference|8.69||||0.0004|2-Sided|95.0|3.96|13.43||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline tactile threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1663028|NCT01494649|3060294|Superiority or Other||Adjusted mean|-2.07||||0.22|2-Sided|95.0|-5.38|1.25||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline tactile threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1663045|NCT01494532|3060384|Superiority or Other|||||||0.003||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663029|NCT01494649|3060295|Superiority or Other||Mean adjusted difference|-0.08||||0.9445|2-Sided|95.0|-2.49|2.32||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Tactile Threshold score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1663030|NCT01494649|3060296|Superiority or Other||Adjusted mean difference|-0.52|||<|0.0001|2-Sided|95.0|-0.74|-0.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Schiff Sensitivity Score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1663031|NCT01494649|3060297|Superiority or Other||Adjusted mean difference|-0.12||||0.1792||95.0|-0.3|0.06||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment was a fixed factor and baseline Schiff Sensitivity Score was a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favored stannous fluoride toothpaste.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1663032|NCT01494649|3060298|Superiority or Other||Adjusted mean difference|-0.1||||0.2294|2-Sided|95.0|-0.26|0.06||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|The model included treatment as a fixed factor and basline Schiff score as a covariate.|Difference was calculated as adjusted mean change from baseline in 0.454% stannous fluoride toothpaste minus 0.76% sodium fluoride toothpaste. Negative difference favoured stannous fluoride toothpaste.|Null hypothesis is no difference between treatments. Tests were 2-sided.|
1663033|NCT01494610|3060326|Non-Inferiority or Equivalence|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.966|||||2-Sided|90.0|0.889|1.049|||||Data reflect participants with COPD only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.||
1663034|NCT01494610|3060326|Non-Inferiority or Equivalence|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.892|||||2-Sided|90.0|0.848|0.939|||||Data reflect participants with asthma only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.||
1663035|NCT01494610|3060326|Non-Inferiority or Equivalence|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|0.928|||||2-Sided|90.0|0.886|0.971|||||Data reflect Asthma + COPD participants. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.||
1663036|NCT01494610|3060327|Non-Inferiority or Equivalence|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.421|||||2-Sided|90.0|1.274|1.584|||||Data reflect participants with COPD only. The ratio of adjusted geometric means is the comparision of treatment administered by the capsule-based inhaler and the MDPI.||
1663037|NCT01494610|3060327|Non-Inferiority or Equivalence|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.598|||||2-Sided|90.0|1.369|1.864|||||Data reflect participants with asthma only. The ratio of adjusted geometric means is a comparision of treatment administered by the capsule-based inhaler and the MDPI.||
1663038|NCT01494610|3060327|Non-Inferiority or Equivalence|Estimates of within-par. coefficient of variation for AUC(0-tau) of FP and weighted mean (0-12 h) serum cortisol from previous studies showed that a sample size of 52 par. would have approximately 90% power to demonstrate biocomparability with respect to the two co-primary endpoints. The study was powered on the analysis of asthma and COPD par. as a combined group. A two one-sided t-test procedure with α=0.05 for each one-sided test was used. Biocomparability limits of 0.8 and 1.25 were used.|Ratio of adjusted geometric means|1.508|||||2-Sided|90.0|1.366|1.665|||||Data reflect Asthma + COPD participants. The ratio of adjusted geometric means is a comparision of treatment administered by the capsule-based inhaler and the MDPI.||
1663039|NCT01494532|3060383|Superiority or Other|||||||0.348||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663040|NCT01494532|3060383|Superiority or Other|||||||0.169||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663041|NCT01494532|3060383|Superiority or Other|||||||0.992||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663042|NCT01494532|3060383|Superiority or Other|||||||0.598||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663227|NCT01494038|3060456|Superiority|||||||0.279|||||||Fisher Exact|mid-P adjustment|||
1663046|NCT01494532|3060384|Superiority or Other|||||||0.17||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663047|NCT01494532|3060384|Superiority or Other|||||||0.068||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663048|NCT01494532|3060384|Superiority or Other|||||||0.292||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663049|NCT01494532|3060385|Superiority or Other|||||||0.039||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663050|NCT01494532|3060385|Superiority or Other|||||||0.034||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663051|NCT01494532|3060385|Superiority or Other|||||||0.172||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663052|NCT01494532|3060385|Superiority or Other|||||||0.005||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663053|NCT01494532|3060385|Superiority or Other|||||||0.047||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663054|NCT01494532|3060386|Superiority or Other|||||||0.008||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663055|NCT01494532|3060386|Superiority or Other|||||||0.005||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663056|NCT01494532|3060386|Superiority or Other|||||||0.016||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663057|NCT01494532|3060386|Superiority or Other|||||||0.014||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663058|NCT01494532|3060386|Superiority or Other|||||||0.007||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663059|NCT01494532|3060387|Superiority or Other|||||||0.6||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663060|NCT01494532|3060387|Superiority or Other|||||||0.747||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663061|NCT01494532|3060387|Superiority or Other|||||||0.791||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663062|NCT01494532|3060387|Superiority or Other|||||||0.996||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663063|NCT01494532|3060387|Superiority or Other|||||||0.073||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663064|NCT01494532|3060388|Superiority or Other|||||||0.266||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663065|NCT01494532|3060388|Superiority or Other|||||||0.033||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663066|NCT01494532|3060388|Superiority or Other|||||||0.23||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663067|NCT01494532|3060388|Superiority or Other|||||||0.026||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663068|NCT01494532|3060388|Superiority or Other|||||||0.419||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663069|NCT01494532|3060389|Superiority or Other|||||||0.403||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663070|NCT01494532|3060389|Superiority or Other|||||||0.089||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663071|NCT01494532|3060389|Superiority or Other|||||||0.362||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663072|NCT01494532|3060389|Superiority or Other|||||||0.036||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663073|NCT01494532|3060389|Superiority or Other|||||||0.376||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663074|NCT01494532|3060390|Superiority or Other|||||||0.39||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663075|NCT01494532|3060390|Superiority or Other|||||||0.027||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663076|NCT01494532|3060390|Superiority or Other|||||||0.287||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663077|NCT01494532|3060390|Superiority or Other|||||||0.013||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663078|NCT01494532|3060390|Superiority or Other|||||||0.814||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663079|NCT01494532|3060391|Superiority or Other|||||||0.458||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663080|NCT01494532|3060391|Superiority or Other|||||||0.039||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663081|NCT01494532|3060391|Superiority or Other|||||||0.267||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663082|NCT01494532|3060391|Superiority or Other|||||||0.025||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663083|NCT01494532|3060391|Superiority or Other|||||||0.822||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663084|NCT01494532|3060392|Superiority or Other|||||||0.641||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663085|NCT01494532|3060392|Superiority or Other|||||||0.123||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663086|NCT01494532|3060392|Superiority or Other|||||||0.443||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663087|NCT01494532|3060392|Superiority or Other|||||||0.048||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663088|NCT01494532|3060392|Superiority or Other|||||||0.734||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663089|NCT01494532|3060393|Superiority or Other|||||||0.458||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663090|NCT01494532|3060393|Superiority or Other|||||||0.039||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663091|NCT01494532|3060393|Superiority or Other|||||||0.267||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663092|NCT01494532|3060393|Superiority or Other|||||||0.025||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663093|NCT01494532|3060393|Superiority or Other|||||||0.822||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663094|NCT01494532|3060394|Superiority or Other|||||||0.47||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663095|NCT01494532|3060394|Superiority or Other|||||||0.903||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663096|NCT01494532|3060394|Superiority or Other|||||||0.859||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663097|NCT01494532|3060394|Superiority or Other|||||||0.768||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663098|NCT01494532|3060394|Superiority or Other|||||||0.134||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663099|NCT01494532|3060395|Superiority or Other|||||||0.187||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663100|NCT01494532|3060395|Superiority or Other|||||||0.081||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663101|NCT01494532|3060395|Superiority or Other|||||||0.121||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663102|NCT01494532|3060395|Superiority or Other|||||||0.026||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663103|NCT01494532|3060395|Superiority or Other|||||||0.486||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663104|NCT01494532|3060396|Superiority or Other|||||||0.581||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663105|NCT01494532|3060396|Superiority or Other|||||||0.148||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663106|NCT01494532|3060396|Superiority or Other|||||||0.283||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663107|NCT01494532|3060396|Superiority or Other|||||||0.126||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663108|NCT01494532|3060396|Superiority or Other|||||||0.337||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663109|NCT01494532|3060397|Superiority or Other|||||||0.659||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663110|NCT01494532|3060397|Superiority or Other|||||||0.008||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663111|NCT01494532|3060397|Superiority or Other|||||||0.312||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663112|NCT01494532|3060397|Superiority or Other|||||||0.017||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663113|NCT01494532|3060397|Superiority or Other|||||||0.998||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663114|NCT01494532|3060398|Superiority or Other|||||||0.6||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663115|NCT01494532|3060398|Superiority or Other|||||||0.747||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663116|NCT01494532|3060398|Superiority or Other|||||||0.791||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663117|NCT01494532|3060398|Superiority or Other|||||||0.996||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663118|NCT01494532|3060398|Superiority or Other|||||||0.073||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663119|NCT01494532|3060399|Superiority or Other|||||||0.266||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663120|NCT01494532|3060399|Superiority or Other|||||||0.033||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663121|NCT01494532|3060399|Superiority or Other|||||||0.23|||||||Mixed Models Analysis||||
1663122|NCT01494532|3060399|Superiority or Other|||||||0.026||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663123|NCT01494532|3060399|Superiority or Other|||||||0.419||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663124|NCT01494532|3060400|Superiority or Other|||||||0.403||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663125|NCT01494532|3060400|Superiority or Other|||||||0.089||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663126|NCT01494532|3060400|Superiority or Other|||||||0.362||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663127|NCT01494532|3060400|Superiority or Other|||||||0.036||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663128|NCT01494532|3060400|Superiority or Other|||||||0.376||||||Mixed Model Repeated Measures|Mixed Models Analysis||||
1663129|NCT01494532|3060402|Superiority or Other||Odds Ratio (OR)|0.907||||0.856|2-Sided|95.0|0.315|2.61|||Generalized Estimating Equations model||||
1663130|NCT01494532|3060402|Superiority or Other||Odds Ratio (OR)|1.48||||0.329|2-Sided|95.0|0.674|3.248|||Generalized Estimating Equations model||||
1663131|NCT01494532|3060402|Superiority or Other||Odds Ratio (OR)|0.996||||0.992|2-Sided|95.0|0.444|2.232|||Generalized Estimating Equations model||||
1663132|NCT01494532|3060402|Superiority or Other||Odds Ratio (OR)|1.851||||0.13|2-Sided|95.0|0.834|4.109|||Generalized Estimating Equations model||||
1663133|NCT01494532|3060402|Superiority or Other||Odds Ratio (OR)|0.723||||0.525|2-Sided|95.0|0.266|1.965|||Generalized Estimating Equations model||||
1663134|NCT01494532|3060403|Superiority or Other||Odds Ratio (OR)|1.689||||0.362|2-Sided|95.0|0.547|5.218|||Generalized Estimating Equations model||||
1663135|NCT01494532|3060403|Superiority or Other||Odds Ratio (OR)|1.916||||0.14|2-Sided|95.0|0.808|4.545|||Generalized Estimating Equations model||||
1663136|NCT01494532|3060403|Superiority or Other||Odds Ratio (OR)|1.074||||0.869|2-Sided|95.0|0.461|2.5|||Generalized Estimating Equations model||||
1663137|NCT01494532|3060403|Superiority or Other||Odds Ratio (OR)|1.608||||0.277|2-Sided|95.0|0.684|3.782|||Generalized Estimating Equations model||||
1663138|NCT01494532|3060403|Superiority or Other||Odds Ratio (OR)|0.908||||0.861|2-Sided|95.0|0.31|2.659|||Generalized Estimating Equations model||||
1663139|NCT01494532|3060404|Superiority or Other||Odds Ratio (OR)|1.362||||0.564|2-Sided|95.0|0.477|3.888|||Generalized Estimating Equations model||||
1663140|NCT01494532|3060404|Superiority or Other||Odds Ratio (OR)|1.866||||0.127|2-Sided|95.0|0.837|4.158|||Generalized Estimating Equations model||||
1663141|NCT01494532|3060404|Superiority or Other||Odds Ratio (OR)|0.953||||0.902|2-Sided|95.0|0.439|2.065|||Generalized Estimating Equations model||||
1663142|NCT01494532|3060404|Superiority or Other||Odds Ratio (OR)|1.622||||0.233|2-Sided|95.0|0.732|3.593|||Generalized Estimating Equations model||||
1663143|NCT01494532|3060404|Superiority or Other||Odds Ratio (OR)|1.123||||0.826|2-Sided|95.0|0.398|3.166|||Generalized Estimating Equations model||||
1663144|NCT01494532|3060405|Superiority or Other|||||||0.808||||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||24 mg/day vs Placebo|
1663145|NCT01494532|3060405|Superiority or Other|||||||0.034||||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||16 mg/day vs Placebo|
1663146|NCT01494532|3060405|Superiority or Other|||||||0.437||||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||12 mg/day vs Placebo|
1663147|NCT01494532|3060405|Superiority or Other|||||||0.03||||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||8 mg/day vs Placebo|
1663148|NCT01494532|3060405|Superiority or Other|||||||0.844||||||P-values are from a nonparametric rank ANCOVA|ANCOVA|||4mg/day vs Placebo|
1663149|NCT01494532|3060405|Superiority or Other|||||||0.39||||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||24 mg/day vs Placebo|
1663150|NCT01494532|3060405|Superiority or Other|||||||0.027||||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||16 mg/day vs Placebo|
1663151|NCT01494532|3060405|Superiority or Other|||||||0.287||||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||12 mg/day vs Placebo|
1663152|NCT01494532|3060405|Superiority or Other|||||||0.013||||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||8 mg/day vs Placebo|
1663153|NCT01494532|3060405|Superiority or Other|||||||0.814||||||P-values were estimated from Mixed Model Repeated Measures (MMRM).|Mixed Models Analysis|||4mg/day vs Placebo|
1663154|NCT01494506|3060407|Superiority or Other|||||||0.7308||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Financial difficulties|
1663155|NCT01494506|3060407|Superiority or Other|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Financial difficulties|
1663156|NCT01494506|3060407|Superiority or Other|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Diarrhoea|
1663157|NCT01494506|3060407|Superiority or Other|||||||0.1628||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Diarrhoea|
1663158|NCT01494506|3060407|Superiority or Other|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Constipation|
1663159|NCT01494506|3060407|Superiority or Other|||||||0.7617||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Constipation|
1663160|NCT01494506|3060407|Superiority or Other|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Appetite loss|
1663161|NCT01494506|3060407|Superiority or Other|||||||0.9123||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Appetite loss|
1663162|NCT01494506|3060407|Superiority or Other|||||||0.6712|||||||Cochran-Mantel-Haenszel|||Comparison of Insomnia|
1663163|NCT01494506|3060407|Superiority or Other|||||||0.7617||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Insomnia|
1663164|NCT01494506|3060407|Superiority or Other|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Dyspnoea|
1663165|NCT01494506|3060407|Superiority or Other|||||||0.2654||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Dyspnoea|
1663166|NCT01494506|3060407|Superiority or Other|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Pain|
1663167|NCT01494506|3060407|Superiority or Other|||||||0.4993||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Pain|
1663168|NCT01494506|3060407|Superiority or Other|||||||0.7674||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Nausea and Vomiting|
1663169|NCT01494506|3060407|Superiority or Other|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Nausea and Vomiting|
1663170|NCT01494506|3060407|Superiority or Other|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Fatigue|
1663171|NCT01494506|3060407|Superiority or Other|||||||0.6766||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Fatigue|
1663172|NCT01494506|3060407|Superiority or Other|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Social Functioning|
1663173|NCT01494506|3060407|Superiority or Other|||||||0.3408||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Social Functioning|
1663174|NCT01494506|3060407|Superiority or Other|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Cognitive Functioning|
1663175|NCT01494506|3060407|Superiority or Other|||||||0.7738||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Cognitive Functioning|
1663176|NCT01494506|3060407|Superiority or Other|||||||0.6712||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Emotional Functioning|
1663177|NCT01494506|3060407|Superiority or Other|||||||0.1628||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Emotional Functioning|
1663178|NCT01494506|3060407|Superiority or Other|||||||0.7674||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Role functioning|
1663179|NCT01494506|3060407|Superiority or Other|||||||0.2654||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Role functioning|
1663180|NCT01494506|3060407|Superiority or Other|||||||0.9435||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Physical Functioning|
1663181|NCT01494506|3060407|Superiority or Other|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Physical Functioning|
1663182|NCT01494506|3060407|Superiority or Other|||||||0.8445||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Global Health Status|
1663183|NCT01494506|3060407|Superiority or Other|||||||0.6388||||||For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.|Cochran-Mantel-Haenszel|||Comparison of Global Health Status|
1663184|NCT01494506|3060408|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1663185|NCT01494506|3060408|Superiority or Other||||||<|0.024|||||||Fisher Exact||||
1663186|NCT01494506|3060409|Superiority or Other|||||||0.8|||||||Fisher Exact||||
1663187|NCT01494506|3060409|Superiority or Other|||||||0.82|||||||Fisher Exact||||
1663188|NCT01494506|3060410|Superiority or Other||Hazard Ratio (HR)|0.6||||0.0002|2-Sided|95.0|0.45|0.78|||Log Rank|Unstratified log rank test|||
1663189|NCT01494506|3060410|Superiority or Other||Hazard Ratio (HR)|0.82||||0.1008|2-Sided|95.0|0.65|1.03|||Log Rank|Unstratified log rank test.|||
1663190|NCT01494506|3060411|Superiority or Other||Risk Difference (RD)|0.069||||0.01|2-Sided|95.0|0.018|0.12|||Fisher Exact||||
1663191|NCT01494506|3060411|Superiority or Other||Risk Difference (RD)|0.0264||||0.214|2-Sided|95.0|-0.005|0.058|||Fisher Exact||||
1663192|NCT01494506|3060412|Superiority or Other||Hazard Ratio (HR)|0.56|||<|0.001|2-Sided|95.0|0.41|0.75|||Log Rank||||
1663193|NCT01494506|3060412|Superiority or Other||Hazard Ratio (HR)|0.81|||<|0.1|2-Sided|95.0|0.63|1.04|||Log Rank||||
1663194|NCT01494506|3060413|Superiority or Other||Hazard Ratio (HR)|0.67||||0.012|2-Sided|95.0|0.49|0.92|||Log Rank|Unstratified logrank test.|||
1663195|NCT01494506|3060413|Superiority or Other||Hazard Ratio (HR)|0.99||||0.9416|2-Sided|95.0|0.77|1.28|||Log Rank|Unstratified logrank test.|||
1663196|NCT01494467|3060414|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1663197|NCT01494467|3060415|Superiority or Other||Mean Difference (Net)|-8.22|||<|0.001|2-Sided|95.0|-10.18|-6.25|||ANCOVA||||
1663198|NCT01494467|3060416|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1663199|NCT01494298|3060422|Superiority or Other|||||||0.84|||||||t-test, 2 sided||||
1663200|NCT01494298|3060424|Superiority or Other||||||=|0||||||The control group average age was 6 years lower(P=0.001). Results were adjusted via a logistic regression and presented as age-adjusted means and SE. The unadjusted differences had similar results.|t-test, 2 sided|||Hypothesis - There will be differences in ApoB between AA with T2DM and those without. To achieve a power of 80%, 48 subjects in each group were needed to detect 15 mg/dL difference in ApoB levels, assuming a standard deviation of 26 mg/dL if alpha was set at 0.05. Continuous data were compared using a Students t-test and categorical data were compared using test.|
1663201|NCT01494038|3060429|Other|Agreement between tests|Kappa coefficient|0.46|||||2-Sided|95.0|0.39|0.53|||||||
1663202|NCT01494038|3060429|Other|Agreement between tests|||||<|0.0001|||||||Chi-squared|McNemar's test|||
1663203|NCT01494038|3060430|Other|Agreement between tests|Kappa coefficient|0.11|||||2-Sided|95.0|0.001|0.21|||||||
1663204|NCT01494038|3060430|Other|Agreement between tests||||||0.22|||||||Chi-squared|McNemar's test|||
1663205|NCT01494038|3060431|Other|Agreement between tests|Kappa coefficient|0.42|||||2-Sided|95.0|0.35|0.5|||||||
1663206|NCT01494038|3060431|Other|Measuring agreement between the tests|||||<|0.0001|||||||Chi-squared|McNemars test|||
1663207|NCT01494038|3060436|Superiority||Incidence rate difference|3.39|||||2-Sided|95.0|-1.46|8.25|||||||
1663208|NCT01494038|3060437|Superiority||Incidence rate difference|-0.82|||||2-Sided|95.0|-4.63|3.0|||||||
1663209|NCT01494038|3060438|Superiority||Incidence rate difference|3.38|||||2-Sided|95.0|-1.31|8.07|||||||
1663210|NCT01494038|3060439|Superiority||Incidence rate difference|-0.82|||||2-Sided|95.0|-4.63|3.0|||||||
1663211|NCT01494038|3060440|Superiority||Incidence rate difference|3.39|||||2-Sided|95.0|-1.46|8.25|||||||
1663212|NCT01494038|3060441|Superiority||Incidence rate difference|-0.82|||||2-Sided|95.0|-4.63|3.0|||||||
1663213|NCT01494038|3060442|Superiority||Incidence rate difference|3.38|||||2-Sided|95.0|-1.31|8.07|||||||
1663214|NCT01494038|3060443|Superiority||Incidence rate difference|-0.82|||||2-Sided|95.0|-4.63|3.0|||||||
1663215|NCT01494038|3060444|Superiority||Incidence rate difference|15.88|||||2-Sided|95.0|2.11|29.65|||||||
1663216|NCT01494038|3060445|Superiority||Incidence rate difference|5.49|||||2-Sided|95.0|-13.7|24.68|||||||
1663217|NCT01494038|3060446|Superiority||Incidence rate difference|6.89|||||2-Sided|95.0|-0.08|13.86|||||||
1663218|NCT01494038|3060447|Superiority||Incidence rate difference|2.14|||||2-Sided|95.0|-7.86|12.13|||||||
1663219|NCT01494038|3060448|Superiority||Incidence rate difference|-1.3|||||2-Sided|95.0|-3.86|1.25|||||||
1663220|NCT01494038|3060449|Superiority||Incidence rate difference|-1.69|||||2-Sided|95.0|-4.48|1.1|||||||
1663221|NCT01494038|3060450|Superiority||Incidence rate difference|-0.38|||||2-Sided|95.0|-1.72|0.97|||||||
1663222|NCT01494038|3060451|Superiority||Incidence rate difference|-0.39|||||2-Sided|95.0|-1.33|0.56|||||||
1663223|NCT01494038|3060452|Superiority||Incidence rate difference|-1.43|||||2-Sided|95.0|-4.17|1.32|||||||
1663224|NCT01494038|3060453|Superiority||Incidence rate difference|0.02|||||2-Sided|95.0|-1.02|1.07|||||||
1663225|NCT01494038|3060454|Superiority||Incidence rate difference|0.01|||||2-Sided|95.0|-0.94|0.96|||||||
1663226|NCT01494038|3060455|Superiority|||||||0.893|||||||Fisher Exact|mid-P adjustment|||
1663229|NCT01494038|3060460|Superiority|||||||0.264|||||||Fisher Exact|mid-P adjustment|||
1663230|NCT01494038|3060461|Superiority|||||||0.073|||||||Fisher Exact|mid-P adjustment|||
1663231|NCT01494038|3060462|Superiority|||||||0.288|||||||Fisher Exact|mid-P adjustment|||
1663232|NCT01494038|3060464|Superiority|||||||0.093|||||||Fisher Exact|mid-P adjustment|||
1663233|NCT01494038|3060465|Non-Inferiority|Calculate the difference between the immediate arm incidence rate and the deferred arm incidence rate; if the upper bound of the 95% confidence interval is lower than a 5% difference in incidence rates, non-inferiority will be considered to be proven.|Incidence rate difference|0.1|||||2-Sided|95.0|-4.77|4.98|||||||
1663234|NCT01493687|3060489|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1663235|NCT01493687|3060490|Superiority or Other||Mean Difference (Net)|-8.13|||<|0.001|2-Sided|95.0|-10.12|-6.13|||ANCOVA||||
1663236|NCT01493687|3060491|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1663237|NCT01493557|3060492|Superiority or Other||Mean Difference (Final Values)|20.2|||||2-Sided|95.0|-8.2|48.5|||||Mean difference = (Mean number of days for Pradaxa w/meal) − (Mean number of days for pantoprazole).|Mean difference for Time to first complete effectiveness. Partial effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.|
1663238|NCT01493557|3060492|Superiority or Other||Mean Difference (Final Values)|1.4|||||2-Sided|95.0|-3.5|6.3|||||Mean difference = (Mean number of days for Pradaxa w/meal) − (Mean number of days for pantoprazole).|Mean difference for Time to first complete effectiveness. Complete effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.|
1663239|NCT01493557|3060492|Superiority or Other||Mean Difference (Final Values)|-0.5|||||2-Sided|95.0|-9.9|8.9|||||Mean difference = (Mean number of days for Pradaxa w/meal) − (Mean number of days for pantoprazole).|Mean difference for the Duration of gastrointestinal symptoms (GIS).|
1663240|NCT01493557|3060496|Superiority or Other||Mean Difference (Final Values)|-5.71||||1|2-Sided|95.0|-41.25|28.77|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.|
1663241|NCT01493557|3060497|Superiority or Other||Mean Difference (Final Values)|3.81||||1|2-Sided|95.0|-32.94|40.44|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.|
1663242|NCT01493557|3060498|Superiority or Other||Mean Difference (Final Values)|-9.52||||0.7104|2-Sided|95.0|-44.22|28.4|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.|
1663243|NCT01493557|3060499|Superiority or Other||Mean Difference (Final Values)|18.41||||0.0273|2-Sided|95.0|0.71|35.98|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.|
1663244|NCT01493557|3060500|Superiority or Other||Mean Difference (Final Values)|7.1||||0.3165|2-Sided|95.0|-11.24|24.58|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.|
1663245|NCT01493557|3060501|Superiority or Other||Mean Difference (Final Values)|11.31||||0.2554|2-Sided|95.0|-6.54|29.49|||Fisher Exact||Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.|Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.|
1663246|NCT01493531|3060502|Superiority or Other||Risk Difference (RD)|-0.06||||0.6301|2-Sided|95.0|-0.29|0.17|||Cochran-Mantel-Haenszel||||
1663247|NCT01493531|3060502|Superiority or Other||Risk Difference (RD)|-0.02||||0.8466|2-Sided|95.0|-0.24|0.2|||Cochran-Mantel-Haenszel||||
1663248|NCT01493531|3060503|Superiority or Other||Risk Ratio (RR)|0.93||||0.7454|2-Sided|95.0|0.6|1.45|||Negative Binomial Regression||||
1663249|NCT01493531|3060503|Superiority or Other||Risk Ratio (RR)|0.88||||0.5716|2-Sided|95.0|0.57|1.37|||Negative Binomial Regression||||
1663250|NCT01493531|3060504|Superiority or Other||Risk Difference (RD)|0.43|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|0.34|0.52|||Cochran-Mantel-Haenszel||||
1663251|NCT01493531|3060504|Superiority or Other||Risk Difference (RD)|0.32|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|0.23|0.41|||Cochran-Mantel-Haenszel||||
1663252|NCT01493180|3060518|Superiority or Other|||||||0.576|||||||t-test, 2 sided||||
1663253|NCT01493089|3060520|Superiority or Other||Mean Difference (Final Values)|-3.4||||0.69|2-Sided|95.0|-16.4|9.6|||Regression, Cox|||Sustained total relief|
1663254|NCT01493089|3060520|Superiority or Other||Mean Difference (Final Values)|-2.8||||0.751|2-Sided|95.0|-14.7|9.1|||Regression, Cox|||Sustained response|
1663255|NCT01493089|3060520|Superiority or Other||Mean Difference (Final Values)|2.4||||0.494|2-Sided|95.0|-6.3|11.2|||Regression, Cox|||Sustained partial response|
1663256|NCT01493089|3060521|Superiority or Other||Mean Difference (Final Values)|0.9||||0.794|2-Sided|95.0|-11.2|13.1|||Regression, Cox|||Sustained total relief|
1663257|NCT01493089|3060521|Superiority or Other||Mean Difference (Final Values)|-4.7||||0.518|2-Sided|95.0|-17.6|8.2|||Regression, Cox|||Sustained response|
1663258|NCT01493089|3060521|Superiority or Other||Mean Difference (Final Values)|-4.0||||0.501|2-Sided|95.0|-15.0|7.0|||Regression, Cox|||Sustained partial response|
1663259|NCT01493089|3060522|Superiority or Other||Mean Difference (Final Values)|6.8||||0.194|2-Sided|95.0|-3.6|17.2|||Regression, Cox|||Sustained total relief|
1663260|NCT01493089|3060522|Superiority or Other||Mean Difference (Final Values)|-2.2||||0.755|2-Sided|95.0|-15.0|10.6|||Regression, Cox|||Sustained response|
1663261|NCT01493089|3060522|Superiority or Other||Mean Difference (Final Values)|2.8||||0.625||95.0|-9.7|15.3|||Regression, Cox|||Sustained partial response|
1663262|NCT01493089|3060523|Superiority or Other||Hazard Ratio (HR)|1.14||||0.457|2-Sided|95.0|||||Regression, Cox||||
1663263|NCT01493089|3060524|Superiority or Other||Hazard Ratio (HR)|0.903||||0.712||95.0|||||Regression, Cox||||
1663264|NCT01493089|3060525|Superiority or Other||Hazard Ratio (HR)|1.097||||0.563||95.0|||||Regression, Cox||||
1663265|NCT01492582|3060554|Superiority|||||||0.45|||||||Fisher Exact|||Systemic - Dizziness Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5|
1663266|NCT01492582|3060554|Superiority|||||||0.28|||||||Chi-squared, Corrected|||Systemic - Fever Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5|
1663267|NCT01492582|3060554|Superiority|||||||0.07|||||||Chi-squared, Corrected|||Systemic - Headache Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5|
1663268|NCT01492582|3060554|Superiority||||||<|0.001|||||||Chi-squared, Corrected|||Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea; Systemic - Fatigue Historical Healthy Population - As reported by Moreira et. al, 2016, Pediatrics, Table 5|
1663269|NCT01492582|3060554|Superiority||||||<|0.48|||||||Chi-squared, Corrected|||Systemic - Dizziness Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6|
1663270|NCT01492582|3060554|Superiority||||||<|0.03|||||||Chi-squared, Corrected|||Systemic - Fever Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6|
1663271|NCT01492582|3060554|Superiority||||||<|0.001|||||||Chi-squared, Corrected|||Injection site - Pain, any; Injection site - Swelling, any; Injection site - Erythema, any; Systemic - Nausea Historical Healthy Population: Reported from Gardasil Package Insert 04/2015, Tables 1, 2, 5, and 6|
1663272|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|-0.44|||||2-Sided|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663273|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|1.65|||||2-Sided|||||||||"Historical Healthy Population Reference:~NONAVALENT~Men 16-26:~Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892-6901. (HM data)."|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663274|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|1.1|||||2-Sided|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663275|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|1.39|||||2-Sided|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663276|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|1.61|||||2-Sided|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663277|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|1.46|||||2-Sided|||||||||"Historical Healthy Population Reference:~NONAVALENT~Men 16-26:~Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892-6901. (HM data)."|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663278|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|1.12|||||2-Sided|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663309|NCT01492439|3060571|Superiority or Other|||||||0.269||||||This applies to the total of trials 1-4 (total free recall) of the CVLT.|ANCOVA||||
1663310|NCT01492439|3060571|Superiority or Other|||||||0.139||||||This applies to the 'trial 1' subtest of the CVLT.|ANCOVA||||
1663311|NCT01492439|3060572|Superiority or Other|||||||0.669||||||This applies to the 'long delay free recall' subtest of the CVLT.|ANCOVA||||
1663279|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI GMT ratio|1.23|||||2-Sided|||||||||"Historical Healthy Population Reference:~NONAVALENT~Girls 9-15, Boys 9-15, Women 16-26:~Petersen LK, Restrepo J, Moreira ED, Jr., et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Res. 2017;3:105-115;"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663280|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|1.0|||||2-Sided|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663281|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|2.48|||||2-Sided|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663282|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|1.48|||||2-Sided|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663283|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|1.52|||||2-Sided|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663284|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|1.0|||||2-Sided|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663285|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|2.15|||||2-Sided|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663286|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|1.76|||||2-Sided|||||||||"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)
1663287|NCT01492582|3060555|Non-Inferiority|Non-inferiority required that the lower bound of the one-sided 99.688% confidence interval (CI) of the geometric mean titer (GMT) ratio was >0.5.|lower bound one-sided CI of GMT ratio|1.74|||||1-Sided||||||||GMT ratio = GMT (cancer survivor) / GMT (historical healthy population)|"Historical Healthy Population Reference:~QUADRIVALENT~Male and female, all age groups:~Merck Pub 9883616 (Gardasil Package Insert, April 2011, pp 24-26)"|
1663288|NCT01492439|3060557|Superiority or Other|||||||0.468|||||||ANCOVA|||This applies to the total time taken to complete the DVT.|
1663289|NCT01492439|3060558|Superiority or Other|||||||0.853|||||||ANCOVA|This applies to the total number of errors on the DVT.|||
1663290|NCT01492439|3060559|Superiority or Other|||||||0.004|||||||ANCOVA|||This applies to the total time taken to complete the DVT.|
1663291|NCT01492439|3060560|Superiority or Other|||||||0.129||||||This applies to the total number of errors made on the DVT.|ANCOVA||||
1663292|NCT01492439|3060561|Superiority or Other|||||||0.843|||||||ANCOVA|||This applies to the total number of categories on the WCST.|
1663293|NCT01492439|3060562|Superiority or Other|||||||0.926||||||This applies to the percentage of conceptual level responses on the WCST.|ANCOVA||||
1663294|NCT01492439|3060562|Superiority or Other|||||||0.156||||||This applies to the percentage of perseverative errors on the WCST.|ANCOVA||||
1663295|NCT01492439|3060563|Superiority or Other|||||||0.612||||||This applies to the total number of correct categories on the WCST|ANCOVA||||
1663296|NCT01492439|3060564|Superiority or Other|||||||0.637||||||This applies to the percentage of conceptual level responses on the WCST.|ANCOVA||||
1663297|NCT01492439|3060564|Superiority or Other|||||||0.852||||||This applies to the percentage of perseverative errors on the WCST.|ANCOVA||||
1663298|NCT01492439|3060565|Superiority or Other|||||||0.527|||||||ANCOVA||||
1663299|NCT01492439|3060566|Superiority or Other|||||||0.267|||||||ANCOVA||||
1663300|NCT01492439|3060567|Superiority or Other|||||||0.171||||||This applies to the total score (forward + backwards) on the Digit Span Test.|ANCOVA||||
1663301|NCT01492439|3060567|Superiority or Other|||||||0.091||||||This applies to the 'backwards' sequence of the Digit Span Test.|ANCOVA||||
1663302|NCT01492439|3060567|Superiority or Other|||||||0.802||||||This applies to the 'forward' sequence of the Digit Span Test.|ANCOVA||||
1663303|NCT01492439|3060568|Superiority or Other|||||||0.531||||||This applies to the total score (forward+backwards) on the Digit Span Test.|ANCOVA||||
1663304|NCT01492439|3060568|Superiority or Other|||||||0.518||||||This applies to the 'backward' sequence of the Digit Span Test.|ANCOVA||||
1663305|NCT01492439|3060568|Superiority or Other|||||||0.754||||||This applies to the 'forward' sequence of the Digit Span Test.|ANCOVA||||
1663306|NCT01492439|3060569|Superiority or Other|||||||0.958|||||||ANCOVA||||
1663307|NCT01492439|3060570|Superiority or Other|||||||0.391|||||||ANCOVA||||
1663308|NCT01492439|3060571|Superiority or Other|||||||0.666||||||This applies to the 'long delay free recall' subtest of the CVLT.|ANCOVA||||
1663312|NCT01492439|3060572|Superiority or Other|||||||0.242||||||This applies to the total score of trials 1-4 (total free recall) of the CVLT.|ANCOVA||||
1663313|NCT01492439|3060572|Superiority or Other|||||||0.314||||||This applies to Trial 1 on the CVLT.|ANCOVA||||
1663314|NCT01492439|3060573|Superiority or Other|||||||0.008|||||||ANCOVA||||
1663315|NCT01492439|3060574|Superiority or Other|||||||0.639||||||This applies to the 'general psychopathology' subscale of the PANSS.|ANCOVA||||
1663316|NCT01492439|3060574|Superiority or Other|||||||0.027||||||This applies to the 'negative' subscale of the PANSS.|ANCOVA||||
1663317|NCT01492439|3060574|Superiority or Other|||||||0.95||||||This applies to the 'positive' subscale of the PANSS.|ANCOVA||||
1663318|NCT01492439|3060575|Superiority or Other|||||||0|||||||ANCOVA||||
1663319|NCT01492439|3060576|Superiority or Other|||||||0.582||||||This applies to the 'general psychopathology' subscale of the PANSS.|ANCOVA||||
1663320|NCT01492439|3060576|Superiority or Other|||||||0.747||||||This applies to the 'negative' subscale of the PANSS.|ANCOVA||||
1663321|NCT01492439|3060576|Superiority or Other|||||||0.247||||||This applies to the 'positive' subscale of the PANSS.|ANCOVA||||
1663322|NCT01492439|3060577|Superiority or Other|||||||0.225||||||This applies to semester 2.|t-test, 1 sided||||
1663323|NCT01492439|3060577|Superiority or Other|||||||0.029||||||This applies to Semester 1.|t-test, 1 sided||||
1663324|NCT01492426|3060583|Non-Inferiority or Equivalence|Test of noninferiority was based on noninferiority margin of -12% and 2-sided alpha level of 5%. That is, if the lower bound of the 95% CI > -12%, the Daclatasvir arm would be considered nonnferior to the telaprevir arm.|Percentage difference|4.3|Standard Deviation|3.885|||2-Sided|95.0|-3.3|11.9||||||Percentage difference between SVR12 rate in the experimental and control arms was computed using a stratum-adjusted Mantel-Haenszel confidence interval (95% level) for the difference in rates. The stratification factors were IL28B rs1297860 single nucleotide polymorphism (CC or non-CC) and baseline cirrhosis status (absent or present), unless otherwise indicated.|
1663325|NCT01492309|3060587|Superiority|||||||0.425|||||||Regression, Logistic|||This analysis is based on a mixed model that can handle missing data.|
1663326|NCT01492309|3060588|Superiority|||||||0.003|||||||Fisher Exact|||This analysis is based on a mixed model that can handle missing data.|
1663327|NCT01491802|3060652|Superiority|||||||0.028|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.|
1663328|NCT01491802|3060653|Superiority|||||||0.944|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.|
1663329|NCT01491802|3060654|Superiority|||||||0.96|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.|
1663330|NCT01491802|3060655|Superiority|||||||0.573|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.|
1663331|NCT01491802|3060656|Superiority|||||||0.044|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.|
1663332|NCT01491802|3060657|Superiority|||||||0.006|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.|
1663333|NCT01491802|3060658|Superiority|||||||0.197|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.|
1663334|NCT01491802|3060659|Superiority|||||||0.68|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.|
1663335|NCT01491802|3060660|Superiority|||||||0.09|||||||t-test, 2 sided|||A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.|
1663336|NCT01491737|3060665|Superiority or Other (legacy)||Hazard Ratio (HR)|1.11||||0.5597|2-Sided|95.0|0.78|1.57||Median and log-rank test from unstratified analysis based upon Kaplan-Meier approach. 95% CI for medians are determined using the log-log transformation.|Log Rank||Hazard ratio from stratified Cox proportional hazards model including stratification factors from IXRS.||
1663337|NCT01491737|3060666|Superiority or Other (legacy)||Hazard Ratio (HR)|0.57||||0.0181|2-Sided|95.0|0.36|0.91||Median and log-rank test from unstratified analysis based upon Kaplan-Meier approach. 95% confidence interval (CI) for medians are determined using the log-log transformation.|Log Rank||Hazard ratio from stratified Cox proportional hazards model including stratification factors from IXRS.||
1663338|NCT01491737|3060667|Superiority or Other (legacy)||Hazard Ratio (HR)|1.15||||0.585|2-Sided|95.0|0.69|1.91||Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant therapy stratification factors from interactive response system (IXRS).|Log Rank||Hazard ratio from stratified Cox proportional hazards model including stratification factors from IXRS.||
1663339|NCT01491737|3060668|Superiority or Other (legacy)||Hazard Ratio (HR)|0.65||||0.007|2-Sided|95.0|0.48|0.89||Stratified log-rank test based upon Kaplan-Meier including induction chemotherapy and prior adjuvant therapy stratification factors from interactive response system (IXRS).|Log Rank||Hazard ratio from stratified Cox proportional hazards model including stratification factors from IXRS.||
1663340|NCT01490931|3060732|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.|
1663341|NCT01490931|3060733|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.|
1663364|NCT01488578|3061059|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1663365|NCT01488578|3061060|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1663366|NCT01488578|3061061|Superiority or Other||||||=|0|||||||Chi-squared||||
1663342|NCT01490931|3060734|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.|
1663343|NCT01490931|3060735|Superiority or Other||||||<|1|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.|
1663344|NCT01490931|3060736|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.|
1663345|NCT01490931|3060737|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.|
1663346|NCT01490931|3060738|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.|
1663347|NCT01490931|3060739|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.|
1663348|NCT01490931|3060743|Superiority or Other||||||<|0.0001||||||P value adjusted with Bonferroni corrections for multiple comparisons|t-test, 2 sided|||Changes in pain intensity on the VAS were statistically compared to baseline pain utilizing paired t tests with Bonferroni corrections for multiple comparisons. The median onsets of first perceptible and meaningful relief (with 95% confidence intervals) were calculated and then used to construct Kaplan-Meier Curves of the distribution of pain relief times.|
1663349|NCT01490840|3060760|Non-Inferiority or Equivalence|A sample size of 90 in each group would have 80% power to detect a difference in means of 3.8, assuming that the common standard deviation is 9.05, using a two group t-test with a 0.05 2-sided significance level.|Mean Difference (Net)|-1.47||||0.4579|2-Sided|95.0|-5.39|2.44|||ANCOVA||||
1663350|NCT01490697|3060773|Superiority||Mean Difference (Net)|3.9|||||2-Sided|95.0|-6.9|14.7|||||Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)||
1663351|NCT01490697|3060774|Superiority||Mean Difference (Final Values)|-1.0|||||2-Sided|95.0|-18.0|16.0|||||Placebo plus Placebo - Mifepristone plus d-Cycloserine (DCS)||
1663352|NCT01490580|3060810|Superiority||Risk Difference (RD)|-6.4||||0.38|2-Sided|95.0|-21.0|8.1|||Mixed Models Analysis||||
1663353|NCT01490359|3060818|Superiority or Other||Odds Ratio (OR)|1.32||||0.008|2-Sided|95.0|1.03|1.71||The GEE model included baseline measure of consistent condom use, intervention condition, time (6- vs. 12-mo follow-up), and type of partner (steady vs casual partners) with robust standard errors and an independent working correlation matrix.|generalized estimating equations (GEE)||Estimate is odds ratio (intervention vs. health control).|Assuming alpha = 0.05, a 2-tailed test, ICC = 0.01, 15% attrition at 12-month follow-up, and N = 1,152 men in the trial from 44 neighborhoods with an average of 26 men in each neighborhood, the trial was estimated to have 81% power to detect a 10% increase in consistent condom use from 32% to 42% in the HIV/STI intervention group.|
1663354|NCT01489891|3060925|Non-Inferiority or Equivalence|Beta 0.1; Alpha 0.05|Median Difference (Final Values)|30.6|Standard Deviation|42.1|<|0.05|2-Sided|95.0|||||t-test, 2 sided||||
1663355|NCT01489254|3060968|Non-Inferiority or Equivalence|To conclude equivalence between Glatiramer 20 mg and Copaxone 20 mg, efficacy in the combined active treatment groups needed to be superior to placebo (confirming study sensitivity) and the 2-sided 95% CI for the estimated ratio of Glatiramer 20 mg to Copaxone 20 mg needed to be fully enclosed in the prespecified equivalence margin (0.727 - 1.375).|Ratio (or Ratio of estimated means)|1.095|||||2-Sided|95.0|0.883|1.36|||||Ratio of Glatiramer 20 mg to Copaxone 20 mg and 95% confidence interval.|Estimates represent the mean total lesions during months 7 through 9 and were estimated from the fitted random effect generalized linear model (longitudinal model) with a negative binomial distribution and logaritmic link function including Glatiramer 20 mg and Copaxone 20 mg treatment groups to assess study equivalence.|
1663356|NCT01489254|3060968|Non-Inferiority or Equivalence|To conclude study sensitivity the combined active treatment groups Glatiramer 20 mg and Copaxone 20 mg needed to be superior to placebo.|Ratio (or Ratio of estimated means)|0.488|||||2-Sided|95.0|0.365|0.651|||||Ratio of combined Glatiramer 20 mg + Copaxone 20 mg to placebo and 95% confidence interval.|Estimates represent the mean total lesions during months 7 through 9 and were estimated from the fitted random effect generalized linear model (longitudinal model) with a negative binomial distribution and logaritmic link function. To assess study sensitivity, data of the active treatment groups and placebo were included in the model, resulting in the ratios and 95% CIs for the combined Glatiramer 20 mg and Copaxone 20 mg treatment group and the individual treatments over placebo.|
1663357|NCT01488578|3061051|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1663358|NCT01488578|3061052|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1663359|NCT01488578|3061053|Superiority or Other||||||=|0|||||||Chi-squared||||
1663360|NCT01488578|3061054|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1663361|NCT01488578|3061055|Superiority or Other||||||=|0|||||||Chi-squared||||
1663362|NCT01488578|3061057|Superiority or Other||||||<|0.001|||||||The Hosmer-Lemeshow Goodness-of-Fit TEST||||
1663363|NCT01488578|3061058|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1663367|NCT01488578|3061064|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1663368|NCT01488448|3061070|Superiority or Other|||||||0.96|||||||Wilcoxon (Mann-Whitney)||||
1663369|NCT01488448|3061073|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)||||
1663370|NCT01488448|3061074|Superiority or Other|||||||0.39|||||||Wilcoxon (Mann-Whitney)||||
1663371|NCT01488448|3061075|Superiority or Other|||||||0.67|||||||Fisher Exact||||
1663372|NCT01488448|3061076|Superiority or Other|||||||0.97|||||||Fisher Exact||||
1663373|NCT01488448|3061077|Superiority or Other|||||||0.77|||||||Fisher Exact||||
1663374|NCT01488448|3061078|Superiority or Other|||||||0.73|||||||Wilcoxon (Mann-Whitney)||||
1663375|NCT01488409|3061079|Superiority or Other|||||||0.007|||||||t-test, 2 sided||||
1663376|NCT01488409|3061080|Superiority or Other|||||||0.79|||||||t-test, 2 sided||||
1663377|NCT01488409|3061081|Superiority or Other|||||||0.52|||||||t-test, 2 sided||||
1663378|NCT01488409|3061082|Superiority or Other|||||||0.85|||||||t-test, 2 sided||||
1663379|NCT01488409|3061083|Superiority or Other|||||||0.97|||||||t-test, 2 sided||||
1663380|NCT01488279|3061093|Superiority||Mean Difference (Net)|-38.9|Standard Error of the Mean|49.9||0.46|2-Sided|95.0|-156.9|79.0|||ANOVA||||
1663381|NCT01488279|3061094|Superiority||Mean Difference (Net)|-0.008|Standard Error of the Mean|1.935||0.997|2-Sided|95.0|-4.585|4.568|||ANOVA||||
1663382|NCT01488279|3061097|Superiority||Mean Difference (Net)|-10.8|Standard Error of the Mean|480.8||0.983|2-Sided|95.0|-1147.6|1126.0|||ANOVA|||2X2 crossover design with baseline values. To compare the means between Sitagliptin and Placebo, a sequential three step testing process used. The results of the third step, the direct treatment comparisons are presented.|
1663383|NCT01488071|3061110|Superiority or Other||Mean Difference (Final Values)|-1.75|Standard Error of the Mean|0.75||0.0209|2-Sided|95.0|-3.23|-0.27||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.|||
1663384|NCT01488071|3061111|Superiority or Other||Mean Difference (Final Values)|-2.22|Standard Error of the Mean|0.72||0.0021|2-Sided|95.0|-3.63|-0.81||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.|||
1663385|NCT01488071|3061112|Superiority or Other||Odds Ratio (OR)|2.01||||0.0002|2-Sided|95.0|1.39|2.9||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic||||
1663386|NCT01488071|3061113|Superiority or Other||Odds Ratio (OR)|1.72||||0.0054|2-Sided|95.0|1.17|2.52||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic||||
1663387|NCT01488071|3061114|Superiority or Other||Odds Ratio (OR)|1.83||||0.0014|2-Sided|95.0|1.26|2.65||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic||||
1663388|NCT01488071|3061115|Superiority or Other||Odds Ratio (OR)|1.81||||0.0012|2-Sided|95.0|1.26|2.6||Wald's Test. No adjustments for multiple comparisons were made.|Regression, Logistic||||
1663389|NCT01488071|3061116|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.09||0.0055|2-Sided|95.0|-0.42|-0.07||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.|||
1663390|NCT01488071|3061117|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.09||0.0048|2-Sided|95.0|-0.42|-0.08||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.|||
1663391|NCT01488071|3061118|Superiority or Other||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.1||0.0075|2-Sided|95.0|-0.47|-0.07||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.|||
1663392|NCT01488071|3061119|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0023|2-Sided|95.0|-0.48|-0.11||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.|||
1663393|NCT01488071|3061120|Superiority or Other||Mean Difference (Final Values)|-1.93|Standard Error of the Mean|0.57||0.0007|2-Sided|95.0|-3.04|-0.81||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.|||
1663394|NCT01488071|3061121|Superiority or Other||Mean Difference (Final Values)|-1.89|Standard Error of the Mean|0.56||0.0008|2-Sided|95.0|-2.98|-0.8||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.|||
1663395|NCT01488071|3061122|Superiority or Other||Mean Difference (Final Values)|-2.03|Standard Error of the Mean|0.72||0.0054|2-Sided|95.0|-3.45|-0.6||No adjustments for multiple comparisons were made.|Mixed Models Analysis|The same MMRM methodology as for the primary endpoint was used.|||
1663396|NCT01488071|3061123|Non-Inferiority or Equivalence|"Mixed model for repeated measurements (MMRM), using all available data, with a freely varying mean and covariance structures and with treatment, week, and site group as fixed factors and the baseline score as a covariate. The model also included interaction between week and baseline score, as well as interaction between week and treatment.~Non-inferiority, upper limit of Confidence Interval should not exceed 2."|Mean Difference (Final Values)|-2.16|Standard Error of the Mean|0.69||0.0018|2-Sided|95.0|-3.51|-0.81||Under established non-inferiority the p-value is not adjusted.|Mixed Models Analysis|MMRM|||
1663397|NCT01488019|3061137|Non-Inferiority|The hazard ratio and 90% two-sided confidence interval for the hazard ratio comparing Perforomist to placebo were estimated. Non-inferiority was declared if the upper limit of the two-sided 90% confidence interval was wholly less than 1.5.|Hazard Ratio (HR)|0.965|||||2-Sided|90.0|0.711|1.308|||||Hazard Ratio was calculated as Perforomist Inhalation Solution vs Placebo. The non-inferiority margin for the hazard ratio is 1.5.||
1663398|NCT01487863|3061140|Superiority|||||||0.2141|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test.|||
1663399|NCT01487161|3061181|Superiority||Mean Difference (Final Values)|0.1||||0.5541|2-Sided|90.0|-0.7|0.8|||Longitudinal mixed effect model||||
1663400|NCT01487161|3061182|Superiority||Mean Difference (Final Values)|-0.4||||0.2002|2-Sided|90.0|-1.1|0.3|||Longitudinal mixed effect model||||
1663401|NCT01487161|3061183|Superiority||Mean Difference (Final Values)|-0.5||||0.1249|2-Sided|90.0|-1.2|0.2|||Longitudinal mixed effect model||||
1663402|NCT01486927|3061213|Superiority or Other||Rate ratio|0.08|||<|0.0001|2-Sided|95.0|0.07|0.1|||Poisson, regression|||A test of the null hypothesis of no difference on AsBR between the 2 comparison groups was based on the Poisson Regression method. The corresponding prophylaxis/on-demand ratio with 95% confidence interval (CI) was calculated.|
1663403|NCT01486758|3061221|Superiority or Other|||||||0.048|||||||Log Rank||||
1663404|NCT01486758|3061225|Superiority or Other|||||||0.6|||||||ANCOVA||||
1663405|NCT01486264|3061257|Non-Inferiority|Analysis of covariance (ANCOVA) model adjusted for the baseline TWSTRS Severity subscale score, was used to test the non-inferiority of Short Flex versus Long Flex treatment. Non-inferiority margin delta equal to (=) 2 points.|Least Square (LS) Mean difference|-1.4|Standard Error of the Mean|0.75|||2-Sided|95.0|-2.9|0.1|||||||
1663406|NCT01486199|3061261|Equivalence|alpha=0.05||||||0.87|||||||Wilcoxon (Mann-Whitney)|||Comparing mucociliary clearance at t=0 and t=2yrs in pediatric CF subjects|
1663407|NCT01486199|3061262|Equivalence|alpha=0.05||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Comparing absorptive clearance at t=0 vs t=2 years in pediatric CF subjects|
1663408|NCT01486199|3061263|Equivalence|alpha = 0.05||||||0.2|||||||t-test, 2 sided|||Comparison of mucociliary clearance in CF children compared to healthy adults|
1663409|NCT01486199|3061264|Equivalence|alpha=0.05||||||0.002|||||||t-test, 2 sided|||Comparing absorptive clearance in CF children vs adult controls|
1663410|NCT01485991|3061270|Superiority or Other||Difference in proportions|-1.1||||0.001|2-Sided|95.0|-7.8|5.5||based on the asymptotic distribution of the generalized Cochran-Mantel-Haenszel statistic controlling for stratification factors, using a non-inferiority margin of 12 percent|Stratified Cochran-Mantel-Haenszel||||
1663411|NCT01485627|3061297|Superiority|||||||0.19|||||||Mixed Models Analysis||||
1663412|NCT01485627|3061298|Superiority|||||||0.677|||||||Mixed Models Analysis||||
1663413|NCT01485627|3061300|Superiority||Mean Difference (Final Values)|-0.09||||0.05|2-Sided|95.0|-0.56|0.37|||Mixed Models Analysis||||
1663414|NCT01485627|3061301|Superiority|||||||0.214|||||||Mixed Models Analysis||||
1663415|NCT01485627|3061302|Superiority||Adjusted mean difference in difference|0.34||||0.05|2-Sided|95.0|0.06|0.62|||Mixed Models Analysis||Models included fixed-effects terms for phase (pre- vs postrandomization), study arm, and the Phase*Arm interaction. Estimated effect is the between-arm difference in adjusted mean difference from prerandomization to postrandomization samples.|The primary outcome was a composite of 4 prespecified communication measures matched to the goals of communication training, as follows: Active Patient Participation Coding [APPC], Verona VR-CoDES, Prognostic and Treatment Choices [PTCC] Informing subscale, and PTCC Balanced Framing subscale. The 4 measures were z-score transformed and averaged to produce the composite measure.|
1663416|NCT01485172|3061314|Superiority or Other||Odds Ratio (OR)|1.281||||0.752|2-Sided|95.0|0.27|5.98|||Generalized Estimating Equations model||||
1663417|NCT01485172|3061314|Superiority or Other||Odds Ratio (OR)|5.456||||0.001|2-Sided|95.0|1.93|15.46|||Generalized Estimating Equations model||||
1663418|NCT01485172|3061314|Superiority or Other||Odds Ratio (OR)|4.204||||0.008|2-Sided|95.0|1.46|12.07|||Generalized Estimating Equations model||||
1663419|NCT01485172|3061314|Superiority or Other||Odds Ratio (OR)|1.411||||0.519|2-Sided|95.0|0.5|4.02|||Generalized Estimating Equations model||||
1663420|NCT01485172|3061314|Superiority or Other||Odds Ratio (OR)|0.769||||0.733|2-Sided|95.0|0.17|3.49|||Generalized Estimating Equations model||||
1663421|NCT01485172|3061315|Superiority or Other||Mean Difference (Final Values)|0.45||||0.086|2-Sided|95.0|-0.06|0.97||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663422|NCT01485172|3061315|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.697|2-Sided|95.0|-0.42|0.28||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663423|NCT01485172|3061315|Superiority or Other||Mean Difference (Final Values)|-0.31||||0.084|2-Sided|95.0|-0.66|0.04||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663424|NCT01485172|3061315|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.723|2-Sided|95.0|-0.41|0.29||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663425|NCT01485172|3061315|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.102|2-Sided|95.0|-0.86|0.08||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663426|NCT01485172|3061316|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.811|2-Sided|95.0|-6.08|4.77||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663427|NCT01485172|3061316|Superiority or Other||Mean Difference (Final Values)|-3.94||||0.04|2-Sided|95.0|-7.7|-0.18||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663428|NCT01485172|3061316|Superiority or Other||Mean Difference (Final Values)|-3.19||||0.101|2-Sided|95.0|-7.01|0.63||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663429|NCT01485172|3061316|Superiority or Other||Mean Difference (Final Values)|-1.09||||0.568|2-Sided|95.0|-4.86|2.68||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663430|NCT01485172|3061316|Superiority or Other||Mean Difference (Final Values)|0.56||||0.823|2-Sided|95.0|-4.38|5.5||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663431|NCT01485172|3061317|Superiority or Other||Mean Difference (Final Values)|-0.73||||0.456|2-Sided|95.0|-2.67|1.2||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663432|NCT01485172|3061317|Superiority or Other||Mean Difference (Final Values)|-1.01||||0.117|2-Sided|95.0|-2.27|0.25||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663433|NCT01485172|3061317|Superiority or Other||Mean Difference (Final Values)|-0.87||||0.163|2-Sided|95.0|-2.1|0.36||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663434|NCT01485172|3061317|Superiority or Other||Mean Difference (Final Values)|-0.47||||0.446|2-Sided|95.0|-1.71|0.76||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663435|NCT01485172|3061317|Superiority or Other||Mean Difference (Final Values)|1.17||||0.158|2-Sided|95.0|-0.46|2.81||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663436|NCT01485172|3061318|Superiority or Other||Mean Difference (Final Values)|-0.99||||0.715|2-Sided|95.0|-6.32|4.35||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663437|NCT01485172|3061318|Superiority or Other||Mean Difference (Final Values)|-3.74||||0.048|2-Sided|95.0|-7.43|-0.04||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663438|NCT01485172|3061318|Superiority or Other||Mean Difference (Final Values)|-2.75||||0.15|2-Sided|95.0|-6.5|1.01||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663439|NCT01485172|3061318|Superiority or Other||Mean Difference (Final Values)|-0.93||||0.621|2-Sided|95.0|-4.63|2.77||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663440|NCT01485172|3061318|Superiority or Other||Mean Difference (Final Values)|1.07||||0.662|2-Sided|95.0|-3.78|5.93||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663441|NCT01485172|3061319|Superiority or Other||Odds Ratio (OR)|2.506||||0.221|2-Sided|95.0|0.58|10.9|||Generalized Estimating Equations model||||
1663442|NCT01485172|3061319|Superiority or Other||Odds Ratio (OR)|2.96||||0.045|2-Sided|95.0|1.02|8.55|||Generalized Estimating Equations model||||
1663443|NCT01485172|3061319|Superiority or Other||Odds Ratio (OR)|2.391||||0.115|2-Sided|95.0|0.81|7.06|||Generalized Estimating Equations model||||
1663444|NCT01485172|3061319|Superiority or Other||Odds Ratio (OR)|1.473||||0.494|2-Sided|95.0|0.49|4.47|||Generalized Estimating Equations model||||
1663445|NCT01485172|3061319|Superiority or Other||Odds Ratio (OR)|1.591||||0.54|2-Sided|95.0|0.36|7.03|||Generalized Estimating Equations model||||
1663446|NCT01485172|3061321|Superiority or Other||Odds Ratio (OR)|1.194||||0.851|2-Sided|95.0|0.19|7.63|||Generalized Estimating Equations model||||
1663447|NCT01485172|3061321|Superiority or Other||Odds Ratio (OR)|1.776||||0.379|2-Sided|95.0|0.49|6.38|||Generalized Estimating Equations model||||
1663448|NCT01485172|3061321|Superiority or Other||Odds Ratio (OR)|1.855||||0.347|2-Sided|95.0|0.51|6.72|||Generalized Estimating Equations model||||
1663449|NCT01485172|3061321|Superiority or Other||Odds Ratio (OR)|1.485||||0.557|2-Sided|95.0|0.4|5.55|||Generalized Estimating Equations model||||
1663450|NCT01485172|3061321|Superiority or Other||Odds Ratio (OR)|1.544||||0.662||95.0|0.22|10.84|||Generalized Estimating Equations model||||
1663451|NCT01485172|3061322|Superiority or Other||Odds Ratio (OR)|2.679||||0.202|2-Sided|95.0|0.59|12.16|||Generalized Estimating Equations model||||
1663452|NCT01485172|3061322|Superiority or Other||Odds Ratio (OR)|3.607||||0.02||95.0|1.22|10.64|||Generalized Estimating Equations model||||
1663453|NCT01485172|3061322|Superiority or Other||Odds Ratio (OR)|3.515||||0.018|2-Sided|95.0|1.25|9.92|||Generalized Estimating Equations model||||
1663454|NCT01485172|3061322|Superiority or Other||Odds Ratio (OR)|2.242||||0.131|2-Sided|95.0|0.79|6.4|||Generalized Estimating Equations model||||
1663455|NCT01485172|3061322|Superiority or Other||Odds Ratio (OR)|2.003||||0.397|2-Sided|95.0|0.4|9.98|||Generalized Estimating Equations model||||
1663456|NCT01485172|3061323|Superiority or Other|||||||0.407||||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA||||
1663457|NCT01485172|3061323|Superiority or Other|||||||0.047||||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA||||
1663458|NCT01485172|3061323|Superiority or Other|||||||0.06||||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA||||
1663459|NCT01485172|3061323|Superiority or Other|||||||0.177||||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA||||
1663460|NCT01485172|3061323|Superiority or Other|||||||0.439||||||P-values are from nonparametric rank ANCOVA without stratifications.|ANCOVA||||
1663461|NCT01485172|3061323|Superiority or Other||Mean Difference (Final Values)|-0.92||||0.658|2-Sided|95.0|-5.04|3.19||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663462|NCT01485172|3061323|Superiority or Other||Mean Difference (Final Values)|-2.16||||0.124|2-Sided|95.0|-4.93|0.6||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663463|NCT01485172|3061323|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.091|2-Sided|95.0|-5.21|0.39||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663464|NCT01485172|3061323|Superiority or Other||Mean Difference (Final Values)|-0.85||||0.539|2-Sided|95.0|-3.61|1.9||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663465|NCT01485172|3061323|Superiority or Other||Mean Difference (Final Values)|0.33||||0.864|2-Sided|95.0|-3.41|4.05||P-values are from a Mixed Model Repeated Measures analysis.|Mixed Models Analysis||||
1663466|NCT01484977|3061339|Superiority or Other||Retention Rate|73.3|||||2-Sided|95.0|65.42|81.25||||||"Analyses of the primary efficacy variable will be descriptive only. No hypothesis tests are planned.~The number and percentage of subjects remaining in the study through the 21-Week Treatment Period will be calculated. Subjects with retention will be counted in the numerator. All subjects in the relevant population will be used as the denominator.~This percentage will be known as the retention rate, along with the 95 % confidence interval based on the normal approximation."|
1663467|NCT01484912|3061348|Superiority or Other|||||||0.005|||||||t-test, 2 sided|||All hypothesis testing was conducted with T-tests, two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.|
1663468|NCT01484912|3061349|Non-Inferiority or Equivalence|The superiority testing was conducted one sided with 0.025 significance level. If H0 was rejected one-sided 0.025 significance level, STA-2 was concluded to be statistically superior to Placebo.All hypothesis testing except for the primary efficacy endpoint was conducted two sides at 0.05 significance level and 95% Confidence Interval (C.I.) was adopted if needed.||||||0.025|||||||t-test, 1 sided|||T-test was used to compare the change in total exercise time between the treatment groups. The change in total exercise time (△) was defined as the total exercise time at end-point visit minus the total exercise time at baseline. Let △T be the change in total exercise time for treatment group (STA-2) and △C be the change in total exercise time for control group (Placebo). The hypothesis testing for the superiority of STA-2 to Placebo was H0：△T－△C≦0 with H1：△T－△C﹥0.|
1663469|NCT01484561|3061362|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.07||0.003|2-Sided|90.0|0.1|0.35||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663470|NCT01484561|3061363|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.09||0.053|2-Sided|90.0|-0.31|-0.03||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663471|NCT01484561|3061364|Superiority or Other||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.1|<|0.001|2-Sided|90.0|-0.56|-0.23||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663472|NCT01484561|3061365|Superiority or Other||Mean Difference (Final Values)|9.68|Standard Error of the Mean|4.67||0.04|2-Sided|90.0|1.95|17.41||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663473|NCT01484561|3061366|Superiority or Other||Mean Difference (Final Values)|-5.62|Standard Error of the Mean|4.83||0.247|2-Sided|90.0|-13.62|2.38||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663474|NCT01484561|3061367|Superiority or Other||Mean Difference (Final Values)|-15.3|Standard Error of the Mean|4.52|<|0.001|2-Sided|90.0|-22.78|-7.82||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663475|NCT01484561|3061368|Superiority or Other||Mean Difference (Final Values)|12.72|Standard Error of the Mean|4.17||0.003|2-Sided|90.0|5.82|19.62||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663476|NCT01484561|3061369|Superiority or Other||Mean Difference (Final Values)|-2.4|Standard Error of the Mean|4.77||0.616|2-Sided|90.0|-10.3|5.5||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663477|NCT01484561|3061370|Superiority or Other||Mean Difference (Final Values)|-15.12|Standard Error of the Mean|3.9|<|0.001|2-Sided|90.0|-21.58|-8.67||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663478|NCT01484561|3061371|Superiority or Other||Mean Difference (Final Values)|10.19|Standard Error of the Mean|4.42||0.023|2-Sided|90.0|2.87|17.52||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663479|NCT01484561|3061372|Superiority or Other||Mean Difference (Final Values)|-5.7|Standard Error of the Mean|4.95||0.251|2-Sided|90.0|-13.9|2.5||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663480|NCT01484561|3061373|Superiority or Other||Mean Difference (Final Values)|-15.9|Standard Error of the Mean|4.87||0.001|2-Sided|90.0|-23.96|-7.84||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663481|NCT01484561|3061374|Superiority or Other||Mean Difference (Final Values)|4.84|Standard Error of the Mean|2.98||0.107|2-Sided|90.0|-0.1|9.77||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663482|NCT01484561|3061375|Superiority or Other||Mean Difference (Final Values)|-8.89|Standard Error of the Mean|4.04||0.029|2-Sided|90.0|-15.58|-2.21||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663483|NCT01484561|3061376|Superiority or Other||Mean Difference (Final Values)|-13.73|Standard Error of the Mean|3.71|<|0.001|2-Sided|90.0|-19.87|-7.59||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663502|NCT01484561|3061392|Superiority or Other||Ratio of Adjusted Geo Mean-Fold Change|0.97|||||2-Sided|90.0|0.94|1.0|||||ANCOVA with change in logarithmic creatinine from Period 2 baseline/the end of Period 1 as dependent variable, treatment and Period 2 baseline/the end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)|
1663484|NCT01484561|3061377|Superiority or Other||Mean Difference (Final Values)|1.46|Standard Error of the Mean|1.03||0.158|2-Sided|90.0|-0.24|3.15||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663485|NCT01484561|3061378|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|1.11||0.472|2-Sided|90.0|-2.64|1.04||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663486|NCT01484561|3061379|Superiority or Other||Mean Difference (Final Values)|-2.26|Standard Error of the Mean|1.03||0.03|2-Sided|90.0|-3.96|-0.55||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663487|NCT01484561|3061380|Superiority or Other||Mean Difference (Final Values)|4.23|Standard Error of the Mean|1.93||0.03|2-Sided|90.0|1.04|7.42||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663488|NCT01484561|3061381|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|1.76||0.936|2-Sided|90.0|-2.78|3.06||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663489|NCT01484561|3061382|Superiority or Other||Mean Difference (Final Values)|-4.09|Standard Error of the Mean|2.02||0.045|2-Sided|90.0|-7.44|-0.74||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663490|NCT01484561|3061383|Superiority or Other||Mean Difference (Final Values)|0.76|Standard Error of the Mean|0.24||0.002|2-Sided|90.0|0.36|1.15||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663491|NCT01484561|3061384|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.23||0.031|2-Sided|90.0|-0.88|-0.12||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663492|NCT01484561|3061385|Superiority or Other||Mean Difference (Final Values)|-1.26|Standard Error of the Mean|0.25|<|0.001|2-Sided|90.0|-1.67|-0.84||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663493|NCT01484561|3061386|Superiority or Other||Mean Difference (Final Values)|0.68|Standard Error of the Mean|0.22||0.002|2-Sided|90.0|0.32|1.04||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663494|NCT01484561|3061387|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.21||0.028|2-Sided|90.0|-0.83|-0.12||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663495|NCT01484561|3061388|Superiority or Other||Mean Difference (Final Values)|-1.16|Standard Error of the Mean|0.23|<|0.001|2-Sided|90.0|-1.53|-0.78||Two-sided test at 5% significance level.|Mixed Models Analysis||Linear mixed-effects model for longitudinal data was used with actual value as dependent variable, treatment group, visit (baseline, end of Period 1, end of Period 2), treatment group by visit interaction as fixed effect, participant as random effect||
1663496|NCT01484561|3061389|Superiority or Other||Mean Difference (Final Values)|7.32|Standard Error of the Mean|3.53||0.038|2-Sided|90.0|1.51|13.12||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR70 Response at End of Period 2|
1663497|NCT01484561|3061389|Superiority or Other||Mean Difference (Final Values)|18.56|Standard Error of the Mean|3.95|<|0.001|2-Sided|90.0|12.06|25.05||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR70 Response at End of Period 1|
1663498|NCT01484561|3061390|Superiority or Other||Mean Difference (Final Values)|17.0|Standard Error of the Mean|6.13||0.006|2-Sided|90.0|6.92|27.08||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR50 Response at End of Period 2|
1663499|NCT01484561|3061390|Superiority or Other||Mean Difference (Final Values)|21.02|Standard Error of the Mean|5.94|<|0.001|2-Sided|90.0|11.24|30.8||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR50 Response at End of Period 1|
1663500|NCT01484561|3061391|Superiority or Other||Mean Difference (Final Values)|15.95|Standard Error of the Mean|8.14||0.05|2-Sided|90.0|2.56|29.34||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR20 Response at End of Period 2|
1663501|NCT01484561|3061391|Superiority or Other||Mean Difference (Final Values)|36.16|Standard Error of the Mean|7.64|<|0.001|2-Sided|90.0|23.6|48.73||Two-sided test at 5% significance level.|Normal approximation for proportions|||Between-group difference in ACR20 Response at End of Period 1|
1663503|NCT01484561|3061393|Superiority or Other||Ratio of Adjusted Geo Mean-Fold Change|1.01|||||2-Sided|90.0|0.98|1.04|||||ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)|
1663504|NCT01484561|3061394|Superiority or Other||Ratio of Adjusted Geo Mean-Fold Change|1.05|||||2-Sided|90.0|1.02|1.08|||||ANCOVA with change in logarithmic creatinine from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)|
1663505|NCT01484561|3061395|Superiority or Other||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||2-Sided|90.0|1.01|1.07|||||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)|
1663506|NCT01484561|3061396|Superiority or Other||Ratio of Adjusted Geo Mean-Fold Change|0.99|||||2-Sided|90.0|0.97|1.02|||||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)|
1663507|NCT01484561|3061397|Superiority or Other||Ratio of Adjusted Geo Mean-Fold Change|0.95|||||2-Sided|90.0|0.92|0.98|||||ANCOVA with change in logarithmic eGFR (Cockcroft-Gault) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)|
1663508|NCT01484561|3061398|Superiority or Other||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||2-Sided|90.0|1.0|1.08|||||ANCOVA with change in logarithmic eGFR (MDRD) from Period 2 baseline/end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)|
1663509|NCT01484561|3061399|Superiority or Other||Ratio of Adjusted Geo Mean-Fold Change|0.99|||||2-Sided|90.0|0.96|1.02|||||ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)|
1663510|NCT01484561|3061400|Superiority or Other||Ratio of Adjusted Geo Mean-Fold Change|0.94|||||2-Sided|90.0|0.91|0.97|||||ANCOVA with change in logarithmic eGFR (MDRD) from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)|
1663511|NCT01484561|3061401|Superiority or Other||Ratio of Adjusted Geo Mean-Fold Change|1.09|||||2-Sided|90.0|1.02|1.16|||||ANCOVA with change in logarithmic mGFR from Period 2 baseline/the end of Period 1 as dependent variable, treatment and logarithmic Period 2 baseline/the end of Period 1 as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)|
1663512|NCT01484561|3061402|Superiority or Other||Ratio of Adjusted Geo Mean-Fold Change|1.04|||||2-Sided|90.0|0.97|1.11|||||ANCOVA with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold change (CP-690,550-placebo vs. placebo-placebo)|
1663513|NCT01484561|3061403|Superiority or Other||Ratio of Adjusted Geo Mean-Fold Change|0.92|||||2-Sided|90.0|0.86|0.98|||||Analysis of covariance (ANCOVA) with change in logarithmic mGFR from baseline as dependent variable, treatment and logarithmic baseline as covariate.|Ratio of adjusted geometric mean-fold Change (CP-690,550-placebo vs. placebo-placebo)|
1663514|NCT01484496|3061404|Superiority or Other||Odds Ratio (OR)|1.65||||0.0732|2-Sided|95.0|0.95|2.84|||Regression, Logistic||||
1663515|NCT01484496|3061405|Superiority or Other||Hazard Ratio (HR)|0.51||||0.0004|2-Sided|95.0|0.35|0.74|||Cox proportional hazards model||||
1663516|NCT01484496|3061406|Superiority or Other||Odds Ratio (OR)|1.68||||0.0006|2-Sided|95.0|1.25|2.25|||Regression, Logistic||||
1663517|NCT01484132|3061447|Superiority or Other||Slope|-0.083||||0.822|2-Sided|95.0|-0.941|0.775||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.|
1663518|NCT01484132|3061447|Superiority or Other||Slope|-0.018||||0.968|2-Sided|95.0|-1.061|1.025||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.|
1663519|NCT01484132|3061447|Superiority or Other|||||||0.76|||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.|
1663520|NCT01484132|3061448|Superiority or Other||Slope|0.078||||0.696|2-Sided|95.0|-0.339|0.495||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.|
1663535|NCT01484054|3061453|Non-Inferiority or Equivalence|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|4.7|Standard Error of the Mean|2.772|||2-Sided|95.0|-0.79|10.19||||||The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Lens Comfort at 7-9 days of follow-up.|
1663645|NCT01480596|3061726|Superiority or Other||Odds Ratio (OR)|0.4||||0.53|2-Sided|95.0|0.03|2.89|||exact methods||||
1665205|NCT01462435|3064099|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1663521|NCT01484132|3061448|Superiority or Other||Slope|-0.082||||0.612|2-Sided|95.0|-0.418|0.254||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the second treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.|
1663522|NCT01484132|3061448|Superiority or Other|||||||0.41|||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.|
1663523|NCT01484132|3061449|Superiority or Other||Slope|-0.074||||0.501|2-Sided|95.0|-0.293|0.145||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.|
1663524|NCT01484132|3061449|Superiority or Other||Slope|-0.068||||0.48|2-Sided|95.0|-0.258|0.123||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 14 days after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.|
1663525|NCT01484132|3061449|Superiority or Other|||||||0.27|||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.|
1663526|NCT01484132|3061450|Superiority or Other||Slope|0.365||||0.002|2-Sided|95.0|0.145|0.585||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.|
1663527|NCT01484132|3061450|Superiority or Other||Slope|0.299||||0.003|2-Sided|95.0|0.105|0.494||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 1 day after the first treatment, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.|
1663528|NCT01484132|3061450|Superiority or Other|||||||0.11|||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline was different from 0.|
1663529|NCT01484132|3061451|Superiority or Other||Slope|-0.029||||0.574|2-Sided|95.0|-0.131|0.073||P-value is to test the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA after adjusting for covariates.|Mixed Models Analysis|Baseline BPA, season, household income, and canned food were used as covariates.||To see the longitudinal association between composite exposure on posterior occlusal surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.|
1663530|NCT01484132|3061451|Superiority or Other||Slope|-0.123||||0.16|2-Sided|95.0|-0.296|0.05||P-value is to test the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months after adjusting for covariates.|Regression, Linear|Baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on posterior occlusal surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on posterior occlusal surfaces was used as the main predictor.|
1663531|NCT01484132|3061451|Superiority or Other||Slope|-0.017||||0.693|2-Sided|95.0|-0.101|0.067||P-value is to test the longitudinal association between composite exposure on all surfaces and change in BPA after adjusting for covariates.|Mixed Models Analysis|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the longitudinal association between composite exposure on all surfaces and change in BPA from baseline, the repeated measure model was used with all available follow-up BPA data. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.|
1663532|NCT01484132|3061451|Superiority or Other||Slope|-0.061||||0.406|2-Sided|95.0|-0.206|0.084||P-value is to test the association between composite exposure on all surfaces and change in BPA from baseline to 6 months after adjusting for covariates.|Regression, Linear|Composite exposure on all surfaces was used as the main predictor and baseline BPA, season, household income, and canned food were used as covariates.||To see the association between composite exposure on all surfaces and change in BPA from baseline to 6 months, the linear model was used with the change in BPA outcome. Log-transformed BPA was used for the analysis. Composite exposure on all surfaces was used as the main predictor.|
1663533|NCT01484132|3061451|Superiority or Other|||||||0.58|||||||t-test, 2 sided|||One sample t-test was used to test whether the mean change from baseline to 6 months was different from 0.|
1663534|NCT01484054|3061452|Non-Inferiority or Equivalence|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|9.44|Standard Error of the Mean|1.829|||2-Sided|95.0|5.81|13.07||||||Ho: The test lens is non-inferior to the active comparator lens for Handling at 7-9 days follow-up.|
1665206|NCT01462435|3064100|Superiority or Other|||||||0.017|||||||t-test, 2 sided||||
1663536|NCT01484054|3061454|Non-Inferiority or Equivalence|A non-inferiority margin of -5 points(CLUE) was used.|Least square mean difference|1.0|Standard Error of the Mean|2.117|||2-Sided|95.0|-3.2|5.2||||||The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Quality of Lens Vision at 7-9 days of follow-up.|
1663537|NCT01484028|3061462|Non-Inferiority or Equivalence|A non-inferiority margin of 0.05 LogMAR was used.|Least-square mean difference|0.011|Standard Error of the Mean|0.0034|||2-Sided|95.0|0.004|0.017||||||The alternative hypothesis is the monocular distance Snellen VA (LogMAR scale) of etafilcon A with embedded print and PVP for dark/light eyes is non-inferior to that of etafilcon A control lenses.|
1663538|NCT01483937|3061484|Superiority or Other|||||||0.533|||||||ANOVA||||
1663539|NCT01483924|3061485|Superiority or Other|||||||0.6212|||||||Kruskal-Wallis||||
1663540|NCT01483924|3061486|Superiority or Other|||||||0.6349|||||||Kruskal-Wallis||||
1663541|NCT01483924|3061487|Superiority or Other|||||||0.1975|||||||Cochran-Armitage trend test||||
1663542|NCT01483924|3061488|Superiority or Other|||||||0.9048|||||||ANOVA|||The difference in change in PASI score from baseline to Week 12 was compared all active treatment groups and the placebo group|
1663543|NCT01483807|3061501|Superiority|||||||0.212|||||||t-test, 1 sided|||Comparison of effect sizes obtained for untreated SPT-R versus untreated SPT-B items. It was predicted that effect sizes would be greater for SPT-R untreated items.|
1663544|NCT01483807|3061502|Superiority|||||||0.396|||||||t-test, 1 sided|||Comparison of change in accuracy of articulation of untreated items: SPT-R versus SPT-B items. It was predicted that there would be a greater increase in accuracy for SPT-R items.|
1663545|NCT01483807|3061503|Superiority||Mean Difference (Final Values)|8.25||||0.043|1-Sided||||||t-test, 1 sided|||On the basis of existing literature. SPT-R was predicted to be associated with greater increase in articulatory accuracy over baseline levels than SPT-B.|
1663546|NCT01483807|3061504|Superiority||Mean Difference (Final Values)|0.7||||0.254|1-Sided||||||t-test, 1 sided|||Comparison of performance (change in articulation accuracy) with SPT-R versus SPT-B items. Based on the existing literature, it was predicted that the mean effect size associated with SPT-R would be greater than that for SPT-B.|
1663547|NCT01483625|3061506|Superiority or Other||Mean Difference (Final Values)|-4.061|Standard Error of the Mean|3.0115||0.1797|2-Sided|95.0|-10.0157|1.8938|||t-test, 2 sided|95% confidence interval is based on 2 sample t quantiles using pooled variance.||Comparison Tiotropium 18 mcg Vs Placebo Over 12 Weeks|
1663548|NCT01483625|3061509|Superiority or Other||Mean Difference (Final Values)|0.0099|Standard Error of the Mean|0.0806||0.9025|2-Sided|95.0|-0.1489|0.1686||Comparison Tiotropium 18 mcg Vs Placebo at Week 12|Mixed effects repeated measures (MMRM)|Fixed effects:treatment,visit,treatment by visit,baseline and baseline by visit. Patient was random. A spatial power covariance structure was used.|||
1663549|NCT01483625|3061510|Superiority or Other||Geometric mean ratio|0.99|Standard Error of the Mean|0.44||0.7823|2-Sided|95.0|0.9053|1.078|||2sample t quantiles with pooled variance|||Comparison Tiotropium 18 mcg Vs Placebo|
1663550|NCT01483625|3061511|Superiority or Other||Mean Difference (Final Values)|0.0569|Standard Error of the Mean|0.055||0.3025|2-Sided|95.0|-0.0516|0.1654|||Mixed effect repeated measures (MMRM)|Fixed effects:treatment,visit,treatment by visit,baseline and baseline by visit. Random:Patient. A spatial power covariance structure was used.||Tiotropium 18 mcg minus Placebo|
1663551|NCT01483599|3061512|Superiority or Other||||||<|0.001|||||||ANOVA on the van Der Waerden score||||
1663552|NCT01483599|3061512|Superiority or Other||||||<|0.001|||||||ANOVA on the van Der Waerden score||||
1663553|NCT01483599|3061512|Superiority or Other||||||<|0.001|||||||ANOVA on the van Der Waerden score||||
1663554|NCT01483599|3061512|Superiority or Other||||||<|0.001|||||||ANOVA on the van Der Waerden score||||
1663555|NCT01483599|3061512|Superiority or Other||||||<|0.001|||||||ANOVA on the van Der Waerden score||||
1663556|NCT01483599|3061512|Superiority or Other||||||<|0.008|||||||ANOVA on the van Der Waerden score||||
1663557|NCT01483599|3061513|Superiority or Other||Difference in Percentage|32.9|||||2-Sided|95.0|13.0|52.8||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).|
1663558|NCT01483599|3061513|Superiority or Other||Difference in Percentage|28.7|||||2-Sided|95.0|8.5|49.0||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).|
1663559|NCT01483599|3061513|Superiority or Other||Difference in Percentage|22.7|||||2-Sided|95.0|1.8|43.6||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).|
1663560|NCT01483599|3061513|Superiority or Other||Difference in Percentage|10.8|||||2-Sided|95.0|-10.7|32.4||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).|
1663561|NCT01483599|3061513|Superiority or Other||Difference in Percentage|-15.4|||||2-Sided|95.0|-37.7|6.9||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).|
1663562|NCT01483599|3061514|Superiority or Other||Difference in Percentage|25.4|||||2-Sided|95.0|7.2|43.6|||||||
1663563|NCT01483599|3061514|Superiority or Other||Difference in Percentage|27.7|||||2-Sided|95.0|9.8|45.6||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).|
1663564|NCT01483599|3061514|Superiority or Other||Difference in Percentage|20.4|||||2-Sided|95.0|1.5|39.3||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).|
1663646|NCT01480596|3061727|Superiority or Other||Odds Ratio (OR)|1.17||||1|2-Sided|95.0|0.26|5.48|||exact methods||||
1663565|NCT01483599|3061514|Superiority or Other||Difference in Percentage|2.8|||||2-Sided|95.0|-17.9|23.5||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).|
1663566|NCT01483599|3061514|Superiority or Other||Difference in Percentage|-24.0|||||2-Sided|95.0|-44.0|-4.0||||||The difference in percentage was calculated as the percentage of CNTO 1959 participants achieving a PGA score of cleared (0) or minimal (1) minus percentage of adalimumab participants achieving a PGA score of cleared (0) or minimal (1).|
1663567|NCT01483599|3061515|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).|
1663568|NCT01483599|3061515|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).|
1663569|NCT01483599|3061515|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).|
1663570|NCT01483599|3061515|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).|
1663571|NCT01483599|3061515|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).|
1663572|NCT01483599|3061515|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).|
1663573|NCT01483599|3061516|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).|
1663574|NCT01483599|3061516|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).|
1663575|NCT01483599|3061516|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).|
1663576|NCT01483599|3061516|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).|
1663577|NCT01483599|3061516|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (<=90 kg, >90 kg).|
1663578|NCT01483599|3061516|Superiority or Other||||||<|0.002|||||||Cochran-Mantel-Haenszel chi-square test|||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (less than or equal to (<=) 90 kilogram (kg), greater than (>) 90 kg).|
1663579|NCT01482962|3061569|Superiority||Hazard Ratio (HR)|0.95||||0.362|2-Sided|95.0|0.679|1.329|||Stratified Log Rank||Hazard ratio was based on a stratified Cox’s proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.||
1663580|NCT01482962|3061574|Superiority||Hazard Ratio (HR)|0.98||||0.338|2-Sided|95.0|0.707|1.369|||Stratified Log-rank Test||Hazard ratio (HR) was based on a stratified Cox’s proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.||
1663581|NCT01482962|3061575|Superiority||Hazard Ratio (HR)|0.87||||0.177|2-Sided|95.0|0.637|1.178|||Stratified Log Rank||Hazard ratio (HR) was based on a stratified Cox’s proportional hazard regression model with stratification factors: disease type, IPI Score and region with treatment as a factor in the model.||
1663582|NCT01482962|3061576|Superiority||Odds Ratio (OR)|0.6||||0.038|2-Sided|95.0|0.33|1.08||P-value was stratified using disease type, International Prognostic Index (IPI) Score and region as stratification factors.|Cochran-Mantel-Haenszel||||
1663583|NCT01482910|3061577|Superiority or Other||Risk Difference (RD)|6.6||||0.0359|2-Sided|95.0|0.4|12.9||Hierarchical testing procedure was used in the order of pre-defined fixed sequence (primary endpoint first, then confirmatory secondary efficacy point next). A two-sided significance level of 0.05 was used.|Cochran-Mantel-Haenszel|CMH adjusted for baseline BCVA group (<45 letters vs ≥45 letters)|Proportion difference (EYLEA-PDT) was estimated from CMH, where a positive value is in favor of EYLEA.|Null hypothesis: proportions are identical in both groups|
1663584|NCT01482910|3061578|Superiority or Other||Mean Difference (Final Values)|10.1|||<|0.0001|2-Sided|95.0|6.8|13.4||Hierarchical testing procedure was used in the order of pre-defined fixed sequence (primary endpoint first, then confirmatory secondary efficacy point next). A two-sided significance level of 0.05 was used.|ANCOVA|ANCOVA with baseline BCVA as a covariate, and treatment group and baseline BCVA group (<45 letters vs ≥45 letters) as fixed factors|Least square mean difference (EYLEA-PDT) was estimated from ANCOVA, where a positive value is in favor of EYLEA.|Null hypothesis: mean changes are identical in both groups. A sample size of 300 subjects with a 3:1 (EYLEA to PDT) randomization ratio is sufficient to detect the superiority of EYLEA to PDT assuming a two-sided alpha level of 0.05, a power of 90%, a treatment difference of 7.5 letters and a common standard deviation of 14 letters.|
1663585|NCT01482884|3061584|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.33||0.449|2-Sided|95.0|-0.41|0.91|||ANCOVA|Modified Riley score at baseline as a covariate, and treatment as factors in the model.|||
1663586|NCT01482884|3061586|Superiority or Other||Risk Difference (RD)|12.4||||0.0326|2-Sided|95.0|0.7|24.1||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel||||
1663587|NCT01482884|3061587|Superiority or Other||Risk Difference (RD)|12.1||||0.1043|2-Sided|95.0|-4.0|28.3||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel||||
1663588|NCT01482884|3061588|Superiority or Other||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.57||0.3937|2-Sided|95.0|-1.63|0.65|||ANCOVA|Mayo score at baseline as a covariate, and treatment and glucocorticosteroid-refractory status as factors in the model.|||
1664437|NCT01479621|3061901|Superiority or Other||LSM difference|-2.68||||0.6572|2-Sided|95.0|-14.55|9.19||Significance at 0.05|mixed model for repeated measures||||
1663589|NCT01482884|3061589|Superiority or Other||Risk Difference (RD)|4.8||||0.4062|2-Sided|95.0|-13.0|22.5||Glucocorticosteroid-refractory status as stratification factor|Cochran-Mantel-Haenszel|||The null hypothesis is that the proportion of participants responding on tralokinumab is less than or equal to the proportion of participants responding on placebo.|
1663590|NCT01482429|3061603|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1663591|NCT01482429|3061604|Superiority or Other|||||||0.03|||||||binomial test||||
1663592|NCT01482221|3061618|Superiority or Other||LS mean difference|1.4|Standard Error of the Mean|0.9||0.133|2-Sided|95.0|-0.42|3.12||Analysis for changed in QIDS-SR-16 total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663593|NCT01482221|3061618|Superiority or Other||LS mean difference|-0.2|Standard Error of the Mean|0.89||0.788|2-Sided|95.0|-1.98|1.51||Analysis for change in QIDS-SR-16 total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663594|NCT01482221|3061618|Superiority or Other||LS mean difference|0.2|Standard Error of the Mean|0.88||0.842|2-Sided|95.0|-1.56|1.91||Analysis for change in QIDS-SR-16 total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663595|NCT01482221|3061618|Superiority or Other||LS mean difference|-0.6|Standard Error of the Mean|0.87||0.505|2-Sided|95.0|-2.29|1.13||Analysis for change in QIDS-SR-16 total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline QIDS-SR-16 total score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663596|NCT01482221|3061619|Superiority or Other||Odds Ratio (OR)|0.97|Standard Error of the Mean|0.303||0.909|2-Sided|95.0|0.533|1.75|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.|
1663597|NCT01482221|3061619|Superiority or Other||Odds Ratio (OR)|1.38|Standard Error of the Mean|0.292||0.268|2-Sided|95.0|0.78|2.447|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.|
1663598|NCT01482221|3061620|Superiority or Other||Odds Ratio (OR)|1.43|Standard Error of the Mean|0.297||0.23|2-Sided|95.0|0.798|2.558|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.|
1663599|NCT01482221|3061620|Superiority or Other||Odds Ratio (OR)|1.74|Standard Error of the Mean|0.302||0.067|2-Sided|95.0|0.962|3.141|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline CGI-S total score as a covariate.|
1663600|NCT01482221|3061621|Superiority or Other||LS mean difference|0.1|Standard Error of the Mean|0.21||0.54|2-Sided|95.0|-0.29|0.55||Analysis for changed in CGI-S total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663601|NCT01482221|3061621|Superiority or Other||LS mean difference|-0.2|Standard Error of the Mean|0.21||0.283|2-Sided|95.0|-0.64|0.19||Analysis for change in CGI-S total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663602|NCT01482221|3061621|Superiority or Other||LS mean difference|-0.1|Standard Error of the Mean|0.21||0.562|2-Sided|95.0|-0.54|0.29||Analysis for change in CGI-S total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663603|NCT01482221|3061621|Superiority or Other||LS mean difference|-0.1|Standard Error of the Mean|0.21||0.728|2-Sided|95.0|-0.49|0.34||Analysis for change in CGI-S total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline CGI-S score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663604|NCT01482221|3061622|Superiority or Other||LS mean difference|1.29|Standard Error of the Mean|1.329||0.333|2-Sided|95.0|-1.327|3.908||Analysis for changed in SDS total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663642|NCT01480596|3061723|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|1.361||0.986|2-Sided|95.0|-2.76|2.8|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.||
1663605|NCT01482221|3061622|Superiority or Other||LS mean difference|1.11|Standard Error of the Mean|1.301||0.392|2-Sided|95.0|-1.448|3.678||Analysis for change in SDS total score from baseline to Week 12|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663606|NCT01482221|3061622|Superiority or Other||LS mean difference|0.01|Standard Error of the Mean|1.264||0.992|2-Sided|95.0|-2.477|2.501||Analysis for change in SDS total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663607|NCT01482221|3061622|Superiority or Other||LS mean difference|-0.17|Standard Error of the Mean|1.238||0.889|2-Sided|95.0|-2.609|2.264||Analysis for change in SDS total score from baseline to Week 6|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline SDS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline SDS score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663608|NCT01482221|3061623|Superiority or Other||Odds Ratio (OR)|0.78|Standard Error of the Mean|0.368||0.509|2-Sided|95.0|0.382|1.613|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.|
1663609|NCT01482221|3061623|Superiority or Other||Odds Ratio (OR)|1.04|Standard Error of the Mean|0.342||0.911|2-Sided|95.0|0.532|2.031|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.|
1663610|NCT01482221|3061624|Superiority or Other||Odds Ratio (OR)|1.33|Standard Error of the Mean|0.387||0.463|2-Sided|95.0|0.622|2.84|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.|
1663611|NCT01482221|3061624|Superiority or Other||Odds Ratio (OR)|1.42|Standard Error of the Mean|0.382||0.357|2-Sided|95.0|0.672|3.007|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.|
1663612|NCT01482221|3061625|Superiority or Other||Odds Ratio (OR)|0.71|Standard Error of the Mean|0.322||0.286|2-Sided|95.0|0.377|1.334|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.|
1663613|NCT01482221|3061625|Superiority or Other||Odds Ratio (OR)|1.27|Standard Error of the Mean|0.304||0.434|2-Sided|95.0|0.699|2.301|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.|
1663614|NCT01482221|3061626|Superiority or Other||Odds Ratio (OR)|1.2|Standard Error of the Mean|0.315||0.555|2-Sided|95.0|0.65|2.233|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.|
1663615|NCT01482221|3061626|Superiority or Other||Odds Ratio (OR)|0.9|Standard Error of the Mean|0.318||0.751|2-Sided|95.0|0.485|1.686|||GEE for repeated measures|||Generalized linear model of the repeated measures (GEE) with logic link including treatment, visit, and treatment by visit interaction as fixed effects and the baseline MADRS total score as a covariate.|
1663616|NCT01482221|3061627|Superiority or Other||Odds Ratio (OR)|1.08|Standard Error of the Mean|0.37||0.821|2-Sided|95.0|0.552|2.115||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Regression, Logistic|||Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.|
1663617|NCT01482221|3061627|Superiority or Other||Odds Ratio (OR)|1.07|Standard Error of the Mean|0.366||0.852|2-Sided|95.0|0.544|2.089||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Regression, Logistic|||Logistic regression model including treatment as a fixed effect and the baseline MADRS total score as a covariate.|
1663618|NCT01482221|3061628|Superiority or Other||LS mean difference|0.88|Standard Error of the Mean|1.83||0.63|2-Sided|95.0|-2.72|4.485||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663619|NCT01482221|3061628|Superiority or Other||LS mean difference|-2.05|Standard Error of the Mean|1.816||0.63|2-Sided|95.0|-5.628|1.522||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663643|NCT01480596|3061723|Superiority or Other||Mean Difference (Final Values)|-1.01|Standard Error of the Mean|1.245||0.423|2-Sided|95.0|-3.56|1.53|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.||
1663644|NCT01480596|3061725|Superiority or Other||Odds Ratio (OR)|2.7||||0.175|2-Sided|95.0|0.64|11.46|||Cochran-Mantel-Haenszel||||
1663620|NCT01482221|3061629|Superiority or Other||LS mean difference|-1.21|Standard Error of the Mean|1.701||0.476|2-Sided|95.0|-4.563|2.134||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||MMRM includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663621|NCT01482221|3061629|Superiority or Other||LS mean difference|-1.18|Standard Error of the Mean|1.695||0.63|2-Sided|95.0|-4.519|2.152||The adjusted p-values protect the overall family-wise error rate across the 6 key comparisons of AZD6765 100 mg and 50 mg to placebo (for MADRS change from baseline to 6 weeks and to 12 weeks and for Sustained Response).|Mixed models for repeated measures|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, and baseline MADRS score by visit interaction as explanatory variables. Treatment, visit, treatment by visit interaction, and baseline MADRS score by visit interaction are fixed effects in the model; pooled center is a random effect.|
1663622|NCT01482091|3061632|Superiority or Other||||||>|0.05|||||||Fisher Exact||||
1663623|NCT01482091|3061636|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1663624|NCT01482091|3061637|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1663625|NCT01482091|3061638|Superiority or Other||||||=|0|||||||t-test, 2 sided||||
1663626|NCT01482091|3061641|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1663627|NCT01482091|3061642|Superiority or Other||||||=|0|||||||Fisher Exact||||
1663628|NCT01482091|3061644|Superiority or Other|||||||0.048|||||||Wilcoxon (Mann-Whitney)||||
1663629|NCT01481558|3061684|Superiority or Other||Mean Difference (Net)|0.1|Standard Deviation|0.01||0.55|2-Sided|95.0|||||ANCOVA||||
1663630|NCT01481116|3061702|Superiority or Other||Least Squares Mean Difference|-1.44|Standard Error of the Mean|0.678||0.034|2-Sided|95.0|-2.78|-0.11||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Mixed Model Repeated Measures|Treatment, schedule and visit-by-treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates.||Change at Week 78|
1663631|NCT01481116|3061702|Superiority or Other||Least Squares Mean Difference|-1.31|Standard Error of the Mean|0.707||0.065|2-Sided|95.0|-2.7|0.08||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Mixed Model Repeated Measures|Treatment, schedule and visit-by-treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates.||Change at Week 78|
1663632|NCT01481116|3061703|Superiority or Other||Odds Ratio (OR)|0.13|||<|0.001|2-Sided|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 104: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.|
1663633|NCT01481116|3061703|Superiority or Other||Odds Ratio (OR)|0.13|||<|0.001|2-Sided|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 104: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.|
1663634|NCT01481116|3061703|Superiority or Other||Odds Ratio (OR)|0.13|||<|0.001|2-Sided|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 78: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.|
1663635|NCT01481116|3061703|Superiority or Other||Odds Ratio (OR)|0.13|||<|0.001|2-Sided|95.0|0.09|0.18||The testing procedure at 2-sided significance level of 0.025 was as follows: 1) TAK-875 25 mg vs. glimepiride, 2) TAK-875 50 mg plus metformin vs. glimepiride. If P-value was not greater than 0.025 at Step 1, then Step 2 was carried out.|Regression, Logistic|||Day 1 up to Week 78: Odds Ratios, corresponding confidence interval, and p-values were calculated using logistic regression with factors for treatment, country, schedule and baseline HbA1c value.|
1663636|NCT01480596|3061716|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.909||0.775|2-Sided|95.0|-2.12|1.59|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.||
1663637|NCT01480596|3061716|Superiority or Other||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.887||0.756|2-Sided|95.0|-2.1|1.55|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.||
1663638|NCT01480596|3061716|Superiority or Other||Mean Difference (Final Values)|-1.75|Standard Error of the Mean|0.757||0.028|2-Sided|95.0|-3.3|-0.2|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.||
1663639|NCT01480596|3061717|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.844||0.711|2-Sided|95.0|-2.03|1.4|||Mixed Models Analysis||Statistical analysis is presented for Week 24. Standard error of mean is for adjusted mean difference.||
1663640|NCT01480596|3061717|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.707||0.483|2-Sided|95.0|-1.94|0.93|||Mixed Models Analysis||Statistical analysis is presented for Week 12. Standard error of mean is for adjusted mean difference.||
1663641|NCT01480596|3061723|Superiority or Other||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|1.43||0.848|2-Sided|95.0|-3.21|2.65|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.||
1663647|NCT01480596|3061728|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|1.486||0.972|2-Sided|95.0|-2.97|3.07|||Mixed Models Analysis||Standard error of mean is for adjusted difference.||
1663648|NCT01480596|3061729|Superiority or Other||Median Difference (Final Values)|-2.29|Standard Error of the Mean|1.272||0.081|2-Sided|95.0|-4.88|0.3|||Mixed Models Analysis||Analysis for Week 36. Standard error of mean is for adjusted difference.||
1663649|NCT01480596|3061729|Superiority or Other||Median Difference (Final Values)|-1.31|Standard Error of the Mean|1.267||0.31|2-Sided|95.0|-3.89|1.28|||Mixed Models Analysis||Analysis for Week 32. Standard error of mean is for adjusted difference.||
1663650|NCT01480596|3061729|Superiority or Other||Mean Difference (Final Values)|-1.7|Standard Error of the Mean|1.228||0.175|2-Sided|95.0|-4.2|0.8|||Mixed Models Analysis||Analysis for Week 28. Standard error of mean is for adjusted difference.||
1663651|NCT01480596|3061731|Superiority or Other||Odds Ratio (OR)|2.51||||0.184|2-Sided|95.0|0.62|10.1|||Cochran-Mantel-Haenszel||||
1663652|NCT01480596|3061732|Superiority or Other||Odds Ratio (OR)|0.55||||0.827||95.0|0.05|4.35|||exact methods||||
1663653|NCT01480596|3061733|Superiority or Other||Odds Ratio (OR)|3.81||||0.082||95.0|0.87|19.02|||exact methods||||
1663654|NCT01480596|3061734|Superiority or Other||Mean Difference (Final Values)|-1.84|Standard Error of the Mean|1.592||0.256|2-Sided|95.0|-5.08|1.4|||Mixed Models Analysis||Standard error of mean is for adjusted difference.||
1663655|NCT01480284|3061746|Superiority or Other||Mean Difference (Final Values)|-0.01|||||2-Sided|95.0|-0.4|0.39|||||CI and estimate difference is provided for change from Baseline in serum HBV DNA level at Week 48.||
1663656|NCT01480284|3061747|Non-Inferiority or Equivalence|Non-inferiority was judged based on the one-sided test of the model, y(Δ) = Baseline + Group ( Δ= -1.0). The adjusted mean values of the TDF group and the ETV group were calculated, and the adjusted mean value and two-sided 95% confidence interval of differences between the TDF group and the ETV group were calculated. Non-inferiority was also to be confirmed when the upper limit of the calculated two-sided 95% confidence interval was less than the non-inferiority limit value of 1.0|Mean Difference (Final Values)|-0.13|||<|0.0001|2-Sided|95.0|-0.28|0.02||p-value was compared with the significance level of 0.025|ANCOVA||||
1663657|NCT01480258|3061748|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|1.8|||||2-Sided|95.0|-3.2|6.9||||||Vomiting|
1663658|NCT01480258|3061748|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|5.8|||||2-Sided|95.0|1.7|9.8||||||Somnolence|
1663659|NCT01480258|3061748|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|6.4|||||2-Sided|95.0|1.5|11.3||||||Pyrexia|
1663660|NCT01480258|3061748|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|2.2|||||2-Sided|95.0|-1.0|5.4||||||Irritability|
1663661|NCT01480258|3061748|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|3.6|||||2-Sided|95.0|-1.6|8.8||||||Decreased appetite|
1663662|NCT01480258|3061748|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|2.2|||||2-Sided|95.0|-1.3|5.7||||||Crying|
1663663|NCT01480258|3061749|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|1.1||||||95.0|-0.4|2.7||||||Injection-site warmth|
1663664|NCT01480258|3061749|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.3|||||2-Sided|95.0|-0.8|1.5||||||Injection-site nodule|
1663665|NCT01480258|3061749|Other||Risk Difference (RD)|2.6|||||2-Sided|95.0|-1.2|6.4||||||Injection-site induration|
1663666|NCT01480258|3061749|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.0|||||2-Sided|95.0|-1.5|1.6||||||Injection-site haemorrhage|
1663667|NCT01480258|3061749|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|-1.1|||||2-Sided|95.0|-2.5|0.3||||||Injection-site bruising|
1664438|NCT01479621|3061901|Superiority or Other||LSM difference|-4.48||||0.4709|2-Sided|95.0|-16.69|7.721||Significance at 0.05|mixed model for repeated measures||||
1663668|NCT01480258|3061750|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|7.5||||||95.0|2.1|12.9||||||Injection-site swelling|
1663669|NCT01480258|3061750|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|3.4|||||2-Sided|95.0|-1.5|8.3||||||Injection-site pain|
1663670|NCT01480258|3061750|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk Difference (RD)|8.2|||||2-Sided|95.0|3.0|13.3||||||Injection-site erythema|
1663671|NCT01480258|3061751|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.9||||||95.0|-0.4|2.3||||||At least 1 vaccine-related solicited systemic AE|
1663672|NCT01480258|3061751|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8|||||2-Sided|95.0|-0.5|2.2||||||At least 1 solicited systemic AE|
1663673|NCT01480258|3061751|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8|||||2-Sided|95.0|-0.5|2.2||||||At least 1 vaccine-related systemic AE|
1663674|NCT01480258|3061751|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.1|||||2-Sided|95.0|-1.1|1.4||||||At least 1 systemic AE|
1663675|NCT01480258|3061751|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|2.5|||||2-Sided|95.0|-0.9|5.9||||||At least 1 solicited ISR|
1663676|NCT01480258|3061751|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|2.6|||||2-Sided|95.0|-0.7|6.0||||||At least 1 ISR|
1663677|NCT01480258|3061751|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.8||||||95.0|-0.3|2.0||||||ISR or V-related systemic AE|
1663678|NCT01480258|3061751|Other|The risk differences between groups (PR5I group – INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen & Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.|Risk Difference (RD)|0.3|||||2-Sided|95.0|-0.7|1.4||||||ISR or systemic AE|
1663679|NCT01480258|3061752|Non-Inferiority|The estimate for anti-rotavirus IgA GMT ratio (PR5I group/INFANRIX hexa group) was calculated with its 1-sided P-value and 2-sided 95% CI. If the lower bound of the 95% CI for GMT ratio was greater than 0.50 (non-inferiority margin), it was concluded that the Rotarix antigen response in the PR5I group was not inferior to the Rotarix antigen response in the INFANRIX hexa group.|Geometric Mean Titre (GMT) ratio|0.8||||0.011|2-Sided|95.0|0.54|1.2|||ANCOVA||||
1663680|NCT01480258|3061753|Non-Inferiority|The estimate of the difference between PR5I & INFANRIX hexa groups in IPV3 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value & 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.16|||<|0.001|2-Sided|95.0|-1.2|0.82|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen & Nurminen method stratified by country.||Non-Inferiority for IPV3|
1663681|NCT01480258|3061753|Non-Inferiority|The estimate of the difference between PR5I & INFANRIX hexa groups in IPV2 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value & 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.17|||<|0.001|2-Sided|95.0|-0.96|0.49|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen & Nurminen method stratified by country.||Non-Inferiority for IPV2|
1663698|NCT01480258|3061756|Other|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PT seroresponse|
1664439|NCT01479621|3061901|Superiority or Other||LSM difference|-15.26||||0.0158|2-Sided|95.0|-27.63|-2.88||Significance at 0.05|mixed model for repeated measures||||
1663682|NCT01480258|3061753|Non-Inferiority|The estimate of the difference between PR5I & INFANRIX hexa groups in IPV1 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value & 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.51|||<|0.001|2-Sided|95.0|-1.59|0.34|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen & Nurminen method stratified by country.||Non-Inferiority for IPV1|
1663683|NCT01480258|3061753|Non-Inferiority|The estimate of the difference between PR5I & INFANRIX hexa groups in the percentage of seroresponder participants for PRN was calculated with its 1-sided P-value & 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.42|||<|0.001|2-Sided|95.0|-3.42|0.39|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen & Nurminen method stratified by country.||Non-Inferiority for PRN|
1663684|NCT01480258|3061753|Non-Inferiority|The estimate of the difference between PR5I & INFANRIX hexa groups in the percentage of seroresponder participants for FHA was calculated with its 1-sided P-value & 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.73|||<|0.001|2-Sided|95.0|-3.47|-0.26|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen & Nurminen method stratified by country.||Non-Inferiority for FHA|
1663685|NCT01480258|3061753|Non-Inferiority|The estimate of the difference between PR5I & INFANRIX hexa groups in the percentage of seroresponder participants for PT was calculated with its 1-sided P-value & 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.54|||<|0.001|2-Sided|95.0|-1.75|0.49|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen & Nurminen method stratified by country.||Non-Inferiority for PT|
1663686|NCT01480258|3061753|Non-Inferiority|The estimate of the difference between PR5I & INFANRIX hexa groups in Tetanus response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value & 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.17|||<|0.001|2-Sided|95.0|-0.95|0.5|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen & Nurminen method stratified by country.||Non-Inferiority for Tetanus|
1663687|NCT01480258|3061753|Non-Inferiority|The estimate of the difference between PR5I & INFANRIX hexa groups in Diphtheria response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value & 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.21|||<|0.001|2-Sided|95.0|-2.54|-0.22|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen & Nurminen method stratified by country.||Non-Inferiority for Diptheria|
1663688|NCT01480258|3061753|Non-Inferiority|The estimate of the difference between PR5I & INFANRIX hexa groups in HBsAg response rate (based on Ab titre ≥10 mIU/mL) was calculated with its 1-sided P-value & 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|ifference in percentages|-0.59|||<|0.001|2-Sided|95.0|-2.66|1.35|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen & Nurminen method stratified by country.||Non-Inferiority for HBsAg|
1663689|NCT01480258|3061753|Non-Inferiority|The estimate of the difference between PR5I & INFANRIX hexa groups in PRP response rate (based on Ab titre ≥1.0 μg/mL) was calculated with its 1-sided P-value & 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-1.27|||<|0.001|2-Sided|95.0|-5.13|2.52|||Miettinen & Nurminen with stratification|Statistical analysis was based on the Miettinen & Nurminen method stratified by country.||Non-inferiority for PRP|
1663690|NCT01480258|3061754|Superiority|If the lower bound of the 95% CI was greater than 0, it was concluded that PR5I group response rate was superior to INFANRIX hexa group response rate.|Difference in percentages|46.2|||<|0.001|2-Sided|95.0|41.05|51.06|||Miettinen & Nurminen|Stratification by country.|||
1663691|NCT01480258|3061755|Non-Inferiority|If the lower bound of the 95% confidence interval (CI) was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|46.2|||<|0.001|2-Sided|95.0|41.05|51.06||Stratification by country.|Miettinen & Nurminen||||
1663692|NCT01480258|3061756|Other|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV3 ≥1:8 dilution|
1663693|NCT01480258|3061756|Other|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV2 ≥1:8 dilution|
1663694|NCT01480258|3061756|Other|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-IPV1 ≥1:8 dilution|
1663695|NCT01480258|3061756|Other|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PRN seroresponse|
1663696|NCT01480258|3061756|Other|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-FIM seroresponse|
1663697|NCT01480258|3061756|Other|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-FHA seroresponse|
1664769|NCT01474122|3062615|Superiority or Other||Mean Difference (Net)|-0.1||||0.347|2-Sided|95.0|-0.2|0.1|||ANCOVA||||
1663699|NCT01480258|3061756|Other|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-Tetanus ≥0.1 IU/mL|
1663700|NCT01480258|3061756|Other|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-Diphtheria ≥0.1 IU/mL|
1663701|NCT01480258|3061756|Other|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-HBsAg ≥10 mIU/mL|
1663702|NCT01480258|3061756|Other|The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.|||||<|0.001||||||One-sided p-value|Clopper and Pearson|||Anti-PRP ≥ 1.0 μg/mL|
1663703|NCT01480219|3061762|Superiority or Other||Hazard Ratio (HR)|1.23||||0.453|2-Sided|95.0|0.71|2.14|||Regression, Cox|||HR and corresponding 95% CI were calculated using a parsimoniously adjusted Cox proportional hazards regression model.|
1663704|NCT01480219|3061762|Superiority or Other||Hazard Ratio (HR)|1.74||||0.042|2-Sided|95.0|1.02|2.96|||Regression, Cox|||Crude hazard ratio (HR) and corresponding 95 percent (%) confidence interval (CI) were calculated using an unadjusted Cox proportional hazards regression model.|
1663705|NCT01480180|3061832|Other||Poisson estimate|4.39|||<|0.001|2-Sided|95.0|3.09|6.24||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.|
1663706|NCT01480180|3061832|Other||Poisson estimate|2.35|||<|0.001|2-Sided|95.0|1.87|2.95||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.|
1663707|NCT01480180|3061834|Other||Poisson estimate|3.27|||<|0.001|2-Sided|95.0|2.59|4.11||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.|
1663708|NCT01480180|3061836|Other||Poisson estimate|3.7|||<|0.001|2-Sided|95.0|2.94|4.66||P-values are from the 1-sided test of the null hypothesis that the ABR is at least 8.5 evaluated at the 2.5% level.|Poisson regression|||The analysis is based on a Poisson regression model allowing for over-dispersion. For participants withdrawing prematurely, the log planned treatment duration is used as offset; for completers, the log actual treatment duration is used.|
1663709|NCT01480089|3061838|Superiority or Other||Mean Difference (Final Values)|-0.065|Standard Error of the Mean|0.53||0.9|2-Sided|95.0|-1.103|0.973|||t-test, 2 sided|||The null hypothesis is that the mean VAS score 12 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).|
1663710|NCT01480089|3061839|Superiority or Other||Mean Difference (Final Values)|-1.308|Standard Error of the Mean|0.777||0.098|2-Sided|95.0|-2.83|0.214|||t-test, 2 sided|||The null hypothesis is that the mean VAS score 2 hours post surgery is equivalent for individuals randomized to Intraperitoneal Ropivacaine(AIR) and those randomized to Atomized Intraperitoneal Saline (AIS).|
1663711|NCT01480076|3061841|Superiority or Other||difference of LS means|0.7|Standard Error of the Mean|5.95||0.9078|2-Sided||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663712|NCT01480076|3061841|Superiority or Other||difference of LS means|-7.2|Standard Error of the Mean|3.67||0.0498|2-Sided||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663713|NCT01480076|3061841|Superiority or Other|||||||0.0427|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663714|NCT01480076|3061841|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663715|NCT01480076|3061841|Superiority or Other||||||<|0.7241|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664235|NCT01480076|3061861|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1663716|NCT01480076|3061841|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663717|NCT01480076|3061841|Superiority or Other||difference of LS means|-13.6|Standard Error of the Mean|6.07|<|0.0255|2-Sided||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663718|NCT01480076|3061841|Superiority or Other||difference of LS means|-3.9|Standard Error of the Mean|3.47|<|0.2561|2-Sided||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663719|NCT01480076|3061841|Superiority or Other||||||<|0.7814|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663720|NCT01480076|3061841|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663721|NCT01480076|3061841|Superiority or Other||||||<|0.0937|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663722|NCT01480076|3061841|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663723|NCT01480076|3061841|Superiority or Other||difference of LS means|-14.1|Standard Error of the Mean|5.42|<|0.0093|2-Sided||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663724|NCT01480076|3061841|Superiority or Other||difference of LS means|-5.2|Standard Error of the Mean|3.37|<|0.1249|2-Sided||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663725|NCT01480076|3061841|Superiority or Other||||||<|0.9232|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663726|NCT01480076|3061841|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663727|NCT01480076|3061841|Superiority or Other||||||<|0.0628|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663728|NCT01480076|3061841|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663755|NCT01480076|3061842|Superiority or Other|||||||0.6067|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663729|NCT01480076|3061841|Superiority or Other||difference of LS means|-13.9|Standard Error of the Mean|5.37|<|0.0097|2-Sided||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663730|NCT01480076|3061841|Superiority or Other||difference of LS means|-9.3|Standard Error of the Mean|3.2|<|0.0038|2-Sided||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663731|NCT01480076|3061841|Superiority or Other||||||<|0.723|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663732|NCT01480076|3061841|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663733|NCT01480076|3061841|Superiority or Other||||||<|0.2894|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663734|NCT01480076|3061841|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663735|NCT01480076|3061841|Superiority or Other||difference of LS means|-10.2|Standard Error of the Mean|4.23|<|0.0158|2-Sided||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663736|NCT01480076|3061841|Superiority or Other||difference of LS means|-6.4|Standard Error of the Mean|2.56|<|0.0125|2-Sided||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663737|NCT01480076|3061841|Superiority or Other||||||<|0.4578|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663738|NCT01480076|3061841|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663739|NCT01480076|3061841|Superiority or Other||||||<|0.1152|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663740|NCT01480076|3061841|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the regular activity productivity loss, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663741|NCT01480076|3061842|Superiority or Other||difference of LS means|2.1|Standard Error of the Mean|15.54||0.8917|2-Sided||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664113|NCT01480076|3061855|Superiority or Other|||||||0.898|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1663742|NCT01480076|3061842|Superiority or Other||difference of LS means|10.8|Standard Error of the Mean|8.07||0.1831|2-Sided||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663743|NCT01480076|3061842|Superiority or Other|||||||0.5746|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663744|NCT01480076|3061842|Superiority or Other|||||||0.1086|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663745|NCT01480076|3061842|Superiority or Other|||||||0.1138|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663746|NCT01480076|3061842|Superiority or Other|||||||0.5129|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663747|NCT01480076|3061842|Superiority or Other||difference of LS means|-9.2|Standard Error of the Mean|26.07||0.7249|2-Sided||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663748|NCT01480076|3061842|Superiority or Other||difference of LS means|16.9|Standard Error of the Mean|10.88||0.1226|2-Sided||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663749|NCT01480076|3061842|Superiority or Other|||||||0.8854|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663750|NCT01480076|3061842|Superiority or Other|||||||0.2884|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663751|NCT01480076|3061842|Superiority or Other|||||||0.086|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663752|NCT01480076|3061842|Superiority or Other|||||||0.6261|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663753|NCT01480076|3061842|Superiority or Other||difference of LS means|0.5|Standard Error of the Mean|16.09||0.9761|2-Sided||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663754|NCT01480076|3061842|Superiority or Other||difference of LS means|-6.0|Standard Error of the Mean|7.56||0.4309|2-Sided||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664114|NCT01480076|3061855|Superiority or Other|||||||0.3849|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1663756|NCT01480076|3061842|Superiority or Other|||||||0.047|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663757|NCT01480076|3061842|Superiority or Other|||||||0.8105|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663758|NCT01480076|3061842|Superiority or Other|||||||0.0056|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663759|NCT01480076|3061842|Superiority or Other||difference of LS means|-25.1|Standard Error of the Mean|21.35||0.2405|2-Sided||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663760|NCT01480076|3061842|Superiority or Other||difference of LS means|-1.3|Standard Error of the Mean|7.11||0.8548|2-Sided||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663761|NCT01480076|3061842|Superiority or Other|||||||0.3965|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663762|NCT01480076|3061842|Superiority or Other|||||||0.0654|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663763|NCT01480076|3061842|Superiority or Other|||||||0.3467|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663764|NCT01480076|3061842|Superiority or Other|||||||0.0059|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663765|NCT01480076|3061842|Superiority or Other||difference of LS means|-7.9|Standard Error of the Mean|14.64||0.5885|2-Sided||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663766|NCT01480076|3061842|Superiority or Other||difference of LS means|5.1|Standard Error of the Mean|6.28||0.4177|2-Sided||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663767|NCT01480076|3061842|Superiority or Other|||||||0.9327|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663768|NCT01480076|3061842|Superiority or Other|||||||0.0451|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663769|NCT01480076|3061842|Superiority or Other|||||||0.1166|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663770|NCT01480076|3061842|Superiority or Other|||||||0.0628|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % overall work impairment due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663771|NCT01480076|3061843|Superiority or Other||difference of LS means|16.8|Standard Error of the Mean|15.53||0.2794|2-Sided||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663772|NCT01480076|3061843|Superiority or Other||difference of LS means|6.6|Standard Error of the Mean|7.65||0.3903|2-Sided||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663773|NCT01480076|3061843|Superiority or Other|||||||0.1778|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663774|NCT01480076|3061843|Superiority or Other|||||||0.2965|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663775|NCT01480076|3061843|Superiority or Other|||||||0.4674|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663776|NCT01480076|3061843|Superiority or Other|||||||0.6627|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663777|NCT01480076|3061843|Superiority or Other||difference of LS means|0.4|Standard Error of the Mean|19.12||0.9826|2-Sided||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663778|NCT01480076|3061843|Superiority or Other||difference of LS means|17.1|Standard Error of the Mean|7.38||0.0214|2-Sided||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663779|NCT01480076|3061843|Superiority or Other|||||||0.7523|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663780|NCT01480076|3061843|Superiority or Other|||||||0.1185|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663781|NCT01480076|3061843|Superiority or Other|||||||0.0102|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663782|NCT01480076|3061843|Superiority or Other|||||||0.4486|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663809|NCT01480076|3061844|Superiority or Other|||||||0.528|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663783|NCT01480076|3061843|Superiority or Other||difference of LS means|7.9|Standard Error of the Mean|13.42||0.5575|2-Sided||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663784|NCT01480076|3061843|Superiority or Other||difference of LS means|-1.8|Standard Error of the Mean|5.89||0.7578|2-Sided||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663785|NCT01480076|3061843|Superiority or Other|||||||0.2312|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663786|NCT01480076|3061843|Superiority or Other|||||||0.0091|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663787|NCT01480076|3061843|Superiority or Other|||||||0.5207|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663788|NCT01480076|3061843|Superiority or Other|||||||0.0139|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663789|NCT01480076|3061843|Superiority or Other||difference of LS means|-4.8|Standard Error of the Mean|14.25||0.7385|2-Sided||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663790|NCT01480076|3061843|Superiority or Other||difference of LS means|-5.1|Standard Error of the Mean|6.06||0.4035|2-Sided||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663791|NCT01480076|3061843|Superiority or Other|||||||0.8147|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663792|NCT01480076|3061843|Superiority or Other|||||||0.0134|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663793|NCT01480076|3061843|Superiority or Other|||||||0.8634|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663794|NCT01480076|3061843|Superiority or Other|||||||0.01|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663795|NCT01480076|3061843|Superiority or Other||difference of LS means|5.1|Standard Error of the Mean|10.95||0.642|2-Sided||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664440|NCT01479621|3061902|Superiority or Other||LSM difference|4.24||||0.5072|2-Sided|95.0|-8.31|16.78||Significance at 0.05|mixed model for repeated measures||||
1664441|NCT01479621|3061902|Superiority or Other||LSM difference|-5.69||||0.3691|2-Sided|95.0|-18.12|6.74||Significance at 0.05|mixed model for repeated measures||||
1663796|NCT01480076|3061843|Superiority or Other||difference of LS means|4.2|Standard Error of the Mean|4.95||0.3968|2-Sided||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663797|NCT01480076|3061843|Superiority or Other|||||||0.292|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663798|NCT01480076|3061843|Superiority or Other|||||||0.0187|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663799|NCT01480076|3061843|Superiority or Other|||||||0.1448|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663800|NCT01480076|3061843|Superiority or Other|||||||0.1392|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % impairment while working due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663801|NCT01480076|3061844|Superiority or Other||difference of LS means|-11.7|Standard Error of the Mean|15.88||0.4635|2-Sided||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663802|NCT01480076|3061844|Superiority or Other||difference of LS means|15.2|Standard Error of the Mean|7.31||0.0387|2-Sided||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663803|NCT01480076|3061844|Superiority or Other|||||||0.4989|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663804|NCT01480076|3061844|Superiority or Other|||||||0.7707|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663805|NCT01480076|3061844|Superiority or Other|||||||0.0245|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663806|NCT01480076|3061844|Superiority or Other|||||||0.6901|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663807|NCT01480076|3061844|Superiority or Other||difference of LS means|-16.0|Standard Error of the Mean|22.24||0.4743|2-Sided||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663808|NCT01480076|3061844|Superiority or Other||difference of LS means|11.5|Standard Error of the Mean|8.51||0.1769|2-Sided||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663920|NCT01480076|3061847|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663810|NCT01480076|3061844|Superiority or Other|||||||0.6161|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663811|NCT01480076|3061844|Superiority or Other|||||||0.1265|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663812|NCT01480076|3061844|Superiority or Other|||||||0.6352|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663813|NCT01480076|3061844|Superiority or Other||difference of LS means|-10.7|Standard Error of the Mean|12.27||0.3863|2-Sided||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663814|NCT01480076|3061844|Superiority or Other||difference of LS means|4.3|Standard Error of the Mean|5.58||0.4444|2-Sided||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663815|NCT01480076|3061844|Superiority or Other|||||||0.5979|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663816|NCT01480076|3061844|Superiority or Other|||||||0.1552|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663817|NCT01480076|3061844|Superiority or Other|||||||0.064|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663818|NCT01480076|3061844|Superiority or Other|||||||0.0071|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663819|NCT01480076|3061844|Superiority or Other||difference of LS means|-30.6|Standard Error of the Mean|17.91||0.0887|2-Sided||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663820|NCT01480076|3061844|Superiority or Other||difference of LS means|4.6|Standard Error of the Mean|6.27||0.4644|2-Sided||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663821|NCT01480076|3061844|Superiority or Other|||||||0.108|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663822|NCT01480076|3061844|Superiority or Other|||||||0.5528|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663823|NCT01480076|3061844|Superiority or Other|||||||0.1764|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663824|NCT01480076|3061844|Superiority or Other|||||||0.1251|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663825|NCT01480076|3061844|Superiority or Other||difference of LS means|-17.2|Standard Error of the Mean|12.22||0.1601|2-Sided||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663826|NCT01480076|3061844|Superiority or Other||difference of LS means|8.9|Standard Error of the Mean|4.96||0.0743|2-Sided||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663827|NCT01480076|3061844|Superiority or Other|||||||0.2214|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663828|NCT01480076|3061844|Superiority or Other|||||||0.3868|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663829|NCT01480076|3061844|Superiority or Other|||||||0.0167|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663830|NCT01480076|3061844|Superiority or Other|||||||0.1544|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the % work time missed due to MS, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663831|NCT01480076|3061845|Superiority or Other||least squares mean|0.03|Standard Error of the Mean|0.05||0.5663|2-Sided||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663832|NCT01480076|3061845|Superiority or Other||difference of LS means|0.06|Standard Error of the Mean|0.03||0.0748|2-Sided||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663833|NCT01480076|3061845|Superiority or Other|||||||0.3827|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663834|NCT01480076|3061845|Superiority or Other|||||||0.0002|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663835|NCT01480076|3061845|Superiority or Other|||||||0.428|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663836|NCT01480076|3061845|Superiority or Other|||||||0.0141|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663863|NCT01480076|3061846|Superiority or Other||||||<|0.7329|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663837|NCT01480076|3061845|Superiority or Other||difference of LS means|0.03|Standard Error of the Mean|0.05||0.5089|2-Sided||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663838|NCT01480076|3061845|Superiority or Other||difference of LS means|0.03|Standard Error of the Mean|0.03||0.3358|2-Sided||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663839|NCT01480076|3061845|Superiority or Other|||||||0.6368|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663840|NCT01480076|3061845|Superiority or Other|||||||0.0027|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663841|NCT01480076|3061845|Superiority or Other|||||||0.9926|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663842|NCT01480076|3061845|Superiority or Other|||||||0.0245|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663843|NCT01480076|3061845|Superiority or Other||difference of LS means|0.02|Standard Error of the Mean|0.05||0.587|2-Sided||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663844|NCT01480076|3061845|Superiority or Other||difference of LS means|0.05|Standard Error of the Mean|0.03||0.0699|2-Sided||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663845|NCT01480076|3061845|Superiority or Other|||||||0.5475|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663846|NCT01480076|3061845|Superiority or Other|||||||0.0056|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663847|NCT01480076|3061845|Superiority or Other|||||||0.9371|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663848|NCT01480076|3061845|Superiority or Other|||||||0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663849|NCT01480076|3061845|Superiority or Other||difference of LS means|0.09|Standard Error of the Mean|0.04||0.0175|2-Sided||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664442|NCT01479621|3061902|Superiority or Other||LSM difference|2.67||||0.6689|2-Sided|95.0|-9.58|14.92||Significance at 0.05|mixed model for repeated measures||||
1664443|NCT01479621|3061902|Superiority or Other||LSM difference|0.69||||0.9135|2-Sided|95.0|-11.84|13.23||Significance at 0.05|mixed model for repeated measures||||
1663850|NCT01480076|3061845|Superiority or Other||difference of LS means|0.05|Standard Error of the Mean|0.02||0.0516|2-Sided||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663851|NCT01480076|3061845|Superiority or Other|||||||0.5454|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663852|NCT01480076|3061845|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663853|NCT01480076|3061845|Superiority or Other||||||<|0.4481|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663854|NCT01480076|3061845|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663855|NCT01480076|3061845|Superiority or Other||difference of LS means|0.05|Standard Error of the Mean|0.04|<|0.1919|2-Sided||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663856|NCT01480076|3061845|Superiority or Other||difference of LS means|0.05|Standard Error of the Mean|0.02|<|0.0331|2-Sided||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663857|NCT01480076|3061845|Superiority or Other||||||<|0.6128|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663858|NCT01480076|3061845|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663859|NCT01480076|3061845|Superiority or Other||||||<|0.9151|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663860|NCT01480076|3061845|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D index scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663861|NCT01480076|3061846|Superiority or Other||difference of LS means|10.1|Standard Error of the Mean|4.49||0.0242|2-Sided||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663862|NCT01480076|3061846|Superiority or Other||difference of LS means|13.2|Standard Error of the Mean|2.65|<|0.0001|2-Sided||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664444|NCT01479621|3061902|Superiority or Other||LSM difference|-17.66||||0.0068|2-Sided|95.0|-30.43|-4.89||Significance at 0.05|mixed model for repeated measures||||
1664445|NCT01479621|3061903|Superiority or Other||LSM difference|-0.062||||0.1306|2-Sided|95.0|-0.143|0.018||Significance at 0.05|mixed model for repeated measures||||
1663864|NCT01480076|3061846|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663865|NCT01480076|3061846|Superiority or Other||||||<|0.0042|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663866|NCT01480076|3061846|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663867|NCT01480076|3061846|Superiority or Other||difference of LS means|10.5|Standard Error of the Mean|4.28|<|0.0141|2-Sided||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663868|NCT01480076|3061846|Superiority or Other||difference of LS means|11.6|Standard Error of the Mean|2.49|<|0.0001|2-Sided||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663869|NCT01480076|3061846|Superiority or Other||||||<|0.6684|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663870|NCT01480076|3061846|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663871|NCT01480076|3061846|Superiority or Other||||||<|0.0158|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663872|NCT01480076|3061846|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663873|NCT01480076|3061846|Superiority or Other||difference of LS means|7.1|Standard Error of the Mean|3.85|<|0.0666|2-Sided||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663874|NCT01480076|3061846|Superiority or Other||difference of LS means|10.8|Standard Error of the Mean|2.31|<|0.0001|2-Sided||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663875|NCT01480076|3061846|Superiority or Other||||||<|0.6911|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663876|NCT01480076|3061846|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663877|NCT01480076|3061846|Superiority or Other||||||<|0.0179|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663878|NCT01480076|3061846|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663879|NCT01480076|3061846|Superiority or Other||difference of LS means|9.8|Standard Error of the Mean|3.57|<|0.0061|2-Sided||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663880|NCT01480076|3061846|Superiority or Other||difference of LS means|11.6|Standard Error of the Mean|2.1|<|0.0001|2-Sided||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663881|NCT01480076|3061846|Superiority or Other||||||<|0.7182|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663882|NCT01480076|3061846|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663883|NCT01480076|3061846|Superiority or Other||||||<|0.0689|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663884|NCT01480076|3061846|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663885|NCT01480076|3061846|Superiority or Other||difference of LS means|9.4|Standard Error of the Mean|3.1|<|0.0026|2-Sided||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663886|NCT01480076|3061846|Superiority or Other||difference of LS means|11.8|Standard Error of the Mean|1.85|<|0.0001|2-Sided||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663887|NCT01480076|3061846|Superiority or Other||||||<|0.8041|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663888|NCT01480076|3061846|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663889|NCT01480076|3061846|Superiority or Other||||||<|0.0029|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663890|NCT01480076|3061846|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the current health state of EQ-5D scores, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663905|NCT01480076|3061847|Superiority or Other||||||<|0.3313|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663891|NCT01480076|3061847|Superiority or Other||difference of LS means|-1.9|Standard Error of the Mean|1.86||0.2971|2-Sided||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663892|NCT01480076|3061847|Superiority or Other||difference of LS means|-1.8|Standard Error of the Mean|0.94||0.0561|2-Sided||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663893|NCT01480076|3061847|Superiority or Other|||||||0.5832|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663894|NCT01480076|3061847|Superiority or Other|||||||0.057|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663895|NCT01480076|3061847|Superiority or Other|||||||0.2272|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663896|NCT01480076|3061847|Superiority or Other|||||||0.0168|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663897|NCT01480076|3061847|Superiority or Other||difference of LS means|-2.7|Standard Error of the Mean|1.72||0.1224|2-Sided||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663898|NCT01480076|3061847|Superiority or Other||difference of LS means|-3.0|Standard Error of the Mean|0.84||0.0003|2-Sided||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663899|NCT01480076|3061847|Superiority or Other|||||||0.5146|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663900|NCT01480076|3061847|Superiority or Other|||||||0.0007|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663901|NCT01480076|3061847|Superiority or Other|||||||0.0171|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663902|NCT01480076|3061847|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663903|NCT01480076|3061847|Superiority or Other||difference of LS means|-3.4|Standard Error of the Mean|1.39|<|0.015|2-Sided||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663904|NCT01480076|3061847|Superiority or Other||difference of LS means|-1.9|Standard Error of the Mean|0.83|<|0.0238|2-Sided||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663906|NCT01480076|3061847|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663907|NCT01480076|3061847|Superiority or Other||||||<|0.4256|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663908|NCT01480076|3061847|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663909|NCT01480076|3061847|Superiority or Other||difference of LS means|-2.9|Standard Error of the Mean|1.18|<|0.0161|2-Sided||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663910|NCT01480076|3061847|Superiority or Other||difference of LS means|-1.6|Standard Error of the Mean|0.68|<|0.0207|2-Sided||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663911|NCT01480076|3061847|Superiority or Other||||||<|0.9989|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663912|NCT01480076|3061847|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663913|NCT01480076|3061847|Superiority or Other||||||<|0.4243|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663914|NCT01480076|3061847|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663915|NCT01480076|3061847|Superiority or Other||difference of LS means|-2.7|Standard Error of the Mean|1.15|<|0.0188|2-Sided||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663916|NCT01480076|3061847|Superiority or Other||difference of LS means|-2.1|Standard Error of the Mean|0.64|<|0.0013|2-Sided||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663917|NCT01480076|3061847|Superiority or Other||||||<|0.4487|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663918|NCT01480076|3061847|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663919|NCT01480076|3061847|Superiority or Other||||||<|0.2087|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline of the total ALS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664446|NCT01479621|3061903|Superiority or Other||LSM difference|-0.002||||0.9586|2-Sided|95.0|-0.082|0.078||Significance at 0.05|mixed model for repeated measures||||
1665207|NCT01462435|3064100|Superiority or Other|||||||0.026|||||||t-test, 2 sided||||
1663921|NCT01480076|3061848|Superiority or Other||difference of LS means|-4.1|Standard Error of the Mean|4.32||0.3457|2-Sided||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663922|NCT01480076|3061848|Superiority or Other||difference of LS means|-7.5|Standard Error of the Mean|2.67||0.0049|2-Sided||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663923|NCT01480076|3061848|Superiority or Other|||||||0.2239|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663924|NCT01480076|3061848|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663925|NCT01480076|3061848|Superiority or Other||||||<|0.6279|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663926|NCT01480076|3061848|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663927|NCT01480076|3061848|Superiority or Other||difference of LS means|-6.4|Standard Error of the Mean|4.37|<|0.1414|2-Sided||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663928|NCT01480076|3061848|Superiority or Other||difference of LS means|-5.9|Standard Error of the Mean|2.54|<|0.0204|2-Sided||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663929|NCT01480076|3061848|Superiority or Other||||||<|0.5655|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663930|NCT01480076|3061848|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663931|NCT01480076|3061848|Superiority or Other||||||<|0.9398|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663932|NCT01480076|3061848|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663933|NCT01480076|3061848|Superiority or Other||difference of LS means|-6.9|Standard Error of the Mean|3.73|<|0.0632|2-Sided||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664233|NCT01480076|3061861|Superiority or Other||||||<|0.0935|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1663934|NCT01480076|3061848|Superiority or Other||difference of LS means|-4.5|Standard Error of the Mean|2.32|<|0.0553|2-Sided||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663935|NCT01480076|3061848|Superiority or Other||||||<|0.4767|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663936|NCT01480076|3061848|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663937|NCT01480076|3061848|Superiority or Other||||||<|0.272|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663938|NCT01480076|3061848|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663939|NCT01480076|3061848|Superiority or Other||difference of LS means|-10.1|Standard Error of the Mean|3.5|<|0.0038|2-Sided||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663940|NCT01480076|3061848|Superiority or Other||difference of LS means|-9.2|Standard Error of the Mean|2.11|<|0.0001|2-Sided||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663941|NCT01480076|3061848|Superiority or Other||||||<|0.7718|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663942|NCT01480076|3061848|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663943|NCT01480076|3061848|Superiority or Other||||||<|0.9091|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663944|NCT01480076|3061848|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663945|NCT01480076|3061848|Superiority or Other||difference of LS means|-6.9|Standard Error of the Mean|3.12|<|0.0273|2-Sided||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663946|NCT01480076|3061848|Superiority or Other||difference of LS means|-6.8|Standard Error of the Mean|1.91|<|0.0004|2-Sided||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663947|NCT01480076|3061848|Superiority or Other||||||<|0.3673|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663948|NCT01480076|3061848|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663949|NCT01480076|3061848|Superiority or Other||||||<|0.8767|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663950|NCT01480076|3061848|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 psychological score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663951|NCT01480076|3061849|Superiority or Other||difference of LS means|-6.7|Standard Error of the Mean|4.08||0.0989|2-Sided||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663952|NCT01480076|3061849|Superiority or Other||difference of LS means|-5.7|Standard Error of the Mean|2.52||0.0251|2-Sided||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663953|NCT01480076|3061849|Superiority or Other|||||||0.2755|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663954|NCT01480076|3061849|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663955|NCT01480076|3061849|Superiority or Other||||||<|0.4087|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663956|NCT01480076|3061849|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663957|NCT01480076|3061849|Superiority or Other||difference of LS means|-12.3|Standard Error of the Mean|4.15|<|0.0033|2-Sided||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663958|NCT01480076|3061849|Superiority or Other||difference of LS means|-7.6|Standard Error of the Mean|2.44|<|0.0019|2-Sided||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663959|NCT01480076|3061849|Superiority or Other||||||<|0.9049|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663960|NCT01480076|3061849|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663961|NCT01480076|3061849|Superiority or Other||||||<|0.8703|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664447|NCT01479621|3061903|Superiority or Other||LSM difference|0.011||||0.7882|2-Sided|95.0|-0.068|0.089||Significance at 0.05|mixed model for repeated measures||||
1663962|NCT01480076|3061849|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663963|NCT01480076|3061849|Superiority or Other||difference of LS means|-7.0|Standard Error of the Mean|3.58|<|0.0511|2-Sided||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663964|NCT01480076|3061849|Superiority or Other||difference of LS means|-7.8|Standard Error of the Mean|2.22|<|0.0004|2-Sided||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663965|NCT01480076|3061849|Superiority or Other||||||<|0.1357|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663966|NCT01480076|3061849|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663967|NCT01480076|3061849|Superiority or Other||||||<|0.3435|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663968|NCT01480076|3061849|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663969|NCT01480076|3061849|Superiority or Other||difference of LS means|-10.0|Standard Error of the Mean|3.3|<|0.0026|2-Sided||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663970|NCT01480076|3061849|Superiority or Other||difference of LS means|-11.2|Standard Error of the Mean|2.0|<|0.0001|2-Sided||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663971|NCT01480076|3061849|Superiority or Other||||||<|0.2157|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663972|NCT01480076|3061849|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663973|NCT01480076|3061849|Superiority or Other||||||<|0.502|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663974|NCT01480076|3061849|Superiority or Other||difference of LS means|-12.6|Standard Error of the Mean|1.07|<|0.0001|2-Sided||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663975|NCT01480076|3061849|Superiority or Other||difference of LS means|-9.0|Standard Error of the Mean|3.16|<|0.0046|2-Sided||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1665208|NCT01462435|3064100|Superiority or Other|||||||0.002|||||||t-test, 2 sided||||
1663976|NCT01480076|3061849|Superiority or Other||difference of LS means|-8.1|Standard Error of the Mean|1.93|<|0.0001|2-Sided||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663977|NCT01480076|3061849|Superiority or Other||||||<|0.2949|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663978|NCT01480076|3061849|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663979|NCT01480076|3061849|Superiority or Other||||||<|0.454|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663980|NCT01480076|3061849|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the two-way and three-way interactions among them, baseline MSIS-29 physical score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663981|NCT01480076|3061850|Superiority or Other||difference of LS means|4.1|Standard Error of the Mean|2.23||0.0651|2-Sided||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663982|NCT01480076|3061850|Superiority or Other||difference of LS means|2.8|Standard Error of the Mean|1.38||0.0401|2-Sided||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663983|NCT01480076|3061850|Superiority or Other|||||||0.904|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663984|NCT01480076|3061850|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663985|NCT01480076|3061850|Superiority or Other||||||<|0.6004|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663986|NCT01480076|3061850|Superiority or Other||||||<|0.0006|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663987|NCT01480076|3061850|Superiority or Other||difference of LS means|2.8|Standard Error of the Mean|2.32|<|0.2281|2-Sided||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663988|NCT01480076|3061850|Superiority or Other||difference of LS means|0.8|Standard Error of the Mean|1.38|<|0.5561|2-Sided||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663989|NCT01480076|3061850|Superiority or Other||||||<|0.9862|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664448|NCT01479621|3061903|Superiority or Other||LSM difference|0.034||||0.4083|2-Sided|95.0|-0.046|0.114||Significance at 0.05|mixed model for repeated measures||||
1664770|NCT01474122|3062616|Superiority or Other||Odds Ratio (OR)|1.048||||0.9047|2-Sided|95.0|0.485|2.264|||Chi-squared||||
1663990|NCT01480076|3061850|Superiority or Other||||||<|0.0016|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663991|NCT01480076|3061850|Superiority or Other||||||<|0.3685|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663992|NCT01480076|3061850|Superiority or Other||||||<|0.0008|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663993|NCT01480076|3061850|Superiority or Other||difference of LS means|2.6|Standard Error of the Mean|2.03|<|0.2059|2-Sided||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663994|NCT01480076|3061850|Superiority or Other||difference of LS means|2.8|Standard Error of the Mean|1.27|<|0.0305|2-Sided||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663995|NCT01480076|3061850|Superiority or Other||||||<|0.4312|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663996|NCT01480076|3061850|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663997|NCT01480076|3061850|Superiority or Other||||||<|0.8627|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663998|NCT01480076|3061850|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1663999|NCT01480076|3061850|Superiority or Other||difference of LS means|3.7|Standard Error of the Mean|1.88|<|0.0476|2-Sided||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664000|NCT01480076|3061850|Superiority or Other||difference of LS means|5.2|Standard Error of the Mean|1.15|<|0.0001|2-Sided||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664001|NCT01480076|3061850|Superiority or Other||||||<|0.5556|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664002|NCT01480076|3061850|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664003|NCT01480076|3061850|Superiority or Other||||||<|0.274|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664004|NCT01480076|3061850|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664005|NCT01480076|3061850|Superiority or Other||difference of LS means|3.3|Standard Error of the Mean|1.68|<|0.049|2-Sided||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664006|NCT01480076|3061850|Superiority or Other||difference of LS means|2.9|Standard Error of the Mean|1.03|<|0.005|2-Sided||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664007|NCT01480076|3061850|Superiority or Other||||||<|0.7156|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664008|NCT01480076|3061850|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664009|NCT01480076|3061850|Superiority or Other||||||<|0.8999|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664010|NCT01480076|3061850|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline MCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664011|NCT01480076|3061851|Superiority or Other||difference of LS means|3.3|Standard Error of the Mean|1.49||0.0263|2-Sided||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664012|NCT01480076|3061851|Superiority or Other||difference of LS means|3.3|Standard Error of the Mean|0.93||0.0004|2-Sided||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664013|NCT01480076|3061851|Superiority or Other|||||||0.8626|||||||mixed effect model|||Month 12, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664014|NCT01480076|3061851|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664015|NCT01480076|3061851|Superiority or Other||||||<|0.4052|||||||mixed effect model|||Month 12, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664016|NCT01480076|3061851|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664017|NCT01480076|3061851|Superiority or Other||difference of LS means|4.7|Standard Error of the Mean|1.51|<|0.002|2-Sided||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664018|NCT01480076|3061851|Superiority or Other||difference of LS means|3.9|Standard Error of the Mean|0.9|<|0.0001|2-Sided||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy) versus Non- responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664449|NCT01479621|3061903|Superiority or Other||LSM difference|-0.114||||0.0058|2-Sided|95.0|-0.195|-0.033||Significance at 0.05|mixed model for repeated measures||||
1665209|NCT01462435|3064101|Superiority or Other|||||||0.053|||||||t-test, 2 sided||||
1664019|NCT01480076|3061851|Superiority or Other||||||<|0.6306|||||||mixed effect model|||Month 9, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664020|NCT01480076|3061851|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664021|NCT01480076|3061851|Superiority or Other||||||<|0.204|||||||mixed effect model|||Month 9, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664022|NCT01480076|3061851|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664023|NCT01480076|3061851|Superiority or Other||difference of LS means|4.6|Standard Error of the Mean|1.4|<|0.001|2-Sided||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664024|NCT01480076|3061851|Superiority or Other||difference of LS means|2.4|Standard Error of the Mean|0.88|<|0.0058|2-Sided||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664025|NCT01480076|3061851|Superiority or Other||||||<|0.5695|||||||mixed effect model|||Month 6, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664026|NCT01480076|3061851|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664027|NCT01480076|3061851|Superiority or Other||||||<|0.4668|||||||mixed effect model|||Month 6, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664028|NCT01480076|3061851|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664029|NCT01480076|3061851|Superiority or Other||difference of LS means|5.3|Standard Error of the Mean|1.23|<|0.0001|2-Sided||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664030|NCT01480076|3061851|Superiority or Other||difference of LS means|3.9|Standard Error of the Mean|0.75|<|0.0001|2-Sided||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664031|NCT01480076|3061851|Superiority or Other||||||<|0.3221|||||||mixed effect model|||Month 3, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664032|NCT01480076|3061851|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664033|NCT01480076|3061851|Superiority or Other||||||<|0.8886|||||||mixed effect model|||Month 3, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664034|NCT01480076|3061851|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664035|NCT01480076|3061851|Superiority or Other||difference of LS means|4.5|Standard Error of the Mean|1.1|<|0.0001|2-Sided||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy) versus Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664036|NCT01480076|3061851|Superiority or Other||difference of LS means|3.4|Standard Error of the Mean|0.68|<|0.0001|2-Sided||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy) versus Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664037|NCT01480076|3061851|Superiority or Other||||||<|0.578|||||||mixed effect model|||Overall, Non-responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664038|NCT01480076|3061851|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Not Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664039|NCT01480076|3061851|Superiority or Other||||||<|0.6769|||||||mixed effect model|||Overall, Non-responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664040|NCT01480076|3061851|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder (Taking Additional MS Therapy): Mixed effect model for repeated measures with visit, responder group, additional MS therapy, the 2-way and 3-way interactions among them, baseline PCS score, age, gender, country, baseline EDSS score and total number of relapses experienced as fixed effects. An unstructured covariance was used to model within-patient error.|
1664041|NCT01480076|3061852|Superiority or Other|||||||0.004|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664042|NCT01480076|3061852|Superiority or Other|||||||0.1151|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664043|NCT01480076|3061852|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664044|NCT01480076|3061852|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664045|NCT01480076|3061852|Superiority or Other||||||<|0.0161|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664046|NCT01480076|3061852|Superiority or Other||||||<|0.0026|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664047|NCT01480076|3061852|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664048|NCT01480076|3061852|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664450|NCT01479621|3061909|Superiority or Other|||||||0.001||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo|
1664451|NCT01479621|3061909|Superiority or Other|||||||0.0008||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo|
1664049|NCT01480076|3061852|Superiority or Other||||||<|0.0012|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664050|NCT01480076|3061852|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664051|NCT01480076|3061852|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664052|NCT01480076|3061852|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664053|NCT01480076|3061852|Superiority or Other||||||<|0.0102|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664054|NCT01480076|3061852|Superiority or Other||||||<|0.0002|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664055|NCT01480076|3061852|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664056|NCT01480076|3061852|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664057|NCT01480076|3061852|Superiority or Other||||||<|0.0003|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664058|NCT01480076|3061852|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664059|NCT01480076|3061852|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664060|NCT01480076|3061852|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of regular activity productivity loss, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664061|NCT01480076|3061853|Superiority or Other|||||||0.131|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664062|NCT01480076|3061853|Superiority or Other|||||||0.9237|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664063|NCT01480076|3061853|Superiority or Other|||||||0.5719|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664064|NCT01480076|3061853|Superiority or Other|||||||0.0652|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664452|NCT01479621|3061909|Superiority or Other||||||<|0.0001||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo|
1664065|NCT01480076|3061853|Superiority or Other|||||||0.3852|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664066|NCT01480076|3061853|Superiority or Other|||||||0.8315|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664067|NCT01480076|3061853|Superiority or Other|||||||0.5666|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664068|NCT01480076|3061853|Superiority or Other|||||||0.1628|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664069|NCT01480076|3061853|Superiority or Other|||||||0.4224|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664070|NCT01480076|3061853|Superiority or Other|||||||0.434|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664071|NCT01480076|3061853|Superiority or Other|||||||0.0011|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664072|NCT01480076|3061853|Superiority or Other|||||||0.0013|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664073|NCT01480076|3061853|Superiority or Other|||||||0.7639|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664074|NCT01480076|3061853|Superiority or Other|||||||0.6924|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664075|NCT01480076|3061853|Superiority or Other|||||||0.0039|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664076|NCT01480076|3061853|Superiority or Other|||||||0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664077|NCT01480076|3061853|Superiority or Other|||||||0.3526|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664078|NCT01480076|3061853|Superiority or Other|||||||0.8135|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664079|NCT01480076|3061853|Superiority or Other|||||||0.0299|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664080|NCT01480076|3061853|Superiority or Other|||||||0.0022|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of overall work impairment due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664453|NCT01479621|3061909|Superiority or Other||||||<|0.2841||||||Significance at 0.05|Log Rank|||Comparison of survival curve to placebo|
1664081|NCT01480076|3061854|Superiority or Other|||||||0.1187|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664082|NCT01480076|3061854|Superiority or Other|||||||0.0849|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664083|NCT01480076|3061854|Superiority or Other|||||||0.6673|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664084|NCT01480076|3061854|Superiority or Other|||||||0.2539|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664085|NCT01480076|3061854|Superiority or Other|||||||0.5675|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664086|NCT01480076|3061854|Superiority or Other|||||||0.8936|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664087|NCT01480076|3061854|Superiority or Other|||||||0.5757|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664088|NCT01480076|3061854|Superiority or Other|||||||0.0446|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664089|NCT01480076|3061854|Superiority or Other|||||||0.2275|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664090|NCT01480076|3061854|Superiority or Other|||||||0.4385|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664091|NCT01480076|3061854|Superiority or Other|||||||0.0021|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664092|NCT01480076|3061854|Superiority or Other|||||||0.0025|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664093|NCT01480076|3061854|Superiority or Other|||||||0.6987|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664094|NCT01480076|3061854|Superiority or Other|||||||0.6258|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664095|NCT01480076|3061854|Superiority or Other|||||||0.0061|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664096|NCT01480076|3061854|Superiority or Other|||||||0.0002|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664477|NCT01479530|3061930|Superiority or Other||Median Difference (Final Values)|-0.5|Standard Error of the Mean|0.22||0.0228|2-Sided|95.0|-0.92|-0.07|||ANCOVA||||
1664097|NCT01480076|3061854|Superiority or Other|||||||0.22|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664098|NCT01480076|3061854|Superiority or Other|||||||0.7756|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664099|NCT01480076|3061854|Superiority or Other|||||||0.0828|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664100|NCT01480076|3061854|Superiority or Other|||||||0.0032|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of impairment while working due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664101|NCT01480076|3061855|Superiority or Other|||||||0.744|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664102|NCT01480076|3061855|Superiority or Other|||||||0.5875|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664103|NCT01480076|3061855|Superiority or Other|||||||0.9679|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664104|NCT01480076|3061855|Superiority or Other|||||||0.9057|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664105|NCT01480076|3061855|Superiority or Other|||||||0.254|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664106|NCT01480076|3061855|Superiority or Other|||||||0.802|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664107|NCT01480076|3061855|Superiority or Other|||||||0.5848|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664108|NCT01480076|3061855|Superiority or Other|||||||0.507|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664109|NCT01480076|3061855|Superiority or Other|||||||0.7155|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664110|NCT01480076|3061855|Superiority or Other|||||||0.2975|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664111|NCT01480076|3061855|Superiority or Other|||||||0.0594|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664112|NCT01480076|3061855|Superiority or Other|||||||0.0046|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664478|NCT01479478|3061952|Superiority|||||||0.87|||||||Cochran-Mantel-Haenszel||||
1664771|NCT01474122|3062616|Superiority or Other||Odds Ratio (OR)|1.216||||0.6117|2-Sided|95.0|0.572|2.582|||Chi-squared||||
1664115|NCT01480076|3061855|Superiority or Other|||||||0.4149|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664116|NCT01480076|3061855|Superiority or Other|||||||0.2166|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664117|NCT01480076|3061855|Superiority or Other|||||||0.4893|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664118|NCT01480076|3061855|Superiority or Other|||||||0.3854|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664119|NCT01480076|3061855|Superiority or Other|||||||0.5503|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664120|NCT01480076|3061855|Superiority or Other|||||||0.1471|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of percentage of work time missed due to MS, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664121|NCT01480076|3061856|Superiority or Other|||||||0.0076|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664122|NCT01480076|3061856|Superiority or Other|||||||0.0219|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664123|NCT01480076|3061856|Superiority or Other|||||||0.0386|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664124|NCT01480076|3061856|Superiority or Other|||||||0.0097|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664125|NCT01480076|3061856|Superiority or Other|||||||0.6475|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664126|NCT01480076|3061856|Superiority or Other|||||||0.0445|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664127|NCT01480076|3061856|Superiority or Other|||||||0.1937|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664128|NCT01480076|3061856|Superiority or Other|||||||0.0009|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664129|NCT01480076|3061856|Superiority or Other|||||||0.0106|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664130|NCT01480076|3061856|Superiority or Other|||||||0.019|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664234|NCT01480076|3061861|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664131|NCT01480076|3061856|Superiority or Other|||||||0.0004|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664132|NCT01480076|3061856|Superiority or Other|||||||0.0018|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664133|NCT01480076|3061856|Superiority or Other|||||||0.0669|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664134|NCT01480076|3061856|Superiority or Other|||||||0.0024|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664135|NCT01480076|3061856|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664136|NCT01480076|3061856|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664137|NCT01480076|3061856|Superiority or Other||||||<|0.0167|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664138|NCT01480076|3061856|Superiority or Other||||||<|0.0027|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664139|NCT01480076|3061856|Superiority or Other||||||<|0.0005|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664140|NCT01480076|3061856|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664141|NCT01480076|3061857|Superiority or Other|||||||0.1853|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664142|NCT01480076|3061857|Superiority or Other|||||||0.0011|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664143|NCT01480076|3061857|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664144|NCT01480076|3061857|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664145|NCT01480076|3061857|Superiority or Other||||||<|0.0887|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664146|NCT01480076|3061857|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664147|NCT01480076|3061857|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664148|NCT01480076|3061857|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664149|NCT01480076|3061857|Superiority or Other||||||<|0.185|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664150|NCT01480076|3061857|Superiority or Other||||||<|0.0003|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664151|NCT01480076|3061857|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664152|NCT01480076|3061857|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664153|NCT01480076|3061857|Superiority or Other||||||<|0.1138|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664154|NCT01480076|3061857|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664155|NCT01480076|3061857|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664156|NCT01480076|3061857|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664157|NCT01480076|3061857|Superiority or Other||||||<|0.0649|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664158|NCT01480076|3061857|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664159|NCT01480076|3061857|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664160|NCT01480076|3061857|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the current health state of EQ-5D scores, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664161|NCT01480076|3061858|Superiority or Other|||||||0.225|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664162|NCT01480076|3061858|Superiority or Other|||||||0.1977|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664163|NCT01480076|3061858|Superiority or Other|||||||0.1978|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664164|NCT01480076|3061858|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1665210|NCT01462435|3064101|Superiority or Other|||||||0.091|||||||t-test, 2 sided||||
1664165|NCT01480076|3061858|Superiority or Other||||||<|0.0235|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664166|NCT01480076|3061858|Superiority or Other||||||<|0.4699|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664167|NCT01480076|3061858|Superiority or Other||||||<|0.0455|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664168|NCT01480076|3061858|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664169|NCT01480076|3061858|Superiority or Other||||||<|0.0749|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664170|NCT01480076|3061858|Superiority or Other||||||<|0.1012|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664171|NCT01480076|3061858|Superiority or Other||||||<|0.0002|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664172|NCT01480076|3061858|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664173|NCT01480076|3061858|Superiority or Other||||||<|0.0157|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664174|NCT01480076|3061858|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664175|NCT01480076|3061858|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664176|NCT01480076|3061858|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664177|NCT01480076|3061858|Superiority or Other||||||<|0.0192|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664178|NCT01480076|3061858|Superiority or Other||||||<|0.1754|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664179|NCT01480076|3061858|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664180|NCT01480076|3061858|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline of the total ALS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-patient error.|
1664181|NCT01480076|3061859|Superiority or Other|||||||0.1227|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664717|NCT01474512|3062510|Superiority or Other (legacy)||||||<|0.001||||||P-value is for PPASI75|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664182|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664183|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664184|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664185|NCT01480076|3061859|Superiority or Other||||||<|0.0103|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664186|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664187|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664188|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664189|NCT01480076|3061859|Superiority or Other||||||<|0.0097|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664190|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664191|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664192|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664193|NCT01480076|3061859|Superiority or Other||||||<|0.0021|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664194|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664195|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664196|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664197|NCT01480076|3061859|Superiority or Other||||||<|0.0032|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664198|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664772|NCT01474122|3062617|Superiority or Other||Odds Ratio (OR)|0.789||||0.4624|2-Sided|95.0|0.42|1.484|||Chi-squared||||
1664199|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664200|NCT01480076|3061859|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 psychological score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664201|NCT01480076|3061860|Superiority or Other|||||||0.0002|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664202|NCT01480076|3061860|Superiority or Other|||||||0.0002|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664203|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664204|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664205|NCT01480076|3061860|Superiority or Other||||||<|0.0009|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664206|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664207|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664208|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664209|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664210|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664211|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664212|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664213|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664214|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664215|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664718|NCT01474512|3062510|Superiority or Other (legacy)||||||<|0.001||||||P-value is for PPASI75|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664216|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664217|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664218|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664219|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664220|NCT01480076|3061860|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MSIS-29 physical score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664221|NCT01480076|3061861|Superiority or Other|||||||0.7714|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664222|NCT01480076|3061861|Superiority or Other|||||||0.0052|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664223|NCT01480076|3061861|Superiority or Other|||||||0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664224|NCT01480076|3061861|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664225|NCT01480076|3061861|Superiority or Other||||||<|0.2489|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664226|NCT01480076|3061861|Superiority or Other||||||<|0.0037|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664227|NCT01480076|3061861|Superiority or Other||||||<|0.0019|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664228|NCT01480076|3061861|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664229|NCT01480076|3061861|Superiority or Other||||||<|0.076|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664230|NCT01480076|3061861|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664231|NCT01480076|3061861|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664232|NCT01480076|3061861|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664520|NCT01478594|3062046|Superiority or Other||Hazard Ratio (HR)|0.915|||||2-Sided|95.0|0.334|2.512|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664236|NCT01480076|3061861|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664237|NCT01480076|3061861|Superiority or Other||||||<|0.1398|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664238|NCT01480076|3061861|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664239|NCT01480076|3061861|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664240|NCT01480076|3061861|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline MCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664241|NCT01480076|3061862|Superiority or Other|||||||0.0118|||||||mixed effect model|||Month 12, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664242|NCT01480076|3061862|Superiority or Other|||||||0.0047|||||||mixed effect model|||Month 12, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664243|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664244|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664245|NCT01480076|3061862|Superiority or Other||||||<|0.004|||||||mixed effect model|||Month 9, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664246|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664247|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664248|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664249|NCT01480076|3061862|Superiority or Other||||||<|0.0006|||||||mixed effect model|||Month 6, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664250|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664251|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664252|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664253|NCT01480076|3061862|Superiority or Other||||||<|0.0069|||||||mixed effect model|||Month 3, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664254|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664255|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664256|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664257|NCT01480076|3061862|Superiority or Other||||||<|0.0004|||||||mixed effect model|||Overall, PRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664258|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, PPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664259|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, SPMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664260|NCT01480076|3061862|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, RRMS. Mixed effect model for repeated measures with visit, baseline PCS score, MS type, age, gender, country, visit and MS type interaction, baseline EDSS score and total number of relapses experienced within the past 12 months as fixed effects. An unstructured covariance was used to model within-participant error.|
1664261|NCT01480076|3061863|Superiority or Other||least squares mean|-4.8|Standard Error of the Mean|3.14||0.1259|2-Sided||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664262|NCT01480076|3061863|Superiority or Other|||||||0.1714|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664263|NCT01480076|3061863|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664264|NCT01480076|3061863|Superiority or Other||least squares mean|-6.3|Standard Error of the Mean|3.02|<|0.0364|2-Sided||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664265|NCT01480076|3061863|Superiority or Other||||||<|0.1838|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664266|NCT01480076|3061863|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664267|NCT01480076|3061863|Superiority or Other||least squares mean|-7.6|Standard Error of the Mean|2.87|<|0.0082|2-Sided||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664268|NCT01480076|3061863|Superiority or Other||||||<|0.1078|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664269|NCT01480076|3061863|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664270|NCT01480076|3061863|Superiority or Other||least squares mean|-10.4|Standard Error of the Mean|2.76|<|0.0002|2-Sided||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664271|NCT01480076|3061863|Superiority or Other||||||<|0.2777|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664272|NCT01480076|3061863|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664273|NCT01480076|3061863|Superiority or Other||least squares mean|-7.3|Standard Error of the Mean|2.2|<|0.001|2-Sided||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664274|NCT01480076|3061863|Superiority or Other||||||<|0.086|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664275|NCT01480076|3061863|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of regular activity productivity loss due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664276|NCT01480076|3061864|Superiority or Other||least squares mean|8.8|Standard Error of the Mean|7.13||0.2194|2-Sided||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664277|NCT01480076|3061864|Superiority or Other|||||||0.0994|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664278|NCT01480076|3061864|Superiority or Other|||||||0.2422|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664279|NCT01480076|3061864|Superiority or Other||least squares mean|13.5|Standard Error of the Mean|9.98||0.1781|2-Sided||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664280|NCT01480076|3061864|Superiority or Other|||||||0.1077|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664281|NCT01480076|3061864|Superiority or Other|||||||0.4027|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664282|NCT01480076|3061864|Superiority or Other||least squares mean|-4.8|Standard Error of the Mean|6.77||0.477|2-Sided||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664283|NCT01480076|3061864|Superiority or Other|||||||0.6631|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664521|NCT01478594|3062047|Superiority or Other||Hazard Ratio (HR)|1.22|||||2-Sided|95.0|0.462|3.22|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664284|NCT01480076|3061864|Superiority or Other|||||||0.0016|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664285|NCT01480076|3061864|Superiority or Other||least squares mean|-3.2|Standard Error of the Mean|6.64||0.6283|2-Sided||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664286|NCT01480076|3061864|Superiority or Other|||||||0.4968|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664287|NCT01480076|3061864|Superiority or Other|||||||0.0022|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664288|NCT01480076|3061864|Superiority or Other||least squares mean|3.6|Standard Error of the Mean|5.68||0.5312|2-Sided||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664289|NCT01480076|3061864|Superiority or Other|||||||0.1259|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664290|NCT01480076|3061864|Superiority or Other|||||||0.0219|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage overall work impairment due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664291|NCT01480076|3061865|Superiority or Other||least squares mean|8.1|Standard Error of the Mean|6.86||0.2392|2-Sided||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664292|NCT01480076|3061865|Superiority or Other|||||||0.217|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664293|NCT01480076|3061865|Superiority or Other|||||||0.8806|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664294|NCT01480076|3061865|Superiority or Other||least squares mean|14.9|Standard Error of the Mean|6.83||0.0297|2-Sided||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664295|NCT01480076|3061865|Superiority or Other|||||||0.0089|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664296|NCT01480076|3061865|Superiority or Other|||||||0.1696|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664297|NCT01480076|3061865|Superiority or Other||least squares mean|-0.9|Standard Error of the Mean|5.34||0.8735|2-Sided||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664522|NCT01478594|3062047|Superiority or Other||Hazard Ratio (HR)|0.921|||||2-Sided|95.0|0.356|2.385|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664298|NCT01480076|3061865|Superiority or Other|||||||0.2967|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664299|NCT01480076|3061865|Superiority or Other|||||||0.0015|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664300|NCT01480076|3061865|Superiority or Other||least squares mean|-5.1|Standard Error of the Mean|5.53||0.3592|2-Sided||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664301|NCT01480076|3061865|Superiority or Other|||||||0.749|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664302|NCT01480076|3061865|Superiority or Other|||||||0.0012|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664303|NCT01480076|3061865|Superiority or Other||least squares mean|4.3|Standard Error of the Mean|4.47||0.34|2-Sided||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664304|NCT01480076|3061865|Superiority or Other|||||||0.0654|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664305|NCT01480076|3061865|Superiority or Other|||||||0.0281|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage impairment while working due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664306|NCT01480076|3061866|Superiority or Other||least squares mean|11.4|Standard Error of the Mean|6.65||0.0876|2-Sided||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664307|NCT01480076|3061866|Superiority or Other|||||||0.0653|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664308|NCT01480076|3061866|Superiority or Other|||||||0.7533|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664309|NCT01480076|3061866|Superiority or Other||least squares mean|8.5|Standard Error of the Mean|7.91||0.2814|2-Sided||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664310|NCT01480076|3061866|Superiority or Other|||||||0.2176|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664311|NCT01480076|3061866|Superiority or Other|||||||0.6441|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664326|NCT01480076|3061867|Superiority or Other|||||||0.0027|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664312|NCT01480076|3061866|Superiority or Other||least squares mean|2.3|Standard Error of the Mean|5.09||0.6468|2-Sided||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664313|NCT01480076|3061866|Superiority or Other|||||||0.1343|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664314|NCT01480076|3061866|Superiority or Other|||||||0.0073|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664315|NCT01480076|3061866|Superiority or Other||least squares mean|1.0|Standard Error of the Mean|5.89||0.8611|2-Sided||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664316|NCT01480076|3061866|Superiority or Other|||||||0.4894|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664317|NCT01480076|3061866|Superiority or Other|||||||0.1649|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664318|NCT01480076|3061866|Superiority or Other||least squares mean|5.8|Standard Error of the Mean|4.6||0.2065|2-Sided||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664319|NCT01480076|3061866|Superiority or Other|||||||0.0715|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664320|NCT01480076|3061866|Superiority or Other|||||||0.1795|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of percentage of work time missed due to MS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664321|NCT01480076|3061867|Superiority or Other||least squares mean|0.05|Standard Error of the Mean|0.03||0.0917|2-Sided||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664322|NCT01480076|3061867|Superiority or Other|||||||0.8502|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664323|NCT01480076|3061867|Superiority or Other|||||||0.0007|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664324|NCT01480076|3061867|Superiority or Other||least squares mean|0.03|Standard Error of the Mean|0.03||0.2638|2-Sided||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664325|NCT01480076|3061867|Superiority or Other|||||||0.8053|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664431|NCT01480076|3061874|Superiority or Other||||||<|0.0001||||||within group p-value|mixed effect model|||Month 6: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664327|NCT01480076|3061867|Superiority or Other||least squares mean|0.04|Standard Error of the Mean|0.02||0.0679|2-Sided||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664328|NCT01480076|3061867|Superiority or Other|||||||0.7949|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664329|NCT01480076|3061867|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664330|NCT01480076|3061867|Superiority or Other||least squares mean|0.06|Standard Error of the Mean|0.02|<|0.0042|2-Sided||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664331|NCT01480076|3061867|Superiority or Other||||||<|0.6956|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664332|NCT01480076|3061867|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664333|NCT01480076|3061867|Superiority or Other||least squares mean|0.04|Standard Error of the Mean|0.02|<|0.0162|2-Sided||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664334|NCT01480076|3061867|Superiority or Other||||||<|0.8392|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664335|NCT01480076|3061867|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664336|NCT01480076|3061868|Superiority or Other||least squares mean|12.3|Standard Error of the Mean|2.29|<|0.0001|2-Sided||||||mixed effect model|||Month 12, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664337|NCT01480076|3061868|Superiority or Other||||||<|0.0108|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664338|NCT01480076|3061868|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664339|NCT01480076|3061868|Superiority or Other||least squares mean|11.2|Standard Error of the Mean|2.16|<|0.0001|2-Sided||||||mixed effect model|||Month 9, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664340|NCT01480076|3061868|Superiority or Other||||||<|0.0284|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664432|NCT01480076|3061874|Superiority or Other||||||<|0.0001||||||within group p-value|mixed effect model|||Month 3: Mixed effect model for repeated measures with visit, baseline PCS score, baseline Expanded Disability Status Scale (EDSS) score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664341|NCT01480076|3061868|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664342|NCT01480076|3061868|Superiority or Other||least squares mean|9.7|Standard Error of the Mean|2.0|<|0.0001|2-Sided||||||mixed effect model|||Month 6, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664343|NCT01480076|3061868|Superiority or Other||||||<|0.0789|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664344|NCT01480076|3061868|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664345|NCT01480076|3061868|Superiority or Other||least squares mean|11.1|Standard Error of the Mean|1.82|<|0.0001|2-Sided||||||mixed effect model|||Month 3, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664346|NCT01480076|3061868|Superiority or Other||||||<|0.097|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664347|NCT01480076|3061868|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664348|NCT01480076|3061868|Superiority or Other||least squares mean|11.1|Standard Error of the Mean|1.61|<|0.0001|2-Sided||||||mixed effect model|||Overall, Responder Versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664349|NCT01480076|3061868|Superiority or Other||||||<|0.0111|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664350|NCT01480076|3061868|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the current health state of EQ-5D scores, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664351|NCT01480076|3061869|Superiority or Other||least squares mean|-1.9|Standard Error of the Mean|0.84||0.0246|2-Sided||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664352|NCT01480076|3061869|Superiority or Other|||||||0.1758|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664353|NCT01480076|3061869|Superiority or Other|||||||0.0033|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664354|NCT01480076|3061869|Superiority or Other||least squares mean|-3.1|Standard Error of the Mean|0.75|<|0.0001|2-Sided||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664433|NCT01479764|3061898|Superiority or Other||Estimated Ratio of Geometric Means|0.83||||0.021|2-Sided|95.0|0.71|0.97|||ANCOVA|Adjusted for age, American Society of Anesthesiologists class, Body Mass Index, comorbidity index & length of surgical procedure||Sugammadex is the numerator and neostigmine/glycopyrrolate is the denominator. Used log-transformed time intervals.|
1664355|NCT01480076|3061869|Superiority or Other||||||<|0.0126|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664356|NCT01480076|3061869|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664357|NCT01480076|3061869|Superiority or Other||least squares mean|-2.2|Standard Error of the Mean|0.71|<|0.0017|2-Sided||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664358|NCT01480076|3061869|Superiority or Other||||||<|0.2489|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664359|NCT01480076|3061869|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error|
1664360|NCT01480076|3061869|Superiority or Other||least squares mean|-1.9|Standard Error of the Mean|0.59|<|0.0016|2-Sided||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664361|NCT01480076|3061869|Superiority or Other||||||<|0.4759|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664362|NCT01480076|3061869|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664363|NCT01480076|3061869|Superiority or Other||least squares mean|-2.3|Standard Error of the Mean|0.56|<|0.0001|2-Sided||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664364|NCT01480076|3061869|Superiority or Other||||||<|0.1324|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664365|NCT01480076|3061869|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder group, visit and responder group interaction, baseline of the total activity limitation score of PRIMUS, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664366|NCT01480076|3061870|Superiority or Other||least squares mean|-6.4|Standard Error of the Mean|2.28||0.0049|2-Sided||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664367|NCT01480076|3061870|Superiority or Other|||||||0.8202|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664368|NCT01480076|3061870|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664430|NCT01480076|3061874|Superiority or Other||least squares mean|0.8|Standard Error of the Mean|0.22|<|0.0007|2-Sided||||||mixed effect model|||Difference of Month 3 versus Month 6: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664369|NCT01480076|3061870|Superiority or Other||least squares mean|-6.0|Standard Error of the Mean|2.2|<|0.0066|2-Sided||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664370|NCT01480076|3061870|Superiority or Other||||||<|0.7134|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664371|NCT01480076|3061870|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664372|NCT01480076|3061870|Superiority or Other||least squares mean|-5.1|Standard Error of the Mean|1.98|<|0.0102|2-Sided||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664373|NCT01480076|3061870|Superiority or Other||||||<|0.2008|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664374|NCT01480076|3061870|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664375|NCT01480076|3061870|Superiority or Other||least squares mean|-9.4|Standard Error of the Mean|1.82|<|0.0001|2-Sided||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664376|NCT01480076|3061870|Superiority or Other||||||<|0.9365|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664377|NCT01480076|3061870|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664378|NCT01480076|3061870|Superiority or Other||least squares mean|-6.7|Standard Error of the Mean|1.64|<|0.0001|2-Sided||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664379|NCT01480076|3061870|Superiority or Other||||||<|0.5577|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664380|NCT01480076|3061870|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 psychological score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664381|NCT01480076|3061871|Superiority or Other||least squares mean|-5.8|Standard Error of the Mean|2.16||0.0072|2-Sided||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664382|NCT01480076|3061871|Superiority or Other|||||||0.2111|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664383|NCT01480076|3061871|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664768|NCT01474122|3062615|Superiority or Other||Mean Difference (Net)|-0.1||||0.165|2-Sided|95.0|-0.3|0.0|||ANCOVA||||
1664384|NCT01480076|3061871|Superiority or Other||least squares mean|-8.6|Standard Error of the Mean|2.12|<|0.0001|2-Sided||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664385|NCT01480076|3061871|Superiority or Other||||||<|0.8858|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664386|NCT01480076|3061871|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664387|NCT01480076|3061871|Superiority or Other||least squares mean|-7.6|Standard Error of the Mean|1.9|<|0.0001|2-Sided||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664388|NCT01480076|3061871|Superiority or Other||||||<|0.1262|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664389|NCT01480076|3061871|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664390|NCT01480076|3061871|Superiority or Other||least squares mean|-10.9|Standard Error of the Mean|1.72|<|0.0001|2-Sided||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664391|NCT01480076|3061871|Superiority or Other||||||<|0.2422|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664392|NCT01480076|3061871|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664393|NCT01480076|3061871|Superiority or Other||least squares mean|-8.2|Standard Error of the Mean|1.66|<|0.0001|2-Sided||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664394|NCT01480076|3061871|Superiority or Other||||||<|0.2475|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664395|NCT01480076|3061871|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MSIS-29 physical score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664396|NCT01480076|3061872|Superiority or Other||least squares mean|3.1|Standard Error of the Mean|1.18||0.009|2-Sided||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664397|NCT01480076|3061872|Superiority or Other|||||||0.6453|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664398|NCT01480076|3061872|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664434|NCT01479764|3061899|Superiority or Other||Odds Ratio (OR)|0.0|||<|0.0001|2-Sided|95.0|0.0|0.059|||Pearson's Chi-square test|||Sugammadex is the numerator and Neostigmine/Glycopyrrolate is the denominator.|
1664399|NCT01480076|3061872|Superiority or Other||least squares mean|1.3|Standard Error of the Mean|1.19|<|0.274|2-Sided||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664400|NCT01480076|3061872|Superiority or Other||||||<|0.4138|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664401|NCT01480076|3061872|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664402|NCT01480076|3061872|Superiority or Other||least squares mean|2.7|Standard Error of the Mean|1.08|<|0.014|2-Sided||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664403|NCT01480076|3061872|Superiority or Other||||||<|0.581|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664404|NCT01480076|3061872|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664405|NCT01480076|3061872|Superiority or Other||least squares mean|4.8|Standard Error of the Mean|0.99|<|0.0001|2-Sided||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664406|NCT01480076|3061872|Superiority or Other||||||<|0.5542|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664407|NCT01480076|3061872|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664408|NCT01480076|3061872|Superiority or Other||least squares mean|3.0|Standard Error of the Mean|0.89|<|0.0009|2-Sided||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664409|NCT01480076|3061872|Superiority or Other||||||<|0.9073|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664410|NCT01480076|3061872|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline MCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664411|NCT01480076|3061873|Superiority or Other||least squares mean|3.3|Standard Error of the Mean|0.79|<|0.0001|2-Sided||||||mixed effect model|||Month 12, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664412|NCT01480076|3061873|Superiority or Other||||||<|0.546|||||||mixed effect model|||Month 12, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664413|NCT01480076|3061873|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 12, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664435|NCT01479621|3061901|Superiority or Other||LSM difference|3.05||||0.6237|2-Sided|95.0|-9.16|15.26||Significance at 0.05|mixed model for repeated measures||||
1664436|NCT01479621|3061901|Superiority or Other||LSM difference|-5.98||||0.3292|2-Sided|95.0|-18.01|6.05||Significance at 0.05|mixed model for repeated measures||||
1664414|NCT01480076|3061873|Superiority or Other||least squares mean|4.1|Standard Error of the Mean|0.78|<|0.0001|2-Sided||||||mixed effect model|||Month 9, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664415|NCT01480076|3061873|Superiority or Other||||||<|0.1877|||||||mixed effect model|||Month 9, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664416|NCT01480076|3061873|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 9, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664417|NCT01480076|3061873|Superiority or Other||least squares mean|3.0|Standard Error of the Mean|0.75|<|0.0001|2-Sided||||||mixed effect model|||Month 6, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664418|NCT01480076|3061873|Superiority or Other||||||<|0.7484|||||||mixed effect model|||Month 6, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664419|NCT01480076|3061873|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 6, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664420|NCT01480076|3061873|Superiority or Other||least squares mean|4.3|Standard Error of the Mean|0.64|<|0.0001|2-Sided||||||mixed effect model|||Month 3, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664421|NCT01480076|3061873|Superiority or Other||||||<|0.7272|||||||mixed effect model|||Month 3, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664422|NCT01480076|3061873|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Month 3, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664423|NCT01480076|3061873|Superiority or Other||least squares mean|3.7|Standard Error of the Mean|0.58|<|0.0001|2-Sided||||||mixed effect model|||Overall, Responder versus Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664424|NCT01480076|3061873|Superiority or Other||||||<|0.5405|||||||mixed effect model|||Overall, Non-responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664425|NCT01480076|3061873|Superiority or Other||||||<|0.0001|||||||mixed effect model|||Overall, Responder: Mixed effect model for repeated measures with visit, responder status, visit by responder status interaction, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664426|NCT01480076|3061874|Superiority or Other||least squares mean|0.3|Standard Error of the Mean|0.21||0.2299|2-Sided||||||mixed effect model|||Difference of Month 9 versus Month 12: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664427|NCT01480076|3061874|Superiority or Other||||||<|0.0001||||||within group p-value|mixed effect model|||Month 12: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664428|NCT01480076|3061874|Superiority or Other||least squares mean|0.2|Standard Error of the Mean|0.21|<|0.2531|2-Sided||||||mixed effect model|||Difference of Month 6 versus Month 9: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664429|NCT01480076|3061874|Superiority or Other||||||<|0.0001||||||within-group p-value|mixed effect model|||Month 9: Mixed effect model for repeated measures with visit, baseline PCS score, baseline EDSS score, MS disease type, age, gender, total number of relapses experienced within the past 12 months and country as fixed effects. An unstructured covariance was used to model within-patient error.|
1664454|NCT01479621|3061910|Superiority or Other||Slope|12.78||||0.03825|2-Sided|95.0|0.44|25.11||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.|
1664455|NCT01479621|3061910|Superiority or Other||estimated mean difference from placebo|10.45||||0.09964|2-Sided|95.0|-2.24|23.15||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.|
1664456|NCT01479621|3061910|Superiority or Other||estimated mean difference from placebo|6.76||||0.26741|2-Sided|95.0|-5.43|18.94||The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.|GEE|||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.|
1664457|NCT01479621|3061910|Superiority or Other||estimated mean difference from placebo|2.76||||0.66685|2-Sided|95.0|-10.07|15.6|||GEE|The model contained covariates for sex, age, and treatment. The baseline level was estimated for all subjects combined, adjusted for covariates.||The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. This model was used to obtain 2-sided 95% confidence limits for the difference in treatment effects of Fp MDPI versus placebo.|
1664458|NCT01479621|3061911|Superiority or Other||LSM difference|18.23||||0.0046|2-Sided|95.0|5.64|30.82||Significance at 0.05|mixed model for repeated measures||||
1664459|NCT01479621|3061911|Superiority or Other||LSM difference|9.28||||0.1428|2-Sided|95.0|-3.14|21.69||Significance at 0.05|mixed model for repeated measures||||
1664460|NCT01479621|3061911|Superiority or Other||LSM difference|12.78||||0.0411|2-Sided|95.0|0.52|25.04||Significance at 0.05|mixed model for repeated measures||||
1664461|NCT01479621|3061911|Superiority or Other||LSM difference|11.06||||0.0852|2-Sided|95.0|-1.54|23.66||Significance at 0.05|mixed model for repeated measures||||
1664462|NCT01479621|3061911|Superiority or Other|||||||0.0434||||||Significance at 0.05|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo).|
1664463|NCT01479621|3061912|Superiority or Other||LSM difference|21.72||||0.0011|2-Sided|95.0|8.73|34.72||Significance at 0.05|mixed model for repeated measures||||
1664464|NCT01479621|3061912|Superiority or Other||LSM difference|11.75||||0.0741|2-Sided|95.0|-1.15|24.64||Significance at 0.05|mixed model for repeated measures||||
1664465|NCT01479621|3061912|Superiority or Other||LSM difference|20.32||||0.0018|2-Sided|95.0|7.61|33.03||Significance at 0.05|mixed model for repeated measures||||
1664466|NCT01479621|3061912|Superiority or Other||LSM difference|18.29||||0.006|2-Sided|95.0|5.28|31.29||Significance at 0.05|mixed model for repeated measures||||
1664467|NCT01479621|3061912|Superiority or Other|||||||0.0017||||||Significance at 0.05|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo).|
1664468|NCT01479621|3061913|Superiority or Other||LSM difference|0.052||||0.2227|2-Sided|95.0|-0.032|0.136|||mixed model for repeated measures|||This is the fifth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.|
1664469|NCT01479621|3061913|Superiority or Other||LSM difference|0.111||||0.0086|2-Sided|95.0|0.028|0.194|||mixed model for repeated measures|||This is the fourth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.|
1664470|NCT01479621|3061913|Superiority or Other||LSM difference|0.126||||0.0027|2-Sided|95.0|0.044|0.208|||mixed model for repeated measures|||This is the third analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.|
1664471|NCT01479621|3061913|Superiority or Other||LSM difference|0.149||||0.0005|2-Sided|95.0|0.066|0.233||The study was considered positive if the trend test was positive and the test involving the highest Fp MDPI dose (100 mcg twice daily) indicated significantly greater time averaged FEV1 mean than placebo.|mixed model for repeated measures|||This is the second analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level.|
1664472|NCT01479621|3061913|Superiority or Other|||||||0.0001||||||The study was considered positive if the trend test was positive and the test involving the highest Fp MDPI dose (100 mcg twice daily) indicated significantly greater time averaged FEV1 mean than placebo.|Regression, Linear|||A linear in log-dose trend contrast evaluated the time-averaged dose-response trend, where the logarithm of dose was defined as log(dose+1) to accommodate the case of a zero dose (placebo). A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level. Specifically, the 2-sided linear in log-dose time-averaged trend test was first performed followed by pairwise comparisons of each Fp MDPI dose versus placebo.|
1664473|NCT01479595|3061924|Superiority or Other||Mean Difference (Net)|-0.514||||0.005|2-Sided|90.0|-0.811|-0.217|||Mixed Models Analysis||||
1664474|NCT01479530|3061927|Superiority or Other||Median Difference (Final Values)|-1.6|Standard Error of the Mean|0.74||0.0317|2-Sided|95.0|-3.05|-0.14|||ANCOVA||||
1664475|NCT01479530|3061928|Superiority or Other||Mean Difference (Final Values)|-1.01|Standard Error of the Mean|0.37||0.0075|2-Sided|95.0|-1.75|-0.27|||ANCOVA||||
1664476|NCT01479530|3061929|Superiority or Other||Mean Difference (Final Values)|-0.41|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.61|-0.22|||ANCOVA||||
1665211|NCT01462435|3064101|Superiority or Other|||||||0.009|||||||t-test, 2 sided||||
1664479|NCT01479465|3061955|Superiority||Hazard Ratio (HR)|1.32||||0.1042|2-Sided|95.0|0.92|1.89|||Log Rank|||"The null hypothesis was that the HR equals to 1 between SIM treatment arm and placebo, while the alternative hypothesis was that HR was less than 1.~The HR (95% CI) and p-value (for comparison between SIM treatment arm and placebo) were based on two-sided log-rank test, stratified based on the 2-level ECOG performance status (0 or > 0) at randomization."|
1664480|NCT01479465|3061955|Superiority||Hazard Ratio (HR)|1.45||||0.0395|2-Sided|95.0|1.01|2.06|||Log Rank|||"The null hypothesis was that the hazard ratio (HR) equals to 1 between SIM treatment arm and placebo, while the alternative hypothesis was that HR was less than 1.~The HR (95% confidence interval [CI]) and p-value (for comparison between SIM treatment arm and placebo) were based on two-sided log-rank test, stratified based on the 2-level Eastern Cooperative Oncology Group (ECOG) performance status (0 or > 0) at randomization."|
1664481|NCT01479127|3061983|Superiority or Other|||||||0.074|||||||Paired t-test||||
1664482|NCT01479127|3061988|Superiority or Other|||||||0.125|||||||Wilcoxon one-sample test||||
1664483|NCT01479127|3061989|Superiority or Other|||||||1|||||||Wilcoxon one-sample test|||"Off state staging"|
1664484|NCT01479127|3061989|Superiority or Other|||||||1|||||||Wilcoxon one-sample test|||"On state staging"|
1664485|NCT01479127|3061990|Superiority or Other|||||||0.576|||||||Paired t-test|||Domain: Bodily discomfort|
1664486|NCT01479127|3061990|Superiority or Other|||||||0.866|||||||Paired t-test|||Domain: Communication|
1664487|NCT01479127|3061990|Superiority or Other|||||||0.456|||||||Paired t-test|||Domain: Cognition|
1664488|NCT01479127|3061990|Superiority or Other|||||||0.178|||||||Paired t-test|||Domain: Social support|
1664489|NCT01479127|3061990|Superiority or Other|||||||0.799|||||||Paired t-test|||Domain: Stigma|
1664490|NCT01479127|3061990|Superiority or Other|||||||0.22|||||||Paired t-test|||Domain: Emotional well-being|
1664491|NCT01479127|3061990|Superiority or Other|||||||0.902|||||||Paired t-test|||Domain: Activities of daily living|
1664492|NCT01479127|3061990|Superiority or Other|||||||0.329|||||||Paired t-test|||Domain: Mobility|
1664493|NCT01479127|3061990|Superiority or Other|||||||0.636|||||||Paired t-test|||Total score|
1664494|NCT01479127|3061991|Superiority or Other|||||||0.108|||||||Paired t-test|||Part IV sub-score of dyskinesia|
1664495|NCT01479127|3061991|Superiority or Other|||||||0.53|||||||Paired t-test|||Part III|
1664496|NCT01479127|3061991|Superiority or Other|||||||0.493|||||||Paired t-test|||Part II (Off-time)|
1664497|NCT01479127|3061991|Superiority or Other|||||||0.799|||||||Paired t-test|||Part II|
1664498|NCT01479127|3061991|Superiority or Other|||||||0.374|||||||Paired t-test|||Part I|
1664499|NCT01479127|3061991|Superiority or Other|||||||0.87|||||||Paired t-test|||Total score|
1664500|NCT01479127|3061992|Superiority or Other|||||||0.25|||||||Wilcoxon one-sample test|||Dyskinesia|
1664501|NCT01479127|3061992|Superiority or Other|||||||0.5|||||||Wilcoxon one-sample test|||Body bradykinesia and hypokinesia|
1664502|NCT01479127|3061992|Superiority or Other|||||||0.25|||||||Wilcoxon one-sample test|||Postural stability|
1664503|NCT01479127|3061992|Superiority or Other|||||||1|||||||Wilcoxon one-sample test|||Arising from chair|
1664504|NCT01479127|3061992|Superiority or Other|||||||0.5|||||||Wilcoxon one-sample test|||Rapid alternating movement of hands|
1664505|NCT01479127|3061993|Superiority or Other|||||||0.574|||||||Paired t-test|||ON time w/o D + time with NTD + time w/ TD|
1664506|NCT01479127|3061993|Superiority or Other|||||||0.661|||||||Paired t-test|||ON time w/o D + time with NTD|
1664507|NCT01479127|3061993|Superiority or Other|||||||0.574|||||||Paired t-test||||
1664508|NCT01479127|3061994|Superiority or Other|||||||0.374|||||||Paired t-test|||"TRS II Dyskinesia state"|
1664509|NCT01479127|3061994|Superiority or Other|||||||0.14|||||||Paired t-test|||"TRS II OFF state"|
1664510|NCT01479127|3061994|Superiority or Other|||||||0.153|||||||Paired t-test|||"TRS II Normal state"|
1664511|NCT01479127|3061994|Superiority or Other|||||||1|||||||Paired t-test|||"TRS I Dyskinesia state"|
1664512|NCT01479127|3061994|Superiority or Other|||||||0.058|||||||Paired t-test|||"TRS I OFF state"|
1664513|NCT01478958|3062018|Superiority or Other||||||>|0.05||||||Effect of n-6 PUFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.|||
1664514|NCT01478958|3062018|Superiority or Other||||||>|0.05||||||Effect of MUFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.|||
1664515|NCT01478958|3062018|Superiority or Other||||||>|0.021||||||Effect of the SFA-rich diet relative to baseline.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI and age, gender and intervention diet were used as prognostic factors in the model.|||
1664516|NCT01478958|3062018|Superiority or Other||||||>|0.238||||||Overall diet effect. No post-hoc analyses required. Adjusted for multiple comparisons.|General Linear Model Univariate Analysis|Baseline values for %FMD, BMI, age, gender and intervention diet used as prognostic factors in model.||To detect a 2% inter-group difference in FMD (primary outcome) using a SD of 2.3, 90% power and 5% significance level, n=171 participants were required (n=57 per group), increasing to n=228 to include a 25% dropout rate.|
1664517|NCT01478594|3062045|Superiority or Other||Hazard Ratio (HR)|0.744|||||2-Sided|95.0|0.299|1.85|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664518|NCT01478594|3062045|Superiority or Other||Hazard Ratio (HR)|1.538|||||2-Sided|95.0|0.548|4.32|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664519|NCT01478594|3062046|Superiority or Other||Hazard Ratio (HR)|1.384|||||2-Sided|95.0|0.554|3.455|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664523|NCT01478594|3062048|Superiority or Other||Hazard Ratio (HR)|1.505|||||2-Sided|95.0|0.585|3.873|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664524|NCT01478594|3062048|Superiority or Other||Hazard Ratio (HR)|0.803|||||2-Sided|95.0|0.307|2.1|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664525|NCT01478594|3062049|Superiority or Other||Hazard Ratio (HR)|1.232|||||2-Sided|95.0|0.447|3.396|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664526|NCT01478594|3062049|Superiority or Other||Hazard Ratio (HR)|1.226|||||2-Sided|95.0|0.468|3.214|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664527|NCT01478594|3062050|Superiority or Other||Hazard Ratio (HR)|0.983|||||2-Sided|95.0|0.503|1.918|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664528|NCT01478594|3062050|Superiority or Other||Hazard Ratio (HR)|0.95|||||2-Sided|95.0|0.343|2.63|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664529|NCT01478594|3062051|Superiority or Other||Hazard Ratio (HR)|1.241|||||2-Sided|95.0|0.615|2.501|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664530|NCT01478594|3062051|Superiority or Other||Hazard Ratio (HR)|0.776|||||2-Sided|95.0|0.303|1.991|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664531|NCT01478594|3062052|Superiority or Other||Hazard Ratio (HR)|0.806|||||2-Sided|95.0|0.422|1.538|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664532|NCT01478594|3062052|Superiority or Other||Hazard Ratio (HR)|1.946|||||2-Sided|95.0|0.636|5.956|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664533|NCT01478594|3062053|Superiority or Other||Hazard Ratio (HR)|0.779|||||2-Sided|95.0|0.397|1.531|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664534|NCT01478594|3062053|Superiority or Other||Hazard Ratio (HR)|1.627|||||2-Sided|95.0|0.58|4.564|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664535|NCT01478594|3062054|Superiority or Other||Hazard Ratio (HR)|1.597|||||2-Sided|95.0|0.672|3.795|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664536|NCT01478594|3062054|Superiority or Other||Hazard Ratio (HR)|0.721|||||2-Sided|95.0|0.345|1.507|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664537|NCT01478594|3062055|Superiority or Other||Hazard Ratio (HR)|1.275|||||2-Sided|95.0|0.614|2.646|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664538|NCT01478594|3062055|Superiority or Other||Hazard Ratio (HR)|0.877|||||2-Sided|95.0|0.366|2.1|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664539|NCT01478594|3062056|Superiority or Other||Hazard Ratio (HR)|0.755|||||2-Sided|95.0|0.375|1.521|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664540|NCT01478594|3062056|Superiority or Other||Hazard Ratio (HR)|1.608|||||2-Sided|95.0|0.635|4.073|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664541|NCT01478594|3062057|Superiority or Other||Hazard Ratio (HR)|0.575|||||2-Sided|95.0|0.285|1.16|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664542|NCT01478594|3062057|Superiority or Other||Hazard Ratio (HR)|1.331|||||2-Sided|95.0|0.746|2.375|||||The hazard ratio was calculated using an unadjusted Cox proportional hazard model including treatment arms as the covariate. Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of Tivozanib arm.||
1664586|NCT01475721|3062308|Superiority or Other||Mean Difference (Final Values)|-0.263|||<|0.001|2-Sided|95.0|-0.385|-0.141|||Regression, Cox||Efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy||
1665212|NCT01462435|3064102|Superiority or Other|||||||0.004|||||||t-test, 2 sided||||
1664543|NCT01478594|3062060|Superiority or Other||Hazard Ratio (HR)|1.006||||0.967|2-Sided|95.0|0.746|1.358|||Log Rank|Stratification factors were LDH status (< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR < 1 indicates a reduction in the HR in favor of tivozanib.||
1664544|NCT01478594|3062061|Superiority or Other||Hazard Ratio (HR)|1.389||||0.437|2-Sided|95.0|0.604|3.194|||Log Rank|Stratification factors were LDH status (< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR < 1 indicates a reduction in the HR in favor of tivozanib.||
1664545|NCT01478594|3062062|Superiority or Other|||||||0.718|||||||Cochran-Mantel-Haenszel|Stratification factors were LDH status (< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|||
1664546|NCT01478594|3062063|Superiority or Other||Hazard Ratio (HR)|1.116||||0.754|2-Sided|95.0|0.561|2.218|||Log Rank|Stratification factors were LDH status (< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR < 1 indicates a reduction in the HR in favor of tivozanib.||
1664547|NCT01478594|3062065|Superiority or Other||Hazard Ratio (HR)|1.091||||0.706|2-Sided|95.0|0.693|1.718|||Log Rank|Stratification factors were LDH status (< 1.5 x ULN or ≥ 1.5 x ULN), origin of cancer (rectal or colon) and number of metastatic sites (1 or ≥ 2).|HR presented for the stratified analysis, which was based on the Cox proportional hazards model. Assuming proportional hazards, an HR < 1 indicates a reduction in the HR in favor of tivozanib.|An interim futility analysis was to be performed when approximately 83 PFS events (50% of the total PFS events) were observed. The Lans DeMets beta spending function with an O’Brien-Fleming boundary was used to derive the futility boundary. If the hazard ratio (HR) for PFS was greater than 1.0581, enrollment was to be stopped. With this futility stopping rule, the adjusted study power was 78.6%.|
1664548|NCT01478360|3062085|Superiority or Other||Mean Difference (Net)|-0.166||||0.5392|2-Sided|90.0|-0.617|0.285|||Mixed Models Analysis||||
1664549|NCT01478048|3062108|Superiority or Other||Difference using Chan-Zhang method|2.3|||||2-Sided|95.0|-13.2|17.8|||||||
1664550|NCT01478048|3062111|Superiority or Other||Hazard Ratio (HR)|0.72||||0.0923|2-Sided|95.0|0.49|1.06||Log Rank test was stratified by prior proteasome inhibitor use (Yes versus No), presence of at least 1 FcγRIIIa V allele (Yes versus No) and number of prior lines of therapy (1 versus 2 or 3) at randomization|Log Rank|Adjusted alpha level= 0.30|||
1664551|NCT01477710|3062136|Superiority or Other||Mean Difference (Final Values)|262.2|Standard Deviation|25.0|<|0.0001|2-Sided|95.0|212.5|312.0|||t-test, 2 sided||||
1664552|NCT01477710|3062136|Superiority or Other||Mean Difference (Final Values)|576.6|Standard Error of the Mean|25.0|<|0.0001|2-Sided|95.0|526.9|626.3|||t-test, 2 sided||||
1664553|NCT01477710|3062136|Superiority or Other||Mean Difference (Final Values)|314.4|||<|0.0001||95.0|264.7|364.1|||t-test, 2 sided||||
1664554|NCT01477710|3062136|Superiority or Other||ANOVA F-value|266.39|||<|0.0001||||||This p-value is for the omnibus F-test of between-treatment differences in tidal volume|ANOVA|The p-value for the omnibus F-test was <0.0001||Using ANOVA, pairwise comparisons of treatment means were made using a Tukey adjustment for multiple comparisons.|
1664555|NCT01477450|3062148|Superiority or Other|||||||1|||||||Chi-squared||||
1664556|NCT01477450|3062148|Superiority or Other|||||||0.47|||||||Chi-squared||||
1664557|NCT01477450|3062148|Superiority or Other|||||||0.3|||||||Chi-squared||||
1664558|NCT01476644|3062177|Superiority or Other (legacy)||||||<|0.01|||||||Regression, Linear||||
1664559|NCT01476475|3062187|Superiority or Other||LS Mean Difference|-3.24|Standard Error of the Mean|1.704||0.0583|2-Sided|95.0|-6.592|0.114||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (<8.0, ≥8.0%), randomization strata of screening BMI (<30 kg/m^2, ≥30 kg/m^2), and country as fixed effects.|
1664560|NCT01476475|3062188|Superiority or Other||LS Mean Difference|-1.44|Standard Error of the Mean|0.34|<|0.0001|2-Sided|95.0|-2.11|-0.773||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (<8.0, ≥8.0%), randomization strata of screening BMI (<30 kg/m^2, ≥30 kg/m^2), and country as fixed effects and baseline body weight value as covariates.|
1664561|NCT01476475|3062189|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.125||0.0154|2-Sided|95.0|-0.55|-0.058||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (<8.0, ≥8.0%), randomization strata of screening BMI (<30 kg/m^2, ≥30 kg/m^2), and country as fixed effects and baseline average 7-point SMPG value as covariates.|
1664562|NCT01476475|3062190|Superiority or Other||LS Mean Difference|-3.24|Standard Error of the Mean|0.331|<|0.0001|2-Sided|95.0|-3.895|-2.592||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Testing according to the step-down testing procedure (continued only if previous endpoint was statistically significant). Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (<8.0, ≥8.0%), randomization strata of screening BMI (<30 kg/m^2, ≥30 kg/m^2), and country as fixed effects and baseline 2-hour plasma glucose excursion value as covariates.|
1664587|NCT01475721|3062309|Superiority or Other||Hazard Ratio (HR)|0.776||||0.123|2-Sided|95.0|0.562|1.071|||Regression, Cox||||
1664588|NCT01475721|3062311|Superiority or Other||Hazard Ratio (HR)|0.687||||0.075|2-Sided|95.0|0.454|1.04|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.|
1664563|NCT01476475|3062191|Superiority or Other||LS Mean Difference|-3.17|Standard Error of the Mean|0.337|<|0.0001|2-Sided|95.0|-3.832|-2.504||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using ANCOVA with treatment groups,randomization strata of screening HbA1c(<8.0, ≥8.0%)& screening BMI(<30 kg/m^2, ≥30 kg/m^2),country as fixed effects and baseline 2-hour PPG value as covariates.A step-down testing procedure used to control type-1 error.If non-inferiority demonstrated for primary endpoint,superiority testing on secondary endpoints was performed sequentially in order endpoints are reported(continued only if previous endpoint was statistically significant).|
1664564|NCT01476475|3062192|Superiority or Other||LS Mean Difference|-0.17|Standard Error of the Mean|0.07||0.013|2-Sided|95.0|-0.312|-0.037||Threshold for significance at 0.05 level.|ANCOVA||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using ANCOVA model with treatment groups, randomization strata of screening HbA1c (<8.0, ≥8.0%), randomization strata of screening BMI (<30 kg/m^2, ≥30 kg/m^2), and country as fixed effects and baseline HbA1c value as covariates. If non-inferiority was established, then a test of superiority of insulin glargine/lixisenatide FRC over insulin glargine would be performed, at alpha level of 0.05 (2-sided).|
1664565|NCT01476475|3062192|Non-Inferiority or Equivalence|The non-inferiority of insulin glargine/lixisenatide FRC versus insulin glargine was tested first, at alpha level of 0.025 (1-sided) and a non-inferiority margin of 0.4% HbA1c. If non-inferiority was established, then a test of superiority of insulin glargine/lixisenatide FRC over insulin glargine would be performed, at alpha level of 0.05 (2-sided). The non-inferiority was assessed using upper bound of 2-sided 95% confidence interval (CI) at ≤0.4%.|Least square (LS) mean difference|-0.17|Standard Error of the Mean|0.07|||2-Sided|95.0|-0.312|-0.037|||||Insulin glargine/Lixisenatide FRC vs Insulin glargine|Analysis was performed using analysis of covariance (ANCOVA) model with treatment groups, randomization strata of screening HbA1c (<8.0, ≥8.0%), randomization strata of screening BMI (<30 kg/m^2, ≥30 kg/m^2), and country as fixed effects and baseline HbA1c value as covariates. A step-down testing procedure described by Hochberg and Tamhane was used to control type-1 error.|
1664566|NCT01475955|3062275|Superiority or Other|||||||0.0041|||||||Chi-squared|||Pearson chi-square|
1664567|NCT01475838|3062290|Non-Inferiority or Equivalence|The null hypothesis was that the Stribild group was at least 12% worse than the PI+RTV+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA < 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the PI+RTV+FTC/TDF group.|Difference in proportions|6.7||||0.025|2-Sided|95.0|0.4|13.7|||Fisher Exact||The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.||
1664568|NCT01475734|3062307|Superiority or Other||Ratio|1.0|||>|0.999|2-Sided|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 30 min.||
1664569|NCT01475734|3062307|Superiority or Other||Ratio|1.008|||>|0.759|2-Sided|95.0|0.96|1.058|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr 15 min.||
1664570|NCT01475734|3062307|Superiority or Other||Ratio|0.991|||>|0.715|2-Sided|95.0|0.944|1.04|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 5 hr.||
1664571|NCT01475734|3062307|Superiority or Other||Ratio|0.994|||>|0.821|2-Sided|95.0|0.947|1.044|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 45 min.||
1664572|NCT01475734|3062307|Superiority or Other||Ratio|0.975|||>|0.298|2-Sided|95.0|0.928|1.023|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 30 min.||
1664573|NCT01475734|3062307|Superiority or Other||Ratio|0.971|||>|0.238|2-Sided|95.0|0.925|1.02|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 4 hr 15 min.||
1664574|NCT01475734|3062307|Superiority or Other||Ratio|1.046|||>|0.07|2-Sided|95.0|0.996|1.098|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 45 min.||
1664575|NCT01475734|3062307|Superiority or Other||Ratio|1.095|||<|0.001|2-Sided|95.0|1.043|1.15|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr 30 min.||
1664576|NCT01475734|3062307|Superiority or Other||Ratio|1.008|||<|0.763|2-Sided|95.0|0.96|1.058|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 3 hr.||
1664577|NCT01475734|3062307|Superiority or Other||Ratio|1.025|||<|0.312|2-Sided|95.0|0.977|1.077|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr 45 min.||
1664578|NCT01475734|3062307|Superiority or Other||Ratio|1.003|||<|0.908|2-Sided|95.0|0.955|1.053|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 2 hr.||
1664579|NCT01475734|3062307|Superiority or Other||Ratio|1.0|||>|0.999|2-Sided|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 45 min.||
1664580|NCT01475734|3062307|Superiority or Other||Ratio|1.001|||>|0.975|2-Sided|95.0|0.953|1.051|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr 15 min.||
1664581|NCT01475734|3062307|Superiority or Other||Ratio|1.0|||>|0.999|2-Sided|95.0|0.952|1.05|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 1 hr.||
1664582|NCT01475734|3062307|Superiority or Other||Ratio|0.993|||>|0.791|2-Sided|95.0|0.946|1.043|||ANOVA||The estimated value represents the ratio of geometric least squares means (albiglutide 50 mg) to placebo at 0 hr.||
1664583|NCT01475721|3062308|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.251|2-Sided|95.0|-0.216|0.056|||Regression, Cox||Efficacy subgroup: Subjects controlled on prior ICS therapy||
1664584|NCT01475721|3062308|Superiority or Other||Mean Difference (Final Values)|-0.172|||<|0.001|2-Sided|95.0|-0.238|-0.106|||Regression, Cox||Efficacy subgroup: Subjects controlled on prior ICS+LABA therapy||
1664585|NCT01475721|3062308|Superiority or Other||Mean Difference (Final Values)|-0.222|||<|0.003|2-Sided|95.0|-0.369|-0.076|||Regression, Cox||Efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy||
1665213|NCT01462435|3064102|Superiority or Other|||||||0.004|||||||t-test, 2 sided||||
1664589|NCT01475721|3062311|Superiority or Other||Hazard Ratio (HR)|0.755||||0.001|2-Sided|95.0|0.637|0.895|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.|
1664590|NCT01475721|3062311|Superiority or Other||Hazard Ratio (HR)|0.864||||0.271|2-Sided|95.0|0.665|1.122|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.|
1664591|NCT01475721|3062311|Superiority or Other||Hazard Ratio (HR)|0.878||||0.373|2-Sided|95.0|0.659|1.17|||Regression, Cox||Analysis of number of asthma exacerbations in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.|
1664592|NCT01475721|3062311|Superiority or Other||Hazard Ratio (HR)|0.682||||0.071|2-Sided|95.0|0.451|1.034|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.|
1664593|NCT01475721|3062311|Superiority or Other||Hazard Ratio (HR)|0.764||||0.002|2-Sided|95.0|0.645|0.905|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.|
1664594|NCT01475721|3062311|Superiority or Other||Hazard Ratio (HR)|0.839||||0.188|2-Sided|95.0|0.645|1.09|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS+LABA therapy|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.|
1664595|NCT01475721|3062311|Superiority or Other||Hazard Ratio (HR)|0.834||||0.203|2-Sided|95.0|0.63|1.103|||Regression, Cox||Analysis of time to first exacerbation in efficacy subgroup: Subjects not well-controlled on prior ICS or non-LABA therapy.|The hazard ratio computed is essentially the relative risk of having the event in the treatment group relative to the control group, adjusted for time to the event.|
1664596|NCT01475721|3062312|Non-Inferiority or Equivalence|The non-inferiority comparison is statistically significant if the upper bound of the two-sided 95% CI falls below 2, the non-inferiority margin, and the non-inferiority test one-sided p-value <0.025.|Hazard Ratio (HR)|1.029||||0.003|2-Sided|95.0|0.638|1.662|||Regression, Cox||||
1664597|NCT01475487|3062331|Superiority or Other||Risk Ratio (RR)|5.6||||0.043|2-Sided|95.0|0.79|39.48|||Fisher Exact|||Comparison for Grade 3-4|
1664598|NCT01475487|3062332|Superiority or Other||Risk Ratio (RR)|0.91||||0.701|2-Sided|95.0|0.12|2.72|||Fisher Exact||This is the risk ratio for 1 vs 2 attempts||
1664599|NCT01475487|3062333|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Grade 3-4 comparison of None-mild and moderate-severe|
1664600|NCT01475487|3062333|Superiority or Other||Risk Ratio (RR)|2.88|||<|0.001|2-Sided|95.0|1.39|5.94|||Fisher Exact||Risk of injury ( none-mild vs moderate -severe) for all participants||
1664601|NCT01475487|3062334|Non-Inferiority or Equivalence|A sample size of 21 participants per group was required to detect a 40% absolute difference in the complication rate between DP and US guided techniques assuming a 45% complication rate in the DP (control) group and using the Fisher's exact test for the comparison of independent proportions. A total of 23 and 24 participants were recruited in the DP and US group, respectively.|||||<|0.01|||||||Fisher Exact||||
1664602|NCT01475474|3062335|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed-Rank Test|||Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in Wexner score|
1664603|NCT01475474|3062336|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed-Rank Test|||Wilcoxon Signed-Rank Test used to evaluate median Percent Change-from-Baseline in ABL different from zero|
1664604|NCT01475461|3062338|Superiority or Other||LS Mean difference|-0.49|Standard Error of the Mean|0.545||0.3702|2-Sided|80.0|-1.19|0.21||P-value was 2-sided.|t-test, 2 sided|||Week 14 (Follow-up): Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664605|NCT01475461|3062338|Superiority or Other||LS Mean Difference|-0.22|Standard Error of the Mean|0.55||0.6921|2-Sided|80.0|-0.92|0.49||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664606|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.22|Standard Error of the Mean|0.545||0.681|2-Sided|80.0|-0.48|0.92||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664607|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.21|Standard Error of the Mean|0.563||0.7137|2-Sided|80.0|-0.52|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664608|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.7|Standard Error of the Mean|0.545||0.2031|2-Sided|80.0|0.0|1.4||P-value was 2-sided.|t-test, 2 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664609|NCT01475461|3062338|Superiority or Other||LS Mean Difference|-0.08|Standard Error of the Mean|0.512||0.8694|2-Sided|80.0|-0.74|0.57||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664712|NCT01474538|3062505|Superiority or Other||LS Mean Ratio|0.94||||0.522|||||||Negative binomial||||
1664610|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.23|Standard Error of the Mean|0.516||0.6631|2-Sided|80.0|-0.44|0.89||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664611|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.51|Standard Error of the Mean|0.511||0.315|2-Sided|80.0|-0.14|1.17||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664612|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.44|Standard Error of the Mean|0.527||0.4083|2-Sided|80.0|-0.24|1.11||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664613|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.69|Standard Error of the Mean|0.512||0.1757|2-Sided|80.0|0.04|1.35||P-value was 2-sided.|t-test, 2 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664614|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.06|Standard Error of the Mean|0.489||0.907|2-Sided|80.0|-0.57|0.68||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664615|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.31|Standard Error of the Mean|0.492||0.5331|2-Sided|80.0|-0.32|0.94||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664616|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.53|Standard Error of the Mean|0.487||0.2782|2-Sided|80.0|-0.1|1.15||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664617|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.31|Standard Error of the Mean|0.502||0.5341|2-Sided|80.0|-0.33|0.96||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664618|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.79|Standard Error of the Mean|0.488||0.1054|2-Sided|80.0|0.17|1.42||P-value was 2-sided.|t-test, 2 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664619|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.32|Standard Error of the Mean|0.479||0.5107|2-Sided|80.0|-0.3|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664620|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.31|Standard Error of the Mean|0.481||0.5191|2-Sided|80.0|-0.31|0.93||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664621|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.48|Standard Error of the Mean|0.476||0.3165|2-Sided|80.0|-0.13|1.09||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664622|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.51|Standard Error of the Mean|0.49||0.3012|2-Sided|80.0|-0.12|1.14||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664623|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.91|Standard Error of the Mean|0.478||0.0577|2-Sided|80.0|0.3|1.52||P-value was 2-sided.|t-test, 2 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664624|NCT01475461|3062338|Superiority or Other||LS Mean Difference|-0.06|Standard Error of the Mean|0.449||0.8947|2-Sided|80.0|-0.64|0.52||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664625|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.452||0.5066|2-Sided|80.0|-0.28|0.88||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664626|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.04|Standard Error of the Mean|0.447||0.9244|2-Sided|80.0|-0.53|0.62||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664627|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.29|Standard Error of the Mean|0.461||0.5236|2-Sided|80.0|-0.3|0.89||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664628|NCT01475461|3062338|Superiority or Other||LS Mean Difference|0.76|Standard Error of the Mean|0.449||0.0913|2-Sided|80.0|0.18|1.34||P-value was 2-sided.|t-test, 2 sided|||Week 2: Treatment difference and 80 percent (%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664629|NCT01475461|3062345|Superiority or Other||LS Mean Difference|1.66|Standard Error of the Mean|6.487||0.601|2-Sided|80.0|-6.67|10.0||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664630|NCT01475461|3062345|Superiority or Other||LS Mean Difference|15.98|Standard Error of the Mean|6.527||0.9925|2-Sided|80.0|7.59|24.36||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664631|NCT01475461|3062345|Superiority or Other||LS Mean Difference|6.17|Standard Error of the Mean|6.496||0.8285|2-Sided|80.0|-2.17|14.52||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664632|NCT01475461|3062345|Superiority or Other||LS Mean Difference|2.68|Standard Error of the Mean|6.676||0.656|2-Sided|80.0|-5.89|11.26||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664633|NCT01475461|3062345|Superiority or Other||LS Mean Difference|0.22|Standard Error of the Mean|6.476||0.5132|2-Sided|80.0|-8.1|8.53||p-value was 1-sided.|t-test, 1 sided|||Week 14: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664634|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-8.76|Standard Error of the Mean|6.398||0.086|2-Sided|80.0|-16.98|-0.54||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664635|NCT01475461|3062345|Superiority or Other||LS Mean Difference|9.06|Standard Error of the Mean|6.441||0.9197|2-Sided|80.0|0.79|17.34||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664636|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-4.1|Standard Error of the Mean|6.411||0.2616|2-Sided|80.0|-12.33|4.14||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664637|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-0.06|Standard Error of the Mean|6.578||0.4961|2-Sided|80.0|-8.51|8.38||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664638|NCT01475461|3062345|Superiority or Other||LS Mean Difference|1.17|Standard Error of the Mean|6.387||0.5727|2-Sided|80.0|-7.03|9.37||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664639|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-15.41|Standard Error of the Mean|5.649||0.0034|2-Sided|80.0|-22.67|-8.16||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664640|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-4.41|Standard Error of the Mean|5.663||0.2185|2-Sided|80.0|-11.68|2.87||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664641|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-12.12|Standard Error of the Mean|5.636||0.0161|2-Sided|80.0|-19.36|-4.88||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664642|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-2.07|Standard Error of the Mean|5.785||0.3604|2-Sided|80.0|-9.5|5.36||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664643|NCT01475461|3062345|Superiority or Other||LS Mean Difference|1.11|Standard Error of the Mean|5.599||0.5783|2-Sided|80.0|-6.08|8.3||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664644|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-19.9|Standard Error of the Mean|5.191||0.0001|2-Sided|80.0|-26.57|-13.23||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664713|NCT01474538|3062506|Superiority or Other||LS Mean difference|-0.28|||||2-Sided|95.0|-2.92|2.35|||||||
1664714|NCT01474538|3062507|Non-Inferiority or Equivalence|If the upper limit of the 95% confidence interval (CI) was below 0.4%, lispro was declared non-inferior to aspart.|LS Mean difference|0.1|||||2-Sided|95.0|-0.002|0.21|||||||
1664645|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-8.79|Standard Error of the Mean|5.171||0.0451|2-Sided|80.0|-15.43|-2.15||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664646|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-7.35|Standard Error of the Mean|5.147||0.077|2-Sided|80.0|-13.96|-0.74||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664647|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-1.88|Standard Error of the Mean|5.261||0.3604|2-Sided|80.0|-8.64|4.87||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664648|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-1.13|Standard Error of the Mean|5.138||0.4127|2-Sided|80.0|-7.73|5.47||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664649|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-11.22|Standard Error of the Mean|4.843||0.0106|2-Sided|80.0|-17.44|-5.0||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664650|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-7.28|Standard Error of the Mean|4.851||0.0673|2-Sided|80.0|-13.51|-1.05||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664651|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-3.24|Standard Error of the Mean|4.816||0.2511|2-Sided|80.0|-9.42|2.95||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664652|NCT01475461|3062345|Superiority or Other||LS Mean Difference|-1.77|Standard Error of the Mean|4.952||0.3608|2-Sided|80.0|-8.13|4.59||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664653|NCT01475461|3062345|Superiority or Other||LS Mean Difference|2.87|Standard Error of the Mean|4.823||0.724|2-Sided|80.0|-3.32|9.07||p-value was 1-sided.|t-test, 1 sided|||Week 2: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664654|NCT01475461|3062346|Superiority or Other||LS Mean Difference|-0.42|Standard Error of the Mean|0.146||0.0021|2-Sided|80.0|-0.61|-0.23||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664655|NCT01475461|3062346|Superiority or Other||LS Mean Difference|-0.54|Standard Error of the Mean|0.146||0.0001|2-Sided|80.0|-0.73|-0.35||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.|
1664656|NCT01475461|3062346|Superiority or Other||LS Mean Difference|-0.12|Standard Error of the Mean|0.145||0.212|2-Sided|80.0|-0.3|0.07||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664657|NCT01475461|3062346|Superiority or Other||LS Mean Difference|-0.13|Standard Error of the Mean|0.15||0.1873|2-Sided|80.0|-0.33|0.06||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664658|NCT01475461|3062346|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.144||0.5133|2-Sided|80.0|-0.18|0.19||p-value was 1-sided.|t-test, 1 sided|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664659|NCT01475461|3062346|Superiority or Other||LS Mean Difference|-0.33|Standard Error of the Mean|0.098||0.0005|2-Sided|80.0|-0.45|-0.2||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664660|NCT01475461|3062346|Superiority or Other||LS Mean Difference|-0.27|Standard Error of the Mean|0.098||0.0031|2-Sided|80.0|-0.4|-0.15||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.|
1664661|NCT01475461|3062346|Superiority or Other||LS Mean Difference|-0.14|Standard Error of the Mean|0.097||0.0826|2-Sided|80.0|-0.26|-0.01||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.|
1664662|NCT01475461|3062346|Superiority or Other||LS Mean Difference|-0.14|Standard Error of the Mean|0.101||0.0892|2-Sided|80.0|-0.27|-0.01||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, as the covariates, time was repeated for participant.|
1664663|NCT01475461|3062346|Superiority or Other||LS Mean Difference|-0.04|Standard Error of the Mean|0.097||0.3434|2-Sided|80.0|-0.16|0.09||p-value was 1-sided.|t-test, 1 sided|||Week 4: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1664664|NCT01475461|3062347|Superiority or Other||LS Mean Difference|-0.43|Standard Error of the Mean|0.173||0.0068|2-Sided|80.0|-0.65|-0.21||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.|
1664665|NCT01475461|3062347|Superiority or Other||LS Mean Difference|-0.45|Standard Error of the Mean|0.174||0.0049|2-Sided|80.0|-0.68|-0.23||p-value was 1-sided.|t-test, 1 sided|||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.|
1664666|NCT01475461|3062347|Superiority or Other||LS Mean Difference|-0.17|Standard Error of the Mean|0.172||0.1592|2-Sided|80.0|-0.39|0.05||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.|
1664667|NCT01475461|3062347|Superiority or Other||LS Mean Difference|-0.17|Standard Error of the Mean|0.178||0.1645|2-Sided|80.0|-0.4|0.05||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo|
1664668|NCT01475461|3062347|Superiority or Other||Least squares (LS) Mean Difference|0.01|Standard Error of the Mean|0.172||0.5206|2-Sided|80.0|-0.21|0.23||p-value was 1-sided.|t-test, 1 sided|No adjustments were made for multiple comparisons among treatment groups.||Week 12: Treatment difference and 80 percent(%) confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant. Null hypothesis stated there was no difference between PF 04937319 and placebo, alternative hypothesis stated PF 04937319 was superior to placebo.|
1664669|NCT01475305|3062371|Superiority or Other||Relative Risk|1.0|||||2-Sided|95.0|0.16|6.24|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by Any Method|
1664670|NCT01475305|3062371|Superiority or Other||Relative Risk|0.0|||||2-Sided|95.0|0.0|2.05|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by DFA|
1664671|NCT01475305|3062371|Superiority or Other||Relative Risk|1.0|||||2-Sided|95.0|0.16|6.24|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.|RSV infection by quantitative real-time RT-PCR|
1664672|NCT01475305|3062372|Superiority or Other||Relative Risk|0.0|||||2-Sided|95.0|0.0|2.05|||||Relative risk was calculated as the proportion of participants with RSV infection in the MEDI-557 arm divided by the proportion of participants with RSV infection in the placebo arm.||
1664673|NCT01475071|3062404|Superiority or Other||Mean Difference (Final Values)|-4.9|Standard Deviation|2.7|<|0.001|2-Sided||||||Wilcoxon (Mann-Whitney)|two-sided Wilcoxon rank signed||superiority of Metvix adaylight and Metvix Lamp in term of pain|
1664674|NCT01475071|3062405|Non-Inferiority or Equivalence|Non inferiority margin of -10%|Mean Difference (Final Values)|-3.5|Standard Deviation|15.6||0.0345|1-Sided|95.0|-6.8||||paired Student's t statistic|||The primary purpose of this study is to demonstrate the non-inferiority of Metvix and daylight compared to Metvix and the lamp in terms of lesion complete response rate.|
1664675|NCT01474876|3062424|Superiority or Other|||||||0.5|||||||Regression, Logistic|||Remission and BASDAI at Visit 0|
1664676|NCT01474876|3062424|Superiority or Other|||||||0.0733|||||||Regression, Logistic|||Remission and Psoriasis at Visit 0|
1664677|NCT01474876|3062424|Superiority or Other|||||||0.1739|||||||Regression, Logistic|||Treatment response and BASDAI score at Visit 0|
1664678|NCT01474876|3062424|Superiority or Other|||||||0.0576|||||||Regression, Logistic|||Treatment response and presence of enthesitis at Visit 0|
1664679|NCT01474876|3062433|Superiority or Other|||||||0.503|||||||Regression, Logistic|||Remission and BASDAI score at Visit 0|
1664680|NCT01474876|3062433|Superiority or Other|||||||0.0438|||||||Regression, Logistic|||Remission and male gender|
1664681|NCT01474876|3062433|Superiority or Other|||||||0.0734|||||||Regression, Logistic|||Remission and positive tuberculosis screening at Visit 0|
1664682|NCT01474876|3062433|Superiority or Other|||||||0.0001|||||||Regression, Logistic|||Remission and participant age|
1664683|NCT01474876|3062433|Superiority or Other|||||||0.0867|||||||Regression, Logistic|||Treatment response and BASDAI score at Visit 0|
1664684|NCT01474876|3062433|Superiority or Other|||||||0.02|||||||Regression, Logistic|||Treatment response and presence of enthesitis at Visit 0|
1664685|NCT01474876|3062433|Superiority or Other|||||||0.0164|||||||Regression, Logistic|||Treatment response and participant age|
1664686|NCT01474863|3062440|Superiority|||||||0.86|||||||ANOVA||||
1664715|NCT01474512|3062510|Superiority or Other (legacy)||||||<|0.001||||||P-value if for PPASI100.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664687|NCT01474772|3062441|Superiority or Other||Mean Difference (Final Values)|0.009|Standard Error of the Mean|0.02||0.53965|2-Sided|95.0|-0.021|0.039||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Statistical analysis presented above is for the Index score Dolan 2001. Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664688|NCT01474772|3062441|Superiority or Other||Mean Difference (Final Values)|0.006|Standard Error of the Mean|0.02||0.71107|2-Sided|95.0|-0.025|0.037||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Statistical analysis presented above is for the Index score Dolan 1997. Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664689|NCT01474772|3062442|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.18||0.199|2-Sided|95.0|-0.6|0.13||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664690|NCT01474772|3062443|Superiority or Other||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.18||0.1178|2-Sided|95.0|-0.63|0.07||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664691|NCT01474772|3062444|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.15||0.0105|2-Sided|95.0|-0.68|-0.09||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.|
1664692|NCT01474772|3062445|Superiority or Other||Odds Ratio (OR)|2.54||||0.002|2-Sided|95.0|1.3|4.95|||Cochran-Mantel-Haenszel|||Odds ratio is based on the binary response for any improvement while p-value is from the comparison of the original scale of 7 possible outcomes. P-value was calculated by using Cochran Mantel-Haenszel (CMH) test. PGIC values at the end of Period 1 data was compared between treatment groups.|
1664693|NCT01474772|3062446|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.1||0.9686|2-Sided|95.0|-0.21|0.2||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664694|NCT01474772|3062447|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.19||0.1985|2-Sided|95.0|-0.13|0.62||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664695|NCT01474772|3062448|Superiority or Other||Mean Difference (Final Values)|-1.27|Standard Error of the Mean|0.68||0.0634|2-Sided|95.0|-2.62|0.07||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664696|NCT01474772|3062449|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.18||0.7542|2-Sided|95.0|-0.41|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664697|NCT01474772|3062450|Superiority or Other||Mean Difference (Final Values)|-0.34|Standard Error of the Mean|0.33||0.3028|2-Sided|95.0|-0.99|0.31||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664698|NCT01474772|3062451|Superiority or Other||Mean Difference (Final Values)|-1.46|Standard Error of the Mean|1.09||0.1805|2-Sided|95.0|-3.6|0.68||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664716|NCT01474512|3062510|Superiority or Other (legacy)||||||<|0.001||||||P-value is for PPASI100|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664699|NCT01474772|3062452|Superiority or Other||Mean Difference (Final Values)|-1.37|Standard Error of the Mean|1.27||0.2854|2-Sided|95.0|-3.88|1.15||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664700|NCT01474772|3062453|Superiority or Other||Mean Difference (Final Values)|-2.63|Standard Error of the Mean|206.37||0.9899|2-Sided|95.0|-411.26|406.01||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.|
1664701|NCT01474772|3062454|Superiority or Other||Mean Difference (Final Values)|563.39|Standard Error of the Mean|4098.74||0.8909|2-Sided|95.0|-7549.82|8676.6||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline value, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. LOCF approach was applied.|
1664702|NCT01474772|3062455|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.17||0.2719|2-Sided|95.0|-0.53|0.15||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664703|NCT01474772|3062456|Superiority or Other||Mean Difference (Final Values)|-1.16|Standard Error of the Mean|0.86||0.1781|2-Sided|95.0|-2.86|0.53||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664704|NCT01474772|3062457|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.46||0.0889|2-Sided|95.0|-1.71|0.12||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1664705|NCT01474772|3062458|Superiority or Other||Odds Ratio (OR)|1.38||||0.2459|2-Sided|95.0|0.8|2.39||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Generalized linear mixed model|||Analysis was done overall (period 1 and period 2) using a generalized linear mixed model which included response as the dependent variable, sequence, period, pooled center, treatment as fixed effects, and subject within treatment as random effect. LOCF approach was applied.|
1664706|NCT01474772|3062459|Superiority or Other||Odds Ratio (OR)|1.55||||0.0847|2-Sided|95.0|0.94|2.55||Secondary analysis was two-sided and performed at the 0.05 significance level. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Generalized linear mixed model|||Analysis was done overall (period 1 and period 2) using a generalized linear mixed model which included response as the dependent variable, sequence, period, pooled center, treatment as fixed effects, and subject within treatment as random effect. LOCF approach was applied.|
1664707|NCT01474772|3062460|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.16||0.412|2-Sided|95.0|-0.44|0.18||Primary analysis was two-sided and performed at the 0.05 significance level. The study was considered positive only if both co-primary endpoints have p-values that are less than 0.05, hence there was no need for multiplicity adjustment.|Mixed-Effect Model Repeated Measures|Satterthwaite’s approximation was used to estimate denominator degrees of freedom.||Analysis was done using a repeated measure linear mixed effects model including baseline pain, sequence, period, center, time, treatment, and treatment by time interaction as fixed effect factors and participant within sequence and within-participant error as random factors. The model term ‘time’ may take 2 values corresponding to Week 3 and Week 6 in each period.|
1664708|NCT01474772|3062461|Superiority or Other||Mean Difference (Final Values)|-0.291|Standard Error of the Mean|0.128||0.0242|2-Sided|95.0|-0.543|-0.038||Primary analysis was two-sided and performed at the 0.05 significance level. Unstructured covariance structure was used to estimate the within-participant errors.|Repeated measure mixed effects model|The Kenward-Roger method was used to estimate denominator degrees of freedom.||This longitudinal analysis was a sensitivity analysis of the primary endpoint. P-value was based on a repeated measure mixed effects model including pooled center, time point, treatment, an indicator variable for Week 6 as well as interaction terms as fixed effect factors. For analysis purpose, it is assumed that participants were on placebo at Baseline, took the same treatment as in Period 1 during Week 1 of washout, and were on placebo in Week 2 of washout.|
1664709|NCT01474772|3062462|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.12||0.0659|2-Sided|95.0|-0.46|0.01||Primary analysis was two-sided and performed at the 0.05 significance level. The study was considered positive only if both co-primary endpoints had p-values that were less than 0.05, hence there was no need for multiplicity adjustment.|Linear mixed effects model|||Analysis was done using a linear mixed effects model including baseline pain, sequence, period, center, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. Last observation carried forward (LOCF) approach was applied.|
1664710|NCT01474538|3062503|Superiority or Other|||||||0.471|||||||Prescott test||||
1664711|NCT01474538|3062504|Superiority or Other||LS Mean difference|-0.58||||0.216|||||||Grizzle Model||||
1664719|NCT01474512|3062510|Superiority or Other (legacy)||||||<|0.001||||||P-value is for PPASI50.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664720|NCT01474512|3062510|Superiority or Other (legacy)||||||<|0.001||||||P-value is for PPASI50.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664721|NCT01474512|3062511|Superiority or Other (legacy)||||||<|0.001||||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis||||
1664722|NCT01474512|3062511|Superiority or Other (legacy)||||||<|0.001||||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis||||
1664723|NCT01474512|3062512|Superiority or Other (legacy)||||||<|0.001||||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for MCS.|||
1664724|NCT01474512|3062512|Superiority or Other (legacy)||||||<|0.001||||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for MCS.|||
1664725|NCT01474512|3062512|Superiority or Other (legacy)||||||<|0.001||||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for PCS.|||
1664726|NCT01474512|3062512|Superiority or Other (legacy)||||||<|0.001||||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline SF-36 value in the model.|ANCOVA|P-value is for PCS.|||
1664727|NCT01474512|3062513|Superiority or Other (legacy)||||||<|0.001||||||LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.|ANCOVA||||
1664728|NCT01474512|3062513|Superiority or Other (legacy)||||||<|0.001||||||LS Mean and p-values were calculated using an ANCOVA model that included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline QIDS value in the model.|ANCOVA||||
1664729|NCT01474512|3062514|Superiority or Other (legacy)||||||<|0.001||||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for work productively loss.|||
1664730|NCT01474512|3062514|Superiority or Other (legacy)||||||<|0.001||||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for work productively loss.|||
1664731|NCT01474512|3062514|Superiority or Other (legacy)||||||<|0.001||||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for presenteeism.|||
1664732|NCT01474512|3062514|Superiority or Other (legacy)||||||<|0.001||||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for presenteeism.|||
1664733|NCT01474512|3062514|Superiority or Other (legacy)||||||<|0.001||||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for activity impairment.|||
1664734|NCT01474512|3062514|Superiority or Other (legacy)||||||<|0.001||||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for activity impairment.|||
1664735|NCT01474512|3062514|Superiority or Other (legacy)||||||<|0.003||||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for absenteeism.|||
1664736|NCT01474512|3062514|Superiority or Other (legacy)||||||<|0.001||||||The LS Mean and p-values were calculated using an ANCOVA model and included treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, and baseline WPAI value.|ANCOVA|P-value is for Absenteeism.|||
1664737|NCT01474512|3062515|Superiority or Other (legacy)||||||<|0.001||||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis||||
1664738|NCT01474512|3062515|Superiority or Other (legacy)||||||<|0.001||||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis||||
1664739|NCT01474512|3062516|Superiority or Other (legacy)||||||<|0.001||||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis||||
1664740|NCT01474512|3062516|Superiority or Other (legacy)||||||<|0.001||||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis||||
1664741|NCT01474512|3062517|Superiority or Other (legacy)||||||<|0.001||||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis||||
1664742|NCT01474512|3062517|Superiority or Other (legacy)||||||<|0.001||||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis||||
1664743|NCT01474512|3062518|Superiority or Other (legacy)||||||<|0.001||||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis||||
1664744|NCT01474512|3062518|Superiority or Other (legacy)||||||<|0.001||||||LS mean and P-value were calculated using MMRM with baseline score as a covariate, treatment, geographic region, previous non-biologic systemic therapy, baseline weight category, visit and treatment-by-visit interaction as fixed effects.|Mixed Models Analysis||||
1664745|NCT01474512|3062519|Superiority or Other (legacy)||||||<|0.001|||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664746|NCT01474512|3062519|Superiority or Other (legacy)||||||<|0.001|||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664747|NCT01474512|3062520|Superiority or Other (legacy)||||||<|0.001|||||||Regression, Logistic|Logistic Regression analysis included treatment and baseline weight category as factors.|||
1664748|NCT01474512|3062520|Superiority or Other (legacy)||||||<|0.001|||||||Regression, Logistic|Logistic Regression analysis included treatment and baseline weight category as factors.|||
1664749|NCT01474512|3062521|Superiority or Other (legacy)||||||<|0.001||||||P-value is for PASI100.|Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.|||
1664750|NCT01474512|3062521|Superiority or Other (legacy)||||||<|0.001||||||P-value is for PASI100.|Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable; therefore the p-value is from Fisher's exact test.|||
1664751|NCT01474512|3062521|Superiority or Other (legacy)||||||<|0.001||||||P-value is for PASI90.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664752|NCT01474512|3062521|Superiority or Other (legacy)||||||<|0.001||||||P-value is for PASI90.|Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664753|NCT01474512|3062522|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.|||
1664754|NCT01474512|3062522|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact|Due to the zero count in placebo group, p-values from Logistic Regression were not obtainable, therefore the p-value is from Fisher's exact test.|||
1664755|NCT01474512|3062523|Superiority or Other (legacy)||||||<|0.001|||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664756|NCT01474512|3062523|Superiority or Other (legacy)||||||<|0.001|||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664757|NCT01474512|3062524|Superiority or Other (legacy)||||||<|0.001|||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664758|NCT01474512|3062524|Superiority or Other (legacy)||||||<|0.001|||||||Regression, Logistic|Logistic Regression analysis included treatment, geographic region, previous non-biologic systemic therapy and baseline weight category as factors.|||
1664759|NCT01474291|3062564|Superiority or Other||Odds Ratio (OR)|1.22||||0.0076|2-Sided|95.0|1.05|1.41|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor Higher Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) (unit=1) on physician decision to initiate tocilizumab monotherapy; DAS28-ESR was calculated from the number of swollen joints and tender joints using 28-joint count, ESR (millimeters per hour [mm/hour]) and patient’s global assessment of disease activity; scores range from 0 to 10; higher scores correspond to greater disease activity (multivariate analysis)."|
1664760|NCT01474291|3062564|Superiority or Other||Odds Ratio (OR)|2.03||||0.0212|2-Sided|95.0|1.11|3.7|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor Past history of severe infectious disease upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."|
1664761|NCT01474291|3062564|Superiority or Other||Odds Ratio (OR)|5.74|||<|0.0001|2-Sided|95.0|3.92|8.43|||Wald Chi-square|Wald Chi-square Test for Type 3 GEE Analysis.||"Influence of baseline factor No methotrexate (MTX) sequences within the two last years upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."|
1664762|NCT01474291|3062564|Superiority or Other||Odds Ratio (OR)|1.56|||<|0.023|2-Sided|95.0|1.06|2.3|||Wald Chi-square|Wald Chi-square Test for Type 3 generalized estimating equation (GEE) Analysis.||"Influence of baseline factor Patient's Age (>=65) upon physician's decision to initiate tocilizumab monotherapy (multivariate analysis)."|
1664763|NCT01474239|3062580|Superiority or Other|||||||0.4291||||||Statistical significance was assessed with a one-sided alpha error of 10 percent (%).|Exact Binomial Test|||The 6-month OS rate (OS-6) for bevacizumab was compared to the expected proportion of 0.60 under null hypothesis (ineffective treatment) with the application of the exact binomial test. The one-tailed statistical hypotheses was p0 less than or equal to (≤) 0.60 (null hypothesis) versus pA greater than or equal to (≥) 0.77 (alternative hypothesis), where p is the estimated probability of survival at 6 months.|
1664764|NCT01474122|3062613|Superiority or Other||Mean Difference (Net)|-0.2||||0.221|2-Sided|95.0|-0.4|0.1|||ANCOVA||||
1664765|NCT01474122|3062613|Superiority or Other||Mean Difference (Net)|-0.1||||0.319|2-Sided|95.0|-0.4|0.1|||ANCOVA||||
1664766|NCT01474122|3062614|Superiority or Other||Mean Difference (Net)|-0.1||||0.312|2-Sided|95.0|-0.2|0.1|||ANCOVA||||
1664767|NCT01474122|3062614|Superiority or Other||Mean Difference (Net)|-0.1||||0.339|2-Sided|95.0|-0.2|0.1|||ANCOVA||||
1664773|NCT01474122|3062617|Superiority or Other||Odds Ratio (OR)|0.831||||0.5668|2-Sided|95.0|0.442|1.564|||Chi-squared||||
1664774|NCT01474122|3062618|Superiority or Other||NB-2 estimate of new DUs per patient|1.208||||0.407|2-Sided|95.0|0.773|1.886|||NB-2||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in macitentan 10 mg and in placebo||
1664775|NCT01474122|3062618|Superiority or Other||NB-2 estimate of new DUs per patient|1.194||||0.434|2-Sided|95.0|0.766|1.861|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in macitentan 3 mg and in placebo||
1664776|NCT01474109|3062619|Superiority or Other||Mean Difference (Net)|-0.1||||0.342|2-Sided|95.0|-0.3|0.1|||ANCOVA||||
1664777|NCT01474109|3062619|Superiority or Other||Mean Difference (Net)|-0.1||||0.464|2-Sided|95.0|-0.3|0.1|||ANCOVA||||
1664778|NCT01474109|3062620|Superiority or Other||Mean Difference (Net)|-0.1||||0.44|2-Sided|95.0|-0.2|0.1|||ANCOVA||||
1664779|NCT01474109|3062620|Superiority or Other||Mean Difference (Net)|-0.1||||0.456|2-Sided|95.0|-0.2|0.1|||ANCOVA||||
1664780|NCT01474109|3062621|Superiority or Other||Mean Difference (Net)|0.0||||0.649|2-Sided|95.0|-0.2|0.1|||ANCOVA||||
1664781|NCT01474109|3062621|Superiority or Other||Mean Difference (Net)|0.0||||0.863|2-Sided|95.0|-0.1|0.2|||ANCOVA||||
1664782|NCT01474109|3062622|Superiority or Other||Odds Ratio (OR)|1.03||||0.9362|2-Sided|95.0|0.498|2.133|||Chi-squared||||
1664783|NCT01474109|3062622|Superiority or Other||Odds Ratio (OR)|0.696||||0.3625|2-Sided|95.0|0.319|1.518|||Chi-squared||||
1664784|NCT01474109|3062623|Superiority or Other||Odds Ratio (OR)|0.832||||0.5518|2-Sided|95.0|0.454|1.524|||Chi-squared||||
1664785|NCT01474109|3062623|Superiority or Other||Odds Ratio (OR)|0.875||||0.667|2-Sided|95.0|0.477|1.606|||Chi-squared||||
1664786|NCT01474109|3062624|Superiority or Other||NB-2 estimate of new DUs per patient|1.268||||0.36|2-Sided|95.0|0.763|2.106|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in Macitentan 10 mg and in Placebo||
1664787|NCT01474109|3062624|Superiority or Other||NB-2 estimate of new DUs per patient|1.103||||0.706|2-Sided|95.0|0.663|1.834|||negative binomial-2 regression (NB-2)||The estimated value corresponds to the treatment effect i.e. the ratio between the estimated number of new DUs in Macitentan 3 mg and in Placebo||
1664788|NCT01474018|3062625|Superiority or Other (legacy)|||||||0.009|||||||ANOVA||||
1664789|NCT01474018|3062625|Superiority or Other (legacy)|||||||0.01|||||||ANOVA||||
1664790|NCT01474018|3062626|Superiority or Other (legacy)|||||||0.004|||||||ANOVA||||
1664791|NCT01473940|3062644|Other|||||||||||||||||A 3 + 3 enrollment design was adopted to monitor safety and determine the MTD based on DLTs obsesved. The MTD is the highest dose at which 0 of 3 or 1 of 6 DLTs are detected. The MTD is exceeded if 2 of 3 or 2 of 6 DLTs are detected. There will be no dose escalation within a cohort.|The number of DLTs seen at each cohort were used to determine the MTD for the expansion cohort. The MTD was determined to be Gemcitabine - 1,000 mg/m2, Ipilimumab 3 mg/kg
1664792|NCT01473758|3062707|Superiority or Other||LS Mean Difference|-0.412|Standard Error of the Mean|2.687||0.8786|2-Sided|95.0|-5.766|4.943||The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.|ANCOVA||||
1664793|NCT01473758|3062708|Superiority or Other||LS Mean Difference|1.404|Standard Error of the Mean|3.07||0.6491|2-Sided|95.0|-4.731|7.538||The model contains neutrophil count at Baseline and treatment as independent variables, fixed effects.|ANCOVA||||
1664794|NCT01473745|3062709|Superiority or Other|||||||0.888|||||||t-test, 2 sided|P value < 0.05 was set as statistical significance.|||
1664795|NCT01473745|3062709|Superiority or Other|||||||0.043||||||Intergroup difference of modified group|t-test, 2 sided|P value <0.05 was set as statistical significance.|||
1664796|NCT01473745|3062709|Superiority or Other|||||||0.104||||||intergroup difference of conventional group|t-test, 2 sided|P value < 0.05 was set as statistical significance.|||
1664797|NCT01473745|3062710|Superiority or Other|||||||0.078|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||upper lip protrusion|
1664798|NCT01473745|3062710|Superiority or Other|||||||0.44|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||lower prolabial width|
1664799|NCT01473745|3062710|Superiority or Other|||||||0.995|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||vermillion height of upper lip|
1664800|NCT01473745|3062710|Superiority or Other|||||||0.057|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||overall upper lip height|
1664801|NCT01473745|3062710|Superiority or Other|||||||0.344|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||cutaneous height of upper lip|
1664802|NCT01473745|3062710|Superiority or Other|||||||0.262|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||columellar length|
1664803|NCT01473745|3062710|Superiority or Other|||||||0.891|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||L nostril show vertical dimension|
1664804|NCT01473745|3062710|Superiority or Other|||||||0.85|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||R nostril show vertical dimension|
1664805|NCT01473745|3062710|Superiority or Other|||||||0.535|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||alar base width|
1664806|NCT01473745|3062710|Superiority or Other|||||||0.115|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||nasal width|
1664807|NCT01473745|3062710|Superiority or Other|||||||0.113|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||nasal tip protrusion|
1664808|NCT01473745|3062710|Superiority or Other|||||||0.136|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||nasal length|
1664809|NCT01473745|3062710|Superiority or Other|||||||0.102|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||nasal height|
1664810|NCT01473745|3062710|Superiority or Other|||||||0.211|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||intercanthal distance|
1664811|NCT01473745|3062710|Superiority or Other|||||||0.011|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||upper lip protrusion|
1664812|NCT01473745|3062710|Superiority or Other|||||||0.029|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||lower prolabial width|
1664813|NCT01473745|3062710|Superiority or Other|||||||0.062|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||vermillion height of upper lip|
1664814|NCT01473745|3062710|Superiority or Other|||||||0.057|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||overall upper lip height|
1664815|NCT01473745|3062710|Superiority or Other|||||||0.049|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||cutaneous height of upper lip|
1664816|NCT01473745|3062710|Superiority or Other|||||||0.358|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||columellar length|
1664817|NCT01473745|3062710|Superiority or Other|||||||0.508|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||L nostril show vertical dimension|
1664818|NCT01473745|3062710|Superiority or Other|||||||0.554|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||R nostril show vertical dimension|
1664819|NCT01473745|3062710|Superiority or Other|||||||0.164|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||alar base width|
1664820|NCT01473745|3062710|Superiority or Other|||||||0.781|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||nasal width|
1664821|NCT01473745|3062710|Superiority or Other|||||||0.565|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||Nasal tip protrusion|
1664822|NCT01473745|3062710|Superiority or Other|||||||0.457|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||Nasal length|
1664823|NCT01473745|3062710|Superiority or Other|||||||0.114|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||nasal height|
1664824|NCT01473745|3062710|Superiority or Other|||||||0.804|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||intercanthal distance|
1664825|NCT01473745|3062710|Superiority or Other|||||||0.706|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||upper lip protrusion|
1664826|NCT01473745|3062710|Superiority or Other|||||||0.25|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||lower prolabial width|
1664827|NCT01473745|3062710|Superiority or Other|||||||0.123|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||vermillion height of upper lip|
1664828|NCT01473745|3062710|Superiority or Other|||||||0.528|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||overall upper lip height|
1664829|NCT01473745|3062710|Superiority or Other|||||||0.116|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||cutaneious height of upper lip|
1664830|NCT01473745|3062710|Superiority or Other|||||||0.008|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||columellar length|
1664831|NCT01473745|3062710|Superiority or Other|||||||0.738|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||L nostril show vertical dimension|
1664832|NCT01473745|3062710|Superiority or Other|||||||0.299|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||R nostril show vertical dimension|
1664833|NCT01473745|3062710|Superiority or Other|||||||0.505|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||alar base width|
1664834|NCT01473745|3062710|Superiority or Other|||||||0.277|||||||t-test, 2 sided|P value < 0.05 was set as statistical significance.||nasal width|
1664835|NCT01473745|3062710|Superiority or Other|||||||0.135|||||||t-test, 2 sided|P value < 0.05 was set as statistical significance.||nasal tip protrusion|
1664836|NCT01473745|3062710|Superiority or Other|||||||0.192|||||||t-test, 2 sided|P- value < 0.05 was set as statistical significance|||
1664837|NCT01473745|3062710|Superiority or Other|||||||0.336|||||||t-test, 2 sided|P- value < 0.05 was set as statistical significance.||nasal height|
1664838|NCT01473745|3062710|Superiority or Other|||||||0.218|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||Intercanthal distance|
1664839|NCT01473745|3062711|Superiority or Other|||||||0.133|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||labiale superious Z axis|
1664840|NCT01473745|3062711|Superiority or Other|||||||0.177|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||labiale superious Y axis|
1664841|NCT01473745|3062711|Superiority or Other|||||||0.422|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||labiale superious X axis|
1664842|NCT01473745|3062711|Superiority or Other|||||||0.034|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||subnasale Z axis|
1664843|NCT01473745|3062711|Superiority or Other|||||||0.019|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||subnasale Y axis|
1664844|NCT01473745|3062711|Superiority or Other|||||||0.119|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||subnasale X axis|
1664845|NCT01473745|3062711|Superiority or Other|||||||0.284|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||pronasale Z axis|
1664846|NCT01473745|3062711|Superiority or Other|||||||0.361|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||pronasale Y axis|
1664847|NCT01473745|3062711|Superiority or Other|||||||0.275|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||pronasale X axis|
1664848|NCT01473745|3062711|Superiority or Other|||||||0.621|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||UI level Z axis|
1664849|NCT01473745|3062711|Superiority or Other|||||||0.426|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||UI level Y axis|
1664850|NCT01473745|3062711|Superiority or Other|||||||0.011|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||UI level X axis|
1664851|NCT01473745|3062711|Superiority or Other|||||||0.371|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||A point X axis|
1664852|NCT01473745|3062711|Superiority or Other|||||||0.323|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||A point Y axis|
1664853|NCT01473745|3062711|Superiority or Other|||||||0.054|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||A point X axis|
1664854|NCT01473745|3062711|Superiority or Other|||||||0.78|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||ANS Z axis|
1664855|NCT01473745|3062711|Superiority or Other|||||||0.389|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||ANS Y axis|
1664856|NCT01473745|3062711|Superiority or Other|||||||0.098|||||||t-test, 2 sided|P-value < 0.05 was set as statistical significance(*).||ANS X axis|
1664857|NCT01473524|3062757|Superiority or Other||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.|||
1664858|NCT01473524|3062757|Superiority or Other||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.|||
1664859|NCT01473524|3062758|Superiority or Other||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor|||
1664860|NCT01473524|3062758|Superiority or Other||||||<|0.0003|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.|||
1664861|NCT01473524|3062759|Superiority or Other||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.|||
1664862|NCT01473524|3062759|Superiority or Other||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.|||
1664863|NCT01473524|3062760|Superiority or Other||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.|||
1664864|NCT01473524|3062760|Superiority or Other||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.|||
1664865|NCT01473524|3062761|Superiority or Other||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.|||
1664866|NCT01473524|3062761|Superiority or Other||||||<|0.0004|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.|||
1664867|NCT01473524|3062762|Superiority or Other||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.|||
1664868|NCT01473524|3062762|Superiority or Other||||||<|0.0001|||||||ANCOVA|ANCOVA model with baseline value as a covariate and fixed effects for treatment and randomization strata factor.|||
1664869|NCT01473524|3062763|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran–Mantel–Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 5-10 mg OCA. H1: The response rates are different between placebo and 5-10 mg OCA.|
1664870|NCT01473524|3062764|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran–Mantel–Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 5-10 mg OCA. H1: The response rates are different between placebo and 5-10 mg OCA.|
1664871|NCT01473524|3062765|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran–Mantel–Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 10 mg OCA. H1: The response rates are different between placebo and 10 mg OCA.|
1664872|NCT01473524|3062766|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran–Mantel–Haenszel (CMH) General Association test stratified by randomization strata factor.||H0: The response rates are equal between placebo and 10 mg OCA. H1: The response rates are different between placebo and 10 mg OCA.|
1664873|NCT01473420|3062789|Superiority or Other|||||||0.9177|||||||Wilcoxon Rank Sum test|P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|||
1664874|NCT01473420|3062790|Superiority or Other|||||||0.6895|||||||Wilcoxon Rank Sum test|P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|||
1664875|NCT01473420|3062791|Superiority or Other|||||||0.8338|||||||Two-sample t-test||||
1664876|NCT01473420|3062792|Non-Inferiority or Equivalence|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|-2.34|Standard Error of the Mean|6.175|||2-Sided|95.0|-14.51|9.82||||||LS mean and 95 percent CI derived from an ANCOVA model with fixed effect of treatment.|
1664877|NCT01473420|3062793|Non-Inferiority or Equivalence|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|0.04|Standard Error of the Mean|0.104|||2-Sided|95.0|-0.17|0.24||||||Least square (LS) mean and 95 percent confidence interval (CI) derived from an analysis of covariance (ANCOVA) model with fixed effect of treatment.|
1664878|NCT01473407|3062813|Superiority or Other|||||||0.3369||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test||||
1664879|NCT01473407|3062814|Superiority or Other|||||||0.1061||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test||||
1664880|NCT01473407|3062815|Superiority or Other|||||||0.7563||||||P-value was calculated from a Wilcoxon Rank Sum test and t-approximation was used.|Wilcoxon Rank Sum test||||
1664881|NCT01473407|3062816|Non-Inferiority or Equivalence|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|0.37|Standard Error of the Mean|5.483|||2-Sided|95.0|-10.4|11.13||||||LS mean and 95 percent CI were derived from an ANCOVA model with fixed effect of treatment.|
1664882|NCT01473407|3062817|Non-Inferiority or Equivalence|An equivalence margin of +/- 0.5 was considered relevant to demonstrate the equivalence of the two products.|LS Mean Difference|-0.12|Standard Error of the Mean|0.066|||2-Sided|95.0|-0.25|0.01||||||Least Square (LS) mean and 95 percent confidence interval (CI) were derived from an ANCOVA model with fixed effect of treatment.|
1664883|NCT01473394|3062818|Superiority or Other||Mean Difference (Final Values)|10.2||||0.0047|2-Sided|95.0|3.0|17.4|||Cochran-Mantel-Haenszel||The Mean Difference (Final Values), as well as the 95% Confidence Interval, are in units of percentage.||
1664884|NCT01473394|3062819|Superiority or Other||Least square mean difference|-0.622|||<|1e-05|2-Sided|95.0|-0.845|-0.399|||Mixed-effects model for repeated measure||||
1664885|NCT01473394|3062820|Superiority or Other||Least square mean difference|-5.117|||<|1e-05|2-Sided|95.0|-6.886|-3.347|||Mixed-effects model for repeated measure||||
1664886|NCT01473381|3062821|Superiority or Other||Mean Difference (Final Values)|4.7||||0.2672|2-Sided|95.0|-2.7|12.2||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.|||
1664887|NCT01473381|3062821|Superiority or Other||Mean Difference (Final Values)|7.1||||0.1611|2-Sided|95.0|-0.4|14.6||P-value was adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.|||
1664888|NCT01473381|3062821|Superiority or Other||Mean Difference (Final Values)|3.5||||0.3563|2-Sided|95.0|-3.9|10.9||P-value was adjusted for multiplicity.|Cochran-Mantel-Haenszel|The Mean Difference (Final Values), as well as 95% Confidence Interval, are in units of percentage.|||
1664889|NCT01473381|3062822|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.0025|2-Sided|95.0|-0.57|-0.12||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Mixed-effect model||||
1664890|NCT01473381|3062822|Superiority or Other||Mean Difference (Final Values)|-0.33||||0.0097|2-Sided|95.0|-0.55|-0.1||P-value was adjusted for multiplicity.|Mixed-effect model||||
1664891|NCT01473381|3062822|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.0073|2-Sided|95.0|-0.58|-0.13||P-value was adjusted for multiplicity.|Mixed-effect model||||
1664892|NCT01473381|3062823|Superiority or Other||Mean Difference (Final Values)|-2.74||||0.002|2-Sided|95.0|-4.48|-1.0||P-value was provided for assay sensitivity. It was not adjusted for multiplicity.|Mixed-effect model||||
1664893|NCT01473381|3062823|Superiority or Other||Mean Difference (Final Values)|-2.82||||0.0034|2-Sided|95.0|-4.57|-1.06||P-value was adjusted for multiplicity.|Mixed-effect model||||
1664894|NCT01473381|3062823|Superiority or Other||Mean Difference (Final Values)|-2.57||||0.0073|2-Sided|95.0|-4.3|-0.84||P-value was adjusted for multiplicity.|Mixed-effect model||||
1664895|NCT01473368|3062826|Superiority or Other||||||<|0.05|||||||ANOVA||||
1664896|NCT01473368|3062830|Superiority or Other|||||||0.026|||||||ANOVA||||
1664897|NCT01472939|3062854|Superiority or Other||Mean Difference (Final Values)|-2.15||||0.114|2-Sided|95.0|-4.813|0.519|||Mixed Models Repeated Measures Analysis||||
1664898|NCT01472939|3062854|Superiority or Other||Mean Difference (Final Values)|-3.2||||0.017|2-Sided|95.0|-5.818|-0.573|||Mixed Models Repeated Measures Analysis||||
1664899|NCT01472939|3062854|Superiority or Other||Mean Difference (Final Values)|-2.47||||0.064|2-Sided|95.0|-5.087|0.141|||Mixed Models Repeated Measures Analysis||||
1664900|NCT01472939|3062855|Superiority or Other||Mean Difference (Final Values)|5.71||||0.175|2-Sided|95.0|-2.54|13.957|||Mixed Models Repeated Measures Analysis||||
1664901|NCT01472939|3062855|Superiority or Other||Mean Difference (Final Values)|8.92||||0.031|2-Sided|95.0|0.814|17.021|||Mixed Models Repeated Measures Analysis||||
1664902|NCT01472939|3062855|Superiority or Other||Mean Difference (Final Values)|6.75||||0.102|2-Sided|95.0|-1.344|14.85|||Mixed Models Repeated Measures Analysis||||
1664903|NCT01472939|3062856|Superiority or Other||Mean Difference (Final Values)|1.83||||0.65|2-Sided|95.0|-6.1|9.765|||Mixed Models Repeated Measures Analysis||||
1664904|NCT01472939|3062856|Superiority or Other||Mean Difference (Final Values)|7.42||||0.062|2-Sided|95.0|-0.378|15.212|||Mixed Models Repeated Measures Analysis||||
1664905|NCT01472939|3062856|Superiority or Other||Mean Difference (Final Values)|6.06||||0.128|2-Sided|95.0|-1.743|13.862|||Mixed Models Repeated Measures Analysis||||
1664906|NCT01472757|3062880|Superiority|||||||0.008|||||||ANCOVA||||
1664907|NCT01472757|3062880|Superiority|||||||0.002|||||||ANCOVA||||
1664908|NCT01472757|3062880|Superiority|||||||0.002|||||||ANCOVA||||
1664909|NCT01472757|3062881|Superiority|||||||0.011|||||||Fisher Exact||||
1664910|NCT01472757|3062881|Superiority|||||||0.006|||||||Fisher Exact||||
1664911|NCT01472757|3062881|Superiority|||||||0.001|||||||Fisher Exact||||
1664912|NCT01472757|3062882|Superiority||||||<|0.001||||||Calculated p-value was less than 0.001.|ANCOVA||||
1664913|NCT01472757|3062882|Superiority||||||<|0.001||||||Calculated p-value was less than 0.001.|ANCOVA||||
1664914|NCT01472757|3062882|Superiority||||||<|0.013|||||||ANCOVA||||
1664915|NCT01472549|3062894|Superiority||Risk Ratio (RR)|2.02||||0.56|2-Sided|95.0|0.18|22.11|||Fisher Exact||||
1664916|NCT01472549|3062895|Superiority|||||||0.08|||||||Fisher Exact||||
1664917|NCT01472549|3062896|Superiority||Risk Ratio (RR)|0.73||||0.49|2-Sided|95.0|0.3|1.8|||Chi-squared||||
1664918|NCT01472549|3062897|Superiority||Risk Ratio (RR)|0.76||||0.37|2-Sided|95.0|0.43|1.37|||Chi-squared||||
1664919|NCT01472549|3062898|Superiority|||||||0.24|||||||Wilcoxon (Mann-Whitney)||||
1664920|NCT01472549|3062899|Superiority||Risk Ratio (RR)|0.55||||0.02|2-Sided|95.0|0.34|0.9|||Chi-squared||||
1664921|NCT01472432|3062911|Superiority or Other||||||<|0.05||||||P< 0.05 versus control patients. P < 0.05 versus baseline|t-test, 2 sided||||
1664922|NCT01472432|3062912|Superiority or Other||||||<|0.05||||||P-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months. P< 0.05 versus control patients. P < 0.05 versus baseline.|t-test, 2 sided|||p-values from multiple comparisons: placebo at baseline vs. placebo at 3 months; placebo at 3 months vs. Vildagliptin at 3 months; Vildagliptin at baseline vs. Vildagliptin at 3 months.|
1664923|NCT01472432|3062913|Superiority or Other||||||<|0.05||||||"Vildagliptin vs Placebo at 3 months.~Placebo baseline versus placebo 3 months.~Vildagliptin baseline versus Vildagliptin 3 months"|t-test, 2 sided|"Vildagliptin vs Placebo at 3 months.~Placebo baseline versus placebo 3 months.~Vildagliptin baseline versus Vildagliptin 3 months"||"Vildagliptin vs Placebo at 3 months.~Placebo baseline versus placebo 3 months.~Vildagliptin baseline versus Vildagliptin 3 months."|
1664924|NCT01472432|3062914|Superiority or Other||||||<|0.05||||||"Vildagliptin vs Placebo at 3 months.~Placebo baseline versus placebo 3 months.~Vildagliptin baseline versus Vildagliptin 3 months."|t-test, 2 sided|"Vildagliptin vs Placebo at 3 months.~Placebo baseline versus placebo 3 months.~Vildagliptin baseline versus Vildagliptin 3 months."||"Vildagliptin vs Placebo at 3 months.~Placebo baseline versus placebo 3 months.~Vildagliptin baseline versus Vildagliptin 3 months."|
1664925|NCT01472341|3062918|Superiority or Other||||||<|0.0001|||||||Multivariate regression analysis|HOMA %B was the response variable and other study parameters were independent variables.|||
1664926|NCT01472341|3062919|Superiority or Other|||||||0.001|||||||Multivariate regression analysis|PI/I ratio was the response variable and other study parameters were independent variables.|||
1664927|NCT01472341|3062920|Superiority or Other|||||||0.24|||||||Multivariate regression analysis|HOMA %B was the response variable and other study parameters were independent variables.|||
1664928|NCT01472185|3062932|Superiority or Other||difference in least squares mean (LSM)|-0.56|||<|0.0001|2-Sided|95.0|-0.76|-0.36||P-value is from a mixed effects model including terms for baseline HbA1c value, treatment group, visit week, and treatment by visit week interaction. Unstructured covariance matrix was used.|Mixed Effects Model Analysis||The estimation (LSM) is of the placebo-corrected change from baseline.|Assuming a common standard deviation of 1.2%, an effective sample size of 400 would provide at least 90% power to detect a statistically significant treatment difference of -0.5% (ranolazine vs. placebo) for the reduction of HbA1c from baseline at Week 24 based on a 2-sided alpha of 0.05 and 1:1 randomization.|
1664929|NCT01471340|3062967|Superiority or Other||Hazard Ratio (HR)|0.89||||0.021|2-Sided|95.0|0.8|0.98|||Cox proportional-hazard model|Superiority of MF/F MDI BID vs MF MDI BID was determined if the HR was less than 1 and achieved statistical significance (one-sided p-value < 0.025).|The HR and 95% CI were based on the Cox proportional-hazard model with covariates of treatment (MF/F or MF) and ICS dose level (200 or 400 mcg).|Pertains only to the First SAEX; pooled MF/F treatments and pooled MF treatments|
1664930|NCT01471340|3062968|Non-Inferiority or Equivalence|The projected sample size provided 90% power at a 2.5% alpha level (one-sided) to determine non-inferiority of MF/F and MF. For analysis of the first SAO in participants, MF/F MDI BID was considered non-inferior to MF MDI BID if the upper bound for the 95% confidence interval (CI) of the hazard ratio (HR) of MF/F MDI BID versus MF MDI BID was lower than 2.0 (noninferiority margin).|Hazard Ratio (HR)|1.22||||0.411|2-Sided|95.0|0.76|1.94|||Cox proportional-hazard model||The HR and 95% CI were based on the Cox proportional-hazard model with covariates of treatment (MF/F or MF) and ICS dose level (200 or 400 mcg).|Pertains only to the First SAO; pooled MF/F treatments and pooled MF treatments|
1664931|NCT01471028|3062994|Superiority||Hazard Ratio (HR)|0.283||||0.007|2-Sided|95.0|0.109|0.732|||Log Rank||||
1664932|NCT01471028|3062995|Superiority||Hazard Ratio (HR)|1.315||||0.168|2-Sided|95.0|0.886|1.952|||Log Rank||||
1664933|NCT01471028|3062996|Superiority|||||||0.737|||||||Chi-squared||||
1664934|NCT01471028|3062997|Superiority||Hazard Ratio (HR)|1.027||||0.904|2-Sided|95.0|0.689|1.53|||Log Rank|||The primary endpoint was assessed using a Kaplan-Meier survival analysis of the Intent-to-treat (ITT) population utilizing a log-rank test.|
1664935|NCT01471015|3062998|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)||||
1664936|NCT01471015|3062999|Superiority or Other|||||||0.006|||||||Wilcoxon (Mann-Whitney)||||
1664937|NCT01470859|3063001|Superiority or Other|||||||0.41||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|Chi-squared|The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V5|||
1664938|NCT01470859|3063001|Superiority or Other|||||||0.345||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|Chi-squared|The statistical analysis was performed to compare the clinical improvement between levodopa and pramipexole groups at V2|||
1664939|NCT01470859|3063002|Superiority or Other|||||||0.43||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the H&Y stages between levodopa and pramipexole groups at V5|||
1664940|NCT01470859|3063002|Superiority or Other|||||||0.793||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|indenpendent U test|independent U test The statistical analysis was performed to compare the H&Y stages between levodopa and pramipexole group at V1|||
1664941|NCT01470859|3063003|Superiority or Other|||||||0.867||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V5|||
1664942|NCT01470859|3063003|Superiority or Other|||||||0.72||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the PDQ39 scores between levodopa and pramipexole group at V1|||
1664943|NCT01470859|3063004|Superiority or Other|||||||0.874||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V5 scores between the levodopa and pramipexole groups|||
1664944|NCT01470859|3063004|Superiority or Other|||||||0.049||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V2 scores between the levodopa and pramipexole groups|||
1664945|NCT01470859|3063004|Superiority or Other|||||||0.341||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS III scores at V1 scores between the levodopa and pramipexole groups|||
1664946|NCT01470859|3063004|Superiority or Other|||||||0.635||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V5 scores between the levodopa and pramipexole groups|||
1664947|NCT01470859|3063004|Superiority or Other|||||||0.706||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V2 scores between the levodopa and pramipexole groups|||
1664948|NCT01470859|3063004|Superiority or Other|||||||0.691||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|independent U test|independent U test The statistical analysis was performed to compare the UPDRS II scores at V1 scores between the levodopa and pramipexole groups|||
1664979|NCT01469182|3063143|Superiority or Other||Percent Difference|5.25|||<|0.001|2-Sided|95.0|3.3|7.4|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor|||
1664949|NCT01470859|3063005|Superiority or Other|||||||0.31||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V5|||
1664950|NCT01470859|3063005|Superiority or Other|||||||0.93||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed to compare the PDRP Z scores between levodopa and pramipexole groups at V1|||
1664951|NCT01470859|3063005|Superiority or Other|||||||0.84||||||"p<0.05 is indicating the threshold for statistical significance for this comparison"|t-test, 2 sided|independent sample t-test The statistical analysis was performed on the changes of PDRP Z score between levodopa and pramipexole groups.|||
1664952|NCT01470001|3063095|Superiority or Other||Mean Difference (Final Values)|-5.7||||0.44|2-Sided|95.0|-17.5|6.2||p value was adjusted for age.|ANCOVA||we calculated the estimated difference in change between the placebo and treatment groups.|the difference in change between the groups was measured|
1664953|NCT01470001|3063096|Superiority or Other||Mean Difference (Net)|14.3||||0.0919|2-Sided|95.0|-2.3|30.8|||Regression, Logistic|logistic regression with repeated measurements|||
1664954|NCT01470001|3063097|Superiority or Other||Mean Difference (Final Values)|17.7||||0.1135|2-Sided|95.0|-4.3|39.7|||Mixed Models Analysis|mixed model with repeated measurements||A planned sample size of 56 subjects per group provided 80% power to detect a difference of 0.25 between post void dribbling response rates (assumed to be 0.35 under the null hypothesis and 0.60 under the alternative hypothesis) at a one-sided 0.05 significance level.|
1664955|NCT01469819|3063099|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1664956|NCT01469819|3063100|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1664957|NCT01469819|3063101|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1664958|NCT01469819|3063102|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1664959|NCT01469637|3063109|Non-Inferiority or Equivalence|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|1.12|||||2-Sided|90.0|1.09|1.15|||||||
1664960|NCT01469637|3063110|Non-Inferiority or Equivalence|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean ratio|1.15|||||2-Sided|90.0|1.12|1.18|||||||
1664961|NCT01469377|3063115|Superiority||Least squares mean difference|-1.4||||0.114|2-Sided|95.0|-2.8|0.0||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.|||
1664962|NCT01469377|3063115|Superiority||Least squares mean difference|-1.1||||0.2404|2-Sided|95.0|-2.5|0.3||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.|||
1664963|NCT01469377|3063116|Superiority||Least squares mean difference|-2.2||||0.0114|2-Sided|95.0|-3.7|-0.6||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.|||
1664964|NCT01469377|3063116|Superiority||Least squares mean difference|-0.9||||0.2404|2-Sided|95.0|-2.4|0.6||p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Mixed-effect model for repeated measures|p-values were adjusted for multiple comparisons using the matched parallel gate-keeping procedure.|||
1664965|NCT01469364|3063117|Superiority or Other|||||||0.9638|||||||t-test, 2 sided|Paired t-test was completed.|||
1664966|NCT01469364|3063118|Superiority or Other|||||||0.7454|||||||t-test, 2 sided|Paired t-test 2 sided.|||
1664967|NCT01469364|3063119|Superiority or Other||Median Absolute Difference|0.15||||0.68|2-Sided||||||t-test, 2 sided|Paired Measure t-test||P-Value for SGRQ Measure|
1664968|NCT01469364|3063120|Superiority or Other||Median Absolute Difference|0.82||||0.56|2-Sided||||||t-test, 2 sided|Paired Measure t-test||P-Value for SGRQ measure|
1664969|NCT01469364|3063121|Superiority or Other||Median Absolute Difference|-1.24||||0.31|2-Sided||||||t-test, 2 sided|Paired Measure t-test||P-Value for SF-36 MCS|
1664970|NCT01469364|3063121|Superiority or Other||Median Absolute Difference|1.62||||0.09|2-Sided||||||t-test, 2 sided|Paired Measure t-test||P-Value for SF-36 PCS|
1664971|NCT01469364|3063122|Superiority or Other||Median Absolute Difference|0.78||||0.18|2-Sided||||||t-test, 2 sided|Paired Measured t-test||P-Value for the SF-36 MCS|
1664972|NCT01469364|3063122|Superiority or Other||Mean Absolute Difference|-1.52||||0.34|2-Sided||||||t-test, 2 sided|Paired Measured t-test||P-Value for the SF-36 PCS|
1664973|NCT01469364|3063127|Superiority or Other|||||||0.2527|||||||t-test, 2 sided|Paired t-test 2 sided.|||
1664974|NCT01469364|3063128|Superiority or Other|||||||0.203|||||||t-test, 2 sided|Paired t-test 2 sided.|||
1664975|NCT01469182|3063139|Superiority or Other||Percent Difference|2.46||||0.029|2-Sided|95.0|0.3|4.4|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor|||
1664976|NCT01469182|3063140|Superiority or Other||Percent Difference|0.99||||0.382|2-Sided|95.0|-1.5|3.0|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor|||
1664977|NCT01469182|3063141|Superiority or Other||Percent Difference|1.15||||0.344||95.0|-1.5|3.3|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor|||
1664978|NCT01469182|3063142|Superiority or Other||Percent Difference|0.17||||0.861|2-Sided|95.0|-2.1|1.9|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor|||
1664980|NCT01469182|3063144|Superiority or Other||Percent Difference|10.17|||<|0.001|2-Sided|95.0|6.6|13.6|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor|||
1664981|NCT01469182|3063145|Superiority or Other||Percent Difference|7.88|||<|0.001|2-Sided|95.0|5.5|10.5|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor|||
1664982|NCT01469182|3063146|Superiority or Other||Percent Difference|5.58|||<|0.001|2-Sided|95.0|2.9|8.2|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor|||
1664983|NCT01469182|3063147|Superiority or Other||Percent Difference|9.95||||0.005|2-Sided|95.0|3.1|16.7|||Stratified Miettinen and Nurminen|Baseline asthmatic status as the factor|||
1664984|NCT01469065|3063149|Superiority or Other||Test-to-Reference Ratio (%)|91.7|||||2-Sided|90.0|84.38|99.65||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664985|NCT01469065|3063149|Superiority or Other||Test-to-Reference Ratio (%)|96.07|||||2-Sided|90.0|88.51|104.27||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664986|NCT01469065|3063149|Superiority or Other||Test-to-Reference Ratio (%)|92.57|||||2-Sided|90.0|85.26|100.5||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664987|NCT01469065|3063149|Superiority or Other||Test-to-Reference Ratio (%)|107.13|||||2-Sided|90.0|98.69|116.3||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in C-peptide AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664988|NCT01469065|3063150|Superiority or Other||Test-to-Reference Ratio (%)|96.73|||||2-Sided|90.0|85.46|109.48||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664989|NCT01469065|3063150|Superiority or Other||Test-to-Reference Ratio (%)|111.04|||||2-Sided|90.0|98.5|125.18||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664990|NCT01469065|3063150|Superiority or Other||Test-to-Reference Ratio (%)|102.11|||||2-Sided|90.0|90.78|114.85||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664991|NCT01469065|3063150|Superiority or Other||Test-to-Reference Ratio (%)|112.83|||||2-Sided|90.0|99.84|127.5||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Insulin AUC(2-6) (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664992|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 15|93.18|||||2-Sided|90.0|86.17|100.77||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664993|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 15|94.75|||||2-Sided|90.0|87.69|102.34||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664994|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 15|90.45|||||2-Sided|90.0|84.03|98.08||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664995|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 15|90.45|||||2-Sided|90.0|83.75|97.69||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 15 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664996|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 14|88.6|||||2-Sided|90.0|82.0|95.74||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665077|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-63.17|||<|0.001|2-Sided|95.0|-69.16|-57.18|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-midday meal at 52 Weeks|
1664997|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 14|91.35|||||2-Sided|90.0|84.55|98.7||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664998|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 14|87.87|||||2-Sided|90.0|81.34|94.93||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1664999|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 14|86.75|||||2-Sided|90.0|80.32|93.69||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 14 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665000|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 10|94.5|||||2-Sided|90.0|87.46|102.11||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665001|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 10|99.63|||||2-Sided|90.0|92.21|107.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665002|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 10|96.05|||||2-Sided|90.0|88.9|103.76||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665003|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 10|96.91|||||2-Sided|90.0|89.72|104.67||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 10 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665004|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 6|87.74|||||2-Sided|90.0|81.2|94.81||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665005|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 6|94.08|||||2-Sided|90.0|87.08|101.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665006|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 6|92.71|||||2-Sided|90.0|85.81|100.15||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665007|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 6|93.43|||||2-Sided|90.0|86.5|100.91||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 6 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665008|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 3|94.49|||||2-Sided|90.0|87.53|102.1||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665009|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 3|99.72|||||2-Sided|90.0|92.3|107.73||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665026|NCT01469065|3063166|Superiority or Other||Test-to-Reference Ratio (%)|87.15|||||2-Sided|90.0|80.27|94.63||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665010|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 3|98.71|||||2-Sided|90.0|91.37|106.64||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665011|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 3|95.85|||||2-Sided|90.0|88.82|103.44||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 3 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665012|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 2|96.82|||||2-Sided|90.0|89.69|104.52||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665013|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 2|101.67|||||2-Sided|90.0|94.1|109.84||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665014|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 2|99.44|||||2-Sided|90.0|92.04|107.43||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665015|NCT01469065|3063151|Superiority or Other||Test-to-Reference Ratio (%) at Day 2|100.04|||||2-Sided|90.0|92.7|107.96||||||Test-to-Reference ratio of log-transformed change from baseline and 90% confidence interval (CI) of log-transformed change from baseline at Day 2 were based on adjusted geometric mean. Natural log-transformed change from baseline in FPG was analyzed using mixed effects model with country, treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665016|NCT01469065|3063152|Superiority or Other||Test-to-Reference Ratio (%)|77.95|||||2-Sided|90.0|72.91|83.34||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665017|NCT01469065|3063152|Superiority or Other||Test-to-Reference Ratio (%)|87.05|||||2-Sided|90.0|81.44|93.04||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665018|NCT01469065|3063152|Superiority or Other||Test-to-Reference Ratio (%)|91.13|||||2-Sided|90.0|85.24|97.44||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665019|NCT01469065|3063152|Superiority or Other||Test-to-Reference Ratio (%)|86.72|||||2-Sided|90.0|81.13|92.7||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in Glucose AUC(2-6) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665020|NCT01469065|3063153|Superiority or Other||Difference between Test and Reference|-35.84|||||2-Sided|90.0|-52.89|-18.78||||||Treatment difference and 90% confidence interval (CI) were based on adjusted geometric mean.|
1665021|NCT01469065|3063153|Superiority or Other||Test-to-Reference Ratio (%)|75.82|||||2-Sided|90.0|69.78|82.39||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665022|NCT01469065|3063153|Superiority or Other||Test-to-Reference Ratio (%)|85.37|||||2-Sided|90.0|78.59|92.76||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665023|NCT01469065|3063153|Superiority or Other||Test-to-Reference Ratio (%)|85.39|||||2-Sided|90.0|78.6|92.77||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665024|NCT01469065|3063153|Superiority or Other||Test-to-Reference Ratio (%)|82.69|||||2-Sided|90.0|76.06|89.9||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 13) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665025|NCT01469065|3063166|Superiority or Other||Test-to-Reference Ratio (%)|78.28|||||2-Sided|90.0|72.06|85.03||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665027|NCT01469065|3063166|Superiority or Other||Test-to-Reference Ratio (%)|89.8|||||2-Sided|90.0|82.69|97.53||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test.|
1665028|NCT01469065|3063166|Superiority or Other||Test-to-Reference Ratio (%)|84.87|||||2-Sided|90.0|78.16|92.15||||||Test-to-Reference ratio and 90% confidence interval (CI) were based on adjusted geometric mean. Natural log-transformed change from baseline in MDG (Day 14) was analyzed using ANCOVA with country and treatment as fixed effect and log-transformed baseline as covariate. Placebo is the reference; the active drug group is the test. Formal statistical inference was not performed thus p value was not reported.|
1665029|NCT01469039|3063178|Superiority or Other||||||<|0.001||||||significant p-value, active vs placebo|Wilcoxon rank sum test based on LOCF||||
1665030|NCT01469039|3063178|Superiority or Other||||||<|0.001||||||significant p-value, active vs placebo|Wilcoxon rank sum test based on LOCF||||
1665031|NCT01469039|3063179|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1665032|NCT01469039|3063179|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1665033|NCT01469013|3063197|Superiority or Other (legacy)|||||||0.009|||||||Cochran-Armitage trend test||||
1665034|NCT01469013|3063199|Superiority or Other (legacy)||||||<|0.001|||||||Regression, Logistic||||
1665035|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|0.65|||||2-Sided|95.0|0.41|1.03||||||Observer-rated Pain: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)|
1665036|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|1.32|||||2-Sided|95.0|0.6|2.91||||||Observer-rated Hemoptysis: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)|
1665037|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|1.09|||||2-Sided|95.0|0.64|1.83||||||Observer-rated Dyspnea: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)|
1665038|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|1.24|||||2-Sided|95.0|0.72|2.15||||||Observer-rated Cough:Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)|
1665039|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|1.26|||||2-Sided|95.0|0.82|1.93||||||Observer-rated Fatigue: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)|
1665040|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|1.56|||||2-Sided|95.0|0.97|2.49||||||Observer-rated Loss of Appetite: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (Severe) to 100 (None). This scoring system is the reverse of the patient scale. The observer scale is a categorical 5-point scale and specific descriptors are provided with each questions for each of the scores (0,25,50,75 and 100)|
1665041|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|1.12|||||2-Sided|95.0|0.72|1.74||||||Patient-rated Quality of Life: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).|
1665042|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|1.38|||||2-Sided|95.0|0.88|2.17||||||Patient-rated Interference: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).|
1665043|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|1.1|||||2-Sided|95.0|0.68|1.77||||||Patient-rated Overall Symptoms: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).|
1665044|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|1.11|||||2-Sided|95.0|0.64|1.91||||||Patient-rated Pain: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).|
1665045|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|0.57|||||2-Sided|95.0|0.32|1.02||||||Patient-rated Hemoptysis: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).|
1665046|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|1.06|||||2-Sided|95.0|0.65|1.71||||||Patient-rated Dyspnea: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).|
1665047|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|1.39|||||2-Sided|95.0|0.84|2.3||||||Patient-rated Cough: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).|
1665048|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|0.92|||||2-Sided|95.0|0.6|1.42||||||Patient-rated Fatigue: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).|
1665049|NCT01469000|3063200|Superiority||Hazard Ratio (HR)|1.17|||||2-Sided|95.0|0.77|1.78||||||Patient-rated Loss of Appetite: Time to worsening of symptom (TWS) was measured from the date of randomization to the first date of a 15-millimeter(mm) worsening from baseline on a scale of 0 (no symptoms) to 100 (as much as it could be).|
1665050|NCT01469000|3063204|Superiority or Other (legacy)||Hazard Ratio (HR)|0.77||||0.105|2-Sided|95.0|0.51|1.16||1 sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.|||
1665051|NCT01469000|3063205|Superiority or Other (legacy)||Hazard Ratio (HR)|0.64||||0.005|2-Sided|95.0|0.46|0.9||1 sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.|||
1665052|NCT01469000|3063206|Superiority or Other (legacy)||Hazard Ratio (HR)|0.67||||0.009|2-Sided|95.0|0.48|0.93||1-sided.|Regression, Cox|Adjusted for gender, performance status, previous adjuvant /neoadjuvant treatment, age, smoking history, mutation type, and country.|||
1665053|NCT01468233|3063402|Superiority or Other||LS mean difference|-19.4|||<|0.001|2-Sided|95.0|-28.6|-10.1||P-value calculated from ANCOVA with stratum (baseline Hurley Stage and antibiotics use), baseline value, and treatment as covariates.|ANCOVA|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.|
1665054|NCT01468233|3063403|Superiority or Other||Adjusted mean difference|25.1|||<|0.001|2-Sided|95.0|12.7|37.6||P-value adjusted for baseline Hurley Stage and antibiotics use (Y/N).|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.|
1665055|NCT01468233|3063404|Superiority or Other||Adjusted mean difference|19.5|||=|0|2-Sided|95.0|4.7|34.2||P-value adjusted for baseline antibiotics use (Y/N).|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.|
1665056|NCT01468233|3063405|Superiority or Other||Adjusted mean difference|38.1|||<|0.001|2-Sided|95.0|22.8|53.3||P-value adjusted for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel||||
1665057|NCT01468233|3063405|Superiority or Other||Adjusted mean difference|25.5|||<|0.001|2-Sided|95.0|10.5|40.5||P-value adjusted for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel||||
1665058|NCT01468233|3063405|Superiority or Other||Adjusted mean difference|31.5|||<|0.001|2-Sided|95.0|20.7|42.2||P-value adjusted for baseline Hurley Stage and for baseline antibiotic use (Y/N).|Cochran-Mantel-Haenszel||||
1665059|NCT01468207|3063406|Superiority or Other||LS mean difference|-8.7|||=|0|2-Sided|95.0|-19.7|2.4|||ANCOVA|P-value calculated from ANCOVA with stratum, baseline, and treatment as covariates.||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.|
1665060|NCT01468207|3063407|Superiority or Other||Adjusted mean difference|2.8|||=|0|2-Sided|95.0|-8.6|14.2||P-value adjusted for baseline Hurley Stage.|Cochran-Mantel-Haenszel|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.|
1665061|NCT01468207|3063408|Superiority or Other||Mean Difference (Final Values)|0.3|||=|0|2-Sided|95.0|-13.4|14.1|||Chi-squared|||Secondary end points 1 (AN 0/1/2 counts), 2 (NRS30), and 3 (modified Sartorius score) were ranked analyses.|
1665062|NCT01468207|3063409|Superiority or Other||Mean Difference (Final Values)|17.1|||=|0|2-Sided|95.0|2.2|32.1|||Chi-squared||||
1665063|NCT01468207|3063409|Superiority or Other||Mean Difference (Final Values)|14.8|||=|0|2-Sided|95.0|0.3|29.3|||Chi-squared||||
1665064|NCT01468207|3063409|Superiority or Other||Adjusted mean difference|15.9|||=|0|2-Sided|95.0|5.3|26.5||P-value adjusted for baseline Hurley Stage.|Cochran-Mantel-Haenszel||||
1665065|NCT01468181|3063410|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.4|2-Sided|65.0|-5.68|2.27|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-S% at 52 Weeks|
1665066|NCT01468181|3063410|Superiority or Other||Mean Difference (Final Values)|-2.57||||0.194|2-Sided|95.0|-6.46|1.32|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-S% at 26 Weeks|
1665067|NCT01468181|3063410|Superiority or Other||Mean Difference (Final Values)|27.57|||<|0.001|2-Sided|95.0|24.73|30.41|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-B% at 52 Weeks|
1665068|NCT01468181|3063410|Superiority or Other||Mean Difference (Final Values)|28.59|||<|0.001|2-Sided|95.0|26.0|31.18|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HOMA2-B% at 26 Weeks|
1665069|NCT01468181|3063411|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.382|2-Sided|95.0|-0.42|0.16|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Body weight at 52 Weeks|
1665070|NCT01468181|3063411|Superiority or Other||Mean Difference (Final Values)|-0.14|||<|0.277|2-Sided|95.0|-0.4|0.12|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Body weight at 26 Weeks|
1665071|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-60.16|||<|0.001|2-Sided|95.0|-66.07|-54.25|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Bedtime meal at 52 Weeks|
1665072|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-61.15|||<|0.001|2-Sided|95.0|-66.93|-55.37|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Bedtime meal at 26 Weeks|
1665073|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-60.84|||<|0.001|2-Sided|95.0|-66.95|-54.74|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-evening meal at 52 Weeks|
1665074|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-62.91|||<|0.001|2-Sided|95.0|-69.32|-56.5|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-evening meal at 26 Weeks|
1665075|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-43.88|||<|0.001|2-Sided|95.0|-49.55|-38.21|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-evening meal at 52 Weeks|
1665076|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-44.0|||<|0.001|2-Sided|95.0|-49.67|-38.34|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-evening meal at 26 Weeks|
1665214|NCT01462435|3064102|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1665078|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-67.06|||<|0.001|2-Sided|95.0|-73.02|-61.11|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-midday meal at 26 Weeks|
1665079|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-47.51|||<|0.001|2-Sided|95.0|-52.77|-42.24|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-midday meal at 52 Weeks|
1665080|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-48.21|||<|0.001|2-Sided|95.0|-53.32|-43.09|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-midday meal at 26 Weeks|
1665081|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-66.08|||<|0.001|2-Sided|95.0|-72.12|-60.04|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-morning meal at 52 Weeks|
1665082|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-68.48|||<|0.001|2-Sided|95.0|-74.18|-62.79|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||2 hours post-morning meal at 26 Weeks|
1665083|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-42.6|||<|0.001|2-Sided|95.0|-46.44|-38.76|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-morning meal at 52 Weeks|
1665084|NCT01468181|3063412|Superiority or Other||Mean Difference (Final Values)|-42.42|||<|0.001|2-Sided|95.0|-46.55|-38.29|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||Pre-morning meal at 26 Weeks|
1665085|NCT01468181|3063413|Superiority or Other||Mean Difference (Final Values)|-42.6|||<|0.001|2-Sided|95.0|-46.4|-38.7|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||FBG at 52 Weeks|
1665086|NCT01468181|3063413|Superiority or Other||Median Difference (Final Values)|-43.9|||<|0.001|2-Sided|95.0|-47.8|-40.0|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||FBG at 26 Weeks|
1665087|NCT01468181|3063415|Superiority or Other||Mean Difference (Final Values)|-1.65|||<|0.001|2-Sided|95.0|-1.75|-1.55|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HbA1c at 52 Weeks|
1665088|NCT01468181|3063415|Superiority or Other||Mean Difference (Final Values)|-1.77|||<|0.001|2-Sided|95.0|-1.87|-1.67|||t-test, 2 sided|p-values are from within-group change t-test at the level of 0.05||HbA1c at 26 Weeks|
1665089|NCT01468077|3063433|Superiority or Other||Risk Difference (RD)|0.0164|||||2-Sided|95.0|-0.2685|0.2988|||||The CI (confidence interval) is calculated by Exact method based on binomial distribution.||
1665090|NCT01467713|3063468|Superiority or Other||Hazard Ratio (HR)|1.08||||0.808|2-Sided|98.3|0.6|1.95|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.||
1665091|NCT01467713|3063468|Superiority or Other||Hazard Ratio (HR)|0.79||||0.332|2-Sided|98.3|0.42|1.49|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.||
1665092|NCT01467713|3063468|Superiority or Other||Hazard Ratio (HR)|0.88||||0.286|2-Sided|98.3|0.48|1.61|||Log Rank||Cox proportional hazards model with treatment, pooled center, age, gender, and baseline MADRS score in the model.||
1665093|NCT01467713|3063468|Superiority or Other||Hazard Ratio (HR)|1.06||||0.808|2-Sided|98.3|0.6|1.86|||Log Rank||Cox proportional hazards model with only treatment in the model.||
1665094|NCT01467713|3063468|Superiority or Other||Hazard Ratio (HR)|0.78||||0.332|2-Sided|98.3|0.43|1.43|||Log Rank||Cox proportional hazards model with only treatment in the model.||
1665095|NCT01467713|3063468|Superiority or Other||Hazard Ratio (HR)|0.77||||0.286|2-Sided|98.3|0.42|1.39|||Log Rank||Cox proportional hazards model with only treatment in the model.||
1665096|NCT01467700|3063476|Superiority or Other||LS Mean Difference|6.4|Standard Error of the Mean|2.23||0.002|2-Sided|99.0|0.6|12.1||P-values were from an MMRM model with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Mixed Models Analysis||||
1665097|NCT01467700|3063476|Superiority or Other||LS Mean Difference|0.8|Standard Error of the Mean|2.25||0.361|2-Sided|98.0|-4.5|6.1||P-values were from an MMRM model with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Mixed Models Analysis||||
1665098|NCT01467700|3063476|Superiority or Other||LS Mean Difference|4.7|Standard Error of the Mean|2.22||0.017|2-Sided|98.0|-0.5|9.9||P-values were from an MMRM model with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Mixed Models Analysis||||
1665099|NCT01467700|3063477|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|1.29||0.4|2-Sided|99.0|-3.7|3.0||P-values were from an MMRM model with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Mixed Models Analysis||||
1665100|NCT01467700|3063477|Superiority or Other||LS Mean Difference|2.6|Standard Error of the Mean|1.29||0.979|2-Sided|98.0|-0.4|5.7||P-values were from an MMRM model with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Mixed Models Analysis||||
1665101|NCT01467700|3063477|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|1.28||0.518|2-Sided|98.0|-2.9|3.1||P-values were from an MMRM model with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Mixed Models Analysis||||
1665102|NCT01467570|3063502|Non-Inferiority or Equivalence|The differences between study groups were considered significant when the p value was <0.05 or when the 95% CI for RD or MD did not include 0 (equivalent to p < 0.05).||||||0.28|||||||t-test, 1 sided||||
1665103|NCT01467466|3063535|Superiority||Odds Ratio (OR)|1.02||||0.86|2-Sided|95.0|0.78|1.34|||Wald's Chi-Square||||
1665104|NCT01467466|3063536|Superiority||Odds Ratio (OR)|0.95||||0.7|2-Sided|95.0|0.73|1.24|||Wald's Chi-Square||||
1665105|NCT01467037|3063559|Superiority or Other||Adjusted OR|0.075|||||2-Sided|95.0|0.018|0.307|||||Conditional logistic regression was used. Adjusted VE = (1 - adjusted OR) *100||
1665106|NCT01467037|3063559|Superiority or Other||Adjusted OR|0.088|||||2-Sided|95.0|0.02|0.384|||||Conditional logistic regression was used. Adjusted VE = (1 - adjusted OR) *100||
1665107|NCT01466985|3063565|Superiority|Doravirine was declared superior to placebo when the upper bound of the 90% CI was <-1.|LS mean difference|-1.26|||<|0.001|2-Sided|90.0|-1.51|-1.02|||ANCOVA||||
1665108|NCT01466985|3063565|Superiority|Doravirine was declared superior to placebo when the upper bound of the 90% CI was <-1.|Least squares (LS) mean difference|-1.37|||<|0.001||90.0|-1.6|-1.02|||ANCOVA||||
1665109|NCT01466881|3063566|Superiority or Other|||||||0.2316|||||||Wilcoxon (Mann-Whitney)|Two-sided alpha level of 0.05||The null hypothesis is that there is no significant difference in Aurora kinase A expression between responders and non-responders.|
1665110|NCT01466751|3063585|Superiority or Other||Type III Tests of Fixed Effects|2.032||||0.156|2-Sided|||||No adjustment for multiple comparisons. The a priori threshold was: p < 0.05.|Mixed Models Analysis|Numerator degrees of freedom: 1, Denominator degrees of freedom: 168||A linear mixed model was used to test the null hypothesis that the two treatment groups would display no differential changes in amygdala BOLD signal from baseline to 3 months as a main effect or in interaction with facial affect type (fear or happy) or by brain hemisphere (left or right).|
1665111|NCT01466751|3063586|Superiority or Other||Type III Tests of Fixed Effects|8.687||||0.004|2-Sided|||||A-priori threshold for statistical significance: p < 0.05. No correction for multiple comparisons. The omnibus effect from the linear mixed model for the Treatment Arm x Time Interaction was utilized to establish significance of the effect.|Mixed Models Analysis|Numerator degrees of freedom=1, Denominator degrees of freedom = 168||A linear mixed model was utilized to test the null hypothesis that the intervention groups would show equivalent performance change on the outcome measure from baseline to the 3 month time points.|
1665112|NCT01466660|3063597|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.5|Standard Error of the Mean|1.21||0.2032|2-Sided|95.0|-3.9|0.8||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib divided by Gefitinib|"EQ-VAS utility score.~Exploratory trial, no formal hypotheses were tested."|
1665113|NCT01466660|3063597|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.016||0.054|2-Sided|95.0|-0.06|0.0||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib divided by Gefitinib|"EQ-5D Belgium utility score.~Exploratory trial, no formal hypotheses were tested."|
1665114|NCT01466660|3063597|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.017||0.1422|2-Sided|95.0|-0.06|0.01||p-value was not adjusted for multiple comparisons|Mixed Models Analysis|Adjusted for EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib minus Gefitinib|"EQ-5D UK utility score.~Exploratory trial, no formal hypotheses were tested."|
1665115|NCT01466660|3063598|Superiority or Other (legacy)||Mean Difference (Final Values)|-3.45|Standard Error of the Mean|1.87||0.0657|2-Sided|95.0|-7.13|0.23||p-value was not adjusted for multiple comparisons|ANCOVA|Adjusted for baseline sum of diameters, EGFR mutation group and presence of brain metastases at baseline|Difference calculated as Afatinib minus Gefitinib|Exploratory trial, no formal hypotheses were tested.|
1665116|NCT01466660|3063600|Superiority or Other (legacy)||Odds Ratio (OR)|1.138||||0.7856|2-Sided|95.0|0.447|2.896||p-value was not adjusted for multiple comparisons|Regression, Logistic|Stratified for EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.|
1665117|NCT01466660|3063603|Superiority or Other (legacy)||Odds Ratio (OR)|1.307||||0.3235|2-Sided|95.0|0.768|2.223||p-value was not adjusted for multiple comparisons|Regression, Logistic|Stratified for EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.|
1665118|NCT01466660|3063604|Superiority or Other (legacy)||Hazard Ratio (HR)|0.862||||0.2343|2-Sided|95.0|0.674|1.101||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by EGFR mutation group and presence of brain metastases at baseline|A Cox proportional hazards model, stratified by EGFR mutation group and presence of baseline brain metastases was used to estimate the hazard ratio calculated as Afatinib divided by Gefitinib.|Exploratory trial, no formal hypotheses were tested.|
1665119|NCT01466660|3063605|Superiority or Other (legacy)||Hazard Ratio (HR)|0.75||||0.0136|2-Sided|95.0|0.595|0.944||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by EGFR mutation group and presence of brain metastases at baseline|Ratio calculated as Afatinib divided by Gefitinib|Exploratory trial, no formal hypotheses were tested.|
1665120|NCT01466660|3063606|Superiority or Other (legacy)||Hazard Ratio (HR)|0.822||||0.0891|2-Sided|95.0|0.655|1.032||p-value was not adjusted for multiple comparisons|Log Rank|Stratified by Epidermal Growth Factor Receptor (EGFR) mutation group and presence of brain metastases at baseline|A Cox proportional hazards model, stratified by EGFR mutation group and presence of baseline brain metastases was used to estimate the hazard ratio calculated as Afatinib divided by Gefitinib.|Exploratory trial, no formal hypotheses were tested.|
1665121|NCT01466595|3063649|Superiority or Other|||||||0.028||||||not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|no other adjustments||"Null hypothesis:~There is no difference between the two arms in the change in T-cell activation from baseline to week 4"|
1665122|NCT01466387|3063662|Non-Inferiority or Equivalence|GMC JE + Rab + MenACWY-CRM/GMC JE + Rab.|Ratio of GMC|0.91|||||2-Sided|95.0|0.71|1.17||||||The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean concentrations between the second dose of Japanese encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese encephalitis and rabies virus vaccines given alone was greater than 0.5.|
1665123|NCT01466387|3063663|Non-Inferiority or Equivalence|GMT JE + Rab + MenACWY-CRM/GMT JE + Rab.|Ratio of GMT|0.9|||||2-Sided|95.0|0.7|1.16||||||The primary criterion for immunogenicity (postvaccination, day 57) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between the second dose of Japanese Encephalitis and third dose of rabies virus vaccines given concomitantly with MenACWY-CRM197 to Japanese Encephalitis and rabies virus vaccines given alone was greater than 0.5.|
1665124|NCT01466387|3063664|Non-Inferiority or Equivalence|GMT TF+YF+MenACWY/GMT TF+YF.|Ratio of GMT.|0.96|||||2-Sided|95.0|0.65|1.41||||||The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two sided 95% CI around the observed ratio of geometric mean titers between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.|
1665125|NCT01466387|3063665|Non-Inferiority or Equivalence|GMC TF+YF+MenACWY-CRM/GMC TF+YF.|Ratio of GMC|1.14|||||2-Sided|95.0|0.81|1.6||||||The primary criterion for immunogenicity (postvaccination, day 29) was that the lower limit of the two-sided 95% confidence interval around the observed ratio of geometric mean concentrations between one dose of typhoid Vi polysaccharide and yellow fever vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone was greater than 0.5.|
1665126|NCT01466361|3063668|Superiority or Other||Least square mean difference|-9.7||||0.0547|2-Sided|95.0|-19.59|0.2|||ANCOVA||Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 3 minutes post dosing.|
1665127|NCT01466361|3063668|Superiority or Other||Least square mean difference|-3.58||||0.3922|2-Sided|95.0|-11.85|4.7|||ANCOVA||Treatment comparisons were made between 4mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, at 1 minute post dosing.|
1665128|NCT01466361|3063669|Superiority or Other||Least square mean difference|-5.0||||0.3936|2-Sided|95.0|-16.6|6.59|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 15 minutes post dosing.|
1665129|NCT01466361|3063669|Superiority or Other||Least square mean difference|-5.11||||0.3491|2-Sided|95.0|-15.87|5.66|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings, 10 minutes post dosing.|
1665130|NCT01466361|3063669|Superiority or Other||Least square mean difference|-6.33||||0.2225|2-Sided|95.0|-16.56|3.9|||ANCOVA||Treatment comparisons were made between 1.5mg nicotine lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 5 minute post dosing.|
1665131|NCT01466361|3063669|Superiority or Other||Least square mean difference|-7.16||||0.1489|2-Sided|95.0|-16.93|2.61|||ANCOVA||Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 3 minute post dosing.|
1665132|NCT01466361|3063669|Superiority or Other||Least square mean difference|-7.23||||0.0643|2-Sided|95.0|-14.89|0.44|||ANCOVA||Treatment comparisons were made between nicotine 1.5mg lozenge and placebo lozenge at 5% significance level.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to provoked nicotine cravings at 1 minute post dosing.|
1665133|NCT01466348|3063679|Superiority or Other||Adjusted Mean Difference|6.5|||<|0.0001|2-Sided|95.0|4.5|8.4|||ANOVA|No baseline covariate adjustment was applied.|A positive difference favors the paracetamol/ caffeine treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.|
1665134|NCT01466348|3063680|Superiority or Other||Adjusted Mean Difference|3.6||||0.0008|2-Sided|95.0|1.5|5.6|||ANOVA|No baseline covariate adjustment was carried out.|A positive difference favors the paracetamol/ caffeine treatment.|Null hypothesis was no difference in treatments in the change from baseline in the number of valid responses from the RVIP.|
1665135|NCT01466153|3063713|Superiority or Other|||||||0.9527|||||||Log Rank||||
1665136|NCT01466153|3063715|Superiority or Other|||||||0.313|||||||Cochran-Mantel-Haenszel||||
1665137|NCT01466153|3063716|Superiority or Other|||||||0.3206|||||||Cochran-Mantel-Haenszel||||
1665138|NCT01466153|3063720|Superiority or Other|||||||0.4475|||||||Cochran-Mantel-Haenszel||||
1665139|NCT01466127|3063721|Superiority or Other|||||||0.28|||||||t-test, 2 sided||||
1665140|NCT01465763|3063767|Superiority or Other||Least Square Mean Difference|-1.9|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|-2.5|-1.4|||ANCOVA|||The change from Baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.|
1665141|NCT01465763|3063768|Superiority or Other||Least Square Mean Difference|-1.5|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|-1.9|-1.1|||Mixed-Effects Model|||At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.|
1665142|NCT01465763|3063768|Superiority or Other||Least Square Mean Difference|-1.1|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|-1.5|-0.7|||Mixed-Effects Model|||At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.|
1665143|NCT01465763|3063768|Superiority or Other||Least Square Mean Difference|-0.9|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|-1.3|-0.5|||Mixed-Effects Model|||At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and participants as a random effect.|
1665144|NCT01465763|3063770|Superiority or Other||Percent Difference|6.5||||0.0043|2-Sided|95.0|4.3|8.7|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665145|NCT01465763|3063771|Superiority or Other||Percent Difference|6.0||||0.0601|2-Sided|95.0|1.0|11.1|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665199|NCT01462942|3064064|Superiority or Other||Least Squares Mean Difference|0.125|||<|0.0001|2-Sided|95.0|0.09|0.16|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors|||
1665146|NCT01465763|3063772|Superiority or Other||Percent Difference|10.3||||0.007|2-Sided|95.0|4.3|16.3|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665147|NCT01465763|3063773|Superiority or Other||Percent Difference|5.1||||0.0345|2-Sided|95.0|1.9|8.3|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665148|NCT01465763|3063774|Superiority or Other||Percent Difference|27.1|||<|0.0001|2-Sided|95.0|17.7|36.5|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665149|NCT01465763|3063775|Superiority or Other||Percent Difference|15.7||||0.0005|2-Sided|95.0|8.1|23.4|||CMH Chi-square test|||P-value based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665150|NCT01465763|3063776|Superiority or Other||Percent Difference|10.3||||0.007|2-Sided|95.0|4.3|16.3|||CMH Chi-square test|||P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).|
1665151|NCT01465464|3063778|Superiority||Hazard Ratio (HR)|1.09||||0.435|2-Sided|95.0|0.878|1.352|||Log Rank||||
1665152|NCT01465412|3063779|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|2.231|||||2-Sided|90.0|0.844|5.896||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.|
1665153|NCT01465412|3063779|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|1.609|||||2-Sided|90.0|1.007|2.572||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.|
1665154|NCT01465412|3063780|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|4.041|||||2-Sided|90.0|1.46|11.187||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.|
1665155|NCT01465412|3063780|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|1.326|||||2-Sided|90.0|0.749|2.348||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.|
1665156|NCT01465412|3063781|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|1.98|||||2-Sided|90.0|1.316|2.977||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.|
1665157|NCT01465412|3063781|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|1.269|||||2-Sided|90.0|0.703|2.288||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.|
1665158|NCT01465412|3063782|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|4.806|||||2-Sided|90.0|2.77|8.335||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.|
1665159|NCT01465412|3063782|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|1.555|||||2-Sided|90.0|0.617|3.917||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.|
1665160|NCT01465412|3063783|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|1.407|||||2-Sided|90.0|0.72|2.75||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.|
1665161|NCT01465412|3063783|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|1.548|||||2-Sided|90.0|0.918|2.61||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.|
1665162|NCT01465412|3063784|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|2.392|||||2-Sided|90.0|1.306|4.382||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.|
1665163|NCT01465412|3063784|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|1.852|||||2-Sided|90.0|0.81|4.234||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.|
1665164|NCT01465412|3063785|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|1.434|||||2-Sided|90.0|0.643|3.198||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.|
1665165|NCT01465412|3063785|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|1.305|||||2-Sided|90.0|0.84|2.027||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was excluded from Part 1 analysis.|
1665166|NCT01465412|3063786|Non-Inferiority or Equivalence|To be considered equivalent the LSM Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|2.598|||||2-Sided|90.0|1.334|5.06||||||The analysis was performed using an ANCOVA model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, BMI and a categorical covariate, gender. Gender was included from Part 2 analysis.|
1665167|NCT01465412|3063786|Non-Inferiority or Equivalence|To be considered equivalent the least squares mean (LSM) Ratio (HI/Healthy) is contained within the interval [0.50, 2.00].|LSM Ratio|1.075|||||2-Sided|90.0|0.695|1.662||||||The analysis was performed using an analysis of covariance (ANCOVA) model. Parameters were log-transformed (using the natural logarithm) prior to analysis. Study population (i.e., HI or Healthy) was included as a fixed effect with continuous covariates age, Body Mass Index (BMI) and a categorical covariate, gender. Gender was excluded from Part 1 analysis.|
1665168|NCT01464827|3063850|Superiority or Other||Odds Ratio (OR)|1.41||||0.616|2-Sided|95.0|0.37|5.34||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Groups [F + G + H + I] : Groups [K + L + M + N]|The percentage of participants with SVR24 after treatment with 3 DAAs and ribavirin in treatment-naïve versus null-responders was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose as predictors.|
1665169|NCT01464827|3063851|Superiority or Other||Difference|-7.13||||0.106|2-Sided|95.0|-15.77|1.51||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Group E - Groups [F + G + K + L]|The percentage of participants with SVR24 after treatment with 3 DAAs with and without ribavirin was compared using a stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).|
1665170|NCT01464827|3063852|Superiority or Other||Difference|-6.75||||0.065|2-Sided|95.0|-13.93|0.43||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Groups [C + D + J] - Groups [F + G + K + L]|The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).|
1665171|NCT01464827|3063852|Superiority or Other||Difference|-12.16||||0.068|2-Sided|95.0|-25.2|0.88||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Mantel Haenszel|The Mantel-Haenszel method was used because logistic regression failed due to separation or quasi-separation.|Difference = Group B - Groups [F + G + K + L]|The percentage of participants with SVR24 after treatment with 2 DAAs and ribavirin versus 3 DAAs and ribavirin was compared using stratum-adjusted Mantel-Haenszel (MH) method with Interleukin 28B genotype (CC or non-CC) and HCV subgenotype (1a or non-1a).|
1665172|NCT01464827|3063853|Superiority or Other||Odds Ratio (OR)|1.64||||0.375|2-Sided|95.0|0.55|4.92||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Groups [F + G + K + L] : Groups [H + I + M + N]|The percentage of participants with SVR24 after treatment for 12 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.|
1665173|NCT01464827|3063853|Superiority or Other||Odds Ratio (OR)|0.66||||0.525|2-Sided|95.0|0.18|2.4||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Groups [H + I + M + N]|The percentage of participants with SVR24 after treatment for 8 weeks versus 24 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.|
1665200|NCT01462435|3064098|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1665201|NCT01462435|3064098|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1665202|NCT01462435|3064098|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1665203|NCT01462435|3064099|Superiority or Other|||||||0.004|||||||t-test, 2 sided||||
1665204|NCT01462435|3064099|Superiority or Other|||||||0.005|||||||t-test, 2 sided||||
1665174|NCT01464827|3063853|Superiority or Other||Odds Ratio (OR)|0.4||||0.266|2-Sided|95.0|0.08|2.02||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Groups [F + G + K + L]|The percentage of participants with SVR24 after treatment for 8 weeks versus 12 weeks was compared using logistic regression with treatment group, baseline log10 HCV RNA level, HCV subgenotype (1a or non-1a), geographic region (US or non-US), Interleukin 28B genotype (CC or non-CC), and ABT-450/ritonavir dose and population (treatment-naïve or null-responders) as predictors.|
1665175|NCT01464827|3063854|Superiority or Other||Odds Ratio (OR)|0.49||||0.406|2-Sided|95.0|0.09|2.61||No adjustment for multiple comparison. Pre-specified 2-sided significance level of 0.05.|Regression, Logistic||Odds ratio: Group A : Group G|"The primary efficacy endpoint was the comparison of the percentage of treatment-naïve participants with SVR24 after treatment with 3 DAAs (at the 150 mg ABT-450 dose) and ribavirin for 8 weeks (Group A) versus 12 weeks (Group G).~Logistic regression with baseline log10 HCV RNA level, treatment group, Interleukin 28B genotype (CC or non-CC), HCV subgenotype (1a or non-1a), and geographic region (US or non-US) as predictors."|
1665176|NCT01464346|3063912|Superiority or Other||Intercept from ANCOVA as agreement rate|90.52|Standard Error of the Mean|0.9|<|0.05|2-Sided|95.0|88.77|92.28|||ANCOVA|Mixed effects model was used, with day of sensor wear(1,3 or 6) as covariate. Day was centered to 0 to permit interpretation of the model intercept|||
1665177|NCT01464346|3063913|Superiority or Other||Intercept from ANCOVA as agreement rate|88.01|Standard Error of the Mean|1.2|<|0.05|2-Sided|95.0|85.69|90.33|||ANCOVA|Mixed effects model was used, with day of sensor wear(1,3 or 6) as covariate. Day was centered to 0 to permit interpretation of the model intercept|||
1665178|NCT01464307|3063923|Superiority or Other||Odds Ratio (OR)|1.14||||0.698|2-Sided|95.0|0.59|2.21||observed cases analysis.|Regression, Logistic|||Week 12. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=273 for week 12.|
1665179|NCT01464307|3063923|Superiority or Other||Odds Ratio (OR)|1.23||||0.437|2-Sided|95.0|0.73|2.04||observed cases analysis.|Regression, Logistic|||Week 8. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=279 for week 8.|
1665180|NCT01464307|3063923|Superiority or Other||Odds Ratio (OR)|1.05||||0.845|2-Sided|95.0|0.63|1.74||observed cases analysis.|Regression, Logistic|||Week 4. Number of subjects included in analysis was three less than the observed cases because of a missing covariate for the logistic regression analysis, that is, n=283 for week 4.|
1665181|NCT01464307|3063924|Superiority or Other|||||||0.804||||||worst-case analysis.|Wilcoxon's Rank-Sum Test|||The statistical analysis provided was for all categories of this outcome measure.|
1665182|NCT01464307|3063925|Superiority or Other||Least Square Mean Difference|0.0||||0.777|2-Sided|95.0|-0.1|0.2|||Mixed-Model Repeated Measures|||The number of subjects included in the MMRM analysis was only 286 because a covariate was missing for 3 subjects.|
1665183|NCT01463683|3063961|Superiority or Other||Difference in percentage of participants|-0.9||||0.686|2-Sided|95.0|-7.1|3.0|||Miettinen & Nurminen||||
1665184|NCT01463683|3063961|Superiority or Other||Difference in percentage of participants|-1.6||||0.459|2-Sided|95.0|-7.7|2.2|||Miettinen & Nurminen||||
1665185|NCT01463683|3063961|Superiority or Other||Difference in percentage of participants|-0.7||||0.659|2-Sided|95.0|-3.8|2.4|||Miettinen & Nurminen||||
1665186|NCT01463683|3063962|Superiority or Other||Difference in percentage of participants|6.0||||0.246|2-Sided|95.0|-4.0|16.8|||Miettinen & Nurminen||||
1665187|NCT01463683|3063962|Superiority or Other||Difference in percentage of participants|11.0||||0.028|2-Sided|95.0|1.1|21.6|||Miettinen & Nurminen||||
1665188|NCT01463683|3063962|Superiority or Other||Difference in percentage of participants|4.9||||0.162|2-Sided|95.0|-2.0|11.9|||Miettinen & Nurminen||||
1665189|NCT01463683|3063963|Non-Inferiority or Equivalence|Incidence of seroprotection with V232-2XP SC is non-inferior to V232-1XP SC if the lower bound of the 95% confidence interval of the difference is greater than -10%|Difference in percentage of participants|7.6|||||2-Sided|95.0|1.9|13.6|||||||
1665190|NCT01463527|3063969|Superiority|||||||0.3|||||||GEE (Generalized Estimating Equation)||||
1665191|NCT01463527|3063970|Superiority or Other||Odds Ratio (OR)|0.31|||||2-Sided|95.0|0.17|0.57||||||Odds of intervention in capnography open group as compared to capnography blind group after adjusting of age and length of sedation.|
1665192|NCT01462942|3064061|Superiority or Other||Least squares mean difference|-1.828||||0.1406|2-Sided|95.0|-4.259|0.604|||Mixed Models Analysis|Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors|||
1665193|NCT01462942|3064061|Superiority or Other||Least squares mean difference|-0.653||||0.598|2-Sided|95.0|-3.082|1.776|||Mixed Models Analysis|Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors|||
1665194|NCT01462942|3064062|Superiority or Other||Least Squares Mean Difference|1.162|||<|0.0001|2-Sided|95.0|0.593|1.73|||Mixed Models Analysis|||Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors|
1665195|NCT01462942|3064062|Superiority or Other||Least squares mean difference|1.293|||<|0.0001|2-Sided|95.0|0.728|1.859|||Mixed Models Analysis|Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors|||
1665196|NCT01462942|3064063|Superiority or Other||Least Squares Mean Difference|0.053||||0.0022|2-Sided|95.0|0.019|0.087|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors|||
1665197|NCT01462942|3064063|Superiority or Other||Least Squares Mean Difference|0.085|||<|0.0001|2-Sided|95.0|0.051|0.119|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors|||
1665198|NCT01462942|3064064|Superiority or Other||Least Squares Mean Difference|0.069||||0.0001|2-Sided|95.0|0.034|0.105|||Mixed Models Analysis|Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors|||
1665215|NCT01462435|3064103|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1665216|NCT01462435|3064103|Superiority or Other|||||||0.029|||||||t-test, 2 sided||||
1665217|NCT01462435|3064103|Superiority or Other|||||||0.009|||||||t-test, 2 sided||||
1665218|NCT01462435|3064104|Superiority or Other|||||||0.183|||||||t-test, 2 sided||||
1665219|NCT01462435|3064104|Superiority or Other|||||||0.109|||||||t-test, 2 sided||||
1665220|NCT01462435|3064104|Superiority or Other|||||||0.043|||||||t-test, 2 sided||||
1665221|NCT01462435|3064105|Superiority or Other||Difference in Least Squares Mean|313.119|Standard Error of the Mean|122.5676||0.011|2-Sided|95.0|72.202|554.037|||ANCOVA||||
1665222|NCT01462435|3064105|Superiority or Other||Difference in Least Squares Mean|316.145|Standard Error of the Mean|121.5971||0.01|2-Sided|95.0|77.136|555.155|||ANCOVA||||
1665223|NCT01462435|3064105|Superiority or Other||Difference in Least Squares Mean|446.946|Standard Error of the Mean|122.2935|<|0.001|2-Sided|95.0|206.567|687.324|||ANCOVA||||
1665224|NCT01462370|3064106|Superiority or Other||Odds Ratio (OR)|1.97||||0.019|2-Sided|95.0|1.12|3.45||A priori threshold for statistical significance = <0.05.|Regression, Logistic|Adjusted for treatment, period, and baseline pain intensity.|||
1665225|NCT01462370|3064107|Superiority or Other||Odds Ratio (OR)|1.6||||0.112|2-Sided|95.0|0.9|2.87||A priori threshold for statistical significance = <0.05.|Regression, Logistic|Adjusted for treatment, period, and baseline pain intensity.|||
1665226|NCT01462370|3064108|Superiority or Other||Difference in LS Means|0.26||||0.004|2-Sided|95.0|0.08|0.44||A priori threshold for statistical significance = <0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).|||
1665227|NCT01462370|3064109|Superiority or Other||Difference in LS Means|0.11||||0.011|2-Sided|95.0|0.03|0.2||A priori threshold for statistical significance = <0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).|||
1665228|NCT01462370|3064110|Superiority or Other||Difference in LS Means|0.28||||0.002|2-Sided|95.0|0.1|0.45||A priori threshold for statistical significance = <0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).|||
1665229|NCT01462370|3064111|Superiority or Other||Difference in LS Means|0.21|||<|0.001|2-Sided|95.0|0.1|0.31||A priori threshold for statistical significance = <0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).|||
1665230|NCT01462370|3064113|Superiority or Other||Mean Difference in LS Means|0.17||||0.019|2-Sided|95.0|0.03|0.32||A priori threshold for statistical significance = <0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).|||
1665231|NCT01462370|3064114|Superiority or Other||Difference in LS Means|0.1||||0.051|2-Sided|95.0|0.0|0.2||A priori threshold for statistical significance = <0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).|||
1665232|NCT01462370|3064115|Superiority or Other||Odds Ratio (OR)|0.89||||0.371|2-Sided|95.0|0.7|1.14||A priori threshold for statistical significance = <0.05.|Regression, Cox|Adjusted for treatment, period, and baseline pain intensity.|||
1665233|NCT01462370|3064116|Superiority or Other||Difference in LS Means|0.36|||<|0.001|2-Sided|95.0|0.17|0.54||A nominal threshold for statistical significance = <0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).|||
1665234|NCT01462370|3064117|Superiority or Other||Difference in LS Means|0.26||||0.007|2-Sided|95.0|0.07|0.45||A nominal threshold for statistical significance = <0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).|||
1665235|NCT01462370|3064118|Superiority or Other||Difference in LS Means|0.2||||0.768|2-Sided|95.0|-1.16|1.57||A nominal threshold for statistical significance = <0.05.|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).|||
1665236|NCT01462370|3064119|Non-Inferiority or Equivalence|The noninferiority margin is -3.7 units.|Difference in LS Means|0.89||||0.043|2-Sided|95.0|0.03|1.76||A priori threshold for statistical significance = <0.025 (one-sided).|ANOVA|Adjusted for treatment, period, sequence, patient (sequence), and baseline pain intensity (moderate or severe).||With at least 128 participants, the study had a 92% power to establish that etoricoxib is noninferior to ibuprofen (null hypothesis). The power and sample size were based on the following assumptions: 1) an approximately 15% protocol violation rate, 2) a noninferiority margin of -3.7 units (etoricoxib minus ibuprofen), and 3) an intrapatient standard deviation of 8 units.|
1665237|NCT01462357|3064139|Superiority|Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-16 antibodies.|GMT ratio|1.69||||0.0001|2-Sided|95.0|1.49|1.91|||ANOVA|||Anti-HPV-16 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.|
1665238|NCT01462357|3064139|Superiority|Superiority was shown if the lower limit of the 95% CI for the ratio of GMTs (Cervarix 2 dose Group divided by Gardasil 2 dose Group) was above 1 for anti-HPV-18 antibodies.|GMT ratio|4.52||||0.0001|2-Sided|95.0|3.97|5.13|||ANOVA|||Anti-HPV-18 immune response: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is superior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, in 9-14 year-old females, 1 month after the last dose (Month 7) regardless of serostatus.|
1665239|NCT01462357|3064140|Non-Inferiority|Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.|GMT ratio|0.23|||||2-Sided|95.0|0.2|0.26||||||Immune response to anti-HPV-18 in terms of GMT: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.|
1667980|NCT01416636|3069725|Superiority|||||||0.032|||||||Wilcoxon (Mann-Whitney)||||
1665240|NCT01462357|3064140|Non-Inferiority|Non-inferiority with respect to GMT was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% CI for the GMT ratio (Gardasil 2 dose Group divided by Cervarix 2 dose Group) was below 2.|GMT ratio|0.61|||||2-Sided|95.0|0.54|0.69||||||Immune response to anti-HPV-16 in terms of Geometric Mean Titers (GMT): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.|
1665241|NCT01462357|3064141|Non-Inferiority|Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.|Difference in SCR|0.0|||||2-Sided|95.0|-1.15|1.14||||||Immune response to anti-HPV-18 in terms of SCR: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.|
1665242|NCT01462357|3064141|Non-Inferiority|Non-inferiority with respect to seroconversion was shown if, one month after the last dose, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference (Gardasil 2 dose Group minus Cervarix 2 dose Group) was below 5%.|Difference in SCR|0.0|||||2-Sided|95.0|-1.16|1.15||||||Immune response to anti-HPV-16 in terms of seroconversion rates (SCR): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months is non-inferior to that of Gardasil vaccine administered according to a 2-dose schedule at 0, 6 months, 1 month after the last dose (Month 7), in initially seronegative subjects.|
1665243|NCT01462344|3064148|Superiority or Other||Hazard Ratio (HR)|0.859|||||2-Sided|95.0|0.729|1.012|||||Estimated for Hazard ratio||
1665244|NCT01462344|3064149|Superiority or Other||Risk Difference (RD)|0.0019|||||2-Sided|95.0|-0.0024|0.0063|||||Estimated for Absolute risk difference||
1665245|NCT01462344|3064149|Non-Inferiority or Equivalence|The non-inferiority comparison was statistically significant if the upper bound of the two-sided 95% CI falls below 2.675, the non-inferiority margin, and the non-inferiority test one-sided p-value <0.025.|Hazard Ratio (HR)|1.285||||0.006|2-Sided|95.0|0.726|2.272|||Regression, Cox||Estimated for Hazard ratio||
1665246|NCT01462318|3064150|Superiority or Other||ratio|0.878|||||2-Sided|90.0|0.697|1.105|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.|
1665247|NCT01462318|3064152|Superiority or Other||ratio|1.116|||||2-Sided|90.0|1.005|1.238|||||test/reference = caffeine+DAC HYP/caffeine|Pairwise comparison: caffeine. Based on linear mixed model with fixed effect for treatment and random effect for participants. Excludes participants with high predose concentration (>5% of Cmax).|
1665248|NCT01462318|3064152|Superiority or Other||ratio|1.058|||||2-Sided|90.0|0.804|1.392|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.|
1665249|NCT01462318|3064152|Superiority or Other||ratio|1.012|||||2-Sided|90.0|0.952|1.075|||||test/reference = S-warfarin+DAC HYP/S-warfarin|Pairwise comparison: S-warfarin. Based on linear mixed model with fixed effect for treatment and random effect for participants.|
1665250|NCT01462318|3064152|Superiority or Other||ratio|1.079|||||2-Sided|90.0|0.912|1.276|||||test/reference = midazolam+DAC HYP/midazolam|Pairwise comparison: midazolam. Based on linear mixed model with fixed effect for treatment and random effect for participants.|
1665251|NCT01462318|3064160|Superiority or Other||ratio|1.012|||||2-Sided|90.0|0.764|1.342|||||test/reference = dextromethorphan+DAC HYP/dextromethorphan|Pairwise comparison: dextromethorphan. Based on linear mixed model with fixed effect for treatment and random effect for participants.|
1665252|NCT01462318|3064161|Superiority or Other||ratio|1.032|||||2-Sided|90.0|0.93|1.145|||||test/reference = caffeine+DAC HYP/caffeine|Pairwise comparison: caffeine. Based on linear mixed model with fixed effect for treatment and random effect for participants. Excludes participants with high predose concentration (>5% of maximum observed concentration [Cmax]).|
1665253|NCT01462318|3064161|Superiority or Other||ratio|0.996|||||2-Sided|90.0|0.88|1.127|||||test/reference = omeprazole+DAC HYP/omeprazole|Pairwise comparison: omeprazole. Based on linear mixed model with fixed effect for treatment and random effect for participants.|
1665254|NCT01462318|3064161|Superiority or Other||ratio|1.005|||||2-Sided|90.0|0.951|1.063|||||test/reference = S-warfarin+DAC HYP/S-warfarin|Pairwise comparison: S-warfarin. Based on linear mixed model with fixed effect for treatment and random effect for participants.|
1665255|NCT01462318|3064161|Superiority or Other||ratio|1.015|||||2-Sided|90.0|0.894|1.153|||||test/reference = midazolam+DAC HYP/midazolam|Pairwise comparison: midazolam. Based on linear mixed model with fixed effect for treatment and random effect for participants.|
1665256|NCT01462305|3064164|Superiority or Other|||||||0.2|||||||ANOVA||||
1665257|NCT01462305|3064166|Superiority or Other||||||<|0.0001||||||A repeated-measures ANOVA on the 29 subjects revealed significant effect of treatment week|ANOVA||||
1665258|NCT01462305|3064166|Superiority or Other||||||<|0.9||||||A repeated-measures ANOVA on the 29 subjects revealed no significant effect or interaction effect|ANOVA||||
1665259|NCT01462305|3064166|Superiority or Other||||||<|0.74||||||interaction effect and week of treatment condition|ANOVA|||To test the hypothesis that depressed SAD patients would demonstrate greater antidepressant therapeutic benefit from the ~465nm (shorter wavelength) source compared with the ~595nm (longer wavelength) source, we conducted a repeated-measures ANOVA using PROC MIXED in SAS 9.3 with treatment (~465nm vs. ~595nm) as a between-subject factor and time (treatment visit 1, treatment visit 2, treatment visit 3, phone assessment 1, phone assessment 2, and treatment visit 4) as a within-subject factor.|
1665260|NCT01462292|3064169|Superiority or Other||Odds Ratio (OR)|0.36||||0.417|2-Sided|95.0|0.03|4.27||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Regression, Logistic|Model includes terms for Treatment and Centre Grouping||Placebo (combined), GSK2402968 6 mg/kg/week|
1665323|NCT01462162|3064220|Superiority or Other|||||||0.348|||||||Regression, Linear|||change in hemoglobin levels versus change in swollen joint count (Week 24)|
1665261|NCT01462292|3064169|Superiority or Other||Odds Ratio (OR)|0.41||||0.541|2-Sided|95.0|0.02|7.01||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Regression, Logistic|Model includes terms for Treatment and Centre Grouping||Placebo (combined), GSK2402968 3 mg/kg/week|
1665262|NCT01462292|3064176|Superiority or Other||Mean Difference (Net)|167.39||||0.921|2-Sided|95.0|-3208.98|3543.77||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg, Week 48|
1665263|NCT01462292|3064176|Superiority or Other||Mean Difference (Net)|-1305.46||||0.439|2-Sided|95.0|-4668.41|2057.48||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg, Week 24|
1665264|NCT01462292|3064176|Superiority or Other||Mean Difference (Net)|-2054.86||||0.248|2-Sided|95.0|-5587.33|1477.6||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg, Week 48|
1665265|NCT01462292|3064176|Superiority or Other||Mean Difference (Net)|-892.88||||0.61|2-Sided|95.0|-4391.1|2605.35||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, center grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg, Week 24|
1665266|NCT01462292|3064178|Superiority or Other||Mean Difference (Net)|-0.18||||0.873|2-Sided|95.0|-2.49|2.12||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg|
1665267|NCT01462292|3064178|Superiority or Other||Mean Difference (Net)|-0.49||||0.684|2-Sided|95.0|-2.9|1.92||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg|
1665268|NCT01462292|3064180|Superiority or Other||Mean Difference (Net)|0.821||||0.898|2-Sided|95.0|-12.034|13.676||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model includes terms for Treatment, Centre Grouping and Baseline Muscle Strength Total Score||Treatment difference: Placebo Vs GSK2402968 6mg|
1665269|NCT01462292|3064180|Superiority or Other||Mean Difference (Net)|2.356||||0.723|2-Sided|95.0|-10.936|15.648||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model includes terms for Treatment, Centre Grouping and Baseline Muscle Strength Total Score||Treatment difference: Placebo Vs GSK2402968 3 mg|
1665270|NCT01462292|3064181|Superiority or Other||Mean Difference (Net)|0.037||||0.89|2-Sided|95.0|-0.498|0.571||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, center grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg|
1665271|NCT01462292|3064181|Superiority or Other||Median Difference (Net)|0.564||||0.05|2-Sided|95.0|0.0|1.127||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg|
1665272|NCT01462292|3064182|Superiority or Other||Mean Difference (Net)|-0.412||||0.523|2-Sided|95.0|-1.702|0.878||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 6 mg/kg/week, Descent Week 24|
1665273|NCT01462292|3064182|Superiority or Other||Mean Difference (Net)|-0.685||||0.311|2-Sided|95.0|-2.033|0.662||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 3 mg/kg/week, Descent Week 24|
1665274|NCT01462292|3064182|Superiority or Other||Mean Difference (Net)|-0.803||||0.064|2-Sided|95.0|-1.655|0.048||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Placebo (combined) Vs GSK2402968 6 mg/kg/week, Ascent, Week 24|
1665275|NCT01462292|3064182|Superiority or Other||Mean Difference (Net)|0.002||||0.997|2-Sided|95.0|-0.883|0.886||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment,centre grouping and baseline||Placebo (combined) Vs GSK2402968 3 mg/kg/week, Ascent Week 24|
1665276|NCT01462292|3064183|Superiority or Other||Mean Difference (Net)|0.831||||0.384|2-Sided|95.0|-1.072|2.735||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 6 mg|
1665277|NCT01462292|3064183|Superiority or Other||Mean Difference (Net)|0.387||||0.699|2-Sided|95.0|-1.618|2.392||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance|ANCOVA|Model included terms for treatment, centre grouping and baseline||Treatment difference: Placebo Vs GSK2402968 3 mg|
1665278|NCT01462292|3064184|Superiority or Other||Mean Difference (Net)|27.099||||0.069|2-Sided|95.0|-2.21|56.408||Due to the two comparisons for the two different doses, the type 1 error rate (5% overall) was preserved by utilising a hierarchical approach, testing the 6mg/kg GSK2402968 dose first|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, centre grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 6 mg|
1665324|NCT01462162|3064220|Superiority or Other|||||||0.678|||||||Regression, Linear|||change in hemoglobin levels versus change in swollen joint count (Week 12)|
1667981|NCT01416636|3069726|Superiority|||||||0.557|||||||Wilcoxon (Mann-Whitney)||||
1665279|NCT01462292|3064184|Superiority or Other||Mean Difference (Net)|-8.946||||0.554|2-Sided|95.0|-39.122|21.229||Due to the two comparisons for the two different doses, the type 1 error rate (5% overall) was preserved by utilizing a hierarchical approach, testing the 6mg/kg GSK2402968 dose first|Mixed Model Repeated Measures|Model included terms for treatment, visit, treatment by visit, centre grouping, baseline and baseline by visit||Treatment difference: Placebo Vs GSK2402968 3 mg|
1665280|NCT01462266|3064191|Superiority or Other||Mean Difference (Final Values)|-4.7||||0.009|2-Sided|95.0|-8.3|-1.2|||Longitudinal data analysis|Adjusting for participant's use of metformin at Visit 1/Screening Visit (i.e., on metformin, or not on metformin)|||
1665281|NCT01462162|3064207|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24|
1665282|NCT01462162|3064207|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12|
1665283|NCT01462162|3064208|Superiority or Other||||||<|0.005|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24|
1665284|NCT01462162|3064208|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12|
1665285|NCT01462162|3064209|Superiority or Other||||||<|0.005|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24|
1665286|NCT01462162|3064209|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12|
1665287|NCT01462162|3064210|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 24|
1665288|NCT01462162|3064210|Superiority or Other||||||<|0.162|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12|
1665289|NCT01462162|3064211|Superiority or Other||||||<|0.05|||||||Regression, Logistic|||Baseline for Week 24 versus Week 24|
1665290|NCT01462162|3064211|Superiority or Other||||||<|0.172|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12|
1665291|NCT01462162|3064212|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24|
1665292|NCT01462162|3064212|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12|
1665293|NCT01462162|3064213|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24|
1665294|NCT01462162|3064213|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12|
1665295|NCT01462162|3064214|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24|
1665296|NCT01462162|3064214|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12|
1665297|NCT01462162|3064215|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24|
1665298|NCT01462162|3064215|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12|
1665299|NCT01462162|3064216|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24|
1665300|NCT01462162|3064216|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12|
1665301|NCT01462162|3064217|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24|
1665302|NCT01462162|3064217|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12|
1665303|NCT01462162|3064218|Superiority or Other|||||||0.961|||||||Multiple Regression|||change in hemoglobin levels versus change in swollen joint count (Week 24)|
1665304|NCT01462162|3064218|Superiority or Other|||||||0.077|||||||Multiple Regression|||change in hemoglobin levels versus change in swollen joint count (Week 12)|
1665305|NCT01462162|3064219|Superiority or Other|||||||0.09|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 24)|
1665306|NCT01462162|3064219|Superiority or Other|||||||0.098|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 12)|
1665307|NCT01462162|3064219|Superiority or Other|||||||0.075|||||||Regression, Linear|||change in hemoglobin levels versus change in sleepiness (Week 24)|
1665308|NCT01462162|3064219|Superiority or Other|||||||0.936|||||||Regression, Linear|||change in hemoglobin levels versus change in sleepiness (Week 12)|
1665309|NCT01462162|3064219|Superiority or Other|||||||0.75|||||||Regression, Cox|||change in hemoglobin levels versus change in degree of pain (Week 24)|
1665310|NCT01462162|3064219|Superiority or Other|||||||0.65|||||||Regression, Linear|||change in hemoglobin levels versus change in degree of pain (Week 12)|
1665311|NCT01462162|3064219|Superiority or Other|||||||0.498|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 24)|
1665312|NCT01462162|3064219|Superiority or Other|||||||0.644|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 12)|
1665313|NCT01462162|3064219|Superiority or Other|||||||0.487|||||||Regression, Linear|||change in haemoglobin levels versus change in swollen joint count (Week 24)|
1665314|NCT01462162|3064219|Superiority or Other|||||||0.257|||||||Regression, Linear|||change in haemoglobin levels versus change in swollen joint count (Week 12)|
1665315|NCT01462162|3064220|Superiority or Other|||||||0.61|||||||Regression, Linear|||change in hemoglobin levels versus change in depression score (Week 24)|
1665316|NCT01462162|3064220|Superiority or Other|||||||0.249|||||||Regression, Linear|||change in haemoglobin levels versus change in depression score (Week 12)|
1665317|NCT01462162|3064220|Superiority or Other|||||||0.139|||||||Regression, Linear|||change in haemoglobin levels versus change in sleepiness (Week 24)|
1665318|NCT01462162|3064220|Superiority or Other|||||||0.878|||||||Regression, Linear|||change in haemoglobin levels versus change in sleepiness (Week 12)|
1665319|NCT01462162|3064220|Superiority or Other|||||||0.771|||||||Regression, Linear|||change in haemoglobin levels versus change in degree of pain (Week 24)|
1665320|NCT01462162|3064220|Superiority or Other|||||||0.692|||||||Regression, Linear|||change in haemoglobin levels versus change in degree of pain (Week 12)|
1665321|NCT01462162|3064220|Superiority or Other|||||||0.556|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 24)|
1665322|NCT01462162|3064220|Superiority or Other|||||||0.679|||||||Regression, Linear|||change in hemoglobin levels versus change in morning stiffness (Week 12)|
1665325|NCT01462162|3064221|Superiority or Other||||||<|0.001|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in depression at Week 24|
1665326|NCT01462162|3064221|Superiority or Other||||||<|0.001|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in depression Week 12|
1665327|NCT01462162|3064221|Superiority or Other||||||<|0.001|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in sleepiness at Week 24|
1665328|NCT01462162|3064221|Superiority or Other||||||<|0.003|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in sleepiness at Week 12|
1665329|NCT01462162|3064221|Superiority or Other||||||<|0.044|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in degree of pain Week 24|
1665330|NCT01462162|3064221|Superiority or Other||||||<|0.037|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in degree of pain Week 12|
1665331|NCT01462162|3064221|Superiority or Other||||||<|0.115|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in morning stiffness Week 24|
1665332|NCT01462162|3064221|Superiority or Other||||||<|0.163|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in morning stiffness Week 12|
1665333|NCT01462162|3064221|Superiority or Other||||||<|0.022|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in swollen joint count Week 24|
1665334|NCT01462162|3064221|Superiority or Other||||||<|0.182|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in swollen joint count Week 12|
1665335|NCT01462162|3064221|Superiority or Other||||||<|0.847|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in serum hemoglobin Week 24|
1665336|NCT01462162|3064221|Superiority or Other||||||<|0.791|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in serum hemoglobin Week 12|
1665337|NCT01462162|3064221|Superiority or Other||||||<|0.006|||||||Regression, Linear|||change in fatigue score at Week 24 versus change in DAS-28 at Week 24|
1665338|NCT01462162|3064221|Superiority or Other||||||<|0.003|||||||Regression, Linear|||change in fatigue score at Week 12 versus change in DAS-28 at Week 12|
1665339|NCT01462162|3064222|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 24 versus Week 24|
1665340|NCT01462162|3064222|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline for Week 12 versus Week 12|
1665341|NCT01462162|3064223|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline versus Week 24|
1665342|NCT01462162|3064223|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline versus Week 12|
1665343|NCT01462162|3064224|Superiority or Other|||||||0|||||||Regression, Linear|||change in fatigue score versus change in depression score|
1665344|NCT01462162|3064224|Superiority or Other|||||||0.007|||||||Regression, Linear|||change in fatigue score versus change in sleepiness score|
1665345|NCT01462162|3064224|Superiority or Other|||||||0.023|||||||Regression, Linear|||change in fatigue score versus change in DAS-28 score|
1665346|NCT01462162|3064225|Superiority or Other|||||||0|||||||Regression, Linear|||change in fatigue score versus change in depression score|
1665347|NCT01462162|3064225|Superiority or Other|||||||0|||||||Regression, Linear|||change in fatigue score versus change in sleepiness score|
1665348|NCT01462162|3064225|Superiority or Other|||||||0.006|||||||Regression, Linear|||change in fatigue score versus change in DAS-28 score|
1665349|NCT01462110|3064228|Superiority|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-0.06|Standard Error of the Mean|0.0087|<|0.001|2-Sided|95.0|-0.078|-0.043|||ANCOVA|Terms for treatment as a factor & baseline as a covariate.|||
1665350|NCT01462110|3064229|Superiority|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.044|Standard Error of the Mean|0.0076|<|0.001|2-Sided|95.0|-0.059|-0.029|||ANCOVA|Terms for treatment as a factor & baseline as a covariate.|||
1665351|NCT01462110|3064230|Superiority|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.83|Standard Error of the Mean|0.0957|<|0.001|2-Sided|95.0|-1.02|-0.639|||ANCOVA|Terms for treatment as a factor & baseline as a covariate.|||
1665352|NCT01462110|3064231|Superiority|The null hypothesis was the Week 2 mean is equal between the two cells. The alternative hypothesis was the Week 2 mean is not equal between the two cells.|Mean Difference (Net)|-0.106|Standard Error of the Mean|0.0173|<|0.001|2-Sided|95.0|-0.14|-0.071|||ANCOVA|Terms for treatment as a factor & baseline as a covariate.|||
1665353|NCT01462110|3064232|Superiority|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-1.232|Standard Error of the Mean|0.0806|<|0.001|2-Sided|95.0|-1.392|-1.071|||ANCOVA|Terms for treatment as a factor & baseline as a covariate.|||
1665354|NCT01462110|3064233|Superiority|The null hypothesis was the Week 4 mean is equal between the two cells. The alternative hypothesis was the Week 4 mean is not equal between the two cells.|Mean Difference (Net)|-0.234|Standard Error of the Mean|0.0211|<|0.001|2-Sided|95.0|-0.276|-0.192|||ANCOVA|Terms for treatment as a factor & baseline as a covariate.|||
1665355|NCT01462045|3064236|Superiority or Other||Mean Difference (Final Values)|5.8|Standard Error of the Mean|2.4|<|0.01|2-Sided|95.0|0.83|10.8|||t-test, 2 sided||||
1665356|NCT01462045|3064237|Superiority or Other||Mean Difference (Final Values)|-13.6|Standard Error of the Mean|5.7|<|0.01|2-Sided|95.0|-25.6|-1.6|||t-test, 2 sided||||
1665357|NCT01461993|3064244|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.92|||||2-Sided|95.0|0.84|1.01||||||PMB2948 [B24]|
1665358|NCT01461993|3064244|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.92|||||2-Sided|95.0|0.85|1.0||||||PMB80 [A22]|
1665359|NCT01461993|3064245|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.71|||||2-Sided|95.0|0.62|0.81||||||HPV-18|
1665360|NCT01461993|3064245|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.78|||||2-Sided|95.0|0.68|0.88||||||HPV-16|
1665361|NCT01461993|3064245|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.82|||||2-Sided|95.0|0.74|0.91||||||HPV-11|
1665362|NCT01461993|3064245|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold.|GMT Ratio|0.82||||||95.0|0.72|0.94||||||HPV-6|
1665363|NCT01461980|3064254|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.9|||||2-Sided|95.0|0.82|1.0||||||PMB2948 [B24]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).|
1665364|NCT01461980|3064254|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.92|||||2-Sided|95.0|0.84|1.02||||||PMB80 [A22]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).|
1665365|NCT01461980|3064255|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.93|||||2-Sided|95.0|0.83|1.04||||||Serogroup W-135: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup W-135 antigens).|
1665366|NCT01461980|3064255|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|0.99|||||2-Sided|95.0|0.89|1.09||||||Serogroup Y: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup Y antigens).|
1665367|NCT01461980|3064255|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.|GMT Ratio|1.02|||||2-Sided|95.0|0.9|1.15||||||Serogroup C: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup C antigens).|
1665368|NCT01461980|3064255|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67|GMT Ratio|0.91|||||2-Sided|95.0|0.82|1.01||||||Serogroup A: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup A antigens).|
1665369|NCT01461980|3064256|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.9|||||2-Sided|95.0|0.74|1.08||||||Pertussis fimbriae agglutinogens types 2 + 3: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis fimbriae agglutinogens types 2 + 3 antigens).|
1665370|NCT01461980|3064256|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.88|||||2-Sided|95.0|0.8|0.98||||||Pertussis pertactin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis pertactin antigens).|
1665371|NCT01461980|3064256|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.91|||||2-Sided|95.0|0.84|0.98||||||Pertussis filamentous hemagglutinin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis filamentous hemagglutinin antigens).|
1665372|NCT01461980|3064256|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.93|||||2-Sided|95.0|0.85|1.02||||||Pertussis toxoid: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Pertussis toxoid).|
1665373|NCT01461980|3064257|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.92|||||2-Sided|95.0|0.85|0.99||||||Tetanus: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Tetanus antigens).|
1665374|NCT01461980|3064257|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.|GMC Ratio|0.94|||||2-Sided|95.0|0.86|1.03||||||Diphtheria: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Diphtheria antigens).|
1665400|NCT01460407|3064428|Superiority or Other||Ratio of geometric LS mean|1.28|||||2-Sided|90.0|1.16|1.42|||||Ratio of LY2216684 and Clarithromycin to LY2216684||
1665401|NCT01460368|3064435|Superiority or Other||Least Squares Mean Difference|10.56|||||2-Sided|90.0|7.69|13.43|||||Treatment comparison at 4 hours.||
1665375|NCT01461928|3064266|Superiority||Hazard Ratio (HR)|0.76|||=|0|2-Sided|95.0|0.37|1.53||Power at time of final analysis was less than 40%. Final analysis was not able to address its primary objective.|Stratified Long-rank|||The stratified log rank test p-value was derived using the following randomization stratification strata : Follicular Lymphoma International Prognostic Index (FLIPI) risk category (low, intermediate, high) and indolent NHL subtype (follicular lymphoma, non-follicular lymphoma). Power at time of final analysis was less than 40%. Final analysis was not able to address it's primary objective.|
1665376|NCT01461668|3064287|Superiority||Odds Ratio (OR)|0.41||||0.32|2-Sided|95.0|0.08|1.86|||Fisher Exact||Confidence interval for the odds ratio is based upon the inversion Fisher's exact test||
1665377|NCT01461473|3064313|Superiority or Other|||||||0.1531|||||||see Comments|Analysis of covariance with robust MM regression due to extreme residuals from initial fit showing strong departure from normal distribution.||Using analysis of covariance (robust MM regression), the outcome was regressed on an indicator variable for PAP vs. OA, baseline outcome, baseline apnea-hypopnea index, gender, site, baseline brachial-artery diameter, body mass index, age, and the interaction of gender and study arm. The latter allows for the possibility that treatment effect may differ between males and females. A Wald statistic was constructed for hypothesis testing.|
1665378|NCT01461473|3064314|Superiority or Other|||||||0.3449|||||||see Comments|Analysis of covariance with robust MM regression due to extreme residuals from initial fit showing strong departure from normal distribution.||Using analysis of covariance (robust MM regression), the outcome was regressed on an indicator variable for PAP vs. OA, baseline outcome, baseline apnea-hypopnea index, gender, site, baseline brachial-artery diameter, body mass index, age, and the interaction of gender and study arm. The latter allows for the possibility that treatment effect may differ between males and females. A Wald statistic was constructed for hypothesis testing.|
1665379|NCT01461473|3064315|Superiority or Other|||||||0.3895|||||||GLMM|||A GLMM was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.|
1665380|NCT01461473|3064316|Superiority or Other|||||||0.9319|||||||GLMM|||A GLMM was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.|
1665381|NCT01461473|3064317|Superiority or Other|||||||0.3902|||||||GLMM|||Generalized linear mixed model (GLMM) was fit in which the outcome was regressed on an indicator variable for PAP vs. OA, baseline apnea-hypopnea index, gender, site and baseline value of the outcome. A Wald statistic was constructed for hypothesis testing.|
1665382|NCT01461473|3064318|Superiority or Other|||||||0.2067|||||||Analysis of covariance (GLM)|||These data were analyzed using an analysis of covariance via general linear model (GLM). The GLM has an indicator variable for PAP vs. OA plus covariates for baseline apnea-hypopnea index, gender, site and baseline NMAP. The primary hypothesis tested is that the 2-month means differ between study arms, after adjustment for the above covariates. A Wald statistic was constructed for hypothesis testing.|
1665383|NCT01461369|3064319|Superiority or Other||Difference in Least Squares Mean|-5.46|Standard Error of the Mean|3.385||0.1081|2-Sided|95.0|-12.13|1.21|||ANCOVA||||
1665384|NCT01461369|3064319|Superiority or Other||Difference in Least Squares Mean|-10.38|Standard Error of the Mean|3.441||0.0028|2-Sided|95.0|-17.16|-3.6|||ANCOVA||||
1665385|NCT01461369|3064320|Superiority or Other||Difference in Least Squares Mean|-7.03|Standard Error of the Mean|3.339||0.0363|2-Sided|95.0|-13.6|-0.45|||ANCOVA||||
1665386|NCT01461369|3064320|Superiority or Other||Difference in Least Squares Mean|-12.63|Standard Error of the Mean|3.396||0.0002|2-Sided|95.0|-19.32|-5.94|||ANCOVA||||
1665387|NCT01461369|3064321|Superiority or Other||Difference in Least Squares Mean|-7.48|Standard Error of the Mean|3.313||0.0248|2-Sided|95.0|-14.0|-0.96|||ANCOVA||||
1665388|NCT01461369|3064321|Superiority or Other||Difference in Least Squares Mean|-13.24|Standard Error of the Mean|3.377||0.0001|2-Sided|95.0|-19.89|-6.59|||ANCOVA||||
1665389|NCT01461369|3064322|Superiority or Other||Difference in Least Squares Mean|-5.56|Standard Error of the Mean|3.707||0.1349|2-Sided|95.0|-12.86|1.74|||Mixed Models Analysis||||
1665390|NCT01461369|3064322|Superiority or Other||Difference in Least Squares Mean|-12.43|Standard Error of the Mean|3.776||0.0011|2-Sided|95.0|-19.87|-4.99|||Mixed Models Analysis||||
1665391|NCT01461369|3064323|Superiority or Other||Difference in Least Squares Mean|-9.8|Standard Error of the Mean|3.481||0.0052|2-Sided|95.0|-16.66|-2.95|||Mixed Models Analysis||||
1665392|NCT01461369|3064323|Superiority or Other||Difference in Least Squares Mean|-15.82|Standard Error of the Mean|3.552|<|0.0001|2-Sided|95.0|-22.82|-8.83|||Mixed Models Analysis||||
1665393|NCT01461369|3064324|Superiority or Other||Difference in Least Squares Mean|-6.58|Standard Error of the Mean|3.739||0.0795|2-Sided|95.0|-13.94|0.78|||Mixed Models Analysis||||
1665394|NCT01461369|3064324|Superiority or Other||Difference in Least Squares Mean|-11.68|Standard Error of the Mean|3.806||0.0024|2-Sided|95.0|-19.17|-4.19|||Mixed Models Analysis||||
1665395|NCT01461096|3064329|Superiority or Other||Hazard Ratio (HR)|0.78||||0.35|2-Sided|95.1|0.47|1.31||P-value was unadjusted for multiple comparisons and a P-value less than 5% was the threshold for statistical significance.|generalized log-rank test (Sun 1996)|The generalized log-rank test (Sun 1996) was performed to evaluate whether participants in the two arms had the same survival rate.|qHPV group represented the numerator for the hazard ratio and Placebo group represented the denominator.||
1665396|NCT01460875|3064389|Non-Inferiority|The method to be developed will allow us to declare that a response at a lower dose is not inferior to that at the standard dose for a particular patient, using a patient specific inferiority test.||||||0.22|||||||Wilcoxon (Mann-Whitney)||||
1665397|NCT01460719|3064405|Other|The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the GMFR is >1.0.|||||<|0.001|||||||Single longitudinal regression model|Adjustments made for pre-vaccination values|||
1665398|NCT01460407|3064426|Superiority or Other||Median of paired differences|0.0||||0.7656|2-Sided|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)||LY2216684 and Clarithromycin minus (-) LY2216684||
1665399|NCT01460407|3064427|Superiority or Other||Ratio of geometric LS mean|1.21|||||2-Sided|90.0|1.12|1.31|||||Ratio of LY2216684 and Clarithromycin to LY2216684||
1667982|NCT01416636|3069727|Superiority|||||||0.0019|||||||Chi-squared||||
1665402|NCT01460368|3064435|Superiority or Other||Least Squares Mean Difference|8.07|||||2-Sided|90.0|5.21|10.94|||||Treatment comparison at 2 hours.||
1665403|NCT01460368|3064436|Superiority or Other||Least Squares Means Difference|3.63|||||2-Sided|90.0|1.63|5.63|||||Treatment comparison at 24 hours.||
1665404|NCT01460368|3064436|Superiority or Other||Least Squares Means Difference|-0.15|||||2-Sided|90.0|-2.14|1.85|||||Treatment comparison at 12 hours.||
1665405|NCT01460368|3064436|Superiority or Other||Least Squares Means Difference|9.08|||||2-Sided|90.0|7.1|11.07|||||Treatment comparison at 8 hours.||
1665406|NCT01460368|3064436|Superiority or Other||Least Squares Means Difference|9.14|||||2-Sided|90.0|7.12|11.16|||||Treatment comparison at 6 hours.||
1665407|NCT01460368|3064436|Superiority or Other||Least Squares Means Difference|3.69|||||2-Sided|90.0|1.67|5.71|||||Treatment comparison at 4 hours.||
1665408|NCT01460368|3064436|Superiority or Other||Least Squares Mean Difference|0.63|||||2-Sided|90.0|-1.38|2.63|||||Treatment comparison at 2 hours.||
1665409|NCT01460342|3064437|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.3||0.06|2-Sided|95.0|-1.2|0.0|||ANCOVA||||
1665410|NCT01460342|3064438|Superiority or Other||||||<|0.001||||||The p-value was from the Cochran-Mantel-Haenszel test adjusted for baseline severity of benign prostatic hyperplasia lower urinary tract symptoms (BPH-LUTS) and previous alpha-blocker therapy.|Cochran-Mantel-Haenszel||||
1665411|NCT01460342|3064439|Superiority or Other||||||<|0.001||||||The p-value was from the Cochran-Mantel-Haenszel test adjusted for baseline severity of benign prostatic hyperplasia lower urinary tract symptoms (BPH-LUTS) and previous alpha-blocker therapy.|Cochran-Mantel-Haenszel||||
1665412|NCT01460342|3064440|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.038|2-Sided|95.0|-0.4|0.0||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 12.|Mixed Models Analysis||||
1665413|NCT01460342|3064440|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.17|2-Sided|95.0|-0.3|0.1||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 8.|Mixed Models Analysis||||
1665414|NCT01460342|3064440|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.277|2-Sided|95.0|-0.2|0.1||The p-value was for the change from baseline in the IPSS QoL Index Score at Week 4.|Mixed Models Analysis||||
1665415|NCT01460342|3064441|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.3||0.002|2-Sided|95.0|-1.5|-0.3||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 12.|Mixed Models Analysis||||
1665416|NCT01460342|3064441|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.3||0.007|2-Sided|95.0|-1.3|-0.2||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 8.|Mixed Models Analysis||||
1665417|NCT01460342|3064441|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-1.5|-0.4||The p-value was for the change from baseline in the IPSS Voiding (Obstructive) Subscore at Week 4.|Mixed Models Analysis||||
1665418|NCT01460342|3064442|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.2||0.002|2-Sided|95.0|-0.9|-0.2||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 12.|Mixed Models Analysis||||
1665419|NCT01460342|3064442|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.2||0.011|2-Sided|95.0|-0.8|-0.1||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 8.|Mixed Models Analysis||||
1665420|NCT01460342|3064442|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.2||0.09|2-Sided|95.0|-0.6|0.0||The p-value was for the change from baseline in the IPSS Storage (Irritative) Subscore at Week 4.|Mixed Models Analysis||||
1665421|NCT01460342|3064443|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.4||0.003|2-Sided|95.0|-2.0|-0.4||The p-value is for the change from baseline in the IPSS Total Score at Week 8.|Mixed Models Analysis||||
1665422|NCT01460342|3064443|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-2.0|-0.5||The p-value is for the change from baseline in the IPSS Total Score at Week 4.|Mixed Models Analysis||||
1665423|NCT01460342|3064444|Superiority or Other||Mean Difference (Final Values)|-1.5|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|-2.4|-0.6|||Mixed Models Analysis||||
1665424|NCT01460225|3064464|Equivalence|Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.||||||0.122|||||||t-test, 2 sided|||Comparison of meal retention between pre-treatment and post treatment at 4 hours post meal|
1665425|NCT01460225|3064464|Equivalence|Based on the results of Camilleri et al, this should be adequate to detect up to a 30% difference in gastric emptying scan times with a p-value of 0.05 and 80% power.||||||0.003|||||||t-test, 2 sided|||Comparison of meal retention between pre-treatment and post treatment at 2 hours post meal|
1665426|NCT01460160|3064475|Non-Inferiority|non-inferiority margin = 5%. One-sided type I error rate of 0.05|Estimate of difference|6.91||||0.271|2-Sided|90.0|-3.3|17.2||Superiority test versus EsPhALL|Chi-squared||Treatment difference (CA180372 - EsPhALL) Test if lower confidence limit is above -5%|Difference in 3-year binomial EFS rate for all treated participants (dasatinib plus chemotherapy) vs. continuous imatinib plus chemotherapy in the Amended EsPhALL Trial Historical Control|
1665427|NCT01460160|3064475|Superiority||Estimate of Difference|16.86||||0.032|2-Sided|90.0|3.9|29.8||Superiority test versus AIEOP-BFM 2000|Chi-squared||Treatment difference (CA180372 - AIEOP-BFM 2000)|Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in AIEOP-BFM 2000 historical control|
1665450|NCT01459653|3064598|Superiority or Other||Odds Ratio (OR)|1.369|||<|0.001|2-Sided|95.0|1.14|1.643|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665451|NCT01459653|3064598|Superiority or Other||Odds Ratio (OR)|0.579|||<|0.004|2-Sided|95.0|0.398|0.842|||Regression, Logistic|||Zarzio duration: 1-3 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665428|NCT01459783|3064495|Superiority or Other||Mean Difference (Final Values)|0.9||||0.49|2-Sided|95.0|-1.74|3.55||We used Bonferroni adjustment for multiple testing and a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes. The behavior measure is analyzed two ways: total number of problems (reported here), and reaction score.|Regression, Linear|Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, & intervention duration.|The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse problems for the in-person arm compared to the phone arm.|Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.|
1665429|NCT01459783|3064496|Superiority or Other||Mean Difference (Final Values)|0.91||||0.76|2-Sided|95.0|-5.13|6.95||We adopted Bonferroni adjustment for multiple testing and used a significance level of .05/3 = 0.017 to interpret the results for our primary outcomes.|Regression, Linear|Multivariate analyses included non-response weights and controlled for study arm, stratification variables, baseline values, & intervention duration.|The difference in differences at 12 months is reported as in-person arm minus phone arm values from a multivariable analysis. A positive adjusted difference means worse burden for the in-person arm compared to the phone arm.|Analyses were intention-to-treat. Due to attrition and those ineligible for 12-month follow-up due to study ending before that time, we created survey non-response weights for each wave. Prior to the study, a sample size of 125 participants per group was based on the two primary outcomes, with a Type I Error of 0.025 (Bonferroni adjustment), setting a 0.5-SD difference in outcomes as clinically important, 80% power, 0.45 SD difference in difference in outcomes between groups, and 25% attrition.|
1665430|NCT01459705|3064587|Superiority or Other||Slope|13.91|Standard Error of the Mean|6.7|||2-Sided||||||||||
1665431|NCT01459705|3064588|Superiority or Other||Slope|15.07|Standard Deviation|6.03|||2-Sided||||||||||
1665432|NCT01459705|3064589|Superiority or Other||Slope|9.04|Standard Error of the Mean|5.11|||2-Sided||||||||||
1665433|NCT01459705|3064589|Superiority or Other||Slope|-13.3|Standard Error of the Mean|4.77|||2-Sided||||||||||
1665434|NCT01459705|3064589|Superiority or Other||Slope|-22.34|Standard Deviation|4.69|||1-Sided||||||||||
1665435|NCT01459653|3064592|Superiority or Other||Odds Ratio (OR)|14.8703|||<|0.0001|2-Sided|95.0|5.9567|37.1225|||Regression, Logistic|||Poor performance (ECOG >=2) during study as patient-level predictor|
1665436|NCT01459653|3064592|Superiority or Other||Odds Ratio (OR)|14.8703|||<|0.0001|2-Sided|95.0|5.9567|37.1225|||Regression, Logistic|||Female gender as patient-level predictor for cancer-related mortality|
1665437|NCT01459653|3064596|Superiority or Other||Odds Ratio (OR)|17.535|||<|0.0001|2-Sided|95.0|8.2159|37.4243|||Regression, Logistic|||Poor performance (ECOG >=2) during study as patient level predictor|
1665438|NCT01459653|3064596|Superiority or Other||Odds Ratio (OR)|2.3049|||<|0.0057|2-Sided|95.0|1.2754|4.1656|||Regression, Logistic|||Liver/renal/cardiac comorbidity as patient level predictor|
1665439|NCT01459653|3064596|Superiority or Other||Odds Ratio (OR)|2.2064|||<|0.0116|2-Sided|95.0|1.1931|4.0803|||Regression, Logistic|||Patient level predictor: History of anemia at enrollment|
1665440|NCT01459653|3064597|Superiority or Other||Odds Ratio (OR)|0.558||||0.028|2-Sided|95.0|0.332|0.939|||Regression, Logistic|||GIS at enrollment (1 vs. 0) as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665441|NCT01459653|3064597|Superiority or Other||Odds Ratio (OR)|2.053||||0.002|2-Sided|95.0|1.295|3.256|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665442|NCT01459653|3064597|Superiority or Other||Odds Ratio (OR)|0.438|||<|0.001|2-Sided|95.0|0.291|0.66|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665443|NCT01459653|3064597|Superiority or Other||Odds Ratio (OR)|2.68|||<|0.016|2-Sided|95.0|1.2|5.984|||Regression, Logistic|||History of repeated infections at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665444|NCT01459653|3064597|Superiority or Other||Odds Ratio (OR)|1.898|||<|0.005|2-Sided|95.0|1.209|2.979|||Regression, Logistic|||History of CIN4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665445|NCT01459653|3064597|Superiority or Other||Odds Ratio (OR)|1.621|||<|0.006|2-Sided|95.0|1.152|2.281|||Regression, Logistic|||Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665446|NCT01459653|3064598|Superiority or Other||Odds Ratio (OR)|1.596||||0.017|2-Sided|95.0|1.088|2.34|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665447|NCT01459653|3064598|Superiority or Other||Odds Ratio (OR)|1.545||||0.002|2-Sided|95.0|1.175|2.033|||Regression, Logistic|||Female gender as patient-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665448|NCT01459653|3064598|Superiority or Other||Odds Ratio (OR)|4.064|||<|0.001|2-Sided|95.0|3.096|5.336|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665449|NCT01459653|3064598|Superiority or Other||Odds Ratio (OR)|3.499|||<|0.001|2-Sided|95.0|2.456|4.985|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665482|NCT01459653|3064605|Superiority or Other||Odds Ratio (OR)|2.572|||<|0.005|2-Sided|95.0|1.331|4.969|||Regression, Logistic|||Concomitant antibiotic prophylaxis as patient-level predictor for CIN grade 4 episode|
1665452|NCT01459653|3064598|Superiority or Other||Odds Ratio (OR)|0.644|||<|0.003|2-Sided|95.0|0.489|0.859|||Regression, Logistic|||Zarzio duration: 4-5 days vs. 6 or more as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665453|NCT01459653|3064598|Superiority or Other||Odds Ratio (OR)|0.59|||<|0.002|2-Sided|95.0|0.424|0.821|||Regression, Logistic|||GIS (1 vs. 0) as cycle-level predictor for composite outcome (any of CIN Grade 4, FN, CIN/FN-related hospitalization, CIN/FN-related chemotherapy disturbance)|
1665454|NCT01459653|3064599|Superiority or Other||Odds Ratio (OR)|2.594||||0.001|2-Sided|95.0|1.469|4.581|||Regression, Logistic|||History of CIN4 at enrollment as patient-level predictor for CIN/FN-related chemotherapy disturbance|
1665455|NCT01459653|3064599|Superiority or Other||Odds Ratio (OR)|1.965||||0.006|2-Sided|95.0|1.218|3.172|||Regression, Logistic|||Female gender as patient-level predictor for CIN/FN-related chemotherapy disturbance|
1665456|NCT01459653|3064600|Superiority or Other||Odds Ratio (OR)|3.344||||0.01|2-Sided|95.0|1.342|8.331|||Regression, Logistic|||Center type: academic-affiliated vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance|
1665457|NCT01459653|3064600|Superiority or Other||Odds Ratio (OR)|2.456||||0.024|2-Sided|95.0|1.127|5.353|||Regression, Logistic|||Center type: academic vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance|
1665458|NCT01459653|3064600|Superiority or Other||Odds Ratio (OR)|1.001|||<|0.001|2-Sided|95.0|1.0|1.001|||Regression, Logistic|||Chemotherapy-treated cancer patients in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance|
1665459|NCT01459653|3064600|Superiority or Other||Odds Ratio (OR)|0.999|||<|0.006|2-Sided|95.0|0.999|1.0|||Regression, Logistic|||Cancer patients seen in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance|
1665460|NCT01459653|3064600|Superiority or Other||Odds Ratio (OR)|0.336|||<|0.007|2-Sided|95.0|0.152|0.74|||Regression, Logistic|||Hematological cancer (vs. oncologic) as patient-level predictor for CIN/FN-related chemotherapy disturbance|
1665461|NCT01459653|3064600|Superiority or Other||Odds Ratio (OR)|8.931|||<|0.001|2-Sided|95.0|5.426|14.699|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for CIN/FN-related chemotherapy disturbance|
1665462|NCT01459653|3064601|Superiority or Other||Odds Ratio (OR)|3.108||||0.001|2-Sided|95.0|1.56|6.192|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization|
1665463|NCT01459653|3064601|Superiority or Other||Odds Ratio (OR)|0.382||||0.002|2-Sided|95.0|0.21|0.695|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization|
1665464|NCT01459653|3064601|Superiority or Other||Odds Ratio (OR)|2.473|||<|0.001|2-Sided|95.0|1.55|3.946|||Regression, Logistic|||ECOG ≥2 during study as patient-level predictor for CIN/FN-related hospitalization|
1665465|NCT01459653|3064602|Superiority or Other||Odds Ratio (OR)|4.843||||0.001|2-Sided|95.0|1.964|11.942|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for CIN/FN-related hospitalization|
1665466|NCT01459653|3064602|Superiority or Other||Odds Ratio (OR)|0.385||||0.024|2-Sided|95.0|0.168|0.879|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization|
1665467|NCT01459653|3064602|Superiority or Other||Odds Ratio (OR)|1.863||||0.032|2-Sided|95.0|1.054|3.293|||Regression, Logistic|||Under- vs. correctly prophylacted as patient-level predictor for CIN/FN-related hospitalization|
1665468|NCT01459653|3064602|Superiority or Other||Odds Ratio (OR)|2.205||||0.001|2-Sided|95.0|1.38|3.524|||Regression, Logistic|||CIN1/4 in previous cycles as cycle-level predictor for CIN/FN-related hospitalization|
1665469|NCT01459653|3064602|Superiority or Other||Odds Ratio (OR)|3.296|||<|0.001|2-Sided|95.0|1.791|6.065|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for CIN/FN-related hospitalization|
1665470|NCT01459653|3064602|Superiority or Other||Odds Ratio (OR)|1.814|||<|0.001|2-Sided|95.0|1.397|2.355|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for CIN/FN-related hospitalization|
1665471|NCT01459653|3064603|Superiority or Other||Odds Ratio (OR)|3.261||||0.011|2-Sided|95.0|1.315|8.084|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for FN episode|
1665472|NCT01459653|3064603|Superiority or Other||Odds Ratio (OR)|0.232|||<|0.001|2-Sided|95.0|0.108|0.499|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for FN episode|
1665473|NCT01459653|3064603|Superiority or Other||Odds Ratio (OR)|2.562|||<|0.001|2-Sided|95.0|1.45|4.527|||Regression, Logistic|||Concomitant antibiotic prophylaxis as patient-level predictor for FN episode|
1665474|NCT01459653|3064603|Superiority or Other||Odds Ratio (OR)|2.398|||<|0.001|2-Sided|95.0|1.61|3.57|||Regression, Logistic|||ECOG ≥2 during study as patient-level predictor for FN episode|
1665475|NCT01459653|3064603|Superiority or Other||Odds Ratio (OR)|0.975|||<|0.003|2-Sided|95.0|0.958|0.991|||Regression, Logistic|||Patient age (per 1 year) as patient-level predictor for FN episode|
1665476|NCT01459653|3064604|Superiority or Other||Odds Ratio (OR)|3.501||||0.025|2-Sided|95.0|1.169|10.487|||Regression, Logistic|||Under- vs. over-prophylacted as patient-level predictor for FN episode|
1665477|NCT01459653|3064604|Superiority or Other||Odds Ratio (OR)|0.215||||0.01|2-Sided|95.0|0.067|0.687|||Regression, Logistic|||History of anaemia at enrollment as patient-level predictor for FN episode|
1665478|NCT01459653|3064604|Superiority or Other||Odds Ratio (OR)|2.19||||0.002|2-Sided|95.0|1.342|3.574|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for FN episode|
1665479|NCT01459653|3064604|Superiority or Other||Odds Ratio (OR)|4.704|||<|0.001|2-Sided|95.0|2.777|7.968|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for FN episode|
1665480|NCT01459653|3064604|Superiority or Other||Odds Ratio (OR)|1.673|||<|0.001|2-Sided|95.0|1.284|2.179|||Regression, Logistic|||ECOG score (per 1 point) as cycle-level predictor for FN episode|
1665481|NCT01459653|3064605|Superiority or Other||Odds Ratio (OR)|0.328|||<|0.001|2-Sided|95.0|0.193|0.557|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode|
1665636|NCT01457924|3064972|Superiority or Other||Ratio|0.35|||<|0.001|2-Sided|95.0|0.221|0.548|||Non-Linear Emax Model||||
1665483|NCT01459653|3064605|Superiority or Other||Odds Ratio (OR)|2.925|||<|0.001|2-Sided|95.0|1.592|5.374|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode|
1665484|NCT01459653|3064606|Superiority or Other||Odds Ratio (OR)|0.452||||0.003|2-Sided|95.0|0.267|0.766|||Regression, Logistic|||Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode|
1665485|NCT01459653|3064606|Superiority or Other||Odds Ratio (OR)|2.46|||<|0.001|2-Sided|95.0|1.542|3.925|||Regression, Logistic|||History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode|
1665486|NCT01459653|3064606|Superiority or Other||Odds Ratio (OR)|4.083|||<|0.001|2-Sided|95.0|3.242|7.092|||Regression, Logistic|||CIN1/4 in previous cycle as cycle-level predictor for CIN grade 4 episode|
1665487|NCT01459653|3064606|Superiority or Other||Odds Ratio (OR)|4.795|||<|0.001|2-Sided|95.0|3.242|7.092|||Regression, Logistic|||Concomitant antibiotic prophylaxis as cycle-level predictor for CIN grade 4 episode|
1665488|NCT01459653|3064606|Superiority or Other||Odds Ratio (OR)|0.544|||<|0.003|2-Sided|95.0|0.365|0.812|||Regression, Logistic|||GIS (1 vs. 0) as cycle-level predictor for CIN grade 4 episode|
1665489|NCT01459653|3064611|Superiority or Other||Intra-class correlation coefficient|0.5|||<|0.0001|2-Sided||||||ANCOVA|||ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the within-patient level.|
1665490|NCT01459653|3064611|Superiority or Other||Intra-class correlation coefficient|0.41|||<|0.0001|2-Sided||||||ANCOVA|||ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the patient within center-level.|
1665491|NCT01459653|3064611|Superiority or Other||Intra-class correlation coefficient|0.09|||<|0.0003|2-Sided||||||ANCOVA||The intra-class correlation coefficient (ICC) was computed to quantify the variability in patient outcome attributable to within-center variability before any patient-level determinants are considered.|ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the center-level.|
1665492|NCT01459653|3064612|Superiority or Other||Slope|1.03|||<|0.0001|2-Sided|95.0|1.02|1.05|||Regression, Linear|||Hb (per g/dL) as predictor for ANC|
1665493|NCT01459653|3064612|Superiority or Other||Slope|1.04|||<|0.0235|2-Sided|95.0|1.01|1.08|||Regression, Linear|||ECOG (per 1 point) as predictor for ANC|
1665494|NCT01459653|3064612|Superiority or Other||Slope|0.86|||<|0.0001|2-Sided|95.0|0.8|0.92|||Regression, Logistic|||Patient gender (female vs male) as predictor for ANC|
1665495|NCT01459653|3064612|Superiority or Other||Slope|0.81|||<|0.0004|2-Sided|95.0|0.72|0.91|||Regression, Logistic|||Tumor type (hematological vs solid) as predictor for ANC|
1665496|NCT01459653|3064612|Superiority or Other||Slope|1.11|||<|0.0079|2-Sided|95.0|1.03|1.19|||Regression, Logistic|||Study drug dose (higher vs lower) as predictor for ANC|
1665497|NCT01459653|3064612|Superiority or Other||Slope|1.04|||<|0.4469|2-Sided|95.0|0.94|1.15|||Regression, Logistic|degrees of freedom: 3181||GCSF decision (Under vs over) as predictor for ANC|
1665498|NCT01459653|3064612|Superiority or Other||Slope|0.89|||<|0.0019|2-Sided|95.0|0.82|0.96|||Regression, Logistic|degrees of freedom: 3181||GCSF decision (Over vs correct) as predictor for ANC|
1665499|NCT01459653|3064612|Superiority or Other||Slope|0.92|||<|0.0683|2-Sided|95.0|0.84|1.01|||Regression, Logistic|degrees of freedom: 3181||GCSF treatment decision (under vs correct) as predictor for ANC|
1665500|NCT01459653|3064613|Superiority or Other|||||||0.0301|||||||Log Rank||||
1665501|NCT01459653|3064614|Superiority or Other|||||||0.0002|||||||Log Rank||||
1665502|NCT01459653|3064615|Superiority or Other|||||||0.383|||||||Log Rank||||
1665503|NCT01459653|3064616|Superiority or Other|||||||0.763|||||||Log Rank||||
1665504|NCT01459653|3064617|Superiority or Other|||||||0.2435|||||||Log Rank||||
1665505|NCT01459653|3064618|Superiority or Other|||||||0.5977|||||||Log Rank||||
1665506|NCT01459653|3064635|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1665507|NCT01459653|3064636|Superiority or Other||Odds Ratio (OR)|0.735||||0.2698|2-Sided|95.0|0.4255|1.2698|||Chi-squared||||
1665508|NCT01459653|3064644|Superiority or Other||Slope|0.0741|||<|0.0001|2-Sided|95.0|-0.0452|0.1029|||ANOVA|degrees of freedom: 4505|||
1665509|NCT01459653|3064645|Superiority or Other||Slope|0.0018||||0.8968|2-Sided|95.0|-0.0259|0.0295|||ANOVA|degrees of freedom: 4516|||
1665510|NCT01459653|3064646|Superiority or Other||Slope|0.1031||||0.0677|2-Sided|95.0|-0.0075|0.2136|||ANOVA|degrees of freedom: 4516|||
1665511|NCT01459653|3064654|Superiority or Other||Slope|0.3812|||<|0.0001|2-Sided|95.0|0.233|0.5295|||ANOVA|degrees of freedom: 4495|||
1665512|NCT01459653|3064655|Superiority or Other||Slope|-0.2739||||0.0103|2-Sided|95.0|-0.4832|-0.0646|||ANOVA|degrees of freedom: 4507|||
1665513|NCT01459653|3064656|Superiority or Other||Slope|1.0628|||<|0.0001|2-Sided|95.0|0.6382|1.4874|||ANOVA|degrees of freedom: 4507|||
1665514|NCT01459653|3064664|Superiority or Other||Odds Ratio (OR)|1.2683||||0.0067|2-Sided|95.0|1.068|1.5061|||Chi-squared||||
1665515|NCT01459653|3064665|Superiority or Other||Odds Ratio (OR)|0.9451||||0.7509|2-Sided|95.0|0.6671|1.3391|||Chi-squared||||
1665516|NCT01459653|3064666|Superiority or Other||Odds Ratio (OR)|0.4963|||<|0.0001|2-Sided|95.0|0.373|0.6605|||Chi-squared||||
1665517|NCT01459653|3064667|Superiority or Other||Odds Ratio (OR)|2.2989|||<|0.0001|2-Sided|95.0|1.8113|2.9177|||Chi-squared||||
1665518|NCT01459653|3064677|Superiority or Other||Odds Ratio (OR)|0.8794||||0.6483|2-Sided|95.0|0.5063|1.5276|||Chi-squared||||
1665519|NCT01459653|3064678|Superiority or Other||Odds Ratio (OR)|1.1897||||0.1432|2-Sided|95.0|0.9428|1.5012|||Chi-squared||||
1665520|NCT01459653|3064679|Superiority or Other||Odds Ratio (OR)|0.884||||0.3038|2-Sided|95.0|0.6989|1.1182|||Chi-squared||||
1665521|NCT01459068|3064695|Non-Inferiority or Equivalence|no power calculations for secondary measures|Mean Difference (Net)|-0.03|Standard Error of the Mean|0.26||0.896|2-Sided|95.0|-0.44|0.5|||longitudinal model||||
1665522|NCT01459068|3064696|Non-Inferiority or Equivalence|no power calculations for secondary measures|Mean Difference (Net)|-0.24|Standard Error of the Mean|0.05|<|0.001|2-Sided|95.0|-0.34|-0.15|||longitudinal model||||
1665637|NCT01457924|3064972|Superiority or Other||Ratio|0.35|||<|0.001|2-Sided|95.0|0.221|0.548|||Non-Linear Emax Model||||
1665523|NCT01459068|3064697|Non-Inferiority or Equivalence|no power calculations on secondary outcomes|Mean Difference (Net)|-0.48|Standard Error of the Mean|0.07|<|0.001|2-Sided|95.0|-0.61|-0.34|||longitudinal model||||
1665524|NCT01459068|3064698|Non-Inferiority or Equivalence|We estimated 150 participants in each arm using the test for paired means, based on a moderate effect size (0.50), 80% power, two-tailed 5% significance level, design effect of 1.5, and up to a 50% expected drop-out rate (due to frequent cross-border movement).|Mean Difference (Net)|-0.43|Standard Error of the Mean|0.04|<|0.001|2-Sided|95.0|-0.51|-0.35||a priori threshold for significance set at 0.05|longitudinal model|longitudinal analysis modeling within-person change in mean scores|||
1665525|NCT01459068|3064699|Non-Inferiority or Equivalence|power calculations were not done for secondary outcomes|Mean Difference (Net)|-0.44|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.59|-0.28|||longitudinal model||||
1665526|NCT01459068|3064700|Non-Inferiority or Equivalence|We estimated 150 participants in each arm using the test for paired means, based on a moderate effect size (0.50), 80% power, two-tailed 5% significance level, design effect of 1.5, and up to a 50% expected drop-out rate (due to frequent cross-border movement).|Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.05|<|0.001|2-Sided|95.0|-0.59|-0.4||a priori threshold for statistical significance was 0.05.|longitudinal model|longitudinal to model within-person change in mean scores|||
1665527|NCT01458951|3064714|Superiority or Other||Least Square Mean Difference|-1.6|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|-2.2|-1.0|||ANCOVA|||The change from baseline at Week 8 was analyzed using an analysis of covariance (ANCOVA) model with treatment group, prior treatment with anti-TNF, steroid use at baseline and geographic region as factors and baseline as a covariate based on the observed-case data.|
1665528|NCT01458951|3064715|Superiority or Other||Least square mean difference|-1.3|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|-1.7|-0.9|||Mixed Models Analysis|||At Week 8: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.|
1665529|NCT01458951|3064715|Superiority or Other||Least square mean difference|-1.2|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|-1.6|-0.7|||Mixed Models Analysis|||At Week 4: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.|
1665530|NCT01458951|3064715|Superiority or Other||Least square mean difference|-1.0|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|-1.4|-0.6|||Mixed Models Analysis|||At Week 2: The change from baseline was analyzed using mixed effect model with treatment group, prior treatment with antiTNF, steroid use at baseline, geographic region, visit and visit by treatment group all as fixed effects, and subjects as a random effect.|
1665531|NCT01458951|3064717|Superiority or Other||Percentage difference|3.3||||0.1408|2-Sided|95.0|0.1|6.6|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665532|NCT01458951|3064718|Superiority or Other||Percentage difference|8.0||||0.009|2-Sided|95.0|3.9|12.2|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665533|NCT01458951|3064719|Superiority or Other||Difference in percentage|13.2||||0.0004|2-Sided|95.0|8.3|18.1|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Difference in its percentage and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665534|NCT01458951|3064720|Superiority or Other||Percentage difference|5.2||||0.0425|2-Sided|95.0|1.8|8.6|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665535|NCT01458951|3064721|Superiority or Other||Percentage difference|26.4|||<|0.0001|2-Sided|95.0|16.8|36.0|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665536|NCT01458951|3064722|Superiority or Other||Percentage difference|16.8||||0.0002|2-Sided|95.0|9.5|24.1|||CMH Chi-square Test|||P-value was based on CMH chi-square test stratified by prior treatment with anti-TNF, steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665537|NCT01458951|3064723|Superiority or Other||Percentage difference|13.0||||0.0005|2-Sided|95.0|8.1|17.9|||CMH Chi-square Test|||P-value based on Cochran-Mantel Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using non-responder imputation (NRI).|
1665538|NCT01458574|3064770|Superiority or Other||Difference in percentage|11.1||||0.0121|2-Sided|95.0|2.3|19.9|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665539|NCT01458574|3064770|Superiority or Other||Difference in percentage|7.9||||0.0419|2-Sided|95.0|0.1|15.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665540|NCT01458574|3064771|Superiority or Other||Difference in percentage|16.7||||0.0029|2-Sided|95.0|5.5|27.9|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665541|NCT01458574|3064771|Superiority or Other||Difference in percentage|16.8||||0.0018|2-Sided|95.0|6.2|27.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665542|NCT01458574|3064771|Superiority or Other||Difference in percentage|13.2||||0.0103|2-Sided|95.0|2.4|24.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665543|NCT01458574|3064771|Superiority or Other||Difference in percentage|12.9||||0.0074|2-Sided|95.0|2.6|23.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665544|NCT01458574|3064772|Superiority or Other||Difference in percentage|46.2|||<|0.0001|2-Sided|95.0|31.0|61.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665545|NCT01458574|3064772|Superiority or Other||Difference in percentage|34.4|||<|0.0001|2-Sided|95.0|20.1|48.8|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665546|NCT01458574|3064772|Superiority or Other||Difference in percentage|48.4|||<|0.0001|2-Sided|95.0|32.7|64.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665547|NCT01458574|3064772|Superiority or Other||Difference in percentage|38.6|||<|0.0001|2-Sided|95.0|23.4|53.8|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665548|NCT01458574|3064773|Superiority or Other||Difference in percentage|42.2|||<|0.0001|2-Sided|95.0|27.9|56.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665549|NCT01458574|3064773|Superiority or Other||Difference in percentage|31.8|||<|0.0001|2-Sided|95.0|18.8|44.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665550|NCT01458574|3064774|Superiority or Other||Difference in percentage|46.2|||<|0.0001|2-Sided|95.0|31.0|61.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665551|NCT01458574|3064774|Superiority or Other||Difference in percentage|36.0|||<|0.0001|2-Sided|95.0|21.6|50.3|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665552|NCT01458574|3064774|Superiority or Other||Difference in percentage|48.4|||<|0.0001|2-Sided|95.0|32.7|64.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665553|NCT01458574|3064774|Superiority or Other||Difference in percentage|40.1|||<|0.0001|2-Sided|95.0|25.0|55.3|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665554|NCT01458574|3064775|Superiority or Other||Least Square Mean Difference|-3.3|||<|0.0001|2-Sided|95.0|-4.1|-2.5|||Linear mixed effect model|||At Week 52|
1665555|NCT01458574|3064775|Superiority or Other||Least Square Mean Difference|-2.6|||<|0.0001|2-Sided|95.0|-3.4|-1.7|||Linear mixed effect model|||At Week 52|
1665556|NCT01458574|3064775|Superiority or Other||Least Square Mean Difference|-2.8|||<|0.0001|2-Sided|95.0|-3.5|-2.2|||Linear mixed effect model|||At Week 24|
1665557|NCT01458574|3064775|Superiority or Other||Least Square Mean Difference|-2.6|||<|0.0001|2-Sided|95.0|-3.2|-1.9|||Linear mixed effect model|||At Week 24|
1665558|NCT01458574|3064777|Superiority or Other||Difference in percentage|4.6||||0.0064|2-Sided|95.0|1.4|7.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665559|NCT01458574|3064777|Superiority or Other||Difference in percentage|5.6||||0.0029|2-Sided|95.0|2.1|9.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665560|NCT01458574|3064778|Superiority or Other||Difference in percentage|12.7|||<|0.0001|2-Sided|95.0|6.8|18.6|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665561|NCT01458574|3064778|Superiority or Other||Difference in percentage|10.6|||<|0.0004|2-Sided|95.0|5.0|16.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665785|NCT01455194|3065300|Superiority or Other|||||||0.146|||||||Fisher Exact|||Well-controlled Asthma|
1665562|NCT01458574|3064778|Superiority or Other||Difference in percentage|8.1|||<|0.0021|2-Sided|95.0|2.8|13.5|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665563|NCT01458574|3064778|Superiority or Other||Difference in percentage|12.1|||<|0.0001|2-Sided|95.0|6.3|17.9|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665564|NCT01458574|3064779|Superiority or Other||Difference in percentage|13.2|||<|0.0001|2-Sided|95.0|7.7|18.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665565|NCT01458574|3064779|Superiority or Other||Difference in percentage|11.1|||<|0.0001|2-Sided|95.0|5.9|16.4|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665566|NCT01458574|3064780|Superiority or Other||Difference in percentage|19.8|||<|0.0001|2-Sided|95.0|12.7|27.0|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665567|NCT01458574|3064780|Superiority or Other||Difference in percentage|15.7|||<|0.0001|2-Sided|95.0|8.8|22.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665568|NCT01458574|3064780|Superiority or Other||Difference in percentage|15.3|||<|0.0001|2-Sided|95.0|8.5|22.0|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665569|NCT01458574|3064780|Superiority or Other||Difference in percentage|17.2|||<|0.0001|2-Sided|95.0|10.3|24.0|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665570|NCT01458574|3064781|Superiority or Other||Difference in percentage|3.0||||0.035|2-Sided|95.0|0.3|5.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665571|NCT01458574|3064781|Superiority or Other||Difference in percentage|5.6||||0.0029|2-Sided|95.0|2.1|9.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665572|NCT01458574|3064782|Superiority or Other||Difference in percentage|11.2|||<|0.0001|2-Sided|95.0|5.5|16.9|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665573|NCT01458574|3064782|Superiority or Other||Difference in percentage|10.6|||<|0.0004|2-Sided|95.0|5.0|16.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665574|NCT01458574|3064782|Superiority or Other||Difference in percentage|6.6|||<|0.0092|2-Sided|95.0|1.5|11.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665575|NCT01458574|3064782|Superiority or Other||Difference in percentage|10.1|||<|0.0006|2-Sided|95.0|4.5|15.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665576|NCT01458574|3064783|Superiority or Other||Difference in percentage|20.8|||<|0.0001|2-Sided|95.0|14.0|27.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665577|NCT01458574|3064783|Superiority or Other||Difference in percentage|17.2|||<|0.0001|2-Sided|95.0|10.6|23.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665578|NCT01458574|3064784|Superiority or Other||Difference in percentage|30.0|||<|0.0001|2-Sided|95.0|21.9|38.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665579|NCT01458574|3064784|Superiority or Other||Difference in percentage|23.2|||<|0.0001|2-Sided|95.0|15.3|31.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665786|NCT01455194|3065300|Superiority or Other|||||||0.4186|||||||Fisher Exact|||Well-controlled Asthma|
1667983|NCT01416636|3069728|Superiority|||||||0.307|||||||Wilcoxon (Mann-Whitney)||||
1665580|NCT01458574|3064784|Superiority or Other||Difference in percentage|24.4|||<|0.0001|2-Sided|95.0|16.4|32.4|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665581|NCT01458574|3064784|Superiority or Other||Difference in percentage|23.2|||<|0.0001|2-Sided|95.0|15.3|31.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665582|NCT01458574|3064785|Superiority or Other||Difference in percentage|40.2|||<|0.0001|2-Sided|95.0|31.4|49.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665583|NCT01458574|3064785|Superiority or Other||Difference in percentage|29.8|||<|0.0001|2-Sided|95.0|20.9|38.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665584|NCT01458574|3064786|Superiority or Other||Difference in percentage|41.7|||<|0.0001|2-Sided|95.0|32.9|50.5|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665585|NCT01458574|3064786|Superiority or Other||Difference in percentage|31.3|||<|0.0001|2-Sided|95.0|22.4|40.2|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665586|NCT01458574|3064786|Superiority or Other||Difference in percentage|37.2|||<|0.0001|2-Sided|95.0|28.1|46.4|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665587|NCT01458574|3064786|Superiority or Other||Difference in percentage|30.3|||<|0.0001|2-Sided|95.0|20.9|39.7|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665588|NCT01458574|3064787|Superiority or Other||Difference in percentage|40.5|||<|0.0001|2-Sided|95.0|28.7|52.3|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665589|NCT01458574|3064787|Superiority or Other||Difference in percentage|24.4|||<|0.0001|2-Sided|95.0|13.8|35.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665590|NCT01458574|3064788|Superiority or Other||Difference in percentage|43.2|||<|0.0001|2-Sided|95.0|31.1|55.3|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665591|NCT01458574|3064788|Superiority or Other||Difference in percentage|30.0|||<|0.0001|2-Sided|95.0|18.7|41.4|||CMH chi-square test|||At Week 52: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665592|NCT01458574|3064788|Superiority or Other||Difference in percentage|44.5|||<|0.0001|2-Sided|95.0|31.8|57.2|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665593|NCT01458574|3064788|Superiority or Other||Difference in percentage|30.6|||<|0.0001|2-Sided|95.0|18.1|43.1|||CMH chi-square test|||At Week 24: P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665594|NCT01458574|3064789|Superiority or Other||Difference in percentage|26.4|||<|0.0001|2-Sided|95.0|19.0|33.8|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665595|NCT01458574|3064789|Superiority or Other||Difference in percentage|21.2|||<|0.0001|2-Sided|95.0|14.1|28.3|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665596|NCT01458574|3064790|Superiority or Other||Difference in percentage|29.0|||<|0.0001|2-Sided|95.0|20.3|37.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665597|NCT01458574|3064790|Superiority or Other||Difference in percentage|26.8|||<|0.0001|2-Sided|95.0|18.1|35.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665598|NCT01458574|3064791|Superiority or Other||Difference in percentage|20.3|||<|0.0001|2-Sided|95.0|13.5|27.1|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665599|NCT01458574|3064791|Superiority or Other||Difference in percentage|17.2|||<|0.0001|2-Sided|95.0|10.6|23.7|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665600|NCT01458574|3064792|Superiority or Other||Difference in percentage|24.4|||<|0.0001|2-Sided|95.0|16.4|32.4|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665601|NCT01458574|3064792|Superiority or Other||Difference in percentage|22.7|||<|0.0001|2-Sided|95.0|14.8|30.6|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665602|NCT01458574|3064793|Superiority or Other||Difference in percentage|42.2|||<|0.0001|2-Sided|95.0|27.9|56.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665603|NCT01458574|3064793|Superiority or Other||Difference in percentage|30.3|||<|0.0001|2-Sided|95.0|17.4|43.2|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665604|NCT01458574|3064794|Superiority or Other||Difference in percentage|32.6|||<|0.0001|2-Sided|95.0|24.2|41.0|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665605|NCT01458574|3064794|Superiority or Other||Difference in percentage|24.2|||<|0.0001|2-Sided|95.0|16.0|32.5|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665606|NCT01458574|3064795|Superiority or Other||Difference in percentage|29.5|||<|0.0001|2-Sided|95.0|21.4|37.6|||CMH chi-square test|||P-value based on CMH chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using NRI.|
1665607|NCT01458574|3064795|Superiority or Other||Difference in percentage|23.2|||<|0.0001|2-Sided|95.0|15.3|31.2|||CMH chi-square test|||P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by induction study treatment and baseline remission status. Difference and its 95 percent (%) confidence interval (CI) based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).|
1665608|NCT01458535|3064819|Superiority or Other|||||||0.045|||||||Cochran-Mantel-Haenszel||||
1665609|NCT01458535|3064819|Superiority or Other|||||||0.999|||||||Cochran-Mantel-Haenszel||||
1665610|NCT01458535|3064819|Superiority or Other|||||||0.157|||||||Cochran-Mantel-Haenszel||||
1665611|NCT01458522|3064827|Other|||||||0.512|||||||Poisson regression model||||
1665612|NCT01458171|3064880|Superiority or Other||Annualized Rate|0.0|||||1-Sided|99.0||0.523|||||||
1665613|NCT01458171|3064880|Superiority or Other||Annualized Rate|0.0|||||1-Sided|99.0||0.45|||||||
1665614|NCT01457950|3064961|Superiority or Other||Mean Difference (Final Values)|3.21|||<|0.0001|2-Sided|95.0|2.06|4.36|||ANCOVA||||
1665615|NCT01457924|3064965|Superiority or Other||Ratio|0.19|||<|0.001|2-Sided|95.0|0.11|0.35|||Generalized Linear Model||||
1665616|NCT01457924|3064965|Superiority or Other||Ratio|0.4|||<|0.006|2-Sided|95.0|0.21|0.77|||Generalized Linear Model||||
1665617|NCT01457924|3064965|Superiority or Other||Ratio|0.34|||<|0.002|2-Sided|95.0|0.17|0.68|||Generalized Linear Model||||
1665618|NCT01457924|3064965|Superiority or Other||Ratio|0.29|||<|0.001|2-Sided|95.0|0.15|0.58|||Generalized Linear Model||||
1665619|NCT01457924|3064966|Superiority or Other||Ratio|0.24||||0.003|2-Sided|95.0|0.1|0.62|||Generalized Linear Model||||
1665620|NCT01457924|3064966|Superiority or Other||Ratio|0.46||||0.181|2-Sided|95.0|0.15|1.43|||Generalized Linear Model||||
1665621|NCT01457924|3064966|Superiority or Other||Ratio|0.5||||0.248|2-Sided|95.0|0.15|1.63|||Generalized Linear Model||||
1665622|NCT01457924|3064966|Superiority or Other||Ratio|0.18||||0.004|2-Sided|95.0|0.05|0.58|||Generalized Linear Model||||
1665623|NCT01457924|3064967|Superiority or Other||Ratio|0.25||||0.009|2-Sided|95.0|0.09|0.71|||Non-Linear Emax Model||||
1665624|NCT01457924|3064967|Superiority or Other||Ratio|0.5||||0.285|2-Sided|95.0|0.14|1.78|||Generalized Linear Model||||
1665625|NCT01457924|3064967|Superiority or Other||Ratio|0.49||||0.296|2-Sided|95.0|0.13|1.86|||Generalized Linear Model||||
1665626|NCT01457924|3064967|Superiority or Other||Ratio|0.22||||0.026|2-Sided|95.0|0.06|0.84|||Generalized Linear Model||||
1665627|NCT01457924|3064968|Superiority or Other||Ratio|0.32|||<|0.001|2-Sided|95.0|0.19|0.55|||Generalized Linear Model||||
1665628|NCT01457924|3064968|Superiority or Other||Ratio|0.51|||<|0.035|2-Sided|95.0|0.27|0.95|||Generalized Linear Model||||
1665629|NCT01457924|3064968|Superiority or Other||Ratio|0.56|||<|0.075|2-Sided|95.0|0.29|1.06|||Generalized Linear Model||||
1665630|NCT01457924|3064968|Superiority or Other||Ratio|0.31|||<|0.001|2-Sided|95.0|0.16|0.6|||Generalized Linear Model||||
1665631|NCT01457924|3064971|Superiority or Other||Ratio|0.23|||<|0.001|2-Sided|95.0|0.13|0.39|||Generalized Linear Model||||
1665632|NCT01457924|3064971|Superiority or Other||Ratio|0.35|||<|0.001|2-Sided|95.0|0.19|0.65|||Generalized Linear Model||||
1665633|NCT01457924|3064971|Superiority or Other||Ratio|0.38|||<|0.003|2-Sided|95.0|0.2|0.72|||Generalized Linear Model||||
1665634|NCT01457924|3064971|Superiority or Other||Ratio|0.38|||<|0.003|2-Sided|95.0|0.2|0.72|||Generalized Linear Model||||
1665635|NCT01457924|3064972|Superiority or Other||Ratio|0.35|||<|0.001|2-Sided|95.0|0.221|0.548|||Non-Linear Emax Model||||
1665638|NCT01457924|3064972|Superiority or Other||Ratio|0.35|||<|0.001|2-Sided|95.0|0.221|0.548|||Non-Linear Emax Model|||Note: There is a discrepancy in the number of par. in ITT populations at Wk 24 and Wk 48: 228 and 229 respectively. This resulted from a data issue: one par was incorrectly excluded from ITT pop. at Wk 24, but correctly included in Wk 48. This error affects all source tables, analyses relating to ITT and per protocol populations, primary endpoint and secondary MRI endpoints reported at Wk 24. This discrepancy affects all statistical analyses, but not summary statistics.|
1665639|NCT01457846|3064978|Superiority or Other||Odds Ratio (OR)|0.09||||0.997|2-Sided|80.0|0.02|0.35||1-sided|Regression, Logistic||||
1665640|NCT01457846|3064979|Superiority or Other||Hazard Ratio (HR)|1.31||||0.8156|2-Sided|80.0|0.89|1.95||1-sided|Regression, Cox||||
1665641|NCT01457846|3064980|Superiority or Other||Hazard Ratio (HR)|1.57||||0.9581|2-Sided|80.0|1.12|2.21||1-sided|Regression, Cox||||
1665642|NCT01457352|3065011|Superiority|||||||0.0485|||||||Mantel Haenszel||||
1665643|NCT01457352|3065012|Superiority|||||||0.2062|||||||Cochran-Mantel-Haenszel||||
1665644|NCT01457014|3065102|Superiority or Other|||||||0.161|||||||Wilcoxon (Mann-Whitney)||||
1665645|NCT01457014|3065103|Superiority or Other|||||||0.627||||||p value has undergone Bonferroni adjustment. P-Value applies to Av. 02 saturation|Wilcoxon (Mann-Whitney)|p value has undergone Bonferroni adjustment|||
1665646|NCT01457014|3065104|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|p values have undergone Bonferroni adjustment for Central Apnea Index (CAI), Obstructive Apnea Index (OAI) and Hypopnea Index (HI)|||
1665647|NCT01456962|3065105|Superiority or Other||% change in CD4+:CD8+ T cells ratio|-9.5||||0.4|2-Sided|95.0|-27.3|12.0|||Regression, Linear|Adjusted for treatment group and time on antiretroviral therapy|Change based on a 1 log unit increase in genital:plasma drug ratio|Null hypothesis: Higher genital to plasma antiretroviral drug ratios are not associated with higher cervical CD4+:CD8+ T cell ratios.|
1665648|NCT01456962|3065105|Superiority or Other|||||||0.6|||||||t-test, 2 sided||||
1665649|NCT01456949|3065106|Other|Secondary analyses were exploratory. No formal hypotheses or performance criteria were predefined.|||||||||||||||||Chronic treatment success was estimated at one and two years using Kaplan-Meier methods.
1665650|NCT01456949|3065107|Other|Secondary analyses were exploratory. No formal hypotheses or performance criteria were predefined.|||||||||||||||||Freedom from MAFE's was estimated using Kaplan-Meier methods.
1665651|NCT01456949|3065108|Superiority||Kaplan-Meier (product-limit) estimator|2.3|||<|0.001|2-Sided|95.0|1.1|4.5|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.|||
1665652|NCT01456949|3065109|Superiority||Kaplan-Meier (product-limit) estimator|66.9|||<|0.001|2-Sided|95.0|61.6|71.7|||Exact binomial|Exact binomial p-value is shown, but the confidence intervals reported are calculated from Greenwood's approximation of the standard error.|||
1665653|NCT01456936|3065113|Superiority or Other||Odds Ratio (OR)|1.81|||<|0.0001|2-Sided|95.0|1.49|2.19||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.|
1665654|NCT01456936|3065113|Superiority or Other||Odds Ratio (OR)|1.89|||<|0.0001|2-Sided|95.0|1.56|2.29||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.|
1665655|NCT01456936|3065113|Superiority or Other||Odds Ratio (OR)|2.74|||<|0.0001|2-Sided|95.0|2.28|3.3||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.|
1665656|NCT01456936|3065114|Superiority or Other||Odds Ratio (OR)|1.65|||<|0.0001|2-Sided|95.0|1.24|2.2||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.|
1665657|NCT01456936|3065114|Superiority or Other||Odds Ratio (OR)|1.77|||<|0.0001|2-Sided|95.0|1.33|2.36||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.|
1665658|NCT01456936|3065114|Superiority or Other||Odds Ratio (OR)|2.5|||<|0.0001|2-Sided|95.0|1.9|3.29||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.|
1665659|NCT01456936|3065115|Superiority or Other||Odds Ratio (OR)|1.96|||<|0.0001|2-Sided|95.0|1.51|2.54||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.|
1665660|NCT01456936|3065115|Superiority or Other||Odds Ratio (OR)|2.0|||<|0.0001|2-Sided|95.0|1.54|2.59||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.|
1665661|NCT01456936|3065115|Superiority or Other||Odds Ratio (OR)|2.99|||<|0.0001|2-Sided|95.0|2.33|3.83||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.|
1665662|NCT01456936|3065116|Superiority or Other||Odds Ratio (OR)|2.15|||<|0.0001|2-Sided|95.0|1.82|2.54||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.|
1665663|NCT01456936|3065116|Superiority or Other||Odds Ratio (OR)|2.07|||<|0.0001|2-Sided|95.0|1.75|2.45||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.|
1665664|NCT01456936|3065116|Superiority or Other||Odds Ratio (OR)|3.61|||<|0.0001|2-Sided|95.0|3.07|4.24||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.|
1665665|NCT01456936|3065117|Superiority or Other||Odds Ratio (OR)|2.0|||<|0.0001|2-Sided|95.0|1.56|2.55||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.|
1665666|NCT01456936|3065117|Superiority or Other||Odds Ratio (OR)|1.87|||<|0.0001|2-Sided|95.0|1.46|2.39||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.|
1665667|NCT01456936|3065117|Superiority or Other||Odds Ratio (OR)|3.24|||<|0.0001|2-Sided|95.0|2.56|4.11||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.|
1665668|NCT01456936|3065118|Superiority or Other||Odds Ratio (OR)|2.3|||<|0.0001|2-Sided|95.0|1.83|2.9||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.|
1665669|NCT01456936|3065118|Superiority or Other||Odds Ratio (OR)|2.26|||<|0.0001|2-Sided|95.0|1.8|2.85||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.|
1665670|NCT01456936|3065118|Superiority or Other||Odds Ratio (OR)|4.0|||<|0.0001|2-Sided|95.0|3.2|5.0||No multiplicity adjustment.|Regression, Logistic|||The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.|
1665671|NCT01456936|3065133|Superiority or Other||Risk Difference (RD)|0.37|||||2-Sided|95.0|-1.53|2.26|||||Risk difference for NRT versus placebo from estimation model.|Psychiatric cohort|
1665672|NCT01456936|3065133|Superiority or Other||Risk Difference (RD)|1.78|||||2-Sided|95.0|-0.24|3.81|||||Risk difference for bupropion 150 mg BID versus placebo from estimation model.|Psychiatric cohort|
1665673|NCT01456936|3065133|Superiority or Other||Risk Difference (RD)|1.59|||||2-Sided|95.0|-0.42|3.59|||||Risk difference for varenicline versus placebo from estimation model|Psychiatric cohort|
1665674|NCT01456936|3065133|Superiority or Other||Risk Difference (RD)|-0.21|||||2-Sided|95.0|-1.54|1.12|||||Risk difference for NRT versus placebo from estimation model.|Non-psychiatric cohort|
1665675|NCT01456936|3065133|Superiority or Other||Risk Difference (RD)|-0.08|||||2-Sided|95.0|-1.37|1.21|||||Risk difference for bupropion 150 mg BID versus placebo from estimation model.|Non-psychiatric cohort|
1665676|NCT01456936|3065133|Superiority or Other||Risk Difference (RD)|-1.28|||||2-Sided|95.0|-2.4|-0.15|||||Risk difference for varenicline versus placebo from estimation model.|Non-psychiatric cohort|
1665677|NCT01456936|3065134|Superiority or Other|||||||0.0652||||||An interaction between treatment and cohort was considered significant at 10% level. No multiplicity adjustments were utilized.|Regression, Linear|A generalized linear regression analysis based on the safety analysis set was used to evaluate incidence of NPS AE as the primary analysis.||The reduced (final) statistical model included treatment group, cohort and region, plus the 2-way interaction of treatment by cohort. Other interactions not included due to lack of significance. Region reduced to 2-level to address event sparseness issue.|
1665678|NCT01456195|3065156|Superiority or Other||LS Mean Difference|-30.0|Standard Error of the Mean|17.7||0.096|2-Sided|95.0|-65.5|5.5||ANCOVA model with treatment and country as fixed factors and baseline value as covariate.|ANCOVA||||
1665679|NCT01456195|3065156|Superiority or Other||LS Mean Difference|-28.8|Standard Error of the Mean|17.17||0.1|2-Sided|95.0|-63.2|5.7||ANCOVA model with treatment and country as fixed factors and baseline value as covariate.|ANCOVA||||
1665680|NCT01456195|3065157|Superiority or Other||LS Mean Difference|-22.3|Standard Error of the Mean|4.6|<|0.001|2-Sided|95.0|-31.4|-13.2||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements||||
1665681|NCT01456195|3065157|Superiority or Other||LS Mean Difference|-13.7|Standard Error of the Mean|4.59|<|0.003|2-Sided|95.0|-22.7|-4.6||Mixed Model Repeated Measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements||||
1665682|NCT01456195|3065158|Superiority or Other||Odds Ratio (OR)|4.4|||<|0.001|2-Sided|95.0|2.48|7.82||P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.|Regression, Logistic||||
1665683|NCT01456195|3065158|Superiority or Other||Odds Ratio (OR)|2.13|||<|0.01|2-Sided|95.0|1.2|3.79||P-Value used a logistic model with treatment, country and baseline HbA1c as explanatory variables.|Regression, Logistic||||
1665684|NCT01456195|3065159|Superiority or Other||LS Mean Difference|-0.76|Standard Error of the Mean|0.122|<|0.001|2-Sided|95.0|-1.0|-0.52||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements||||
1665685|NCT01456195|3065159|Superiority or Other||LS Mean Difference|-0.48|Standard Error of the Mean|0.122|<|0.001|2-Sided|95.0|-0.72|-0.24||MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with baseline value and baseline value by visit interaction as covariates with an unstructured covariance structure.|Mixed model for repeated measurements||||
1665686|NCT01456169|3065174|Superiority or Other||LS mean difference|-9.5|||<|0.001|2-Sided|95.0|-12.4|-6.5|||ANCOVA|ANCOVA model with treatment as a fixed effect and baseline trough, sitting, clinic SBP as a covariate|||
1665687|NCT01456169|3065174|Superiority or Other||LS mean difference|-14.7|||<|0.001|2-Sided|95.0|-17.6|-11.8|||ANCOVA|ANCOVA model with treatment as a fixed effect and baseline trough, sitting, clinic SBP as a covariate.||The type I error was controlled using a 2-step hierarchical testing procedure. In the first step, the high dose (40/25 mg) of Azilsartan medoxomil + chlorthalidone was compared to Azilsartan medoxomil alone. If the comparison in step 1 was statistically significant at a significance level of 5%, then step 2 was performed by comparing the low dose (40/12.5 mg) and monotherapy at the 5% significance level.|
1665688|NCT01456039|3065211|Superiority or Other||||||<|0.0001||||||Based on one sample binomial test for dichotomized response proportion against the null hypothesis ( H0 p≤0.1)|Binomial test for dichotomized response||||
1665689|NCT01455545|3065214|Superiority or Other||Odds Ratio (OR)|0.35||||0.013|2-Sided|95.0|0.153|0.799|||Regression, Logistic|||Ho = no differences between both groups H1= there are differences between both groups.|
1665690|NCT01455545|3065215|Superiority or Other||Odds Ratio (OR)|1.038||||0.005|2-Sided|95.0|1.012|1.065|||Regression, Logistic||||
1665691|NCT01455545|3065215|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1665692|NCT01455545|3065216|Superiority or Other||Odds Ratio (OR)|1.096||||0.822|2-Sided|95.0|0.492|2.441|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Comparison of two proportions. Unilateral test. (1-alpha)=95%. Proportion: 90%. Precision: 10%. Sample size: 35. Sample size adjusted to losses: 41 patients.|
1665693|NCT01455545|3065217|Superiority or Other||Odds Ratio (OR)|3.135||||0.15|2-Sided|95.0|0.618|15.91|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.|
1665694|NCT01455545|3065218|Superiority or Other||Odds Ratio (OR)|1.849||||0.196|2-Sided|95.0|1.541|2.219|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.|
1665695|NCT01455545|3065219|Superiority or Other||Odds Ratio (OR)|0.19||||0.107|2-Sided|95.0|0.02|1.763|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.|
1665696|NCT01455545|3065220|Superiority or Other||Odds Ratio (OR)|0.556||||0.155|2-Sided|95.0|0.247|1.253|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi squared test.|
1665697|NCT01455545|3065221|Superiority or Other||Odds Ratio (OR)|0.83||||0.643|2-Sided|95.0|0.376|1.829|||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Cross tabs Chi square|
1665698|NCT01455545|3065222|Superiority or Other|||||||0.217|||||||Chi-squared|||Ho = no differences between both groups H1= there are differences between both groups. Chi - square|
1665699|NCT01455545|3065223|Superiority or Other||Odds Ratio (OR)|1.625||||0.252|2-Sided|95.0|0.706|3.739|||Chi-squared|||Ho = no differences in gender results between both groups H1= there are differences between both groups. Cross tab Chi square|
1665700|NCT01455545|3065224|Superiority or Other||Odds Ratio (OR)|1.001||||0.861|2-Sided|95.0|0.985|1.018|||Regression, Logistic||||
1665701|NCT01455545|3065225|Superiority or Other||Odds Ratio (OR)|0.999||||0.967|2-Sided|95.0|0.962|1.037|||Regression, Logistic|||Ho = no differences in ASK-20 results between both groups H1= there are differences between both groups. Comparison of two means. Unilateral test. (1-alpha)=95%. Statistic power: 90%. Precision: 10. S square: 256. Sample size: 44. Sample size adjusted to losses: 46 patients.|
1665702|NCT01455428|3065239|Superiority or Other||Least Squares Mean Difference|-0.1|Standard Error of the Mean|0.285||0.7247|2-Sided|95.0|-0.66|0.46||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.|
1665703|NCT01455428|3065240|Superiority or Other||Least Squares Mean Difference|-0.21|Standard Error of the Mean|0.315||0.506|2-Sided|95.0|-0.83|0.41||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis was performed using a general linear model with treatment and center as factors, and the baseline value as a covariate.|
1665704|NCT01455428|3065242|Superiority or Other||Least Squares Mean Difference|-0.49|Standard Error of the Mean|0.113|<|0.0001|2-Sided|95.0|-0.72|-0.27||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis was performed using a general linear model with treatment and center as factors.|
1665705|NCT01455428|3065243|Superiority or Other||Least Squares Mean Difference|-0.62|Standard Error of the Mean|0.118|<|0.0001|2-Sided|95.0|-0.86|-0.39||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis was performed using a general linear model with treatment and center as factors.|
1665706|NCT01455428|3065244|Superiority or Other||Least Squares Mean Difference|-2.84|Standard Error of the Mean|1.92||0.1403|2-Sided|95.0|-6.63|0.94||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.|
1665707|NCT01455428|3065245|Superiority or Other||Least Squares Mean Difference|0.87|Standard Error of the Mean|2.194||0.6929|2-Sided|95.0|-3.46|5.2||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.|
1665708|NCT01455428|3065246|Superiority or Other||Least Squares Mean Difference|1.8|Standard Error of the Mean|3.161||0.5702|2-Sided|95.0|-4.44|8.03||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.|
1665709|NCT01455428|3065247|Superiority or Other||Odds Ratio (OR)|1.8||||0.0972|2-Sided|95.0|0.9|3.6||Analysis was two-sided and performed at the 0.05 significance level.|Regression, Logistic|||Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.|
1665710|NCT01455428|3065248|Superiority or Other||Least Squares Mean Difference|0.43|Standard Error of the Mean|0.147||0.0035|2-Sided|95.0|0.14|0.72||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.|
1665711|NCT01455428|3065249|Superiority or Other||Least Squares Mean Difference|-0.36|Standard Error of the Mean|2.579||0.8892|2-Sided|95.0|-5.45|4.73||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.|
1665712|NCT01455428|3065250|Superiority or Other||Least Squares Mean Difference|1.73|Standard Error of the Mean|2.783||0.5351|2-Sided|95.0|-3.76|7.22||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.|
1665713|NCT01455428|3065251|Superiority or Other||Least Squares Mean Difference|-7.21|Standard Error of the Mean|2.464||0.0039|2-Sided|95.0|-12.08|-2.35||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.|
1665714|NCT01455428|3065253|Superiority or Other||Least Squares Mean Difference|-0.37|Standard Error of the Mean|0.107||0.0007|2-Sided|95.0|-0.58|-0.16||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.|
1665715|NCT01455428|3065254|Superiority or Other||Least Squares Mean Difference|-8.18|Standard Error of the Mean|1.932|<|0.0001|2-Sided|95.0|-11.99|-4.37||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.|
1665716|NCT01455428|3065257|Superiority or Other|||||||0.0007||||||Analysis was two-sided and performed at the 0.05 significance level|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.|
1665717|NCT01455428|3065258|Superiority or Other||Least Squares Mean Difference|-0.47|Standard Error of the Mean|0.176||0.0081|2-Sided|95.0|-0.81|-0.12||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665718|NCT01455428|3065258|Superiority or Other||Least Squares Mean Difference|-0.48|Standard Error of the Mean|0.175||0.0062|2-Sided|95.0|-0.83|-0.14||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665719|NCT01455428|3065258|Superiority or Other||Least Squares Mean Difference|-0.39|Standard Error of the Mean|0.175||0.026|2-Sided|95.0|-0.74|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665720|NCT01455428|3065258|Superiority or Other||Least Squares Mean Difference|-0.39|Standard Error of the Mean|0.175||0.0258|2-Sided|95.0|-0.73|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665721|NCT01455428|3065258|Superiority or Other||Least Squares Mean Difference|-0.45|Standard Error of the Mean|0.174||0.0101|2-Sided|95.0|-0.79|-0.11||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665722|NCT01455428|3065258|Superiority or Other||Least Squares Mean Difference|-0.57|Standard Error of the Mean|0.173||0.0012|2-Sided|95.0|-0.91|-0.22||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665723|NCT01455428|3065258|Superiority or Other||Least Squares Mean Difference|-0.65|Standard Error of the Mean|0.173||0.0002|2-Sided|95.0|-0.99|-0.31||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665724|NCT01455428|3065258|Superiority or Other||Least Squares Mean Difference|-0.52|Standard Error of the Mean|0.172||0.0024|2-Sided|95.0|-0.86|-0.19||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665725|NCT01455428|3065259|Superiority or Other||Least Squares Mean Difference|-0.54|Standard Error of the Mean|0.2||0.0079|2-Sided|95.0|-0.93|-0.14||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.|
1665726|NCT01455428|3065261|Superiority or Other||Least Squares Mean Difference|-0.7|Standard Error of the Mean|0.154|<|0.0001|2-Sided|95.0|-1.0|-0.4||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665727|NCT01455428|3065261|Superiority or Other||Least Squares Mean Difference|-0.71|Standard Error of the Mean|0.154|<|0.0001|2-Sided|95.0|-1.01|-0.41||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665728|NCT01455428|3065261|Superiority or Other||Least Squares Mean Difference|-0.59|Standard Error of the Mean|0.153|<|0.0001|2-Sided|95.0|-0.89|-0.29||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665729|NCT01455428|3065261|Superiority or Other||Least Squares Mean Difference|-0.51|Standard Error of the Mean|0.153|<|0.0009|2-Sided|95.0|-0.81|-0.21||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665730|NCT01455428|3065261|Superiority or Other||Least Squares Mean Difference|-0.51|Standard Error of the Mean|0.152|<|0.0009|2-Sided|95.0|-0.81|-0.21||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665731|NCT01455428|3065261|Superiority or Other||Least Squares Mean Difference|-0.58|Standard Error of the Mean|0.151|<|0.0001|2-Sided|95.0|-0.88|-0.29||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665732|NCT01455428|3065261|Superiority or Other||Least Squares Mean Difference|-0.65|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-0.94|-0.35||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665733|NCT01455428|3065261|Superiority or Other||Least Squares Mean Difference|-0.49|Standard Error of the Mean|0.149|<|0.001|2-Sided|95.0|-0.79|-0.2||All analyses were 2-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1665734|NCT01455428|3065262|Superiority or Other||Least Squares Mean Difference|-0.71|Standard Error of the Mean|0.188||0.0002|2-Sided|95.0|-1.08|-0.34||Primary analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|||Analysis performed using a general linear model with treatment and center as factors, and baseline value as a covariate.|
1665735|NCT01455415|3065264|Superiority or Other|||||||0.1511||||||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Cochran-Mantel-Haenszel|||Analysis was done using a CMH test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.|
1665736|NCT01455415|3065265|Superiority or Other||Mean Difference (Final Values)|-0.038|Standard Error of the Mean|0.106||0.7174|2-Sided|95.0|-0.248|0.171||Primary analysis was two-sided and performed at the 0.05 significance level.|Repeated measure mixed effects model|The Kenward-Roger method was used to estimate denominator degrees of freedom.||A longitudinal analysis was done using a repeated measure linear mixed effects model including visit, treatment, an indicator variable for Week 6, and treatment by visit and by the indicator variable interaction as fixed effect factors and participant within sequence and within-participant error (estimated by using an unstructured covariance structure) as random factors. The treatment differences were tested using within-participant variability as the error term.|
1665737|NCT01455415|3065266|Superiority or Other|||||||0.0604||||||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Cochran-Mantel-Haenszel|||Analysis was done using a Cochran-Mantel-Haenszel (CMH) test with modified ridit transformation, under alternative hypothesis of raw mean scores differ.|
1665738|NCT01455415|3065267|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.01||0.5505|2-Sided|95.0|-0.04|0.02||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline Dolan 2001 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665739|NCT01455415|3065268|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.01||0.4279|2-Sided|95.0|-0.04|0.02||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline Dolan 1997 index summary score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665740|NCT01455415|3065269|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.03||0.1297|2-Sided|95.0|-0.11|0.01||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline anxiety / depression domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665741|NCT01455415|3065270|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.03||0.1495|2-Sided|95.0|-0.02|0.11||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline pain / discomfort domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665780|NCT01455194|3065299|Superiority or Other||Hazard Ratio (HR)|1.042|Standard Error of the Mean|0.0806||0.6062|2-Sided|95.0|0.89|1.221|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|Well-controlled Asthma|
1665781|NCT01455194|3065300|Superiority or Other|||||||0.8922|||||||Fisher Exact|||ACQ Improvement|
1665782|NCT01455194|3065300|Superiority or Other|||||||0.486|||||||Fisher Exact|||ACQ Improvement|
1665783|NCT01455194|3065300|Superiority or Other|||||||0.3305|||||||Fisher Exact|||ACQ Improvement|
1665742|NCT01455415|3065271|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.03||0.5497|2-Sided|95.0|-0.04|0.08||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline usual activities domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665743|NCT01455415|3065272|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.02||0.9726|2-Sided|95.0|-0.05|0.05||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline self-care domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665744|NCT01455415|3065273|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.03||0.9951|2-Sided|95.0|-0.05|0.05||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline mobility domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665745|NCT01455415|3065274|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.12||0.269|2-Sided|95.0|-0.38|0.11||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline autonomic domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665746|NCT01455415|3065275|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.16||0.9653|2-Sided|95.0|-0.31|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline small fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665747|NCT01455415|3065276|Superiority or Other||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.62||0.4335|2-Sided|95.0|-1.72|0.74||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline physical functioning / large fiber domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665748|NCT01455415|3065277|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.18||0.5119|2-Sided|95.0|-0.48|0.24||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline activities of daily living domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665749|NCT01455415|3065278|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.26||0.1769|2-Sided|95.0|-0.85|0.16||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline symptoms domain score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665750|NCT01455415|3065279|Superiority or Other||Mean Difference (Final Values)|-1.08|Standard Error of the Mean|1.04||0.2987|2-Sided|95.0|-3.13|0.96||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline total score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665751|NCT01455415|3065280|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.17||0.6007|2-Sided|95.0|-0.42|0.24||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline HADS-D score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665752|NCT01455415|3065281|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.18||0.7344|2-Sided|95.0|-0.42|0.3||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline HADS-A score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665753|NCT01455415|3065282|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.11||0.0272|2-Sided|95.0|-0.44|-0.03||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using linear mixed effects model including baseline score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors.|
1665754|NCT01455415|3065283|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.12||0.4548|2-Sided|95.0|-0.32|0.14||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline interference score, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665755|NCT01455415|3065284|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.11||0.9448|2-Sided|95.0|-0.21|0.22||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Mixed Models Analysis|||Analysis was done using a linear mixed effects model which included baseline pain severity, sequence, period, and treatment as fixed effect factors and participant within sequence and within-participant error as random factors. The treatment difference (pregabalin - placebo) has been tested using within-participant variability as error term.|
1665756|NCT01455415|3065285|Superiority or Other||Odds Ratio (OR)|1.57||||0.0625|2-Sided|95.0|0.98|2.51||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Regression, Logistic|||Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.|
1665757|NCT01455415|3065286|Superiority or Other||Odds Ratio (OR)|1.2||||0.3287|2-Sided|95.0|0.83|1.73||Secondary analysis was two-sided and performed at the 0.05 significance level, without multiple comparisons' adjustment.|Regression, Logistic|||Analysis was done using a logistic regression model which included baseline pain, sequence, period and treatment as covariate.|
1665758|NCT01455194|3065296|Superiority or Other|||||||0.2864|||||||Fisher Exact||||
1665759|NCT01455194|3065296|Superiority or Other|||||||0.288|||||||Fisher Exact||||
1665760|NCT01455194|3065297|Superiority or Other||Hazard Ratio (HR)|0.882|Standard Error of the Mean|0.4365||0.7732|2-Sided|95.0|0.375|2.074|||Log Rank||A hazard ratio of <1 represented a benefit for the test treatment.||
1665761|NCT01455194|3065297|Superiority or Other||Hazard Ratio (HR)|2.102|Standard Error of the Mean|0.5001||0.1373|2-Sided|95.0|0.789|5.602|||Log Rank||A hazard ratio of <1 represented a benefit for the test treatment.||
1665762|NCT01455194|3065297|Superiority or Other||Hazard Ratio (HR)|1.367|Standard Error of the Mean|0.2583||0.2264|2-Sided|95.0|0.824|2.267|||Log Rank||A hazard ratio of <1 represented a benefit for the test treatment.||
1665763|NCT01455194|3065298|Superiority or Other||Hazard Ratio (HR)|1.047|Standard Error of the Mean|0.1375||0.7367|2-Sided|95.0|0.8|1.371|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ cut-off at 1.5|
1665764|NCT01455194|3065298|Superiority or Other||Hazard Ratio (HR)|0.992|Standard Error of the Mean|0.1408||0.9564|2-Sided|95.0|0.753|1.308|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ cut-off at 1.25|
1665765|NCT01455194|3065298|Superiority or Other||Hazard Ratio (HR)|0.939|Standard Error of the Mean|0.1461||0.6645|2-Sided|95.0|0.705|1.25|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ cut-off at 1.0|
1665766|NCT01455194|3065298|Superiority or Other||Hazard Ratio (HR)|0.837|Standard Error of the Mean|0.1744||0.308|2-Sided|95.0|0.595|1.178|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ cut-off at 0.5|
1665767|NCT01455194|3065298|Superiority or Other||Hazard Ratio (HR)|1.055|Standard Error of the Mean|0.1388||0.6995|2-Sided|95.0|0.804|1.385|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ cut-off at 1.5|
1665768|NCT01455194|3065298|Superiority or Other||Hazard Ratio (HR)|1.059|Standard Error of the Mean|0.1415||0.6853|2-Sided|95.0|0.803|1.397|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ cut-off at 1.25|
1665769|NCT01455194|3065298|Superiority or Other||Hazard Ratio (HR)|1.074|Standard Error of the Mean|0.1467||0.6281|2-Sided|95.0|0.805|1.431|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ cut-off at 1.0|
1665770|NCT01455194|3065298|Superiority or Other||Hazard Ratio (HR)|1.326|Standard Error of the Mean|0.1791||0.115|2-Sided|95.0|0.934|1.884|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ cut-off at 0.5|
1665771|NCT01455194|3065298|Superiority or Other||Hazard Ratio (HR)|1.05|Standard Error of the Mean|0.0692||0.4807|2-Sided|95.0|0.917|1.202|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ cut-off at 1.5|
1665772|NCT01455194|3065298|Superiority or Other||Hazard Ratio (HR)|1.026|Standard Error of the Mean|0.0708||0.7213|2-Sided|95.0|0.893|1.178|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ cut-off at 1.25|
1665773|NCT01455194|3065298|Superiority or Other||Hazard Ratio (HR)|1.005|Standard Error of the Mean|0.0738||0.9458|2-Sided|95.0|0.87|1.161|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ cut-off at 1.0|
1665774|NCT01455194|3065298|Superiority or Other||Hazard Ratio (HR)|1.058|Standard Error of the Mean|0.0917||0.5397|2-Sided|95.0|0.884|1.266|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ cut-off at 0.5|
1665775|NCT01455194|3065299|Superiority or Other||Hazard Ratio (HR)|1.181|Standard Error of the Mean|0.1351||0.2193|2-Sided|95.0|0.906|1.538|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ Improvement|
1665776|NCT01455194|3065299|Superiority or Other||Hazard Ratio (HR)|0.898|Standard Error of the Mean|0.156||0.4893|2-Sided|95.0|0.661|1.219|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|Well-controlled Asthma|
1665777|NCT01455194|3065299|Superiority or Other||Hazard Ratio (HR)|0.913|Standard Error of the Mean|0.1354||0.5026|2-Sided|95.0|0.7|1.191|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ Improvement|
1665778|NCT01455194|3065299|Superiority or Other||Hazard Ratio (HR)|1.201|Standard Error of the Mean|0.1597||0.2523|2-Sided|95.0|0.878|1.642|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|Well-controlled Asthma|
1665779|NCT01455194|3065299|Superiority or Other||Hazard Ratio (HR)|1.05|Standard Error of the Mean|0.0669||0.4674|2-Sided|95.0|0.921|1.197|||Log Rank||A hazard ratio of >1 represented a benefit for the test treatment.|ACQ Improvement|
1665784|NCT01455194|3065300|Superiority or Other|||||||0.6017|||||||Fisher Exact|||Well-controlled Asthma|
1665787|NCT01455194|3065301|Superiority or Other||Hodges-Lehmann point estimate|1.0||||0.4175|2-Sided|95.0|-2.0|5.0|||Wilcoxon (Mann-Whitney)||Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.||
1665788|NCT01455194|3065301|Superiority or Other||Hodges-Lehmann point estimate|0.0||||0.8465|2-Sided|95.0|-3.0|4.0|||Wilcoxon (Mann-Whitney)||Treatment comparisons were carried out using an exact Wilcoxon Mann Whitney test.||
1665789|NCT01455194|3065303|Superiority or Other||LS Mean Difference|-0.156|Standard Error of the Mean|0.1172||0.1835|2-Sided|95.0|-0.387|0.074|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.|
1665790|NCT01455194|3065303|Superiority or Other||LS Mean Difference|0.034|Standard Error of the Mean|0.118||0.7741|2-Sided|95.0|-0.198|0.266|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.|
1665791|NCT01455194|3065303|Superiority or Other||LS Mean Difference|-0.122|Standard Error of the Mean|0.1175||0.2988|2-Sided|95.0|-0.353|0.109|||ANCOVA|||Least square (LS) mean difference were derived from an ANCOVA model with baseline ACQ and age as covariates, and treatment, centre pool, sex, and prestudy ICS dose as factors.|
1665792|NCT01455012|3065324|Superiority or Other||Mean Difference (Final Values)|-160.34|Standard Error of the Mean|26.46|<|0.0001|2-Sided|95.0|-213.23|-107.45||The analysis of this primary efficacy variable was performed using a two-sided alpha level of 5 %.|ANCOVA||The treatment effect was estimated on the basis of the Least Square Mean (LSM) of the difference as well as on the 95 % Confidence Interval and the p-value for that difference. Difference to Placebo was calculated as Rotigotine-Placebo.|The 95 % Confidence Interval (CI) and the p-value for the mean difference between Rotigotine and Placebo was obtained from a linear Analysis of Covariance (ANCOVA) model with fixed effects for treatment and Baseline antihypertensive use and a covariate for the Baseline number of nocturnal elevations of Systolic Blood Pressure that are associated with Periodic Limb Movements (PLMs).|
1665793|NCT01454934|3065327|Superiority or Other|||||||0.3034||||||The P-value was stratified by histology, TPC option, and geographic region.|Cochran-Mantel-Haenszel|||OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).|
1665794|NCT01454934|3065328|Superiority or Other||Hazard Ratio (HR)|1.09||||0.3946|2-Sided|95.0|0.9|1.32||P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.|Log Rank||The hazard ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option, and geographic region as strata.|OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).|
1665795|NCT01454934|3065329|Superiority or Other||Hazard Ratio (HR)|1.16||||0.1343|2-Sided|95.0|0.95|1.41||P-value was calculated from a 2-sided long-rank test stratified by histology, TPC option, and geographic region.|Log Rank||Hazard Ratio was based on a Cox regression model including treatment as covariate, and histology, TPC option and geographic region as strata.|OS was compared between eribulin and TPC testing the following null hypothesis: H0: OS in Arm A (eribulin) is equal to OS in Arm B (TPC) against the alternative: H1: OS in Arm A (eribulin) is not equal to OS in Arm B (TPC).|
1665796|NCT01454830|3065333|Superiority or Other||Mean Difference (Final Values)|-1.15|Standard Error of the Mean|4.09||0.78|2-Sided||||||t-test, 2 sided||units of measurement: % TST; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Exploratory outcome of PAP use defined within the sleep period, TST (total sleep time).|
1665797|NCT01454830|3065334|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.53||0.89|2-Sided||||||t-test, 2 sided||units of measurement: hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial|
1665798|NCT01454830|3065335|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.48||0.9|2-Sided||||||t-test, 2 sided||unit of measurement: hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial|
1665799|NCT01454830|3065336|Superiority or Other||Mean Difference (Final Values)|0.58|Standard Error of the Mean|0.44||0.2|2-Sided||||||t-test, 2 sided||unit of measurement, hours/night; positive estimation parameter favors TI group; negative estimation parameter favors UC group|Pilot RCT designed to establish effect size and feasibility outcomes; no a priori power calculation; statistical significance with hypotheses testing was not objective of the pilot trial|
1665800|NCT01454791|3065337|Superiority or Other||Mean Difference (Final Values)|0.18||||0.705|2-Sided||||||t-test, 2 sided||not significant||
1665801|NCT01454791|3065338|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.6059|2-Sided||||||t-test, 2 sided||not significant||
1665802|NCT01454791|3065339|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.45|2-Sided||||||t-test, 2 sided||||
1665803|NCT01454531|3065380|Superiority or Other||||||<|0.01|||||||Parallel Line Assay|||Parallel Line Assay is based on the construction of two dose-response regression lines obtained plotting the allergen concentration used to prick test the subjects against the wheal size obtained. ANOVA allows to check for regression, linearity and parallelism. A common slope and y-intercepts are calculated. The CTI is the exponentiation of the difference between y-intercepts divided by the common slope. (Finney D.J., Statistical Method in Biological Assay, 1978).|
1665804|NCT01454531|3065381|Superiority or Other||||||<|0.001||||||Paired samples|t-test, 2 sided|||The null hypothesis is no changes in Phleum specific IgG4 values from visit 1 (baseline) to visit 6 (end of treatment) versus the alternative hypothesis of change in Phleum specific IgG4 values|
1665805|NCT01454531|3065382|Superiority or Other||||||<|0.001||||||Paired values|t-test, 2 sided|||The null hypothesis is no changes in IgE-blocking factor values from visit 1 (baseline) to visit 6 (end of treatment) versus the alternative hypothesis of change in IgE-blocking factor values|
1665890|NCT01451814|3065712|Superiority or Other||Odds Ratio (OR)|3.0||||0.18|2-Sided|95.0|0.56|16.11|||Chi-squared||||
1665806|NCT01454414|3065390|Superiority or Other||Protective effectiveness= 1 - rate ratio|0.646||||0.004|2-Sided|95.0|0.288|0.824|||Poisson regression|||Protective effectiveness (1 – the incidence rate ratio) and 95% CIs for comparing reported tick bites between the treatment and control groups were calculated using a GEE model with a Poisson distribution and log link, and included terms for treatment, year of follow-up, and the interaction of treatment and year of follow-up, with an offset variable for log outdoor work hours.|
1665807|NCT01454362|3065393|Superiority|||||||0.003|||||||t-test, 2 sided||||
1665808|NCT01454362|3065394|Superiority|||||||0.001|||||||t-test, 2 sided||||
1665809|NCT01454362|3065395|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1665810|NCT01454362|3065396|Superiority|||||||0.43|||||||t-test, 2 sided||||
1665811|NCT01454362|3065397|Superiority|||||||0.17|||||||t-test, 2 sided||||
1665812|NCT01454063|3065434|Superiority or Other||||||<|0.0001||||||Generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel||||
1665813|NCT01454063|3065435|Superiority or Other|||||||0.0532||||||Treatment comparisons are based on generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel||||
1665814|NCT01454063|3065436|Superiority or Other|||||||0.0963||||||Treatment comparisons based on Wilcoxon rank-sum test stratified by randomization strata. For subjects without a score due to inability to read the ETDRS chart, the log score will be imputed as 1.6 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1665815|NCT01454063|3065437|Superiority or Other|||||||0.0034||||||Treatment comparisons based on CMH test adjusting for the randomization strata.|Cochran-Mantel-Haenszel||||
1665816|NCT01454063|3065438|Superiority or Other|||||||0.0514||||||Treatment comparisons based on CMH test adjusting for randomization strata.|Cochran-Mantel-Haenszel||||
1665817|NCT01454063|3065439|Superiority or Other||Mean Difference (Net)|-5.199|Standard Error of the Mean|1.076|<|0.0001||95.0|-7.307|-3.091||p-value based on the generalized CMH test stratified by randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS302-placebo) adjusted for randomization strata.|||
1665818|NCT01454063|3065440|Superiority or Other||Mean Difference (Final Values)|0.577|Standard Error of the Mean|0.052|<|0.0001||95.0|0.475|0.678||p-value based on the generalized Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata.|Cochran-Mantel-Haenszel|CMH-weighted mean difference (OMS - Placebo) adjusted for randomization strata.|||
1665819|NCT01453725|3065472|Superiority or Other||||||<|0.0001|||||||Mann-Whitney Test||||
1665820|NCT01453725|3065473|Superiority or Other||Difference in Percent vs Placebo|15.2||||0.0136|2-Sided|95.0|3.2|27.1||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method||||
1665821|NCT01453725|3065474|Superiority or Other||Difference in Percent vs Placebo|28.0|||<|0.0001|2-Sided|95.0|14.4|40.6||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method||||
1665822|NCT01453725|3065475|Superiority or Other||Difference in Percent vs Placebo|33.8|||<|0.0001|2-Sided|95.0|20.4|46.1||Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level|Stratified Miettinen and Nurminen Method||||
1665823|NCT01453725|3065476|Superiority or Other||Difference in Percent vs Placebo|31.2|||<|0.0001|2-Sided|95.0|17.5|43.6||Stratification factors: Baseline evidence of sacroiliitis on magnetic resonance imaging (MRI) and Screening C-reactive protein (CRP) level|Stratified Miettinen and Nurminen Method||||
1665824|NCT01453374|3065500|Superiority or Other||||||<|0.1|||||||Fisher Exact||||
1665825|NCT01453374|3065506|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1665826|NCT01453374|3065507|Superiority or Other||||||>|0.05|||||||Fisher Exact||||
1665827|NCT01453374|3065508|Superiority or Other||||||>|0.05|||||||Fisher Exact||||
1665828|NCT01453348|3065515|Non-Inferiority or Equivalence|(GMC anti-HBsAg + MenACWY-CRM / GMC anti-HBsAg)|Ratio of GMC|1.19|||||2-Sided|95.0|0.59|2.37||||||The primary criterion for immunogenicity was that the the lower-limit of the two-sided 95% CI on the ratio of ELISA GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.|
1665829|NCT01453348|3065515|Non-Inferiority or Equivalence|(GMC anti-HAV + MenACWY-CRM / GMC anti-HAV)|Ratio of GMC|0.89|||||2-Sided|95.0|0.6|1.32||||||The primary criterion for immunogenicity was that the lower-limit of the two-sided 95% Confidence Interval (CI) on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs (Hep A/B + MenACWY-CRM to Hep A/B) is below or equal to 0.5.|
1665830|NCT01453296|3065516|Superiority or Other||Mean Difference (Final Values)|3.19|||||2-Sided|95.0|-0.7|7.08|||||Day 14 weighted QTcF (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.||
1665831|NCT01453296|3065516|Superiority or Other||Mean Difference (Final Values)|2.94|||||2-Sided|95.0|-1.93|7.81|||||Day 14 weighted QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.||
1665832|NCT01453296|3065516|Superiority or Other||Mean Difference (Final Values)|2.01|||||2-Sided|95.0|-2.59|6.61|||||Day 1 weighted QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.||
1665833|NCT01453296|3065530|Superiority or Other||Mean Difference (Final Values)|1.3|||||2-Sided|95.0|-3.0|5.7|||||Day 14 maximum QTcF (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.||
1665834|NCT01453296|3065530|Superiority or Other||Mean Difference (Final Values)|1.6|||||2-Sided|95.0|-3.2|6.3|||||Day 14 maximum QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.||
1665835|NCT01453296|3065530|Superiority or Other||Mean Difference (Final Values)|1.0|||||2-Sided|95.0|-4.5|6.6|||||Day 1 maximum QTcF (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.||
1665836|NCT01453296|3065531|Superiority or Other||Mean Difference (Final Values)|0.5|||||2-Sided|95.0|-2.6|3.6|||||Day 14 weighted HR (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.||
1665837|NCT01453296|3065531|Superiority or Other||Mean Difference (Final Values)|0.6|||||2-Sided|95.0|-2.4|3.7|||||Day 14 weighted HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.||
1665838|NCT01453296|3065531|Superiority or Other||Mean Difference (Final Values)|2.5|||||2-Sided|95.0|-0.8|5.7|||||Day 1 weighted HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.||
1665839|NCT01453296|3065532|Superiority or Other||Mean Difference (Final Values)|0.5|||||2-Sided|95.0|-2.6|3.6|||||Day 14 maximum HR (0-8 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.||
1665840|NCT01453296|3065532|Superiority or Other||Mean Difference (Final Values)|0.6|||||2-Sided|95.0|-2.4|3.7|||||Day 14 maximum HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.||
1665841|NCT01453296|3065532|Superiority or Other||Mean Difference (Final Values)|2.5|||||2-Sided|95.0|-0.8|5.7|||||Day 1 maximum HR (0-2 hr). The estimated value represents the treatment difference: VI 25 µg minus placebo.||
1665842|NCT01453205|3065557|Superiority or Other|||||||0.1686|||||||Log Rank||||
1665843|NCT01453205|3065558|Superiority or Other|||||||0.9996|||||||Log Rank||||
1665844|NCT01453205|3065559|Superiority or Other|||||||0.7412|||||||Log Rank||||
1665845|NCT01453205|3065560|Superiority or Other|||||||0.8567|||||||Log Rank||||
1665846|NCT01453205|3065561|Superiority or Other|||||||0.5543|||||||Cochran-Mantel-Haenszel||||
1665847|NCT01453166|3065562|Superiority or Other||Mean Difference (Final Values)|100.0|Standard Deviation|30.0||0.05||95.0|77.0|137.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values <0.05. All analyzes were performed following the principle of intention to treat."|
1665848|NCT01453166|3065563|Superiority or Other||Mean Difference (Final Values)|100.0|Standard Deviation|12.0||0.05||95.0|88.0|112.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values <0.05. All analyzes were performed following the principle of intention to treat."|
1665849|NCT01453166|3065564|Superiority or Other||Mean Difference (Final Values)|170.0|Standard Deviation|39.0||0.05||95.0|140.0|220.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values <0.05. All analyzes were performed following the principle of intention to treat."|
1665850|NCT01453166|3065565|Superiority or Other||Mean Difference (Final Values)|78.0|Standard Deviation|15.0||0.05||95.0|66.0|95.0|||ANOVA||||
1665851|NCT01453166|3065566|Superiority or Other||Mean Difference (Final Values)|120.0|Standard Deviation|19.0|<|0.05||95.0|100.0|140.0|||ANOVA|||"The absolute changes has been assessed by ANOVA, in which the homogeneity of variance was assessed and the Brown-Forsythe correction was used when necessary. In cases of statistically significant differences between groups, we used multiple comparisons with Bonferroni adjustment to locate the differences. Was considered statistically significant p values <0.05. All analyzes were performed following the principle of intention to treat."|
1665852|NCT01453153|3065572|Superiority||percentage of participants|70.0|||||2-Sided|95.0|46.0|88.0|||||||
1665853|NCT01453153|3065572|Superiority||percentage of participants|100.0|||||2-Sided|95.0|40.0|100.0|||||||
1665854|NCT01453153|3065572|Superiority||percentage of participants|25.0|||||2-Sided|95.0|1.0|81.0|||||||
1665855|NCT01453153|3065573|Superiority||percentage of participants|40.0|||||2-Sided|95.0|19.0|64.0|||||||
1665856|NCT01453153|3065573|Superiority||percentage of participants|50.0|||||2-Sided|95.0|7.0|93.0|||||||
1665857|NCT01453153|3065573|Superiority||percentage of participants|0.0|||||2-Sided|95.0|0.0|60.0|||||||
1665858|NCT01453023|3065644|Superiority or Other||Mean Difference (Final Values)|-0.3|||||2-Sided|95.0|-6.0|5.5|||||Day 14 QTcF. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.||
1665859|NCT01453023|3065644|Superiority or Other||Mean Difference (Final Values)|1.2|||||2-Sided|95.0|-4.4|6.7|||||Day 1 QTcF. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.||
1665860|NCT01453023|3065645|Superiority or Other||Mean Difference (Final Values)|3.7|||||2-Sided|95.0|-1.1|8.5|||||Day 14 HR. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.||
1665861|NCT01453023|3065645|Superiority or Other||Mean Difference (Final Values)|-4.2|||||2-Sided|95.0|-8.8|0.4|||||Day 1 HR. The estimated value represents the treatment difference: FF/VI 100/25 µg minus FF 100 µg.||
1665862|NCT01452789|3065661|Superiority||||||<|0.05|||||||Cochran-Mantel-Haenszel||||
1665863|NCT01452789|3065662|Superiority||||||<|0.05|||||||van Elteren||||
1665864|NCT01452789|3065663|Superiority||||||<|0.05|||||||van Elteren||||
1665865|NCT01452347|3065676|Superiority or Other|||||||0.65||||||Probability that P remains < 10% are presented, where P=Percentage of patients with observed Ctrough,ss value < 50 ng/mL|Beta Function|Probability calculated using Beta function ~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value < 50 ng/mL), n=no. of patients evaluated|||
1665866|NCT01452347|3065677|Superiority or Other|||||||0.46||||||Probability that P remains < 10% are presented, where P=Percentage of patients with observed Ctrough,ss value < 50 ng/mL|Beta Function|Probability calculated using Beta function ~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value < 50 ng/mL), n=no. of patients evaluated|||
1665867|NCT01452347|3065678|Superiority or Other|||||||0.05||||||Probability that P remains < 10% are presented, where P=Percentage of patients with observed Ctrough,ss value < 50 ng/mL|Beta Function|Probability calculated using Beta function ~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value < 50 ng/mL), n=no. of patients evaluated|||
1665868|NCT01452347|3065679|Superiority or Other||||||<|0.001||||||Probability that P remains < 10% are presented, where P=Percentage of patients with observed Ctrough,ss value < 50 ng/mL|Beta Function|Probability calculated using Beta function ~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value < 50 ng/mL), n=no. of patients evaluated|||
1665891|NCT01451814|3065713|Superiority or Other||Odds Ratio (OR)|4.3||||0.06|2-Sided|95.0|0.84|22.1|||Chi-squared||||
1665892|NCT01451814|3065714|Superiority or Other||Odds Ratio (OR)|1.91||||0.22|2-Sided|95.0|0.67|5.48|||Chi-squared||||
1665869|NCT01452347|3065680|Superiority or Other||Adjusted Geometric Mean ratio|103.25|Standard Error of the Mean|1.11||||95.0|86.4|123.4|||||"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both > than the lower bound and < than the upper bound of the acceptance range [Note: The acceptance range for the geometric mean is 80-125%]"|
1665870|NCT01452347|3065681|Superiority or Other||Adjusted Geometric Mean ratio|95.5|Standard Error of the Mean|1.05||||95.0|88.69|102.84|||||"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both > than the lower bound and < than the upper bound of the acceptance range [Note: The acceptance range for the geometric mean is 80-125%]"|
1665871|NCT01452347|3065682|Superiority or Other||Adjusted Geometric Mean ratio|84.46|Standard Error of the Mean|1.11||||95.0|70.32|101.44|||||"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both > than the lower bound and < than the upper bound of the acceptance range [Note: The acceptance range for the geometric mean is 80-125%]"|
1665872|NCT01452347|3065683|Superiority or Other||Adjusted Geometric Mean ratio|74.22|Standard Error of the Mean|1.05||||95.0|68.08|80.91|||||"The standard error of the mean is actually the geometric standard error.~(Observed vs Predicted)"|"Null hypothesis: The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range .~Alternative hypothesis: The difference of the population average responses was both > than the lower bound and < than the upper bound of the acceptance range [Note: The acceptance range for the geometric mean is 80-125%]"|
1665873|NCT01451827|3065709|Superiority or Other||Ratio of geometric means|0.98||||0.2306|2-Sided|95.0|0.94|1.01|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo|
1665874|NCT01451827|3065709|Superiority or Other||Ratio of geometric means|0.96||||0.0298|2-Sided|95.0|0.93|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo|
1665875|NCT01451827|3065709|Superiority or Other||Ratio of geometric means|0.96||||0.0287|2-Sided|95.0|0.93|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo|
1665876|NCT01451827|3065709|Superiority or Other||Ratio of geometric means|0.97||||0.0209|2-Sided|95.0|0.94|0.99|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.|
1665877|NCT01451827|3065710|Superiority or Other||Mean Difference (Final Values)|1.23|||<|0.0001|2-Sided|95.0|0.8|1.66|||ANCOVA|||Nocturia|
1665878|NCT01451827|3065710|Superiority or Other||Median Difference (Final Values)|1.07|||<|0.0001|2-Sided|95.0|0.63|1.51|||ANCOVA|||Nocturia|
1665879|NCT01451827|3065710|Superiority or Other||Mean Difference (Final Values)|0.86|||<|0.0002|2-Sided|95.0|0.42|1.3|||ANCOVA|||Nocturia|
1665880|NCT01451827|3065710|Superiority or Other||Mean Difference (Final Values)|0.99|||<|0.0001|2-Sided|95.0|0.63|1.34|||ANCOVA|||Urinary Urgency|
1665881|NCT01451827|3065710|Superiority or Other||Mean Difference (Final Values)|0.65|||<|0.0004|2-Sided|95.0|0.29|1.01|||ANCOVA|||Urinary Urgency|
1665882|NCT01451827|3065710|Superiority or Other||Mean Difference (Final Values)|0.66|||<|0.0004|2-Sided|95.0|0.3|1.01|||ANCOVA|||Urinary Urgency|
1665883|NCT01451827|3065710|Superiority or Other||Mean Difference (Final Values)|0.92|||<|0.0001|2-Sided|95.0|0.58|1.25|||ANCOVA|||Urinary Frequency|
1665884|NCT01451827|3065710|Superiority or Other||Mean Difference (Final Values)|0.74|||<|0.0001|2-Sided|95.0|0.4|1.08|||ANCOVA|||Urinary Frequency|
1665885|NCT01451827|3065710|Superiority or Other||Mean Difference (Final Values)|0.65|||<|0.0002|2-Sided|95.0|0.31|0.99|||ANCOVA|||Urinary Frequency|
1665886|NCT01451827|3065711|Superiority or Other||Ratio of geometric means|0.99||||0.2417|2-Sided|95.0|0.97|1.01|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.|
1665887|NCT01451827|3065711|Superiority or Other||Ratio of geometric means|0.98||||0.0155|2-Sided|95.0|0.96|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.|
1665888|NCT01451827|3065711|Superiority or Other||Ratio of geometric means|0.97||||0.0108|2-Sided|95.0|0.95|0.99|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.|
1665889|NCT01451827|3065711|Superiority or Other||Ratio of geometric means|0.98||||0.0127|2-Sided|95.0|0.96|1.0|||ANCOVA|||Hierarchical tests were used to control the type I error in the primary analysis. They are given in the following order: 1. Pooled tolvaptan treatment groups (IR and MR) versus placebo; 2. Tolvaptan MR 80 mg versus placebo; 3. Tolvaptan MR 50 mg versus placebo; 4. Tolvaptan IR 60/30 mg versus placebo.|
1665893|NCT01451775|3065716|Non-Inferiority or Equivalence|This is an analysis of dose proportionality|Slope|0.9065|Standard Deviation|0.0495|||2-Sided|95.0|0.8011|1.012|||||||
1665894|NCT01451775|3065716|Non-Inferiority or Equivalence|Bioavailability study with standard bioequivalence range of 80% to 125%. Ratio calculated as empa 25mg fed divided by empa 25mg fasted.|Geometric mean ratio|63.22|Standard Deviation|18.1|||2-Sided|90.0|56.736|70.439|||||Standard deviation is actually the geometric coefficient of variation.||
1665895|NCT01451775|3065717|Non-Inferiority or Equivalence|This is an analysis of dose proportionality|Slope|0.9367|Standard Error of the Mean|0.0178|||2-Sided|95.0|0.8988|0.9746|||||||
1665896|NCT01451775|3065717|Non-Inferiority or Equivalence|Bioavailability study with standard bioequivalence range of 80% to 125%. Ratio calculated as empa 25mg fed divided by empa 25mg fasted.|Geometric mean ratio|84.04|Standard Deviation|6.4|||2-Sided|90.0|80.856|87.344|||||Standard deviation is actually the geometric coefficient of variation.||
1665897|NCT01451606|3065735|Superiority|||||||0.84|||||||t-test, 2 sided||||
1665898|NCT01451606|3065736|Superiority|||||||0.52||||||Note that sample size was well below our target, making this test very low power.|Wilcoxon (Mann-Whitney)||||
1665899|NCT01451554|3065737|Superiority or Other|||||||0.31|||||||t-test, 2 sided|||Data were compared between groups using a 2 sample T-test.|
1665900|NCT01451554|3065738|Superiority or Other|||||||0.06||||||2 tailed t-test|t-test, 2 sided|||Data were compared between groups using the 2 sample T-test.|
1665901|NCT01451541|3065750|Superiority or Other||LS Means with adjusted p-values.|0.47|||<|0.05||||||Multiple comparisons were adjusted for the primary and key secondary endpoints|Bonferroni-based gatekeeping method|Bonferroni-based gatekeeping method was used for multiple comparison adjustment.||Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).|
1665902|NCT01451541|3065750|Superiority or Other||LS Means with adjusted pvalues|0.59|||<|0.05||||||Multiple comparisons were adjusted for the primary and key secondary endpoints|Bonferroni-based gatekeeping method|Bonferroni-based gatekeeping method was used for multiple comparison adjustment.||Using an estimate of the standard deviation of 2.2 for the change from baseline in daily average subject-reported AM and PM rTNSS averaged over the first 6 weeks of double-blind treatment, 284 subjects per treatment group would have provided 90% power to detect a mean difference between treatment groups of 0.6 in the change from baseline with a 2-sided significance level of 0.05. Approx. 852 subjects were randomly assigned in a 1:1:1 ratio (ie, approximately 284 subjects per treatment group).|
1665903|NCT01451463|3065751|Superiority or Other|||||||0.114|||||||t-test, 2 sided||||
1665904|NCT01451463|3065752|Superiority or Other|||||||0.009|||||||t-test, 2 sided||||
1665905|NCT01451398|3065782|Superiority or Other||Mean Difference (Final Values)|1.62|Standard Error of the Mean|0.365|<|0.0001|2-Sided|95.0|0.9|2.34|||ANCOVA||Model: Baseline Weight + Change in HbA1c at Week 24 + Region + OAD Stratum + Treatment||
1665906|NCT01451398|3065785|Superiority or Other|||||||0.2024|||||||Negative Binomial Regression|Model: Treatment + Region + OAD Stratum + Exposure Time|||
1665907|NCT01451398|3065786|Superiority or Other||||||<|0.0001|||||||Negative binomial regression|Model: Treatment + Region + OAD Stratum + Exposure Time|||
1665908|NCT01451398|3065789|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Deviation|0.018|||2-Sided|95.0|-0.12|-0.05|||||||
1665909|NCT01451398|3065792|Superiority or Other||Mean Difference (Net)|-7.42|Standard Error of the Mean|5.4||0.1698|2-Sided|95.0|-18.03|3.18|||Mixed Models Analysis|"Model: FPG = Baseline FPG + Region + Pooled OAD Stratum + Visit + Treatment + (Treatment * Visit)~Variance/Covariance Matrix is Autoregression 1"|||
1665910|NCT01451398|3065793|Superiority or Other||Odds Ratio (OR)|4.361||||0.0021|2-Sided|95.0|1.7|11.17|||Regression, Logistic|Model: Treatment + Pooled OAD Stratum + Region + Baseline HbA1c|||
1665911|NCT01451398|3065794|Superiority or Other||Odds Ratio (OR)|2.726||||0.0005|2-Sided|95.0|1.55|4.8|||Regression, Logistic|Model: Treatment + Pooled OAD Stratum + Region + Baseline HbA1c|||
1665912|NCT01451398|3065795|Superiority or Other||Mean Difference (Final Values)|-0.4|||<|0.0001|2-Sided|95.0|-0.57|-0.23|||Mixed Models Analysis|Change in HbA1c = Baseline HbA1c + Region + Pooled OAD Strata + Visit + Treatment + (Treatment*Visit), using AR(1) variance/covariance structure.|||
1665913|NCT01451203|3065798|Superiority or Other|||||||0.002|||||||Fisher Exact||||
1665914|NCT01451203|3065799|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1665915|NCT01451203|3065800|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1665916|NCT01451203|3065801|Superiority or Other||Hodges-Lehman point estimate of shift|0.0||||0.003|2-Sided|95.0|0.0|0.0|||ANCOVA|The ANCOVA on the ranks with treatment as factors and Baseline rank as covariate was used.||The mTSS was analyzed using LINEAR for the imputation of missing data at Week 24.|
1665917|NCT01451203|3065802|Superiority or Other||Hodges-Lehmann point estimate of shift|0.0|||<|0.001|2-Sided|95.0|0.0|0.0||The ANCOVA on the ranks with treatment as factors and Baseline rank as covariate was used.|ANCOVA|||"The mTSS was analyzed using LINEAR for the imputation of missing data at Week 52.The primary Week 52 analysis assessed whether treatment up to Week 52 with the CZP group was superior to the placebo group in mTSS at Week 52. The 2-sided null and alternative hypotheses were:~H0: πC = πM Ha: πC ≠ πM where πC represented subjects in the CZP group at Week 52 and πM represented subjects in the placebo group at Week 52."|
1665918|NCT01450943|3065809|Superiority||Odds Ratio (OR)|0.812339||||0.7974|2-Sided|95.0|0.2543|2.5224|||Fisher Exact||||
1665919|NCT01450943|3065810|Superiority||Odds Ratio (OR)|2.712595||||0.0517|2-Sided|95.0|0.9141|8.4839|||Fisher Exact||||
1665920|NCT01450813|3065816|Non-Inferiority or Equivalence|Sample size needed for a one-way ANOVA test with an alpha of 0.05 and power of 0.8 to rule out the null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence was a total of 64 or 16 per Group.|||||<|0.05||||||Comparisons of the means were accomplished via student's t-test with Bonferroni correction for multiple comparisons.|ANOVA|||Null hypothesis that neuromuscular blocking drugs have no effect on CVI with 95% confidence.|
1667984|NCT01416636|3069729|Superiority|||||||0.605|||||||Wilcoxon (Mann-Whitney)||||
1665921|NCT01450761|3065832|Superiority or Other (legacy)||Hazard Ratio (HR)|0.851||||0.0161|2-Sided|95.0|0.747|0.971|||Log Rank||HR = ipilimumab over placebo||
1665922|NCT01450761|3065833|Superiority or Other (legacy)||Hazard Ratio (HR)|0.961||||0.5678|2-Sided|95.0|0.838|1.102|||Log Rank||HR = ipilimumab over placebo||
1665923|NCT01450761|3065834|Superiority or Other (legacy)||Hazard Ratio (HR)|0.936||||0.3775|2-Sided|95.0|0.807|1.085|||Log Rank||HR = ipilimumab over placebo||
1665924|NCT01450696|3065837|Superiority or Other||Odds Ratio (OR)|0.74|||||2-Sided|95.0|0.28|1.96|||||||
1665925|NCT01450696|3065837|Superiority or Other||Difference in response rates|-7.58||||0.5402|2-Sided|95.0|-31.75|16.6|||Chi-squared|||The 95% CI for difference in response rates was constructed using the normal approximation to the binomial distribution.|
1665926|NCT01450696|3065838|Superiority or Other||Hazard Ratio (HR)|1.17||||0.5764|2-Sided|95.0|0.67|2.05|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.|
1665927|NCT01450696|3065838|Superiority or Other||Hazard Ratio (HR)|1.13||||0.6759|2-Sided|95.0|0.63|2.02|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 mL/min and ≥60 mL/min). Hazard ratio was estimated by Cox regression.|
1665928|NCT01450696|3065840|Superiority or Other||Hazard Ratio (HR)|1.02||||0.9458|2-Sided|95.0|0.52|2.02|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.|
1665929|NCT01450696|3065840|Superiority or Other||Hazard Ratio (HR)|1.0||||0.9931|2-Sided|95.0|0.49|2.04|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 mL/min and ≥60 mL/min). Hazard ratio was estimated by Cox regression.|
1665930|NCT01450696|3065842|Superiority or Other||Hazard Ratio (HR)|1.32||||0.1285|2-Sided|95.0|0.92|1.88|||Log Rank|||Unstratified analysis. Hazard ratio was estimated by Cox regression.|
1665931|NCT01450696|3065842|Superiority or Other||Hazard Ratio (HR)|1.24||||0.2401|2-Sided|95.0|0.86|1.78|||Log Rank|||Stratified analysis included stratum of creatinine clearance (45 to 59 milliliters per minute [mL/min] and greater than or equal to [≥] 60 mL/min). Hazard ratio was estimated by Cox regression.|
1665932|NCT01450397|3065847|Superiority or Other||||||<|0.0013|||||||t-test, 2 sided||||
1665933|NCT01450137|3065889|Superiority||Mean Difference (Final Values)|25.0||||0.0005|2-Sided|95.0|11.0|39.0|||z-test||Difference between restricted mean survival time at 12 months||
1665934|NCT01450137|3065890|Superiority|||||||0.0005|||||||Wilcoxon (Mann-Whitney)||||
1665935|NCT01450137|3065891|Superiority||Risk Difference (RD)|0.65||||0.001|2-Sided|95.0|0.36|0.94|||Fisher Exact||||
1665936|NCT01450137|3065892|Superiority||Risk Difference (RD)|0.45||||0.0301|2-Sided|95.0|0.11|0.79|||Fisher Exact||||
1665937|NCT01450007|3065896|Superiority or Other|||||||0.25|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 1 week.|
1665938|NCT01450007|3065896|Superiority or Other|||||||0.13|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 48 hours.|
1665939|NCT01450007|3065896|Superiority or Other|||||||0.61|||||||Kruskal-Wallis|||Comparison between the 3 groups for pain scores at 24 hours.|
1665940|NCT01450007|3065897|Superiority or Other|||||||0.76|||||||ANOVA||||
1665941|NCT01450007|3065898|Superiority or Other|||||||0.001|||||||ANOVA||||
1665942|NCT01450007|3065899|Superiority or Other|||||||0.001|||||||ANOVA||||
1665943|NCT01449955|3065900|Superiority||||||>|0.05|||||||ANOVA||||
1665944|NCT01449955|3065901|Superiority||||||<|0.05|||||||ANOVA||||
1665945|NCT01449955|3065902|Superiority||||||>|0.05|||||||ANOVA||||
1665946|NCT01449955|3065903|Superiority||||||>|0.05|||||||ANOVA||||
1665947|NCT01449955|3065904|Superiority||||||>|0.5|||||||ANOVA||||
1665948|NCT01449955|3065905|Superiority or Other||||||>|0.05|||||||ANOVA|||ANOVA comparing the results of change over time (e.g., comparing baseline to 1 month posttreatment) as well as comparing differences between condition (e.g., placebo compared to rapamycin).|
1665949|NCT01449929|3065921|Non-Inferiority or Equivalence|Non-inferiority of DTG 50 mg and DRV+RTV at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - DRV+RTV) is greater than -12%. If non-inferiority is established, superiority can be tested at the nominal 5% level based on a pre-specified testing procedure.|Difference in percentage|7.1||||0.025|2-Sided|95.0|0.9|13.2||P-value is for test of superiority.|Cochran-Mantel-Haenszel|Stratified analysis|Analysis was adjusted for the Baseline (BL) stratification factors: Baseline plasma HIV-1 RNA (<=100,000 c/mL vs >100,000 c/mL) and Baseline background dual NRTI therapy (ABC/3TC vs TDF/FTC).||
1665950|NCT01449721|3065964|Superiority or Other|||||||0.064|||||||2-sample z-test|z-test for differences in proportions||Null hypothesis: In patients with moderate severity sepsis, there is no change in the incidence of organ dysfunction within 72 hours associated with the use of an empiric fluid resuscitation algorithm.|
1665951|NCT01449708|3065965|Superiority or Other||Odds Ratio (OR)|3.04||||0.009|2-Sided|95.0|1.28|7.29|||Chi-squared|||Grouping of surgical procedures into three categories, analysis using bonferroni correction, 1) ReY group( gastric bypass, conversion to gastric bypass and revision gastric bypass) 2) Gastric Band (GB), 3) sleeve gastrectomy (SG)|
1665952|NCT01449708|3065967|Superiority or Other||Relative Risk|1.27||||0.04|2-Sided|95.0|1.01|1.61|||Chi-squared||||
1665953|NCT01449006|3066057|Superiority or Other|||||||0.95|||||||ANOVA|||Change in Glx/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1665954|NCT01449006|3066057|Superiority or Other|||||||0.29|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1665955|NCT01449006|3066057|Superiority or Other|||||||0.56|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1665956|NCT01449006|3066057|Superiority or Other|||||||0.66|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1665957|NCT01449006|3066057|Superiority or Other|||||||0.95|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1666051|NCT01445678|3066325|Superiority or Other||Risk Difference (RD)|-3.1|||||2-Sided|95.0|-7.23|0.89|||||||
1665958|NCT01449006|3066058|Superiority or Other|||||||0.72|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1665959|NCT01449006|3066058|Superiority or Other|||||||0.8|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1665960|NCT01449006|3066058|Superiority or Other|||||||0.94|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1665961|NCT01449006|3066058|Superiority or Other|||||||0.49|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1665962|NCT01449006|3066059|Superiority or Other|||||||0.82|||||||ANOVA|||Change in CSF neopterin levels was analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1665963|NCT01449006|3066060|Superiority or Other||Mean Difference (Final Values)|0.55|||||2-Sided|90.0|-0.47|1.55|||||Positive value reflects improved neurocognitive functioning in maraviroc arm compared to control arm.|Clinical relevance of the effect size observed at 12-months was assessed by generating Cohen’s d statistic and 90%CI around the estimate.|
1665964|NCT01449006|3066060|Superiority or Other||Cohen's d|0.77|||||2-Sided|90.0|-0.19|1.71|||||Positive value reflects improved neurocognitive functioning in maraviroc arm compared to control arm.|Clinical relevance of the effect size observed at 6-months was assessed by generating Cohen’s d statistic and 90% confidence interval (CI) around the estimate.|
1665965|NCT01449006|3066060|Superiority or Other|||||||0.05||||||This pilot study was conducted to generate effect sizes for a potential larger investigation. The study design and small sample size had limited power to detect a statistically significant effect at p<0.05, so no p-value threshold was strictly set.|Mixed Models Analysis|41 data points included (control n=14; maraviroc: n=27); n=1 control did not attend 12-month visit.||The primary outcome was analysed using a mixed-effect regression model with arm and time as fixed linear effects, arm*time interaction as a non-linear fixed effect and participant as a random effect to account for participant attrition.|
1665966|NCT01448850|3066070|Superiority or Other||Rate ratio|0.92||||0.645|2-Sided|90.0|0.68|1.25||Data was analyzed using Poisson regression with Pearson correction, adjusting for treatment, background therapy and history of previous exacerbations.|Poisson regression||||
1665967|NCT01448824|3066076|Non-Inferiority or Equivalence|Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of ~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.|Ratio of Geometric LS means|2.37|||||2-Sided|90.0|1.77|3.18|||||||
1665968|NCT01448824|3066077|Superiority or Other||Median Difference (Final Values)|0.0||||1|2-Sided|90.0|-0.5|0.5|||Wilcoxon signed rank||||
1665969|NCT01448824|3066078|Non-Inferiority or Equivalence|Up to 12 participants were enrolled in order for 8 to complete the study. The estimated variability in area under the concentration-time curve (AUC) was 20% coefficient of variation following a single dose of 100 mg LY2484595. Assuming that 70% of the total variability is contributed by intra-participant variability, a sample size of 8 participants provides a precision of ~15% for the geometric means ratio in AUC and Cmax of LY2484595 + ketoconazole to LY2484595 alone in log scale.|Ratio of Geometric LS Means|1.94|||||2-Sided|90.0|1.39|2.72|||||||
1665970|NCT01448707|3066084|Non-Inferiority or Equivalence|Week 96: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|non-linear mixed model|-0.7||||0.0022|2-Sided|95.0|-7.89|6.58|||Mixed Models Analysis||||
1665971|NCT01448707|3066084|Non-Inferiority or Equivalence|Week 48: Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|Non-linear mixed model|-3.5||||0.0016|2-Sided|95.0|-8.77|1.72|||Mixed Models Analysis||||
1665972|NCT01448707|3066085|Non-Inferiority or Equivalence|Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5% and 80% power.|Non-Linear mixed|-10.1||||0.6933|2-Sided|95.0|-19.5|-0.73|||Mixed Models Analysis||||
1665973|NCT01448707|3066086|Non-Inferiority or Equivalence|Non-inferiority of DRV/rtv monotherapy versus triple therapy was assessed with a maximum allowable difference of 12 percent (%), with a one-sided significance level of 2.5%.|Non-Linear mixed|-7.9||||0.2331|2-Sided|95.0|-14.64|-1.19||P-Value for non-inferiority of DRV/rtv MONO vs DRV/rtv + 2NRTIs (delta = 12%).|Mixed Models Analysis|Predicted response rate:confidence limits are obtained by means of logistic regression model with treatment group and Hepatitis C status as covariates|||
1665974|NCT01448616|3066087|Superiority or Other|||||||0.032|||||||Poisson GLME|||per protocol only here|
1665975|NCT01448616|3066088|Superiority or Other|||||||0.032|||||||Poisson GLME|||Per protocol analysis|
1665976|NCT01448616|3066089|Superiority or Other|||||||0.42|||||||Linear Mixed Effects Model|||for Per protocol only|
1665977|NCT01448616|3066089|Superiority or Other|||||||0.003|||||||Linear Mixed Effects Model|||For per protocol analysis|
1665978|NCT01448616|3066089|Superiority or Other|||||||0.003|||||||Linear Mixed Effects Model|||For per protocol analysis|
1665979|NCT01448616|3066090|Superiority or Other||Risk Ratio (RR)|0.78||||0.11|2-Sided|95.0|0.57|1.07|||Poisson GLME|||This is the per-protocol analysis including only persons who completed >30 days of study drug with 90% or better compliance by returned product count|
1665980|NCT01448616|3066090|Superiority or Other||Risk Ratio (RR)|0.95||||0.69|2-Sided|95.0|0.74|1.22||For per protocol analysis|Poisson GLME|||This is the per-protocol analysis including only persons who completed >30 days of study drug with 90% or better compliance by returned product count|
1665981|NCT01448616|3066090|Superiority or Other||Risk Ratio (RR)|0.74||||0.006|2-Sided|95.0|0.6|0.91||For per protocol analysis|Poisson GLME|||For per protocol analysis|
1665982|NCT01448213|3066097|Superiority or Other|||||||0.0005|||||||Log Rank||||
1665983|NCT01448213|3066098|Superiority or Other|||||||0.17|||||||Log Rank||||
1665984|NCT01448044|3066105|Superiority or Other||difference in percentages|38.85|||<|0.0001|2-Sided|95.0|21.703|55.997||The pvalue was based on the CochranMantelHaenszel (CMH) test, stratified by IL28B host genotype, geography, and baseline cirrhosis status.|Cochran-Mantel-Haenszel||||
1665985|NCT01447927|3066107|Superiority or Other|||||||0.7981|||||||Wilcoxon Rank-Rum Test (1-sided)|||The null hypothesis was that the percent change in mean pS6K1 values (from pre to post) was the same or increased for the metformin arm as compared to placebo. Assuming equal standard deviations (i.e. 50%) across the metformin and placebo groups, 30 participants per arm yielded 84% power to detect at least a 35% decrease in the metformin arm as compared to placebo, using a 1-sided t-test with a significant level of 0.05.|
1665986|NCT01447719|3066121|Superiority or Other||Specificity|100.0|||||2-Sided|95.0|78.0|100.0||||||Proportion of subjects who had a negative scan based on majority of 5 blinded readers|
1665987|NCT01447719|3066122|Superiority or Other||Sensitivity|96.0|||||2-Sided|95.0|80.0|100.0||||||Proportion of subjects who had a positive scan based on majority of 5 blinded readers|
1665988|NCT01447719|3066123|Superiority or Other||Correlation coefficient|0.76|Standard Error of the Mean|0.133|<|0.0001|2-Sided|95.0|0.62|0.85||A one-sided test (rho > 0) was performed with a significance level of alpha=0.05 to assess a significant correlation.|Spearman's Rank Order Correlation test|Asymptotic standard error and 95 percent CI used Fisher z-transformation.||Spearman's Rank Order Correlation of the median semiquantitative read (three readers) and the quantitative IHC measurement of cortical amyloid plaque density averaged across six brain regions.|
1665989|NCT01447719|3066124|Superiority or Other||Sensitivity|100.0|||||2-Sided|95.0|80.0|100.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a negative scan based on majority of 5 blinded readers|
1665990|NCT01447719|3066125|Superiority or Other||Sensitivity|92.0|||||2-Sided|95.0|78.0|98.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a positive scan based on majority of 5 blinded readers|
1665991|NCT01447706|3066126|Superiority or Other||Hazard Ratio (HR)|1.8||||0.023|2-Sided|95.0|1.08|2.98|||Log Rank||||
1665992|NCT01447706|3066126|Superiority or Other||Hazard Ratio (HR)|0.37||||0.007|2-Sided|95.0|0.18|0.76|||Log Rank||||
1665993|NCT01447511|3066132|Superiority or Other||||||=|0|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under rifampin conditions is the same.|
1665994|NCT01447511|3066132|Superiority or Other||||||=|0|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under fluconazole conditions is the same.|
1665995|NCT01447511|3066132|Superiority or Other||||||=|0|||||||ANOVA|||The null hypothesis is that the mean R-warfarin clearance among the five CYP2C9 genotypes under control conditions is the same.|
1665996|NCT01447511|3066132|Superiority or Other||||||<|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under rifampin conditions is the same.|
1665997|NCT01447511|3066132|Superiority or Other||||||=|0|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under fluconazole conditions is the same.|
1665998|NCT01447511|3066132|Superiority or Other||||||<|0.0001|||||||ANOVA|||The null hypothesis is that the mean S-warfarin clearance among the five CYP2C9 genotypes under control conditions is the same.|
1665999|NCT01447433|3066147|Superiority or Other||Mean Difference (Net)|98.5|Standard Error of the Mean|89.0||0.275|2-Sided|95.0|-81.6|278.7|||t-test, 2 sided||||
1666000|NCT01447433|3066148|Superiority or Other||Median Difference (Net)|0.87|Standard Error of the Mean|1.63||0.598|2-Sided|95.0|-2.44|4.17|||t-test, 2 sided||||
1666001|NCT01447433|3066149|Superiority or Other||Median Difference (Net)|0.13|Standard Error of the Mean|0.11||0.26|2-Sided|95.0|-0.1|0.35|||t-test, 2 sided||||
1666002|NCT01447433|3066150|Superiority or Other||Median Difference (Net)|-0.02|Standard Error of the Mean|0.15||0.647|2-Sided|95.0|-0.11|0.05|||t-test, 2 sided|||LDL|
1666003|NCT01447433|3066150|Superiority or Other||Median Difference (Net)|-0.26|Standard Error of the Mean|0.16||0.112|2-Sided|95.0|-0.58|0.06|||t-test, 2 sided|||HDL|
1666004|NCT01447433|3066150|Superiority or Other||Median Difference (Net)|0.07|Standard Error of the Mean|0.15||0.636|2-Sided|95.0|-0.24|0.39|||t-test, 2 sided|||TG|
1666005|NCT01447433|3066150|Superiority or Other||Median Difference (Net)|-0.08|Standard Error of the Mean|0.14||0.565|2-Sided|95.0|-0.36|0.2|||t-test, 2 sided|||TC|
1666006|NCT01447433|3066151|Superiority or Other||Mean Difference (Net)|0.94|Standard Error of the Mean|3.18||0.768|2-Sided|95.0|-5.52|7.41|||t-test, 2 sided|||Diastolic Blood Pressure|
1666007|NCT01447433|3066151|Superiority or Other||Median Difference (Net)|-3.8|Standard Error of the Mean|4.5||0.404|2-Sided|95.0|-12.9|5.3|||t-test, 2 sided|||Systolic Blood Pressure|
1666008|NCT01447433|3066152|Superiority or Other||Median Difference (Net)|0.98|Standard Error of the Mean|0.85||0.255|2-Sided|95.0|-0.74|2.7|||t-test, 2 sided|||Hip Circumference|
1666009|NCT01447433|3066152|Superiority or Other||Mean Difference (Net)|-1.22|Standard Error of the Mean|2.07||0.56|2-Sided|95.0|-5.42|2.98|||t-test, 2 sided|||Abdominal Circumference|
1666010|NCT01447433|3066152|Superiority or Other||Median Difference (Net)|1.14|Standard Error of the Mean|1.7||0.508|2-Sided|95.0|-2.31|4.58|||t-test, 2 sided|||Waist Circumference|
1666011|NCT01447433|3066153|Superiority or Other||Median Difference (Net)|5.72|Standard Error of the Mean|2.25||0.016|2-Sided|95.0|1.15|10.29|||t-test, 2 sided||||
1666012|NCT01447433|3066154|Superiority or Other||Median Difference (Net)|1.1|Standard Error of the Mean|0.49||0.031|2-Sided|95.0|0.1|2.09|||t-test, 2 sided||||
1666013|NCT01447433|3066155|Superiority or Other||Median Difference (Net)|0.18|Standard Error of the Mean|0.07||0.018|2-Sided|95.0|0.03|0.32|||t-test, 2 sided|||Visceral Fat Mass|
1666014|NCT01447433|3066155|Superiority or Other||Median Difference (Net)|-0.5|Standard Error of the Mean|0.28||0.082|2-Sided|95.0|-1.06|0.07|||t-test, 2 sided|||Body Lean Mass|
1666015|NCT01447433|3066155|Superiority or Other||Mean Difference (Net)|0.88|Standard Error of the Mean|0.41||0.038|2-Sided|95.0|0.05|1.7|||t-test, 2 sided|||Body Fat Mass|
1666016|NCT01447433|3066156|Superiority or Other||Mean Difference (Net)|0.439|Standard Error of the Mean|0.56||0.441|2-Sided|95.0|-0.7|1.58|||t-test, 2 sided||||
1666149|NCT01444430|3066440|Superiority or Other||Mean Difference (Final Values)|4.4|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|3.3|5.4|||ANOVA||||
1666017|NCT01447420|3066158|Superiority or Other||Odds Ratio (OR)|4.03|||||2-Sided|95.0|1.19|13.61|||||Odds Ratio for SVR estimated from the logistic regression model.|IL28B - CC vs TT|
1666018|NCT01447420|3066158|Superiority or Other||Odds Ratio (OR)|5.45|||||2-Sided|95.0|2.27|13.12|||||Odds Ratio for SVR estimated from the logistic regression model.|IL28B - CC vs CT|
1666019|NCT01447420|3066158|Superiority or Other||Odds Ratio (OR)|0.86|||||2-Sided|95.0|0.28|2.59|||||Odds Ratio for SVR estimated from the logistic regression model.|Anemia in the first month of treatment vs No anemia|
1666020|NCT01447420|3066158|Superiority or Other||Odds Ratio (OR)|1.68|||||2-Sided|95.0|0.69|4.14|||||Odds Ratio for SVR estimated from the logistic regression model.|Anemia after the first month of treatment vs No anemia|
1666021|NCT01447420|3066161|Superiority or Other|||||||0.0007|||||||Chi-squared|Participants without measurement at the end of the 24 week untreated follow-up period were considered as non-responders.||IL28B Genotypes (CC, CT or TT)|
1666022|NCT01446809|3066197|Superiority|||||||0.13|||||||Wilcoxon (Mann-Whitney)||||
1666023|NCT01446809|3066198|Superiority|||||||0.4|||||||Wilcoxon (Mann-Whitney)||||
1666024|NCT01446666|3066208|Superiority|||||||0.004|||||||McNemar||||
1666025|NCT01446666|3066209|Superiority||||||<|0.01|||||||McNemar||||
1666026|NCT01446666|3066210|Superiority||||||<|0.01|||||||McNemar||||
1666027|NCT01446666|3066211|Superiority||||||<|0.01|||||||McNemar|||The HCC detection rate was defined as the number of patients with HCC detected by a given modality divided by the total number of patients with HCC detected by all modalities and by follow-up dynamic CT scan. The HCC detection rates from ultrasonography and MRI were compared.|
1666028|NCT01446419|3066214|Superiority or Other|||||||0.019|||||||ANCOVA|P-value from ANCOVA with factors of tx group, analysis center and tx group by analysis center interaction, and a covariate of baseline ODI score.|||
1666029|NCT01446159|3066252|Superiority||Hazard Ratio (HR)|0.995||||0.88|2-Sided|95.0|0.692|1.434|||Log Rank||||
1666030|NCT01446003|3066264|Superiority or Other||Mean Difference (Final Values)|-1.69|||||2-Sided|90.0|-4.55|1.17||||||Treatment comparison of maxMAΔ in DBP from baseline to Day 10 after PM dosing|
1666031|NCT01446003|3066264|Superiority or Other||Mean Difference (Final Values)|5.26|||||2-Sided|90.0|0.81|9.71||||||Treatment comparison of maxMAΔ in DBP from baseline to Day 10 after AM dosing|
1666032|NCT01446003|3066264|Superiority or Other||Mean Difference (Final Values)|-0.94|||||2-Sided|90.0|-5.68|3.81||||||Treatment comparison of maxMAΔ in SBP from baseline to Day 10 after PM dosing|
1666033|NCT01446003|3066264|Superiority or Other||Mean Difference (Final Values)|7.9|||||2-Sided|90.0|2.44|13.35||||||Treatment comparison of maxMAΔ in SBP from baseline to Day 10 after AM dosing|
1666034|NCT01446003|3066265|Superiority or Other||Median Difference (Final Values)|1.57|||||2-Sided|90.0|0.19|2.96|||||||
1666035|NCT01446003|3066266|Superiority or Other||Mean Difference (Final Values)|2.02|||||2-Sided|90.0|-0.52|4.56||||||If the upper limit of the 90% confidence interval lies below the bound 5 mmHg, the hypothesis that change from baseline in ambulatory 24-hour mean SBP in participants with mild to moderate hypertension following 10 days of multiple dosing of MK-8457 is similar to placebo will be supported.|
1666036|NCT01445951|3066267|Superiority or Other||Odds Ratio (OR)|0.449||||0.0158|2-Sided|95.0|0.23|0.86|||Regression, Logistic|Model: Treatment + Basal insulin stratum + Region + Baseline HbA1c|Gen2 in the numerator, Aspart in the denominator||
1666037|NCT01445951|3066268|Superiority or Other|||||||0.1022|||||||Negative Binomial Regression|Model: Region + Basal Insulin Stratum + Treatment + Exposure Time|||
1666038|NCT01445951|3066269|Superiority or Other||||||<|0.0001|||||||Negative Binomial Regression|Model: Region + Basal Insulin Stratum + Treatment + Exposure Time|||
1666039|NCT01445951|3066270|Superiority or Other||Odds Ratio (OR)|0.5328||||0.0156|2-Sided|95.0|0.3198|0.8877|||Regression, Logistic|Logistic model with affects for Region, Basal insulin stratum, and Treatment|||
1666040|NCT01445951|3066272|Superiority or Other|||||||0.0079|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero|
1666041|NCT01445951|3066272|Superiority or Other|||||||0.6807|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero|
1666042|NCT01445951|3066272|Superiority or Other|||||||0.4955|||||||t-test, 2 sided|||Within treatment analysis of change from Baseline comparing if change was different from zero|
1666043|NCT01445951|3066272|Superiority or Other||Mean Difference (Final Values)|-1.32|Standard Error of the Mean|0.512||0.0102|2-Sided|95.0|-2.33|-0.31|||ANCOVA|ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment|ANCOVA: Weight change from baseline = Baseline weight + Change from baseline in HbA1c + Region + Basal insulin stratum + Treatment||
1666044|NCT01445951|3066275|Superiority or Other||Mean Difference (Net)|-35.42|Standard Error of the Mean|10.622|||2-Sided|95.0|-56.25|-14.59|||||MMRM: FPG = Baseline FPG + Region + Basal insulin stratum + Visit + Treatment + (Visit*Treatment)||
1666045|NCT01445951|3066276|Superiority or Other||Mean Difference (Net)|0.01|Standard Error of the Mean|0.016|||2-Sided|95.0|-0.02|0.04|||||Mixed Model Repeated Measure (MMRM): FEV1 = Baseline FEV1 + Age + Gender + Race + Baseline Height + Visit + Treatment + (Visit*Treatment)||
1666046|NCT01445951|3066277|Non-Inferiority or Equivalence|Non-inferiority with 0.4 margin|Mean Difference (Net)|0.19|Standard Error of the Mean|0.086|||2-Sided|95.0|0.02|0.36||||||MMRM (mixed model repeated measures) model with auto-regression (1): HbA1c = Baseline HbA1c + region + basal insulin stratum + visit + treatment + (visit*treatment)|
1666047|NCT01445847|3066306|Superiority or Other||Percentage|5.0|||<|0.05|2-Sided|95.0|1.7|9.1|||Comparison of proportions|||We used incidence reported to AIMS study to calculate the sample size of this study. We set the null hypothesis as (percentage point of laryngospasm incidence in placebo group (µ1) – percentage point of laryngospasm incidence in Lidocaine group (µ2) = 0), with alternative hypothesis is (µ1 > µ2) by 5% was analyzed by comparison of two proportions. A sample size of 380 patients (190 per group) was adequate to detect a 5-percentage point difference in the incidence with 80% power and p = 0.05.|
1666048|NCT01445678|3066322|Superiority or Other||Risk Difference (RD)|0.7|||||2-Sided|95.0|-0.88|2.37|||||||
1666049|NCT01445678|3066323|Superiority or Other||Risk Difference (RD)|-4.1|||||2-Sided|95.0|-9.09|0.94|||||||
1666050|NCT01445678|3066324|Superiority or Other||Risk Difference (RD)|-0.4|||||2-Sided|95.0|-3.4|2.33|||||||
1666052|NCT01445678|3066326|Non-Inferiority or Equivalence|Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.|Risk Difference (RD)|-1.0|||||2-Sided|95.0|-4.52|2.59|||||||
1666053|NCT01445678|3066327|Non-Inferiority or Equivalence|Non-inferiority was concluded if the lower bound of the 2-sided 95% confidence interval was greater than -10%.|Risk Difference (RD)|-4.2|||||2-Sided|95.0|-8.91|0.54|||||||
1666054|NCT01445301|3066370|Superiority or Other|||||||0.065|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 12|
1666055|NCT01445301|3066370|Superiority or Other|||||||0.008|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 8|
1666056|NCT01445301|3066370|Superiority or Other|||||||0.009|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 4|
1666057|NCT01445301|3066370|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 2|
1666058|NCT01445301|3066370|Superiority or Other||||||<|0.48|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 once daily and CLDM twice daily at Week 1|
1666059|NCT01445301|3066370|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 12|
1666060|NCT01445301|3066370|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 8|
1666061|NCT01445301|3066370|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 4|
1666062|NCT01445301|3066370|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 2|
1666063|NCT01445301|3066370|Superiority or Other||||||<|0.002|||||||Cochran-Mantel-Haenszel|||Comparison of GSK2585823 twice daily and CLDM twice daily at Week 1|
1666064|NCT01445301|3066371|Superiority or Other|||||||0.006|||||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 12|
1666065|NCT01445301|3066371|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 8|
1666066|NCT01445301|3066371|Superiority or Other||||||<|0.187|||||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 4|
1666067|NCT01445301|3066371|Superiority or Other||||||<|0.335|||||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 2|
1666068|NCT01445301|3066371|Superiority or Other||||||<|0.572|||||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 1|
1666069|NCT01445301|3066371|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 12|
1666070|NCT01445301|3066371|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 8|
1666071|NCT01445301|3066371|Superiority or Other||||||<|0.022|||||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 4|
1666072|NCT01445301|3066371|Superiority or Other||||||<|0.844|||||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 2|
1666073|NCT01445301|3066371|Superiority or Other||||||<|0.47|||||||Cochran-Mantel-Haenszel|||Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 1|
1666074|NCT01445301|3066372|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1666075|NCT01445301|3066372|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1666076|NCT01445301|3066373|Superiority||Mean Difference (Net)|-12.37|||<|0.001|2-Sided|95.0|-17.05|-7.68|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 12|
1666077|NCT01445301|3066373|Superiority||Mean Difference (Net)|-13.04|||<|0.001|2-Sided|95.0|-17.83|-8.25|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 8|
1666078|NCT01445301|3066373|Superiority||Mean Difference (Net)|-14.17|||<|0.001|2-Sided|95.0|-18.97|-9.37|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 4|
1666079|NCT01445301|3066373|Superiority||Mean Difference (Net)|-11.05|||<|0.001|2-Sided|95.0|-16.3|-5.8|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 2|
1666080|NCT01445301|3066373|Superiority||Mean Difference (Net)|-9.11|||<|0.001|2-Sided|95.0|-13.53|-4.68|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 1|
1666081|NCT01445301|3066373|Superiority||Mean Difference (Net)|-8.56|||<|0.001|2-Sided|95.0|-12.71|-4.41|||ANCOVA|||Inflammatory Lesion Counts, WEEK 12|
1666082|NCT01445301|3066373|Superiority||Mean Difference (Net)|-8.08|||<|0.001|2-Sided|95.0|-12.63|-3.53|||ANCOVA|||Inflammatory Lesion Counts, WEEK 8|
1666083|NCT01445301|3066373|Superiority||Mean Difference (Net)|-7.83|||<|0.001|2-Sided|95.0|-12.03|-3.62|||ANCOVA|||Inflammatory Lesion Counts, WEEK 4|
1666084|NCT01445301|3066373|Superiority||Mean Difference (Net)|-9.57|||<|0.001|2-Sided|95.0|-13.83|-5.3|||ANCOVA|||Inflammatory Lesion Counts, WEEK 2|
1666085|NCT01445301|3066373|Superiority||Mean Difference (Net)|-8.32|||<|0.001|2-Sided|95.0|-12.76|-3.88|||ANCOVA|||Inflammatory Lesion Counts, WEEK 1|
1666086|NCT01445301|3066373|Superiority||Mean Difference (Net)|-11.18|||<|0.001|2-Sided|95.0|-15.11|-7.25|||ANCOVA|||Total Lesion Counts, WEEK 12|
1666087|NCT01445301|3066373|Superiority||Mean Difference (Net)|-11.33|||<|0.001|2-Sided|95.0|-15.37|-7.3|||ANCOVA|||Total Lesion Counts, WEEK 8|
1666088|NCT01445301|3066373|Superiority||Mean Difference (Net)|-12.12|||<|0.001|2-Sided|95.0|-15.9|-8.35|||ANCOVA|||Total Lesion Counts, WEEK 4|
1666089|NCT01445301|3066373|Superiority||Mean Difference (Net)|-11.17|||<|0.001|2-Sided|95.0|-15.18|-7.16|||ANCOVA|||Total Lesion Counts, WEEK 2|
1666090|NCT01445301|3066373|Superiority||Mean Difference (Net)|-8.9|||<|0.001|2-Sided|95.0|-12.32|-5.48|||ANCOVA|||Total Lesion Counts, WEEK 1|
1666150|NCT01444430|3066441|Superiority or Other||Hazard Ratio (HR)|0.835||||0.002|2-Sided|95.0|0.745|0.937|||Regression, Cox||||
1666360|NCT01438814|3067273|Superiority or Other||Odds Ratio (OR)|0.797||||0.2108||95.0|0.558|1.137|||Regression, Logistic||||
1666091|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.68|||<|0.001|2-Sided|95.0|-15.06|-4.3|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 12|
1666092|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.84|||<|0.002|2-Sided|95.0|-14.28|-3.39|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 8|
1666093|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.27|||<|0.001|2-Sided|95.0|-14.72|-3.83|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 4|
1666094|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.3|||<|0.005|2-Sided|95.0|-14.1|-2.5|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 2|
1666095|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-5.8|||<|0.011|2-Sided|95.0|-10.29|-1.32|||ANCOVA|||Non-Inflammatory Lesion Counts, WEEK 1|
1666096|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.2|||<|0.002|2-Sided|95.0|-13.34|-3.06|||ANCOVA|||Inflammatory Lesion Counts, WEEK 12|
1666097|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.73|||<|0.002|2-Sided|95.0|-14.2|-3.26|||ANCOVA|||Inflammatory Lesion Counts, WEEK 8|
1666098|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-7.64|||<|0.005|2-Sided|95.0|-12.93|-2.35|||ANCOVA|||Inflammatory Lesion Counts, WEEK 4|
1666099|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-7.21|||<|0.011|2-Sided|95.0|-12.73|-1.69|||ANCOVA|||Inflammatory Lesion Counts, WEEK 2|
1666100|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-10.54|||<|0.001|2-Sided|95.0|-15.12|-5.97|||ANCOVA|||Inflammatory Lesion Counts, WEEK 1|
1666101|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.43|||<|0.001|2-Sided|95.0|-14.11|-4.75|||ANCOVA|||Total Lesion Counts, WEEK 12|
1666102|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-9.12|||<|0.001|2-Sided|95.0|-13.82|-4.43|||ANCOVA|||Total Lesion Counts, WEEK 8|
1666103|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-8.89|||<|0.001|2-Sided|95.0|-13.37|-4.41|||ANCOVA|||Total Lesion Counts, WEEK 4|
1666104|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-8.51|||<|0.001|2-Sided|95.0|-13.24|-3.77|||ANCOVA|||Total Lesion Counts, WEEK 2|
1666105|NCT01445301|3066373|Non-Inferiority or Equivalence|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-7.71|||<|0.001|2-Sided|95.0|-11.3|-4.12|||ANCOVA|||Total Lesion Counts, WEEK 1|
1666106|NCT01445301|3066374|Superiority||Mean Difference (Net)|-8.2|||<|0.001|2-Sided|95.0|-11.6|-4.8|||ANCOVA|||WEEK 12|
1666107|NCT01445301|3066374|Superiority||Mean Difference (Net)|-8.6|||<|0.001|2-Sided|95.0|-12.1|-5.1|||ANCOVA|||WEEK 8|
1666108|NCT01445301|3066374|Superiority||Mean Difference (Net)|-9.7|||<|0.001|2-Sided|95.0|-13.1|-6.2|||ANCOVA|||WEEK 4|
1666109|NCT01445301|3066374|Superiority||Mean Difference (Net)|-8.1|||<|0.001|2-Sided|95.0|-11.4|-4.7|||ANCOVA|||WEEK 2|
1666110|NCT01445301|3066374|Superiority||Mean Difference (Net)|-6.0|||<|0.001|2-Sided|95.0|-8.8|-3.2|||ANCOVA|||WEEK 1|
1666111|NCT01445301|3066374|Superiority||Mean Difference (Net)|-2.8|||<|0.002|2-Sided|95.0|-4.6|-1.0|||ANCOVA|||WEEK 12|
1666112|NCT01445301|3066374|Superiority||Mean Difference (Net)|-2.7|||<|0.003|2-Sided|95.0|-4.5|-0.9|||ANCOVA|||WEEK 8|
1666113|NCT01445301|3066374|Superiority||Mean Difference (Net)|-2.5|||<|0.002|2-Sided|95.0|-4.1|-0.9|||ANCOVA|||WEEK 4|
1666114|NCT01445301|3066374|Superiority||Mean Difference (Net)|-3.2|||<|0.001|2-Sided|95.0|-4.7|-1.6|||ANCOVA|||WEEK 2|
1666115|NCT01445301|3066374|Superiority||Mean Difference (Net)|-2.5|||<|0.001|2-Sided|95.0|-3.9|-1.1|||ANCOVA|||WEEK 1|
1666116|NCT01445301|3066374|Non-Inferiority|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.6|||<|0.005|2-Sided|95.0|-9.5|-1.7|||ANCOVA|||WEEK 12|
1666117|NCT01445301|3066374|Non-Inferiority|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.5|||<|0.006|2-Sided|95.0|-9.4|-1.6|||ANCOVA|||WEEK 8|
1666118|NCT01445301|3066374|Non-Inferiority|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Odds Ratio (OR)|-5.8|||<|0.003|2-Sided|95.0|-9.6|-1.9|||ANCOVA|||WEEK 4|
1666119|NCT01445301|3066374|Non-Inferiority|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-5.4|||<|0.004|2-Sided|95.0|-9.1|-1.7|||ANCOVA|||WEEK 2|
1666120|NCT01445301|3066374|Non-Inferiority|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-3.4|||<|0.028|2-Sided|95.0|-6.5|-0.4|||ANCOVA|||WEEK 1|
1666121|NCT01445301|3066374|Non-Inferiority|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.6|||<|0.03|2-Sided|95.0|-5.0|-0.3|||ANCOVA|||WEEK 12|
1666122|NCT01445301|3066374|Non-Inferiority|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.7|||<|0.026|2-Sided|95.0|-5.1|-0.3|||ANCOVA|||WEEK 8|
1666123|NCT01445301|3066374|Non-Inferiority|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-2.0|||<|0.084|2-Sided|95.0|-4.2|0.3|||ANCOVA|||WEEK 4|
1666124|NCT01445301|3066374|Non-Inferiority|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-1.8|||<|0.113|2-Sided|95.0|-4.0|0.4|||ANCOVA|||WEEK 2|
1666125|NCT01445301|3066374|Non-Inferiority|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.|Mean Difference (Net)|-3.0|||<|0.001|2-Sided|95.0|-4.4|-1.5|||ANCOVA|||WEEK 1|
1666126|NCT01445301|3066376|Non-Inferiority|If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established|Mean Difference (Net)|-8.2|||<|0.001|2-Sided|95.0|-12.9|-3.6|||ANCOVA||||
1666127|NCT01445301|3066376|Superiority or Other||Mean Difference (Net)|-11.0|||<|0.001|2-Sided|95.0|-15.0|-7.0|||ANCOVA||||
1666128|NCT01444911|3066400|Superiority or Other (legacy)|||||||0.89|||||||ANOVA||||
1666129|NCT01444898|3066401|Superiority or Other|||||||0.004|||||||Mixed Models Analysis||||
1666130|NCT01444898|3066402|Superiority or Other|||||||0.04|||||||Mixed Models Analysis||||
1666131|NCT01444898|3066403|Superiority or Other|||||||0.2|||||||Mixed Models Analysis||||
1666132|NCT01444898|3066404|Superiority or Other|||||||0.2|||||||Mixed Models Analysis||||
1666133|NCT01444898|3066405|Superiority or Other|||||||0.8|||||||Mixed Models Analysis||||
1666134|NCT01444898|3066406|Superiority or Other|||||||0.04|||||||Mixed Models Analysis||||
1666135|NCT01444898|3066407|Superiority or Other|||||||0.8|||||||Mixed Models Analysis||||
1666136|NCT01444898|3066408|Superiority or Other|||||||0.08|||||||Mixed Models Analysis||||
1666137|NCT01444898|3066409|Superiority or Other|||||||0.07|||||||Mixed Models Analysis||||
1666138|NCT01444651|3066423|Superiority or Other||beta estimate|8.09|Standard Error of the Mean|4.05||0.05|2-Sided||||||Regression, Linear|||Linear regression was used to model the change in Matsuda disposition index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.|
1666139|NCT01444651|3066424|Superiority or Other||beta estimate|3.76|Standard Error of the Mean|1.38||0.009|2-Sided||||||Regression, Linear|||Linear regression was used to model the change in oral disposition index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.|
1666140|NCT01444651|3066425|Superiority or Other||beta estimate|1.48|Standard Error of the Mean|0.77||0.06|2-Sided||||||Regression, Linear|||Linear regression was used to model the change in insulinogenic index (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline value.|
1666141|NCT01444651|3066426|Superiority or Other||beta estimate|-0.18|Standard Error of the Mean|0.58||0.76|2-Sided||||||Regression, Linear|||Linear regression was used to model the difference in EndoPAT (3-month minus baseline), comparing tadalafil to placebo groups after adjusting for baseline values.|
1666142|NCT01444651|3066427|Superiority or Other||beta estimate|0.96|Standard Error of the Mean|0.68||0.18|2-Sided||||||Regression, Linear|||Linear regression was used to model the change in Matsuda Index (3-month minus baseline), comparing tadalafil versus placebo groups after adjusting for baseline value.|
1666143|NCT01444651|3066428|Superiority or Other||beta estimate|-1.25|Standard Error of the Mean|1.29||0.34|2-Sided||||||Regression, Linear|||Linear regression was used to model the change in HOMA-IR (3 month minus baseline value), comparing tadalafil versus placebo groups after adjusting for baseline HOMA-IR.|
1666144|NCT01444430|3066435|Superiority or Other||Hazard Ratio (HR)|0.739||||0.095|2-Sided|95.0|0.518|1.055|||Regression, Cox||||
1666145|NCT01444430|3066436|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.2||0.004|2-Sided|95.0|-1.0|-0.2|||ANOVA||||
1666146|NCT01444430|3066437|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.01|<|0.001|2-Sided|95.0|-0.1|-0.06|||ANCOVA||||
1666147|NCT01444430|3066438|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.0|<|0.001|2-Sided|95.0|-0.2|-0.1|||ANOVA||||
1666148|NCT01444430|3066439|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.6||0.272|2-Sided|95.0|-0.5|1.7|||ANOVA||||
1666151|NCT01444430|3066442|Non-Inferiority or Equivalence|The upper limit of the 95% CI of the hazard ratio will be used to assess statistical non-inferiority (non-inferiority margin=2).|Hazard Ratio (HR)|1.073|||||2-Sided|95.0|0.698|1.65|||||||
1666152|NCT01444417|3066445|Superiority or Other||Odds Ratio (OR)|0.813||||0.7103|2-Sided|95.0|0.277|2.391|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group|||
1666153|NCT01444417|3066446|Superiority or Other|||||||0.0004|||||||ANOVA|P-value from Analysis of Variance with main effects (treatment and age group) model after testing for non-significant interaction (p-value ≥ 0.10).|||
1666154|NCT01444417|3066447|Superiority or Other||Odds Ratio (OR)|9.0443||||0.0002|2-Sided|95.0|2.535|32.265|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.||The incidence of overall platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.|
1666155|NCT01444417|3066448|Superiority or Other||Odds Ratio (OR)|9.0497||||0.0018|2-Sided|95.0|1.896|43.199|||Cochran-Mantel-Haenszel|P-value from Cochran-Mantel-Haenszel test stratified by baseline age group.||The incidence of durable platelet response was compared by the Cochran-Mantel-Haenszel test stratified by the baseline age group. The Mantel-Haenszel common odds ratio (romiplostim vs placebo) was estimated along with its 95% confidence interval.|
1666156|NCT01444300|3066553|Superiority or Other|||||||0.8|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo|
1666157|NCT01444300|3066554|Superiority or Other|||||||0.7|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo after 12 weeks.|
1666158|NCT01444300|3066555|Superiority or Other|||||||0.51|||||||t-test, 2 sided|||t test comparing change in outcome between active and placebo|
1666159|NCT01444287|3066556|Superiority or Other||Mean Difference (Final Values)|-15.37|Standard Error of the Mean|4.984||0.003||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.|
1666160|NCT01444287|3066556|Superiority or Other||Mean Difference (Final Values)|-17.75|Standard Error of the Mean|4.984||0.0007||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.|
1666161|NCT01444287|3066556|Superiority or Other||Mean Difference (Final Values)|-0.0688|Standard Error of the Mean|5.044||0.9892||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.|
1666162|NCT01444287|3066557|Superiority or Other||Mean Difference (Final Values)|0.1705|Standard Error of the Mean|0.1098||0.1256||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.|
1666163|NCT01444287|3066557|Superiority or Other||Mean Difference (Final Values)|0.6864|Standard Error of the Mean|0.1098||0||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.|
1666164|NCT01444287|3066557|Superiority or Other||Mean Difference (Final Values)|0.0122|Standard Error of the Mean|0.1111||0.9127||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.|
1666165|NCT01444287|3066558|Superiority or Other||Mean Difference (Final Values)|-0.0008|Standard Error of the Mean|0.0032||0.8055||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.|
1666166|NCT01444287|3066558|Superiority or Other||Mean Difference (Final Values)|-0.0011|Standard Error of the Mean|0.0032||0.7301||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.|
1666167|NCT01444287|3066558|Superiority or Other||Mean Difference (Final Values)|-0.0057|Standard Error of the Mean|0.0031||0.0692||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.|
1666168|NCT01444287|3066559|Superiority or Other||Mean Difference (Final Values)|-0.0275|Standard Error of the Mean|0.2093||0.8957||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: lotrafilcon A (control) - narafilcon B (test) = 0. Ha: lotrafilcon A (control) - narafilcon B (test) ≠ 0.|
1666169|NCT01444287|3066559|Superiority or Other||Mean Difference (Final Values)|1.743|Standard Error of the Mean|0.2093||0||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control - Test.|Ho: Polymacon (+ control) - Narafilcon B (test) = 0. Ha: Polymacon (+ control) - Narafilcon B (test) ≠ 0.|
1666170|NCT01444287|3066559|Superiority or Other||Mean Difference (Final Values)|0.636|Standard Error of the Mean|0.2093||0.0035||95.0|||||Mixed Models Analysis||The mean difference is calculated as: Control-Test.|Ho: No Lenses (control) - narafilcon B (test) = 0. Ha: No Lenses (control) - narafilcon B (test) ≠ 0.|
1666171|NCT01444027|3066563|Superiority|||||||0.004||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.|||
1666172|NCT01444027|3066563|Superiority|||||||0.78||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.|||
1666173|NCT01444027|3066563|Superiority|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.|||
1666174|NCT01444027|3066564|Superiority|||||||0.17||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.|||
1666175|NCT01444027|3066564|Superiority|||||||0.16||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.|||
1666176|NCT01444027|3066564|Superiority|||||||0.003||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.|||
1666177|NCT01444027|3066565|Superiority|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.|||
1666178|NCT01444027|3066565|Superiority|||||||0.83|||||||Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.|||
1666179|NCT01444027|3066565|Superiority|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.|||
1666180|NCT01444027|3066566|Superiority|||||||0.01||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.|||
1666181|NCT01444027|3066566|Superiority|||||||0.48||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.|||
1666182|NCT01444027|3066566|Superiority|||||||0.001||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for the baseline value of the measure, hospice agency, and bereaved status.|||
1666183|NCT01444027|3066567|Superiority|||||||0.002||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status.|||
1666184|NCT01444027|3066567|Superiority|||||||0.9||||||Bonferroni adjusted p-value for 3 pairwise comparisons.|Regression, Linear||||
1666185|NCT01444027|3066567|Superiority|||||||0.002||||||Bonferroni adjusted p-value for 3 pairwise comparisons|Regression, Linear|Adjusted for baseline value of the measure, hospice agency, and bereaved status|||
1666186|NCT01443845|3066578|Superiority or Other||Mean Difference (Final Values)|0.0532|Standard Error of the Mean|0.0067|<|0.0001|2-Sided|95.0|0.04|0.0664||The MMRM analysis is based on all postbaseline observed data using a mixed model with terms for treatment, baseline, visit, LAMA use, treatment-by-visit and baseline-by-visit interactions.|Mixed Model for Repeated Measures (MMRM)||||
1666187|NCT01443845|3066579|Superiority or Other||Rate Ratio|0.9|Standard Error of the Mean|0.06||0.0884|2-Sided|95.0|0.8|1.02|||negative binomial regression||||
1666188|NCT01443845|3066580|Superiority or Other||Rate Ratio|0.95|Standard Error of the Mean|0.118||0.6354|2-Sided|95.0|0.75|1.19|||negative binomial regression||||
1666189|NCT01443845|3066581|Superiority or Other||Rate Ratio|1.05|Standard Error of the Mean|0.114||0.6475|2-Sided|95.0|0.84|1.32|||negative binomial regression|||Subgroup analysis between patients taking Advair verses patients taking Symbicort as LABA/ICS therapy.|
1666190|NCT01443845|3066581|Superiority or Other||Rate Ratio|0.85|Standard Error of the Mean|0.076||0.0385|2-Sided|95.0|0.74|0.99|||negative binomial regression|||Subgroup analysis between patients taking Advair verses patients taking Symbicort as LABA/ICS therapy.|
1666191|NCT01443845|3066581|Superiority or Other||Rate Ratio|1.11|Standard Error of the Mean|0.101||0.3164|2-Sided|95.0|0.91|1.35|||negative binomial regression|||Subgroup Analysis - By Sex - Female|
1666192|NCT01443845|3066581|Superiority or Other||Rate Ratio|0.83|Standard Error of the Mean|0.08||0.0195|2-Sided|95.0|0.71|0.97|||negative binomial regression|||Subgroup Analysis - By Sex - Male|
1666193|NCT01443845|3066581|Superiority or Other||Rate Ratio|0.92|Standard Error of the Mean|0.063||0.1634|2-Sided|95.0|0.81|1.04|||negative binomial regression||p-values are based on a negative binomial regression with factors Treatment and LAMA use.|Rate ratio (Roflumilast/Placebo). A rate ratio < 1 represents a favorable outcome for the test treatment.|
1666194|NCT01443403|3066596|Superiority or Other|||||||0.5029|||||||Welch’s t-test||||
1666195|NCT01443403|3066596|Superiority or Other|||||||0.5188|||||||Welch’s t-test||||
1666196|NCT01443403|3066596|Superiority or Other|||||||0.9826|||||||Welch’s t-test||||
1666197|NCT01443403|3066598|Superiority or Other|||||||0.6466|||||||Welch’s t-test||||
1666198|NCT01443403|3066598|Superiority or Other|||||||0.2799|||||||Welch’s t-test||||
1666199|NCT01443403|3066598|Superiority or Other|||||||0.2126|||||||Welch’s t-test||||
1666200|NCT01443403|3066600|Superiority or Other|||||||0.3689|||||||Wilcoxon (Mann-Whitney)||||
1666201|NCT01443403|3066600|Superiority or Other|||||||0.1355|||||||Wilcoxon (Mann-Whitney)||||
1666202|NCT01443403|3066600|Superiority or Other|||||||0.0272|||||||Wilcoxon (Mann-Whitney)||||
1666203|NCT01443403|3066603|Superiority or Other||LS Mean Difference|0.69|Standard Error of the Mean|0.542||0.2022|2-Sided|95.0|-0.37|1.76|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666204|NCT01443403|3066603|Superiority or Other||LS Mean Difference|2.07|Standard Error of the Mean|0.549||0.0002|2-Sided|95.0|0.99|3.15|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666205|NCT01443403|3066603|Superiority or Other||LS Mean Difference|2.36|Standard Error of the Mean|0.551|<|0.0001|2-Sided|95.0|1.28|3.45|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666206|NCT01443403|3066605|Superiority or Other||LS Mean Difference|0.55|Standard Error of the Mean|0.352||0.1211|2-Sided|95.0|-0.15|1.24|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666207|NCT01443403|3066605|Superiority or Other||LS Mean Difference|1.51|Standard Error of the Mean|0.359|<|0.0001|2-Sided|95.0|0.8|2.22|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666208|NCT01443403|3066605|Superiority or Other||LS Mean Difference|1.33|Standard Error of the Mean|0.358|<|0.0003|2-Sided|95.0|0.62|2.03|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666209|NCT01443403|3066608|Superiority or Other|||||||0.0079|||||||Wilcoxon (Mann-Whitney)||||
1666210|NCT01443403|3066608|Superiority or Other|||||||0.0011|||||||Wilcoxon (Mann-Whitney)||||
1666211|NCT01443403|3066608|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1666212|NCT01443403|3066609|Superiority or Other|||||||0.0118|||||||Wilcoxon (Mann-Whitney)||||
1666213|NCT01443403|3066609|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1666214|NCT01443403|3066609|Superiority or Other||||||<|0.0004|||||||Wilcoxon (Mann-Whitney)||||
1666215|NCT01443403|3066611|Superiority or Other||LS Mean Difference|0.42|Standard Error of the Mean|0.302||0.1648|2-Sided|95.0|-0.17|1.02|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666216|NCT01443403|3066611|Superiority or Other||LS Mean Difference|1.1|Standard Error of the Mean|0.305||0.0004|2-Sided|95.0|0.49|1.7|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666217|NCT01443403|3066611|Superiority or Other||LS Mean Difference|1.19|Standard Error of the Mean|0.307||0.0001|2-Sided|95.0|0.58|1.79|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666218|NCT01443403|3066613|Superiority or Other||LS Mean Difference|0.58|Standard Error of the Mean|0.317||0.0698|2-Sided|95.0|-0.05|1.2|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666219|NCT01443403|3066613|Superiority or Other||LS Mean Difference|1.22|Standard Error of the Mean|0.32||0.0002|2-Sided|95.0|0.59|1.85|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666220|NCT01443403|3066613|Superiority or Other||LS Mean Difference|1.54|Standard Error of the Mean|0.32|<|0.0001|2-Sided|95.0|0.9|2.17|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666221|NCT01443403|3066615|Superiority or Other||Difference|8.2||||0.2984|2-Sided|95.0|-7.2|23.6|||Chi-squared||||
1666222|NCT01443403|3066615|Superiority or Other||Difference|24.5||||0.0045|2-Sided|95.0|8.1|40.8|||Chi-squared||||
1666223|NCT01443403|3066615|Superiority or Other||Difference|24.3||||0.005|2-Sided|95.0|7.8|40.8|||Chi-squared||||
1666224|NCT01443403|3066617|Superiority or Other||Difference|13.1||||0.1461|2-Sided|95.0|-4.4|30.6|||Chi-squared||||
1666225|NCT01443403|3066617|Superiority or Other||Difference|31.8||||0.0005|2-Sided|95.0|15.0|48.7|||Chi-squared||||
1666226|NCT01443403|3066617|Superiority or Other||Difference|27.3||||0.003|2-Sided|95.0|10.0|44.6|||Chi-squared||||
1666227|NCT01443403|3066619|Superiority or Other||LS Mean Difference|0.5|Standard Error of the Mean|0.488||0.3077|2-Sided|95.0|-0.46|1.46|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666228|NCT01443403|3066619|Superiority or Other||LS Mean Difference|1.7|Standard Error of the Mean|0.492||0.0007|2-Sided|95.0|0.73|2.67|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666229|NCT01443403|3066619|Superiority or Other||LS Mean Difference|1.44|Standard Error of the Mean|0.495||0.0039|2-Sided|95.0|0.47|2.42|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666230|NCT01443403|3066621|Superiority or Other||LS Mean Difference|0.5|Standard Error of the Mean|0.476||0.2921|2-Sided|95.0|-0.43|1.44|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666231|NCT01443403|3066621|Superiority or Other||LS Mean Difference|1.64|Standard Error of the Mean|0.482||0.0008|2-Sided|95.0|0.69|2.58|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666232|NCT01443403|3066621|Superiority or Other||LS Mean Difference|1.33|Standard Error of the Mean|0.484||0.0065|2-Sided|95.0|0.38|2.28|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666233|NCT01443403|3066623|Superiority or Other||LS Mean Difference|0.63|Standard Error of the Mean|0.558||0.2572|2-Sided|95.0|-0.47|1.73|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666234|NCT01443403|3066623|Superiority or Other||LS Mean Difference|1.91|Standard Error of the Mean|0.569||0.0009|2-Sided|95.0|0.79|3.04|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666235|NCT01443403|3066623|Superiority or Other||LS Mean Difference|1.93|Standard Error of the Mean|0.568||0.0008|2-Sided|95.0|0.81|3.05|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666236|NCT01443403|3066625|Superiority or Other||LS Mean Difference|0.56|Standard Error of the Mean|0.599||0.3504|2-Sided|95.0|-0.62|1.74|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666237|NCT01443403|3066625|Superiority or Other||LS Mean Difference|1.95|Standard Error of the Mean|0.604||0.0014|2-Sided|95.0|0.76|3.14|||ANCOVA|ANCOVA model with treatment group as a term and baseline value as a covariate.|||
1666238|NCT01443403|3066625|Superiority or Other||LS Mean Difference|2.22|Standard Error of the Mean|0.605||0.0003|2-Sided|95.0|1.02|3.41|||ANCOVA|Analysis of covariance (ANCOVA) model with treatment group as a term and baseline value as a covariate.|||
1666239|NCT01443130|3066746|Superiority or Other|||||||0.1758||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666240|NCT01443130|3066746|Superiority or Other|||||||0.4501||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infection in the fetal circulation is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666241|NCT01443130|3066747|Superiority or Other|||||||0.1646||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Cox proportional hazards|||The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666242|NCT01443130|3066747|Superiority or Other|||||||0.0268||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Cox proportional hazards|||The null hypothesis is the incidence of clinical malaria (all species) is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666243|NCT01443130|3066748|Superiority or Other|||||||0.4184||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666288|NCT01441440|3066854|Superiority or Other||Mean Difference (Final Values)|0.21||||0.073|2-Sided|95.0|-0.02|0.45||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group||
1666244|NCT01443130|3066748|Superiority or Other|||||||0.063||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria infection (all species) measured by positive parasitemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666245|NCT01443130|3066749|Superiority or Other|||||||0.4947||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666246|NCT01443130|3066749|Superiority or Other|||||||0.369||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of active placental malaria infection is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666247|NCT01443130|3066750|Superiority or Other|||||||0.4354||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666248|NCT01443130|3066750|Superiority or Other|||||||0.2553||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of intrauterine growth restriction is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666249|NCT01443130|3066751|Superiority or Other|||||||0.7839||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666250|NCT01443130|3066751|Superiority or Other|||||||0.2566||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of low birth weight is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666251|NCT01443130|3066752|Superiority or Other|||||||0.8127||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666252|NCT01443130|3066752|Superiority or Other|||||||0.5959||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of infant mortality within 14 weeks of delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666253|NCT01443130|3066753|Superiority or Other|||||||0.2163||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666254|NCT01443130|3066753|Superiority or Other|||||||0.5187||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of preterm delivery is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666255|NCT01443130|3066754|Superiority or Other|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666256|NCT01443130|3066754|Superiority or Other|||||||0.6237||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of miscarriage is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666257|NCT01443130|3066755|Superiority or Other|||||||0.1166||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666258|NCT01443130|3066755|Superiority or Other|||||||0.4979||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of stillbirth is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666259|NCT01443130|3066756|Superiority or Other|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666260|NCT01443130|3066756|Superiority or Other|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal severe anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666261|NCT01443130|3066757|Superiority or Other|||||||0.6973||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666262|NCT01443130|3066757|Superiority or Other|||||||0.3089||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of maternal anemia is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666263|NCT01443130|3066758|Superiority or Other|||||||0.499||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666264|NCT01443130|3066758|Superiority or Other|||||||0.4941||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025.|Fisher Exact|||The null hypothesis is the incidence of malaria by placental impression smear is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666265|NCT01443130|3066759|Superiority or Other|||||||1||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025|Fisher Exact|||The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine IPT vs. maternal SP IPT.|
1666266|NCT01443130|3066759|Superiority or Other|||||||0.2441||||||A Bonferroni correction was used due to multiple comparisons. Comparisons are statistically significant if the two-sided p-value is ≤ 0.05/2=0.025|Fisher Exact|||The null hypothesis is the incidence of placental malaria infection based on histology is identical between subjects receiving maternal chloroquine prophylaxis vs. maternal SP IPT.|
1666267|NCT01442688|3066772|Non-Inferiority or Equivalence|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric mean ratio|0.991|||||2-Sided|90.0|0.94|1.04|||||||
1666268|NCT01442688|3066773|Non-Inferiority or Equivalence|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric mean ratio|1.02|||||2-Sided|90.0|0.995|1.04|||||||
1666269|NCT01442493|3066781|Superiority|||||||0.21|||||||Mixed Models Analysis||||
1666270|NCT01442493|3066782|Superiority|||||||0.11|||||||Mixed Models Analysis||||
1666271|NCT01442493|3066783|Superiority|||||||0.04|||||||Mixed Models Analysis||||
1666272|NCT01442493|3066784|Superiority|||||||0.54|||||||Mixed Models Analysis||||
1666273|NCT01442493|3066785|Superiority|||||||0.08|||||||Mixed Models Analysis||||
1666274|NCT01442493|3066786|Superiority|||||||0.06|||||||Mixed Models Analysis||||
1666275|NCT01442493|3066787|Superiority|||||||0.92|||||||Mixed Models Analysis||||
1666276|NCT01442376|3066789|Non-Inferiority or Equivalence|Non-inferiority margin of 15% at an alpha level of 2.5% in a 1-sided test (equivalent to 5.0% 2-sided test) to reject the null hypothesis that the study drug was inferior to the active control drug by more than the non-inferiority margin.|Risk Difference (RD)|-4.4|||||2-Sided|97.5|-16.4|7.6||||||The stratum adjusted Mantel-Haenszel method was used to compute the confidence interval (CI) of the difference in proportion. If the lower bound of the 97.5% CI of either the difference (CR0-24h palonosetron 20 mcg/kg - CR0-24h ondansetron) or the difference (CR0-24h palonosetron 10 mcg/kg - CR0-24h ondansetron) was strictly superior to the non-inferiority margin (δ=-0.15) then the null hypothesis (H0) was rejected. A power of 80% was used for sample size computation.|
1666277|NCT01442376|3066789|Non-Inferiority or Equivalence|Non-inferiority margin of 15% at an alpha level of 2.5% in a 1-sided test (equivalent to 5.0% 2-sided test) to reject the null hypothesis that the study drug was inferior to the active control drug by more than the non-inferiority margin.|Risk Difference (RD)|0.36|||||2-Sided|97.5|-11.7|12.4||||||The stratum adjusted Mantel-Haenszel method was used to compute the confidence interval (CI) of the difference in proportion. If the lower bound of the 97.5% CI of either the difference (CR0-24h palonosetron 20 mcg/kg - CR0-24h ondansetron) or the difference (CR0-24h palonosetron 10 mcg/kg - CR0-24h ondansetron) was strictly superior to the non-inferiority margin (δ=-0.15) then the null hypothesis (H0) was rejected. A power of 80% was used for sample size computation.|
1666278|NCT01442181|3066799|Superiority or Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue 3 month vs 6 month|
1666279|NCT01442181|3066799|Superiority or Other|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue in medical therapy group; baseline vs 3 month|
1666280|NCT01442181|3066799|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Comparison of the fatigue and energy was done in baseline-3 month, and 6 month in each group. Minimally Invasive: baseline vs 3 month|
1666281|NCT01442181|3066799|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Energy and fatigue 3 month vs 6 month in minimally invasive group|
1666282|NCT01442038|3066812|Superiority or Other||Hazard Ratio (HR)|0.968||||0.81|2-Sided|95.0|0.745|1.256||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model||||
1666283|NCT01442038|3066813|Superiority or Other||Hazard Ratio (HR)|1.073||||0.82|2-Sided|95.0|0.579|1.994||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model||||
1666284|NCT01442038|3066814|Superiority or Other||Hazard Ratio (HR)|0.665||||0.4|2-Sided|95.0|0.244|1.691||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying PCI: ACS versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model||||
1666285|NCT01442038|3066815|Superiority or Other||Hazard Ratio (HR)|0.948||||0.48|2-Sided|95.0|0.818|1.099||The p-value and hazard ratio are from Cox proportional hazards model stratifying by reason for qualifying percutaneous coronary intervention (PCI): acute coronary syndrome (ACS) versus non-ACS indication, and history of diabetes (yes versus no).|Cox Proportional Hazards Model||||
1666286|NCT01441882|3066831|Non-Inferiority|A non-parametric two-sided Mann-Whitney test was run assuming non-Gaussian distributions. Two-tailed with 95% confidence intervals.||||||0.05|||||||t-test, 2 sided||||
1666287|NCT01441440|3066854|Superiority or Other||Mean Difference (Final Values)|0.25||||0.034|2-Sided|95.0|0.02|0.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline score of CGI-S as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group||
1666358|NCT01438814|3067271|Superiority or Other||Odds Ratio (OR)|0.832||||0.2816||95.0|0.594|1.163|||Regression, Logistic||||
1666289|NCT01441440|3066855|Superiority or Other||Mean Difference (Final Values)|0.77||||0.137|2-Sided|95.0|-0.25|1.79||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group||
1666290|NCT01441440|3066855|Superiority or Other||Mean Difference (Final Values)|1.5||||0.004|2-Sided|95.0|0.48|2.53||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group||
1666291|NCT01441440|3066856|Superiority or Other||Mean Difference (Final Values)|1.06||||0.008|2-Sided|95.0|0.28|1.85||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group||
1666292|NCT01441440|3066856|Superiority or Other||Mean Difference (Final Values)|1.18||||0.004|2-Sided|95.0|0.39|1.97||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group||
1666293|NCT01441440|3066857|Superiority or Other||Mean Difference (Final Values)|0.25||||0.032|2-Sided|95.0|0.02|0.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group||
1666294|NCT01441440|3066857|Superiority or Other||Mean Difference (Final Values)|0.26||||0.025|2-Sided|95.0|0.03|0.49||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group||
1666295|NCT01441440|3066858|Superiority or Other||Mean Difference (Final Values)|2.64||||0.014|2-Sided|95.0|0.54|4.74||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group||
1666296|NCT01441440|3066858|Superiority or Other||Mean Difference (Final Values)|2.88||||0.008|2-Sided|95.0|0.77|5.0||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group||
1666297|NCT01441440|3066859|Superiority or Other||Mean Difference (Final Values)|1.12||||0.106|2-Sided|95.0|-0.24|2.48||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75-225 mg/day Flexible group||
1666298|NCT01441440|3066859|Superiority or Other||Mean Difference (Final Values)|1.5||||0.031|2-Sided|95.0|0.14|2.87||Two-sided p-value from an analysis of covariance model including treatment as a factor and baseline as a covariate.|ANCOVA||Adjusted mean difference = Placebo group - Venlafaxine 75 mg/day Fixed group||
1666299|NCT01441401|3066877|Superiority or Other||||||<|0.001|||||||Fisher Exact|||"The factor tested was treatment period with gabapentin. The null hypothesis was that there was no association between the treatment period with gabapentin and the number of participants who responded to the treatment with gabapentin."|
1666300|NCT01441401|3066878|Superiority or Other|||||||0.005|||||||Cochran-Armitage (EXACT)|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no ordinal trend in the number of responders to the treatment with gabapentin across the increasing number of concomitant antiepileptic drugs at baseline."|
1666301|NCT01441401|3066878|Superiority or Other|||||||0.034|||||||Fisher Exact|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no association between the number of concomitant antiepileptic drugs at baseline and the number of participants who responded to the treatment with gabapentin."|
1666302|NCT01441401|3066879|Superiority or Other|||||||0.018|||||||Fisher Exact|||"The factor tested was baseline frequency of epileptic seizure. The null hypothesis was that there was no difference between the baseline frequency of epileptic seizure and the number of participants who responded to the treatment with gabapentin."|
1666303|NCT01441401|3066880|Superiority or Other|||||||0.017|||||||Cochran-Armitage (EXACT)|||"The factor tested was baseline severity of epileptic seizure. The null hypothesis was that there was no ordinal trend in the number of responders to the treatment with gabapentin across the baseline severity of epileptic seizure (mild, moderate, and severe)."|
1666304|NCT01441401|3066880|Superiority or Other|||||||0.045|||||||Fisher Exact|||"The factor tested was baseline severity of epileptic seizure. The null hypothesis was that there was no association between the baseline severity of epileptic seizure (mild, moderate, and severe) and the number of participants who responded to the treatment with gabapentin."|
1666305|NCT01441245|3066885|Non-Inferiority or Equivalence|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|||||<|0.01|||||||Chi-squared|||Qualitative variables are expressed as percentage of partecipants and compared with chi-square test. p-value equal or lower than 0.05 are considered statistically significant.|
1666306|NCT01441245|3066886|Non-Inferiority or Equivalence|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.05|||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant|
1666307|NCT01441245|3066887|Non-Inferiority or Equivalence|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.01|||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.|
1667985|NCT01416636|3069730|Superiority|||||||0.0003|||||||Wilcoxon (Mann-Whitney)||||
1666308|NCT01441245|3066888|Non-Inferiority or Equivalence|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.03|||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.|
1666309|NCT01441245|3066889|Non-Inferiority or Equivalence|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|Risk Ratio (RR)|2.06||||0.01|2-Sided|95.0|1.65|2.57|||Regression, Linear||BNP levels at discharge >500 pg/ml (RR: 2.06 [1.65–2.57];).||
1666310|NCT01441245|3066889|Non-Inferiority or Equivalence|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.04|||||||t-test, 2 sided||||
1666311|NCT01441245|3066890|Non-Inferiority or Equivalence|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.02|||||||t-test, 2 sided||||
1666312|NCT01441245|3066891|Non-Inferiority or Equivalence|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.01|||||||t-test, 2 sided||||
1666313|NCT01441245|3066892|Non-Inferiority or Equivalence|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.|||||<|0.01|||||||Chi-squared|||Qualitative variables are expressed as percentage and compared with chi-square test. p values <0.05 were considered significant.|
1666314|NCT01441245|3066893|Non-Inferiority or Equivalence|The sample size used was preliminarily calculated from each co-primary endpoint. We included the following assumptions: (1) a 30 % or more effect size in the difference between mean paired changes in continuous co-primary endpoints (eGFR, creatinine, BNP and diuresis); standard variation of each group data not exceeding 20 %; (2) alpha = 0.05 two-tailed and (3) power (1-beta) = 80 %.||||||0.04|||||||t-test, 2 sided|||Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.|
1666315|NCT01440764|3066970|Superiority|||||||2e-07||||||a priori threshold for significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided||||
1666316|NCT01440764|3066970|Superiority||||||=|0||||||a priori threshold for statistical significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided||||
1666317|NCT01440764|3066970|Superiority||||||=|0.0006||||||a priori threshold for statistical significance was 0.05. Not adjusted for multiple comparisons.|t-test, 2 sided||||
1666318|NCT01440764|3066972|Superiority|||||||0.32||||||a priori threshold for significance was 0.05. Not corrected for multiple comparisons. Thes p-value describes the a priori analysis of comparing the response to furosemide to the mean response to saline.|t-test, 2 sided||||
1666319|NCT01440764|3066972|Superiority|||||||0.99||||||a priori threshold for significance was 0.05. Not corrected for multiple comparisons. This p-value describes the a priori analysis of comparing the furosemide test result to the saline test result.|t-test, 2 sided||||
1666320|NCT01440374|3067016|Superiority or Other||Odds Ratio (OR)|0.202||||0.0315|2-Sided|95.0|0.047|0.868|||Generalized Linear Mixed Models||||
1666321|NCT01440101|3067042|Superiority or Other|||||||0.942||||||P-value for comparison between the treated and placebo groups was based on analysis of covariance, adjusted for the baseline VAS score.|ANCOVA|||Change from Baseline at Week 24|
1666322|NCT01440101|3067042|Superiority or Other|||||||0.729||||||P-value for comparison between the treated and placebo groups was based on analysis of covariance, adjusted for the baseline VAS score.|ANCOVA|||Change from Baseline to Week 12|
1666323|NCT01440101|3067043|Superiority or Other||Difference in proportions|0.404|||<|0.001|2-Sided|95.0|0.223|0.586|||Fisher Exact|||Relapse-free proportions compared using a two-sided Fisher exact test. In the analysis, participants with unknown status are considered to have relapsed.|
1666324|NCT01440101|3067044|Superiority or Other|||||||0.006|||||||Wilcoxon rank sum test||||
1666325|NCT01440101|3067045|Superiority or Other||||||<|0.001||||||P-value obtained from the Van Elteren test stratified by the presence or absence of Gd+ lesions at baseline.|Van Elteren test||||
1666326|NCT01440101|3067048|Superiority or Other||||||<|0.001||||||P-value obtained from the Mann-Whitney U test stratified by the presence or absence of Gd+ lesions at baseline.|Wilcoxon (Mann-Whitney)||||
1666327|NCT01439945|3067108|Superiority or Other|||||||0.09|||||||Kruskal-Wallis||||
1666328|NCT01439945|3067108|Superiority or Other|||||||0.47|||||||Kruskal-Wallis||||
1666329|NCT01439945|3067109|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1666330|NCT01439945|3067112|Superiority or Other|||||||0.55||||||Weekly number of hot flashes were treated as a repeated measure for each patient.|ANOVA||||
1666331|NCT01439945|3067112|Superiority or Other|||||||0.25|||||||ANOVA|Weekly number of hot flashes were treated as a repeated measure for each patient.|||
1666332|NCT01439945|3067113|Superiority or Other|||||||0.67|||||||ANOVA|Weekly hot flash score was treated as a repeated measure for each patient.|||
1666359|NCT01438814|3067272|Superiority or Other||Odds Ratio (OR)|0.999||||0.9972||95.0|0.712|1.402|||Regression, Logistic||||
1666333|NCT01439945|3067113|Superiority or Other|||||||0.13|||||||ANOVA|Weekly hot flash score was treated as a repeated measure for each patient.|||
1666334|NCT01439724|3067135|Superiority or Other||Risk Ratio (RR)|0.158||||0.05|2-Sided|95.0|0.05|0.498|||Chi-squared|||The primary end point of the study was the incidence of grade 3–4 oral mucositis (OM) according to the WHO scale. Assuming an α =0.05 and a β = 0.20, with the estimates of proportion being 0.40 for placebo (P0) and 0.15 for LLLT (P1) a total of 94 patients were evaluated. One-sided test error was the basis for the sample size determination and all the reported P-values were derived from two-sided statistical tests. P-values less than or equal to 0.05 were considered statistically significant.|
1666335|NCT01439711|3067146|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1666336|NCT01439711|3067147|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1666337|NCT01439568|3067156|Superiority||Hazard Ratio (HR)|1.0608||||0.8072|2-Sided|95.0|0.6598|1.7055|||Logrank Test||||
1666338|NCT01439373|3067181|Other||Mean posterior difference|0.41|Standard Deviation|0.122|||||||||||Posterior Distribution of Difference= p805 - pPLC, where, p805 is the RVR rate for GSK2336805 and pPLC is the RVR rate for Placebo. 95% credible set was defined as the 2.5 and 97.5 percentiles. 95% credible interval for the estimate was 0.17 to 0.6||
1666339|NCT01439373|3067182|Other||Mean posterior difference|0.46|Standard Deviation|0.119|||||||||||Posterior Distribution of Difference= p805 - pPLC, where, p805 is the RVR rate for GSK2336805 and pPLC is the RVR rate for Placebo. 95% credible set was defined as the 2.5 and 97.5 percentiles. 95% credible interval for the estimate was 0.22 to 0.68.||
1666340|NCT01439360|3067205|Superiority or Other||Vaccine efficacy (VE)|49.8|||||2-Sided|97.5|41.8|56.8|||||VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.|The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for VE is above 15%.|
1666341|NCT01439360|3067206|Superiority or Other||Vaccine efficacy (VE)|63.2|||||2-Sided|97.5|51.8|72.3|||||VE was defined as the hazard ratio of cases of influenza A and or B disease in subjects receiving D-QIV vaccine in contrast with subjects receiving non-influenza vaccine control subtracted from 1.|The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for vaccine efficacy (VE) is above (>) 25%.|
1666342|NCT01439282|3067209|Superiority or Other (legacy)|||||||0.108||||||1-side P value was obtained|1-sample binomial test||||
1666343|NCT01439165|3067225|Non-Inferiority|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is > -10% .|Difference (%) Adacel-Expected Booster|-19.07|||||2-Sided|95.0|-22.3|-16.0||||||Comparison of the anti-Fimbriae (types 2 and 3) booster response rates between Adacel and historical groups|
1666344|NCT01439165|3067225|Non-Inferiority|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is > -10% .|Difference (%) Adacel-Expected Booster|-18.61|||||2-Sided|95.0|-21.7|-15.6||||||Comparison of the anti-Pertactin booster response rates between Adacel and historical groups|
1666345|NCT01439165|3067225|Non-Inferiority|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is > -10%|Difference (%) Adacel-Expected Booster|-4.21|||||2-Sided|95.0|-7.23|-1.34||||||Comparison of the anti-FHA booster response rates between the Adacel and historical groups|
1666346|NCT01439165|3067225|Non-Inferiority|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is > -10% .|Difference (%) Adacel-Expected Booster|16.12|||||2-Sided|95.0|13.27|18.73||||||comparison of anti-pertussis toxoid booster response rates was performed between the Adacel and historical groups|
1666347|NCT01439165|3067226|Non-Inferiority|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is > 0.66|GMC Ratio (Adacel/Historical Control)|2.18|||||2-Sided|95.0|1.84|2.6||||||Comparison of the post-vaccination anti-Fimbriae (types 2 and 3) GMCs between Adacel and historical Control groups|
1666348|NCT01439165|3067226|Non-Inferiority|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is > 0.66|GMC Ratio (Adacel/Historical Control)|2.94|||||2-Sided|95.0|2.46|3.51||||||Comparison of the anti-Pertactin GMCs between Adacel and historical Control groups|
1666349|NCT01439165|3067226|Non-Inferiority|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is > 0.66|GMC Ratio (Adacel/Historical Control)|5.22|||||2-Sided|95.0|4.51|6.05||||||Comparison of the anti-FHA GMCs between Adacel and historical Control groups|
1666350|NCT01439165|3067226|Non-Inferiority|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the ratio of GMCs between groups is > 0.66|GMC ratio (Adacel/Historical Control)|1.04|||||2-Sided|95.0|0.92|1.18||||||Comparison of anti-pertussis toxoid GMCs between Adacel and historical control groups|
1666351|NCT01439165|3067227|Non-Inferiority|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is > -10%|Difference (%) in Adacel-Td Adsorbed|-0.95|||||2-Sided|95.0|-5.4|4.0||||||Comparison of the anti-diphteria booster response rates between the two groups|
1666352|NCT01439165|3067227|Non-Inferiority|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of booster response rates between groups is > -10%|Difference (%) in Adacel-Td Adsorbed|-7.12|||||2-Sided|95.0|-12.0|-1.7||||||Comparison of the anti-tetanus booster response rates between the two groups|
1666353|NCT01439165|3067228|Non-Inferiority|Non-inferiority concluded if the lower limit of the 2-sided 95% CI of the difference of seroprotection rates between groups is > -10%|Difference (%) in Adacel-Td Adsorbed|0.42|||||2-Sided|95.0|-0.3|2.1||||||Comparison of anti-diphtheria seroprotection rates between the two groups|
1666354|NCT01439165|3067228|Non-Inferiority|Non-inferiority concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference of seroprotection rates between groups is > -10%|Difference (%) in Adacel-Td Adsorbed|0.0|||||2-Sided|95.0|-0.4|1.2||||||Comparison of anti-tetanus seroprotection rate between the two groups|
1666355|NCT01438840|3067267|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1666356|NCT01438814|3067269|Superiority or Other||Odds Ratio (OR)|0.951||||0.7682||95.0|0.681|1.328|||Regression, Logistic||||
1666357|NCT01438814|3067270|Superiority or Other||Mean Difference (Final Values)|0.62|Standard Error of the Mean|0.19||0.0011||95.0|0.25|0.98|||ANCOVA||||
1667986|NCT01416636|3069730|Superiority|||||||0.002|||||||ANCOVA||||
1666361|NCT01438814|3067274|Superiority or Other||Odds Ratio (OR)|0.997||||0.9886||95.0|0.689|1.445|||Regression, Logistic||||
1666362|NCT01438814|3067275|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.3||0.0545||95.0|0.0|1.0|||ANCOVA||||
1666363|NCT01438814|3067276|Superiority or Other|||||||0.0308|||||||Fisher Exact|Fishers exact p−value presented due to small cell counts|||
1666364|NCT01438814|3067277|Superiority or Other||Mean Difference (Final Values)|2.0|Standard Error of the Mean|2.1||0.3352||95.0|-2.1|6.1|||ANCOVA||||
1666365|NCT01438814|3067278|Superiority or Other||Odds Ratio (OR)|1.022||||0.9397|2-Sided|95.0|0.582|1.796|||Regression, Logistic|Model includes treatment and baseline HbA1c.|||
1666366|NCT01438814|3067279|Superiority or Other||Odds Ratio (OR)|0.96||||0.8201||95.0|0.672|1.37|||Regression, Logistic|Model includes treatment and continuous baseline HbA1c|||
1666367|NCT01438814|3067280|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.06||0.8924||95.0|-0.13|0.12|||ANCOVA||||
1666368|NCT01438814|3067280|Non-Inferiority or Equivalence|One-sided test relative to 0.35|Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.13|0.12|||ANCOVA||||
1666369|NCT01438710|3067281|Superiority or Other|||||||0.0048|||||||t-test, 2 sided|||The mean change (i.e., absolute change) from baseline (Day 7, pre-conversion) on FTM overall score to Day 14 (post-conversion) was evaluated using paired t-test (at 0.05 significance level, two sided). An estimation of mean change from baseline and the corresponding 95% confidence interval (CI) were provided.|
1666370|NCT01438489|3067297|Superiority or Other||Odds Ratio (OR)|2.65||||0.029|2-Sided|90.0|1.27|5.53|||Regression, Logistic|||High|
1666371|NCT01438489|3067297|Superiority or Other||Odds Ratio (OR)|3.55||||0.004|2-Sided|90.0|1.72|7.32|||Regression, Logistic|||High|
1666372|NCT01438489|3067298|Superiority or Other||Odds Ratio (OR)|1.94||||0.063|2-Sided|90.0|1.08|3.49|||Regression, Logistic|||All-comers|
1666373|NCT01438489|3067298|Superiority or Other||Odds Ratio (OR)|2.38||||0.014|2-Sided|90.0|1.33|4.26|||Regression, Logistic|||All-comers|
1666374|NCT01438229|3067364|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1666375|NCT01438060|3067402|Superiority or Other||Mean Difference (Final Values)|-1.35||||0.001|2-Sided|95.0|-2.16|-0.54|||ANOVA|||Analysis at Week 10|
1666376|NCT01438060|3067402|Superiority or Other||Mean Difference (Final Values)|0.23||||0.733|2-Sided|95.0|-1.08|1.54|||ANCOVA|||Analysis at baseline|
1666377|NCT01438060|3067404|Superiority or Other|||||||0.564||||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 10|
1666378|NCT01438060|3067404|Superiority or Other|||||||0.795||||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 8|
1666379|NCT01438060|3067404|Superiority or Other|||||||0.817||||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 6|
1666380|NCT01438060|3067404|Superiority or Other|||||||0.895||||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 4|
1666381|NCT01438060|3067404|Superiority or Other|||||||0.571||||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 3|
1666382|NCT01438060|3067404|Superiority or Other|||||||0.282||||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 2|
1666383|NCT01438060|3067404|Superiority or Other|||||||0.133||||||CMH Row Means test with controlling for study center|Cochran-Mantel-Haenszel|||Analysis at Week 1|
1666384|NCT01438060|3067408|Superiority or Other||Response ratio|1.07||||0.602|2-Sided|95.0|0.82|1.4||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 10|
1666385|NCT01438060|3067408|Superiority or Other||Response ratio|0.92||||0.525|2-Sided|95.0|0.71|1.19||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 8|
1666386|NCT01438060|3067408|Superiority or Other||Response ratio|0.99||||0.958|2-Sided|95.0|0.74|1.33||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 6|
1666387|NCT01438060|3067408|Superiority or Other||Response ratio|0.83||||0.255|2-Sided|95.0|0.6|1.14||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 4|
1666388|NCT01438060|3067408|Superiority or Other||Response ratio|0.93||||0.673|2-Sided|95.0|0.65|1.31||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 3|
1666389|NCT01438060|3067408|Superiority or Other||Response ratio|0.9||||0.6|2-Sided|95.0|0.62|1.32||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 2|
1666390|NCT01438060|3067408|Superiority or Other||Response ratio|0.88||||0.753|2-Sided|95.0|0.41|1.92||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at week 1|
1666391|NCT01438060|3067409|Superiority or Other||Response ratio|1.15||||0.175|2-Sided|95.0|0.94|1.41||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 10|
1666392|NCT01438060|3067409|Superiority or Other||Response ratio|1.1||||0.374|2-Sided|95.0|0.89|1.37||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 8|
1666393|NCT01438060|3067409|Superiority or Other||Response ratio|1.07||||0.59|2-Sided|95.0|0.84|1.36||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 6|
1666394|NCT01438060|3067409|Superiority or Other||Response ratio|0.92||||0.505|2-Sided|95.0|0.71|1.19||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 4|
1666395|NCT01438060|3067409|Superiority or Other||Response ratio|1.01||||0.967|2-Sided|95.0|0.76|1.32||CMH test with controlling for treatment and study center|Cochran-Mantel-Haenszel|||Analysis at Week 3|
1666396|NCT01438060|3067409|Superiority or Other||Response ratio|0.95||||0.766|2-Sided|95.0|0.69|1.31|||Cochran-Mantel-Haenszel|CMH test with controlling for treatment and study center||Analysis at Week 2|
1666397|NCT01438060|3067409|Superiority or Other||Response ratio|0.79||||0.391|2-Sided|95.0|0.47|1.35|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test with controlling for treatment and study center||Analysis at Week 1|
1666398|NCT01438060|3067412|Superiority or Other||Mean Difference (Final Values)|-1.02||||0.169|2-Sided|95.0|-2.49|0.44||ANCOVA model for LOCF data set included the baseline measure as covariate and the study center and treatment as main effects.|ANCOVA||Model based estimate|Analysis at Week 10|
1666399|NCT01438060|3067412|Superiority or Other||Mean Difference (Final Values)|0.17||||0.802|2-Sided|95.0|-1.15|1.49||Baseline data was evaluated by analysis of variance (ANOVA) with treatment and study center as main effects.|ANOVA||Model based estimate.|Analysis at Baseline (Day 0)|
1666400|NCT01437995|3067413|Superiority or Other|||||||0.031|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio|
1666401|NCT01437995|3067413|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio|
1666402|NCT01437995|3067413|Superiority or Other||||||<|0.14|||||||Kruskal-Wallis|||Comparison of change in FEV1/FVC ratio|
1666403|NCT01437995|3067414|Superiority or Other|||||||0.21|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC|
1666404|NCT01437995|3067414|Superiority or Other|||||||0.032|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC|
1666405|NCT01437995|3067414|Superiority or Other|||||||0.4|||||||Kruskal-Wallis|||Comparison of change in pre-bronchodilator FVC|
1666406|NCT01437995|3067414|Superiority or Other|||||||0.027|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1|
1666407|NCT01437995|3067414|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1|
1666408|NCT01437995|3067414|Superiority or Other||||||<|0.15|||||||Kruskal-Wallis|||Comparing change in pre-bronchodilator FEV1|
1666409|NCT01437995|3067415|Superiority or Other||Risk Ratio (RR)|1.24|||||2-Sided|95.0|0.83|1.81|||||||
1666410|NCT01437995|3067415|Superiority or Other||Risk Ratio (RR)|1.18|||||2-Sided|95.0|0.8|1.73|||||||
1666411|NCT01437995|3067415|Superiority or Other||Risk Ratio (RR)|0.93|||||2-Sided|95.0|0.63|1.41|||||||
1666412|NCT01437995|3067416|Superiority or Other|||||||0.002|||||||Kruskal-Wallis||||
1666413|NCT01437995|3067416|Superiority or Other|||||||0.022|||||||Kruskal-Wallis||||
1666414|NCT01437995|3067416|Superiority or Other|||||||0.43|||||||Kruskal-Wallis||||
1666415|NCT01437995|3067417|Superiority or Other||Hazard Ratio (HR)|1.07|||||2-Sided|95.3|0.69|1.65|||||||
1666416|NCT01437397|3067463|Superiority or Other||Least squares mean difference|-3.728|Standard Error of the Mean|1.066||0.0005|2-Sided|95.0|-5.819|-1.637|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates|||
1666417|NCT01437397|3067463|Superiority or Other||Least squares mean difference|-4.353|Standard Error of the Mean|1.075|<|0.0001|2-Sided|95.0|-6.462|-2.244|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates|||
1666418|NCT01437397|3067464|Superiority or Other||Least squares mean difference|1.395|Standard Error of the Mean|0.294|<|0.0001|2-Sided|95.0|0.818|1.972|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates|||
1666419|NCT01437397|3067464|Superiority or Other||Least squares mean difference|1.436|Standard Error of the Mean|0.297|<|0.0001|2-Sided|95.0|0.854|2.018|||Mixed Models Analysis|Treatment group, sex, smoking-status, visit, and treatment group-by-visit as factors; visit, age baseline BDI/SGRQ as covariates|||
1666420|NCT01437397|3067465|Superiority or Other||Least squares mean difference|0.026|Standard Error of the Mean|0.017||0.133|2-Sided|95.0|-0.008|0.06|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates|||
1666421|NCT01437397|3067465|Superiority or Other||Least squares mean difference|0.045|Standard Error of the Mean|0.017||0.01|2-Sided|95.0|0.011|0.079|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates|||
1666422|NCT01437397|3067466|Superiority or Other||Least squares mean difference|0.087|Standard Error of the Mean|0.018|<|0.0001|2-Sided|95.0|0.052|0.123|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates|||
1666423|NCT01437397|3067466|Superiority or Other||Least squares mean difference|0.108|Standard Error of the Mean|0.018|<|0.0001|2-Sided|95.0|0.073|0.144|||Mixed Models Analysis|Treatment, sex, smoking-status, visit and group-by-visit as factors; screening pre- and post-bronchodilator FEV1, age and baseline FEV1 as covariates|||
1666424|NCT01437098|3067525|Superiority or Other||Proportion of IF Implanted Subjects|91.7|||<|0.001|2-Sided|95.0|77.5|98.2|||Exact binomial||||
1666425|NCT01436526|3067533|Non-Inferiority or Equivalence|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2*5 mg and 1*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|111.64||||0.0685||90.0|101.14|123.23|||ANOVA||||
1666426|NCT01436526|3067534|Non-Inferiority or Equivalence|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2*5 mg and 1*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|108.19||||0.0514||90.0|101.31|115.54|||ANOVA||||
1666427|NCT01436526|3067535|Non-Inferiority or Equivalence|Using an estimated intra-subject coefficient of variation of less than 20% for AUC and Cmax, and a level of significance of 5%, a sample size of 25 completers was considered sufficient to conclude bioequivalence between 2*5 mg and 1*10 mg rivaroxaban with 90% power, if the 2 treatment means differed by 5%.|LS-Mean Ratio, Percent|108.35||||0.0438||90.0|101.59|115.57|||ANOVA||||
1666428|NCT01436396|3067561|Non-Inferiority|The non-inferiority was demonstrated if the lower limit of the 95% CI is greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.|Difference in percentage|-1.06|||||2-Sided|95.0|-2.81|0.383||||||Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).|
1668912|NCT01400932|3071291|Superiority or Other||||||<|0.001||||||Week 4; NIL|ANCOVA||||
1666429|NCT01436396|3067562|Non-Inferiority|The non-inferiority was demonstrated if the lower limit of the 95% Confidence Interval (CI) was greater than -10. The difference in percentage of seroconversion rates between group 1 and 2 was based on the Wilson score (without continuity adjustment) 95% two-sided CI.|Difference in percentage|0.334|||||2-Sided|95.0|-0.976|1.87||||||Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).|
1666430|NCT01436370|3067563|Superiority or Other|||||||0.132|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.|
1666431|NCT01436370|3067563|Superiority or Other|||||||0.705|||||||McNemar|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.|
1666432|NCT01436370|3067563|Superiority or Other|||||||0.157|||||||McNemar|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 21|
1666433|NCT01436370|3067563|Superiority or Other|||||||0.096|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.|
1666434|NCT01436370|3067563|Superiority or Other|||||||0.763|||||||McNemar|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 21.|
1666435|NCT01436370|3067563|Superiority or Other|||||||0.18|||||||McNemar|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 21.|
1666436|NCT01436370|3067564|Superiority or Other|||||||0.655|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.|
1666437|NCT01436370|3067564|Superiority or Other|||||||0.999|||||||McNemar|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.|
1666438|NCT01436370|3067564|Superiority or Other|||||||0.564|||||||McNemar|||This is the comparison for the B/Brisbane/60/2008 strain at Day 21.|
1666439|NCT01436370|3067564|Superiority or Other|||||||0.999|||||||McNemar|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 21.|
1666440|NCT01436370|3067564|Superiority or Other|||||||0.564|||||||McNemar|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 21.|
1666441|NCT01436370|3067564|Superiority or Other|||||||0.317|||||||McNemar|||This is the comparison for the B/Brisbane/60/2008 strain at Day 21.|
1666442|NCT01436370|3067566|Superiority or Other|||||||0.014|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.|
1666443|NCT01436370|3067566|Superiority or Other|||||||0.182|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.|
1666444|NCT01436370|3067566|Superiority or Other|||||||0.475|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 180.|
1666445|NCT01436370|3067566|Superiority or Other|||||||0.503|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain at Day 7.|
1666446|NCT01436370|3067566|Superiority or Other|||||||0.999|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 180.|
1666447|NCT01436370|3067566|Superiority or Other|||||||0.716|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain at Day 7.|
1666448|NCT01436370|3067567|Superiority or Other|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 180.|
1666449|NCT01436370|3067567|Superiority or Other|||||||0.999|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain at Day 7.|
1666450|NCT01436370|3067567|Superiority or Other|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 180.|
1666451|NCT01436370|3067567|Superiority or Other|||||||0.145|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain at Day 7.|
1666452|NCT01436370|3067567|Superiority or Other|||||||0.25|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain at Day 180.|
1666453|NCT01436370|3067567|Superiority or Other|||||||0.234|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain at Day 7.|
1666454|NCT01436370|3067568|Superiority or Other|||||||0.087|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain.|
1666455|NCT01436370|3067568|Superiority or Other|||||||0.5|||||||Fisher Exact|||This is the comparison for the A/Victoria/361/2011 (A/H3N2) strain.|
1666456|NCT01436370|3067568|Superiority or Other|||||||0.182|||||||Fisher Exact|||This is the comparison for the B/Wisconsin/1/2010 strain|
1666457|NCT01436370|3067576|Superiority or Other|||||||0.999|||||||Fisher Exact|||This is the comparison for the A/California/7/2009 (A/H1N1) strain.|
1666458|NCT01436370|3067576|Superiority or Other|||||||0.145|||||||Fisher Exact|||This is the comparison for the A/Perth/16/2009 (A/H3N2) strain|
1666459|NCT01436370|3067576|Superiority or Other|||||||0.145|||||||Fisher Exact|||This is the comparison for the B/Brisbane/60/2008 strain.|
1666460|NCT01436357|3067578|Superiority||Risk Difference (RD)|0.01||||0.499|2-Sided|95.0|-0.08|0.1|||Fisher Exact||||
1666461|NCT01436357|3067580|Superiority||Risk Difference (RD)|0.0||||0|2-Sided||||||Fisher Exact||||
1666462|NCT01436357|3067581|Superiority||Risk Difference (RD)|0.1||||0.015|2-Sided|95.0|0.01|0.2|||Fisher Exact||||
1666463|NCT01436357|3067582|Superiority||Risk Difference (RD)|0.08||||0.029|2-Sided|95.0|-0.01|0.16|||Fisher Exact||||
1666464|NCT01436357|3067583|Superiority||Hazard Ratio (HR)|1.529||||0.317|2-Sided|95.0|0.661|3.535|||Regression, Cox||||
1666465|NCT01436162|3067662|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.65||0.354|2-Sided|95.0|-1.9|0.7|||Mixed-effects Model for Repeat Measures||||
1666466|NCT01436162|3067663|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.92||0.583|2-Sided|95.0|-2.3|1.3|||Mixed-effects Model for Repeat Measures||||
1666467|NCT01436149|3067674|Superiority or Other||Difference in LS Mean|-0.4|Standard Error of the Mean|0.69||0.576|2-Sided|95.0|-1.8|1.0|||Mixed- effects Model for Repeat Measures||||
1666468|NCT01436149|3067675|Superiority or Other||Difference in LS Mean|0.1|Standard Error of the Mean|0.96||0.883|2-Sided|95.0|-1.7|2.0|||Mixed- effects Model for Repeat Measures||||
1666469|NCT01436110|3067681|Superiority or Other||Mean Difference (Final Values)|0.102||||0.03|2-Sided|95.0|0.01|0.194|||ANCOVA||||
1666470|NCT01436110|3067681|Superiority or Other||Mean Difference (Final Values)|0.037||||0.43|2-Sided|95.0|-0.055|0.128|||ANCOVA||||
1666471|NCT01436071|3067688|Superiority or Other||Median Difference (Final Values)|0.12||||0.012|2-Sided|95.0|0.026|0.213|||ANCOVA||||
1666472|NCT01436045|3067689|Superiority or Other||Mean Difference (Final Values)|0.92|Standard Error of the Mean|0.26|<|0.05|2-Sided||||||t-test, 2 sided|||Difference in errors [result post-insulin - result post-placebo]|
1666473|NCT01436045|3067692|Superiority or Other||Percent Change|-15.7|Standard Error of the Mean|7.0|<|0.05|2-Sided|||||RBANS Line Orientation|t-test, 2 sided||Response to intranasal Insulin Glulisine [(result post-insulin - result post-placebo)/(result post-placebo)] x 100%|Response to intranasal Insulin Gluiline [(result post-insulin - result post-placebo)/(result post-placebo)] x 100%|
1666474|NCT01435928|3067703|Superiority or Other|||||||0.056|||||||ANCOVA|LOCF|||
1666475|NCT01435928|3067704|Superiority or Other|||||||0.021|||||||ANCOVA|LOCF|||
1666476|NCT01435928|3067705|Superiority or Other|||||||0.218|||||||ANCOVA|LOCF|||
1666477|NCT01435928|3067706|Superiority or Other|||||||0.015|||||||ANCOVA|LOCF|||
1666478|NCT01435928|3067707|Superiority or Other|||||||0.029|||||||ANCOVA|LOCF|||
1666479|NCT01435928|3067708|Superiority or Other||Odds Ratio (OR)|0.75||||0.07|2-Sided|95.0|0.54|1.03|||Log Rank||||
1666480|NCT01435928|3067709|Superiority or Other||Odds Ratio (OR)|0.66||||0.039|2-Sided|95.0|0.45|0.98|||Log Rank||||
1666481|NCT01435824|3067713|Equivalence|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|107.9|||||2-Sided|90.0|84.5|137.8||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.|
1666482|NCT01435824|3067714|Equivalence|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|101.3|||||2-Sided|90.0|89.4|114.9||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.|
1666483|NCT01435824|3067715|Equivalence|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|106.2|||||2-Sided|90.0|97.5|115.7||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.|
1666484|NCT01435824|3067716|Equivalence|Bioequivalence is assessed by means of ratios of AUC, Cmax and Tmax between the comparison group and the reference group. According to a common regulatory definition, the comparison preparation (human milk-dissolved amoxicillin in this project) is considered bioequivalent to a standard preparation (water dissolved) if 90% CIs of these ratios between the two preparations for Cmax, Tmax, AUClast and AUC∞ are within a range between 0.80 and 1.25.|mean %ratio and 90% confidence interval|106.1|||||2-Sided|90.0|97.5|115.4||||||A 2x2 crossover design was chosen to examine bioequivalence of milk-based amoxicillin preparation, based on the FDA-recommended design for bioavailability studies. The recommendation suggests that 12 subjects is the minimum number of subjects acceptable for this type of design. We have decided to enrol 16 subjects to account for problems or attrition.|
1666485|NCT01435759|3067732|Superiority or Other||Least Squares Means|-0.32|Standard Error of the Mean|1.07||0.978|1-Sided|||||Any p-value <=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.30, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Logistic.|Analysis of Dose-Response Using the MCP-Mod Analysis Method|
1666486|NCT01435759|3067732|Superiority or Other||Least Squares Means|0.21|Standard Error of the Mean|1.06||0.995|1-Sided|||||Any p-value <=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.20, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Linear.|Analysis of Dose-Response Using the MCP-Mod Analysis Method.|
1666487|NCT01435759|3067732|Superiority or Other||Least Squares Means|0.43|Standard Error of the Mean|1.06||0.942|1-Sided|||||Any p-value <=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.41, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Emax.|Analysis of Dose-Response Using the MCP-Mod Analysis Method.|
1666488|NCT01435759|3067732|Superiority or Other||Least Squares Means|-0.11|Standard Error of the Mean|1.07||1|1-Sided|||||Any p-value <=0.10 indicates successful establishment of dose-response relationship.|MCP-Mod Analysis Method|The adjusted p-value was based on a critical value of 2.02 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 0.10, was based on MCP-Mod Analysis from the linear contrast using optimal coefficients for the pre-specified candidate model Betamod.|Analysis of Dose-Response Using the MCP-Mod Analysis Method|
1666489|NCT01435759|3067733|Superiority or Other||Least Squares Means|4.63|Standard Error of the Mean|1.05|<|0.001|2-Sided||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.39 was based on MCP-Mod Analysis for the candidate model Logistic2.||
1666490|NCT01435759|3067733|Superiority or Other||Least Squares Means|4.63|Standard Error of the Mean|1.05|<|0.001|2-Sided||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.39, was based on MCP-Mod Analysis for the candidate model Logistic1.||
1666491|NCT01435759|3067733|Superiority or Other||Least Squares Means|4.3|Standard Error of the Mean|1.05|<|0.001|2-Sided||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.10, was based on MCP-Mod Analysis for the candidate model Linear.||
1666492|NCT01435759|3067733|Superiority or Other||Least Squares Means|3.52|Standard Error of the Mean|1.05|<|0.002|2-Sided||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.36, was based on MCP-Mod Analysis for the candidate model Expontential.||
1666493|NCT01435759|3067733|Superiority or Other||Least Squares Means|4.45|Standard Error of the Mean|1.05|<|0.001|2-Sided||||||MCP-Mod Analysis|The pulse p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 4.24, was based on MCP-Mod Analysis for the candidate model Emax||
1666494|NCT01435759|3067734|Superiority or Other||Least Squares Means|2.37|Standard Error of the Mean|0.76||0.005|2-Sided||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.13, was based on MCP-Mod Analysis for the candidate model Logistic2.||
1666495|NCT01435759|3067734|Superiority or Other||Least Squares Means|2.22|Standard Error of the Mean|0.76||0.009|2-Sided||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.93, was based on MCP-Mod Analysis for the candidate model Logistic1.||
1666496|NCT01435759|3067734|Superiority or Other||MCP-Mod Analysis|2.47|Standard Error of the Mean|0.75||0.003|2-Sided||||||Least Squares Means|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.28, was based on MCP-Mod Analysis for the candidate model Linear.||
1666497|NCT01435759|3067734|Superiority or Other||Least Squares Means|1.95|Standard Error of the Mean|0.75||0.023|2-Sided||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.59, was based on MCP-Mod Analysis for the candidate model Exponential.||
1666498|NCT01435759|3067734|Superiority or Other||Least Squares Means|2.16|Standard Error of the Mean|0.75||0.011|2-Sided||||||MCP-Mod Analysis|The diastolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.86 was based on MCP-Mod Analysis for the candidate model Emax.||
1666499|NCT01435759|3067735|Superiority or Other||Least Squares Means|3.15|Standard Error of the Mean|1.01||0.005|2-Sided||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.12, was based on MCP-Mod Analysis for the candidate model Logistic2.||
1666500|NCT01435759|3067735|Superiority or Other||Least Squares Means|2.91|Standard Error of the Mean|1.01||0.01|2-Sided||||||MCP-Mod Analysis Method|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.88, was based on MCP-Mod Analysis for the candidate model Logistic1.||
1666501|NCT01435759|3067735|Superiority or Other||Least Squares Mean|3.28|Standard Error of the Mean|1.01||0.003|2-Sided||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.26 was based on MCP-Mod Analysis for the candidate model Linear.||
1666502|NCT01435759|3067735|Superiority or Other||Least Squares Means|2.5|Standard Error of the Mean|1.01||0.032|2-Sided||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 2.48, was based on MCP-Mod Analysis for the candidate model Exponential.||
1666503|NCT01435759|3067735|Superiority or Other||Least Squares Mean|3.16|Standard Error of the Mean|1.01||0.004|2-Sided||||||MCP-Mod Analysis|The systolic blood pressure p-value was based on a critical value of 1.99 from a multivariate-t distribution with 341 degrees of freedom.|The t-statistic used for this analysis, 3.14, was based on MCP-Mod Analysis for the candidate model EMax.||
1666504|NCT01435603|3067773|Superiority||Slope|-1.273||||0.017|2-Sided||||||Regression, Linear||||
1666505|NCT01435018|3067957|Other||Odds Ratio (OR)|0.8|||||2-Sided|95.0|0.5|1.3|||||Odds ratio for BV+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count and country.||
1666506|NCT01435018|3067958|Other||Odds Ratio (OR)|0.3|||||2-Sided|95.0|0.1|0.7|||||Odds ratio for ET+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.||
1666507|NCT01435018|3067959|Other||Hazard Ratio (HR)|1.5|||||2-Sided|95.0|1.1|2.2|||||Hazard ratio for BV+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.||
1666508|NCT01435018|3067960|Other||Hazard Ratio (HR)|1.9|||||2-Sided|95.0|1.1|3.4|||||Hazard ratio for ET+ART relative to PTX+ART adjusted for screening CD4 lymphocyte count.||
1666509|NCT01435018|3067961|Other||Cumulative rate difference|8.4|||||2-Sided|95.0|-0.4|17.2|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the cumulative rate of death with 95% two-sided confidence interval.|
1666540|NCT01434654|3068015|Superiority or Other|||||||0.58|||||||ANOVA|||Change in NAA/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1666510|NCT01435018|3067962|Other||Cumulative rate difference|14.7|||||2-Sided|95.0|-1.9|31.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the cumulative rate of death with 95% two-sided confidence interval.|
1666511|NCT01435018|3067963|Other||Cumulative rate difference|11.1|||||2-Sided|95.0|-0.4|22.7|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of change in KS treatment.|
1666512|NCT01435018|3067964|Other||Cumulative rate difference|37.5|||||2-Sided|95.0|13.6|61.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of change in KS treatment.|
1666513|NCT01435018|3067965|Other||Cumulative rate difference|17.7|||||2-Sided|95.0|6.2|29.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.|
1666514|NCT01435018|3067966|Other||Cumulative rate difference|24.2|||||2-Sided|95.0|0.9|47.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.|
1666515|NCT01435018|3067967|Other||Cumulative rate difference|18.8|||||2-Sided|95.0|6.3|31.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, or virologic failure.|
1666516|NCT01435018|3067968|Other||Cumulative rate difference|24.2|||||2-Sided|95.0|0.9|47.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, AIDS defining event, or virologic failure.|
1666517|NCT01435018|3067969|Other||Cumulative rate difference|14.4|||||2-Sided|95.0|1.8|27.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, or AIDS defining event.|
1666518|NCT01435018|3067970|Other||Cumulative rate difference|19.4|||||2-Sided|95.0|-4.1|43.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of KS progression, death, or AIDS defining event.|
1666519|NCT01435018|3067973|Other||Cumulative rate difference|5.5|||||2-Sided|95.0|-0.1|11.0|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of HIV-1 RNA virologic failure with 95% two-sided confidence interval.|
1666520|NCT01435018|3067974|Other||Cumulative rate difference|4.3|||||2-Sided|95.0|-1.9|10.6|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of HIV-1 RNA virologic failure with 95% two-sided confidence interval.|
1666521|NCT01435018|3067975|Other||Cumulative rate difference|-3.3|||||2-Sided|95.0|-13.3|6.6|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of AIDS-defining events with 95% two-sided confidence interval.|
1666522|NCT01435018|3067976|Other||Cumulative rate difference|-15.0|||||2-Sided|95.0|-34.4|4.3|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of AIDS-defining events with 95% two-sided confidence interval.|
1666523|NCT01435018|3067977|Other||Cumulative rate difference|16.3|||||2-Sided|95.0|3.7|28.8||||||Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of IERC-confirmed KS progression with 95% two-sided confidence interval.|Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.
1666524|NCT01435018|3067979|Other||Cumulative rate difference|8.4|||||2-Sided|95.0|-0.4|17.2|||||Confidence interval estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of death with 95% two-sided confidence interval.|
1666563|NCT01433913|3068068|Other|||||||0.72|||||||Wilcoxon (Mann-Whitney)||||
1666564|NCT01433913|3068069|Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)||||
1666565|NCT01433913|3068070|Other|||||||0.77|||||||Wilcoxon (Mann-Whitney)||||
1666566|NCT01433913|3068071|Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1666525|NCT01435018|3067980|Other||Cumulative rate difference|14.7|||||2-Sided|95.0|-1.9|31.4|||||Confidence interval estimation was stratified by screening CD4 lymphocyte count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative rate of death with 95% two-sided confidence interval.|
1666526|NCT01435018|3067981|Non-Inferiority|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in BV+ART is within 15% of PTX+ART. The selection of the 15% non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the “maximum treatment difference that is considered clinically irrelevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-20.1|||||2-Sided|95.0|-32.2|-7.9|||||Confidence interval estimation was stratified by country using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 cumulative PFS rate with 95% two-sided confidence interval.|
1666527|NCT01435018|3067981|Non-Inferiority|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in BV+ART is within 15% of PTX+ART. The selection of the 15% non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the “maximum treatment difference that is considered clinically irrelevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-19.8|||||2-Sided|95.0|-32.3|-7.4|||||Confidence interval estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (BV+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 PFS rate with 95% two-sided confidence interval.|
1666528|NCT01435018|3067982|Non-Inferiority|"Non-inferiority is defined as demonstrating that the 48-week PFS rate in ET+ART is within 15% of PTX+ART. The selection of the 15% non-inferiority margin was a combination of clinical judgment and statistical reasoning. A poll of the sites was conducted to derive the “maximum treatment difference that is considered clinically irrelevant (i.e. largest acceptable difference in order to gain the advantages (e.g. cost) of the experimental chemotherapy)."|Cumulative rate difference|-30.3|||||2-Sided|95.0|-52.3|-8.3|||||Confidence interval (CI) estimation was stratified by screening CD4 count using Greenwood's variance with the inverse of this variance used for the stratum weights. CI stratified by country was not performed due to small number of observations.|Treatment comparison was made using the difference (ET+ART - PTX+ART) in the stratified Kaplan-Meier estimate for the week 48 PFS rate with 95% two-sided confidence interval.|
1666529|NCT01434680|3068001|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval, the two vaccine groups would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|0.72|||<|0.05|2-Sided|95.0|0.58|0.89|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10-transformed titers and both the limits of 95% CIs||The secondary objective was to be assessed only if both primary objectives were met. Because of this, no adjustment for multiplicity was required. MenC-CRM liquid would be declared equivalent to MenC-CRM ROS if the two-sided 95% CI for the ratio of the hSBA GMTs at approximately 28 days following vaccination was within the equivalence interval (0.5, 2.0).|
1666530|NCT01434680|3068002|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons,MenC-CRM ROS and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|1.14|||<|0.05|2-Sided|95.0|0.92|1.41|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10-transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM ROS to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).|
1666531|NCT01434680|3068002|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons, MenC-CRM LIQ and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines.|hSBA GMT ratios|0.82|||<|0.05|2-Sided|95.0|0.67|1.0|||ANOVA|95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10 transformed titers and both the limits of 95% CIs||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM LIQ to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0).|
1666532|NCT01434654|3068014|Superiority or Other|||||||0.58|||||||ANOVA|||Change in Glx/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1666533|NCT01434654|3068014|Superiority or Other|||||||0.68|||||||ANOVA|||Change in mIo/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1666534|NCT01434654|3068014|Superiority or Other|||||||0.06|||||||ANOVA|||Change in Cho/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1666535|NCT01434654|3068014|Superiority or Other|||||||0.09|||||||ANOVA|||Change in Cr/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1666536|NCT01434654|3068014|Superiority or Other|||||||0.16|||||||ANOVA|||Change in NAA/H20 levels were analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1666537|NCT01434654|3068015|Superiority or Other|||||||0.98|||||||ANOVA|||Change in mIo/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1666538|NCT01434654|3068015|Superiority or Other|||||||0.86|||||||ANOVA|||Change in Cho/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1666539|NCT01434654|3068015|Superiority or Other|||||||0.44|||||||ANOVA|||Change in Cr/H20 levels was analysed using repeated-measures ANOVA with arm, time, and arm*time interaction as fixed effects.|
1666567|NCT01433913|3068072|Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)||||
1666541|NCT01434654|3068016|Superiority or Other|||||||0.99||||||P-value for arm*time interaction fixed effect.|Mixed Models Analysis|49 datapoints included from baseline, 6 months, and 12 months visits (low CNS penetrance n=14; high CNS penetrance n=35)||The primary outcome was analysed using a mixed-effect regression model with arm and time as fixed linear effects, arm*time interaction as a non-linear fixed effect and participant as a random effect to account for participant attrition.|
1666542|NCT01434290|3068038|Superiority|||||||0.86|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||[One-year VAS Score] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.|
1666543|NCT01434290|3068038|Superiority|||||||0.83|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||[One-year VAS Score] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.|
1666544|NCT01434290|3068038|Superiority|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||[One-year Index Score] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.|
1666545|NCT01434290|3068038|Superiority|||||||0.16|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||[One-year Index Score] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the non-normality of the data. Each arm analyzed separately.|
1666546|NCT01434290|3068039|Superiority|||||||0.53|||||||One sample z-test|One-sided significance level of 0.025||≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.|
1666547|NCT01434290|3068039|Superiority|||||||0.44|||||||one sampe z-test|One-sided significance level of 0.025||≤38% was considered acceptable, ≥58% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.|
1666548|NCT01434290|3068040|Superiority|||||||0.21|||||||One sample z-test|One-side significance level of 0.025||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.|
1666549|NCT01434290|3068040|Superiority|||||||0.39|||||||One-sample z-test|One-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used.|
1666550|NCT01434290|3068041|Superiority|||||||0.43|||||||Wilcoxon (Mann-Whitney)|Two-side significance level of 0.017||[Urinary one-year results] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.|
1666551|NCT01434290|3068041|Superiority|||||||0.09|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017||[Urinary one-year results] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.|
1666552|NCT01434290|3068041|Superiority|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||[Bowel one-year results] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.|
1666553|NCT01434290|3068041|Superiority|||||||0.03|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level of 0.017.||[Bowel one-year results] Originally the t-test was planned to test if the change in each arm is different from 0. Wilcoxon Mann-Whitney was used instead due to the normality of the data.|
1666554|NCT01434290|3068046|Superiority|||||||0.38|||||||One sample z-test|One-sided 0.025 significance level||≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel & urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.|
1666555|NCT01434290|3068046|Superiority|||||||0.18|||||||One sample z-test|One-sided 0.025 significance level||≤40% was considered acceptable, ≥60% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.40 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel & urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.|
1666556|NCT01434290|3068047|Superiority|||||||0.08|||||||One sample z-test|one-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel & urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.|
1666557|NCT01434290|3068047|Superiority|||||||0.19|||||||One sample z-test|One-sided 0.025 significance level||≤35% was considered acceptable, ≥55% unacceptable. Each arm analyzed separately. Average score and standard error of each arm calculated and one-sample z-test for proportion with significance level of 0.025 was used. For a given arm, if the null hypothesis of p ≤ 0.35 is rejected, then conclude that the regimen given on that arm is unacceptable. However if it not rejected for both bowel & urinary domains, then that regimen will be considered acceptable for further use in a Phase III study.|
1666558|NCT01433913|3068060|Other|||||||0.36|||||||Wilcoxon (Mann-Whitney)||||
1666559|NCT01433913|3068061|Other|||||||0.46|||||||Wilcoxon (Mann-Whitney)||||
1666560|NCT01433913|3068062|Other|||||||0.46|||||||Wilcoxon (Mann-Whitney)||||
1666561|NCT01433913|3068063|Other|||||||0.25|||||||Wilcoxon (Mann-Whitney)||||
1666562|NCT01433913|3068064|Other|||||||0.63|||||||Wilcoxon (Mann-Whitney)||||
1666568|NCT01433042|3068113|Superiority or Other||percentage|98.0|||||||||||||since the study results analysis is purley discriptive no P value and confidence interval was used for the analysis|"Primary Endpoint~o Physician’s subjective assessment questionnaire was evaluated in a quality manner.~The physicians were required to assess the performance of SB3 system as compare to SB2 by answering a short questionnaire.~The physicians were requested to indicate whether capsule SB3 was better as compared to SB2."|
1666569|NCT01432561|3068131|Superiority or Other|||||||0.05|||||||Non-parametric Hodges-Lehmann method|||High-protein compared to fasted condition|
1666570|NCT01432561|3068131|Superiority or Other|||||||0.3|||||||Non-parametric Hodges-Lehmann method|||Fed high-fat/calorie compared to fasted condition.|
1666571|NCT01432561|3068132|Superiority or Other|||||||0.036|||||||ANOVA|||High-protein compared to fasted condition|
1666572|NCT01432561|3068132|Superiority or Other|||||||0.16|||||||ANOVA|||High-fat/calorie compared to fasted condition|
1666573|NCT01432561|3068133|Superiority or Other|||||||0.005|||||||ANOVA|||High-protein compared to fasted condition|
1666574|NCT01432561|3068133|Superiority or Other|||||||0.04|||||||ANOVA|||High-fat/calorie compared to fasted condition|
1666575|NCT01432457|3068141|Superiority or Other||Adjusted Mean Difference|-0.32||||0.471|2-Sided|95.0|-1.19|0.55||p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline|ANCOVA|||The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666576|NCT01432457|3068141|Superiority or Other||Adjusted Mean Difference|-0.09||||0.837|2-Sided|95.0|-0.98|0.8||p-value was obtained from the ANCOVA model as change from baseline = Treatment + Site + Gender + Baseline|ANCOVA|||The treatment by gender interaction was first tested using an analysis of covariance (ANCOVA) model with treatment, site, gender, and treatment by gender as factors and the baseline total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666577|NCT01432457|3068142|Superiority or Other||Adjusted Odds Ratio|1.412||||0.072|2-Sided|95.0|0.969|2.057|||Regression, Logistic|||Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666578|NCT01432457|3068142|Superiority or Other||Adjusted Odds Ratio|1.105||||0.615|2-Sided|95.0|0.749|1.631|||Regression, Logistic|||Remission in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666579|NCT01432457|3068143|Superiority or Other||Adjusted Odds Ratio|1.378||||0.054|2-Sided|95.0|0.995|1.91|||Regression, Logistic|||Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666580|NCT01432457|3068143|Superiority or Other||Adjusted Odds Ratio|1.242||||0.198|2-Sided|95.0|0.893|1.726|||Regression, Logistic|||Response in HAM-D17 was analyzed based on a logistic regression model with treatment and site as fixed factors and the baseline HAM-D17 total score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666581|NCT01432457|3068144|Superiority or Other||Adjusted Mean Difference|0.22||||0.014|2-Sided|95.0|0.04|0.39|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666582|NCT01432457|3068144|Superiority or Other||Adjusted Mean Difference|0.17||||0.062|2-Sided|95.0|-0.01|0.34|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666583|NCT01432457|3068145|Superiority or Other||Adjusted Mean Difference|0.28|||<|0.001|2-Sided|95.0|0.13|0.43|||Mixed Models Analysis|||CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666584|NCT01432457|3068145|Superiority or Other||Adjusted Mean Difference|0.2|||<|0.009|2-Sided|95.0|0.05|0.34|||Mixed Models Analysis|||CGI-S was analyzed using the mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline CGI-S score as a covariate. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666585|NCT01432457|3068146|Superiority or Other||||||<|0.001||||||"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of Row Mean Scores Differences controlling for site."|Cochran-Mantel-Haenszel|||CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666586|NCT01432457|3068146|Superiority or Other||||||<|0.029||||||"p-value was obtained from the separate pair-wise Cochran-Mantel-Haenszel test versus placebo for the alternative hypothesis of Row Mean Scores Differences controlling for site."|Cochran-Mantel-Haenszel|||CGI-I was analyzed with the Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores. Each DVS SR arm was separately compared to placebo controlling for site. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666587|NCT01432457|3068147|Superiority or Other||Adjusted Mean Difference|1.67||||0.002|2-Sided|95.0|0.59|2.74|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666588|NCT01432457|3068147|Superiority or Other||Adjusted Mean Difference|1.36||||0.014|2-Sided|95.0|0.28|2.45|||ANCOVA|||To assess the sensitivity of the results to the missing data assumptions, an analysis of covariance (ANCOVA) model based on the last observation carried forward (LOCF) was used. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666589|NCT01432457|3068148|Superiority or Other||Adjusted Mean Difference|1.96|||<|0.001|2-Sided|95.0|0.84|3.08||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|Mixed Models Analysis|||A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666590|NCT01432457|3068148|Superiority or Other||Adjusted Mean Difference|1.57|||<|0.006|2-Sided|95.0|0.44|2.69||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|Mixed Models Analysis|||A mixed effects model for repeated measures (MMRM) with treatment, visit, treatment by visit interaction, and site as fixed effects, and the baseline HAM-D17 score as a covariate was used to compare DVS SR dose to placebo. The test of the null hypothesis was used study-wise with alpha = 0.05 (2-sided).|
1666591|NCT01432444|3068150|Superiority or Other||||||<|0.0001||||||Derived from t-test of mean=0.|t-test|||Statistical analysEs for Week 4, 12 and 24.|
1666592|NCT01432444|3068151|Superiority or Other||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test, 2 sided|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analysis for Week 4, 12 and 24.|
1666593|NCT01432444|3068152|Superiority or Other||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test, 2 sided|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analyses for Week 4, Week 12 and Week 24.|
1666594|NCT01432444|3068153|Superiority or Other||||||<|0.0001||||||Derived from T-test of Mean=0.|t-test|Mean duration was derived as the cumulative duration divided by the number of inpatient non-psychiatric hospitalization.||Statistical analyses for Week 4, 12 and 24.|
1666595|NCT01432444|3068154|Superiority or Other||||||<|0.0001||||||P-value was derived from Exact McNemar test.|McNemar|||Inpatient hospitalization for retrospective period (Months 4-6) and prospective period (Months 4-6) for closed or open unit.|
1666596|NCT01432275|3068180|Superiority or Other||||||<|0.0001|||||||Binomial test|Comparison to 27 participants that preferred their usual method to FreeStyle InsuLinx. Twelve(12) participants did not have a preference.|||
1666597|NCT01432236|3068192|Superiority or Other||Mean Difference (Final Values)|0.55||||0.0085|2-Sided|95.0|0.14|0.97||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666598|NCT01432236|3068194|Superiority or Other||Mean Difference (Final Values)|0.02||||0.3854|2-Sided|95.0|-0.02|0.06||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666599|NCT01432236|3068196|Superiority or Other||Mean Difference (Final Values)|-0.88||||0.0005|2-Sided|95.0|-1.37|-0.39||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analysis presented in the above table is for HADS-D (depression). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and subject within sequence and within-subject error as random factors.|
1666600|NCT01432236|3068196|Superiority or Other||Mean Difference (Final Values)|-0.95|||<|0.0001|2-Sided|95.0|-1.4|-0.5||Two-sided test with α=0.05 was used. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analysis presented in the above table is for HADS-A (anxiety). Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666601|NCT01432236|3068198|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.1139|2-Sided|95.0|-0.29|0.03||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors. Analyzed as a count variable using a generalized linear model assuming a Poisson distribution and utilizing a log link transformation.|
1666602|NCT01432236|3068199|Superiority or Other||Mean Difference (Final Values)|8.35||||0.0511|2-Sided|95.0|-0.04|16.74||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666603|NCT01432236|3068200|Superiority or Other||Mean Difference (Final Values)|-5.8||||0.0117|2-Sided|95.0|-10.29|-1.31||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors|
1666604|NCT01432236|3068201|Superiority or Other||Mean Difference (Final Values)|-7.81||||0.0018|2-Sided|95.0|-12.66|-2.96||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666605|NCT01432236|3068202|Superiority or Other||Mean Difference (Final Values)|0.57|||<|0.0001|2-Sided|95.0|0.31|0.84||This was done using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-subject error as random factors.|
1667704|NCT01421459|3069385|Superiority or Other|||||||0.69||||||P-value is for Hypoglycemic Control at 12 weeks.|ANCOVA||||
1666606|NCT01432236|3068203|Superiority or Other|||||||0.0205||||||This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Regression, Logistic|||Statistical analysis presented above is for 50% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.|
1666607|NCT01432236|3068203|Superiority or Other|||||||0.0007||||||This secondary analyses was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Regression, Logistic|||Statistical analysis presented above is for 30% responders. Analysis was conducted using a logistic regression model using sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors. Logit link transformation was used for the model.|
1666608|NCT01432236|3068204|Superiority or Other|||||||0.116||||||This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Cochran-Mantel-Haenszel|||The PGIC variable was analyzed using CMH test with modified ridit transformation.|
1666609|NCT01432236|3068205|Superiority or Other|||||||0.0637||||||This analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Cochran-Mantel-Haenszel|||The PGIC variable was analyzed using Cochran Mantel-Haenszel (CMH) test with modified ridit transformation.|
1666610|NCT01432236|3068206|Superiority or Other||Mean Difference (Final Values)|-0.92|||<|0.0001|2-Sided|95.0|-1.32|-0.53||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'depression'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666611|NCT01432236|3068206|Superiority or Other||Mean Difference (Final Values)|-0.55|||<|0.0048|2-Sided|95.0|-0.93|-0.17||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'anxiety'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666612|NCT01432236|3068206|Superiority or Other||Mean Difference (Final Values)|-0.71|||<|0.0007|2-Sided|95.0|-1.11|-0.31||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'stiffness'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666613|NCT01432236|3068206|Superiority or Other||Mean Difference (Final Values)|-0.76|||<|0.0003|2-Sided|95.0|-1.17|-0.35||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'rested'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666614|NCT01432236|3068206|Superiority or Other||Mean Difference (Final Values)|-0.44|||<|0.0315|2-Sided|95.0|-0.85|-0.04||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'fatigue'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666615|NCT01432236|3068206|Superiority or Other||Mean Difference (Final Values)|-0.64|||<|0.0006|2-Sided|95.0|-1.0|-0.28||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'pain'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666616|NCT01432236|3068206|Superiority or Other||Mean Difference (Final Values)|-0.75|||<|0.0002|2-Sided|95.0|-1.14|-0.36||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'do work'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666617|NCT01432236|3068206|Superiority or Other||Mean Difference (Final Values)|-0.59|||<|0.005|2-Sided|95.0|-1.01|-0.18||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above for parameter 'work missed'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666618|NCT01432236|3068206|Superiority or Other||Mean Difference (Final Values)|-0.85|||<|0.0014|2-Sided|95.0|-1.36|-0.33||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the parameter 'feel good'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666715|NCT01431287|3068292|Superiority or Other||Adjusted mean difference|-0.051|Standard Error of the Mean|0.039||0.1965|2-Sided|95.0|-0.129|0.026||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666619|NCT01432236|3068206|Superiority or Other||Mean Difference (Final Values)|-0.42|||<|0.0078|2-Sided|95.0|-0.74|-0.11||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for parameter 'physical impairment'. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666620|NCT01432236|3068206|Superiority or Other||Mean Difference (Final Values)|-6.6|||<|0.0001|2-Sided|95.0|-9.33|-3.87||Analysis was conducted using a two-sided test with α=0.05. No corrections to alpha to control for potential inflation of Type I error resulting from multiple comparisons were made.|Mixed Models Analysis|||Statistical analysis presented above is for the FIQ total score. Analysis was performed using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666621|NCT01432236|3068208|Superiority or Other||Mean Difference (Final Values)|-0.61||||0.0001|2-Sided|95.0|-0.91|-0.31||Primary analysis was two-sided and performed at the 0.05 significance level.|Mixed Models Analysis|Satterthwaite’s approximation was used to estimate denominator degrees of freedom.||Analysis was done using a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within-participant error as random factors.|
1666622|NCT01431989|3068217|Non-Inferiority or Equivalence|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Median Difference (Final Values)|0.125||||0.339|2-Sided|90.0|-0.125|0.375|||Wilcoxon (Mann-Whitney)|The non-parametric method included the following factors: Sequence, Formulation, Period, Formulation and Residual|||
1666623|NCT01431989|3068218|Non-Inferiority or Equivalence|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric means T/R formulation|90.03|Standard Deviation|7.51||0|2-Sided|90.0|86.96|93.12|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.||
1666624|NCT01431989|3068219|Non-Inferiority or Equivalence|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric mean T/R formulation|87.93|Standard Deviation|13.83||0.0018|2-Sided|90.0|82.55|93.65|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.||
1666625|NCT01431989|3068220|Non-Inferiority or Equivalence|Equivalence analysis. This is a bioequivalence study performed to support the register of Clamoxyl 500 mg/5 mL, according to the requirements of Brazilian Regulatory Agency - National Agency of Sanitary Surveillance (ANVISA).|Ratio Geometric mean T/R formulation|90.03|Standard Deviation|7.53||0|2-Sided|90.0|86.99|93.17|||ANOVA|ANOVA model: 1) Fixed effects: Sequence, Period, and Formulation; 2) Random effects: Volunteer (Sequence) and Residual|The ratio between the geometric means of the test (T) and reference (R) formulations was calculated. Standard deviation intra subject was obtained.||
1666626|NCT01431976|3068228|Superiority or Other||percentage of participants|35.0|||||2-Sided|95.0|15.39|59.22|||||||
1666627|NCT01431963|3068231|Superiority or Other||percentage of participants|80.0|||||2-Sided|95.0|44.39|97.48|||||The estimated value reflects the percentage of participants who were seizure free for D5 seizures.||
1666628|NCT01431963|3068231|Superiority or Other||percentage of participants|69.7|||||2-Sided|95.0|51.29|84.41|||||The estimated value reflects the percentage of participants who were seizure free for C seizures.||
1666629|NCT01431963|3068231|Superiority or Other||percentage of participants|40.5|||||2-Sided|95.0|25.63|56.72|||||The estimated value reflects the percentage of participants who were seizure free for A+B seizures.||
1666630|NCT01431963|3068231|Superiority or Other||percentage of participants|40.0|||||2-Sided|95.0|27.02|54.09|||||The estimated value reflects the percentage of participants who were seizure free for A+B+C seizures.||
1666631|NCT01431963|3068231|Superiority or Other||percentage of participants|43.1|||||2-Sided|95.0|30.85|55.96|||||The estimated value reflects the percentage of participants who were seizure free for all seizures.||
1666632|NCT01431950|3068236|Superiority or Other||Mean Difference (Final Values)|0.077||||||95.0|-0.039|0.192|||||||
1666633|NCT01431521|3068267|Superiority or Other||Least squares mean difference|-10.67|||>|0.2|2-Sided|95.0|-25.06|3.71|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate|||
1666634|NCT01431521|3068267|Superiority or Other||Least squares mean difference|-3.47|||>|0.2|2-Sided|95.0|-17.85|10.92|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate|||
1666635|NCT01431521|3068268|Superiority or Other||Least squares mean difference|-16.74||||0.028|2-Sided|95.0|-29.08|-4.4|||Linear mixed effects model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate|||
1666636|NCT01431521|3068268|Superiority or Other||Least square mean difference|-6.35|||>|0.2|2-Sided|95.0|-18.69|6.0|||Linear mixed effect model|Containing fixed effects for treatment, and predose Day 1 (baseline) as a fixed covariate|||
1666637|NCT01431521|3068269|Superiority or Other||least squares mean difference|-17.69||||0.007|2-Sided|95.0|-36.97|-7.39|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate|||
1666638|NCT01431521|3068269|Superiority or Other||Least squares mean difference|-26.67|||<|0.001|2-Sided|95.0|-36.97|-16.37|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate|||
1666639|NCT01431521|3068269|Superiority or Other||Least squares mean difference|-44.37|||<|0.001|2-Sided|95.0|-54.67|-34.07|||Linear mixed effects model|Treatment as fixed factor and predose Day 1 value, as a fixed covariate|||
1666640|NCT01431508|3068270|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Comparison of Week 12 and Baseline|
1666641|NCT01431339|3068276|Non-Inferiority or Equivalence|The non-inferiority hypothesis test is a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in response rates in the ITT population is greater than -10% the NI of dalbavancin to vancomycin/linezolid will be concluded.|Difference in Proportions|-1.5||||||95.0|-7.4|4.6|||||Confidence intervals were adjusted for fever at baseline||
1666642|NCT01431313|3068277|Other|Mixed effects model across all doses.||||||0.59|||||||Mixed Models Analysis||||
1666643|NCT01431313|3068277|Other|Mixed effects model across all doses.||||||0.21|||||||Mixed Models Analysis||||
1666644|NCT01431313|3068277|Other|Mixed effects model across all doses.|||||<|0.001|||||||Mixed Models Analysis||||
1666645|NCT01431313|3068278|Other|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.001|||||||Mixed Models Analysis||||
1666646|NCT01431313|3068278|Other|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis||||
1666647|NCT01431313|3068279|Other|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis||||
1666648|NCT01431313|3068279|Other|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis||||
1666649|NCT01431313|3068279|Other|Mixed effects model of concentrations measured at Pre-dose, 15 minutes post 45mg dose and 15 minutes post 90mg dose.|||||<|0.05|||||||Mixed Models Analysis||||
1666650|NCT01431313|3068280|Superiority|||||||0.17|||||||Wilcoxon (Mann-Whitney)||||
1666651|NCT01431313|3068280|Superiority|||||||0.04|||||||Wilcoxon (Mann-Whitney)||||
1666652|NCT01431313|3068280|Superiority|||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1666653|NCT01431313|3068281|Other|Mixed effects model across all time points.||||||0.01|||||||Mixed Models Analysis||||
1666654|NCT01431313|3068281|Other|Mixed effects model across all time points.||||||0.01|||||||Mixed Models Analysis||||
1666655|NCT01431313|3068281|Other|Mixed effects model across all time points.||||||0.8|||||||Mixed Models Analysis||||
1666656|NCT01431313|3068282|Other|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis||||
1666657|NCT01431313|3068282|Other|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis||||
1666658|NCT01431313|3068282|Other|Mixed effects model across all time points.|||||<|0.001|||||||Mixed Models Analysis||||
1666659|NCT01431313|3068284|Other|Mixed effects model across all time points.||||||0.66|||||||Mixed Models Analysis||||
1666660|NCT01431313|3068284|Other|Mixed effects model across all time points.||||||0.003|||||||Mixed Models Analysis||||
1666661|NCT01431313|3068284|Other|Mixed effects model across all time points.||||||0.002|||||||Mixed Models Analysis||||
1666662|NCT01431300|3068285|Superiority or Other||Mean Difference (Final Values)|43.0|Standard Deviation|19.0|<|0.01||95.0|||||t-test, 2 sided|||contrast-to-noise (CNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.|
1666663|NCT01431300|3068285|Superiority or Other||Mean Difference (Final Values)|54.0|Standard Deviation|12.0|<|0.01|2-Sided|95.0|||||t-test, 2 sided|||signal-to-noise (SNR) ratios of the central veins in the 0.01 mmol/kg and 0.03mmol/kg dose groups were compared.|
1666664|NCT01431287|3068287|Superiority or Other||Adjusted mean difference|0.286|Standard Error of the Mean|0.142||0.0442|2-Sided|95.0|0.007|0.564||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666665|NCT01431287|3068287|Superiority or Other||Adjusted mean difference|0.039|Standard Error of the Mean|0.142||0.7855|2-Sided|95.0|-0.24|0.317||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666666|NCT01431287|3068287|Superiority or Other||Adjusted mean difference|0.325|Standard Error of the Mean|0.143||0.023|2-Sided|95.0|0.045|0.605||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666667|NCT01431287|3068287|Superiority or Other||Adjusted mean difference|0.608|Standard Error of the Mean|0.141|<|0.0001|2-Sided|95.0|0.332|0.884||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666668|NCT01431287|3068287|Superiority or Other||Adjusted mean difference|0.276|Standard Error of the Mean|0.14|<|0.0492|2-Sided|95.0|0.001|0.551||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666669|NCT01431287|3068287|Superiority or Other||Adjusted mean difference|0.046|Standard Error of the Mean|0.142|<|0.7441|2-Sided|95.0|-0.231|0.324||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666670|NCT01431287|3068287|Superiority or Other||Adjusted mean difference|0.332|Standard Error of the Mean|0.141|<|0.0186|2-Sided|95.0|0.056|0.609||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666671|NCT01431287|3068287|Superiority or Other||Adjusted mean difference|0.371|Standard Error of the Mean|0.142|<|0.0089|2-Sided|95.0|0.093|0.649||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666672|NCT01431287|3068287|Superiority or Other||Adjusted mean difference|0.322|Standard Error of the Mean|0.141|<|0.0226|2-Sided|95.0|0.045|0.6||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666673|NCT01431287|3068287|Superiority or Other||Adjusted mean difference|0.647|Standard Error of the Mean|0.142|<|0.0001|2-Sided|95.0|0.37|0.925||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666674|NCT01431287|3068288|Superiority or Other||djusted mean difference|0.004|Standard Error of the Mean|0.138||0.9765|2-Sided|95.0|-0.265|0.274||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666675|NCT01431287|3068288|Superiority or Other||Adjusted mean difference|0.192|Standard Error of the Mean|0.137||0.1626|2-Sided|95.0|-0.077|0.461||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666676|NCT01431287|3068288|Superiority or Other||Adjusted mean difference|0.196|Standard Error of the Mean|0.137||0.1542|2-Sided|95.0|-0.074|0.465||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666677|NCT01431287|3068288|Superiority or Other||Adjusted mean difference|0.438|Standard Error of the Mean|0.137||0.0014|2-Sided|95.0|0.17|0.707||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666678|NCT01431287|3068288|Superiority or Other||Adjusted mean difference|0.211|Standard Error of the Mean|0.136||0.122|2-Sided|95.0|-0.056|0.478||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666679|NCT01431287|3068288|Superiority or Other||Adjusted mean difference|0.223|Standard Error of the Mean|0.137||0.1029|2-Sided|95.0|-0.045|0.492||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666680|NCT01431287|3068288|Superiority or Other||Adjusted mean difference|0.227|Standard Error of the Mean|0.137||0.0966|2-Sided|95.0|-0.041|0.495||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666681|NCT01431287|3068288|Superiority or Other||Adjusted mean difference|0.419|Standard Error of the Mean|0.137||0.0022|2-Sided|95.0|0.151|0.687||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666682|NCT01431287|3068288|Superiority or Other||Adjusted mean difference|0.434|Standard Error of the Mean|0.137||0.0015|2-Sided|95.0|0.166|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666683|NCT01431287|3068288|Superiority or Other||Adjusted mean difference|0.63|Standard Error of the Mean|0.137|<|0.0001|2-Sided|95.0|0.362|0.898||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666684|NCT01431287|3068289|Superiority or Other||Adjusted mean difference|-0.022|Standard Error of the Mean|0.137||0.8709|2-Sided|95.0|-0.29|0.246||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666685|NCT01431287|3068289|Superiority or Other||Adjusted mean difference|-0.023|Standard Error of the Mean|0.136||0.8687|2-Sided|95.0|-0.29|0.245||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666686|NCT01431287|3068289|Superiority or Other||Adjusted mean difference|-0.045|Standard Error of the Mean|0.137||0.7432|2-Sided|95.0|-0.313|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666687|NCT01431287|3068289|Superiority or Other||Adjusted mean difference|0.618|Standard Error of the Mean|0.136|<|0.0001|2-Sided|95.0|0.351|0.885||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666688|NCT01431287|3068289|Superiority or Other||Adjusted mean difference|0.172|Standard Error of the Mean|0.136|<|0.2045|2-Sided|95.0|-0.094|0.438||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666689|NCT01431287|3068289|Superiority or Other||Adjusted mean difference|0.468|Standard Error of the Mean|0.136|<|0.0006|2-Sided|95.0|0.201|0.735||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666690|NCT01431287|3068289|Superiority or Other||Adjusted mean difference|0.446|Standard Error of the Mean|0.136|<|0.0011|2-Sided|95.0|0.179|0.712||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666691|NCT01431287|3068289|Superiority or Other||Adjusted mean difference|0.423|Standard Error of the Mean|0.136|<|0.0019|2-Sided|95.0|0.156|0.69||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666692|NCT01431287|3068289|Superiority or Other||Adjusted mean difference|0.64|Standard Error of the Mean|0.136|<|0.0001|2-Sided|95.0|0.373|0.907||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666693|NCT01431287|3068289|Superiority or Other||Adjusted mean difference|0.595|Standard Error of the Mean|0.136|<|0.0001|2-Sided|95.0|0.329|0.862||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666694|NCT01431287|3068290|Superiority or Other||Adjusted mean difference|-0.027|Standard Error of the Mean|0.58||0.9624|2-Sided|95.0|-1.164|1.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666695|NCT01431287|3068290|Superiority or Other||Adjusted mean difference|-1.381|Standard Error of the Mean|0.582||0.0177|2-Sided|95.0|-2.521|-0.24||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666696|NCT01431287|3068290|Superiority or Other||Adjusted mean difference|-1.408|Standard Error of the Mean|0.583||0.0158|2-Sided|95.0|-2.551|-0.265||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666697|NCT01431287|3068290|Superiority or Other||Adjusted mean difference|-0.471|Standard Error of the Mean|0.575||0.4126|2-Sided|95.0|-1.598|0.656||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666698|NCT01431287|3068290|Superiority or Other||Adjusted mean difference|-0.415|Standard Error of the Mean|0.57||0.4669|2-Sided|95.0|-1.533|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666699|NCT01431287|3068290|Superiority or Other||Adjusted mean difference|-0.029|Standard Error of the Mean|0.576||0.9602|2-Sided|95.0|-1.157|1.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666716|NCT01431287|3068292|Superiority or Other||Adjusted mean difference|0.012|Standard Error of the Mean|0.041||0.7784|2-Sided|95.0|-0.069|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666717|NCT01431287|3068292|Superiority or Other||Adjusted mean difference|0.188|Standard Error of the Mean|0.041|<|0.0001|2-Sided|95.0|0.108|0.269||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666700|NCT01431287|3068290|Superiority or Other||Adjusted mean difference|-0.056|Standard Error of the Mean|0.574||0.9222|2-Sided|95.0|-1.182|1.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666701|NCT01431287|3068290|Superiority or Other||Adjusted mean difference|-1.437|Standard Error of the Mean|0.578||0.0129|2-Sided|95.0|-2.569|-0.304||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666702|NCT01431287|3068290|Superiority or Other||Adjusted mean difference|-0.444|Standard Error of the Mean|0.576||0.4413|2-Sided|95.0|-1.573|0.686||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666703|NCT01431287|3068290|Superiority or Other||Adjusted mean difference|-1.852|Standard Error of the Mean|0.578||0.0014|2-Sided|95.0|-2.985|-0.718||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within-patient errors.||
1666704|NCT01431287|3068291|Superiority or Other||Adjusted mean difference|0.001|Standard Error of the Mean|0.563||0.9983|2-Sided|95.0|-1.102|1.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666705|NCT01431287|3068291|Superiority or Other||Adjusted mean difference|-1.011|Standard Error of the Mean|0.563||0.0724|2-Sided|95.0|-2.114|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666706|NCT01431287|3068291|Superiority or Other||Adjusted mean difference|-1.01|Standard Error of the Mean|0.563||0.0732|2-Sided|95.0|-2.114|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666707|NCT01431287|3068291|Superiority or Other||Adjusted mean difference|-1.13|Standard Error of the Mean|0.559||0.0434|2-Sided|95.0|-2.227|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666708|NCT01431287|3068291|Superiority or Other||Adjusted mean difference|-0.613|Standard Error of the Mean|0.556||0.2697|2-Sided|95.0|-1.702|0.476||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666709|NCT01431287|3068291|Superiority or Other||Adjusted mean difference|-0.518|Standard Error of the Mean|0.559||0.3542|2-Sided|95.0|-1.614|0.578||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666710|NCT01431287|3068291|Superiority or Other||Adjusted mean difference|-0.517|Standard Error of the Mean|0.558||0.3545|2-Sided|95.0|-1.611|0.577||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666711|NCT01431287|3068291|Superiority or Other||Adjusted mean difference|-1.528|Standard Error of the Mean|0.559||0.0063|2-Sided|95.0|-2.623|-0.432||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666712|NCT01431287|3068291|Superiority or Other||Adjusted mean difference|-1.131|Standard Error of the Mean|0.56||0.0435|2-Sided|95.0|-2.23|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666713|NCT01431287|3068291|Superiority or Other||Adjusted mean difference|-2.141|Standard Error of the Mean|0.56||0.0001|2-Sided|95.0|-3.239|-1.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666714|NCT01431287|3068292|Superiority or Other||Adjusted mean difference|0.063|Standard Error of the Mean|0.041||0.1315|2-Sided|95.0|-0.019|0.144||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1667705|NCT01421459|3069385|Superiority or Other|||||||0.507||||||P-value is for Hypoglycemic Control at 4 weeks.|ANCOVA||||
1666718|NCT01431287|3068292|Superiority or Other||Adjusted mean difference|0.032|Standard Error of the Mean|0.041|<|0.4393|2-Sided|95.0|-0.049|0.113||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666719|NCT01431287|3068292|Superiority or Other||Adjusted mean difference|0.094|Standard Error of the Mean|0.042|<|0.0255|2-Sided|95.0|0.011|0.176||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666720|NCT01431287|3068292|Superiority or Other||Adjusted mean difference|0.156|Standard Error of the Mean|0.04|<|0.0001|2-Sided|95.0|0.077|0.235||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666721|NCT01431287|3068292|Superiority or Other||Adjusted mean difference|0.105|Standard Error of the Mean|0.04|<|0.0085|2-Sided|95.0|0.027|0.183||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666722|NCT01431287|3068292|Superiority or Other||Adjusted mean difference|0.126|Standard Error of the Mean|0.043|<|0.0032|2-Sided|95.0|0.042|0.209||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666723|NCT01431287|3068292|Superiority or Other||Adjusted mean difference|0.137|Standard Error of the Mean|0.041|<|0.0008|2-Sided|95.0|0.057|0.217||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666724|NCT01431287|3068293|Superiority or Other||Adjusted mean difference|0.068|Standard Error of the Mean|0.043||0.1188|2-Sided|95.0|-0.017|0.153||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666725|NCT01431287|3068293|Superiority or Other||Adjusted mean difference|-0.047|Standard Error of the Mean|0.041||0.253|2-Sided|95.0|-0.129|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666726|NCT01431287|3068293|Superiority or Other||Adjusted mean difference|0.021|Standard Error of the Mean|0.043||0.6335|2-Sided|95.0|-0.064|0.105||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666727|NCT01431287|3068293|Superiority or Other||Adjusted mean difference|0.208|Standard Error of the Mean|0.043|<|0.0001|2-Sided|95.0|0.124|0.293||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666728|NCT01431287|3068293|Superiority or Other||Adjusted mean difference|0.032|Standard Error of the Mean|0.043|<|0.4581|2-Sided|95.0|-0.053|0.118||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666729|NCT01431287|3068293|Superiority or Other||Adjusted mean difference|0.108|Standard Error of the Mean|0.044|<|0.0141|2-Sided|95.0|0.022|0.194||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666730|NCT01431287|3068293|Superiority or Other||Adjusted mean difference|0.176|Standard Error of the Mean|0.042|<|0.0001|2-Sided|95.0|0.093|0.259||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666731|NCT01431287|3068293|Superiority or Other||Adjusted mean difference|0.128|Standard Error of the Mean|0.042|<|0.0022|2-Sided|95.0|0.046|0.21||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666732|NCT01431287|3068293|Superiority or Other||Adjusted mean difference|0.14|Standard Error of the Mean|0.045|<|0.0017|2-Sided|95.0|0.053|0.228||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666733|NCT01431287|3068293|Superiority or Other||Adjusted mean difference|0.161|Standard Error of the Mean|0.043|<|0.0002|2-Sided|95.0|0.077|0.244||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666734|NCT01431287|3068294|Superiority or Other||Adjusted mean difference|0.017|Standard Error of the Mean|0.021||0.4374|2-Sided|95.0|-0.025|0.059||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666735|NCT01431287|3068294|Superiority or Other||Adjusted mean difference|-0.024|Standard Error of the Mean|0.02||0.2332|2-Sided|95.0|-0.065|0.016||Comments ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666736|NCT01431287|3068294|Superiority or Other||Adjusted mean difference|-0.008|Standard Error of the Mean|0.021||0.7116|2-Sided|95.0|-0.049|0.034||Comments ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666737|NCT01431287|3068294|Superiority or Other||Adjusted mean difference|0.122|Standard Error of the Mean|0.021|<|0.0001|2-Sided|95.0|0.081|0.164||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666738|NCT01431287|3068294|Superiority or Other||Adjusted mean difference|0.047|Standard Error of the Mean|0.021|<|0.0277|2-Sided|95.0|0.005|0.089||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666739|NCT01431287|3068294|Superiority or Other||Adjusted mean difference|0.059|Standard Error of the Mean|0.022|<|0.0065|2-Sided|95.0|0.016|0.101||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666740|NCT01431287|3068294|Superiority or Other||Adjusted mean difference|0.075|Standard Error of the Mean|0.021|<|0.0003|2-Sided|95.0|0.035|0.116||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666741|NCT01431287|3068294|Superiority or Other||Adjusted mean difference|0.051|Standard Error of the Mean|0.021|<|0.0136|2-Sided|95.0|0.01|0.091||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666742|NCT01431287|3068294|Superiority or Other||Adjusted mean difference|0.106|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.063|0.149||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666743|NCT01431287|3068294|Superiority or Other||Adjusted mean difference|0.098|Standard Error of the Mean|0.021|<|0.0001|2-Sided|95.0|0.057|0.139||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666744|NCT01431287|3068295|Superiority or Other||Adjusted mean difference|0.018|Standard Error of the Mean|0.023||0.4311|2-Sided|95.0|-0.027|0.063||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666745|NCT01431287|3068295|Superiority or Other||Adjusted mean difference|-0.022|Standard Error of the Mean|0.022||0.3048|2-Sided|95.0|-0.065|0.02||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666746|NCT01431287|3068295|Superiority or Other||Adjusted mean difference|-0.004|Standard Error of the Mean|0.023||0.8428|2-Sided|95.0|-0.049|0.04||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666747|NCT01431287|3068295|Superiority or Other||Adjusted mean difference|0.141|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.097|0.185||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666748|NCT01431287|3068295|Superiority or Other||Adjusted mean difference|0.047|Standard Error of the Mean|0.023|<|0.0384|2-Sided|95.0|0.003|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666749|NCT01431287|3068295|Superiority or Other||Adjusted mean difference|0.076|Standard Error of the Mean|0.023|<|0.001|2-Sided|95.0|0.031|0.121||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666750|NCT01431287|3068295|Superiority or Other||Adjusted mean difference|0.094|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.05|0.137||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666751|NCT01431287|3068295|Superiority or Other||Adjusted mean difference|0.071|Standard Error of the Mean|0.022|<|0.0012|2-Sided|95.0|0.028|0.114||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666752|NCT01431287|3068295|Superiority or Other||Adjusted mean difference|0.123|Standard Error of the Mean|0.023|<|0.0001|2-Sided|95.0|0.077|0.169||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666753|NCT01431287|3068295|Superiority or Other||Adjusted mean difference|0.118|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.074|0.162||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||||
1666754|NCT01431287|3068296|Superiority or Other||Adjusted mean difference|0.001|Standard Error of the Mean|0.027||0.9627|2-Sided|95.0|-0.051|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666755|NCT01431287|3068296|Superiority or Other||Adjusted mean difference|0.069|Standard Error of the Mean|0.027||0.0108|2-Sided|95.0|0.016|0.121||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666756|NCT01431287|3068296|Superiority or Other||Adjusted mean difference|0.07|Standard Error of the Mean|0.027||0.0095|2-Sided|95.0|0.017|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666757|NCT01431287|3068296|Superiority or Other||Adjusted mean difference|0.088|Standard Error of the Mean|0.027||0.0011|2-Sided|95.0|0.035|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666758|NCT01431287|3068296|Superiority or Other||Adjusted mean difference|-0.014|Standard Error of the Mean|0.027||0.6093|2-Sided|95.0|-0.066|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666759|NCT01431287|3068296|Superiority or Other||Adjusted mean difference|0.1|Standard Error of the Mean|0.027||0.0002|2-Sided|95.0|0.048|0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666760|NCT01431287|3068296|Superiority or Other||Adjusted mean difference|0.102|Standard Error of the Mean|0.027||0.0001|2-Sided|95.0|0.049|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666761|NCT01431287|3068296|Superiority or Other||Adjusted mean difference|0.17|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.118|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666762|NCT01431287|3068296|Superiority or Other||Adjusted mean difference|0.087|Standard Error of the Mean|0.027|<|0.0013|2-Sided|95.0|0.034|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666763|NCT01431287|3068296|Superiority or Other||Adjusted mean difference|0.156|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.104|0.209||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666764|NCT01431287|3068297|Superiority or Other||Adjusted mean difference|0.039|Standard Error of the Mean|0.025||0.1266|2-Sided|95.0|-0.011|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666765|NCT01431287|3068297|Superiority or Other||Adjusted mean difference|0.048|Standard Error of the Mean|0.025||0.0621|2-Sided|95.0|-0.002|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1667015|NCT01431274|3068322|Superiority or Other||Adjusted mean difference|-0.051|Standard Error of the Mean|0.039||0.1965|2-Sided|95.0|-0.129|0.026||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).||
1666766|NCT01431287|3068297|Superiority or Other||Adjusted mean difference|0.086|Standard Error of the Mean|0.025||0.0007|2-Sided|95.0|0.037|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666767|NCT01431287|3068297|Superiority or Other||Adjusted mean difference|0.111|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.061|0.16||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666768|NCT01431287|3068297|Superiority or Other||Adjusted mean difference|0.008|Standard Error of the Mean|0.025|<|0.7577|2-Sided|95.0|-0.042|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom|spatial power covariance structure for within-patient errors||
1666769|NCT01431287|3068297|Superiority or Other||Adjusted mean difference|0.064|Standard Error of the Mean|0.025|<|0.0116|2-Sided|95.0|0.014|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666770|NCT01431287|3068297|Superiority or Other||Adjusted mean difference|0.103|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.053|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666771|NCT01431287|3068297|Superiority or Other||Adjusted mean difference|0.15|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.101|0.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666772|NCT01431287|3068297|Superiority or Other||Adjusted mean difference|0.072|Standard Error of the Mean|0.025|<|0.0048|2-Sided|95.0|0.022|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666773|NCT01431287|3068297|Superiority or Other||Adjusted mean difference|0.158|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.108|0.208||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666774|NCT01431287|3068298|Superiority or Other||Adjusted mean difference|0.006|Standard Error of the Mean|0.026||0.8241|2-Sided|95.0|-0.045|0.057||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666775|NCT01431287|3068298|Superiority or Other||Adjusted mean difference|0.115|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.064|0.166||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666776|NCT01431287|3068298|Superiority or Other||Adjusted mean difference|0.121|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.07|0.172||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666777|NCT01431287|3068298|Superiority or Other||Adjusted mean difference|0.095|Standard Error of the Mean|0.026|<|0.0003|2-Sided|95.0|0.044|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666778|NCT01431287|3068298|Superiority or Other||Adjusted mean difference|0.028|Standard Error of the Mean|0.026|<|0.2888|2-Sided|95.0|-0.023|0.079||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666779|NCT01431287|3068298|Superiority or Other||Adjusted mean difference|0.062|Standard Error of the Mean|0.026|<|0.0174|2-Sided|95.0|0.011|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666780|NCT01431287|3068298|Superiority or Other||Adjusted mean difference|0.068|Standard Error of the Mean|0.026|<|0.0094|2-Sided|95.0|0.017|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666781|NCT01431287|3068298|Superiority or Other||Adjusted mean difference|0.183|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.132|0.234||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666782|NCT01431287|3068298|Superiority or Other||Adjusted mean difference|0.089|Standard Error of the Mean|0.026|<|0.0006|2-Sided|95.0|0.038|0.141||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666783|NCT01431287|3068298|Superiority or Other||Adjusted mean difference|0.21|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.159|0.261||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666784|NCT01431287|3068299|Superiority or Other||Adjusted mean difference|0.017|Standard Error of the Mean|0.026||0.5159|2-Sided|95.0|-0.034|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666785|NCT01431287|3068299|Superiority or Other||Adjusted mean difference|0.077|Standard Error of the Mean|0.026||0.003|2-Sided|95.0|0.026|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666786|NCT01431287|3068299|Superiority or Other||Adjusted mean difference|0.094|Standard Error of the Mean|0.026||0.0003|2-Sided|95.0|0.043|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666787|NCT01431287|3068299|Superiority or Other||Adjusted mean difference|0.088|Standard Error of the Mean|0.026||0.0007|2-Sided|95.0|0.037|0.138||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666788|NCT01431287|3068299|Superiority or Other||Adjusted mean difference|0.012|Standard Error of the Mean|0.026||0.6413|2-Sided|95.0|-0.039|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666789|NCT01431287|3068299|Superiority or Other||Adjusted mean difference|0.059|Standard Error of the Mean|0.026||0.0233|2-Sided|95.0|0.008|0.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666790|NCT01431287|3068299|Superiority or Other||Adjusted mean difference|0.075|Standard Error of the Mean|0.026||0.0035|2-Sided|95.0|0.025|0.126||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666791|NCT01431287|3068299|Superiority or Other||Adjusted mean difference|0.152|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.102|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666792|NCT01431287|3068299|Superiority or Other||Adjusted mean difference|0.071|Standard Error of the Mean|0.026|<|0.0064|2-Sided|95.0|0.02|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666793|NCT01431287|3068299|Superiority or Other||Adjusted mean difference|0.164|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.114|0.215||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666794|NCT01431287|3068300|Superiority or Other||Adjusted mean difference|0.013|Standard Error of the Mean|0.026||0.6148|2-Sided|95.0|-0.038|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666795|NCT01431287|3068300|Superiority or Other||Adjusted mean difference|0.047|Standard Error of the Mean|0.026||0.0708|2-Sided|95.0|-0.004|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666796|NCT01431287|3068300|Superiority or Other||Adjusted mean difference|0.059|Standard Error of the Mean|0.026||0.0209|2-Sided|95.0|0.009|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666797|NCT01431287|3068300|Superiority or Other||Adjusted mean difference|0.076|Standard Error of the Mean|0.026||0.0034|2-Sided|95.0|0.025|0.126||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666798|NCT01431287|3068300|Superiority or Other||Adjusted mean difference|-0.008|Standard Error of the Mean|0.026||0.7518|2-Sided|95.0|-0.059|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666799|NCT01431287|3068300|Superiority or Other||Adjusted mean difference|0.071|Standard Error of the Mean|0.026||0.0061|2-Sided|95.0|0.02|0.121||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666800|NCT01431287|3068300|Superiority or Other||Adjusted mean difference|0.084|Standard Error of the Mean|0.026||0.0012|2-Sided|95.0|0.033|0.134||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666801|NCT01431287|3068300|Superiority or Other||Adjusted mean difference|0.13|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.08|0.181||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666802|NCT01431287|3068300|Superiority or Other||Adjusted mean difference|0.063|Standard Error of the Mean|0.026|<|0.0154|2-Sided|95.0|0.012|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666803|NCT01431287|3068300|Superiority or Other||Adjusted mean difference|0.122|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.072|0.173||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666804|NCT01431287|3068301|Superiority or Other||Adjusted mean difference|-0.018|Standard Error of the Mean|0.026||0.4908|2-Sided|95.0|-0.069|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666805|NCT01431287|3068301|Superiority or Other||Adjusted mean difference|0.037|Standard Error of the Mean|0.026||0.1613|2-Sided|95.0|-0.015|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666806|NCT01431287|3068301|Superiority or Other||Adjusted mean difference|0.019|Standard Error of the Mean|0.026||0.4763|2-Sided|95.0|-0.033|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666807|NCT01431287|3068301|Superiority or Other||Adjusted mean difference|0.165|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.114|0.216||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666808|NCT01431287|3068301|Superiority or Other||Adjusted mean difference|-0.016|Standard Error of the Mean|0.026|<|0.5373|2-Sided|95.0|-0.067|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666809|NCT01431287|3068301|Superiority or Other||Adjusted mean difference|0.199|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.148|0.25||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666810|NCT01431287|3068301|Superiority or Other||Adjusted mean difference|0.181|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.13|0.232||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day^interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666811|NCT01431287|3068301|Superiority or Other||Adjusted mean difference|0.218|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.167|0.269||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666812|NCT01431287|3068301|Superiority or Other||Adjusted mean difference|0.183|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.132|0.234||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666813|NCT01431287|3068301|Superiority or Other||Adjusted mean difference|0.202|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.15|0.253||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666814|NCT01431287|3068302|Superiority or Other||Adjusted mean difference|0.036|Standard Error of the Mean|0.026||0.1569|2-Sided|95.0|-0.014|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666815|NCT01431287|3068302|Superiority or Other||Adjusted mean difference|0.015|Standard Error of the Mean|0.026||0.5514|2-Sided|95.0|-0.035|0.065||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666816|NCT01431287|3068302|Superiority or Other||Adjusted mean difference|0.051|Standard Error of the Mean|0.026||0.0442|2-Sided|95.0|0.001|0.102||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666817|NCT01431287|3068302|Superiority or Other||Adjusted mean difference|0.183|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.132|0.233||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666818|NCT01431287|3068302|Superiority or Other||Adjusted mean difference|-0.01|Standard Error of the Mean|0.025|<|0.698|2-Sided|95.0|-0.06|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666819|NCT01431287|3068302|Superiority or Other||Adjusted mean difference|0.156|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.106|0.206||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666820|NCT01431287|3068302|Superiority or Other||Adjusted mean difference|0.193|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.143|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666821|NCT01431287|3068302|Superiority or Other||Adjusted mean difference|0.208|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.158|0.258||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666822|NCT01431287|3068302|Superiority or Other||Adjusted mean difference|0.146|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.096|0.197||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666823|NCT01431287|3068302|Superiority or Other||Adjusted mean difference|0.198|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.148|0.248||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666824|NCT01431287|3068303|Superiority or Other||Adjusted mean difference|0.02|Standard Error of the Mean|0.025||0.4343|2-Sided|95.0|-0.03|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666825|NCT01431287|3068303|Superiority or Other||Adjusted mean difference|0.056|Standard Error of the Mean|0.025||0.0269|2-Sided|95.0|0.006|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666826|NCT01431287|3068303|Superiority or Other||Adjusted mean difference|0.076|Standard Error of the Mean|0.025||0.0027|2-Sided|95.0|0.026|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666827|NCT01431287|3068303|Superiority or Other||Adjusted mean difference|0.163|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.114|0.213||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666828|NCT01431287|3068303|Superiority or Other||Adjusted mean difference|0.01|Standard Error of the Mean|0.025|<|0.6974|2-Sided|95.0|-0.04|0.059||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666829|NCT01431287|3068303|Superiority or Other||Adjusted mean difference|0.134|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.084|0.183||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666830|NCT01431287|3068303|Superiority or Other||Adjusted mean difference|0.153|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.104|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666831|NCT01431287|3068303|Superiority or Other||Adjusted mean difference|0.209|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.16|0.258||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666832|NCT01431287|3068303|Superiority or Other||Adjusted mean difference|0.143|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.094|0.193||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666833|NCT01431287|3068303|Superiority or Other||Adjusted mean difference|0.219|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.169|0.268||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666834|NCT01431287|3068304|Superiority or Other||Adjusted mean difference|0.034|Standard Error of the Mean|0.025||0.1774|2-Sided|95.0|-0.015|0.083||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666835|NCT01431287|3068304|Superiority or Other||Adjusted mean difference|-0.077|Standard Error of the Mean|0.025||0.002|2-Sided|95.0|-0.126|-0.028||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666836|NCT01431287|3068304|Superiority or Other||Adjusted mean difference|-0.043|Standard Error of the Mean|0.025||0.0822|2-Sided|95.0|-0.092|0.006||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666837|NCT01431287|3068304|Superiority or Other||Adjusted mean difference|0.133|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.084|0.182||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666838|NCT01431287|3068304|Superiority or Other||Adjusted mean difference|-0.014|Standard Error of the Mean|0.025|<|0.5831|2-Sided|95.0|-0.063|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666839|NCT01431287|3068304|Superiority or Other||Adjusted mean difference|0.113|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.064|0.162||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666840|NCT01431287|3068304|Superiority or Other||Adjusted mean difference|0.147|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.098|0.196||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666841|NCT01431287|3068304|Superiority or Other||Adjusted mean difference|0.07|Standard Error of the Mean|0.025|<|0.0049|2-Sided|95.0|0.021|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666842|NCT01431287|3068304|Superiority or Other||Adjusted mean difference|0.1|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.051|0.148||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666843|NCT01431287|3068304|Superiority or Other||Adjusted mean difference|0.056|Standard Error of the Mean|0.025|<|0.0241|2-Sided|95.0|0.007|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666844|NCT01431287|3068305|Superiority or Other||Adjusted mean difference|0.018|Standard Error of the Mean|0.013||0.1764|2-Sided|95.0|-0.008|0.044||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666845|NCT01431287|3068305|Superiority or Other||Adjusted mean difference|0.01|Standard Error of the Mean|0.013||0.4327|2-Sided|95.0|-0.016|0.037||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666846|NCT01431287|3068305|Superiority or Other||Adjusted mean difference|0.028|Standard Error of the Mean|0.013||0.033|2-Sided|95.0|0.002|0.055||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666847|NCT01431287|3068305|Superiority or Other||Adjusted mean difference|0.071|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.045|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666848|NCT01431287|3068305|Superiority or Other||Adjusted mean difference|0.016|Standard Error of the Mean|0.013|<|0.2273|2-Sided|95.0|-0.01|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666849|NCT01431287|3068305|Superiority or Other||Adjusted mean difference|0.037|Standard Error of the Mean|0.013|<|0.0052|2-Sided|95.0|0.011|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666850|NCT01431287|3068305|Superiority or Other||Adjusted mean difference|0.055|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.029|0.081||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666851|NCT01431287|3068305|Superiority or Other||Adjusted mean difference|0.065|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.039|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666852|NCT01431287|3068305|Superiority or Other||Adjusted mean difference|0.053|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.027|0.079||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666853|NCT01431287|3068305|Superiority or Other||Adjusted mean difference|0.081|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.055|0.108||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666854|NCT01431287|3068306|Superiority or Other||Adjusted mean difference|0.027|Standard Error of the Mean|0.013||0.0381|2-Sided|95.0|0.001|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666855|NCT01431287|3068306|Superiority or Other||Adjusted mean difference|0.007|Standard Error of the Mean|0.013||0.5744|2-Sided|95.0|-0.018|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666856|NCT01431287|3068306|Superiority or Other||Adjusted mean difference|0.035|Standard Error of the Mean|0.013||0.0083|2-Sided|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666857|NCT01431287|3068306|Superiority or Other||Adjusted mean difference|0.078|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.052|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666858|NCT01431287|3068306|Superiority or Other||Adjusted mean difference|0.008|Standard Error of the Mean|0.013|<|0.5274|2-Sided|95.0|-0.017|0.034||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666859|NCT01431287|3068306|Superiority or Other||Adjusted mean difference|0.042|Standard Error of the Mean|0.013|<|0.0013|2-Sided|95.0|0.016|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666860|NCT01431287|3068306|Superiority or Other||Adjusted mean difference|0.069|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.044|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666861|NCT01431287|3068306|Superiority or Other||Adjusted mean difference|0.077|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.051|0.102||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666862|NCT01431287|3068306|Superiority or Other||Adjusted mean difference|0.05|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.025|0.076||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666863|NCT01431287|3068306|Superiority or Other||Adjusted mean difference|0.085|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.059|0.111||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666864|NCT01431287|3068307|Superiority or Other||Adjusted mean difference|0.007|Standard Error of the Mean|0.013||0.611|2-Sided|95.0|-0.019|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666865|NCT01431287|3068307|Superiority or Other||Adjusted mean difference|0.034|Standard Error of the Mean|0.013||0.0081|2-Sided|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666866|NCT01431287|3068307|Superiority or Other||Adjusted mean difference|0.041|Standard Error of the Mean|0.013||0.0016|2-Sided|95.0|0.016|0.066||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666867|NCT01431287|3068307|Superiority or Other||Adjusted mean difference|0.065|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.04|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666868|NCT01431287|3068307|Superiority or Other||Adjusted mean difference|0.018|Standard Error of the Mean|0.013|<|0.1747|2-Sided|95.0|-0.008|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666869|NCT01431287|3068307|Superiority or Other||Adjusted mean difference|0.041|Standard Error of the Mean|0.013|<|0.0014|2-Sided|95.0|0.016|0.067||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666870|NCT01431287|3068307|Superiority or Other||Adjusted mean difference|0.048|Standard Error of the Mean|0.013|<|0.0002|2-Sided|95.0|0.023|0.073||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666871|NCT01431287|3068307|Superiority or Other||Adjusted mean difference|0.082|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.057|0.107||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666872|NCT01431287|3068307|Superiority or Other||Adjusted mean difference|0.059|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.033|0.084||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666873|NCT01431287|3068307|Superiority or Other||Adjusted mean difference|0.1|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.074|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666874|NCT01431287|3068308|Superiority or Other||Adjusted mean difference|0.017|Standard Error of the Mean|0.013||0.1792|2-Sided|95.0|-0.008|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666875|NCT01431287|3068308|Superiority or Other||Adjusted mean difference|0.015|Standard Error of the Mean|0.013||0.2416|2-Sided|95.0|-0.01|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666876|NCT01431287|3068308|Superiority or Other||Adjusted mean difference|0.032|Standard Error of the Mean|0.013||0.0118|2-Sided|95.0|0.007|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666877|NCT01431287|3068308|Superiority or Other||Adjusted mean difference|0.065|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.039|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666878|NCT01431287|3068308|Superiority or Other||Adjusted mean difference|0.004|Standard Error of the Mean|0.013|<|0.7755|2-Sided|95.0|-0.022|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666879|NCT01431287|3068308|Superiority or Other||Adjusted mean difference|0.044|Standard Error of the Mean|0.013|<|0.0007|2-Sided|95.0|0.018|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666880|NCT01431287|3068308|Superiority or Other||Adjusted mean difference|0.061|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.036|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666881|NCT01431287|3068308|Superiority or Other||Adjusted mean difference|0.076|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.051|0.101||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666882|NCT01431287|3068308|Superiority or Other||Adjusted mean difference|0.047|Standard Error of the Mean|0.013|<|0.0002|2-Sided|95.0|0.022|0.073||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666883|NCT01431287|3068308|Superiority or Other||Adjusted mean difference|0.08|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.055|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666884|NCT01431287|3068309|Superiority or Other||Adjusted mean difference|0.027|Standard Error of the Mean|0.013||0.0351|2-Sided|95.0|0.002|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666885|NCT01431287|3068309|Superiority or Other||Adjusted mean difference|0.002|Standard Error of the Mean|0.013||0.8949|2-Sided|95.0|-0.023|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666886|NCT01431287|3068309|Superiority or Other||Adjusted mean difference|0.029|Standard Error of the Mean|0.013||0.025|2-Sided|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666887|NCT01431287|3068309|Superiority or Other||Adjusted mean difference|0.063|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.038|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666888|NCT01431287|3068309|Superiority or Other||Adjusted mean difference|0.001|Standard Error of the Mean|0.013|<|0.9633|2-Sided|95.0|-0.025|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666889|NCT01431287|3068309|Superiority or Other||Adjusted mean difference|0.036|Standard Error of the Mean|0.013|<|0.0057|2-Sided|95.0|0.01|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666890|NCT01431287|3068309|Superiority or Other||Adjusted mean difference|0.063|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.037|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666891|NCT01431287|3068309|Superiority or Other||Adjusted mean difference|0.064|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.039|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666892|NCT01431287|3068309|Superiority or Other||Adjusted mean difference|0.036|Standard Error of the Mean|0.013|<|0.005|2-Sided|95.0|0.011|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666893|NCT01431287|3068309|Superiority or Other||Adjusted mean difference|0.065|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.04|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666894|NCT01431287|3068310|Superiority or Other||Adjusted mean difference|0.02|Standard Error of the Mean|0.013||0.148|2-Sided|95.0|-0.007|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666895|NCT01431287|3068310|Superiority or Other||Adjusted mean difference|0.0|Standard Error of the Mean|0.014||0.9981|2-Sided|95.0|-0.026|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666896|NCT01431287|3068310|Superiority or Other||Adjusted mean difference|0.02|Standard Error of the Mean|0.014||0.1484|2-Sided|95.0|-0.007|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666897|NCT01431287|3068310|Superiority or Other||Adjusted mean difference|0.132|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.105|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666898|NCT01431287|3068310|Superiority or Other||Adjusted mean difference|0.014|Standard Error of the Mean|0.013|<|0.3008|2-Sided|95.0|-0.012|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666899|NCT01431287|3068310|Superiority or Other||Adjusted mean difference|0.098|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.072|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666900|NCT01431287|3068310|Superiority or Other||Adjusted mean difference|0.118|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.092|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666901|NCT01431287|3068310|Superiority or Other||Adjusted mean difference|0.118|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.092|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666902|NCT01431287|3068310|Superiority or Other||Adjusted mean difference|0.112|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.086|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666903|NCT01431287|3068310|Superiority or Other||Adjusted mean difference|0.132|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.105|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666904|NCT01431287|3068311|Superiority or Other||Adjusted mean difference|0.022|Standard Error of the Mean|0.013||0.0958|2-Sided|95.0|-0.004|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666905|NCT01431287|3068311|Superiority or Other||Adjusted mean difference|0.013|Standard Error of the Mean|0.013||0.3329|2-Sided|95.0|-0.013|0.038||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666906|NCT01431287|3068311|Superiority or Other||Adjusted mean difference|0.034|Standard Error of the Mean|0.013||0.0083|2-Sided|95.0|0.009|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666907|NCT01431287|3068311|Superiority or Other||Adjusted mean difference|0.132|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.107|0.158||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666908|NCT01431287|3068311|Superiority or Other||Adjusted mean difference|0.026|Standard Error of the Mean|0.013|<|0.047|2-Sided|95.0|0.0|0.051||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666909|NCT01431287|3068311|Superiority or Other||Adjusted mean difference|0.085|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.059|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666910|NCT01431287|3068311|Superiority or Other||Adjusted mean difference|0.106|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.081|0.132||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666911|NCT01431287|3068311|Superiority or Other||Adjusted mean difference|0.119|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.094|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666912|NCT01431287|3068311|Superiority or Other||Adjusted mean difference|0.111|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.085|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666913|NCT01431287|3068311|Superiority or Other||Adjusted mean difference|0.145|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.119|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666914|NCT01431287|3068312|Superiority or Other||Adjusted mean difference|0.029|Standard Error of the Mean|0.013||0.0243|2-Sided|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666915|NCT01431287|3068312|Superiority or Other||Adjusted mean difference|-0.061|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|-0.086|-0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666916|NCT01431287|3068312|Superiority or Other||Adjusted mean difference|-0.032|Standard Error of the Mean|0.013|<|0.0131|2-Sided|95.0|-0.057|-0.007||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666917|NCT01431287|3068312|Superiority or Other||Adjusted mean difference|0.094|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.069|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666918|NCT01431287|3068312|Superiority or Other||Adjusted mean difference|0.001|Standard Error of the Mean|0.013|<|0.9514|2-Sided|95.0|-0.024|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666919|NCT01431287|3068312|Superiority or Other||Adjusted mean difference|0.064|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.039|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666920|NCT01431287|3068312|Superiority or Other||Adjusted mean difference|0.093|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.068|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666921|NCT01431287|3068312|Superiority or Other||Adjusted mean difference|0.033|Standard Error of the Mean|0.013|<|0.0112|2-Sided|95.0|0.007|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666922|NCT01431287|3068312|Superiority or Other||Adjusted mean difference|0.065|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.04|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666923|NCT01431287|3068312|Superiority or Other||Adjusted mean difference|0.033|Standard Error of the Mean|0.013|<|0.0095|2-Sided|95.0|0.008|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666924|NCT01431287|3068313|Superiority or Other||Adjusted mean difference|-0.062|Standard Error of the Mean|0.135||0.6457|2-Sided|95.0|-0.327|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666925|NCT01431287|3068313|Superiority or Other||Adjusted mean difference|0.126|Standard Error of the Mean|0.135||0.3525|2-Sided|95.0|-0.14|0.391||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666926|NCT01431287|3068313|Superiority or Other||Adjusted mean difference|0.064|Standard Error of the Mean|0.136||0.6382|2-Sided|95.0|-0.202|0.33||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666927|NCT01431287|3068313|Superiority or Other||Adjusted mean difference|0.294|Standard Error of the Mean|0.134||0.0289|2-Sided|95.0|0.03|0.557||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666928|NCT01431287|3068313|Superiority or Other||Adjusted mean difference|0.003|Standard Error of the Mean|0.134||0.9801|2-Sided|95.0|-0.259|0.266||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666929|NCT01431287|3068313|Superiority or Other||Adjusted mean difference|0.352|Standard Error of the Mean|0.135||0.0088|2-Sided|95.0|0.089|0.616||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666930|NCT01431287|3068313|Superiority or Other||Adjusted mean difference|0.29|Standard Error of the Mean|0.134||0.0307|2-Sided|95.0|0.027|0.554||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666931|NCT01431287|3068313|Superiority or Other||Adjusted mean difference|0.416|Standard Error of the Mean|0.135||0.002|2-Sided|95.0|0.152|0.681||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666932|NCT01431287|3068313|Superiority or Other||Adjusted mean difference|0.356|Standard Error of the Mean|0.135||0.0082|2-Sided|95.0|0.092|0.619||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666933|NCT01431287|3068313|Superiority or Other||Adjusted mean difference|0.42|Standard Error of the Mean|0.135||0.0019|2-Sided|95.0|0.155|0.684||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|Spatial power covariance structure for within−patient errors.||
1666934|NCT01431287|3068314|Superiority or Other||Adjusted mean difference|0.115|Standard Error of the Mean|0.554||0.8355|2-Sided|95.0|-0.97|1.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666935|NCT01431287|3068314|Superiority or Other||Adjusted mean difference|-0.575|Standard Error of the Mean|0.556||0.3013|2-Sided|95.0|-1.664|0.515||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666936|NCT01431287|3068314|Superiority or Other||Adjusted mean difference|-0.46|Standard Error of the Mean|0.557||0.4097|2-Sided|95.0|-1.552|0.633||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666937|NCT01431287|3068314|Superiority or Other||Adjusted mean difference|-1.118|Standard Error of the Mean|0.549||0.0418|2-Sided|95.0|-2.195|-0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666938|NCT01431287|3068314|Superiority or Other||Adjusted mean difference|-0.662|Standard Error of the Mean|0.545||0.2249|2-Sided|95.0|-1.731|0.407||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666939|NCT01431287|3068314|Superiority or Other||Adjusted mean difference|-0.571|Standard Error of the Mean|0.55||0.2988|2-Sided|95.0|-1.649|0.507||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666940|NCT01431287|3068314|Superiority or Other||Adjusted mean difference|-0.456|Standard Error of the Mean|0.548||0.4051|2-Sided|95.0|-1.531|0.618||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666941|NCT01431287|3068314|Superiority or Other||Adjusted mean difference|-1.031|Standard Error of the Mean|0.552||0.062|2-Sided|95.0|-2.113|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666942|NCT01431287|3068314|Superiority or Other||Adjusted mean difference|-1.233|Standard Error of the Mean|0.551||0.0252|2-Sided|95.0|-2.313|-0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666943|NCT01431287|3068314|Superiority or Other||Adjusted mean difference|-1.693|Standard Error of the Mean|0.553||0.0022|2-Sided|95.0|-2.778|-0.608||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666944|NCT01431287|3068315|Superiority or Other||Adjusted mean difference|0.033|Standard Error of the Mean|0.013||0.0097|2-Sided|95.0|0.008|0.058||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666945|NCT01431287|3068315|Superiority or Other||Adjusted mean difference|0.005|Standard Error of the Mean|0.013||0.6939|2-Sided|95.0|-0.02|0.03||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666946|NCT01431287|3068315|Superiority or Other||Adjusted mean difference|0.038|Standard Error of the Mean|0.013||0.0029|2-Sided|95.0|0.013|0.063||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666947|NCT01431287|3068315|Superiority or Other||Adjusted mean difference|0.083|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.058|0.108||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666948|NCT01431287|3068315|Superiority or Other||Adjusted mean difference|0.021|Standard Error of the Mean|0.013|<|0.1073|2-Sided|95.0|-0.004|0.046||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666949|NCT01431287|3068315|Superiority or Other||Adjusted mean difference|0.029|Standard Error of the Mean|0.013|<|0.0231|2-Sided|95.0|0.004|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666950|NCT01431287|3068315|Superiority or Other||Adjusted mean difference|0.062|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.037|0.087||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666951|NCT01431287|3068315|Superiority or Other||Adjusted mean difference|0.067|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.042|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666952|NCT01431287|3068315|Superiority or Other||Adjusted mean difference|0.05|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.024|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666953|NCT01431287|3068315|Superiority or Other||Adjusted mean difference|0.088|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.063|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666954|NCT01431287|3068316|Superiority or Other||Adjusted mean difference|0.04|Standard Error of the Mean|0.012||0.0014|2-Sided|95.0|0.015|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666955|NCT01431287|3068316|Superiority or Other||Adjusted mean difference|-0.01|Standard Error of the Mean|0.013||0.421|2-Sided|95.0|-0.035|0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666956|NCT01431287|3068316|Superiority or Other||Adjusted mean difference|0.03|Standard Error of the Mean|0.012||0.0173|2-Sided|95.0|0.005|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666957|NCT01431287|3068316|Superiority or Other||Adjusted mean difference|0.143|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.118|0.167||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666958|NCT01431287|3068316|Superiority or Other||Adjusted mean difference|0.012|Standard Error of the Mean|0.012|<|0.3394|2-Sided|95.0|-0.013|0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666959|NCT01431287|3068316|Superiority or Other||Adjusted mean difference|0.091|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.066|0.115||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666960|NCT01431287|3068316|Superiority or Other||Adjusted mean difference|0.131|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.106|0.155||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666961|NCT01431287|3068316|Superiority or Other||Adjusted mean difference|0.121|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.096|0.145||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666962|NCT01431287|3068316|Superiority or Other||Adjusted mean difference|0.103|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.078|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666963|NCT01431287|3068316|Superiority or Other||Adjusted mean difference|0.132|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.108|0.157||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|spatial power covariance structure for within-patient errors||
1666964|NCT01431274|3068317|Superiority or Other||Adjusted mean difference|0.286|Standard Error of the Mean|0.142||0.0442|2-Sided|95.0|0.007|0.564||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1666965|NCT01431274|3068317|Superiority or Other||Adjusted mean difference|0.039|Standard Error of the Mean|0.142||0.7855|2-Sided|95.0|-0.24|0.317||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1666966|NCT01431274|3068317|Superiority or Other||Adjusted mean difference|0.325|Standard Error of the Mean|0.143||0.023|2-Sided|95.0|0.045|0.605||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg)~Spatial power covariance structure for within−patient errors."||
1666967|NCT01431274|3068317|Superiority or Other||Adjusted mean difference|0.608|Standard Error of the Mean|0.141|<|0.0001|2-Sided|95.0|0.332|0.884||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1666968|NCT01431274|3068317|Superiority or Other||Adjusted mean difference|0.276|Standard Error of the Mean|0.14|<|0.0492|2-Sided|95.0|0.001|0.551||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 μg).~Spatial power covariance structure for within−patient errors."||
1666969|NCT01431274|3068317|Superiority or Other||Adjusted mean difference|0.046|Standard Error of the Mean|0.142|<|0.7441|2-Sided|95.0|-0.231|0.324||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1666970|NCT01431274|3068317|Superiority or Other||Adjusted mean difference|0.332|Standard Error of the Mean|0.141|<|0.0186|2-Sided|95.0|0.056|0.609||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1666971|NCT01431274|3068317|Superiority or Other||Adjusted mean difference|0.371|Standard Error of the Mean|0.142|<|0.0089|2-Sided|95.0|0.093|0.649||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1666972|NCT01431274|3068317|Superiority or Other||Adjusted mean difference|0.322|Standard Error of the Mean|0.141|<|0.0226|2-Sided|95.0|0.045|0.6||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1666973|NCT01431274|3068317|Superiority or Other||Adjusted mean difference|0.647|Standard Error of the Mean|0.142|<|0.0001|2-Sided|95.0|0.37|0.925||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1666974|NCT01431274|3068318|Superiority or Other||Adjusted mean difference|0.004|Standard Error of the Mean|0.138||0.9765|2-Sided|95.0|-0.265|0.274||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1666975|NCT01431274|3068318|Superiority or Other||Adjusted mean difference|0.192|Standard Error of the Mean|0.137||0.1626|2-Sided|95.0|-0.077|0.461||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1666976|NCT01431274|3068318|Superiority or Other||Adjusted mean difference|0.196|Standard Error of the Mean|0.137||0.1542|2-Sided|95.0|-0.074|0.465||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1666977|NCT01431274|3068318|Superiority or Other||Adjusted mean difference|0.438|Standard Error of the Mean|0.137||0.0014|2-Sided|95.0|0.17|0.707||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1666978|NCT01431274|3068318|Superiority or Other||Adjusted mean difference|0.211|Standard Error of the Mean|0.136||0.122|2-Sided|95.0|-0.056|0.478||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1666979|NCT01431274|3068318|Superiority or Other||Adjusted mean difference|0.223|Standard Error of the Mean|0.137||0.1029|2-Sided|95.0|-0.045|0.492||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1666980|NCT01431274|3068318|Superiority or Other||Adjusted mean difference|0.227|Standard Error of the Mean|0.137||0.0966|2-Sided|95.0|-0.041|0.495||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1666981|NCT01431274|3068318|Superiority or Other||Adjusted mean difference|0.419|Standard Error of the Mean|0.137||0.0022|2-Sided|95.0|0.151|0.687||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1666982|NCT01431274|3068318|Superiority or Other||Adjusted mean difference|0.434|Standard Error of the Mean|0.137||0.0015|2-Sided|95.0|0.166|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1666983|NCT01431274|3068318|Superiority or Other||Adjusted mean difference|0.63|Standard Error of the Mean|0.137|<|0.0001|2-Sided|95.0|0.362|0.898||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1666984|NCT01431274|3068319|Superiority or Other||Adjusted mean difference|-0.022|Standard Error of the Mean|0.137||0.8709|2-Sided|95.0|-0.29|0.246||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1666985|NCT01431274|3068319|Superiority or Other||Adjusted mean difference|-0.023|Standard Error of the Mean|0.136||0.8687|2-Sided|95.0|-0.29|0.245||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1666986|NCT01431274|3068319|Superiority or Other||Adjusted mean difference|-0.045|Standard Error of the Mean|0.137||0.7432|2-Sided|95.0|-0.313|0.223||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1666987|NCT01431274|3068319|Superiority or Other||Adjusted mean difference|0.618|Standard Error of the Mean|0.136|<|0.0001|2-Sided|95.0|0.351|0.885||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667016|NCT01431274|3068322|Superiority or Other||Adjusted mean difference|0.012|Standard Error of the Mean|0.041||0.7784|2-Sided|95.0|-0.069|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).||
1667706|NCT01421459|3069385|Superiority or Other|||||||0.831||||||P-value is for Lifestyle Flexibility at Endpoint, up to 24 weeks.|ANCOVA||||
1666988|NCT01431274|3068319|Superiority or Other||Adjusted mean difference|0.172|Standard Error of the Mean|0.136|<|0.2045|2-Sided|95.0|-0.094|0.438||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1666989|NCT01431274|3068319|Superiority or Other||Adjusted mean difference|0.468|Standard Error of the Mean|0.136|<|0.0006|2-Sided|95.0|0.201|0.735||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1666990|NCT01431274|3068319|Superiority or Other||Adjusted mean difference|0.446|Standard Error of the Mean|0.136|<|0.0011|2-Sided|95.0|0.179|0.712||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1666991|NCT01431274|3068319|Superiority or Other||Adjusted mean difference|0.423|Standard Error of the Mean|0.136|<|0.0019|2-Sided|95.0|0.156|0.69||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1666992|NCT01431274|3068319|Superiority or Other||Adjusted mean difference|0.64|Standard Error of the Mean|0.136|<|0.0001|2-Sided|95.0|0.373|0.907||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1666993|NCT01431274|3068319|Superiority or Other||Adjusted mean difference|0.595|Standard Error of the Mean|0.136|<|0.0001|2-Sided|95.0|0.329|0.862||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1666994|NCT01431274|3068320|Superiority or Other||Adjusted mean difference|-0.027|Standard Error of the Mean|0.58||0.9624|2-Sided|95.0|-1.164|1.109||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1666995|NCT01431274|3068320|Superiority or Other||Adjusted mean difference|-1.381|Standard Error of the Mean|0.582||0.0177|2-Sided|95.0|-2.521|-0.24||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1666996|NCT01431274|3068320|Superiority or Other||Adjusted mean difference|-1.408|Standard Error of the Mean|0.583||0.0158|2-Sided|95.0|-2.551|-0.265||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1666997|NCT01431274|3068320|Superiority or Other||Adjusted mean difference|-0.471|Standard Error of the Mean|0.575||0.4126|2-Sided|95.0|-1.598|0.656||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1666998|NCT01431274|3068320|Superiority or Other||Adjusted mean difference|-0.415|Standard Error of the Mean|0.57||0.4669|2-Sided|95.0|-1.533|0.703||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1666999|NCT01431274|3068320|Superiority or Other||Adjusted mean difference|-0.029|Standard Error of the Mean|0.576||0.9602|2-Sided|95.0|-1.157|1.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|ANCOVA|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667000|NCT01431274|3068320|Superiority or Other||Adjusted mean difference|-0.056|Standard Error of the Mean|0.574||0.9222|2-Sided|95.0|-1.182|1.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667017|NCT01431274|3068322|Superiority or Other||Adjusted mean difference|0.188|Standard Error of the Mean|0.041|<|0.0001|2-Sided|95.0|0.108|0.269||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).||
1668913|NCT01400932|3071291|Superiority or Other||||||<|0.008||||||Week 2; NIL|ANCOVA||||
1667001|NCT01431274|3068320|Superiority or Other||Adjusted mean difference|-1.437|Standard Error of the Mean|0.578||0.0129|2-Sided|95.0|-2.569|-0.304||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667002|NCT01431274|3068320|Superiority or Other||Adjusted mean difference|-0.444|Standard Error of the Mean|0.576||0.4413|2-Sided|95.0|-1.573|0.686||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667003|NCT01431274|3068320|Superiority or Other||Adjusted mean difference|-1.852|Standard Error of the Mean|0.578||0.0014|2-Sided|95.0|-2.985|-0.718||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667004|NCT01431274|3068321|Superiority or Other||Adjusted mean difference|0.001|Standard Error of the Mean|0.563||0.9983|2-Sided|95.0|-1.102|1.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667005|NCT01431274|3068321|Superiority or Other||Adjusted mean difference|-1.011|Standard Error of the Mean|0.563||0.0724|2-Sided|95.0|-2.114|0.092||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667006|NCT01431274|3068321|Superiority or Other||Adjusted mean difference|-1.01|Standard Error of the Mean|0.563||0.0732|2-Sided|95.0|-2.114|0.095||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667007|NCT01431274|3068321|Superiority or Other||Adjusted mean difference|-1.13|Standard Error of the Mean|0.559||0.0434|2-Sided|95.0|-2.227|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667008|NCT01431274|3068321|Superiority or Other||Adjusted mean difference|-0.613|Standard Error of the Mean|0.556||0.2697|2-Sided|95.0|-1.702|0.476||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667009|NCT01431274|3068321|Superiority or Other||Adjusted mean difference|-0.518|Standard Error of the Mean|0.559||0.3542|2-Sided|95.0|-1.614|0.578||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667010|NCT01431274|3068321|Superiority or Other||Adjusted mean difference|-0.517|Standard Error of the Mean|0.558||0.3545|2-Sided|95.0|-1.611|0.577||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667011|NCT01431274|3068321|Superiority or Other||Adjusted mean difference|-1.528|Standard Error of the Mean|0.559||0.0063|2-Sided|95.0|-2.623|-0.432||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667012|NCT01431274|3068321|Superiority or Other||Adjusted mean difference|-1.131|Standard Error of the Mean|0.56||0.0435|2-Sided|95.0|-2.23|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).||
1667013|NCT01431274|3068321|Superiority or Other||Adjusted mean difference|-2.141|Standard Error of the Mean|0.56||0.0001|2-Sided|95.0|-3.239|-1.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667014|NCT01431274|3068322|Superiority or Other||Adjusted mean difference|0.063|Standard Error of the Mean|0.041||0.1315|2-Sided|95.0|-0.019|0.144||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).||
1667018|NCT01431274|3068322|Superiority or Other||Adjusted mean difference|0.032|Standard Error of the Mean|0.041|<|0.4393|2-Sided|95.0|-0.049|0.113||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).||
1667019|NCT01431274|3068322|Superiority or Other||Adjusted mean difference|0.094|Standard Error of the Mean|0.042|<|0.0255|2-Sided|95.0|0.011|0.176||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).||
1667020|NCT01431274|3068322|Superiority or Other||Adjusted mean difference|0.156|Standard Error of the Mean|0.04|<|0.0001|2-Sided|95.0|0.077|0.235||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).||
1667021|NCT01431274|3068322|Superiority or Other||Adjusted mean difference|0.105|Standard Error of the Mean|0.04|<|0.0085|2-Sided|95.0|0.027|0.183||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).||
1667022|NCT01431274|3068322|Superiority or Other||Adjusted mean difference|0.126|Standard Error of the Mean|0.043|<|0.0032|2-Sided|95.0|0.042|0.209||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).||
1667023|NCT01431274|3068322|Superiority or Other||Adjusted mean difference|0.137|Standard Error of the Mean|0.041|<|0.0008|2-Sided|95.0|0.057|0.217||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).||
1667024|NCT01431274|3068323|Superiority or Other||Adjusted mean difference|0.068|Standard Error of the Mean|0.043||0.1188|2-Sided|95.0|-0.017|0.153||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).||
1667025|NCT01431274|3068323|Superiority or Other||Adjusted mean difference|-0.047|Standard Error of the Mean|0.041||0.253|2-Sided|95.0|-0.129|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).||
1667026|NCT01431274|3068323|Superiority or Other||Adjusted mean difference|0.021|Standard Error of the Mean|0.043||0.6335|2-Sided|95.0|-0.064|0.105||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).||
1667027|NCT01431274|3068323|Superiority or Other||Adjusted mean difference|0.208|Standard Error of the Mean|0.043|<|0.0001|2-Sided|95.0|0.124|0.293||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).||
1667028|NCT01431274|3068323|Superiority or Other||Adjusted mean difference|0.032|Standard Error of the Mean|0.043|<|0.4581|2-Sided|95.0|-0.053|0.118||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).||
1667029|NCT01431274|3068323|Superiority or Other||Adjusted mean difference|0.108|Standard Error of the Mean|0.044|<|0.0141|2-Sided|95.0|0.022|0.194||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).||
1667030|NCT01431274|3068323|Superiority or Other||Adjusted mean difference|0.176|Standard Error of the Mean|0.042|<|0.0001|2-Sided|95.0|0.093|0.259||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).||
1667031|NCT01431274|3068323|Superiority or Other||Adjusted mean difference|0.128|Standard Error of the Mean|0.042|<|0.0022|2-Sided|95.0|0.046|0.21||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).||
1667032|NCT01431274|3068323|Superiority or Other||Adjusted mean difference|0.14|Standard Error of the Mean|0.045|<|0.0017|2-Sided|95.0|0.053|0.228||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).||
1667033|NCT01431274|3068323|Superiority or Other||Adjusted mean difference|0.161|Standard Error of the Mean|0.043|<|0.0002|2-Sided|95.0|0.077|0.244||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).||
1667034|NCT01431274|3068324|Superiority or Other||Adjusted mean difference|0.017|Standard Error of the Mean|0.021||0.4374|2-Sided|95.0|-0.025|0.059||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).||
1667035|NCT01431274|3068324|Superiority or Other||Adjusted mean difference|-0.024|Standard Error of the Mean|0.02||0.2332|2-Sided|95.0|-0.065|0.016||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).||
1667036|NCT01431274|3068324|Superiority or Other||Adjusted mean difference|-0.008|Standard Error of the Mean|0.021||0.7116|2-Sided|95.0|-0.049|0.034||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).||
1667037|NCT01431274|3068324|Superiority or Other||Adjusted mean difference|0.122|Standard Error of the Mean|0.021|<|0.0001|2-Sided|95.0|0.081|0.164||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).||
1667038|NCT01431274|3068324|Superiority or Other||Adjusted mean difference|0.047|Standard Error of the Mean|0.021|<|0.0277|2-Sided|95.0|0.005|0.089||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).||
1667039|NCT01431274|3068324|Superiority or Other||Adjusted mean difference|0.059|Standard Error of the Mean|0.022|<|0.0065|2-Sided|95.0|0.016|0.101||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).||
1667040|NCT01431274|3068324|Superiority or Other||Adjusted mean difference|0.075|Standard Error of the Mean|0.021|<|0.0003|2-Sided|95.0|0.035|0.116||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).||
1667041|NCT01431274|3068324|Superiority or Other||Adjusted mean difference|0.051|Standard Error of the Mean|0.021|<|0.0136|2-Sided|95.0|0.01|0.091||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).||
1667042|NCT01431274|3068324|Superiority or Other||Adjusted mean difference|0.106|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.063|0.149||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).||
1667043|NCT01431274|3068324|Superiority or Other||Adjusted mean difference|0.098|Standard Error of the Mean|0.021|<|0.0001|2-Sided|95.0|0.057|0.139||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).||
1667044|NCT01431274|3068325|Superiority or Other||Adjusted mean difference|0.018|Standard Error of the Mean|0.023||0.4311|2-Sided|95.0|-0.027|0.063||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Tiotropium (2.5 µg).||
1667045|NCT01431274|3068325|Superiority or Other||Adjusted mean difference|-0.022|Standard Error of the Mean|0.022||0.3048|2-Sided|95.0|-0.065|0.02||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (2.5 µg) versus Olodaterol (5 µg).||
1667046|NCT01431274|3068325|Superiority or Other||Adjusted mean difference|-0.004|Standard Error of the Mean|0.023||0.8428|2-Sided|95.0|-0.049|0.04||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tiotropium (5 µg) versus Olodaterol (5 µg).||
1667047|NCT01431274|3068325|Superiority or Other||Adjusted mean difference|0.141|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.097|0.185||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).||
1667048|NCT01431274|3068325|Superiority or Other||Adjusted mean difference|0.047|Standard Error of the Mean|0.023|<|0.0384|2-Sided|95.0|0.003|0.092||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).||
1667049|NCT01431274|3068325|Superiority or Other||Adjusted mean difference|0.076|Standard Error of the Mean|0.023|<|0.001|2-Sided|95.0|0.031|0.121||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).||
1667050|NCT01431274|3068325|Superiority or Other||Adjusted mean difference|0.094|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.05|0.137||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).||
1667051|NCT01431274|3068325|Superiority or Other||Adjusted mean difference|0.071|Standard Error of the Mean|0.022|<|0.0012|2-Sided|95.0|0.028|0.114||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).||
1667052|NCT01431274|3068325|Superiority or Other||Adjusted mean difference|0.123|Standard Error of the Mean|0.023|<|0.0001|2-Sided|95.0|0.077|0.169||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).||
1667053|NCT01431274|3068325|Superiority or Other||Adjusted mean difference|0.118|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.074|0.162||ANCOVA model with categorical effect of treatment and baseline as covariate.|ANCOVA||Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).||
1667054|NCT01431274|3068326|Superiority or Other||Adjusted mean difference|-0.007|Standard Error of the Mean|0.026||0.7925|2-Sided|95.0|-0.057|0.044||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667055|NCT01431274|3068326|Superiority or Other||Adjusted mean difference|0.101|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.05|0.151||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667056|NCT01431274|3068326|Superiority or Other||Adjusted mean difference|0.094|Standard Error of the Mean|0.026|<|0.0003|2-Sided|95.0|0.044|0.144||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667057|NCT01431274|3068326|Superiority or Other||Adjusted mean difference|0.077|Standard Error of the Mean|0.026|<|0.0027|2-Sided|95.0|0.027|0.127||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667058|NCT01431274|3068326|Superiority or Other||Adjusted mean difference|0.036|Standard Error of the Mean|0.026|<|0.1615|2-Sided|95.0|-0.014|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667059|NCT01431274|3068326|Superiority or Other||Adjusted mean difference|0.048|Standard Error of the Mean|0.026|<|0.0632|2-Sided|95.0|-0.003|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667060|NCT01431274|3068326|Superiority or Other||Adjusted mean difference|0.041|Standard Error of the Mean|0.026|<|0.1112|2-Sided|95.0|-0.009|0.091||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667061|NCT01431274|3068326|Superiority or Other||Adjusted mean difference|0.142|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.091|0.192||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667275|NCT01430624|3068383|Superiority or Other|||||||0.35||||||6 month comparison|ANOVA|df = 2,116|||
1667276|NCT01430624|3068383|Superiority or Other|||||||0.31||||||3 month comparison|ANOVA|df = 2, 132|||
1667062|NCT01431274|3068326|Superiority or Other||Adjusted mean difference|0.084|Standard Error of the Mean|0.026|<|0.0011|2-Sided|95.0|0.033|0.134||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667063|NCT01431274|3068326|Superiority or Other||Adjusted mean difference|0.178|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.127|0.228||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667064|NCT01431274|3068327|Superiority or Other||Adjusted mean difference|-0.014|Standard Error of the Mean|0.024||0.5554|2-Sided|95.0|-0.062|0.034||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667065|NCT01431274|3068327|Superiority or Other||Adjusted mean difference|0.091|Standard Error of the Mean|0.025||0.0002|2-Sided|95.0|0.043|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667066|NCT01431274|3068327|Superiority or Other||Adjusted mean difference|0.076|Standard Error of the Mean|0.025||0.0018|2-Sided|95.0|0.028|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667067|NCT01431274|3068327|Superiority or Other||Adjusted mean difference|0.062|Standard Error of the Mean|0.024||0.0105|2-Sided|95.0|0.015|0.11||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667068|NCT01431274|3068327|Superiority or Other||Adjusted mean difference|0.021|Standard Error of the Mean|0.024||0.3802|2-Sided|95.0|-0.026|0.069||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667069|NCT01431274|3068327|Superiority or Other||Adjusted mean difference|0.055|Standard Error of the Mean|0.024||0.0231|2-Sided|95.0|0.008|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667070|NCT01431274|3068327|Superiority or Other||Adjusted mean difference|0.041|Standard Error of the Mean|0.024||0.0926|2-Sided|95.0|-0.007|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667071|NCT01431274|3068327|Superiority or Other||Adjusted mean difference|0.132|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.084|0.18||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667072|NCT01431274|3068327|Superiority or Other||Adjusted mean difference|0.077|Standard Error of the Mean|0.024|<|0.0016|2-Sided|95.0|0.029|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667073|NCT01431274|3068327|Superiority or Other||Adjusted mean difference|0.153|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.105|0.201||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667074|NCT01431274|3068328|Superiority or Other||Adjusted mean difference|-0.024|Standard Error of the Mean|0.025||0.3332|2-Sided|95.0|-0.074|0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667277|NCT01430624|3068383|Superiority or Other|||||||0.012||||||6 week comparison|ANOVA|df = 2, 151|||
1667278|NCT01430624|3068384|Superiority or Other|||||||0.13||||||6 month comparison|ANOVA|df = 2, 118|||
1667279|NCT01430624|3068384|Superiority or Other|||||||0.29||||||3 month comparison|ANOVA|df = 2, 132|||
1667075|NCT01431274|3068328|Superiority or Other||Adjusted mean difference|0.09|Standard Error of the Mean|0.025||0.0003|2-Sided|95.0|0.041|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667076|NCT01431274|3068328|Superiority or Other||Adjusted mean difference|0.066|Standard Error of the Mean|0.025||0.0085|2-Sided|95.0|0.017|0.115||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667077|NCT01431274|3068328|Superiority or Other||Adjusted mean difference|0.097|Standard Error of the Mean|0.025||0.0001|2-Sided|95.0|0.048|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667078|NCT01431274|3068328|Superiority or Other||Adjusted mean difference|0.035|Standard Error of the Mean|0.025||0.167|2-Sided|95.0|-0.015|0.084||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667079|NCT01431274|3068328|Superiority or Other||Adjusted mean difference|0.086|Standard Error of the Mean|0.025||0.0006|2-Sided|95.0|0.037|0.136||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667080|NCT01431274|3068328|Superiority or Other||Adjusted mean difference|0.062|Standard Error of the Mean|0.025||0.0134|2-Sided|95.0|0.013|0.111||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667081|NCT01431274|3068328|Superiority or Other||Adjusted mean difference|0.153|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.103|0.202||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667082|NCT01431274|3068328|Superiority or Other||Adjusted mean difference|0.121|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.072|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667083|NCT01431274|3068328|Superiority or Other||Adjusted mean difference|0.187|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.138|0.237||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667084|NCT01431274|3068329|Superiority or Other||Adjusted mean difference|0.007|Standard Error of the Mean|0.025||0.7889|2-Sided|95.0|-0.042|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667085|NCT01431274|3068329|Superiority or Other||Adjusted mean difference|0.056|Standard Error of the Mean|0.025||0.025|2-Sided|95.0|0.007|0.105||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667086|NCT01431274|3068329|Superiority or Other||Adjusted mean difference|0.063|Standard Error of the Mean|0.025||0.012|2-Sided|95.0|0.014|0.112||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667087|NCT01431274|3068329|Superiority or Other||Adjusted mean difference|0.112|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.063|0.161||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667280|NCT01430624|3068384|Superiority or Other|||||||0.83||||||6 week comparison|ANOVA|df = 2, 151|||
1667281|NCT01430624|3068385|Superiority or Other|||||||0.59||||||6 month comparison|ANOVA|df = 2, 118|||
1667282|NCT01430624|3068385|Superiority or Other|||||||0.25||||||3 month comparison|ANOVA|df = 2, 132|||
1667088|NCT01431274|3068329|Superiority or Other||Adjusted mean difference|0.065|Standard Error of the Mean|0.025|<|0.0097|2-Sided|95.0|0.016|0.114||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667089|NCT01431274|3068329|Superiority or Other||Adjusted mean difference|0.041|Standard Error of the Mean|0.025|<|0.1042|2-Sided|95.0|-0.008|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667090|NCT01431274|3068329|Superiority or Other||Adjusted mean difference|0.047|Standard Error of the Mean|0.025|<|0.0585|2-Sided|95.0|-0.002|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667091|NCT01431274|3068329|Superiority or Other||Adjusted mean difference|0.103|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.054|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667092|NCT01431274|3068329|Superiority or Other||Adjusted mean difference|0.105|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.056|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667093|NCT01431274|3068329|Superiority or Other||Adjusted mean difference|0.168|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.119|0.217||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667094|NCT01431274|3068330|Superiority or Other||Adjusted mean difference|-0.002|Standard Error of the Mean|0.025||0.9369|2-Sided|95.0|-0.051|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667095|NCT01431274|3068330|Superiority or Other||Adjusted mean difference|0.073|Standard Error of the Mean|0.025||0.0035|2-Sided|95.0|0.024|0.122||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667096|NCT01431274|3068330|Superiority or Other||Adjusted mean difference|0.071|Standard Error of the Mean|0.025||0.0045|2-Sided|95.0|0.022|0.12||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667097|NCT01431274|3068330|Superiority or Other||Adjusted mean difference|0.074|Standard Error of the Mean|0.025||0.0029|2-Sided|95.0|0.025|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667098|NCT01431274|3068330|Superiority or Other||Adjusted mean difference|0.026|Standard Error of the Mean|0.025||0.2949|2-Sided|95.0|-0.023|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667099|NCT01431274|3068330|Superiority or Other||Adjusted mean difference|0.05|Standard Error of the Mean|0.025||0.0456|2-Sided|95.0|0.001|0.099||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667100|NCT01431274|3068330|Superiority or Other||Adjusted mean difference|0.048|Standard Error of the Mean|0.025||0.0545|2-Sided|95.0|-0.001|0.097||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 μg).~Spatial power covariance structure for within−patient errors."||
1667283|NCT01430624|3068385|Superiority or Other|||||||0.63||||||6 week comparison|ANOVA|df = 2, 150|||
1667284|NCT01430624|3068386|Superiority or Other|||||||0.87||||||6 month comparison|Chi-squared|df = 2, 121|||
1667285|NCT01430624|3068386|Superiority or Other|||||||0.15||||||3 month comparison|Chi-squared|df = 2, 135|||
1667101|NCT01431274|3068330|Superiority or Other||Adjusted mean difference|0.121|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.072|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667102|NCT01431274|3068330|Superiority or Other||Adjusted mean difference|0.076|Standard Error of the Mean|0.025|<|0.0023|2-Sided|95.0|0.027|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667103|NCT01431274|3068330|Superiority or Other||Adjusted mean difference|0.147|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.098|0.196||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667104|NCT01431274|3068331|Superiority or Other||Adjusted mean difference|-0.02|Standard Deviation|0.025||0.4368|2-Sided|95.0|-0.07|0.03||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667105|NCT01431274|3068331|Superiority or Other||Adjusted mean difference|0.068|Standard Error of the Mean|0.025||0.0073|2-Sided|95.0|0.018|0.118||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667106|NCT01431274|3068331|Superiority or Other||Adjusted mean difference|0.049|Standard Error of the Mean|0.025||0.0559|2-Sided|95.0|-0.001|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667107|NCT01431274|3068331|Superiority or Other||Adjusted mean difference|0.137|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.087|0.186||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667108|NCT01431274|3068331|Superiority or Other||Adjusted mean difference|0.013|Standard Error of the Mean|0.025|<|0.6103|2-Sided|95.0|-0.037|0.062||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667109|NCT01431274|3068331|Superiority or Other||Adjusted mean difference|0.144|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.094|0.193||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667110|NCT01431274|3068331|Superiority or Other||Adjusted mean difference|0.124|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.074|0.174||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667111|NCT01431274|3068331|Superiority or Other||Adjusted mean difference|0.192|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.142|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667112|NCT01431274|3068331|Superiority or Other||Adjusted mean difference|0.156|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.107|0.206||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667113|NCT01431274|3068331|Superiority or Other||Adjusted mean difference|0.205|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.155|0.255||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667286|NCT01430624|3068386|Superiority or Other|||||||0.37||||||6 week comparison|Chi-squared|df = 2, 154|||
1667287|NCT01430624|3068387|Superiority or Other|||||||0.17||||||6 month comparison|ANOVA||||
1667288|NCT01430624|3068387|Superiority or Other|||||||0.48||||||3 month comparison|ANOVA||||
1667114|NCT01431274|3068332|Superiority or Other||Adjusted mean difference|-0.025|Standard Error of the Mean|0.024||0.2945|2-Sided|95.0|-0.071|0.022||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667115|NCT01431274|3068332|Superiority or Other||Adjusted mean difference|0.067|Standard Error of the Mean|0.024||0.0047|2-Sided|95.0|0.021|0.114||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667116|NCT01431274|3068332|Superiority or Other||Adjusted mean difference|0.042|Standard Error of the Mean|0.024||0.0744|2-Sided|95.0|-0.004|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667117|NCT01431274|3068332|Superiority or Other||Adjusted mean difference|0.128|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.082|0.175||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667118|NCT01431274|3068332|Superiority or Other||Adjusted mean difference|0.021|Standard Error of the Mean|0.024|<|0.3727|2-Sided|95.0|-0.025|0.067||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667119|NCT01431274|3068332|Superiority or Other||Adjusted mean difference|0.132|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.086|0.178||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667120|NCT01431274|3068332|Superiority or Other||Adjusted mean difference|0.107|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.061|0.154||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667121|NCT01431274|3068332|Superiority or Other||Adjusted mean difference|0.174|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.128|0.221||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667122|NCT01431274|3068332|Superiority or Other||Adjusted mean difference|0.153|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.107|0.199||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667123|NCT01431274|3068332|Superiority or Other||Adjusted mean difference|0.195|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.149|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667124|NCT01431274|3068333|Superiority or Other||Adjusted mean difference|-0.043|Standard Error of the Mean|0.025||0.0815|2-Sided|95.0|-0.091|0.005||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667125|NCT01431274|3068333|Superiority or Other||Adjusted mean difference|0.071|Standard Error of the Mean|0.025||0.0041|2-Sided|95.0|0.022|0.119||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667126|NCT01431274|3068333|Superiority or Other||Adjusted mean difference|0.028|Standard Error of the Mean|0.025||0.2562|2-Sided|95.0|-0.02|0.076||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667289|NCT01430624|3068387|Superiority or Other|||||||0.01||||||6 week comparison|ANOVA|df = 2, 150|||
1667290|NCT01430624|3068388|Superiority or Other|||||||0.89||||||6 month follow-up comparison|ANOVA|df = 2, 111|||
1667291|NCT01430624|3068389|Superiority or Other|||||||0.24||||||6 month follow-up comparison|ANOVA|df 2, 109|||
1667127|NCT01431274|3068333|Superiority or Other||Adjusted mean difference|0.151|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.102|0.199||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667128|NCT01431274|3068333|Superiority or Other||Adjusted mean difference|0.037|Standard Error of the Mean|0.025|<|0.1355|2-Sided|95.0|-0.012|0.085||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667129|NCT01431274|3068333|Superiority or Other||Adjusted mean difference|0.157|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.108|0.205||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667130|NCT01431274|3068333|Superiority or Other||Adjusted mean difference|0.114|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.065|0.162||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667131|NCT01431274|3068333|Superiority or Other||Adjusted mean difference|0.185|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.136|0.233||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667132|NCT01431274|3068333|Superiority or Other||Adjusted mean difference|0.193|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.145|0.242||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667133|NCT01431274|3068333|Superiority or Other||Adjusted mean difference|0.221|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.173|0.27||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667134|NCT01431274|3068334|Superiority or Other||Adjusted mean difference|0.011|Standard Error of the Mean|0.024||0.6408|2-Sided|95.0|-0.036|0.059||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667135|NCT01431274|3068334|Superiority or Other||Adjusted mean difference|-0.073|Standard Error of the Mean|0.024||0.0029|2-Sided|95.0|-0.121|-0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667136|NCT01431274|3068334|Superiority or Other||Adjusted mean difference|-0.061|Standard Error of the Mean|0.024||0.0119|2-Sided|95.0|-0.109|-0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667137|NCT01431274|3068334|Superiority or Other||Adjusted mean difference|0.15|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.102|0.198||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667138|NCT01431274|3068334|Superiority or Other||Adjusted mean difference|0.027|Standard Error of the Mean|0.025|<|0.2661|2-Sided|95.0|-0.021|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667139|NCT01431274|3068334|Superiority or Other||Adjusted mean difference|0.111|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.063|0.159||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667323|NCT01429051|3068529|Superiority or Other||LS Mean Difference|1.1||||0.002|2-Sided|95.0|0.41|1.179|||Mixed Models Analysis|A mixed effects model with episode baseline PI as a covariate, treatment as a fixed effect and patient as a random effect.|||
1667707|NCT01421459|3069385|Superiority or Other|||||||0.326||||||P-value is for Lifestyle Flexibility at 12 weeks.|ANCOVA||||
1667140|NCT01431274|3068334|Superiority or Other||Adjusted mean difference|0.122|Standard Error of the Mean|0.024|<|0.0001||95.0|0.074|0.17||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667141|NCT01431274|3068334|Superiority or Other||Adjusted mean difference|0.05|Standard Error of the Mean|0.024|<|0.0426|2-Sided|95.0|0.002|0.098||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667142|NCT01431274|3068334|Superiority or Other||Adjusted mean difference|0.138|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.09|0.186||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667143|NCT01431274|3068334|Superiority or Other||Adjusted mean difference|0.077|Standard Error of the Mean|0.024|<|0.0017|2-Sided|95.0|0.029|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667144|NCT01431274|3068335|Superiority or Other||Adjusted mean difference|0.008|Standard Error of the Mean|0.013||0.5338|2-Sided|95.0|-0.017|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667145|NCT01431274|3068335|Superiority or Other||Adjusted mean difference|0.028|Standard Error of the Mean|0.013||0.0248|2-Sided|95.0|0.004|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667146|NCT01431274|3068335|Superiority or Other||Adjusted mean difference|0.036|Standard Error of the Mean|0.013||0.0041|2-Sided|95.0|0.011|0.06||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667147|NCT01431274|3068335|Superiority or Other||Adjusted mean difference|0.071|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.047|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667148|NCT01431274|3068335|Superiority or Other||Adjusted mean difference|0.024|Standard Error of the Mean|0.012|<|0.0554|2-Sided|95.0|-0.001|0.048||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667149|NCT01431274|3068335|Superiority or Other||Adjusted mean difference|0.04|Standard Error of the Mean|0.012|<|0.0014|2-Sided|95.0|0.015|0.064||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667150|NCT01431274|3068335|Superiority or Other||Adjusted mean difference|0.048|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.023|0.072||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667151|NCT01431274|3068335|Superiority or Other||Adjusted mean difference|0.076|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.051|0.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667152|NCT01431274|3068335|Superiority or Other||Adjusted mean difference|0.064|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.039|0.088||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667324|NCT01428713|3068542|Superiority or Other||Mean Difference (Final Values)|16.75|Standard Error of the Mean|4.87||0.01|||||||Mixed Models Analysis||Comparing Peds QL score value at baseline vs. end of 3 cycles for COCP||
1667708|NCT01421459|3069385|Superiority or Other|||||||0.89||||||P-value is for Lifestyle Flexibility at 4 weeks.|ANCOVA||||
1667153|NCT01431274|3068335|Superiority or Other||Adjusted mean difference|0.1|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.075|0.124||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667154|NCT01431274|3068336|Superiority or Other||Adjusted mean difference|0.003|Standard Error of the Mean|0.012||0.8083|2-Sided|95.0|-0.021|0.027||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667155|NCT01431274|3068336|Superiority or Other||Adjusted mean difference|0.014|Standard Error of the Mean|0.012||0.2476|2-Sided|95.0|-0.01|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667156|NCT01431274|3068336|Superiority or Other||Adjusted mean difference|0.017|Standard Error of the Mean|0.012||0.1617|2-Sided|95.0|-0.007|0.041||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667157|NCT01431274|3068336|Superiority or Other||Adjusted mean difference|0.065|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.041|0.089||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667158|NCT01431274|3068336|Superiority or Other||Adjusted mean difference|0.018|Standard Error of the Mean|0.012|<|0.136|2-Sided|95.0|-0.006|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667159|NCT01431274|3068336|Superiority or Other||Adjusted mean difference|0.044|Standard Error of the Mean|0.012|<|0.0004|2-Sided|95.0|0.019|0.068||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667160|NCT01431274|3068336|Superiority or Other||Adjusted mean difference|0.047|Standard Error of the Mean|0.012|<|0.0002|2-Sided|95.0|0.022|0.071||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667161|NCT01431274|3068336|Superiority or Other||Adjusted mean difference|0.061|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.037|0.085||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667162|NCT01431274|3068336|Superiority or Other||Adjusted mean difference|0.062|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.038|0.086||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667163|NCT01431274|3068336|Superiority or Other||Adjusted mean difference|0.079|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.055|0.103||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667164|NCT01431274|3068337|Superiority or Other||Adjusted mean difference|-0.007|Standard Error of the Mean|0.012||0.5759|2-Sided|95.0|-0.031|0.017||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667165|NCT01431274|3068337|Superiority or Other||Adjusted mean difference|0.019|Standard Error of the Mean|0.012||0.1171|2-Sided|95.0|-0.005|0.043||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667325|NCT01428713|3068542|Superiority or Other||Mean Difference (Final Values)|15.6|Standard Error of the Mean|5.08||0.03||||||P value < 0.05 is considered significant for this study|Mixed Models Analysis||Comparing Peds QL score value at baseline vs. end of 3 cycles for TA||
1667713|NCT01421459|3069386|Superiority or Other|||||||0.683||||||P-value is for ALBSS Total Score at 12 weeks.|ANCOVA||||
1667166|NCT01431274|3068337|Superiority or Other||Adjusted mean difference|0.012|Standard Error of the Mean|0.012||0.3118|2-Sided|95.0|-0.012|0.036||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667167|NCT01431274|3068337|Superiority or Other||Adjusted mean difference|0.069|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.045|0.093||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667168|NCT01431274|3068337|Superiority or Other||Adjusted mean difference|0.018|Standard Error of the Mean|0.012|<|0.1405|2-Sided|95.0|-0.006|0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667169|NCT01431274|3068337|Superiority or Other||Adjusted mean difference|0.058|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.034|0.082||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667170|NCT01431274|3068337|Superiority or Other||Adjusted mean difference|0.051|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.027|0.075||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667171|NCT01431274|3068337|Superiority or Other||Adjusted mean difference|0.07|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.046|0.094||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667172|NCT01431274|3068337|Superiority or Other||Adjusted mean difference|0.076|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.052|0.1||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667173|NCT01431274|3068337|Superiority or Other||Adjusted mean difference|0.088|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.064|0.112||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667174|NCT01431274|3068338|Superiority or Other||Adjusted mean difference|-0.009|Standard Error of the Mean|0.012||0.4601|2-Sided|95.0|-0.033|0.015||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667175|NCT01431274|3068338|Superiority or Other||Adjusted mean difference|0.014|Standard Error of the Mean|0.012||0.2401|2-Sided|95.0|-0.01|0.038||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667176|NCT01431274|3068338|Superiority or Other||Adjusted mean difference|0.005|Standard Error of the Mean|0.012||0.6619|2-Sided|95.0|-0.018|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667177|NCT01431274|3068338|Superiority or Other||Adjusted mean difference|0.066|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.042|0.09||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667178|NCT01431274|3068338|Superiority or Other||Adjusted mean difference|0.042|Standard Error of the Mean|0.012|<|0.0005|2-Sided|95.0|0.019|0.066||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667326|NCT01428713|3068542|Superiority or Other||Mean Difference (Final Values)|430.6|Standard Error of the Mean|157.35||0.03||||||P value < 0.05 is considered significant for this study|Mixed Models Analysis||Comparing PBAC score value at baseline vs. end of 3 cycles for COCP||
1667714|NCT01421459|3069386|Superiority or Other|||||||0.313||||||P-value is for ALBSS Total Score at 4 weeks.|ANCOVA||||
1667179|NCT01431274|3068338|Superiority or Other||Adjusted mean difference|0.033|Standard Error of the Mean|0.012|<|0.0072|2-Sided|95.0|0.009|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667180|NCT01431274|3068338|Superiority or Other||Adjusted mean difference|0.024|Standard Error of the Mean|0.012|<|0.0517|2-Sided|95.0|0.0|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667181|NCT01431274|3068338|Superiority or Other||Adjusted mean difference|0.038|Standard Error of the Mean|0.012|<|0.0018|2-Sided|95.0|0.014|0.062||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667182|NCT01431274|3068338|Superiority or Other||Adjusted mean difference|0.075|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.051|0.099||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667183|NCT01431274|3068338|Superiority or Other||Adjusted mean difference|0.08|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.057|0.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667184|NCT01431274|3068339|Superiority or Other||Adjusted mean difference|-0.007|Standard Error of the Mean|0.012||0.5641|2-Sided|95.0|-0.031|0.017||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667185|NCT01431274|3068339|Superiority or Other||Adjusted mean difference|0.016|Standard Error of the Mean|0.012||0.1777|2-Sided|95.0|-0.007|0.04||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667186|NCT01431274|3068339|Superiority or Other||Adjusted mean difference|0.009|Standard Error of the Mean|0.012||0.4407|2-Sided|95.0|-0.014|0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667187|NCT01431274|3068339|Superiority or Other||Adjusted mean difference|0.056|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.032|0.08||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667188|NCT01431274|3068339|Superiority or Other||Adjusted mean difference|0.026|Standard Error of the Mean|0.012|<|0.0347|2-Sided|95.0|0.002|0.049||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667189|NCT01431274|3068339|Superiority or Other||Adjusted mean difference|0.037|Standard Error of the Mean|0.012|<|0.0021|2-Sided|95.0|0.014|0.061||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667190|NCT01431274|3068339|Superiority or Other||Adjusted mean difference|0.03|Standard Error of the Mean|0.012|<|0.0122|2-Sided|95.0|0.007|0.054||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667191|NCT01431274|3068339|Superiority or Other||Adjusted mean difference|0.047|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.023|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667327|NCT01428713|3068542|Superiority or Other||Mean Difference (Final Values)|536.4|Standard Error of the Mean|162.12||0.01||||||P value < 0.05 is considered significant in this study|Mixed Models Analysis||Comparing PBAC score value at baseline vs. end of 3 cycles for TA||
1667715|NCT01421459|3069386|Superiority or Other|||||||0.966||||||P-value is for Worry domain at Endpoint, up to 24 weeks.|ANCOVA||||
1667192|NCT01431274|3068339|Superiority or Other||Adjusted mean difference|0.063|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.039|0.087||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667193|NCT01431274|3068339|Superiority or Other||Adjusted mean difference|0.072|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.049|0.096||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward-Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667194|NCT01431274|3068340|Superiority or Other||Adjusted mean difference|0.007|Standard Error of the Mean|0.013||0.6009|2-Sided|95.0|-0.018|0.031||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667195|NCT01431274|3068340|Superiority or Other||Adjusted mean difference|0.02|Standard Error of the Mean|0.013||0.1126|2-Sided|95.0|-0.005|0.045||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667196|NCT01431274|3068340|Superiority or Other||Adjusted mean difference|0.027|Standard Error of the Mean|0.013||0.0344|2-Sided|95.0|0.002|0.051||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667197|NCT01431274|3068340|Superiority or Other||Adjusted mean difference|0.121|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.097|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667198|NCT01431274|3068340|Superiority or Other||Adjusted mean difference|0.023|Standard Error of the Mean|0.013|<|0.0717|2-Sided|95.0|-0.002|0.047||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667199|NCT01431274|3068340|Superiority or Other||Adjusted mean difference|0.092|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.067|0.117||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667200|NCT01431274|3068340|Superiority or Other||Adjusted mean difference|0.099|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.074|0.123||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667201|NCT01431274|3068340|Superiority or Other||Adjusted mean difference|0.119|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.094|0.143||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667202|NCT01431274|3068340|Superiority or Other||Adjusted mean difference|0.115|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.09|0.139||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667203|NCT01431274|3068340|Superiority or Other||Adjusted mean difference|0.141|Standard Error of the Mean|0.013|<|0.0001|2-Sided|95.0|0.117|0.166||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667204|NCT01431274|3068341|Superiority or Other||Adjusted mean difference|-0.013|Standard Error of the Mean|0.012||0.2702|2-Sided|95.0|-0.037|0.01||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667328|NCT01428453|3068563|Superiority or Other||Mean Difference (Net)|0.07|||||2-Sided|95.0|-0.13|0.269|||||Comparison of attention composite score between placebo and rilapladib 250 mg at Week 24. A positive treatment difference indicates benefit, relative to placebo.||
1667716|NCT01421459|3069386|Superiority or Other|||||||0.86||||||P-value is for Worry domain at 12 weeks.|ANCOVA||||
1667205|NCT01431274|3068341|Superiority or Other||Adjusted mean difference|0.015|Standard Error of the Mean|0.012||0.2129|2-Sided|95.0|-0.009|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667206|NCT01431274|3068341|Superiority or Other||Adjusted mean difference|0.002|Standard Error of the Mean|0.012||0.8834|2-Sided|95.0|-0.022|0.026||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667207|NCT01431274|3068341|Superiority or Other||Adjusted mean difference|0.113|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.089|0.137||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667208|NCT01431274|3068341|Superiority or Other||Adjusted mean difference|0.017|Standard Error of the Mean|0.012|<|0.1569|2-Sided|95.0|-0.007|0.041||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667209|NCT01431274|3068341|Superiority or Other||Adjusted mean difference|0.109|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.085|0.133||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667210|NCT01431274|3068341|Superiority or Other||Adjusted mean difference|0.096|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.072|0.12||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667211|NCT01431274|3068341|Superiority or Other||Adjusted mean difference|0.111|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.087|0.135||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667212|NCT01431274|3068341|Superiority or Other||Adjusted mean difference|0.126|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.102|0.15||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667213|NCT01431274|3068341|Superiority or Other||Adjusted mean difference|0.128|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.104|0.152||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667214|NCT01431274|3068342|Superiority or Other||Adjusted mean difference|0.008|Standard Error of the Mean|0.012||0.5018|2-Sided|95.0|-0.016|0.032||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667215|NCT01431274|3068342|Superiority or Other||Adjusted mean difference|-0.056|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|-0.08|-0.033||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667216|NCT01431274|3068342|Superiority or Other||Adjusted mean difference|-0.048|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|-0.072|-0.025||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667217|NCT01431274|3068342|Superiority or Other||Adjusted mean difference|0.089|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.065|0.113||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667329|NCT01428453|3068563|Superiority or Other||Mean Difference (Net)|-0.063|||||2-Sided|95.0|-0.257|0.13|||||Comparison of attention composite score between placebo and rilapladib 250 mg at Week 12. A positive treatment difference indicates benefit, relative to placebo.||
1667717|NCT01421459|3069386|Superiority or Other|||||||0.237||||||P-value is for Worry domain at 4 weeks.|ANCOVA||||
1667218|NCT01431274|3068342|Superiority or Other||Adjusted mean difference|0.011|Standard Error of the Mean|0.012|<|0.3549|2-Sided|95.0|-0.013|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667219|NCT01431274|3068342|Superiority or Other||Adjusted mean difference|0.07|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.046|0.093||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667220|NCT01431274|3068342|Superiority or Other||Adjusted mean difference|0.078|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.054|0.101||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667221|NCT01431274|3068342|Superiority or Other||Adjusted mean difference|0.022|Standard Error of the Mean|0.012|<|0.0746|2-Sided|95.0|-0.002|0.045||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667222|NCT01431274|3068342|Superiority or Other||Adjusted mean difference|0.081|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.057|0.104||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667223|NCT01431274|3068342|Superiority or Other||Adjusted mean difference|0.033|Standard Error of the Mean|0.012|<|0.0067|2-Sided|95.0|0.009|0.056||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667224|NCT01431274|3068343|Superiority or Other||Adjusted mean difference|-0.062|Standard Error of the Mean|0.135||0.6457|2-Sided|95.0|-0.327|0.203||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667225|NCT01431274|3068343|Superiority or Other||Adjusted mean difference|0.126|Standard Error of the Mean|0.135||0.3525|2-Sided|95.0|-0.14|0.391||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667226|NCT01431274|3068343|Superiority or Other||Adjusted mean difference|0.064|Standard Error of the Mean|0.136||0.6382|2-Sided|95.0|-0.202|0.33||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667227|NCT01431274|3068343|Superiority or Other||Adjusted mean difference|0.294|Standard Error of the Mean|0.134||0.0289|2-Sided|95.0|0.03|0.557||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667228|NCT01431274|3068343|Superiority or Other||Adjusted mean difference|0.003|Standard Error of the Mean|0.134||0.9801|2-Sided|95.0|-0.259|0.266||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667229|NCT01431274|3068343|Superiority or Other||Adjusted mean difference|0.352|Standard Error of the Mean|0.135||0.0088|2-Sided|95.0|0.089|0.616||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667230|NCT01431274|3068343|Superiority or Other||Adjusted mean difference|0.29|Standard Error of the Mean|0.134||0.0307|2-Sided|95.0|0.027|0.554||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667407|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1183|Standard Error of the Mean|0.0194|<|0.0001|2-Sided|95.0|0.0795|0.1972|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7|
1667709|NCT01421459|3069385|Superiority or Other|||||||0.757||||||P-value is for Inconvenience of Regimen at Endpoint, up to 24 weeks.|ANCOVA||||
1667231|NCT01431274|3068343|Superiority or Other||Adjusted mean difference|0.416|Standard Error of the Mean|0.135||0.002|2-Sided|95.0|0.152|0.681||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667232|NCT01431274|3068343|Superiority or Other||Adjusted mean difference|0.356|Standard Error of the Mean|0.135||0.0082|2-Sided|95.0|0.092|0.619||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667233|NCT01431274|3068343|Superiority or Other||Adjusted mean difference|0.42|Standard Error of the Mean|0.135||0.0019|2-Sided|95.0|0.155|0.684||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667234|NCT01431274|3068344|Superiority or Other||Adjusted mean difference|0.115|Standard Error of the Mean|0.554||0.8355|2-Sided|95.0|-0.97|1.2||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667235|NCT01431274|3068344|Superiority or Other||Adjusted mean difference|-0.575|Standard Error of the Mean|0.556||0.3013|2-Sided|95.0|-1.664|0.515||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667236|NCT01431274|3068344|Superiority or Other||Adjusted mean difference|-0.46|Standard Error of the Mean|0.557||0.4097|2-Sided|95.0|-1.552|0.633||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg)~Spatial power covariance structure for within−patient errors."||
1667237|NCT01431274|3068344|Superiority or Other||Adjusted mean difference|-1.118|Standard Error of the Mean|0.549||0.0418|2-Sided|95.0|-2.195|-0.042||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667238|NCT01431274|3068344|Superiority or Other||Adjusted mean difference|-0.662|Standard Error of the Mean|0.545||0.2249|2-Sided|95.0|-1.731|0.407||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667239|NCT01431274|3068344|Superiority or Other||Adjusted mean difference|-0.571|Standard Error of the Mean|0.55||0.2988|2-Sided|95.0|-1.649|0.507||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667240|NCT01431274|3068344|Superiority or Other||Adjusted mean difference|-0.456|Standard Error of the Mean|0.548||0.4051|2-Sided|95.0|-1.531|0.618||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667241|NCT01431274|3068344|Superiority or Other||Adjusted mean difference|-1.031|Standard Error of the Mean|0.552||0.062|2-Sided|95.0|-2.113|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667242|NCT01431274|3068344|Superiority or Other||Adjusted mean difference|-1.233|Standard Error of the Mean|0.551||0.0252|2-Sided|95.0|-2.313|-0.153||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667243|NCT01431274|3068344|Superiority or Other||Adjusted mean difference|-1.693|Standard Error of the Mean|0.553||0.0022|2-Sided|95.0|-2.778|-0.608||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667408|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1396|Standard Error of the Mean|0.0139|<|0.0001|2-Sided|95.0|0.1117|0.173|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7|
1668914|NCT01400932|3071291|Superiority or Other||||||<|0.007||||||Week 1; NIL|ANCOVA||||
1667244|NCT01431274|3068345|Superiority or Other||Adjusted mean difference|-0.018|Standard Error of the Mean|0.012||0.1421|2-Sided|95.0|-0.041|0.006||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667245|NCT01431274|3068345|Superiority or Other||Adjusted mean difference|0.029|Standard Error of the Mean|0.012||0.0151|2-Sided|95.0|0.006|0.053||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667246|NCT01431274|3068345|Superiority or Other||Adjusted mean difference|0.012|Standard Error of the Mean|0.012||0.3326|2-Sided|95.0|-0.012|0.035||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667247|NCT01431274|3068345|Superiority or Other||Mean Difference (Final Values)|0.053|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.03|0.077||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667248|NCT01431274|3068345|Superiority or Other||Adjusted mean difference|0.024|Standard Error of the Mean|0.012|<|0.0407|2-Sided|95.0|0.001|0.048||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667249|NCT01431274|3068345|Superiority or Other||Adjusted mean difference|0.046|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.023|0.07||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667250|NCT01431274|3068345|Superiority or Other||Adjusted mean difference|0.029|Standard Error of the Mean|0.012|<|0.0174|2-Sided|95.0|0.005|0.052||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667251|NCT01431274|3068345|Superiority or Other||Adjusted mean difference|0.058|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.034|0.081||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667252|NCT01431274|3068345|Superiority or Other||Adjusted mean difference|0.071|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.047|0.094||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667253|NCT01431274|3068345|Superiority or Other||Adjusted mean difference|0.082|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.059|0.106||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667254|NCT01431274|3068346|Superiority or Other||Adjusted mean difference|-0.009|Standard Error of the Mean|0.012||0.4352|2-Sided|95.0|-0.032|0.014||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667255|NCT01431274|3068346|Superiority or Other||Adjusted mean difference|0.016|Standard Error of the Mean|0.012||0.1863|2-Sided|95.0|-0.007|0.039||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (2.5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667256|NCT01431274|3068346|Superiority or Other||Adjusted mean difference|0.006|Standard Error of the Mean|0.012||0.5849|2-Sided|95.0|-0.017|0.029||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tiotropium (5 µg) versus Olodaterol (5 µg).~Spatial power covariance structure for within−patient errors."||
1667409|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1688|Standard Error of the Mean|0.0142|<|0.0001|2-Sided|95.0|0.1403|0.1972|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7|
1667710|NCT01421459|3069385|Superiority or Other|||||||0.371||||||P-value is for Inconvenience of Regimen at 12 weeks.|ANCOVA||||
1667257|NCT01431274|3068346|Superiority or Other||Adjusted mean difference|0.108|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.085|0.13||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667258|NCT01431274|3068346|Superiority or Other||Adjusted mean difference|0.014|Standard Error of the Mean|0.012|<|0.2169|2-Sided|95.0|-0.008|0.037||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 µg) versus Tio+Olo FDC (2.5/5 µg).~Spatial power covariance structure for within−patient errors."||
1667259|NCT01431274|3068346|Superiority or Other||Adjusted mean difference|0.102|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.08|0.125||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (5 µg).~Spatial power covariance structure for within−patient errors."||
1667260|NCT01431274|3068346|Superiority or Other||Adjusted mean difference|0.093|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.07|0.116||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Tiotropium (2.5 µg).~Spatial power covariance structure for within−patient errors."||
1667261|NCT01431274|3068346|Superiority or Other||Adjusted mean difference|0.109|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.086|0.132||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (2.5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667262|NCT01431274|3068346|Superiority or Other||Adjusted mean difference|0.117|Standard Error of the Mean|0.012|<|0.0001||95.0|0.094|0.14||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Tiotropium (5 μg).~Spatial power covariance structure for within−patient errors."||
1667263|NCT01431274|3068346|Superiority or Other||Adjusted mean difference|0.123|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.1|0.146||Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect.|Mixed Models Analysis|Kenward−Roger approximation of denominator degrees of freedom.|"Tio+Olo FDC (5/5 μg) versus Olodaterol (5 μg).~Spatial power covariance structure for within−patient errors."||
1667264|NCT01431014|3068365|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1667265|NCT01430741|3068376|Superiority or Other||||||=|0|||||||Regression, Cox|||We used Kaplan-Meier survival curves to estimate the extent and timing of negative housing exits over time and Cox proportional hazards regression to assess the relationship between membership in the GTO group and risk of experiencing a negative housing exit, adjusting for a set of relevant covariates.|
1667266|NCT01430741|3068377|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Compared changes in mental health emergency department visits among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.|
1667267|NCT01430741|3068378|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Compared medical inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.|
1667268|NCT01430741|3068378|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Compared mental health inpatient hospitalizations among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.|
1667269|NCT01430741|3068379|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Compared changes in drug dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.|
1667270|NCT01430741|3068379|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Compared changes in alcohol dependence among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.|
1667271|NCT01430741|3068380|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Compared changes in service intensity among Veterans served by case managers in the GTO group relative to the comparison group of Veterans, by fitting a series of mixed-effects regression models. Final mixed-effect models for all outcomes included fixed terms for group (GTO group vs. comparison), time, group x time interaction as well as control covariates.|
1667272|NCT01430624|3068382|Superiority or Other|||||||0.4||||||6 month comparison|ANOVA|df = 2, 110|||
1667273|NCT01430624|3068382|Superiority or Other|||||||0.67||||||3 month comparison|ANOVA|df = 2, 127|||
1667274|NCT01430624|3068382|Superiority or Other|||||||0.15||||||6 week comparison|ANOVA|df = 2, 141|||
1667292|NCT01430468|3068408|Equivalence|With use of previously established criteria for a malpositioned glenoid, deviations of greater than 10 degrees of version from the planned placement were considered relevant.||||||0.05|||||||t-test, 2 sided|||The absolute difference between the actual outcome and the planned outcome was compared between the standard surgical group and the glenoid positioning system group with use of a Student t test. Results were considered to be significant at p < 0.05.|
1667293|NCT01430403|3068411|Superiority or Other||Mean Difference (Net)|-0.28|Standard Error of the Mean|1.52||0.86|2-Sided|95.0|-3.26|2.71|||Regression, Linear|Adjustments for site and dosing group.|||
1667294|NCT01430403|3068412|Superiority or Other||Mean Difference (Net)|-0.18|Standard Error of the Mean|1.48||0.9|2-Sided|95.0|-3.08|2.72|||Regression, Linear|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)|||
1667295|NCT01430403|3068413|Superiority or Other||Ratio|0.48|Standard Error of the Mean|0.39||0.06|2-Sided|95.0|0.23|1.02|||Negative Binomial Generalized Estimating|Adjustments for site and dosing group|||
1667296|NCT01430403|3068414|Superiority or Other||Ratio|0.72|Standard Error of the Mean|0.32||0.31|2-Sided|95.0|0.39|1.35|||Negative Binomial Generalized Estimating|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)|||
1667297|NCT01430403|3068415|Superiority or Other||Ratio|1.0|Standard Error of the Mean|0.63||0.99|2-Sided|95.0|0.29|3.46|||Negative Binomial Generalized Estimating|Adjustments for site and dosing group|||
1667298|NCT01430403|3068416|Superiority or Other||Rate Ratio|0.72|Standard Error of the Mean|0.68||0.63|2-Sided|95.0|0.19|0.72|||Negative Binomial Generalized Estimating|Adjustments for site, dosing group and treatment group step (2-4 as one step and 5 separately)|||
1667299|NCT01430403|3068417|Superiority or Other||Mean Difference (Net)|0.58|Standard Error of the Mean|0.37||0.12|2-Sided|95.0|-0.15|1.3|||Regression, Linear|Adjustments for randomization C-ACT, site and dosing group|||
1667300|NCT01430403|3068418|Superiority or Other||Mean Difference (Net)|0.71|Standard Error of the Mean|0.36||0.05|2-Sided|95.0|0.0|1.41|||Regression, Linear|Adjustments for randomization C-ACT, site, dosing group and treatment group step (2-4 as one step and 5 separately)|||
1667301|NCT01430403|3068419|Superiority or Other||Mean Difference (Net)|0.05|Standard Error of the Mean|0.41||0.89|2-Sided|95.0|-0.76|0.86|||Regression, Linear|Adjustments for randomization ACT, site and dosing group.|||
1667302|NCT01430403|3068420|Superiority or Other||Mean Difference (Net)|1.11|Standard Error of the Mean|0.4||0.006|2-Sided|95.0|0.32|1.9|||Regression, Linear|Adjustments for randomization ACT, site, dosing group and treatment group step (2-4 as one step and 5 separately)|||
1667303|NCT01430403|3068421|Superiority or Other||Mean Difference (Net)|1.15|Standard Error of the Mean|0.89||0.2|2-Sided|95.0|-0.61|2.91|||Regression, Linear|Adjustments for randomization FEV1:FVCx100, site and dosing group.|||
1667304|NCT01430403|3068422|Superiority or Other||Mean Difference (Net)|0.25|Standard Error of the Mean|0.89||0.78|2-Sided|95.0|-1.49|1.99|||Regression, Linear|Adjustments for randomization FEV1:FVCx100, site, dosing group and treatment group step (2-4 as one step and 5 separately)|||
1667305|NCT01430403|3068423|Superiority or Other||Median Difference (Net)|2.37|Standard Error of the Mean|1.59||0.14|2-Sided|95.0|-0.76|5.51|||Regression, Linear|Adjustments for randomization FEV1 % predicted, site and dosing group.|||
1667306|NCT01430403|3068424|Superiority or Other||Mean Difference (Net)|-0.32|Standard Error of the Mean|1.58||0.84|2-Sided|95.0|-3.42|2.78|||Regression, Linear|Adjustments for randomization FEV1 % predicted, site, dosing group and treatment group step (2-4 as one step and 5 separately)|||
1667307|NCT01430403|3068425|Superiority or Other||Mean Difference (Net)|-0.26|Standard Error of the Mean|0.3||0.39|2-Sided|95.0|-0.86|0.34|||Regression, Linear|Adjustments for randomization CASI, site and dosing group|||
1667308|NCT01430403|3068426|Superiority or Other||Mean Difference (Net)|-0.52|Standard Error of the Mean|0.3||0.09|2-Sided|95.0|-1.11|0.07|||Regression, Linear|Adjustments for randomization CASI, site, dosing group and treatment group step (2-4 as one step and 5 separately)|||
1667309|NCT01430403|3068427|Superiority or Other||Odds Ratio (OR)|1.12||||0.37|2-Sided|95.0|0.87|1.44|||Chi-squared||||
1667310|NCT01430403|3068427|Superiority or Other||Odds Ratio (OR)|1.06||||0.552|2-Sided|95.0|0.87|1.31|||Chi-squared||||
1667311|NCT01430403|3068428|Superiority or Other||Linear Regression|-0.13||||0.33|2-Sided|95.0|-0.4|0.13|||F-Test||||
1667312|NCT01430403|3068428|Superiority or Other||Linear Regression|0.004||||0.94|2-Sided|95.0|-0.1|0.11|||F-Test||||
1667313|NCT01430403|3068429|Superiority or Other||Odds Ratio (OR)|3.53|||<|0.01|2-Sided|95.0|2.38|5.22|||Chi-squared||Adjusted for site||
1667314|NCT01430403|3068430|Superiority or Other||Odds Ratio (OR)|0.73|Standard Error of the Mean|0.41||0.45|2-Sided|95.0|0.33|1.64|||Odds Ratio|Adjusted for Site, dosing group and treatment step|ICS Boost serves as the reference group. Values < 1 represent more exacerbations in the ICS arm.|Null hypothesis is that there is no difference between the arms. Power calculation is described in detail in the study protocol.|
1667315|NCT01430403|3068431|Superiority or Other||Odds Ratio (OR)|0.48|Standard Error of the Mean|0.331||0.03|2-Sided|95.0|0.25|0.92|||Odds Ratio|Adjusted for Site, dosing group and treatment step|Placebo serves as the reference group. Values < 1 represent more exacerbations in the placebo arm.|Null hypothesis is that there is no difference between the arms. Power calculation is described in detail in the study protocol.|
1667316|NCT01430182|3068436|Superiority or Other|||||||0.37|||||||t-test, 1 sided|unpaired|||
1667317|NCT01429623|3068480|Superiority||Mean Difference (Net)|0.79|Standard Error of the Mean|1.17|<|0.97|2-Sided||||||Mixed Models Analysis||||
1667318|NCT01429623|3068481|Superiority||Mean Difference (Net)|-0.066|Standard Error of the Mean|0.085|<|0.32|2-Sided||||||Mixed Models Analysis||||
1667319|NCT01429623|3068482|Superiority||Mean Difference (Net)|0.37|Standard Error of the Mean|0.24|<|0.61|2-Sided||||||Mixed Models Analysis||||
1667320|NCT01429623|3068483|Superiority||Odds Ratio (OR)|1.55|||<|0.16|2-Sided|95.0|0.74|3.25|||Log Rank||||
1667321|NCT01429454|3068490|Superiority||||||>|0.1|||||||Mixed Models Analysis||||
1667322|NCT01429454|3068491|Superiority||Cox Proportional Hazard|0.36||||0.51|2-Sided||||||Chi-squared||||
1667711|NCT01421459|3069385|Superiority or Other|||||||0.983||||||P-value is for Inconvenience of Regimen at 4 weeks.|ANCOVA||||
1667330|NCT01428453|3068564|Superiority or Other||Mean Difference (Net)|0.138||||0.982|2-Sided|95.0|0.01|0.267||The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Overall Composite Score, Treatment by Visit and Baseline Overall Composite Score by Visit.|Mixed-Model Repeated Measures analysis|The probability (effect size) for change from Baseline in CogState battery overall composite score >0 is presented.|A positive treatment difference indicates benefit, relative to placebo. Comparison of overall composite score between placebo and rilapladib 250 mg at Week 24.||
1667331|NCT01428453|3068564|Superiority or Other||Mean Difference (Net)|-0.067|||||2-Sided|95.0|-0.191|0.057|||||"The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Score, Treatment by Visit and Baseline Score by Visit. A positive treatment difference indicates benefit, relative to placebo.~placebo."||
1667332|NCT01428453|3068566|Superiority or Other||Mean Difference (Net)|-0.003|||||2-Sided|95.0|-0.016|0.01|||||The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.||
1667333|NCT01428453|3068567|Superiority or Other||Mean Difference (Net)|1.0||||||95.0|-10.2|12.2|||||Comparison of Abeta40 between placebo and rilapladib 250 mg. The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.||
1667334|NCT01428453|3068567|Superiority or Other||Mean Difference (Net)|-1.3|||||2-Sided|95.0|-3.9|1.2|||||Comparison of Abeta42 between placebo and rilapladib 250 mg. The analysis method for Plasma parameters was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline, Treatment by Visit, Baseline by Visit and Age.||
1667335|NCT01428453|3068568|Superiority or Other||Mean Difference (Net)|-0.24|Standard Error of the Mean|0.256||0.828|2-Sided|95.0|-0.74|0.26|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Albumin Quotient and Age.|||
1667336|NCT01428453|3068569|Superiority or Other||Mean Difference (Net)|0.167||||0.026|2-Sided|95.0|0.021|0.313||The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline Working Memory/Executive Function Composite Score, Treatment by Visit and Baseline Working Memory/Executive Function Composite Score by Visit.|Mixed-Model Repeated Measures analysis||A positive treatment difference indicates benefit, relative to placebo.||
1667337|NCT01428453|3068570|Superiority or Other||Mean Difference (Net)|-3.0|Standard Error of the Mean|2.46||0.892|2-Sided|95.0|-7.9|1.8|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF P-tau and Age.|Comparison of P-tau between placebo and rilapladib 250 mg.||
1667338|NCT01428453|3068570|Superiority or Other||Mean Difference (Net)|-57.1|Standard Error of the Mean|44.4||0.902|2-Sided|95.0|-144.5|30.3|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF tau and Age.|Comparison of CSF tau between placebo and rilapladib 250 mg.||
1667339|NCT01428453|3068571|Superiority or Other||Mean Difference (Net)|0.016|||||2-Sided|95.0|-0.003|0.036|||||The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Ratio Abeta1-42/Abeta1-40 and Age.||
1667340|NCT01428453|3068572|Superiority or Other||Mean Difference (Net)|-250.3|Standard Error of the Mean|265.66||0.829|2-Sided|95.0|-771.9|271.2|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Abeta1-40 and Age.|Comparison of CSF Abeta40 between placebo and rilapladib 250 mg.||
1667341|NCT01428453|3068572|Superiority or Other||Mean Difference (Net)|39.8||||0.133|2-Sided|95.0|-12.4|92.0|||ANCOVA|The analysis method was ANCOVA adjusted for Treatment, Baseline CSF Abeta1-42 and Age.|Comparison of CSF Abeta42 between placebo and rilapladib 250 mg.||
1667342|NCT01428336|3068574|Non-Inferiority|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.19|||||2-Sided|95.0|-0.94|-0.14||||||Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT - free cortisol|
1667343|NCT01428336|3068574|Non-Inferiority|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.18|||||2-Sided|95.0|-0.91|-0.15||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT - free cortisol|
1667344|NCT01428336|3068574|Non-Inferiority|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|0.12|||||2-Sided|95.0|-0.24|0.65||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT - free cortisol|
1667345|NCT01428336|3068575|Non-Inferiority|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.06|||||2-Sided|95.0|-0.65|0.04||||||Analysis comparing Peak 25ug CST correlation with ITT vs. 30-minute 250ug CST correlation with ITT|
1667346|NCT01428336|3068575|Non-Inferiority|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|-0.07|||||2-Sided|95.0|-0.69|-0.01||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 250ug CST correlation with ITT|
1667347|NCT01428336|3068575|Non-Inferiority|A non-inferiority region of 0.15 for the difference in correlations is expected.|Difference in correlation|0.06|||||2-Sided|95.0|-0.2|0.6||||||Analysis comparing Peak 25ug CST correlation with ITT vs. Peak 1ug CST correlation with ITT|
1667348|NCT01428258|3068579|Other|||||||0.0001|||||||ANOVA||||
1667349|NCT01428258|3068580|Other|||||||0.797|||||||t-test, 2 sided||||
1667350|NCT01428258|3068581|Other|||||||0.902|||||||t-test, 2 sided||||
1667351|NCT01428258|3068582|Other|||||||0.576|||||||ANOVA||||
1667352|NCT01428258|3068583|Other|||||||0.044|||||||ANCOVA||||
1667353|NCT01428258|3068583|Other|||||||0.136|||||||ANCOVA||||
1667354|NCT01428258|3068583|Superiority or Other||Mean Difference (Net)|-147.0|Standard Error of the Mean|39.0||0.0008|2-Sided||||||ANCOVA||||
1667355|NCT01427920|3068637|Superiority or Other||Estimated treatment difference, Mean|0.13||||0.659||95.0|-0.44|0.69|||Regression, Linear|Model includes treatment, strata and region as factors and relevant baseline FPG as covariate.||H0: D = 0.0% against HA: D ≠ 0.0%, where D is the mean treatment difference (subject-driven titration minus investigator-driven titration).|
1667356|NCT01427920|3068638|Non-Inferiority or Equivalence|Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.|Estimated treatment difference, Mean|0.26||||||95.0|0.05|0.48||||||PP|
1667357|NCT01427920|3068639|Non-Inferiority or Equivalence|Non-inferiority for subject-driven vs. investigator driven titration would be concluded if the upper bound of the two-sided 95% CI was below or equal to 0.4%.|Estimated treatment difference, Mean|0.25||||||95.0|0.04|0.46||||||FAS|
1667358|NCT01427738|3068673|Superiority or Other||Difference in proportion with clinical e|0.044|||||2-Sided|95.1|-0.077|0.166||||||Repeated confidence intervals (RCIs) were used to control type I error.A interim analysis was conducted by a 99.7% CI. The final analyses use a 95.1% CI, based on the Lan-DeMets error-spending function corresponding to the O’Brien-Fleming boundary.76% of 100 participant in arm GV had cure or improvement of OC after 14 days of treatment, and 71.6% of 102 in arm nystatin had cure or improvement of OC. Difference in clinical efficacy rates between GV and nystatin 95.1% CI is 0.044 (-0.077, 0.166).|
1667359|NCT01426958|3068700|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|92.46|Standard Deviation|11.9||0.0003|2-Sided|90.0|86.928|98.341||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation||
1667360|NCT01426958|3068700|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|110.76|Standard Deviation|10.0||0.0005|2-Sided|90.0|104.936|116.913||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation||
1667361|NCT01426958|3068700|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|118.56|Standard Deviation|11.5||0.0702|2-Sided|90.0|111.712|125.822||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation||
1667362|NCT01426958|3068701|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|99.75|Standard Deviation|12.8||0|2-Sided|90.0|93.328|106.61||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation||
1667363|NCT01426958|3068701|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|105.09|Standard Deviation|16.1||0.0012|2-Sided|90.0|96.425|114.53||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation||
1667364|NCT01426958|3068701|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|104.06|Standard Deviation|14.2||0.0002|2-Sided|90.0|96.681|112.002||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation||
1667365|NCT01426958|3068702|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|91.9|Standard Deviation|11.6||0.0004|2-Sided|90.0|86.519|97.614||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation||
1667366|NCT01426958|3068702|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|110.23|Standard Deviation|10.9||0.0009|2-Sided|90.0|103.837|117.006||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation||
1667367|NCT01426958|3068702|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|119.3|Standard Deviation|11.5||0.1009|2-Sided|90.0|112.239|126.811||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation||
1667368|NCT01426854|3068705|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1667369|NCT01426438|3068738|Superiority or Other|||||||0.19|||||||Sign test|Stratified exact Wilcoxon signed rank test. Stratified by screening HDL-C level and statin use within 90 days prior to study entry.|||
1667370|NCT01426438|3068738|Superiority or Other|||||||0.28|||||||Sign test|Stratified exact Wilcoxon signed rank test. Stratified by screening HDL-C level and statin use within 90 days prior to study entry.|||
1667371|NCT01426425|3068739|Superiority or Other||Chronic effectiveness prob at 6 months|0.973|||<|0.0001|2-Sided|95.0|0.95|0.985|||Kaplan-Meier log-log 95% CI||The chronic effectiveness success probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: PE ≤ 0.80~Ha: PE > 0.80~Where PE is the probability of a subject achieving chronic effectiveness success at 6-month follow-up, and 0.80 is the pre-specified performance goal. As pre-defined in the study protocol, this hypothesis is tested if the primary effectiveness objective null hypothesis (Ho) is rejected."|
1667372|NCT01426425|3068740|Superiority or Other||Safety failure probability at 6 months|0.01|||<|0.0001|2-Sided|95.0|0.004|0.027|||Kaplan-Meier log-log 95% CI||The chronic safety failure probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: Ps ≥ 0.07~Ha: Ps < 0.07~Where Ps is the probability of a subject experiencing at least one safety event through 6 months with a 0.07 pre-specified performance goal."|
1667373|NCT01426425|3068741|Superiority or Other||Chronic effectiveness prob at 6 months|0.926|||<|0.0001|2-Sided|95.0|0.895|0.948|||Kaplan-Meier log-log 95% CI||The chronic effectiveness success probability at 6 months was estimated using the Kaplan-Meier method. The standard error was approximated using Greenwood's formula. A two-sided 95% log-log confidence interval for the probability was constructed.|"The following hypothesis was tested at a one-sided 0.025 significance level.~Ho: PE ≤ 0.83~Ha: PE > 0.83~Where PE is the probability of a subject achieving chronic effectiveness success at the 6-month follow-up and 0.83 (83%) is the pre-specified performance goal."|
1667374|NCT01426386|3068748|Other|Treatment groups were compared using the chi-squared test.||||||0.248||||||No adjustment for multiplicity was applied for the secondary endpoints|Chi-squared||||
1667375|NCT01426386|3068750|Other|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|3.2|||<|0.001|2-Sided|95.0|1.71|4.78||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Fertilised oocytes as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model|
1667410|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.145|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.1169|0.173|||ANCOVA||standard error of the Mean difference|AUC 0-24 on day 7|
1667411|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1271|Standard Error of the Mean|0.0139|<|0.0001|2-Sided|95.0|0.0993|0.1548|||ANCOVA||standard error of the Mean difference|AUC0-24 on Day 7|
1667376|NCT01426386|3068752|Other|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|0.8|||<|0.001|2-Sided|95.0|0.56|1.11||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Log(estradiol) as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor, log(dose) and log(baseline estradiol) as covariates||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model|
1667377|NCT01426386|3068753|Other|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|11.1|||<|0.001|2-Sided|95.0|6.78|15.48||No adjustment for multiplicity was applied for the secondary endpoints|ANCOVA|Follicular volume as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model|
1667378|NCT01426386|3068754|Other|Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero)|Slope of the dose-response curve|7.9|||<|0.001|2-Sided|95.0|5.69|10.18||The a priori threshold for statistical significance was 5% (two-sided)|ANCOVA|Number of oocytes retrieved as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate||The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model|
1667379|NCT01426217|3068781|Other|Efficacy|Odds Ratio (OR)|0.91|||||2-Sided|95.0|0.62|1.35|||||||
1667380|NCT01426217|3068782|Other|Efficacy|Odds Ratio (OR)|0.79|||||2-Sided|95.0|0.63|0.98|||||||
1667381|NCT01426191|3068783|Other|||||||0.01|||||||Fisher Exact||||
1667382|NCT01426191|3068784|Other|||||||0.05|||||||Fisher Exact||||
1667383|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.0993|Standard Error of the Mean|0.0202|<|0.0001|2-Sided|95.0|0.0589|0.1398|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7|
1667384|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1048|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.0747|0.135|||ANCOVA||standard error of the Mean difference||
1667385|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1532|Standard Error of the Mean|0.0153|<|0.0001|2-Sided|95.0|0.1226|0.1838|||ANCOVA||standard error of the Mean difference||
1667386|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1175|Standard Error of the Mean|0.0151|<|0.0001|2-Sided|95.0|0.0872|0.1478|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7|
1667387|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1088|Standard Error of the Mean|0.015|<|0.0001|2-Sided|95.0|0.0788|0.1388|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7|
1667388|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.0879|Standard Error of the Mean|0.0153|<|0.0001|2-Sided|95.0|0.0573|0.1186|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 7|
1667389|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.0934|Standard Error of the Mean|0.0221|<|0.0001|2-Sided|95.0|0.049|0.1377|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1|
1667390|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1369|Standard Error of the Mean|0.0154|<|0.0001|2-Sided|95.0|0.1061|0.1678|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1|
1667391|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1299|Standard Error of the Mean|0.0158|<|0.0001|2-Sided|95.0|0.0982|0.1617|||ANCOVA||standard error of the Mean difference|AUC 12-24 o day 1|
1667392|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.0829|Standard Error of the Mean|0.0155|<|0.0001|2-Sided|95.0|0.0519|0.1139|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1|
1667393|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.0918|Standard Error of the Mean|0.0154|<|0.0001|2-Sided|95.0|0.0611|0.1226|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1|
1667394|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.0471|Standard Error of the Mean|0.0157|<|0.0001|2-Sided|95.0|0.0155|0.0786|||ANCOVA||standard error of the Mean difference|AUC 12-24 on day 1|
1667395|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1384|Standard Error of the Mean|0.0216|<|0.0001|2-Sided|95.0|0.0951|0.1817|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7|
1667396|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1697|Standard Error of the Mean|0.0152|<|0.0001|2-Sided|95.0|0.1393|0.201|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7|
1667397|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1814|Standard Error of the Mean|0.0155|<|0.0001|2-Sided|95.0|0.1503|0.2125|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7|
1667398|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1699|Standard Error of the Mean|0.0152|<|0.0001|2-Sided|95.0|0.1393|0.2004|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7|
1667399|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1454|Standard Error of the Mean|0.0151|<|0.0001|2-Sided|95.0|0.1151|0.1756|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 7|
1667400|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1279|Standard Error of the Mean|0.0154|<|0.0001|2-Sided|95.0|0.097|0.1587|||ANCOVA|standard error of the Mean difference|standard error of the Mean difference|AUC 0-12 on day 7|
1667401|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1248|Standard Error of the Mean|0.0188|<|0.0001|2-Sided|95.0|0.0872|0.1625|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1|
1667402|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1994|Standard Error of the Mean|0.0128|<|0.0001|2-Sided|95.0|0.1738|0.2251|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1|
1667403|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1919|Standard Error of the Mean|0.0132|<|0.0001|2-Sided|95.0|0.1655|0.2184|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1|
1667404|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1579|Standard Error of the Mean|0.0128|<|0.0001|2-Sided|95.0|0.1322|0.1837|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1|
1667405|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1468|Standard Error of the Mean|0.0128|<|0.0001|2-Sided|95.0|0.1212|0.1724|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1|
1667406|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1038|Standard Error of the Mean|0.0131|<|0.0001|2-Sided|95.0|0.0776|0.1301|||ANCOVA||standard error of the Mean difference|AUC 0-12 on day 1|
1667412|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1095|Standard Error of the Mean|0.0141|<|0.0001|2-Sided|95.0|0.0812|0.1379|||ANCOVA||standard error of the Mean difference|AUC 0-24 on Day 7|
1667413|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1095|Standard Error of the Mean|0.0189|<|0.0001|2-Sided|95.0|0.0716|0.1473|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1|
1667414|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.169|Standard Error of the Mean|0.0128|<|0.0001|2-Sided|95.0|0.1434|0.1946|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1|
1667415|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1625|Standard Error of the Mean|0.0131|<|0.0001|2-Sided|95.0|0.1362|0.1888|||ANCOVA||standard error of the Mean difference|AUC 0-24 day 1|
1667416|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.1222|Standard Error of the Mean|0.0128|<|0.0001|2-Sided|95.0|0.0965|0.1479|||ANCOVA||standard error of the Mean difference|AUC 0-24 Day 1|
1667417|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.122|Standard Error of the Mean|0.0127|<|0.0001|2-Sided|95.0|0.0965|0.1475|||ANCOVA||standard error of the Mean difference|ACU 0-24 Day 1|
1667418|NCT01426009|3068791|Superiority||Least Squares Mean Difference (SE)|0.0767|Standard Error of the Mean|0.0131|<|0.0001|2-Sided|95.0|0.0505|0.1028|||ANCOVA||standard error of the mean difference|ACU 0-24 on Day 1|
1667419|NCT01426009|3068792|Superiority|Day 1 analysis|Least Squares Mean|0.0501|Standard Error of the Mean|0.018||0.0074|2-Sided|95.0|0.014|0.0861|||ANCOVA|||An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.|
1667420|NCT01426009|3068792|Superiority|Day 1 analysis|Least Squares Mean Difference (SE)|0.0696|Standard Error of the Mean|0.0179||0.0003|2-Sided|95.0|0.0337|0.1055|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.|
1667421|NCT01426009|3068792|Superiority|Day 1 analysis|Least Squares Mean Difference (SE)|0.0385|Standard Error of the Mean|0.0183||0.0402|2-Sided|95.0|0.0018|0.0752|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.|
1667422|NCT01426009|3068792|Superiority|Day 7 analysis|Least Squares Mean Difference (SE)|0.0813|Standard Error of the Mean|0.0284||0.006|2-Sided|95.0|0.0243|0.1382|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.|
1667423|NCT01426009|3068792|Superiority|Day 7 analysis|Least Squares Mean Difference (SE)|0.0446|Standard Error of the Mean|0.0186||0.02|2-Sided|95.0|0.0073|0.082|||Mantel Haenszel||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.|
1667424|NCT01426009|3068792|Superiority|Day 7 analysis|Least Squares Mean Difference (SE)|0.1299|Standard Error of the Mean|0.019|<|0.0001|2-Sided|95.0|0.0918|0.1681|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.|
1667425|NCT01426009|3068792|Superiority|Day 7 analysis|Least Squares Mean Difference (SE)|0.1021|Standard Error of the Mean|0.0188|<|0.0001|2-Sided|95.0|0.0644|0.1398|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response, with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.|
1667426|NCT01426009|3068792|Superiority|Day 7 analysis|Least Squares Mean Difference (SE)|0.0676|Standard Error of the Mean|0.0184|<|0.0006|2-Sided|95.0|0.0307|0.1046|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response,with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence.A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.|
1667496|NCT01424397|3069119|Superiority or Other||Mean Difference (Net)|-0.52|Standard Error of the Mean|0.13|||2-Sided|90.0|-0.74|-0.31|||||||
1667497|NCT01424397|3069119|Superiority or Other||Mean Difference (Net)|-0.01|Standard Error of the Mean|0.173|||2-Sided|90.0|-0.3|0.27|||||||
1667498|NCT01424397|3069119|Superiority or Other||Mean Difference (Net)|-0.68|Standard Error of the Mean|0.113|||2-Sided|90.0|-0.87|-0.49|||||||
1667427|NCT01426009|3068792|Superiority|Day 7 analysis|Least Squares Mean Difference (SE)|0.0723|Standard Error of the Mean|0.0188|<|0.0003|2-Sided|95.0|0.0347|0.1099|||ANCOVA||Standard Error of the Mean Difference|An ANCOVA was used with change from baseline in trough FEV1 as the response,with factors for treatment, period, sequence, baseline as a covariate and a random effect for subject nested within sequence. A sample size of 30 subjects per comparison(133 total with dropouts)provides 90% power to detect a 0.12L difference in mean change trough FEV1 between active and placebo at an alpha of 0.05 using a 2-tailed t-test and assuming a within-subject standard deviation for change in trough FEV1 of 0.2.|
1667428|NCT01425814|3068824|Superiority or Other||Least Squares Mean Difference|0.102|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.062|0.141|||ANCOVA||||
1667429|NCT01425814|3068824|Superiority or Other||Least Squares Mean Difference|0.203|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.164|0.242|||ANCOVA||||
1667430|NCT01425814|3068824|Superiority or Other||Least Squares Mean Difference|0.233|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.194|0.273|||ANCOVA||||
1667431|NCT01425814|3068824|Superiority or Other||Least Squares Mean Difference|0.259|Standard Error of the Mean|0.02|<|0.0001|2-Sided|95.0|0.219|0.298|||ANCOVA||||
1667432|NCT01425801|3068840|Superiority or Other||Least Squares Mean Difference|0.274|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.221|0.327|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate|||
1667433|NCT01425801|3068840|Superiority or Other||Least Squares Mean Difference|0.322|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.269|0.375|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate|||
1667434|NCT01425801|3068840|Superiority or Other||Least Squares Mean Difference|0.371|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.318|0.424|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate|||
1667435|NCT01425801|3068840|Superiority or Other||Least Squares Mean DIfference|0.405|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.353|0.458|||ANCOVA|Sequence, treatment and period as fixed effect factors, patient within sequence as random effect and baseline peak FEV1 at each period as a covariate|||
1667436|NCT01425463|3068873|Non-Inferiority or Equivalence|Noninferiority of the investigational drug (Ferrous (II) Glycine Sulphate Complex) to the reference drug (Polyferose) was concluded if the lower limit of the two-sided 95 % confidence interval was greater than -7.0 g/L.|LS-Mean of ANCOVA|-2.19|||||2-Sided|95.0|-8.47|4.09|||||||
1667437|NCT01425359|3068878|Superiority or Other|||||||0.003||||||Sublingual nitroglycerin use frequency was compared by fitting a generalized linear model with log link and negative binomial distribution response.|Generalized linear model||||
1667438|NCT01425359|3068879|Superiority or Other|||||||0.008||||||Angina frequency was compared by fitting a generalized linear model with log link and negative binomial distribution response.|Generalized linear model||||
1667439|NCT01425307|3068880|Superiority or Other|||||||0.0011|||||||t-test, 2 sided||||
1667440|NCT01425307|3068890|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1667441|NCT01425307|3068894|Non-Inferiority or Equivalence|We hypothesized that the Alternative arm mean TCD velocity at 24 months will be less than the Standard arm mean TCD velocity plus 15cm/sec. We used Lan-DeMets boundaries to control overall Type I error rate at α = 0.05. For looks at exactly 1/3, 2/3, and 100 percent of the completed subjects, the cumulative α were estimated to be 0.0001, 0.001, and 0.05, respectively.|Mean Difference (Final Values)|4.54|||<|0.05|2-Sided|95.0|0.1|8.98||P value for non inferiority was 8.82 X 10^-16|Mixed Models Analysis|Linear mixed model||Participants were randomized at a central site, stratified by site with a block size of four, and an adaptive randomization scheme was used to balance the covariates of baseline age and TCD velocity. The treatment period lasted 24 months. The primary study endpoint was the 24 month TCD velocity calculated from a general linear mixed model, with the non-inferiority margin set at 15 cm/s. The primary analysis was done in the intention-to-treat population.|
1667442|NCT01425281|3068999|Non-Inferiority|Using t-test with non-inferiority margin of 0.140mm||||||0.78|||||||t-test, 2 sided|"Null and alternative hypotheses for superiority testing.~H0: EndpointABSORB BVS = EndpointXIENCE H1: EndpointABSORB BVS ≠ EndpointXIENCE"||Follow-up angiographic analysis was available for 298 lesions in the Absorb arm and 151 lesions in the Xience arm.|
1667443|NCT01425281|3069000|Superiority|||||||0.49|||||||t-test, 2 sided|"Null and alternative hypotheses for superiority testing.~H0: EndpointABSORB BVS = EndpointXIENCE H1: EndpointABSORB BVS ≠ EndpointXIENCE"||Angiographic vasomotion reactivity following nitrate administration, the test was analyzable for 388 paired lesions (Absorb arm [258 lesions] vs Xience arm [130 lesions]).|
1667444|NCT01425268|3069001|Superiority||||||<|0.0001|||||||Kaplan-Meier Log Rank test|Subjects not completing tissue expansion are censored in the analysis|||
1667445|NCT01425268|3069002|Non-Inferiority|Assuming that the success rate for both expanders was 95%, at least 92 breasts implanted with a AeroForm Tissue Expander and 46 breasts implanted with a saline expander were needed to be 80% confident (i.e., have a statistical power of 80%) that the lower bound of the one-sided 95% Confidence Interval for the difference in the Success rates (πTreatment – πControl) was greater than or equal to -10%.|margin of non-inferiority|-7.3|||||1-Sided|95.0|-7.3241||||||The Treatment Success Rate per breast is 96.1% (149/155) for AeroForm and 98.8% (82/83) for saline.The difference (AeroForm - saline) is -2.7% with a lower confidence limit of -7.3%, meeting the non-inferiority margin of > -10%.|The study was powered to show that the Treatment Success rate for the AeroForm System (πTreatment) was not worse than the rate for the saline expander (πControl) by more than 10% (-0.10 < πTreatment – πControl).|
1667446|NCT01425203|3069005|Superiority or Other||Adjusted Difference in Percentages|45.6|||<|0.0001|2-Sided|95.0|33.2|57.0|||Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen & Nurminen method.|The percentage of participants achieving EVR at TW8 was compared using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors in the FAS population.|
1667499|NCT01424397|3069120|Superiority or Other||Mean Difference (Net)|-8.95|Standard Error of the Mean|14.592|||2-Sided|90.0|-33.1|15.22||||||FP 200 μg versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr|
1667712|NCT01421459|3069386|Superiority or Other|||||||0.765||||||P-value is for ALBSS Total Score at Endpoint, up to 24 weeks.|ANCOVA||||
1667447|NCT01425203|3069006|Superiority or Other||Adjusted Difference in Percentages|30.2|||<|0.0001|2-Sided|95.0|17.3|42.5||Multiplicity adjustment for controlling type 1 error for key secondary comparison based on a step-down approach. Key-secondary comparison was tested only if statistical significance of primary comparison was met at alpha level of 0.050.|Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen & Nurminen method.|The key secondary statistical comparison was conducted on the mITT using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors.|
1667448|NCT01425203|3069007|Superiority or Other||Adjusted Difference in Percentages|29.2|||<|0.0001|2-Sided|95.0|16.4|41.5||Multiplicity adjustment for controlling type 1 error for the primary comparison was based on the step-down approach.|Miettinen and Nurminen Method||The difference, 95% CI and p-value are adjusted by stratification factors of IL-28B genotype and previous treatment, based on the Miettinen & Nurminen method.|The primary statistical comparison was conducted on the FAS using the stratified Miettinen and Nurminen method at alpha level of 0.050 adjusted for stratification factors, including IL28B genotype and previous treatment as specified at the time of randomization.|
1667449|NCT01424813|3069025|Superiority or Other||Mean Difference (Final Values)|0.68|Standard Error of the Mean|0.154|<|0.0001|2-Sided|95.0|0.38|0.99||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially [day 1, then day 8, then day 85] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.|||
1667450|NCT01424813|3069026|Superiority or Other||Mean Difference (Final Values)|0.73|Standard Error of the Mean|0.164|<|0.0001|2-Sided|95.0|0.41|1.06||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially [day 1, then day 8, then day 85] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.|||
1667451|NCT01424813|3069041|Superiority or Other||Mean Difference (Final Values)|1.07|Standard Error of the Mean|0.198|<|0.0001|2-Sided|95.0|0.68|1.46||To adjust for multiplicity, so that the overall alpha level for all tests was controlled at the 0.05 level, tests were done sequentially [day 1, then day 8, then day 85] and terminated if individual results were not significant at the 0.05 level.|mixed model repeated measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.|||
1667452|NCT01424813|3069042|Superiority or Other||Mean Difference (Final Values)|0.83|Standard Error of the Mean|0.128|<|0.0001|2-Sided|95.0|0.57|1.08||Significance at the 0.05 level.|mixed-model repeated-measures (MMRM)|Fixed effects- pooled center, treatment group, study day, and study day by drug interaction, with baseline measured at each study day as covariate.|||
1667453|NCT01424670|3069043|Superiority||Relative Ratio of Probability|0.991||||0.8951|2-Sided|95.0|0.872|1.127|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with treatment success at Month 30.|
1667454|NCT01424670|3069044|Superiority|||||||0.9397|||||||ANCOVA|||Statistical analysis for Month 6.|
1667455|NCT01424670|3069044|Superiority|||||||0.2333|||||||ANCOVA|||Statistical analysis for Week 24.|
1667456|NCT01424670|3069044|Superiority|||||||0.269|||||||ANCOVA|||Statistical analysis for Week 3.|
1667457|NCT01424670|3069044|Superiority|||||||0.807|||||||ANCOVA|||Statistical analysis for Week 2.|
1667458|NCT01424670|3069044|Superiority|||||||0.6825|||||||ANCOVA|||Statistical analysis for Week 1.|
1667459|NCT01424670|3069045|Superiority||Mean Difference (Final Values)|-0.3||||0.6986|2-Sided|95.0|-1.9|1.3|||ANCOVA|||Statistical comparison of mean AUC of change from Baseline.|
1667460|NCT01424670|3069047|Superiority||Relative Ratio of Probability|0.965||||0.5269|2-Sided|95.0|0.869|1.073|||Cochran-Mantel-Haenszel|||Statistical comparison of proportions with favorable treatment outcomes assessed by the Principal Investigator.|
1667461|NCT01424670|3069048|Superiority||Relative Ratio of Probability|0.991||||0.8951|2-Sided|95.0|0.872|1.127|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 30.|
1667462|NCT01424670|3069048|Superiority||Relative Ratio of Probability|0.97||||0.6164|2-Sided|95.0|0.864|1.089|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 24.|
1667463|NCT01424670|3069048|Superiority||Relative Ratio of Probability|0.969||||0.5945|2-Sided|95.0|0.866|1.084|||Cochran-Mantel-Haenszel|||Statistical comparison of proportion with sustained SCC at Month 18.|
1667464|NCT01424670|3069049|Superiority|For testing the homogeneity of proportions, 2 samples were compared using the stratified Cochran-Mantel-Haenszel test.|Ratio of Probability|1.017||||0.7131|2-Sided|95.0|0.927|1.115|||Cochran-Mantel-Haenszel||The stratified Cochran-Mantel-Haenszel test statistics were used for estimation.|Statistical comparison of proportion of participants with SCC at 6 months.|
1667465|NCT01424670|3069049|Superiority|For testing the homogeneity of proportions, 2 samples were compared using the stratified Cochran-Mantel-Haenszel test.|Ratio of Probability|1.096||||0.3818|2-Sided|95.0|0.889|1.352|||Cochran-Mantel-Haenszel||The stratified Cochran-Mantel-Haenszel test statistics were used for estimation.|Statistical comparison of proportion of participants with SCC at 2 months.|
1667466|NCT01424670|3069050|Superiority|||||||0.0562||||||For testing the null hypothesis, the distribution of the time to SCC within the 6-month Intensive Period were compared between the 2 treatment groups using the stratified modified Peto-Peto modification of Gehan’s Wilcoxon rank sum test.|Modified Peto-Peto test|||Comparison of distributions of time to SCC using the MGIT culture system during the 6-month (26-week) Intensive Period.|
1667467|NCT01424644|3069054|Non-Inferiority or Equivalence|The immune response to PRN antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the 95% CI of the difference [(MenACWY-CRM+Tdap+HPV) minus(Placebo+Tdap + HPV)] was greater than 0.5, at 1 month after vaccination.|Vaccine group ratio-Geometric mean conc|0.82|||||2-Sided|95.0|0.72|0.93||||||Non-inferiority of anti-PRN immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.|
1667695|NCT01421459|3069385|Superiority or Other|||||||0.296||||||P-value is for ITSQ Total Score at 12 weeks.|ANCOVA||||
1667468|NCT01424644|3069054|Non-Inferiority or Equivalence|The immune response to FHA antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the 95% CI of the difference [(MenACWY-CRM +Tdap+HPV) minus(Placebo+Tdap + HPV)] was greater than 0.5, at 1 month after Tdap vaccination.|Vaccine group ratio- Geometric mean conc|0.84|||||2-Sided|95.0|0.76|0.93||||||Non-inferiority of anti-FHA immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.|
1667469|NCT01424644|3069054|Non-Inferiority or Equivalence|The immune response to PT antigen for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of the Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the ratio of the GMCs of the MenACWY-CRM +Tdap+HPV group to the Placebo+Tdap + HPV group was greater than 0.5, at 1 month after Tdap vaccination.|Vaccine group ratio-Geometric mean conc|1.01|||||2-Sided|95.0|0.89|1.14||||||Non-inferiority of anti-PT immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.|
1667470|NCT01424644|3069055|Non-Inferiority or Equivalence|The immune response to tetanus toxin for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the difference in seroprotection rates [(MenACWY-CRM+ Tdap+HPV) minus (Placebo+Tdap + HPV)] was greater than -10%, at 1 month after Tdap vaccination.|Vaccine group difference|0.0|||||2-Sided|95.0|-2.0|2.0||||||Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.|
1667471|NCT01424644|3069055|Non-Inferiority or Equivalence|The immune response to diphtheria toxin for the MenACWY-CRM+Tdap+HPV group was considered non-inferior to that of the Placebo+Tdap+HPV group if the lower limit of the two-sided 95% CI of the difference in seroprotection rates [(MenACWY-CRM+Tdap+HPV) minus (Placebo+Tdap + HPV)] was greater than -10%, at 1 month after Tdap vaccination|Vaccine group difference|13.0|||||2-Sided|95.0|9.0|17.0||||||Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo|
1667472|NCT01424566|3069066|Superiority||Mean Difference (Final Values)|-0.02||||0.9173|2-Sided|95.0|-0.42|0.38|||ANCOVA||||
1667473|NCT01424514|3069076|Superiority or Other||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.22|||2-Sided|95.0|-0.15|0.73||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in Maximum TOSS|
1667474|NCT01424514|3069076|Superiority or Other||Mean Difference (Final Values)|0.26|Standard Error of the Mean|0.3|||2-Sided|95.0|-0.34|0.86||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in Maximum TOSS|
1667475|NCT01424514|3069076|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.24|||2-Sided|95.0|-0.3|0.68||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in Maximum TOSS|
1667476|NCT01424514|3069076|Superiority or Other||Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.21|||2-Sided|95.0|-0.22|0.63||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in WM 0-60 TOSS|
1667477|NCT01424514|3069076|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.21|||2-Sided|95.0|-0.32|0.53||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in WM 0-60 TOSS|
1667478|NCT01424514|3069076|Superiority or Other||Mean Difference (Final Values)|0.27|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.06|0.6||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in WM 0-60 TOSS|
1667479|NCT01424514|3069077|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.36|0.26||||||Placebo vs SB-705498 12 mg for Day 14 in AR|
1667480|NCT01424514|3069078|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.031|||2-Sided|95.0|-0.04|0.08||||||Placebo vs SB-705498 12 mg for Day 14, 25 h in AR|
1667481|NCT01424514|3069078|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.027|||2-Sided|95.0|-0.13|-0.02||||||Placebo vs SB-705498 12 mg for Day 14, 2 h in AR|
1667482|NCT01424514|3069078|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.026|||2-Sided|95.0|-0.03|0.07||||||Placebo vs SB-705498 12 mg for Day 1, 2 h in AR|
1667483|NCT01424514|3069079|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.09|||2-Sided|95.0|-0.2|0.16||||||Placebo vs SB-705498 12 mg for Day 1, 24 h in Maximum sneezing|
1667484|NCT01424514|3069079|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.07|||2-Sided|95.0|-0.15|0.13||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in Maximum sneezing|
1667485|NCT01424514|3069079|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.1|||2-Sided|95.0|-0.28|0.14||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in Maximum sneezing|
1667486|NCT01424514|3069079|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.08|||2-Sided|95.0|-0.2|0.11||||||Placebo vs SB-705498 12 mg for Day 14, 24 h in WM 0-60 sneezing|
1667487|NCT01424514|3069079|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.05|||2-Sided|95.0|-0.13|0.09||||||Placebo vs SB-705498 12 mg for Day 14, 1 h in WM 0-60 sneezing|
1667488|NCT01424514|3069079|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.05|||2-Sided|95.0|-0.14|0.08||||||Placebo vs SB-705498 12 mg for Day 1, 1 h in WM 0-60 sneezing|
1667489|NCT01424514|3069083|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.24|||2-Sided|95.0|-0.39|0.57||||||Placebo vs SB-705498 12 mg for Maximum TSS|
1667490|NCT01424514|3069083|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.21|||2-Sided|95.0|-0.3|0.54||||||Placebo vs SB-705498 12 mg for WM 0-60 TSS|
1667491|NCT01424514|3069085|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.3|||2-Sided|95.0|-0.51|0.72||||||Placebo vs SB-705498 12 mg for 24 h in Maximum TSS|
1667492|NCT01424514|3069085|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.27|||2-Sided|95.0|-0.58|0.51||||||Placebo vs SB-705498 12 mg for 1 h in Maximum TSS|
1667493|NCT01424514|3069085|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.24|||2-Sided|95.0|-0.45|0.51||||||Placebo vs SB-705498 12 mg for 24 h in WM 0-60 TSS|
1667494|NCT01424514|3069085|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.24|||2-Sided|95.0|-0.6|0.36||||||Placebo vs SB-705498 12 mg for 1 h in WM 0-60 TSS|
1667495|NCT01424397|3069119|Superiority or Other||Mean Difference (Net)|0.15|Standard Error of the Mean|0.13|||2-Sided|90.0|-0.06|0.37|||||||
1667500|NCT01424397|3069120|Superiority or Other||Mean Difference (Net)|72.4|Standard Error of the Mean|14.567|||2-Sided|90.0|48.28|96.52||||||Placebo versus SB-705498 + FP 12 mg, Nasal Airflow resistance Total WM, 0-4 hr|
1667501|NCT01424397|3069120|Superiority or Other||Mean Difference (Net)|-7.31|Standard Error of the Mean|19.548|||2-Sided|90.0|-39.7|25.05||||||Placebo versus FP 12 mg SB-705498 , Nasal Airflow resistance Total WM, 0-4 hr|
1667502|NCT01424397|3069120|Superiority or Other||Mean Difference (Net)|81.35|Standard Error of the Mean|12.56|||2-Sided|90.0|60.54|102.15||||||Placebo versus FP 200 μg,Nasal Airflow resistance Total WM,0-4 hr|
1667503|NCT01424397|3069122|Superiority or Other||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 + FP compared to FP alone using Mixed Models Analysis was 0.0160
1667504|NCT01424397|3069122|Superiority or Other||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 + FP compared to Placebo using Mixed Models Analysis was 1.0000
1667505|NCT01424397|3069122|Superiority or Other||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with SB-705498 alone compared to Placebo using Mixed Models Analysis was 0.7127
1667506|NCT01424397|3069122|Superiority or Other||||||||||||||||||Bayesian analysis: The posterior probability of a reduction in TNSS with FP alone compared to Placebo using Mixed Models Analysis was 1.0000
1667507|NCT01424306|3069123|Other|RM-ANOVA||||||0.52||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA||||
1667508|NCT01424306|3069124|Other|RM-ANOVA||||||0.056||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA||||
1667509|NCT01424306|3069125|Other|RM-ANOVA||||||0.149||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA||||
1667510|NCT01424306|3069126|Other|RM-ANOVA||||||0.492||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA||||
1667511|NCT01424306|3069127|Other|RM-ANOVA||||||0.596||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA||||
1667512|NCT01424306|3069128|Other|RM-ANOVA||||||0.476||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA||||
1667513|NCT01424306|3069129|Other|RM-ANOVA||||||0.387||||||P-value reflects overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA||||
1667514|NCT01424306|3069130|Other|RM-ANOVA||||||0.366||||||P-value reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA||||
1667515|NCT01424306|3069131|Other|RM-ANOVA|||||<|0.001||||||P-value reflects an overall comparison of the 3 dietary phases by RM-ANOVA|Repeated measures ANOVA||||
1667516|NCT01424306|3069132|Other|RM-ANOVA||||||0.88||||||Reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA||||
1667517|NCT01424306|3069133|Other|RM-ANOVA||||||0.196||||||P-diet: reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA||||
1667518|NCT01424306|3069134|Other|RM-ANOVA||||||0.933||||||P-diet: reflects an overall comparison of the 3 dietary phases by RM-ANOVA|RM-ANOVA||||
1667519|NCT01424306|3069135|Other|||||||0.403||||||P value for the time x diet interaction reflects overall comparison of 3 dietary phases by RM-ANOVA|RM-ANOVA|||RM-ANOVA|
1667520|NCT01424228|3069152|Superiority or Other|||||||0.367|||||||Cochran-Mantel-Haenszel||||
1667521|NCT01424189|3069157|Non-Inferiority or Equivalence|With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCNVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This estimate was based on an assumed standard deviation for UCNVA of 0.16 logMAR units and a 1-sided, α=0.05 test.|Mean Difference (Final Values)|-0.044|Standard Error of the Mean|0.015|||1-Sided|95.0||-0.017|||||||
1667522|NCT01424189|3069158|Non-Inferiority or Equivalence|With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCDVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This was based on an assumed standard deviation for UCDVA of 0.16 logMAR units and a 1-sided, α=0.05 test.|Mean Difference (Final Values)|0.001|Standard Error of the Mean|0.013|||1-Sided|95.0||0.03|||||||
1667523|NCT01424072|3069160|Superiority or Other|||||||0.029|||||||ANOVA|It was carried out the analysis of variance (ANOVA) among the groups at the follow up and then it was used the post hoc test.||Coping Strategy: Confrontation domain|
1667524|NCT01424072|3069160|Superiority or Other|||||||0.039||||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|||It was carried out the analysis of variance (ANOVA) among the groups at the follow up (after 75 days). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.|
1667525|NCT01424072|3069161|Superiority or Other||||||,|0||||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|This result was only to the domain Social Support.||It was carried out the analysis of variance (ANOVA) among the groups in the 3rd assessment (after 60 days) and at the follow up (after 75 days). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.|
1667526|NCT01424072|3069162|Superiority or Other|||||||0.023||||||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|||The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.|
1667527|NCT01423604|3069201|Superiority or Other|||||||0.0236|||||||Pearson’s chi-square test||||
1667528|NCT01423604|3069203|Superiority or Other||Efron approximation of hazard ratio|0.75||||0.134|2-Sided|95.0|0.513|1.094||Two-sided p-value.|Cox proportional hazards model||||
1667529|NCT01423604|3069204|Superiority or Other||Hazard Ratio (HR)|0.502||||0.0081|2-Sided|95.0|0.281|0.888||One-sided p-value.|Log Rank|||Cox Regression Analysis of Overall Survival: C-reactive protein (CRP) > 13 μg/ml; Statistical analysis plan (SAP) specified subgroup analysis|
1667530|NCT01423604|3069204|Superiority or Other||Hazard Ratio (HR)|0.733||||0.0494|2-Sided|95.0|0.506|1.061||One-sided p-value.|Log Rank||||
1667696|NCT01421459|3069385|Superiority or Other|||||||0.393||||||P-value is for ITSQ Total Score at 4 weeks.|ANCOVA||||
1667531|NCT01423084|3069218|Non-Inferiority or Equivalence|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of ELISA GMCs against vaccine antigen 287-953 if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.83|||||2-Sided|95.0|0.67|1.02||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs|
1667532|NCT01423084|3069226|Non-Inferiority or Equivalence|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against NZ 98/254 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.81|||||2-Sided|95.0|0.6|1.09||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against NZ98/254 strain|
1667533|NCT01423084|3069226|Non-Inferiority or Equivalence|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against 5/99 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination ) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|0.92|||||2-Sided|95.0|0.77|1.1||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against 5/99 strain|
1667534|NCT01423084|3069226|Non-Inferiority or Equivalence|Two different lots of rMenB+OMV NZ are to be considered equivalent in terms of hSBA GMTs against H44/76 strain if the two sided 95% Confidence Interval (CI) between groups GMTs ratio at day 31 (ie, one month after the second vaccination) does not exceed the range 0.5 (lower limit) - 2.0 (higher limit).|between groups ratio|1.0|||||2-Sided|95.0|0.82|1.23||||||Equivalence of 2 different lots of rMenB+OMV NZ in terms of hSBA GMTs against H44/76 strain|
1667535|NCT01422889|3069229|Superiority or Other||percentage|2.6|||||1-Sided|||||||||2.6% (27/1054) of ION Registry subjects experienced ARC ST Definite/Probable related to the ION stent at 2 years.|
1667536|NCT01422889|3069230|Superiority or Other||percentage|2.2|||||2-Sided|||||||||2.2% (23/1028) of ION Registry subjects experienced CD/MI related to the ION stent at 12 months|
1667537|NCT01422876|3069231|Superiority or Other||Odds Ratio (OR)|4.303|||<|0.0001|2-Sided|95.0|2.462|7.522|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.|
1667538|NCT01422876|3069231|Superiority or Other||Odds Ratio (OR)|3.065|||<|0.0001|2-Sided|95.0|1.768|5.314|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.|
1667539|NCT01422876|3069231|Superiority or Other||Odds Ratio (OR)|2.961|||<|0.0001|2-Sided|95.0|1.697|5.169|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.|
1667540|NCT01422876|3069231|Superiority or Other||Odds Ratio (OR)|1.893|||<|0.0224|2-Sided|95.0|1.095|3.274|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.|
1667541|NCT01422876|3069232|Superiority or Other||Odds Ratio (OR)|2.795||||0.0005|2-Sided|95.0|1.562|5.001|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.|
1667542|NCT01422876|3069232|Superiority or Other||Odds Ratio (OR)|3.495|||<|0.0001|2-Sided|95.0|1.92|6.363|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.|
1667543|NCT01422876|3069232|Superiority or Other||Odds Ratio (OR)|4.5|||<|0.0001|2-Sided|95.0|2.474|8.184|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.|
1667544|NCT01422876|3069232|Superiority or Other||Odds Ratio (OR)|4.191|||<|0.0001|2-Sided|95.0|2.319|7.573|||Regression, Logistic|||Logistic regression includes treatment, baseline eGFR (MDRD), geographical region and baseline HbA1c.|
1667545|NCT01422876|3069233|Superiority or Other||Mean Difference (Net)|-1.96|Standard Error of the Mean|0.51||0.0001|2-Sided|95.0|-2.97|-0.95|||ANCOVA|||Model for Week 24 includes baseline weight (p<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).|
1667546|NCT01422876|3069233|Superiority or Other||Mean Difference (Net)|-1.22|Standard Error of the Mean|0.51||0.0178|2-Sided|95.0|-2.23|-0.21|||ANCOVA|||Model for Week 24 includes baseline weight (p<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).|
1667547|NCT01422876|3069233|Superiority or Other||Mean Difference (Net)|-0.47|Standard Error of the Mean|0.51||0.3616|2-Sided|95.0|-1.48|0.54||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).|
1667548|NCT01422876|3069233|Superiority or Other||Mean Difference (Net)|0.13|Standard Error of the Mean|0.51||0.801|2-Sided|95.0|-0.88|1.14||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p<0.0001), baseline HbA1c (p=0.0023) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0316), geographical region (p=0.0134), treatment (p=0.0031) as fixed effect(s).|
1667549|NCT01422876|3069234|Superiority or Other||Mean Difference (Net)|-0.57|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.76|-0.37|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p<0.0001) as fixed effect(s).|
1667550|NCT01422876|3069234|Superiority or Other||Mean Difference (Net)|-0.41|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.61|-0.22|||Cochran-Mantel-Haenszel|||Model for Week 24 includes baseline HbA1c (p<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p<0.0001) as fixed effect(s).|
1667551|NCT01422876|3069234|Superiority or Other||Mean Difference (Net)|-0.41|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.61|-0.21|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p<0.0001) as fixed effect(s).|
1667552|NCT01422876|3069234|Superiority or Other||Mean Difference (Net)|-0.14|Standard Error of the Mean|0.1|<|0.1785|2-Sided|95.0|-0.33|0.06|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.8627), geographical region (p=0.0008), treatment (p<0.0001) as fixed effect(s).|
1668915|NCT01400932|3071291|Superiority or Other||||||<|0.001||||||Week 12; IL|ANCOVA||||
1667553|NCT01422876|3069235|Superiority or Other||Mean Difference (Net)|-1.91|Standard Error of the Mean|0.44|<|0.0001|2-Sided|95.0|-2.77|-1.05|||ANCOVA|||Model for Week 24 includes baseline weight (p<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p<0.0001) as fixed effect(s).|
1667554|NCT01422876|3069235|Superiority or Other||Mean Difference (Net)|-0.07|Standard Error of the Mean|0.43|<|0.8757|2-Sided|95.0|-0.91|0.77||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p<0.0001) as fixed effect(s).|
1667555|NCT01422876|3069235|Superiority or Other||Mean Difference (Net)|-2.3|Standard Error of the Mean|0.44|<|0.0001|2-Sided|95.0|-3.15|-1.44|||ANCOVA|||Model for Week 24 includes baseline weight (p<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p<0.0001) as fixed effect(s).|
1667556|NCT01422876|3069235|Superiority or Other||Mean Difference (Net)|0.19|Standard Error of the Mean|0.43|<|0.6604|2-Sided|95.0|-0.65|1.03||Not an alpha protected test.|ANCOVA|||Model for Week 24 includes baseline weight (p<0.0001), baseline HbA1c (p=0.1610) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0162), treatment (p<0.0001) as fixed effect(s).|
1667557|NCT01422876|3069236|Superiority or Other||Mean Difference (Net)|-22.29|Standard Error of the Mean|3.77|<|0.0001|2-Sided|95.0|-29.71|-14.88|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p<0.0001) as fixed effect(s).|
1667558|NCT01422876|3069236|Superiority or Other||Mean Difference (Net)|-23.63|Standard Error of the Mean|3.78|<|0.0001|2-Sided|95.0|-31.06|-16.21|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p<0.0001) as fixed effect(s).|
1667559|NCT01422876|3069236|Superiority or Other||Mean Difference (Net)|-5.82|Standard Error of the Mean|3.78|<|0.1246|2-Sided|95.0|-13.25|1.61|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p<0.0001) as fixed effect(s).|
1667560|NCT01422876|3069236|Superiority or Other||Mean Difference (Net)|-5.31|Standard Error of the Mean|3.78|<|0.1605|2-Sided|95.0|-12.74|2.11|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p<0.0001), baseline HbA1c (p=0.4591) as linear covariate(s) and baseline eGFR (MDRD) (p=0.7413), geographical region (p=0.1504), treatment (p<0.0001) as fixed effect(s).|
1667561|NCT01422876|3069237|Superiority or Other||Mean Difference (Net)|-19.12|Standard Error of the Mean|3.61|<|0.0001|2-Sided|95.0|-26.21|-12.03|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p<0.0001) as fixed effect(s).|
1667562|NCT01422876|3069237|Superiority or Other||Mean Difference (Net)|-11.34|Standard Error of the Mean|3.55|<|0.0015|2-Sided|95.0|-18.31|-4.37|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p<0.0001) as fixed effect(s).|
1667563|NCT01422876|3069237|Superiority or Other||Mean Difference (Net)|-22.2|Standard Error of the Mean|3.62|<|0.0001|2-Sided|95.0|-29.3|-15.1|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p<0.0001) as fixed effect(s).|
1667564|NCT01422876|3069237|Superiority or Other||Mean Difference (Net)|-16.43|Standard Error of the Mean|3.54|<|0.0001|2-Sided|95.0|-23.37|-9.48|||ANCOVA|||Model for Week 24 includes baseline fasting plasma glucose (p<0.0001), baseline HbA1c (p=0.6082) as linear covariate(s) and baseline eGFR (MDRD) (p=0.3685), geographical region (p=0.0104), treatment (p<0.0001) as fixed effect(s).|
1667565|NCT01422876|3069238|Superiority or Other||Mean Difference (Net)|-0.39|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.56|-0.21|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p<0.0001), treatment (p<0.0001) as fixed effect(s).|
1667566|NCT01422876|3069238|Superiority or Other||Mean Difference (Net)|-0.42|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.59|-0.25|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p<0.0001), treatment (p<0.0001) as fixed effect(s).|
1667567|NCT01422876|3069238|Superiority or Other||Mean Difference (Net)|-0.5|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.67|-0.32|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p<0.0001), treatment (p<0.0001) as fixed effect(s).|
1667568|NCT01422876|3069238|Superiority or Other||Mean Difference (Net)|-0.58|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.75|-0.41|||ANCOVA|||Model for Week 24 includes baseline HbA1c (p<0.0001) as linear covariate(s) and baseline eGFR (MDRD) (p=0.0038), geographical region (p<0.0001), treatment (p<0.0001) as fixed effect(s).|
1667569|NCT01422408|3069256|Other|||||||0.1187||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667570|NCT01422408|3069257|Other|||||||0.2011||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667571|NCT01422408|3069258|Other|||||||0.08531||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667572|NCT01422408|3069259|Other|||||||0.6023||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667573|NCT01422408|3069260|Other|||||||0.3676||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667574|NCT01422408|3069261|Other|||||||0.507||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667575|NCT01422408|3069262|Other|||||||0.9106||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667576|NCT01422408|3069263|Other|||||||0.4937||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667577|NCT01422408|3069264|Other|||||||0.7983||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667578|NCT01422408|3069265|Other|||||||0.8833||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667579|NCT01422408|3069266|Other|||||||0.5113||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667580|NCT01422408|3069267|Other|||||||0.9618||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667581|NCT01422408|3069268|Other|||||||0.7395||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667582|NCT01422408|3069269|Other|||||||0.8772||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667583|NCT01422408|3069270|Other|||||||0.6587||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667584|NCT01422408|3069271|Other|||||||0.6023||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667585|NCT01422408|3069272|Other|||||||0.3676||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667586|NCT01422408|3069273|Other|||||||0.507||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667587|NCT01422408|3069274|Other|||||||0.2472||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667588|NCT01422408|3069275|Other|||||||0.2678||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667589|NCT01422408|3069276|Other|||||||0.1029||||||No adjustment for multiple comparison. Significance level of 0.05. Since this endpoint is of an exploratory nature and the significance is well above the threshold, not much more consideration was given to the issue of multiple comparisons|ANOVA|Kruskal-Wallis ANOVA rather than ANOVA since normal distribution of residuals may be suspect.||In order to compare the response between groups, Kruskal-Wallis ANOVA was used.|
1667590|NCT01422408|3069278|Other|2.5% significance level to account for two co-primary endpoints.||||||0.002|||||||Wilcoxon (Mann-Whitney)|||The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.|
1667591|NCT01422408|3069279|Other|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.||||||0.001|||||||Wilcoxon (Mann-Whitney)|||The secondary endpoints (i.e., change in symptoms of vaginal itching from the baseline to 4 weeks, and change in vaginal index score from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.|
1667592|NCT01422408|3069280|Other|Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.|Odds Ratio (OR)|0.0||||0.062|2-Sided|95.0|0.0|1.09||Since there are two-co-primary endpoints, the significance level is 2.5%|McNemar|||"GEE (general estimating equations) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2"|
1667593|NCT01422408|3069280|Other|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.||||||0.002||||||2.5% significance level to account for two co-primary endpoints.|Wilcoxon (Mann-Whitney)|||The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.|
1667594|NCT01422408|3069281|Other|Exact McNemar's test was used to test if the proportion of severe symptoms at baseline are equal to the proportion of severe symptoms at the end of the study.|Odds Ratio (OR)|0.0||||0.001|2-Sided|95.0|0.0|0.36||Since there are two-co-primary endpoints, the significance level is 2.5%|McNemar|||"GEE (general estimating equation) methods were planned as a secondary analysis of the primary endpoints. Missing data for some of the weeks prevented these models from converging and we could not obtain valid results with these methods. Since this is a secondary analysis, we decided to compare symptom severity at baseline vs. week 4 (end of study). Symptoms are considered severe for scores 3 or 4 and not severe for scores 0, 1, 2"|
1667595|NCT01422408|3069281|Other|Two-sided test that the change is different from zero. Not tested against alternative treatment; single arm study.|||||<|0.001||||||2.5% significance level to account for two co-primary endpoints.|Wilcoxon (Mann-Whitney)|||The primary endpoints (i.e., change in symptoms of vaginal dryness from the baseline to 4 weeks, and change in symptoms of dyspareunia from the baseline to 4 weeks) will be analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.|
1667596|NCT01422304|3069287|Superiority or Other (legacy)||Risk Difference (%)|-1.6|||||2-Sided|95.0|-6.3|3.1|||||Risk difference (%) = Sugammadex incidence - Usual Care incidence||
1667597|NCT01422304|3069288|Superiority or Other (legacy)||Mean Difference (Final Values)|1.4|||||2-Sided|95.0|-0.4|3.1|||||Difference is Sugammadex versus Usual Care. A positive value indicates that the average adjusted reduction in Hgb at Visit 3 (bleeding index) was lower in the sugammadex treatment group.|Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy), investigational site and baseline hemoglobin value.|
1667598|NCT01422304|3069289|Superiority or Other (legacy)||GMR|1.1|||||2-Sided|95.0|0.98|1.24|||||GMR is Sugammadex versus Usual Care|Generalized Linear Model was applied to transfusion volume transformed to the log-scale, adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site. Result and 95% Confidence Interval was transformed back to the original scale.|
1667599|NCT01422304|3069290|Superiority or Other (legacy)||Risk Difference (%)|-2.7|||||2-Sided|95.0|-7.4|2.0|||||Risk difference (%) = Sugammadex incidence - Usual Care incidence, adjusted for strata and investigational site|Miettinen and Nurminen Method was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site|
1667600|NCT01422304|3069291|Superiority or Other (legacy)||Mean Difference (Final Values)|-7.2|||||2-Sided|95.0|-45.0|30.5|||||Difference is Sugammadex versus Usual Care. A negative value indicates that the average adjusted drainage volume was lower in the sugammadex treatment group.|Generalized Linear Model was adjusted for strata (renal function and use of prophylactic antithrombotic therapy) and investigational site.|
1667601|NCT01422304|3069293|Superiority or Other (legacy)||Risk Difference (%)|0.3|||||2-Sided|95.0|-0.7|1.5|||||Risk difference (%) = Sugammadex incidence - Usual Care incidence||
1667602|NCT01422304|3069294|Superiority or Other (legacy)||Risk Difference (%)|-0.9|||||2-Sided|95.0|-3.1|1.2|||||Risk difference (%) = Sugammadex incidence - Usual Care incidence||
1667603|NCT01422304|3069295|Superiority or Other (legacy)||Risk Difference (%)|-1.4|||||2-Sided|95.0|-3.4|0.5|||||Risk difference (%) = Sugammadex incidence - Usual Care incidence||
1667604|NCT01422304|3069296|Superiority or Other (legacy)||Risk Difference (%)|-0.6|||||2-Sided|95.0|-3.0|1.8|||||Risk difference (%) = Sugammadex incidence - Usual Care incidence||
1667697|NCT01421459|3069385|Superiority or Other|||||||0.531||||||P-value is for Insulin Delivery Device at Endpoint, up to 24 weeks.|ANCOVA||||
1667698|NCT01421459|3069385|Superiority or Other|||||||0.456||||||P-value is for Insulin Delivery Device at 12 weeks.|ANCOVA||||
1668916|NCT01400932|3071291|Superiority or Other||||||<|0.001||||||Week 8; IL|ANCOVA||||
1667605|NCT01422304|3069297|Superiority or Other (legacy)||GMR (%)|0.9|||||2-Sided|95.0|-1.0|2.9|||||Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = [GMR – 1]*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance < or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.|
1667606|NCT01422304|3069297|Superiority or Other (legacy)||GMR (%)|3.0|||||2-Sided|95.0|1.3|4.7|||||Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of PT(INR) values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = [GMR – 1]*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance < or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.|
1667607|NCT01422304|3069298|Superiority or Other (legacy)||GMR (%)|0.9||||||95.0|-0.9|2.8|||||Estimate of difference in Sugammadex versus Usual Care change from baseline at 60 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = [GMR – 1]*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance < or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.|
1667608|NCT01422304|3069298|Superiority or Other (legacy)||Geometric Mean Ratio (GMR) (%)|5.5|||||2-Sided|95.0|3.7|7.3|||||Estimate of difference in Sugammadex versus Usual Care change from baseline at 10 minutes post dose calculated with log of aPTT values as dependent variable. Results transformed back to GMR of respective changes (expressed as %, = [GMR – 1]*100).|Model was restricted to have no difference between treatment groups for baseline assessment, and was adjusted for center, usual care group (active reversal or spontaneous recovery), renal function (estimated creatinine clearance < or ≥ 60 mL/min), prophylactic antithrombotic therapy (including LMWH, including UFH, or not including either LMWH or UFH), type of hip/knee surgical procedure, and the interaction of time by treatment.|
1667609|NCT01422304|3069299|Superiority or Other (legacy)||Risk Ratio (RR)|0.7|||||2-Sided|95.0|0.38|1.29|||||Relative risk is Sugammadex versus Usual Care|Cochran-Mantel-Haenszel method was stratified for renal function (estimated creatinine clearance < or ≥ 60 mL/min) and prophylactic antithrombotic therapy (including low molecular weight heparin [LMWH], including unfractionated heparin [UFH], or not including either LMWH or UFH)|
1667610|NCT01422213|3069305|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.068||0.0246|2-Sided|95.0|0.02|0.29||No adjustment for multiplicity was made.|ANCOVA||||
1667611|NCT01422213|3069305|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.068||0.0007|2-Sided|95.0|0.1|0.36||No adjustment for multiplicity was made.|ANCOVA||||
1667612|NCT01422213|3069306|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.059||0.0393|2-Sided|95.0|0.01|0.24||No adjustment for multiplicity was made.|ANCOVA||||
1667613|NCT01422213|3069307|Superiority or Other||Odds Ratio (OR)|3.13|||<|0.0001|2-Sided|95.0|1.95|5.03||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic||||
1667614|NCT01422213|3069307|Superiority or Other||Odds Ratio (OR)|2.09|||<|0.003|2-Sided|95.0|1.29|3.41||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic||||
1667615|NCT01422213|3069308|Superiority or Other||Odds Ratio (OR)|3.43|||<|0.0001|2-Sided|95.0|2.26|5.21||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic||||
1667616|NCT01422213|3069308|Superiority or Other||Odds Ratio (OR)|2.19|||<|0.0002|2-Sided|95.0|1.44|3.33||Wald's Test. No adjustment for multiplicity was made.|Regression, Logistic||||
1667617|NCT01422213|3069309|Superiority or Other||Mean Difference (Final Values)|-0.86|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-1.06|-0.65||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-I Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site and treatment-by-visit interaction.|
1667618|NCT01422213|3069309|Superiority or Other||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-0.81|-0.4||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-I Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site and treatment-by-visit interaction.|
1667619|NCT01422213|3069310|Superiority or Other||Mean Difference (Final Values)|-0.85|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-1.08|-0.62||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-S Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667620|NCT01422213|3069310|Superiority or Other||Mean Difference (Final Values)|-0.65|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.88|-0.42||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CGI-S Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667621|NCT01422213|3069311|Superiority or Other||Mean Difference (Final Values)|-6.7|Standard Error of the Mean|0.88|<|0.0001|2-Sided|95.0|-8.43|-4.98||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the MADRS Total Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667699|NCT01421459|3069385|Superiority or Other|||||||0.088||||||P-value is for Insulin Deliver Device at 4 weeks.|ANCOVA||||
1667700|NCT01421459|3069385|Superiority or Other|||||||0.754||||||P-value is for Glycemic Control at Endpoint, up to 24 weeks.|ANCOVA||||
1667622|NCT01422213|3069311|Superiority or Other||Mean Difference (Final Values)|-4.7|Standard Error of the Mean|0.89|<|0.0001|2-Sided|95.0|-6.45|-2.96||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the MADRS Total Score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667623|NCT01422213|3069312|Superiority or Other||Mean Difference (Final Values)|-0.008|Standard Error of the Mean|0.009||0.3549|2-Sided|95.0|-0.03|0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CRT (Attention) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667624|NCT01422213|3069312|Superiority or Other||Mean Difference (Final Values)|-0.032|Standard Error of the Mean|0.009||0.0005|2-Sided|95.0|-0.05|-0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the CRT (Attention) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667625|NCT01422213|3069313|Superiority or Other||Mean Difference (Final Values)|-0.029|Standard Error of the Mean|0.012||0.0157|2-Sided|95.0|-0.05|-0.01||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the SRT (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667626|NCT01422213|3069313|Superiority or Other||Mean Difference (Final Values)|-0.046|Standard Error of the Mean|0.012||0.0002|2-Sided|95.0|-0.07|-0.02||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the SRT (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667627|NCT01422213|3069314|Superiority or Other||Mean Difference (Final Values)|-6.52|Standard Error of the Mean|2.02||0.0013|2-Sided|95.0|-10.49|-2.54||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Incongruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667628|NCT01422213|3069314|Superiority or Other||Mean Difference (Final Values)|-6.75|Standard Error of the Mean|2.04||0.001|2-Sided|95.0|-10.76|-2.74||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Incongruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667629|NCT01422213|3069315|Superiority or Other||Mean Difference (Final Values)|-4.45|Standard Error of the Mean|1.26||0.0005|2-Sided|95.0|-6.93|-1.97||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Congruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667630|NCT01422213|3069315|Superiority or Other||Mean Difference (Final Values)|-4.0|Standard Error of the Mean|1.28||0.0018|2-Sided|95.0|-6.5|-1.49||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the Congruent STROOP Time to Complete (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667631|NCT01422213|3069316|Superiority or Other||Mean Difference (Final Values)|-9.01|Standard Error of the Mean|2.7||0.0009|2-Sided|95.0|-14.32|-3.7||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT B (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667632|NCT01422213|3069316|Superiority or Other||Mean Difference (Final Values)|-7.57|Standard Error of the Mean|2.73||0.0058|2-Sided|95.0|-12.93|-2.2||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT B (Executive Function) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667633|NCT01422213|3069317|Superiority or Other||Mean Difference (Final Values)|-3.8|Standard Error of the Mean|1.35||0.0052|2-Sided|95.0|-6.46|-1.14||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT A (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667634|NCT01422213|3069317|Superiority or Other||Mean Difference (Final Values)|-3.76|Standard Error of the Mean|1.37||0.0061|2-Sided|95.0|-6.45|-1.08||No adjustment for multiplicity was made.|Mixed Models Analysis|||Based on the FAS, the TMT A (Speed of Processing) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667635|NCT01422213|3069318|Superiority or Other||Mean Difference (Final Values)|0.65|Standard Error of the Mean|0.24||0.0073|2-Sided|95.0|0.17|1.12||Since the p-value for RAVLT acquisition for 20 mg was >0.025, the p-value for this test is nominal.|Mixed Models Analysis|||Based on the FAS, the RAVLT (delayed recall) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667636|NCT01422213|3069318|Superiority or Other||Mean Difference (Final Values)|0.71|Standard Error of the Mean|0.24||0.0033|2-Sided|95.0|0.24|1.19||Since the p-value for RAVLT acquisition for 10 mg was >0.025, the p-value for this test is nominal.|Mixed Models Analysis|||Based on the FAS, the RAVLT (delayed recall) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667701|NCT01421459|3069385|Superiority or Other|||||||0.109||||||P-value is for Glycemic Control at 12 weeks.|ANCOVA||||
1667637|NCT01422213|3069319|Superiority or Other||Mean Difference (Final Values)|0.59|Standard Error of the Mean|0.46||0.1988|2-Sided|95.0|-0.31|1.5||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the RAVLT (acquisition) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667638|NCT01422213|3069319|Superiority or Other||Mean Difference (Final Values)|1.02|Standard Error of the Mean|0.46||0.0287|2-Sided|95.0|0.11|1.93||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the RAVLT (acquisition) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667639|NCT01422213|3069320|Superiority or Other||Mean Difference (Final Values)|4.26|Standard Error of the Mean|0.86|<|0.0001|2-Sided|95.0|2.57|5.94||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the DSST (number of correct symbols) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667640|NCT01422213|3069320|Superiority or Other||Mean Difference (Final Values)|4.2|Standard Error of the Mean|0.87|<|0.0001|2-Sided|95.0|2.5|5.9||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the DSST (number of correct symbols) was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline value, baseline value-by-visit interaction, and treatment-by-visit interaction.|
1667641|NCT01422213|3069321|Superiority or Other||Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.071|<|0.0001|2-Sided|95.0|0.19|0.47||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the composite z-score was analysed using the MMRM with an unstructured covariance structure. The model included terms for grouped site, baseline composite z-score, baseline composite z-score-by-visit interaction, and treatment-by-visit interaction.|
1667642|NCT01422213|3069321|Superiority or Other||Mean Difference (Final Values)|0.363|Standard Error of the Mean|0.072|<|0.0001|2-Sided|95.0|0.22|0.5||To adjust for multiplicity, the 10 and 20 mg doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.05/2 = 0.025.|Mixed Models Analysis|||Based on the FAS, the composite z-score was analysed using the mixed model for repeated measurements (MMRM) with an unstructured covariance structure. The model included terms for grouped site, baseline composite z-score, baseline composite z-score-by-visit interaction, and treatment-by-visit interaction.|
1667643|NCT01422070|3069336|Superiority or Other||Odds Ratio (OR)|0.63|||<|0.05|2-Sided|95.0|0.45|0.88|||generalized estimating equation|Generalized estimating equation adjusts the confidence interval for the correlation of outcomes within-centre.|The fully adjusted multivariable logistic regression analysis showed an OR of 0.63 in favour of the presence of an intermediate care unit in the hospital|The null hypothesis was that hospital mortality of patients admitted to intensive care units with intermediate care unit in the hospital is similar to that of the patients admitted to intensive care units without intermediate care unit in the hospital|
1667644|NCT01421719|3069341|Superiority or Other|||||||0.0087|||||||t-test, 2 sided|||Paired t test comparison of baseline number of urinary leaks per day versus number of leaks per day at 6 month evaluation after treatment.|
1667645|NCT01421589|3069360|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1667646|NCT01421589|3069361|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1667647|NCT01421589|3069362|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1667648|NCT01421589|3069363|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1667649|NCT01421589|3069364|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1667650|NCT01421589|3069365|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1667651|NCT01421589|3069366|Superiority or Other|||||||0.02|||||||Regression, Linear|||Univariate regression analyses was performed to assess the relationship between change in skeletal muscle IGF-1 mRNA expression after 12 weeks treatment with rhGH and change in ViPCr.|
1667652|NCT01421511|3069368|Superiority or Other||Risk Difference (RD)|0.9|||||2-Sided|95.0|-3.2|4.9|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the Day 7 Visit using the method of Miettinen and Nurminen without stratification.|
1667653|NCT01421511|3069369|Superiority or Other||Risk Difference (RD)|1.2|||||2-Sided|95.0|-3.3|5.6|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the 48-72 Hour Visit using the method of Miettinen and Nurminen without stratification.|
1667654|NCT01421511|3069370|Non-Inferiority or Equivalence|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-3.7|||||2-Sided|95.0|-7.7|0.2|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.||
1667702|NCT01421459|3069385|Superiority or Other|||||||0.902||||||P-value is for Glycemic Control at 4 weeks.|ANCOVA||||
1667703|NCT01421459|3069385|Superiority or Other|||||||0.307||||||P-value is for Hypoglycemic Control at Endpoint, up to 24 weeks.|ANCOVA||||
1667655|NCT01421511|3069371|Non-Inferiority or Equivalence|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|0.3|||||2-Sided|95.0|-4.8|5.3|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.||
1667656|NCT01421511|3069372|Non-Inferiority or Equivalence|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the EOT Visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-4.1|||||2-Sided|95.0|-8.8|0.3|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.||
1667657|NCT01421511|3069373|Non-Inferiority or Equivalence|A two-sided 95% CI was calculated for the observed differences in the programmatic clinical response at the EOT visit using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-1.0|||||2-Sided|95.0|-6.1|4.1|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.||
1667658|NCT01421511|3069374|Non-Inferiority or Equivalence|A two-sided 95% CI was calculated for the observed differences in the early clinical response rates at 48 to 72 Hours after the first infusion of study drug using the method of Miettinen and Nurminen without stratification. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10%.|Risk Difference (RD)|2.6|||||2-Sided|95.0|-3.0|8.2|||||Risk difference corresponds to the tedizolid responder rate minus the linezolid responder rate.||
1667659|NCT01421498|3069375|Superiority or Other||Treatment difference|-0.02||||0.786|2-Sided|95.0|-0.15|0.11|||t-test, 2 sided||||
1667660|NCT01421498|3069376|Superiority or Other||Treatment difference|0.24||||0.0007|2-Sided|95.0|0.1|0.38|||t-test, 2 sided||||
1667661|NCT01421459|3069378|Superiority or Other||||||>|0.233||||||P-value is for Overall (Baseline to 24 weeks).|Chi-squared||||
1667662|NCT01421459|3069378|Superiority or Other||||||>|0.874||||||P-value is for Endpoint (LOCF).|Chi-squared||||
1667663|NCT01421459|3069378|Superiority or Other||||||>|0.618||||||P-value is for 24 weeks.|Chi-squared||||
1667664|NCT01421459|3069378|Superiority or Other||||||>|0.999||||||P-value is for 12 weeks.|Chi-squared||||
1667665|NCT01421459|3069378|Superiority or Other||||||>|0.176||||||P-value is for 4 weeks.|Chi-squared||||
1667666|NCT01421459|3069379|Superiority or Other|||||||0.1||||||P-value is for Baseline to 24 weeks (Overall).|Chi-squared||||
1667667|NCT01421459|3069379|Superiority or Other|||||||0.314||||||P-value is for Endpoint, up to 24 weeks.|Chi-squared||||
1667668|NCT01421459|3069379|Superiority or Other|||||||0.179||||||P-value is for 24 weeks.|Chi-squared||||
1667669|NCT01421459|3069379|Superiority or Other|||||||0.882||||||P-value is for 12 weeks.|Chi-squared||||
1667670|NCT01421459|3069379|Superiority or Other|||||||0.047||||||P-value is for 4 weeks.|Chi-squared||||
1667671|NCT01421459|3069379|Superiority or Other|||||||0.285||||||P-value is for Baseline.|Chi-squared||||
1667672|NCT01421459|3069380|Superiority or Other|||||||0.686||||||P-value is for Nocturnal Hypoglycemia with BG ≤70 mg/dL events.|Wilcoxon (Mann-Whitney)||||
1667673|NCT01421459|3069380|Superiority or Other|||||||0.995||||||P-value is for Total Hypoglycemia with BG ≤70 mg/dL events.|Wilcoxon (Mann-Whitney)||||
1667674|NCT01421459|3069381|Superiority or Other|||||||0.462||||||P-value is for Nocturnal Hypoglycemic with BG ≤70 mg/dL events.|Chi-squared||||
1667675|NCT01421459|3069381|Superiority or Other|||||||0.594||||||P-value is for Total Hypoglycemic with BG ≤70 mg/dL events.|Chi-squared||||
1667676|NCT01421459|3069382|Superiority or Other|||||||0.293||||||P-value is for HbA1c ≤6.5% at Endpoint, up to 24 weeks.|Chi-squared||||
1667677|NCT01421459|3069382|Superiority or Other|||||||0.34||||||P-value is for HbA1c <7% at Endpoint, up to 24 weeks.|Chi-squared||||
1667678|NCT01421459|3069382|Superiority or Other|||||||0.174||||||P-value is for HbA1c ≤6.5% at 24 weeks.|Chi-squared||||
1667679|NCT01421459|3069382|Superiority or Other|||||||0.186||||||P-value is for HbA1c <7%% at 24 weeks.|Chi-squared||||
1667680|NCT01421459|3069382|Superiority or Other|||||||0.092||||||P-value is for HbA1c ≤6.5% at 20 weeks.|Chi-squared||||
1667681|NCT01421459|3069382|Superiority or Other|||||||0.218||||||P-value is for HbA1c <7% at 20 weeks.|Chi-squared||||
1667682|NCT01421459|3069382|Superiority or Other|||||||0.261||||||P-value is for HbA1c ≤6.5% at 16 weeks.|Chi-squared||||
1667683|NCT01421459|3069382|Superiority or Other|||||||0.128||||||P-value is for HbA1c <7% at 16 weeks.|Chi-squared||||
1667684|NCT01421459|3069382|Superiority or Other|||||||0.463||||||P-value is for HbA1c ≤6.5% at 12 weeks.|Chi-squared||||
1667685|NCT01421459|3069382|Superiority or Other|||||||0.319||||||P-value is for HbA1c <7% at 12 weeks.|Chi-squared||||
1667686|NCT01421459|3069382|Superiority or Other|||||||0.09||||||P-value is for HbA1c ≤ 6.5% at 8 weeks.|Chi-squared||||
1667687|NCT01421459|3069382|Superiority or Other|||||||0.409||||||P-value is for HbA1c <7% at 8 weeks.|Chi-squared||||
1667688|NCT01421459|3069382|Superiority or Other||||||>|0.999||||||P-value is for HbA1c ≤ 6.5% at 4 weeks.|Chi-squared||||
1667689|NCT01421459|3069382|Superiority or Other||||||>|0.688||||||P-value is for HbA1c <7% at 4 weeks.|Chi-squared||||
1667690|NCT01421459|3069382|Superiority or Other||||||>|0.394||||||P-value is for HbA1c ≤ 6.5% at Baseline.|Chi-squared||||
1667691|NCT01421459|3069382|Superiority or Other||||||>|0.661||||||P-value is for HbA1c <7% at Baseline.|Chi-squared||||
1667692|NCT01421459|3069383|Superiority or Other|||||||0.185||||||P-value is for Insulin Dose at Endpoint, up to 24 weeks.|ANOVA||||
1667693|NCT01421459|3069384|Superiority or Other|||||||0.393|||||||ANCOVA||||
1667694|NCT01421459|3069385|Superiority or Other|||||||0.662||||||P-value is for ITSQ Total Score at Endpoint, up to 24 weeks.|ANCOVA||||
1667718|NCT01421459|3069386|Superiority or Other|||||||0.437||||||P-value is for Behavior domain at Endpoint, up to 24 weeks.|ANCOVA||||
1667719|NCT01421459|3069386|Superiority or Other|||||||0.502||||||P-value is for Behavior domain at 12 weeks.|ANCOVA||||
1667720|NCT01421459|3069386|Superiority or Other|||||||0.726||||||P-value is for Behavior domain at 4 weeks.|ANCOVA||||
1667721|NCT01421459|3069387|Superiority or Other|||||||0.334||||||P-value is for change at Endpoint, up to 24 wks.|ANCOVA||||
1667722|NCT01421459|3069387|Superiority or Other|||||||0.33||||||P-value is for change at 24 wks.|ANCOVA||||
1667723|NCT01421459|3069387|Superiority or Other|||||||0.041||||||P-value is for change at 20 wks.|ANCOVA||||
1667724|NCT01421459|3069387|Superiority or Other|||||||0.089||||||P-value is for change at 16 wks.|ANCOVA||||
1667725|NCT01421459|3069387|Superiority or Other|||||||0.368||||||P-value is for change at 12 wks.|ANCOVA||||
1667726|NCT01421459|3069387|Superiority or Other|||||||0.323||||||P-value is for change at 8 wks.|ANCOVA||||
1667727|NCT01421459|3069387|Superiority or Other|||||||0.036||||||P-value is for change at 4 wks.|ANCOVA||||
1667728|NCT01421459|3069387|Superiority or Other|||||||0.687||||||P-value is for Baseline.|ANCOVA||||
1667729|NCT01421459|3069388|Superiority or Other|||||||0.788||||||P-value is for Endpoint, up to 24 weeks.|ANCOVA||||
1667730|NCT01421459|3069388|Superiority or Other|||||||0.779||||||P-value is for Baseline.|ANCOVA||||
1667731|NCT01421459|3069389|Superiority or Other|||||||0.878||||||P-value is for 0300 hrs at Endpoint, up to 24 weeks.|ANCOVA||||
1667732|NCT01421459|3069389|Superiority or Other|||||||0.537||||||P-value is for Bed Time at Endpoint, up to 24 weeks.|ANCOVA||||
1667733|NCT01421459|3069389|Superiority or Other|||||||0.485||||||P-value is for Evening Pre-Meal at Endpoint, up to 24 weeks.|ANCOVA||||
1667734|NCT01421459|3069389|Superiority or Other|||||||0.366||||||P-value is for Midday 2 hrs PP Meal at Endpoint, up to 24 weeks.|ANCOVA||||
1667735|NCT01421459|3069389|Superiority or Other|||||||0.04||||||P-value is for Midday Pre-Meal at Endpoint, up to 24 weeks.|ANCOVA||||
1667736|NCT01421459|3069389|Superiority or Other|||||||0.05||||||P-value is for Morning 2 hrs PP Meal at Endpoint, up to 24 weeks.|ANCOVA||||
1667737|NCT01421459|3069389|Superiority or Other|||||||0.265||||||P-value is for Morning Pre-Meal at Endpoint, up to 24 wk.|ANCOVA||||
1667738|NCT01421459|3069389|Superiority or Other|||||||0.543||||||P-value is for 0300 hrs at Baseline.|ANCOVA||||
1667739|NCT01421459|3069389|Superiority or Other|||||||0.725||||||P-value is for Bed Time at Baseline.|ANCOVA||||
1667740|NCT01421459|3069389|Superiority or Other|||||||0.161||||||P-value is for Evening Pre-Meal at Baseline.|ANCOVA||||
1667741|NCT01421459|3069389|Superiority or Other|||||||0.258||||||P-value is for Midday 2 hrs PP Meal at Baseline.|ANCOVA||||
1667742|NCT01421459|3069389|Superiority or Other|||||||0.107||||||P-value is for Midday Pre-Meal at Baseline|ANCOVA||||
1667743|NCT01421459|3069389|Superiority or Other|||||||0.62||||||P-value is for Morning 2 hrs PP Meal at Baseline.|ANCOVA||||
1667744|NCT01421459|3069389|Superiority or Other|||||||0.837||||||P-value is at Morning Pre-Meal at Baseline.|ANCOVA||||
1667745|NCT01421459|3069390|Superiority or Other|||||||0.097||||||P-value is for 24 weeks.|ANCOVA||||
1667746|NCT01421459|3069390|Superiority or Other|||||||0.161||||||P-value is for 20 weeks.|ANCOVA||||
1667747|NCT01421459|3069390|Superiority or Other|||||||0.345||||||P-value is for 16 weeks.|ANCOVA||||
1667748|NCT01421459|3069390|Superiority or Other|||||||0.869||||||P-value is for 12 weeks.|ANCOVA||||
1667749|NCT01421459|3069390|Superiority or Other|||||||0.91||||||P-value is for 8 weeks.|ANCOVA||||
1667750|NCT01421459|3069390|Superiority or Other|||||||0.382||||||P-value is for 4 weeks.|ANCOVA||||
1667751|NCT01421459|3069392|Non-Inferiority or Equivalence|The primary treatment comparison was to compare LY2963016 versus Lantus at the non-inferiority margin of +0.4%. If the upper limit of the 95% confidence interval on the change from baseline to 24-week endpoint HbA1c for LY2963016 versus Lantus was below +0.4%, then LY2963016 would be declared non-inferior to Lantus.|Mean Difference (Final Values)|0.052||||0.403|2-Sided|95.0|-0.07|0.175|||ANCOVA||||
1667752|NCT01421342|3069394|Superiority||Odds Ratio (OR)|1.37||||0.043|2-Sided|95.0|1.01|1.86||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.|Regression, Logistic||Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR||
1667753|NCT01421342|3069394|Superiority||Odds Ratio (OR)|1.7|||<|0.001|2-Sided|95.0|1.26|2.29|||Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.|
1667754|NCT01421342|3069394|Superiority||Odds Ratio (OR)|1.26|||<|0.11|2-Sided|95.0|0.95|1.68||After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion||
1667755|NCT01421342|3069395|Superiority||Odds Ratio (OR)|1.55||||0.002|2-Sided|95.0|1.17|2.05||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR||
1667756|NCT01421342|3069395|Superiority||Odds Ratio (OR)|1.74|||<|0.0001|2-Sided|95.0|1.33|2.29|||Regression, Logistic|Stratified by participating medical center (site)|Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.|
1667757|NCT01421342|3069395|Superiority||Odds Ratio (OR)|1.16|||<|0.28|2-Sided|95.0|0.89|1.5|||Regression, Logistic|Stratified by participating medical center|Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion|After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.|
1667758|NCT01421342|3069396|Superiority||Hazard Ratio (HR)|0.96||||0.87|2-Sided|95.0|0.58|1.59|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR||
1667759|NCT01421342|3069396|Superiority||Hazard Ratio (HR)|1.12||||0.68|2-Sided|95.0|0.65|1.94|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR||
1667760|NCT01421342|3069396|Superiority||Hazard Ratio (HR)|1.36||||0.7|2-Sided|95.0|0.78|2.39|||Log Rank||Represents relative odds of relapse for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR||
1667761|NCT01421342|3069397|Superiority||Odds Ratio (OR)|1.11||||0.46|2-Sided|95.0|0.84|1.48||Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR was evaluated at the 0.05 significance level.|Regression, Logistic||Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR|If either if the first two hypothesis tests for the co-primary hypotheses were significant, perform the test of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.|
1667762|NCT01421342|3069397|Superiority||Odds Ratio (OR)|1.42||||0.018|2-Sided|95.0|1.06|1.89||Co-primary hypothesis: Second ordered test after ordering largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR|Co-primary hypothesis: After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.|
1667763|NCT01421342|3069397|Superiority||Odds Ratio (OR)|1.31||||0.076|2-Sided|95.0|0.97|1.75||Co-primary hypothesis: After ordering results from largest p-value to smallest (Hochberg approach) the comparison of Augmenting Antidepressant+Bupropion with Switching to Bupropion-SR was performed at the 0.05 significance level.|Regression, Logistic|Stratified by participating medical center|Represents relative odds of remission for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR||
1667764|NCT01421225|3069426|Equivalence|The null hypothesis was that the number of hours would be the same (no effect of control).|Mean Difference (Final Values)|2.2||||0.12|2-Sided|||||Statistical analysis was performed using a paired t-test.|t-test, 2 sided|||We tested the number of nighttime (10 PM - 8 AM) hours glucose was in the target range (110-200 mg/dL) on each of the two nights for which the patient was followed (one night under Standard Insulin Pump Therapy; one night under Closed-loop Insulin Therapy)|
1667765|NCT01421147|3069427|Superiority or Other|||||||0.25||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.|Wilcoxon (Mann-Whitney)||||
1667766|NCT01421147|3069427|Superiority or Other|||||||0.826||||||P-value is for Severe Events-52 wk.|Wilcoxon (Mann-Whitney)||||
1667767|NCT01421147|3069427|Superiority or Other|||||||0.738||||||P-value is for Total Events with BG ≤70 mg/dL, if available-52 wk.|Wilcoxon (Mann-Whitney)||||
1667768|NCT01421147|3069427|Superiority or Other|||||||0.669||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.|Wilcoxon (Mann-Whitney)||||
1667769|NCT01421147|3069427|Superiority or Other|||||||0.163||||||P-value is for Severe Events-24 wk.|Wilcoxon (Mann-Whitney)||||
1667770|NCT01421147|3069427|Superiority or Other|||||||0.717||||||P-value is for Total Events with BG ≤70 mg/dL, if available-24 wk.|Wilcoxon (Mann-Whitney)||||
1667771|NCT01421147|3069428|Superiority or Other|||||||0.606||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-52 wk.|Fisher Exact||||
1667772|NCT01421147|3069428|Superiority or Other|||||||0.661||||||P-value is for Nocturnal Events with BG ≤70 mg/dL-24 wk.|Fisher Exact||||
1667773|NCT01421147|3069428|Superiority or Other|||||||0.828||||||P-value is for Severe Events-52 wk.|Fisher Exact||||
1667774|NCT01421147|3069428|Superiority or Other|||||||0.174||||||P-value is for Severe Events-24 wk.|Fisher Exact||||
1667775|NCT01421147|3069428|Superiority or Other|||||||0.495||||||P-value is for Total Events with BG ≤70 mg/dL,if available-52-wk.|Fisher Exact||||
1667776|NCT01421147|3069428|Superiority or Other|||||||0.703||||||P-value is for Total Events with BG ≤70 mg/dL,if available-24 wk.|Fisher Exact||||
1667777|NCT01421147|3069429|Superiority or Other|||||||0.54||||||P-value is for HbA1c- Endpoint, up to 52 weeks ≤6.5%.|Fisher Exact||||
1667778|NCT01421147|3069429|Superiority or Other|||||||0.209||||||P-value is for HbA1c- Endpoint, up to 52 weeks <7.0%.|Fisher Exact||||
1667779|NCT01421147|3069429|Superiority or Other|||||||0.661||||||P-value is for HbA1c- Endpoint, up to 24 weeks ≤6.5%.|Fisher Exact||||
1667780|NCT01421147|3069429|Superiority or Other|||||||0.646||||||P-value is for HbA1c- Endpoint, up to 24 weeks <7.0%.|Fisher Exact||||
1667781|NCT01421147|3069429|Superiority or Other|||||||0.9||||||P-value is for HbA1c- at 52 weeks ≤6.5%.|Fisher Exact||||
1667782|NCT01421147|3069429|Superiority or Other|||||||0.551||||||P-value is for HbA1c- at 52 weeks <7.0%.|Fisher Exact||||
1667783|NCT01421147|3069429|Superiority or Other|||||||0.408||||||P-value is for HbA1c- at 36 weeks ≤6.5%.|Fisher Exact||||
1667784|NCT01421147|3069429|Superiority or Other|||||||0.385||||||P-value is for HbA1c- at 36 weeks <7.0%.|Fisher Exact||||
1667785|NCT01421147|3069429|Superiority or Other|||||||0.824||||||P-value is for HbA1c- at 24 weeks ≤6.5%.|Fisher Exact||||
1667786|NCT01421147|3069429|Superiority or Other|||||||0.926||||||P-value is for HbA1c- at 24 weeks <7.0%.|Fisher Exact||||
1667787|NCT01421147|3069429|Superiority or Other|||||||0.17||||||P-value is for HbA1c- at 12 weeks ≤6.5%.|Fisher Exact||||
1667788|NCT01421147|3069429|Superiority or Other|||||||0.398||||||P-value is for HbA1c- at 12 weeks <7.0%.|Fisher Exact||||
1667789|NCT01421147|3069429|Superiority or Other|||||||0.053||||||P-value is for HbA1c- at 6 weeks ≤6.5%.|Fisher Exact||||
1667790|NCT01421147|3069429|Superiority or Other|||||||0.012||||||P-value is for HbA1c- at 6 weeks <7.0%.|Fisher Exact||||
1667791|NCT01421147|3069429|Superiority or Other|||||||0.606||||||P-value is for HbA1c- at Baseline ≤6.5%.|Fisher Exact||||
1667792|NCT01421147|3069429|Superiority or Other|||||||0.015||||||P-value is for HbA1c- at Baseline <7.0 %.|Fisher Exact||||
1667793|NCT01421147|3069430|Superiority or Other||LS Mean Difference|2.8||||0.188|2-Sided|95.0|-1.37|6.971||P-value is for Endpoint, up to 52 wk-Total Insulin.|ANCOVA||||
1667794|NCT01421147|3069430|Superiority or Other||LS Mean Difference|0.702||||0.617|2-Sided|95.0|-2.058|3.462||P-value is for Endpoint, up to 52 wk-Bolus Insulin.|ANCOVA||||
1667795|NCT01421147|3069430|Superiority or Other||LS Mean Difference|2.059||||0.072|2-Sided|95.0|-0.187|4.305||P-value is for Endpoint, up to 52 wk-Basal Insulin.|ANCOVA||||
1667796|NCT01421147|3069430|Superiority or Other||LS Mean Difference|2.964||||0.151|2-Sided|95.0|-1.081|7.01||P-value is for Endpoint, up to 24 wk-Total Insulin.|ANCOVA||||
1667797|NCT01421147|3069430|Superiority or Other||LS Mean Difference|1.267||||0.374|2-Sided|95.0|-1.531|4.065||P-value is for Endpoint, up to 24 wk-Bolus Insulin.|ANCOVA||||
1667798|NCT01421147|3069430|Superiority or Other||LS Mean Difference|1.724||||0.096|2-Sided|95.0|-0.308|3.755||P-value is for Endpoint, up to 24 wk-Basal Insulin.|ANCOVA||||
1667799|NCT01421147|3069431|Superiority or Other||LS Mean Difference|0.017||||0.45|2-Sided|95.0|-0.028|0.062||P-value is for Endpoint, up to 52 wk-Total Insulin.|ANCOVA||||
1667800|NCT01421147|3069431|Superiority or Other||LS Mean Difference|-0.001||||0.957|2-Sided|95.0|-0.034|0.032||P-value is for Endpoint, up to 52 wk-Bolus Insulin.|ANCOVA||||
1667801|NCT01421147|3069431|Superiority or Other||LS Mean Difference|0.018||||0.159|2-Sided|95.0|-0.007|0.042||P-value is for Endpoint, up to 52 wk-Basal Insulin.|ANCOVA||||
1667802|NCT01421147|3069431|Superiority or Other||LS Mean Difference|0.019||||0.377|2-Sided|95.0|-0.023|0.062||P-value is for Endpoint, up to 24 wk-Total Insulin.|ANCOVA||||
1667803|NCT01421147|3069431|Superiority or Other||LS Mean Difference|0.006||||0.726|2-Sided|95.0|-0.026|0.038||P-value is for Endpoint, up to 24 wk-Bolus Insulin.|ANCOVA||||
1667804|NCT01421147|3069431|Superiority or Other||LS Mean Difference|0.014||||0.235|2-Sided|95.0|-0.009|0.036||P-value is for Endpoint, up to 24 wk-Basal Insulin.|ANCOVA||||
1667805|NCT01421147|3069432|Superiority or Other||LS Mean Difference|-0.54||||0.685|2-Sided|95.0|-3.15|2.07||P-value is for ITSQ Total-Endpoint, up to 52 weeks.|ANCOVA||||
1667806|NCT01421147|3069432|Superiority or Other||LS Mean Difference|0.23||||0.862|2-Sided|95.0|-2.33|2.78||P-value is for ITSQ Total-24 weeks.|ANCOVA||||
1667807|NCT01421147|3069432|Superiority or Other||LS Mean Difference|-0.59||||0.676|2-Sided|95.0|-3.36|2.18||P-value is for ITSQ Total-Baseline.|ANCOVA||||
1667808|NCT01421147|3069432|Superiority or Other||LS Mean Difference|-0.29||||0.845|2-Sided|95.0|-3.16|2.59||P-value is for IDD-Endpoint, up to 52 weeks.|ANCOVA||||
1667809|NCT01421147|3069432|Superiority or Other||LS Mean Difference|0.41||||0.786|2-Sided|95.0|-2.54|3.35||P-value is for IDD-24 weeks.|ANCOVA||||
1667810|NCT01421147|3069432|Superiority or Other||LS Mean Difference|-1.53||||0.367|2-Sided|95.0|-4.85|1.8||P-value is for IDD-Baseline.|ANCOVA||||
1667811|NCT01421147|3069432|Superiority or Other||LS Mean Difference|-1.26||||0.422|2-Sided|95.0|-4.34|1.82||P-value is for HC-Endpoint, up to 52 weeks.|ANCOVA||||
1667812|NCT01421147|3069432|Superiority or Other||LS Mean Difference|-1.03||||0.51|2-Sided|95.0|-4.09|2.03||P-value is for HC-24 weeks.|ANCOVA||||
1667813|NCT01421147|3069432|Superiority or Other||LS Mean Difference|-0.61||||0.708|2-Sided|95.0|-3.81|2.59||P-value is for HC-Baseline.|ANCOVA||||
1667814|NCT01421147|3069432|Superiority or Other||LS Mean Difference|0.91||||0.609|2-Sided|95.0|-2.59|4.41||P-value is for GC-Endpoint, up to 52 weeks.|ANCOVA||||
1667815|NCT01421147|3069432|Superiority or Other||LS Mean Difference|1.25||||0.463|2-Sided|95.0|-2.1|4.61||P-value is for GC-24 weeks.|ANCOVA||||
1667816|NCT01421147|3069432|Superiority or Other||LS Mean Difference|0.09||||0.961|2-Sided|95.0|-3.62|3.81||P-value is for GC-Baseline.|ANCOVA||||
1667817|NCT01421147|3069432|Superiority or Other||LS Mean Difference|-0.91||||0.645|2-Sided|95.0|-4.79|2.97||P-value is for LF-Endpoint, up to 52 weeks.|ANCOVA||||
1667818|NCT01421147|3069432|Superiority or Other||LS Mean Difference|0.84||||0.673|2-Sided|95.0|-3.08|4.77||P-value is for LF-24 weeks.|ANCOVA||||
1667819|NCT01421147|3069432|Superiority or Other||LS Mean Difference|0.82||||0.694|2-Sided|95.0|-3.26|4.89||P-value is for LF-Baseline.|ANCOVA||||
1667820|NCT01421147|3069432|Superiority or Other||LS Mean Difference|-0.94||||0.582|2-Sided|95.0|-4.29|2.41||P-value is for IR-Endpoint, up to 52 weeks.|ANCOVA||||
1667821|NCT01421147|3069432|Superiority or Other||LS Mean Difference|0.56||||0.744|2-Sided|95.0|-2.79|3.9||P-value is for IR-24 weeks.|ANCOVA||||
1667822|NCT01421147|3069432|Superiority or Other||LS Mean Difference|-0.77||||0.681|2-Sided|95.0|-4.42|2.89||P-value is for IR-Baseline.|ANCOVA||||
1667823|NCT01421147|3069433|Superiority or Other||LS Mean Difference|0.25||||0.824||95.0|-1.92|2.41||P-value is for Endpoint, up to 52 weeks-Worry TS.|ANCOVA||||
1667824|NCT01421147|3069433|Superiority or Other||LS Mean Difference|1.12||||0.323|2-Sided|95.0|-1.1|3.34||P-value is for 24 weeks-Worry TS.|ANCOVA||||
1667825|NCT01421147|3069433|Superiority or Other||LS Mean Difference|1.21||||0.304||95.0|-1.1|3.51||P-value is for Baseline-Worry TS.|ANCOVA||||
1667826|NCT01421147|3069433|Superiority or Other||LS Mean Difference|0.16||||0.804|2-Sided|95.0|-1.12|1.45||P-value is for Endpoint, up to 52 weeks-Behavior TS.|ANCOVA||||
1667827|NCT01421147|3069433|Superiority or Other||LS Mean Difference|0.2||||0.778|2-Sided|95.0|-1.16|1.55||P-value is for 24 weeks-Behavior TS|ANCOVA||||
1667828|NCT01421147|3069433|Superiority or Other||LS Mean Difference|0.64||||0.401|2-Sided|95.0|-0.86|2.15||P-value is for Baseline-Behavior TS.|ANCOVA||||
1667829|NCT01421147|3069434|Superiority or Other||LS Mean Difference|0.34||||0.253|2-Sided|95.0|-0.25|0.93||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA||||
1668917|NCT01400932|3071291|Superiority or Other||||||<|0.001||||||Week 4; IL|ANCOVA||||
1667830|NCT01421147|3069434|Superiority or Other||LS Mean Difference|0.24||||0.32|2-Sided|95.0|-0.23|0.71||P-value is for change at Endpoint, up to 24 weeks.|ANCOVA||||
1667831|NCT01421147|3069434|Superiority or Other||LS Mean Difference|0.17||||0.435|2-Sided|95.0|-0.25|0.59||P-value is for change at 18 weeks.|ANCOVA||||
1667832|NCT01421147|3069434|Superiority or Other||LS Mean Difference|0.11||||0.541|2-Sided|95.0|-0.25|0.47||P-value is for change at 12 weeks.|ANCOVA||||
1667833|NCT01421147|3069434|Superiority or Other||LS Mean Difference|0.03||||0.823|2-Sided|95.0|-0.23|0.29||P-value is for change at 6 weeks.|ANCOVA||||
1667834|NCT01421147|3069435|Superiority or Other||LS Mean Difference|-0.26||||0.06|2-Sided|95.0|-0.53|0.01||P-value is for Endpoint, up to 52 weeks.|ANCOVA||||
1667835|NCT01421147|3069435|Superiority or Other||LS Mean Difference|-0.04||||0.781|2-Sided|95.0|-0.33|0.25||P-value is for Endpoint, up to 24 weeks.|ANCOVA||||
1667836|NCT01421147|3069435|Superiority or Other||LS Mean Difference|-0.17||||0.32|2-Sided|95.0|-0.52|0.17||P-value is for Baseline.|ANCOVA||||
1667837|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.21||||0.355|2-Sided|95.0|-0.65|0.23||P-vale is for Endpoint, up to 52 wk-0300 hrs.|ANCOVA||||
1667838|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.48||||0.031|2-Sided|95.0|-0.92|-0.04||P-value is for Endpoint, up to 52 wk-Bed Time.|ANCOVA||||
1667839|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.01||||0.955|2-Sided|95.0|-0.44|0.42||P-value is for Endpoint, up to 52 wk-EV Pre-Meal.|ANCOVA||||
1667840|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.13||||0.545|2-Sided|95.0|-0.56|0.3||P-value is for Endpoint, up to 52 wk-MD 2 hrs PP.|ANCOVA||||
1667841|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.03||||0.866|2-Sided|95.0|-0.43|0.36||P-value is for Endpoint, up to 52 wk-MD Pre-Meal.|ANCOVA||||
1667842|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.32||||0.148|2-Sided|95.0|-0.76|0.11||P-value is for Endpoint, up to 52 wk-AM 2 hrs PP.|ANCOVA||||
1667843|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.26||||0.23|2-Sided|95.0|-0.68|0.16||P-value is for Endpoint, up to 52 wk-AM Pre-Meal.|ANCOVA||||
1667844|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.45||||0.033|2-Sided|95.0|-0.86|-0.04||P-value is for Endpoint, up to 24 wk-0300 hrs.|ANCOVA||||
1667845|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.5||||0.03|2-Sided|95.0|-0.95|-0.05||P-value is for Endpoint, up to 24 wk- Bed Time.|ANCOVA||||
1667846|NCT01421147|3069436|Superiority or Other||LS Mean Difference|0.2||||0.364|2-Sided|95.0|-0.24|0.65||P-value is for Endpoint, up to 24 wk-EV Pre-Meal.|ANCOVA||||
1667847|NCT01421147|3069436|Superiority or Other||LS Mean Difference|0.09||||0.687|2-Sided|95.0|-0.34|0.52||P-value is for Endpoint, up to 24 wk-MD 2 hrs PP.|ANCOVA||||
1667848|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.03||||0.883|2-Sided|95.0|-0.44|0.38||P-value is for Endpoint, up to 24 wk-MD Pre-Meal.|ANCOVA||||
1667849|NCT01421147|3069436|Superiority or Other||LS Mean Difference|0.25||||0.248|2-Sided|95.0|-0.18|0.68||P-value is for Endpoint, up to 24 wk-AM 2 hrs PP.|ANCOVA||||
1667850|NCT01421147|3069436|Superiority or Other||LS Mean Difference|0.17||||0.399|2-Sided|95.0|-0.23|0.58||P-value is for Endpoint, up to 24 wk-AM Pre-Meal.|ANCOVA||||
1667851|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.1||||0.7|2-Sided|95.0|-0.61|0.41||P-value is for Baseline-0300 hrs.|ANCOVA||||
1667852|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.11||||0.693|2-Sided|95.0|-0.66|0.44||P-value is for Baseline-Bed Time.|ANCOVA||||
1667853|NCT01421147|3069436|Superiority or Other||LS Mean Difference|0.05||||0.856|2-Sided|95.0|-0.49|0.58||P-value is for Baseline-EV Pre-Meal.|ANCOVA||||
1667854|NCT01421147|3069436|Superiority or Other||LS Mean Difference|0.31||||0.232|2-Sided|95.0|-0.2|0.82||P-value is for Baseline-MD 2 hrs PP.|ANCOVA||||
1667855|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.28||||0.209|2-Sided|95.0|-0.71|0.16||P-value is for Baseline-MD Pre-Meal.|ANCOVA||||
1667856|NCT01421147|3069436|Superiority or Other||LS Mean Difference|-0.48||||0.066|2-Sided|95.0|-1.0|0.03||P-value is for Baseline-AM 2 hrs PP.|ANCOVA||||
1667857|NCT01421147|3069436|Superiority or Other||LS Mean Difference|0.18||||0.489|2-Sided|95.0|-0.33|0.69||P-value is for Baseline-AM Pre-Meal.|ANCOVA||||
1667858|NCT01421147|3069437|Superiority or Other||LS Mean Difference|0.02||||0.737|2-Sided|95.0|-0.099|0.14||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA||||
1667859|NCT01421147|3069437|Superiority or Other||LS Mean Difference|0.004||||0.948|2-Sided|95.0|-0.119|0.127||P-value is for change at 52 weeks.|ANCOVA||||
1667860|NCT01421147|3069437|Superiority or Other||LS Mean Difference|0.06||||0.314|2-Sided|95.0|-0.057|0.177||P-value is for change at 36 weeks.|ANCOVA||||
1667861|NCT01421147|3069437|Superiority or Other||LS Mean Difference|0.098||||0.08|2-Sided|95.0|-0.012|0.208||P-value is for change at 24 weeks.|ANCOVA||||
1667862|NCT01421147|3069437|Superiority or Other||LS Mean Difference|0.113||||0.03|2-Sided|95.0|0.011|0.215||P-value is for change at 12 weeks.|ANCOVA||||
1667863|NCT01421147|3069437|Superiority or Other||LS Mean Difference|-0.007||||0.86|2-Sided|95.0|-0.087|0.072||P-value is for change at 6 weeks.|ANCOVA||||
1667864|NCT01421147|3069438|Superiority or Other||LS Mean Difference|0.81||||0.131|2-Sided|95.0|-0.25|1.86||P-value is for change at Endpoint, up to 52 weeks.|ANCOVA||||
1667865|NCT01421147|3069438|Superiority or Other||LS Mean Difference|0.37||||0.373|2-Sided|95.0|-0.46|1.21||P-value is for change at Endpoint, up to 24 weeks.|ANCOVA||||
1667866|NCT01421147|3069438|Superiority or Other||LS Mean difference|0.4||||0.32|2-Sided|95.0|-0.4|1.21||P-value is for change at 12 weeks.|ANCOVA||||
1667867|NCT01421147|3069438|Superiority or Other||LS Mean Difference|0.41||||0.205|2-Sided|95.0|-0.23|1.05||P-value is for change at 6 weeks.|ANCOVA||||
1667868|NCT01421147|3069439|Superiority or Other||LS Mean Difference|0.108||||0.055|2-Sided|95.0|-0.002|0.219|||ANCOVA||||
1667869|NCT01421134|3069440|Superiority or Other||Odds Ratio (OR)|4.27|||<|0.0001|2-Sided|95.0|2.105|8.663|||Regression, Logistic||||
1667870|NCT01421134|3069441|Superiority or Other||Odds Ratio (OR)|6.615|||<|0.0001|2-Sided|95.0|3.251|13.459|||Regression, Logistic||Odds Ratio was based on a logistic regression of response, with treatment group, baseline MADRS total score, and pooled center as fixed effects.||
1667871|NCT01421134|3069442|Superiority or Other||Least Square Mean Difference|-4.5|Standard Error of the Mean|0.81|<|0.0001|2-Sided|95.0|-6.1|-2.9|||ANCOVA||||
1667872|NCT01421134|3069443|Superiority or Other||Least Square Mean Difference|-4.8|Standard Error of the Mean|1.21||0.0001|2-Sided|95.0|-7.2|-2.4|||ANCOVA||||
1667873|NCT01421134|3069444|Superiority or Other||Least Square Mean Difference|-2.1|Standard Error of the Mean|0.5|<|0.0001|2-Sided|95.0|-3.1|-1.1|||Mixed Models Analysis||||
1667874|NCT01421134|3069445|Superiority or Other||Least Square Mean Difference|-0.65|Standard Error of the Mean|0.157|<|0.0001|2-Sided|95.0|-0.96|-0.34|||Mixed Models Analysis||||
1667875|NCT01421134|3069446|Superiority or Other||Least Square Mean Difference|-7.5|Standard Error of the Mean|1.37|<|0.0001|2-Sided|95.0|-10.2|-4.8|||Mixed Models Analysis||||
1667876|NCT01420926|3069453|Superiority or Other (legacy)|||||||0.3|||||||Stratified 1-sided log-rank||||
1667877|NCT01420848|3069454|Superiority or Other|||||||0.005||||||After ANOVA, the Post Hoc Test was done and the statistical significance was p<0.05.|ANOVA|||"It was carried out the analysis of variance (ANOVA) of the medium difference among the groups at the follow-up (after 15 days).~Hypothesis: there is at least one difference among the groups (State Anxiety)."|
1667878|NCT01420848|3069454|Superiority or Other|||||||0.012||||||After ANOVA it was performed Post Hoc Test and the statistical significance was p<0.05.|ANOVA|||It was carried out the analysis of variance (ANOVA)of the medium difference among the groups in the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups (State Anxiety)|
1667879|NCT01420848|3069455|Superiority or Other|||||||0.023||||||The statistical significance was p<0.05.|ANOVA|||"It was verified the normality of data distribution and the homogeneity of variance.~It was carried out the analysis of variance (ANOVA) among the groups at the follow-up (after 15 days)."|
1667880|NCT01420848|3069455|Superiority or Other|||||||0.006||||||It was used the Post Hoc and the statistical significance was p<0.05.|ANOVA|||It was carried out the analysis of variance (ANOVA) among the groups at the 3rd (12 sessions) Hypothesis: there is at least one difference among the groups.|
1667881|NCT01420549|3069466|Non-Inferiority|The non-inferiority assessment was analyzed by the bilateral confidence interval (95%) for the ratio of the mean LDLfinal/LDLbaseline of the R/E combination, compared to the mean LDLfinal/LDLbaseline of the S/E combination and the bilateral confidence interval (95%) for the difference between the two means of the percentage variation of LDL-C in the treatments ([(LDLfinal – LDLbaseline)/LDLbaseline))*100)R+E] – [(LDLfinal – LDLbaseline)/LDLbaseline))*100)S+E].|Median Difference (Final Values)|-10.32|Standard Error of the Mean|3.33||0.0013|2-Sided|95.0|-16.94|-3.7|||ANCOVA|Estimates for treatment effect and their 95% confidence intervals were exponentiated to produce estimates of percentage change.|Mean Percentage Change LDL- C (%)|Rosuvastatin + Ezetimibe versus Simvastatin + Ezetimibe|
1667882|NCT01420289|3069469|Superiority or Other||Mean Difference (Final Values)|30.0|Standard Error of the Mean|11.0|<|0.05|2-Sided|95.0|10.0|100.0|||t-test, 2 sided||||
1667883|NCT01420289|3069470|Superiority or Other||Mean Difference (Final Values)|14.0|Standard Error of the Mean|15.0||0.086|2-Sided|95.0|10.0|80.0|||t-test, 2 sided||||
1667884|NCT01420068|3069501|Superiority||Mean Difference (Net)|-1.17||||0.32|2-Sided|95.0|-3.66|1.32||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline BMI as covariates.||Secondary hypertension group (at LT Visit 19 [Week 156])|
1667885|NCT01420068|3069501|Superiority||Mean Difference (Net)|-0.11||||0.86|2-Sided|95.0|-1.29|1.08||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline BMI as covariates||Primary Hypertension group (at LT Visit 18 [Week 104])|
1667886|NCT01420068|3069502|Superiority||Mean Difference (Net)|0.92||||0.67|2-Sided|95.0|-3.74|5.57||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline height as covariates.||Secondary hypertension group (at LT Visit 19 [Week 156])|
1667887|NCT01420068|3069502|Superiority||Mean Difference (Net)|0.62||||0.403|2-Sided|95.0|-0.85|2.09||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline height as covariates||Primary Hypertension group (at LT Visit 18 [Week 104])|
1667888|NCT01420068|3069503|Superiority||Mean Difference (Net)|-3.06||||0.215|2-Sided|95.0|-8.22|2.1||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline weight as covariates.||Secondary hypertension group (at LT Visit 19 [Week 156])|
1667889|NCT01420068|3069503|Superiority||Mean Difference (Net)|0.02||||0.992|2-Sided|95.0|-3.29|3.33||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and Baseline weight as covariates||Primary Hypertension group (at LT Visit 18 [Week 104])|
1667890|NCT01420068|3069505|Superiority||Mean Difference (Net)|0.03||||0.957|2-Sided|95.0|-1.06|1.12||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline BMI as covariates.|||
1667891|NCT01420068|3069506|Superiority||Mean Difference (Net)|0.69||||0.303|2-Sided|95.0|-0.63|2.02||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline height as covariates.|||
1667892|NCT01420068|3069507|Superiority||Mean Difference (Net)|0.31||||0.84|2-Sided|95.0|-2.74|3.37||p-value for statistical significance at 0.05 level for 2-sided superiority testing.|ANCOVA|Treatment regimen, region, age strata, and hypertension etiology (primary, secondary) as factors, and Baseline weight as covariates.|||
1667931|NCT01419314|3069551|Superiority or Other||Mean Difference (Final Values)|-3.23|Standard Error of the Mean|5.27||0.155|2-Sided|95.0|-13.93|7.47||Bonferroni adjustment for significance<0.013.|t-test, 2 sided|df(35)|The statistical power for the between intervention contrast was calculated to be 0.26|Null Hypothesis: There is not difference in pain scores between the liner and splint applications at week three.|
1667987|NCT01416584|3069744|Superiority||Odds Ratio (OR)|0.53||||0.05|2-Sided|95.0|0.28|1.0|||General Estimating Equation (GEE)||||
1667988|NCT01416584|3069744|Superiority or Other||Odds Ratio (OR)|0.75||||0.37|2-Sided|95.0|0.36|1.55|||General Estimating Equation (GEE)||||
1667989|NCT01416584|3069744|Superiority||Odds Ratio (OR)|0.4||||0.01|2-Sided|95.0|0.39|0.4|||General Estimating Equation (GEE)||||
1667893|NCT01420016|3069508|Equivalence|The analysis used a time-by-condition mixed model to estimate the annual rate of change in post-index CV risk values by treatment group. The models included fixed effects for study arm (CDS vs. UC), time (years since index), and study-arm-by-time comparing the rate of change in CDS versus UC and a random clinic intercept. The intervention effect was the difference in rate of change in CDS versus UC clinics, with the study-arm-by-time interaction assessing statistical significance (P<0.05).|Slope Difference (Net)|-2.25|||<|0.05|2-Sided|95.0|-3.45|-1.04||A priori power analysis (power=.80, α2=.05) estimated detectable group difference in CVR at 1 year of ~2-3%, assuming 18 clinics, 1000 patients per clinic (actual 400), 3 CVR per patient (actual 2.3), and ICC=.01-03 (actual .019). p-value calculated.|Mixed Models Analysis||The intervention effect was the difference in annualized rates of change (slope) in CV risk in CDS versus UC clinics, with the study-arm-by-time interaction assessing statistical significance (P<0.05).||
1667894|NCT01419626|3069537|Superiority||Difference in LS mean|-0.024||||0.009|2-Sided|95.0|-0.042|-0.006|||ANCOVA|||Statistical analysis at Week 4|
1667895|NCT01419626|3069537|Superiority||Difference in LS mean|-0.101|||<|0.001|2-Sided|95.0|-0.12|-0.083|||ANCOVA|||Statistical analysis at Week 4|
1667896|NCT01419626|3069537|Superiority||Difference in LS mean|-0.077|||<|0.001|2-Sided|95.0|-0.095|-0.059|||ANCOVA|||Statistical analysis at Week 4|
1667897|NCT01419626|3069537|Superiority||Difference in LS mean|-0.016|||<|0.057|2-Sided|95.0|-0.032|0.0|||ANCOVA|||Statistical analysis at Week 2|
1667898|NCT01419626|3069537|Superiority||Difference in LS mean|-0.083|||<|0.001|2-Sided|95.0|-0.099|-0.066|||ANCOVA|||Statistical analysis at Week 2|
1667899|NCT01419626|3069537|Superiority||Difference in LS mean|-0.067|||<|0.001||95.0|-0.083|-0.05|||ANCOVA|||Statistical analysis at Week 2|
1667900|NCT01419626|3069538|Superiority||Difference in LS mean|-0.015||||0.071|2-Sided|95.0|-0.031|0.001|||ANCOVA|||Statistical analysis at Week 4|
1667901|NCT01419626|3069538|Superiority||Difference in LS mean|-0.034|||<|0.001|2-Sided|95.0|-0.05|-0.018|||ANCOVA|||Statistical analysis at Week 4|
1667902|NCT01419626|3069538|Superiority||Difference in LS mean|-0.019|||<|0.02|2-Sided|95.0|-0.035|-0.003|||ANCOVA|||Statistical analysis at Week 4|
1667903|NCT01419626|3069538|Superiority||Difference in LS mean|-0.009|||<|0.294|2-Sided|95.0|-0.025|0.007|||ANCOVA|||Statistical analysis at Week 2|
1667904|NCT01419626|3069538|Superiority||Difference in LS mean|-0.039|||<|0.001|2-Sided|95.0|-0.055|-0.023|||ANCOVA|||Statistical analysis at Week 2|
1667905|NCT01419626|3069538|Superiority||Difference in LS mean|-0.03|||<|0.001|2-Sided|95.0|-0.046|-0.014|||ANCOVA|||Statistical analysis at Week 2|
1667906|NCT01419626|3069539|Superiority||Difference in LS mean|-0.157|||<|0.001|2-Sided|95.0|-0.265|-0.049|||ANCOVA|||Statistical analysis at Week 2|
1667907|NCT01419626|3069539|Superiority||Difference in LS mean|-0.558|||<|0.001|2-Sided|95.0|-0.667|-0.449|||ANCOVA|||Statistical analysis at Week 2|
1667908|NCT01419626|3069539|Superiority||Difference in LS mean|-0.401|||<|0.001|2-Sided|95.0|-0.51|-0.292|||ANCOVA|||Statistical analysis at Week 2|
1667909|NCT01419626|3069540|Superiority||Difference in LS mean|-0.171||||0.001|2-Sided|95.0|-0.273|-0.069|||ANCOVA|||Statistical analysis at Week 2|
1667910|NCT01419626|3069540|Superiority||Difference in LS mean|-0.534|||<|0.001|2-Sided|95.0|-0.637|-0.431|||ANCOVA|||Statistical analysis at Week 2|
1667911|NCT01419626|3069540|Superiority||Difference in LS mean|-0.362|||<|0.001|2-Sided|95.0|-0.465|-0.259|||ANCOVA|||Statistical analysis at Week 2|
1667912|NCT01419626|3069541|Superiority||Difference in LS mean|-0.107|||<|0.001|2-Sided|95.0|-0.137|-0.077|||ANCOVA|||Statistical analysis at Week 4|
1667913|NCT01419626|3069541|Superiority||Difference in LS mean|-0.257|||<|0.001|2-Sided|95.0|-0.287|-0.226|||ANCOVA|||Statistical analysis at Week 4|
1667914|NCT01419626|3069541|Superiority||Difference in LS mean|-0.15|||<|0.001|2-Sided|95.0|-0.18|-0.12|||ANCOVA|||Statistical analysis at Week 4|
1667915|NCT01419626|3069541|Superiority||Difference in LS mean|-0.073|||<|0.001|2-Sided|95.0|-0.099|-0.048|||ANCOVA|||Statistical analysis at Week 2|
1667916|NCT01419626|3069541|Superiority||Difference in LS mean|-0.164|||<|0.001|2-Sided|95.0|-0.189|-0.138|||ANCOVA|||Statistical analysis at Week 2|
1667917|NCT01419626|3069541|Superiority||Difference in LS mean|-0.09|||<|0.001|2-Sided|95.0|-0.115|-0.065|||ANCOVA|||Statistical analysis at Week 2|
1667918|NCT01419626|3069542|Superiority||Difference in LS mean|-0.053|||<|0.001|2-Sided|95.0|-0.083|-0.023|||ANCOVA|||Statistical analysis at Week 4|
1667919|NCT01419626|3069542|Superiority||Difference in LS mean|-0.144|||<|0.001|2-Sided|95.0|-0.175|-0.114|||ANCOVA|||Statistical analysis at Week 4|
1667920|NCT01419626|3069542|Superiority||Difference in LS mean|-0.091|||<|0.001|2-Sided|95.0|-0.121|-0.061|||ANCOVA|||Statistical analysis at Week 4|
1667921|NCT01419626|3069542|Superiority||Difference in LS mean|-0.004|||<|0.671|2-Sided|95.0|-0.023|0.015|||ANCOVA|||Statistical analysis at Week 2|
1667922|NCT01419626|3069542|Superiority||Difference in LS mean|-0.044|||<|0.001||95.0|-0.064|-0.025|||ANCOVA|||Statistical analysis at Week 2|
1667923|NCT01419626|3069542|Superiority||Difference in LS mean|-0.04|||<|0.001|2-Sided|95.0|-0.059|-0.021|||ANCOVA|||Statistical analysis at Week 2|
1667924|NCT01419626|3069543|Superiority||Difference in LS mean|-0.203||||0.002||95.0|-0.333|-0.074|||ANCOVA|||Statistical analysis at Week 4|
1667925|NCT01419626|3069543|Superiority||Difference in LS mean|-0.697|||<|0.001|2-Sided|95.0|-0.828|-0.567|||ANCOVA|||Statistical analysis at Week 4|
1667926|NCT01419626|3069543|Superiority||Difference in LS mean|-0.494|||<|0.001|2-Sided|95.0|-0.625|-0.363|||ANCOVA|||Statistical analysis at Week 4|
1667927|NCT01419626|3069544|Superiority|Statistical analysis at Week 4|Difference in LS mean|-0.208|||<|0.001|2-Sided|95.0|-0.326|-0.09|||ANCOVA||||
1667928|NCT01419626|3069544|Superiority||Difference in LS mean|-0.669|||<|0.001|2-Sided|95.0|-0.789|-0.549|||ANCOVA|||Statistical analysis at Week 4|
1667929|NCT01419626|3069544|Superiority||Difference in LS mean|-0.461|||<|0.001|2-Sided|95.0|-0.581|-0.341|||ANCOVA|||Statistical analysis at Week 4|
1667930|NCT01419314|3069551|Superiority or Other||Mean Difference (Final Values)|-9.67|Standard Error of the Mean|6.66||0.155|2-Sided|95.0|-23.2|3.85|||t-test, 2 sided|df(35)||Null Hypothesis: There is no difference in pain scores between the liner and splint applications at week six.|
1667976|NCT01416636|3069721|Superiority|||||||0.04|||||||Wilcoxon (Mann-Whitney)||||
1667977|NCT01416636|3069722|Superiority|||||||8e-05|||||||Wilcoxon (Mann-Whitney)||||
1667932|NCT01419314|3069551|Superiority or Other||Mean Difference (Final Values)|16.09|Standard Error of the Mean|3.6|<|0.0005|2-Sided|95.0|8.8|23.39||Bonferroni adjustment for significance<0.013.|t-test, 2 sided||Paired t-test contrasting pain scores from baseline to week six of the trial-Splint group. The statistical power for the within splint intervention contrast was calculated to be 0.99.|Null hypothesis: Is there a difference in baseline pain scores compared to those at week 6 in the splinting group?|
1667933|NCT01419314|3069551|Superiority or Other||Mean Difference (Final Values)|45.19|Standard Deviation|20.25|<|0.001|2-Sided|95.0|38.33|52.05|||ANOVA|Sphericity was not tenable for the factor pain scores, degrees of freedom were corrected using Huynh-Feldt estimates, df (1.71,56.46).||A repeated measure ANOVA was performed to evaluate the contrasts of interest.|
1667934|NCT01419236|3069559|Superiority or Other||LS Mean Difference|-0.03||||0.938|2-Sided|90.0|-0.61|0.55|||Mixed Models Repeated Measure Analysis||||
1667935|NCT01419236|3069560|Superiority or Other||LS Mean Difference|-0.08||||0.885|2-Sided|90.0|-1.03|0.87|||Mixed Models Repeated Measure Analysis||||
1667936|NCT01419236|3069561|Superiority or Other||LS Mean Difference|0.32||||0.473|2-Sided|90.0|-0.41|1.04|||Mixed Models Repeated Measure Analysis||||
1667937|NCT01419236|3069562|Superiority or Other||LS Mean Difference|1.03||||0.172|2-Sided|90.0|-0.22|2.27|||ANCOVA||||
1667938|NCT01419236|3069563|Superiority or Other||LS Mean Difference|0.3||||0.535|2-Sided|90.0|-0.5|1.1|||Mixed Models Repeated Measure Analysis||||
1667939|NCT01419236|3069564|Superiority or Other||LS Mean Difference|0.81||||0.079|2-Sided|90.0|0.05|1.57|||Mixed Models Repeated Measure Analysis||||
1667940|NCT01419236|3069565|Superiority or Other||LS Mean Difference|0.42||||0.342|2-Sided|90.0|-0.31|1.15|||Mixed Models Repeated Measure Analysis||||
1667941|NCT01419236|3069566|Superiority or Other||LS Mean Difference|-0.44||||0.164|2-Sided|90.0|-0.96|0.08|||Mixed Models Repeated Measures Analysis||||
1667942|NCT01419236|3069567|Superiority or Other||LS Mean Difference|0.66||||0.38|2-Sided|90.0|-0.59|1.91|||Mixed Models Repeated Measure Analysis||||
1667943|NCT01419197|3069568|Superiority or Other||Difference in Survival Percentage|11.0||||0.0104|2-Sided|95.0|2.58|19.33||The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood`s method.|z-test|||1-year survival|
1667944|NCT01419197|3069568|Superiority or Other||Difference in Survival Percentage|12.4||||0.0003|2-Sided|95.0|5.67|19.14||The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood`s method.|z-test|||6-month survival|
1667945|NCT01419197|3069569|Superiority or Other||Hazard Ratio (HR)|0.677||||0.0007|2-Sided|95.0|0.539|0.85||The two-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O’Brien-Fleming stopping boundary for this second and final interim analysis was HR<0.748 (p value < 0.012).|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or > 3); and 3) Presence of visceral disease (any visceral disease versus no visceral disease).|
1667946|NCT01419197|3069571|Superiority or Other||Hazard Ratio (HR)|1.115||||0.4952|2-Sided|95.0|0.819|1.517|||Log Rank|||The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or > 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).|
1667947|NCT01419197|3069572|Superiority or Other||Difference in Survival Percentage|11.7||||0.1805|2-Sided|95.0|-5.41|28.75||The p-value for the difference in survival rates was derived from the z-test using the standard errors computed using Greenwood`s method.|z-test|||1-year survival|
1667948|NCT01419197|3069572|Superiority or Other||Difference in Survival Percentage|12.6||||0.0011|2-Sided|95.0|5.03|20.09||The p-value for the difference in survival rate was derived from the z-test using the standard errors computed using Greenwood`s method.|z-test|||6-month survival|
1667949|NCT01419197|3069574|Superiority or Other||Difference in Response Percentage|22.7|||<|0.0001|2-Sided|95.0|16.2|29.2|||Mantel Haenszel|||The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or > 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).|
1667950|NCT01419197|3069575|Superiority or Other||Hazard Ratio (HR)|0.552||||0.0034|2-Sided|95.0|0.369|0.826||The 2-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O’Brien-Fleming stopping boundary for this first OS interim analysis was HR<0.363 (p-value < 0.0000013).|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or > 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).|
1667951|NCT01419197|3069576|Superiority or Other||Hazard Ratio (HR)|0.528|||<|0.0001|2-Sided|95.0|0.422|0.661||The two-sided stratified log-rank test was used to compare progression-free survival between the two treatment arms at the overall two-sided significance level of 0.5%.|Log Rank||The hazard ratio was estimated by Cox regression.|The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or > 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).|
1667952|NCT01418365|3069645|Non-Inferiority or Equivalence|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|0.993|||||2-Sided|90.0|0.951|1.04|||||||
1667953|NCT01418365|3069646|Non-Inferiority or Equivalence|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean ratio|0.979|||||2-Sided|90.0|0.961|0.998|||||||
1667978|NCT01416636|3069723|Superiority|||||||3e-06|||||||Wilcoxon (Mann-Whitney)||||
1667979|NCT01416636|3069724|Superiority|||||||1e-05|||||||Wilcoxon (Mann-Whitney)||||
1667954|NCT01418209|3069647|Superiority or Other|||||||0.03||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo|
1667955|NCT01418209|3069647|Superiority or Other||||||<|0.001||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo.|
1667956|NCT01418209|3069649|Superiority or Other|||||||0.07||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo|
1667957|NCT01418209|3069649|Superiority or Other|||||||0.01||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo|
1667958|NCT01418209|3069651|Superiority or Other|||||||0.005||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||VMS frequency values were log transformed for modeling.|
1667959|NCT01418209|3069651|Superiority or Other||||||<|0.001||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures||VMS frequency values were log transformed for modeling.|
1667960|NCT01418209|3069652|Superiority or Other|||||||0.02||||||p-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold of statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo|
1667961|NCT01418209|3069652|Superiority or Other|||||||0.02||||||P-values from active treatment vs. placebo contrasts in a repeated measures linear model of outcome as a function of treatment arm, clinical site, week, and baseline outcome. The a priori threshold for statistical significance was 0.025.|repeated measures linear model|Robust standard errors were calculated using generalized estimating equations to account for within-participant correlation between repeated measures.||Outcome differences between active treatment and placebo|
1667962|NCT01417481|3069674|Superiority or Other||||||>|0.05|||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.|||
1667963|NCT01417481|3069675|Superiority or Other||||||<|0.01|||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.|||
1667964|NCT01417481|3069676|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|Due to the cross-over, paired analysis was done. The hypothesis was that glycine will improve variables, thus significance was set at one-tail.|||
1667965|NCT01417481|3069677|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.|||
1667966|NCT01417481|3069678|Superiority or Other||||||=|0|||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.|||
1667967|NCT01417481|3069679|Superiority or Other||||||=|0|||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.|||
1667968|NCT01417481|3069680|Superiority or Other||||||=|0|||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.|||
1667969|NCT01417481|3069681|Superiority or Other||||||>|0.05|||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.|||
1667970|NCT01417481|3069682|Superiority or Other||||||>|0.05|||||||t-test, 1 sided|The hypothesis was that glycine will improve inflammatory biomarkers, and thus statistical significance was set at one-tail.|||
1667971|NCT01417481|3069683|Superiority or Other||||||>|0.05|||||||t-test, 1 sided|Due to the cross-over, a paired analysis was done. The hypothesis was that glycine will improve variables, and thus significance was set at one-tail.|||
1667972|NCT01417195|3069695|Non-Inferiority or Equivalence|The pre-defined non-inferiority margin for the lower limit of the 95% CI for the difference in fertilization rate was below -12%.|Mean Difference (Final Values)|3.6|||||2-Sided|95.0|-4.3|11.5|||||"Mean difference = Menopur/Bravelle - Menopur.~95% CI is based on Student's t-distribution, assuming equal variances."||
1667973|NCT01417104|3069702|Superiority or Other||Mean Difference (Net)|2.4||||0.041|2-Sided|95.0|0.44|4.36|||t-test, 2 sided||||
1667974|NCT01417104|3069703|Superiority or Other||Mean Difference (Final Values)|5.16|||<|0.031|2-Sided|95.0|0.85|9.47|||t-test, 2 sided||||
1667975|NCT01416636|3069720|Superiority|||||||0.227|||||||Wilcoxon (Mann-Whitney)||||
1667990|NCT01416584|3069745|Superiority||Odds Ratio (OR)|0.84||||0.63|2-Sided|95.0|0.42|1.69|||General Estimating Equation (GEE)||||
1667991|NCT01416584|3069745|Superiority||Odds Ratio (OR)|0.41||||0.03|2-Sided|95.0|0.39|0.44|||General Estimating Equation (GEE)||||
1667992|NCT01416584|3069745|Superiority||Odds Ratio (OR)|0.35||||0.01|2-Sided|95.0|0.34|0.35|||General Estimating Equation (GEE)||||
1667993|NCT01416584|3069746|Superiority||Odds Ratio (OR)|1.07||||0.85|2-Sided|95.0|0.2|5.66|||General Estimating Equation (GEE)||||
1667994|NCT01416584|3069746|Superiority||Odds Ratio (OR)|0.39||||0.02|2-Sided|95.0|0.38|0.41|||General Estimating Equation (GEE)||||
1667995|NCT01416584|3069746|Superiority||Odds Ratio (OR)|0.37||||0.02|2-Sided|95.0|0.36|0.38|||General Estimating Equation (GEE)||||
1667996|NCT01416584|3069747|Superiority||Odds Ratio (OR)|1.86||||0.1|2-Sided|95.0|1.53|2.26|||General Estimating Equation (GEE)||||
1667997|NCT01416584|3069747|Superiority||Odds Ratio (OR)|0.73||||0.39|2-Sided|95.0|0.34|1.57|||General Estimating Equation (GEE)||||
1667998|NCT01416584|3069747|Superiority||Odds Ratio (OR)|0.39||||0.02|2-Sided|95.0|0.38|0.41|||General Estimating Equation (GEE)||||
1667999|NCT01416584|3069748|Superiority||Odds Ratio (OR)|1.27||||0.64|2-Sided|95.0|0.36|4.46|||General Estimating Equation (GEE)||||
1668000|NCT01416584|3069748|Superiority||Odds Ratio (OR)|1.1||||0.88|2-Sided|95.0|0.32|3.73|||General Estimating Equation (GEE)||||
1668001|NCT01416584|3069748|Superiority||Odds Ratio (OR)|1.4||||0.6|2-Sided|95.0|0.4|4.83|||General Estimating Equation (GEE)||||
1668002|NCT01416389|3069777|Superiority or Other (legacy)|||||||0.365|||||||Chi-squared||||
1668003|NCT01416389|3069779|Superiority or Other (legacy)|||||||0.608|||||||Chi-squared||||
1668004|NCT01416389|3069780|Superiority or Other (legacy)|||||||0.344|||||||t-test, 1 sided|||This measure is compared between two treatment arms using a one-sided t-test. This measure followed a normal distribution.|
1668005|NCT01416194|3069784|Superiority||Hazard Ratio (HR)|0.6||||0.24|2-Sided|95.0|0.3|1.3|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668006|NCT01416194|3069784|Superiority||Hazard Ratio (HR)|0.3|||<|0.01|2-Sided|95.0|0.2|0.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668007|NCT01416194|3069785|Superiority||Hazard Ratio (HR)|0.8||||0.19|2-Sided|95.0|0.6|1.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668008|NCT01416194|3069785|Superiority||Hazard Ratio (HR)|0.8||||0.03|2-Sided|95.0|0.6|1.0|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668009|NCT01416194|3069786|Superiority||Hazard Ratio (HR)|1.1||||0.59|2-Sided|95.0|0.8|1.6|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668010|NCT01416194|3069786|Superiority||Hazard Ratio (HR)|1.2||||0.24|2-Sided|95.0|0.9|1.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668011|NCT01416194|3069788|Superiority||Hazard Ratio (HR)|0.8||||0.38|2-Sided|95.0|0.5|1.4|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668012|NCT01416194|3069788|Superiority||Hazard Ratio (HR)|0.5|||<|0.01|2-Sided|95.0|0.3|0.7|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668013|NCT01416194|3069789|Superiority||Hazard Ratio (HR)|0.4||||0.06|2-Sided|95.0|0.2|1.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668014|NCT01416194|3069789|Superiority||Hazard Ratio (HR)|0.3|||<|0.01|2-Sided|95.0|0.1|0.5|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668015|NCT01416194|3069790|Superiority||Hazard Ratio (HR)|0.6||||0.01|2-Sided|95.0|0.4|0.9|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668016|NCT01416194|3069790|Superiority||Hazard Ratio (HR)|0.4|||<|0.01|2-Sided|95.0|0.3|0.6|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668017|NCT01416194|3069791|Superiority||Hazard Ratio (HR)|0.9||||0.74|2-Sided|95.0|0.7|1.3|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668041|NCT01416181|3069811|Superiority or Other|||||||0.1666|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) & BL 9HPT (non-dominant hand).||NP Group: Week 156|
1668018|NCT01416194|3069791|Superiority||Hazard Ratio (HR)|1.9|||<|0.01|2-Sided|95.0|1.4|2.5|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668019|NCT01416194|3069792|Superiority||Hazard Ratio (HR)|1.0||||0.9|2-Sided|95.0|0.4|2.1|||Regression, Linear|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668020|NCT01416194|3069792|Superiority||Hazard Ratio (HR)|0.4|||<|0.01|2-Sided|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668021|NCT01416194|3069793|Superiority||Hazard Ratio (HR)|0.7||||0.19|2-Sided|95.0|0.4|1.2|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668022|NCT01416194|3069793|Superiority||Hazard Ratio (HR)|0.7||||0.1|2-Sided|95.0|0.5|1.1|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668023|NCT01416194|3069794|Superiority||Hazard Ratio (HR)|0.7||||0.37|2-Sided|95.0|0.4|1.5|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668024|NCT01416194|3069794|Superiority||Hazard Ratio (HR)|0.6||||0.01|2-Sided|95.0|0.3|0.9|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668025|NCT01416194|3069795|Superiority||Hazard Ratio (HR)|1.1||||0.76|2-Sided|95.0|0.5|2.4|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668026|NCT01416194|3069795|Superiority||Hazard Ratio (HR)|0.5|||<|0.01|2-Sided|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668027|NCT01416194|3069796|Superiority||Hazard Ratio (HR)|1.0||||0.91|2-Sided|95.0|0.4|2.2|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668028|NCT01416194|3069796|Superiority||Hazard Ratio (HR)|0.4|||<|0.01|2-Sided|95.0|0.3|0.7|||Regression, Logistic|||The hazard ratio from Cox proportional hazard regression models was used for comparison of event rates of the primary and secondary endpoints in each treatment group. Statistical two-sided tests was used with a significance level of 0.05.|
1668029|NCT01416181|3069798|Superiority or Other||||||<|0.0001||||||p-value for comparison between the active and placebo groups at Week 156 compared to Week 108 is based on negative binomial regression model, adjusted for baseline EDSS (<=5.5 or >=6) and baseline volume of T2 lesions.|negative binomial regression model|natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment||Week 156|
1668030|NCT01416181|3069799|Superiority or Other|||||||0.5034||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active & placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) & BL WGM brain volume||Percentage hange from Baseline to Week 156|
1668031|NCT01416181|3069800|Superiority or Other|||||||0.007||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active & placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) & BL normalized brain volume.||Percentage change from Week 24 to Week 156|
1668032|NCT01416181|3069804|Superiority or Other|||||||0.3465|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (<=5.5 or>=6) and BL SDMT.||Week 156|
1668033|NCT01416181|3069806|Superiority or Other|||||||0.7084|||||||ANCOVA|p-value for comparison between active & placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) & BL MSIS-29 physical score.|||
1668034|NCT01416181|3069808|Superiority or Other|||||||0.8066|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) & BL 6MWT.||Week 156|
1668035|NCT01416181|3069809|Superiority or Other|||||||0.2594|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||NP Group: Week 156|
1668036|NCT01416181|3069809|Superiority or Other|||||||0.9121|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||CP Group: Week 156|
1668037|NCT01416181|3069809|Superiority or Other|||||||0.7225|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||Overall: Week 156|
1668038|NCT01416181|3069810|Superiority or Other|||||||0.3861|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||NP Group: Week 156|
1668039|NCT01416181|3069810|Superiority or Other|||||||0.7122|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||CP Group: Week 156|
1668040|NCT01416181|3069810|Superiority or Other|||||||0.433|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6).||Overall: Week 156|
1668042|NCT01416181|3069811|Superiority or Other|||||||0.7283|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) & BL 9HPT (non-dominant hand).||CP Group: Week 156|
1668043|NCT01416181|3069811|Superiority or Other|||||||0.5051|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) & BL 9HPT (non-dominant hand).||Overall: Week 156|
1668044|NCT01416181|3069812|Superiority or Other|||||||0.2751|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) & BL 9HPT (non-dominant hand).||NP Group: Week 156|
1668045|NCT01416181|3069812|Superiority or Other|||||||0.8781|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) & BL 9HPT (non-dominant hand).||CP Group: Week 156|
1668046|NCT01416181|3069812|Superiority or Other|||||||0.723|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA, adjusted for BL EDSS (≤5.5 or ≥6) & BL 9HPT (non-dominant hand).||Overall: Week 156|
1668047|NCT01416181|3069813|Superiority or Other|||||||0.6095|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) & BL 9HPT (dominant hand).||NP Group: Week 156|
1668048|NCT01416181|3069813|Superiority or Other|||||||0.0585|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) & BL 9HPT (dominant hand).||CP Group: Week 156|
1668049|NCT01416181|3069813|Superiority or Other|||||||0.0261|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) & BL 9HPT (dominant hand).||Overall: Week 156|
1668050|NCT01416181|3069814|Superiority or Other|||||||0.2351|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) & BL 9HPT (dominant hand).||NP Group: Week 156|
1668051|NCT01416181|3069814|Superiority or Other|||||||0.1129|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) & BL 9HPT (dominant hand).||CP Group: Week 156|
1668052|NCT01416181|3069814|Superiority or Other|||||||0.1119|||||||ANCOVA|p-value for comparison between active & placebo groups at Week 156 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) & BL 9HPT (dominant hand).||Overall, Week 156|
1668053|NCT01416181|3069815|Superiority or Other|||||||0.2916|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (<=5.5 or>=6) and BL T25FW.||NP Group: Week 156|
1668054|NCT01416181|3069815|Superiority or Other|||||||0.4957|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (<=5.5 or>=6) and BL T25FW.||CP Group: Week 156|
1668055|NCT01416181|3069815|Superiority or Other|||||||0.096|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (<=5.5 or>=6) and BL T25FW.||Overall: Week 156|
1668056|NCT01416181|3069816|Superiority or Other|||||||0.2506|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (<=5.5 or>=6) and BL T25FW.||NP Group: Week 156|
1668057|NCT01416181|3069816|Superiority or Other|||||||0.1974|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (<=5.5 or>=6) and BL T25FW.||CP Group: Week 156|
1668058|NCT01416181|3069816|Superiority or Other|||||||0.0273|||||||ANCOVA|p-value for comparison between active and placebo at Week 156 based on ANCOVA model, adjusted for BL EDSS (<=5.5 or>=6) and BL T25FW.||Week 156|
1668059|NCT01416181|3069817|Superiority or Other||Odds Ratio (OR)|0.7||||0.141|2-Sided|95.0|0.44|1.12|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (<=5.5 or >=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on 9HPT (non-dominant hand) at 156 weeks|
1668060|NCT01416181|3069817|Superiority or Other||Odds Ratio (OR)|0.63||||0.054|2-Sided|95.0|0.39|1.01|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (<=5.5 or >=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors onm 9HPT (dominant hand) at 156 weeks|
1668061|NCT01416181|3069817|Superiority or Other||Odds Ratio (OR)|0.59||||0.0093|2-Sided|95.0|0.39|0.88|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (<=5.5 or >=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on 9HPT (either hand) at 156 weeks|
1668062|NCT01416181|3069817|Superiority or Other||Odds Ratio (OR)|0.8||||0.1988|2-Sided|95.0|0.57|1.12|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (<=5.5 or >=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on T25FW at 156 weeks|
1668063|NCT01416181|3069817|Superiority or Other||Odds Ratio (OR)|0.73||||0.1305|2-Sided|95.0|0.48|1.1|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (<=5.5 or >=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on EDSS at 156 weeks|
1668064|NCT01416181|3069817|Superiority or Other||Odds Ratio (OR)|0.67||||0.0205|2-Sided|95.0|0.47|0.94|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (<=5.5 or >=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on ≥ 1 of EDSS, T25FW, or 9HPT at 156 weeks|
1668065|NCT01416181|3069818|Superiority or Other||Odds Ratio (OR)|0.78||||0.1052|2-Sided|95.0|0.58|1.05|||Regression, Logistic|Based on logistic regression, adjusted for baseline EDSS (<=5.5 or >=6).|||
1668066|NCT01416181|3069819|Superiority or Other|||||||0.2424||||||natalizumab participants had a baseline after 6 months of treatment and the placebo-to-natalizumab group had a baseline of initiation of treatment|ANCOVA|p-value for comparison between active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (<=5.5 or >=6) and BL brain volume.||Only participants with BL brain volume are included in the p-value calculation.|
1668067|NCT01416181|3069820|Superiority or Other|||||||0.1529|||||||ANCOVA|p-value for comparison between active & placebo groups at Wk 96 based on ANCOVA model, adjusted for BL EDSS (≤5.5 or ≥6) & BL MSIS-29 physical score.|||
1668068|NCT01416181|3069821|Superiority or Other|||||||0.2586|||||||ANCOVA|p-value for comparison between active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (<=5.5 or >=6) and BL ABILHAND.|||
1668918|NCT01400932|3071291|Superiority or Other||||||<|0.001||||||Week 2; IL|ANCOVA||||
1668069|NCT01416181|3069822|Superiority or Other|||||||0.5409|||||||ANCOVA|p-value for comparison between the active and placebo groups at Week 96 is based on ANCOVA model, adjusted for BL EDSS (<=5.5 or >=6) and BL MSWS-12.|||
1668070|NCT01416181|3069823|Superiority or Other||Odds Ratio (OR)|1.16||||0.4369|2-Sided|95.0|0.8|1.7|||Regression, Logistic|Based on logistic regression, adjusted for baseline EDSS (<=5.5 or >=6) and T25FW.|active/placebo||
1668071|NCT01416181|3069825|Superiority or Other||Odds Ratio (OR)|0.58||||0.0091|2-Sided|95.0|0.39|0.87|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (<=5.5 or >=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (non-dominant hand)|
1668072|NCT01416181|3069825|Superiority or Other||Odds Ratio (OR)|0.72||||0.1251|2-Sided|95.0|0.48|1.09|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (<=5.5 or >=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (dominant hand)|
1668073|NCT01416181|3069825|Superiority or Other||Odds Ratio (OR)|0.56||||0.0012|2-Sided|95.0|0.4|0.8|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (<=5.5 or >=6) and/or T25FW and/or 9HPT (either hand).||Confirmed progressors on 9HPT (either hand)|
1668074|NCT01416181|3069825|Superiority or Other||Odds Ratio (OR)|0.98||||0.9137|2-Sided|95.0|0.74|1.3|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (<=5.5 or >=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on T25FW|
1668075|NCT01416181|3069825|Superiority or Other||Odds Ratio (OR)|1.06||||0.753|2-Sided|95.0|0.74|1.53|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (<=5.5 or >=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on EDSS|
1668076|NCT01416181|3069825|Superiority or Other||Odds Ratio (OR)|0.86||||0.2866|2-Sided|95.0|0.66|1.13|||Regression, Logistic|Based on logistic regression, adjusted for Baseline EDSS (<=5.5 or >=6) and/or T25FW and/or 9HPT (either hand).|active/placebo|Confirmed progressors on ≥ 1 of EDSS, T25FW, or 9HPT at 2 years|
1668077|NCT01415583|3069860|Non-Inferiority|This noninferiority margin was set at 5%, meaning a difference in bleeding rates that did not exceed 5% would be taken as evidence that the bleeding with dexamethasone is not greater than that with placebo by more than 5%.||||||0.05|||||||t-test, 1 sided||||
1668078|NCT01415583|3069860|Non-Inferiority|Consistent with the noninferiority design, the null hypothesis states that the bleeding rate in patients receiving perioperative dexamethasone differed from the bleeding rate in patients receiving perioperative placebo; the alternative hypothesis states that the bleeding rate with dexamethasone is not greater than placebo by more than the noninferiority margin.||||||0.05|||||||t-test, 1 sided||||
1668079|NCT01415531|3069862|Superiority or Other||Least Squares Mean Difference|-6.3|||<|0.0001|2-Sided|95.0|-7.7|-4.8|||ANCOVA||||
1668080|NCT01415518|3069863|Superiority or Other||Mean Difference (Net)|-0.106||||0.0073|2-Sided|95.0|-0.183|-0.029|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate|||
1668081|NCT01415518|3069864|Superiority or Other||Mean Difference (Net)|-0.122||||0.001|2-Sided|95.0|-0.194|-0.049|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate|||
1668082|NCT01415518|3069865|Superiority or Other||Mean Difference (Net)|-0.055||||0.2281|2-Sided|95.0|-0.144|0.035|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate|||
1668083|NCT01415518|3069866|Superiority or Other|||||||0.0845|||||||Log Rank|Time to the first COPD exacerbation|||
1668084|NCT01415518|3069866|Superiority or Other||Hazard Ratio (HR)|0.604||||0.088|2-Sided|95.0|0.339|1.078|||Regression, Cox|Time to the first COPD exacerbation|||
1668085|NCT01415518|3069866|Superiority or Other||Rate ratio|0.565||||0.0425|2-Sided|95.0|0.325|0.981|||Poisson regression|Poisson regression model with treatment as a factor and the duration time in study as an offset variable|||
1668086|NCT01415518|3069867|Superiority or Other||Mean Difference (Net)|-0.208||||0.0001|2-Sided|95.0|-0.308|-0.108|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate|||
1668087|NCT01415518|3069868|Superiority or Other||Mean Difference (Net)|-0.193||||0.0002|2-Sided|95.0|-0.294|-0.092|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate|||
1668088|NCT01415518|3069869|Superiority or Other||Mean Difference (Net)|-0.279|||<|0.0001|2-Sided|95.0|-0.381|-0.177|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of score as a covariate|||
1668089|NCT01415518|3069870|Superiority or Other||Mean Difference (Net)|-0.342||||0.0002|2-Sided|95.0|-0.523|-0.162|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate|||
1668090|NCT01415518|3069871|Superiority or Other||Mean Difference (Net)|-0.343||||0.0004|2-Sided|95.0|-0.533|-0.153|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate|||
1668091|NCT01415518|3069872|Superiority or Other||Mean Difference (Net)|-0.297||||0.0102|2-Sided|95.0|-0.522|-0.071|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of reliever medication as a covariate|||
1668092|NCT01415518|3069873|Superiority or Other||Mean Difference (Net)|27.168|||<|0.0001|2-Sided|95.0|18.906|35.431|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1668093|NCT01415518|3069874|Superiority or Other||Mean Difference (Net)|24.322|||<|0.0001|2-Sided|95.0|14.425|34.22|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1668094|NCT01415518|3069875|Superiority or Other||Mean Difference (Net)|31.513|||<|0.0001|2-Sided|95.0|18.74|44.286|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1668095|NCT01415518|3069876|Superiority or Other||Mean Difference (Net)|23.044|||<|0.0001|2-Sided|95.0|14.927|31.161|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1668096|NCT01415518|3069877|Superiority or Other||Mean Difference (Net)|21.136|||<|0.0001|2-Sided|95.0|12.163|30.11|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1668122|NCT01413087|3070033|Superiority|||||||0.992|||||||Log Rank|P value by log-rank test for the difference between treatment groups|||
1668097|NCT01415518|3069878|Superiority or Other||Mean Difference (Net)|25.172||||0.0001|2-Sided|95.0|12.733|37.611|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1668098|NCT01415518|3069879|Superiority or Other||Ratio|1.038||||0.0074|2-Sided|95.0|1.01|1.067|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate|||
1668099|NCT01415518|3069880|Superiority or Other||Ratio|1.035||||0.0248|2-Sided|95.0|1.004|1.066|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate|||
1668100|NCT01415518|3069881|Superiority or Other||Ratio|1.038||||0.0003|2-Sided|95.0|1.017|1.06|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate|||
1668101|NCT01415518|3069882|Superiority or Other||Ratio|1.045|||<|0.0001|2-Sided|95.0|1.024|1.065|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate|||
1668102|NCT01415518|3069883|Superiority or Other||Ratio|1.04||||0.0007|2-Sided|95.0|1.017|1.064|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate|||
1668103|NCT01415518|3069884|Superiority or Other||Ratio|1.068|||<|0.0001||95.0|1.043|1.092|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate|||
1668104|NCT01415518|3069885|Superiority or Other||Ratio|1.067|||<|0.0001|2-Sided|95.0|1.044|1.09|||ANCOVA|Multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate|||
1668105|NCT01415518|3069886|Superiority or Other||Ratio|1.069|||<|0.0001|2-Sided|95.0|1.043|1.096|||ANCOVA|multiplicative ANCOVA model with treatment and centre as fixed factors and baseline value as a (log-transformed) covariate|||
1668106|NCT01415349|3069897|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of Geometric LS Means|1.04|||||2-Sided|90.0|0.998|1.08|||||||
1668107|NCT01415349|3069898|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of Geometric LS Means|1.03|||||2-Sided|90.0|0.966|1.09|||||||
1668108|NCT01415232|3069899|Superiority or Other||Formula calculation|6.54|Standard Deviation|0.68|>|0.05|2-Sided|95.0|6.44|6.65|||Formula calculation||Estimated epidural depth equation depth (cm)|Estimated epidural depth equation depth (cm)|
1668109|NCT01415232|3069899|Superiority or Other||Mean Difference (Final Values)|6.64|Standard Deviation|1.0|>|0.05|2-Sided|95.0|6.5|6.8|||t-test, 2 sided|||Clinical epidural needle depth|
1668110|NCT01415232|3069899|Non-Inferiority or Equivalence|correlation coefficient|transverse plane correlation coefficient|0.9|||>|0.85|2-Sided|95.0|0.87|0.93|||transverse plane correlation coefficient|||Transverse plane correlation coefficient|
1668111|NCT01415232|3069899|Non-Inferiority or Equivalence|Balki et al found a Pearson’s correlation coefficient between the UD and ND depth of 0.85 (95% CI 0.75-0.91). We believe EDE + US would result in a correlation coefficient of approximately 0.91. To keep the lower bound estimate within 0.04 of a correlation of 0.91, and to maintain a 95% confidence level, 140 patients would need to be sampled. To allow for patients who may not complete the study, 160 patients were enrolled.|correlation coefficient|0.91|||<|0.05|2-Sided|95.0|0.87|0.93|||longitudinal correlation coefficient|||Pearson’s correlation coefficient was calculated for epidural distance measurements which included actual clinical epidural needle depth (ND) and the epidural depth equation (EDE), ND and prior EDE + US midline longitudinal plane view, ND and prior EDE + US transverse plane view.|
1668112|NCT01414205|3069948|Superiority or Other||Difference (Hauck-Anderson)|17.89||||0.0779|2-Sided|95.0|-4.95|40.72|||Cochran-Mantel-Haenszel|P-values based on stratified Cochran-Mantel-Haenszel test by the randomization stratification factors as supportive analyses.|||
1668113|NCT01414010|3069979|Superiority or Other||||||<|0.05|||||||ANOVA|||Statistical analysis was performed using a variety of computer packages including XLstat, NCSS 2007, “R” and NCSS 2010|
1668114|NCT01413542|3069997|Superiority or Other|||||||0.04||||||Effect of DPP4 inhibition on venous GLP-1 levels at high dose of intra-arterial GLP-1 (p=0.04 vs. placebo).|Wilcoxon signed rank||||
1668115|NCT01413542|3069997|Superiority or Other|||||||0.01||||||Effect of intra-arterial GLP-1 on venous GLP-1 concentrations during sitagliptin (p=0.01).|Wilcoxon signed rank||||
1668116|NCT01413542|3069997|Superiority or Other|||||||0.01||||||Effect of intra-arterial GLP-1 on venous GLP-1 concentrations during placebo (p=0.01).|wilxocon signed rank test||||
1668117|NCT01413542|3069998|Superiority or Other|||||||0.007||||||Effect of combined DPP4 and ACE inhibition on the change in the norepinephrine AV gradient during substance P as compared to treatment with ACE inhibition alone (p=0.007).|Wilcoxon signed rank||||
1668118|NCT01413542|3069998|Superiority or Other|||||||0.05||||||Effect of combined DPP4 and ACE inhibition on the change in the norepinephrine AV gradient during substance P as compared to treatment with placebo.|Wilcoxon signed rank||||
1668119|NCT01413542|3069999|Superiority or Other|||||||0.011||||||Effect of combined ACE and DPP4 inhibition on change in heart rate in response to max dose substance P (p=0.011 vs placebo; ).|Wilcoxon signed rank|p<0.05 threshold for statistical significance.|||
1668120|NCT01413542|3070000|Superiority or Other|||||||0.02||||||Effect of DPP4 inhibition on tPA release during sub P in women (p=0.02 vs. placebo).Effect of ACE inhibition on tPA release during sub P in women (p<0.001); effect of DPP4 inhibition on tPA release during sub P and (p=0.001 vs. ACE inhibition alone).|Mixed Models Analysis|p<0.05 threshold for statistical significance|||
1668121|NCT01413542|3070001|Superiority or Other||||||<|0.001||||||Effect of ACE inhibition on FBF response to bradykinin (p<0.001). Other comparisons: Effect of DPP4 inhibition on FBF response to bradykinin (p=0.89); Effect of ACE (p=0.16), DPP4 (p=0.82), or combined inhibition (p=0.35) on FBF response to sub P.|Mixed Models Analysis|"Effect of DPP4 inhibition on vasodilator response to GLP-1 (p=0.14) or BNP (p=0.85).~p<0.05 threshold for statistical significance."||"Group 1: The effect of treatment (placebo, ACE or DPP4 inhibitor, or the combination) on vasodilator response to peptide, measured as forearm blood flow was determined.~Group 2: The effect of treatment (placebo, DPP4 inhibitor) on vasodilator response to peptide, measured as percent change in forearm blood flow was determined."|
1668123|NCT01413087|3070034|Superiority|||||||0.483|||||||Log Rank|P value by log-rank test for the difference between treatment groups|||
1668124|NCT01412957|3070039|Superiority or Other||Odds Ratio (OR)|20.0|||<|0.0001|2-Sided|95.0|5.89|101.62|||Stratified exact test|Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.|ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.|
1668125|NCT01412957|3070040|Superiority or Other||Odds Ratio (OR)|24.89|||<|0.0001|2-Sided|95.0|7.47|123.77|||Stratified exact test|Stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|The odds ratio is defined as the odds of having an objective response in the panitumumab plus BSC arm relative to the odds in BSC alone arm.|ORR was not formally tested and the p-values are descriptive only. An exact test was used to test the hypothesis that the common odds ratio for panitumumab plus BSC relative to BSC alone for the objective response is equal to 1.0 stratified by the randomization factors.|
1668126|NCT01412957|3070041|Superiority or Other||Normal score|-5.98|||<|0.0001|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score < 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|PFS in the Wild-type RAS Efficacy Analysis Set was to be compared at a significance level of 5% if overall survival in the wild-type RAS Efficacy Anaysis Set demonstrated a significant treatment effect.|
1668127|NCT01412957|3070042|Superiority or Other||Normal score|-2.47||||0.0135|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score < 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|Overall survival in the Wild-type RAS Efficacy Analysis Set was compared at a significance level of 5% conditional on a significant treatment effect for progression-free survival in the ITT Analysis Set.|
1668128|NCT01412957|3070043|Superiority or Other||Normal score|-6.08|||<|0.0001|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score < 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|PFS in the ITT Analysis Set was tested at a significance level of 5% conditional on a significant treatment effect on overall survival in the ITT Analysis Set.|
1668129|NCT01412957|3070044|Superiority or Other||Normal score|-2.59||||0.0096|||||||Log Rank|Log-rank test stratified by randomization factors: geographic region (Europe vs Asia vs rest of world) and ECOG performance status (0 or 1 vs 2).|A normal score < 0 indicates fewer than expected events for the panitumumab plus BSC arm and therefore a longer time to event.|The primary hypothesis was that panitumumab plus BSC would improve overall survival compared to BSC alone. A comparison between treatments was performed using the log-rank test stratified by the randomization factors at a 5% significance level.|
1668130|NCT01412866|3070062|Superiority or Other|||||||0.08|||||||Chi-squared|df=1|||
1668131|NCT01412801|3070063|Superiority or Other||Vaccine Group ratios (Serotype III)|0.91|||||2-Sided|98.4|0.52|1.58|||||||
1668132|NCT01412801|3070063|Superiority or Other||Vaccine Group ratios (Serotype III)|1.06|||||2-Sided|98.4|0.63|1.78|||||||
1668133|NCT01412801|3070063|Superiority or Other||Vaccine Group ratios (Serotype III)|1.17|||||2-Sided|98.4|0.66|2.07|||||||
1668134|NCT01412801|3070063|Superiority or Other||Vaccine Group ratios (Serotype Ib)|1.32|||||2-Sided|98.4|0.85|2.06|||||||
1668135|NCT01412801|3070063|Superiority or Other||Vaccine Group ratios (Serotype Ib)|1.05|||||2-Sided|98.4|0.65|1.69|||||||
1668136|NCT01412801|3070063|Superiority or Other||Vaccine Group ratios (Serotype Ib)|0.8|||||2-Sided|98.4|0.49|1.29|||||||
1668137|NCT01412801|3070063|Superiority or Other||Vaccine Group ratios (Serotype Ia)|0.84|||||2-Sided|98.4|0.63|1.14|||||||
1668138|NCT01412801|3070063|Superiority or Other||Vaccine Group ratios (Serotype Ia)|0.81|||||2-Sided|98.4|0.6|1.09|||||||
1668139|NCT01412801|3070063|Superiority or Other||Vaccine Group Ratios (Serotype Ia)|0.96|||||2-Sided|98.4|0.71|1.3|||||||
1668140|NCT01412554|3070077|Other|Only descriptive statistics|||||<|0.05|||||||Spearman|The degree of tracking was assessed by Spearman’s rank or Pearson’s correlation coefficient||Only an observational follow-up study|The degree of tracking was assessed by Spearman’s rank or Pearson’s correlation coefficient
1668141|NCT01412541|3070094|Equivalence|The statistical analysis is a likelihood ratio chi-square test for inequality of binomial proportions; the test is a two-sided test at α=0.05. The response variable in each subject will be the presence or absence of at least one efficacy event from the time following the index procedure through 12 months. The study evaluable sample size required for 90% power is approximately 405 subjects. After adjustment for 15% censoring through 12 months, the study size is 476.||||||0.05|||||||Chi-squared|The statistical analysis is a likelihood ratio chi-square test for inequality of binomial proportions; the test is a two-sided test.||"To assess whether the proportion of subjects with at least one efficacy event* in the Test group is equal or not to that of Control group through 12-months post-index procedure.~H0: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is equal to that of the Test group.~H1: The proportion of subjects with efficacy events in the Control group through 12-months post-index procedure is not equal to that of the Test group."|
1668142|NCT01412541|3070095|Non-Inferiority or Equivalence (legacy)|The evaluable sample size required for 90% power is 150 (50 Control plus 100 Test). This endpoint is not the sample-size driver of the study. Randomization of 476 subjects is expected to provide at least 405 evaluable subjects, after adjustment for up to 15% censoring) and approximately 99% power.||||||0.025|||||||Farrington and Manning|||"To assess if proportion of subjects with at least one safety event* in the Test group is inferior or not inferior to that of Control group through 12-months Post index procedure (PPI) H0: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically inferior to that of the Control group.~H1: The proportion of subjects with safety events in the Test group through 12-months PPI is clinically non-inferior to that of the Control group."|
1668143|NCT01412333|3070107|Superiority or Other (legacy)||Relative risk (stratified)|1.81|||<|0.0001|2-Sided|95.0|1.41|2.32|||CMH Chi-Squared test (stratified)|Analyzed using CMH test, stratified by Geographical Region (US vs. rest-of-world) and baseline EDSS (<4.0 vs. >=4.0).|||
1668144|NCT01412333|3070108|Superiority or Other (legacy)||Difference in Adjusted Means|1.159|Standard Error of the Mean|0.564|=|0|2-Sided|95.0|0.051|2.268|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.||
1668145|NCT01412333|3070109|Superiority or Other (legacy)||Difference in Adjusted Means|0.112|Standard Error of the Mean|0.066|=|0|2-Sided|95.0|-0.018|0.241|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in the rate of brain volume loss: 14.9%. Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.||
1668146|NCT01412333|3070110|Superiority or Other (legacy)||Difference in Adjusted Means|0.107|Standard Error of the Mean|0.037|=|0|2-Sided|95.0|0.034|0.18|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.||
1668147|NCT01412333|3070111|Superiority or Other (legacy)||Adjusted rate ratio|0.357|||<|0.0001||95.0|0.272|0.47|||Negative Binomial Model||Adjusted by baseline T1-hypointense lesion count, baseline EDSS (<4.0 vs. >=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.||
1668148|NCT01412333|3070112|Superiority or Other (legacy)||Hazard Ratio (HR)|0.63|||=|0|2-Sided|95.0|0.4|0.98|||Log Rank|||Time to onset of CDP at week 24|
1668149|NCT01412333|3070113|Superiority or Other (legacy)||Relative risk (stratified)|1.14|||=|0|2-Sided|95.0|0.84|1.56|||CMH Chi-Squared test (stratified)|Stratified by Geographical Region (US vs. Rest of World) and baseline EDSS (<4.0 vs. >=4.0).|||
1668150|NCT01412333|3070114|Superiority or Other (legacy)||Adjusted rate ratio|0.171|||<|0.0001||95.0|0.13|0.225|||Negative Binomial Model||Adjusted by baseline T2 lesion count, baseline EDSS (<4.0 vs. >=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.||
1668151|NCT01412333|3070115|Superiority or Other (legacy)||Adjusted rate ratio|0.051|||<|0.0001||95.0|0.029|0.089|||Negative Binomial Model||Adjusted by baseline T1 Gd lesion (present or not), baseline EDSS (<4.0 vs. >=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.||
1668152|NCT01412333|3070116|Superiority or Other (legacy)||Hazard Ratio (HR)|0.63|||=|0|2-Sided|95.0|0.42|0.92|||Log Rank|||Time to onset of CDP at week 12|
1668153|NCT01412333|3070117|Superiority or Other (legacy)||Rate Ratio|0.532|||<|0.0001|2-Sided|95.0|0.397|0.714|||Negative Binomial Model||Rate ratio was calculated as Ocrelizumab ARR/Interferon beta-1a 44 mcg SC ARR.|Adjusted by Geographical Region (US vs. Rest of World) and baseline EDSS (<4.0 vs. >=4.0).|
1668154|NCT01412060|3070144|Superiority or Other||Hazard Ratio (HR)|0.45||||0.001|2-Sided|95.0|0.28|0.73|||Log Rank||Hazard ratio (cariprazine 3-9 mg vs placebo) is based on Cox proportional hazards regression model, with treatment group as an explanatory variable.||
1668155|NCT01412021|3070147|Superiority||||||<|0.0001|||||||paired t-test||||
1668156|NCT01412021|3070148|Superiority||||||<|0.0001|||||||paired t-test||||
1668157|NCT01412021|3070149|Superiority||||||<|0.0001|||||||paired t-test||||
1668158|NCT01412021|3070150|Superiority||||||<|0.0001|||||||paired t-test||||
1668159|NCT01412021|3070151|Superiority||||||<|0.0001|||||||paired t-test||||
1668160|NCT01412021|3070152|Superiority||||||<|0.0001|||||||paired t-test||||
1668161|NCT01412021|3070153|Superiority||||||<|0.0001|||||||paired t-test||||
1668162|NCT01412021|3070154|Superiority||||||<|0.0001|||||||paired t-test||||
1668163|NCT01412021|3070155|Superiority||||||<|0.0001|||||||paired t-test||||
1668164|NCT01412021|3070156|Superiority|||||||0.0132|||||||paired t-test||||
1668165|NCT01412021|3070158|Superiority||||||<|0.0001|||||||paired t-test||||
1668166|NCT01412021|3070159|Superiority||||||<|0.0001|||||||paired t-test||||
1668167|NCT01412021|3070160|Superiority||||||<|0.0001|||||||paired t-test||||
1668168|NCT01412021|3070161|Superiority||||||<|0.0001|||||||paired t-test||||
1668169|NCT01412021|3070162|Superiority||||||<|0.0001|||||||paired t-test||||
1668170|NCT01412021|3070163|Superiority||||||<|0.0001|||||||paired t-test||||
1668171|NCT01412021|3070164|Superiority||||||<|0.0001|||||||paired t-test||||
1668172|NCT01412021|3070165|Superiority||||||<|0.0001|||||||paired t-test||||
1668173|NCT01412021|3070166|Superiority||||||<|0.0001|||||||paired t-test||||
1668174|NCT01412021|3070167|Superiority||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration|||
1668175|NCT01412021|3070168|Superiority||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration|||
1668176|NCT01412021|3070170|Superiority||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration|||
1668177|NCT01412021|3070172|Superiority||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration|||
1668178|NCT01412021|3070173|Superiority||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration|||
1668179|NCT01412021|3070174|Superiority||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration|||
1668180|NCT01412021|3070175|Superiority||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration|||
1668181|NCT01412021|3070176|Superiority||||||<|0.0001|||||||paired t-test|redundancy is not taken into consideration|||
1668182|NCT01411891|3070186|Superiority||Risk Ratio (RR)|0.8||||0.65|2-Sided|95.0|0.4|1.6|||Regression, Logistic||||
1668183|NCT01411891|3070187|Superiority||Risk Ratio (RR)|1.5|||||2-Sided|95.0|0.3|8.4|||||||
1668267|NCT01410240|3070368|Superiority or Other|||||||0.5|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Mental Health|
1668184|NCT01411852|3070188|Superiority or Other||Odds Ratio (OR)|0.62|||||2-Sided|95.0|0.22|1.77|||||Adjusted for age (linear spline with knot at 45 years), penetrating mechanism (yes/no), and ISS (linear).||
1668185|NCT01411852|3070189|Superiority or Other||Odds Ratio (OR)|1.92|||||2-Sided|95.0|0.19|19.11|||||Adjusted for age (linear spline with knot at 45 years) and Injury Severity Score (ISS).||
1668186|NCT01411852|3070190|Superiority or Other||Odds Ratio (OR)|0.17|||||2-Sided|95.0|0.03|0.92|||||Adjusted for age (linear spline with knot at 45 years) and Injury Severity Score (ISS). ISS multiply imputed for one patient.||
1668187|NCT01411852|3070191|Superiority or Other||Mean Difference (Final Values)|0.1|||||2-Sided|95.0|-2.9|3.1|||||||
1668188|NCT01411852|3070192|Superiority or Other||Mean Difference (Final Values)|-0.6|||||2-Sided|95.0|-3.6|2.4|||||||
1668189|NCT01411852|3070193|Superiority or Other||Mean Difference (Final Values)|-0.9|||||2-Sided|95.0|-3.8|2.1|||||||
1668190|NCT01411852|3070194|Superiority or Other||percent difference|-4.4|||||2-Sided|95.0|-16.6|7.8|||||||
1668191|NCT01411852|3070195|Superiority or Other||percent difference|-10.4|||||2-Sided|95.0|-29.6|8.8|||||||
1668192|NCT01411852|3070196|Superiority or Other||percent difference|-18.9|||||2-Sided|95.0|-39.2|1.4|||||||
1668193|NCT01411852|3070197|Superiority or Other||percent difference|-10.2|||||2-Sided|95.0|-22.4|2.0|||||||
1668194|NCT01411852|3070198|Superiority or Other||Mean Difference (Final Values)|0.02|||||2-Sided|95.0|-0.06|0.1|||||||
1668195|NCT01411852|3070199|Superiority or Other||Mean Difference (Final Values)|-20.4|||||2-Sided|95.0|-42.5|1.6|||||||
1668196|NCT01411852|3070200|Superiority or Other||Mean Difference (Final Values)|0.4|||||2-Sided|95.0|-0.3|1.0|||||||
1668197|NCT01411852|3070201|Superiority or Other||Mean Difference (Final Values)|0.2|||||2-Sided|95.0|-1.8|2.2|||||||
1668198|NCT01411852|3070202|Superiority or Other||Mean Difference (Final Values)|-0.77|||||2-Sided|95.0|-1.61|0.08|||||||
1668199|NCT01411852|3070203|Superiority or Other||Mean Difference (Final Values)|-1.18|||||2-Sided|95.0|-2.76|0.4|||||||
1668200|NCT01411852|3070204|Superiority or Other||percent difference|-16.0|||||2-Sided|95.0|-26.5|-5.5|||||||
1668201|NCT01411852|3070205|Superiority or Other||Odds Ratio (OR)|0.39|||||2-Sided|95.0|0.12|1.25|||||Adjusted for age (linear spline with knot at 45 years), penetrating vs. blunt or no trauma (1 patient had neither blunt nor penetrating trauma), and Injury Severity Score (ISS). ISS multiply imputed for one patient.||
1668202|NCT01411774|3070210|Superiority|||||||0.95||||||p < .05 was the threshold of significance.|Mixed Models Analysis|Analysis for the outcomes used linear mixed-effects models, with treatment group as the between-participant factor and time as the within group factor|||
1668203|NCT01411501|3070219|Superiority or Other|||||||0.035|||||||Kruskal-Wallis||||
1668204|NCT01411501|3070220|Superiority or Other|||||||0.198|||||||ANCOVA||||
1668205|NCT01411501|3070221|Superiority or Other|||||||0.005|||||||ANCOVA||||
1668206|NCT01411501|3070222|Superiority or Other|||||||0.841|||||||Kruskal-Wallis||||
1668207|NCT01411501|3070223|Superiority or Other|||||||0.968|||||||ANCOVA||||
1668208|NCT01411501|3070224|Superiority or Other|||||||0.352|||||||ANCOVA||||
1668209|NCT01411241|3070237|Non-Inferiority|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|-0.36|||||2-Sided|95.0|-4.87|4.06||||||Non-inferiority (Group 1 - Group 2); Anti-FHA. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.|
1668210|NCT01411241|3070237|Non-Inferiority|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|-0.56|||||2-Sided|95.0|-3.93|2.69||||||Non-inferiority (Group 1 - Group 2); Anti-PT. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.|
1668211|NCT01411241|3070237|Non-Inferiority|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||2-Sided|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-PRP. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.|
1668212|NCT01411241|3070237|Non-Inferiority|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||2-Sided|95.0|-1.15|2.09||||||Non-inferiority (Group 1 - Group 2); Anti-polio 3. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.|
1668213|NCT01411241|3070237|Non-Inferiority|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||2-Sided|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-polio 2. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.|
1668214|NCT01411241|3070237|Non-Inferiority|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||2-Sided|95.0|-1.14|2.08||||||Non-inferiority (Group 1 - Group 2); Anti-polio 1. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.|
1668215|NCT01411241|3070237|Non-Inferiority|The non-inferiority was demonstrated if the lower limit of all the 95% CI of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.37|||||2-Sided|95.0|-1.14|2.07||||||Non-inferiority (Group 1 - Group 2); Anti-tetanus. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.|
1668216|NCT01411241|3070237|Non-Inferiority|The non-inferiority was demonstrated if the lower limit of all the 95% Confidence Interval (CI) of the difference is greater than -10% for all antigens. Wilson score (without continuity adjustment) 95% two-sided CI was used for the difference of seroprotection/booster rates.|Difference in percentage|0.0|||||2-Sided|95.0|-1.48|1.4||||||Non-inferiority (Group 1 - Group 2); Anti-diphtheria. Non-inferiority of Pentaxim booster dose based on seroprotection/booster response was assessed 28 days after injection.|
1668217|NCT01411085|3070263|Superiority||Mean Difference (Final Values)|7.0||||0.317|2-Sided||||||t-test, 2 sided|||The assessment was between baseline and values for last 8 weeks.|
1668218|NCT01410448|3070310|Superiority or Other|||||||0.0921|||||||Regression, Logistic||||
1668219|NCT01410357|3070320|Superiority|||||||0.227|||||||Mixed Models Analysis||||
1668220|NCT01410357|3070321|Superiority|||||||0.014|||||||Mixed Models Analysis||||
1668221|NCT01410357|3070322|Superiority|||||||0.878|||||||Mixed Models Analysis||||
1668222|NCT01410357|3070323|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1668223|NCT01410357|3070324|Superiority|||||||0.156|||||||Mixed Models Analysis||||
1668224|NCT01410357|3070325|Superiority|||||||0.156|||||||Mixed Models Analysis||||
1668225|NCT01410357|3070326|Superiority|||||||0.758|||||||Mixed Models Analysis||||
1668226|NCT01410357|3070327|Superiority|||||||0.573|||||||Mixed Models Analysis||||
1668227|NCT01410357|3070328|Superiority|||||||0.51|||||||Mixed Models Analysis||||
1668228|NCT01410357|3070329|Superiority|||||||0.853|||||||Mixed Models Analysis||||
1668229|NCT01410357|3070330|Superiority|||||||0.853|||||||Mixed Models Analysis||||
1668230|NCT01410357|3070331|Superiority|||||||0.838|||||||Mixed Models Analysis||||
1668231|NCT01410357|3070332|Superiority|||||||0.707|||||||Mixed Models Analysis||||
1668232|NCT01410357|3070333|Superiority|||||||0.87|||||||Mixed Models Analysis||||
1668233|NCT01410357|3070334|Superiority|||||||0.407|||||||Mixed Models Analysis||||
1668234|NCT01410357|3070335|Superiority|||||||0.68|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.|||
1668235|NCT01410357|3070336|Superiority|||||||0.175|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.|||
1668236|NCT01410357|3070337|Superiority|||||||0.633|||||||Mixed Models Analysis||||
1668237|NCT01410357|3070338|Superiority|||||||0.662|||||||Mixed Models Analysis||||
1668238|NCT01410357|3070339|Superiority|||||||0.872|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.|||
1668239|NCT01410357|3070340|Superiority|||||||0.086|||||||Mixed Models Analysis||||
1668240|NCT01410357|3070341|Superiority|||||||0.003|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.|||
1668241|NCT01410357|3070342|Superiority||||||<|0.001|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.|||
1668242|NCT01410357|3070343|Superiority|||||||0.016|||||||Mixed Models Analysis|A Bonferroni correction was conducted to adjust for multiple comparisons.|||
1668243|NCT01410357|3070344|Superiority|||||||0.785||||||Bonferroni corrections were conducted to adjust for multiple comparisons.|Mixed Models Analysis||||
1668244|NCT01410240|3070366|Superiority or Other|||||||0.052|||||||two-sided Wilcoxon rank sum test||||
1668245|NCT01410240|3070368|Superiority or Other|||||||0.255|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Mental Component Summary|
1668246|NCT01410240|3070368|Superiority or Other|||||||0.448|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Physical Component Summary|
1668247|NCT01410240|3070368|Superiority or Other|||||||0.307|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Mental Health|
1668248|NCT01410240|3070368|Superiority or Other|||||||0.036|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Role-Emotional|
1668249|NCT01410240|3070368|Superiority or Other|||||||0.265|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Social Functioning|
1668250|NCT01410240|3070368|Superiority or Other|||||||0.293|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Vitality|
1668251|NCT01410240|3070368|Superiority or Other|||||||0.94|||||||two-sided Wilcoxon rank sum test|||Change Week 6: General Health|
1668252|NCT01410240|3070368|Superiority or Other|||||||0.071|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Bodily Pain|
1668253|NCT01410240|3070368|Superiority or Other|||||||0.298|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Role-Physical|
1668254|NCT01410240|3070368|Superiority or Other|||||||0.107|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Physical Functioning|
1668255|NCT01410240|3070368|Superiority or Other|||||||0.14|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Mental Component Summary|
1668256|NCT01410240|3070368|Superiority or Other|||||||0.481|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Component Summary|
1668257|NCT01410240|3070368|Superiority or Other|||||||0.635|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Mental Health|
1668258|NCT01410240|3070368|Superiority or Other|||||||0.086|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Role-Emotional|
1668259|NCT01410240|3070368|Superiority or Other|||||||0.661|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Social Functioning|
1668260|NCT01410240|3070368|Superiority or Other|||||||0.823|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Vitality|
1668261|NCT01410240|3070368|Superiority or Other|||||||0.447|||||||two-sided Wilcoxon rank sum test|||Change Week 2: General Health|
1668262|NCT01410240|3070368|Superiority or Other|||||||0.049|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Bodily Pain|
1668263|NCT01410240|3070368|Superiority or Other|||||||0.524|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Role-Physical|
1668264|NCT01410240|3070368|Superiority or Other|||||||0.574|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Functioning|
1668265|NCT01410240|3070368|Superiority or Other|||||||0.959|||||||Wilcoxon (Mann-Whitney)|||Change Week 1: Mental Component Summary|
1668266|NCT01410240|3070368|Superiority or Other|||||||0.849|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Component Summary|
1668268|NCT01410240|3070368|Superiority or Other|||||||0.254|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Role-Emotional|
1668269|NCT01410240|3070368|Superiority or Other|||||||0.122|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Social Functioning|
1668270|NCT01410240|3070368|Superiority or Other|||||||0.705|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Vitality|
1668271|NCT01410240|3070368|Superiority or Other|||||||0.556|||||||two-sided Wilcoxon rank sum test|||Change Week 1: General Health|
1668272|NCT01410240|3070368|Superiority or Other|||||||0.668|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Bodily Pain|
1668273|NCT01410240|3070368|Superiority or Other|||||||0.714|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Role-Physical|
1668274|NCT01410240|3070368|Superiority or Other|||||||0.962|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Functioning|
1668275|NCT01410240|3070370|Superiority or Other|||||||0.134|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Total Score|
1668276|NCT01410240|3070370|Superiority or Other|||||||0.134|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Average Score|
1668277|NCT01410240|3070370|Superiority or Other|||||||0.153||||||Change Week 6: Physical Functioning|two-sided Wilcoxon rank sum test||||
1668278|NCT01410240|3070370|Superiority or Other|||||||0.044|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Stiffness|
1668279|NCT01410240|3070370|Superiority or Other|||||||0.126|||||||two-sided Wilcoxon rank sum test|||Change Week 6: Pain|
1668280|NCT01410240|3070370|Superiority or Other|||||||0.012|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Total Score|
1668281|NCT01410240|3070370|Superiority or Other|||||||0.012|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Average Score|
1668282|NCT01410240|3070370|Superiority or Other|||||||0.026|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Physical Functioning|
1668283|NCT01410240|3070370|Superiority or Other|||||||0.077|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Stiffness|
1668284|NCT01410240|3070370|Superiority or Other|||||||0.171|||||||two-sided Wilcoxon rank sum test|||Change Week 2: Pain|
1668285|NCT01410240|3070370|Superiority or Other|||||||0.501|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Total Score|
1668286|NCT01410240|3070370|Superiority or Other|||||||0.501|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Average Score|
1668287|NCT01410240|3070370|Superiority or Other|||||||0.594|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Physical Functioning|
1668288|NCT01410240|3070370|Superiority or Other|||||||0.709|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Stiffness|
1668289|NCT01410240|3070370|Superiority or Other|||||||0.978|||||||two-sided Wilcoxon rank sum test|||Change Week 1: Pain|
1668290|NCT01410240|3070370|Superiority or Other|||||||0.343|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Total Score|
1668291|NCT01410240|3070370|Superiority or Other|||||||0.343|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Average Score|
1668292|NCT01410240|3070370|Superiority or Other|||||||0.693|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Physical Functioning|
1668293|NCT01410240|3070370|Superiority or Other|||||||0.269|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Stiffness|
1668294|NCT01410240|3070370|Superiority or Other|||||||0.534|||||||two-sided Wilcoxon rank sum test|||Change Day 3: Pain|
1668295|NCT01410240|3070372|Superiority or Other|||||||0.016|||||||two-sided Wilcoxon rank sum test||||
1668296|NCT01410240|3070373|Superiority or Other|||||||0.161|||||||two-sided Wilcoxon rank sum test||||
1668297|NCT01410240|3070374|Superiority or Other|||||||0.421|||||||two-sided Wilcoxon rank sum test||||
1668298|NCT01410240|3070375|Superiority or Other|||||||0.058|||||||two-sided Wilcoxon rank sum test||||
1668299|NCT01410240|3070378|Superiority or Other|||||||0.063|||||||two-sided Wilcoxon rank sum test||||
1668300|NCT01410240|3070379|Superiority or Other|||||||0.314|||||||two-sided Wilcoxon rank sum test||||
1668301|NCT01410240|3070382|Superiority or Other|||||||0.734|||||||two-sided Wilcoxon rank sum test||||
1668302|NCT01410240|3070383|Superiority or Other|||||||0.533|||||||one-sided Wilcoxon rank sum test||||
1668303|NCT01410240|3070384|Superiority or Other|||||||0.356|||||||one-sided Wilcoxon rank sum test||||
1668304|NCT01410240|3070385|Superiority or Other|||||||0.561|||||||one-sided Wilcoxon rank sum test||||
1668305|NCT01410240|3070386|Superiority or Other|||||||0.527|||||||one-sided, two-sample t-test||||
1668306|NCT01410240|3070387|Superiority or Other|||||||0.708|||||||one-sided, two-sample t-test||||
1668307|NCT01410240|3070388|Superiority or Other|||||||0.453|||||||one-sided, two-sample t-test||||
1668308|NCT01410227|3070455|Non-Inferiority or Equivalence|The null hypothesis of the rate of subjects with a treatment success of <= 0.65 (H0: p <= 0.65) versus an alternative hypothesis of > 0.65 (HA: p > 0.65) was tested at the 5% one-sided level of significance. The proportion of subjects with treatment success under the alternative hypothesis was expected to be approximately 0.90. If 20 subjects were treated, the study provided 86% power to reject the null hypothesis.|Clopper-Pearson|100.0|||||2-Sided|90.0|84.7|100.0|||||||
1668309|NCT01410110|3070456|Superiority or Other||Slope|3.86|Standard Error of the Mean|2.77||0.17|2-Sided|95.0|-1.73|9.46||a priori p-value is .05. for two-tailed test. Positive estimated value is in the direction of the experimental condition.|Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition F Test (df = 1,39.8)|
1668310|NCT01410110|3070457|Superiority or Other||Slope|2.025|Standard Error of the Mean|0.93||0.03|2-Sided|95.0|0.169|3.93|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects Time X Condition F Test (df = 1,37.8)|
1668311|NCT01410110|3070458|Superiority or Other||Slope|1.16|Standard Error of the Mean|0.42||0.008|2-Sided|95.0|0.32|2.01|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects Time X Condition F Test (df = 1,70.15)|
1668312|NCT01410110|3070459|Superiority or Other||Slope|-0.42|Standard Error of the Mean|0.62||0.5|2-Sided|95.0|-1.67|0.83|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition, F Test F (df = 1,42.4)|
1668313|NCT01410110|3070460|Superiority or Other||Slope|-0.37|Standard Error of the Mean|0.84||0.67|2-Sided|95.0|-2.07|1.33|||Mixed Models Analysis|Time X Condition||Type III Fixed Effects for Time X Condition F Test (df = 1,36.86)|
1668314|NCT01410110|3070461|Superiority or Other||Mean Difference (Final Values)|0.152|Standard Error of the Mean|0.952||0.87|2-Sided|95.0|-1.77|2.08||a priori threshold p < .05|t-test, 2 sided|df=39|||
1668315|NCT01410110|3070462|Superiority or Other||Mean Difference (Final Values)|-2.49|Standard Error of the Mean|2.41|<|0.31|2-Sided|95.0|-7.36|2.39||a priori threshold p < .05|t-test, 2 sided||||
1668316|NCT01410110|3070463|Superiority or Other||Slope|0.162|Standard Error of the Mean|0.94||0.86|2-Sided|95.0|-1.73|2.05||Time X Condition|Mixed Models Analysis|Mixed Models allows for all randomized participants (N=48) to be included in the model.||F Test (df = 1,39.32), Type III Fixed Effects for Time X Condition|
1668317|NCT01410110|3070464|Superiority or Other||Mean Difference (Final Values)|-2.66|Standard Error of the Mean|4.41||0.55|2-Sided|95.0|-11.57|6.25||a prior threshold p < .05|t-test, 2 sided|df = 40||t-test for equality of means|
1668318|NCT01409707|3070496|Superiority or Other||||||=|0||||||The a priori threshold for statistical significance was set at p=.05.|Mixed Models Analysis|||Multilevel mixed modeling was employed. The null hypothesis was that there would be no differences in alcohol use at posttreatment.|
1668319|NCT01409707|3070497|Superiority or Other||||||=|0||||||The a priori threshold for statistical significance was set at p = .05.|Mixed Models Analysis|||Multilevel mixed modeling was employed. The null hypothesis was that there'd be no differences between groups at posttreatment on posttraumatic stress disorder measures or alcohol use measures.|
1668320|NCT01409564|3070498|Superiority or Other|||||||0.87|||||||Chi-squared|||Distribution of Fazekas scale in two groups according to Chi-square test results.|
1668321|NCT01409564|3070499|Superiority or Other|||||||0.79|||||||Chi-squared|||Repeated ANOVA, tested for group*time interaction effect of Summed CDR scores on three data points (Baseline, 12-week, 24-week)|
1668322|NCT01409564|3070500|Superiority or Other|||||||0.82|||||||Repeated ANOVA|||Repeated ANOVA, tested for group*time interaction effect of ADCS-ADL scores on three data points (Baseline, 12-week, 24-week)|
1668323|NCT01409564|3070501|Superiority or Other|||||||0.15|||||||Repeated ANOVA|||Repeated ANOVA, tested for group*time interaction effect of MMSE scores on three data points (Baseline, 12-week, 24-week)|
1668324|NCT01409564|3070502|Superiority or Other|||||||0.93|||||||Repeated ANOVA|||Repeated ANOVA, tested for group*time interaction effect of ADAS-Cog scores on three data points (Baseline, 12-week, 24-week)|
1668325|NCT01409564|3070503|Superiority or Other|||||||0.08|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group*time interaction effect in glucose uptake of Right Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).|
1668326|NCT01409564|3070503|Superiority or Other||||||<|0.01|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group*time interaction effect in glucose uptake of Left Inferior Frontal Gyrus in two groups on two data points (baseline, 24-week).|
1668327|NCT01409564|3070503|Superiority or Other||||||<|0.08|||||||Repeated ANOVA|||Repeated-measures analysis of variance (ANOVA) was used to test group*time interaction effect in glucose uptake of Right Parietal Lobe in two groups on two data points (baseline, 24-week).|
1668328|NCT01409564|3070503|Superiority or Other||||||<|0.14|||||||Repeated ANOVA|Uncorrected, Repeated ANOVA||Repeated-measures analysis of variance (ANOVA) was used to test group*time interaction effect in glucose uptake of Left Parietal Lobe in two groups on two data points (baseline, 24-week).|
1668329|NCT01409382|3070509|Superiority or Other||Odds Ratio (OR)|3.4|Standard Deviation|1.0|<|0.05|2-Sided|95.0|1.5|7.6|||Chi-squared|||Take home babies|
1668330|NCT01409239|3070514|Superiority or Other|||||||0.05||||||Wilcoxon rank-sum was used to determine differences between groups.|Wilcoxon (Mann-Whitney)|||Since this was a pilot study no formal power analysis was possible. It was hypothesized that IV insulin would be associated with lower LF/HF HRV.|
1668331|NCT01409096|3070517|Superiority or Other|||||||0.511|||||||ANCOVA|||Baseline HRSA used as a covariate.|
1668332|NCT01409096|3070518|Superiority or Other|||||||0.606|||||||ANOVA|||Baseline YMRS used as a covariate.|
1668333|NCT01409096|3070519|Superiority or Other|||||||0.5187|||||||ANCOVA|||Baseline IDS-SR used as a covariate.|
1668334|NCT01409096|3070520|Superiority or Other|||||||0.9084|||||||ANCOVA|||Baseline HRSD scores used as covariate.|
1668335|NCT01408901|3070533|Superiority||Mean Difference (Final Values)|-0.004||||0.17|2-Sided|95.0|-0.009|0.002|||t-test, 2 sided||||
1668336|NCT01408901|3070534|Superiority||Mean Difference (Final Values)|-0.005||||0.09|2-Sided|95.0|-0.012|0.001|||t-test, 2 sided||||
1668337|NCT01408901|3070535|Superiority||Mean Difference (Final Values)|-0.005||||0.03|2-Sided|95.0|-0.01|-0.001|||t-test, 2 sided||||
1668338|NCT01408901|3070536|Superiority||Mean Difference (Final Values)|-0.006||||0.09|2-Sided|95.0|-0.012|0.001|||t-test, 2 sided||||
1668339|NCT01408901|3070537|Superiority||Mean Difference (Final Values)|3.7|||<|0.01|2-Sided|95.0|2.2|5.2||The P value is a Hochberg-adjusted P value.|t-test, 2 sided||||
1668340|NCT01408901|3070537|Superiority||Mean Difference (Final Values)|-0.6|||<|0.44|2-Sided|95.0|-2.1|0.9||The P value is a Hochberg-adjusted P value.|t-test, 2 sided||||
1668341|NCT01408901|3070537|Superiority||Mean Difference (Final Values)|-0.7|||<|0.44|2-Sided|95.0|-2.1|0.8||The P value is a Hochberg-adjusted P value.|t-test, 2 sided||||
1668342|NCT01408901|3070537|Superiority||Mean Difference (Final Values)|3.6|||<|0.01|2-Sided|95.0|2.1|5.0||The P value is a Hochberg-adjusted P value.|t-test, 2 sided||||
1668343|NCT01408901|3070538|Superiority||Hodges-Lehmann estimator|0.48||||0.49|2-Sided|95.0|-0.64|1.59||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)||||
1668344|NCT01408901|3070538|Superiority||Hodges-Lehmann estimator|0.36||||0.49|2-Sided|95.0|-0.66|1.38||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)||||
1668345|NCT01408901|3070538|Superiority||Hodges-Lehmann estimator|-0.67||||0.49|2-Sided|95.0|-1.84|0.51||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)||||
1668346|NCT01408901|3070538|Superiority||Hodges-Lehmann estimator|-0.61||||0.49|2-Sided|95.0|-1.67|0.44||The P value is a Hochberg-adjusted P value.|Wilcoxon (Mann-Whitney)||||
1668347|NCT01408901|3070539|Superiority||Mean Difference (Final Values)|33.6||||0.02|2-Sided|95.0|9.4|57.7||The P value is a Hochberg-adjusted P value.|t-test, 2 sided||||
1668348|NCT01408901|3070539|Superiority||Mean Difference (Final Values)|-1.4||||0.91|2-Sided|95.0|-25.2|22.4||The P value is a Hochberg-adjusted P value.|t-test, 2 sided||||
1668349|NCT01408901|3070539|Superiority||Mean Difference (Final Values)|-6.3||||0.91|2-Sided|95.0|-30.2|17.6||The P value is a Hochberg-adjusted P value.|t-test, 2 sided||||
1668350|NCT01408901|3070539|Superiority||Mean Difference (Final Values)|28.7||||0.052|2-Sided|95.0|5.1|52.3||The P value is a Hochberg-adjusted P value.|t-test, 2 sided||||
1668351|NCT01408862|3070546|Superiority or Other||Mean Difference (Final Values)|0.0||||0.2|||||||ANOVA|||Results will be expressed as mean + SD from independent experiments. Statistical significance between means were determined by two-way ANOVA with repeated measures on one factor, for variables measured in several consecutive times. Variable will be log-transformed if they were not normally distributed. Wilcoxon test for paired samples was used. The Statistica program package (StatSoft V 6.0) were used to perform these analyses, which applied to both GLP1R and GIPR agonist effect categories.|
1668352|NCT01408862|3070547|Superiority or Other||Mean Difference (Final Values)|0.0||||0.04|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)|||"Results will be expressed as mean + SD from independent experiments. Statistical significance between means were determined by Wilcoxon-paired test. Variable will be log-transformed if they were not normally distributed. . We used the CSS/ Statistica program package, StatSoft V 6.0.~This analysis applies to both GLP1R and GIPR categories"|
1668353|NCT01408303|3070591|Superiority or Other||LS mean difference relative to olive oil|-6.0|||<|0.0001|||||||ANCOVA|p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel's procedure.|||
1668354|NCT01408303|3070591|Superiority or Other||LS mean difference relative to olive oil|-2.95|||<|0.05|||||||ANCOVA|p-value from ANCOVA with factors for treatment, statin use and potency, and baseline value as a covariate, and adjusted using Hommel’s procedure.|||
1668355|NCT01408030|3070605|Other|Two sided testing was performed with a significance level of 0.05.||||||0.08|||||||Fisher Exact||||
1668356|NCT01408030|3070606|Other|Two sided testing was performed with a significance level of 0.05.||||||0.42|||||||Fisher Exact||||
1668357|NCT01408030|3070607|Other|Two sided testing was performed with a significance level of 0.05.||||||0.43|||||||ANCOVA|Adjusted for baseline values and random effect of clinic site.|||
1668358|NCT01408030|3070608|Other|Two sided testing was performed with a significance level of 0.05.|||||<|0.001||||||"A mixed-model repeated-measures ANOVA was used to analyze ESS for drug and time (baseline, week 12) effects.~Listed P value is for time effect."|Mixed Models Analysis|Clinical site and patient were included in the model as random effects.|||
1668359|NCT01408030|3070609|Other|Two sided testing was performed with a significance level of 0.05.||||||0.47|||||||ANOVA||||
1668360|NCT01408030|3070610|Other|Two sided testing was performed with a significance level of 0.05.||||||0.97|||||||ANOVA||||
1668361|NCT01407952|3070611|Superiority||||||<|0.01|||||||Chi-squared||||
1668362|NCT01407952|3070612|Superiority||||||<|0.01|||||||Chi-squared|Chi-squared test statistic with one degree of freedom=14.743|||
1668363|NCT01407952|3070613|Superiority|||||||0.245|||||||Fisher Exact||||
1668364|NCT01407952|3070614|Superiority|||||||0.162|||||||Chi-squared|Chi-squared test statistic with one degree of freedom=1.955|||
1668365|NCT01407952|3070615|Superiority|||||||0.003|||||||Chi-squared|chi-square test statistic with one degree of freedom=8.82|||
1668366|NCT01407952|3070616|Superiority|||||||0.641|||||||Chi-squared|Chi-square test statistic with one degree of freedom=0.217|||
1668367|NCT01407952|3070617|Superiority|||||||0.769|||||||Cochran-Armitage Trend Test||||
1668368|NCT01407952|3070618|Superiority|||||||0.352|||||||Chi-squared|Chi-squared test statistic with one degree of freedom = 0.865|||
1668369|NCT01407952|3070619|Superiority|||||||0.578|||||||Wilcoxon (Mann-Whitney)||||
1668370|NCT01407952|3070620|Superiority||||||<|0.01|||||||t-test, 2 sided||||
1668371|NCT01407952|3070621|Superiority||Odds Ratio (OR)|3.97|||<|0.01|2-Sided|95.0|1.99|7.92||Chi-squared test statistic with one degree of freedom=17.37|Chi-squared||||
1668372|NCT01407952|3070621|Superiority||Odds Ratio (OR)|2.32|||<|0.002|2-Sided|95.0|1.36|3.97|||Regression, Logistic|||A intent to treat analysis was performed, using multiple imputation methods.|
1668373|NCT01407367|3070648|Other||Hazard Ratio (HR)|1.03||||0.86|2-Sided|95.0|0.53|1.99||calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.|Regression, Cox||||
1668374|NCT01407367|3070649|Other||Hazard Ratio (HR)|0.38||||0.04|2-Sided|95.0|0.16|0.94||calculated p-value. Results adjusted for gender, race, age, BMI, MAP, eGFR, smoking history, diabetes, hypertension, cardiovascular disease, cancer, education employment status, health literacy and RAAS use.|Regression, Cox||||
1668375|NCT01407354|3070653|Superiority or Other|||||||0.024|||||||Wilcoxon (Mann-Whitney)|threshold p value for statistical significance=0.05|||
1668376|NCT01407354|3070653|Superiority or Other|||||||0.05|||||||Chi-squared, Corrected||||
1668377|NCT01407276|3070659|Superiority or Other||GMR of Panel E:Panel F|0.5|||||2-Sided|90.0|0.37|0.67|||||||
1668378|NCT01407276|3070659|Superiority or Other||GMR of Panel C:Panel D|0.9|||||2-Sided|90.0|0.7|1.15|||||||
1668379|NCT01407276|3070659|Superiority or Other||GMR of Panel A:Panel B|0.86|||||2-Sided|90.0|0.69|1.07|||||||
1668380|NCT01407276|3070660|Superiority or Other||GMR of Panel E:Panel F|0.5|||||2-Sided|90.0|0.37|0.67|||||||
1668381|NCT01407276|3070660|Superiority or Other||GMR of Panel C:Panel D|0.9|||||2-Sided|90.0|0.7|1.15|||||||
1668382|NCT01407276|3070660|Superiority or Other||GMR of Panel A:Panel B|0.86|||||2-Sided|90.0|0.69|1.07|||||||
1668383|NCT01407276|3070661|Superiority or Other||GMR of Panel E:Panel F|0.42|||||2-Sided|90.0|0.33|0.54|||||||
1668384|NCT01407276|3070661|Superiority or Other||GMR of Panel C:Panel D|0.73|||||2-Sided|90.0|0.55|0.96|||||||
1668385|NCT01407276|3070661|Superiority or Other||GMR of Panel A:Panel B|0.93|||||2-Sided|90.0|0.74|1.18|||||||
1668386|NCT01407276|3070662|Superiority or Other||GMR of Panel G:Panel H|0.51|||||2-Sided|90.0|0.38|0.68|||||||
1668387|NCT01407276|3070662|Superiority or Other||GMR of Panel G:Panel H|0.53|||||2-Sided|90.0|0.39|0.71|||||||
1668388|NCT01407276|3070662|Superiority or Other||GMR of Panel E:Panel F|0.64|||||2-Sided|90.0|0.54|0.76|||||||
1668389|NCT01407276|3070662|Superiority or Other||GMR of Panel C:Panel D|0.75|||||2-Sided|90.0|0.62|0.89|||||||
1668390|NCT01407276|3070662|Superiority or Other||GMR of Panel A:Panel B|1.06|||||2-Sided|90.0|0.9|1.25|||||||
1668391|NCT01407276|3070663|Superiority or Other||GMR of Panel G:Panel H|0.8|||||2-Sided|90.0|0.57|1.12|||||||
1668392|NCT01407276|3070663|Superiority or Other||GMR of Panel G:Panel H|0.7|||||2-Sided|90.0|0.5|0.98|||||||
1668393|NCT01407276|3070663|Superiority or Other||GMR of Panel E:Panel F|0.68|||||2-Sided|90.0|0.51|0.92|||||||
1668394|NCT01407276|3070663|Superiority or Other||GMR of Panel C:Panel D|0.75|||||2-Sided|90.0|0.53|1.07|||||||
1668395|NCT01407276|3070663|Superiority or Other||GMR of Panel A:Panel B|1.11|||||2-Sided|90.0|0.87|1.42|||||||
1668396|NCT01407276|3070664|Superiority or Other||GMR of Panel G:Panel H|1.88|||||2-Sided|90.0|1.4|2.52|||||||
1668397|NCT01407276|3070664|Superiority or Other||GMR of Panel G:Panel H|1.9|||||2-Sided|90.0|1.41|2.54|||||||
1668398|NCT01407276|3070664|Superiority or Other||GMR of Panel E:Panel F|1.83|||||2-Sided|90.0|1.49|2.24|||||||
1668399|NCT01407276|3070664|Superiority or Other||GMR of Panel C:Panel D|1.45|||||2-Sided|90.0|1.19|1.76|||||||
1668400|NCT01407276|3070664|Superiority or Other||GMR of Panel A:Panel B|0.92|||||2-Sided|90.0|0.75|1.12|||||||
1668401|NCT01407276|3070665|Superiority or Other||GMR of Panel G:Panel H|1.3|||||2-Sided|90.0|1.0|1.68|||||||
1668402|NCT01407276|3070665|Superiority or Other||GMR of Panel G:Panel H|1.38|||||2-Sided|90.0|1.06|1.79|||||||
1668403|NCT01407276|3070665|Superiority or Other||GMR of Panel E:Panel F|1.37|||||2-Sided|90.0|1.13|1.65|||||||
1668404|NCT01407276|3070665|Superiority or Other||GMR of Panel C:Panel D|1.33||||||90.0|1.07|1.65|||||||
1668405|NCT01407276|3070665|Superiority or Other||GMR of Panel A:Panel B|0.92|||||2-Sided|90.0|0.81|1.05|||||||
1668406|NCT01407276|3070666|Superiority or Other||GMR of Panel E:Panel F|0.73|||||2-Sided|90.0|0.56|0.95|||||||
1668407|NCT01407276|3070666|Superiority or Other||GMR of Panel E:Panel F|0.74|||||2-Sided|90.0|0.57|0.96|||||||
1668408|NCT01407276|3070666|Superiority or Other||GMR of Panel E:Panel F|0.9|||||2-Sided|90.0|0.66|1.23|||||||
1668409|NCT01407276|3070666|Superiority or Other||GMR of Panel C:Panel D|1.13|||||2-Sided|90.0|0.91|1.41|||||||
1668410|NCT01407276|3070666|Superiority or Other||GMR of Panel A:Panel B|0.94|||||2-Sided|90.0|0.79|1.12|||||||
1668411|NCT01407276|3070667|Superiority or Other||GMR of Panel G:Panel H|1.97|||||2-Sided|90.0|1.46|2.66|||||||
1668412|NCT01407276|3070667|Superiority or Other||GMR or Panel G:Panel H|1.89|||||2-Sided|90.0|1.4|2.55|||||||
1668413|NCT01407276|3070667|Superiority or Other||GMR of Panel E:Panel F|1.56|||||2-Sided|90.0|1.32|1.85|||||||
1668414|NCT01407276|3070667|Superiority or Other||GMR of Panel C:Panel D|1.34|||||2-Sided|90.0|1.12|1.61|||||||
1668415|NCT01407276|3070667|Superiority or Other||GMR|0.94|||||2-Sided|90.0|0.8|1.11|||||||
1668416|NCT01406873|3070695|Superiority||||||<|0.01|||||||ANCOVA||||
1668417|NCT01406717|3070713|Other|||||||0.2984|||||||ANOVA||||
1668418|NCT01406717|3070714|Other|||||||0.7324|||||||ANOVA||||
1668419|NCT01406717|3070715|Other|||||||0.6098|||||||Mantel Haenszel||||
1668420|NCT01406717|3070716|Other|||||||0.0017|||||||ANOVA||||
1668421|NCT01406717|3070717|Other|||||||0.99|||||||ANOVA||||
1668422|NCT01406717|3070718|Other|||||||0.3813|||||||ANOVA||||
1668423|NCT01406717|3070719|Other|||||||0.4887|||||||ANOVA||||
1668424|NCT01406717|3070720|Other|||||||0.6318|||||||ANCOVA||||
1668425|NCT01406717|3070722|Other||||||<|0.0001|||||||Mantel Haenszel||||
1668426|NCT01406717|3070723|Other||ANCOVA|5.898|||||2-Sided|95.0|-6.7565|18.5535|||||||
1668427|NCT01406717|3070724|Other||ANCOVA|0.0002|||||2-Sided|95.0|-0.31377|0.31418|||||||
1668428|NCT01405937|3070746|Superiority or Other||||||<|0.001||||||The Type-I error rate over the multiple tests comparisons was controlled by the Hochberg testing procedure.|exact test for binomial proportion|||The null hypothesis that the percentage of participants achieving SVR24 of vaniprevir treatment was 20% versus the alternative that the percentage of participants achieving SVR24 of vaniprevir treatment was over 20% was tested.|
1668429|NCT01405937|3070746|Superiority or Other||||||<|0.001||||||The Type-I error rate over the multiple tests comparisons was controlled by the Hochberg testing procedure.|exact test for binomial proportion|||The null hypothesis that the percentage of participants achieving SVR24 of vaniprevir treatment was 20% versus the alternative that the percentage of participants achieving SVR24 of vaniprevir treatment was over 20% was tested.|
1668430|NCT01405911|3070755|Other||Difference in Least Squares Means|1.3||||0.469|2-Sided|95.0|-2.22|4.82|||Constrained Longitudinal Data Analysis||||
1668431|NCT01405911|3070755|Other||Difference in Least Squares Means|-16.41|||<|0.001|2-Sided|95.0|-20.32|-12.5|||Constrained Longitudinal Data Analysis||||
1668432|NCT01405911|3070755|Other||Difference in Least Squares Means|-17.7|||<|0.001|2-Sided|95.0|-21.55|-13.86|||Constrained Longitudinal Data Analysis||||
1668433|NCT01405911|3070756|Other||Difference in Least Squares Means|-1.97||||0.143|2-Sided|95.0|-4.61|0.67|||Constrained Longitudinal Data Analysis||||
1668434|NCT01405911|3070756|Other||Difference in Least Squares Means|-9.08|||<|0.001|2-Sided|95.0|-11.82|-6.33|||Constrained Longitudinal Data Analysis||||
1668435|NCT01405911|3070756|Other||Difference in Least Squares Means|-7.11|||<|0.001|2-Sided|95.0|-9.85|-4.36|||Constrained Longitudinal Data Analysis||||
1668436|NCT01405768|3070801|Superiority or Other|||||||0.13|||||||Wilcoxon (Mann-Whitney)||||
1668437|NCT01405768|3070803|Superiority or Other|||||||0.13|||||||Wilcoxon (Mann-Whitney)||||
1668438|NCT01405469|3070824|Superiority or Other (legacy)||Mean Difference (Net)|-7.44|Standard Deviation|2.66|<|0.001||95.0|||||t-test, 2 sided|||this pilot study was created ro evaluate sample size for the following multicenter study, based on manometric outcomes. Mean values between baseline and follow-up were compared using Student ’ s t -test for paired samples. P values less then 0.05, two-sided, were considered significant.R 2.13.1(R Development Core Team (2011). Subgroups (partial vs. complete myotomy) were compared using an analysis of variance test adjusted for initial values.|
1668439|NCT01405456|3070827|Superiority|||||||0.04|||||||t-test, 2 sided|||Change in MCP-1 from baseline to 6 months|
1668919|NCT01400932|3071291|Superiority or Other||||||<|0.001||||||Week 1; IL|ANCOVA||||
1668440|NCT01405456|3070828|Superiority|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change in IL-6 from baseline to 6 months|
1668441|NCT01405456|3070829|Superiority|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Change in Adiponectin from baseline to 6 months|
1668442|NCT01405456|3070830|Superiority|||||||0.37|||||||t-test, 2 sided|||Change in Plasminogen Activator Inhibitor 1 from baseline to 6 months|
1668443|NCT01405456|3070831|Superiority|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Change in C-Reactive Protein from baseline to 6 months|
1668444|NCT01405456|3070832|Superiority|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Change in Hemoglobin A1c from baseline to 6 months|
1668445|NCT01405456|3070833|Superiority|||||||0.07|||||||t-test, 2 sided|||Mean serum measurements of Potassium|
1668446|NCT01405456|3070834|Superiority|||||||0.44|||||||Wilcoxon (Mann-Whitney)|||Change in Flow Mediated Vasodilation (maximum percentage) from baseline to 6 months|
1668447|NCT01405456|3070835|Superiority|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Change in Intramyocellular Lipid of calf muscles as measured by magnetic resonance spectroscopy from baseline to 6 months|
1668448|NCT01405456|3070836|Superiority|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||Change in Liver Fat (Intrahepatic Lipid) as measured by magnetic resonance spectroscopy from baseline to 6 months|
1668449|NCT01405456|3070837|Superiority|||||||0.42|||||||Wilcoxon (Mann-Whitney)|||Change in Visceral Adipose Tissue area as measured by magnetic resonance imaging of the abdomen from baseline to 6 months|
1668450|NCT01405456|3070838|Superiority|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||Change in Insulin Stimulated Glucose Uptake measured during euglycemic hyperinsulinemic clamp procedure from baseline to 6 months|
1668451|NCT01405313|3070839|Non-Inferiority or Equivalence|Non-inferiority|Mean Difference (Final Values)|3.0||||0.016|2-Sided|80.0|||||t-test, 1 sided||||
1668452|NCT01405313|3070840|Non-Inferiority or Equivalence|Non-inferiority|Mean Difference (Final Values)|2.5||||0.022|2-Sided|80.0|||||t-test, 1 sided||||
1668453|NCT01405196|3070841|Superiority||LS mean difference|0.6|||||2-Sided|90.0|-2.68|3.88||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668454|NCT01405196|3070841|Superiority||LS mean difference|0.91|||||2-Sided|90.0|-2.38|4.19||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668455|NCT01405196|3070841|Superiority||LS mean difference|3.6|||||2-Sided|90.0|0.32|6.89||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668456|NCT01405196|3070841|Superiority||LS mean difference|1.33|||||2-Sided|90.0|-1.96|4.61||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668457|NCT01405196|3070841|Superiority||LS mean difference|0.97|||||2-Sided|90.0|-2.31|4.26||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668458|NCT01405196|3070841|Superiority||LS mean difference|1.69|||||2-Sided|90.0|-1.61|4.99||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668459|NCT01405196|3070841|Superiority||LS mean difference|1.69|||||2-Sided|90.0|-1.65|5.03||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668460|NCT01405196|3070841|Superiority||LS mean difference|1.95|||||2-Sided|90.0|-1.39|5.29||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668461|NCT01405196|3070841|Superiority||LS mean difference|3.88|||||2-Sided|90.0|0.54|7.22||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668462|NCT01405196|3070841|Superiority||LS mean difference|2.81|||||2-Sided|90.0|-0.53|6.15||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668463|NCT01405196|3070841|Superiority||LS mean difference|1.95|||||2-Sided|90.0|-1.38|5.29||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668464|NCT01405196|3070841|Superiority||LS mean difference|2.08|||||2-Sided|90.0|-1.26|5.42||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the Least Square (LS) mean difference from that model.|
1668465|NCT01405196|3070843|Superiority||LS mean difference|2.59|||||2-Sided|90.0|0.11|5.08||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668466|NCT01405196|3070843|Superiority||LS mean difference|2.34|||||2-Sided|90.0|-0.15|4.82||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668467|NCT01405196|3070843|Superiority||LS mean difference|2.01|||||2-Sided|90.0|-0.47|4.5||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668468|NCT01405196|3070843|Superiority||LS mean difference|1.84|||||2-Sided|90.0|-0.65|4.32||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668469|NCT01405196|3070843|Superiority||LS mean difference|2.68||||||90.0|0.2|5.17||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668470|NCT01405196|3070843|Superiority||LS mean difference|1.96|||||2-Sided|90.0|-0.53|4.46||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668471|NCT01405196|3070843|Superiority||LS mean difference|3.03||||||90.0|0.5|5.56||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668472|NCT01405196|3070843|Superiority||LS mean difference|3.1|||||2-Sided|90.0|0.57|5.63||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668473|NCT01405196|3070843|Superiority||LS mean difference|3.77|||||2-Sided|90.0|1.24|6.3||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668474|NCT01405196|3070843|Superiority||LS mean difference|3.23|||||2-Sided|90.0|0.7|5.76||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668475|NCT01405196|3070843|Superiority||LS mean difference|3.36|||||2-Sided|90.0|0.84|5.89||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668476|NCT01405196|3070843|Superiority||LS mean difference|2.67|||||2-Sided|90.0|0.14|5.2||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668477|NCT01405196|3070843|Superiority||LS mean difference|-0.71|||||2-Sided|90.0|-3.72|2.3||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668478|NCT01405196|3070843|Superiority||LS mean difference|-1.58|||||2-Sided|90.0|-4.58|1.43||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668479|NCT01405196|3070843|Superiority||LS mean difference|-0.16|||||2-Sided|90.0|-3.17|2.85||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668480|NCT01405196|3070843|Superiority||LS mean difference|-0.02|||||2-Sided|90.0|-3.03|2.99||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668481|NCT01405196|3070843|Superiority||LS mean difference|-0.09|||||2-Sided|90.0|-3.09|2.92||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668482|NCT01405196|3070843|Superiority||LS mean difference|0.0|||||2-Sided|90.0|-3.03|3.03||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668483|NCT01405196|3070843|Superiority||LS mean difference|0.09|||||2-Sided|90.0|-2.98|3.15||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668484|NCT01405196|3070843|Superiority||LS mean difference|1.2|||||2-Sided|90.0|-1.86|4.26||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668485|NCT01405196|3070843|Superiority||LS mean difference|1.78|||||2-Sided|90.0|-1.28|4.84||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668486|NCT01405196|3070843|Superiority||LS mean difference|1.28|||||2-Sided|90.0|-1.78|4.34||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668487|NCT01405196|3070843|Superiority||LS mean difference|-0.48|||||2-Sided|90.0|-3.54|2.58||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668488|NCT01405196|3070843|Superiority||LS mean difference|0.53|||||2-Sided|90.0|-2.53|3.59||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668489|NCT01405196|3070844|Superiority||LS mean difference|1.44|||||2-Sided|90.0|-5.24|8.13||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668490|NCT01405196|3070844|Superiority||LS mean difference|2.99|||||2-Sided|90.0|-3.7|9.68||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668491|NCT01405196|3070844|Superiority||LS mean difference|3.67||||||90.0|-3.02|10.35||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668492|NCT01405196|3070844|Superiority||LS mean difference|-0.78|||||2-Sided|90.0|-7.47|5.91||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668493|NCT01405196|3070844|Superiority||LS mean difference|3.93|||||2-Sided|90.0|-2.75|10.62||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668494|NCT01405196|3070844|Superiority||LS mean difference|1.33|||||2-Sided|90.0|-5.4|8.05||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668495|NCT01405196|3070844|Superiority||LS mean difference|4.33|||||2-Sided|90.0|-2.47|11.13||||||Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668496|NCT01405196|3070844|Superiority||LS mean difference|7.12|||||2-Sided|90.0|0.32|13.92||||||Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668497|NCT01405196|3070844|Superiority||LS mean difference|7.85|||||2-Sided|90.0|1.05|14.66||||||Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668498|NCT01405196|3070844|Superiority||LS mean difference|3.55|||||2-Sided|90.0|-3.25|10.36||||||Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668499|NCT01405196|3070844|Superiority||LS mean difference|3.92||||||90.0|-2.88|10.72||||||Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668500|NCT01405196|3070844|Superiority||LS mean difference|0.47||||||90.0|-6.33|7.27||||||Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668501|NCT01405196|3070845|Superiority||LS mean difference|2.59|||||2-Sided|90.0|0.11|5.08||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668502|NCT01405196|3070845|Superiority||LS mean difference|2.34|||||2-Sided|90.0|-0.15|4.82||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668503|NCT01405196|3070845|Superiority||LS mean difference|2.01|||||2-Sided|90.0|-0.47|4.5||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668504|NCT01405196|3070845|Superiority||LS mean difference|1.84|||||2-Sided|90.0|-0.65|4.32||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668505|NCT01405196|3070845|Superiority||LS mean difference|2.68||||||90.0|0.2|5.17||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668506|NCT01405196|3070845|Superiority||LS mean difference|1.96|||||2-Sided|90.0|-0.53|4.46||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668507|NCT01405196|3070845|Superiority||LS mean difference|3.03||||||90.0|0.5|5.56||||||PCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668508|NCT01405196|3070845|Superiority||LS mean difference|3.1|||||2-Sided|90.0|0.57|5.63||||||PCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668920|NCT01400932|3071292|Superiority or Other||||||<|0.001||||||Week 8|ANCOVA||||
1668509|NCT01405196|3070845|Superiority||LS mean difference|3.77|||||2-Sided|90.0|1.24|6.3||||||PCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668510|NCT01405196|3070845|Superiority||LS mean difference|3.23|||||2-Sided|90.0|0.7|5.76||||||PCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668511|NCT01405196|3070845|Superiority||LS mean difference|3.36|||||2-Sided|90.0|0.84|5.89||||||PCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668512|NCT01405196|3070845|Superiority||LS mean difference|2.67|||||2-Sided|90.0|0.14|5.2||||||PCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668513|NCT01405196|3070845|Superiority||LS mean difference|-0.71|||||2-Sided|90.0|-3.72|2.3||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668514|NCT01405196|3070845|Superiority||LS mean difference|-1.58|||||2-Sided|90.0|-4.58|1.43||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668515|NCT01405196|3070845|Superiority||LS mean difference|-0.16|||||2-Sided|90.0|-3.17|2.85||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668516|NCT01405196|3070845|Superiority||LS mean difference|-0.02|||||2-Sided|90.0|-3.03|2.99||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668517|NCT01405196|3070845|Superiority||LS mean difference|-0.09|||||2-Sided|90.0|-3.09|2.92||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668518|NCT01405196|3070845|Superiority||LS mean difference|0.0|||||2-Sided|90.0|-3.03|3.03||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668519|NCT01405196|3070845|Superiority||LS mean difference|0.09|||||2-Sided|90.0|-2.98|3.15||||||MCS Week 24: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668520|NCT01405196|3070845|Superiority||LS mean difference|1.2|||||2-Sided|90.0|-1.86|4.26||||||MCS Week 20: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668521|NCT01405196|3070845|Superiority||LS mean difference|1.78|||||2-Sided|90.0|-1.28|4.84||||||MCS Week 16: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668522|NCT01405196|3070845|Superiority||LS mean difference|1.28|||||2-Sided|90.0|-1.78|4.34||||||MCS Week 12: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668523|NCT01405196|3070845|Superiority||LS mean difference|-0.48|||||2-Sided|90.0|-3.54|2.58||||||MCS Week 8: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668524|NCT01405196|3070845|Superiority||LS mean difference|0.53|||||2-Sided|90.0|-2.53|3.59||||||MCS Week 4: Analysis was done using the ANCOVA model; CI parameter being the LS mean difference from that model.|
1668525|NCT01405196|3070847|Superiority||LS mean difference|-2.34|||||2-Sided|90.0|-8.39|3.71||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.|
1668526|NCT01405196|3070847|Superiority||LS mean difference|-0.34|||||2-Sided|90.0|-6.39|5.71||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.|
1668527|NCT01405196|3070847|Superiority||LS mean difference|0.1|||||2-Sided|90.0|-5.96|6.15||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.|
1668528|NCT01405196|3070847|Superiority||LS mean difference|1.5|||||2-Sided|90.0|-4.56|7.55||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.|
1668529|NCT01405196|3070847|Superiority||LS mean difference|-4.2||||||90.0|-10.25|1.85||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.|
1668530|NCT01405196|3070847|Superiority||LS mean difference|1.92||||||90.0|-4.17|8.01||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.|
1668531|NCT01405196|3070847|Superiority||LS mean difference|3.95||||||90.0|-2.24|10.15||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.|
1668532|NCT01405196|3070847|Superiority||LS mean difference|4.59|||||2-Sided|90.0|-1.61|10.79||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.|
1668533|NCT01405196|3070847|Superiority||LS mean difference|1.69|||||2-Sided|90.0|-4.51|7.88||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.|
1668534|NCT01405196|3070847|Superiority||LS mean difference|2.62|||||2-Sided|90.0|-3.57|8.82||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.|
1668535|NCT01405196|3070847|Superiority||LS mean difference|-2.02||||||90.0|-8.21|4.18||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.|
1668536|NCT01405196|3070847|Superiority||LS mean difference|3.63||||||90.0|-2.56|9.83||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline tender score.|
1668537|NCT01405196|3070848|Superiority||LS Mean difference|2.66|||||2-Sided|90.0|-4.48|9.8||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668830|NCT01401543|3071161|Superiority or Other||Geometric LS Mean Ratio|0.99|||||2-Sided|90.0|0.93|1.05|||||||
1668538|NCT01405196|3070848|Superiority||LS Mean difference|-2.64|||||2-Sided|90.0|-9.61|4.32||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668539|NCT01405196|3070848|Superiority||LS Mean difference|-4.94|||||2-Sided|90.0|-11.91|2.03||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668540|NCT01405196|3070848|Superiority||LS Mean difference|3.14|||||2-Sided|90.0|-3.67|9.94||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668541|NCT01405196|3070848|Superiority||LS Mean difference|2.56|||||2-Sided|90.0|-4.29|9.4||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668542|NCT01405196|3070848|Superiority||LS Mean difference|3.97|||||2-Sided|90.0|-2.95|10.9||||||Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668543|NCT01405196|3070848|Superiority||LS Mean difference|-2.81|||||2-Sided|90.0|-9.62|4.0||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668544|NCT01405196|3070848|Superiority||LS Mean difference|2.07|||||2-Sided|90.0|-4.7|8.84||||||Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668545|NCT01405196|3070848|Superiority||LS Mean difference|1.98|||||2-Sided|90.0|-5.17|9.13||||||Week 24: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668546|NCT01405196|3070848|Superiority||LS Mean difference|-6.21|||||2-Sided|90.0|-13.37|0.94||||||Week 20: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668547|NCT01405196|3070848|Superiority||LS Mean difference|-2.89|||||2-Sided|90.0|-9.87|4.1||||||Week 16: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668548|NCT01405196|3070848|Superiority||LS Mean difference|-3.98|||||2-Sided|90.0|-11.04|3.07||||||Week 12: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668549|NCT01405196|3070848|Superiority||LS Mean difference|4.67|||||2-Sided|90.0|-2.22|11.57||||||Week 8: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668550|NCT01405196|3070848|Superiority||LS Mean difference|1.3|||||2-Sided|90.0|-5.71|8.32||||||Week 6: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668551|NCT01405196|3070848|Superiority||LS Mean difference|-1.39|||||2-Sided|90.0|-8.21|5.42||||||Week 4: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668552|NCT01405196|3070848|Superiority||LS mean difference|-5.41|||||2-Sided|90.0|-12.3|1.49||||||Week 2: Analysis was done using linear mixed effect model that included fixed factors of the stratification factors, treatment, visit, treatment by visit and baseline VAS.|
1668553|NCT01405196|3070860|Superiority||Odds Ratio (OR)|2.88||||0.192|2-Sided|90.0|0.39|21.3||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668554|NCT01405196|3070860|Superiority||Odds Ratio (OR)|2.81||||0.198|2-Sided|90.0|0.38|20.65||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||No worsening in PhGA: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668555|NCT01405196|3070860|Superiority||Odds Ratio (OR)|0.84||||0.625|2-Sided|90.0|0.34|2.08||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||>=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668556|NCT01405196|3070860|Superiority||Odds Ratio (OR)|1.59||||0.205|2-Sided|90.0|0.63|4.02||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||>=4 points reduction in SLEDAI score: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668557|NCT01405196|3070861|Superiority||Odds Ratio (OR)|2.03|||||2-Sided|90.0|0.82|5.06||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668558|NCT01405196|3070861|Superiority||Odds Ratio (OR)|2.95|||||2-Sided|90.0|1.18|7.41||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668559|NCT01405196|3070861|Superiority||Odds Ratio (OR)|1.67|||||2-Sided|90.0|0.66|4.21||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668560|NCT01405196|3070861|Superiority||Odds Ratio (OR)|2.8|||||2-Sided|90.0|1.1|7.12||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668904|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 1; IL|ANCOVA||||
1668561|NCT01405196|3070861|Superiority||Odds Ratio (OR)|1.82|||||2-Sided|90.0|0.74|4.46||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668562|NCT01405196|3070861|Superiority||Odds Ratio (OR)|2.36|||||2-Sided|90.0|0.95|5.88||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668563|NCT01405196|3070861|Superiority||Odds Ratio (OR)|1.31|||||2-Sided|90.0|0.55|3.1||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668564|NCT01405196|3070861|Superiority||Odds Ratio (OR)|1.01|||||2-Sided|90.0|0.42|2.45||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668565|NCT01405196|3070861|Superiority||Odds Ratio (OR)|0.93|||||2-Sided|90.0|0.39|2.23||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668566|NCT01405196|3070861|Superiority||Odds Ratio (OR)|0.81|||||2-Sided|90.0|0.33|1.96||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668567|NCT01405196|3070861|Superiority||Odds Ratio (OR)|1.04|||||2-Sided|90.0|0.41|2.65||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668568|NCT01405196|3070861|Superiority||Odds Ratio (OR)|1.34|||||2-Sided|90.0|0.53|3.35||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668569|NCT01405196|3070862|Superiority||Odds Ratio (OR)|1.0|||||2-Sided|90.0|0.4|2.46||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668570|NCT01405196|3070862|Superiority||Odds Ratio (OR)|2.22|||||2-Sided|90.0|0.89|5.55||||||Week 24: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668571|NCT01405196|3070862|Superiority||Odds Ratio (OR)|1.21|||||2-Sided|90.0|0.5|2.92||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668572|NCT01405196|3070862|Superiority||Odds Ratio (OR)|1.78|||||2-Sided|90.0|0.72|4.37||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668573|NCT01405196|3070862|Superiority||Odds Ratio (OR)|0.74|||||2-Sided|90.0|0.3|1.84||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668574|NCT01405196|3070862|Superiority||Odds Ratio (OR)|1.45|||||2-Sided|90.0|0.58|3.6||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668575|NCT01405196|3070862|Superiority||Odds Ratio (OR)|0.45|||||2-Sided|90.0|0.18|1.13||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668576|NCT01405196|3070862|Superiority||Odds Ratio (OR)|0.75|||||2-Sided|90.0|0.3|1.83||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668577|NCT01405196|3070862|Superiority||Odds Ratio (OR)|0.8|||||2-Sided|90.0|0.32|2.02||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668578|NCT01405196|3070862|Superiority||Odds Ratio (OR)|0.72|||||2-Sided|90.0|0.28|1.85||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668579|NCT01405196|3070862|Superiority||Odds Ratio (OR)|0.75|||||2-Sided|90.0|0.19|3.01||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668580|NCT01405196|3070862|Superiority||Odds Ratio (OR)|1.05|||||2-Sided|90.0|0.28|3.88||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668581|NCT01405196|3070863|Superiority||Odds Ratio (OR)|0.94|||||2-Sided|90.0|0.38|2.32||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668582|NCT01405196|3070863|Superiority||Odds Ratio (OR)|1.95|||||2-Sided|90.0|0.78|4.84||||||Week 20: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668636|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.24||||0.147|2-Sided|95.0|-0.09|0.57|||Repeated measure model|||Baseline peripheral blood eosinophil count < 300 cells/μL|
1668583|NCT01405196|3070863|Superiority||Odds Ratio (OR)|0.69|||||2-Sided|90.0|0.27|1.77||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668584|NCT01405196|3070863|Superiority||Odds Ratio (OR)|1.62|||||2-Sided|90.0|0.64|4.09||||||Week 16: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668585|NCT01405196|3070863|Superiority||Odds Ratio (OR)|0.44|||||2-Sided|90.0|0.16|1.16||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668586|NCT01405196|3070863|Superiority||Odds Ratio (OR)|0.89|||||2-Sided|90.0|0.35|2.24||||||Week 12: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668587|NCT01405196|3070863|Superiority||Odds Ratio (OR)|0.77|||||2-Sided|90.0|0.29|2.05||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668588|NCT01405196|3070863|Superiority||Odds Ratio (OR)|1.03|||||2-Sided|90.0|0.4|2.67||||||Week 8: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668589|NCT01405196|3070863|Superiority||Odds Ratio (OR)|1.54|||||2-Sided|90.0|0.31|7.71||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668590|NCT01405196|3070863|Superiority||Odds Ratio (OR)|2.77|||||2-Sided|90.0|0.62|12.4||||||Week 4: Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668591|NCT01405196|3070864|Superiority||Odds Ratio (OR)|0.96||||0.528|2-Sided|90.0|0.38|2.41||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668592|NCT01405196|3070864|Superiority||Odds Ratio (OR)|2.23||||0.076|2-Sided|90.0|0.89|5.62||P-value was displayed without adjusting for multiplicity.|Mixed Models Analysis|||Point estimates of the Odds ratio (ORs) as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit.|
1668593|NCT01405053|3070874|Superiority||LS Mean difference|2.601|Standard Error of the Mean|6.558||0.6928|2-Sided|95.0|-10.5|15.7|||ANCOVA|||The primary statistical model for comparing the 2 treatment groups was an analysis of covariance (ANCOVA) mixed model for repeated measures with baseline score, age, and sex as covariates, and treatment, week, and treatment by week interaction as factors.|
1668594|NCT01405027|3070879|Superiority or Other|||||||0.4864|||||||ANOVA||||
1668595|NCT01404988|3070880|Superiority or Other|||||||0.16|||||||Fisher Exact||||
1668596|NCT01404988|3070880|Superiority or Other|||||||0.6||||||For this pilot study, type 1 error was set at 5%|Fisher Exact||||
1668597|NCT01404988|3070881|Superiority or Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)||||
1668598|NCT01404988|3070881|Superiority or Other|||||||0.03||||||For this pilot study, the type 1 error was set at 5%|Wilcoxon (Mann-Whitney)||||
1668599|NCT01404988|3070882|Superiority or Other|||||||0.77|||||||Wilcoxon (Mann-Whitney)||||
1668600|NCT01404988|3070882|Superiority or Other|||||||0.3||||||For this pilot study, the type 1 error was set at 5%|Wilcoxon (Mann-Whitney)||||
1668601|NCT01404988|3070883|Superiority or Other|||||||0.2|||||||Wilcoxon (Mann-Whitney)||||
1668602|NCT01404988|3070883|Superiority or Other|||||||0.1||||||For this pilot study, the Type 1 error was set at 5%|Wilcoxon (Mann-Whitney)||||
1668603|NCT01404923|3070886|Superiority or Other||Mean Difference (Final Values)|5.4||||0.0008|2-Sided||||||ANCOVA||||
1668604|NCT01404429|3070908|Superiority or Other||Mean Difference (Final Values)|0.14||||0.6|2-Sided|95.0|-0.26|0.54|||t-test, 2 sided||||
1668605|NCT01404325|3070935|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1668606|NCT01404312|3070940|Superiority||Hazard Ratio (HR)|1.396||||0.2802|2-Sided|95.0|0.762|2.559||Not adjusted for multiple comparisons|Hazard Ratio||Hazard ratio given as: Arm B hazard / Arm A hazard, i.e. HR > 1 favors arm A|"Competing risk analysis using the Fine-Gray model, treating TB-related deaths as competing risks, and other deaths including deaths of unknown cause as the event of interest.~H0: Hazard Ratio for Arm A vs Arm B = 1"|
1668607|NCT01404312|3070941|Superiority|||||||0.3078||||||Not adjusted for multiple comparisons|Log Rank|||H0: Survival curve Arm A = Survival curve Arm B|
1668608|NCT01404312|3070942|Superiority||Odds Ratio (OR)|2.093|||||2-Sided|95.0|1.315|3.332|||||"Estimate given as: Odds of being in higher category (more stringent management due to toxicity) for Arm B compared with arm A~Not adjusted for multiple comparisons."|"Odds ratio of being in higher category estimated from proportional odds model~H0: Odds ratio of being in higher category for Arm A vs Arm B = 1"|
1668609|NCT01404312|3070943|Superiority||Risk Difference (RD)|-0.0058||||0.405|2-Sided|95.0|-0.019|0.007||Not adjusted for multiple comparisons|Fisher Exact||Estimate given as: Proportion Arm A - Proportion Arm B|"Comparison of the proportion of participants with any targeted adverse event occurrence between arms A and B.~H0: Proportion of participants with a targeted adverse event in Arm A = Proportion of participants with a targeted adverse event in Arm B."|
1668610|NCT01404312|3070944|Superiority||Risk Difference (RD)|-0.016||||0.073|2-Sided|95.0|-0.035|0.002||Not adjusted for multiple comparisons.|Fisher Exact||Estimate given as: Proportion Arm A - Proportion Arm B|"Comparison of the proportion of participants with any SAE occurrence between arms A and B.~H0: Proportion of participants with SAE in Arm A = Proportion of participants with SAE in Arm B."|
1668905|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 12; Total|ANCOVA||||
1668611|NCT01404312|3070945|Non-Inferiority|"Non-inferiority margin: 1.25 events per 100 person-years.~Sample size determination was based on the assumption of a primary endpoint rate of 2.0/100 person-years, with a one-sided 0.025 alpha level, and targeting at least 90% power. This required a sample size of approximately 2500. The sample size was adjusted upwards to account for loss to follow-up, interim monitoring, and to allow for subgroup analyses with reasonable power."|Incidence Rate Difference|-0.0231|||||2-Sided|95.1|-0.346|0.3|||||"Estimate given as Incidence rate in Arm A - Incidence Rate in Arm B (negative favors Arm A).~Incidence rate units: Events per 100 person-years"|Mantel-Haenszel method used for estimating standardized incidence rate in each arm and incidence rate difference.|
1668612|NCT01403805|3070971|Superiority or Other|||||||0.05|||||||Fisher Exact|||The results are expressed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher’s test.|
1668613|NCT01403805|3070972|Superiority or Other||||||<|0.001||||||Fisher’s test 'Vaccine' versus 'Oral Care and Vaccines' and 'phumonia' and 'not pneumonia'|Fisher Exact|||The results were analyzed as means ± standard deviation (SD) or numbers (%). Differences between the 2 nursing homes were compared using Fisher’s test.|
1668614|NCT01403051|3071003|Superiority or Other|||||||0.001||||||2-sided test with type I error rate of 5%, not adjusted for multiple comparisons.|Stratified Wilcoxon rank sum test|Stratified Wilcoxon rank sum test for differences between the two treatment groups, stratified by the screening 25-OH vitamin (<=20 vs. >20 ng/mL)||The study was sized to have 80% power to detect a 2 % difference in BMD of the hip from baseline to week 48.|
1668615|NCT01402986|3071012|Superiority or Other||Rate Ratio|0.87||||0.531|2-Sided|95.0|0.57|1.34|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Without chronic OCS use|
1668616|NCT01402986|3071012|Superiority or Other||Rate Ratio|0.79||||0.243||95.0|0.53|1.18|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Without chronic OCS use|
1668617|NCT01402986|3071012|Superiority or Other||Rate Ratio|1.29||||0.506|2-Sided|95.0|0.61|2.74|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|With chronic OCS use|
1668618|NCT01402986|3071012|Superiority or Other||Rate Ratio|1.2||||0.614|2-Sided|95.0|0.59|2.46|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|With chronic OCS use|
1668619|NCT01402986|3071013|Superiority or Other||Rate Ratio|1.07||||0.794|2-Sided|95.0|0.66|1.74|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Non-atopic asthma|
1668620|NCT01402986|3071013|Superiority or Other||Rate Ratio|0.71||||0.25|2-Sided|95.0|0.4|1.27|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Non-atopic asthma|
1668621|NCT01402986|3071013|Superiority or Other||Rate Ratio|0.83||||0.457|2-Sided|95.0|0.52|1.35|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Atopic asthma|
1668622|NCT01402986|3071013|Superiority or Other||Rate Ratio|0.95||||0.803|2-Sided|95.0|0.62|1.44|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Atopic asthma|
1668623|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.31||||0.03|2-Sided|95.0|0.03|0.6|||Repeated measure model|||Without chronic OCS use|
1668624|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.23||||0.105|2-Sided|95.0|-0.05|0.52|||Repeated measure model|||Without chronic OCS use|
1668625|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|-0.32||||0.327|2-Sided|95.0|-0.95|0.32|||Repeated measure model|||Chronic OCS use|
1668626|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.28||||0.398|2-Sided|95.0|-0.37|0.93|||Repeated measure model|||Chronic OCS use|
1668627|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.1||||0.648|2-Sided|95.0|-0.33|0.53|||Repeated measure model|||> 2 but < 6 asthma exacerbations in the past year|
1668628|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.24||||0.26|2-Sided|95.0|-0.18|0.67|||Repeated measure model|||> 2 but < 6 asthma exacerbations in the past year|
1668629|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.27||||0.097|2-Sided|95.0|-0.05|0.59|||Repeated measure model|||2 asthma exacerbations in the past year|
1668630|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.17||||0.292|2-Sided|95.0|-0.15|0.5|||Repeated measure model|||2 asthma exacerbations in the past year|
1668631|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.1||||0.533|2-Sided|95.0|-0.22|0.42|||Repeated measure model|||Baseline FEV1 reversibility < 12%|
1668632|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.01||||0.964|2-Sided|95.0|-0.31|0.33|||Repeated measure model|||Baseline FEV1 reversibility < 12%|
1668633|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.29||||0.226|2-Sided|95.0|-0.18|0.77|||Repeated measure model|||Baseline FEV1 reversibility >= 12%|
1668634|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.59||||0.02|2-Sided|95.0|0.1|1.09|||Repeated measure model|||Baseline FEV1 reversibility >= 12%|
1668635|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.35||||0.031|2-Sided|95.0|0.03|0.68|||Repeated measure model|||Baseline peripheral blood eosinophil count < 300 cells/μL|
1668906|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 8; Total|ANCOVA||||
1668637|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.07||||0.766|2-Sided|95.0|-0.37|0.51|||Repeated measure model|||Baseline peripheral blood eosinophil count >= 300 cells/μL|
1668638|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.19||||0.371|2-Sided|95.0|-0.23|0.62|||Repeated measure model|||Baseline peripheral blood eosinophil count >= 300 cells/μL|
1668639|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.38||||0.069|2-Sided|95.0|-0.03|0.79|||Repeated measure model|||Baseline peripheral blood eosinophil count < 150 cells/μL|
1668640|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.18||||0.406|2-Sided|95.0|-0.24|0.6|||Repeated measure model|||Baseline peripheral blood eosinophil count < 150 cells/μL|
1668641|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.16||||0.342|2-Sided|95.0|-0.17|0.49|||Repeated measure model|||Baseline peripheral blood eosinophil count >=150 cells/μL|
1668642|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.17||||0.295|2-Sided|95.0|-0.15|0.49|||Repeated measure model|||Baseline peripheral blood eosinophil count >=150 cells/μL|
1668643|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|-0.07||||0.674|2-Sided|95.0|-0.42|0.27|||Repeated measure model|||Th2 low|
1668644|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|-0.11||||0.54|2-Sided|95.0|-0.47|0.25|||Repeated measure model|||Th2 low|
1668645|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.3||||0.116|2-Sided|95.0|-0.08|0.68|||Repeated measure model|||Th2 high|
1668646|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.31||||0.102|2-Sided|95.0|-0.06|0.69|||Repeated measure model|||Th2 high|
1668647|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|-0.12||||0.404|2-Sided|95.0|-0.4|0.16|||Repeated measure model|||Baseline serum periostin < 75th percentile|
1668648|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|-0.1||||0.512|2-Sided|95.0|-0.38|0.19|||Repeated measure model|||Baseline serum periostin < 75th percentile|
1668649|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|-0.07||||0.775|2-Sided|95.0|-0.56|0.42|||Repeated measure model|||Baseline serum periostin >=75th percentile|
1668650|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|-0.37||||0.127|2-Sided|95.0|-0.84|0.11|||Repeated measure model|||Baseline serum periostin >=75th percentile|
1668651|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.29||||0.303|2-Sided|95.0|-0.26|0.84|||Repeated measure model|||Baseline serum periostin < 25th percentile|
1668652|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.25||||0.387|2-Sided|95.0|-0.32|0.81|||Repeated measure model|||Baseline serum periostin < 25th percentile|
1668653|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.14||||0.379|2-Sided|95.0|-0.17|0.44|||Repeated measure model|||Baseline serum periostin >= 25th percentile|
1668654|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.17||||0.262||95.0|-0.13|0.47|||Repeated measure model|||Baseline serum periostin >= 25th percentile|
1668655|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.26||||0.166|2-Sided|95.0|-0.11|0.63|||Repeated measure model|||Baseline serum periostin < median|
1668656|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.19||||0.315|2-Sided|95.0|-0.18|0.56|||Repeated Measure Model|||Baseline serum periostin < median|
1668657|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.16||||0.397|2-Sided|95.0|-0.21|0.53|||Repeated measure model|||Baseline serum periostin >= median|
1668658|NCT01402986|3071014|Superiority or Other||Difference of LS-mean|0.23||||0.211|2-Sided|95.0|-0.13|0.6|||Repeated measure model|||Baseline serum periostin >= median|
1668659|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.19||||0.165|2-Sided|95.0|-0.45|0.08|||Repeated measure model|||Without chronic OCS use|
1668660|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.17||||0.198|2-Sided|95.0|-0.43|0.09|||Repeated measure model|||Without chronic OCS use|
1668661|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|0.15||||0.613|2-Sided|95.0|-0.44|0.75|||Repeated measure model|||Chronic OCS use|
1668662|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.37||||0.226|2-Sided|95.0|-0.97|0.23|||Repeated measure model|||Chronic OCS use|
1668663|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.01||||0.974|2-Sided|95.0|-0.43|0.42|||Repeated measure model|||> 2 but < 6 asthma exacerbations in the past year|
1668664|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.14||||0.513|2-Sided|95.0|-0.56|0.28|||Repeated measure model|||> 2 but < 6 asthma exacerbations in the past year|
1668665|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.18||||0.226|2-Sided|95.0|-0.47|0.11|||Repeated measure model|||2 asthma exacerbations in the past year|
1668666|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.19||||0.198|2-Sided|95.0|-0.49|0.1|||Repeated measure model|||2 asthma exacerbations in the past year|
1668667|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|0.02||||0.905|2-Sided|95.0|-0.28|0.32|||Repeated measure model|||Baseline FEV1 reversibility < 12%|
1668668|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.07||||0.652|2-Sided|95.0|-0.37|0.23|||Repeated measure model|||Baseline FEV1 reversibility < 12%|
1668669|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.37||||0.104|2-Sided|95.0|-0.82|0.08|||Repeated measure model|||Baseline FEV1 reversibility >= 12%|
1668670|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.44||||0.055|2-Sided|95.0|-0.89|0.01|||Repeated measure model|||Baseline FEV1 reversibility >= 12%|
1668671|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.2||||0.203|2-Sided|95.0|-0.5|0.11|||Repeated measure model|||Baseline peripheral blood eosinophil count < 300 cells/μL|
1668672|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.03||||0.855|2-Sided|95.0|-0.35|0.29|||Repeated measure model|||Baseline peripheral blood eosinophil count < 300 cells/μL|
1668673|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.2||||0.348|2-Sided|95.0|-0.61|0.21|||Repeated measure model|||Baseline peripheral blood eosinophil count >= 300 cells/μL|
1668674|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.47||||0.019|2-Sided|95.0|-0.87|-0.08|||Repeated measure model|||Baseline peripheral blood eosinophil count >= 300 cells/μL|
1668907|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 4; Total|ANCOVA||||
1668675|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.12||||0.559|2-Sided|95.0|-0.53|0.28|||Repeated measure model|||Baseline peripheral blood eosinophil count < 150 cells/μL|
1668676|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.08||||0.725|2-Sided|95.0|-0.51|0.36|||Repeated measure model|||Baseline peripheral blood eosinophil count < 150 cells/μL|
1668677|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.17||||0.271|2-Sided|95.0|-0.48|0.13|||Repeated measure model|||Baseline peripheral blood eosinophil count >= 150 cells/μ|
1668678|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.22||||0.154|2-Sided|95.0|-0.52|0.08|||Repeated measure model|||Baseline peripheral blood eosinophil count >= 150 cells/μL|
1668679|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.07||||0.674|2-Sided|95.0|-0.42|0.27|||Repeated measure model|||Th2 low|
1668680|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.11||||0.54|2-Sided|95.0|-0.47|0.25|||Repeated measure model|||Th2 low|
1668681|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.25||||0.161|2-Sided|95.0|-0.6|0.1|||Repeated measure model|||Th2 high|
1668682|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.24||||0.181|2-Sided|95.0|-0.59|0.11|||Repeated measure model|||Th2 high|
1668683|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.12||||0.404|2-Sided|95.0|-0.4|0.16|||Repeated measure model|||Baseline serum periostin < 75th percentile|
1668684|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.1||||0.512|2-Sided|95.0|-0.38|0.19|||Repeated measure model|||Baseline serum periostin < 75th percentile|
1668685|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.07||||0.775|2-Sided|95.0|-0.56|0.42|||Repeated measure model|||Baseline serum periostin >= 75th percentile|
1668686|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.37||||0.127|2-Sided|95.0|-0.84|0.11|||Repeated measure model|||Baseline serum periostin >= 75th percentile|
1668687|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.29||||0.259|2-Sided|95.0|-0.81|0.22|||Repeated measure model|||Baseline serum periostin < 25th percentile|
1668688|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.23||||0.374|2-Sided|95.0|-0.74|0.28|||Repeated measure model|||Baseline serum periostin < 25th percentile|
1668689|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.01||||0.928|2-Sided|95.0|-0.29|0.27|||Repeated measure model|||Baseline serum periostin>= 25th percentile|
1668690|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.13||||0.343|2-Sided|95.0|-0.41|0.14|||Repeated measure model|||Baseline serum periostin>= 25th percentile|
1668691|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.28||||0.127|2-Sided|95.0|-0.64|0.08|||Repeated measure model|||Baseline serum periostin < median|
1668692|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.01||||0.936|2-Sided|95.0|-0.38|0.35|||Repeated measure model|||Baseline serum periostin < median|
1668693|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|0.05||||0.759|2-Sided|95.0|-0.28|0.38|||Repeated measure model|||Baseline serum periostin >= median|
1668694|NCT01402986|3071015|Superiority or Other||Difference of LS-mean|-0.24||||0.145|2-Sided|95.0|-0.57|0.08|||Repeated measure model|||Baseline serum periostin >= median|
1668695|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|1.28||||0.601|2-Sided|95.0|-3.51|6.06|||Repeated measure model|||Without chronic OCS use|
1668696|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|7.56||||0.002|2-Sided|95.0|2.76|12.36|||Repeated measure model|||Without chronic OCS use|
1668697|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|-1.46||||0.86|2-Sided|95.0|-17.76|14.84|||Repeated measure model|||Chronic OCS use|
1668698|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|0.87||||0.912|2-Sided|95.0|-14.7|16.44|||Repeated measure model|||Chronic OCS use|
1668699|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|-0.08||||0.986|2-Sided|95.0|-9.5|9.34|||Repeated measure model|||> 2 but < 6 asthma exacerbations in the past year|
1668700|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|6.34||||0.185|2-Sided|95.0|-3.06|15.75|||Repeated measure model|||> 2 but < 6 asthma exacerbations in the past year|
1668701|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|2.42||||0.361|2-Sided|95.0|-2.78|7.62|||Repeated measure model|||2 asthma exacerbations in the past year|
1668702|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|7.82||||0.003|2-Sided|95.0|2.64|13.01|||Repeated measure model|||2 asthma exacerbations in the past year|
1668703|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|2.79||||0.268|2-Sided|95.0|-2.15|7.74|||Repeated measure model|||Baseline FEV1 reversibility < 12%|
1668704|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|7.67||||0.002|2-Sided|95.0|2.76|12.59|||Repeated measure model|||Baseline FEV1 reversibility < 12%|
1668705|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|0.72||||0.887|2-Sided|95.0|-9.19|10.62|||Repeated measure model|||Baseline FEV1 reversibility >= 12%|
1668706|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|11.19||||0.029|2-Sided|95.0|1.15|21.23|||Repeated measure model|||Baseline FEV1 reversibility >= 12%|
1668707|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|0.72||||0.804|2-Sided|95.0|-5.01|6.46|||Baseline peripheral blood eosinophil cou|||Baseline peripheral blood eosinophil count < 300 cells/μ|
1668708|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|4.37||||0.144|2-Sided|95.0|-1.5|10.24|||Repeated measure model|||Baseline peripheral blood eosinophil count < 300 cells/μL|
1668709|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|5.23||||0.243|2-Sided|95.0|-3.56|14.02|||Repeated measure model|||Baseline peripheral blood eosinophil count >= 300 cells/μL|
1668710|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|13.75||||0.002|2-Sided|95.0|5.28|22.22|||Repeated measure model|||Baseline peripheral blood eosinophil count >= 300 cells/μL|
1668711|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|-0.72||||0.857|2-Sided|95.0|-8.63|7.18|||Repeated measure model|||Baseline peripheral blood eosinophil count < 150 cells/μL|
1668712|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|6.05||||0.159|2-Sided|95.0|-2.39|14.5|||Repeated measure model|||Baseline peripheral blood eosinophil count < 150 cells/μL|
1668713|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|4.25||||0.177|2-Sided|95.0|-1.92|10.43|||Repeated measure model|||Baseline peripheral blood eosinophil count >= 150 cells/μL|
1668714|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|8.83||||0.004|2-Sided|95.0|2.85|14.81|||Repeated measure model|||Baseline peripheral blood eosinophil count >= 150 cells/μL|
1668715|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|-1.18||||0.691|2-Sided|95.0|-6.99|4.64|||Repeated measure model|||Th2 low|
1668716|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|3.22||||0.292|2-Sided|95.0|-2.78|9.22|||Repeated measure model|||Th2 low|
1668717|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|3.91||||0.28|2-Sided|95.0|-3.19|11.02|||Repeated measure model|||Th2 high|
1668718|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|8.89||||0.014|2-Sided|95.0|1.84|15.94|||Repeated measure model|||Th2 high|
1668719|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|1.23||||0.635|2-Sided|95.0|-3.84|6.29|||Repeated measure model|||Baseline serum periostin < 75th percentile|
1668720|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|6.52||||0.013|2-Sided|95.0|1.41|11.64|||Repeated measure model|||Baseline serum periostin < 75th percentile|
1668721|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|0.7||||0.908|2-Sided|95.0|-11.19|12.59|||Repeated measure model|||Baseline serum periostin >= 75th percentile|
1668722|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|9.89||||0.09|2-Sided|95.0|-1.57|21.35|||Repeated measure model|||Baseline serum periostin >= 75th percentile|
1668723|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|8.58||||0.108|2-Sided|95.0|-1.91|19.07|||Repeated measure model|||Baseline serum periostin < 25th percentile|
1668724|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|6.24||||0.221|2-Sided|95.0|-3.8|16.27|||Repeated measure model|||Baseline serum periostin < 25th percentile|
1668725|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|-0.48||||0.863|2-Sided|95.0|-5.93|4.97|||Repeated measure model|||Baseline serum periostin >= 25th percentile|
1668726|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|7.12||||0.011|2-Sided|95.0|1.66|12.58|||Repeated measure model|||Baseline serum periostin >= 25th percentile|
1668727|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|1.09||||0.745|2-Sided|95.0|-5.48|7.66|||Repeated measure model|||Baseline serum periostin < median|
1668728|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|7.37||||0.028|2-Sided|95.0|0.8|13.95|||Repeated measure model|||Baseline serum periostin < median|
1668729|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|0.57||||0.874|2-Sided|95.0|-6.54|7.68|||Repeated measure model|||Baseline serum periostin >= median|
1668730|NCT01402986|3071016|Superiority or Other||Difference of LS-mean|6.79||||0.057|2-Sided|95.0|-0.21|13.79|||Repeated measure model|||Baseline serum periostin >= median|
1668731|NCT01402986|3071017|Superiority or Other||Rate Ratio|0.74||||0.661|2-Sided|95.0|0.19|2.85|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count <300 cells/mcgL|
1668732|NCT01402986|3071017|Superiority or Other||Rate Ratio|0.59||||0.51|2-Sided|95.0|0.12|2.84|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count <300 cells/mcgL|
1668733|NCT01402986|3071017|Superiority or Other||Rate Ratio|0.46||||0.241|2-Sided|95.0|0.13|1.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count >=300 cells/mcgL|
1668734|NCT01402986|3071017|Superiority or Other||Rate Ratio|0.48||||0.133|2-Sided|95.0|0.19|1.25|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count >=300 cells/mcgL|
1668735|NCT01402986|3071018|Superiority or Other||Rate Ratio|0.7||||0.576|2-Sided|95.0|0.2|2.47|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low|
1668736|NCT01402986|3071018|Superiority or Other||Rate Ratio|0.25||||0.105|2-Sided|95.0|0.05|1.34|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low|
1668737|NCT01402986|3071018|Superiority or Other||Rate Ratio|0.55||||0.299|2-Sided|95.0|0.18|1.7|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high|
1668738|NCT01402986|3071018|Superiority or Other||Rate Ratio|0.82||||0.698|2-Sided|95.0|0.31|2.19|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high|
1668739|NCT01402986|3071019|Superiority or Other||Rate Ratio|0.42||||0.148|2-Sided|95.0|0.13|1.36|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility <12%|
1668740|NCT01402986|3071019|Superiority or Other||Rate Ratio|0.49||||0.099|2-Sided|95.0|0.21|1.14|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility <12%|
1668741|NCT01402986|3071019|Superiority or Other||Rate Ratio|1.66||||0.473|2-Sided|95.0|0.41|6.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility >=12%|
1668742|NCT01402986|3071019|Superiority or Other||Rate Ratio|1.03||||0.975|2-Sided|95.0|0.14|7.67|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility >=12%|
1668743|NCT01402986|3071020|Superiority or Other||Rate Ratio|1.31||||0.594|2-Sided|95.0|0.48|3.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin < Median|
1668744|NCT01402986|3071020|Superiority or Other||Rate Ratio|1.18||||0.708|2-Sided|95.0|0.5|2.79|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin < Median|
1668745|NCT01402986|3071020|Superiority or Other||Rate Ratio|0.47||||0.197|2-Sided|95.0|0.15|1.48|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin >=Median|
1668746|NCT01402986|3071020|Superiority or Other||Rate Ratio|0.25||||0.046|2-Sided|95.0|0.06|0.98|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline Serum Periostin >=Median|
1668747|NCT01402986|3071021|Superiority or Other||Rate Ratio|1.39||||0.231|2-Sided|95.0|0.81|2.38|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|> 2 but < 6 asthma exacerbations in the past year|
1668748|NCT01402986|3071021|Superiority or Other||Rate Ratio|0.93||||0.792|2-Sided|95.0|0.56|1.56|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|> 2 but < 6 asthma exacerbations in the past year|
1668749|NCT01402986|3071021|Superiority or Other||Rate Ratio|0.6||||0.05|2-Sided|95.0|0.36|1.0|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|2 asthma exacerbations in the past year|
1668750|NCT01402986|3071021|Superiority or Other||Rate Ratio|0.94||||0.802|2-Sided|95.0|0.58|1.52|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|2 asthma exacerbations in the past year|
1668751|NCT01402986|3071022|Superiority or Other||Rate Ratio|1.07||||0.744|2-Sided|95.0|0.72|1.58|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted <=80%|
1668752|NCT01402986|3071022|Superiority or Other||Rate Ratio|0.86||||0.409|2-Sided|95.0|0.6|1.23|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted <=80%|
1668753|NCT01402986|3071022|Superiority or Other||Rate Ratio|1.06||||0.852|2-Sided|95.0|0.6|1.86|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted <=60%|
1668754|NCT01402986|3071022|Superiority or Other||Rate Ratio|0.91||||0.723|2-Sided|95.0|0.52|1.56|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1% predicted <=60%|
1668755|NCT01402986|3071023|Superiority or Other||Rate Ratio|0.97||||0.916|2-Sided|95.0|0.59|1.59|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility <12%|
1668756|NCT01402986|3071023|Superiority or Other||Rate Ratio|1.01||||0.947|2-Sided|95.0|0.66|1.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility <12%|
1668757|NCT01402986|3071023|Superiority or Other||Rate Ratio|0.76||||0.438|2-Sided|95.0|0.37|1.54|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility >=12%|
1668758|NCT01402986|3071023|Superiority or Other||Rate Ratio|0.66||||0.245|2-Sided|95.0|0.33|1.32|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline FEV1 reversibility >=12%|
1668801|NCT01402869|3071051|Non-Inferiority or Equivalence|Power of 80|||||=|0||||||P<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison|
1668759|NCT01402986|3071024|Superiority or Other||Rate Ratio|0.77||||0.264|2-Sided|95.0|0.49|1.22|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count <300 cells/mcgL|
1668760|NCT01402986|3071024|Superiority or Other||Rate Ratio|1.06||||0.793|2-Sided|95.0|0.67|1.68|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count <300 cells/mcgL|
1668761|NCT01402986|3071024|Superiority or Other||Rate Ratio|1.26||||0.463|2-Sided|95.0|0.68|2.36|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count >=300 cells/mcgL|
1668762|NCT01402986|3071024|Superiority or Other||Rate Ratio|0.81||||0.414|2-Sided|95.0|0.48|1.35|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count >=300 cells/mcgL|
1668763|NCT01402986|3071024|Superiority or Other||Rate Ratio|1.41||||0.311|2-Sided|95.0|0.73|2.71|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count <150 cells/mcgL|
1668764|NCT01402986|3071024|Superiority or Other||Rate Ratio|1.36||||0.331|2-Sided|95.0|0.73|2.52|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count <150 cells/mcgL|
1668765|NCT01402986|3071024|Superiority or Other||Rate Ratio|0.88||||0.586|2-Sided|95.0|0.54|1.41|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count >=150 cells/mcgL|
1668766|NCT01402986|3071024|Superiority or Other||Rate Ratio|0.82||||0.335|2-Sided|95.0|0.56|1.22|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline eosinophil count >=150 cells/mcgL|
1668767|NCT01402986|3071025|Superiority or Other||Rate Ratio|1.06||||0.813|2-Sided|95.0|0.66|1.7|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low|
1668768|NCT01402986|3071025|Superiority or Other||Rate Ratio|1.11||||0.685|2-Sided|95.0|0.67|1.84|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 Low|
1668769|NCT01402986|3071025|Superiority or Other||Rate Ratio|0.97||||0.922|2-Sided|95.0|0.56|1.68|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high|
1668770|NCT01402986|3071025|Superiority or Other||Rate Ratio|0.8||||0.365|2-Sided|95.0|0.5|1.29|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Th2 high|
1668771|NCT01402986|3071026|Superiority or Other||Rate Ratio|0.7||||0.088|2-Sided|95.0|0.47|1.05|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin < 75th Percentile|
1668772|NCT01402986|3071026|Superiority or Other||Rate Ratio|0.95||||0.804|2-Sided|95.0|0.64|1.41|||Poission regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin < 75th Percentile|
1668773|NCT01402986|3071026|Superiority or Other||Rate Ratio|1.51||||0.328|2-Sided|95.0|0.66|3.43|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin >= 75th Percentile|
1668774|NCT01402986|3071026|Superiority or Other||Rate Ratio|0.88||||0.716|2-Sided|95.0|0.44|1.75|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin >= 75th Percentile|
1668775|NCT01402986|3071026|Superiority or Other||Rate Ratio|0.91||||0.805|2-Sided|95.0|0.44|1.89|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin < 25th Percentile|
1668776|NCT01402986|3071026|Superiority or Other||Rate Ratio|1.26||||0.507|2-Sided|95.0|0.63|2.51|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin < 25th Percentile|
1668802|NCT01402869|3071051|Non-Inferiority or Equivalence|Power of 80|||||<|0.001||||||P<.05|least significant difference post hoc|||LSD post hoc pairwise comparison|
1668777|NCT01402986|3071026|Superiority or Other||Rate Ratio|1.02||||0.929|2-Sided|95.0|0.66|1.57|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin >= 25th Percentile|
1668778|NCT01402986|3071026|Superiority or Other||Rate Ratio|0.86||||0.455|2-Sided|95.0|0.58|1.28|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin >= 25th Percentile|
1668779|NCT01402986|3071026|Superiority or Other||Rate Ratio|0.91||||0.703|2-Sided|95.0|0.55|1.5|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin < median|
1668780|NCT01402986|3071026|Superiority or Other||Rate Ratio|1.13||||0.602|2-Sided|95.0|0.71|1.81|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin < median|
1668781|NCT01402986|3071026|Superiority or Other||Rate Ratio|0.95||||0.856|2-Sided|95.0|0.56|1.61|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin >= median|
1668782|NCT01402986|3071026|Superiority or Other||Rate Ratio|0.73||||0.19|2-Sided|95.0|0.46|1.17|||Poisson regression||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status, chronic OCS use and geographical region as the covariates.|Baseline serum periostin >= median|
1668783|NCT01402986|3071027|Superiority or Other||Hazard Ratio (HR)|0.8||||0.561|2-Sided|95.0|0.37|1.71|||Regression, Cox||||
1668784|NCT01402986|3071027|Superiority or Other||Hazard Ratio (HR)|0.79||||0.538|2-Sided|95.0|0.37|1.68|||Regression, Cox||||
1668785|NCT01402986|3071028|Superiority or Other||Hazard Ratio (HR)|0.8||||0.225|2-Sided|95.0|0.56|1.15|||Regression, Cox||||
1668786|NCT01402986|3071028|Superiority or Other||Hazard Ratio (HR)|0.81||||0.257|2-Sided|95.0|0.57|1.16|||Regression, Cox||||
1668787|NCT01402986|3071029|Superiority or Other||Rate Ratio|0.62||||0.27|2-Sided|95.0|0.27|1.44|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.|
1668788|NCT01402986|3071029|Superiority or Other||Rate Ratio|0.62||||0.293|2-Sided|95.0|0.26|1.51|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs >2 but =<6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.|
1668789|NCT01402986|3071046|Superiority or Other||Rate Ratio|1.02||||0.904|2-Sided|95.0|0.71|1.46|||Poisson regression|||The 95% CI for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 vs > 2 but =< 6), atopic asthma status (atopic/non-atopic), chronic OCS use (presence vs absence) and geographical region as the covariates.|
1668790|NCT01402986|3071046|Superiority or Other||Rate Ratio|0.94||||0.709|2-Sided|95.0|0.67|1.31|||Poisson regression|||The 95 percent (%) confidence interval (CI) for rate ratio were estimated from the Poisson regression with treatment group, age, gender, number of exacerbations in past year (2 versus [vs] more than [>] 2 but less than or equal to [=<] 6), atopic asthma status (atopic/non-atopic), chronic oral corticosteroid (OCS) use (presence vs absence) and geographical region as the covariates.|
1668791|NCT01402947|3071047|Non-Inferiority or Equivalence|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|0.999|||||2-Sided|90.0|0.893|1.117|||||||
1668792|NCT01402947|3071048|Non-Inferiority or Equivalence|If the 90% Confidence Intervals of the geometric mean ratio are wholly contained within the interval (0.80, 1.25), then the hypothesis of a drug interaction will be rejected.|Geometric Mean Ratio|1.013|||||2-Sided|90.0|0.933|1.1|||||||
1668793|NCT01402869|3071049|Non-Inferiority or Equivalence|Power of 80|||||=|0||||||P<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison|
1668794|NCT01402869|3071049|Non-Inferiority or Equivalence|Power of 80|||||<|0.001||||||P<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison|
1668795|NCT01402869|3071049|Non-Inferiority or Equivalence|Power of 80|||||<|0.001||||||P<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison|
1668796|NCT01402869|3071049|Non-Inferiority or Equivalence|Power of 80|||||<|0.001||||||P<.05|ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in delta methemoglobin blood levels following the administration prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.|
1668797|NCT01402869|3071050|Non-Inferiority or Equivalence|Power of 80|||||<|0.001||||||P<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison|
1668798|NCT01402869|3071050|Non-Inferiority or Equivalence|Power of 80|||||<|0.001||||||P<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison|
1668799|NCT01402869|3071050|Non-Inferiority or Equivalence|Power of 80|||||=|0||||||P<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison|
1668800|NCT01402869|3071050|Non-Inferiority or Equivalence|Power of 80|||||<|0.001|||||||ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in the time frame to peak methemoglobin levels following the administration of prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.|
1668803|NCT01402869|3071051|Non-Inferiority or Equivalence|Power of 80|||||<|0.001||||||P<.05|Least significant difference post hoc|||LSD post hoc pairwise comparison|
1668804|NCT01402869|3071051|Non-Inferiority or Equivalence|Power of 80|||||<|0.001||||||LSD post hoc test was used for multiple group comparisons. P<.05|ANOVA|LSD post hoc test was used for multiple group comparisons.||Null hypothesis: There is no statistically significant difference in peak methemoglobin blood levels following the administration of prilocaine, lidocaine, or no local anesthetic in pre-cooperative children undergoing comprehensive dental rehabilitation under general anesthesia.|
1668805|NCT01402570|3071055|Superiority or Other||REML|-1.05||||0.07|2-Sided|95.0|-2.21|0.1||Time was predictor of interest, controlling for age, gender, baseline fatigue, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.|
1668806|NCT01402570|3071056|Superiority or Other||REML|145.54||||0.35|2-Sided|95.0|-178.93|470.02||Time was predictor of interest, controlling for age, gender, baseline steps per day, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.|
1668807|NCT01402570|3071057|Superiority or Other||REML|0.0||||0.44|2-Sided|95.0|-0.01|0.02||Time was predictor of interest, controlling for age, gender, baseline sleep efficiency, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.|
1668808|NCT01402570|3071058|Superiority or Other||REML|0.17||||0.66|2-Sided|95.0|-0.67|0.95||Time was predictor of interest, controlling for age, gender, baseline PROMIS physical functioning, and overall functional status.|Mixed Models Analysis|||Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.|
1668809|NCT01402427|3071063|Superiority or Other|||||||0.45|||||||Fisher Exact||||
1668810|NCT01402427|3071064|Superiority or Other|||||||0.74|||||||Wilcoxon (Mann-Whitney)||||
1668811|NCT01402427|3071065|Superiority or Other|||||||0.28|||||||Wilcoxon (Mann-Whitney)||||
1668812|NCT01402427|3071066|Superiority or Other|||||||0.37|||||||Wilcoxon (Mann-Whitney)||||
1668813|NCT01402427|3071067|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1668814|NCT01402427|3071068|Superiority or Other|||||||0.11|||||||Fisher Exact||||
1668815|NCT01402427|3071069|Superiority or Other||Risk Difference (RD)|0.01||||0.28|2-Sided|95.0|-0.011|0.033|||Fisher Exact||||
1668816|NCT01401842|3071141|Superiority or Other|||||||0.021|||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on core muscular endurance (seconds) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.|
1668817|NCT01401842|3071142|Superiority or Other|||||||0.871|||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on core muscular endurance (seconds) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.|
1668818|NCT01401842|3071143|Superiority or Other|||||||0.001|||||||Mixed Models Analysis|||For the primary hypothesis, differences at follow-up between the two groups on lumbar extension muscular strength (Nm) were analyzed using linear mixed-effects regression models, accounting for the effects of cluster (platoon) and adjusting for baseline measures. The linear mixed-effects model treats the data as two levels (level 1 for individuals, level 2 for clusters), while also taking into account between-cluster variation.|
1668819|NCT01401543|3071160|Superiority or Other||Geometric LS Mean Ratio|0.98|||||2-Sided|90.0|0.91|1.04|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668820|NCT01401543|3071160|Superiority or Other||Geometric LS Mean Ratio|0.96|||||2-Sided|90.0|0.9|1.02|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668821|NCT01401543|3071160|Superiority or Other||Geometric LS Mean Ratio|0.69|||||2-Sided|90.0|0.65|0.74|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668822|NCT01401543|3071160|Superiority or Other||Geometric LS Mean Ratio|0.98|||||2-Sided|90.0|0.92|1.05|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668823|NCT01401543|3071160|Superiority or Other||Geometric LS Mean Ratio|0.71|||||2-Sided|90.0|0.66|0.76|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668824|NCT01401543|3071160|Superiority or Other||Geometric LS Mean Ratio|0.72|||||2-Sided|90.0|0.68|0.77|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668825|NCT01401543|3071161|Superiority or Other||Geometric LS Mean Ratio|1.01|||||2-Sided|90.0|0.95|1.08|||||||
1668826|NCT01401543|3071161|Superiority or Other||Geometric LS Mean Ratio|0.97|||||2-Sided|90.0|0.91|1.03|||||||
1668827|NCT01401543|3071161|Superiority or Other||Geometric LS Mean Ratio|0.96|||||2-Sided|90.0|0.9|1.02|||||||
1668828|NCT01401543|3071161|Superiority or Other||Geometric LS Mean Ratio|0.96|||||2-Sided|90.0|0.9|1.02|||||||
1668829|NCT01401543|3071161|Superiority or Other||Geometric LS Mean Ratio|0.94|||||2-Sided|90.0|0.89|1.0|||||||
1668831|NCT01401543|3071162|Non-Inferiority or Equivalence|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.99|||||2-Sided|90.0|0.91|1.08|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668832|NCT01401543|3071162|Non-Inferiority or Equivalence|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.91|||||2-Sided|90.0|0.84|1.0|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668833|NCT01401543|3071162|Non-Inferiority or Equivalence|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.77|||||2-Sided|90.0|0.7|0.84|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668834|NCT01401543|3071162|Non-Inferiority or Equivalence|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.93|||||2-Sided|90.0|0.85|1.01|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668835|NCT01401543|3071162|Non-Inferiority or Equivalence|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.78|||||2-Sided|90.0|0.71|0.85|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668836|NCT01401543|3071162|Non-Inferiority or Equivalence|Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.84|||||2-Sided|90.0|0.77|0.91|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668837|NCT01401543|3071163|Non-Inferiority or Equivalence|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|1.02|||||2-Sided|90.0|0.97|1.07|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668838|NCT01401543|3071163|Non-Inferiority or Equivalence|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.94|||||2-Sided|90.0|0.9|0.99|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668839|NCT01401543|3071163|Non-Inferiority or Equivalence|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.9|||||2-Sided|90.0|0.86|0.95|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668840|NCT01401543|3071163|Non-Inferiority or Equivalence|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.93|||||2-Sided|90.0|0.88|0.97|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668841|NCT01401543|3071163|Non-Inferiority or Equivalence|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric LS Mean Ratio|0.89|||||2-Sided|90.0|0.85|0.93|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668842|NCT01401543|3071163|Non-Inferiority or Equivalence|AUC(0-∞) was log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence, and period, and random factor for participant.|Geometric Least Squares (LS) Mean Ratio|0.96|||||2-Sided|90.0|0.91|1.01|||||Formulation, sequence, and period were included in the model as fixed effects, and participant as a random factor.||
1668843|NCT01401465|3071215|Non-Inferiority or Equivalence|The 95% CI of the LS mean difference of ciclesonide nasal aerosol minus mometasone aqueous nasal spray was calculated from the ANCOVA model, and the upper bound of the CI was compared to the non-inferiority margin of 0.5. Non-inferiority was declared if the upper bound of the 95% CI of this difference was < 0.5.|Difference in LS Means|-0.1|||||2-Sided|95.0|-0.3|0.1|||||Ciclesonide 74 mcg minus Mometasone 200 mcg|The null hypothesis is that the change from baseline in rTNSS for ciclesonide 74 mcg nasal aerosol minus the change from baseline in rTNSS for mometasone AQ 200 mcg is greater than 0.5.|
1668844|NCT01401465|3071216|Superiority or Other||Median Difference (Final Values)|88.889|||<|0.0001||||||If both primary endpoints are significant, the evaluation of this key secondary endpoint will be conducted at a significance level of 0.05.|Two-sided signed-rank test||Hodges-Lehman estimate of the CI not available due to ties.|The null hypothesis is that the median of the standardized Treatment Process Composite Preference Score = 50. Values > 50 indicate preference for ciclesonide, while values < 50 indicate preference for mometasone. Assuming an SD of 40, as observed in Study 060-301, a sample size of 128 will have 80% power to detect a difference of 0.25 SD units (10 raw score units) from the neutrality preference population value of 50, using a single group t-test with a 0.05 two-sided significant level|
1668845|NCT01401465|3071217|Superiority or Other||Odds Ratio (OR)|4.88|||<|0.0001|2-Sided|95.0|2.2|7.56||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Linear Mixed Model|Linear Mixed Model with effects for Period, Treatment, Sex, Race, Study Center, and covariates of Age and Baseline||The null hypothesis is that the mean change from baseline (CfBL) for CIC is equal to the mean CfBL for MOM. In Study 060-301, a correlation between BL periods 1 and 2 of 0.7 and a change score SD of 15 was seen for the RACS. A sample size of 41 in each sequence group (82 total ) gives a 2 x 2 crossover design 80% power to detect the difference in the CfBL of 0.35 SD units (5.25 raw score units) using a two group t-test with a 0.025 two-sided significance level and a SD of 15 for the difference.|
1668908|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 2; Total|ANCOVA||||
1668909|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 1; Total|ANCOVA||||
1668910|NCT01400932|3071291|Superiority or Other||||||<|0.001||||||Week 12; NIL|ANCOVA||||
1668846|NCT01401465|3071217|Superiority or Other||Odds Ratio (OR)|13.9|||<|0.0001|2-Sided|95.0|11.22|16.58||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Linear Mixed Model|Linear Mixed Model with effects for Period, Treatment, Sex, Race, Study Center, and covariates of Age and Baseline.||The null hypothesis is that the mean change from baseline (CfBL) for CIC is equal to the mean CfBL for MOM. In Study 060-301, a correlation between BL periods 1 and 2 of 0.7 and a change score SD of 15 was seen for the RACS. A sample size of 41 in each sequence group (82 total ) gives a 2 x 2 crossover design 80% power to detect the difference in the CfBL of 0.35 SD units (5.25 raw score units) using a two group t-test with a 0.025 two-sided significance level and a SD of 15 for the difference.|
1668847|NCT01401465|3071218|Superiority or Other||Slope|88.235|||<|0.0001||||||The significance level was set at 0.025 to adjust for the fact that two co-primary endpoints were being tested.|Two-sided Signed Rank Test||Hodges-Lehman estimate of the CI not available due to ties.|The null hypothesis is that the median of the standardized Total Preference Score = 50. Values > 50 indicate preference for ciclesonide, while values < 50 indicate preference for mometasone. For the primary endpoint of the Total Preference Score, assuming an SD of 40, a sample size of 155 will have 80% power to detect a difference of 0.25 SD units (10 raw score units) from the neutrality preference population value of 50, using a single group t-test with a 0.025 two-sided significance level.|
1668848|NCT01401166|3071247|Superiority or Other||Estimated Proportion|0.911|||||2-Sided|95.0|0.827|0.956|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.||
1668849|NCT01401166|3071247|Superiority or Other||Estimated Proportion|0.885|||||2-Sided|95.0|0.811|0.937|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.||
1668850|NCT01401166|3071247|Superiority or Other||Estimated Proportion|0.874|||||2-Sided|95.0|0.776|0.933|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.||
1668851|NCT01401166|3071247|Superiority or Other||Estimated Proportion|0.839|||||2-Sided|95.0|0.76|0.9|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.||
1668852|NCT01401166|3071247|Superiority or Other||Estimated Proportion|0.892|||||2-Sided|95.0|0.804|0.943|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.||
1668853|NCT01401166|3071247|Superiority or Other||Estimated Proportion|0.874|||||2-Sided|95.0|0.801|0.928|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial CI were determined.||
1668854|NCT01401166|3071247|Superiority or Other||Estimated Proportion|0.964|||||2-Sided|95.0|0.908|0.986|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding CI were determined using logistic regression with factors of previous Herceptin status and treatment.||
1668855|NCT01401166|3071247|Superiority or Other||Estimated Proportion|0.957|||||2-Sided|95.0|0.903|0.986|||||The estimated proportion of participants who preferred SC Herceptin and the corresponding exact binomial confidence interval (CI) were determined.||
1668856|NCT01401153|3071248|Non-Inferiority or Equivalence|No power calculation had been performed based on this measure||||||0.67|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)|||
1668857|NCT01401153|3071249|Non-Inferiority or Equivalence|No power calculation had been performed based on this measure||||||0.68|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)|||
1668858|NCT01401153|3071250|Non-Inferiority or Equivalence|No power calculation had been performed based on this measure||||||0.13|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)|||
1668859|NCT01401153|3071251|Non-Inferiority or Equivalence|No power calculation had been performed based on this measure||||||0.45|||||||t-test, 2 sided|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)|||
1668860|NCT01401153|3071252|Non-Inferiority or Equivalence|No power calculation had been performed based on this measure||||||0.11|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)|||
1668861|NCT01401153|3071253|Non-Inferiority or Equivalence|No power calculation had been performed based on this measure||||||0.62|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)|||
1668862|NCT01401153|3071254|Non-Inferiority or Equivalence|No power calculation had been performed based on this measure||||||0.63|||||||Generalized linear models||||
1668863|NCT01401153|3071255|Non-Inferiority or Equivalence|No power calculation had been performed based on this measure||||||0.33|||||||Generalized linear models||||
1668864|NCT01401153|3071256|Non-Inferiority or Equivalence|No power calculation had been performed based on this measure||||||0.7|||||||Generalized linear models||||
1668865|NCT01401153|3071257|Non-Inferiority or Equivalence|No power calculation had been performed based on this measure||||||0.25|||||||Generalized linear models|The fixed statement considered treatment, test day and the interaction between treatment and test day|||
1668866|NCT01401153|3071258|Non-Inferiority or Equivalence|No power calculation had been perfomed based on this measure||||||0.03|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)|||
1668867|NCT01401153|3071259|Non-Inferiority or Equivalence|No power calculation had been performed based on this measure||||||0.61|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)|||
1668868|NCT01401153|3071260|Non-Inferiority or Equivalence|No power calculation had been performed based on this measure||||||0.07|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)|||
1668911|NCT01400932|3071291|Superiority or Other||||||<|0.001||||||Week 8; NIL|ANCOVA||||
1668869|NCT01401153|3071261|Non-Inferiority or Equivalence|Power calculation based on parallel group design --> revealed that 68 children are needed to detect a difference of 45ms in the mean reaction time between the groups, with α=.05 and a power of 0.8.||||||0.79|||||||Wilcoxon (Mann-Whitney)|Individual differences of both test days compared on group level (having lunch/skipping lunch vs. skipping lunch/having lunch)||Power calculation had been performed.|
1668870|NCT01401101|3071262|Superiority or Other|||||||0.33||||||Jointly modeled outcomes at the 3 waves by time, condition, and timeXcondition, to allow for different effects at 6 and 12 mos; controlled for interview mode (phone vs. in-person); using random effects to control for correlations w/in site & patient.|Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions|
1668871|NCT01401101|3071263|Superiority or Other|||||||0.54|||||||Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions|
1668872|NCT01401101|3071264|Superiority or Other|||||||0.97||||||Jointly modeled outcomes at the 3 waves by time, condition, and timeXcondition, to allow for different effects at 6 and 12 mos; controlled for interview mode (phone vs. in-person); used random effects to account for correlations wi/in site & patient.|Regression, Linear|||Intent-to-treat (ITT) analysis using the linear mixed-method model to estimate the difference between the PCM and TAU conditions|
1668873|NCT01400971|3071282|Other|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. Diabetes Distress Scale ranges from 1-6 with higher scores indicating more distress.|Odds Ratio (OR)|0.74|||||2-Sided|95.0|0.57|0.95||||||Diabetes Distress Scale total score > 2|
1668874|NCT01400971|3071282|Other|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. IPC ranges from 1-5 with higher scores indicating more discrimination.|Odds Ratio (OR)|0.5|||||2-Sided|95.0|0.39|0.65||||||Discrimination domain of the IPC|
1668875|NCT01400971|3071282|Other|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|4.16|||||2-Sided|95.0|3.02|5.73||||||Baseline insulin therapy: pre-mixed only|
1668876|NCT01400971|3071282|Other|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|5.71|||||2-Sided|95.0|1.77|18.37||||||Baseline insulin therapy: prandial only|
1668877|NCT01400971|3071282|Other|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|10.5|||||2-Sided|95.0|3.3|33.41||||||Baseline insulin therapy: combination|
1668878|NCT01400971|3071282|Other|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|0.98|||||2-Sided|95.0|0.97|1.0||||||Age (per year increase)|
1668879|NCT01400971|3071282|Other|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.46|||||2-Sided|95.0|1.13|1.88||||||Diabetes duration > 11 years|
1668880|NCT01400971|3071282|Other|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.54|||||2-Sided|95.0|1.15|2.07||||||Baseline HbA1c missing (reference:HbA1c≤7.80 median)|
1668881|NCT01400971|3071282|Other|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.85|||||2-Sided|95.0|1.38|2.49||||||Baseline HbA1c > 7.80 (reference:HbA1c≤7.80 median)|
1668882|NCT01400971|3071282|Other|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|1.92|||||2-Sided|95.0|1.5|2.46||||||Diabetes support service available|
1668883|NCT01400971|3071282|Other|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy.|Odds Ratio (OR)|0.7|||||2-Sided|95.0|0.54|0.92||||||Public insurance|
1668884|NCT01400932|3071287|Superiority or Other||||||<|0.001||||||Week 12|ANCOVA||||
1668885|NCT01400932|3071287|Superiority or Other||||||<|0.001||||||Week 8|ANCOVA||||
1668886|NCT01400932|3071287|Superiority or Other||||||<|0.001||||||Week 4|ANCOVA||||
1668887|NCT01400932|3071287|Superiority or Other||||||<|0.001||||||Week 2|ANCOVA||||
1668888|NCT01400932|3071287|Superiority or Other||||||<|0.001||||||Week 1|ANCOVA||||
1668889|NCT01400932|3071288|Superiority or Other||||||<|0.001||||||Week 12|ANCOVA||||
1668890|NCT01400932|3071288|Superiority or Other||||||<|0.001||||||Week 8|ANCOVA||||
1668891|NCT01400932|3071288|Superiority or Other||||||<|0.001||||||Week 4|ANCOVA||||
1668892|NCT01400932|3071288|Superiority or Other||||||<|0.013||||||Week 2|ANCOVA||||
1668893|NCT01400932|3071288|Superiority or Other||||||<|0.174||||||Week 1|ANCOVA||||
1668894|NCT01400932|3071289|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1668895|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 12; NIL|ANCOVA||||
1668896|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 8; NIL|ANCOVA||||
1668897|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 4; NIL|ANCOVA||||
1668898|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 2; NIL|ANCOVA||||
1668899|NCT01400932|3071290|Superiority or Other||||||<|0.002||||||Week 1; NIL|ANCOVA||||
1668900|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 12; IL|ANCOVA||||
1668901|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 8; IL|ANCOVA||||
1668902|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 4; IL|ANCOVA||||
1668903|NCT01400932|3071290|Superiority or Other||||||<|0.001||||||Week 2; IL|ANCOVA||||
1668921|NCT01400932|3071292|Superiority or Other||||||<|0.001||||||Week 4|ANCOVA||||
1668922|NCT01400932|3071292|Superiority or Other||||||<|0.001||||||Week 2|ANCOVA||||
1668923|NCT01400932|3071292|Superiority or Other||||||<|0.001||||||Week 1|ANCOVA||||
1668924|NCT01400932|3071293|Superiority or Other||Mean Difference (Net)|-21.0|||<|0.001|2-Sided|95.0|-26.2|-15.8|||ANCOVA||||
1668925|NCT01400906|3071296|Superiority or Other||Mean Difference (Final Values)|0.53|||||2-Sided|95.0|0.38|0.68|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.||
1668926|NCT01400906|3071296|Superiority or Other||Mean Difference (Final Values)|0.476|||||2-Sided|95.0|0.326|0.627|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.||
1668927|NCT01400906|3071297|Superiority or Other||Mean Difference (Final Values)|0.165|||||2-Sided|95.0|0.008|0.323|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.||
1668928|NCT01400906|3071297|Superiority or Other||Mean Difference (Final Values)|0.175|||||2-Sided|95.0|0.018|0.333|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.||
1668929|NCT01400906|3071298|Superiority or Other||Mean Difference (Final Values)|0.661|||||2-Sided|95.0|0.463|0.859|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.||
1668930|NCT01400906|3071298|Superiority or Other||Mean Difference (Final Values)|0.638|||||2-Sided|95.0|0.44|0.836|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.||
1668931|NCT01400906|3071303|Superiority or Other||Mean Difference (Final Values)|0.161|||||2-Sided|95.0|-0.047|0.37|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.||
1668932|NCT01400906|3071303|Superiority or Other||Mean Difference (Final Values)|0.172|||||2-Sided|95.0|-0.037|0.38|||||The estimated value is an adjusted mean difference. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.||
1668933|NCT01400880|3071306|Superiority or Other||Mean Difference (Final Values)|3.95|Standard Deviation|2.65|||2-Sided|95.0|2.98|4.92||||||All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for the electrode sensor and IUPC. Agreement between electrode sensor and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.|
1668934|NCT01400880|3071306|Superiority or Other||Mean Difference (Final Values)|2.98|Standard Deviation|3.28|||2-Sided|95.0|1.7|4.27||||||All subjects were monitored with the electrode sensor, TOCO and IUPC. Measurements were taken with the electrode sensor vs. IUPC and were also taken with TOCO vs. IUPC and those measurements were compared to each other. These results are for TOCO and IUPC. Agreement between TOCO and IUPC. Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0.|
1668935|NCT01400516|3071345|Superiority||Median Difference (Final Values)|9.5||||0.28|2-Sided|||||A p-value < 0.05 is considered statistically significant.|Linear mixed model||control-teriparatide||
1668936|NCT01400477|3071353|Superiority|||||||0.89||||||A priori vape was <0.05|ANOVA|df 1, 37|||
1668937|NCT01400412|3071382|Superiority or Other||||||<|0.001||||||Two-sided p-value without adjustment for multiple testing, interpreted at the 5% nominal level of significance|Wilcoxon (Mann-Whitney)|Stratified Wilcoxon rank sum test stratified by age (<30 and >=30 years)||The null hypothesis is that there is no difference between the two arms in the percent of total hip BMD change from baseline to week 48|
1668938|NCT01400243|3071386|Superiority or Other||||||<|0.05|||||||ANOVA||||
1668939|NCT01400243|3071387|Superiority or Other|||||||0.05|||||||ANCOVA||||
1668940|NCT01399866|3071405|Superiority|||||||0.473|||||||t-test, 2 sided||||
1668941|NCT01399866|3071406|Superiority|||||||0.123|||||||ANOVA||||
1668942|NCT01399866|3071407|Superiority|||||||0.818|||||||ANOVA||||
1668943|NCT01399866|3071408|Superiority|||||||0.94|||||||ANOVA||||
1668944|NCT01399866|3071409|Superiority|||||||0.747|||||||ANOVA||||
1668945|NCT01399866|3071409|Superiority|||||||0.574|||||||ANOVA||||
1668946|NCT01399788|3071418|Superiority or Other||Ratio of Adjusted Means|101.8|||||2-Sided|90.0|99.24|104.43||||||Pyrazinamide; Natural log transformed AUC (0 -∞)(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1668947|NCT01399788|3071419|Superiority or Other||Ratio of Adjusted Means|100.97|||||2-Sided|90.0|96.28|105.88||||||Ethambutol; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1668948|NCT01399788|3071419|Superiority or Other||Ratio of Adjusted Means|105.74|||||2-Sided|90.0|100.32|111.46||||||Isoniazid; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1668949|NCT01399788|3071419|Superiority or Other||Ratio of Adjusted Means|104.3|||||2-Sided|90.0|99.7|109.1||||||Rifampicin; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1668968|NCT01399697|3071436|Superiority or Other|||||||0.328|||||||Chi-squared||||
1668969|NCT01399697|3071437|Superiority or Other|||||||0.7|||||||ANCOVA||||
1668950|NCT01399788|3071420|Superiority or Other||Ratio of Adjusted Means|95.17|||||2-Sided|90.0|88.6|102.22||||||Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 6.7% for Cmax was used for this power calculation. Natural log transformed Cmax(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1668951|NCT01399788|3071421|Superiority or Other||Ratio of Adjusted Means|101.73|||||2-Sided|90.0|99.12|104.4||||||Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 5.2% for AUClast was used for this power calculation. Natural log transformed AUClast(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1668952|NCT01399788|3071422|Superiority or Other||Ratio of Adjusted Means|99.48|||||2-Sided|90.0|94.92|104.25||||||Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 16.0% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1668953|NCT01399788|3071422|Superiority or Other||Ratio of Adjusted Means|103.85|||||2-Sided|90.0|92.13|117.07||||||Isoniazid; 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1668954|NCT01399788|3071422|Superiority or Other||Ratio of Adjusted Means|102.75|||||2-Sided|90.0|95.36|110.71||||||Rifampicin: 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1668955|NCT01399788|3071423|Superiority or Other||Ratio of Adjusted Means|99.48|||||2-Sided|90.0|94.92|104.25||||||Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.9% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1668956|NCT01399788|3071423|Superiority or Other||Ratio of Adjusted Means|107.28|||||2-Sided|90.0|101.95|112.9||||||Isoniazid; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.0% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1668957|NCT01399788|3071423|Superiority or Other||Ratio of Adjusted Means|103.81|||||2-Sided|90.0|99.2|108.64||||||Rifampicin; 32 participants (16 per sequence) provided at least 99% power that 90% confidence interval (CI) for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject coefficient of variation (CV) estimate of approximately 14.5% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1668958|NCT01399723|3071424|Non-Inferiority or Equivalence|The initial sample size estimate of 576 children (288 per group) would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|-3.3|||||2-Sided|95.0|-10.0|3.0|||||Risk difference comparison is for amoxicillin versus benzyl penicillin||
1668959|NCT01399723|3071427|Non-Inferiority or Equivalence|The initial sample size estimate of 576 children (288 per group) would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|0.4|||||2-Sided|95.0|-5.0|5.8|||||Risk difference comparison is for amoxicillin versus benzyl penicillin||
1668960|NCT01399723|3071428|Non-Inferiority or Equivalence|Noninferiority between amoxicillin and benzyl penicillin was defined a priori as a risk difference of treatment failure and associated upper bound of the 95% confidence interval (CI) of <7%. A sample size of 576 would provide 80% power to detect noninferiority of amoxicillin against benzyl penicillin within a margin of 7% at a 1-sided level of significance of 0.025, assuming a prevalence of treatment failure of 10% at 48 hours derived from a preintervention pilot phase of the study|Risk Difference (RD)|-0.4|||||2-Sided|95.0|-5.0|4.2|||||Risk difference comparison is for amoxicillin versus benzyl penicillin||
1668961|NCT01399697|3071429|Superiority or Other||Difference in LS Mean|-1.216||||0.655|2-Sided|95.0|-6.573|4.141|||ANCOVA||ANCOVA model with treatment as factor and VAS performed by the investigator at Week 16 as covariate.||
1668962|NCT01399697|3071430|Superiority or Other||Difference in LS Mean|0.969||||0.769|2-Sided|95.0|-5.526|7.464|||ANCOVA||ANCOVA model with treatment as factor and VAS performed by the participant at Week 16 as a covariate.||
1668963|NCT01399697|3071431|Superiority or Other||Difference in LS Mean|3.376||||0.015|2-Sided|95.0|0.676|6.076|||ANCOVA||ANCOVA model with treatment as factor and physical component score (PCS) as covariate.||
1668964|NCT01399697|3071432|Superiority or Other||Difference in LS Mean|-1.873||||0.204|2-Sided|95.0|-4.775|1.03|||ANCOVA||ANCOVA model with treatment as factor and mental component score (MCS) as covariate.||
1668965|NCT01399697|3071433|Superiority or Other||Difference in Least Square (LS) Mean|0.032||||0.674|2-Sided|95.0|-0.119|0.184|||ANCOVA||Analysis of covariance (ANCOVA) model with treatment as factor and DAS28 value at Week 16 as covariate.||
1668966|NCT01399697|3071434|Superiority or Other|||||||0.358|||||||Chi-squared||||
1668967|NCT01399697|3071435|Superiority or Other|||||||0.518|||||||Chi-squared||||
1668970|NCT01399619|3071448|Superiority or Other||||||<|0.0001||||||p-value corresponds to a two sided test against the historical rate of 40%.|normal approximation|||the SVR12 rate in total Faldaprevir group compared with the historical rate of 40%.|
1668971|NCT01399593|3071449|Superiority||Proportion difference|-3.9||||0.76|2-Sided|95.0|-23.9|16.3|||Fisher Exact||||
1668972|NCT01399229|3071457|Non-Inferiority or Equivalence|"Agreement between SureCALL® and Tocodynamometer Contraction Peak Times~Null hypothesis: The mean peak difference between RMS and TOCO is equal to 0. Alternative hypothesis: The mean peak difference is not equal to 0."|Mean Difference (Net)|0.99|Standard Error of the Mean|1.4086||0.4901|2-Sided|95.0|-28.74|30.72|||Mixed Models Analysis||||
1668973|NCT01399047|3071471|Superiority|||||||0.26|||||||Wilcoxon (Mann-Whitney)||||
1668974|NCT01399047|3071472|Superiority|||||||0.98|||||||Prescott's test||||
1668975|NCT01399047|3071473|Superiority|||||||0.78|||||||Prescott's test||||
1668976|NCT01399047|3071474|Superiority or Other||Mean Difference (Net)|-0.69||||0.72|2-Sided|95.0|-4.67|3.28|||Prescott's test||||
1668977|NCT01399047|3071475|Superiority or Other||Risk Difference (RD)|0.105||||0.21|2-Sided|95.0|-0.033|0.243|||Prescott's test||Mycophenolate was tolerated in 17/19 subjects (89.5%, 95% CI: 66.9% - 98.7%), while placebo was tolerated in 19/19 subjects (100%, 95% CI: 82.4% - 100%). The difference in tolerability rates was 10.5% (95% CI: -3.3% - 24.3%, p=0.21).|The primary outcome variable was tolerability, defined as the proportion of subjects able to complete 8 weeks on the assigned treatment. Tolerability was compared among the treatment groups using Prescott's test. A 95% confidence interval was computed for the tolerability of mycophenolate, placebo, and their difference.|
1668978|NCT01398982|3071490|Non-Inferiority or Equivalence|Based on our published prospective, nonrandomized study using TAP block in abdominally-based autologous tissue breast reconstruction, 40 patients per group would achieve 85% power to detect a 65% reduction in mean total opioid consumption between the control and study groups (significance level alpha = 0.05; using a two-sided Wilcoxon rank-sum test).||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1668979|NCT01398943|3071494|Superiority or Other||||||>|0.05|||||||ANOVA||||
1668980|NCT01398943|3071494|Superiority or Other||||||<|0.05|||||||ANOVA||||
1668981|NCT01398943|3071495|Superiority or Other||||||>|0.05|||||||ANOVA||||
1668982|NCT01398943|3071495|Superiority or Other||||||<|0.05|||||||ANOVA||||
1668983|NCT01398475|3071506|Superiority or Other||Median Difference (Final Values)|0.5||||0.006|2-Sided|90.0|0.0|2.0|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF2 fed minus TF2 fasted.||
1668984|NCT01398475|3071506|Superiority or Other||Median Difference (Final Values)|0.0||||0.96|2-Sided|90.0|-0.25|0.75|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF2 fasted minus RF fasted.||
1668985|NCT01398475|3071506|Superiority or Other||Median Difference (Final Values)|0.0||||0.719|2-Sided|90.0|-0.25|0.5|||Wilcoxon (Mann-Whitney)||The median difference was calculated as TF1 fasted minus RF fasted.||
1668986|NCT01398475|3071507|Superiority or Other||Geometric LS mean ratio|0.82|||||2-Sided|90.0|0.727|0.925|||||The geometric LS mean ratio (TF2 fed divided by TF2 fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.||
1668987|NCT01398475|3071507|Superiority or Other||Geometric LS mean ratio|0.962|||||2-Sided|90.0|0.852|1.08|||||The geometric LS mean ratio (TF2 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.||
1668988|NCT01398475|3071507|Superiority or Other||Geometric least squares (LS) mean ratio|0.979|||||2-Sided|90.0|0.868|1.1|||||The geometric LS mean ratio (TF1 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.||
1668989|NCT01398475|3071508|Superiority or Other||Geometric LS mean ratio|0.888|||||2-Sided|90.0|0.827|0.953|||||The geometric LS mean ratio (TF2 fed divided by TF2 fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.||
1668990|NCT01398475|3071508|Superiority or Other||Geometric LS mean ratio|1.02|||||2-Sided|90.0|0.947|1.09|||||The geometric LS mean ratio (TF2 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.||
1668991|NCT01398475|3071508|Superiority or Other||Geometric least squares (LS) mean ratio|1.02|||||2-Sided|90.0|0.951|1.1|||||The geometric LS mean ratio (TF1 fasted divided by RF fasted) was calculated using a linear mixed-effects model adjusted for treatment, sequence, period, and participant.||
1668992|NCT01397890|3071520|Superiority or Other|||||||0.0196|||||||Log Rank||||
1668993|NCT01397890|3071520|Superiority or Other||Cox Proportional Hazard|0.614||||0.0167|2-Sided|95.0|0.412|0.916|||Regression, Cox|Time to the first COPD exacerbation|||
1668994|NCT01397890|3071520|Superiority or Other||Rate ratio|0.593||||0.0032|2-Sided|95.0|0.419|0.839|||Poisson regression|Poisson regression model with treatment as a factor and the duration time in study as an offset variable morning PEF as a covariate|||
1668995|NCT01397890|3071521|Superiority or Other||Mean Difference (Net)|-0.122||||0.0171|2-Sided|95.0|-0.222|-0.022|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1668996|NCT01397890|3071522|Superiority or Other||Mean Difference (Net)|-0.143||||0.0067|2-Sided|95.0|-0.246|-0.04|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1668997|NCT01397890|3071523|Superiority or Other||Mean Difference (Net)|-0.262|||<|0.0001|2-Sided|95.0|-0.364|-0.159|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1668998|NCT01397890|3071524|Superiority or Other||Mean Difference (Net)|-0.231||||0.0001|2-Sided|95.0|-0.35|-0.113|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1668999|NCT01397890|3071525|Superiority or Other||Mean Difference (Net)|-0.124||||0.0372|2-Sided|95.0|-0.24|-0.007|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1669000|NCT01397890|3071526|Superiority or Other||Mean Difference (Net)|-0.236||||0.0028|2-Sided|95.0|-0.391|-0.082|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1669034|NCT01397422|3071607|Superiority||Least Squares Mean Difference|0.3||||0.5223|2-Sided|95.0|-0.5|1.0|||ANCOVA||||
1669001|NCT01397890|3071527|Superiority or Other||Mean Difference (Net)|-0.551|||<|0.0001|2-Sided|95.0|-0.741|-0.361|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1669002|NCT01397890|3071528|Superiority or Other||Mean Difference (Net)|-0.375|||<|0.0001|2-Sided|95.0|-0.552|-0.198|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1669003|NCT01397890|3071529|Superiority or Other||Mean Difference (Net)|-0.668|||<|0.0001|2-Sided|95.0|-0.9|-0.437|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1669004|NCT01397890|3071530|Superiority or Other||Mean Difference (Net)|18.472|||<|0.0001|2-Sided|95.0|10.347|26.596|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1669005|NCT01397890|3071531|Superiority or Other||Mean Difference (Net)|17.192||||0.0006|2-Sided|95.0|7.491|26.894|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1669006|NCT01397890|3071532|Superiority or Other||Mean Difference (Net)|26.428||||0.0001|2-Sided|95.0|13.463|39.393|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1669007|NCT01397890|3071533|Superiority or Other||Mean Difference (Net)|17.469|||<|0.0001|2-Sided|95.0|10.147|24.791|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1669008|NCT01397890|3071534|Superiority or Other||Mean Difference (Net)|13.587|||<|0.0001|2-Sided|95.0|7.407|19.766|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1669009|NCT01397890|3071535|Superiority or Other||Mean Difference (Net)|20.303||||0.0001|2-Sided|95.0|9.904|30.702|||ANCOVA|Additive ANCOVA model with treatment and centre as fixed factors and the run-in mean of pre-dose morning PEF as a covariate|||
1669010|NCT01397890|3071536|Superiority or Other||Ratio|1.062|||<|0.0001|2-Sided|95.0|1.035|1.091|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.|||
1669011|NCT01397890|3071537|Superiority or Other||Ratio|1.02||||0.1956|2-Sided|95.0|0.99|1.05|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.|||
1669012|NCT01397890|3071538|Superiority or Other||Ratio|1.054|||<|0.0001|2-Sided|95.0|1.036|1.073|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.|||
1669013|NCT01397890|3071539|Superiority or Other||Ratio|1.05|||<|0.0001|2-Sided|95.0|1.033|1.067|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.|||
1669014|NCT01397890|3071540|Superiority or Other||Ratio|1.018||||0.057|2-Sided|95.0|0.999|1.037|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.|||
1669015|NCT01397890|3071541|Superiority or Other||Ratio|1.086|||<|0.0001|2-Sided|95.0|1.062|1.111|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.|||
1669016|NCT01397890|3071542|Superiority or Other||Ratio|1.079|||<|0.0001|2-Sided|95.0|1.057|1.102|||ANCOVA|Multiplicative ANCOVA model with treatment and country as fixed factors and week 0 pre-dose value as a (log-transformed) covariate.|||
1669017|NCT01397890|3071543|Superiority or Other||Ratio|1.044||||0.0004|2-Sided|95.0|1.019|1.069|||ANCOVA|multiplicative ANCOVA model with treatment and country as fixed factors and baseline value as a (log-transformed) covariate|||
1669018|NCT01397461|3071600|Superiority or Other|||||||0.003|||||||Chi-squared|||"The treatment comparison was done using only the outcomes of Clinical success and Clinical failure. The p value of the chi square test (without continuity correction) and corresponding 95% asymptotic (Wald) CI for the difference in success rates for the ozenoxacin versus placebo were provided. The analysis was performed to test the superiority of ozenoxacin versus placebo.~Text extracted from the statistical analysis plan. No additional data was pre-specified for the statistical comparison"|
1669019|NCT01397448|3071601|Superiority or Other||Hazard Ratio (HR)|0.05|||<|0.001|2-Sided|95.0|0.01|0.23|||Log Rank||||
1669020|NCT01397448|3071601|Superiority or Other||Hazard Ratio (HR)|0.11|||<|0.001|2-Sided|95.0|0.04|0.31|||Log Rank||||
1669021|NCT01397422|3071603|Superiority|||||||0.1042|||||||Cochran-Mantel-Haenszel|Equally spaced scores|||
1669022|NCT01397422|3071603|Superiority|||||||0.2158|||||||Cochran-Mantel-Haenszel||||
1669023|NCT01397422|3071603|Superiority|||||||0.0036|||||||Cochran-Mantel-Haenszel||||
1669024|NCT01397422|3071604|Superiority||Least Squares Mean Difference|1.2||||0.7862|2-Sided|95.0|-7.7|10.1|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate|||
1669025|NCT01397422|3071604|Superiority||Least Squares Mean Difference|1.7||||0.7053|2-Sided|95.0|-7.2|10.6|||ANCOVA||||
1669026|NCT01397422|3071604|Superiority||Least Squares Mean Difference|-2.2||||0.6355|2-Sided|95.0|-11.2|6.9|||ANCOVA||||
1669027|NCT01397422|3071605|Superiority||Least Squares Mean Difference|3.3||||0.004|2-Sided|95.0|1.1|5.5|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate|||
1669028|NCT01397422|3071605|Superiority||Least Squares Mean Difference|2.7||||0.0179|2-Sided|95.0|0.5|5.0|||ANCOVA||||
1669029|NCT01397422|3071605|Superiority||Least Squares Mean Difference|3.0||||0.0078|2-Sided|95.0|0.8|5.2|||ANCOVA||||
1669030|NCT01397422|3071606|Superiority||Least Squares Mean Difference|-2.5||||0.1469|2-Sided|95.0|-6.0|0.9|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.|||
1669031|NCT01397422|3071606|Superiority||Least Squares Mean Difference|-6.4||||0.0004|2-Sided|95.0|-9.8|-2.9|||ANCOVA||||
1669032|NCT01397422|3071606|Superiority||Least Squares Mean Difference|-5.2||||0.0038|2-Sided|95.0|-8.7|-1.7|||ANCOVA||||
1669033|NCT01397422|3071607|Superiority||Least Squares Mean Difference|0.2||||0.6298|2-Sided|95.0|-0.6|1.0|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, baseline value is a covariate|||
1669035|NCT01397422|3071607|Superiority||Least Squares Mean Difference|-0.3||||0.4314|2-Sided|95.0|-1.1|0.5|||ANCOVA||||
1669036|NCT01397422|3071608|Superiority||Least Squares Mean Difference|-5.6||||0.1595|2-Sided|95.0|-13.4|2.2|||ANCOVA||||
1669037|NCT01397422|3071608|Superiority||Least Squares Mean Difference|-10.0||||0.0131|2-Sided|95.0|-17.8|-2.2|||ANCOVA||||
1669038|NCT01397422|3071608|Superiority||Least Squares Mean Difference|-11.3||||0.0051|2-Sided|95.0|-19.1|-3.5|||ANCOVA|Change from baseline is a dependent variable, treatment group is a factor, and the baseline value is a covariate.||20 subjects per treatment arm provided 80% power using a 2-sided 2-sample test at 5% significance. The null hypothesis for the primary endpoint was that the response of the ADS-5102 340 mg group was equal to that of the placebo group.|
1669039|NCT01397084|3071623|Superiority or Other||||||<|0.001|||||||Wilocoxon signed-rank test|||Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.|
1669040|NCT01397071|3071624|Other||% of baseline|0.58||||0.03|2-Sided|||||Significance is defined as p<0.05.|t-test, 2 sided|||Comparison was made to beef patty alone vs. beef patty with avocado added 3 hours post-ingestion.|
1669041|NCT01397071|3071625|Other||Mean Difference (Final Values)|2.2||||0.052|2-Sided|95.0|||||t-test, 2 sided|||Comparison of change in PAT measurements was made to beef alone vs. beef with avocado 2 hours post-ingestion|
1669042|NCT01396447|3071724|Superiority||Mean Difference (Final Values)|-0.3||||0.0489|2-Sided|95.0|-0.5|0.0|||Repeated measures mixed-effects model||Cariprazine 3.0 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|
1669043|NCT01396447|3071724|Superiority||Mean Difference (Final Values)|-0.4||||0.0044|2-Sided|95.0|-0.6|-0.2|||Repeated measures mixed-effects model||Cariprazine 1.5 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|
1669044|NCT01396447|3071724|Superiority||Mean Difference (Final Values)|-0.1||||0.3025|2-Sided|95.0|-0.4|0.1|||Repeated measures mixed-effects model||Cariprazine 0.75 mg vs Placebo|The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|
1669045|NCT01396447|3071725|Superiority||Mean Difference (Final Values)|-2.5||||0.0374|2-Sided|95.0|-4.9|-0.1||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 3.0 mg vs Placebo||
1669046|NCT01396447|3071725|Superiority||Mean Difference (Final Values)|-4.0||||0.001|2-Sided|95.0|-6.3|-1.6||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 1.5 mg vs Placebo||
1669047|NCT01396447|3071725|Superiority||Mean Difference (Final Values)|-1.9||||0.1292|2-Sided|95.0|-4.3|0.5||The analysis included treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.|Repeated measures mixed-effects model||Cariprazine 0.75 mg vs Placebo||
1669048|NCT01396421|3071727|Superiority or Other||Treatment difference|-0.21||||0.6251|2-Sided|95.0|-1.07|0.64||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669049|NCT01396421|3071727|Superiority or Other||Treatment difference|-0.65||||0.0655|2-Sided|95.0|-1.34|0.04||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669050|NCT01396421|3071727|Superiority or Other||Treatment difference|-0.34||||0.3284|2-Sided|95.0|-1.03|0.35||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669051|NCT01396421|3071728|Superiority or Other||Treatment difference|-0.33||||0.5172|2-Sided|95.0|-1.31|0.66||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669052|NCT01396421|3071728|Superiority or Other||Treatment difference|-1.08||||0.0081|2-Sided|95.0|-1.88|-0.28||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669053|NCT01396421|3071728|Superiority or Other||Treatment difference|-1.07||||0.0085|2-Sided|95.0|-1.87|-0.28||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669054|NCT01396421|3071729|Superiority or Other||Treatment difference|-0.72||||0.2572|2-Sided|95.0|-1.96|0.52||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669055|NCT01396421|3071729|Superiority or Other||Treatment difference|-1.98||||0.0001|2-Sided|95.0|-2.98|-0.97||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669056|NCT01396421|3071729|Superiority or Other||Treatment difference|-1.75||||0.0007|2-Sided|95.0|-2.76|-0.75||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669057|NCT01396421|3071730|Superiority or Other||Treatment difference|-0.86||||0.1956|2-Sided|95.0|-2.17|0.44||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669058|NCT01396421|3071730|Superiority or Other||Treatment difference|-1.68||||0.0019|2-Sided|95.0|-2.73|-0.62||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669059|NCT01396421|3071730|Superiority or Other||Treatment difference|-1.3||||0.0155|2-Sided|95.0|-2.35|-0.25||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669060|NCT01396421|3071731|Superiority or Other||Treatment difference|-0.89||||0.3263|2-Sided|95.0|-2.66|0.89||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis||||
1669061|NCT01396421|3071731|Superiority or Other||Treatment difference|-2.47||||0.0008|2-Sided|95.0|-3.91|-1.04||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669062|NCT01396421|3071731|Superiority or Other||Treatment difference|-2.34||||0.0014|2-Sided|95.0|-3.77|-0.91||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669063|NCT01396421|3071732|Superiority or Other||Relative risk|0.77||||0.5115|2-Sided|95.0|0.35|1.68||CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.|Cochran-Mantel-Haenszel||||
1669064|NCT01396421|3071732|Superiority or Other||Relative risk|0.87||||0.6606|2-Sided|95.0|0.46|1.65||CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.|Cochran-Mantel-Haenszel||||
1669065|NCT01396421|3071732|Superiority or Other||Relative risk|0.39||||0.0143|2-Sided|95.0|0.18|0.85|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial center was applied to the analysis of discontinuation rate.|||
1669066|NCT01396421|3071733|Superiority or Other||Treatment difference|-0.34||||0.5706|2-Sided|95.0|-1.53|0.85||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669067|NCT01396421|3071733|Superiority or Other||Treatment difference|-1.22||||0.0131|2-Sided|95.0|-2.19|-0.26||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669068|NCT01396421|3071733|Superiority or Other||Treatment difference|-1.1||||0.0246|2-Sided|95.0|-2.06|-0.14||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669069|NCT01396421|3071734|Superiority or Other||Relative risk|1.27||||0.1576|2-Sided|95.0|0.92|1.76||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel||||
1669070|NCT01396421|3071734|Superiority or Other||Relative risk|1.59||||0.0004|2-Sided|95.0|1.23|2.05||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel||||
1669071|NCT01396421|3071734|Superiority or Other||Relative risk|1.48||||0.0032|2-Sided|95.0|1.14|1.91||CMH general association test controlling for trial was applied to the analysis of response rate.|Cochran-Mantel-Haenszel||||
1669072|NCT01396421|3071735|Superiority or Other||Treatment difference|-0.14||||0.4505|2-Sided|95.0|-0.5|0.22||The CMH row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel||||
1669073|NCT01396421|3071735|Superiority or Other||Treatment difference|-0.54||||0.0002|2-Sided|95.0|-0.82|-0.26||The CMH row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel||||
1669074|NCT01396421|3071735|Superiority or Other||Treatment difference|-0.5||||0.0004|2-Sided|95.0|-0.77|-0.22||The Cochran-Mantel-Haenzel (CMH) row mean scores differ test controlling for trial center was applied to CGI-I score.|Cochran-Mantel-Haenszel||||
1669075|NCT01396421|3071736|Superiority or Other||Treatmetn difference|-1.07||||0.0996|2-Sided|95.0|-2.33|0.2||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669076|NCT01396421|3071736|Superiority or Other||Least squares mean|-1.78||||0.0007|2-Sided|95.0|-2.81|-0.76||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669077|NCT01396421|3071736|Superiority or Other||Treatment difference|-1.41||||0.0069|2-Sided|95.0|-2.44|0.39||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669078|NCT01396421|3071737|Superiority or Other||Treatment difference|-1.11||||0.2227|2-Sided|95.0|-2.9|0.68||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669079|NCT01396421|3071737|Superiority or Other||Treatment difference|-2.22||||0.0029|2-Sided|95.0|-3.67|-0.77||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669080|NCT01396421|3071737|Superiority or Other||Treatment difference|-2.44||||0.001|2-Sided|95.0|-3.88|-0.99||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669081|NCT01396421|3071738|Superiority or Other||Treatment difference|1.58||||0.3264|2-Sided|95.0|-1.58|4.74||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6|||
1669082|NCT01396421|3071738|Superiority or Other||Treatment difference|2.89||||0.025|2-Sided|95.0|0.37|5.42||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6|||
1669083|NCT01396421|3071738|Superiority or Other||Treatment difference|2.46||||0.0557|2-Sided|95.0|-0.06|4.98||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 6|||
1669084|NCT01396421|3071739|Superiority or Other||Treatment difference|-0.04||||0.7619|2-Sided|95.0|-0.32|0.23||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5|||
1669085|NCT01396421|3071739|Superiority or Other||Least squares mean|-0.34||||0.0032|2-Sided|95.0|-0.56|-0.11||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5|||
1669086|NCT01396421|3071739|Superiority or Other||Treatment difference|-0.39||||0.0006|2-Sided|95.0|-0.61|-0.17||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5|||
1669087|NCT01396421|3071739|Superiority or Other||Treatment difference|-0.04||||0.7587|2-Sided|95.0|-0.3|0.22||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4|||
1669088|NCT01396421|3071739|Superiority or Other||Least squares mean|-0.19||||0.0662|2-Sided|95.0|-0.4|0.01||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4|||
1669089|NCT01396421|3071739|Superiority or Other||Treatment difference|-0.42|||<|0.0001|2-Sided|95.0|-0.63|-0.21||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4|||
1669090|NCT01396421|3071739|Superiority or Other||Treatment difference|0.18|||<|0.1173|2-Sided|95.0|-0.04|0.4||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3|||
1669091|NCT01396421|3071739|Superiority or Other||Least squares mean|-0.09|||<|0.3275|2-Sided|95.0|-0.27|0.09||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3|||
1669092|NCT01396421|3071739|Superiority or Other||Treatment difference|-0.21|||<|0.0219|2-Sided|95.0|-0.39|-0.03||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3|||
1669093|NCT01396421|3071739|Superiority or Other||Treatment difference|0.12|||<|0.1678|2-Sided|95.0|-0.05|0.3||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2|||
1669094|NCT01396421|3071739|Superiority or Other||Leasr squares mean|-0.12|||<|0.0825|2-Sided|95.0|-0.27|0.02||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis||||
1669095|NCT01396421|3071739|Superiority or Other||Treatment difference|-0.15|||<|0.0347|2-Sided|95.0|-0.29|-0.01||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2|||
1669096|NCT01396421|3071739|Superiority or Other||Treatment difference|0.03|||<|0.6446|2-Sided|95.0|-0.1|0.15||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates..|Mixed Models Analysis|Week 1|||
1669097|NCT01396421|3071739|Superiority or Other||Treatment difference|-0.03|||<|0.617|2-Sided|95.0|-0.13|0.08||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1|||
1669098|NCT01396421|3071739|Superiority or Other||Treatment difference|-0.02|||<|0.6553|2-Sided|95.0|-0.13|0.08||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1|||
1669099|NCT01396421|3071740|Superiority or Other||Treatment difference|-1.12||||0.657|2-Sided|95.0|-6.07|3.83||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5|Because only the comparison of brexpiprazole 4 mg/day versus placebo met the threshold in the primary analysis, the following analysis is not part for the formal statistical testing and is descriptive only.||
1669100|NCT01396421|3071740|Superiority or Other||Treatment difference|-7.15||||0.0005|2-Sided|95.0|-11.2|-3.14||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 5|||
1669101|NCT01396421|3071740|Superiority or Other||Treatment difference|-7.86||||0.0001|2-Sided|95.0|-11.9|-3.86||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 5|||
1669102|NCT01396421|3071740|Superiority or Other||Treatment difference|1.93||||0.3407|2-Sided|95.0|-2.05|5.9||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3|||
1669103|NCT01396421|3071740|Superiority or Other||Treatment difference|-5.16||||0.0062|2-Sided|95.0|-8.85|-1.47||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 4|||
1669104|NCT01396421|3071740|Superiority or Other||Treatment difference|-7.61|||<|0.0001|2-Sided|95.0|-11.3|-3.93||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4|||
1669105|NCT01396421|3071740|Superiority or Other||Treatment difference|0.04|||<|0.9876|2-Sided|95.0|-4.53|4.6||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 4|||
1669106|NCT01396421|3071740|Superiority or Other||Treatment difference|-3.45|||<|0.036|2-Sided|95.0|-6.67|-0.23||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3|||
1669107|NCT01396421|3071740|Superiority or Other||Treatment difference|-4.4|||<|0.0009|2-Sided|95.0|-6.97|-1.82||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2|||
1669131|NCT01396044|3071875|Superiority or Other|||||||0.093|||||||t-test, 2 sided||||
1669108|NCT01396421|3071740|Superiority or Other||Treatment difference|1.84|||<|0.2568|2-Sided|95.0|-1.34|5.02||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 2|||
1669109|NCT01396421|3071740|Superiority or Other||Treatment difference|-3.75|||<|0.0045|2-Sided|95.0|-6.33|-1.17||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates|Mixed Models Analysis|Week 2|||
1669110|NCT01396421|3071740|Superiority or Other||Treatment difference|-5.14|||<|0.0018|2-Sided|95.0|-8.36|-1.93||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 3|||
1669111|NCT01396421|3071740|Superiority or Other||Treatment difference|0.35|||<|0.7231|2-Sided|95.0|-1.61|2.32||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1|||
1669112|NCT01396421|3071740|Superiority or Other||Treatment difference|-1.99|||<|0.0139|2-Sided|95.0|-3.58|-0.41||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|Mixed Models Analysis|Week 1|||
1669113|NCT01396421|3071740|Superiority or Other||Treatment difference|-1.5|||<|0.0644|2-Sided|95.0|-3.09|0.09||MMRM with fixed effect of treatment, (pooled) clinical center, visit, treatment visit interaction, baseline value, and baseline visit interaction as covariates.|Mixed Models Analysis|Week 1|||
1669114|NCT01396421|3071741|Superiority or Other||Treatment difference|-0.03||||0.8491|2-Sided|95.0|-0.31|0.26|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|||
1669115|NCT01396421|3071741|Superiority or Other||Treatment difference|-0.33||||0.0056|2-Sided|95.0|-0.56|-0.1|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|||
1669116|NCT01396421|3071741|Superiority or Other||Treatment difference|-0.38||||0.0012|2-Sided|95.0|-0.61|-0.15|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.|||
1669117|NCT01396421|3071741|Superiority or Other||Treatment difference|-0.36||||0.0006|2-Sided|95.0|-0.56|-0.15|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Difference between the average effect of brexpiprazole 2 and 4 mg/day and placebo was tested first at alpha level of 0.05. If statistically significant, then comparisons for each group (brexpiprazole 2 and 4 mg/day) versus placebo were performed at a significance level of 0.05.|
1669118|NCT01396421|3071742|Superiority or Other||Treatment difference|-2.89||||0.291|2-Sided|95.0|-8.27|2.49|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of −7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test|
1669119|NCT01396421|3071742|Superiority or Other||Traetment difference|-8.72|||<|0.0001|2-Sided|95.0|-13.1|-4.37|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of −7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test|
1669120|NCT01396421|3071742|Superiority or Other||Treatment difference|-7.64|||<|0.0006|2-Sided|95.0|-12.0|-3.3|||Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Sample size was determined to achieve 90% power at alpha level of 0.025 (two-sided) to a detect treatment difference of −7.5 points in change from baseline in PANSS Total Score at Week 6 (last observation carried forward) between a brexpiprazole treatment of 4 mg/day (or 2 mg/day) and placebo using a two-sided z-test|
1669121|NCT01396421|3071742|Superiority or Other||Treatment difference|-8.18|||<|0.0001|2-Sided|95.0|-12.0|-4.4||Primary analysis was performed by fitting a Mixed Model Repeated Measures (MMRM) which included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.|Mixed Models Analysis|MMRM with fixed effect of treatment, clinical center, visit, treatment visit interaction, baseline value, baseline visit interaction as covariates.||Difference between average effect of brexpiprazole 2 and 4 mg/day and placebo was tested first at alpha level of 0.05. If statistically significant, then comparisons for each group (brexpiprazole 2 and 4 mg/day) versus placebo were performed.|
1669122|NCT01396395|3071758|Superiority or Other||Ratio|0.503|||=|0|2-Sided|95.0|0.301|0.84|||Poisson regression: Calibration model||||
1669123|NCT01396395|3071758|Superiority or Other||Ratio|0.503|||<|0.0001|2-Sided|95.0|0.435|0.581|||poisson regression: Non-calibration mode||||
1669124|NCT01396265|3071774|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|78.41|Standard Deviation|15.6|||2-Sided|90.0|72.363|84.968|||||The standard deviation is actually the geometric coefficient of variation||
1669125|NCT01396265|3071775|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|66.18|Standard Deviation|16.5|||2-Sided|90.0|60.656|72.213|||||The standard deviation is actually the geometric coefficient of variation||
1669126|NCT01396265|3071776|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|66.2|Standard Deviation|16.1|||2-Sided|90.0|60.815|72.057|||||The standard deviation is actually the geometric coefficient of variation||
1669127|NCT01396044|3071870|Superiority or Other|||||||0.002|||||||Chi-squared||||
1669128|NCT01396044|3071872|Superiority or Other|||||||0.36|||||||Wilcoxon (Mann-Whitney)||||
1669129|NCT01396044|3071873|Superiority or Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1669130|NCT01396044|3071874|Superiority or Other|||||||0.17|||||||Chi-squared||||
1669132|NCT01396044|3071876|Superiority or Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1669133|NCT01395901|3071892|Non-Inferiority or Equivalence|For the primary efficacy analysis, the confidence interval (CI) was built on the FAS using the stratum adjusted Mantel-Haenszel (MH) method with correction of continuity. The non-inferiority margin was -10%.|Risk Difference (RD)|-4.4|||||2-Sided|95.0|-10.5|1.7||||||"The null hypothesis (H0) was stated as:~• H0 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron <-10%~The alternative hypothesis (H1) was stated as:~• H1 : CR 0-24 hr palonosetron - CR 0-24 hr ondansetron >-10%~A power of 80% was used for sample size computation."|
1669134|NCT01395888|3071893|Superiority or Other||Least Squares Mean Difference|0.259||||0.484|2-Sided|95.0|-0.468|0.986|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|||
1669135|NCT01395823|3071894|Superiority or Other|||||||0.78|||||||Mixed Models Analysis||||
1669136|NCT01395758|3071907|Superiority|||||||0.4356|||||||Log Rank||||
1669137|NCT01395758|3071908|Superiority|||||||0.5017|||||||Log Rank||||
1669138|NCT01395030|3071934|Other||||||||||||||||||"Analysis was performed using Gene Set Enrichment Analysis (GSEA version 19.0.24, Broad Institute, Cambridge, MA) implemented in GenePattern (Broad Institute, Cambridge, MA) by uploading expression array data to this cloud-computing genomics platform. The specific details of this statistical approach can be found in the following publicly available references:~Reich M, Liefeld T, Gould J, Lerner J, Tamayo P, Mesirov JP. GenePattern 2.0 Nature Genetics 38 no. 5 (2006): pp500-501~Subramanian A, Tamayo P, Mootha VK, Mukherjee S, Ebert BL, Gillette MA, Paulovich A, Pomeroy SL, Golub TR, Lander ES, Mesirov JP. Gene set enrichment analysis: A knowledge-based approach for interpreting genome-wide expression profiles. PNAS. 2005;102(43);15545-15550."
1669139|NCT01395017|3071937|Superiority or Other||Hazard Ratio (HR)|0.99||||0.6761|2-Sided|95.0|0.73|1.34||The log-rank test was used to test PFS. As a sensitivity analysis, HR and its confidence interval was also provided for PFS using the Cox proportional hazard model.|Cox proportional hazard model|Adjusting for baseline factors: treatment, ECOG PS, region, CA19-9 level (< 1000 IU/mL or >/=1000 IU/mL), and RT during trial (yes or no).||Trial has 88% power to show a median PFS increase from 5 to 7 months (with 1-sided alpha=0.15, total 176 events, HR=0.714).|
1669140|NCT01395017|3071938|Superiority or Other||Hazard Ratio (HR)|1.19||||0.3864|2-Sided|95.0|0.85|1.65||The log-rank test was used to test OS. As a sensitivity analysis, HR and its confidence interval was also provided for OS using the Cox proportional hazard model.|Cox proportional hazard model|Adjusting for baseline factors - treatment, ECOG PS, region, CA19-9 level (< 1000 IU/mL or >/=1000 IU/mL), and RT during trial (yes or no).||Using a 1-sided alpha=0.2, a population of 200 participants (100 GEM plus dasatinib and 100 GEM plus placebo) has 79% power to show an increase in median OS from 10 to 13.3 months (hazard ratio [HR] =0.75, assuming analysis of 135 deaths).|
1669141|NCT01394991|3071939|Superiority or Other||Risk Difference (RD)|-0.003||||0.92|2-Sided|95.0|-0.071|0.065|||Chi-squared||||
1669142|NCT01394991|3071940|Superiority or Other||Risk Difference (RD)|0.026||||0.514|2-Sided|95.0|-0.056|0.108|||Chi-squared||||
1669143|NCT01394991|3071941|Superiority or Other||Risk Difference (RD)|0.0041||||0.88||95.0|-0.0526|0.0608|||Chi-squared||||
1669144|NCT01394991|3071942|Superiority or Other||Hazard Ratio (HR)|0.47||||0.054|2-Sided|95.0|0.21|1.03|||Log Rank|The stratified log-rank test accounting for ECOG score status (0 or 1 versus 2) was used to compare the difference between treatment groups.|The Cox regression model including covariates for treatment group and the Eastern Cooperative Oncology Group (ECOG) score status (0 or 1 versus 2) was used for estimates of a hazard ratio and its 95% confidence interval.||
1669145|NCT01394991|3071943|Superiority or Other||Risk Difference (RD)|-0.039||||0.059||95.0|-0.083|0.005|||Chi-squared||||
1669146|NCT01394991|3071944|Superiority or Other||Hazard Ratio (HR)|0.4||||0.073|2-Sided|95.0|0.14|1.13|||Log Rank|The stratified log-rank test accounting for ECOG performance status (0 or 1 versus 2) was used to compare the difference between treatment groups.|The Cox regression model with covariates for treatment group and Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 versus 2) was used for estimates of hazard ratio and its 95% confidence interval.||
1669147|NCT01394991|3071945|Superiority or Other||Risk Difference (RD)|-0.029||||0.08|2-Sided|95.0|-0.065|0.007|||Chi-squared||||
1669148|NCT01394991|3071946|Superiority or Other||Odds Ratio (OR)|0.53||||0.254||95.0|0.18|1.58|||Regression, Logistic||||
1669149|NCT01394991|3071946|Superiority or Other||Risk Difference (RD)|-0.018||||0.248|2-Sided|95.0|-0.051|0.016|||Chi-squared|||The primary hypothesis was that the group of participants receiving epoetin alfa QW and the group of participants receiving epoetin alfa TIW would have similar incidence rate of participants with at least 1 clinically relevant and objectively confirmed TVE from randomization through Week 16.|
1669150|NCT01394952|3071948|Superiority|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|1.14||||0.413|2-Sided|95.0|0.84|1.54|||Regression, Cox|||Hospitalization for unstable angina|
1669151|NCT01394952|3071949|Superiority|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.93||||0.456|2-Sided|95.0|0.77|1.12|||Regression, Cox|||Heart failure requiring hospitalization or an urgent heart failure clinic visit|
1669152|NCT01394952|3071950|Superiority|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.86|||<|0.001|2-Sided|95.0|0.79|0.93|||Regression, Cox|||microvascular endpoint|
1669153|NCT01394952|3071951|Superiority|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.9||||0.067|2-Sided|95.0|0.8|1.01|||Regression, Cox|||Time to all cause mortality|
1669154|NCT01394952|3071952|Superiority|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.76||||0.017|2-Sided|95.0|0.61|0.95|||Regression, Cox|||Nonfatal stroke|
1669189|NCT01393964|3072022|Superiority or Other||ratio of adjusted means|100.454||||0.965|2-Sided|90.0|84.453|119.488|||ANOVA|||The reference arm is NRF participants.|
1669155|NCT01394952|3071952|Superiority|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.96||||0.652|2-Sided|95.0|0.79|1.16|||Regression, Cox|||Nonfatal MI|
1669156|NCT01394952|3071952|Superiority|Multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467.|Hazard Ratio (HR)|0.91||||0.211|2-Sided|95.0|0.78|1.06|||Regression, Cox|||Death from CV causes|
1669157|NCT01394952|3071953|Superiority|"Superiority was declared if the upper limit of the 2-sided 95.33% confidence interval (CI) of the hazard ratio was below 1.0 (after adjustment for the interim analysis).~Once superiority was achieved for the primary endpoint, multiplicity adjustments using the graphical approach were performed for secondary efficacy endpoints in order to control the overall Type I error rate at a 2-sided alpha level of 0.0467."|Hazard Ratio (HR)|0.88||||0.026|2-Sided|95.33|0.79|0.99|||Regression, Cox|||Primary CV endpoint|
1669158|NCT01394705|3071960|Superiority|||||||0.76|||||||Wilcoxon (Mann-Whitney)||||
1669159|NCT01394705|3071961|Superiority|||||||0.65|||||||Wilcoxon (Mann-Whitney)||||
1669160|NCT01394705|3071961|Superiority|||||||0.65|||||||Fisher Exact||||
1669161|NCT01394614|3071968|Superiority or Other||Risk Ratio (RR)|4.32|||||2-Sided|95.0|1.5|11.12|||||Risk of developing narcolepsy if exposed to H1N1 vaccination (using the 16-week post-vaccination period as reference).||
1669162|NCT01394614|3071968|Superiority or Other||Incidence-rate difference|0.41|||||2-Sided||||||||Difference between the incidence rate of exposed-to-vaccine cases (0.52) and that of unexposed cases (0.11) is 0.41 per 100,000 persons-years||
1669163|NCT01394276|3071973|Superiority or Other||Mean Difference (Net)|0.1||||0.6696|2-Sided|95.0|0.0|0.3|||t-test, 2 sided|||At Month 12: mean difference of scores of HAQ between the two groups was calculated.|
1669164|NCT01394276|3071973|Superiority or Other||Mean Difference (Net)|0.0||||0.9639|2-Sided|95.0|0.0|0.2|||t-test, 2 sided|||At Month 6: mean difference of scores of HAQ between the two groups was calculated.|
1669165|NCT01394276|3071973|Superiority or Other||Mean Difference (Net)|-0.1||||0.2468|2-Sided|95.0|0.0|0.1|||t-test, 2 sided|||At Month 4: mean difference of scores of HAQ between the two groups was calculated.|
1669166|NCT01394276|3071973|Superiority or Other||Mean Difference (Net)|0.0||||0.4932|2-Sided|95.0|0.0|0.2|||t-test, 2 sided|||At Month 2: mean difference of scores of HAQ between the two groups was calculated.|
1669167|NCT01394276|3071973|Superiority or Other||Mean Difference (Net)|0.0||||0.1098|2-Sided|95.0|0.0|0.0|||t-test, 2 sided|||At Month 1: mean difference of scores of HAQ between the two groups was calculated.|
1669168|NCT01394276|3071973|Superiority or Other||Mean Difference (Net)|0.0||||0.7343|2-Sided|95.0|0.0|0.2|||t-test, 2 sided|||At Baseline: mean difference of scores of HAQ between the two groups was calculated.|
1669169|NCT01394276|3071974|Superiority or Other||Mean Difference (Net)|3.9||||0.354|2-Sided|95.0|0.0|12.1|||t-test, 2 sided|||At Month 12: mean difference of scores of fatigue between the two groups was calculated.|
1669170|NCT01394276|3071974|Superiority or Other||Mean Difference (Net)|13.7||||0.0025|2-Sided|95.0|4.9|22.6|||t-test, 2 sided|||At Month 6: mean difference of scores of fatigue between the two groups was calculated.|
1669171|NCT01394276|3071974|Superiority or Other||Mean Difference (Net)|2.8||||0.5182|2-Sided|95.0|0.0|11.4|||t-test, 2 sided|||At Month 4: mean difference of scores of fatigue between the two groups was calculated.|
1669172|NCT01394276|3071974|Superiority or Other||Mean Difference (Net)|6.4||||0.1817|2-Sided|95.0|-3.0|15.9|||t-test, 2 sided|||At Month 2: mean difference of scores of fatigue between the two groups was calculated.|
1669173|NCT01394276|3071974|Superiority or Other||Mean Difference (Net)|2.1||||0.6749|2-Sided|95.0|0.0|12.1|||t-test, 2 sided|||At Month 1: mean difference of scores of fatigue between the two groups was calculated.|
1669174|NCT01394276|3071974|Superiority or Other||Mean Difference (Net)|3.5||||0.4211|2-Sided|95.0|0.0|12.2|||t-test, 2 sided|||At Baseline: mean difference of scores of fatigue between the two groups was calculated.|
1669175|NCT01394276|3071975|Superiority or Other||Mean Difference (Net)|0.1||||0.5832|2-Sided|95.0|-0.3|0.5|||t-test, 2 sided|||At Month 12: mean difference of scores of DAS28 between the two groups was calculated.|
1669176|NCT01394276|3071975|Superiority or Other||Mean Difference (Net)|0.0||||0.9721|2-Sided|95.0|-0.4|0.3|||t-test, 2 sided|||At Month 6: mean difference of scores of DAS28 between the two groups was calculated.|
1669177|NCT01394276|3071975|Superiority or Other||Mean Difference (Net)|0.0||||0.8181|2-Sided|95.0|-0.4|0.3|||t-test, 2 sided|||At Month 4: mean difference of scores of DAS28 between the two groups was calculated.|
1669178|NCT01394276|3071975|Superiority or Other||Mean Difference (Net)|-0.3||||0.0947|2-Sided|95.0|-0.7|0.1|||t-test, 2 sided|||At Month 2: mean difference of scores of DAS28 between the two groups was calculated.|
1669179|NCT01394276|3071975|Superiority or Other||Mean Difference (Net)|-0.1||||0.4884|2-Sided|95.0|-0.5|0.3|||t-test, 2 sided|||At Month 1: mean difference of scores of DAS28 between the two groups was calculated.|
1669180|NCT01394276|3071975|Superiority or Other||Mean Difference (Net)|0.0||||0.808|2-Sided|95.0|-0.3|0.4|||t-test, 2 sided|||At Baseline: mean difference of scores of DAS28 between the two groups was calculated.|
1669181|NCT01394276|3071987|Superiority or Other|||||||0.0003|||||||Exact binomial proportion test||||
1669182|NCT01394276|3071988|Superiority or Other|||||||0.0237|||||||Exact binomial proportion test||||
1669183|NCT01394081|3071999|Superiority||||||<|0.0001|||||||Log Rank|log rank Mantel Cox χ2 = 25.4|||
1669184|NCT01394081|3072000|Superiority||||||<|0.0001|||||||Chi-squared, Corrected||||
1669185|NCT01393964|3072021|Superiority or Other||Ratio of Adjusted Means|110.4||||0.642|2-Sided|90.0|76.825|158.647|||ANOVA|||AUC(INF). The reference arm is NRF participants.|
1669186|NCT01393964|3072021|Superiority or Other||Ratio of Adjusted Means|129.858||||0.228|2-Sided|90.0|90.366|186.609|||ANOVA|||AUC (INF). The reference arm is NRF participants.|
1669187|NCT01393964|3072021|Superiority or Other||Ratio of Adjusted Means|116.123||||0.355|2-Sided|90.0|88.458|152.439|||ANOVA|||AUC(0-T). The reference arm is NRF participants.|
1669188|NCT01393964|3072021|Superiority or Other||Ratio of Adjusted Means|126.596||||0.164|2-Sided|90.0|95.52|167.783|||ANOVA|||AUC(0-T). The reference arm is NRF participants.|
1669190|NCT01393964|3072022|Superiority or Other||Ratio of Adjusted Means|104.096||||0.704|2-Sided|90.0|86.983|124.576|||ANOVA|||The reference arm is NRF participants.|
1669191|NCT01393899|3072024|Superiority or Other||Adjusted Mean Difference|-1.2|||<|0.0001|2-Sided|95.0|-1.72|-0.67|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26|
1669192|NCT01393899|3072024|Superiority or Other||Adjusted Mean Difference|-0.66|||=|0|2-Sided|95.0|-1.06|-0.25|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12|
1669193|NCT01393899|3072024|Superiority or Other||Adjusted Mean Difference|-0.57|||=|0|2-Sided|95.0|-0.96|-0.18|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8|
1669194|NCT01393899|3072024|Superiority or Other||Adjusted Mean Difference|-0.56|||=|0|2-Sided|95.0|-1.1|-0.02|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26|
1669195|NCT01393899|3072024|Superiority or Other||Adjusted Mean Difference|-0.21|||=|0|2-Sided|95.0|-0.61|0.2|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12|
1669196|NCT01393899|3072024|Superiority or Other||Adjusted Mean Difference|-0.39|||=|0|2-Sided|95.0|-0.79|0.01|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8|
1669197|NCT01393899|3072026|Superiority or Other||Adjusted Mean Difference|-1.62|||<|0.0001|2-Sided|95.0|-2.3|-0.95|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26|
1669198|NCT01393899|3072026|Superiority or Other||Adjusted Mean Difference|-1.3|||<|0.0001|2-Sided|95.0|-1.87|-0.74|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20|
1669199|NCT01393899|3072026|Superiority or Other||Adjusted Mean Difference|-1.23|||<|0.0001|2-Sided|95.0|-1.75|-0.71|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12|
1669200|NCT01393899|3072026|Superiority or Other||Adjusted Mean Difference|-0.92|||=|0|2-Sided|95.0|-1.4|-0.45|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8|
1669201|NCT01393899|3072026|Superiority or Other||Adjusted Mean Difference|-0.92|||<|0.0001|2-Sided|95.0|-1.32|-0.52|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4|
1669202|NCT01393899|3072026|Superiority or Other||Adjusted Mean Difference|-0.61|||=|0|2-Sided|95.0|-1.31|0.09|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26|
1669203|NCT01393899|3072026|Superiority or Other||Adjusted Mean Difference|-0.56|||=|0|2-Sided|95.0|-1.13|0.02|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20|
1669204|NCT01393899|3072026|Superiority or Other||Adjusted Mean Difference|-0.75|||=|0|2-Sided|95.0|-1.26|-0.24|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12|
1669205|NCT01393899|3072026|Superiority or Other||Adjusted Mean Difference|-0.76|||=|0|2-Sided|95.0|-1.24|-0.28|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8|
1669206|NCT01393899|3072026|Superiority or Other||Adjusted Mean Difference|-0.93|||<|0.0001|2-Sided|95.0|-1.34|-0.53|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4|
1669207|NCT01393899|3072028|Superiority or Other||Difference in Percentage|16.67|||||2-Sided|80.0|-4.15|37.49|||||||
1669208|NCT01393899|3072028|Superiority or Other||Difference in Percentage|10.61|||||2-Sided|80.0|-11.44|32.66|||||||
1669209|NCT01393899|3072029|Superiority or Other||Difference in Percentage|-26.28|||||2-Sided|80.0|-46.54|-6.02||||||Week 26|
1669210|NCT01393899|3072029|Superiority or Other||Difference in Percentage|-12.9|||||2-Sided|80.0|-26.99|1.19||||||Week 20|
1669211|NCT01393899|3072029|Superiority or Other||Difference in Percentage|-8.09|||||2-Sided|80.0|-21.54|5.36||||||Week 12|
1669212|NCT01393899|3072029|Superiority or Other||Difference in Percentage|1.61|||||2-Sided|80.0|-10.14|13.36||||||Week 8|
1669213|NCT01393899|3072029|Superiority or Other||Difference in Percentage|-2.96|||||2-Sided|80.0|-12.39|6.48||||||Week 4|
1669214|NCT01393899|3072029|Superiority or Other||Difference in Percentage|-18.9|||||2-Sided|80.0|-39.52|1.72||||||Week 26|
1669215|NCT01393899|3072029|Superiority or Other||Difference in Percentage|-12.73|||||2-Sided|80.0|-26.81|1.34||||||Week 20|
1669216|NCT01393899|3072029|Superiority or Other||Difference in Percentage|-12.48|||||2-Sided|80.0|-25.68|0.72||||||Week 12|
1669217|NCT01393899|3072029|Superiority or Other||Difference in Percentage|-7.43|||||2-Sided|80.0|-18.27|3.41||||||Week 8|
1669218|NCT01393899|3072029|Superiority or Other||Difference in Percentage|-7.44|||||2-Sided|80.0|-16.14|1.26||||||Week 4|
1669219|NCT01393899|3072030|Superiority or Other||Adjusted Mean Difference|-50.38|||=|0|2-Sided|80.0|-88.03|-12.72|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26|
1669220|NCT01393899|3072030|Superiority or Other||Adjusted Mean Difference|-47.74|||=|0|2-Sided|80.0|-88.62|-6.87|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20|
1669221|NCT01393899|3072030|Superiority or Other||Adjusted Mean Difference|-37.0|||=|0|2-Sided|80.0|-73.57|-0.42|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12|
1669222|NCT01393899|3072030|Superiority or Other||Adjusted Mean Difference|-9.61|||=|0|2-Sided|80.0|-36.03|16.81|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8|
1669223|NCT01393899|3072030|Superiority or Other||Adjusted Mean Difference|-23.56|||=|0|2-Sided|80.0|-44.27|-2.85|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4|
1669224|NCT01393899|3072030|Superiority or Other||Adjusted Mean Difference|-6.0|||=|0|2-Sided|80.0|-44.22|32.21|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 26|
1669225|NCT01393899|3072030|Superiority or Other||Adjusted Mean Dofference|-18.01|||=|0|2-Sided|80.0|-59.01|22.99|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 20|
1669226|NCT01393899|3072030|Superiority or Other||Adjusted Mean Difference|-42.52|||=|0|2-Sided|80.0|-78.57|-6.48|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 12|
1669227|NCT01393899|3072030|Superiority or Other||Adjusted Mean Difference|-21.06|||=|0|2-Sided|80.0|-47.43|5.31|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 8|
1669228|NCT01393899|3072030|Superiority or Other||Adjusted Mean Difference|-30.26|||=|0|2-Sided|80.0|-51.1|-9.42|||Linear mixed-effects model||Parameter Type: Adjusted Mean Difference|Week 4|
1669229|NCT01393899|3072032|Superiority or Other||Difference in Percentage|17.83|||||2-Sided|80.0|4.33|31.33|||||||
1669230|NCT01393899|3072032|Superiority or Other||Difference in Percentage|-7.75|||||2-Sided|80.0|-20.39|4.88|||||||
1669231|NCT01393899|3072033|Superiority or Other||Difference in Percentage|18.11|||||2-Sided|80.0|5.57|30.64|||||||
1669232|NCT01393899|3072033|Superiority or Other||Difference in Percentage|1.83|||||2-Sided|80.0|-9.75|13.4|||||||
1669233|NCT01393899|3072034|Superiority or Other||Difference in Percentage|22.0|||||2-Sided|80.0|4.96|39.04||||||Week 26|
1669234|NCT01393899|3072034|Superiority or Other||Difference in Percentage|10.15|||||2-Sided|80.0|-7.41|27.71||||||Week 20|
1669235|NCT01393899|3072034|Superiority or Other||Difference in Percentage|2.31|||||2-Sided|80.0|-15.35|19.97||||||Week 12|
1669236|NCT01393899|3072034|Superiority or Other||Difference in Percentage|-14.0|||||2-Sided|80.0|-31.59|3.59||||||Week 8|
1669237|NCT01393899|3072034|Superiority or Other||Difference in Percentage|8.77|||||2-Sided|80.0|-6.41|23.95||||||Week 4|
1669238|NCT01393899|3072034|Superiority or Other||Difference in Percentage|11.29|||||2-Sided|80.0|-5.22|27.79||||||Week 26|
1669239|NCT01393899|3072034|Superiority or Other||Difference in Percentage|6.86|||||2-Sided|80.0|-10.32|24.03||||||Week 20|
1669240|NCT01393899|3072034|Superiority or Other||Difference in Percentage|24.29|||||2-Sided|80.0|7.19|41.38||||||Week 12|
1669241|NCT01393899|3072034|Superiority or Other||Difference in Percentage|0.29|||||2-Sided|80.0|-16.63|17.2||||||Week 8|
1669242|NCT01393899|3072034|Superiority or Other||Difference in Percentage|6.57|||||2-Sided|80.0|-8.63|21.78||||||Week 4|
1669243|NCT01393899|3072035|Superiority or Other||Difference in Percentage|13.29|||||2-Sided|80.0|0.15|26.43||||||Week 26|
1669244|NCT01393899|3072035|Superiority or Other||Difference in Percentage|8.58|||||2-Sided|80.0|-4.64|21.81||||||Week 20|
1669245|NCT01393899|3072035|Superiority or Other||Difference in Percentage|1.55|||||2-Sided|80.0|-11.63|14.73||||||Week 12|
1669246|NCT01393899|3072035|Superiority or Other||Difference in Percentage|-8.08|||||2-Sided|80.0|-21.83|5.66||||||Week 8|
1669247|NCT01393899|3072035|Superiority or Other||Difference in Percentage|5.76|||||2-Sided|80.0|-8.04|19.56||||||Week 4|
1669248|NCT01393899|3072035|Superiority or Other||Difference in Percentage|8.64|||||2-Sided|80.0|-4.36|21.64||||||Week 26|
1669249|NCT01393899|3072035|Superiority or Other||Difference in Percentage|1.61|||||2-Sided|80.0|-11.33|14.55||||||Week 20|
1669250|NCT01393899|3072035|Superiority or Other||Difference in Percentage|13.18|||||2-Sided|80.0|-0.31|26.67||||||Week 12|
1669251|NCT01393899|3072035|Superiority or Other||Difference in Percentage|1.22|||||2-Sided|80.0|-12.67|15.11||||||Week 8|
1669252|NCT01393899|3072035|Superiority or Other||Difference in Percentage|3.43|||||2-Sided|80.0|-10.41|17.28||||||Week 4|
1669253|NCT01393899|3072036|Superiority or Other||Difference in Percentage|20.1|||||2-Sided|80.0|6.54|33.66||||||Week 26|
1669254|NCT01393899|3072036|Superiority or Other||Difference in Percentage|13.07|||||2-Sided|80.0|-0.63|26.77||||||Week 20|
1669255|NCT01393899|3072036|Superiority or Other||Difference in Percentage|1.16|||||2-Sided|80.0|-12.74|15.06||||||Week 12|
1669256|NCT01393899|3072036|Superiority or Other||Difference in Percentage|-8.53|||||2-Sided|80.0|-21.94|4.88||||||Week 8|
1669257|NCT01393899|3072036|Superiority or Other||Difference in Percentage|2.93|||||2-Sided|80.0|-9.06|14.92||||||Week 4|
1669258|NCT01393899|3072036|Superiority or Other||Difference in Percentage|1.5|||||2-Sided|80.0|-11.88|14.87||||||Week 26|
1669259|NCT01393899|3072036|Superiority or Other||Difference in Percentage|1.44|||||2-Sided|80.0|-12.11|14.99||||||Week 20|
1669260|NCT01393899|3072036|Superiority or Other||Difference in Percentage|5.81|||||2-Sided|80.0|-8.04|19.67||||||Week 12|
1669261|NCT01393899|3072036|Superiority or Other||Difference in Percentage|-3.88|||||2-Sided|80.0|-17.15|9.4||||||Week 8|
1669262|NCT01393899|3072036|Superiority or Other||Difference in Percentage|-1.72|||||2-Sided|80.0|-14.06|10.63||||||Week 4|
1669263|NCT01393899|3072037|Superiority or Other||Difference in Percentage|10.69|||||2-Sided|80.0|-3.08|24.46||||||Week 20|
1669264|NCT01393899|3072037|Superiority or Other||Difference in Percentage|3.49|||||2-Sided|80.0|-10.4|17.37||||||Week 12|
1669265|NCT01393899|3072037|Superiority or Other||Difference in Percentage|-8.53|||||2-Sided|80.0|-21.94|4.88||||||Week 8|
1669266|NCT01393899|3072037|Superiority or Other||Difference in Percentage|5.26|||||2-Sided|80.0|-6.52|17.04||||||Week 4|
1669267|NCT01393899|3072037|Superiority or Other||Difference in Percentage|-0.94|||||2-Sided|80.0|-14.56|12.68||||||Week 20|
1669268|NCT01393899|3072037|Superiority or Other||Difference in Percentage|5.81|||||2-Sided|80.0|-8.04|19.67||||||Week 12|
1669269|NCT01393899|3072037|Superiority or Other||Difference in Percentage|0.78|||||2-Sided|80.0|-12.29|13.84||||||Week 8|
1669270|NCT01393899|3072037|Superiority or Other||Difference in Percentage|0.61|||||2-Sided|80.0|-11.57|12.79||||||Week 4|
1669271|NCT01393899|3072038|Superiority or Other||Difference in Percentage|17.72|||||2-Sided|80.0|4.07|31.37|||||||
1669272|NCT01393899|3072038|Superiority or Other||Difference in Percentage|1.44|||||2-Sided|80.0|-12.11|14.99|||||||
1669273|NCT01393821|3072042|Superiority|||||||0.6311|||||||Kruskal-Wallis||||
1669274|NCT01393743|3072046|Superiority or Other|||||||0.3694|||||||Cochran-Mantel-Haenszel|||P Value Compared to Placebo for Myoclonic Seizures|
1669275|NCT01393743|3072046|Superiority or Other|||||||0.4653|||||||Cochran-Mantel-Haenszel|||P Value Compared to Placebo for Absence Seizures|
1669276|NCT01393743|3072047|Superiority or Other|||||||0.1826||||||The P value is based on non-missing values and is from a Cochran-Mantel-Haenszel test stratified by pooled country.|Cochran-Mantel-Haenszel||||
1669277|NCT01393743|3072048|Superiority or Other||Mean Difference (Final Values)|24.87||||0.61|2-Sided|95.0|-15.338|59.938|||ANCOVA|||Median Difference to Placebo for Myoclonic Seizure|
1669605|NCT01392300|3072250|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.08||0.018|2-Sided|95.0|-0.3|0.0|||ANCOVA||||
1669606|NCT01392300|3072251|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.07||0.007|2-Sided|95.0|-0.4|-0.1|||ANCOVA||||
1669278|NCT01393743|3072048|Superiority or Other||Median Difference (Final Values)|-12.25||||0.3478|2-Sided|95.0|-53.054|26.989||The P value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|Median Difference to Placebo for Absence Seizures|
1669279|NCT01393743|3072049|Superiority or Other||Median Difference (Final Values)|-23.45||||0.0018|2-Sided|95.0|-40.668|-8.518||The P value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA|||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|
1669280|NCT01393743|3072051|Superiority or Other|||||||0.0019||||||The P value is based on non-missing values and is from a Cochran-Mantel-Haenszel test stratified by pooled country.|Cochran-Mantel-Haenszel||||
1669281|NCT01393743|3072052|Superiority or Other||Median Difference (Final Values)|-30.81||||0.0001|2-Sided|95.0|-45.49|-15.244||The P-value is based on a rank analysis of covariance with treatment and pooled country as factors, and prerandomization seizure frequency as a covariate.|ANCOVA|||The median difference to placebo and the 95% confidence interval are based on the Hodges-Lehmann method.|
1669282|NCT01393626|3072093|Superiority or Other||Mean Difference (Final Values)|6.36||||0.3916|2-Sided|95.0|-8.09|20.8|||Cochran-Mantel-Haenszel|||Tofacitinib-Placebo|
1669283|NCT01393626|3072093|Superiority or Other||Mean Difference (Final Values)|6.86||||0.3249|2-Sided|95.0|-7.64|21.36|||Cochran-Mantel-Haenszel|||Tofacitinib-Placebo|
1669284|NCT01393613|3072094|Superiority or Other||Mean Difference (Final Values)|-0.64||||0.089|2-Sided|95.0|-1.39|0.1|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.|
1669285|NCT01393613|3072094|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.0373|2-Sided|95.0|-1.35|-0.04|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669286|NCT01393613|3072094|Superiority or Other||Mean Difference (Final Values)|-0.86||||0.0104|2-Sided|95.0|-1.51|-0.2|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.|
1669287|NCT01393613|3072095|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.5752|2-Sided|95.0|-1.16|0.65|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.|
1669288|NCT01393613|3072095|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.6792|2-Sided|95.0|-0.97|0.63|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669289|NCT01393613|3072095|Superiority or Other||Mean Difference (Final Values)|-1.26||||0.0021|2-Sided|95.0|-2.05|-0.46|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.|
1669290|NCT01393613|3072096|Superiority or Other||Mean Difference (Final Values)|-0.87||||0.115|2-Sided|95.0|-1.96|0.21|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.|
1669291|NCT01393613|3072096|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.4753|2-Sided|95.0|-1.31|0.61|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669292|NCT01393613|3072096|Superiority or Other||Mean Difference (Final Values)|-1.39||||0.0045|2-Sided|95.0|-2.34|-0.43|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6. Because only the comparison of brexpiprazole 4 mg/day versus placebo met the threshold in the primary analysis, the following analysis is not part for the formal statistical testing and is descriptive only.|
1669293|NCT01393613|3072097|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.108|2-Sided|95.0|-2.22|0.22|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.|
1669294|NCT01393613|3072097|Superiority or Other||Mean Difference (Final Values)|-0.98||||0.0754|2-Sided|95.0|-2.06|0.1|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669295|NCT01393613|3072097|Superiority or Other||Mean Difference (Final Values)|-1.28||||0.0194|2-Sided|95.0|-2.36|-0.21|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.|
1669296|NCT01393613|3072098|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.4423|2-Sided|95.0|-2.32|1.01|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.|
1669297|NCT01393613|3072098|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.64|2-Sided|95.0|-1.83|1.12|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669298|NCT01393613|3072098|Superiority or Other||Mean Difference (Final Values)|-1.14||||0.1273|2-Sided|95.0|-2.61|0.33|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.|
1669299|NCT01393613|3072099|Superiority or Other||Mean Difference (Final Values)|-0.48||||0.3646|2-Sided|95.0|-1.51|0.56|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.|
1669300|NCT01393613|3072099|Superiority or Other||Mean Difference (Final Values)|-0.43||||0.3559|2-Sided|95.0|-1.34|0.48|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669301|NCT01393613|3072099|Superiority or Other||Mean Difference (Final Values)|-1.39||||0.0029|2-Sided|95.0|-2.3|-0.48|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.|
1669302|NCT01393613|3072100|Superiority or Other||Relative Risk|0.76||||0.4586|2-Sided|95.0|0.36|1.59|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.|
1669303|NCT01393613|3072100|Superiority or Other||Relative Risk|1.0||||0.9894|2-Sided|95.0|0.55|1.85|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669304|NCT01393613|3072100|Superiority or Other||Relative Risk|0.82||||0.5202|2-Sided|95.0|0.44|1.51|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.|
1669305|NCT01393613|3072101|Superiority or Other||Relative Risk|1.35||||0.0433|2-Sided|95.0|1.02|1.79|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.|
1669306|NCT01393613|3072101|Superiority or Other||Relative Risk|1.22||||0.168|2-Sided|95.0|0.92|1.62|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669307|NCT01393613|3072101|Superiority or Other||Relative Risk|1.54||||0.0006|2-Sided|95.0|1.2|2.0|||Cochran-Mantel-Haenszel|CMH general association test||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.|
1669308|NCT01393613|3072102|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.1358|2-Sided|95.0|-0.56|0.08|||Cochran-Mantel-Haenszel|CMH row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.|
1669309|NCT01393613|3072102|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.0422|2-Sided|95.0|-0.6|-0.01|||Cochran-Mantel-Haenszel|CMH row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669310|NCT01393613|3072102|Superiority or Other||Mean Difference (Final Values)|-0.49||||0.0009|2-Sided|95.0|-0.78|-0.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenzel (CMH) row mean scores differ test controlling for study center.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.|
1669311|NCT01393613|3072103|Superiority or Other||Mean Difference (Final Values)|-0.78||||0.2004|2-Sided|95.0|-1.98|0.42|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.|
1669312|NCT01393613|3072103|Superiority or Other||Mean Difference (Final Values)|-0.77||||0.1547|2-Sided|95.0|-1.83|0.29|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669313|NCT01393613|3072103|Superiority or Other||Mean Difference (Final Values)|-1.22||||0.0231|2-Sided|95.0|-2.28|-0.17|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.|
1669314|NCT01393613|3072104|Superiority or Other||Mean Difference (Final Values)|-0.68||||0.3938|2-Sided|95.0|-2.26|0.89|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.|
1669315|NCT01393613|3072104|Superiority or Other||Mean Difference (Final Values)|-0.47||||0.5101|2-Sided|95.0|-1.86|0.93|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669316|NCT01393613|3072104|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.0166|2-Sided|95.0|-3.08|-0.31|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.|
1669317|NCT01393613|3072105|Superiority or Other||Mean Difference (Final Values)|3.21||||0.0332|2-Sided|95.0|0.26|6.16|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.|
1669318|NCT01393613|3072105|Superiority or Other||Mean Difference (Final Values)|2.0||||0.1286|2-Sided|95.0|-0.58|4.59|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669607|NCT01392300|3072252|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.08||0.14|2-Sided|95.0|-0.3|0.0|||ANCOVA||||
1669787|NCT01389856|3072566|Superiority or Other|||||||0.1155|||||||Non-parametric ANCOVA||||
1669319|NCT01393613|3072105|Superiority or Other||Mean Difference (Final Values)|4.59||||0.0005|2-Sided|95.0|2.02|7.17|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.|
1669320|NCT01393613|3072106|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.4449|2-Sided|95.0|-0.37|0.16|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6.|
1669321|NCT01393613|3072106|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.1269|2-Sided|95.0|-0.42|-0.05|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669322|NCT01393613|3072106|Superiority or Other||Mean Difference (Final Values)|-0.38||||0.0015|2-Sided|95.0|-0.62|-0.15|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6. The analysis of this key secondary endpoint was conducted if both comparisons of brexpiprazole 4 mg/day vs placebo and brexpiprazole 2 mg/day vs placebo of the primary endpoint were significant. Because only the comparison of brexpiprazole 4 mg/day vs placebo met the threshold in the primary analysis, the following analysis is not part of the formal statistical testing and is descriptive only.|
1669323|NCT01393613|3072106|Superiority or Other|||||||0.0069|||||||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare the average effect analysis for brexpiprazole 2 mg/day and 4 mg/day and placebo combined treatment groups at Week 6.|
1669324|NCT01393613|3072107|Superiority or Other||Mean Difference (Final Values)|-3.37||||0.1588|2-Sided|95.0|-8.06|1.32|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 1mg/day and placebo was performed at Week 6. MMRM analysis fixed effect of treatment, clinical visit, trial site, treatment visit interaction, Baseline value, and Baseline visit interaction as covariates.|
1669325|NCT01393613|3072107|Superiority or Other||Mean Difference (Final Values)|-3.08||||0.1448|2-Sided|95.0|-7.23|1.07|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 2mg/day and placebo was performed at Week 6.|
1669326|NCT01393613|3072107|Superiority or Other||Mean Difference (Final Values)|-6.47||||0.0022|2-Sided|95.0|-10.6|-2.35|||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare brexpiprazole 4mg/day and placebo was performed at Week 6.|
1669327|NCT01393613|3072107|Superiority or Other|||||||0.0093|||||||Mixed Models Analysis|MMRM analysis fixed effect of treatment, trial site, visit, treatment visit interaction, Baseline value, Baseline visit interaction as covariates.||Statistical analysis to compare the average effect analysis for brexpiprazole 2 mg/day and 4 mg/day and placebo combined treatment groups at Week 6. The primary analysis was performed by fitting a Mixed Model Repeated Measures (MMRM) with an unstructured variance covariance structure. The model included fixed class effect terms for treatment, trial site, visit week, baseline, baseline and visit interaction and an interaction term of treatment by visit week.|
1669328|NCT01393600|3072108|Other||Mean Difference (Final Values)|-4.2|Standard Error of the Mean|1.1||0.0015|2-Sided|95.0|-6.6|-1.8|||ANOVA||||
1669329|NCT01393600|3072108|Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|1.0||0.6761|2-Sided|95.0|-2.4|1.6|||ANOVA||||
1669330|NCT01393600|3072110|Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|1.3||0.4184|2-Sided|95.0|-3.8|1.6|||ANOVA||||
1669331|NCT01393600|3072110|Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|1.3||0.588|2-Sided|95.0|-3.3|1.9|||ANOVA||||
1669332|NCT01393132|3072136|Superiority or Other|||||||0.0162|||||||t-test, 2 sided|||Comparison of Tear Film Break up Time between the placebo and Thymosin beta 4 groups.|
1669333|NCT01393132|3072137|Superiority or Other|||||||0.0141|||||||t-test, 2 sided|||Comparison of Ocular Discomfort Index score between the placebo and Thymosin beta 4 groups|
1669334|NCT01393132|3072138|Superiority or Other|||||||0.0108|||||||t-test, 2 sided|||Comparison of fluorescein staining score between the placebo and Thymosin beta 4 groups|
1669335|NCT01392963|3072160|Other|||||||0.001|||||||Mixed Models Analysis||||
1669336|NCT01392742|3072165|Superiority or Other|||||||0.042|||||||Regression, Logistic|||Binary logistic regression for treatment duration at Week 12.|
1669337|NCT01392742|3072165|Superiority or Other|||||||0.001|||||||Regression, Logistic|||Binary logistic regression for height at Week 12.|
1669338|NCT01392742|3072165|Superiority or Other|||||||0.092|||||||Regression, Logistic|||Binary logistic regression for liver fibrosis at Week 12.|
1669339|NCT01392742|3072165|Superiority or Other|||||||0.018|||||||Regression, Logistic|||Binary logistic regression for gender at Week 12.|
1669340|NCT01392742|3072165|Superiority or Other|||||||0.037|||||||Regression, Logistic|||Binary logistic regression for EVR at Week 12.|
1669341|NCT01392742|3072165|Superiority or Other|||||||0.001|||||||Regression, Logistic|||Binary logistic regression for treatment duration at Week 4.|
1669342|NCT01392742|3072165|Superiority or Other|||||||0.001|||||||Regression, Logistic|||Binary logistic regression for height at Week 4.|
1669343|NCT01392742|3072165|Superiority or Other|||||||0.05|||||||Regression, Logistic|||Binary logistic regression for HCV genotype at Week 4.|
1669344|NCT01392742|3072165|Superiority or Other|||||||0.062|||||||Regression, Logistic|||Binary logistic regression for liver fibrosis at Week 4.|
1669345|NCT01392742|3072165|Superiority or Other|||||||0.018|||||||Regression, Linear|||Binary logistic regression for gender at Week 4.|
1669346|NCT01392742|3072165|Superiority or Other|||||||0|||||||Regression, Logistic|||Binary logistic regression for RVR at Week 4.|
1669347|NCT01392677|3072181|Superiority or Other||Mean Difference (Final Values)|-3.76|Standard Error of the Mean|1.6677||0.025|2-Sided|95.0|-7.05|-0.48||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1669348|NCT01392677|3072182|Superiority or Other||Risk Difference (RD)|20.7|Standard Error of the Mean|5.056|<|0.0001|2-Sided|95.0|10.7|30.6||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives|Regression, Logistic|Based on methodology of Zhang, Tsiatis & Davidian and Tsiatis, Davidian, Zhang & Lu, with adjustment for baseline value||H0: proportion(treat) minus proportion (placebo) = 0 versus the alternative HA: proportion (treat) minus proportion (placebo) =/= 0|
1669349|NCT01392677|3072183|Superiority or Other||Mean Difference (Final Values)|-2.07|Standard Error of the Mean|0.3651|<|0.0001|2-Sided|95.0|-2.79|-1.35||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1669350|NCT01392677|3072184|Superiority or Other||Mean Difference (Final Values)|-33.45|Standard Error of the Mean|4.8846|<|0.0001|2-Sided|95.0|-43.08|-23.82||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1669351|NCT01392677|3072185|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.1022|<|0.0001|2-Sided|95.0|-0.89|-0.49||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives|Mixed Models Analysis|Longitudinal repeated measures model using mixed model with treatment group, baseline value, week and week*treatment and week*baseline||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1669352|NCT01392573|3072193|Superiority or Other||Treatment contrast|-1.05|||<|0.0001|2-Sided|95.0|-1.25|-0.84|||ANCOVA|ANCOVA model with treatment, country and previous antidiabetic treatment as fixed effects and baseline HbA1c value as covariate|||
1669353|NCT01392560|3072194|Superiority or Other||Mean change from baseline|-2.4|Standard Error of the Mean|7.7||0.7585|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under hyperglycaemia condition for non-filterers|
1669354|NCT01392560|3072194|Superiority or Other||Mean change from baseline|9.0|Standard Error of the Mean|5.9||0.1524|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for non-hyperfilterers|
1669355|NCT01392560|3072194|Superiority or Other||Mean change from baseline|-44.5|Standard Error of the Mean|7.1|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under hyperglycaemia condition for hyperfilterers|
1669356|NCT01392560|3072194|Superiority or Other||Change from baseline|-33.4|Standard Error of the Mean|6.2|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for hyperfilterers|
1669357|NCT01392560|3072194|Superiority or Other||Mean change from baseline|-30.8|Standard Error of the Mean|6.2|<|0.0001|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test the difference between baseline and end of treatment under hyperglycaemia condition for all patients|
1669358|NCT01392560|3072194|Superiority or Other||Mean change from baseline|-19.6|Standard Error of the Mean|5.6|<|0.0011|||||||Paired t-test||Estimated value = mean of end of treatment - baseline|Test of the difference between baseline and end of treatment under euglycaemia condition for all patients|
1669359|NCT01392443|3072208|Other|||||||0.0007|||||||single-sample biniminal test||||
1669360|NCT01392378|3072218|Superiority or Other||GMT Ratio|0.96||||0.916|2-Sided|95.0|0.76|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669361|NCT01392378|3072218|Superiority or Other||GMT Ratio|0.98||||0.939|2-Sided|95.0|0.78|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669362|NCT01392378|3072218|Superiority or Other||GMT Ratio|0.84||||0.85|2-Sided|95.0|0.67|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669363|NCT01392378|3072218|Superiority or Other||GMT Ratio|0.97||||0.91|2-Sided|95.0|0.77|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669364|NCT01392378|3072218|Superiority or Other||GMT Ratio|0.98||||0.916|2-Sided|95.0|0.79|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669365|NCT01392378|3072218|Superiority or Other||GMT Ratio|0.95||||0.868|2-Sided|95.0|0.77|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669788|NCT01389856|3072567|Superiority or Other|||||||0.1756|||||||Non-parametric ANCOVA||||
1669366|NCT01392378|3072218|Superiority or Other||GMT Ratio|0.94||||0.85|2-Sided|95.0|0.76|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669367|NCT01392378|3072218|Superiority or Other||GMT Ratio|0.99||||0.91|2-Sided|95.0|0.79|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669368|NCT01392378|3072218|Superiority or Other||GMT Ratio|1.02||||0.916|2-Sided|95.0|0.81|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669369|NCT01392378|3072218|Superiority or Other||GMT Ratio|1.09||||0.868|2-Sided|95.0|0.87|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669370|NCT01392378|3072218|Superiority or Other||GMT Ratio|1.05||||0.85|2-Sided|95.0|0.83|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669371|NCT01392378|3072218|Superiority or Other||GMT Ratio|0.98||||0.91|2-Sided|95.0|0.78|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669372|NCT01392378|3072219|Superiority or Other||GMC Ratio|1.1||||0.916|2-Sided|95.0|0.8|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669373|NCT01392378|3072219|Superiority or Other||GMC Ratio|1.1||||0.868|2-Sided|95.0|0.8|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669374|NCT01392378|3072219|Superiority or Other||GMC Ratio|1.07||||0.85|2-Sided|95.0|0.78|1.48||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669375|NCT01392378|3072219|Superiority or Other||GMC Ratio|1.26||||0.869|2-Sided|95.0|0.9|1.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669376|NCT01392378|3072220|Superiority or Other||GMC Ratio|0.98||||0.916|2-Sided|95.0|0.87|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669377|NCT01392378|3072220|Superiority or Other||GMC Ratio|0.89||||0.394|2-Sided|95.0|0.79|0.99||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669378|NCT01392378|3072220|Superiority or Other||GMC Ratio|1.02||||0.85|2-Sided|95.0|0.91|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669379|NCT01392378|3072220|Superiority or Other||GMC Ratio|0.86||||0.149|2-Sided|95.0|0.76|0.97||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669380|NCT01392378|3072220|Superiority or Other||GMC Ratio|0.86||||0.279|2-Sided|95.0|0.75|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669381|NCT01392378|3072220|Superiority or Other||GMC Ratio|0.98||||0.939|2-Sided|95.0|0.86|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669382|NCT01392378|3072220|Superiority or Other||GMC Ratio|0.94||||0.85|2-Sided|95.0|0.82|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669383|NCT01392378|3072220|Superiority or Other||GMC Ratio|0.96||||0.91|2-Sided|95.0|0.83|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669789|NCT01389856|3072568|Superiority or Other|||||||0.2436|||||||Non-parametric ANCOVA||||
1669384|NCT01392378|3072221|Superiority or Other||GMC Ratio|0.92||||0.914|2-Sided|95.0|0.76|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669385|NCT01392378|3072221|Superiority or Other||GMC Ratio|0.93||||0.868|2-Sided|95.0|0.78|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669386|NCT01392378|3072221|Superiority or Other||GMC Ratio|0.91||||0.85|2-Sided|95.0|0.76|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669387|NCT01392378|3072221|Superiority or Other||GMC Ratio|0.92||||0.91|2-Sided|95.0|0.76|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669388|NCT01392378|3072221|Superiority or Other||GMC Ratio|0.92||||0.914|2-Sided|95.0|0.81|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669389|NCT01392378|3072221|Superiority or Other||GMC Ratio|1.06||||0.868|2-Sided|95.0|0.93|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669390|NCT01392378|3072221|Superiority or Other||GMC Ratio|1.01||||0.909|2-Sided|95.0|0.89|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669391|NCT01392378|3072221|Superiority or Other||GMC Ratio|0.99||||0.91|2-Sided|95.0|0.87|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669392|NCT01392378|3072221|Superiority or Other||GMC Ratio|0.99||||0.916|2-Sided|95.0|0.85|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669393|NCT01392378|3072221|Superiority or Other||GMC Ratio|1.0||||0.961|2-Sided|95.0|0.85|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669394|NCT01392378|3072221|Superiority or Other||GMC Ratio|1.04||||0.85|2-Sided|95.0|0.89|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669395|NCT01392378|3072221|Superiority or Other||GMC Ratio|1.05||||0.91|2-Sided|95.0|0.89|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669396|NCT01392378|3072222|Superiority or Other||GMC Ratio|0.87||||0.914|2-Sided|95.0|0.67|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669397|NCT01392378|3072222|Superiority or Other||GMC Ratio|0.92||||0.868|2-Sided|95.0|0.7|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669398|NCT01392378|3072222|Superiority or Other||GMC Ratio|1.04||||0.85|2-Sided|95.0|0.79|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669399|NCT01392378|3072222|Superiority or Other||GMC Ratio|1.08||||0.91|2-Sided|95.0|0.81|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669400|NCT01392378|3072223|Superiority or Other||GMT Ratio|0.95||||0.925|2-Sided|95.0|0.69|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669401|NCT01392378|3072223|Superiority or Other||GMT Ratio|1.12||||0.695|2-Sided|95.0|0.82|1.52||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669790|NCT01389856|3072569|Superiority or Other|||||||0.3936|||||||Non-parametric ANCOVA||||
1669402|NCT01392378|3072223|Superiority or Other||GMT Ratio|0.8||||0.343|2-Sided|95.0|0.59|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669403|NCT01392378|3072223|Superiority or Other||GMT Ratio|1.07||||0.813|2-Sided|95.0|0.78|1.46||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669404|NCT01392378|3072223|Superiority or Other||GMT Ratio|0.82||||0.408|2-Sided|95.0|0.58|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669405|NCT01392378|3072223|Superiority or Other||GMT Ratio|0.92||||0.695|2-Sided|95.0|0.66|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669406|NCT01392378|3072223|Superiority or Other||GMT Ratio|1.09||||0.837|2-Sided|95.0|0.8|1.5||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669407|NCT01392378|3072223|Superiority or Other||GMT Ratio|1.18||||0.808|2-Sided|95.0|0.85|1.65||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669408|NCT01392378|3072223|Superiority or Other||GMT Ratio|0.98||||0.961|2-Sided|95.0|0.71|1.36||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669409|NCT01392378|3072223|Superiority or Other||GMT Ratio|0.94||||0.695|2-Sided|95.0|0.68|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669410|NCT01392378|3072223|Superiority or Other||GMT Ratio|0.92||||0.837|2-Sided|95.0|0.68|1.25||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669411|NCT01392378|3072223|Superiority or Other||GMT Ratio|0.95||||0.813|2-Sided|95.0|0.69|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669412|NCT01392378|3072224|Superiority or Other||GMC Ratio|0.82||||0.408|2-Sided|95.0|0.6|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669413|NCT01392378|3072224|Superiority or Other||GMC Ratio|0.94||||0.695|2-Sided|95.0|0.69|1.28||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669414|NCT01392378|3072224|Superiority or Other||GMC Ratio|1.05||||0.837|2-Sided|95.0|0.77|1.44||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669415|NCT01392378|3072224|Superiority or Other||GMC Ratio|1.03||||0.85|2-Sided|95.0|0.75|1.42||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669416|NCT01392378|3072225|Superiority or Other||GMC Ratio|1.0||||0.961|2-Sided|95.0|0.87|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669417|NCT01392378|3072225|Superiority or Other||GMC Ratio|0.93||||0.534|2-Sided|95.0|0.81|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669418|NCT01392378|3072225|Superiority or Other||GMC Ratio|1.03||||0.837|2-Sided|95.0|0.9|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669419|NCT01392378|3072225|Superiority or Other||GMC Ratio|0.95||||0.813|2-Sided|95.0|0.82|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669420|NCT01392378|3072225|Superiority or Other||GMC Ratio|0.74||||0.001|2-Sided|95.0|0.63|0.87||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669421|NCT01392378|3072225|Superiority or Other||GMC Ratio|0.84||||0.104|2-Sided|95.0|0.72|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669422|NCT01392378|3072225|Superiority or Other||GMC Ratio|0.86||||0.206|2-Sided|95.0|0.74|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669423|NCT01392378|3072225|Superiority or Other||GMC Ratio|0.9||||0.712|2-Sided|95.0|0.77|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669424|NCT01392378|3072226|Superiority or Other||GMC Ratio|0.81||||0.085|2-Sided|95.0|0.67|0.97||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669425|NCT01392378|3072226|Superiority or Other||GMC Ratio|0.78||||0.066|2-Sided|95.0|0.65|0.93||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669426|NCT01392378|3072226|Superiority or Other||GMC Ratio|0.84||||0.206|2-Sided|95.0|0.7|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669427|NCT01392378|3072226|Superiority or Other||GMC Ratio|0.86||||0.712|2-Sided|95.0|0.72|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669428|NCT01392378|3072226|Superiority or Other||GMC Ratio|0.73|||<|0.001|2-Sided|95.0|0.64|0.85||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669429|NCT01392378|3072226|Superiority or Other||GMC Ratio|0.85|||<|0.104|2-Sided|95.0|0.74|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669430|NCT01392378|3072226|Superiority or Other||GMC Ratio|0.84|||<|0.136|2-Sided|95.0|0.73|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669431|NCT01392378|3072226|Superiority or Other||GMC Ratio|0.96|||<|0.813|2-Sided|95.0|0.83|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669432|NCT01392378|3072226|Superiority or Other||GMC Ratio|0.88|||<|0.19|2-Sided|95.0|0.76|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669433|NCT01392378|3072226|Superiority or Other||GMC Ratio|0.9|||<|0.357|2-Sided|95.0|0.78|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669434|NCT01392378|3072226|Superiority or Other||GMC Ratio|0.97|||<|0.837|2-Sided|95.0|0.84|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669435|NCT01392378|3072226|Superiority or Other||GMC Ratio|0.91|||<|0.712|2-Sided|95.0|0.79|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669436|NCT01392378|3072227|Superiority or Other||GMC Ratio|0.89||||0.545|2-Sided|95.0|0.68|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669437|NCT01392378|3072227|Superiority or Other||GMC Ratio|0.85||||0.461|2-Sided|95.0|0.65|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669791|NCT01389856|3072570|Superiority or Other|||||||0.3863|||||||Non-parametric ANCOVA||||
1669438|NCT01392378|3072227|Superiority or Other||GMC Ratio|1.03||||0.845|2-Sided|95.0|0.79|1.34||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669439|NCT01392378|3072227|Superiority or Other||GMC Ratio|0.93||||0.813|2-Sided|95.0|0.71|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669440|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.7||||0.267|2-Sided|95.0|0.42|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669441|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.7||||0.2742|2-Sided|95.0|0.43|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669442|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.1||||0.7907|2-Sided|95.0|0.68|1.69||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669443|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.8||||0.5823|2-Sided|95.0|0.48|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669444|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.7||||0.267|2-Sided|95.0|0.54|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669445|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.8||||0.3299|2-Sided|95.0|0.6|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669446|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.9||||0.7636|2-Sided|95.0|0.65|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669447|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.8||||0.5823|2-Sided|95.0|0.61|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669448|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.9||||0.8826|2-Sided|95.0|0.59|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669449|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.8||||0.4644|2-Sided|95.0|0.56|1.25||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669450|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.1||||0.7636|2-Sided|95.0|0.78|1.7||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669451|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.7||||0.5823|2-Sided|95.0|0.5|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669452|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.3||||0.5155|2-Sided|95.0|0.83|2.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669453|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.7||||0.2824|2-Sided|95.0|0.45|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669454|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.3||||0.7636|2-Sided|95.0|0.81|2.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669455|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.1||||0.8454|2-Sided|95.0|0.72|1.78||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669608|NCT01392300|3072253|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.08||0.175|2-Sided|95.0|-0.3|0.1|||ANCOVA||||
1669456|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.7||||0.267|2-Sided|95.0|0.53|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669457|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.6||||0.0422|2-Sided|95.0|0.48|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669458|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.9||||0.7636|2-Sided|95.0|0.65|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669459|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.8||||0.5823|2-Sided|95.0|0.62|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669460|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.7||||0.267|2-Sided|95.0|0.42|1.02||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669461|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.7||||0.2407|2-Sided|95.0|0.43|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669462|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.9||||0.7907|2-Sided|95.0|0.58|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669463|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.1||||0.9414|2-Sided|95.0|0.67|1.65||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669464|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.9||||0.8826|2-Sided|95.0|0.49|1.58||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669465|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.9||||0.738|2-Sided|95.0|0.5|1.63||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669466|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.2||||0.7636|2-Sided|95.0|0.68|2.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669467|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.9||||0.9414|2-Sided|95.0|0.51|1.71||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669468|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.1||||0.8826|2-Sided|95.0|0.61|1.83||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669469|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.6||||0.2407|2-Sided|95.0|0.34|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669470|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.8||||0.7636|2-Sided|95.0|0.46|1.35||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669471|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.2||||0.7433|2-Sided|95.0|0.7|2.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669472|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.9||||0.8826|2-Sided|95.0|0.62|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669473|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.8||||0.3929|2-Sided|95.0|0.53|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669792|NCT01389856|3072571|Superiority or Other|||||||0.0824|||||||Non-parametric ANCOVA||||
1669474|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.8||||0.7636|2-Sided|95.0|0.52|1.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669475|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.0||||0.9925|2-Sided|95.0|0.65|1.54||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669476|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.0||||0.8826|2-Sided|95.0|0.6|1.82||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669477|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.7||||0.29|2-Sided|95.0|0.39|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669478|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.7||||0.7636|2-Sided|95.0|0.38|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669479|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.5||||0.0961|2-Sided|95.0|0.26|0.81||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669480|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.2||||0.8826|2-Sided|95.0|0.43|3.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669481|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.4||||0.2407|2-Sided|95.0|0.14|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669482|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.7||||0.7636|2-Sided|95.0|0.27|1.8||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669483|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.5||||0.5823|2-Sided|95.0|0.18|1.4||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669484|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.9||||0.8826|2-Sided|95.0|0.44|1.77||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669485|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.6||||0.29|2-Sided|95.0|0.32|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669486|NCT01392378|3072228|Superiority or Other||GMT Ratio|0.9||||0.7907|2-Sided|95.0|0.45|1.71||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669487|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.1||||0.9414|2-Sided|95.0|0.52|2.17||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669488|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.3||||0.5037|2-Sided|95.0|0.89|1.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669489|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.1||||0.4765|2-Sided|95.0|0.81|1.6||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669490|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.0||||0.7907|2-Sided|95.0|0.75|1.45||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669491|NCT01392378|3072228|Superiority or Other||GMT Ratio|1.2||||0.7148|2-Sided|95.0|0.82|1.66||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669742|NCT01390428|3072486|Superiority or Other||GMR|9.34|||||2-Sided|90.0|4.98|17.51|||||Severe HI/Healthy Matched to Severe HI||
1669492|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.95||||0.9765|2-Sided|95.0|0.81|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669493|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.95||||0.6922|2-Sided|95.0|0.8|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669494|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.04||||0.7918|2-Sided|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669495|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.92||||0.6304|2-Sided|95.0|0.78|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669496|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.0||||0.9872|2-Sided|95.0|0.88|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669497|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.89||||0.2514|2-Sided|95.0|0.79|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669498|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.98||||0.7918|2-Sided|95.0|0.86|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669499|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.95||||0.6572|2-Sided|95.0|0.84|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669500|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.97||||0.9765|2-Sided|95.0|0.82|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669501|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.95||||0.6922|2-Sided|95.0|0.81|1.13||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669502|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.04||||0.7918|2-Sided|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669503|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.93||||0.6304|2-Sided|95.0|0.78|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669504|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.92||||0.9765|2-Sided|95.0|0.79|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669505|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.85||||0.2514|2-Sided|95.0|0.73|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669506|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.97||||0.7918|2-Sided|95.0|0.84|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669507|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.82||||0.1424|2-Sided|95.0|0.71|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669508|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.9||||0.9765|2-Sided|95.0|0.76|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669509|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.85||||0.2514|2-Sided|95.0|0.72|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669510|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.99||||0.9279|2-Sided|95.0|0.84|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669511|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.84||||0.2582|2-Sided|95.0|0.71|1.01||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669512|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.03||||0.9765|2-Sided|95.0|0.88|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669513|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.88||||0.2514|2-Sided|95.0|0.75|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669514|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.06||||0.7918|2-Sided|95.0|0.91|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669515|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.92||||0.6304|2-Sided|95.0|0.79|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669516|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.04||||0.9765|2-Sided|95.0|0.86|1.26||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669517|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.86||||0.2514|2-Sided|95.0|0.71|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669518|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.08||||0.7918|2-Sided|95.0|0.89|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669519|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.85||||0.3609|2-Sided|95.0|0.7|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669520|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.01||||0.9872|2-Sided|95.0|0.83|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669521|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.95||||0.6922|2-Sided|95.0|0.78|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669522|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.13||||0.7918|2-Sided|95.0|0.93|1.38||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669523|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.06||||0.6915|2-Sided|95.0|0.86|1.3||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669524|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.03||||0.9765|2-Sided|95.0|0.88|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669525|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.86||||0.2514|2-Sided|95.0|0.74|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669526|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.06||||0.7918|2-Sided|95.0|0.91|1.23||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669527|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.85||||0.2582|2-Sided|95.0|0.73|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669528|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.0||||0.9872|2-Sided|95.0|0.84|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669529|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.87||||0.2514|2-Sided|95.0|0.73|1.04||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669530|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.92||||0.7918|2-Sided|95.0|0.78|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669531|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.89||||0.5167|2-Sided|95.0|0.74|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669532|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.98||||0.9765|2-Sided|95.0|0.85|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669533|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.0||||0.943|2-Sided|95.0|0.88|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669534|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.03||||0.7918|2-Sided|95.0|0.9|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669535|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.99||||0.935|2-Sided|95.0|0.87|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669536|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.03||||0.9765|2-Sided|95.0|0.85|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669537|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.9||||0.4389|2-Sided|95.0|0.75|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669538|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.13||||0.7918|2-Sided|95.0|0.94|1.36||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669539|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.95||||0.6915|2-Sided|95.0|0.78|1.15||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669540|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.11||||0.9765|2-Sided|95.0|0.93|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669541|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.96||||0.6922|2-Sided|95.0|0.8|1.14||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669542|NCT01392378|3072230|Superiority or Other||GMC Ratio|1.11||||0.7918|2-Sided|95.0|0.93|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669543|NCT01392378|3072230|Superiority or Other||GMC Ratio|0.99||||0.935|2-Sided|95.0|0.82|1.19||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669544|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.04||||0.8414|2-Sided|95.0|0.89|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669545|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.84||||0.0387|2-Sided|95.0|0.72|0.99||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669546|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.13||||0.3121|2-Sided|95.0|0.96|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669547|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.9||||0.2412|2-Sided|95.0|0.76|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669548|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.06||||0.8414|2-Sided|95.0|0.93|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669549|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.85||||0.0275|2-Sided|95.0|0.75|0.98||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669550|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.03||||0.6652|2-Sided|95.0|0.91|1.18||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669551|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.9||||0.2412|2-Sided|95.0|0.79|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669552|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.11||||0.8414|2-Sided|95.0|0.92|1.34||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669553|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.77||||0.0135|2-Sided|95.0|0.64|0.93||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669554|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.14||||0.3121|2-Sided|95.0|0.95|1.37||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669555|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.88||||0.2412|2-Sided|95.0|0.73|1.07||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669556|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.11||||0.8414|2-Sided|95.0|0.93|1.31||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669557|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.77||||0.0093|2-Sided|95.0|0.65|0.92||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669558|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.21||||0.2053|2-Sided|95.0|1.02|1.43||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669559|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.98||||0.7828|2-Sided|95.0|0.82|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669560|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.96||||0.8414|2-Sided|95.0|0.82|1.11||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669561|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.65|||<|0.0001|2-Sided|95.0|0.56|0.76||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669562|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.95|||<|0.609|2-Sided|95.0|0.82|1.1||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669563|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.81|||<|0.0732|2-Sided|95.0|0.69|0.94||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669564|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.04|||<|0.8414|2-Sided|95.0|0.88|1.22||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669565|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.82|||<|0.0241|2-Sided|95.0|0.7|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669566|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.2|||<|0.2053|2-Sided|95.0|1.02|1.41||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669567|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.9|||<|0.2412|2-Sided|95.0|0.76|1.06||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669568|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.03|||<|0.8414|2-Sided|95.0|0.84|1.27||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669569|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.7|||<|0.0038|2-Sided|95.0|0.57|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669570|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.15|||<|0.3121|2-Sided|95.0|0.93|1.41||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669571|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.81|||<|0.1749|2-Sided|95.0|0.66|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669572|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.03|||<|0.8414|2-Sided|95.0|0.87|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669573|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.8|||<|0.0135|2-Sided|95.0|0.68|0.94||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669574|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.15|||<|0.3121|2-Sided|95.0|0.99|1.35||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669575|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.9|||<|0.2412|2-Sided|95.0|0.76|1.05||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669576|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.14|||<|0.8414|2-Sided|95.0|0.97|1.33||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669577|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.82|||<|0.0191|2-Sided|95.0|0.7|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669578|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.13|||<|0.3121|2-Sided|95.0|0.96|1.32||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669579|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.95|||<|0.6193|2-Sided|95.0|0.81|1.12||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669580|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.98|||<|0.8414|2-Sided|95.0|0.79|1.21||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669581|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.88|||<|0.2472|2-Sided|95.0|0.72|1.09||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669582|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.88|||<|0.3279|2-Sided|95.0|0.71|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669583|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.83|||<|0.2158|2-Sided|95.0|0.67|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669584|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.07|||<|0.8414|2-Sided|95.0|0.93|1.24||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669585|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.89|||<|0.1351|2-Sided|95.0|0.78|1.03||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669586|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.11|||<|0.3121|2-Sided|95.0|0.96|1.27||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669587|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.87|||<|0.1749|2-Sided|95.0|0.75|1.0||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669588|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.1|||<|0.8414|2-Sided|95.0|0.86|1.42||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669589|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.69|||<|0.0093|2-Sided|95.0|0.53|0.88||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669590|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.13|||<|0.4548|2-Sided|95.0|0.88|1.44||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669591|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.83|||<|0.2412|2-Sided|95.0|0.64|1.08||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669592|NCT01392378|3072232|Superiority or Other||GMC Ratio|1.02|||<|0.8414|2-Sided|95.0|0.87|1.2||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669593|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.73|||<|0.0012|2-Sided|95.0|0.62|0.86||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669594|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.99|||<|0.8546|2-Sided|95.0|0.84|1.16||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669595|NCT01392378|3072232|Superiority or Other||GMC Ratio|0.81|||<|0.0856|2-Sided|95.0|0.69|0.96||P-values were adjusted using false discovery rate procedure.|General Linear Model|||Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.|
1669596|NCT01392326|3072242|Superiority or Other||Odds Ratio (OR)|5.39|||<|0.0001|2-Sided|95.0|3.37|8.62|||Regression, Logistic||||
1669597|NCT01392326|3072242|Superiority or Other||Odds Ratio (OR)|5.53|||<|0.0001|2-Sided|95.0|3.46|8.85|||Regression, Logistic||||
1669598|NCT01392300|3072243|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.1||0.844|2-Sided|95.0|-0.2|0.2|||ANCOVA||||
1669599|NCT01392300|3072244|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.09||0.884|2-Sided|95.0|-0.2|0.2|||ANCOVA||||
1669600|NCT01392300|3072245|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.09||0.429|2-Sided|95.0|-0.2|0.1|||ANCOVA||||
1669601|NCT01392300|3072246|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.07||0.22|2-Sided|95.0|-0.2|0.1|||ANCOVA||||
1669602|NCT01392300|3072247|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.08||0.014|2-Sided|95.0|-0.4|0.0|||ANCOVA||||
1669603|NCT01392300|3072248|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.08||0.016|2-Sided|95.0|-0.4|0.0|||ANCOVA||||
1669604|NCT01392300|3072249|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.07||0.105|2-Sided|95.0|-0.3|0.0|||ANCOVA||||
1669793|NCT01389856|3072572|Superiority or Other|||||||0.1015|||||||Non-parametric ANCOVA||||
1669609|NCT01392300|3072254|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.07|<|0.001|2-Sided|95.0|-0.4|-0.1|||ANCOVA||||
1669610|NCT01392300|3072255|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.08||0.416|2-Sided|95.0|-0.2|0.1|||ANCOVA||||
1669611|NCT01392300|3072256|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.08||0.076|2-Sided|95.0|-0.3|0.0|||ANCOVA||||
1669612|NCT01392300|3072257|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.08||0.006|2-Sided|95.0|-0.4|-0.1|||ANCOVA||||
1669613|NCT01392300|3072258|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.08||0.062|2-Sided|95.0|-0.3|0.0|||ANCOVA||||
1669614|NCT01392300|3072259|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.09||0.008|2-Sided|95.0|-0.4|-0.1|||ANCOVA||||
1669615|NCT01392300|3072260|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.08|<|0.001|2-Sided|95.0|-0.5|-0.2|||ANCOVA||||
1669616|NCT01392300|3072261|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.08||0.714|2-Sided|95.0|-0.2|0.1|||ANCOVA||||
1669617|NCT01392300|3072262|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.09||0.131|2-Sided|95.0|-0.3|0.0|||ANCOVA||||
1669618|NCT01392300|3072263|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.09||0.013|2-Sided|95.0|-0.4|0.0|||ANCOVA||||
1669619|NCT01392300|3072264|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.08||0.137|2-Sided|95.0|-0.3|0.0|||ANCOVA||||
1669620|NCT01392300|3072265|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.09||0.019|2-Sided|95.0|-0.4|0.0|||ANCOVA||||
1669621|NCT01392300|3072266|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.09|<|0.001|2-Sided|95.0|-0.5|-0.2|||ANCOVA||||
1669622|NCT01392300|3072267|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.08||0.029|2-Sided|95.0|-0.3|0.0|||ANCOVA||||
1669623|NCT01392300|3072268|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.09|<|0.001|2-Sided|95.0|-0.5|-0.1|||ANCOVA||||
1669624|NCT01392300|3072269|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.08|<|0.001|2-Sided|95.0|-0.6|-0.2|||ANCOVA||||
1669625|NCT01392300|3072270|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.08||0.032|2-Sided|95.0|-0.3|0.0|||ANCOVA||||
1669626|NCT01392300|3072271|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.09||0.011|2-Sided|95.0|-0.4|-0.1|||ANCOVA||||
1669627|NCT01392300|3072272|Superiority or Other||Mean Difference (Final Values)|-0.4|||<|0.001|2-Sided|95.0|-0.5|-0.2|||ANCOVA||||
1669628|NCT01392300|3072273|Superiority or Other||Odds Ratio (OR)|2.26||||0.018|2-Sided|95.0|1.15|4.41|||Regression, Logistic||||
1669629|NCT01392300|3072274|Superiority or Other||Odds Ratio (OR)|2.41||||0.007|2-Sided|95.0|1.28|4.56|||Regression, Logistic||||
1669630|NCT01392300|3072275|Superiority or Other||Odds Ratio (OR)|3.56|||<|0.001|2-Sided|95.0|1.83|6.91|||Regression, Logistic||||
1669631|NCT01392300|3072276|Superiority or Other||Odds Ratio (OR)|1.04||||0.92|2-Sided|95.0|0.49|2.18|||Regression, Logistic||||
1669632|NCT01392300|3072277|Superiority or Other||Odds Ratio (OR)|1.61||||0.169|2-Sided|95.0|0.82|3.16|||Regression, Logistic||||
1669633|NCT01392300|3072278|Superiority or Other||Odds Ratio (OR)|2.05||||0.034|2-Sided|95.0|1.05|4.0|||Regression, Logistic||||
1669634|NCT01392300|3072279|Superiority or Other||Odds Ratio (OR)|1.87||||0.069|2-Sided|95.0|0.95|3.69|||Regression, Logistic||||
1669635|NCT01392300|3072280|Superiority or Other||Odds Ratio (OR)|2.46||||0.002|2-Sided|95.0|1.37|4.41|||Regression, Logistic||||
1669636|NCT01392300|3072281|Superiority or Other||Odds Ratio (OR)|2.95|||<|0.001|2-Sided|95.0|1.67|5.23|||Regression, Logistic||||
1669637|NCT01392300|3072282|Superiority or Other||Odds Ratio (OR)|1.7||||0.102|2-Sided|95.0|0.9|3.22|||Regression, Logistic||||
1669638|NCT01392300|3072283|Superiority or Other||Odds Ratio (OR)|2.5||||0.002|2-Sided|95.0|1.4|4.46|||Regression, Logistic||||
1669639|NCT01392300|3072284|Superiority or Other||Odds Ratio (OR)|3.72|||<|0.001|2-Sided|95.0|2.06|6.72|||Regression, Logistic||||
1669640|NCT01392300|3072285|Superiority or Other||Odds Ratio (OR)|2.58||||0.006|2-Sided|95.0|1.32|5.05|||Regression, Logistic||||
1669641|NCT01392300|3072286|Superiority or Other||Odds Ratio (OR)|1.92||||0.021|2-Sided|95.0|1.1|3.34|||Regression, Logistic||||
1669642|NCT01392300|3072287|Superiority or Other||Odds Ratio (OR)|3.13|||<|0.001|2-Sided|95.0|1.76|5.57|||Regression, Logistic||||
1669643|NCT01392300|3072288|Superiority or Other||Odds Ratio (OR)|2.48||||0.004|2-Sided|95.0|1.33|4.61|||Regression, Logistic||||
1669644|NCT01392300|3072289|Superiority or Other||Odds Ratio (OR)|2.69|||<|0.001|2-Sided|95.0|1.56|4.63|||Regression, Logistic||||
1669645|NCT01392300|3072290|Superiority or Other||Odds Ratio (OR)|4.28|||<|0.001|2-Sided|95.0|2.43|7.52|||Regression, Logistic||||
1669646|NCT01392300|3072291|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.11||0.003|2-Sided|95.0|0.1|0.5|||ANCOVA||||
1669647|NCT01392300|3072292|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.7|-0.3|||ANCOVA||||
1669648|NCT01391793|3072336|Superiority|||||||0.07|||||||Generalized estimating equations|The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (<24 months, >=24 months).||Null hypothesis: There is no difference between the two treatment arms regarding the mean proportion of children with renal scarring at the outcome DMSA scan taken across the 3 radiologists.|
1669649|NCT01391793|3072337|Superiority|||||||0.25|||||||Test of equality - 2 Poisson parameters|The method used is a conditional test.||Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with severe renal scarring at the outcome DMSA renal scan.|
1669743|NCT01390428|3072486|Superiority or Other||GMR|3.59|||||2-Sided|90.0|1.81|7.11|||||Moderate HI/Healthy Matched to Moderate HI||
1669650|NCT01391793|3072338|Superiority|||||||0.16|||||||Regression, Logistic|The p-value is adjusted for the stratification variable, duration of fever, and for age at baseline (<24 months, >=24 months).||Null hypothesis: There is no difference between the two treatment arms regarding the proportion of children with renal scarring at the outcome DMSA renal scan.|
1669651|NCT01391559|3072347|Superiority or Other||Mean Difference (Final Values)|32.0||||0.17||95.0|||||t-test, 2 sided||||
1669652|NCT01391546|3072354|Superiority or Other||GMFR|2.7|||||2-Sided|95.0|2.4|3.0|||||GMFR = GMT Post-vaccination/GMT Pre-vaccination|Acceptability was demonstrated if the lower bound of the two-sided 95% CI was >1.4|
1669653|NCT01391546|3072355|Non-Inferiority or Equivalence|Non-inferiority was achieved if the lower bound of the 2-sided 95% confidence interval (CI) for the GMT ratio was greater than 2/3|GMT Ratio|1.05|||<|0.001|2-Sided|95.0|0.93|1.18|||longitudinal regression model|Model adjusted for pre-vaccination titres and age at vaccination in years|GMT ratio = GMT IM route divided by GMT SC route||
1669654|NCT01391468|3072366|Superiority or Other|||||||0.0099||||||Only the probiotics group arrived at the reported p-value after 6 months|Wilcoxon (Mann-Whitney)||||
1669655|NCT01391468|3072367|Superiority or Other|||||||0.0042||||||Only the probiotics group arrived at the reported p-value after 6 months|Wilcoxon (Mann-Whitney)||||
1669656|NCT01391468|3072368|Superiority or Other|||||||0.744|||||||Wilcoxon (Mann-Whitney)||||
1669657|NCT01391468|3072369|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1669658|NCT01391130|3072394|Superiority||Hazard Ratio (HR)|1.2149||||0.4318|2-Sided|95.0|0.7462|1.9779|||Log Rank||||
1669659|NCT01391013|3072396|Superiority or Other|||||||0.04|||||||Nonparametric Wilcoxon rank sum test||||
1669660|NCT01391013|3072397|Superiority or Other|||||||0.03|||||||Nonparametric Wilcoxon rank sum test||||
1669661|NCT01391013|3072398|Superiority or Other|||||||0.18|||||||Nonparametric Wilcoxon rank sum test||||
1669662|NCT01391013|3072399|Superiority or Other|||||||0.11|||||||Nonparametric Wilcoxon rank sum test||||
1669663|NCT01391013|3072400|Superiority or Other|||||||0.56|||||||Nonparametric Wilcoxon rank sum test||||
1669664|NCT01391013|3072401|Superiority or Other|||||||0.76|||||||Nonparametric Wilcoxon rank sum test||||
1669665|NCT01391013|3072402|Superiority or Other|||||||0.66|||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.|||
1669666|NCT01391013|3072403|Superiority or Other|||||||0.83|||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.|||
1669667|NCT01391013|3072404|Superiority or Other|||||||0.71|||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.|||
1669668|NCT01391013|3072405|Superiority or Other|||||||0.12|||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.|||
1669669|NCT01391013|3072406|Superiority or Other|||||||0.02|||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.|||
1669670|NCT01391013|3072407|Superiority or Other|||||||0.66|||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.|||
1669671|NCT01391013|3072408|Superiority or Other|||||||0.37|||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.|||
1669672|NCT01391013|3072409|Superiority or Other|||||||0.31|||||||Nonparametric Wilcoxon rank sum test|This statistical analysis applies to 'Week 48'.|||
1669673|NCT01391013|3072410|Superiority or Other|||||||0.88|||||||Nonparametric Wilcoxon rank sum test||||
1669674|NCT01391013|3072411|Superiority or Other|||||||0.08|||||||Nonparametric Wilcoxon rank sum test||||
1669675|NCT01390948|3072428|Superiority or Other (legacy)||Hazard Ratio (HR)|1.44||||0.1292|2-Sided|95.0|0.9|2.3|||Log Rank||||
1669676|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|7673.0|||<|0.0001|2-Sided|95.0|4571.0|10989.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669677|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|58.0|||<|0.0001|2-Sided|95.0|28.0|93.0||Adjusted Cost Differences in Other Healthcare Services, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669678|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|65.0|||<|0.1061|2-Sided|95.0|-22.0|145.0||Adjusted Cost Differences in Neurologist Visits, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669679|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|236.0|||<|0.01|2-Sided|95.0|70.0|403.0||Adjusted Cost Differences in Outpatient Services, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669680|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|112.0|||<|0.0001|2-Sided|95.0|70.0|166.0||Adjusted Cost Differences in Emergency Department Visits, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669681|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|4984.0|||<|0.0001|2-Sided|95.0|3168.0|7335.0||Adjusted Cost Differences in Hospitalizations, Epilepsy-Related|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669682|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|328.0|||<|0.01|2-Sided|95.0|90.0|588.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669683|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|97.0|||<|0.2563|2-Sided|95.0|-77.0|302.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669744|NCT01390428|3072486|Superiority or Other||GMR|1.92|||||2-Sided|90.0|1.4|2.63|||||Mild HI/Healthy Matched to Mild HI||
1669882|NCT01387815|3072809|Other|||||||0.143|||||||Chi-squared||||
1669684|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|-40.0|||<|0.967|2-Sided|95.0|-991.0|944.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669685|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|268.0|||<|0.002|2-Sided|95.0|81.0|425.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669686|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|6040.0|||<|0.0001|2-Sided|95.0|3442.0|8795.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669687|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|658.0|||<|0.0001|2-Sided|95.0|217.0|1131.0||Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669688|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|420.0|||<|0.0001|2-Sided|95.0|210.0|630.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669689|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|14582.0|||<|0.0001|2-Sided|95.0|12019.0|17097.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669690|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|83.0|||<|0.0001|2-Sided|95.0|58.0|113.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669691|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|158.0|||<|0.0001|2-Sided|95.0|97.0|231.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669692|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|516.0|||<|0.0001|2-Sided|95.0|401.0|645.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669693|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|150.0|||<|0.0001|2-Sided|95.0|112.0|199.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669694|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|6483.0|||<|0.0001|2-Sided|95.0|5329.0|7927.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669695|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|502.0|||<|0.0001|2-Sided|95.0|234.0|768.0||Adjusted Cost Differences in Other Healthcare Services|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669696|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|357.0|||<|0.0001|2-Sided|95.0|225.0|525.0||Adjusted Cost Differences in Neurologists Visits|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669697|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|2427.0|||<|0.0001|2-Sided|95.0|1587.0|3290.0||Adjusted Cost Differences in Outpatient Services|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669698|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|459.0|||<|0.0001|2-Sided|95.0|326.0|622.0||Adjusted Cost Differences in Emergency Department Visits|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669699|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|9128.0|||<|0.0001|2-Sided|95.0|7346.0|11125.0||Adjusted Cost Differences in Hospitalizations|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669700|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|1047.0|||<|0.0001|2-Sided|95.0|564.0|1486.0||Adjusted Cost Differences in Prescription Drug Costs, Non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669701|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|1019.0|||<|0.0001|2-Sided|95.0|836.0|1191.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669702|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|5437.0|||<|0.0001|2-Sided|95.0|3672.0|7142.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669745|NCT01390428|3072488|Superiority or Other||GMR|2.99|||||2-Sided|90.0|1.31|6.82|||||Moderate HI/Healthy Matched to Moderate HI||
1669746|NCT01390428|3072488|Superiority or Other||GMR|1.86|||||2-Sided|90.0|1.54|2.24|||||Mild HI/Healthy Matched to Mild HI||
1669703|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|277.0|||<|0.0581|2-Sided|95.0|-19.0|581.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669704|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|23.0|||<|0.0001|2-Sided|95.0|15.0|33.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669705|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|211.0|||<|0.0001|2-Sided|95.0|179.0|245.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669706|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|63.0|||<|0.0001|2-Sided|95.0|52.0|74.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669707|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|2306.0|||<|0.0001|2-Sided|95.0|2016.0|2603.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669708|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|235.0|||<|0.7628|2-Sided|95.0|-1367.0|1798.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669709|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|29.0|||<|0.0001|2-Sided|95.0|18.0|42.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669710|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|628.0|||<|0.0001|2-Sided|95.0|409.0|819.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669711|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|164.0|||<|0.0001|2-Sided|95.0|138.0|190.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669712|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|3248.0|||<|0.0001|2-Sided|95.0|2790.0|3714.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669713|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|841.0|||<|0.0001|2-Sided|95.0|556.0|1078.0||Adjusted Cost Differences in Prescription Drug Costs, non-AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669714|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|322.0|||<|0.0001|2-Sided|95.0|245.0|398.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Covariates were gender, age, region, comorbidities, AEDs and non-AEDs known to increase seizure risk and baseline costs.|||
1669715|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|12258.0|||<|0.0001|2-Sided|95.0|10482.0|14083.0||Adjusted Cost Differences in Total Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669716|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|892.0|||<|0.0001|2-Sided|95.0|584.0|1192.0||Adjusted Cost Differences in Other Epilepsy-Related Healthcare Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669717|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|47.0|||<|0.0001|2-Sided|95.0|40.0|56.0||Adjusted Cost Differences in Epilepsy-Related Neurologist Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669718|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|384.0|||<|0.0001|2-Sided|95.0|358.0|413.0||Adjusted Cost Differences in Epilepsy-Related Outpatient Services|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669719|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|105.0|||<|0.0001|2-Sided|95.0|97.0|114.0||Adjusted Cost Differences in Epilepsy-Related Emergency Department Visits|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669747|NCT01390428|3072490|Superiority or Other||GMR|13.01|||||2-Sided|90.0|6.0|28.21|||||Severe HI/Healthy Matched to Severe HI|Day 10|
1669748|NCT01390428|3072490|Superiority or Other||GMR|15.18|||||2-Sided|90.0|6.02|38.25|||||Severe HI/Healthy Matched to Severe HI|Day 1|
1669720|NCT01390909|3072429|Superiority or Other||Mean Difference (Final Values)|4041.0|||<|0.0001|2-Sided|95.0|3776.0|4305.0||Adjusted Cost Differences in Epilepsy-Related Hospitalizations|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669721|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|2555.0|||<|0.008|2-Sided|95.0|834.0|4281.0||Adjusted Cost Differences in Other Healthcare Services, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669722|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|60.0|||<|0.0001|2-Sided|95.0|48.0|72.0||Adjusted Cost Differences in Neurologist Visits, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669723|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|1021.0|||<|0.0001|2-Sided|95.0|819.0|1211.0||Adjusted Cost Differences in Outpatient Services, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669724|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|273.0|||<|0.0001|2-Sided|95.0|251.0|295.0||Adjusted Cost Differences in Emergency Department Visits, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669725|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|5681.0|||<|0.0001|2-Sided|95.0|5257.0|6077.0||Adjusted Cost Differences in Hospitalizations, All Medical Costs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669726|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|1879.0|||<|0.0001|2-Sided|95.0|1636.0|2112.0||Adjusted Cost Differences in Prescription Drug Costs, nonAEDs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669727|NCT01390909|3072429|Superiority or Other||Median Difference (Final Values)|849.0|||<|0.0001|2-Sided|95.0|786.0|921.0||Adjusted Cost Differences in Prescription Drug Costs, AEDs|Ordinary Least Squares Regression|Ordinary least squares regression was used to adjust differences. Covariates were gender, age, region, comorbidities, baseline treatment, and costs.|Confidence intervals were calculated using a nonparametric bootstrap with 999 replications.||
1669728|NCT01390844|3072439|Superiority or Other||Difference in Percentage|36.13||||0.004|2-Sided|95.0|12.12|55.01|||Mittienen and Nurminen|||Between-Group Comparison|
1669729|NCT01390844|3072440|Superiority or Other||Difference in Percentage|29.08|||<|0.001|2-Sided|95.0|15.26|42.22|||Miettinen and Nurminen|||Between-Group Comparison|
1669730|NCT01390844|3072441|Superiority or Other||Difference in Percentage|33.18||||0.0086|2-Sided|95.0|8.96|51.83|||Miettinen and Numinen|||Between-Group Comparison|
1669731|NCT01390844|3072442|Superiority or Other||Difference in Percentage|35.05|||<|0.0001|2-Sided|95.0|20.51|47.72|||Miettinen and Numinen|||Between-Group Comparison|
1669732|NCT01390844|3072443|Superiority or Other||Difference in Percentage|33.83||||0.0063|2-Sided|95.0|10.15|52.18|||Miettinen and Numinen|||Between-Group Comparison|
1669733|NCT01390844|3072444|Superiority or Other||Difference in Percentage|34.63|||<|0.0001|2-Sided|95.0|20.24|47.18|||Miettinen and Numinen|||Between-Group Comparison|
1669734|NCT01390441|3072476|Non-Inferiority or Equivalence||Mean Difference (Final Values)|0.4|||||2-Sided|95.0|-0.4|1.2||||||Estimated difference vs MabThera® at 12 weeks.|
1669735|NCT01390441|3072476|Non-Inferiority or Equivalence||Mean Difference (Final Values)|-0.2|||||2-Sided|95.0|-0.9|0.5||||||Estimated difference vs MabThera® at 6 weeks.|
1669736|NCT01390441|3072480|Non-Inferiority or Equivalence|PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.|Geometric mean ratio|0.98|||||2-Sided|90.0|0.87|1.1||||||Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.|
1669737|NCT01390441|3072482|Superiority or Other||Percent differnce|12.0|||||2-Sided|95.0|-15.6|38.9||||||The difference in percent AE incidence was determined for the treatment comparison (Part B: MabThera® 1000 mg - Part B: Rituxan® 1000 mg) when >=4 participants in an arm experienced an event.|
1669738|NCT01390441|3072482|Superiority or Other||Percent difference|-5.6|||||2-Sided|95.0|-34.9|24.6||||||The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: Rituxan® 1000 mg) when >=4 participants in an arm experienced an event.|
1669739|NCT01390441|3072482|Superiority or Other||Percent difference|-17.5|||||2-Sided|95.0|-44.4|10.9||||||The difference in percent AE incidence was determined for the treatment comparison (Part B: MK-8808 1000 mg - Part B: MabThera 1000 mg) when >=4 participants in an arm experienced an event.|
1669740|NCT01390441|3072482|Superiority or Other||Percent difference|-17.2|||||2-Sided|95.0|-38.6|3.6||||||The difference in percent AE incidence was determined for the treatment comparison (Part A: MK-8808 500 mg/m^2 - Part A: MabThera 500 mg/m^2) when >=4 participants in an arm experienced an event.|
1669741|NCT01390441|3072484|Non-Inferiority or Equivalence|PK bioequivalence was assumed if the 90% confidence interval of the geometric mean ratio for the comparison fell within the range 0.80-1.25.|Geometric mean ratio|1.0|||||2-Sided|90.0|0.87|1.16||||||Back-transformed least squares mean and confidence interval from fixed effects model performed on natural log-transformed values containing treatment as a fixed effect and gender as a covariate.|
1669883|NCT01387815|3072813|Other|||||||0.252|||||||t-test, 2 sided||||
1669749|NCT01390428|3072490|Superiority or Other||GMR|5.98|||||2-Sided|90.0|2.84|12.57|||||Moderate HI/Healthy Matched to Moderate HI|Day 10|
1669750|NCT01390428|3072490|Superiority or Other||GMR|7.64|||||2-Sided|90.0|2.74|21.27|||||Moderate HI/Healthy Matched to Moderate HI|Day 1|
1669751|NCT01390428|3072490|Superiority or Other||GMR|1.37|||||2-Sided|90.0|0.83|2.27|||||Mild HI/Healthy Matched to Mild HI|Day 10|
1669752|NCT01390428|3072490|Superiority or Other||GMR|0.84|||||2-Sided|90.0|0.35|2.01|||||Mild HI/Healthy Matched to Mild HI|Day 1|
1669753|NCT01390428|3072491|Superiority or Other||GMR|11.68|||||2-Sided|90.0|6.1|22.35|||||Severe HI/Healthy Matched to Severe HI|Day 10|
1669754|NCT01390428|3072491|Superiority or Other||GMR|19.83|||||2-Sided|90.0|8.11|48.51|||||Severe HI/Healthy Matched to Severe HI|Day 1|
1669755|NCT01390428|3072491|Superiority or Other||GMR|4.82|||||2-Sided|90.0|2.6|8.93|||||Moderate HI/Healthy Matched to Moderate HI|Day 10|
1669756|NCT01390428|3072491|Superiority or Other||GMR|5.03|||||2-Sided|90.0|2.19|11.56|||||Moderate HI/Healthy Matched to Moderate HI|Day 1|
1669757|NCT01390428|3072491|Superiority or Other||GMR|1.66|||||2-Sided|90.0|1.05|2.61|||||Mild HI/Healthy Matched to Mild HI|Day 10|
1669758|NCT01390428|3072491|Superiority or Other||Geometric Least Squares Mean Ratio (GMR)|1.21|||||2-Sided|90.0|0.73|2.01|||||Mild Hepatic Impairment (HI)/Healthy Matched to Mild HI|Day 1|
1669759|NCT01390415|3072492|Superiority or Other|||||||0.0566|||||||t-test, 2 sided|||Between-group comparison of Change from Baseline at Month 6|
1669760|NCT01390415|3072493|Superiority or Other|||||||0.0374|||||||t-test, 2 sided|||Between-group comparison of Change from Baseline at Month 6|
1669761|NCT01390272|3072499|Non-Inferiority or Equivalence||Odds Ratio (OR)|1.2||||0.3|2-Sided|95.0|0.8|1.9|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status and blood pressure control.||Comparison at 18 months|
1669762|NCT01390272|3072500|Non-Inferiority or Equivalence||Odds Ratio (OR)|1.4||||0.12|2-Sided|95.0|0.9|2.1|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link.Adjusted for baseline stratification variable of diabetes status and blood pressure control.||Comparison at 12 months|
1669763|NCT01390272|3072501|Non-Inferiority or Equivalence||Odds Ratio (OR)|1.0||||0.95|2-Sided|95.0|0.7|1.5|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variable of diabetes status and diabetes control.|||
1669764|NCT01390272|3072504|Non-Inferiority or Equivalence||Odds Ratio (OR)|1.5||||0.09|2-Sided|95.0|0.9|2.3|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 18 months.|
1669765|NCT01390272|3072505|Non-Inferiority or Equivalence||Odds Ratio (OR)|0.9||||0.53|2-Sided|95.0|0.5|1.4|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 12 months|
1669766|NCT01390272|3072506|Non-Inferiority or Equivalence||Odds Ratio (OR)|1.0||||0.83|2-Sided|95.0|0.7|1.6|||Generalized Estimating Equation|Generalized Estimating Equation with a Logit Link. Adjusted for baseline stratification variables of diabetes status.||Comparison at 6 months|
1669767|NCT01390272|3072508|Non-Inferiority or Equivalence||Mean Difference (Net)|-1.6||||0.43|2-Sided|95.0|-5.6|2.4|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.|||
1669768|NCT01390272|3072509|Non-Inferiority or Equivalence||Mean Difference (Net)|-1.3||||0.5|2-Sided|95.0|-4.9|2.4|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.|||
1669769|NCT01390272|3072510|Non-Inferiority or Equivalence||Mean Difference (Net)|-2.1||||0.26|2-Sided|95.0|-5.9|1.6|||Mixed Models Analysis|Constrained longitudinal model adjusting for baseline stratification variables of diabetes status and blood pressure control.|||
1669770|NCT01390220|3072520|Superiority|||||||0.0124|||||||Log Rank|||Kaplan-Meier estimates.|
1669771|NCT01390220|3072521|Superiority|||||||0.0124|||||||Log Rank||||
1669772|NCT01390220|3072522|Superiority|||||||0.0043|||||||Fisher Exact|2-sided|||
1669773|NCT01390220|3072523|Superiority|||||||0.0109|||||||Fisher Exact|2-sided|||
1669774|NCT01389882|3072538|Superiority or Other||Mean Difference (Final Values)|-0.274|Standard Deviation|2.233||0.6|2-Sided|95.0|-1.35|0.802|||Paired t-test||||
1669775|NCT01389882|3072539|Superiority or Other||Mean Difference (Final Values)|1.053|Standard Deviation|12.081||0.709|2-Sided|95.0|-4.77|6.875|||Paired t-test||||
1669776|NCT01389882|3072540|Superiority or Other||Mean Difference (Final Values)|0.1105|Standard Deviation|7.501||0.949|2-Sided|95.0|-3.505|3.726|||Paired t-test||||
1669777|NCT01389882|3072541|Superiority or Other||Mean Difference (Final Values)|-0.007|Standard Deviation|0.047||0.515|2-Sided|95.0|-0.03|0.016|||Paired t-test||||
1669778|NCT01389882|3072542|Superiority or Other||Mean Difference (Final Values)|0.692|Standard Deviation|2.192||0.314|2-Sided|95.0|-0.364|1.749|||Wilcoxon signed-rank test||||
1669779|NCT01389882|3072543|Superiority or Other||Mean Difference (Final Values)|1.69|Standard Deviation|2.516||0.009|2-Sided|95.0|0.478|2.904|||Paired t-test, 2-sided||||
1669780|NCT01389882|3072544|Superiority or Other||Mean Difference (Final Values)|6.516|Standard Deviation|9.786||0.002|2-Sided|95.0|1.799|11.232|||Wilcoxon signed-rank test||||
1669781|NCT01389882|3072545|Superiority or Other||Mean Difference (Final Values)|-0.149|Standard Deviation|0.355||0.085|2-Sided|95.0|-0.32|0.023|||Paired t-test||||
1669782|NCT01389882|3072546|Superiority or Other||Mean Difference (Final Values)|0.188|Standard Deviation|1.541||0.601|2-Sided|95.0|-0.554|0.931|||Paired t-test||||
1669783|NCT01389882|3072547|Superiority or Other||Mean Difference (Final Values)|0.026|Standard Deviation|0.095||0.257|2-Sided|95.0|-0.02|0.714|||Paired t-test||||
1669784|NCT01389882|3072548|Superiority or Other||Median Difference (Final Values)|-0.232|Standard Deviation|0.841||0.245|2-Sided|95.0|-0.637|0.174|||Paired t-test||||
1669785|NCT01389882|3072549|Superiority or Other||Mean Difference (Final Values)|1.007|Standard Deviation|2.015||0.043|2-Sided|95.0|0.036|1.978|||Paired t-test||||
1669786|NCT01389856|3072565|Superiority or Other|||||||0.14|||||||Non-parametric ANCOVA||||
1669794|NCT01389856|3072573|Superiority or Other|||||||0.0569|||||||Non-parametric ANCOVA||||
1669795|NCT01389856|3072574|Superiority or Other|||||||0.3723|||||||Non-parametric ANCOVA||||
1669796|NCT01389856|3072575|Superiority or Other|||||||0.0789|||||||Non-parametric ANCOVA||||
1669797|NCT01389856|3072576|Superiority or Other|||||||0.1468|||||||Non-parametric ANCOVA||||
1669798|NCT01389856|3072577|Superiority or Other|||||||0.2235|||||||Non-parametric ANCOVA||||
1669799|NCT01389856|3072578|Superiority or Other|||||||1|||||||Fisher Exact||||
1669800|NCT01389856|3072580|Superiority or Other|||||||0.2399|||||||Log Rank||||
1669801|NCT01389856|3072581|Superiority or Other|||||||0.3407|||||||Log Rank||||
1669802|NCT01389856|3072582|Superiority or Other|||||||1|||||||Fisher Exact||||
1669803|NCT01389765|3072584|Superiority or Other||Median Difference (Final Values)|1.0||||0.0031|2-Sided|90.0|0.5|1.5|||Wilcoxon (Mann-Whitney)|Analyzed were the median of paired differences between the 2 treatment states (fed versus fasted) and the 90% confidence interval.|||
1669804|NCT01389765|3072585|Superiority or Other||Ratio of Geometric Least Squares Means|0.96|||||2-Sided|90.0|0.92|1.01|||||||
1669805|NCT01389765|3072586|Superiority or Other||Ratio of Geometric Least Squares Means|1.01|||||2-Sided|90.0|0.97|1.05|||||||
1669806|NCT01389752|3072587|Superiority or Other||Median Difference (Final Values)|-0.55||||0.001|2-Sided|90.0|-1.04|-0.5||The outcome was measured using the median of paired differences between the 2 treatment groups: LY2216684 administered alone (reference) versus LY2216684 co-administered with charcoal (test).|Wilcoxon (Mann-Whitney)||||
1669807|NCT01389752|3072588|Superiority or Other||Ratio of Geometric Least Squares Means|0.9|||||2-Sided|90.0|0.83|0.98|||||||
1669808|NCT01389752|3072589|Superiority or Other||Ratio of Geometric Least Squares Means|0.65|||||2-Sided|90.0|0.61|0.68|||||||
1669809|NCT01389596|3072605|Superiority or Other||Odds Ratio (OR)|1.636||||0.0092|2-Sided|95.0|0.851|3.147|||Regression, Logistic|||P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.|
1669810|NCT01389596|3072605|Superiority or Other||Odds Ratio (OR)|1.036||||0.8024|2-Sided|95.0|0.528|2.03|||Regression, Logistic|||P-values were from a Logistic Regression Model including fixed effects for treatment, weight group, and geographical region.|
1669811|NCT01389596|3072606|Superiority or Other||LS Mean Difference|-0.22|Standard Error of the Mean|0.094||0.0185|2-Sided|95.0|-0.41|-0.04|||ANCOVA|||Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.|
1669812|NCT01389596|3072606|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.092||0.2577|2-Sided|95.0|-0.29|0.08|||ANCOVA|||Linear Model With Log transformed baseline seizure rate as continuous covariate and geographic regions, treatment groups and weight as fixed effects.|
1669813|NCT01389128|3072636|Other|||||||0.68|||||||Chi-squared||||
1669814|NCT01389128|3072639|Other||||||<|0.01|||||||Chi-squared||||
1669815|NCT01389102|3072641|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1669816|NCT01389102|3072641|Superiority or Other||||||<|0.0406|||||||ANCOVA||||
1669817|NCT01389102|3072641|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1669818|NCT01389102|3072642|Superiority or Other|||||||0.0004|||||||ANCOVA||||
1669819|NCT01389102|3072642|Superiority or Other|||||||0.0099|||||||ANCOVA||||
1669820|NCT01389102|3072642|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1669821|NCT01388491|3072696|Superiority or Other||Least Squares Mean Difference|14.3||||0.1731|2-Sided|95.0|-6.29|34.8||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II|||
1669822|NCT01388491|3072697|Superiority or Other||Least Squares Mean Difference|-0.1||||0.3903|2-Sided|95.0|-0.29|0.11||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II|||
1669823|NCT01388491|3072698|Superiority or Other||Least Squares Mean Difference|8.2||||0.7136|2-Sided|95.0|-35.92|52.39||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II|||
1669824|NCT01388491|3072699|Superiority or Other||Least Squares Mean Difference|361.6||||0.1148|2-Sided|95.0|-88.45|811.61||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II|||
1669825|NCT01388491|3072700|Superiority or Other||Least Squares Mean Difference|0.1||||0.0318|2-Sided|95.0|0.01|0.26||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II|||
1669826|NCT01388491|3072701|Superiority or Other||Least Squares Mean Difference|0.1||||0.0459|2-Sided|95.0|0.0|0.14||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II|||
1669827|NCT01388491|3072702|Superiority or Other||Least Squares Mean Difference|0.5||||0.8507|2-Sided|95.0|-4.87|5.91||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II|||
1669884|NCT01387815|3072814|Other|||||||0.181|||||||t-test, 2 sided||||
1669885|NCT01387815|3072815|Other|||||||0.008|||||||t-test, 2 sided||||
1669886|NCT01387815|3072816|Other|||||||0.452|||||||t-test, 2 sided||||
1669828|NCT01388491|3072703|Superiority or Other||Least Squares Mean Difference|2.9||||0.0143|2-Sided|95.0|0.58|5.13||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II|||
1669829|NCT01388491|3072704|Superiority or Other||Least Squares Mean Difference|0.3||||0.2522|2-Sided|95.0|-0.24|0.92||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II|||
1669830|NCT01388491|3072705|Superiority or Other||Least Squares Mean Difference|1.6||||0.344|2-Sided|95.0|-1.7|4.85||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II|||
1669831|NCT01388491|3072706|Superiority or Other||Least Squares Mean Difference|3.2||||0.2312|2-Sided|95.0|-2.08|8.58||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II|||
1669832|NCT01388491|3072707|Superiority or Other||Least Squares Mean Difference|-4.8||||0.0021|2-Sided|95.0|-7.87|-1.77||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II|||
1669833|NCT01388491|3072708|Superiority or Other||Least Squares Mean Difference|3.0||||0.839|2-Sided|95.0|-25.96|31.94||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I - Treatment II|||
1669834|NCT01388491|3072709|Superiority or Other||Least Squares Mean Difference|-11.8||||0.5892|2-Sided|95.0|-54.75|31.17||The p-value, least squares mean difference, and 95% CI for the treatment group comparison are based on a repeated measures ANCOVA with baseline, treatment, visit, and treatment-by-visit interaction as fixed factors, and subject as a random effect.|ANCOVA|Least Squares mean difference: Treatment I – Treatment II|||
1669835|NCT01388166|3072714|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1669836|NCT01388166|3072715|Superiority or Other|||||||0.0002|||||||t-test, 2 sided||||
1669837|NCT01388166|3072716|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1669838|NCT01387815|3072747|Other|||||||0.291|||||||t-test, 2 sided||||
1669839|NCT01387815|3072748|Other|||||||0.739|||||||t-test, 2 sided||||
1669840|NCT01387815|3072750|Other|||||||0.395|||||||t-test, 2 sided||||
1669841|NCT01387815|3072751|Other|||||||0.181|||||||t-test, 2 sided||||
1669842|NCT01387815|3072752|Other|||||||0.321|||||||t-test, 2 sided||||
1669843|NCT01387815|3072753|Other|||||||0.757|||||||t-test, 2 sided||||
1669844|NCT01387815|3072755|Other|||||||0.305|||||||t-test, 2 sided||||
1669845|NCT01387815|3072756|Other|||||||0.184|||||||t-test, 2 sided||||
1669846|NCT01387815|3072757|Other|||||||0.208|||||||t-test, 2 sided||||
1669847|NCT01387815|3072758|Other|||||||0.808|||||||t-test, 2 sided||||
1669848|NCT01387815|3072759|Other|||||||0.36|||||||t-test, 2 sided||||
1669849|NCT01387815|3072760|Other|||||||0.144|||||||t-test, 2 sided||||
1669850|NCT01387815|3072761|Other|||||||0.938|||||||t-test, 2 sided||||
1669851|NCT01387815|3072762|Other|||||||0.482|||||||t-test, 2 sided||||
1669852|NCT01387815|3072763|Other|||||||0.672|||||||t-test, 2 sided||||
1669853|NCT01387815|3072764|Other|||||||0.006|||||||t-test, 2 sided||||
1669854|NCT01387815|3072771|Other|||||||0.723|||||||Fisher Exact||||
1669855|NCT01387815|3072772|Other||||||>|0.999|||||||Fisher Exact||||
1669856|NCT01387815|3072773|Other|||||||0.364|||||||Fisher Exact||||
1669857|NCT01387815|3072777|Other|||||||0.495|||||||Fisher Exact||||
1669858|NCT01387815|3072778|Other|||||||0.747|||||||Fisher Exact||||
1669859|NCT01387815|3072779|Other|||||||0.714|||||||Fisher Exact||||
1669860|NCT01387815|3072781|Other||||||>|0.999|||||||Fisher Exact||||
1669861|NCT01387815|3072782|Other||||||>|0.999|||||||Fisher Exact||||
1669862|NCT01387815|3072786|Other||||||>|0.999|||||||Fisher Exact||||
1669863|NCT01387815|3072787|Other|||||||0.737|||||||Fisher Exact||||
1669864|NCT01387815|3072788|Other|||||||0.714|||||||Fisher Exact||||
1669865|NCT01387815|3072790|Other|||||||0.835|||||||t-test, 2 sided||||
1669866|NCT01387815|3072791|Other|||||||0.351|||||||t-test, 2 sided||||
1669867|NCT01387815|3072792|Other|||||||0.011|||||||Fisher Exact||||
1669868|NCT01387815|3072793|Other|||||||0.987|||||||Chi-squared||||
1669869|NCT01387815|3072794|Other|||||||0.657|||||||Chi-squared||||
1669870|NCT01387815|3072795|Other|||||||0.763|||||||t-test, 2 sided||||
1669871|NCT01387815|3072796|Other|||||||0.879|||||||t-test, 2 sided||||
1669872|NCT01387815|3072797|Other|||||||0.896|||||||t-test, 2 sided||||
1669873|NCT01387815|3072798|Other|||||||0.732|||||||Chi-squared||||
1669874|NCT01387815|3072799|Other|||||||0.623|||||||Chi-squared||||
1669875|NCT01387815|3072800|Other|||||||0.856|||||||Chi-squared||||
1669876|NCT01387815|3072803|Other|||||||0.575|||||||Chi-squared||||
1669877|NCT01387815|3072804|Other||||||>|0.999|||||||Fisher Exact||||
1669878|NCT01387815|3072805|Other|||||||0.92|||||||Chi-squared||||
1669879|NCT01387815|3072806|Other|||||||0.504|||||||Fisher Exact||||
1669880|NCT01387815|3072807|Other|||||||0.604|||||||Chi-squared||||
1669881|NCT01387815|3072808|Other|||||||0.415|||||||Chi-squared||||
1669901|NCT01387815|3072831|Other|||||||0.06|||||||Chi-squared|||"Comparison does not include the Missing category."|
1669902|NCT01387815|3072832|Other|||||||0.015|||||||Chi-squared|||"Comparison does not include the Missing category."|
1669903|NCT01387815|3072833|Other|||||||0.01||||||"Comparison does not include the Missing category."|Chi-squared||||
1669904|NCT01387815|3072834|Other|"Comparison does not include the Missing category."||||||0.017|||||||Chi-squared||||
1669905|NCT01387815|3072835|Other|||||||0.002|||||||Chi-squared|||"Comparison does not include the Missing category."|
1669906|NCT01387815|3072836|Other|||||||0.002|||||||Log Rank||||
1669907|NCT01387815|3072837|Other|||||||0.115|||||||t-test, 2 sided||||
1669908|NCT01387815|3072838|Other|||||||0.004|||||||t-test, 2 sided||||
1669909|NCT01387815|3072839|Other|||||||0.059|||||||t-test, 2 sided||||
1669910|NCT01387815|3072840|Other|||||||0.09|||||||t-test, 2 sided||||
1669911|NCT01387815|3072841|Other|||||||0.084|||||||t-test, 2 sided||||
1669912|NCT01387815|3072842|Other|||||||0.037|||||||t-test, 2 sided||||
1669913|NCT01387815|3072843|Other|||||||0.006|||||||t-test, 2 sided||||
1669914|NCT01387815|3072844|Other|||||||0.097|||||||t-test, 2 sided||||
1669915|NCT01387815|3072845|Other|||||||0.495|||||||t-test, 2 sided||||
1669916|NCT01387815|3072846|Other|||||||0.083|||||||t-test, 2 sided||||
1669917|NCT01387815|3072847|Other|||||||0.008|||||||t-test, 2 sided||||
1669918|NCT01387815|3072848|Other|||||||0.003|||||||t-test, 2 sided||||
1669919|NCT01387815|3072849|Other|||||||0.106|||||||t-test, 2 sided||||
1669920|NCT01387815|3072850|Other|||||||0.091|||||||t-test, 2 sided||||
1669921|NCT01387815|3072851|Other|||||||0.755|||||||t-test, 2 sided||||
1669922|NCT01387815|3072852|Other|||||||0.056|||||||t-test, 2 sided||||
1669923|NCT01387815|3072853|Other|||||||0.06|||||||t-test, 2 sided||||
1669924|NCT01387815|3072854|Other|||||||0.016|||||||t-test, 2 sided||||
1669925|NCT01387815|3072855|Other|||||||0.003|||||||t-test, 2 sided||||
1669926|NCT01387815|3072856|Other||||||<|0.001|||||||Chi-squared||||
1669927|NCT01387815|3072857|Other||||||<|0.001|||||||Chi-squared||||
1669928|NCT01387815|3072858|Other||||||<|0.001|||||||Chi-squared||||
1669929|NCT01387815|3072859|Other||||||<|0.001|||||||Chi-squared||||
1669930|NCT01387815|3072860|Other||||||<|0.001|||||||Log Rank||||
1669931|NCT01387815|3072861|Other||||||<|0.001|||||||Chi-squared|||Comparison does not include missing.|
1669932|NCT01387607|3072880|Superiority or Other||Mean Difference (Final Values)|-0.83|Standard Error of the Mean|0.3621||0.0226|2-Sided|95.0|-1.54|-0.12||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA||||
1669933|NCT01387607|3072881|Superiority or Other||Mean Difference (Final Values)|-0.378|Standard Error of the Mean|0.3595||0.2934||95.0|-1.09|0.33||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA||||
1669934|NCT01387607|3072882|Superiority or Other||Mean Difference (Final Values)|-3.616|Standard Error of the Mean|2.4019||0.1332|2-Sided|95.0|-8.34|1.11||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA||||
1669935|NCT01387607|3072883|Superiority or Other||Mean Difference (Final Values)|0.785|Standard Error of the Mean|0.673||0.2442|2-Sided|95.0|-0.54|2.11||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA||||
1669936|NCT01387607|3072884|Superiority or Other||Mean Difference (Final Values)|0.38|Standard Error of the Mean|1.0404||0.7149|2-Sided|95.0|-1.67|2.43||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA||||
1669937|NCT01387607|3072885|Superiority or Other||Mean Difference (Final Values)|-0.84|Standard Error of the Mean|0.8414||0.3186|2-Sided|95.0|-2.5|0.82||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA||||
1669938|NCT01387607|3072886|Superiority or Other||Mean Difference (Final Values)|0.765|Standard Error of the Mean|0.2115||0.0003|2-Sided|95.0|0.35|1.18||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures||||
1669939|NCT01387607|3072887|Superiority or Other||Mean Difference (Final Values)|7.396|Standard Error of the Mean|7.7309||0.3388|2-Sided|95.0|-7.76|22.55||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures||||
1669940|NCT01387607|3072888|Superiority or Other||Mean Difference (Final Values)|-0.655|Standard Error of the Mean|0.1223|<|0.0001|2-Sided|95.0|-0.89|-0.41||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures||||
1669941|NCT01387607|3072889|Superiority or Other||Mean Difference (Final Values)|0.016|Standard Error of the Mean|0.0677||0.8082|2-Sided|95.0|-0.12|0.15||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures||||
1669942|NCT01387607|3072890|Superiority or Other||Mean Difference (Final Values)|-17.172|Standard Error of the Mean|7.7785||0.0273|2-Sided|95.0|-32.42|-1.92||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures||||
1669943|NCT01387607|3072891|Superiority or Other||Mean Difference (Final Values)|-0.882|Standard Error of the Mean|0.1932|<|0.0001|2-Sided|95.0|-1.26|-0.5||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures||||
1669944|NCT01387607|3072892|Superiority or Other||Odds Ratio (OR)|1.12||||0.6767|2-Sided|95.0|0.67|1.87||Logistic regression model includes treatment and pooled center as factors and baseline value as covariate.|Regression, Logistic||||
1669974|NCT01387269|3072927|Superiority or Other|||||||0.0544|||||||Mixed Models Analysis|||Superiority analysis|
1669975|NCT01387269|3072928|Superiority or Other|||||||0.0004|||||||Mixed Models Analysis|||Superiority analysis|
1669945|NCT01387607|3072893|Superiority or Other||Mean Difference (Final Values)|-3.059|Standard Error of the Mean|1.6438||0.0637|2-Sided|95.0|-6.29|0.18||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA||||
1669946|NCT01387607|3072894|Superiority or Other||Mean Difference (Final Values)|4.194|Standard Error of the Mean|1.6428||0.0112|2-Sided|95.0|0.96|7.43||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for somnolence|
1669947|NCT01387607|3072894|Superiority or Other||Mean Difference (Final Values)|0.286|Standard Error of the Mean|0.1114||0.0106|2-Sided|95.0|0.07|0.51||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for quantity of sleep.|
1669948|NCT01387607|3072895|Superiority or Other||Mean Difference (Final Values)|9.03|Standard Error of the Mean|2.4485||0.0003|2-Sided|95.0|4.21|13.85||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for sleep adequacy.|
1669949|NCT01387607|3072895|Superiority or Other||Mean Difference (Final Values)|-2.355|Standard Error of the Mean|2.265||0.2993|2-Sided|95.0|-6.81|2.1||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for awaken short of breath.|
1669950|NCT01387607|3072895|Superiority or Other||Mean Difference (Final Values)|2.527|Standard Error of the Mean|2.1858||0.2485|2-Sided|95.0|-1.77|6.83||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA|||Statistical analysis for snoring.|
1669951|NCT01387607|3072896|Superiority or Other||Mean Difference (Final Values)|-3.427|Standard Error of the Mean|2.0152||0.09|2-Sided|95.0|-7.39|0.54||From the analysis of covariance (ANCOVA) with treatment and pooled center as factors and baseline value as covariate.|ANCOVA||||
1669952|NCT01387607|3072897|Superiority or Other||Odds Ratio (OR)|1.9683||||0.0189|2-Sided|95.0|1.1151|3.4742||From Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mantel-Haenszel method as pregabalin versus placebo.||
1669953|NCT01387607|3072898|Superiority or Other||Odds Ratio (OR)|1.8924||||0.0044|2-Sided|95.0|1.2007|2.9827||From Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mantel-Haenszel method as pregabalin versus placebo.||
1669954|NCT01387607|3072899|Superiority or Other||Mean Difference (Final Values)|-2.99|Standard Error of the Mean|1.6804||0.0762|2-Sided|95.0|-6.3|0.32||From the analysis of covariate (ANCOVA) with treatment and pooled center as factors, and baseline value as covariate.|ANCOVA||||
1669955|NCT01387607|3072900|Superiority or Other||Odds Ratio (OR)|1.4626||||0.151|2-Sided|95.0|0.8596|2.4886||Based on the combined categories from Cochran-Mantel-Haenszel test adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mentel-Haenszel method as pregabalin versus placebo.|Statistical analysis performed for PGIC endpoint re-categorized into any improvement (participants who were very much improved or much improved or minimally improved) and other.|
1669956|NCT01387607|3072900|Superiority or Other||Odds Ratio (OR)|1.4376||||0.1397|2-Sided|95.0|0.8732|2.3667||Based on the combined categories from Cochran-Mantel-Haenszel test adjusted for pooled center.|Cochran-Mantel-Haenszel||Overall odds ratio was calculated based on Mentel-Haenszel method as pregabalin versus placebo.|Statistical analysis performed for PGIC endpoint re-categorized into much/very much improved and other.|
1669957|NCT01387607|3072901|Superiority or Other||Mean Difference (Final Values)|-0.73|Standard Error of the Mean|0.1906||0.0001|2-Sided|95.0|-1.1|-0.36||From a repeated measures analysis (MMRM) with treatment, pooled center, week, and treatment-by-week interaction as factors, and baseline value as covariate.|Mixed-effects model repeated measures||||
1669958|NCT01387594|3072905|Superiority or Other||Geometric Mean Ratio (GMR)|1.33|||||2-Sided|80.0|1.13|1.56|||||The lower limit of 80% CI greater than 0.5 indicates the statistical significance at alpha=0.1 level.|The null hypothesis is the (median) percent decrease in total lymphocytes count is greater or equal to 50%, equivalently indicating that the geometric mean ratio (GMR: post-treatment/pretreatment) in total lymphocyte counts is less than or equal to 0.5.|
1669959|NCT01387542|3072909|Superiority or Other|||||||0|||||||Paired t-test||||
1669960|NCT01387542|3072910|Superiority or Other|||||||0.001|||||||Paired t-test||||
1669961|NCT01387542|3072911|Superiority or Other|||||||0.009|||||||Paired t-test||||
1669962|NCT01387542|3072912|Superiority or Other|||||||0|||||||Friedman test||||
1669963|NCT01387347|3072919|Superiority or Other|||||||0.0244|||||||t-test, 2 sided|||Comparison of discomfort score between the placebo and Thymosin beta 4 groups on Day 28|
1669964|NCT01387347|3072919|Superiority or Other||Mean Difference (Final Values)|0.3||||0.3734|2-Sided||||||t-test, 2 sided|||Comparison between the groups uses a two-sample t-test assuming unequal variances, assessed at the alpha = 0.05 level.|
1669965|NCT01387347|3072920|Superiority or Other|||||||0.021|||||||t-test, 2 sided|||Comparison of superior corneal fluorescein staining score between the placebo and Thymosin beta 4 groups|
1669966|NCT01387347|3072920|Superiority or Other|||||||0.0075|||||||t-test, 2 sided|||Comparison of central corneal fluorescein staining score between the placebo and Thymosin beta 4 groups|
1669967|NCT01387347|3072920|Superiority or Other||Mean Difference (Final Values)|0.18||||0.2596|||||||t-test, 2 sided|||Inferior corneal fluorescein staining score at Day 29(primary sign) was summarized using descriptive statistics (number of observations, mean, standard deviation, median, minimum, and maximum). Active treatment was compared to placebo using a two-sample t-test assuming unequal variances, assessed at the α = 0.05 level|
1669968|NCT01387282|3072921|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|||Superiority analysis|
1669969|NCT01387282|3072922|Superiority or Other|||||||0.8637|||||||Mixed Models Analysis|||Superiority analysis|
1669970|NCT01387282|3072923|Superiority or Other|||||||0.0016|||||||Mixed Models Analysis|||Superiority analysis|
1669971|NCT01387282|3072924|Superiority or Other|||||||0.648|||||||Wilcoxon rank sum test|||Superiority analysis|
1669972|NCT01387282|3072925|Superiority or Other||||||<|0.0001|||||||Wilcoxon rank sum test|||Superiority analysis|
1669973|NCT01387269|3072926|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|||Superiority analysis|
1669976|NCT01387269|3072929|Superiority or Other|||||||0.1475|||||||Wilcoxon rank sum test|||Superiority analysis|
1669977|NCT01387269|3072930|Superiority or Other||||||<|0.0001|||||||Wilcoxon rank sum test|||Superiority analysis|
1669978|NCT01387230|3072933|Superiority or Other||Least squares mean difference|0.152|||<|0.001|2-Sided|95.0|0.076|0.229|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean difference=UMEC 125 µg minus Placebo.||
1669979|NCT01387230|3072933|Superiority or Other||Least squares mean difference|0.127|||<|0.001|2-Sided|95.0|0.052|0.202|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|Least squares mean difference=UMEC 62.5 µg minus Placebo.||
1669980|NCT01387178|3072935|Superiority or Other||Hazard Ratio (HR)|0.953||||0.0962||95.0|0.901|1.009||Risk of Any COPD Exacerbation|Regression, Cox||||
1669981|NCT01387178|3072935|Superiority or Other||Hazard Ratio (HR)|0.864||||0.0406||95.0|0.752|0.994||Risk of Severe COPD Exacerbations|Regression, Cox||||
1669982|NCT01387178|3072935|Superiority or Other||Hazard Ratio (HR)|0.964||||0.2198||95.0|0.909|1.022||Risk of Moderate COPD Exacerbations|Regression, Cox||||
1669983|NCT01387178|3072936|Superiority or Other||Adjusted Mean|3304.0|||||2-Sided|95.0|3221.0|3386.0|||||The mean predicted cost for total healthcare services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669984|NCT01387178|3072936|Superiority or Other||Adjusted Mean|2991.0|||||2-Sided|95.0|2922.0|3059.0|||||The mean predicted cost for total healthcare services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669985|NCT01387178|3072936|Superiority or Other||Adjusted Mean|1566.0|||||2-Sided|95.0|1438.0|1695.0|||||The mean predicted cost for inpatient and emergency department services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669986|NCT01387178|3072936|Superiority or Other||Adjusted Mean|1175.0|||||2-Sided|95.0|1083.0|1267.0|||||The mean predicted cost for inpatient and emergency department services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669987|NCT01387178|3072936|Superiority or Other||Adjusted Mean|1250.0|||||2-Sided|95.0|1234.0|1266.0|||||The mean predicted cost for pharmacy services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669988|NCT01387178|3072936|Superiority or Other||Adjusted Mean|1267.0|||||2-Sided|95.0|1251.0|1283.0|||||The mean predicted cost for pharmacy services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669989|NCT01387178|3072936|Superiority or Other||Adjusted Mean|1080.0|||||2-Sided|95.0|1022.0|1138.0|||||The mean predicted cost for other outpatient and ancillary services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669990|NCT01387178|3072936|Superiority or Other||Adjusted Mean|873.0|||||2-Sided|95.0|827.0|919.0|||||The mean predicted cost for other outpatient and ancillary services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669991|NCT01387178|3072936|Superiority or Other||Adjusted Mean|295.0|||||2-Sided|95.0|290.0|299.0|||||The mean predicted cost for office visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669992|NCT01387178|3072936|Superiority or Other||Adjusted Mean|231.0|||||2-Sided|95.0|227.0|234.0|||||The mean predicted cost for office visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669993|NCT01387178|3072936|Superiority or Other||Adjusted Mean|51.0|||||2-Sided|95.0|49.0|53.0|||||The mean predicted cost for emergency department visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669994|NCT01387178|3072936|Superiority or Other||Adjusted Mean|61.0|||||2-Sided|95.0|58.0|63.0|||||The mean predicted cost for emergency department visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669995|NCT01387178|3072936|Superiority or Other||Adjusted Mean|11545.0|||||2-Sided|95.0|8827.0|14263.0|||||The mean predicted cost for inpatient services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669996|NCT01387178|3072936|Superiority or Other||Adjusted Mean|7451.0|||||2-Sided|95.0|5857.0|9045.0|||||The mean predicted cost for inpatient services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.||
1669997|NCT01387022|3072953|Superiority or Other|||||||0.267|||||||Fisher Exact||||
1669998|NCT01387022|3072955|Superiority or Other|||||||0.481|||||||Wilcoxon (Mann-Whitney)||||
1669999|NCT01387022|3072956|Superiority or Other|||||||1|||||||Fisher Exact||||
1670000|NCT01386983|3072957|Superiority or Other|||||||0.0002|||||||Generalized linear model|Gamma distribution with log-link function was used.|||
1670001|NCT01386983|3072958|Superiority or Other||Cox Proportional Hazard|3.406||||0.0128|2-Sided|95.0|1.297|8.941|||Regression, Cox||||
1670002|NCT01386944|3072962|Superiority or Other||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.0|-1.5|||||||
1670003|NCT01386944|3072963|Superiority or Other||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.5|-1.5|||||||
1670004|NCT01386944|3072964|Superiority or Other||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.5|-1.5|||||||
1670005|NCT01386944|3072965|Superiority or Other||Hodges-Lehmann Estimate|-2.0||||||95.0|-2.0|-1.5|||||||
1670846|NCT01372774|3074632|Superiority|||||||0.31|||||||Chi-squared||||
1670006|NCT01386944|3072966|Superiority or Other||Hodges-Lehmann Estimate|-1.5|||||2-Sided|95.0|-1.5|-1.0|||||||
1670007|NCT01386944|3072967|Superiority or Other||Hodges-Lehmann Estimate|-0.5|||||2-Sided|95.0|-1.0|-0.5|||||||
1670008|NCT01386606|3073055|Superiority or Other||||||<|0.001||||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 6. Modeling change from baseline by treatment group.|
1670009|NCT01386606|3073055|Superiority or Other||||||<|0.001||||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 4. Modeling change from baseline by treatment group.|
1670010|NCT01386606|3073055|Superiority or Other||||||<|0.001||||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning FSH at Week 2. Modeling change from baseline by treatment group.|
1670011|NCT01386606|3073057|Superiority or Other||Pearson Correlation|0.89643|||<|0.0001|2-Sided||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cmax at Week 6.|
1670012|NCT01386606|3073057|Superiority or Other||Pearson Correlation|0.86541|||<|0.0001|2-Sided||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cmin at Week 6.|
1670013|NCT01386606|3073057|Superiority or Other||Pearson Correlation|0.90993|||<|0.0001|2-Sided||||||t-test, 2 sided|||Pearson correlation between 9 am morning testosterone and serial testosterone Cavg at Week 6.|
1670014|NCT01386606|3073058|Superiority or Other||||||<|0.001||||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 6. Modeling change from baseline by treatment group.|
1670015|NCT01386606|3073058|Superiority or Other||||||<|0.001||||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 4. Modeling change from baseline by treatment group.|
1670016|NCT01386606|3073058|Superiority or Other||||||<|0.001||||||P-value for treatment group effect.|ANOVA|||ANOVA results - change from baseline in morning LH at Week 2. Modeling change from baseline by treatment group.|
1670017|NCT01386606|3073059|Superiority or Other||Regression Coefficient|0.58|||<|0.001|2-Sided|95.0|0.37|0.79||P-value for morning total testosterone (adjusted for treatment effect if treatment group is significant).|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."|
1670018|NCT01386606|3073059|Superiority or Other||Regression Coefficient|-148.5|||<|0.011|2-Sided|95.0|-242.9|-54.05||P-value for Androxal 6.25 mg group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."|
1670019|NCT01386606|3073059|Superiority or Other||Regression Coefficient|-110.9|||<|0.068|2-Sided|95.0|-210.6|-11.23||P-value for Androxal 12.5 mg group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."|
1670020|NCT01386606|3073059|Superiority or Other||Regression Coefficient|-45.77|||<|0.436|2-Sided|95.0|-143.5|51.98||P-value for Androxal 25 mg treatment group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."|
1670021|NCT01386606|3073059|Superiority or Other||||||<|0.056||||||P-value of treatment group.|Regression, Linear|||"Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.~Modeling 24 hour average total testosterone by morning testosterone and treatment group."|
1670022|NCT01386125|3073069|Superiority or Other||Difference is LS Means|-0.3|||<|0.0001|2-Sided|95.0|-0.45|-0.15|||Constrained longitudinal data analysis||||
1670023|NCT01386125|3073070|Superiority or Other||Difference in LS Means|-0.14||||0.0007|2-Sided|95.0|-0.22|-0.06|||ANCOVA||||
1670024|NCT01385995|3073075|Superiority or Other||Mean Difference (Final Values)|13.3||||0.002|2-Sided|95.0|5.2|22.1|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and the Insulin Sensitivity Index (ISI(0,120)), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) >=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.|
1670025|NCT01385995|3073075|Superiority or Other||Mean Difference (Final Values)|3.7||||0.2|2-Sided|95.0|-2.0|9.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and the Insulin Sensivity Index, between CPAP and sham-CPAP.|
1670026|NCT01385995|3073076|Superiority or Other||Mean Difference (Final Values)|-14.1||||0.08|2-Sided|95.0|-27.5|1.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin resistance, in this case Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) >=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.|
1670027|NCT01385995|3073076|Superiority or Other||Mean Difference (Final Values)|-7.5||||0.18|2-Sided|95.0|-17.6|3.8|||Regression, Linear|||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and Homeostasis Model Assessment-Insulin Resistance (HOMA-IR), between CPAP and sham-CPAP.|
1670028|NCT01385995|3073077|Superiority or Other||Mean Difference (Final Values)|-28.7||||0.002|2-Sided|95.0|-46.5|-10.9|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) >=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.|
1670176|NCT01381900|3073498|Superiority or Other||Odds Ratio (OR)|3.26|||||2-Sided|95.0|2.09|5.09|||||||
1670029|NCT01385995|3073077|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.1|2-Sided|95.0|-5.2|0.5|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case fasting insulin, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) >=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=23.|
1670030|NCT01385995|3073077|Superiority or Other||Mean Difference (Final Values)|-10.7||||0.12|2-Sided|95.0|-23.3|2.8|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case, 2-hour oral glucose tolerance test (OGTT) insulin, between CPAP and sham-CPAP.|
1670031|NCT01385995|3073077|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.14|2-Sided|95.0|-3.4|0.5|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of insulin indices, in this case, fasting insulin, between CPAP and sham-CPAP.|
1670032|NCT01385995|3073078|Superiority or Other||Mean Difference (Final Values)|-11.6||||0.08|2-Sided|95.0|-24.6|1.3|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case 2-hour oral glucose tolerance test (OGTT) glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) >=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N= 25.|
1670033|NCT01385995|3073078|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.86|2-Sided|95.0|-3.3|2.7|||Regression, Linear|||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case fasting glucose, between CPAP and sham-CPAP, stratified for the most severe sleep apnea group (Apnea-Hypopnea Index (AHI) >=30) in order to assess whether the differences in the effect of CPAP on outcomes were observed according to sleep apnea severity. N=25.|
1670034|NCT01385995|3073078|Superiority or Other||Mean Difference (Final Values)|-7.3||||0.11|2-Sided|95.0|-16.3|1.7|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, AHI, gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between measures of glucose indices, in this case, 2 hour OGTT, and therapeutic CPAP vs. Sham.|
1670035|NCT01385995|3073078|Superiority or Other||Mean Difference (Final Values)|0.9||||0.38|2-Sided|95.0|-1.2|3.0|||Regression, Linear|Adjusted for period, baseline level of the outcome variable, BMI, Apnea-Hypopnea Index (AHI), gender and race.||Based on an intent-to-treat approach, a linear mixed effect model was used to estimate the association between therapy and measures of glucose indices, in this case fasting glucose, between CPAP and sham-CPAP.|
1670036|NCT01385995|3073079|Superiority or Other||Odds Ratio (OR)|1.3||||0.57|2-Sided|95.0|0.52|3.24|||Generalized Estimating Equation|Controlled for period and baseline 2 hour OGTT glucose level.||Based on an intent to treat approach a Generalized Estimating Equation (GEE) was used to estimate the effect of therapy (CPAP or Sham) on the odds of normalization of Impaired Glucose Tolerance (IGT). This model provides an estimate of the odds ratio of normalizing the 2-hour oral glucose tolerance test (OGTT) with CPAP compared with Sham-CPAP.|
1670037|NCT01385748|3073081|Superiority or Other||Hazard Ratio (HR)|0.692||||0.102|2-Sided|95.0|0.444|1.078|||Log Rank|Significance threshold = 5%|||
1670038|NCT01385748|3073081|Superiority or Other||Hazard Ratio (HR)|0.601||||0.054|2-Sided|95.0|0.357|1.012|||Log Rank|Significance threshold = 5%|||
1670039|NCT01385748|3073081|Superiority or Other||Hazard Ratio (HR)|0.824||||0.388|2-Sided|95.0|0.484|1.401|||Log Rank|Significance threshold = 5%|||
1670040|NCT01385748|3073082|Superiority or Other|||||||0.064|||||||Chi-squared|Significance threshold = 5%|||
1670041|NCT01385748|3073082|Superiority or Other|||||||0.169|||||||Chi-squared||||
1670042|NCT01385748|3073082|Superiority or Other|||||||0.063||||||Significance threshold = 5%|Chi-squared||||
1670043|NCT01385748|3073083|Superiority or Other|||||||0.295|||||||Kruskal-Wallis|Significance threshold = 5%|||
1670044|NCT01385748|3073083|Superiority or Other|||||||0.61|||||||Kruskal-Wallis|Significance threshold = 5%|||
1670045|NCT01385748|3073083|Superiority or Other|||||||0.176|||||||Kruskal-Wallis|Significance threshold = 5%|||
1670046|NCT01385748|3073084|Superiority or Other||Hazard Ratio (HR)|0.764||||0.235|2-Sided|95.0|0.489|1.193|||Log Rank|Significance threshold = 5%|||
1670047|NCT01385748|3073084|Superiority or Other||Hazard Ratio (HR)|0.817||||0.424|2-Sided|95.0|0.493|1.353|||Log Rank|Significance threshold = 5%|||
1670048|NCT01385748|3073084|Superiority or Other||Hazard Ratio (HR)|0.698||||0.199|2-Sided|95.0|0.398|1.223||Significance threshold = 5%|Log Rank||||
1670049|NCT01385748|3073086|Superiority or Other|||||||0.971||||||Significance threshold = 5%|Wilcoxon (Mann-Whitney)||||
1670050|NCT01385748|3073086|Superiority or Other|||||||0.807||||||Significance threshold = 5%|Wilcoxon (Mann-Whitney)||||
1670051|NCT01385748|3073089|Superiority or Other||Hazard Ratio (HR)|0.754||||0.211|2-Sided|95.0|0.484|1.175|||Log Rank|The log rank test at 5% significance level was used.|||
1670052|NCT01385748|3073089|Superiority or Other||Hazard Ratio (HR)|0.817||||0.421|2-Sided|95.0|0.495|1.35|||Log Rank|The log rank test at 5% significance level was used.|||
1670053|NCT01385748|3073089|Superiority or Other||Hazard Ratio (HR)|0.677||||0.165|2-Sided|95.0|0.387|1.186|||Log Rank|The log rank test at 5% significance level was used.|||
1670054|NCT01385371|3073105|Superiority or Other||Median Difference (Final Values)|0.15||||0.644|2-Sided|95.0|-0.4|0.6|||Wilcoxon Rank Sum Test||||
1670055|NCT01385371|3073106|Superiority or Other||Mean Difference (Final Values)|-0.62||||0.0001|2-Sided|95.0|-0.94|-0.31||A zero-inflated log-normal mixed distribution model was used with treatment, baseline asthma status, age category (<18 or >=18 years) and pollen region as covariates.|Zero-Inflated Log-Normal Model||||
1670056|NCT01385371|3073107|Superiority or Other||Median Difference (Final Values)|-0.69|||<|0.001|2-Sided|95.0|-0.9|-0.2|||Wilcoxon Rank Sum Test||||
1670057|NCT01385371|3073108|Superiority or Other||Mean Difference (Final Values)|-0.48||||0.0003|2-Sided|95.0|-0.73|-0.22||A zero-inflated log-normal mixed distribution model was used with treatment, baseline asthma status, age category (<18 or >=18 years) and pollen region as covariates.|Zero-Inflated Log-Normal Model||||
1670058|NCT01385371|3073109|Superiority or Other||Median Difference (Final Values)|-0.13||||0.027||95.0|-0.2|0.0|||Wilcoxon Rank Sum Test||||
1670059|NCT01385371|3073110|Superiority or Other||Median Difference (Final Values)|-1.33|||<|0.001|2-Sided|95.0|-1.4|-0.5|||Wilcoxon Rank Sum Test||||
1670060|NCT01385371|3073111|Superiority or Other||Median Difference (Final Values)|-0.64||||0.001|2-Sided|95.0|-0.7|-0.2|||Wilcoxon Rank Sum Test||||
1670061|NCT01385371|3073112|Superiority or Other||Median Difference (Final Values)|-0.98|||<|0.001||95.0|-1.2|-0.4|||Wilcoxon Rank Sum Test||||
1670062|NCT01385202|3073134|Superiority or Other||Primary effectiveness rate|74.0|||||2-Sided|95.0|66.0|82.0|||||The 95% confidence intervals above were calculated using the Kaplan-Meier (KM) method.||
1670063|NCT01385202|3073134|Superiority or Other||Primary effectiveness rate|70.2|||<|0.0001|2-Sided|95.0|60.9|78.4||In the worst-case scenario analysis, over seventy-percent (70.2%, 80/114) of the primary effectiveness cohort (PEC) were free from documented symptomatic atrial tachyarrhythmias during their effectiveness evaluation period.|Fisher Exact|The lower bound of the 95% confidence intervals was 60.9%, significantly higher than the pre-determined performance goal of 50% (p<0.0001).|The confidence intervals above are the 95% exact binomial confidence intervals.|The null hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be less than or equal to the pre-determined performance criterion of 50%. The alternative hypothesis was that the rate of freedom from documented symptomatic AF/AFL/AT at 12 months would be greater than the pre-determined performance criterion of 50%.|
1670064|NCT01385137|3073142|Superiority or Other||Mean Difference (Final Values)|2.14||||0.21|2-Sided|95.0|-1.16|5.44|||Regression, Linear||||
1670065|NCT01385137|3073143|Superiority or Other||Mean Difference (Final Values)|0.72||||0.77|2-Sided|95.0|-4.17|5.6|||Regression, Linear||||
1670066|NCT01385137|3073144|Superiority or Other||Mean Difference (Final Values)|-2.13||||0.42|2-Sided|95.0|-7.3|3.04|||Regression, Linear||||
1670067|NCT01385137|3073146|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.58|2-Sided|95.0|-0.79|0.44|||Regression, Linear||||
1670068|NCT01385098|3073147|Superiority or Other|||||||0.01||||||Change from preoperative to 12 weeks|Wilcoxon (Mann-Whitney)||||
1670069|NCT01385098|3073147|Superiority or Other|||||||0.013||||||Change from preoperative to 12 weeks|Wilcoxon (Mann-Whitney)||||
1670070|NCT01385098|3073148|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1670071|NCT01383616|3073310|Superiority|||||||0.24|||||||t-test, 2 sided||||
1670072|NCT01383616|3073311|Superiority|||||||0.87|||||||t-test, 2 sided||||
1670073|NCT01383616|3073312|Superiority|||||||0.36|||||||t-test, 2 sided||||
1670074|NCT01383616|3073313|Superiority|||||||0.9|||||||t-test, 2 sided||||
1670075|NCT01383616|3073314|Superiority|||||||0.67|||||||t-test, 2 sided||||
1670076|NCT01383616|3073315|Superiority|||||||0.17|||||||t-test, 2 sided||||
1670077|NCT01383616|3073316|Superiority|||||||0.93|||||||t-test, 2 sided||||
1670078|NCT01383616|3073317|Superiority|||||||0.17|||||||t-test, 2 sided||||
1670079|NCT01383616|3073318|Superiority|||||||0.008|||||||t-test, 2 sided||||
1670080|NCT01383616|3073319|Superiority|||||||0.85|||||||t-test, 2 sided|||Comparison of 3 month ODI Score between Unipedicular and Bipedicular kyphoplasty groups|
1670081|NCT01383499|3073330|Superiority or Other||Mean Difference (Final Values)|0.029|Standard Error of the Mean|0.023|||2-Sided|95.0|-0.016|0.074||||||Tio R2.5 minus Tio R1.25|
1670082|NCT01383499|3073330|Superiority or Other||Mean Difference (Final Values)|-0.017|Standard Error of the Mean|0.023|||2-Sided|95.0|-0.063|0.028||||||Tio R5 minus Tio R2.5|
1670083|NCT01383499|3073330|Superiority or Other||Mean Difference (Final Values)|0.012|Standard Error of the Mean|0.023|||2-Sided|95.0|-0.034|0.057||||||Tio R5 minus Tio R1.25|
1670084|NCT01383499|3073330|Superiority or Other||Mean Difference (Final Values)|0.075|Standard Error of the Mean|0.023||0.0011|2-Sided|95.0|0.03|0.12|||Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R1.25 minus Placebo|
1670085|NCT01383499|3073330|Superiority or Other||Mean Difference (Final Values)|0.104|Standard Error of the Mean|0.023|<|0.0001|2-Sided|95.0|0.059|0.149||Second step of closed testing procedure. If this statistical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as random effect.||Tio R2.5 minus Placebo|
1670086|NCT01383499|3073330|Superiority or Other||Mean Difference (Final Values)|0.087|Standard Error of the Mean|0.023|<|0.0002|2-Sided|95.0|0.042|0.132||First step of closed testing procedure, where the active treatments are compared to placebo. If this statistical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as random effect.||Tio R5 minus Placebo|
1670087|NCT01383421|3073343|Superiority||LS Mean Between Group Change|0.0|Standard Error of the Mean|0.0526||0.56|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|P value is from an ANCOVA model adjusting for Baseline.||Concern|
1670088|NCT01383421|3073343|Superiority||LS Mean Between Group Change|0.1|Standard Error of the Mean|0.0429||0.019|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|P value is from an ANCOVA model adjusting for Baseline.||Necessity|
1670089|NCT01383421|3073347|Superiority||LS Mean Difference|0.884|Standard Error of the Mean|0.585||0.131|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78|
1670090|NCT01383421|3073347|Superiority||LS Mean Difference|0.772|Standard Error of the Mean|0.599||0.198|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52|
1670091|NCT01383421|3073347|Superiority||LS Mean Difference|0.817|Standard Error of the Mean|0.572||0.154|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24|
1670092|NCT01383421|3073348|Superiority||LS Mean Difference|1.823|Standard Error of the Mean|1.657||0.272|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects|
1670093|NCT01383421|3073348|Superiority||LS Mean Difference|5.997|Standard Error of the Mean|1.775|<|0.001|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction|
1670094|NCT01383421|3073348|Superiority||LS Mean Difference|4.929|Standard Error of the Mean|1.929|<|0.011|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness|
1670095|NCT01383421|3073348|Superiority||LS Mean Difference|2.324|Standard Error of the Mean|1.177|<|0.049|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience|
1670096|NCT01383421|3073349|Superiority||LS Mean Difference|1.885|Standard Error of the Mean|1.704||0.269|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects|
1670097|NCT01383421|3073349|Superiority||LS Mean Difference|5.572|Standard Error of the Mean|1.756||0.002|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction|
1670098|NCT01383421|3073349|Superiority||LS Mean Difference|3.124|Standard Error of the Mean|1.93||0.106|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness|
1670099|NCT01383421|3073349|Superiority||LS Mean Difference|2.728|Standard Error of the Mean|1.183||0.021|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience|
1670100|NCT01383421|3073350|Superiority||LS Mean Difference|1.705|Standard Error of the Mean|1.769||0.335|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM side effects|
1670101|NCT01383421|3073350|Superiority||LS Mean Difference|5.473|Standard Error of the Mean|1.866||0.003|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM global satisfaction|
1670102|NCT01383421|3073350|Superiority||LS Mean Difference|2.843|Standard Error of the Mean|2.042||0.164|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM effectiveness|
1670103|NCT01383421|3073350|Superiority||LS Mean Difference|2.973|Standard Error of the Mean|1.245||0.017|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||TSQM convenience|
1670104|NCT01383421|3073351|Superiority||LS Mean Difference|-5.537|Standard Error of the Mean|1.624|<|0.001|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment|
1670105|NCT01383421|3073351|Superiority||LS Mean Difference|-2.334|Standard Error of the Mean|3.159|<|0.461|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment|
1670106|NCT01383421|3073351|Superiority||LS Mean Difference|-0.817|Standard Error of the Mean|2.598|<|0.753|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism|
1670107|NCT01383421|3073351|Superiority||LS Mean Difference|-0.409|Standard Error of the Mean|2.548|<|0.873|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism|
1670108|NCT01383421|3073352|Superiority||LS Mean Difference|-3.792|Standard Error of the Mean|1.611||0.019|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment|
1670109|NCT01383421|3073352|Superiority||LS Mean Difference|-0.471|Standard Error of the Mean|3.205||0.883|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment|
1670110|NCT01383421|3073352|Superiority||LS Mean Difference|-0.527|Standard Error of the Mean|2.523||0.835|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism|
1670111|NCT01383421|3073352|Superiority||LS Mean Difference|0.38|Standard Error of the Mean|2.736||0.89|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism|
1670112|NCT01383421|3073353|Superiority||LS Mean Difference|-3.552|Standard Error of the Mean|1.561||0.023|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI activity impairment|
1670113|NCT01383421|3073353|Superiority||LS Mean Difference|1.207|Standard Error of the Mean|3.126||0.7|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI overall work impairment|
1670114|NCT01383421|3073353|Superiority||LS Mean Difference|-0.824|Standard Error of the Mean|2.441||0.736|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI presenteeism|
1670115|NCT01383421|3073353|Superiority||LS Mean Difference|1.333|Standard Error of the Mean|2.725||0.625|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||WPAI absenteeism|
1670116|NCT01383421|3073357|Superiority||LS Mean Difference|-2.734|Standard Error of the Mean|0.872||0.002|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78|
1670117|NCT01383421|3073357|Superiority||LS Mean Difference|-2.549|Standard Error of the Mean|0.818||0.002|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52|
1670118|NCT01383421|3073357|Superiority||LS Mean Difference|-1.791|Standard Error of the Mean|0.788||0.023|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24|
1670119|NCT01383421|3073358|Superiority||LS Mean Difference|-2.447|Standard Error of the Mean|0.945||0.01|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78|
1670120|NCT01383421|3073358|Superiority||LS Mean Difference|-2.697|Standard Error of the Mean|0.903||0.003|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52|
1670121|NCT01383421|3073358|Superiority||LS Mean Difference|-1.686|Standard Error of the Mean|0.893||0.059|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24|
1670122|NCT01383421|3073359|Superiority||LS Mean Difference|-0.233|Standard Error of the Mean|0.098||0.018|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 78|
1670123|NCT01383421|3073359|Superiority||LS Mean Difference|-0.26|Standard Error of the Mean|0.094||0.006|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 52|
1670124|NCT01383421|3073359|Superiority||LS Mean Difference|-0.203|Standard Error of the Mean|0.092||0.027|2-Sided|||||Statistical significance was set at P = 0.05.|ANCOVA|LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values.||Week 24|
1670125|NCT01383421|3073361|Superiority|||||||0.003||||||Statistical significance was set at P = 0.05.|Chi-squared||||
1670126|NCT01383421|3073363|Superiority|||||||0.058||||||Statistical significance was set at P = 0.05.|Chi-squared||||
1670127|NCT01383421|3073365|Superiority||||||<|0.001||||||Statistical significance was set at P = 0.05.|Chi-squared||||
1670128|NCT01383356|3073366|Non-Inferiority or Equivalence|BE, AUC0-inf was no BE criteria|GMR, potency corrected (percent)|108.0||||||90.0|105.0|112.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).|
1670129|NCT01383356|3073366|Non-Inferiority or Equivalence|Bioequivalence (BE), AUC0-inf was no BE criteria|Geometric mean ratio (percent)|105.0||||||90.0|101.0|108.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-inf and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.|
1670130|NCT01383356|3073367|Non-Inferiority or Equivalence|Bioequivalence|GMR, potency corrected (percent)|108.0||||||90.0|105.0|112.0|||||Lina/Met 2.5mg/500mg vs.Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of DP of Met in single tablet and DP of Met in combination tablet).|
1670131|NCT01383356|3073367|Non-Inferiority or Equivalence|Bioequivalence|Geometric mean ratio (percent)|105.0||||||90.0|101.0|108.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|The two formulations are shown to be bioequivalent if the 90 percent confidence interval of geometric mean ratio is entirely contained within the 80 to125 percent range both on measured data (statistical analysis 1) and potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed AUC0-t and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.|
1670132|NCT01383356|3073368|Non-Inferiority or Equivalence|Bioequivalence|GMR, potency corrected (percent)|122.0|||||2-Sided|90.0|114.0|130.0|||||Lina/Met 2.5mg/500mg vs. Lina 2.5mg plus Met 500mg.|ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction. Results were potency corrected (GMR multiplied by the quotient of drug potency (DP) of Met in single tablet and DP of Met in combination tablet).|
1670133|NCT01383356|3073368|Non-Inferiority or Equivalence|Bioequivalence|Geometric mean ratio (GMR) in percent|118.0|||||2-Sided|90.0|111.0|125.0|||||Lina/Met 2.5mg/500mg versus (vs.) Lina 2.5mg plus Met 500mg.|The two formulations are shown to be bioequivalent if the geometric mean ratio is contained within the 80 to 125 percent range both on measured data (statistical analysis 1) and on potency corrected data (percent potency of label claim) (statistical analysis 2). ANOVA was applied to log-transformed Cmax and included study, subject-within-study, period-within-study, treatment and study-by-treatment interaction.|
1670134|NCT01383174|3073381|Superiority or Other|||||||0.226||||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis||||
1670135|NCT01383174|3073382|Superiority or Other|||||||0.005||||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis||||
1670136|NCT01383174|3073383|Superiority or Other|||||||0.045||||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis||||
1670137|NCT01383174|3073384|Superiority or Other|||||||0.03||||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis||||
1670537|NCT01378065|3074027|Superiority or Other (legacy)||||||<|0.001|||||||t-test, 2 sided||||
1670138|NCT01383174|3073385|Superiority or Other|||||||0.267||||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis||||
1670139|NCT01383174|3073386|Superiority or Other|||||||0.013||||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis||||
1670140|NCT01383174|3073387|Superiority or Other|||||||0.004||||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis||||
1670141|NCT01383174|3073388|Superiority or Other|||||||0.025||||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis||||
1670142|NCT01383174|3073389|Superiority or Other|||||||0.465||||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis||||
1670143|NCT01383174|3073390|Superiority or Other|||||||0.015||||||P-value represents the significance of the time by treatment group interaction from the repeated-measures linear regression model. For consistency with the manuscript, we report here the absolute means and standard deviations.|Mixed Models Analysis||||
1670144|NCT01383161|3073391|Superiority|||||||0.6|||||||t-test, 2 sided||||
1670145|NCT01383161|3073391|Superiority|||||||0.04|||||||t-test, 2 sided||||
1670146|NCT01383161|3073391|Superiority|||||||0.3|||||||mixed-effects general linear model||||
1670147|NCT01383161|3073392|Superiority|||||||0.1|||||||t-test, 2 sided||||
1670148|NCT01383161|3073392|Superiority|||||||0.0001|||||||t-test, 2 sided||||
1670149|NCT01383161|3073392|Superiority|||||||0.04|||||||mixed-effects general linear model||||
1670150|NCT01383161|3073393|Superiority|||||||0.5|||||||t-test, 2 sided||||
1670151|NCT01383161|3073393|Superiority|||||||0.002|||||||t-test, 2 sided||||
1670152|NCT01383161|3073393|Superiority|||||||0.08|||||||mixed-effects general linear model||||
1670153|NCT01383161|3073394|Superiority|||||||0.8|||||||t-test, 2 sided||||
1670154|NCT01383161|3073394|Superiority|||||||0.002|||||||t-test, 2 sided||||
1670155|NCT01383161|3073394|Superiority|||||||0.05|||||||mixed-effects general linear model||||
1670156|NCT01383161|3073395|Superiority|||||||0.8|||||||t-test, 2 sided||||
1670157|NCT01383161|3073395|Superiority|||||||0.006|||||||t-test, 2 sided||||
1670158|NCT01383161|3073395|Superiority|||||||0.08|||||||mixed-effects general linear model||||
1670159|NCT01383161|3073396|Superiority|||||||0.2|||||||t-test, 2 sided||||
1670160|NCT01383161|3073396|Superiority|||||||0.01|||||||t-test, 2 sided||||
1670161|NCT01383161|3073396|Superiority|||||||0.5|||||||mixed-effects general linear model||||
1670162|NCT01383005|3073413|Superiority or Other||Odds Ratio (OR)|0.996||||0.025|2-Sided|95.0|0.992|0.999|||Regression, Logistic|Degree of freedom is 1 for the independent variable ‘time on LPV/r.’|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 1 presents the risk of a 'mean score <5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with time on treatment with LPV/r QD in the last model of the Wald test.|
1670163|NCT01383005|3073414|Superiority or Other||Odds Ratio (OR)|0.279||||0.072|2-Sided|95.0|0.07|1.118|||Regression, Logistic|Degree of freedom is 1 for the independent variable ‘viral load change from undetectable to undetectable.’|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 2 presents the risk of a 'mean score <5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with a viral load change from 'undetectable to undetectable' in the last model of the Wald test.|
1670164|NCT01383005|3073414|Superiority or Other||Odds Ratio (OR)|0.16||||0.001|2-Sided|95.0|0.052|0.494|||Regression, Logistic|Degree of freedom is 1 for the independent variable ‘viral load change from detectable to undetectable.’|Stepwise procedures forward and backward were used to select variables in the model using entry and exit probabilities of 0.05 and 0.1 respectively. Identical models were obtained by forward and backward selection procedures.|Statistical Analysis 1 presents the risk of a 'mean score <5' on the HIVTSQ overall satisfaction dimension (see Outcome Measure 8) when correlated with a viral load change from 'detectable to undetectable' in the last model of the Wald test.|
1670165|NCT01382719|3073431|Superiority or Other||Mean Difference (Final Values)|0.0133|||<|0.05|||||||ANCOVA||||
1670166|NCT01382719|3073432|Superiority or Other||Mean Difference (Final Values)|0.1161|||<|0.05|||||||Van Elteren||||
1670167|NCT01382719|3073433|Superiority or Other||Mean Difference (Final Values)|0.0013|||<|0.05|||||||Van Elteren||||
1670168|NCT01382719|3073434|Superiority or Other||Mean Difference (Final Values)|0.0012|||<|0.05|||||||Van Elteren||||
1670169|NCT01382719|3073435|Superiority or Other||Mean Difference (Final Values)|0.0079|||<|0.05|2-Sided|95.0|0.0|1.0|||Van Elteren||||
1670170|NCT01382719|3073436|Superiority or Other||Mean Difference (Final Values)|0.0496|||<|0.05|||||||ANCOVA||||
1670171|NCT01382719|3073437|Superiority or Other||Mean Difference (Final Values)|0.0012|Standard Deviation|0.0012|<|0.05|2-Sided|95.0|0.0|0.06|||Van Elteren||||
1670172|NCT01382719|3073437|Superiority or Other||Mean Difference (Final Values)|0.0215|Standard Deviation|2.9|<|0.05|2-Sided|95.0|0.0|1.0|||Van Elteren||||
1670173|NCT01381900|3073497|Superiority or Other||Odds Ratio (OR)|3.29|||||2-Sided|95.0|1.88|5.75|||||||
1670174|NCT01381900|3073497|Superiority or Other||Odds Ratio (OR)|2.55|||||2-Sided|95.0|1.45|4.48|||||||
1670175|NCT01381900|3073498|Superiority or Other||Odds Ratio (OR)|3.99|||||2-Sided|95.0|2.55|6.27|||||||
1670177|NCT01381900|3073499|Superiority or Other||Least-Squares Mean Difference|-2.3|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-2.9|-1.8|||ANCOVA||||
1670178|NCT01381900|3073499|Superiority or Other||Least-Squares Mean Difference|-2.2|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-2.7|-1.6|||ANCOVA||||
1670179|NCT01381900|3073500|Superiority or Other||Least-Squares Mean Difference|-1.43|Standard Error of the Mean|0.173|<|0.001|2-Sided|95.0|-1.769|-1.089|||ANCOVA||||
1670180|NCT01381900|3073500|Superiority or Other||Least-Squares Mean Difference|-1.03|Standard Error of the Mean|0.173|<|0.001|2-Sided|95.0|-1.375|-0.694|||ANCOVA||||
1670181|NCT01381900|3073501|Superiority or Other||Least-Squares Mean Difference|-0.59|Standard Error of the Mean|0.071|<|0.001|2-Sided|95.0|-0.731|-0.453|||ANCOVA||||
1670182|NCT01381900|3073501|Superiority or Other||Least-Squares Mean Difference|-0.51|Standard Error of the Mean|0.071|<|0.001|2-Sided|95.0|-0.644|-0.367|||ANCOVA||||
1670183|NCT01381874|3073505|Superiority||Risk Ratio (RR)|1.79||||0.137|2-Sided|95.0|0.816|3.926|||Chi-squared||||
1670184|NCT01381874|3073505|Superiority||Risk Ratio (RR)|0.757||||0.603|2-Sided|95.0|0.264|2.175|||Chi-squared||||
1670185|NCT01381874|3073506|Superiority||Risk Ratio (RR)|1.909||||0.366|2-Sided|95.0|0.605|6.026|||Fisher Exact||||
1670186|NCT01381874|3073506|Superiority||Risk Ratio (RR)|0.909||||1|2-Sided|95.0|0.213|3.878|||Fisher Exact||||
1670187|NCT01381874|3073507|Superiority||Hazard Ratio (HR)|1.183||||0.542|2-Sided|95.0|0.688|2.036|||stratified log-rank test||||
1670188|NCT01381874|3073507|Superiority||Hazard Ratio (HR)|1.074||||0.807|2-Sided|95.0|0.608|1.896|||stratified log-rank test||||
1670189|NCT01381874|3073508|Superiority||Hazard Ratio (HR)|0.958||||0.794|2-Sided|95.0|0.695|1.32|||stratified log-rank test||||
1670190|NCT01381874|3073508|Superiority||Hazard Ratio (HR)|1.143||||0.437|2-Sided|95.0|0.816|1.603|||stratified log-rank test||||
1670191|NCT01381575|3073548|Non-Inferiority|Non-inferiority with respect to Geometric Mean Concentrations (GMCs) was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of 95% CI for the GMT ratio (Cervarix 2 Group divided by Cervarix 1 Group) was below 2.|Geometric mean ratio|0.85|||||2-Sided|95.0|0.76|0.95||||||Immune response to anti-HPV-18 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.|
1670192|NCT01381575|3073548|Non-Inferiority|Non-inferiority with respect to Geometric Mean Concentrations (GMCs) was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of 95% CI for the GMT ratio (Cervarix 2 Group divided by Cervarix 1 Group) was below 2.|Geometric mean ratio|1.09|||||2-Sided|95.0|0.97|1.22||||||Immune response to anti-HPV-16 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.|
1670193|NCT01381575|3073549|Non-Inferiority|Non-inferiority with respect to seroconversion was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of the 95% Confidence Interval (CI) for the difference (Cervarix 2 Group minus Cervarix 1 Group) was below 5%.|Difference in SCR|0.0|||||2-Sided|95.0|-1.0|0.77||||||Immune response to anti-HPV-18 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.|
1670194|NCT01381575|3073549|Non-Inferiority|Non-inferiority with respect to seroconversion was demonstrated if, 1 month after the last dose, for both anti-HPV-16 and anti-HPV-18, the upper limit of the 95% Confidence Interval (CI) for the difference (Cervarix 2 Group minus Cervarix 1 Group) was below 5%.|Difference in SCR|0.0|||||2-Sided|95.0|-1.08|0.78||||||Immune response to anti-HPV-16 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.|
1670195|NCT01381406|3073607|Superiority or Other||Hazard Ratio (HR)|0.763||||0.013|2-Sided|95.0|0.646|0.949||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Moderate COPD Exacerbations|Regression, Logistic||||
1670196|NCT01381406|3073607|Superiority or Other||Hazard Ratio (HR)|0.622||||0.146|2-Sided|95.0|0.328|1.18||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Severe COPD Exacerbations|Regression, Logistic||||
1670197|NCT01381406|3073607|Superiority or Other||Hazard Ratio (HR)|0.772||||0.007|2-Sided|95.0|0.641|0.93||COPD-Related Adjusted Multivariate Outcomes in the Follow-Up Period by Cohort (reference cohort = TIO) for Any COPD Exacerbation|Regression, Logistic||||
1670198|NCT01380730|3073642|Superiority or Other||LS Mean Treatment Difference|-33.77|Standard Error of the Mean|2.76|<|0.001|2-Sided|95.0|-39.2|-28.33||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670199|NCT01380730|3073642|Superiority or Other||LS Mean Treatment Difference|-42.4|Standard Error of the Mean|2.75|<|0.001|2-Sided|95.0|-47.81|-36.98||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670200|NCT01380730|3073642|Superiority or Other||LS Mean Treatment Difference|-42.93|Standard Error of the Mean|2.76|<|0.001|2-Sided|95.0|-48.36|-37.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670201|NCT01380730|3073642|Superiority or Other||LS Mean Treatment Difference|-34.75|Standard Error of the Mean|2.43|<|0.001|2-Sided|95.0|-39.53|-29.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670202|NCT01380730|3073642|Superiority or Other||LS Mean Treatment Difference|-47.3|Standard Error of the Mean|2.43|<|0.001|2-Sided|95.0|-52.08|-42.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670203|NCT01380730|3073642|Superiority or Other||LS Mean Treatment Difference|-53.44|Standard Error of the Mean|2.44|<|0.001|2-Sided|95.0|-58.23|-48.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670204|NCT01380730|3073643|Superiority or Other||LS Mean Treatment Difference|-27.73|Standard Error of the Mean|2.2|<|0.001|2-Sided|95.0|-32.06|-23.39||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670205|NCT01380730|3073643|Superiority or Other||LS Mean Treatment Difference|-35.97|Standard Error of the Mean|2.2|<|0.001|2-Sided|95.0|-40.29|-31.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670206|NCT01380730|3073643|Superiority or Other||LS Mean Treatment Difference|-35.65|Standard Error of the Mean|2.2|<|0.001|2-Sided|95.0|-39.99|-31.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670207|NCT01380730|3073643|Superiority or Other||LS Mean Treatment Difference|-31.4|Standard Error of the Mean|2.25|<|0.001|2-Sided|95.0|-35.83|-26.97||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670208|NCT01380730|3073643|Superiority or Other||LS Mean Treatment Difference|-43.38|Standard Error of the Mean|2.25|<|0.001|2-Sided|95.0|-47.81|-38.94||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670209|NCT01380730|3073643|Superiority or Other||LS Mean Treatment Difference|-47.74|Standard Error of the Mean|2.26|<|0.001|2-Sided|95.0|-52.18|-43.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670210|NCT01380730|3073644|Superiority or Other||LS Mean Treatment Difference|-34.38|Standard Error of the Mean|2.61|<|0.001|2-Sided|95.0|-39.51|-29.25||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670211|NCT01380730|3073644|Superiority or Other||LS Mean Treatment Difference|-40.77|Standard Error of the Mean|2.6|<|0.001|2-Sided|95.0|-45.88|-35.66||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670212|NCT01380730|3073644|Superiority or Other||LS Mean Treatment Difference|-42.03|Standard Error of the Mean|2.61|<|0.001|2-Sided|95.0|-47.16|-36.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670213|NCT01380730|3073644|Superiority or Other||LS Mean Treatment Difference|-34.74|Standard Error of the Mean|2.45|<|0.001|2-Sided|95.0|-39.56|-29.92||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670214|NCT01380730|3073644|Superiority or Other||LS Mean Treatment Difference|-50.15|Standard Error of the Mean|2.45|<|0.001|2-Sided|95.0|-54.97|-45.33||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670215|NCT01380730|3073644|Superiority or Other||LS Mean Treatment Difference|-56.45|Standard Error of the Mean|2.46|<|0.001|2-Sided|95.0|-61.28|-51.61||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670216|NCT01380730|3073645|Superiority or Other||LS Mean Treatment Difference|-37.79|Standard Error of the Mean|2.61|<|0.001|2-Sided|95.0|-42.94|-32.65||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670217|NCT01380730|3073645|Superiority or Other||LS Mean Treatment Difference|-45.8|Standard Error of the Mean|2.6|<|0.001|2-Sided|95.0|-50.92|-40.67||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670218|NCT01380730|3073645|Superiority or Other||LS Mean Treatment Difference|-47.58|Standard Error of the Mean|2.61|<|0.001|2-Sided|95.0|-52.72|-42.44||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670219|NCT01380730|3073645|Superiority or Other||LS Mean Treatment Difference|-38.44|Standard Error of the Mean|2.52|<|0.001|2-Sided|95.0|-43.39|-33.48||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670220|NCT01380730|3073645|Superiority or Other||LS Mean Treatment Difference|-55.42|Standard Error of the Mean|2.52|<|0.001|2-Sided|95.0|-60.37|-50.47||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670221|NCT01380730|3073645|Superiority or Other||LS Mean Treatment Difference|-61.4|Standard Error of the Mean|2.53|<|0.001|2-Sided|95.0|-66.37|-56.43||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670222|NCT01380730|3073646|Superiority or Other||LS Mean Treatment Difference|-50.6|Standard Error of the Mean|3.8|<|0.001|2-Sided|95.0|-58.0|-43.1||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670223|NCT01380730|3073646|Superiority or Other||LS Mean Treatment Difference|-61.1|Standard Error of the Mean|3.8|<|0.001|2-Sided|95.0|-68.5|-53.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670224|NCT01380730|3073646|Superiority or Other||LS Mean Treatment Difference|-61.1|Standard Error of the Mean|3.8|<|0.001|2-Sided|95.0|-68.6|-53.7||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670225|NCT01380730|3073646|Superiority or Other||LS Mean Treatment Difference|-50.7|Standard Error of the Mean|4.0|<|0.001|2-Sided|95.0|-58.5|-43.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670226|NCT01380730|3073646|Superiority or Other||LS Mean Treatment Difference|-77.4|Standard Error of the Mean|4.0|<|0.001|2-Sided|95.0|-85.2|-69.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670227|NCT01380730|3073646|Superiority or Other||LS Mean Treatment Difference|-79.2|Standard Error of the Mean|4.0|<|0.001|2-Sided|95.0|-87.0|-71.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference||
1670228|NCT01380730|3073647|Superiority or Other||LS Mean Treatment Difference|-41.84|Standard Error of the Mean|2.9|<|0.001|2-Sided|95.0|-47.55|-36.13||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1670229|NCT01380730|3073647|Superiority or Other||LS Mean Treatment Difference|-50.0|Standard Error of the Mean|2.89|<|0.001|2-Sided|95.0|-55.69|-44.31||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1670230|NCT01380730|3073647|Superiority or Other||LS Mean Treatment Difference|-50.33|Standard Error of the Mean|2.9|<|0.001|2-Sided|95.0|-56.04|-44.62||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1670231|NCT01380730|3073647|Superiority or Other||LS Mean Treatment Difference|-41.82|Standard Error of the Mean|2.73|<|0.001|2-Sided|95.0|-47.18|-36.45||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1670232|NCT01380730|3073647|Superiority or Other||LS Mean Treatment Difference|-60.24|Standard Error of the Mean|2.73|<|0.001|2-Sided|95.0|-65.61|-54.88||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1670233|NCT01380730|3073647|Superiority or Other||LS Mean Treatment Difference|-66.1|Standard Error of the Mean|2.73|<|0.001|2-Sided|95.0|-71.48|-60.72||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and stratification factors.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1670234|NCT01380535|3073669|Other|||||||0.373|||||||Fisher Exact||||
1670235|NCT01380379|3073670|Superiority or Other||||||<|0.04|||||||t-test, 2 sided||||
1670236|NCT01380379|3073671|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|Single group comparison pre-post change score, compared to a value of 0 (no change)|||
1670237|NCT01380327|3073675|Superiority or Other||Treatment effect|13.5||||0.2|2-Sided|95.0|-7.1|34.1|||Mixed Models Analysis||Estimated value& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (19.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .|Analysis compared cockroach SLIT - low dose, placebo - low dose|
1670238|NCT01380327|3073675|Superiority or Other||Treatment effect|-12.9||||0.21|2-Sided|95.0|-33.2|7.5|||Mixed Models Analysis||Estimated value& associated CI is the treatment effect: baseline to post-baseline change in measurement in high dose group (-7.2) minus baseline to post-baseline change in measurement in placebo group (5.7) .|Analysis compared cockroach SLIT - high dose, placebo - high dose|
1670239|NCT01380327|3073676|Superiority or Other||Risk Ratio (RR)|1.4||||0.13|2-Sided|95.0|0.9|2.2|||Mixed Models Analysis||Estimated value & associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. low dose group (numerator=1.45).|Analysis compared cockroach SLIT - low dose, placebo - low dose|
1670240|NCT01380327|3073676|Superiority or Other||Risk Ratio (RR)|1.5||||0.06|2-Sided|95.0|1.0|2.4|||Mixed Models Analysis||Estimated value and associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.03) vs. high dose group (numerator=1.57).|Analysis compared cockroach SLIT - high dose, placebo - high dose|
1670241|NCT01380327|3073677|Superiority or Other||Risk Ratio (RR)|1.1||||0.11|2-Sided|95.0|1.0|1.2|||Mixed Models Analysis||Estimated value & associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. low dose group (numerator=1.14).|Analysis compared cockroach SLIT - low dose, placebo - low dose|
1670242|NCT01380327|3073677|Superiority or Other||Risk Ratio (RR)|1.3|||<|0.0001|2-Sided|95.0|1.1|1.4|||Mixed Models Analysis||Estimated value & associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.04) vs. high dose group (numerator=1.32).|Analysis compared cockroach SLIT - high dose, placebo - high dose|
1670243|NCT01380327|3073678|Superiority or Other||Risk Ratio (RR)|2.3|||<|0.0001|2-Sided|95.0|1.7|3.1|||Mixed Models Analysis||Estimated value & associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. low dose group (numerator=2.69).|Analysis compared cockroach SLIT - low dose, placebo - low dose|
1670244|NCT01380327|3073678|Superiority or Other||Risk Ratio (RR)|1.7|||<|0.001|2-Sided|95.0|1.2|2.3|||Mixed Models Analysis||Estimated value & associated CI is the ratio of change (baseline to post-baseline) in placebo group (denominator=1.18) vs. high dose group (numerator=1.98).|Analysis compared cockroach SLIT -high dose, Placebo - high dose|
1670538|NCT01378065|3074028|Superiority or Other (legacy)||||||<|0.001|||||||t-test, 2 sided||||
1670245|NCT01380093|3073712|Superiority or Other||Geometric mean ratio|1.32||||0.0005|2-Sided|90.0|1.17|1.49|||Mixed Models Analysis|||Natural log transformed AUC (0-∞) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670246|NCT01380093|3073713|Superiority or Other||Geometric mean ratio|1.1||||0.0204|2-Sided|90.0|1.03|1.18|||Mixed Models Analysis|||Natural log transformed AUC (0-24) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670247|NCT01380093|3073714|Superiority or Other||Geometric mean ratio|1.03||||0.425|2-Sided|90.0|0.97|1.1|||Mixed Models Analysis|||Natural log transformed AUC (0-12) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670248|NCT01380093|3073715|Superiority or Other||Geometric mean ratio|1.0||||0.9057|2-Sided|90.0|0.94|1.08|||Mixed Models Analysis|||Natural log transformed AUC (0-8) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670249|NCT01380093|3073716|Superiority or Other||Geometric mean ratio|0.98||||0.6399|2-Sided|90.0|0.91|1.06|||Mixed Models Analysis|||Natural log transformed AUC (0-4) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670250|NCT01380093|3073717|Superiority or Other||Geometric mean ratio|0.86||||0.0065|2-Sided|90.0|0.79|0.94|||Mixed Models Analysis|||Natural log transformed AUC (0-2) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670251|NCT01380093|3073718|Superiority or Other||Geometric mean ratio|0.77||||0.0004|2-Sided|90.0|0.69|0.86|||Mixed Models Analysis|||Natural log transformed AUC (0-1) was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670252|NCT01380093|3073719|Superiority or Other||Geometric mean ratio|0.75|||<|0.0001|2-Sided|90.0|0.68|0.83|||Mixed Models Analysis|||Natural log transformed Cmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670253|NCT01380093|3073720|Superiority or Other||LS Mean Difference|0.21||||0.0181|2-Sided|90.0|0.07|0.35|||Mixed Models Analysis|||Tmax was analyzed using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670254|NCT01380093|3073721|Superiority or Other||LS Mean Difference|-1.6||||0.1479|2-Sided|95.0|-3.7|0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670255|NCT01380093|3073721|Superiority or Other||LS Mean Difference|0.9||||0.418|2-Sided|95.0|-1.3|3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670256|NCT01380093|3073721|Superiority or Other||LS Mean Difference|2.5||||0.0262|2-Sided|95.0|0.3|4.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670257|NCT01380093|3073722|Superiority or Other||LS Mean Difference|-2.9|||<|0.0001|2-Sided|95.0|-3.2|-2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670258|NCT01380093|3073722|Superiority or Other||LS Mean Difference|-1.8|||<|0.0001|2-Sided|95.0|-2.1|-1.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670259|NCT01380093|3073722|Superiority or Other||LS Mean Difference|1.1|||<|0.0001|2-Sided|95.0|0.8|1.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670260|NCT01380093|3073723|Superiority or Other||LS Mean Difference|-55.2|||<|0.0001|2-Sided|95.0|-61.1|-49.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670261|NCT01380093|3073723|Superiority or Other||LS Mean Difference|-37.7|||<|0.0001|2-Sided|95.0|-43.6|-31.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670262|NCT01380093|3073723|Superiority or Other||LS Mean Difference|17.5|||<|0.0001|2-Sided|95.0|11.6|23.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670263|NCT01380093|3073724|Superiority or Other||LS Mean Difference|-33.2|||<|0.0001|2-Sided|95.0|-36.2|-30.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670264|NCT01380093|3073724|Superiority or Other||LS Mean Difference|-21.5|||<|0.0001|2-Sided|95.0|-24.5|-18.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670265|NCT01380093|3073724|Superiority or Other||LS Mean Difference|11.7|||<|0.0001|2-Sided|95.0|8.7|14.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670266|NCT01380093|3073725|Superiority or Other||LS Mean Difference|-22.4|||<|0.0001|2-Sided|95.0|-24.5|-20.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1671587|NCT01362062|3075953|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.|
1670267|NCT01380093|3073725|Superiority or Other||LS Mean Difference|-13.8|||<|0.0001|2-Sided|95.0|-15.9|-11.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670268|NCT01380093|3073725|Superiority or Other||LS Mean Difference|8.6|||<|0.0001|2-Sided|95.0|6.6|10.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670269|NCT01380093|3073726|Superiority or Other||LS Mean Difference|-10.1|||<|0.0001|2-Sided|95.0|-11.1|-9.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670270|NCT01380093|3073726|Superiority or Other||LS Mean Difference|-5.3|||<|0.0001|2-Sided|95.0|-6.3|-4.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670271|NCT01380093|3073726|Superiority or Other||LS Mean Difference|4.9|||<|0.0001|2-Sided|95.0|3.9|5.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670272|NCT01380093|3073727|Superiority or Other||LS Mean Difference|-4.1|||<|0.0001|2-Sided|95.0|-4.6|-3.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670273|NCT01380093|3073727|Superiority or Other||LS Mean Difference|-1.7|||<|0.0001|2-Sided|95.0|-2.2|-1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670274|NCT01380093|3073727|Superiority or Other||LS Mean Difference|2.4|||<|0.0001|2-Sided|95.0|1.9|2.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670275|NCT01380093|3073728|Superiority or Other||LS Mean Difference|-1.2|||<|0.0001|2-Sided|95.0|-1.5|-1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670276|NCT01380093|3073728|Superiority or Other||LS Mean Difference|-0.5|||<|0.0001|2-Sided|95.0|-0.8|-0.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670277|NCT01380093|3073728|Superiority or Other||LS Mean Difference|0.7|||<|0.0001|2-Sided|95.0|0.5|0.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670278|NCT01380093|3073729|Superiority or Other||LS Mean Difference|21.2|||<|0.0001|2-Sided|95.0|12.0|30.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670279|NCT01380093|3073729|Superiority or Other||LS Mean Difference|8.2|||<|0.07|2-Sided|95.0|-1.0|17.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670280|NCT01380093|3073729|Superiority or Other||LS Mean Difference|-13.0|||<|0.005|2-Sided|95.0|-22.0|-4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670281|NCT01380093|3073730|Superiority or Other||LS Mean Difference|19.3|||<|0.0001|2-Sided|95.0|12.0|27.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670282|NCT01380093|3073730|Superiority or Other||LS Mean Difference|8.1|||<|0.0286|2-Sided|95.0|1.0|15.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670283|NCT01380093|3073730|Superiority or Other||LS Mean Difference|-11.2|||<|0.0029|2-Sided|95.0|-18.0|-4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670284|NCT01380093|3073731|Superiority or Other||LS Mean Difference|1.9||||0.0002|2-Sided|95.0|1.0|2.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670285|NCT01380093|3073731|Superiority or Other||LS Mean Difference|1.5||||0.0023|2-Sided|95.0|0.6|2.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670286|NCT01380093|3073731|Superiority or Other||LS Mean Difference|-0.4||||0.3986|2-Sided|95.0|-1.4|0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670287|NCT01380093|3073732|Superiority or Other||LS Mean Difference|12.8|||<|0.0001|2-Sided|95.0|7.9|17.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670288|NCT01380093|3073732|Superiority or Other||LS Mean Difference|4.8|||<|0.0527|2-Sided|95.0|-0.1|9.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670289|NCT01380093|3073732|Superiority or Other||LS Mean Difference|-8.0|||<|0.0018|2-Sided|95.0|-12.9|-3.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670290|NCT01380093|3073733|Superiority or Other||LS Mean Difference|81.3|||<|0.0001|2-Sided|95.0|45.4|117.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670291|NCT01380093|3073733|Superiority or Other||LS Mean Difference|32.3|||<|0.0766|2-Sided|95.0|-3.5|68.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670292|NCT01380093|3073733|Superiority or Other||LS Mean Difference|-49.0|||<|0.0083|2-Sided|95.0|-85.0|-13.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670293|NCT01380093|3073734|Superiority or Other||LS Mean Difference|68.6|||<|0.0001|2-Sided|95.0|38.8|98.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670294|NCT01380093|3073734|Superiority or Other||LS Mean Difference|25.3|||<|0.0941|2-Sided|95.0|-4.4|55.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670295|NCT01380093|3073734|Superiority or Other||LS Mean Difference|-43.3|||<|0.0051|2-Sided|95.0|-73.1|-13.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670296|NCT01380093|3073735|Superiority or Other||LS Mean Difference|54.4|||<|0.0001|2-Sided|95.0|31.0|77.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670297|NCT01380093|3073735|Superiority or Other||LS Mean Difference|19.3|||<|0.1026|2-Sided|95.0|-4.0|42.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670298|NCT01380093|3073735|Superiority or Other||LS Mean Difference|-35.1|||<|0.0039|2-Sided|95.0|-58.5|-11.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670299|NCT01380093|3073736|Superiority or Other||LS Mean Difference|62.1|||<|0.0001|2-Sided|95.0|54.9|69.4||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670300|NCT01380093|3073736|Superiority or Other||LS Mean Difference|27.2|||<|0.0001|2-Sided|95.0|20.1|34.4||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670301|NCT01380093|3073736|Superiority or Other||LS Mean Difference|-34.9|||<|0.0001|2-Sided|95.0|-42.1|-27.7||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670302|NCT01380093|3073737|Superiority or Other||LS Mean Difference|25.0|||<|0.0001|2-Sided|95.0|14.1|35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670303|NCT01380093|3073737|Superiority or Other||LS Mean Difference|8.7|||<|0.1139|2-Sided|95.0|-2.2|19.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670304|NCT01380093|3073737|Superiority or Other||LS Mean Difference|-16.2|||<|0.0042|2-Sided|95.0|-27.2|-5.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670305|NCT01380093|3073738|Superiority or Other||LS Mean Difference|9.3|||<|0.0001|2-Sided|95.0|5.3|13.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670306|NCT01380093|3073738|Superiority or Other||LS Mean Difference|2.2|||<|0.2693|2-Sided|95.0|-1.8|6.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670307|NCT01380093|3073738|Superiority or Other||LS Mean Difference|-7.0|||<|0.0009|2-Sided|95.0|-11.1|-3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670308|NCT01380093|3073739|Superiority or Other||LS Mean Difference|2.7||||0.0008|2-Sided|95.0|1.1|4.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670309|NCT01380093|3073739|Superiority or Other||LS Mean Difference|0.5||||0.4998|2-Sided|95.0|-1.0|2.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1672135|NCT01355523|3076607|Superiority or Other|||||||0.555|||||||Wilcoxon (Mann-Whitney)||||
1670310|NCT01380093|3073739|Superiority or Other||LS Mean Difference|-2.1||||0.0062|2-Sided|95.0|-3.7|-0.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670311|NCT01380093|3073740|Superiority or Other||LS Mean Difference|4.2|||<|0.0001|2-Sided|95.0|3.0|5.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670312|NCT01380093|3073740|Superiority or Other||LS Mean Difference|2.8|||<|0.0001|2-Sided|95.0|1.6|4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670313|NCT01380093|3073740|Superiority or Other||LS Mean Difference|-1.4|||<|0.0253|2-Sided|95.0|-2.6|-0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670314|NCT01380093|3073741|Superiority or Other||LS Mean Difference|42.1|||<|0.0001|2-Sided|95.0|34.7|49.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670315|NCT01380093|3073741|Superiority or Other||LS Mean Difference|25.7|||<|0.0001|2-Sided|95.0|18.3|33.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670316|NCT01380093|3073741|Superiority or Other||LS Mean Difference|-16.4|||<|0.0001|2-Sided|95.0|-23.8|-9.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670317|NCT01380093|3073742|Superiority or Other||LS Mean Difference|370.5|||<|0.0001|2-Sided|95.0|292.7|448.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670318|NCT01380093|3073742|Superiority or Other||LS Mean Difference|169.1|||<|0.0001|2-Sided|95.0|91.5|246.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670319|NCT01380093|3073742|Superiority or Other||LS Mean Difference|-201.4|||<|0.0001|2-Sided|95.0|-279.3|-123.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670320|NCT01380093|3073743|Superiority or Other||LS Mean Difference|281.5|||<|0.0001|2-Sided|95.0|223.7|339.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670321|NCT01380093|3073743|Superiority or Other||LS Mean Difference|134.1|||<|0.0001|2-Sided|95.0|76.5|191.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670322|NCT01380093|3073743|Superiority or Other||LS Mean Difference|-147.4|||<|0.0001|2-Sided|95.0|-205.1|-89.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670323|NCT01380093|3073744|Superiority or Other||LS Mean Difference|194.2|||<|0.0001|2-Sided|95.0|152.3|236.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670324|NCT01380093|3073744|Superiority or Other||LS Mean Difference|93.9|||<|0.0001|2-Sided|95.0|52.1|135.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670325|NCT01380093|3073744|Superiority or Other||LS Mean Difference|-100.3|||<|0.0001|2-Sided|95.0|-142.2|-58.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670326|NCT01380093|3073745|Superiority or Other||LS Mean Difference|72.6|||<|0.0001|2-Sided|95.0|55.2|90.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670327|NCT01380093|3073745|Superiority or Other||LS Mean Difference|34.4|||<|0.0002|2-Sided|95.0|17.0|51.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670328|NCT01380093|3073745|Superiority or Other||LS Mean Difference|-38.2|||<|0.0001|2-Sided|95.0|-55.6|-20.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670329|NCT01380093|3073746|Superiority or Other||LS Mean Difference|20.6|||<|0.0001|2-Sided|95.0|14.4|26.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670330|NCT01380093|3073746|Superiority or Other||LS Mean Difference|8.4|||<|0.0081|2-Sided|95.0|2.3|14.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670331|NCT01380093|3073746|Superiority or Other||LS Mean Difference|-12.2|||<|0.0002|2-Sided|95.0|-18.4|-6.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670332|NCT01380093|3073747|Superiority or Other||LS Mean Difference|3.3||||0.0011|2-Sided|95.0|1.4|5.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670333|NCT01380093|3073747|Superiority or Other||LS Mean Difference|2.1||||0.0345|2-Sided|95.0|0.2|4.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670334|NCT01380093|3073747|Superiority or Other||LS Mean Difference|-1.2||||0.2117|2-Sided|95.0|-3.1|0.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670335|NCT01380093|3073748|Superiority or Other||LS Mean Difference|3.4|||<|0.0001|2-Sided|95.0|2.1|4.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670336|NCT01380093|3073748|Superiority or Other||LS Mean Difference|1.0|||<|0.1631|2-Sided|95.0|-0.4|2.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670337|NCT01380093|3073748|Superiority or Other||LS Mean Difference|-2.5|||<|0.0007|2-Sided|95.0|-3.8|-1.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670338|NCT01380093|3073749|Superiority or Other||LS Mean Difference|15.9|||<|0.0001|2-Sided|95.0|11.1|20.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670339|NCT01380093|3073749|Superiority or Other||LS Mean Difference|4.2|||<|0.0811|2-Sided|95.0|-0.5|8.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670340|NCT01380093|3073749|Superiority or Other||LS Mean Difference|-11.7|||<|0.0001|2-Sided|95.0|-16.4|-7.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670341|NCT01380093|3073750|Superiority or Other||LS Mean Difference|111.4|||<|0.0001|2-Sided|95.0|70.6|152.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670342|NCT01380093|3073750|Superiority or Other||LS Mean Difference|27.4|||<|0.1826|2-Sided|95.0|-13.3|68.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670343|NCT01380093|3073750|Superiority or Other||LS Mean Difference|-84.0|||<|0.0001|2-Sided|95.0|-124.8|-43.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670344|NCT01380093|3073751|Superiority or Other||LS Mean Difference|80.4|||<|0.0001|2-Sided|95.0|52.0|108.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670345|NCT01380093|3073751|Superiority or Other||LS Mean Difference|20.4|||<|0.1556|2-Sided|95.0|-8.0|48.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670346|NCT01380093|3073751|Superiority or Other||LS Mean Difference|-60.1|||<|0.0001|2-Sided|95.0|-88.5|-31.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670347|NCT01380093|3073752|Superiority or Other||LS Mean Difference|49.9|||<|0.0001|2-Sided|95.0|31.8|67.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670348|NCT01380093|3073752|Superiority or Other||LS Mean Difference|13.2|||<|0.1488|2-Sided|95.0|-4.8|31.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670349|NCT01380093|3073752|Superiority or Other||LS Mean Difference|-36.7|||<|0.0001|2-Sided|95.0|-54.8|-18.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670350|NCT01380093|3073753|Superiority or Other||LS Mean Difference|15.1||||0.0002|2-Sided|95.0|7.5|22.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670351|NCT01380093|3073753|Superiority or Other||LS Mean Difference|4.2||||0.28|2-Sided|95.0|-3.5|11.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670352|NCT01380093|3073753|Superiority or Other||LS Mean Difference|-11.0||||0.0059|2-Sided|95.0|-18.7|-3.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670353|NCT01380093|3073754|Superiority or Other||LS Mean Difference|3.6||||0.0121|2-Sided|95.0|0.8|6.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670354|NCT01380093|3073754|Superiority or Other||LS Mean Difference|1.1||||0.4515|2-Sided|95.0|-1.7|3.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670355|NCT01380093|3073754|Superiority or Other||LS Mean Difference|-2.6||||0.0723|2-Sided|95.0|-5.3|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670356|NCT01380093|3073755|Superiority or Other||LS Mean Difference|0.7||||0.1266|2-Sided|95.0|-0.2|1.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670357|NCT01380093|3073755|Superiority or Other||LS Mean Difference|0.0||||0.9421|2-Sided|95.0|-1.0|0.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670358|NCT01380093|3073755|Superiority or Other||LS Mean Difference|-0.8||||0.11|2-Sided|95.0|-1.7|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670359|NCT01380093|3073756|Superiority or Other||LS Mean Difference|2.9||||0.0056|2-Sided|95.0|0.9|5.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670360|NCT01380093|3073756|Superiority or Other||LS Mean Difference|1.1||||0.2769|2-Sided|95.0|-0.9|3.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670361|NCT01380093|3073756|Superiority or Other||LS Mean Difference|-1.8||||0.0806|2-Sided|95.0|-3.8|0.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670362|NCT01380093|3073757|Superiority or Other||LS Mean Difference|14.3|||<|0.0001|2-Sided|95.0|9.9|18.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670363|NCT01380093|3073757|Superiority or Other||LS Mean Difference|4.3|||<|0.0529|2-Sided|95.0|-0.1|8.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670364|NCT01380093|3073757|Superiority or Other||LS Mean Difference|-10.0|||<|0.0001|2-Sided|95.0|-14.4|-5.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670365|NCT01380093|3073758|Superiority or Other||LS Mean Difference|107.7|||<|0.0001|2-Sided|95.0|64.9|150.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670366|NCT01380093|3073758|Superiority or Other||LS Mean Difference|31.8|||<|0.141|2-Sided|95.0|-10.8|74.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670367|NCT01380093|3073758|Superiority or Other||LS Mean Difference|-75.8|||<|0.0008|2-Sided|95.0|-118.6|-33.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670368|NCT01380093|3073759|Superiority or Other||LS Mean Difference|76.8|||<|0.0001|2-Sided|95.0|47.3|106.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670369|NCT01380093|3073759|Superiority or Other||LS Mean Difference|23.2|||<|0.1207|2-Sided|95.0|-6.3|52.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670370|NCT01380093|3073759|Superiority or Other||LS Mean Difference|-53.6|||<|0.0006|2-Sided|95.0|-83.2|-24.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670371|NCT01380093|3073760|Superiority or Other||LS Mean Difference|46.5|||<|0.0001|2-Sided|95.0|27.8|65.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670372|NCT01380093|3073760|Superiority or Other||LS Mean Difference|14.9|||<|0.1136|2-Sided|95.0|-3.7|33.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670373|NCT01380093|3073760|Superiority or Other||LS Mean Difference|-31.5|||<|0.0013|2-Sided|95.0|-50.2|-12.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670374|NCT01380093|3073761|Superiority or Other||LS Mean Difference|14.4|||<|0.0001|2-Sided|95.0|7.5|21.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670375|NCT01380093|3073761|Superiority or Other||LS Mean Difference|4.5|||<|0.1918|2-Sided|95.0|-2.3|11.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670376|NCT01380093|3073761|Superiority or Other||LS Mean Difference|-9.8|||<|0.0057|2-Sided|95.0|-16.7|-3.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670377|NCT01380093|3073762|Superiority or Other||LS Mean Difference|3.1||||0.0057|2-Sided|95.0|0.9|5.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670378|NCT01380093|3073762|Superiority or Other||LS Mean Difference|1.4||||0.1997|2-Sided|95.0|-0.7|3.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670379|NCT01380093|3073762|Superiority or Other||LS Mean Difference|-1.7||||0.1211|2-Sided|95.0|-3.8|0.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670380|NCT01380093|3073763|Superiority or Other||LS Mean Difference|0.4||||0.2524|2-Sided|95.0|-0.3|1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670381|NCT01380093|3073763|Superiority or Other||LS Mean Difference|0.1||||0.7939|2-Sided|95.0|-0.5|0.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670382|NCT01380093|3073763|Superiority or Other||LS Mean Difference|-0.3||||0.3749|2-Sided|95.0|-0.9|0.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670383|NCT01380093|3073764|Superiority or Other||LS Mean Difference|3.6|||<|0.0001|2-Sided|95.0|2.3|4.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670384|NCT01380093|3073764|Superiority or Other||LS Mean Difference|1.3|||<|0.0455|2-Sided|95.0|0.0|2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670385|NCT01380093|3073764|Superiority or Other||LS Mean Difference|-2.3|||<|0.0007|2-Sided|95.0|-3.6|-1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670386|NCT01380093|3073765|Superiority or Other||LS Mean Difference|19.7|||<|0.0001|2-Sided|95.0|14.6|24.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670387|NCT01380093|3073765|Superiority or Other||LS Mean Difference|6.0|||<|0.0215|2-Sided|95.0|0.9|11.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670388|NCT01380093|3073765|Superiority or Other||LS Mean Difference|-13.7|||<|0.0001|2-Sided|95.0|-18.8|-8.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670389|NCT01380093|3073766|Superiority or Other||LS Mean Difference|145.8|||<|0.0001|2-Sided|95.0|104.1|187.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670390|NCT01380093|3073766|Superiority or Other||LS Mean Difference|33.9|||<|0.1089|2-Sided|95.0|-7.8|75.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670391|NCT01380093|3073766|Superiority or Other||LS Mean Difference|-111.9|||<|0.0001|2-Sided|95.0|-153.7|-70.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670392|NCT01380093|3073767|Superiority or Other||LS Mean Difference|109.7|||<|0.0001|2-Sided|95.0|79.6|139.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670393|NCT01380093|3073767|Superiority or Other||LS Mean Difference|26.9|||<|0.078|2-Sided|95.0|-3.1|56.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670394|NCT01380093|3073767|Superiority or Other||LS Mean Difference|-82.8|||<|0.0001|2-Sided|95.0|-112.9|-52.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670395|NCT01380093|3073768|Superiority or Other||LS Mean Difference|73.6|||<|0.0001|2-Sided|95.0|52.9|94.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670396|NCT01380093|3073768|Superiority or Other||LS Mean Difference|18.5|||<|0.0796|2-Sided|95.0|-2.2|39.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670397|NCT01380093|3073768|Superiority or Other||LS Mean Difference|-55.2|||<|0.0001|2-Sided|95.0|-75.9|-34.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670398|NCT01380093|3073769|Superiority or Other||LS Mean Difference|26.2|||<|0.0001|2-Sided|95.0|16.8|35.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670399|NCT01380093|3073769|Superiority or Other||LS Mean Difference|6.9|||<|0.151|2-Sided|95.0|-2.6|16.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670400|NCT01380093|3073769|Superiority or Other||LS Mean Difference|-19.4|||<|0.0001|2-Sided|95.0|-28.8|-9.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670401|NCT01380093|3073770|Superiority or Other||LS Mean Difference|7.0|||<|0.0001|2-Sided|95.0|3.7|10.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670402|NCT01380093|3073770|Superiority or Other||LS Mean Difference|2.1|||<|0.2178|2-Sided|95.0|-1.2|5.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670403|NCT01380093|3073770|Superiority or Other||LS Mean Difference|-4.9|||<|0.0041|2-Sided|95.0|-8.2|-1.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670404|NCT01380093|3073771|Superiority or Other||LS Mean Difference|1.3||||0.011|2-Sided|95.0|0.3|2.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670405|NCT01380093|3073771|Superiority or Other||LS Mean Difference|0.3||||0.5637|2-Sided|95.0|-0.7|1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670406|NCT01380093|3073771|Superiority or Other||LS Mean Difference|-1.0||||0.0453|2-Sided|95.0|-2.0|0.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670407|NCT01380093|3073772|Superiority or Other||LS Mean Difference|2.0|||<|0.0001|2-Sided|95.0|1.1|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670408|NCT01380093|3073772|Superiority or Other||LS Mean Difference|2.4|||<|0.0001|2-Sided|95.0|1.5|3.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670409|NCT01380093|3073772|Superiority or Other||LS Mean Difference|0.4|||<|0.3345|2-Sided|95.0|-0.4|1.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670410|NCT01380093|3073773|Superiority or Other||LS Mean Difference|60.4|||<|0.0001|2-Sided|95.0|53.4|67.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670411|NCT01380093|3073773|Superiority or Other||LS Mean Difference|26.7|||<|0.0001|2-Sided|95.0|19.7|33.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670412|NCT01380093|3073773|Superiority or Other||LS Mean Difference|-33.8|||<|0.0001|2-Sided|95.0|-40.7|-26.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670413|NCT01380093|3073774|Superiority or Other||LS Mean Difference|501.6|||<|0.0001|2-Sided|95.0|442.2|561.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670414|NCT01380093|3073774|Superiority or Other||LS Mean Difference|165.6|||<|0.0001|2-Sided|95.0|106.4|224.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670415|NCT01380093|3073774|Superiority or Other||LS Mean Difference|-336.0|||<|0.0001|2-Sided|95.0|-395.4|-276.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670416|NCT01380093|3073775|Superiority or Other||LS Mean Difference|415.2|||<|0.0001|2-Sided|95.0|370.2|460.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670417|NCT01380093|3073775|Superiority or Other||LS Mean Difference|147.0|||<|0.0001|2-Sided|95.0|102.1|191.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670418|NCT01380093|3073775|Superiority or Other||LS Mean Difference|-268.2|||<|0.0001|2-Sided|95.0|-313.2|-223.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670419|NCT01380093|3073776|Superiority or Other||LS Mean Difference|325.8|||<|0.0001|2-Sided|95.0|290.8|360.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670420|NCT01380093|3073776|Superiority or Other||LS Mean Difference|118.7|||<|0.0001|2-Sided|95.0|83.9|153.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670421|NCT01380093|3073776|Superiority or Other||LS Mean Difference|-207.0|||<|0.0001|2-Sided|95.0|-242.0|-172.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670422|NCT01380093|3073777|Superiority or Other||LS Mean Difference|169.2|||<|0.0001|2-Sided|95.0|148.9|189.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670423|NCT01380093|3073777|Superiority or Other||LS Mean Difference|60.1|||<|0.0001|2-Sided|95.0|39.9|80.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670424|NCT01380093|3073777|Superiority or Other||LS Mean Difference|-109.1|||<|0.0001|2-Sided|95.0|-129.3|-88.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670425|NCT01380093|3073778|Superiority or Other||LS Mean Difference|69.8|||<|0.0001|2-Sided|95.0|59.9|79.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670426|NCT01380093|3073778|Superiority or Other||LS Mean Difference|24.5|||<|0.0001|2-Sided|95.0|14.6|34.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670427|NCT01380093|3073778|Superiority or Other||LS Mean Difference|-45.3|||<|0.0001|2-Sided|95.0|-55.3|-35.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670428|NCT01380093|3073779|Superiority or Other||LS Mean Difference|21.8|||<|0.0001|2-Sided|95.0|17.8|25.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670429|NCT01380093|3073779|Superiority or Other||LS Mean Difference|8.8|||<|0.0001|2-Sided|95.0|4.8|12.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670430|NCT01380093|3073779|Superiority or Other||LS Mean Difference|-13.0|||<|0.0001|2-Sided|95.0|-17.0|-9.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670431|NCT01380093|3073780|Superiority or Other||LS Mean Difference|1.9|||<|0.0001|2-Sided|95.0|1.0|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670432|NCT01380093|3073780|Superiority or Other||LS Mean Difference|1.8|||<|0.0001|2-Sided|95.0|0.9|2.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670433|NCT01380093|3073780|Superiority or Other||LS Mean Difference|-0.1|||<|0.8671|2-Sided|95.0|-1.0|0.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670434|NCT01380093|3073781|Superiority or Other||LS Mean Difference|61.3|||<|0.0001|2-Sided|95.0|53.1|69.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670435|NCT01380093|3073781|Superiority or Other||LS Mean Difference|30.8|||<|0.0001|2-Sided|95.0|22.6|39.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670436|NCT01380093|3073781|Superiority or Other||LS Mean Difference|-30.5|||<|0.0001|2-Sided|95.0|-38.7|-22.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670437|NCT01380093|3073782|Superiority or Other||LS Mean Difference|495.1|||<|0.0001|2-Sided|95.0|420.6|569.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670438|NCT01380093|3073782|Superiority or Other||LS Mean Difference|185.2|||<|0.0001|2-Sided|95.0|110.8|259.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670439|NCT01380093|3073782|Superiority or Other||LS Mean Difference|-310.0|||<|0.0001|2-Sided|95.0|-384.5|-235.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670440|NCT01380093|3073783|Superiority or Other||LS Mean Difference|411.4|||<|0.0001|2-Sided|95.0|354.3|468.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670441|NCT01380093|3073783|Superiority or Other||LS Mean Difference|166.5|||<|0.0001|2-Sided|95.0|109.5|223.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670442|NCT01380093|3073783|Superiority or Other||LS Mean Difference|-244.9|||<|0.0001|2-Sided|95.0|-302.0|-187.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670443|NCT01380093|3073784|Superiority or Other||LS Mean Difference|325.5|||<|0.0001|2-Sided|95.0|282.1|368.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670444|NCT01380093|3073784|Superiority or Other||LS Mean Difference|134.7|||<|0.0001|2-Sided|95.0|91.5|178.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670445|NCT01380093|3073784|Superiority or Other||LS Mean Difference|-190.8|||<|0.0001|2-Sided|95.0|-234.2|-147.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670446|NCT01380093|3073785|Superiority or Other||LS Mean Difference|176.3|||<|0.0001|2-Sided|95.0|152.6|199.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670447|NCT01380093|3073785|Superiority or Other||LS Mean Difference|67.0|||<|0.0001|2-Sided|95.0|43.5|90.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670448|NCT01380093|3073785|Superiority or Other||LS Mean Difference|-109.3|||<|0.0001|2-Sided|95.0|-132.9|-85.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670449|NCT01380093|3073786|Superiority or Other||LS Mean Difference|76.0|||<|0.0001|2-Sided|95.0|64.2|87.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670450|NCT01380093|3073786|Superiority or Other||LS Mean Difference|28.3|||<|0.0001|2-Sided|95.0|16.5|40.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670451|NCT01380093|3073786|Superiority or Other||LS Mean Difference|-47.7|||<|0.0001|2-Sided|95.0|-59.5|-35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670452|NCT01380093|3073787|Superiority or Other||LS Mean Difference|26.5|||<|0.0001|2-Sided|95.0|21.5|31.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670453|NCT01380093|3073787|Superiority or Other||LS Mean Difference|11.2|||<|0.0001|2-Sided|95.0|6.3|16.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670454|NCT01380093|3073787|Superiority or Other||LS Mean Difference|-15.3|||<|0.0001|2-Sided|95.0|-20.3|-10.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670455|NCT01380093|3073788|Superiority or Other||LS Mean Difference|1.8|||<|0.0001|2-Sided|95.0|1.0|2.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670456|NCT01380093|3073788|Superiority or Other||LS Mean Difference|2.0|||<|0.0001|2-Sided|95.0|1.2|2.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670457|NCT01380093|3073788|Superiority or Other||LS Mean Difference|0.2|||<|0.5607|2-Sided|95.0|-0.6|1.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670458|NCT01380093|3073789|Superiority or Other||LS Mean Difference|475.4|||<|0.0001|2-Sided|95.0|411.3|539.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670459|NCT01380093|3073789|Superiority or Other||LS Mean Difference|168.6|||<|0.0001|2-Sided|95.0|104.7|232.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670460|NCT01380093|3073789|Superiority or Other||LS Mean Difference|-306.8|||<|0.0001|2-Sided|95.0|-370.9|-242.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670461|NCT01380093|3073790|Superiority or Other||LS Mean Difference|404.9|||<|0.0001|2-Sided|95.0|356.4|453.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670462|NCT01380093|3073790|Superiority or Other||LS Mean Difference|151.9|||<|0.0001|2-Sided|95.0|103.5|200.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670463|NCT01380093|3073790|Superiority or Other||LS Mean Difference|-253.0|||<|0.0001|2-Sided|95.0|-301.5|-204.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670464|NCT01380093|3073791|Superiority or Other||LS Mean Difference|324.6|||<|0.0001|2-Sided|95.0|287.7|361.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670465|NCT01380093|3073791|Superiority or Other||LS Mean Difference|122.5|||<|0.0001|2-Sided|95.0|85.7|159.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670466|NCT01380093|3073791|Superiority or Other||LS Mean Difference|-202.2|||<|0.0001|2-Sided|95.0|-239.0|-165.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670467|NCT01380093|3073792|Superiority or Other||LS Mean Difference|175.8|||<|0.0001|2-Sided|95.0|155.4|196.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670468|NCT01380093|3073792|Superiority or Other||LS Mean Difference|59.7|||<|0.0001|2-Sided|95.0|39.3|80.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670469|NCT01380093|3073792|Superiority or Other||LS Mean Difference|-116.1|||<|0.0001|2-Sided|95.0|-136.5|-95.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670470|NCT01380093|3073793|Superiority or Other||LS Mean Difference|24.7|||<|0.0001|2-Sided|95.0|20.3|29.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670471|NCT01380093|3073793|Superiority or Other||LS Mean Difference|9.3|||<|0.0001|2-Sided|95.0|4.8|13.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670472|NCT01380093|3073793|Superiority or Other||LS Mean Difference|-15.4|||<|0.0001|2-Sided|95.0|-19.9|-11.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670473|NCT01380093|3073794|Superiority or Other||LS Mean Difference|-3.0||||0.0251|2-Sided|95.0|-5.6|-0.4|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670474|NCT01380093|3073794|Superiority or Other||LS Mean Difference|-1.0||||0.4592|2-Sided|95.0|-3.6|1.6|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670475|NCT01380093|3073794|Superiority or Other||LS Mean Difference|2.0||||0.1254|2-Sided|95.0|-0.6|4.7|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670476|NCT01380093|3073795|Superiority or Other||LS Mean Difference|156.0|||<|0.0001|2-Sided|95.0|105.7|206.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670477|NCT01380093|3073795|Superiority or Other||LS Mean Difference|69.8|||<|0.0071|2-Sided|95.0|19.7|120.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670478|NCT01380093|3073795|Superiority or Other||LS Mean Difference|-86.2|||<|0.0011|2-Sided|95.0|-136.5|-35.9|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670479|NCT01380093|3073796|Superiority or Other||LS Mean Difference|142.5|||<|0.0001|2-Sided|95.0|105.7|179.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670480|NCT01380093|3073796|Superiority or Other||LS Mean Difference|66.5|||<|0.0006|2-Sided|95.0|29.8|103.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670481|NCT01380093|3073796|Superiority or Other||LS Mean Difference|-76.0|||<|0.0001|2-Sided|95.0|-112.8|-39.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670482|NCT01380093|3073797|Superiority or Other||LS Mean Difference|125.1|||<|0.0001|2-Sided|95.0|98.7|151.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670483|NCT01380093|3073797|Superiority or Other||LS Mean Difference|56.5|||<|0.0001|2-Sided|95.0|30.1|82.8|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670484|NCT01380093|3073797|Superiority or Other||LS Mean Difference|-68.6|||<|0.0001|2-Sided|95.0|-95.0|-42.2|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670485|NCT01380093|3073798|Superiority or Other||LS Mean Difference|77.8|||<|0.0001|2-Sided|95.0|64.5|91.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670486|NCT01380093|3073798|Superiority or Other||LS Mean Difference|29.0|||<|0.0001|2-Sided|95.0|15.8|42.3|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670487|NCT01380093|3073798|Superiority or Other||LS Mean Difference|-48.8|||<|0.0001|2-Sided|95.0|-62.0|-35.5|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670488|NCT01380093|3073799|Superiority or Other||LS Mean Difference|14.1|||<|0.0001|2-Sided|95.0|11.2|17.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670489|NCT01380093|3073799|Superiority or Other||LS Mean Difference|5.2|||<|0.0006|2-Sided|95.0|2.3|8.1|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670490|NCT01380093|3073799|Superiority or Other||LS Mean Difference|-8.9|||<|0.0001|2-Sided|95.0|-11.8|-6.0|||Mixed Models Analysis|||LS mean, 95% CI, and unadjusted p-value were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670491|NCT01380093|3073800|Superiority or Other||LS Mean Difference|75.7|||<|0.0001|2-Sided|95.0|65.6|85.8||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670492|NCT01380093|3073800|Superiority or Other||LS Mean Difference|24.6|||<|0.0001|2-Sided|95.0|14.5|34.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670493|NCT01380093|3073800|Superiority or Other||LS Mean Difference|-51.1|||<|0.0001|2-Sided|95.0|-61.2|-41.0||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670494|NCT01380093|3073801|Superiority or Other||LS Mean Difference|29.1|||<|0.0001|2-Sided|95.0|24.6|33.7||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670495|NCT01380093|3073801|Superiority or Other||LS Mean Difference|13.4|||<|0.0001|2-Sided|95.0|8.9|18.0||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670496|NCT01380093|3073801|Superiority or Other||LS Mean Difference|-15.7|||<|0.0001|2-Sided|95.0|-20.2|-11.1||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence. Planned power of at least 89% assumed a mean difference of 15 to 30 points and a standard deviation of paired differences of 15 to 20 points, with conservative multiple comparison adjustment for alpha of 0.025.|
1670497|NCT01380093|3073802|Superiority or Other||LS Mean Difference|36.8|||<|0.0001|2-Sided|95.0|30.0|43.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670498|NCT01380093|3073802|Superiority or Other||LS Mean Difference|11.9|||<|0.0009|2-Sided|95.0|5.1|18.6||p-value adjusted for multiple comparisons with Hochberg adjustment.|Mixed Models Analysis|||LS mean and 95% CI were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670499|NCT01380093|3073802|Superiority or Other||LS Mean Difference|-24.9|||<|0.0001|2-Sided|95.0|-31.7|-18.1||p-value adjusted for multiple comparisons with Hochberg adjustment. At least one primary outcome for each of drug liking and high was required to be significant with adjusted p-value less than or equal to 0.05.|Mixed Models Analysis|||Least square (LS) mean and 95% confidence interval (CI) were calculated using linear mixed model with fixed effects for sequence, period and treatment, and a random effect for participant nested in sequence.|
1670500|NCT01380080|3073817|Superiority or Other||Cumulative probability difference|-0.06||||0.97|2-Sided|95.0|-3.05|2.94|||z-test|||Treatment comparison was made using the difference (arm B- arm A) in the Kaplan-Meier estimate for 24 week cumulative probability of death or unknown vital status with 95% confidence interval|
1670501|NCT01379781|3073841|Superiority||Slope|0.0||||0.01|2-Sided||||||Mixed Models Analysis|||Mixed effect model was used to compare Hamilton Rating Scales of Depression (HRSD) for women who received the PREPP intervention between the pre–randomization assessment and the 6 weeks postpartum session.|
1670502|NCT01379664|3073872|Superiority or Other||Mean Difference (Final Values)|-0.69||||0.74|2-Sided|95.0|-4.7|3.3|||Generalized estimating equation model|Generalized estimating equation model weighted by propensity score|||
1670503|NCT01379664|3073873|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.87|2-Sided|95.0|-0.23|0.19|||Generalized estimating equation model|Generalized estimating equation model weighted by inverse propensity score|||
1670504|NCT01379664|3073874|Superiority or Other||Ratio of Geometric Means|1.06||||0.24|2-Sided|95.0|0.97|1.16|||Wilcoxon (Mann-Whitney)||||
1670539|NCT01377922|3074057|Other|||||||0.0267|||||||Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction as fixed effects and patient as a random effect. The model assumed time effect to be random between patients|
1670505|NCT01379508|3073906|Non-Inferiority or Equivalence|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-2.3|||||2-Sided|95.0|-8.3|3.8||||||Imputing within +28d DNA for wk52: d/c for non response <28 days from Wk 52:Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with the earliest available assessment within the 28-day window starting from the scheduled Week 52 date for other patients (if no such assessment is available, treated as failure)|
1670506|NCT01379508|3073906|Non-Inferiority or Equivalence|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-3.8|||||2-Sided|95.0|-7.9|0.4||||||Imputing LOCF DNA for wk 52: d/c for non response prior to Wk 52: Treating missing as failure for patients who discontinued prior to Week 52 due to unsatisfactory therapeutic effect and imputing missing with LOCF for other patients|
1670507|NCT01379508|3073906|Non-Inferiority or Equivalence|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference was above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-3.1|||||2-Sided|95.0|-9.4|3.1||||||Imputing +/- 7 days DNA for Wk 52: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA < 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine – tenofovir arm) and the 95% CI of the difference.|
1670508|NCT01379508|3073906|Non-Inferiority or Equivalence|Noninferiority was derived if the lower limit of two-sided 95% CI for the difference lied above the pre-determined non-inferiority margin (-10%).|Difference in percentage|-4.0|||||2-Sided|95.0|-10.5|2.5||||||Missing DNA data at Wk 52=failure: To evaluate the primary objective, Mantel-Haenszel weighted estimates approach (stratified by HBV DNA level (< 7 log10 copies/mL or ≥ 7 log10 copies/mL) and ALT (< 3×ULN or ≥ 3×ULN) at baseline) was employed to assess the proportion of patients (response rate) who achieve HBV DNA < 300 copies/mL after 52 weeks treatment in each treatment arm, as well as the difference in proportions (telbivudine – tenofovir arm) and the 95% CI of the difference.|
1670509|NCT01379183|3073908|Superiority or Other|||||||0.12|||||||ANCOVA||||
1670510|NCT01379183|3073909|Superiority or Other|||||||0.37|||||||ANCOVA||||
1670511|NCT01379183|3073910|Superiority or Other|||||||0.71|||||||ANCOVA||||
1670512|NCT01379183|3073911|Superiority or Other|||||||0.96|||||||ANCOVA||||
1670513|NCT01379183|3073912|Superiority or Other|||||||0.27|||||||ANCOVA||||
1670514|NCT01379183|3073913|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1670515|NCT01378429|3073967|Non-Inferiority or Equivalence|35 subjects per arm would have ≥90% power to demonstrate that the upper bound of a two-sided 95% confidence interval (equivalent to the upper bound of a one-sided 97.5% confidence interval) of the difference of placebo minus ciclesonide nasal aerosol would be less than 20% of the baseline value of 175 mcg•h/dL or a noninferiority limit of 35 mcg•h/dL assuming a SD of 40 and a one-sided α of 0.025. A total of 40 subjects will be randomly assigned to ensure 35 subjects complete the study per arm.|LS Mean Difference|7.6|||||2-Sided|95.0|-7.4|22.6|||||Difference is calculated as Placebo - Ciclesonide.|35 subjects per arm would have ≥90% power to demonstrate that the upper bound of a two-sided 95% confidence interval (equivalent to the upper bound of a one-sided 97.5% confidence interval) of the difference of placebo minus ciclesonide nasal aerosol would be less than 20% of the baseline value of 175 mcg•h/dL or a noninferiority limit of 35 mcg•h/dL assuming a SD of 40 and a one-sided α of 0.025. A total of 40 subjects will be randomly assigned to ensure 35 subjects complete the study per arm.|
1670516|NCT01378299|3073990|Other||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.|
1670517|NCT01378299|3073991|Other||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.|
1670518|NCT01378299|3073992|Other||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.|
1670519|NCT01378299|3073993|Other||||||<|0.05|||||||ANOVA|||Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline and with acceptable assay coefficient of variability were included in the analysis. The data of 79 subjects were analyzed; 15 in the GG, 43 in the GA and 21 in the AA genotype.|
1670520|NCT01378299|3073995|Other||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.|
1670521|NCT01378299|3073996|Other||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.|
1670522|NCT01378299|3073997|Other||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.|
1670523|NCT01378299|3073998|Other||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.|
1670524|NCT01378299|3073999|Other||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward.|
1670525|NCT01378299|3074000|Other||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with the last value carry forward|
1670526|NCT01378299|3074001|Other||||||<|0.05|||||||ANOVA|||Analysis by intention to treat with last value carry forward.|
1670527|NCT01378065|3074017|Superiority or Other (legacy)||||||<|0.001|||||||t-test, 2 sided|||Analysis baseline to 12 months.|
1670528|NCT01378065|3074018|Superiority or Other (legacy)||||||<|0.001|||||||t-test, 2 sided|||Analysis baseline to 6 months.|
1670529|NCT01378065|3074019|Superiority or Other (legacy)|||||||0.004|||||||t-test, 2 sided|||Analysis baseline to 3 months.|
1670530|NCT01378065|3074020|Superiority or Other (legacy)|||||||0.001|||||||t-test, 2 sided|||Analysis baseline to 6 weeks.|
1670531|NCT01378065|3074021|Superiority or Other (legacy)|||||||0.034|||||||t-test, 2 sided||||
1670532|NCT01378065|3074022|Superiority or Other (legacy)|||||||0.004|||||||t-test, 2 sided||||
1670533|NCT01378065|3074023|Superiority or Other (legacy)|||||||0.001|||||||t-test, 2 sided||||
1670534|NCT01378065|3074024|Superiority or Other (legacy)|||||||0.202|||||||t-test, 2 sided||||
1670535|NCT01378065|3074025|Superiority or Other (legacy)||||||<|0.001|||||||t-test, 2 sided||||
1670536|NCT01378065|3074026|Superiority or Other (legacy)||||||<|0.001|||||||t-test, 2 sided||||
1670540|NCT01377922|3074058|Other|||||||0.6274|||||||Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline T25FW walking speed as fixed effects and patient as a random effect. The model assumed time effect to be random between patients.|
1670541|NCT01377922|3074059|Other|||||||0.0028||||||Pairwise contrast at Day 14 from MMRM model.|Mixed Models Analysis|||Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline SGI score as fixed effects and patient as a random effect. The model assumed time effect to be random between patients|
1670542|NCT01377922|3074060|Other|Estimated via a MMRM with change from baseline (Day 1, Part 2), Day 8, and Day 14 as the dependent variable and terms for treatment, time (Day 8, Day 14), treatment-by-time interaction, and double-blind baseline QMG score as fixed effects and patient as a random effect. The model assumed time effect to be random between patients.||||||0.0452|||||||Mixed Models Analysis|Pairwise contrast at Day 14 from MMRM model.|||
1670543|NCT01377584|3074075|Other||Effect size|-0.26|||||2-Sided||||||||Comparing 1 month to 3 months||
1670544|NCT01377584|3074075|Other||Effect size|-0.92|||||2-Sided||||||||Comparing 1 week to 1 month||
1670545|NCT01377584|3074075|Other||Effect size|-0.63|||||2-Sided||||||||Comparing 1 month to 3 months||
1670546|NCT01377584|3074075|Other||Effect size|0.5|||||2-Sided||||||||Comparing 1 week to 1 month||
1670547|NCT01377584|3074075|Other||Effect size|-0.63|||||2-Sided||||||||Comparing 1 month and 3 months||
1670548|NCT01377584|3074075|Other||Effect size|0.52|||||2-Sided||||||||Comparing 1 week to 1 month||
1670549|NCT01377584|3074076|Other||Effect size|-0.77|||||2-Sided||||||||||
1670550|NCT01377584|3074076|Other||Effect size|-0.65|||||2-Sided||||||||||
1670551|NCT01377584|3074076|Other||Effect size|-0.31|||||2-Sided||||||||||
1670552|NCT01377584|3074076|Other||Effect size|-0.4|||||2-Sided||||||||||
1670553|NCT01377584|3074076|Other||Effect size|-0.94|||||2-Sided||||||||||
1670554|NCT01377584|3074076|Other||Effect size|-1.01|||||2-Sided||||||||||
1670555|NCT01377584|3074077|Other||Effect size|0.65|||||2-Sided||||||||||
1670556|NCT01377584|3074077|Other||Effect size|0.0|||||2-Sided||||||||||
1670557|NCT01377584|3074077|Other||Effect size|1.54|||||2-Sided||||||||||
1670558|NCT01377584|3074077|Other||Effect size|0.57|||||2-Sided||||||||||
1670559|NCT01377584|3074077|Other||Effect size|0.41|||||2-Sided||||||||||
1670560|NCT01377584|3074077|Other||Effect size|0.51|||||2-Sided||||||||||
1670561|NCT01377584|3074078|Other||Effect size|-0.77|||||2-Sided||||||||||
1670562|NCT01377584|3074078|Other||Effect size|-0.08|||||2-Sided||||||||||
1670563|NCT01377584|3074078|Other||Effect size|-1.31|||||2-Sided||||||||||
1670564|NCT01377584|3074078|Other||Effect size|-0.82|||||2-Sided||||||||||
1670565|NCT01377584|3074078|Other||Effect size|-0.42|||||2-Sided||||||||||
1670566|NCT01377584|3074078|Other||Effect size|-0.51|||||2-Sided||||||||||
1670567|NCT01377467|3074080|Superiority or Other||z value|-1.991||||0.048|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1670568|NCT01377467|3074081|Superiority or Other||z value|-1.64||||0.108|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1670569|NCT01377467|3074082|Superiority or Other||z value|-1.288||||0.212|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1670570|NCT01377467|3074083|Superiority or Other||z value|-2.166||||0.031|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1670571|NCT01377467|3074084|Superiority or Other||z value|-2.752||||0.005|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1670572|NCT01377467|3074085|Superiority or Other||z value|-0.937||||0.371|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1670573|NCT01377467|3074086|Superiority or Other||z value|-2.049||||0.042|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1670574|NCT01377467|3074087|Superiority or Other||z value|-2.342||||0.019|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1670575|NCT01377467|3074088|Superiority or Other||between-subjects effect|248.686||||0.607|2-Sided||||||repeated measures GLM||Within-subjects effect: p<0.001. Time*treatment interaction: p=0.296. The a priori threshold for statistical significance is <0.05.||
1670576|NCT01377467|3074089|Superiority or Other||between-subjects effect|84.83||||0.578|2-Sided||||||repeated measures GLM||Within-subjects effect: p<0.001. Time*treatment interaction: p=0.593. The a priori threshold for statistical significance is <0.05.||
1670577|NCT01377467|3074090|Superiority or Other||between-subjects effect|99952.126||||0.114|2-Sided||||||repeated measures GLM||Within-subjects effect: p<0.001. Time*treatment interaction: p=0.047. The a priori threshold for statistical significance is <0.05.||
1670578|NCT01377467|3074091|Superiority or Other||between-subjects effect|0.707||||0.068|2-Sided||||||repeated measures GLM||Within-subjects effect: p<0.001. Time*treatment interaction: p=0.047. The a priori threshold for statistical significance is <0.05.||
1670579|NCT01377467|3074092|Superiority or Other||between-subjects effect|0.717||||0.014|2-Sided||||||repeated measures GLM||Within-subjects effect: p<0.001. Time*treatment interaction: p<0.001. The a priori threshold for statistical significance is <0.05.||
1670580|NCT01377467|3074093|Superiority or Other||between-subjects effect|275622.016|||<|0.001|2-Sided||||||repeated measures GLM||Within-subjects effect: p<0.001. Time*treatment interaction: p=0.012. The a priori threshold for statistical significance is <0.05.||
1670581|NCT01377467|3074094|Superiority or Other||between-subjects effect|10.466|||<|0.001|2-Sided||||||repeated measures GLM||Within-subjects effect: p=0.007. Time*treatment interaction: p=0.002. The a priori threshold for statistical significance is <0.05.||
1670582|NCT01377467|3074095|Superiority or Other||Mean Difference (Final Values)|2.035|Standard Error of the Mean|1.085||0.064|2-Sided|95.0|-0.122|4.193|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.||
1670583|NCT01377467|3074096|Superiority or Other||Mean Difference (Final Values)|1.756|Standard Error of the Mean|0.662||0.009|2-Sided|95.0|0.44|3.072|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.||
1670705|NCT01375660|3074280|Superiority or Other|||||||0.22|||||||ANOVA||||
1670706|NCT01375660|3074281|Superiority or Other|||||||0.34||||||P Value for Insulinogenic Index-30 = 0.34|ANOVA||||
1670584|NCT01377467|3074097|Superiority or Other||Mean Difference (Final Values)|4.567|Standard Error of the Mean|0.806|<|0.001|2-Sided|95.0|2.975|6.178|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.||
1670585|NCT01377467|3074098|Superiority or Other||Mean Difference (Final Values)|1.059|Standard Error of the Mean|1.201||0.38|2-Sided|95.0|-1.329|3.447|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.||
1670586|NCT01377467|3074099|Superiority or Other||Mean Difference (Final Values)|1.895|Standard Error of the Mean|0.887||0.035|2-Sided|95.0|0.132|3.659|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.||
1670587|NCT01377467|3074100|Superiority or Other||Mean Difference (Final Values)|5.059|Standard Error of the Mean|0.967|<|0.001|2-Sided|95.0|3.137|6.98|||ANCOVA||Percentage change in BMD was compared between the two treatment groups while controlling for the effects of baseline BMD.|We calculated that a sample size of 43 patients per group would provide a statistical power of 86% to detect a 4% difference in the percentage change of areal BMD at the total lumbar spine at 12 months, using a two-sided t-test with an α-level of 0.05 and assuming a mean ± SD change of 4 ± 6% in the denosumab group and 0 ± 6% in the control group. To account for a dropout rate of 5%, it was planned to randomize a total of 90 patients.|
1670588|NCT01377194|3074115|Superiority or Other||Least squares mean difference|-2.72||||0.0028|2-Sided|95.0|-4.494|-0.946|||Mixed Models Analysis|Mixed-effects model for repeated measures.|||
1670589|NCT01377194|3074115|Superiority or Other||Least squares mean difference|-1.827||||0.0459|2-Sided|95.0|-3.62|-0.033|||Mixed Models Analysis|Mixed-effects model for repeated measures.|||
1670590|NCT01377194|3074116|Superiority or Other||Least squares mean difference|-3.141||||0.0043|2-Sided|95.0|-5.293|-0.988|||mixed-model for repeated measures||||
1670591|NCT01377194|3074116|Superiority or Other||Least squares mean difference|-3.303||||0.0027|2-Sided|95.0|-5.457|-1.148|||mixed-model for repeated measures||||
1670592|NCT01377012|3074123|Superiority or Other||Odds Ratio (OR)|2.21||||0.0004|2-Sided|95.0|1.4|3.4|||Regression, Logistic||||
1670593|NCT01377012|3074123|Superiority or Other||Odds Ratio (OR)|2.21||||0.0004|2-Sided|95.0|1.4|3.4|||Regression, Logistic||||
1670594|NCT01376349|3074199|Superiority or Other|||||||0.48|||||||Wilcoxon (Mann-Whitney)||||
1670595|NCT01376349|3074199|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1670596|NCT01376323|3074201|Superiority or Other||Mean Difference (Net)|-19.12|||||2-Sided|95.0|-36.55|-1.68|||||||
1670597|NCT01376323|3074201|Superiority or Other||Mean Difference (Net)|-14.09|||||2-Sided|95.0|-32.41|4.23|||||||
1670598|NCT01376323|3074201|Superiority or Other||Mean Difference (Net)|-15.1|||||2-Sided|95.0|-33.0|2.81|||||||
1670599|NCT01376323|3074201|Superiority or Other||Mean Difference (Net)|-1.58|||||2-Sided|95.0|-19.36|16.2|||||||
1670600|NCT01376323|3074203|Superiority or Other||Mean Difference (Net)|-2.09|||||2-Sided|95.0|-52.72|48.53|||||||
1670601|NCT01376323|3074203|Superiority or Other||Median Difference (Net)|24.08|||||2-Sided|95.0|-27.75|75.92|||||||
1670602|NCT01376323|3074203|Superiority or Other||Mean Difference (Net)|-7.67|||||2-Sided|95.0|-58.04|42.7|||||||
1670603|NCT01376323|3074203|Superiority or Other||Mean Difference (Net)|2.27|||||2-Sided|95.0|-48.62|53.16|||||||
1670604|NCT01376323|3074204|Superiority or Other||Mean Difference (Net)|-0.42|||||2-Sided|95.0|-1.27|0.42|||||||
1670605|NCT01376323|3074204|Superiority or Other||Mean Difference (Net)|-0.02|||||2-Sided|95.0|-0.9|0.85|||||||
1670606|NCT01376323|3074204|Superiority or Other||Mean Difference (Net)|-0.04|||||2-Sided|95.0|-0.9|0.82|||||||
1670607|NCT01376323|3074204|Superiority or Other||Mean Difference (Net)|0.07|||||2-Sided|95.0|-0.79|0.94|||||||
1670608|NCT01376323|3074206|Superiority or Other||Mean Difference (Net)|-0.083|||||2-Sided|95.0|-0.16|-0.007|||||Comparison for NEFA.||
1670609|NCT01376323|3074206|Superiority or Other||Mean Difference (Net)|0.021|||||2-Sided|95.0|-0.058|0.099|||||Comparison for NEFA.||
1670610|NCT01376323|3074206|Superiority or Other||Mean Difference (Net)|0.004|||||2-Sided|95.0|-0.073|0.081|||||Comparison for NEFA.||
1670611|NCT01376323|3074206|Superiority or Other||Mean Difference (Net)|0.036|||||2-Sided|95.0|-0.042|0.113|||||Comparison for NEFA.||
1670612|NCT01376323|3074206|Superiority or Other||Mean Difference (Net)|-0.595|||||2-Sided|95.0|-1.669|0.48|||||Comparison for glucose.||
1670613|NCT01376323|3074206|Superiority or Other||Mean Difference (Net)|-0.59|||||2-Sided|95.0|-1.696|0.516|||||Comparison for glucose.||
1670614|NCT01376323|3074206|Superiority or Other||Mean Difference (Net)|-0.382|||||2-Sided|95.0|-1.472|0.708|||||Comparison for glucose.||
1670615|NCT01376323|3074206|Superiority or Other||Mean Difference (Net)|-0.551|||||2-Sided|95.0|-1.645|0.543|||||Comparison for glucose.||
1670616|NCT01376323|3074207|Superiority or Other||Mean Difference (Net)|-0.3|||||2-Sided|95.0|-0.66|0.06|||||||
1670617|NCT01376323|3074207|Superiority or Other||Mean Difference (Net)|-0.13|||||2-Sided|95.0|-0.49|0.23|||||||
1670618|NCT01376323|3074207|Superiority or Other||Mean Difference (Net)|-0.01|||||2-Sided|95.0|-0.37|0.35|||||||
1670619|NCT01376323|3074207|Superiority or Other||Mean Difference (Net)|0.24|||||2-Sided|95.0|-0.13|0.6|||||||
1670620|NCT01376245|3074218|Superiority or Other||Least Squares Mean Difference|0.194|||<|0.001|2-Sided|95.0|0.143|0.245|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)|||
1670621|NCT01376245|3074218|Superiority or Other||Least Squares Mean Difference|0.179|||<|0.001|2-Sided|95.0|0.129|0.23|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)|||
1670622|NCT01376245|3074218|Superiority or Other||Least Squares Mean Difference|0.14|||<|0.001|2-Sided|95.0|0.089|0.191|||Mixed Models Analysis|Restricted Maximum Likelihood (REML)-based repeated measures approach (MMRM)|||
1670623|NCT01376167|3074241|Superiority||Hazard Ratio (HR)|0.255|||<|0.001|2-Sided|95.0|0.167|0.39||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio<1 indicated a lower chance of relapse compared to CQ only.||
1670624|NCT01376167|3074241|Superiority||Hazard Ratio (HR)|0.271|||<|0.001|2-Sided|95.0|0.195|0.376||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio<1 indicated a lower chance of relapse compared to CQ only.||
1670625|NCT01376167|3074242|Superiority||Odds Ratio (OR)|0.198|||<|0.001|2-Sided|95.0|0.117|0.335||Logistic regression model was fitted with region and treatment as covariates. Participants with a zero P vivax asexual parasite count at Baseline were excluded from the analysis.|Regression, Logistic||Odds ratios < 1 suggested a smaller chance of recurrence compared to CQ Only.||
1670626|NCT01376167|3074242|Superiority||Odds Ratio (OR)|0.241|||<|0.001|2-Sided|95.0|0.152|0.382||Logistic regression model was fitted with region and treatment as covariates. Participants with a zero P vivax asexual parasite count at Baseline were excluded from the analysis.|Regression, Logistic||Odds ratios < 1 suggested a smaller chance of recurrence compared to CQ Only.||
1670627|NCT01376167|3074242|Superiority||Hazard Ratio (HR)|0.262|||<|0.001|2-Sided|95.0|0.178|0.387||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio<1 indicated a lower chance of relapse compared to CQ only.||
1670628|NCT01376167|3074242|Superiority||Hazard Ratio (HR)|0.299|||<|0.001|2-Sided|95.0|0.222|0.404||The Cox proportional hazards model was fitted with region and treatment as covariates.|Cox Proportional Hazards Model||A hazard ratio<1 indicated a lower chance of relapse compared to CQ only.||
1670629|NCT01376050|3074246|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1670630|NCT01376050|3074247|Superiority or Other||||||>|0.05|||||||Fisher Exact||||
1670631|NCT01375777|3074254|Superiority or Other||LS Mean Treatment Difference|-36.25|Standard Error of the Mean|3.37|<|0.001|2-Sided|95.0|-42.9|-29.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670632|NCT01375777|3074254|Superiority or Other||LS Mean Treatment Difference|-40.57|Standard Error of the Mean|3.37|<|0.001|2-Sided|95.0|-47.22|-33.92||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670633|NCT01375777|3074254|Superiority or Other||LS Mean Treatment Difference|-45.47|Standard Error of the Mean|3.37|<|0.001|2-Sided|95.0|-52.12|-38.82||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670634|NCT01375777|3074254|Superiority or Other||LS Mean Treatment Difference|-34.83|Standard Error of the Mean|3.32|<|0.001|2-Sided|95.0|-41.38|-28.28||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670635|NCT01375777|3074254|Superiority or Other||LS Mean Treatment Difference|-40.33|Standard Error of the Mean|3.3|<|0.001||95.0|-46.84|-33.82||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670636|NCT01375777|3074254|Superiority or Other||LS Mean Treatment Difference|-50.16|Standard Error of the Mean|3.34|<|0.001|2-Sided|95.0|-56.75|-43.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670637|NCT01375777|3074255|Superiority or Other||LS Mean Treatment Difference|-28.69|Standard Error of the Mean|2.89|<|0.001|2-Sided|95.0|-34.39|-22.98||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670638|NCT01375777|3074255|Superiority or Other||LS Mean Treatment Difference|-31.21|Standard Error of the Mean|2.89|<|0.001|2-Sided|95.0|-36.92|-25.51||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670639|NCT01375777|3074255|Superiority or Other||LS Mean Treatment Difference|-36.58|Standard Error of the Mean|2.89|<|0.001|2-Sided|95.0|-42.29|-30.88||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670640|NCT01375777|3074255|Superiority or Other||LS Mean Treatment Difference|-28.86|Standard Error of the Mean|2.99|<|0.001|2-Sided|95.0|-34.77|-22.95||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670641|NCT01375777|3074255|Superiority or Other||LS Mean Treatment Difference|-31.92|Standard Error of the Mean|2.98|<|0.001||95.0|-37.79|-26.04||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670642|NCT01375777|3074255|Superiority or Other||LS Mean Treatment Difference|-37.49|Standard Error of the Mean|3.01|<|0.001|2-Sided|95.0|-43.43|-31.54||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670643|NCT01375777|3074256|Superiority or Other||LS Mean Treatment Difference|-33.22|Standard Error of the Mean|3.12|<|0.001|2-Sided|95.0|-39.38|-27.07||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670644|NCT01375777|3074256|Superiority or Other||LS Mean Treatment Difference|-37.92|Standard Error of the Mean|3.12|<|0.001|2-Sided|95.0|-44.07|-31.76||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670645|NCT01375777|3074256|Superiority or Other||LS Mean Treatment Difference|-42.48|Standard Error of the Mean|3.12|<|0.001|2-Sided|95.0|-48.63|-36.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670646|NCT01375777|3074256|Superiority or Other||LS Mean Treatment Difference|-32.33|Standard Error of the Mean|3.15|<|0.001|2-Sided|95.0|-38.55|-26.11||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670647|NCT01375777|3074256|Superiority or Other||LS Mean Treatment Difference|-35.87|Standard Error of the Mean|3.13|<|0.001||95.0|-42.06|-29.69||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670648|NCT01375777|3074256|Superiority or Other||LS Mean Treatment Difference|-44.19|Standard Error of the Mean|3.17|<|0.001|2-Sided|95.0|-50.45|-37.94||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670707|NCT01375660|3074282|Superiority or Other|||||||0.389|||||||ANOVA||||
1670708|NCT01375660|3074283|Superiority or Other|||||||0.6|||||||ANOVA||||
1670709|NCT01375660|3074284|Superiority or Other|||||||0.026|||||||ANOVA||||
1670649|NCT01375777|3074257|Superiority or Other||LS Mean Treatment Difference|-37.7|Standard Error of the Mean|3.15|<|0.001|2-Sided|95.0|-43.92|-31.47||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670650|NCT01375777|3074257|Superiority or Other||LS Mean Treatment Difference|-41.89|Standard Error of the Mean|3.15|<|0.001|2-Sided|95.0|-48.11|-35.67||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670651|NCT01375777|3074257|Superiority or Other||LS Mean Treatment Difference|-47.11|Standard Error of the Mean|3.15|<|0.001|2-Sided|95.0|-53.33|-40.89||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670652|NCT01375777|3074257|Superiority or Other||LS Mean Treatment Difference|-35.06|Standard Error of the Mean|3.31|<|0.001|2-Sided|95.0|-41.59|-28.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670653|NCT01375777|3074257|Superiority or Other||LS Mean Treatment Difference|-36.79|Standard Error of the Mean|3.29|<|0.001||95.0|-43.29|-30.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670654|NCT01375777|3074257|Superiority or Other||LS Mean Treatment Difference|-45.15|Standard Error of the Mean|3.33|<|0.001|2-Sided|95.0|-51.72|-38.58||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670655|NCT01375777|3074258|Superiority or Other||LS Mean Treatment Difference|-60.8|Standard Error of the Mean|5.0|<|0.001|2-Sided|95.0|-70.7|-50.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670656|NCT01375777|3074258|Superiority or Other||LS Mean Treatment Difference|-63.9|Standard Error of the Mean|5.0|<|0.001|2-Sided|95.0|-73.9|-54.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670657|NCT01375777|3074258|Superiority or Other||LS Mean Treatment Difference|-72.3|Standard Error of the Mean|5.0|<|0.001|2-Sided|95.0|-82.2|-62.4||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670658|NCT01375777|3074258|Superiority or Other||LS Mean Treatment Difference|-52.3|Standard Error of the Mean|5.3|<|0.001|2-Sided|95.0|-62.7|-41.9||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670659|NCT01375777|3074258|Superiority or Other||LS Mean Treatment Difference|-62.7|Standard Error of the Mean|5.3|<|0.001||95.0|-73.2|-52.2||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670660|NCT01375777|3074258|Superiority or Other||LS Mean Treatment Difference|-65.9|Standard Error of the Mean|5.2|<|0.001|2-Sided|95.0|-76.3|-55.6||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference||
1670661|NCT01375777|3074259|Superiority or Other||LS Mean Treatment Difference|-43.57|Standard Error of the Mean|3.62|<|0.001|2-Sided|95.0|-50.71|-36.42||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1670662|NCT01375777|3074259|Superiority or Other||LS Mean Treatment Difference|-47.74|Standard Error of the Mean|3.62|<|0.001|2-Sided|95.0|-54.89|-40.6||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1670663|NCT01375777|3074259|Superiority or Other||LS Mean Treatment Difference|-52.53|Standard Error of the Mean|3.62|<|0.001|2-Sided|95.0|-59.67|-45.38||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1670664|NCT01375777|3074259|Superiority or Other||LS Mean Treatment Difference|-32.27|Standard Error of the Mean|3.68|<|0.001|2-Sided|95.0|-44.53|-30.02||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1670665|NCT01375777|3074259|Superiority or Other||LS Mean Treatment Difference|-40.17|Standard Error of the Mean|3.66|<|0.001||95.0|-47.38|-32.95||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1670666|NCT01375777|3074259|Superiority or Other||LS Mean Treatment Difference|-47.23|Standard Error of the Mean|3.7|<|0.001|2-Sided|95.0|-54.52|-39.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group and the stratification factor.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and placebo, and the alternative hypothesis was that a mean difference did exist.|
1670667|NCT01375764|3074260|Superiority or Other||LS Mean Treatment Difference|-41.25|Standard Error of the Mean|2.87|<|0.001|2-Sided|95.0|-46.99|-35.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.||
1670668|NCT01375764|3074261|Superiority or Other||LS Mean Treatment Difference|-25.1|Standard Error of the Mean|3.27|<|0.001|2-Sided|95.0|-31.57|-18.62||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670669|NCT01375764|3074261|Superiority or Other||LS Mean Treatment Difference|-26.81|Standard Error of the Mean|3.3|<|0.001|2-Sided|95.0|-33.35|-20.27||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670670|NCT01375764|3074261|Superiority or Other||LS Mean Treatment Difference|-34.05|Standard Error of the Mean|3.3|<|0.001|2-Sided|95.0|-40.57|-27.52||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670671|NCT01375764|3074262|Superiority or Other||LS Mean Treatment Difference|-37.92|Standard Error of the Mean|2.92|<|0.001|2-Sided|95.0|-43.77|-32.07||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.||
1670672|NCT01375764|3074263|Superiority or Other||LS Mean Treatment Difference|-22.36|Standard Error of the Mean|3.31|<|0.001|2-Sided|95.0|-28.92|-15.8||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670673|NCT01375764|3074263|Superiority or Other||LS Mean Treatment Difference|-23.91|Standard Error of the Mean|3.34|<|0.001|2-Sided|95.0|-30.53|-17.29||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670674|NCT01375764|3074263|Superiority or Other||LS Mean Treatment Difference|-30.95|Standard Error of the Mean|3.34|<|0.001|2-Sided|95.0|-37.56|-24.34||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670675|NCT01375764|3074264|Superiority or Other||LS Mean Treatment Difference|-38.23|Standard Error of the Mean|2.79|<|0.001|2-Sided|95.0|-43.81|-32.64||Testing based on a significance level of 0.05|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.||
1670676|NCT01375764|3074265|Superiority or Other||LS Mean Treatment Difference|-21.38|Standard Error of the Mean|3.49|<|0.001|2-Sided|95.0|-28.29|-14.48||Testing based on a signficance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670677|NCT01375764|3074265|Superiority or Other||LS Mean Treatment Difference|-22.13|Standard Error of the Mean|3.52|<|0.001|2-Sided|95.0|-29.1|-15.16||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670678|NCT01375764|3074265|Superiority or Other||LS Mean Teatment Difference|-29.88|Standard Error of the Mean|3.52|<|0.001|2-Sided|95.0|-36.84|-22.92||Testing based on a significance level of 0.05|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670679|NCT01375764|3074266|Superiority or Other||LS Mean Treatment Difference|-45.0|Standard Error of the Mean|2.9|<|0.001|2-Sided|95.0|-50.81|-39.18||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.||
1670680|NCT01375764|3074267|Superiority or Other||LS Mean Treatment Difference|-24.86|Standard Error of the Mean|3.67|<|0.001|2-Sided|95.0|-32.13|-17.59||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670681|NCT01375764|3074267|Superiority or Other||LS Mean Treatment Difference|-26.66|Standard Error of the Mean|3.7|<|0.001|2-Sided|95.0|-33.99|-19.32||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670682|NCT01375764|3074267|Superiority or Other||LS Mean Treatment Difference|-33.6|Standard Error of the Mean|3.7|<|0.001|2-Sided|95.0|-40.93|-26.28||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670683|NCT01375764|3074268|Superiority or Other||LS Mean Treatment Difference|-91.9|Standard Error of the Mean|8.4|<|1|2-Sided|95.0|-108.7|-75.0||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.||
1670684|NCT01375764|3074269|Superiority or Other||LS Mean Treatment Difference|-52.6|Standard Error of the Mean|9.2|<|0.001|2-Sided|95.0|-70.8|-34.5||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670685|NCT01375764|3074269|Superiority or Other||LS Mean Treatment Difference|-55.5|Standard Error of the Mean|9.3|<|0.001|2-Sided|95.0|-74.0|-37.1||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670686|NCT01375764|3074269|Superiority or Other||LS Mean Treatment Difference|-76.6|Standard Error of the Mean|9.2|<|0.001|2-Sided|95.0|-94.9|-58.3||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.||
1670710|NCT01375491|3074290|Superiority or Other (legacy)||||||<|0.05||||||See published paper.|ANOVA|See published paper.||See published paper.|
1670751|NCT01375075|3074315|Superiority or Other||LS Mean Difference|0.18|Standard Error of the Mean|0.43||0.678|2-Sided|90.0|-0.53|0.89|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670687|NCT01375764|3074270|Superiority or Other||LS Mean Treatment Difference|-47.29|Standard Error of the Mean|3.22|<|0.001|2-Sided|95.0|-53.73|-40.84||Testing based on a significance level of 0.05.|ANCOVA|The ANCOVA model included treatment group (evolocumab + ezetimibe and ezetimibe alone) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab + ezetimibe and ezetimibe alone, and the alternative hypothesis was that a mean difference did exist.|
1670688|NCT01375764|3074271|Superiority or Other||LS Mean Tretament Difference|-26.01|Standard Error of the Mean|4.08|<|0.001|2-Sided|95.0|-34.08|-17.93||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1670689|NCT01375764|3074271|Superiority or Other||LS Mean Treatment Difference|-27.82|Standard Error of the Mean|4.12|<|0.001|2-Sided|95.0|-35.97|-19.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1670690|NCT01375764|3074271|Superiority or Other||LS Mean Treatment Difference|-35.94|Standard Error of the Mean|4.11|<|0.001|2-Sided|95.0|-44.08|-27.8||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|The ANCOVA model included treatment group (3 evolocumab alone dose groups and the ezetimibe group) and the stratification factors.|Ezetimibe is the reference.|The null hypothesis was that there was no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis was that a mean difference did exist.|
1670691|NCT01375751|3074272|Superiority or Other||LS Mean Treatment Difference|-44.64|Standard Error of the Mean|3.43|<|0.001|2-Sided|95.0|-51.41|-37.86||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference||
1670692|NCT01375751|3074272|Superiority or Other||LS Mean Treatment Difference|-33.92|Standard Error of the Mean|3.45|<|0.001|2-Sided|95.0|-40.72|-27.11||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference||
1670693|NCT01375751|3074273|Superiority or Other||LS Mean Treatment Difference|-45.01|Standard Error of the Mean|3.7|<|0.001|2-Sided|95.0|-52.32|-37.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference||
1670694|NCT01375751|3074273|Superiority or Other||LS Mean Treatment Difference|-36.66|Standard Error of the Mean|3.72|<|0.001|2-Sided|95.0|-44.01|-29.32||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placbo is the reference||
1670695|NCT01375751|3074274|Superiority or Other||LS Mean Treatment Difference|-46.2|Standard Error of the Mean|3.53|<|0.001|2-Sided|95.0|-53.18|-39.23||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference||
1670696|NCT01375751|3074274|Superiority or Other||LS Mean Treatment Difference|-34.75|Standard Error of the Mean|3.55|<|0.001|2-Sided|95.0|-41.77|-27.74||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference||
1670697|NCT01375751|3074275|Superiority or Other||LS Mean Treatment Difference|-53.46|Standard Error of the Mean|3.79|<|0.001|2-Sided|95.0|-60.95|-45.97||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference||
1670698|NCT01375751|3074275|Superiority or Other||LS Mean Treatment Difference|-41.79|Standard Error of the Mean|3.81|<|0.001|2-Sided|95.0|-49.32|-34.26||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference||
1670699|NCT01375751|3074276|Superiority or Other||LS Mean Treatment Difference|-84.7|Standard Error of the Mean|7.1|<|0.001|2-Sided|95.0|-98.8|-70.7||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference||
1670700|NCT01375751|3074276|Superiority or Other||LS Mean Treatment Difference|-65.5|Standard Error of the Mean|7.1|<|0.001|2-Sided|95.0|-79.6|-51.4||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference||
1670701|NCT01375751|3074277|Superiority or Other||LS Mean Treatment Difference|-56.36|Standard Error of the Mean|3.9|<|0.001|2-Sided|95.0|-64.06|-48.67||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference|The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.|
1670702|NCT01375751|3074277|Superiority or Other||LS Mean Treatment Difference|-43.82|Standard Error of the Mean|3.92|<|0.001|2-Sided|95.0|-51.56|-36.09||Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.|ANCOVA|ANCOVA model includes treatment group and LDL-C level and baseline ezetimibe use as covariates.|Placebo is the reference.|The null hypothesis was that there was no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and placebo.|
1670703|NCT01375660|3074278|Superiority or Other|||||||0.869|||||||Chi-squared||||
1670704|NCT01375660|3074279|Superiority or Other|||||||0.13|||||||Chi-squared||||
1670711|NCT01375075|3074309|Superiority or Other||LS Mean Difference|-14.63|Standard Error of the Mean|4.88||0.003|2-Sided|90.0|-22.72|-6.55||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670712|NCT01375075|3074309|Superiority or Other||LS Mean Difference|103.25|Standard Error of the Mean|12.64|<|0.001|2-Sided|90.0|82.32|124.18||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670713|NCT01375075|3074309|Superiority or Other||LS Mean Difference|-22.19|Standard Error of the Mean|4.91|<|0.001|2-Sided|90.0|-30.32|-14.06||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.|
1670714|NCT01375075|3074309|Superiority or Other||LS Mean Difference|-23.37|Standard Error of the Mean|4.83|<|0.001|2-Sided|90.0|-31.37|-15.38||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.|
1670715|NCT01375075|3074309|Superiority or Other||LS Mean Difference|-15.47|Standard Error of the Mean|4.85|<|0.002|2-Sided|90.0|-23.5|-7.43||The P-value is for percent change from baseline in LDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.|
1670716|NCT01375075|3074309|Superiority or Other||LS Mean Difference|135.57|Standard Error of the Mean|12.72|<|0.001|2-Sided|90.0|114.5|156.63||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.|
1670717|NCT01375075|3074309|Superiority or Other||LS Mean Difference|115.36|Standard Error of the Mean|12.55|<|0.001|2-Sided|90.0|94.58|136.14||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.|
1670718|NCT01375075|3074309|Superiority or Other||LS Mean Difference|74.23|Standard Error of the Mean|12.59|<|0.001|2-Sided|90.0|53.38|95.07||The P-value is for percent change from baseline in HDL-C at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.||Comparisons between LY2484595 and Placebo were the primary focus for this endpoint.|
1670719|NCT01375075|3074310|Superiority or Other||LS Mean Difference|2.14|Standard Error of the Mean|0.29|<|0.001|2-Sided|90.0|1.65|2.63||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670720|NCT01375075|3074310|Superiority or Other||LS Mean Difference|3.24|Standard Error of the Mean|0.3|<|0.001|2-Sided|90.0|2.74|3.73||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670721|NCT01375075|3074310|Superiority or Other||LS Mean Difference|2.83|Standard Error of the Mean|0.29|<|0.001|2-Sided|90.0|2.34|3.31||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670722|NCT01375075|3074310|Superiority or Other||LS Mean Difference|1.82|Standard Error of the Mean|0.29|<|0.001|2-Sided|90.0|1.34|2.31||The P-value is for change from baseline in plasma CETP mass at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670723|NCT01375075|3074310|Superiority or Other||LS Mean Difference|2.04|Standard Error of the Mean|0.29|<|0.001|2-Sided|90.0|1.56|2.52||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670724|NCT01375075|3074310|Superiority or Other||LS Mean Difference|3.92|Standard Error of the Mean|0.3|<|0.001|2-Sided|90.0|3.42|4.41||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670725|NCT01375075|3074310|Superiority or Other||LS Mean Difference|2.99|Standard Error of the Mean|0.29|<|0.001|2-Sided|90.0|2.51|3.47||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670726|NCT01375075|3074310|Superiority or Other||LS Mean Difference|1.88|Standard Error of the Mean|0.29|<|0.001|2-Sided|90.0|1.4|2.36||The P-value is for change from baseline in plasma CETP mass at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670727|NCT01375075|3074310|Superiority or Other||LS Mean Difference|2.22|Standard Error of the Mean|0.25|<|0.001|2-Sided|90.0|1.81|2.63||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670728|NCT01375075|3074310|Superiority or Other||LS Mean Difference|3.46|Standard Error of the Mean|0.25|<|0.001|2-Sided|90.0|3.04|3.88||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670729|NCT01375075|3074310|Superiority or Other||LS Mean Difference|3.06|Standard Error of the Mean|0.25|<|0.001|2-Sided|90.0|2.65|3.48||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670730|NCT01375075|3074310|Superiority or Other||LS Mean Difference|1.8|Standard Error of the Mean|0.25|<|0.001|2-Sided|90.0|1.38|2.21||The P-value is for change from baseline in plasma CETP mass at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670731|NCT01375075|3074311|Superiority or Other||LS Mean Difference|-67.68|Standard Error of the Mean|5.15|<|0.001|2-Sided|90.0|-76.2|-59.16||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670732|NCT01375075|3074311|Superiority or Other||LS Mean Difference|-94.51|Standard Error of the Mean|5.08|<|0.001|2-Sided|90.0|-102.92|-86.1||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670733|NCT01375075|3074311|Superiority or Other||LS Mean Difference|-83.07|Standard Error of the Mean|4.98|<|0.001|2-Sided|90.0|-91.32|-74.83||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670734|NCT01375075|3074311|Superiority or Other||LS Mean Difference|-50.28|Standard Error of the Mean|4.98|<|0.001|2-Sided|90.0|-58.53|-42.04||The P-value is for percent change from baseline in plasma CETP activity at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670735|NCT01375075|3074311|Superiority or Other||LS Mean Difference|-75.01|Standard Error of the Mean|6.31|<|0.001|2-Sided|90.0|-85.46|-64.57||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670736|NCT01375075|3074311|Superiority or Other||LS Mean Difference|-93.67|Standard Error of the Mean|6.29|<|0.001|2-Sided|90.0|-104.08|-83.26||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670737|NCT01375075|3074311|Superiority or Other||LS Mean Difference|-78.93|Standard Error of the Mean|6.17|<|0.001|2-Sided|90.0|-89.15|-68.71||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670738|NCT01375075|3074311|Superiority or Other||LS Mean Difference|-42.6|Standard Error of the Mean|6.21|<|0.001|2-Sided|90.0|-52.88|-32.33||The P-value is for percent change from baseline in plasma CETP activity at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670739|NCT01375075|3074311|Superiority or Other||LS Mean Difference|-67.25|Standard Error of the Mean|5.96|<|0.001|2-Sided|90.0|-77.12|-57.39||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670740|NCT01375075|3074311|Superiority or Other||LS Mean Difference|-90.81|Standard Error of the Mean|6.08|<|0.001|2-Sided|90.0|-100.87|-80.75||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670741|NCT01375075|3074311|Superiority or Other||LS Mean Difference|-76.93|Standard Error of the Mean|6.02|<|0.001|2-Sided|90.0|-86.89|-66.97||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670742|NCT01375075|3074311|Superiority or Other||LS Mean Difference|-43.29|Standard Error of the Mean|5.97|<|0.001|2-Sided|90.0|-53.16|-33.41||The P-value is for percent change from baseline in plasma CETP activity at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670743|NCT01375075|3074312|Superiority or Other||LS Mean Difference|0.18|Standard Error of the Mean|0.13||0.181|2-Sided|90.0|-0.04|0.4|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.|||
1670744|NCT01375075|3074312|Superiority or Other||LS Mean Difference|0.14|Standard Error of the Mean|0.13||0.296|2-Sided|90.0|-0.08|0.36|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.|||
1670745|NCT01375075|3074312|Superiority or Other||LS Mean Difference|0.01|Standard Error of the Mean|0.13||0.939|2-Sided|90.0|-0.21|0.23|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.|||
1670746|NCT01375075|3074312|Superiority or Other||LS Mean Difference|-0.02|Standard Error of the Mean|0.13||0.888|2-Sided|90.0|-0.24|0.2|||ANCOVA|Treatment was included in the model as fixed effects, baseline hsCRP as covariate.|||
1670747|NCT01375075|3074314|Superiority or Other||LS Mean Difference|0.61|Standard Error of the Mean|0.61||0.317|2-Sided|90.0|-0.4|1.63|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670748|NCT01375075|3074314|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.62||0.869|2-Sided|90.0|-0.92|1.13|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670749|NCT01375075|3074314|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.61||0.869|2-Sided|90.0|-0.9|1.1|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670750|NCT01375075|3074314|Superiority or Other||LS Mean Difference|0.11|Standard Error of the Mean|0.61||0.856|2-Sided|90.0|-0.9|1.12|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670933|NCT01371838|3074715|Superiority or Other||Risk Difference (RD)|15.2|||||2-Sided|95.0|2.7|27.1|||||CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.||
1670752|NCT01375075|3074315|Superiority or Other||LS Mean Difference|0.25|Standard Error of the Mean|0.44||0.565|2-Sided|90.0|-0.47|0.97|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670753|NCT01375075|3074315|Superiority or Other||LS Mean Difference|-0.01|Standard Error of the Mean|0.43||0.99|2-Sided|90.0|-0.71|0.7|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670754|NCT01375075|3074315|Superiority or Other||LS Mean Difference|0.13|Standard Error of the Mean|0.43||0.756|2-Sided|90.0|-0.57|0.84|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670755|NCT01375075|3074316|Superiority or Other||LS Mean Difference|-0.41|Standard Error of the Mean|0.32||0.207|2-Sided|90.0|-0.95|0.13|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670756|NCT01375075|3074316|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.33||0.988|2-Sided|90.0|-0.53|0.54|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670757|NCT01375075|3074316|Superiority or Other||LS Mean Difference|0.22|Standard Error of the Mean|0.33||0.503|2-Sided|90.0|-0.32|0.76|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670758|NCT01375075|3074316|Superiority or Other||LS Mean Difference|-0.11|Standard Error of the Mean|0.33||0.735|2-Sided|90.0|-0.65|0.43|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670759|NCT01375075|3074317|Superiority or Other||LS Mean Difference|-0.33|Standard Error of the Mean|1.12||0.769|2-Sided|90.0|-2.18|1.52|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670760|NCT01375075|3074317|Superiority or Other||LS Mean Difference|0.26|Standard Error of the Mean|1.16||0.824|2-Sided|90.0|-1.66|2.17|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670761|NCT01375075|3074317|Superiority or Other||LS Mean Difference|0.04|Standard Error of the Mean|1.12||0.97|2-Sided|90.0|-1.82|1.9|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670762|NCT01375075|3074317|Superiority or Other||LS Mean Difference|-0.73|Standard Error of the Mean|1.11||0.513|2-Sided|90.0|-2.57|1.11|||Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670763|NCT01375075|3074318|Superiority or Other||LS Mean Difference|-0.98|Standard Error of the Mean|1.51||0.516|2-Sided|90.0|-3.47|1.51||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670764|NCT01375075|3074318|Superiority or Other||LS Mean Difference|1.83|Standard Error of the Mean|1.52||0.228|2-Sided|90.0|-0.67|4.34||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670765|NCT01375075|3074318|Superiority or Other||LS Mean Difference|-0.66|Standard Error of the Mean|1.48||0.656|2-Sided|90.0|-3.11|1.78||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670766|NCT01375075|3074318|Superiority or Other||LS Mean Difference|0.78|Standard Error of the Mean|1.5||0.603|2-Sided|90.0|-1.69|3.24||The P-value is for change from baseline in DBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670767|NCT01375075|3074318|Superiority or Other||LS Mean Difference|-0.54|Standard Error of the Mean|2.52||0.829|2-Sided|90.0|-4.71|3.62||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670768|NCT01375075|3074318|Superiority or Other||LS Mean Difference|5.9|Standard Error of the Mean|2.54||0.021|2-Sided|90.0|1.7|10.1||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670769|NCT01375075|3074318|Superiority or Other||LS Mean Difference|2.83|Standard Error of the Mean|2.48||0.257|2-Sided|90.0|-1.28|6.94||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670770|NCT01375075|3074318|Superiority or Other||LS Mean Difference|3.74|Standard Error of the Mean|2.5||0.136|2-Sided|90.0|-0.39|7.88||The P-value is for change from baseline in SBP at Week 12.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670771|NCT01375075|3074321|Superiority or Other||LS Mean Difference|-12.26|Standard Error of the Mean|4.77||0.011|2-Sided|90.0|-20.17|-4.36||The P-value is for percent change from baseline in LDL-C at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670772|NCT01375075|3074321|Superiority or Other||LS Mean Difference|-10.39|Standard Error of the Mean|4.4||0.019|2-Sided|90.0|-17.67|-3.11||The P-value is for percent change from baseline in LDL-C at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670794|NCT01374425|3074416|Superiority or Other||Difference in Resection Rates|-4.4|||||2-Sided|95.0|-9.5|0.6|||||The difference was calculated as the percentage of participants with resection in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.||
1670773|NCT01375075|3074321|Superiority or Other||LS Mean Difference|-17.46|Standard Error of the Mean|4.39|<|0.001|2-Sided|90.0|-24.73|-10.19||The P-value is for percent change from baseline in LDL-C at Week 2.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670774|NCT01375075|3074321|Superiority or Other||LS Mean Difference|103.66|Standard Error of the Mean|11.18|<|0.001|2-Sided|90.0|85.14|122.17||The P-value is for percent change from baseline in HDL-C at Week 8.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670775|NCT01375075|3074321|Superiority or Other||LS Mean Difference|106.17|Standard Error of the Mean|10.69|<|0.001|2-Sided|90.0|88.47|123.87||The P-value is for percent change from baseline in HDL-C at Week 4.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670776|NCT01375075|3074321|Superiority or Other||LS Mean Difference|92.61|Standard Error of the Mean|9.04|<|0.001|2-Sided|90.0|77.65|107.57||The P-value is for percent change from baseline in HDL-C at Week 2.|Mixed Models Analysis|Treatment, visit, and treatment by visit interaction were included in the model as fixed effects, baseline measurement as covariate.|||
1670777|NCT01374802|3074371|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|128.41|Standard Deviation|15.6|||2-Sided|90.0|115.724|142.489|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir|
1670778|NCT01374802|3074372|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|87.91|Standard Deviation|38.3|||2-Sided|90.0|68.609|112.63|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir|
1670779|NCT01374802|3074373|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|115.29|Standard Deviation|19.4|||2-Sided|90.0|101.36|131.13|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (Faldaprevir+DRV/r : DRV/r) of Darunavir|
1670780|NCT01374516|3074386|Superiority or Other||Vaccine Efficacy|61.9|||||2-Sided|95.0|54.7|68.0||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.|
1670781|NCT01374516|3074387|Superiority or Other||Vaccine Efficacy|64.7|||||2-Sided|95.0|58.7|69.9||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.|
1670782|NCT01374516|3074388|Superiority or Other||Vaccine Efficacy|64.7|||||2-Sided|95.0|58.7|69.8||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.|
1670783|NCT01374516|3074389|Superiority or Other||Vaccine Efficacy|60.8|||||2-Sided|95.0|52.0|68.0||||||The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow & Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.|
1670784|NCT01374451|3074401|Superiority or Other||Hazard Ratio (HR)|0.991||||0.488|2-Sided|95.0|0.636|1.543|||Log Rank||||
1670785|NCT01374425|3074407|Superiority or Other||Difference in Complete Resection Rates|-4.9|||||2-Sided|95.0|-9.6|-0.2|||||The difference was calculated as the percentage of participants with complete resection in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.||
1670786|NCT01374425|3074408|Superiority or Other||Difference in Resection Rates|-3.2|||||2-Sided|95.0|-8.6|2.1|||||The difference was calculated as the percentage of participants with resection in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.||
1670787|NCT01374425|3074409|Superiority or Other||Difference in Disease Control Rates|-1.1|||||2-Sided|95.0|-6.5|4.3|||||The difference was calculated as the percentage of participants with disease control in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.||
1670788|NCT01374425|3074410|Superiority or Other||Difference in Objective Response Rates|-5.4|||||2-Sided|95.0|-16.0|5.2|||||The difference was calculated as the percentage of participants with objective response in the KRAS Mutant subgroup minus the KRAS Wild-Type subgroup. The 95% CI was computed using normal approximation to the binomial distribution.||
1670789|NCT01374425|3074411|Superiority or Other||Difference in Objective Response Rates|-5.9|||||2-Sided|95.0|-15.7|3.8|||||The difference was calculated as the percentage of participants with objective response in the VEGF-A High subgroup minus the VEGF-A Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.||
1670790|NCT01374425|3074412|Superiority or Other||Hazard Ratio (HR)|1.34||||0.0955|2-Sided|95.0|0.95|1.88||P-value (relative to KRAS Wild-Type subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to KRAS Wild-Type subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.|
1670791|NCT01374425|3074413|Superiority or Other||Hazard Ratio (HR)|1.64||||0.002|2-Sided|95.0|1.2|2.24||P-value (relative to VEGF-A Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to VEGF-A Low subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.|
1670792|NCT01374425|3074414|Superiority or Other||Hazard Ratio (HR)|1.29||||0.0593|2-Sided|95.0|0.99|1.69||P-value (relative to KRAS Wild-Type subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to KRAS Wild-Type subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.|
1670793|NCT01374425|3074415|Superiority or Other||Difference in Complete Resection Rates|-1.6|||||2-Sided|95.0|-6.2|3.1|||||The difference was calculated as the percentage of participants with complete resection in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.||
1670795|NCT01374425|3074417|Superiority or Other||Difference in Complete Resection Rates|-5.5|||||2-Sided|95.0|-11.5|0.4|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.||
1670796|NCT01374425|3074418|Superiority or Other||Difference in Resection Rates|-3.0|||||2-Sided|95.0|-10.1|4.2|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.||
1670797|NCT01374425|3074419|Superiority or Other||Difference in Complete Resection Rates|-11.0|||||2-Sided|95.0|-33.1|11.1|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.||
1670798|NCT01374425|3074420|Superiority or Other||Difference in Resection Rates|-11.0|||||2-Sided|95.0|-33.1|11.1|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.||
1670799|NCT01374425|3074421|Superiority or Other||Difference in Complete Resection Rates|-6.5|||||2-Sided|95.0|-16.3|3.3|||||The difference was calculated as the percentage of participants with complete resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.||
1670800|NCT01374425|3074422|Superiority or Other||Difference in Resection Rates|-4.0|||||2-Sided|95.0|-15.9|7.8|||||The difference was calculated as the percentage of participants with resection in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.||
1670801|NCT01374425|3074423|Superiority or Other||Difference in Disease Control Rates|-4.5|||||2-Sided|95.0|-10.6|1.5|||||The difference was calculated as the percentage of participants with disease control in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.||
1670802|NCT01374425|3074424|Superiority or Other||Difference in Disease Control Rates|2.3|||||2-Sided|95.0|-3.7|8.3|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.||
1670803|NCT01374425|3074425|Superiority or Other||Difference in Disease Control Rates|-8.7|||||2-Sided|95.0|-19.1|1.7|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.||
1670804|NCT01374425|3074426|Superiority or Other||Difference in Disease Control Rates|2.1|||||2-Sided|95.0|-7.6|3.3|||||The difference was calculated as the percentage of participants with disease control in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.||
1670805|NCT01374425|3074427|Superiority or Other||Difference in Objective Response Rates|-3.7|||||2-Sided|95.0|-14.0|6.6|||||The difference was calculated as the percentage of participants with objective response in the ERCC-1 High subgroup minus the ERCC-1 Low subgroup. The 95% CI was computed using normal approximation to the binomial distribution.||
1670806|NCT01374425|3074428|Superiority or Other||Difference in Objective Response Rates|2.1|||||2-Sided|95.0|-9.9|14.1|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.||
1670807|NCT01374425|3074429|Superiority or Other||Difference in Objective Response Rates|9.4|||||2-Sided|95.0|7.2|26.1|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.||
1670808|NCT01374425|3074430|Superiority or Other||Difference in Objective Response Rates|4.3|||||2-Sided|95.0|-5.5|14.0|||||The difference was calculated as the percentage of participants with objective response in the Bevacizumab + FOLFIRI arm minus the Bevacizumab + mFOLFOX6 arm. The 95% CI was computed using normal approximation to the binomial distribution.||
1670809|NCT01374425|3074431|Superiority or Other||Hazard Ratio (HR)|1.19||||0.2774|2-Sided|95.0|0.87|1.62||P-value (relative to ERCC-1 Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to ERCC-1 Low subgroup) was estimated by Cox regression.|Analysis stratified by region of enrollment.|
1670810|NCT01374425|3074432|Superiority or Other||Hazard Ratio (HR)|0.74||||0.1519|2-Sided|95.0|0.49|1.12||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.|
1670811|NCT01374425|3074433|Superiority or Other||Hazard Ratio (HR)|0.8||||0.3295|2-Sided|95.0|0.51|1.26||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.|
1670812|NCT01374425|3074434|Superiority or Other||Hazard Ratio (HR)|0.76||||0.0861|2-Sided|95.0|0.56|1.04||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.|
1670813|NCT01374425|3074435|Superiority or Other||Hazard Ratio (HR)|0.65||||0.0647|2-Sided|95.0|0.41|1.03||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.|
1670814|NCT01374425|3074436|Superiority or Other||Hazard Ratio (HR)|0.83||||0.4032|2-Sided|95.0|0.54|1.28||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.|
1670815|NCT01374425|3074437|Superiority or Other||Hazard Ratio (HR)|0.86||||0.6035|2-Sided|95.0|0.48|1.53||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.|
1670816|NCT01374425|3074438|Superiority or Other||Hazard Ratio (HR)|0.73||||0.3019|2-Sided|95.0|0.41|1.32||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.|
1670817|NCT01374425|3074439|Superiority or Other||Hazard Ratio (HR)|1.19||||0.1658|2-Sided|95.0|0.93|1.53||P-value (relative to VEGF-A Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to VEGF-A Low subgroup) was estimated by Cox regression.|Analysis stratified by high/low ERCC-1 level and region of enrollment.|
1670818|NCT01374425|3074440|Superiority or Other||Hazard Ratio (HR)|0.99||||0.9576|2-Sided|95.0|0.77|1.28||P-value (relative to ERCC-1 Low subgroup) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to ERCC-1 Low subgroup) was estimated by Cox regression.|Analysis stratified by region of enrollment.|
1670819|NCT01374425|3074441|Superiority or Other||Hazard Ratio (HR)|0.76||||0.0786|2-Sided|95.0|0.55|1.03||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.|
1670820|NCT01374425|3074442|Superiority or Other||Hazard Ratio (HR)|0.84||||0.3944|2-Sided|95.0|0.56|1.26||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||HR (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by region of enrollment.|
1670821|NCT01374425|3074443|Superiority or Other||Hazard Ratio (HR)|0.79||||0.0555|2-Sided|95.0|0.61|1.01||P-value (relative to Bevacizumab + mFOLFOX6) based on two-sided stratified log rank test and not adjusted for multiple comparisons.|Log Rank||Hazard ratio (HR) (relative to Bevacizumab + mFOLFOX6) was estimated by Cox regression.|Analysis stratified by high/low excision repair cross-complementing (ERCC)-1 level and region of enrollment.|
1670822|NCT01373931|3074524|Superiority or Other||Ratio of Geometric LS Mean|1.0||||||90.0|0.944|1.07|||||||
1670823|NCT01373931|3074524|Superiority or Other||Ratio of Geometric LS Mean|1.07||||||90.0|1.0|1.15|||||||
1670824|NCT01373931|3074525|Superiority or Other||Median Difference (Final Values)|0.0|||||2-Sided|90.0|-0.5|0.5|||||||
1670825|NCT01373931|3074525|Superiority or Other||Median Difference (Final Values)|-0.25|||||2-Sided|90.0|-0.73|0.51|||||||
1670826|NCT01373931|3074526|Superiority or Other||Ratio of Geometric LS Mean|0.914|||||2-Sided|90.0|0.842|0.991|||||||
1670827|NCT01373931|3074526|Superiority or Other||Ratio of Geometric LS Mean|0.976|||||2-Sided|90.0|0.907|1.05|||||||
1670828|NCT01373489|3074535|Superiority||Mean Difference (Final Values)|10.0|||<|0.05|2-Sided|95.0|||||ANCOVA||||
1670829|NCT01373450|3074536|Superiority or Other||Least Square Mean Difference|0.016||||0.0056|2-Sided|90.0|0.006|0.026|||t-test, 1 sided||||
1670830|NCT01373450|3074536|Superiority or Other||Least Square Mean Difference|0.007||||0.0163|2-Sided|90.0|0.002|0.012|||t-test, 1 sided||||
1670831|NCT01373450|3074536|Superiority or Other||Least Square Mean Difference|0.03|||<|0.001|2-Sided|90.0|0.021|0.038|||t-test, 1 sided||||
1670832|NCT01373450|3074536|Superiority or Other||Least Square Mean Difference|0.021|||<|0.001|2-Sided|90.0|0.015|0.026|||t-test, 1 sided||||
1670833|NCT01373450|3074537|Superiority or Other||Geometric Mean Ratio|0.75||||0.049|2-Sided|90.0|0.56|1.0|||t-test, 1 sided||||
1670834|NCT01373450|3074537|Superiority or Other||Geometric Mean Ratio|0.99||||0.473|2-Sided|90.0|0.85|1.16|||t-test, 1 sided||||
1670835|NCT01373450|3074537|Superiority or Other||Geometric Mean Ratio|0.58|||<|0.001|2-Sided|90.0|0.45|0.74|||t-test, 1 sided||||
1670836|NCT01373450|3074537|Superiority or Other||Geometric Mean Ratio|0.77|||<|0.003|2-Sided|90.0|0.66|0.9|||t-test, 1 sided||||
1670837|NCT01373450|3074538|Superiority or Other||Intraclass Correlation Coefficient|0.92|||||2-Sided|90.0|0.72|0.98|||||||
1670838|NCT01373450|3074539|Superiority or Other||Least Square Mean Difference|0.014|||<|0.001|2-Sided|90.0|0.008|0.019|||t-test, 1 sided||||
1670839|NCT01373450|3074540|Superiority or Other||Geometric Mean Ratio|0.77||||0.004|2-Sided|90.0|0.66|0.9|||t-test, 1 sided||||
1670840|NCT01373450|3074541|Superiority or Other||Geometric Mean Ratio|0.87||||0.024|2-Sided|90.0|0.77|0.98|||t-test, 1 sided||||
1670841|NCT01373281|3074572|Superiority or Other||Vaccine Efficacy|54.8|||||2-Sided|95.0|46.8|61.7||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.|
1670842|NCT01373281|3074573|Superiority or Other||Vaccine Efficacy|57.9|||||2-Sided|95.0|49.0|65.2||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.|
1670843|NCT01373281|3074574|Superiority or Other||Vaccine Efficacy|55.4|||||2-Sided|95.0|47.3|62.3||||||The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy (expressed in %) calculated using the exact method conditional on the total number of cases in both groups.|
1670844|NCT01373281|3074577|Superiority or Other||Vaccine efficacy|56.5|||||2-Sided|95.0|43.8|66.4||||||The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy (expressed in %). The CI was calculated using the exact method conditional on the total number of cases in both groups (exact method by Breslow & Day). The vaccine efficacy of the CYD dengue vaccine was considered significant if the lower bound of its 95% CI was greater than 25%.|
1670845|NCT01373164|3074604|Superiority|The planned primary analysis for this study utilized a Bayesian exponential-likelihood model, incorporating historical overall survival (OS) data from 2 studies (Oettle et al. 2005; Saif et al. 2009). The primary analysis was performed using strong borrowing from the historical data. The model was estimated to borrow approximately 37 events from the historical studies.|Hazard Ratio (HR)|0.794|||||2-Sided|95.0|0.59|1.085|||||This is a Credible Interval estimated from the Bayesian analysis.||
1670847|NCT01372774|3074634|Superiority|||||||0.00068||||||Intracranial Brain Control Rates estimated via 1-Cumulative Incidence Rate from Competing Risk survival analysis of time to the specific recurrence type. Deaths without recurrence are censored at time of death.|Gray's K-sample||||
1670848|NCT01372774|3074635|Superiority||Hazard Ratio (HR)|1.07||||0.7|2-Sided|95.0|0.76|1.5|||Log Rank||||
1670849|NCT01372774|3074636|Superiority||Hazard Ratio (HR)|0.47|||<|0.0001|2-Sided|95.0|0.35|0.63|||Log Rank||||
1670850|NCT01372462|3074655|Superiority or Other||||||<|0.05|||||||ANOVA||||
1670851|NCT01372462|3074655|Superiority or Other||||||<|0.05|||||||ANOVA||||
1670852|NCT01372462|3074655|Superiority or Other||||||<|0.05||||||One-way, repeated-measures ANOVA and Newman-Keuls multiple comparisons tests|ANOVA|Newman-Keuls multiple comparisons tests||Per protocol|
1670853|NCT01372462|3074656|Superiority or Other||||||<|0.05|||||||ANOVA||||
1670854|NCT01372462|3074656|Superiority or Other||||||<|0.05|||||||ANOVA||||
1670855|NCT01372462|3074656|Superiority or Other||||||<|0.05|||||||ANOVA|Newman-Keuls multiple comparisons test||One-way, repeated-measures ANOVA and Newman-Keuls multiple comparisons test|
1670856|NCT01372462|3074657|Superiority or Other||||||<|0.05|||||||ANOVA||||
1670857|NCT01372462|3074657|Superiority or Other||||||<|0.05|||||||ANOVA||||
1670858|NCT01372462|3074657|Superiority or Other||||||<|0.05|||||||ANOVA|Newman-Keuls multiple comparisons test||The primary endpoint was difference in endurance between nasal cannula oxygen and NIOV+O2. Assuming 153 sec clinically important difference, 183 sec SD, and α=0.05, a sample size of 15 yielded 85% power.|
1670859|NCT01372410|3074658|Superiority or Other||Mean Difference (Final Values)|0.101|||<|0.001|2-Sided|95.0|0.045|0.157|||Mixed Models Analysis||||
1670860|NCT01372410|3074658|Superiority or Other||Mean Difference (Final Values)|0.139|||<|0.001|2-Sided|95.0|0.083|0.196|||Mixed Models Analysis||||
1670861|NCT01372410|3074658|Superiority or Other||Mean Difference (Final Values)|0.125|||<|0.001|2-Sided|95.0|0.069|0.182|||Mixed Models Analysis||||
1670862|NCT01372410|3074658|Superiority or Other||Mean Difference (Final Values)|0.183|||<|0.001|2-Sided|95.0|0.127|0.239|||Mixed Models Analysis||||
1670863|NCT01372410|3074658|Superiority or Other||Mean Difference (Final Values)|0.124|||<|0.001|2-Sided|95.0|0.068|0.179|||Mixed Models Analysis||||
1670864|NCT01372410|3074658|Superiority or Other||Mean Difference (Final Values)|0.101|||<|0.001|2-Sided|95.0|0.045|0.158|||Mixed Models Analysis||||
1670865|NCT01372410|3074658|Superiority or Other||Mean Difference (Final Values)|0.113|||<|0.001|2-Sided|95.0|0.058|0.168|||Mixed Models Analysis||||
1670866|NCT01372410|3074659|Superiority or Other||||||<|0.0001||||||Pooled Day 7 and 8 analysis.|Wald Test||||
1670867|NCT01372410|3074659|Superiority or Other||||||<|0.0001||||||Day 8 analysis.|Wald Test||||
1670868|NCT01372384|3074666|Superiority or Other|||||||0.274|||||||Clopper-Pearson “exact” method|||Response assessment of Partial Response Vs Progression of disease at Visit 10 (Two proportions for of Partial Response Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Partial Response Vs Progression of disease was analyzed|
1670869|NCT01372384|3074666|Superiority or Other|||||||1|||||||Clopper-Pearson “exact” method|||Response assessment of Stable Disease Vs Progression of disease at Visit 6 (Two proportions for of Stable Disease Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Stable Disease Vs Progression of disease was analyzed|
1670870|NCT01372384|3074666|Superiority or Other|||||||1|||||||Clopper-Pearson “exact” method|||Response assessment of Partial Response Vs Progression of disease at Visit 6 (Two proportions for of Partial Response Vs Progression of disease of Erlotinib): The observed significance value of performed test for differences between two proportions for of Partial Response Vs Progression of disease was analyzed|
1670871|NCT01372384|3074666|Superiority or Other|||||||1|||||||Clopper-Pearson “exact” method|||Response assessment of Stable Disease Vs Partial Response at Visit 6 (Two proportions for Stable Disease Vs Partial Response of Erlotinib): The observed significance value of performed test for differences between two proportions for Stable Disease Vs Partial Response was analyzed|
1670872|NCT01372384|3074666|Superiority or Other|||||||0.045|||||||Clopper-Pearson “exact” method|||Response assessment of Stable Disease Vs Partial Response at Visit 4 (Two proportions for Stable Disease Vs Partial Response of Erlotinib): The observed significance value of performed test for differences between two proportions for Stable Disease Vs Partial Response was analyzed.|
1670873|NCT01372150|3074672|Superiority or Other||Odds Ratio (OR)|0.751||||0.343|2-Sided|95.0|0.415|1.357|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 8|
1670874|NCT01372150|3074672|Superiority or Other||Odds Ratio (OR)|0.465||||0.017|2-Sided|95.0|0.249|0.871|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 8|
1670875|NCT01372150|3074672|Superiority or Other||Odds Ratio (OR)|0.64||||0.135|2-Sided|95.0|0.356|1.149|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 6|
1670876|NCT01372150|3074672|Superiority or Other||Odds Ratio (OR)|0.579||||0.072|2-Sided|95.0|0.319|1.05|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 6|
1670877|NCT01372150|3074672|Superiority or Other||Odds Ratio (OR)|0.663||||0.157|2-Sided|95.0|0.376|1.171|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 4|
1670878|NCT01372150|3074672|Superiority or Other||Odds Ratio (OR)|0.748||||0.313|2-Sided|95.0|0.426|1.314|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Flouxetine versus Placebo - Week 4|
1671047|NCT01370655|3074842|Superiority or Other||Difference in LS means|-4.8|||||2-Sided|90.0|-9.0|-0.5|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean||
1670879|NCT01372150|3074672|Superiority or Other||Odds Ratio (OR)|0.732||||0.272|2-Sided|95.0|0.419|1.277|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 3|
1670880|NCT01372150|3074672|Superiority or Other||Odds Ratio (OR)|0.688||||0.194|2-Sided|95.0|0.391|1.21|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 3|
1670881|NCT01372150|3074672|Superiority or Other||Odds Ratio (OR)|0.726||||0.297|2-Sided|95.0|0.399|1.324|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 2|
1670882|NCT01372150|3074672|Superiority or Other||Odds Ratio (OR)|0.795||||0.462|2-Sided|95.0|0.431|1.465|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 2|
1670883|NCT01372150|3074672|Superiority or Other||Odds Ratio (OR)|0.99||||0.984|2-Sided|95.0|0.382|2.567|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|DVS SR versus Placebo - Week 1|
1670884|NCT01372150|3074672|Superiority or Other||Odds Ratio (OR)|0.55||||0.186|2-Sided|95.0|0.226|1.335|||Regression, Logistic||Logistic Regression using Response (Y/N) at each time point (excluding Week 9) as a response variable and treatment, age group and country as factors.|Fluoxetine versus Placebo - Week 1|
1670885|NCT01372150|3074673|Superiority or Other|||||||0.852||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 8|
1670886|NCT01372150|3074673|Superiority or Other|||||||0.095||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 8|
1670887|NCT01372150|3074673|Superiority or Other|||||||0.266||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 6|
1670888|NCT01372150|3074673|Superiority or Other|||||||0.051||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 6|
1670889|NCT01372150|3074673|Superiority or Other|||||||0.187||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 4|
1670890|NCT01372150|3074673|Superiority or Other|||||||0.577||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 4|
1670891|NCT01372150|3074673|Superiority or Other|||||||0.659||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 3|
1670892|NCT01372150|3074673|Superiority or Other|||||||0.314||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 3|
1670893|NCT01372150|3074673|Superiority or Other|||||||0.113||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 2|
1670894|NCT01372150|3074673|Superiority or Other|||||||0.214||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 2|
1670895|NCT01372150|3074673|Superiority or Other|||||||0.698||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||DVS SR versus Placebo - Week 1|
1670896|NCT01372150|3074673|Superiority or Other|||||||0.924||||||"P-value obtained from the Cochran-Mantel-Haenszel test for the alternative hypothesis of Row Mean Scores Differences."|Cochran-Mantel-Haenszel|||Fluoxetine versus Placebo - Week 1|
1670897|NCT01372150|3074674|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.944|2-Sided|95.0|-0.29|0.27|||MMRM||Adjusted mean difference = Placebo - DVS SR|DVS SR versus Placebo|
1670898|NCT01372150|3074674|Superiority or Other||Mean Difference (Final Values)|0.18||||0.224|2-Sided|95.0|-0.11|0.46|||MMRM||Adjusted mean difference = Placebo - Fluoxetine|Fluoxetine versus Placebo|
1670899|NCT01372150|3074675|Superiority or Other||Mean Difference (Final Values)|-0.47||||0.739|2-Sided|95.0|-3.23|2.3|||MMRM||Adjusted mean difference = Placebo - DVS SR|DVS SR versus Placebo|
1670900|NCT01372150|3074675|Superiority or Other||Mean Difference (Final Values)|1.71||||0.226|2-Sided|95.0|-1.06|4.48|||Mixed-effects model for repeated measure|Mixed-effects model for repeated measures (MMRM)|Adjusted mean difference = placebo - fluoxetine|Fluoxetine versus Placebo|
1670901|NCT01371994|3074681|Superiority or Other|||||||0.27|||||||Log Rank|Based on a Log-rank test stratified by (pooled) center.|||
1670902|NCT01371994|3074682|Superiority or Other||Treatment Difference|0.4|Standard Error of the Mean|2.36||0.8507|2-Sided|95.0|-4.21|5.1|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis|
1670903|NCT01371994|3074682|Superiority or Other||Treatment Difference|2.0|Standard Error of the Mean|2.46||0.4067|2-Sided|95.0|-2.8|6.89|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12|
1670904|NCT01371994|3074684|Superiority or Other||Treatment Difference|1.1|Standard Error of the Mean|2.83||0.698|2-Sided|95.0|-4.5|6.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis|
1670905|NCT01371994|3074684|Superiority or Other||Treatment Difference|3.3|Standard Error of the Mean|2.81||0.2402|2-Sided|95.0|-2.26|8.91|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12|
1670906|NCT01371994|3074686|Superiority or Other||Treatment Difference|1.0|Standard Error of the Mean|2.47||0.6959|2-Sided|95.0|-3.92|5.85|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis|
1670907|NCT01371994|3074686|Superiority or Other||Treatment Difference|2.0|Standard Error of the Mean|2.43||0.4126|2-Sided|95.0|-2.82|6.81|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12|
1670908|NCT01371994|3074688|Superiority or Other||Treatment Difference|-2.4|Standard Error of the Mean|2.86||0.395|2-Sided|95.0|-8.1|3.21|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis|
1670909|NCT01371994|3074688|Superiority or Other||Treatment Difference|-0.3|Standard Error of the Mean|1.98||0.8876|2-Sided|95.0|-4.19|3.63|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12|
1670910|NCT01371994|3074690|Superiority or Other||Treatment Difference|0.6|Standard Error of the Mean|0.34||0.1038|2-Sided|95.0|-0.11|1.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis|
1670911|NCT01371994|3074690|Superiority or Other||Treatment Difference|0.5|Standard Error of the Mean|0.35||0.1279|2-Sided|95.0|-0.16|1.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12|
1670912|NCT01371994|3074692|Superiority or Other||Treatment Difference|0.2|Standard Error of the Mean|0.13||0.1499|2-Sided|95.0|-0.07|0.44|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis|
1670913|NCT01371994|3074692|Superiority or Other||Treatment Difference|0.2|Standard Error of the Mean|0.14||0.1493|2-Sided|95.0|-0.07|0.47|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12|
1670914|NCT01371994|3074694|Superiority or Other||Treatment Difference|0.3|Standard Error of the Mean|0.43||0.4521|2-Sided|95.0|-0.52|1.17|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison of end of treatment analysis|
1670915|NCT01371994|3074694|Superiority or Other||Treatment Difference|0.3|Standard Error of the Mean|0.46||0.5186|2-Sided|95.0|-0.6|1.19|||ANCOVA|Based on an analysis of covariance (ANCOVA) model including Baseline value as a covariates and fixed effects for (pooled) center and treatment.||Comparison at Week 12|
1670916|NCT01371994|3074696|Superiority or Other||Treatment Difference|0.3|Standard Error of the Mean|0.13||0.0325|2-Sided|95.0|0.02|0.52|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison of end of treatment analysis|
1670917|NCT01371994|3074696|Superiority or Other||Treatment Difference|0.4|Standard Error of the Mean|0.15||0.0149|2-Sided|95.0|0.07|0.64|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 12|
1670918|NCT01371994|3074696|Superiority or Other||Treatment Difference|0.2|Standard Error of the Mean|0.14||0.0761|2-Sided|95.0|-0.03|0.52|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 8|
1670919|NCT01371994|3074696|Superiority or Other||Treatment Difference|0.1|Standard Error of the Mean|0.13||0.3604|2-Sided|95.0|-0.14|0.38|||ANCOVA|Based on an analysis of variance model including treatment and (pooled) center as fixed factors.||Comparison at Week 4|
1670920|NCT01371994|3074698|Superiority or Other|||||||0.039|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison of end of treatment analysis|
1670921|NCT01371994|3074698|Superiority or Other|||||||0.0592|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 12|
1670922|NCT01371994|3074698|Superiority or Other|||||||0.5761|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 8|
1670923|NCT01371994|3074698|Superiority or Other|||||||0.4833|||||||Cochran-Mantel-Haenszel|Cochran-Mental-Haenszel test stratified by (pooled) center||Comparison at Week 4|
1670924|NCT01371994|3074699|Superiority or Other|||||||0.1745|||||||Log Rank|Based on a Log-rank test stratified by (pooled) center and Baseline daily pad usage (≤ 3 and > 3).||The treatment difference in the primary efficacy variable was tested using a log-rank test stratified by (pooled) center and by Baseline daily pad usage (≤3 and >3) at a 2-sided significance level of 0.05.|
1670925|NCT01371851|3074703|Superiority or Other||Odds Ratio (OR)|1.0529||||0.05|2-Sided||||||Regression, Logistic|||The analysis was applied to urine data obtained at all time points during weeks 1-8.|
1670926|NCT01371838|3074706|Superiority or Other||Risk Difference (RD)|1.1|||||2-Sided|95.0|-2.4|4.5|||||CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.||
1670927|NCT01371838|3074707|Superiority or Other||Risk Difference (RD)|0.3|||||2-Sided|95.0|-2.5|3.0|||||CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.||
1670928|NCT01371838|3074708|Superiority or Other||Risk Difference (RD)|9.9|||||2-Sided|95.0|2.8|17.1|||||CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.||
1670929|NCT01371838|3074709|Superiority or Other||Risk Difference (RD)|13.0|||||2-Sided|95.0|6.8|19.2|||||CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.||
1670930|NCT01371838|3074710|Superiority or Other||Risk Difference (RD)|11.9|||||2-Sided|95.0|-2.2|25.8|||||CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.||
1670931|NCT01371838|3074711|Superiority or Other||Risk Difference (RD)|15.2|||||2-Sided|95.0|2.7|27.1|||||CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.||
1670932|NCT01371838|3074714|Superiority or Other||Risk Difference (RD)|11.9|||||2-Sided|95.0|-2.2|25.8|||||CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.||
1672136|NCT01355523|3076608|Superiority or Other|||||||0.907|||||||Wilcoxon (Mann-Whitney)||||
1670934|NCT01371838|3074716|Superiority or Other||Risk Difference (RD)|13.0|||||2-Sided|95.0|6.8|19.2|||||CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments. If lower limit of 95% CI for the risk difference was >0% superioirty was concluded in this population.||
1670935|NCT01371838|3074717|Superiority or Other||Risk Difference (RD)|8.5|||||2-Sided|95.0|1.8|15.4|||||CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.||
1670936|NCT01371838|3074718|Superiority or Other||Risk Difference (RD)|10.7|||||2-Sided|95.0|4.9|16.4|||||CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.||
1670937|NCT01371838|3074719|Non-Inferiority or Equivalence|A two-sided 95% CI for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated in CE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than –10% in CE Population. If non-inferioirity was achieved then a test of superioirty was conducted whereby if lower limit of 95% CI for the difference was >0% superioirty was concluded.|Risk Difference (RD)|9.9|||||2-Sided|95.0|2.8|17.1|||||CI for risk difference was estimated by 95% Miettinen and Nurminen CI without adjustments.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE in adult subjects with CABP.|
1670938|NCT01371786|3074732|Superiority or Other||Mean Difference (Final Values)|-12.92|||||2-Sided|95.0|-21.76|-4.09|||||Difference calculated as Mometasone minus Ciclesonide|No formal null hypothesis was stated or tested.Descriptive statistics only were calculated and presented. The sample size was determined outside of statistical considerations. The sample size of 10 subjects was sufficient to provide approximately 80% power to detect a difference of 25% between the two treatment groups in the percentage of nasal deposition approximately 2 minutes post dose, assuming a two-sided test evaluated at a significance level of 0.05, with a SD of the difference of 23.17%.|
1670939|NCT01371747|3074733|Superiority or Other||Percentage of Participants|93.3|||||2-Sided|95.0|68.1|99.8|||||2-sided 95% exact binomial CI||
1670940|NCT01371747|3074733|Superiority or Other||Percentage of Participants|89.5|||||2-Sided|95.0|66.9|98.7|||||2-sided 95% exact binomial CI||
1670941|NCT01371747|3074733|Superiority or Other||Percentage of Participants|86.7|||||2-Sided|95.0|59.5|98.3|||||2-sided 95% exact binomial CI||
1670942|NCT01371747|3074733|Superiority or Other||Percentage of Participants|88.9|||||2-Sided|95.0|75.9|96.3|||||2-sided 95% exact binomial CI||
1670943|NCT01371747|3074733|Superiority or Other||Percentage of Participants|81.6|||||2-Sided|95.0|68.0|91.2|||||2-sided 95% exact binomial CI||
1670944|NCT01371747|3074733|Superiority or Other||Percentage of Participants|86.3|||||2-Sided|95.0|73.7|94.3|||||2-sided 95% exact binomial CI||
1670945|NCT01371747|3074735|Superiority or Other||Percentage of Participants|77.3|||||2-Sided|95.0|54.6|92.2|||||2-sided 95% exact binomial CI||
1670946|NCT01371747|3074735|Superiority or Other||Percentage of Participants|91.7|||||2-Sided|95.0|73.0|99.0|||||2-sided 95% exact binomial CI||
1670947|NCT01371747|3074735|Superiority or Other||Percentage of Participants|79.2|||||2-Sided|95.0|57.8|92.9|||||2-sided 95% exact binomial CI||
1670948|NCT01371747|3074735|Superiority or Other||Percentage of Participants|81.3|||||2-Sided|95.0|69.5|89.9|||||2-sided 95% exact binomial CI||
1670949|NCT01371747|3074735|Superiority or Other||Percentage of Participants|90.8|||||2-Sided|95.0|81.0|96.5|||||2-sided 95% exact binomial CI||
1670950|NCT01371747|3074735|Superiority or Other||Percentage of Participants|95.2|||||2-Sided|95.0|86.7|99.0|||||2-sided 95% exact binomial CI||
1670951|NCT01371747|3074736|Superiority or Other||Percentage of Participants|95.5|||||2-Sided|95.0|77.2|99.9|||||2-sided 95% exact binomial CI||
1670952|NCT01371747|3074736|Superiority or Other||Percentage of Participants|95.8|||||2-Sided|95.0|78.9|99.9|||||2-sided 95% exact binomial CI||
1670953|NCT01371747|3074736|Superiority or Other||Percentage of Participants|91.7|||||2-Sided|95.0|73.0|99.0|||||2-sided 95% exact binomial CI||
1670954|NCT01371747|3074736|Superiority or Other||Percentage of Participants|98.4|||||2-Sided|95.0|91.6|100.0|||||2-sided 95% exact binomial CI||
1670955|NCT01371747|3074736|Superiority or Other||Percentage of Participants|100.0|||||2-Sided|95.0|94.5|100.0|||||2-sided 95% exact binomial CI||
1670956|NCT01371747|3074736|Superiority or Other||Percentage of Participants|100.0|||||2-Sided|95.0|94.3|100.0|||||2-sided 95% exact binomial CI||
1670957|NCT01371747|3074737|Superiority or Other||Mean Difference (Net)|0.58|||||2-Sided||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.|
1670958|NCT01371747|3074737|Superiority or Other||Mean Difference (Net)|0.39|||||2-Sided||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.|
1670959|NCT01371747|3074737|Superiority or Other||Mean Difference (Net)|0.41|||||2-Sided||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.|
1670960|NCT01371747|3074737|Superiority or Other||Mean Difference (Net)|0.3|||||2-Sided||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.|
1670961|NCT01371747|3074737|Superiority or Other||Mean Difference (Net)|0.22|||||2-Sided||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.|
1670962|NCT01371747|3074737|Superiority or Other||Mean Difference (Net)|0.36|||||2-Sided||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.|
1670963|NCT01371747|3074738|Superiority or Other||Mean Difference (Net)|-1.17|||||2-Sided||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.|
1670964|NCT01371747|3074738|Superiority or Other||Mean Difference (Net)|-0.96|||||2-Sided||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.|
1670965|NCT01371747|3074738|Superiority or Other||Mean Difference (Net)|-1.0|||||2-Sided||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.|
1670966|NCT01371747|3074738|Superiority or Other||Mean Difference (Net)|-0.5|||||2-Sided||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.|
1670967|NCT01371747|3074738|Superiority or Other||Mean Difference (Net)|-0.44|||||2-Sided||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.|
1670968|NCT01371747|3074738|Superiority or Other||Mean Difference (Net)|-0.54|||||2-Sided||||||||Estimated values were based on summary statistics.|Each starting dose group was compared to its baseline.|
1670969|NCT01371747|3074739|Superiority or Other||||||<|0.001||||||P-value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670970|NCT01371747|3074739|Superiority or Other||||||<|0.001||||||P-value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670971|NCT01371747|3074739|Superiority or Other||||||<|0.001||||||P-value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670972|NCT01371747|3074739|Superiority or Other||||||<|0.001||||||P-value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670973|NCT01371747|3074739|Superiority or Other||||||<|0.001||||||P-Value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670974|NCT01371747|3074739|Superiority or Other||||||<|0.001||||||P-Value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670975|NCT01371747|3074740|Superiority or Other||||||<|0.001||||||P-value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670976|NCT01371747|3074740|Superiority or Other||||||<|0.001||||||P-value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670977|NCT01371747|3074740|Superiority or Other||||||<|0.001||||||P-value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670978|NCT01371747|3074740|Superiority or Other||||||<|0.001||||||P-value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670979|NCT01371747|3074740|Superiority or Other||||||<|0.001||||||P-Value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670980|NCT01371747|3074740|Superiority or Other||||||<|0.001||||||P-Value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670981|NCT01371747|3074741|Superiority or Other||||||<|0.001||||||P-value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670982|NCT01371747|3074741|Superiority or Other||||||<|0.001||||||P-value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670983|NCT01371747|3074741|Superiority or Other||||||<|0.001||||||P-value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670984|NCT01371747|3074741|Superiority or Other||||||<|0.001||||||P-value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670985|NCT01371747|3074741|Superiority or Other||||||<|0.001||||||P-Value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670986|NCT01371747|3074741|Superiority or Other||||||<|0.001||||||P-value <0.001|ANCOVA|||Each starting dose group was compared to its baseline.|
1670987|NCT01371734|3074742|Superiority or Other||Odds Ratio (OR)|0.764||||0.342|2-Sided|95.0|0.438|1.331|||Regression, Logistic|||Week 8|
1670988|NCT01371734|3074742|Superiority or Other||Odds Ratio (OR)|0.974||||0.925|2-Sided|95.0|0.561|1.689|||Regression, Logistic|||Week 8|
1670989|NCT01371734|3074742|Superiority or Other||Odds Ratio (OR)|0.916||||0.751|2-Sided|95.0|0.531|1.579|||Regression, Logistic|||Week 6|
1670990|NCT01371734|3074742|Superiority or Other||Odds Ratio (OR)|0.714||||0.228|2-Sided|95.0|0.413|1.235|||Regression, Logistic|||Week 6|
1670991|NCT01371734|3074742|Superiority or Other||Odds Ratio (OR)|0.964||||0.893|2-Sided|95.0|0.564|1.646|||Regression, Logistic|||Week 4|
1670992|NCT01371734|3074742|Superiority or Other||Odds Ratio (OR)|0.708||||0.21|2-Sided|95.0|0.412|1.216|||Regression, Logistic|||Week 4|
1670993|NCT01371734|3074742|Superiority or Other||Odds Ratio (OR)|0.564||||0.048|2-Sided|95.0|0.32|0.995|||Regression, Logistic|||Week 3|
1670994|NCT01371734|3074742|Superiority or Other||Odds Ratio (OR)|0.713||||0.248|2-Sided|95.0|0.402|1.265|||Regression, Logistic|||Week 3|
1670995|NCT01371734|3074742|Superiority or Other||Odds Ratio (OR)|0.86||||0.599|2-Sided|95.0|0.489|1.511|||Regression, Logistic|||Week 2|
1670996|NCT01371734|3074742|Superiority or Other||Odds Ratio (OR)|0.939||||0.826|2-Sided|95.0|0.536|1.644|||Regression, Logistic|||Week 2|
1670997|NCT01371734|3074742|Superiority or Other||Odds Ratio (OR)|0.561||||0.172|2-Sided|95.0|0.245|1.285|||Regression, Logistic|||Week 1|
1670998|NCT01371734|3074742|Superiority or Other||Odds Ratio (OR)|0.806||||0.633|2-Sided|95.0|0.333|1.951|||Regression, Logistic|||Week 1|
1670999|NCT01371734|3074743|Superiority or Other|||||||0.462|||||||Cochran-Mantel-Haenszel|||Week 8|
1671000|NCT01371734|3074743|Superiority or Other|||||||0.696|||||||Cochran-Mantel-Haenszel|||Week 8|
1671001|NCT01371734|3074743|Superiority or Other|||||||0.407|||||||Cochran-Mantel-Haenszel|||Week 6|
1671002|NCT01371734|3074743|Superiority or Other|||||||0.475|||||||Cochran-Mantel-Haenszel|||Week 6|
1671003|NCT01371734|3074743|Superiority or Other|||||||0.887|||||||Cochran-Mantel-Haenszel|||Week 4|
1671004|NCT01371734|3074743|Superiority or Other|||||||0.254|||||||Cochran-Mantel-Haenszel|||Week 4|
1671005|NCT01371734|3074743|Superiority or Other|||||||0.105|||||||Chi-squared, Corrected|||Week 3|
1671006|NCT01371734|3074743|Superiority or Other|||||||0.31|||||||Cochran-Mantel-Haenszel|||Week 3|
1671007|NCT01371734|3074743|Superiority or Other|||||||0.475|||||||Cochran-Mantel-Haenszel|||Week 2|
1671008|NCT01371734|3074743|Superiority or Other|||||||0.765|||||||Cochran-Mantel-Haenszel|||Week 2|
1671009|NCT01371734|3074743|Superiority or Other|||||||0.756|||||||Cochran-Mantel-Haenszel|||Week 1|
1671010|NCT01371734|3074743|Superiority or Other|||||||0.729|||||||Cochran-Mantel-Haenszel|||Week 1|
1671011|NCT01371734|3074744|Superiority or Other||Mean Difference (Net)|0.161||||0.302|2-Sided|95.0|-0.14|0.47|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR High Dose|
1671012|NCT01371734|3074744|Superiority or Other||Mean Difference (Net)|0.015||||0.923|2-Sided|95.0|-0.29|0.32|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR Low Dose|
1671013|NCT01371734|3074745|Superiority or Other||Mean Difference (Net)|1.52||||0.333|2-Sided|95.0|-1.56|4.61|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR High Dose|
1672137|NCT01355523|3076609|Superiority or Other|||||||0.122|||||||Wilcoxon (Mann-Whitney)||||
1671014|NCT01371734|3074745|Superiority or Other||Mean Difference (Net)|0.85||||0.587|2-Sided|95.0|-2.23|3.94|||Mixed-effects model for repeated measure|Hochberg procedure was used to control for multiplicity||Adjusted mean difference = Placebo - DVS SR Low Dose|
1671015|NCT01371006|3074811|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|54.31|Standard Deviation|44.2|||2-Sided|90.0|40.47|72.88|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir|
1671016|NCT01371006|3074812|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|64.97|Standard Deviation|30.2|||2-Sided|90.0|53.32|79.16|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir|
1671017|NCT01371006|3074813|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|71.83|Standard Deviation|23.6|||2-Sided|90.0|61.46|83.95|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz : 7.5 mg Midazolam+240 mg Faldaprevir) of Faldaprevir|
1671018|NCT01371006|3074814|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|116.12|Standard Deviation|18.8|||2-Sided|90.0|101.87|132.35|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz|
1671019|NCT01371006|3074815|Non-Inferiority or Equivalence|investigation of relative bioavailability (no formal testing)|Geometric Mean Ratio|105.61|Standard Deviation|22.0|||2-Sided|90.0|90.81|122.82|||||the standard deviation is actually the geometric coefficient of variation|relative bioavailability comparison (50 mg Efavirenz+240 mg Faldaprevir : 50 mg Efavirenz) of Efavirenz|
1671020|NCT01370863|3074816|Superiority or Other||Difference in LS means|-0.087||||0.637|2-Sided|95.0|-0.501|0.326|||ANCOVA||||
1671021|NCT01370863|3074817|Superiority or Other||Diference in LS means|0.264||||0.487|2-Sided|95.0|-0.495|1.024|||ANCOVA||||
1671022|NCT01370863|3074818|Superiority or Other||Difference in LS Mean|-1.452||||0.869|2-Sided|95.0|-19.054|16.149|||ANCOVA||||
1671023|NCT01370837|3074819|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Arm vs foot|
1671024|NCT01370837|3074819|Superiority or Other||||||<|0.27|||||||Wilcoxon (Mann-Whitney)|||Arm vs foot|
1671025|NCT01370837|3074819|Superiority or Other||||||<|0.25|||||||Wilcoxon (Mann-Whitney)|||Arm vs foot|
1671026|NCT01370837|3074819|Superiority or Other||||||<|0.07|||||||Kruskal-Wallis|||Foot|
1671027|NCT01370837|3074819|Superiority or Other||||||<|0.53|||||||Kruskal-Wallis|||Arm|
1671028|NCT01370837|3074819|Superiority or Other||||||<|0.76|||||||Kruskal-Wallis|||Foot|
1671029|NCT01370837|3074819|Superiority or Other||||||<|0.84|||||||Kruskal-Wallis|||Arm|
1671030|NCT01370655|3074836|Superiority or Other||Difference in LS means|5.0|||||2-Sided|90.0|-7.7|17.6|||||HCTZ 25 mg LS mean minus Placebo LS mean||
1671031|NCT01370655|3074836|Superiority or Other||Difference in LS means|-3.9|||||2-Sided|90.0|-15.0|7.2|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean||
1671032|NCT01370655|3074836|Superiority or Other||Difference in LS means|3.0|||||2-Sided|90.0|-9.6|15.6|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean||
1671033|NCT01370655|3074836|Non-Inferiority or Equivalence|If the upper bound of the two-sided 80% CI (equivalent to a one-sided upper 90% CI) for the difference is <13 mmol/day the hypothesis will be supported for the 3-mg dose and testing will continue with construction of a two-sided 80% CI for the 6-mg dose (6 mg MK-7145 – placebo). The hypothesis will be supported if one or both doses meet the test criterion.|Difference in LS means|1.1|||||2-Sided|80.0|-8.5|10.7|||||MK-7145 6 mg LS mean minus Placebo LS mean||
1671034|NCT01370655|3074836|Non-Inferiority or Equivalence|If the upper bound of the two-sided 80% CI (equivalent to a one-sided upper 90% CI) for the difference is <13 mmol/day the hypothesis will be supported for the 3-mg dose and testing will continue with construction of a two-sided 80% CI for the 6-mg dose (6 mg MK-7145 – placebo). The hypothesis will be supported if one or both doses meet the test criterion.|Difference in LS means|7.9|||||2-Sided|80.0|-2.3|18.2|||||MK-7145 3 mg LS mean minus Placebo LS mean||
1671035|NCT01370655|3074840|Superiority or Other||Difference in LS means|94.6|||||2-Sided|90.0|58.8|130.4|||||HCTZ 25 mg LS mean minus Placebo LS mean||
1671036|NCT01370655|3074840|Superiority or Other||Difference in LS means|30.9|||||2-Sided|90.0|-7.0|68.7|||||MK-7145 3 mg LS mean minus Placebo LS mean||
1671037|NCT01370655|3074840|Superiority or Other||Difference in LS means|-18.1|||||2-Sided|90.0|-49.1|12.9|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean||
1671038|NCT01370655|3074840|Superiority or Other||Difference in LS means|-63.7|||||2-Sided|90.0|-100.8|-26.7|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean||
1671039|NCT01370655|3074840|Non-Inferiority or Equivalence|Hypothesis supported if the lower bound of the two-sided 80% CI (equivalent to a one-sided lower 90% CI) is > 89.0 mmol/day.|Difference in LS means|76.5|||||2-Sided|80.0|49.2|103.8|||||MK-7145 6 mg LS mean minus Placebo LS mean|Type I error rate of alpha=0.10 (1-sided) is specified for testing of the hypothesis.|
1671040|NCT01370655|3074841|Superiority or Other||Difference in LS means|-0.3|||||2-Sided|90.0|-3.3|2.7|||||HCTZ 25 mg LS mean minus Placebo LS mean||
1671041|NCT01370655|3074841|Superiority or Other||Difference in LS means|-3.4|||||2-Sided|90.0|-6.5|-0.2|||||MK-7145 3 mg LS mean minus Placebo LS mean||
1671042|NCT01370655|3074841|Superiority or Other||Difference in LS means|-3.0|||||2-Sided|90.0|-6.0|-0.1|||||MK-7145 3 mg LS mean minus HCTZ 25 mg LS mean||
1671043|NCT01370655|3074841|Superiority or Other||Difference in LS means|-2.9|||||2-Sided|90.0|-5.5|-0.2|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean||
1671044|NCT01370655|3074841|Superiority or Other||Difference in LS means|-3.2|||||2-Sided|90.0|-6.1|-0.3|||||MK-7145 6 mg LS mean minus Placebo LS mean||
1671045|NCT01370655|3074842|Superiority or Other||Difference in LS Means|-1.9|||||2-Sided|90.0|-6.2|2.3|||||HCTZ 25 mg LS mean minus Placebo LS mean||
1671046|NCT01370655|3074842|Superiority or Other||Difference in LS Means|-6.7|||||2-Sided|90.0|-11.2|-2.2|||||MK-7145 3 mg LS mean minus Placebo LS mean||
1671048|NCT01370655|3074842|Non-Inferiority or Equivalence|Hypothesis supported if the upper bound of the two-sided 90% CI (equivalent to a one-sided upper 95% CI) for the difference ≤ 3.8 mmHg.|Difference in LS means|-5.4|||||2-Sided|90.0|-9.2|-1.6|||||MK-7145 6 mg LS mean minus HCTZ 25 mg LS mean|Type I error rate of alpha=0.05 (1-sided) is specified for testing of the hypothesis.|
1671049|NCT01370655|3074842|Non-Inferiority or Equivalence|"Hypothesis supported if the upper bound of the two-sided 80% confidence interval (CI; equivalent to a one-sided upper 90% CI) is~≤0 mmHg"|Difference in Least square (LS) means|-7.4|||||2-Sided|80.0|-10.6|-4.1|||||MK-7145 6 mg LS mean minus Placebo LS mean|Type I error rate of alpha=0.10 (1-sided) is specified for testing of the hypothesis.|
1671050|NCT01370642|3074844|Superiority or Other||LS Mean Difference at Week 24|-0.9|||||2-Sided|95.0|-1.2|-0.6||||||Change from BL in HCV RNA at Week 24 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.|
1671051|NCT01370642|3074844|Superiority or Other||LS Mean Difference at Week 24|-0.8|||||2-Sided|95.0|-1.1|-0.5||||||Change from BL in HCV RNA at Week 24 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.|
1671052|NCT01370642|3074844|Superiority or Other||LS Mean Difference at Week 12|-1.4|||||2-Sided|95.0|-1.7|-1.1||||||Change from BL in HCV RNA at Week 12 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.|
1671053|NCT01370642|3074844|Superiority or Other||LS Mean Difference at Week 12|-1.4|||||2-Sided|95.0|-1.7|-1.1||||||Change from BL in HCV RNA at Week 12 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.|
1671054|NCT01370642|3074844|Superiority or Other||LS Mean Difference at Week 8|-2.0|||||2-Sided|95.0|-2.3|-1.7||||||Change from BL in HCV RNA at Week 8 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.|
1671055|NCT01370642|3074844|Superiority or Other||LS Mean Difference at Week 8|-1.9|||||2-Sided|95.0|-2.2|-1.6||||||Change from BL in HCV RNA at Week 8 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.|
1671056|NCT01370642|3074844|Superiority or Other||LS Mean Difference at Week 4|-3.1|||||2-Sided|95.0|-3.4|-2.8||||||Change from BL in HCV RNA at Week 4 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.|
1671057|NCT01370642|3074844|Superiority or Other||LS Mean Difference at Week 4|-3.0|||||2-Sided|95.0|-3.3|-2.7||||||Change from BL in HCV RNA at Week 4 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.|
1671058|NCT01370642|3074844|Superiority or Other||LS Mean Difference at Week 2|-3.5|||||2-Sided|95.0|-3.7|-3.2||||||Change from BL in HCV RNA at Week 2 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.|
1671059|NCT01370642|3074844|Superiority or Other||LS Mean Difference at Week 2|-3.2|||||2-Sided|95.0|-3.5|-3.0||||||Change from BL in HCV RNA at Week 2 was computed using a constrained longitudinal data analysis model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups as well as adjusting for IL28B and age, and their interaction terms with time will be included in the model.|
1671060|NCT01370642|3074845|Superiority or Other||Difference in percentages|0.5||||0.942|2-Sided|95.0|-13.4|14.4|||Miettinen and Nurminen method|||Difference in percentage of participants with neutropenia Tier 1 AEs between vaniprevir and control.|
1671061|NCT01370642|3074845|Superiority or Other||Difference in percentages|8.2||||0.252|2-Sided|95.0|-5.8|21.8|||Miettinen and Nurminen method|||Difference in percentage of participants with neutropenia Tier 1 AEs between vaniprevir and control.|
1671062|NCT01370642|3074845|Superiority or Other||Difference in percentages|5.6||||0.432|2-Sided|95.0|-8.4|19.4|||Miettinen and Nurminen method|||Difference in percentage of participants with GI Tier 1 AEs between vaniprevir and control.|
1671063|NCT01370642|3074845|Superiority or Other||Difference in percentages|15.3||||0.032|2-Sided|95.0|1.3|28.7|||Miettinen and Nurminen method|||Difference in percentage of participants with GI Tier 1 AEs between vaniprevir and control.|
1671064|NCT01370642|3074845|Superiority or Other||Difference in percentages|5.2||||0.22|2-Sided|95.0|-3.3|14.2|||Miettinen and Nurminen method|||Difference in percentage of participants with bilirubin increased Tier 1 AEs between vaniprevir and control.|
1671065|NCT01370642|3074845|Superiority or Other||Difference in percentages|0.0|||>|0.999|2-Sided|95.0|-7.9|7.9|||Miettinen and Nurminen method|||Difference in percentage of participants with bilirubin increased Tier 1 AEs between vaniprevir and control.|
1671066|NCT01370642|3074845|Superiority or Other||Difference in percentages|-12.7|||>|0.072|2-Sided|95.0|-26.2|1.2|||Miettinen and Nurminen method|||Difference in percentage of participants with anemia Tier 1 AEs between vaniprevir and control.|
1671236|NCT01368042|3075216|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Deviation|16.5||0.67|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)||
1671067|NCT01370642|3074845|Superiority or Other||Difference in percentages|-4.1|||>|0.557|2-Sided|95.0|-17.5|9.5|||Miettinen and Nurminen method|||Difference in percentage of participants with anemia Tier 1 AEs between vaniprevir and control.|
1671068|NCT01370642|3074845|Superiority or Other||Difference in percentages|-2.2|||>|0.67|2-Sided|95.0|-12.6|8.1|||Miettinen and Nurminen method|||Difference in percentage of participants with ≥1 Tier 1 AEs between vaniprevir and control.|
1671069|NCT01370642|3074845|Superiority or Other||Difference in percentages|4.1|||>|0.385|2-Sided|95.0|-5.4|13.7|||Miettinen and Nurminen method|||Difference in percentage of participants with ≥1 Tier 1 AEs between vaniprevir and control.|
1671070|NCT01370642|3074846|Superiority or Other||Adjusted Difference in Percentages|17.8|||<|0.001|2-Sided|95.0|9.3|27.8|||Miettinen and Nurminen method|||To compare the percentage of participants achieving undetectable HCV RNA at EOT between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.|
1671071|NCT01370642|3074846|Superiority or Other||Adjusted Difference in Percentages|17.0|||<|0.001|2-Sided|95.0|8.1|27.3|||Miettinen and Nurminen method|||To compare the percentage of participants achieving undetectable HCV RNA at EOT between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.|
1671072|NCT01370642|3074847|Superiority or Other||Adjusted Difference in Percentages|49.6|||<|0.001|2-Sided|95.0|38.5|60.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving cEVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.|
1671073|NCT01370642|3074847|Superiority or Other||Adjusted Difference in Percentages|48.4|||<|0.001|2-Sided|95.0|37.2|58.9|||Miettinen and Nurminen method|||To compare the percentage of participants achieving cEVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.|
1671074|NCT01370642|3074848|Superiority or Other||Adjusted Difference in Percentages|76.7|||<|0.001|2-Sided|95.0|66.7|84.1|||Miettinen and Nurminen method|||To compare the percentage of participants achieving RVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.|
1671075|NCT01370642|3074848|Superiority or Other||Adjusted Difference in Percentages|78.1|||<|0.001|2-Sided|95.0|68.2|85.3|||Miettinen and Nurminen method|||To compare the percentage of participants achieving RVR between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.|
1671076|NCT01370642|3074849|Superiority or Other||Adjusted Difference in Percentages|29.6|||<|0.001|2-Sided|95.0|18.3|41.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR12 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.|
1671077|NCT01370642|3074849|Superiority or Other||Adjusted Difference in Percentages|30.0|||<|0.001|2-Sided|95.0|18.1|41.5|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR12 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.|
1671078|NCT01370642|3074850|Superiority or Other||Adjusted Difference in Percentages|28.6|||<|0.001|2-Sided|95.0|17.4|40.0|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR24 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by IL28B and age utilizing Cochran-Mantel-Haenszel weights.|
1671079|NCT01370642|3074850|Superiority or Other||Adjusted Difference in Percentages|29.0|||<|0.001|2-Sided|95.0|17.2|40.5|||Miettinen and Nurminen method|||To compare the percentage of participants achieving SVR24 between the vaniprevir and control arms, 95% confidence intervals and corresponding p-values for the between-treatment difference (vaniprevir - control) were computed using Miettinen and Nurminen method stratified by Interleukin 28B (IL28B) and age utilizing Cochran-Mantel-Haenszel weights.|
1671080|NCT01370616|3074856|Superiority or Other||Estimated Difference|-1.8|||||2-Sided|95.0|-5.7|1.9|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen & Nurminen method without adjusting strata.||
1671081|NCT01370616|3074857|Superiority or Other||Estimated Difference|1.8|||||2-Sided|95.0|-2.0|5.8|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen & Nurminen method without adjusting strata.||
1671082|NCT01370616|3074858|Superiority or Other||Estimated Difference|-2.5|||||2-Sided|95.0|-8.5|3.4|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen & Nurminen method without adjusting strata.||
1671083|NCT01370616|3074859|Superiority or Other||Estimated Difference|7.3|||||2-Sided|95.0|-0.9|15.4|||||Ertapenem minus Piperacillin/tazobactam group. Based on Miettinen & Nurminen method without adjusting strata.||
1671084|NCT01370616|3074860|Superiority or Other||Estimated Difference|-4.3|||||2-Sided|95.0|-12.1|3.3|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen & Nurminen method stratified by the severity of diabetes foot infection.||
1671085|NCT01370616|3074861|Superiority or Other||Estimated Difference|-4.1|||||2-Sided|95.0|-11.9|3.4|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen & Nurminen method stratified by the severity of diabetes foot infection.||
1671086|NCT01370616|3074862|Superiority or Other||Estimated Difference|-2.3|||||2-Sided|95.0|-7.7|2.8|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen & Nurminen method stratified by the severity of diabetes foot infection.||
1671087|NCT01370616|3074863|Superiority or Other||Estimated Difference|-1.7|||||2-Sided|95.0|-5.5|1.8|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen & Nurminen method stratified by the severity of diabetes foot infection.||
1671088|NCT01370616|3074864|Non-Inferiority or Equivalence|If the 95% confidence interval for the estimated difference between the two groups has a lower bound greater than -15%, then ertapenem sodium will be considered at least as effective as piperacillin/tazobactam sodium.|Estimated Difference|-3.8|||||2-Sided|95.0|-8.3|0.0|||||Ertapenem minus Piperacillin/tazobactam. Based on Miettinen & Nurminen method stratified by the severity of diabetes foot infection.||
1671089|NCT01370603|3074865|Superiority or Other||Difference in Least-squares Means|0.0|||||2-Sided|97.5|-4.9|4.9|||||||
1671090|NCT01370603|3074866|Superiority or Other||Difference in Least-squares means|-0.5|||||2-Sided|97.5|-1.9|1.0|||||||
1671091|NCT01370603|3074867|Superiority or Other||Difference in Least-squares Means|-0.2|||||2-Sided|97.5|-1.7|1.4|||||||
1671092|NCT01370603|3074868|Superiority or Other||Difference in Least-squares means|-0.3|||||2-Sided|97.5|-1.8|1.2|||||||
1671093|NCT01370603|3074869|Superiority or Other||Difference in Least-squares means|-0.1|||||2-Sided|97.5|-1.4|1.2|||||||
1671094|NCT01370603|3074870|Non-Inferiority or Equivalence|Equivalence was declared if the 97.5% expanded confidence interval for the mean difference between the fixed-dose combination and co-administration in percent change from baseline was contained within ±4%.|Difference in Least-squares means|-0.2|||||2-Sided|97.5|-1.9|1.4||||||It was anticipated that 85% of the enrolled participants would be evaluable to achieve 95% power in order to establish equivalence between the Ezetimibe/Atorvastatin Fixed Dose Combination and the co-administration of Ezetimibe and Atorvastatin with respect to percent change from baseline in LDL-C after 6 weeks of treatment using two one-sided tests each at 2.5% α-level, assuming the underlying true treatment difference is ±1.08% and that the standard deviation of the difference is 12.8%.|
1671095|NCT01370590|3074871|Superiority or Other||Difference in least-squares means|1.6|||||2-Sided|97.5|-3.2|6.3||||||Analyses were based on log-transformed data.|
1671096|NCT01370590|3074872|Superiority or Other||Difference in least-squares means|0.7|||||2-Sided|97.5|-0.6|1.9|||||||
1671097|NCT01370590|3074873|Superiority or Other||Difference in least-squares means|0.0|||||2-Sided|97.5|-1.3|1.4|||||||
1671098|NCT01370590|3074874|Superiority or Other||Difference in Least-squares mean|0.8|||||2-Sided|97.5|-0.6|2.2|||||||
1671099|NCT01370590|3074875|Superiority or Other||Difference in Least-square means|0.3|||||2-Sided|97.5|-0.8|1.4|||||||
1671100|NCT01370590|3074876|Non-Inferiority or Equivalence|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet was considered equivalent to co-administration of ezetimibe 10 mg and atorvastatin 20 mg, if the two-sided 97.5% expanded confidence intervals of the treatment difference in least squares means for percent change in LDL-C from baseline after 6 weeks of treatment (combination minus co-administration) was contained within -4% and 4% (equivalence margins).|Difference in Least-square Means|-0.2|||||2-Sided|97.5|-1.7|3.3||||||It was anticipated that 85% of the enrolled participants would be evaluable to achieve 95% power in order to establish equivalence between the Ezetimibe/Atorvastatin Fixed Dose Combination and the co-administration of Ezetimibe and Atorvastatin with respect to percent change from baseline in LDL-C after 6 weeks of treatment using two one-sided tests each at 2.5% α-level, assuming the underlying true treatment difference is ±1.4% and that the standard deviation of the difference is 12.8%.|
1671101|NCT01370564|3074883|Other|There was no specific hypothesis tested. The method of Rao and Scott for clustered binary data was used to construct a point estimate and 95% confidence interval for the number of days during the follow-up period across all subjects in which the patient instruction set was based on the subject's pressure state as measured by the Chronicle IHM/ICD system.|Rao-Scott estimator for clustered data|72.0|||||2-Sided|95.0|65.0|78.0|||||||
1671102|NCT01370356|3074931|Superiority or Other||Odds Ratio (OR)|2.67|||<|0.0001|2-Sided|95.0|2.05|3.47||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.|
1671103|NCT01370356|3074932|Superiority or Other||Odds Ratio (OR)|2.66|||<|0.0001|2-Sided|95.0|2.05|3.44||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 52. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.|
1671104|NCT01370356|3074932|Superiority or Other||Odds Ratio (OR)|4.58|||<|0.0001|2-Sided|95.0|3.51|5.98||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 24. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.|
1671105|NCT01370356|3074932|Superiority or Other||Odds Ratio (OR)|8.69|||<|0.0001|2-Sided|95.0|6.03|12.51||Statistical test was 2-sided and a 0.05 level of significance was used.|Regression, Logistic|||Statistical analysis presented above is for Week 12. Analysis was done using logistic regression model with treatment effect as the explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model with treatment-by-center interaction. The inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of treatment by center interaction.|
1671233|NCT01368185|3075210|Superiority or Other||% change SUA from baseline|4.6|Standard Deviation|0.9|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 SUA minus baseline SUA.|Comparison between Month 3 and Baseline|
1671106|NCT01370356|3074933|Superiority or Other||Odds Ratio (OR)|4.02|||<|0.0001|2-Sided|95.0|2.94|5.5||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 – 24, 2) CA for Weeks 21 – 24, 3) CA for Weeks 21 – 52.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.|
1671107|NCT01370356|3074934|Superiority or Other||Odds Ratio (OR)|5.66|||<|0.0001|2-Sided|95.0|4.21|7.61||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 – 24, 2) CA for Weeks 21 – 24, 3) CA for Weeks 21 – 52.|Regression, Logistic|||Analysis was done using a logistic regression model including treatment effect as the explanatory variable and investigative center as covariate. In addition, the interaction effect was tested using an expanded logistic regression model including the treatment-by-center interaction. However, the inferences reported were based on the logistic regression model including only the main effects of treatment and center, regardless of the significance of the treatment by center interaction.|
1671108|NCT01370356|3074935|Superiority or Other||Odds Ratio (OR)|8.74|||<|0.0001|2-Sided|95.0|6.09|12.53||Statistical test was 2-sided and a 0.05 level of significance was used. A fixed-sequence procedure was used to adjust for multiplicity. Hierarchy of comparisons: 1) 10-week CA for Weeks 15 – 24, 2) CA for Weeks 21 – 24, 3) CA for Weeks 21 – 52.|Regression, Logistic|||Assuming true CA rate of 6.9% for placebo and 17.2% for varenicline (odds ratio ≥ 2.8), a study randomizing 1404 participants (1:1 ratio) has ≥90% power to detect a difference between the two groups. Analysis was done using a logistic regression model; treatment effect as explanatory variable and investigative center as covariate. The interaction effect was tested using an expanded logistic regression model including treatment-by-center interaction.|
1671109|NCT01370265|3074941|Superiority or Other|||||||0.08|||||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for diastolic blood pressure, alpha level of 0.05.|
1671110|NCT01370265|3074941|Superiority or Other|||||||0.31|||||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for systolic blood pressure, alpha level of 0.05.|
1671111|NCT01370265|3074942|Superiority or Other|||||||0.51|||||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for hyperemic heart rate, alpha level of 0.05.|
1671112|NCT01370265|3074942|Superiority or Other|||||||0.28|||||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for resting heart rate, alpha level of 0.05.|
1671113|NCT01370265|3074943|Superiority or Other|||||||0.13|||||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Lateral, alpha level of 0.05.|
1671114|NCT01370265|3074943|Superiority or Other|||||||0.96|||||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Inferior, alpha level of 0.05|
1671115|NCT01370265|3074943|Superiority or Other|||||||0.42|||||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for CFR Septum, alpha level of 0.05|
1671116|NCT01370265|3074943|Superiority or Other|||||||0.78|||||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention for CFR Anterior, alpha level of 0.05.|
1671117|NCT01370265|3074944|Superiority or Other|||||||0.74|||||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Lateral, alpha level of 0.05.|
1671118|NCT01370265|3074944|Superiority or Other|||||||0.44|||||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention)for Hyperemic MBF Inferior, alpha level of 0.05.|
1671119|NCT01370265|3074944|Superiority or Other|||||||0.13|||||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention) for Hyperemic MBF Septum, alpha level of 0.05.|
1671120|NCT01370265|3074944|Superiority or Other|||||||0.57|||||||t-test, 2 sided|||Statistical analysis comparing Regadenoson and Adenosine groups (per intervention), for Hyperemic MBF Anterior, alpha level of 0.05.|
1671121|NCT01370265|3074945|Superiority or Other|||||||0.21|||||||t-test, 2 sided|||Statistical analysis for Cardiac Flow Rate (CFR) between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05|
1671122|NCT01370265|3074947|Superiority or Other|||||||0.14|||||||t-test, 2 sided|||Statistical analysis for hyperemic global MBF between Regadenoson and Adenosine groups (per intervention), alpha level of 0.05.|
1671123|NCT01370005|3074959|Superiority or Other||Odds Ratio (OR)|2.2||||0.0088|2-Sided|95.0|1.22|3.96|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c|||
1671124|NCT01370005|3074959|Superiority or Other||Odds Ratio (OR)|2.49||||0.0021|2-Sided|95.0|1.39|4.45|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c|||
1671125|NCT01370005|3074960|Superiority or Other||Mean Difference (Final Values)|-1.89|Standard Error of the Mean|0.55||0.0006|2-Sided|95.0|-2.97|-0.82|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP|Difference calculated as empa 25mg minus placebo.||
1671126|NCT01370005|3074960|Superiority or Other||Mean Difference (Final Values)|-1.93|Standard Error of the Mean|0.55||0.0005|2-Sided|95.0|-3.01|-0.84|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated DBP|Difference calculated as empa 10mg minus placebo.||
1671127|NCT01370005|3074961|Superiority or Other||Mean Difference (Final Values)|-4.8|Standard Error of the Mean|0.98|<|0.0001|2-Sided|95.0|-6.73|-2.87|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP|Difference calculated as empa 25mg minus placebo.||
1671128|NCT01370005|3074961|Superiority or Other||Mean Difference (Final Values)|-3.92|Standard Error of the Mean|0.99|<|0.0001|2-Sided|95.0|-5.86|-1.98|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline seated SBP|Difference calculated as empa 10mg minus placebo.||
1671129|NCT01370005|3074962|Superiority or Other||Mean Difference (Final Values)|-1.15|Standard Error of the Mean|0.5||0.0208|2-Sided|95.0|-2.12|-0.18|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP|Difference calculated as empa 25mg minus placebo.||
1671130|NCT01370005|3074962|Superiority or Other||Mean Difference (Final Values)|-0.95|Standard Error of the Mean|0.5||0.0566|2-Sided|95.0|-1.93|0.03|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time DBP|Difference calculated as empa 10mg minus placebo.||
1671131|NCT01370005|3074963|Superiority or Other||Mean Difference (Final Values)|-2.9|Standard Error of the Mean|0.81||0.0003|2-Sided|95.0|-4.48|-1.32|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP|Difference calculated as empa 25mg minus placebo.||
1671132|NCT01370005|3074963|Superiority or Other||Mean Difference (Final Values)|-2.5|Standard Error of the Mean|0.81||0.0021|2-Sided|95.0|-4.09|-0.91|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline night-time SBP|Difference calculated as empa 10mg minus placebo.||
1671133|NCT01370005|3074964|Superiority or Other||Mean Difference (Final Values)|-1.98|Standard Error of the Mean|0.44|<|0.0001|2-Sided|95.0|-2.84|-1.12|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP|Difference calculated as empa 25mg minus placebo.||
1671134|NCT01370005|3074964|Superiority or Other||Mean Difference (Final Values)|-1.56|Standard Error of the Mean|0.44|<|0.0004|2-Sided|95.0|-2.42|-0.69|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime DBP|Difference calculated as empa 10mg minus placebo.||
1671135|NCT01370005|3074965|Superiority or Other||Mean Difference (Final Values)|-4.78|Standard Error of the Mean|0.72|<|0.0001|2-Sided|95.0|-6.2|-3.36|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline daytime SBP|Difference calculated as empa 25mg minus placebo.||
1671136|NCT01370005|3074965|Superiority or Other||Mean Difference (Final Values)|-3.94|Standard Error of the Mean|0.73|<|0.0001|2-Sided|95.0|-5.37|-2.52|||ANCOVA|Model includes treatment, baseline renal function, geographical region, N of antihypertensive medications, baseline HbA1c and baseline daytime SBP|Difference calculated as empa 10mg minus placebo.||
1671137|NCT01370005|3074966|Superiority or Other||Mean Difference (Final Values)|-1.98|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-2.33|-1.62|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo.||
1671138|NCT01370005|3074966|Superiority or Other||Mean Difference (Final Values)|-1.49|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.85|-1.13|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline number of antihypertensive med., baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo.||
1671139|NCT01370005|3074967|Superiority or Other||Mean Difference (Final Values)|-30.2|Standard Error of the Mean|2.61|<|0.0001|2-Sided|95.0|-35.32|-25.08|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG|Difference calculated as empa 25mg minus placebo.||
1671140|NCT01370005|3074967|Superiority or Other||Mean Difference (Final Values)|-23.76|Standard Error of the Mean|2.63|<|0.0001|2-Sided|95.0|-28.91|-18.6|||ANCOVA|Model includes treatment, baseline renal function, geographical region, baseline N of antihyperten. med., baseline HbA1c and baseline FPG|Difference calculated as empa 10mg minus placebo.||
1671141|NCT01370005|3074968|Superiority or Other||Odds Ratio (OR)|6.59|||<|0.0001|2-Sided|95.0|3.7|11.75|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c|||
1671142|NCT01370005|3074968|Superiority or Other||Odds Ratio (OR)|6.26|||<|0.0001|2-Sided|95.0|3.51|11.18|||Regression, Logistic|Logistic regression model includes treatment, baseline renal function, region, baseline number of antihypertensive medications and baseline HbA1c|||
1671143|NCT01370005|3074969|Superiority or Other||Mean Difference (Final Values)|-1.72|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|-2.51|-0.93||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.|
1671144|NCT01370005|3074969|Superiority or Other||Mean Difference (Final Values)|-1.36|Standard Error of the Mean|0.4|<|0.0008|2-Sided|95.0|-2.15|-0.56||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h DBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.|
1671201|NCT01369342|3075049|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).|||
1671234|NCT01368042|3075214|Superiority or Other|||||||0.12|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)|||
1671145|NCT01370005|3074970|Superiority or Other||Mean Difference (Final Values)|-4.16|Standard Error of the Mean|0.68|<|0.0001|2-Sided|95.0|-5.5|-2.83||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.|
1671146|NCT01370005|3074970|Superiority or Other||Mean Difference (Final Values)|-3.44|Standard Error of the Mean|0.69|<|0.0001|2-Sided|95.0|-4.78|-2.09||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model incl. baseline (bl) HbA1c, bl mean 24h SBP as lin. covariates; treatment, bl renal function, region, bl N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.|
1671147|NCT01370005|3074971|Superiority or Other||Mean Difference (Final Values)|-0.65|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.75|-0.55||Hierarchical testing, no adjustment of p-values|ANCOVA|Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects|Difference calculated as empa 25mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.|
1671148|NCT01370005|3074971|Superiority or Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.72|-0.52||Hierarchical testing, no adjustment of p-values.|ANCOVA|Model includes baseline HbA1c as lin. covariate and treatment, baseline renal function, region and baseline N of antihyperten. med. as fixed effects|Difference calculated as empa 10mg minus placebo|Hierarchical testing structure was: 1) Change from baseline to week 12 in HbA1c, empa 25mg vs placebo 2) Change from baseline to week 12 in mean 24h SBP, empa 25mg vs placebo 3) Change from baseline to week 12 in HbA1c, empa 10mg vs placebo 4) Change from baseline in mean 24h SBP, empa 10mg vs placebo 5) Change from baseline in mean 24h DBP, empa 25mg vs placebo 6) Change from baseline in mean 24h DBP empa 10mg vs placebo.|
1671149|NCT01369784|3074986|Superiority or Other|||||||0.117|||||||Fisher Exact||||
1671150|NCT01369784|3074987|Superiority or Other|||||||0.057|||||||Fisher Exact||||
1671151|NCT01369784|3074988|Superiority or Other|||||||0.234|||||||Chi-squared||||
1671152|NCT01369784|3074989|Superiority or Other|||||||0.557|||||||Chi-squared||||
1671153|NCT01369784|3074990|Superiority or Other|||||||0.402|||||||Chi-squared||||
1671154|NCT01369784|3074991|Superiority or Other|||||||0.612|||||||Chi-squared||||
1671155|NCT01369784|3074992|Superiority or Other|||||||0.812|||||||Fisher Exact||||
1671156|NCT01369511|3075027|Superiority or Other|||||||0.007||||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16|
1671157|NCT01369511|3075027|Superiority or Other|||||||0.002||||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16|
1671158|NCT01369511|3075027|Superiority or Other|||||||0.315||||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 16|
1671159|NCT01369511|3075027|Superiority or Other|||||||0.031||||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8|
1671160|NCT01369511|3075027|Superiority or Other|||||||0.066||||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8|
1671161|NCT01369511|3075027|Superiority or Other|||||||0.751||||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 8|
1671162|NCT01369511|3075028|Superiority or Other|||||||0.129||||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12|
1671163|NCT01369511|3075028|Superiority or Other|||||||0.291||||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12|
1671164|NCT01369511|3075028|Superiority or Other|||||||0.527||||||p-values are from type 3 tests.|Mixed Models Analysis|||at Week 12|
1671165|NCT01369485|3075029|Superiority or Other|||||||0.5357|||||||Wilcoxon (Mann-Whitney)||||
1671166|NCT01369485|3075029|Superiority or Other|||||||0.2191|||||||Wilcoxon (Mann-Whitney)||||
1671167|NCT01369485|3075030|Superiority or Other|||||||0.7305|||||||Fisher Exact||||
1671168|NCT01369485|3075030|Superiority or Other|||||||0.9814|||||||Fisher Exact|||"Endpoint defined as percentage of patients that much improved or very much improved following treatment."|
1671169|NCT01369485|3075031|Superiority or Other|||||||0.4151||||||Calculated for only those patients who had prior OAB treatment only.|Wilcoxon (Mann-Whitney)||||
1671170|NCT01369485|3075032|Superiority or Other|||||||0.2032|||||||Fisher Exact||||
1671171|NCT01369485|3075033|Superiority or Other|||||||0.0877|||||||Fisher Exact||||
1671172|NCT01369485|3075033|Superiority or Other|||||||0.4147|||||||Fisher Exact||||
1671173|NCT01369485|3075034|Superiority or Other|||||||0.377|||||||Wilcoxon (Mann-Whitney)||||
1671174|NCT01369485|3075034|Superiority or Other|||||||0.9918|||||||Wilcoxon (Mann-Whitney)||||
1671175|NCT01369485|3075035|Superiority or Other|||||||0.4354|||||||Wilcoxon (Mann-Whitney)||||
1671176|NCT01369485|3075036|Superiority or Other|||||||0.6557|||||||Wilcoxon (Mann-Whitney)||||
1671177|NCT01369485|3075037|Superiority or Other|||||||0.3387|||||||Wilcoxon (Mann-Whitney)||||
1671178|NCT01369485|3075038|Superiority or Other|||||||0.3223|||||||Wilcoxon (Mann-Whitney)||||
1671179|NCT01369485|3075038|Superiority or Other|||||||0.2893|||||||Wilcoxon (Mann-Whitney)||||
1671180|NCT01369485|3075039|Superiority or Other|||||||0.4849|||||||Chi-squared||||
1671235|NCT01368042|3075215|Superiority or Other||Mean Difference (Final Values)|-21.4|Standard Deviation|324.8||0.02|||||||Wilcoxon signed rank test-paired samples||n= 215 (paired samples)||
1671181|NCT01369485|3075039|Superiority or Other|||||||0.3636|||||||Chi-squared|||The sample size calculation was determined using the 2-sided Chi-square test with a significance level of 5% and 80% power based upon the following assumptions: (1) proportion of responders at end of 12 weeks of treatment would be 50% in the active (test) group and 25% in the inactive (control) group; (2) a responder was defined as a subject who experienced decrease of ≥50% in mean urgency urinary incontinence episodes (leaks) between baseline and Week 12 of the study; (3) 20 % dropout rate.|
1671182|NCT01369355|3075040|Superiority or Other (legacy)|||||||0.102||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.|||
1671183|NCT01369355|3075040|Superiority or Other (legacy)|||||||0.14||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and ustekinumab induction dose.|||
1671184|NCT01369355|3075041|Superiority or Other (legacy)|||||||0.004||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.|||
1671185|NCT01369355|3075041|Superiority or Other (legacy)|||||||0.035||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.|||
1671186|NCT01369355|3075042|Superiority or Other (legacy)|||||||0.007||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.|||
1671187|NCT01369355|3075042|Superiority or Other (legacy)|||||||0.189||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by ustekinumab induction dose and the induction study.|||
1671188|NCT01369355|3075043|Superiority or Other (legacy)|||||||0.018||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.|||
1671189|NCT01369355|3075043|Superiority or Other (legacy)|||||||0.033||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.|||
1671190|NCT01369355|3075044|Superiority or Other (legacy)|||||||0.005||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.|||
1671191|NCT01369355|3075044|Superiority or Other (legacy)|||||||0.04||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, ustekinumab induction dose and the induction study.|||
1671192|NCT01369342|3075045|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).|||
1671193|NCT01369342|3075045|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).|||
1671194|NCT01369342|3075046|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).|||
1671195|NCT01369342|3075046|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).|||
1671196|NCT01369342|3075047|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).|||
1671197|NCT01369342|3075047|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).|||
1671198|NCT01369342|3075048|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).|||
1671199|NCT01369342|3075048|Superiority or Other||||||<|0.009||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).|||
1671200|NCT01369342|3075049|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test, stratified by study region (Asia, Eastern Europe, or rest of world) and CDAI score (=< 300 or >300).|||
1671403|NCT01363440|3075645|Superiority or Other||Mean Difference (Net)|45.9||||0.0001|2-Sided|97.5|34.7|57.0|||Cochran-Mantel-Haenszel||||
1671202|NCT01369329|3075050|Superiority or Other|||||||0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.|||
1671203|NCT01369329|3075050|Superiority or Other|||||||0.009||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.|||
1671204|NCT01369329|3075051|Superiority or Other|||||||0.002||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.|||
1671205|NCT01369329|3075051|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.|||
1671206|NCT01369329|3075052|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.|||
1671207|NCT01369329|3075052|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.|||
1671208|NCT01369329|3075053|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.|||
1671209|NCT01369329|3075053|Superiority or Other||||||<|0.003||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.|||
1671210|NCT01369329|3075054|Superiority or Other|||||||0.003||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.|||
1671211|NCT01369329|3075054|Superiority or Other|||||||0.002||||||A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.|Cochran-Mantel-Haenszel chi-square test|2-sided Cochran-Mantel-Haenszel chi-square test stratified by study region, CDAI score, and initial response to TNF antagonist therapy.|||
1671212|NCT01369108|3075089|Superiority or Other|||||||0.449|||||||Chi-squared|||null hypothesis no difference in biting pressure|
1671213|NCT01369108|3075089|Superiority or Other|||||||0.522|||||||ANOVA|||null hypothesis no difference in sensitivity to cold|
1671214|NCT01369108|3075090|Superiority or Other|||||||0.66|||||||ANOVA|||null hypothesis no difference in secondary caries|
1671215|NCT01369108|3075090|Superiority or Other|||||||0.18|||||||ANOVA|||null hypothesis no difference in surface integrity|
1671216|NCT01369108|3075090|Superiority or Other|||||||0.79|||||||ANOVA|||null hypothesis no difference in margin discoloration|
1671217|NCT01369108|3075090|Superiority or Other|||||||0.89|||||||ANOVA|||null hypothesis no difference in margin adaptation|
1671218|NCT01369108|3075090|Superiority or Other|||||||0.8|||||||ANOVA|||null hypothesis no difference in anatomic form|
1671219|NCT01369069|3075091|Superiority||Risk Ratio (RR)|0.82||||0.24|2-Sided|95.0|0.58|1.15|||Chi-squared||||
1671220|NCT01369069|3075092|Superiority||Median Difference (Final Values)|0.06||||0.74|2-Sided|95.0|-0.13|0.25|||Wilcoxon (Mann-Whitney)||||
1671221|NCT01369069|3075093|Superiority||Risk Difference (RD)|0.48||||0.88|2-Sided|95.0|-5.79|6.75|||Chi-squared||The data of the estimation parameter and the confidence intervals were presented as percentages.||
1671222|NCT01369069|3075094|Superiority||Risk Difference (RD)|-1.07||||0.77|2-Sided|95.0|-8.33|6.2|||Chi-squared||The data of the estimation parameter and the confidence intervals were presented as percentages.||
1671223|NCT01369069|3075095|Superiority||Risk Difference (RD)|2.58|||<|0.001|2-Sided|95.0|1.29|3.87|||Fisher Exact||The data of the estimation parameter and the confidence intervals were presented as percentages.||
1671224|NCT01369069|3075096|Superiority||Risk Ratio (RR)|0.97||||0.55|2-Sided|95.0|0.87|1.08||The a priori threshold for statistical significance was 0.05.|Regression, Logistic||Adjusted for baseline NIHSS strata (3-7, 8-14, 15-22) and thrombolysis use (Yes/No; includes both IV and IA therapies). Multiple imputation was used for missing data.|It was hypothesized that intensive blood glucose control would be efficacious and safe in acute ischemic stroke patients compared to standard glucose control.|
1671225|NCT01369030|3075099|Superiority or Other||Mean Difference (Net)|8.5|Standard Deviation|6.3||0|||||||Wilcoxon signed-rank test||||
1671226|NCT01368406|3075196|Superiority or Other||Mean Difference (Final Values)|0.48||||0.055|2-Sided|95.0|0.13|0.83|||t-test, 2 sided||||
1671227|NCT01368406|3075196|Superiority or Other||Mean Difference (Final Values)|-0.48||||0.055|2-Sided|95.0|-0.65|1.13|||t-test, 2 sided|t test for independent samples|||
1671228|NCT01368276|3075197|Superiority or Other||Treatment Difference|-1.2||||1|2-Sided|95.0|-57.3|54.9||Descriptive|Fisher Exact||Talimogene laherparepvec - GM-CSF||
1671229|NCT01368276|3075198|Superiority or Other||Treatment Difference|-42.9||||0.2645|2-Sided|||||Descriptive|Fisher Exact||Talimogene laherparepvec - GM-CSF||
1671230|NCT01368185|3075207|Superiority or Other||% change SBP from Baseline|-9.1|Standard Deviation|0.3|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 SBP minus baseline SBP (n=1245).|Comparison between Month 3 and Baseline|
1671231|NCT01368185|3075208|Superiority or Other||% change DBP from Baseline|-7.1|Standard Deviation|0.4|<|0.01||95.0|||||t-test, 2 sided||Percent change of month 3 DBP minus baseline DBP (n=1239).|Comparison between Month 3 and Baseline|
1671232|NCT01368185|3075209|Superiority or Other||||||<|0.0001|||||||McNemar||||
1671237|NCT01368042|3075217|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Deviation|1.7||0.84|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)||
1671238|NCT01368042|3075218|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Deviation|0.9||0.06|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)||
1671239|NCT01368042|3075219|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Deviation|1.4||0.03|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)||
1671240|NCT01368042|3075220|Superiority or Other||Mean Difference (Final Values)|-9.0|Standard Deviation|41.6||0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)||
1671241|NCT01368042|3075221|Superiority or Other|||||||0.56|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||General health perceptions scale|
1671242|NCT01368042|3075221|Superiority or Other||||||<|0.001|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Bodily pain scale|
1671243|NCT01368042|3075221|Superiority or Other||||||<|0.002|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Social functioning scale|
1671244|NCT01368042|3075221|Superiority or Other||||||<|0.002|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Emotional well-being scale|
1671245|NCT01368042|3075221|Superiority or Other||||||<|0.001|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Energy/fatigue scale|
1671246|NCT01368042|3075221|Superiority or Other||||||<|0.01|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Role functioning due to emotional problems scale|
1671247|NCT01368042|3075221|Superiority or Other||||||<|0.02|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Role functioning due to physical health scale|
1671248|NCT01368042|3075221|Superiority or Other||||||<|0.03|||||||Generalized Estimating Equation approach|Generalized Estimating Equation approach (autoregressive structure)||Physical functioning scale|
1671249|NCT01368042|3075222|Superiority or Other||Mean Difference (Final Values)|14.0|Standard Deviation|32.0|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)||
1671250|NCT01368042|3075223|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Deviation|20.9||0.38|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)||
1671251|NCT01368042|3075224|Superiority or Other||Mean Difference (Final Values)|10.7|Standard Deviation|34.8|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)||
1671252|NCT01368042|3075225|Superiority or Other||Mean Difference (Final Values)|10.3|Standard Deviation|35.3|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)||
1671253|NCT01368042|3075226|Superiority or Other||Mean Difference (Final Values)|8.4|Standard Deviation|27.2|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)||
1671254|NCT01368042|3075227|Superiority or Other||Mean Difference (Final Values)|12.5|Standard Deviation|30.5|<|0.001|||||||Wilcoxon signed rank test-paired samples||n=235 (paired samples)||
1671255|NCT01368042|3075228|Superiority or Other||Mean Difference (Final Values)|10.8|Standard Deviation|56.4||0.003|||||||Wilcoxon signed rank test-paired samples||n=231 (paired samples)||
1671256|NCT01368042|3075229|Superiority or Other||Mean Difference (Final Values)|7.3|Standard Deviation|57.2||0.05|||||||Wilcoxon signed rank test-paired samples||n=231 (paired samples)||
1671257|NCT01368042|3075230|Superiority or Other||Mean Difference (Final Values)|5.7|Standard Deviation|32.9||0.03|||||||Wilcoxon signed rank test-paired samples||n=234 (paired samples)||
1671258|NCT01367886|3075231|Superiority or Other||Mean Difference (Final Values)|1.38|Standard Deviation|1.34||0.0025|||||||t-test, 2 sided||||
1671259|NCT01367886|3075232|Superiority or Other||Mean Difference (Final Values)|0.34|Standard Deviation|1.02||0.18|||||||t-test, 2 sided||||
1671260|NCT01367886|3075233|Superiority or Other||Mean Difference (Final Values)|1.39|Standard Deviation|0.87||0.0021|||||||t-test, 2 sided||||
1671261|NCT01367886|3075234|Superiority or Other||Mean Difference (Final Values)|1.53|Standard Deviation|4.88||0.19|||||||t-test, 2 sided||||
1671262|NCT01367860|3075235|Superiority or Other||Mean Difference (Final Values)|0.7|Standard Error of the Mean|1.17|<|0.05|2-Sided|95.0|-1.67|3.08|||t-test, 2 sided||||
1671263|NCT01367860|3075236|Superiority or Other||Mean Difference (Final Values)|-0.33|Standard Error of the Mean|1.11|<|0.05|2-Sided|95.0|-2.29|2.23|||t-test, 2 sided||||
1671264|NCT01367860|3075237|Superiority or Other||Mean Difference (Final Values)|-0.34|Standard Error of the Mean|1.08|<|0.05|2-Sided|95.0|-2.55|1.85|||t-test, 2 sided||||
1671265|NCT01367860|3075238|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|1.09|<|0.05|2-Sided|95.0|-2.0|2.4|||t-test, 2 sided||||
1671266|NCT01367860|3075239|Superiority or Other||Mean Difference (Final Values)|1.67|Standard Error of the Mean|0.88|<|0.05|2-Sided|95.0|-0.12|3.46|||t-test, 2 sided||||
1671267|NCT01367860|3075240|Superiority or Other||Mean Difference (Final Values)|-1.7|Standard Error of the Mean|3.18|<|0.05|2-Sided|95.0|-8.16|4.76|||t-test, 2 sided||||
1671268|NCT01367860|3075241|Superiority or Other||Mean Difference (Final Values)|0.26|Standard Error of the Mean|3.65|<|0.05|2-Sided|95.0|-7.14|7.67|||t-test, 2 sided||||
1671269|NCT01367860|3075242|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|3.6|<|0.05|2-Sided|95.0|-7.15|7.55|||t-test, 2 sided||||
1671270|NCT01367860|3075243|Superiority or Other||Median Difference (Final Values)|2.2|Standard Error of the Mean|3.3|<|0.05|2-Sided|95.0|-4.4|8.9|||t-test, 2 sided||||
1671271|NCT01367860|3075244|Superiority or Other||Median Difference (Final Values)|3.2|Standard Error of the Mean|2.77|<|0.05|2-Sided|95.0|-2.36|8.8|||t-test, 2 sided||||
1671272|NCT01367860|3075245|Superiority or Other||Mean Difference (Final Values)|1.02|Standard Error of the Mean|1.14|<|0.05|2-Sided|95.0|-1.3|3.3|||t-test, 2 sided||||
1671273|NCT01367860|3075246|Superiority or Other||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|1.13|<|0.05|2-Sided|95.0|-2.58|2.01|||t-test, 2 sided||||
1671274|NCT01367860|3075248|Superiority or Other||Mean Difference (Final Values)|-0.71|Standard Error of the Mean|1.01|<|0.05|2-Sided|95.0|-2.76|1.33|||t-test, 2 sided||||
1671275|NCT01367860|3075249|Superiority or Other||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.9|<|0.05|2-Sided|95.0|-2.21|1.43|||t-test, 2 sided||||
1671276|NCT01367860|3075250|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1671277|NCT01367860|3075251|Superiority or Other||Mean Difference (Final Values)|-1.89|Standard Error of the Mean|1.06||0.05|2-Sided|95.0|-4.05|0.26|||t-test, 2 sided||||
1671278|NCT01367236|3075297|Superiority|||||||0.0009|||||||Regression, Linear||||
1671279|NCT01367236|3075298|Superiority|||||||0.43|||||||Regression, Linear|||48 weeks|
1671280|NCT01367236|3075298|Superiority|||||||0.68|||||||Regression, Linear|||24 weeks|
1671281|NCT01367119|3075318|Superiority or Other|||||||0.86|||||||t-test, 2 sided|||Comparison between groups for recovery room agitation|
1671282|NCT01367119|3075318|Superiority or Other|||||||0.003|||||||t-test, 2 sided|||Comparison between groups for confusion|
1671283|NCT01367119|3075318|Superiority or Other|||||||0.093|||||||t-test, 2 sided|||Comparison between groups for visual disturbance|
1671284|NCT01367119|3075318|Superiority or Other|||||||0.356|||||||t-test, 2 sided|||Comparison between groups for myalgia|
1671285|NCT01367119|3075318|Superiority or Other|||||||0.763|||||||t-test, 2 sided|||Comparison between groups for headache|
1671286|NCT01367119|3075318|Superiority or Other|||||||0.091|||||||t-test, 2 sided|||Comparison between groups for nausea|
1671287|NCT01367119|3075319|Superiority or Other|||||||0.258|||||||t-test, 2 sided|||P-values take into account variability across treatments and within subject.|
1671288|NCT01367119|3075320|Superiority or Other|||||||0.171|||||||t-test, 2 sided|||P-values take into account variability across treatments and within subject.|
1671289|NCT01366976|3075326|Superiority or Other|||||||0.12|||||||Mixed Models Analysis||||
1671290|NCT01366976|3075328|Superiority or Other|||||||0.05|||||||Mixed Models Analysis|||We hypothesized that acetaminophen would reduce peak isofuran concentrations by 22 pg/mL (40% reduction from peak concentrations). If the true difference in the acetaminophen and placebo group means is 22 pg/mL (SD=30 pg/mL), we would need to study 30 experimental subjects and 30 control subjects to be able to reject the null hypothesis that the population means of the acetaminophen and placebo groups are equal with probability (power) 0.8.|
1671291|NCT01366846|3075334|Superiority or Other|||||||0.25|||||||Exact McNemar|||Comparison of the percentage of subjects with peanut allergy in the Peanut Avoidance After Peanut Consumption Group at month 60 to that of the Peanut Avoidance After Peanut Consumption Group at month 72 across both the SPT-negative and SPT-positive strata.|
1671292|NCT01366846|3075335|Superiority or Other|||||||0.25|||||||Exact McNemar|||Comparison of the percentage of subjects with peanut allergy in the Peanut Avoidance After Peanut Consumption Group at month 60 to that of the Peanut Avoidance After Peanut Consumption Group at month 72 across both the SPT-negative and SPT-positive strata.|
1671293|NCT01366846|3075336|Superiority or Other||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group across both the SPT-negative and SPT-positive strata.|
1671294|NCT01366846|3075337|Superiority or Other|||||||0.027|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-positive stratum.|
1671295|NCT01366846|3075337|Superiority or Other||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-negative stratum.|
1671296|NCT01366846|3075338|Superiority or Other||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of participants with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Consumption Group across both the SPT-negative and SPT-positive strata.|
1671297|NCT01366846|3075339|Superiority or Other|||||||0.004|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-positive stratum.|
1671298|NCT01366846|3075339|Superiority or Other||||||<|0.001|||||||Chi-squared|||Comparison of the percentage of subjects with peanut allergy in the Continued Peanut Avoidance Group to that of the Peanut Avoidance After Peanut Consumption Group within the SPT-negative stratum.|
1671299|NCT01366534|3075364|Other||Vaccine Efficacy: Maentel-Haenzel Method|52.4||||0.0021|2-Sided|95.0|25.4|69.6|||2-sided Fisher Exact test|||Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.|
1671300|NCT01366534|3075364|Other||Vaccine Efficacy: Maentel-Haenzel Method|44.0||||0.0066|2-Sided|95.0|20.7|60.4|||2-sided Fisher Exact test|||Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at 1 month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.|
1671301|NCT01366534|3075364|Other||Vaccine Efficacy Maentel-Haenzel Method|-17.6||||0.7675|2-Sided|95.0|-107.4|33.3|||2-sided Fisher Exact test||Pre-defined futility criteria for efficacy: point estimate of increase of VE in Ad35.CS.01 Group over GSK257049 Group less than 0%|Comparison of the efficacy (occurrence of P. falciparum parasitemia, assessed by blood slide) of an immunization regimen comprising of one dose of Ad35.CS.01 vaccine followed one month later by 2 doses of GSK257049 vaccine administered at one month intervals, with that of 3 doses of GSK257049 vaccine administered at one month intervals, in healthy malaria-naïve volunteers aged 18-50 years in the sporozoite challenge model.|
1671371|NCT01363908|3075596|Superiority or Other|||||||0.0417||||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to <18 year olds at 24 weeks|
1671302|NCT01366443|3075386|Superiority or Other||Negative Predictive Value|0.99|||||2-Sided|95.0|0.94|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.|
1671303|NCT01366443|3075386|Superiority or Other||Positive Predictive Value|0.95|||||2-Sided|95.0|0.9|0.98|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.|
1671304|NCT01366443|3075386|Superiority or Other||Specificity|0.91|||||2-Sided|95.0|0.83|0.95|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.|
1671305|NCT01366443|3075386|Superiority or Other||Sensitivity|0.99|||||2-Sided|95.0|0.97|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.|
1671306|NCT01366443|3075386|Superiority or Other||Negative Predictive Value|0.77|||||2-Sided|95.0|0.69|0.84|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.|
1671307|NCT01366443|3075386|Superiority or Other||Positive Predictive Value|0.99|||||2-Sided|95.0|0.96|1.0|||||"The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the Wilson option."|Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.|
1671308|NCT01366443|3075386|Superiority or Other||Specificity|0.98|||||2-Sided|95.0|0.93|0.99|||||The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the “Wilson” option.|Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.|
1671309|NCT01366443|3075386|Superiority or Other||Sensitivity|0.85|||||2-Sided|95.0|0.79|0.89|||||The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the “Wilson” option.|Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.|
1671310|NCT01366417|3075387|Superiority or Other||Mean Difference (Net)|2.6|Standard Deviation|0.133|<|0.05|2-Sided|95.0|2.33|2.86|||ANOVA|||Hypothesis: 70% Isopropyl Alcohol will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment|
1671311|NCT01366417|3075387|Superiority or Other||Mean Difference (Net)|2.65|Standard Deviation|0.133|<|0.05|2-Sided|95.0|2.39|2.91|||ANOVA|||Hypothesis: ChloraPrep One Step will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment.|
1671312|NCT01366417|3075388|Superiority or Other||Mean Difference (Net)|2.25|Standard Deviation|0.133|<|0.05|2-Sided|95.0|1.99|2.51|||ANOVA|||hypothesis: 70% Isopropyl Alcohol will meet or exceed 1.0 log 10 colony forming units / cm^2 at 30 seconds after treatment|
1671313|NCT01366417|3075388|Superiority or Other||Mean Difference (Net)|2.21|Standard Error of the Mean|0.133|<|0.05|2-Sided|95.0|1.95|2.48|||ANOVA|||Hypothesis: ChloraPrep will meet or exceed the 1.0 log reduction in colony forming units/cm^2 at 30 seconds after application.|
1671314|NCT01365845|3075409|Superiority or Other||Non-parametric paired t-test (Wilcoxon)|29.1||||0.0078|||||||Wilcoxon (Mann-Whitney)||||
1671315|NCT01365793|3075419|Superiority|Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).||||||0.43||||||The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.|Cochran-Mantel-Haenszel|||The study uses a factorial experimental design, and tests the two null hypotheses. The second of these hypotheses - the frequency of GCS score declines to <14 is equal between the 0.45% Saline group and the 0.90% Saline group - is reported here. The analysis of the first hypothesis is reported above.|
1671316|NCT01365793|3075419|Superiority|Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).||||||0.34||||||The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.|Cochran-Mantel-Haenszel|||The study uses a factorial experimental design, and tests two null hypotheses. The first of these hypotheses - the frequency of GCS score declines to <14 is equal between the Rapid Rehydration and Slower Rehydration groups - is reported here. The analysis of the second hypothesis is reported below.|
1671317|NCT01365494|3075458|Superiority or Other||Ratio of GMCs-Zagreb and Essen at day 42|0.96||||||95.0|0.86|1.07|||||||
1671318|NCT01365494|3075458|Superiority or Other||Ratio of GMCs-Zagreb and Essen at day 7|0.38|||||2-Sided|95.0|0.3|0.48|||||||
1671319|NCT01365494|3075460|Non-Inferiority or Equivalence|Non-inferiority would be achieved if the lower limit of the two-sided 95% CI of the post vaccination (day 14) ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.667|Ratio of GMCs-Zagreb and Essen at day 14|1.03|||||2-Sided|95.0|0.89|1.19||||||To demonstrate non-inferiority in immune response of the Zagreb postexposure schedule of Rabipur to that of the conventional Essen postexposure schedule at study day 14|
1671320|NCT01365091|3075497|Non-Inferiority or Equivalence|5-OH Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.71%, respectively.|Geometric mean ratio|100.056|||||2-Sided|90.0|97.324|102.864|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671401|NCT01363440|3075644|Superiority or Other||Mean Difference (Net)|34.2|||<|0.0001|2-Sided|97.5|24.1|44.4|||Cochran-Mantel-Haenszel||||
1671321|NCT01365091|3075497|Non-Inferiority or Equivalence|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.72%, respectively.|Geometric mean ratio|101.346|||||2-Sided|90.0|98.574|104.196|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671322|NCT01365091|3075497|Non-Inferiority or Equivalence|Metformin, Arm 4: The corresponding power and the variation coefficient are 94% and 17.13%, respectively.|Geometric mean ratio|93.219|||||2-Sided|90.0|85.835|101.238|||||||
1671323|NCT01365091|3075497|Non-Inferiority or Equivalence|5-OH Sarexagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.08%, respectively.|Geometric mean ratio|100.015|||||2-Sided|95.0|96.56|103.594|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671324|NCT01365091|3075497|Non-Inferiority or Equivalence|Saxagliptin, Arm 5: The corresponding power and the variation coefficient are 99% and 7.07%, respectively.|Geometric mean ratio|97.187|||||2-Sided|90.0|93.832|100.662|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671325|NCT01365091|3075497|Non-Inferiority or Equivalence|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 11.75%, respectively.|Geometric mean ratio|102.383|||||2-Sided|95.0|96.589|108.525|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671326|NCT01365091|3075497|Non-Inferiority or Equivalence|5-OH Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 6.52%, respectively.|Geometric mean ratio|96.258|||||2-Sided|95.0|93.319|99.29|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671327|NCT01365091|3075497|Non-Inferiority or Equivalence|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 5.38%,respectively.|Geometric mean ratio|98.535|||||2-Sided|95.0|96.044|101.09|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671328|NCT01365091|3075497|Non-Inferiority or Equivalence|Metformin, Arm 2: The corresponding power and the variation coefficient are 96% and 14.25%, respectively.|Geometric mean ratio|91.548|||||2-Sided|90.0|85.573|97.939|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671329|NCT01365091|3075497|Non-Inferiority or Equivalence|5-OH Saxagliptin, Arm 1. The corresponding power and the coefficient of variation are 99% and 07.31%, respectively.|Geometric mean ratio|96.76|||||2-Sided|90.0|93.393|100.247|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value).||
1671330|NCT01365091|3075497|Non-Inferiority or Equivalence|Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.60%, respectively.|Geometric mean ratio|97.477|||||2-Sided|90.0|93.955|101.132|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671331|NCT01365091|3075497|Non-Inferiority or Equivalence|For AUC(0-inf) metformin, Arm 1, the corresponding power and coefficient of variation are 80% and 21.06%, respectively.|Geometric mean ratio|91.494|||||2-Sided|90.0|82.697|101.226|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value).||
1671332|NCT01365091|3075499|Non-Inferiority or Equivalence|5-OH Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.73%, respectively.|Geometric mean ratio|100.111|||||2-Sided|90.0|97.367|102.932|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671333|NCT01365091|3075499|Non-Inferiority or Equivalence|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 5.75%, respectively.|Geometric mean ratio|101.281|||||2-Sided|95.0|98.494|104.147|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671334|NCT01365091|3075499|Non-Inferiority or Equivalence|Metformin, Arm 1:The corresponding power and the variation coefficient are 93% and 17.35%, respectively.|Geometric mean ratio|92.953|||||2-Sided|90.0|85.502|101.053|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671335|NCT01365091|3075499|Non-Inferiority or Equivalence|5-OH Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.18%, respectively.|Geometric mean ratio|100.01|||||2-Sided|90.0|96.512|103.648|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671336|NCT01365091|3075499|Non-Inferiority or Equivalence|Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 7.07%, respectively.|Geometric mean ratio|97.135|||||2-Sided|95.0|93.778|100.613|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671337|NCT01365091|3075499|Non-Inferiority or Equivalence|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 12.19%, respectively.|Geometric mean ratio|102.994|||||2-Sided|90.0|96.956|109.407|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671338|NCT01365091|3075499|Non-Inferiority or Equivalence|5-OH Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 6.55%, respectively|Geometric mean ratio|96.239|||||2-Sided|90.0|93.286|99.286|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671339|NCT01365091|3075499|Non-Inferiority or Equivalence|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 96.028% and 101.095%, respectively.|Geometric mean ratio|98.529|||||2-Sided|90.0|96.028|101.095|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671340|NCT01365091|3075499|Non-Inferiority or Equivalence|Metformin, Arm 2: The corresponding power and the variation coefficient are 96% and 14.37%, respectively.|Geometric mean ratio|91.585|||||2-Sided|90.0|85.56|98.035|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671341|NCT01365091|3075499|Non-Inferiority or Equivalence|5-OH Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.43%, respectively.|Geometric mean ratio|96.77|||||2-Sided|90.0|93.35|100.316|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671342|NCT01365091|3075499|Non-Inferiority or Equivalence|Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 07.66%, respectively.|Geometric mean ratio|97.437|||||2-Sided|90.0|93.889|101.119|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671343|NCT01365091|3075499|Non-Inferiority or Equivalence|Metformin, Arm 1: The corresponding power and coefficient of variation are 98% and 17.24%, respectively.|Geometric mean ratio|91.508|||||2-Sided|90.0|82.596|101.38|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671344|NCT01365091|3075500|Non-Inferiority or Equivalence|Saxagliptin, Arm 4: The corresponding power and the variation coefficient are 99% and 10.38%, respectively.|Geometric mean ratio|93.644|||||2-Sided|95.0|89.055|98.47|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671345|NCT01365091|3075500|Non-Inferiority or Equivalence|Metformin, Arm 4: The corresponding power and the variation coefficient are 99% and 10.30%, respectively.|Geometric mean ratio|100.028|||||2-Sided|90.0|95.164|105.139|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671346|NCT01365091|3075500|Non-Inferiority or Equivalence|OH-Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 99% and 12.61%, respectively.|Geometric mean ratio|106.264|||||2-Sided|90.0|99.826|113.117|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671347|NCT01365091|3075500|Non-Inferiority or Equivalence|Saxagliptin, Arm 3: The corresponding power and the variation coefficient are 84% and 15.65%, respectively.|Geometric mean ratio|110.656|||||2-Sided|90.0|102.416|119.559|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671348|NCT01365091|3075500|Non-Inferiority or Equivalence|Metformin, Arm 3: The corresponding power and the variation coefficient are 99% and 15.55%, respectively.|Geometric mean ratio|97.601|||||2-Sided|90.0|15.55|99.0|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671349|NCT01365091|3075500|Non-Inferiority or Equivalence|5-OH saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 8.02%, respectively.|Geometric mean ratio|95.023|||||2-Sided|90.0|91.47|98.714|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671350|NCT01365091|3075500|Non-Inferiority or Equivalence|Saxagliptin, Arm 2: The corresponding power and the variation coefficient are 99% and 13.09%, respectively.|Geometric mean ratio|98.168|||||2-Sided|90.0|92.263|104.451|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671351|NCT01365091|3075500|Non-Inferiority or Equivalence|Metformin, Arm 2: The corresponding power and the variation coefficient are 81% and 14.42%,respectively.|Geometric mean ratio|88.188|||||2-Sided|90.0|82.368|94.419|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671352|NCT01365091|3075500|Non-Inferiority or Equivalence|5-OH Saxagliptin, Arm 1: The corresponding power and the coefficient of variation are 99% and 16.26%, respectively.|Geometric mean ratio|104.373|||||2-Sided|90.0|96.504|112.883|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B= FDC (test value)||
1671353|NCT01365091|3075500|Non-Inferiority or Equivalence|Saxagliptin, Arm 1: The corresponding power and coefficient of variation are 80% and 22.62%, respectively.|Geometric mean ratio|107.606|||||2-Sided|90.0|96.552|119.924|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671354|NCT01365091|3075500|Non-Inferiority or Equivalence|Metformin, Arm 1: The corresponding power and coefficient of variation between test and reference drugs are 98% and 17.24%, respectively|Geometric mean ratio|95.204|||||2-Sided|90.0|87.618|103.446|||||Geometric mean ratio is calculated as B/A, where A=individual tablets (reference value) and B=FDC (test value)||
1671355|NCT01364870|3075516|Superiority|||||||0.008||||||P-value was adjusted using Bonferroni's method to account for multiple comparisons.|Kruskal-Wallis|||There were instances of missing data due to patient time restraints and patient refusal.|
1671356|NCT01364870|3075517|Superiority|||||||0.016||||||The p value was adjusted using Bonferroni's method to account for the multiple comparisons.|Kruskal-Wallis|||There were instances of missing data due to patient time restraints and patient refusal.|
1671357|NCT01364740|3075519|Superiority or Other||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data|
1671358|NCT01364740|3075520|Superiority or Other||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data|
1671359|NCT01364740|3075521|Superiority or Other||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data|
1671360|NCT01364740|3075522|Superiority or Other||||||>|0.05|||||||Sign test|||Patient data from one night with the PMP-300E compared to In-Lab PSG data|
1671361|NCT01364649|3075528|Superiority or Other||LS mean difference|2.2|Standard Error of the Mean|0.9||0.013|2-Sided|95.0|0.48|4.02|||Mixed Model Repeated Measurements|The primary analysis was performed by using observed case data only.|||
1671362|NCT01364467|3075551|Superiority|||||||0.65|||||||t-test, 2 sided||||
1671363|NCT01364467|3075551|Superiority|||||||0.98|||||||t-test, 2 sided||||
1671364|NCT01364467|3075552|Other|||||||0.013|||||||t-test, 2 sided||||
1671365|NCT01364259|3075577|Superiority or Other||Odds Ratio (OR)|0.0||||0.175|2-Sided||||||Fisher Exact||Our odds ratio is equal to 0*5/9*2 because we have a zero cell in the two by two table. Hence the OR = 0.||
1671366|NCT01363908|3075595|Superiority or Other|||||||0.0395||||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to <18 year olds at 48 weeks|
1671367|NCT01363908|3075595|Superiority or Other|||||||0.0044||||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to <18 year olds at 24 weeks|
1671368|NCT01363908|3075595|Superiority or Other|||||||0.3039||||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to <12 year olds at 48 weeks|
1671369|NCT01363908|3075595|Superiority or Other|||||||0.9901||||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to <12 year olds at 24 weeks|
1671370|NCT01363908|3075596|Superiority or Other|||||||0.0409||||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 12 to <18 year olds at 48 weeks|
1671402|NCT01363440|3075645|Superiority or Other||Mean Difference (Net)|38.8||||0.0001|2-Sided|97.5|27.2|50.3|||Cochran-Mantel-Haenszel||||
1671372|NCT01363908|3075596|Superiority or Other|||||||0.441||||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.||Analysis of 6 to <12 year olds at 48 weeks|
1671373|NCT01363908|3075596|Superiority or Other|||||||0.0475||||||The P-value was from paired t test for log-transformed data at post-treatment time point vs. baseline.|paired t test|||Analysis of 6 to <12 year olds at 24 weeks|
1671374|NCT01363908|3075598|Superiority or Other|||||||0.5566||||||P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank|||Analysis of 12 to <18 year olds at 48 weeks|
1671375|NCT01363908|3075598|Superiority or Other|||||||0.8181||||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 12 to <18 year olds at 24 weeks|
1671376|NCT01363908|3075598|Superiority or Other|||||||1||||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 6 to <12 year olds at 48 weeks|
1671377|NCT01363908|3075598|Superiority or Other|||||||0.6875||||||The P-value was from analysis of Wilcoxon signed-rank test at post-treatment time point vs. baseline.|Wilcoxon signed-rank test|||Analysis of 6 to <12 year olds at 24 weeks|
1671378|NCT01363908|3075600|Superiority or Other|||||||0.9219||||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 12 to <18 year olds at 48 weeks|
1671379|NCT01363908|3075600|Superiority or Other|||||||0.2609||||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 12 to <18 year olds at 24 weeks|
1671380|NCT01363908|3075600|Superiority or Other|||||||0.5||||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 6 to <12 year olds at 48 weeks|
1671381|NCT01363908|3075600|Superiority or Other|||||||0.0781||||||The P-value was from the analysis of Wilcoxon signed rank test at post-treatment time point vs baseline.|Wilcoxon signed rank test|||Analysis of 6 to <12 year olds at 24 weeks|
1671382|NCT01363765|3075610|Superiority or Other||NRR|0.52||||0.004|2-Sided|95.0|0.21|0.84||cluster-averaged adjusted NRR|Agregated cluster-averaged||||
1671383|NCT01363765|3075611|Superiority or Other||NRR|0.98||||0.923|2-Sided|95.0|0.64|1.32||cluster-averaged adjusted NRR (notification rate ratio, not calculable from number shown, which are a proportion of tests. NRR calculated over a population/year denominator.|Agregated cluster-averaged||||
1671384|NCT01363765|3075612|Superiority or Other||incremental cost-effectiveness ratio|-84.07||||||95.0|||||||||
1671385|NCT01363765|3075613|Superiority or Other||notification rate ratio|1.7|||<|0.001|2-Sided|95.0|1.51|1.92|||Mixed Models Analysis|Mixed multi-level model, time-adjusted||Secondary analysis: Mixed multi-level model|
1671386|NCT01363765|3075613|Superiority or Other||notification rate ratio|1.59|||<|0.01|2-Sided|95.0|1.32|1.87||NR were calculated using an aggregated database consisting of 896 strata for laboratory (n=14), study month (n=8), sex (n=2) and age group (n=4: <15, 15-39, 40-59, and >=60 years). Poisson regression modeling was used to analyze changes in TB TB NR|Clustered Avareged|Adjustment for municipality, age, sex, and baseline proportion of samples with a positive smear was by a population-averaged quasi-likelihood approach|"The numbers reported in the CONSORT flowchart refer to the diagnostic samples. NR were obtained crosslinking lab and notification databases, denominator was population/year."|cluster-averaged NNR=1.59 (CI95% 1.31-1.88) Absolute numbers informed in table do not allow calculation of notification rates; they are based on population size, not in total numbers and percentages|
1671387|NCT01363700|3075617|Non-Inferiority or Equivalence|Non-inferiority in Mean Ocular hyperemia score compared to Olopatadine was assessed on the non-inferiority margin (0.5) with the upper limit of the confidence interval of the difference between the Epinastine (DE-114) and Olopatadine treatment groups.|Mean Difference (Final Values)|-0.3|||||2-Sided|95.0|-0.81|0.22|||||||
1671388|NCT01363700|3075618|Non-Inferiority or Equivalence|Non-inferiority in Mean Ocular itching score compared to Olopatadine was assessed on the non-inferiority margin (0.5) with the upper limit of the confidence interval of the difference between the Epinastine (DE-114) and Olopatadine treatment groups.|Mean Difference (Final Values)|-0.1|||||2-Sided|95.0|-0.21|0.08|||||||
1671389|NCT01363700|3075619|Superiority or Other||Mean Difference (Final Values)|-1.3|||<|0.001|2-Sided|95.0|-1.71|-0.92|||t-test, 2 sided||||
1671390|NCT01363700|3075620|Superiority or Other||Mean Difference (Final Values)|-1.3|||<|0.001|2-Sided|95.0|-1.52|-1.11|||t-test, 2 sided||||
1671391|NCT01363479|3075639|Non-Inferiority or Equivalence|The null hypothesis was rejected (and non inferiority of oral palonosetron 0.50 mg versus I.V. palonosetron 0.25 mg demonstrated), if the lower limit of the 2 sided 99% CI for the difference in proportion of patients with CR (risk difference) was greater (i.e., closer to zero) than 15%.Study had 90% power.|Risk Difference (RD)|3.21|||||2-Sided|99.0|-2.74|9.17|||||The risk difference and the 99% CI calculation were performed using a 2 sided stratum adjusted Cochran Mantel Haenszel (CMH) test including gender and region as strata.||
1671392|NCT01363440|3075640|Superiority or Other||Mean Difference (Net)|1.65||||0.4067|2-Sided|97.5|-2.83|6.13|||ANCOVA||||
1671393|NCT01363440|3075640|Superiority or Other||Mean Difference (Net)|2.86||||0.1702|2-Sided|97.5|-1.82|7.54|||ANCOVA||||
1671394|NCT01363440|3075641|Superiority or Other||Mean Difference (Net)|4.36||||0.0323|2-Sided|97.5|-0.21|8.93|||ANCOVA||||
1671395|NCT01363440|3075641|Superiority or Other||Mean Difference (Net)|5.19||||0.0168||97.5|0.33|10.04|||ANCOVA||||
1671396|NCT01363440|3075642|Superiority or Other||Mean Difference (Net)|-113.5|||<|0.0001|2-Sided|97.5|-144.2|-82.75|||ANCOVA||||
1671397|NCT01363440|3075642|Superiority or Other||Mean Difference (Net)|-110.8|||<|0.0001|2-Sided|97.5|-141.3|-80.22|||ANCOVA||||
1671398|NCT01363440|3075643|Superiority or Other||Mean Difference (Net)|14.9||||0.0017|2-Sided|97.5|4.4|25.4|||Cochran-Mantel-Haenszel||||
1671399|NCT01363440|3075643|Superiority or Other||Mean Difference (Net)|19.7|||<|0.0001|2-Sided|97.5|9.0|30.4|||Cochran-Mantel-Haenszel||||
1671400|NCT01363440|3075644|Superiority or Other||Mean Difference (Net)|23.3|||<|0.0001|2-Sided|97.5|13.5|33.1|||Cochran-Mantel-Haenszel||||
1671404|NCT01363440|3075646|Superiority or Other||Mean Difference (Net)|10.45|||<|0.0001|2-Sided|97.5|7.73|13.17|||ANCOVA||||
1671405|NCT01363440|3075646|Superiority or Other||Mean Difference (Net)|12.19|||<|0.0001|2-Sided|97.5|9.35|15.04|||ANCOVA||||
1671406|NCT01363258|3075674|Other|Generalized linear mixed models fitted with binomial (logit link) and gamma (log link) distributions, with additional dispersion parameters, were used to estimate and test intervention effects in terms of occurrence and intensity of CRBs, respectively. Inference was conducted in the link scale, but inverse-link estimates in the original scales (proportions and CRB scores, for the binomial and gamma models, respectively) were computed to facilitate interpretation.|Effect size|-0.16||||0.1433|2-Sided||||||Time by group interaction test||||
1671407|NCT01362608|3075796|Superiority or Other||Hazard Ratio (HR)|0.26||||0.0043|2-Sided|95.0|0.1|0.71|||Regression, Cox||||
1671408|NCT01362608|3075797|Superiority or Other||Mean Difference (Final Values)|-19.69|||<|0.0001|2-Sided|95.0|-28.2|-11.2|||ANCOVA||||
1671409|NCT01362530|3075798|Superiority or Other||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.|||
1671410|NCT01362530|3075799|Superiority or Other||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.|||
1671411|NCT01362530|3075800|Superiority or Other||||||<|0.05|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.|||
1671412|NCT01362530|3075801|Superiority or Other||||||<|0.01|||||||Cochran-Mantel-Haenszel|Stratified by age group, use of dexamethasone as an anti-emetic, and receipt of very high risk emetogenic chemotherapy.|||
1671413|NCT01362491|3075805|Superiority or Other||Difference in proportion|-0.93||||0.898|2-Sided|95.0|-15.22|13.36||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671414|NCT01362491|3075805|Superiority or Other||Difference in proportion|29.37|||<|0.001|2-Sided|95.0|16.19|42.56||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671415|NCT01362491|3075805|Superiority or Other||Difference in proportion|28.71|||<|0.001|2-Sided|95.0|15.72|41.7||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen Sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671416|NCT01362491|3075805|Superiority or Other||Difference in proportion|0.98|||<|0.764|2-Sided|95.0|-5.45|7.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671417|NCT01362491|3075805|Superiority or Other||Difference in proportion|2.35|||<|0.49|2-Sided|95.0|-3.69|8.39||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671418|NCT01362491|3075805|Superiority or Other||Difference in proportion|3.21|||<|0.389|2-Sided|95.0|-3.12|9.55||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen Sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671419|NCT01362491|3075808|Superiority or Other||Difference in proportion|-0.72||||0.889|2-Sided|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671420|NCT01362491|3075808|Superiority or Other||Difference in proportion|41.19|||<|0.001|2-Sided|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671421|NCT01362491|3075808|Superiority or Other||Difference in proportion|40.26|||<|0.001|2-Sided|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671422|NCT01362491|3075808|Superiority or Other||Difference in proportion|-0.72|||<|0.889|2-Sided|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671537|NCT01362244|3075901|Superiority or Other||Mean Difference (Final Values)|0.06||||0.486|2-Sided|95.0|-0.1|0.22|||repeated measures model||Week 2||
1671538|NCT01362244|3075902|Superiority or Other||Mean Difference (Final Values)|0.16||||0.077|2-Sided|95.0|-0.02|0.34|||repeated measures model||Week 25||
1671423|NCT01362491|3075808|Superiority or Other||Difference in proportion|41.19|||<|0.001|2-Sided|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671424|NCT01362491|3075808|Superiority or Other||Difference in proportion|40.26|||<|0.001|2-Sided|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671425|NCT01362491|3075808|Superiority or Other||Difference in proportion|2.96|||<|0.642|2-Sided|95.0|-9.52|15.44||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671426|NCT01362491|3075808|Superiority or Other||Difference in proportion|59.44|||<|0.001|2-Sided|95.0|45.69|73.19||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671427|NCT01362491|3075808|Superiority or Other||Difference in proportion|62.03|||<|0.001|2-Sided|95.0|48.65|75.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671428|NCT01362491|3075808|Superiority or Other||Difference in proportion|10.91|||<|0.033|2-Sided|95.0|0.98|20.83||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671429|NCT01362491|3075808|Superiority or Other||Difference in proportion|7.8|||<|0.055|2-Sided|95.0|2.14|13.46||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671430|NCT01362491|3075808|Superiority or Other||Difference in proportion|18.58|||<|0.002|2-Sided|95.0|10.43|26.73||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671431|NCT01362491|3075809|Superiority or Other||Difference in proportion|-0.72||||0.889|2-Sided|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671432|NCT01362491|3075809|Superiority or Other||Difference in proportion|41.19|||<|0.001|2-Sided|95.0|24.78|57.59||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671433|NCT01362491|3075809|Superiority or Other||Difference in proportion|40.26|||<|0.001|2-Sided|95.0|23.85|56.68||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671434|NCT01362491|3075809|Superiority or Other||Difference in proportion|-0.72|||<|0.889|2-Sided|95.0|-10.89|9.45||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671435|NCT01362491|3075809|Superiority or Other||Difference in proportion|47.59|||<|0.001|2-Sided|95.0|31.35|63.83||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671436|NCT01362491|3075809|Superiority or Other||Difference in proportion|46.68|||<|0.001|2-Sided|95.0|30.43|62.93||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671437|NCT01362491|3075809|Superiority or Other||Difference in proportion|6.4|||<|0.357|2-Sided|95.0|-7.27|20.07||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671438|NCT01362491|3075809|Superiority or Other||Difference in proportion|52.31|||<|0.001|2-Sided|95.0|38.2|66.41||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671439|NCT01362491|3075809|Superiority or Other||Difference in proportion|58.58|||<|0.001|2-Sided|95.0|44.96|72.21||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671440|NCT01362491|3075809|Superiority or Other||Difference in proportion|7.62|||<|0.064|2-Sided|95.0|-0.38|15.63||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671441|NCT01362491|3075809|Superiority or Other||Difference in proportion|4.5|||<|0.146|2-Sided|95.0|0.13|8.88||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671442|NCT01362491|3075809|Superiority or Other||Difference in proportion|12.02|||<|0.015|2-Sided|95.0|5.27|18.77||p-value was calculated using CMH test which was adjusted for baseline Pain Severity Rating (PSR) and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1671443|NCT01362491|3075810|Superiority or Other||Least Square (LS) mean difference|-0.16||||0.812|2-Sided|95.0|-1.49|1.17||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671444|NCT01362491|3075810|Superiority or Other||Least Square (LS) mean difference|6.27|||<|0.001|2-Sided|95.0|4.65|7.89||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671445|NCT01362491|3075810|Superiority or Other||Least Square (LS) mean difference|0.02|||<|0.964|2-Sided|95.0|-0.78|0.82||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671446|NCT01362491|3075810|Superiority or Other||Least Square (LS) mean difference|3.66|||<|0.001|2-Sided|95.0|2.68|4.63||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671447|NCT01362491|3075810|Superiority or Other||Least Square (LS) mean difference|3.67|||<|0.001|2-Sided|95.0|2.71|4.64||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671448|NCT01362491|3075811|Superiority or Other||Least Square (LS) mean difference|-0.06||||0.888|2-Sided|95.0|-0.95|0.82||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671449|NCT01362491|3075811|Superiority or Other||Least Square (LS) mean difference|4.17|||<|0.001|2-Sided|95.0|3.09|5.24||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference [Ibuprofen (Motrin IB) - Placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671450|NCT01362491|3075811|Superiority or Other||Least Square (LS) mean difference|4.1|||<|0.001|2-Sided|95.0|3.03|5.18||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671451|NCT01362491|3075811|Superiority or Other||Least Square (LS) mean difference|0.02|||<|0.943|2-Sided|95.0|-0.52|0.56||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671452|NCT01362491|3075811|Superiority or Other||Least Square (LS) mean difference|2.49|||<|0.001|2-Sided|95.0|1.83|3.15||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference [Ibuprofen (Motrin IB) - Placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671539|NCT01362244|3075902|Superiority or Other||Mean Difference (Final Values)|0.23||||0.028|2-Sided|95.0|0.03|0.42|||repeated measures model||Week 21||
1671540|NCT01362244|3075902|Superiority or Other||Mean Difference (Final Values)|0.21||||0.056|2-Sided|95.0|-0.01|0.43|||repeated measures model||Week 17||
1671453|NCT01362491|3075811|Superiority or Other||Least Square (LS) mean difference|2.51|||<|0.001|2-Sided|95.0|1.85|3.17||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen Sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671454|NCT01362491|3075812|Superiority or Other||Least Square (LS) mean difference|-0.1||||0.684|2-Sided|95.0|-0.57|0.38||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671455|NCT01362491|3075812|Superiority or Other||Least Square (LS) mean difference|2.1|||<|0.001|2-Sided|95.0|1.53|2.68||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671456|NCT01362491|3075812|Superiority or Other||Least Square (LS) mean difference|2.01|||<|0.001|2-Sided|95.0|1.43|2.58||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671457|NCT01362491|3075812|Superiority or Other||Least Square (LS) mean difference|0.0|||<|0.992|2-Sided|95.0|-0.28|0.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference [Ibuprofen Sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671458|NCT01362491|3075812|Superiority or Other||Least Square (LS) mean difference|1.17|||<|0.001|2-Sided|95.0|0.83|1.5||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671459|NCT01362491|3075812|Superiority or Other||Least Square (LS) mean difference|1.16|||<|0.001|2-Sided|95.0|0.83|1.5||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671460|NCT01362491|3075813|Superiority or Other||Least Square (LS) mean difference|-0.18||||0.547|2-Sided|95.0|-0.77|0.41||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671461|NCT01362491|3075813|Superiority or Other||Least Square (LS) mean difference|2.61|||<|0.001|2-Sided|95.0|1.9|3.33||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671462|NCT01362491|3075813|Superiority or Other||Least Square (LS) mean difference|2.44|||<|0.001|2-Sided|95.0|1.72|3.15||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671463|NCT01362491|3075813|Superiority or Other||Least Square (LS) mean difference|0.0|||<|0.982|2-Sided|95.0|-0.45|0.44||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671464|NCT01362491|3075813|Superiority or Other||Least Square (LS) mean difference|1.88|||<|0.001|2-Sided|95.0|1.34|2.42||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671465|NCT01362491|3075813|Superiority or Other||Least Square (LS) mean difference|1.87|||<|0.001|2-Sided|95.0|1.33|2.41||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671466|NCT01362491|3075813|Superiority or Other||Least Square (LS) mean difference|0.02|||<|0.911|2-Sided|95.0|-0.39|0.43||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671467|NCT01362491|3075813|Superiority or Other||Least Square (LS) mean difference|1.78|||<|0.001|2-Sided|95.0|1.28|2.28||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671468|NCT01362491|3075813|Superiority or Other||Least Square (LS) mean difference|1.8|||<|0.001|2-Sided|95.0|1.3|2.3||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1672138|NCT01355523|3076610|Superiority or Other|||||||0.446|||||||Wilcoxon (Mann-Whitney)||||
1671469|NCT01362491|3075814|Superiority or Other||Least Square (LS) mean difference|-0.1||||0.396|2-Sided|95.0|-0.32|0.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671470|NCT01362491|3075814|Superiority or Other||Least Square (LS) mean difference|0.94|||<|0.001|2-Sided|95.0|0.67|1.21||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671471|NCT01362491|3075814|Superiority or Other||Least Square (LS) mean difference|0.84|||<|0.001|2-Sided|95.0|0.57|1.11||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671472|NCT01362491|3075814|Superiority or Other||Least Square (LS) mean difference|-0.03|||<|0.669|2-Sided|95.0|-0.19|0.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671473|NCT01362491|3075814|Superiority or Other||Least Square (LS) mean difference|0.65|||<|0.001|2-Sided|95.0|0.46|0.85||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671474|NCT01362491|3075814|Superiority or Other||Least Square (LS) mean difference|0.62|||<|0.001|2-Sided|95.0|0.42|0.81||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671475|NCT01362491|3075814|Superiority or Other||Least Square (LS) mean difference|0.03|||<|0.651|2-Sided|95.0|-0.11|0.18||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671476|NCT01362491|3075814|Superiority or Other||Least Square (LS) mean difference|0.51|||<|0.001|2-Sided|95.0|0.33|0.69||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671477|NCT01362491|3075814|Superiority or Other||Least Square (LS) mean difference|0.54|||<|0.001|2-Sided|95.0|0.37|0.72||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671478|NCT01362491|3075815|Superiority or Other||Least Square (LS) mean difference|-0.08||||0.663|2-Sided|95.0|-0.46|0.29||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen sodium - (Ibuprofen IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671479|NCT01362491|3075815|Superiority or Other||Least Square (LS) mean difference|1.68|||<|0.001|2-Sided|95.0|1.22|2.13||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671480|NCT01362491|3075815|Superiority or Other||Least Square (LS) mean difference|1.59|||<|0.001|2-Sided|95.0|1.14|2.05||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671481|NCT01362491|3075815|Superiority or Other||Least Square (LS) mean difference|0.03|||<|0.847|2-Sided|95.0|-0.27|0.33||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671482|NCT01362491|3075815|Superiority or Other||Least Square (LS) mean difference|1.22|||<|0.001|2-Sided|95.0|0.85|1.59||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671483|NCT01362491|3075815|Superiority or Other||Least Square (LS) mean difference|1.25|||<|0.001|2-Sided|95.0|0.89|1.62||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671484|NCT01362491|3075815|Superiority or Other||Least Square (LS) mean difference|-0.01|||<|0.943|2-Sided|95.0|-0.29|0.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671588|NCT01362062|3075953|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.|
1671485|NCT01362491|3075815|Superiority or Other||Least Square (LS) mean difference|1.27|||<|0.001|2-Sided|95.0|0.93|1.61||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen (Motrin IB) - placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671486|NCT01362491|3075815|Superiority or Other||Least Square (LS) mean difference|1.26|||<|0.001|2-Sided|95.0|0.92|1.59||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1671487|NCT01362491|3075816|Superiority or Other||Hazard Ratio (HR)|1.21||||0.247|2-Sided|95.0|0.88|1.66||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1671488|NCT01362491|3075816|Superiority or Other||Hazard Ratio (HR)|3.88|||<|0.001|2-Sided|95.0|2.38|6.34||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1671489|NCT01362491|3075816|Superiority or Other||Hazard Ratio (HR)|4.68|||<|0.001|2-Sided|95.0|2.87|7.64||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1671490|NCT01362491|3075817|Superiority or Other||Hazard Ratio (HR)|3.64|||<|0.001|2-Sided|95.0|2.23|5.94||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1671491|NCT01362491|3075817|Superiority or Other||Hazard Ratio (HR)|4.38|||<|0.001|2-Sided|95.0|2.69|7.14||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1671492|NCT01362491|3075818|Superiority or Other||Hazard Ratio (HR)|1.2||||0.253|2-Sided|95.0|0.88|1.65||p-value was calculated using the PH model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error was controlled at 0.05 significance level (2-sided) by declaring pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium vs. placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.|
1671493|NCT01362491|3075819|Superiority or Other||Least-Square (LS) mean difference|6.11|||<|0.001|2-Sided|95.0|4.49|7.73||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|ANOVA|||Treatment difference (Ibuprofen sodium-placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error was controlled at 0.05 significance level (2-sided) by declaring pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium versus (vs.) placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.|
1671494|NCT01362322|3075857|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-pertactin (anti-PRN) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted ratio|0.98|||||2-Sided|95.0|0.85|1.13||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertactin vaccine antigens, one month after booster vaccination.|
1671495|NCT01362322|3075857|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-filamentous haemagglutinin (anti-FHA) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.92|||||2-Sided|95.0|0.83|1.03||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to filamentous haemagglutinin vaccine antigens, one month after booster vaccination.|
1671496|NCT01362322|3075857|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-pertussis toxoid (anti-PT) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.92|||||2-Sided|95.0|0.82|1.04||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to pertussis toxoid vaccine antigens, one month after booster vaccination.|
1671497|NCT01362322|3075858|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-tetanus (anti-T) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted Ratio|0.97|||||2-Sided|95.0|0.86|1.1||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to tetanus vaccine antigens, one month after booster vaccination.|
1671541|NCT01362244|3075902|Superiority or Other||Mean Difference (Final Values)|0.17||||0.058|2-Sided|95.0|-0.01|0.34|||repeated measures model||Week 13||
1671542|NCT01362244|3075902|Superiority or Other||Mean Difference (Final Values)|0.09||||0.365|2-Sided|95.0|-0.1|0.28|||repeated measures model||Week 9||
1671498|NCT01362322|3075858|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-diphtheria (anti-D) antibodies was ≤ 1.5 (clinical limit for non-inferiority).|Adjusted radio|0.96|||||2-Sided|95.0|0.85|1.09||||||Analysis was performed to demonstrate that Boostrix administered using the new syringe presentation was non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to diphteria vaccine antigens, one month after booster vaccination.|
1671499|NCT01362296|3075878|Superiority or Other||Hazard Ratio (HR)|1.14||||0.5197|2-Sided|95.0|0.75|1.75||P-value from the stratified log-rank was adjusted for gender (male versus female).|Log Rank||HRs were estimated using a Pike estimator. The HR from the stratified log-rank test was adjusted for gender (male versus female).||
1671500|NCT01362244|3075894|Superiority or Other||Mean Difference (Final Values)|5.68|||||2-Sided|95.0|-1.33|12.68|||||||
1671501|NCT01362244|3075895|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.06|0.07|||||||
1671502|NCT01362244|3075896|Superiority or Other||Mixed effects model|-13.2||||0.005|2-Sided|95.0|-22.2|-4.22|||ANCOVA||||
1671503|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|0.44||||0.468|2-Sided|95.0|-0.77|1.66|||repeated measures model||WNS, Week 25||
1671504|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|0.64||||0.324|2-Sided|95.0|-0.64|1.91|||repeated measures model||WNS, Week 21||
1671505|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|0.19||||0.75|2-Sided|95.0|-0.98|1.35|||repeated measures model||WNS, Week 17||
1671506|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|0.62||||0.24|2-Sided|95.0|-0.42|1.65|||repeated measures model||WNS, Week 13||
1671507|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|0.68||||0.143|2-Sided|95.0|-0.24|1.6|||repeated measures model||WNS, Week 9||
1671508|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|1.31||||0.002|2-Sided|95.0|0.5|2.12|||repeated measures model||WNS, Week 5||
1671509|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|0.28||||0.444|2-Sided|95.0|-0.45|1.02|||repeated measures model||WNS, Week 2||
1671510|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|0.71||||0.233|2-Sided|95.0|-0.46|1.88|||repeated measures model||MNS, Week 25||
1671511|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|0.65||||0.308|2-Sided|95.0|-0.61|1.9|||repeated measures model||MNS, Week 21||
1671512|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|0.38||||0.481|2-Sided|95.0|-0.69|1.46|||repeated measures model||MNS, Week 17||
1671513|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|0.73||||0.127|2-Sided|95.0|-0.21|1.67|||repeated measures model||MNS, Week 13||
1671514|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|0.79||||0.066|2-Sided|95.0|-0.05|1.64|||repeated measures model||MNS, Week 9||
1671515|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|1.14||||0.008|2-Sided|95.0|0.3|1.97|||repeated measures model||MNS, Week 5||
1671516|NCT01362244|3075897|Superiority or Other||Mean Difference (Final Values)|0.09||||0.79|2-Sided|95.0|-0.61|0.79|||repeated measures model||MNS, Week 2||
1671517|NCT01362244|3075898|Superiority or Other||Mean Difference (Final Values)|26.65||||0.027|2-Sided|95.0|3.1|50.21|||repeated measures model||Week 25||
1671518|NCT01362244|3075898|Superiority or Other||Mean Difference (Final Values)|29.51||||0.014|2-Sided|95.0|6.06|52.96|||repeated measures model||Week 21||
1671519|NCT01362244|3075898|Superiority or Other||Mean Difference (Final Values)|15.4||||0.114|2-Sided|95.0|-3.8|34.59|||repeated measures model||Week 17||
1671520|NCT01362244|3075898|Superiority or Other||Mean Difference (Final Values)|27.71||||0.009|2-Sided|95.0|7.19|48.23|||repeated measures model||Week 13||
1671521|NCT01362244|3075898|Superiority or Other||Mean Difference (Final Values)|7.2||||0.472|2-Sided|95.0|-12.64|27.03|||repeated measures model||Week 9||
1671522|NCT01362244|3075898|Superiority or Other||Mean Difference (Final Values)|16.89||||0.029|2-Sided|95.0|1.77|32.01|||repeated measures model||Week 5||
1671523|NCT01362244|3075898|Superiority or Other||Mean Difference (Final Values)|21.16||||0.005|2-Sided|95.0|6.49|35.83|||repeated measures model||Week 2||
1671524|NCT01362244|3075900|Superiority or Other||Mean Difference (Final Values)|14.13||||0.484|2-Sided|95.0|-25.76|54.02|||repeated measures model||Week 25||
1671525|NCT01362244|3075900|Superiority or Other||Mean Difference (Final Values)|38.72||||0.042|2-Sided|95.0|1.41|76.02|||repeated measures model||Week 21||
1671526|NCT01362244|3075900|Superiority or Other||Mean Difference (Final Values)|38.16||||0.052|2-Sided|95.0|-0.33|76.66|||repeated measures model||Week 17||
1671527|NCT01362244|3075900|Superiority or Other||Mean Difference (Final Values)|23.24||||0.178|2-Sided|95.0|-10.75|57.22|||repeated measures model||Week 13||
1671528|NCT01362244|3075900|Superiority or Other||Mean Difference (Final Values)|8.91||||0.622|2-Sided|95.0|-26.79|44.6|||repeated measures model||Week 9||
1671529|NCT01362244|3075900|Superiority or Other||Mean Difference (Final Values)|14.55||||0.321|2-Sided|95.0|-14.4|43.5|||repeated measures model||Week 5||
1671530|NCT01362244|3075900|Superiority or Other||Mean Difference (Final Values)|5.11||||0.686|2-Sided|95.0|-19.91|30.12|||repeated measures model||Week 2||
1671531|NCT01362244|3075901|Superiority or Other||Mean Difference (Final Values)|0.18||||0.094|2-Sided|95.0|-0.03|0.4|||repeated measures model||Week 25||
1671532|NCT01362244|3075901|Superiority or Other||Mean Difference (Final Values)|0.28||||0.016|2-Sided|95.0|0.05|0.51|||repeated measures model||Week 21||
1671533|NCT01362244|3075901|Superiority or Other||Mean Difference (Final Values)|0.22||||0.061|2-Sided|95.0|-0.01|0.45|||repeated measures model||Week 17||
1671534|NCT01362244|3075901|Superiority or Other||Mean Difference (Final Values)|0.2||||0.05|2-Sided|95.0|0.0|0.39|||repeated measures model||Week 13||
1671535|NCT01362244|3075901|Superiority or Other||Mean Difference (Final Values)|0.06||||0.546|2-Sided|95.0|-0.14|0.26|||repeated measures model||Week 9||
1671536|NCT01362244|3075901|Superiority or Other||Mean Difference (Final Values)|0.07||||0.384|2-Sided|95.0|-0.08|0.22|||repeated measures model||Week 5||
1671543|NCT01362244|3075902|Superiority or Other||Mean Difference (Final Values)|0.05||||0.495|2-Sided|95.0|-0.1|0.21|||repeated measures model||Week 5||
1671544|NCT01362244|3075902|Superiority or Other||Mean Difference (Final Values)|0.04||||0.567|2-Sided|95.0|-0.1|0.19|||repeated measures model||Week 2||
1671545|NCT01362244|3075919|Superiority or Other||Odds Ratio (OR)|5.4||||0.047|2-Sided|95.0|1.03|28.42|||Regression, Logistic||Week 25||
1671546|NCT01362244|3075919|Superiority or Other||Odds Ratio (OR)|5.85||||0.037|2-Sided|95.0|1.12|30.66|||Regression, Logistic||Week 21||
1671547|NCT01362244|3075919|Superiority or Other||Odds Ratio (OR)|2.74||||0.223|2-Sided|95.0|0.54|13.9|||Regression, Logistic||Week 17||
1671548|NCT01362244|3075919|Superiority or Other||Odds Ratio (OR)|11.65||||0.004|2-Sided|95.0|2.18|62.19|||Regression, Logistic||Week 13||
1671549|NCT01362244|3075919|Superiority or Other||Odds Ratio (OR)|3.9||||0.091|2-Sided|95.0|0.8|18.94|||Regression, Logistic||Week 9||
1671550|NCT01362244|3075919|Superiority or Other||Odds Ratio (OR)|0.95||||0.943|2-Sided|95.0|0.2|4.49|||Regression, Logistic||Week 5||
1671551|NCT01362244|3075919|Superiority or Other||Odds Ratio (OR)|1.4||||0.675|2-Sided|95.0|0.29|6.85|||Regression, Logistic||Week 2||
1671552|NCT01362244|3075919|Superiority or Other||Odds Ratio (OR)|0.74||||0.708|2-Sided|95.0|0.15|3.63|||Regression, Logistic||Week 1||
1671553|NCT01362244|3075920|Superiority or Other|||||||0.016|||||||Fisher Exact|||Statistical data is presented for LOCF|
1671554|NCT01362244|3075920|Superiority or Other|||||||0.003|||||||Fisher Exact|||Statistical data is presented for NR|
1671555|NCT01362205|3075931|Other|||||||0.2454|||||||Wilcoxon (Mann-Whitney)||||
1671556|NCT01362140|3075946|Superiority or Other|||||||0.017|||||||Cochran-Mantel-Haenszel|The overall 2-sided CMH test with IPSS score as stratification factor.||If the primary hypothesis was confirmed, the secondary hypothesis to be tested was that the percentage of participants achieving an IWG erythroid response during the 24-week double-blind treatment period was greater in the darbepoetin alfa group than in the placebo group. This hypothesis was confirmed if erythroid response was higher in the darbepoetin alfa group and the p-value was < 0.05 from a 2-sided Cochran-Mantel-Haenszel test using the IPSS as a stratification factor.|
1671557|NCT01362140|3075947|Superiority or Other|||||||0.008|||||||Chi-squared|||"The primary hypothesis to be tested was that the percentage of participants with at least~1 RBC transfusion from week 5 to the EOTP was lower in the darbepoetin alfa group than in the placebo group. This hypothesis was confirmed if the incidence of RBC transfusion in the darbepoetin alfa group was lower and had a p-value < 0.05 from a 2-sided Chi-square test."|
1671558|NCT01362062|3075951|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.|
1671559|NCT01362062|3075951|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.|
1671560|NCT01362062|3075951|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.|
1671561|NCT01362062|3075951|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.|
1671562|NCT01362062|3075951|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.|
1671563|NCT01362062|3075951|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.|
1671564|NCT01362062|3075951|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB of Visit 7.|
1671565|NCT01362062|3075951|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.|
1671566|NCT01362062|3075951|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.|
1671567|NCT01362062|3075951|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.|
1671568|NCT01362062|3075951|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.|
1671569|NCT01362062|3075952|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.|
1671570|NCT01362062|3075952|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.|
1671571|NCT01362062|3075952|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.|
1671572|NCT01362062|3075952|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.|
1671573|NCT01362062|3075952|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.|
1671574|NCT01362062|3075952|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.|
1671575|NCT01362062|3075952|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.|
1671576|NCT01362062|3075952|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.|
1671577|NCT01362062|3075952|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.|
1671578|NCT01362062|3075952|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.|
1671579|NCT01362062|3075952|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.|
1671580|NCT01362062|3075953|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.|
1671581|NCT01362062|3075953|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.|
1671582|NCT01362062|3075953|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.|
1671583|NCT01362062|3075953|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.|
1671584|NCT01362062|3075953|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.|
1671585|NCT01362062|3075953|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.|
1671586|NCT01362062|3075953|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.|
1671589|NCT01362062|3075953|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.|
1671590|NCT01362062|3075953|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.|
1671591|NCT01362062|3075954|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 13.|
1671592|NCT01362062|3075954|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 12.|
1671593|NCT01362062|3075954|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 11.|
1671594|NCT01362062|3075954|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 10.|
1671595|NCT01362062|3075954|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 9.|
1671596|NCT01362062|3075954|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 8.|
1671597|NCT01362062|3075954|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 7.|
1671598|NCT01362062|3075954|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 6.|
1671599|NCT01362062|3075954|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 5.|
1671600|NCT01362062|3075954|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 4.|
1671601|NCT01362062|3075954|Superiority or Other||||||=|0|||||||Wilcoxon sign rank test|||Statistical analysis for CFB at Visit 3.|
1671602|NCT01362062|3075955|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 13.|
1671603|NCT01362062|3075955|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 12.|
1671604|NCT01362062|3075955|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 11.|
1671605|NCT01362062|3075955|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 10.|
1671606|NCT01362062|3075955|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 9.|
1671607|NCT01362062|3075955|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 8.|
1671608|NCT01362062|3075955|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 7.|
1671609|NCT01362062|3075955|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 6.|
1671610|NCT01362062|3075955|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 5.|
1671611|NCT01362062|3075955|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 4.|
1671612|NCT01362062|3075955|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 3.|
1671613|NCT01362062|3075956|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 13.|
1671614|NCT01362062|3075956|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 12.|
1671615|NCT01362062|3075956|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 11.|
1671616|NCT01362062|3075956|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 10.|
1671617|NCT01362062|3075956|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 9.|
1671618|NCT01362062|3075956|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 8.|
1671619|NCT01362062|3075956|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 7.|
1671620|NCT01362062|3075956|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 6.|
1671621|NCT01362062|3075956|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 5.|
1671622|NCT01362062|3075956|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 4.|
1671623|NCT01362062|3075956|Superiority or Other||||||=|0|||||||Paired t-test|||Statistical analysis for CFB at Visit 3.|
1671624|NCT01361607|3075999|Superiority||Median Difference (Final Values)|-1.84||||0.2735|2-Sided|95.0|-6.19|1.5|||Wilcoxon (Mann-Whitney)||||
1671625|NCT01361568|3076019|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1671626|NCT01361568|3076020|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1671627|NCT01361568|3076021|Superiority or Other|||||||0.001|||||||Chi-squared|Degrees of freedom (df = 1)|||
1671628|NCT01361568|3076022|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.27|<|0.05|2-Sided|95.0|0.11|1.17|||t-test, 2 sided||||
1671629|NCT01361568|3076022|Superiority or Other||Mean Difference (Final Values)|1.0|Standard Error of the Mean|0.41|<|0.05|2-Sided|95.0|0.22|1.82|||t-test, 2 sided||||
1671630|NCT01361568|3076023|Superiority or Other||Least Squares Mean Difference|-3.31|Standard Error of the Mean|1.74||0.059||95.0|||||Mixed Models Analysis||||
1671631|NCT01361568|3076023|Superiority or Other||Least Squares Mean Difference|-6.39|Standard Error of the Mean|2.63|<|0.05||95.0|||||Mixed Models Analysis||||
1671632|NCT01361568|3076024|Superiority or Other||Mean Difference (Final Values)|-260.4|Standard Error of the Mean|141.99||0.068||95.0|||||t-test, 2 sided||||
1671633|NCT01361568|3076024|Superiority or Other||Mean Difference (Final Values)|-230.1|Standard Error of the Mean|92.26|<|0.05||95.0|||||t-test, 2 sided||||
1671634|NCT01361568|3076024|Superiority or Other||Mean Difference (Final Values)|-420.0|Standard Error of the Mean|139.16|<|0.01||95.0|||||t-test, 2 sided||||
1671635|NCT01361568|3076025|Superiority or Other||Mean Difference (Final Values)|-7.96|Standard Error of the Mean|3.64|<|0.05|2-Sided|95.0|-15.14|-0.78|||t-test, 2 sided||||
1671636|NCT01361308|3076030|Superiority or Other|||||||0.1658||||||Week 12 severity|Rank transformed ANCOVA||||
1671637|NCT01361308|3076030|Superiority or Other|||||||0.0017||||||Week 4 severity|Rank transformed ANCOVA||||
1671638|NCT01361308|3076046|Superiority or Other|||||||0.055||||||Clinical meaningfulness at week 12|Logit model||||
1671639|NCT01361308|3076046|Superiority or Other|||||||0.001||||||Clinical meaningfulness at week 4|Logit model||||
1671640|NCT01361308|3076047|Superiority or Other|||||||0.009||||||Week 12 frequency|Rank transformed ANCOVA||||
1671641|NCT01361308|3076047|Superiority or Other||||||<|0.0001||||||Week 4 frequency|Rank transformed ANCOVA||||
1671642|NCT01361217|3076048|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1671643|NCT01361217|3076049|Other||||||<|0.05|||||||t-test, 2 sided||||
1671644|NCT01361217|3076049|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1671645|NCT01360996|3076069|Superiority or Other||||||<|0.04|||||||ANOVA||||
1671646|NCT01360996|3076070|Superiority or Other||||||<|0.001|||||||ANOVA||||
1671647|NCT01360996|3076071|Superiority or Other||||||<|0.0001|||||||McNemar||||
1671648|NCT01360996|3076072|Superiority or Other||||||<|0.001|||||||ANOVA||||
1671649|NCT01360996|3076073|Superiority or Other||||||>|0.05|||||||ANOVA||||
1671650|NCT01360996|3076074|Superiority or Other||||||>|0.05|||||||ANOVA||||
1671651|NCT01360996|3076075|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1671652|NCT01360840|3076094|Superiority or Other||Cox Proportional Hazard|0.81|||||2-Sided|95.0|0.52|1.27|||||||
1671653|NCT01360840|3076094|Superiority or Other||Cox Proportional Hazard|0.91|||||2-Sided|95.0|0.58|1.44|||||||
1671654|NCT01360840|3076095|Superiority or Other||Cox Proportional Hazard|1.01|||||2-Sided|95.0|0.47|2.15|||||||
1671655|NCT01360840|3076095|Superiority or Other||Cox Proportional Hazard|1.1|||||2-Sided|95.0|0.52|2.31|||||||
1671656|NCT01360840|3076096|Superiority or Other||Cox Proportional Hazard|0.81|||||2-Sided|95.0|0.52|1.26|||||||
1671657|NCT01360840|3076096|Superiority or Other||Cox Proportional Hazard|0.89|||||2-Sided|95.0|0.57|1.39|||||||
1671658|NCT01360645|3076102|Superiority or Other||Ratio of Response Rate|1.69||||0.0002|2-Sided|95.0|1.27|2.27|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.|||
1671659|NCT01360645|3076103|Superiority or Other||Ratio of Response Rate|1.61||||0.0003|2-Sided|95.0|1.23|2.1|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.|||
1671660|NCT01360645|3076104|Superiority or Other||Ratio of Remission Rate|1.67||||0.0671|2-Sided|95.0|0.97|2.9|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.|||
1671661|NCT01360645|3076105|Superiority or Other||Ratio of Remission Rate|1.68||||0.0586|2-Sided|95.0|0.98|2.86|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.|||
1671662|NCT01360645|3076106|Superiority or Other||Ratio of Response Rate|1.54||||0.0429|2-Sided|95.0|1.01|2.35|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.|||
1671663|NCT01360645|3076107|Superiority or Other||Ratio of Response Rate|1.63||||0.0176|2-Sided|95.0|1.09|2.44|||Cochran-Mantel-Haenszel|CHM general association test controlling for trial site.|||
1671664|NCT01360645|3076108|Superiority or Other||Mean Difference (Final Values)|-1.09||||0.0376|2-Sided|95.0|-2.13|-0.06|||ANCOVA||||
1671665|NCT01360645|3076109|Superiority or Other||Mean Difference (Final Values)|-1.17||||0.0219|2-Sided|95.0|-2.17|-0.17|||ANCOVA|||ANCOVA_LOCF model with treatment and trial site as main effects, and baseline (end of Phase A [Week 8]) value as a covariate was used.|
1671666|NCT01360645|3076110|Superiority or Other||Mean Difference (Final Values)|-2.29||||0.0002|2-Sided|95.0|-3.47|-1.12|||ANCOVA||||
1671667|NCT01360645|3076111|Superiority or Other||Mean Difference (Final Values)|-2.34||||0.0001|2-Sided|95.0|-3.47|-1.22|||ANCOVA|||ANCOVA_Last observation carry forward (LOCF) model with treatment and trial site as main effects, and baseline (end of Phase A [Week 8]) value as a covariate was used.|
1671668|NCT01360645|3076112|Superiority or Other||Mean Difference (Final Values)|-0.62||||0.0113|2-Sided|95.0|-1.09|-0.14|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Family life-Week 14|
1671669|NCT01360645|3076112|Superiority or Other||Mean Difference (Final Values)|-0.56||||0.0146|2-Sided|95.0|-1.01|-0.11|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Family life-Week 11|
1671670|NCT01360645|3076112|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.0224|2-Sided|95.0|-1.01|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Social life-Week 14|
1671671|NCT01360645|3076112|Superiority or Other||Mean Difference (Final Values)|-0.49||||0.0267|2-Sided|95.0|-0.92|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Social life-Week 11|
1671672|NCT01360645|3076112|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.608|2-Sided|95.0|-0.7|0.41|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Work/School Week 14|
1671673|NCT01360645|3076112|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.5151|2-Sided|95.0|-0.71|0.36|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Item: Work/School Week 11|
1671674|NCT01360645|3076113|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.0129|2-Sided|95.0|-1.07|-0.13|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Family life: Week 14|
1671675|NCT01360645|3076113|Superiority or Other||Mean Difference (Final Values)|-0.63||||0.0058|2-Sided|95.0|-1.07|-0.18|||Cochran-Mantel-Haenszel|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Family life: Week 11|
1671676|NCT01360645|3076113|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.0323|2-Sided|95.0|-0.96|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Social life: Week 14|
1671900|NCT01360632|3076143|Superiority or Other||Mean Difference (Final Values)|-0.48||||0.0214|2-Sided|95.0|-0.89|-0.07|||Mixed Models Analysis|||Social life: Week 14|
1671677|NCT01360645|3076113|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.0195|2-Sided|95.0|-0.92|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Social life: Week 11|
1671678|NCT01360645|3076113|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.4771|2-Sided|95.0|-0.73|0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 14|
1671679|NCT01360645|3076113|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.3079|2-Sided|95.0|-0.81|0.26|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 11|
1671680|NCT01360645|3076114|Superiority or Other||Mean Difference (Final Values)|-1.54||||0.127|2-Sided|95.0|-3.52|0.44|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14|
1671681|NCT01360645|3076114|Superiority or Other||Mean Difference (Final Values)|-1.42||||0.1424|2-Sided|95.0|-3.33|0.48|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13|
1671682|NCT01360645|3076114|Superiority or Other||Mean Difference (Final Values)|-1.26||||0.1715|2-Sided|95.0|-3.08|0.55|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12|
1671683|NCT01360645|3076114|Superiority or Other||Mean Difference (Final Values)|-0.72||||0.4055|2-Sided|95.0|-2.41|0.98|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11|
1671684|NCT01360645|3076114|Superiority or Other||Mean Difference (Final Values)|-1.16||||0.1322|2-Sided|95.0|-2.68|0.35|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10|
1671685|NCT01360645|3076114|Superiority or Other||Mean Difference (Final Values)|-1.71||||0.0069|2-Sided|95.0|-2.95|-0.47|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9|
1671686|NCT01360645|3076115|Superiority or Other||Mean Difference (Final Values)|-1.96||||0.0435|2-Sided|95.0|-3.87|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14|
1671687|NCT01360645|3076115|Superiority or Other||Mean Difference (Final Values)|-1.75||||0.0626|2-Sided|95.0|-3.59|0.09|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13|
1671688|NCT01360645|3076115|Superiority or Other||Mean Difference (Final Values)|-1.47||||0.0951|2-Sided|95.0|-3.21|0.26|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12|
1671689|NCT01360645|3076115|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.1903|2-Sided|95.0|-2.75|0.55|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11|
1671690|NCT01360645|3076115|Superiority or Other||Mean Difference (Final Values)|-1.53||||0.0436|2-Sided|95.0|-3.01|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10|
1671691|NCT01360645|3076115|Superiority or Other||Mean Difference (Final Values)|-1.57||||0.0139|2-Sided|95.0|-2.82|-0.32|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9|
1671692|NCT01360645|3076116|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.0006|2-Sided|95.0|-0.53|-0.15|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14|
1671693|NCT01360645|3076116|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.0003|2-Sided|95.0|-0.54|-0.16|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13|
1671694|NCT01360645|3076116|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.0084|2-Sided|95.0|-0.42|-0.06|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12|
1671695|NCT01360645|3076116|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.0521|2-Sided|95.0|-0.32|0.0|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11|
1671696|NCT01360645|3076116|Superiority or Other||Mean Difference (Final Values)|-0.11||||0.1286|2-Sided|95.0|-0.25|0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10|
1671697|NCT01360645|3076116|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.0109|2-Sided|95.0|-0.27|-0.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9|
1671698|NCT01360645|3076117|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.0004|2-Sided|95.0|-0.52|-0.15|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 14.|
1671699|NCT01360645|3076117|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.0001|2-Sided|95.0|-0.54|-0.18|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13|
1671700|NCT01360645|3076117|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.0038|2-Sided|95.0|-0.42|-0.08|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12|
1671984|NCT01359904|3076211|Superiority or Other|||||||0.67|||||||Kruskal-Wallis|||post intervention hemoglobin A1c levels|
1671701|NCT01360645|3076117|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.0097|2-Sided|95.0|-0.37|-0.05|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11|
1671702|NCT01360645|3076117|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.0459|2-Sided|95.0|-0.28|0.0|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10|
1671703|NCT01360645|3076117|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.0229|2-Sided|95.0|-0.25|-0.02|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9|
1671704|NCT01360645|3076118|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.0003|2-Sided|95.0|-0.65|-0.19|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 14|
1671705|NCT01360645|3076118|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.0002|2-Sided|95.0|-0.64|-0.2|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 13|
1671706|NCT01360645|3076118|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.0003|2-Sided|95.0|-0.61|-0.18|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 12|
1671707|NCT01360645|3076118|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.0422|2-Sided|95.0|-0.4|-0.01|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 11|
1671708|NCT01360645|3076118|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.029|2-Sided|95.0|-0.37|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 10|
1671709|NCT01360645|3076118|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.001|2-Sided|95.0|-0.4|-0.1|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 9|
1671710|NCT01360645|3076119|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.0005|2-Sided|95.0|-0.6|-0.17|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 14|
1671711|NCT01360645|3076119|Superiority or Other||Mean Difference (Final Values)|-0.41||||0.0001|2-Sided|95.0|-0.62|-0.2|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 13|
1671712|NCT01360645|3076119|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.0005|2-Sided|95.0|-0.57|-0.16|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 12|
1671713|NCT01360645|3076119|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.0255|2-Sided|95.0|-0.41|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 11|
1671714|NCT01360645|3076119|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.0115|2-Sided|95.0|-0.38|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis for Week 10|
1671715|NCT01360645|3076119|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.0022|2-Sided|95.0|-0.38|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.||Statistical analysis for Week 9|
1671716|NCT01360645|3076120|Superiority or Other||Mean Difference (Final Values)|-3.28||||0|2-Sided|95.0|-4.84|-3.28|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13|
1671717|NCT01360645|3076120|Superiority or Other||Mean Difference (Final Values)|-2.52||||0.0009|2-Sided|95.0|-4.0|-1.04|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12|
1671718|NCT01360645|3076120|Superiority or Other||Mean Difference (Final Values)|-2.42||||0.0006|2-Sided|95.0|-3.78|-1.05|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11|
1671719|NCT01360645|3076120|Superiority or Other||Mean Difference (Final Values)|-1.52||||0.0149|2-Sided|95.0|-2.74|-0.3|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10|
1671720|NCT01360645|3076120|Superiority or Other||Mean Difference (Final Values)|-1.31||||0.0086|2-Sided|95.0|-2.28|-0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9|
1671721|NCT01360645|3076121|Superiority or Other||Mean Difference (Final Values)|-3.19||||0|2-Sided|95.0|-4.68|-1.7|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 13|
1671722|NCT01360645|3076121|Superiority or Other||Mean Difference (Final Values)|-2.59||||0.0004|2-Sided|95.0|-4.01|-1.18|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 12|
1671723|NCT01360645|3076121|Superiority or Other||Mean Difference (Final Values)|-2.63||||0.0001|2-Sided|95.0|-3.96|-1.3|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 11|
1671724|NCT01360645|3076121|Superiority or Other||Mean Difference (Final Values)|-1.72||||0.0045|2-Sided|95.0|-2.91|-0.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 10|
1671985|NCT01359904|3076212|Superiority or Other|||||||0.027|||||||Chi-squared||||
1671725|NCT01360645|3076121|Superiority or Other||Mean Difference (Final Values)|-1.29||||0.008|2-Sided|95.0|-2.25|-0.34|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||Statistical analysis for Week 9|
1671726|NCT01360645|3076122|Superiority or Other||Mean Difference (Final Values)|-0.46||||0.0349|2-Sided|95.0|-0.88|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|||
1671727|NCT01360645|3076123|Superiority or Other||Mean Difference (Final Values)|-0.45||||0.0372|2-Sided|95.0|-0.86|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|||
1671728|NCT01360645|3076124|Superiority or Other||Mean Difference (Final Values)|-3.21||||0.0002|2-Sided|95.0|-4.87|-1.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|||
1671729|NCT01360645|3076125|Superiority or Other||Mean Difference (Final Values)|-3.12||||0.0001|2-Sided|95.0|-4.7|-1.54|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.|
1671730|NCT01360632|3076126|Superiority or Other||Ratio of response rate|1.46||||0.0016|2-Sided|95.0|1.15|1.86|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671731|NCT01360632|3076126|Superiority or Other||Ratio of response rate|1.21||||0.1396|2-Sided|95.0|0.94|1.55|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671732|NCT01360632|3076126|Superiority or Other||Ratio of response rate|1.59||||0.0004|2-Sided|95.0|1.22|2.07|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671733|NCT01360632|3076126|Superiority or Other||Ratio of response rate|1.4||||0.0175|2-Sided|95.0|1.06|1.84|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671734|NCT01360632|3076126|Superiority or Other||Ratio of response rate|1.37||||0.0231|2-Sided|95.0|1.04|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671735|NCT01360632|3076126|Superiority or Other||Ratio of response rate|1.22||||0.1689|2-Sided|95.0|0.92|1.63|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671736|NCT01360632|3076126|Superiority or Other||Ratio of response rate|1.51||||0.0156|2-Sided|95.0|1.08|2.11|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671737|NCT01360632|3076126|Superiority or Other||Ratio of response rate|1.41||||0.0526|2-Sided|95.0|1.0|1.99|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671738|NCT01360632|3076126|Superiority or Other||Ratio of response rate|1.75||||0.0065|2-Sided|95.0|1.17|2.63|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671739|NCT01360632|3076126|Superiority or Other||Ratio of response rate|1.77||||0.0101|2-Sided|95.0|1.14|2.74|||Ratio of response rate|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671740|NCT01360632|3076126|Superiority or Other||Ratio of response rate|1.31||||0.3792|2-Sided|95.0|0.73|2.37|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671741|NCT01360632|3076126|Superiority or Other||Ratio of response rate|1.22||||0.5836|2-Sided|95.0|0.6|2.49|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671742|NCT01360632|3076127|Superiority or Other||Ratio of response rate|1.33||||0.0122|2-Sided|95.0|1.06|1.66|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671743|NCT01360632|3076127|Superiority or Other||Ratio of response rate|1.12||||0.3249|2-Sided|95.0|0.89|1.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671744|NCT01360632|3076127|Superiority or Other||Ratio of response rate|1.49||||0.0011|2-Sided|95.0|1.17|1.89|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671745|NCT01360632|3076127|Superiority or Other||Ratio of response rate|1.36||||0.0179|2-Sided|95.0|1.05|1.75|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671746|NCT01360632|3076127|Superiority or Other||Ratio of response rate|1.31||||0.0369|2-Sided|95.0|1.01|1.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671747|NCT01360632|3076127|Superiority or Other||Ratio of response rate|1.18||||0.2224|2-Sided|95.0|0.9|1.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671748|NCT01360632|3076127|Superiority or Other||Ratio of response rate|1.41||||0.025|2-Sided|95.0|1.05|1.91|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671749|NCT01360632|3076127|Superiority or Other||Ratio of response rate|1.34||||0.0665|2-Sided|95.0|0.98|1.83|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671750|NCT01360632|3076127|Superiority or Other||Ratio of response rate|1.7||||0.0066|2-Sided|95.0|1.15|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671751|NCT01360632|3076127|Superiority or Other||Ratio of response rate|1.8||||0.0031|2-Sided|95.0|1.21|2.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671752|NCT01360632|3076127|Superiority or Other||Ratio of response rate|1.37||||0.2677|2-Sided|95.0|0.79|2.36|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671753|NCT01360632|3076127|Superiority or Other||Ratio of response rate|1.41||||0.2873|2-Sided|95.0|0.75|2.65|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671754|NCT01360632|3076128|Superiority or Other||Ratio of response rate|1.31||||0.3012|2-Sided|95.0|0.78|2.18|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671755|NCT01360632|3076128|Superiority or Other||Ratio of response rate|1.45||||0.1499|2-Sided|95.0|0.87|2.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671756|NCT01360632|3076128|Superiority or Other||Ratio of response rate|1.6||||0.1009|2-Sided|95.0|0.91|2.82|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671757|NCT01360632|3076128|Superiority or Other||Ratio of response rate|1.26||||0.4498|2-Sided|95.0|0.69|2.28|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671758|NCT01360632|3076128|Superiority or Other||Ratio of response rate|1.48||||0.2387|2-Sided|95.0|0.76|2.89|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671759|NCT01360632|3076128|Superiority or Other||Ratio of response rate|1.62||||0.1368|2-Sided|95.0|0.86|3.07||CMH general association test controlling for trial site|Cochran-Mantel-Haenszel|||Statistical analysis 1 at Week 12 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671760|NCT01360632|3076128|Superiority or Other||Ratio of response rate|1.17||||0.696|2-Sided|95.0|0.54|2.52|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671761|NCT01360632|3076128|Superiority or Other||Ratio of response rate|1.47||||0.3027|2-Sided|95.0|0.7|3.1|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11 All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671762|NCT01360632|3076128|Superiority or Other||Ratio of response rate|0.6||||0.3266|2-Sided|95.0|0.23|1.62|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671763|NCT01360632|3076128|Superiority or Other||Ratio of response rate|0.59||||0.32|2-Sided|95.0|0.21|1.66|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671764|NCT01360632|3076128|Superiority or Other||Ratio of response rate|0.11||||0.0118|2-Sided|95.0|0.01|0.93|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671765|NCT01360632|3076128|Superiority or Other||Ratio of response rate|0.6||||0.3867|2-Sided|95.0|0.18|1.97|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671766|NCT01360632|3076129|Superiority or Other||Ratio of response rate|1.19||||0.464|2-Sided|95.0|0.74|1.92|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671767|NCT01360632|3076129|Superiority or Other||Ratio of response rate|1.3||||0.2843|2-Sided|95.0|0.81|2.07|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671768|NCT01360632|3076129|Superiority or Other||Ratio of response rate|1.44||||0.1743|2-Sided|95.0|0.85|2.41|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671769|NCT01360632|3076129|Superiority or Other||Ratio of response rate|1.18||||0.5538|2-Sided|95.0|0.69|2.02|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671770|NCT01360632|3076129|Superiority or Other||Ratio of response rate|1.48||||0.2409|2-Sided|95.0|0.76|2.87|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671771|NCT01360632|3076129|Superiority or Other||Ratio of response rate|1.82||||0.0554|2-Sided|95.0|0.99|3.35|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671772|NCT01360632|3076129|Superiority or Other||Ratio of response rate|1.13||||0.7513|2-Sided|95.0|0.54|2.37|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671789|NCT01360632|3076130|Superiority or Other||Ratio of response rate|0.87||||0.7993|2-Sided|95.0|0.3|2.55|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671773|NCT01360632|3076129|Superiority or Other||Ratio of response rate|1.5||||0.248|2-Sided|95.0|0.75|2.99|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671774|NCT01360632|3076129|Superiority or Other||Ratio of response rate|0.59||||0.2846|2-Sided|95.0|0.22|1.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671775|NCT01360632|3076129|Superiority or Other||Ratio of response rate|0.93||||0.8609|2-Sided|95.0|0.4|2.17|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671776|NCT01360632|3076129|Superiority or Other||Ratio of response rate|0.13||||0.0141|2-Sided|95.0|0.02|0.94|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671777|NCT01360632|3076129|Superiority or Other||Ratio of remission rate|1.03||||0.9498|2-Sided|95.0|0.37|2.9|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671778|NCT01360632|3076130|Superiority or Other||Ratio of response rate|1.65||||0.0162|2-Sided|95.0|1.09|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671779|NCT01360632|3076130|Superiority or Other||Ratio of response rate|1.69||||0.0094|2-Sided|95.0|1.14|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671780|NCT01360632|3076130|Superiority or Other||Ratio of response rate|1.41||||0.1078|2-Sided|95.0|0.93|2.14|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671781|NCT01360632|3076130|Superiority or Other||Ratio of response rate|1.32||||0.2124|2-Sided|95.0|0.85|2.06|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671782|NCT01360632|3076130|Superiority or Other||Ratio of response rate|1.62||||0.049|2-Sided|95.0|1.0|2.64|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671783|NCT01360632|3076130|Superiority or Other||Ratio of response rate|1.63||||0.0464|2-Sided|95.0|1.0|2.65|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671784|NCT01360632|3076130|Superiority or Other||Ratio of response rate|1.29||||0.3812|2-Sided|95.0|0.73|2.3|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671785|NCT01360632|3076130|Superiority or Other||Ratio of response rate|1.62||||0.0923|2-Sided|95.0|0.92|2.82|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671786|NCT01360632|3076130|Superiority or Other||Ratio of response rate|1.2||||0.6375|2-Sided|95.0|0.58|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671787|NCT01360632|3076130|Superiority or Other||Ratio of response rate|1.5||||0.2825|2-Sided|95.0|0.71|3.16|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671788|NCT01360632|3076130|Superiority or Other||Ratio of response rate|0.11||||0.0118|2-Sided|95.0|0.01|0.93|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671895|NCT01360632|3076143|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.2182|2-Sided|95.0|-0.59|0.14|||Mixed Models Analysis|||Family life: Week 11|
1671790|NCT01360632|3076131|Superiority or Other||Ratio of response rate|1.51||||0.0326|2-Sided|95.0|1.03|2.21|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671791|NCT01360632|3076131|Superiority or Other||Ratio of response rate|1.53||||0.0248|2-Sided|95.0|1.06|2.2|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671792|NCT01360632|3076131|Superiority or Other||Ratio of response rate|1.23||||0.2951|2-Sided|95.0|0.84|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671793|NCT01360632|3076131|Superiority or Other||Ratio of response rate|1.19||||0.4049|2-Sided|95.0|0.79|1.78|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671794|NCT01360632|3076131|Superiority or Other||Ratio of response rate|1.52||||0.0822|2-Sided|95.0|0.95|2.43|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671795|NCT01360632|3076131|Superiority or Other||Ratio of response rate|1.64||||0.0365|2-Sided|95.0|1.03|2.61|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671796|NCT01360632|3076131|Superiority or Other||Ratio of response rate|1.21||||0.4998|2-Sided|95.0|0.7|2.1|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671797|NCT01360632|3076131|Superiority or Other||Ratio of response rate|1.51||||0.1236|2-Sided|95.0|0.9|2.54|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671798|NCT01360632|3076131|Superiority or Other||Ratio of response rate|1.23||||0.5813|2-Sided|95.0|0.6|2.5|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671799|NCT01360632|3076131|Superiority or Other||Ratio of response rate|1.92||||0.0484|2-Sided|95.0|0.99|3.72|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671800|NCT01360632|3076131|Superiority or Other||Ratio of response rate|0.13||||0.0141|2-Sided|95.0|0.02|0.94|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671801|NCT01360632|3076131|Superiority or Other||Ratio of response rate|1.37||||0.5279|2-Sided|95.0|0.51|3.68|||Cochran-Mantel-Haenszel|CMH general association test controlling for trial site||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671802|NCT01360632|3076132|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.0171|2-Sided|95.0|-0.45|-0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671803|NCT01360632|3076132|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.0237|2-Sided|95.0|-0.39|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671896|NCT01360632|3076143|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.0093|2-Sided|95.0|-0.97|-0.14|||Mixed Models Analysis|||Family life: Week 14|
1671986|NCT01359735|3076215|Superiority or Other|||||||0.178||||||Week 12 Post-surgery|t-test, 1 sided||||
1671804|NCT01360632|3076132|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.0046|2-Sided|95.0|-0.47|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671805|NCT01360632|3076132|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.003|2-Sided|95.0|-0.44|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671806|NCT01360632|3076132|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.0111|2-Sided|95.0|-0.42|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671807|NCT01360632|3076132|Superiority or Other||Mean Difference (Final Values)|-0.27||||0.0021|2-Sided|95.0|-0.44|-0.1|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671808|NCT01360632|3076132|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.0235|2-Sided|95.0|-0.36|-0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671809|NCT01360632|3076132|Superiority or Other||Mean Difference (Final Values)|-0.27||||0.0011|2-Sided|95.0|-0.43|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671810|NCT01360632|3076132|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.0018|2-Sided|95.0|-0.4|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671811|NCT01360632|3076132|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.0021|2-Sided|95.0|-0.41|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671812|NCT01360632|3076132|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.1583|2-Sided|95.0|-0.22|0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671813|NCT01360632|3076132|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.0275|2-Sided|95.0|-0.26|-0.01|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671814|NCT01360632|3076133|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.0527|2-Sided|95.0|-0.39|0.0|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671815|NCT01360632|3076133|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.0755|2-Sided|95.0|-0.33|0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671816|NCT01360632|3076133|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.013|2-Sided|95.0|-0.42|-0.05|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671817|NCT01360632|3076133|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.004|2-Sided|95.0|-0.42|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671897|NCT01360632|3076143|Superiority or Other||Mean Difference (Net)|-0.63||||0.0008|2-Sided|95.0|-0.99|-0.26||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11|
1672139|NCT01355523|3076611|Superiority or Other|||||||0.351|||||||Wilcoxon (Mann-Whitney)||||
1671818|NCT01360632|3076133|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.0152|2-Sided|95.0|-0.39|-0.04|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671819|NCT01360632|3076133|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.0035|2-Sided|95.0|-0.41|-0.08|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671820|NCT01360632|3076133|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.0254|2-Sided|95.0|-0.34|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671821|NCT01360632|3076133|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.0009|2-Sided|95.0|-0.42|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671822|NCT01360632|3076133|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.0019|2-Sided|95.0|-0.38|-0.09|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671823|NCT01360632|3076133|Superiority or Other||Mean Difference (Final Values)|-0.27||||0.0009|2-Sided|95.0|-0.42|-0.11|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean score differ test controlling for study center.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671824|NCT01360632|3076133|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.1334|2-Sided|95.0|-0.22|0.03|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from CMH row mean scores statistics controlling for study center.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671825|NCT01360632|3076133|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.0248|2-Sided|95.0|-0.26|-0.02|||Cochran-Mantel-Haenszel|P-value and treatment difference (CI) are derived from Cochran-Mantel-Haenszel (CMH) row mean score differ test controlling for study center.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671826|NCT01360632|3076134|Superiority or Other||Mean Difference (Final Values)|-0.88||||0.0443|2-Sided|95.0|-1.75|-0.02|||ANCOVA|||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671827|NCT01360632|3076134|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.5192|2-Sided|95.0|-1.14|0.57|||ANCOVA|||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671828|NCT01360632|3076135|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.1939|2-Sided|95.0|-1.39|0.28|||ANCOVA|||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671829|NCT01360632|3076135|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.8164|2-Sided|95.0|-0.93|0.73|||ANCOVA|||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The LOCF method was used to impute missing data.|
1671830|NCT01360632|3076136|Superiority or Other||Mean Difference (Final Values)|-1.69||||0.001|2-Sided|95.0|-2.69|-0.68|||ANCOVA|||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671831|NCT01360632|3076136|Superiority or Other||Mean Difference (Final Values)|-0.78||||0.1226|2-Sided|95.0|-1.78|0.21|||ANCOVA|||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3. The LOCF method was used to impute missing data.|
1671832|NCT01360632|3076137|Superiority or Other||Mean Difference (Final Values)|-1.34||||0.0066|2-Sided|95.0|-2.31|-0.37|||ANCOVA|||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.|
1671833|NCT01360632|3076137|Superiority or Other||Mean Difference (Final Values)|-0.67||||0.1732|2-Sided|95.0|-1.63|0.29|||ANCOVA|||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B. The last observation carried forward (LOCF) method was used to impute missing data.|
1671834|NCT01360632|3076138|Superiority or Other||Mean Difference (Final Values)|-2.13||||0.0251|2-Sided|95.0|-3.98|-0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671835|NCT01360632|3076138|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.0448|2-Sided|95.0|-3.75|-0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671836|NCT01360632|3076138|Superiority or Other||Mean Difference (Final Values)|-1.72||||0.056|2-Sided|95.0|-3.47|0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671837|NCT01360632|3076138|Superiority or Other||Mean Difference (Final Values)|-1.63||||0.0686|2-Sided|95.0|-3.39|0.12|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671838|NCT01360632|3076138|Superiority or Other||Mean Difference (Final Values)|-1.87||||0.0287|2-Sided|95.0|-3.54|-0.19|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671839|NCT01360632|3076138|Superiority or Other||Mean Difference (Final Values)|-2.15||||0.0118|2-Sided|95.0|-3.82|-0.48|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671840|NCT01360632|3076138|Superiority or Other||Mean Difference (Final Values)|-0.83||||0.301|2-Sided|95.0|-2.4|0.74|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671841|NCT01360632|3076138|Superiority or Other||Mean Difference (Final Values)|-2.31||||0.004|2-Sided|95.0|-3.88|-0.74|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671842|NCT01360632|3076138|Superiority or Other||Mean Difference (Final Values)|-1.19||||0.0898|2-Sided|95.0|-2.57|0.19|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671843|NCT01360632|3076138|Superiority or Other||Mean Difference (Final Values)|-1.75||||0.0125|2-Sided|95.0|-3.13|-0.38|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671844|NCT01360632|3076138|Superiority or Other||Mean Difference (Final Values)|-0.49||||0.387|2-Sided|95.0|-1.61|0.63|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671845|NCT01360632|3076138|Superiority or Other||Mean Difference (Final Values)|-1.12||||0.0496|2-Sided|95.0|-2.24|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671846|NCT01360632|3076139|Superiority or Other||Mean Difference (Final Values)|-1.52||||0.1001|2-Sided|95.0|-3.33|0.29|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671847|NCT01360632|3076139|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.0812|2-Sided|95.0|-3.4|0.2|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1672140|NCT01355523|3076612|Superiority or Other|||||||0.264|||||||Wilcoxon (Mann-Whitney)||||
1671848|NCT01360632|3076139|Superiority or Other||Mean Difference (Final Values)|-0.96||||0.2709|2-Sided|95.0|-2.68|0.75|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671849|NCT01360632|3076139|Superiority or Other||Mean Difference (Final Values)|0.1366||||0.1366|2-Sided|95.0|-3.02|0.41|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671850|NCT01360632|3076139|Superiority or Other||Mean Difference (Final Values)|-1.34||||0.1031|2-Sided|95.0|-2.96|0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671851|NCT01360632|3076139|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.0211|2-Sided|95.0|-3.52|-0.29|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671852|NCT01360632|3076139|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.5935|2-Sided|95.0|-1.95|1.11|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671853|NCT01360632|3076139|Superiority or Other||Mean Difference (Final Values)|-2.09||||0.0074|2-Sided|95.0|-3.62|-0.56|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671854|NCT01360632|3076139|Superiority or Other||Mean Difference (Final Values)|-0.89||||0.1898|2-Sided|95.0|-2.23|0.44|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671855|NCT01360632|3076139|Superiority or Other||Mean Difference (Final Values)|-1.86||||0.0064|2-Sided|95.0|-3.2|-0.53|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671856|NCT01360632|3076139|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.5081|2-Sided|95.0|-1.47|0.73|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671857|NCT01360632|3076139|Superiority or Other||Mean Difference (Final Values)|-1.28||||0.0228|2-Sided|95.0|-2.37|-0.18|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671858|NCT01360632|3076140|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.0213|2-Sided|95.0|-0.38|-0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671859|NCT01360632|3076140|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.089|2-Sided|95.0|-0.32|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671860|NCT01360632|3076140|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.0621|2-Sided|95.0|-0.32|0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671898|NCT01360632|3076143|Superiority or Other||Mean Difference (Net)|-0.4||||0.054|2-Sided|95.0|-0.8|0.01|||Mixed Models Analysis|||Social life: Week 14|
1671987|NCT01359735|3076215|Superiority or Other|||||||0.0841||||||Week 3 Post-surgery|t-test, 1 sided||||
1671988|NCT01359735|3076216|Superiority or Other|||||||0.5||||||12 Weeks|t-test, 1 sided||||
1671861|NCT01360632|3076140|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.1168|2-Sided|95.0|-0.3|0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671862|NCT01360632|3076140|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.0398|2-Sided|95.0|-0.31|-0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671863|NCT01360632|3076140|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.0539|2-Sided|95.0|-0.3|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671864|NCT01360632|3076140|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.2503|2-Sided|95.0|-0.22|-0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671865|NCT01360632|3076140|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.0071|2-Sided|95.0|-0.32|-0.05|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671866|NCT01360632|3076140|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.0287|2-Sided|95.0|-0.27|-0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671867|NCT01360632|3076140|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.011|2-Sided|95.0|-0.29|-0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671868|NCT01360632|3076140|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.1406|2-Sided|95.0|-0.16|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671869|NCT01360632|3076140|Superiority or Other||Median Difference (Final Values)|-0.08||||0.0817|2-Sided|95.0|-0.17|0.01|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671870|NCT01360632|3076141|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.0852|2-Sided|95.0|-0.32|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671871|NCT01360632|3076141|Superiority or Other||Mean Difference (Final Values)|-0.11||||0.2015|2-Sided|95.0|-0.28|0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671872|NCT01360632|3076141|Superiority or Other||Mean Difference (Final Values)|-0.11||||0.1855|2-Sided|95.0|-0.27|0.05|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671873|NCT01360632|3076141|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.1553|2-Sided|95.0|-0.28|0.04|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671874|NCT01360632|3076141|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.0912|2-Sided|95.0|-0.28|0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671899|NCT01360632|3076143|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.8281|2-Sided|95.0|-0.4|0.32||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11|
1671989|NCT01359735|3076216|Superiority or Other|||||||0.1354||||||3 Weeks|t-test, 1 sided||||
1671875|NCT01360632|3076141|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.0541|2-Sided|95.0|-0.29|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671876|NCT01360632|3076141|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.3053|2-Sided|95.0|-0.2|0.06|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671877|NCT01360632|3076141|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.0034|2-Sided|95.0|-0.33|-0.07|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671878|NCT01360632|3076141|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.0266|2-Sided|95.0|-0.27|-0.02|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671879|NCT01360632|3076141|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.0012|2-Sided|95.0|-0.34|-0.08|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671880|NCT01360632|3076141|Superiority or Other||Mean Difference (Final Values)|-0.06||||-0.06|2-Sided|95.0|-0.15|0.03|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671881|NCT01360632|3076141|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.0436|2-Sided|95.0|-0.18|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671882|NCT01360632|3076142|Superiority or Other||Mean Difference (Final Values)|-0.59||||0.0077|2-Sided|95.0|-1.02|-0.16||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 14|
1671883|NCT01360632|3076142|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.0824|2-Sided|95.0|-0.73|0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11|
1671884|NCT01360632|3076142|Superiority or Other||Mean Difference (Final Values)|-0.51||||0.0186|2-Sided|95.0|-0.94|-0.09|||Mixed Models Analysis|||Family life: Week 14|
1671885|NCT01360632|3076142|Superiority or Other||Mean Difference (Final Values)|-0.62||||0.0016|2-Sided|95.0|-1.01|-0.24||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 11|
1671886|NCT01360632|3076142|Superiority or Other||Mean Difference (Final Values)|-0.49||||0.0282|2-Sided|95.0|-0.93|-0.05||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 14|
1671887|NCT01360632|3076142|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.486|2-Sided|95.0|-0.54|0.25||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11|
1671888|NCT01360632|3076142|Superiority or Other||Mean Difference (Final Values)|-0.47||||0.0352|2-Sided|95.0|-0.9|-0.03|||Mixed Models Analysis|||Social life: Week 14|
1671889|NCT01360632|3076142|Superiority or Other||Mean Difference (Final Values)|-0.43||||0.0331|2-Sided|95.0|-0.82|-0.03||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11|
1671890|NCT01360632|3076142|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.2952|2-Sided|95.0|-0.82|0.25||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 14|
1671891|NCT01360632|3076142|Superiority or Other||Mean Difference (Final Values)|0.29||||0.2561|2-Sided|95.0|-0.21|0.78||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 11|
1671892|NCT01360632|3076142|Superiority or Other||Mean Difference (Final Values)|-0.46||||0.0816|2-Sided|95.0|-0.99|0.06||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||School/work: Week 14|
1671893|NCT01360632|3076142|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.0341|2-Sided|95.0|-1.01|-0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Work/school: Week 11|
1671894|NCT01360632|3076143|Superiority or Other||Mean Difference (Final Values)|-0.48||||0.0256|2-Sided|95.0|-0.9|-0.06||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Family life: Week 14|
1671901|NCT01360632|3076143|Superiority or Other||Mean Difference (Final Values)|-0.41||||0.0263|2-Sided|95.0|-0.76|-0.05||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Social life: Week 11|
1671902|NCT01360632|3076143|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.4774|2-Sided|95.0|-0.66|0.31|||Mixed Models Analysis|||For Item: Work/School: Week 14|
1671903|NCT01360632|3076143|Superiority or Other||Mean Difference (Final Values)|0.37||||0.0966|2-Sided|95.0|-0.07|0.81||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||For Item: Work/School: Week 11|
1671904|NCT01360632|3076143|Superiority or Other||Mean Difference (Final Values)|-0.43||||0.0741|2-Sided|95.0|-0.91|0.04||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis||-0.43|For Item: Work/School: Week 14|
1671905|NCT01360632|3076143|Superiority or Other||Mean Difference (Final Values)|-0.45||||0.0377|2-Sided|95.0|-0.88|-0.03|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||For Item: Work/School: Week 11|
1671906|NCT01360632|3076144|Superiority or Other||Mean Difference (Final Values)|-0.48||||0.0191|2-Sided|95.0|-0.88|-0.08|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671907|NCT01360632|3076144|Superiority or Other||Mean Difference (Final Values)|-0.49||||0.0158|2-Sided|95.0|-0.89|-0.09|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3|
1671908|NCT01360632|3076144|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.2627|2-Sided|95.0|-0.56|0.15||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate|Mixed Models Analysis|||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671909|NCT01360632|3076144|Superiority or Other||Mean Difference (Final Values)|-0.58||||0.0015|2-Sided|95.0|-0.94|-0.22||MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671910|NCT01360632|3076145|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.0474|2-Sided|95.0|-0.73|0.0|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671911|NCT01360632|3076145|Superiority or Other||Mean Difference (Final Values)|-0.49||||0.0091|2-Sided|95.0|-0.87|-0.12|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 14. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671912|NCT01360632|3076145|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.5792|2-Sided|95.0|-0.41|0.23||MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 2 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B|
1671913|NCT01360632|3076145|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.0008|2-Sided|95.0|-0.87|-0.23||MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.|Mixed Models Analysis|||Statistical analysis 1 at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671914|NCT01360632|3076146|Superiority or Other||Mean Difference (Final Values)|-2.12||||0.0015|2-Sided|95.0|-3.42|-0.81|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671915|NCT01360632|3076146|Superiority or Other||Mean Difference (Final Values)|-1.63||||0.0139|2-Sided|95.0|-2.94|-0.33|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 13. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671916|NCT01360632|3076146|Superiority or Other||Mean Difference (Final Values)|-1.63||||0.0092|2-Sided|95.0|-2.86|-0.41|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671917|NCT01360632|3076146|Superiority or Other||Mean Difference (Final Values)|-1.61||||0.0097|2-Sided|95.0|-2.84|-0.39|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 12. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671990|NCT01359735|3076217|Superiority or Other|||||||0.0594|||||||Log Rank||||
1671918|NCT01360632|3076146|Superiority or Other||Mean Difference (Final Values)|-0.91||||0.1233|2-Sided|95.0|-2.06|0.25|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671919|NCT01360632|3076146|Superiority or Other||Mean Difference (Final Values)|-1.36||||0.0206|2-Sided|95.0|-2.51|-0.21|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 11. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671920|NCT01360632|3076146|Superiority or Other||Mean Difference (Final Values)|-0.97||||0.0732|2-Sided|95.0|-2.04|0.09|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671921|NCT01360632|3076146|Superiority or Other||Mean Difference (Final Values)|-1.17||||0.0313|2-Sided|95.0|-2.23|-0.11|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate||Statistical analysis 1 at Week 10. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671922|NCT01360632|3076146|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.3173|2-Sided|95.0|-1.24|0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 2 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671923|NCT01360632|3076146|Superiority or Other||Mean Difference (Final Values)|-0.92||||0.0286|2-Sided|95.0|-1.74|-0.1|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis 1 at Week 9. All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671924|NCT01360632|3076147|Superiority or Other||Mean Difference (Final Values)|-1.71||||0.0085|2-Sided|95.0|-2.98|-0.44|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671925|NCT01360632|3076147|Superiority or Other||Mean Difference (Final Values)|-1.53||||0.0177|2-Sided|95.0|-2.8|-0.27|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 13. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671926|NCT01360632|3076147|Superiority or Other||Mean Difference (Final Values)|-1.29||||0.034|2-Sided|95.0|-2.48|-0.1|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671927|NCT01360632|3076147|Superiority or Other||Mean Difference (Final Values)|-1.56||||0.0099|2-Sided|95.0|-2.75|-0.38|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 12. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671928|NCT01360632|3076147|Superiority or Other||Mean Difference (Final Values)|-0.71||||0.2097|2-Sided|95.0|-1.82|0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671929|NCT01360632|3076147|Superiority or Other||Mean Difference (Final Values)|-1.39||||0.0139|2-Sided|95.0|-2.5|-0.28|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 11. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671930|NCT01360632|3076147|Superiority or Other||Mean Difference (Final Values)|-0.89||||0.0914|2-Sided|95.0|-1.93|0.14|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671931|NCT01360632|3076147|Superiority or Other||Mean Difference (Final Values)|-1.44||||0.0065|2-Sided|95.0|-2.47|-0.4|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate||Statistical analysis at Week 10. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671932|NCT01360632|3076147|Superiority or Other||Mean Difference (Final Values)|-0.33||||0.4137|2-Sided|95.0|-1.14|0.47|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671933|NCT01360632|3076147|Superiority or Other||Mean Difference (Final Values)|-1.06||||0.0096|2-Sided|95.0|-1.86|-0.26|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||Statistical analysis at Week 9. The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|
1671934|NCT01360632|3076148|Superiority or Other||Mean Difference (Final Values)|-1.95||||0.0079|2-Sided|95.0|-3.39|-0.51|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671935|NCT01360632|3076148|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.0737|2-Sided|95.0|-2.73|0.13|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|
1671936|NCT01360632|3076149|Superiority or Other||Mean Difference (Final Values)|-1.52||||0.0327|2-Sided|95.0|-2.92|-0.13|||Mixed Models Analysis|MMRM method was used with trial site, treatment group, visit, treatment group-by-visit and Baseline-by-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a MMRM analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.|
1671937|NCT01360632|3076149|Superiority or Other||Mean Difference (Final Values)|-1.19||||0.0925|2-Sided|95.0|-2.58|0.2|||Mixed Models Analysis|MMRM method was used with trial site; treatment group-visit; Baseline-visit interaction as an unstructured covariate.||The primary analysis was performed on the Efficacy Sample by fitting a Mixed Model Repeated Measures (MMRM) analysis with an unstructured variance covariance structure in which the change from the end of Phase A (Week 8) in MADRS Total Score (at Weeks 9 to 14) was the dependent variable. The model included fixed class effect terms for treatment, trial site, visit week, and an interaction term of treatment by visit week.|
1671938|NCT01360554|3076150|Superiority or Other||Repeated measures mixed-effects model.|-0.3886||||||95.0|-2.413|1.636|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for EQ-5D VAS. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671939|NCT01360554|3076151|Superiority or Other||Repeated measures mixed-effects model.|0.0322||||||95.0|-4.847|4.911|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Any Med for Pain as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671940|NCT01360554|3076151|Superiority or Other||Repeated measures mixed-effects model.|-1.0687||||||95.0|-4.488|2.351|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain Other Parts as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671941|NCT01360554|3076151|Superiority or Other||Repeated measures mixed-effects model.|-1.1475||||||95.0|-3.902|1.607|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain in Arm or Shoulder as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671942|NCT01360554|3076151|Superiority or Other||Repeated measures mixed-effects model.|-1.2163||||||95.0|-3.885|1.452|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Pain in Chest as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671943|NCT01360554|3076151|Superiority or Other||Repeated measures mixed-effects model.|-1.3637||||||95.0|-4.546|1.819|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Alopecia as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671991|NCT01359735|3076218|Superiority or Other|||||||0.5||||||Over weeks 1 through 4 or Week 4?|Fisher Exact||||
1671992|NCT01359735|3076219|Superiority or Other|||||||0.5||||||Week 13|Wilcoxon (Mann-Whitney)||||
1671993|NCT01359735|3076219|Superiority or Other|||||||0.263||||||Week 04|Wilcoxon (Mann-Whitney)||||
1671944|NCT01360554|3076151|Superiority or Other||Repeated measures mixed-effects model.|-0.6378||||||95.0|-3.684|2.408|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Peripheral Neuropathy as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671945|NCT01360554|3076151|Superiority or Other||Repeated measures mixed-effects model.|-1.1762||||||95.0|-3.56|1.208|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Shortness of Breath as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671946|NCT01360554|3076151|Superiority or Other||Repeated measures mixed-effects model.|9.3545||||||95.0|6.211|12.497|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Sore Mouth as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671947|NCT01360554|3076151|Superiority or Other||Repeated measures mixed-effects model|-1.0764||||||95.0|-3.997|1.845|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Haemoptysis as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671948|NCT01360554|3076151|Superiority or Other||Repeated measures mixed-effects model.|-4.2504||||||95.0|-7.178|-1.322|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Coughing as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671949|NCT01360554|3076151|Superiority or Other||Repeated measures mixed-effects model.|2.6381||||||95.0|0.172|5.104|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for Trouble Swallowing as Assessed by the EORTC-QLQ-LC13. Estimated change from baseline was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671950|NCT01360554|3076152|Superiority or Other||Repeated measures mixed-effects model.|0.3096|||||2-Sided|95.0|-2.646|3.265|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Pain. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671951|NCT01360554|3076152|Superiority or Other||Repeated measures mixed-effects model.|-0.4924|||||2-Sided|95.0|-2.485|1.5|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Nausea and Vomiting. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671952|NCT01360554|3076152|Superiority or Other||Repeated measures mixed-effects model.|-4.8711|||||2-Sided|95.0|-7.998|-1.745|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Insomnia. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671953|NCT01360554|3076152|Superiority or Other||Repeated measures mixed-effects model.|-0.1469||||||95.0|-3.056|2.762|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Financial Difficulties. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671954|NCT01360554|3076152|Superiority or Other||Repeated measures mixed-effects model.|-1.6584|||||2-Sided|95.0|-4.442|1.125|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Fatigue. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671955|NCT01360554|3076152|Superiority or Other||Repeated measures mixed-effects model.|-4.5499|||||2-Sided|95.0|-7.719|-1.381|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Dysponea. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671994|NCT01359046|3076259|Superiority|||||||0.68|||||||Wilcoxon (Mann-Whitney)||||
1671995|NCT01359046|3076260|Superiority|||||||0.3|||||||Wilcoxon (Mann-Whitney)||||
1671956|NCT01360554|3076152|Superiority or Other||Repeated measures mixed-effects model|20.2564|||||2-Sided|95.0|16.874|23.639|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Diarrhea. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671957|NCT01360554|3076152|Superiority or Other||Repeated measures mixed-effects model.|-5.923|||||2-Sided|95.0|-8.432|-3.414|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Constipation. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671958|NCT01360554|3076152|Superiority or Other||Repeated measures mixed-effects model.|1.2851|||||2-Sided|95.0|-2.416|4.986|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Appetite loss. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671959|NCT01360554|3076153|Superiority or Other||Repeated measures mixed-effects model.|-1.497||||||95.0|-4.575|1.581|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 social functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671960|NCT01360554|3076153|Superiority or Other||Repeated measures mixed-effects model.|1.2219||||||95.0|-1.975|4.419|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 role functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671961|NCT01360554|3076153|Superiority or Other||Repeated measures mixed-effects model.|1.5289||||||95.0|-0.756|3.814|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 physical functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671962|NCT01360554|3076153|Superiority or Other||Repeated measures mixed-effects model|0.73||||||95.0|-1.575|3.035|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 emotional functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671963|NCT01360554|3076153|Superiority or Other||Repeated measures mixed-effects model.|0.8067||||||95.0|-1.312|2.926|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 cognitive functioning. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671964|NCT01360554|3076153|Superiority or Other||Repeated measures mixed-effects model.|-1.9357||||||95.0|-4.278|0.407|||||This analysis represents the mean difference between the dacomitinib arm (Arm A) and the erlotinib arm (Arm B).|Analysis presented for QLQ-C30 Global QoL. Mean difference was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects). Confidence intervals provided were not adjusted for multiplicity.|
1671965|NCT01360554|3076161|Superiority or Other||Hazard Ratio (HR)|1.078||||0.775|2-Sided|95.0|0.886|1.312||One-sided P-value.|1-sided stratified log-rank test.|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.||
1671966|NCT01360554|3076162|Superiority or Other||Hazard Ratio (HR)|1.026||||0.638|2-Sided|95.0|0.887|1.188||One-sided P-value.|1-sided stratified log-rank test.|Stratified by EGFR status, KRAS status, and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS status, and baseline ECOG as stratification factors.||
1671967|NCT01360554|3076163|Superiority or Other||Hazard Ratio (HR)|1.057||||0.728|2-Sided|95.0|0.881|1.267||One-sided P-value.|1-sided stratified log-rank test|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.||
1671968|NCT01360554|3076164|Superiority or Other||Hazard Ratio (HR)|0.899||||0.069|2-Sided|95.0|0.78|1.035||Stratified by EGFR status, KRAS status, and baseline ECOG.|1-sided stratified log-rank test|One-sided P-value|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS status, and baseline ECOG as stratification factors.||
1671969|NCT01360554|3076165|Superiority or Other||Hazard Ratio (HR)|1.037||||0.643|2-Sided|95.0|0.848|1.268||One-sided P-value|1-sided stratified log-rank test|Stratified by EGFR status and baseline ECOG.|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status and baseline ECOG as stratification factors.||
1671996|NCT01358877|3076295|Superiority||Treatment Difference|0.1|||||2-Sided|95.0|-0.3|0.5|||||95% CI was estimated using Hauck-Anderson correction.||
1672141|NCT01355523|3076613|Superiority or Other|||||||0.002|||||||Chi-squared||||
1671970|NCT01360554|3076166|Superiority or Other||Hazard Ratio (HR)|0.933||||0.195|2-Sided|95.0|0.797|1.093||One-sided P-value.|1-sided stratified log-rank test|Stratified by epidermal growth factor receptor (EGFR) status, Kirsten Rat Sarcoma status (KRAS), baseline Eastern Cooperative Oncology Group (ECOG).|The HR (Dacomitinib arm versus erlotinib arm) and 95% CI were estimated from stratified Cox regression with EGFR status, KRAS, baseline ECOG as stratification factors.||
1671971|NCT01360450|3076169|Other||Mean Difference (Final Values)|0.05|||>|0.05|2-Sided|||||yes the P value was adjusted for multiple comparisons.|ANOVA|2 sided ANOVA|Mean difference between the two treatment arms||
1671972|NCT01360021|3076190|Non-Inferiority or Equivalence|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|0.26|Standard Error of the Mean|0.23||0.258|2-Sided|95.0|-0.19|0.71|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between BAI Symbicort BA MDI 2x160/4.5 μg bid and pMDI Symbicort AC pMDI 2x160/4.5 µg bid.|
1671973|NCT01360021|3076191|Non-Inferiority or Equivalence|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|-6.1|Standard Error of the Mean|2.69||0.025|2-Sided|95.0|-11.41|-0.79|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.|
1671974|NCT01360021|3076192|Non-Inferiority or Equivalence|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|0.13|Standard Error of the Mean|0.11||0.272|2-Sided|95.0|-0.1|0.35|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.||Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.|
1671975|NCT01360021|3076193|Superiority or Other||Mean Difference (Net)|32.25|Standard Error of the Mean|6.21||0.001|2-Sided|95.0|20.01|44.49|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid and Budesonide AC pMDI 2x160 µg bid.|
1671976|NCT01360021|3076193|Non-Inferiority or Equivalence|No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|1.48|Standard Error of the Mean|6.15||0.81|2-Sided|95.0|-10.66|13.61|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.|
1671977|NCT01360021|3076193|Superiority or Other||Mean Difference (Net)|33.52|Standard Error of the Mean|6.8||0.001|2-Sided|95.0|20.11|46.93|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid minus Budesonide AC pMDI 2x160 µg bid|
1671978|NCT01360021|3076193|Non-Inferiority or Equivalence|No adjustment were be made for multiplicity for these supportive variables and nominal p-values were reported.|Mean Difference (Net)|1.49|Standard Error of the Mean|6.75||0.825|2-Sided|95.0|-11.81|14.8|||ANCOVA|ANCOVA model includes treatment and country as a factor and baseline value as covariate.|Secondary efficacy variables were analyzed as continuous data, comparing mean changes from baseline to the average of the double-blind treatment period between treatments. No adjustment were made for multiplicity and nominal p-values were reported.|Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid|
1671979|NCT01360021|3076194|Non-Inferiority or Equivalence|Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.|Estimated Geometric Mean Ratio|1.03|||||2-Sided|95.0|0.99|1.08|||||The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.|The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid, for pre-dose FEV1.|
1671980|NCT01360021|3076195|Non-Inferiority or Equivalence|Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.|Estimated Geometric Mean Ratio|1.01|||||2-Sided|95.0|0.97|1.05|||||The comparisons was used to assess therapeutic equivalence of Symbicort AC pMDI and Symbicort BA MDI. Assay sensitivity was demonstrated before proceeding to assess therapeutic equivalence of the 2 Symbicort products.|The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid for post dose FEV1.|
1671981|NCT01360021|3076195|Superiority or Other||Estimated Geometic Mean Ratio|1.1||||0.001|2-Sided|95.0|1.06|1.14|||ANCOVA|ANCOVA model on the log transformed outcome variable with treatment and country as factor, and log transformed baseline FEV1 (pre-dose) as covariate.|Symbicort AC pMDI 2x160/4.5 µg bid vs Budesonide AC pMDI 2x160 µg bid|The comparison of Symbicort AC pMDI 2x160/4.5 µg bid with budesonide AC pMDI 2x160 µg bid for post dose FEV1|
1671982|NCT01359904|3076209|Superiority or Other|||||||0.32|||||||Chi-squared||||
1671983|NCT01359904|3076210|Superiority or Other|||||||0.2|||||||Kruskal-Wallis||||
1671997|NCT01358877|3076296|Superiority||Treatment Difference|-0.1|||||2-Sided|95.0|-1.0|0.9|||||95% CI was estimated using Hauck-Anderson correction.||
1671998|NCT01358877|3076297|Superiority||Treatment Difference|0.4|||||2-Sided|95.0|0.0|0.8|||||The difference in percentage of participants with a primary cardiac event between the pertuzumab and placebo arms. The 95% confidence interval (CI) was estimated using Hauck-Anderson correction.||
1671999|NCT01358877|3076299|Superiority||Hazard Ratio (HR)|0.82||||0.1007|2-Sided|95.0|0.64|1.04|||Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.|
1672000|NCT01358877|3076301|Superiority||Hazard Ratio (HR)|0.79||||0.043|2-Sided|95.0|0.63|0.99|||Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.|
1672001|NCT01358877|3076303|Superiority||Hazard Ratio (HR)|0.89||||0.4673|2-Sided|95.0|0.66|1.21||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.|
1672002|NCT01358877|3076305|Superiority||Hazard Ratio (HR)|0.81||||0.0327|2-Sided|95.0|0.67|0.98||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.|
1672003|NCT01358877|3076307|Superiority||Hazard Ratio (HR)|0.82||||0.043|2-Sided|95.0|0.68|0.99||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.|
1672004|NCT01358877|3076309|Superiority||Hazard Ratio (HR)|0.81||||0.0446|2-Sided|95.0|0.66|1.0||Statistical significance was controlled at a two-sided alpha level of 0.05.|Log Rank||Hazard ratio was estimated by Cox regression.|Analysis was performed using stratified log-rank test, which included nodal status, protocol version, central hormone receptor status, and adjuvant chemotherapy regimen as stratification factors in the randomization.|
1672005|NCT01358864|3076318|Superiority or Other|||||||0.0001|||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.|
1672006|NCT01358864|3076318|Superiority or Other||||||<|0.0001|||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.|
1672007|NCT01358864|3076318|Superiority or Other||Adjusted percent difference|-0.1|||<||2-Sided|95.0|-10.9|10.7|||||||
1672008|NCT01358864|3076318|Superiority or Other||Adjusted percent difference|4.5|||<||2-Sided|95.0|-5.8|14.9|||||||
1672009|NCT01358864|3076318|Superiority or Other||Adjusted percent difference|50.4|||<|0.0001|2-Sided|95.0|40.1|60.8||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel||||
1672010|NCT01358864|3076318|Superiority or Other||Adjusted percent difference|54.7|||<|0.0001|2-Sided|95.0|44.4|65.0||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel||||
1672011|NCT01358864|3076320|Superiority or Other|||||||0.0001|||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 24 weeks vs historical rate of 20%.|
1672012|NCT01358864|3076320|Superiority or Other||||||<|0.0001|||||||Normal approximation|||Comparison is based on the Null:Faldaprevir 12 weeks vs historical rate of 20%.|
1672013|NCT01358864|3076320|Superiority or Other||Adjusted percent difference|-0.1|||<||2-Sided|95.0|-10.9|10.7|||||||
1672014|NCT01358864|3076320|Superiority or Other||Adjusted percent difference|4.4|||<||2-Sided|95.0|-6.0|14.9|||||||
1672015|NCT01358864|3076320|Superiority or Other||Adjusted percent difference|48.5|||<|0.0001|2-Sided|95.0|38.2|58.9||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel||||
1672016|NCT01358864|3076320|Superiority or Other||Adjusted percent difference|52.8|||<|0.0001|2-Sided|95.0|42.4|63.2||Adjusted for genotype and previous response to treatment|Cochran-Mantel-Haenszel||||
1672017|NCT01358734|3076352|Superiority or Other||Hazard Ratio (HR)|1.367||||0.356|2-Sided|95.0|0.704|2.653|||Log Rank||||
1672018|NCT01358734|3076352|Superiority or Other||Hazard Ratio (HR)|2.659||||0.014|2-Sided|95.0|1.214|5.822|||Log Rank||||
1672019|NCT01358734|3076352|Superiority or Other||Hazard Ratio (HR)|1.789||||0.119|2-Sided|95.0|0.861|3.718|||Log Rank||||
1672020|NCT01358526|3076382|Superiority or Other|||||||0.0018|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test: responder as dependent variable, treatment as explanatory variable, dose at time of randomization as stratifying factor||Proportion of subjects with a response to treatment that is ≥ 50%|
1672021|NCT01358526|3076383|Superiority or Other|||||||0.0006|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test: responder as dependent variable, treatment as explanatory variable, dose at time of randomization as stratifying factor||Proportion of subjects with a response to treatment that is ≥ 30%|
1672022|NCT01358526|3076384|Superiority or Other|||||||0.0002||||||"The proportion of subjects responding much improved and very much improved was summarized by treatment group and compared between groups using an exact test"|Fisher Exact||||
1672023|NCT01358526|3076385|Superiority or Other||Mean Difference (Final Values)|5.3|Standard Error of the Mean|2.26||0.0191|2-Sided|95.0|0.9|9.8|||Mixed Models Analysis|Mixed-model repeated measures analysis|Mean difference (final values) is the treatment comparison estimated using mixed model repeated measures analysis with effect for treatment, time (weeks 4, 8, 12), treatment by time interaction, and prerandomization value. Subject is a random effect.||
1672024|NCT01358526|3076386|Superiority or Other||Mean Difference (Final Values)|0.45|Standard Error of the Mean|0.163||0.0055|2-Sided|95.0|0.13|0.77||A gate-keeping strategy and a Bonferroni-Holm method was used to control the family-wise (primary and secondary efficacy analysis) error rate at the 5% level.|Mixed Models Analysis|Mixed-model repeated measures analysis of pain data using a pattern mixture model framework|||
1672025|NCT01358357|3076387|Superiority or Other||LS mean difference lurasidone vs.Placebo|0.37||||0.772|2-Sided|95.0|-2.14|2.88||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA||||
1672026|NCT01358357|3076388|Superiority or Other||LS mean difference lurasidone vs.Placebo|-0.1||||0.38|2-Sided|95.0|-0.3|0.1||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA||||
1672027|NCT01358357|3076389|Superiority or Other||LS mean difference lurasidone vs.Placebo|-0.2||||0.788|2-Sided|95.0|-1.6|1.2||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA||||
1672028|NCT01358357|3076390|Superiority or Other||LS mean difference lurasidone vs.Placebo|-0.01||||0.42|2-Sided|95.0|-0.5|0.2||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA||||
1672029|NCT01358357|3076391|Superiority or Other||LS mean difference|-0.2||||0.582|2-Sided|95.0|-0.8|0.5||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA||||
1672030|NCT01358357|3076392|Superiority or Other||LS mean difference lurasdione vs.Placebo|-0.5||||0.485|2-Sided|95.0|-1.9|0.9||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA||||
1672031|NCT01358357|3076393|Superiority or Other||LS mean difference|-0.8||||0.128|2-Sided|95.0|-1.8|0.2||Analysis of Covariance (ANCOVA) model contains treatment, and pool country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA||||
1672032|NCT01358357|3076394|Superiority or Other||LS mean difference lurasidone vs.Placebo|-0.07||||0.496|2-Sided|95.0|-0.27|0.13||Analysis of covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA||||
1672033|NCT01358357|3076395|Superiority or Other||LS mean difference lurasidone vs.Placebo|-0.11||||0.162|2-Sided|95.0|-0.26|0.04||Analysis of Covariance (ANCOVA) model contains treatment, and pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA||||
1672034|NCT01358357|3076396|Superiority or Other||LS mean difference lurasidone vs.Placebo|-0.09||||0.406|2-Sided|95.0|-0.29|0.12||analysis of ANCOVA model contains treatment ,pooled country, and mood stabilizer (lithium or divalproex) as fixed factors and baseline as a covariate.|ANCOVA||||
1672035|NCT01358357|3076398|Superiority or Other||Cox Proportional Hazard|0.72||||0.113|2-Sided|95.0|0.48|1.08||A HR of time to recurrence and its corresponding 95% Wald CI were estimated for lurasidone arm vs. placebo arm,using a Cox proportional hazards model. Model included treatment effect including treatment as a fixed effect stratified by pooled country.|Cox Proportional hazard Model||||
1672036|NCT01358357|3076399|Superiority or Other||Cox Proportional Hazard|0.72|||<|0.034|2-Sided|95.0|0.54|0.98||A HR of time to discontinuation and corresponding 95% Wald CI were est. for lurasidone arm vs.the placebo arm, using a Cox proportional hazards model. Model included treatment effect including treatment as a fixed effect,stratified by pooled country.|Cox Proportional Hazards Model||||
1672037|NCT01358357|3076400|Superiority or Other||Hazard Ratio (HR)|0.71|||<|0.078|2-Sided|95.0|0.49|1.04||A hazard ratio of time to recurrence and its corresponding 95% Wald CI were estimated for the lurasidone arm vs.placebo arm, using a Cox proportional hazards model.Cox model included treatment effect as fixed effect, and stratified by pooled country.|Cox Proportional Hazards Model|||It was assumed that the recurrence event rates during the double-blind phase were to be 24% and 39% for subjects treated with lurasidone and placebo, respectively. A total of 120 recurrence events were required to achieve 90% power to detect the 15% difference in subjects who had a recurrence event during the double-blind phase between the treatment groups using a log-rank test with two sided alpha level of 0.05.|
1672038|NCT01358175|3076416|Superiority or Other||Odds Ratio (OR)|3.89|||<|0.0001|2-Sided|95.0|2.28|6.65|||Regression, Logistic||||
1672039|NCT01358175|3076416|Superiority or Other||Odds Ratio (OR)|3.76|||<|0.0001|2-Sided|95.0|2.2|6.42|||Regression, Logistic||||
1672040|NCT01357980|3076419|Superiority or Other (legacy)||Mean Treatment Difference|-0.4||||0.4|2-Sided|95.0|-1.35|0.55|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.|
1672041|NCT01357980|3076419|Superiority or Other (legacy)||Mean Treatment Difference|-1.38|||<|0.01|2-Sided|95.0|-2.02|-0.73|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.|
1672042|NCT01357980|3076419|Superiority or Other (legacy)||Mean Treatment Difference|-0.48|||<|0.3|2-Sided|95.0|-1.47|0.52|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.|
1672043|NCT01357980|3076419|Superiority or Other (legacy)||Mean Treatment Difference|-0.52|||<|0.3|2-Sided|95.0|-1.56|0.52|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.|
1672044|NCT01357980|3076419|Superiority or Other (legacy)||Mean Treatment Difference|-0.18|||<|0.7|2-Sided|95.0|-1.26|0.9|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.|
1672045|NCT01357980|3076419|Superiority or Other (legacy)||Mean Treatment Difference|-1.13|||<|0.01|2-Sided|95.0|-1.91|-0.35|||ANCOVA|||Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.|
1672046|NCT01357980|3076420|Superiority or Other (legacy)||Mean Treatment Difference|2.1|||<|0.01|||||||Satterthwaite-Welch’s t-test|||Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.|
1672075|NCT01357850|3076467|Superiority or Other||Mean Difference (Final Values)|0.0678||||0.0499|2-Sided|95.0|0.0|0.1356|||ANOVA||||
1672142|NCT01355523|3076614|Superiority or Other|||||||0.46|||||||Fisher Exact||||
1672047|NCT01357980|3076420|Superiority or Other (legacy)||Mean Treatment Difference|1.9|||<|0.05|||||||Satterthwaite-Welch’s t-test|||Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.|
1672048|NCT01357980|3076421|Superiority or Other (legacy)||Mean Treatment Difference|1.8|||<|0.01|||||||Satterthwaite-Welch’s t-test|||Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.|
1672049|NCT01357980|3076421|Superiority or Other (legacy)||Mean Treatment Difference|2.3|||<|0.01|||||||Satterthwaite-Welch’s t-test|||Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch’s t-test for independent samples.|
1672050|NCT01357980|3076422|Superiority or Other (legacy)||Mean Treatment Difference|2.3|||<|0.01|||||||Satterthwaite-Welch’s t-test|||Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch’s t-test for independent samples.|
1672051|NCT01357980|3076422|Superiority or Other (legacy)||Mean Treatment Difference|1.7|||<|0.05||95.0|||||Satterthwaite-Welch’s t-test|||Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch’s t-test for independent samples.|
1672052|NCT01357980|3076423|Superiority or Other (legacy)||Mean Treatment Difference|-45.3|||<|0.01|2-Sided|95.0|-76.6|-14.1|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.|
1672053|NCT01357980|3076423|Superiority or Other (legacy)||Mean Treatment Difference|-32.3|||<|0.01|2-Sided|95.0|-53.7|-11.0|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.|
1672054|NCT01357980|3076423|Superiority or Other (legacy)||Mean Treatment Difference|-51.0|||<|0.01|2-Sided|95.0|-89.5|-12.4|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.|
1672055|NCT01357980|3076423|Superiority or Other (legacy)||Mean Treatment Difference|-35.1|||<|0.03|2-Sided|95.0|-65.6|-4.6|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.|
1672056|NCT01357980|3076423|Superiority or Other (legacy)||Mean Treatment Difference|-67.1|||<|0.01|2-Sided|95.0|-112.9|-21.2|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.|
1672057|NCT01357980|3076423|Superiority or Other (legacy)||Mean Treatment Difference|-23.8|||<|0.25|2-Sided|95.0|-66.6|18.9|||ANCOVA|||Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.|
1672058|NCT01357980|3076424|Superiority or Other (legacy)||Mean Treatment Difference|186.3|||<|0.01|2-Sided|95.0|53.2|319.4|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.|
1672059|NCT01357980|3076424|Superiority or Other (legacy)||Mean Treatment Difference|138.5|||<|0.01|2-Sided|95.0|34.7|242.2|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.|
1672060|NCT01357980|3076424|Superiority or Other (legacy)||Mean Treatment Difference|223.7|||<|0.01|2-Sided|95.0|94.3|353.1|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.|
1672061|NCT01357980|3076424|Superiority or Other (legacy)||Mean Treatment Difference|117.0|||<|0.09||95.0|-20.0|254.0|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.|
1672062|NCT01357980|3076424|Superiority or Other (legacy)||Mean Treatment Difference|224.1|||<|0.01|2-Sided|95.0|140.9|307.4|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.|
1672063|NCT01357980|3076424|Superiority or Other (legacy)||Mean Treatment Difference|219.5|||<|0.01|2-Sided|95.0|69.6|369.5|||ANCOVA|||Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.|
1672064|NCT01357980|3076425|Superiority or Other (legacy)||Mean Treatment Difference|-0.61||||0.07|2-Sided|95.0|-1.27|0.05||No multiplicity adjustment applied: each test conducted at a 5% significance level.|ANCOVA|||Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.|
1672065|NCT01357980|3076425|Superiority or Other (legacy)||Mean Treatment Difference|-1.54||||0.11|2-Sided|95.0|-3.47|0.39||No multiplicity adjustment applied: each test conducted at a 5% significance level.|ANCOVA|||Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.|
1672066|NCT01357889|3076433|Non-Inferiority or Equivalence|To establish BE, the 90% CI for the ratio of Process 3:Process 2 geometric least squares means for Cmax must have fallen within the BE limit of 0.8 and 1.25.|Ratio of Geometric LSMs (P3:P2)|0.927|||||2-Sided|90.0|0.813|1.056|||||||
1672067|NCT01357889|3076434|Non-Inferiority or Equivalence|To establish BE, the 90% CI for the ratio of Process 3 (P3) to Process 2 (P2) geometric least squares means (LSMs) for AUC (0-inf) must have fallen within the BE limit of 0.8 and 1.25.|Ratio of Geometric LSMs (P3:P2)|0.937|||||2-Sided|90.0|0.842|1.042|||||||
1672068|NCT01357850|3076465|Superiority or Other||Mean Difference (Final Values)|0.18||||0.8942|2-Sided|95.0|-2.44|2.79|||ANOVA||||
1672069|NCT01357850|3076465|Superiority or Other||Mean Difference (Final Values)|-0.95||||0.5647|2-Sided|95.0|-4.22|2.32|||ANOVA||||
1672070|NCT01357850|3076465|Superiority or Other||Median Difference (Final Values)|-2.06||||0.2256|2-Sided|95.0|-5.43|1.3|||ANOVA||||
1672071|NCT01357850|3076466|Superiority or Other||Mean Difference (Final Values)|772.7||||0.5582|2-Sided|95.0|-1887.77|3433.17|||ANOVA||||
1672072|NCT01357850|3076466|Superiority or Other||Mean Difference (Final Values)|1278.77||||0.3375|2-Sided|95.0|-1398.13|3955.68|||ANOVA||||
1672073|NCT01357850|3076466|Superiority or Other||Mean Difference (Final Values)|134.89||||0.9343|2-Sided|95.0|-3172.05|3441.83|||ANOVA||||
1672074|NCT01357850|3076467|Superiority or Other||Mean Difference (Final Values)|0.0467||||0.1666|2-Sided|95.0|-0.0204|0.1137|||ANOVA||||
1672076|NCT01357850|3076467|Superiority or Other||Mean Difference (Final Values)|0.0119||||0.7873|2-Sided|95.0|-0.0768|0.1005|||ANOVA||||
1672077|NCT01357577|3076483|Other|||||||0.51||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.|||
1672078|NCT01357577|3076483|Other|||||||0.56||||||Interaction main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.|||
1672079|NCT01357577|3076483|Other|||||||0.71||||||Timepoint main effect.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.|||
1672080|NCT01357577|3076483|Other|||||||0.26||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.|||
1672081|NCT01357577|3076483|Other|||||||0.2||||||6-Month P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.|||
1672082|NCT01357577|3076483|Other|||||||0.48||||||Post-Treatment P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PHQ score.|||
1672083|NCT01357577|3076484|Other|||||||0.15||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.|||
1672084|NCT01357577|3076484|Other|||||||0.024||||||Interaction P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.|||
1672085|NCT01357577|3076484|Other|||||||0.63||||||Timepoint main effect P-Value|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.|||
1672086|NCT01357577|3076484|Other|||||||0.73||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.|||
1672087|NCT01357577|3076484|Other|||||||0.45||||||P-value at 6 months.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.|||
1672088|NCT01357577|3076484|Other|||||||0.18||||||Post-Treatment P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline PCL score.|||
1672089|NCT01357577|3076485|Other|||||||0.19||||||Site main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.|||
1672090|NCT01357577|3076485|Other|||||||0.47||||||Interaction P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.|||
1672091|NCT01357577|3076485|Other|||||||0.16||||||Timepoint main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.|||
1672092|NCT01357577|3076485|Other|||||||0.86||||||Treatment main effect P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.|||
1672093|NCT01357577|3076485|Other|||||||0.53||||||6-month P-Value.|Mixed Models Analysis|Mixed model p-values are adjusted for study site and baseline ASI (Drug Use) score.|||
1672094|NCT01357577|3076485|Other|||||||0.66||||||Post-treatment p-value.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and baseline ASI (drug score).|||
1672095|NCT01357577|3076486|Other|||||||0.16||||||Site main effect P-Value.|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.|||
1672096|NCT01357577|3076486|Other|||||||0.29||||||interaction|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.|||
1672097|NCT01357577|3076486|Other|||||||0.14||||||Timepoint main effect P-value|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.|||
1672098|NCT01357577|3076486|Other|||||||0.26||||||treatment main effect|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.|||
1672099|NCT01357577|3076486|Other|||||||0.84||||||6-month P-Value.|Mixed Models Analysis|Mixed-model p-values adjusted for study site and Baseline ASI (Alcohol Use) score.|||
1672100|NCT01357577|3076486|Other|mixed-effects linear regression model adjusted for study site and the baseline value of the dependent variable.||||||0.12||||||Post-treatment P-value.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and baseline ASI (Alcohol Use) score.|||
1672101|NCT01357577|3076487|Other|||||||0.12|||||||Mixed Models Analysis|The p-value shown above refers to the site main effect.|||
1672102|NCT01357577|3076487|Other|||||||0.005|||||||Mixed Models Analysis|The p-value shown above refers to the interaction.|||
1672103|NCT01357577|3076487|Other|||||||0.072||||||The p-value shown above refers to the timepoint main effect.|Mixed Models Analysis||||
1672104|NCT01357577|3076487|Other|||||||0.65||||||The p-value shown above refers to the treatment main effect.|Mixed Models Analysis||||
1672105|NCT01357577|3076487|Other|||||||0.12||||||The p-value shown above is for the 6-month time point.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and the baseline total CAPS score.|||
1672106|NCT01357577|3076487|Other|||||||0.48||||||P-Value show above is for post-assessment time point.|Mixed Models Analysis|Mixed-model p-values are adjusted for study site and the baseline total CAPS score.|||
1672107|NCT01357564|3076488|Superiority||Mean Difference (Net)|-0.1||||0.03|2-Sided|95.0|-0.14|-0.01|||t-test, 2 sided|||Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.|
1672108|NCT01357564|3076489|Superiority||Mean Difference (Net)|-0.72||||0.02|2-Sided|95.0|-1.23|-0.13|||t-test, 2 sided|||Sample size calculation was based on the main study hypothesis tested at 80% power for a 2-sided alternative hypothesis using a t-test comparing the treatment groups on 4-month values. Based on previous trials, we sought a medium effect size of 0.50 using a type I error rate of .05.|
1672109|NCT01357551|3076490|Superiority or Other||incidence rate ratio|1.07|Standard Error of the Mean|0.35||0.83|2-Sided|95.0|0.57|2.03|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 & 56, group X time interaction; negative binomial distribution with log link||The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of moderate physical activity per week at week 56 than those randomized to usual care.|
1672133|NCT01355523|3076605|Superiority or Other|||||||0.386|||||||Wilcoxon (Mann-Whitney)||||
1672134|NCT01355523|3076606|Superiority or Other|||||||0.93|||||||Wilcoxon (Mann-Whitney)||||
1672110|NCT01357551|3076491|Superiority or Other||incidence rate ratio|1.03|Standard Error of the Mean|0.26||0.91|2-Sided|95.0|0.63|1.68|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 & 56, group X time interaction; negative binomial distribution with log link||The hypothesis was that patients randomized to receive the maintenance intervention would have higher rates of walking per week at week 56 than those randomized to usual care.|
1672111|NCT01357551|3076492|Superiority or Other||Mean Difference (Net)|-125.49|Standard Error of the Mean|78.64||0.11|2-Sided|95.0|-280.71|29.72|||Mixed Models Analysis|Common intercept, initial weight loss stratum, indicators for week 26 & 56, group X time interaction||The hypothesis was that patients randomized to receive the maintenance intervention would have less caloric intake at week 56 than those randomized to usual care.|
1672112|NCT01357551|3076493|Superiority or Other||Mean Difference (Final Values)|1.61|Standard Error of the Mean|0.78||0.04|2-Sided|95.0|0.07|3.13||A priori threshold was p<.05|Mixed Models Analysis|Parameters included common intercept, initial weight loss stratum, dummy-coded time, and indicators for the maintenance X each follow-up time point||The sample size estimate was based on the primary hypothesis that patients randomized to receive the maintenance intervention would have less mean weight regain at week 56 than those randomized to usual care. The week 0 standard deviation was estimated as 24.6kg, the correlation between week 0 and week 56 as 0.95, and the week 56 dropout rate as 10%. To detect a difference of 3.5 kg with 90% power and a type I error rate of 5%, 230 total (115 in each group) randomized patients were needed.|
1672113|NCT01357161|3076510|Superiority or Other||Hazard Ratio (HR)|1.15||||0.8|2-Sided|95.0|0.4|3.34|||Cox proportional hazards model|||A stratified [number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (<12 months vs. ≥12 months)] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.|
1672114|NCT01357161|3076511|Superiority or Other||Difference in Response Rat|5.2||||0.5247|2-Sided|95.0|-10.9|21.1|||Miettinen and Nurminen’s Method|||Stratified Miettinen and Nurminen’s method with a two-sided p-Value for testing was used for comparison of the ORRs between the treatment groups in Part 2 portion of the study. A 95% confidence interval (CI) for the difference in response rates was provided.|
1672115|NCT01357161|3076512|Superiority or Other||Difference in Percentages|-1.3|||||2-Sided|95.0|-16.2|13.6||||||P-values and 95% confidence intervals were calculated using the Miettinen and Nurminen method for between-treatment differences (MK-1775 vs. placebo) in the percentage of participants with events.|
1672116|NCT01357161|3076513|Superiority or Other||Difference in Percentages|3.3|||||2-Sided|95.0|-2.9|11.4||||||P-values and 95% confidence intervals were calculated using the Miettinen and Nurminen method for between-treatment differences (MK-1775 vs. placebo) in the percentage of participants with events.|
1672117|NCT01357161|3076515|Superiority or Other||Hazard Ratio (HR)|0.55||||0.03|2-Sided|80.0|0.39|0.79|||Cox proportional hazards model|||A stratified [number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (<12 months vs. ≥12 months)] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.|
1672118|NCT01357161|3076517|Superiority or Other||Hazard Ratio (HR)|0.63||||0.08|2-Sided|80.0|0.45|0.89|||Cox proportional hazards model|||A stratified [number of prior platinum based regimens (1 vs. 2 and 3), time since last platinum based therapy (<12 months vs. ≥12 months)] Cox proportional hazards model, with Efron method of tie handling, was used to assess the magnitude of the treatment difference between the treatment arms. The p-value from the score test was used in the significance test and the hazard ratio (MK-1775 versus Placebo) and its 95% confidence interval from the same Cox model was reported.|
1672119|NCT01356940|3076528|Superiority or Other||Mean Difference (Final Values)|0.586||||0.586|2-Sided||||||Mixed Models Analysis||P values above 0.05 are considered statistically not significant in this study||
1672120|NCT01356277|3076568|Superiority|||||||0.45|||||||t-test, 2 sided||||
1672121|NCT01356277|3076569|Superiority|||||||0.26|||||||Chi-squared|||Rates were compared between intervention and control groups using Chi square|
1672122|NCT01356277|3076570|Superiority|||||||0.15|||||||t-test, 2 sided||||
1672123|NCT01356277|3076571|Superiority|||||||0.15|||||||t-test, 2 sided||||
1672124|NCT01356277|3076572|Superiority|||||||0.49|||||||Wilcoxon ranksum|||Null hypothesis was that there was no difference in the SD of tacrolimus trough levels between intervention and control.|
1672125|NCT01356277|3076573|Superiority||Odds Ratio (OR)|1.74||||0.003|2-Sided|95.0|1.21|2.5|||Regression, Logistic|Unadjusted ordinal logistic regression|An odds ratio greater than 1.0 indicates higher adherence in Intervention participants compared with controls.||
1672126|NCT01356277|3076574|Superiority||Odds Ratio (OR)|1.66||||0.006|2-Sided|95.0|1.15|2.39|||Regression, Logistic|Unadjusted, ordinal logistic regression|An odds ratio greater than 1.0 indicates higher adherence in Intervention participants compared with controls.|We estimated a sample size of 75 participants per group to have 85% power to detect a 20% difference in taking adherence between groups, using 2–sided tests and setting alpha at 0.05, assuming a common standard deviation of 40%. Targeted enrollment of 176 participants accounted for 15% drop-out. Only participants with electronic pillbox data could be included. For participants who withdrew or stopped using the pillbox, all available pillbox data were included.|
1672127|NCT01355796|3076582|Superiority||Mean Difference (Net)|1.49|Standard Error of the Mean|1.66|<|0.05|2-Sided|95.0|-1.76|4.75|||Mixed Models Analysis||||
1672128|NCT01355627|3076592|Superiority or Other||Odds Ratio (OR)|0.82|Standard Error of the Mean|0.23||0.485|||||||Regression, Logistic|Treatment and pooled centre as covariates.|< 1 implies a smaller likelihood of a TachoSil treated patient to experience a CSF leak.||
1672129|NCT01355523|3076601|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1672130|NCT01355523|3076602|Superiority or Other|||||||0.578|||||||Wilcoxon (Mann-Whitney)||||
1672131|NCT01355523|3076603|Superiority or Other|||||||0.339|||||||Wilcoxon (Mann-Whitney)||||
1672132|NCT01355523|3076604|Superiority or Other|||||||0.241|||||||Wilcoxon (Mann-Whitney)||||
1672143|NCT01355523|3076615|Superiority or Other|||||||0.125|||||||Fisher Exact||||
1672144|NCT01355523|3076616|Superiority or Other||Relative Risk|0.25|||||2-Sided|95.0|0.076|0.797|||||||
1672145|NCT01355523|3076616|Superiority or Other||Number need to treat|2.95|||||2-Sided|95.0|1.703|11.024|||||||
1672146|NCT01355523|3076616|Superiority or Other|||||||0.008|||||||Chi-squared||||
1672147|NCT01355471|3076619|Superiority or Other||||||<|0.001|||||||GEE: Logit link function|Generalized Estimation Equation (GEE) methods with Logit link function and marginal expectation model.|||
1672148|NCT01355458|3076620|Superiority or Other||||||<|0.001|||||||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.|||
1672149|NCT01355419|3076621|Superiority or Other||||||<|0.05||||||Multiple regression modelling was used to determine whether actigraphic or polysomnographic data were predictors for physical activity, independently from age and BMI, stepwise forward selection of variables was performed.|Regression, Linear|||Multiple regression modelling was used to determine whether actigraphic or polysomnographic data were predictors for physical activity, independently from age and BMI, stepwise forward selection of variables was performed.|
1672150|NCT01355419|3076622|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||A power analysis conducted prior to the study predicted that a sample of 144 patients would provide an 80% power to detect a mean difference in sleep time of 40 minutes, assuming a standard deviation of 85 minutes and using a two-sided significance level of 5%.|
1672151|NCT01355289|3076630|Superiority or Other||Difference in % of Responders|58.4||||0.0003|2-Sided|95.0|30.92|85.88|||Cochran-Mantel-Haenszel||||
1672152|NCT01355289|3076630|Superiority or Other||Difference in % of Responders|60.78||||0.0003|2-Sided|95.0|36.3|85.27|||Cochran-Mantel-Haenszel||||
1672153|NCT01355289|3076630|Superiority or Other||Difference in % of Responders|31.62||||0.0236|2-Sided|95.0|5.39|57.84|||Cochran-Mantel-Haenszel||||
1672154|NCT01355224|3076633|Superiority or Other|||||||0.0622|||||||Regression, Linear|Adjusted for age, gender, BMI, and baseline intent.|||
1672155|NCT01355224|3076634|Superiority or Other|||||||0.0365|||||||Regression, Linear|Adjusted for age, gender, BMI, and baseline intent.|||
1672156|NCT01355224|3076635|Superiority or Other|||||||0.015|||||||Regression, Linear|Adjusted for age, gender, BMI, baseline intention.|||
1672157|NCT01355081|3076641|Superiority or Other||Least square mean difference|-1.04|Standard Error of the Mean|1.233||0.4008|2-Sided|95.0|-3.461|1.387|||ANCOVA|Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.|||
1672158|NCT01355081|3076641|Superiority or Other||Least square means difference|-2.03|Standard Error of the Mean|1.241||0.1031|2-Sided|95.0|-4.467|0.413|||ANCOVA|Change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.|||
1672159|NCT01355068|3076645|Superiority or Other||Ratio of Adjusted Means|101.43|||||2-Sided|90.0|97.56|105.47||||||Natural log transformed AUC (0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1672160|NCT01355068|3076646|Superiority or Other||Ratio of Adjusted Means|102.2|||||2-Sided|90.0|97.18|107.47||||||Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1672161|NCT01355068|3076647|Superiority or Other||Ratio of Adjusted Means|101.33|||||2-Sided|90.0|97.85|104.94||||||Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1672162|NCT01354496|3076673|Superiority or Other||Ratio of geometric least squares means|0.94|||||2-Sided|90.0|0.891|0.993|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.||
1672163|NCT01354496|3076673|Superiority or Other||Ratio of geometric least squares means|0.98|||||2-Sided|90.0|0.926|1.04|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.||
1672164|NCT01354496|3076674|Superiority or Other||Ratio of geometric least squares means|0.943|||||2-Sided|90.0|0.905|0.983|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.||
1672165|NCT01354496|3076674|Superiority or Other||Ratio of geometric least squares means|0.993|||||2-Sided|90.0|0.951|1.04|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.||
1672166|NCT01354496|3076676|Superiority or Other||Ratio of geometric least squares means|1.01|||||2-Sided|90.0|0.882|1.15|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.||
1672167|NCT01354496|3076677|Superiority or Other||Ratio of geometric least squares means|1.02|||||2-Sided|90.0|0.896|1.16|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.||
1672168|NCT01354496|3076678|Superiority or Other||Ratio of geometric least squares means|1.06|||||2-Sided|90.0|0.922|1.22|||||Cmax was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.||
1672169|NCT01354496|3076679|Superiority or Other||Ratio of geometric least squares means|1.03|||||2-Sided|90.0|0.897|1.18|||||AUC0-∞ was log-transformed and analyzed using a linear mixed effects model with fixed factors for formulation, sequence, and period, and random factor for participant.||
1672170|NCT01354444|3076681|Other|||||||0.438|||||||Rank sum test|||This analysis compares the change in oligomeric Abeta between the treatment and placebo group from baseline to 6 months later.|
1672171|NCT01354444|3076681|Other|||||||0.314|||||||Rank sum test|||This analysis compares the change in p-tau between the treatment and placebo group from baseline to 6 months later.|
1672172|NCT01354444|3076681|Other|||||||0.0562|||||||Rank sum test|||This analysis compares the change in Abeta42 between the treatment and placebo group from baseline to 6 months later.|
1672173|NCT01354444|3076681|Other|||||||0.481|||||||Rank sum test|||This analysis compares the change in total Tau between the treatment and placebo group from baseline to 6 months later.|
1672174|NCT01354444|3076682|Other||Coefficient|1.48||||0.565|2-Sided|95.0|-3.796|6.761|||Regression, Linear|||This analysis compares immediate recall before and after 6 months between the treatment and placebo group.|
1672175|NCT01354431|3076683|Superiority or Other (legacy)||Cox Proportional Hazard|1.07|||||2-Sided|80.0|0.8|1.42|||||||
1672176|NCT01354431|3076683|Superiority or Other (legacy)||Cox Proportional Hazard|1.05|||||2-Sided|80.0|0.8|1.37|||||||
1672177|NCT01354431|3076683|Superiority or Other (legacy)||Cox Proportional Hazard|0.98|||||2-Sided|80.0|0.74|1.29|||||||
1672178|NCT01354431|3076684|Superiority or Other (legacy)||Cox Proportional Hazard|1.18|||||2-Sided|80.0|0.86|1.62|||||||
1672179|NCT01354431|3076684|Superiority or Other (legacy)||Cox Proportional Hazard|0.89|||||2-Sided|80.0|0.66|1.2|||||||
1672180|NCT01354431|3076684|Superiority or Other (legacy)||Cox Proportional Hazard|0.76|||||2-Sided|80.0|0.56|1.02|||||||
1672181|NCT01354431|3076686|Superiority or Other (legacy)|||||||1||||||Exact Cochran-Armitage trend test with 20% significance level (2-sided).|Cochran-Armitage Trend Test||||
1672182|NCT01354431|3076686|Superiority or Other (legacy)||Odds Ratio (OR)|0.86|||||2-Sided|80.0|0.43|1.77|||||||
1672183|NCT01354431|3076686|Superiority or Other (legacy)||Odds Ratio (OR)|0.89|||||2-Sided|80.0|0.43|1.83|||||||
1672184|NCT01354431|3076686|Superiority or Other (legacy)||Odds Ratio (OR)|1.18|||||2-Sided|80.0|0.59|2.37|||||||
1672185|NCT01354431|3076687|Superiority or Other (legacy)|||||||0.924||||||Stratified log rank trend test with 20% significance level (2-sided)|Log Rank||||
1672186|NCT01354431|3076687|Superiority or Other (legacy)||Cox Proportional Hazard|1.01|||||2-Sided|80.0|0.75|1.34|||||||
1672187|NCT01354431|3076687|Superiority or Other (legacy)||Cox Proportional Hazard|0.98|||||2-Sided|80.0|0.75|1.29|||||||
1672188|NCT01354431|3076687|Superiority or Other (legacy)||Cox Proportional Hazard|0.98|||||2-Sided|80.0|0.74|1.29|||||||
1672189|NCT01354314|3076716|Superiority|||||||0.672|||||||Regression, Linear||||
1672190|NCT01354314|3076716|Superiority|||||||0.368|||||||Regression, Linear||||
1672191|NCT01354314|3076716|Superiority|||||||0.267|||||||Regression, Linear||||
1672192|NCT01354314|3076717|Superiority|||||||0.48|||||||Regression, Linear||||
1672193|NCT01354314|3076717|Superiority|||||||0.178|||||||Regression, Linear||||
1672194|NCT01354314|3076717|Superiority|||||||0.327|||||||Regression, Linear||||
1672195|NCT01354314|3076718|Superiority|||||||0.282|||||||Regression, Linear||||
1672196|NCT01354314|3076718|Superiority|||||||0.153|||||||Regression, Linear||||
1672197|NCT01354314|3076718|Superiority|||||||0.673|||||||Regression, Linear||||
1672198|NCT01354314|3076719|Superiority|||||||0.712|||||||Regression, Linear||||
1672199|NCT01354314|3076719|Superiority|||||||0.594|||||||Regression, Linear||||
1672200|NCT01354314|3076719|Superiority|||||||0.893|||||||Regression, Linear||||
1672201|NCT01354132|3076741|Superiority|||||||0.9215|||||||t-test, 2 sided||||
1672202|NCT01354132|3076742|Superiority|||||||0.9403|||||||t-test, 2 sided||||
1672203|NCT01354132|3076743|Superiority|||||||0.3804|||||||t-test, 2 sided||||
1672204|NCT01354132|3076744|Superiority|||||||0.0043|||||||t-test, 2 sided||||
1672205|NCT01354132|3076745|Superiority|||||||0.9574|||||||t-test, 2 sided||||
1672206|NCT01354132|3076746|Superiority|||||||0.5622|||||||t-test, 2 sided||||
1672207|NCT01354132|3076747|Superiority|||||||0.8786|||||||t-test, 2 sided||||
1672208|NCT01354132|3076748|Superiority|||||||0.6732|||||||t-test, 1 sided||||
1672209|NCT01354132|3076749|Superiority|||||||0.9|||||||t-test, 2 sided||||
1672210|NCT01354132|3076750|Superiority|||||||0.33|||||||t-test, 2 sided||||
1672211|NCT01354132|3076751|Superiority|||||||0.05|||||||t-test, 2 sided||||
1672212|NCT01354132|3076752|Superiority|||||||0.741|||||||t-test, 2 sided||||
1672213|NCT01354132|3076753|Superiority|||||||0.464|||||||t-test, 2 sided||||
1672214|NCT01354132|3076754|Superiority|||||||0.876|||||||t-test, 2 sided||||
1672215|NCT01354132|3076755|Superiority|||||||0.153|||||||t-test, 2 sided||||
1672216|NCT01354132|3076756|Superiority|||||||0.27|||||||t-test, 2 sided||||
1672217|NCT01354132|3076757|Superiority|||||||0.022|||||||t-test, 2 sided|||Speed of Processing|
1672218|NCT01354132|3076758|Superiority|||||||0.71|||||||t-test, 2 sided||||
1672219|NCT01354132|3076759|Superiority|||||||0.52|||||||t-test, 2 sided||||
1672220|NCT01354132|3076760|Superiority|||||||0.39|||||||t-test, 2 sided||||
1672221|NCT01354132|3076761|Superiority|||||||0.5|||||||t-test, 2 sided||||
1672222|NCT01354028|3076763|Superiority or Other|||||||0.026||||||Pearson's chi square|Chi-squared|Degrees of freedom=1||"Null hypothesis: there is no difference in massage therapy or no massage therapy in number of infants who will be asleep at the end of massage or the corresponding time frame on the non massage day.~Pearson's chi square=4.98"|
1672223|NCT01354028|3076766|Superiority or Other|||||||0.1303|||||||Chi-squared|Degrees of freedom =1||"Null hypothesis: there will be no difference in sleep efficiency in preterm infants on the day of massage versus the day without massage.~Power calculation: the sample size was determined by convenience for this pilot study"|
1672224|NCT01354015|3076768|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Deviation|0.79||0.2539|2-Sided|95.0|||||ANOVA|||All statistical analysis used intent-to-treat methodology and all comparisons used a two-tailed test at the .05 level of significance. Continuous variables are reported as means and standard deviations. W|
1672225|NCT01353898|3076787|Superiority or Other||Mean Difference (Final Values)|-1.83|||||||||||||||
1672226|NCT01353898|3076787|Superiority or Other||Mean Difference (Final Values)|-0.53|||||||||||||||
1672227|NCT01353898|3076787|Superiority or Other||Mean Difference (Final Values)|-0.99|||||||||||||||
1672228|NCT01353898|3076787|Superiority or Other||Mean Difference (Final Values)|-0.54|||||||||||||||
1672229|NCT01353898|3076787|Superiority or Other||Mean Difference (Final Values)|-0.9|||||||||||||||
1672230|NCT01353898|3076788|Superiority or Other||Geometric Mean Ratio|0.84|||||||||||||Geometric mean ratio of HIV-1/Healthy. Analyzed using a linear mixed model with fixed factors: dose, health-status and the interaction between dose and health-status.|Compared to historical data for AUC0-24hrs measured on Day 7 for healthy participants treated with 800 mg MK-1972 once daily|
1672231|NCT01353898|3076788|Superiority or Other||Geometric Mean Ratio|0.62|||||||||||||Geometric mean ratio of HIV-1/Healthy. Analyzed using a linear mixed model with fixed factors: dose, health-status and the interaction between dose and health-status.|Compared to historical data for AUC0-24hrs measured on Day 7 for healthy participants treated with 200 mg MK-1972 once daily|
1672232|NCT01353586|3076828|Superiority or Other||Proportion of events|71.6|||||2-Sided|95.0|63.3|79.8|||||The above supplemental analysis is to estimate the rate of subjects without documented symptomatic AF at Day 240 using the Kaplan-Meier time-to-event analysis method to accommodate the censored information from the two withdrawn subjects.||
1672233|NCT01353222|3076854|Superiority||Hazard Ratio (HR)|1.141||||0.6188|2-Sided|95.0|0.679|1.918|||From a stratified log-rank test, stratif||Cox regression model with treatment as the independent variable, stratified by randomization strata. Hazard ratio with control as reference.||
1672234|NCT01353079|3076858|Superiority or Other||Mean Difference (Net)|-0.788|||<|0.05|2-Sided|95.0|-1.291|-0.284|||ANCOVA||||
1672235|NCT01353079|3076859|Superiority or Other||Mean Difference (Net)|-0.771|||<|0.05|2-Sided|95.0|-1.213|-0.329|||ANCOVA||||
1672236|NCT01353079|3076860|Superiority or Other||Mean Difference (Net)|-0.857|||<|0.05|2-Sided|95.0|-1.388|-0.326|||ANCOVA||||
1672237|NCT01353079|3076861|Superiority or Other||Mean Difference (Net)|-0.834|||<|0.05|2-Sided|95.0|-1.298|-0.369|||ANCOVA||||
1672238|NCT01352715|3076971|Non-Inferiority or Equivalence|Confidence interval estimation was stratified by randomization stratification factors using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified upper confidence bound for non-inferiority was 10 percentage points.|Cumulative probability difference|-3.4|||||2-Sided|95.0|-8.4|1.5||||||Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 48 cumulative probability of virologic failure with 95% confidence interval.|
1672239|NCT01352507|3076982|Superiority or Other||LS mean difference|0.18||||0.364|2-Sided|95.0|-0.2|0.55||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis||||
1672240|NCT01352507|3076983|Superiority or Other||LS mean difference|-0.14|||<|0.001|2-Sided|95.0|-0.19|-0.09||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis||||
1672241|NCT01352507|3076984|Superiority or Other||LS mean difference|0.13|||<|0.001|2-Sided|95.0|0.09|0.18||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis||||
1672242|NCT01352507|3076985|Superiority or Other||LS mean difference|1.23||||0.391|2-Sided|95.0|-1.58|4.04||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis||||
1672243|NCT01352507|3076986|Superiority or Other||LS mean difference|-0.01||||0.917|2-Sided|95.0|-0.18|0.16||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis||||
1672244|NCT01352507|3076987|Superiority or Other||LS Mean Difference|-0.05||||0.495|2-Sided|95.0|-0.19|0.09||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis||||
1672245|NCT01352507|3076988|Superiority or Other||LS mean difference|-0.01||||0.861|2-Sided|95.0|-0.22|0.19||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis||||
1672246|NCT01352507|3076990|Superiority or Other||LS mean difference|0.03||||0.102|2-Sided|95.0|-0.01|0.08||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis||||
1672247|NCT01352507|3076991|Superiority or Other||LS mean difference|0.01||||0.988|2-Sided|95.0|-1.35|1.37||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis||||
1672248|NCT01352507|3076992|Superiority or Other||Least Squares (LS) mean difference|0.02||||0.793|2-Sided|95.0|-0.11|0.15||P-Value and LS mean difference were from a crossover mixed effect model that included treatment, period, sequence, and site as fixed effects, baseline value of efficacy measure as covariate, and participant within sequence as random effect.|Mixed Models Analysis||||
1672249|NCT01352507|3076994|Superiority or Other||||||<|0.001|||||||Wilson Score method|||Null hypothesis (H0): The proportion of participants who chose tadalafil over sildenafil is equal to 0.5 (p = 0.5), versus alternative hypothesis (H1): p is not equal to 0.5 (2-sided test).|
1672250|NCT01352468|3076995|Superiority or Other|||||||0.57|||||||ANCOVA|Controlling for baseline scores|||
1672251|NCT01352468|3076996|Superiority or Other|||||||0.68|||||||ANCOVA|Controlling for baseline scores|||
1672252|NCT01352468|3076997|Superiority or Other|||||||0.35|||||||ANCOVA|Controlling for baseline scores|||
1672253|NCT01352221|3077016|Superiority||Mean Difference (Final Values)|2.15|Standard Error of the Mean|0.16|<|0.0001|1-Sided|97.5|1.82||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF Change in Haemoglobin Concentration from Baseline to Week 12|
1672254|NCT01352221|3077017|Superiority||Mean Difference (Final Values)|2.18|Standard Error of the Mean|0.17|<|0.0001|1-Sided|97.5|1.87||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS|
1672255|NCT01352221|3077028|Superiority||Mean Difference (Final Values)|1.73|Standard Error of the Mean|0.15|<|0.0001|1-Sided|97.5|1.43|||ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|ANCOVA||||
1672256|NCT01352221|3077029|Superiority||Mean Difference (Final Values)|1.04|Standard Error of the Mean|0.11|<|0.0001|1-Sided|97.5|0.82||||ANCOVA|||ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|
1672257|NCT01352221|3077033|Superiority||Mean Difference (Final Values)|2.18|Standard Error of the Mean|0.19|<|0.0001|1-Sided|97.5|1.81||||ANCOVA|||ANCOVA for primary endpoint, Change in Hb concentration from Baseline to Week 12 in double-blind phase, FAS|
1672258|NCT01352117|3077058|Superiority|||||||0.911||||||The critical value for the final analysis was adjusted for the three interim analyses conducted for the Data and Safety Monitoring Board (DSMB) review using the Haybittle-Peto guidelines, at the p-value cutoff of 0.0487.|Wilcoxon (Mann-Whitney)|Stratified Wilcoxon-Mann-Whitney test (asymptotic method) known as van Elteren test, stratification by screening CD4 (<200 vs. >=200 cells/mm^3).|||
1672259|NCT01351415|3077079|Superiority or Other||Stratified Hazard Ratio|0.69||||0.0326|2-Sided|90.0|0.52|0.92|||Stratified Log-Rank test|||TTP3: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.|
1672260|NCT01351415|3077079|Superiority or Other||Stratified Hazard Ratio|0.79||||0.0311|2-Sided|90.0|0.65|0.95|||Stratified Log-Rank test|||TTP2: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.|
1672261|NCT01351415|3077081|Superiority or Other||Stratified Hazard Ratio|0.29||||0.06|2-Sided|90.0|0.09|0.9|||Stratified Log-Rank test|||The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.|
1672262|NCT01351415|3077082|Superiority or Other||Estimated difference in Disease Control|0.0326||||0.0218|2-Sided|90.0|-0.0288|0.094|||Stratified Cochran-Mantel-Haenszel test|||The stratification factors for Cochran-Mantel-Haenszel test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.|
1672263|NCT01351415|3077083|Superiority or Other||Estimated difference in response rate|0.0237||||0.081|2-Sided|90.0|-0.0156|0.063|||Stratified Cochran-Mantel-Haenszel test|||The stratification factors for Cochran-Mantel-Haenszel test are the type of planned 2nd-line SoC treatment, the number of cycles of Bevacizumab maintenance treatment prior to PD1 and the smoking status.|
1672264|NCT01351415|3077084|Superiority or Other||Stratified Hazard Ratio|0.63||||0.0045|2-Sided|90.0|0.49|0.83|||Stratified Log-Rank test|||PFS 3: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to PD1 and the smoking status.|
1672265|NCT01351415|3077084|Superiority or Other||Stratified Hazard Ratio|0.83||||0.0573|2-Sided|90.0|0.7|0.98|||Stratified Log-Rank test|||PFS 2: The stratification factors for Log-Rank test are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to PD1 and the smoking status.|
1672266|NCT01351415|3077085|Superiority or Other||Stratified Hazard Ratio|0.84||||0.1044|2-Sided|90.0|0.71|1.0|||Stratified Log-Rank test|||The stratification factors for Log-Rank test and Hazard Ratio (HR) are the type of planned 2nd-line SoC treatment, the number of cycles of bevacizumab maintenance treatment prior to first PD and smoking status.|
1672267|NCT01351025|3077129|Superiority or Other|||||||0.508||||||Two-sided p-values of < 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes ([week 44 - week 24] - [week 20 - baseline]) in CD8+ T-cell activation percent (% CD38+/DR+ of CD8+)|
1672268|NCT01351025|3077130|Superiority or Other|||||||0.704||||||Two-sided p-values of < 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes ([week 44 - week 24] - [week 20 - baseline]) in log10 D-dimer|
1672269|NCT01351025|3077131|Superiority or Other|||||||0.495||||||Two-sided p-values of < 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|exact Wilcoxon rank sun test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes ([week 44 - week 24] - [week 20 - baseline]) in CD4+ T-cell activation percent (% CD38+/DR+ of CD4)|
1672270|NCT01351025|3077132|Superiority or Other|||||||0.94||||||Two-sided p-values of < 0.05 without adjustments for multiple testing were considered statistically significant.|Wilcoxon (Mann-Whitney)|Exact Wilcoxon rank sum test was used||The null hypothesis is that there is no difference between arm A and arm B in the differences of the changes ([week 44 - week 24] - [week 20 - baseline]) in log10 IL-6|
1672271|NCT01350973|3077152|Superiority or Other||LS Mean Difference|-11.35|||<|0.0001|2-Sided|95.0|-15.9442|-6.7637||An ANCOVA model was employed, using the baseline triglyceride level as covariate and the treatment group as an independent variable.|ANCOVA||||
1672272|NCT01350973|3077152|Superiority or Other||LS Mean Difference|0.37|||<|0.876|2-Sided|95.0|-4.2491|4.983||An ANCOVA model was employed, using the baseline triglyceride level as covariate and the treatment group as an independent variable.|ANCOVA||||
1672273|NCT01350934|3077154|Superiority or Other||Odds Ratio (OR)|0.0279|||<|0.001|2-Sided|95.0|0.0074|0.1048|||Cochran-Mantel-Haenszel|||Odds Ratio comparison of percentage of participants with <20 ng/mL of serum 25-hydroxyvitamin (OH) D between Fosamax Plus group and Calcitriol group.|
1672274|NCT01350934|3077155|Superiority or Other||LS mean difference|-51.96|||<|0.001|2-Sided|95.0|-58.77|-45.39|||Constrained longitudinal data analysis||||
1672275|NCT01350934|3077156|Superiority or Other||LS mean difference|-51.07|||<|0.001|2-Sided|95.0|-57.29|-44.99|||Constrained longitudinal data analysis||||
1672276|NCT01350934|3077157|Superiority or Other||LS mean difference|-52.03|||<|0.001|2-Sided|95.0|-59.04|-45.3|||Constrained longitudinal data analysis||||
1672277|NCT01350934|3077158|Superiority or Other||LS mean difference|-42.37|||<|0.001|2-Sided|95.0|-48.16|-36.67|||Constrained longitudinal data analysis||||
1672278|NCT01350934|3077159|Superiority or Other||Estimated Difference|2.92|Standard Error of the Mean|0.59|<|0.001|2-Sided|95.0|1.8|4.1|||Longitudinal data analysis||||
1672279|NCT01350934|3077160|Superiority or Other||Estimated Difference|1.95|Standard Error of the Mean|0.56|<|0.001|2-Sided|95.0|0.8|3.1|||Longitudinal data analysis||||
1672280|NCT01350804|3077172|Superiority or Other||Odds Ratio (OR)|2.02||||0.0152|2-Sided|95.0|1.1|3.5|||Regression, Logistic||||
1672281|NCT01350804|3077172|Superiority or Other||Odds Ratio (OR)|1.79||||0.0458|2-Sided|95.0|1.0|3.2|||Regression, Logistic||||
1672282|NCT01350544|3077176|Superiority||Odds Ratio (OR)|0.79||||0.005|2-Sided|95.0|0.69|0.91||a priori threshold for significance for p < .05|Mixed Models Analysis|||We used generalized linear mixed models predicting adherence at baseline and 1.5-, 3-, 4.5-, and 6-months post-baseline, with intervention , time, interaction between intervention and time, medical and socio-demographic covariates, and baseline viral load. Sample size was determined with a power analysis assuming .80 power and an alpha level of .05 that would allow for detection of a small-to-medium effect size in adherence between arms.|
1672283|NCT01350388|3077198|Superiority or Other|||||||0.35|||||||ANCOVA||||
1672284|NCT01350388|3077199|Superiority or Other|||||||0.13|||||||ANCOVA||||
1672285|NCT01350388|3077200|Superiority or Other|||||||0.88|||||||ANCOVA||||
1672286|NCT01350388|3077201|Superiority or Other|||||||0.23|||||||ANCOVA||||
1672287|NCT01350388|3077202|Superiority or Other|||||||0.73|||||||ANCOVA||||
1672288|NCT01350388|3077203|Superiority or Other|||||||0.84|||||||ANCOVA||||
1672289|NCT01350141|3077230|Superiority or Other||Odds Ratio (OR)|51.185||||0.0121|2-Sided|95.0|2.37|1107.57|||Regression, Logistic|||Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672290|NCT01350141|3077230|Superiority or Other||Odds Ratio (OR)|8.502||||0.1786|2-Sided|95.0|0.38|192.32|||Regression, Logistic|||Day 85: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672291|NCT01350141|3077230|Superiority or Other||Odds Ratio (OR)|23.442||||0.0025|2-Sided|95.0|3.03|181.11|||Regression, Logistic|||Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672292|NCT01350141|3077230|Superiority or Other||Odds Ratio (OR)|3.468||||0.2339|2-Sided|95.0|0.45|26.88|||Regression, Logistic|||Day 57: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672293|NCT01350141|3077230|Superiority or Other||Odds Ratio (OR)|591.174||||0.0014|2-Sided|95.0|11.68|29922.99|||Regression, Logistic|||Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672294|NCT01350141|3077230|Superiority or Other||Odds Ratio (OR)|5.647||||0.2928|2-Sided|95.0|0.22|142.04|||Regression, Logistic|||Day 29: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672295|NCT01350141|3077231|Superiority or Other||Odds Ratio (OR)|13.587||||0.007|2-Sided|95.0|2.04|90.4|||Regression, Logistic|||Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672296|NCT01350141|3077231|Superiority or Other||Odds Ratio (OR)|8.157||||0.0223|2-Sided|95.0|1.35|49.37|||Regression, Logistic|||Day 85 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672297|NCT01350141|3077231|Superiority or Other||Odds Ratio (OR)|21.36||||0.0445|2-Sided|95.0|1.08|422.94|||Regression, Logistic|||Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672298|NCT01350141|3077231|Superiority or Other||Odds Ratio (OR)|2.967||||0.5164|2-Sided|95.0|0.11|79.24|||Regression, Logistic|||Day 85 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672299|NCT01350141|3077231|Superiority or Other||Odds Ratio (OR)|15.257||||0.0042|2-Sided|95.0|2.36|98.42|||Regression, Logistic|||Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672300|NCT01350141|3077231|Superiority or Other||Odds Ratio (OR)|6.43||||0.0282|2-Sided|95.0|1.22|33.89|||Regression, Logistic|||Day 57 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672301|NCT01350141|3077231|Superiority or Other||Odds Ratio (OR)|13.486||||0.0104|2-Sided|95.0|1.84|98.61|||Regression, Logistic|||Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672302|NCT01350141|3077231|Superiority or Other||Odds Ratio (OR)|1.635||||0.6611|2-Sided|95.0|0.18|14.73|||Regression, Logistic|||Day 57 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672303|NCT01350141|3077231|Superiority or Other||Odds Ratio (OR)|47.326||||0.0006|2-Sided|95.0|5.26|426.01|||Regression, Logistic|||Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672304|NCT01350141|3077231|Superiority or Other||Odds Ratio (OR)|24.75||||0.0013|2-Sided|95.0|3.49|175.63|||Regression, Logistic|||Day 29 less than 100 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672575|NCT01346488|3077691|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy|
1672305|NCT01350141|3077231|Superiority or Other||Odds Ratio (OR)|72.518||||0.0057|2-Sided|95.0|3.48|1512.1|||Regression, Logistic|||Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672306|NCT01350141|3077231|Superiority or Other||Odds Ratio (OR)|7.825||||0.19|2-Sided|95.0|0.36|169.74|||Regression, Logistic|||Day 29 less than 70 mg/dL: Analysis was performed using logistic regression with covariates baseline LDL-C and statin tested along with the treatment.|
1672307|NCT01350141|3077232|Superiority or Other||LS Mean Difference|-46.42|Standard Error of the Mean|8.463|<|0.0001|2-Sided|95.0|-63.62|-29.22|||ANCOVA|||Analysis was performed using ANCOVA model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.|
1672308|NCT01350141|3077232|Superiority or Other||Least Squares (LS) Mean Difference|-21.81|Standard Error of the Mean|8.385|<|0.0137|2-Sided|95.0|-38.85|-4.77|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate.|
1672309|NCT01349920|3077272|Superiority or Other|||||||0.381|||||||Multiple Linear Regression|||Week 22|
1672310|NCT01349920|3077272|Superiority or Other|||||||0.071|||||||Multiple Linear Regression|||Week 6|
1672311|NCT01349192|3077372|Superiority||Proportion Difference (Final Values)|-0.2||||0.1205|2-Sided|95.0|-0.42|0.03||The a priori threshold for statistical significance was 0.05.|Chi-squared||Difference was calculated as proportion with a PE treated with MRSA active antibiotics in the treatment group minus the analogous proportion in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.||
1672312|NCT01349192|3077373|Superiority||Mean Difference (Final Values)|-9.42||||0.3683|2-Sided|95.0|-30.3|11.47||The a priori threshold for statistical significance was 0.05.|t-test, 2 sided||Mean difference was calculated as mean days of antibiotic use in the treatment group minus the mean days of antibiotic use in the observation group.||
1672313|NCT01349192|3077374|Superiority||Proportion Difference (Final Values)|0.09||||0.5463|2-Sided|95.0|-0.18|0.34||The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion using antibiotics in the treatment group minus the proportion using antibiotics in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.||
1672314|NCT01349192|3077375|Superiority||Proportion Difference (Final Values)|0.525||||0.0004|2-Sided|95.0|0.23|0.8||Test includes adjustment for two interim reviews of efficacy data. The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group.||
1672315|NCT01349192|3077375|Superiority||Proportion Difference (Final Values)|0.56||||0.0005|2-Sided|95.0|0.25|0.74||The a priori threshold for statistical significance was 0.05.|Chi-squared||Proportion difference was calculated as proportion negative for MRSA in the treatment group minus the proportion negative for MRSA in the observation group. 95% CI calculated using the Newcombe-Wilson method without continuity correction.||
1672316|NCT01348490|3077423|Other|||||||0.0028||||||1-sample t-test was used.|t-test, 1 sided||||
1672317|NCT01348490|3077424|Other||||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided||||
1672318|NCT01348490|3077428|Other|||||||0.8701||||||1-sample t-test was used.|t-test, 1 sided||||
1672319|NCT01348490|3077428|Other||||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided||||
1672320|NCT01348490|3077428|Other||||||<|0.6887||||||1-sample t-test was used.|t-test, 1 sided||||
1672321|NCT01348490|3077429|Other|1-sample t-test with null hypothesis mean >= 0||||||0.2019||||||1-sample t-test was used.|t-test, 1 sided||||
1672322|NCT01348490|3077429|Other|1-sample t-test with null hypothesis mean >= 0|||||<|0.0001||||||1-sample t-test was used.|t-test, 1 sided||||
1672323|NCT01348490|3077429|Other|1-sample t-test with null hypothesis mean >= 0|||||<|0.0163||||||1-sample t-test was used.|t-test, 1 sided||||
1672324|NCT01348490|3077429|Other|1-sample t-test with null hypothesis mean >= 0|||||<|0.025||||||1-sample t-test was used.|t-test, 1 sided||||
1672325|NCT01348425|3077430|Non-Inferiority or Equivalence|The equivalence margin is +/- 10%, type I error is assumed to be 0.05, with a power of 0.8.|Mean Difference (Final Values)|0.7|Standard Deviation|4.1|<|0.01|2-Sided|95.0|-2.0|3.5||Schuirman's TOST equivalence test on change in stent length upon deployment between longer and shorter stents.|t-test, 2 sided|To test the hypothesis whether the percent change in stent length is contained within [-10%, 10%].||The alternative hypothesis is equivalence in mean change in stent length upon deployment between longer and shorter stents, i.e., the difference in mean change between the longer and shorter stents is close to 0. Thus, a small p-value indicates a 95% confidence interval covers 0.|
1672326|NCT01347931|3077486|Superiority or Other||Mean Difference (Final Values)|3.0|Standard Deviation|4.0|<|0.05|2-Sided|95.0|1.0|7.0|||t-test, 2 sided|||Two-tailed t test|
1672327|NCT01347931|3077487|Superiority or Other||Mean Difference (Final Values)|4.0|Standard Deviation|7.0|<|0.05|2-Sided|95.0|2.0|10.0|||t-test, 2 sided|||A sample size of 26 patient pairs was determined based on the assumption of a true treatment difference in mean ADL endurance time of 4 ± 7 minutes using a two-tailed, paired t test (α=0.05, power=0.80).|
1672328|NCT01347879|3077493|Superiority or Other||Difference in least square means|-2.56||||0.7161|2-Sided|95.0|-16.5|11.3|||ANCOVA|Lesion count at baseline and center as covariate|||
1672329|NCT01347879|3077498|Superiority or Other|||||||0.0125|||||||Regression, Logistic||||
1672330|NCT01347879|3077499|Superiority or Other||Difference in least square means|-20.0||||0.0032|2-Sided|95.0|-33.2|-6.8|||ANCOVA|Lesion count at baseline and center as covariates|||
1672331|NCT01347879|3077500|Superiority or Other||Difference in least square means|-0.6||||0.8527|2-Sided|95.0|-6.6|5.5|||ANCOVA|Lesion count at baseline and center as covariates|||
1672332|NCT01347879|3077501|Superiority or Other||Difference in least square means|-7.35||||0.006|2-Sided|95.0|-12.5|-2.2|||ANCOVA|Lesion count at baseline and center as covariates|||
1672333|NCT01347710|3077563|Superiority or Other||||||<|0.001|||||||McNemar|p-Values are from 2-sided McNemar's test of comparison in proportion of patients with definitely diagnositic certainty between PET and SPECT|||
1672334|NCT01347710|3077564|Superiority or Other||||||<|0.001|||||||Log Rank||||
1674844|NCT01323010|3080714|Superiority or Other|||||||0.689|||||||Chi-squared||||
1672335|NCT01347710|3077565|Non-Inferiority or Equivalence|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.954||||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality excellent/good|z Test|p-Value based on on-sided z test for non-inferiority for specificity|||
1672336|NCT01347710|3077566|Non-Inferiority or Equivalence|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study protocol number BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.945||||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI|Z Test|one-sided z test for non-inferiority for specificity|||
1672337|NCT01347710|3077567|Superiority or Other||||||<|0.001||||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule; image quality of excellent or good|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity|||
1672338|NCT01347710|3077568|Non-Inferiority or Equivalence|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.827||||||p-Value of specificity for comparison of flurpiridaz F18 PET MPI vs. SPECT MPI in detecting multivessel disease|z test|p-Value based on one-sided z test for non-inferiority|||
1672339|NCT01347710|3077569|Superiority or Other||||||<|0.001||||||p-Value of sensitivity for flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule; multivessel disease|McNemar|p-Value based on two-sided McNemar's (Chi squared) test superiority|||
1672340|NCT01347710|3077570|Non-Inferiority or Equivalence|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.984||||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD|z Test|z test for non-inferiority for specificity; non-LAD|||
1672341|NCT01347710|3077570|Non-Inferiority or Equivalence|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.442||||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA|z Test|z test for non-inferiority for specificity; RCA|||
1672342|NCT01347710|3077570|Non-Inferiority or Equivalence|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.358||||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX|Z Test|z test for non-inferiority for specificity; LCX|||
1672343|NCT01347710|3077570|Non-Inferiority or Equivalence|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.379||||||p-Value for specificity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD|z Test|z test for non-inferiority for specificity; LAD|||
1672344|NCT01347710|3077571|Superiority or Other||||||<|0.001||||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; Non-LAD|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; Non-LAD|||
1672345|NCT01347710|3077571|Superiority or Other||||||<|0.001||||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; RCA|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; RCA|||
1672346|NCT01347710|3077571|Superiority or Other||||||<|0.001||||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LCX|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority for sensitivity; LCX|||
1672347|NCT01347710|3077571|Superiority or Other||||||<|0.001||||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI and SPECT MPI for majority rule in the localization of coronary artery disease; LAD|McNemar|Two-sided McNemar (chi-squared) test superiority for sensitivity; LAD|||
1672348|NCT01347710|3077572|Non-Inferiority or Equivalence|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.538||||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule BMI >/=30|z test|z test for non-inferiority for specificity|||
1672349|NCT01347710|3077572|Non-Inferiority or Equivalence|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.546||||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in female patients|z test|z test for non-inferiority for specificity|||
1672350|NCT01347710|3077572|Non-Inferiority or Equivalence|Systematic review of literature and meta-analysis of diagnostic efficacy of SPECT MPI to evaluate the performance criteria of SPECT MPI in studies with various levels of control. Analysis of study BMS747158-201. Non-inferiority margin (delta) = 7%||||||0.891||||||p-Value for specificity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in patients undergoing pharmacologic stress|Z test|z test for non inferiority for specificity|||
1672351|NCT01347710|3077573|Superiority or Other||||||<|0.001||||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients with BMI >/=30|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority|||
1672352|NCT01347710|3077573|Superiority or Other||||||<|0.001||||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs. SPECT MPI for majority rule in females|McNemar|p-Value based on two-sided McNemar's (Chi-squared) test superiority|||
1672353|NCT01347710|3077573|Superiority or Other||||||<|0.001||||||p-Value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule in patients under going pharmacologic stress|McNemar|Two-sided McNemar's (chi-squared) test superiority|||
1672354|NCT01347710|3077574|Superiority or Other||||||<|0.001||||||P-value for sensitivity comparison of flurpiridaz F18 PET MPI vs SPECT MPI for majority rule|McNemar|Two-sided McNemar's (chi-squared) test superiority|||
1672355|NCT01347580|3077581|Superiority or Other||Odds Ratio (OR)|0.803||||0.166|2-Sided|95.0|0.588|1.096|||Regression, Logistic||||
1672356|NCT01347580|3077582|Superiority or Other||Odds Ratio (OR)|1.225||||0.0547|2-Sided|95.0|0.996|1.506|||Regression, Logistic||||
1672357|NCT01347580|3077583|Superiority or Other||Odds Ratio (OR)|1.132||||0.344|2-Sided|95.0|0.876|1.462|||Regression, Logistic||||
1672358|NCT01347580|3077584|Superiority or Other||Odds Ratio (OR)|0.189||||0.0307|2-Sided|95.0|0.042|0.856|||Regression, Logistic||||
1672359|NCT01347580|3077585|Superiority or Other||Odds Ratio (OR)|1.215||||0.4168|2-Sided|95.0|0.76|1.942|||Regression, Logistic||||
1672360|NCT01347580|3077586|Superiority or Other||Odds Ratio (OR)|1.027||||0.9056|2-Sided|95.0|0.661|1.595|||Regression, Logistic||||
1672361|NCT01347580|3077587|Superiority or Other||Odds Ratio (OR)|1.074||||0.6322|2-Sided|95.0|0.801|1.441||P value at 0.025 adjusted for multiple comparisons|Regression, Logistic||||
1672362|NCT01347580|3077588|Superiority or Other||Odds Ratio (OR)|1.03||||0.8214|2-Sided|95.0|0.799|1.327||pvalue at 0.025 , adjusted for multiple comparisons|Regression, Logistic||||
1672363|NCT01347112|3077600|Superiority or Other||Mean Difference (Final Values)|-1.3|||||2-Sided|90.0|-4.7|2.1|||||data were analyzed using analysis of covariance with treatment as the independent variable and the baseline value included as the co-variate||
1672364|NCT01347112|3077601|Superiority or Other|||||||0.044||||||1 tailed fisher's exact|Fisher Exact|1 tailed|||
1672365|NCT01347112|3077602|Superiority or Other|||||||0.034||||||1 tailed fisher's exact test|Fisher Exact|1 tailed|||
1672366|NCT01347060|3077622|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1672367|NCT01347060|3077623|Superiority or Other||Mean Difference (Net)|883.23||||0.001|2-Sided|95.0|731.66|1041.69||The P-value is on the adjusted difference in total asthma costs.|Regression, Linear|Generalized Linear Model with a log-link and a gamma distribution adjusting for differences at baseline|||
1672368|NCT01347060|3077624|Superiority or Other||Hazard Ratio (HR)|0.8||||0.0051|2-Sided|95.0|0.68|0.93||The P-value relates to differences in combined inpatient/emergency department.|Regression, Cox|Adjusted for baseline differences|||
1672369|NCT01346839|3077636|Superiority or Other||||||<|0.05|||||||Regression, Cox||||
1672370|NCT01346592|3077653|Superiority or Other||GMT ratio (B strain)|1.95|||||2-Sided|95.0|1.65|2.29||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was >1.0|
1672371|NCT01346592|3077653|Superiority or Other||GMT ratio (H3N2 strain)|2.4|||||2-Sided|95.0|2.15|2.68||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was >1.0|
1672372|NCT01346592|3077653|Superiority or Other||GMT ratio (H1N1 strain)|3.82||||||95.0|3.14|4.64||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was >1.0|
1672373|NCT01346592|3077653|Superiority or Other||GMT ratio (B strain)|2.03|||||2-Sided|95.0|1.73|2.39||||||statistically significantly greater response was concluded if the lower bound of the 95% CI around the vaccine group ratio was >1.0|
1672374|NCT01346592|3077653|Superiority or Other||GMT ratio (H3N2 strain)|1.95|||||2-Sided|95.0|1.74|2.18||||||statistically significantly greater response was concluded if the lower bound of the 95% confidence interval around the vaccine group ratio is >1.0|
1672375|NCT01346592|3077653|Superiority or Other||GMT ratio (H1N1 strain)|4.07|||||2-Sided|95.0|3.34|4.95||||||GMTs were considered to be statistically significantly higher if the lower bound of the 95% confidence interval around the vaccine group ratio was >1.0|
1672376|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|0.71|||||2-Sided|95.0|0.23|2.16||||||At risk subjects.|
1672377|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.98|||||2-Sided|95.0|0.49|7.92||||||At risk subjects.|
1672378|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.48|||||2-Sided|95.0|0.34|18.0||||||At risk subjects.|
1672379|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.59|||||2-Sided|95.0|1.24|2.04||||||No risk subjects|
1672380|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.76|||||2-Sided|95.0|1.26|2.46||||||No risk subjects.|
1672381|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.24|||||2-Sided|95.0|1.48|3.39||||||No risk subjects|
1672382|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.45|||||2-Sided|95.0|0.53|3.94||||||At risk subjects.|
1672383|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.16|||||2-Sided|95.0|0.33|4.01||||||At risk subjects.|
1672384|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.73|||||2-Sided|95.0|0.29|10.0||||||At risk subjects.|
1672385|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.68|||||2-Sided|95.0|1.3|2.15||||||No risk subjects.|
1672386|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.59|||||2-Sided|95.0|1.14|2.22||||||No risk subjects.|
1672387|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.35|||||2-Sided|95.0|0.89|2.04||||||No risk subjects.|
1672388|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.69|||||2-Sided|95.0|1.67|8.15||||||At risk subjects.|
1672389|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|4.32|||||2-Sided|95.0|1.43|13.0||||||At risk subjects.|
1672390|NCT01346592|3077656|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|GMT ratio (H1N1 strain)|1.4|||||2-Sided|95.0|0.45|4.4||||||At risk subjects.|
1672391|NCT01346592|3077656|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|GMT ratio (B strain)|4.01|||||2-Sided|95.0|3.46|4.65||||||No risk subjects.|
1672392|NCT01346592|3077656|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|GMT ratio (H3N2 strain)|2.78|||||2-Sided|95.0|2.29|3.37||||||No risk subjects.|
1672393|NCT01346592|3077656|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|GMT ratio (H1N1 strain)|3.67|||||2-Sided|95.0|2.97|4.54||||||No risk subjects.|
1672394|NCT01346592|3077656|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|GMT ratio (B strain)|1.4|||||2-Sided|95.0|0.45|4.4||||||At risk subjects.|
1672395|NCT01346592|3077656|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|GMT ratio (H3N2 strain)|2.86|||||2-Sided|95.0|0.94|8.66||||||At risk subjects.|
1672396|NCT01346592|3077656|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|GMT ratio (H1N1 strain)|1.4|||||2-Sided|95.0|0.45|4.4||||||At risk subjects.|
1672397|NCT01346592|3077656|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|GMT ratio (B strain)|3.73|||||2-Sided|95.0|3.22|4.33||||||No risk subjects.|
1672398|NCT01346592|3077656|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|GMT ratio (H3N2 strain)|2.08|||||2-Sided|95.0|1.71|2.52||||||No risk subjects.|
1672399|NCT01346592|3077656|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|GMT ratio (H1N1 strain)|2.59|||||2-Sided|95.0|2.1|3.21||||||No risk subjects.|
1672400|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.1|||||2-Sided|95.0|1.1|3.98||||||At risk subjects.|
1672401|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.22|||||2-Sided|95.0|1.38|7.51||||||At risk subjects.|
1672402|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.71|||||2-Sided|95.0|0.65|4.5||||||At risk subjects.|
1672403|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.08|||||2-Sided|95.0|2.72|3.49||||||No risk subjects|
1672404|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.07|||||2-Sided|95.0|1.75|2.45||||||No risk subjects|
1672405|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|3.33|||||2-Sided|95.0|2.77|4.01||||||No risk subjects.|
1672406|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.5|||||2-Sided|95.0|1.34|4.67||||||At risk subjects.|
1672407|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.02|||||2-Sided|95.0|0.89|4.61||||||At risk subjects.|
1672408|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.53|||||2-Sided|95.0|0.6|3.93||||||At risk subjects.|
1672409|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.92|||||2-Sided|95.0|2.57|3.31||||||No risk subjects.|
1672410|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H3N2 strain)|1.6|||||2-Sided|95.0|1.35|1.89||||||No risk subjects.|
1672411|NCT01346592|3077656|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H1N1 strain)|2.29|||||2-Sided|95.0|1.91|2.76||||||No risk subjects.|
1672412|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|0.0|||||2-Sided|95.0|-26.9|31.0||||||At risk subjects.|
1672413|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|-9.0|||||2-Sided|95.0|-38.6|23.4||||||At risk subjects.|
1672414|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|-5.0|||||2-Sided|95.0|-41.7|35.0||||||At risk subjects.|
1672415|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|4.0|||||2-Sided|95.0|0.0|9.6||||||No risk subjects.|
1672416|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|8.0|||||2-Sided|95.0|2.2|15.6||||||No risk subjects.|
1672417|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|10.0|||||2-Sided|95.0|3.0|18.5||||||No risk subjects.|
1672418|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|21.0|||||2-Sided|95.0|-7.9|48.1||||||At risk subjects.|
1672419|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|-9.0|||||2-Sided|95.0|-38.4|14.3||||||At risk subjects.|
1672420|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|-6.0|||||2-Sided|95.0|-40.7|27.9||||||At risk subjects.|
1672421|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|6.0|||||2-Sided|95.0|1.5|12.5||||||No risk subjects.|
1672422|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|3.0|||||2-Sided|95.0|-1.8|10.0||||||No risk subjects.|
1672423|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|2.0|||||2-Sided|95.0|-3.8|9.5||||||No risk subjects.|
1672424|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|10.0|||||2-Sided|95.0|-14.0|29.3||||||At risk subjects.|
1672425|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|11.0|||||2-Sided|95.0|-14.9|33.5||||||At risk subjects.|
1672426|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|-2.0|||||2-Sided|95.0|-28.5|20.2||||||At risk subjects.|
1672427|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|15.0|||||2-Sided|95.0|11.9|18.3||||||No risk subjects.|
1672428|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|7.0|||||2-Sided|95.0|4.6|9.8||||||No risk subjects|
1672429|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|16.0|||||2-Sided|95.0|12.6|20.1||||||No risk subjects.|
1672430|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|2.0|||||2-Sided|95.0|-20.7|19.7||||||At risk subjects.|
1672431|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|11.0|||||2-Sided|95.0|-14.9|33.5||||||At risk subjects.|
1672432|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|-2.0|||||2-Sided|95.0|-28.5|20.2||||||At risk subjects.|
1672433|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|12.0|||||2-Sided|95.0|9.2|15.3||||||No risk subjects.|
1672434|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|5.0|||||2-Sided|95.0|2.5|7.4||||||No risk subjects.|
1672435|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|12.0|||||2-Sided|95.0|8.2|15.3||||||No risk subjects.|
1672436|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group differences (B strain)|8.0|||||2-Sided|95.0|-7.8|23.2||||||At risk subjects.|
1672437|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|6.0|||||2-Sided|95.0|-12.7|24.2||||||At risk subjects.|
1672438|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|-4.0|||||2-Sided|95.0|-25.3|15.4||||||At risk subjects|
1672439|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|13.0|||||2-Sided|95.0|10.5|16.1||||||No risk subjects.|
1672440|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|7.0|||||2-Sided|95.0|4.2|9.1||||||No risk subjects.|
1672441|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|15.0|||||2-Sided|95.0|11.3|18.1||||||No risk subjects.|
1672442|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|9.0|||||2-Sided|95.0|-6.8|23.4||||||At risk subjects.|
1672443|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|4.0|||||2-Sided|95.0|-14.4|20.7||||||At risk subjects.|
1672444|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|-4.0|||||2-Sided|95.0|-24.7|14.9||||||At risk subjects.|
1672445|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|11.0|||||2-Sided|95.0|8.6|13.9||||||No risk subjects.|
1672446|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|4.0|||||2-Sided|95.0|1.8|6.4||||||No risk subjects.|
1672447|NCT01346592|3077657|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|10.0|||||2-Sided|95.0|6.4|12.8||||||No risk subjects.|
1672448|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|0.0|||||2-Sided|95.0|-29.0|36.8||||||At risk subjects.|
1672449|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|-10.0|||||2-Sided|95.0|-41.5|28.7||||||At risk subjects|
1672450|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|-1.0|||||2-Sided|95.0|-42.1|43.0||||||At risk subjects.|
1672451|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|4.0|||||2-Sided|95.0|0.0|10.0||||||No risk subjects.|
1672452|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|8.0|||||2-Sided|95.0|2.0|16.1||||||No risk subjects.|
1672453|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|8.0|||||2-Sided|95.0|1.0|16.4||||||No risk subjects.|
1672454|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|25.0|||||2-Sided|95.0|-7.1|53.9||||||At risk subjects.|
1672455|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|-10.0|||||2-Sided|95.0|-41.2|16.6||||||At risk subjects.|
1672456|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|-5.0|||||2-Sided|95.0|-42.4|32.0||||||At risk subjects.|
1672457|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|8.0|||||2-Sided|95.0|2.9|15.1||||||No risk subjects.|
1672458|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 subjects)|4.0|||||2-Sided|95.0|-1.2|11.9||||||No risk subjects.|
1672459|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|2.0|||||2-Sided|95.0|-4.2|10.4||||||No risk subjects.|
1672460|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|16.0|||||2-Sided|95.0|-10.7|38.0||||||At risk subjects.|
1672461|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|10.0|||||2-Sided|95.0|-23.5|37.2||||||At risk subjects|
1672462|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|2.0|||||2-Sided|95.0|-27.1|25.5||||||At risk subjects|
1672463|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|15.0|||||2-Sided|95.0|12.0|18.6||||||No risk subjects|
1672464|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|8.0|||||2-Sided|95.0|5.1|10.5||||||No risk subjects|
1672465|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|16.0|||||2-Sided|95.0|12.4|20.2||||||No risk subjects.|
1672466|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|9.0|||||2-Sided|95.0|-16.9|27.1||||||At risk subjects.|
1672467|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|5.0|||||2-Sided|95.0|-26.9|30.3||||||At risk subjects.|
1672468|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|5.0|||||2-Sided|95.0|-24.7|26.3||||||At risk subjects.|
1672469|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|13.0|||||2-Sided|95.0|9.5|15.8||||||No risk subjects.|
1672470|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|5.0|||||2-Sided|95.0|2.6|7.5||||||No risk subjects.|
1672471|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|11.0|||||2-Sided|95.0|7.2|14.5||||||No risk subjects.|
1672472|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|12.0|||||2-Sided|95.0|-4.4|29.2||||||At risk subjects.|
1672473|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|6.0|||||2-Sided|95.0|-17.5|27.3||||||At risk subjects.|
1672474|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|-3.0|||||2-Sided|95.0|-26.1|19.2||||||At risk subjects.|
1672475|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|13.0|||||2-Sided|95.0|10.7|16.4||||||No risk subjects|
1672476|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|7.0|||||2-Sided|95.0|4.6|9.8||||||No risk subjects.|
1672477|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|14.0|||||2-Sided|95.0|10.7|17.7||||||No risk subjects.|
1672478|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|14.0|||||2-Sided|95.0|-1.6|29.5||||||At risk subjects.|
1672479|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|1.0|||||2-Sided|95.0|-21.2|18.9||||||At risk subjects.|
1672480|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H1N1 strain)|-1.0|||||2-Sided|95.0|-24.0|18.7||||||At risk subjects.|
1672481|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (B strain)|12.0|||||2-Sided|95.0|9.2|14.8||||||No risk subjects.|
1672482|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%.|Group difference (H3N2 strain)|4.0|||||2-Sided|95.0|1.8|6.6||||||No risk subjects.|
1672483|NCT01346592|3077658|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of confidence interval for day 50 vaccine group difference was > -10%|Group difference (H1N1 strain)|9.0|||||2-Sided|95.0|5.4|12.0||||||No risk subjects.|
1672484|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.17|||||2-Sided|95.0|0.37|3.67||||||At risk subjects|
1672485|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.81|||||2-Sided|95.0|1.61|4.89||||||At risk subjects|
1672486|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.12|||||2-Sided|95.0|0.58|7.71||||||At risk subjects.|
1672487|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.7|||||2-Sided|95.0|1.36|2.11||||||No risk subjects|
1672488|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.54|||||2-Sided|95.0|1.29|1.85||||||No risk subjects.|
1672489|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.4|||||2-Sided|95.0|1.89|3.05||||||No risk subjects|
1672490|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.82|||||2-Sided|95.0|0.73|4.54||||||At risk subjects|
1672576|NCT01346488|3077691|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48|
1672491|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.78|||||2-Sided|95.0|1.09|2.89||||||At risk subjects|
1672492|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.76|||||2-Sided|95.0|0.57|5.4||||||At risk subjects|
1672493|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|1.9|||||2-Sided|95.0|1.52|2.38||||||No risk subjects|
1672494|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|1.51|||||2-Sided|95.0|1.26|1.82||||||No risk subjects|
1672495|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|1.55|||||2-Sided|95.0|1.21|1.97||||||No risk subjects.|
1672496|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|5.26|||||2-Sided|95.0|2.32|12.0||||||At risk subjects.|
1672497|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.5|||||2-Sided|95.0|1.85|6.62||||||At risk subjects.|
1672498|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.72|||||2-Sided|95.0|1.02|7.31||||||At risk subjects.|
1672499|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.97|||||2-Sided|95.0|3.42|4.61||||||No risk subjects.|
1672500|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.68|||||2-Sided|95.0|2.4|2.99||||||No risk subjects|
1672501|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|3.66|||||2-Sided|95.0|3.05|4.39||||||No risk subjects.|
1672502|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|5.55|||||2-Sided|95.0|2.52|12.0||||||At risk subjects|
1672503|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.93|||||2-Sided|95.0|1.57|5.45||||||At risk subjects.|
1672504|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.34|||||2-Sided|95.0|0.92|6.0||||||At risk subjects.|
1672505|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.74|||||2-Sided|95.0|3.22|4.34||||||No risk subjects|
1672506|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.04|||||2-Sided|95.0|1.83|2.28||||||No risk subjects.|
1672507|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.81|||||2-Sided|95.0|2.34|3.37||||||No risk subjects.|
1672508|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|2.76|||||2-Sided|95.0|1.44|5.3||||||At risk subjects.|
1672509|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|3.25|||||2-Sided|95.0|2.09|5.06||||||At risk subjects.|
1672510|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.7|||||2-Sided|95.0|1.28|5.68||||||At risk subjects.|
1672511|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.14|||||2-Sided|95.0|2.78|3.56||||||No risk subjects.|
1672512|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.36|||||2-Sided|95.0|2.15|2.59||||||No risk subjects.|
1672513|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratios (H1N1 strain)|3.52|||||2-Sided|95.0|3.03|4.1||||||No risk subjects.|
1672514|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.46|||||2-Sided|95.0|1.88|6.34||||||At risk subjects|
1672577|NCT01346488|3077691|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36|
1672515|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H3N2 strain)|2.45|||||2-Sided|95.0|1.61|3.72||||||At risk subjects.|
1672516|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (H1N1 strain)|2.21|||||2-Sided|95.0|1.11|4.42||||||At risk subjects.|
1672517|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT ratio (B strain)|3.04|||||2-Sided|95.0|2.68|3.44||||||No risk subjects.|
1672518|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H3N2 strain)|1.87|||||2-Sided|95.0|1.7|2.05||||||No risk subjects.|
1672519|NCT01346592|3077659|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower limit of the 2-sided 97.6% confidence interval of the postvaccination (day 50) ratio of GMTs was above 0.667.|GMT Ratio (H1N1 strain)|2.68|||||2-Sided|95.0|2.3|3.12||||||No risk subjects.|
1672520|NCT01346592|3077664|Superiority or Other||Group difference (B strain)|10.9|||||2-Sided|95.0|8.3|13.4||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%|
1672521|NCT01346592|3077664|Superiority or Other||Group difference (H3N2 strain)|6.8|||||2-Sided|95.0|4.5|9.1||||||superiority was concluded if the lower bound of 95% CI of day 50 vaccine group difference,for at least 2 homologous strains, was >10%|
1672522|NCT01346592|3077664|Superiority or Other||Group difference (H1N1 strain)|14.4|||||2-Sided|95.0|11.1|17.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%|
1672523|NCT01346592|3077664|Superiority or Other||Group difference (B strain)|10.7|||||2-Sided|95.0|8.1|13.3||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%|
1672524|NCT01346592|3077664|Superiority or Other||Group difference (H3N2 strain)|3.9|||||2-Sided|95.0|1.8|5.9||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%|
1672525|NCT01346592|3077664|Superiority or Other||Group difference (H1N1 strain)|9.3|||||2-Sided|95.0|6.3|12.4||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%|
1672526|NCT01346592|3077665|Superiority or Other||GMT Ratio (B strain)|3.08|||||2-Sided|95.0|2.73|3.47||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5|
1672527|NCT01346592|3077665|Superiority or Other||GMT Ratio (H3N2 strain)|2.4|||||2-Sided|95.0|2.19|2.62||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5|
1672528|NCT01346592|3077665|Superiority or Other||GMT Ratio (H1N1 strain)|3.21|||||2-Sided|95.0|2.79|3.71||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5|
1672529|NCT01346592|3077665|Superiority or Other||GMT Ratio (B strain)|2.93|||||2-Sided|95.0|2.6|3.3||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5|
1672530|NCT01346592|3077665|Superiority or Other||GMT Ratio (H3N2 strain)|1.88|||||2-Sided|95.0|1.72|2.06||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5|
1672531|NCT01346592|3077665|Superiority or Other||GMT Ratio (H1N1 strain)|2.38|||||2-Sided|95.0|2.07|2.75||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5|
1672532|NCT01346592|3077666|Superiority or Other||Group difference (B strain)|18.8|||||2-Sided|95.0|14.4|23.1||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%|
1672533|NCT01346592|3077666|Superiority or Other||Group difference (H3N2 strain)|5.6|||||2-Sided|95.0|2.5|8.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%|
1672534|NCT01346592|3077666|Superiority or Other||Group difference (H1N1 strain)|17.7|||||2-Sided|95.0|12.9|22.6||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%|
1672535|NCT01346592|3077666|Superiority or Other||Group difference (B strain)|12.8|||||2-Sided|95.0|8.9|16.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%|
1672536|NCT01346592|3077666|Superiority or Other||Group difference (H3N2 strain)|2.5|||||2-Sided|95.0|-0.12|5.1||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%|
1672537|NCT01346592|3077666|Superiority or Other||Group difference (H1N1 strain)|10.4|||||2-Sided|95.0|6.1|14.7||||||superiority was concluded if the lower limit of the confidence interval of day 50 vaccine group difference,for at least 2 homologous strains, was >10%|
1672538|NCT01346592|3077667|Superiority or Other||GMT ratio (B strain)|4.64|||||2-Sided|95.0|3.86|5.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5|
1672539|NCT01346592|3077667|Superiority or Other||GMT ratio (H3N2 strain)|3.1|||||2-Sided|95.0|2.69|3.56||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5|
1672540|NCT01346592|3077667|Superiority or Other||GMT ratio (H1N1 strain)|5.28|||||2-Sided|95.0|4.16|6.7||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5|
1672541|NCT01346592|3077667|Superiority or Other||GMT ratio (B strain)|4.64|||||2-Sided|95.0|3.86|5.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5|
1672542|NCT01346592|3077667|Superiority or Other||GMT ratio (H3N2 strain)|2.25|||||2-Sided|95.0|1.96|2.59||||||superiority was concluded if the lower limit of the confidence interval of the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5|
1672543|NCT01346592|3077667|Superiority or Other||GMT ratio (H1N1 strain)|3.63|||||2-Sided|95.0|2.86|4.6||||||Superiority was concluded if the lower limit of the confidence interval for the day 50 vaccine group GMT ratios for at least 2 homologous strains was >1.5.|
1672544|NCT01346592|3077668|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was > -10%|Group difference (B strain)|-2.49|||||2-Sided|97.4|-7.01|2.0|||||||
1672545|NCT01346592|3077668|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was > -10%|Group difference (H3N2 strain)|-2.84|||||2-Sided|97.4|-6.16|0.5|||||||
1672546|NCT01346592|3077668|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group differences was > -10%|Group difference (H1N1 strain)|-5.3|||||2-Sided|97.4|-10.13|-0.47|||||||
1672547|NCT01346592|3077669|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was >0.667|GMT ratio (B strain)|0.94|||||2-Sided|97.4|0.8|1.11|||||||
1672548|NCT01346592|3077669|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was >0.667|GMT ratio (H3N2 strain)|0.77|||||2-Sided|97.4|0.68|0.86|||||||
1672549|NCT01346592|3077669|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the confidence interval for day 50 GMT group ratios was >0.667|Group ratio (H1N1 strain)|0.76|||||2-Sided|97.4|0.62|0.93|||||||
1672550|NCT01346592|3077670|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was > -10%|Group difference (B strain)|11.1|||||2-Sided|97.6|8.11|14.1|||||||
1672551|NCT01346592|3077670|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was > -10%|Group difference (H3N2 strain)|7.31|||||2-Sided|97.6|4.47|10.14|||||||
1672552|NCT01346592|3077670|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was > -10%|Group difference (H1N1 strain)|14.21|||||2-Sided|97.6|10.3|18.13|||||||
1672553|NCT01346592|3077670|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was > -10%|Group difference (B strain)|11.82|||||2-Sided|97.6|8.72|14.92|||||||
1672554|NCT01346592|3077670|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was >-10%|Group difference (H3N2 strain)|4.07|||||2-Sided|97.6|1.58|6.55|||||||
1672555|NCT01346592|3077670|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the confidence interval for day 50 vaccine group difference was >-10%.|Group difference (H1N1 strain)|9.09|||||2-Sided|97.6|5.48|12.69|||||||
1672556|NCT01346592|3077671|Non-Inferiority or Equivalence|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was >0.667|GMT ratio (B strain)|3.14|||||2-Sided|97.6|2.72|3.62|||||||
1672557|NCT01346592|3077671|Non-Inferiority or Equivalence|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was >0.667|GMT ratio (H3N2 strain)|2.38|||||2-Sided|97.6|2.14|2.65|||||||
1672558|NCT01346592|3077671|Non-Inferiority or Equivalence|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was >0.667|GMT ratio (H1N1 strain)|3.2|||||2-Sided|97.6|2.7|3.8|||||||
1672559|NCT01346592|3077671|Non-Inferiority or Equivalence|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was >0.667|GMT ratio (B strain)|3.07|||||2-Sided|97.6|2.66|3.54|||||||
1672560|NCT01346592|3077671|Non-Inferiority or Equivalence|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was >0.667|GMT ratio (H3N2 strain)|1.89|||||2-Sided|97.6|1.69|2.1|||||||
1672561|NCT01346592|3077671|Non-Inferiority or Equivalence|Noninferiority was established if the lower limit of the confidence interval of the day 50 ratio of GMTs was >0.667|GMT ratio (H1N1 strain)|2.44|||||2-Sided|97.6|2.06|2.9|||||||
1672562|NCT01346488|3077689|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment|
1672563|NCT01346488|3077689|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy|
1672564|NCT01346488|3077689|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48|
1672565|NCT01346488|3077689|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36|
1672566|NCT01346488|3077689|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24|
1672567|NCT01346488|3077689|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12|
1672568|NCT01346488|3077690|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)|
1672569|NCT01346488|3077690|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)|
1672570|NCT01346488|3077690|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)|
1672571|NCT01346488|3077690|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)|
1672572|NCT01346488|3077690|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)|
1672573|NCT01346488|3077690|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)|
1672574|NCT01346488|3077691|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment|
1672578|NCT01346488|3077691|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24|
1672579|NCT01346488|3077691|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12|
1672580|NCT01346488|3077692|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)|
1672581|NCT01346488|3077692|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)|
1672582|NCT01346488|3077692|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)|
1672583|NCT01346488|3077692|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)|
1672584|NCT01346488|3077692|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)|
1672585|NCT01346488|3077692|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)|
1672586|NCT01346488|3077693|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment|
1672587|NCT01346488|3077693|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy|
1672588|NCT01346488|3077693|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48|
1672589|NCT01346488|3077693|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36|
1672590|NCT01346488|3077693|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24|
1672591|NCT01346488|3077693|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12|
1672592|NCT01346488|3077694|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)|
1672593|NCT01346488|3077694|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)|
1672594|NCT01346488|3077694|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)|
1672595|NCT01346488|3077694|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)|
1672596|NCT01346488|3077694|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)|
1672597|NCT01346488|3077694|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)|
1672598|NCT01346488|3077695|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment|
1672599|NCT01346488|3077695|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy|
1672600|NCT01346488|3077695|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48|
1672601|NCT01346488|3077695|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36|
1672602|NCT01346488|3077695|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24|
1672603|NCT01346488|3077695|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12|
1672604|NCT01346488|3077696|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||at final assessment (Remission)|
1672605|NCT01346488|3077696|Superiority or Other||||||=|0||||||P-value adjusted for multiplicity|McNemar|||at discontinuation of ADA therapy (Remission)|
1672606|NCT01346488|3077696|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 48 (Remission)|
1672607|NCT01346488|3077696|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 36 (Remission)|
1672608|NCT01346488|3077696|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 24 (Remission)|
1672609|NCT01346488|3077696|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|McNemar|||Week 12 (Remission)|
1672610|NCT01346488|3077697|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment|
1672611|NCT01346488|3077697|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy|
1672612|NCT01346488|3077697|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48|
1672613|NCT01346488|3077697|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36|
1672614|NCT01346488|3077697|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24|
1672615|NCT01346488|3077697|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12|
1672616|NCT01346488|3077698|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment|
1672617|NCT01346488|3077698|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy|
1672618|NCT01346488|3077698|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48|
1672619|NCT01346488|3077698|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36|
1672620|NCT01346488|3077698|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24|
1672621|NCT01346488|3077698|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12|
1672622|NCT01346488|3077699|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment|
1672623|NCT01346488|3077699|Superiority or Other||||||<|0.0592||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy|
1672624|NCT01346488|3077699|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48|
1672625|NCT01346488|3077699|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36|
1672626|NCT01346488|3077699|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24|
1672627|NCT01346488|3077699|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12|
1672628|NCT01346488|3077700|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment|
1672629|NCT01346488|3077700|Superiority or Other||||||<|0.0054||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy|
1672630|NCT01346488|3077700|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48|
1672631|NCT01346488|3077700|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36|
1672632|NCT01346488|3077700|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24|
1672633|NCT01346488|3077700|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12|
1672634|NCT01346488|3077701|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||at final assessment|
1672635|NCT01346488|3077701|Superiority or Other||||||<|1||||||P-value adjusted for multiplicity|Paired t-test|||at discontinuation of ADA therapy|
1672636|NCT01346488|3077701|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 48|
1672637|NCT01346488|3077701|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 36|
1672638|NCT01346488|3077701|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 24|
1672639|NCT01346488|3077701|Superiority or Other||||||<|0.0001||||||P-value adjusted for multiplicity|Paired t-test|||Week 12|
1672640|NCT01346475|3077705|Superiority or Other||Incident Risk Ratio|0.54|||<|0.001|2-Sided|95.0|0.44|0.66|||Incident risk ratio|The model is adjusted for period effects.||This study had 80% power to detect a 50% reduction in HSV genital shedding rates for high-dose valacyclovir compared to standard dose valacyclovir.|
1672641|NCT01346293|3077720|Non-Inferiority or Equivalence|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL® ) in post-vaccination GMCs for the Fimbriae types 2 and 3 antigens between groups were > 2/3.|Mean Difference (Final Values)|1.33|||||2-Sided|95.0|1.12|1.6||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.|
1672642|NCT01346293|3077720|Non-Inferiority or Equivalence|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertactin antigens between groups were > 2/3.|Mean Difference (Final Values)|1.51|||||2-Sided|95.0|1.27|1.79||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.|
1672643|NCT01346293|3077720|Non-Inferiority or Equivalence|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Filamentous Haemagglutinin antigens between groups were > 2/3.|Mean Difference (Final Values)|1.56|||||2-Sided|95.0|1.3|1.88||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals.|
1672644|NCT01346293|3077720|Non-Inferiority or Equivalence|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertussis Toxoid antigens between groups were > 2/3.|Mean Difference (Final Values)|1.97|||||2-Sided|95.0|1.68|2.31||||||Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each Pertussis antigen and their 2-sided 95% Confidence Intervals.|
1672645|NCT01346293|3077721|Non-Inferiority or Equivalence|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Fimbriae types 2 and 3 antigens between groups were > -10%.|Mean Difference (Final Values)|4.8|||||2-Sided|95.0|0.9|9.1||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.|
1672646|NCT01346293|3077721|Non-Inferiority or Equivalence|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for the Pertactin antigens between groups were > -10%.|Mean Difference (Final Values)|3.7|||||2-Sided|3.7|-0.2|7.9||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.|
1672647|NCT01346293|3077721|Non-Inferiority or Equivalence|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Filamentous Haemagglutinin between groups were > -10%.|Mean Difference (Final Values)|7.4|||||2-Sided|95.0|2.5|21.5||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.|
1672648|NCT01346293|3077721|Non-Inferiority or Equivalence|Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% Confidence intervals (CIs) of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Pertussis toxoid antigen between groups were > -10%.|Mean Difference (Final Values)|5.4|||||2-Sided|95.0|0.7|10.2||||||Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters.|
1672649|NCT01346072|3077733|Superiority|||||||0.035|||||||Wilcoxon Two-Sample Test|Wilcoxon Two Sample Test was used with Exact Test two sided p value reported|||
1672650|NCT01346072|3077734|Superiority|||||||0.853|||||||Wilcoxon Two-Sample Test|Wilcoxon Two Sample Test was used with Exact Test two sided p value reported|||
1672651|NCT01345929|3077738|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.|Risk Difference (RD)|8.0|||||2-Sided|95.0|1.95|13.97|||||||
1672652|NCT01345929|3077739|Non-Inferiority or Equivalence|Noninferiority was concluded if the lower bound of the 2-sided 95% CI was greater than -10%.|Risk Difference (RD)|8.5|||||2-Sided|95.0|2.31|14.57|||||||
1672653|NCT01345786|3077746|Non-Inferiority or Equivalence|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|101.3||||||90.0|98.1|104.7|||||"Commercial Batch Test / Phase 3 Batch Reference.~In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison."||
1672654|NCT01345786|3077746|Non-Inferiority or Equivalence|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|101.5||||||90.0|96.7|106.4|||||Commercial Batch Test / Phase 3 Batch Reference.||
1672655|NCT01345786|3077747|Non-Inferiority or Equivalence|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.1||||||90.0|100.5|105.8|||||Commercial Batch Test / Phase 3 Batch Reference|Analysis for AUC infinity|
1672656|NCT01345786|3077747|Non-Inferiority or Equivalence|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|108.1||||||90.0|104.7|111.6|||||Commercial Batch Test / Phase 3 Batch Reference.|Analysis for AUC infinity|
1672657|NCT01345786|3077747|Non-Inferiority or Equivalence|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.3||||||90.0|100.9|105.7|||||Commercial Batch Test / Phase 3 Batch Reference|Analysis for AUC last|
1672658|NCT01345786|3077747|Non-Inferiority or Equivalence|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|110.0||||||90.0|106.4|113.7|||||Commercial Batch Test / Phase 3 Batch Reference.|Analysis for AUClast|
1672659|NCT01345786|3077748|Non-Inferiority or Equivalence|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|103.6||||||90.0|99.2|108.2|||||"Commercial Batch Test / Phase 3 Batch Reference.~In addition to the participants/profiles excluded, 1 participant from the Phase 3 Batch Reference group did not contribute to this comparison."||
1672660|NCT01345786|3077748|Non-Inferiority or Equivalence|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|107.3||||||90.0|99.0|116.4|||||Commercial Batch Test / Phase 3 Batch Reference.||
1672661|NCT01345786|3077749|Non-Inferiority or Equivalence|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|111.8||||||90.0|107.5|116.4|||||Commercial Batch Test / Phase 3 Batch Reference.||
1672662|NCT01345786|3077749|Non-Inferiority or Equivalence|Acceptance criteria of 80 - 125% were used for bioequivalence evaluations (bioequivalence concluded when 90% confidence interval fully contained within acceptance criteria).|Ratio (Test/Ref %)|137.5||||||90.0|131.0|144.4|||||Commercial Batch Test / Phase 3 Batch Reference.||
1672663|NCT01345682|3077760|Superiority or Other||Hazard Ratio (HR)|0.74||||0.0268|2-Sided|95.0|0.56|0.97||Log−rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"||
1672664|NCT01345682|3077761|Superiority or Other||Hazard Ratio (HR)|0.67||||0.004|2-Sided|95.0|0.5|0.89||Log−rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"||
1672665|NCT01345682|3077762|Superiority or Other||Hazard Ratio (HR)|0.73||||0.0217|2-Sided|95.0|0.55|0.96||Log−rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No).||
1672666|NCT01345682|3077763|Superiority or Other||Odds Ratio (OR)|1.06||||0.816|2-Sided|95.0|0.657|1.705|||Regression, Logistic||Odds ratio, 95% CI and p−value (two−sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate||
1672667|NCT01345682|3077764|Superiority or Other||Odds Ratio (OR)|1.16||||0.584|2-Sided|95.0|0.687|1.95|||Regression, Logistic||Odds ratio, 95% CI and p−value (two−sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate||
1672668|NCT01345682|3077765|Superiority or Other||Odds Ratio (OR)|1.19||||0.494|2-Sided|95.0|0.717|1.99|||Regression, Logistic||Odds ratio, 95% CI and p−value (two−sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No). Afatinib (BIBW 2992) vs Methotrexate||
1672669|NCT01345682|3077766|Superiority or Other||Adjusted mean difference|0.6|Standard Error of the Mean|1.95||0.7767|2-Sided|95.0|-3.28|4.39||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR−targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG PS and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).|
1672685|NCT01345669|3077777|Superiority or Other||Hazard Ratio (HR)|1.444||||0.1301|2-Sided|95.0|0.895|2.332||p−value (two−sided) from log−rank test stratified by baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3).|Log Rank|||Hazard ratio from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3).|
1672916|NCT01342458|3078136|Superiority or Other||Effect size|1.07|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 3rd month.|
1672670|NCT01345682|3077767|Superiority or Other||Adjusted mean difference|-0.1|Standard Error of the Mean|2.16||0.9773|2-Sided|95.0|-4.3|4.18||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR−targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG PS and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).|
1672671|NCT01345682|3077768|Superiority or Other||Adjusted mean difference|-4.4|Standard Error of the Mean|2.01||0.03|2-Sided|95.0|-8.31|-0.42||Adjusted for baseline ECOG performance score (0 or 1) and prior use of EGFR−targeted antibody for R/M HNSCC (Yes or No).|longitudinal models||Afatinib (BIBW 2992) vs Methotrexate|Changes in scores over time were assessed using longitudinal models, i.e. mixed effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score (PS) and prior use of EGFR-targeted antibody for recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC).|
1672672|NCT01345682|3077770|Superiority or Other||Odds Ratio (OR)|1.52||||0.0353|2-Sided|95.0|1.03|2.26|||Regression, Logistic||"Odds ratio, 95% CI and p−value (two−sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"||
1672673|NCT01345682|3077771|Superiority or Other||Odds Ratio (OR)|1.91||||0.101|2-Sided|95.0|0.88|4.14|||Regression, Logistic||"Odds ratio, 95% Confidence Interval (CI) and p−value (two−sided) from logistic regression stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"||
1672674|NCT01345682|3077772|Superiority or Other||Hazard Ratio (HR)|0.958||||0.6755|2-Sided|95.0|0.786|1.169||Log−rank test stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"||
1672675|NCT01345682|3077773|Superiority or Other||Hazard Ratio (HR)|0.792||||0.0257|2-Sided|95.0|0.643|0.977||Log−rank test stratified by baseline Eastern Cooperative Oncology Group (ECOG) Performance score (PS)(0 or 1) and prior use of Epidermal Growth Factor Receptor (EGFR)−targeted antibody in the Recurrent and/or Metastatic (R/M) setting (Yes or No).|Stratified Log-rank test||"Hazard ratio from Cox proportional hazards model stratified by baseline ECOG PS (0 or 1) and prior use of EGFR−targeted antibody in the R/M setting (Yes or No).~Afatinib (BIBW 2992) vs Methotrexate"||
1672676|NCT01345669|3077774|Superiority or Other||Mean Difference (Final Values)|-3.4|Standard Error of the Mean|0.98||0.0005|2-Sided|95.0|-5.33|-1.49|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3).|Scores (global health/QoL) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.|
1672677|NCT01345669|3077774|Superiority or Other||Mean Difference (Final Values)|3.2|Standard Error of the Mean|1.08||0.0028|2-Sided|95.0|1.12|5.36|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3).|Scores (pain scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.|
1672678|NCT01345669|3077774|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|1.08||0.2232|2-Sided|95.0|-0.81|3.45|||Mixed Models Analysis|Degrees of freedom calculated using the Kenward-Roger method.|Afatinib minus Placebo mean adjusted for total with data for baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3).|Scores (swallowing scale) over time were assessed using longitudinal mixed-effects growth curve models with the average profile over time for each endpoint described by a piecewise linear model adjusted for the fixed effects baseline ECOG performance score and nodal status.|
1672679|NCT01345669|3077775|Superiority or Other||Hazard Ratio (HR)|1.604||||0.0002|2-Sided|95.0|1.238|2.079||P−value from log−rank test stratified by baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3).|Log Rank|||For global health status/QoL scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3).|
1672680|NCT01345669|3077775|Superiority or Other||Hazard Ratio (HR)|1.456||||0.0049|2-Sided|95.0|1.113|1.905||P−value from log−rank test stratified by baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3).|Log Rank|||For pain HN35 scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3).|
1672681|NCT01345669|3077775|Superiority or Other||Hazard Ratio (HR)|1.295||||0.0591|2-Sided|95.0|0.986|1.7||P−value from log−rank test stratified by baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3).|Log Rank|||For swallowing scale; Hazard ratio from Cox proportional hazard model stratified by baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3).|
1672682|NCT01345669|3077776|Superiority or Other||Odds Ratio (OR)|0.818||||0.257|2-Sided|95.0|0.577|1.158|||Regression, Logistic|||Odds ratio and p−value from logistic regression analysis of ’improved vs. not improved’ stratified by baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3) for Global health status/QoL(Q29−Q30 from QLQ−C30).|
1672683|NCT01345669|3077776|Superiority or Other||Odds Ratio (OR)|1.446||||0.0523|2-Sided|95.0|0.996|2.098|||Regression, Logistic|||Odds ratio and p−value from logistic regression analysis of ’improved vs. not improved’ stratified by baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3) for Pain HN35 (Q1−Q4 from QLQ−HN35).|
1672684|NCT01345669|3077776|Superiority or Other||Odds Ratio (OR)|1.431||||0.0561|2-Sided|95.0|0.991|2.068|||Regression, Logistic|||Odds ratio and p−value from logistic regression analysis of ’improved vs. not improved’ stratified by baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3) for Swallowing (Q5−Q8 from QLQ−HN35).|
1673224|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.57||||0.19|2-Sided|95.0|0.8|3.07|||Regression, Logistic||||
1672686|NCT01345669|3077778|Superiority or Other||Difference in Kaplan-Meier estimates|-6.27||||0.161|2-Sided|95.0|-15.04|2.5|||Log Rank||Difference in Kaplan-Meier estimates of Afatinib vs. Placebo is provided.|Kaplan-Meier (KM) curves were calculated for each treatment group, separately, and the estimates of DFS probabilities from the curves and 95% Confidence interval (CI) (using the Greenwood standard error estimate) were tabulated|
1672687|NCT01345669|3077779|Superiority or Other||Hazard Ratio (HR)|1.126||||0.4806|2-Sided|95.0|0.809|1.569|||Log Rank||Hazard ratio (Afatinib vs. Placebo) from Cox proportional hazards model stratified by baseline ECOG (0 or 1) and nodal status (N0−N2a or N2b−N3).|DFS was analysed using a stratified log-rank test with nodal status (N0- N2a vs. N2b-N3) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1) being the stratification factors.|
1672688|NCT01345630|3077780|Superiority or Other||Mean Difference (Final Values)|-126.78||||0.0071|2-Sided|95.0|-218.34|-35.23|||ANCOVA|||Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.|
1672689|NCT01345630|3077781|Superiority or Other||Mean Difference (Final Values)|-2.12||||0.1722|2-Sided|95.0|-5.17|0.94|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.|
1672690|NCT01345630|3077782|Superiority or Other||Mean Difference (Final Values)|0.005||||0.4188|2-Sided|95.0|-0.007|0.018|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.|
1672691|NCT01345630|3077783|Superiority or Other||Mean Difference (Final Values)|0.008||||0.2273|2-Sided|95.0|-0.005|0.022|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.|
1672692|NCT01345630|3077784|Superiority or Other||Mean Difference (Final Values)|0.014||||0.0043|2-Sided|95.0|0.004|0.023|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.|
1672693|NCT01345630|3077785|Superiority or Other||Mean Difference (Final Values)|0.031||||0.3376|2-Sided|95.0|-0.033|0.094|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.|
1672694|NCT01345630|3077786|Superiority or Other||Mean Difference (Final Values)|75.861||||0.8379|2-Sided|95.0|-658.181|809.903|||ANCOVA|||Results are from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: treatment group, age, race, Screening BMI, and Baseline value of the response variable. Treatment differences are estimated using LS means with factor levels weighted according to overall analysis population proportions.|
1672695|NCT01345630|3077787|Superiority or Other||Mean Difference (Final Values)|-0.11|||<|0.0001|2-Sided|95.0|-0.15|-0.07|||ANCOVA|||Results are from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.|
1672696|NCT01345630|3077788|Superiority or Other||Mean Difference (Final Values)|2.1|||<|0.0001|2-Sided|95.0|1.1|3.1|||ANCOVA|||Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.|
1672697|NCT01345630|3077789|Superiority or Other||Mean Difference (Final Values)|127.7|||<|0.0001|2-Sided|95.0|76.5|178.8|||ANCOVA|||Results were from ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.|
1672698|NCT01345630|3077790|Superiority or Other||Mean Difference (Final Values)|-2.3|||<|0.0001|2-Sided|95.0|-3.1|-1.5|||ANCOVA|||Results were from ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.|
1672699|NCT01345630|3077791|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.975|2-Sided|95.0|-24.4|23.6|||ANCOVA|||Results were from an ANCOVA model with change from Baseline as the response variable and the following fixed effect model terms: Treatment group, Screening plasma HIV RNA concentration, Screening Tropism Assay, Baseline value of the response variable.|
1672700|NCT01345630|3077796|Superiority or Other||Treatment difference|-0.075|Standard Error of the Mean|0.0303|||2-Sided|95.0|-0.1343|-0.0157||||||The difference in proportions of patients with plasma HIV-1 RNA <50 copies/mL at Week 48 between the [MVC+DRV/r] and the [FTC/TDF+DRV/r] treatment arms, with two-sided 95% confidence interval, is shown for those patients who were R5 by genotype (including all who were originally randomized to ESTA and were R5 by genotype upon retesting), via the maximum likelihood (ML) method.|
1672701|NCT01345630|3077804|Non-Inferiority or Equivalence|For the analysis of the primary endpoint conducted at Week 48, the alternative hypothesis was to test for non-inferiority of MVC+DRV/r to FTC/TDF+DRV/r with a non-inferiority margin of -10%.|Mean Difference (Final Values)|-9.54|||||2-Sided|95.0|-14.83|-4.24||||||The difference in the percentages between the maraviroc and the emtricitabine/tenofovir treatment arms and the 2-sided 95% confidence interval for the difference was provided using the stratum-adjusted Mantel-Haenszel (MH) method over the two assays and the screening plasma HIV-1 RNA levels (>=100,000 copies/mL or <100,000 copies/mL). The sample size was chosen to yield a power of ≥90%. The 95% CIs and mean difference (final values) are presented as percentages above.|
1672702|NCT01345292|3077813|Superiority or Other||Mean Difference (Final Values)|-6.13|Standard Error of the Mean|2.344||0.01|2-Sided|95.0|-10.8|-1.51||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672703|NCT01345292|3077813|Superiority or Other||Mean Difference (Final Values)|-8.53|Standard Error of the Mean|2.331|<|0.001|2-Sided|95.0|-13.1|-3.94||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672704|NCT01345292|3077814|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|2.023||0.522|2-Sided|95.0|-5.29|2.69||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672705|NCT01345292|3077814|Superiority or Other||Mean Difference (Final Values)|-1.26|Standard Error of the Mean|2.012||0.533|2-Sided|95.0|-5.22|2.71||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672706|NCT01345292|3077815|Superiority or Other||Mean Difference (Final Values)|-10.2|Standard Error of the Mean|2.527|<|0.001|2-Sided|95.0|-15.2|-5.25||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672707|NCT01345292|3077815|Superiority or Other||Mean Difference (Final Values)|-11.2|Standard Error of the Mean|2.508|<|0.001|2-Sided|95.0|-16.1|-6.23||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672708|NCT01345292|3077816|Superiority or Other||Mean Difference (Final Values)|-3.42|Standard Error of the Mean|2.288||0.136|2-Sided|95.0|-7.93|1.09||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672709|NCT01345292|3077816|Superiority or Other||Mean Difference (Final Values)|-4.91|Standard Error of the Mean|2.271||0.032|2-Sided|95.0|-9.38|-0.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air stimulus VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672710|NCT01345292|3077817|Superiority or Other||Mean Difference (Final Values)|-10.2|Standard Error of the Mean|2.553|<|0.001|2-Sided|95.0|-15.2|-5.13||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672711|NCT01345292|3077817|Superiority or Other||Mean Difference (Final Values)|-8.55|Standard Error of the Mean|2.551|<|0.001|2-Sided|95.0|-13.6|-3.52||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672712|NCT01345292|3077818|Superiority or Other||Mean Difference (Final Values)|-4.43|Standard Error of the Mean|2.093||0.035|2-Sided|95.0|-8.56|-0.31||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672713|NCT01345292|3077818|Superiority or Other||Mean Difference (Final Values)|-2.06|Standard Error of the Mean|2.091||0.324|2-Sided|95.0|-6.19|2.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672714|NCT01345292|3077819|Superiority or Other||Mean Difference (Final Values)|2.41|Standard Error of the Mean|0.818||0.004|2-Sided|95.0|0.8|4.02||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672715|NCT01345292|3077819|Superiority or Other||Mean Difference (Final Values)|3.05|Standard Error of the Mean|0.812|<|0.001|2-Sided|95.0|1.45|4.65||The significance threshold level was 0.05 (two-sided). Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672779|NCT01344460|3077925|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|13.4|||||2-Sided|95.0|11.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1673225|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.39||||0.34|2-Sided|95.0|0.71|2.71|||Regression, Logistic||||
1672716|NCT01345292|3077820|Superiority or Other||Mean Difference (Final Values)|8.33|Standard Error of the Mean|1.566|<|0.001|2-Sided|95.0|5.24|11.42||If Potassium Oxalate Mouth Rinse is better than Crest Regular (p<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Potassium Oxalate Mouth Rinse and Crest Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672717|NCT01345292|3077820|Superiority or Other||Mean Difference (Final Values)|11.44|Standard Error of the Mean|1.556|<|0.001|2-Sided|95.0|8.37|14.5||If Sensodyne is better than Crest Regular (p<0.05), testing would proceed to comparison of Wk 2 Mean Tactile Sensitivity Scores between Sensodyne and Crest Regular. Family-wise error was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1672718|NCT01345253|3077822|Superiority or Other (legacy)||Hazard Ratio (HR)|0.5||||0.0004|2-Sided|95.0|0.34|0.73|||Regression, Cox||||
1672719|NCT01345253|3077823|Superiority or Other (legacy)|||||||0.0288|||||||Rank ANCOVA||||
1672720|NCT01345253|3077824|Superiority or Other (legacy)||Odds Ratio (OR)|1.76||||0.0116|2-Sided|95.0|1.13|2.74|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).||
1672721|NCT01345253|3077825|Superiority or Other (legacy)||Odds Ratio (OR)|2.0||||0.0001|2-Sided|95.0|1.41|2.83|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).||
1672722|NCT01345253|3077826|Superiority or Other (legacy)||Odds Ratio (OR)|1.99||||0.0001|2-Sided|95.0|1.4|2.82|||Regression, Logistic||Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement (C) levels (low C3 and/or C4 vs. no low C3 or C4).||
1672723|NCT01345240|3077837|Non-Inferiority|Criteria for non-inferiority: one month post Dose 2, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the geometric mean concentrations (GMC) ratios of rotavirus antibodies (IgA) concentrations is below 2 for the rotavirus vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.11|||||2-Sided|95.0|0.76|1.61||||||To demonstrate the non-inferiority of antibody response to the rotavirus vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen|
1672724|NCT01345240|3077838|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.1|||||2-Sided|95.0|0.98|1.22||||||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertactin (anti-PRN), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.|
1672725|NCT01345240|3077838|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.08|||||2-Sided|95.0|0.97|1.21||||||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, filamentous haemagglutinin (FHA), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.|
1672726|NCT01345240|3077838|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.08|||||2-Sided|95.0|0.97|1.2||||||To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertussis toxoid, (PT) of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.|
1672727|NCT01345240|3077844|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.12|||||2-Sided|95.0|0.81|1.55||||||To demonstrate the non-inferiority of antibody against 23F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.|
1672728|NCT01345240|3077844|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.21|||||2-Sided|95.0|0.89|1.65||||||To demonstrate the non-inferiority of antibody against serotype 19F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.|
1672729|NCT01345240|3077844|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.81|||||2-Sided|95.0|1.38|2.38||||||To demonstrate the non-inferiority of antibody against 18C responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.|
1672730|NCT01345240|3077844|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|0.99|||||2-Sided|95.0|0.77|1.27||||||To demonstrate the non-inferiority of antibody against serotype 14 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.|
1672808|NCT01344447|3077944|Superiority or Other||percentage|59.6|||||1-Sided|95.1|53.1|||||||Blinded Reader 2|
1672731|NCT01345240|3077844|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.32|||||2-Sided|95.0|1.08|1.63||||||To demonstrate the non-inferiority of antibody against serotype 9V responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.|
1672732|NCT01345240|3077844|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.12|||||2-Sided|95.0|0.94|1.33||||||To demonstrate the non-inferiority of antibody against serotype 7F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.|
1672733|NCT01345240|3077844|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.17|||||2-Sided|95.0|0.83|1.65||||||To demonstrate the non-inferiority of antibody against serotype 6B responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.|
1672734|NCT01345240|3077844|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.27|||||2-Sided|95.0|1.06|1.52||||||To demonstrate the non-inferiority of antibody against serotype 5 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.|
1672735|NCT01345240|3077844|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.2|||||2-Sided|95.0|0.97|1.48||||||To demonstrate the non-inferiority of antibody against serotype 4 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.|
1672736|NCT01345240|3077844|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.|GMC ratio|1.15|||||2-Sided|95.0|0.95|1.39||||||To demonstrate the non-inferiority of antibody against serotype 1 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.|
1672737|NCT01345240|3077852|Equivalence|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within [0.5, 2].|GMC ratio|1.1|||||2-Sided|95.0|0.84|1.45||||||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.|
1672738|NCT01345240|3077852|Equivalence|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within [0.5, 2].|GMC ratio|1.0|||||2-Sided|95.0|0.76|1.32||||||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.|
1672739|NCT01345240|3077852|Equivalence|Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within [0.5, 2].|GMC ratio|0.91|||||2-Sided|95.0|0.69|1.2||||||To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.|
1672740|NCT01345240|3077855|Non-Inferiority|Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the difference in percent seroprotection below 5% between recipients of licensed hepatitis B vaccine (Engerix-B) and recipients of RTS,S/AS01E vaccine.|Difference in percent seroprotection|-3.95|||||2-Sided|95.0|-7.12|-2.16||||||Non-inferiority of the immune response to the hepatitis B antigen induced by RTS,S/AS01E vaccine versus a licensed hepatitis B vaccine.|
1672741|NCT01345188|3077856|Superiority or Other (legacy)||||||>|0.05|||||||Wilcoxon Signed rank||||
1672742|NCT01345188|3077857|Superiority or Other (legacy)|||||||0.048|||||||Paired t test||||
1672743|NCT01345188|3077858|Superiority or Other (legacy)|||||||0.058|||||||Paired t test||||
1672744|NCT01345123|3077864|Superiority or Other||Mean Difference (Net)|-0.0183548|Standard Error of the Mean|0.04690321||0.6956|2-Sided|95.0|-0.1102961|0.07358642|||ANCOVA||||
1672745|NCT01345123|3077864|Superiority or Other||Mean Difference (Net)|-0.009122|Standard Error of the Mean|0.0467091||0.8454|2-Sided|95.0|-0.1008434|0.08259938|||ANCOVA||||
1672746|NCT01345123|3077867|Superiority or Other||Mean Difference (Net)|0.15982||||0.0106|2-Sided|95.0|-0.06477|0.38441|||ANOVA||||
1672747|NCT01345123|3077867|Superiority or Other||Mean Difference (Net)|0.31257||||0.0106|2-Sided|95.0|0.06895|0.55618|||ANOVA||||
1672748|NCT01345123|3077870|Superiority or Other||Odds Ratio (OR)|0.805||||0.0511||95.0|0.647|1.001|||Regression, Logistic|Covariates: Age, Gender, Charlson Comorbidity index, calculated risk of knee replacement, hip replacement, herniated disc surgery (score 1-99)|||
1672749|NCT01345123|3077871|Superiority or Other||Mean Difference (Net)|-0.013717|Standard Error of the Mean|0.04018791||0.7329|2-Sided|95.0|-0.0924947|0.06506063|||ANCOVA||||
1672750|NCT01345123|3077871|Superiority or Other||Mean Difference (Net)|0.0019994|Standard Error of the Mean|0.0400918||0.9602|2-Sided|95.0|-0.0765899|0.080588716|||ANCOVA|Covariates: age, gender, Charlson Comorbidity Index, prior year total medical costs pmpm|||
1672751|NCT01345058|3077876|Superiority||Hazard Ratio (HR)|0.76||||0.49|2-Sided|95.0|0.35|1.65|||Chi-squared||Hazard ratio for seizure occurrence for polytherapy relative to monotherapy.||
1672809|NCT01344447|3077944|Superiority or Other||percentage|60.3|||||1-Sided|95.1|53.6|||||||Blinded Reader 1|
1672752|NCT01345019|3077878|Superiority|If superiority of denosumab over zoledronic acid was established for both time to first SRE and time to first and subsequent SRE, the additional secondary endpoint (overall survival) was to be tested at a significance level of 0.05.|Hazard Ratio (HR)|0.9||||0.41|2-Sided|95.0|0.7|1.16|||Cox proportional hazards model||A hazard ratio (denosumab:zoledronic acid) < 1 favors denosumab.|The survival function of time to death for each treatment group was estimated using Kaplan-Meier method and the hazard ratio of denosumab compared with zoledronic acid and its 2-sided 95% CI were estimated using a Cox proportional hazards model stratified by the randomization stratification factors and including treatment groups, age, race group, geographic region, baseline creatinine clearance, baseline risk per cytogenetic based prognosis, and baseline ECOG as independent variables.|
1672753|NCT01345019|3077880|Superiority|The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE [superiority] and time to first and subsequent on study SRE [superiority, multiple event analysis]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.|Rate ratio|1.01||||0.84|2-Sided|95.0|0.89|1.15|||Andersen-Gill model|Based on an Andersen-Gill model stratified by the randomization stratification factors.|A rate ratio (denosumab:zoledronic acid) < 1 favors denosumab.||
1672754|NCT01345019|3077881|Superiority|The statistical inferences of the treatment effect on secondary efficacy endpoints (time to the first on study SRE [superiority] and time to first and subsequent on study SRE [superiority, multiple event analysis]) were to be conducted if denosumab was determined to be non-inferior to zoledronic acid. To control the overall type I error for multiple comparisons at a significant level of 0.05, these secondary efficacy endpoints were tested simultaneously using the Hochberg procedure.||||||0.82|||||||Log Rank|Based on a log rank test stratified by randomization stratification factors.|||
1672755|NCT01345019|3077884|Non-Inferiority|A two-stage approach was used for the non-inferiority test. First, the fixed margin approach was used to ensure denosumab has an effect greater than placebo (ie, the non-inferiority margin M1, ie, the lower bound of the two-sided 95% confidence interval 1.28, is ruled out). Next, a synthesis method was used for the non-inferiority test of the hypothesis that denosumab preserved at least 50% of the effect of zoledronic acid (HR [95% CI] of 1.48 [1.28, 1.71] for placebo vs zoledronic acid.|Hazard Ratio (HR)|0.98||||0.01|2-Sided|95.0|0.85|1.14|||Cox proportional hazards model|Based on a Cox proportional hazards model stratified by the randomization stratification factors.|A hazard ratio (denosumab:zoledronic acid) < 1 favors denosumab||
1672756|NCT01344629|3077896|Non-Inferiority or Equivalence|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|109.0||||||90.0|101.5|117.1|||||||
1672757|NCT01344629|3077897|Non-Inferiority or Equivalence|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|109.4||||||90.0|102.4|116.8|||||||
1672758|NCT01344629|3077898|Non-Inferiority or Equivalence|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|91.4||||||90.0|85.6|97.6|||||||
1672759|NCT01344629|3077899|Non-Inferiority or Equivalence|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|110.1||||||90.0|95.8|124.4|||||||
1672760|NCT01344629|3077900|Non-Inferiority or Equivalence|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|101.7||||||90.0|98.3|105.2|||||||
1672761|NCT01344629|3077901|Non-Inferiority or Equivalence|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|97.2||||||90.0|87.2|108.3|||||||
1672762|NCT01344629|3077902|Non-Inferiority or Equivalence|Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use|Test/Reference Ratio of the mean x 100|100.9||||||90.0|97.7|104.2|||||||
1672763|NCT01344538|3077905|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1672764|NCT01344460|3077920|Superiority or Other||Diameter difference|-0.15|Standard Deviation|1.01||||||||||||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point|
1672765|NCT01344460|3077920|Superiority or Other||Mean Difference|0.41|Standard Deviation|1.15||||||||||||CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point|
1672766|NCT01344460|3077920|Superiority or Other||Diameter difference|-0.09|Standard Deviation|1.14||||||||||||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point|
1672767|NCT01344460|3077920|Superiority or Other||Diameter difference|0.17|Standard Deviation|1.28||||||||||||CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point|
1672768|NCT01344460|3077923|Superiority or Other||percentage|98.4|||||1-Sided|95.0|97.8|||||||Clinical investigator|
1672769|NCT01344460|3077923|Superiority or Other||percentage|95.8|||||1-Sided|95.0|94.8|||||||Blinded Reader 3|
1672770|NCT01344460|3077923|Superiority or Other||percentage|96.2|||||1-Sided|95.0|95.2|||||||Blinded Reader 2|
1672771|NCT01344460|3077923|Superiority or Other||percentage|95.0|||||1-Sided|95.0|93.8|||||||Blinded Reader 1|
1672772|NCT01344460|3077923|Superiority or Other||percentage|95.9|||||1-Sided|95.0|94.9|||||||Majority reader|
1672773|NCT01344460|3077924|Superiority or Other||percentage|71.3|||||1-Sided|95.0|64.7|||||||Clinical investigator|
1672774|NCT01344460|3077924|Superiority or Other||percentage|53.4|||||1-Sided|95.0|44.8|||||||Blinded Reader 3|
1672775|NCT01344460|3077924|Superiority or Other||percentage|54.4|||||1-Sided|95.0|45.5|||||||Blinded Reader 2|
1672776|NCT01344460|3077924|Superiority or Other||percentage|51.6|||||1-Sided|95.0|43.6|||||||Blinded Reader 1|
1672777|NCT01344460|3077924|Superiority or Other||percentage|54.6|||||1-Sided|95.0|46.2|||||||Majority reader|
1672778|NCT01344460|3077925|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|13.1|||||2-Sided|95.0|11.0||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672810|NCT01344447|3077944|Superiority or Other||percentage|61.7|||||1-Sided|95.1|55.3|||||||Majority reader|
1673226|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.12||||0.74|2-Sided|95.0|0.58|2.15|||Regression, Logistic||||
1672780|NCT01344460|3077925|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|9.7|||||2-Sided|95.0|7.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672781|NCT01344460|3077925|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|11.3|||||2-Sided|95.0|9.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672782|NCT01344460|3077925|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|9.0|||||2-Sided|95.0|7.0||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672783|NCT01344460|3077926|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|20.0|||||2-Sided|95.0|11.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672784|NCT01344460|3077926|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|3.0|||||2-Sided|95.0|-5.8||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672785|NCT01344460|3077926|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|14.3|||||2-Sided|95.0|5.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672786|NCT01344460|3077926|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|0.0|||||2-Sided|95.0|-9.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672787|NCT01344460|3077926|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|6.8|||||2-Sided|95.0|-2.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672788|NCT01344460|3077927|Superiority or Other||Percentage difference|25.6|||<|0|2-Sided|95.0|21.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|||Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672789|NCT01344460|3077927|Superiority or Other||Percentage difference|17.4|||<|0|2-Sided|95.0|14.3||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|||Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672790|NCT01344460|3077927|Superiority or Other||Percentage difference|24.0|||<|0|2-Sided|95.0|20.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672791|NCT01344460|3077927|Superiority or Other||Percentage difference|16.4|||<|0|2-Sided|95.0|13.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672792|NCT01344460|3077927|Superiority or Other||Percentage difference|18.3|||<|0|2-Sided|95.0|15.2||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672793|NCT01344447|3077942|Superiority or Other||Diameter difference|0.11|Standard Deviation|0.79||||||||||||CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at narrowest point|
1672794|NCT01344447|3077942|Superiority or Other||Diameter difference|0.02|Standard Deviation|0.81||||||||||||CTA minus Unenhanced MRA for clinical investigators on vessel DIA at narrowest point|
1672795|NCT01344447|3077942|Superiority or Other||Diameter difference|0.33|Standard Deviation|1.01||||||||||||CTA minus Gadobutrol-enhanced MRA for clinical investigators on vessel DIA at normal point|
1672796|NCT01344447|3077942|Superiority or Other||Diameter difference|0.48|Standard Deviation|0.98||||||||||||CTA minus Unenhanced MRA for clinical investigators on vessel DIA at normal point|
1672797|NCT01344447|3077942|Superiority or Other||Diameter difference|0.01|Standard Deviation|0.8||||||||||||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at narrowest point|
1672798|NCT01344447|3077942|Superiority or Other||Diameter difference|0.29|Standard Deviation|0.87||||||||||||CTA minus Unenhanced MRA for blinded reader on vessel DIA at narrowest point|
1672799|NCT01344447|3077942|Superiority or Other||Diameter difference|0.0|Standard Deviation|0.79||||||||||||CTA minus Gadobutrol-Enhanced MRA for blinded reader on vessel DIA at normal point|
1672800|NCT01344447|3077942|Superiority or Other||Diameter difference|0.21|Standard Deviation|0.8||||||||||||CTA Minus Unenhanced MRA for blinded Reader on vessel DIA at normal point|
1672801|NCT01344447|3077943|Superiority or Other||percentage|99.2|||||1-Sided|95.1|98.9|||||||Clinical investigator|
1672802|NCT01344447|3077943|Superiority or Other||percentage|98.0|||||1-Sided|95.1|97.7|||||||Blinded Reader 3|
1672803|NCT01344447|3077943|Superiority or Other||percentage|97.2|||||1-Sided|95.1|96.9|||||||Blinded Reader 2|
1672804|NCT01344447|3077943|Superiority or Other||percentage|97.6|||||1-Sided|95.1|97.3|||||||Blinded Reader 1|
1672805|NCT01344447|3077943|Superiority or Other||percentage|98.0|||||1-Sided|95.1|97.7|||||||Majority reader|
1672806|NCT01344447|3077944|Superiority or Other||percentage|61.5|||||1-Sided|95.1|56.7|||||||Clinical investigator|
1672807|NCT01344447|3077944|Superiority or Other||percentage|58.7|||||1-Sided|95.1|52.2|||||||Blinded Reader 3|
1672811|NCT01344447|3077945|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|9.1|||||2-Sided|95.1|7.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672812|NCT01344447|3077945|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|7.6|||||2-Sided|95.1|6.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672813|NCT01344447|3077945|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|9.7|||||2-Sided|95.1|8.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672814|NCT01344447|3077945|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|30.3|||||2-Sided|95.1|28.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672815|NCT01344447|3077945|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|8.8|||||2-Sided|95.1|7.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672816|NCT01344447|3077946|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|21.5|||||2-Sided|95.1|14.1||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Clinical investigator; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672817|NCT01344447|3077946|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|3.2|||||2-Sided|95.1|-5.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Blinded reader 3; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672818|NCT01344447|3077946|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|5.1|||||2-Sided|95.1|-4.7||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Blinded reader 2; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672819|NCT01344447|3077946|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|5.1|||||2-Sided|95.1|-5.4||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Blinded reader 1; the percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672820|NCT01344447|3077946|Non-Inferiority or Equivalence|using a -7.5% non-inferiority margin|Percentage difference|5.7|||||2-Sided|95.1|-3.6||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.|||||Majority reader; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672821|NCT01344447|3077947|Superiority or Other||Percentage difference|18.5|||<|0.0001|2-Sided|95.1|16.5||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Clinical investigator; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672822|NCT01344447|3077947|Superiority or Other||Percentage difference|15.0|||<|0.0001|2-Sided|95.1|13.3||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 3; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672823|NCT01344447|3077947|Superiority or Other||Percentage difference|19.6|||<|0.0001|2-Sided|95.1|17.8||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 2; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672824|NCT01344447|3077947|Superiority or Other||Percentage difference|63.8|||<|0.0001|2-Sided|95.1|60.9||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Blinded reader 1; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672825|NCT01344447|3077947|Superiority or Other||Percentage difference|22.3|||<|0.0001|2-Sided|95.1|20.4||Not Appropriate, upper intervals were not used in the statistical analysis and were not of interest for the study.||McNemar|Cluster adjusted McNemar||Majority reader; Superiority analysis; The percentage difference was calculated as gadobutrol-enhanced minus unenhanced MRA.|
1672826|NCT01344369|3077948|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.44|||||2-Sided|90.0|92.22|100.84|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1672827|NCT01344369|3077949|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.68|||||2-Sided|90.0|92.76|100.77|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1672858|NCT01343004|3078055|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.|||
1673227|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.15||||0.72|2-Sided|95.0|0.53|2.49|||Regression, Logistic||||
1672828|NCT01344369|3077950|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.59|||||2-Sided|90.0|93.69|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1672829|NCT01344369|3077951|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.85|||||2-Sided|90.0|96.43|105.48|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1672830|NCT01344369|3077952|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.58|||||2-Sided|90.0|96.66|104.66|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1672831|NCT01344369|3077953|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.44|||||2-Sided|90.0|93.08|112.75|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1672832|NCT01344161|3077965|Superiority or Other||Mean Difference (Net)|0.05||||0.001|2-Sided|95.0|||||ANCOVA|An analysis of covariance (ANCOVA) was used to adjust mean differences on all variables.|||
1672833|NCT01343888|3077997|Superiority or Other||Koch's method|-0.6|||||2-Sided|95.0|-7.6|6.3|||||adjusted for genotype and race using Koch's method, with continuity correction||
1672834|NCT01343888|3077997|Superiority or Other||Koch's method|27.8|||<|0.0001|2-Sided|95.0|18.2|37.4||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction||
1672835|NCT01343888|3077997|Superiority or Other||Koch's method|27.1|||<|0.0001|2-Sided|95.0|17.5|36.7||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction||
1672836|NCT01343888|3077998|Superiority or Other||Koch's method|-1.0|||||2-Sided|95.0|-7.9|5.8|||||adjusted for genotype and race using Koch's method, with continuity correction||
1672837|NCT01343888|3077998|Superiority or Other||Koch's methond|28.6|||<|0.0001|2-Sided|95.0|19.0|38.2||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction||
1672838|NCT01343888|3077998|Superiority or Other||Koch's method|27.5|||<|0.0001|2-Sided|95.0|17.9|37.0||adjusted for genotype and race|Cochran-Mantel-Haenszel||adjusted for genotype and race using Koch's method, with continuity correction||
1672839|NCT01343407|3078009|Other||LSM Difference|83.29|||<|0.001|2-Sided|90.0|63.9|102.7|||Linear mixed effects model||Full inhibition is ≥74% inhibition of blood eosinophil CD11b expression at trough||
1672840|NCT01343407|3078009|Other||LSM Difference|85.84|||<|0.001|2-Sided|90.0|65.3|106.4|||Linear mixed effects model||Full inhibition is ≥74% inhibition of blood eosinophil CD11b expression at trough||
1672841|NCT01343407|3078010|Other||LS Mean Ratio (LSMR)|0.58||||0.012|2-Sided|90.0|0.41|0.81|||Linear mixed effects model||||% Inhibition: 42.4 (90% CI: 19.3, 58.8) The % Inhibition of FEV1*hr (reduction of the allergen-induced LAR) for MK-1029 vs Placebo was calculated as 100*(1-LSMR).
1672842|NCT01343407|3078010|Other||LS Mean Ratio (LSMR)|0.48||||0.006|2-Sided|90.0|0.32|0.72|||Linear mixed effects model||||% Inhibition: 52.2 (90% CI: 28.3, 68.2). The % Inhibition of FEV1*hr (reduction of the allergen-induced LAR) for MK-1029 vs Placebo was calculated as 100*(1-LSMR).
1672843|NCT01343407|3078011|Other||Difference in LSM|-18.9||||0.023|2-Sided|90.0|-32.1|-5.8|||Linear mixed effects model||||
1672844|NCT01343407|3078011|Other||Difference in Least Squares Means (LSM)|-22.2||||0.011|2-Sided|90.0|-35.7|-8.7|||Linear mixed effects model||||
1672845|NCT01343251|3078033|Superiority or Other|||||||0.9|||||||Chi-squared||||
1672846|NCT01343251|3078034|Superiority or Other|||||||0.04|||||||Chi-squared||||
1672847|NCT01343251|3078035|Superiority or Other||||||<|0.001||||||SF-36 Test 4 Total Score|t-test, 2 sided||||
1672848|NCT01343251|3078035|Superiority or Other||||||<|0.67||||||SF-36 Test 3 Total Score|t-test, 2 sided||||
1672849|NCT01343251|3078035|Superiority or Other||||||<|0.91||||||SF-36 Test 2 Total Score|t-test, 2 sided||||
1672850|NCT01343251|3078035|Superiority or Other||||||<|0.49||||||SF-36 Test 1 Total Score|t-test, 2 sided||||
1672851|NCT01343251|3078036|Superiority or Other|||||||0.02|||||||Chi-squared||||
1672852|NCT01343251|3078037|Superiority or Other|||||||0.48|||||||Chi-squared||||
1672853|NCT01343004|3078054|Superiority or Other|||||||0.3361|||||||Chi-squared||||
1672854|NCT01343004|3078054|Superiority or Other|||||||0.2304|||||||Chi-squared||||
1672855|NCT01343004|3078054|Superiority or Other|||||||0.0318|||||||Chi-squared||||
1672856|NCT01343004|3078055|Superiority or Other|||||||0.0004|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.|||
1672857|NCT01343004|3078055|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.|||
1672859|NCT01343004|3078056|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.|||
1672860|NCT01343004|3078056|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.|||
1672861|NCT01343004|3078056|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.|||
1672862|NCT01343004|3078057|Superiority or Other|||||||0.8155|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.|||
1672863|NCT01343004|3078057|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.|||
1672864|NCT01343004|3078057|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values were derived from contrast tests based on the ANCOVA model fitted using only the data of the two treatment groups to be compared.|||
1672865|NCT01343004|3078058|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1672866|NCT01343004|3078058|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1672867|NCT01342926|3078074|Superiority or Other||Mean Difference (Final Values)|0.5|||||2-Sided|90.0|0.08|0.92|||||18 months visit||
1672868|NCT01342926|3078074|Superiority or Other||Mean Difference (Final Values)|0.2|||||2-Sided|90.0|-0.22|0.62|||||12 months visit||
1672869|NCT01342926|3078074|Superiority or Other||Mean Difference (Final Values)|-0.06|||||2-Sided|90.0|-0.48|0.35|||||6 months visit||
1672870|NCT01342926|3078074|Superiority or Other||Mean Difference (Final Values)|0.12|||||2-Sided|90.0|-0.32|0.55|||||18 months visit||
1672871|NCT01342926|3078074|Superiority or Other||Mean Difference (Final Values)|0.23|||||2-Sided|90.0|-0.21|0.66|||||12 months visit||
1672872|NCT01342926|3078074|Superiority or Other||Mean Difference (Final Values)|-0.08|||||2-Sided|90.0|-0.51|0.35|||||6 months visit||
1672873|NCT01342926|3078074|Superiority or Other||Mean Difference (Final Values)|0.33|||||2-Sided|90.0|-0.12|0.77|||||18 months visit||
1672874|NCT01342926|3078074|Superiority or Other||Mean Difference (Final Values)|0.45|||||2-Sided|90.0|0.0|0.9|||||12 months visit||
1672875|NCT01342926|3078074|Superiority or Other||Mean Difference (Final Values)|0.1|||||2-Sided|90.0|-0.34|0.55|||||6 months visit||
1672876|NCT01342926|3078075|Superiority or Other||Mean Difference (Final Values)|0.91|||||2-Sided|90.0|0.47|1.36|||||18 months visit||
1672877|NCT01342926|3078075|Superiority or Other||Mean Difference (Final Values)|0.54|||||2-Sided|90.0|0.1|0.99|||||12 months visit||
1672878|NCT01342926|3078075|Superiority or Other||Mean Difference (Final Values)|0.13|||||2-Sided|90.0|-0.31|0.57|||||6 months visit||
1672879|NCT01342926|3078075|Superiority or Other||Mean Difference (Final Values)|0.17|||||2-Sided|90.0|-0.3|0.63|||||18 months visit||
1672880|NCT01342926|3078075|Superiority or Other||Mean Difference (Final Values)|0.33|||||2-Sided|90.0|-0.13|0.8|||||12 months visit||
1672881|NCT01342926|3078075|Superiority or Other||Mean Difference (Final Values)|-0.09|||||2-Sided|90.0|-0.55|0.37|||||6 months visit||
1672882|NCT01342926|3078075|Superiority or Other||Mean Difference (Final Values)|0.42|||||2-Sided|90.0|-0.06|0.89|||||18 months visit||
1672883|NCT01342926|3078075|Superiority or Other||Mean Difference (Final Values)|0.41|||||2-Sided|90.0|-0.07|0.89|||||12 months visit||
1672884|NCT01342926|3078075|Superiority or Other||Mean Difference (Final Values)|0.14|||||2-Sided|90.0|-0.34|0.61|||||6 months visit||
1672885|NCT01342926|3078083|Superiority or Other||Median Difference (Final Values)|0.39|||||2-Sided|90.0|-0.08|0.86|||||18 months visit||
1672886|NCT01342926|3078083|Superiority or Other||Median Difference (Final Values)|0.28|||||2-Sided|90.0|-0.19|0.75|||||12 months visit||
1672887|NCT01342926|3078083|Superiority or Other||Mean Difference (Final Values)|-0.18|||||2-Sided|90.0|-0.66|0.29|||||6 months visit||
1672888|NCT01342926|3078083|Superiority or Other||Mean Difference (Final Values)|0.28|||||2-Sided|90.0|-0.21|0.77|||||18 months visit||
1672889|NCT01342926|3078083|Superiority or Other||Mean Difference (Final Values)|0.23|||||2-Sided|90.0|-0.26|0.72|||||12 months visit||
1672890|NCT01342926|3078083|Superiority or Other||Mean Difference (Final Values)|-0.23|||||2-Sided|90.0|-0.71|0.26|||||6 months visit||
1672891|NCT01342926|3078083|Superiority or Other||Mean Difference (Final Values)|0.17|||||2-Sided|90.0|-0.33|0.68|||||18 months visit||
1672892|NCT01342926|3078083|Superiority or Other||Median Difference (Final Values)|0.2|||||2-Sided|90.0|-0.31|0.71|||||12 months visit||
1672893|NCT01342926|3078083|Superiority or Other||Mean Difference (Final Values)|-0.07|||||2-Sided|90.0|-0.57|0.43|||||6 months visit||
1672894|NCT01342913|3078086|Superiority or Other||Least squares mean difference|0.022||||0.282|2-Sided|95.0|-0.018|0.063|||ANCOVA||||
1672895|NCT01342770|3078105|Superiority or Other|||||||0.06|||||||Wilcoxon Signed Rank||||
1672896|NCT01342666|3078110|Superiority or Other||Slope|5.656|Standard Error of the Mean|0.789|<|0.0001|2-Sided|95.0|4.027|7.232||A priori p value of <0.05|Regression, Linear|Adjusted for adherence, smoking, age, gender, waist to hip ratio, triglycerides, body mass index, exercise, omega 3, alcohol, fish, simple sugars.|Parameters of the model: F= 4.06; r = 0.798; r2 = 0.638; p=0.001||
1672897|NCT01342666|3078110|Superiority or Other||Mean Difference (Final Values)|5.1154|Standard Error of the Mean|0.9057|<|0.0001|2-Sided|95.0|3.2925|6.9383||We did only one comparison. The a priori threshold for statistical significance was <0.05.|t-test, 2 sided||We compare de mean difference of the delta (final-basal levels) between groups. The values posted are the difference found in the tomato group in comparison of the control group. The mean represent the increment of HDL-c in the tomato group.|We test the effect of two daily roma tomatoes during one month in HDL-c levels. We estimate the sample size to have a 80% study power.|
1672898|NCT01342640|3078111|Superiority or Other||||||<|0.0001|||||||Paired t-test|||Change from baseline in mean Hb levels at Week 28 was analyzed using paired t-test.|
1672899|NCT01342640|3078112|Superiority or Other||||||<|0.0001|||||||Paired t-test|||Change from baseline in mean Hb levels at Week 24 was analyzed using paired t-test.|
1672900|NCT01342640|3078113|Superiority or Other||||||<|0.0001|||||||Paired t-test|||Change from baseline in mean Hb levels at Week 20 was analyzed using paired t-test.|
1672901|NCT01342523|3078122|Superiority or Other||Odds Ratio (OR)|0.96||||0.555||95.0|0.83|1.11||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full Cessation Booklet vs the Brief Cessation Booklet We hypothesized that the Full Cessation Booklet would result in significantly higher abstinence rates compared to the Brief Cessation Booklet.|
1672902|NCT01342523|3078122|Superiority or Other||Odds Ratio (OR)|1.15||||0.057|2-Sided|95.0|0.996|1.33||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving the Full SmokeFree.gov Website vs the Lite SmokeFree.gov Website . We hypothesized that the Full SmokeFree.gov Website would result in significantly higher abstinence rates compared to the LiteSmokeFree.gov Website .|
1672903|NCT01342523|3078122|Superiority or Other||Odds Ratio (OR)|1.02||||0.755|2-Sided|95.0|0.85|1.13||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving Email Messaging vs No Email Messaging. We hypothesized that Email Messaging would result in significantly higher abstinence rates compared to No Email Messaging.|
1672904|NCT01342523|3078122|Superiority or Other||Odds Ratio (OR)|1.17||||0.028|2-Sided|95.0|1.02|1.36||P-value is not adjusted for multiple comparisons|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving NRT vs No NRT. We hypothesized that NRT would result in significantly higher abstinence rates compared to No NRT.|
1672905|NCT01342523|3078122|Superiority or Other||Odds Ratio (OR)|1.02||||0.825|2-Sided|95.0|0.88|1.17||P-value is not adjusted for multiple comparisons.|Regression, Logistic|The logistic regression model included all 5 treatment main effects and the 10 two-way interactions as well as gender, race, and age as covariates.||Null hypothesis: No difference in 3-month abstinence rates for participants receiving CIS vs No CIS. We hypothesized that CIS would result in significantly higher abstinence rates compared to No CIS.|
1672906|NCT01342484|3078125|Superiority or Other||Mean Difference (Net)|-1.9|Standard Error of the Mean|1.18||0.1189|2-Sided|95.0|-4.31|0.52|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change from baseline in FPG using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline FPG and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.|
1672907|NCT01342484|3078125|Superiority or Other||Mean Difference (Net)|-0.31|Standard Error of the Mean|1.36||0.8216|2-Sided|95.0|-3.08|2.46|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 1 mg minus Placebo.|Superiority of Linagliptin 1 mg vs. placebo: change from baseline in FPG using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c, baseline FPG and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.|
1672908|NCT01342484|3078127|Superiority or Other||Mean Difference (Net)|-0.63|Standard Error of the Mean|0.42||0.1447|2-Sided|95.0|-1.5|0.23|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 5 mg minus Placebo.|Superiority of Linagliptin 5 mg vs. placebo: change from baseline in HbA1c using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c and age as linear covariates; treatment, gender, PK/PD subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.|
1672909|NCT01342484|3078127|Superiority or Other||Mean Difference (Net)|-0.48|Standard Error of the Mean|0.48||0.3295|2-Sided|95.0|-1.47|0.51|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|Mean Difference (Net Values) is actually the adjusted mean difference calculated as Linagliptin 1 mg minus Placebo.|Superiority of Linagliptin 1 mg vs. placebo: change from baseline in HbA1c using a restricted maximum likelihood (REML) - based mixed model repeated measures (MMRM) approach. Model includes baseline HbA1c and age as linear covariates; treatment, gender, pharmacokinetic (PK) / pharmacodynamics (PD) subgroup, background therapy, visit and visit by treatment interaction as fixed effects and patient as a random effect. The unstructured covariance structure has been used to fit the mixed model.|
1672910|NCT01342458|3078133|Superiority or Other||Median Difference (Final Values)|10.0|||<|0.001|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference in paracetamol intake at 6-month.|
1672911|NCT01342458|3078134|Superiority or Other|||||||0.443|||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).|
1672912|NCT01342458|3078135|Superiority or Other|||||||0.425|||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).|
1672913|NCT01342458|3078136|Superiority or Other||Effect size|0.45|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 6th month.|
1672914|NCT01342458|3078136|Superiority or Other||Effect size|0.71|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 3rd month.|
1672915|NCT01342458|3078136|Superiority or Other||Effect size|1.31|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 6th month.|
1672917|NCT01342458|3078136|Superiority or Other||||||<|0.019|||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).|
1672918|NCT01342458|3078137|Superiority or Other||Effect size|0.44|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 6th month.|
1672919|NCT01342458|3078137|Superiority or Other||Effect size|0.66|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 3rd month.|
1672920|NCT01342458|3078137|Superiority or Other||Effect size|1.69|||<|0.019|2-Sided||||||post hoc Newman-Keuls|||From baseline to 6th month.|
1672921|NCT01342458|3078137|Superiority or Other||Effect size|1.45|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 3rd month.|
1672922|NCT01342458|3078137|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).|
1672923|NCT01342458|3078138|Superiority or Other||Effect size|0.42|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 6th month.|
1672924|NCT01342458|3078138|Superiority or Other||Effect size|0.68|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 3rd month.|
1672925|NCT01342458|3078138|Superiority or Other||Effect size|1.58|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 6th month.|
1672926|NCT01342458|3078138|Superiority or Other||Effect size|1.28|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 3rd month.|
1672927|NCT01342458|3078138|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman-Keuls test to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).|
1672928|NCT01342458|3078139|Superiority or Other||Effect size|0.16|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 6th month.|
1672929|NCT01342458|3078139|Superiority or Other||Effect size|0.25|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 3rd month.|
1672930|NCT01342458|3078139|Superiority or Other||Effect size|0.7|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 6th month.|
1672931|NCT01342458|3078139|Superiority or Other||Effect size|0.66|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 3rd month.|
1672932|NCT01342458|3078139|Superiority or Other||||||<|0.015|||||||Mixed Models Analysis|||We used a casewise two-way ANOVA for repeated measures (two independent groups and three repeated measures/assessments), followed by a post hoc Newman–Keuls to verify the interaction effect of group vs. time between T0 (baseline), T3 (3th month) and T6 (6th month).|
1672933|NCT01342458|3078140|Superiority or Other||Effect size|0.66|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 6th month.|
1672934|NCT01342458|3078140|Superiority or Other||Effect size|0.82|||<|0.001|2-Sided||||||post hoc Newman-Keuls|||From baseline to 3rd month.|
1672935|NCT01342458|3078140|Superiority or Other||Effect size|1.94|||<|0.001|2-Sided||||||post hoc Newman Keuls|||From baseline to 6th month.|
1672936|NCT01342458|3078140|Superiority or Other||Effect Size|1.46|||<|0.001|2-Sided||||||post hoc newman keuls|||From baseline to 3rd month.|
1672937|NCT01342458|3078140|Superiority or Other||||||<|0.006|||||||Mixed Models Analysis|||Sample size was calculated based on pain WOMAC score and was accomplished using a moderate effect size (f=0.30). Standard deviation estimates were taken from our previous study. A sample size of 56 patients was needed to provide 80% power for detecting a moderate effect difference between the highest and lowest group pain means, with an alpha level of 0.05, a statistical design of F test of repeated measures (between and within effects), and assuming a 10% loss to follow-up.|
1672938|NCT01342445|3078141|Superiority or Other||partial eta squared|0.28|||<|0.001||||||we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.|ANOVA|"F(4, 84) = 8.14~This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX)."||This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.|
1672939|NCT01342445|3078142|Superiority or Other||Partial eta squared|0.34|||<|0.001||||||we adjusted p values to control for the false discovery rate using procedures described by Benjamini and Hochberg (1995). Thus, an alpha value of .021 was used as significance threshold.|ANOVA|"F(4, 84) = 10.9~This was a one-way ANOVA with repeated measures across dosage conditions (no drug baseline, placebo, 30-mg, 50-mg, 70-mg LDX)."||This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.|
1672940|NCT01342211|3078153|Superiority or Other||Odds Ratio (OR)|20.557||||0.0005|2-Sided|95.0|3.73|113.2|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.|
1672941|NCT01342211|3078153|Superiority or Other||Odds Ratio (OR)|8.029||||0.0072|2-Sided|95.0|1.76|36.65|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.|
1672942|NCT01342211|3078153|Superiority or Other||Odds Ratio (OR)|1.497||||0.6237|2-Sided|95.0|0.3|7.51|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.|
1672943|NCT01342211|3078153|Superiority or Other||Odds Ratio (OR)|1.161||||0.8626|2-Sided|95.0|0.21|6.3|||Regression, Logistic|||Day 85: The standard logistic regression model was used to assess treatment effect.|
1672944|NCT01342211|3078153|Superiority or Other||Odds Ratio (OR)|20.465||||0.0007|2-Sided|95.0|3.59|116.6|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.|
1672945|NCT01342211|3078153|Superiority or Other||Odds Ratio (OR)|7.576||||0.0144|2-Sided|95.0|1.5|38.38|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.|
1674088|NCT01333189|3079223|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Internal moment at the hip|
1672946|NCT01342211|3078153|Superiority or Other||Odds Ratio (OR)|2.175||||0.3786|2-Sided|95.0|0.39|12.27|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.|
1672947|NCT01342211|3078153|Superiority or Other||Odds Ratio (OR)|0.203||||0.321|2-Sided|95.0|0.01|4.74|||Regression, Logistic|||Day 57: The standard logistic regression model was used to assess treatment effect.|
1672948|NCT01342211|3078153|Superiority or Other||Odds Ratio (OR)|71.214||||0.0001|2-Sided|95.0|7.88|643.42|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.|
1672949|NCT01342211|3078153|Superiority or Other||Odds Ratio (OR)|28.151||||0.0002|2-Sided|95.0|4.73|167.62|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.|
1672950|NCT01342211|3078153|Superiority or Other||Odds Ratio (OR)|0.734||||0.742|2-Sided|95.0|0.12|4.63|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.|
1672951|NCT01342211|3078153|Superiority or Other||Odds Ratio (OR)|1.674||||0.5436|2-Sided|95.0|0.32|8.83|||Regression, Logistic|||Day 29: The standard logistic regression model was used to assess treatment effect.|
1672952|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|6.093||||0.0149|2-Sided|95.0|1.42|26.1|||Regression, Logistic|||Day 85, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672953|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|9.548||||0.0036|2-Sided|95.0|2.09|43.57|||Regression, Logistic|||Day 85, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672954|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|1.078||||0.914|2-Sided|95.0|0.28|4.23|||Regression, Logistic|||Day 85, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672955|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|1.844||||0.375|2-Sided|95.0|0.48|7.12|||Regression, Logistic|||Day 85, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672956|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|22.851||||0.002|2-Sided|95.0|3.15|165.99|||Regression, Logistic|||Day 85, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672957|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|21.059||||0.0022|2-Sided|95.0|3.0|147.65|||Regression, Logistic|||Day 85, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672958|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|1.914||||0.5585|2-Sided|95.0|0.22|16.85|||Regression, Logistic|||Day 85, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672959|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|0.359||||0.5449|2-Sided|95.0|0.01|9.92|||Regression, Logistic|||Day 85, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672960|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|8.25||||0.012|2-Sided|95.0|1.59|42.82|||Regression, Logistic|||Day 57, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672961|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|2.251||||0.2235|2-Sided|95.0|0.61|8.31|||Regression, Logistic|||Day 57, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672962|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|1.081||||0.9068|2-Sided|95.0|0.29|3.99|||Regression, Logistic|||Day 57, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672963|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|0.216||||0.0684|2-Sided|95.0|0.04|1.12|||Regression, Logistic|||Day 57, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672964|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|114.508||||0.0022|2-Sided|95.0|5.5|2384.03|||Regression, Logistic|||Day 57, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672965|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|28.286||||0.0273|2-Sided|95.0|1.46|549.78|||Regression, Logistic|||Day 57, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672966|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|1.069||||0.974|2-Sided|95.0|0.02|58.0|||Regression, Logistic|||Day 57, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672967|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|1.131||||0.9519|2-Sided|95.0|0.02|61.54|||Regression, Logistic|||Day 57, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672968|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|13.528||||0.0096|2-Sided|95.0|1.89|97.0|||Regression, Logistic|||Day 29, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672969|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|8.272||||0.0127|2-Sided|95.0|1.57|43.56|||Regression, Logistic|||Day 29, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672970|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|0.579||||0.4308|2-Sided|95.0|0.15|2.25|||Regression, Logistic|||Day 29, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672971|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|0.262||||0.086|2-Sided|95.0|0.06|1.21|||Regression, Logistic|||Day 29, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672972|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|280.366|||<|0.0001|2-Sided|95.0|18.65|4214.35|||Regression, Logistic|||Day 29, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672973|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|53.924|||<|0.0004|2-Sided|95.0|5.93|490.67|||Regression, Logistic|||Day 29, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672974|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|2.063|||<|0.5273|2-Sided|95.0|0.22|19.48|||Regression, Logistic|||Day 29, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1672975|NCT01342211|3078154|Superiority or Other||Odds Ratio (OR)|1.172|||<|0.8998|2-Sided|95.0|0.1|13.92|||Regression, Logistic|||Day 29, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.|
1673228|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.11||||0.75|2-Sided|95.0|0.58|2.13|||Regression, Logistic||||
1672976|NCT01342211|3078155|Superiority or Other||LS Mean Difference|-49.11|Standard Error of the Mean|9.514|<|0.0001|2-Sided|95.0|-68.08|-30.14|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.|
1672977|NCT01342211|3078155|Superiority or Other||LS Mean Difference|-37.72|Standard Error of the Mean|9.404|<|0.0001|2-Sided|95.0|-56.47|-18.97|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.|
1672978|NCT01342211|3078155|Superiority or Other||LS Mean Difference|-2.3|Standard Error of the Mean|9.422|<|0.808|2-Sided|95.0|-21.08|16.49|||ANCOVA|||Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.|
1672979|NCT01342211|3078155|Superiority or Other||Least squares (LS) Mean Difference|-5.63|Standard Error of the Mean|9.759|<|0.5661|2-Sided|95.0|-25.09|13.83|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.|
1672980|NCT01342094|3078164|Superiority or Other||Mean Difference (Final Values)|-1.5|||<|0.001|2-Sided|95.0|-2.2|-0.9|||ANCOVA||||
1672981|NCT01342081|3078165|Non-Inferiority or Equivalence|Non-inferiority margin of 1.5 mmHg was used. Non-inferiority was claimed if the upper limit of the confidence interval of the difference is 1.5 mmHg or less.|Mean Difference (Final Values)|-0.3|||||2-Sided|95.0|-0.7|0.1||||||Non-inferiority was evaluated after superiority to tafluprost was confirmed.|
1672982|NCT01342081|3078165|Superiority or Other||Mean Difference (Final Values)|-1.7|||<|0.001|2-Sided|95.0|-2.1|-1.3|||ANCOVA||||
1672983|NCT01341639|3078180|Other|Miettinen & Nurminen method|Risk Difference (RD)|0.8|||||2-Sided|95.0|-4.4|6.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Vomiting|PR5I minus INFANRIX™ hexa
1672984|NCT01341639|3078180|Other|Miettinen & Nurminen method|Risk Difference (RD)|-3.2|||||2-Sided|95.0|-7.8|1.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Somnolence|PR5I minus INFANRIX™ hexa
1672985|NCT01341639|3078180|Other|Miettinen & Nurminen method|Risk Difference (RD)|-1.7|||||2-Sided|95.0|-6.7|3.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Pyrexia|PR5I minus INFANRIX™ hexa
1672986|NCT01341639|3078180|Other|Miettinen & Nurminen method|Risk Difference (RD)|2.1|||||2-Sided|95.0|-1.7|6.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Irritability|PR5I minus INFANRIX™ hexa
1672987|NCT01341639|3078180|Other|Miettinen & Nurminen method|Risk Difference (RD)|-3.1|||||2-Sided|95.0|-8.4|2.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Decreased appetite|PR5I minus INFANRIX™ hexa
1672988|NCT01341639|3078180|Other|Miettinen & Nurminen method.|Risk Difference (RD)|-2.5|||||2-Sided|95.0|-6.3|1.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Crying|PR5I minus INFANRIX™ hexa
1672989|NCT01341639|3078181|Other|Miettinen & Nurminen method|Risk Difference (RD)|1.1||||||95.0|-0.6|3.0|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site warmth|PR5I minus INFANRIX™ hexa
1672990|NCT01341639|3078181|Other|Miettinen & Nurminen method|Risk Difference (RD)|-0.2|||||2-Sided|95.0|-1.7|1.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site nodule|PR5I minus INFANRIX™ hexa
1672991|NCT01341639|3078181|Other|Miettinen & Nurminen method|Risk Difference (RD)|-3.7|||||2-Sided|95.0|-7.8|0.5|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site induration|PR5I minus INFANRIX™ hexa
1672992|NCT01341639|3078181|Other|Miettinen & Nurminen method|Risk Difference (RD)|-0.7|||||2-Sided|95.0|-2.3|0.8|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site haemorrhage|PR5I minus INFANRIX™ hexa
1672993|NCT01341639|3078181|Other|Miettinen & Nurminen method|Risk Difference (RD)|0.6|||||2-Sided|95.0|-0.6|2.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site haematoma|PR5I minus INFANRIX™ hexa
1672994|NCT01341639|3078181|Other|Miettinen & Nurminen method|Risk Difference (RD)|0.1|||||2-Sided|95.0|-1.8|2.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site bruising|PR5I minus INFANRIX™ hexa
1672995|NCT01341639|3078182|Other|Miettinen & Nurminen method|Risk Difference (RD)|4.0|||||2-Sided|95.0|-1.6|9.6|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site swelling|PR5I minus INFANRIX™ hexa
1672996|NCT01341639|3078182|Other|Miettinen & Nurminen method|Risk Difference (RD)|1.8|||||2-Sided|95.0|-3.2|6.8|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site pain|PR5I minus INFANRIX™ hexa
1672997|NCT01341639|3078182|Other|Miettinen & Nurminen method|Risk Difference (RD)|4.8|||||2-Sided|95.0|-0.5|10.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: Injection-site erythema|PR5I minus INFANRIX™ hexa
1672998|NCT01341639|3078183|Other|Miettinen & Nurminen method|Risk Difference (RD)|-1.3|||||2-Sided|95.0|-3.7|1.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 vaccine-related solicited systemic AE|PR5I minus INFANRIX™ hexa
1672999|NCT01341639|3078183|Other|Miettinen & Nurminen method|Risk Difference (RD)|-1.5|||||2-Sided|95.0|-3.3|0.2|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 solicited systemic AE|PR5I minus INFANRIX™ hexa
1673000|NCT01341639|3078183|Other|Miettinen & Nurminen method|Risk Difference (RD)|-0.9|||||2-Sided|95.0|-3.2|1.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 vaccine-related systemic AE|PR5I minus INFANRIX™ hexa
1673001|NCT01341639|3078183|Other|Miettinen & Nurminen method|Risk Difference (RD)|-1.0|||||2-Sided|95.0|-2.4|0.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 systemic AE|PR5I minus INFANRIX™ hexa
1673002|NCT01341639|3078183|Other|Miettinen & Nurminen method|Risk Difference (RD)|0.9|||||2-Sided|95.0|-2.4|4.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 solicited ISR|PR5I minus INFANRIX™ hexa
1673003|NCT01341639|3078183|Other|Miettinen & Nurminen method|Risk Difference (RD)|1.1|||||2-Sided|95.0|-2.1|4.3|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: At least 1 ISR|PR5I minus INFANRIX™ hexa
1673004|NCT01341639|3078183|Other|Miettinen & Nurminen method|Risk Difference (RD)|-0.3|||||2-Sided|95.0|-1.8|1.1|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: ISRs or vaccine-related systemic AEs|PR5I minus INFANRIX™ hexa
1673005|NCT01341639|3078183|Other|Miettinen & Nurminen method|Risk Difference (RD)|-0.7|||||2-Sided|95.0|-1.9|0.4|||||If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.|Risk difference: ISRs or systemic AEs|PR5I minus INFANRIX™ hexa
1673006|NCT01341639|3078184|Non-Inferiority|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.02|||<|0.001|2-Sided|95.0|-2.11|2.06||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Varicella|PR5I minus INFANRIX™ hexa
1673007|NCT01341639|3078184|Non-Inferiority|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.39|||<|0.001|2-Sided|95.0|-1.5|2.34||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Rubella|PR5I minus INFANRIX™ hexa
1673008|NCT01341639|3078184|Non-Inferiority|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|3.07|||<|0.001|2-Sided|95.0|-0.12|6.4||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Mumps|PR5I minus INFANRIX™ hexa
1673009|NCT01341639|3078184|Non-Inferiority|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-0.26|||<|0.001|2-Sided|95.0|-2.82|2.25||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Measles|PR5I minus INFANRIX™ hexa
1673010|NCT01341639|3078186|Non-Inferiority|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.03|||<|0.001|2-Sided|95.0|-1.4|1.52||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PRN|PR5I minus INFANRIX™ hexa
1673011|NCT01341639|3078186|Non-Inferiority|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|-2.59|||<|0.001|2-Sided|95.0|-4.39|-1.29||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for FHA|PR5I minus INFANRIX™ hexa
1673012|NCT01341639|3078186|Non-Inferiority|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|1.33|||<|0.001|2-Sided|95.0|0.32|2.86||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PT|PR5I minus INFANRIX™ hexa
1673013|NCT01341639|3078186|Non-Inferiority|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.58|||<|0.001|2-Sided|95.0|-0.49|1.85||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for HBsAg|PR5I minus INFANRIX™ hexa
1673014|NCT01341639|3078187|Non-Inferiority|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|2-Sided|95.0|-0.7|0.73||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV3|PR5I minus INFANRIX™ hexa
1673015|NCT01341639|3078187|Non-Inferiority|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.19|||<|0.001|2-Sided|95.0|-0.69|1.21||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV2|PR5I minus INFANRIX™ hexa
1673229|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.26||||0.55|2-Sided|95.0|0.59|2.68|||Regression, Logistic||||
1673016|NCT01341639|3078187|Non-Inferiority|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.19|||<|0.001|2-Sided|95.0|-0.51|1.07||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for IPV1|PR5I minus INFANRIX™ hexa
1673017|NCT01341639|3078187|Non-Inferiority|If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|2-Sided|95.0|-0.71|0.74|||Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Tetanus|PR5I minus INFANRIX™ hexa
1673018|NCT01341639|3078187|Non-Inferiority|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|0.0|||<|0.001|2-Sided|95.0|-0.95|0.96||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for Diphtheria|PR5I minus INFANRIX™ hexa
1673019|NCT01341639|3078187|Non-Inferiority|If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages|11.37|||<|0.001|2-Sided|95.0|8.44|14.68||1-sided|Miettinen & Nurminen||If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.|Difference in percentages: Non-inferiority for PRP|PR5I minus INFANRIX™ hexa
1673020|NCT01340937|3078224|Superiority or Other||Mean Difference (Final Values)|1.1|||||2-Sided|95.0|-0.7|2.1|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, rectal >=39.5°C|
1673021|NCT01340937|3078224|Superiority or Other||Mean Difference (Final Values)|8.4|||||2-Sided|95.0|4.6|11.6|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, rectal >=38.5°C and <39.5°C|
1673022|NCT01340937|3078224|Superiority or Other||Mean Difference (Final Values)|3.5|||||2-Sided|95.0|-1.4|7.8|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference; rectal >=38.0°C and <38.5°C|
1673023|NCT01340937|3078224|Superiority or Other||Mean Difference (Final Values)|-11.3|||||2-Sided|95.0|-16.6|-5.9|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference; rectal <38.0°C|
1673024|NCT01340937|3078224|Superiority or Other||Mean Difference (Final Values)|1.1|||||2-Sided|95.0|-0.7|2.2|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes >=39.5°C|
1673025|NCT01340937|3078224|Superiority or Other||Mean Difference (Final Values)|8.7|||||2-Sided|95.0|4.8|11.9|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes >=38.5°C and <39.5°|
1673026|NCT01340937|3078224|Superiority or Other||Mean Difference (Final Values)|3.9|||||2-Sided|95.0|-0.9|8.3|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes >=38°C and <38.5°|
1673027|NCT01340937|3078224|Superiority or Other||Mean Difference (Final Values)|-13.7|||||2-Sided|95.0|-18.8|-8.4|||||Mean Difference is V419 - Control. The 95% confidence interval is based on the unstratified Miettinen and Nurminen method.|Estimated Difference, all routes <38.0°C|
1673028|NCT01340937|3078226|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.9|||<|0.001|2-Sided|95.0|0.77|1.06|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 23F|
1673029|NCT01340937|3078226|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.97|||<|0.001|2-Sided|95.0|0.87|1.08|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 19F|
1673030|NCT01340937|3078226|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.91|||<|0.001|2-Sided|95.0|0.8|1.03|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 19A|
1673031|NCT01340937|3078226|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.89|||<|0.001|2-Sided|95.0|0.79|1.0|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 18C|
1673032|NCT01340937|3078226|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.95|||<|0.001|2-Sided|95.0|0.82|1.1|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 14|
1673033|NCT01340937|3078226|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|1.0|||<|0.001|2-Sided|95.0|0.88|1.13|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 9V|
1673053|NCT01340937|3078236|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5%|Response Rate Difference (Comb - Ctrl)|0.0|||<|0.001|2-Sided|95.0|-0.2|1.24|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673034|NCT01340937|3078226|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.89|||<|0.001|2-Sided|95.0|0.8|0.99|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 7F|
1673035|NCT01340937|3078226|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.79|||<|0.055|2-Sided|95.0|0.64|0.96|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 6B|
1673036|NCT01340937|3078226|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.87|||<|0.001|2-Sided|95.0|0.77|0.99|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 6A|
1673037|NCT01340937|3078226|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.93|||<|0.001|2-Sided|95.0|0.8|1.07|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 5|
1673038|NCT01340937|3078226|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|1.0|||<|0.001|2-Sided|95.0|0.89|1.12|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 4|
1673039|NCT01340937|3078226|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.95|||<|0.001|2-Sided|95.0|0.84|1.06|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 3|
1673040|NCT01340937|3078226|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.92|||<|0.001|2-Sided|95.0|0.82|1.04|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Pneumococcal Serotype 1|
1673041|NCT01340937|3078227|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (Comb - Ctrl)|3.0|||<|0.001|2-Sided|95.0|-0.39|7.4|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673042|NCT01340937|3078228|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (Comb - Ctrl)|1.15|||<|0.001|2-Sided|95.0|-2.13|5.47|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673043|NCT01340937|3078229|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (Comb - Ctrl)|-0.16|||<|0.001|2-Sided|95.0|-2.41|3.22|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673044|NCT01340937|3078230|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (Comb - Ctrl)|0.12|||<|0.001|2-Sided|95.0|-1.11|2.58|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673045|NCT01340937|3078231|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|1.31|||<|0.001|2-Sided|95.0|1.17|1.46|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673046|NCT01340937|3078232|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.74||||0.035|2-Sided|95.0|0.66|0.83|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673047|NCT01340937|3078233|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.86|||<|0.001|2-Sided|95.0|0.79|0.95|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673048|NCT01340937|3078234|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|1.07|||<|0.001|2-Sided|95.0|0.98|1.17|||Analysis of Covariance|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673049|NCT01340937|3078235|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5%|Response Rate Difference (Comb - Ctrl)|0.33|||<|0.001|2-Sided|95.0|0.05|1.85|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673050|NCT01340937|3078235|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||<||2-Sided|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673051|NCT01340937|3078235|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||<||2-Sided|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673052|NCT01340937|3078235|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||<||2-Sided|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1674089|NCT01333189|3079224|Superiority or Other||||||=|0|||||||Mixed Models Analysis||||
1673054|NCT01340937|3078236|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||<||2-Sided|95.0|-0.61|0.6|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673055|NCT01340937|3078236|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||<||2-Sided|95.0|-0.61|0.6|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673056|NCT01340937|3078236|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||<||2-Sided|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673057|NCT01340937|3078237|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5%|Response Rate Difference (Comb - Ctrl)|0.66|||<|0.001|2-Sided|95.0|0.18|2.36|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673058|NCT01340937|3078237|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||<||2-Sided|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673059|NCT01340937|3078237|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|0.0|||<||2-Sided|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673060|NCT01340937|3078237|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|0.0|||<||2-Sided|95.0|-0.61|0.61|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673061|NCT01340937|3078238|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (Comb - Ctrl)|2.85|||<|0.001|2-Sided|95.0|-0.85|7.36|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673062|NCT01340937|3078238|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-0.07|||<||2-Sided|95.0|-3.32|3.2|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673063|NCT01340937|3078238|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-4.17|||<||2-Sided|95.0|-7.75|-0.66|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673064|NCT01340937|3078238|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-4.12|||<||2-Sided|95.0|-7.69|-0.63|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673065|NCT01340937|3078239|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (Comb - Ctrl)|3.28|||<|0.001|2-Sided|95.0|-1.7|8.85|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673066|NCT01340937|3078239|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-0.36|||<||2-Sided|95.0|-5.14|4.42|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673067|NCT01340937|3078239|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|2.41|||<||2-Sided|95.0|-2.21|7.06|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673068|NCT01340937|3078239|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|2.77|||<||2-Sided|95.0|-1.83|7.39|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673069|NCT01340937|3078240|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (Comb - Ctrl)|-4.7|||<|0.001|2-Sided|95.0|-7.73|-0.86|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673070|NCT01340937|3078240|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.71|||<||2-Sided|95.0|-5.37|1.94|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673071|NCT01340937|3078240|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-3.06|||<||2-Sided|95.0|-6.79|0.67|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673072|NCT01340937|3078240|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-1.35|||<||2-Sided|95.0|-5.17|2.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673073|NCT01340937|3078241|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (Comb - Ctrl)|0.72|||<|0.001|2-Sided|95.0|-0.59|3.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673074|NCT01340937|3078241|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.36|||<||2-Sided|95.0|-3.03|0.15|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673075|NCT01340937|3078241|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|0.36|||<||2-Sided|95.0|-0.77|1.63|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673076|NCT01340937|3078241|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|1.73|||<||2-Sided|95.0|0.37|3.4|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673077|NCT01340937|3078242|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5%|Response Rate Difference (Comb - Ctrl)|1.28|||<|0.001|2-Sided|95.0|0.46|3.33|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673078|NCT01340937|3078242|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot B - Lot C)|0.0|||<||2-Sided|95.0|-0.63|0.62|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673079|NCT01340937|3078242|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot C)|-0.16|||<||2-Sided|95.0|-0.9|0.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673080|NCT01340937|3078242|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -5% and 5%|Response Rate Difference (Lot A - Lot B)|-0.16|||<||2-Sided|95.0|-0.91|0.47|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673081|NCT01340937|3078243|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (Comb - Ctrl)|-2.35|||<|0.001|2-Sided|95.0|-6.02|2.09|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673082|NCT01340937|3078243|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.64|||<||2-Sided|95.0|-5.56|2.28|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673083|NCT01340937|3078243|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-1.35|||<||2-Sided|95.0|-5.26|2.57|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673084|NCT01340937|3078243|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|0.25|||<||2-Sided|95.0|-3.74|4.24|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673085|NCT01340937|3078244|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (Comb - Ctrl)|0.92|||<|0.001|2-Sided|95.0|0.2|2.9|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673086|NCT01340937|3078244|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|0.0|||<||2-Sided|95.0|-0.64|0.66|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673087|NCT01340937|3078244|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-0.34|||<||2-Sided|95.0|-1.23|0.32|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673088|NCT01340937|3078244|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-0.34|||<||2-Sided|95.0|-1.23|0.3|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine||
1673089|NCT01340937|3078245|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|1.03|||||2-Sided|95.0|0.9|1.19|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673090|NCT01340937|3078245|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|1.09|||||2-Sided|95.0|0.95|1.26|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673091|NCT01340937|3078245|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|1.06|||||2-Sided|95.0|0.92|1.22|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673092|NCT01340937|3078246|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|0.98|||||2-Sided|95.0|0.87|1.09|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673093|NCT01340937|3078246|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|0.91|||||2-Sided|95.0|0.82|1.02|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673094|NCT01340937|3078246|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|0.94|||||2-Sided|95.0|0.84|1.05|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673095|NCT01340937|3078247|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot B/Lot C)|1.03|||||2-Sided|95.0|0.92|1.15|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673096|NCT01340937|3078247|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMT ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot C)|0.88|||||2-Sided|95.0|0.79|0.99|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673097|NCT01340937|3078247|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the Geometric Mean Titer (GMT) ratio are within the margin 0.67 to 1.5|GMT Ratio (Lot A/Lot B)|0.86|||||2-Sided|95.0|0.76|0.96|||||GMT ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673098|NCT01340937|3078248|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|1.51|||<|0.001|2-Sided|95.0|1.37|1.66|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis|
1673099|NCT01340937|3078248|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.02|||<||2-Sided|95.0|0.93|1.11|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673100|NCT01340937|3078248|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.8|||<||2-Sided|95.0|0.73|0.87|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673101|NCT01340937|3078248|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.78|||<||2-Sided|95.0|0.72|0.85|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673102|NCT01340937|3078249|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|1.03|||<|0.001|2-Sided|95.0|0.9|1.17|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis|
1673103|NCT01340937|3078249|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.96|||<||2-Sided|95.0|0.85|1.08|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673104|NCT01340937|3078249|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.93|||<||2-Sided|95.0|0.83|1.05|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673105|NCT01340937|3078249|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.97|||<||2-Sided|95.0|0.87|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673106|NCT01340937|3078250|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|0.67||||0.419|2-Sided|95.0|0.62|0.73|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis|
1673107|NCT01340937|3078250|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.87|||||2-Sided|95.0|0.81|0.94|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673108|NCT01340937|3078250|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.78|||||2-Sided|95.0|0.72|0.83|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673109|NCT01340937|3078250|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.89|||||2-Sided|95.0|0.83|0.96|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673110|NCT01340937|3078251|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|1.2|||<|0.001|2-Sided|95.0|1.11|1.29|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||Secondary analysis|
1673111|NCT01340937|3078251|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.99|||<||2-Sided|95.0|0.92|1.06|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673112|NCT01340937|3078251|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|1.02|||<||2-Sided|95.0|0.95|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673113|NCT01340937|3078251|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|1.03|||<||2-Sided|95.0|0.96|1.1|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673114|NCT01340937|3078252|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.05|||||2-Sided|95.0|0.98|1.13|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673115|NCT01340937|3078252|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|1.02|||||2-Sided|95.0|0.95|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673116|NCT01340937|3078252|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.97|||||2-Sided|95.0|0.91|1.04|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673117|NCT01340937|3078253|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|1.02|||||2-Sided|95.0|0.9|1.14|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673118|NCT01340937|3078253|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.97|||||2-Sided|95.0|0.86|1.09|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673119|NCT01340937|3078253|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.95|||||2-Sided|95.0|0.84|1.07|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673120|NCT01340937|3078254|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.98|||||2-Sided|95.0|0.86|1.11|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673121|NCT01340937|3078254|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.85|||||2-Sided|95.0|0.74|0.96|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673122|NCT01340937|3078254|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.87|||||2-Sided|95.0|0.76|0.98|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673123|NCT01340937|3078255|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5%|Response Rate Difference (Comb - Ctrl)|2.2|||<|0.001|2-Sided|95.0|0.39|5.12|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer >=0.15 µg/mL|
1673124|NCT01340937|3078255|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (Comb - Ctrl)|7.93|||<|0.001|2-Sided|95.0|3.38|13.17|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer >=1 µg/mL|
1673125|NCT01340937|3078255|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot B - Lot C)|-1.16|||<||2-Sided|95.0|-4.89|2.58|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer >=1 µg/mL|
1673126|NCT01340937|3078255|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot C)|-1.62|||<||2-Sided|95.0|-5.38|2.12|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer >=1 µg/mL|
1673127|NCT01340937|3078255|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% Confidence Intervals of the response rate difference are between -10% and 10%|Response Rate Difference (Lot A - Lot B)|-0.48|||<||2-Sided|95.0|-4.31|3.35|||||Response rate difference was stratified by brand of birth dose of Hepatitis B vaccine|Equivalence for titer >=1 µg/mL|
1673128|NCT01340937|3078256|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (Combined/Control)|1.63|||<|0.001|2-Sided|95.0|1.35|1.98|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673129|NCT01340937|3078256|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot B/Lot C)|0.94|||<||2-Sided|95.0|0.79|1.12|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673130|NCT01340937|3078256|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the GMC ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot C)|0.86|||<||2-Sided|95.0|0.72|1.02|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673131|NCT01340937|3078256|Non-Inferiority or Equivalence|Equivalence requires that the 2-sided 95% confidence intervals of the Geometric Mean Concentration (GMC) ratio are within the margin 0.67 to 1.5|GMC Ratio (Lot A/Lot B)|0.91|||<||2-Sided|95.0|0.77|1.08|||||GMC ratio was adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine||
1673132|NCT01340898|3078291|Superiority or Other||Percentage of subjects|99.7|||||2-Sided|95.0|98.3|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup Y one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants|
1673133|NCT01340898|3078291|Superiority or Other||Percentage of subjects|99.4|||||2-Sided|95.0|97.8|99.9|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup W-135 one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants|
1673188|NCT01340209|3078400|Superiority or Other||Mean Difference (Final Values)|6.216|Standard Error of the Mean|9.238||0.5013||95.0|-11.927|24.359|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment*week and baseline*week||Difference calculated as Tiotropium 5 μg minus placebo|
1673134|NCT01340898|3078291|Superiority or Other||Percentage of subjects|99.7|||||2-Sided|95.0|98.3|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup C one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants.|
1673135|NCT01340898|3078291|Superiority or Other||Percentage of subjects|100.0|||||2-Sided|95.0|98.9|100.0|||||Immunogenicity was considered demonstrated if the lower limit of the two-sided exact 95% confidence interval (CI) for the percentage of subjects with rSBA titre ≥ 1:8 was greater than or equal to the pre-defined clinical limit of 80%.|Demonstration of the immunogenicity of the Nimenrix™ conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroup A one-month post-dose 3 of Nimenrix™ vaccine at 7 months of age in healthy infants|
1673136|NCT01340872|3078300|Superiority||Mean Difference (Final Values)|2.15|Standard Error of the Mean|0.16|<|0.0001|1-Sided|97.5|1.82||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12|
1673137|NCT01340872|3078301|Superiority||Mean Difference (Final Values)|2.18|Standard Error of the Mean|0.17|<|0.0001|1-Sided|97.5|1.87||||ANCOVA|||ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS|
1673138|NCT01340872|3078312|Superiority||Mean Difference (Final Values)|1.73|Standard Error of the Mean|0.15|<|0.0001|1-Sided|97.5|1.43||||ANCOVA|||ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|
1673139|NCT01340872|3078313|Superiority||Mean Difference (Final Values)|1.04|Standard Error of the Mean|0.11|<|0.0001|1-Sided|97.5|0.82||||ANCOVA|||ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|
1673140|NCT01340872|3078317|Superiority||Mean Difference (Final Values)|2.18|Standard Error of the Mean|0.19|<|0.0001|1-Sided|97.5|1.81||||ANCOVA|||ANCOVA for primary endpoint, Change in Hb concentration from Baseline to Week 12 in double-blind phase, FAS|
1673141|NCT01340768|3078323|Superiority or Other||Risk Ratio (RR)|0.49||||0.006|2-Sided|95.0|0.29|0.83||P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).|Cochran-Mantel-Haenszel||||
1673142|NCT01340768|3078324|Superiority or Other||Risk Ratio (RR)|0.52||||0.028|2-Sided|95.0|0.29|0.94||P-value for association between treatment groups and proportions controlling for prior therapy (monotherapy or combination therapy).|Cochran-Mantel-Haenszel||||
1673143|NCT01340664|3078325|Superiority or Other||Odds Ratio (OR)|3.38|||<|0.001|2-Sided|95.0|1.68|6.81|||Regression, Logistic||||
1673144|NCT01340664|3078325|Superiority or Other||Odds Ratio (OR)|2.43|||<|0.013|2-Sided|95.0|1.21|4.9|||Regression, Logistic||||
1673145|NCT01340664|3078326|Superiority or Other||Least-Squares Mean Difference|-2.6|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|-3.5|-1.7|||ANCOVA||||
1673146|NCT01340664|3078326|Superiority or Other||Least-Squares Mean Difference|-2.2|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|-3.1|-1.3|||ANCOVA||||
1673147|NCT01340664|3078327|Superiority or Other||Least-Sqaures Mean Difference|-24.0|Standard Error of the Mean|4.661|<|0.001||95.0|-33.18|-14.83|||ANCOVA||||
1673148|NCT01340664|3078327|Superiority or Other||Least-Sqaures Mean Difference|-23.6|Standard Error of the Mean|4.673|<|0.001|2-Sided|95.0|-32.78|-14.38|||ANCOVA||||
1673149|NCT01340664|3078328|Superiority or Other||Least-Squares Mean Difference|-0.6|Standard Error of the Mean|0.098|<|0.001|2-Sided|95.0|-0.792|-0.407|||ANCOVA||||
1673150|NCT01340664|3078328|Superiority or Other||Least-Squares Mean Difference|-0.44|Standard Error of the Mean|0.098|<|0.001|2-Sided|95.0|-0.637|-0.251|||ANCOVA||||
1673151|NCT01340625|3078339|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.59|||||2-Sided|90.0|94.91|104.5|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1673152|NCT01340625|3078340|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.8|||||2-Sided|90.0|93.89|103.97|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1673153|NCT01340625|3078341|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.24|||||2-Sided|90.0|90.04|102.86|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1673154|NCT01340625|3078342|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.97|||||2-Sided|90.0|95.73|108.62|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1673230|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.24||||0.57|2-Sided|95.0|0.59|2.61|||Regression, Logistic||||
1673155|NCT01340625|3078343|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.03|||||2-Sided|90.0|96.74|111.88|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1673156|NCT01340625|3078344|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.84|||||2-Sided|90.0|100.91|115.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1673157|NCT01340586|3078366|Superiority or Other||Geometric Mean Ratio|0.858|||||2-Sided|90.0|0.707|1.042||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis|
1673158|NCT01340586|3078366|Superiority or Other||Geometric Mean Ratio|1.357|||||2-Sided|90.0|1.066|1.728||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function|
1673159|NCT01340586|3078366|Superiority or Other||Geometric Mean Ratio|1.165|||||2-Sided|90.0|0.88|1.543||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function|
1673160|NCT01340586|3078368|Superiority or Other||Geometric Mean Ratio|0.855|||||2-Sided|90.0|0.707|1.033||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis|
1673161|NCT01340586|3078368|Superiority or Other||Geometric Mean Ratio|1.389|||||2-Sided|90.0|1.097|1.758||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function|
1673162|NCT01340586|3078368|Superiority or Other||Geometric Mean Ratio|1.187|||||2-Sided|90.0|0.907|1.553||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function|
1673163|NCT01340586|3078370|Superiority or Other||Geometric Mean Ratio|0.871|||||2-Sided|90.0|0.723|1.049||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over ESRD Dose after hemodialysis|
1673164|NCT01340586|3078370|Superiority or Other||Geometric Mean Ratio|0.904|||||2-Sided|90.0|0.697|1.173||||||Geometric Mean Ratio: ESRD Dose after hemodialysis over Normal Renal Function|
1673165|NCT01340586|3078370|Superiority or Other||Geometric Mean Ratio|0.787|||||2-Sided|90.0|0.616|1.006||||||Geometric Mean Ratio: ESRD Dose before hemodialysis over Normal Renal Function|
1673166|NCT01340300|3078389|Superiority|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of Waist to Hip Ratio in treatment arm is greater than the control arm.|
1673167|NCT01340300|3078390|Superiority|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.|
1673168|NCT01340300|3078390|Superiority||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.|
1673169|NCT01340300|3078390|Superiority||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of BMI in treatment arm is greater than the control arm.|
1673170|NCT01340300|3078391|Superiority|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.|
1673171|NCT01340300|3078391|Superiority||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.|
1673172|NCT01340300|3078391|Superiority||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of Weight in treatment arm is greater than the control arm.|
1673189|NCT01340209|3078400|Superiority or Other||Mean Difference (Final Values)|8.646|Standard Error of the Mean|9.182||0.3468|2-Sided|95.0|-9.388|26.68|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment*week and baseline*week||Difference calculated as Tiotropium 2.5 µg minus placebo|
1673173|NCT01340300|3078392|Superiority|||||||0.007||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.|
1673174|NCT01340300|3078392|Superiority|||||||0.0004||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of Glucose in treatment arm is greater than the control arm.|
1673175|NCT01340300|3078393|Superiority|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.|
1673176|NCT01340300|3078393|Superiority|||||||0.0002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of Leptin in combined arm is greater than the exercise-only or metformin-only arm.|
1673177|NCT01340300|3078393|Superiority|||||||0.02||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of IGFBP_1 in treatment arm is greater than the control arm.|
1673178|NCT01340300|3078393|Superiority|||||||0.002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of IGFBP_1 in treatment arm is greater than the control arm.|
1673179|NCT01340300|3078393|Superiority|||||||0.0002||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of leptin in treatment arm is greater than the control arm.|
1673180|NCT01340300|3078394|Superiority|||||||0.03||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of Insulin in combined arm is greater than the exercise-only or metformin-only arm.|
1673181|NCT01340300|3078394|Superiority|||||||0.01||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.|
1673182|NCT01340300|3078394|Superiority|||||||0.003||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.|
1673183|NCT01340300|3078394|Superiority||||||<|0.0001||||||One-sided un-adjusted p-values to test if the decrease in treatment arm is greater than the control arm. Holm's method was performed for multiple comparisons to provide an overall significance level of 5%. Only significant p-values were reported.|Mixed Models Analysis|An intention-to-treat analysis, with a mixed model that was adjusted for baseline outcome value, BMI (< 30 or > 30), gender, cancer, and study site.||Null hypothesis: decrease of insulin in treatment arm is greater than the control arm.|
1673184|NCT01340209|3078398|Superiority or Other||Mean Difference (Final Values)|0.564|Standard Error of the Mean|1.038||0.5871|2-Sided|95.0|-1.473|2.601|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment*week and baseline*week||Difference calculated as Tiotropium 5 μg minus placebo|
1673185|NCT01340209|3078398|Superiority or Other||Mean Difference (Final Values)|-0.601|Standard Error of the Mean|1.038||0.5629|2-Sided|95.0|-2.637|1.436|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment*week and baseline*week||Difference calculated as Tiotropium 2.5 µg minus placebo|
1673186|NCT01340209|3078399|Superiority or Other||Mean Difference (Final Values)|16.398|Standard Error of the Mean|9.245||0.0766|2-Sided|95.0|-1.759|34.555|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment*week and baseline*week||Difference calculated as Tiotropium 5 μg minus placebo|
1673187|NCT01340209|3078399|Superiority or Other||Mean Difference (Final Values)|11.458|Standard Error of the Mean|9.196||0.2132|2-Sided|95.0|-6.601|29.517|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment*week and baseline*week||Difference calculated as Tiotropium 2.5 µg minus placebo|
1673190|NCT01340209|3078401|Superiority or Other||Median Difference (Final Values)|34.176|Standard Error of the Mean|12.346||0.0058|2-Sided|95.0|9.919|58.432|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment*week and baseline*week||Difference calculated as Tiotropium Respimat 5 μg minus placebo|
1673191|NCT01340209|3078401|Superiority or Other||Mean Difference (Final Values)|0.498|Standard Error of the Mean|12.282||0.9677|2-Sided|95.0|-23.634|24.63|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment*week and baseline*week||Difference calculated as Tiotropium 2.5 µg minus placebo|
1673192|NCT01340209|3078402|Superiority or Other||Mean Difference (Final Values)|0.082|Standard Error of the Mean|0.054||0.127|2-Sided|95.0|-0.023|0.188|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment*week and baseline*week||Difference calculated as Tiotropium 5 μg minus placebo|
1673193|NCT01340209|3078402|Superiority or Other||Mean Difference (Final Values)|-0.037|Standard Error of the Mean|0.053||0.4944|2-Sided|95.0|-0.141|0.068|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment*week and baseline*week||Difference calculated as Tiotropium 2.5 µg minus placebo|
1673194|NCT01340209|3078403|Superiority or Other||Mean Difference (Final Values)|0.112|Standard Error of the Mean|0.048||0.0203|2-Sided|95.0|0.018|0.207|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment*week and baseline*week||Difference calculated as Tiotropium 5 μg minus placebo|
1673195|NCT01340209|3078403|Superiority or Other||Mean Difference (Final Values)|0.012|Standard Error of the Mean|0.048||0.7971|2-Sided|95.0|-0.082|0.106|||Mixed Models Analysis|adjusted for treatment, week, baseline, treatment*week and baseline*week||Difference calculated as Tiotropium 2.5 µg minus placebo|
1673196|NCT01340196|3078407|Superiority or Other||Geometric mean ratio|75.27|Standard Deviation|13.7|||2-Sided|90.0|68.71|82.45|||||The standard deviation is actually the intra-individual gCV.||
1673197|NCT01340196|3078408|Superiority or Other||Geometric mean ratio|81.73|Standard Deviation|20.1|||2-Sided|90.0|71.56|93.34|||||The standard deviation is actually the intra-individual gCV.||
1673198|NCT01340196|3078409|Superiority or Other||Geometric mean ratio|77.88|Standard Deviation|13.4|||2-Sided|90.0|71.24|85.15|||||The standard deviation is actually the intra-individual gCV.||
1673199|NCT01340196|3078410|Superiority or Other||Geometric mean ratio|147.12|Standard Deviation|14.6||||90.0|134.482|160.943|||||The standard deviation is actually the intra-individual gCV.||
1673200|NCT01340196|3078411|Superiority or Other||Geometric mean ratio|94.72|Standard Deviation|17.2|||2-Sided|90.0|85.215|105.29|||||The standard deviation is actually the intra-individual gCV.||
1673201|NCT01340196|3078412|Superiority or Other||Geometric mean ratio|121.89|Standard Deviation|14.1|||2-Sided|90.0|111.714|132.999|||||The standard deviation is actually the intra-individual geometric coefficient of variation (gCV).||
1673202|NCT01340066|3078414|Superiority or Other||Mean Difference (Final Values)|0.0||||0.92|1-Sided|80.0|||||Chi-squared||||
1673203|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|1.28|Standard Error of the Mean|0.421||0.002|2-Sided|95.0|0.45|2.1|||ANCOVA||||
1673204|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|1.07|Standard Error of the Mean|0.423||0.012|2-Sided|95.0|0.24|1.9|||ANCOVA||||
1673205|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.8|Standard Error of the Mean|0.369||0.031|2-Sided|95.0|0.07|1.52|||ANCOVA||||
1673206|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|1.03|Standard Error of the Mean|0.373||0.006|2-Sided|95.0|0.3|1.76|||ANCOVA||||
1673207|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.79|Standard Error of the Mean|0.371||0.032|2-Sided|95.0|0.07|1.52|||ANCOVA||||
1673208|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.52|Standard Error of the Mean|0.371||0.16|2-Sided|95.0|-0.21|1.25|||ANCOVA||||
1673209|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.52|Standard Error of the Mean|0.428||0.23|2-Sided|95.0|-0.32|1.36|||ANCOVA||||
1673210|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.34|Standard Error of the Mean|0.369||0.36|2-Sided|95.0|-0.39|1.06|||ANCOVA||||
1673211|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.66|Standard Error of the Mean|0.425||0.12|2-Sided|95.0|-0.18|1.49|||ANCOVA||||
1673212|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.73|Standard Error of the Mean|0.423||0.084|2-Sided|95.0|-0.1|1.56|||ANCOVA||||
1673213|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.17|Standard Error of the Mean|0.428||0.7|2-Sided|95.0|-0.67|1.01|||ANCOVA||||
1673214|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.94|Standard Error of the Mean|0.368||0.011|2-Sided|95.0|0.22|1.66|||ANCOVA||||
1673215|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.73|Standard Error of the Mean|0.371||0.049|2-Sided|95.0|0.0|1.46|||ANCOVA||||
1673216|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.46|Standard Error of the Mean|0.308||0.13|2-Sided|95.0|-0.14|1.07|||ANCOVA||||
1673217|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.69|Standard Error of the Mean|0.313||0.027|2-Sided|95.0|0.08|1.3|||ANCOVA||||
1673218|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.46|Standard Error of the Mean|0.308||0.14|2-Sided|95.0|-0.15|1.06|||ANCOVA||||
1673219|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.18|Standard Error of the Mean|0.31||0.56|2-Sided|95.0|-0.43|0.79|||ANCOVA||||
1673220|NCT01340027|3078417|Superiority or Other (legacy)||LS Mean Difference|0.18|Standard Error of the Mean|0.376||0.63|2-Sided|95.0|-0.56|0.92|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."|
1673221|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.67||||0.21|2-Sided|95.0|0.74|3.75|||Regression, Logistic||||
1673222|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.59||||0.25|2-Sided|95.0|0.72|3.47|||Regression, Logistic||||
1673223|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|2.45||||0.012|2-Sided|95.0|1.22|4.94|||Regression, Logistic||||
1673231|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|0.5||||0.064|2-Sided|95.0|0.24|1.04|||Regression, Logistic||||
1673232|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.51||||0.27|2-Sided|95.0|0.72|3.14|||Regression, Logistic||||
1673233|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.43||||0.32|2-Sided|95.0|0.7|2.9|||Regression, Logistic||||
1673234|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|2.21||||0.012|2-Sided|95.0|1.19|4.09|||Regression, Logistic||||
1673235|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.41||||0.24|2-Sided|95.0|0.79|2.53|||Regression, Logistic||||
1673236|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.25||||0.45|2-Sided|95.0|0.7|2.23|||Regression, Logistic||||
1673237|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.01||||0.98|2-Sided|95.0|0.58|1.77|||Regression, Logistic||||
1673238|NCT01340027|3078425|Superiority or Other (legacy)||Odds Ratio (OR)|1.04||||0.92|2-Sided|95.0|0.52|2.08|||Regression, Logistic|||"All statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."|
1673239|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|4.5|Standard Error of the Mean|2.88||0.12|2-Sided|95.0|-1.2|10.1|||ANCOVA||||
1673240|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|5.9|Standard Error of the Mean|2.88||0.041|2-Sided|95.0|0.2|11.5|||ANCOVA||||
1673241|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|5.6|Standard Error of the Mean|2.52||0.025|2-Sided|95.0|0.7|10.6|||ANCOVA||||
1673242|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|4.7|Standard Error of the Mean|2.54||0.062|2-Sided|95.0|-0.2|9.7|||ANCOVA||||
1673243|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|4.0|Standard Error of the Mean|2.52||0.11|2-Sided|95.0|-0.9|9.0|||ANCOVA||||
1673244|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|1.1|Standard Error of the Mean|2.52||0.67|2-Sided|95.0|-3.9|6.0|||ANCOVA||||
1673245|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|2.1|Standard Error of the Mean|2.91||0.47|2-Sided|95.0|-3.6|7.8|||ANCOVA||||
1673246|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|-0.8|Standard Error of the Mean|2.51||0.76|2-Sided|95.0|-5.7|4.1|||ANCOVA||||
1673247|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|3.3|Standard Error of the Mean|2.88||0.25|2-Sided|95.0|-2.4|8.9|||ANCOVA||||
1673248|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|1.3|Standard Error of the Mean|2.89||0.65|2-Sided|95.0|-4.4|7.0|||ANCOVA||||
1673249|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|-2.0|Standard Error of the Mean|2.9||0.5|2-Sided|95.0|-7.7|3.7|||ANCOVA||||
1673250|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|5.3|Standard Error of the Mean|2.52||0.037|2-Sided|95.0|0.3|10.2|||ANCOVA||||
1673251|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|6.7|Standard Error of the Mean|2.52||0.008|2-Sided|95.0|1.7|11.6|||ANCOVA||||
1673252|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|6.4|Standard Error of the Mean|2.09||0.002|2-Sided|95.0|2.3|10.5|||ANCOVA||||
1673253|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|5.5|Standard Error of the Mean|2.12||0.01|2-Sided|95.0|1.3|9.7|||ANCOVA||||
1673254|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Differrence|4.8|Standard Error of the Mean|2.1||0.022|2-Sided|95.0|0.7|8.9|||ANCOVA||||
1673255|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|1.8|Standard Error of the Mean|2.1||0.38|2-Sided|95.0|-2.3|6.0|||ANCOVA||||
1673256|NCT01340027|3078426|Superiority or Other (legacy)||LS Mean Difference|2.9|Standard Error of the Mean|2.55||0.26|2-Sided|95.0|-2.1|7.9|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."|
1673257|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|1.43||||0.39|2-Sided|95.0|0.63|3.26|||Regression, Logistic||||
1673258|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|2.43||||0.053|2-Sided|95.0|0.99|5.97|||Regression, Logistic||||
1673259|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|2.61||||0.013|2-Sided|95.0|1.22|5.58|||Regression, Logistic||||
1673260|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|2.14||||0.043|2-Sided|95.0|1.02|4.48|||Regression, Logistic||||
1673261|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|1.9||||0.084|2-Sided|95.0|0.92|3.92|||Regression, Logistic||||
1673262|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|1.64||||0.17|2-Sided|95.0|0.81|3.33|||Regression, Logistic||||
1673263|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|2.24||||0.07|2-Sided|95.0|0.94|5.34|||Regression, Logistic||||
1673264|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|1.57||||0.2|2-Sided|95.0|0.78|3.16|||Regression, Logistic||||
1673265|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|1.97||||0.13|2-Sided|95.0|0.83|4.71|||Regression, Logistic||||
1673266|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|1.25||||0.59|2-Sided|95.0|0.56|2.77|||Regression, Logistic||||
1673267|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|1.75||||0.19|2-Sided|95.0|0.75|4.08|||Regression, Logistic||||
1673268|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|0.91||||0.81|2-Sided|95.0|0.42|1.95|||Regression, Logistic||||
1673269|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|1.55||||0.31|2-Sided|95.0|0.67|3.59|||Regression, Logistic||||
1673270|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|1.66||||0.15|2-Sided|95.0|0.83|3.32|||Regression, Logistic||||
1673271|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|1.36||||0.36|2-Sided|95.0|0.7|2.66|||Regression, Logistic||||
1673272|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|1.21||||0.57|2-Sided|95.0|0.63|2.33|||Regression, Logistic||||
1673273|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|1.04||||0.89|2-Sided|95.0|0.55|1.97|||Regression, Logistic||||
1673274|NCT01340027|3078427|Superiority or Other (legacy)||Odds Ratio (OR)|1.42||||0.4|2-Sided|95.0|0.63|3.2|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."|
1673275|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-5.9|Standard Error of the Mean|2.79||0.035|2-Sided|95.0|-11.4|-0.4|||ANCOVA||||
1673276|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-8.0|Standard Error of the Mean|2.78||0.004|2-Sided|95.0|-13.5|-2.6|||ANCOVA||||
1673277|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-8.0|Standard Error of the Mean|2.44||0.001|2-Sided|95.0|-12.8|-3.2|||ANCOVA||||
1673278|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-6.5|Standard Error of the Mean|2.46||0.008|2-Sided|95.0|-11.3|-1.7|||ANCOVA||||
1673279|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-6.1|Standard Error of the Mean|2.44||0.012|2-Sided|95.0|-10.9|-1.3|||ANCOVA||||
1673280|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-2.5|Standard Error of the Mean|2.44||0.31|2-Sided|95.0|-7.3|2.3|||ANCOVA||||
1673281|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-4.4|Standard Error of the Mean|2.81||0.12|2-Sided|95.0|-9.9|1.2|||ANCOVA||||
1673282|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-1.2|Standard Error of the Mean|2.42||0.61|2-Sided|95.0|-6.0|3.5|||ANCOVA||||
1673283|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-4.3|Standard Error of the Mean|0.13||0.13|2-Sided|95.0|-9.8|1.2|||ANCOVA||||
1673284|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-2.0|Standard Error of the Mean|2.8||0.48|2-Sided|95.0|-7.5|3.5|||ANCOVA||||
1673285|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-1.6|Standard Error of the Mean|2.81||0.56|2-Sided|95.0|-7.1|3.9|||ANCOVA||||
1673286|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-4.7|Standard Error of the Mean|2.44||0.056|2-Sided|95.0|-9.4|0.1|||ANCOVA||||
1673287|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-6.8|Standard Error of the Mean|2.43||0.005|2-Sided|95.0|-11.6|-2.0|||ANCOVA||||
1673288|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-6.7|Standard Error of the Mean|2.03|<|0.001|2-Sided|95.0|-10.7|-2.8|||ANCOVA||||
1673289|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-5.2|Standard Error of the Mean|2.05|<|0.011|2-Sided|95.0|-9.3|-1.2|||ANCOVA||||
1673290|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-4.9|Standard Error of the Mean|2.03|<|0.016|2-Sided|95.0|-8.9|-0.9|||ANCOVA||||
1673291|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-1.3|Standard Error of the Mean|2.03|<|0.54|2-Sided|95.0|-5.2|2.7|||ANCOVA||||
1673292|NCT01340027|3078428|Superiority or Other (legacy)||LS Mean Difference|-3.1|Standard Error of the Mean|2.47|<|0.21|2-Sided|95.0|-8.0|1.7|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."|
1673293|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|1.64||||0.5|2-Sided|95.0|0.39|6.85|||Regression, Logistic||||
1673294|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|0.38||||0.4|2-Sided|95.0|0.04|3.66|||Regression, Logistic||||
1673295|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|0.23||||0.11|2-Sided|95.0|0.04|1.4|||Regression, Logistic||||
1673296|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|0.44||||0.28|2-Sided|95.0|0.1|1.96|||Regression, Logistic||||
1673297|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|0.57||||0.46|2-Sided|95.0|0.12|2.59|||Regression, Logistic||||
1673298|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|0.79||||0.74|2-Sided|95.0|0.2|3.13|||Regression, Logistic||||
1673299|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|0.42||||0.37|2-Sided|95.0|0.06|2.79|||Regression, Logistic||||
1673300|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|1.06||||0.93|2-Sided|95.0|0.28|3.95|||Regression, Logistic||||
1673301|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|0.62||||0.57|2-Sided|95.0|0.12|3.3|||Regression, Logistic||||
1673302|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|1.04||||0.96|2-Sided|95.0|0.24|4.59|||Regression, Logistic||||
1673303|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|1.01||||0.99|2-Sided|95.0|0.19|5.36|||Regression, Logistic||||
1673304|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|1.55||||0.51|2-Sided|95.0|0.42|5.71|||Regression, Logistic||||
1673305|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|0.36||||0.36|2-Sided|95.0|0.04|3.2|||Regression, Logistic||||
1673306|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|0.22||||0.082|2-Sided|95.0|0.04|1.22|||Regression, Logistic||||
1673307|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|0.41||||0.22|2-Sided|95.0|0.1|1.67|||Regression, Logistic||||
1673308|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|0.54||||0.39|2-Sided|95.0|0.13|2.19|||Regression, Logistic||||
1673309|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|0.75||||0.65|2-Sided|95.0|0.21|2.61|||Regression, Logistic||||
1673310|NCT01340027|3078429|Superiority or Other (legacy)||Odds Ratio (OR)|0.4||||0.32|2-Sided|95.0|0.06|2.43|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."|
1673311|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.37||||0.36|2-Sided|95.0|0.7|2.67|||Regression, Logistic||||
1673312|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.72||||0.12|2-Sided|95.0|0.87|3.39|||Regression, Logistic||||
1673313|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.87||||0.038|2-Sided|95.0|1.04|3.38|||Regression, Logistic||||
1673314|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.8||||0.054|2-Sided|95.0|0.99|3.28|||Regression, Logistic||||
1673315|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.48||||0.19|2-Sided|95.0|0.82|2.67|||Regression, Logistic||||
1673316|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.33||||0.35|2-Sided|95.0|0.73|2.4|||Regression, Logistic||||
1673317|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.16||||0.66|2-Sided|95.0|0.59|2.31|||Regression, Logistic||||
1673318|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.0||||1|2-Sided|95.0|0.55|1.8|||Regression, Logistic||||
1673319|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.16||||0.67|2-Sided|95.0|0.59|2.28|||Regression, Logistic||||
1673320|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|0.91||||0.8|2-Sided|95.0|0.46|1.81|||Regression, Logistic||||
1673321|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|0.98||||0.94|2-Sided|95.0|0.49|1.93|||Regression, Logistic||||
1673322|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.37||||0.29|2-Sided|95.0|0.77|2.44|||Regression, Logistic||||
1673323|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.72||||0.072|2-Sided|95.0|0.95|3.1|||Regression, Logistic||||
1673324|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.87||||0.012|2-Sided|95.0|1.15|3.05|||Regression, Logistic||||
1673325|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.81||||0.02|2-Sided|95.0|1.1|2.97|||Regression, Logistic||||
1673326|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.48||||0.11|2-Sided|95.0|0.91|2.41|||Regression, Logistic||||
1673327|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.33||||0.25|2-Sided|95.0|0.82|2.17|||Regression, Logistic||||
1673328|NCT01340027|3078430|Superiority or Other (legacy)||Odds Ratio (OR)|1.16||||0.62|2-Sided|95.0|0.64|2.12|||Regression, Logistic||||
1673329|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|1.17||||0.68|2-Sided|95.0|0.55|2.49|||Regression, Logistic||||
1673330|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|1.71||||0.2|2-Sided|95.0|0.76|3.84|||Regression, Logistic||||
1673331|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|2.11||||0.034|2-Sided|95.0|1.06|4.19|||Regression, Logistic||||
1673332|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|1.51||||0.23|2-Sided|95.0|0.77|2.98|||Regression, Logistic||||
1673333|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|1.9||||0.07|2-Sided|95.0|0.95|3.78|||Regression, Logistic||||
1673334|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|1.15||||0.67|2-Sided|95.0|0.6|2.22|||Regression, Logistic||||
1673335|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|2.36||||0.048|2-Sided|95.0|1.01|5.55|||Regression, Logistic||||
1673336|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|1.04||||0.9|2-Sided|95.0|0.55|1.99|||Regression, Logistic||||
1673337|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|0.86||||0.69|2-Sided|95.0|0.41|1.79|||Regression, Logistic||||
1673338|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|1.67||||0.19|2-Sided|95.0|0.77|3.64|||Regression, Logistic||||
1673339|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|1.25||||0.57|2-Sided|95.0|0.58|2.71|||Regression, Logistic||||
1673340|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|1.12||||0.74|2-Sided|95.0|0.57|2.19|||Regression, Logistic||||
1673341|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|1.64||||0.19|2-Sided|95.0|0.79|3.4|||Regression, Logistic||||
1673342|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|2.02||||0.021|2-Sided|95.0|1.11|3.66|||Regression, Logistic||||
1673343|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|1.45||||0.21|2-Sided|95.0|0.81|2.59|||Regression, Logistic||||
1673344|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|1.82||||0.05|2-Sided|95.0|1.0|3.3|||Regression, Logistic||||
1673345|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|1.1||||0.73|2-Sided|95.0|0.63|1.92|||Regression, Logistic||||
1673346|NCT01340027|3078431|Superiority or Other (legacy)||Odds Ratio (OR)|2.26||||0.04|2-Sided|95.0|1.04|4.95|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."|
1673347|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.2|Standard Error of the Mean|0.19||0.26|2-Sided|95.0|-0.6|0.2|||ANCOVA||||
1673348|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.5|Standard Error of the Mean|0.19||0.017|2-Sided|95.0|-0.8|-0.1|||ANCOVA||||
1673349|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.4|Standard Error of the Mean|0.17||0.02|2-Sided|95.0|-0.7|-0.1|||ANCOVA||||
1673350|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.4|Standard Error of the Mean|0.17||0.03|2-Sided|95.0|-0.7|0.0|||ANCOVA||||
1673351|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.3|Standard Error of the Mean|0.17||0.084|2-Sided|95.0|-0.6|0.0|||ANCOVA||||
1673352|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|0.0|Standard Error of the Mean|0.17||1|2-Sided|95.0|-0.3|0.3|||ANCOVA||||
1673353|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.1|Standard Error of the Mean|0.2||0.53|2-Sided|95.0|-0.5|0.3|||ANCOVA||||
1673354|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|0.0|Standard Error of the Mean|0.17||0.88|2-Sided|95.0|-0.3|0.4|||ANCOVA||||
1673355|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.1|Standard Error of the Mean|0.19||0.44|2-Sided|95.0|-0.5|0.2|||ANCOVA||||
1673356|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.1|Standard Error of the Mean|0.19||0.67|2-Sided|95.0|-0.5|0.3|||ANCOVA||||
1673357|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|0.0|Standard Error of the Mean|0.2||0.99|2-Sided|95.0|-0.4|0.4|||ANCOVA||||
1673358|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.2|Standard Error of the Mean|0.17||0.15|2-Sided|95.0|-0.6|0.1|||ANCOVA||||
1673359|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.5|Standard Error of the Mean|0.17||0.004|2-Sided|95.0|-0.8|-0.2|||ANCOVA||||
1673360|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.4|Standard Error of the Mean|0.14||0.003|2-Sided|95.0|-0.7|-0.1|||ANCOVA||||
1673361|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.4|Standard Error of the Mean|0.14||0.005|2-Sided|95.0|-0.7|-0.1|||ANCOVA||||
1673362|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.3|Standard Error of the Mean|0.14||0.024|2-Sided|95.0|-0.6|0.0|||ANCOVA||||
1673363|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|0.0|Standard Error of the Mean|0.14||0.85|2-Sided|95.0|-0.3|0.3|||ANCOVA||||
1673364|NCT01340027|3078432|Superiority or Other (legacy)||LS Mean Difference|-0.1|Standard Error of the Mean|0.17||0.38|2-Sided|95.0|-0.5|0.2|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."|
1673365|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.22|Standard Error of the Mean|0.199||0.26|2-Sided|95.0|-0.62|0.17|||ANCOVA||||
1673366|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.21|Standard Error of the Mean|0.2||0.3|2-Sided|95.0|-0.6|0.18|||ANCOVA||||
1673367|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.3|Standard Error of the Mean|0.173||0.08|2-Sided|95.0|-0.64|0.04|||ANCOVA||||
1673368|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.04|Standard Error of the Mean|0.175||0.84|2-Sided|95.0|-0.38|0.31|||ANCOVA||||
1673369|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.04|Standard Error of the Mean|0.175||0.82|2-Sided|95.0|-0.38|0.3|||ANCOVA||||
1673370|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|0.0|Standard Error of the Mean|0.174||0.99|2-Sided|95.0|-0.34|0.34|||ANCOVA||||
1673371|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.21|Standard Error of the Mean|0.201||0.3|2-Sided|95.0|-0.6|0.18|||ANCOVA||||
1673372|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|0.04|Standard Error of the Mean|0.81||0.81|2-Sided|95.0|-0.3|0.38|||ANCOVA||||
1673373|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|0.06|Standard Error of the Mean|0.2||0.77|2-Sided|95.0|-0.33|0.45|||ANCOVA||||
1673374|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.08|Standard Error of the Mean|0.199||0.67|2-Sided|95.0|-0.48|0.31|||ANCOVA||||
1673375|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|0.05|Standard Error of the Mean|0.201||0.81|2-Sided|95.0|-0.35|0.44|||ANCOVA||||
1673376|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.27|Standard Error of the Mean|0.175||0.13|2-Sided|95.0|-0.61|0.08|||ANCOVA||||
1673377|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.25|Standard Error of the Mean|0.176||0.16|2-Sided|95.0|-0.6|0.1|||ANCOVA||||
1673378|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.35|Standard Error of the Mean|0.145||0.017|2-Sided|95.0|-0.63|-0.06|||ANCOVA||||
1673379|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.08|Standard Error of the Mean|0.147||0.6|2-Sided|95.0|-0.37|0.21|||ANCOVA||||
1673380|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.08|Standard Error of the Mean|0.146||0.58|2-Sided|95.0|-0.37|0.21|||ANCOVA||||
1673381|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.04|Standard Error of the Mean|0.146||0.78|2-Sided|95.0|-0.33|0.25|||ANCOVA||||
1673382|NCT01340027|3078433|Superiority or Other (legacy)||LS Mean Difference|-0.25|Standard Error of the Mean|0.177||0.15|2-Sided|95.0|-0.6|0.09|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."|
1673383|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-1.0|Standard Error of the Mean|0.348||0.004|2-Sided|95.0|-1.68|-0.31|||ANCOVA||||
1673384|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-0.96|Standard Error of the Mean|0.32||0.003|2-Sided|95.0|-1.59|-0.33|||ANCOVA||||
1673385|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-1.0|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-1.59|-0.41|||ANCOVA||||
1674845|NCT01322945|3080720|Superiority or Other|||||||0.001|||||||t-test, 2 sided||||
1673386|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-0.82|Standard Error of the Mean|0.301|<|0.006|2-Sided|95.0|-1.41|-0.23|||ANCOVA||||
1673387|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-0.75|Standard Error of the Mean|0.308|<|0.015|2-Sided|95.0|-1.35|-0.14|||ANCOVA||||
1673388|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-0.4|Standard Error of the Mean|0.301|<|0.18|2-Sided|95.0|-1.0|0.19|||ANCOVA||||
1673389|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-1.1|Standard Error of the Mean|0.377|<|0.004|2-Sided|95.0|-1.84|-0.36|||ANCOVA||||
1673390|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-0.75|Standard Error of the Mean|0.293|<|0.011|2-Sided|95.0|-1.33|-0.18|||ANCOVA||||
1673391|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-0.81|Standard Error of the Mean|0.348|<|0.02|2-Sided|95.0|-1.49|-0.13|||ANCOVA||||
1673392|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-0.31|Standard Error of the Mean|0.34|<|0.36|2-Sided|95.0|-0.98|0.36|||ANCOVA||||
1673393|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-0.4|Standard Error of the Mean|0.343|<|0.24|2-Sided|95.0|-1.08|0.27|||ANCOVA||||
1673394|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-0.25|Standard Error of the Mean|0.296|<|0.4|2-Sided|95.0|-0.83|0.33|||ANCOVA||||
1673395|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-0.21|Standard Error of the Mean|0.262|<|0.43|2-Sided|95.0|-0.72|0.31|||ANCOVA||||
1673396|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-0.25|Standard Error of the Mean|0.238|<|0.3|2-Sided|95.0|-0.71|0.22|||ANCOVA||||
1673397|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-0.07|Standard Error of the Mean|0.239|<|0.76|2-Sided|95.0|-0.54|0.4|||ANCOVA||||
1673398|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|0.0|Standard Error of the Mean|0.248|<|0.99|2-Sided|95.0|-0.48|0.49|||ANCOVA||||
1673399|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|0.35|Standard Error of the Mean|0.239|<|0.15|2-Sided|95.0|-0.12|0.82|||ANCOVA||||
1673400|NCT01340027|3078434|Superiority or Other (legacy)||LS Mean Difference|-0.35|Standard Error of the Mean|0.33|<|0.29|2-Sided|95.0|-0.99|0.3|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."|
1673401|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|-0.01|Standard Error of the Mean|0.088||0.94|2-Sided|95.0|-0.18|0.17|||ANCOVA||||
1673402|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|-0.13|Standard Error of the Mean|0.089||0.15|2-Sided|95.0|-0.3|0.05|||ANCOVA||||
1673403|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|-0.09|Standard Deviation|0.077||0.23|2-Sided|95.0|-0.25|0.06|||ANCOVA||||
1673404|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|-0.02|Standard Error of the Mean|0.078||0.76|2-Sided|95.0|-0.18|0.13|||ANCOVA||||
1673405|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|-0.04|Standard Error of the Mean|0.078||0.58|2-Sided|95.0|-0.2|0.11|||ANCOVA||||
1673406|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|0.04|Standard Error of the Mean|0.078||0.61|2-Sided|95.0|-0.11|0.19|||ANCOVA||||
1673407|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|-0.01|Standard Error of the Mean|0.09||0.88|2-Sided|95.0|-0.19|0.16|||ANCOVA||||
1673408|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|0.13|Standard Error of the Mean|0.077||0.086|2-Sided|95.0|-0.02|0.29|||ANCOVA||||
1673409|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|0.01|Standard Error of the Mean|0.089||0.89|2-Sided|95.0|-0.16|0.19|||ANCOVA||||
1673410|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|0.05|Standard Error of the Mean|0.089||0.57|2-Sided|95.0|-0.12|0.23|||ANCOVA||||
1673411|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|0.13|Standard Error of the Mean|0.09||0.15|2-Sided|95.0|-0.05|0.31|||ANCOVA||||
1673412|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|-0.14|Standard Error of the Mean|0.077||0.07|2-Sided|95.0|-0.29|0.01|||ANCOVA||||
1673413|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|-0.26|Standard Error of the Mean|0.078|<|0.001|2-Sided|95.0|-0.41|-0.11|||ANCOVA||||
1673414|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|-0.23|Standard Error of the Mean|0.065|<|0.001|2-Sided|95.0|-0.35|-0.1|||ANCOVA||||
1673415|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|-0.16|Standard Error of the Mean|0.066|<|0.017|2-Sided|95.0|-0.29|-0.03|||ANCOVA||||
1673416|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|-0.18|Standard Error of the Mean|0.065|<|0.007|2-Sided|95.0|-0.3|-0.05|||ANCOVA||||
1673417|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|-0.09|Standard Error of the Mean|0.065|<|0.15|2-Sided|95.0|-0.22|0.03|||ANCOVA||||
1673418|NCT01340027|3078435|Superiority or Other (legacy)||LS Mean Difference|-0.15|Standard Error of the Mean|0.079|<|0.062|2-Sided|95.0|-0.3|0.01|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."|
1673419|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-0.39|Standard Error of the Mean|0.464||0.4|2-Sided|95.0|-1.3|0.52|||ANCOVA||||
1673420|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-0.18|Standard Error of the Mean|0.467||0.7|2-Sided|95.0|-1.1|0.73|||ANCOVA||||
1673421|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-0.57|Standard Error of the Mean|0.406||0.16|2-Sided|95.0|-1.37|0.23|||ANCOVA||||
1673422|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-0.33|Standard Error of the Mean|0.41||0.42|2-Sided|95.0|-1.14|0.47|||ANCOVA||||
1673423|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-0.44|Standard Error of the Mean|0.408||0.28|2-Sided|95.0|-1.24|0.36|||ANCOVA||||
1673424|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|0.32|Standard Error of the Mean|0.407||0.44|2-Sided|95.0|-0.48|1.12|||ANCOVA||||
1673425|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-0.46|Standard Error of the Mean|0.469||0.33|2-Sided|95.0|-1.38|0.46|||ANCOVA||||
1673426|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|0.8|Standard Error of the Mean|0.406||0.05|2-Sided|95.0|0.0|1.59|||ANCOVA||||
1673427|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-0.09|Standard Error of the Mean|0.468||0.84|2-Sided|95.0|-1.01|0.83|||ANCOVA||||
1673428|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|0.09|Standard Error of the Mean|0.468||0.85|2-Sided|95.0|-0.83|1.01|||ANCOVA||||
1673429|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|0.29|Standard Error of the Mean|0.469||0.53|2-Sided|95.0|-0.63|1.22|||ANCOVA||||
1673430|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-1.18|Standard Error of the Mean|0.405||0.004|2-Sided|95.0|-1.98|-0.39|||ANCOVA||||
1673431|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-0.98|Standard Error of the Mean|0.409||0.017|2-Sided|95.0|-1.78|-0.18|||ANCOVA||||
1673432|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-1.37|Standard Error of the Mean|0.338|<|0.001|2-Sided|95.0|-2.03|-0.7|||ANCOVA||||
1673433|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-1.13|Standard Error of the Mean|0.343|<|0.001|2-Sided|95.0|-1.8|-0.46|||ANCOVA||||
1673434|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-1.24|Standard Error of the Mean|0.34|<|0.001|2-Sided|95.0|-1.91|-0.57|||ANCOVA||||
1673435|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-0.48|Standard Error of the Mean|0.34|<|0.16|2-Sided|95.0|-1.15|0.19|||ANCOVA||||
1673436|NCT01340027|3078436|Superiority or Other (legacy)||LS Mean Difference|-1.26|Standard Error of the Mean|0.412|<|0.002|2-Sided|95.0|-2.06|-0.45|||ANCOVA|||"All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."|
1673437|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|-0.08|Standard Error of the Mean|0.541||0.92|2-Sided|95.0|-1.15|0.98|||Stratified Rank ANCOVA||||
1673438|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|0.58|Standard Error of the Mean|0.516||0.72|2-Sided|95.0|-0.43|1.6|||Stratified Rank ANCOVA||||
1673439|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|-0.22|Standard Error of the Mean|0.517||0.21|2-Sided|95.0|-1.24|0.8|||Stratified Rank ANCOVA||||
1673440|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|-0.34|Standard Error of the Mean|0.499||0.18|2-Sided|95.0|-1.32|0.65|||Stratified Rank ANCOVA||||
1673441|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|-0.01|Standard Error of the Mean|0.49||0.95|2-Sided|95.0|-0.97|0.96|||Stratified Rank ANCOVA||||
1673442|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|0.05|Standard Error of the Mean|0.5||0.46|2-Sided|95.0|-0.93|1.04|||Stratified Rank ANCOVA||||
1673443|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|-0.27|Standard Error of the Mean|0.593||0.58|2-Sided|95.0|-1.44|0.9|||Stratified Rank ANCOVA||||
1673444|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|0.0|Standard Error of the Mean|0.487||0.82|2-Sided|95.0|-0.96|0.96|||Stratified Rank ANCOVA||||
1673445|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|-0.31|Standard Error of the Mean|0.57||0.89|2-Sided|95.0|-1.43|0.82|||Stratified Rank ANCOVA||||
1673446|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|-0.02|Standard Error of the Mean|0.552||0.74|2-Sided|95.0|-1.11|1.07|||Stratified Rank ANCOVA||||
1673447|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|0.06|Standard Error of the Mean|0.59||0.95|2-Sided|95.0|-1.1|1.22|||Stratified Rank ANCOVA||||
1673448|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|-0.08|Standard Error of the Mean|0.435||0.54|2-Sided|95.0|-0.94|0.78|||Stratified Rank ANCOVA||||
1673449|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|0.58|Standard Error of the Mean|0.405||0.24|2-Sided|95.0|-0.21|1.38|||Stratified Rank ANCOVA||||
1673450|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|-0.22|Standard Error of the Mean|0.413||0.12|2-Sided|95.0|-1.04|0.59|||Stratified Rank ANCOVA||||
1673451|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|-0.34|Standard Error of the Mean|0.377||0.003|2-Sided|95.0|-1.08|0.41|||Stratified Rank ANCOVA||||
1673452|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|-0.01|Standard Error of the Mean|0.371||1|2-Sided|95.0|-0.74|0.72|||Stratified Rank ANCOVA||||
1673453|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|0.05|Standard Error of the Mean|0.383||0.35|2-Sided|95.0|-0.7|0.81|||Stratified Rank ANCOVA||||
1673454|NCT01340027|3078437|Superiority or Other (legacy)||LS Mean Difference|-0.27|Standard Error of the Mean|0.495||0.25|2-Sided|95.0|-1.24|0.71||All statistical comparisons are for change from Baseline to End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.|Stratified Rank ANCOVA|P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.||The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.|
1673455|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|0.46||||0.55|2-Sided|95.0|0.04|5.77|||Regression, Logistic||||
1674879|NCT01320722|3080834|Superiority|||||||0.7|||||||Repeated Measures Analysis||||
1673456|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|1.49||||0.79|2-Sided|95.0|0.08|26.47|||Regression, Logistic||||
1673457|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|1.56||||0.76|2-Sided|95.0|0.09|27.42|||Regression, Logistic||||
1673458|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|2.0||||0.64|2-Sided|95.0|0.11|35.46|||Regression, Logistic||||
1673459|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|0.17||||0.12|2-Sided|95.0|0.02|1.58|||Regression, Logistic||||
1673460|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|0.12||||0.059|2-Sided|95.0|0.01|1.08|||Regression, Logistic||||
1673461|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|0.1||||0.054|2-Sided|95.0|0.01|1.05|||Regression, Logistic||||
1673462|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|0.16||||0.11|2-Sided|95.0|0.02|1.48|||Regression, Logistic||||
1673463|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|0.46||||0.55|2-Sided|95.0|0.04|5.99|||Regression, Logistic||||
1673464|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|0.18||||0.15|2-Sided|95.0|0.02|1.87|||Regression, Logistic||||
1673465|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|0.1||||0.058|2-Sided|95.0|0.01|1.08|||Regression, Logistic||||
1673466|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|2.79||||0.23|2-Sided|95.0|0.52|14.9|||Regression, Logistic||||
1673467|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|9.03||||0.047|2-Sided|95.0|1.03|79.19|||Regression, Logistic||||
1673468|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|9.48||||0.042|2-Sided|95.0|1.08|83.24|||Regression, Logistic||||
1673469|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|12.16||||0.023|2-Sided|95.0|1.4|105.3|||Regression, Logistic||||
1673470|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|1.05||||0.93|2-Sided|95.0|0.34|3.28|||Regression, Logistic||||
1673471|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|0.74||||0.58|2-Sided|95.0|0.25|2.17|||Regression, Logistic||||
1673472|NCT01340027|3078438|Superiority or Other (legacy)||Odds Ratio (OR)|0.61||||0.48|2-Sided|95.0|0.16|2.38|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."|
1673473|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|0.83||||0.84|2-Sided|95.0|0.15|4.76|||Regression, Logistic||||
1673474|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|1.68||||0.56|2-Sided|95.0|0.29|9.72|||Regression, Logistic||||
1673475|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|2.39||||0.36|2-Sided|95.0|0.37|15.46|||Regression, Logistic||||
1673476|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|2.67||||0.28|2-Sided|95.0|0.44|16.17|||Regression, Logistic||||
1673477|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|0.41||||0.26|2-Sided|95.0|0.09|1.89|||Regression, Logistic||||
1673478|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|0.29||||0.11|2-Sided|95.0|0.06|1.34|||Regression, Logistic||||
1673479|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|0.28||||0.15|2-Sided|95.0|0.05|1.6|||Regression, Logistic||||
1673480|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|0.44||||0.29|2-Sided|95.0|0.09|2.02|||Regression, Logistic||||
1673481|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|1.07||||0.94|2-Sided|95.0|0.17|6.68|||Regression, Logistic||||
1673482|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|0.43||||0.33|2-Sided|95.0|0.08|2.31|||Regression, Logistic||||
1673483|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|0.34||||0.26|2-Sided|95.0|0.05|2.17|||Regression, Logistic||||
1673484|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|1.91||||0.36|2-Sided|95.0|0.48|7.58|||Regression, Logistic||||
1673485|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|3.84||||0.059|2-Sided|95.0|0.95|15.58|||Regression, Logistic||||
1673486|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|5.49||||0.031|2-Sided|95.0|1.17|25.77|||Regression, Logistic||||
1673487|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|6.12||||0.013|2-Sided|95.0|1.47|25.6|||Regression, Logistic||||
1673488|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|0.95||||0.93|2-Sided|95.0|0.32|2.81|||Regression, Logistic||||
1673489|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|0.67||||0.48|2-Sided|95.0|0.23|1.99|||Regression, Logistic||||
1673490|NCT01340027|3078439|Superiority or Other (legacy)||Odds Ratio (OR)|0.64||||0.52|2-Sided|95.0|0.16|2.56|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."|
1673491|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|1.74||||0.11|2-Sided|95.0|0.88|3.45|||Regression, Logistic||||
1673492|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|2.33||||0.017|2-Sided|95.0|1.16|4.66|||Regression, Logistic||||
1673493|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|2.16||||0.013|2-Sided|95.0|1.18|3.94|||Regression, Logistic||||
1673494|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|1.15||||0.64|2-Sided|95.0|0.64|2.07|||Regression, Logistic||||
1673495|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|1.25||||0.45|2-Sided|95.0|0.7|2.25|||Regression, Logistic||||
1673496|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|1.36||||0.31|2-Sided|95.0|0.75|2.45|||Regression, Logistic||||
1673497|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|1.45||||0.29|2-Sided|95.0|0.73|2.89|||Regression, Logistic||||
1673498|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|1.13||||0.69|2-Sided|95.0|0.63|2.04|||Regression, Logistic||||
1673499|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|1.49||||0.26|2-Sided|95.0|0.74|2.99|||Regression, Logistic||||
1673500|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|0.88||||0.7|2-Sided|95.0|0.45|1.72|||Regression, Logistic||||
1673501|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|0.89||||0.73|2-Sided|95.0|0.45|1.76|||Regression, Logistic||||
1673502|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|1.54||||0.16|2-Sided|95.0|0.84|2.84|||Regression, Logistic||||
1673503|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|2.06||||0.023|2-Sided|95.0|1.11|3.84|||Regression, Logistic||||
1673504|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|1.91||||0.015|2-Sided|95.0|1.14|3.21|||Regression, Logistic||||
1673505|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|1.02||||0.95|2-Sided|95.0|0.61|1.69|||Regression, Logistic||||
1673506|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|1.11||||0.69|2-Sided|95.0|0.67|1.83|||Regression, Logistic||||
1673507|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|1.2||||0.48|2-Sided|95.0|0.72|2.0|||Regression, Logistic||||
1673508|NCT01340027|3078441|Superiority or Other (legacy)||Odds Ratio (OR)|1.29||||0.42|2-Sided|95.0|0.69|2.39|||Regression, Logistic|||"All statistical comparisons are for End of Treatment using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The logistic regression model includes the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate."|
1673509|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|-0.02|Standard Error of the Mean|0.494||0.83|2-Sided|95.0|-0.99|0.95|||Stratified Rank ANCOVA||||
1673510|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|0.68|Standard Error of the Mean|0.475||0.88|2-Sided|95.0|-0.26|1.61|||Stratified Rank ANCOVA||||
1673511|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|-0.19|Standard Error of the Mean|0.472||0.24|2-Sided|95.0|-1.12|0.74|||Stratified Rank ANCOVA||||
1673512|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|-0.27|Standard Error of the Mean|0.454||0.34|2-Sided|95.0|-1.16|0.63|||Stratified Rank ANCOVA||||
1673513|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|0.1|Standard Error of the Mean|0.448||0.62|2-Sided|2.0|-0.78|0.99|||Stratified Rank ANCOVA||||
1673514|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|0.2|Standard Error of the Mean|0.443||0.13|2-Sided|95.0|-0.67|1.07|||Stratified Rank ANCOVA||||
1673515|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|-0.02|Standard Error of the Mean|0.534||0.48|2-Sided|95.0|-1.07|1.03|||Stratified Rank ANCOVA||||
1673516|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|0.07|Standard Error of the Mean|0.444||0.56|2-Sided|95.0|-0.8|0.95|||Stratified Rank ANCOVA||||
1673517|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|-0.31|Standard Error of the Mean|0.533||0.83|2-Sided|95.0|-1.36|0.74|||Stratified Rank ANCOVA||||
1673518|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|0.05|Standard Error of the Mean|0.505||0.85|2-Sided|95.0|-0.95|1.04|||Stratified Rank ANCOVA||||
1673519|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|0.21|Standard Error of the Mean|0.554||0.44|2-Sided|95.0|-0.88|1.3|||Stratified Rank ANCOVA||||
1673520|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|-0.09|Standard Error of the Mean|0.417||0.41|2-Sided|95.0|-0.91|0.73|||Stratified Rank ANCOVA||||
1673521|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|0.6|Standard Error of the Mean|0.395||0.15|2-Sided|95.0|-0.17|1.38|||Stratified Rank ANCOVA||||
1673522|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|-0.26|Standard Error of the Mean|0.397||0.058|2-Sided|95.0|-1.04|0.52|||Stratified Rank ANCOVA||||
1673523|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|-0.34|Standard Error of the Mean|0.365||0.001|2-Sided|95.0|-1.06|0.38||P values were calculated from a pairwise comparison of the combination treatment groups vs solifenacin succinate 5 mg or placebo within the ANCOVA model.|Stratified Rank ANCOVA||||
1673524|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|0.03|Standard Error of the Mean|0.361||0.89|2-Sided|95.0|-0.68|0.74|||Stratified Rank ANCOVA||||
1673525|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|0.13|Standard Error of the Mean|0.355||0.21|2-Sided|95.0|-0.57|0.83|||Stratified Rank ANCOVA||||
1673526|NCT01340027|3078444|Superiority or Other (legacy)||LS Mean Difference|-0.09|Standard Error of the Mean|0.46||0.51|2-Sided|95.0|-1.0|0.82||Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.|Stratified Rank ANCOVA|P-values are from pairwise comparisons of the combination/active treatment groups vs. solifenacin 5 mg/placebo within a stratified rank ANCOVA model.||The ANCOVA model including the 2 main factors mirabegron dose and solifenacin dose and their interaction, sex, age group and geographic region as fixed factors and Baseline measurement as a covariate was used to calculate point estimates and 95% confidence intervals (CI) for change from Baseline within each treatment group and for differences between combination treatment groups and solifenacin 5 mg as well as for differences between active treatment groups and placebo.|
1673527|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-1.08|Standard Error of the Mean|0.412||0.009|2-Sided|95.0|-1.89|-0.28|||ANCOVA||||
1673528|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.98|Standard Error of the Mean|0.414||0.018|2-Sided|95.0|-1.8|-0.17|||ANCOVA||||
1673529|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.91|Standard Error of the Mean|0.361||0.012|2-Sided|95.0|-1.62|-0.2|||ANCOVA||||
1673530|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.12|Standard Error of the Mean|0.364||0.73|2-Sided|95.0|-0.84|0.59|||ANCOVA||||
1673531|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.5|Standard Error of the Mean|0.362||0.17|2-Sided|95.0|-1.21|0.21|||ANCOVA||||
1673532|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.14|Standard Error of the Mean|0.362||0.69|2-Sided|95.0|-0.85|0.57|||ANCOVA||||
1673533|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.79|Standard Error of the Mean|0.417||0.058|2-Sided|95.0|-1.61|0.03|||ANCOVA||||
1673534|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.11|Standard Error of the Mean|0.361||0.77|2-Sided|95.0|-0.82|0.6|||ANCOVA||||
1673535|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.01|Standard Error of the Mean|0.416||0.99|2-Sided|95.0|-0.82|0.81|||ANCOVA||||
1673536|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.13|Standard Error of the Mean|0.415||0.76|2-Sided|95.0|-0.94|0.69|||ANCOVA||||
1673537|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.05|Standard Error of the Mean|0.417||0.91|2-Sided|95.0|-0.87|0.77|||ANCOVA||||
1673538|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.98|Standard Error of the Mean|0.36||0.007|2-Sided|95.0|-1.68|-0.27|||ANCOVA||||
1673539|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.88|Standard Error of the Mean|0.363||0.016|2-Sided|95.0|-1.59|-0.16|||ANCOVA||||
1673540|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.8|Standard Error of the Mean|0.3||0.007|2-Sided|95.0|-1.39|-0.22|||ANCOVA||||
1673541|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.02|Standard Error of the Mean|0.305||0.96|2-Sided|95.0|-0.62|0.58|||ANCOVA||||
1673542|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.39|Standard Error of the Mean|0.302||0.2|2-Sided|95.0|-0.98|0.2|||ANCOVA||||
1673543|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.04|Standard Error of the Mean|0.302||0.91|2-Sided|95.0|-0.63|0.56|||ANCOVA||||
1673544|NCT01340027|3078445|Superiority or Other (legacy)||LS Mean Difference|-0.68|Standard Error of the Mean|0.366||0.062|2-Sided|95.0|-1.4|0.03|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and baseline measurement as a covariate.~LS Mean Differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."|
1673545|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|48.3|Standard Error of the Mean|8.35|<|0.001|2-Sided|95.0|31.9|64.7|||ANCOVA||||
1673546|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|43.6|Standard Error of the Mean|8.42|<|0.001|2-Sided|95.0|27.1|60.1|||ANCOVA||||
1673547|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean DIfference|40.2|Standard Error of the Mean|7.31|<|0.001|2-Sided|95.0|25.8|54.5|||ANCOVA||||
1673548|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|39.6|Standard Error of the Mean|7.39|<|0.001|2-Sided|95.0|25.1|54.1|||ANCOVA||||
1673549|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|27.9|Standard Error of the Mean|7.34|<|0.001|2-Sided|95.0|13.5|42.3|||ANCOVA||||
1673550|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|25.4|Standard Error of the Mean|7.35|<|0.001|2-Sided|95.0|11.0|39.8|||ANCOVA||||
1673551|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|22.2|Standard Error of the Mean|8.46|<|0.009|2-Sided|95.0|5.6|38.8|||ANCOVA||||
1673552|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|22.0|Standard Error of the Mean|7.32|<|0.003|2-Sided|95.0|7.6|36.3|||ANCOVA||||
1673553|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|22.4|Standard Error of the Mean|8.43|<|0.008|2-Sided|95.0|5.9|39.0|||ANCOVA||||
1673554|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|20.5|Standard Error of the Mean|8.43|<|0.015|2-Sided|95.0|4.0|37.1|||ANCOVA||||
1673555|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|11.0|Standard Error of the Mean|8.46|<|0.2|2-Sided|95.0|-5.6|27.6|||ANCOVA||||
1673556|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|26.3|Standard Error of the Mean|7.32|<|0.001|2-Sided|95.0|11.9|40.7|||ANCOVA||||
1673557|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|21.7|Standard Error of the Mean|7.37|<|0.003|2-Sided|95.0|7.2|36.1|||ANCOVA||||
1673558|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|18.2|Standard Error of the Mean|6.1|<|0.003|2-Sided|95.0|6.2|30.2|||ANCOVA||||
1673559|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|17.6|Standard Error of the Mean|6.2|<|0.005|2-Sided|95.0|5.4|29.8|||ANCOVA||||
1673560|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|5.9|Standard Error of the Mean|6.13|<|0.33|2-Sided|95.0|-6.1|18.0|||ANCOVA||||
1673561|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|3.4|Standard Error of the Mean|6.15|<|0.58|2-Sided|95.0|-8.6|15.5|||ANCOVA||||
1673562|NCT01340027|3078446|Superiority or Other (legacy)||LS Mean Difference|0.3|Standard Error of the Mean|7.44|<|0.97|2-Sided|95.0|-14.3|14.9|||ANCOVA|||"Statistical comparisons were made using 2-sided tests at the 0.05 significance level. No adjustment for multiple testing was performed.~The ANCOVA model for all pairwise comparisons includes the 2 main factors mirabegron dose and solifenacin succinate dose and their interaction, sex, age group and geographic region as fixed factors and Baseline value as a covariate.~Least squares (LS) mean differences were calculated by subtracting Solifenacin 5 mg/Placebo from the comparison treatment group."|
1673563|NCT01339923|3078467|Non-Inferiority or Equivalence|Non-inferiority.|Vaccine group difference|0.0|||||2-Sided|95.0|-5.2|7.6||||||Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after booster vaccination for serogroup C.|
1673564|NCT01339923|3078467|Non-Inferiority or Equivalence|Non-inferiority.|Vaccine group difference|-1.0|||||2-Sided|95.0|-6.4|3.9||||||Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ vs MenC-CRM control group at 1 month after 2nd vaccination for serogroup C.|
1673812|NCT01336972|3078751|Superiority or Other||||||<|0.05|||||||paired te-test|||Test to compare Final Treatment versus Baseline for all treatment groups|
1673565|NCT01339910|3078487|Superiority|||||||0.019||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of chronic GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.|
1673566|NCT01339910|3078488|Superiority|||||||0.066||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of grade III-IV acute GVHD during the first 100 days post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of grade III-IV acute GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.|
1673567|NCT01339910|3078488|Superiority|||||||0.024||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of grade II-IV acute GVHD during the first 100 days post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of grade II-IV acute GVHD was compared between treatment arms using Gray's test, treating death as a competing risk.|
1673568|NCT01339910|3078489|Superiority|||||||0.39||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at 18 months post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.|
1673569|NCT01339910|3078489|Superiority|||||||0.011||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at Day 100 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.|
1673570|NCT01339910|3078489|Superiority|||||||0.005||||||Test performed at a significance level of 0.05|Chi-squared|3 degrees of freedom||The null hypothesis is that there is no difference in the proportions of participants with full chimerism, mixed chimerism, graft rejection, and death prior to assessment at Day 28 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens.|
1673571|NCT01339910|3078490|Superiority|||||||0.065||||||Test performed at a significance level of 0.05|Difference in Aalen-Johansen estimators|||The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment at Day 60 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of platelet engraftment at Day 60 was compared between treatment arms using the difference in Aalen-Johansen estimators, which should be close to 0 under the null hypothesis. Death was treated as a competing risk.|
1673572|NCT01339910|3078490|Superiority|||||||0.002||||||Test performed at a significance level of 0.05|Difference in Aalen-Johansen estimators|||The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment at Day 28 post-transplant between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of neutrophil engraftment at Day 28 was compared between treatment arms using the difference in Aalen-Johansen estimators, which should be close to 0 under the null hypothesis. Death was treated as a competing risk.|
1673573|NCT01339910|3078491|Superiority|||||||0.002||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of treatment-related mortality was compared between treatment arms using Gray's test, treating disease relapse as a competing risk.|
1673574|NCT01339910|3078492|Superiority||||||<|0.001||||||Test performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of disease relapse during the first 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. Cumulative incidence of disease relapse was compared between treatment arms using Gray's test, treating death as a competing risk.|
1673575|NCT01339910|3078493|Superiority||Difference in 18 month RFS (MAC-RIC)|20.4|||<|0.01|2-Sided|95.0|8.9|32.0||Test performed at a significance level of 0.05|Difference in Kaplan-Meier estimators|||The null hypothesis is that there is no difference in relapse-free survival at 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. 18 month relapse-free survival was compared between treatment arms using the difference in Kaplan-Meier estimators, which should be close to 0 under the null hypothesis.|
1673576|NCT01339910|3078494|Superiority||Difference in 18 month OS (MAC-RIC)|9.8||||0.07|2-Sided|95.0|-0.8|20.3||This final test was performed at a 0.049 significance level, since 0.001 was spent at interim analyses and the overall significance level was 0.050.|Difference in Kaplan-Meier estimators|||The null hypothesis is that there is no difference in overall survival at 18 months post-randomization between AML/MDS participants receiving MAC and RIC conditioning regimens. 18 month overall survival was compared between treatment arms using the difference in Kaplan-Meier estimators, which should be close to 0 under the null hypothesis.|
1673577|NCT01339858|3078507|Superiority|||||||0.32|||||||ANOVA||||
1673578|NCT01339403|3078527|Superiority or Other||Rate ratio|19.8|||<|0.001|2-Sided|95.0|11.2|35.2|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673579|NCT01339403|3078528|Superiority or Other||Rate ratio|5.6|||<|0.001|2-Sided|95.0|5.3|5.9|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673580|NCT01339403|3078529|Superiority or Other||Rate ratio|8.3|||<|0.001|2-Sided|95.0|7.1|9.6|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673581|NCT01339403|3078530|Superiority or Other||Rate ratio|7.0|||<|0.001|2-Sided|95.0|6.0|8.2|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673813|NCT01336972|3078752|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment|
1673582|NCT01339403|3078531|Superiority or Other||Rate ratio|4.7|||<|0.001|2-Sided|95.0|4.3|5.1|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673583|NCT01339403|3078532|Superiority or Other||Rate ratio|13.0|||<|0.0001|2-Sided|95.0|7.4|23.1|||Poisson Regression|||Histoplasmosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673584|NCT01339403|3078532|Superiority or Other||Rate ratio|6.2|||<|0.001|2-Sided|95.0|3.0|12.9|||Poisson Regression|||Coccidiomycosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673585|NCT01339403|3078532|Superiority or Other||Rate ratio|51.5|||<|0.001|2-Sided|95.0|30.3|87.5|||Poisson Regression|||Toxoplasmosis of brain: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673586|NCT01339403|3078532|Superiority or Other||Rate ratio|10.6|||<|0.001|2-Sided|95.0|7.8|14.4|||Poisson Regression|||Lung Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673587|NCT01339403|3078532|Superiority or Other||Rate ratio|594.5|||<|0.001|2-Sided|95.0|146.5|2411.7|||Poisson Regression|||Progressive multifocal leukoencephalopathy: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673588|NCT01339403|3078532|Superiority or Other||Rate ratio|6.2|||<|0.001|2-Sided|95.0|5.2|7.4|||Poisson Regression|||Mycobacterium tuberculosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673589|NCT01339403|3078532|Superiority or Other||Rate ratio|189.5|||<|0.001|2-Sided|95.0|112.3|319.5|||Poisson Regression|||Cryptococcosis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673590|NCT01339403|3078532|Superiority or Other||Rate ratio|98.4|||<|0.001|2-Sided|95.0|70.8|136.8|||Poisson Regression|||Mycobacterium avium complex: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673591|NCT01339403|3078532|Superiority or Other||Rate ratio|60.2|||<|0.001|2-Sided|95.0|48.3|74.9|||Poisson Regression|||Esophageal Candidiasis: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673592|NCT01339403|3078532|Superiority or Other||Rate ratio|97.1|||<|0.001|2-Sided|95.0|75.5|124.8|||Poisson Regression|||Cytomegalovirus: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673593|NCT01339403|3078532|Superiority or Other||Rate ratio|8.7|||<|0.001|2-Sided|95.0|7.9|9.5|||Poisson Regression|||Pneumonia, recurrent: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673594|NCT01339403|3078532|Superiority or Other||Rate ratio|428.5|||<|0.001|2-Sided|95.0|292.2|628.5|||Poisson Regression|||Pneumocystis jirovecii pneumonia: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673595|NCT01339403|3078532|Superiority or Other||Rate ratio|65.7|||<|0.001|2-Sided|95.0|57.1|75.7|||Poisson Regression|||Wasting syndrome: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673596|NCT01339403|3078533|Superiority or Other||Rate ratio|1.4|||<|0.001|2-Sided|95.0|1.3|1.5|||Poisson Regression|||Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673597|NCT01339403|3078534|Superiority or Other||Rate Ratio|166.1|||<|0.001|2-Sided|95.0|123.4|223.5|||Poisson Regression|||AIDS-defining cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673598|NCT01339403|3078534|Superiority or Other||Rate ratio|1.7|||<|0.001|2-Sided|95.0|1.5|1.8|||Poisson Regression|||Non-AIDS-defining cancers: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673599|NCT01339403|3078534|Superiority or Other||Rate ratio|3.4|||<|0.059|2-Sided|95.0|1.0|12.3|||Poisson Regression|||Invasive cervical cancer: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673600|NCT01339403|3078534|Superiority or Other||Rate ratio|12.1|||<|0.001|2-Sided|95.0|10.3|14.2|||Poisson Regression|||Invasive non-Hodgkin's lymphoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673601|NCT01339403|3078534|Superiority or Other||Rate ratio|166.1|||<|0.001|2-Sided|95.0|123.4|223.5|||Poisson Regression|||Kaposi's sarcoma: Poisson regression models were used to analyze rates of clinical events by HIV and unadjusted incidence rate ratios compared risk in HIV-uninfected persons to HIV-infected persons.|
1673602|NCT01339390|3078535|Superiority or Other||Mean Difference (Final Values)|0.5893|Standard Error of the Mean|0.5759||0.3062|2-Sided|95.0|-0.5395|1.7181||calculated after fitting the data to a repeated measures mixed model to control for repeated subject and random site and group effects|t-test, 2 sided|accounted for repeated measures and random effects|The difference is expressed as the Move (arm 2) group minus the Move Out (arm 1) group|This is the analysis at 24 months, comparing the change in weight from 24 months to baseline in our Move Out (arm 1) vs Move (arm 2) groups|
1674880|NCT01320722|3080834|Superiority|||||||0.6|||||||Repeated Measures Analysis||||
1673603|NCT01339390|3078535|Superiority or Other||Mean Difference (Final Values)|0.3941|Standard Error of the Mean|0.5759||0.4937|2-Sided|95.0|-0.7347|1.5229||calculated after fitting the data to a repeated measures mixed model to control for repeated subject and random site and group effects|t-test, 2 sided|accounted for repeated measures and random effects|The difference is expressed as the Move (arm 2) group minus the Move Out (arm 1) group|This is the analysis at 12 months, comparing the change in weight from 12 months to baseline in our Move Out (arm 1) vs Move (arm 2) groups|
1673604|NCT01339260|3078551|Superiority or Other||Odds Ratio (OR)|1.47||||0.001|2-Sided|95.0|1.17|1.85||If the null hypothesis for CR acute was rejected, analysis of the 2nd key secondary endpoint CR overall was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.||CR in the overall phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the overall phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.|
1673605|NCT01339260|3078552|Superiority or Other||Odds Ratio (OR)|1.37||||0.047|2-Sided|95.0|1.0|1.87||If the null hypothesis for CR delayed was rejected, analysis of the first key secondary endpoint CR acute was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.||CR in the acute phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the acute phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.|
1673606|NCT01339260|3078553|Superiority or Other||Odds Ratio (OR)|1.48||||0.001|2-Sided|95.0|1.16|1.87||If superiority of netupitant/palonosetron was established for the CR delayed, CR acute and then CR overall at cycle 1 were to be tested according to a hierarchical procedure;no adjustment for multiplicity was needed.The a priori threshold was 0.050|Cochran-Mantel-Haenszel||Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.|The null hypothesis was rejected if the 2 sided p value from the Cochran Mantel Haenszel test was less than or equal to 0.050 and in the right direction i.e., the Odds Ratio (OR) was in favor of netupitant/palonosetron. Power was 90%.|
1673607|NCT01339247|3078554|Non-Inferiority or Equivalence|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency – ANVISA – upon a manufacturing site change.|Ratio T formulation/R formulation|1.0317|||||2-Sided|90.0|0.9716|1.0956|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.||
1673608|NCT01339247|3078555|Non-Inferiority or Equivalence|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency – ANVISA – upon a manufacturing site change.|Ratio T formulation/R formulation|1.0246|||||2-Sided|90.0|0.9676|1.0849|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.||
1673609|NCT01339247|3078556|Non-Inferiority or Equivalence|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency – ANVISA – upon a manufacturing site change.|Ratio T formulation/R formulation|1.0886|||||2-Sided|90.0|1.0011|1.177|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.||
1673610|NCT01339091|3078560|Non-Inferiority or Equivalence|The non-inferiority hypothesis test is a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the 95% CI for the difference in response rates in the ITT population is greater than -10% the NI of dalbavancin to vancomycin/linezolid will be concluded.|Difference in Proportions|1.5|||||2-Sided|95.0|-4.6|7.9|||||Confidence intervals were adjusted for fever at baseline||
1673611|NCT01338987|3078584|Other|||||||0.0075|||||||Wilcoxon's rank sum test||||
1673612|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.4|Standard Error of the Mean|0.484||0.4081|2-Sided|95.0|-1.35|0.55|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673613|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.28|Standard Error of the Mean|0.476||0.5501|2-Sided|95.0|-1.22|0.65|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673614|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.21|Standard Error of the Mean|0.492||0.6697|2-Sided|95.0|-1.18|0.76|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673615|NCT01338870|3078588|Superiority or Other||LS mean difference|0.39|Standard Error of the Mean|0.497||0.4349|2-Sided|95.0|-0.59|1.37|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673616|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.4|Standard Error of the Mean|0.504||0.4253|2-Sided|95.0|-1.39|0.59|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673617|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.3|Standard Error of the Mean|0.407||0.46|2-Sided|95.0|-1.1|0.5|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673762|NCT01337167|3078693|Superiority or Other||Mean Difference (Final Values)|6.7|||||2-Sided|95.0|2.4|10.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal >=38.5°C and <39.5°C|
1673618|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.37|Standard Error of the Mean|0.402||0.3599|2-Sided|95.0|-1.16|0.42|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673619|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.23|Standard Error of the Mean|0.413||0.5769|2-Sided|95.0|-1.04|0.58|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673620|NCT01338870|3078588|Superiority or Other||LS mean difference|0.39|Standard Error of the Mean|0.415||0.3447|2-Sided|95.0|-0.42|1.21|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673621|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.24|Standard Error of the Mean|0.421||0.5691|2-Sided|95.0|-1.07|0.59|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673622|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.13|Standard Error of the Mean|0.33||0.6948|2-Sided|95.0|-0.78|0.52|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673623|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.42|Standard Error of the Mean|0.329||0.2031|2-Sided|95.0|-1.07|0.23|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673624|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.13|Standard Error of the Mean|0.335||0.7038|2-Sided|95.0|-0.79|0.53|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673625|NCT01338870|3078588|Superiority or Other||LS mean difference|0.37|Standard Error of the Mean|0.336||0.2772|2-Sided|95.0|-0.3|1.03|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673626|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.39|Standard Error of the Mean|0.339||0.252|2-Sided|95.0|-1.06|0.28|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673627|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.53|Standard Error of the Mean|0.346||0.1279|2-Sided|95.0|-1.21|0.15|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673628|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.3|Standard Error of the Mean|0.345||0.3834|2-Sided|95.0|-0.98|0.38|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673629|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.5|Standard Error of the Mean|0.352||0.1564|2-Sided|95.0|-1.19|0.19|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673630|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.13|Standard Error of the Mean|0.353||0.7107|2-Sided|95.0|-0.83|0.56|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673631|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.71|Standard Error of the Mean|0.357||0.0464|2-Sided|95.0|-1.42|-0.01|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673632|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.3|Standard Error of the Mean|0.269||0.264|2-Sided|95.0|-0.83|0.23|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673633|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.18|Standard Error of the Mean|0.268||0.5104|2-Sided|95.0|-0.7|0.35|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673634|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.15|Standard Error of the Mean|0.272||0.5849|2-Sided|95.0|-0.68|0.39|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673635|NCT01338870|3078588|Superiority or Other||LS mean difference|0.19|Standard Error of the Mean|0.271||0.4889|2-Sided|95.0|-0.35|0.72|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673814|NCT01336972|3078752|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment|
1674881|NCT01320722|3080835|Superiority|||||||0.6|||||||Repeated Measures Analysis||||
1673636|NCT01338870|3078588|Superiority or Other||LS mean difference|-0.16|Standard Error of the Mean|0.272||0.5636|2-Sided|95.0|-0.69|0.38|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673637|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.37|Standard Error of the Mean|0.121||0.0013|2-Sided|80.0|-0.52|-0.21|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673638|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.37|Standard Error of the Mean|0.119||0.0011|2-Sided|80.0|-0.52|-0.21|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673639|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.31|Standard Error of the Mean|0.122||0.0065|2-Sided|80.0|-0.46|-0.15|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673640|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.18|Standard Error of the Mean|0.123||0.0778|2-Sided|80.0|-0.33|-0.02|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673641|NCT01338870|3078590|Superiority or Other||LS mean difference|0.1|Standard Error of the Mean|0.126||0.7854|2-Sided|80.0|-0.06|0.26|||Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673642|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.32|Standard Error of the Mean|0.09||0.0002|2-Sided|80.0|-0.44|-0.21|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673643|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.24|Standard Error of the Mean|0.089||0.0034|2-Sided|80.0|-0.36|-0.13|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673644|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.27|Standard Error of the Mean|0.091||0.0019|2-Sided|80.0|-0.38|-0.15|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673645|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.17|Standard Error of the Mean|0.091||0.0308|2-Sided|80.0|-0.29|-0.05|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673646|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.07|Standard Error of the Mean|0.094||0.2392|2-Sided|80.0|-0.19|0.05|||Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673647|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.22|Standard Error of the Mean|0.069||0.0009|2-Sided|80.0|-0.3|-0.13|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673648|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.18|Standard Error of the Mean|0.068||0.0051|2-Sided|80.0|-0.26|-0.09|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673649|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.11|Standard Error of the Mean|0.069||0.0512|2-Sided|80.0|-0.2|-0.02|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673650|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.11|Standard Error of the Mean|0.069||0.0636|2-Sided|80.0|-0.2|-0.02|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1674090|NCT01333189|3079225|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Internal moment at the ankle|
1673651|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.1|Standard Error of the Mean|0.07||0.0695|2-Sided|80.0|-0.19|-0.01|||Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673652|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.18|Standard Error of the Mean|0.058||0.001|2-Sided|80.0|-0.25|-0.11|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673653|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.06|Standard Error of the Mean|0.057||0.1568|2-Sided|80.0|-0.13|0.02|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673654|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.1|Standard Error of the Mean|0.058||0.04|2-Sided|80.0|-0.18|-0.03|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673655|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.12|Standard Error of the Mean|0.058||0.0234|2-Sided|95.0|-0.19|-0.04|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673656|NCT01338870|3078590|Superiority or Other||LS mean difference|-0.05|Standard Error of the Mean|0.058||0.1797|2-Sided|80.0|-0.13|0.02|||Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673657|NCT01338870|3078591|Superiority or Other||LS mean difference|-14.95|Standard Error of the Mean|5.981||0.0126|2-Sided|95.0|-26.69|-3.21|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673658|NCT01338870|3078591|Superiority or Other||LS mean difference|-15.3|Standard Error of the Mean|5.918||0.0099|2-Sided|95.0|-26.91|-3.68|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673659|NCT01338870|3078591|Superiority or Other||LS mean difference|4.7|Standard Error of the Mean|6.103||0.4413|2-Sided|95.0|-7.28|16.68|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673660|NCT01338870|3078591|Superiority or Other||LS mean difference|-9.71|Standard Error of the Mean|6.17||0.1159|2-Sided|95.0|-21.82|2.4|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673661|NCT01338870|3078591|Superiority or Other||LS mean difference|6.5|Standard Error of the Mean|6.217||0.2963|2-Sided|95.0|-5.71|18.7|||Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673662|NCT01338870|3078591|Superiority or Other||LS mean difference|-18.62|Standard Error of the Mean|5.875||0.0016|2-Sided|95.0|-30.15|-7.09|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673663|NCT01338870|3078591|Superiority or Other||LS mean difference|-15.3|Standard Error of the Mean|5.853||0.0091|2-Sided|95.0|-26.79|-3.81|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673664|NCT01338870|3078591|Superiority or Other||LS mean difference|0.71|Standard Error of the Mean|5.971||0.9053|2-Sided|95.0|-11.01|12.43|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673665|NCT01338870|3078591|Superiority or Other||LS mean difference|-7.56|Standard Error of the Mean|6.004||0.2084|2-Sided|95.0|-19.34|4.23|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673666|NCT01338870|3078591|Superiority or Other||LS mean difference|6.99|Standard Error of the Mean|6.055||0.2488|2-Sided|95.0|-4.9|18.87|||Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673667|NCT01338870|3078591|Superiority or Other||LS mean difference|-19.08|Standard Error of the Mean|5.696||0.0008|2-Sided|95.0|-30.26|-7.9|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1674882|NCT01320722|3080835|Superiority|||||||0.8|||||||Repeated Measures Analysis||||
1673668|NCT01338870|3078591|Superiority or Other||LS mean difference|-19.57|Standard Error of the Mean|5.707||0.0006|2-Sided|95.0|-30.77|-8.36|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673669|NCT01338870|3078591|Superiority or Other||LS mean difference|0.94|Standard Error of the Mean|5.794||0.8712|2-Sided|95.0|-10.43|12.31|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673670|NCT01338870|3078591|Superiority or Other||LS mean difference|-8.47|Standard Error of the Mean|5.815||0.1455|2-Sided|95.0|-19.89|2.94|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673671|NCT01338870|3078591|Superiority or Other||LS mean difference|3.86|Standard Error of the Mean|5.895||0.5125|2-Sided|95.0|-7.71|15.43|||Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673672|NCT01338870|3078591|Superiority or Other||LS mean difference|-18.69|Standard Error of the Mean|5.735||0.0012|2-Sided|95.0|-29.95|-7.44|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673673|NCT01338870|3078591|Superiority or Other||LS mean difference|-13.88|Standard Error of the Mean|5.744||0.0159|2-Sided|95.0|-25.16|-2.61|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673674|NCT01338870|3078591|Superiority or Other||LS mean difference|-2.87|Standard Error of the Mean|5.816||0.6222|2-Sided|95.0|-14.28|8.55|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673675|NCT01338870|3078591|Superiority or Other||LS mean difference|-4.14|Standard Error of the Mean|5.814||0.4767|2-Sided|95.0|-15.55|7.27|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673676|NCT01338870|3078591|Superiority or Other||LS mean difference|0.08|Standard Error of the Mean|5.852||0.9893|2-Sided|95.0|-11.41|11.56|||Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673677|NCT01338870|3078591|Superiority or Other||LS mean difference|-21.09|Standard Error of the Mean|5.712||0.0002|2-Sided|95.0|-32.3|-9.88|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673678|NCT01338870|3078591|Superiority or Other||LS mean difference|-15.92|Standard Error of the Mean|5.678||0.0052|2-Sided|95.0|-27.06|-4.77|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673679|NCT01338870|3078591|Superiority or Other||LS mean difference|-8.1|Standard Error of the Mean|5.71||0.1566|2-Sided|95.0|-19.3|3.11|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673680|NCT01338870|3078591|Superiority or Other||LS mean difference|-9.45|Standard Error of the Mean|5.686||0.0969|2-Sided|95.0|-20.61|1.71|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673681|NCT01338870|3078591|Superiority or Other||LS mean difference|-5.21|Standard Error of the Mean|5.7||0.3611|2-Sided|95.0|-16.4|5.98|||Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673682|NCT01338870|3078592|Superiority or Other||LS mean difference|-0.43|Standard Error of the Mean|0.139||0.0013|2-Sided|80.0|-0.6|-0.25|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673683|NCT01338870|3078592|Superiority or Other||LS mean difference|-0.53|Standard Error of the Mean|0.137||0.0001|2-Sided|80.0|-0.71|-0.36|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673684|NCT01338870|3078592|Superiority or Other||LS mean difference|-0.24|Standard Error of the Mean|0.141||0.044|2-Sided|80.0|-0.42|-0.06|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673763|NCT01337167|3078693|Superiority or Other||Mean Difference (Final Values)|6.5|||||2-Sided|95.0|1.9|10.8|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal >=38°C and <38.5°C|
1673685|NCT01338870|3078592|Superiority or Other||LS mean difference|-0.28|Standard Error of the Mean|0.142||0.0266|2-Sided|80.0|-0.46|-0.09|||Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673686|NCT01338870|3078592|Superiority or Other||Least squares (LS) mean difference|0.1|Standard Error of the Mean|0.145||0.7606|2-Sided|80.0|-0.08|0.29|||Mixed Models Analysis|||Treatment difference and 80% confidence interval (CI) were based on least squares (LS) mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction, baseline-by-treatment interaction, baseline-by-treatment-by-time interaction as the covariates, time was repeated for participant.|
1673687|NCT01338649|3078604|Superiority or Other|||||||0.0211|||||||t-test, 2 sided|t-test on two groups of differences|||
1673688|NCT01338493|3078620|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1673689|NCT01338493|3078621|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1673690|NCT01338415|3078622|Superiority|||||||0.014|||||||log(e) likelihood ratio|p-value <= 10% indicates an improvement in model fit||Test of the improvement in model fit from the univariate to the multivariate model with WHO FC at baseline as covariate|
1673691|NCT01338415|3078622|Other||Hazard Ratio (HR)|1.487|||||2-Sided|95.0|0.437|5.052||||||Post-hoc analysis: Treatment Hazard Ratio (HR) in the multivariate model with treatment and WHO FC at baseline as covariates|
1673692|NCT01338415|3078622|Other|||||||0.0085|||||||Regression, Cox|p-value <= 10% indicates that the covariate is related to the time to the time to death up to end-of-study||Post-hoc analysis: Cox proportional hazard regression univariate model with WHO FC at baseline (FC III vs FC I/II) as covariate|
1673693|NCT01338415|3078622|Other||Hazard Ratio (HR)|1.935|||||2-Sided|95.0|0.582|6.428||||||Post-hoc analysis: Cox proportional hazard regression univariate model with treatment as covariate (treatment-only univariate model)|
1673694|NCT01338415|3078623|Superiority|||||||0.076||||||p-value <= 10% indicates an improvement in model fit|log(e) likelihood ratio|||Test of improvement in model fit from the univariate to the multivariate model with WHO FC at baseline as covariate|
1673695|NCT01338415|3078623|Other||Hazard Ratio (HR)|1.169||||||95.0|0.371|3.681||||||Post-hoc analysis: Treatment Hazard Ratio (HR) in the multivariate model with treatment and WHO FC at baseline as covariates|
1673696|NCT01338415|3078623|Other|||||||0.0526||||||p-value <= 10% indicates that the covariate WHO FC at baseline is related to the time to PAH worsening|Regression, Cox|||Post-hoc analysis: Cox proportional hazard regression univariate model with WHO FC at baseline (FC III vs FC I/II) as covariate|
1673697|NCT01338415|3078623|Other||Hazard Ratio (HR)|1.438|||||2-Sided|95.0|0.47|4.399||||||Post-hoc analysis: Cox proportional hazard regression univariate model with treatment as covariate (treatment-only univariate model)|
1673698|NCT01338025|3078635|Superiority or Other|||||||0.03|||||||Log Rank||||
1673699|NCT01337986|3078638|Superiority or Other (legacy)|||||||0.72|||||||Regression, Linear||||
1673700|NCT01337986|3078639|Superiority|||||||0.39|||||||Wilcoxon (Mann-Whitney)||||
1673701|NCT01337986|3078640|Superiority or Other (legacy)|||||||0.94|||||||Regression, Logistic||||
1673702|NCT01337986|3078641|Superiority or Other (legacy)||Odds Ratio (OR)|1.46||||0.04|2-Sided|95.0|1.02|2.1||Probability of being in the lowest quartile for Visual Field Index deficits.|Regression, Logistic||Odds Ratio for Visual Field Index||
1673703|NCT01337986|3078643|Superiority or Other (legacy)|||||||0.34|||||||Regression, Logistic||||
1673704|NCT01337986|3078644|Superiority or Other (legacy)|||||||0.93|||||||Regression, Logistic||||
1673705|NCT01337986|3078645|Superiority or Other (legacy)|||||||0.11|||||||Mixed Models Analysis|||Null hypothesis for period effect: there will be no difference in the change relevant to baseline (visit 1) in EDTRS 5% contrast sensitivity for those who started on dalfampridine and crossed over to placebo, compared to those who started on placebo and crossed over to dalfampridine.|
1673706|NCT01337986|3078645|Superiority or Other (legacy)||Mean Difference (Final Values)|0.008|Standard Error of the Mean|0.01||0.64|2-Sided|95.0|||||Mixed Models Analysis|||Null hypothesis: there will be no difference in the change relevant to baseline (visit 1) in EDTRS 5% contrast sensitivity with dalfampridine vs placebo.|
1673707|NCT01337986|3078647|Superiority or Other (legacy)|||||||0.29|||||||Mixed Models Analysis|||Change in EDTRS between Visits 2 and 3.|
1673708|NCT01337986|3078647|Superiority or Other (legacy)|||||||0.84|||||||Mixed Models Analysis|||Per protocol Analysis|
1673709|NCT01337973|3078648|Superiority||||||<|0.05||||||The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.58||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"|
1673710|NCT01337973|3078648|Superiority||||||>|0.05||||||The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -1.5||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"|
1673711|NCT01337973|3078648|Superiority||||||>|0.05||||||The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -1.45||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"|
1673712|NCT01337973|3078648|Superiority||||||<|0.001||||||The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -4.65||"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"|
1673806|NCT01336972|3078751|Superiority or Other||||||>|0.05|||||||Paired t-test|||Test to compare Post Treatment versus Baseline|
1675537|NCT01309360|3082375|Superiority or Other|||||||1|||||||Fisher Exact||||
1673713|NCT01337973|3078648|Superiority||coefficient estimate|0.95|||<|0.001|2-Sided|95.0|0.61|1.48||The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -3.51|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"|
1673714|NCT01337973|3078648|Superiority||coefficient estimate|1.18|||<|0.01|2-Sided|95.0|0.57|2.44||The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.86|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"|
1673715|NCT01337973|3078648|Superiority||coefficient estimate|0.61|||<|0.05|2-Sided|95.0|0.17|2.16||The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.56|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"|
1673716|NCT01337973|3078648|Superiority||coefficient estimate|1.15|||<|0.001|2-Sided|95.0|0.78|1.71||The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -4.94|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"|
1673717|NCT01337973|3078648|Superiority||coefficient estimate|0.84|||<|0.05|2-Sided|95.0|0.54|1.32||The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.48|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to illicit drug use % change from baseline"|
1673718|NCT01337973|3078648|Superiority||coefficient estimate|0.85|||<|0.05|2-Sided|95.0|0.4|1.8||The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.13|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to marijuana use % change from baseline"|
1673719|NCT01337973|3078648|Superiority||coefficient estimate|0.49|||<|0.01|2-Sided|95.0|0.18|1.32||The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -2.98|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to cocaine use % change from baseline"|
1673720|NCT01337973|3078648|Superiority||Coefficient estimate|0.95|||<|0.001|2-Sided|95.0|0.62|1.47||The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.|Wilcoxon Z|Wilcoxon Z value: -3.52|E-TAU arm is the referent group|"Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.~This test applies to heavy drinking % change from baseline"|
1673721|NCT01337973|3078649|Superiority||||||<|0.01||||||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.21||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall non-partner injury % change from baseline|
1673722|NCT01337973|3078649|Superiority||||||<|0.01||||||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z Score: -4.01||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline|
1673723|NCT01337973|3078649|Superiority||||||>|0.05||||||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z Score: -1.02||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline|
1673724|NCT01337973|3078649|Superiority||||||<|0.01||||||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.90||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline|
1673725|NCT01337973|3078649|Superiority||||||<|0.01||||||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.32||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury % change from baseline|
1673726|NCT01337973|3078649|Superiority||||||<|0.001||||||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.69||Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline|
1673727|NCT01337973|3078649|Superiority||Coefficient Estimate|1.09|||<|0.01|2-Sided|95.0|0.4|2.95||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.17|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline|
1673807|NCT01336972|3078751|Superiority or Other||||||>|0.05|||||||paired t-test|||Test to compare Post Treatment versus Baseline|
1673728|NCT01337973|3078649|Superiority||Coefficient Estimate|1.12|||<|0.001|2-Sided|95.0|0.6|2.08||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.10|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline|
1673729|NCT01337973|3078649|Superiority||Coefficient Estimate|0.48|||>|0.05|2-Sided|95.0|0.16|1.47||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -1.81|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline|
1673730|NCT01337973|3078649|Superiority||Coefficient Estimate|0.48|||<|0.01|2-Sided|95.0|0.13|1.78||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.59|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline|
1673731|NCT01337973|3078649|Superiority||Coefficient Estimate|1.05|||<|0.001|2-Sided|95.0|0.45|2.44||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.74|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline|
1673732|NCT01337973|3078649|Superiority||Coefficient Estimate|0.6|||<|0.001|2-Sided|95.0|0.25|1.46||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -4.81|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline|
1673733|NCT01337973|3078649|Superiority||Coefficient Estimate|0.8|||<|0.05|2-Sided|95.0|0.32|1.98||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.01|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline|
1673734|NCT01337973|3078649|Superiority||Coefficient Estimate|1.22|||<|0.001|2-Sided|95.0|0.66|2.28||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.79|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline|
1673735|NCT01337973|3078649|Superiority||Coefficient Estimate|0.51|||<|0.05|2-Sided|95.0|0.19|1.38||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.26|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline|
1673736|NCT01337973|3078649|Superiority||Coefficient Estimate|1.16|||<|0.01|2-Sided|95.0|0.36|3.77||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -3.31|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline|
1673737|NCT01337973|3078649|Superiority||Coefficient Estimate|0.62|||<|0.01|2-Sided|95.0|0.3|1.29||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z score: -2.83|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline|
1673738|NCT01337973|3078649|Superiority||Coefficient estimate|0.82|||<|0.001|2-Sided|95.0|0.37|1.84||The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.|Wilcoxon Z|Wilcoxon Z value: -4.65|E-TAU arm is the referent group|Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline|
1673739|NCT01337960|3078651|Superiority or Other||||||=|0|||||||Fisher Exact||||
1673740|NCT01337960|3078652|Superiority or Other||||||=|0|||||||Fisher Exact||||
1673741|NCT01337960|3078653|Superiority or Other||||||<|0.02|||||||Fisher Exact||||
1673742|NCT01337960|3078654|Superiority or Other||||||<|0.01|||||||Fisher Exact||||
1673743|NCT01337674|3078667|Non-Inferiority or Equivalence|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is <20 mmHg|Mean Difference (Final Values)|-1.57|||||2-Sided|90.0|-6.79|3.65|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 7|
1673744|NCT01337674|3078667|Non-Inferiority or Equivalence|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is <20 mmHg|Mean Difference (Final Values)|-6.25|||||2-Sided|90.0|-11.47|-1.03|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 1|
1673808|NCT01336972|3078751|Superiority or Other||||||<|0.05|||||||paired t-test|||Test to compare Post Treatment versus Baseline|
1673745|NCT01337674|3078667|Non-Inferiority or Equivalence|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is <20 mmHg|Mean Difference (Final Values)|-5.91|||||2-Sided|90.0|-10.71|-1.11|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 7|
1673746|NCT01337674|3078667|Non-Inferiority or Equivalence|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Amlo versus PBO + Amlo is <20 mmHg|Mean Difference (Final Values)|1.95|||||2-Sided|90.0|-2.85|6.75|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 1|
1673747|NCT01337674|3078668|Non-Inferiority or Equivalence|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is <20 mmHg|Mean Difference (Final Values)|-1.09|||||2-Sided|90.0|-8.06|5.88|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 7|
1673748|NCT01337674|3078668|Non-Inferiority or Equivalence|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is <20 mmHg|Mean Difference (Final Values)|1.65|||||2-Sided|90.0|-5.31|8.62|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Standing, Day 1|
1673749|NCT01337674|3078668|Non-Inferiority or Equivalence|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is <20 mmHg|Mean Difference (Final Values)|2.29|||||2-Sided|90.0|-4.92|9.49|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 7|
1673750|NCT01337674|3078668|Non-Inferiority or Equivalence|Hypothesis: the upper bound of the 90% confidence interval for the difference in maximum change from baseline for MK-4618 + Met versus PBO + Met is <20 mmHg|Mean Difference (Final Values)|-1.22|||||2-Sided|90.0|-8.42|5.98|||||The estimated parameter is mean maximum change from baseline for placebo minus MK-4618. Mean and confidence interval for the difference were obtained from linear mixed effects model performed on the maximum increase from baseline values.|Semi-recumbent, Day 1|
1673751|NCT01337336|3078682|Superiority or Other||Incident Rate Ratio|1.16||||0.052||95.0|0.98|1.37||COPD-related hospitalization/ER visit/physician + Rx visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.||
1673752|NCT01337336|3078682|Superiority or Other||Incident Rate Ratio|1.31||||0.009||95.0|1.05|1.72||COPD-related hospitalization/ER visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.||
1673753|NCT01337336|3078682|Superiority or Other||Incident Rate Ratio|1.09||||0.671||95.0|0.9|1.32||COPD-related physician + Rx visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.||
1673754|NCT01337336|3078682|Superiority or Other||Incident Rate Ratio|1.27||||0.208||95.0|0.89|1.82||COPD-related ER visit|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.||
1673755|NCT01337336|3078682|Superiority or Other||Incident Rate Ratio|1.46||||0.0004||95.0|1.01|2.09||COPD-related hospitalization|t-test, 2 sided||Estimated value obtained from zero-inflated negative binomial model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.||
1673756|NCT01337336|3078684|Superiority or Other||Odds Ratio (OR)|1.71|||<|0.001||95.0|1.26|2.31|||Chi-squared|COPD-related hospitalization/ER visit|Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.||
1673757|NCT01337336|3078684|Superiority or Other||Odds Ratio (OR)|1.14|||<|0.503||95.0|0.93|1.4|||Chi-squared|COPD-related physician + Rx visit|Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.||
1673758|NCT01337336|3078684|Superiority or Other||Odds Ratio (OR)|1.65|||<|0.002||95.0|1.14|2.39||COPD-related ER visit|Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.||
1673759|NCT01337336|3078684|Superiority or Other||Odds Ratio (OR)|1.56|||<|0.002||95.0|1.02|2.38||COPD-related hospitalization|Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.||
1673760|NCT01337336|3078685|Superiority or Other||Odds Ratio (OR)|1.3||||0.002||95.0|1.08|1.56|||Chi-squared||Estimated value obtained from logistic regression model controlling for differences between cohorts at baseline on demographic variables, proxy measures of COPD severity, and measures of overall disease burden.||
1673761|NCT01337167|3078693|Superiority or Other||Mean Difference (Final Values)|1.2|||||2-Sided|95.0|-0.3|2.4|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal >=39.5°C|
1673809|NCT01336972|3078751|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment|
1673764|NCT01337167|3078693|Superiority or Other||Mean Difference (Final Values)|-13.2|||||2-Sided|95.0|-18.6|-7.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, rectal <38°C|
1673765|NCT01337167|3078693|Superiority or Other||Mean Difference (Final Values)|0.9|||||2-Sided|95.0|-0.6|2.2|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes >=39.5°C|
1673766|NCT01337167|3078693|Superiority or Other||Mean Difference (Final Values)|7.1|||||2-Sided|95.0|2.8|11.2|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes >=38.5°C and <39.5°C|
1673767|NCT01337167|3078693|Superiority or Other||Mean Difference (Final Values)|5.1|||||2-Sided|95.0|0.5|9.5|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes >=38°C and <38.5°C|
1673768|NCT01337167|3078693|Superiority or Other||Mean Difference (Final Values)|-13.1|||||2-Sided|95.0|-18.4|-7.7|||||Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.|Estimated difference, all routes <38°C|
1673769|NCT01337167|3078697|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (V419/Control)|1.02|||<|0.001|2-Sided|95.0|0.83|1.24|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673770|NCT01337167|3078698|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (V419/Control)|1.62|||<|0.001|2-Sided|95.0|1.32|1.98|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673771|NCT01337167|3078699|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (V419/Control)|1.58|||<|0.001|2-Sided|95.0|1.41|1.78|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673772|NCT01337167|3078700|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (V419/Control)|0.78||||0.014|2-Sided|95.0|0.68|0.89|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673773|NCT01337167|3078701|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (V419/Control)|1.0|||<|0.001|2-Sided|95.0|0.91|1.1|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673774|NCT01337167|3078702|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (V419/Control)|1.4|||<|0.001|2-Sided|95.0|1.28|1.52|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673775|NCT01337167|3078703|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (V419 - Ctrl)|6.18|||<|0.001|2-Sided|95.0|3.26|9.78|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673776|NCT01337167|3078704|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (V419 - Ctrl)|-0.41|||<|0.001|2-Sided|95.0|-3.46|3.1|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673777|NCT01337167|3078705|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (V419 - Ctrl)|1.3|||<|0.001|2-Sided|95.0|-1.67|4.78|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673778|NCT01337167|3078706|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (V419 - Ctrl)|1.88|||<|0.001|2-Sided|95.0|0.39|4.18|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673779|NCT01337167|3078707|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (V419/Control)|1.28|||<|0.001|2-Sided|95.0|1.15|1.42|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673780|NCT01337167|3078708|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (V419/Control)|0.83|||<|0.001|2-Sided|95.0|0.73|0.95|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673781|NCT01337167|3078709|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is >=0.67|GMC Ratio (V419/Control)|0.64||||0.786|2-Sided|95.0|0.59|0.7|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673782|NCT01337167|3078710|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 2-sided 95% CI of the Geometric Mean Concentration (GMC) ratio is >=0.67|GMC Ratio (V419/Control)|1.28|||<|0.001|2-Sided|95.0|1.2|1.38|||ANCOVA|GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine|||
1673783|NCT01337167|3078711|Superiority or Other||Response Rate|100.0|||<|0.001|2-Sided|95.0|99.53|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is >=90|||
1673810|NCT01336972|3078751|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment|
1673811|NCT01336972|3078751|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment|
1673784|NCT01337167|3078711|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5%|Response Rate Difference (V419 - Ctrl)|0.25|||<|0.001|2-Sided|95.0|-0.24|1.41|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673785|NCT01337167|3078712|Superiority or Other||Response Rate|100.0|||<|0.001|2-Sided|95.0|99.54|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is >=90|||
1673786|NCT01337167|3078712|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5%|Response Rate Difference (V419 - Ctrl)|0.26|||<|0.001|2-Sided|95.0|-0.22|1.42|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673787|NCT01337167|3078713|Superiority or Other||Response Rate|100.0|||<|0.001|2-Sided|95.0|99.54|100.0|||Clopper and Pearson|Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is >=90|||
1673788|NCT01337167|3078713|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5%|Response Rate Difference (V419 - Ctrl)|1.76|||<|0.001|2-Sided|95.0|0.85|3.59|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673789|NCT01337167|3078714|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (V419 - Ctrl)|4.05|||<|0.001|2-Sided|95.0|0.23|8.28|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673790|NCT01337167|3078715|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (V419 - Ctrl)|-2.67|||<|0.001|2-Sided|95.0|-7.27|2.23|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673791|NCT01337167|3078716|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (V419 - Ctrl)|-4.7||||0.001|2-Sided|95.0|-8.14|-0.97|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673792|NCT01337167|3078717|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (V419 - Ctrl)|-0.33|||<|0.001|2-Sided|95.0|-1.8|1.6|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673793|NCT01337167|3078718|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5%|Response Rate Difference (V419 - Ctrl)|0.39|||<|0.001|2-Sided|95.0|-0.28|1.74|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673794|NCT01337167|3078719|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (V419 - Ctrl)|-3.84||||0.002|2-Sided|95.0|-8.02|0.66|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673795|NCT01337167|3078720|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (V419 - Ctrl)|0.84|||<|0.001|2-Sided|95.0|-0.35|2.74|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine|||
1673796|NCT01337167|3078721|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (V419-Ctrl)|4.87|||<|0.001|2-Sided|95.0|2.23|8.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Secondary Analysis: Non-inferiority for titer >=0.15 μg/mL|
1673797|NCT01337167|3078721|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -5%|Response Rate Difference (V419 - Ctrl)|4.87|||<|0.001|2-Sided|95.0|2.23|8.14|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer >=0.15 μg/mL|
1673798|NCT01337167|3078721|Non-Inferiority or Equivalence|Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is >= -10%|Response Rate Difference (V419 - Ctrl)|9.68|||<|0.001|2-Sided|95.0|4.83|14.83|||Miettinen and Nurminen|Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine||Non-inferiority for titer >=1.0 μg/mL|
1673799|NCT01337115|3078722|Superiority or Other||Mean Difference (Final Values)|-2.55|Standard Error of the Mean|7.14||0.723|2-Sided|95.0|-16.93|11.83|||t-test, 2 sided|||Null hypothesis states there is no difference between both groups. Power 80% to detect 15% difference in means|
1673800|NCT01337115|3078723|Superiority or Other||Median Difference (Final Values)|16.92|Standard Error of the Mean|5.67||0.006|2-Sided|95.0|5.52|28.33|||t-test, 2 sided|||Null hypothesis states that there is no difference between groups. Power 80%|
1673801|NCT01337115|3078724|Superiority or Other|||||||0.537||||||The null hypothesis is that there is no difference in patient satisfaction distribution by the three categories used (Bad; Reasonable; Good/Very Good) between groups.|Fisher's exact test|Fisher's Exact test allows to test for the significance of the distribution in the results table with three categories.|||
1673802|NCT01337115|3078725|Superiority or Other||Mean Difference (Final Values)|28.44|Standard Error of the Mean|8.4||0.001|2-Sided|95.0|11.55|45.34|||t-test, 2 sided|||Difference between mean VAS pain scores. Power 80%. Null hypothesis states there is no difference between pains scores in both groups|
1673803|NCT01336972|3078751|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment|
1673804|NCT01336972|3078751|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment|
1673805|NCT01336972|3078751|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment|
1673815|NCT01336972|3078752|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment|
1673816|NCT01336972|3078752|Superiority or Other||||||>|0.05|||||||Paired t-test|||Test to compare PostTreatment versus Baseline for all treatment groups|
1673817|NCT01336972|3078752|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment|
1673818|NCT01336972|3078752|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment|
1673819|NCT01336972|3078752|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment|
1673820|NCT01336972|3078752|Superiority or Other||||||<|0.05|||||||Paired t-test|||Test to compare Final Treatment versus Baseline for all treatment groups|
1673821|NCT01336972|3078753|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment|
1673822|NCT01336972|3078753|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment|
1673823|NCT01336972|3078753|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Post Treatment|
1673824|NCT01336972|3078753|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment|
1673825|NCT01336972|3078753|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment|
1673826|NCT01336972|3078753|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Test to compare treatment groups at Final Treatment|
1673827|NCT01336972|3078753|Superiority or Other||||||<|0.05|||||||paired t-test|||Comparison of all treatment groups versus Baseline at Post Treatment|
1673828|NCT01336972|3078753|Superiority or Other||||||<|0.05|||||||paired t-test|||Comparison of all treatment groups versus Baseline at Final Treatment|
1673829|NCT01336972|3078757|Superiority or Other||||||<|0.05||||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)||||
1673830|NCT01336972|3078757|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)||||
1673831|NCT01336972|3078757|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)||||
1673832|NCT01336972|3078757|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)||||
1673833|NCT01336972|3078757|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Final Treatment|paired t-test||||
1673834|NCT01336972|3078757|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|Test to compare treatment groups at Final Treatment|||
1673835|NCT01336972|3078757|Superiority or Other||||||<|0.05|||||||paired t-test|||Test to compare Post Treatment versus Baseline|
1673836|NCT01336972|3078757|Superiority or Other||||||>|0.05|||||||paired t-test|||Test to compare Post Treatment versus Baseline|
1673837|NCT01336972|3078757|Superiority or Other||||||>|0.05|||||||paired t-test|||Test to compare Post Treatment versus Baseline|
1673838|NCT01336972|3078757|Superiority or Other||||||<|0.05|||||||paired t-test|||Test to compare Final Treatment versus Baseline for all treatment groups|
1673839|NCT01336972|3078758|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673840|NCT01336972|3078758|Superiority or Other||||||<|0.05||||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673841|NCT01336972|3078758|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673842|NCT01336972|3078758|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673843|NCT01336972|3078758|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding|
1673844|NCT01336972|3078758|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673845|NCT01336972|3078758|Superiority or Other||||||>|0.05||||||Test to compare Post Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673846|NCT01336972|3078758|Superiority or Other||||||>|0.05||||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673847|NCT01336972|3078759|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673848|NCT01336972|3078759|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673849|NCT01336972|3078759|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673850|NCT01336972|3078759|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673851|NCT01336972|3078759|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673852|NCT01336972|3078759|Superiority or Other||||||>|0.05||||||Test to compare Post Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673853|NCT01336972|3078759|Superiority or Other||||||>|0.05||||||Test to compare Final Treatment versus Baseline for all treatment groups|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673854|NCT01336972|3078760|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673855|NCT01336972|3078760|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673856|NCT01336972|3078760|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Post Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673857|NCT01336972|3078760|Superiority or Other||||||<|0.05||||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673858|NCT01336972|3078760|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673859|NCT01336972|3078760|Superiority or Other||||||>|0.05||||||Test to compare treatment groups at Final Treatment|Wilcoxon (Mann-Whitney)|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673860|NCT01336972|3078760|Superiority or Other||||||>|0.05||||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673861|NCT01336972|3078760|Superiority or Other||||||>|0.05||||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673862|NCT01336972|3078760|Superiority or Other||||||>|0.05||||||Test to compare Post Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673863|NCT01336972|3078760|Superiority or Other||||||>|0.05||||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673864|NCT01336972|3078760|Superiority or Other||||||<|0.05||||||Test to compare Final Treatment versus Baseline|paited t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673865|NCT01336972|3078760|Superiority or Other||||||<|0.05||||||Test to compare Final Treatment versus Baseline|paired t-test|||A change of 10% was chosen as representing a clinically significant change in mGFR or ERPF. For this purpose, the alpha level was set at 0.05 and the beta level (power) at 95% instead of 80%, to decrease the chance of a false-negative finding.|
1673866|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.67|Standard Error of the Mean|0.404||0.0962|2-Sided|95.0|-0.12|1.47||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1674076|NCT01333501|3079199|Superiority or Other||Mean Difference (Net)|1.86|Standard Error of the Mean|2.7||0.494|2-Sided|95.0|-3.51|7.23|||ANCOVA||||
1673867|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.02|Standard Error of the Mean|0.411||0.9638|2-Sided|95.0|-0.79|0.83||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673868|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.13|Standard Error of the Mean|0.413||0.7529|2-Sided|95.0|-0.68|0.94||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673869|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.13|Standard Error of the Mean|0.41||0.7514|2-Sided|95.0|-0.68|0.94||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673870|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.34|Standard Error of the Mean|0.357||0.3395|2-Sided|95.0|-0.36|1.04||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673871|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.12|Standard Error of the Mean|0.365||0.7325|2-Sided|95.0|-0.59|0.84||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673872|NCT01336738|3078784|Superiority or Other||LS Mean Difference|-0.05|Standard Error of the Mean|0.367||0.8884|2-Sided|95.0|-0.77|0.67||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673873|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.36|Standard Error of the Mean|0.363||0.3196|2-Sided|95.0|-0.35|1.08||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673874|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.59|Standard Error of the Mean|0.269||0.0298|2-Sided|95.0|0.06|1.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673875|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.18|Standard Error of the Mean|0.272||0.513|2-Sided|95.0|-0.36|0.71||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673876|NCT01336738|3078784|Superiority or Other||LS Mean Difference|-0.19|Standard Error of the Mean|0.272||0.4913|2-Sided|95.0|-0.72|0.35||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673877|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.39|Standard Error of the Mean|0.272||0.1562|2-Sided|95.0|-0.15|0.92||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673878|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.36|Standard Error of the Mean|0.241||0.1369|2-Sided|95.0|-0.11|0.83||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673879|NCT01336738|3078784|Superiority or Other||LS Mean Difference|-0.01|Standard Error of the Mean|0.242||0.9511|2-Sided|95.0|-0.49|0.46||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673880|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.05|Standard Error of the Mean|0.241||0.8493|2-Sided|95.0|-0.43|0.52||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673881|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.29|Standard Error of the Mean|0.242||0.2266|2-Sided|95.0|-0.18|0.77||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673882|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.46|Standard Error of the Mean|0.223||0.0399|2-Sided|95.0|0.02|0.9||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673883|NCT01336738|3078784|Superiority or Other||LS Mean Difference|-0.02|Standard Error of the Mean|0.225||0.92|2-Sided|95.0|-0.47|0.42||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1674077|NCT01333436|3079205|Superiority or Other||Mean Difference (Net)|-1.4|Standard Deviation|4.8||0.1798||95.0|||||t-test, 2 sided||||
1673884|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.04|Standard Error of the Mean|0.224||0.8602|2-Sided|95.0|-0.4|0.48||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673885|NCT01336738|3078784|Superiority or Other||LS Mean Difference|0.28|Standard Error of the Mean|0.225||0.2067|2-Sided|95.0|-0.16|0.73||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673886|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.59|Standard Error of the Mean|0.133|<|0.0001|2-Sided|80.0|-0.76|-0.42||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673887|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.58|Standard Error of the Mean|0.138|<|0.0001|2-Sided|80.0|-0.76|-0.41||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673888|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.137|<|0.002|2-Sided|80.0|-0.57|-0.22||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673889|NCT01336738|3078786|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.135|<|0.4887|2-Sided|80.0|-0.18|0.17||One-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673890|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.34|Standard Error of the Mean|0.094|<|0.0002|2-Sided|80.0|-0.46|-0.22||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673891|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.37|Standard Error of the Mean|0.098|<|0.0001|2-Sided|80.0|-0.5|-0.24||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673892|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.24|Standard Error of the Mean|0.097|<|0.0067|2-Sided|80.0|-0.36|-0.12||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673893|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.096|<|0.1405|2-Sided|80.0|-0.23|0.02||One-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673894|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.065|<|0.0009|2-Sided|80.0|-0.29|-0.12||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673895|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.18|Standard Error of the Mean|0.067|<|0.004|2-Sided|80.0|-0.27|-0.09||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673896|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.11|Standard Error of the Mean|0.066|<|0.0439|2-Sided|80.0|-0.2|-0.03||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673897|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.03|Standard Error of the Mean|0.066|<|0.3466|2-Sided|80.0|-0.11|0.06||One-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673898|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.06|Standard Error of the Mean|0.049|<|0.1251|2-Sided|80.0|-0.12|0.01||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673899|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.13|Standard Error of the Mean|0.049|<|0.0036|2-Sided|80.0|-0.2|-0.07||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1674078|NCT01333436|3079206|Superiority or Other||Mean Difference (Net)|5.5|Standard Deviation|13.9||0.0675||95.0|||||t-test, 2 sided||||
1674091|NCT01333189|3079225|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Internal moment at the knee|
1673900|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.02|Standard Error of the Mean|0.048|<|0.358|2-Sided|80.0|-0.08|0.04||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673901|NCT01336738|3078786|Superiority or Other||LS Mean Difference|-0.04|Standard Error of the Mean|0.048|<|0.2327|2-Sided|80.0|-0.1|0.03||One-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673902|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-24.96|Standard Error of the Mean|6.821||0.0003|2-Sided|95.0|-38.4|-11.53||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673903|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-1.61|Standard Error of the Mean|6.998||0.8183|2-Sided|95.0|-15.4|12.18||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673904|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|6.986||0.9202|2-Sided|95.0|-14.47|13.07||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673905|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-2.01|Standard Error of the Mean|6.94||0.7724|2-Sided|95.0|-15.68|11.66||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673906|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-21.52|Standard Error of the Mean|5.818||0.0003|2-Sided|95.0|-32.97|-10.07||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673907|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-6.62|Standard Error of the Mean|5.94||0.2662|2-Sided|95.0|-18.31|5.08||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673908|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-8.53|Standard Error of the Mean|5.913||0.1505|2-Sided|95.0|-20.17|3.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673909|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-1.1|Standard Error of the Mean|5.855||0.8509|2-Sided|95.0|-12.63|10.43||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673910|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-22.83|Standard Error of the Mean|5.198|<|0.0001|2-Sided|95.0|-33.06|-12.6||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673911|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-7.38|Standard Error of the Mean|5.235|<|0.1596|2-Sided|95.0|-17.69|2.92||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673912|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-4.14|Standard Error of the Mean|5.209|<|0.4276|2-Sided|95.0|-14.39|6.12||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673913|NCT01336738|3078787|Superiority or Other||LS Mean Difference|3.13|Standard Error of the Mean|5.201|<|0.5479|2-Sided|95.0|-7.11|13.37||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673914|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-17.32|Standard Error of the Mean|5.039|<|0.0007|2-Sided|95.0|-27.24|-7.4||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673915|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-6.56|Standard Error of the Mean|5.03|<|0.1934|2-Sided|95.0|-16.46|3.34||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673916|NCT01336738|3078787|Superiority or Other||LS Mean Difference|3.87|Standard Error of the Mean|5.001|<|0.4396|2-Sided|95.0|-5.98|13.72||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1674092|NCT01333189|3079225|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Internal moment at the hip|
1673917|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-2.43|Standard Error of the Mean|5.02|<|0.6291|2-Sided|95.0|-12.31|7.46||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673918|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-15.07|Standard Error of the Mean|5.34|<|0.0051|2-Sided|95.0|-25.58|-4.55||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673919|NCT01336738|3078787|Superiority or Other||LS Mean Difference|-3.22|Standard Error of the Mean|5.364|<|0.549|2-Sided|95.0|-13.78|7.34||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673920|NCT01336738|3078787|Superiority or Other||LS Mean Difference|1.32|Standard Error of the Mean|5.296|<|0.8031|2-Sided|95.0|-9.11|11.75||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673921|NCT01336738|3078787|Superiority or Other||LS Mean Difference|3.78|Standard Error of the Mean|5.292|<|0.4757|2-Sided|95.0|-6.64|14.2||Two-sided p-value was calculated.|Mixed Models Analysis|||Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.|
1673922|NCT01336738|3078788|Superiority or Other||LS Mean Difference|-0.71|Standard Error of the Mean|0.162|<|0.0001|2-Sided|80.0|-0.91|-0.5||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673923|NCT01336738|3078788|Superiority or Other||LS Mean Difference|-0.58|Standard Error of the Mean|0.168|<|0.0003|2-Sided|80.0|-0.8|-0.36||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673924|NCT01336738|3078788|Superiority or Other||LS Mean Difference|-0.49|Standard Error of the Mean|0.166|<|0.0017|2-Sided|80.0|-0.71|-0.28||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673925|NCT01336738|3078788|Superiority or Other||Least Squares (LS) Mean Difference|0.08|Standard Error of the Mean|0.164|<|0.6803|2-Sided|80.0|-0.13|0.29||One-sided p-value was calculated.|Mixed Models Analysis|||Treatment difference and 80% confidence interval (CI) were based on LS mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.|
1673926|NCT01336647|3078797|Non-Inferiority or Equivalence (legacy)|The primary efficacy endpoint was responder rate calculated based on the percentage of subjects who were lice free at all follow-up visits (Days 1, 7 and 14). Because the number of responders and non-responders in the family size>= 5 household members was less than five in at least one of the treatment arms, (Table 14.2.1.5), Fisher’s Exact test was used to compare treatment arms, instead of the CMH test.|||||<|0.001|||||||Fisher Exact|The assessment of statistical significance will be done using Hochberg’s modified Bonferroni test.||Null hypothesis; 80% power and 0.025 two-sided level of significance for each pairwise active vs. vehicle comparison|
1673927|NCT01336608|3078853|Superiority or Other||Least Squares Mean Difference|-0.03||||0.803|2-Sided|95.0|-0.29|0.22|||ANCOVA||||
1673928|NCT01336608|3078853|Superiority or Other||Least Squares Mean Difference|-0.5|||<|0.001|2-Sided|95.0|-0.76|-0.24||Nominal p-value|ANCOVA||||
1673929|NCT01336608|3078853|Superiority or Other||Least Squares Mean Difference|-0.47|||<|0.001|2-Sided|95.0|-0.72|-0.22||Nominal p-value|ANCOVA||||
1673930|NCT01336608|3078854|Superiority or Other||Least squares mean difference|0.074||||0.012|2-Sided|95.0|0.016|0.131||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1673931|NCT01336608|3078854|Superiority or Other||Least squares mean difference|0.155|||<|0.001|2-Sided|95.0|0.095|0.215||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1673932|NCT01336608|3078854|Superiority or Other||Least squares mean difference|0.082|||<|0.007|2-Sided|95.0|0.023|0.141||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1673933|NCT01336608|3078855|Superiority or Other||Least Squares Mean Difference|0.2||||0.566|2-Sided|95.0|-0.49|0.89|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|||
1673934|NCT01336608|3078855|Superiority or Other||Least Squares Mean Difference|0.22||||0.568|2-Sided|95.0|-0.53|0.96|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|||
1673935|NCT01336608|3078855|Superiority or Other||Least Squares Mean Difference|0.01||||0.969|2-Sided|95.0|-0.71|0.74|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM)|||
1673936|NCT01336140|3078874|Superiority or Other|||||||1|||||||Chi-squared||||
1673937|NCT01336140|3078875|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1673938|NCT01336140|3078876|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1673939|NCT01336140|3078877|Superiority or Other|||||||0.002|||||||Chi-squared|||"We calculated that a minimum of 248 subjects are needed to attain 80% power to detect 70% reduction in the incidence of the primary endpoint (diarrhea), assuming an event rate of 15% in the control group (2-tailed α = 0.05). We targeted enrolling 300 patients to allow some room for error in our assumptions.~null hypothesis: incidence of diarrhea is no different between the aminophylline arm and the placebo arm."|
1674093|NCT01333189|3079226|Superiority or Other||||||=|0|||||||Mixed Models Analysis||||
1673940|NCT01336023|3078882|Superiority|"Superiority of IDegLira over liraglutide was confirmed when the 95% confidence interval for the treatment difference for change in HbA1c lies entirely below 0%.~IDegLira minus Liraglutide"|Treatment contrast|-0.64|||||2-Sided|95.0|-0.75|-0.53|||||IDegLira minus Liraglutide||
1673941|NCT01336023|3078882|Non-Inferiority|"Non-inferiority of IDegLira vs. IDeg was confirmed when 95% confidence interval for the treatment differences for change in HbA1c lies entirely below 0.3%.~IDegLira minus IDeg"|Treatment Contrast|-0.47|||||2-Sided|95.0|-0.58|-0.36|||||IDegLira minus IDeg||
1673942|NCT01335971|3078885|Superiority or Other|||||||0.53|||||||Kruskal-Wallis|||Applies to total antioxidants results.|
1673943|NCT01335971|3078885|Superiority or Other|||||||0.35|||||||Kruskal-Wallis|||Applies to thiobarbituric acid reactive substances results.|
1673944|NCT01335971|3078885|Superiority or Other|||||||0.8|||||||Kruskal-Wallis|||Applies to isoprostane results.|
1673945|NCT01335971|3078886|Superiority or Other|||||||0.33|||||||Kruskal-Wallis|||Applies to secretory leukoprotease inhibitor results|
1673946|NCT01335971|3078886|Superiority or Other|||||||0.71|||||||Kruskal-Wallis|||Applies to interleukin-8 results|
1673947|NCT01335971|3078887|Superiority or Other|||||||0.65|||||||Kruskal-Wallis|||Applies to Interleukin-8 concentration|
1673948|NCT01335971|3078887|Superiority or Other|||||||0.07|||||||Kruskal-Wallis|||Applies to Interleukin-6 concentration|
1673949|NCT01335971|3078887|Superiority or Other|||||||0.41|||||||Kruskal-Wallis|||Applies to C-reactive protein concentration|
1673950|NCT01335971|3078888|Superiority or Other|||||||0.2|||||||Kruskal-Wallis||||
1673951|NCT01335971|3078889|Superiority or Other|||||||0.06|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells.|
1673952|NCT01335971|3078890|Superiority or Other||||||<|0.01|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells.|
1673953|NCT01335971|3078891|Superiority or Other|||||||0.53|||||||Kruskal-Wallis|||Applies to gene expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells|
1673954|NCT01335971|3078892|Superiority or Other||||||<|0.01|||||||Kruskal-Wallis|||Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in bronchial epithelial cells|
1673955|NCT01335971|3078892|Superiority or Other||||||<|0.69|||||||Kruskal-Wallis|||Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in bronchial epithelial cells|
1673956|NCT01335971|3078893|Superiority or Other|||||||0.68|||||||Kruskal-Wallis|||Applies to gene expression of Nrf2 in bronchial epithelial cells|
1673957|NCT01335971|3078894|Superiority or Other|||||||0.71|||||||Kruskal-Wallis|||Applies to gene expression of Kelch Like ECH Associated Protein 1 (Keap1) in alveolar macrophages|
1673958|NCT01335971|3078894|Superiority or Other|||||||0.88|||||||Kruskal-Wallis|||Applies to gene expression of nuclear factor erythroid 2 like 2 (Nrf2) in alveolar macrophages|
1673959|NCT01335971|3078894|Superiority or Other|||||||0.49|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in alveolar macrophages|
1673960|NCT01335971|3078894|Superiority or Other|||||||0.75|||||||Kruskal-Wallis|||Applies to gene expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in alveolar macrophages|
1673961|NCT01335971|3078894|Superiority or Other|||||||0.4|||||||Kruskal-Wallis|||Applies to gene expression of Heme Oxygenase 1 (HO1) in alveolar macrophages|
1673962|NCT01335971|3078894|Superiority or Other|||||||0.45|||||||Kruskal-Wallis|||Applies to gene expression of NAD(P)H Quinone Dehydrogenase 1 (NQ01) in alveolar macrophages|
1673963|NCT01335932|3078928|Other|||||||0.45|||||||t-test, 2 sided||||
1673964|NCT01335932|3078929|Other|||||||0.93|||||||t-test, 2 sided||||
1673965|NCT01335932|3078930|Other|||||||0.93|||||||t-test, 2 sided||||
1673966|NCT01335932|3078931|Other|||||||0.8|||||||t-test, 2 sided||||
1673967|NCT01335932|3078932|Other|||||||0.37|||||||t-test, 2 sided||||
1673968|NCT01335932|3078933|Other|||||||0.94|||||||t-test, 2 sided||||
1673969|NCT01335932|3078934|Other|||||||0.92|||||||t-test, 2 sided||||
1673970|NCT01335932|3078935|Other|||||||0.45|||||||t-test, 2 sided||||
1673971|NCT01335932|3078936|Other|||||||0.76|||||||t-test, 2 sided||||
1673972|NCT01335932|3078937|Other|||||||0.24|||||||t-test, 2 sided||||
1673973|NCT01335932|3078938|Other|||||||0.64|||||||t-test, 2 sided||||
1673974|NCT01335932|3078939|Other|||||||0.008|||||||t-test, 2 sided||||
1673975|NCT01335932|3078940|Other|||||||0.13|||||||t-test, 2 sided||||
1673976|NCT01335932|3078941|Other|||||||0.12|||||||t-test, 2 sided||||
1673977|NCT01335932|3078942|Other|||||||0.51|||||||t-test, 2 sided||||
1673978|NCT01335932|3078943|Other|||||||0.63|||||||t-test, 2 sided||||
1673979|NCT01335932|3078944|Other|||||||0.96|||||||t-test, 2 sided||||
1673980|NCT01335932|3078945|Other|||||||0.31|||||||t-test, 2 sided||||
1673981|NCT01335932|3078946|Other|||||||0.33|||||||t-test, 2 sided||||
1673982|NCT01335932|3078947|Other|||||||0.73|||||||t-test, 2 sided||||
1673983|NCT01335932|3078948|Other||||||<|0.0001|||||||t-test, 2 sided||||
1673984|NCT01335932|3078949|Other|||||||0.03|||||||t-test, 2 sided||||
1673985|NCT01335932|3078950|Other|||||||0.002|||||||t-test, 2 sided||||
1673986|NCT01335932|3078951|Other|||||||0.1|||||||Fisher Exact||||
1673987|NCT01335932|3078952|Other|||||||0.14|||||||Fisher Exact||||
1673988|NCT01335932|3078953|Other|||||||0.006|||||||Fisher Exact||||
1673989|NCT01335932|3078959|Other|||||||0.31|||||||t-test, 2 sided||||
1673990|NCT01335932|3078960|Other|||||||0.0001|||||||Fisher Exact||||
1673991|NCT01335867|3078962|Superiority|||||||0.64|||||||t-test, 2 sided||||
1673992|NCT01335867|3078963|Superiority|||||||0.2|||||||Chi-squared||||
1673993|NCT01335867|3078964|Superiority|||||||0.24|||||||t-test, 2 sided||||
1673994|NCT01335867|3078966|Superiority|||||||0.14|||||||Chi-squared||||
1673995|NCT01335620|3079008|Superiority|||||||0.018|||||||Regression, Logistic|||Compare baseline to 24 weeks|
1674094|NCT01333189|3079227|Superiority or Other||||||=|0|||||||Mixed Models Analysis||||
1673996|NCT01335477|3079013|Superiority or Other||Mean Difference (Final Values)|0.113|Standard Error of the Mean|0.1005||0.26||95.0|-0.084|0.31|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline DLCO (HGB Corrected) [mmol/min/kPa], baseline DLCO (HGB Corrected) [mmol/min/kPa]-by-visit and random effect for patient.|
1673997|NCT01335477|3079014|Superiority or Other||Mean Difference (Final Values)|0.27|Standard Error of the Mean|0.213||0.2032||95.0|-0.15|0.69|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline SpO2, baseline SpO2-by-visit and random effect for patient.|
1673998|NCT01335477|3079015|Superiority or Other||Hazard Ratio (HR)|0.8||||0.2123||95.0|0.55|1.16|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.|
1673999|NCT01335477|3079016|Superiority or Other||Hazard Ratio (HR)|0.67||||0.1664||95.0|0.37|1.21|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.|
1674000|NCT01335477|3079017|Superiority or Other||Hazard Ratio (HR)|0.68||||0.2209||95.0|0.34|1.35|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height.|
1674001|NCT01335477|3079018|Superiority or Other||Hazard Ratio (HR)|0.86||||0.6654||95.0|0.39|1.9|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height.|
1674002|NCT01335477|3079019|Superiority or Other||Hazard Ratio (HR)|0.74||||0.2995||95.0|0.4|1.35|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height.|
1674003|NCT01335477|3079020|Superiority or Other||Risk Ratio (RR)|0.38||||0.007||95.0|0.19|0.77|||Normal distribution|Risk ratio was calculated as the ratio of risk of exacerbation in both treatment groups.|Nintedanib 150 mg bid versus Placebo|The log of the risk ratio was assumed to follow a normal distribution with mean 0 and variance equal to the sum of the reciprocals of the number of patients with at least one exacerbation in each treatment arm.|
1674004|NCT01335477|3079022|Superiority or Other||Odds Ratio (OR)|1.379||||0.069||95.0|0.98|1.95|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with term treatment|
1674005|NCT01335477|3079023|Superiority or Other||Mean Difference (Final Values)|1.81|Standard Error of the Mean|1.564||0.2475||95.0|-1.26|4.88|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough impact score, baseline CASA-Q Cough impact score-by-visit and random effect for patient.|
1674006|NCT01335477|3079024|Superiority or Other||Mean Difference (Final Values)|2.05|Standard Error of the Mean|1.713||0.2326||95.0|-1.31|5.41|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough symptoms score, baseline CASA-Q Cough symptoms score-by-visit and random effect for patient.|
1674007|NCT01335477|3079025|Superiority or Other||Mean Difference (Final Values)|-2.38|Standard Error of the Mean|1.685||0.1587||95.0|-5.68|0.93|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SOBQ score, baseline SOBQ score-by-visit and random effect for patient.|
1674008|NCT01335477|3079026|Superiority or Other||Mean Difference (Final Values)|-3.12|Standard Error of the Mean|1.192||0.0089||95.0|-5.46|-0.79|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ-I Total score, baseline SGRQ-I Total score-by-visit and random effect for patient.|
1674009|NCT01335477|3079027|Superiority or Other||Mean Difference (Final Values)|-3.31|Standard Error of the Mean|1.36||0.0152||95.0|-5.97|-0.64|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Activities component, baseline SGRQ Activities component-by-visit and random effect for patient|
1674010|NCT01335477|3079028|Superiority or Other||Mean Difference (Final Values)|-3.08|Standard Error of the Mean|1.342||0.022||95.0|-5.71|-0.45|||Mixed Models Analysis||"Within-patient error are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ impact component, baseline SGRQ impact component-by-visit and random effect for patient|
1674011|NCT01335477|3079029|Superiority or Other||Mean Difference (Final Values)|-1.4|Standard Error of the Mean|1.675||0.4019||95.0|-4.69|1.88|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Symptoms component, baseline SGRQ Symptoms component-by-visit and random effect for patient.|
1674012|NCT01335477|3079030|Superiority or Other||Odds Ratio (OR)|1.664||||0.0218||95.0|1.08|2.57|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, baseline SGRQ total score|
1674013|NCT01335477|3079031|Superiority or Other||Odds Ratio (OR)|1.794||||0.0011||95.0|1.26|2.55|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted.|
1674014|NCT01335477|3079032|Superiority or Other||Odds Ratio (OR)|1.286||||0.1833||95.0|0.89|1.86|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted|
1674079|NCT01333436|3079207|Superiority or Other||Mean Difference (Final Values)|21.8|Standard Deviation|36.8||0.0078||95.0|||||t-test, 2 sided||||
1674095|NCT01333189|3079228|Superiority or Other||||||=|0|||||||Mixed Models Analysis||||
1674015|NCT01335477|3079035|Superiority or Other||Mean Difference (Final Values)|4.21|Standard Error of the Mean|0.743|<|0.0001||95.0|2.76|5.67|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC [%predicted], baseline FVC [%predicted]-by-visit and random effect for patient.|
1674016|NCT01335477|3079036|Superiority or Other||Mean Difference (Final Values)|3.06|Standard Error of the Mean|0.607|<|0.0001||95.0|1.87|4.25|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC [%predicted], baseline FVC [%predicted]-by-visit and random effect for patient.|
1674017|NCT01335477|3079037|Superiority or Other||Mean Difference (Final Values)|4.24|Standard Error of the Mean|0.742|<|0.0001||95.0|2.78|5.69|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.|
1674018|NCT01335477|3079038|Superiority or Other||Mean Difference (Final Values)|109.77|Standard Error of the Mean|19.808|<|0.0001||95.0|70.92|148.62|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.|
1674019|NCT01335477|3079039|Superiority or Other||Hazard Ratio (HR)|0.38||||0.005||95.0|0.19|0.77|||Log Rank||Nintedanib 150 mg bid versus Placebo.|Hazard Ratio is based on a Cox's regression model with terms for treatment, gender, age and height.|
1674020|NCT01335477|3079040|Superiority or Other||Mean Difference (Final Values)|-2.69|Standard Error of the Mean|1.151||0.0197||95.0|-4.95|-0.43|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo."|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Total score, baseline SGRQ Total score-by-visit and random effect for patient.|
1674021|NCT01335477|3079041|Superiority or Other||Mean Difference (Final Values)|93.73|Standard Error of the Mean|24.907||0.0002||95.0|44.78|142.68||The objective of this trial was to assess the superiority of nintedanib 150 mg bid compared to placebo on the annual rate of decline in FVC.|Random coefficient regression|The Roger-Kenward approximation was used to estimate denominators degrees of freedom.|"Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-components variance-covariance matrix.~Nintedanib 150 mg bid versus Placebo."|"Random coefficient regression with fixed effects for treatment, gender, age, height and random effect of patient specific intercept and time.~A hierarchical procedure was used in order to demonstrate the superiority of nintedanib over placebo for one primary and two key secondary endpoints.~The consecutive steps of the hierarchy were only considered if the previous step was significant at the one-sided 2.5% level and the results were in favour of nintedanib."|
1674022|NCT01335464|3079042|Superiority or Other||Mean Difference (Final Values)|-0.015|Standard Error of the Mean|0.0896||0.865|2-Sided|95.0|-0.191|0.161|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg bid versus placebo"|Mixed Model for Repeated Measures with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline DLCO (HGB Corrected) [mmol/min/kPa], baseline DLCO (HGB Corrected) [mmol/min/kPa]-by-visit and random effect for patient.|
1674023|NCT01335464|3079043|Superiority or Other||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.181||0.1138|2-Sided|95.0|-0.07|0.64|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg bid versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline SpO2, baseline SpO2-by-visit and random effect for patient.|
1674024|NCT01335464|3079044|Superiority or Other||Hazard Ratio (HR)|0.81||||0.3558|2-Sided|95.0|0.52|1.25|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height|
1674025|NCT01335464|3079045|Superiority or Other||Hazard Ratio (HR)|0.73||||0.443|2-Sided|95.0|0.36|1.51|||Log Rank||Nintedanib 150mg versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height|
1674026|NCT01335464|3079046|Superiority or Other||Hazard Ratio (HR)|0.68||||0.4869|2-Sided|95.0|0.26|1.82|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height|
1674027|NCT01335464|3079047|Superiority or Other||Hazard Ratio (HR)|0.61||||0.3515|2-Sided|95.0|0.25|1.47|||Log Rank||Nintedanib 150mg versus placebo|Hazard ratio is based on Cox´s regression model with terms for treatment, gender, age and height|
1674028|NCT01335464|3079048|Superiority or Other||Hazard Ratio (HR)|0.63||||0.288|2-Sided|95.0|0.29|1.36|||Log Rank||Nintedanib 150mg bid versus placebo|Hazard ratio is based on a Cox´s regression model with terms for treatment, gender, age and height|
1674029|NCT01335464|3079049|Superiority or Other||Risk Ratio (RR)|1.17||||0.6793|2-Sided|95.0|0.56|2.46|||Normal distribution|Risk ratio was calculated as the ratio of risk of exacerbation in both treatment groups.|Nintedanib 150mg bid versus placebo|The log of the risk ratio was assumed to follow a normal distribution with mean 0 and variance equal to the sum of the reciprocals of the number of patients with at least one exacerbation in each treatment arm.|
1674030|NCT01335464|3079051|Superiority or Other||Odds Ratio (OR)|1.276||||0.1818|2-Sided|95.0|0.89|1.83|||Regression, Logistic||Nintedanib 150mg versus placebo|Logistic regression with term treatment|
1674031|NCT01335464|3079052|Superiority or Other||Mean Difference (Final Values)|1.64|Standard Error of the Mean|1.596||0.3042|2-Sided|95.0|-1.49|4.77|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough impact score, baseline CASA-Q Cough impact score-by-visit and random effect for patient.|
1674080|NCT01333397|3079222|Superiority or Other||||||<|0.0001|||||||Chi-squared|||SSA - Dysport NG 75 U Vs Placebo|
1674032|NCT01335464|3079053|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|1.803||0.8942|2-Sided|95.0|-3.78|3.3|||Mixed Models Analysis||"Within- patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline CASA-Q Cough symptoms score, baseline CASA-Q Cough symptoms score-by-visit and random effect for patient.|
1674033|NCT01335464|3079054|Superiority or Other||Mean Difference (Final Values)|-0.88|Standard Error of the Mean|1.77||0.6203|2-Sided|95.0|-4.35|2.6|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SOBQ score, baseline SOBQ score-by-visit and random effect for patient.|
1674034|NCT01335464|3079055|Superiority or Other||Mean Difference (Final Values)|-0.78|Standard Error of the Mean|1.289||0.5446|2-Sided|95.0|-3.31|1.75|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150mg versus placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ-I Total score, baseline SGRQ-I Total score-by-visit and random effect for patient.|
1674035|NCT01335464|3079056|Superiority or Other||Mean Difference (Final Values)|-1.19|Standard Error of the Mean|1.427||0.4049|2-Sided|95.0|-3.99|1.61|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Activities component, baseline SGRQ Activities component-by-visit and random effect for patient|
1674036|NCT01335464|3079057|Superiority or Other||Mean Difference (Final Values)|0.86|Standard Error of the Mean|1.446||0.551|2-Sided|95.0|-1.97|3.7|||Mixed Models Analysis||"Within-patient error are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ impact component, baseline SGRQ Impact component-by-visit and random effect for patient|
1674037|NCT01335464|3079058|Superiority or Other||Mean Difference (Final Values)|-2.32|Standard Error of the Mean|1.744||0.1832|2-Sided|95.0|-5.74|1.1|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Symptoms component, baseline SGRQ Symptoms component-by-visit and random effect for patient.|
1674038|NCT01335464|3079059|Superiority or Other||Odds Ratio (OR)|0.84||||0.4298|2-Sided|95.0|0.55|1.29|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, baseline SGRQ total score|
1674039|NCT01335464|3079060|Superiority or Other||Odds Ratio (OR)|1.847||||0.001|2-Sided|95.0|1.28|2.66|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted|
1674040|NCT01335464|3079061|Superiority or Other||Odds Ratio (OR)|1.914||||0.0007|2-Sided|95.0|1.32|2.79|||Regression, Logistic||Nintedanib 150 mg bid versus Placebo|Logistic regression with terms treatment, age, gender, height and baseline FVC % predicted|
1674041|NCT01335464|3079064|Superiority or Other||Mean Difference (Final Values)|4.0|Standard Error of the Mean|0.753|<|0.0001|2-Sided|95.0|2.52|5.48|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC [%predicted], baseline FVC [%predicted]-by-visit and random effect for patient.|
1674042|NCT01335464|3079065|Superiority or Other||Mean Difference (Final Values)|3.22|Standard Error of the Mean|0.564|<|0.0001|2-Sided|95.0|2.11|4.33|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC [%predicted], baseline FVC [%predicted]-by-visit and random effect for patient.|
1674043|NCT01335464|3079066|Superiority or Other||Mean Difference (Final Values)|4.02|Standard Error of the Mean|0.753|<|0.0001|2-Sided|95.0|2.54|5.5|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.|
1674044|NCT01335464|3079067|Superiority or Other||Mean Difference (Final Values)|109.93|Standard Error of the Mean|19.708|<|0.0001|2-Sided|95.0|71.27|148.59|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix.~Nintedanib 150 mg bid versus Placebo"|Based on Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, gender, age, height, treatment-by-visit, baseline FVC, baseline FVC-by-visit and random effect for patient.|
1674045|NCT01335464|3079068|Superiority or Other||Hazard Ratio (HR)|1.15||||0.6728|2-Sided|95.0|0.54|2.42|||Log Rank||Nintedanib 150 mg bid versus Placebo|Hazard Ratio is based on a Cox´s regression model with terms for treatment, gender, age and height|
1674046|NCT01335464|3079069|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|1.248||0.9657|2-Sided|95.0|-2.5|2.4|||Mixed Models Analysis||"Within-patient errors are modelled by compound symmetry covariance matrix~Nintedanib 150 mg bid versus Placebo"|Mixed Model for Repeated Measures (MMRM), with fixed effects for treatment, visit, treatment-by-visit, baseline SGRQ Total score, baseline SGRQ Total score-by-visit and random effect for patient.|
1674081|NCT01333397|3079222|Superiority or Other||||||<|0.0001|||||||Chi-squared|||SSA - Dysport NG 50 U Vs Placebo|
1674082|NCT01333397|3079222|Superiority or Other||||||<|0.0001|||||||Chi-squared|||SSA - Dysport NG 20 U Vs Placebo|
1674083|NCT01333397|3079222|Superiority or Other||||||<|0.0001|||||||Chi-squared|||ILA - Dysport NG 75 U Vs Placebo|
1674084|NCT01333397|3079222|Superiority or Other||||||<|0.0001|||||||Chi-squared|||ILA - Dysport NG 50 U Vs Placebo|
1674085|NCT01333397|3079222|Superiority or Other||||||<|0.0001|||||||Chi-squared|||ILA - Dysport NG 20 U Vs Placebo|
1674086|NCT01333189|3079223|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Internal moment at the ankle|
1674087|NCT01333189|3079223|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Internal moment at the knee|
1674047|NCT01335464|3079070|Superiority or Other||Mean Difference (Final Values)|125.26|Standard Error of the Mean|24.209|<|0.0001|2-Sided|95.0|77.68|172.84||The objective of this trial was to assess the superiority of nintedanib 150 mg bid compared to placebo on the annual rate of decline in FVC.|Random coefficient regression|The Roger-Kenward approximation was used to estimate denominators degrees of freedom.|"Within-patient errors are modelled by an Unstructured variance-covariance matrix.~Inter-individual variability is modelled by a Variance-components variance-covariance matrix~Nintedanib 150 mg bid versus Placebo"|"Random coefficient regression with fixed effects for treatment, gender, age, height and random effect of patient specific intercept and time.~A hierarchical procedure was used in order to demonstrate the superiority of nintedanib over placebo for one primary and two key secondary endpoints.~The consecutive steps of the hierarchy were only considered if the previous step was significant at the one-sided 2.5% level and the results were in favour of nintedanib."|
1674048|NCT01335061|3079089|Superiority or Other||||||<|0.0001|||||||Paired t-test||||
1674049|NCT01334918|3079107|Superiority or Other||Sensitivity|0.77|Standard Error of the Mean|0.117|||2-Sided|95.0|0.54|1.0||||||Analysis of sensitivity based on participants with ≥ 1 fixed defect according to SPECT. Sensitivity is the proportion of true positives that are correctly identified using SPECT as the reference standard.|
1674050|NCT01334918|3079107|Superiority or Other||Specificity|0.95|Standard Error of the Mean|0.022|||2-Sided|95.0|0.9|0.99||||||Analysis of specificity based on participants with no fixed defects according to SPECT. Specificity is defined as a proportion of true negatives that are correctly identified, using SPECT as the reference standard.|
1674051|NCT01334918|3079112|Non-Inferiority or Equivalence|Predefined noninferiority criterion: If the lower boundary of the 95% CI was within 0.15 of 0.78, MDCT would be determined to be noninferior to SPECT.|Agreement rate|0.87|Standard Error of the Mean|0.051|||2-Sided|95.0|0.77|0.97||||||Analysis of agreement rate based on participants with 0 -1 and ≥ 2 reversible defects according to SPECT. Agreement is defined as the proportion of participants who had the same status from SPECT and MDCT, averaged across those with 2 or more reversible defects and those without, where SPECT is the reference standard.|
1674052|NCT01334723|3079123|Superiority or Other||Hazard Ratio (HR)|0.436||||||95.0|0.333|0.57|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.||
1674053|NCT01334723|3079123|Superiority or Other||Hazard Ratio (HR)|0.519||||||95.0|0.472|0.57|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.||
1674054|NCT01334723|3079124|Superiority or Other||Hazard Ratio (HR)|0.542||||||95.0|0.427|0.689|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.||
1674055|NCT01334723|3079124|Superiority or Other||Hazard Ratio (HR)|0.613||||||95.0|0.562|0.668|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.||
1674056|NCT01334723|3079125|Superiority or Other||Hazard Ratio (HR)|0.294||||||95.0|0.235|0.368|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.||
1674057|NCT01334723|3079125|Superiority or Other||Hazard Ratio (HR)|0.38||||||95.0|0.35|0.412|||||A time-to-event analysis was used to evaluate the likelihood of AUR or prostate surgery.||
1674058|NCT01334554|3079133|Superiority or Other||Beta coefficient|0.46||||0.649|2-Sided|95.0|-1.58|2.49||Adjusted for baseline values only|Regression, Linear||||
1674059|NCT01334554|3079134|Superiority or Other||Beta coefficient (linear regression)|0.12||||0.55|2-Sided|95.0|-0.33|0.58||p- value was unadjusted. Primary outcome underwent logarithmic transformation|Regression, Linear|||H0= 4-week treatment with sildenafil citrate does not improve insulin sensitivity in obese African American women.|
1674060|NCT01334125|3079144|Superiority or Other|||||||1|||||||t-test, 2 sided|||p value represents the analysis of the nocturnal hypoglycemia|
1674061|NCT01334125|3079144|Superiority or Other|||||||1|||||||t-test, 2 sided|||p value represents the analysis for minor hypoglycemia|
1674062|NCT01334125|3079145|Superiority or Other|||||||0.057|||||||ANOVA|||Two way ANOVA comparison of the means of the adiponectin/leptin ratios between the metformin and placebo groups|
1674063|NCT01334125|3079146|Superiority or Other|||||||0.578||||||Individual two-way mixed ANOVA models were fitted for each of our outcomes of interest, with treatment type (metformin or placebo) as the fixed effect, and baseline values, age, gender, and BMI as covariates.|ANOVA|||Analyses were based on the intent-to-treat principle and were performed using SPSS v.22 (IBM Corporation, Armonk, NY).|
1674064|NCT01334125|3079147|Superiority or Other|||||||0.903||||||Individual two-way mixed ANOVA models were fitted for each of our outcomes of interest, with treatment type (metformin or placebo) as the fixed effect, and baseline values, age, gender, and BMI as covariates.|ANOVA|||Analyses were based on the intent-to-treat principle and were performed using SPSS v.22 (IBM Corporation, Armonk, NY).|
1674065|NCT01333501|3079188|Superiority or Other||Mean Difference (Net)|-5.24|Standard Error of the Mean|3.69||0.161|2-Sided|95.0|-12.62|2.14|||ANCOVA||||
1674066|NCT01333501|3079189|Superiority or Other||Mean Difference (Net)|-2.16|Standard Error of the Mean|2.34||0.3585|2-Sided|95.0|-6.82|2.5|||ANCOVA||||
1674067|NCT01333501|3079190|Superiority or Other||Mean Difference (Net)|-0.25|Standard Error of the Mean|0.59||0.6757|2-Sided|95.0|-1.42|0.92|||ANCOVA||||
1674068|NCT01333501|3079191|Superiority or Other||Mean Difference (Net)|0.16|Standard Error of the Mean|1.18||0.8944|2-Sided|95.0|-2.18|2.5|||ANCOVA||||
1674069|NCT01333501|3079192|Superiority or Other||Mean Difference (Net)|-0.03|Standard Error of the Mean|0.42||0.9496|2-Sided|95.0|-0.86|0.81|||ANCOVA||||
1674070|NCT01333501|3079193|Superiority or Other||Mean Difference (Net)|0.17|Standard Error of the Mean|0.47||0.7119|2-Sided|95.0|-0.76|1.11|||ANCOVA||||
1674071|NCT01333501|3079194|Superiority or Other||Mean Difference (Net)|0.37|Standard Error of the Mean|2.53||0.8858|2-Sided|95.0|-4.67|5.4|||ANCOVA||||
1674072|NCT01333501|3079195|Superiority or Other||Mean Difference (Net)|0.46|Standard Error of the Mean|2.53||0.8561|2-Sided|95.0|-4.57|5.49|||ANCOVA||||
1674073|NCT01333501|3079196|Superiority or Other||Mean Difference (Net)|-1.73|Standard Error of the Mean|2.29||0.4501|2-Sided|95.0|-6.27|2.81|||ANCOVA||||
1674074|NCT01333501|3079197|Superiority or Other||Mean Difference (Net)|-1.6|Standard Error of the Mean|1.05||0.1334|2-Sided|95.0|-3.69|0.5|||ANCOVA||||
1674075|NCT01333501|3079198|Superiority or Other||Mean Difference (Net)|1.97|Standard Error of the Mean|3.03||0.5183|2-Sided|95.0|-4.06|7.99|||ANCOVA||||
1674096|NCT01333189|3079229|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Internal moment at the ankle|
1674097|NCT01333189|3079229|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Internal moment at the knee|
1674098|NCT01333189|3079229|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Internal moment at the hip|
1674099|NCT01333189|3079230|Superiority or Other||||||=|0|||||||Mixed Models Analysis||||
1674100|NCT01333189|3079231|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Internal moment at the ankle|
1674101|NCT01333189|3079231|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Internal moment at the knee|
1674102|NCT01333189|3079231|Superiority or Other||||||=|0|||||||Mixed Models Analysis|||Internal moment at the hip|
1674103|NCT01333189|3079232|Superiority or Other||||||=|0|||||||Mixed Models Analysis||||
1674104|NCT01333189|3079233|Superiority or Other||||||=|0|||||||Mixed Models Analysis||||
1674105|NCT01333189|3079234|Superiority or Other||||||=|0|||||||Mixed Models Analysis||||
1674106|NCT01332994|3079269|Superiority or Other|||||||0.3848|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 66, Plasmablasts|
1674107|NCT01332994|3079269|Superiority or Other||||||<|0.0001|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 66, Double-negative B-cells|
1674108|NCT01332994|3079269|Superiority or Other||||||<|0.7244|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 66, IgA-positive class-switched B-cells|
1674109|NCT01332994|3079269|Superiority or Other||||||<|0.8413|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 66, IgG-positive class-switched B-cells|
1674110|NCT01332994|3079269|Superiority or Other||||||<|0.6515|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 66, Post-switch memory B-cells|
1674111|NCT01332994|3079269|Superiority or Other||||||<|0.9338|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 66, Pre-switch memory B-cells|
1674112|NCT01332994|3079269|Superiority or Other||||||<|0.0001|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 66, Memory B-cells|
1674113|NCT01332994|3079269|Superiority or Other||||||<|0.9074|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 66, Naive B-cells|
1674114|NCT01332994|3079269|Superiority or Other||||||<|0.9338|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 66, Transitional B-cells|
1674115|NCT01332994|3079269|Superiority or Other||||||<|0.7261|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 66, Naive B-cell compartment|
1674116|NCT01332994|3079269|Superiority or Other||||||<|0.8729|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 48, Plasmablasts|
1674117|NCT01332994|3079269|Superiority or Other||||||<|0.391|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 48, IgA-positive class-switched B-cells|
1674118|NCT01332994|3079269|Superiority or Other||||||<|0.7471|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 48, IgG-positive class-switched B-cells|
1674119|NCT01332994|3079269|Superiority or Other||||||<|0.7471|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 48, Post-switch memory B-cells|
1674120|NCT01332994|3079269|Superiority or Other||||||<|0.2848|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 48, Pre-switch memory B-cells|
1674121|NCT01332994|3079269|Superiority or Other||||||<|0.6238|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 48, Naive B-cells|
1674122|NCT01332994|3079269|Superiority or Other||||||<|0.2848|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 48, Transitional B-cells|
1674123|NCT01332994|3079269|Superiority or Other||||||<|0.6238|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 48, Naive B-cell compartment|
1674124|NCT01332994|3079269|Superiority or Other||||||<|0.5377|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Plasmablasts|
1674125|NCT01332994|3079269|Superiority or Other||||||<|0.7872|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Double-negative B-cells|
1674126|NCT01332994|3079269|Superiority or Other||||||<|0.2011|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, IgA-positive class-switched B-cells|
1674200|NCT01332500|3079376|Superiority or Other|||||||0.392||||||Ergot tablets|paired t-test 2-sided||||
1674127|NCT01332994|3079269|Superiority or Other||||||<|0.7266|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, IgG-positive class-switched B-cells|
1674128|NCT01332994|3079269|Superiority or Other||||||<|0.8526|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Post-switch memory B-cells|
1674129|NCT01332994|3079269|Superiority or Other||||||<|0.4778|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Pre-switch memory B-cells|
1674130|NCT01332994|3079269|Superiority or Other||||||<|0.208|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Memory B-cells|
1674131|NCT01332994|3079269|Superiority or Other||||||<|0.9678|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Naive B-cells|
1674132|NCT01332994|3079269|Superiority or Other||||||<|0.6905|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Transitional B-cells|
1674133|NCT01332994|3079269|Superiority or Other||||||<|0.6551|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Naive B-cell compartment|
1674134|NCT01332994|3079270|Superiority or Other|||||||0.7695|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 32, Plasmablasts|
1674135|NCT01332994|3079270|Superiority or Other|||||||0.5546|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 32, Double-negative B-cells|
1674136|NCT01332994|3079270|Superiority or Other|||||||0.4196|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 32, IgA-positive class-switched B-cells|
1674137|NCT01332994|3079270|Superiority or Other|||||||0.3934|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 32, IgG-positive class-switched B-cells|
1674138|NCT01332994|3079270|Superiority or Other|||||||0.4353|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 32, Post-switch memory B-cells|
1674139|NCT01332994|3079270|Superiority or Other|||||||0.1019|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 32, Pre-switch memory B-cells|
1674140|NCT01332994|3079270|Superiority or Other|||||||0.6199|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 32, Memory B-cells|
1674141|NCT01332994|3079270|Superiority or Other|||||||0.1386|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 32, Naive B-cells|
1674142|NCT01332994|3079270|Superiority or Other|||||||0.2189|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 32, Transitional B-cells|
1674143|NCT01332994|3079270|Superiority or Other|||||||0.0919|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 32, Naive B-cell compartment|
1674144|NCT01332994|3079270|Superiority or Other|||||||0.3449|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 24, Plasmablasts|
1674145|NCT01332994|3079270|Superiority or Other|||||||0.6304|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 24, Double-negative B-cells|
1674146|NCT01332994|3079270|Superiority or Other|||||||0.1626|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 24, IgA-positive class-switched B-cells|
1674147|NCT01332994|3079270|Superiority or Other|||||||0.1746|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 24, IgG-positive class-switched B-cells|
1674148|NCT01332994|3079270|Superiority or Other|||||||0.1714|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 24, Post-switch memory B-cells|
1674149|NCT01332994|3079270|Superiority or Other|||||||0.3071|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 24, Pre-switch memory B-cells|
1674150|NCT01332994|3079270|Superiority or Other|||||||0.1919|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 24, Memory B-cells|
1674151|NCT01332994|3079270|Superiority or Other|||||||0.0463|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 24, Naive B-cells|
1674152|NCT01332994|3079270|Superiority or Other|||||||0.005|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 24, Transitional B-cells|
1674153|NCT01332994|3079270|Superiority or Other|||||||0.0186|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 24, Naive B-cell compartment|
1674154|NCT01332994|3079270|Superiority or Other|||||||0.0639|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Plasmablasts|
1674155|NCT01332994|3079270|Superiority or Other|||||||0.7108|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Double-negative B-cells|
1674156|NCT01332994|3079270|Superiority or Other|||||||0.3623|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, IgA-positive class-switched B-cells|
1674157|NCT01332994|3079270|Superiority or Other|||||||0.3817|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, IgG-positive class-switched B-cells|
1674158|NCT01332994|3079270|Superiority or Other|||||||0.5595|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Post-switch memory B-cells|
1674159|NCT01332994|3079270|Superiority or Other|||||||0.7912|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Pre-switch memory B-cells|
1674160|NCT01332994|3079270|Superiority or Other|||||||0.7671|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Memory B-cells|
1674161|NCT01332994|3079270|Superiority or Other|||||||0.7435|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Naive B-cells|
1674162|NCT01332994|3079270|Superiority or Other|||||||0.3596|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Transitional B-cells|
1674163|NCT01332994|3079270|Superiority or Other|||||||0.9993|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Week 16, Naive B-cell compartment|
1674164|NCT01332994|3079271|Superiority or Other|||||||0.9564|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Plasmablasts|
1674165|NCT01332994|3079271|Superiority or Other|||||||0.8693|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Double-negative B-cells|
1674166|NCT01332994|3079271|Superiority or Other|||||||0.886|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||IgA-positive class-switched B-cells|
1674167|NCT01332994|3079271|Superiority or Other|||||||0.2215|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||IgG-positive class-switched B-cells|
1674168|NCT01332994|3079271|Superiority or Other|||||||0.4553|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Post-switch memory B-cells|
1674169|NCT01332994|3079271|Superiority or Other|||||||0.6574|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Pre-switch memory B-cells|
1674170|NCT01332994|3079271|Superiority or Other|||||||0.8081|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Memory B-cells|
1674171|NCT01332994|3079271|Superiority or Other|||||||0.7915|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Naive B-cells|
1674172|NCT01332994|3079271|Superiority or Other|||||||0.8961|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Transitional B-cells|
1674173|NCT01332994|3079271|Superiority or Other|||||||0.7559|||||||Spearman Rank-Order Correlation|Probability values for the Spearman correlation were calculated as [square root of (n minus 2) x [square root of (r^2 divided by 1 minus r^2)].||Naive B-cell compartment|
1674174|NCT01332994|3079307|Superiority or Other|||||||0.1648||||||Exact one-sided binomial test on single proportions with a significance level of alpha equals (=) 0.025. Null hypothesis: Proportion of participants reaching DAS28 remission (<2.6) at Week 16 is ≤45 percent (%).|Exact one-sided binomial test||||
1674175|NCT01332968|3079343|Superiority or Other (legacy)||Hazard Ratio (HR)|0.66||||0.0012|2-Sided|95.0|0.51|0.85|||Log Rank|Stratified by chemotherapy regimen and Follicular Lymphoma International Prognostic Index (FLIPI) risk group.|||
1674176|NCT01332851|3079348|Superiority||Mean Difference (Net)|-0.07|Standard Error of the Mean|0.04|<|0.05|2-Sided||||||Mixed Models Analysis||The PFR group had lower atypical affective communication compared to the R&R group (the absolute value of the standardized effect size was d=.19).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R&R = 0, PFR = 1), baseline score, months between baseline and end of intervention, and age of child at baseline|
1674177|NCT01332851|3079349|Superiority||Mean Difference (Net)|-0.06|Standard Error of the Mean|0.08|>|0.05|2-Sided||||||Regression, Linear||Adjusted mean at 3-month post-intervention was -.06 (SE=.08) lower for PFR compared to R&R group.||
1674178|NCT01332851|3079350|Superiority||Mean Difference (Net)|-0.07|Standard Error of the Mean|0.08|>|0.05|2-Sided||||||Regression, Linear||Adjusted mean at 3-month post-intervention was -.07 (SE=.08) lower for PFR compared to R&R group.|Tested mean differences by condition at 3-month follow-up controlling for baseline score, months between baseline and the end of the intervention, and age of child and using an ANVOVA/regression model. Null hypothesis was that post-intervention means were equal.|
1674179|NCT01332851|3079351|Superiority||Mean Difference (Net)|-0.8|Standard Error of the Mean|0.66|>|0.05|2-Sided||||||Mixed Models Analysis||The PFR group had lower mean level of problem behavior compared to the R&R group (the absolute value of standardized effect is d= .12).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R&R = 0, PFR = 1), baseline problem behavior score, months between baseline and end of intervention, and age of child at baseline|
1674180|NCT01332851|3079352|Superiority||Mean Difference (Net)|0.24|Standard Error of the Mean|0.25|>|0.05|2-Sided||||||Mixed Models Analysis||The PFR group had a higher mean level of social and emotional development compared to the R&R group (the absolute value of the standardized effect is d=.10).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R&R = 0, PFR = 1), baseline social-emotional competence score, months between baseline and end of intervention, and age of child at baseline.|
1674181|NCT01332851|3079353|Superiority||Mean Difference (Net)|0.41|Standard Error of the Mean|0.53|>|0.05|2-Sided||||||Mixed Models Analysis||The adjusted mean across post-intervention time points was .41 (SE=.53) higher in the PFR group than the R&R group. The standardized effect size was d=-.07|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R&R = 0, PFR = 1), baseline competence stress score, months between baseline and end of intervention, and age of child at baseline|
1674182|NCT01332851|3079354|Superiority||Mean Difference (Net)|-0.2|Standard Error of the Mean|0.5|>|0.05|2-Sided||||||Mixed Models Analysis||The adjusted mean across the two post-intervention time points was -.20 (SE=.50) lower in the PFR group than R&R group. The standardized effect size was d=.04.|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R&R = 0, PFR = 1), baseline problem behavior score, months between baseline and end of intervention, and age of child at baseline.|
1674183|NCT01332851|3079355|Superiority||Mean Difference (Net)|0.05|Standard Error of the Mean|0.03|>|0.05|2-Sided||||||Mixed Models Analysis||The PFR group had a higher mean compared to the R&R group. (the absolute value of the standardized effect is d=.15).|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R&R = 0, PFR = 1), baseline security score, months between baseline and end of intervention, and age of child at baseline|
1674184|NCT01332851|3079356|Superiority or Other||Mean Difference (Net)|0.94|Standard Error of the Mean|0.42|<|0.05|2-Sided||||||Mixed Models Analysis||Parents in the PFR condition were 0.94 higher on sensitivity scores (on the unstandardized sensitivity measure) across the three post-intervention time points than parents in the R&R condition. The standard error (SE) of this difference was .42.|Mixed models were estimated in which post-intervention scores were nested. The intercept (representing the average score across post-intervention time points) was modeled as having a random effect. The intercept in the mixed model was regressed on intervention condition (R&R = 0, PFR = 1), baseline sensitivity score, months between baseline and end of intervention, and age of child at baseline.|
1674185|NCT01332851|3079357|Superiority||Cox Proportional Hazard|2.5|||=|0|2-Sided|95.0|1.03|6.1||We used a threshold of p < .05 as the criterion for statistical significance.|Regression, Cox||The hazard ratio of 2.5 indicates that children with parents in the control group were 2.5 times more likely to be removed from their home and placed into foster care compared to the intervention group.|Child welfare system removals were analyzed with a survival models that used condition assignment to predict hazard of being removed from the birth parent home.|
1674186|NCT01332578|3079373|Superiority or Other||Median Difference (Final Values)|-20.92||||0.0004|2-Sided|95.0|-27.31|-15.81|||Wilcoxon (Mann-Whitney)||Hodges-Lehmann estimate of median difference was determined.|Null hypothesis was no difference between test hot drink and standard paracetamol tablets.|
1674187|NCT01332500|3079374|Superiority or Other|||||||0.001||||||Total health plus copay costs|paired t-test 2-sided||||
1674188|NCT01332500|3079374|Superiority or Other|||||||0.514||||||Other health plus copay costs|paired t-test 2-sided||||
1674189|NCT01332500|3079374|Superiority or Other|||||||0.354||||||Ergot health plus copay costs|paired t-test 2-sided||||
1674190|NCT01332500|3079374|Superiority or Other|||||||0.826||||||Opioid health plus copay costs|paired t-test 2-sided||||
1674191|NCT01332500|3079374|Superiority or Other|||||||0.146||||||Non-steroidal anti-inflammatory drug health plus copay costs|paired t-test 2-sided||||
1674192|NCT01332500|3079374|Superiority or Other||||||<|0.001||||||Triptan health plus copay costs|paired t-test 2-sided||||
1674193|NCT01332500|3079375|Superiority or Other||||||<|0.001||||||Total health plan costs|paired t-test 2-sided||||
1674194|NCT01332500|3079375|Superiority or Other||||||<|0.343||||||Other health plan costs|paired t-test 2-sided||||
1674195|NCT01332500|3079375|Superiority or Other||||||<|0.382||||||Ergot health plan costs|paired t-test 2-sided||||
1674196|NCT01332500|3079375|Superiority or Other||||||<|0.59||||||Opioid health plan costs|paired t-test 2-sided||||
1674197|NCT01332500|3079375|Superiority or Other||||||<|0.054||||||Non-steroidal anti-inflammatory drug health plan costs|paired t-test 2-sided||||
1674198|NCT01332500|3079375|Superiority or Other||||||<|0.001||||||Triptan health plan costs|paired t-test 2-sided||||
1674199|NCT01332500|3079376|Superiority or Other|||||||0.752||||||Other tablets|paired t-test 2-sided||||
1674201|NCT01332500|3079376|Superiority or Other|||||||0.832||||||Opioid tablets|paired t-test 2-sided||||
1674202|NCT01332500|3079376|Superiority or Other|||||||0.094||||||Non-steroidal anti-inflammatory drug tablets|paired t-test 2-sided||||
1674203|NCT01332500|3079376|Superiority or Other|||||||0.866||||||Triptan tablets|paired t-test 2-sided||||
1674204|NCT01332500|3079377|Superiority or Other||||||<|0.001||||||Total health plus copay costs|paired t-test 2-sided||||
1674205|NCT01332500|3079377|Superiority or Other||||||<|0.254||||||Other health plus copay costs|paired t-test 2-sided||||
1674206|NCT01332500|3079377|Superiority or Other||||||<|0.191||||||Ergot health plus copay costs|paired t-test 2-sided||||
1674207|NCT01332500|3079377|Superiority or Other||||||<|0.173||||||Opioid health plus copay costs|paired t-test 2-sided||||
1674208|NCT01332500|3079377|Superiority or Other||||||<|0.177||||||Non-steroidal, anti-inflammatory drug health plus copay costs|paired t-test 2-sided||||
1674209|NCT01332500|3079377|Superiority or Other||||||<|0.001||||||Triptan health plus copay costs|paired t-test 2-sided||||
1674210|NCT01332500|3079378|Superiority or Other||||||<|0.001||||||Total heath plan costs|paired t-test 2-sided||||
1674211|NCT01332500|3079378|Superiority or Other||||||<|0.583||||||Other health plan costs|paired t-test 2-sided||||
1674212|NCT01332500|3079378|Superiority or Other||||||<|0.239||||||Ergot health plan costs|paired t-test 2-sided||||
1674213|NCT01332500|3079378|Superiority or Other||||||<|0.208||||||Opioid health plan costs|paired t-test 2-sided||||
1674214|NCT01332500|3079378|Superiority or Other||||||<|0.349||||||Non-steroidal anti-inflammatory drug health plan costs|paired t-test 2-sided||||
1674215|NCT01332500|3079378|Superiority or Other||||||<|0.001||||||Triptan health plan costs|paired t-test 2-sided||||
1674216|NCT01332500|3079379|Superiority or Other|||||||0.162||||||Other tablets|paired t-test 2-sided||||
1674217|NCT01332500|3079379|Superiority or Other|||||||0.336||||||Ergot tablets|paired t-test 2-sided||||
1674218|NCT01332500|3079379|Superiority or Other|||||||0.005||||||Opioid tablets|paired t-test 2-sided||||
1674219|NCT01332500|3079379|Superiority or Other||||||<|0.001||||||Non-steroidal anti-inflammatory drug tablets|paired t-test 2-sided||||
1674220|NCT01332500|3079379|Superiority or Other||||||<|0.001||||||Triptan tablets|paired t-test 2-sided||||
1674221|NCT01332487|3079381|Superiority or Other|||||||0.597||||||Emergency Surgery|Chi-squared||||
1674222|NCT01332487|3079381|Superiority or Other|||||||0||||||Surgery|Chi-squared||||
1674223|NCT01332487|3079381|Superiority or Other|||||||0.002||||||Acute Urinary Retention|Chi-squared||||
1674224|NCT01332461|3079383|Superiority or Other||Hazard Ratio (HR)|0.785|||<|0.05|2-Sided|95.0|0.649|0.948||COPD-related hospitalization/ER visit/physician+Rx|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.||
1674225|NCT01332461|3079383|Superiority or Other||Hazard Ratio (HR)|0.815|||<|0.05|2-Sided|95.0|0.658|1.008||COPD-related physician + Rx visit|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.||
1674226|NCT01332461|3079383|Superiority or Other||Hazard Ratio (HR)|0.651|||<|0.05|2-Sided|95.0|0.434|0.977||COPD-related ER visit|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.||
1674227|NCT01332461|3079383|Superiority or Other||Hazard Ratio (HR)|0.601|||<|0.05|2-Sided|95.0|0.326|1.109||COPD-related hospitalization|Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.||
1674228|NCT01332461|3079384|Superiority or Other||Hazard Ratio (HR)|0.649||||0.05|2-Sided|95.0|0.455|0.926|||Log Rank||Covariates for risk models included Charlson Comorbidity Index, presence of asthma, number and quantity of rescue and controller medications, oxygen, and number of COPD healthcare resource use.||
1674229|NCT01332435|3079386|Superiority or Other||||||<|0.001|||||||Regression, Linear||||
1674230|NCT01332435|3079386|Superiority or Other||||||<|0.001|||||||Regression, Linear||||
1674231|NCT01332435|3079387|Superiority or Other|||||||0.8645|||||||Regression, Linear||||
1674232|NCT01332435|3079387|Superiority or Other||||||<|0.001|||||||Regression, Linear||||
1674233|NCT01332435|3079388|Superiority or Other|||||||0.0699|||||||Chi-squared||||
1674234|NCT01332435|3079388|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1674235|NCT01332435|3079389|Superiority or Other|||||||0.0006|||||||Chi-squared||||
1674236|NCT01332435|3079389|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1674237|NCT01332435|3079390|Superiority or Other|||||||0.0002|||||||Chi-squared||||
1674238|NCT01332435|3079390|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1674239|NCT01332357|3079391|Superiority or Other||Hazard Ratio (HR)|1.008|||<|0.0001|2-Sided|95.0|1.005|1.011||The risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge by time interaction|Regression, Cox|Evaluates the impact of each day treatment with a controller was delayed|||
1674240|NCT01332357|3079391|Superiority or Other||Hazard Ratio (HR)|1.79|||<|0.0001|2-Sided|95.0|1.42|2.25||The adjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge|Regression, Cox|Covariates included demographics, IP or ED index event, primary asthma diagnosis, Charlson score, and pre-index medication|||
1674241|NCT01332357|3079391|Superiority or Other||Hazard Ratio (HR)|1.96|||<|0.0001|2-Sided|95.0|1.56|2.46||The unadjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge|Regression, Cox||||
1674242|NCT01332318|3079441|Superiority or Other||Least Squares Mean Difference|0.16|Standard Error of the Mean|0.06||||95.0|0.09|0.42|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 4 minus Arm 1.||
1674243|NCT01332318|3079441|Superiority or Other||Least Squares Mean Difference|0.15|Standard Error of the Mean|0.06||||95.0|0.09|0.41|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 3 minus Arm 1.||
1674244|NCT01332318|3079441|Superiority or Other||Least Squares Mean Difference|0.15|Standard Error of the Mean|0.06||||95.0|0.08|0.42|||||An Analysis of Covariance (ANCOVA) model, including terms for treatment, pooled study site, visit, and treatment by visit interaction, was used to calculate the adjusted mean difference and confidence interval. Arm 2 minus Arm 1.||
1674245|NCT01332149|3079528|Superiority or Other||LS Mean Difference|-0.19|Standard Error of the Mean|0.218||0.3724|2-Sided|95.0|-0.62|0.23||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.|||
1674246|NCT01332149|3079529|Superiority or Other||LS Mean Difference|-0.17|Standard Error of the Mean|0.207||0.4172|2-Sided|95.0|-0.57|0.24||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.|||
1674247|NCT01332149|3079531|Superiority or Other||LS Mean Difference|-0.14|Standard Error of the Mean|0.074||0.0602|2-Sided|95.0|-0.28|0.01||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis performed using a general linear model with treatment and center as factors.|
1674248|NCT01332149|3079532|Superiority or Other||LS Mean Difference|-0.15|Standard Error of the Mean|0.073||0.0431|2-Sided|95.0|-0.29|0.0||Analysis was two-sided and performed at the 0.05 significance level.|ANOVA|||Analysis performed using a general linear model with treatment and center as factors.|
1674249|NCT01332149|3079533|Superiority or Other||LS Mean Difference|-0.83|Standard Error of the Mean|1.177||0.4829|2-Sided|95.0|-3.14|1.49||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.|||
1674250|NCT01332149|3079534|Superiority or Other||LS Mean Difference|-0.35|Standard Error of the Mean|1.536||0.8216|2-Sided|95.0|-3.36|2.67||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.|||
1674251|NCT01332149|3079535|Superiority or Other||LS Mean Difference|1.05|Standard Error of the Mean|1.973||0.596|2-Sided|95.0|-2.83|4.92||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.|||
1674252|NCT01332149|3079536|Superiority or Other||Odds Ratio (OR)|1.05||||0.7929|2-Sided|95.0|0.72|1.53||Analysis was two-sided and performed at the 0.05 significance level.|Regression, Logistic|||Analysis performed using a logistic regression model with treatment and center as factors, and baseline value as a covariate.|
1674253|NCT01332149|3079537|Superiority or Other||LS Mean Difference|0.19|Standard Error of the Mean|0.11||0.0887|2-Sided|95.0|-0.03|0.4||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.|||
1674254|NCT01332149|3079538|Superiority or Other||LS Mean Difference|0.21|Standard Error of the Mean|1.371||0.8808|2-Sided|95.0|-2.49|2.9||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.|||
1674255|NCT01332149|3079539|Superiority or Other||LS Mean Difference|3.31|Standard Error of the Mean|2.22||0.1363|2-Sided|95.0|-1.05|7.67||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.|||
1674256|NCT01332149|3079540|Superiority or Other||LS Mean Difference|-1.13|Standard Error of the Mean|1.577||0.4758|2-Sided|95.0|-4.22|1.97||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.|||
1674257|NCT01332149|3079542|Superiority or Other||LS Mean Difference|-0.07|Standard Error of the Mean|0.061||0.2748|2-Sided|95.0|-0.19|0.05||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.|||
1674258|NCT01332149|3079543|Superiority or Other||LS Mean Difference|-3.25|Standard Error of the Mean|1.628||0.0463|2-Sided|95.0|-6.45|-0.05||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.|||
1674259|NCT01332149|3079546|Superiority or Other||Odds Ratio (OR)|1.27||||0.1309|2-Sided|95.0|0.93|1.74||Analysis was two-sided and performed at the 0.05 significance level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test comparing pregabalin to placebo adjusted for center.|||
1674260|NCT01332149|3079547|Superiority or Other||LS Mean Difference|-0.18|Standard Error of the Mean|0.11||0.1006|2-Sided|95.0|-0.4|0.04||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674261|NCT01332149|3079547|Superiority or Other||LS Mean Difference|-0.18|Standard Error of the Mean|0.13||0.1651|2-Sided|95.0|-0.43|0.07||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674262|NCT01332149|3079547|Superiority or Other||LS Mean Difference|-0.23|Standard Error of the Mean|0.13||0.077|2-Sided|95.0|-0.48|0.02||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1675538|NCT01309360|3082375|Superiority or Other|||||||1|||||||Fisher Exact||||
1674263|NCT01332149|3079547|Superiority or Other||LS Mean Difference|-0.18|Standard Error of the Mean|0.13||0.1628|2-Sided|95.0|-0.44|0.07||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674264|NCT01332149|3079547|Superiority or Other||LS Mean Difference|-0.25|Standard Error of the Mean|0.129||0.0531|2-Sided|95.0|-0.5|0.0||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674265|NCT01332149|3079547|Superiority or Other||LS Mean Difference|-0.16|Standard Error of the Mean|0.129||0.2095|2-Sided|95.0|-0.41|0.09||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674266|NCT01332149|3079547|Superiority or Other||LS Mean Difference|-0.21|Standard Error of the Mean|0.129||0.1094|2-Sided|95.0|-0.46|0.05||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674267|NCT01332149|3079547|Superiority or Other||LS Mean Difference|-0.16|Standard Error of the Mean|0.129||0.2249|2-Sided|95.0|-0.41|0.1||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674268|NCT01332149|3079547|Superiority or Other||LS Mean Difference|-0.15|Standard Error of the Mean|0.128||0.2482|2-Sided|95.0|-0.4|0.1||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674269|NCT01332149|3079547|Superiority or Other||LS Mean Difference|-0.12|Standard Error of the Mean|0.127||0.3438|2-Sided|95.0|-0.37|0.13||Analysis was two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674270|NCT01332149|3079548|Superiority or Other||LS Mean Difference|-0.21|Standard Error of the Mean|0.143||0.134|2-Sided|95.0|-0.49|0.07||Analysis was two-sided and performed at the 0.05 significance level.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.|||
1674271|NCT01332149|3079550|Superiority or Other||LS Mean Difference|-0.25|Standard Error of the Mean|0.105||0.0164|2-Sided|95.0|-0.46|-0.05||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis||Overall change was estimated from the mixed effect model treatment main effect.|Overall change from baseline analysis. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674272|NCT01332149|3079550|Superiority or Other||LS Mean Difference|-0.25|Standard Error of the Mean|0.122||0.0375|2-Sided|95.0|-0.49|-0.01||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 9 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674273|NCT01332149|3079550|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.122||0.014|2-Sided|95.0|-0.54|-0.06||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 8 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674274|NCT01332149|3079550|Superiority or Other||LS Mean Difference|-0.27|Standard Error of the Mean|0.122||0.028|2-Sided|95.0|-0.51|-0.03||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 7 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674275|NCT01332149|3079550|Superiority or Other||LS Mean Difference|-0.24|Standard Error of the Mean|0.122||0.0469|2-Sided|95.0|-0.48|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 6 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674276|NCT01332149|3079550|Superiority or Other||LS Mean Difference|-0.22|Standard Error of the Mean|0.122||0.0672|2-Sided|95.0|-0.46|0.02||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 5 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674277|NCT01332149|3079550|Superiority or Other||LS Mean Difference|-0.26|Standard Error of the Mean|0.121||0.0349|2-Sided|95.0|-0.49|-0.02||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 4 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674416|NCT01328951|3079898|Superiority or Other||Difference in Response Rate|1.99||||0.6062|2-Sided|95.0|-5.74|9.72|||Chi-squared||The 95% CI for difference in response rates was constructed using the Anderson-Hauck method.||
1674278|NCT01332149|3079550|Superiority or Other||LS Mean Difference|-0.24|Standard Error of the Mean|0.121||0.0508|2-Sided|95.0|-0.48|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 3 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674279|NCT01332149|3079550|Superiority or Other||LS Mean Difference|-0.27|Standard Error of the Mean|0.121||0.0279|2-Sided|95.0|-0.5|-0.03||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 2 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674280|NCT01332149|3079550|Superiority or Other||LS Mean Difference|-0.23|Standard Error of the Mean|0.12||0.0527|2-Sided|95.0|-0.47|0.0||All analyses were two-sided and performed at the 0.05 significance level.|Mixed Model Repeated Measures Analysis|||Week 1 Modelled Results. The model used was a linear mixed model with treatment, week, center, and treatment by week interaction as factors, and the baseline value as a covariate. A compound symmetry covariance structure is specified.|
1674281|NCT01332149|3079551|Superiority or Other||Least Squares (LS) Mean Difference|-0.28|Standard Error of the Mean|0.148||0.0559|2-Sided|95.0|-0.58|0.01||Primary analysis was two-sided and performed at the 0.05 significance level. No multiple comparisons adjustment was made.|ANCOVA|The ANCOVA model included treatment and study center as factors and the corresponding baseline score as a covariate in the model.|||
1674282|NCT01332071|3079555|Non-Inferiority or Equivalence|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency – ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|97.88|||||2-Sided|90.0|93.15|102.86|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.||
1674283|NCT01332071|3079556|Non-Inferiority or Equivalence|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency – ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|94.86|||||2-Sided|90.0|90.7|99.22|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.||
1674284|NCT01332071|3079557|Non-Inferiority or Equivalence|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency – ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|95.79|||||2-Sided|90.0|91.67|100.1|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.||
1674285|NCT01332071|3079558|Non-Inferiority or Equivalence|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency – ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|96.47|||||2-Sided|90.0|93.32|99.72|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.||
1674286|NCT01332071|3079559|Non-Inferiority or Equivalence|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency – ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|97.76|||||2-Sided|90.0|93.25|102.5|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.||
1674287|NCT01332071|3079560|Non-Inferiority or Equivalence|This is a bioequivalence study. The study was performed to fulfill a specific regulatory demand of the Brazilian Regulatory Agency – ANVISA, in order to register a new dosage of medication.|Ratio T formulation/R formulation|96.58|||||2-Sided|90.0|93.44|99.83|||||The ratio between the geometric means of the test (T) and reference (R) formulations was calculated.||
1674288|NCT01332019|3079583|Superiority or Other||Cox Proportional Hazard|0.57||||0.006|2-Sided|95.0|0.38|0.85||Based on Cox Proportional Hazards model, adjusted for 105MS302 baseline EDSS and age (<40 vs >=40).|Cox Proportional Hazards model||q2w/q4w||
1674289|NCT01332019|3079589|Superiority or Other|||||||0.0026||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of Gd-enhancing lesion.|Regression, Logistic|||Week 96|
1674290|NCT01332019|3079589|Superiority or Other|||||||0.0012||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of Gd-enhancing lesion.|Regression, Logistic|||Week 48|
1674291|NCT01332019|3079590|Superiority or Other||||||<|0.0001||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of T1 lesions.|Regression, Logistic|||Week 96|
1674292|NCT01332019|3079590|Superiority or Other||||||<|0.0001||||||p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on multiple logit regression, adjusted for 302 baseline number of T1 lesions.|Regression, Logistic|||Week 48|
1674293|NCT01332019|3079591|Superiority or Other||lesion mean ratio|0.55|||<|0.0001|2-Sided|95.0|0.43|0.71||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of Gd lesions.|negative binomial regression|||Week 96|
1674294|NCT01332019|3079591|Superiority or Other||lesion mean ratio|0.54|||<|0.0001|2-Sided|95.0|0.43|0.68||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of Gd lesions.|negative binomial regression|||Week 48|
1674295|NCT01332019|3079592|Superiority or Other||lesion mean ratio|0.49|||<|0.0001|2-Sided|95.0|0.39|0.62||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 302 baseline number of T2 lesions.|negative binomial regression|||Week 96|
1674296|NCT01332019|3079592|Superiority or Other||lesion mean ratio|0.51|||<|0.0001|2-Sided|95.0|0.41|0.63||Lesion mean ratio (95% CI) and p-value for comparison between the every 2 weeks group and the every 4 weeks group, based on negative binomial regression, adjusted for 105MS302 baseline number of T2 lesions.|negative binomial regression|||Week 48|
1674417|NCT01328951|3079900|Superiority or Other||Odds Ratio (OR)|1.8|||||2-Sided|95.0|0.87|3.72|||||The 95% CI for OR was constructed using the Wald method.||
1674297|NCT01332019|3079593|Superiority or Other||Hazard Ratio (HR)|0.75||||0.0201|2-Sided|95.0|0.59|0.96||Based on Cox proportion hazards model, adjusted for EDSS (<4 vs >= 4), age (<40 vs >=40), relapse rate (based on one year before 105MS301 and 105MS301), and gadolinium (Gd) enhancing lesions (presence vs. absence) at 105MS302 baseline.|Cox proportion hazards model|||q2w/q4w|
1674298|NCT01332019|3079594|Superiority or Other||rate ratio|0.755||||0.0203|2-Sided|95.0|0.595|0.957||q2w/q4w|negative binomial regression|||Based on negative binomial regression for each treatment group, with adjustment for EDSS (<4 vs. >=4), relapse rate (based on 1 year before 105MS301 and 105MS301), and age (<40 vs. >=40) at 105MS302 baseline.|
1674299|NCT01331837|3079601|Non-Inferiority or Equivalence|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|0.99|||||2-Sided|95.0|0.7|1.41||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~Previous exposure to anti-TNF (Yes/No)~History of CV events (Yes/No)"|
1674300|NCT01331837|3079603|Non-Inferiority or Equivalence|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|1.53|||||2-Sided|95.0|0.8|2.92||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~Previous exposure to anti-TNF (Yes/No)~History of CV events (Yes/No)"|
1674301|NCT01331837|3079605|Non-Inferiority or Equivalence|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|1.03|||||2-Sided|95.0|0.64|1.63||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~Previous exposure to anti-TNF (Yes/No)~History of CV events (Yes/No)"|
1674302|NCT01331837|3079607|Non-Inferiority or Equivalence|'The non-inferiority margin was only formally tested for the primary ITT analysis'|Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.54|1.49||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~Previous exposure to anti-TNF (Yes/No)~History of CV events (Yes/No)"|
1674303|NCT01331837|3079609|Non-Inferiority or Equivalence|The non-inferiority margin was only formally tested for the primary ITT analysis.|Hazard Ratio (HR)|0.99|||||2-Sided|95.0|0.73|1.34||||||"The analysis assessed in the ITT population the hazard ratio of the secondary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~Previous exposure to anti-TNF (Yes/No)~History of CV events (Yes/No)"|
1674304|NCT01331837|3079611|Non-Inferiority or Equivalence|The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.|Hazard Ratio (HR)|1.04|||||2-Sided|95.0|0.7|1.56||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~Previous exposure to anti-TNF (Yes/No)~History of CV events (Yes/No)"|
1674305|NCT01331837|3079613|Non-Inferiority or Equivalence|The non-inferiority margin was only formally tested for the primary ITT analysis and not for the sensitivity analysis.|Hazard Ratio (HR)|1.01|||||2-Sided|95.0|0.73|1.4||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~Previous exposure to anti-TNF (Yes/No)~History of CV events (Yes/No)"|
1674306|NCT01331837|3079615|Non-Inferiority or Equivalence|The non-inferiority margin was only formally tested for the primary ITT analysis'|Hazard Ratio (HR)|1.11|||||2-Sided|95.0|0.76|1.62||||||"The analysis assessed in the OT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~Previous exposure to anti-TNF (Yes/No)~History of CV events (Yes/No)"|
1674307|NCT01331837|3079617|Non-Inferiority or Equivalence|In order to reject the null hypothesis and claim non-inferiority of TCZ compared to ETA, a HR point estimate of ≤ 1.278 and upper limit of 95% CI <1.8 was required.|Hazard Ratio (HR)|1.05|||||2-Sided|95.0|0.77|1.43||||||"The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients.~A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata:~Previous exposure to anti-TNF (Yes/No)~History of CV events (Yes/No)"|
1674308|NCT01331694|3079623|Superiority or Other||Hazard Ratio (HR)|1.33||||||95.0|1.17|1.51|||||Hazard ratio for outpatient visit with antibiotic fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization||
1674309|NCT01331694|3079623|Superiority or Other||Hazard Ratio (HR)|1.39||||||95.0|1.23|1.57|||||Hazard ratio for outpatient visit with antibiotic fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization||
1674418|NCT01328951|3079900|Superiority or Other||Difference in Response Rate|2.78||||0.1097|2-Sided|95.0|-0.78|6.35|||Chi-squared||The 95% CI for difference in response rates was constructed using the Anderson-Hauck method.||
1674310|NCT01331694|3079623|Superiority or Other||Hazard Ratio (HR)|1.49||||||95.0|1.26|1.76|||||Hazard ratio for outpatient visit with oral steroid fill for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization||
1674311|NCT01331694|3079623|Superiority or Other||Hazard Ratio (HR)|1.65||||||95.0|1.41|1.94|||||Hazard ratio for outpatient visit with oral steroid fill for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization||
1674312|NCT01331694|3079623|Superiority or Other||Hazard Ratio (HR)|1.33||||||95.0|1.17|1.51|||||Hazard ratio for emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization||
1674313|NCT01331694|3079623|Superiority or Other||Hazard Ratio (HR)|1.78||||||95.0|1.59|2.0|||||Hazard ratio for emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization||
1674314|NCT01331694|3079623|Superiority or Other||Hazard Ratio (HR)|1.29||||||95.0|1.17|1.41|||||Hazard ratio for hospitalization or emergency department visit for TIO compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization||
1674315|NCT01331694|3079623|Superiority or Other||Hazard Ratio (HR)|1.64||||||95.0|1.5|1.79|||||Hazard ratio for hospitalization or emergency department visit for IP compared to FSC; HR estimate adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization||
1674316|NCT01331681|3079624|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.8498|2-Sided|97.5|-4.79|4.05|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups|
1674317|NCT01331681|3079624|Superiority or Other||Mean Difference (Final Values)|-1.19||||0.5138|2-Sided|97.5|-5.29|2.91|||ANCOVA||LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups|
1674318|NCT01331681|3079625|Superiority or Other||Mean Difference (Final Values)|-1.21||||0.5537|2-Sided|97.5|-5.79|3.37||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value is not below of 0.025, the fixed sequence testing stops here. The sixth secondary endpoint cannot be tested confirmatory.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups|
1674319|NCT01331681|3079625|Superiority or Other||Mean Difference (Final Values)|2.41||||0.2208|2-Sided|97.5|-2.01|6.82||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value is not below of 0.025, the fixed sequence testing stops here. The sixth secondary endpoint cannot be tested confirmatory.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups|
1674320|NCT01331681|3079626|Superiority or Other||Mean Difference (Final Values)|-142.8|||<|0.0001|2-Sided|97.5|-179.3|-106.3||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fifth secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A negative value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups|
1674321|NCT01331681|3079626|Superiority or Other||Mean Difference (Final Values)|-157.0|||<|0.0001|2-Sided|97.5|-190.9|-123.1||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fifth secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups|
1674322|NCT01331681|3079627|Superiority or Other||CMH adjusted difference|19.3||||0.0006|2-Sided|97.5|6.6|32.1||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fourth secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to improve by >= 2 steps identical in both groups|
1674323|NCT01331681|3079627|Superiority or Other||CMH adjusted difference|25.8|||<|0.0001|2-Sided|97.5|12.2|39.4||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the fourth secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to improve by >= 2 steps identical in both groups|
1674324|NCT01331681|3079628|Superiority or Other||CMH adjusted difference|24.2|||<|0.0001|2-Sided|97.5|13.5|34.9||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the third secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain >= 15 letters identical in both groups|
1674348|NCT01330303|3079745|Non-Inferiority or Equivalence|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency – National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|101.91||||||90.0|95.0|109.33|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.||
1674325|NCT01331681|3079628|Superiority or Other||CMH adjusted difference|23.3|||<|0.0001|2-Sided|97.5|12.6|33.9||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the third secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain >= 15 letters identical in both groups|
1674326|NCT01331681|3079629|Superiority or Other||CMH adjusted difference|27.5|||<|0.0001|2-Sided|97.5|14.6|40.5||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the second secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain >= 10 letters identical in both groups|
1674327|NCT01331681|3079629|Superiority or Other||CMH adjusted difference|28.7|||<|0.0001|2-Sided|97.5|15.8|41.6||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value and the preceding ones were below the significance level of 0.025, the fixed sequence testing did continue with the second secondary endpoint.|Cochran-Mantel-Haenszel|Stratifying by geographic region (Japan vs non-Japan).|The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Probability to gain >= 10 letters identical in both groups|
1674328|NCT01331681|3079630|Superiority or Other||Mean Difference (Final Values)|9.1|||<|0.0001|2-Sided|97.5|6.3|11.8||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value was below the significance level of 0.025, the fixed sequence testing did continue with the first secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|LS mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups|
1674329|NCT01331681|3079630|Superiority or Other||Mean Difference (Final Values)|9.3|||<|0.0001|2-Sided|97.5|6.5|12.0||Significance level alpha=0.025 for two sided test to adjust for multiplicity. Since this p-value was below the significance level of 0.025, the fixed sequence testing did continue with the first secondary endpoint.|ANCOVA|Treatment group and geographic region (Japan vs. Non-Japan) as factors and baseline value as covariate.|Least square (LS) mean difference from ANCOVA. The estimate is calculated as EYLEA minus Laser. A positive value indicates a result in favor of EYLEA.|Hypothesis: Mean change identical in both groups|
1674330|NCT01331304|3079634|Superiority|||||||0.7||||||Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05|Mixed Models Analysis|||Mixed-effects linear regression analyses compared the two intervention groups on the repeated assessment of the LIFE-RIFT over 6 months|
1674331|NCT01331304|3079635|Superiority|||||||0.11||||||Analysis of this secondary outcome was not corrected for multiple comparisons. Therefore, the a priori threshold for statistical significance was set at 0.05|Mixed Models Analysis|||Mixed-effects linear regression analyses compared the two intervention groups on the repeated collection of measures relevant to calculation of the Framingham Risk Score over 6 months|
1674332|NCT01331304|3079636|Superiority or Other|||||||0.118|||||||Wilcoxon (Mann-Whitney)|||For the second co-primary, patient monthly rates of NCAs (determined by dividing total number of NCAs during follow-up by the length of follow-up – to account for attrition and resulting differential exposure time) for treatment groups were compared using a Wilcoxon rank-sum test.|
1674333|NCT01331304|3079637|Superiority or Other|||||||0.59||||||Because this study has co-primary outcomes (CGI-EI and NCAs), the analyses of the treatment effect in the two primary hypotheses each involved a two-tailed alpha-level of 0.025.|Mixed Models Analysis|||For the first co-primary aim, mixed-effects linear regression analyses compared the two intervention groups on the repeated assessments of the CGI-EI over 6 months.|
1674334|NCT01330420|3079695|Superiority or Other||||||<|0.01|||||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention|
1674335|NCT01330420|3079697|Superiority or Other||||||<|0.01|||||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention|
1674336|NCT01330420|3079698|Superiority or Other||||||<|0.001|||||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention|
1674337|NCT01330420|3079699|Superiority or Other||||||<|0.001|||||||Wilcoxon signed-ranked test|||Due to the small sample size, the Wilcoxon signed-ranked test, a non-parametric statistical test, was used to detect outcome measure changes from pre-intervention to post-intervention|
1674338|NCT01330381|3079705|Superiority or Other|||||||0.3044|||||||Van Elteren test||||
1674339|NCT01330381|3079706|Superiority or Other||||||<|0.0001|||||||Van Elteren test||||
1674340|NCT01330381|3079707|Superiority or Other|||||||0.4647|||||||Van Elteren test||||
1674341|NCT01330381|3079708|Superiority or Other|||||||0.0003|||||||Van Elteren test||||
1674342|NCT01330381|3079709|Superiority or Other|||||||0.1599|||||||Van Elteren test||||
1674343|NCT01330381|3079712|Superiority or Other|||||||0.377|||||||Chi-squared||||
1674344|NCT01330381|3079721|Superiority or Other|||||||0.5228|||||||Cochran-Mantel-Haenszel||||
1674345|NCT01330381|3079722|Superiority or Other|||||||0.352|||||||Cochran-Mantel-Haenszel||||
1674346|NCT01330381|3079723|Superiority or Other|||||||0.9002|||||||Cochran-Mantel-Haenszel||||
1674347|NCT01330303|3079744|Non-Inferiority or Equivalence|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency – National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|94.04||||||90.0|86.33|102.44|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.||
1674349|NCT01330303|3079746|Non-Inferiority or Equivalence|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency – National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|101.89||||||90.0|94.91|109.39|||||The ratios between the geometric means of the test (T) and reference (R) formulations were calculated.||
1674350|NCT01330017|3079783|Superiority or Other|||||||0.5983||||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA||||
1674351|NCT01330017|3079783|Superiority or Other|||||||0.2186||||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA||||
1674352|NCT01330017|3079783|Superiority or Other|||||||0.4519||||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA||||
1674353|NCT01330017|3079783|Superiority or Other|||||||0.4912||||||The p-value reflects mean change from baseline vs. placebo from an ANCOVA model with adjustments for baseline reflective score value, investigative site, age, and gender.|ANCOVA||||
1674354|NCT01329978|3079800|Superiority or Other||Difference in proportions|-0.4||||0.93|2-Sided|95.0|-10.8|9.9||The p-value is based on the CMH test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel|The difference in proportions and its 95% CI were calculated based on stratum-adjusted MH proportions.||The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (< 800,000 IU/mL versus ≥ 800,000 IU/mL).|
1674355|NCT01329978|3079800|Superiority or Other||Difference in proportions|-1.4||||0.77|2-Sided|95.0|-12.2|9.4||The p-value is based on the Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factors.|Cochran-Mantel-Haenszel||The difference in proportions and its 95% confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel (MH) proportions.|The analyses was stratified by IL28B (CC versus any T allele) and plasma HCV RNA (< 800,000 IU/mL versus ≥ 800,000 IU/mL). Only participants with genotype 1 were included in the comparison due to the fact that participants with genotype 4 and 6 were only enrolled in the SOF+PEG+RBV 24 weeks group.|
1674356|NCT01329380|3079852|Other|||||||1|||||||Fisher Exact|||BASDAI at start of treatment|
1674357|NCT01329380|3079852|Other|||||||0.8836|||||||Fisher Exact|||Human leukocyte antigen B27 (HLA-B27) test result|
1674358|NCT01329380|3079852|Other|||||||1|||||||Fisher Exact|||Concomitant therapy|
1674359|NCT01329380|3079852|Other|||||||0.0094|||||||Fisher Exact|||Concomitant drugs - Adrenal corticosteroids|
1674360|NCT01329380|3079852|Other|||||||1|||||||Fisher Exact|||Concomitant drugs - salazosulfapyridine|
1674361|NCT01329380|3079852|Other|||||||0.1558|||||||Fisher Exact|||Concomitant drugs - Methotrexate|
1674362|NCT01329380|3079852|Other|||||||0.2481|||||||Fisher Exact|||Concomitant drugs - DMARDs|
1674363|NCT01329380|3079852|Other|||||||1|||||||Fisher Exact|||Concomitant drug: NSAIDs|
1674364|NCT01329380|3079852|Other|||||||0.0226|||||||Fisher Exact|||Concomitant drugs|
1674365|NCT01329380|3079852|Other|||||||0.254|||||||Fisher Exact|||Prior medications - Adrenal corticosteroids|
1674366|NCT01329380|3079852|Other|||||||0.8875|||||||Fisher Exact|||Prior medications - Biological products|
1674367|NCT01329380|3079852|Other|||||||0.2735|||||||Fisher Exact|||Prior medications - NSAIDs|
1674368|NCT01329380|3079852|Other|||||||0.3928|||||||Fisher Exact|||Adalimumab self-injection status|
1674369|NCT01329380|3079852|Other|||||||1|||||||Fisher Exact|||Allergy history|
1674370|NCT01329380|3079852|Other|||||||0.0144|||||||Fisher Exact|||Past Illnesses|
1674371|NCT01329380|3079852|Other|||||||1|||||||Fisher Exact|||Complications - Psoriasis|
1674372|NCT01329380|3079852|Other|||||||1|||||||Fisher Exact|||Complications - Inflammatory bowel disease|
1674373|NCT01329380|3079852|Other|||||||0.5723|||||||Fisher Exact|||Complications - Uveitis|
1674374|NCT01329380|3079852|Other|||||||0.8193|||||||Fisher Exact|||Complications - Diabetes mellitus|
1674375|NCT01329380|3079852|Other|||||||0.6355|||||||Fisher Exact|||Complications - Respiratory disorder|
1674376|NCT01329380|3079852|Other|||||||0.482|||||||Fisher Exact|||Complications - Blood disorder|
1674377|NCT01329380|3079852|Other|||||||0.8749|||||||Fisher Exact|||Complications - Cardiovascular disorder|
1674378|NCT01329380|3079852|Other|||||||0.2067|||||||Fisher Exact|||Complications - Renal disorder|
1674379|NCT01329380|3079852|Other|||||||0.663|||||||Fisher Exact|||Complications - Liver disorder|
1674380|NCT01329380|3079852|Other|||||||0.4855|||||||Fisher Exact|||Complications|
1674381|NCT01329380|3079852|Other|||||||0.0388|||||||Fisher Exact|||Smoking history|
1674382|NCT01329380|3079852|Other|||||||0.8872|||||||Mann-Whitney U-test|||Duration of illness|
1674383|NCT01329380|3079852|Other|||||||0.0465|||||||Mann-Whitney U-test|||Body mass index|
1674384|NCT01329380|3079852|Other|||||||0.7128|||||||Fisher Exact|||Sex|
1674385|NCT01329380|3079852|Other|||||||0.0328|||||||Mann-Whitney U-test|||Age|
1674386|NCT01329198|3079859|Superiority||Mean Difference (Final Values)|-17.8|Standard Deviation|9.4||0.013|2-Sided||||||ANOVA||Mean change in YGTSS scores from Baseline to 6 Months across all study participants presented.||
1674387|NCT01329029|3079865|Superiority or Other||Hazard Ratio (HR)|0.977|Standard Error of the Mean|0.0865||0.7943|2-Sided|95.0|0.821|1.162||Level of significance: 5% 2-sided.|Cox-proportional hazards model||||
1674388|NCT01329029|3079867|Superiority or Other||Hazard Ratio (HR)|1.083|Standard Error of the Mean|0.3832||0.8208|2-Sided|95.0|0.542|2.167||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of < 1 represents a lower hazard for the test treatment.||
1674389|NCT01329029|3079869|Superiority or Other||Hazard Ratio (HR)|0.695|Standard Error of the Mean|0.2691||0.3477|2-Sided|95.0|0.326|1.484||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of < 1 represents a lower hazard for the test treatment.||
1674415|NCT01328951|3079898|Superiority or Other||Odds Ratio (OR)|1.09|||||2-Sided|95.0|0.79|1.49|||||The 95% CI for OR was constructed using the Wald method.||
1674390|NCT01329029|3079870|Superiority or Other||Hazard Ratio (HR)|1.529|Standard Error of the Mean|0.1463|<|0.0001|2-Sided|95.0|1.268|1.845|||Cox-proportional hazards model|Level of significance: 5% 2-sided.|A hazards ratio of < 1 represents a lower hazard for the test treatment.||
1674391|NCT01329029|3079871|Superiority or Other||Hazard Ratio (HR)|1.078|Standard Error of the Mean|0.5765||0.8876|2-Sided|95.0|0.378|3.075|||Cox-proportional hazards model|Level of significance: 5% 2-sided.|A hazards ratio of < 1 represents a lower hazard for the test treatment.||
1674392|NCT01329029|3079872|Superiority or Other||Hazard Ratio (HR)|1.025|Standard Error of the Mean|0.3468||0.9414|2-Sided|95.0|0.528|1.99||Level of significance: 5% 2-sided.|Cox-proportional hazards model||A hazards ratio of < 1 represents a lower hazard for the test treatment.||
1674393|NCT01329029|3079874|Superiority or Other||Least Square Mean Difference|-0.285|Standard Error of the Mean|0.2175||0.1909|2-Sided|95.0|-0.711|0.142||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.|||
1674394|NCT01329029|3079877|Superiority or Other||Least Square Mean Difference|-0.015|Standard Error of the Mean|0.0439||0.7392|2-Sided|95.0|-0.101|0.071||Level of significance: 5% 2-sided.|Repeated measurement model|Compound symmetry covariance structure and REML.|||
1674395|NCT01329029|3079878|Superiority or Other||Least Square Mean Difference|-0.283|Standard Error of the Mean|0.0941||0.0027|2-Sided|95.0|-0.467|-0.098||Level of significance: 5% 2-sided.|Repeated measurement model|Compound symmetry covariance structure and REML.|||
1674396|NCT01329029|3079880|Superiority or Other||Least Square Mean Difference|0.094|Standard Error of the Mean|0.0131|<|0.0001|2-Sided|95.0|0.069|0.12||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.|||
1674397|NCT01329029|3079881|Superiority or Other||Least Square Mean Difference|0.025|Standard Error of the Mean|0.0062|<|0.0001|2-Sided|95.0|0.013|0.038||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and REML.|||
1674398|NCT01329029|3079882|Superiority or Other||Least Square Mean Difference|0.092|Standard Error of the Mean|0.0159|<|0.0001|2-Sided|95.0|0.061|0.124||Level of significance: 5% 2-sided.|Repeated measurement model|Unstructured covariance structure and restricted maximum likelihood (REML).|||
1674399|NCT01329029|3079885|Superiority or Other||NNTB|9.0|||||2-Sided|95.0|4.0|31.0|||||||
1674400|NCT01329029|3079886|Superiority or Other||Hazard Ratio (HR)|0.749|Standard Error of the Mean|0.1209||0.0731|2-Sided|95.0|0.546|1.027||Level of significance: 5% 2-sided|Wei-Lin-Weissfeld Method||A hazard ratio of <1 represents a favourable outcome for the test treatment.||
1674401|NCT01329029|3079887|Superiority or Other||Hazard Ratio (HR)|0.79|Standard Error of the Mean|0.0842||0.027|2-Sided|95.0|0.641|0.974||Level of significance: 5% 2-sided|Wei-Lin-Weissfeld Method||A hazard ratio of <1 represents a favourable outcome for the test treatment||
1674402|NCT01329029|3079888|Superiority or Other||Hazard Ratio (HR)|0.917|Standard Error of the Mean|0.0549||0.1461|2-Sided|95.0|0.815|1.031||Level of significance: 5% 2-sided.|Cox proportional hazards model||A hazards ratio of < 1 represents a lower hazard for the test treatment.||
1674403|NCT01329029|3079890|Superiority or Other||Rate ratio|0.761|Standard Error of the Mean|0.0899||0.0209|2-Sided|95.0|0.604|0.96||Level of significance: 5% 2-sided.|Generalized Linear Regression|Negative binomial regression model (estimates of exacerbation rates)|A rate ratio of < 1 represents a favourable outcome for the test treatment.|Leading to Hospitalisation|
1674404|NCT01329029|3079890|Superiority or Other||Rate ratio|0.837|Standard Error of the Mean|0.0528||0.0047|2-Sided|95.0|0.739|0.947||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of < 1 represents a favourable outcome for the test treatment.|Moderate or Severe COPD Exacerbations and/or treated with Antibiotics|
1674405|NCT01329029|3079890|Superiority or Other||Rate ratio|0.854|Standard Error of the Mean|0.0605||0.0262|2-Sided|95.0|0.744|0.982||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of < 1 represents a favourable outcome for the test treatment.|COPD Exacerbations treated with Glucocorticosteroids and/or Antibiotics|
1674406|NCT01329029|3079890|Superiority or Other||Rate Ratio|0.794|Standard Error of the Mean|0.0654||0.005|2-Sided|95.0|0.675|0.933||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of < 1 represents a favourable outcome for the test treatment.|Mild, Moderate or Severe COPD Exacerbations|
1674407|NCT01329029|3079890|Superiority or Other||Rate ratio|0.914|Standard Error of the Mean|0.0771||0.2875|2-Sided|95.0|0.775|1.078||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of < 1 represents a favourable outcome for the test treatment.|Moderate COPD Exacerbations|
1674408|NCT01329029|3079891|Superiority or Other||Rate ratio|0.757|Standard Error of the Mean|0.0889||0.0175|2-Sided|95.0|0.601|0.952|||Generalized Linear Regression|Analyzed using a negative binomial regression model excluding a correction for overdispersion.|A rate ratio of < 1 represents a favourable outcome for the test treatment.||
1674409|NCT01329029|3079892|Superiority or Other||LS Mean difference|0.056|Standard Error of the Mean|0.0089|<|0.0001|2-Sided|95.0|0.038|0.073|||ANCOVA|Analysis of Covariance (ANCOVA) including treatment by time interaction.|||
1674410|NCT01329029|3079893|Superiority or Other||Rate ratio|0.868|Standard Error of the Mean|0.0633||0.0529|2-Sided|95.0|0.753|1.002||Level of significance: 5% 2-sided|Generalized Linear Regression|Poisson regression model (estimates of exacerbation rates using time in trial as model offset).|A rate ratio of < 1 represents a favourable outcome for the test treatment.||
1674411|NCT01328964|3079894|Superiority or Other||Mean Difference (Net)|-28.0|||<|0.0001|2-Sided|95.0|-28.0|-27.0||P-value is based on difference in total monthly asthma costs|Regression, Linear||||
1674412|NCT01328964|3079895|Superiority or Other||Hazard Ratio (HR)|0.751||||0.0495|2-Sided|95.0|0.565|0.999||P-value is based on the comparison of combined endpoint of hospitalization/emergency department visits|Regression, Cox||||
1674413|NCT01328964|3079896|Superiority or Other||Mean Difference (Net)|-14.0|||<|0.001|2-Sided|95.0|-19.0|-9.0||P-value is based on the differences in the total monthly asthma costs|Regression, Linear||||
1674414|NCT01328964|3079897|Superiority or Other||Hazard Ratio (HR)|0.71|||<|0.0001|2-Sided|95.0|0.51|0.974||The p-value is a comparison of the combined hospitalization/emergency department visit endpoint|Regression, Cox||||
1674419|NCT01328951|3079901|Superiority or Other||Difference in Event-Free Rate|-2.89||||0.4069|2-Sided|95.0|-9.7|3.93|||Chi-squared||||
1674420|NCT01328951|3079902|Superiority or Other||Hazard Ratio (HR)|0.87||||0.1635|2-Sided|95.0|0.72|1.06|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Stratified Analysis: Stratified according to tumor histology, stage of disease, objective response at Baseline, bevacizumab use, smoking status, and region of enrollment.|
1674421|NCT01328951|3079902|Superiority or Other||Hazard Ratio (HR)|0.94||||0.4759|2-Sided|95.0|0.8|1.11|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Unstratified Analysis.|
1674422|NCT01328951|3079904|Superiority or Other||Difference in Event-Free Rate|-0.4||||0.9207|2-Sided|95.0|-8.25|7.45|||Chi-squared||||
1674423|NCT01328951|3079905|Superiority or Other||Hazard Ratio (HR)|1.07||||0.5256|2-Sided|95.0|0.87|1.32|||Log Rank||The HR and 95% CI were estimated by Cox regression.|Stratified Analysis: Stratified according to tumor histology, stage of disease, objective response at Baseline, bevacizumab use, smoking status, and region of enrollment.|
1674424|NCT01328951|3079905|Superiority or Other||Hazard Ratio (HR)|1.02||||0.8183|2-Sided|95.0|0.85|1.22|||Log Rank||The HR and 95% confidence interval (CI) were estimated by Cox regression.|Unstratified Analysis.|
1674425|NCT01328782|3079913|Superiority or Other|||||||0.499|||||||Chi-squared||||
1674426|NCT01328782|3079913|Superiority or Other|||||||0.004|||||||Chi-squared||||
1674427|NCT01328782|3079913|Superiority or Other|||||||0.004|||||||Chi-squared||||
1674428|NCT01328782|3079914|Superiority or Other||Mean Difference (Final Values)|0.011||||0.5321||95.0|-0.024|0.045|||ANOVA||||
1674429|NCT01328782|3079914|Superiority or Other||Mean Difference (Final Values)|0.031||||0.078||95.0|-0.004|0.066|||ANOVA||||
1674430|NCT01328782|3079914|Superiority or Other||Mean Difference (Final Values)|0.042||||0.008||95.0|0.008|0.076|||ANOVA||||
1674431|NCT01328782|3079915|Superiority or Other|||||||0.039|||||||Log Rank||||
1674432|NCT01328782|3079915|Superiority or Other|||||||0.3767|||||||Log Rank||||
1674433|NCT01328782|3079915|Superiority or Other|||||||0.005|||||||Log Rank||||
1674434|NCT01328782|3079916|Superiority or Other||Mean Difference (Final Values)|1.66||||0.027||95.0|0.2|3.12|||ANOVA||||
1674435|NCT01328782|3079916|Superiority or Other||Mean Difference (Net)|0.16||||0.832||95.0|-1.3|1.61|||ANOVA||||
1674436|NCT01328782|3079916|Superiority or Other||Mean Difference (Final Values)|1.81||||0.014|2-Sided|95.0|0.38|3.25|||ANOVA||||
1674437|NCT01328782|3079917|Superiority or Other||Mean Difference (Final Values)|0.93||||0.244||95.0|-0.64|2.49|||ANOVA||||
1674438|NCT01328782|3079917|Superiority or Other||Mean Difference (Final Values)|0.556||||0.556||95.0|-1.12|2.08|||ANOVA||||
1674439|NCT01328782|3079917|Superiority or Other||Mean Difference (Net)|1.4||||0.074||95.0|1.4|2.94|||ANOVA||||
1674440|NCT01328756|3079922|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Change from baseline to LOTA value was assessed for differences from zero using a 2-sided, 1 sample t-test at a 0.05 significance level.|
1674441|NCT01328743|3079934|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1674442|NCT01328743|3079935|Superiority|||||||0.25|||||||t-test, 2 sided||||
1674443|NCT01328743|3079936|Superiority|||||||0.48|||||||Wilcoxon (Mann-Whitney)||||
1674444|NCT01328743|3079937|Superiority||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1674445|NCT01328743|3079938|Superiority||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1674446|NCT01328743|3079939|Superiority|||||||0.04|||||||t-test, 2 sided||||
1674447|NCT01328444|3079975|Superiority or Other||Least squares mean difference|0.169|||<|0.001|2-Sided|95.0|0.129|0.209||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.||
1674448|NCT01328444|3079975|Superiority or Other||Least squares mean difference|0.211|||<|0.001|2-Sided|95.0|0.172|0.249||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.||
1674449|NCT01328444|3079975|Superiority or Other||Least squares mean difference|0.07|||<|0.007|2-Sided|95.0|0.019|0.12||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.||
1674450|NCT01328444|3079975|Superiority or Other||Least squares mean difference|0.029|||<|0.32|2-Sided|95.0|-0.028|0.086||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.||
1674451|NCT01328444|3079975|Superiority or Other||Least squares mean difference|0.111|||<|0.001|2-Sided|95.0|0.062|0.161||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.||
1674452|NCT01328444|3079975|Superiority or Other||Least squares mean difference|0.124|||<|0.001|2-Sided|95.0|0.067|0.181||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.||
1674453|NCT01328444|3079975|Superiority or Other||Least squares mean difference|0.099|||<|0.001|2-Sided|95.0|0.05|0.148||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.||
1674454|NCT01328444|3079975|Superiority or Other||Least squares mean difference|0.14|||<|0.001|2-Sided|95.0|0.084|0.196||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.||
1674455|NCT01328444|3079975|Superiority or Other||Least squares mean difference|0.087|||<|0.003|2-Sided|95.0|0.03|0.143||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.||
1674456|NCT01328444|3079976|Superiority or Other||Least squares mean difference|32.4||||0.08|2-Sided|95.0|-3.9|68.8||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.||
1675539|NCT01309360|3082375|Superiority or Other|||||||1|||||||Fisher Exact||||
1674457|NCT01328444|3079976|Superiority or Other||Least squares mean difference|21.9||||0.234|2-Sided|95.0|-14.2|58.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.||
1674458|NCT01328444|3079976|Superiority or Other||Least squares mean difference|42.4||||0.072|2-Sided|95.0|-3.8|88.7||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.||
1674459|NCT01328444|3079976|Superiority or Other||Least squares mean difference|19.3||||0.472|2-Sided|95.0|-33.4|71.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.||
1674460|NCT01328444|3079976|Superiority or Other||Least squares mean difference|31.9||||0.174|2-Sided|95.0|-14.1|77.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.||
1674461|NCT01328444|3079976|Superiority or Other||Least squares mean difference|-4.6||||0.865|2-Sided|95.0|-57.6|48.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.||
1674462|NCT01328444|3079976|Superiority or Other||Least squares mean difference|-10.0||||0.665|2-Sided|95.0|-55.5|35.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.||
1674463|NCT01328444|3079976|Superiority or Other||Least squares mean difference|13.1||||0.62|2-Sided|95.0|-38.9|65.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.||
1674464|NCT01328444|3079976|Superiority or Other||Least squares mean difference|26.5||||0.321|2-Sided|95.0|-25.9|78.9||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.||
1674465|NCT01328379|3079989|Superiority or Other||Least Squares Mean|2.3|Standard Error of the Mean|1.8||0.203|2-Sided|95.0|-1.2|5.8|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in EQ-5D VAS score at Visit 3|
1674466|NCT01328379|3079989|Superiority or Other||Least Squares Mean|-1.2|Standard Error of the Mean|1.83||0.53|2-Sided|95.0|-4.7|2.4|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in EQ-5D VAS score at Visit 3|
1674467|NCT01328379|3079989|Superiority or Other||Least Squares Mean|-3.4|Standard Error of the Mean|1.79||0.055|2-Sided|95.0|-7.0|0.1|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in EQ-5D VAS score at Visit 3|
1674468|NCT01328379|3079990|Superiority or Other||Least Squares Mean|0.0|Standard Error of the Mean|0.03||0.185|2-Sided|95.0|-0.1|0.0|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in Average EQ-5D score at Visit 3|
1674469|NCT01328379|3079990|Superiority or Other||Least Squares Mean|0.0|Standard Error of the Mean|0.03||0.734|2-Sided|95.0|-0.1|0.0|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in Average EQ-5D score at Visit 3|
1674470|NCT01328379|3079990|Superiority or Other||Least Squares Mean|0.0|Standard Error of the Mean|0.03||0.32|2-Sided|95.0|0.0|0.1|||ANOVA|ANOVA model with change from baseline score as the dependant variable and baseline score and treatment as the independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in Average EQ-5D score at Visit 3|
1674471|NCT01328379|3079991|Superiority or Other||Least Squares Mean|51.7|Standard Error of the Mean|34.21||0.133|2-Sided|95.0|-15.9|119.3|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in Six-Minute Walk Distance at visit 2|
1674472|NCT01328379|3079991|Superiority or Other||Least Squares Mean|87.1|Standard Error of the Mean|34.9||0.014|2-Sided|95.0|18.2|156.1|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in Six-Minute Walk Distance at visit 2|
1674473|NCT01328379|3079991|Superiority or Other||Least Squares Mean|35.4|Standard Error of the Mean|34.57||0.308|2-Sided|95.0|-33.0|103.7|||ANOVA|Change from Baseline in Six-Minute Walk Distance as dependent variable and Baseline Six-Minute Walk Distance and Treatment as independent variables.||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in Six-Minute Walk Distance at visit 2|
1674474|NCT01328379|3079992|Superiority or Other||Least Squares Mean|-1.21|Standard Error of the Mean|2.236||0.588|2-Sided|95.0|-5.61|3.18|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in MSWS-12 at visit 2|
1674475|NCT01328379|3079992|Superiority or Other||Least Squares Mean|-0.38|Standard Error of the Mean|2.258||0.868|2-Sided|95.0|-4.81|4.06|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 2|
1674476|NCT01328379|3079992|Superiority or Other||Least Squares Mean|0.84|Standard Error of the Mean|2.237||0.708|2-Sided|95.0|-3.56|5.24|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 2|
1674477|NCT01328379|3079993|Superiority or Other||Least Squares Mean|-2.16|Standard Error of the Mean|2.366||0.362|2-Sided|95.0|-6.81|2.49|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in MSWS-12 at visit 3|
1674478|NCT01328379|3079993|Superiority or Other||Least Squares Mean|-2.56|Standard Error of the Mean|2.393||0.286|2-Sided|95.0|-7.26|2.15|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 3|
1674479|NCT01328379|3079993|Superiority or Other||Lease Squares Mean|-0.4|Standard Error of the Mean|2.367||0.866|2-Sided|95.0|-5.05|4.25|||ANOVA|ANOVA model with change from baseline in MSWS-12 Score as the dependent variable and baseline MSWS-12 Score and treatment as the independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in MSWS-12 at visit 3|
1674480|NCT01328379|3079994|Superiority or Other||Least Squares Mean|0.107|Standard Error of the Mean|0.0666||0.108|2-Sided|95.0|-0.024|0.238|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3|
1674481|NCT01328379|3079994|Superiority or Other||Least Squares Mean|0.093|Standard Error of the Mean|0.0674||0.167|2-Sided|95.0|-0.039|0.226|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3|
1674482|NCT01328379|3079994|Superiority or Other||Least Squares Mean|-0.014|Standard Error of the Mean|0.0666||0.832|2-Sided|95.0|-0.145|0.117||To demonstrate study sensitivity with respect to efficacy and maintain an overall alpha level ≤ 0.05, a stepwise procedure was performed.|ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CminSS at Visit 3|
1674483|NCT01328379|3079995|Superiority or Other||least squares mean|0.064|Standard Error of the Mean|0.0724||0.375|2-Sided|95.0|-0.078|0.207|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. dalfampridine-ER 10mg twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3|
1674484|NCT01328379|3079995|Superiority or Other||least squares mean|0.118|Standard Error of the Mean|0.0732||0.107|2-Sided|95.0|-0.026|0.262|||ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 10mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3|
1674485|NCT01328379|3079995|Superiority or Other||least squares mean|0.054|Standard Error of the Mean|0.0724||0.457|2-Sided|95.0|-0.088|0.196||To demonstrate study sensitivity with respect to efficacy and maintain an overall alpha level ≤ 0.05, a stepwise procedure was performed.|ANOVA|ANOVA Model: Change from Baseline in Walking Speed - dependent variable and Baseline Walking Speed and Treatment - independent variables||dalfampridine-ER 5mg twice daily vs. placebo twice daily: Change from baseline in walking speed at Approximately CmaxSS at Visit 3|
1674486|NCT01328249|3080012|Other|Fisher’s Exact test||||||0.4422||||||Null hypothesis: The feasibility rates of Cohort 1 and Cohort 2 are same.|Fisher Exact|Exploratory analysis comparing primary feasibilities between 2 cohorts, based on Fisher's Exact test.|||
1674487|NCT01328184|3080027|Non-Inferiority or Equivalence|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|105.81|Standard Deviation|10.7|||2-Sided|90.0|99.47|112.55|||||Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.|
1674488|NCT01328184|3080028|Non-Inferiority or Equivalence|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|99.22|Standard Deviation|10.4|||2-Sided|90.0|93.4|105.39|||||Standard deviation is actually the geometric coefficient of variation (gCV).|No formal testing, investigation of relative bioavailability.|
1674489|NCT01328184|3080029|Non-Inferiority or Equivalence|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|101.94|Standard Deviation|5.9|||2-Sided|90.0|98.54|105.47|||||Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.|
1674490|NCT01328184|3080030|Non-Inferiority or Equivalence|Ratio calculated as Microgynon plus empa divided by Microgynon|Geometric Mean Ratio|102.82|Standard Deviation|9.0|||2-Sided|90.0|97.58|108.35|||||Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability.|
1674491|NCT01328054|3080080|Superiority or Other||Mean Difference (Final Values)|3.75|Standard Error of the Mean|2.164|||2-Sided|90.0|0.15|7.36|||||CI, estimated value and dispersion value of is presented for 24 hour post dose||
1674492|NCT01328054|3080080|Superiority or Other||Mean Difference (Final Values)|5.76|Standard Error of the Mean|2.759|||2-Sided|90.0|1.16|10.36|||||CI, estimated value and dispersion value of is presented for 12 hour post dose||
1674493|NCT01328054|3080080|Superiority or Other||Mean Difference (Final Values)|8.75|Standard Error of the Mean|2.8|||2-Sided|90.0|4.08|13.42|||||CI, estimated value and dispersion value of is presented for 10 hour post dose||
1674494|NCT01328054|3080080|Superiority or Other||Mean Difference (Final Values)|4.91|Standard Error of the Mean|2.735|||2-Sided|90.0|0.35|9.47|||||CI, estimated value and dispersion value of is presented for 8 hour post dose||
1674495|NCT01328054|3080080|Superiority or Other||Mean Difference (Final Values)|5.86|Standard Error of the Mean|2.573|||2-Sided|90.0|1.57|10.14|||||CI, estimated value and dispersion value of is presented for 6 hour post dose||
1674496|NCT01328054|3080080|Superiority or Other||Mean Difference (Final Values)|6.6|Standard Error of the Mean|2.434|||2-Sided|90.0|2.54|10.65|||||CI, estimated value and dispersion value of is presented for 4 hour post dose||
1674497|NCT01328054|3080080|Superiority or Other||Mean Difference (Final Values)|6.42|Standard Error of the Mean|2.085|||2-Sided|90.0|2.94|9.89|||||CI, estimated value and dispersion value of is presented for 3 hour post dose||
1674498|NCT01328054|3080080|Superiority or Other||Mean Difference (Final Values)|7.71|Standard Error of the Mean|1.734|||2-Sided|90.0|4.82|10.6|||||CI, estimated value and dispersion value of is presented for 2 hour post dose||
1674499|NCT01328054|3080080|Superiority or Other||Mean Difference (Final Values)|6.43|Standard Error of the Mean|2.059|||2-Sided|90.0|3.0|9.87|||||CI, estimated value and dispersion value of is presented for 1 hour post dose||
1674500|NCT01328054|3080080|Superiority or Other||Mean Difference (Final Values)|6.31|Standard Error of the Mean|2.151|||2-Sided|90.0|2.72|9.89|||||Confidence interval (CI), estimated value and dispersion value of is presented for pre dose||
1674501|NCT01328041|3080097|Superiority or Other||percentage of participants|63.0|||||2-Sided|95.0|56.0|70.0|||||The estimated value represents the percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 48.||
1674502|NCT01328041|3080098|Superiority or Other||percentage of participants|69.0|||||2-Sided|95.0|62.0|76.0|||||The estimated value represents the percentage of participants with HIV-1 RNA less than 50 copies/mL at Week 24.||
1674503|NCT01328041|3080099|Superiority or Other||T distribution|-1.432|||<|0.001|2-Sided|95.0|-1.52|-1.343||The P value was derived by the null hypothesis testing of no change from Baseline in HIV-1 RNA at Day 8 at the two-sided 5% significance level using a single sample t-test.|t-test, 2 sided||||
1674504|NCT01327885|3080114|Superiority or Other||Odds Ratio (OR)|0.9|||=|0|2-Sided|95.0|0.7|1.4||The P-value was calculated using the CMH method. The stratified factors were histology, geographic region, and number of prior regimens for advanced STS.|Cochran-Mantel-Haenszel||The Odds Ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of Odds Ratio is based on asymptotic normal approximation.|The PFR12wks was compared between the treatment arms using stratified CMH chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.|
1674505|NCT01327885|3080115|Superiority or Other||Odds Ratio (OR)|1.3||||0.253|2-Sided|95.0|0.8|1.9||The P-value was calculated using the stratified CMH method, the stratified factors included histology, geographic region, and number of prior regimens for advanced STS.|Cochran-Mantel-Haenszel||The Odds Ratio between eribulin and dacarbazine was calculated by stratified CMH method. The stratified factors were as described above. The 2-sided 95% CI of the Odds Ratio is based on asymptotic normal approximation.|The PFR12wks was compared between the treatment arms using stratified Cochran-Mantal-Haenszel (CMH) chi-square test stratified by histology, geographic region, and number of prior regimens for advanced STS.|
1674506|NCT01327885|3080116|Superiority or Other||Hazard Ratio (HR)|0.877|||=|0|2-Sided|95.0|0.71|1.085||P-value was calculated by 2-sided log-rank test, as stratified by histology, geographic region, and number of prior regimens for advanced STS.|Log Rank||The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.|The PFS and PFS rate at 3, 6, and 12 months (95% confidence interval (CI)) was calculated using Kaplan-Meier (K-M) product-limit method and Greenwood Formula. PFS was compared between the treatment arms using two-sided stratified log-rank test, stratified by histology, geographic region, and number of prior regimens for advanced STS.|
1674507|NCT01327885|3080117|Superiority or Other||Hazard Ratio (HR)|0.768|||=|0|2-Sided|95.0|0.618|0.954||The P-value was calculated by 2-sided log-rank test as stratified by histology, geographic region, and number of prior regimens for advanced STS.|Log Rank||The Hazard Ratio is based on a stratified Cox regression model including treatment as covariate, and histology, geographic region, and number of prior regimens for advanced STS as strata.|Statistical analysis was designed to detect superiority of Arm A (eribulin) over Arm B (dacarbazine). OS was compared between the two treatment arms using a two-sided stratified log-rank test at a nominal significance level of 0.0455 (adjusted for the interim analysis). This was the primary analysis that was performed when the target number of events (~353 deaths) was observed.|
1674508|NCT01327846|3080128|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.96||||0.597|2-Sided|95.0|0.81|1.13||2-sided unadjusted p-value|Regression, Cox||All-cause mortality||
1674509|NCT01327846|3080128|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.92||||0.329|2-Sided|95.0|0.78|1.09||2-sided unadjusted p-value|Regression, Cox||All-cause mortality||
1674510|NCT01327846|3080128|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.93||||0.406|2-Sided|95.0|0.79|1.1||2-sided unadjusted p-value|Regression, Cox||All-cause mortality||
1674511|NCT01327846|3080129|Superiority||Hazard Ratio (HR)|0.94||||0.377|2-Sided|95.0|0.83|1.07||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke||
1674512|NCT01327846|3080129|Superiority||Hazard Ratio (HR)|0.85||||0.011|2-Sided|95.0|0.75|0.96||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke||
1674513|NCT01327846|3080129|Superiority||Hazard Ratio (HR)|0.87||||0.028|2-Sided|95.0|0.77|0.99||2-sided unadjusted p-value|Regression, Cox||All-cause mortality or MI or Stroke||
1674514|NCT01327846|3080130|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.98||||0.6541|2-Sided|95.0|0.8|1.2||1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]|Log Rank||||
1674515|NCT01327846|3080130|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|1.06||||0.8456|2-Sided|95.0|0.87|1.29||1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]|Log Rank||||
1674516|NCT01327846|3080130|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|1.01||||0.8456|2-Sided|95.0|0.83|1.23||1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]|Log Rank||||
1674517|NCT01327846|3080131|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.71||||0.086|2-Sided|95.0|0.48|1.05||2-sided unadjusted p-value|Regression, Cox||unstable angina||
1674518|NCT01327846|3080131|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.64||||0.022|2-Sided|95.0|0.44|0.94||2-sided unadjusted p-value|Regression, Cox||unstable angina||
1674519|NCT01327846|3080131|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.58||||0.007|2-Sided|95.0|0.39|0.86||2-sided unadjusted p-value|Regression, Cox||unstable angina||
1674520|NCT01327846|3080131|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.9||||0.1895|2-Sided|95.0|0.79|1.03||1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]|Log Rank||MACE or unstable angina||
1674883|NCT01320722|3080836|Superiority|||||||0.57||||||Statistical significance was set for P>0.05.|t-test, 2 sided|||Week 8|
1674521|NCT01327846|3080131|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.83||||0.0241|2-Sided|95.0|0.73|0.95||1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]|Log Rank||MACE or unstable angina||
1674522|NCT01327846|3080131|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.82||||0.0648|2-Sided|95.0|0.72|0.94||1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]|Log Rank||MACE or unstable angina||
1674523|NCT01327846|3080134|Other|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|1.04|||||2-Sided|95.0|0.75|1.45|||||Stroke (nonfatal)||
1674524|NCT01327846|3080134|Other|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.99|||||2-Sided|95.0|0.72|1.37|||||Stroke (nonfatal)||
1674525|NCT01327846|3080134|Other|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.57|1.13|||||Stroke (nonfatal)||
1674526|NCT01327846|3080134|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|1.03||||0.871|2-Sided|95.0|0.74|1.43||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)||
1674527|NCT01327846|3080134|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.98||||0.912|2-Sided|95.0|0.71|1.35||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)||
1674528|NCT01327846|3080134|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.8||||0.19|2-Sided|95.0|0.56|1.12||2-sided unadjusted p-value|Regression, Cox||Stroke (fatal and non-fatal)||
1674529|NCT01327846|3080134|Other|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.94|||||2-Sided|95.0|0.78|1.14|||||MI (non-fatal)||
1674530|NCT01327846|3080134|Other|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.76|||||2-Sided|95.0|0.62|0.92|||||MI (non-fatal)||
1674531|NCT01327846|3080134|Other|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.83|||||2-Sided|95.0|0.68|1.0|||||MI (non-fatal)||
1674532|NCT01327846|3080134|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.94||||0.542|2-Sided|95.0|0.78|1.14||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)||
1674533|NCT01327846|3080134|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.76||||0.006|2-Sided|95.0|0.63|0.92||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)||
1674534|NCT01327846|3080134|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.84||||0.067|2-Sided|95.0|0.69|1.01||2-sided unadjusted p-value|Regression, Cox||MI (fatal and non-fatal)||
1674535|NCT01327846|3080134|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.91||||0.369|2-Sided|95.0|0.73|1.12||2-sided unadjusted p-value|Regression, Cox||CV death||
1674536|NCT01327846|3080134|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.9||||0.296|2-Sided|95.0|0.73|1.1||2-sided unadjusted p-value|Regression, Cox||CV death||
1674537|NCT01327846|3080134|Superiority|A HR < 1 favors Canakinumab|Hazard Ratio (HR)|0.94||||0.572|2-Sided|95.0|0.77|1.16||2-sided unadjusted p-value|Regression, Cox||CV death||
1674538|NCT01327846|3080134|Superiority|A HR < 1 favors Canakinumab|Cox Proportional Hazard|0.93||||0.1895|2-Sided|95.0|0.8|1.07||1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]|Log Rank||MACE|H31: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 50 mg dose group is greater than or equal to the hazard rate of the placebo group.|
1674539|NCT01327846|3080134|Superiority|A HR < 1 favors Canakinumab|Cox Proportional Hazard|0.85||||0.0241|2-Sided|95.0|0.74|0.98||1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]|Log Rank||MACE|H21: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 150 mg dose group is greater than or equal to the hazard rate of the placebo group|
1674540|NCT01327846|3080134|Superiority|A HR < 1 favors Canakinumab|Cox Proportional Hazard|0.86||||0.0648|2-Sided|95.0|0.75|0.99||1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]|Log Rank||MACE|H11: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 300 mg dose group is greater than or equal to the hazard rate of the placebo group|
1674541|NCT01327703|3080148|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval (CI) of Panzytrat® versus Kreon® exceeded -10%.|Treatment difference|-2.08||||0.459|2-Sided|95.0|-7.23|4.02||As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Mixed Models Analysis|||Mixed model analysis method was used for comparison using log-transformed percent CFA as the response variable, fixed effect factors for treatment, period, treatment sequence and pooled site and participant within treatment sequence as a random effect.|
1674542|NCT01327573|3080171|Superiority or Other|||||||0.09||||||"This p-value was for the overall slope difference between groups (i.e. the interaction between group and time).~Significance level was set at 0.1 a priori."|Mixed effects model analysis|||Analysis used eGFR, group, time, and group-by-time variables.|
1674543|NCT01327547|3080178|Superiority or Other||Difference in LS Mean|-1.48||||0.1366|2-Sided|95.0|-3.45|0.49|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674544|NCT01327547|3080178|Superiority or Other||Difference in LS Mean|-1.44||||0.2679|2-Sided|95.0|-4.01|1.14|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674545|NCT01327547|3080178|Superiority or Other||Difference in LS Mean|-1.84||||0.1417|2-Sided|95.0|-4.31|0.63|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674546|NCT01327547|3080179|Superiority or Other||Difference in LS Mean|-0.03||||0.8087|2-Sided|95.0|-0.25|0.2|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674547|NCT01327547|3080179|Superiority or Other||Difference in LS Mean|-0.08||||0.4657|2-Sided|95.0|-0.28|0.13|||ANCOVA|||Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674548|NCT01327547|3080179|Superiority or Other||Difference in LS Mean|0.07||||0.5201|2-Sided|95.0|-0.15|0.3|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674549|NCT01327547|3080180|Superiority or Other||Difference in LS mean|-0.02||||0.7275|2-Sided|95.0|-0.16|0.11|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 144 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674550|NCT01327547|3080180|Superiority or Other||Difference in LS mean|0.0||||0.9991|2-Sided|95.0|-0.1|0.1|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 96 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674551|NCT01327547|3080180|Superiority or Other||Difference in LS Mean|0.15||||0.7778|2-Sided|95.0|-0.93|1.23|||ANCOVA||Difference in LS Mean|Results are from an ANCOVA model with change from baseline at Week 48 as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674552|NCT01327547|3080181|Superiority or Other||Difference in LS mean|0.15||||0.2855|2-Sided|95.0|-0.12|0.41|||ANCOVA||Difference in LS mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 144 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674553|NCT01327547|3080181|Superiority or Other||Difference in LS Mean|0.15||||0.266|2-Sided|95.0|-0.12|0.43|||ANCOVA||Difference in LS Mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 96 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674554|NCT01327547|3080181|Superiority or Other||Difference in LS Mean|0.03||||0.8024|2-Sided|95.0|-0.22|0.28|||ANCOVA||Difference in LS Mean|The above analysis is change for baseline in Log10 plasma HCV RNA at 48 Weeks. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674555|NCT01327547|3080182|Superiority or Other||Difference in LS Mean|-173.57||||0.8559|2-Sided|95.0|-2060.81|1713.68|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674556|NCT01327547|3080182|Superiority or Other||Difference in LS Mean|348.7||||0.4388|2-Sided|95.0|-539.61|1237.01|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674557|NCT01327547|3080182|Superiority or Other||Difference in LS Mean|498.04||||0.3786|2-Sided|95.0|-617.33|1613.41|||ANCOVA||Difference in LS Mean|The above analysis is for TGF-beta cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674558|NCT01327547|3080183|Superiority or Other||Difference in LS Mean|-24.49||||0.5816|2-Sided|95.0|-112.21|63.23|||ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674559|NCT01327547|3080183|Superiority or Other||Difference in LS Mean|10.87||||0.7697|2-Sided|95.0|-62.44|84.18|||ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674560|NCT01327547|3080183|Superiority or Other||Difference in LS Mean|0.3||||0.9904|2-Sided|95.0|-48.66|49.26||Not specifed.|ANCOVA||Difference in LS Mean|The above analysis is for D-Dimer cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674561|NCT01327547|3080184|Superiority or Other||Difference in LS Mean|0.92||||0.4196|2-Sided|95.0|-1.33|3.17|||ANCOVA|||The above analysis is for C-reactive protein cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674562|NCT01327547|3080184|Superiority or Other||Difference in LS Mean|0.67||||0.3012|2-Sided|95.0|-0.61|1.96|||ANCOVA|||The above analysis is for C-reactive protein cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674563|NCT01327547|3080184|Superiority or Other||Difference in LS Mean|-2.53||||0.4476|2-Sided|95.0|-9.11|4.05|||ANCOVA||Difference in LS Mean|The above analysis is for C-reactive protein cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674564|NCT01327547|3080185|Superiority or Other||Difference in LS Mean|-29.75||||0.3595|2-Sided|95.0|-93.74|34.24|||ANCOVA|||The above analysis is for CD38 expression on CD4 and CD8 cells for Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674583|NCT01327300|3080246|Superiority or Other||Mean Difference (Final Values)|-12.2||||0.33|||||||t-test, 2 sided|||Comparison of change in IBS-Quality of Life (IBS-QOL)from baseline after 12 weeks of intervention was made.|
1675540|NCT01309282|3082383|Superiority or Other|||||||0.2969|||||||Wilcoxon signed rank test||||
1674565|NCT01327547|3080185|Superiority or Other||Difference in LS Mean|-44.93||||0.0947|2-Sided|95.0|-97.72|7.87|||ANCOVA|||The above analysis is for CD38 expression on CD4 and CD8 cells for Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674566|NCT01327547|3080185|Superiority or Other||Difference in LS Mean|-56.06||||0.0153|2-Sided|95.0|-101.2|-10.92|||ANCOVA||Difference in LS Mean|The above analysis is for CD38 expression on CD4 and CD8 cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, HBV, PI-based regimen.|
1674567|NCT01327547|3080186|Superiority or Other||Difference in LS Mean|-31.86||||0.5571|2-Sided|95.0|-138.93|75.21|||ANCOVA|||The above analysis is for CD8+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.|
1674568|NCT01327547|3080186|Superiority or Other||Difference in LS Mean|-27.71||||0.3859|2-Sided|95.0|-90.71|35.29|||ANCOVA|||The above analysis is for CD4+ cells at Week 144. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.|
1674569|NCT01327547|3080186|Superiority or Other||Difference in LS Mean|-65.28||||0.1799|2-Sided|95.0|-161.07|30.5|||ANCOVA|||The above analysis is for CD8+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.|
1674570|NCT01327547|3080186|Superiority or Other||Difference in LS Mean|-48.26||||0.0669|2-Sided|95.0|-99.93|3.41|||ANCOVA|||The above analysis is for CD4+ cells at Week 96. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.|
1674571|NCT01327547|3080186|Superiority or Other||Difference in LS Mean|-21.96||||0.593|2-Sided|95.0|-103.05|59.12|||ANCOVA||Difference in LS Mean|The above analysis is for CD8+ cells at Week 48. Results are from an ANCOVA model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.|
1674572|NCT01327547|3080186|Superiority or Other||Difference in Least Square (LS) Mean|-41.12||||0.1174|2-Sided|95.0|-92.72|10.49|||ANCOVA||Difference in Least Square (LS) Mean|The above analysis is for CD4+ cells at week 48. Results are from an analysis of covariance (ANCOVA) model with change from baseline as the response variable and the following fixed effect model terms: treatment (Maraviroc or placebo), baseline value of the response variable, hepatitis B virus status (HBV), Protease inhibitor (PI)-based regimen.|
1674573|NCT01327547|3080187|Superiority or Other||Mean Difference (Final Values)|-0.083|||||2-Sided|95.0|-0.2421|0.0761|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 144 data presented here.|
1674574|NCT01327547|3080187|Superiority or Other||Mean Difference (Final Values)|-0.0255|||||2-Sided|95.0|-0.1784|0.1274|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 96 data presented here.|
1674575|NCT01327547|3080187|Superiority or Other||Difference in proportion|-0.015|||||2-Sided|95.0|-0.1484|0.1185|||||Difference in proportion: CMH approach weighted by HBV status and usage of PI regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The CMH approach was used. No formal hypothesis test was performed. Week 48 data presented here.|
1674576|NCT01327547|3080192|Superiority or Other||Mean Difference (Final Values)|-0.0177|||||2-Sided|95.0|-0.0805|0.0452|||||CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between maraviroc and placebo for the participants meeting secondary endpoint.||
1674577|NCT01327547|3080192|Superiority or Other||Mean Difference (Final Values)|-0.0167|||||2-Sided|95.0|-0.0653|0.0319|||||CMH approach weighted by HBV status and usage of PI regiment strata, is used to calculate the statistics. The point estimate and 95% CI are difference in proportions between MVC and placebo for the participants meeting secondary endpoint.||
1674578|NCT01327547|3080193|Superiority or Other||Difference in proportion|-0.002||||0.4598|2-Sided|95.0|-0.0417|0.0376|||Cochran-Mantel-Haenszel||Difference in proportion: CMH approach weighted by hepatitis B virus (HBV) status and usage of protease inhibitor (PI) regimen strata was used to calculate the statistics.|A stratified analysis was conducted by summarizing the difference in proportions adjusted for the randomization strata formed by crossing levels of stratification variables. The Cochran-Mantel-Haenszel (CMH) approach was used. No formal hypothesis test was performed.|
1674579|NCT01327339|3080214|Superiority or Other||percentage of participants|5.9|||||2-Sided|95.0|4.3|7.8|||||The estimated value represents the percentage of participants with an adverse event.||
1674580|NCT01327300|3080244|Superiority or Other|||||||0.55|||||||t-test, 2 sided|||Comparison of the lactulose/mannitol ratio is made after a 12 week intervention with mesalamine to 12 weeks of placebo.|
1674581|NCT01327300|3080245|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.57||95.0|||||t-test, 2 sided|||Comparison of change in HADS score between baseline and after 12 weeks of placebo is made.|
1674582|NCT01327300|3080245|Superiority or Other||Mean Difference (Final Values)|1.3||||0.71||95.0|||||t-test, 2 sided|||Comparison of the change in HADS score of baseline to 12 weeks of mesalamine is made.|
1675541|NCT01309282|3082384|Superiority or Other|||||||0.0904|||||||Wilcoxon signed rank test||||
1674584|NCT01327300|3080246|Superiority or Other||Mean Difference (Final Values)|11.0||||0.61|||||||t-test, 2 sided|||For the IBS QOL we compared the change in IBS-Quality of Life (IBS-QOL) after 12 weeks of mesalamine.|
1674585|NCT01327300|3080247|Superiority or Other||Mean Difference (Final Values)|17.0||||0.77|||||||t-test, 2 sided|||See prior description of the FBDSI score. Change in the FBDSI after 12 weeks of intervention is made using a two sided t-test.|
1674586|NCT01327300|3080247|Superiority or Other||Mean Difference (Final Values)|-14.5||||0.67|||||||t-test, 2 sided|Two-tailed P values are listed for baseline versus 12 weeks of mesalamine||"The FBDSI score is based on the severity of abdominal pian. Severity is rated as the following:~None= 0 points Mild= (1-36) Moderate =(37-110) Severe= (>110 points)"|
1674587|NCT01327300|3080248|Superiority or Other|||||||0.81|||||||Wilcoxon (Mann-Whitney)|Pearson's linear coefficient||The study tested three biomarkers and symptom domains at baseline and the end of 12 weeks of placebo using the Mann-Whitney test, as well as correlations between domains with Pearson’s linear correlation coefficient.|
1674588|NCT01327300|3080248|Superiority or Other|||||||0.873|||||||Wilcoxon (Mann-Whitney)|||Correlation coefficients were used for each of three biomarkers in relation to other biomarkers and to the questionnaires and patient's symptoms.|
1674589|NCT01327300|3080249|Superiority or Other||Mean Difference (Final Values)|2.22||||0.008||95.0|||||t-test, 2 sided|||Comparisons of mean difference in GIS scores between baseline and placebo is made below.|
1674590|NCT01327300|3080249|Superiority or Other||Mean Difference (Final Values)|2.72||||0.001||95.0|||||t-test, 2 sided|||"The GIS scoring system is from 1-7 with one being a worse outcome and 7 the better outcome.~Comparisons below list the p values for comparison of difference in GIS between baseline and mesalamine."|
1674591|NCT01327274|3080251|Other|Pre-treatment and post-treatment Pectus Severity Indices were compared using the Wilcoxon matched-pairs signed rank test.||||||0.486|||||||Wilcoxon (Mann-Whitney)||||
1674592|NCT01327157|3080254|Other|||||||0.01|||||||t-test, 1 sided||||
1674593|NCT01327157|3080255|Other|||||||0.705|||||||t-test, 1 sided||||
1674594|NCT01327157|3080256|Equivalence|The comparison among the groups, from the results obtained by the Visual Analog Scale (VAS), was done through analysis of variance models (ANOVA) with two factors. The comparison among the groups, in each period of the study (initial and final) was done through t test for two independent samples.|Mean Difference (Net)|2.4|Standard Deviation|1.44||0.002|2-Sided||||||t-test, 2 sided|||"We assessed the quality of oral functions in the last query to check the status of discomfort after ninety days in both groups, control and treatment, using VAS.~The statistical significance was considered to p<0.05 values and it was used the Minitab statistics software, 15.1 version, to get the results."|
1674595|NCT01327157|3080257|Equivalence|"Only the treatment group was analysed. The dental contacts were evaluated in models and gnathostats demarcated after the points were counted in the models before and after treatment If an increase in the number of dental contacts after occlusal adjustment was detected, in relation of the models.~The models are made in the first and last query, after four visits with one month interval between them."|Mean Difference (Net)|5.0|Standard Deviation|3.92|<|0.001|2-Sided||||||t-test, 2 sided|||The brand carbon mark was done on the treatment group in the first and last query.|
1674596|NCT01327157|3080258|Equivalence|The comparison among the groups, from the results obtained by the Visual Analog Scale (VAS), was done through analysis of variance models (ANOVA) with two factors.|Mean Difference (Net)|0.5||||0.524|2-Sided|||||Statistical significance was considered for values of p <0.05 and it was used The Minitab statistical software, version 15.1 to obtain the results.|t-test, 1 sided|The comparison between the groups in each study period (initial) was done through the t-test for two independent samples.||"We assessed the quality of oral functions in the first query to check the status of discomfort before treatment in both groups, using VAS..~Statistical significance was considered for values of p <0.05 and it was used The Minitab statistical software, version 15.1 to obtain the results"|
1674597|NCT01326533|3080336|Superiority or Other|||||||0.013|||||||ANCOVA|Adjusted for baseline value as covariate|||
1674598|NCT01326533|3080337|Superiority or Other||||||<|0.01|||||||ANCOVA|Adjusted for baseline value as covariate|||
1674599|NCT01325714|3080352|Superiority or Other||Results of F value of growth curve model|3.84||||0.01|2-Sided|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 456) = 3.84||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported mutuality over time.|
1674600|NCT01325714|3080353|Superiority or Other||Results of F value of growth curve model|0.11||||0.11|2-Sided|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 456) = 2.00||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver burden over time.|
1674601|NCT01325714|3080354|Superiority or Other||Results of F value of growth curve model|1.1||||0.35|2-Sided|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 457) = 1.10||Growth curve models were conducted to examine whether there were differences between treatment groups in change in pleasant events over time.|
1674602|NCT01325714|3080355|Superiority or Other||Results of F value of growth curve model|0.94||||0.42|2-Sided|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 453) = 0.94.||Growth curve models were conducted to examine whether there were differences between treatment groups in change in depression over time.|
1674603|NCT01325714|3080356|Superiority or Other||Results of F value of growth curve model|0.86||||0.62|2-Sided|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 409) = 0.59||Growth curve models were conducted to examine whether there were differences between treatment groups in change in patient-reported overall pain over time.|
1674604|NCT01325714|3080357|Superiority or Other||Results of F value of growth curve model|1.45||||0.23|2-Sided|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 455) = 1.45||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported overall pain over time.|
1674625|NCT01325623|3080366|Superiority or Other|||||||0.0024|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score|
1674605|NCT01325714|3080358|Superiority or Other||Results of F value of growth curve model|1.43||||0.23|2-Sided|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.|
1674606|NCT01325714|3080359|Superiority or Other||Results of F value of growth curve model|0.86||||0.46|2-Sided|||||P value of the interaction between treatment group and time (time coded as 0, 3, 6, 12).|Mixed Models Analysis|F (3, 455) = 0.86||Growth curve models were conducted to examine whether there were differences between treatment groups in change in caregiver reported worst pain over time.|
1674607|NCT01325714|3080360|Non-Inferiority or Equivalence|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen’s h = .4) between treatment groups in rate of aggression onset (the primary outcome) over a 1-year period, assuming 80% power and type I error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group (anticipated based on estimated rates from prior work) versus 19% for the treatment group|Hazard Ratio (HR)|0.84||||0.84|2-Sided|95.0|0.51|1.37||From discrete-time Cox regression time-to-event analyses|Regression, Cox|df = 1|The usual care arm is the reference group.|Examination of group differences in incidence of verbal aggression. We expected those in paved to have lower incidence of verbal aggression relative to those in enhanced usual care.|
1674608|NCT01325714|3080360|Non-Inferiority or Equivalence|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen’s h = .4) between treatment groups in rate of aggression onset over a 1-year period, assuming 80% power and T1 error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group versus 19% for the treatment group. Given this, our goal was to include 220 total participants (after 10% attrition: N = 198).|Hazard Ratio (HR)|0.77||||0.39|2-Sided|95.0|0.43|1.39||From discrete time-cox regression time-to-event analysis.|Regression, Cox|df = 1|The enhanced usual care arm is the reference group.|Comparison of incidence of non-verbal aggression between treatment groups.|
1674609|NCT01325714|3080360|Non-Inferiority or Equivalence|Power calculations were based on the ability to detect a small-to-moderate difference (Cohen’s h = .4) between treatment groups in rate of aggression onset over a 1-year period, assuming 80% power and T1 error rate of 5%. This differential rate in aggression onset is comparable to a 37% rate of aggression onset over a 1 year period for the control group versus 19% for the treatment group. Given this, our goal was to include 220 total participants (after 10% attrition: N = 198).|Hazard Ratio (HR)|0.71||||0.13|2-Sided|95.0|0.45|1.11||This is the p value from the discrete-time Cox regression time-to-event analyses|Regression, Cox|DF = 1|The enhanced usual care arm is the comparison group.|"Univariate time-to-event analyses, using discrete-time Cox regression models to evaluate differences between PAVeD and EU-PC in the primary outcome of incidence of aggression over time.~We expected that patients with dementia among dyads randomized to PAVeD arm would be less likely to develop aggression compared to those randomized to the enhanced usual care arm."|
1674610|NCT01325623|3080366|Superiority or Other|||||||0.0036|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score|
1674611|NCT01325623|3080366|Superiority or Other|||||||0.0826|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score|
1674612|NCT01325623|3080366|Superiority or Other|||||||0.9119|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.|||
1674613|NCT01325623|3080366|Superiority or Other|||||||0.261|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final Score|
1674614|NCT01325623|3080366|Superiority or Other|||||||0.1459|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score|
1674615|NCT01325623|3080366|Superiority or Other|||||||0.0823|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score|
1674616|NCT01325623|3080366|Superiority or Other|||||||0.2226|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score|
1674617|NCT01325623|3080366|Superiority or Other|||||||0.0683|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score|
1674618|NCT01325623|3080366|Superiority or Other|||||||0.0008|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score|
1674619|NCT01325623|3080366|Superiority or Other|||||||0.027|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score|
1674620|NCT01325623|3080366|Superiority or Other|||||||0.3115|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score|
1674621|NCT01325623|3080366|Superiority or Other|||||||0.0296|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive Functioning Final Score|
1674622|NCT01325623|3080366|Superiority or Other|||||||0.0002|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score|
1674623|NCT01325623|3080366|Superiority or Other|||||||0.0511|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score|
1674624|NCT01325623|3080366|Superiority or Other|||||||0.4464|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score|
1674626|NCT01325623|3080366|Superiority or Other|||||||0.0025|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score|
1674627|NCT01325623|3080366|Superiority or Other|||||||0.0642|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score|
1674628|NCT01325623|3080366|Superiority or Other|||||||0.5252|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score|
1674629|NCT01325623|3080366|Superiority or Other|||||||0.1293|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score|
1674630|NCT01325623|3080366|Superiority or Other|||||||0.0019|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score|
1674631|NCT01325623|3080366|Superiority or Other|||||||0.1363|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score|
1674632|NCT01325623|3080366|Superiority or Other|||||||0.2822|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score|
1674633|NCT01325623|3080366|Superiority or Other|||||||0.0139|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score|
1674634|NCT01325623|3080366|Superiority or Other|||||||0.0238|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score|
1674635|NCT01325623|3080366|Superiority or Other|||||||0.4964|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score|
1674636|NCT01325623|3080366|Superiority or Other|||||||0.6927|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score|
1674637|NCT01325623|3080366|Superiority or Other|||||||0.1353|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score|
1674638|NCT01325623|3080366|Superiority or Other|||||||0.0527|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score|
1674639|NCT01325623|3080366|Superiority or Other|||||||0.8701|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score|
1674640|NCT01325623|3080366|Superiority or Other|||||||0.4138|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score|
1674641|NCT01325623|3080366|Superiority or Other|||||||0.2365|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total Score|
1674642|NCT01325623|3080366|Superiority or Other|||||||0.4189|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Quality of Life Final Score|
1674643|NCT01325623|3080366|Superiority or Other|||||||0.1877|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Seizure Worry Final Score|
1674644|NCT01325623|3080366|Superiority or Other|||||||0.4954|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Medication Effects Final Score|
1674645|NCT01325623|3080366|Superiority or Other|||||||0.8532|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Cognitive functioning Final Score|
1674646|NCT01325623|3080366|Superiority or Other|||||||0.01|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Social Functioning Final Score|
1674647|NCT01325623|3080366|Superiority or Other|||||||0.9376|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Emotional well being Final Score|
1674648|NCT01325623|3080366|Superiority or Other|||||||0.6562|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Energy/Fatigue Final Score|
1674649|NCT01325623|3080366|Superiority or Other|||||||0.2079|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||QOLIE Overall Total|
1674650|NCT01325623|3080370|Superiority or Other|||||||0.8537|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score|
1674651|NCT01325623|3080370|Superiority or Other|||||||0.964|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score|
1674652|NCT01325623|3080370|Superiority or Other|||||||0.5014|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score|
1674653|NCT01325623|3080370|Superiority or Other|||||||0.7179|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score|
1675542|NCT01309282|3082385|Superiority or Other|||||||0.0225|||||||Wilcoxon signed rank test||||
1674654|NCT01325623|3080370|Superiority or Other|||||||0.5928|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score|
1674655|NCT01325623|3080370|Superiority or Other|||||||0.0067|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score|
1674656|NCT01325623|3080370|Superiority or Other|||||||0.0328|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score|
1674657|NCT01325623|3080370|Superiority or Other|||||||0.6876|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score|
1674658|NCT01325623|3080370|Superiority or Other|||||||0.4456|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score|
1674659|NCT01325623|3080370|Superiority or Other|||||||0.8622|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score|
1674660|NCT01325623|3080370|Superiority or Other|||||||0.6653|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score|
1674661|NCT01325623|3080370|Superiority or Other|||||||0.5035|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score|
1674662|NCT01325623|3080370|Superiority or Other|||||||0.1473|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score|
1674663|NCT01325623|3080370|Superiority or Other|||||||0.3339|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score|
1674664|NCT01325623|3080370|Superiority or Other|||||||0.153|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score|
1674665|NCT01325623|3080370|Superiority or Other|||||||0.6094|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score|
1674666|NCT01325623|3080370|Superiority or Other|||||||0.6869|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score|
1674667|NCT01325623|3080370|Superiority or Other|||||||0.179|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score|
1674668|NCT01325623|3080370|Superiority or Other|||||||0.2082|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score|
1674669|NCT01325623|3080370|Superiority or Other|||||||0.0679|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score|
1674670|NCT01325623|3080370|Superiority or Other|||||||0.3191|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score|
1674671|NCT01325623|3080370|Superiority or Other|||||||0.2309|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score|
1674672|NCT01325623|3080370|Superiority or Other|||||||0.1123|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score|
1674673|NCT01325623|3080370|Superiority or Other|||||||0.1305|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score|
1674674|NCT01325623|3080370|Superiority or Other|||||||0.1273|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score|
1674675|NCT01325623|3080370|Superiority or Other|||||||0.1106|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score|
1674676|NCT01325623|3080370|Superiority or Other|||||||0.0019|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score|
1674677|NCT01325623|3080370|Superiority or Other|||||||0.0511|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score|
1674678|NCT01325623|3080370|Superiority or Other|||||||0.3898|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Cognitive Recovery Score|
1674679|NCT01325623|3080370|Superiority or Other|||||||0.1311|||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Physical Recovery Score|
1674680|NCT01325623|3080370|Superiority or Other|||||||0.447|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Postictal Emotional Recovery Score|
1674681|NCT01325623|3080370|Superiority or Other|||||||0.3639|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Severity Score|
1674758|NCT01323855|3080599|Non-Inferiority or Equivalence|Geometric Mean Ratio (GMR) is contained within the interval [0.50, 2.00]|GMR|1.19|||||2-Sided|90.0|0.54|2.62|||||Severe CRI/Healthy||
1674682|NCT01325623|3080370|Superiority or Other|||||||0.2831|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Overall Recovery Score|
1674683|NCT01325623|3080370|Superiority or Other|||||||0.0942|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||Activity During Seizures Score|
1674684|NCT01325623|3080370|Superiority or Other|||||||0.1529|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero.||SSQ Total Score|
1674685|NCT01325623|3080371|Superiority or Other|||||||0.5|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months|
1674686|NCT01325623|3080371|Superiority or Other|||||||0.5|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months|
1674687|NCT01325623|3080371|Superiority or Other|||||||0.125|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months|
1674688|NCT01325623|3080371|Superiority or Other||||||>|0.999|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months|
1674689|NCT01325623|3080371|Superiority or Other||||||>|0.999|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months|
1674690|NCT01325623|3080371|Superiority or Other||||||>|0.5|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge|
1674691|NCT01325623|3080371|Superiority or Other||||||>|0.5|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months|
1674692|NCT01325623|3080371|Superiority or Other||||||>|0.188|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months|
1674693|NCT01325623|3080371|Superiority or Other||||||>|0.5|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months|
1674694|NCT01325623|3080371|Superiority or Other||||||>|0.5|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months|
1674695|NCT01325623|3080371|Superiority or Other||||||>|0.999|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months|
1674696|NCT01325623|3080371|Superiority or Other||||||>|0.5|||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge|
1674697|NCT01325623|3080371|Superiority or Other||||||>|0.029|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months|
1674698|NCT01325623|3080371|Superiority or Other||||||>|0.009|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months|
1674699|NCT01325623|3080371|Superiority or Other||||||>|0.008|||||||s|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months|
1674700|NCT01325623|3080371|Superiority or Other||||||>|0.012|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 Months|
1674701|NCT01325623|3080371|Superiority or Other||||||>|0.106|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months|
1674702|NCT01325623|3080371|Superiority or Other||||||<|0.001|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge|
1674703|NCT01325623|3080371|Superiority or Other||||||<|0.906|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 24 Months|
1674704|NCT01325623|3080371|Superiority or Other||||||<|0.188|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 18 Months|
1674705|NCT01325623|3080371|Superiority or Other||||||<|0.906|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 12 Months|
1674706|NCT01325623|3080371|Superiority or Other||||||>|0.999|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 6 months|
1674707|NCT01325623|3080371|Superiority or Other||||||>|0.156|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to 3 Months|
1674708|NCT01325623|3080371|Superiority or Other||||||>|0.375|||||||Signed Rank Test|Null hypothesis: change from the baseline is equal to zero. The alternative hypothesis: change from the baseline is not equal to zero||Baseline to EMU Discharge|
1674709|NCT01325584|3080380|Superiority|||||||0.48|||||||Wilcoxon (Mann-Whitney)||||
1674710|NCT01325584|3080381|Superiority|||||||0.53|||||||Wilcoxon (Mann-Whitney)||||
1674711|NCT01325584|3080383|Superiority|||||||0.07|||||||Wilcoxon (Mann-Whitney)||||
1674759|NCT01323790|3080600|Superiority or Other||LS mean difference|-0.49|||<|0.001|2-Sided|95.0|-0.73|-0.25|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674712|NCT01325311|3080429|Superiority or Other|||||||0.922|||||||t-test, 2 sided|||Using the Student t-test. If the normality assumption is tenuous, an appropriate transformation of the data such as logarithm will be considered for Student t-test or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison.|
1674713|NCT01325207|3080436|Other||||||||||||||||||The Maximum Tolerated Dose (MTD) was determined to be 80mg IT every two weeks. This is based on no DLTs being seeing in Cohorts 1-4 with lower doses and 1 DLT out of 7 patients observed at 80mg IT in Cohort 5.
1674714|NCT01324999|3080445|Other|||||||0.44|||||||t-test, 2 sided|||comparison of baseline to week 24|
1674715|NCT01324999|3080446|Other|||||||0.92|||||||t-test, 2 sided|||comparing baseline to week 24|
1674716|NCT01324999|3080447|Other|||||||0.68|||||||t-test, 2 sided|||Comparing Baseline to week 24.|
1674717|NCT01324999|3080448|Other|||||||0.19|||||||t-test, 2 sided|||comparing baseline to week 24|
1674718|NCT01324999|3080449|Other|||||||0.99|||||||t-test, 2 sided||||
1674719|NCT01324999|3080450|Other|||||||0.34|||||||t-test, 2 sided||||
1674720|NCT01324999|3080451|Other|||||||0.68|||||||t-test, 2 sided|||Comparing baseline to week 24.|
1674721|NCT01324882|3080460|Other|||||||1|||||||Fisher Exact||||
1674722|NCT01324687|3080469|Superiority or Other||Rate ratio|0.8387||||0.017|2-Sided|95.0|0.7261|0.9689|||GEE / Poisson regression models|||Rate ratio of ED use rate of the intervention group as compared to the control group.|
1674723|NCT01324453|3080488|Superiority|||||||0.77|||||||Kruskal-Wallis||||
1674724|NCT01324453|3080489|Superiority|||||||0.58|||||||Kruskal-Wallis||||
1674725|NCT01324453|3080490|Superiority|||||||1|||||||Kruskal-Wallis||||
1674726|NCT01324453|3080491|Superiority|||||||0.86|||||||Kruskal-Wallis||||
1674727|NCT01324453|3080492|Superiority|||||||0.58|||||||t-test, 2 sided||||
1674728|NCT01324453|3080493|Superiority|||||||0.45|||||||Chi-squared||||
1674729|NCT01324453|3080494|Superiority|||||||0.81|||||||Kruskal-Wallis||||
1674730|NCT01324453|3080495|Superiority|||||||0.9|||||||Kruskal-Wallis||||
1674731|NCT01324349|3080510|Superiority or Other||Risk Difference (RD)|10.5||||0.5029|||||||Fisher Exact||Risk difference equals percent of subjects with any treatment emergent adverse events in control group minus percent of subjects with any treatment emergent adverse events in Hemostatic Patch group.|The incidence of subjects experiencing treatment-emergent adverse events (TEAEs) (defined under this protocol as Adverse Events) was summarized by MedDRA system organ class (SOC) and preferred term (PT) for each treatment group for the safety population. Tests for differences between the two treatments in the proportion of subjects experiencing any adverse event were made using Fisher’s Exact Test.|
1674732|NCT01324349|3080511|Superiority or Other||Risk Difference (RD)|23.2||||0.0339|2-Sided|95.0|1.9|47.3|||Suissa and Shuster test||Risk difference equals percentage hemostasis for Hemostatic Patch minus percentage hemostasis for control.|The secondary effectiveness endpoint was hemostasis within 3 minutes. The number and percentage of subjects who achieved hemostasis within 3 minutes are presented for each treatment group. The proportions of subjects who achieved hemostasis within 3 minutes were compared between treatments using the Suissa and Shuster test. Additionally, a 95% Blyth-Still-Casella confidence interval for the true proportion was computed for each treatment.|
1674733|NCT01324349|3080512|Superiority or Other||Median Difference (Final Values)|2.0|||<|0.0001|||||||Log Rank||Median difference equals control median minus Hemostatic Patch median in minutes.|The primary effectiveness endpoint was time to hemostasis. The Kaplan-Meier method was used to estimate the survival distribution and to obtain the estimated median time to hemostasis for each treatment. Subjects who did not achieve hemostasis by 10 minutes were to be censored as of that time point. For each treatment, 95% Brookmeyer-Crowley confidence intervals for the median were computed based upon the sign test.|
1674734|NCT01324323|3080517|Superiority or Other (legacy)||Median Difference (Final Values)|-0.15||||0.791|2-Sided|90.0|-1.0|1.01|||Wilcoxon signed-rank|||Note: The median, median difference (“romidepsin + rifampin” minus “romidepsin”) and 90% CI of the median difference are from Hodges-Lehmann Estimate. The P-value is from Wilcoxon signed-rank test.|
1674735|NCT01324323|3080518|Superiority or Other (legacy)||Ratio of the Geometric Mean|159.1|||||2-Sided|90.0|135.8|186.5|||||Ratio (“Romidepsin + rifampin”/“Romidepsin”) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values.||
1674736|NCT01324323|3080519|Superiority or Other (legacy)||Ratio of the Geometric Mean|179.6|||||2-Sided|90.0|160.5|201.0|||||Ratio (“Romidepsin + rifampin”/“Romidepsin”) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values.||
1674737|NCT01324323|3080520|Superiority or Other (legacy)||Ratio of the Geometric Mean|178.3|||||2-Sided|90.0|159.4|199.4|||||Ratio (“Romidepsin + rifampin”/“Romidepsin”) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values.||
1674738|NCT01324323|3080521|Superiority or Other (legacy)||Ratio of the Geometric Mean (%)|179.3|||||2-Sided|90.0|160.3|200.7|||||Ratio (“Romidepsin + rifampin”/“Romidepsin”) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values.||
1674739|NCT01324310|3080526|Superiority or Other (legacy)||Median Difference (Final Values)|0.0||||0.7422|2-Sided|90.0|-0.485|0.095|||Wilcoxon signed- rank|||Note: The median, median difference (“romidepsin + ketoconazole” minus “romidepsin”) and 90% CI of the median difference are from Hodges-Lehmann Estimate. The P-value is from Wilcoxon signed-rank test.|
1674740|NCT01324310|3080527|Superiority or Other (legacy)||Ratio of the Geometric Mean|109.5|||||2-Sided|90.0|94.9|126.4|||||||
1674741|NCT01324310|3080528|Superiority or Other (legacy)||Ratio of the Geometric Mean|124.6|||||2-Sided|90.0|109.0|142.4|||||||
1674742|NCT01324310|3080529|Superiority or Other (legacy)||Ratio of the Geometric Mean|123.7|||||2-Sided|90.0|109.6|139.6|||||||
1674743|NCT01324310|3080530|Superiority or Other (legacy)||Ratio of Geometric Mean|124.4|||||2-Sided|90.0|110.2|140.5|||||Geometric means ratio (“Romidepsin + Ketoconazole”/“Romidepsin”) and 90% CI of the ratio of geometric means are from an ANOVA model with treatment as fixed effect and subject as random effect on the natural log transformed PK values.||
1674744|NCT01324102|3080536|Superiority or Other|||||||0.056||||||F=4.07. The a priori threshold for statistical significance is .05. The .056 value does not exceed it. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row/category of insomnia.|ANOVA|||Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing insomnia scores pre-Yoga versus post-Yoga, between the two groups. This measures changes in insomnia.|
1674745|NCT01324102|3080536|Superiority or Other|||||||0.004||||||The a priori threshold for statistical significance is .05. The .004 value exceeds this value. There was only one comparison, so there was no adjustment for multiple comparison. This analysis refers to the row and category of anxiety.|ANOVA|F=10.25||Repeated measure Analysis of Variance (ANOVA) with null hypothesis of no group differences, comparing anxiety scores pre-Yoga versus post-Yoga, between the two groups for changes in anxiety.|
1674746|NCT01323972|3080546|Non-Inferiority|Non-inferiority was demonstrated if one month post Dose 3, the upper limit (UL) of the 2-sided 95% CI of the GMT ratio of the pilot scale lot (Control Group) over the pooled commercial scale lots (Pooled Log Group) was below 2.|GMT ratio|0.95||||||95.0|0.79|1.15||||||Demonstration of non-inferiority of the commercial scale lots of GSK 257049 to the pilot scale lot in terms of anti-Circumsporozoite (anti-CS) immunogenicity.|
1674747|NCT01323972|3080546|Other||GMT ratio|0.8||||||95.0|0.64|1.0|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within [0.5, 2].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 2 and GSK 257049-Lot 3 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.|
1674748|NCT01323972|3080546|Other||GMT ratio|1.06|||||2-Sided|95.0|0.85|1.32|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within [0.5, 2].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 1 and GSK 257049-Lot 3 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.|
1674749|NCT01323972|3080546|Other||GMT ratio|1.32|||||2-Sided|95.0|1.06|1.65|||||Consistency was demonstrated if one month post Dose 3, the 2-sided 95% confidence interval (CI) of the geometric mean titer (GMT) ratio between all pairs of lots were within [0.5, 2].|Demonstration of the lot-to-lot consistency between GSK 257049-Lot 1 and GSK 257049-Lot 2 in terms of anti-Circumsporozoite (anti-CS) immunogenicity.|
1674750|NCT01323959|3080561|Superiority or Other||Percentage of subjects seroprotected|84.1|||||2-Sided|95.0|73.3|91.8|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result <0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.|
1674751|NCT01323959|3080561|Superiority or Other||Percentage of subjects seroprotected|79.4|||||2-Sided|95.0|67.9|88.3|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result <0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.|
1674752|NCT01323959|3080561|Superiority or Other||Percentage of subjects seroprotected|92.1|||||2-Sided|95.0|82.4|97.4|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result <0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to dose in study NCT01277705. Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing.|
1674753|NCT01323959|3080563|Superiority or Other||Percentage of subjects seroprotected|100.0|||||2-Sided|95.0|94.8|100.0|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result <0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.|
1674754|NCT01323959|3080563|Superiority or Other||Percentage of subjects seroprotected|95.7|||||2-Sided|95.0|87.8|99.1|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result <0.1 IU/mL) subjects was above 80%.|The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, one month after the booster dose, in at least 80% of the subjects against diphtheria.|
1674755|NCT01323959|3080563|Superiority or Other||Percentage of subjects seroprotected|96.8|||||2-Sided|95.0|89.0|99.6|||||The pre-specified lower limit (LL) of the 95% confidence interval (CI) for the percentage of seroprotected (Anti-D concentrations ≥ 0.1 IU/mL by ELISA or ≥ 0.01 IU/mL by VERO-cell when subjects with ELISA result <0.1 IU/mL) subjects was above 80%.|"The objective of the analysis was to demonstrate that a booster dose of Boostrix™ Polio vaccine, administered to adults 10 years after a dose of Boostrix™ Polio vaccine or co-administered Boostrix™ + Poliorix™ vaccines, elicited seroprotective antibody concentrations, 1 month after the booster dose, in at least 80% of the subjects against diphtheria.~Samples were analysed both with ELISA (enzyme-linked immunosorbent assay), and VERO-cell (African green monkey kidney cell) neutralisation testing."|
1674756|NCT01323855|3080597|Non-Inferiority or Equivalence|GMR is contained within the interval [0.50, 2.00]|GMR|2.63|||||2-Sided|90.0|1.38|5.04|||||Mild CRI/Healthy||
1674757|NCT01323855|3080598|Non-Inferiority or Equivalence|GMR is contained within the interval [0.50, 2.00]|GMR|1.3|||||2-Sided|90.0|0.59|2.87|||||Moderate CRI/Healthy||
1674760|NCT01323790|3080600|Superiority or Other||LS mean difference|-0.31|||<|0.011|2-Sided|95.0|-0.54|-0.07|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674761|NCT01323790|3080601|Superiority or Other||LS mean difference|-0.38|||<|0.001|2-Sided|95.0|-0.56|-0.21||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674762|NCT01323790|3080601|Superiority or Other||LS mean difference|-0.27|||<|0.002|2-Sided|95.0|-0.44|-0.1||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674763|NCT01323790|3080601|Superiority or Other||LS mean difference|-0.24|||<|0.001|2-Sided|95.0|-0.37|-0.1||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674764|NCT01323790|3080601|Superiority or Other||LS mean difference|-0.11|||<|0.095|2-Sided|95.0|-0.24|0.02||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674765|NCT01323790|3080601|Superiority or Other||LS mean difference|0.09|||<|0.236|2-Sided|95.0|-0.06|0.25||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674766|NCT01323790|3080601|Superiority or Other||Slope|0.05|||<|0.552|2-Sided|95.0|-0.11|0.2||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674767|NCT01323790|3080601|Superiority or Other||LS mean difference|-0.18|||<|0.011|2-Sided|95.0|-0.32|-0.04||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674768|NCT01323790|3080601|Superiority or Other||LS mean difference|-0.12|||<|0.08|2-Sided|95.0|-0.26|0.01||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674769|NCT01323790|3080603|Superiority or Other||LS mean difference|1.04|||<|0.001|2-Sided|95.0|0.58|1.51|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674770|NCT01323790|3080603|Superiority or Other||LS mean difference|0.52|||<|0.028|2-Sided|95.0|0.06|0.98|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674771|NCT01323790|3080604|Superiority or Other||LS mean difference|10.43|||<|0.001|2-Sided|95.0|6.03|14.84|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674772|NCT01323790|3080604|Superiority or Other||LS mean difference|6.72|||<|0.002|2-Sided|95.0|2.37|11.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674773|NCT01323790|3080605|Superiority or Other||LS mean difference|0.45|||<|0.001|2-Sided|95.0|0.29|0.62|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674774|NCT01323790|3080605|Superiority or Other||LS mean difference|0.28|||<|0.001|2-Sided|95.0|0.12|0.45|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674775|NCT01323790|3080606|Superiority or Other||LS mean difference|-0.32|||<|0.001|2-Sided|95.0|-0.45|-0.18|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674776|NCT01323790|3080606|Superiority or Other||LS mean difference|-0.19|||<|0.005|2-Sided|95.0|-0.32|-0.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674777|NCT01323790|3080607|Superiority or Other||Ls mean difference|0.68|||<|0.001|2-Sided|95.0|0.37|0.98|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674778|NCT01323790|3080607|Superiority or Other||LS mean difference|0.39|||<|0.01|2-Sided|95.0|0.09|0.69|||Mixed Models Analysis|||Analysis via Mixed Model Repeated Measures (MMRM) with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1674779|NCT01323790|3080609|Superiority or Other||Risk Ratio (RR)|1.489||||0.014|2-Sided|95.0|1.078|2.058||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel||||
1674806|NCT01323582|3080643|Superiority or Other||Mean Difference (Net)|-15.0|Standard Error of the Mean|6.61||0.034|2-Sided|95.0|-28.7|-1.26|||t-test, 2 sided||Negative values suggest shorter emptying time post-treatment.||
1674780|NCT01323790|3080609|Superiority or Other||Risk Ratio (RR)|1.35||||0.074|2-Sided|95.0|0.967|1.884||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel||||
1674781|NCT01323790|3080610|Superiority or Other||Risk Ratio (RR)|1.348||||0.021|2-Sided|95.0|1.045|1.739|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).|
1674782|NCT01323790|3080610|Superiority or Other||Risk Ratio (RR)|1.188||||0.202|2-Sided|95.0|0.911|1.548|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).|
1674783|NCT01323673|3080620|Superiority or Other|||||||0.151||||||Cochran-Mantel-Haenszel (CMH) test stratified by center was used for analysis.|Cochran-Mantel-Haenszel||||
1674784|NCT01323660|3080625|Superiority or Other||Least squares mean difference|0.261|||<|0.001|2-Sided|95.0|0.22|0.303|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.||
1674785|NCT01323660|3080625|Superiority or Other||Least squares mean difference|0.243|||<|0.001|2-Sided|95.0|0.202|0.284|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.||
1674786|NCT01323660|3080625|Superiority or Other||Least squares mean difference|0.15|||<|0.001|2-Sided|95.0|0.098|0.201|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.||
1674787|NCT01323660|3080625|Superiority or Other||Least squares mean difference|0.006|||<|0.849|2-Sided|95.0|-0.055|0.067|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg.||
1674788|NCT01323660|3080625|Superiority or Other||Least squares mean difference|0.132|||<|0.001|2-Sided|95.0|0.081|0.183|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.||
1674789|NCT01323660|3080625|Superiority or Other||Least squares mean difference|0.099|||<|0.001|2-Sided|95.0|0.041|0.157|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.||
1674790|NCT01323660|3080625|Superiority or Other||Least squares mean difference|0.112|||<|0.001||95.0|0.061|0.163|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.||
1674791|NCT01323660|3080625|Superiority or Other||Least squares mean difference|0.255|||<|0.001|2-Sided|95.0|0.193|0.318|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.||
1674792|NCT01323660|3080625|Superiority or Other||Least squares mean difference|0.144|||<|0.001|2-Sided|95.0|0.086|0.203|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.||
1674793|NCT01323660|3080626|Superiority or Other||Least squares mean difference|65.8||||0.005|2-Sided|95.0|20.3|111.3|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus Placebo.||
1674794|NCT01323660|3080626|Superiority or Other||Least squares mean difference|69.4||||0.003|2-Sided|95.0|24.5|114.4|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus Placebo.||
1674795|NCT01323660|3080626|Superiority or Other||Least squares mean difference|35.2||||0.233|2-Sided|95.0|-22.7|93.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus VI 25 µg.||
1674796|NCT01323660|3080626|Superiority or Other||Least squares mean difference|-8.9||||0.801|2-Sided|95.0|-77.8|60.1||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 125/25 µg minus UMEC 125 µg||
1674797|NCT01323660|3080626|Superiority or Other||Least squares mean difference|38.8||||0.187|2-Sided|95.0|-18.9|96.5||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus VI 25 µg.||
1674798|NCT01323660|3080626|Superiority or Other||Least squares mean difference|44.4||||0.188|2-Sided|95.0|-21.8|110.6||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC/VI 62.5/25 µg minus UMEC 62.5 µg.||
1674799|NCT01323660|3080626|Superiority or Other||Least squares mean difference|30.6||||0.295|2-Sided|95.0|-26.8|88.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=VI 25 µg minus Placebo.||
1674800|NCT01323660|3080626|Superiority or Other||Least squares mean difference|74.7||||0.033|2-Sided|95.0|6.0|143.4||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 125 µg minus Placebo.||
1674801|NCT01323660|3080626|Superiority or Other||Least squares mean difference|25.0||||0.456|2-Sided|95.0|-41.0|91.0||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least square mean change difference=UMEC 62.5 µg minus Placebo.||
1674802|NCT01323634|3080636|Superiority or Other||Least square mean difference|0.08|||<|0.001|2-Sided|95.0|0.037|0.124|||ANCOVA||||
1674803|NCT01323621|3080638|Superiority or Other||Least squares mean difference|0.029||||0.267||95.0|-0.022|0.08|||ANCOVA||ANCOVA analysis was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.||
1674804|NCT01323582|3080641|Superiority or Other||Median Difference (Net)|-6.4|Standard Error of the Mean|2.2||0.0083|2-Sided|95.0|-10.97|-1.83|||t-test, 2 sided||Lower scores are favorable.||
1674805|NCT01323582|3080642|Superiority or Other||Mean Difference (Net)|-5.32|Standard Error of the Mean|1.98||0.015|2-Sided|95.0|-9.48|-1.16|||t-test, 2 sided||Lower scores are favorable.||
1674842|NCT01323010|3080712|Superiority or Other|||||||0.15|||||||ANOVA|Method: ANOVA with repetead measures for non parametric data proposed by Brunner and Piri.|||
1674807|NCT01323582|3080644|Superiority or Other||Mean Difference (Net)|-11.8|Standard Error of the Mean|9.1||0.21|2-Sided|95.0|-30.9|7.3|||t-test, 2 sided||Negative values suggest shorter emptying time post-treatment.||
1674808|NCT01323582|3080645|Superiority or Other||Mean Difference (Net)|-1.49|Standard Error of the Mean|5.7||0.8|2-Sided|95.0|-13.9|10.9|||t-test, 2 sided|Satterthwaite Corrected t-test|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.||
1674809|NCT01323582|3080646|Superiority or Other||Median Difference (Net)|0.35|Standard Error of the Mean|2.3||0.88|2-Sided|95.0|-4.58|5.19|||t-test, 2 sided|Satterthwaite correction for unequal standard deviations was used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Half of the period 2 minus period 1 differences were used, since the difference between these two derived means is an unbiased estimate of the effect size.|
1674810|NCT01323582|3080647|Superiority or Other||Mean Difference (Net)|1.3|Standard Error of the Mean|2.8||0.65||95.0|-4.8|7.5|||t-test, 2 sided|Satterthwaite Correction used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Study planned to accrue 50 subjects, but due to difficult recruitment was not able to meet its objective.|
1674811|NCT01323582|3080648|Superiority or Other||Mean Difference (Net)|3.6|Standard Error of the Mean|11.7||0.76|2-Sided|95.0|-21.5|28.6|||t-test, 2 sided|Satterthwaite corrected t-test was used|A positive (negative) value would suggest AZI values would tend to be larger (smaller) than EZ values.|Study planned to accrue 50 subjects, but due to difficult recruitment was not able to meet its objective.|
1674812|NCT01323270|3080678|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||2-Sided|95.0|-1.1|1.1||||||Poliovirus type 3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.|
1674813|NCT01323270|3080678|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||2-Sided|95.0|-1.1|1.1||||||Poliovirus type 2: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.|
1674814|NCT01323270|3080678|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||2-Sided|95.0|-1.1|1.1||||||Poliovirus type 1: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.|
1674815|NCT01323270|3080678|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 10%.|Percent difference|-1.2|||||2-Sided|95.0|-3.6|0.8||||||Pertussis fimbrial agglutinogens types 2+3: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.|
1674816|NCT01323270|3080678|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||2-Sided|95.0|-1.1|1.1||||||Pertussis pertactin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.|
1674817|NCT01323270|3080678|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||2-Sided|95.0|-1.1|1.1||||||Pertussis filamentous hemagglutinin: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.|
1674818|NCT01323270|3080678|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 10%.|Percent difference|-1.3|||||2-Sided|95.0|-4.7|1.9||||||Pertussis toxoid: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.|
1674819|NCT01323270|3080678|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||2-Sided|95.0|-1.1|1.1||||||Tetanus: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.|
1674820|NCT01323270|3080678|Non-Inferiority or Equivalence|The non-inferiority criteria margin was 10%.|Percent difference|0.0|||||2-Sided|95.0|-1.6|1.5||||||Diphtheria: Exact 2-sided confidence interval (based on Chan and Zhang) was reported for the difference in proportions, expressed as a percentage.|
1674821|NCT01323192|3080679|Superiority or Other|||||||0.4041|||||||ANCOVA||||
1674822|NCT01323192|3080680|Superiority or Other||Difference in least square means|-6.9|Standard Error of the Mean|1.83||0.0003|||||||ANCOVA||LS mean of JNS001 minus LS mean of Placebo||
1674823|NCT01323192|3080681|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1674824|NCT01323192|3080682|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1674825|NCT01323192|3080683|Superiority or Other||Difference in least square means|-6.9|Standard Error of the Mean|1.83||0.0002|||||||ANCOVA||LS mean of JNS001 minus LS mean of Placebo||
1674826|NCT01323192|3080684|Superiority or Other||Difference in least square means|-4.5|Standard Error of the Mean|1.1|<|0.0001|2-Sided|95.0|-6.7|-2.4|||ANCOVA||LS mean of JNS001 minus LS mean of Placebo||
1674827|NCT01323010|3080693|Superiority or Other|||||||0.03|||||||Chi-squared||||
1674828|NCT01323010|3080694|Superiority or Other|||||||0.203|||||||Chi-squared, Corrected||||
1674829|NCT01323010|3080695|Superiority or Other|||||||0.195|||||||Chi-squared||||
1674830|NCT01323010|3080696|Superiority or Other|||||||0.892|||||||Wilcoxon (Mann-Whitney)||||
1674831|NCT01323010|3080699|Superiority or Other|||||||0.905|||||||ANOVA||||
1674832|NCT01323010|3080700|Superiority or Other|||||||0.284|||||||ANOVA||||
1674833|NCT01323010|3080701|Superiority or Other|||||||0.235|||||||ANOVA||||
1674834|NCT01323010|3080702|Superiority or Other|||||||0.723|||||||ANOVA||||
1674835|NCT01323010|3080703|Superiority or Other|||||||0.046|||||||ANOVA||||
1674836|NCT01323010|3080704|Superiority or Other|||||||0.436|||||||ANOVA||||
1674837|NCT01323010|3080705|Superiority or Other|||||||0.165|||||||ANOVA||||
1674838|NCT01323010|3080706|Superiority or Other|||||||0.164|||||||ANOVA|Method: ANOVA with repetead measures for non paramteric data proposed by Brunner and Piri.|||
1674839|NCT01323010|3080708|Superiority or Other|||||||0.122|||||||ANOVA||||
1674840|NCT01323010|3080710|Superiority or Other|||||||0.108|||||||ANOVA||||
1674841|NCT01323010|3080711|Superiority or Other|||||||0.042|||||||Wilcoxon (Mann-Whitney)||||
1674843|NCT01323010|3080713|Superiority or Other|||||||0.591|||||||t-test, 2 sided||||
1674846|NCT01322633|3080724|Superiority or Other||Hazard Ratio (HR)|1.06|||||2-Sided|95.0|0.93|1.21||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.|
1674847|NCT01322633|3080725|Superiority or Other||Hazard Ratio (HR)|0.95|||||2-Sided|95.0|0.65|1.4||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.|
1674848|NCT01322633|3080726|Superiority or Other||Hazard Ratio (HR)|0.68|||||2-Sided|95.0|0.24|1.93||||||Analysis was based on hazard ratio using Cox proportional hazard regression method adjusted for sex, age, cumulative PPI dose, total years of PPI treatment, diabetes, hepatitis C, hepatitis B and year of index date.|
1674849|NCT01322490|3080743|Superiority|Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.|Odds Ratio (OR)|0.8941|||||2-Sided|95.0|0.6647|1.2026|||||The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.||
1674850|NCT01322490|3080743|Superiority|Odds Ratio and Wald 95% CI estimates are for odds of alive without event for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control and are from a logistic regression model with Treatment Arm included in model stratified by randomization strata.|Odds Ratio (OR)|0.9588|||||2-Sided|95.0|0.7144|1.2867|||||The Alive Without Event endpoint was analyzed using stratified logistic regression. The 95% CI on the odds ratio estimate was computed as the measure of the magnitude of effect.||
1674851|NCT01322490|3080744|Superiority|One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.||||||0.5885||||||The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.|Log Rank|The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.|||
1674852|NCT01322490|3080744|Superiority|One-sided p-value is from a stratified log-rank test for PROSTVAC-V/F-TRICOM + GM-CSF placebo vs. Placebo Control with Treatment Arm included in model. Stratification is by randomization strata.||||||0.4742||||||The overall type-one error probability for the entire trial was designed as a one-sided P=0.025. There were two main overall comparisons, which necessitated a type-one error probability to 0.0125 for each comparison using a Bonferroni correction.|Log Rank|The primary analysis method was a stratified log-rank test, and was performed using the ITT Set analyzing data according to the randomized arm.|||
1674853|NCT01322347|3080762|Superiority or Other||Difference in LS Means between SFP & PBO|3.6|Standard Error of the Mean|1.39||0.011|2-Sided|95.0||||LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.|ANCOVA||||
1674854|NCT01322009|3080769|Superiority or Other||||||>|0.05|||||||ANOVA|Analysis run over study period but data entered only for the 6 h time point|||
1674855|NCT01321749|3080774|Superiority or Other||||||<|0.05|||||||Log Rank||||
1674856|NCT01321554|3080794|Superiority or Other (legacy)||Cox Proportional Hazard|0.21|||||2-Sided|99.0|0.14|0.31|||||||
1674857|NCT01321073|3080795|Superiority||||||<|0.0001|||||||1-sample exact test for Poisson rate|||The rate of catheter-related complications per 1000 patient-days was compared to a pre-specified value of 2.5 / 1000 days. This was calculated based on published complication rates in PAH that included central venous catheter systemic bloodstream infections (0.43-1.13), site infections (0.26-0.87), and complications from catheter thrombosis, mechanical dysfunction, or catheter dislocation in the general central venous catheter population (0.36-0.51). The sum of the upper rates is 2.5.|
1674858|NCT01320943|3080803|Superiority|||||||0.022||||||Log-rank test statistic was used to compare the time to HBsAg loss between the two treatment arms.|Log Rank||||
1674859|NCT01320722|3080830|Superiority|||||||0.97|||||||Repeated Measures Analysis||||
1674860|NCT01320722|3080830|Superiority|||||||0.07|||||||Repeated Measures Analysis||||
1674861|NCT01320722|3080830|Superiority|||||||0.98|||||||Repeated Measures Analysis||||
1674862|NCT01320722|3080831|Superiority|||||||0.8|||||||Repeated Measures Analysis|||Asleep SBP|
1674863|NCT01320722|3080831|Superiority|||||||0.55|||||||Repeated Measures Analysis|||Awake SBP|
1674864|NCT01320722|3080831|Superiority|||||||0.53|||||||Repeated Measures Analysis||||
1674865|NCT01320722|3080831|Superiority|||||||0.59|||||||Repeated Measures Analysis|||Overall SBP|
1674866|NCT01320722|3080831|Superiority|||||||0.08|||||||Repeated Measures Analysis|||Asleep SBP|
1674867|NCT01320722|3080831|Superiority|||||||0.57|||||||Repeated Measures Analysis|||Awake SBF|
1674868|NCT01320722|3080831|Superiority|||||||0.59|||||||Repeated Measures Analysi|||Overall DBP|
1674869|NCT01320722|3080831|Superiority|||||||0.34|||||||Repeated Measures Analysis|||Overall SBP|
1674870|NCT01320722|3080831|Superiority|||||||0.97||||||Statistical significance was set for P>0.05.|Repeated Measures Analysis|||Asleep SBP at Week 8|
1674871|NCT01320722|3080831|Superiority|||||||0.8||||||Statistical significance was set for P>0.05.|Repeated Measures Analysis|||Awake SBP|
1674872|NCT01320722|3080831|Superiority|||||||0.64||||||Statistical significance was set for P>0.05.|Repeated Measures Analysis|||Overall DBP|
1674873|NCT01320722|3080831|Superiority|||||||0.92||||||Statistical significance was set for P>0.05.|Repeated Measures Analysis|||Overall SBP|
1674874|NCT01320722|3080832|Superiority|||||||0.06||||||Statistical significance was set for a 2-tailed P <0.05.|t-test, 2 sided|||Week 8|
1674875|NCT01320722|3080832|Superiority|||||||0.7||||||Statistical significance was set for a 2-tailed P <0.05.|t-test, 2 sided|||Week 8|
1674876|NCT01320722|3080832|Superiority or Other|||||||0.35|||||||t-test, 2 sided|Statistical significance was set for a 2-tailed P <0.05.||Week 8|
1674877|NCT01320722|3080833|Superiority|||||||0.1|||||||Repeated Measures Analysis||||
1674878|NCT01320722|3080833|Superiority|||||||0.3|||||||Repeated Measures Analysis||||
1674884|NCT01320722|3080837|Superiority|||||||0.77||||||Statistical significance was set for P>0.05.|t-test, 2 sided|||Week 8|
1674885|NCT01320722|3080838|Superiority|||||||0.72|||||||Repeated Measures Analysis|||Week 8|
1674886|NCT01320293|3080843|Superiority or Other|||||||0.05|||||||t-test, 1 sided|||Null hypothesis: change in adiponectin levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)|
1674887|NCT01320293|3080844|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|||Null hypothesis: change in IL-6 levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)|
1674888|NCT01320293|3080845|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|||Null hypothesis: Percent change in endothelial function from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)|
1674889|NCT01320202|3080860|Superiority or Other||Difference in LS Means between SFP & PBO|3.6|Standard Error of the Mean|1.4||0.011|2-Sided|||||LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum.|ANCOVA||||
1674890|NCT01320033|3080875|Superiority||Mean Difference (Final Values)|-0.7||||0.595|2-Sided|95.0|-3.2|1.8|||ANCOVA||||
1674891|NCT01320033|3080875|Superiority||Mean Difference (Final Values)|-2.9||||0.024|2-Sided|95.0|-5.4|-0.4|||ANCOVA||||
1674892|NCT01320033|3080875|Superiority||Mean Difference (Final Values)|-3.6||||0.006|2-Sided|95.0|-6.1|-1.1|||ANCOVA||||
1674893|NCT01319721|3080964|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1674894|NCT01319721|3080965|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1674895|NCT01319721|3080966|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1674896|NCT01319721|3080967|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1674897|NCT01319721|3080968|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1674898|NCT01318538|3081077|Superiority or Other|||||||0.799|||||||linear mixed effect model|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment by phase interaction. Note: Women in both the WRG and GDC groups had significant (p<0.05) reductions in mean number of drinks per drinking day only during the in treatment phase (2.0 and 2.9 reductions for WRG and GDC, respectively).|
1674899|NCT01318538|3081078|Superiority or Other|||||||0.904|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p<0.0001) reductions in mean number of heavy drinking days during treatment (8.6 and 12.1 days reduction for WRG and GDC, respectively) and at 6 months post-treatment (8.0 and 11.8 day reductions).|
1674900|NCT01318538|3081079|Superiority or Other|||||||0.464|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p<0.05) reductions in mean number of drug use days during treatment (3.0 and 1.5 day reductions for WRG and GDC respectively); however at 6 months post-treatment, the reductions were significant for WRG (2.8 day reduction; p<0.05) but not for GDC (1.5 day reduction; p>0.01).|
1674901|NCT01318538|3081080|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1674902|NCT01318538|3081081|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1674903|NCT01318538|3081083|Superiority or Other|||||||0.667|||||||Linear mixed effect models|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).|
1674904|NCT01318538|3081084|Superiority or Other|||||||0.253|||||||Linear mixed effect models|This measure was analyzed using using linear mixed effect models with estimation via restricted maximum likelihood (absolute changes in the mean).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).|
1674905|NCT01318538|3081085|Superiority or Other|||||||0.519|||||||loglinear (negative binomial) regression|We used loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE).||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p<0.0001 reductions in mean # of alcohol use days during treatment (9.9 and 12.4 day reductions for WRG and GDC respectively) and at 6 months post-treatment (8.3 and 12.2 day reductions).|
1674906|NCT01318538|3081086|Superiority or Other|||||||0.821|||||||loglinear (negative binomial) regression|Analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (relative changes i.e. % change)||The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores. With a total of 100 women, the study was adequately powered to detect a minimum 5 day benefit in the # of days of any substance use (power = 83%).|
1674907|NCT01318408|3081106|Non-Inferiority or Equivalence|Assessing cognitive effects over time.||||||0.02|||||||Wilcoxon (Mann-Whitney)|Lower scores (negative change) indicate improvements on the ADAS-cog.|||
1674959|NCT01318070|3081212|Superiority or Other||Mean Difference (Final Values)|-0.359|||||2-Sided|95.0|-0.432|-0.287|||||||
1674960|NCT01318070|3081212|Superiority or Other||Mean Difference (Final Values)|-0.363|||||2-Sided|95.0|-0.434|-0.292|||||||
1674908|NCT01318408|3081107|Non-Inferiority or Equivalence|Assessing effects on cognition over time.||||||0.01|||||||Wilcoxon (Mann-Whitney)|||The intent-to-treat group included all individuals who initiated levetiracetam. The Mann-Whitney U test was used to determine changes in participants’ scores for cognition, function, and behavior between baseline and 12 weeks.Change in MMSE test scores was the primary outcome measure.|
1674909|NCT01318109|3081187|Superiority or Other||Mean Difference (Final Values)|-6.41|||||2-Sided|95.0|-16.34|3.52|||||||
1674910|NCT01318109|3081187|Superiority or Other||Mean Difference (Final Values)|-8.89|||||2-Sided|95.0|-20.14|2.37|||||||
1674911|NCT01318109|3081188|Superiority or Other||Mean Difference (Final Values)|-22.38|||||2-Sided|95.0|-30.87|-13.88|||||||
1674912|NCT01318109|3081188|Superiority or Other||Mean Difference (Final Values)|-18.24|||||2-Sided|95.0|-26.32|-10.16|||||||
1674913|NCT01318109|3081189|Superiority or Other||Mean Difference (Final Values)|-18.16|||||2-Sided|95.0|-25.43|-10.9|||||||
1674914|NCT01318109|3081189|Superiority or Other||Mean Difference (Final Values)|-18.87|||||2-Sided|95.0|-25.95|-11.79|||||||
1674915|NCT01318109|3081190|Superiority or Other||Mean Difference (Final Values)|-21.35|||||2-Sided|95.0|-28.32|-14.39|||||||
1674916|NCT01318109|3081190|Superiority or Other||Mean Difference (Final Values)|-17.6|||||2-Sided|95.0|-24.54|-10.66|||||||
1674917|NCT01318109|3081191|Superiority or Other||Mean Difference (Final Values)|-23.27|||||2-Sided|95.0|-30.43|-16.12|||||||
1674918|NCT01318109|3081191|Superiority or Other||Mean Difference (Final Values)|-19.26|||||2-Sided|95.0|-26.12|-12.4|||||||
1674919|NCT01318109|3081192|Superiority or Other||Hazard Ratio, log|-0.692|||||2-Sided|95.0|-0.814|-0.569|||||||
1674920|NCT01318109|3081192|Superiority or Other||Mean Difference (Final Values)|-0.621|||||2-Sided|95.0|-0.757|-0.486|||||||
1674921|NCT01318109|3081193|Superiority or Other||Mean Difference (Final Values)|-0.403|||||2-Sided|95.0|-0.484|-0.323|||||||
1674922|NCT01318109|3081193|Superiority or Other||Hazard Ratio, log|-0.386|||||2-Sided|95.0|-0.469|-0.303|||||||
1674923|NCT01318109|3081194|Superiority or Other||Mean Difference (Final Values)|-0.192|||||2-Sided|95.0|-0.242|-0.143|||||||
1674924|NCT01318109|3081194|Superiority or Other||Mean Difference (Final Values)|-0.191|||||2-Sided|95.0|-0.247|-0.135|||||||
1674925|NCT01318109|3081195|Superiority or Other||Mean Difference (Final Values)|-0.858|||||2-Sided|95.0|-1.019|-0.697|||||||
1674926|NCT01318109|3081195|Superiority or Other||Mean Difference (Final Values)|-0.751|||||2-Sided|95.0|-0.923|-0.579|||||||
1674927|NCT01318083|3081196|Superiority or Other||Mean Difference (Final Values)|-19.18|||||2-Sided|95.0|-33.4|-4.95|||||||
1674928|NCT01318083|3081196|Superiority or Other||Mean Difference (Final Values)|-23.41|||||2-Sided|95.0|-36.58|-10.23|||||||
1674929|NCT01318083|3081197|Superiority or Other||Mean Difference (Final Values)|-21.93|||||2-Sided|95.0|-30.33|-13.54|||||||
1674930|NCT01318083|3081197|Superiority or Other||Mean Difference (Final Values)|-28.37|||||2-Sided|95.0|-37.14|-19.59|||||||
1674931|NCT01318083|3081198|Superiority or Other||Mean Difference (Final Values)|-22.72|||||2-Sided|95.0|-30.76|-14.69|||||||
1674932|NCT01318083|3081198|Superiority or Other||Mean Difference (Final Values)|-27.62|||||2-Sided|95.0|-35.32|-19.91|||||||
1674933|NCT01318083|3081199|Superiority or Other||Mean Difference (Final Values)|-24.88|||||2-Sided|95.0|-32.33|-17.43|||||||
1674934|NCT01318083|3081199|Superiority or Other||Mean Difference (Final Values)|-23.17|||||2-Sided|95.0|-30.33|-16.02|||||||
1674935|NCT01318083|3081200|Superiority or Other||Mean Difference (Final Values)|-17.59|||||2-Sided|95.0|-24.93|-10.25|||||||
1674936|NCT01318083|3081200|Superiority or Other||Mean Difference (Final Values)|-17.71|||||2-Sided|95.0|-24.6|-10.83|||||||
1674937|NCT01318083|3081201|Superiority or Other||Mean Difference (Final Values)|-0.77|||||2-Sided|95.0|-0.911|-0.629|||||||
1674938|NCT01318083|3081201|Superiority or Other||Mean Difference (Final Values)|-0.695|||||2-Sided|95.0|-0.834|-0.556|||||||
1674939|NCT01318083|3081202|Superiority or Other||Mean Difference (Final Values)|-0.453|||||2-Sided|95.0|-0.547|-0.358|||||||
1674940|NCT01318083|3081202|Superiority or Other||Mean Difference (Final Values)|-0.41|||||2-Sided|95.0|-0.507|-0.312|||||||
1674941|NCT01318083|3081203|Superiority or Other||Mean Difference (Final Values)|-0.213|||||2-Sided|95.0|-0.273|-0.154|||||||
1674942|NCT01318083|3081203|Superiority or Other||Mean Difference (Final Values)|-0.196|||||2-Sided|95.0|-0.261|-0.131|||||||
1674943|NCT01318083|3081204|Superiority or Other||Mean Difference (Final Values)|-0.998|||||2-Sided|95.0|-1.16|-0.837|||||||
1674944|NCT01318083|3081204|Superiority or Other||Mean Difference (Final Values)|-0.936|||||2-Sided|95.0|-1.097|-0.775|||||||
1674945|NCT01318070|3081205|Superiority or Other||Mean Difference (Final Values)|-0.773|||||2-Sided|95.0|-0.913|-0.634|||||||
1674946|NCT01318070|3081205|Superiority or Other||Median Difference (Final Values)|-0.717|||||2-Sided|95.0|-0.848|-0.586|||||||
1674947|NCT01318070|3081206|Superiority or Other||Mean Difference (Final Values)|-21.19|||||2-Sided|95.0|-30.43|-11.95|||||||
1674948|NCT01318070|3081206|Superiority or Other||Mean Difference (Final Values)|-12.31|||||2-Sided|95.0|-21.51|-3.1|||||||
1674949|NCT01318070|3081207|Superiority or Other||Mean Difference (Final Values)|-16.49|||||2-Sided|95.0|-22.78|-10.19|||||||
1674950|NCT01318070|3081207|Superiority or Other||Mean Difference (Final Values)|-12.46|||||2-Sided|95.0|-18.51|-6.4|||||||
1674951|NCT01318070|3081208|Superiority or Other||Mean Difference (Final Values)|-17.08|||||2-Sided|95.0|-22.64|-11.53|||||||
1674952|NCT01318070|3081208|Superiority or Other||Mean Difference (Final Values)|-12.88|||||2-Sided|95.0|-18.09|-7.68|||||||
1674953|NCT01318070|3081209|Superiority or Other||Mean Difference (Final Values)|-14.82|||||2-Sided|95.0|-20.0|-9.63|||||||
1674954|NCT01318070|3081209|Superiority or Other||Mean Difference (Final Values)|-11.24|||||2-Sided|95.0|-16.22|-6.25|||||||
1674955|NCT01318070|3081210|Superiority or Other||Mean Difference (Final Values)|-13.06|||||2-Sided|95.0|-17.86|-8.26|||||||
1674956|NCT01318070|3081210|Superiority or Other||Mean Difference (Final Values)|-8.83|||||2-Sided|95.0|-13.2|-4.47|||||||
1674957|NCT01318070|3081211|Superiority or Other||Mean Difference (Final Values)|-0.635|||||2-Sided|95.0|-0.743|-0.526|||||||
1674958|NCT01318070|3081211|Superiority or Other||Mean Difference (Final Values)|-0.588|||||2-Sided|95.0|-0.692|-0.484|||||||
1674961|NCT01318070|3081213|Superiority or Other||Mean Difference (Final Values)|-0.18|||||2-Sided|95.0|-0.225|-0.135|||||||
1674962|NCT01318070|3081213|Superiority or Other||Mean Difference (Final Values)|-0.179|||||2-Sided|95.0|-0.224|-0.135|||||||
1674963|NCT01317160|3081271|Superiority or Other (legacy)|||||||0.737|||||||Chi-squared||||
1674964|NCT01317160|3081273|Superiority or Other (legacy)||Odds Ratio (OR)|2.81|||<|0.05|2-Sided|95.0|1.25|6.32|||Regression, Logistic|Age was adjusted for in the calculation.|Risk of VTE by routine care (numerator) divided by IPC treatment (denominator)||
1674965|NCT01317160|3081273|Superiority or Other (legacy)||||||<|0.042|||||||Chi-squared|||Domeij-Arverud et al., Bone Joint J 2015;97-B:675–80.|
1674966|NCT01316939|3081309|Superiority or Other||Percent difference of participants|-5.3|||||2-Sided|95.0|-13.1|2.6|||||||
1674967|NCT01316939|3081309|Superiority or Other||Percent difference of participants|-4.0|||||2-Sided|95.0|-12.2|4.2||||||Placebo Vs GSK1605786A 500 mg once daily at Week 28 and 52|
1674968|NCT01316939|3081310|Superiority or Other||Percent difference of participants|-6.6|||||2-Sided|95.0|-14.8|1.6||||||Placebo Vs GSK1605786A 500 mg BID at Week 28 and 52|
1674969|NCT01316939|3081310|Superiority or Other||Percent difference of participants|-4.0|||||2-Sided|95.0|-12.9|4.8||||||Placebo Vs GSK1605786A 500 mg once daily at Week 28 and 52|
1674970|NCT01316926|3081311|Non-Inferiority or Equivalence|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency – ANVISA – upon manufacturing a site change.|Ratio T formulation/R formulation|0.9333|||||2-Sided|90.0|0.8502|1.0246|||||Coefficient Variation (intra-individual). The ratios between the geometric means of the test and reference formulations was calculated.||
1674971|NCT01316926|3081312|Non-Inferiority or Equivalence|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency – ANVISA – upon manufacturing a site change.|Ratio T formulation/R formulation|0.941|||||2-Sided|90.0|0.846|1.0467|||||Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.||
1674972|NCT01316926|3081313|Non-Inferiority or Equivalence|This is a bioequivalence study. The study was performed to fulfill an official requirement of the Brazilian Regulatory Agency – ANVISA – upon manufacturing a site change.|Ratio T formulation/R formulation|0.9204|||||2-Sided|90.0|0.8556|0.99|||||Coefficient Variation (intra-individual). The ratio between the geometric means of the test and reference formulations was calculated.||
1674973|NCT01316913|3081316|Superiority or Other||Least squares mean difference|0.074||||0.003|2-Sided|95.0|0.025|0.123|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus TIO 18 µg.||
1674974|NCT01316913|3081316|Superiority or Other||Least squares mean difference|0.037||||0.142|2-Sided|95.0|-0.012|0.087|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus UMEC 125 µg.||
1674975|NCT01316913|3081316|Superiority or Other||Least squares mean difference|0.06||||0.018|2-Sided|95.0|0.01|0.109||nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus TIO 18 µg.||
1674976|NCT01316913|3081316|Superiority or Other||Least squares mean difference|0.022||||0.377|2-Sided|95.0|-0.027|0.072|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus UMEC 125 µg.||
1674977|NCT01316900|3081319|Superiority or Other||Least squares mean difference|0.088|||<|0.001|2-Sided|95.0|0.036|0.14|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus TIO 18 µg.||
1674978|NCT01316900|3081319|Superiority or Other||Least squares mean difference|0.088|||<|0.001|2-Sided|95.0|0.036|0.14|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus VI 25 µg.||
1674979|NCT01316900|3081319|Superiority or Other||Least squares mean difference|0.09|||<|0.001|2-Sided|95.0|0.039|0.141||nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Tio 18 µg.||
1674980|NCT01316900|3081319|Superiority or Other||Least squares mean difference|0.09|||<|0.001|2-Sided|95.0|0.039|0.142|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus VI 25 µg.||
1674981|NCT01316770|3081361|Other|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."|
1674982|NCT01316770|3081361|Other|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."|
1674983|NCT01316770|3081361|Other|||||||0.625|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."|
1674984|NCT01316770|3081361|Other|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."|
1674985|NCT01316770|3081362|Other|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."|
1674986|NCT01316770|3081362|Other|||||||1|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."|
1674987|NCT01316770|3081362|Other|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."|
1674988|NCT01316770|3081362|Other|||||||0.25|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."|
1674989|NCT01316770|3081365|Other|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."|
1674990|NCT01316770|3081365|Other|||||||1|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."|
1674991|NCT01316770|3081365|Other|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."|
1674992|NCT01316770|3081365|Other|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."|
1674993|NCT01316770|3081366|Other|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."|
1674994|NCT01316770|3081366|Other|||||||1|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."|
1674995|NCT01316770|3081368|Other|||||||1|||||||McNemar|||"McNemar's test on the study Day 56 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 56 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 56.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 56 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 56."|
1674996|NCT01316770|3081368|Other|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 42 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 42 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 42.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 42 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 42."|
1674997|NCT01316770|3081368|Other|||||||1|||||||McNemar|||"McNemar's test on the study Day 28 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 28 is equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 28 is not equal to the probability of subjects shifting their answer from no at Screening to yes at Study Day 28."|
1674998|NCT01316770|3081368|Other|||||||0.5|||||||McNemar|||"McNemar's test on the study Day 14 shift table. The null hypothesis assumes the probability of subjects shifting from yes at Screening to no at Study Day 14 are equal to the probability of subjects shifting from no at Screening to yes at Study Day 14.~Alternative hypothesis is that probability of subjects shifting from yes at Screening to no at Study Day 14 is not equal to the probability of subjects shifting from no at Screening to yes at Study Day 14."|
1674999|NCT01316770|3081382|Superiority|||||||0.586|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.|
1675000|NCT01316770|3081383|Superiority|||||||0.607|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.|
1675001|NCT01316770|3081384|Superiority|||||||0.662|||||||one-sided paired t-test|||The mixed models analysis (including all time points: study days 14, 28, 42, 56) failed to converge; thus, an alternative analysis, as stated in the Statistical Analysis Plan, was performed using the paired t-test. The Satterthwaite correction (Statistical Analysis Plan) is not available for the paired t-test and was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates since this statistical model achieved the best fit to the data.|
1675002|NCT01316770|3081385|Superiority|The standard deviation (SD) of the change in salivary flow was assumed to be 0.0168 for the placebo and 0.0906 for the dexamethasone parotid. The within-subject correlation between two glands was assumed to be 0.15. A total of 16 patients would be required to have 80% power to detect a one-sided 40% increase in dexamethasone-irrigated parotid glands compared with the saline irrigated parotid glands with respect to change in salivary flow from Day 0 to Day 56.||||||0.236||||||No corrections were made for multiple comparisons because there was only one primary hypothesis.|one-sided Paired t-test|||The mixed models analysis included all time points but it failed to converge. Therefore, an alternative analysis was performed using a paired t-test. Because the Satterthwaite correction [that was specified in the statistical analysis plan (SAP) for the mixed model] is not available for the paired t-test, it was not performed on the paired t-test. The final analysis was based upon the raw non-transformed saliva flow rates, as these measures were appropriate for the model used.|
1675003|NCT01316510|3081402|Superiority or Other|||||||0.44|||||||t-test, 2 sided|||Secondary outcome (length of hospital stay) for all 24 infants (this included two infants with intestinal atresia, both in the placebo group)|
1675004|NCT01316510|3081403|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|||Primary outcome (percentage of bifidobacteria in the final stool specimen)|
1675005|NCT01316419|3081408|Superiority or Other|||||||0.0006||||||Mean total cholesterol change from baseline at the last visit will be analyzed by paired t-test|Paired t-test||||
1675006|NCT01316419|3081409|Superiority or Other|||||||0.5579||||||Mean Triglyceride change from baseline at the last visit will be analyzed by paired t-test|Paired t test||||
1675007|NCT01316419|3081410|Superiority or Other|||||||0.4248||||||Mean HDL-C change from baseline at the last visit will be analyzed by paired t-test|Paired t test||||
1675008|NCT01316419|3081411|Superiority or Other|||||||0.0006||||||Mean LDL-C change from baseline at the last visit will be analyzed by paired t-test|Paired t test||||
1675009|NCT01316419|3081413|Superiority or Other||||||<|0.0001||||||The change of QOL data collected using the EQ VAS is analyzed by paired t-test|Paired t test||||
1675010|NCT01316419|3081414|Superiority or Other|||||||0.0013||||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test||||
1675011|NCT01316419|3081415|Superiority or Other|||||||0.0152||||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test||||
1675012|NCT01316419|3081416|Superiority or Other|||||||0.4543||||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test||||
1675013|NCT01316419|3081417|Superiority or Other|||||||0.0197||||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test||||
1675014|NCT01316419|3081418|Superiority or Other|||||||0.1099||||||The change of QOL data collected using the WHOQOL-BREF is analyzed by paired t-test|Paired t test||||
1675015|NCT01316419|3081420|Superiority or Other||||||<|0.0001||||||Mean DBP change from baseline at the last visit will be analyzed by paired t-test|Paired t test||||
1675016|NCT01316419|3081423|Superiority or Other||||||<|0.0001||||||Mean SBP change from baseline at the last visit will be analyzed by paired t-test|Paired t test||||
1675017|NCT01316380|3081424|Superiority or Other||Mean Difference (Net)|-0.01|Standard Error of the Mean|0.068||0.8795|2-Sided|95.0|-0.144|0.123||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment*week and baseline*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.|
1675018|NCT01316380|3081424|Superiority or Other||Mean Difference (Net)|0.131|Standard Error of the Mean|0.068||0.0559|2-Sided|95.0|-0.003|0.265||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment*week and baseline*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.|
1675019|NCT01316380|3081425|Superiority or Other||Mean Difference (Net)|-0.009|Standard Error of the Mean|0.076||0.9104|2-Sided|95.0|-0.158|0.141||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment*week and baseline*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.|
1675020|NCT01316380|3081425|Superiority or Other||Mean Difference (Net)|0.097|Standard Error of the Mean|0.076||0.2038|2-Sided|95.0|-0.053|0.247||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment*week and baseline*week.|Restricted maximum likelihood (REML)- based repeated measures model was used. Means are adjusted for treatment, centre, week, baseline, treatment*week and baseline*week.|
1675021|NCT01316380|3081426|Superiority or Other||Mean Difference (Net)|-0.033|Standard Error of the Mean|0.129||0.7995|2-Sided|95.0|-0.287|0.221||p-values serve an exploratory function only|Mixed Models Analysis||Tio R5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment*week and baseline*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.|
1675022|NCT01316380|3081426|Superiority or Other||Mean Difference (Net)|0.222|Standard Error of the Mean|0.129||0.0872|2-Sided|95.0|-0.032|0.476||p-values serve an exploratory function only|Mixed Models Analysis||Tio R2.5 - Placebo. Means are adjusted for treatment, centre, week, baseline, treatment*week and baseline*week.|Restricted maximum likelihood (REML)- based repeated measures model was used.|
1675023|NCT01316380|3081427|Superiority or Other||Hazard Ratio (HR)|0.96||||0.8974||95.0|0.53|1.75||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since only 22 of the 155 patients in the placebo group, 21 of the 154 patients in the Tio R2.5 group and 13 of the 155 patients in the Tio R5 group had asthma exacerbations, the median times were not calculable (nc). The Hazard Ratio is still estimable from the Cox model.|
1675024|NCT01316380|3081427|Superiority or Other||Hazard Ratio (HR)|0.58||||0.1217||95.0|0.29|1.16||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since only 22 of the 155 patients in the placebo group, 21 of the 154 patients in the Tio R2.5 group and 13 of the 155 patients in the Tio R5 group had asthma exacerbations, the median times were not calculable (nc).|
1675025|NCT01316380|3081428|Superiority or Other||Hazard Ratio (HR)|1.53||||0.5071||95.0|0.43|5.44||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since the percent patients with event is less than 50% the median is not calculable, but Hazard Ratio is still estimable from the Cox model.|
1675026|NCT01316380|3081428|Superiority or Other||Hazard Ratio (HR)|0.25||||0.2155||95.0|0.03|2.24||Significance level of alpha=0.05 (two-sided). P-values serve an exploratory function only.|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.|Since the percent patients with event is less than 50% the median is not calculable, but Hazard Ratio is still estimable from the Cox model.|
1675027|NCT01316380|3081430|Superiority or Other||Mean Difference (Final Values)|0.101|Standard Error of the Mean|0.039||0.0102||95.0|0.024|0.178||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.||
1675028|NCT01316380|3081430|Superiority or Other||Mean Difference (Final Values)|0.061|Standard Error of the Mean|0.039||0.1182||95.0|-0.016|0.138||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.||
1675029|NCT01316380|3081431|Superiority or Other||Mean Difference (Final Values)|0.149|Standard Error of the Mean|0.034|<|0.0001||95.0|0.082|0.216||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.||
1675030|NCT01316380|3081431|Superiority or Other||Mean Difference (Final Values)|0.125|Standard Error of the Mean|0.034|<|0.0003||95.0|0.058|0.192||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.||
1675031|NCT01316380|3081432|Superiority or Other||Mean Difference (Final Values)|0.106|Standard Error of the Mean|0.042||0.0119||95.0|0.023|0.188||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.||
1675032|NCT01316380|3081432|Superiority or Other||Mean Difference (Final Values)|0.057|Standard Error of the Mean|0.042||0.1714||95.0|-0.025|0.14||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.||
1675033|NCT01316380|3081433|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.037||0.0028||95.0|0.038|0.182||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.||
1675034|NCT01316380|3081433|Superiority or Other||Mean Difference (Final Values)|0.122|Standard Error of the Mean|0.037||0.001||95.0|0.049|0.194||p-values serve an exploratory function only|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.||
1675035|NCT01316380|3081434|Superiority or Other||Mean Difference (Final Values)|0.159|Standard Error of the Mean|0.036|<|0.0001||95.0|0.088|0.23||Step-wise testing for the two treatment groups for the primary endpoint, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.025 (one-sided) for the primary endpoint.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R2.5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.||
1675036|NCT01316380|3081434|Superiority or Other||Mean Difference (Final Values)|0.128|Standard Error of the Mean|0.036|<|0.0005||95.0|0.057|0.199||Step-wise testing for the two treatment groups for the primary endpoint, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.025 (one-sided) for primary endpoint.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.||
1675037|NCT01315678|3081528|Superiority||Cox Proportional Hazard|0.84||||0.4861|2-Sided|95.0|0.49|1.44|||Regression, Cox||||
1675038|NCT01315678|3081529|Superiority||Cox Proportional Hazard|1.12||||0.6031|2-Sided|95.0|0.76|1.66|||Regression, Cox||||
1675039|NCT01315678|3081530|Superiority||Cox Proportional Hazard|1.51||||0.0286|2-Sided|95.0|1.07|2.13|||Regression, Cox|||Stratified Cox proportional hazards model|
1675142|NCT01313858|3081718|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)|
1675040|NCT01315353|3081543|Other|||||||1||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.|
1675041|NCT01315353|3081544|Other|||||||0.227||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.|
1675042|NCT01315353|3081545|Other|||||||0.132||||||"P-value for the week 26 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with hr-HPV at week 26.|
1675043|NCT01315353|3081546|Other|||||||0.444||||||"P-value for the week 130 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 130.|
1675044|NCT01315353|3081546|Other|||||||0.375||||||"P-value for the week 104 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 104.|
1675045|NCT01315353|3081546|Other|||||||0.781||||||"P-value for the week 78 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 78.|
1675046|NCT01315353|3081546|Other|||||||0.279||||||"P-value for the week 52 comparison.~The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05."|Fisher Exact|||Null Hypothesis: There is no difference between the Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 52.|
1675047|NCT01315353|3081546|Other|||||||1||||||P-value for the week 26 comparison. The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Fisher Exact|||Null Hypothesis: There is no difference between Arm A and Arm B with respect to the proportion of participants with abnormal cervical cytology results at week 26.|
1675048|NCT01315353|3081547|Other|||||||0.445||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Fisher Exact|||Null hypothesis: There is no difference between Arm A and Arm B with respect to rate of premature study discontinuation.|
1675049|NCT01315353|3081548|Other||Cumulative rate difference|4.4|||||2-Sided|95.0|-4.8|13.6|||||Confidence interval estimation was stratified by ART use at screening using Greenwood’s variance with the inverse of this variance used for the stratum weights.|Treatment comparison was made using the difference (arm B - arm A) in the stratified Kaplan-Meier estimate for the week 130 cumulative rate of CIN3+ with 95% two-sided confidence interval.|
1675050|NCT01315353|3081549|Other|||||||0.94||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Log Rank|Log-rank test was stratified by ART use at screening.||Null Hypothesis: There is no difference between Arm A and Arm B with respect to time to CIN2+.|
1675051|NCT01315353|3081550|Superiority|Confidence interval estimation was stratified by ART use at screening using Greenwood's variance with the inverse of this variance used for the stratum weights.|Cumulative rate difference|1.7|||||1-Sided|95.0|-7.9||||||The lower bound of the (lower) one-sided 95% confidence interval was provided.|Treatment comparison was made using the difference (arm B - arm A) in the stratified Kaplan-Meier estimate for the week 130 cumulative rate of CIN2+ with 95% one-sided confidence interval.|
1675052|NCT01315236|3081563|Superiority||Cox Proportional Hazard|2.69||||0.0076|2-Sided|95.0|1.28|5.64|||Regression, Cox|||Cox Proportional Hazard Model|
1675053|NCT01315236|3081565|Superiority|||||||0.4545|||||||Wilcoxon (Mann-Whitney)|||Stratified Wilcoxon-rank sum|
1675054|NCT01315236|3081566|Superiority|||||||0.077|||||||Regression, Logistic|||Ordinal Logistic Regressions Model|
1675055|NCT01315236|3081567|Superiority||Cox Proportional Hazard|5.68||||0.0129|2-Sided|95.0|1.25|25.79|||Regression, Cox|||Cox proportional hazard model|
1675056|NCT01315236|3081568|Superiority|||||||0.003|||||||Cochran-Mantel-Haenszel|||stratified Cochran-Mantel-Haenszel test|
1675057|NCT01315236|3081569|Superiority|||||||0.072||||||Conducted in the mITT population using a stratified Wilcoxon rank sum test, to compare the treatment arms at a 2-sided significance level of 0.05, adjusting for the randomization strata (presence/absence of CF and MAC versus Mycobacterium abscessus).|Wilcoxon rank sum test|||"The primary efficacy analysis tested the following hypotheses:~H0: There is no difference at Day 84 between the LAI arm and the placebo arm~Ha: There is a difference at Day 84 between the LAI arm and the placebo arm~Statistical analysis applies to all day 84 rows."|
1675058|NCT01315028|3081582|Superiority or Other||||||<|0.05|||||||ANOVA||||
1675059|NCT01315028|3081583|Superiority or Other||||||<|0.05|||||||ANOVA||||
1675060|NCT01315028|3081584|Superiority or Other|||||||0.996|||||||ANOVA|||Parametric and non-parametric descriptive data were summarised and presented. All data analyses were based on the Intention to Treat (ITT) principle. For the main analysis, Repeated Measures Analysis of Variance was performed to identify signals suggesting treatment effects on the outcome measures. Effect sizes were also calculated in order to further examine suggestive trends in the data indicating appropriate outcomes for further research.|
1675061|NCT01315028|3081585|Superiority or Other|||||||0.05|||||||ANOVA||||
1675092|NCT01314872|3081611|Superiority or Other||Difference in LS Means|-0.18||||0.401|2-Sided|95.0|-0.61|0.25|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675543|NCT01309282|3082386|Superiority or Other|||||||0.0225|||||||Wilcoxon signed rank test||||
1675062|NCT01315002|3081586|Superiority or Other||||||<|0.05|||||||ANOVA|||Null hypothesis is that there was no difference in change of error percentage in the antisaccade task between nicotine and placebo. An ANOVA model was used with treatment (nicotine, placebo) as a within-subjects factor. The test was performed with a significance level of 0.05 (two-sided). Results showed significantly better antisaccade performance (i.e. less antisaccade errors) in the nicotine condition.|
1675063|NCT01314911|3081588|Superiority|||||||0.022||||||P-value was not adjusted for multiple interim analyses.|Wilcoxon (Mann-Whitney)||||
1675064|NCT01314911|3081591|Superiority||Mean Difference (Final Values)|-13.6||||0.0021|2-Sided|95.0|-22.2|-5.1||P-value was not adjusted for multiple interim analyses.|Z test||||The difference in percents was calculated as the percent with detectable in the Oseltamivir arm minus the percent with detectable in the placebo arm.
1675065|NCT01314911|3081593|Superiority||Mean Difference (Final Values)|0.4||||0.8498|2-Sided|95.0|-3.8|4.7||P-value was not adjusted for multiple interim analyses.|Z test||The difference in percents was calculated as the percent in the Oseltamivir arm minus the percent in the placebo arm.|This test compared the difference in percentages of participants with at least one complication between two randomized arms.|
1675066|NCT01314911|3081594|Superiority||Mean Difference (Final Values)|0.7||||0.5311|2-Sided|95.0|-1.4|3.0||P-value was not adjusted for multiple interim analyses.|two-sample binomial exact test|The two-sample binomial exact test was performed in PROC STATXACT.|The difference in percents was calculated as the percent in the Oseltamivir arm minus the percent in the placebo arm.||
1675067|NCT01314911|3081596|Superiority|||||||0.5466||||||P-value was not adjusted for multiple interim analyses.|Log Rank||||
1675068|NCT01314911|3081597|Superiority|||||||0.3025||||||P-value was not adjusted for multiple interim analyses.|Log Rank||||
1675069|NCT01314911|3081598|Superiority|||||||0.1501||||||P-value was not adjusted for multiple interim analyses.|Log Rank||||
1675070|NCT01314911|3081599|Superiority|||||||0.7461||||||P-value was not adjusted for multiple interim analyses.|Log Rank||||
1675071|NCT01314911|3081600|Superiority|||||||0.88||||||P-value was not adjusted for multiple interim analyses.|Log Rank||||
1675072|NCT01314911|3081601|Superiority|||||||0.41||||||P-value was not adjusted for multiple interim analyses.|Log Rank||||
1675073|NCT01314911|3081602|Superiority|||||||0.0243||||||P-value was not adjusted for multiple interim analyses.|Wilcoxon (Mann-Whitney)||||
1675074|NCT01314911|3081605|Superiority||Mean Difference (Final Values)|-12.2|Standard Error of the Mean|4.6||0.0097|2-Sided|95.0|-21.4|-3.0||P-value was not adjusted for multiple interim analyses.|Z-test, 2-sided|Comparison of randomized arms was based on the normal approximation to the binomial distribution.|The difference in percents was calculated as the percent detectable in the Oseltamivir arm minus the percent detectable in the Placebo arm.|Assuming that pooled percentage of participants with virus detectable by PCR at Day 3 is 50%, assuming that the Oseltamivir arm was better than the placebo arm and that the detectable rate in the Oseltamivir arm was 42.5% compared to 57.5% in the placebo arm (a 15% reduction), and assuming 10% subjects with missing qPCR at Day 3, in a two-sided, two-sample 0.05-level t- test with 546 participants combined across both arms, there was 90% power.|
1675075|NCT01314872|3081606|Superiority or Other||Difference in LS means|-1.24|||||2-Sided|95.0|-1.93|-0.56|||||||
1675076|NCT01314872|3081606|Superiority or Other||Difference in LS means|-0.76|||||2-Sided|95.0|-1.45|-0.08|||||||
1675077|NCT01314872|3081607|Superiority or Other||Difference in LS means|0.02|||||2-Sided|95.0|-0.48|0.51|||||||
1675078|NCT01314872|3081607|Superiority or Other||Difference in LS means|-0.07|||||2-Sided|95.0|-0.56|0.43|||||||
1675079|NCT01314872|3081608|Superiority or Other||Difference in LS means|-0.21|||||2-Sided|95.0|-0.64|0.21|||||||
1675080|NCT01314872|3081608|Superiority or Other||Difference in LS means|-0.29|||||2-Sided|95.0|-0.71|0.13|||||||
1675081|NCT01314872|3081609|Superiority or Other||Difference in LS means|-1.1|||||2-Sided|95.0|-1.62|-0.58|||||||
1675082|NCT01314872|3081609|Superiority or Other||Difference in LS means|-0.49|||||2-Sided|95.0|-1.0|0.03|||||||
1675083|NCT01314872|3081610|Superiority or Other||Difference in LS means|-0.94||||0.007|2-Sided|95.0|-1.62|-0.26|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675084|NCT01314872|3081610|Superiority or Other||Difference in LS means|-1.24|||<|0.001|2-Sided|95.0|-1.9|-0.58|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675085|NCT01314872|3081610|Superiority or Other||Difference in LS means|-0.76|||<|0.024|2-Sided|95.0|-1.43|-0.1|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675086|NCT01314872|3081610|Superiority or Other||Difference in LS means|-0.67|||<|0.052|2-Sided|95.0|-1.35|0.01|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675087|NCT01314872|3081610|Superiority or Other||Difference in LS means|-0.18|||<|0.598|2-Sided|95.0|-0.84|0.49|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675088|NCT01314872|3081611|Superiority or Other||Difference in LS Means|-0.34||||0.14|2-Sided|95.0|-0.78|0.11|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675089|NCT01314872|3081611|Superiority or Other||Difference in LS Means|-0.58||||0.007|2-Sided|95.0|-1.01|-0.16|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675090|NCT01314872|3081611|Superiority or Other||Difference in LS Means|-0.6||||0.005|2-Sided|95.0|-1.02|-0.18|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675091|NCT01314872|3081611|Superiority or Other||Difference in LS Means|-0.48||||0.029|2-Sided|95.0|-0.91|-0.05|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675141|NCT01313858|3081718|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)|
1675093|NCT01314872|3081612|Superiority or Other||Difference in LS means|-0.46||||0.03|2-Sided|95.0|-0.87|-0.04|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675094|NCT01314872|3081612|Superiority or Other||Difference in LS means|-0.71|||<|0.001|2-Sided|95.0|-1.1|-0.32|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675095|NCT01314872|3081612|Superiority or Other||Difference in LS means|-0.72|||<|0.001|2-Sided|95.0|-1.11|-0.33|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675096|NCT01314872|3081612|Superiority or Other||Difference in LS means|-0.57|||<|0.005|2-Sided|95.0|-0.97|-0.17|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675097|NCT01314872|3081612|Superiority or Other||Difference in LS means|-0.28|||<|0.167|2-Sided|95.0|-0.68|0.12|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, and interaction of time by treatment.|||
1675098|NCT01314872|3081617|Superiority or Other||Difference in LS means|-0.54||||0.026|2-Sided|95.0|-1.02|-0.07|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.|||
1675099|NCT01314872|3081617|Superiority or Other||Difference in LS means|-0.91|||<|0.001|2-Sided|95.0|-1.37|-0.44|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.|||
1675100|NCT01314872|3081617|Superiority or Other||Difference in LS means|-0.64|||<|0.007|2-Sided|95.0|-1.11|-0.18|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.|||
1675101|NCT01314872|3081617|Superiority or Other||Difference in LS means|-0.45|||<|0.064|2-Sided|95.0|-0.93|0.03|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.|||
1675102|NCT01314872|3081617|Superiority or Other||Difference in least squares (LS) means|-0.46|||<|0.056|2-Sided|95.0|-0.92|0.01|||Constrained Longitudinal Data Analysis|Constrained longitudinal data analysis model includes terms for time, region, part and interaction of time by treatment.|||
1675103|NCT01314716|3081621|Superiority or Other||Difference in least squares mean|1.1||||0.56|2-Sided|95.0|-2.7|5.0||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM||||
1675104|NCT01314716|3081622|Superiority or Other||Differences in least squares mean|4.6||||0.011|2-Sided|95.0|1.1|8.2||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM||||
1675105|NCT01314703|3081623|Superiority or Other||Mean Difference (Net)|3.53|Standard Error of the Mean|0.149|||2-Sided|95.0|3.24|3.82|||||70% Isopropyl Alcohol 10 minute groin|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).|
1675106|NCT01314703|3081623|Superiority or Other||Mean Difference (Net)|2.53|Standard Error of the Mean|0.089|||2-Sided|95.0|2.36|2.7|||||70%Isopropyl Alcohol 10 minute abdomen|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).|
1675107|NCT01314703|3081623|Superiority or Other||Mean Difference (Net)|4.038|Standard Error of the Mean|0.149|||2-Sided|95.0|3.74|4.33|||||ChloraPrep 10 minute groin|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).|
1675108|NCT01314703|3081623|Superiority or Other||Mean Difference (Net)|2.85|Standard Error of the Mean|0.089|||2-Sided|95.0|2.66|3.02|||||ChloraPrep 10 minute abdomen|Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).|
1675109|NCT01314261|3081659|Superiority or Other|||||||0.021||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.|||
1675110|NCT01314261|3081659|Superiority or Other|||||||0.051||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.|||
1675111|NCT01314261|3081659|Superiority or Other|||||||0.028||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.|||
1675112|NCT01314261|3081662|Superiority or Other|||||||0.105||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank||||
1675113|NCT01314261|3081662|Superiority or Other|||||||0.029||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank||||
1675114|NCT01314261|3081662|Superiority or Other|||||||0.007||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Log Rank||||
1675115|NCT01314261|3081663|Superiority or Other|||||||0.166||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.|||
1675544|NCT01309282|3082387|Superiority or Other|||||||0.5469|||||||Wilcoxon signed rank test||||
1675116|NCT01314261|3081663|Superiority or Other|||||||0.328||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.|||
1675117|NCT01314261|3081663|Superiority or Other|||||||0.127||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.|||
1675118|NCT01314261|3081664|Superiority or Other|||||||0.231||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.|||
1675119|NCT01314261|3081664|Superiority or Other|||||||0.214||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.|||
1675120|NCT01314261|3081664|Superiority or Other|||||||0.155||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.|||
1675121|NCT01314261|3081665|Superiority or Other|||||||0.221||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or > median).|||
1675122|NCT01314261|3081665|Superiority or Other|||||||0.515||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or > median).|||
1675123|NCT01314261|3081665|Superiority or Other|||||||0.083||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or > median).|||
1675124|NCT01314261|3081669|Superiority or Other|||||||0.079||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or > median).|||
1675125|NCT01314261|3081669|Superiority or Other|||||||0.362||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or > median).|||
1675126|NCT01314261|3081669|Superiority or Other|||||||0.102||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Cochran-Mantel-Haenszel|Controlled for interleukin 28B genotype (CC or non-CC), HCV sub-genotype (1a or 1b), and baseline HCV RNA levels (≤ median or > median).|||
1675127|NCT01314261|3081670|Superiority or Other|||||||0.03||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.|
1675128|NCT01314261|3081670|Superiority or Other|||||||0.171||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV sub-genotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.|
1675129|NCT01314261|3081670|Superiority or Other|||||||0.336||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Regression, Logistic|Treatment group, baseline HCV RNA level, HCV subgenotype (1a or 1b), and interleukin 28B genotype (CC or non-CC) were predictors.||Ten participants in an ABT-267 arm and nine participants in the placebo arm would provide 84% power using Fisher's exact test with two-sided significance level of 0.05 to detect a difference of approximately 70% between the two arms.|
1675130|NCT01313910|3081708|Superiority or Other|||||||0.016|||||||Wilcoxon (Mann-Whitney)||||
1675131|NCT01313910|3081710|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1675132|NCT01313910|3081711|Superiority or Other|||||||0.11|||||||Wilcoxon (Mann-Whitney)||||
1675133|NCT01313910|3081712|Superiority or Other|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Wilcoxin-rank test used to determine decrease in bowel movements/day after 8 weeks of intervention|
1675134|NCT01313858|3081718|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)|
1675135|NCT01313858|3081718|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)|
1675136|NCT01313858|3081718|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)|
1675137|NCT01313858|3081718|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)|
1675138|NCT01313858|3081718|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)|
1675139|NCT01313858|3081718|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)|
1675140|NCT01313858|3081718|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)|
1675143|NCT01313858|3081718|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)|
1675144|NCT01313858|3081718|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)|
1675145|NCT01313858|3081718|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)|
1675146|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)|
1675147|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)|
1675148|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)|
1675149|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)|
1675150|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)|
1675151|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)|
1675152|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)|
1675153|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)|
1675154|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)|
1675155|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)|
1675156|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)|
1675157|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)|
1675158|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)|
1675159|NCT01313858|3081719|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)|
1675160|NCT01313858|3081719|Superiority or Other||||||<|0.0003|||||||Repeated measures analysis|||Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)|
1675161|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)|
1675162|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)|
1675163|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)|
1675164|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)|
1675165|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)|
1675166|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)|
1675167|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)|
1675168|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)|
1675169|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)|
1675170|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)|
1675171|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)|
1675172|NCT01313858|3081720|Superiority or Other||||||<|0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)|
1675173|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)|
1675174|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)|
1675175|NCT01313858|3081720|Superiority or Other||||||<|0.0001|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)|
1675176|NCT01313858|3081720|Superiority or Other||||||<|0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)|
1675177|NCT01313858|3081720|Superiority or Other||||||<|0.0002|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)|
1675178|NCT01313858|3081720|Superiority or Other||||||<|0.0059|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)|
1675179|NCT01313858|3081720|Superiority or Other||||||<|0.0004|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)|
1675180|NCT01313858|3081720|Superiority or Other||||||<|0.0029|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)|
1675181|NCT01313858|3081720|Superiority or Other||||||<|0.0015|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)|
1675182|NCT01313858|3081720|Superiority or Other||||||<|0.0011|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)|
1675183|NCT01313858|3081720|Superiority or Other||||||<|0.0007|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)|
1675184|NCT01313858|3081720|Superiority or Other||||||<|0.0007|||||||Repeated measures analysis|||Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)|
1675185|NCT01313767|3081724|Superiority or Other||Mean Difference (Final Values)|-0.27||||0.284|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.|
1675186|NCT01313767|3081724|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.8884|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.|
1675187|NCT01313767|3081724|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.7014|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.|
1675188|NCT01313767|3081725|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.5436|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.|
1675189|NCT01313767|3081725|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.7998|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.|
1675190|NCT01313767|3081725|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.9362|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.|
1675191|NCT01313767|3081726|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.7715|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.|
1675192|NCT01313767|3081726|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.7302|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.|
1675193|NCT01313767|3081726|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.9634|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.|
1675194|NCT01313767|3081727|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.1497|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.|
1675195|NCT01313767|3081727|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.3702|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.|
1675196|NCT01313767|3081727|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.8088|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.|
1675197|NCT01313767|3081728|Superiority or Other|||||||0.9513|||||||Fisher Exact|||Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.|
1675198|NCT01313767|3081729|Superiority or Other|||||||0.2346|||||||Fisher Exact|||Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.|
1675199|NCT01313767|3081730|Superiority or Other||Mean Difference (Final Values)|0.5||||0.4017|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of pain was compared using wilcoxon rank sum test.|
1675200|NCT01313767|3081730|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.7237|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of pain was compared using wilcoxon rank sum test.|
1675201|NCT01313767|3081730|Superiority or Other||Mean Difference (Final Values)|0.25||||0.7237|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of pain was compared using wilcoxon rank sum test.|
1675202|NCT01313767|3081731|Superiority or Other||Mean Difference (Final Values)|0.01||||0.9574|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of limb position was compared using wilcoxon rank sum test.|
1675203|NCT01313767|3081731|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.6934|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of limb position was compared using wilcoxon rank sum test.|
1675204|NCT01313767|3081731|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.503|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of limb position was compared using wilcoxon rank sum test.|
1675205|NCT01313767|3081732|Superiority or Other||Mean Difference (Final Values)|0.32||||0.2235|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of dressing was compared using wilcoxon rank sum test.|
1675206|NCT01313767|3081732|Superiority or Other||Mean Difference (Final Values)|0.41||||0.1016|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of dressing was compared using wilcoxon rank sum test.|
1675207|NCT01313767|3081732|Superiority or Other||Mean Difference (Final Values)|0.37||||0.122|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of dressing was compared using wilcoxon rank sum test.|
1675208|NCT01313767|3081733|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.4469|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 12 in DAS score of hygiene was compared using wilcoxon rank sum test.|
1675209|NCT01313767|3081733|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.3233|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 8 in DAS score of hygiene was compared using wilcoxon rank sum test.|
1675210|NCT01313767|3081733|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.604|2-Sided||||||Wilcoxon (Mann-Whitney)|||Difference between groups in change from baseline to week 4 in DAS score of hygiene was compared using wilcoxon rank sum test.|
1675211|NCT01313767|3081734|Superiority or Other||Risk Difference (RD)|0.0172||||0.8553|2-Sided||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in thumb flexor was compared using Pearson's chi-square test.|
1675212|NCT01313767|3081734|Superiority or Other||Risk Difference (RD)|-0.1194||||0.2007|2-Sided||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in thumb flexor was compared using Pearson's chi-square test.|
1675213|NCT01313767|3081734|Superiority or Other||Risk Difference (RD)|-0.0654||||0.4623|2-Sided||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in thumb flexor was compared using Pearson's chi-square test.|
1675214|NCT01313767|3081735|Superiority or Other||Risk Difference (RD)|0.0853||||0.2611|2-Sided||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in finger flexor was compared using Pearson's chi-square test|
1675215|NCT01313767|3081735|Superiority or Other||Risk Difference (RD)|-0.1097||||0.1329|2-Sided||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in finger flexor was compared using Pearson's chi-square test|
1675216|NCT01313767|3081735|Superiority or Other||Risk Difference (RD)|0.098||||0.3431|2-Sided||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in finger flexor was compared using Pearson's chi-square test.|
1675217|NCT01313767|3081736|Superiority or Other||Risk Difference (RD)|0.1138||||0.1252|2-Sided||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in elbow flexor was compared using Pearson's chi-square test.|
1675218|NCT01313767|3081736|Superiority or Other||Risk Difference (RD)|0.1164||||0.1176|2-Sided||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in elbow flexor was compared using Pearson's chi-square test.|
1675219|NCT01313767|3081736|Superiority or Other||Risk Difference (RD)|0.098||||0.1802|2-Sided||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in elbow flexor was compared using Pearson's chi-square test.|
1675220|NCT01313767|3081737|Superiority or Other||Risk Difference (RD)|-0.0304||||0.6164|2-Sided||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 12 from baseline in wrist flexor was compared using Pearson's chi-square test.|
1675221|NCT01313767|3081737|Superiority or Other||Risk Difference (RD)|0.0028||||0.9596|2-Sided||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 8 from baseline in wrist flexor was compared using Pearson's chi-square test.|
1675222|NCT01313767|3081737|Superiority or Other||Risk Difference (RD)|-0.07||||0.1585|2-Sided||||||Chi-squared|||Difference between groups in frequency of responders who have improved at least 1-point on the MAS at week 4 from baseline in wrist flexor was compared using Pearson's chi-square test.|
1675223|NCT01313767|3081738|Superiority or Other||Mean Difference (Final Values)|0.09||||0.593|2-Sided||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in thumb flexor MAS score was compared using two sample t-test.|
1675224|NCT01313767|3081738|Superiority or Other||Mean Difference (Final Values)|0.15||||0.3221|2-Sided||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in thumb flexor MAS score was compared using two sample t-test.|
1675225|NCT01313767|3081738|Superiority or Other||Mean Difference (Final Values)|0.19||||0.2284|2-Sided||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in thumb flexor MAS score was compared using two sample t-test.|
1675226|NCT01313767|3081739|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.9316|2-Sided||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in finger flexor MAS score was compared using two sample t-test.|
1675227|NCT01313767|3081739|Superiority or Other||Mean Difference (Final Values)|0.07||||0.6024|2-Sided||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in finger flexor MAS score was compared using two sample t-test.|
1675228|NCT01313767|3081739|Superiority or Other||Mean Difference (Final Values)|0.06||||0.6954|2-Sided||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in finger flexor MAS score was compared using two sample t-test.|
1675229|NCT01313767|3081740|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.0429|2-Sided||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in elbow flexor MAS score was compared using two sample t-test.|
1675230|NCT01313767|3081740|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.0605|2-Sided||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in elbow flexor MAS score was compared using two sample t-test.|
1675231|NCT01313767|3081740|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.0675|2-Sided||||||t-test, 2 sided|||Difference between groups in change from baseline to week 4 in elbow flexor MAS score was compared using two sample t-test.|
1675232|NCT01313767|3081741|Superiority or Other||Mean Difference (Final Values)|0.09||||0.3395|2-Sided||||||t-test, 2 sided|||Difference between groups in change from baseline to week 12 in wrist flexor MAS score was compared using two sample t-test.|
1675233|NCT01313767|3081741|Superiority or Other||Mean Difference (Final Values)|0.07||||0.2591|2-Sided||||||t-test, 2 sided|||Difference between groups in change from baseline to week 8 in wrist flexor MAS score was compared using two sample t-test.|
1675262|NCT01313676|3081766|Superiority or Other||Percent reduction in risk of death|3.6|||||2-Sided|95.0|-14.9|19.2|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100||
1675545|NCT01309282|3082388|Superiority or Other|||||||0.0355|||||||Wilcoxon signed rank test||||
1675234|NCT01313767|3081742|Non-Inferiority or Equivalence|90% of the power, 0.45 of non-inferiority margin|Mean Difference (Final Values)|0.17||||0.1347|2-Sided|95.0|-0.05|0.4|||t-test, 2 sided|||The difference between the two groups was provided with 95% CI. If the upper limit of CI is no greater than 0.45 (non-inferiority margin), the study group was determined not inferior to the control group. Additionally, difference between groups in change from baseline to week 4 in wrist flexor MAS score was compared using two sample t-test.|
1675235|NCT01313689|3081759|Superiority or Other||Hazard Ratio (HR)|1.11||||0.8128|2-Sided|95.0|0.46|2.68||P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Log Rank||Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum||
1675236|NCT01313689|3081759|Superiority or Other||Hazard Ratio (HR)|0.75||||0.1732|2-Sided|95.0|0.48|1.17|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum||
1675237|NCT01313689|3081760|Superiority or Other||Odds Ratio (OR)|1.225||||0.8866|2-Sided|95.0|0.076|19.862||Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum in the strata statement|Regression, Logistic||||
1675238|NCT01313689|3081760|Superiority or Other||Odds Ratio (OR)|1.366||||0.4159|2-Sided|95.0|0.644|2.899||Odds ratios and p-value are based on conditional logistic regression with interval and pooled stratum included in the Strata statement|Regression, Logistic||||
1675239|NCT01313689|3081761|Superiority or Other||Odds Ratio (OR)|999.999||||0.9985|2-Sided|95.0|0.001|999.999|||Regression, Logistic|conditional logistic regression with interval and pooled stratum|||
1675240|NCT01313689|3081761|Superiority or Other||Odds Ratio (OR)|2.942||||0.0223|2-Sided|95.0|1.166|7.424|||Regression, Logistic|conditional logistic regression with interval and pooled stratum|||
1675241|NCT01313689|3081762|Superiority or Other||Hazard Ratio (HR)|0.49||||0.0262|2-Sided|95.0|0.21|1.17|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum||
1675242|NCT01313689|3081762|Superiority or Other||Hazard Ratio (HR)|0.56||||0.003|2-Sided|95.0|0.35|0.87|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum.||
1675243|NCT01313689|3081763|Superiority or Other||Hazard Ratio (HR)|0.54||||0.0837|2-Sided|95.0|0.19|1.53|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum||
1675244|NCT01313689|3081763|Superiority or Other||Hazard Ratio (HR)|0.79||||0.2677|2-Sided|95.0|0.5|1.24|||Log Rank|P-value is based on the stratified log-rank test adjusted for 'interval' and pooled stratum|Hazard ratios are estimated using the Pike estimator, adjusted for 'interval' and pooled stratum||
1675245|NCT01313676|3081764|Superiority or Other||Percent reduction in risk of death|6.2|||||2-Sided|95.0|-15.5|23.9|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100||
1675246|NCT01313676|3081764|Superiority or Other||Hazard Ratio (HR)|0.938||||0.545|2-Sided|95.0|0.761|1.155|||Cox Proportional Hazards Model||||
1675247|NCT01313676|3081764|Superiority or Other||Percent reduction in risk of death|-3.3|||||2-Sided|95.0|-28.1|16.6|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100||
1675248|NCT01313676|3081764|Superiority or Other||Hazard Ratio (HR)|1.033||||0.763|2-Sided|95.0|0.834|1.281|||Cox Proportional Hazards Model||||
1675249|NCT01313676|3081764|Superiority or Other||Percent reduction in risk of death|1.2|||||2-Sided|95.0|-21.7|19.8|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100||
1675250|NCT01313676|3081764|Superiority or Other||Hazard Ratio (HR)|0.988||||0.908|2-Sided|95.0|0.802|1.217|||Cox Proportional Hazards Model||||
1675251|NCT01313676|3081764|Superiority or Other||Percent reduction in risk of CV event|10.4|||||2-Sided|95.0|-11.1|27.7|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100||
1675252|NCT01313676|3081764|Superiority or Other||Hazard Ratio (HR)|0.896||||0.317|2-Sided|95.0|0.723|1.111|||Cox Proportional Hazards Model||||
1675253|NCT01313676|3081764|Superiority or Other||Percent reduction in risk of CV event|7.4|||||2-Sided|95.0|-14.3|25.0|||||Confidence Interval and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100||
1675254|NCT01313676|3081764|Superiority or Other||Hazard Ratio (HR)|0.926||||0.475|2-Sided|95.0|0.75|1.143|||Cox Proportional Hazards Model||||
1675255|NCT01313676|3081765|Superiority or Other||Mean Difference (Final Values)|10.0|Standard Error of the Mean|3.4||0.004|2-Sided|95.0|3.0|16.0|||Mixed Models Analysis||||
1675256|NCT01313676|3081765|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|3.4||0.913|2-Sided|95.0|-6.0|7.0|||Mixed Models Analysis||||
1675257|NCT01313676|3081765|Superiority or Other||Mean Difference (Final Values)|-2.0|Standard Error of the Mean|3.4||0.654|2-Sided|95.0|-8.0|5.0|||Mixed Models Analysis||||
1675258|NCT01313676|3081765|Superiority or Other||Mean Difference (Final Values)|8.0|Standard Error of the Mean|3.5||0.026|2-Sided|95.0|1.0|14.0|||Mixed Models Analysis||||
1675259|NCT01313676|3081765|Superiority or Other||Mean Difference (Final Values)|8.0|Standard Error of the Mean|3.4||0.019|2-Sided|95.0|1.0|15.0|||Mixed Models Analysis||||
1675260|NCT01313676|3081766|Superiority or Other||Percent reduction in risk of death|8.8|||||2-Sided|95.0|-8.5|23.3|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100||
1675261|NCT01313676|3081766|Superiority or Other||Hazard Ratio (HR)|0.912||||0.299|2-Sided|95.0|0.767|1.085|||Cox Proportional Hazards Model||||
1675263|NCT01313676|3081766|Superiority or Other||Hazard Ratio (HR)|0.964||||0.681|2-Sided|95.0|0.808|1.149|||Cox Proportional Hazards Model||||
1675546|NCT01309282|3082389|Superiority or Other|||||||0.01403|||||||Wilcoxon signed rank test||||
1675264|NCT01313676|3081766|Superiority or Other||Percent reduction in risk of death|3.8|||||2-Sided|95.0|-13.9|18.7|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100||
1675265|NCT01313676|3081766|Superiority or Other||Hazard Ratio (HR)|0.962||||0.655|2-Sided|95.0|0.813|1.139|||Cox Proportional Hazards Model||||
1675266|NCT01313676|3081766|Superiority or Other||Percent reduction in risk of death|8.9|||||2-Sided|95.0|-8.1|23.3|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100||
1675267|NCT01313676|3081766|Superiority or Other||Hazard Ratio (HR)|0.911||||0.284|2-Sided|95.0|0.767|1.081|||Cox Proportional Hazards Model||||
1675268|NCT01313676|3081766|Superiority or Other||Percent reduction in risk of death|12.2|||||2-Sided|95.0|-4.2|26.1|||||Confidence Interval (95%) and Estimated Value is presented for the percent reduction in risk of death at any time up to or on the CED, calculated as (1-hazard ratio)*100||
1675269|NCT01313676|3081766|Superiority or Other||Hazard Ratio (HR)|0.878||||0.137|2-Sided|95.0|0.739|1.042|||Cox Proportional Hazards Model||||
1675270|NCT01313663|3081781|Superiority or Other||Hazard Ratio (HR)|0.92|||||2-Sided|90.0|0.32|2.65|||||HRs were estimated using the Pike estimator. The hazard ratio and p-value from the stratified log-rank test were adjusted for disease stage at Baseline only, due to sparse data.||
1675271|NCT01313650|3081785|Superiority or Other||Least squares mean difference|0.095|||<|0.001|2-Sided|95.0|0.06|0.13|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 minus VI 25 µg.||
1675272|NCT01313650|3081785|Superiority or Other||Least squares mean difference|0.052|||<|0.004|2-Sided|95.0|0.017|0.087|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 minus UMEC 62.5 µg.||
1675273|NCT01313650|3081785|Superiority or Other||Least squares mean difference|0.167|||<|0.001|2-Sided|95.0|0.128|0.207|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 62.5/25 µg minus Placebo.||
1675274|NCT01313650|3081785|Superiority or Other||Least squares mean difference|0.072|||<|0.001|2-Sided|95.0|0.032|0.112|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=VI 25 µg minus Placebo.||
1675275|NCT01313650|3081785|Superiority or Other||Least squares mean difference|0.115|||<|0.001|2-Sided|95.0|0.076|0.155|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC 62.5 µg minus Placebo.||
1675276|NCT01313637|3081789|Superiority or Other||Least squares mean difference|0.114|||<|0.001|2-Sided|95.0|0.081|0.148|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 minus VI 25 µg.||
1675277|NCT01313637|3081789|Superiority or Other||Least squares mean difference|0.079|||<|0.001|2-Sided|95.0|0.046|0.112|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 minus UMEC 125 µg.||
1675278|NCT01313637|3081789|Superiority or Other||Least squares mean difference|0.238|||<|0.001|2-Sided|95.0|0.2|0.276|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC/VI 125/25 µg minus Placebo.||
1675279|NCT01313637|3081789|Superiority or Other||Least squares mean difference|0.124|||<|0.001|2-Sided|95.0|0.086|0.162|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=VI 25 µg minus Placebo.||
1675280|NCT01313637|3081789|Superiority or Other||Least squares mean difference|0.16|||<|0.001|2-Sided|95.0|0.122|0.198|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Least squares mean difference=UMEC 125 µg minus Placebo.||
1675281|NCT01313624|3081791|Superiority or Other||Difference in least squares mean|1.3||||0.56|2-Sided|95.0|-3.0|5.6||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM||||
1675282|NCT01313624|3081792|Superiority or Other||Difference in least squares mean|0.8||||0.68|2-Sided|95.0|-3.1|4.7||P-value was based on T-test from mixed-effect model repeated measures (MMRM).|MMRM||||
1675283|NCT01313520|3081797|Superiority or Other||Effect Size|1.1|||||2-Sided|90.0|0.64|1.55|||||||
1675284|NCT01313520|3081798|Superiority or Other||Effect Size|1.4|||||2-Sided|90.0|0.92|1.87|||||||
1675285|NCT01313520|3081799|Superiority or Other|||||||0.0005|||||||van Elteren test||||
1675286|NCT01313520|3081800|Superiority or Other|||||||0.001|||||||van Elteren test||||
1675287|NCT01313520|3081801|Superiority or Other||||||<|0.0001|||||||Constrained longitudinal data analysis||||
1675288|NCT01313520|3081802|Superiority or Other|||||||0.011|||||||Fisher Exact||||
1675289|NCT01313520|3081803|Superiority or Other|||||||0.048|||||||Fisher Exact||||
1675290|NCT01313520|3081804|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.001|2-Sided|95.0|-0.4|-0.1|||Constrained Longitudinal Data Analysis||||
1675291|NCT01313494|3081831|Superiority or Other||LSM Difference|0.071|Standard Error of the Mean|0.012|<|0.0001|2-Sided|95.0|0.046|0.095|||Repeated measures ANCOVA|Independent variables: treatment, baseline value of pre-bronchodilator FEV1, time and a treatment-by-time interaction.||The primary endpoint was tested in a confirmatory manner with a 2-sided significance level of 5%.|
1675292|NCT01313286|3081878|Superiority or Other||Ratio of Geometric Least Square means|1.18|||||2-Sided|90.0|1.07|1.31|||||||
1675293|NCT01313286|3081879|Superiority or Other||Ratio of Geometric Least Square means|1.08|||||2-Sided|90.0|1.0|1.16|||||||
1675294|NCT01313221|3081905|Superiority or Other||Mean Difference (Final Values)|16.56|Standard Error of the Mean|9.53|||2-Sided|95.0|-2.21|35.32||||||Difference in change from Week 12 to Week 20|
1675295|NCT01313221|3081905|Superiority or Other||Mean Difference (Final Values)|11.23|Standard Error of the Mean|8.31|||2-Sided|95.0|-5.13|27.6||||||Difference in change from Week 12 to Week 16|
1675296|NCT01313221|3081906|Superiority or Other||Mean Difference (Final Values)|16.16|Standard Error of the Mean|9.99|||2-Sided|95.0|-3.5|35.82|||||Adjusted for treatment in a mixed model||
1675547|NCT01309282|3082390|Superiority or Other|||||||0.0078|||||||Wilcoxon signed rank test||||
1675297|NCT01313208|3081948|Superiority or Other||Odds Ratio (OR)|1.83||||0.055|2-Sided|95.0|0.99|3.41|||Mantel Haenszel|P-value from Mantel-Haenszel test stratified by participant's baseline methotrexate use (yes or no).|Etanercept/Placebo||
1675298|NCT01312961|3081973|Superiority||Odds Ratio (OR)|0.077|||<|0.0001|2-Sided|95.0|0.021|0.28||Threshold for significance at 0.05 level.|Regression, Logistic||Dupilumab 300 mg vs. Placebo|Analysis was performed using a logistic regression model with treatment groups and stratification factor (prior ICS/LABA combination therapy dose) as covariates.|
1675299|NCT01312909|3081985|Superiority||Odds Ratio (OR)|2.79||||0.0188|2-Sided|95.0|1.19|6.55|||Regression, Logistic|||Week 9 through Week 52: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.|
1675300|NCT01312909|3081985|Superiority||Odds Ratio (OR)|0.99||||0.9874|2-Sided|95.0|0.37|2.65|||Regression, Logistic|||Week 9 through Week 52: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.|
1675301|NCT01312909|3081985|Superiority||Odds Ratio (OR)|2.26||||0.0335|2-Sided|95.0|1.07|4.79|||Regression, Logistic|||Week 9 through Week 24: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.|
1675302|NCT01312909|3081985|Superiority||Odds Ratio (OR)|0.8||||0.6133|2-Sided|95.0|0.34|1.9|||Regression, Logistic|||Week 9 through Week 24: Odds ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center, age strata and body weight strata.|
1675303|NCT01312909|3081986|Superiority||LS mean difference|-0.77|Standard Error of the Mean|0.62||0.2166|2-Sided|95.0|-1.99|0.45|||Longitudinal repeated measures model|||Week 52: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.|
1675304|NCT01312909|3081986|Superiority||LS mean difference|0.18|Standard Error of the Mean|0.62||0.773|2-Sided|95.0|-1.03|1.38|||Longitudinal repeated measures model|||Week 52: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.|
1675305|NCT01312909|3081986|Superiority||LS mean difference|-0.72|Standard Error of the Mean|0.61||0.2356|2-Sided|95.0|-1.92|0.47|||Longitudinal repeated measures model|||Week 24: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.|
1675306|NCT01312909|3081986|Superiority||LS mean difference|-0.34|Standard Error of the Mean|0.6||0.5676|2-Sided|95.0|-1.53|0.84|||Longitudinal repeated measures model|||Week 24: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.|
1675307|NCT01312909|3081986|Superiority||LS mean difference|-0.18|Standard Error of the Mean|0.59||0.7574|2-Sided|95.0|-1.35|0.98|||Longitudinal repeated measures model|||Week 12: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.|
1675308|NCT01312909|3081986|Superiority||Least square (LS) mean difference|-0.54|Standard Error of the Mean|0.58||0.354|2-Sided|95.0|-1.69|0.6|||Longitudinal repeated measures model|||Week 12: Analysis was performed using longitudinal repeated measures model with the change from baseline average number of Cigarettes Smoked as the dependent variable, including terms treatment, visit, age strata, body weight strata, pooled center, baseline measure and treatment by visit interaction.|
1675309|NCT01312909|3081988|Superiority||Odds Ratio (OR)|1.79||||0.13|2-Sided|95.0|0.84|3.78|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 52|
1675310|NCT01312909|3081988|Superiority||Odds Ratio (OR)|1.25||||0.5616|2-Sided|95.0|0.58|2.69|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 52|
1675311|NCT01312909|3081988|Superiority||Odds Ratio (OR)|1.46||||0.2917|2-Sided|95.0|0.72|2.96|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 24|
1675312|NCT01312909|3081988|Superiority||Odds Ratio (OR)|1.23||||0.5647|2-Sided|95.0|0.61|2.5|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 24|
1675313|NCT01312909|3081988|Superiority||Odds Ratio (OR)|1.79||||0.0932|2-Sided|95.0|0.91|3.51|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 12|
1675314|NCT01312909|3081988|Superiority||Odds Ratio (OR)|1.21||||0.5793|2-Sided|95.0|0.62|2.38|||Regression, Logistic|Odds ratios and p-values were obtained from separate logistic regression models of treatment, pooled center, age strata and body weight strata.||Week 12|
1675315|NCT01312909|3081989|Superiority||Odds Ratio (OR)|1.73||||0.1114|2-Sided|95.0|0.88|3.39||Threshold for significance at 0.05 level.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model with terms treatment, age strata, body weight strata and pooled center. A testing order was used to control type I error. 1mg Varenicline twice daily group was tested against placebo first, and if statistically significant difference was observed, the 0.5 mg Varenicline twice daily group was tested against placebo.|
1675347|NCT01311661|3082095|Superiority or Other||Mean Difference (Final Values)|157.306|Standard Error of the Mean|18.885|<|0.0001||95.0|120.192|194.42|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675316|NCT01312909|3081989|Superiority||Odds Ratio (OR)|1.18||||0.6337|2-Sided|95.0|0.59|2.37||Threshold for significance at 0.05 level.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model with terms treatment, age strata, body weight strata and pooled center. A testing order was used to control type I error. 1mg Varenicline twice daily group was tested against placebo first, and if statistically significant difference was observed, the 0.5 mg Varenicline twice daily group was tested against placebo.|
1675317|NCT01312766|3082024|Superiority or Other|||||||0.61|||||||Fisher Exact||||
1675318|NCT01312766|3082025|Superiority or Other|||||||0.04|||||||ANOVA||||
1675319|NCT01312766|3082026|Superiority or Other||||||<|0.001|||||||ANOVA||||
1675320|NCT01312766|3082027|Superiority or Other|||||||0.004|||||||ANOVA||||
1675321|NCT01312766|3082028|Superiority or Other|||||||0.002|||||||ANOVA||||
1675322|NCT01312766|3082029|Superiority or Other|||||||0.61|||||||Fisher Exact||||
1675323|NCT01312766|3082032|Superiority or Other|||||||0.02|||||||ANOVA||||
1675324|NCT01312766|3082033|Superiority or Other|||||||0.9|||||||Fisher Exact||||
1675325|NCT01312766|3082035|Superiority or Other|||||||0.25|||||||ANOVA||||
1675326|NCT01312766|3082036|Non-Inferiority or Equivalence|The one-way Analysis of Variance with Least-Squares means was performed to calculate the 95% Confidence Interval of the difference between the two treatments. If the lower bound of the 95% Confidence Interval of the difference between means (hMG-IBSA minus Menopur®) was greater than -2.1, then hMG-IBSA would be considered to be not-inferior to the comparator.|Mean Difference (Final Values)|1.9||||0.012|2-Sided|95.0|0.43|3.43|||ANOVA||||
1675327|NCT01312467|3082043|Superiority or Other||||||>|0.773|||||||A paired t-test||||
1675328|NCT01312129|3082059|Superiority or Other||||||=|0||||||=0.05 is the actual computed p-value via the ANOVA.|ANOVA|The ANOVA is comparing the % increase in BOLD response above baseline during cue presentation (Alcohol vs. Control) b/w placebo & Sulfasalazine .|||
1675329|NCT01312038|3082060|Superiority or Other||||||=|0|||||||Paired T-test|df = 31||Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of 200 daPa.|
1675330|NCT01312038|3082060|Superiority or Other||||||=|0|||||||Paired T-test|df=34||Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of -200 daPa.|
1675331|NCT01311687|3082079|Superiority or Other||Hazard Ratio (HR)|0.46|||<|0.001|2-Sided|95.0|0.36|0.59|||Stratified Log Rank Test|Stratified by age, diseases population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone||
1675332|NCT01311687|3082080|Superiority or Other||Odds Ratio (OR)|8.44|||<|0.001|2-Sided|95.0|3.32|21.42|||Fisher Exact||Odds ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone||
1675333|NCT01311687|3082081|Superiority or Other||Odds Ratio (OR)|7.53|||<|0.001|2-Sided|95.0|3.19|17.77|||Fisher Exact||Odds ratio is for pomalidomide plus low-dose dexamethasone : high dose dexamethasone||
1675334|NCT01311687|3082082|Superiority||Hazard Ratio (HR)|0.74||||0.005|2-Sided|95.0|0.6|0.91|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone||
1675335|NCT01311687|3082083|Superiority or Other||Hazard Ratio (HR)|0.7||||0.009|2-Sided|95.0|0.54|0.92|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone||
1675336|NCT01311687|3082084|Superiority or Other||Hazard Ratio (HR)|0.53|||<|0.001|2-Sided|95.0|0.37|0.74|||Log Rank||Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone||
1675337|NCT01311687|3082086|Superiority or Other||Hazard Ratio (HR)|0.49|||<|0.001|2-Sided|95.0|0.39|0.61|||Stratified log-rank test|Stratified by age, disease population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone||
1675338|NCT01311687|3082087|Superiority or Other||Hazard Ratio (HR)|0.45|||<|0.001|2-Sided|95.0|0.35|0.59|||Stratified Log Rank Test|Stratified by age, disease population, and prior number of anti myeloma therapy.|Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone||
1675339|NCT01311661|3082089|Superiority or Other||Mean Difference (Final Values)|-0.302|Standard Error of the Mean|0.053|<|0.0001||95.0|-0.405|-0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675340|NCT01311661|3082089|Superiority or Other||Mean Difference (Final Values)|-0.301|Standard Error of the Mean|0.053|<|0.0001||95.0|-0.405|-0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675341|NCT01311661|3082089|Superiority or Other||Mean Difference (Final Values)|-0.296|Standard Error of the Mean|0.053|<|0.0001||95.0|-0.4|-0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675342|NCT01311661|3082089|Superiority or Other||Mean Difference (Final Values)|-0.357|Standard Error of the Mean|0.053|<|0.0001||95.0|-0.461|-0.253|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675343|NCT01311661|3082094|Superiority or Other||Mean Difference (Final Values)|-0.546|Standard Error of the Mean|0.114|<|0.0001||95.0|-0.77|-0.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675344|NCT01311661|3082094|Superiority or Other||Mean Difference (Final Values)|-0.588|Standard Error of the Mean|0.114|<|0.0001||95.0|-0.813|-0.364|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675345|NCT01311661|3082094|Superiority or Other||Mean Difference (Final Values)|-0.637|Standard Error of the Mean|0.114|<|0.0001||95.0|-0.862|-0.412|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675346|NCT01311661|3082094|Superiority or Other||Mean Difference (Final Values)|-0.554|Standard Error of the Mean|0.115|<|0.0001||95.0|-0.78|-0.329|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675348|NCT01311661|3082095|Superiority or Other||Mean Difference (Final Values)|142.136|Standard Error of the Mean|18.885|<|0.0001||95.0|105.021|179.251|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675349|NCT01311661|3082095|Superiority or Other||Mean Difference (Final Values)|132.138|Standard Error of the Mean|18.92|<|0.0001||95.0|94.954|169.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675350|NCT01311661|3082095|Superiority or Other||Mean Difference (Final Values)|142.251|Standard Error of the Mean|18.997|<|0.0001||95.0|104.916|179.586|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675351|NCT01311661|3082096|Superiority or Other||Mean Difference (Final Values)|150.441|Standard Error of the Mean|19.369|<|0.0001||95.0|112.377|188.505|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675352|NCT01311661|3082096|Superiority or Other||Mean Difference (Final Values)|149.268|Standard Error of the Mean|19.369|<|0.0001||95.0|111.204|187.333|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675353|NCT01311661|3082096|Superiority or Other||Mean Difference (Final Values)|155.097|Standard Error of the Mean|19.406|<|0.0001||95.0|116.961|193.234|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675354|NCT01311661|3082096|Superiority or Other||Mean Difference (Final Values)|173.391|Standard Error of the Mean|19.484|<|0.0001||95.0|135.099|211.682|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675355|NCT01311661|3082097|Superiority or Other||Mean Difference (Final Values)|-0.689|Standard Error of the Mean|0.344||0.0458||95.0|-1.366|-0.013|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675356|NCT01311661|3082097|Superiority or Other||Mean Difference (Final Values)|-1.738|Standard Error of the Mean|0.344|<|0.0001||95.0|-2.415|-1.062|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675357|NCT01311661|3082097|Superiority or Other||Mean Difference (Final Values)|-1.426|Standard Error of the Mean|0.345|<|0.0001||95.0|-2.104|-0.748|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675358|NCT01311661|3082097|Superiority or Other||Mean Difference (Final Values)|-1.581|Standard Error of the Mean|0.346|<|0.0001||95.0|-2.262|-0.9|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675359|NCT01311661|3082098|Superiority or Other||Mean Difference (Final Values)|33.327|Standard Error of the Mean|3.028|<|0.0001||95.0|27.375|39.278|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675360|NCT01311661|3082098|Superiority or Other||Mean Difference (Final Values)|31.816|Standard Error of the Mean|3.028|<|0.0001||95.0|25.864|37.767|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675361|NCT01311661|3082098|Superiority or Other||Mean Difference (Final Values)|32.056|Standard Error of the Mean|3.034|<|0.0001||95.0|26.094|38.018|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675362|NCT01311661|3082098|Superiority or Other||Mean Difference (Final Values)|28.87|Standard Error of the Mean|3.046|<|0.0001||95.0|22.884|34.856|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675363|NCT01311661|3082099|Superiority or Other||Mean Difference (Final Values)|28.895|Standard Error of the Mean|3.161|<|0.0001||95.0|22.683|35.107|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675364|NCT01311661|3082099|Superiority or Other||Mean Difference (Final Values)|31.66|Standard Error of the Mean|3.161|<|0.0001||95.0|25.448|37.872|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675365|NCT01311661|3082099|Superiority or Other||Mean Difference (Final Values)|32.632|Standard Error of the Mean|3.167|<|0.0001||95.0|26.409|38.855|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675366|NCT01311661|3082099|Superiority or Other||Mean Difference (Final Values)|32.957|Standard Error of the Mean|3.18|<|0.0001||95.0|26.709|39.206|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675367|NCT01311661|3082100|Superiority or Other||Mean Difference (Final Values)|0.481|Standard Error of the Mean|0.067|<|0.0001||95.0|0.349|0.613|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675368|NCT01311661|3082100|Superiority or Other||Mean Difference (Final Values)|0.603|Standard Error of the Mean|0.067|<|0.0001||95.0|0.471|0.736|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675369|NCT01311661|3082100|Superiority or Other||Mean Difference (Final Values)|0.41|Standard Error of the Mean|0.068|<|0.0001||95.0|0.277|0.543|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675548|NCT01309282|3082391|Superiority or Other|||||||0.0078|||||||Wilcoxon signed rank test||||
1675712|NCT01306877|3082743|Superiority or Other|||||||0.1844|||||||Wilcoxon (Mann-Whitney)||||
1675370|NCT01311661|3082100|Superiority or Other||Mean Difference (Final Values)|0.529|Standard Error of the Mean|0.068|<|0.0001||95.0|0.396|0.662|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675371|NCT01311661|3082101|Superiority or Other||Mean Difference (Final Values)|0.623|Standard Error of the Mean|0.079|<|0.0001||95.0|0.468|0.777|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675372|NCT01311661|3082101|Superiority or Other||Mean Difference (Final Values)|0.594|Standard Error of the Mean|0.079|<|0.0001||95.0|0.439|0.749|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675373|NCT01311661|3082101|Superiority or Other||Mean Difference (Final Values)|0.522|Standard Error of the Mean|0.079|<|0.0001||95.0|0.366|0.677|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675374|NCT01311661|3082101|Superiority or Other||Mean Difference (Final Values)|0.591|Standard Error of the Mean|0.079|<|0.0001||95.0|0.436|0.746|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675375|NCT01311661|3082102|Superiority or Other||Mean Difference (Final Values)|0.643|Standard Error of the Mean|0.063|<|0.0001||95.0|0.519|0.766|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675376|NCT01311661|3082102|Superiority or Other||Mean Difference (Final Values)|0.667|Standard Error of the Mean|0.063|<|0.0001||95.0|0.544|0.79|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675377|NCT01311661|3082102|Superiority or Other||Mean Difference (Final Values)|0.577|Standard Error of the Mean|0.063|<|0.0001||95.0|0.453|0.701|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675378|NCT01311661|3082102|Superiority or Other||Mean Difference (Final Values)|0.641|Standard Error of the Mean|0.063|<|0.0001||95.0|0.516|0.765|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675379|NCT01311661|3082103|Superiority or Other||Mean Difference (Final Values)|0.599|Standard Error of the Mean|0.067|<|0.0001||95.0|0.467|0.732|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675380|NCT01311661|3082103|Superiority or Other||Mean Difference (Final Values)|0.702|Standard Error of the Mean|0.068|<|0.0001||95.0|0.569|0.835|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675381|NCT01311661|3082103|Superiority or Other||Mean Difference (Final Values)|0.564|Standard Error of the Mean|0.068|<|0.0001||95.0|0.431|0.698|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675382|NCT01311661|3082103|Superiority or Other||Mean Difference (Final Values)|0.665|Standard Error of the Mean|0.068|<|0.0001||95.0|0.532|0.799|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675383|NCT01311661|3082104|Superiority or Other||Mean Difference (Final Values)|0.685|Standard Error of the Mean|0.065|<|0.0001||95.0|0.558|0.813|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675384|NCT01311661|3082104|Superiority or Other||Mean Difference (Final Values)|0.631|Standard Error of the Mean|0.065|<|0.0001||95.0|0.503|0.758|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675385|NCT01311661|3082104|Superiority or Other||Mean Difference (Final Values)|0.601|Standard Error of the Mean|0.065|<|0.0001||95.0|0.473|0.73|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675386|NCT01311661|3082104|Superiority or Other||Mean Difference (Final Values)|0.629|Standard Error of the Mean|0.065|<|0.0001||95.0|0.5|0.757|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675387|NCT01311661|3082105|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|0.028|<|0.0001||95.0|0.057|0.166|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675388|NCT01311661|3082105|Superiority or Other||Mean Difference (Final Values)|0.118|Standard Error of the Mean|0.028|<|0.0001||95.0|0.063|0.172|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675389|NCT01311661|3082105|Superiority or Other||Mean Difference (Final Values)|0.092|Standard Error of the Mean|0.028|<|0.001||95.0|0.037|0.147|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675390|NCT01311661|3082105|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.028|<|0.0001||95.0|0.055|0.165|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675391|NCT01311661|3082106|Superiority or Other||Mean Difference (Final Values)|0.126|Standard Error of the Mean|0.026|<|0.0001||95.0|0.075|0.177|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675392|NCT01311661|3082106|Superiority or Other||Mean Difference (Final Values)|0.144|Standard Error of the Mean|0.026|<|0.0001||95.0|0.093|0.195|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1676030|NCT01301079|3083415|Superiority or Other|||||||0.652|||||||t-test, 2 sided||||
1675393|NCT01311661|3082106|Superiority or Other||Mean Difference (Final Values)|0.124|Standard Error of the Mean|0.026|<|0.0001||95.0|0.073|0.176|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675394|NCT01311661|3082106|Superiority or Other||Mean Difference (Final Values)|0.136|Standard Error of the Mean|0.026|<|0.0001||95.0|0.084|0.187|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675395|NCT01311661|3082107|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.022|<|0.0001||95.0|0.098|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675396|NCT01311661|3082107|Superiority or Other||Mean Difference (Final Values)|0.156|Standard Error of the Mean|0.022|<|0.0001||95.0|0.113|0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675397|NCT01311661|3082107|Superiority or Other||Mean Difference (Final Values)|0.128|Standard Error of the Mean|0.022|<|0.0001||95.0|0.085|0.171|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675398|NCT01311661|3082107|Superiority or Other||Mean Difference (Final Values)|0.145|Standard Error of the Mean|0.022|<|0.0001||95.0|0.102|0.188|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675399|NCT01311661|3082108|Superiority or Other||Mean Difference (Final Values)|0.135|Standard Error of the Mean|0.024|<|0.0001||95.0|0.087|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675400|NCT01311661|3082108|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.024|<|0.0001||95.0|0.123|0.218|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675401|NCT01311661|3082108|Superiority or Other||Mean Difference (Final Values)|0.137|Standard Error of the Mean|0.024|<|0.0001||95.0|0.09|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675402|NCT01311661|3082108|Superiority or Other||Mean Difference (Final Values)|0.158|Standard Error of the Mean|0.024|<|0.0001||95.0|0.11|0.206|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675403|NCT01311661|3082109|Superiority or Other||Mean Difference (Final Values)|0.147|Standard Error of the Mean|0.022|<|0.0001||95.0|0.103|0.191|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675404|NCT01311661|3082109|Superiority or Other||Mean Difference (Final Values)|0.142|Standard Error of the Mean|0.022|<|0.0001||95.0|0.098|0.186|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675405|NCT01311661|3082109|Superiority or Other||Mean Difference (Final Values)|0.122|Standard Error of the Mean|0.023|<|0.0001||95.0|0.078|0.167|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675406|NCT01311661|3082109|Superiority or Other||Mean Difference (Final Values)|0.136|Standard Error of the Mean|0.023|<|0.0001||95.0|0.091|0.18|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675407|NCT01311661|3082110|Superiority or Other||Mean Difference (Final Values)|0.172|Standard Error of the Mean|0.024|<|0.0001||95.0|0.125|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675408|NCT01311661|3082110|Superiority or Other||Mean Difference (Final Values)|0.196|Standard Error of the Mean|0.024|<|0.0001||95.0|0.149|0.243|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675409|NCT01311661|3082110|Superiority or Other||Mean Difference (Final Values)|0.101|Standard Error of the Mean|0.024|<|0.0001||95.0|0.054|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675410|NCT01311661|3082110|Superiority or Other||Mean Difference (Final Values)|0.156|Standard Error of the Mean|0.024|<|0.0001||95.0|0.109|0.203|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675411|NCT01311661|3082111|Superiority or Other||Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.023|<|0.0001||95.0|0.165|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675412|NCT01311661|3082111|Superiority or Other||Mean Difference (Final Values)|0.222|Standard Error of the Mean|0.023|<|0.0001||95.0|0.177|0.267|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675413|NCT01311661|3082111|Superiority or Other||Mean Difference (Final Values)|0.153|Standard Error of the Mean|0.023|<|0.0001||95.0|0.108|0.198|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675414|NCT01311661|3082111|Superiority or Other||Mean Difference (Final Values)|0.183|Standard Error of the Mean|0.023|<|0.0001||95.0|0.138|0.228|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675415|NCT01311661|3082112|Superiority or Other||Mean Difference (Final Values)|0.198|Standard Error of the Mean|0.022|<|0.0001||95.0|0.156|0.241|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1676031|NCT01301079|3083416|Superiority or Other|||||||0.019|||||||t-test, 2 sided||||
1675416|NCT01311661|3082112|Superiority or Other||Mean Difference (Final Values)|0.242|Standard Error of the Mean|0.022|<|0.0001||95.0|0.2|0.285|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675417|NCT01311661|3082112|Superiority or Other||Mean Difference (Final Values)|0.144|Standard Error of the Mean|0.022|<|0.0001||95.0|0.102|0.187|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675418|NCT01311661|3082112|Superiority or Other||Mean Difference (Final Values)|0.196|Standard Error of the Mean|0.022|<|0.0001||95.0|0.153|0.238|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675419|NCT01311661|3082113|Superiority or Other||Mean Difference (Final Values)|0.219|Standard Error of the Mean|0.02|<|0.0001||95.0|0.181|0.258|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675420|NCT01311661|3082113|Superiority or Other||Mean Difference (Final Values)|0.214|Standard Error of the Mean|0.02|<|0.0001||95.0|0.175|0.253|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675421|NCT01311661|3082113|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.02|<|0.0001||95.0|0.121|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675422|NCT01311661|3082113|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.02|<|0.0001||95.0|0.15|0.229|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675423|NCT01311661|3082114|Superiority or Other||Mean Difference (Final Values)|0.209|Standard Error of the Mean|0.02|<|0.0001||95.0|0.17|0.247|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1675424|NCT01311661|3082114|Superiority or Other||Mean Difference (Final Values)|0.228|Standard Error of the Mean|0.02|<|0.0001||95.0|0.19|0.266|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg bid minus Placebo||
1675425|NCT01311661|3082114|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.02|<|0.0001||95.0|0.111|0.189|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1675426|NCT01311661|3082114|Superiority or Other||Mean Difference (Final Values)|0.191|Standard Error of the Mean|0.02|<|0.0001||95.0|0.152|0.229|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2.5 mcg bid minus Placebo||
1675427|NCT01311557|3082120|Non-Inferiority or Equivalence|A two-sided 95% CI was constructed around each of the ratios: anti-Fimbriae types 2 and 3 (FIM) GMT Group 1 / GMT Group 2. The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025.|GMT Ratio|0.882|||||2-Sided|95.0|0.731|1.06|||||||
1675428|NCT01311557|3082120|Non-Inferiority or Equivalence|"A two-sided 95% CI was constructed around each of the ratios: Anti-Pertactin (PRN) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|1.05|||||2-Sided|95.0|0.928|1.18|||||||
1675429|NCT01311557|3082120|Non-Inferiority or Equivalence|"A two-sided 95% CI was constructed around each of the ratios: anti-Filamentous hemagglutinin (FHA) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|1.03|||||2-Sided|95.0|0.944|1.13|||||||
1675430|NCT01311557|3082120|Non-Inferiority or Equivalence|"A two-sided 95% confidence interval (CI) was constructed around each of the ratios: Pertussis toxoid (PT) GMT Group 1 / GMT Group 2.~The GMT hypothesis was supported by the data if the lower bound of the calculated 95% CI was > 0.67. This was the equivalent of testing the null hypothesis using a one-sided type I error rate of 0.025."|GMT Ratio|0.94|||||2-Sided|95.0|0.843|1.05|||||||
1675431|NCT01311505|3082129|Superiority or Other||Ratio of adjusted geometric means|100.25|||||2-Sided|90.0|94.44|106.41||||||Natural log transformed AUC(0-∞) of rifampicin was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1675432|NCT01311505|3082131|Superiority or Other||Ratio of adjusted geometric means|98.24|||||2-Sided|90.0|87.77|109.97||||||20 participants (10 per sequence) provided at least 94% power that 90% CI for ratio of test to reference for Cmax of rifampicin lie within acceptance region of 80%-125%. Intra-participant CV estimate of approximately 16.43% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.|
1675433|NCT01311505|3082132|Superiority or Other||Ratio of adjusted geometric means|98.9|||||2-Sided|90.0|92.98|105.2||||||20 participants (10 per sequence) provided at least 98% power that 90% confidence interval (CI) for ratio of test to reference for AUC(0-t) of rifampicin lie within acceptance region of 80%-125%. Intra-participant coefficient of variation (CV) estimate of approximately 13.48% for AUC(0-t) was used for this power calculation. Natural log transformed AUC(0-t) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.|
1675434|NCT01310699|3082159|Superiority|||||||0.18|||||||Chi-squared||||
1675435|NCT01310699|3082160|Superiority|||||||0.21|||||||Chi-squared||||
1675449|NCT01309841|3082246|Superiority or Other||LS mean difference|-0.13||||0.062|2-Sided|95.0|-0.26|0.01||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1676032|NCT01301079|3083417|Superiority or Other|||||||0.999|||||||t-test, 2 sided||||
1675436|NCT01310400|3082212|Non-Inferiority or Equivalence|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|10.7||||0.0029|2-Sided|95.0|3.7|17.6||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain.|
1675437|NCT01310400|3082212|Non-Inferiority or Equivalence|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|20.2||||0|2-Sided|95.0|13.5|27.0||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain.|
1675438|NCT01310400|3082212|Non-Inferiority or Equivalence|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|0.9||||0.7493|2-Sided|95.0|-4.5|6.2||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain.|
1675439|NCT01310400|3082212|Non-Inferiority or Equivalence|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|8.0|||<|0.001|2-Sided|95.0|3.3|12.7||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain.|
1675440|NCT01310400|3082212|Non-Inferiority or Equivalence|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|-3.0|||<|0.1465|2-Sided|95.0|-7.0|1.0||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain.|
1675441|NCT01310400|3082212|Non-Inferiority or Equivalence|This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group.|Difference in seroconversion rates|4.5|||<|0.0036|2-Sided|95.0|1.4|7.5||The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint|Chi-squared|||This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain.|
1675442|NCT01309997|3082228|Superiority or Other|||||||0.64|||||||Wilcoxon (Mann-Whitney)||||
1675443|NCT01309997|3082228|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1675444|NCT01309841|3082245|Superiority or Other||LS mean difference|-0.18||||0.141|2-Sided|95.0|-0.41|0.06|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Due to convergence issues, study pooled center is also included as a fixed, rather than random effect.|
1675445|NCT01309841|3082245|Superiority or Other||LS mean difference|-0.02||||0.831|2-Sided|95.0|-0.25|0.2|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Due to convergence issues, study pooled center is also included as a fixed, rather than random effect.|
1675446|NCT01309841|3082246|Superiority or Other||LS mean difference|-0.16||||0.072|2-Sided|95.0|-0.34|0.01||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675447|NCT01309841|3082246|Superiority or Other||LS mean difference|-0.11||||0.202|2-Sided|95.0|-0.29|0.06||Analysis for change in PAC-SYM stool symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675448|NCT01309841|3082246|Superiority or Other||LS mean difference|-0.21||||0.003|2-Sided|95.0|-0.35|-0.07||Analysis for change in PAC-SYM rectal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675523|NCT01309659|3082337|Superiority or Other|||||||0.308||||||Correlation between ferritin and change in hemoglobin in the immediate intervention group. Testing the correlation equal to 0.|t-test, 2 sided||||
1675524|NCT01309360|3082370|Superiority or Other|||||||1|||||||Fisher Exact||||
1675450|NCT01309841|3082246|Superiority or Other||LS mean difference|-0.03||||0.749|2-Sided|95.0|-0.18|0.13||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675451|NCT01309841|3082246|Superiority or Other||Slope|0.02||||0.849|2-Sided|95.0|-0.14|0.17||Analysis for change in PAC-SYM abdominal symptoms subscore from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675452|NCT01309841|3082246|Superiority or Other||LS mean difference|-0.12||||0.089|2-Sided|95.0|-0.26|0.02||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675453|NCT01309841|3082246|Superiority or Other||LS mean difference|-0.08||||0.273|2-Sided|95.0|-0.21|0.06||Analysis for change in PAC-SYM total score from baseline (Week 1) to end of treatment (Week 12)|Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675454|NCT01309841|3082248|Superiority or Other||LS mean difference|0.99|||<|0.001|2-Sided|95.0|0.57|1.41|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675455|NCT01309841|3082248|Superiority or Other||LS mean difference|0.54|||<|0.011|2-Sided|95.0|0.12|0.96|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675456|NCT01309841|3082249|Superiority or Other||LS mean difference|8.59|||<|0.001|2-Sided|95.0|4.04|13.14|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675457|NCT01309841|3082249|Superiority or Other||LS mean difference|3.87|||<|0.094|2-Sided|95.0|-0.66|8.39|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675458|NCT01309841|3082250|Superiority or Other||LS mean difference|0.18||||0.042|2-Sided|95.0|0.01|0.36|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675459|NCT01309841|3082250|Superiority or Other||LS mean difference|0.05||||0.564|2-Sided|95.0|-0.12|0.23|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675460|NCT01309841|3082251|Superiority or Other||LS mean difference|-0.18||||0.008|2-Sided|95.0|-0.32|-0.05|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675461|NCT01309841|3082251|Superiority or Other||LS mean difference|-0.09||||0.176|2-Sided|95.0|-0.23|0.04|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response (LIR, non-LIR), treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675462|NCT01309841|3082252|Superiority or Other||Ls mean difference|0.82|||<|0.001|2-Sided|95.0|0.51|1.13|||Mixed Models Analysis|||Analysis via MMRM with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675463|NCT01309841|3082252|Superiority or Other||LS mean difference|0.55|||<|0.001|2-Sided|95.0|0.24|0.86|||Mixed Models Analysis|||Analysis via Mixed Model Repeated Measures (MMRM) with fixed effects for baseline, baseline laxative response, treatment and treatment time interaction. Study pooled center is included as a random effect.|
1675464|NCT01309841|3082254|Superiority or Other||Risk Ratio (RR)|1.691||||0.002|2-Sided|95.0|1.205|2.373||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel||||
1675465|NCT01309841|3082254|Superiority or Other||Risk Ratio (RR)|1.479||||0.028|2-Sided|95.0|1.038|2.107||Response rate over Weeks 1 to 12 in the LIR subgroup is a key secondary endpoint included in the multiple testing procedure.|Cochran-Mantel-Haenszel||||
1675466|NCT01309841|3082255|Superiority or Other||Risk Ratio (RR)|1.509||||0.001|2-Sided|95.0|1.168|1.949|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).|
1675467|NCT01309841|3082255|Superiority or Other||Risk Ratio (RR)|1.38||||0.015|2-Sided|95.0|1.062|1.795|||Cochran-Mantel-Haenszel|||Analysis via Cochran Mantel-Haenszel test stratified by response to laxatives at baseline (LIR, LAR, LUR).|
1675468|NCT01309737|3082304|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1675469|NCT01309737|3082304|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1675470|NCT01309737|3082304|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1675471|NCT01309737|3082305|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1675472|NCT01309737|3082305|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1675473|NCT01309737|3082305|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1675474|NCT01309737|3082306|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1675475|NCT01309737|3082306|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1675476|NCT01309737|3082306|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1675477|NCT01309737|3082310|Superiority or Other||LS Mean Difference|-4.35|Standard Error of the Mean|10.98||0.692|2-Sided|95.0|-25.91|17.21|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.|
1675525|NCT01309360|3082370|Superiority or Other|||||||0.116|||||||Fisher Exact||||
1675478|NCT01309737|3082310|Superiority or Other||LS Mean Difference|-41.79|Standard Error of the Mean|13.75||0.0025|2-Sided|95.0|-68.8|-14.78||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675479|NCT01309737|3082310|Superiority or Other||LS Mean Difference|-37.44|Standard Error of the Mean|13.62||0.0062|2-Sided|95.0|-64.19|-10.68||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675480|NCT01309737|3082311|Superiority or Other||Percent difference|13.62||||0.0002|2-Sided|95.0|6.54|20.69|||Normal Approximation||||
1675481|NCT01309737|3082311|Superiority or Other||Odds Ratio (OR)|17.97|||<|0.0001||95.0|9.0|30.73||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.|
1675482|NCT01309737|3082311|Superiority or Other||Odds Ratio (OR)|9.06|||<|0.0001|2-Sided|95.0|5.02|16.45||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.|
1675483|NCT01309737|3082312|Superiority or Other||Percent Difference|6.72|Standard Error of the Mean|2.26||0.0029|2-Sided|95.0|2.3|11.14|||Normal Approximation||||
1675484|NCT01309737|3082312|Superiority or Other||Odds Ratio (OR)|4.18||||0.0003|2-Sided|95.0|1.77|10.25||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675485|NCT01309737|3082312|Superiority or Other||Odds Ratio (OR)|1.72||||0.1786|2-Sided|95.0|0.74|4.62||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675486|NCT01309737|3082313|Superiority or Other||Percent difference|10.79|Standard Error of the Mean|3.02||0.0004|2-Sided|95.0|4.87|16.71|||Normal Approximation||||
1675487|NCT01309737|3082313|Superiority or Other||Odds Ratio (OR)|8.25|||<|0.0001|2-Sided|95.0|4.08|19.95||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675488|NCT01309737|3082313|Superiority or Other||Odds Ratio (OR)|3.63|||<|0.0001|2-Sided|95.0|1.89|8.95||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675489|NCT01309737|3082314|Superiority or Other||LS Mean Difference|-1.63|Standard Error of the Mean|0.43||0.0002|2-Sided|95.0|-2.48|-0.79|||Mixed Models Analysis|||Week 16: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.|
1675526|NCT01309360|3082370|Superiority or Other|||||||0.116|||||||Fisher Exact||||
1675527|NCT01309360|3082371|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1675528|NCT01309360|3082371|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1675490|NCT01309737|3082314|Superiority or Other||LS Mean Difference|-6.1|Standard Error of the Mean|0.53|<|0.0001|2-Sided|95.0|-7.14|-5.05||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675491|NCT01309737|3082314|Superiority or Other||LS Mean Difference|-4.46|Standard Error of the Mean|0.53|<|0.0001|2-Sided|95.0|-5.51|-3.42||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675492|NCT01309737|3082314|Superiority or Other||LS Mean Difference|-1.33|Standard Error of the Mean|0.35|<|0.0001|2-Sided|95.0|-2.01|-0.65|||Mixed Models Analysis|||Week 4: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.|
1675493|NCT01309737|3082314|Superiority or Other||LS Mean Difference|-4.3|Standard Error of the Mean|0.42|<|0.0001|2-Sided|95.0|-5.13|-3.47||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675494|NCT01309737|3082314|Superiority or Other||LS Mean Difference|-2.97|Standard Error of the Mean|0.42|<|0.0001||95.0|-3.8|-2.14||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675495|NCT01309737|3082316|Superiority or Other||Percent Difference|14.3|Standard Error of the Mean|3.36|<|0.0001|2-Sided|95.0|7.72|20.88|||Normal Approximation||||
1675496|NCT01309737|3082316|Superiority or Other||Odds Ratio (OR)|24.53|||<|0.0001|2-Sided|95.0|8.08|46.22||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675497|NCT01309737|3082316|Superiority or Other||Odds Ratio (OR)|8.5|||<|0.0001||95.0|3.48|17.31||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675498|NCT01309737|3082317|Superiority or Other||LS Mean Difference|-12.36|Standard Error of the Mean|3.0|<|0.0001|2-Sided|95.0|-18.24|-6.48|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.|
1675499|NCT01309737|3082317|Superiority or Other||LS Mean Difference|-58.1|Standard Error of the Mean|3.69|<|0.0001|2-Sided|95.0|-65.33|-50.86||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675529|NCT01309360|3082371|Superiority or Other||||||<|0.247|||||||Wilcoxon (Mann-Whitney)||||
1675530|NCT01309360|3082372|Superiority or Other|||||||0.348|||||||Fisher Exact||||
1675531|NCT01309360|3082372|Superiority or Other|||||||0.087|||||||Fisher Exact||||
1675532|NCT01309360|3082372|Superiority or Other|||||||0.675|||||||Fisher Exact||||
1675533|NCT01309360|3082373|Superiority or Other|||||||0.2|||||||Fisher Exact||||
1675534|NCT01309360|3082373|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1675535|NCT01309360|3082373|Superiority or Other||||||<|0.059|||||||Fisher Exact||||
1675500|NCT01309737|3082317|Superiority or Other||Least Squares (LS) Mean Difference|-45.73|Standard Error of the Mean|3.69|<|0.0001|2-Sided|95.0|-52.98|-38.49||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error.Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1675501|NCT01309737|3082318|Superiority or Other||Percent difference|13.08|Standard Error of the Mean|3.62||0.0003|2-Sided|95.0|5.99|20.17|||Normal approximation||||
1675502|NCT01309737|3082318|Superiority or Other||Odds Ratio (OR)|20.43|||<|0.0001|2-Sided|95.0|8.99|30.59||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.|
1675503|NCT01309737|3082318|Superiority or Other||Odds Ratio (OR)|10.2|||<|0.0001|2-Sided|95.0|5.33|17.68||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.|
1675504|NCT01309659|3082324|Superiority or Other|||||||0.329||||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance in the wait list group. Testing correlation =0.|t-test, 2 sided||||
1675505|NCT01309659|3082324|Superiority or Other|||||||0.624||||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance in the intermediate intervention group. Testing correlation =0.|t-test, 2 sided||||
1675506|NCT01309659|3082325|Superiority or Other|||||||0.396||||||Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance of the wait list group. Testing correlation =0.|t-test, 2 sided||||
1675507|NCT01309659|3082325|Superiority or Other|||||||0.649||||||Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance of the immediate intervention group. Testing correlation =0.|t-test, 2 sided||||
1675508|NCT01309659|3082326|Superiority or Other|||||||0.356||||||Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided||||
1675509|NCT01309659|3082326|Superiority or Other|||||||0.286||||||Correlation between baseline transferrin saturation and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided||||
1675510|NCT01309659|3082326|Superiority or Other|||||||0.732||||||Correlation between baseline iron and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided||||
1675511|NCT01309659|3082326|Superiority or Other|||||||0.383||||||Correlation between baseline iron and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided||||
1675512|NCT01309659|3082326|Superiority or Other|||||||0.798||||||Correlation between baseline serum ferritin and the change in 6 Minute Walk Test distance in the wait list group. Testing correlation =0.|t-test, 2 sided||||
1675513|NCT01309659|3082326|Superiority or Other|||||||0.077||||||Correlation between baseline serum ferritin and the change in 6 Minute Walk Test distance in the immediate intervention group. Testing correlation =0.|t-test, 2 sided||||
1675514|NCT01309659|3082327|Superiority or Other|||||||0.111||||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin in the wait list control group. Testing correlation =0.|t-test, 2 sided||||
1675515|NCT01309659|3082327|Superiority or Other|||||||0.391||||||Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin in the immediate intervention group. Testing correlation =0.|t-test, 2 sided||||
1675516|NCT01309659|3082328|Superiority or Other|||||||0.001||||||Correlation between soluble transfer receptor and change in hemoglobin in the wait list group. Testing the correlation =0.|t-test, 2 sided||||
1675517|NCT01309659|3082328|Superiority or Other|||||||0.649||||||Correlation between soluble transfer receptor and change in hemoglobin in the immediate intervention group. Testing the correlation =0.|t-test, 2 sided||||
1675518|NCT01309659|3082337|Superiority or Other|||||||0.077||||||Correlation between transferrin saturation and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided||||
1675519|NCT01309659|3082337|Superiority or Other|||||||0.606||||||Correlation between transferrin saturation and change in hemoglobin in the immediate intervention group. Testing the correlation = 0.|t-test, 2 sided||||
1675520|NCT01309659|3082337|Superiority or Other|||||||0.106||||||Correlation between iron and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided||||
1675521|NCT01309659|3082337|Superiority or Other|||||||0.396||||||Correlation between iron and change in hemoglobin in the intermediate intervention group. Testing the correlation = 0.|t-test, 2 sided||||
1675522|NCT01309659|3082337|Superiority or Other|||||||0.601||||||Correlation between ferritin and change in hemoglobin in the waitlist group. Testing the correlation = 0.|t-test, 2 sided||||
1675536|NCT01309360|3082374|Superiority or Other|||||||0|||||||Kruskal-Wallis||||
1675549|NCT01309243|3082397|Superiority or Other||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA||||
1675550|NCT01309243|3082398|Superiority or Other||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA||||
1675551|NCT01309243|3082399|Superiority or Other||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA||||
1675552|NCT01309243|3082400|Superiority or Other||||||<|0.001||||||P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.|ANOVA||||
1675553|NCT01309243|3082401|Superiority or Other||Difference in LSM|20.0||||0.17|2-Sided|95.0|-9.0|49.0||The p-value, and difference in LSM and its 95% CI are from ANOVA with treatment and baseline HIV-1 RNA levels (≤ 100,000, > 100,000 copies/mL) as fixed effect.|ANOVA||||
1675554|NCT01309243|3082402|Superiority or Other||Difference in LSM|11.0||||0.34|2-Sided|95.0|-11.0|32.0||The p-value, and difference in least square means (LSM) and its 95% CI are from analysis of variance (ANOVA) with treatment and baseline HIV-1 RNA levels (≤ 100,000, > 100,000 copies/mL) as fixed effect.|ANOVA||||
1675555|NCT01309243|3082403|Superiority or Other||Difference in the response rates|5.5|||||2-Sided|95.0|-0.6|11.5|||||The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and > 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.||
1675556|NCT01309243|3082404|Non-Inferiority or Equivalence|"Null hypothesis: The FTC/RPV/TDF group was at least 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA < 50 copies/mL (“response rate,” as defined by the snapshot analysis algorithm) at Week 48.~Alternative hypothesis: The FTC/RPV/TDF group was less than 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA < 50 copies/mL at Week 48."|Difference in the response rates|4.1|||||2-Sided|95.0|-1.1|9.2|||||The baseline stratum-weighted (HIV-1 RNA ≤ 100,000 and > 100,000 copies/mL) difference in virologic success rates and its 95% CI were from baseline HIV-1 RNA adjusted Mantel-Haenszel proportions.|"The analysis was to assess the noninferiority of FTC/RPV/TDF versus EFV/FTC/TDF using a 95% confidence interval (CI) approach, with a noninferiority margin of 12% (lower bound of CI > -12%).~700 subjects allocated 1:1 to either treatment arm was predicted to give > 95% power when the proportion of responders in both treatment groups for the primary endpoint is 80% at Week 48."|
1675557|NCT01308788|3082432|Superiority or Other|||||||0.7965|||||||ANCOVA||||
1675558|NCT01308788|3082433|Superiority or Other|||||||0.6896|||||||ANCOVA||||
1675559|NCT01308788|3082434|Superiority or Other|||||||0.25|||||||ANCOVA||||
1675560|NCT01308788|3082435|Superiority or Other|||||||0.0684|||||||ANCOVA||||
1675561|NCT01308788|3082436|Superiority or Other|||||||0.5431|||||||ANCOVA||||
1675562|NCT01308788|3082437|Superiority or Other|||||||0.1331|||||||ANCOVA||||
1675563|NCT01308788|3082438|Superiority or Other|||||||0.7847|||||||ANCOVA||||
1675564|NCT01308788|3082439|Superiority or Other|||||||0.5443|||||||ANCOVA||||
1675565|NCT01308788|3082440|Superiority or Other|||||||0.6156|||||||ANCOVA||||
1675566|NCT01308788|3082441|Superiority or Other|||||||0.5058|||||||ANCOVA||||
1675567|NCT01308788|3082442|Superiority or Other|||||||0.293|||||||ANCOVA||||
1675568|NCT01308788|3082443|Superiority or Other|||||||0.5496|||||||ANCOVA||||
1675569|NCT01308788|3082444|Superiority or Other|||||||0.782|||||||ANCOVA||||
1675570|NCT01308788|3082445|Superiority or Other|||||||0.4414|||||||ANCOVA||||
1675571|NCT01308749|3082452|Equivalence|t-test between groups||||||0.23|||||||t-test, 2 sided|no adjustment for multiple comparison. non parametric|||
1675572|NCT01308749|3082454|Equivalence|Within group test of difference using t-scores adjusted by baseline score, no correction for multiple comparisons, nonparametric model||||||0.023|||||||t-test, 2 sided||||
1675573|NCT01308749|3082458|Other||||||||||||||||||No analyses were completed, this is descriptive only and is an absolute value (number of participants).
1675574|NCT01308580|3082475|Superiority or Other||Hazard Ratio (HR)|1.046|||||2-Sided|95.0|0.874|1.251|||||Cabazitaxel 20 mg/m^2 vs Cabazitaxel 25 mg/m^2|Hazard ratio is estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.|
1675575|NCT01308580|3082477|Superiority or Other||Hazard Ratio (HR)|1.195|||||2-Sided|95.0|1.025|1.393|||||Cabazitaxel 20 mg/m^2 vs Cabazitaxel 25 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.|
1675576|NCT01308580|3082479|Superiority or Other||Hazard Ratio (HR)|1.096|||||2-Sided|95.0|0.902|1.331|||||Cabazitaxel 20 mg/m^2 vs Cabazitaxel 25 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.|
1675577|NCT01308580|3082480|Superiority or Other||Hazard Ratio (HR)|1.099|||||2-Sided|95.0|0.974|1.24|||||Cabazitaxel 20 mg/m^2 vs Cabazitaxel 25 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization.|
1675578|NCT01308580|3082481|Superiority or Other||Hazard Ratio (HR)|1.024|||||1-Sided|95.0|0.922||||||Cabazitaxel 20 mg/m^2 vs Cabazitaxel 25 mg/m^2|The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 25 mg/m^2 was considered to be superior to 20 mg/m^2 dose if the lower bound of 1-sided 95% confidence interval of hazard ratio was greater than 1.|
1675597|NCT01307787|3082529|Superiority or Other|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.|
1675638|NCT01307423|3082606|Superiority or Other (legacy)||Risk Difference (RD)|7.1|||||2-Sided|95.0|-7.2|21.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675579|NCT01308580|3082481|Non-Inferiority or Equivalence|Non-inferiority margin of 1.214|Hazard Ratio (HR)|1.024|||||1-Sided|98.89||1.184|||||Cabazitaxel 20 mg/m^2 vs Cabazitaxel 25 mg/m^2|The hazard ratio for OS was estimated using the Cox proportional hazards regression model. The Cox proportional hazard model was adjusted by measurability of the disease at baseline, ECOG PS score at baseline, and region at the time of randomization. Cabazitaxel 20 mg/m^2 relative to 25 mg/m^2 dose group was considered non-inferior if the upper bound of 1-sided 98.89% confidence interval of hazard ratio (20 mg/m^2 versus 25 mg/m^2) was less than the non-inferiority margin of 1.214.|
1675580|NCT01308567|3082484|Superiority or Other||Hazard Ratio (HR)|1.014|||||2-Sided|95.0|0.798|1.288|||||Cabazitaxel 20 mg/m^2 vs Docetaxel 75 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.|
1675581|NCT01308567|3082484|Superiority or Other||Hazard Ratio (HR)|1.121|||||2-Sided|95.0|0.886|1.417|||||Cabazitaxel 25 mg/m^2 vs Docetaxel 75 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.|
1675582|NCT01308567|3082486|Superiority or Other||Hazard Ratio (HR)|1.189|||||2-Sided|95.0|0.985|1.435|||||Cabazitaxel 20 mg/m^2 vs Docetaxel 75 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.|
1675583|NCT01308567|3082486|Superiority or Other||Hazard Ratio (HR)|1.189|||||2-Sided|95.0|0.986|1.434|||||Cabazitaxel 25 mg/m^2 vs Docetaxel 75 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.|
1675584|NCT01308567|3082488|Superiority or Other||Hazard Ratio (HR)|1.047|||||2-Sided|95.0|0.886|1.238|||||Cabazitaxel 20 mg/m^2 vs Docetaxel 75 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.|
1675585|NCT01308567|3082488|Superiority or Other||Hazard Ratio (HR)|0.948|||||2-Sided|95.0|0.8|1.123|||||Cabazitaxel 25 mg/m^2 vs Docetaxel 75 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.|
1675586|NCT01308567|3082490|Superiority or Other||Hazard Ratio (HR)|0.916|||||2-Sided|95.0|0.75|1.118|||||Cabazitaxel 20 mg/m^2 vs Docetaxel 75 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.|
1675587|NCT01308567|3082490|Superiority or Other||Hazard Ratio (HR)|0.958|||||2-Sided|95.0|0.785|1.17|||||Cabazitaxel 25 mg/m^2 vs Docetaxel 75 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.|
1675588|NCT01308567|3082491|Superiority or Other||Hazard Ratio (HR)|1.063|||||2-Sided|95.0|0.913|1.236|||||Cabazitaxel 20 mg/m^2 vs Docetaxel 75 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.|
1675589|NCT01308567|3082491|Superiority or Other||Hazard Ratio (HR)|0.989|||||2-Sided|95.0|0.849|1.152|||||Cabazitaxel 25 mg/m^2 vs Docetaxel 75 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.|
1675590|NCT01308567|3082492|Superiority or Other||Hazard Ratio (HR)|1.009||||0.9967|2-Sided|95.0|0.85|1.197||P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479|Log Rank||Cabazitaxel 20 mg/m^2 vs Docetaxel 75 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by ECOG PS score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.|
1675591|NCT01308567|3082492|Superiority or Other||Hazard Ratio (HR)|0.975||||0.7574|2-Sided|95.0|0.819|1.16||P-value from two-sided stratified log-rank test, stratified for ECOG PS score at baseline, measurable disease at baseline and region with commercial availability of cabazitaxel at time of randomization. Threshold for statistical significance = 0.0479|Log Rank||Cabazitaxel 25 mg/m^2 vs Docetaxel 75 mg/m^2|Hazard ratio was estimated using a Cox Proportional Hazards regression model. The Cox proportional hazard model was adjusted by Eastern Cooperative Oncology Group performance status (ECOG PS) score at baseline, measurable disease at baseline, and region with commercial availability of cabazitaxel at the time of randomization.|
1675592|NCT01308008|3082516|Superiority||coefficient|-8.7||||0.5|2-Sided|95.0|-35.0|17.0|||Regression, Logistic||||
1675593|NCT01308008|3082517|Superiority||coefficient|34.0||||0.17|2-Sided|95.0|-15.0|83.0|||Regression, Logistic||||
1675594|NCT01308008|3082518|Superiority||coefficient|0.05||||0.16|2-Sided|95.0|-0.02|0.13|||Regression, Logistic||||
1675595|NCT01307787|3082527|Superiority or Other|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.|
1675596|NCT01307787|3082528|Superiority or Other|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.|
1675708|NCT01307033|3082709|Superiority or Other||Difference in least squares means|-2.3|||||2-Sided|95.0|-5.0|0.5|||||||
1675598|NCT01307787|3082530|Superiority or Other|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.|
1675599|NCT01307787|3082531|Superiority or Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.|
1675600|NCT01307787|3082532|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.|
1675601|NCT01307787|3082533|Superiority or Other|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.|
1675602|NCT01307787|3082534|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U tests were used to assess between group changes on delta scores at times T0( at the start of the study in week 1) and T1( post-intervention in week 9). Significance level for all statistical tests was set at p< 0.05.|
1675603|NCT01307748|3082535|Other|||||||0.01||||||P value was adjusted for multiple comparisons using false discovery rate|ANCOVA|A 3 (lavender, coconut, water) by 2 ( prime, no prime) Analysis of Covariance (ANCOVA), with years of education as a covariate was used.|||
1675604|NCT01307748|3082537|Other|||||||0.005||||||The p value was adjusted for multiple comparisons using false discovery rate.|ANCOVA|Repeated-measures ANOVA with time (stress, post-stress) as a within factor and aroma (lavender, coconut, water) as a between-group factor was used.||The null hypothesis stated that there were no differences between the groups in cortisol level trajectory over time.|
1675605|NCT01307462|3082569|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Lee symptom overall summary scale|
1675606|NCT01307462|3082569|Superiority||||||<|0.002|||||||Wilcoxon (Mann-Whitney)|||Lee symptom mouth scale|
1675607|NCT01307462|3082569|Superiority||||||<|0.22|||||||Wilcoxon (Mann-Whitney)|||Lee symptom psychological scale|
1675608|NCT01307462|3082569|Superiority||||||<|0.52|||||||Wilcoxon (Mann-Whitney)|||Lee symptom nutrition scale|
1675609|NCT01307462|3082569|Superiority||||||<|0.002|||||||Wilcoxon (Mann-Whitney)|||Lee symptom eye scale|
1675610|NCT01307462|3082569|Superiority||||||<|0.2|||||||Wilcoxon (Mann-Whitney)|||Lee symptom lung scale|
1675611|NCT01307462|3082569|Superiority||||||<|0.007|||||||Wilcoxon (Mann-Whitney)|||Lee symptom energy scale|
1675612|NCT01307462|3082569|Superiority||||||<|0.11|||||||Wilcoxon (Mann-Whitney)|||Lee symptom skin scale|
1675613|NCT01307462|3082570|Superiority|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Modified HAP adjusted activity score|
1675614|NCT01307462|3082570|Superiority|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||HAP adjusted activity score - MAS minus stopped|
1675615|NCT01307462|3082570|Superiority|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||HAP maximum activity score - highest item still doing|
1675616|NCT01307462|3082571|Superiority|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||FACT-BMT total|
1675617|NCT01307462|3082571|Superiority|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||FACT-G|
1675618|NCT01307462|3082571|Superiority|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||FACT trial outcome index|
1675619|NCT01307462|3082571|Superiority|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||FACT BMT subscale|
1675620|NCT01307462|3082571|Superiority|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||FACT functional well-being|
1675621|NCT01307462|3082571|Superiority|||||||0.63|||||||Wilcoxon (Mann-Whitney)|||FACT emotional well-being|
1675622|NCT01307462|3082571|Superiority|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||FACT social/family well-being|
1675623|NCT01307462|3082571|Superiority|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||FACT physical well-being|
1675624|NCT01307462|3082572|Superiority|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||SF-36 standardized mental component score|
1675625|NCT01307462|3082572|Superiority|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||SF-36 standardized physical component score|
1675626|NCT01307462|3082572|Superiority|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based mental health score|
1675627|NCT01307462|3082572|Superiority|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based role-emotional score|
1675628|NCT01307462|3082572|Superiority|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based social functioning score|
1675629|NCT01307462|3082572|Superiority|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based vitality score|
1675630|NCT01307462|3082572|Superiority|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based general health score|
1675631|NCT01307462|3082572|Superiority|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based bodily pain score|
1675632|NCT01307462|3082572|Superiority|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based role-physical score|
1675633|NCT01307462|3082572|Superiority|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||SF-36 norm-based physical functioning score|
1675634|NCT01307423|3082604|Superiority or Other (legacy)||Risk Difference (RD)|4.9|||||2-Sided|95.0|-9.5|19.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675635|NCT01307423|3082604|Superiority or Other (legacy)||Risk Difference (RD)|10.5|||||2-Sided|95.0|-3.8|24.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675636|NCT01307423|3082605|Superiority or Other (legacy)||Risk Difference (RD)|15.2|||||2-Sided|95.0|3.4|27.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675637|NCT01307423|3082605|Superiority or Other (legacy)||Risk Difference (RD)|6.5|||||2-Sided|95.0|-4.8|17.7|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675709|NCT01307033|3082710|Superiority or Other||Difference in least squares means|0.2|||||2-Sided|95.0|-1.7|2.2|||||||
1675639|NCT01307423|3082606|Superiority or Other (legacy)||Risk Difference (RD)|9.4|||||2-Sided|95.0|-4.8|23.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675640|NCT01307423|3082607|Superiority or Other (legacy)||Risk Difference (RD)|17.8|||||2-Sided|95.0|6.3|29.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675641|NCT01307423|3082607|Superiority or Other (legacy)||Risk Difference (RD)|2.2|||||2-Sided|95.0|-8.1|12.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675642|NCT01307423|3082608|Superiority or Other (legacy)||Risk Difference (RD)|0.6|||||2-Sided|95.0|-3.7|4.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675643|NCT01307423|3082608|Superiority or Other (legacy)||Risk Difference (RD)|0.0|||||2-Sided|95.0|-4.1|4.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675644|NCT01307423|3082609|Superiority or Other (legacy)||Risk Difference (RD)|6.3|||||2-Sided|95.0|0.2|12.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution||
1675645|NCT01307423|3082609|Superiority or Other (legacy)||Risk Difference (RD)|9.8|||||2-Sided|95.0|3.2|16.3|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution||
1675646|NCT01307423|3082610|Superiority or Other (legacy)||Risk Difference (RD)|2.8|||||2-Sided|95.0|-0.4|6.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution||
1675647|NCT01307423|3082610|Superiority or Other (legacy)||Risk Difference (RD)|2.9|||||2-Sided|95.0|-0.4|6.2|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution||
1675648|NCT01307423|3082611|Superiority or Other (legacy)||Risk Difference (RD)|6.8|||||2-Sided|95.0|1.2|12.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675649|NCT01307423|3082611|Superiority or Other (legacy)||Risk Difference (RD)|6.9|||||2-Sided|95.0|1.3|12.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675650|NCT01307423|3082612|Superiority or Other (legacy)||Risk Difference (RD)|11.4|||||2-Sided|95.0|2.7|20.0|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675651|NCT01307423|3082612|Superiority or Other (legacy)||Risk Difference (RD)|17.8|||||2-Sided|95.0|8.8|26.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675652|NCT01307423|3082613|Superiority or Other (legacy)||Risk Difference (RD)|5.3|||||2-Sided|95.0|-9.2|19.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675653|NCT01307423|3082613|Superiority or Other (legacy)||Risk Difference (RD)|11.9|||||2-Sided|95.0|-2.1|25.9|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675654|NCT01307423|3082614|Superiority or Other (legacy)||Risk Difference (RD)|18.0|||||2-Sided|95.0|5.3|30.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution||
1675655|NCT01307423|3082614|Superiority or Other (legacy)||Risk Difference (RD)|6.0|||||2-Sided|95.0|-6.8|18.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution||
1675656|NCT01307423|3082615|Superiority or Other (legacy)||Risk Difference (RD)|19.3|||||2-Sided|95.0|9.6|29.1|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675657|NCT01307423|3082615|Superiority or Other (legacy)||Risk Difference (RD)|16.1|||||2-Sided|95.0|6.4|25.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675658|NCT01307423|3082616|Superiority or Other (legacy)||Risk Difference (RD)|1.9|||||2-Sided|95.0|-12.6|16.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675659|NCT01307423|3082616|Superiority or Other (legacy)||Risk Difference (RD)|6.3|||||2-Sided|95.0|-7.8|20.4|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675660|NCT01307423|3082617|Superiority or Other (legacy)||Risk Difference (RD)|17.0|||||2-Sided|95.0|4.2|29.8|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution||
1675661|NCT01307423|3082617|Superiority or Other (legacy)||Risk Difference (RD)|2.6|||||2-Sided|95.0|-10.2|15.5|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution||
1675662|NCT01307423|3082618|Superiority or Other (legacy)||LS Mean difference|2.33|||||2-Sided|95.0|0.52|4.15|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1675663|NCT01307423|3082618|Superiority or Other (legacy)||LS Mean Difference|1.12|||||2-Sided|95.0|-0.68|2.93|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1675664|NCT01307423|3082619|Superiority or Other (legacy)||LS Mean Difference|-0.46||||0.0001|2-Sided|95.0|-0.69|-0.22|||ANCOVA||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1675665|NCT01307423|3082619|Superiority or Other (legacy)||LS Mean Difference|-0.47|||<|0.0001|2-Sided|95.0|-0.7|-0.23|||ANCOVA||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1675666|NCT01307423|3082620|Superiority or Other (legacy)||LS Mean Difference|-5.14|||||2-Sided|95.0|-7.38|-2.89|||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1675667|NCT01307423|3082620|Superiority or Other (legacy)||LS Mean Difference|-5.07|||||2-Sided|95.0|-7.31|-2.84|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1675710|NCT01306877|3082741|Superiority or Other|||||||0.9062|||||||Wilcoxon (Mann-Whitney)||||
1675668|NCT01307423|3082621|Superiority or Other (legacy)||LS Mean Difference|-0.6|||||2-Sided|95.0|-1.4|0.1|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1675669|NCT01307423|3082621|Superiority or Other (legacy)||LS Mean Difference|-1.0|||||2-Sided|95.0|-1.7|-0.3|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1675670|NCT01307423|3082622|Superiority or Other (legacy)||LS Mean Difference|-0.9|||||2-Sided|95.0|-1.6|-0.2|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1675671|NCT01307423|3082622|Superiority or Other (legacy)||LS Mean Difference|-0.3|||||2-Sided|95.0|-1.0|0.4|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1675672|NCT01307423|3082623|Superiority or Other (legacy)||LS Mean Difference|-5.7|||||2-Sided|95.0|-10.8|-0.7|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate||
1675673|NCT01307423|3082623|Superiority or Other (legacy)||LS Mean Difference|-5.6|||||2-Sided|95.0|-10.6|-0.5|||||Based on an analysis of covariance (Ancova) model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate||
1675674|NCT01307423|3082624|Superiority or Other (legacy)||Risk Difference (RD)|18.2|||||2-Sided|95.0|9.2|27.2|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution||
1675675|NCT01307423|3082624|Superiority or Other (legacy)||Risk Difference (RD)|19.5|||||2-Sided|95.0|10.5|28.6|||||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution||
1675676|NCT01307423|3082625|Superiority or Other (legacy)||LS Mean Difference|3.72|||||2-Sided|95.0|2.02|5.41|||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate||
1675677|NCT01307423|3082625|Superiority or Other (legacy)||LS Means Difference|1.97|||||2-Sided|95.0|0.28|3.65|||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate||
1675678|NCT01307423|3082626|Superiority or Other (legacy)||Difference in LS Means|2.55|||||2-Sided|95.0|0.8|4.31|||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1675679|NCT01307423|3082626|Superiority or Other (legacy)||Difference in LS Means|1.12|||||2-Sided|95.0|-0.63|2.87|||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1675680|NCT01307423|3082627|Superiority or Other (legacy)||LS Mean Difference|-0.53|||<|0.0001|2-Sided|95.0|-0.74|-0.32|||ANCOVA||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1675681|NCT01307423|3082627|Superiority or Other (legacy)||LS Mean Difference|-0.46|||<|0.0001|2-Sided|95.0|-0.67|-0.25|||ANCOVA||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1675682|NCT01307423|3082628|Superiority or Other (legacy)||LS Mean Difference|-5.65|||||2-Sided|95.0|-7.78|-3.51|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1675683|NCT01307423|3082628|Superiority or Other (legacy)||LS Mean Difference|-4.91|||||2-Sided|95.0|-7.04|-2.78|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1675684|NCT01307423|3082629|Superiority or Other (legacy)||LS Mean Difference|-0.7|||||2-Sided|95.0|-1.4|0.0|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1675685|NCT01307423|3082629|Superiority or Other (legacy)||LS Mean Difference|-0.9|||||2-Sided|95.0|-1.6|-0.2|||||Based on analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1675686|NCT01307423|3082630|Superiority or Other (legacy)||LS Mean Difference|-1.0||||0.0038|2-Sided|95.0|-1.7|-0.3||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1675687|NCT01307423|3082630|Superiority or Other (legacy)||LS Mean Difference|-0.1||||0.7696|2-Sided|95.0|-0.8|0.6|||ANCOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1675688|NCT01307423|3082631|Superiority or Other (legacy)||LS Mean Difference|-7.8||||0.0022|2-Sided|95.0|-12.8|-2.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate|||
1675689|NCT01307423|3082631|Superiority or Other (legacy)||LS Mean Difference|-5.0||||0.0485|2-Sided|95.0|-10.0|0.0||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate|||
1675690|NCT01307423|3082632|Superiority or Other (legacy)||Risk Difference (RD)|21.0|||<|0.0001|2-Sided|95.0|11.3|30.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675691|NCT01307423|3082632|Superiority or Other (legacy)||Risk Difference (RD)|14.4|||<|0.0037|2-Sided|95.0|4.8|24.0||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675692|NCT01307423|3082633|Superiority or Other (legacy)||LS Mean Difference|3.18||||0.0002|2-Sided|95.0|1.55|4.82||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and baseline value as a covariate|||
1675693|NCT01307423|3082633|Superiority or Other (legacy)||LS Mean Difference|2.38||||0.0043|2-Sided|95.0|0.75|4.01||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and baseline value as a covariate|||
1675694|NCT01307423|3082634|Superiority or Other (legacy)||LS Mean Difference|-0.219|||<|0.0001|2-Sided|95.0|-0.322|-0.117||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and baseline value as a covariate|||
1675695|NCT01307423|3082634|Superiority or Other (legacy)||LS Mean Difference|-0.168|||<|0.0014|2-Sided|95.0|-0.271|-0.065||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|ANCOVA|Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and baseline value as a covariate|||
1675696|NCT01307423|3082635|Superiority or Other (legacy)||Risk Difference (RD)|11.4||||0.0063|2-Sided|95.0|3.3|19.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675697|NCT01307423|3082635|Superiority or Other (legacy)||Risk Difference (RD)|16.1||||0.0002|2-Sided|95.0|7.7|24.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.||
1675698|NCT01307423|3082636|Superiority or Other (legacy)||LS Mean Difference|-0.217|||<|0.0001|2-Sided|95.0|-0.314|-0.12|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.|
1675699|NCT01307423|3082636|Superiority or Other (legacy)||LS Mean Difference|-0.168|||<|0.0008|2-Sided|95.0|-0.265|-0.071|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group as a factor, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.|
1675700|NCT01307423|3082637|Superiority or Other (legacy)||Risk Difference (RD)|14.8||||0.001|2-Sided|95.0|6.1|23.5|||Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.|
1675701|NCT01307423|3082637|Superiority or Other (legacy)||Risk Difference (RD)|12.1||||0.0062|2-Sided|95.0|3.5|20.7|||Chi-squared||Two-sided 95% CI of the proportion difference is based on the normal approximation to the binomial distribution.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.|
1675702|NCT01307319|3082654|Superiority or Other||LSM treatment difference from placebo|-0.76|||<|0.001|2-Sided|95.0|-1.1|-0.4||a priori statistical significance is <0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.|||
1675703|NCT01307319|3082654|Superiority or Other||LSM treatment difference from placebo|-0.71|||<|0.001|2-Sided|95.0|-1.1|-0.3||a priori statistical significance is <0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||The power calculation assumed the standard deviation (SD) for the change from baseline over two weeks in the average of AM and PM reflective TNSS is assumed to be 2.0. Using this standard deviation, 235 subjects per arm provides 90% power to detect a difference of 0.60 in TNSS change from baseline between treatment groups with a two-sided alpha level of 0.05.|
1675704|NCT01307319|3082655|Superiority or Other||LSM treatment difference from placebo|-0.73|||<|0.001|2-Sided|95.0|-1.1|-0.4||a priori statistical significance is <0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.|||
1675705|NCT01307319|3082655|Superiority or Other||LSM treatment difference from placebo|-0.63|||<|0.001|2-Sided|95.0|-1.0|-0.3||a priori statistical significance is <0.05.|mixed-model for repeated measures (MMRM)|The MMRM included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.|||
1675706|NCT01307046|3082706|Superiority or Other||Difference in least square means|-9.2|||<|0.001|2-Sided|95.0|-11.9|-6.5|||constrained longitudinal data analysis||||
1675707|NCT01307046|3082707|Superiority or Other||Difference in least square means|-5.1|||<|0.001|2-Sided|95.0|-6.8|-3.4|||constrained longitudinal data analysis||||
1675711|NCT01306877|3082742|Superiority or Other|||||||0.5647|||||||Wilcoxon (Mann-Whitney)||||
1675713|NCT01306877|3082747|Non-Inferiority or Equivalence|The objective is to reject H0 at the 0.05 significance level. A one-sided 95% confidence upper limit for PC - PE will be constructed by Newcombe’s generalized Wilson score method (Newcombe 1998). H0 will be rejected at the 0.05 significance level if this upper limit is <7%.|Risk Difference (RD)|-0.314||||0.0001|1-Sided|95.0||-0.18||P-value calculated from per protocol analysis set|Chi-squared||||
1675714|NCT01306617|3082763|Superiority or Other|||||||0.048|||||||Log Rank||||
1675715|NCT01306617|3082764|Superiority or Other|||||||0.01|||||||Log Rank||||
1675716|NCT01306617|3082764|Superiority or Other|||||||0.395|||||||Log Rank||||
1675717|NCT01306617|3082765|Superiority or Other|||||||0.012|||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (<=800,000, >800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.|||
1675718|NCT01306617|3082765|Superiority or Other|||||||0.312|||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (<=800,000, >800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.|||
1675719|NCT01306617|3082766|Superiority or Other|||||||0.012|||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (<=800,000, >800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.|||
1675720|NCT01306617|3082766|Superiority or Other|||||||0.312|||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (<=800,000, >800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.|||
1675721|NCT01306617|3082767|Superiority or Other|||||||0.375|||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (<=800,000, >800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.|||
1675722|NCT01306617|3082767|Superiority or Other|||||||0.061|||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (<=800,000, >800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.|||
1675723|NCT01306617|3082768|Superiority or Other|||||||0.061|||||||Cochran-Mantel-Haenszel|Arm, baseline log10 HCV RNA level (<=800,000, >800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.|||
1675724|NCT01306617|3082769|Superiority or Other|||||||0.207|||||||Regression, Logistic|Arm, baseline log10 HCV RNA level (<=800,000, >800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.|||
1675725|NCT01306617|3082769|Superiority or Other|||||||0.547|||||||Regression, Logistic|Arm, baseline log10 HCV RNA level (<=800,000, >800,000), IL-28B genotype (CC, non-CC), and HCV subgenotype (1a, 1b) were used as strata.||For the percentage of subjects with HCV RNA suppressed below the LLOD from Week 4 through Week 12, if it was assumed that 60% of subjects would be successfully suppressed from Week 4 through Week 12, then 20 subjects in arm 1 would give a 95% 2-sided confidence interval (CI) of (38.5%, 81.5%), 10 subjects in arm 2 would give a 95% CI of (29.6%, 90.4%), and 15 subjects in arm 3 would give a 95% CI of (35.2%, 84.8%) for the percentage of subjects suppressed using the binomial exact method.|
1675726|NCT01306214|3082783|Superiority or Other||Adjusted mean difference|-0.46|Standard Error of the Mean|0.11|<|0.0001|2-Sided|97.5|-0.7|-0.22||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 25 mg and placebo Ha : A difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 25 mg and placebo"|
1675727|NCT01306214|3082783|Non-Inferiority or Equivalence|The non- inferiority margin was 0.3%, one-sided.|Adjusted mean difference|-0.46|Standard Error of the Mean|0.11|<|0.0001|2-Sided|97.5|-0.7|-0.22||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|H013: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 25 mg and placebo >0.3 Ha13: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 25 mg and placebo ≤0.3|
1675728|NCT01306214|3082783|Superiority or Other||Adjusted mean difference|-0.38|Standard Error of the Mean|0.11|<|0.0005|2-Sided|97.5|-0.62|-0.13||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 10 mg and placebo Ha : A difference in change from baseline to Week 52 in HbA1c (%) between Empagliflozin 10 mg and placebo"|
1675729|NCT01306214|3082783|Non-Inferiority or Equivalence|The non- inferiority margin was 0.3%, one-sided.|Adjusted mean difference|-0.38|Standard Error of the Mean|0.11|<|0.0001|2-Sided|97.5|-0.62|-0.13||Hierarchical testing adjusted for multiple comparisons within each dose, alpha split between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 52 was the 4th step (non-inferiority) and 5th step (superiority).|ANCOVA|Model includes baseline HbA1c as covariate and baseline eGFR, geographical region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|H0: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 10 mg and placebo >0.3 Ha: Difference in change from baseline to Week 52 in HbA1c (%) between empagliflozin 10 mg and placebo ≤0.3|
1675740|NCT01306162|3082794|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|159.0|Standard Deviation|21.5||0.8875|2-Sided|90.0|114.0|222.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)|
1675843|NCT01302834|3083133|Superiority||Hazard Ratio (HR)|1.72||||0.0002|2-Sided|95.0|1.29|2.29|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT + Cisplatin||
1675730|NCT01306214|3082784|Superiority or Other||Adjusted mean difference|-2.48|Standard Error of the Mean|0.51|<|0.0001|2-Sided|97.5|-3.63|-1.33||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in body weight at week 52 was the third step in hierarchical sequence.|ANCOVA|Model includes baseline weight, baseline HbA1c as covariates and baseline eGFR, region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 25 mg - Adjusted mean of placebo|hypothesis test: H0: No difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 25 mg and placebo Ha: A difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 25 mg and placebo|
1675731|NCT01306214|3082784|Superiority or Other||Adjusted mean difference|-2.39|Standard Error of the Mean|0.51|<|0.0001|2-Sided|97.5|-3.54|-1.24||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in body weight at week 52 was the third step in hierarchical sequence.|ANCOVA|Model includes baseline weight, baseline HbA1c as covariates and baseline eGFR, region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 10 mg and placebo Ha : A difference in change from baseline to Week 52 in body weight (kg) between Empagliflozin 10 mg and placebo"|
1675732|NCT01306214|3082785|Superiority or Other||Adjusted mean difference|-11.22|Standard Error of the Mean|3.05||0.0003|2-Sided|97.5|-18.09|-4.36||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in insulin dose at week 52 was the second step in hierarchical sequence.|ANCOVA|Model - Covariates: baseline insulin daily dose,baseline HbA1c Fixed effects: baseline eGFR, region, baseline background medication, treatment|Estimated value = Adjusted mean of Empagliflozin 25 mg - Adjusted mean of placebo.|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 25 mg and placebo Ha : A difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 25 mg and placebo"|
1675733|NCT01306214|3082785|Superiority or Other||Adjusted mean difference|-8.83|Standard Error of the Mean|3.05||0.004|2-Sided|97.5|-15.69|-1.97||Hierarchical testing adjusted for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in insulin dose at week 52 was the second step in hierarchical sequence.|ANCOVA|Model - Covariates: baseline insulin daily dose,baseline HbA1c Fixed effects: baseline eGFR, region, baseline background medication, treatment|Estimated value = Adjusted mean of empagliflozin 10 mg - Adjusted mean of placebo|"Hypothesis test:~H0: No difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 10 mg and placebo Ha: A difference in change from baseline to Week 52 in insulin dose (IU/day) between Empagliflozin 10 mg and placebo"|
1675734|NCT01306214|3082786|Superiority or Other||Adjusted mean difference|-0.52|Standard Error of the Mean|0.07|<|0.0001|2-Sided|97.5|-0.69|-0.35||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 18 was the first step in each hierarchical sequence.|ANCOVA|ANCOVA Model includes baseline HbA1c as a covariate and baseline eGFR, geographic region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of Empagliflozin 25 mg - Adjusted mean of placebo|"For the primary endpoint, the testing of the superiority hypothesis versus placebo was:~H0: No difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 25 mg and placebo Ha: A difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 25 mg and placebo"|
1675735|NCT01306214|3082786|Superiority or Other||Adjusted mean difference|-0.44|Standard Error of the Mean|0.08|<|0.0001|2-Sided|97.5|-0.61|-0.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empagliflozin versus placebo change from baseline in HbA1c at week 18 was the first step in each hierarchical sequence.|ANCOVA|ANCOVA Model includes baseline HbA1c as a covariate and baseline eGFR, geographic region, baseline background medication, treatment as fixed effects.|Estimated value = Adjusted mean of Empagliflozin 10 mg - Adjusted mean of placebo.|"For the primary endpoint, the testing of the superiority hypothesis versus placebo was:~Hypothesis test:~H0: No difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 10 mg and placebo Ha: A difference in change from baseline to Week 18 in HbA1c (%) between Empagliflozin 10 mg and placebo"|
1675736|NCT01306162|3082793|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|126.0|Standard Deviation|22.6||0.5164|2-Sided|90.0|89.0|179.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)|
1675737|NCT01306162|3082793|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|234.0|Standard Deviation|26.7||0.9958||90.0|160.0|340.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)|
1675738|NCT01306162|3082793|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|114.0|Standard Deviation|29.4||0.1866|2-Sided|90.0|95.0|136.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)|
1675739|NCT01306162|3082793|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|180.0|Standard Deviation|24.6||0.9998|2-Sided|90.0|156.0|207.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)|
1675764|NCT01305577|3082842|Superiority or Other||LS Mean Difference|1.41|||<|0.001|2-Sided|95.0|0.99|1.84|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.|||
1676033|NCT01301079|3083418|Superiority or Other|||||||0.946|||||||t-test, 2 sided||||
1675741|NCT01306162|3082794|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|258.0|Standard Deviation|24.6||0.9993||90.0|182.0|365.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)|
1675742|NCT01306162|3082794|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|132.0|Standard Deviation|26.3||0.7223|2-Sided|90.0|113.0|155.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)|
1675743|NCT01306162|3082794|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|214.0|Standard Deviation|20.7||1|2-Sided|90.0|190.0|241.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)|
1675744|NCT01306162|3082795|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|133.0|Standard Deviation|23.0||0.6221|2-Sided|90.0|94.0|190.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)|
1675745|NCT01306162|3082795|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|225.0|Standard Deviation|26.1||0.9946||90.0|156.0|326.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)|
1675746|NCT01306162|3082795|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|115.0|Standard Deviation|31.2||0.2207|2-Sided|90.0|95.0|138.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)|
1675747|NCT01306162|3082795|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|187.0|Standard Deviation|24.3||0.9999|2-Sided|90.0|162.0|215.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR (TrtB) vs 150mg DE (TrtA)|
1675748|NCT01306162|3082796|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtE: TrtA (%)|162.0|Standard Deviation|20.1||0.9171|2-Sided|90.0|119.0|221.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid 2h later (TrtE) vs 150mg DE (TrtA)|
1675749|NCT01306162|3082796|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtD: TrtA (%)|236.0|Standard Deviation|21.8||0.9992||90.0|173.0|321.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR bid same time (TrtD) vs 150mg DE (TrtA)|
1675750|NCT01306162|3082796|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtC: TrtA (%)|130.0|Standard Deviation|25.0||0.6697|2-Sided|90.0|112.0|151.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation|150mg DE + 400mg DR 2h later (TrtC) vs 150mg DE (TrtA)|
1675751|NCT01306162|3082796|Non-Inferiority or Equivalence|Bioavailability|Geometric mean ratio TrtB: TrtA (%)|214.0|Standard Deviation|19.9||1|2-Sided|90.0|191.0|240.0||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|ANOVA with sequence, period and treatment as fixed effects and subject within sequence as random effect.|The standard deviation is actually the Geometric coefficient of variation.|150mg DE + 400mg DR same time (TrtB) vs 150mg DE (TrtA)|
1675752|NCT01306058|3082798|Non-Inferiority|eos (end of study) vs. cycle 1 day 1. Paired T-test. Two tailed.||||||0.0009|||||||Wilcoxon signed rank test||||
1675753|NCT01306058|3082798|Non-Inferiority|Cycle 2 day 1 vs. cycle 1 day 1. Paired T-test. Two tailed.|||||<|0.0001|||||||Wilcoxon signed rank test||||
1675754|NCT01306058|3082798|Non-Inferiority|Paired T-test. Two tailed.|||||<|0.0001||||||Cycle 1 day 15 vs. cycle 1 day 1|Wilcoxon signed rank test||||
1675755|NCT01306058|3082799|Non-Inferiority|Paired T-test. Two tailed.|||||<|0.05|||||||Wilcoxon signed rank test||||
1675756|NCT01306032|3082819|Superiority or Other|||||||0.68|||||||Log Rank||||
1675757|NCT01306032|3082819|Superiority or Other|||||||0.034|||||||Log Rank||||
1675758|NCT01305811|3082830|Superiority or Other||||||=|0|||||||t-test, 2 sided|||In our original proposal to the funder, to protect our main outcome from possibly large attrition, we proposed to initially test mean differences between groups following 2 months of treatment or wait list using Student’s t-tests at an alpha=0.05.|
1675759|NCT01305811|3082831|Superiority or Other|||||||0.03|||||||general estimating equations||||
1675760|NCT01305577|3082840|Superiority or Other||||||<|0.001|||||||Pearson's chi-square test||||
1675761|NCT01305577|3082840|Superiority or Other||||||<|0.001|||||||Pearson's chi-square test||||
1675762|NCT01305577|3082841|Superiority or Other||LS Mean Difference|-1.97|||<|0.001|2-Sided|95.0|-2.79|-1.15|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit*treatment interaction, and the baseline values as covariate.|||
1675763|NCT01305577|3082841|Superiority or Other||LS mean Difference|-1.68|||<|0.001|2-Sided|95.0|-2.5|-0.87|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit*treatment interaction, and the Baseline values as covariate.|||
1676034|NCT01301079|3083419|Superiority or Other|||||||0.113|||||||Mann-Whitney||||
1675765|NCT01305577|3082842|Superiority or Other||LS Mean Difference|1.04|||<|0.001|2-Sided|95.0|0.61|1.47|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.|||
1675766|NCT01305577|3082843|Superiority or Other||LS Mean Difference|-0.67|||<|0.001|2-Sided|95.0|-0.84|-0.5|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit*treatment interaction, and the baseline CR-SMFRS values as covariate.|||
1675767|NCT01305577|3082843|Superiority or Other||LS Mean Difference|-0.51|||<|0.001|2-Sided|95.0|-0.68|-0.35|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit*treatment interaction, and the baseline CR-SMFRS values as covariate.|||
1675768|NCT01305577|3082844|Superiority or Other||Odds Ratio (OR)|5.22|||<|0.001|2-Sided|95.0|2.99|9.11|||Regression, Logistic|Logistic regression analysis with treatment and baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios >1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."|
1675769|NCT01305577|3082844|Superiority or Other||Odds Ratio (OR)|2.99|||<|0.001|2-Sided|95.0|1.74|5.14|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios >1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."|
1675770|NCT01305577|3082845|Superiority or Other||Odds Ratio (OR)|12.05|||<|0.001|2-Sided|95.0|2.75|52.9|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios >1 indicate a positive treatment effect.||
1675771|NCT01305577|3082845|Superiority or Other||Odds Ratio (OR)|5.58|||<|0.028|2-Sided|95.0|1.2|25.87|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios >1 indicate a positive treatment effect.||
1675772|NCT01305577|3082846|Superiority or Other||Odds Ratio (OR)|6.21|||<|0.001|2-Sided|95.0|3.52|10.94|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios >1 indicate a positive treatment effect.|The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo. An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme.|
1675773|NCT01305577|3082846|Superiority or Other||Odds Ratio (OR)|4.73|||<|0.001|2-Sided|95.0|2.7|8.28|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios >1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."|
1675774|NCT01305408|3082888|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.2717|2-Sided|95.0|-3.76|1.06||Statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.|||
1675775|NCT01305252|3082896|Superiority or Other|||||||0.33|||||||t-test, 2 sided||||
1675776|NCT01305252|3082896|Superiority or Other|||||||0.03|||||||t-test, 2 sided||||
1675777|NCT01305252|3082899|Superiority or Other|||||||0.17|||||||t-test, 2 sided||||
1675778|NCT01305252|3082899|Superiority or Other|||||||0.03|||||||t-test, 2 sided||||
1675779|NCT01304966|3082933|Superiority or Other|||||||0.013|||||||t-test, 1 sided||||
1675780|NCT01304641|3082939|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1675781|NCT01304641|3082940|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1675782|NCT01304641|3082941|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1675783|NCT01304641|3082942|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1675784|NCT01304641|3082943|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1675785|NCT01304641|3082944|Superiority or Other||Hazard Ratio (HR)|1.078||||0.14|2-Sided|95.0|0.976|1.192|||Regression, Cox||||
1675786|NCT01304641|3082945|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1675787|NCT01304589|3082946|Superiority or Other||||||<|0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided||||
1675788|NCT01304589|3082947|Superiority or Other|||||||0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided||||
1675789|NCT01304589|3082948|Superiority or Other|||||||0.003||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|paired T-test|"Subjects completed a tampon insertion pain test once a week. The values were averaged and compared pre-treatment versus post-treatment."|||
1675790|NCT01304589|3082949|Superiority or Other|||||||0.001||||||A paired T-Test was calculated assuming a standard difference (d) between the 4 paired outcomes for pain of 0.60 (moderate effect size), a SD of 1 for each outcome variable and a correlation of 0.50 between each paired variable.|t-test, 2 sided||||
1675791|NCT01304498|3082957|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was >0.67|GMT Ratio|1.08|||<|0.001|2-Sided|95.0|0.91|1.29|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 18|
1675792|NCT01304498|3082957|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was >0.67|GMT Ratio|0.97|||<|0.001|2-Sided|95.0|0.85|1.11|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|HPV Type 16|
1675793|NCT01304329|3082958|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|111.25|Standard Deviation|24.8|||2-Sided|90.0|95.93|129.02|||||Standard deviation is actually the gCV|"AUC of simvastatin acid.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."|
1675794|NCT01304329|3082958|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.34|Standard Deviation|41.7|||2-Sided|90.0|80.39|130.29|||||Standard deviation is actually the gCV|"AUC of simvastatin.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."|
1675795|NCT01304329|3082959|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.52|Standard Deviation|5.8|||2-Sided|90.0|99.1|106.06|||||Standard deviation is actually the gCV|Considered characteristic is empa plus simvastatin divided by empa alone.|
1675796|NCT01304329|3082960|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|97.27|Standard Deviation|22.7|||2-Sided|90.0|84.9|111.44|||||Standard deviation is actually the gCV|"Cmax of simvastatin acid.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."|
1675797|NCT01304329|3082960|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|97.18|Standard Deviation|41.7|||2-Sided|90.0|76.3|123.77|||||Standard deviation is actually the gCV|"Cmax of simvastatin.~Considered characteristic is empa plus simvastatin divided by simvastatin alone."|
1675798|NCT01304329|3082961|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|109.49|Standard Deviation|21.1|||2-Sided|90.0|96.91|123.69|||||Standard deviation is actually the gCV|Considered characteristic is empa plus simvastatin divided by empa alone|
1675799|NCT01304329|3082962|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|104.87|Standard Deviation|25.5|||2-Sided|90.0|90.09|122.07|||||Standard deviation is actually the gCV|"AUC of simvastatin acid~Considered characteristic is empa plus simvastatin divided by simvastatin alone."|
1675800|NCT01304329|3082962|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.26|Standard Deviation|40.4|||2-Sided|90.0|80.06|128.07|||||Standard deviation is actually the gCV|"AUC of simvastatin~Considered characteristic is empa plus simvastatin divided by simvastatin alone"|
1675801|NCT01304329|3082963|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.05|Standard Deviation|5.4|||2-Sided|90.0|98.9|105.29|||||Standard deviation is actually the geometric coefficient of variation (gCV)|Considered characteristic is empa plus simvastatin divided by empa alone|
1675802|NCT01304147|3082988|Superiority or Other||Mean Difference (Final Values)|7.6|||<|0.001|2-Sided|95.0|3.9|11.3|||Paired t-test, 2 sided|||within-subject crossover design|
1675803|NCT01304082|3082989|Superiority or Other||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"|
1675804|NCT01304082|3082990|Superiority or Other||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"|
1675805|NCT01304082|3082991|Superiority or Other||||||<|0.0001||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"|
1675806|NCT01304082|3082992|Superiority or Other|||||||0.7535||||||Bonferroni correction for pairwise comparisons|non-parametric Friedman ANOVA test|||"Analysis: Non-parametric Friedman ANOVA test on rank-transformed outcome with Bonferroni correction for pairwise comparisons.~Null hypothesis: No difference between the groups"|
1675807|NCT01303627|3083012|Superiority or Other||||||<|0.05||||||Statistical analyses were performed x2 test or Mann Whitney U test as approriate. A p value of <0.05 was considered statistically significant.|Chi-squared|||The incidence of complications on removal of the cLMA has been reported 54 % in awake patients group A power analysis indicated that a minimum 16 patients in each group were required to demonstrate a difference that 50% reduction the complications (a power of 80% and α error 0.05).|
1675808|NCT01303445|3083019|Non-Inferiority or Equivalence|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.02||||||90.0|98.46|99.59||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone|
1675809|NCT01303445|3083019|Non-Inferiority or Equivalence|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.38||||||90.0|98.8|99.95||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone|
1675810|NCT01303445|3083020|Non-Inferiority or Equivalence|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|106.09||||||90.0|98.64|114.09||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone|
1675811|NCT01303445|3083020|Non-Inferiority or Equivalence|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|105.55||||||90.0|97.09|114.74||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone|
1675812|NCT01303445|3083021|Non-Inferiority or Equivalence|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|98.42||||||90.0|97.66|99.18||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone|
1675813|NCT01303445|3083021|Non-Inferiority or Equivalence|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|99.02||||||90.0|98.32|99.72||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone|
1675842|NCT01302834|3083132|Superiority||Hazard Ratio (HR)|2.05||||0.0005|2-Sided|95.0|1.35|3.1|||Log Rank|Two-sided significance level = 0.05|Reference level = IMRT + Cisplatin||
1675814|NCT01303445|3083022|Non-Inferiority or Equivalence|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|97.03||||||95.0|93.26|100.95||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone|
1675815|NCT01303445|3083022|Non-Inferiority or Equivalence|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|96.38||||||90.0|90.96|102.13||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone|
1675816|NCT01303445|3083023|Non-Inferiority or Equivalence|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|92.3||||||90.0|87.76|97.08||||||Comparison of Aggrenox + Omeprazole following Aggrenox versus Aggrenox alone|
1675817|NCT01303445|3083023|Non-Inferiority or Equivalence|Bioequivalence was established if the 90% confidence interval of the mean ratio fell within the 80 to 125% target range.|Percent Mean Ratio|92.03||||||90.0|86.95|97.4||||||Comparison of Aggrenox + Omeprazole following Omeprazole versus Aggrenox alone|
1675818|NCT01303224|3083057|Superiority or Other||||||<|0.05||||||Multiplicity was adjusted using the Hochberg procedure.|Mantel Haenszel||||
1675819|NCT01303224|3083058|Superiority or Other||||||<|0.05||||||Multiplicity was adjusted by using the Hochberg Procedure.|Mantel Haenszel|||Mantel-Haenszel-Test was used to compare separately each of the 3 active treatment groups with placebo using a two-sided overall significance level of 5%. The proportion of responders was tested with the following hypotheses: H0 (placebo) vs H1(Ibodutant:1mg/3mg/10mg). Approximately 80% power based on the assumptions: rate placebo 40%, expected mean therapeutic gain over placebo 15% for at least one dose of Ibodutant.|
1675820|NCT01302938|3083075|Superiority or Other||Median Difference (Final Values)|4.0|||||2-Sided|95.0|-20.0|20.0||||||Change at Week 12; Social Subscale: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.|
1675821|NCT01302938|3083076|Superiority or Other||LS mean difference|9.0|Standard Error of the Mean|9.3|||2-Sided|95.0|-11.0|29.0||||||Change at Week 12; Total HRQL Score: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.|
1675822|NCT01302938|3083076|Superiority or Other||LS mean difference|10.3|Standard Error of the Mean|10.9|||2-Sided|95.0|-13.3|33.8||||||Change at Week 12; Sleep Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.|
1675823|NCT01302938|3083076|Superiority or Other||LS mean difference|8.0|Standard Error of the Mean|11.4|||2-Sided|95.0|-16.7|32.7||||||Change at Week 12; Concern Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.|
1675824|NCT01302938|3083076|Superiority or Other||LS mean difference|11.7|Standard Error of the Mean|8.6|||2-Sided|95.0|-6.9|30.3||||||Change at Week 12; Coping Subscale: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.|
1675825|NCT01302938|3083077|Superiority or Other||LS mean difference|-10.0|Standard Error of the Mean|10.8|||2-Sided|95.0|-33.2|13.2||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.|
1675826|NCT01302938|3083080|Superiority or Other||LS mean difference|-2.9|Standard Error of the Mean|1.5|||2-Sided|95.0|-6.3|0.4||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.|
1675827|NCT01302938|3083080|Superiority or Other||LS mean difference|-1.4|Standard Error of the Mean|1.1|||2-Sided|95.0|-3.7|0.8||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.|
1675828|NCT01302938|3083080|Superiority or Other||LS mean difference|0.6|Standard Error of the Mean|0.6|||2-Sided|95.0|-0.8|1.9||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.|
1675829|NCT01302938|3083083|Superiority or Other||LS mean difference|-0.6|Standard Error of the Mean|0.7|||2-Sided|95.0|-2.2|0.9||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.|
1675830|NCT01302938|3083083|Superiority or Other||LS mean difference|0.3|Standard Error of the Mean|0.7|||2-Sided|95.0|-1.3|1.8||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.|
1675831|NCT01302938|3083084|Superiority or Other||Median Difference (Final Values)|-0.5|||||2-Sided|95.0|-3.0|1.0||||||Change at Week 12: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.|
1675832|NCT01302938|3083084|Superiority or Other||Median Difference (Final Values)|0.58|||||2-Sided|95.0|-1.0|1.83||||||Change at Week 4: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95% CI.|
1675833|NCT01302938|3083084|Superiority or Other||Median Difference (Final Values)|0.17|||||2-Sided|95.0|-0.67|1.67||||||Change at Week 1: Non-parametric Hodges-Lehmann's method was used to obtain median difference and 95 percent (%) confidence intervals (CI).|
1675834|NCT01302938|3083085|Superiority or Other||LS mean difference|43.0|Standard Error of the Mean|31.4|||2-Sided|95.0|-24.2|110.3||||||Change at Week 12: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.|
1675835|NCT01302938|3083085|Superiority or Other||LS mean difference|28.0|Standard Error of the Mean|38.9|||2-Sided|95.0|-55.4|111.4||||||Change at Week 4: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.|
1675836|NCT01302938|3083085|Superiority or Other||LS mean difference|29.4|Standard Error of the Mean|35.4|||2-Sided|95.0|-47.8|106.6||||||Change at Week 1: Analysis was performed using an ANCOVA with term for treatment with baseline value as a covariate.|
1675837|NCT01302938|3083086|Superiority or Other||Least squares (LS) mean difference|-1.6|Standard Error of the Mean|1.0|||2-Sided|95.0|-3.9|0.6||||||Change at Week 12: Analysis was performed using an analysis of covariance (ANCOVA) with term for treatment with baseline value as a covariate.|
1675838|NCT01302834|3083120|Superiority|||||||0.79||||||Two-sided significance level = 0.05|Fisher Exact||||
1675839|NCT01302834|3083128|Superiority|||||||1||||||Two-sided significance level = 0.05|Fisher Exact||||
1675840|NCT01302834|3083130|Superiority||Hazard Ratio (HR)|0.99||||0.95|2-Sided|95.0|0.61|1.58||Two-sided significance level = 0.05|Log Rank||Reference level = IMRT + Cisplatin||
1675841|NCT01302834|3083131|Superiority||Hazard Ratio (HR)|1.49||||0.09|2-Sided|95.0|0.94|2.36||Two-sided significance level = 0.05|Log Rank||Reference level = IMRT + Cisplatin||
1675844|NCT01302834|3083134|Non-Inferiority|The non-inferiority margin was set at 1.45 (hazard ratio scale; IMRT + Cetuximab / IMRT + Cisplatin). If the upper limit of the 95% confidence interval was <1.45, non-inferiority would be concluded. Design was based on a group sequential design with 3 interim analyses, one-sided 0.05, and 80% power.|Hazard Ratio (HR)|1.45|||||1-Sided|95.0||1.94|||||Reference level = IMRT + Cisplatin||
1675845|NCT01302691|3083137|Superiority or Other||Difference in Least Squares Means|-3.2||||0.011|2-Sided|95.0|-5.7|-0.8|||Constrained Longitudinal Data Analysis|Model includes treatment group, time point, and the interaction of time by treatment with restriction of same baseline mean across treatment groups|||
1675846|NCT01302691|3083143|Superiority or Other||Difference in Least Squares Means|-1.1||||0.205|2-Sided|95.0|-2.7|0.6|||Constrained Longitudinal Data Analysis|Model includes treatment group, time point, and the interaction of time by treatment with restriction of same baseline mean across treatment groups|||
1675847|NCT01302548|3083144|Superiority or Other||Mean Difference (Net)|-0.4|Standard Deviation|0.5477||0.5415|2-Sided|95.0|-2.0659|1.2659||This is unadjusted.|t-test, 2 sided|Degrees of freedom = 4||"Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing in patients that are MRSA positive.~This study did not enroll an adequate number of patients to meet sufficient power."|
1675848|NCT01302548|3083145|Superiority or Other||Odds Ratio (OR)|0.2364||||0.3575|2-Sided|95.0|0.0239|2.3394||This is unadjusted.|Fisher Exact|Cell (1,1) Frequency (F) = 13||"Ho: There is not a significant difference between the proportion of patients requiring antibiotics after the use of IRRISEPT solution vs. the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power."|
1675849|NCT01302548|3083146|Superiority or Other||Mean Difference (Net)|0.0833|Standard Deviation|0.8609||0.797|2-Sided|95.0|-0.5738|0.7405||This is unadjusted.|t-test, 2 sided|Degrees of freedom = 28||"Ho: There is not a significant difference between the use of IRRISEPT solution and the usual care methods on abscess healing.~This study did not enroll an adequate number of patients to meet sufficient power."|
1675850|NCT01302392|3083168|Superiority or Other||Hazard Ratio (HR)|0.975||||0.4172|2-Sided|95.0|0.76|1.249||Based on 1-sided test.|Log Rank|Analysis was stratified by the number of previous therapies (3 vs 4 vs ≥ 5) and geographical region (Europe vs. non-Europe)|||
1675851|NCT01302119|3083172|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1675852|NCT01302119|3083173|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1675853|NCT01302119|3083174|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1675854|NCT01302119|3083175|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1675855|NCT01302067|3083176|Superiority or Other|||||||0.0027||||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.|
1675856|NCT01302067|3083176|Superiority or Other|||||||0.0006||||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.|
1675857|NCT01302067|3083176|Superiority or Other||||||<|0.0001||||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.|
1675858|NCT01302067|3083177|Superiority or Other|||||||0.0015||||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.|
1675859|NCT01302067|3083177|Superiority or Other|||||||0.8121||||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.|
1675860|NCT01302067|3083177|Superiority or Other|||||||0.0016||||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.|
1675861|NCT01302067|3083178|Superiority or Other||Least squares mean difference|5.14|Standard Error of the Mean|1.43||0.0003|2-Sided|95.0|2.34|7.94||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675862|NCT01302067|3083178|Superiority or Other||Least squares mean difference|4.23|Standard Error of the Mean|1.17||0.0003|2-Sided|95.0|1.93|6.53||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675863|NCT01302067|3083178|Superiority or Other||Least squares mean difference|9.37|Standard Error of the Mean|1.43|<|0.0001|2-Sided|95.0|6.56|12.18||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675864|NCT01302067|3083179|Superiority or Other||Least squares mean difference|3.82|Standard Error of the Mean|1.25||0.0023|2-Sided|95.0|1.36|6.28||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675865|NCT01302067|3083179|Superiority or Other||Least squares mean difference|3.68|Standard Error of the Mean|1.03||0.0004|2-Sided|95.0|1.65|5.7||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1676035|NCT01301027|3083421|Superiority or Other|||||||0.984|||||||t-test, 2 sided||||
1676036|NCT01301027|3083422|Superiority or Other|||||||0.508|||||||t-test, 2 sided||||
1676037|NCT01301027|3083423|Superiority or Other|||||||0.059|||||||t-test, 2 sided||||
1675866|NCT01302067|3083179|Superiority or Other||Least squares mean difference|7.5|Standard Error of the Mean|1.26|<|0.0001|2-Sided|95.0|5.03|9.97||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675867|NCT01302067|3083180|Superiority or Other||Least squares mean difference|3.72|Standard Error of the Mean|1.55||0.0164|2-Sided|95.0|0.68|6.76||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675868|NCT01302067|3083180|Superiority or Other||Least squares mean difference|3.74|Standard Error of the Mean|1.27||0.0034|2-Sided|95.0|1.24|6.23||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675869|NCT01302067|3083180|Superiority or Other||Least squares mean difference|7.46|Standard Error of the Mean|1.56|<|0.0001|2-Sided|95.0|4.4|10.51||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675870|NCT01302067|3083181|Superiority or Other||Least squares mean difference|6.55|Standard Error of the Mean|1.61|<|0.0001|2-Sided|95.0|3.39|9.72||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675871|NCT01302067|3083181|Superiority or Other||Least squares mean difference|4.36|Standard Error of the Mean|1.33|<|0.001|2-Sided|95.0|1.76|6.96||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675872|NCT01302067|3083181|Superiority or Other||Least squares mean difference|10.91|Standard Error of the Mean|1.62|<|0.0001|2-Sided|95.0|7.73|14.09||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675873|NCT01302067|3083182|Superiority or Other||Least squares mean difference|5.78|Standard Error of the Mean|1.66||0.0005|2-Sided|95.0|2.53|9.03||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675874|NCT01302067|3083182|Superiority or Other||Least squares mean difference|4.68|Standard Error of the Mean|1.36||0.0006|2-Sided|95.0|2.01|7.36||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675875|NCT01302067|3083182|Superiority or Other||Least squares mean difference|10.46|Standard Error of the Mean|1.67|<|0.0001|2-Sided|95.0|7.2|13.73||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675876|NCT01302067|3083183|Superiority or Other||Least squares mean difference|-7.78|Standard Error of the Mean|1.53|<|0.0001|2-Sided|95.0|-10.78|-4.78||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.|
1675877|NCT01302067|3083183|Superiority or Other||Least squares mean difference|-4.69|Standard Error of the Mean|1.26|<|0.0002|2-Sided|95.0|-7.15|-2.22||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.|
1675878|NCT01302067|3083183|Superiority or Other||Least squares mean difference|-12.47|Standard Error of the Mean|1.54|<|0.0001|2-Sided|95.0|-15.49|-9.45||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.|
1675879|NCT01302067|3083184|Superiority or Other|||||||0.3901||||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.|
1675880|NCT01302067|3083184|Superiority or Other|||||||0.0091||||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.|
1675881|NCT01302067|3083184|Superiority or Other|||||||0.0007||||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.|
1676038|NCT01301027|3083424|Superiority or Other|||||||0.047|||||||t-test, 2 sided||||
1675882|NCT01302067|3083185|Superiority or Other|||||||0.0008||||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.|
1675883|NCT01302067|3083185|Superiority or Other|||||||0.0057||||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.|
1675884|NCT01302067|3083185|Superiority or Other||||||<|0.0001||||||A closed-testing procedure was used for the treatment comparison.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.|
1675885|NCT01302067|3083186|Superiority or Other||||||<|0.0001||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675886|NCT01302067|3083186|Superiority or Other||||||<|0.0002||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675887|NCT01302067|3083186|Superiority or Other||||||<|0.0001||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675888|NCT01302067|3083187|Superiority or Other|||||||0.0003||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675889|NCT01302067|3083187|Superiority or Other|||||||0.0348||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675890|NCT01302067|3083187|Superiority or Other||||||<|0.0001||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675891|NCT01302067|3083188|Superiority or Other||Least squares mean difference|-1.24|Standard Error of the Mean|0.27|<|0.0001|2-Sided|95.0|-1.77|-0.71||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.|
1675892|NCT01302067|3083188|Superiority or Other||Least squares mean difference|-0.78|Standard Error of the Mean|0.22|<|0.0005|2-Sided|95.0|-1.22|-0.34||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.|
1675893|NCT01302067|3083188|Superiority or Other||Least squares mean difference|-2.02|Standard Error of the Mean|0.27|<|0.0001|2-Sided|95.0|-2.55|-1.49||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.|
1675894|NCT01302067|3083189|Superiority or Other||Least squares mean difference|-1.04|Standard Error of the Mean|0.25|<|0.0001|2-Sided|95.0|-1.52|-0.55||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.|
1675895|NCT01302067|3083189|Superiority or Other||Least squares mean difference|-0.52|Standard Error of the Mean|0.21|<|0.0121|2-Sided|95.0|-0.92|-0.11||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.|
1675896|NCT01302067|3083189|Superiority or Other||Least squares mean difference|-1.55|Standard Error of the Mean|0.25|<|0.0001|2-Sided|95.0|-2.04|-1.06||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.|
1675897|NCT01302067|3083190|Superiority or Other|||||||0.0001||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675898|NCT01302067|3083190|Superiority or Other|||||||0.0006||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675899|NCT01302067|3083190|Superiority or Other||||||<|0.0001||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675900|NCT01302067|3083191|Superiority or Other||||||<|0.0001||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675901|NCT01302067|3083191|Superiority or Other||||||<|0.0001||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675902|NCT01302067|3083192|Superiority or Other||Least squares mean difference|-0.56|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-0.82|-0.3||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675903|NCT01302067|3083192|Superiority or Other||Least squares mean difference|-0.2|Standard Error of the Mean|0.11|<|0.0662|2-Sided|95.0|-0.41|0.01||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675904|NCT01302067|3083192|Superiority or Other||Least squares mean difference|-0.76|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-1.02|-0.5||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.|
1675905|NCT01302067|3083193|Superiority or Other||||||<|0.0001||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675906|NCT01302067|3083193|Superiority or Other||||||<|0.0001||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675907|NCT01302067|3083193|Superiority or Other||||||<|0.0001||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675908|NCT01302067|3083194|Superiority or Other||||||<|0.0001||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675909|NCT01302067|3083194|Superiority or Other||||||<|0.004||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675910|NCT01302067|3083194|Superiority or Other||||||<|0.0001||||||A closed-testing procedure was used for the treatment comparison.|ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.|
1675911|NCT01302067|3083195|Superiority or Other||Least squares mean difference|-0.87|Standard Error of the Mean|0.19|<|0.0001|2-Sided|95.0|-1.23|-0.51||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.|
1675912|NCT01302067|3083195|Superiority or Other||Least squares mean difference|-0.53|Standard Error of the Mean|0.15|<|0.0006|2-Sided|95.0|-0.83|-0.23||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.|
1675913|NCT01302067|3083195|Superiority or Other||Least squares mean difference|-1.4|Standard Error of the Mean|0.19|<|0.0001|2-Sided|95.0|-1.76|-1.03||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.|
1675914|NCT01302067|3083196|Superiority or Other||Least squares mean difference|-0.75|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.1|-0.41||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.|
1675915|NCT01302067|3083196|Superiority or Other||Least squares mean difference|-0.38|Standard Error of the Mean|0.14|<|0.0082|2-Sided|95.0|-0.67|-0.1||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.|
1675916|NCT01302067|3083196|Superiority or Other||Least squares mean difference|-1.13|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.48|-0.79||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.|
1676039|NCT01301001|3083425|Superiority||Mean Difference (Final Values)|-0.2||||0.36|2-Sided|95.0|-0.5|0.2|||Mixed Models Analysis||||
1675917|NCT01302067|3083197|Superiority or Other||Least squares mean difference|-0.64|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-0.89|-0.39||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Treatment comparisons were performed with a two-sided test at the 5% significance level.|
1675918|NCT01302067|3083197|Superiority or Other||Least squares mean difference|-0.27|Standard Error of the Mean|0.11|<|0.0109|2-Sided|95.0|-0.48|-0.06||A closed-testing procedure was used for the treatment comparison.|ANCOVA||Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Treatment comparisons were performed with a two-sided test at the 5% significance level.|
1675919|NCT01302067|3083197|Superiority or Other||Least squares mean difference|-0.91|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-1.16|-0.66||Primary comparison was 8 mg VS. 4 mg (closed-testing method). Treatment effect of 8 mg VS. placebo was tested 1st. Treatment difference of 8 mg VS. 4 mg was tested if a statistically significant difference between 8 mg and placebo was shown.|ANCOVA|Using a closed testing procedure, no adjustments of α-level was needed at each stage of testing. Each was done at the 0.05 significance level.|Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.|Comparisons were done with 2-sided test at 5% significance level. Null hypothesis: mean change from BL in the number of UUI episodes per 24 hours in the 8mg group was same as 4mg group at Week 12. ANCOVA was used to compare 8mg and 4mg arms for numeric change from BL - Week 12. This included terms for treatment, country, centered BL value and centered BL by treatment interaction, in which centered BL (BL – mean BL) was used to ensure that treatment effect was estimated at mean covariate value.|
1675920|NCT01302054|3083198|Superiority or Other|||||||0.1461||||||Treatment difference at Week 12: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel||||
1675921|NCT01302054|3083198|Superiority or Other|||||||0.0427||||||Treatment difference at Week 4: p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel||||
1675922|NCT01302054|3083199|Superiority or Other|||||||0.0027||||||The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel||||
1675923|NCT01302054|3083200|Superiority or Other|||||||0.0023||||||The p-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test and stratified by country.|Cochran-Mantel-Haenszel||||
1675924|NCT01302054|3083201|Superiority or Other||LS Mean Difference|7.1|Standard Error of the Mean|1.77|<|0.0001|2-Sided|95.0|3.63|10.57||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Total HRQL - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.|
1675925|NCT01302054|3083201|Superiority or Other||LS Mean Difference|4.13|Standard Error of the Mean|1.64|<|0.0123|2-Sided|95.0|0.9|7.36||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Social Interaction Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.|
1675926|NCT01302054|3083201|Superiority or Other||LS Mean Difference|6.52|Standard Error of the Mean|2.0|<|0.0012|2-Sided|95.0|2.6|10.45||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Sleep Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.|
1675927|NCT01302054|3083201|Superiority or Other||LS Mean Difference|7.75|Standard Error of the Mean|1.97|<|0.0001|2-Sided|95.0|3.87|11.62||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Coping Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.|
1675928|NCT01302054|3083201|Superiority or Other||Least Squares (LS) Mean Difference|9.01|Standard Error of the Mean|1.98|<|0.0001|2-Sided|95.0|5.12|12.91||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Concern Subscale - Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.|
1675929|NCT01302054|3083202|Superiority or Other||Least Squares Mean Difference|-7.34|Standard Error of the Mean|1.91||0.0001|2-Sided|95.0|-11.1|-3.58||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.|
1675930|NCT01302054|3083203|Superiority or Other|||||||0.0095||||||Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.|Cochran-Mantel-Haenszel||||
1675931|NCT01302054|3083204|Superiority or Other||||||<|0.0001||||||Change at Week 12: the p-value was obtained from a Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country.|Cochran-Mantel-Haenszel||||
1675932|NCT01302054|3083205|Superiority or Other||Least Squares Mean Difference|-0.7|Standard Error of the Mean|0.34||0.0438|2-Sided|95.0|-1.37|-0.02||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.|
1675933|NCT01302054|3083206|Superiority or Other||Least Squares Mean Difference|-0.4|Standard Error of the Mean|0.24||0.0931|2-Sided|95.0|-0.86|0.07||Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used.|
1675934|NCT01302054|3083207|Superiority or Other||Least Squares Mean Difference|-0.5|Standard Error of the Mean|0.19||0.0079|2-Sided|95.0|-0.87|-0.13||Change at Week 12: ANCOVA model with terms for treatment and country with centered baseline value as a covariate was used. Statistical testing: one-sided, at alpha = 0.025.|ANCOVA|||Multiple hypothesis testing was carried out in a hierarchical sequentially rejective manner. Statistical testing between fesoterodine and placebo (Analysis of covariance [ANCOVA]) was carried out only if the change from baseline at Week 12 in UUI episodes for fesoterodine group was found statistically significant (paired t-test).|
1675935|NCT01302054|3083208|Superiority or Other||Least Squares Mean Difference|-2.37|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-2.63|-2.02||Statistical testing: one-sided, at alpha = 0.025.|t-test, 1 sided||||
1675958|NCT01301456|3083338|Superiority or Other||LS Mean Difference|0.96|Standard Error of the Mean|0.542||0.089|2-Sided|80.0|0.24|1.67|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1676089|NCT01299909|3083576|Superiority||Mean Difference (Final Values)|4.96||||0.03|2-Sided||||||ANOVA|df=(1,57)|||
1675936|NCT01301950|3083245|Superiority or Other|||||||0.54|||||||ANOVA|||The null hypothesis was no difference in skin-to-skin time. The alternative hypothesis was that the TruMatch group time was less than the conventional group. Statistical power was anticipated to be 86% with 40 enrolled subjects based upon a Cohen's D effect size of 1. The Sponsor had difficulty identifying and recruiting sites suitable for participation. The statistically required sample size (N=40) was therefore not obtained, causing the group comparison to be statistically underpowered.|
1675937|NCT01301742|3083251|Non-Inferiority or Equivalence|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|158.29|Standard Deviation|7.7|||2-Sided|90.0|151.41|165.49|||||Standard deviation is actually the intra-individual gCV||
1675938|NCT01301742|3083252|Non-Inferiority or Equivalence|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|115.0|Standard Deviation|13.8|||2-Sided|90.0|106.15|124.59|||||Standard deviation is actually the intra-individual gCV||
1675939|NCT01301742|3083253|Non-Inferiority or Equivalence|Ratio calculated as empa and gemfibrozil divided by empa alone|Geometric Mean Ratio|158.5|Standard Deviation|7.5|||2-Sided|90.0|151.77|165.53|||||Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)||
1675940|NCT01301508|3083331|Superiority or Other|||||||0.017||||||p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2728 Topical Ointment, 2% + Ointment Vehicle group.|Two-sided sign test||||
1675941|NCT01301508|3083331|Superiority or Other|||||||0.008||||||p-value was calculated for the statistical significant difference between greater decrease in vehicle lesion and greater decrease in active lesion for the AN2898 Topical Ointment, 1% + Ointment Vehicle group.|Two-sided sign test||||
1675942|NCT01301456|3083338|Superiority or Other||LS Mean Difference|0.47|Standard Error of the Mean|1.26||0.71|2-Sided|80.0|-1.18|2.13|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675943|NCT01301456|3083338|Superiority or Other||LS Mean Difference|1.24|Standard Error of the Mean|1.201||0.311|2-Sided|80.0|-0.34|2.82|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675944|NCT01301456|3083338|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|1.201||0.568|2-Sided|80.0|-2.27|0.88|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675945|NCT01301456|3083338|Superiority or Other||LS Mean Difference|-0.04|Standard Error of the Mean|1.317||0.979|2-Sided|80.0|-1.77|1.7|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675946|NCT01301456|3083338|Superiority or Other||LS Mean Difference|1.27|Standard Error of the Mean|1.129||0.272|2-Sided|80.0|-0.22|2.75|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675947|NCT01301456|3083338|Superiority or Other||LS Mean Difference|1.06|Standard Error of the Mean|1.092||0.342|2-Sided|80.0|-0.38|2.49|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675948|NCT01301456|3083338|Superiority or Other||LS Mean Difference|1.48|Standard Error of the Mean|1.069||0.179|2-Sided|80.0|0.07|2.88|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675949|NCT01301456|3083338|Superiority or Other||LS Mean Difference|1.09|Standard Error of the Mean|1.172||0.362|2-Sided|80.0|-0.45|2.63|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675950|NCT01301456|3083338|Superiority or Other||LS mean Difference|1.11|Standard Error of the Mean|1.021||0.286|2-Sided|80.0|-0.23|2.45|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675951|NCT01301456|3083338|Superiority or Other||LS mean Difference|0.74|Standard Error of the Mean|0.993||0.461|2-Sided|80.0|-0.56|2.05|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675952|NCT01301456|3083338|Superiority or Other||LS mean Difference|1.6|Standard Error of the Mean|0.97||0.11|2-Sided|80.0|0.33|2.88|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675953|NCT01301456|3083338|Superiority or Other||LS Mean Difference|1.0|Standard Error of the Mean|1.064||0.358|2-Sided|80.0|-0.4|2.4|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675954|NCT01301456|3083338|Superiority or Other||LS Mean Difference|0.62|Standard Error of the Mean|0.888||0.492|2-Sided|80.0|-0.55|1.79|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675955|NCT01301456|3083338|Superiority or Other||LS Mean Difference|0.27|Standard Error of the Mean|0.861||0.752|2-Sided|80.0|-0.86|1.41|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675956|NCT01301456|3083338|Superiority or Other||LS Mean Difference|1.25|Standard Error of the Mean|0.841||0.15|2-Sided|80.0|0.14|2.35|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675957|NCT01301456|3083338|Superiority or Other||LS Mean Difference|0.73|Standard Error of the Mean|0.923||0.434|2-Sided|80.0|-0.48|1.95|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1676029|NCT01301079|3083414|Superiority or Other|||||||0.221|||||||t-test, 2 sided||||
1675959|NCT01301456|3083338|Superiority or Other||LS Mean Difference|-0.03|Standard Error of the Mean|0.518||0.956|2-Sided|80.0|-0.71|0.65|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675960|NCT01301456|3083338|Superiority or Other||LS Mean Difference|0.52|Standard Error of the Mean|0.501||0.309|2-Sided|80.0|-0.14|1.18|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675961|NCT01301456|3083338|Superiority or Other||LS Mean Difference|0.48|Standard Error of the Mean|0.551||0.387|2-Sided|80.0|-0.24|1.21|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675962|NCT01301456|3083340|Superiority or Other||LS Mean Difference|6.79|Standard Error of the Mean|12.877||0.603|2-Sided|80.0|-10.15|23.72|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675963|NCT01301456|3083340|Superiority or Other||LS Mean Difference|-3.05|Standard Error of the Mean|12.333||0.807|2-Sided|80.0|-19.27|13.17|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675964|NCT01301456|3083340|Superiority or Other||LS Mean Difference|5.4|Standard Error of the Mean|12.365||0.666|2-Sided|80.0|-10.86|21.66|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675965|NCT01301456|3083340|Superiority or Other||LS Mean Difference|5.08|Standard Error of the Mean|13.576||0.711|2-Sided|80.0|-12.77|22.93|||Mixed meal tolerance test|||Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675966|NCT01301456|3083340|Superiority or Other||LS Mean Difference|-28.63|Standard Error of the Mean|11.837||0.023|2-Sided|80.0|-44.19|-13.06|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675967|NCT01301456|3083340|Superiority or Other||LS Mean Difference|-22.48|Standard Error of the Mean|10.773||0.047|2-Sided|80.0|-36.65|-8.32|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675968|NCT01301456|3083340|Superiority or Other||LS Mean Difference|-28.17|Standard Error of the Mean|10.393||0.012|2-Sided|80.0|-41.84|-14.51|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675969|NCT01301456|3083340|Superiority or Other||LS Mean Difference|-15.15|Standard Error of the Mean|11.421||0.196|2-Sided|80.0|-30.17|-0.13|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675970|NCT01301456|3083340|Superiority or Other||LS Mean Difference|-14.47|Standard Error of the Mean|9.198||0.128|2-Sided|80.0|-26.57|-2.38|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675971|NCT01301456|3083340|Superiority or Other||LS Mean Difference|-10.6|Standard Error of the Mean|9.061||0.253|2-Sided|80.0|-22.51|1.32|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675972|NCT01301456|3083340|Superiority or Other||LS Mean Difference|-25.46|Standard Error of the Mean|8.827||0.008|2-Sided|80.0|-37.07|-13.85|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675973|NCT01301456|3083340|Superiority or Other||LS Mean Difference|-3.75|Standard Error of the Mean|9.713||0.703|2-Sided|80.0|-16.52|9.02|||Mixed meal tolerance test|||Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675974|NCT01301456|3083340|Superiority or Other||LS Mean Difference|-7.21|Standard Error of the Mean|12.365||0.565|2-Sided|80.0|-23.47|9.05|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675975|NCT01301456|3083340|Superiority or Other||LS Mean Difference|-2.61|Standard Error of the Mean|12.212||0.833|2-Sided|80.0|-18.67|13.45|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675976|NCT01301456|3083340|Superiority or Other||LS Mean Difference|-32.46|Standard Error of the Mean|11.872||0.011|2-Sided|80.0|-48.07|-16.85|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675977|NCT01301456|3083340|Superiority or Other||LS Mean Difference|0.68|Standard Error of the Mean|13.037||0.959|2-Sided|80.0|-16.46|17.82|||Mixed meal tolerance test|||Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675978|NCT01301456|3083340|Superiority or Other||LS Mean Difference|0.72|Standard Error of the Mean|8.829||0.936|2-Sided|80.0|-10.89|12.33|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675979|NCT01301456|3083340|Superiority or Other||LS Mean Difference|1.36|Standard Error of the Mean|8.791||0.878|2-Sided|80.0|-10.2|12.92|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675980|NCT01301456|3083340|Superiority or Other||LS Mean Difference|-1.89|Standard Error of the Mean|8.472||0.825|2-Sided|80.0|-13.03|9.25|||mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675981|NCT01301456|3083340|Superiority or Other||LS Mean Difference|4.11|Standard Error of the Mean|9.326||0.663|2-Sided|80.0|-8.16|16.37|||Mixed meal tolerance test|||Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675982|NCT01301456|3083342|Superiority or Other||LS Mean Difference|-0.43|Standard Error of the Mean|0.244||0.086|2-Sided|80.0|-0.76|-0.11|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675983|NCT01301456|3083342|Superiority or Other||LS Mean Difference|-0.34|Standard Error of the Mean|0.23||0.147|2-Sided|80.0|-0.65|-0.04|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675984|NCT01301456|3083342|Superiority or Other||LS Mean Difference|-0.41|Standard Error of the Mean|0.224||0.077|2-Sided|80.0|-0.71|-0.12|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675985|NCT01301456|3083342|Superiority or Other||LS Mean Difference|-0.21|Standard Error of the Mean|0.251||0.419|2-Sided|80.0|-0.54|0.12|||Mixed meal tolerance test|||Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.|
1675986|NCT01301456|3083343|Superiority or Other||LS mean|-2.93|Standard Error of the Mean|16.111||0.857|2-Sided|80.0|-24.16|18.31|||Mixed meal tolerance test|||Day 30|
1675987|NCT01301456|3083343|Superiority or Other||LS mean|-33.67|Standard Error of the Mean|15.806||0.044|2-Sided|80.0|-54.5|-12.84|||Mixed meal tolerance test|||Day 30|
1675988|NCT01301456|3083343|Superiority or Other||LS mean|-34.18|Standard Error of the Mean|15.189||0.034|2-Sided|80.0|-54.2|-14.16|||Mixed meal tolerance test|||Day 30|
1675989|NCT01301456|3083343|Superiority or Other||Least square (LS) mean|-21.16|Standard Error of the Mean|16.766||0.219|2-Sided|80.0|-43.26|0.93|||Mixed meal tolerance test|||Day 30|
1675990|NCT01301391|3083375|Superiority||Single proportion|0.54|||<|0.001|2-Sided|95.0|0.33|0.74||A priori threshold for statistical significance = 0.05|Fisher Exact|||H0:p≤ 25% vs H1:p> 25% with an interesting PFS-3 rate of 50% (median PFS of 3 months), alpha=0.05 and beta=0.10, 30 evaluable patients are required for a single stage trial. If at the end of the trial 12 or more out of 30 evaluable patients are alive and progression-free at 3 months since the treatment start date, the null hypothesis are rejected. A Fleming multiple-testing procedure is applied. If >=4 successes out of the first 15 patients are observed, accrual will continue up to 30.|
1675991|NCT01301274|3083376|Superiority or Other|||||||0.129|||||||t-test, 2 sided||||
1675992|NCT01301274|3083377|Superiority or Other|||||||0.396|||||||t-test, 2 sided||||
1675993|NCT01301274|3083378|Superiority or Other|||||||0.081||||||without adjust|Chi-squared||||
1675994|NCT01301274|3083379|Non-Inferiority or Equivalence|beta error 20%, alfa error 5%, diminished 2 mEq/L between groups||||||0.04|||||||t-test, 2 sided||||
1675995|NCT01301092|3083380|Superiority or Other||Ratio of Geometric LS Means|1.05|||||2-Sided|90.0|0.924|1.19|||||||
1675996|NCT01301092|3083381|Superiority or Other||Ratio of Geometric LS Means|0.962|||||2-Sided|90.0|0.858|1.08|||||||
1675997|NCT01301092|3083382|Superiority or Other||Ratio of Geometric LS Mean|2.1|||||2-Sided|90.0|1.84|2.41|||||||
1675998|NCT01301092|3083383|Superiority or Other||Ratio of Geometric LS Mean|0.443|||||2-Sided|90.0|0.395|0.497|||||||
1675999|NCT01301079|3083384|Superiority or Other|||||||0.557|||||||t-test, 2 sided||||
1676000|NCT01301079|3083385|Superiority or Other|||||||0.745|||||||t-test, 2 sided||||
1676001|NCT01301079|3083386|Superiority or Other|||||||0.435|||||||t-test, 2 sided||||
1676002|NCT01301079|3083387|Superiority or Other|||||||0.5|||||||t-test, 2 sided||||
1676003|NCT01301079|3083388|Superiority or Other|||||||0.422|||||||t-test, 2 sided||||
1676004|NCT01301079|3083389|Superiority or Other|||||||0.385|||||||t-test, 2 sided||||
1676005|NCT01301079|3083390|Superiority or Other|||||||0.938|||||||t-test, 2 sided||||
1676006|NCT01301079|3083391|Superiority or Other|||||||0.676|||||||t-test, 2 sided||||
1676007|NCT01301079|3083392|Superiority or Other|||||||0.312|||||||t-test, 2 sided||||
1676008|NCT01301079|3083393|Superiority or Other|||||||0.611|||||||Chi-squared||||
1676009|NCT01301079|3083394|Superiority or Other|||||||0.313|||||||Chi-squared||||
1676010|NCT01301079|3083395|Superiority or Other|||||||0.313|||||||Chi-squared||||
1676011|NCT01301079|3083396|Superiority or Other|||||||0.313|||||||Chi-squared||||
1676012|NCT01301079|3083397|Superiority or Other|||||||0.593|||||||t-test, 2 sided||||
1676013|NCT01301079|3083398|Superiority or Other|||||||0.65|||||||t-test, 2 sided||||
1676014|NCT01301079|3083399|Superiority or Other|||||||0.545|||||||t-test, 2 sided||||
1676015|NCT01301079|3083400|Superiority or Other|||||||0.677|||||||t-test, 2 sided||||
1676016|NCT01301079|3083401|Superiority or Other|||||||0.077|||||||t-test, 2 sided||||
1676017|NCT01301079|3083402|Superiority or Other|||||||0.586|||||||t-test, 2 sided||||
1676018|NCT01301079|3083403|Superiority or Other|||||||0.673|||||||t-test, 2 sided||||
1676019|NCT01301079|3083404|Superiority or Other|||||||0.54|||||||t-test, 2 sided||||
1676020|NCT01301079|3083405|Superiority or Other|||||||0.744|||||||t-test, 2 sided||||
1676021|NCT01301079|3083406|Superiority or Other||Mean Difference (Final Values)|2.0||||0.485|2-Sided|95.0|||||t-test, 2 sided||||
1676022|NCT01301079|3083407|Superiority or Other|||||||0.598|||||||t-test, 2 sided||||
1676023|NCT01301079|3083408|Superiority or Other||||||<|0.872|||||||t-test, 2 sided||||
1676024|NCT01301079|3083409|Superiority or Other|||||||0.737|||||||t-test, 2 sided||||
1676025|NCT01301079|3083410|Superiority or Other|||||||0.909|||||||t-test, 2 sided||||
1676026|NCT01301079|3083411|Superiority or Other|||||||0.499|||||||t-test, 1 sided||||
1676027|NCT01301079|3083412|Superiority or Other|||||||0.386|||||||t-test, 2 sided||||
1676028|NCT01301079|3083413|Superiority or Other|||||||0.325|||||||t-test, 2 sided||||
1676040|NCT01301001|3083426|Superiority||Mean Difference (Final Values)|-0.1||||0.76|2-Sided|95.0|-0.9|0.6|||Mixed Models Analysis||||
1676041|NCT01301001|3083427|Superiority||Mean Difference (Final Values)|-0.3||||0.07|2-Sided|95.0|-0.7|0.0|||Mixed Models Analysis||||
1676042|NCT01300819|3083437|Superiority or Other||Mean Difference (Final Values)|-1.04||||0.043|2-Sided|95.0|-2.06|-0.03||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.|||
1676043|NCT01300819|3083438|Superiority or Other||Mean Difference (Final Values)|0.06||||0.889|2-Sided|95.0|-0.81|0.94||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.|||
1676044|NCT01300819|3083439|Superiority or Other||Mean Difference (Final Values)|0.38||||0.536|2-Sided|95.0|-0.84|1.6||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.|||
1676045|NCT01300819|3083440|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.584|2-Sided|95.0|-0.87|0.49||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.|||
1676046|NCT01300819|3083441|Superiority or Other||Mean Difference (Final Values)|0.0||||0.997|2-Sided|95.0|-0.99|0.99||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.|||
1676047|NCT01300819|3083442|Superiority or Other||Mean Difference (Final Values)|0.08||||0.601|2-Sided|95.0|-0.22|0.37||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.|||
1676048|NCT01300819|3083443|Superiority or Other||Mean Difference (Final Values)|-1.81||||0.047|2-Sided|95.0|-3.59|-0.02||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.|||
1676049|NCT01300819|3083444|Superiority or Other||Mean Difference (Final Values)|-1.06||||0.122|2-Sided|95.0|-2.41|0.29||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.|||
1676050|NCT01300819|3083445|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.773|2-Sided|95.0|-0.67|0.5||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.|||
1676051|NCT01300819|3083446|Superiority or Other||Mean Difference (Final Values)|-2.79||||0.024|2-Sided|95.0|-5.21|-0.37||Two-sided p-values are presented.|ANCOVA|Testing was performed using an ANCOVA model, adjusted for several terms.|||
1676052|NCT01300819|3083447|Superiority or Other||Mean Difference (Final Values)|-2.6||||0.002|2-Sided|95.0|-4.27|-0.92||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysis was performed with ANCOVA model, adjusted for several terms.|||
1676053|NCT01300819|3083448|Superiority or Other||Mean Difference (Final Values)|-3.58||||0.147|2-Sided|95.0|-8.43|1.26||Two-sided p-value is presented. No multiplicity adjustment is performed.|ANCOVA|Analysing was performed with ANCOVA model, adjusted for several terms.||Null hypothesis: mean change in the total Nonmotor Symptoms Scale (NMSS) score is the same for rotigotine- and placebo-treated group.|
1676054|NCT01300455|3083513|Superiority or Other||Mean Difference (Final Values)|-0.47|||||2-Sided|90.0|-3.2|2.26||||||Difference (Suvorexant - Placebo) of Least Squares Means|
1676055|NCT01300455|3083514|Superiority or Other||Median Difference (Final Values)|-0.18|||||2-Sided|90.0|-0.61|0.25||||||Day 4, Wake, Difference (Suvorexant - Placebo) of Least Squares Means|
1676056|NCT01300455|3083514|Superiority or Other||Median Difference (Final Values)|0.02|||||2-Sided|90.0|-0.4|0.43||||||Day 4, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means|
1676057|NCT01300455|3083514|Superiority or Other||Mean Difference (Final Values)|0.13|||||2-Sided|90.0|-0.24|0.5||||||Day 4, REM, Difference (Suvorexant - Placebo) of Least Squares Means|
1676058|NCT01300455|3083514|Superiority or Other||Mean Difference (Final Values)|-0.51|||||2-Sided|90.0|-1.13|0.1||||||Day 1, Wake, Difference (Suvorexant - Placebo) of Least Squares Means|
1676059|NCT01300455|3083514|Superiority or Other||Mean Difference (Final Values)|0.05|||||2-Sided|90.0|-0.41|0.5||||||Day 1, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means|
1676060|NCT01300455|3083514|Superiority or Other||Mean Difference (Final Values)|-0.06|||||2-Sided|90.0|-0.61|0.49||||||Day 1, REM, Difference (Suvorexant - Placebo) of Least Squares Means|
1676061|NCT01300455|3083515|Superiority or Other||Mean Difference (Final Values)|0.28|||||2-Sided|90.0|-0.09|0.65||||||Day 4, SaO2 <85%, Difference (Suvorexant - Placebo) of Least Squares Means|
1676062|NCT01300455|3083515|Superiority or Other||Mean Difference (Final Values)|0.21|||||2-Sided|90.0|-0.59|1.01||||||Day 4, SaO2 <90%, Difference (Suvorexant - Placebo) of Least Squares Means|
1676063|NCT01300455|3083515|Superiority or Other||Mean Difference (Final Values)|0.25|||||2-Sided|90.0|-0.1|0.59||||||Day 1, SaO2 <85%, Difference (Suvorexant - Placebo) of Least Squares Means|
1676064|NCT01300455|3083515|Superiority or Other||Mean Difference (Final Values)|0.74|||||2-Sided|90.0|-1.31|2.79||||||Day 1, SaO2 <90%, Difference (Suvorexant - Placebo) of Least Squares Means|
1676065|NCT01300455|3083516|Superiority or Other||Mean Difference (Final Values)|-0.06|||||2-Sided|90.0|-0.45|0.33||||||Day 4, Difference (Suvorexant - Placebo) of Least Squares Means|
1676066|NCT01300455|3083516|Superiority or Other||Mean Difference (Final Values)|-0.04|||||2-Sided|90.0|-0.49|0.42||||||Day 1, Difference (Suvorexant - Placebo) of Least Squares Means|
1676067|NCT01300455|3083519|Superiority or Other||Mean Difference (Final Values)|2.66|||||2-Sided|90.0|0.22|5.09||||||Difference (Suvorexant - Placebo) of Least Squares Means|
1676068|NCT01300351|3083522|Superiority or Other||Odds Ratio (OR)|1.37||||0.023|2-Sided|95.0|1.04|1.8|||Regression, Logistic||||
1676069|NCT01300351|3083523|Superiority or Other||Odds Ratio (OR)|1.44||||0.107|2-Sided|95.0|0.93|2.24|||Regression, Logistic||||
1676090|NCT01299909|3083577|Superiority||Mean Difference (Final Values)|6.09||||0.02|2-Sided||||||ANOVA|df=(1,57)|||
1676091|NCT01299909|3083578|Superiority||Mean Difference (Final Values)|4.81||||0.03|2-Sided||||||ANOVA|df=(1,57)|||
1676092|NCT01299909|3083579|Superiority or Other||Odds Ratio (OR)|1.53||||0.35|2-Sided|95.0|0.67|3.51|||Regression, Logistic||||
1676070|NCT01300351|3083524|Superiority or Other||Hazard Ratio (HR)|0.75||||0.078|2-Sided|95.0|0.54|1.03||With a sample size of 220 randomised patients and 150 progression events, if treatment effect is consistent between ethnicities/the study populations, there is an 89% chance the HR <1.|Log Rank|||The results of this study would be considered to be consistent with that of the CONFIRM study if the hazard ratio (HR) point estimate for the treatment comparison was <1 (ie, it favoured fulvestrant 500 mg), without the requirement for the benefit of fulvestrant 500 mg to be statistically significant.|
1676071|NCT01300260|3083532|Superiority or Other||Geometric least squares (LS) mean ratio|1.75|||<|0.001|2-Sided|95.0|1.59|1.94||P-value is 2-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.|||
1676072|NCT01300260|3083532|Superiority or Other||Geometric least squares (LS) mean ratio|1.43|||<|0.009|2-Sided|95.0|1.14|1.8||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.|||
1676073|NCT01300260|3083533|Superiority or Other||Geometric least squares (LS) mean ratio|1.39|||<|0.001|2-Sided|95.0|1.27|1.53||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.|||
1676074|NCT01300260|3083533|Superiority or Other||Geometric least squares (LS) mean ratio|1.22|||<|0.021|2-Sided|95.0|1.04|1.43||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.|||
1676075|NCT01300260|3083534|Superiority or Other||Geometric least squares (LS) mean ratio|2.44|||<|0.001|2-Sided|95.0|1.71|3.47||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.|||
1676076|NCT01300260|3083534|Superiority or Other||Geometric least squares (LS) mean ratio|2.04|||<|0.011|2-Sided|95.0|1.26|3.31||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.|||
1676077|NCT01300260|3083535|Superiority or Other||Geometric least squares (LS) mean ratio|3.78|||<|0.001|2-Sided|95.0|2.99|4.78||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.|||
1676078|NCT01300260|3083535|Superiority or Other||Geometric least squares (LS) mean ratio|4.15|||<|0.001|2-Sided|95.0|3.45|5.0||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.|||
1676079|NCT01300260|3083536|Superiority or Other||Geometric least squares (LS) mean ratio|7.92|||<|0.001|2-Sided|95.0|4.82|13.0||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.|||
1676080|NCT01300260|3083536|Superiority or Other||Geometric least squares (LS) mean ratio|3.09|||<|0.001|2-Sided|95.0|2.66|3.59||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.|||
1676081|NCT01300260|3083537|Superiority or Other||Geometric least squares (LS) means ratio|5.4|||<|0.001|2-Sided|95.0|4.09|7.13||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.|||
1676082|NCT01300260|3083537|Superiority or Other||Geometric least squares (LS) mean ratio|2.96|||<|0.001|2-Sided|95.0|2.41|3.64||P-value is two-sided.|Mixed Models Analysis|The mixed model analysis included treatment, period, and sequence as fixed effects and participant nested in sequence as a random effect.|||
1676083|NCT01300234|3083565|Superiority or Other||percentage of participants|25.6|||<|0.0001|2-Sided|97.5|16.7|34.3||HBeAg-negative participants|Roche COBAS Taqman HBV test||"A non-completers equal failures approach was used for the primary analysis. The estimated value represents the difference between the percentage of participants achieving HBV DNA <400 copies/mL at Week 48 in the TDF group and the ADV group."||
1676084|NCT01300234|3083565|Superiority or Other||percentage of participants|58.5|||<|0.0001|2-Sided|97.5|45.8|71.3||HBeAg-positive participants|Roche COBAS Taqman HBV test||"A non-completers equal failures approach is used for the primary analysis. The estimated value represents the difference between the percentage of participants achieving HBV DNA <400 copies/mL at Week 48 in the TDF group and the ADV group."||
1676085|NCT01300052|3083572|Superiority or Other||Difference in Percentage|3.8|||||2-Sided|95.0|-14.3|21.8||||||Difference in percentage was calculated as values of AN2728 Ointment, 2% group minus values of AN2728 Ointment, Vehicle group.|
1676086|NCT01299961|3083573|Superiority or Other||Mean Difference (Final Values)|1.2|Standard Deviation|3.7||0.19|2-Sided||||||t-test, 2 sided|||7 joints were scanned by grey-scale ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. GSUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total GSUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline GSUS minus 12 month GSUS.|
1676087|NCT01299961|3083574|Superiority or Other||Mean Difference (Final Values)|3.0|Standard Deviation|3.7|<|0.01|2-Sided||||||t-test, 2 sided|||7 joints were scanned by power doppler ultra sound of the most affected side: wrist, MCP 2/3, PIP 2/3, and MTP 2/5. PDUS was scored semi-quantitatively on a scale of 0-3 (higher score is worse). The mean score of the 2-3 views obtained for each joint was added across all 7 joints, and the total PDUS (range 0-21) scores were calculated. The change from baseline to 12 months is calculated as the baseline PDUS minus 12 month PDUS.|
1676088|NCT01299961|3083575|Superiority or Other||Mean Difference (Final Values)|11.4|Standard Deviation|13.1|<|0.01|2-Sided||||||t-test, 2 sided|||Most involved side: Synovitis (S), tenosynovitis (T), and power Doppler (PD) of wrist (dorsal (D), palmar (P), and ulnar (U)); S and T of MCP 2,3 (P, plus D for T); PD of the MCP joints (P and D); S and PD of PIP 2, 3 (P, plus D for PD); S and PD for MTP 2, 4 (D). S and PD graded from 0 to 3, and max individual scores are 27 and 39, respectively. T graded on 0-1 scale; max T score is 5. High score is worse. The 7-joint US score is sum of T, S, and PD scores. Change calculated baseline- month 12.|
1676093|NCT01299766|3083593|Superiority||Difference in Slopes|2.47||||0.064|2-Sided|95.0|-0.14|5.07|||Mixed Models Analysis|||Mixed effects linear regression was used to model the trajectory. Fixed effects for time (as a continuous variable), treatment group, time-by-treatment group interaction, and age at baseline were included. Random intercepts and slopes were included to account for within-subject correlation.|
1676094|NCT01299766|3083594|Superiority||Risk Ratio (RR)|0.12||||0.02|2-Sided|95.0|0.02|0.74|||Poisson regression with robust SE (GEE)|||Poisson regression with robust standard errors (GEE) was used to jointly model decline in HVLT-R Total Recall score ≥ 6 words at 6, 12, 18, and 24 months by treatment group. The model included time, treatment, time-by-treatment interaction terms, and baseline HVLT-R Total Recall score.|
1676095|NCT01299610|3083617|Superiority or Other||Difference in Adjusted Means|-1.39|Standard Error of the Mean|0.492||0.006|2-Sided|95.0|-2.37|-0.4|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 14|
1676096|NCT01299610|3083617|Superiority or Other||Difference in Adjusted Means|-0.65|Standard Error of the Mean|0.479||0.18|2-Sided|95.0|-1.61|0.31|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 14|
1676097|NCT01299610|3083617|Superiority or Other||Difference in Adjusted Means|-0.24|Standard Error of the Mean|0.462||0.602|2-Sided|95.0|-1.17|0.68|||Mixed model repeated measures|||GW870086, 0.2% cream, Placebo: Day 14|
1676098|NCT01299610|3083617|Superiority or Other||Difference in Adjusted Means|-1.29|Standard Error of the Mean|0.485||0.01|2-Sided|95.0|-2.26|-0.32|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 7|
1676099|NCT01299610|3083617|Superiority or Other||Difference in Adjusted Means|-0.6|Standard Error of the Mean|0.472||0.212|2-Sided|95.0|-1.54|0.35|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 7|
1676100|NCT01299610|3083617|Superiority or Other||Difference in Adjusted Means|-0.24|Standard Error of the Mean|0.456||0.601|2-Sided|95.0|-1.15|0.67|||Mixed model repeated measures|||GW870086, 0.2% cream, Placebo: Day 7|
1676101|NCT01299610|3083617|Superiority or Other||Difference in Adjusted Means|-0.28|Standard Error of the Mean|0.323||0.386|2-Sided|95.0|-0.93|0.36|||Mixed model repeated measures|||Placebo, FP, 0.05% cream: Day 3|
1676102|NCT01299610|3083617|Superiority or Other||Difference in Adjusted Means|0.14|Standard Error of the Mean|0.314||0.657|2-Sided|95.0|-0.49|0.77|||Mixed model repeated measures|||GW870086, 2.0% cream, Placebo: Day 3|
1676103|NCT01299610|3083617|Superiority or Other||Difference in Adjusted Means|0.03|Standard Error of the Mean|0.302||0.923|2-Sided|95.0|-0.58|0.63|||Mixed model repeated measures|||GW870086 0.2% cream Vs Placebo: Day 3|
1676104|NCT01299610|3083617|Superiority or Other||Difference in Adjusted Means|-0.17|Standard Error of the Mean|0.174||0.336||95.0|-0.52|0.18|||Mixed model repeated measures|||FP, 0.05% cream Vs Placebo: Day 2|
1676105|NCT01299610|3083617|Superiority or Other||Difference in Adjusted Means|-0.08|Standard Error of the Mean|0.169||0.655|2-Sided|95.0|-0.42|0.27|||Mixed model repeated measures|||GW870086, 2.0% cream Vs Placebo: Day 2|
1676106|NCT01299610|3083617|Superiority or Other||Difference in Adjusted Means|0.09|Standard Error of the Mean|0.16||0.581|2-Sided|95.0|-0.24|0.42|||Mixed model repeated measures|||GW870086, 0.2% cream Vs Placebo: Day 2|
1676107|NCT01299610|3083618|Superiority or Other||Difference in Adjusted Means|-1.51|Standard Error of the Mean|0.572||0.011|2-Sided|95.0|-2.65|-0.36|||Mixed model for repeated measures||||
1676108|NCT01299610|3083618|Superiority or Other||mixed model for repeated measures|-0.89|Standard Error of the Mean|0.557||0.118|2-Sided|95.0|-2.0|0.23|||Mixed model for repeated measures||||
1676109|NCT01299610|3083618|Superiority or Other||Difference in Adjusted Means|-0.38|Standard Error of the Mean|0.538||0.48|2-Sided|95.0|-1.46|0.7|||Mixed model for repeated measures||||
1676110|NCT01299571|3083625|Superiority or Other||Percentage of participants|3.8||||||95.0|3.2|4.4|||||The estimated value represents the percentage of participants with adverse events.||
1676111|NCT01299480|3083630|Superiority or Other||||||<|0.001|||||||Binomial Distribution|||PMB2707 [B44]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant.|
1676112|NCT01299480|3083630|Superiority or Other||||||<|0.001|||||||Binomial Distribution|||PMB2948 [B24]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant.|
1676113|NCT01299480|3083630|Superiority or Other||||||<|0.001|||||||Binomial Distribution|||PMB2001 [A56]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant.|
1676114|NCT01299480|3083630|Superiority or Other||||||<|0.001|||||||Binomial Distribution|||PMB80 [A22]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant.|
1676115|NCT01299480|3083632|Superiority or Other||||||<|0.001|||||||Binomial Distribution|||PMB2707 [B44]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant.|
1676116|NCT01299480|3083632|Superiority or Other||||||<|0.001|||||||Binomial Distribution|||PMB2948 [B24]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant.|
1676117|NCT01299480|3083632|Superiority or Other||||||<|0.001|||||||Binomial Distribution|||PMB2001 [A56]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant.|
1676118|NCT01299480|3083632|Superiority or Other||||||<|0.001|||||||Binomial Distribution|||PMB80 [A22]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant.|
1676119|NCT01299480|3083632|Superiority or Other||||||<|0.001|||||||Binomial Distribution|||PMB2707 [B44]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant.|
1676120|NCT01299480|3083632|Superiority or Other||||||<|0.001|||||||Binomial Distribution|||PMB2948 [B24]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant.|
1676121|NCT01299480|3083632|Superiority or Other||||||<|0.001|||||||Binomial Distribution|||PMB2001 [A56]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant.|
1676348|NCT01294319|3084380|Superiority|||||||0.2786|||||||t-test, 2 sided||||
1676122|NCT01299480|3083632|Superiority or Other||||||<|0.001|||||||Binomial Distribution|||PMB80 [A22]: Response rate was compared with 50%, using 1-sided exact test based on binomial distribution. p-Value <0.0125 was considered significant.|
1676123|NCT01299454|3083643|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.314|||||2-Sided|90.0|0.195|0.507||||||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676124|NCT01299454|3083643|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.516|||||2-Sided|90.0|0.341|0.781||||||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676125|NCT01299454|3083643|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.558|||||2-Sided|90.0|0.368|0.845||||||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676126|NCT01299454|3083644|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.561|||||2-Sided|90.0|0.308|1.022||||||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676127|NCT01299454|3083644|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.594|||||2-Sided|90.0|0.378|0.934||||||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676128|NCT01299454|3083644|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.716|||||2-Sided|90.0|0.445|1.153||||||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676129|NCT01299454|3083645|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.334|||||2-Sided|90.0|0.214|0.521|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676130|NCT01299454|3083645|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.586|||||2-Sided|90.0|0.399|0.861|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676131|NCT01299454|3083645|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.509|||||2-Sided|90.0|0.346|0.748||||||The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676349|NCT01294319|3084381|Superiority|||||||0.4872|||||||Fisher Exact||||
1676426|NCT01292226|3084554|Superiority or Other|||||||0.3862||||||IMPDH II, time 0 [trough]|ANOVA||||
1676132|NCT01299454|3083654|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.451|||||2-Sided|90.0|0.352|0.577|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676133|NCT01299454|3083654|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.742|||||2-Sided|90.0|0.599|0.918|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676134|NCT01299454|3083654|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric mean ratio|0.856|||||2-Sided|90.0|0.691|1.059|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676135|NCT01299454|3083655|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.077|||||2-Sided|90.0|0.54|2.146|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676136|NCT01299454|3083655|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance|Geometric Mean Ratio|1.604|||||2-Sided|90.0|0.942|2.732|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676137|NCT01299454|3083655|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.241|||||2-Sided|90.0|0.719|2.143|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676138|NCT01299454|3083656|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.79|||||2-Sided|90.0|0.524|1.189|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676139|NCT01299454|3083656|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.199|||||2-Sided|90.0|0.841|1.71|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676170|NCT01298544|3083790|Superiority or Other||Difference in proportions|30.0|||||2-Sided|95.0|17.9|41.5|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.|Serotype 18C|
1676140|NCT01299454|3083656|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.103|||||2-Sided|90.0|0.774|1.573|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The secondary comparisons were each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the secondary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676141|NCT01299454|3083657|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.531||||||90.0|0.399|0.705|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance|
1676142|NCT01299454|3083657|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.85|||||2-Sided|90.0|0.665|1.087|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance|
1676143|NCT01299454|3083657|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.904|||||2-Sided|90.0|0.707|1.156|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance|
1676144|NCT01299454|3083658|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometic Mean Ratio|1.041|||||2-Sided|90.0|0.506|2.142|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance|
1676145|NCT01299454|3083658|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.727|||||2-Sided|90.0|0.977|3.052|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676146|NCT01299454|3083658|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometic Mean Ratio|1.255|||||2-Sided|90.0|0.702|2.244|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676147|NCT01299454|3083659|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|0.929|||||2-Sided|90.0|0.581|1.488|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676171|NCT01298544|3083790|Superiority or Other||Difference in proportions|29.7|||||2-Sided|95.0|19.4|40.5|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.|Serotype 14|
1676428|NCT01292226|3084554|Superiority or Other|||||||0.6847||||||IMPDH I, time 0 [trough]|ANOVA||||
1676148|NCT01299454|3083659|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.375|||||2-Sided|90.0|0.915|2.066|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% CI for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676149|NCT01299454|3083659|Non-Inferiority or Equivalence|Bioequivalence was claimed for a PK parameter if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0]. Due to the nature of the normal-theory CIs, this approach was equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|Geometric Mean Ratio|1.166|||||2-Sided|90.0|0.776|1.751|||||Due to the nature of the normal-theory CIs, this approach is equivalent to carrying out two 1-sided tests of hypothesis at the 5% level of significance.|The primary comparison was each hepatic disease group (mild, moderate or severe) versus the control (normal group). To compare the primary PK parameters between each hepatic disease group and the control group, the 90% confidence interval (CI) for the difference in the means of the log-transformed data was calculated using a mixed effect analysis of variance.|
1676150|NCT01299389|3083660|Superiority or Other||LS Mean difference|-4.6|Standard Error of the Mean|1.17|<|0.0001|2-Sided|95.0|-6.9|-2.3|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.|
1676151|NCT01299389|3083661|Superiority or Other||LS Mean difference|-2.8|Standard Error of the Mean|0.67|<|0.0001|2-Sided|95.0|-4.1|-1.5|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.|
1676152|NCT01299389|3083662|Superiority or Other||LS Mean difference|-2.1|Standard Error of the Mean|0.59||0.0003|2-Sided|95.0|-3.3|-1.0|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.|
1676153|NCT01299389|3083663|Superiority or Other||LS Mean difference|-1.1|Standard Error of the Mean|0.37||0.0025|2-Sided|95.0|-1.9|-0.4|||ANCOVA|||Anxiety/depression (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.|
1676154|NCT01299389|3083663|Superiority or Other||LS Mean difference|-1.4|Standard Error of the Mean|0.45||0.0023|2-Sided|95.0|-2.3|-0.5|||ANCOVA|||Uncontrolled hostility/excitement (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.|
1676155|NCT01299389|3083663|Superiority or Other||LS Mean difference|-2.2|Standard Error of the Mean|0.57|<|0.0001|2-Sided|95.0|-3.4|-1.1|||ANCOVA|||Disorganized thoughts (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.|
1676156|NCT01299389|3083663|Superiority or Other||LS Mean difference|-2.0|Standard Error of the Mean|0.61|<|0.0012|2-Sided|95.0|-3.2|-0.8|||ANCOVA|||Negative symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.|
1676157|NCT01299389|3083663|Superiority or Other||LS Mean difference|-2.7|Standard Error of the Mean|0.69|<|0.0001|2-Sided|95.0|-4.1|-1.4|||ANCOVA|||Positive symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.|
1676158|NCT01299389|3083666|Superiority or Other||Least squares (LS) means difference|-9.7|Standard Error of the Mean|2.19|<|0.0001|2-Sided|95.0|-14.0|-5.4|||ANCOVA|||Change at Week 13 or Early Discontinuation: P value were calculated using an analysis of covariance (ANCOVA) model with treatment and country as factors and baseline PANSS total score as a covariate.|
1676159|NCT01299376|3083667|Superiority or Other||Difference in Least Squares Means|-10.3|||<|0.001|2-Sided|95.0|-12.8|-7.7||Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.|Constrained Longitudinal Data Analysis||||
1676160|NCT01299376|3083678|Superiority or Other||Difference in Least-squares Means|-5.9|||<|0.001|2-Sided|95.0|-7.5|-4.2|||Contrained Longitudinal Data Analysis|Model including treatment, time and the interaction of time by treatment with a restriction of the same baseline mean across treatment groups.|||
1676161|NCT01299272|3083716|Superiority or Other|||||||0.485|||||||Log Rank||||
1676162|NCT01299025|3083733|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1676163|NCT01298778|3083743|Superiority or Other|||||||0.05|||||||t-test, 2 sided|||acute pain scores with movement at 24 hours|
1676164|NCT01298700|3083750|Superiority or Other||Mean Difference (Final Values)|-4.7||||0.148|2-Sided|95.0|-11.0|1.9||P-value was stratified by baseline prostaglandin analogue (PGA) treatment(yes/no) and by baseline active ocular surface finding (present/absent).|Cochran-Mantel-Haenszel||bimatoprost 0.01% ophthalmic solution - bimatoprost 0.03% ophthalmic solution||
1676165|NCT01298648|3083777|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|Paired t-test using observed values at Baseline and Week 24.|||
1676166|NCT01298648|3083778|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided|Paired t-test using observed values at Baseline and Week 8.|||
1676167|NCT01298648|3083780|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|Paired t-test using observed cases at Baseline and Week 4.|||
1676168|NCT01298544|3083790|Superiority or Other||Difference in proportions|6.2|||||2-Sided|95.0|1.8|13.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.|Serotype 23F|
1676169|NCT01298544|3083790|Superiority or Other||Difference in proportions|6.5|||||2-Sided|95.0|1.2|13.9|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.|Serotype 19F|
1676427|NCT01292226|3084554|Superiority or Other|||||||0.3184||||||IMPDH I, time 120 [2 hours after administration at Week 12]|ANOVA||||
1676172|NCT01298544|3083790|Superiority or Other||Difference in proportions|10.3|||||2-Sided|95.0|1.9|19.6|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.|Serotype 9V|
1676173|NCT01298544|3083790|Superiority or Other||Difference in proportions|2.2|||||2-Sided|95.0|-0.011|7.715|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.|Serotype 6B|
1676174|NCT01298544|3083790|Superiority or Other||Difference in proportions|25.0|||||2-Sided|95.0|12.7|37.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 1 and 2 combined–Group 3), expressed as a percentage.|Serotype 4|
1676175|NCT01298544|3083790|Superiority or Other||Difference in proportions|-0.8|||||2-Sided|95.0|-4.5|2.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.|Serotype 23F|
1676176|NCT01298544|3083790|Superiority or Other||Difference in proportions|-2.5|||||2-Sided|95.0|-7.1|0.6|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.|Serotype 19F|
1676177|NCT01298544|3083790|Superiority or Other||Difference in proportions|-11.9|||||2-Sided|95.0|-22.7|-1.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.|Serotype 18C|
1676178|NCT01298544|3083790|Superiority or Other||Difference in proportions|-3.4|||||2-Sided|95.0|-10.3|3.1|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.|Serotype 14|
1676179|NCT01298544|3083790|Superiority or Other||Difference in proportions|0.7|||||2-Sided|95.0|-5.9|7.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.|Serotype 9V|
1676180|NCT01298544|3083790|Superiority or Other||Difference in proportions|0.0|||||2-Sided|95.0|-3.1|3.0|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.|Serotype 6B|
1676181|NCT01298544|3083790|Superiority or Other||Difference in proportions|-18.5|||||2-Sided|95.0|-29.4|-7.3|||||Difference in proportions, expressed as a percentage. Exact 2 sided CI for the difference in proportions (Group 2–Group 1), expressed as a percentage.|Serotype 4|
1676182|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|2.08|||||2-Sided|95.0|1.65|2.63|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 23F|
1676183|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|4.47|||||2-Sided|95.0|3.29|6.07|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 19F|
1676184|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|2.34|||||2-Sided|95.0|1.68|3.24|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 18C|
1676185|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|6.66|||||2-Sided|95.0|4.53|9.79|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 14|
1676186|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|1.26|||||2-Sided|95.0|0.98|1.62|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 9V|
1676187|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|3.04|||||2-Sided|95.0|2.41|3.84|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 6B|
1676188|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|1.97|||||2-Sided|95.0|1.39|2.8|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3).|Serotype 4|
1676189|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|0.82|||||2-Sided|95.0|0.64|1.05|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 23F|
1676190|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|0.56|||||2-Sided|95.0|0.4|0.77|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 19F|
1676191|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|0.96|||||2-Sided|95.0|0.7|1.31|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 18C|
1676192|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|0.67|||||2-Sided|95.0|0.45|1.01|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 14|
1676193|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|0.95|||||2-Sided|95.0|0.74|1.23|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 9V|
1676423|NCT01292226|3084554|Superiority or Other|||||||0.963||||||IMPDH activity, time 120 [2 hours after administration at Week 12]|ANOVA||||
1676194|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|0.81|||||2-Sided|95.0|0.64|1.04|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 6B|
1676195|NCT01298544|3083791|Superiority or Other||Ratio of GMCs|0.68|||||2-Sided|95.0|0.48|0.94|||||Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1).|Serotype 4|
1676196|NCT01298531|3083793|Superiority or Other||Mean Difference (Final Values)|0.68||||0.0422|2-Sided|95.0|0.02|1.34|||ANCOVA|||ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.|
1676197|NCT01298531|3083794|Superiority or Other||Mean Difference (Final Values)|2.41||||0.2735|2-Sided|95.0|-1.94|6.75|||ANCOVA|||ANCOVA model on change from baseline in chest expansion mobility score fitting baseline chest expansion mobility score as a covariate, plus treatment as a factor.|
1676198|NCT01298531|3083800|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.2967|2-Sided|95.0|-0.86|0.27|||ANCOVA|||ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factor|
1676199|NCT01298531|3083801|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.1601|2-Sided|95.0|-0.87|0.15|||ANCOVA|||ANCOVA model on change from baseline BASMI score fitting baseline BASMI score as a covariate, plus treatment as a factor|
1676200|NCT01298531|3083803|Superiority or Other||Odds Ratio (OR)|2.47||||0.0498|2-Sided|95.0|1.0|6.08|||Regression, Logistic|||Logistic regression with baseline morning stiffness score and treatment group included as covariates. Week 8 was analyzed using a logistic regression to assess treatment effect.|
1676201|NCT01298531|3083806|Superiority or Other||Odds Ratio (OR)|2.01||||0.126|2-Sided|95.0|0.822|4.901|||Regression, Logistic|||Week 8 was analyzed using logistic regression with baseline score and treatment group included as covariates.|
1676202|NCT01298531|3083815|Superiority or Other||Mean Difference (Final Values)|-1.12||||0.0233|2-Sided|95.0|-2.07|-0.16|||ANCOVA|||ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factor.|
1676203|NCT01298531|3083816|Superiority or Other||Mean Difference (Final Values)|-1.34||||0.0017|2-Sided|95.0|-2.16|-0.52|||ANCOVA|||ANCOVA model on change from baseline PGA score fitting baseline PGA score as a covariate, plus treatment as a factor|
1676204|NCT01298531|3083818|Superiority or Other||Mean Difference (Final Values)|-1.15||||0.0344|2-Sided|95.0|-2.22|-0.09|||ANCOVA|||ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.|
1676205|NCT01298531|3083819|Superiority or Other||Mean Difference (Final Values)|-1.16||||0.0152|2-Sided|95.0|-2.09|-0.23|||ANCOVA|||ANCOVA model on change from each baseline BASDAI component score fitting each baseline component score as a covariate, plus treatment as a factor.|
1676206|NCT01298531|3083820|Superiority or Other||Mean Difference (Final Values)|-0.91||||0.0297|2-Sided|95.0|-1.74|-0.09|||ANCOVA|||ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.|
1676207|NCT01298531|3083821|Superiority or Other||Mean Difference (Final Values)|-0.81||||0.0237|2-Sided|95.0|-1.5|-0.11|||ANCOVA|||ANCOVA model on change from baseline BASFI score fitting baseline BASFI score as a covariate, plus treatment as a factor.|
1676208|NCT01298531|3083823|Superiority or Other||Mean Difference (Final Values)|-1.51||||0.0132|2-Sided|95.0|-2.69|-0.32|||ANCOVA|||ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factor|
1676209|NCT01298531|3083824|Superiority or Other||Mean Difference (Final Values)|-1.31||||0.0198|2-Sided|95.0|-2.4|-0.21|||ANCOVA|||ANCOVA model on change from baseline nocturnal back pain fitting baseline nocturnal back pain as a covariate, plus treatment as a factor|
1676210|NCT01298531|3083826|Superiority or Other||Mean Difference (Final Values)|-1.28||||0.0212|2-Sided|95.0|-2.36|-0.2|||ANCOVA|||ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factor|
1676211|NCT01298531|3083827|Superiority or Other||Mean Difference (Final Values)|-1.01||||0.0474|2-Sided|95.0|-2.0|-0.01|||ANCOVA|||ANCOVA model on change from baseline total back pain fitting baseline total back pain as a covariate, plus treatment as a factor.|
1676212|NCT01298531|3083829|Superiority or Other||Mean Difference (Final Values)|-1.24||||0.0256|2-Sided|95.0|-2.33|-0.16|||ANCOVA|||ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.|
1676213|NCT01298531|3083830|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.005|2-Sided|95.0|-2.2|-0.4|||ANCOVA|||ANCOVA model on change from baseline BAS-G score fitting baseline BAS-G score as a covariate, plus treatment as a factor.|
1676214|NCT01298531|3083834|Superiority or Other||Mean Difference (Final Values)|-0.67||||0.0037|2-Sided|95.0|-1.11|-0.22|||ANCOVA|||ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.|
1676215|NCT01298531|3083835|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.0011|2-Sided|95.0|-0.9|-0.24|||ANCOVA|||ANCOVA model on change from baseline ASDAS ESR score fitting baseline ASDAS ESR score as a covariate, plus treatment as a factor.|
1676216|NCT01298531|3083837|Superiority or Other||Mean Difference (Final Values)|-0.68||||0.0011|2-Sided|95.0|-1.09|-0.28|||ANCOVA|||ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.|
1676217|NCT01298531|3083838|Superiority or Other||Mean Difference (Final Values)|-0.78|||<|0.0001|2-Sided|95.0|-1.11|-0.44|||ANCOVA|||ANCOVA model on change from baseline ASDAS CRP score fitting baseline ASDAS CRP score as a covariate, plus treatment as a factor.|
1676218|NCT01298531|3083839|Superiority or Other||Odds Ratio (OR)|2.13||||0.3291|2-Sided|95.0|0.47|9.72|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.|
1676312|NCT01294644|3084301|Superiority or Other||LS Mean Difference|-0.97||||0.04|2-Sided|95.0|-1.89|-0.05|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit*treatment interaction, and the Baseline values as covariate.|||
1676219|NCT01298531|3083841|Superiority or Other||Odds Ratio (OR)|3.103||||0.0284|2-Sided|95.0|1.13|8.54|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.|
1676220|NCT01298531|3083843|Superiority or Other||Odds Ratio (OR)|2.696||||0.0501|2-Sided|95.0|1.0|7.27|||Regression, Logistic|||Week 8 was analyzed using a logistic regression to assess treatment effect. Logistic regression with baseline morning stiffness score and treatment group included as covariates.|
1676221|NCT01298531|3083846|Superiority or Other||Odds Ratio (OR)|2.963||||0.0324|2-Sided|95.0|1.1|8.01|||Regression, Logistic|||Logistic regression with baseline morning stiffness score and treatment group included as covariates.|
1676222|NCT01298531|3083847|Superiority or Other||Mean Difference (Final Values)|-53.7||||0.0053|2-Sided|95.0|-91.01|-16.38|||ANCOVA|||The changes from baseline in the continuous endpoints of mini BASDAI was analyzed using ANCOVA. The total NSAID score for the first 8 weeks of randomized treatment was calculated as an AUC using the linear trapezoidal rule.|
1676223|NCT01298531|3083848|Superiority or Other||Odds Ratio (OR)|0.209||||0.0066|2-Sided|95.0|0.07|0.65|||Regression, Logistic|||Logistic regression with baseline score and treatment group included as covariates.|
1676224|NCT01298531|3083850|Superiority or Other||Mean Difference (Final Values)|-0.88||||0.051|2-Sided|95.0|-1.76|0.0|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 8.|
1676225|NCT01298531|3083851|Superiority or Other||Mean Difference (Final Values)|-0.93||||0.0153|2-Sided|95.0|-1.68|-0.18|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model as detailed for the primary endpoint and using the repeated measures for the changes from Baseline in each outcome at Week 4.|
1676226|NCT01298531|3083852|Superiority or Other||Mean Difference (Final Values)|-19.78||||0.0115|2-Sided|95.0|-34.99|-4.57|||ANCOVA|||The analysis of secondary endpoints was an ANCOVA using linear regression with Baseline NSAID score and MMRM was run using the model and using the repeated measures for the changes from Baseline in each outcome at Week 8.|
1676227|NCT01298531|3083853|Superiority or Other||Mean Difference (Final Values)|-27.27||||0.0019|2-Sided|95.0|-44.17|-10.38|||ANCOVA|Not specifed.||The primary analysis of the primary endpoint was an Analysis of covariance (ANCOVA)with Baseline NSAID score and treatment as explanatory variables. The hypothesis tested for the primary endpoint was as follows: H0: ΔETN = ΔPlacebo; H1: ΔETN ≠ ΔPlacebo.|
1676228|NCT01298323|3083881|Superiority or Other (legacy)||t-Statistic|1.29||||0.199|2-Sided|95.0|-3.44|16.37||Statistical significance threshold at this analysis was 10%|t-test, 2 sided||||
1676229|NCT01298063|3083906|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|94.49|Standard Deviation|32.4||0.1546|2-Sided|90.0|71.563|124.764||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation||
1676230|NCT01298063|3083906|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|90.61|Standard Deviation|32.8||0.2309|2-Sided|90.0|66.915|122.705||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation||
1676231|NCT01298063|3083907|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|126.89|Standard Deviation|42.8||0.5281|2-Sided|90.0|86.028|187.159||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation||
1676232|NCT01298063|3083907|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|109.47|Standard Deviation|30.3||0.2002|2-Sided|90.0|82.683|144.947||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation||
1676233|NCT01298063|3083908|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|94.88|Standard Deviation|31.6||0.144|2-Sided|90.0|72.278|124.549||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation||
1676234|NCT01298063|3083908|Non-Inferiority or Equivalence|Relative bioavailability|Geometric mean ratio|92.64|Standard Deviation|33.6||0.1998|2-Sided|90.0|67.96|126.27||P-value for ratio outside interval 80 - 125 percent|ANOVA|Adjusted (by treatment) geometric mean ratio|The standard deviation is actually the intra individual geometric coefficient of variation||
1676235|NCT01297985|3083909|Superiority||MIXREG Estimate|0.042|Standard Error of the Mean|0.018||0.017|2-Sided||||||Mixed Effects Random Regression||||
1676236|NCT01297985|3083910|Superiority||MIXREG Estimate|0.12|Standard Error of the Mean|0.04|<|0.01|2-Sided||||||Mixed Effects Random Regression|||This analysis Mixed Effects Random Regression Modeling to test whether self-advocacy scores changed overtime by study condition status. Reported below are findings for the self-advocacy assertiveness sub scale.|
1676237|NCT01297985|3083911|Superiority||MIXREG Estimate|0.33|Standard Error of the Mean|0.012|<|0.01|2-Sided||||||Mixed Effects Random Regression|||This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in Hopefulness that would be maintained longitudinally|
1676238|NCT01297985|3083912|Superiority||MIXREG Estimate|0.03|Standard Error of the Mean|0.01||0.022|2-Sided||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this third model included the general symptom distress as moderator||"We tested 3 moderating variables: BSI depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes general symptom distress as the moderator (high symptom distress X time X study condition)"|
1676313|NCT01294644|3084301|Superiority or Other||LS Mean Difference|-0.8||||0.09|2-Sided|95.0|-1.72|0.13|||Mixed Models Repeated Measures|The model includes the fixed effect factors visit and treatment, the visit*treatment interaction, and the Baseline values as covariate.|||
1676239|NCT01297985|3083912|Superiority||MIXREG Estimate|0.04|Standard Error of the Mean|0.02||0.01|2-Sided||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this second model included anxiety symptoms as moderator||"We tested 3 moderating variables: depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes anxiety as the moderator (high anxiety X time X study condition)"|
1676240|NCT01297985|3083912|Superiority||MIXREG Estimate|0.04|Standard Error of the Mean|0.02||0.01|2-Sided||||||Mixed Effects Random Regression|This analysis used Random Regression Modeling; this first model included depressive symptoms as moderator||"We tested 3 moderating variables: BSI depressive symptom, anxiety, and general symptom distress. In these three models, we hypothesized that the intervention participants with high levels of each type of symptoms would experience greater gains in empowerment over time than participants with low levels of symptoms, as well as control participants with both high and low symptom level.~This model includes depressive symptoms as the moderator (High depressive symptoms X time X study condition)"|
1676241|NCT01297985|3083913|Superiority||MIXREG Estimate|1.55|Standard Error of the Mean|0.62||0.013|2-Sided||||||Mixed Effects Random Regression|||"This mixed effects random regression analysis tested whether intervention participants would report larger increases than controls in self-perceived Recovery and that this effect would be maintained overtime; and that intervention participants would report greater increases in hopefulness than controls, also maintained longitudinally~This first model reports on Recovery over time."|
1676242|NCT01297595|3083925|Superiority or Other||Ratio of Adjusted Means|96.84|||||2-Sided|90.0|88.22|106.32||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.|
1676243|NCT01297595|3083926|Superiority or Other||Ratio of Adjusted Means|99.35|||||2-Sided|90.0|90.51|109.07||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.|
1676244|NCT01297595|3083928|Superiority or Other||Ratio of Adjusted Means|99.58|||||2-Sided|90.0|91.08|108.87||||||Natural log transformed AUC (0 - ∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as a fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. This was an estimation study and there was no formal statistical hypothesis.|
1676245|NCT01297465|3083956|Superiority or Other||Mean Difference (Final Values)|-1.28|Standard Error of the Mean|0.947|||2-Sided|95.0|-3.15|0.59|||||The primary efficacy variable was to be analyzed using an analysis of variance (ANOVA) model, adjusted for treatment and country.|The null hypothesis was that the difference between the mean number of oocytes is less than (-3) or greater than (+3) between the two treatment arm. The alternate hypothesis was that the difference is between (-3) and (+3). The study had 80% power to show that the group randomized to Pergoveris® has an absolute difference of no more than 3 oocytes retrieved in comparison to the group randomized to GONAL-f®/Pergoveris®|
1676246|NCT01297348|3083957|Superiority or Other||Odds Ratio (OR)|2.53|||||2-Sided|95.0|0.98|6.54||||||Current user, case and matched control: Odds ratio (Lybrel/Levo-20) and 95% CI were estimated using conditional logistic regression, conditional on matching factors (age, calendar time, exposure status and database).|
1676247|NCT01297348|3083957|Superiority or Other||Odds Ratio (OR)|1.51|||||2-Sided|95.0|0.85|2.67||||||Current user, case and matched control: Odds ratio (Lybrel/EE-20) and 95% CI were estimated using conditional logistic regression, conditional on matching factors (age, calendar time, exposure status and database).|
1676248|NCT01297348|3083958|Superiority or Other||Incidence rate ratio|3.07|||||2-Sided|95.0|0.34|27.47||||||Incidence rate ratio (Lybrel/Levo-20) along with corresponding 95% CI was reported for past users.|
1676249|NCT01297348|3083958|Superiority or Other||Incidence rate ratio|3.49|||||2-Sided|95.0|2.02|6.02||||||Incidence rate ratio (Lybrel/Levo-20) along with corresponding 95% CI was reported for current users.|
1676250|NCT01297348|3083958|Superiority or Other||Incidence rate ratio|2.99|||||2-Sided|95.0|0.39|22.8||||||Incidence rate ratio (Lybrel/EE-20) along with corresponding 95% CI was reported for past users.|
1676251|NCT01297348|3083958|Superiority or Other||Incidence rate ratio|2.01|||||2-Sided|95.0|1.23|3.29||||||Incidence rate ratio (Lybrel/EE-20) along with corresponding 95 percent (%) confidence interval (CI) was reported for current users.|
1676252|NCT01297270|3083999|Superiority or Other||Mean Difference (Final Values)|16.6||||0.0014|2-Sided|95.0|6.5|26.7|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction||
1676253|NCT01297270|3083999|Superiority or Other||Mean Difference (Final Values)|20.7|||<|0.0001|2-Sided|95.0|10.7|30.6|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction||
1676254|NCT01297270|3084000|Superiority or Other||Mean Difference (Final Values)|17.4||||0.0007|2-Sided|95.0|7.3|27.4|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction||
1676255|NCT01297270|3084000|Superiority or Other||Mean Difference (Final Values)|20.7|||<|0.0001|2-Sided|95.0|10.7|30.6|||Cochran-Mantel-Haenszel||Estimate adjusted for genotype and race using Koch's method, with continuity correction||
1676256|NCT01297062|3084003|Superiority or Other||Slope|0.0008||||0.5962|2-Sided|90.0|-0.0017|0.0033|||Mixed Models Analysis||The linear mixed-effects model includes placebo-adjusted change from baseline in QTcP as response, plasma exenatide concentration as covariate, fixed intercept of zero, subject random slope.|The analysis is to test the significance of the linear regression slope (null hypothesis: slope equal to zero) between placebo-adjusted change from baseline in QTcP and exenatide concentration.|
1676257|NCT01297062|3084006|Superiority or Other||Least Squares Mean Difference|10.92|||||2-Sided|90.0|8.71|13.13|||||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.|
1676258|NCT01297062|3084007|Superiority or Other||Least Squares Mean Difference|10.56|||||2-Sided|90.0|8.46|12.67|||||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.|
1676259|NCT01297062|3084008|Superiority or Other||Least Squares Mean Difference|5.47|||||2-Sided|90.0|2.82|8.12|||||The MMRM includes Treatment (Moxifloxacin versus Placebo), Time, Period, Sequence, and Time-Treatment interaction as fixed effects, subject random intercept. Multiplicity adjusted CI for the mean difference is shown.|Assay sensitivity of moxifloxacin is established if the lower limit of the 2-sided 90% CI for difference in change from baseline in QTcP (moxifloxacin - placebo) is greater than 5 msec.|
1676260|NCT01297062|3084009|Non-Inferiority or Equivalence|Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-1.13|||||2-Sided|90.0|-2.11|-0.15|||||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.|
1676261|NCT01297062|3084010|Non-Inferiority or Equivalence|Non-inferiority is established if the upper limit of 2-sided 90% CI, equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-2.02|||||2-Sided|90.0|-2.88|-1.16|||||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.|
1676262|NCT01297062|3084011|Non-Inferiority or Equivalence|Non-inferiority is established if the upper limit of 2-sided 90% confidence interval (CI), equivalent to the upper limit of 1-sided 95% CI, for change from baseline in QTcP (exenatide - placebo) is below 10 msec.|Least Squares Mean Difference|-1.36|||||2-Sided|90.0|-2.21|-0.5|||||The MMRM includes Treatment (Exenatide versus Placebo), Day, Time, Period, Sequence, and Day-Time-Treatment interaction as fixed effects, subject random intercept.|60 evaluable subjects gives more than 90% power to show non-inferiority of exenatide versus placebo, using t-test in 2-way crossover, alpha=0.05, true difference of 5 msec, and standard deviation of the within-subject difference of 10.04 msec.|
1676263|NCT01296841|3084014|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|We performed t-test statistics for univariate comparisons for continuous variables.|||
1676264|NCT01296412|3084058|Superiority or Other||Difference in percent|-4.5|||||2-Sided|95.0|-12.7|3.7|||||||
1676265|NCT01296412|3084059|Superiority or Other||Difference in percent|-9.5|||||2-Sided|95.0|-17.4|-1.5|||||||
1676266|NCT01296412|3084060|Superiority or Other||Difference in least squares mean|5.9|||||2-Sided|95.0|0.5|11.4|||||||
1676267|NCT01296412|3084061|Non-Inferiority or Equivalence|The sitagliptin-based treatment paradigm was to be declared non-inferior to the liraglutide-based treatment paradigm in lowering A1C at Week 26 if the upper bound of 95% confidence intervals of between group difference was less than the non-inferiority margin of 0.4%.|Difference in least squares mean|0.09|||||2-Sided|95.0|-0.05|0.23|||||||
1676268|NCT01296347|3084071|Superiority|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1676269|NCT01296347|3084072|Superiority|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1676270|NCT01296347|3084073|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1676271|NCT01296347|3084074|Superiority|||||||0.47|||||||Wilcoxon (Mann-Whitney)||||
1676272|NCT01296347|3084076|Superiority|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||6 months|
1676273|NCT01296347|3084076|Superiority|||||||1|||||||Wilcoxon (Mann-Whitney)|||3 month|
1676274|NCT01296347|3084076|Superiority|||||||0.71|||||||Wilcoxon (Mann-Whitney)|||6 weeks|
1676275|NCT01296347|3084077|Superiority|||||||0.33|||||||Wilcoxon (Mann-Whitney)||||
1676276|NCT01295814|3084155|Superiority or Other|||||||0.67||||||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided|||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|
1676277|NCT01295814|3084156|Superiority or Other||Mean Difference (Final Values)|6.3||||0.76|2-Sided|95.0|2.6|10.0||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in PUF in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|
1676278|NCT01295814|3084157|Superiority or Other||Mean Difference (Final Values)|3.9||||0.76|2-Sided|95.0|2.1|5.8||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in ICPI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|
1676279|NCT01295814|3084158|Superiority or Other||Mean Difference (Final Values)|4.0||||0.99|2-Sided|95.0|1.7|6.3||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in ICSI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|
1676314|NCT01294644|3084302|Superiority or Other||LS Mean Difference|1.26|||<|0.001|2-Sided|95.0|0.87|1.65|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.|||
1676280|NCT01295814|3084159|Non-Inferiority or Equivalence|"The study had acceptable sensitivity with a statistical power of 0.99 (99%) for the improvement in the adalimumab group from baseline to week 12.~The study had acceptable sensitivity with a statistical power of 0.92 (92%) for the improvement in the placebo group from baseline to week 12."|Mean Difference (Final Values)|7.9||||0.75|2-Sided|95.0|4.0|11.8||Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|t-test, 2 sided||Confidence interval was improvement in OSPI in the adalimumab group from baseline to week 12.|Statistical improvement in the adalimumab group compared to the placebo group from baseline to week 12.|
1676281|NCT01295281|3084228|Non-Inferiority or Equivalence|Two catheters were tested regarding subjects' perception when using them, in a cross over design. After using each catheter for 1 week the subjects were asked: “Do you experience discomfort when using your catheter”?, and the subjects were supposed to answer “Yes” or “No”. The hypothesis to be investigated was that the tolerability/perception was about the same for each type of catheter, i.e. the POBE 2.0 should be non-inferior compared to PVC. H0: p(disc. POBE - Yes) = p(disc. PVC - Yes)||||||0.0066|||||||McNemar|||The size of the target population was estimated by calculating 95% Confidence Interval (CI) of a possible difference between the two catheter types. The width of the interval was decided on the proportion of patients who would prefer one or the other catheter. Max width was seen when both proportions were 0.5. A total of 90 evaluable subjects limited the maximum width to 0.41, which was considered narrow enough from a scientific point of view, why this sample size was used in the study.|
1676282|NCT01295216|3084234|Superiority or Other||Mean Difference (Net)|0.01|||||2-Sided|95.0|-1.29|1.32|||||Diastolic blood pressure for 12 months||
1676283|NCT01295216|3084234|Superiority or Other||Mean Difference (Net)|-0.37|||||2-Sided|95.0|-2.15|1.4|||||Systolic blood pressure at 12 months||
1676284|NCT01295112|3084235|Non-Inferiority|Non-inferiority will be described by the 95% upper bound of the confidence interval on the difference in the improvement from baseline in BCVA|Mean Difference (Final Values)|2.51|Standard Deviation|17.96||0.53|2-Sided|90.0|-4.43|9.74||The p-value is assume superiority. The 95% upper confidence (upper end of the 90% Confidence interval) interval for the non-inferiority analysis is provided below.|t-test, 1 sided||||
1676285|NCT01295112|3084236|Superiority|||||||2e-05|||||||Cochran-Mantel-Haenszel||||
1676286|NCT01294800|3084244|Superiority or Other||Difference in Least Squares Mean|0.5||||0.2021|2-Sided|95.0|-0.25|1.19|||Constrained longitudinal data analysis||||
1676287|NCT01294800|3084244|Superiority or Other||Difference in Least Squares Mean|0.5||||0.1847|2-Sided|95.0|-0.23|1.19|||Constrained longitudinal data analysis||||
1676288|NCT01294800|3084244|Superiority or Other||Difference in Least Squares Mean|0.7||||0.0509|2-Sided|95.0|0.0|1.43|||Constrained longitudinal data analysis||||
1676289|NCT01294800|3084245|Superiority or Other||Difference in proportions of responders|-4.9||||0.508|2-Sided|95.0|-17.78|7.97|||A generalized linear mixed model||||
1676290|NCT01294800|3084245|Superiority or Other||Difference in proportions of responders|5.7||||0.39|2-Sided|95.0|-7.73|18.81|||A generalized linear mixed model||||
1676291|NCT01294800|3084245|Superiority or Other||Difference in proportions of responders|5.7||||0.404|2-Sided|95.0|-7.75|19.0|||A generalized linear mixed model||||
1676292|NCT01294800|3084246|Superiority or Other||Difference in Least Squares Mean|-0.3||||0.3386|2-Sided|95.0|-1.04|0.36|||Constrained longitudinal data analysis||||
1676293|NCT01294800|3084246|Superiority or Other||Difference in Least Squares Mean|-0.5||||0.1844|2-Sided|95.0|-1.16|0.22|||Constrained longitudinal data analysis||||
1676294|NCT01294800|3084246|Superiority or Other||Difference in Least Squares Mean|-0.7||||0.0564|2-Sided|95.0|-1.37|0.02|||Constrained longitudinal data analysis||||
1676295|NCT01294709|3084271|Superiority or Other||Difference in Least Squares Means|-7.14|||||2-Sided|90.0|-22.03|7.74||||||Telcagepant minus Placebo Treatment Difference|
1676296|NCT01294709|3084272|Superiority or Other||Difference in Least squares meand|-0.056|||||2-Sided|90.0|-0.19|0.076||||||Telcagepant minus Placebo Treatment Difference|
1676297|NCT01294709|3084273|Superiority or Other||Difference in Least Squares Means|-6.9|||||2-Sided|90.0|-17.66|3.86||||||Telcagepant minus Placebo Treatment Difference|
1676298|NCT01294683|3084284|Superiority or Other||Difference in Percentages|-0.533|||||2-Sided|95.0|-3.916|2.619|||||Miettinen and Nurminen Method|Period III|
1676299|NCT01294683|3084284|Superiority or Other||Difference in Percentages|-0.412|||||2-Sided|95.0|-4.28|3.45||||||Periods I/II|
1676300|NCT01294683|3084285|Superiority or Other||Difference in Percentages|0.889|||||2-Sided|95.0|-7.599|9.338|||||Miettinen and Nurminen Method|Period III|
1676301|NCT01294683|3084285|Superiority or Other||Difference in Percentages|-1.029|||||2-Sided|95.0|-7.301|5.252|||||Miettinen and Nurminen Method|Periods I/II|
1676302|NCT01294683|3084286|Superiority or Other||Difference in Percentages|0.0|||>|0.999|2-Sided|95.0|-0.967|0.967|||Miettinen and Nurminen|||Periods I/II|
1676303|NCT01294683|3084287|Superiority or Other||Difference in Percentages|0.395||||0.69|2-Sided|95.0|-2.091|2.966|||Miettinen and Nurminen|||Period III|
1676304|NCT01294683|3084287|Superiority or Other||Difference in Percentages|0.617||||0.255|2-Sided|95.0|-0.575|2.023|||Miettinen and Nurminen|||Periods I/II|
1676305|NCT01294683|3084290|Superiority or Other||Difference in Percentages|0.87||||0.166|2-Sided|95.0|-0.858|3.118|||Miettinen and Nurminen|||Period III|
1676306|NCT01294683|3084292|Superiority or Other||Difference in Percentages|0.87||||0.166|2-Sided|95.0|-0.858|3.118|||Miettinen and Nurminen|||Period III|
1676307|NCT01294683|3084292|Superiority or Other||Difference in Percentages|-0.206||||0.563|2-Sided|95.0|-1.303|0.779|||Miettinen and Nurminen|||Periods I/II|
1676308|NCT01294683|3084293|Superiority or Other||Difference in Percentages|1.304||||0.09|2-Sided|95.0|-0.427|3.768|||Miettinen and Nurminen|||Period III|
1676309|NCT01294683|3084293|Superiority or Other||Difference in Percentages|-0.206||||0.654|2-Sided|95.0|-1.434|0.936|||Miettinen and Nurminen|||Periods I/II|
1676310|NCT01294644|3084300|Superiority or Other|||||||0.001|||||||Pearson's chi-square test||||
1676311|NCT01294644|3084300|Superiority or Other|||||||0.009|||||||Pearson's chi-square test||||
1676315|NCT01294644|3084302|Superiority or Other||LS Mean Difference|1.36|||<|0.001|2-Sided|95.0|0.97|1.75|||ANCOVA|The model includes the fixed effect factor treatment and the Baseline values as covariate.|||
1676316|NCT01294644|3084303|Superiority or Other||LS Mean Difference|-0.4|||<|0.001|2-Sided|95.0|-0.56|-0.24|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit*treatment interaction, and the baseline CR-SMFRS values as covariate.|||
1676317|NCT01294644|3084303|Superiority or Other||LS Mean Difference|-0.35|||<|0.001|2-Sided|95.0|-0.51|-0.19|||Mixed Models Repeated Measures|The model included the fixed effect factors visit and treatment, the visit*treatment interaction, and the Baseline CR-SMFRS values as covariate.|||
1676318|NCT01294644|3084304|Superiority or Other||Odds Ratio (OR)|4.62|||<|0.001|2-Sided|95.0|2.65|8.04|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios >1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."|
1676319|NCT01294644|3084304|Superiority or Other||Odds Ratio (OR)|5.37|||<|0.001|2-Sided|95.0|3.06|9.44|||Regression, Logistic|Logistic regression analysis with treatment and Baseline SSRS value in the model.|Odds ratio was based on a logistic regression model adjusted for Baseline score. Odds ratios >1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."|
1676320|NCT01294644|3084305|Superiority or Other||Odds Ratio (OR)|11.53||||0.021|2-Sided|95.0|1.46|91.24|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios >1 indicate a positive treatment effect.||
1676321|NCT01294644|3084305|Superiority or Other||Odds Ratio (OR)|11.71||||0.02|2-Sided|95.0|1.48|92.67|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|Odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios >1 indicate a positive treatment effect.||
1676322|NCT01294644|3084306|Superiority or Other||Odds Ratio (OR)|3.13|||<|0.001|2-Sided|95.0|1.83|5.36|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios >1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 2 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."|
1676323|NCT01294644|3084306|Superiority or Other||Odds Ratio (OR)|2.6|||<|0.001|2-Sided|95.0|1.52|4.43|||Regression, Logistic|Logistic regression analysis with treatment and Baseline CR-SMFRS value in the model.|The odds ratio was based on a logistic regression model adjusted for the Baseline score. Odds ratios >1 indicate a positive treatment effect.|"The null hypothesis was there was no difference between deoxycholic acid 1 mg/cm² and placebo.~An adjustment for multiplicity was performed for the two co-primary endpoints. This was accounted for by using the larger of the two P-values in the Bonferroni-Holm scheme."|
1676324|NCT01294592|3084317|Superiority or Other||Adjusted Mean Difference|-1.8|Standard Error of the Mean|0.34|<|0.001|2-Sided|95.0|-2.5|-1.2||Month 24|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.||
1676325|NCT01294592|3084317|Superiority or Other||Adjusted Mean Difference|-1.9|Standard Error of the Mean|0.34|<|0.001|2-Sided|95.0|-2.5|-1.2||Month 21|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.||
1676326|NCT01294592|3084317|Superiority or Other||Adjusted Mean Difference|-1.7|Standard Error of the Mean|0.35|<|0.001|2-Sided|95.0|-2.4|-1.0||Month 18|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.||
1676327|NCT01294592|3084317|Superiority or Other||Adjusted Mean Difference|-1.6|Standard Error of the Mean|0.34|<|0.001|2-Sided|95.0|-2.3|-1.0||Month 15|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.||
1676328|NCT01294592|3084317|Superiority or Other||Adjusted Mean Difference|-1.6|Standard Error of the Mean|0.32|<|0.001|2-Sided|95.0|-2.2|-1.0||Month 12|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.||
1676329|NCT01294592|3084317|Superiority or Other||Adjusted Mean Difference|-1.6|Standard Error of the Mean|0.31|<|0.001|2-Sided|95.0|-2.2|-1.0||Month 9|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.||
1676330|NCT01294592|3084317|Superiority or Other||Adjusted Mean Difference|-1.5|Standard Error of the Mean|0.31|<|0.001|2-Sided|95.0|-2.1|-0.9||Month 6|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.||
1676331|NCT01294592|3084317|Superiority or Other||Adjusted Mean Difference|-2.1|Standard Error of the Mean|0.31|<|0.001|2-Sided|95.0|-2.7|-1.5||Month 3|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.||
1676332|NCT01294592|3084317|Superiority or Other||Adjusted Mean Difference|-2.2|Standard Error of the Mean|0.28|<|0.001|2-Sided|95.0|-2.8|-1.7||Month 1|t-test, 2 sided|Values are based on t-tests from the general linear model|Estimates are based on the adjusted means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The adjusted mean difference is based on dutasteride plus tamsulosin minus Watchful Waiting All.||
1676333|NCT01294553|3084327|Superiority or Other||Percentage of participants|15.4|||||2-Sided|95.0|12.8|18.1|||||The estimated value represents the percentage of participants with an adverse event.||
1676334|NCT01294462|3084331|Superiority or Other||Hazard Ratio (HR)|1.51|||||2-Sided|95.0|0.91|2.5|||||Ticagrelor/Placebo|No formal statistical comparison based on hypothesis test.|
1676335|NCT01294462|3084332|Superiority or Other||Hazard Ratio (HR)|1.72|||||2-Sided|95.0|1.23|2.4|||||Ticagrelor/Placebo|No formal statistical comparison.|
1676336|NCT01294462|3084333|Superiority or Other||Hazard Ratio (HR)|1.47|||||2-Sided|95.0|0.88|2.44|||||Ticagrelor/Placebo|No formal statistical comparison based on hypothesis test.|
1676337|NCT01294462|3084334|Superiority or Other||Hazard Ratio (HR)|1.54|||||2-Sided|95.0|0.94|2.53|||||Ticagrelor/Placebo|No formal statistical comparison.|
1676338|NCT01294449|3084335|Superiority or Other||Hazard Ratio (HR)|0.68||||0.028|2-Sided|95.0|0.484|0.96|||Regression, Cox||The hazard ratio was calculated as the hazard rate of mortality in the CRT-D arm over the hazard rate of mortality in the ICD arm. A hazard ratio lower than 1 represents a reduction in relative risk of mortality for CRT-D compared to ICD.|These data represent the indicated sub population of left bundle branch block subjects only. (Left bundle branch block N= 110 ICD group: 181 CRT-D group)|
1676339|NCT01294449|3084335|Superiority or Other||Hazard Ratio (HR)|0.88||||0.37|2-Sided|95.0|0.67|1.161|||Regression, Cox||The hazard ratio was calculated as the hazard rate of mortality in the CRT-D group over the hazard rate of mortality in the ICD group. A hazard ratio lower than 1 represents a reduction in relative risk of mortality for CRT-D compared to ICD.|The sample size for the analysis included subjects from the original MADIT-CRT IDE (NCT00180271) that did not participate in the Registry portion, these subjects are censored at the time of study conclusion, withdrawal or death during the IDE. This was done as the Registry is a post approval continuation of the follow-up from the MADIT-CRT IDE trial. This is not a pooled analysis from separate studies.|
1676340|NCT01294423|3084350|Superiority or Other||Mean Difference (Final Values)|-1.38|Standard Error of the Mean|0.354||0.0001|2-Sided|95.0|-2.08|-0.69||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1676341|NCT01294423|3084350|Superiority or Other||Mean Difference (Final Values)|-1.29|Standard Error of the Mean|0.3533||0.0003|2-Sided|95.0|-1.98|-0.59||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1676342|NCT01294423|3084351|Superiority or Other||Mean Difference (Final Values)|-19.5|Standard Error of the Mean|2.892|<|0.0001|2-Sided|95.0|-25.2|-13.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1676343|NCT01294423|3084351|Superiority or Other||Mean Difference (Final Values)|-14.4|Standard Error of the Mean|2.902|<|0.0001|2-Sided|95.0|-20.1|-8.7||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c at randomization by gender) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1676344|NCT01294423|3084352|Superiority or Other||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.0851|<|0.0001|2-Sided|95.0|-0.56|-0.23||significant at alpha=0.027 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and gender as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)|
1676345|NCT01294423|3084352|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.0853|<|0.0001|2-Sided|95.0|-0.52|-0.18||significant at alpha=0.027 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and gender as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)|
1676346|NCT01294397|3084356|Superiority or Other||Least Squares Mean Ratio of Day 22/Day 1|0.92|||||2-Sided|90.0|0.81|1.05|||||Two one-sided tests|Log-transformed Cmax was analyzed with a mixed-effects model with treatment as the fixed effect and subject as the random effect. The mean difference between day 22 and day 1 was expressed as a percentage of the reference (day 1). The mean differences and the 90% CIs were back transformed to produce the ratio (day 22 vs. day 1) of the geometric means and the 90% CIs. If the CI for the ratio was within the standard acceptance range of 0.80 to 1.25, absence of an interaction was concluded.|
1676347|NCT01294397|3084357|Superiority or Other||Least Squares Mean Ratio of Day 22/Day 1|0.96|||||2-Sided|90.0|0.85|1.08|||||Two one-sided tests|Log-transformed AUC0-168 was analyzed with a mixed-effects model with treatment as the fixed effect and subject as the random effect. The mean difference between day 22 and day 1 was expressed as a percentage of the reference (day 1). The mean differences and the 90% CIs were back transformed to produce the ratio (day 22 vs. day 1) of the geometric means and the 90% CIs. If the CI for the ratio was within the standard acceptance range of 0.80 to 1.25, absence of an interaction was concluded.|
1676350|NCT01294241|3084390|Superiority or Other|||||||0.33||||||Post-hoc superiority analysis|Wilcoxon (Mann-Whitney)|||The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.|
1676351|NCT01294241|3084391|Superiority or Other||||||=|0||||||Post-hoc superiority analysis|Wilcoxon (Mann-Whitney)|||The intra-individual difference in median percentage of wound epithelialization was tested using a two-sided Wilcoxon test.|
1676352|NCT01294241|3084392|Superiority or Other||||||=|0||||||Post-hoc superiority analysis: Wounds that were either evaluated controversially (n=2) or as being equal (n=2) were excluded from the analysis of the primary efficacy variable.|Two-sided exact binomial test|||The intra-individual difference in reepithelialization of wound (halves) was tested using a two-sided exact binomial test. The test was performed at a significance level of 5% for the null-hypothesis of no difference δ = 0 against the hypotheses δ ≠ 0: H0: δ = 0 H1: δ ≠ 0|
1676353|NCT01294163|3084394|Non-Inferiority or Equivalence|It was to be concluded that xenon was non-inferior to sevoflurane if the upper bound of the 2-sided 95% CI for the difference [mean troponin I level (xenon) – mean troponin I level (sevoflurane)] was below the margin of 0.15 ng/mL.|Mean Difference (Final Values)|-0.09||||0.0186|2-Sided|95.0|-0.3|0.11|||ANCOVA|||As the residuals from the primary ANCOVA model were non-normal and skewed, the non-inferiority analysis was repeated using log-transformed blood troponin levels.|
1676354|NCT01294163|3084403|Non-Inferiority or Equivalence|Xenon was to be concluded non-inferior to sevoflurane if the upper bound of the 2-sided 95% CI for the difference [mean troponin I level (xenon) - mean troponin I level (sevoflurane)] was below the prespecified margin of 0.63 ng/mL. Assuming a margin of 0.63, a same concentration of troponin I at 24 hours in the xenon and sevoflurane groups, a common standard deviation of 1.9 ng/mL and a one-sided type I error of 0.025, 164 patients per group were deemed necessary to demonstrate non-inferiority.|Mean Difference (Final Values)|-0.4||||0.02|2-Sided|95.0|-1.27|0.47|||ANCOVA|Treatment difference and 95%CI assessed using ANCOVA with 24h troponin I as response, treatment group and pre-induction troponin I as covariates.|||
1676355|NCT01294150|3084406|Superiority or Other|||||||0.003||||||Assuming unequal variances comparing mean improvement in the UL group to 125% of the mean improvement in the Control group. A p-value of 0.025 or less associated with UL is considered evidence of statistical significance|t-test, 2 sided||||
1676356|NCT01293084|3084457|Superiority or Other||Median Difference (Final Values)|2.3||||0.32|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1676357|NCT01293084|3084458|Superiority or Other||Median Difference (Final Values)|2.2||||0.62|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1676358|NCT01293006|3084460|Superiority or Other||Mean Difference (Final Values)|-0.1|||||2-Sided|90.0|-0.5|0.31||||||Difference (Suvorexant - Placebo) of Least Squares Means|
1676359|NCT01293006|3084461|Superiority or Other||Mean Difference (Final Values)|0.45|||||2-Sided|90.0|0.1|0.8||||||Day 4, Wake, Difference (Suvorexant - Placebo) of Least Squares Means|
1676360|NCT01293006|3084461|Superiority or Other||Mean Difference (Final Values)|0.26|||||2-Sided|90.0|-0.26|0.78||||||Day 4, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means|
1676361|NCT01293006|3084461|Superiority or Other||Mean Difference (Final Values)|0.33|||||2-Sided|90.0|-0.32|0.98||||||Day 4, REM, Difference (Suvorexant - Placebo) of Least Squares Means|
1676362|NCT01293006|3084461|Superiority or Other||Mean Difference (Final Values)|-0.21|||||2-Sided|90.0|-0.61|0.18||||||Day 1, Wake, Difference (Suvorexant - Placebo) of Least Squares Means|
1676363|NCT01293006|3084461|Superiority or Other||Mean Difference (Final Values)|-0.13|||||2-Sided|90.0|-0.53|0.27||||||Day 1, Non-REM, Difference (Suvorexant - Placebo) of Least Squares Means|
1676364|NCT01293006|3084461|Superiority or Other||Mean Difference (Final Values)|0.03|||||2-Sided|90.0|-0.41|0.47||||||Day 1, REM, Difference (Suvorexant - Placebo) of Least Squares Means|
1676365|NCT01293006|3084462|Superiority or Other||Mean Difference (Final Values)|2.05|||||2-Sided|90.0|0.33|3.77||||||Day 4, Difference (Suvorexant - Placebo) of Least Squares Means|
1676366|NCT01293006|3084462|Superiority or Other||Mean Difference (Final Values)|0.72|||||2-Sided|90.0|-0.6|2.04||||||Day 1, Difference (Suvorexant - Placebo) of Least Squares Means|
1676367|NCT01293006|3084463|Superiority or Other||Mean Difference (Final Values)|0.32|||||2-Sided|90.0|0.0|0.63||||||Day 4, SaO2 <85%, Difference (Suvorexant - Placebo) of Least Squares Means|
1676368|NCT01293006|3084463|Superiority or Other||Mean Difference (Final Values)|0.82|||||2-Sided|90.0|-5.77|7.41||||||Day 4, SaO2 <90%, Difference (Suvorexant - Placebo) of Least Squares Means|
1676369|NCT01293006|3084463|Superiority or Other||Mean Difference (Final Values)|0.21|||||2-Sided|90.0|-0.08|0.5||||||Day 1, SaO2 <85%, Difference (Suvorexant - Placebo) of Least Squares Means|
1676370|NCT01293006|3084463|Superiority or Other||Mean Difference (Final Values)|1.03|||||2-Sided|90.0|-1.3|3.36||||||Day 1, SaO2 <90%, Difference (Suvorexant - Placebo) of Least Squares Means|
1676371|NCT01293006|3084466|Superiority or Other||Mean Difference (Final Values)|0.39|||||2-Sided|90.0|-0.12|0.91||||||Difference (Suvorexant - Placebo) of Least Squares Means|
1676372|NCT01292746|3084491|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|2 sided t-test for correlated samples.|||
1676373|NCT01292603|3084506|Superiority or Other||Adjusted geometric mean ratio|1.01|||||2-Sided|90.0|0.895|1.139|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.||
1676374|NCT01292603|3084507|Superiority or Other||Adjusted geometric mean ratio|14.884|||||2-Sided|90.0|11.215|19.755|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.||
1676375|NCT01292603|3084508|Superiority or Other||Adjusted geometric mean ratio|0.719|||||2-Sided|90.0|0.653|0.792|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.||
1676376|NCT01292603|3084509|Superiority or Other||Adjusted geometric mean ratio|1.102|||||2-Sided|90.0|0.979|1.242|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.||
1676377|NCT01292603|3084510|Non-Inferiority or Equivalence|A standard non-inferiority margin of 0.8 for the ratio of Ctrough was used. The non-inferiority limit corresponds to a maximal 20 percent (%) loss in Ctrough which is considered acceptable given the high variability and range of Ctrough data, with an 80% power and a one-sided alpha of 0.05.|Adjusted geometric mean ratio|1.533|||||2-Sided|90.0|1.269|1.852|||||Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.||
1676424|NCT01292226|3084554|Superiority or Other|||||||0.0907||||||IMPDH activity, time 0 [trough]|ANOVA||||
1676378|NCT01292486|3084519|Non-Inferiority or Equivalence|The non-inferiority margin was 2 days.|Median Difference (Final Values)|0.0|||<|0.025|2-Sided|95.0|0.0|0.0|||Hodges-Lehman estimation|||The null hypothesis was that the median day to neutrophil recovery in this study was more than two days longer than historical controls.|
1676379|NCT01292473|3084520|Superiority or Other||||||<|0.0001||||||Refer to the Type-I error control plan.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg.|
1676380|NCT01292473|3084520|Superiority or Other||||||<|0.0905||||||Refer to the Type-I error control plan.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.|
1676381|NCT01292473|3084520|Superiority or Other||||||<|0.1361||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.|
1676382|NCT01292473|3084521|Superiority or Other||Least Squares Mean Difference|-3.79||||0.0004|2-Sided|95.0|-5.85|-1.73||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.|
1676383|NCT01292473|3084521|Superiority or Other||Least Squares Mean Difference|-2.51||||0.0215|2-Sided|95.0|-4.64|-0.38||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.|
1676384|NCT01292473|3084521|Superiority or Other||Least Squares Mean Difference|-1.68||||0.1207|2-Sided|95.0|-3.82|0.45||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.|
1676385|NCT01292473|3084522|Superiority or Other||Least Squares Mean Difference|-7.15|||<|0.0001|2-Sided|95.0|-9.03|-5.27||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and the omalizumab 300 mg groups.|
1676386|NCT01292473|3084522|Superiority or Other||Least Squares Mean Difference|-3.76|||<|0.0001|2-Sided|95.0|-5.61|-1.9||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.|
1676387|NCT01292473|3084522|Superiority or Other||Least Squares Mean Difference|-2.48|||<|0.0082|2-Sided|95.0|-4.32|-0.65||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.|
1676388|NCT01292473|3084523|Superiority or Other||||||<|0.0001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.|
1676389|NCT01292473|3084523|Superiority or Other||||||<|0.0045||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.|
1676390|NCT01292473|3084523|Superiority or Other||||||<|0.4366||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.|
1676391|NCT01292473|3084524|Superiority or Other||||||<|0.0001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between placebo and omalizumab 300 mg groups.|
1676392|NCT01292473|3084524|Superiority or Other||||||<|0.001||||||Refer to the Type-I error control plan.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.|
1676393|NCT01292473|3084524|Superiority or Other||||||<|0.3419||||||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.|
1676394|NCT01292473|3084525|Superiority or Other||Hazard Ratio (HR)|2.12|||<|0.0001|2-Sided|95.0|1.48|3.03||Refer to the Type-I error control plan.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between placebo and omalizumab 300 mg groups.|
1676425|NCT01292226|3084554|Superiority or Other|||||||0.904||||||IMPDH II, time 120 [2 hours after administration at Week 12]|ANOVA||||
1676395|NCT01292473|3084525|Superiority or Other||Hazard Ratio (HR)|1.59|||<|0.0101|2-Sided|95.0|1.12|2.26||Refer to the Type-I error control plan.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.|
1676396|NCT01292473|3084525|Superiority or Other||Hazard Ratio (HR)|1.43|||<|0.0478|2-Sided|95.0|1.0|2.05||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between Placebo and Omalizumab 75 mg.|
1676397|NCT01292473|3084526|Superiority or Other||Least Squares Mean Difference|-7.09|||<|0.0001|2-Sided|95.0|-9.26|-4.93||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.|
1676398|NCT01292473|3084526|Superiority or Other||Least Squares Mean Difference|-4.51|||<|0.0001|2-Sided|95.0|-6.65|-2.36||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.|
1676399|NCT01292473|3084526|Superiority or Other||Least Squares Mean Difference|-2.01|||<|0.0603|2-Sided|95.0|-4.11|0.09||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.|
1676400|NCT01292473|3084527|Superiority or Other||Least Squares Mean Difference|-12.4|||<|0.0001|2-Sided|95.0|-16.13|-8.66||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.|
1676401|NCT01292473|3084527|Superiority or Other||Least Squares Mean Difference|-7.69|||<|0.0001||95.0|-11.49|-3.88||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.|
1676402|NCT01292473|3084527|Superiority or Other||Least Squares Mean Difference|-2.73|||<|0.1575|2-Sided|95.0|-6.53|1.07||Refer to the Type-I error control plan. The p-value was not evaluated for statistical significance in accordance with the Type I error control plan provided in the Detailed Description.|ANCOVA|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.|
1676403|NCT01292473|3084528|Superiority or Other||Least Squares Mean Difference|-4.81|||<|0.0001|2-Sided|95.0|-6.49|-3.13||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups.|
1676404|NCT01292473|3084528|Superiority or Other||Least Squares Mean Difference|-3.04|||<|0.0011|2-Sided|95.0|-4.85|-1.24||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups.|
1676405|NCT01292473|3084528|Superiority or Other||Least Squares Mean Difference|-0.69|||<|0.4637|2-Sided|95.0|-2.54|1.16||Refer to the Type-I error control plan.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis is that there is no difference between the placebo and omalizumab 75 mg groups.|
1676406|NCT01292239|3084546|Superiority or Other||(see comment)|32.6|||<|0.0001|2-Sided|95.0|19.75|45.4||The p-value was based on the asymptomatic distribution of the generalized Cochran-Mantel-Haenszel (CMH) statistic controlling for stratification factors.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for stratification factors (age and IL28B genotype).|The parameter estimated was the difference of stratum adjusted proportion between groups.||
1676407|NCT01292239|3084547|Superiority or Other||(see comment)|27.5|||<|0.0001|2-Sided|95.0|14.38|40.56||The p-value was based on the asymptomatic distribution of the generalized Cochran-Mantel-Haenszel (CMH) statistic controlling for stratification factors.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for stratification factors (age and IL28B genotype).|The parameter estimated was the difference of stratum adjusted proportion between groups.||
1676408|NCT01292226|3084548|Superiority or Other|||||||0.0515||||||AUC MPA|ANOVA||||
1676409|NCT01292226|3084548|Superiority or Other|||||||0.0131||||||Total MPA|ANOVA||||
1676410|NCT01292226|3084548|Superiority or Other|||||||0.0656||||||Free MPA|ANOVA||||
1676411|NCT01292226|3084549|Superiority or Other|||||||0.6398||||||AUC MPA|ANOVA||||
1676412|NCT01292226|3084549|Superiority or Other|||||||0.5177||||||Total MPA|ANOVA||||
1676413|NCT01292226|3084549|Superiority or Other|||||||0.9432||||||Free MPA|ANOVA||||
1676414|NCT01292226|3084550|Superiority or Other|||||||0.7087||||||AUC MPA|ANOVA||||
1676415|NCT01292226|3084550|Superiority or Other|||||||0.2681||||||Total MPA|ANOVA||||
1676416|NCT01292226|3084550|Superiority or Other|||||||0.7332||||||Free MPA|ANOVA||||
1676417|NCT01292226|3084551|Superiority or Other|||||||0.576||||||IMPDH II|ANOVA||||
1676418|NCT01292226|3084551|Superiority or Other|||||||0.1328||||||IMPDH I|ANOVA||||
1676419|NCT01292226|3084552|Superiority or Other|||||||0.944||||||IMPDH II|ANOVA||||
1676420|NCT01292226|3084552|Superiority or Other|||||||0.0316||||||IMPDH I|ANOVA||||
1676421|NCT01292226|3084553|Superiority or Other|||||||0.3823||||||IMPDH II|ANOVA||||
1676422|NCT01292226|3084553|Superiority or Other|||||||0.413||||||IMPDH I|ANOVA||||
1676429|NCT01292226|3084555|Superiority or Other|||||||0.8504||||||Time 120 [2 hours after administration at Week 12]|ANOVA||||
1676430|NCT01292226|3084555|Superiority or Other|||||||0.7455||||||time 0 [trough]|ANOVA||||
1676431|NCT01292226|3084556|Superiority or Other|||||||0.2987||||||Total MPA, time 120 [2 hours after administration at Week 12]|ANOVA||||
1676432|NCT01292226|3084556|Superiority or Other|||||||0.3658||||||Free MPA, time 120 [2 hours after administration at Week 12]|ANOVA||||
1676433|NCT01292226|3084556|Superiority or Other|||||||0.9904||||||Total MPA, time 0 [trough]|ANOVA||||
1676434|NCT01292226|3084556|Superiority or Other|||||||0.9372||||||Free MPA, time 0 [trough]|ANOVA||||
1676435|NCT01292226|3084557|Superiority or Other|||||||0.3428||||||Time 120 [2 hours after administration at Week 12]|ANOVA||||
1676436|NCT01292226|3084557|Superiority or Other|||||||0.5796||||||Time 0 [trough]|ANOVA||||
1676437|NCT01292226|3084558|Superiority or Other|||||||0.0958||||||Total MPA, time 120 [2 hours after administration at Week 12]|ANOVA||||
1676438|NCT01292226|3084558|Superiority or Other|||||||0.7772||||||Free MPA, time 120 [2 hours after administration at Week 12]|ANOVA||||
1676439|NCT01292226|3084558|Superiority or Other|||||||0.6564||||||Total MPA, time 0 [trough]|ANOVA||||
1676440|NCT01292226|3084558|Superiority or Other|||||||0.3892||||||Free MPA, time 0 [trough]|ANOVA||||
1676441|NCT01292226|3084559|Superiority or Other|||||||0.541||||||Total MPA, time 120 [2 hours after administration at Week 12]|ANOVA||||
1676442|NCT01292226|3084559|Superiority or Other|||||||0.6798||||||Total MPA, time 0 [trough]|ANOVA||||
1676443|NCT01292226|3084559|Superiority or Other|||||||0.7322||||||Free MPA, time 120 [2 hours after administration at Week 12]|ANOVA||||
1676444|NCT01292226|3084559|Superiority or Other|||||||0.4505||||||Free MPA, time 0 [trough]|ANOVA|Analysis of variance (ANOVA)|||
1676445|NCT01292187|3084576|Superiority or Other|||||||0.034|||||||Mixed Models Analysis||||
1676446|NCT01292187|3084577|Superiority or Other|||||||0.0265|||||||Mixed Models Analysis||||
1676447|NCT01292005|3084588|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||P < 0.05 was considered statistically significant.|
1676448|NCT01292005|3084589|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||P < 0.05 was considered statistically significant.|
1676449|NCT01292005|3084590|Superiority or Other|||||||0.06|||||||t-test, 2 sided|||P < 0.05 was considered statistically significant.|
1676450|NCT01292005|3084591|Superiority or Other|||||||0.03|||||||t-test, 2 sided|||Comparison was for length of hospitalization >10 days. P < 0.05 was considered statistically significant.|
1676451|NCT01292005|3084591|Superiority or Other|||||||0.04|||||||t-test, 2 sided|||Comparison between arms for length of hospitalization > 4 days. P < 0.05 was considered statistically significant.|
1676452|NCT01292005|3084592|Superiority or Other|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||p<0.05 was considered statistically significant.|
1676453|NCT01292005|3084593|Superiority or Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||p<0.05 was considered statistically significant.|
1676454|NCT01292005|3084594|Superiority or Other|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p<0.05 was considered statistically significant.|
1676455|NCT01292005|3084594|Superiority or Other|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p<0.05 was considered statistically significant.|
1676456|NCT01292005|3084595|Superiority or Other|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p<0.05 was considered statistically significant.|
1676457|NCT01292005|3084595|Superiority or Other|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p<0.05 was considered statistically significant.|
1676458|NCT01292005|3084596|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p<0.05 was considered statistically significant.|
1676459|NCT01292005|3084596|Superiority or Other|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p<0.05 was considered statistically significant.|
1676460|NCT01292005|3084597|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 3. p<0.05 was considered statistically significant.|
1676461|NCT01292005|3084597|Superiority or Other|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Change from Day 0 to Day 1. p<0.05 was considered statistically significant.|
1676462|NCT01291836|3084598|Superiority or Other||ROC AUC|0.65|||||2-Sided|95.0|0.598|0.702||||||Null Hypothesis: AUC ≤0.55, using a one-sided z-test at a significance level of 0.025. Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.
1676463|NCT01291836|3084599|Superiority or Other||Area under Receiver-Operator Curve (ROC)|0.658|||||2-Sided|95.0|0.586|0.73||||||Null Hypothesis: ROC AUC of 0.58; using a one-sided z-test at a significance level of 0.025. Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.|Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1.
1676464|NCT01291173|3084612|Superiority or Other||Mean Difference (Final Values)|0.03||||0.9814|2-Sided|95.0|-2.79|2.86|||Mixed Models Analysis|||Aggregate Mental Score|
1676465|NCT01291173|3084612|Superiority or Other||Mean Difference (Final Values)|0.64||||0.653|2-Sided|95.0|-2.17|3.45|||Mixed Models Analysis|||Aggregate Mental Score|
1676466|NCT01291173|3084612|Superiority or Other||Mean Difference (Final Values)|0.07||||0.9587|2-Sided|95.0|-2.75|2.9|||Mixed Models Analysis|||Aggregate Mental Score|
1676467|NCT01291173|3084612|Superiority or Other||Mean Difference (Final Values)|2.5||||0.0216|2-Sided|95.0|0.37|4.64|||Mixed Models Analysis|||Aggregate Physical Score|
1676468|NCT01291173|3084612|Superiority or Other||Mean Difference (Final Values)|1.09||||0.309|2-Sided|95.0|-1.02|3.21|||Mixed Models Analysis|||Aggregate Physical Score|
1676959|NCT01286012|3085379|Superiority or Other|||||||0.361|||||||Wilcoxon (Mann-Whitney)||||
1676469|NCT01291173|3084612|Superiority or Other||Mean Difference (Final Values)|1.25||||0.2504|2-Sided|95.0|-0.89|3.38|||Mixed Models Analysis|||Aggregate Physical Score|
1676470|NCT01291173|3084613|Superiority or Other||Mean Difference (Final Values)|-3.71||||0.0148|2-Sided|95.0|-6.69|-0.73|||Mixed Models Analysis||||
1676471|NCT01291173|3084613|Superiority or Other||Mean Difference (Final Values)|-2.07||||0.1725|2-Sided|95.0|-5.05|0.91|||Mixed Models Analysis||||
1676472|NCT01291173|3084613|Superiority or Other||Mean Difference (Final Values)|-2.65||||0.0824|2-Sided|95.0|-5.64|0.34|||Mixed Models Analysis||||
1676473|NCT01291173|3084614|Superiority or Other||Mean Difference (Final Values)|-8.5|||<|0.001|2-Sided|95.0|-11.99|-4.92|||Mixed Models Analysis||||
1676474|NCT01291173|3084614|Superiority or Other||Mean Difference (Final Values)|-5.4|||<|0.002|2-Sided|95.0|-8.95|-1.94|||Mixed Models Analysis||||
1676475|NCT01291173|3084614|Superiority or Other||Mean Difference (Final Values)|-3.9|||<|0.03|2-Sided|95.0|-7.44|-0.38|||Mixed Models Analysis||||
1676476|NCT01291173|3084615|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|||Hunger|
1676477|NCT01291173|3084615|Superiority or Other||||||<|0.0009|||||||Mixed Models Analysis|||Hunger|
1676478|NCT01291173|3084615|Superiority or Other||||||<|0.0149|||||||Mixed Models Analysis|||Hunger|
1676479|NCT01291173|3084615|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|||Disinhibition|
1676480|NCT01291173|3084615|Superiority or Other||||||<|0.0022|||||||Mixed Models Analysis|||Disinhibition|
1676481|NCT01291173|3084615|Superiority or Other||||||<|0.0278|||||||Mixed Models Analysis|||Disinhibition|
1676482|NCT01291173|3084615|Superiority or Other||||||<|0.0459|||||||Mixed Models Analysis|||Cognitive Restraint of Eating|
1676483|NCT01291173|3084615|Superiority or Other||||||<|0.138|||||||Mixed Models Analysis|||Cognitive Restraint of Eating|
1676484|NCT01291173|3084615|Superiority or Other||||||<|0.0371|||||||Mixed Models Analysis|||Cognitive Restraint of Eating|
1676485|NCT01291173|3084616|Superiority or Other||Mean Difference (Final Values)|0.81||||0.0505|2-Sided|95.0|0.0|1.63|||Mixed Models Analysis||||
1676486|NCT01291173|3084616|Superiority or Other||Mean Difference (Final Values)|0.4||||0.3348|2-Sided|95.0|-0.42|1.22|||Mixed Models Analysis||||
1676487|NCT01291173|3084616|Superiority or Other||Mean Difference (Final Values)|0.53||||0.2046|2-Sided|95.0|-0.29|1.35|||Mixed Models Analysis||||
1676488|NCT01291173|3084617|Superiority or Other||Mean Difference (Final Values)|0.14||||0.7697|2-Sided|95.0|-0.81|1.09|||Mixed Models Analysis||||
1676489|NCT01291173|3084617|Superiority or Other||Mean Difference (Final Values)|0.49||||0.3062|2-Sided|95.0|-0.45|1.44|||Mixed Models Analysis||||
1676490|NCT01291173|3084617|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.7538|2-Sided|95.0|-1.11|0.8|||Mixed Models Analysis||||
1676491|NCT01291173|3084618|Superiority or Other||Mean Difference (Final Values)|-4.93|||<|0.0001|2-Sided|95.0|-7.3|-2.56|||Mixed Models Analysis||||
1676492|NCT01291173|3084618|Superiority or Other||Mean Difference (Final Values)|-3.25|||<|0.0075|2-Sided|95.0|-5.62|-0.88|||Mixed Models Analysis||||
1676493|NCT01291173|3084618|Superiority or Other||Mean Difference (Final Values)|-2.97|||<|0.0142|2-Sided|95.0|-5.34|-0.6|||Mixed Models Analysis||||
1676494|NCT01291173|3084619|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1676495|NCT01291173|3084619|Superiority or Other||||||<|0.0004|||||||Chi-squared||||
1676496|NCT01291173|3084619|Superiority or Other||||||<|0.0091|||||||Chi-squared||||
1676497|NCT01291173|3084622|Superiority or Other|||||||0.0009|||||||Cochran-Mantel-Haenszel||||
1676498|NCT01291173|3084622|Superiority or Other|||||||0.0127|||||||Cochran-Mantel-Haenszel||||
1676499|NCT01291173|3084622|Superiority or Other|||||||0.0937|||||||Cochran-Mantel-Haenszel||||
1676500|NCT01291173|3084623|Superiority or Other|||||||0.0022|||||||Cochran-Mantel-Haenszel||||
1676501|NCT01291173|3084623|Superiority or Other|||||||0.0063|||||||Cochran-Mantel-Haenszel||||
1676502|NCT01291173|3084623|Superiority or Other|||||||0.3341|||||||Cochran-Mantel-Haenszel||||
1676503|NCT01291173|3084624|Superiority or Other|||||||0.0031|||||||Cochran-Mantel-Haenszel||||
1676504|NCT01291173|3084624|Superiority or Other|||||||0.0198|||||||Cochran-Mantel-Haenszel||||
1676505|NCT01291173|3084624|Superiority or Other|||||||0.4676|||||||Cochran-Mantel-Haenszel||||
1676506|NCT01291173|3084625|Superiority or Other||Mean Difference (Final Values)|-0.345||||0.0004|2-Sided|95.0|-0.534|-0.155|||Mixed Models Analysis||||
1676507|NCT01291173|3084625|Superiority or Other||Mean Difference (Final Values)|-0.258||||0.0077|2-Sided|95.0|-0.446|-0.069|||Mixed Models Analysis||||
1676508|NCT01291173|3084625|Superiority or Other||Mean Difference (Final Values)|-0.014||||0.8825|2-Sided|95.0|-0.203|0.175|||Mixed Models Analysis||||
1676509|NCT01290874|3084663|Superiority|||||||0.31|||||||Log Rank||||
1676510|NCT01290757|3084681|Non-Inferiority or Equivalence|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|124.49||||||90.0|118.11|131.21||||||Capsugel vs Qualicaps|
1676511|NCT01290757|3084682|Non-Inferiority or Equivalence|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|125.3||||||90.0|118.42|132.59||||||Capsugel vs Qualicaps|
1676512|NCT01290757|3084683|Non-Inferiority or Equivalence|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|126.22||||||90.0|119.36|133.47||||||Capsugel vs Qualicaps|
1676513|NCT01290757|3084684|Non-Inferiority or Equivalence|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|124.74||||||90.0|118.32|131.51||||||Capsugel vs Qualicaps|
1676514|NCT01290757|3084685|Non-Inferiority or Equivalence|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|125.49||||||90.0|118.69|132.67||||||Capsugel vs Qualicaps|
1676960|NCT01286012|3085380|Superiority or Other|||||||0.028|||||||Wilcoxon (Mann-Whitney)||||
1676961|NCT01286012|3085381|Superiority or Other|||||||0.6714|||||||Cochran-Mantel-Haenszel||||
1676515|NCT01290757|3084685|Non-Inferiority or Equivalence|Bioequivalence (BE). Scaled average BE is rejected, if the calculated upper 95% confidence limit of the linearized criterion is positive.|Upper 95% CI of the linearized criterion|-0.085|||||1-Sided|95.0|||||||Linearized regulatory criterion according to Tothfalusi et al (Pharmaceutical Research, 2001). The square of the difference in treatment responses divided by within-subject variance of the reference formulation minus square of ln(1.25)/0.25|Capsugel minus Qualicaps|
1676516|NCT01290757|3084686|Non-Inferiority or Equivalence|Bioequivalence (BE). Bioequivalence is accepted if 90% confidence interval lies within the common BE margins (80% and 125%).|Adjusted geometric mean ratio (%)|126.33||||||90.0|119.45|133.6||||||Capsugel vs Qualicaps|
1676517|NCT01290757|3084686|Non-Inferiority or Equivalence|Bioequivalence (BE). Scaled average BE is rejected, if the calculated upper 95% confidence limit of the linearized criterion is positive.|Upper 95% CI of the linearized criterion|-0.082|||||1-Sided|95.0|||||||Linearized regulatory criterion according to Tothfalusi et al (Pharmaceutical Research, 2001). The square of the difference in treatment responses divided by within-subject variance of the reference formulation minus square of ln(1.25)/0.25|Capsugel minus Qualicaps|
1676518|NCT01290679|3084700|Superiority or Other||Mean differences|-188.202|Standard Error of the Mean|141.1702||0.183|2-Sided|95.0|-465.507|89.104|||Piecewise linear model|||Time Missed from Work AUC72|
1676519|NCT01290679|3084700|Superiority or Other||Mean differences|-186.852|Standard Error of the Mean|121.4741||0.125|2-Sided|95.0|-425.4109|51.7059|||Piecewise linear model|||Time Missed from Work AUC60|
1676520|NCT01290679|3084701|Superiority or Other||Mean differences|-329.204|Standard Error of the Mean|123.408||0.008|2-Sided|95.0|-571.3389|-87.0695|||Piecewise Linear Model|||Impairment in Daily Activities AUC72|
1676521|NCT01290679|3084701|Superiority or Other||Mean Differences|-282.436|Standard Error of the Mean|104.9894||0.007|2-Sided|95.0|-488.415|-76.4566|||Piecewise linear model|||Impairment in Daily Activities AUC60|
1676522|NCT01290679|3084702|Superiority or Other||Mean differences|-324.363|Standard Error of the Mean|124.026||0.009|2-Sided|95.0|-567.708|-81.0182|||Piecewise Linear Model|||Impairment in Work Productivity AUC72|
1676523|NCT01290679|3084702|Superiority or Other||Mean differences|-282.16|Standard Error of the Mean|105.4927||0.008|2-Sided|95.0|-489.1252|-75.1949|||Piecewise Linear Model|||Impairment in Work Productivity AUC60|
1676524|NCT01290679|3084703|Superiority or Other||Mean differences|-18.837|Standard Error of the Mean|7.4715||0.012|2-Sided|95.0|-33.4933|-4.1801|||Piecewise Linear Model|||Fatigue Severity Score AUC72|
1676525|NCT01290679|3084703|Superiority or Other||Mean differences|-16.776|Standard Error of the Mean|6.3081||0.008|2-Sided|95.0|-29.1502|-4.4025|||Piecewise Linear Model|||Fatigue Severity Score AUC60|
1676526|NCT01290679|3084730|Superiority or Other||Difference in proportions of SVR4|32.3|||<|0.001|2-Sided|95.0|23.5|41.0|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR4 between the treatment groups.|
1676527|NCT01290679|3084731|Superiority or Other||Difference in proportions of SVR24|31.5|||<|0.001|2-Sided|95.0|22.5|40.5|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR24 between the treatment groups.|
1676528|NCT01290679|3084732|Superiority or Other||Difference in proportions of SVRW72|29.3|||<|0.001|2-Sided|95.0|20.2|38.5|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVRW72 between the treatment groups.|
1676529|NCT01290679|3084733|Superiority or Other||Difference in proportions of SVR12|32.2|||<|0.001|2-Sided|95.0|23.3|41.2|||Cochran-Mantel-Haenszel|||The null hypothesis is there is no difference in proportions of SVR12 between the treatment groups.|
1676530|NCT01290614|3084743|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1676531|NCT01290614|3084744|Superiority or Other|||||||0.57|||||||t-test, 2 sided||||
1676532|NCT01290484|3084754|Superiority or Other||Mean percentage volume change|-3.47|||||||||||||||
1676533|NCT01290445|3084756|Superiority or Other||Odds Ratio (OR)|0.65|||||2-Sided|95.0|0.37|1.16||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.|
1676534|NCT01290445|3084756|Superiority or Other||Odds Ratio (OR)|0.65|||||2-Sided|95.0|0.37|1.16||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.|
1676535|NCT01290445|3084757|Superiority or Other||Odds Ratio (OR)|0.91|||||2-Sided|95.0|0.61|1.37||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.|
1676536|NCT01290445|3084757|Superiority or Other||Odds Ratio (OR)|0.95|||||2-Sided|95.0|0.63|1.42||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.|
1676537|NCT01290445|3084758|Superiority or Other||Odds Ratio (OR)|0.7|||||2-Sided|95.0|0.51|0.97||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.|
1676538|NCT01290445|3084758|Superiority or Other||Odds Ratio (OR)|0.7|||||2-Sided|95.0|0.5|0.96||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.|
1676539|NCT01290445|3084759|Superiority or Other||Odds Ratio (OR)|0.65|||||2-Sided|95.0|0.09|4.67||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.|
1676540|NCT01290445|3084759|Superiority or Other||Odds Ratio (OR)|0.61|||||2-Sided|95.0|0.09|4.34||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.|
1676541|NCT01290445|3084760|Superiority or Other||Odds Ratio (OR)|0.8|||||2-Sided|95.0|0.45|1.42||||||Adjusted prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.|
1676542|NCT01290445|3084760|Superiority or Other||Odds Ratio (OR)|0.82|||||2-Sided|95.0|0.46|1.47||||||Crude prevalence odds ratios were estimated along with 95% confidence intervals using logistic regression models.|
1676543|NCT01290341|3084762|Superiority or Other||p-value|0.001|||<|0.025||95.0|||||Cochran-Mantel-Haenszel|The CMH test statistic after stratification by site was used to compare subjects with complete cure between NAFT-600 and Placebo.||"In order to compare complete cure rate in the NAFT-600 group with that of the Placebo group, the following one-sided hypothesis test was carried out:~H0 (null): p1<=p0 versus Ha (alternate): p1>p0, where p0 and p1 are the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively."|
1676962|NCT01286012|3085382|Superiority or Other|||||||0.915|||||||Cochran-Mantel-Haenszel||||
1676544|NCT01290224|3084781|Non-Inferiority or Equivalence|A one-sided McNemar's test of the primary endpoint with 10 patients will have 86% power at 5% Type I error rate to detect a 60% difference in the percentage of at least 50% reduction in the scrambler and sham procedure, based on the assumption that the proportion of discordant pairs is at 70%.||||||0.763|||||||McNemar|||McNemar's test was used to test for a difference between Scrambler and Sham procedure in their success rate.|
1676545|NCT01290094|3084784|Superiority or Other|||||||0.027||||||Month 24: P-value for percent change from baseline was from a paired samples t-test.|Paired t-test||||
1676546|NCT01290094|3084784|Superiority or Other||||||<|0.0005||||||Month 12: P-value for percent change from baseline was from a paired samples t-test.|Paired t-test||||
1676547|NCT01290094|3084785|Superiority or Other||||||<|0.0005||||||Month 24: P-value for percent change from baseline was from a Wilcoxon signed rank test.|Wilcoxon signed rank test||||
1676548|NCT01290094|3084785|Superiority or Other||||||<|0.0005||||||Month 12: P-value for percent change from baseline was from a Wilcoxon signed rank test.|Wilcoxon signed rank test||||
1676549|NCT01290094|3084786|Superiority or Other|||||||0.056||||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test||||
1676550|NCT01290094|3084787|Superiority or Other|||||||0.001||||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test||||
1676551|NCT01290094|3084788|Superiority or Other||||||<|0.0005||||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test||||
1676552|NCT01290094|3084789|Superiority or Other||||||<|0.0005||||||P-value for percent change from baseline was from a paired samples t-test.|Paired t-test||||
1676553|NCT01289990|3084804|Superiority or Other||Adjusted mean difference|-31.8|Standard Error of the Mean|3.1|<|0.0001|2-Sided|95.0|-37.9|-25.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676554|NCT01289990|3084804|Superiority or Other||Adjusted mean difference|-31.0|Standard Error of the Mean|3.1|<|0.0001|2-Sided|95.0|-37.0|-24.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676555|NCT01289990|3084804|Superiority or Other||Adjusted mean difference|-31.4|Standard Error of the Mean|2.8|<|0.0001|2-Sided|95.0|-36.9|-25.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676556|NCT01289990|3084804|Superiority or Other||Adjusted mean difference|-25.1|Standard Error of the Mean|2.8|<|0.0001|2-Sided|95.0|-30.5|-19.6||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676557|NCT01289990|3084804|Superiority or Other||Adjusted mean difference|-27.4|Standard Error of the Mean|4.1|<|0.0001|2-Sided|95.0|-35.4|-19.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676558|NCT01289990|3084804|Superiority or Other||Adjusted mean difference|-23.3|Standard Error of the Mean|4.1|<|0.0001|2-Sided|95.0|-31.4|-15.3||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676559|NCT01289990|3084804|Superiority or Other||Adjusted mean difference|-18.7|Standard Error of the Mean|3.0|<|0.0001|2-Sided|95.0|-24.5|-12.8||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676560|NCT01289990|3084804|Superiority or Other||Adjusted mean difference|-15.4|Standard Error of the Mean|3.0|<|0.0001|2-Sided|95.0|-21.2|-9.6||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676561|NCT01289990|3084804|Superiority or Other||Adjusted mean difference|-16.3|Standard Error of the Mean|3.0|<|0.0001|2-Sided|95.0|-22.1|-10.5||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676562|NCT01289990|3084804|Superiority or Other||Adjusted mean difference|-34.9|Standard Error of the Mean|2.9|<|0.0001|2-Sided|95.0|-40.7|-29.1||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676563|NCT01289990|3084804|Superiority or Other||Adjusted mean difference|-31.7|Standard Error of the Mean|2.9|<|0.0001|2-Sided|95.0|-37.4|-25.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676564|NCT01289990|3084805|Superiority or Other||Adjusted mean difference|-28.7|Standard Error of the Mean|3.0|<|0.0001|2-Sided|95.0|-34.5|-22.8||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676565|NCT01289990|3084805|Superiority or Other||Adjusted mean difference|-27.8|Standard Error of the Mean|2.9|<|0.0001|2-Sided|95.0|-33.6|-22.0||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676566|NCT01289990|3084805|Superiority or Other||Adjusted mean difference|-27.3|Standard Error of the Mean|2.8|<|0.0001|2-Sided|95.0|-32.7|-21.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676567|NCT01289990|3084805|Superiority or Other||Adjusted mean difference|-24.3|Standard Error of the Mean|2.7|<|0.0001|2-Sided|95.0|-29.7|-18.9||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676568|NCT01289990|3084805|Superiority or Other||Adjusted mean difference|-31.0|Standard Error of the Mean|4.0|<|0.0001|2-Sided|95.0|-38.9|-23.2||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676569|NCT01289990|3084805|Superiority or Other||Adjusted mean difference|-27.1|Standard Error of the Mean|4.0|<|0.0001|2-Sided|95.0|-35.0|-19.2||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676963|NCT01286012|3085383|Superiority or Other||||||<|0.05|||||||ANCOVA||||
1676964|NCT01285713|3085401|Superiority or Other|||||||0.0003|||||||Paired t-test||||
1676570|NCT01289990|3084805|Superiority or Other||Adjusted mean difference|-19.9|Standard Error of the Mean|2.8|<|0.0001|2-Sided|95.0|-25.5|-14.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676571|NCT01289990|3084805|Superiority or Other||Adjusted mean difference|-15.0|Standard Error of the Mean|2.9|<|0.0001|2-Sided|95.0|-20.6|-9.4||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676572|NCT01289990|3084805|Superiority or Other||Adjusted mean difference|-17.3|Standard Error of the Mean|2.8|<|0.0001|2-Sided|95.0|-22.9|-11.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676573|NCT01289990|3084805|Superiority or Other||Adjusted mean difference|-37.2|Standard Error of the Mean|2.8|<|0.0001|2-Sided|95.0|-42.8|-31.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676574|NCT01289990|3084805|Superiority or Other||Adjusted mean difference|-32.3|Standard Error of the Mean|2.8|<|0.0001|2-Sided|95.0|-37.8|-26.7||Model includes baseline fasting plasma glucose, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676575|NCT01289990|3084806|Superiority or Other||Adjusted mean difference|-1.0|Standard Error of the Mean|0.4||0.0178|2-Sided|95.0|-1.9|-0.2||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676576|NCT01289990|3084806|Superiority or Other||Adjusted mean difference|-1.2|Standard Error of the Mean|0.4||0.0049|2-Sided|95.0|-2.1|-0.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676577|NCT01289990|3084806|Superiority or Other||Adjusted mean difference|-1.1|Standard Error of the Mean|0.4||0.0076|2-Sided|95.0|-1.9|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676578|NCT01289990|3084806|Superiority or Other||Adjusted mean difference|-1.6|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|-2.4|-0.8||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676579|NCT01289990|3084806|Superiority or Other||Adjusted mean difference|-0.9|Standard Error of the Mean|0.6|<|0.1238|2-Sided|95.0|-1.9|0.2||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676580|NCT01289990|3084806|Superiority or Other||Adjusted mean difference|-1.4|Standard Error of the Mean|0.6|<|0.0109|2-Sided|95.0|-2.5|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676581|NCT01289990|3084806|Superiority or Other||Adjusted mean difference|-2.1|Standard Error of the Mean|0.6|<|0.0002|2-Sided|95.0|-3.2|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676582|NCT01289990|3084806|Superiority or Other||Adjusted mean difference|-2.0|Standard Error of the Mean|0.6|<|0.0003|2-Sided|95.0|-3.1|-0.9||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676583|NCT01289990|3084806|Superiority or Other||Adjusted mean difference|0.4|Standard Error of the Mean|0.6|<|0.5044|2-Sided|95.0|-0.7|1.5||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676584|NCT01289990|3084806|Superiority or Other||Adjusted mean difference|-1.7|Standard Error of the Mean|0.5|<|0.0019|2-Sided|95.0|-2.8|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676585|NCT01289990|3084806|Superiority or Other||Adjusted mean difference|-1.6|Standard Error of the Mean|0.5|<|0.0028|2-Sided|95.0|-2.7|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676586|NCT01289990|3084807|Superiority or Other||Adjusted mean difference|-1.3|Standard Error of the Mean|0.4||0.0015|2-Sided|95.0|-2.1|-0.5||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676587|NCT01289990|3084807|Superiority or Other||Adjusted mean difference|-1.3|Standard Error of the Mean|0.4||0.001|2-Sided|95.0|-2.1|-0.6||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676588|NCT01289990|3084807|Superiority or Other||Adjusted mean difference|-1.6|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|-2.3|-0.9|||ANCOVA||||
1676589|NCT01289990|3084807|Superiority or Other||Adjusted mean difference|-1.0|Standard Error of the Mean|0.4|<|0.0053|2-Sided|95.0|-1.8|-0.3||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676590|NCT01289990|3084807|Superiority or Other||Adjusted mean difference|-1.0|Standard Error of the Mean|0.5|<|0.0642|2-Sided|95.0|-2.1|0.1||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676591|NCT01289990|3084807|Superiority or Other||Adjusted mean difference|-1.5|Standard Error of the Mean|0.5|<|0.0064|2-Sided|95.0|-2.6|-0.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676592|NCT01289990|3084807|Superiority or Other||Adjusted mean difference|-2.1|Standard Error of the Mean|0.5|<|0.0001|2-Sided|95.0|-3.1|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676593|NCT01289990|3084807|Superiority or Other||Adjusted mean difference|-2.4|Standard Error of the Mean|0.5|<|0.0001|2-Sided|95.0|-3.5|-1.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1677014|NCT01285310|3085544|Superiority or Other (legacy)||Risk Difference (RD)|-2.5|||||||||||||||
1677015|NCT01285310|3085544|Superiority or Other (legacy)||Risk Difference (RD)|-1.3|||||||||||||||
1676594|NCT01289990|3084807|Superiority or Other||Adjusted mean difference|0.4|Standard Error of the Mean|0.5|<|0.5052|2-Sided|95.0|-0.7|1.4||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676595|NCT01289990|3084807|Superiority or Other||Adjusted mean difference|-1.7|Standard Error of the Mean|0.5|<|0.0015|2-Sided|95.0|-2.8|-0.7||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676596|NCT01289990|3084807|Superiority or Other||Adjusted mean difference|-2.1|Standard Error of the Mean|0.5|<|0.0001|2-Sided|95.0|-3.1|-1.0||Model includes baseline waist circumference, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676597|NCT01289990|3084808|Superiority or Other||Adjusted mean difference|-1.64|Standard Error of the Mean|0.27|<|0.0001|2-Sided|95.0|-2.18|-1.11||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676598|NCT01289990|3084808|Superiority or Other||Adjusted mean difference|-1.81|Standard Error of the Mean|0.27|<|0.0001|2-Sided|95.0|-2.34|-1.27||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676599|NCT01289990|3084808|Superiority or Other||Adjusted mean difference|-2.19|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|-2.79|-1.6||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676600|NCT01289990|3084808|Superiority or Other||Adjusted mean difference|-1.93|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|-2.52|-1.34||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676601|NCT01289990|3084808|Superiority or Other||Adjusted mean difference|-1.71|Standard Error of the Mean|0.37|<|0.0001|2-Sided|95.0|-2.43|-0.99||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676602|NCT01289990|3084808|Superiority or Other||Adjusted mean difference|-1.97|Standard Error of the Mean|0.37|<|0.0001|2-Sided|95.0|-2.69|-1.24||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676603|NCT01289990|3084808|Superiority or Other||Adjusted mean difference|-2.56|Standard Error of the Mean|0.28|<|0.0001|2-Sided|95.0|-3.1|-2.01||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676604|NCT01289990|3084808|Superiority or Other||Adjusted mean difference|-2.34|Standard Error of the Mean|0.28|<|0.0001|2-Sided|95.0|-2.89|-1.8||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676605|NCT01289990|3084808|Superiority or Other||Adjusted mean difference|0.54|Standard Error of the Mean|0.28|<|0.0546|2-Sided|95.0|-0.01|1.08||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676606|NCT01289990|3084808|Superiority or Other||Adjusted mean difference|-2.02|Standard Error of the Mean|0.28|<|0.0001|2-Sided|95.0|-2.56|-1.48||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676607|NCT01289990|3084808|Superiority or Other||Adjusted mean difference|-1.81|Standard Error of the Mean|0.28|<|0.0001|2-Sided|95.0|-2.35|-1.26||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676608|NCT01289990|3084809|Superiority or Other||Adjusted mean difference|-2.01|Standard Error of the Mean|0.26|<|0.0001|2-Sided|95.0|-2.52|-1.5||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676609|NCT01289990|3084809|Superiority or Other||Adjusted mean difference|-1.97|Standard Error of the Mean|0.26|<|0.0001|2-Sided|95.0|-2.48|-1.47||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676610|NCT01289990|3084809|Superiority or Other||Adjusted mean difference|-2.3|Standard Error of the Mean|0.28|<|0.0001|2-Sided|95.0|-2.85|-1.76||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676611|NCT01289990|3084809|Superiority or Other||Adjusted mean difference|-1.73|Standard Error of the Mean|0.28|<|0.0001|2-Sided|95.0|-2.27|-1.19||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676612|NCT01289990|3084809|Superiority or Other||Adjusted mean difference|-1.99|Standard Error of the Mean|0.34|<|0.0001|2-Sided|95.0|-2.66|-1.32||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676613|NCT01289990|3084809|Superiority or Other||Adjusted mean difference|-2.09|Standard Error of the Mean|0.34|<|0.0001|2-Sided|95.0|-2.76|-1.41||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676614|NCT01289990|3084809|Superiority or Other||Adjusted mean difference|-2.75|Standard Error of the Mean|0.27|<|0.0001|2-Sided|95.0|-3.28|-2.22|||ANCOVA||||
1676615|NCT01289990|3084809|Superiority or Other||Adjusted mean difference|-2.84|Standard Error of the Mean|0.27|<|0.0001|2-Sided|95.0|-3.37|-2.31||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676616|NCT01289990|3084809|Superiority or Other||Adjusted mean difference|0.62|Standard Error of the Mean|0.27|<|0.0223|2-Sided|95.0|0.09|1.14||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676617|NCT01289990|3084809|Superiority or Other||Adjusted mean difference|-2.14|Standard Error of the Mean|0.27|<|0.0001|2-Sided|95.0|-2.66|-1.61||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676618|NCT01289990|3084809|Superiority or Other||Adjusted mean difference|-2.22|Standard Error of the Mean|0.27|<|0.0001|2-Sided|95.0|-2.75|-1.69||Model includes baseline weight, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1677016|NCT01285310|3085545|Superiority or Other (legacy)||Risk Difference (RD)|-2.2|||||||||||||||
1676619|NCT01289990|3084810|Superiority or Other||Adjusted mean difference|-0.9|Standard Error of the Mean|0.7||0.1785|2-Sided|95.0|-2.2|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676620|NCT01289990|3084810|Superiority or Other||Adjusted mean difference|-1.1|Standard Error of the Mean|0.7||0.0814|2-Sided|95.0|-2.4|0.1||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676621|NCT01289990|3084810|Superiority or Other||Adjusted mean difference|-1.4|Standard Error of the Mean|0.7||0.0677|2-Sided|95.0|-2.8|0.1||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676622|NCT01289990|3084810|Superiority or Other||Adjusted mean difference|-2.0|Standard Error of the Mean|0.7||0.0084|2-Sided|95.0|-3.4|-0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676623|NCT01289990|3084810|Superiority or Other||Adjusted mean difference|-2.2|Standard Error of the Mean|0.8||0.0038|2-Sided|95.0|-3.7|-0.7||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676624|NCT01289990|3084810|Superiority or Other||Adjusted mean difference|-1.5|Standard Error of the Mean|0.8||0.0513|2-Sided|95.0|-3.0|0.0||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676625|NCT01289990|3084810|Superiority or Other||Adjusted mean difference|-1.6|Standard Error of the Mean|0.7||0.0231|2-Sided|95.0|-2.9|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676626|NCT01289990|3084810|Superiority or Other||Adjusted mean difference|-1.5|Standard Error of the Mean|0.7||0.0289|2-Sided|95.0|-2.8|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676627|NCT01289990|3084810|Superiority or Other||Adjusted mean difference|0.5|Standard Error of the Mean|0.7||0.4327|2-Sided|95.0|-0.8|1.9||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676628|NCT01289990|3084810|Superiority or Other||Adjusted mean difference|-1.0|Standard Error of the Mean|0.7||0.1323|2-Sided|95.0|-2.4|0.3||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676629|NCT01289990|3084810|Superiority or Other||Adjusted mean difference|-1.0|Standard Error of the Mean|0.7||0.1568|2-Sided|95.0|-2.3|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676630|NCT01289990|3084811|Superiority or Other||Adjusted mean difference|-0.6|Standard Error of the Mean|0.6||0.3494|2-Sided|95.0|-1.9|0.7||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676631|NCT01289990|3084811|Superiority or Other||Adjusted mean difference|-0.7|Standard Error of the Mean|0.6||0.2523|2-Sided|95.0|-2.0|0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676632|NCT01289990|3084811|Superiority or Other||Adjusted mean difference|-1.7|Standard Error of the Mean|0.7||0.0236|2-Sided|95.0|-3.1|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676633|NCT01289990|3084811|Superiority or Other||Adjusted mean difference|-1.8|Standard Error of the Mean|0.7||0.017|2-Sided|95.0|-3.2|-0.3||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676634|NCT01289990|3084811|Superiority or Other||Adjusted mean difference|-2.6|Standard Error of the Mean|0.7||0.0003|2-Sided|95.0|-4.1|-1.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676635|NCT01289990|3084811|Superiority or Other||Adjusted mean difference|-2.0|Standard Error of the Mean|0.7||0.0076|2-Sided|95.0|-3.4|-0.5||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676636|NCT01289990|3084811|Superiority or Other||Adjusted mean difference|-1.6|Standard Error of the Mean|0.7||0.0212|2-Sided|95.0|-2.9|-0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676637|NCT01289990|3084811|Superiority or Other||Adjusted mean difference|-0.9|Standard Error of the Mean|0.7||0.166|2-Sided|95.0|-2.3|0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676638|NCT01289990|3084811|Superiority or Other||Adjusted mean difference|-0.2|Standard Error of the Mean|0.7||0.8259|2-Sided|95.0|-1.5|1.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676639|NCT01289990|3084811|Superiority or Other||Adjusted mean difference|-1.7|Standard Error of the Mean|0.7||0.0109|2-Sided|95.0|-3.1|-0.4||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676640|NCT01289990|3084811|Superiority or Other||Adjusted mean difference|-1.1|Standard Error of the Mean|0.7||0.1058|2-Sided|95.0|-2.4|0.2||Model includes baseline diastolic blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676641|NCT01289990|3084812|Superiority or Other||Adjusted mean difference|-2.1|Standard Error of the Mean|1.0||0.0288|2-Sided|95.0|-4.1|-0.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1677017|NCT01285310|3085545|Superiority or Other (legacy)||Risk Difference (RD)|-6.5|||||||||||||||
1677018|NCT01285310|3085546|Superiority or Other (legacy)||Risk Difference (RD)|2.1|||||||||||||||
1676642|NCT01289990|3084812|Superiority or Other||Adjusted mean difference|-2.2|Standard Error of the Mean|1.0||0.0213|2-Sided|95.0|-4.1|-0.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676643|NCT01289990|3084812|Superiority or Other||Adjusted mean difference|-3.7|Standard Error of the Mean|1.1||0.0008|2-Sided|95.0|-5.9|-1.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676644|NCT01289990|3084812|Superiority or Other||Adjusted mean difference|-4.4|Standard Error of the Mean|1.1|<|0.0001|2-Sided|95.0|-6.6|-2.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676645|NCT01289990|3084812|Superiority or Other||Adjusted mean difference|-3.7|Standard Error of the Mean|1.2|<|0.0028|2-Sided|95.0|-6.1|-1.3||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676646|NCT01289990|3084812|Superiority or Other||Adjusted mean difference|-2.0|Standard Error of the Mean|1.2|<|0.0987|2-Sided|95.0|-4.5|0.4||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676647|NCT01289990|3084812|Superiority or Other||Adjusted mean difference|-3.8|Standard Error of the Mean|1.1|<|0.0007|2-Sided|95.0|-6.0|-1.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676648|NCT01289990|3084812|Superiority or Other||Adjusted mean difference|-3.7|Standard Error of the Mean|1.1|<|0.0008|2-Sided|95.0|-5.9|-1.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676649|NCT01289990|3084812|Superiority or Other||Adjusted mean difference|0.4|Standard Error of the Mean|1.1|<|0.7241|2-Sided|95.0|-1.8|2.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676650|NCT01289990|3084812|Superiority or Other||Adjusted mean difference|-3.4|Standard Error of the Mean|1.1|<|0.0021|2-Sided|95.0|-5.6|-1.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676651|NCT01289990|3084812|Superiority or Other||Adjusted mean difference|-3.4|Standard Error of the Mean|1.1|<|0.0025|2-Sided|95.0|-5.5|-1.2||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676652|NCT01289990|3084813|Superiority or Other||Adjusted mean difference|-0.69|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.85|-0.53||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676653|NCT01289990|3084813|Superiority or Other||Adjusted mean difference|-0.72|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.87|-0.56|||ANCOVA||||
1676654|NCT01289990|3084813|Superiority or Other||Adjusted mean difference|-0.73|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|-0.88|-0.58||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676655|NCT01289990|3084813|Superiority or Other||Adjusted mean difference|-0.61|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|-0.75|-0.46||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676656|NCT01289990|3084813|Superiority or Other||Adjusted mean difference|-0.69|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.88|-0.5||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676657|NCT01289990|3084813|Superiority or Other||Adjusted mean difference|-0.59|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.79|-0.4||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676658|NCT01289990|3084813|Superiority or Other||Adjusted mean difference|-0.22|Standard Error of the Mean|0.08|<|0.005|2-Sided|95.0|-0.38|-0.07||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676659|NCT01289990|3084813|Superiority or Other||Adjusted mean difference|-0.12|Standard Error of the Mean|0.08|<|0.131|2-Sided|95.0|-0.28|0.04||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676660|NCT01289990|3084813|Superiority or Other||Adjusted mean difference|-0.66|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.82|-0.51||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676661|NCT01289990|3084813|Superiority or Other||Adjusted mean difference|-0.89|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-1.04|-0.73||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676662|NCT01289990|3084813|Superiority or Other||Adjusted mean difference|-0.78|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.94|-0.63||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676663|NCT01289990|3084814|Superiority or Other||Adjusted mean difference|-2.5|Standard Error of the Mean|1.0||0.0096|2-Sided|95.0|-4.4|-0.6||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676664|NCT01289990|3084814|Superiority or Other||Adjusted mean difference|-2.9|Standard Error of the Mean|1.0||0.0031|2-Sided|95.0|-4.8|-1.0||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676665|NCT01289990|3084814|Superiority or Other||Adjusted mean difference|-4.5|Standard Error of the Mean|1.0|<|0.0001|2-Sided|95.0|-6.6|-2.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1677019|NCT01285310|3085546|Superiority or Other (legacy)||Risk Difference (RD)|-5.4|||||||||||||||
1676666|NCT01289990|3084814|Superiority or Other||Adjusted mean difference|-3.0|Standard Error of the Mean|1.0|<|0.0045|2-Sided|95.0|-5.0|-0.9||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676667|NCT01289990|3084814|Superiority or Other||Adjusted mean difference|-3.9|Standard Error of the Mean|1.2|<|0.0019|2-Sided|95.0|-6.4|-1.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676668|NCT01289990|3084814|Superiority or Other||Adjusted mean difference|-2.4|Standard Error of the Mean|1.3|<|0.0543|2-Sided|95.0|-4.9|0.0||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676669|NCT01289990|3084814|Superiority or Other||Adjusted mean difference|-2.8|Standard Error of the Mean|1.1|<|0.0105|2-Sided|95.0|-5.0|-0.7||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676670|NCT01289990|3084814|Superiority or Other||Adjusted mean difference|-3.3|Standard Error of the Mean|1.1|<|0.0033|2-Sided|95.0|-5.4|-1.1||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676671|NCT01289990|3084814|Superiority or Other||Adjusted mean difference|-1.4|Standard Error of the Mean|1.1|<|0.2107|2-Sided|95.0|-3.5|0.8||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676672|NCT01289990|3084814|Superiority or Other||Adjusted mean difference|-4.2|Standard Error of the Mean|1.1|<|0.0001|2-Sided|95.0|-6.4|-2.1||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676673|NCT01289990|3084814|Superiority or Other||Adjusted mean difference|-4.6|Standard Error of the Mean|1.1|<|0.0001|2-Sided|95.0|-6.8|-2.5||Model includes baseline sys blood pressure, baseline HbA1c as covariates, baseline eGFR, geographic region, and treatment as fixed effects.|ANCOVA||||
1676674|NCT01289990|3084815|Superiority or Other||Adjusted mean difference|-0.8|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-1.04|-0.56||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis||||
1676675|NCT01289990|3084815|Superiority or Other||Adjusted mean difference|-0.8|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-1.04|-0.57||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis||||
1676676|NCT01289990|3084815|Superiority or Other||Adjusted mean difference|-0.83|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-1.04|-0.63||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis||||
1676677|NCT01289990|3084815|Superiority or Other||Adjusted mean difference|-0.67|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.87|-0.47||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis||||
1676678|NCT01289990|3084815|Superiority or Other||Adjusted mean difference|-0.72|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-1.0|-0.44||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis||||
1676679|NCT01289990|3084815|Superiority or Other||Adjusted mean difference|-0.62|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-0.9|-0.33||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis||||
1676680|NCT01289990|3084815|Superiority or Other||Adjusted mean difference|-0.61|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-0.83|-0.4||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis||||
1676681|NCT01289990|3084815|Superiority or Other||Adjusted mean difference|-0.29|Standard Error of the Mean|0.1|<|0.0038|2-Sided|95.0|-0.48|-0.09||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis||||
1676682|NCT01289990|3084815|Superiority or Other||Adjusted mean difference|-0.21|Standard Error of the Mean|0.1|<|0.0322|2-Sided|95.0|-0.41|-0.02||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis||||
1676683|NCT01289990|3084815|Superiority or Other||Adjusted mean difference|-0.9|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-1.11|-0.69||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis||||
1676684|NCT01289990|3084815|Superiority or Other||Adjusted mean difference|-0.82|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-1.04|-0.61||Model includes baseline HbA1c as a covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, visit, treatment as fixed effects, and visit by treatment interaction.|Mixed Models Analysis||||
1676685|NCT01289990|3084816|Superiority or Other||Adjusted mean difference|-0.7|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.85|-0.55||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676686|NCT01289990|3084816|Superiority or Other||Adjusted mean difference|-0.74|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.89|-0.59||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676687|NCT01289990|3084816|Superiority or Other||Adjusted mean difference|-0.69|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|-0.83|-0.55||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676688|NCT01289990|3084816|Superiority or Other||Adjusted mean difference|-0.62|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|-0.75|-0.48||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676689|NCT01289990|3084816|Superiority or Other||Adjusted mean difference|-0.68|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.87|-0.49||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676690|NCT01289990|3084816|Superiority or Other||Adjusted mean difference|-0.6|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.79|-0.41||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA||||
1676691|NCT01289990|3084816|Superiority or Other||Adjusted mean difference|-0.24|Standard Error of the Mean|0.08|<|0.0022|2-Sided|95.0|-0.39|-0.09||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52|
1676692|NCT01289990|3084816|Superiority or Other||Adjusted mean difference|-0.12|Standard Error of the Mean|0.08|<|0.1245|2-Sided|95.0|-0.27|0.03||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52|
1676693|NCT01289990|3084816|Superiority or Other||Adjusted mean difference|-0.67|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.82|-0.52||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52|
1676694|NCT01289990|3084816|Superiority or Other||Adjusted mean difference|-0.91|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-1.06|-0.76||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52|
1676695|NCT01289990|3084816|Superiority or Other||Adjusted mean difference|-0.79|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.94|-0.64||Model includes baseline HbA1c as a linear covariate, baseline estimated glomerular filtration rate (eGFR), geographic region, and treatment as fixed effects.|ANCOVA|||statistical analysis at week 52|
1676696|NCT01289847|3084829|Superiority or Other|||||||0.01|||||||one-sample Poisson method||||
1676697|NCT01289847|3084830|Superiority or Other|||||||0.01|||||||one-sample Poisson rate|||For the primary efficacy analysis, the SABI rate for GAMMAPLEX and the upper bound of its one-sided 99% confidence interval (CI) were estimated by using the exact method for a one-sample Poisson rate.|
1676698|NCT01289821|3084836|Superiority or Other||Percentage of Participants|43.9||||0.36|2-Sided|80.0|33.19|55.09|||One-sample exact binomial test|||Null hypothesis: “True probability p of objective tumor response does not exceed p0, p0=0.4.” H0: p<=0.4 One-sided type I error probability of alpha=10%|
1676699|NCT01289782|3084837|Superiority or Other||Mean differences|57.164|Standard Error of the Mean|115.1548||0.62|2-Sided|95.0|-169.1143|283.4414|||Piecewise Linear Model|||Time Missed from Work AUC72|
1676700|NCT01289782|3084837|Superiority or Other||Mean differences|46.399|Standard Error of the Mean|99.7966||0.642|2-Sided|95.0|-149.6374|242.436|||Piecewise linear model|||Time Missed from Work AUC60|
1676701|NCT01289782|3084838|Superiority or Other||Mean differences|-307.722|Standard Error of the Mean|124.1956||0.013|2-Sided|95.0|-551.4006|-64.0429|||Piecewise Linear Model|||Impairment in Daily Activities AUC72|
1676702|NCT01289782|3084838|Superiority or Other||Mean Differences|-278.06|Standard Error of the Mean|105.6088||0.009|2-Sided|95.0|-485.2529|-70.8668|||Piecewise linear model|||Impairment in Daily Activities AUC60|
1676703|NCT01289782|3084839|Superiority or Other||Mean differences|-248.208|Standard Error of the Mean|124.6753||0.047|2-Sided|95.0|-492.8253|-3.5916|||Piecewise Linear Model|||Impairment in Work Productivity AUC72|
1676704|NCT01289782|3084839|Superiority or Other||Mean differences|-230.464|Standard Error of the Mean|105.9203||0.03|2-Sided|95.0|-438.2662|-22.6626|||Piecewise Linear Model|||Impairment in Work Productivity AUC60|
1676705|NCT01289782|3084840|Superiority or Other||Mean differences|-23.8|Standard Error of the Mean|7.2358|<|0.001|2-Sided|95.0|-37.9931|-9.6064|||Piecewise Linear Model|||Fatigue Severity Score AUC72|
1676706|NCT01289782|3084840|Superiority or Other||Mean differences|-20.679|Standard Error of the Mean|6.0979|<|0.001|2-Sided|95.0|-32.6399|-8.7181|||Piecewise-Linear Model Approach|||Fatigue Severity Score AUC60|
1676707|NCT01289782|3084867|Superiority or Other||Difference in proportions of SVR4|25.8|||<|0.001|2-Sided|95.0|16.8|34.8|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR4 between the treatment groups.|
1676708|NCT01289782|3084868|Superiority or Other||Difference in proportions of SVR24|30.1|||<|0.001|2-Sided|95.0|20.8|39.3|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.|
1676709|NCT01289782|3084869|Superiority or Other||Difference in proportions of SVRW72|28.9|||<|0.001|2-Sided|95.0|19.6|38.2|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVRW72 between the treatment groups.|
1676710|NCT01289782|3084870|Superiority or Other||Difference in proportions of SVR12|29.3|||<|0.001|2-Sided|95.0|20.1|38.6|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR12 between the treatment groups.|
1676711|NCT01289574|3084878|Superiority or Other|||||||0.0857|||||||Cochran-Mantel-Haenszel||||
1676712|NCT01289574|3084879|Superiority or Other|||||||0.061|||||||Cochran-Mantel-Haenszel||||
1676713|NCT01289574|3084880|Superiority or Other|||||||0.1919|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) row mean score statistics, adjusting for investigational site|||
1676714|NCT01289119|3084927|Superiority or Other||LS Mean Difference|-0.52|||<|0.001|2-Sided|95.0|-0.75|-0.28|||ANCOVA|ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates.||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.|
1676715|NCT01289119|3084927|Superiority or Other||LS Mean Difference|-0.69|||<|0.001|2-Sided|95.0|-0.87|-0.51||ANCOVA model with treatment as a fixed effect, and baseline HbA1c with baseline metformin dose as covariates.|ANCOVA|||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.|
1677020|NCT01285310|3085547|Superiority or Other (legacy)||Risk Difference (RD)|2.9|||||||||||||||
1676716|NCT01289119|3084927|Superiority or Other||LS Mean Difference|-0.58|||<|0.001|2-Sided|95.0|-0.78|-0.37|||ANCOVA|ANCOVA model with treatment as a fixed effect, and baseline HbA1c as a covariate.||The analysis was conducted at the 2-sided 5% significance level without a multiplicity adjustment.|
1676717|NCT01289015|3084959|Superiority or Other||p-value|0.001|||<|0.025||95.0|||||Cochran-Mantel-Haenszel|The CMH test statistic after stratification was used to compare subjects with complete cure between NAFT-600 and placebo.||"In order to compare complete cure rate in the NAFT-600 group with that of the placebo group, the following one-sided hypothesis test was carried out:~H0 (null): p1<=p0 versus Ha (alternate): p1>p0, where p0 and p1 are the proportions of subjects with complete cure in the proportions of subjects with complete cure in the placebo and NAFT-600 treatment groups respectively."|
1676718|NCT01288911|3084996|Superiority or Other||Hazard Ratio (HR)|0.51||||0.0002|2-Sided|95.0|0.36|0.74|||Log Rank||Estimated by use of Cox proportional hazards model.|Radiographic PFS based on ICR Enzalutamide Vs. Bicalutamide.|
1676719|NCT01288911|3084997|Superiority or Other||Hazard Ratio (HR)|13.91|||<|0.0001|2-Sided|95.0|7.23|26.79|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 90% PSA decline from baseline Enzalutamide Vs. Bicalutamide.|
1676720|NCT01288911|3084998|Superiority or Other||Hazard Ratio (HR)|7.01|||<|0.0001|2-Sided|95.0|4.83|10.16|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 50% PSA decline from baseline Enzalutamide Vs. Bicalutamide.|
1676721|NCT01288911|3084999|Superiority or Other||Hazard Ratio (HR)|5.55|||<|0.0001|2-Sided|95.0|3.96|7.79|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to ≥ 30% PSA decline from baseline Enzalutamide Vs. Bicalutamide.|
1676722|NCT01288911|3085000|Superiority or Other||Hazard Ratio (HR)|5.07|||<|0.0001|2-Sided|95.0|3.18|8.09|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to PSA Enzalutamide Vs. Bicalutamide.|
1676723|NCT01288911|3085001|Superiority or Other||Hazard Ratio (HR)|0.28|||<|0.0001|2-Sided|95.0|0.2|0.39|||Log Rank||Estimated by use of Cox proportional hazards model.|Time to PSA progression Enzalutamide Vs. Bicalutamide.|
1676724|NCT01288911|3085002|Superiority or Other||||||<|0.0001|||||||Wilcoxon rank sum test|||Best PSA Response Enzalutamide Vs. Bicalutamide.|
1676725|NCT01288911|3085003|Superiority or Other||||||<|0.0001|||||||Wilcoxon rank sum test|||PSA Response Enzalutamide Vs. Bicalutamide.|
1676726|NCT01288911|3085004|Superiority or Other||Hazard Ratio (HR)|0.42|||<|0.0001|2-Sided|95.0|0.33|0.55|||Log Rank||Estimated by use of Cox proportional hazards model.|PFS on based investigator assessment Enzalutamide Vs. Bicalutamide.|
1676727|NCT01288911|3085005|Superiority or Other||Hazard Ratio (HR)|0.44|||<|0.0001|2-Sided|95.0|0.34|0.57|||Log Rank||Estimated by use of Cox proportional hazards model.|PFS based on ICR Enzalutamide Vs. Bicalutamide. The (unstratified) log-rank test with an overall significance level of 0.05 (two-sided) was used to compare the PFS of enzalutamide to bicalutamide. The (unstratified) Cox proportional hazards model was used to estimate the hazard ratio of enzalutamide to bicalutamide, calculate the corresponding two-sided 95% confidence intervals and test the hypothesis that the hazard ratio is equal to 1.|
1676728|NCT01288859|3085006|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.01||0.04|2-Sided|95.0|||||ANOVA||||
1676729|NCT01288859|3085007|Superiority or Other||Mean Difference (Final Values)|0.9|Standard Error of the Mean|0.01||0.01|2-Sided|95.0|||||ANOVA|||Statistical analysis was performed using the statistical package SPSS for Windows (version15). By the analysis of variance (ANOVA) for repeated measures the subjective time curves for all measured compounds were compared and tested for the effect of treatment and of time as factors. For all tests, following a significant main effect in the ANOVA, individual means were compared using the Bonferroni test (p < 0.05). Results were considered significant at p < 0.05.|
1676730|NCT01288859|3085008|Non-Inferiority or Equivalence|The results from LC-MS/MS analysis of parent polyphenols were analyzed and expressed as the absolute changes from the baseline to reduce possible effects of inter-subject fasting variability|Mean Difference (Final Values)|1.0|Standard Error of the Mean|0.1||0.02|2-Sided|95.0|||||ANOVA||||
1676731|NCT01288807|3085016|Other||||||>|0.05||||||one-way repeated measure ANOVA|ANOVA||||
1676732|NCT01288807|3085017|Other||||||>|0.05|||||||t-test, 2 sided|||This analysis looks at the pressure threshold measured in pounds per square inch before and after treatment|
1676733|NCT01288807|3085018|Other|two-tailed paired t-test|||||<|0.05|||||||t-test, 2 sided|||This analysis looks at the cold threshold measured in degrees celcius before and after treatment.|
1676734|NCT01288807|3085019|Other|repeated measure ANOVA|||||<|0.01|||||||ANOVA||||
1676735|NCT01288781|3085020|Superiority or Other|||||||0.98||||||P < 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) * 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) * 6 (time: sea level, 3 & 12; high altitude, 3, 12, 24 & 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug * time interaction.|
1676736|NCT01288781|3085021|Superiority or Other|||||||0.98||||||P < 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) * 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) * 6 (time: sea level, 3 & 12; high altitude, 3, 12, 24 & 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug * time interaction.|
1676737|NCT01288781|3085022|Superiority or Other|||||||0.98||||||P < 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) * 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) * 6 (time: sea level, 3 & 12; high altitude, 3, 12, 24 & 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug * time interaction.|
1676738|NCT01288781|3085023|Superiority or Other||||||<|0.01||||||Step down Holm Bonferroni correction was applied|t-test, 2 sided|||Post hoc follow up test. T test between acetazolamide and placebo on data at 24 hr time point.|
1677021|NCT01285310|3085547|Superiority or Other (legacy)||Risk Difference (RD)|-3.9|||||||||||||||
1677022|NCT01285310|3085548|Superiority or Other (legacy)||Risk Difference (RD)|13.4|||||||||||||||
1676739|NCT01288781|3085023|Superiority or Other||||||<|0.01||||||P < 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) * 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) * 6 (time: sea level, 3 & 12; high altitude, 3, 12, 24 & 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug * time interaction.|
1676740|NCT01288781|3085024|Superiority or Other|||||||0.2||||||P < 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) * 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) * 6 (time: sea level, 3 & 12; high altitude, 3, 12, 24 & 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug * time interaction.|
1676741|NCT01288781|3085025|Superiority or Other|||||||0.63||||||P < 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) * 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) * 6 (time: sea level, 3 & 12; high altitude, 3, 12, 24 & 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug * time interaction.|
1676742|NCT01288781|3085026|Superiority or Other|||||||0.98||||||P < 0.05 considered statistically significant.|ANOVA|Adjustments to the degrees of freedom were made when assumptions of sphericity were violated.||Omnibus analysis was performed. 2 (drug: Acetazolamide versus placebo) * 2 (susceptibility: high altitude headache resistant versus high altitude headache susceptible) * 6 (time: sea level, 3 & 12; high altitude, 3, 12, 24 & 36 hours) analysis of variance with repeated measures on the third factor. Data presented here are for the drug * time interaction.|
1676743|NCT01288612|3085028|Superiority or Other|||||||0.001|||||||Kruskal-Wallis||||
1676744|NCT01288612|3085029|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||Comparison between arms for overall tolerance scale|
1676745|NCT01288612|3085029|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||Comparison between the arms for anxiety scale|
1676746|NCT01288612|3085029|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||Comparison between the arms for gagging scale|
1676747|NCT01288612|3085029|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||Comparison between the arms for choking scale|
1676748|NCT01288612|3085029|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||Comparison between the arms for pain scale|
1676749|NCT01288612|3085030|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis||||
1676750|NCT01288612|3085031|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis||||
1676751|NCT01288612|3085032|Superiority or Other|||||||0.001|||||||Kruskal-Wallis||||
1676752|NCT01288612|3085033|Superiority or Other|||||||0.08|||||||Fisher Exact||||
1676753|NCT01288612|3085034|Superiority or Other|||||||0.06|||||||Kruskal-Wallis||||
1676754|NCT01288612|3085035|Superiority or Other|||||||0.82|||||||Chi-squared||||
1676755|NCT01288612|3085035|Superiority or Other|||||||0.27|||||||Chi-squared||||
1676756|NCT01288612|3085035|Superiority or Other|||||||0.42|||||||Chi-squared||||
1676757|NCT01288612|3085035|Superiority or Other|||||||0.25|||||||Chi-squared||||
1676758|NCT01288521|3085041|Superiority|The null hypothesis is that the tacrolimus biovailability alone is equal to the tacrolimus bioavailability when given with ketoconazole.||||||0.006|||||||Regression, Linear|The bioavailability with Tac alone vs. Tac +keto was compared using linear model adjusting for sex and creatinine clearance.||The bioavailability of Tac alone vs. Tac +keto was compared using a general linear model including sex and creatinine clearance as covariates.|
1676759|NCT01288469|3085048|Superiority or Other||LS Mean Difference|-55.82|||<|0.0001|2-Sided|95.0|-65.62|-46.03||Threshold for significance ≤0.05.|ANCOVA||Alirocumab vs. placebo|Throughout the ANCOVA model, the Alirocumab + atorvastatin 80 mg group was compared to the placebo + atorvastatin 80 mg group using appropriate contrast and the 95% confidence interval (CI) of the difference was provided.|
1676760|NCT01288443|3085055|Superiority or Other||||||<|0.0001||||||Threshold for significance ≤ 0.05.|ANCOVA||||
1676761|NCT01288443|3085055|Superiority or Other||||||<|0.0001||||||Threshold for significance ≤ 0.05.|ANCOVA||||
1676762|NCT01288443|3085055|Superiority or Other||||||<|0.0001||||||Threshold for significance ≤ 0.05.|ANCOVA||||
1676763|NCT01288443|3085055|Superiority or Other||||||<|0.0001||||||Threshold for significance ≤ 0.05.|ANCOVA||||
1676764|NCT01288443|3085055|Superiority or Other||||||<|0.0001||||||Threshold for significance ≤ 0.05.|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~Alirocumab 150 mg Q2W versus placebo~Alirocumab 300 mg Q4W versus placebo~Alirocumab 100 mg Q2W versus placebo~Alirocumab 200 mg Q4W versus placebo~Alirocumab 50 mg Q2W versus placebo~Testing continued only when high-order test was statistically significant at 5% level"|
1676765|NCT01288079|3085072|Superiority or Other||LS mean|-3.9|Standard Error of the Mean|2.95||0.194|2-Sided|95.0|-9.72|2.0|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.|
1676766|NCT01288079|3085072|Superiority or Other||LS mean|-3.6|Standard Error of the Mean|3.26||0.277|2-Sided|95.0|-10.06|2.91|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.|
1677009|NCT01285310|3085541|Superiority or Other (legacy)||LS Mean Difference|-0.12|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.||
1676767|NCT01288079|3085072|Superiority or Other||LS mean|-1.5|Standard Error of the Mean|2.95||0.617|2-Sided|95.0|-7.35|4.39|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit, treatment by visit interaction, region, responsiveness, and region by responsiveness as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit treatment by visit interaction, region, responsiveness, and region by responsiveness are fixed effects in the model; pooled center is a random effect.|
1676768|NCT01288027|3085080|Superiority or Other|||||||0.186|||||||one sample t-test|||Statistical significance for change from Baseline was measured using one sample t-test|
1676769|NCT01287897|3085085|Superiority or Other||Mean Difference (Final Values)|-31.0|Standard Error of the Mean|19.87||0.0598|2-Sided|90.0|-63.9|1.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 12.|
1676770|NCT01287897|3085085|Superiority or Other||Mean Difference (Final Values)|-29.9|Standard Error of the Mean|19.64||0.0649|2-Sided|90.0|-62.3|2.6|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 10.|
1676771|NCT01287897|3085085|Superiority or Other||Mean Difference (Final Values)|-9.0|Standard Error of the Mean|19.27||0.3204|2-Sided|90.0|-40.8|22.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 8.|
1676772|NCT01287897|3085085|Superiority or Other||Mean Difference (Final Values)|-5.6|Standard Error of the Mean|18.79||0.3837|2-Sided|90.0|-36.6|25.5|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 6.|
1676773|NCT01287897|3085085|Superiority or Other||Mean Difference (Final Values)|-3.8|Standard Error of the Mean|18.28||0.4171|2-Sided|90.0|-34.0|26.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 4.|
1676774|NCT01287897|3085085|Superiority or Other||Mean Difference (Final Values)|-8.8|Standard Error of the Mean|18.27||0.3157|2-Sided|90.0|-39.0|21.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 200-mg arm at Week 2.|
1676775|NCT01287897|3085086|Superiority or Other||Mean Difference (Final Values)|-39.5|Standard Error of the Mean|19.49||0.0221|2-Sided|90.0|-71.7|-7.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 12.|
1676776|NCT01287897|3085086|Superiority or Other||Mean Difference (Final Values)|-44.9|Standard Error of the Mean|19.45||0.0111|2-Sided|90.0|-77.1|-12.7|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 10.|
1676777|NCT01287897|3085086|Superiority or Other||Mean Difference (Final Values)|-28.8|Standard Error of the Mean|17.43||0.0499|2-Sided|90.0|-57.7|0.0|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 8.|
1676778|NCT01287897|3085086|Superiority or Other||Mean Difference (Final Values)|-22.4|Standard Error of the Mean|16.12||0.0834|2-Sided|90.0|-49.0|4.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 6.|
1676779|NCT01287897|3085086|Superiority or Other||Mean Difference (Final Values)|-25.7|Standard Error of the Mean|12.93||0.0243|2-Sided|90.0|-47.0|-4.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 4.|
1676780|NCT01287897|3085086|Superiority or Other||Mean Difference (Final Values)|2.7|Standard Error of the Mean|12.25||0.5868|2-Sided|90.0|-17.6|22.9|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 50-mg arm at Week 2.|
1676781|NCT01287897|3085086|Superiority or Other||Mean Difference (Final Values)|-16.8|Standard Error of the Mean|19.71||0.1975|2-Sided|90.0|-49.4|15.8|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 12.|
1676782|NCT01287897|3085086|Superiority or Other||Mean Difference (Final Values)|-30.2|Standard Error of the Mean|19.66||0.0632|2-Sided|90.0|-62.7|2.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 10.|
1676783|NCT01287897|3085086|Superiority or Other||Mean Difference (Final Values)|-14.9|Standard Error of the Mean|17.66||0.1993|2-Sided|90.0|-44.1|14.3|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 8.|
1676784|NCT01287897|3085086|Superiority or Other||Mean Difference (Final Values)|-15.9|Standard Error of the Mean|16.37||0.1661|2-Sided|90.0|-43.0|11.2|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 6.|
1676785|NCT01287897|3085086|Superiority or Other||Mean Difference (Final Values)|-12.0|Standard Error of the Mean|12.95||0.1778|2-Sided|90.0|-33.4|9.4|||LMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 4.|
1676806|NCT01287897|3085089|Superiority or Other||Mean Difference (Final Values)|5.4|Standard Error of the Mean|9.0||0.2721||90.0|-9.3|20.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 10.|
1676786|NCT01287897|3085086|Superiority or Other||Mean Difference (Final Values)|-9.6|Standard Error of the Mean|12.22||0.2173|2-Sided|90.0|-29.8|10.6|||Linear mixed model (LMM)|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in change from baseline in CDAI score for the 10-mg arm at Week 2.|
1676787|NCT01287897|3085087|Superiority or Other||Mean Difference (Final Values)|7.4|Standard Error of the Mean|11.7||0.2622|2-Sided|90.0|-11.8|26.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 12.|
1676788|NCT01287897|3085087|Superiority or Other||Mean Difference (Final Values)|12.3|Standard Error of the Mean|12.3||0.1601||90.0|-8.0|32.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 10.|
1676789|NCT01287897|3085087|Superiority or Other||Mean Difference (Final Values)|-2.7|Standard Error of the Mean|10.3||0.6019|2-Sided|90.0|-19.5|14.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 8.|
1676790|NCT01287897|3085087|Superiority or Other||Mean Difference (Final Values)|9.9|Standard Error of the Mean|10.0||0.16|2-Sided|90.0|-6.5|26.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 6.|
1676791|NCT01287897|3085087|Superiority or Other||Mean Difference (Final Values)|11.1|Standard Error of the Mean|9.6||0.1219|2-Sided|90.0|-4.6|26.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 4.|
1676792|NCT01287897|3085087|Superiority or Other||Mean Difference (Final Values)|1.7|Standard Error of the Mean|6.8||0.4031|2-Sided|90.0|-9.5|12.9|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 200-mg arm at Week 2.|
1676793|NCT01287897|3085088|Superiority or Other||Mean Difference (Final Values)|14.0|Standard Error of the Mean|10.5||0.092|2-Sided|90.0|-3.3|31.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 12.|
1676794|NCT01287897|3085088|Superiority or Other||Mean Difference (Final Values)|17.2|Standard Error of the Mean|10.8||0.0549|2-Sided|90.0|-0.5|35.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 10.|
1676795|NCT01287897|3085088|Superiority or Other||Mean Difference (Final Values)|13.8|Standard Error of the Mean|10.7||0.0988|2-Sided|90.0|-3.8|31.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 8.|
1676796|NCT01287897|3085088|Superiority or Other||Mean Difference (Final Values)|17.7|Standard Error of the Mean|9.3||0.029|2-Sided|90.0|2.3|33.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 6.|
1676797|NCT01287897|3085088|Superiority or Other||Mean Difference (Final Values)|13.2|Standard Error of the Mean|8.6||0.0619|2-Sided|90.0|-0.9|27.4|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 4.|
1676798|NCT01287897|3085088|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|6.5||0.4893|2-Sided|90.0|-10.5|10.9|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 50-mg arm at Week 2.|
1676799|NCT01287897|3085088|Superiority or Other||Mean Difference (Final Values)|10.5|Standard Error of the Mean|10.3||0.1541|2-Sided|90.0|-6.5|27.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 12.|
1676800|NCT01287897|3085088|Superiority or Other||Mean Difference (Final Values)|8.9|Standard Error of the Mean|10.2||0.1921||90.0|-7.9|25.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 10.|
1676801|NCT01287897|3085088|Superiority or Other||Mean Difference (Final Values)|2.4|Standard Error of the Mean|9.9||0.4036|2-Sided|90.0|-13.8|18.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 8.|
1676802|NCT01287897|3085088|Superiority or Other||Mean Difference (Final Values)|14.2|Standard Error of the Mean|9.3||0.0633|2-Sided|90.0|-1.1|29.5|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 6.|
1676803|NCT01287897|3085088|Superiority or Other||Mean Difference (Final Values)|5.1|Standard Error of the Mean|7.4||0.246|2-Sided|90.0|-7.1|17.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 4.|
1676804|NCT01287897|3085088|Superiority or Other||Mean Difference (Final Values)|4.3|Standard Error of the Mean|7.0||0.2687|2-Sided|90.0|-7.2|15.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-100 response rate for the 10-mg arm at Week 2.|
1676805|NCT01287897|3085089|Superiority or Other||Mean Difference (Final Values)|4.0|Standard Error of the Mean|7.8||0.3022|2-Sided|90.0|-8.8|16.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 12.|
1676851|NCT01287416|3085140|Superiority or Other|||||||0.33||||||A priori threshold for significance set at p<.05.|Chi-squared||||
1676807|NCT01287897|3085089|Superiority or Other||Mean Difference (Final Values)|-3.2|Standard Error of the Mean|7.5||0.6637|2-Sided|90.0|-15.5|9.1|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 8.|
1676808|NCT01287897|3085089|Superiority or Other||Mean Difference (Final Values)|2.7|Standard Error of the Mean|6.3||0.3324|2-Sided|90.0|-7.7|13.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 6.|
1676809|NCT01287897|3085089|Superiority or Other||Mean Difference (Final Values)|2.7|Standard Error of the Mean|4.3||0.2623|2-Sided|90.0|-4.3|9.8|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 4.|
1676810|NCT01287897|3085089|Superiority or Other||Mean Difference (Final Values)|5.8|Standard Error of the Mean|5.3||0.1342|2-Sided|90.0|-2.8|14.5|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 200-mg arm at Week 2.|
1676811|NCT01287897|3085090|Superiority or Other||Mean Difference (Final Values)|16.5|Standard Error of the Mean|9.5||0.0408|2-Sided|90.0|0.9|32.1|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 12.|
1676812|NCT01287897|3085090|Superiority or Other||Mean Difference (Final Values)|17.8|Standard Error of the Mean|10.3||0.0415|2-Sided|90.0|0.9|34.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 10.|
1676813|NCT01287897|3085090|Superiority or Other||Mean Difference (Final Values)|8.5|Standard Error of the Mean|9.6||0.1866|2-Sided|90.0|-7.2|24.3|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 8.|
1676814|NCT01287897|3085090|Superiority or Other||Mean Difference (Final Values)|14.9|Standard Error of the Mean|8.5||0.0399|2-Sided|90.0|0.9|28.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 6.|
1676815|NCT01287897|3085090|Superiority or Other||Mean Difference (Final Values)|16.3|Standard Error of the Mean|7.6||0.0155|2-Sided|90.0|3.9|28.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 4.|
1676816|NCT01287897|3085090|Superiority or Other||Mean Difference (Final Values)|8.0|Standard Error of the Mean|4.9||0.0498|2-Sided|90.0|0.0|16.0|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 50-mg arm at Week 2.|
1676817|NCT01287897|3085090|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|7.1||0.5038|2-Sided|90.0|-11.8|11.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 12.|
1676818|NCT01287897|3085090|Superiority or Other||Mean Difference (Final Values)|6.8|Standard Error of the Mean|9.2||0.2308||90.0|-8.3|21.9|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 10.|
1676819|NCT01287897|3085090|Superiority or Other||Mean Difference (Final Values)|-5.5|Standard Error of the Mean|8.0||0.7544|2-Sided|90.0|-18.8|7.7|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 8.|
1676820|NCT01287897|3085090|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|6.0||0.5791|2-Sided|90.0|-11.0|8.6|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 6.|
1676821|NCT01287897|3085090|Superiority or Other||Mean Difference (Final Values)|0.7|Standard Error of the Mean|3.8||0.4291|2-Sided|90.0|-5.6|7.0|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 4.|
1676822|NCT01287897|3085090|Superiority or Other||Mean Difference (Final Values)|2.0|Standard Error of the Mean|3.2||0.261|2-Sided|90.0|-3.2|7.2|||GLMM|Status of anti-TNF experience and concomitant immunosuppressant therapy were included as covariates.||LSM difference from placebo in CDAI remission rate for the 10-mg arm at Week 2.|
1676823|NCT01287897|3085091|Superiority or Other||Mean Difference (Final Values)|19.1|Standard Error of the Mean|14.1||0.088|2-Sided|90.0|-4.1|42.3|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 10.|
1676824|NCT01287897|3085091|Superiority or Other||Mean Difference (Final Values)|7.8|Standard Error of the Mean|11.1||0.2416|2-Sided|90.0|-10.5|26.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 6.|
1676825|NCT01287897|3085091|Superiority or Other||Mean Difference (Final Values)|9.5|Standard Error of the Mean|10.0||0.1708|2-Sided|90.0|-6.9|25.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 4.|
1676826|NCT01287897|3085091|Superiority or Other||Mean Difference (Final Values)|15.4|Standard Error of the Mean|10.2||0.0662|2-Sided|90.0|-1.4|32.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 200-mg arm at Week 2.|
1676827|NCT01287897|3085092|Superiority or Other||Mean Difference (Final Values)|24.7|Standard Error of the Mean|11.2||0.0138|2-Sided|90.0|6.2|43.1|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 10.|
1676828|NCT01287897|3085092|Superiority or Other||Mean Difference (Final Values)|25.1|Standard Error of the Mean|10.1||0.0063|2-Sided|90.0|8.6|41.7|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 6.|
1676829|NCT01287897|3085092|Superiority or Other||Mean Difference (Final Values)|20.6|Standard Error of the Mean|9.3||0.0132|2-Sided|90.0|5.3|35.8|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 4.|
1676830|NCT01287897|3085092|Superiority or Other||Mean Difference (Final Values)|5.8|Standard Error of the Mean|6.8||0.1981|2-Sided|90.0|-5.4|17.0|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 50-mg arm at Week 2.|
1676831|NCT01287897|3085092|Superiority or Other||Mean Difference (Final Values)|9.6|Standard Error of the Mean|11.0||0.1909||90.0|-8.4|27.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 10.|
1676832|NCT01287897|3085092|Superiority or Other||Mean Difference (Final Values)|13.9|Standard Error of the Mean|9.9||0.0792|2-Sided|90.0|-2.3|30.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 6.|
1676833|NCT01287897|3085092|Superiority or Other||Mean Difference (Final Values)|18.1|Standard Error of the Mean|9.1||0.0235|2-Sided|90.0|3.1|33.2|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 4.|
1676834|NCT01287897|3085092|Superiority or Other||Mean Difference (Final Values)|7.1|Standard Error of the Mean|7.0||0.1527|2-Sided|90.0|-4.3|18.6|||GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.||LSM difference from placebo in CDAI-70 response rate for the 10-mg arm at Week 2.|
1676835|NCT01287897|3085093|Superiority or Other||Mean Difference (Final Values)|15.1|Standard Error of the Mean|13.7||0.1362|2-Sided|90.0|-7.5|37.6||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.|||
1676836|NCT01287897|3085094|Superiority or Other||Mean Difference (Final Values)|18.8|Standard Error of the Mean|10.9||0.0425|2-Sided|90.0|0.8|36.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.|||
1676837|NCT01287897|3085094|Superiority or Other||Mean Difference (Final Values)|6.7|Standard Error of the Mean|10.5||0.2627|2-Sided|90.0|-10.6|23.9||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.|||
1676838|NCT01287897|3085095|Superiority or Other||Mean Difference (Final Values)|10.2|Standard Error of the Mean|13.6||0.2258|2-Sided|90.0|-12.1|32.6||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.|||
1676839|NCT01287897|3085096|Superiority or Other||Mean Difference (Final Values)|18.7|Standard Error of the Mean|11.0||0.0438|2-Sided|90.0|0.7|36.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|GLMM|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.|||
1676840|NCT01287897|3085096|Superiority or Other||Mean Difference (Final Values)|4.3|Standard Error of the Mean|10.5||0.3406|2-Sided|90.0|-13.0|21.7||Type I rate was controlled for the 2 time points (Week 8 and Week 12) at 0.05 (one sided).|Generalized linear mixed model (GLMM)|Status of anti-TNF experience, concomitant immunosuppressant therapy, and baseline were included as covariates.|||
1676841|NCT01287741|3085118|Superiority or Other||Hazard Ratio (HR)|0.89||||0.2736|2-Sided|95.0|0.72|1.1|||Log Rank|Stratified by International Prognostic Index (IPI) score (low/low−intermediate (excluding participants having an IPI score 0 without bulky disease).|||
1676842|NCT01287741|3085119|Superiority or Other||Hazard Ratio (HR)|0.94||||0.4753|2-Sided|95.0|0.78|1.12|||Log Rank|Stratified by International Prognostic Index (IPI) score (low/low−intermediate (excluding participants having an IPI score 0 without bulky disease).|||
1676843|NCT01287611|3085120|Non-Inferiority or Equivalence|Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.||||||0.001|||||||t-test, 2 sided||||
1676844|NCT01287611|3085121|Non-Inferiority or Equivalence|Group sample sizes of 51 in study group and 65 in control group achieve 98% power to detect a difference between the group proportions of -0.3300. The proportion in study group is assumed to be 0.4800 under the null hypothesis and 0.1500 under the alternative hypothesis. The proportion in control group is 0.4800. The test statistic used is the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.0500.||||||0.0001|||||||Chi-squared||||
1676845|NCT01287416|3085133|Superiority or Other|||||||0.41||||||A priori threshold for significance set at p<.05.|Chi-squared|Unadjusted model||Null hypothesis was that the groups would not differ on gatekeeper behaviours.|
1676846|NCT01287416|3085134|Superiority or Other|||||||0.14||||||a priori threshold for significance set a p<.05.|Fisher Exact|unadjusted model||Null hypothesis was that the groups would not differ in terms of their gatekeeper behaviours|
1676847|NCT01287416|3085136|Superiority or Other|||||||0.064||||||A priori threshold for significance set to p<.05.|Fisher Exact||||
1676848|NCT01287416|3085137|Superiority or Other|||||||1||||||A priori threshold for significance set to p<.05.|Fisher Exact||||
1676849|NCT01287416|3085138|Superiority or Other|||||||1||||||A priori threshold for significance set to p<.05.|Fisher Exact||||
1676850|NCT01287416|3085139|Superiority or Other|||||||0.62||||||A priori threshold for significance set at p<.05.|Chi-squared||||
1676852|NCT01287416|3085141|Superiority or Other|||||||0.28||||||The a priori threshold for statistical significance was set at p<.05.|ANCOVA|Model is adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ in resiliency scores across the follow-up period.|
1676853|NCT01287416|3085142|Superiority or Other|||||||0.46||||||A priori threshold for significance set at p<.05.|ANCOVA|Model was adjusted for differences in educational attainment at baseline.||Null hypothesis was that the groups would not differ in terms of alcohol use across the two time points.|
1676854|NCT01287416|3085143|Superiority or Other|||||||0.21||||||A priori threshold for significance set to p<.05.|ANCOVA|Model adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ on their level of distress across the two time points.|
1676855|NCT01287416|3085144|Superiority or Other|||||||0.63||||||The a priori threshold for statistical significance was set at p<.05. Effect size determined by partial eta-squared to be 0.01.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ on level of self-reported preparedness to help a suicidal person.|
1676856|NCT01287416|3085145|Superiority or Other|||||||0.03||||||The a priori threshold for statistical significance was set at p<.05. Effect size determined by partial eta-squared to be 0.05.|Mixed Models Analysis|Model adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of level of knowledge across the three time points.|
1676857|NCT01287416|3085146|Superiority or Other|||||||0.33||||||The a priori threshold for statistical significance was set at p<.05. Effect size determined by partial eta-squared to be 0.02.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the two groups would not differ in terms of self-reported skill level across the three time points.|
1676858|NCT01287416|3085147|Superiority or Other|||||||0.95||||||The a priori threshold for statistical significance was set at p<.05. Effect size determined by partial eta-squared to be 0.02.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of level of knowledge across the three time points.|
1676859|NCT01287416|3085148|Superiority or Other|||||||0.61||||||The a priori threshold for statistical significance was set at p<.05. Effect size determined by partial eta-squared to be 0.01.|Mixed Models Analysis|Model was adjusted for differences in educational attainment at baseline.||The null hypothesis was that the groups would not differ in terms of SIRI scores across the three time points. We used linear mixed models to determine whether scores were different between the two groups over time.|
1676860|NCT01287221|3085160|Superiority or Other|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.|
1676861|NCT01287221|3085161|Superiority or Other|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.|
1676862|NCT01287221|3085162|Superiority or Other|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.|
1676863|NCT01287221|3085163|Superiority or Other|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.|
1676864|NCT01287221|3085164|Superiority or Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.|
1676865|NCT01287221|3085165|Superiority or Other|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.|
1676866|NCT01287221|3085166|Superiority or Other|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Given that there were no imbalances identified between the two groups at baseline and the slope estimates for the two treatment arms did not support assumption of normality, the analysis was performed using Wilcoxon rank-sum test.|
1676867|NCT01287208|3085168|Superiority|||||||0.59|||||||t-test, 2 sided||||
1676868|NCT01287208|3085171|Superiority|||||||0.16|||||||Wilcoxon (Mann-Whitney)||||
1676869|NCT01287117|3085180|Superiority or Other||||||<|0.0001||||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1676870|NCT01287117|3085180|Superiority or Other||||||<|0.2087||||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.|
1676871|NCT01287117|3085180|Superiority or Other||||||<|0.458||||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.|
1676872|NCT01287117|3085181|Superiority or Other||||||<|0.0001||||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1676873|NCT01287117|3085181|Superiority or Other||||||<|0.1747||||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.|
1676874|NCT01287117|3085181|Superiority or Other||||||<|0.4867||||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.|
1676875|NCT01287117|3085182|Superiority or Other||Least squares mean difference|-4.08|||<|0.0001|2-Sided|95.0|-5.96|-2.2||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1676876|NCT01287117|3085182|Superiority or Other||Least squares mean difference|-1.31|||<|0.2286|2-Sided|95.0|-3.46|0.84||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.|
1676877|NCT01287117|3085182|Superiority or Other||Least squares mean difference|0.26|||<|0.7956|2-Sided|95.0|-1.76|2.28||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.|
1676878|NCT01287117|3085183|Superiority or Other||Least squares mean difference|-5.73|||<|0.0001|2-Sided|95.0|-7.59|-3.87||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1676879|NCT01287117|3085183|Superiority or Other||Least squares mean difference|-3.16|||<|0.0012|2-Sided|95.0|-5.05|-1.27||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.|
1676880|NCT01287117|3085183|Superiority or Other||Least squares mean difference|-2.34|||<|0.0124|2-Sided|95.0|-4.17|-0.51||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.|
1676881|NCT01287117|3085184|Superiority or Other||||||<|0.0001||||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1676882|NCT01287117|3085184|Superiority or Other||||||<|0.0226||||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.|
1676883|NCT01287117|3085184|Superiority or Other||||||<|0.0118||||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.|
1676884|NCT01287117|3085185|Superiority or Other||||||<|0.0001||||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1676885|NCT01287117|3085185|Superiority or Other||||||<|0.0001||||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.|
1676886|NCT01287117|3085185|Superiority or Other||||||<|0.0148||||||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups. The p-value was not evaluated for statistical significance in accordance with the type I error rate control plan.|
1676887|NCT01287117|3085186|Superiority or Other||Hazard Ratio (HR)|2.34|||<|0.0001|2-Sided|95.0|1.63|3.36||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1676888|NCT01287117|3085186|Superiority or Other||Hazard Ratio (HR)|1.49|||<|0.0301|2-Sided|95.0|1.04|2.14||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.|
1676889|NCT01287117|3085186|Superiority or Other||Hazard Ratio (HR)|1.39|||<|0.0879|2-Sided|95.0|0.95|2.03||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.|
1676890|NCT01287117|3085187|Superiority or Other||Least squares mean difference|-6.93|||<|0.0001|2-Sided|95.0|-9.1|-4.76||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1676891|NCT01287117|3085187|Superiority or Other||Least squares mean difference|-3.44|||<|0.0017|2-Sided|95.0|-5.57|-1.32||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.|
1676892|NCT01287117|3085187|Superiority or Other||Least squares mean difference|-2.75|||<|0.0149|2-Sided|95.0|-4.95|-0.54||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.|
1676893|NCT01287117|3085188|Superiority or Other||Least squares mean difference|-12.8|||<|0.0001|2-Sided|95.0|-16.44|-9.16||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1676894|NCT01287117|3085188|Superiority or Other||Least squares mean difference|-6.54|||<|0.0008|2-Sided|95.0|-10.33|-2.75||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.|
1676895|NCT01287117|3085188|Superiority or Other||Least squares mean difference|-5.75|||<|0.0035|2-Sided|95.0|-9.59|-1.92||A pre-specified hierarchical order of testing was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided) within each dose.|ANCOVA|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.|
1676955|NCT01286168|3085358|Superiority or Other|||||||0.13|||||||McNemar|||Antisepsis and Control sides were compared.|
1676956|NCT01286168|3085359|Superiority or Other|||||||0.003|||||||McNemar|||Antisepsis and Control sides were compared.|
1677010|NCT01285310|3085542|Superiority or Other (legacy)||Risk Difference (RD)|1.5|||||2-Sided||||||||||
1676896|NCT01287117|3085189|Superiority or Other||Least squares mean difference|-5.8|||<|0.0001|2-Sided|95.0|-7.49|-4.1||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1676897|NCT01287117|3085189|Superiority or Other||Least squares mean difference|-2.95|||<|0.0012|2-Sided|95.0|-4.72|-1.18||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 150 mg groups.|
1676898|NCT01287117|3085189|Superiority or Other||Least squares mean difference|-2.96|||<|0.001|2-Sided|95.0|-4.71|-1.21||A multiplicity type I error control plan was employed to adjust for the comparison of multiple omalizumab groups to the placebo group in order to maintain an overall type I error rate of 0.05 (2-sided).|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 75 mg groups.|
1676899|NCT01287065|3085202|Superiority or Other||Mean Difference (Final Values)|-0.044|||||2-Sided|90.0|-0.125|0.036|||||Mean difference =FF/VI 100/25 µg AM minusFF/VI 100/25 µg PM||
1676900|NCT01287065|3085202|Superiority or Other||Mean Difference (Final Values)|0.422|||||2-Sided|90.0|0.337|0.507|||||Mean difference =FF/VI 100/25 µg AM minus Placebo||
1676901|NCT01287065|3085202|Superiority or Other||Mean Difference (Final Values)|0.377|||||2-Sided|90.0|0.293|0.462|||||Mean difference =FF/VI 100/25 µg PM minus Placebo||
1676902|NCT01287039|3085206|Superiority or Other||CAE rate ratio (reslizumab vs placebo)|0.6595||||0.2572|2-Sided|95.0|0.321|1.355||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Hospitalization or ER visit The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.|
1676903|NCT01287039|3085206|Superiority or Other||CAE rate ratio (reslizumab vs placebo)|0.4499|||<|0.0001|2-Sided|95.0|0.3255|0.622||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Requiring Systemic Corticosteroids The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.|
1676904|NCT01287039|3085208|Superiority or Other||Mean Difference (Final Values)|-0.455|Standard Error of the Mean|0.0182|<|0.0001|2-Sided|95.0|-0.491|-0.419|||Mixed model repeated measures|||"Eosinophil Count Over 52 Weeks~Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures."|
1676905|NCT01287039|3085208|Superiority or Other||Mean Difference (Final Values)|-0.466|Standard Error of the Mean|0.0244|<|0.0001|2-Sided|95.0|-0.514|-0.418|||Mixed model repeated measures|||"Eosinophil Count Over 16 Weeks~Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures."|
1676906|NCT01287039|3085209|Superiority or Other||Mean Difference (Final Values)|-0.276|Standard Error of the Mean|0.1632||0.0919|2-Sided|95.0|-0.597|0.045|||Mixed model repeated measures|||Inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, OCS use at enrollment as fixed factors, and covariate for baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.|
1676907|NCT01287039|3085210|Superiority or Other||Median Difference (Final Values)|0.058|Standard Error of the Mean|0.0125|<|0.0001|2-Sided|95.0|0.034|0.083|||Mixed model repeated measures|||For each week, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment as fixed factor, and covariate baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.|
1676908|NCT01287039|3085211|Superiority or Other||Cox Proportional Hazard|0.575|||<|0.0001|2-Sided|95.0|0.44|0.75|||Regression, Cox|Stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).|Reslizumab vs placebo|Kaplan-Meier estimate of probability (5) of not experiencing a CAE by week 52. The first CAEs for each patient occurring after randomization and up to 2 weeks after the end of treatment period were analyzed. Patients without a CAE within this time frame were censored at two weeks after the treatment completion date or study discontinuation, whichever came first.|
1676909|NCT01287039|3085212|Superiority or Other||Mean Difference (Final Values)|-0.266|Standard Error of the Mean|0.0681||0.0001|2-Sided|95.0|-0.399|-0.132|||Mixed model repeated measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.|
1676910|NCT01287039|3085213|Superiority or Other||Mean Difference (Final Values)|0.238|Standard Error of the Mean|0.0967||0.0143|2-Sided|95.0|0.048|0.428|||Mixed model repeated measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.|
1676911|NCT01287039|3085214|Superiority or Other||Mean Difference (Net)|0.137|Standard Error of the Mean|0.0311|<|0.0001|2-Sided|95.0|0.076|0.198|||Mixed Model Repeated Measures|||For each week and overall change, inferential statistics were from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, region, oral glucocorticosteroids use at enrollment and sex as fixed factors, and covariates for height and baseline value and patient as a random effect. Unstructured covariance structure was assumed for the repeated measures.|
1676912|NCT01287039|3085215|Superiority or Other||CAE rate ratio (reslizumab vs placebo)|0.501|||<|0.0001|2-Sided|95.0|0.3726|0.6737||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.|
1676913|NCT01287013|3085216|Superiority or Other||||||=|0|||||||t-test, 2 sided||||
1676914|NCT01287013|3085217|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1676915|NCT01287013|3085218|Other||||||<|0.04|||||||t-test, 2 sided||||
1676916|NCT01287013|3085219|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1676917|NCT01287013|3085220|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1676918|NCT01286558|3085309|Superiority or Other||Mean Difference (Final Values)|-1.64||||||95.0|-4.27|0.99|||||||
1676919|NCT01286558|3085310|Superiority or Other||Mean Difference (Final Values)|-0.89||||||95.0|-2.57|0.79|||||||
1676920|NCT01286558|3085311|Superiority or Other||Mean Difference (Final Values)|-1.9||||||95.0|-4.16|0.35|||||||
1676921|NCT01286558|3085312|Superiority or Other||Mean Difference (Final Values)|-1.21||||||95.0|-2.58|0.15|||||||
1676922|NCT01286558|3085313|Superiority or Other||Mean Difference (Final Values)|2.14||||||95.0|-0.36|4.64|||||||
1676923|NCT01286558|3085314|Superiority or Other||Mean Difference (Final Values)|1.46||||||95.0|-0.22|3.14|||||||
1676924|NCT01286454|3085320|Superiority or Other||Ratio of Adjusted Means|171.06|||||2-Sided|90.0|115.82|187.78||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.|
1676925|NCT01286454|3085320|Superiority or Other||Ratio of Adjusted Means|14.38|||||2-Sided|90.0|12.83|16.11||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.|
1676926|NCT01286454|3085320|Superiority or Other||Ratio of Adjusted Means|48.58|||||2-Sided|90.0|43.35|54.44||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.|
1676927|NCT01286454|3085320|Superiority or Other||Ratio of Adjusted Means|134.83|||||2-Sided|90.0|120.31|151.09||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.|
1676928|NCT01286454|3085320|Superiority or Other||Ratio of Adjusted Means|259.4|||||2-Sided|90.0|231.48|290.7||||||Natural log transformed Cmax of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.|
1676929|NCT01286454|3085321|Superiority or Other||Ratio of Adjusted Means|114.7|||||2-Sided|90.0|106.99|122.97||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.|
1676930|NCT01286454|3085321|Superiority or Other||Ratio of Adjusted Means|28.34|||||2-Sided|90.0|26.09|30.78||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 20% ER-BIC Fasted was test.|
1676931|NCT01286454|3085321|Superiority or Other||Ratio of Adjusted Means|66.87|||||2-Sided|90.0|61.56|72.63||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.|
1676957|NCT01286168|3085360|Superiority or Other|||||||0.03|||||||McNemar|||Antisepsis and Control sides were compared.|
1676958|NCT01286168|3085361|Superiority or Other|||||||0.02|||||||McNemar|||Antisepsis and Control sides were compared.|
1676932|NCT01286454|3085321|Superiority or Other||Ratio of Adjusted Means|103.71|||||2-Sided|90.0|95.48|112.65||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.|
1676933|NCT01286454|3085321|Superiority or Other||Ratio of Adjusted Means|112.8|||||2-Sided|90.0|103.85|122.52||||||Natural log transformed AUClast of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.|
1676934|NCT01286454|3085322|Superiority or Other||Ratio of Adjusted Means|113.55|||||2-Sided|90.0|105.91|121.74||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg 10% ER-BIC Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fed was test.|
1676935|NCT01286454|3085322|Superiority or Other||Ratio of Adjusted Means|70.36|||||2-Sided|90.0|64.52|76.74||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 15% ER-BIC Fasted was test.|
1676936|NCT01286454|3085322|Superiority or Other||Ratio of Adjusted Means|103.07|||||2-Sided|90.0|95.16|111.64||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg 10% ER-BIC Fasted was test.|
1676937|NCT01286454|3085322|Superiority or Other||Ratio of Adjusted Means|111.23|||||2-Sided|90.0|102.69|120.47||||||Natural log transformed AUC (0 - ∞) of 5-HMT was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Fesoterodine 4 mg ER Tablet Fasted was reference and Fesoterodine 4 mg IR-BIC Fasted was test.|
1676938|NCT01286324|3085334|Superiority|||||||0.11||||||P value is adjusted based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided||||
1676939|NCT01286324|3085335|Superiority|||||||0.45||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||P-value for Trait Subscale|
1676940|NCT01286324|3085335|Superiority|||||||0.47||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided|||Statistical Analysis for State Subscale|
1676941|NCT01286324|3085336|Superiority|||||||0.6||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided||||
1676942|NCT01286324|3085337|Superiority|||||||0.21||||||Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure|t-test, 2 sided||||
1676943|NCT01286311|3085338|Superiority or Other||Odds Ratio (OR)|2.18||||0.3|2-Sided|95.0|0.5|9.5|||Generalized Logistic Regression||||
1676944|NCT01286311|3085339|Superiority or Other||Odds Ratio (OR)|2.72||||0.13|2-Sided|95.0|0.73|10.1|||Generalized Logistic Regression||||
1676945|NCT01286311|3085340|Superiority or Other||Odds Ratio (OR)|2.13||||0.038|2-Sided|95.0|1.05|4.32|||Generalized Logistic Regression||||
1676946|NCT01286311|3085341|Superiority or Other||Odds Ratio (OR)|1.25||||0.27|2-Sided|95.0|0.84|1.85|||Generalized Logistic Regression||||
1676947|NCT01286311|3085342|Superiority or Other||Odds Ratio (OR)|1.0||||0.99|2-Sided|95.0|0.54|1.86|||Generalized Logistic Regression||||
1676948|NCT01286272|3085347|Superiority||Hazard Ratio (HR)|0.94||||0.8457|2-Sided|95.0|0.51|1.74|||Log Rank||||
1676949|NCT01286168|3085354|Superiority or Other|||||||0.003|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.|
1676950|NCT01286168|3085354|Superiority or Other|||||||0.003|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.|
1676951|NCT01286168|3085355|Superiority or Other|||||||0.004|||||||Likelihood-ratio test|||Antisepsis and Control sides were compared. Due to zero events in the antisepsis side for this endpoint, p-value was derived from likelihood-ratio test comparing the intercept only model to the model with intercept and treatment side included.|
1676952|NCT01286168|3085356|Superiority or Other|||||||0.02|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. P-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient. P-value was adjusted for side- and drain-specific variables: indication (cancer or prophylaxis), operation (mastectomy only, mastectomy+SLNB, mastectomy +ALND), and drain duration.|
1676953|NCT01286168|3085356|Superiority or Other|||||||0.02|||||||Mixed Models Analysis|||Antisepsis and Control sides were compared. Unadjusted p-value from generalized linear mixed effect model accounting for correlation among multiple drains from the same patient.|
1676954|NCT01286168|3085357|Superiority or Other|||||||0.45|||||||McNemar|||Antisepsis and Control sides were compared.|
1676965|NCT01285609|3085407|Superiority or Other (legacy)||Hazard Ratio (HR)|0.869||||0.0678|2-Sided|95.0|0.749|1.009|||Log Rank|p-value based on an unstratified 2-sided log rank test|Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin|
1676966|NCT01285609|3085408|Superiority or Other (legacy)||Hazard Ratio (HR)|0.917||||0.2421|2-Sided|95.0|0.792|1.061||p-value based on stratified 2-sided log-rank test|Log Rank||Hazard of Ipilimumab over Placebo with 2-sided 95% confidence intervals based on a stratified Cox proportional hazards model with several stratification factors and treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin|
1676967|NCT01285609|3085409|Superiority or Other (legacy)||Hazard Ratio (HR)|0.907||||0.2517|2-Sided|95.0|0.767|1.072|||Log Rank|p-value based on an unstratified 2-sided log rank test|Hazard of Ipilimumab over Hazard of Placebo with 2-sided 95% confidence intervals are based on an unstratified Cox proportional hazards model with treatment as the single covariate|Hazard ratio = Ipilimumab with Paclitaxel/Carboplatin over Placebo with Paclitaxel/Carboplatin|
1676968|NCT01285323|3085482|Superiority or Other||CAE rate ratio|0.6686||||0.402|2-Sided|95.0|0.2878|1.6479||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Hospitalization or ER visit The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.|
1676969|NCT01285323|3085482|Superiority or Other||CAE rate ratio (reslizumab vs placebo)|0.3893|||<|0.0001|2-Sided|95.0|0.2621|0.5782||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||CAE Due to Requiring Systemic Corticosteroids The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.|
1676970|NCT01285323|3085485|Superiority or Other||Mean Difference (Final Values)|-0.062|Standard Error of the Mean|0.1775||0.7263|2-Sided|95.0|-0.411|0.287||Statistical significance at <=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p>0.05, no further comparisons were interpreted inferentially.|
1676971|NCT01285323|3085486|Superiority or Other||Mean Difference (Final Values)|0.035|Standard Error of the Mean|0.012||0.0037|2-Sided|95.0|0.011|0.059||Statistical significance at <=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p>0.05, no further comparisons were interpreted inferentially.|
1676972|NCT01285323|3085487|Superiority or Other||Hazard Ratio (HR)|0.486|||<|0.0001|2-Sided|95.0|0.353|0.67|||Regression, Cox|Stratified by baseline usage of oral corticosteroid (yes or no) and geographical region (US or other).|Reslizumab vs placebo|Kaplan-Meier estimate of probability (5) of not experiencing a CAE by week 52. The first CAEs for each patient occurring after randomization and up to 2 weeks after the end of treatment period were analyzed. Patients without a CAE within this time frame were censored at two weeks after the treatment completion date or study discontinuation, whichever came first.|
1676973|NCT01285323|3085488|Superiority or Other||Mean Difference (Final Values)|-0.196|Standard Error of the Mean|0.0664||0.0032|2-Sided|95.0|-0.327|-0.066||Statistical significance at <=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p>0.05, no further comparisons were interpreted inferentially.|
1676974|NCT01285323|3085489|Superiority or Other||Mean Difference (Final Values)|0.209|Standard Error of the Mean|0.937||0.0259|2-Sided|95.0|0.025|0.393||Statistical significance at <=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p>0.05, no further comparisons were interpreted inferentially.|
1676975|NCT01285323|3085490|Superiority or Other||Mean Difference (Final Values)|0.093|Standard Error of the Mean|0.0317||0.0037|2-Sided|95.0|0.03|0.155||Statistical significance at <=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active-placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p>0.05, no further comparisons were interpreted inferentially.|
1676976|NCT01285323|3085491|Superiority or Other||Mean Difference (Final Values)|0.101|Standard Error of the Mean|0.0397||0.0109|2-Sided|95.0|0.023|0.179||Statistical significance at <=0.05.|Mixed model repeated measures (MMRM)|Fixed Factors: treatment, visit, trt by visit interaction, region, OCS at enrollment, sex. Random: covariates for height, baseline value and patient|active - placebo|A pre-specified fixed sequence multiple testing procedure was implemented to test the secondary endpoints while controlling the overall Type I error rate at 0.05. At the point where p>0.05, no further comparisons were interpreted inferentially.|
1677011|NCT01285310|3085542|Superiority or Other (legacy)||Risk Difference (RD)|-1.4|||||2-Sided||||||||||
1677012|NCT01285310|3085543|Superiority or Other (legacy)||Risk Difference (RD)|9.5|||||||||||||||
1676977|NCT01285323|3085492|Superiority or Other||CAE rate ratio (reslizumab vs placebo)|0.4063|||<|0.0001|2-Sided|95.0|0.2819|0.5855||The treatment effect was tested using the likelihood based Chi-square test at the 0.05 significance level.|Chi-squared|||The frequency of CAEs was analyzed using the generalized linear model (GLM) for data from the negative binomial distributions that is commonly referred to as the negative binomial (NB) regression model. The primary NB model included the treatment group and randomization stratification factors as model factors and the logarithm of follow up time excluding the summed duration of exacerbations in the treatment period as an offset variable.|
1676978|NCT01285310|3085526|Superiority or Other (legacy)||Risk Difference (RD)|-5.0|||||||||||||||
1676979|NCT01285310|3085526|Superiority or Other (legacy)||Risk Difference (RD)|-11.2|||||||||||||||
1676980|NCT01285310|3085527|Superiority or Other (legacy)||Risk Difference (RD)|-0.3|||||||||||||||
1676981|NCT01285310|3085527|Superiority or Other (legacy)||Risk Difference (RD)|-11.9|||||||||||||||
1676982|NCT01285310|3085528|Superiority or Other (legacy)||Risk Difference (RD)|12.6|||||||||||||||
1676983|NCT01285310|3085528|Superiority or Other (legacy)||Risk Difference (RD)|5.4|||||||||||||||
1676984|NCT01285310|3085529|Superiority or Other (legacy)||LS Mean Difference|1.7|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate||
1676985|NCT01285310|3085529|Superiority or Other (legacy)||LS Mean Difference|-1.2|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate||
1676986|NCT01285310|3085530|Superiority or Other (legacy)||Difference in LS Means|-6.54|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1676987|NCT01285310|3085530|Superiority or Other (legacy)||Difference in LS Means|12.05|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1676988|NCT01285310|3085531|Superiority or Other (legacy)||Difference in LS Means|67.09|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1676989|NCT01285310|3085531|Superiority or Other (legacy)||Difference in LS Means|8.29|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1676990|NCT01285310|3085532|Superiority or Other (legacy)||Difference in LS Means|-5.72|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1676991|NCT01285310|3085532|Superiority or Other (legacy)||Difference in LS Means|1.57|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1676992|NCT01285310|3085533|Superiority or Other (legacy)||Difference in LS Means|-1.8|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1676993|NCT01285310|3085533|Superiority or Other (legacy)||Difference in LS Means|5.85|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1676994|NCT01285310|3085534|Superiority or Other (legacy)||Difference in LS Means|-12.5|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1676995|NCT01285310|3085534|Superiority or Other (legacy)||Difference in LS Means|-14.34|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1676996|NCT01285310|3085535|Superiority or Other (legacy)||Difference in LS Means|-37.82|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate||
1676997|NCT01285310|3085535|Superiority or Other (legacy)||LS Mean Difference|-34.82|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate||
1676998|NCT01285310|3085536|Superiority or Other (legacy)||Difference in LS Means|-7.02|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate||
1676999|NCT01285310|3085536|Superiority or Other (legacy)||LS Mean Difference|1.86|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate||
1677000|NCT01285310|3085537|Superiority or Other (legacy)||LS Mean Difference|3.01|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24; treatment group as a factor and the baseline value as a covariate.||
1677001|NCT01285310|3085537|Superiority or Other (legacy)||LS Mean Difference|4.6|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, with treatment group as a factor and the baseline value as a covariate.||
1677002|NCT01285310|3085538|Superiority or Other (legacy)||LS Mean Difference|-0.09|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.||
1677003|NCT01285310|3085538|Superiority or Other (legacy)||LS Mean Difference|0.03|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.||
1677004|NCT01285310|3085539|Superiority or Other (legacy)||Difference in proportions|4.6|||||||||||||||
1677005|NCT01285310|3085539|Superiority or Other (legacy)||Difference in proportions|-4.3|||||||||||||||
1677006|NCT01285310|3085540|Superiority or Other (legacy)||Least Square Mean Difference|-1.24|||||||||||||||
1677007|NCT01285310|3085540|Superiority or Other (legacy)||LS Mean Difference|0.94|||||||||||||||
1677008|NCT01285310|3085541|Superiority or Other (legacy)||LS Mean Difference|1.98|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24 with treatment group as a factor and the baseline value as a covariate.||
1677013|NCT01285310|3085543|Superiority or Other (legacy)||Risk Difference (RD)|-1.5|||||||||||||||
1677023|NCT01285310|3085548|Superiority or Other (legacy)||Risk Difference (RD)|-3.9|||||||||||||||
1677024|NCT01285310|3085549|Superiority or Other (legacy)||Least Square Mean Difference|-0.1|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1677025|NCT01285310|3085549|Superiority or Other (legacy)||LS Mean Difference|-1.2|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677026|NCT01285310|3085550|Superiority or Other (legacy)||Difference in LS Means|-16.19|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677027|NCT01285310|3085550|Superiority or Other (legacy)||Difference in LS Means|7.18|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677028|NCT01285310|3085551|Superiority or Other (legacy)||Difference in LS Means|58.05|||||||||||||||
1677029|NCT01285310|3085551|Superiority or Other (legacy)||Difference in LS Means|4.7|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677030|NCT01285310|3085552|Superiority or Other (legacy)||Difference in LS Means|-0.77|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1677031|NCT01285310|3085552|Superiority or Other (legacy)||Difference in LS Means|5.93|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677032|NCT01285310|3085553|Superiority or Other (legacy)||Difference in LS Means|-3.84|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677033|NCT01285310|3085553|Superiority or Other (legacy)||Difference in LS Means|0.59|||||2-Sided||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677034|NCT01285310|3085554|Superiority or Other (legacy)||Difference in LS Means|0.34|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677035|NCT01285310|3085554|Superiority or Other (legacy)||Difference in LS Means|-14.35|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677036|NCT01285310|3085555|Superiority or Other (legacy)||Difference in LS Means|-38.37|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677037|NCT01285310|3085555|Superiority or Other (legacy)||Difference in LS Means|-35.54|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677038|NCT01285310|3085556|Superiority or Other (legacy)||LS Mean Difference|-3.26|||||||||||||||
1677039|NCT01285310|3085556|Superiority or Other (legacy)||LS Mean Difference|2.58|||||2-Sided||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677040|NCT01285310|3085557|Superiority or Other (legacy)||LS Mean Difference|-0.61|||||||||||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1677041|NCT01285310|3085557|Superiority or Other (legacy)||LS Mean Difference|6.15|||||||||||||Based on an analysis of covariance model (Ancova) for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate||
1677042|NCT01285310|3085558|Superiority or Other (legacy)||Least Square Mean Difference|-0.02|||||2-Sided||||||||||
1677043|NCT01285310|3085558|Superiority or Other (legacy)||LS Mean Difference|0.14|||||||||||||||
1677044|NCT01285310|3085559|Superiority or Other (legacy)||Risk Difference (RD)|-7.2|||||||||||||||
1677045|NCT01285310|3085559|Superiority or Other (legacy)||Risk Difference (RD)|-5.5|||||||||||||||
1677046|NCT01285310|3085560|Superiority or Other (legacy)||LS Mean Difference|-0.7|||||||||||||||
1677047|NCT01285310|3085560|Superiority or Other (legacy)||LS Mean Difference|1.21|||||||||||||||
1677048|NCT01285310|3085561|Superiority or Other (legacy)||LS Mean Difference|1.77|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate.||
1677049|NCT01285310|3085561|Superiority or Other (legacy)||LS Mean Difference|-0.17|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16; treatment group as a factor and the baseline value as a covariate||
1677050|NCT01285310|3085562|Superiority or Other (legacy)||Least Squares Mean Difference|-0.15|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 24, treatment group as a factor and the baseline value as a covariate.||
1677051|NCT01285310|3085562|Superiority or Other (legacy)||LS Mean Difference|-0.007|||||||||||||||
1677052|NCT01285310|3085563|Superiority or Other (legacy)||Risk Difference (RD)|3.6|||||||||||||||
1677053|NCT01285310|3085563|Superiority or Other (legacy)||Risk Difference (RD)|-4.5|||||||||||||||
1677054|NCT01285310|3085564|Superiority or Other (legacy)||LS Mean Difference|-0.091|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677055|NCT01285310|3085564|Superiority or Other (legacy)||LS Mean Difference|-0.004|||||||||||||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor and the baseline value as a covariate.||
1677056|NCT01285310|3085565|Superiority or Other (legacy)||Risk Difference (RD)|-1.2||||0.8721|2-Sided|95.0|-16.2|13.8|||Chi-squared||2-sided 95% CI is based on a normal approximation to the binomial distribution||
1677077|NCT01284062|3085644|Superiority or Other||LS mean difference|-0.97||||0.3639|2-Sided|80.0|-2.335|0.403|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.|
1677078|NCT01284062|3085644|Superiority or Other||LS mean|-0.79|||||2-Sided|80.0|-1.761|0.19|||||||
1677057|NCT01285310|3085565|Superiority or Other (legacy)||Risk Difference (RD)|-7.4||||0.3134|2-Sided|95.0|-27.1|7.0|||Chi-squared||2-sided 95% CI of the proportion difference is based on a normal approximation to the binomial distribution|Significance testing was done using the following closed procedure; if the overall test among treatments is statistically significant at the 0.05 level, pair-wise comparisons (30 mg versus PBO, and 20 mg versus PBO, using a 0.05 two-sided significance level) will be performed|
1677058|NCT01284634|3085591|Superiority or Other||Mean Difference (Final Values)|-6.54|Standard Error of the Mean|6.158||0.302|2-Sided|90.0|-17.22|4.14|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.|
1677059|NCT01284634|3085591|Superiority or Other||Mean Difference (Final Values)|-9.35|Standard Error of the Mean|5.943||0.133|2-Sided|90.0|-19.66|0.95|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.|
1677060|NCT01284634|3085591|Superiority or Other||Mean Difference (Final Values)|-6.89|Standard Error of the Mean|5.454||0.222|2-Sided|90.0|-16.35|2.56|||Regression, Linear|||The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.|
1677061|NCT01284621|3085601|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone.|Geometric mean ratio|98.29|Standard Deviation|11.3|||2-Sided|90.0|92.67|104.25|||||Standard deviation is actually the gCV||
1677062|NCT01284621|3085602|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone|Geometric mean ratio|98.67|Standard Deviation|5.2|||2-Sided|90.0|96.0|101.42|||||Standard deviation is actually the gCV||
1677063|NCT01284621|3085603|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone.|Geometric mean ratio|103.61|Standard Deviation|28.0|||2-Sided|90.0|89.73|119.64|||||Standard deviation is actually the gCV||
1677064|NCT01284621|3085604|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by ramipril alone|Geometric mean ratio|108.14|Standard Deviation|14.0|||2-Sided|90.0|100.51|116.35|||||Standard deviation is actually the gCV||
1677065|NCT01284621|3085605|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by empa alone|Geometric mean ratio|104.47|Standard Deviation|13.1|||2-Sided|90.0|97.65|111.77|||||Standard deviation is actually the gCV||
1677066|NCT01284621|3085606|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability. Ratio calculated as empa plus ramipril divided by empa alone|Geometric mean ratio|96.55|Standard Deviation|7.1|||2-Sided|90.0|93.05|100.18|||||Standard deviation is actually the geometric coefficient of variation (gCV)||
1677067|NCT01284517|3085607|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|1.0||0.992|||||||ANCOVA||||
1677068|NCT01284517|3085608|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.141||0.095|||||||Mixed Models Analysis||||
1677069|NCT01284517|3085609|Superiority or Other||Mean Difference (Final Values)|-1.5|Standard Error of the Mean|1.08||0.176|||||||Mixed Models Analysis|||Null hypothesis (H0) assumes equal values between analysis groups in mean change from baseline in MADRS score, alternative hypothesis (HA) assumes unequal values between groups. Sample size determined by two-sample t-test. A mean difference of 3.25 units in change in MADRS score for the Lurasdone 20-120 mg arm over placebo with common standard deviation of 9 units was used. N=162 subjects per arm (total N=324) yields power of 90%. A 5% adjustment for drop-outs gives N=340, or N=170 per arm.|
1677070|NCT01284361|3085616|Superiority or Other||Proportion|91.5|||||2-Sided|95.0|84.5|97.5|||||Seventy five of the 82 subjects (91.5%) preferred the longer commercially available catheter over the experimental 30 cm catheter.|The sample size of 81 subjects provides a 10.8% margin of error.|
1677071|NCT01284140|3085626|Superiority||Mean Difference (Final Values)|0.03||||0.03|2-Sided||||||t-test, 2 sided|||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. This resulted in 4 separate best-fit curves. The model parameter of amplitude was derived from the best-fit curves.|
1677072|NCT01284140|3085627|Superiority|||||||0.55|||||||Fisher Exact||||
1677073|NCT01284140|3085628|Other|||||||0.0074|||||||Extra sum-of-squares F test|This result suggests that the best-fit values for amplitude and phase are different between Day 1 and Day 3 in the Sleep Promotion group.||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. Model parameters of acrophase and amplitude and their standard errors were derived from these curves. Using the extra sum-of-squares F test, the null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was tested for the Sleep promotion group.|
1677074|NCT01284140|3085628|Other|||||||0.37|||||||Extra sum-of-squares F test|The null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was not rejected for the Usual Care group.||Nonlinear regression using the least-squares approach was used to fit a single 24-hour cosine curve to all normalized data in each group on each day of 24-hour urine collection. Model parameters of acrophase and amplitude and their standard errors were derived from these curves. Using the extra sum-of-squares F test, the null hypothesis that model parameters of amplitude and phase were the same on Day 1 and Day 3 was tested for the Usual Care group.|
1677075|NCT01284062|3085644|Superiority or Other||LS mean difference|0.53||||0.6285|2-Sided|80.0|-0.884|1.945|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.|
1677076|NCT01284062|3085644|Superiority or Other||LS mean difference|-0.98||||0.3446|2-Sided|80.0|-2.32|0.355|||ANCOVA|||P-value was analyzed from ANCOVA model with terms for treatment group and baseline.|
1677079|NCT01284062|3085644|Superiority or Other||LS mean|-2.3|||||2-Sided|80.0|-3.178|-1.419|||||||
1677080|NCT01284062|3085644|Superiority or Other||LS mean|-2.28|||||2-Sided|80.0|-3.19|-1.374|||||||
1677081|NCT01284062|3085644|Superiority or Other||LS mean|-1.32|||||2-Sided|80.0|-2.332|-0.3|||||||
1677082|NCT01284062|3085645|Superiority or Other||percent difference|-16.67||||0.22|2-Sided|80.0|-34.22|-1.95|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher’s exact test.|
1677083|NCT01284062|3085645|Superiority or Other||percent difference|2.08||||1|2-Sided|80.0|-17.8|19.99|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher’s exact test.|
1677084|NCT01284062|3085645|Superiority or Other||percent difference|16.67||||0.4082|2-Sided|80.0|-5.33|35.76|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher’s exact test.|
1677085|NCT01284062|3085645|Superiority or Other||percentage of participants|0.0|||||2-Sided|80.0|0.0|11.22|||||CI was assessed by Wilson score method.||
1677086|NCT01284062|3085645|Superiority or Other||percentage of participants|18.75|||||2-Sided|80.0|9.4|33.92|||||CI was assessed by Wilson score method.||
1677087|NCT01284062|3085645|Superiority or Other||percentage of participants|33.33|||||2-Sided|80.0|20.08|49.88|||||CI was assessed by Wilson score method.||
1677088|NCT01284062|3085645|Superiority or Other||percentage of participants|16.67|||||2-Sided|80.0|7.14|34.22|||||CI was assessed by Wilson score method.||
1677089|NCT01284062|3085646|Superiority or Other||percent difference|-26.28||||0.2016|2-Sided|80.0|-46.45|-3.15|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher’s exact test.|
1677090|NCT01284062|3085646|Superiority or Other||percent difference|8.33||||0.7177|2-Sided|80.0|-15.37|30.54|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher’s exact test.|
1677091|NCT01284062|3085646|Superiority or Other||percent difference|18.33||||0.4495|2-Sided|80.0|-6.13|39.98|||Fisher Exact||CI was assessed by Wilson score method.|Two-sided p-value was calculated by Fisher’s exact test.|
1677092|NCT01284062|3085646|Superiority or Other||percentage of participants|15.38|||||2-Sided|80.0|6.58|31.96|||||CI was assessed by Wilson score method.||
1677093|NCT01284062|3085646|Superiority or Other||percentage of participants|50.0|||||2-Sided|80.0|34.74|65.26|||||CI was assessed by Wilson score method.||
1677094|NCT01284062|3085646|Superiority or Other||percentage of participants|60.0|||||2-Sided|80.0|43.59|74.43|||||CI was assessed by Wilson score method.||
1677095|NCT01284062|3085646|Superiority or Other||percentage of participants|41.67|||||2-Sided|80.0|25.53|59.81|||||CI was assessed by Wilson score method.||
1677096|NCT01284062|3085651|Superiority or Other||LS mean ratio|1.04||||0.9372|2-Sided|80.0|0.51|2.141|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677097|NCT01284062|3085651|Superiority or Other||LS mean ratio|1.5||||0.4434|2-Sided|80.0|0.758|2.97|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677098|NCT01284062|3085651|Superiority or Other||LS mean ratio|0.3||||0.0283|2-Sided|80.0|0.15|0.598|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 12: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677099|NCT01284062|3085651|Superiority or Other||LS mean ratio|0.66||||0.4409|2-Sided|80.0|0.335|1.316|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677100|NCT01284062|3085651|Superiority or Other||LS mean ratio|1.47||||0.4633|2-Sided|80.0|0.748|2.882|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677101|NCT01284062|3085651|Superiority or Other||LS mean ratio|0.46||||0.1553|2-Sided|80.0|0.233|0.926|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 8: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677102|NCT01284062|3085651|Superiority or Other||LS mean ratio|0.6||||0.1996|2-Sided|80.0|0.361|1.0|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677103|NCT01284062|3085651|Superiority or Other||LS mean ratio|1.01||||0.9856|2-Sided|80.0|0.617|1.644|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677104|NCT01284062|3085651|Superiority or Other||LS mean ratio|0.51||||0.0885|2-Sided|80.0|0.313|0.846|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 4: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677105|NCT01284062|3085651|Superiority or Other||LS mean ratio|1.11||||0.8277|2-Sided|80.0|0.609|2.008|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677106|NCT01284062|3085651|Superiority or Other||LS mean ratio|1.01||||0.9754|2-Sided|80.0|0.586|1.753|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677107|NCT01284062|3085651|Superiority or Other||LS mean ratio|1.16||||0.7352|2-Sided|80.0|0.663|2.021|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|Week 2: P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677108|NCT01284062|3085651|Superiority or Other||LS mean|0.67|||||2-Sided|80.0|0.411|1.076||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677109|NCT01284062|3085651|Superiority or Other||LS mean|0.96|||||2-Sided|80.0|0.623|1.465||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677110|NCT01284062|3085651|Superiority or Other||LS mean|0.19|||||2-Sided|80.0|0.122|0.297||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677111|NCT01284062|3085651|Superiority or Other||LS mean|0.64|||||2-Sided|80.0|0.374|1.084||||||Week 12: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677112|NCT01284062|3085651|Superiority or Other||LS mean|0.52|||||2-Sided|80.0|0.338|0.788||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677113|NCT01284062|3085651|Superiority or Other||LS mean|1.14|||||2-Sided|80.0|0.757|1.722||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677114|NCT01284062|3085651|Superiority or Other||LS mean|0.36|||||2-Sided|80.0|0.236|0.553||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677115|NCT01284062|3085651|Superiority or Other||LS mean|0.78|||||2-Sided|80.0|0.454|1.331||||||Week 8: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677116|NCT01284062|3085651|Superiority or Other||LS mean|0.55|||||2-Sided|80.0|0.388|0.779||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677117|NCT01284062|3085651|Superiority or Other||LS mean|0.92|||||2-Sided|80.0|0.669|1.269||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677118|NCT01284062|3085651|Superiority or Other||LS mean|0.47|||||2-Sided|80.0|0.339|0.655||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677119|NCT01284062|3085651|Superiority or Other||LS mean|0.92|||||2-Sided|80.0|0.631|1.328||||||Week 4: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677120|NCT01284062|3085651|Superiority or Other||LS mean|0.77|||||2-Sided|80.0|0.5|1.195||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677121|NCT01284062|3085651|Superiority or Other||LS mean|0.71|||||2-Sided|80.0|0.488|1.027||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677122|NCT01284062|3085651|Superiority or Other||LS mean|0.81|||||2-Sided|80.0|0.552|1.185||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677123|NCT01284062|3085651|Superiority or Other||LS mean|0.7|||||2-Sided|80.0|0.466|1.048||||||Week 2: LS mean and CI were based on back log-transformation of those from the ANCOVA model.|
1677124|NCT01284062|3085658|Superiority or Other||LS mean ratio|3.0||||0.0666|2-Sided|80.0|1.403|6.409|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677125|NCT01284062|3085658|Superiority or Other||LS mean ratio|1.9||||0.27|2-Sided|80.0|0.9|4.013|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677126|NCT01284062|3085658|Superiority or Other||LS mean ratio|0.7||||0.532|2-Sided|80.0|0.329|1.472|||ANCOVA||LS mean ratio and CI were based on back log-transformation of those from the ANCOVA model.|P-value was calculated from ANCOVA model with terms for treatment group, baseline (in log scale).|
1677127|NCT01284062|3085658|Superiority or Other||LS mean|1.24|||||2-Sided|80.0|0.794|1.949|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.||
1677128|NCT01284062|3085658|Superiority or Other||LS mean|0.79|||||2-Sided|80.0|0.517|1.203|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.||
1677129|NCT01284062|3085658|Superiority or Other||LS mean|0.29|||||2-Sided|80.0|0.187|0.446|||||LS mean and CI were based on back log-transformation of those from the ANCOVA model.||
1677130|NCT01284062|3085658|Superiority or Other||Least squares (LS) mean|0.41|||||2-Sided|80.0|0.225|0.766|||||LS mean and confidence interval (CI) were based on back log-transformation of those from the analysis of covariance (ANCOVA) model.||
1677131|NCT01283555|3085689|Superiority or Other|||||||0.487||||||The p-value presented here represents a comparison of the total number of non-iatrogenic findings at baseline and after one week of product use.|Fisher Exact|||Fishers exact test was used to compare the frequency of non-iatrogenic colposcopic findings at baseline and follow-up visits (after one week of twice-daily product use).|
1677132|NCT01283139|3085777|Superiority or Other||Odds Ratio (OR)|1.25||||0.453|2-Sided|90.0|0.76|2.05|||Regression, Logistic||||
1677133|NCT01283139|3085777|Superiority or Other||Odds Ratio (OR)|1.69||||0.077|2-Sided|90.0|1.04|2.74|||Regression, Logistic||||
1677134|NCT01283139|3085777|Superiority or Other||Odds Ratio (OR)|1.39||||0.27|2-Sided|90.0|0.85|2.25|||Regression, Logistic||||
1677135|NCT01283139|3085778|Superiority or Other||Odds Ratio (OR)|3.03||||0.049|2-Sided|90.0|1.2|7.68|||Regression, Logistic||||
1677136|NCT01283139|3085778|Superiority or Other||Odds Ratio (OR)|1.4||||0.498|2-Sided|90.0|0.62|3.19|||Regression, Logistic||||
1677137|NCT01283139|3085778|Superiority or Other||Odds Ratio (OR)|2.92||||0.044|2-Sided|90.0|1.22|7.01|||Regression, Logistic||||
1677138|NCT01283139|3085779|Superiority or Other||Odds Ratio (OR)|0.9||||0.884|2-Sided|90.0|0.27|3.02|||Regression, Logistic||||
1677139|NCT01283139|3085779|Superiority or Other||Odds Ratio (OR)|1.45||||0.598|2-Sided|90.0|0.45|4.66|||Regression, Logistic||||
1677140|NCT01283139|3085779|Superiority or Other||Odds Ratio (OR)|1.19||||0.808|2-Sided|90.0|0.37|3.81|||Regression, Logistic||||
1677141|NCT01283139|3085780|Superiority or Other||Odds Ratio (OR)|1.91||||0.038|2-Sided|90.0|1.14|3.19|||Regression, Logistic||||
1677142|NCT01283139|3085780|Superiority or Other||Odds Ratio (OR)|1.41||||0.264|2-Sided|90.0|0.85|2.35|||Regression, Logistic||||
1677143|NCT01283139|3085780|Superiority or Other||Odds Ratio (OR)|1.88||||0.042|2-Sided|90.0|1.13|3.14|||Regression, Logistic||||
1677144|NCT01283139|3085781|Superiority or Other||Odds Ratio (OR)|1.84||||0.031|2-Sided|90.0|1.16|2.94|||Regression, Logistic||||
1677145|NCT01283139|3085781|Superiority or Other||Odds Ratio (OR)|1.6||||0.094|2-Sided|90.0|1.01|2.54|||Regression, Logistic||||
1677146|NCT01283139|3085781|Superiority or Other||Odds Ratio (OR)|1.71||||0.057|2-Sided|90.0|1.03|2.71|||Regression, Logistic||||
1677147|NCT01282866|3085794|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1677167|NCT01280903|3086048|Superiority|||||||0.806||||||p=0.806 for Arthritis Self Efficacy Other Symptoms|Mixed Models Analysis||||
1677148|NCT01282814|3085795|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.46|||||2-Sided|90.0|101.45|111.71|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1677149|NCT01282814|3085796|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|109.97|||||2-Sided|90.0|103.68|116.63|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1677150|NCT01282814|3085797|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|115.85|||||2-Sided|90.0|108.45|123.72|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1677151|NCT01282723|3085804|Superiority or Other||Odds Ratio (OR)|0.85||||0.3204|2-Sided|95.0|0.61|1.17|||Mixed Models Analysis|||"Estimation of Odds Ratio of False Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the False Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly less than TOCO.~Alternative hypothesis: There is a difference between the False Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly less than SureCALL®."|
1677152|NCT01282723|3085804|Superiority or Other||Odds Ratio (OR)|1.47||||0.0093|2-Sided|95.0|1.1|1.95|||Mixed Models Analysis|||"Estimation of Odds Ratio of True Positive Fraction between SureCALL® and TOCO~Null hypothesis: There is no difference between the True Positive Fraction of SureCALL® and of TOCO or the SureCALL® is significantly greater than TOCO.~Alternative hypothesis: There is a difference between the True Positive Fraction of SureCALL® and of TOCO and the TOCO is significantly greater than SureCALL®."|
1677153|NCT01282710|3085805|Superiority or Other|||||||0.1676|||||||Mixed Models Analysis|||"Agreement between TOCO and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0."|
1677154|NCT01282710|3085805|Superiority or Other|||||||0.04627|||||||Mixed Models Analysis|||"Agreement between SureCALL® and IUPC Contraction Peak Events~Null hypothesis: the mean peak difference between TOCO and IUPC is equal to 0. Alternative hypothesis: the mean peak difference is not equal to 0."|
1677155|NCT01282424|3085838|Superiority||||||<|0.0001||||||The null hypothesis is ≤ 20%.|Exact binomial test||||
1677156|NCT01281969|3085921|Superiority or Other (legacy)|||||||0.4||||||p-value is not adjusted for multiple comparisons.|Chi-squared|X2 = 0.72, p=.40||Chi-squared test was used to compare distribution of responders by randomization group. Power calculation was based on CY-BOCS (primary outcome).|
1677157|NCT01281969|3085922|Superiority or Other (legacy)|||||||0.12||||||p-value is not adjusted.|Wilcoxon (Mann-Whitney)|Mean rank sum in the placebo group = 19.92; mean rank sum in the IVIG group = 15.97. Z = -1.18, p=.12||The Wilcoxon two-sample test was used to compare CGI-Improvement ratings (an ordinal variable) at week 6. Power calculation was based on CYBOCS as primary outcome.|
1677158|NCT01281969|3085923|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.97||||0.44|2-Sided|95.0|-7.1|3.15||p-value is unadjusted. a priori threshold for statistical significance is .05|ANCOVA|F(1,34)=0.62, p=.44||Analysis of covariance model controlling for baseline scores. A priori power calculations based on the Perlmutter et al. study (IVIG effect size 1.2) suggested that a sample size of 16 per group would be sufficient to detect an effect size of 1.0 with 80% power.|
1677159|NCT01281839|3085972|Superiority or Other||Difference in proportions of SVR4|41.0|||<|0.001|2-Sided|95.0|32.1|49.9|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.|
1677160|NCT01281839|3085973|Superiority or Other||Difference in proportions of SVR24|44.1|||<|0.001|2-Sided|95.0|34.9|53.2|||Cochran-Mantel-Haenszel|||There is no difference in proportions of SVR24 between the treatment groups.|
1677161|NCT01281839|3085974|Superiority or Other||Difference in proportions of SVR72|43.3|||<|0.001|2-Sided|95.0|34.1|52.5|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR72 between the treatment groups.|
1677162|NCT01281839|3085975|Superiority or Other||Difference in proportions of SVR12|43.8|||<|0.001|2-Sided|95.0|34.6|53.0|||Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in proportions of SVR12 between the treatment groups.|
1677163|NCT01281501|3085982|Superiority or Other||Mean Difference (Final Values)|-2.6|Standard Deviation|5.0||0.6|2-Sided|95.0|-12.7|7.4|||t-test, 2 sided|||Null hypothesis is that the treatment with pantoprazole arm is not different in immediate relief of acute, severe dyspeptic pain compared with conventional arm.|
1677164|NCT01281475|3085984|Superiority|We modeled each outcome variable as a function of treatment (ie, levodopa versus placebo), visit (ie, baseline vs. 12-month follow-up) and the treatment-by-visit interaction; the interaction term tests whether the effect of levodopa treatment over time is significantly greater than that of the placebo group.|||||<|0.05||||||After Bonferonni correction for multiple comparisons|Generalized estimating equations|||We performed generalized estimating equations with an unstructured covariance matrix to account for inter-correlations within measurements on the same participant over time.|
1677165|NCT01280903|3086047|Superiority|||||||0.12||||||p=0.120 for Perceived Therapeutic Efficacy of Exercise and Hypertension|t-test, 1 sided||||
1677166|NCT01280903|3086047|Superiority|||||||0.008||||||p=0.008 for Perceived Therapeutic Efficacy of Exercise and Arthritis|Mixed Models Analysis||||
1677228|NCT01280591|3086109|Superiority or Other|||||||0.0064|||||||ANCOVA||||
1677168|NCT01280903|3086048|Superiority|||||||0.34||||||p=0.340 for Arthritis Self Efficacy Function|Mixed Models Analysis||||
1677169|NCT01280903|3086048|Superiority|||||||0.219||||||p=0.219 for Arthritis Self Efficacy Pain|Mixed Models Analysis||||
1677170|NCT01280903|3086049|Superiority|||||||0.365||||||p=0.365 for Exercise Self-Efficacy|Mixed Models Analysis||||
1677171|NCT01280903|3086049|Superiority|||||||0.95||||||p=0.950 for Exercise Barriers Self-Efficacy|Mixed Models Analysis||||
1677172|NCT01280903|3086050|Superiority|||||||0.826||||||p=0.826 for Short Form-36v2 Physical Component|Mixed Models Analysis||||
1677173|NCT01280903|3086050|Superiority|||||||0.406||||||p=0.406 for Short Form-36v2 Mental Component|Mixed Models Analysis||||
1677174|NCT01280903|3086051|Superiority|||||||0.947|||||||Mixed Models Analysis||||
1677175|NCT01280903|3086052|Superiority|||||||0.993|||||||Mixed Models Analysis||||
1677176|NCT01280903|3086053|Superiority|||||||0.26|||||||Mixed Models Analysis||||
1677177|NCT01280903|3086054|Superiority|||||||0.895|||||||Mixed Models Analysis||||
1677178|NCT01280903|3086055|Superiority|||||||0.816|||||||Mixed Models Analysis||||
1677179|NCT01280903|3086056|Superiority|||||||0.031||||||p=0.031 for Perceived Therapeutic Efficacy of Exercise and Hypertension|Mixed Models Analysis||||
1677180|NCT01280903|3086056|Superiority|||||||0.001||||||p=0.001 for Perceived Therapeutic Efficacy of Exercise and Arthritis|Mixed Models Analysis||||
1677181|NCT01280903|3086057|Superiority|||||||0.663||||||p=0.663 for Arthritis Self Efficacy Other Symptoms|Mixed Models Analysis||||
1677182|NCT01280903|3086057|Superiority|||||||0.948||||||p=0.948 for Arthritis Self Efficacy Function|Mixed Models Analysis||||
1677183|NCT01280903|3086057|Superiority|||||||0.005||||||p=0.005 for Arthritis Self Efficacy Pain|Mixed Models Analysis||||
1677184|NCT01280903|3086058|Superiority|||||||0.133||||||p=0.133 for Exercise Self-Efficacy|Mixed Models Analysis||||
1677185|NCT01280903|3086058|Superiority|||||||0.71||||||p=0.710 for Exercise Barriers Self-Efficacy|Mixed Models Analysis||||
1677186|NCT01280903|3086059|Superiority|||||||0.979||||||p=0.979 for Short Form-36v2 Physical Component|Mixed Models Analysis||||
1677187|NCT01280903|3086059|Superiority|||||||0.322||||||p=0.322 for Short Form-36v2 Mental Component|Mixed Models Analysis||||
1677188|NCT01280903|3086060|Superiority|||||||0.466|||||||Mixed Models Analysis||||
1677189|NCT01280903|3086061|Superiority|||||||0.639|||||||Mixed Models Analysis||||
1677190|NCT01280903|3086062|Superiority|||||||0.596|||||||Mixed Models Analysis||||
1677191|NCT01280903|3086063|Superiority|||||||0.586|||||||Mixed Models Analysis||||
1677192|NCT01280903|3086064|Superiority|||||||0.424|||||||Mixed Models Analysis||||
1677193|NCT01280903|3086065|Superiority|||||||0.396|||||||Mixed Models Analysis||||
1677194|NCT01280903|3086066|Superiority|||||||0.292|||||||Mixed Models Analysis||||
1677195|NCT01280903|3086067|Superiority|||||||0.856|||||||Mixed Models Analysis||||
1677196|NCT01280903|3086068|Superiority|||||||0.561|||||||Mixed Models Analysis||||
1677197|NCT01280903|3086069|Superiority|||||||0.076||||||p=0.076 for Moderate-to-vigorous|Mixed Models Analysis||||
1677198|NCT01280903|3086069|Superiority|||||||0.823||||||p=0.823 for Light|Mixed Models Analysis||||
1677199|NCT01280903|3086069|Superiority|||||||0.272||||||p=0.272 for None to very low|Mixed Models Analysis||||
1677200|NCT01280903|3086070|Superiority||||||<|0.0001|||||||Mixed Models Analysis||||
1677201|NCT01280903|3086071|Superiority|||||||0.416|||||||Mixed Models Analysis||||
1677202|NCT01280903|3086072|Superiority|||||||0.258|||||||Mixed Models Analysis||||
1677203|NCT01280903|3086073|Superiority|||||||0.18|||||||Mixed Models Analysis||||
1677204|NCT01280903|3086074|Superiority|||||||0.461|||||||Mixed Models Analysis||||
1677205|NCT01280903|3086075|Superiority|||||||0.197||||||p=0.197 for Moderate-to-vigorous|Mixed Models Analysis||||
1677206|NCT01280903|3086075|Superiority|||||||0.573||||||p=0.573 for Light|Mixed Models Analysis||||
1677207|NCT01280903|3086075|Superiority|||||||0.13||||||p=0.130 for None to very low|Mixed Models Analysis||||
1677208|NCT01280903|3086076|Superiority||||||<|0.0001|||||||Mixed Models Analysis||||
1677209|NCT01280695|3086085|Superiority or Other||Median Difference (Net)|-32.0||||0.0022|2-Sided|95.0|-50.0|-12.0|||Wilcoxon (Mann-Whitney)||||
1677210|NCT01280695|3086085|Superiority or Other||Median Difference (Net)|-20.0||||0.0639|2-Sided|95.0|-38.0|1.0|||Wilcoxon (Mann-Whitney)||||
1677211|NCT01280695|3086085|Superiority or Other||Median Difference (Net)|-18.0||||0.0811|2-Sided|95.0|-38.0|4.0|||Wilcoxon (Mann-Whitney)||||
1677212|NCT01280695|3086085|Superiority or Other||Median Difference (Net)|-10.0||||0.4195|2-Sided|95.0|-34.0|14.0|||Wilcoxon (Mann-Whitney)||||
1677213|NCT01280656|3086087|Superiority or Other|||||||0.973|||||||Chi-squared|||Total|
1677214|NCT01280656|3086088|Superiority or Other|||||||0.202|||||||Chi-squared||||
1677215|NCT01280656|3086089|Superiority or Other|||||||0.921|||||||Chi-squared||||
1677216|NCT01280656|3086090|Superiority or Other|||||||0.202|||||||Chi-squared||||
1677217|NCT01280656|3086091|Superiority or Other|||||||0.792|||||||Chi-squared||||
1677218|NCT01280656|3086092|Superiority or Other|||||||0.32|||||||t-test, 2 sided|||Responders vs Non-Responders|
1677219|NCT01280656|3086092|Superiority or Other|||||||0.476|||||||t-test, 2 sided|||Responders vs Non-responders|
1677220|NCT01280656|3086093|Superiority or Other|||||||0.012|||||||Chi-squared|||Mean at home|
1677221|NCT01280656|3086093|Superiority or Other|||||||0.982|||||||Chi-squared|||Mean at the site|
1677222|NCT01280656|3086095|Superiority or Other|||||||0.573|||||||Chi-squared||||
1677223|NCT01280656|3086097|Superiority or Other|||||||0.693|||||||Chi-squared||||
1677224|NCT01280656|3086098|Superiority or Other|||||||0.003|||||||Chi-squared||||
1677225|NCT01280591|3086105|Superiority or Other|||||||0.2734|||||||Cochran-Mantel-Haenszel||||
1677226|NCT01280591|3086107|Superiority or Other|||||||0.0053|||||||Log Rank||||
1677227|NCT01280591|3086108|Superiority or Other|||||||0.0047|||||||Cochran-Mantel-Haenszel||||
1677229|NCT01280591|3086110|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1677230|NCT01280591|3086111|Superiority or Other||||||>|0.05|||||||Cochran-Mantel-Haenszel||||
1677231|NCT01280591|3086112|Superiority or Other|||||||0.0016|||||||Cochran-Mantel-Haenszel||||
1677232|NCT01280591|3086113|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1677233|NCT01280591|3086114|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1677234|NCT01280591|3086115|Superiority or Other|||||||0.0012|||||||Cochran-Mantel-Haenszel||||
1677235|NCT01280591|3086116|Superiority or Other||||||>|0.05|||||||Cochran-Mantel-Haenszel||||
1677236|NCT01280591|3086117|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1677237|NCT01280591|3086118|Superiority or Other|||||||0.0019|||||||Cochran-Mantel-Haenszel||||
1677238|NCT01280591|3086119|Superiority or Other|||||||0.0321|||||||Cochran-Mantel-Haenszel||||
1677239|NCT01280591|3086120|Superiority or Other|||||||0.0027|||||||Cochran-Mantel-Haenszel||||
1677240|NCT01280591|3086121|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1677241|NCT01280591|3086122|Superiority or Other||Mean Difference (Final Values)|11.7|Standard Error of the Mean|2.14||0.0007|2-Sided|95.0|3.7|19.7|||ANCOVA||||
1677242|NCT01280591|3086123|Superiority or Other||Mean Difference (Final Values)|70.4|Standard Error of the Mean|12.85||0.0001|2-Sided|95.0|28.1|112.7|||ANCOVA||||
1677243|NCT01280591|3086124|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1677244|NCT01280591|3086125|Superiority or Other||Mean Difference (Final Values)|-70.3|Standard Error of the Mean|13.17||0.0002|2-Sided|95.0|-106.8|-33.7|||ANCOVA||||
1677245|NCT01280552|3086126|Superiority or Other|||||||0.033||||||Analyses were stratified for age and MGMT methylation status.|Log Rank||||
1677246|NCT01280552|3086128|Superiority or Other|||||||0.01||||||Stratified for age and MGMT methylation status|Log Rank|||Stratified log rank p value stratified for age and MGMT methylation status|
1677247|NCT01279681|3086198|Superiority or Other||Cox Proportional Hazard|1.03||||0.93|2-Sided|95.0|0.49|2.17|||Regression, Cox||||
1677248|NCT01279343|3086212|Superiority||Risk Ratio (RR)|1.03||||0.9|2-Sided|95.0|0.57|1.9|||Chi-squared|||Cesarean deliveries were compared between the groups.|
1677249|NCT01279343|3086212|Superiority||Risk Ratio (RR)|0.99||||0.96|2-Sided|95.0|0.8|1.23|||Chi-squared|||Comparison of vaginal delivery between groups.|
1677250|NCT01279343|3086213|Superiority||Mean Difference (Final Values)|-3.1||||0.03|2-Sided|95.0|-5.9|-0.3|||t-test, 2 sided||||
1677251|NCT01279070|3086227|Superiority or Other||Effect Size|0.3|||<|0.05|2-Sided|95.0|0.01|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups, standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR) assumption.|To evaluate intervention efficacy on the PANSS, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 40 weeks while the baseline value of the PANSS, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.|
1677252|NCT01279070|3086228|Superiority or Other||Effect Size|0.3|||<|0.05|2-Sided|95.0|0.01|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the PANSS, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 16 weeks while the baseline value of the PANSS, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.|
1677253|NCT01279070|3086229|Superiority or Other||Effect Size|0.35|||<|0.05|2-Sided|95.0|0.09|0.6|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the LSP, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 40 weeks while the baseline value of the LSP, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.|
1677254|NCT01279070|3086230|Superiority or Other||Effect Size|0.33|||<|0.05|2-Sided|95.0|0.06|0.6|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the LSP, linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML). An unstructured correlation matrix was used to account for correlation among several observations for each subject. The dependent variable comprised the measures at 16 weeks while the baseline value of the LSP, intervention group (REPYFLEC group vs Leisure group), time and the interaction term (time×treatment) were included as covariates.|
1677255|NCT01279070|3086231|Superiority or Other||Effect Size|0.42|||<|0.05|2-Sided|95.0|0.1|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the BADS(Total score and Key search subtest),linear mixed-effects models were fitted using Restricted Maximum Likelihood(REML).An unstructured correlation matrix was used to account for correlation among several observations for each subject.The dependent variable comprised the measures at 40 weeks while the baseline value of the BADS,intervention group(REPYFLEC group vs Leisure group),time and the interaction term (time×treatment)were included as covariates.|
1677294|NCT01277718|3086343|Superiority or Other||Ratio of LS Means (in %)|85.7|||||2-Sided|90.0|72.51|101.33|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).||
1677256|NCT01279070|3086232|Superiority or Other||Effect size|0.43|||<|0.05|2-Sided|95.0|0.1|0.7|||Mixed Models Analysis||In all the models,adjusted mean difference between the two groups,standardized treatment effect (ES) and confidence intervals were calculated.All the estimates obtained with these models remain unbiased under the missing at random (MAR)assumption.|To evaluate intervention efficacy on the BADS(Total score and Key search subtest),linear mixed-effects models were fitted using Restricted Maximum Likelihood (REML.An unstructured correlation matrix was used to account for correlation among several observations for each subject.The dependent variable comprised the measures at 16 weeks while the baseline value of the BADS,intervention group(REPYFLEC group vs Leisure group),time and the interaction term (time×treatment)were included as covariates.|
1677257|NCT01278862|3086250|Superiority|||||||0.524|||||||Fisher Exact|||null hypothesis no difference in plaque index|
1677258|NCT01278862|3086250|Superiority||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in gingival index|
1677259|NCT01278862|3086251|Superiority or Other||||||>|0.999|||||||Fisher Exact|||Null hypothesis no difference in proximal contact - distal|
1677260|NCT01278862|3086251|Superiority or Other||||||>|0.999|||||||Fisher Exact|||Null hypothesis no difference in Proximal Contact - Mesial|
1677261|NCT01278862|3086251|Superiority||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in crown fracture|
1677262|NCT01278862|3086251|Superiority||||||>|0.999|||||||Fisher Exact|||null hypothesis no difference in margin discoloration|
1677263|NCT01278862|3086251|Superiority or Other||||||>|0.2423|||||||Fisher Exact|||null hypothesis no difference in color match|
1677264|NCT01278797|3086252|Superiority or Other||Mean Difference (Final Values)|0.58||||0.153|||||||ANOVA|ANOVA was applied to TMAX and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg|
1677265|NCT01278797|3086253|Superiority or Other||Test/Reference ratio of geometric means|94.1||||0.0093||90.0|90.7|97.63|||ANOVA|ANOVA was applied to log-transformed CMAX and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg The two formulations are shown to be bioequivalent since the 90% confidence interval of the test to reference ratio is entirely contained within the 80-125% bioequivalence range.|
1677266|NCT01278797|3086254|Superiority or Other||Test/Reference ratio of geometric means|94.51||||0.005||90.0|91.6|97.51|||ANOVA|ANOVA was applied to log-transformed AUC72 and Included treatment, sequence, period and subject-within-sequence effects.||Telmisartan/Amlodipine 80 mg/10 mg versus Telmisartan 80 mg + Amlodipine 10 mg The two formulations are shown to be bioequivalent since the 90% confidence interval of the test to reference ratio is entirely contained within the 80-125% bioequivalence range.|
1677267|NCT01278745|3086267|Superiority or Other|||||||0.0019|||||||ANCOVA|Adjusted for baseline PAV|||
1677268|NCT01278160|3086302|Superiority or Other||Rate ratio|0.56||||0.1687||95.0|0.25|1.27|||Negative binomial regression model||For minor episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.|
1677269|NCT01278160|3086302|Superiority or Other||Rate ratio|0.63||||0.077||95.0|0.38|1.05|||Negative binomial regression model||For diurnal episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.|
1677270|NCT01278160|3086302|Superiority or Other||Rate ratio|1.61||||0.2949||95.0|0.66|3.92|||Negative binomial regression model||For nocturnal episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.|
1677271|NCT01278160|3086302|Superiority or Other||Rate ratio|0.72||||0.1911||95.0|0.43|1.18|||Negative binomial regression model||For all episodes.|The number of hypos was analysed using a negative binomial regression model with a log-link function and the logarithm of the time period in which a hypo is considered emergent as offset. The model included treatment and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors. The rate ratio was estimated and 95% confidence intervals were calculated accordingly.|
1677272|NCT01278160|3086303|Superiority or Other||Odds Ratio (OR)|0.27||||0.1257||95.0|0.05|1.44|||Regression, Logistic|The estimates were from a normal linear regression model with treatment and previous insulin as factors, and baseline value as a covariate|The odds ratio and 95% confidence interval for the HbA1c below or equal to 6.5% treatment target were included.|Responder analyses were based on logistics regression model using treatment and previous therapy (BIAsp 30 OD or insulin glargine OD) as factors and baseline HbA1c as covariate.|
1677273|NCT01278160|3086304|Superiority or Other||Odds Ratio (OR)|0.86||||0.7312||95.0|0.36|2.06|||Regression, Logistic||The odds ratio and 95% confidence interval for the HbA1c below 7% treatment target were included.|Responder analyses were based on logistics regression model using treatment and previous therapy (BIAsp 30 OD or insulin glargine OD) as factors and baseline HbA1c as covariate.|
1677274|NCT01278160|3086305|Superiority or Other||Mixed model analysis|-0.04||||0.8424||95.0|-0.47|0.38|||Mixed Models Analysis||Confidence interval is before breakfast the following day profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.|
1677292|NCT01277822|3086321|Non-Inferiority or Equivalence|Non-inferiority margin was 3 mmHg as Korean Food and Drug Administration (KFDA) guidance.|Mean Difference (Final Values)|-1.3|Standard Deviation|7.7||0.1339|2-Sided|95.0|-3.0|0.4|||t-test, 2 sided|Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|||
1677399|NCT01276639|3086486|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1677400|NCT01276639|3086486|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1677275|NCT01278160|3086305|Superiority or Other||Mixed model analysis|0.3||||0.2198||95.0|-0.18|0.79||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is 2.00 - 4.00 a.m. profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.|
1677276|NCT01278160|3086305|Superiority or Other||Mixed model analysis|-0.25||||0.4063||95.0|-0.84|0.34||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is bedtime profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.|
1677277|NCT01278160|3086305|Superiority or Other||Mixed model analysis|0.03||||0.9327||95.0|-0.63|0.69||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after dinner profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.|
1677278|NCT01278160|3086305|Superiority or Other||Mixed model analysis|0.44||||0.1591||95.0|-0.17|1.04||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before dinner profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.|
1677279|NCT01278160|3086305|Superiority or Other||Mixed model analysis|0.3||||0.4614||95.0|-0.5|1.11||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after lunch profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.|
1677280|NCT01278160|3086305|Superiority or Other||Mixed model analysis|0.35||||0.2843||95.0|-0.29|0.99||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before lunch profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.|
1677281|NCT01278160|3086305|Superiority or Other||Mixed models analysis|0.09||||0.812||95.0|-0.63|0.8||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is two hours after breakfast profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp-30 once daily (OD)/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.|
1677282|NCT01278160|3086305|Superiority or Other||Mixed models analysis|0.2||||0.2569||95.0|-0.15|0.56||P-value for parallelism was overall test for parallel time profiles between treatment groups, i.e. time by treatment group interaction effect.|Mixed Models Analysis||Confidence interval is before breakfast profile|A mixed effect model was fitted to the 9-point SMPG profile data. The model included treatment, time, interaction between treatment and time and previous therapy (BIAsp 30 OD/insulin glargine OD) as factors and subject as random effect. From the model, mean profile by treatment and relevant treatment differences was estimated and explored.|
1677283|NCT01278160|3086306|Superiority or Other||Mean Difference (Net)|-0.01|Standard Error of the Mean|0.12||||95.0|-0.24|0.22||||||The null hypothesis is H0: μBIAsp 30 (2:1) – μBIAsp 30 (1:1) = 0 against the alternative hypothesis HA: μBIAsp 30 (2:1) – μBIAsp 30 (1:1) ≠ 0. This trial is an extension to BIAsp-3756 (NCT01123980), hence no particular sample size calculation was made.|
1677284|NCT01277822|3086314|Superiority or Other|||||||0.5933||||||Right ankle: Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|t-test, 2 sided||||
1677285|NCT01277822|3086314|Superiority or Other|||||||0.7911||||||Left ankle: Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|t-test, 2 sided||||
1677286|NCT01277822|3086315|Superiority or Other|||||||0.6646|||||||Chi-squared||||
1677287|NCT01277822|3086316|Superiority or Other|||||||0.2508||||||No imputation for missing data was performed|Chi-squared||||
1677288|NCT01277822|3086317|Superiority or Other|||||||0.2508||||||No imputation for missing data was performed|Chi-squared||||
1677289|NCT01277822|3086318|Superiority or Other|||||||0.8736|||||||t-test, 2 sided|No imputation for missing data was performed|||
1677290|NCT01277822|3086319|Superiority or Other|||||||0.0717|||||||t-test, 2 sided|Last observed non-missing, post-baseline value was imputed for missing value. If no such value existed, the value was treated as missing in analysis|||
1677291|NCT01277822|3086320|Superiority or Other|||||||0.4478||||||No imputation for missing data was performed|t-test, 2 sided||||
1677293|NCT01277718|3086343|Superiority or Other||Ratio of LS Means (in %)|85.9|||||2-Sided|90.0|72.94|101.17|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).||
1677295|NCT01277718|3086343|Superiority or Other||Ratio of LS Means (in %)|100.0|||||2-Sided|90.0|85.09|118.03|||||LS mean was calculated from ANOVA. Data for Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).||
1677296|NCT01277718|3086344|Superiority or Other||Ratio of LS Means (in %)|106.0|||||2-Sided|90.0|94.53|119.91|||||LS mean was calculated from ANOVA. Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).||
1677297|NCT01277718|3086344|Superiority or Other||Ratio of LS Means (in %)|96.2|||||2-Sided|90.0|85.06|108.77|||||LS mean was calculated from ANOVA. Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).||
1677298|NCT01277718|3086344|Superiority or Other||Ratio of Least Squares (LS) Means (in %)|111.0|||||2-Sided|90.0|98.02|124.99|||||LS mean was calculated from Analysis of variance (ANOVA). Data for AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).||
1677299|NCT01277666|3086346|Superiority or Other||Mean Difference (Net)|1.85|Standard Error of the Mean|2.697||0.493|2-Sided|95.0|-3.45|7.15||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 12|
1677300|NCT01277666|3086346|Superiority or Other||Mean Difference (Net)|3.37|Standard Error of the Mean|2.467||0.173|2-Sided|95.0|-1.48|8.21||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 8|
1677301|NCT01277666|3086346|Superiority or Other||Mean Difference (Net)|-0.34|Standard Error of the Mean|2.652||0.898|2-Sided|95.0|-5.55|4.87||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 12|
1677302|NCT01277666|3086346|Superiority or Other||Mean Difference (Net)|-1.13|Standard Error of the Mean|2.426||0.642|2-Sided|95.0|-5.89|3.64||P-values were obtained from an analysis of covariance model with baseline score as the covariate.|ANCOVA|||Week 8|
1677303|NCT01277666|3086347|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.43|2-Sided|95.0|-8.5|3.7|||Mantel Haenszel||||
1677304|NCT01277666|3086347|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.541|2-Sided|95.0|-8.1|4.2|||Mantel Haenszel||||
1677305|NCT01277666|3086348|Superiority or Other||Mean Difference (Final Values)|0.6||||0.889|2-Sided|95.0|-7.8|9.0|||Mantel Haenszel||||
1677306|NCT01277666|3086348|Superiority or Other||Mean Difference (Final Values)|2.0||||0.633|2-Sided|95.0|-6.5|10.4|||Mantel Haenszel||||
1677307|NCT01277666|3086349|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.709|2-Sided|95.0|-6.1|4.1|||Mantel Haenszel||||
1677308|NCT01277666|3086349|Superiority or Other||Mean Difference (Final Values)|0.0||||0.985|2-Sided|95.0|-5.2|5.2|||Mantel Haenszel||||
1677309|NCT01277666|3086350|Superiority or Other||Mean Difference (Final Values)|3.5||||0.354|2-Sided|95.0|-3.9|10.9|||Mantel Haenszel||||
1677310|NCT01277666|3086350|Superiority or Other||Mean Difference (Final Values)|3.0||||0.415|2-Sided|95.0|-4.4|10.3|||Mantel Haenszel||||
1677311|NCT01277666|3086351|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.475|2-Sided|95.0|-9.2|4.4|||Mantel Haenszel||||
1677312|NCT01277666|3086351|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.592|2-Sided|95.0|-8.8|4.8|||Mantel Haenszel||||
1677313|NCT01277666|3086352|Superiority or Other||Mean Difference (Final Values)|2.1||||0.648|2-Sided|95.0|-6.5|10.7|||Mantel Haenszel|||comparison of Placebo and GSK1605786A 500 mg twice daily|
1677314|NCT01277666|3086352|Superiority or Other||Mean Difference (Final Values)|2.5||||0.546|2-Sided|95.0|-6.1|11.0|||Mantel Haenszel|||comparison of Placebo and GSK1605786A 500 mg once daily|
1677315|NCT01277601|3086366|Superiority or Other|||||||0.002||||||Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.|Log Rank||||
1677316|NCT01277601|3086366|Superiority or Other||||||<|0.001||||||Raw p-values comparing treatments were based on a log-rank test stratified by HBeAg status and viral genotype.|Log Rank||||
1677317|NCT01277523|3086374|Superiority or Other||Hazard Ratio (HR)|0.6||||0.1168|2-Sided|95.0|0.32|1.14|||Regression, Cox||||
1677318|NCT01277523|3086374|Superiority or Other||Hazard Ratio (HR)|0.75||||0.3567|2-Sided|95.0|0.41|1.38|||Regression, Cox||||
1677319|NCT01277523|3086375|Superiority or Other||Hazard Ratio (HR)|2.06||||0.5557|2-Sided|95.0|0.19|22.7|||Regression, Cox||||
1677320|NCT01277523|3086375|Superiority or Other||Hazard Ratio (HR)|1.06||||0.9671|2-Sided|95.0|0.07|16.95|||Regression, Cox||||
1677321|NCT01277523|3086376|Superiority or Other||Mean Difference (Final Values)|0.021|Standard Error of the Mean|0.082||0.795|2-Sided|95.0|-0.14|0.182|||Mixed Models Analysis||||
1677322|NCT01277523|3086376|Superiority or Other||Mean Difference (Final Values)|0.089|Standard Error of the Mean|0.083||0.2841|2-Sided|95.0|-0.074|0.252|||Mixed Models Analysis||||
1677323|NCT01277523|3086377|Superiority or Other||Mean Difference (Final Values)|-0.049|Standard Error of the Mean|0.093||0.5954|2-Sided|95.0|-0.232|0.133|||Mixed Models Analysis||||
1677324|NCT01277523|3086377|Superiority or Other||Mean Difference (Final Values)|-0.032|Standard Error of the Mean|0.094||0.7309|2-Sided|95.0|-0.217|0.153|||Mixed Models Analysis||||
1677325|NCT01277523|3086378|Superiority or Other||Mean Difference (Final Values)|-0.058|Standard Error of the Mean|0.151||0.703|2-Sided|95.0|-0.355|0.239|||Mixed Models Analysis||||
1677326|NCT01277523|3086378|Superiority or Other||Mean Difference (Final Values)|-0.001|Standard Error of the Mean|0.153||0.996|2-Sided|95.0|-0.301|0.3|||Mixed Models Analysis||||
1677327|NCT01277523|3086380|Superiority or Other||Mean Difference (Final Values)|0.036|Standard Error of the Mean|0.081||0.6558|2-Sided|95.0|-0.123|0.196|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1677328|NCT01277523|3086380|Superiority or Other||Mean Difference (Final Values)|0.058|Standard Error of the Mean|0.082||0.4762|2-Sided|95.0|-0.102|0.219|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1677329|NCT01277523|3086382|Superiority or Other||Mean Difference (Final Values)|0.053|Standard Error of the Mean|0.088||0.5448|2-Sided|95.0|-0.119|0.226|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1677401|NCT01276639|3086486|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1677330|NCT01277523|3086382|Superiority or Other||Mean Difference (Final Values)|0.118|Standard Error of the Mean|0.088||0.1819|2-Sided|95.0|-0.055|0.292|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1677331|NCT01277523|3086383|Superiority or Other||Mean Difference (Final Values)|0.052|Standard Error of the Mean|0.056||0.3549|2-Sided|95.0|-0.058|0.163|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1677332|NCT01277523|3086383|Superiority or Other||Mean Difference (Final Values)|0.087|Standard Error of the Mean|0.057||0.1252|2-Sided|95.0|-0.024|0.198|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1677333|NCT01277523|3086384|Superiority or Other||Mean Difference (Final Values)|0.087|Standard Error of the Mean|0.053||0.0999|2-Sided|95.0|-0.017|0.191|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1677334|NCT01277523|3086384|Superiority or Other||Mean Difference (Final Values)|0.113|Standard Error of the Mean|0.053||0.0338|2-Sided|95.0|0.009|0.217|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1677335|NCT01277523|3086385|Superiority or Other||Mean Difference (Final Values)|0.063|Standard Error of the Mean|0.059||0.2845|2-Sided|95.0|-0.053|0.179|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1677336|NCT01277523|3086385|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.059||0.1264|2-Sided|95.0|-0.026|0.207|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1677337|NCT01277523|3086386|Superiority or Other||Mean Difference (Final Values)|0.054|Standard Error of the Mean|0.058||0.3605|2-Sided|95.0|-0.061|0.168||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1677338|NCT01277523|3086386|Superiority or Other||Mean Difference (Final Values)|0.115|Standard Error of the Mean|0.059||0.0509|2-Sided|95.0|0.0|0.231||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1677339|NCT01277523|3086387|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.055||0.1039|2-Sided|95.0|-0.019|0.198||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1677340|NCT01277523|3086387|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|0.055||0.0457|2-Sided|95.0|0.002|0.22||Stepwise testing of the null hypothesis was used to test the efficacy of Tio R5 and then Tio R2.5, each over placebo.|Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1677341|NCT01277510|3086388|Superiority or Other||LS Mean Difference|-0.8||||0.854|2-Sided|95.0|-9.4|7.9|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo||
1677342|NCT01277510|3086390|Superiority or Other||LS Mean Difference|0.2||||0.896|2-Sided|95.0|-3.1|3.6||No adjustments for multiplicity were made.|ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo||
1677343|NCT01277510|3086391|Superiority or Other||LS Mean Difference|-10.0||||0.117|2-Sided|95.0|-22.5|2.6|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was > 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if > 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.|
1677344|NCT01277510|3086392|Superiority or Other||LS Mean Difference|-5.3||||0.454|2-Sided|95.0|-19.4|8.9|||ANCOVA|Baseline age group was used as covariate|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was > 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if > 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.|
1677345|NCT01277510|3086393|Superiority or Other||LS Mean Difference|-3.7||||0.147|2-Sided|95.0|-8.6|1.3|||ANCOVA|Baseline age group was used as covariate.|Cinacalcet-Placebo|The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was > 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if > 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.|
1677346|NCT01277510|3086394|Superiority or Other||Difference (Cinacalcet - Placebo)|3.46||||0.826|2-Sided|95.0|-22.58|29.51|||Cochran-Mantel-Haenszel|Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -<12 years old or 12 - <18 years old).||The secondary endpoint with the smallest p-value was first compared at a significance level of 0.0125. If the p-value was > 0.0125, all 4 secondary endpoints were non-significant; if ≤ 0.0125, the null hypothesis for that endpoint was rejected. Next, the 2nd smallest p-value was compared at a level of 0.0167; if > 0.0167, the remaining 3 endpoints were not significant, or, the null hypothesis of that endpoint was rejected. The other 2 endpoints were analyzed similarly, at 0.025 and 0.05.|
1677347|NCT01277510|3086395|Superiority or Other||Difference (Cinacalcet - Placebo)|35.5||||0.017|2-Sided|95.0|8.76|62.24|||Cochran-Mantel-Haenszel|Cochran- Mantel-Haenszel (CMH) test stratified by baseline age group (6 -<12 years old or 12 - <18 years old).||A hierarchical testing procedure was used to test the primary and biochemical secondary endpoints (Outcome Measures 1-5). The primary endpoint was tested at a significance level of 0.05. The four biochemical secondary endpoints were to be tested using Holm’s method at 0.05 should the primary endpoint achieve a significant result.|
1677368|NCT01277211|3086407|Superiority or Other||Difference in Percentages, Cycle 7|-3.7||||0.11|2-Sided|95.0|-9.4|0.8|||Miettinen and Nurminen method|||For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677369|NCT01277211|3086407|Superiority or Other||Difference in Percentages, Cycle 6|-3.9||||0.089|2-Sided|95.0|-9.5|0.5|||Miettinen and Nurminen method|||For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677348|NCT01277302|3086405|Superiority or Other||Estimated interaction effect|0.071|Standard Error of the Mean|0.107||0.5091||||||This is the p-value of the treatment by time interaction in the longitudinal model. Analysis was not adjusted for multiple comparisons as there was only 1 comparison. p < 0.05 (2-sided) was required for significance.|Longitudinal mixed model|The analysis was stratified by disease (BRVO or CRVO), randomization month, and randomization BCVA score category (≤35, >35 to ≤50, or >50 letters).||The null hypothesis was that there was no difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 treatment groups as assessed by the interaction term of treatment by time in a longitudinal model.|
1677349|NCT01277211|3086406|Superiority or Other||Difference in Percentages, Cycle 13|-4.5||||0.043|2-Sided|95.0|-10.2|-0.1|||Miettinen and Nurminen method|||For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677350|NCT01277211|3086406|Superiority or Other||Difference in Percentages, Cycle 12|-6.2||||0.002|2-Sided|95.0|-11.7|-2.1|||Miettinen and Nurminen method|||For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677351|NCT01277211|3086406|Superiority or Other||Difference in Percentages, Cycle 11|-4.4||||0.009|2-Sided|95.0|-9.4|-1.0|||Miettinen and Nurminen method|||For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677352|NCT01277211|3086406|Superiority or Other||Difference in Percentages, Cycle 10|-2.9||||0.098|2-Sided|95.0|-7.6|0.5|||Miettinen and Nurminen method|||For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677353|NCT01277211|3086406|Superiority or Other||Difference in Percentages, Cycle 9|-4.2||||0.027|2-Sided|95.0|-9.3|-0.4|||Miettinen and Nurminen method|||For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677354|NCT01277211|3086406|Superiority or Other||Difference in Percentages, Cycle 8|-1.9||||0.308|2-Sided|95.0|-6.7|1.6|||Miettinen and Nurminen method|||For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677355|NCT01277211|3086406|Superiority or Other||Difference in Percentages, Cycle 7|-4.1||||0.019|2-Sided|95.0|-9.0|-0.6|||Miettinen and Nurminen method|||For Cycle 7, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677356|NCT01277211|3086406|Superiority or Other||Difference in Percentages, Cycle 6|-3.9||||0.062|2-Sided|95.0|-9.3|0.2|||Miettinen and Nurminen method|||For Cycle 6, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677357|NCT01277211|3086406|Superiority or Other||Difference in Percentages, Cycle 5|-1.0||||0.609|2-Sided|95.0|-5.7|2.5|||Miettinen and Nurminen method|||For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677358|NCT01277211|3086406|Superiority or Other||Difference in Percentages, Cycle 4|-3.6||||0.044|2-Sided|95.0|-8.5|-0.1|||Miettinen and Nurminen method|||For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677359|NCT01277211|3086406|Superiority or Other||Difference in Percentages, Cycle 3|-6.5||||0.002|2-Sided|95.0|-12.0|-2.2|||Miettinen and Nurminen method|||For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677360|NCT01277211|3086406|Superiority or Other||Difference in Percentages, Cycle 2|-4.9||||0.012|2-Sided|95.0|-10.1|-1.0|||Miettinen and Nurminen method|||For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677361|NCT01277211|3086406|Superiority or Other||Difference in Percentages, Cycle 1|-6.0||||0.015|2-Sided|95.0|-12.0|-1.1|||Miettinen and Nurminen method|||For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677362|NCT01277211|3086407|Superiority or Other||Difference in Percentages, Cycle 13|-4.5||||0.048|2-Sided|95.0|-10.4|0.0|||Miettinen and Nurminen method|||For Cycle 13, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677363|NCT01277211|3086407|Superiority or Other||Difference in Percentages, Cycle 12|-4.4||||0.037|2-Sided|95.0|-9.9|-0.2|||Miettinen and Nurminen method|||For Cycle 12, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677364|NCT01277211|3086407|Superiority or Other||Difference in Percentages, Cycle 11|-3.8||||0.046|2-Sided|95.0|-8.9|-0.1|||Miettinen and Nurminen method|||For Cycle 11, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677365|NCT01277211|3086407|Superiority or Other||Difference in Percentages, Cycle 10|-4.4||||0.041|2-Sided|95.0|-10.0|-0.2|||Miettinen and Nurminen method|||For Cycle 10, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677366|NCT01277211|3086407|Superiority or Other||Difference in Percentages, Cycle 9|-1.1||||0.621|2-Sided|95.0|-6.2|2.9|||Miettinen and Nurminen method|||For Cycle 9, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677367|NCT01277211|3086407|Superiority or Other||Difference in Percentages, Cycle 8|-4.3||||0.049|2-Sided|95.0|-9.8|0.0|||Miettinen and Nurminen method|||For Cycle 8, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677397|NCT01276639|3086485|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1677398|NCT01276639|3086485|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1677370|NCT01277211|3086407|Superiority or Other||Difference in Percentages, Cycle 5|-1.3||||0.556|2-Sided|95.0|-6.4|2.6|||Miettinen and Nurminen method|||For Cycle 5, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677371|NCT01277211|3086407|Superiority or Other||Difference in Percentages, Cycle 4|-8.0||||0.001|2-Sided|95.0|-14.0|-2.9|||Miettinen and Nurminen method|||For Cycle 4, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677372|NCT01277211|3086407|Superiority or Other||Difference in Percentages, Cycle 3|-5.8||||0.019|2-Sided|95.0|-11.8|-0.9|||Miettinen and Nurminen method|||For Cycle 3, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677373|NCT01277211|3086407|Superiority or Other||Difference in Percentages, Cycle 2|-6.2||||0.029|2-Sided|95.0|-12.7|-0.6|||Miettinen and Nurminen method|||For Cycle 2, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677374|NCT01277211|3086407|Superiority or Other||Difference in Percentages, Cycle 1|-3.0||||0.346|2-Sided|95.0|-9.9|3.1|||Miettinen and Nurminen method|||For Cycle 1, a two-sided 95% CI for the difference in percentage between the treatment groups (ENG-EE vs. DRSP-EE) was calculated using the method of Miettinen and Nurminen.|
1677375|NCT01277211|3086408|Superiority or Other||Ratio of Pearl Indices|0.61||||0.531|2-Sided|95.0|0.19|2.29|||Poisson distribution method|Differences between treatment groups was explored using an exact 95% CI for the ratio of the two Pearl Indices based on the Poisson distribution.||Differences between the two treatment groups (ENG-EE vs. DRSP-EE) were explored using an exact 95% CI for the Ratio of the two Pearl Indices based on the Poisson distribution.|
1677376|NCT01277081|3086412|Superiority or Other||Adjusted Mean Difference|0.52|||<|0.0001|2-Sided|95.0|0.38|0.67|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered two treatments being compared to be equal for cold symptom score after 60 minutes.|
1677377|NCT01277081|3086413|Superiority or Other||Adjusted mean difference|0.5|||<|0.0001|2-Sided|95.0|0.36|0.65|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null Hypothesis considered no difference in treatments being compared for cold symptoms score after 60 minutes.|
1677378|NCT01277081|3086414|Superiority or Other||Adjusted Mean Difference|0.58|||<|0.0001|2-Sided|95.0|0.44|0.72|||Repeated measures analysis|Repeated measures analysis with factors for time and treatment*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered no difference in treatments being compared for breathing score over 60 minutes.|
1677379|NCT01277081|3086415|Superiority or Other||Adjusted Mean difference|0.72|||<|0.0001|2-Sided|95.0|0.58|0.86|||Repeated Measure Analysis|Repeated measures analysis with factors for time and treatment*time interaction. Baseline score was adjusted as part of the repeated measures series.|Difference was first named treatment minus second named treatment such that a positive difference favours the first named treatment|Null Hypothesis considered no difference in treatments being compared for breathing score over the first 15 minutes compared to baseline.|
1677380|NCT01276847|3086425|Superiority or Other|||||||0.098||||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16|
1677381|NCT01276847|3086425|Superiority or Other|||||||0.053||||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4|
1677382|NCT01276847|3086425|Superiority or Other|||||||0.577||||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2|
1677383|NCT01276847|3086425|Superiority or Other|||||||0.787||||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1|
1677384|NCT01276847|3086426|Superiority or Other|||||||0.000215||||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16|
1677385|NCT01276847|3086426|Superiority or Other|||||||0.002||||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4|
1677386|NCT01276847|3086426|Superiority or Other|||||||0.01||||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2|
1677387|NCT01276847|3086426|Superiority or Other|||||||0.397||||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1|
1677388|NCT01276847|3086427|Superiority or Other|||||||0.000184||||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 16|
1677389|NCT01276847|3086427|Superiority or Other|||||||0.00015||||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 4|
1677390|NCT01276847|3086427|Superiority or Other|||||||0.007||||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 2|
1677391|NCT01276847|3086427|Superiority or Other|||||||0.016||||||unadjusted 1-sided p-value, α = 0.05|Wilcoxon (Mann-Whitney)|One-sample test||Week 1|
1677392|NCT01276821|3086434|Non-Inferiority or Equivalence|Non - Inferiority Analysis|Mean Difference (Final Values)|1.33|Standard Deviation|1.3|<|0.05|2-Sided|95.0|0.78|1.82|||t-test, 2 sided|||"Null Hypothesis Efficacy of nebulised hypertonic saline (3%) with L-Epinephrine is not higer than as compared to L-Epinephrine given with 0.9% normal saline in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis.~Alternate Hypothesis:~Nebulised hypertonic saline (3%) with L-Epinephrine is superior to 0.9% Normal saline with L-Epinephrine in the management of children aged 6 weeks to 24 months with mild to moderately severe bronchiolitis."|
1677393|NCT01276639|3086484|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1677394|NCT01276639|3086484|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1677395|NCT01276639|3086484|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1677396|NCT01276639|3086485|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1677402|NCT01276639|3086490|Superiority or Other||LS mean difference|-27.33|Standard Error of the Mean|13.22||0.0391|2-Sided|95.0|-53.29|-1.37|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.|
1677403|NCT01276639|3086490|Superiority or Other||LS mean difference|-97.03|Standard Error of the Mean|17.47|<|0.0001|2-Sided|95.0|-131.35|-62.72||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677404|NCT01276639|3086490|Superiority or Other||LS mean difference|-69.7|Standard Error of the Mean|17.6|<|0.0001|2-Sided|95.0|-104.27|-35.13||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677405|NCT01276639|3086491|Superiority or Other||Percent difference|5.09|Standard Error of the Mean|2.5||0.0415|2-Sided|95.0|0.19|9.98|||Normal approximation||||
1677406|NCT01276639|3086491|Superiority or Other||Odds Ratio (OR)|11.55|||<|0.0001|2-Sided|95.0|3.64|59.98||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677407|NCT01276639|3086491|Superiority or Other||Odds Ratio (OR)|6.76|||<|0.0003|2-Sided|95.0|2.11|35.77||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677408|NCT01276639|3086492|Superiority or Other||Percent difference|5.98|Standard Error of the Mean|2.97||0.0443|2-Sided|95.0|0.15|11.8|||Normal approximation||||
1677409|NCT01276639|3086492|Superiority or Other||Odds Ratio (OR)|11.53|||<|0.0001|2-Sided|95.0|5.06|54.42||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677410|NCT01276639|3086492|Superiority or Other||Odds Ratio (OR)|8.34|||<|0.0001|2-Sided|95.0|3.23|35.12||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677411|NCT01276639|3086493|Superiority or Other||LS mean difference|-1.99|Standard Error of the Mean|0.42|<|0.0001|2-Sided|95.0|-2.8|-1.17|||Mixed Models Analysis|||Week 16: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.|
1677412|NCT01276639|3086493|Superiority or Other||LS mean difference|-6.97|Standard Error of the Mean|0.53|<|0.0001|2-Sided|95.0|-8.0|-5.94||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677413|NCT01276639|3086493|Superiority or Other||LS mean difference|-4.98|Standard Error of the Mean|0.53|<|0.0001|2-Sided|95.0|-6.02|-3.95||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 16: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677414|NCT01276639|3086493|Superiority or Other||LS mean difference|-0.81|Standard Error of the Mean|0.35|<|0.0212|2-Sided|95.0|-1.5|-0.12|||Mixed Models Analysis|||Week 4: LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.|
1677415|NCT01276639|3086493|Superiority or Other||LS mean difference|-4.71|Standard Error of the Mean|0.43|<|0.0001|2-Sided|95.0|-5.56|-3.86||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week 4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677416|NCT01276639|3086493|Superiority or Other||LS mean difference|-3.9|Standard Error of the Mean|0.43|<|0.0001|2-Sided|95.0|-4.75|-3.05||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||Week4: For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677417|NCT01276639|3086495|Superiority or Other||Percent difference|19.61|Standard Error of the Mean|3.32|<|0.0001|2-Sided|95.0|13.1|26.11|||Normal approximation||||
1677418|NCT01276639|3086495|Superiority or Other||Odds Ratio (OR)|98.05|||<|0.0001|2-Sided|95.0|23.49|5689.8||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677419|NCT01276639|3086495|Superiority or Other||Odds Ratio (OR)|34.55|||<|0.0001|2-Sided|95.0|7.46|1786.9||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested at significance level of 0.025 (2-sided).|Cochran-Mantel-Haenszel|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16, PASI90 response at Week 16, change in DLQI total score at Week 16, PGA response at Week 4, PASI75 response at Week 4, change in DLQI total score at Week 4, percent change in NAPSI score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677420|NCT01276639|3086496|Superiority or Other||LS mean difference|-15.26|Standard Error of the Mean|3.46|<|0.0001|2-Sided|95.0|-22.04|-8.48|||Mixed Models Analysis|||LS mean difference was derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction, baseline value and repeated measures for visit. Unstructured covariance matrix was used.|
1677421|NCT01276639|3086496|Superiority or Other||LS mean difference|-68.82|Standard Error of the Mean|4.34|<|0.0001|2-Sided|95.0|-77.33|-60.31||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677422|NCT01276639|3086496|Superiority or Other||Least squares (LS) mean difference|-53.56|Standard Error of the Mean|4.34|<|0.0001|2-Sided|95.0|-62.08|-45.04||Mixed model analysis with fixed effects for treatment, visit, treatment-by-visit interaction,baseline value and repeated measures for visit. Unstructured covariance matrix was used. Each hypothesis was tested at significance level of 0.025 (2-sided).|Mixed Models Analysis|||For key secondary endpoint, family-wise step-down procedure was used to control Type I error. Sequential order of testing: percent change in BSA at Week 16,PASI90 response at Week 16, change in Dermatology Life Quality Index(DLQI) total score at Week 16,PGA response at Week 4,PASI75 at Week 4, change in DLQI total score at Week 4, percent change in Nail Psoriasis Severity Index(NAPSI) score at Week 16. If comparison at preceding step was significant, then subsequent comparisons were significant.|
1677423|NCT01276639|3086497|Superiority or Other||Percent difference|19.22|Standard Error of the Mean|3.65|<|0.0001|2-Sided|95.0|12.07|26.37|||Normal approximation||||
1677424|NCT01276639|3086497|Superiority or Other||Odds Ratio (OR)|20.81|||<|0.0001|2-Sided|95.0|11.9|49.86||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.|
1677448|NCT01276327|3086528|Non-Inferiority or Equivalence|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|94.17|Standard Error of the Mean|1.03|||2-Sided|90.0|89.08|99.55|||||Geometric Standard error of mean was calculated.||
1677503|NCT01275170|3086661|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||2-Sided|90.0|0.61|1.06|||||||
1677504|NCT01275170|3086661|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.95|||||2-Sided|90.0|0.72|1.26|||||||
1677425|NCT01276639|3086497|Superiority or Other||Odds Ratio (OR)|8.93|||<|0.0001|2-Sided|95.0|5.25|21.84||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.|
1677426|NCT01276639|3086498|Superiority or Other||Percent difference|17.29|Standard Error of the Mean|3.66|<|0.0001|2-Sided|95.0|10.11|24.47|||Normal approximation||||
1677427|NCT01276639|3086498|Superiority or Other||Odds Ratio (OR)|12.45|||<|0.0001|2-Sided|95.0|9.01|31.88||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.|
1677428|NCT01276639|3086498|Superiority or Other||Odds Ratio (OR)|6.46|||<|0.0001|2-Sided|95.0|4.4|15.03||Cochran-Mantel-Haenszel statistics adjusted for pooled investigator sites was used for the analysis. Each hypothesis was tested against placebo at significance level of 0.05 (2-sided).|Cochran-Mantel-Haenszel|||For primary endpoint, step-down procedure used to preserve Type I error, sequential order of testing: PGA response for CP-690,550 10 mg versus (vs) placebo at Week 16; Psoriasis Area and Severity Index 75 (PASI75) response for CP-690,550 10 mg vs placebo at Week 16; PGA response for CP-690,550 5 mg vs placebo at Week 16; PASI75 response for CP-690,550 5 mg vs placebo at Week 16. If comparison at preceding step was significant, only then subsequent comparisons were significant.|
1677429|NCT01276535|3086499|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|||Comparison is made of the combined application of the Erchonia MLS and the Erchonia THL. Results are analyzed at 6 weeks relative to Baseline.|
1677430|NCT01276535|3086500|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|||Comparison is made of the combined application of the Erchonia MLS and the Erchonia THL. Results are analyzed at 6 weeks relative to Baseline.|
1677431|NCT01276509|3086511|Superiority or Other||Difference in Percentage|0.066|Standard Error of the Mean|0.111||0.2755|2-Sided|90.0|-0.116|0.248|||Mixed Models Analysis|||Difference from placebo at week 12|
1677432|NCT01276509|3086511|Superiority or Other||Difference in Percentage|0.055|Standard Error of the Mean|0.116||0.3169|2-Sided|90.0|-0.136|0.246|||Mixed Models Analysis|||Difference from placebo at week 12|
1677433|NCT01276509|3086511|Superiority or Other||Difference in Percentage|0.038|Standard Error of the Mean|0.112||0.3661|2-Sided|90.0|-0.146|0.222|||Mixed Models Analysis|||Difference from placebo at week 12|
1677434|NCT01276509|3086511|Superiority or Other||Difference in Percentage|0.102|Standard Error of the Mean|0.1||0.1529|2-Sided|90.0|-0.062|0.266|||Mixed Models Analysis|||Difference from placebo at week 8|
1677435|NCT01276509|3086511|Superiority or Other||Difference in Percentage|0.071|Standard Error of the Mean|0.099||0.2378|2-Sided|90.0|-0.092|0.234|||Mixed Models Analysis|||Difference from placebo at week 8|
1677436|NCT01276509|3086511|Superiority or Other||Difference in Percentage|0.124|Standard Error of the Mean|0.107||0.1234|2-Sided|90.0|-0.052|0.299|||Mixed Models Analysis|||Difference from placebo at week 8|
1677437|NCT01276509|3086514|Superiority or Other||Difference in Percentage|-0.011|Standard Error of the Mean|0.114||0.5385|2-Sided|90.0|-0.198|0.176|||Mixed Models Analysis|||Difference from placebo at Week 12|
1677438|NCT01276509|3086514|Superiority or Other||Difference in Percentage|0.061|Standard Error of the Mean|0.117||0.3005|2-Sided|90.0|-0.131|0.253|||Mixed Models Analysis|||Difference from placebo at Week 12|
1677439|NCT01276509|3086514|Superiority or Other||Difference in Percentage|0.034|Standard Error of the Mean|0.117||0.3864|2-Sided|90.0|-0.158|0.225|||Mixed Models Analysis|||Difference from placebo at Week 12|
1677440|NCT01276509|3086514|Superiority or Other||Difference in Percentage|0.15|Standard Error of the Mean|0.113||0.0922|2-Sided|90.0|-0.036|0.335|||Mixed Models Analysis|||Difference from placebo at Week 8|
1677441|NCT01276509|3086514|Superiority or Other||Difference in Percentage|0.124|Standard Error of the Mean|0.117||0.1433|2-Sided|90.0|-0.068|0.316|||Mixed Models Analysis|||Difference from placebo at Week 8|
1677442|NCT01276509|3086514|Superiority or Other||Difference in Percentage|0.05|Standard Error of the Mean|0.121||0.3393|2-Sided|90.0|-0.149|0.249|||Mixed Models Analysis|||Difference from placebo at Week 8|
1677443|NCT01276327|3086523|Non-Inferiority or Equivalence|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|80.79|Standard Error of the Mean|1.04|||2-Sided|90.0|75.6|86.34|||||Geometric standard error of mean was calculated.||
1677444|NCT01276327|3086524|Non-Inferiority or Equivalence|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|101.85|Standard Error of the Mean|1.02|||2-Sided|90.0|98.18|105.67|||||Geometric standard error of mean was calculated.||
1677445|NCT01276327|3086525|Non-Inferiority or Equivalence|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|99.92|Standard Error of the Mean|1.02|||2-Sided|90.0|97.1|102.81|||||Geometric Standard error of mean was calculated.||
1677446|NCT01276327|3086526|Non-Inferiority or Equivalence|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|97.31|Standard Error of the Mean|1.06|||2-Sided|90.0|88.9|106.51|||||Geometric standard error of mean was calculated.||
1677447|NCT01276327|3086527|Non-Inferiority or Equivalence|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together.|Adjusted gMean Ratio (Test/Ref) (%)|79.99|Standard Error of the Mean|1.04|||2-Sided|90.0|74.65|85.72|||||Geometric Standard error of mean was calculated.||
1677502|NCT01275170|3086661|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.83|||||2-Sided|90.0|0.63|1.09|||||||
1677449|NCT01276327|3086529|Non-Inferiority or Equivalence|Bioequivalence of the FDC tablet compared with the individual tablets of linagliptin and pioglitazone administered together|Adjusted gMean Ratio (Test/Ref) (%)|99.92|Standard Error of the Mean|1.02|||2-Sided|90.0|97.11|102.81|||||Geometric standard error of mean was calculated.||
1677450|NCT01276314|3086530|Other|||||||0.06||||||This p-value was analyzed for DRESS participants.|Kaplan-Meier analysis|||For evaluating the time taken to heal skin erosion, the Kaplan-Meier product-limit estimates method was performed. Differences were considered statistically significant at P values of less than 0.05.|
1677451|NCT01276314|3086530|Other|||||||0.01||||||The p-value was analyzed for SJS/TEN participants with >10% body surface area detachment.|Kaplan-Meier analysis|||For evaluating the time taken to heal skin erosion, the Kaplan-Meier product-limit estimates method was performed. Differences were considered statistically significant at P values of less than 0.05.|
1677452|NCT01276301|3086540|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.77|Standard Error of the Mean|6.2|||2-Sided|90.0|98.87|106.83|||||Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa|
1677453|NCT01276301|3086541|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|92.39|Standard Error of the Mean|12.7|||2-Sided|90.0|85.38|99.97|||||Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa|
1677454|NCT01276301|3086542|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|102.95|Standard Error of the Mean|6.5|||2-Sided|90.0|98.87|107.02|||||Standard error of the mean is actually the Intra-Individual geometric coefficient of variation (gCV).|Ratio calculated as empa plus verapamil divided by empa|
1677455|NCT01276288|3086545|Non-Inferiority or Equivalence|No formal testing in a confirmatory sense|Geometric mean ratio|102.42|Standard Deviation|5.8|<|0.0001|2-Sided|90.0|97.65|107.42||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M3 divided by TOR-M3"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included|
1677456|NCT01276288|3086545|Non-Inferiority or Equivalence|No formal testing in a confirmatory sense|Geometric mean ratio|102.67|Standard Deviation|10.6|<|0.0012|2-Sided|90.0|94.13|111.97||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M1 divided by TOR-M1"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included|
1677457|NCT01276288|3086545|Non-Inferiority or Equivalence|No formal testing in a confirmatory sense|Geometric mean ratio|104.43|Standard Deviation|13.1|<|0.0066|2-Sided|90.0|93.81|116.25||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR divided by TOR"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included|
1677458|NCT01276288|3086546|Non-Inferiority or Equivalence|No formal testing in a confirmatory sense|Geometric mean ratio|103.19|Standard Deviation|8.9||0.0005|2-Sided|90.0|95.93|111.01||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M3 divided by TOR-M3"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included|
1677459|NCT01276288|3086546|Non-Inferiority or Equivalence|No formal testing in a confirmatory sense|Geometric mean ratio|104.42|Standard Deviation|4.8|<|0.0001|2-Sided|90.0|100.39|108.62||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR-M1 divided by TOR-M1"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included|
1677460|NCT01276288|3086546|Non-Inferiority or Equivalence|No formal testing in a confirmatory sense|Geometric mean ratio|101.44|Standard Deviation|2.9|<|0.0001|2-Sided|90.0|99.06|103.88||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus TOR divided by TOR"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included|
1677461|NCT01276288|3086547|Non-Inferiority or Equivalence|No formal testing in a confirmatory sense|Geometric mean ratio|101.77|Standard Deviation|17.1||0.0114|2-Sided|90.0|88.63|116.85||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ HCT divided by HCT"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included|
1677462|NCT01276288|3086548|Non-Inferiority or Equivalence|No formal testing in a confirmatory sense|Geometric mean ratio|96.27|Standard Deviation|9.6||0.0008|2-Sided|90.0|89.08|104.05||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus HCT divided by HCT"|ANOVA|Model was adjusted for treatment as fixed effect and subject as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included|
1677463|NCT01276288|3086549|Non-Inferiority or Equivalence|No formal testing in a confirmatory sense|Geometric mean ratio|107.5|Standard Deviation|11.3||0.0086|2-Sided|90.0|97.9|118.04||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ TOR divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included|
1677464|NCT01276288|3086549|Non-Inferiority or Equivalence|No formal testing in a confirmatory sense|Geometric mean ratio|102.78|Standard Deviation|18.3||0.0199|2-Sided|90.0|88.55|119.29||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa+ HCT divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included|
1677465|NCT01276288|3086550|Non-Inferiority or Equivalence|No formal testing in a confirmatory sense|Geometric mean ratio|107.83|Standard Deviation|8.9||0.003|2-Sided|90.0|100.14|116.11||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus TOR divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+TOR were included|
1677466|NCT01276288|3086550|Non-Inferiority or Equivalence|No formal testing in a confirmatory sense|Geometric mean ratio|107.08|Standard Deviation|11.8||0.0092|2-Sided|90.0|97.11|118.07||"p-value for ratio outside interval 80-125%~Ratio calculated as Empa plus HCT divided by Empa"|ANOVA|Model was adjusted for sequence, period and treatment as fixed effects while subjects within sequences as random effect|Standard deviation is actually the geometric coefficient of variation (gCV) reflecting intra-subject variabilities|Only patients in sequences Empa/Empa+HCT were included|
1677467|NCT01276106|3086576|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.174||0.2643|2-Sided|95.0|-0.54|0.15||No adjustments for multiple comparisons were made and a value of p<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.|
1677468|NCT01276106|3086576|Superiority or Other||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.176||0.0979|2-Sided|95.0|-0.64|0.05||No adjustments for multiple comparisons were made and a value of p<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.|
1677469|NCT01276106|3086576|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.175||0.044|2-Sided|95.0|-0.7|-0.01||No adjustments for multiple comparisons were made and a value of p<0.05 was considered statistically significant.|ANCOVA|||Change from baseline in HbA1c was analyzed using an analysis of covariance model with change in HbA1c as the dependent variable, treatment as a fixed effect, and baseline HbA1c as a covariate.|
1677470|NCT01275313|3086626|Equivalence|Power calculation: To determine a difference of 20% in the control group and 10% in the treatment group with 80% power, 440 participants would be needed.||||||0.77|||||||Chi-squared, Corrected|||Null hypothesis: At-risk nursing home residents provided with an individually-configured manual lightweight wheelchair and skin protection cushion have the same incidence of pressure injury development compared to individuals using a facility-provided manual wheelchair modified with a skin protection cushion and related adjustments.|
1677471|NCT01275196|3086643|Non-Inferiority or Equivalence|This trial was powered to detect an odds ratio of at least 2.333 which corresponds, for example, to increases of 18% (from 22% to 40%) and increases of 20% (from 30% to 50%).||||||0.0001|||||||Cochran-Mantel-Haenszel||||
1677472|NCT01275170|3086647|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.81|||||2-Sided|90.0|0.37|1.78|||||||
1677473|NCT01275170|3086647|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.91|||||2-Sided|90.0|0.41|2.0|||||||
1677474|NCT01275170|3086647|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.47|||||2-Sided|90.0|0.63|3.4|||||||
1677475|NCT01275170|3086648|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.61|||||2-Sided|90.0|0.36|1.04|||||||
1677476|NCT01275170|3086648|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.6|||||2-Sided|90.0|0.35|1.01|||||||
1677477|NCT01275170|3086648|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.07|||||2-Sided|90.0|0.63|1.83|||||||
1677478|NCT01275170|3086649|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.67|||||2-Sided|90.0|0.47|0.94|||||||
1677479|NCT01275170|3086649|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.63|||||2-Sided|90.0|0.45|0.9|||||||
1677480|NCT01275170|3086649|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.52|||||2-Sided|90.0|1.07|2.15|||||||
1677481|NCT01275170|3086655|Other|GMR (Renal Impairment/Healthy Control)|GMR|2.81|||||2-Sided|90.0|2.16|3.65|||||||
1677482|NCT01275170|3086655|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.76|||||2-Sided|90.0|0.59|0.97|||||||
1677483|NCT01275170|3086655|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||2-Sided|90.0|0.62|1.03|||||||
1677484|NCT01275170|3086655|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.91|||||2-Sided|90.0|0.71|1.17|||||||
1677485|NCT01275170|3086655|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.8|||||2-Sided|90.0|0.62|1.04|||||||
1677486|NCT01275170|3086656|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.27|||||2-Sided|90.0|0.18|0.43|||||||
1677487|NCT01275170|3086656|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.07|||||2-Sided|90.0|0.05|0.11|||||||
1677488|NCT01275170|3086656|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.18|||||2-Sided|90.0|0.12|0.27|||||||
1677489|NCT01275170|3086656|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.54|||||2-Sided|90.0|0.35|0.83|||||||
1677490|NCT01275170|3086656|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.63|||||2-Sided|90.0|0.4|0.97|||||||
1677491|NCT01275170|3086657|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.94|||||2-Sided|90.0|0.57|1.54|||||||
1677492|NCT01275170|3086657|Other|GMR (Renal Impairment/Healthy Control)|GMR|2.49|||||2-Sided|90.0|1.51|4.09|||||||
1677493|NCT01275170|3086657|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.49|||||2-Sided|90.0|0.9|2.44|||||||
1677494|NCT01275170|3086657|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.13|||||2-Sided|90.0|0.69|1.87|||||||
1677495|NCT01275170|3086657|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.25|||||2-Sided|90.0|0.75|2.08|||||||
1677496|NCT01275170|3086658|Other|GMR (Renal Impairment/Healthy Control)|GMR|3.64|||||2-Sided|90.0|2.32|5.69|||||||
1677497|NCT01275170|3086658|Other|GMR (Renal Impairment/Healthy Control)|GMR|13.75|||||2-Sided|90.0|8.96|21.12|||||||
1677498|NCT01275170|3086658|Other|GMR (Renal Impairment/Healthy Control)|GMR|5.6|||||2-Sided|90.0|3.64|8.59|||||||
1677499|NCT01275170|3086658|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.86|||||2-Sided|90.0|1.21|2.87|||||||
1677500|NCT01275170|3086658|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.6|||||2-Sided|90.0|1.03|2.49|||||||
1677501|NCT01275170|3086661|Other|GMR (Renal Impairment/Healthy Control)|GMR|2.54|||||2-Sided|90.0|1.93|3.36|||||||
1677505|NCT01275170|3086661|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.81|||||2-Sided|90.0|0.61|1.08|||||||
1677506|NCT01275170|3086662|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.01|||||2-Sided|90.0|0.78|1.31|||||||
1677507|NCT01275170|3086662|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.32|||||2-Sided|90.0|0.25|0.42|||||||
1677508|NCT01275170|3086662|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.4|||||2-Sided|90.0|0.31|0.52|||||||
1677509|NCT01275170|3086662|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.65|||||2-Sided|90.0|0.5|0.85|||||||
1677510|NCT01275170|3086662|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.71|||||2-Sided|90.0|0.54|0.93|||||||
1677511|NCT01275170|3086663|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.86|||||2-Sided|90.0|0.49|1.51|||||||
1677512|NCT01275170|3086663|Other|GMR (Renal Impairment/Healthy Control)|GMR|2.46|||||2-Sided|90.0|1.4|4.33|||||||
1677513|NCT01275170|3086663|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.32|||||2-Sided|90.0|0.75|2.32|||||||
1677514|NCT01275170|3086663|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.07|||||2-Sided|90.0|0.61|1.89|||||||
1677515|NCT01275170|3086663|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.15|||||2-Sided|90.0|0.65|2.06|||||||
1677516|NCT01275170|3086664|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.99|||||2-Sided|90.0|0.76|1.29|||||||
1677517|NCT01275170|3086664|Other|GMR (Renal Impairment/Healthy Control)|GMR|3.1|||||2-Sided|90.0|2.39|4.03|||||||
1677518|NCT01275170|3086664|Other|GMR (Renal Impairment/Healthy Control)|GMR|2.51|||||2-Sided|90.0|1.93|3.26|||||||
1677519|NCT01275170|3086664|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.53|||||2-Sided|90.0|1.17|1.99|||||||
1677520|NCT01275170|3086664|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.41|||||2-Sided|90.0|1.07|1.84|||||||
1677521|NCT01275170|3086667|Other|GMR (Renal Impairment/Healthy Control)|GMR|3.28|||||2-Sided|90.0|2.7|4.0|||||||
1677522|NCT01275170|3086667|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.96|||||2-Sided|90.0|0.79|1.16|||||||
1677523|NCT01275170|3086667|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.9|||||2-Sided|90.0|0.74|1.08|||||||
1677524|NCT01275170|3086667|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.01|||||2-Sided|90.0|0.84|1.22|||||||
1677525|NCT01275170|3086667|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.99|||||2-Sided|90.0|0.82|1.21|||||||
1677526|NCT01275170|3086668|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.57|||||2-Sided|90.0|0.39|0.84|||||||
1677527|NCT01275170|3086668|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.11|||||2-Sided|90.0|0.07|0.16|||||||
1677528|NCT01275170|3086668|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.21|||||2-Sided|90.0|0.14|0.3|||||||
1677529|NCT01275170|3086668|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.46|||||2-Sided|90.0|0.31|0.66|||||||
1677530|NCT01275170|3086668|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.61|||||2-Sided|90.0|0.42|0.9|||||||
1677531|NCT01275170|3086669|Other|GMR (Renal Impairment/Healthy Control)|GMR|0.85|||||2-Sided|90.0|0.5|1.44|||||||
1677532|NCT01275170|3086669|Other|GMR (Renal Impairment/Healthy Control)|GMR|2.34|||||2-Sided|90.0|1.39|3.96|||||||
1677533|NCT01275170|3086669|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.3|||||2-Sided|90.0|0.77|2.2|||||||
1677534|NCT01275170|3086669|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.04|||||2-Sided|90.0|0.62|1.77|||||||
1677535|NCT01275170|3086669|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.1|||||2-Sided|90.0|0.64|1.88|||||||
1677536|NCT01275170|3086670|Other|GMR (Renal Impairment/Healthy Control)|GMR|1.76|||||2-Sided|90.0|1.2|2.58|||||||
1677537|NCT01275170|3086670|Other|GMR (Renal Impairment/Healthy Control)|GMR|9.32|||||2-Sided|90.0|6.45|13.46|||||||
1677538|NCT01275170|3086670|Other|GMR (Renal Impairment/Healthy Control)|GMR|4.87|||||2-Sided|90.0|3.37|7.04|||||||
1677539|NCT01275170|3086670|Other|GMR (Renal Impairment/Healthy Control)|GMR|2.19|||||2-Sided|90.0|1.51|3.18|||||||
1677540|NCT01275170|3086670|Other|Geometric mean ratio (GMR) [Renal Impairment/Healthy Control]|GMR|1.63|||||2-Sided|90.0|1.12|2.39|||||||
1677541|NCT01275144|3086692|Superiority or Other||Ratio of geometric least square mean|1.04|||||2-Sided|90.0|1.01|1.08|||||Ratio of LY2216684 to Placebo||
1677542|NCT01275144|3086693|Superiority or Other||median of paired differences|0.5||||0.0021|2-Sided|90.0|0.5|1.0|||Wilcoxon signed rank test||Ratio of LY2216684 to Placebo||
1677543|NCT01275144|3086694|Superiority or Other||Ratio of geometric least square mean|0.897|||||2-Sided|90.0|0.86|0.94|||||Ratio of LY2216684 to Placebo||
1677544|NCT01275131|3086706|Superiority or Other||Least Squares Mean Difference|5.32||||0.0552|2-Sided|90.0|0.77|9.88|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 5/10|
1677545|NCT01275131|3086706|Superiority or Other||Least Squares Mean Difference|14.1|||<|0.0001|2-Sided|90.0|9.55|18.65|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 3/8|
1677546|NCT01275131|3086706|Superiority or Other||Least Squares Mean Difference|16.41|||<|0.0001|2-Sided|90.0|11.86|20.97|||Mixed Models Analysis|Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.||Comparison at Stage 3, Day 2/7|
1677547|NCT01275131|3086708|Superiority or Other||Least Squares Mean Difference|18.14|||<|0.0001|2-Sided|90.0|11.55|24.72|||Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||Comparison at Stage 1, Day 4/8|
1677548|NCT01275131|3086708|Superiority or Other||Least Squares Mean Difference|13.95|||<|0.0009|2-Sided|90.0|7.37|20.54|||Mixed Models Analysis|A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.||Comparison at Stage 1, Day 2/6|
1677577|NCT01273155|3086819|Other|M24/M26|Kendall's Tau|-0.309||||0.001|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677549|NCT01275066|3086712|Superiority or Other||Mean Difference (Final Values)|-30.2|Standard Error of the Mean|4.19|<|0.0001||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p<0.05 or either of p-values is p<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline uKS normalized for creatinine, as covariates.|||
1677550|NCT01275066|3086712|Superiority or Other||Mean Difference (Final Values)|-40.7|Standard Error of the Mean|4.2|<|0.0001||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p<0.05 or either of p-values is p<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline uKS normalized for creatinine, as covariates.|||
1677551|NCT01275066|3086713|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|1.66||0.7783||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p<0.05 or either of p-values is p<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline 3MSCT as covariates.|||
1677552|NCT01275066|3086713|Superiority or Other||Mean Difference (Final Values)|1.1|Standard Error of the Mean|1.66||0.4935||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p<0.05 or either of p-values is p<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category, and baseline 3MSCT as covariates.|||
1677553|NCT01275066|3086714|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|9.29||0.9542||||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p<0.05 or either of p-values is p<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category as covariates.|||
1677554|NCT01275066|3086714|Superiority or Other||Mean Difference (Final Values)|22.5|Standard Error of the Mean|9.35||0.0174||95.0||||Hochberg multiplicity adjustment - results considered statistically significant if both of p-values are p<0.05 or either of p-values is p<0.025.|ANCOVA|ANCOVA of change from baseline with treatment, age group, baseline 6MWT category as covariates.|||
1677555|NCT01274897|3086719|Superiority or Other||Lower limit of the two-sided 95% CI|63.0|||||2-Sided|95.0|63.0|74.0|||||For serogroup Y|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is < 50%.|
1677556|NCT01274897|3086719|Superiority or Other||Lower limit of the two-sided 95% CI|23.0|||||2-Sided|95.0|23.0|33.0|||||For the serogroup W|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is < 50%.|
1677557|NCT01274897|3086719|Superiority or Other||Lower limit of the two-sided 95% CI|82.0|||||2-Sided|95.0|82.0|90.0|||||For the serogroup C|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is < 50%.|
1677558|NCT01274897|3086719|Superiority or Other||Lower limit of the two-sided 95% CI|71.0|||||2-Sided|95.0|71.0|81.0|||||For serogroup A.|The null hypothesis associated with the primary immunogenicity objective is that for at least one of the four serogroups, the percentage of subjects with hSBA seroresponse at 29 days postvaccination is < 50%.|
1677559|NCT01274611|3086728|Non-Inferiority or Equivalence|A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.|Mean Difference (Net)|15.0|||>|0.01|||||||t-test, 2 sided||||
1677560|NCT01274611|3086729|Non-Inferiority or Equivalence|A sample of 20 patients, or 40 treatment sites (the unit of randomization), provided 80% power to detect effect sizes of 0.68 using a paired t test at a type I error rate of 5%.|Mean Difference (Net)|0.8|||<|0.01|||||||t-test, 2 sided||||
1677561|NCT01274182|3086764|Non-Inferiority|The predefined noninferiority margin of 0.15 for ACR20 is based on the historical placebo-controlled phase III study to evaluate the response rate benefit of adding rituximab to the conventional small molecule-based treatment of patients with RA (Cohen et al. 2006).|Response rate difference (%)|-0.57|Standard Error of the Mean|7.23|||2-Sided|95.0|-14.74|13.6|||||The direction of comparison is response rate of GP2013 Part I - response rate of MabThera|To conclude non-inferiority the lower 95% CI should be greater than -15.0%.|
1677562|NCT01274182|3086764|Non-Inferiority|The predefined noninferiority margin of 0.15 for ACR20 is based on the historical placebo-controlled phase III study to evaluate the response rate benefit of adding rituximab to the conventional small molecule-based treatment of patients with RA (Cohen et al. 2006).|Response rate difference (%)|9.77|Standard Error of the Mean|6.79|||2-Sided|95.0|-3.54|23.08|||||The direction of comparison is response rate of GP2013 - response rate of Rituxan|To conclude non-inferiority the lower 95% CI should be greater than -15.0%.|
1677563|NCT01274182|3086765|Non-Inferiority|"The non-inferiority margin is further justified by the EULAR criteria which define “no response” as change from baseline being < 0.6. LS means, standard errors and 95% CI were estimated by a repeated measures mixed model with treatment, time and treatment*time interaction term as categorical variables and baseline DAS28 as a continuous variable.~A negative change from baseline represents an improvement in assessment of rheumatoid arthritis."|LS Mean difference|0.07|Standard Error of the Mean|0.201|||2-Sided|95.0|-0.328|0.462|||||The direction of comparison is LS mean of GP2013 Part I - LS mean of MabThera|To conclude non-inferiority the upper 95% CI should be less than or equal to 0.6. This margin was statistically justified by the results of the REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) trial (Cohen et al 2006) providing a 95% CI for the mean difference between rituximab/MTX and MTX alone of (-1.74;-1.25). The margin of 0.6 was determined by retaining more than 50% of the reference treatment effect which was considered clinically acceptable.|
1677574|NCT01273818|3086776|Superiority or Other|||||||0.198|||||||Fisher Exact|||Comparison Group Selection: our primary outcome is “infection positive or negative”so, we compared the frequencies of being positive infections for these three groups. Our null hypothesis is “ positive infection frequencies are same for three groups”. We calculated post-hoc power for this design and found 0.99 for the percentages which shows positive infections respectively for Topical Gentamicin, cefazoline iv and topical gentamicin and iv cefazolin; 2.3%, 3.1% and 0%.|
1677575|NCT01273623|3086789|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1677622|NCT01272908|3086856|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24|
1677564|NCT01274182|3086765|Non-Inferiority|"The non-inferiority margin is further justified by the EULAR criteria which define “no response” as change from baseline being < 0.6.~LS means, standard errors and 95% CI were estimated by a repeated measures mixed model with treatment, time and treatment*time interaction term as categorical variables and baseline DAS28 as a continuous variable.~A negative change from baseline represents an improvement in assessment of rheumatoid arthritis."|LS Mean difference|-0.08|Standard Error of the Mean|0.162|||2-Sided|95.0|-0.397|0.24|||||The direction of comparison is LS mean of GP2013 - LS mean of Rituxan|To conclude non-inferiority the upper 95% CI should be less than or equal to 0.6. This margin was statistically justified by the results of the REFLEX (Randomized Evaluation of Long-Term Efficacy of Rituximab in RA) trial (Cohen et al 2006) providing a 95% CI for the mean difference between rituximab/MTX and MTX alone of (-1.74;-1.25). The margin of 0.6 was determined by retaining more than 50% of the reference treatment effect which was considered clinically acceptable.|
1677565|NCT01274182|3086766|Equivalence|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|1.033|||||2-Sided|95.0|1.016|1.05|||||Rituxan arm is the numerator and MabThera arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalence limits of 0.8-1.25|
1677566|NCT01274182|3086766|Equivalence|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|1.021|||||2-Sided|95.0|1.003|1.04|||||GP2013 arm is the numerator and MabThera arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalencelimits of 0.8-1.25|
1677567|NCT01274182|3086766|Equivalence|Ratio of geometric means and 95% confidence interval were estimated by an analysis of variance (ANOVA) on log-transformed PD parameter with treatment as the factor. Results were then back-transformed to the original scale.|Geometric mean ratio|0.989|||||2-Sided|95.0|0.974|1.004|||||GP2013 arm is the numerator and Rituxan arm is the denominator|To conclude equivalence the 95% CI must be entirely within the standard equivalencelimits of 0.8-1.25|
1677568|NCT01274182|3086767|Equivalence|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.05|||||2-Sided|90.0|0.946|1.167|||||Rituxan arm is the numerator and MabThera arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25.|
1677569|NCT01274182|3086767|Equivalence|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.131|||||2-Sided|90.0|1.027|1.244|||||GP2013 arm is the numerator and MabThera arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25|
1677570|NCT01274182|3086767|Equivalence|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.076|||||2-Sided|90.0|0.979|1.184|||||GP2013 arm is the numerator and Rituxan arm is the denominator|To conclude bioequivalence the 90% CI must be entirely within the standard equivalence limits of 0.8-1.25.|
1677571|NCT01274182|3086768|Equivalence|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.093|||||2-Sided|90.0|0.989|1.208|||||Rituxan arm is the numerator and MabThera arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.|
1677572|NCT01274182|3086768|Equivalence|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.012|||||2-Sided|90.0|0.925|1.108|||||GP2013 arm is the numerator and Rituxan arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.|
1677573|NCT01274182|3086768|Equivalence|The PK parameters were transformed prior to analysis using a logarithmic transformation. An analysis of variance (ANOVA) was used to analyze the transformed data including treatment group only as a factor in the model. The confidence interval for the difference between the two products on the transformed scale was obtained from the ANOVA model, which was then be back-transformed (exp base e) to obtain the confidence interval for the ratio on the original scale.|Geometric mean ratio|1.106|||||2-Sided|90.0|1.01|1.21|||||GP2013 arm is the numerator and MabThera arm is the denominator|PK bioequivalence is defined as AUC(0-inf) of the drugs being comparable, i.e. the two-sided 90% CI for the ratio of the geometric means (GP2013/MabThera) is within the predefined bioequivalence limits of 0.8 to 1.25.|
1677576|NCT01273155|3086819|Other|M26/M21|Kendall's Tau|-0.205||||0.032|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677578|NCT01273155|3086819|Other|M26/belinostat|Kendall's Tau|0.218||||0.033|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677579|NCT01273155|3086819|Other|M24/belinostat|Kendall's Tau|-0.205||||0.037|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677580|NCT01273155|3086819|Other|M21/belinostat|Kendall's Tau|0.315||||0.001|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677581|NCT01273155|3086819|Other|Methyl belinostat/belinostat|Kendall's Tau|0.38|||<|0.001|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677582|NCT01273155|3086819|Other|Belinostat glucuronide/belinostat|Kendall's Tau|-0.055|||<|0.568|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677583|NCT01273155|3086820|Other|M26/M21|Kendall's Tau|-0.159||||0.095|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677584|NCT01273155|3086820|Other|M24/M26|Kendall's Tau|-0.308||||0.002|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677585|NCT01273155|3086820|Other|M26/belinostat|Kendall's Tau|0.127||||0.275|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677586|NCT01273155|3086820|Other|M24/belinostat|Kendall's Tau|-0.24||||0.037|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677587|NCT01273155|3086820|Other|M21/belinostat|Kendall's Tau|0.335||||0.004|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677588|NCT01273155|3086820|Other|Methyl belinostat/belinostat|Kendall's Tau|0.295||||0.011|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677589|NCT01273155|3086820|Other|Belinostat glucuronide/belinostat|Kendall's Tau|-0.224||||0.023|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677590|NCT01273155|3086821|Other||Kendall's Tau|0.06||||0.531|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677591|NCT01273155|3086822|Other||Kendall's Tau|-0.216||||0.023|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677592|NCT01273155|3086823|Other|M26|Kendall's Tau|0.22||||0.021|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677593|NCT01273155|3086823|Other|M24|Kendall's Tau|-0.114||||0.231|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677594|NCT01273155|3086823|Other|M21|Kendall's Tau|0.242||||0.011|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677595|NCT01273155|3086823|Other|Methyl belinostat|Kendall's Tau|0.268||||0.005|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677596|NCT01273155|3086823|Other|Belinostat glucuronide|Kendall's Tau|-0.216||||0.023|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677597|NCT01273155|3086823|Other|Belinostat|Kendall's Tau|0.091||||0.34|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677598|NCT01273155|3086824|Other||Kendall's Tau|0.057||||0.548|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677623|NCT01272908|3086858|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24|
1677599|NCT01273155|3086825|Other|M26|Kendall's Tau|0.246||||0.01|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677600|NCT01273155|3086825|Other|M24|Kendall's Tau|-0.061||||0.524|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677601|NCT01273155|3086825|Other|M21|Kendall's Tau|0.337|||<|0.001|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677602|NCT01273155|3086825|Other|Methyl belinostat|Kendall's Tau|0.426|||<|0.001|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677603|NCT01273155|3086825|Other|Belinostat|Kendall's Tau|0.215|||<|0.025|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677604|NCT01273155|3086826|Other|M26|Kendall's Tau|0.098||||0.312|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677605|NCT01273155|3086826|Other|M24|Kendall's Tau|-0.278||||0.004|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677606|NCT01273155|3086826|Other|M21|Kendall's Tau|0.253||||0.009|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677607|NCT01273155|3086826|Other|Methyl belinostat|Kendall's Tau|0.382|||<|0.001|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677608|NCT01273155|3086826|Other|Belinostat glucuronide|Kendall's Tau|-0.178|||<|0.063|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677609|NCT01273155|3086826|Other|Belinostat|Kendall's Tau|0.096|||<|0.327|2-Sided||||||Jonckheere-Terpstra|||Effects of liver dysfunction on PK parameter values were evaluated with SPSS 22.0 for Windows (SPSS Inc., Chicago, IL), using the Jonckheere-Terpstra and Kendall's Tau test. Data were considered significantly different when p<0.05.|
1677610|NCT01272921|3086841|Superiority or Other||Mean Difference (Final Values)|-6.0|Standard Deviation|0.0||0.05|2-Sided|95.0|-7.0|-2.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.|
1677611|NCT01272921|3086841|Superiority or Other||Mean Difference (Final Values)|-7.0|Standard Deviation|0.0||0.05|2-Sided|95.0|-10.0|-4.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.|
1677612|NCT01272921|3086841|Superiority or Other||Mean Difference (Final Values)|-11.0|Standard Deviation|0.0||0.05|2-Sided|95.0|-15.0|-6.0|||Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.|
1677613|NCT01272921|3086841|Superiority or Other||Mean Difference (Final Values)|-11.0|Standard Deviation|0.0||0.05|2-Sided|95.0|-17.0|-6.0||Post hoc comparison were made against the 30-mL volume group and corrected for 6 comparisons using the Wilcoxon rank sum test.|Wilcoxon (Mann-Whitney)|||The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference.|
1677614|NCT01272921|3086842|Superiority or Other||Mean Difference (Final Values)|0.19|||<|0.001|2-Sided|95.0|0.18|0.21|||Z score||||
1677615|NCT01272921|3086842|Superiority or Other||Mean Difference (Final Values)|0.52|||<|0.001|2-Sided|95.0|0.49|0.54|||Z score||||
1677616|NCT01272908|3086844|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24|
1677617|NCT01272908|3086844|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 12|
1677618|NCT01272908|3086848|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24|
1677619|NCT01272908|3086850|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24|
1677620|NCT01272908|3086852|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test|||Baseline vs Week 24|
1677621|NCT01272908|3086854|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24|
1677624|NCT01272908|3086860|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||Baseline vs Week 24|
1677625|NCT01272908|3086862|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed-Rank test|||Baseline vs Week 24|
1677626|NCT01272908|3086864|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||Week 48|
1677627|NCT01272908|3086864|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||Week 36|
1677628|NCT01272908|3086864|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||Week 24|
1677629|NCT01272908|3086864|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||Week 12|
1677630|NCT01272908|3086864|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||Week 4|
1677631|NCT01272908|3086866|Superiority or Other||Odds Ratio (OR)|3.009||||0.012|||||||Regression, Logistic|||Good/Moderate vs None: Week 24 vs Week 4|
1677632|NCT01272908|3086866|Superiority or Other||Odds Ratio (OR)|2.138||||0.44|||||||Regression, Logistic|||Good/Moderate vs None: Week 12 vs Week 4|
1677633|NCT01272908|3086866|Superiority or Other||Odds Ratio (OR)|3.589|||<|0.001|||||||Regression, Logistic|||Good vs Moderate vs None: Week 24 vs Week 4|
1677634|NCT01272908|3086866|Superiority or Other||Odds Ratio (OR)|2.099|||<|0.667|||||||Regression, Logistic|||Good vs Moderate vs None: Week 12 vs Week 4|
1677635|NCT01272908|3086870|Superiority or Other||Odds Ratio (OR)|6.861||||0.001|||||||Regression, Logistic|||ACR50: Week 24 vs. Week 4|
1677636|NCT01272908|3086870|Superiority or Other||Odds Ratio (OR)|5.552||||0.023|||||||Regression, Logistic|||ACR50: Week 12 vs Week 4|
1677637|NCT01272908|3086870|Superiority or Other||Odds Ratio (OR)|3.019||||0.005|||||||Regression, Logistic|||ACR20: Week 24 vs Week 4|
1677638|NCT01272908|3086870|Superiority or Other||Odds Ratio (OR)|2.293||||0.253|||||||Regression, Logistic|||ACR20: Week 12 versus (vs) Week 4|
1677639|NCT01272830|3086875|Superiority||||||>|0.05|||||||paired t-test|Significant threshold p<0.05||Changes from baseline data|
1677640|NCT01272830|3086875|Superiority||||||>|0.01||||||Significance threshold p<0.05|ANOVA|||Change from baseline data|
1677641|NCT01272830|3086876|Superiority||||||>|0.05||||||Significant threshold p<0.05|paired t-test|||Change from baseline data|
1677642|NCT01272830|3086876|Superiority||||||>|0.0083||||||Significance threshold p<0.05|t-test|||Changes from baseline data|
1677643|NCT01272830|3086877|Superiority|||||||0.1578|||||||paired t-test|||Change from baseline data (KSS knee pain)|
1677644|NCT01272830|3086877|Superiority|||||||0.1312|||||||paired t-test|||Change from baseline data (HSS total score)|
1677645|NCT01272830|3086877|Superiority|||||||0.2137|||||||paired t-test|||Changes from baseline data (HSS pain walking)|
1677646|NCT01272830|3086877|Superiority|||||||0.0391||||||Significance threshold p<0.05|paired t-test|||Change from baseline data (KSS knee pain)|
1677647|NCT01272830|3086877|Superiority|||||||0.0375||||||Significance threshold P<0.05|paired t-test|||Change from baseline data (HSS total score)|
1677648|NCT01272830|3086877|Superiority|||||||0.0226||||||Significance threshold p<0.5|paired|||Change from baseline data (HSS pain walking)|
1677649|NCT01272830|3086878|Superiority||||||>|0.05||||||Significant threshold p<0.05|paired t-test|||Changes from baseline data|
1677650|NCT01272830|3086878|Superiority||||||>|0.0063||||||Significance threshold p<0.05|paired t-test|||Change from baseline data.|
1677651|NCT01272635|3086917|Superiority or Other||Hazard Ratio (HR)|0.64||||0.04|2-Sided|95.0|0.41|0.98|||Discrete time survival analysis||Hazard ratio: Numerator is Azithromycin and Denominator is Placebo||
1677652|NCT01272583|3086919|Superiority or Other|||||||0.76|||||||ANOVA|The Friedman Test was used for ANOVA.|||
1677653|NCT01272583|3086920|Superiority or Other||||||<|0.05|||||||Dunn's Multiple Comparison Test|Post Hoc testing|||
1677654|NCT01272583|3086920|Superiority or Other||||||<|0.01|||||||ANOVA|The Friedman Test was used for ANOVA.|||
1677655|NCT01272583|3086921|Superiority or Other|||||||0.22|||||||ANOVA|The Friedman Test was used for ANOVA.|||
1677656|NCT01272583|3086922|Superiority or Other|||||||0.98|||||||ANOVA|The Friedman Test was used for ANOVA.|||
1677657|NCT01272583|3086923|Superiority or Other|||||||0.14|||||||ANOVA|The Friedman Test was used for ANOVA.|||
1677658|NCT01272583|3086924|Superiority or Other|||||||0.44||||||GIP total|ANOVA|The Friedman Test was used for ANOVA|||
1677659|NCT01272583|3086924|Superiority or Other|||||||0.049||||||GIP intact|ANOVA|The Friedman Test was used for ANOVA.|||
1677660|NCT01272583|3086924|Superiority or Other|||||||0.98||||||GLP-1 Total|ANOVA|The Friedman Test was used for ANOVA.|||
1677661|NCT01272583|3086924|Superiority or Other||||||<|0.001||||||GLP-1 intact|ANOVA|The Friedman Test was used for ANOVA|||
1677662|NCT01272583|3086925|Superiority or Other|||||||1|||||||ANOVA|The Friedman Test was used for ANOVA.|||
1677663|NCT01272284|3086938|Superiority or Other||Proportion successful|85.4|||<|0.0001|1-Sided|95.81|78.1||||Fisher Exact|||The final significance level is 0.04191 accounting for one interim analysis conducted at 80% of final information, thus a 95.81% Confidence Limit (CL) was used.|
1677664|NCT01272232|3086946|Superiority or Other||Treatment contrast|-1.02||||0.0961||95.0|-2.22|0.18||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677665|NCT01272232|3086946|Superiority or Other||Treatment contrast|-1.47||||0.0457||95.0|-2.92|-0.03||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677666|NCT01272232|3086946|Superiority or Other||Treatment contrast|-2.49|||<|0.0001||95.0|-3.75|-1.24||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677667|NCT01272232|3086948|Superiority or Other||Treatment contrast|-0.97||||0.0717||95.0|-2.02|0.09||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677668|NCT01272232|3086948|Superiority or Other||Treatment contrast|-1.2||||0.0725||95.0|-2.51|0.11||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677669|NCT01272232|3086948|Superiority or Other||Treatment contrast|-2.17||||0.0002||95.0|-3.32|-1.02||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677670|NCT01272232|3086949|Superiority or Other||Treatment contrast|-1.16||||0.0224||95.0|-2.16|-0.16||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677671|NCT01272232|3086949|Superiority or Other||Treatment contrast|-2.06||||0.0004||95.0|-3.2|-0.92||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677672|NCT01272232|3086949|Superiority or Other||Treatment contrast|-3.22|||<|0.0001||95.0|-4.2|-2.23||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677673|NCT01272232|3086950|Superiority or Other||Odds Ratio (OR)|1.61||||0.0142||95.0|1.1|2.34||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677674|NCT01272232|3086950|Superiority or Other||Odds Ratio (OR)|5.98|||<|0.0001||95.0|3.59|9.97||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677675|NCT01272232|3086950|Superiority or Other||Odds Ratio (OR)|9.61|||<|0.0001||95.0|6.05|15.26||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677676|NCT01272232|3086951|Superiority or Other||Odds Ratio (OR)|1.14||||0.5319||95.0|0.76|1.71||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677677|NCT01272232|3086951|Superiority or Other||Odds Ratio (OR)|7.71|||<|0.0001||95.0|4.76|12.51||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677678|NCT01272232|3086951|Superiority or Other||Odds Ratio (OR)|8.79|||<|0.0001||95.0|5.74|13.4||p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677679|NCT01272232|3086952|Superiority or Other||Treatment contrast|-0.19||||0.0125||95.0|-0.34|-0.04||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677680|NCT01272232|3086952|Superiority or Other||Treatment contrast|-0.74|||<|0.0001||95.0|-0.91|-0.57||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677681|NCT01272232|3086952|Superiority or Other||Treatment contrast|-0.93|||<|0.0001||95.0|-1.08|-0.78||p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677682|NCT01272232|3086953|Superiority or Other||Odds Ratio (OR)|1.85||||0.0099||95.0|1.16|2.95||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677683|NCT01272232|3086953|Superiority or Other||Odds Ratio (OR)|3.84||||0.0008||95.0|1.75|8.41||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677684|NCT01272232|3086953|Superiority or Other||Odds Ratio (OR)|7.1|||<|0.0001||95.0|3.48|14.48||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677685|NCT01272232|3086954|Superiority or Other||Odds Ratio (OR)|1.84||||0.0008||95.0|1.29|2.64||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677686|NCT01272232|3086954|Superiority or Other||Odds Ratio (OR)|3.69|||<|0.0001||95.0|2.24|6.09||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677687|NCT01272232|3086954|Superiority or Other||Odds Ratio (OR)|6.81|||<|0.0001||95.0|4.34|10.68||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|Regression, Logistic|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677688|NCT01272232|3086955|Superiority or Other||Treatment contrast|-1.35||||0.0024||95.0|-2.23|-0.48||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677689|NCT01272232|3086955|Superiority or Other||Treatment contrast|-2.62|||<|0.0001||95.0|-3.63|-1.62||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677690|NCT01272232|3086955|Superiority or Other||Treatment contrast|-3.97|||<|0.0001||95.0|-4.84|-3.11||Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.|ANCOVA|||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.|
1677691|NCT01272219|3086964|Superiority or Other||Treatment estimate|2.681|||<|0.0001|2-Sided|95.0|1.856|3.872|||Weibull analysis||The treatment estimate was the factor that the time to event is multiplied with for liraglutide 3.0 mg compared to placebo.|If the estimated time-to-event ratio (liraglutide 3.0 mg/ placebo), as assessed by the survival endpoint describing the time until onset of T2DM (‘diabetes-free time’), is statistically significantly >1, then liraglutide 3.0 mg was to be considered superior to placebo in delaying the onset of T2DM in subjects with pre-diabetes at baseline. Weibull model was used; included treatment, sex and BMI stratification factor as fixed factors and baseline FPG as a covariate.|
1677692|NCT01272219|3086965|Superiority or Other||Odds Ratio (OR)|4.34|||<|0.0001|2-Sided|95.0|3.54|5.32|||Regression, Logistic||The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing >10% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.|
1677693|NCT01272219|3086966|Superiority or Other||Odds Ratio (OR)|4.8|||<|0.0001|2-Sided|95.0|4.12|5.6|||Regression, Logistic||The model included treatment, country, sex, pre-diabetes status at screening, BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss as assessed by the proportion of subjects losing ≥5% of their fasting baseline weight, if the estimated odds ratio (liraglutide 3.0 mg/liraglutide placebo) was statistically significantly greater than one.|
1677694|NCT01272219|3086967|Superiority or Other||Estimated mean difference|-5.39|||<|0.0001|2-Sided|95.0|-5.82|-4.95|||ANCOVA||ANCOVA model with treatment, country, sex, pre-diabetes status at screening, baseline BMI stratum and an interaction between pre-diabetes status at screening and BMI stratum as fixed factors, and the baseline value as covariate.|Null-hypothesis: no treatment difference between treatment arms, i.e. liraglutide 3.0 mg and liraglutide placebo. Liraglutide 3.0 mg was considered superior to placebo in inducing and maintaining weight loss, if the estimated treatment effect (liraglutide 3.0 mg – liraglutide placebo) was statistically significantly smaller than zero.|
1677695|NCT01272180|3086983|Non-Inferiority or Equivalence|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days.|Group Difference % (ABCWY+qOMV - ACWY)|15.0|||||2-Sided|95.0|3.0|29.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.|
1677696|NCT01272180|3086983|Non-Inferiority or Equivalence|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|19.0|||||2-Sided|95.0|4.0|33.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.|
1677716|NCT01271933|3087018|Superiority or Other||Odds Ratio (OR)|1.29||||0.4691|2-Sided|95.0|0.64|2.61||Nominal p-value for two-sided test|two-sided test|||This analysis is for the domain: Satisfaction from treatment|
1677717|NCT01271933|3087018|Superiority or Other||Odds Ratio (OR)|2.29||||0.0296|2-Sided|95.0|1.09|4.81||Nominal p-value for two-sided test.|two-sided test|||This analysis is for the domain: Benefit from treatment|
1679462|NCT01256385|3089231|Superiority or Other|||||||0.87|||||||Log Rank||||
1677697|NCT01272180|3086983|Non-Inferiority or Equivalence|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of MenACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|30.0|||||2-Sided|95.0|18.0|42.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.|
1677698|NCT01272180|3086983|Non-Inferiority or Equivalence|The immune response of MenABCWY+qOMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+qOMV - ACWY)|18.0|||||2-Sided|95.0|7.0|30.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.|
1677699|NCT01272180|3086983|Non-Inferiority or Equivalence|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|18.0|||||2-Sided|95.0|5.0|31.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses MenABCWY combination vaccine to that of one dose of MenACWY vaccine.|
1677700|NCT01272180|3086983|Non-Inferiority or Equivalence|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|15.0|||||2-Sided|95.0|0.0|30.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.|
1677701|NCT01272180|3086983|Non-Inferiority or Equivalence|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between MenABCWY and MenACWY groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|32.0|||||2-Sided|95.0|21.0|44.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.|
1677702|NCT01272180|3086983|Non-Inferiority or Equivalence|The immune response of ABCWY+OMV group was considered to be non-inferior to that of ACWY group if the lower limit of the two-sided 95% confidence interval on the difference between groups in percentage of subjects with seroresponse is greater than -10% for each of A, C, W-135and Y serogroups, at 30 days after the last vaccination.|Group Difference % (ABCWY+OMV - ACWY)|16.0|||||2-Sided|95.0|5.0|29.0||||||Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine.|
1677703|NCT01272011|3086987|Superiority or Other||||||<|0.05|||||||RMANOVA and Student-Neuman-Keuls|||Compared outcomes from Baseline versus Post-Day 10 IH for mean slope of of Pressure vs. Resistance|
1677704|NCT01272011|3086987|Superiority or Other||||||<|0.05|||||||RMANOVA and Student-Neuman-Keuls|||Compared outcomes from Baseline versus Post-Day 10 IH for mean slope of AF vs. Resistance|
1677705|NCT01272011|3086988|Superiority or Other||||||<|0.001|||||||Two-way RMANOVA Student-Newman-Keuls|||Daily acute and cumulative Pre vs Post comparisons|
1677706|NCT01271933|3087001|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|1.38||0.6647|2-Sided|95.0|-2.2|3.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA||||
1677707|NCT01271933|3087002|Superiority or Other||Mean Difference (Final Values)|6489.5|Standard Error of the Mean|12579.5||0.6077|2-Sided|95.0|-18648.6|31627.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Total daytime activity|
1677708|NCT01271933|3087003|Superiority or Other||Mean Difference (Final Values)|-1.9|Standard Error of the Mean|1.29||0.136|2-Sided|95.0|-4.5|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA||||
1677709|NCT01271933|3087004|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|4.06||0.768|2-Sided|95.0|-9.3|6.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA||||
1677710|NCT01271933|3087005|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.24||0.1224|2-Sided|95.0|-0.1|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA||||
1677711|NCT01271933|3087016|Superiority or Other||Mean Difference (Final Values)|1.6|Standard Error of the Mean|1.91||0.4135|2-Sided|95.0|-2.2|5.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Overall Work Impairment|
1677712|NCT01271933|3087016|Superiority or Other||Mean Difference (Final Values)|3.2|Standard Error of the Mean|1.82||0.0819|2-Sided|95.0|-0.4|6.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Activity Impairment|
1677713|NCT01271933|3087016|Superiority or Other||Mean Difference (Final Values)|1.1|Standard Error of the Mean|3.96||0.7892|2-Sided|95.0|-7.0|9.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Impairment While Working|
1677714|NCT01271933|3087016|Superiority or Other||Mean Difference (Final Values)|19.3|Standard Error of the Mean|9.85||0.0562|2-Sided|95.0|-0.5|39.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Percent Work Time Missed|
1677715|NCT01271933|3087018|Superiority or Other||Odds Ratio (OR)|0.98||||0.9577|2-Sided|95.0|0.48|2.01||Nominal p-value for two-sided test|two-sided test|||This analysis is for the domain: Willingness to continue treatment|
1679463|NCT01256385|3089232|Superiority or Other|||||||0.73|||||||Log Rank||||
1677718|NCT01271933|3087020|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.27||0.5869|2-Sided|95.0|-0.7|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Mental fatigue|
1677719|NCT01271933|3087020|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.35||0.0695|2-Sided|95.0|-0.1|1.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Reduced motivation|
1677720|NCT01271933|3087020|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.36||0.4009|2-Sided|95.0|-0.4|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Reduced activity|
1677721|NCT01271933|3087020|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.37||0.4703|2-Sided|95.0|-1.0|0.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Physical Fatigue|
1677722|NCT01271933|3087020|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.31||0.4606|2-Sided|95.0|-0.4|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: General Fatigue|
1677723|NCT01271933|3087022|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|3.91||0.9045|2-Sided|95.0|-8.2|7.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the total score|
1677724|NCT01271933|3087022|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.47||0.9151|2-Sided|95.0|-1.0|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 10: Depression|
1677725|NCT01271933|3087022|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.56||0.8937|2-Sided|95.0|-1.2|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 9: Anxiety|
1677726|NCT01271933|3087022|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.55||0.6601|2-Sided|95.0|-1.3|0.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 8: Stiffness|
1677727|NCT01271933|3087022|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.55||0.5264|2-Sided|95.0|-1.4|0.7||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 7: Rested|
1677728|NCT01271933|3087022|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.46||0.852|2-Sided|95.0|-0.8|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 6: Fatigue|
1677729|NCT01271933|3087022|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.49||0.2742|2-Sided|95.0|-1.5|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 5: Pain|
1677730|NCT01271933|3087022|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.57||0.8824|2-Sided|95.0|-1.0|1.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 4: Do job|
1677731|NCT01271933|3087022|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.35||0.6312|2-Sided|95.0|-0.9|0.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 3: Work missed|
1677732|NCT01271933|3087022|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.64||0.8084|2-Sided|95.0|-1.1|1.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 2: Feel good|
1677733|NCT01271933|3087022|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.41||0.3721|2-Sided|95.0|-0.5|1.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Item 1: Physical activities|
1677734|NCT01271933|3087024|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.65||0.6914|2-Sided|95.0|-1.6|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||HADS-D Depression scale|
1677735|NCT01271933|3087024|Superiority or Other||Mean Difference (Final Values)|0.9|Standard Error of the Mean|0.69||0.1901|2-Sided|95.0|-0.5|2.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||HADS-A Anxiety scale|
1677736|NCT01271933|3087026|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|2.22||0.9347|2-Sided|95.0|-4.2|4.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Mental Component Score|
1677737|NCT01271933|3087026|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|1.78||0.8352|2-Sided|95.0|-3.9|3.2||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Physical Component Score|
1677738|NCT01271933|3087026|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|3.54||0.7067|2-Sided|95.0|-5.7|8.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Mental Health Index|
1677739|NCT01271933|3087026|Superiority or Other||Mean Difference (Final Values)|1.6|Standard Error of the Mean|5.41||0.7636|2-Sided|95.0|-9.1|12.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Role-Emotional|
1677763|NCT01271933|3087055|Superiority or Other|||||||0.0186||||||The p-value was calculated using log-rank test for comparing pregabalin CR with placebo|Log Rank||||
1677740|NCT01271933|3087026|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|4.31||0.9645|2-Sided|95.0|-8.8|8.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Social Functioning|
1677741|NCT01271933|3087026|Superiority or Other||Mean Difference (Final Values)|-3.5|Standard Error of the Mean|4.73||0.4561|2-Sided|95.0|-12.09|5.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Vitality|
1677742|NCT01271933|3087026|Superiority or Other||Mean Difference (Final Values)|-6.1|Standard Error of the Mean|3.45||0.0827|2-Sided|95.0|-12.9|0.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||This analysis is for the domain: SF-36 General Health Perceptions|
1677743|NCT01271933|3087026|Superiority or Other||Mean Difference (Final Values)|3.2|Standard Error of the Mean|4.61||0.4842|2-Sided|95.0|-5.9|12.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Pain Index|
1677744|NCT01271933|3087026|Superiority or Other||Mean Difference (Final Values)|2.6|Standard Error of the Mean|4.89||0.5938|2-Sided|95.0|-7.1|12.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Role-Physical|
1677745|NCT01271933|3087026|Superiority or Other||Mean Difference (Final Values)|-1.4|Standard Error of the Mean|4.1||0.74|2-Sided|95.0|-9.5|6.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: SF-36 Physical Functioning|
1677746|NCT01271933|3087028|Superiority or Other||Odds Ratio (OR)|1.25||||0.4985|2-Sided|95.0|0.66|2.36||Nominal p-value for two-sided test.|two-sided test|||"Odds ratio is the probability of the event occurring in Pregabalin 330 - 495 mg/day relative to the event occurring in Placebo for Pregabalin.~Odds ratio > 1 is in favor of Pregabalin 330 - 495 mg/day."|
1677747|NCT01271933|3087030|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.2||0.3596|2-Sided|95.0|-0.2|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA||||
1677748|NCT01271933|3087031|Superiority or Other||Mean Difference (Final Values)|-5.7|Standard Error of the Mean|3.89||0.1473|2-Sided|95.0|-13.4|2.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep Problems Index II|
1677749|NCT01271933|3087031|Superiority or Other||Mean Difference (Final Values)|-5.8|Standard Error of the Mean|3.81||0.1319|2-Sided|95.0|-13.4|1.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep Problems Index I|
1677750|NCT01271933|3087031|Superiority or Other||Mean Difference (Final Values)|-5.2|Standard Error of the Mean|4.1||0.2041|2-Sided|95.0|-13.4|2.9||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Somnolence|
1677751|NCT01271933|3087031|Superiority or Other||Mean Difference (Final Values)|6.8|Standard Error of the Mean|5.49||0.2159|2-Sided|95.0|-4.1|17.7||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep adequacy|
1677752|NCT01271933|3087031|Superiority or Other||Mean Difference (Final Values)|-3.9|Standard Error of the Mean|3.71||0.2985|2-Sided|95.0|-11.2|3.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Awakening Short of Breath or with a Headache|
1677753|NCT01271933|3087031|Superiority or Other||Mean Difference (Final Values)|5.2|Standard Error of the Mean|5.17||0.3133|2-Sided|95.0|-5.0|15.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Snoring|
1677754|NCT01271933|3087031|Superiority or Other||Mean Difference (Final Values)|-9.9|Standard Error of the Mean|4.52||0.0305|2-Sided|95.0|-18.9|1.0||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Sleep disturbance|
1677755|NCT01271933|3087034|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.48||0.1845|2-Sided|95.0|-1.6|0.3||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA||||
1677756|NCT01271933|3087036|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.34||0.2009|2-Sided|95.0|-0.2|1.1||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA||||
1677757|NCT01271933|3087037|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.2||0.3779|2-Sided|95.0|-0.2|0.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA||||
1677758|NCT01271933|3087038|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.41||0.4571|2-Sided|95.0|-0.5|1.1||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA||||
1677759|NCT01271933|3087039|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|9.26||0.8915|2-Sided|95.0|-17.1|19.6||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA|||This analysis is for the domain: Subjective Latency to Sleep Onset|
1677760|NCT01271933|3087039|Superiority or Other||Mean Difference (Final Values)|-5.6|Standard Error of the Mean|7.12||0.4314|2-Sided|95.0|-19.7|8.5||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA|||This analysis is for the domain: Subjective Wake after Sleep Onset|
1677761|NCT01271933|3087048|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.4||0.9247|2-Sided|95.0|-0.8|0.8||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model.|ANCOVA||||
1677762|NCT01271933|3087051|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.41||0.331|2-Sided|95.0|-1.2|0.4||Estimates and p-values are from a ANCOVA main effects model with baseline value, center, treatment in the model|ANCOVA||||
1677764|NCT01271855|3087067|Superiority||Z-Score|2.34||||0.02|2-Sided||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized version of the Wilcoxon test statistic. In this study, z-scores with an absolute value exceeding 1.96 signal the two groups have meaningfully different satisfaction scores. Other values fail to reject the null hypothesis|The null hypothesis is that there is no difference in the pain satisfaction score between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group at discharge|
1677765|NCT01271855|3087068|Superiority||Odds Ratio (OR)|1.88||||0.3|2-Sided|95.0|0.57|6.21|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of taking additional pain medications between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.|
1677766|NCT01271855|3087069|Superiority||Z-Score|0.93||||0.35|2-Sided||||||Wilcoxon (Mann-Whitney)||The z-score is a standardized version of the Wilcoxon test statistic. In this study, z-scores with an absolute value exceeding 1.96 signal the two groups have meaningfully different pain scores. Other values would fail to reject the null hypothesis.|The null hypothesis is that there is no difference in the visual analogue pain score scale (VAS) between participants in the Glycerin suppository group and those in the Belladonna and opioid suppository group 24-hours after delivery.|
1677767|NCT01271712|3087108|Superiority or Other (legacy)||Hazard Ratio (HR)|0.248|||||2-Sided|95.0|0.17|0.364|||||||
1677768|NCT01271712|3087108|Superiority or Other (legacy)||||||<|1e-06|||||||Log Rank|stratified|||
1677769|NCT01271712|3087109|Superiority or Other (legacy)||Hazard Ratio (HR)|0.909|||||2-Sided|95.0|0.653|1.265|||||regorafenib over control. 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015.|Hazard ratio and its 95% CI was based on stratified Cox Regression Model|
1677770|NCT01271712|3087109|Superiority or Other (legacy)|||||||0.285777|||||||Log Rank|stratified|||
1677771|NCT01271712|3087110|Superiority or Other (legacy)||Hazard Ratio (HR)|0.268|||||2-Sided|95.0|0.185|0.388|||||regorafenib over placebo|Hazard ratio and its 95% CI (Confidence Interval) was based on stratified Cox Regression Model|
1677772|NCT01271712|3087110|Superiority or Other (legacy)||||||<|1e-06|||||||Log Rank|stratified||The two treatment groups were compared using a stratified log rank test with a one-sided alpha of 0.01 stratified by (3rd vs 4th-line; and geographical region). The null hypothesis that both treatment arms have the same PFS distribution was tested against the alternative hypothesis that the distribution of PFS in the regorafenib arm is different from the control arm according to a proportional hazards relation between the treatment arms.|
1677773|NCT01270971|3087146|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1677774|NCT01270971|3087147|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1677775|NCT01270971|3087148|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1677776|NCT01270971|3087149|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1677777|NCT01270958|3087152|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677778|NCT01270958|3087153|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677779|NCT01270958|3087154|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677780|NCT01270958|3087155|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677781|NCT01270958|3087156|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677782|NCT01270958|3087157|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677783|NCT01270958|3087158|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677784|NCT01270958|3087159|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677785|NCT01270958|3087160|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677786|NCT01270958|3087161|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677787|NCT01270958|3087162|Superiority or Other||||||<|0.01||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677788|NCT01270958|3087163|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677789|NCT01270958|3087164|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677790|NCT01270958|3087165|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677791|NCT01270958|3087166|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677792|NCT01270958|3087167|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677793|NCT01270958|3087168|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677794|NCT01270958|3087169|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677795|NCT01270958|3087170|Superiority or Other||||||>|0.05||||||Comparison between Screening value and Visit 3 value|t-test, 2 sided||||
1677796|NCT01270828|3087190|Superiority or Other||Odds Ratio (OR)|1.61||||0.0901|2-Sided|95.0|0.93|2.81|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio > 1 was in favor of pregabalin CR.|This analysis is for 'Willingness to continue treatment'. Proportional odds logistic regression was used with a term for treatment in the model.|
1677797|NCT01270828|3087190|Superiority or Other||Odds Ratio (OR)|2.48||||0.0378|2-Sided|95.0|1.05|5.85|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio > 1 was in favor of pregabalin CR.|This analysis is for 'Satisfaction with treatment'. Proportional odds logistic regression was used with a term for treatment in the model.|
1677798|NCT01270828|3087190|Superiority or Other||Odds Ratio (OR)|4.77||||0.0161|2-Sided|95.0|1.34|17.0|||Regression, Logistic||Odds ratio was the probability of the event occurring in pregabalin CR DB relative to the event occurring in placebo DB. Odds ratio > 1 was in favor of pregabalin CR.|This analysis is for 'Benefit from treatment'. Proportional odds logistic regression was used with a term for treatment in the model.|
1677799|NCT01270828|3087191|Superiority or Other||Mean Difference (Final Values)|-4.2|||<|0.0001|2-Sided|95.0|-6.0|-2.4|||ANCOVA|||"This ANCOVA model analysis is for Pain Interference Index-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."|
1677800|NCT01270828|3087191|Superiority or Other||Mean Difference (Final Values)|-4.6|||<|0.0001|2-Sided|95.0|-6.5|-2.7|||ANCOVA|||"This ANCOVA model analysis is for Pain Interference Index-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."|
1677801|NCT01270828|3087191|Superiority or Other||Mean Difference (Final Values)|-3.8|||<|0.0001|2-Sided|95.0|-5.0|-2.7|||ANCOVA|||This ANCOVA model analysis is for Pain Severity Index-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677802|NCT01270828|3087191|Superiority or Other||Mean Difference (Final Values)|-4.2|||<|0.0001|2-Sided|95.0|-5.5|-3.0|||ANCOVA|||This ANCOVA model analysis is for Pain Severity Index-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677803|NCT01270828|3087192|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.0217|2-Sided|95.0|-1.1|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Depression-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677804|NCT01270828|3087192|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.0166|2-Sided|95.0|-1.2|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Depression-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677805|NCT01270828|3087192|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.0027|2-Sided|95.0|-1.3|-0.3|||ANCOVA|||This ANCOVA model analysis is for HADS-Anxiety-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677806|NCT01270828|3087192|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.0154|2-Sided|95.0|-1.2|-0.1|||ANCOVA|||This ANCOVA model analysis is for HADS-Anxiety-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677807|NCT01270828|3087193|Superiority or Other||Mean Difference (Final Values)|-0.9|||<|0.0001|2-Sided|95.0|-1.12|-0.58|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.|
1677808|NCT01270828|3087193|Superiority or Other||Mean Difference (Final Values)|-0.9|||<|0.0001|2-Sided|95.0|-1.23|-0.64|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19.Estimates and p-values are from an analysis of covariance main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.|
1677809|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|5.4||||0.0107|2-Sided|95.0|1.3|9.5|||ANCOVA|||This ANCOVA model analysis is for Role Physical-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677810|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|4.9||||0.025|2-Sided|95.0|0.6|9.3|||ANCOVA|||This ANCOVA model analysis is for Role Physical-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677811|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|3.4||||0.0439|2-Sided|95.0|0.1|6.7|||ANCOVA|||This ANCOVA model analysis is for Physical functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677812|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|2.8||||0.1466|2-Sided|95.0|-1.0|6.7|||ANCOVA|||This ANCOVA model analysis is for Physical functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677813|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|1.2||||0.1669|2-Sided|95.0|-0.5|2.8|||ANCOVA|||This ANCOVA model analysis is for Mental component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677814|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|0.9||||0.2097|2-Sided|95.0|-0.8|2.5|||ANCOVA|||This ANCOVA model analysis is for Mental component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677815|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|2.3||||0.0008|2-Sided|95.0|1.0|3.7|||ANCOVA|||This ANCOVA model analysis is for Physical component-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677816|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|2.0||||0.0082|2-Sided|95.0|0.5|3.4|||ANCOVA|||This ANCOVA model analysis is for Physical component-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677817|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|2.5||||0.0806|2-Sided|95.0|-0.3|5.2|||ANCOVA|||This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677903|NCT01269918|3087313|Superiority or Other||Mean Difference (Final Values)|-6.0|||<|0.001|2-Sided|95.0|-10.0|3.0|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on heart rate was assessed using a linear mixed effects model adjusting for baseline heart rate.|
1677818|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|1.6||||0.2749|2-Sided|95.0|-1.2|4.3|||ANCOVA|||This ANCOVA model analysis is for Mental Health-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677819|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|4.0||||0.0365|2-Sided|95.0|0.3|7.8|||ANCOVA|||This ANCOVA model analysis is for Role-Emotional-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677820|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|3.3||||0.0847|2-Sided|95.0|-0.5|7.1|||ANCOVA|||This ANCOVA model analysis is for Role-Emotional-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677821|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|2.1||||0.221|2-Sided|95.0|-1.3|5.5|||ANCOVA|||This ANCOVA model analysis is for Social Functioning-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677822|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|2.8||||0.1197|2-Sided|95.0|-0.7|6.4|||ANCOVA|||This ANCOVA model analysis is for Social Functioning-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677823|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|3.0||||0.0684|2-Sided|95.0|-0.2|6.2|||ANCOVA|||This ANCOVA model analysis is for Vitality-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677824|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|3.0||||0.0735|2-Sided|95.0|-0.3|6.4|||ANCOVA|||This ANCOVA model analysis is for Vitality-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677825|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|5.4|||<|0.0001|2-Sided|95.0|2.8|8.0|||ANCOVA|||"This ANCOVA model analysis is for General Health Perceptions-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."|
1677826|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|3.2|||<|0.0275|2-Sided|95.0|0.4|6.0|||ANCOVA|||"This ANCOVA model analysis is for General Health Perceptions-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."|
1677827|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|7.7|||<|0.0001|2-Sided|95.0|4.0|11.3|||ANCOVA|||This ANCOVA model analysis is for Bodily pain-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677828|NCT01270828|3087194|Superiority or Other||Mean Difference (Final Values)|7.4|||<|0.0003|2-Sided|95.0|3.4|11.5|||ANCOVA|||This ANCOVA model analysis is for Bodily pain-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677829|NCT01270828|3087195|Superiority or Other||Odds Ratio (OR)|2.32||||0.0009|2-Sided|95.0|1.41|3.81|||Regression, Logistic||"Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.~Odds ratio > 1 is in favor of Pregabalin DB."|This analysis is for the categorized score. Proportional odds Logistic regression with a term for treatment in the model.|
1677830|NCT01270828|3087195|Superiority or Other||Odds Ratio (OR)|1.85||||0.0007|2-Sided|95.0|1.3|2.65|||Regression, Logistic||"Odds ratio is the probability of the event occurring in Pregabalin DB relative to the event occurring in Placebo DB.~Odds ratio > 1 is in favor of Pregabalin DB."|This analysis is for the original score. Proportional odds Logistic regression with a term for treatment in the model.|
1677831|NCT01270828|3087196|Superiority or Other|||||||0.987|||||||Chi-squared|||This analysis is for Week 19|
1677832|NCT01270828|3087196|Superiority or Other|||||||0.432|||||||Chi-squared|||This analysis is for Week 6|
1677833|NCT01270828|3087197|Superiority or Other||Mean Difference (Final Values)|0.2||||0.0363||95.0|0.0|0.5|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677834|NCT01270828|3087197|Superiority or Other||Mean Difference (Final Values)|0.2||||0.1635|2-Sided|95.0|-0.1|0.4|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677835|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|0.1||||0.9282|2-Sided|95.0|-2.9|3.2|||ANCOVA|||This ANCOVA model analysis is for Somnolence-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677836|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9816|2-Sided|95.0|-3.2|3.1|||ANCOVA|||This ANCOVA model analysis is for Somnolence-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677837|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|2.7||||0.2742|2-Sided|95.0|-2.2|7.6|||ANCOVA|||This ANCOVA model analysis is for Sleep adequacy-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677838|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|2.5||||0.3223|2-Sided|95.0|-2.4|7.3|||ANCOVA|||This ANCOVA model analysis is for Sleep adequacy-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677839|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.5639|2-Sided|95.0|-4.2|2.3|||ANCOVA|||"This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."|
1677840|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|-1.5||||0.3714|2-Sided|95.0|-4.7|1.8|||ANCOVA|||"This ANCOVA model analysis is for Awaken Short of Breath or with a Headache-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."|
1677841|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.452|2-Sided|95.0|-5.2|2.3|||ANCOVA|||This ANCOVA model analysis is for Snoring-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677842|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|1.4||||0.5264|2-Sided|95.0|-2.8|5.6|||ANCOVA|||This ANCOVA model analysis is for Snoring-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677843|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|-8.7|||<|0.0001|2-Sided|95.0|-12.2|-5.2|||ANCOVA|||This ANCOVA model analysis is for Sleep Disturbance-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677844|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|-7.3|||<|0.0002|2-Sided|95.0|-11.1|-3.5|||ANCOVA|||This ANCOVA model analysis is for Sleep Disturbance-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677845|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|-4.0|||<|0.0033|2-Sided|95.0|-6.7|-1.4|||ANCOVA|||"This ANCOVA model analysis is for Sleep Problem Index II-DB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."|
1677846|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|-3.8|||<|0.0098|2-Sided|95.0|-6.6|-0.9|||ANCOVA|||"This ANCOVA model analysis is for Sleep Problem Index II-SB Baseline to Week 19.~Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model."|
1677847|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|-3.3|||<|0.0223|2-Sided|95.0|-6.1|-0.5|||ANCOVA|||This ANCOVA model analysis is for Sleep Problem Index I-DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677848|NCT01270828|3087198|Superiority or Other||Mean Difference (Final Values)|-3.2|||<|0.0324|2-Sided|95.0|-6.1|-0.3|||ANCOVA|||This ANCOVA model analysis is for Sleep Problem Index I-SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677849|NCT01270828|3087199|Superiority or Other||Mean Difference (Final Values)|-1.0|||<|0.0001|2-Sided|95.0|-1.34|-0.65|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677850|NCT01270828|3087199|Superiority or Other||Mean Difference (Final Values)|-1.1|||<|0.0001|2-Sided|95.0|-1.47|-0.75|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an analysis of covariance main effects model with SB baseline value, center, and treatment in the model.|
1677851|NCT01270828|3087200|Superiority or Other||Mean Difference (Final Values)|-0.91|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-1.21|-0.61|||ANCOVA|||This ANCOVA model analysis is for DB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.|
1677852|NCT01270828|3087200|Superiority or Other||Mean Difference (Final Values)|-0.94|Standard Error of the Mean|0.16|<|0.0001|2-Sided|95.0|-1.26|-0.62|||ANCOVA|||This ANCOVA model analysis is for SB Baseline to Week 19. Estimates and p-values are from an ANCOVA main effects model with baseline value, pooled center decided before unblinding, and treatment in the model.|
1677853|NCT01270828|3087201|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Chi-square test was used for analysis.|
1677854|NCT01270828|3087202|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Chi-square test was used for analysis.|
1677855|NCT01270828|3087203|Superiority or Other||||||<|0.0001|||||||Log Rank|||Kaplan-Meier method was used for the analysis.|
1677856|NCT01270828|3087204|Superiority or Other||||||<|0.0001|||||||Log Rank|||Kaplan-Meier method was used for the analysis.|
1677857|NCT01270802|3087205|Superiority or Other||Mean Difference (Net)|-1.63|Standard Error of the Mean|5.52||0.4|2-Sided|95.0|-13.04|9.77||P-value was not adjusted for multiple comparisons. P<0.05 was considered statistically significant.|t-test, 2 sided||||
1677858|NCT01270802|3087206|Superiority or Other||Mean Difference (Net)|0.81|Standard Error of the Mean|0.76||0.67|2-Sided|95.0|-0.75|2.37||P-value was not adjusted for multiple comparisons; P<0.05 was considered statistically significant.|t-test, 2 sided|||We assumed that the declines in FMD seen with TDF/FTC/EFV in our previous study would fully reverse. Thus, the clinically relevant effect size to be detected for FMD change was +3.12% (SD 4%) in those switching from EFV to RAL. Using a two-sample, independent, two-tailed t-test with 5% type I error and 20% type II error, a sample size of 13 per group would be needed to find a difference in FMD between groups. Allowing for a 10% dropout rate, we planned to recruit 15 subjects per group.|
1677859|NCT01270464|3087273|Superiority or Other||Mean Difference (Final Values)|-0.323|Standard Error of the Mean|0.0243||0|2-Sided|95.0|-0.37|-0.275||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677881|NCT01270139|3087289|Non-Inferiority or Equivalence|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05||||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and Stenting control|
1677860|NCT01270464|3087273|Superiority or Other||Mean Difference (Final Values)|-0.494|Standard Error of the Mean|0.0242||0|2-Sided|95.0|-0.542|-0.447||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Regression, Logistic|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677861|NCT01270464|3087274|Superiority or Other||Mean Difference (Final Values)|-0.648|Standard Error of the Mean|0.2559||0.0119|2-Sided|95.0|-1.152|-0.144||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677862|NCT01270464|3087274|Superiority or Other||Mean Difference (Final Values)|-0.624|Standard Error of the Mean|0.2551||0.0151|2-Sided|95.0|-1.126|-0.121||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677863|NCT01270464|3087275|Superiority or Other||Mean Difference (Final Values)|0.051|Standard Error of the Mean|0.0193||0.0094|2-Sided|95.0|0.012|0.089||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677864|NCT01270464|3087275|Superiority or Other||Mean Difference (Final Values)|0.047|Standard Error of the Mean|0.0193||0.016|2-Sided|95.0|0.009|0.085||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677865|NCT01270464|3087276|Superiority or Other||Mean Difference (Final Values)|0.278|Standard Error of the Mean|0.1591||0.0822|2-Sided|95.0|-0.036|0.591||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677866|NCT01270464|3087276|Superiority or Other||Mean Difference (Final Values)|0.359|Standard Error of the Mean|0.1582||0.0241|2-Sided|95.0|0.047|0.67||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677867|NCT01270464|3087277|Superiority or Other||Mean Difference (Final Values)|-0.238|Standard Error of the Mean|0.1108||0.0329|2-Sided|95.0|-0.456|-0.019||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677868|NCT01270464|3087277|Superiority or Other||Mean Difference (Final Values)|-0.359|Standard Error of the Mean|0.111||0.0014|2-Sided|95.0|-0.577|-0.14||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677869|NCT01270464|3087279|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.1215||0.802|2-Sided|95.0|-0.209|0.27||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677870|NCT01270464|3087279|Superiority or Other||Mean Difference (Final Values)|0.233|Standard Error of the Mean|0.1212||0.0552|2-Sided|95.0|-0.005|0.472||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677901|NCT01269918|3087311|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.07|2-Sided|95.0|-0.6|0.03|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on Aldrete score estimated using a linear mixed effects model adjusting for baseline Aldrete score.|
1678023|NCT01265797|3087677|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.83|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1677871|NCT01270464|3087280|Superiority or Other||Mean Difference (Final Values)|0.048|Standard Error of the Mean|0.0543||0.3731|2-Sided|95.0|-0.058|0.155||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677872|NCT01270464|3087280|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.0543||0.0174|2-Sided|95.0|0.023|0.237||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||As with the primary outcome, this respiratory test outcome was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677873|NCT01270464|3087281|Superiority or Other||Mean Difference (Final Values)|0.115|Standard Error of the Mean|0.0508||0.0237|2-Sided|95.0|0.016|0.215||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||The primary variable was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677874|NCT01270464|3087281|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.0507||0.0018|2-Sided|95.0|0.06|0.259||The overall treatment effect for each reslizumab dose was compared to placebo using a 2-sided t-test at the a priori significance level of 0.05.|Mixed Models Analysis|||The primary variable was analyzed using a mixed-effect model for repeated measures (MMRM) with fixed effects (treatment, stratification factors, sex, visit, interaction of treatment and visit), covariates (height, baseline value), and patient as the random effect for the repeated measurements.|
1677875|NCT01270139|3087283|Other|The Kolmogorov–Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher’s exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher’s post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was >0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|t-test, 2 sided|||Null hypothesis is ex-vivo arm with exposure of nanoparticles is superior to saline control.|
1677876|NCT01270139|3087284|Other|The Kolmogorov–Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher’s exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher’s post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was >0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.|
1677877|NCT01270139|3087285|Other|The Kolmogorov–Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher’s exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher’s post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was >0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.|
1677878|NCT01270139|3087286|Other|The Kolmogorov–Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher’s exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher’s post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was >0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.|
1677879|NCT01270139|3087287|Other|The Kolmogorov–Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher’s exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher’s post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was >0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.|
1677880|NCT01270139|3087288|Non-Inferiority or Equivalence|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05||||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano groups is superior to Ferro group and Stenting control|
1677902|NCT01269918|3087312|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.16|2-Sided|95.0|-2.6|0.5|||Mixed Models Analysis|||Dexmedetomidine versus remifentanyl on SOMCT estimated using a linear mixed effects model adjusting for baseline SOMCT score.|
1677882|NCT01270139|3087290|Non-Inferiority or Equivalence|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05||||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano groups is superior to Ferro group and Stenting control|
1677883|NCT01270139|3087291|Non-Inferiority or Equivalence|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05||||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and stenting control|
1677884|NCT01270139|3087292|Non-Inferiority or Equivalence|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|||||||Chi-squared|||The null hypothesis is Nanogroup is superior to Ferro group and stenting control|
1677885|NCT01270139|3087293|Non-Inferiority or Equivalence|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05||||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nanogroup is superior to Ferro group and stenting control|
1677886|NCT01270139|3087294|Non-Inferiority or Equivalence|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05||||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||The null hypothesis is Nano group is superior to Ferro group and stenting control|
1677887|NCT01270139|3087295|Non-Inferiority or Equivalence|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|||||||Chi-squared|||The null hypothesis is Nano group is superior to Ferro group and Stenting control|
1677888|NCT01270139|3087296|Non-Inferiority or Equivalence|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|||||||Chi-squared|||The null hypothesis is Nano group is superior to Ferro group and Stenting control|
1677889|NCT01270139|3087297|Non-Inferiority or Equivalence|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05|||||||Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control|
1677890|NCT01270139|3087298|Non-Inferiority or Equivalence|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05||||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||Null hypothesis - Nano group is superior to Ferro group and stenting control|
1677891|NCT01270139|3087299|Other|The Kolmogorov–Smirnov test was used to prove Gaussian distribution allowing for calculation of the mean and standard deviation. Non-Gaussian samples are described by median and range. Discriminant variables are evaluated with the two-sided Fisher’s exact test. Differences between three groups were analyzed by means of a repeated-measures oneway ANOVA followed by a Fisher’s post hoc test. We used the Cox proportional hazards ratios (HR) and 95% CI for the end points.|||||<|0.05||||||"A p value was calculated for each comparison separately, and indicated as for all comparisons. In case if p value was >0.05, it was mentioned with a separated info. The threshold for statistical significance was a p value below 0.05."|Kaplan-Meier|||Null hypothesis is Nano group is superior to Ferro group and stenting control.|
1677892|NCT01270139|3087300|Non-Inferiority or Equivalence|The sample size was not defined on the basis of an end-point hypothesis, therefore the present FIM study should be considered as hypothesis-generating.|||||<|0.05||||||Overall comparison was assessed by applying the Friedman test, and pairwise comparisons between post-procedure and follow-up (nano vs ferro, nano vs stenting, and ferro vs stenting) were performed by ANOVA.|ANOVA|||Null hypothesis - Nano group is superior to Ferro group and stenting control|
1677893|NCT01269918|3087303|Superiority or Other||Risk Ratio (RR)|0.4||||0.21|2-Sided|95.0|0.1|1.7|||Chi-squared|||Dexmedetomidine versus remifentanyl on incidence of shivering estimated from a chi square test.|
1677894|NCT01269918|3087304|Superiority or Other||Risk Ratio (RR)|0.4||||0.16|2-Sided|95.0|0.07|1.7|||Chi-squared|||Dexmedetomidine versus remifentanyl on postoperative vomiting estimated from a chi square test.|
1677895|NCT01269918|3087305|Superiority or Other||Risk Ratio (RR)|1.0||||0.91|2-Sided|95.0|0.5|2.2|||Chi-squared|||Dexmedetomidine versus remifentanyl on postoperative nausea estimated from chi squared test.|
1677896|NCT01269918|3087306|Superiority or Other||Hazard Ratio (HR)|1.1||||0.45|2-Sided|95.0|0.81|1.62|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to PACU discharge estimated using Cox proportional hazard regression|
1677897|NCT01269918|3087307|Superiority or Other||Hazard Ratio (HR)|0.68||||0.022|2-Sided|95.0|0.48|0.95|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to fitness discharge estimated using Cox regression.|
1677898|NCT01269918|3087308|Superiority or Other||Hazard Ratio (HR)|0.12|||<|0.001|2-Sided|95.0|0.07|0.19|||Regression, Cox|||Remifentanyl versus dexmedetomidine on time to recall assessed using Cox regression.|
1677899|NCT01269918|3087309|Superiority or Other||Hazard Ratio (HR)|0.11|||<|0.001|2-Sided|95.0|0.07|0.18|||Regression, Cox|||Remifentanyl versus Dexmedetomidine on time to open eyes estimated using Cox regression.|
1677900|NCT01269918|3087310|Superiority or Other||Median Difference (Final Values)|-1.0||||0.009|2-Sided|95.0|-1.0|-0.001|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on Nursing workload comparison estimated using a Wilcoxon rank sum test.|
1677904|NCT01269918|3087314|Superiority or Other||Median Difference (Final Values)|-5.0|||<|0.001|2-Sided|97.5|-10.0|-3.0|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test|
1677905|NCT01269918|3087314|Non-Inferiority or Equivalence|Noninferiority delta = 2 mg opioid|Median Difference (Final Values)|-5.0|||<|0.001|2-Sided|95.0|-10.0|-5.0|||Wilcoxon (Mann-Whitney)|||Dexmedetomidine versus remifentanyl on opioid consumption estimated from a Wilcoxon rank sum test|
1677906|NCT01269918|3087315|Superiority or Other||Mean Difference (Final Values)|-1.9|||<|0.001|2-Sided|97.5|-2.8|-0.9|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.|
1677907|NCT01269918|3087315|Non-Inferiority or Equivalence|We used a noninferiority delta of 1 point. If noninferiority was detected, we proceeded to test for superiority.|Mean Difference (Final Values)|-1.9|||<|0.001|2-Sided|95.0|-2.7|-1.1|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on VAS pain score estimated from a 1-tailed t test from a repeated measures ANOVA model.|
1677908|NCT01269918|3087316|Superiority or Other||Mean Difference (Final Values)|-9.0|||<|0.001|2-Sided|97.5|-13.0|-4.0|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.|
1677909|NCT01269918|3087316|Non-Inferiority or Equivalence|We used a noninferiority delta of 7.5 mmHg. If noninferiority was detected, we proceeded to test for superiority.|Mean Difference (Final Values)|-9.0|||<|0.001|2-Sided|95.0|-13.0|-5.0|||t-test, 1 sided|||Dexmedetomidine versus remifentanyl on MAP collapsed over time was estimated using a 1-tailed t test from a repeated measures ANOVA model.|
1677910|NCT01269125|3087333|Superiority or Other||Odds Ratio (OR)|-0.15|Standard Error of the Mean|0.0||0.22||95.0|-0.4|0.1|||Chi-squared|||In order to handle the problem of small sample size combined with the inability to identify the theoretical statistical distribution of data, bootstrap techniques are used (10). Ader and co-workers recommend the bootstrap procedure when (a) the theoretical distribution is complicated or unknown, and/or (b) power calculations have to be performed and a small sample is available (11). Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.|
1677911|NCT01269125|3087333|Superiority or Other||Odds Ratio (OR)|-0.1|Standard Error of the Mean|0.0||0.48||95.0|-0.4|0.2|||Chi-squared|||In order to handle the problem of small sample size combined with the inability to identify the theoretical statistical distribution of data, bootstrap techniques are used (10). Ader and co-workers recommend the bootstrap procedure when (a) the theoretical distribution is complicated or unknown, and/or (b) power calculations have to be performed and a small sample is available (11). Finally, the bootstrap distribution has been used in order to calculate all the confidence intervals.|
1677912|NCT01269125|3087333|Superiority or Other||Odds Ratio (OR)|0.05|Standard Error of the Mean|0.0||0.8||95.0|-0.2|0.3|||Chi-squared||||
1677913|NCT01269125|3087337|Superiority or Other||Odds Ratio (OR)|0.28|Standard Error of the Mean|0.0||0.8|2-Sided|95.0|-0.2|0.3|||Chi-squared||||
1677914|NCT01269047|3087338|Other||Mean Difference (Final Values)|-0.004|Standard Deviation|1.0||1|2-Sided|95.0|-0.62|0.61|||t-test, 2 sided||||
1677915|NCT01269047|3087338|Other||Mean Difference (Final Values)|0.23|Standard Deviation|0.6||0.18|2-Sided|95.0|-0.12|0.57|||t-test, 2 sided||||
1677916|NCT01269047|3087338|Other||Mean Difference (Final Values)|0.13|Standard Deviation|0.6||0.48|2-Sided|95.0|-0.25|0.5|||t-test, 2 sided||||
1677917|NCT01269047|3087338|Other||Mean Difference (Final Values)|0.3|Standard Deviation|0.8||0.2|2-Sided|95.0|-0.21|0.81|||t-test, 2 sided||||
1677918|NCT01269047|3087339|Other||Mean Difference (Final Values)|-0.66|Standard Deviation|2.0||0.37|2-Sided|95.0|-2.3|0.98|||ANOVA||||
1677919|NCT01269047|3087339|Other||Mean Difference (Final Values)|-4.2|Standard Deviation|2.6||0.003|2-Sided|95.0|-6.4|-2.0|||ANOVA||||
1677920|NCT01269047|3087339|Other||Mean Difference (Final Values)|-3.5|Standard Deviation|2.7||0.008|2-Sided|95.0|-5.8|-1.3|||ANOVA||||
1677921|NCT01269047|3087339|Other||Mean Difference (Final Values)|-2.2|Standard Deviation|2.4||0.04|2-Sided|95.0|-4.2|-0.2|||ANOVA||||
1677922|NCT01268891|3087341|Superiority or Other||Mean Difference (Final Values)|-1.35|Standard Error of the Mean|0.98||0.17|2-Sided|95.0|-3.29|0.59|||ANCOVA||||
1677923|NCT01268891|3087342|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.57||0.2258|2-Sided|95.0|-1.84|0.44|||ANCOVA||||
1677924|NCT01268891|3087343|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.18||0.0946|2-Sided|95.0|-0.65|0.05|||ANCOVA||||
1677925|NCT01268891|3087344|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.35||0.3257|2-Sided|90.0|-0.93|0.23||The threshold for statistical significance in showing a trend for this study is 0.10.|ANCOVA|||The power for this study, which is designed to show a trend, that is, to show a clinical difference in the primary outcome measure, is 72%.|
1677926|NCT01268644|3087349|Superiority|||||||0.75|||||||Mixed Models Analysis||||
1677927|NCT01268644|3087350|Superiority|||||||0.009||||||P value comparing week 0 to week 12.|Mixed Models Analysis||||
1677928|NCT01268644|3087351|Superiority|||||||0.01||||||P value comparing week 0 with week 12.|Mixed Models Analysis||||
1677929|NCT01268644|3087352|Superiority|||||||0.14||||||P value comparing baseline to week 12|Mixed Models Analysis||||
1677930|NCT01268111|3087402|Superiority or Other|||||||0.4|||||||t-test, 2 sided||||
1677931|NCT01268098|3087403|Superiority or Other|||||||0.258|||||||Fisher Exact|The 2-sided Fisher’s Exact test was utilized to test for difference betweenthe two dose arms.||The null hypothesis corresponding to this endpoint is that the percentages of subjects who meet the endpoint criteria are the same for both dose arms.|
1677932|NCT01268098|3087404|Superiority or Other||Treatment difference|5.0|||>|0.999|2-Sided|95.0|-20.6|30.7||All hypothesis testings in this study were based on type I error of 0.05. Adjustment for multiplicity was not applied.|Fisher Exact|The 2-sided Fisher’s Exact test was utilized to test for difference between the two dose arms.|The 2-sided asymptotic 95% confidence interval is based on normal approximation.|The null hypothesis corresponding to the primary efficacy endpoint is that the percentages of subjects who meet the endpoint criteria are the same for both dose arms. This sample size for this study was not based on the statistical considerations.|
1677956|NCT01266161|3087592|Superiority||CMH-adjusted proportion|-0.73|||<|0.001|2-Sided|95.0|-0.91|-0.55||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the first dosing interval.|
1677933|NCT01267929|3087414|Superiority or Other||Mean Difference (Net)|-0.7|Standard Error of the Mean|2.7||0.78|2-Sided|95.0|-6.3|4.7||Statistical analysis was conducted using STATA. Analysis of Covariance (ANCOVA) was used to compare mean score of GMFM at the sixth month between two groups.|ANCOVA|||A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the sixth month compared to those in the control group after adjusted for the baseline level.|
1677934|NCT01267929|3087414|Superiority or Other||Mean Difference (Final Values)|2.1|Standard Error of the Mean|2.14||0.34|2-Sided|95.0|-2.3|6.5||Statistical analysis was conducted using STATA. Analysis of Covariance (ANCOVA) was used to compare mean score of GMFM at the second month between two groups.|ANCOVA|||A sample size of 30 children, 15 for each group, was needed to obtain 80% power at 0.05 level of significance (two-sided) to test that the successful event rate (increasing GMFM scores at least 30% from baseline at the end of 2 months) in experimental group and control group of 0.3 and 0.8 respectively. The mean changes of GMFM total scores in the experimental group at the second month compared to those in the control group after adjusted for the baseline level.|
1677935|NCT01267266|3087448|Superiority or Other|||||||0.2|||||||Log Rank||||
1677936|NCT01267201|3087463|Superiority or Other||Ratio of adjusted geometric means|83.89|||||2-Sided|90.0|78.06|90.17||||||Natural log transformed Cmax of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1677937|NCT01267201|3087463|Superiority or Other||Ratio of adjusted geometric means|94.76|||||2-Sided|90.0|88.06|101.98||||||Natural log transformed Cmax of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1677938|NCT01267201|3087464|Superiority or Other||Ratio of adjusted geometric means|90.22|||||2-Sided|90.0|86.49|94.11||||||Natural log transformed AUC (0 - ∞) of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1677939|NCT01267201|3087464|Superiority or Other||Ratio of adjusted geometric means|92.11|||||2-Sided|90.0|88.23|96.15||||||Natural log transformed AUC (0 - ∞) of methylprednisolone was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1677940|NCT01267019|3087483|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis||||
1677941|NCT01267019|3087484|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis||||
1677942|NCT01267019|3087485|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||This is a statistical analysis to determine the training effect of social cognitive skills training (in vivo and social cog versus control).|
1677943|NCT01266967|3087539|Superiority or Other||percentage of participants|37.0|||<|0.0001|2-Sided|95.0|25.3|49.8|||Exact Test||The estimated value represents the percentage of participants with OIR.||
1677944|NCT01266967|3087539|Superiority or Other||percentage of participants|41.0|||<|0.0001|2-Sided|95.0|29.3|52.6|||Exact Test||The estimated value represents the percentage of participants with OIR.||
1677945|NCT01266876|3087558|Superiority or Other|||||||0.0113||||||Threshold for significance at ≤ 0.05.|ANCOVA||||
1677946|NCT01266876|3087558|Superiority or Other|||||||0.0035||||||Threshold for significance at ≤ 0.05.|ANCOVA||||
1677947|NCT01266876|3087558|Superiority or Other|||||||0||||||Threshold for significance at ≤ 0.05.|ANCOVA||||
1677948|NCT01266876|3087558|Superiority or Other|||||||0||||||Threshold for significance at ≤ 0.05.|ANCOVA|||"Each treatment group was compared to placebo using ANCOVA-derived contrasts.~A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:~Alirocumab 150 mg Q2W versus placebo~Alirocumab 300 mg Q4W versus placebo~Alirocumab 200 mg Q4W versus placebo~Alirocumab 150 mg Q4W versus placebo~Testing continued only when high-order test was statistically significant at 5% level."|
1677949|NCT01266590|3087576|Superiority or Other|||||||0.0664|||||||Wilcoxon Signed Rank||||
1677950|NCT01266161|3087589|Superiority||Gamma statistic|0.79|||<|0.001|2-Sided|95.0|0.66|0.92|||Cochran-Mantel-Haenszel|p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.||Ibuprofen versus placebo at 48 hours|
1677951|NCT01266161|3087589|Superiority||Gamma statistic|0.85|||<|0.001|2-Sided|95.0|0.74|0.95||p-Value from the CMH test with modified ridit scores, controlling for baseline PSR score and gender.|Cochran-Mantel-Haenszel|||Ibuprofen versus placebo at 24 hours|
1677952|NCT01266161|3087592|Superiority||CMH-adjusted proportion|-0.7|||<|0.001|2-Sided|95.0|-0.89|-0.51||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the overall study duration.|
1677953|NCT01266161|3087592|Superiority||CMH-adjusted proportion|-0.68|||<|0.021|2-Sided|95.0|-1.02|-0.35||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the fourth dosing interval.|
1677954|NCT01266161|3087592|Superiority||CMH-adjusted proportions|-0.48|||<|0.002|2-Sided|95.0|-0.9|-0.06||p-Values from the CMH test with modified ridit scores, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||For the third dosing interval.|
1677955|NCT01266161|3087592|Superiority||CMH-adjusted proportions|-0.72|||<|0.001|2-Sided|95.0|-1.05|-0.4||Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on CMH-adjusted proportions and corresponding standard errors.|Cochran-Mantel-Haenszel|||For the second dosing interval.|
1678022|NCT01265797|3087676|Superiority or Other||Mean Difference (Final Values)|0.15||||0.92|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1677957|NCT01266161|3087593|Superiority||Least squares means|5.27|||<|0.001|2-Sided|95.0|2.57|7.98||p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo from 8 to 12 hours.|
1677958|NCT01266161|3087593|Superiority||Least squares means|14.82|||<|0.001|2-Sided|95.0|10.38|19.25||p-Value from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0 to 12 hours.|
1677959|NCT01266161|3087594|Superiority||Least squares means|0.78||||0.056||95.0|-0.02|1.58||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.|
1677960|NCT01266161|3087594|Superiority||Least squares means|1.76|||<|0.001||95.0|0.97|2.54||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.|
1677961|NCT01266161|3087594|Superiority||Least squares means|1.67|||<|0.001||95.0|0.87|2.48||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.|
1677962|NCT01266161|3087594|Superiority||Least squares means|1.53|||<|0.001||95.0|0.79|2.27||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 6 hours.|
1677963|NCT01266161|3087594|Superiority||Least squares means|3.5|||<|0.001||95.0|2.67|4.33||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.|
1677964|NCT01266161|3087594|Superiority||Least squares means|3.7|||<|0.001||95.0|2.98|4.42||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.|
1677965|NCT01266161|3087594|Superiority||Least squares means|3.22|||<|0.001||95.0|2.49|3.95||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.|
1677966|NCT01266161|3087594|Superiority||Least squares means|2.43|||<|0.001||95.0|1.77|3.09||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.|
1677967|NCT01266161|3087594|Superiority||Least squares means|1.22|||<|0.001||95.0|0.69|1.74||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.|
1677968|NCT01266161|3087595|Superiority||Least squares means|0.26||||0.091||95.0|-0.04|0.56||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 48 hours.|
1677969|NCT01266161|3087595|Superiority||Least squares means|0.34||||0.036||95.0|0.02|0.67||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 44 hours.|
1677970|NCT01266161|3087595|Superiority||Least squares means|0.67|||<|0.001||95.0|0.35|1.0||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 40 hours.|
1677971|NCT01266161|3087595|Superiority||Least squares means|0.25|||<|0.127||95.0|-0.07|0.57||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 36 hours.|
1677972|NCT01266161|3087595|Superiority||Least squares means|0.62|||<|0.001||95.0|0.3|0.94||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 32 hours.|
1677973|NCT01266161|3087595|Superiority||Least squares means|0.56|||<|0.001||95.0|0.23|0.9||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 28 hours.|
1677974|NCT01266161|3087595|Superiority||Least squares means|0.04|||<|0.821||95.0|-0.28|0.35||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 24 hours.|
1677975|NCT01266161|3087595|Superiority||Least squares means|0.47|||<|0.004||95.0|0.15|0.78||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 20 hours.|
1677976|NCT01266161|3087595|Superiority||Least squares means|1.0|||<|0.001||95.0|0.7|1.29||Ibuprofen versus placebo at 0.5 hours.|ANOVA|||Ibuprofen versus placebo at 16 hours.|
1677977|NCT01266161|3087595|Superiority||Least squares means|0.27|||<|0.089||95.0|-0.04|0.59||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.|
1677978|NCT01266161|3087595|Superiority||Least squares means|0.66|||<|0.001||95.0|0.36|0.97||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.|
1677979|NCT01266161|3087595|Superiority||Least squares means|0.64|||<|0.001||95.0|0.31|0.97||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.|
1677980|NCT01266161|3087595|Superiority||Least squares means|0.61|||<|0.001||95.0|0.3|0.91||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 6 hours.|
1677981|NCT01266161|3087595|Superiority||Least squares means|1.32|||<|0.001||95.0|0.97|1.67||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.|
1677982|NCT01266161|3087595|Superiority||Least squares means|1.4|||<|0.001||95.0|1.1|1.71||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.|
1677983|NCT01266161|3087595|Superiority||Least squares means|1.22|||<|0.001||95.0|0.91|1.52||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.|
1677984|NCT01266161|3087595|Superiority||Least squares means|0.9|||<|0.001||95.0|0.63|1.18||p-Values from ANOVA model with treatment, baseline pain severity, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.|
1677985|NCT01266161|3087595|Superiority||Least squares means|0.37|||<|0.001||95.0|0.16|0.59||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.|
1677986|NCT01266161|3087596|Superiority||Least squares means|0.5||||0.052||95.0|0.0|1.01||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 12 hours.|
1677987|NCT01266161|3087596|Superiority||Least squares means|1.1|||<|0.001||95.0|0.59|1.6||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 10 hours.|
1677988|NCT01266161|3087596|Superiority||Least squares means|1.04|||<|0.001||95.0|0.54|1.54||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 8 hours.|
1677989|NCT01266161|3087596|Superiority||Least squares means|0.92|||<|0.001||95.0|0.46|1.38||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA||Treatment difference (ibuprofen minus placebo) and corresponding 95% CI were calculated based on least-squares means from the ANOVA model.|Ibuprofen versus placebo at 6 hours.|
1677990|NCT01266161|3087596|Superiority||Least squares means|2.18|||<|0.001||95.0|1.69|2.68||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 4 hours.|
1677991|NCT01266161|3087596|Superiority||Least squares means|2.29|||<|0.001||95.0|1.86|2.73||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 2 hours.|
1677992|NCT01266161|3087596|Superiority||Least squares means|2.0|||<|0.001||95.0|1.56|2.44||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1.5 hours.|
1677993|NCT01266161|3087596|Superiority||Least squares means|1.53|||<|0.001||95.0|1.11|1.94||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 1 hour.|
1677994|NCT01266161|3087596|Superiority||Least squares means|0.84|||<|0.001||95.0|0.5|1.19||p-Values from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||Ibuprofen versus placebo at 0.5 hours.|
1677995|NCT01266161|3087597|Superiority||Cox proportional hazard models|0.086||||0.011|2-Sided|95.0|0.01|0.57|||Andersen-Gill (AG)|||Time to First Dose Rescue Medication Over Entire Study Period (0-48 Hours)|
1677996|NCT01266161|3087597|Superiority||Treatment Difference|-48.01|||<|0.001||95.0|-64.42|-31.6||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the study overall (0 to 48 hours).|
1677997|NCT01266161|3087597|Superiority||Treatment Difference|-13.6|||<|0.035||95.0|-26.41|-0.79||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the fourth dosing interval (36 to 48 hours).|
1677998|NCT01266161|3087597|Superiority||Treatment Difference|-24.05|||<|0.002||95.0|-38.93|-9.18||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the third dosing interval (24 to 36 hours).|
1677999|NCT01266161|3087597|Superiority||Treatment Difference|-25.53|||<|0.001||95.0|-39.78|-11.28||p-Values from the CMH test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the second dosing interval (12 to 24 hours).|
1678000|NCT01266161|3087597|Superiority||Treatment Difference|-48.01|||<|0.001||95.0|-64.46|-31.56||p-Values from the Cochran-Mantel-Haenszel (CMH) test, controlling for baseline PSR and gender.|Cochran-Mantel-Haenszel|||During the first dosing interval (0 to 12 hours).|
1678001|NCT01266161|3087598|Superiority||Hazard Ratio (HR)|0.18|||<|0.001||95.0|0.1|0.34|||proportional hazards model||||
1678002|NCT01266161|3087599|Superiority||Least-squares means|10.97||||0.004|2-Sided|95.0|3.49|18.45||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 24-48.|
1678003|NCT01266161|3087599|Superiority||Least-squares means|2.41||||0.042|2-Sided|95.0|0.09|4.73||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 44-48.|
1678004|NCT01266161|3087599|Superiority||Least-squares means|6.09||||0.006|2-Sided|95.0|1.82|10.36||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 36-48.|
1678005|NCT01266161|3087599|Superiority||Least-squares means|3.48||||0.004|2-Sided|95.0|1.13|5.83||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 32-36.|
1678006|NCT01266161|3087599|Superiority||Least-squares means|5.87||||0.01|2-Sided|95.0|1.42|10.33||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 24-36.|
1678007|NCT01266161|3087599|Superiority||Least-squares means|14.95|||<|0.001|2-Sided|95.0|9.12|20.79||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 0-24.|
1678008|NCT01266161|3087599|Superiority||Least-squares means|2.02|||<|0.091|2-Sided|95.0|-0.33|4.37||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 20-24.|
1678009|NCT01266161|3087599|Superiority||Least-squares means|6.56|||<|0.001|2-Sided|95.0|2.84|10.27||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 12-24.|
1678010|NCT01266161|3087599|Superiority||Least-squares means|3.15|||<|0.001|2-Sided|95.0|1.45|4.85||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 8-12.|
1678011|NCT01266161|3087599|Superiority||Least-squares means|8.95|||<|0.001|2-Sided|95.0|5.94|11.95||p-Value from ANOVA model with treatment, baseline PSR, and gender terms.|ANOVA|||For SPID 0-12.|
1678012|NCT01266161|3087600|Superiority||Mean Difference (Final Values)|8.42|||<|0.001|2-Sided|95.0|4.13|12.71||p-Value from ANOVA model, with treatment, baseline PSR, and gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.|ANOVA||||
1678013|NCT01266161|3087601|Superiority||Mean Difference (Final Values)|23.76|||<|0.001|2-Sided|95.0|16.45|31.07||p-Value from analysis of variance (ANOVA) model, with treatment, baseline PSR, gender terms. To protect type I error at 5% significance, 2 primary parameters tested sequentially: SPRID 8-12 not declared significant unless SPRID 0-12 was significant.|ANOVA||||
1678014|NCT01266122|3087614|Superiority or Other||Chi-square statistic|1.39|||=|0|2-Sided||||||Chi-squared|||Intent to treat analysis.|
1678015|NCT01266122|3087615|Superiority or Other||log(Incident Risk Ratio)|-0.95|||<|0.001|2-Sided|95.0|-1.47|-0.44|||Mixed Models Analysis|Mixed effects Poisson regression||Intent to treat analysis|
1678016|NCT01266031|3087628|Superiority or Other|||||||0.26||||||Null hypothesis is: PFS 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.|Chi-squared|||Null hypothesis is: progression free survival (PFS) 6 months of Bevacizumab = PFS 6 months of Bevacizumab + Vorinostat.|
1678017|NCT01265875|3087651|Superiority or Other|||||||0.34|||||||t-test, 2 sided|||Change from baseline to Day 30.|
1678018|NCT01265875|3087651|Superiority or Other|||||||0.52|||||||t-test, 2 sided|||Change from baseline to Day 4.|
1678019|NCT01265875|3087653|Superiority or Other|||||||0.27|||||||t-test, 2 sided|||Change from baseline to Day 30.|
1678020|NCT01265875|3087653|Superiority or Other|||||||0.19|||||||t-test, 2 sided|||Change from baseline to day 7.|
1678021|NCT01265875|3087653|Superiority or Other|||||||0.25|||||||t-test, 2 sided|||Change from baseline to day 4.|
1678024|NCT01265797|3087678|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.87|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1678025|NCT01265797|3087679|Superiority or Other||Mean Difference (Net)|0.05||||0.97|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1678026|NCT01265797|3087680|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.98|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1678027|NCT01265797|3087681|Superiority or Other||Mean Difference (Final Values)|-2.74||||0.02|2-Sided|||||Change in mean anxiety score/ 14 day recall from the blinded period to open label period|Wilcoxon (Mann-Whitney)||||
1678028|NCT01265797|3087682|Superiority or Other||Mean Difference (Final Values)|0.6||||0.73|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1678029|NCT01265797|3087683|Superiority or Other||Mean Difference (Final Values)|0.91||||0.75|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1678030|NCT01265797|3087684|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.98|2-Sided||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare the primary and secondary outcome measures between the two treatment groups.||The a priori alpha level was set at p < 0.05, and beta 0.2. Assuming that 20% of persons with the sham device and 60% of persons with CES device will meet the primary end point of ≥50% decrease in the frequency of headache days over the course of the study, 27 subjects are enrolled per group. The null hypothesis: No difference in the depression score/14 day recall between the two groups.|
1678031|NCT01265797|3087685|Superiority or Other||Mean Difference (Final Values)|0.96||||0.3|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1678032|NCT01265797|3087686|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.89|2-Sided||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare secondary outcome measures between two treatment groups in the run-in month minus open label month|||
1678033|NCT01265797|3087687|Superiority or Other||Mean Difference (Final Values)|1.4||||0.3|2-Sided||||||Wilcoxon (Mann-Whitney)|The Mann-Whitney U test was used to compare outcome measures between two treatment groups in the run-in month minus blinded month||The a priori alpha level was set at p < 0.05, and a power of 0.80 (80%) was used to compute the number of subjects needed to find a meaningful difference between the verum and sham groups. Assuming that 20% of persons with the sham device and 60% of persons with CES device will meet the primary end point of ≥50% decrease in the frequency of headache days over the course of the study, 27 subjects are enrolled per group.|
1678034|NCT01265719|3087711|Superiority or Other||Difference in percentage|4.5||||0.2413|2-Sided|95.0|-10.49|19.36|||Fisher Exact||||
1678035|NCT01265719|3087712|Superiority or Other||LS Mean difference|-0.87|Standard Error of the Mean|4.87||0.8591|2-Sided|95.0|-10.54|8.8|||ANCOVA||Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.|5 to <18 years|
1678036|NCT01265719|3087712|Superiority or Other||LS Mean difference|-2.68|Standard Error of the Mean|15.54||0.8643|2-Sided|95.0|-34.3|28.94|||ANCOVA||Change from baseline to last available observation in corneal thickness was analyzed using an ANCOVA model with fixed effect for treatment group with baseline corneal thickness value as covariate.|<5 years|
1678037|NCT01265719|3087713|Superiority or Other||LS Mean difference|-0.21|Standard Error of the Mean|0.32||0.5199|2-Sided|95.0|-0.85|0.43|||ANCOVA||Change from baseline to last available observation in LLL was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.|5 to <18 years|
1678038|NCT01265719|3087713|Superiority or Other||LS Mean difference|0.61|Standard Error of the Mean|0.52||0.2437|2-Sided|95.0|-0.43|1.65|||ANCOVA||Change from baseline to last available observation in longest lash length (LLL) was analyzed using an ANCOVA model with fixed effect for treatment group with baseline LLL value as covariate.|<5 years|
1678039|NCT01265719|3087714|Superiority or Other||Difference in percentage|1.6||||0.6414|2-Sided|95.0|-13.39|16.48|||Fisher Exact||||
1678040|NCT01265719|3087716|Superiority or Other||Difference in percentage|1.2|||>|0.999|2-Sided|95.0|-13.78|16.09|||Fisher Exact||||
1678041|NCT01265719|3087717|Superiority or Other||Difference in percentage|-0.4|||>|0.999|2-Sided|95.0|-15.32|14.55|||Fisher Exact||||
1678042|NCT01265719|3087718|Superiority or Other||Difference in percentage|1.0|||>|0.999|2-Sided|95.0|-13.97|15.9|||Fisher Exact||||
1678043|NCT01265719|3087719|Superiority or Other||LS Mean difference|-6.66|Standard Error of the Mean|2.41||0.0184|2-Sided|95.0|-11.95|-1.36|||ANCOVA|The results were interpreted with caution because of the very small sample size of non-PG treatment group (n=4).|Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|5 to <18 years (IOP ≥21mmHg at Baseline)|
1678044|NCT01265719|3087719|Superiority or Other||LS Mean difference|-0.1|Standard Error of the Mean|0.75||0.894|2-Sided|95.0|-1.59|1.39|||ANCOVA||Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|5 to <18 years (IOP <21mmHg at Baseline)|
1678045|NCT01265719|3087719|Superiority or Other||LS Mean difference|-1.62|Standard Error of the Mean|1.25||0.2003|2-Sided|95.0|-4.13|0.89|||ANCOVA||Change from baseline to last available observation in IOP was analyzed using an ANCOVA model with fixed effect for treatment group with baseline IOP value as covariate.|<5 years|
1678046|NCT01265719|3087720|Superiority or Other||LS Mean difference|0.03|Standard Error of the Mean|0.2||0.8826|2-Sided|95.0|-0.37|0.43|||ANCOVA||Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.|5 to <18 years|
1678047|NCT01265719|3087720|Superiority or Other||LS Mean difference|-0.04|Standard Error of the Mean|0.3||0.902|2-Sided|95.0|-0.63|0.56|||ANCOVA||Change from baseline to last available observation in HCD was analyzed using an ANCOVA model with fixed effect for treatment group with baseline HCD value as covariate.|<5 years|
1678048|NCT01265719|3087722|Superiority or Other||LS Mean difference|-0.03|Standard Error of the Mean|0.04||0.484|2-Sided|95.0|-0.12|0.06|||ANCOVA||Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.|5 to <18 years|
1678078|NCT01265498|3087832|Superiority or Other||Mean Difference (Net)|-0.5||||0.13|2-Sided|95.0|-1.2|0.2|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678049|NCT01265719|3087722|Superiority or Other||LS Mean difference|0.33|Standard Error of the Mean|0.2||0.1126|2-Sided|95.0|-0.09|0.74|||ANCOVA||Change from baseline to last available observation in BCVA was analyzed using an ANCOVA model with fixed effect for treatment group with baseline BCVA value as covariate.|<5 years|
1678050|NCT01265615|3087727|Superiority or Other||||||<|0.05|||||||ANOVA||||
1678051|NCT01265615|3087728|Superiority or Other||||||<|0.05|||||||ANOVA||||
1678052|NCT01265615|3087729|Superiority or Other||||||<|0.05|||||||ANOVA||||
1678053|NCT01265615|3087730|Superiority or Other||||||<|0.05|||||||ANOVA||||
1678054|NCT01265615|3087731|Superiority or Other||||||<|0.05|||||||ANOVA||||
1678055|NCT01265615|3087732|Superiority or Other||||||<|0.05|||||||ANOVA||||
1678056|NCT01265615|3087733|Superiority or Other||||||<|0.05|||||||ANOVA||||
1678057|NCT01265615|3087734|Superiority or Other||||||<|0.05|||||||ANOVA||||
1678058|NCT01265615|3087735|Superiority or Other||||||<|0.05|||||||ANOVA||||
1678059|NCT01265615|3087736|Superiority or Other||||||<|0.05|||||||ANOVA||||
1678060|NCT01265524|3087806|Non-Inferiority or Equivalence|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.072||||||Corrections for multiplicity were not performed and P values < 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.|||
1678061|NCT01265524|3087807|Non-Inferiority or Equivalence|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.0002||||||Corrections for multiplicity were not performed and P values < 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.|||
1678062|NCT01265524|3087811|Non-Inferiority or Equivalence|The efficacy and the safety analyses were done using the ITT population with Week 8/EOS data for the patients who did not complete the 8-week treatment period excluded. The ITT population included all randomized patients who received at least 1 dose of study drug.||||||0.014||||||Corrections for multiplicity were not performed and P values < 0.05 were considered statistically significant.|ANCOVA|Continuous or ordinal data were analyzed using RM-ANCOVA using change from baseline values to compare CLP and placebo treatments.|||
1678063|NCT01265498|3087817|Superiority or Other||Mean Difference (Net)|0.0||||0.65|2-Sided|95.0|-3.0|2.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678064|NCT01265498|3087818|Superiority or Other||Mean Difference (Net)|1.0||||0.22|2-Sided|95.0|-1.0|3.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678065|NCT01265498|3087819|Superiority or Other||Mean Difference (Net)|-1.0||||0.23|2-Sided|95.0|-4.0|1.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678066|NCT01265498|3087820|Superiority or Other||Mean Difference (Net)|-3.0||||0.05|2-Sided|95.0|-7.0|0.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678067|NCT01265498|3087821|Superiority or Other||Mean Difference (Net)|0.0||||0.57|2-Sided|95.0|-0.01|0.02|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678068|NCT01265498|3087822|Superiority or Other||Mean Difference (Net)|-0.4||||0.7|2-Sided|95.0|-2.2|1.5|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678069|NCT01265498|3087823|Superiority or Other||Mean Difference (Net)|-0.7||||0.01|2-Sided|95.0|-1.3|-0.2|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678070|NCT01265498|3087824|Superiority or Other||Mean Difference (Net)|-2.2||||0.008|2-Sided|95.0|-3.7|-0.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678071|NCT01265498|3087825|Superiority or Other||Mean Difference (Net)|0.4||||0.71|2-Sided|95.0|-1.7|2.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678072|NCT01265498|3087826|Superiority or Other||Mean Difference (Net)|13.0||||0.01|2-Sided|95.0|3.0|23.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678073|NCT01265498|3087827|Superiority or Other||Mean Difference (Net)|38.0||||0.02|2-Sided|95.0|6.0|69.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678074|NCT01265498|3087828|Superiority or Other||Mean Difference (Net)|0.3||||0.26|2-Sided|95.0|-0.2|0.8|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678075|NCT01265498|3087829|Superiority or Other||Mean Difference (Net)|-0.02||||0.002|2-Sided|95.0|-0.04|-0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678076|NCT01265498|3087830|Superiority or Other||Mean Difference (Net)|-0.2||||0.16|2-Sided|95.0|-0.6|0.1|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678077|NCT01265498|3087831|Superiority or Other||Mean Difference (Net)|0.5||||0.31|2-Sided|95.0|-0.5|1.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678079|NCT01265498|3087833|Superiority or Other||Mean Difference (Net)|14.0||||0.05|2-Sided|95.0|0.0|29.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678080|NCT01265498|3087834|Superiority or Other||Mean Difference (Net)|2.6||||0.03|2-Sided|95.0|0.2|5.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678081|NCT01265498|3087835|Superiority or Other||Mean Difference (Net)|0.01||||0.53|2-Sided|95.0|-0.03|0.05|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678082|NCT01265498|3087836|Superiority or Other||Mean Difference (Net)|0.02||||0.04|2-Sided|95.0|0.0|0.04|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678083|NCT01265498|3087837|Superiority or Other||Mean Difference (Net)|-0.7||||0.03|2-Sided|95.0|-1.4|-0.1|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678084|NCT01265498|3087838|Superiority or Other||Mean Difference (Net)|16.0||||0.001|2-Sided|95.0|7.0|26.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678085|NCT01265498|3087839|Superiority or Other||Mean Difference (Net)|0.1||||0.4|2-Sided|95.0|-0.2|0.4|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678086|NCT01265498|3087840|Superiority or Other||Mean Difference (Net)|-1.1||||0.002|2-Sided|95.0|-1.8|-0.4|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678087|NCT01265498|3087841|Superiority or Other||Mean Difference (Net)|0.0||||0.71|2-Sided|95.0|-0.01|0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678088|NCT01265498|3087842|Superiority or Other||Mean Difference (Net)|0.4||||0.72|2-Sided|95.0|-1.8|2.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678089|NCT01265498|3087843|Superiority or Other||Mean Difference (Net)|-0.02||||0.88|2-Sided|95.0|-0.35|0.3|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678090|NCT01265498|3087844|Superiority or Other||Mean Difference (Net)|0.45|||<|0.0001|2-Sided|95.0|0.26|0.65|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678091|NCT01265498|3087845|Superiority or Other||Mean Difference (Net)|-0.06||||0.01|2-Sided|95.0|-0.1|-0.01|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678092|NCT01265498|3087846|Superiority or Other||Mean Difference (Net)|0.38||||0.0009|2-Sided|95.0|0.16|0.6|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678093|NCT01265498|3087847|Superiority or Other||Mean Difference (Net)|-1.5||||0.002|2-Sided|95.0|-2.4|-0.5|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678094|NCT01265498|3087848|Superiority or Other||Mean Difference (Net)|-24.0|||<|0.0001|2-Sided|95.0|-35.0|-14.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678095|NCT01265498|3087849|Superiority or Other||Mean Difference (Net)|18.0|||<|0.0001|2-Sided|95.0|13.0|24.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678096|NCT01265498|3087850|Superiority or Other||Mean Difference (Net)|-12.0||||0.0001|2-Sided|95.0|-18.0|-6.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678097|NCT01265498|3087851|Superiority or Other||Mean Difference (Net)|-20.0|||<|0.0001|2-Sided|95.0|-28.0|-11.0|||ANCOVA|calculated using ANCOVA models, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678098|NCT01265498|3087852|Superiority or Other||Mean Difference (Net)|0.0||||0.59|2-Sided|95.0|-0.1|0.2|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678099|NCT01265498|3087853|Superiority or Other||Risk Ratio (RR)|1.0||||0.9|2-Sided|95.0|0.6|1.7|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo||
1678100|NCT01265498|3087854|Superiority or Other||Mean Difference (Net)|-0.3||||0.0006|2-Sided|95.0|-0.5|-0.1|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678101|NCT01265498|3087855|Superiority or Other||Risk Ratio (RR)|1.6||||0.006|2-Sided|95.0|1.1|2.2|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo||
1678102|NCT01265498|3087856|Superiority or Other||Mean Difference (Net)|-0.4||||0.0004|2-Sided|95.0|-0.6|-0.2|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678103|NCT01265498|3087857|Superiority or Other||Risk Ratio (RR)|1.7||||0.001|2-Sided|95.0|1.2|2.3|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs. placebo||
1678218|NCT01263496|3088072|Superiority or Other||Mean Difference (Final Values)|15.891|||||2-Sided|95.0|9.597|22.184|||||||
1678104|NCT01265498|3087858|Superiority or Other||Mean Difference (Net)|-0.2||||0.03|2-Sided|95.0|-0.5|0.0|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678105|NCT01265498|3087859|Superiority or Other||Risk Ratio (RR)|1.5||||0.03|2-Sided|95.0|1.0|2.1|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo||
1678106|NCT01265498|3087860|Superiority or Other||Mean Difference (Net)|-0.9|||<|0.0001|2-Sided|95.0|-1.3|-0.5|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678107|NCT01265498|3087861|Superiority or Other||Mean Difference (Net)|-0.3||||0.01|2-Sided|95.0|-0.6|-0.1|||ANCOVA|calculated using ANCOVA, regressing change from baseline to 72 weeks on treatment group and baseline value of the outcome|obeticholic acid vs placebo||
1678108|NCT01265498|3087862|Superiority or Other||Risk Ratio (RR)|1.8||||0.004|2-Sided|95.0|1.1|2.7|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo||
1678109|NCT01265498|3087863|Superiority or Other||Risk Ratio (RR)|1.5||||0.08|2-Sided|95.0|0.9|2.6|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status|obeticholic acid vs placebo||
1678110|NCT01265498|3087864|Superiority or Other||Risk Ratio (RR)|1.9||||0.0002|2-Sided|95.0|1.3|2.8|||Cochran-Mantel-Haenszel|p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status.|obeticholic acid vs placebo||
1678111|NCT01265056|3087875|Superiority|||||||0.8|||||||t-test, 2 sided||||
1678112|NCT01265056|3087876|Superiority||||||<|0.8|||||||t-test, 2 sided||||
1678113|NCT01265056|3087877|Superiority||||||<|0.04|||||||Regression, Logistic||||
1678114|NCT01265056|3087877|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1678115|NCT01264939|3087882|Superiority or Other||||||<|0.0001||||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1678116|NCT01264939|3087883|Superiority or Other|||||||0.0006||||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Stratified Wilcoxon|Stratification variables included in the analysis were presence of angioedema at baseline (yes vs no) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1678117|NCT01264939|3087884|Superiority or Other||Least squares mean difference|-4.67|||<|0.0001|2-Sided|95.0|-6.28|-3.06||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline overall DLQI score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1678118|NCT01264939|3087885|Superiority or Other||Least squares mean difference|-5.61|||<|0.0001|2-Sided|95.0|-7.25|-3.96||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly size of largest hive score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1678119|NCT01264939|3087886|Superiority or Other||||||<|0.0001||||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1678120|NCT01264939|3087887|Superiority or Other||||||<|0.0001||||||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cochran-Mantel-Haenszel|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1678121|NCT01264939|3087888|Superiority or Other||Hazard Ratio (HR)|1.99|||<|0.0001|2-Sided|95.0|1.47|2.68||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|Cox proportional hazards model|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1678122|NCT01264939|3087889|Superiority or Other||Least squares mean difference|-5.9|||<|0.0001|2-Sided|95.0|-7.72|-4.07||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly number of hives score (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1678123|NCT01264939|3087890|Superiority or Other||Least squares mean difference|-10.02|||<|0.0001|2-Sided|95.0|-13.17|-6.86||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline UAS7 (< median vs ≥ median) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1681978|NCT01221597|3093901|Superiority or Other|||||||0.0268|||||||ANOVA||||
1678124|NCT01264939|3087891|Superiority or Other||Least squares mean difference|-4.52|||<|0.0001|2-Sided|95.0|-5.97|-3.08||Multiplicity plan applied to the efficacy endpoints provided strong control of the type I error rate at 0.05 level by pre-specifying the hierarchical order of the efficacy endpoint tests.|ANCOVA|Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg).||The null hypothesis was that there was no difference between the placebo and the omalizumab 300 mg groups.|
1678125|NCT01264770|3087901|Superiority or Other||Treatment difference|-2.48||||0.16|2-Sided|90.0|-5.38|0.43|||ANCOVA|Includes terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678126|NCT01264770|3087901|Superiority or Other||Treatment difference|-1.66||||0.368|2-Sided|90.0|-4.69|1.38|||ANCOVA|Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678127|NCT01264770|3087901|Superiority or Other||Treatment difference|-1.02||||0.568|2-Sided|90.0|-3.95|1.92|||ANCOVA|Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678128|NCT01264770|3087902|Superiority or Other||Treatment difference|-2.99||||0.032|2-Sided|90.0|-5.29|-0.7|||ANCOVA|Includes terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678129|NCT01264770|3087902|Superiority or Other||Treatment difference|-1.33||||0.36|2-Sided|90.0|-3.73|1.06|||ANCOVA|Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678130|NCT01264770|3087902|Superiority or Other||Treatment difference|-2.77||||0.05|2-Sided|90.0|-5.08|-0.45|||ANCOVA|Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678131|NCT01264770|3087903|Superiority or Other||Treatment difference|-0.32||||0.001|2-Sided|90.0|-0.47|-0.16|||ANCOVA|Includes terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678132|NCT01264770|3087903|Superiority or Other||Treatment difference|-0.14||||0.158|2-Sided|90.0|-0.31|0.02|||ANCOVA|Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678133|NCT01264770|3087903|Superiority or Other||Treatment difference|-0.2||||0.043|2-Sided|90.0|-0.36|-0.04|||ANCOVA|Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678134|NCT01264770|3087904|Superiority or Other||Treatment difference|0.14||||0.094|2-Sided|90.0|0.0|0.29|||ANCOVA|Includes terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678135|NCT01264770|3087904|Superiority or Other||Treatment difference|0.22||||0.016|2-Sided|90.0|0.07|0.37|||ANCOVA|Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678136|NCT01264770|3087904|Superiority or Other||Treatment difference|0.24||||0.007|2-Sided|90.0|0.09|0.38|||ANCOVA|Including terms for baseline as a continuous covariate & treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) & pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678137|NCT01264770|3087905|Superiority or Other||Treatment difference|-19.53||||0.002|2-Sided|90.0|-30.01|-6.25|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678138|NCT01264770|3087905|Superiority or Other||Treatment difference|-9.49||||0.207|2-Sided|90.0|-25.0|6.96|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678219|NCT01263496|3088073|Superiority or Other||Mean Difference (Final Values)|1.263|||||2-Sided|95.0|0.674|1.853|||||||
1678220|NCT01263496|3088073|Superiority or Other||Mean Difference (Final Values)|0.992|||||2-Sided|95.0|0.4|1.585|||||||
1678139|NCT01264770|3087905|Superiority or Other||Treatment difference|-13.72||||0.03|2-Sided|90.0|-25.01|0.0|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678140|NCT01264770|3087906|Superiority or Other||Treatment difference|5.72||||0.234|2-Sided|90.0|-3.2|21.68|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678141|NCT01264770|3087906|Superiority or Other||Treatment difference|22.97||||0.006|2-Sided|90.0|7.84|38.34|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678142|NCT01264770|3087906|Superiority or Other||Treatment difference|23.39|||<|0.001|2-Sided|90.0|9.57|40.0|||Van Elteren|Estimated using the Van Elteren test stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678143|NCT01264770|3087907|Superiority or Other||Weighted difference in proportions|-0.17||||0.002|2-Sided|90.0|-0.27|-0.08||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678144|NCT01264770|3087907|Superiority or Other||Weighted difference in proportions|-0.11||||0.092|2-Sided|90.0|-0.21|0.0||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678145|NCT01264770|3087907|Superiority or Other||Weighted difference in proportions|-0.11||||0.082|2-Sided|90.0|-0.21|-0.01||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678146|NCT01264770|3087907|Superiority or Other||Weighted difference in proportions|-0.03||||0.172|2-Sided|90.0|-0.08|0.01||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678147|NCT01264770|3087907|Superiority or Other||Weighted difference in proportions|0.0||||0.903|2-Sided|90.0|-0.05|0.06||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678148|NCT01264770|3087907|Superiority or Other||Weighted difference in proportions|-0.02||||0.46|2-Sided|90.0|-0.07|0.03||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678149|NCT01264770|3087908|Superiority or Other||Weighted difference in proportions|-0.21||||0.003|2-Sided|90.0|-0.32|-0.09||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678150|NCT01264770|3087908|Superiority or Other||Weighted difference in proportions|-0.14||||0.078|2-Sided|90.0|-0.26|-0.01||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678163|NCT01264770|3087910|Superiority or Other||Odds Ratio (OR)|0.37||||0.007|2-Sided|90.0|0.2|0.68|||Proportional odds model||An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678221|NCT01263496|3088073|Superiority or Other||Mean Difference (Final Values)|1.304|||||2-Sided|95.0|0.679|1.93|||||||
1678151|NCT01264770|3087908|Superiority or Other||Weighted difference in proportions|-0.12||||0.114|2-Sided|90.0|-0.24|0.0||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678152|NCT01264770|3087908|Superiority or Other||Weighted difference in proportions|0.01||||0.758|2-Sided|90.0|-0.05|0.07||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678153|NCT01264770|3087908|Superiority or Other||Weighted difference in proportions|0.09||||0.071|2-Sided|90.0|0.01|0.17||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678154|NCT01264770|3087908|Superiority or Other||Weighted difference in proportions|0.09||||0.059|2-Sided|90.0|0.01|0.18||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678155|NCT01264770|3087909|Superiority or Other||Weighted difference in proportions|-0.24||||0.003|2-Sided|90.0|-0.37|-0.1||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678156|NCT01264770|3087909|Superiority or Other||Weighted difference in proportions|-0.02||||0.803|2-Sided|90.0|-0.16|0.12||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678157|NCT01264770|3087909|Superiority or Other||Weighted difference in proportions|-0.16||||0.049|2-Sided|90.0|-0.3|-0.03||Week 24|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678158|NCT01264770|3087909|Superiority or Other||Weighted difference in proportions|0.19||||0.007|2-Sided|90.0|0.07|0.31||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678159|NCT01264770|3087909|Superiority or Other||Weighted difference in proportions|0.3|||<|0.001|2-Sided|90.0|0.18|0.43||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678160|NCT01264770|3087909|Superiority or Other||Weighted difference in proportions|0.29|||<|0.001|2-Sided|90.0|0.17|0.4||Week 6|Mantel Haenszel|p-values are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|90% confidence intervals are calculated using a Mantel-Haenszel approach stratified by DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678161|NCT01264770|3087910|Superiority or Other||Odds Ratio (OR)|0.36||||0.004|2-Sided|90.0|0.2|0.65|||Proportional odds model||An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678162|NCT01264770|3087910|Superiority or Other||Odds Ratio (OR)|0.48||||0.051|2-Sided|90.0|0.26|0.89|||Proportional odds model||An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678215|NCT01263496|3088072|Superiority or Other||Mean Difference (Final Values)|15.368|||||2-Sided|95.0|8.677|22.06|||||||
1678216|NCT01263496|3088072|Superiority or Other||Mean Difference (Final Values)|19.838|||||2-Sided|95.0|14.379|25.297|||||||
1678164|NCT01264770|3087911|Superiority or Other||Odds Ratio (OR)|1.47||||0.335|2-Sided|90.0|0.76|2.83|||Proportional odds model||An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678165|NCT01264770|3087911|Superiority or Other||Odds Ratio (OR)|4.11|||<|0.001|2-Sided|90.0|2.1|8.05|||Proportional odds model||An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678166|NCT01264770|3087911|Superiority or Other||Odds Ratio (OR)|3.05|||<|0.005|2-Sided|90.0|1.59|5.86|||Proportional odds model||An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1678167|NCT01264770|3087912|Non-Inferiority or Equivalence|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.72||||0.004|2-Sided|80.0|-1.04|-0.4|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.|
1678168|NCT01264770|3087912|Non-Inferiority or Equivalence|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.61||||0.02|2-Sided|80.0|-0.94|-0.27|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.|
1678169|NCT01264770|3087912|Non-Inferiority or Equivalence|For the comparison with adalimumab a non-inferiority margin of -0.6 in the mean change from baseline in DAS28-CRP at Week 24 was defined. The lower 80% confidence interval for treatment difference was below this value so non-inferiority could not be concluded. A p-value is also provided for a 2-sided test of superiority.|Treatment difference|-0.72||||0.005|2-Sided|80.0|-1.04|-0.4|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 24. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.|
1678170|NCT01264770|3087913|Superiority or Other||Treatment difference|0.22||||0.28|2-Sided|90.0|-0.12|0.56|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.|
1678171|NCT01264770|3087913|Superiority or Other||Treatment difference|0.49||||0.022|2-Sided|90.0|0.14|0.84|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.|
1678172|NCT01264770|3087913|Superiority or Other||Treatment difference|0.56||||0.006|2-Sided|90.0|0.23|0.9|||ANCOVA|Includes terms for baseline as a continuous covariate and treatment, DMARD naivety (DMARD naive vs DMARD-IR/intolerant) and pooled country as factors.||Change from baseline at Week 6. Non-responder imputation applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of parenteral steroids, or for patients with no post baseline data.|
1678173|NCT01264718|3087914|Other|The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.|ICER|4.0|||||2-Sided||||||||The estimated value is the savings for each percent increase in children obtaining insurance per year.||
1678174|NCT01264718|3087914|Other|The Intervention Cost-Effectiveness Ratio (ICER) is the difference in total costs between the intervention group and controls was divided by the intergroup difference in the proportion of insured children.|ICER|6.0|||||2-Sided||||||||The estimated value is the savings per child per year insured.||
1678175|NCT01264380|3087937|Superiority or Other||Ratio of Geometric Mean|2.45|||||2-Sided|90.0|1.81|3.32||||||The point estimate and 90% CI of vemurafenib plasma Cmax geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.|
1678176|NCT01264380|3087938|Superiority or Other||Ratio of Geometric Mean|5.05|||||2-Sided|90.0|2.99|8.55||||||The point estimate and 90% CI of vemurafenib plasma AUC geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.|
1678177|NCT01264380|3087939|Superiority or Other||Ratio of Geometric Mean|4.64|||||2-Sided|90.0|2.83|7.6||||||The point estimate and 90 percent (%) confidence interval (CI) of vemurafenib plasma AUC geometric means ratios of the Fed to Fasted conditions following an oral administration of a single dose of 960 mg vemurafenib were analyzed.|
1678178|NCT01263938|3087945|Other|||||||0.625||||||Threshold for statistical significance: p<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.|
1678217|NCT01263496|3088072|Superiority or Other||Mean Difference (Final Values)|18.026|||||2-Sided|95.0|12.466|23.585|||||||
1678179|NCT01263938|3087946|Other|||||||0.813||||||Threshold for statistical significance: p<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.|
1678180|NCT01263938|3087947|Other||||||>|0.999||||||Threshold for statistical significance: p<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.|
1678181|NCT01263938|3087948|Other||||||>|0.999||||||Threshold for statistical significance: p<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.|
1678182|NCT01263938|3087948|Other||||||>|0.813||||||Threshold for statistical significance: p<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.|
1678183|NCT01263938|3087948|Other||||||>|0.625||||||Threshold for statistical significance: p<0.05|Wilcoxon signed rank|||Sample size calculations were based on having sufficient power to detect a change in each of the outcome variables from baseline to week 12.The effect size was calculated as (detectable difference in change in outcome) / (SD of the change). Based on preliminary in vitro data, the smallest effect size was 1.88. Assuming that only 40% of this effect will be present in vivo (effect size=0.75), alpha = 0.05 and 80% power, n=16 is needed to complete the study.|
1678184|NCT01263561|3088002|Non-Inferiority or Equivalence|Power calculation only performed for main outcome measure of IOP.||||||0.8||||||Above p is for number of subjects with any complication. P values above 0.05 are considered statistically insignificant in this study.|Chi-squared||||
1678185|NCT01263561|3088003|Non-Inferiority or Equivalence|Power calculation only for main outcome measure of IOP.||||||0.24|||||||Kaplan Meier||||
1678186|NCT01263561|3088004|Non-Inferiority or Equivalence|A sample size calculation determined that 52 eyes were required to detect a 2.0 mmHg IOP difference with a power of 80%.||||||0.85|||||||t-test, 2 sided||||
1678187|NCT01263496|3088065|Superiority or Other||Mean Difference (Final Values)|-0.68|||||2-Sided|95.0|-17.24|15.89|||||||
1678188|NCT01263496|3088065|Superiority or Other||Mean Difference (Final Values)|3.65|||||2-Sided|95.0|-14.42|21.73|||||||
1678189|NCT01263496|3088065|Superiority or Other||Mean Difference (Final Values)|4.94|||||2-Sided|95.0|-11.14|21.03|||||||
1678190|NCT01263496|3088065|Superiority or Other||Mean Difference (Final Values)|4.08|||||2-Sided|95.0|-11.7|19.86|||||||
1678191|NCT01263496|3088066|Superiority or Other||Mean Difference (Final Values)|1.29|||||2-Sided|95.0|-17.47|20.05|||||||
1678192|NCT01263496|3088066|Superiority or Other||Mean Difference (Final Values)|-0.66|||||2-Sided|95.0|-21.0|19.68|||||||
1678193|NCT01263496|3088066|Superiority or Other||Mean Difference (Final Values)|2.48|||||2-Sided|95.0|-15.61|20.57|||||||
1678194|NCT01263496|3088066|Superiority or Other||Mean Difference (Final Values)|3.09|||||2-Sided|95.0|-14.95|21.13|||||||
1678195|NCT01263496|3088067|Superiority or Other||Mean Difference (Final Values)|6.82|||||2-Sided|95.0|-10.67|24.3|||||||
1678196|NCT01263496|3088067|Superiority or Other||Mean Difference (Final Values)|8.45|||||2-Sided|95.0|-10.08|26.98|||||||
1678197|NCT01263496|3088067|Superiority or Other||Mean Difference (Final Values)|10.57|||||2-Sided|95.0|-7.21|28.35|||||||
1678198|NCT01263496|3088067|Superiority or Other||Mean Difference (Final Values)|5.9|||||2-Sided|95.0|-11.11|22.91|||||||
1678199|NCT01263496|3088068|Superiority or Other||Mean Difference (Final Values)|0.82|||||2-Sided|95.0|-13.26|14.9|||||||
1678200|NCT01263496|3088068|Superiority or Other||Mean Difference (Final Values)|9.72|||||2-Sided|95.0|-5.12|24.56|||||||
1678201|NCT01263496|3088068|Superiority or Other||Mean Difference (Final Values)|11.85|||||2-Sided|95.0|-1.49|25.19|||||||
1678202|NCT01263496|3088068|Superiority or Other||Mean Difference (Final Values)|6.76|||||2-Sided|95.0|-7.03|20.55|||||||
1678203|NCT01263496|3088069|Superiority or Other||Mean Difference (Final Values)|13.087|||||2-Sided|95.0|6.561|19.614|||||||
1678204|NCT01263496|3088069|Superiority or Other||Mean Difference (Final Values)|15.076|||||2-Sided|95.0|9.808|20.345|||||||
1678205|NCT01263496|3088069|Superiority or Other||Mean Difference (Final Values)|12.978|||||2-Sided|95.0|7.556|18.399|||||||
1678206|NCT01263496|3088069|Superiority or Other||Mean Difference (Final Values)|7.719|||||2-Sided|95.0|1.657|13.782|||||||
1678207|NCT01263496|3088070|Superiority or Other||Mean Difference (Final Values)|13.366|||||2-Sided|95.0|5.847|20.885|||||||
1678208|NCT01263496|3088070|Superiority or Other||Mean Difference (Final Values)|15.221|||||2-Sided|95.0|9.191|21.251|||||||
1678209|NCT01263496|3088070|Superiority or Other||Mean Difference (Final Values)|13.95|||||2-Sided|95.0|7.767|20.133|||||||
1678210|NCT01263496|3088070|Superiority or Other||Mean Difference (Final Values)|8.047|||||2-Sided|95.0|1.169|14.924|||||||
1678211|NCT01263496|3088071|Superiority or Other||Mean Difference (Final Values)|15.233|||||2-Sided|95.0|6.618|23.847|||||||
1678212|NCT01263496|3088071|Superiority or Other||Mean Difference (Final Values)|19.063|||||2-Sided|95.0|13.125|25.002|||||||
1678213|NCT01263496|3088071|Superiority or Other||Mean Difference (Final Values)|20.714|||||2-Sided|95.0|14.563|26.864|||||||
1678214|NCT01263496|3088071|Superiority or Other||Mean Difference (Final Values)|14.323|||||2-Sided|95.0|6.567|22.079|||||||
1678222|NCT01263496|3088073|Superiority or Other||Mean Difference (Final Values)|0.841|||||2-Sided|95.0|0.239|1.443|||||||
1678223|NCT01263496|3088074|Superiority or Other||Mean Difference (Final Values)|1.277|||||2-Sided|95.0|-2.191|4.744|||||||
1678224|NCT01263496|3088074|Superiority or Other||Mean Difference (Final Values)|0.517|||||2-Sided|95.0|-8.151|9.184|||||||
1678225|NCT01263496|3088074|Superiority or Other||Mean Difference (Final Values)|1.585|||||2-Sided|95.0|-3.476|6.647|||||||
1678226|NCT01263496|3088074|Superiority or Other||Mean Difference (Final Values)|0.05|||||2-Sided|95.0|-4.088|4.188|||||||
1678227|NCT01263496|3088075|Superiority or Other||Mean Difference (Final Values)|1.481|||||2-Sided|95.0|0.827|2.136|||||||
1678228|NCT01263496|3088075|Superiority or Other||Mean Difference (Final Values)|1.243|||||2-Sided|95.0|0.616|1.87|||||||
1678229|NCT01263496|3088075|Superiority or Other||Mean Difference (Final Values)|1.448|||||2-Sided|95.0|0.78|2.115|||||||
1678230|NCT01263496|3088075|Superiority or Other||Mean Difference (Final Values)|1.034|||||2-Sided|95.0|0.344|1.723|||||||
1678231|NCT01263496|3088076|Superiority or Other||Mean Difference (Final Values)|1.38|||||2-Sided|95.0|0.804|1.955|||||||
1678232|NCT01263496|3088076|Superiority or Other||Mean Difference (Final Values)|1.35|||||2-Sided|95.0|0.724|1.975|||||||
1678233|NCT01263496|3088076|Superiority or Other||Mean Difference (Final Values)|1.358|||||2-Sided|95.0|0.752|1.965|||||||
1678234|NCT01263496|3088076|Superiority or Other||Mean Difference (Final Values)|0.955|||||2-Sided|95.0|0.375|1.535|||||||
1678235|NCT01263496|3088077|Superiority or Other||Mean Difference (Final Values)|-34.9|||||2-Sided|95.0|-56.85|-12.96|||||||
1678236|NCT01263496|3088077|Superiority or Other||Mean Difference (Final Values)|-11.2|||||2-Sided|95.0|-32.69|10.3|||||||
1678237|NCT01263496|3088077|Superiority or Other||Mean Difference (Final Values)|1.37|||||2-Sided|95.0|-21.21|23.94|||||||
1678238|NCT01263496|3088077|Superiority or Other||Mean Difference (Final Values)|2.97|||||2-Sided|95.0|-18.77|24.71|||||||
1678239|NCT01263496|3088078|Superiority or Other||Mean Difference (Final Values)|-23.37|||||2-Sided|95.0|-47.08|0.34|||||||
1678240|NCT01263496|3088078|Superiority or Other||Mean Difference (Final Values)|-3.64|||||2-Sided|95.0|-26.03|18.74|||||||
1678241|NCT01263496|3088078|Superiority or Other||Mean Difference (Final Values)|3.35|||||2-Sided|95.0|-18.2|24.9|||||||
1678242|NCT01263496|3088078|Superiority or Other||Mean Difference (Final Values)|5.84|||||2-Sided|95.0|-13.9|25.58|||||||
1678243|NCT01263496|3088079|Superiority or Other||Mean Difference (Final Values)|-12.8|||||2-Sided|95.0|-34.75|9.15|||||||
1678244|NCT01263496|3088079|Superiority or Other||Mean Difference (Final Values)|-7.44|||||2-Sided|95.0|-30.25|15.37|||||||
1678245|NCT01263496|3088079|Superiority or Other||Mean Difference (Final Values)|9.86|||||2-Sided|95.0|-13.56|33.28|||||||
1678246|NCT01263496|3088079|Superiority or Other||Mean Difference (Final Values)|18.45|||||2-Sided|95.0|-5.18|42.09|||||||
1678247|NCT01263496|3088080|Superiority or Other||Mean Difference (Final Values)|-30.58|||||2-Sided|95.0|-47.75|-13.41|||||||
1678248|NCT01263496|3088080|Superiority or Other||Mean Difference (Final Values)|-17.8|||||2-Sided|95.0|-35.46|-0.13|||||||
1678249|NCT01263496|3088080|Superiority or Other||Mean Difference (Final Values)|-5.45|||||2-Sided|95.0|-23.93|13.02|||||||
1678250|NCT01263496|3088080|Superiority or Other||Mean Difference (Final Values)|-7.02|||||2-Sided|95.0|-28.15|14.1|||||||
1678251|NCT01263496|3088081|Superiority or Other||Mean Difference (Final Values)|-13.28|||||2-Sided|95.0|-23.83|-2.74|||||||
1678252|NCT01263496|3088081|Superiority or Other||Mean Difference (Final Values)|-5.44|||||2-Sided|95.0|-15.62|4.75|||||||
1678253|NCT01263496|3088081|Superiority or Other||Mean Difference (Final Values)|-2.04|||||2-Sided|95.0|-11.74|7.66|||||||
1678254|NCT01263496|3088081|Superiority or Other||Mean Difference (Final Values)|-0.8|||||2-Sided|95.0|-11.44|9.84|||||||
1678255|NCT01263496|3088082|Superiority or Other||Mean Difference (Final Values)|-9.2|||||2-Sided|95.0|-20.58|2.17|||||||
1678256|NCT01263496|3088082|Superiority or Other||Mean Difference (Final Values)|-2.69|||||2-Sided|95.0|-13.36|7.98|||||||
1678257|NCT01263496|3088082|Superiority or Other||Mean Difference (Final Values)|1.63|||||2-Sided|95.0|-8.63|11.89|||||||
1678258|NCT01263496|3088082|Superiority or Other||Mean Difference (Final Values)|4.7|||||2-Sided|95.0|-7.09|16.49|||||||
1678259|NCT01263496|3088083|Superiority or Other||Mean Difference (Final Values)|-0.66|||||2-Sided|95.0|-11.32|9.99|||||||
1678260|NCT01263496|3088083|Superiority or Other||Mean Difference (Final Values)|-1.08|||||2-Sided|95.0|-12.91|10.75|||||||
1678261|NCT01263496|3088083|Superiority or Other||Mean Difference (Final Values)|-1.08|||||2-Sided|95.0|-11.41|9.24|||||||
1678262|NCT01263496|3088083|Superiority or Other||Mean Difference (Final Values)|7.66|||||2-Sided|95.0|-3.88|19.19|||||||
1678263|NCT01263496|3088084|Superiority or Other||Mean Difference (Final Values)|-8.96|||||2-Sided|95.0|-18.35|0.44|||||||
1678264|NCT01263496|3088084|Superiority or Other||Mean Difference (Final Values)|-8.41|||||2-Sided|95.0|-18.77|1.96|||||||
1678265|NCT01263496|3088084|Superiority or Other||Mean Difference (Final Values)|-3.02|||||2-Sided|95.0|-12.45|6.4|||||||
1678266|NCT01263496|3088084|Superiority or Other||Mean Difference (Final Values)|-1.92|||||2-Sided|95.0|-11.82|7.99|||||||
1678267|NCT01263496|3088085|Superiority or Other||Mean Difference (Final Values)|0.298|||||2-Sided|95.0|0.042|0.553|||||||
1678268|NCT01263496|3088085|Superiority or Other||Mean Difference (Final Values)|0.136|||||2-Sided|95.0|-0.126|0.398|||||||
1678269|NCT01263496|3088085|Superiority or Other||Mean Difference (Final Values)|0.26|||||2-Sided|95.0|-0.001|0.52|||||||
1678270|NCT01263496|3088085|Superiority or Other||Mean Difference (Final Values)|0.159|||||2-Sided|95.0|-0.14|0.458|||||||
1678271|NCT01263496|3088086|Superiority or Other||Mean Difference (Final Values)|-0.4|||||2-Sided|95.0|-2.874|2.074|||||||
1678272|NCT01263496|3088086|Superiority or Other||Mean Difference (Final Values)|-0.6|||||2-Sided|95.0|-3.273|2.073|||||||
1678273|NCT01263496|3088086|Superiority or Other||Mean Difference (Final Values)|0.033|||||2-Sided|95.0|-2.712|2.779|||||||
1678274|NCT01263496|3088086|Superiority or Other||Mean Difference (Final Values)|-0.95|||||2-Sided|95.0|-4.462|2.562|||||||
1678275|NCT01263496|3088087|Superiority or Other||Mean Difference (Final Values)|0.25|||||2-Sided|95.0|-0.673|1.173|||||||
1678276|NCT01263496|3088087|Superiority or Other||Mean Difference (Final Values)|0.144|||||2-Sided|95.0|-0.599|0.888|||||||
1678277|NCT01263496|3088087|Superiority or Other||Mean Difference (Final Values)|0.643|||||2-Sided|95.0|-0.305|1.591|||||||
1678278|NCT01263496|3088087|Superiority or Other||Mean Difference (Final Values)|-0.3|||||2-Sided|95.0|-1.246|0.646|||||||
1678279|NCT01263496|3088088|Superiority or Other||Mean Difference (Final Values)|0.252|||||2-Sided|95.0|-0.28|0.785|||||||
1678280|NCT01263496|3088088|Superiority or Other||Mean Difference (Final Values)|0.647|||||2-Sided|95.0|0.054|1.241|||||||
1678281|NCT01263496|3088088|Superiority or Other||Mean Difference (Final Values)|0.579|||||2-Sided|95.0|-0.035|1.194|||||||
1678282|NCT01263496|3088088|Superiority or Other||Mean Difference (Final Values)|0.281|||||2-Sided|95.0|-0.367|0.928|||||||
1678283|NCT01263496|3088089|Superiority or Other||Mean Difference (Final Values)|0.308|||||2-Sided|95.0|-0.075|0.69|||||||
1678284|NCT01263496|3088089|Superiority or Other||Mean Difference (Final Values)|0.14|||||2-Sided|95.0|-0.297|0.577|||||||
1678285|NCT01263496|3088089|Superiority or Other||Mean Difference (Final Values)|0.349|||||2-Sided|95.0|-0.156|0.855|||||||
1678286|NCT01263496|3088089|Superiority or Other||Mean Difference (Final Values)|-0.268|||||2-Sided|95.0|-0.769|0.233|||||||
1678287|NCT01263496|3088090|Superiority or Other||Mean Difference (Final Values)|0.333|||||2-Sided|95.0|0.01|0.656|||||||
1678288|NCT01263496|3088090|Superiority or Other||Mean Difference (Final Values)|0.111|||||2-Sided|95.0|-0.196|0.417|||||||
1678289|NCT01263496|3088090|Superiority or Other||Mean Difference (Final Values)|0.249|||||2-Sided|95.0|-0.043|0.542|||||||
1678290|NCT01263496|3088090|Superiority or Other||Mean Difference (Final Values)|0.035|||||2-Sided|95.0|-0.257|0.326|||||||
1678291|NCT01263496|3088091|Superiority or Other||Mean Difference (Final Values)|0.384|||||2-Sided|95.0|0.085|0.683|||||||
1678292|NCT01263496|3088091|Superiority or Other||Mean Difference (Final Values)|0.46|||||2-Sided|95.0|0.178|0.742|||||||
1678293|NCT01263496|3088091|Superiority or Other||Mean Difference (Final Values)|0.42|||||2-Sided|95.0|0.138|0.703|||||||
1678294|NCT01263496|3088091|Superiority or Other||Mean Difference (Final Values)|0.049|||||2-Sided|95.0|-0.252|0.349|||||||
1678295|NCT01263496|3088092|Superiority or Other||Mean Difference (Final Values)|0.329|||||2-Sided|95.0|0.032|0.626|||||||
1678296|NCT01263496|3088092|Superiority or Other||Mean Difference (Final Values)|0.294|||||2-Sided|95.0|0.035|0.552|||||||
1678297|NCT01263496|3088092|Superiority or Other||Mean Difference (Final Values)|0.245|||||2-Sided|95.0|-0.026|0.516|||||||
1678298|NCT01263496|3088092|Superiority or Other||Mean Difference (Final Values)|0.14|||||2-Sided|95.0|-0.13|0.41|||||||
1678299|NCT01263496|3088093|Superiority or Other||Mean Difference (Final Values)|0.331|||||2-Sided|95.0|0.098|0.565|||||||
1678300|NCT01263496|3088093|Superiority or Other||Mean Difference (Final Values)|0.308|||||2-Sided|95.0|0.076|0.54|||||||
1678301|NCT01263496|3088093|Superiority or Other||Mean Difference (Final Values)|0.358|||||2-Sided|95.0|0.104|0.612|||||||
1678302|NCT01263496|3088093|Superiority or Other||Mean Difference (Final Values)|0.226|||||2-Sided|95.0|-0.029|0.481|||||||
1678303|NCT01263496|3088094|Superiority or Other||Mean Difference (Final Values)|0.718|||||2-Sided|95.0|0.413|1.022|||||||
1678304|NCT01263496|3088094|Superiority or Other||Mean Difference (Final Values)|0.437|||||2-Sided|95.0|0.19|0.685|||||||
1678305|NCT01263496|3088094|Superiority or Other||Mean Difference (Final Values)|0.511|||||2-Sided|95.0|0.236|0.786|||||||
1678306|NCT01263496|3088094|Superiority or Other||Mean Difference (Final Values)|0.317|||||2-Sided|95.0|0.064|0.57|||||||
1678307|NCT01263496|3088095|Superiority or Other||Mean Difference (Final Values)|0.468|||||2-Sided|95.0|0.184|0.752|||||||
1678308|NCT01263496|3088095|Superiority or Other||Mean Difference (Final Values)|0.339|||||2-Sided|95.0|0.095|0.584|||||||
1678309|NCT01263496|3088095|Superiority or Other||Mean Difference (Final Values)|0.228|||||2-Sided|95.0|-0.01|0.467|||||||
1678310|NCT01263496|3088095|Superiority or Other||Mean Difference (Final Values)|0.09|||||2-Sided|95.0|-0.173|0.353|||||||
1678311|NCT01263496|3088096|Superiority or Other||Mean Difference (Final Values)|0.282|||||2-Sided|95.0|0.041|0.524|||||||
1678312|NCT01263496|3088096|Superiority or Other||Mean Difference (Final Values)|0.23|||||2-Sided|95.0|0.008|0.453|||||||
1678313|NCT01263496|3088096|Superiority or Other||Mean Difference (Final Values)|0.226|||||2-Sided|95.0|0.002|0.451|||||||
1678314|NCT01263496|3088096|Superiority or Other||Mean Difference (Final Values)|0.017|||||2-Sided|95.0|-0.219|0.254|||||||
1678315|NCT01263496|3088097|Superiority or Other||Mean Difference (Final Values)|-18.82|||||2-Sided|95.0|-27.39|-10.24|||||||
1678316|NCT01263496|3088097|Superiority or Other||Mean Difference (Final Values)|-8.28|||||2-Sided|95.0|-16.64|0.07|||||||
1678317|NCT01263496|3088097|Superiority or Other||Mean Difference (Final Values)|-6.7|||||2-Sided|95.0|-15.66|2.25|||||||
1678318|NCT01263496|3088097|Superiority or Other||Mean Difference (Final Values)|-1.65|||||2-Sided|95.0|-10.09|6.8|||||||
1678319|NCT01263496|3088098|Superiority or Other||Mean Difference (Final Values)|-13.51|||||2-Sided|95.0|-23.12|-3.89|||||||
1678320|NCT01263496|3088098|Superiority or Other||Mean Difference (Final Values)|-8.86|||||2-Sided|95.0|-17.47|-0.26|||||||
1678321|NCT01263496|3088098|Superiority or Other||Mean Difference (Final Values)|-7.05|||||2-Sided|95.0|-16.34|2.24|||||||
1678322|NCT01263496|3088098|Superiority or Other||Mean Difference (Final Values)|-1.2|||||2-Sided|95.0|-9.68|7.27|||||||
1678323|NCT01263496|3088099|Superiority or Other||Mean Difference (Final Values)|-11.88|||||2-Sided|95.0|-21.83|-1.93|||||||
1678324|NCT01263496|3088099|Superiority or Other||Mean Difference (Final Values)|-9.3|||||2-Sided|95.0|-17.93|-0.67|||||||
1678325|NCT01263496|3088099|Superiority or Other||Mean Difference (Final Values)|-7.29|||||2-Sided|95.0|-16.53|1.94|||||||
1678326|NCT01263496|3088099|Superiority or Other||Mean Difference (Final Values)|-2.43|||||2-Sided|95.0|-11.0|6.15|||||||
1678327|NCT01263496|3088100|Superiority or Other||Mean Difference (Final Values)|-9.74|||||2-Sided|95.0|-19.4|-0.08|||||||
1678328|NCT01263496|3088100|Superiority or Other||Mean Difference (Final Values)|-3.97|||||2-Sided|95.0|-12.94|5.0|||||||
1678329|NCT01263496|3088100|Superiority or Other||Mean Difference (Final Values)|-3.7|||||2-Sided|95.0|-13.1|5.7|||||||
1678330|NCT01263496|3088100|Superiority or Other||Mean Difference (Final Values)|-1.72|||||2-Sided|95.0|-10.2|6.75|||||||
1678331|NCT01263496|3088101|Superiority or Other||Mean Difference (Final Values)|-9.38|||||2-Sided|95.0|-18.59|-0.18|||||||
1678332|NCT01263496|3088101|Superiority or Other||Mean Difference (Final Values)|-1.88|||||2-Sided|95.0|-9.71|5.95|||||||
1678333|NCT01263496|3088101|Superiority or Other||Mean Difference (Final Values)|-0.98|||||2-Sided|95.0|-10.16|8.21|||||||
1678334|NCT01263496|3088101|Superiority or Other||Mean Difference (Final Values)|0.34|||||2-Sided|95.0|-7.1|7.77|||||||
1678335|NCT01263496|3088102|Superiority or Other||Mean Difference (Final Values)|-12.47|||||2-Sided|95.0|-22.18|-2.76|||||||
1678336|NCT01263496|3088102|Superiority or Other||Mean Difference (Final Values)|-8.47|||||2-Sided|95.0|-16.52|-0.42|||||||
1678337|NCT01263496|3088102|Superiority or Other||Mean Difference (Final Values)|-5.9|||||2-Sided|95.0|-15.64|3.84|||||||
1678338|NCT01263496|3088102|Superiority or Other||Mean Difference (Final Values)|-2.26|||||2-Sided|95.0|-10.42|5.9|||||||
1678339|NCT01263496|3088103|Superiority or Other||Mean Difference (Final Values)|-11.22|||||2-Sided|95.0|-20.72|-1.73|||||||
1678340|NCT01263496|3088103|Superiority or Other||Mean Difference (Final Values)|-5.85|||||2-Sided|95.0|-14.36|2.67|||||||
1678341|NCT01263496|3088103|Superiority or Other||Mean Difference (Final Values)|-3.77|||||2-Sided|95.0|-13.53|5.99|||||||
1678342|NCT01263496|3088103|Superiority or Other||Mean Difference (Final Values)|-5.44|||||2-Sided|95.0|-13.19|2.31|||||||
1678343|NCT01263496|3088104|Superiority or Other||Mean Difference (Final Values)|-12.73|||||2-Sided|95.0|-22.67|-2.78|||||||
1678344|NCT01263496|3088104|Superiority or Other||Mean Difference (Final Values)|-6.93|||||2-Sided|95.0|-15.28|1.41|||||||
1678345|NCT01263496|3088104|Superiority or Other||Mean Difference (Final Values)|-6.25|||||2-Sided|95.0|-15.84|3.35|||||||
1678346|NCT01263496|3088104|Superiority or Other||Mean Difference (Final Values)|-2.44|||||2-Sided|95.0|-11.97|7.08|||||||
1678347|NCT01263496|3088105|Superiority or Other||Mean Difference (Final Values)|-11.9|||||2-Sided|95.0|-20.74|-3.06|||||||
1678348|NCT01263496|3088105|Superiority or Other||Mean Difference (Final Values)|-5.43|||||2-Sided|95.0|-13.3|2.44|||||||
1678349|NCT01263496|3088105|Superiority or Other||Mean Difference (Final Values)|-3.36|||||2-Sided|95.0|-12.16|5.44|||||||
1678350|NCT01263496|3088105|Superiority or Other||Mean Difference (Final Values)|-2.27|||||2-Sided|95.0|-11.22|6.67|||||||
1678351|NCT01263496|3088106|Superiority or Other||Mean Difference (Final Values)|-15.49|||||2-Sided|95.0|-24.27|-6.72|||||||
1678352|NCT01263496|3088106|Superiority or Other||Mean Difference (Final Values)|-9.21|||||2-Sided|95.0|-17.2|-1.23|||||||
1678353|NCT01263496|3088106|Superiority or Other||Mean Difference (Final Values)|-10.73|||||2-Sided|95.0|-18.97|-2.49|||||||
1678354|NCT01263496|3088106|Superiority or Other||Mean Difference (Final Values)|-6.9|||||2-Sided|95.0|-15.66|1.86|||||||
1678355|NCT01263496|3088107|Superiority or Other||Mean Difference (Final Values)|-12.37|||||2-Sided|95.0|-21.44|-3.31|||||||
1678356|NCT01263496|3088107|Superiority or Other||Mean Difference (Final Values)|-10.56|||||2-Sided|95.0|-18.58|-2.54|||||||
1678357|NCT01263496|3088107|Superiority or Other||Mean Difference (Final Values)|-9.39|||||2-Sided|95.0|-17.48|-1.3|||||||
1678358|NCT01263496|3088107|Superiority or Other||Mean Difference (Final Values)|-4.44|||||2-Sided|95.0|-12.67|3.8|||||||
1678359|NCT01263496|3088108|Superiority or Other||Mean Difference (Final Values)|-19.38|||||2-Sided|95.0|-26.93|-11.83|||||||
1678360|NCT01263496|3088108|Superiority or Other||Mean Difference (Final Values)|-13.41|||||2-Sided|95.0|-20.68|-6.15|||||||
1678361|NCT01263496|3088108|Superiority or Other||Mean Difference (Final Values)|-11.7|||||2-Sided|95.0|-19.23|-4.18|||||||
1678362|NCT01263496|3088108|Superiority or Other||Mean Difference (Final Values)|-8.51|||||2-Sided|95.0|-17.56|0.54|||||||
1678363|NCT01263496|3088109|Superiority or Other||Mean Difference (Final Values)|-0.638|||||2-Sided|95.0|-0.874|-0.402|||||||
1678364|NCT01263496|3088109|Superiority or Other||Mean Difference (Final Values)|-0.408|||||2-Sided|95.0|-0.654|-0.161|||||||
1678365|NCT01263496|3088109|Superiority or Other||Mean Difference (Final Values)|-0.245|||||2-Sided|95.0|-0.492|0.003|||||||
1678366|NCT01263496|3088109|Superiority or Other||Mean Difference (Final Values)|-0.181|||||2-Sided|95.0|-0.416|0.055|||||||
1678367|NCT01263496|3088110|Superiority or Other||Mean Difference (Final Values)|-0.477|||||2-Sided|95.0|-0.741|-0.213|||||||
1678368|NCT01263496|3088110|Superiority or Other||Mean Difference (Final Values)|-0.373|||||2-Sided|95.0|-0.637|-0.109|||||||
1678369|NCT01263496|3088110|Superiority or Other||Mean Difference (Final Values)|-0.277|||||2-Sided|95.0|-0.539|-0.015|||||||
1678370|NCT01263496|3088110|Superiority or Other||Mean Difference (Final Values)|-0.118|||||2-Sided|95.0|-0.346|0.11|||||||
1678371|NCT01263496|3088111|Superiority or Other||Mean Difference (Final Values)|-0.432|||||2-Sided|95.0|-0.69|-0.174|||||||
1678372|NCT01263496|3088111|Superiority or Other||Mean Difference (Final Values)|-0.358|||||2-Sided|95.0|-0.614|-0.103|||||||
1678373|NCT01263496|3088111|Superiority or Other||Mean Difference (Final Values)|-0.262|||||2-Sided|95.0|-0.516|-0.008|||||||
1678374|NCT01263496|3088111|Superiority or Other||Mean Difference (Net)|-0.033|||||2-Sided|95.0|-0.262|0.196|||||||
1678375|NCT01263496|3088112|Superiority or Other||Mean Difference (Final Values)|-0.435|||||2-Sided|95.0|-0.679|-0.191|||||||
1678376|NCT01263496|3088112|Superiority or Other||Mean Difference (Final Values)|-0.36|||||2-Sided|95.0|-0.608|-0.113|||||||
1678377|NCT01263496|3088112|Superiority or Other||Mean Difference (Final Values)|-0.236|||||2-Sided|95.0|-0.477|0.005|||||||
1678378|NCT01263496|3088112|Superiority or Other||Mean Difference (Final Values)|0.065|||||2-Sided|95.0|-0.16|0.289|||||||
1678379|NCT01263496|3088113|Superiority or Other||Mean Difference (Final Values)|-0.49|||||2-Sided|95.0|-0.723|-0.256|||||||
1678380|NCT01263496|3088113|Superiority or Other||Mean Difference (Final Values)|-0.374|||||2-Sided|95.0|-0.596|-0.152|||||||
1678381|NCT01263496|3088113|Superiority or Other||Mean Difference (Final Values)|-0.193|||||2-Sided|95.0|-0.453|0.067|||||||
1678382|NCT01263496|3088113|Superiority or Other||Mean Difference (Final Values)|-0.05|||||2-Sided|95.0|-0.27|0.169|||||||
1678383|NCT01263496|3088114|Superiority or Other||Mean Difference (Final Values)|-0.488|||||2-Sided|95.0|-0.724|-0.252|||||||
1678384|NCT01263496|3088114|Superiority or Other||Mean Difference (Final Values)|-0.375|||||2-Sided|95.0|-0.605|-0.145|||||||
1678385|NCT01263496|3088114|Superiority or Other||Mean Difference (Final Values)|-0.234|||||2-Sided|95.0|-0.491|0.023|||||||
1678386|NCT01263496|3088114|Superiority or Other||Mean Difference (Final Values)|-0.049|||||2-Sided|95.0|-0.279|0.182|||||||
1678387|NCT01263496|3088115|Superiority or Other||Mean Difference (Final Values)|-0.487|||||2-Sided|95.0|-0.722|-0.252|||||||
1678388|NCT01263496|3088115|Superiority or Other||Mean Difference (Final Values)|-0.341|||||2-Sided|95.0|-0.579|-0.103|||||||
1678389|NCT01263496|3088115|Superiority or Other||Mean Difference (Final Values)|-0.294|||||2-Sided|95.0|-0.542|-0.046|||||||
1678390|NCT01263496|3088115|Superiority or Other||Mean Difference (Final Values)|-0.08|||||2-Sided|95.0|-0.321|0.162|||||||
1678391|NCT01263496|3088116|Superiority or Other||Mean Difference (Final Values)|-0.467|||||2-Sided|95.0|-0.692|-0.242|||||||
1678392|NCT01263496|3088116|Superiority or Other||Mean Difference (Final Values)|-0.357|||||2-Sided|95.0|-0.59|-0.124|||||||
1678393|NCT01263496|3088116|Superiority or Other||Mean Difference (Final Values)|-0.241|||||2-Sided|95.0|-0.471|-0.011|||||||
1678394|NCT01263496|3088116|Superiority or Other||Mean Difference (Final Values)|-0.079|||||2-Sided|95.0|-0.323|0.166|||||||
1678395|NCT01263496|3088117|Superiority or Other||Mean Difference (Final Values)|-0.533|||||2-Sided|95.0|-0.752|-0.314|||||||
1678396|NCT01263496|3088117|Superiority or Other||Mean Difference (Final Values)|-0.37|||||2-Sided|95.0|-0.601|-0.139|||||||
1678397|NCT01263496|3088117|Superiority or Other||Mean Difference (Final Values)|-0.319|||||2-Sided|95.0|-0.55|-0.088|||||||
1678398|NCT01263496|3088117|Superiority or Other||Mean Difference (Final Values)|-0.172|||||2-Sided|95.0|-0.41|0.065|||||||
1678399|NCT01263496|3088118|Superiority or Other||Mean Difference (Final Values)|-0.583|||||2-Sided|95.0|-0.78|-0.386|||||||
1678400|NCT01263496|3088118|Superiority or Other||Mean Difference (Final Values)|-0.405|||||2-Sided|95.0|-0.616|-0.195|||||||
1678401|NCT01263496|3088118|Superiority or Other||Mean Difference (Final Values)|-0.395|||||2-Sided|95.0|-0.598|-0.192|||||||
1678402|NCT01263496|3088118|Superiority or Other||Mean Difference (Final Values)|-0.263|||||2-Sided|95.0|-0.479|-0.047|||||||
1678403|NCT01263496|3088119|Superiority or Other||Mean Difference (Final Values)|-0.647|||||2-Sided|95.0|-0.834|-0.461|||||||
1678404|NCT01263496|3088119|Superiority or Other||Mean Difference (Final Values)|-0.51|||||2-Sided|95.0|-0.706|-0.314|||||||
1678405|NCT01263496|3088119|Superiority or Other||Mean Difference (Final Values)|-0.493|||||2-Sided|95.0|-0.684|-0.302|||||||
1678406|NCT01263496|3088119|Superiority or Other||Mean Difference (Final Values)|-0.316|||||2-Sided|95.0|-0.538|-0.093|||||||
1678407|NCT01263496|3088120|Superiority or Other||Mean Difference (Final Values)|-0.708|||||2-Sided|95.0|-0.894|-0.522|||||||
1678408|NCT01263496|3088120|Superiority or Other||Mean Difference (Final Values)|-0.59|||||2-Sided|95.0|-0.779|-0.401|||||||
1678409|NCT01263496|3088120|Superiority or Other||Mean Difference (Final Values)|-0.548|||||2-Sided|95.0|-0.739|-0.358|||||||
1678410|NCT01263496|3088120|Superiority or Other||Mean Difference (Final Values)|-0.401|||||2-Sided|95.0|-0.618|-0.184|||||||
1678411|NCT01263483|3088122|Superiority or Other||Mean Difference (Final Values)|-20.04|||||2-Sided|95.0|-37.82|-2.27|||||||
1678412|NCT01263483|3088122|Superiority or Other||Mean Difference (Final Values)|-18.77|||||2-Sided|95.0|-36.65|-0.9|||||||
1678413|NCT01263483|3088123|Superiority or Other||Mean Difference (Final Values)|0.428|||||2-Sided|95.0|-0.233|1.09|||||||
1678414|NCT01263483|3088123|Superiority or Other||Mean Difference (Final Values)|0.55|||||2-Sided|95.0|-0.045|1.144|||||||
1678415|NCT01263483|3088124|Superiority or Other||Mean Difference (Final Values)|3.967|||||2-Sided|95.0|-0.521|8.455|||||||
1678416|NCT01263483|3088124|Superiority or Other||Mean Difference (Final Values)|7.093|||||2-Sided|95.0|2.229|11.958|||||||
1678417|NCT01263483|3088125|Superiority or Other||Mean Difference (Final Values)|-72.49|||||2-Sided|95.0|-93.1|-51.88|||||||
1678418|NCT01263483|3088125|Superiority or Other||Mean Difference (Final Values)|-70.38|||||2-Sided|95.0|-90.67|-50.09|||||||
1678419|NCT01263483|3088126|Superiority or Other||Mean Difference (Final Values)|-33.73|||||2-Sided|95.0|-44.88|-22.57|||||||
1678420|NCT01263483|3088126|Superiority or Other||Mean Difference (Final Values)|-31.54|||||2-Sided|95.0|-41.28|-21.8|||||||
1678421|NCT01263483|3088127|Superiority or Other||Mean Difference (Final Values)|0.082|||||2-Sided|95.0|-0.124|0.288|||||||
1678422|NCT01263483|3088127|Superiority or Other||Mean Difference (Final Values)|0.035|||||2-Sided|95.0|-0.183|0.252|||||||
1678423|NCT01263483|3088128|Superiority or Other||Mean Difference (Final Values)|-0.073|||||2-Sided|95.0|-0.261|0.115|||||||
1678424|NCT01263483|3088128|Superiority or Other||Mean Difference (Final Values)|-0.038|||||2-Sided|95.0|-0.268|0.191|||||||
1678425|NCT01263483|3088129|Superiority or Other||Mean Difference (Final Values)|-0.034|||||2-Sided|95.0|-0.264|0.196|||||||
1678426|NCT01263483|3088129|Superiority or Other||Mean Difference (Final Values)|0.013|||||2-Sided|95.0|-0.267|0.292|||||||
1678427|NCT01263483|3088130|Superiority or Other||Mean Difference (Final Values)|-0.036|||||2-Sided|95.0|-0.239|0.167|||||||
1678428|NCT01263483|3088130|Superiority or Other||Mean Difference (Final Values)|-0.1|||||2-Sided|95.0|-0.304|0.104|||||||
1678429|NCT01263483|3088131|Superiority or Other||Mean Difference (Final Values)|-12.97|||||2-Sided|95.0|-21.53|-4.41|||||||
1678430|NCT01263483|3088131|Superiority or Other||Mean Difference (Final Values)|-13.53|||||2-Sided|95.0|-21.46|-5.6|||||||
1678431|NCT01263483|3088132|Superiority or Other||Mean Difference (Final Values)|-19.34|||||2-Sided|95.0|-27.34|-11.34|||||||
1678432|NCT01263483|3088132|Superiority or Other||Mean Difference (Final Values)|-18.3|||||2-Sided|95.0|-26.09|-10.5|||||||
1678433|NCT01263483|3088133|Superiority or Other||Mean Difference (Final Values)|-22.03|||||2-Sided|95.0|-29.68|-14.38|||||||
1678434|NCT01263483|3088133|Superiority or Other||Mean Difference (Final Values)|-15.65|||||2-Sided|95.0|-23.02|-8.27|||||||
1678435|NCT01263483|3088134|Superiority or Other||Mean Difference (Final Values)|-15.33|||||2-Sided|95.0|-21.93|-8.73|||||||
1678436|NCT01263483|3088134|Superiority or Other||Mean Difference (Final Values)|-12.01|||||2-Sided|95.0|-18.5|-5.52|||||||
1678437|NCT01263483|3088135|Superiority or Other||Mean Difference (Final Values)|-0.749|||||2-Sided|95.0|-0.875|-0.623|||||||
1678438|NCT01263483|3088135|Superiority or Other||Mean Difference (Final Values)|-0.738|||||2-Sided|95.0|-0.871|-0.605|||||||
1678439|NCT01263483|3088136|Superiority or Other||Mean Difference (Final Values)|-0.414|||||2-Sided|95.0|-0.504|-0.324|||||||
1678440|NCT01263483|3088136|Superiority or Other||Mean Difference (Final Values)|-0.421|||||2-Sided|95.0|-0.507|-0.334|||||||
1678441|NCT01263483|3088137|Superiority or Other||Mean Difference (Final Values)|-0.19|||||2-Sided|95.0|-0.247|-0.133|||||||
1678442|NCT01263483|3088137|Superiority or Other||Mean Difference (Final Values)|-0.176|||||2-Sided|95.0|-0.229|-0.123|||||||
1678443|NCT01263483|3088138|Superiority or Other||Mean Difference (Final Values)|-0.947|||||2-Sided|95.0|-1.097|-0.796|||||||
1678444|NCT01263483|3088138|Superiority or Other||Mean Difference (Final Values)|-1.002|||||2-Sided|95.0|-1.166|-0.838|||||||
1678445|NCT01263470|3088139|Superiority or Other||Mean Difference (Final Values)|-3.17|||||2-Sided|95.0|-18.04|11.71|||||||
1678446|NCT01263470|3088139|Superiority or Other||Mean Difference (Final Values)|3.69|||||2-Sided|95.0|-12.02|19.4|||||||
1678447|NCT01263470|3088139|Superiority or Other||Mean Difference (Final Values)|11.76|||||2-Sided|95.0|-2.67|26.19|||||||
1678448|NCT01263470|3088139|Superiority or Other||Mean Difference (Final Values)|4.75|||||2-Sided|95.0|-9.79|19.29|||||||
1678449|NCT01263470|3088139|Superiority or Other||Mean Difference (Final Values)|-3.66|||||2-Sided|95.0|-16.27|8.94|||||||
1678450|NCT01263470|3088139|Superiority or Other||Mean Difference (Final Values)|3.19|||||2-Sided|95.0|-10.56|16.95|||||||
1678451|NCT01263470|3088139|Superiority or Other||Mean Difference (Final Values)|11.26|||||2-Sided|95.0|-0.9|23.42|||||||
1678452|NCT01263470|3088139|Superiority or Other||Mean Difference (Final Values)|4.25|||||2-Sided|95.0|-7.87|16.38|||||||
1678453|NCT01263470|3088140|Superiority or Other||Mean Difference (Final Values)|1.358|||||2-Sided|95.0|0.76|1.956|||||||
1678454|NCT01263470|3088140|Superiority or Other||Mean Difference (Final Values)|1.398|||||2-Sided|95.0|0.759|2.036|||||||
1678455|NCT01263470|3088140|Superiority or Other||Mean Difference (Final Values)|1.163|||||2-Sided|95.0|0.551|1.774|||||||
1678456|NCT01263470|3088140|Superiority or Other||Mean Difference (Final Values)|0.934|||||2-Sided|95.0|0.315|1.552|||||||
1678457|NCT01263470|3088140|Superiority or Other||Mean Difference (Final Values)|0.959|||||2-Sided|95.0|0.43|1.489|||||||
1678458|NCT01263470|3088140|Superiority or Other||Mean Difference (Final Values)|0.999|||||2-Sided|95.0|0.418|1.58|||||||
1678459|NCT01263470|3088140|Superiority or Other||Mean Difference (Final Values)|0.764|||||2-Sided|95.0|0.214|1.315|||||||
1678460|NCT01263470|3088140|Superiority or Other||Mean Difference (Final Values)|0.535|||||2-Sided|95.0|-0.019|1.089|||||||
1678461|NCT01263470|3088141|Superiority or Other||Mean Difference (Final Values)|14.357|||||2-Sided|95.0|7.013|21.701|||||||
1678462|NCT01263470|3088141|Superiority or Other||Mean Difference (Final Values)|19.515|||||2-Sided|95.0|13.629|25.401|||||||
1678463|NCT01263470|3088141|Superiority or Other||Mean Difference (Final Values)|17.257|||||2-Sided|95.0|11.353|23.16|||||||
1678464|NCT01263470|3088141|Superiority or Other||Mean Difference (Final Values)|14.66|||||2-Sided|95.0|7.924|21.396|||||||
1678465|NCT01263470|3088141|Superiority or Other||Mean Difference (Final Values)|2.557|||||2-Sided|95.0|-3.763|8.877|||||||
1678466|NCT01263470|3088141|Superiority or Other||Mean Difference (Final Values)|7.715|||||2-Sided|95.0|3.181|12.248|||||||
1678467|NCT01263470|3088141|Superiority or Other||Mean Difference (Final Values)|5.456|||||2-Sided|95.0|0.748|10.165|||||||
1678468|NCT01263470|3088141|Superiority or Other||Mean Difference (Final Values)|2.859|||||2-Sided|95.0|-2.736|8.455|||||||
1678469|NCT01263470|3088142|Superiority or Other||Mean Difference (Final Values)|-31.84|||||2-Sided|95.0|-50.36|-13.33|||||||
1678470|NCT01263470|3088142|Superiority or Other||Mean Difference (Final Values)|-23.13|||||2-Sided|95.0|-41.16|-5.11|||||||
1678471|NCT01263470|3088142|Superiority or Other||Mean Difference (Final Values)|-5.07|||||2-Sided|95.0|-24.85|14.7|||||||
1678472|NCT01263470|3088142|Superiority or Other||Mean Difference (Final Values)|-2.73|||||2-Sided|95.0|-24.69|19.23|||||||
1678473|NCT01263470|3088142|Superiority or Other||Mean Difference (Final Values)|-87.43|||||2-Sided|95.0|-106.26|-68.6|||||||
1678474|NCT01263470|3088142|Superiority or Other||Mean Difference (Final Values)|-78.72|||||2-Sided|95.0|-97.03|-60.4|||||||
1678475|NCT01263470|3088142|Superiority or Other||Mean Difference (Final Values)|-60.66|||||2-Sided|95.0|-80.84|-40.47|||||||
1678476|NCT01263470|3088142|Superiority or Other||Mean Difference (Final Values)|-58.31|||||2-Sided|95.0|-80.79|-35.83|||||||
1678477|NCT01263470|3088143|Superiority or Other||Mean Difference (Final Values)|-24.27|||||2-Sided|95.0|-35.98|-12.55|||||||
1678478|NCT01263470|3088143|Superiority or Other||Mean Difference (Final Values)|-22.11|||||2-Sided|95.0|-34.22|-10.01|||||||
1678479|NCT01263470|3088143|Superiority or Other||Mean Difference (Final Values)|-4.89|||||2-Sided|95.0|-18.13|8.35|||||||
1678480|NCT01263470|3088143|Superiority or Other||Mean Difference (Final Values)|-5.36|||||2-Sided|95.0|-19.7|8.98|||||||
1678481|NCT01263470|3088143|Superiority or Other||Mean Difference (Final Values)|-42.75|||||2-Sided|95.0|-54.93|-30.58|||||||
1678482|NCT01263470|3088143|Superiority or Other||Mean Difference (Final Values)|-40.6|||||2-Sided|95.0|-53.18|-28.02|||||||
1678483|NCT01263470|3088143|Superiority or Other||Mean Difference (Final Values)|-23.38|||||2-Sided|95.0|-37.14|-9.61|||||||
1678484|NCT01263470|3088143|Superiority or Other||Mean Difference (Final Values)|-23.85|||||2-Sided|95.0|-38.75|-8.94|||||||
1678485|NCT01263470|3088144|Superiority or Other||Mean Difference (Final Values)|0.199|||||2-Sided|95.0|-0.049|0.448|||||||
1678486|NCT01263470|3088144|Superiority or Other||Mean Difference (Final Values)|0.261|||||2-Sided|95.0|0.026|0.496|||||||
1678487|NCT01263470|3088144|Superiority or Other||Mean Difference (Final Values)|0.188|||||2-Sided|95.0|-0.044|0.421|||||||
1678488|NCT01263470|3088144|Superiority or Other||Mean Difference (Final Values)|0.052|||||2-Sided|95.0|-0.236|0.34|||||||
1678489|NCT01263470|3088144|Superiority or Other||Mean Difference (Final Values)|0.186|||||2-Sided|95.0|-0.035|0.407|||||||
1678490|NCT01263470|3088144|Superiority or Other||Mean Difference (Final Values)|0.248|||||2-Sided|95.0|0.044|0.453|||||||
1678491|NCT01263470|3088144|Superiority or Other||Mean Difference (Final Values)|0.175|||||2-Sided|95.0|-0.029|0.379|||||||
1678492|NCT01263470|3088144|Superiority or Other||Mean Difference (Final Values)|0.039|||||2-Sided|95.0|-0.23|0.308|||||||
1678493|NCT01263470|3088145|Superiority or Other||Mean Difference (Final Values)|0.102|||||2-Sided|95.0|-0.118|0.322|||||||
1678494|NCT01263470|3088145|Superiority or Other||Mean Difference (Final Values)|0.299|||||2-Sided|95.0|0.071|0.526|||||||
1678495|NCT01263470|3088145|Superiority or Other||Mean Difference (Final Values)|0.12|||||2-Sided|95.0|-0.124|0.364|||||||
1678496|NCT01263470|3088145|Superiority or Other||Mean Difference (Final Values)|0.102|||||2-Sided|95.0|-0.203|0.408|||||||
1678497|NCT01263470|3088145|Superiority or Other||Mean Difference (Final Values)|-0.117|||||2-Sided|95.0|-0.355|0.121|||||||
1678498|NCT01263470|3088145|Superiority or Other||Mean Difference (Final Values)|0.079|||||2-Sided|95.0|-0.166|0.324|||||||
1678499|NCT01263470|3088145|Superiority or Other||Mean Difference (Final Values)|-0.1|||||2-Sided|95.0|-0.362|0.162|||||||
1678500|NCT01263470|3088145|Superiority or Other||Mean Difference (Final Values)|-0.117|||||2-Sided|95.0|-0.444|0.209|||||||
1678501|NCT01263470|3088146|Superiority or Other||Mean Difference (Final Values)|0.215|||||2-Sided|95.0|0.006|0.423|||||||
1678502|NCT01263470|3088146|Superiority or Other||Mean Difference (Final Values)|0.325|||||2-Sided|95.0|0.097|0.553|||||||
1678503|NCT01263470|3088146|Superiority or Other||Mean Difference (Final Values)|0.179|||||2-Sided|95.0|-0.036|0.395|||||||
1678504|NCT01263470|3088146|Superiority or Other||Mean Difference (Final Values)|0.122|||||2-Sided|95.0|-0.097|0.341|||||||
1678505|NCT01263470|3088146|Superiority or Other||Mean Difference (Final Values)|0.048|||||2-Sided|95.0|-0.14|0.235|||||||
1678506|NCT01263470|3088146|Superiority or Other||Mean Difference (Final Values)|0.158|||||2-Sided|95.0|-0.053|0.369|||||||
1678507|NCT01263470|3088146|Superiority or Other||Mean Difference (Final Values)|0.012|||||2-Sided|95.0|-0.185|0.21|||||||
1678508|NCT01263470|3088146|Superiority or Other||Mean Difference (Final Values)|-0.045|||||2-Sided|95.0|-0.245|0.156|||||||
1678509|NCT01263470|3088147|Superiority or Other||Mean Difference (Final Values)|0.151|||||2-Sided|95.0|-0.077|0.38|||||||
1678510|NCT01263470|3088147|Superiority or Other||Mean Difference (Final Values)|0.291|||||2-Sided|95.0|0.041|0.54|||||||
1678511|NCT01263470|3088147|Superiority or Other||Mean Difference (Final Values)|0.281|||||2-Sided|95.0|0.038|0.524|||||||
1678512|NCT01263470|3088147|Superiority or Other||Mean Difference (Final Values)|0.002|||||2-Sided|95.0|-0.241|0.245|||||||
1678513|NCT01263470|3088147|Superiority or Other||Mean Difference (Final Values)|0.004|||||2-Sided|95.0|-0.218|0.227|||||||
1678514|NCT01263470|3088147|Superiority or Other||Mean Difference (Final Values)|0.144|||||2-Sided|95.0|-0.103|0.39|||||||
1678515|NCT01263470|3088147|Superiority or Other||Mean Difference (Final Values)|0.134|||||2-Sided|95.0|-0.106|0.374|||||||
1678516|NCT01263470|3088147|Superiority or Other||Mean Difference (Final Values)|-0.145|||||2-Sided|95.0|-0.384|0.094|||||||
1678517|NCT01263470|3088148|Superiority or Other||Mean Difference (Final Values)|-19.52|||||2-Sided|95.0|-27.61|-11.43|||||||
1678518|NCT01263470|3088148|Superiority or Other||Mean Difference (Final Values)|-14.42|||||2-Sided|95.0|-22.04|-6.8|||||||
1678519|NCT01263470|3088148|Superiority or Other||Mean Difference (Final Values)|-11.52|||||2-Sided|95.0|-19.41|-3.64|||||||
1678520|NCT01263470|3088148|Superiority or Other||Mean Difference (Final Values)|-6.27|||||2-Sided|95.0|-15.6|3.06|||||||
1678521|NCT01263470|3088148|Superiority or Other||Mean Difference (Final Values)|-28.17|||||2-Sided|95.0|-36.05|-20.29|||||||
1678522|NCT01263470|3088148|Superiority or Other||Mean Difference (Final Values)|-23.07|||||2-Sided|95.0|-30.41|-15.73|||||||
1678523|NCT01263470|3088148|Superiority or Other||Mean Difference (Final Values)|-20.17|||||2-Sided|95.0|-27.86|-12.48|||||||
1678524|NCT01263470|3088148|Superiority or Other||Mean Difference (Final Values)|-14.92|||||2-Sided|95.0|-24.19|-5.64|||||||
1678525|NCT01263470|3088149|Superiority or Other||Mean Difference (Final Values)|-19.1|||||2-Sided|95.0|-27.8|-10.4|||||||
1678526|NCT01263470|3088149|Superiority or Other||Mean Difference (Final Values)|-15.16|||||2-Sided|95.0|-22.9|-7.42|||||||
1678527|NCT01263470|3088149|Superiority or Other||Mean Difference (Final Values)|-15.04|||||2-Sided|95.0|-22.9|-7.18|||||||
1678528|NCT01263470|3088149|Superiority or Other||Mean Difference (Final Values)|-8.55|||||2-Sided|95.0|-17.28|0.18|||||||
1678529|NCT01263470|3088149|Superiority or Other||Mean Difference (Final Values)|-28.28|||||2-Sided|95.0|-37.04|-19.52|||||||
1678530|NCT01263470|3088149|Superiority or Other||Mean Difference (Final Values)|-24.34|||||2-Sided|95.0|-32.03|-16.65|||||||
1678531|NCT01263470|3088149|Superiority or Other||Mean Difference (Final Values)|-24.22|||||2-Sided|95.0|-32.07|-16.37|||||||
1678532|NCT01263470|3088149|Superiority or Other||Mean Difference (Final Values)|-17.73|||||2-Sided|95.0|-26.52|-8.94|||||||
1678533|NCT01263470|3088150|Superiority or Other||Mean Difference (Final Values)|-13.69|||||2-Sided|95.0|-21.45|-5.94|||||||
1678534|NCT01263470|3088150|Superiority or Other||Mean Difference (Final Values)|-6.3|||||2-Sided|95.0|-13.53|0.93|||||||
1678535|NCT01263470|3088150|Superiority or Other||Mean Difference (Final Values)|-7.92|||||2-Sided|95.0|-14.76|-1.08|||||||
1678536|NCT01263470|3088150|Superiority or Other||Mean Difference (Final Values)|-5.82|||||2-Sided|95.0|-12.66|1.02|||||||
1678537|NCT01263470|3088150|Superiority or Other||Mean Difference (Final Values)|-23.47|||||2-Sided|95.0|-32.06|-14.89|||||||
1678538|NCT01263470|3088150|Superiority or Other||Mean Difference (Final Values)|-16.08|||||2-Sided|95.0|-24.14|-8.02|||||||
1678539|NCT01263470|3088150|Superiority or Other||Mean Difference (Final Values)|-17.69|||||2-Sided|95.0|-25.34|-10.05|||||||
1678540|NCT01263470|3088150|Superiority or Other||Mean Difference (Final Values)|-15.6|||||2-Sided|95.0|-23.27|-7.93|||||||
1681979|NCT01221597|3093902|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1678541|NCT01263470|3088151|Superiority or Other||Mean Difference (Final Values)|-13.69|||||2-Sided|95.0|-21.45|-5.94|||||||
1678542|NCT01263470|3088151|Superiority or Other||Mean Difference (Final Values)|-6.3|||||2-Sided|95.0|-13.53|0.93|||||||
1678543|NCT01263470|3088151|Superiority or Other||Mean Difference (Final Values)|-7.92|||||2-Sided|95.0|-14.76|-1.08|||||||
1678544|NCT01263470|3088151|Superiority or Other||Mean Difference (Final Values)|-5.82|||||2-Sided|95.0|-12.66|1.02|||||||
1678545|NCT01263470|3088151|Superiority or Other||Mean Difference (Final Values)|-23.47|||||2-Sided|95.0|-32.06|-14.89|||||||
1678546|NCT01263470|3088151|Superiority or Other||Mean Difference (Final Values)|-16.08|||||2-Sided|95.0|-24.14|-8.02|||||||
1678547|NCT01263470|3088151|Superiority or Other||Mean Difference (Final Values)|-17.69|||||2-Sided|95.0|-25.34|-10.05|||||||
1678548|NCT01263470|3088151|Superiority or Other||Mean Difference (Final Values)|-15.6|||||2-Sided|95.0|-23.27|-7.93|||||||
1678549|NCT01263470|3088152|Superiority or Other||Mean Difference (Final Values)|-0.52|||||2-Sided|95.0|-0.683|-0.357|||||||
1678550|NCT01263470|3088152|Superiority or Other||Mean Difference (Final Values)|-0.485|||||2-Sided|95.0|-0.654|-0.315|||||||
1678551|NCT01263470|3088152|Superiority or Other||Mean Difference (Final Values)|-0.438|||||2-Sided|95.0|-0.61|-0.267|||||||
1678552|NCT01263470|3088152|Superiority or Other||Mean Difference (Final Values)|-0.325|||||2-Sided|95.0|-0.494|-0.156|||||||
1678553|NCT01263470|3088152|Superiority or Other||Mean Difference (Final Values)|-0.695|||||2-Sided|95.0|-0.832|-0.559|||||||
1678554|NCT01263470|3088152|Superiority or Other||Mean Difference (Final Values)|-0.66|||||2-Sided|95.0|-0.804|-0.516|||||||
1678555|NCT01263470|3088152|Superiority or Other||Mean Difference (Final Values)|-0.614|||||2-Sided|95.0|-0.763|-0.464|||||||
1678556|NCT01263470|3088152|Superiority or Other||Mean Difference (Final Values)|-0.5|||||2-Sided|95.0|-0.644|-0.356|||||||
1678557|NCT01263470|3088153|Superiority or Other||Mean Difference (Final Values)|-0.239|||||2-Sided|95.0|-0.346|-0.131|||||||
1678558|NCT01263470|3088153|Superiority or Other||Mean Difference (Final Values)|-0.192|||||2-Sided|95.0|-0.299|-0.085|||||||
1678559|NCT01263470|3088153|Superiority or Other||Mean Difference (Final Values)|-0.221|||||2-Sided|95.0|-0.329|-0.112|||||||
1678560|NCT01263470|3088153|Superiority or Other||Mean Difference (Final Values)|-0.178|||||2-Sided|95.0|-0.28|-0.076|||||||
1678561|NCT01263470|3088153|Superiority or Other||Mean Difference (Final Values)|-0.387|||||2-Sided|95.0|-0.485|-0.288|||||||
1678562|NCT01263470|3088153|Superiority or Other||Mean Difference (Final Values)|-0.34|||||2-Sided|95.0|-0.438|-0.241|||||||
1678563|NCT01263470|3088153|Superiority or Other||Mean Difference (Final Values)|-0.369|||||2-Sided|95.0|-0.47|-0.268|||||||
1678564|NCT01263470|3088153|Superiority or Other||Mean Difference (Final Values)|-0.326|||||2-Sided|95.0|-0.419|-0.233|||||||
1678565|NCT01263470|3088154|Superiority or Other||Mean Difference (Final Values)|-0.054|||||2-Sided|95.0|-0.114|0.006|||||||
1678566|NCT01263470|3088154|Superiority or Other||Mean Difference (Final Values)|-0.061|||||2-Sided|95.0|-0.121|0.0|||||||
1678567|NCT01263470|3088154|Superiority or Other||Mean Difference (Final Values)|-0.075|||||2-Sided|95.0|-0.136|-0.014|||||||
1678568|NCT01263470|3088154|Superiority or Other||Mean Difference (Final Values)|-0.059|||||2-Sided|95.0|-0.116|-0.003|||||||
1678569|NCT01263470|3088154|Superiority or Other||Mean Difference (Final Values)|-0.153|||||2-Sided|95.0|-0.212|-0.095|||||||
1678570|NCT01263470|3088154|Superiority or Other||Mean Difference (Final Values)|-0.16|||||2-Sided|95.0|-0.219|-0.1|||||||
1678571|NCT01263470|3088154|Superiority or Other||Mean Difference (Final Values)|-0.174|||||2-Sided|95.0|-0.234|-0.114|||||||
1678572|NCT01263470|3088154|Superiority or Other||Mean Difference (Final Values)|-0.158|||||2-Sided|95.0|-0.213|-0.104|||||||
1678573|NCT01263470|3088155|Superiority or Other||Mean Difference (Final Values)|-0.667|||||2-Sided|95.0|-0.859|-0.475|||||||
1678574|NCT01263470|3088155|Superiority or Other||Mean Difference (Final Values)|-0.607|||||2-Sided|95.0|-0.808|-0.406|||||||
1678575|NCT01263470|3088155|Superiority or Other||Mean Difference (Final Values)|-0.542|||||2-Sided|95.0|-0.743|-0.342|||||||
1678576|NCT01263470|3088155|Superiority or Other||Mean Difference (Final Values)|-0.351|||||2-Sided|95.0|-0.57|-0.132|||||||
1678577|NCT01263470|3088155|Superiority or Other||Mean Difference (Final Values)|-0.887|||||2-Sided|95.0|-1.035|-0.739|||||||
1678578|NCT01263470|3088155|Superiority or Other||Mean Difference (Final Values)|-0.826|||||2-Sided|95.0|-0.987|-0.665|||||||
1678579|NCT01263470|3088155|Superiority or Other||Mean Difference (Final Values)|-0.762|||||2-Sided|95.0|-0.925|-0.598|||||||
1678580|NCT01263470|3088155|Superiority or Other||Mean Difference (Final Values)|-0.57|||||2-Sided|95.0|-0.755|-0.386|||||||
1678581|NCT01263314|3088160|Superiority||MK-8266 0.7 mg/ 0.3 mg vs. placebo|-10.6||||0.0034|2-Sided|90.0|-16.5|-4.77|||ANOVA||||
1678582|NCT01263314|3088160|Superiority||MK-8266 0.6 mg vs. placebo|-11.7||||0.0018|2-Sided|90.0|-17.5|-5.79|||ANOVA||||
1678583|NCT01263314|3088160|Superiority||MK-8266 0.3 mg vs. placebo|-4.16||||0.1157|2-Sided|90.0|-10.0|1.7|||ANOVA||||
1678584|NCT01263314|3088160|Superiority||MK-8266 0.7 mg/ 0.3 mg vs. placebo|-4.06||||0.1895|2-Sided|90.0|-11.9|3.82|||ANOVA||||
1678585|NCT01263314|3088160|Superiority||MK-8266 0.6 mg vs. placebo|-2.59||||0.2856|2-Sided|90.0|-10.5|5.29|||ANOVA||||
1678586|NCT01263314|3088160|Superiority||MK-8266 0.3 mg vs. placebo|9.58||||0.0253|2-Sided|90.0|1.69|17.46|||ANOVA||||
1678587|NCT01263314|3088163|Other||GMR (Elderly female/Elderly male)|1.2|||||2-Sided|90.0|0.98|1.48|||||||
1678588|NCT01263314|3088163|Other||GMR (Elderly female/Elderly male)|1.26|||||2-Sided|90.0|1.02|1.55|||||||
1678589|NCT01263314|3088163|Other||GMR (Elderly female/Elderly male)|1.08|||||2-Sided|90.0|0.88|1.33|||||||
1678590|NCT01263314|3088164|Other||GMR (Elderly female/Elderly male)|1.23|||||2-Sided|90.0|0.85|1.76|||||GMR = geometric mean ratio||
1678591|NCT01263314|3088166|Other||Mean Difference (Final Values)|5.4||||0.0012|2-Sided|90.0|2.83|7.96|||ANOVA||||
1678592|NCT01263314|3088166|Other||Mean Difference (Final Values)|4.25||||0.0056|2-Sided|90.0|1.69|6.82|||ANOVA||||
1678593|NCT01263314|3088166|Other||Mean Difference (Final Values)|1.15||||0.2223|2-Sided|90.0|-1.42|3.71|||ANOVA||||
1678594|NCT01263314|3088166|Other||Mean Difference (Final Values)|7.79||||0.0019|2-Sided|90.0|3.85|11.72|||ANOVA||||
1678595|NCT01263314|3088166|Other||Mean Difference (Final Values)|4.12||||0.0434|2-Sided|90.0|0.18|8.05|||ANOVA||||
1678596|NCT01263314|3088166|Other||Mean Difference (Final Values)|0.47||||0.418|2-Sided|90.0|-3.47|4.41|||ANOVA||||
1678597|NCT01263314|3088167|Other||Mean Difference (Final Values)|-8.2||||0.0762|2-Sided|90.0|-17.7|1.32|||ANOVA||||
1678598|NCT01263314|3088167|Other||Mean Difference (Final Values)|-10.1||||0.0416|2-Sided|90.0|-19.6|-0.56|||ANOVA||||
1678599|NCT01263314|3088167|Other||Mean Difference (Final Values)|-6.25||||0.1346|2-Sided|90.0|-15.8|3.27|||ANOVA||||
1678600|NCT01263314|3088167|Other||Mean Difference (Final Values)|-1.67||||0.3105|2-Sided|90.0|-7.42|4.09|||ANOVA||||
1678601|NCT01263314|3088167|Other||Mean Difference (Final Values)|-1.32||||0.3474|2-Sided|90.0|-7.08|4.48|||ANOVA||||
1678602|NCT01263314|3088167|Other||Mean Difference (Final Values)|-1.25||||0.3551|2-Sided|90.0|-7.01|4.5|||ANOVA||||
1678603|NCT01263223|3088176|Superiority or Other||Mean Difference (Final Values)|-6.0||||0.0828|2-Sided|95.0|-12.8|0.8||P-value is for the Maximum Change in ABPM Diastolic BP.|Mixed Models Analysis||||
1678604|NCT01263223|3088176|Superiority or Other||Mean Difference (Final Values)|-1.5||||0.3779|2-Sided|95.0|-4.8|1.8||P-value is for the Mean Change in ABPM Diastolic BP.|Mixed Models Analysis||||
1678605|NCT01263223|3088176|Superiority or Other||Mean Difference (Final Values)|4.8||||0.2731|2-Sided|95.0|-3.9|13.6||P-value is for the Maximum Change in ABPM Systolic BP.|Mixed Models Analysis||||
1678606|NCT01263223|3088176|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.9609|2-Sided|95.0|-4.9|4.7||P-value is for the Mean Change in ABPM Systolic BP.|Mixed Models Analysis||||
1678607|NCT01263223|3088177|Superiority or Other||Mean Difference (Final Values)|27.6|||<|0.0001|2-Sided|95.0|21.1|34.2||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis||||
1678608|NCT01263223|3088177|Superiority or Other||Mean Difference (Final Values)|13.6|||<|0.0001|2-Sided|95.0|11.3|15.9||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis||||
1678609|NCT01263223|3088178|Superiority or Other||Mean Difference (Final Values)|-4.7||||0.4638|2-Sided|95.0|-17.2|7.9||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis||||
1678610|NCT01263223|3088178|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.7133|2-Sided|95.0|-5.3|3.7||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis||||
1678611|NCT01263223|3088179|Superiority or Other||Mean Difference (Final Values)|0.5||||0.8719|2-Sided|95.0|-5.7|6.8||P-value is for the Maximum Change in ABPM Diastolic BP.|Mixed Models Analysis||||
1678612|NCT01263223|3088179|Superiority or Other||Mean Difference (Final Values)|3.6||||0.0211|2-Sided|95.0|0.5|6.7||P-value is for the Mean Change in ABPM Diastolic BP.|Mixed Models Analysis||||
1678613|NCT01263223|3088179|Superiority or Other||Mean Difference (Final Values)|7.6||||0.064|2-Sided|95.0|-0.4|15.5||P-value is for the Maximum Change in ABPM Systolic BP.|Mixed Models Analysis||||
1678614|NCT01263223|3088179|Superiority or Other||Mean Difference (Final Values)|2.8||||0.212|2-Sided|95.0|-1.6|7.2||P-value is for the Mean Change in ABPM Systolic BP.|Mixed Models Analysis||||
1678615|NCT01263223|3088180|Superiority or Other||Mean Difference (Final Values)|23.0||||0.0001|2-Sided|95.0|11.4|34.5||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis||||
1678616|NCT01263223|3088180|Superiority or Other||Mean Difference (Final Values)|12.8|||<|0.0001|2-Sided|95.0|8.7|16.9||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis||||
1678617|NCT01263223|3088181|Superiority or Other||Mean Difference (Final Values)|6.53||||0.0005|2-Sided|95.0|2.95|10.1||P-value is for the Maximum Change in ABPM diastolic BP.|Mixed Models Analysis||||
1678618|NCT01263223|3088181|Superiority or Other||Mean Difference (Final Values)|5.1|||<|0.0001|2-Sided|95.0|3.37|6.82||P-value if for the Mean Change in ABPM diastolic BP.|Mixed Models Analysis||||
1678619|NCT01263223|3088181|Superiority or Other||Mean Difference (Final Values)|2.7|||<|0.2453|2-Sided|95.0|-1.88|7.29||P-value is for the Maximum Change in ABPM systolic BP.|Mixed Models Analysis||||
1678620|NCT01263223|3088181|Superiority or Other||Mean Difference (Final Values)|2.9|||<|0.0224|2-Sided|95.0|0.418|5.38||P-value is for the Mean Change in ABPM systolic BP.|Mixed Models Analysis||||
1678621|NCT01263223|3088182|Superiority or Other||Mean Difference (Final Values)|5.66||||0.002|2-Sided|95.0|2.13|9.2||P-value is for the Maximum Change in ABPM diastolic BP.|Mixed Models Analysis||||
1678622|NCT01263223|3088182|Superiority or Other||Mean Difference (Final Values)|5.51|||<|0.0001|2-Sided|95.0|3.81|7.21||P-value is for the Mean Change in ABPM diastolic BP.|Mixed Models Analysis||||
1678623|NCT01263223|3088182|Superiority or Other||Mean Difference (Final Values)|7.1|||<|0.0025|2-Sided|95.0|2.6|11.6||P-value is for the Maximum Change in ABPM systolic BP.|Mixed Models Analysis||||
1678624|NCT01263223|3088182|Superiority or Other||Mean Difference (Final Values)|6.3|||<|0.0001|2-Sided|95.0|3.9|8.8||P-value is for the Mean Change in ABPM systolic BP.|Mixed Models Analysis||||
1678625|NCT01263223|3088183|Superiority or Other||Mean Difference (Final Values)|24.4|||<|0.0001|2-Sided|95.0|17.9|30.9||P-value is for the Maximum Change in ABPM heart rate.|Mixed Models Analysis||||
1678626|NCT01263223|3088183|Superiority or Other||Mean Difference (Final Values)|9.7|||<|0.0001|2-Sided|95.0|7.4|12.0||P-value is for the Mean Change in ABPM heart rate.|Mixed Models Analysis||||
1678627|NCT01263197|3088184|Superiority or Other||LS mean difference|5.53|||||2-Sided|95.0|1.89|9.16||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678628|NCT01263197|3088184|Superiority or Other||LS mean difference|5.58|||||2-Sided|95.0|1.13|10.0||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678629|NCT01263197|3088184|Superiority or Other||LS mean difference|7.25|||||2-Sided|95.0|2.59|11.9||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678630|NCT01263197|3088184|Superiority or Other||LS mean difference|-1.17|||||2-Sided|95.0|-4.79|2.45||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678631|NCT01263197|3088184|Superiority or Other||LS mean difference|-1.95|||||2-Sided|95.0|-6.36|2.47||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678632|NCT01263197|3088184|Superiority or Other||LS mean difference|0.737|||||2-Sided|95.0|-3.9|5.38||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678633|NCT01263197|3088184|Superiority or Other||LS mean difference|3.03|||||2-Sided|95.0|0.522|5.55||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678634|NCT01263197|3088184|Superiority or Other||LS mean difference|1.07|||||2-Sided|95.0|-3.62|5.76||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678635|NCT01263197|3088184|Superiority or Other||LS mean difference|1.9|||||2-Sided|95.0|-2.17|5.98||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678636|NCT01263197|3088184|Superiority or Other||LS mean difference|-0.372|||||2-Sided|95.0|-2.88|2.14||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678637|NCT01263197|3088184|Superiority or Other||LS mean difference|-3.48|||||2-Sided|95.0|-8.17|1.21||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678638|NCT01263197|3088184|Superiority or Other||LS mean difference|0.847|||||2-Sided|95.0|-3.23|4.92||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678639|NCT01263197|3088184|Superiority or Other||LS mean difference|6.6|||||2-Sided|95.0|3.11|10.1||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678640|NCT01263197|3088184|Superiority or Other||LS mean difference|7.82|||||2-Sided|95.0|3.39|12.3||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678641|NCT01263197|3088184|Superiority or Other||LS mean difference|5.6|||||2-Sided|95.0|1.63|9.56||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678642|NCT01263197|3088184|Superiority or Other||LS mean difference|-1.82|||||2-Sided|95.0|-5.3|1.66||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678643|NCT01263197|3088184|Superiority or Other||LS mean difference|-0.975|||||2-Sided|95.0|-5.39|3.44||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678644|NCT01263197|3088184|Superiority or Other||LS mean difference|-2.88|||||2-Sided|95.0|-6.84|1.07||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678645|NCT01263197|3088184|Superiority or Other||LS mean difference|2.94|||||2-Sided|95.0|0.366|5.52||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678646|NCT01263197|3088184|Superiority or Other||LS mean difference|2.92|||||2-Sided|95.0|-0.966|6.8||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678647|NCT01263197|3088184|Superiority or Other||LS mean difference|0.878|||||2-Sided|95.0|-2.86|4.62||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678648|NCT01263197|3088184|Superiority or Other||LS mean difference|0.378|||||2-Sided|95.0|-2.2|2.95||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678649|NCT01263197|3088184|Superiority or Other||LS mean difference|-0.444|||||2-Sided|95.0|-4.33|3.44||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678650|NCT01263197|3088184|Superiority or Other||LS mean difference|-0.913|||||2-Sided|95.0|-4.65|2.82||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678651|NCT01263197|3088184|Superiority or Other||LS mean difference|6.03|||||2-Sided|95.0|3.12|8.94||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1679017|NCT01259726|3088709|Superiority or Other||||||=|0||||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared||||
1678652|NCT01263197|3088184|Superiority or Other||LS mean difference|9.12|||||2-Sided|95.0|4.3|13.9||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678653|NCT01263197|3088184|Superiority or Other||LS mean difference|2.47|||||2-Sided|95.0|-1.15|6.1||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678654|NCT01263197|3088184|Superiority or Other||LS mean difference|-1.92|||||2-Sided|95.0|-4.81|0.969||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678655|NCT01263197|3088184|Superiority or Other||LS mean difference|0.335|||||2-Sided|95.0|-4.45|5.12||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678656|NCT01263197|3088184|Superiority or Other||LS mean difference|-4.22|||||2-Sided|95.0|-7.83|-0.619||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678657|NCT01263197|3088184|Superiority or Other||LS mean difference|2.4|||||2-Sided|95.0|-0.0178|4.81||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678658|NCT01263197|3088184|Superiority or Other||LS mean difference|3.68|||||2-Sided|95.0|0.674|6.69||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678659|NCT01263197|3088184|Superiority or Other||LS mean difference|1.37|||||2-Sided|95.0|-1.34|4.07||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678660|NCT01263197|3088184|Superiority or Other||LS mean difference|-0.199|||||2-Sided|95.0|-2.58|2.18||||||Difference of LS means (test minus reference) for the average changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678661|NCT01263197|3088184|Superiority or Other||LS mean difference|1.05|||||2-Sided|95.0|-1.91|4.02||||||Difference of LS means (test minus reference) for the minimum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678662|NCT01263197|3088184|Superiority or Other||LS mean difference|-1.23|||||2-Sided|95.0|-3.9|1.44||||||Difference of LS means (test minus reference) for the maximum changes in diastolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678663|NCT01263197|3088185|Superiority or Other||LS mean difference|4.28|||||2-Sided|95.0|-0.103|8.67||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678664|NCT01263197|3088185|Superiority or Other||LS mean difference|3.71|||||2-Sided|95.0|-1.17|8.59||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678665|NCT01263197|3088185|Superiority or Other||LS mean difference|1.95|||||2-Sided|95.0|-3.27|7.17||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678666|NCT01263197|3088185|Superiority or Other||LS mean difference|-0.829|||||2-Sided|95.0|-5.2|3.54||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678667|NCT01263197|3088185|Superiority or Other||LS mean difference|-0.163|||||2-Sided|95.0|-5.0|4.68||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678668|NCT01263197|3088185|Superiority or Other||LS mean difference|-1.6|||||2-Sided|95.0|-6.79|3.59||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678669|NCT01263197|3088185|Superiority or Other||LS mean difference|2.12|||||2-Sided|95.0|-1.56|5.81||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678670|NCT01263197|3088185|Superiority or Other||LS mean difference|3.18|||||2-Sided|95.0|-1.93|8.29||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678671|NCT01263197|3088185|Superiority or Other||LS mean difference|0.327|||||2-Sided|95.0|-5.45|6.1||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678672|NCT01263197|3088185|Superiority or Other||LS mean difference|1.83|||||2-Sided|95.0|-1.85|5.52||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678673|NCT01263197|3088185|Superiority or Other||LS mean difference|1.89|||||2-Sided|95.0|-3.22|7.0||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1679018|NCT01259726|3088709|Superiority or Other||||||=|0||||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared||||
1678674|NCT01263197|3088185|Superiority or Other||LS mean difference|2.34|||||2-Sided|95.0|-3.44|8.12||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678675|NCT01263197|3088185|Superiority or Other||LS mean difference|4.84|||||2-Sided|95.0|0.319|9.37||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678676|NCT01263197|3088185|Superiority or Other||LS mean difference|3.95|||||2-Sided|95.0|-1.54|9.43||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678677|NCT01263197|3088185|Superiority or Other||LS mean difference|3.2|||||2-Sided|95.0|-2.34|8.74||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678678|NCT01263197|3088185|Superiority or Other||LS mean difference|-4.2|||||2-Sided|95.0|-8.71|0.32||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678679|NCT01263197|3088185|Superiority or Other||LS mean difference|-4.76|||||2-Sided|95.0|-10.2|0.718||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678680|NCT01263197|3088185|Superiority or Other||LS mean difference|-4.16|||||2-Sided|95.0|-9.69|1.37||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678681|NCT01263197|3088185|Superiority or Other||LS mean difference|-0.119|||||2-Sided|95.0|-4.14|3.9||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678682|NCT01263197|3088185|Superiority or Other||LS mean difference|4.36|||||2-Sided|95.0|-0.404|9.12||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678683|NCT01263197|3088185|Superiority or Other||LS mean difference|-2.11|||||2-Sided|95.0|-7.42|3.2||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678684|NCT01263197|3088185|Superiority or Other||LS mean difference|-0.333|||||2-Sided|95.0|-4.35|3.68||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678685|NCT01263197|3088185|Superiority or Other||LS mean difference|-1.17|||||2-Sided|95.0|-5.93|3.59||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678686|NCT01263197|3088185|Superiority or Other||LS mean difference|0.0309|||||2-Sided|95.0|-5.28|5.34||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678687|NCT01263197|3088185|Superiority or Other||LS mean difference|7.15|||||2-Sided|95.0|3.49|10.8||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678688|NCT01263197|3088185|Superiority or Other||LS mean difference|11.4|||||2-Sided|95.0|5.99|16.8||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678689|NCT01263197|3088185|Superiority or Other||LS mean difference|1.46|||||2-Sided|95.0|-3.61|6.53||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678690|NCT01263197|3088185|Superiority or Other||LS mean difference|-3.09|||||2-Sided|95.0|-6.73|0.557||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678691|NCT01263197|3088185|Superiority or Other||LS mean difference|0.171|||||2-Sided|95.0|-5.21|5.56||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678692|NCT01263197|3088185|Superiority or Other||LS mean difference|-6.46|||||2-Sided|95.0|-11.5|-1.41||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678693|NCT01263197|3088185|Superiority or Other||LS mean difference|2.6|||||2-Sided|95.0|-0.322|5.52||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678694|NCT01263197|3088185|Superiority or Other||LS mean difference|5.26|||||2-Sided|95.0|1.09|9.43||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678695|NCT01263197|3088185|Superiority or Other||LS mean difference|0.541|||||2-Sided|95.0|-2.94|4.02||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1679019|NCT01259726|3088709|Superiority or Other||||||=|0||||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared||||
1678696|NCT01263197|3088185|Superiority or Other||LS mean difference|2.67|||||2-Sided|95.0|-0.209|5.56||||||Difference of LS means (test minus reference) for the average changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678697|NCT01263197|3088185|Superiority or Other||LS mean difference|2.73|||||2-Sided|95.0|-1.38|6.85||||||Difference of LS means (test minus reference) for the minimum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678698|NCT01263197|3088185|Superiority or Other||LS mean difference|1.62|||||2-Sided|95.0|-1.81|5.06||||||Difference of LS means (test minus reference) for the maximum changes in systolic blood pressure on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678699|NCT01263197|3088186|Superiority or Other||LS mean difference|9.9|||||2-Sided|95.0|5.98|13.8||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678700|NCT01263197|3088186|Superiority or Other||LS mean difference|5.95|||||2-Sided|95.0|0.917|11.0||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678701|NCT01263197|3088186|Superiority or Other||LS mean difference|12.3|||||2-Sided|95.0|7.17|17.4||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678702|NCT01263197|3088186|Superiority or Other||LS mean difference|-8.76|||||2-Sided|95.0|-12.6|-4.87||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678703|NCT01263197|3088186|Superiority or Other||LS mean difference|-4.25|||||2-Sided|95.0|-9.26|0.764||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678704|NCT01263197|3088186|Superiority or Other||LS mean difference|-10.6|||||2-Sided|95.0|-15.6|-5.52||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678705|NCT01263197|3088186|Superiority or Other||LS mean difference|14.7|||||2-Sided|95.0|10.4|18.9||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678706|NCT01263197|3088186|Superiority or Other||LS mean difference|9.04|||||2-Sided|95.0|4.78|13.3||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678707|NCT01263197|3088186|Superiority or Other||LS mean difference|19.4|||||2-Sided|95.0|13.2|25.6||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678708|NCT01263197|3088186|Superiority or Other||LS mean difference|1.12|||||2-Sided|95.0|-3.23|5.47||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678709|NCT01263197|3088186|Superiority or Other||LS mean difference|2.2|||||2-Sided|95.0|-2.15|6.56||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678710|NCT01263197|3088186|Superiority or Other||LS mean difference|-1.06|||||2-Sided|95.0|-7.41|5.3||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 5, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678711|NCT01263197|3088186|Superiority or Other||LS mean difference|10.3|||||2-Sided|95.0|6.88|13.8||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678712|NCT01263197|3088186|Superiority or Other||LS mean difference|6.7|||||2-Sided|95.0|2.91|10.5||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678713|NCT01263197|3088186|Superiority or Other||LS mean difference|12.1|||||2-Sided|95.0|7.39|16.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678714|NCT01263197|3088186|Superiority or Other||LS mean difference|-8.16|||||2-Sided|95.0|-11.6|-4.71||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678715|NCT01263197|3088186|Superiority or Other||LS mean difference|-3.46|||||2-Sided|95.0|-7.22|0.297||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678716|NCT01263197|3088186|Superiority or Other||LS mean difference|-9.98|||||2-Sided|95.0|-14.6|-5.34||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678717|NCT01263197|3088186|Superiority or Other||LS mean difference|14.2|||||2-Sided|95.0|9.75|18.7||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678718|NCT01263197|3088186|Superiority or Other||LS mean difference|6.51|||||2-Sided|95.0|2.32|10.7||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1679487|NCT01256164|3089254|Superiority or Other|||||||0.003|||||||Fisher Exact|||intent-to-treat analysis|
1678719|NCT01263197|3088186|Superiority or Other||LS mean difference|17.5|||||2-Sided|95.0|11.2|23.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678720|NCT01263197|3088186|Superiority or Other||LS mean difference|1.66|||||2-Sided|95.0|-2.85|6.16||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 3, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678721|NCT01263197|3088186|Superiority or Other||LS mean difference|-2.71|||||2-Sided|95.0|-6.96|1.54||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678722|NCT01263197|3088186|Superiority or Other||LS mean difference|0.905|||||2-Sided|95.0|-5.49|7.3||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 3 where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678723|NCT01263197|3088186|Superiority or Other||LS mean difference|5.06|||||2-Sided|95.0|1.93|8.18||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678724|NCT01263197|3088186|Superiority or Other||LS mean difference|4.38|||||2-Sided|95.0|1.3|7.46||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678725|NCT01263197|3088186|Superiority or Other||LS mean difference|7.8|||||2-Sided|95.0|2.72|12.9||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the propranolol treatment arm.|
1678726|NCT01263197|3088186|Superiority or Other||LS mean difference|-8.43|||||2-Sided|95.0|-11.5|-5.33||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678727|NCT01263197|3088186|Superiority or Other||LS mean difference|-4.62|||||2-Sided|95.0|-7.67|-1.56||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678728|NCT01263197|3088186|Superiority or Other||LS mean difference|-13.9|||||2-Sided|95.0|-18.9|-8.8||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+propranolol treatment arm and reference is the LY2216684 (Group 2) treatment arm.|
1678729|NCT01263197|3088186|Superiority or Other||LS mean difference|11.7|||||2-Sided|95.0|7.87|15.5||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678730|NCT01263197|3088186|Superiority or Other||LS mean difference|6.19|||||2-Sided|95.0|2.8|9.58||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678731|NCT01263197|3088186|Superiority or Other||LS mean difference|20.0|||||2-Sided|95.0|13.7|26.2||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the albuterol treatment arm.|
1678732|NCT01263197|3088186|Superiority or Other||LS mean difference|1.55|||||2-Sided|95.0|-2.25|5.35||||||Difference of LS means (test minus reference) for the average changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678733|NCT01263197|3088186|Superiority or Other||LS mean difference|0.198|||||2-Sided|95.0|-3.19|3.59||||||Difference of LS means (test minus reference) for the minimum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678734|NCT01263197|3088186|Superiority or Other||LS mean difference|2.27|||||2-Sided|95.0|-3.96|8.49||||||Difference of LS means (test minus reference) for the maximum changes in heart rate on Day 1, where test is the LY2216684+albuterol treatment arm and reference is the LY2216684 (Group 1) treatment arm.|
1678735|NCT01263119|3088192|Superiority or Other||Ratio of Geometric LS Means|1.04|||||2-Sided|90.0|1.01|1.08||||||Least Squares (LS) geometric mean was based on pharmacodynamic INRmax of warfarin.|
1678736|NCT01263119|3088193|Superiority or Other||Ratio of Geometric LS Means|1.04|||||2-Sided|90.0|1.02|1.05||||||Least Squares (LS) geometric mean was based on pharmacodynamic AUCINR of warfarin.|
1678737|NCT01263119|3088194|Superiority or Other||Median Difference (Final Values)|0.0||||0.6094|2-Sided|90.0|-0.5|0.02|||Wilcoxon (Mann-Whitney)||||
1678738|NCT01263119|3088195|Superiority or Other||Ratio of Geometric LS Means|1.13|||||2-Sided|90.0|1.09|1.17|||||||
1678739|NCT01263119|3088196|Superiority or Other||Ratio of Geometric LS Means|1.15|||||2-Sided|90.0|1.1|1.2|||||||
1678740|NCT01263119|3088197|Superiority or Other||Median Difference (Final Values)|0.0||||0.9551|2-Sided|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)||||
1678741|NCT01263119|3088198|Superiority or Other||Ratio of Geometric LS Means|1.12|||||2-Sided|90.0|1.07|1.16|||||||
1678742|NCT01263119|3088199|Superiority or Other||Ratio of Geometric LS Means|1.07|||||2-Sided|90.0|1.0|1.13|||||||
1678743|NCT01263106|3088202|Superiority or Other||Median Difference (Final Values)|0.0||||0.8008|2-Sided|90.0|-3.0|1.0|||Wilcoxon (Mann-Whitney)||||
1678744|NCT01263106|3088203|Superiority or Other||Ratio of Geometric LS Means|0.96|||||2-Sided|90.0|0.92|1.01|||||||
1678745|NCT01263106|3088204|Superiority or Other||Ratio of Geometric LS Means|1.12|||||2-Sided|90.0|1.05|1.2|||||||
1678746|NCT01263093|3088205|Superiority or Other||Median of Paired Differences|0.0||||0.3303|2-Sided|90.0|0.0|0.25|||Wilcoxon (Mann-Whitney)||||
1678747|NCT01263093|3088207|Superiority or Other||Ratio of Geometric Least Squares Means|0.59|||||2-Sided|90.0|0.53|0.67|||||Statistical inference was made using the test treatment of LY2216684 + clopidogrel and the reference treatment of clopidogrel alone.||
1678748|NCT01263093|3088208|Superiority or Other||Ratio of Geometric Least Squares Means|0.77|||||2-Sided|90.0|0.72|0.83|||||Statistical inference was made using the test treatment of LY2216684 + clopidogrel and the reference treatment of clopidogrel alone.||
1678749|NCT01263015|3088227|Non-Inferiority or Equivalence|Adjusted mean is the estimated mean change from baseline (BL) in CD4 + Cell Count at Week 144 in each arm calculated from a repeated measures model including the following covariates: treatment, visit, BL plasma HIV-1 RNA, BL CD4 cell count, treatment*visit interaction, BL HIV-1 RNA*visit interaction and BL CD4 cell count*visit interaction. No assumptions were made about the correlations between a par.’s readings of CD4 i.e. the correlation matrix for within-subject errors is unstructured.||||||0.003||||||P-value is for the test of superiority.|Repeated Measure Mixed Model||||
1678750|NCT01263015|3088230|Non-Inferiority or Equivalence|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was >-10%.|Difference in percentage|8.3||||0.01|2-Sided|95.0|1.9|14.6||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||Week 144:Estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.||
1678751|NCT01263015|3088230|Non-Inferiority or Equivalence|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was > -10%.|Difference in percentage|7.1||||0.016|2-Sided|95.0|1.2|13.1||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||Week 96:The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.||
1678752|NCT01263015|3088232|Non-Inferiority or Equivalence|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG + ABC/3TC minus EFV/TDF/FTC) in percentages between the two treatment arms was > -10%.|Difference in percentage|7.3||||0.003|2-Sided|95.0|2.3|12.2||P-value is for the test of superiority.|Wilcoxon (Mann-Whitney)||The estimated value reflects the percentage on DTG + ABC/3TC minus the percentage on EFV/TDF/FTC.||
1678753|NCT01262989|3088233|Non-Inferiority or Equivalence|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency – National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|94.47||||||90.0|87.59|101.9|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.||
1678754|NCT01262989|3088234|Non-Inferiority or Equivalence|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency – National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|102.79||||||90.0|96.99|108.93|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.||
1678755|NCT01262989|3088235|Non-Inferiority or Equivalence|This is a bioequivalence study performed to support the register of tamsulosin hydrochloride, produced by Synthon BV, as a branded generic, to be marketed by GlaxoSmithKline Brasil Ltda., according to the requirements of the Brazilian Regulatory Agency – National Agency of Sanitary Surveillance (ANVISA).|Ratio T formulation/R formulation|102.95||||||90.0|97.17|109.07|||||The ratios between the geometric means of the test (T) and reference (R) formulations was calculated.||
1678756|NCT01262898|3088289|Superiority or Other||Slope|-0.078||||||95.0|-0.171|0.016||||||Type 2 Diabetes, Day 28|Intercept estimate was 113.23 and between participant standard deviation was 21.63
1678757|NCT01262898|3088289|Superiority or Other||Slope|-0.225|||||2-Sided|95.0|-0.32|-0.129||||||Type 2 Diabetes, Day 1|Intercept estimate was 113.23 and between participant standard deviation was 21.63
1678758|NCT01262898|3088289|Superiority or Other||Slope|-0.078|||||2-Sided|95.0|-0.171|0.016||||||Type 1 Diabetes, Day 28|Intercept estimate was 125.45 and between participant standard deviation was 21.63
1678759|NCT01262898|3088289|Superiority or Other||Slope|-0.225|||||2-Sided|95.0|-0.32|-0.129||||||Type 1 Diabetes, Day 1|Intercept estimate was 125.45 and between participant standard deviation was 21.63
1678760|NCT01262898|3088289|Superiority or Other||Mean Difference (Net)|19.39|Standard Deviation|14.47|||2-Sided|95.0|4.47|34.3|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 125 mg arm|
1678761|NCT01262898|3088289|Superiority or Other||Mean Difference (Net)|3.11|Standard Deviation|14.47|||2-Sided|95.0|-13.13|19.36|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 50 mg arm|
1678762|NCT01262898|3088289|Superiority or Other||Mean Difference (Net)|5.18|Standard Deviation|14.47|||2-Sided|95.0|-11.69|22.05|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of GSK962040 10 mg arm|
1678763|NCT01262898|3088289|Superiority or Other||Mean Difference (Net)|-12.92|Standard Deviation|14.47|||2-Sided|95.0|-28.73|2.9|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|Day 28 versus Day 1 of the Placebo arm|
1678764|NCT01262898|3088289|Superiority or Other||Mean Difference (Net)|6.65|Standard Deviation|14.47|||2-Sided|95.0|-11.18|24.47|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 125 mg versus Placebo Day 28|
1678765|NCT01262898|3088289|Superiority or Other||Mean Difference (Net)|4.22|Standard Deviation|14.47|||2-Sided|95.0|-14.64|23.08|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 50 mg vs Placebo Day 28|
1678766|NCT01262898|3088289|Superiority or Other||Mean Difference (Net)|14.74|Standard Deviation|14.47|||2-Sided|95.0|-5.06|34.53|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 10 mg versus Placebo Day 28|
1678767|NCT01262898|3088289|Superiority or Other||Mean Difference (Net)|-25.65|Standard Deviation|14.47|||2-Sided|95.0|-42.99|-8.32|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 125 mg versus Placebo Day 1|
1678768|NCT01262898|3088289|Superiority or Other||Mean Difference (Net)|-11.81|Standard Deviation|14.47|||2-Sided|95.0|-30.01|6.4|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 50 mg versus Placebo Day 1|
1678769|NCT01262898|3088289|Superiority or Other||Mean Difference (Net)|-3.36|Standard Deviation|14.47|||2-Sided|95.0|-21.96|15.24|||||The least square means were estimated using a mixed model fitting treatment, visit, treatment*visit and baseline gastric emptying half time as fixed effects, and participant as a random effect. Statistical analysis is reported using LS Means.|GSK962040 10 mg versus Placebo Day 1|
1678770|NCT01262872|3088374|Non-Inferiority or Equivalence|Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|-3.5|||||2-Sided|95.0|-29.3|17.2||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 3M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, three months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).|
1678771|NCT01262872|3088374|Non-Inferiority or Equivalence|Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|6.3|||||2-Sided|95.0|-18.0|25.7||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 5M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).|
1678772|NCT01262872|3088374|Non-Inferiority or Equivalence|Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE (see above)|6.6|||||2-Sided|95.0|-18.2|26.2||||||VE-10PP-HD 2+1d vs Synflorix 2+1d - 1M post-Dose 2. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 2 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).|
1678773|NCT01262872|3088375|Non-Inferiority or Equivalence|Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|0.6|||||2-Sided|95.0|-24.9|20.9||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).|
1678774|NCT01262872|3088375|Non-Inferiority or Equivalence|Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|5.3|||||2-Sided|95.0|-19.2|24.8||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).|
1678775|NCT01262872|3088375|Non-Inferiority or Equivalence|Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|4.5|||||2-Sided|95.0|-21.4|25.0||||||VE-10PP-HD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).|
1678776|NCT01262872|3088375|Non-Inferiority or Equivalence|Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|2.5|||||2-Sided|95.0|-22.6|22.5||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 8M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, eight months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).|
1678791|NCT01262677|3088402|Superiority||LS Mean Difference|2.4||||0.356|2-Sided|95.0|-2.7|7.4||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1679574|NCT01254565|3089433|Superiority||||||<|0.0001|||||||Fisher Exact||||
1678777|NCT01262872|3088375|Non-Inferiority or Equivalence|Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|6.4|||||2-Sided|95.0|-17.8|25.7||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 5M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, five months (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).|
1678778|NCT01262872|3088375|Non-Inferiority or Equivalence|Vaccine efficacy (VE) estimated as [(1-Relative Risk (i.e. investigational vaccine over control vaccine))*100] with 95% CI was calculated. Denominator considered for deriving VE at a considered time point was the number of subjects with swabs cultured at this time point. Power using 2 independent proportions, 1:1 randomization ratio, 1-sided test to detect group difference, 1-sided alpha=2.5%.|VE|-7.9|||||2-Sided|95.0|-36.3|14.6||||||VE-10PP-LD 3+0d vs Synflorix 3+0d - 1M post-Dose 3. The analysis aimed to compare occurrences in terms of percentage of subjects with positive nasopharyngeal sample out of the number of subjects with swabs cultured, between 2 groups, one month (M) post-dose 3 of pneumococcal vaccine administered (10PP vaccine or Synflorix™).|
1678779|NCT01262677|3088396|Superiority||Odds Ratio (OR)|0.96||||0.8932|2-Sided|95.0|0.54|1.71||Statistical testing was done at alpha = 0.05 level, two-sided.|Regression, Logistic|||Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.|
1678780|NCT01262677|3088396|Superiority||Odds Ratio (OR)|1.36||||0.3241|2-Sided|95.0|0.74|2.5||Statistical testing was done at alpha = 0.05 level, two-sided.|Regression, Logistic|||Logistic regression model was used to calculate the p-value, with the fixed effects for sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR), average hours per night of sleep at baseline as a coninuous covariate, and optimal sleep at Week 14 as dependent variable. No adjustments for multiplicity were taken.|
1678781|NCT01262677|3088397|Superiority||LS Mean Difference|0.3||||0.8654|2-Sided|95.0|-3.2|3.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678782|NCT01262677|3088397|Superiority||LS Mean Difference|-2.1||||0.2431|2-Sided|95.0|-5.8|1.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index II score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678783|NCT01262677|3088398|Superiority||LS Mean Difference|0.7||||0.7126|2-Sided|95.0|-3.1|4.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678784|NCT01262677|3088398|Superiority||LS Mean Difference|-1.1||||0.5903|2-Sided|95.0|-5.0|2.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep problems index I score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678785|NCT01262677|3088399|Superiority||LS Mean Difference|0.0||||0.9909|2-Sided|95.0|-4.9|4.8||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678786|NCT01262677|3088399|Superiority||LS Mean Difference|-6.4||||0.0119|2-Sided|95.0|-11.4|-1.4||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep somnolence score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678787|NCT01262677|3088400|Superiority||LS Mean Difference|-1.6||||0.6371|2-Sided|95.0|-8.5|5.2||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678788|NCT01262677|3088400|Superiority||LS Mean Difference|-0.4||||0.9053|2-Sided|95.0|-7.5|6.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep adequacy score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678789|NCT01262677|3088401|Superiority||LS Mean Difference|0.0||||0.9388|2-Sided|95.0|-0.3|0.3||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678790|NCT01262677|3088401|Superiority||LS Mean Difference|0.2||||0.1129|2-Sided|95.0|-0.1|0.5||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: quantity of sleep at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678792|NCT01262677|3088402|Superiority||LS Mean Difference|0.8||||0.7708|2-Sided|95.0|-4.4|5.9||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: awaken short of breath or with headache score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678793|NCT01262677|3088403|Superiority||LS Mean Difference|6.7||||0.0319|2-Sided|95.0|0.6|12.9||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678794|NCT01262677|3088403|Superiority||LS Mean Difference|-2.7||||0.3972|2-Sided|95.0|-9.1|3.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: snoring score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678795|NCT01262677|3088404|Superiority||LS Mean Difference|0.3||||0.8971|2-Sided|95.0|-4.0|4.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678796|NCT01262677|3088404|Superiority||LS Mean Difference|-0.8||||0.7347|2-Sided|95.0|-5.2|3.6||Statistical testing was done at alpha = 0.05 level, two-sided.|ANOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: sleep disturbance score at baseline as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678797|NCT01262677|3088405|Superiority||LS Mean Difference|-0.5||||0.1893|2-Sided|95.0|-1.4|0.3||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.|
1678798|NCT01262677|3088405|Superiority||LS Mean Difference|-0.5||||0.2693|2-Sided|95.0|-1.3|0.4||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-D baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.|
1678799|NCT01262677|3088406|Superiority||LS Mean Difference|0.0||||0.9692|2-Sided|95.0|-0.8|0.8||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.|
1678800|NCT01262677|3088406|Superiority||LS Mean Difference|-0.3||||0.465|2-Sided|95.0|-1.1|0.5||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA|||ANCOVA model with the following fixed terms was used to calculate the p-value: HADS-A baseline score as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). No adjustments for multiplicity were taken.|
1678801|NCT01262677|3088407|Superiority||LS Mean Difference|-10.78||||0.1905|2-Sided|95.0|-24.81|5.87||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678802|NCT01262677|3088407|Superiority||LS Mean Difference|2.28||||0.8034|2-Sided|95.0|-14.37|22.15||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678803|NCT01262677|3088408|Superiority|||||||0.927||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.|
1678804|NCT01262677|3088408|Superiority|||||||0.67||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) wtih percentage of responders summarized by treatment group was used to calculate the p-value.|
1678805|NCT01262677|3088409|Superiority||LS Mean Difference|0.75||||0.9024|2-Sided|95.0|-10.69|13.66||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678851|NCT01262456|3088448|Superiority or Other||Mean Difference (Final Values)|38.95||||0.0064|2-Sided|95.0|11.03|66.88||A priori threshold for significance was p<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (<65, >=65) and baseline time to first nocturnal void using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).|
1678806|NCT01262677|3088409|Superiority||LS Mean Difference|-1.38||||0.8268|2-Sided|95.0|-12.97|11.75||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg CR, pregabalin 330 mg CR).|
1678807|NCT01262677|3088410|Superiority||LS Mean Difference|-0.16||||0.4109|2-Sided|95.0|-0.53|0.22||Statistical testing was done at alpha = 0.05 level, two-sided.|GLM|||A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.|
1678808|NCT01262677|3088410|Superiority||LS Mean Difference|-0.11||||0.6073|2-Sided|95.0|-0.53|0.31||Statistical testing was done at alpha = 0.05 level, two-sided.|Generalized linear model (GLM)|||A generalized linear model accounting for treatment and geographical region as fixed effects and baseline seizure frequency as a covariate was used to calculate the p-value. This generalized linear model assumed that the SGTC seizure frequency was from a Poisson distribution with a canonical log link function.|
1678809|NCT01262677|3088411|Superiority||LS Mean Difference|-25.84||||0.0786|2-Sided|95.0|-54.64|2.97||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model was used to calculate the p-value.|
1678810|NCT01262677|3088411|Superiority||LS Mean Difference|-9.3||||0.5404|2-Sided|95.0|-39.16|20.56||Statistical testing was done at alpha = 0.05 level, two-sided.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model was used to calculate the p-value.|
1678811|NCT01262677|3088412|Superiority|||||||0.125||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.|
1678812|NCT01262677|3088412|Superiority|||||||0.752||||||Statistical testing was done at alpha = 0.05 level, two-sided.|Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test stratified by geographical region (U.S., Europe, Asia, or Rest of the World) was used to calculate the p-value. No adjustments for multiplicity were taken.|
1678813|NCT01262677|3088413|Superiority||Mean Difference|-13.05||||0.0907|2-Sided|95.0|-26.07|2.25||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.|
1678814|NCT01262677|3088413|Superiority||Mean Difference|-0.99||||0.9076|2-Sided|95.0|-16.28|17.11||Statistical testing was done at 95% confidence intervals, two-sided, least square means and their standard errors.|ANCOVA||Value is percent reduction in seizures relative to placebo.|ANCOVA model with the following fixed terms was used to calculate the p-value: loge (baseline 28-day seizure rate + 1) as a coninuous covariate, sites pooled by geographic region (ie, U.S., Europe, Asia, rest of the world), and treatment group (placebo, pregabalin 165 mg controlled-release (CR), pregabalin 330 mg CR). 88 participants in each group (264 total) should have provided approximately 90% power.|
1678815|NCT01262651|3088424|Superiority||Median Difference (Final Values)|3.41||||0.0854|2-Sided|95.0|0.0|8.16|||Wilcoxon (Mann-Whitney)||||
1678816|NCT01262599|3088427|Superiority|Applies to primary and secondary outcomes: Data were analyzed using one-way analysis of variance, one-way repeated measures analysis of variance, t test, or Mann-Whitney rank sum test, as appropriate. (SigmaStat 3.5; Systat Software, Inc., San Jose, Calif.). Intention-to-treat using last value carried forward was used for missing data.|||||<|0.01|||||||ANOVA|||Before the start of this study, a sample size analysis, assuming a clinically meaningful 50± 40 percent (mean ± SD) decrease in pain scores from pulsed electromagnetic field treatment, suggested that a minimum of 11 patients per group were needed.|
1678817|NCT01262560|3088430|Superiority or Other|||||||0.69|||||||Wilcoxon (Mann-Whitney)|Because data was not normally distributed, this test was used instead of the t-test.||Each experimental arm was compared to the control arm (i.e. 2 comparisons) using two-sample t-tests. Forty-five patients with data in each arm, provides 80% power to detect an effect size (in standard deviation units) of 0.60 and 90% power to detect an effect size of 0.69 using a two-sided T-test with a Bonferroni adjusted significance level of 0.05 for each comparison (overall alpha 0.10). Due to the lack of prior data on the PRO-CTCAE, moderate effect sizes were used.|
1678818|NCT01262560|3088430|Superiority or Other|||||||0.39|||||||Wilcoxon (Mann-Whitney)|Because data was not normally distributed, this test was used instead of the t-test.||Each experimental arm was compared to the control arm (i.e. 2 comparisons) using two-sample t-tests. Forty-five patients with data in each arm, provides 80% power to detect an effect size (in standard deviation units) of 0.60 and 90% power to detect an effect size of 0.69 using a two-sided T-test with a Bonferroni adjusted significance level of 0.05 for each comparison (overall alpha 0.10). Due to the lack of prior data on the PRO-CTCAE, moderate effect sizes were used.|
1678819|NCT01262560|3088433|Superiority or Other|||||||0.28|||||||t-test, 2 sided||||
1678820|NCT01262560|3088433|Superiority or Other|||||||0.2|||||||t-test, 2 sided||||
1678821|NCT01262560|3088434|Superiority or Other|||||||0.88||||||significance level = 0.05|t-test, 2 sided||||
1678822|NCT01262560|3088434|Superiority or Other|||||||0.53||||||significance level = 0.05|t-test, 2 sided||||
1678823|NCT01262560|3088435|Superiority or Other|||||||0.31||||||Significance level = 0.05|Fisher Exact||||
1678824|NCT01262560|3088435|Superiority or Other|||||||0.06||||||Significance level = 0.05|Fisher Exact||||
1678825|NCT01262560|3088436|Superiority|||||||0.28|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."|
1678826|NCT01262560|3088436|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each exploratory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."|
1678827|NCT01262560|3088436|Superiority||||||<|0.28|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."|
1678828|NCT01262560|3088436|Superiority or Other||||||<|0.58|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."|
1678829|NCT01262560|3088436|Superiority or Other||||||<|0.94|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC pain score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."|
1678830|NCT01262560|3088436|Superiority||||||<|0.36|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."|
1678831|NCT01262560|3088436|Superiority||||||<|0.0066|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."|
1678832|NCT01262560|3088436|Superiority||||||<|0.44|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."|
1678833|NCT01262560|3088436|Superiority or Other||||||<|0.2|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."|
1678834|NCT01262560|3088436|Superiority or Other||||||<|0.086|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with EORTC global health status (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."|
1678835|NCT01262560|3088437|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."|
1678836|NCT01262560|3088437|Superiority||||||<|0.0051|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."|
1678837|NCT01262560|3088437|Superiority||||||<|0.0002|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."|
1678852|NCT01262456|3088448|Superiority or Other||Mean Difference (Final Values)|42.76||||0.0026|2-Sided|95.0|15.02|70.51||A priori threshold for significance was p<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (<65, >=65) and baseline time to first nocturnal void using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).|
1681980|NCT01221597|3093903|Superiority or Other|||||||0.0451|||||||ANOVA||||
1678838|NCT01262560|3088437|Superiority or Other||||||<|0.71|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."|
1678839|NCT01262560|3088437|Superiority or Other||||||<|0.7|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with dysphagia score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. Treatment (Liquid Honey vs. Supportive Care) is reported here."|
1678840|NCT01262560|3088438|Superiority||||||<|0.0001||||||Each explanatory variable is reported separately.|Mixed Models Analysis|||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Time is reported here."|
1678841|NCT01262560|3088438|Superiority||||||<|0.0025|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Opioid use is reported here."|
1678842|NCT01262560|3088438|Superiority||||||<|0.0023|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Percentage of esophagus is reported here."|
1678843|NCT01262560|3088438|Superiority||||||<|0.46|||||||Mixed Models Analysis|Each explanatory variable is reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Lozenge Honey vs. Supportive Care) is reported here."|
1678844|NCT01262560|3088438|Superiority or Other||||||<|0.87|||||||Mixed Models Analysis|Explanatory variables are reported separately.||"A linear fixed effects model using maximum likelihood estimation was run with NRPS score (baseline, weekly during treatment and 12 weeks from the end of treatment) as the outcome of interest. Percentage of esophagus (V60>=30% as reference level), opioid use (yes as reference level), time, and treatment arm were factors in the model. The results for each explanatory variable are reported separately. Treatment (Liquid Honey vs. Supportive Care) is reported here."|
1678845|NCT01262560|3088439|Superiority or Other|||||||0.93||||||Due to the skewed nature of the data, median was reported instead of mean.|Wilcoxon (Mann-Whitney)|Each arm had less than the designed sample size. Therefore the statistical power was reduced (76% instead of 80%)||Null hypothesis: Manuka honey in lozenge form is/not effective at reducing esophagitis-related pain, measured by mean change score from 0 to 4 weeks. A 2-sample t-test for difference of means with alpha 0.05 after adjusting for multiple comparisons (1-sided with overall alpha 0.1 before the Bonferroni adjustment) and 80% statistical power for each hypothesis test requires 45 patients per arm to detect >= 15% relative reduction (absolute difference of mean change score of 3.1; effect size=0.53).|
1678846|NCT01262560|3088439|Superiority or Other|||||||0.92||||||Due to the skewed nature of the data, median was reported instead of mean.|Wilcoxon (Mann-Whitney)|Each arm had less than the designed sample size. Therefore the statistical power was reduced (76% instead of 80%).||Null hypothesis: Manuka honey in liquid form is/not effective at reducing esophagitis-related pain, measured by mean change score from 0 to 4 weeks. A 2-sample t-test for difference of means with alpha 0.05 after adjusting for multiple comparisons (1-sided with overall alpha 0.1 before the Bonferroni adjustment) and 80% statistical power for each hypothesis test requires 45 patients per arm to detect >= 15% relative reduction (absolute difference of mean change score of 3.1; effect size=0.53).|
1678847|NCT01262456|3088446|Superiority or Other||Mean Difference (Final Values)|-18.79||||0.7353|2-Sided|95.0|-127.99|90.41||A priori threshold for significance was p<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (<65, >=65) and baseline 24-hour urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).|
1678848|NCT01262456|3088446|Superiority or Other||Mean Difference (Final Values)|-45.31||||0.4126|2-Sided|95.0|-153.94|63.32||A priori threshold for significance was p<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (<65, >=65) and baseline 24-hour urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).|
1678849|NCT01262456|3088447|Superiority or Other||Mean Difference (Final Values)|-77.8||||0.0086|2-Sided|95.0|-135.7|-19.89||A priori threshold for significance was p<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (<65, >=65) and baseline nocturnal urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).|
1678850|NCT01262456|3088447|Superiority or Other||Mean Difference (Final Values)|-86.17||||0.0034|2-Sided|95.0|-143.69|-28.64||A priori threshold for significance was p<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (<65, >=65) and baseline nocturnal urine volume using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).|
1679020|NCT01259726|3088710|Superiority or Other||||||<|0.0001||||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared||||
1678853|NCT01262456|3088449|Superiority or Other||Odds Ratio (OR)|1.72||||0.0386|2-Sided|95.0|1.03|2.87||A priori threshold for significance was p<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (<65, >=65) and baseline nocturnal voids using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).|
1678854|NCT01262456|3088449|Superiority or Other||Odds Ratio (OR)|1.81||||0.0233|2-Sided|95.0|1.08|3.02||A priori threshold for significance was p<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (<65, >=65) and baseline nocturnal voids using last observation carried forward.||The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).|
1678855|NCT01262456|3088450|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.0128|2-Sided|95.0|-0.52|-0.06||A priori threshold for significance was p<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (<65, >=65) and baseline nocturnal voids.||"Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.~The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|
1678856|NCT01262456|3088450|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.0029|2-Sided|95.0|-0.57|-0.12||A priori threshold for significance was p<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (<65, >=65) and baseline nocturnal voids using last observation carried forward.||"Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.~The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg)."|
1678857|NCT01262456|3088451|Superiority or Other||Odds Ratio (OR)|1.98||||0.0009|2-Sided|95.0|1.32|2.96||A priori threshold for significance was p<=0.05.|Generalized Estimating Equation (GEE)|GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (<65, ≥65 years), visit, and baseline nocturnal voids.||Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.|
1678858|NCT01262456|3088451|Superiority or Other||Odds Ratio (OR)|2.04||||0.0004|2-Sided|95.0|1.38|3.03||A priori threshold for significance was p<=0.05.|Generalized Estimating Equation (GEE)|GEE Method for 33% responder status at Week 1, Month 1, Month 2, and Month 3, adjusted for age (<65, ≥65 years), visit, and baseline nocturnal voids.||Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.|
1678859|NCT01262456|3088452|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.0003|2-Sided|95.0|-0.57|-0.17||A priori threshold for significance was p<=0.05|ANCOVA|Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (<65, ≥65 years), visit, and baseline nocturnal voids.||"Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."|
1678860|NCT01262456|3088452|Superiority or Other||Mean Difference (Final Values)|-0.41|||<|0.0001|2-Sided|95.0|-0.61|-0.22||A priori threshold for significance was p<=0.05.|ANCOVA|Repeated measures ANCOVA of change from baseline at Week 1, Months 1, 2, 3, adjusted for age (<65, ≥65 years), visit, and baseline nocturnal voids.||"Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."|
1678861|NCT01262365|3088458|Superiority||Odds Ratio (OR)|1.164|||=|0|2-Sided|95.0|0.79|1.714|||Regression, Logistic|p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.||Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.|
1678862|NCT01262365|3088458|Superiority||Odds Ratio (OR)|1.307|||=|0|2-Sided|95.0|0.888|1.923|||Regression, Logistic|p-values have been calculated using logistic regression with factors for treatment, region, and baseline disease status.||Odds Ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, region, and baseline disease status.|
1678863|NCT01262352|3088459|Superiority or Other||Mean Difference (Final Values)|3.991||||0.3796|2-Sided|95.0|-5.4|13.39||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||The raw scores in CFQ-R were summarized into different domains of health (12 domains for adolescents and adults 14 years of age and older, 8 domains for children ages 12 and 13 years, 8 domains for children ages 6 to 11 years, and 11 domains for parents/caregivers). Each domain was analyzed in a similar way as for the primary efficacy variable. The primary analytical focus was the respiratory health domain which was analyzed by combining all self-response questionnaire versions.|
1678864|NCT01262352|3088460|Superiority or Other||Mean Difference (Final Values)|-45.848|||<|0.0001|2-Sided|95.0|-53.54|-38.16||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||Analysis for change from baseline in average sweat chloride was similar to the analysis of the primary efficacy variable.|
1678865|NCT01262352|3088461|Superiority or Other||Mean Difference (Final Values)|7.007||||0.0117|2-Sided|95.0|1.8|12.21||P-value was not adjusted for multiple comparisons.|Mixed Models Analysis|||Analysis for this efficacy variable was performed in a similar way as the analysis for the primary efficacy variable.|
1678866|NCT01262352|3088462|Superiority or Other||Mean Difference (Final Values)|-2.069||||0.0004|2-Sided|95.0|-2.98|-1.15|||Mixed Models Analysis|||The primary analysis for the primary efficacy variable was based on a mixed effect model. The model included the absolute change from the baseline in each period as the dependent variable, sequence, treatment, and period as fixed effects, study baseline LCI as the covariate, and subject nested within sequence as the random effect.|
1678867|NCT01262287|3088464|Superiority or Other|||||||0.9|||||||t-test, 2 sided||||
1678868|NCT01262287|3088464|Superiority or Other|||||||0.9|||||||t-test, 2 sided||||
1678869|NCT01262287|3088465|Superiority or Other|||||||0.9|||||||t-test, 2 sided||||
1679051|NCT01258855|3088845|Other|||||||0.003|||||||Log Rank||||
1678870|NCT01262092|3088479|Superiority or Other||Mean Difference (Final Values)|-8.2887||||0.035||95.0||||p values <0.05 considered statistically significant|Mixed Models Analysis|Used proc GLIMMIX to model group by time (6 study visits)||"test null hypothesis that gbp and pla did not differ in terms of opioid-positive urines during the buprenorphine detox.~For the analysis, data from 2 participants in the GBP groups were excluded due to evidence of medication diversion (N=1) and not being maintained on the 1600 mg/day dose of GBP (N=1)."|
1678871|NCT01261793|3088494|Superiority||Odds Ratio (OR)|1.07|||=|0|2-Sided|95.0|0.743|1.539||p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|Regression, Logistic||Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.||
1678872|NCT01261793|3088494|Superiority||Odds Ratio (OR)|1.024|||=|0|2-Sided|95.0|0.71|1.477||p-values for the comparison of treatment groups have been calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.|Regression, Logistic||Odds ratio: Epratuzumab/Placebo calculated using logistic regression with factors for treatment, pooled region, and baseline disease status.||
1678873|NCT01261611|3088512|Non-Inferiority or Equivalence (legacy)|An ANCOVA on the change from baseline with treatment, baseline TWSTRS Total score, BTX status at baseline and pooled centre as explanatory variables had been performed. The non-inferiority margin was 3 points.|LS mean difference|1.532|||||2-Sided|95.0|-0.819|3.883||||||A pre-specified analysis of the LS mean difference between the Dysport NG and Dysport arms was performed. A total of 315 subjects were included in the analysis.|
1678874|NCT01261611|3088512|Superiority or Other (legacy)||||||<|0.0001|||||||ANCOVA|An ANCOVA on the change from baseline, baseline TWSTRS Total score, baseline BTX status and pooled centre as explanatory variables was performed.||A pre-specified analysis of the LS mean difference between the Dysport and Placebo arms was performed. A total of 213 subjects were included in the analysis.|
1678875|NCT01261611|3088512|Superiority or Other (legacy)||||||<|0.0001|||||||ANCOVA|An ANCOVA on the change from baseline, baseline TWSTRS Total score, baseline BTX status and pooled centre as explanatory variables was performed.||A pre-specified analysis of the LS mean difference between the Dysport NG and Placebo arms was performed. A total of 210 subjects were included in the analysis.|
1678876|NCT01261559|3088515|Superiority or Other||Mean Difference (Final Values)|14.2|Standard Deviation|10.0||0.003|2-Sided|95.0|4.0|25.0|||Regression, Linear|A multivariate linear regression model was fitted for the main outcome of percent relative dose, with age, BMI, and bra cup size as covariates.||Powered to detect difference of 10% at 80% power if 66 or more subjects enrolled.|
1678877|NCT01261507|3088519|Superiority or Other||difference in areas under the LROC curve|-0.059|Standard Error of the Mean|0.037|<|0.05|2-Sided|95.0|-0.086|-0.031|||mixed model:Dorfman, Berbaum, Metz|||Measure is the difference between the radiologists working without the software less the value for the radiologists working with the software. Thus a negative value would indicate that the the radiologists showed better results when using the software.|
1678878|NCT01261390|3088559|Superiority or Other||Mean Difference (Final Values)|99.0||||0.003|2-Sided||||||Mixed Models Analysis|Adjusted for intervention and study duration (number of nights), and randomization (CVD; site; diagnostic sleep study type; PAP device type).|Estimated value is minutes of use per night.|We performed a mixed effects analysis of the effect of Motivational Enhancement (ME) on nightly CPAP adherence. Our model included every night of data and adjusted for intervention and study duration (number of nights), as well as randomization stratification factors (CVD; site; diagnostic sleepstudy type; PAP device type).|
1678879|NCT01261390|3088560|Superiority or Other||Mean Difference (Net)|-2.677|Standard Error of the Mean|1.652|||2-Sided|95.0|-5.915|0.561|||||Presented average of the treatment effects on 24hr SBP at 6months and 12months: (6mo + 12mo)/ 2; Comparison: ActivePAP Control. Adjusted for randomization factors (CVD; site; sleepstudy type) with subjectspecific slopes and intercepts.|"We conducted a linear mixed effects regression (LMER) to estimate the treatment effect of CPAP on mean 24hour Systolic Blood Pressure (SBP). Timepoint, treatment, and the timepoint* treatment interaction were included as fixed effects, as were randomization stratification factors. Subject was included as a random effect. Let: y = observed SBP; β = fixed effects; u = random effects; X = known design matrix; Z = vector of subjects~Then our model is:~y = Xβ + Zu + ε"|
1678880|NCT01261325|3088561|Superiority or Other||Hazard Ratio (HR)|0.68|||<|0.001|2-Sided|95.0|0.55|0.85||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|||
1678881|NCT01261325|3088561|Superiority or Other||Hazard Ratio (HR)|0.75|||<|0.009|2-Sided|95.0|0.6|0.93||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|||
1678882|NCT01261325|3088562|Superiority or Other||Hazard Ratio (HR)|0.58|||<|0.001|2-Sided|95.0|0.47|0.71||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.||
1678883|NCT01261325|3088562|Superiority or Other||Hazard Ratio (HR)|0.65|||<|0.001|2-Sided|95.0|0.53|0.8||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.||
1678884|NCT01261325|3088563|Superiority or Other||Hazard Ratio (HR)|0.65|||<|0.001|2-Sided|95.0|0.54|0.79||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.||
1678885|NCT01261325|3088563|Superiority or Other||Hazard Ratio (HR)|0.67|||<|0.001|2-Sided|95.0|0.56|0.82||Statistically significant at a nominal 0.050 significance level.|Semi-parametric hazards regression model|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|Hazard ratio is Brivaracetam versus Placebo.||
1678886|NCT01261325|3088567|Superiority or Other||Median difference vs placebo|18.1|||<|0.001|2-Sided|95.0|10.4|26.4||Statistically significant at a nominal 0.050 significance level.|Wilcoxon (Mann-Whitney)||Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.||
1678887|NCT01261325|3088567|Superiority or Other||Median difference vs placebo|15.8|||<|0.001|2-Sided|95.0|7.6|24.2||Statistically significant at a nominal 0.050 significance level.|Wilcoxon (Mann-Whitney)||Hodges-Lehmann non-parametric effect estimates and corresponding two-sided 95% confidence intervals are provided above.||
1678888|NCT01261325|3088568|Superiority or Other||Odds ratio (BRV versus PBO)|2.19|||<|0.001|2-Sided|95.0|1.5|3.3||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|Regression, Logistic|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|||
1678889|NCT01261325|3088568|Superiority or Other||Odds ratio (BRV versus PBO)|2.39|||<|0.001|2-Sided|95.0|1.6|3.6||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|Regression, Logistic|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|||
1678890|NCT01261325|3088569|Superiority or Other||Percent reduction over PBO|23.2|||<|0.001|2-Sided|95.0|13.8|31.6||Statistically significant with control of Type I error rate based on a Hochberg multiple comparison procedure.|ANCOVA|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|||
1678891|NCT01261325|3088569|Superiority or Other||Percent reduction over PBO|22.8|||<|0.001|2-Sided|95.0|13.3|31.2||"Type I error rate of 0.05 based on a Hochberg multiple comparison procedure would be considered statistically significant or similar, as accurate and appropriate."|ANCOVA|Effects of treatment, country, combination of LEV status and number of previous AEDs, and log-transformed baseline seizure frequency are in the model.|||
1678892|NCT01260948|3088578|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.81|||||2-Sided|90.0|91.3|98.47|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1678893|NCT01260948|3088579|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.72|||||2-Sided|90.0|94.13|103.53|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1678894|NCT01260922|3088580|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Slope|94.75|||||2-Sided|90.0|92.11|97.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1678895|NCT01260922|3088581|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.16|||||2-Sided|90.0|97.07|107.51|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1678896|NCT01260896|3088582|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.75|||||2-Sided|90.0|92.92|102.85|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1678897|NCT01260896|3088583|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|108.26|||||2-Sided|90.0|104.84|111.79|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1678898|NCT01260896|3088584|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|114.21|||||2-Sided|90.0|109.29|119.35|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1678930|NCT01260324|3088653|Superiority or Other||Incidence rate per 1000 person-years|0.09|||||2-Sided|95.0|0.08|0.1|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Never use|
1678931|NCT01260324|3088653|Superiority or Other||Incidence rate per 1000 person-years|0.06|||||2-Sided|95.0|0.03|0.11|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Non-chronic use|
1678899|NCT01260896|3088585|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.12|||||2-Sided|90.0|97.8|108.73|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1678900|NCT01260896|3088586|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.34|||||2-Sided|90.0|100.37|110.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1678901|NCT01260896|3088587|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.84|||||2-Sided|90.0|100.54|113.54|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1678902|NCT01260584|3088625|Superiority or Other||Risk Ratio (RR)|123.8|||||2-Sided|90.0|98.6|155.4|||||Estimation was based on the ratio of Geom. means between groups. Non-smoker is the denominator.|Clopidogrel active metabolite R-130964|
1678903|NCT01260584|3088625|Superiority or Other||Risk Ratio (RR)|117.9|||||2-Sided|90.0|94.4|147.3|||||Estimation was based on the ratio of Geom. means between groups. Non-smoker is the denominator.|Prasugrel active metabolite R-138727|
1678904|NCT01260584|3088626|Superiority or Other||Risk Ratio (RR)|118.4|||||2-Sided|90.0|99.8|140.4||||||active metabolite R-130964|
1678905|NCT01260584|3088626|Superiority or Other||Risk Ratio (RR)|110.7|||||2-Sided|90.0|93.7|130.8||||||Prasugrel active metabolite R-138727|
1678906|NCT01260584|3088627|Superiority or Other||Odds Ratio (OR)|11.71||||0.0006|2-Sided|95.0|2.95|46.52|||Regression, Logistic||||
1678907|NCT01260584|3088627|Superiority or Other||Odds Ratio (OR)|58.64||||0.0003|2-Sided|95.0|6.8|505.58|||Regression, Logistic||||
1678908|NCT01260584|3088627|Superiority or Other||Odds Ratio (OR)|6.7||||0.0447|2-Sided|95.0|1.05|42.92|||Regression, Logistic||||
1678909|NCT01260584|3088627|Superiority or Other||Odds Ratio (OR)|1.34||||0.5684|2-Sided|95.0|0.49|3.67|||Regression, Logistic||||
1678910|NCT01260584|3088628|Superiority or Other||Odds Ratio (OR)|17.11||||0.0013|2-Sided|95.0|3.13|93.65|||Regression, Logistic||||
1678911|NCT01260584|3088628|Superiority or Other||Odds Ratio (OR)|16.54||||0.0127|2-Sided|95.0|1.85|148.23|||Regression, Logistic||||
1678912|NCT01260584|3088628|Superiority or Other||Odds Ratio (OR)|1.99||||0.5813|2-Sided|95.0|0.17|23.65|||Regression, Logistic||||
1678913|NCT01260584|3088628|Superiority or Other||Odds Ratio (OR)|2.06||||0.1331|2-Sided|95.0|0.8|5.32|||Regression, Logistic||||
1678914|NCT01260584|3088629|Superiority or Other||Mean Difference (Final Values)|-16.9|Standard Error of the Mean|3.76|<|0.0001|2-Sided|95.0|-24.3|-9.5|||Mixed Models Analysis||||
1678915|NCT01260584|3088629|Superiority or Other||Mean Difference (Final Values)|-24.5|Standard Error of the Mean|3.02|<|0.0001|2-Sided|95.0|-30.5|-18.5|||Mixed Models Analysis||||
1678916|NCT01260584|3088629|Superiority or Other||Mean Difference (Final Values)|-5.8|Standard Error of the Mean|3.7|<|0.1184|2-Sided|95.0|-13.1|1.5|||Mixed Models Analysis||||
1678917|NCT01260584|3088629|Superiority or Other||Mean Difference (Final Values)|-22.7|Standard Error of the Mean|3.19|<|0.0001|2-Sided|95.0|-29.0|-16.4|||Mixed Models Analysis||||
1678918|NCT01260584|3088629|Superiority or Other||Mean Difference (Final Values)|-7.6|Standard Error of the Mean|3.72|<|0.0423|2-Sided|95.0|-15.0|-0.3|||Mixed Models Analysis||||
1678919|NCT01260584|3088630|Superiority or Other||Mean Difference (Final Values)|-72.6|Standard Error of the Mean|12.73|<|0.0001|2-Sided|95.0|-97.8|-47.5|||Mixed Models Analysis||||
1678920|NCT01260584|3088630|Superiority or Other||Mean Difference (Final Values)|-108.8|Standard Error of the Mean|10.85|<|0.0001|2-Sided|95.0|-130.3|-87.3|||Mixed Models Analysis||||
1678921|NCT01260584|3088630|Superiority or Other||Mean Difference (Final Values)|-21.2|Standard Error of the Mean|12.53|<|0.0924|2-Sided|95.0|-45.9|3.5|||Mixed Models Analysis||||
1678922|NCT01260584|3088630|Superiority or Other||Mean Difference (Final Values)|-93.8|Standard Error of the Mean|11.54|<|0.0001|2-Sided|95.0|-116.7|-71.0|||Mixed Models Analysis||||
1678923|NCT01260584|3088630|Superiority or Other||Mean Difference (Final Values)|-36.2|Standard Error of the Mean|12.65|<|0.0048|2-Sided|95.0|-61.1|-11.2|||Mixed Models Analysis||||
1678924|NCT01260584|3088631|Superiority or Other||Mean Difference (Final Values)|27.0|Standard Error of the Mean|4.14|<|0.0001|2-Sided|95.0|18.8|35.2|||Mixed Models Analysis||||
1678925|NCT01260584|3088631|Superiority or Other||Mean Difference (Final Values)|34.7|Standard Error of the Mean|3.17|<|0.0001|2-Sided|95.0|28.4|41.0|||Mixed Models Analysis||||
1678926|NCT01260584|3088631|Superiority or Other||Mean Difference (Final Values)|4.8|Standard Error of the Mean|4.08|<|0.244|2-Sided|95.0|-3.3|12.8|||Mixed Models Analysis||||
1678927|NCT01260584|3088631|Superiority or Other||Mean Difference (Final Values)|31.8|Standard Error of the Mean|3.35|<|0.0001|2-Sided|95.0|25.1|38.4|||Mixed Models Analysis||||
1678928|NCT01260584|3088631|Superiority or Other||Mean Difference (Final Values)|7.7|Standard Error of the Mean|4.11|<|0.0624|2-Sided|95.0|-0.4|15.8|||Mixed Models Analysis|||For the sample size calculations for the co-primary endpoints, no Type 1 error rate was adjusted and both co-primary endpoints will be tested at the 0.05 level.|
1678929|NCT01260454|3088640|Superiority or Other|||||||0.03|||||||t-test, 2 sided|||This is open-label, uncontrolled data; the comparison is made between each individual's baseline.|
1679052|NCT01258855|3088848|Other|||||||0.43|||||||Log Rank||||
1678932|NCT01260324|3088653|Superiority or Other||Incidence rate per 1000 person-years|0.05|||||2-Sided|95.0|0.03|0.08|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Chronic use|
1678933|NCT01260324|3088653|Superiority or Other||Incidence rate per 1000 person-years|0.06|||||2-Sided|95.0|0.04|0.08|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Any use (includes chronic and non-chronic use)|
1678934|NCT01260324|3088653|Superiority or Other||Incidence rate per 1000 person-years|0.05|||||2-Sided|95.0|0.03|0.07|||||Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.|Incidence rate Recent use|
1678935|NCT01260324|3088654|Superiority or Other||Odds Ratio (OR)|1.64|||||2-Sided|95.0|1.08|2.49|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Ill defined and unknown causes of morbidity and mortality|
1678936|NCT01260324|3088654|Superiority or Other||Odds Ratio (OR)|1.37|||||2-Sided|95.0|1.02|1.84|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Symptoms involving head and neck|
1678937|NCT01260324|3088654|Superiority or Other||Odds Ratio (OR)|1.32|||||2-Sided|95.0|0.98|1.77|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other disorders of bone and cartilage|
1678938|NCT01260324|3088654|Superiority or Other||Odds Ratio (OR)|1.34|||||2-Sided|95.0|1.02|1.77|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other dermatoses|
1678939|NCT01260324|3088654|Superiority or Other||Odds Ratio (OR)|1.29|||||2-Sided|95.0|0.96|1.74|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Acute sinusitis|
1678940|NCT01260324|3088654|Superiority or Other||Odds Ratio (OR)|1.22|||||2-Sided|95.0|0.64|2.31|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Occlusion and stenosis of precerebral arteries|
1678941|NCT01260324|3088654|Superiority or Other||Odds Ratio (OR)|2.02|||||2-Sided|95.0|1.44|2.82|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other disorders of eye|
1678942|NCT01260324|3088654|Superiority or Other||Odds Ratio (OR)|15.1|||||2-Sided|95.0|6.6|34.5|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Blindness and low vision|
1678943|NCT01260324|3088654|Superiority or Other||Odds Ratio (OR)|14.2|||||2-Sided|95.0|10.4|19.3|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Visual disturbances|
1678944|NCT01260324|3088654|Superiority or Other||Odds Ratio (OR)|1.31|||||2-Sided|95.0|1.02|1.68|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Cataract|
1678945|NCT01260324|3088654|Superiority or Other||Odds Ratio (OR)|2.6|||||2-Sided|95.0|1.77|3.81|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Glaucoma|
1678946|NCT01260324|3088654|Superiority or Other||Odds Ratio (OR)|6.65|||||2-Sided|95.0|4.72|9.38|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Other retinal disorders|
1678947|NCT01260324|3088654|Superiority or Other||Incidence rate per 1000 person-years|0.14|||||2-Sided|95.0|0.1|0.18|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other ill defined and unknown causes of morbidity and mortality|
1678948|NCT01260324|3088654|Superiority or Other||Incidence rate per 1000 person-years|0.12|||||2-Sided|95.0|0.1|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Symptoms involving head and neck|
1678949|NCT01260324|3088654|Superiority or Other||Incidence rate per 1000 person-years|0.08|||||2-Sided|95.0|0.06|0.1|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other disorders of bone and cartilage|
1678950|NCT01260324|3088654|Superiority or Other||Incidence rate per 1000 person-years|0.06|||||2-Sided|95.0|0.05|0.08|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other dermatoses|
1678951|NCT01260324|3088654|Superiority or Other||Incidence rate per 1000 person-years|0.07|||||2-Sided|95.0|0.05|0.08|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Acute sinusitis|
1678952|NCT01260324|3088654|Superiority or Other||Incidence rate per 1000 person-years|0.22|||||2-Sided|95.0|0.18|0.27|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Occlusion and stenosis of precerebral arteries|
1678953|NCT01260324|3088654|Superiority or Other||Incidence rate per 1000 person-years|0.19|||||2-Sided|95.0|0.16|0.23|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other disorders of eye|
1678954|NCT01260324|3088654|Superiority or Other||Incidence rate per 1000 person-years|2.0|||||2-Sided|95.0|1.6|2.46|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Blindness and low vision|
1678955|NCT01260324|3088654|Superiority or Other||Incidence rate per 1000 person-years|0.99|||||2-Sided|95.0|0.83|1.17|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Visual disturbances|
1678956|NCT01260324|3088654|Superiority or Other||Incidence rate per 1000 person-years|0.2|||||2-Sided|95.0|0.08|0.41|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Cataract|
1678957|NCT01260324|3088654|Superiority or Other||Incidence rate per 1000 person-years|0.13|||||2-Sided|95.0|0.11|0.16|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Glaucoma|
1678958|NCT01260324|3088654|Superiority or Other||Incidence rate per 1000 person-years|0.33|||||2-Sided|95.0|0.28|0.39|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Other retinal disorders|
1678959|NCT01260324|3088655|Superiority or Other||Odds Ratio (OR)|0.57|||||2-Sided|95.0|0.31|1.04|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Recent PDE-5 inhibitors use|
1678960|NCT01260324|3088655|Superiority or Other||Odds Ratio (OR)|2.24|||||2-Sided|95.0|1.46|3.43|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Diuretics|
1678961|NCT01260324|3088655|Superiority or Other||Odds Ratio (OR)|2.12|||||2-Sided|95.0|1.53|2.94|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Anti-platelet agents|
1678962|NCT01260324|3088655|Superiority or Other||Odds Ratio (OR)|0.63|||||2-Sided|95.0|0.42|0.94|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Nitrates|
1678963|NCT01260324|3088655|Superiority or Other||Odds Ratio (OR)|0.43|||||2-Sided|95.0|0.23|0.81|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Obesity|
1678964|NCT01260324|3088655|Superiority or Other||Odds Ratio (OR)|1.34|||||2-Sided|95.0|0.63|2.85|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Smoking|
1678965|NCT01260324|3088655|Superiority or Other||Odds Ratio (OR)|1.82|||||2-Sided|95.0|1.47|2.25|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Diabetes|
1678966|NCT01260324|3088655|Superiority or Other||Incidence rate per 1000 person-years|0.03|||||2-Sided|95.0|0.01|0.04|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Recent PDE-5 inhibitors use|
1678967|NCT01260324|3088655|Superiority or Other||Incidence rate per 1000 person-years|0.13|||||2-Sided|95.0|0.09|0.17|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Diuretics|
1678968|NCT01260324|3088655|Superiority or Other||Incidence rate per 1000 person-years|0.15|||||2-Sided|95.0|0.12|0.18|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Anti-platelet agents|
1678969|NCT01260324|3088655|Superiority or Other||Incidence rate per 1000 person-years|0.07|||||2-Sided|95.0|0.06|0.09|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Nitrates|
1678970|NCT01260324|3088655|Superiority or Other||Incidence rate per 1000 person-years|0.04|||||2-Sided|95.0|0.03|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Obesity|
1678971|NCT01260324|3088655|Superiority or Other||Incidence rate per 1000 person-years|0.11|||||2-Sided|95.0|0.08|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Smoking|
1678972|NCT01260324|3088655|Superiority or Other||Incidence rate per 1000 person-years|0.09|||||2-Sided|95.0|0.08|0.1|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Diabetes|
1678973|NCT01260324|3088656|Superiority or Other||Odds Ratio (OR)|0.73|||||2-Sided|95.0|0.57|0.93|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio West|
1678974|NCT01260324|3088656|Superiority or Other||Odds Ratio (OR)|0.68|||||2-Sided|95.0|0.56|0.84|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Midwest|
1678975|NCT01260324|3088656|Superiority or Other||Odds Ratio (OR)|0.41|||||2-Sided|95.0|0.31|0.56|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Northeast|
1678976|NCT01260324|3088656|Superiority or Other||Incidence rate per 1000 person-years|0.04|||||2-Sided|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate West|
1678977|NCT01260324|3088656|Superiority or Other||Incidence rate per 1000 person-years|0.05|||||2-Sided|95.0|0.05|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate South|
1678978|NCT01260324|3088656|Superiority or Other||Incidence rate per 1000 person-years|0.05|||||2-Sided|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Midwest|
1678979|NCT01260324|3088656|Superiority or Other||Incidence rate per 1000 person-years|0.05|||||2-Sided|95.0|0.04|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Northeast|
1678980|NCT01260324|3088657|Superiority or Other||Odds Ratio (OR)|0.93|||||2-Sided|95.0|0.72|1.19|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2007|
1678981|NCT01260324|3088657|Superiority or Other||Odds Ratio (OR)|0.87|||||2-Sided|95.0|0.68|1.12|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2006|
1678982|NCT01260324|3088657|Superiority or Other||Odds Ratio (OR)|0.73|||||2-Sided|95.0|0.58|0.91|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2005|
1678983|NCT01260324|3088657|Superiority or Other||Odds Ratio (OR)|0.77|||||2-Sided|95.0|0.61|0.96|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Year 2004|
1678984|NCT01260324|3088657|Superiority or Other||Incidence rate per 1000 person-years|0.05|||||2-Sided|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2007|
1679053|NCT01258855|3088849|Other|||||||0.002|||||||Log Rank||||
1678985|NCT01260324|3088657|Superiority or Other||Incidence rate per 1000 person-years|0.04|||||2-Sided|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2006|
1678986|NCT01260324|3088657|Superiority or Other||Incidence rate per 1000 person-years|0.05|||||2-Sided|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2005|
1678987|NCT01260324|3088657|Superiority or Other||Incidence rate per 1000 person-years|0.05|||||2-Sided|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2004|
1678988|NCT01260324|3088657|Superiority or Other||Incidence rate per 1000 person-years|0.05|||||2-Sided|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Year 2003|
1678989|NCT01260324|3088658|Superiority or Other||Odds Ratio (OR)|1.83|||||2-Sided|95.0|1.5|2.22|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Male|
1678990|NCT01260324|3088658|Superiority or Other||Incidence rate per 1000 person-years|0.05|||||2-Sided|95.0|0.05|0.06|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Male|
1678991|NCT01260324|3088658|Superiority or Other||Incidence rate per 1000 person-years|0.04|||||2-Sided|95.0|0.04|0.05|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Female|
1678992|NCT01260324|3088659|Superiority or Other||Odds Ratio (OR)|5.73|||||2-Sided|95.0|4.0|8.22|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age ≥75|
1678993|NCT01260324|3088659|Superiority or Other||Odds Ratio (OR)|3.83|||||2-Sided|95.0|2.68|5.47|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 65 to 74|
1678994|NCT01260324|3088659|Superiority or Other||Odds Ratio (OR)|0.37|||||2-Sided|95.0|0.3|0.45|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 45 to 54|
1678995|NCT01260324|3088659|Superiority or Other||Odds Ratio (OR)|0.11|||||2-Sided|95.0|0.08|0.16|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 35 to 44|
1678996|NCT01260324|3088659|Superiority or Other||Odds Ratio (OR)|0.09|||||2-Sided|95.0|0.06|0.13|||||Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.|Odds ratio Age 18 to 34|
1678997|NCT01260324|3088659|Superiority or Other||Incidence rate per 1000 person-years|0.18|||||2-Sided|95.0|0.15|0.21|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age ≥75|
1678998|NCT01260324|3088659|Superiority or Other||Incidence rate per 1000 person-years|0.12|||||2-Sided|95.0|0.11|0.14|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 65 to 74|
1678999|NCT01260324|3088659|Superiority or Other||Incidence rate per 1000 person-years|0.08|||||2-Sided|95.0|0.07|0.09|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 55 to 64|
1679000|NCT01260324|3088659|Superiority or Other||Incidence rate per 1000 person-years|0.03|||||2-Sided|95.0|0.03|0.04|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 45 to 54|
1679001|NCT01260324|3088659|Superiority or Other||Incidence rate per 1000 person-years|0.01|||||2-Sided|95.0|0.01|0.01|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 35 to 44|
1679002|NCT01260324|3088659|Superiority or Other||Incidence rate per 1000 person-years|0.01|||||2-Sided|95.0|0.01|0.01|||||Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.|Incidence rate Age 18 to 34|
1679003|NCT01260272|3088665|Superiority or Other|||||||0.106||||||Apriori threshold for statistical significance was <=0.05|t-test, 2 sided||||
1679004|NCT01260272|3088666|Superiority or Other||||||=|0||||||Apriori threshold for statistical significance was <=0.05|t-test, 2 sided||||
1679005|NCT01260272|3088667|Superiority or Other||||||=|0||||||Apriori threshold for statistical significance was <=0.05|t-test, 2 sided||||
1679006|NCT01260272|3088668|Superiority or Other||||||=|0||||||Apriori threshold for statistical significance was <=0.05|Wilcoxon (Mann-Whitney)||||
1679007|NCT01260272|3088669|Superiority or Other||||||=|0||||||Apriori threshold for statistical significance was <=0.05|t-test, 2 sided||||
1679008|NCT01260272|3088670|Superiority or Other||||||=|0||||||Apriori threshold for statistical significance was <=0.05|t-test, 2 sided||||
1679009|NCT01260272|3088671|Superiority or Other||||||=|0||||||Apriori threshold for statistical significance was <=0.05|t-test, 2 sided||||
1679010|NCT01260272|3088672|Superiority or Other||||||=|0||||||Apriori threshold for statistical significance was <=0.05|t-test, 2 sided||||
1679011|NCT01259726|3088707|Superiority or Other||||||=|0||||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared||||
1679012|NCT01259726|3088707|Superiority or Other||||||=|0||||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared||||
1679013|NCT01259726|3088707|Superiority or Other||||||=|0||||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared||||
1679014|NCT01259726|3088708|Superiority or Other||||||=|0||||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared||||
1679015|NCT01259726|3088708|Superiority or Other||||||=|0||||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared||||
1679016|NCT01259726|3088708|Superiority or Other||||||=|0||||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared||||
1679021|NCT01259726|3088710|Superiority or Other||||||<|0.0001||||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared||||
1679022|NCT01259726|3088710|Superiority or Other||||||<=|0||||||Treatment comparison with placebo using two-sided Chi-Square test at significance level p=0.05.|Chi-squared||||
1679023|NCT01259713|3088712|Superiority or Other||Relative risk reduction|0.08||||0.2|2-Sided|95.0|-0.04|0.19||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|Participants were not stratified for leukemia risk.|
1679024|NCT01259713|3088713|Superiority or Other|||||||0.69||||||The p-value was from the log-rank test stratified by region.|Log Rank|Participants without consolidation/salvage therapy dates were censored using the earlier of the Early Termination and Study Completion dates.|||
1679025|NCT01259713|3088714|Superiority or Other|||||||0.32||||||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||||
1679026|NCT01259713|3088715|Superiority or Other|||||||0.32||||||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||||
1679027|NCT01259713|3088716|Superiority or Other||Relative risk reduction|0.25||||0.22|2-Sided|95.0|-0.19|0.53||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.||
1679028|NCT01259713|3088717|Superiority or Other|||||||0.33||||||The p-value is from the log-rank test stratified by region.|Log Rank||||
1679029|NCT01259713|3088718|Superiority or Other||Relative risk reduction|-0.01||||0.97|2-Sided|95.0|-0.94|0.47||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.||
1679030|NCT01259713|3088719|Superiority or Other||Relative risk reduction|0.25||||0.15|2-Sided|95.0|-0.11|0.5||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.||
1679031|NCT01259713|3088720|Non-Inferiority or Equivalence|For the interim analysis performed when 50% of the subjects had completed the study, an alpha of 0.0003 was spent. Therefore, the significance level for the 2-sided test in the primary analysis at the end of the study was 0.0497 (corresponding to 95.03% confidence interval (CI)).|Relative risk reduction|0.33||||0.24|2-Sided|95.03|-0.32|0.66||P-value was from a stratum-adjusted (stratified by region) CMH test.|Cochran-Mantel-Haenszel||Relative risk reduction = 1 - risk ratio.|A two-group Cochran-Mantel-Haenszel (CMH) test with a 0.05 two-sided significance level and 2:1 allocation of 354 randomized subjects (236 AmBisome, 118 placebo) would have 81% power to detect a relative reduction of 75% if the rate of IFI is 10% in the placebo group (based on unpublished data from the German Multicenter Acute Lymphoblastic Leukemia Working Group (GMALL) and consistent with the published rate of 16.4% in patients with hematological malignancies undergoing remission induction).|
1679032|NCT01259401|3088750|Superiority or Other|||||||0.061|||||||ANCOVA||||
1679033|NCT01259401|3088751|Superiority or Other|||||||0.04|||||||ANCOVA||||
1679034|NCT01259388|3088752|Superiority or Other (legacy)|||||||0.013|||||||Wilcoxon (Mann-Whitney)||||
1679035|NCT01259388|3088754|Superiority or Other (legacy)|||||||0.346|||||||t-test, 2 sided||||
1679036|NCT01259245|3088770|Superiority or Other||Mean Difference (Final Values)|1.6|Standard Deviation|5.2||0.528|2-Sided|95.0|-3.5|6.8|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance|
1679037|NCT01259245|3088771|Superiority or Other||Mean Difference (Final Values)|0.037|Standard Deviation|0.088||0.425|2-Sided|95.0|-0.054|0.128|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance|
1679038|NCT01259245|3088772|Superiority or Other||Mean Difference (Final Values)|0.042|Standard Deviation|0.226||0.56|2-Sided|95.0|-0.1|0.184|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance|
1679039|NCT01259245|3088773|Superiority or Other||Mean Difference (Final Values)|13.049|Standard Deviation|8.89||0.004|2-Sided|95.0|4.159|21.939|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance|
1679040|NCT01259245|3088774|Superiority or Other||Mean Difference (Final Values)|-1.69|Standard Deviation|4.062||0.413|2-Sided|95.0|-5.753|2.372|||ANCOVA|adjusted for baseline value, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance|
1679041|NCT01259245|3088775|Superiority or Other||Mean Difference (Final Values)|-2.15|Standard Deviation|4.477||0.345|2-Sided|95.0|-6.627|2.327|||ANCOVA|adjusted for baseline values, age, sex, BMI, education and smoking||power of 0.80 for medium effect size at 5% level of significance|
1679042|NCT01259245|3088776|Superiority or Other||Mean Difference (Final Values)|-1.295|Standard Deviation|4.706||0.588|2-Sided|95.0|-6.001|3.411|||ANCOVA|adjusted for baseline values, age, sex, BMI, education and smoking||power of 0.80 for medium size effect at 5% level of significance|
1679043|NCT01259245|3088777|Superiority or Other||Mean Difference (Final Values)|0.372|Standard Deviation|4.433||0.869|2-Sided|95.0|-4.061|4.805|||ANCOVA|adjusted for baseline values, age, sex, education, BMI and education||power of 0.80 for a medium effect size at 5% level of significance|
1679044|NCT01259245|3088778|Superiority or Other||Mean Difference (Final Values)|0.005|Standard Deviation|0.442||0.984|2-Sided|95.0|-0.438|0.447|||ANCOVA|Adjusted for baseline values, age, sex, education, BMI and smoking||power0.80 for a medium effect size at 5% level of significance|
1679045|NCT01259245|3088779|Superiority or Other||Mean Difference (Final Values)|-0.017||||0.252|2-Sided|95.0|-0.046|0.012||Regression coefficients from ANCOVA for Tai Chi intervention (PRP as reference) at 6 months after adjusted for baseline value of the outcome variable, age, sex, BMI, smoking and education|ANCOVA||||
1679046|NCT01259011|3088821|Superiority||Slope|-4.0||||0.21|2-Sided|95.0|-10.2|2.2|||Regression, Linear||||
1679047|NCT01259011|3088822|Superiority||Slope|-2.2|||<|0.05|2-Sided|95.0|-4.2|-0.3||HADS-depression|Regression, Linear||||
1679048|NCT01259011|3088822|Superiority||Slope|-1.2|||<|0.12|2-Sided|95.0|-2.8|0.3||HADS-anxiety|Regression, Linear||||
1679049|NCT01259011|3088823|Superiority or Other||Odds Ratio (OR)|1.9|||<|0.05|2-Sided|95.0|1.1|3.3|||Mixed Models Analysis||||
1679050|NCT01258855|3088844|Other|||||||0.02|||||||Log Rank||||
1679054|NCT01258803|3088851|Superiority or Other||Mean Difference (Final Values)|0.106|||<|0.001|2-Sided|95.0|0.077|0.135|||ANCOVA|||"Pairwise Treatment Comparison of F DPI and Placebo MDI combined with or without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."|
1679055|NCT01258803|3088852|Superiority or Other||Mean Difference (Final Values)|-0.004||||0.79|2-Sided|95.0|-0.033|0.025|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI without spacer and F DPI.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."|
1679056|NCT01258803|3088853|Superiority or Other||Mean Difference (Final Values)|0.018||||0.229|2-Sided|95.0|-0.012|0.048|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and F DPI.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."|
1679057|NCT01258803|3088855|Superiority or Other||Mean Difference (Final Values)|0.022||||0.144|2-Sided|95.0|-0.008|0.052|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and MF/F MDI without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."|
1679058|NCT01258803|3088856|Superiority or Other||Mean Difference (Final Values)|0.102|||<|0.001|2-Sided|95.0|0.073|0.131|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI without spacer and Placebo MDI combined with or without spacer.~Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."|
1679059|NCT01258803|3088857|Superiority or Other||Mean Difference (Final Values)|0.124|||<|0.001|2-Sided|95.0|0.094|0.154|||ANCOVA|||"Pairwise Treatment Comparison of MF/F MDI with spacer and Placebo MDI combined with or without spacer.~Analysis was performed using an analysis of covariance (ANCOVA) model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate."|
1679060|NCT01258738|3088859|Superiority or Other||Mean Difference (Final Values)|11.03||||0.1285|2-Sided|95.0|-2.51|24.56|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.|
1679061|NCT01258738|3088860|Superiority or Other||Mean Difference (Final Values)|14.41||||14.41|2-Sided|95.0|0.04|28.78|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.|
1679062|NCT01258738|3088861|Superiority or Other||Mean Difference (Final Values)|-1.91||||0.335|2-Sided|95.0|-5.82|1.99|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12|
1679063|NCT01258738|3088861|Superiority or Other||Mean Difference (Final Values)|-1.5||||0.3554|2-Sided|95.0|-4.7|1.7|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4|
1679064|NCT01258738|3088861|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test.|
1679065|NCT01258738|3088862|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.4334|2-Sided|95.0|-1.21|0.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12|
1679066|NCT01258738|3088862|Superiority or Other||Mean Difference (Final Values)|-0.44||||0.2578|2-Sided|95.0|-1.21|0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4|
1679067|NCT01258738|3088862|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test.|
1679068|NCT01258738|3088863|Superiority or Other||Mean Difference (Final Values)|-8.68||||0.0687|2-Sided|95.0|-18.03|0.68|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679069|NCT01258738|3088863|Superiority or Other||Mean Difference (Final Values)|-5.98||||0.1476|2-Sided|95.0|-14.11|2.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679070|NCT01258738|3088863|Superiority or Other||Mean Difference (Final Values)|-5.25||||0.1648|2-Sided|95.0|-12.69|2.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679071|NCT01258738|3088863|Superiority or Other||Mean Difference (Final Values)|-8.29||||0.0382|2-Sided|95.0|-16.12|-0.46|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679072|NCT01258738|3088863|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.001 at Week 16 and at Week 32 and thereafter, from paired t test.|
1679073|NCT01258738|3088864|Superiority or Other||Mean Difference (Final Values)|-6.85||||0.0397|2-Sided|95.0|-13.38|-0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1681981|NCT01221597|3093904|Superiority or Other|||||||0.0005|||||||ANOVA||||
1679074|NCT01258738|3088864|Superiority or Other||Mean Difference (Final Values)|-6.66||||0.033|2-Sided|95.0|-12.79|-0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679075|NCT01258738|3088864|Superiority or Other||Mean Difference (Final Values)|-3.1||||0.2126|2-Sided|95.0|-7.98|1.79|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679076|NCT01258738|3088864|Superiority or Other||Mean Difference (Final Values)|-5.97||||0.0372|2-Sided|95.0|-11.58|-0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679077|NCT01258738|3088864|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.001, from paired t-test.|
1679078|NCT01258738|3088865|Superiority or Other||Mean Difference (Final Values)|-9.14||||0.0461|2-Sided|95.0|-18.11|-0.16|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679079|NCT01258738|3088865|Superiority or Other||Mean Difference (Final Values)|-6.26||||0.1224|2-Sided|95.0|-14.23|1.71|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679080|NCT01258738|3088865|Superiority or Other||Mean Difference (Final Values)|-5.08||||0.173|2-Sided|95.0|-12.41|2.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679081|NCT01258738|3088865|Superiority or Other||Mean Difference (Final Values)|-9.19||||0.0193|2-Sided|95.0|-16.85|-1.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679082|NCT01258738|3088865|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.001 at Week 16 and thereafter, from paired t-test.|
1679083|NCT01258738|3088866|Superiority or Other||Mean Difference (Final Values)|4.74||||0.2402|2-Sided|95.0|-3.22|12.69|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679084|NCT01258738|3088866|Superiority or Other||Mean Difference (Final Values)|3.52||||0.3877|2-Sided|95.0|-4.53|11.57|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679085|NCT01258738|3088866|Superiority or Other||Mean Difference (Final Values)|1.62||||0.6232|2-Sided|95.0|-4.9|8.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679086|NCT01258738|3088866|Superiority or Other||Mean Difference (Final Values)|2.37||||0.5226|2-Sided|95.0|-4.95|9.68|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679087|NCT01258738|3088866|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.05, from paired t-test.|
1679088|NCT01258738|3088867|Superiority or Other||Mean Difference (Final Values)|-0.78||||0.1829|2-Sided|95.0|-1.93|0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.|
1679089|NCT01258738|3088867|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.001, from paired t-test.|
1679090|NCT01258738|3088868|Superiority or Other||Mean Difference (Final Values)|-0.52||||0.3286|2-Sided|95.0|-1.55|0.52|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Descriptive analysis was carried out for Week 12 data only.|
1679091|NCT01258738|3088868|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.001, from paired t-test.|
1679092|NCT01258738|3088869|Superiority or Other||Mean Difference (Final Values)|-0.52||||0.2439|2-Sided|95.0|-1.39|0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12|
1679093|NCT01258738|3088869|Superiority or Other||Mean Difference (Final Values)|0.17||||0.6357|2-Sided|95.0|-0.52|0.86|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4|
1679094|NCT01258738|3088869|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.001, from paired t-test.|
1679095|NCT01258738|3088870|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.3842|2-Sided|95.0|-1.28|0.5|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12|
1679096|NCT01258738|3088870|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.4621|2-Sided|95.0|-0.9|0.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4|
1679097|NCT01258738|3088870|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.001, from paired t-test.|
1679397|NCT01257503|3089069|Superiority or Other|||||||0.79|||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in fussiness|
1679098|NCT01258738|3088871|Superiority or Other||Mean Difference (Final Values)|0.85||||0.4981|2-Sided|95.0|-1.63|3.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12|
1679099|NCT01258738|3088871|Superiority or Other||Mean Difference (Final Values)|1.18||||0.252|2-Sided|95.0|-0.84|3.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4|
1679100|NCT01258738|3088871|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.05, from paired t-test.|
1679101|NCT01258738|3088872|Superiority or Other||Mean Difference (Final Values)|2.38||||0.0134|2-Sided|95.0|0.5|4.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 12|
1679102|NCT01258738|3088872|Superiority or Other||Mean Difference (Final Values)|1.31||||0.1035|2-Sided|95.0|-0.27|2.9|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 12 data only. Week 4|
1679103|NCT01258738|3088872|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.001, from paired t-test.|
1679104|NCT01258738|3088873|Superiority or Other||Mean Difference (Final Values)|0.06||||0.1345|2-Sided|95.0|-0.02|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12|
1679105|NCT01258738|3088873|Superiority or Other||Mean Difference (Final Values)|0.07||||0.0447|2-Sided|95.0|0.0|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8|
1679106|NCT01258738|3088873|Superiority or Other||Mean Difference (Final Values)|0.05||||0.1341|2-Sided|95.0|-0.02|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4|
1679107|NCT01258738|3088873|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.01 at Week 12 and <0.001 thereafter, from paired t-test.|
1679108|NCT01258738|3088874|Superiority or Other||Mean Difference (Final Values)|6.07||||0.0394|2-Sided|95.0|0.3|11.84|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 12|
1679109|NCT01258738|3088874|Superiority or Other||Mean Difference (Final Values)|3.61||||0.197|2-Sided|95.0|-1.89|9.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 8|
1679110|NCT01258738|3088874|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.9965|2-Sided|95.0|-4.39|4.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4, 8, 12 data only. Week 4|
1679111|NCT01258738|3088874|Superiority or Other|||||||0.037|||||||t-test, 2 sided|||With the exception of change from Baseline in the placebo group at Week 12, within group comparisons to baseline for all other treatment groups and time points were <0.001, from paired t-test.|
1679112|NCT01258738|3088875|Superiority or Other||Mean Difference (Final Values)|-7.03|||<|0.0001|2-Sided|95.0|-10.34|-3.73|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679113|NCT01258738|3088875|Superiority or Other||Mean Difference (Final Values)|-5.78|||<|0.0009|2-Sided|95.0|-9.15|-2.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679114|NCT01258738|3088875|Superiority or Other||Mean Difference (Final Values)|-6.12|||<|0.0001|2-Sided|95.0|-9.16|-3.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679115|NCT01258738|3088875|Superiority or Other||Mean Difference (Final Values)|-7.71|||<|0.0001|2-Sided|95.0|-10.85|-4.58|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679116|NCT01258738|3088875|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test|
1679117|NCT01258738|3088876|Superiority or Other||Mean Difference (Final Values)|-3.12||||0.0038|2-Sided|95.0|-5.23|-1.02|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679118|NCT01258738|3088876|Superiority or Other||Mean Difference (Final Values)|-3.04||||0.0143|2-Sided|95.0|-5.47|-0.61|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679119|NCT01258738|3088876|Superiority or Other||Mean Difference (Final Values)|-3.86||||0.0008|2-Sided|95.0|-6.09|-1.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679120|NCT01258738|3088876|Superiority or Other||Mean Difference (Final Values)|-3.02|||<|0.0001|2-Sided|95.0|-4.39|-1.66|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679121|NCT01258738|3088876|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679122|NCT01258738|3088877|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.0167|2-Sided|95.0|-1.19|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679123|NCT01258738|3088877|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.4698|2-Sided|95.0|-0.7|0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679124|NCT01258738|3088877|Superiority or Other||Mean Difference (Final Values)|-0.46||||0.0769|2-Sided|95.0|-0.97|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679125|NCT01258738|3088877|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.3536|2-Sided|95.0|-0.64|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679126|NCT01258738|3088877|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test.|
1679127|NCT01258738|3088878|Superiority or Other||Mean Difference (Final Values)|0.02||||0.8291|2-Sided|95.0|-0.13|0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679128|NCT01258738|3088878|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.1208|2-Sided|95.0|-0.08|0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679129|NCT01258738|3088878|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.2547|2-Sided|95.0|-0.11|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679130|NCT01258738|3088878|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.6148|2-Sided|95.0|-0.08|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679131|NCT01258738|3088878|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test.|
1679132|NCT01258738|3088879|Superiority or Other||Mean Difference (Final Values)|0.01||||0.9891|2-Sided|95.0|-0.72|0.73|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679133|NCT01258738|3088879|Superiority or Other||Mean Difference (Final Values)|0.09||||0.8167|2-Sided|95.0|-0.69|0.87|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679134|NCT01258738|3088879|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.5402|2-Sided|95.0|-1.02|0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679135|NCT01258738|3088879|Superiority or Other||Mean Difference (Final Values)|-0.62||||0.0836|2-Sided|95.0|-1.32|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679136|NCT01258738|3088879|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.001, from paired t-test.|
1679137|NCT01258738|3088880|Superiority or Other||Mean Difference (Final Values)|-0.31||||0.0091|2-Sided|95.0|-0.54|-0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679138|NCT01258738|3088880|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.1624|2-Sided|95.0|-0.46|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679139|NCT01258738|3088880|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.1958|2-Sided|95.0|-0.42|0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679140|NCT01258738|3088880|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.2438|2-Sided|95.0|-0.52|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679141|NCT01258738|3088880|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.001, from paired t-test.|
1679142|NCT01258738|3088881|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.0132|2-Sided|95.0|-0.72|-0.08|||ANCOVA|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 12 data only."|
1679143|NCT01258738|3088882|Superiority or Other||Mean Difference (Final Values)|-0.96||||0.0414|2-Sided|95.0|-1.88|-0.04|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.|
1679144|NCT01258738|3088882|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.001, from paired t-test.|
1679145|NCT01258738|3088883|Superiority or Other||Mean Difference (Final Values)|-2.93|||<|0.001|2-Sided|95.0|-4.16|-1.7|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.|
1679146|NCT01258738|3088883|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group comparisons to baseline were <0.001, from paired t-test.|
1679147|NCT01258738|3088884|Superiority or Other||Mean Difference (Final Values)|-0.96||||0.0414|2-Sided|95.0|-1.88|-0.04|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 12 data only.|
1679148|NCT01258738|3088885|Superiority or Other||Mean Difference (Final Values)|0.13||||0.5782|2-Sided|95.0|-0.33|0.6|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 12|
1679149|NCT01258738|3088885|Superiority or Other||Mean Difference (Final Values)|0.18||||0.4453|2-Sided|95.0|-0.28|0.65|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 8|
1679150|NCT01258738|3088885|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.9777|2-Sided|95.0|-0.4|0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 4|
1679151|NCT01258738|3088885|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.6476|2-Sided|95.0|-0.46|0.29|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12, data only. Week 2|
1679152|NCT01258738|3088885|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679153|NCT01258738|3088886|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.3144|2-Sided|95.0|-0.73|0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679154|NCT01258738|3088886|Superiority or Other||Mean Difference (Final Values)|-0.41||||0.0911|2-Sided|95.0|-0.89|0.07|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679155|NCT01258738|3088886|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.6003|2-Sided|95.0|-0.61|0.35|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679156|NCT01258738|3088886|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.0129|2-Sided|95.0|-0.95|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679157|NCT01258738|3088886|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Most within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679158|NCT01258738|3088887|Superiority or Other||Mean Difference (Final Values)|0.12||||0.5844|2-Sided|95.0|-0.32|0.56|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679159|NCT01258738|3088887|Superiority or Other||Mean Difference (Final Values)|0.13||||0.511|2-Sided|95.0|-0.25|0.51|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679160|NCT01258738|3088887|Superiority or Other||Mean Difference (Final Values)|0.17||||0.4029|2-Sided|95.0|-0.23|0.58|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679161|NCT01258738|3088887|Superiority or Other||Mean Difference (Final Values)|0.22||||0.2823|2-Sided|95.0|-0.18|0.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679162|NCT01258738|3088887|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679163|NCT01258738|3088888|Superiority or Other||Mean Difference (Final Values)|1.45||||0.3985|2-Sided|95.0|-1.93|4.82|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679164|NCT01258738|3088888|Superiority or Other||Mean Difference (Final Values)|2.26||||0.1754|2-Sided|95.0|-1.02|5.53|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679165|NCT01258738|3088888|Superiority or Other||Mean Difference (Final Values)|2.85||||0.0543|2-Sided|95.0|-0.05|5.75|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679166|NCT01258738|3088888|Superiority or Other||Mean Difference (Final Values)|0.89||||0.4556|2-Sided|95.0|-1.46|3.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679167|NCT01258738|3088888|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679168|NCT01258738|3088889|Superiority or Other||Mean Difference (Final Values)|0.01||||0.9712|2-Sided|95.0|-0.6|0.62|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679169|NCT01258738|3088889|Superiority or Other||Mean Difference (Final Values)|0.03||||0.8999|2-Sided|95.0|-0.47|0.54|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679170|NCT01258738|3088889|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.4971|2-Sided|95.0|-0.7|0.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679171|NCT01258738|3088889|Superiority or Other||Mean Difference (Final Values)|0.01||||0.9504|2-Sided|95.0|-0.46|0.49|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679172|NCT01258738|3088889|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679173|NCT01258738|3088890|Superiority or Other||Mean Difference (Final Values)|2.39||||0.1095|2-Sided|95.0|-0.54|5.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679174|NCT01258738|3088890|Superiority or Other||Mean Difference (Final Values)|1.06||||0.443|2-Sided|95.0|-1.67|3.79|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679175|NCT01258738|3088890|Superiority or Other||Mean Difference (Final Values)|1.03||||0.4178|2-Sided|95.0|-1.48|3.55|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679176|NCT01258738|3088890|Superiority or Other||Mean Difference (Final Values)|0.37||||0.7645|2-Sided|95.0|-2.06|2.8|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679177|NCT01258738|3088890|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679178|NCT01258738|3088891|Superiority or Other||Mean Difference (Final Values)|1.21||||0.0488|2-Sided|95.0|0.03|2.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679179|NCT01258738|3088891|Superiority or Other||Mean Difference (Final Values)|0.74||||0.1558|2-Sided|95.0|-0.28|1.75|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679180|NCT01258738|3088891|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9947|2-Sided|95.0|-0.98|0.98|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679181|NCT01258738|3088891|Superiority or Other||Mean Difference (Final Values)|0.37||||0.4332|2-Sided|95.0|-0.57|1.32|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679182|NCT01258738|3088891|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679183|NCT01258738|3088892|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.6871|2-Sided|95.0|-0.35|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679184|NCT01258738|3088892|Superiority or Other||Mean Difference (Final Values)|0.04||||0.7468|2-Sided|95.0|-0.22|0.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679185|NCT01258738|3088892|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.3896|2-Sided|95.0|-0.33|0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679186|NCT01258738|3088892|Superiority or Other||Mean Difference (Final Values)|0.05||||0.6741|2-Sided|95.0|-0.18|0.28|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679187|NCT01258738|3088892|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test, after Week 24. For label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679253|NCT01258738|3088906|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679188|NCT01258738|3088893|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.0558|2-Sided|95.0|-1.02|0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 12|
1679189|NCT01258738|3088893|Superiority or Other||Mean Difference (Final Values)|-0.54||||0.0201|2-Sided|95.0|-0.99|-0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 4 and 12 data only. Week 4|
1679190|NCT01258738|3088893|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679191|NCT01258738|3088894|Superiority or Other||Mean Difference (Final Values)|15.29||||0.0174|2-Sided|95.0|2.28|28.3|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679192|NCT01258738|3088894|Superiority or Other||Mean Difference (Final Values)|13.99||||0.0278|2-Sided|95.0|0.72|27.26|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679193|NCT01258738|3088894|Superiority or Other||Mean Difference (Final Values)|8.57||||0.195|2-Sided|95.0|-4.39|21.54|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679194|NCT01258738|3088894|Superiority or Other||Mean Difference (Final Values)|7.88||||0.2755|2-Sided|95.0|-5.15|20.92|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679195|NCT01258738|3088895|Superiority or Other||Mean Difference (Final Values)|15.12||||0.0213|2-Sided|95.0|3.04|27.2|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679196|NCT01258738|3088895|Superiority or Other||Mean Difference (Final Values)|13.75||||0.012|2-Sided|95.0|3.62|23.89|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679197|NCT01258738|3088895|Superiority or Other||Mean Difference (Final Values)|11.59||||0.01|2-Sided|95.0|3.18|19.99|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679198|NCT01258738|3088895|Superiority or Other||Mean Difference (Final Values)|19.96||||0.0029|2-Sided|95.0|7.54|32.37|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679199|NCT01258738|3088896|Superiority or Other||Mean Difference (Final Values)|-0.87||||0.012|2-Sided|95.0|-1.54|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679200|NCT01258738|3088896|Superiority or Other||Mean Difference (Final Values)|-0.85||||0.0094|2-Sided|95.0|-1.48|-0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679201|NCT01258738|3088896|Superiority or Other||Mean Difference (Final Values)|-0.81||||0.0073|2-Sided|95.0|-1.39|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679202|NCT01258738|3088896|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.0007|2-Sided|95.0|-1.56|-0.43|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679203|NCT01258738|3088896|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679204|NCT01258738|3088897|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.0634|2-Sided|95.0|-1.24|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679205|NCT01258738|3088897|Superiority or Other||Mean Difference (Final Values)|-0.68||||0.034|2-Sided|95.0|-1.3|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679206|NCT01258738|3088897|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.0345|2-Sided|95.0|-1.28|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679207|NCT01258738|3088897|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.4559|2-Sided|95.0|-0.84|0.38|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679208|NCT01258738|3088897|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679209|NCT01258738|3088898|Superiority or Other||Mean Difference (Final Values)|-1.02||||0.0008|2-Sided|95.0|-1.61|-0.43|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679210|NCT01258738|3088898|Superiority or Other||Mean Difference (Final Values)|-0.94||||0.0017|2-Sided|95.0|-1.53|-0.36|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679211|NCT01258738|3088898|Superiority or Other||Mean Difference (Final Values)|-0.71||||0.0139|2-Sided|95.0|-1.27|-0.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679212|NCT01258738|3088898|Superiority or Other||Mean Difference (Final Values)|-0.46||||0.0928|2-Sided|95.0|-1.0|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679213|NCT01258738|3088898|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679214|NCT01258738|3088899|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.239|2-Sided|95.0|-1.04|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679215|NCT01258738|3088899|Superiority or Other||Mean Difference (Final Values)|-0.71||||0.0277|2-Sided|95.0|-1.34|-0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679216|NCT01258738|3088899|Superiority or Other||Mean Difference (Final Values)|-0.54||||0.0866|2-Sided|95.0|-1.17|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679217|NCT01258738|3088899|Superiority or Other||Mean Difference (Final Values)|-0.33||||0.2688|2-Sided|95.0|-0.92|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679218|NCT01258738|3088899|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679219|NCT01258738|3088900|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.2425|2-Sided|95.0|-1.03|0.26|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679220|NCT01258738|3088900|Superiority or Other||Mean Difference (Final Values)|-0.68||||0.0216|2-Sided|95.0|-1.27|-0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679221|NCT01258738|3088900|Superiority or Other||Mean Difference (Final Values)|-0.45||||0.0973|2-Sided|95.0|-0.99|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679222|NCT01258738|3088900|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.0316|2-Sided|95.0|-1.09|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679223|NCT01258738|3088900|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679224|NCT01258738|3088901|Superiority or Other||Mean Difference (Final Values)|-0.83||||0.0134|2-Sided|95.0|-1.49|-0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679225|NCT01258738|3088901|Superiority or Other||Mean Difference (Final Values)|-1.23||||0.0002|2-Sided|95.0|-1.85|-0.6|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679226|NCT01258738|3088901|Superiority or Other||Mean Difference (Final Values)|-0.83||||0.0064|2-Sided|95.0|-1.42|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679227|NCT01258738|3088901|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.0058|2-Sided|95.0|-1.37|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679228|NCT01258738|3088901|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679229|NCT01258738|3088902|Superiority or Other||Mean Difference (Final Values)|-0.81||||0.0016|2-Sided|95.0|-1.31|-0.31|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679230|NCT01258738|3088902|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.0048|2-Sided|95.0|-1.11|-0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679231|NCT01258738|3088902|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.0106|2-Sided|95.0|-1.01|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679232|NCT01258738|3088902|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.0186|2-Sided|95.0|-1.18|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679233|NCT01258738|3088902|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679234|NCT01258738|3088903|Superiority or Other||Mean Difference (Final Values)|-0.45||||0.0975|2-Sided|95.0|-0.99|0.08|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679235|NCT01258738|3088903|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.0728|2-Sided|95.0|-1.04|0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679236|NCT01258738|3088903|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.1538|2-Sided|95.0|-0.96|0.15|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679237|NCT01258738|3088903|Superiority or Other||Mean Difference (Final Values)|-0.46||||0.0826|2-Sided|95.0|-0.98|0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679238|NCT01258738|3088903|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679239|NCT01258738|3088904|Superiority or Other||Mean Difference (Final Values)|-0.58||||0.0379|2-Sided|95.0|-1.12|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679240|NCT01258738|3088904|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.175|2-Sided|95.0|-0.91|0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679241|NCT01258738|3088904|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.0455|2-Sided|95.0|-1.09|-0.01|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679242|NCT01258738|3088904|Superiority or Other||Mean Difference (Final Values)|-0.75||||0.0044|2-Sided|95.0|-1.27|-0.24|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679243|NCT01258738|3088904|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679244|NCT01258738|3088905|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.2271|2-Sided|95.0|-0.94|0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679245|NCT01258738|3088905|Superiority or Other||Mean Difference (Final Values)|-0.44||||0.1181|2-Sided|95.0|-0.98|0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679246|NCT01258738|3088905|Superiority or Other||Mean Difference (Final Values)|-0.54||||0.0389|2-Sided|95.0|-1.06|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679247|NCT01258738|3088905|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.108|2-Sided|95.0|-0.9|0.09|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679248|NCT01258738|3088905|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679249|NCT01258738|3088906|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.1891|2-Sided|95.0|-0.99|0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679250|NCT01258738|3088906|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.3221|2-Sided|95.0|-0.87|0.29|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679251|NCT01258738|3088906|Superiority or Other||Mean Difference (Final Values)|-0.33||||0.2299|2-Sided|95.0|-0.88|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679252|NCT01258738|3088906|Superiority or Other||Mean Difference (Final Values)|-0.41||||0.141|2-Sided|95.0|-0.96|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679254|NCT01258738|3088907|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.2186|2-Sided|95.0|-0.9|0.21|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679255|NCT01258738|3088907|Superiority or Other||Mean Difference (Final Values)|-0.48||||0.0797|2-Sided|95.0|-1.03|0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679256|NCT01258738|3088907|Superiority or Other||Mean Difference (Final Values)|-0.56||||0.0384|2-Sided|95.0|-1.09|-0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679257|NCT01258738|3088907|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.243|2-Sided|95.0|-0.79|0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679258|NCT01258738|3088907|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679259|NCT01258738|3088908|Superiority or Other||Mean Difference (Final Values)|-0.51||||0.0509|2-Sided|95.0|-1.02|0.0|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679260|NCT01258738|3088908|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.0512|2-Sided|95.0|-1.0|0.0|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679261|NCT01258738|3088908|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.1145|2-Sided|95.0|-0.93|0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679262|NCT01258738|3088908|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.2268|2-Sided|95.0|-0.8|0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679263|NCT01258738|3088908|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679264|NCT01258738|3088909|Superiority or Other||Mean Difference (Final Values)|-0.78||||0.006|2-Sided|95.0|-1.33|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679265|NCT01258738|3088909|Superiority or Other||Mean Difference (Final Values)|-0.71||||0.0104|2-Sided|95.0|-1.26|-0.17|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679266|NCT01258738|3088909|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.0044|2-Sided|95.0|-1.35|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679267|NCT01258738|3088909|Superiority or Other||Mean Difference (Final Values)|-0.75||||0.0037|2-Sided|95.0|-1.26|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679268|NCT01258738|3088909|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679269|NCT01258738|3088910|Superiority or Other||Mean Difference (Final Values)|-0.72||||0.0098|2-Sided|95.0|-1.26|-0.18|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679270|NCT01258738|3088910|Superiority or Other||Mean Difference (Final Values)|-0.52||||0.0659|2-Sided|95.0|-1.07|0.03|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679271|NCT01258738|3088910|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.0284|2-Sided|95.0|-1.14|-0.06|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679272|NCT01258738|3088910|Superiority or Other||Mean Difference (Final Values)|-0.41||||0.1413|2-Sided|95.0|-0.95|0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679273|NCT01258738|3088910|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679274|NCT01258738|3088911|Superiority or Other||Mean Difference (Final Values)|-0.49||||0.0866|2-Sided|95.0|-1.05|0.07|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679275|NCT01258738|3088911|Superiority or Other||Mean Difference (Final Values)|-0.69||||0.0153|2-Sided|95.0|-1.25|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679276|NCT01258738|3088911|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.1618|2-Sided|95.0|-0.97|0.16|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679277|NCT01258738|3088911|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.0173|2-Sided|95.0|-1.19|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679278|NCT01258738|3088911|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679279|NCT01258738|3088912|Superiority or Other||Mean Difference (Final Values)|-0.95||||0.001|2-Sided|95.0|-1.52|-0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679280|NCT01258738|3088912|Superiority or Other||Mean Difference (Final Values)|-0.75||||0.0056|2-Sided|95.0|-1.28|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679281|NCT01258738|3088912|Superiority or Other||Mean Difference (Final Values)|-0.67||||0.0147|2-Sided|95.0|-1.21|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679282|NCT01258738|3088912|Superiority or Other||Mean Difference (Final Values)|-0.78||||0.0029|2-Sided|95.0|-1.28|-0.27|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679283|NCT01258738|3088912|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679284|NCT01258738|3088913|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.0166|2-Sided|95.0|-0.99|-0.1|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679285|NCT01258738|3088913|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.0127|2-Sided|95.0|-0.99|-0.12|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679286|NCT01258738|3088913|Superiority or Other||Mean Difference (Final Values)|-0.54||||0.0095|2-Sided|95.0|-0.95|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679287|NCT01258738|3088913|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.0164|2-Sided|95.0|-1.04|-0.11|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679288|NCT01258738|3088913|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679289|NCT01258738|3088914|Superiority or Other||Mean Difference (Final Values)|-1.01||||0.0021|2-Sided|95.0|-1.65|-0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679290|NCT01258738|3088914|Superiority or Other||Mean Difference (Final Values)|-0.64||||0.0349|2-Sided|95.0|-1.24|-0.05|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679291|NCT01258738|3088914|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.0407|2-Sided|95.0|-1.12|-0.02|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679292|NCT01258738|3088914|Superiority or Other||Mean Difference (Final Values)|-0.87||||0.0064|2-Sided|95.0|-1.49|-0.25|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679293|NCT01258738|3088914|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679294|NCT01258738|3088915|Superiority or Other||Mean Difference (Final Values)|-0.97||||0.0031|2-Sided|95.0|-1.61|-0.33|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679295|NCT01258738|3088915|Superiority or Other||Mean Difference (Final Values)|-0.82||||0.0101|2-Sided|95.0|-1.45|-0.2|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679296|NCT01258738|3088915|Superiority or Other||Mean Difference (Final Values)|-0.79||||0.0097|2-Sided|95.0|-1.38|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679297|NCT01258738|3088915|Superiority or Other||Mean Difference (Final Values)|-0.93||||0.0091|2-Sided|95.0|-1.62|-0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679298|NCT01258738|3088915|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679299|NCT01258738|3088916|Superiority or Other||Mean Difference (Final Values)|-0.83||||0.0077|2-Sided|95.0|-1.44|-0.22|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679300|NCT01258738|3088916|Superiority or Other||Mean Difference (Final Values)|-0.79||||0.0057|2-Sided|95.0|-1.35|-0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679301|NCT01258738|3088916|Superiority or Other||Mean Difference (Final Values)|-0.92||||0.0007|2-Sided|95.0|-1.44|-0.39|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679302|NCT01258738|3088916|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.0102|2-Sided|95.0|-1.4|-0.19|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679303|NCT01258738|3088916|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results included unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679304|NCT01258738|3088917|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.2678|2-Sided|95.0|-0.81|0.23|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679305|NCT01258738|3088917|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.0936|2-Sided|95.0|-0.91|0.07|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679306|NCT01258738|3088917|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.0111|2-Sided|95.0|-1.06|-0.14|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679307|NCT01258738|3088917|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.0156|2-Sided|95.0|-1.26|-0.13|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679308|NCT01258738|3088917|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679309|NCT01258738|3088918|Superiority or Other|||||||0.0022|||||||Log Rank|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 12 data only."|
1679310|NCT01258738|3088919|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679311|NCT01258738|3088919|Superiority or Other||Mean Difference (Final Values)|12.73|||<|0.0141|2-Sided|95.0|3.14|22.32|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679312|NCT01258738|3088919|Superiority or Other||Mean Difference (Final Values)|6.81|||<|0.0611|2-Sided|95.0|-0.03|13.65|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679313|NCT01258738|3088919|Superiority or Other||Mean Difference (Final Values)|8.65|||<|0.0179|2-Sided|95.0|1.82|15.48|||Cochran-Mantel-Haenszel|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only.~Week 2"|
1679314|NCT01258738|3088919|Superiority or Other||Mean Difference (Final Values)|12.84|||<|0.0209|2-Sided|95.0|2.58|23.09|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679315|NCT01258738|3088920|Superiority or Other||Mean Difference (Final Values)|-0.61|||<|0.001|2-Sided|95.0|-0.85|-0.37|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679316|NCT01258738|3088920|Superiority or Other||Mean Difference (Final Values)|-0.61|||<|0.001|2-Sided|95.0|-0.81|-0.41|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679317|NCT01258738|3088920|Superiority or Other||Mean Difference (Final Values)|-0.54|||<|0.001|2-Sided|95.0|-0.74|-0.34|||ANCOVA|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679318|NCT01258738|3088920|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All within group comparisons to baseline were <0.001, from paired t-test. For open-label period results include unadjusted mean changes and standard errors, no covariate adjustments were applied.|
1679365|NCT01257542|3089060|Superiority or Other||Mean Difference (Final Values)|0.09||||0.523|2-Sided|95.0|-0.21|0.39||p-value was calculated from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores controlling site.|Cochran-Mantel-Haenszel|||Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.|
1679319|NCT01258738|3088921|Superiority or Other||Mean Difference (Final Values)|21.79|||<|0.0001|2-Sided|95.0|10.92|32.67|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679320|NCT01258738|3088921|Superiority or Other||Mean Difference (Final Values)|14.89|||<|0.002|2-Sided|95.0|5.18|24.6|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679321|NCT01258738|3088921|Superiority or Other||Mean Difference (Final Values)|12.83|||<|0.0021|2-Sided|95.0|5.09|20.57|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679322|NCT01258738|3088921|Superiority or Other||Mean Difference (Final Values)|22.63|||<|0.0001|2-Sided|95.0|11.85|33.41|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679323|NCT01258738|3088922|Superiority or Other||Mean Difference (Final Values)|16.27||||0.0195|2-Sided|95.0|3.1|29.43|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679324|NCT01258738|3088922|Superiority or Other||Mean Difference (Final Values)|10.61||||0.0867|2-Sided|95.0|-2.63|23.84|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679325|NCT01258738|3088922|Superiority or Other||Mean Difference (Final Values)|10.29||||0.0983|2-Sided|95.0|-2.17|22.75|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4|
1679326|NCT01258738|3088922|Superiority or Other||Mean Difference (Final Values)|14.44||||0.0189|2-Sided|95.0|3.2|25.68|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679327|NCT01258738|3088923|Superiority or Other||Mean Difference (Final Values)|18.52||||0.0023|2-Sided|95.0|7.29|29.75|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 12|
1679328|NCT01258738|3088923|Superiority or Other||Mean Difference (Final Values)|12.83||||0.0304|2-Sided|95.0|1.79|23.87|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 8|
1679329|NCT01258738|3088923|Superiority or Other||Mean Difference (Final Values)|5.19||||0.3786|2-Sided|95.0|-4.98|15.35|||Cochran-Mantel-Haenszel|||"Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made.~Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 4"|
1679330|NCT01258738|3088923|Superiority or Other||Mean Difference (Final Values)|11.46||||0.0059|2-Sided|95.0|3.69|19.24|||Cochran-Mantel-Haenszel|||Secondary and supportive analyses were performed at 2-sided alpha = 0.05 significance level. No adjustment for multiple testing was made. Comparative analysis was carried out for Week 2, 4, 8, 12 data only. Week 2|
1679331|NCT01258738|3088924|Superiority or Other||Mean Difference (Final Values)|16.64||||0.0062|2-Sided|95.0|5.36|27.92||P-value <0.05 was required to declare statistical significance.|Cochran-Mantel-Haenszel|||"The null hypothesis was that the efficacy of etanercept was not different from placebo as measured by the proportion of subjects achieving an ASAS 40 response after 12 weeks of treatment. The alternative hypothesis was that the efficacy of etanercept was different from placebo.~The primary endpoint was tested at 2-sided alpha = 0.05 significance level. Comparative analysis was carried out for Week 12 data only."|
1679332|NCT01258608|3088946|Other||Disease control rate difference|-5.8||||0.6558|2-Sided|95.0|-25.4|13.8||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact||||
1679333|NCT01258608|3088947|Other||Disease control rate difference|-20.7||||0.0198|2-Sided|95.0|-40.8|1.8||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact||||
1679334|NCT01258608|3088948|Other||Response rate difference|6.7||||0.3479|2-Sided|95.0|-13.4|26.2||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact||||
1679335|NCT01258608|3088949|Other||Response rate difference|5.4||||0.5458|2-Sided|95.0|-16.8|26.6||Nominal P-value for comparison of treatment groups obtained from Fisher's exact test.|Fisher Exact||||
1679336|NCT01258608|3088950|Other||Hazard Ratio (HR)|0.909||||0.3088|1-Sided|90.0||1.191||P-value for comparison of treatment groups obtained from stratified log-rank test - stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing Mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.||
1679337|NCT01258608|3088951|Other||Hazard Ratio (HR)|1.066||||0.6925|1-Sided|90.0||1.43||P-value for comparison of treatment groups obtained from stratified log-rank test - stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing Mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.||
1679338|NCT01258608|3088952|Other||Hazard Ratio (HR)|1.007||||0.6121|1-Sided|90.0||1.346||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and ECOG performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.||
1679339|NCT01258608|3088953|Other||Hazard Ratio (HR)|0.922||||0.3156|1-Sided|90.0||1.288||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and Eastern Cooperative Oncology Group (ECOG) performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.||
1679340|NCT01258608|3088954|Other||Hazard Ratio (HR)|1.192||||0.7382|1-Sided|90.0||1.737||P-value for comparison of treatment groups obtained from stratified log-rank test-stratified by Barcelona Clinic Liver Cancer and Eastern Cooperative Oncology Group (ECOG) performance status.|Stratified log-rank test||Hazard ratio comparing mapatumumab to placebo obtained from Cox proportional hazards model with covariate adjustment for Barcelona Clinic Liver Cancer and ECOG performance status.||
1679341|NCT01258582|3088960|Superiority or Other||difference in the acceptance rates|-0.022||||0.34|2-Sided|95.0|-0.067|0.023|||Chi-squared|The difference in the acceptance rates was estimated along with 95% confidence intervals and tested using the chi-square test.||Sample size was chosen to detect a 10% difference in acceptance rates between two testing modality arms (90% power, 0.05 level of significance).|
1679342|NCT01258374|3088970|Other||||||<|0.01||||||The PK paramaters reported as geometric means, were calculated using noncompartmental modelinf techniques (WinNolin; Pharsight Corporation, Mountain View, CA)|Noncompartmental modeling techniques||||The pharmacokinetic parameters calculated for DRV, RTV and RAL were trough plasma concentration (C trough), defined as the concentration at 24 or 12 h after observed dose, the maximum observed plasma concentration (C max), the area under the plasma concentration-time curve from 0 to 24 H (AUC 0-24) or 0 to 12 h (AUC 0-12) and the elimination half-life (t1/2). AUC and t1/2 were calculated using non using noncompartmental modeling techniques (WinNolin; Pharsight Corporation, Mountain View, CA). All of these PK parameters are reported as geometric means.
1679343|NCT01258101|3088983|Superiority or Other|||||||0.9891|||||||Regression, Cox||||
1679344|NCT01258101|3088983|Superiority or Other|||||||0.9999|||||||Regression, Cox||||
1679345|NCT01258101|3088983|Superiority or Other||Hazard Ratio (HR)|0.629||||0.2667|2-Sided||||||Regression, Cox||||
1679346|NCT01258101|3088991|Non-Inferiority or Equivalence|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|0.6|||||2-Sided|95.0|-0.5|1.7|||||||
1679347|NCT01258101|3088991|Non-Inferiority or Equivalence|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 800 mg (16 weeks).|Risk Difference (RD)|0.0|||||2-Sided|95.0|-1.4|1.4|||||||
1679348|NCT01258101|3088991|Non-Inferiority or Equivalence|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (24 weeks).|Risk Difference (RD)|-2.6|||||2-Sided|95.0|-6.4|1.3|||||||
1679349|NCT01258101|3088991|Non-Inferiority or Equivalence|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (16 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|-0.4|||||2-Sided|95.0|-1.0|0.2|||||||
1679350|NCT01258101|3088993|Non-Inferiority or Equivalence|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|-21.1|||||2-Sided|95.0|-42.2|-0.1|||||||
1679351|NCT01258101|3088993|Non-Inferiority or Equivalence|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 800 mg (16 weeks).|Risk Difference (RD)|7.2|||||2-Sided|95.0|-4.7|19.1|||||||
1679352|NCT01258101|3088993|Non-Inferiority or Equivalence|The statistical analysis was applied to arms Peginterferon/Ribavirin 800 mg (24 weeks) and Peginterferon/Ribavirin 400 mg (24 weeks).|Risk Difference (RD)|-3.2|||||2-Sided|95.0|-14.0|7.6|||||||
1679353|NCT01258101|3088993|Non-Inferiority or Equivalence|The statistical analysis was applied to Arms Peginterferon/Ribavirin 800 mg (16 weeks) and Peginterferon/Ribavirin 400 mg (16 weeks).|Risk Difference (RD)|32.0|||||2-Sided|95.0|10.5|53.5|||||||
1679354|NCT01258049|3088999|Superiority or Other||Percentage Difference|55.01|||<|0.005|2-Sided|95.0|42.44|67.58|||Regression, Linear||||
1679355|NCT01258049|3089002|Superiority or Other||Percentage Difference|0.99||||0.99|2-Sided|95.0|0.42|2.36|||Regression, Logistic||||
1679356|NCT01258049|3089003|Superiority or Other||Mean Difference (Final Values)|0.96||||0.86|2-Sided|95.0|-10.16|12.08|||Regression, Cox||||
1679357|NCT01258049|3089004|Superiority or Other||Mean Difference (Final Values)|174.09||||0.06|2-Sided|95.0|-10.44|358.61|||ANCOVA||mean parasite counts increased in the first 12 hours for patients on quinine treatment||
1679358|NCT01258049|3089005|Superiority or Other||Mean Difference (Final Values)|54.02|||<|0.005|2-Sided|95.0|27.05|80.98|||ANCOVA||||
1679359|NCT01258049|3089006|Superiority or Other||Mean Difference (Final Values)|-9.16|||<|0.005|2-Sided|95.0|-11.71|0.0|||Regression, Cox||||
1679360|NCT01258049|3089007|Superiority or Other||Mean Difference (Final Values)|-12.91|||<|0.005|2-Sided|95.0|-17.38|-8.44|||ANCOVA||||
1679361|NCT01258049|3089008|Superiority or Other||Mean Difference (Final Values)|-38.97|||<|0.05|2-Sided|95.0|-62.22|-15.72|||ANCOVA||||
1679362|NCT01258049|3089009|Superiority or Other||Percentage Difference|54.85|||<|0.005|2-Sided|95.0|42.25|67.45|||Regression, Logistic|||In ART003, the parasite success rate for quinine was 67.7%. On the assumption that the parasite success rate was 70% for quinine in this study and in order to demonstrate that ArTiMist™ is superior to quinine by at least 20% the success rate for ArTiMist™ should be at least 90%. Using these figures, and assuming a power of 80%, an alpha of 0.05 (two sided) and based on an equal allocation to the ArTiMist™ and quinine treatment arms, the number of subjects (n) required on each treatment was 59.|
1679363|NCT01257880|3089015|Superiority or Other|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney U test was used to test the null hypothesis that basilar artery vasomotor reactivity was equivalent between the two groups.|
1679364|NCT01257542|3089059|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.796|2-Sided|95.0|-0.35|0.24||p-value was calculated from the CMH test with modified ridit scores controlling site.|Cochran-Mantel-Haenszel|||Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.|
1679396|NCT01257503|3089069|Superiority or Other|||||||0.81|||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in appetite|
1679366|NCT01257542|3089061|Superiority or Other||LS mean difference|-0.84||||0.179|2-Sided|95.0|-2.06|0.39||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.|
1679367|NCT01257542|3089061|Superiority or Other||LS mean difference|-0.69||||0.204|2-Sided|95.0|-1.75|0.38||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.|
1679368|NCT01257542|3089061|Superiority or Other||LS mean difference|-0.49||||0.402|2-Sided|95.0|-1.63|0.66||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.|
1679369|NCT01257542|3089061|Superiority or Other||LS mean difference|-0.45||||0.396|2-Sided|95.0|-1.49|0.6||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.|
1679370|NCT01257542|3089061|Superiority or Other||LS mean difference|-0.44||||0.426|2-Sided|95.0|-1.54|0.65||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.|
1679371|NCT01257542|3089061|Superiority or Other||LS mean difference|-0.03||||0.954|2-Sided|95.0|-1.03|0.97||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.|
1679372|NCT01257542|3089062|Superiority or Other||LS mean difference|-0.49||||0.304|2-Sided|95.0|-1.43|0.45||p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.|ANOVA|||Treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.|
1679373|NCT01257542|3089063|Superiority or Other||LS mean difference|-0.29||||0.206|2-Sided|95.0|-0.75|0.16||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.|
1679374|NCT01257542|3089063|Superiority or Other||LS mean difference|-0.46||||0.039|2-Sided|95.0|-0.9|-0.02||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.|
1679375|NCT01257542|3089063|Superiority or Other||LS mean difference|-0.21||||0.364|2-Sided|95.0|-0.68|0.25||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.|
1679376|NCT01257542|3089063|Superiority or Other||LS mean difference|-0.32||||0.139|2-Sided|95.0|-0.74|0.1||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.|
1679377|NCT01257542|3089063|Superiority or Other||LS mean difference|-0.2||||0.358|2-Sided|95.0|-0.64|0.23||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.|
1679378|NCT01257542|3089063|Superiority or Other||LS mean difference|-0.06||||0.768|2-Sided|95.0|-0.45|0.33||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.|
1679379|NCT01257542|3089064|Superiority or Other||LS mean difference|-0.26||||0.134|2-Sided|95.0|-0.6|0.08||p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.|ANOVA|||Treatment difference and corresponding 95% CI were calculated based on least-square (LS) means from analysis of variance (ANOVA) model.|
1679380|NCT01257542|3089065|Superiority or Other||Odds Ratio (OR)|0.83||||0.252|2-Sided|95.0|0.59|1.15||p-value was calculated using negative binomial regression model with treatment, site and baseline of cough count terms with log (exposure time) as the offset parameter.|Negative binomial regression|||Odds Ratio and corresponding 95 percent (%) confidence interval (CI) were assessed from the negative binomial regression model.|
1679381|NCT01257503|3089066|Superiority or Other|||||||0.36|||||||Wilcoxon (Mann-Whitney)|||cold score at 7-10 day follow-up|
1679382|NCT01257503|3089066|Superiority or Other|||||||0.35|||||||Wilcoxon (Mann-Whitney)|||cold score day 3 assessment 2|
1679383|NCT01257503|3089066|Superiority or Other|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||cold score day 3 assessment 1|
1679384|NCT01257503|3089066|Superiority or Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||cold score day 2 assessment 2|
1679385|NCT01257503|3089066|Superiority or Other|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||day 2 assessment 1|
1679386|NCT01257503|3089066|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||cold score day 1 assessment 2|
1679387|NCT01257503|3089066|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||cold score day 1 assessment 1|
1679388|NCT01257503|3089067|Superiority or Other|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||health status at follow-up|
1679389|NCT01257503|3089067|Superiority or Other|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||health status day 3|
1679390|NCT01257503|3089067|Superiority or Other|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||health status day 2|
1679391|NCT01257503|3089067|Superiority or Other|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||health status day 1|
1679392|NCT01257503|3089068|Superiority or Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||functional status at 7-10 day follow-up|
1679393|NCT01257503|3089068|Superiority or Other|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||functional status day 3|
1679394|NCT01257503|3089068|Superiority or Other|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||functional status day 2|
1679395|NCT01257503|3089068|Superiority or Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)|||functional status day 1|
1679398|NCT01257503|3089069|Superiority or Other|||||||0.97|||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in lethargy|
1679399|NCT01257503|3089069|Superiority or Other|||||||0.61|||||||Regression, Linear|Generalized estimating equations used to account for multiple doses in single participant.||change in irritability|
1679400|NCT01257503|3089070|Superiority or Other|||||||0.82|||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in congestion|
1679401|NCT01257503|3089070|Superiority or Other|||||||0.45|||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in cough|
1679402|NCT01257503|3089070|Superiority or Other|||||||0.89|||||||Regression, Linear|generalized estimating equations used to account for multiple doses in single participant||change in sneeze|
1679403|NCT01257503|3089070|Superiority or Other|||||||0.86|||||||Regression, Linear|generalized estimating equations used to account for multiple doses in same participant||change in runny nose|
1679404|NCT01257438|3089072|Non-Inferiority or Equivalence|The p-value is based on a non-inferiority Farrington and Manning Exact Test. The non-inferiority margin is 0.075 (or 7.5%).||||||0.007|||||||Farrington and Manning Exact Test|The non-inferiority margin is 0.075 (or 7.5%)|||
1679405|NCT01257438|3089073|Superiority or Other||Greenwood’s estimate of variance|0.59|||<|0.001|2-Sided|95.0|0.44|0.79|||Log Rank|||Subjects at risk (at 6 months) is a calculation in Kaplan-Meier time-to-event analyses that refers to subjects who have not had ACPP failure through the 6 months (i.e., are event-free through 6 months).|
1679406|NCT01257425|3089074|Superiority or Other|||||||0.84|||||||Log Rank||||
1679407|NCT01257425|3089075|Superiority or Other|||||||0.98|||||||Log Rank||||
1679408|NCT01257425|3089076|Superiority or Other||Mean Difference (Net)|0.01||||0.85|2-Sided|95.0|-0.09|0.11|||ANCOVA||||
1679409|NCT01257425|3089078|Non-Inferiority or Equivalence|Equivalence margin is 0.8 to 1.25|Ratio of AUC values|0.91|||||2-Sided|90.0|0.81|1.02|||||||
1679410|NCT01257425|3089079|Non-Inferiority or Equivalence|Equivalence margin is 0.8 to 1.25|Ratio of AUC values|0.932|||||2-Sided|90.0|0.82|1.06|||||||
1679411|NCT01257425|3089080|Non-Inferiority or Equivalence|Equivalence margin defined as 0.8 to 1.25|Ratio of AUC values|0.977|||||2-Sided|90.0|0.88|1.08|||||||
1679412|NCT01257347|3089084|Superiority or Other||||||<=|0||||||We included a stopping rule in which recruitment would be stopped at the midpoint for futility if the z-score was negative or for efficacy if the z-score was positive and the p-value ≤ 0.001.|GEE model|GEE models (logit link) with clinician as the cluster variable, appropriateness of management as outcome, intervention group as explanatory variable.||The sample size was calculated to have sufficient power to detect meaningful differences in appropriateness of clinician management between intervention and control groups. Each patient-clinician encounter was treated as independent and the sample size was inflated to account for the design effect (DE) of clustering of patients within clinician. GEE stands for generalized estimating equation.|
1679413|NCT01257230|3089085|Superiority or Other||Hazard Ratio (HR)|0.82||||0.4198|2-Sided|95.0|0.51|1.33|||Regression, Cox||||
1679414|NCT01257230|3089085|Superiority or Other||Hazard Ratio (HR)|1.04||||0.87|2-Sided|95.0|0.65|1.66|||Regression, Cox||||
1679415|NCT01257230|3089086|Superiority or Other||Hazard Ratio (HR)|0.23||||0.062|2-Sided|95.0|0.05|1.08|||Regression, Cox||||
1679416|NCT01257230|3089086|Superiority or Other||Hazard Ratio (HR)|0.63||||0.4023|2-Sided|95.0|0.21|1.87|||Regression, Cox||||
1679417|NCT01257230|3089088|Superiority or Other||Mean Difference (Final Values)|-0.054|Standard Error of the Mean|0.092||0.5589|2-Sided|95.0|-0.235|0.127|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1679418|NCT01257230|3089088|Superiority or Other||Mean Difference (Final Values)|-0.147|Standard Error of the Mean|0.095||0.12|2-Sided|95.0|-0.333|0.038|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1679419|NCT01257230|3089090|Superiority or Other||Mean Difference (Final Values)|-0.097|Standard Error of the Mean|0.084||0.2516|2-Sided|95.0|-0.263|0.069|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1679420|NCT01257230|3089090|Superiority or Other||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.087||0.0653|2-Sided|95.0|-0.33|0.01|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1679421|NCT01257230|3089091|Superiority or Other||Mean Difference (Final Values)|0.044|Standard Error of the Mean|0.14||0.7559|2-Sided|95.0|-0.232|0.319|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1679422|NCT01257230|3089091|Superiority or Other||Mean Difference (Final Values)|-0.032|Standard Error of the Mean|0.143||0.8253|2-Sided|95.0|-0.312|0.249|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1679423|NCT01257230|3089092|Superiority or Other||Mean Difference (Final Values)|0.112|Standard Error of the Mean|0.081||0.1649|2-Sided|95.0|-0.046|0.271|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1679424|NCT01257230|3089092|Superiority or Other||Mean Difference (Final Values)|0.023|Standard Error of the Mean|0.083||0.7852|2-Sided|95.0|-0.14|0.185|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1679425|NCT01257230|3089093|Superiority or Other||Mean Difference (Final Values)|-0.009|Standard Error of the Mean|0.09||0.9224|2-Sided|95.0|-0.186|0.168|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1679426|NCT01257230|3089093|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.092||0.976|2-Sided|95.0|-0.184|0.178|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1679427|NCT01257230|3089095|Superiority or Other||Mean Difference (Final Values)|0.071|Standard Error of the Mean|0.053||0.1755|2-Sided|95.0|-0.032|0.175|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1679428|NCT01257230|3089095|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.054||0.0945|2-Sided|95.0|-0.016|0.196|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1679429|NCT01257230|3089096|Superiority or Other||Mean Difference (Final Values)|0.181|Standard Error of the Mean|0.048||0.0002|2-Sided|95.0|0.088|0.275|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1679430|NCT01257230|3089096|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.049||0.0079|2-Sided|95.0|0.034|0.225|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1679431|NCT01257230|3089097|Superiority or Other||Mean Difference (Final Values)|0.035|Standard Error of the Mean|0.059||0.5495|2-Sided|95.0|-0.08|0.15|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1679432|NCT01257230|3089097|Superiority or Other||Mean Difference (Final Values)|0.063|Standard Error of the Mean|0.06||0.2921|2-Sided|95.0|-0.055|0.181|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1679433|NCT01257230|3089098|Superiority or Other||Mean Difference (Final Values)|0.072|Standard Error of the Mean|0.056||0.195|2-Sided|95.0|-0.037|0.182|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1679434|NCT01257230|3089098|Superiority or Other||Mean Difference (Final Values)|0.088|Standard Error of the Mean|0.057||0.1231|2-Sided|95.0|-0.024|0.2|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1679435|NCT01257230|3089099|Superiority or Other||Mean Difference (Final Values)|0.117|Standard Error of the Mean|0.054||0.032|2-Sided|95.0|0.01|0.223|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1679436|NCT01257230|3089099|Superiority or Other||Mean Difference (Final Values)|0.084|Standard Error of the Mean|0.056||0.1307|2-Sided|95.0|-0.025|0.194|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1679437|NCT01257230|3089100|Superiority or Other||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.05||0.0005|2-Sided|95.0|0.076|0.272|||Mixed Models Analysis||Difference calculated as Tio R5 minus placebo||
1679438|NCT01257230|3089100|Superiority or Other||Mean Difference (Final Values)|0.134|Standard Error of the Mean|0.051||0.0085|2-Sided|95.0|0.034|0.234|||Mixed Models Analysis||Difference calculated as Tio R2.5 minus placebo||
1679439|NCT01257204|3089109|Superiority or Other||Difference|7.4|||||2-Sided|80.0|-9.4|24.2|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.||
1679440|NCT01257204|3089109|Superiority or Other||Difference|10.0|||||2-Sided|80.0|-6.8|26.7|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.||
1679441|NCT01257204|3089118|Superiority or Other||Difference|20.1|||||2-Sided|80.0|3.9|36.3|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.||
1679442|NCT01257204|3089118|Superiority or Other||Difference|20.8|||||2-Sided|80.0|4.9|36.8|||||The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.||
1679443|NCT01256944|3089120|Superiority or Other||||||<|0.05|||||||ANOVA||||
1679444|NCT01256944|3089121|Superiority or Other||||||<|0.05|||||||ANOVA||||
1679445|NCT01256944|3089123|Superiority or Other||||||<|0.05|||||||ANOVA||||
1679446|NCT01256944|3089124|Superiority or Other||||||<|0.05|||||||ANOVA||||
1679447|NCT01256944|3089125|Superiority or Other||||||<|0.05|||||||ANOVA||||
1679448|NCT01256944|3089126|Superiority or Other||||||<|0.05|||||||ANOVA||||
1679449|NCT01256944|3089128|Superiority or Other||||||<|0.05|||||||ANOVA||||
1679450|NCT01256944|3089129|Superiority or Other||||||<|0.05|||||||ANOVA||||
1679451|NCT01256944|3089130|Superiority or Other||||||<|0.05|||||||ANOVA||||
1679452|NCT01256918|3089131|Superiority or Other||pearson correlation coefficient|0.111166|||>|0.05|||||||pearson correlation coefficient|||null hypothesis there is no correlation between lens thickness and penetration of phacotip (phacodepth)required to achieve full thickness crack in vertical chop during phacoemulsification|
1679453|NCT01256918|3089132|Superiority or Other||pearson correlation coefficient|0.842617|||<|0.05|||||||pearson correlation coefficient|||"Null hypothesis:~there is no correlation between nuclear opalescence and phacodepth required to achieve full thickness nuclear crack using a callibrated phacotip."|
1679454|NCT01256918|3089133|Superiority or Other||pearson correlation coefficient|0.850958|||<|0.05|||||||pearson correlation coefficient|||null hypothesis : there is no correlation between nuclear colour and phacodepth required for a full thickness crack during a vertical chop|
1679455|NCT01256918|3089134|Superiority or Other||incidence|0.0|||>|0.05|||||||incidence|||"Any occurence of posterior capsular rupture in attempted vertical chop would have been an indicator of overzealous penetration as the vertical chop even though effective would not have been safe.~We hypothesised that use of callibrated phacotip after careful preoperative assessment for performing vertical chop during phacoemulsification is not associated with any posterior capsular rupture we noted any incidence of posterior capsular rupture."|
1679456|NCT01256879|3089136|Other|Each CimTest-A, CimTest-B, and Commercial Cimetidine Solution are compared to Active Comparator (i.e. Sorbitol-free Cimetidine Solution), as a percentage of Active Comparator, per routine FDA bioequivalence testing of AUC.|||||||||||||||||Bioequivalence testing of AUC, per FDA guidance, is applied. Each CimTest-A, CimTest-B, and Commercial Cimetidine Solution are compared to Active Comparator (i.e. Sorbitol-free Cimetidine Solution), as a percentage of Active Comparator, per routine FDA bioequivalence testing of AUC. The upper and lower 90% Confidence Interval for CimTest-A is 104.4% to 120.6%. The upper and lower 90% Confidence Interval for CimTest-B is 97.9% to 113.0%. The upper and lower 90% Confidence Interval for Commercial Cimetidine Solution is 93.2% to 107.7%.
1679457|NCT01256450|3089209|Superiority or Other||Mean Difference (Net)|-0.14||||0.587|2-Sided|95.0|-0.646|0.366|||ANCOVA||||
1679458|NCT01256385|3089228|Superiority or Other|||||||0.59|||||||Fisher Exact||||
1679459|NCT01256385|3089229|Superiority|||||||0.037||||||1-sided.|Chi-squared|||PFS at 4 months in Arm B was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).|
1679460|NCT01256385|3089229|Superiority|||||||0.006|||||||Chi-squared|||PFS at 4 months in Arm A was compared with a 4-month historical control rate of 21.4%, using a one-sided test at the 0.05 significant level. The historical data appear in two publications, an ASCO abstract: Abidoye, ASCO Annual Meeting 2006: 5568, and de Souza, Davis, et al, Clin Cancer Res 2012; 18(8):2336-2343 (see Figure 1).|
1679461|NCT01256385|3089230|Superiority or Other|||||||0.2|||||||Fisher Exact||||
1679464|NCT01256294|3089233|Superiority or Other||Ratio of geometric means|1.09||||0.057|2-Sided|90.0|1.01|1.18||ANOVA model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and subjects nested within sequences as a random factor.|ANOVA|||To compare the bioavailability of generic tacrolimus to branded tacrolimus, the 90% confidence intervals of the ratios of geometric means of Cmax were assessed relative to the interval [80%, 125%].|
1679465|NCT01256294|3089233|Superiority or Other||Ratio of geometric means|1.09|||||2-Sided|95.0|1.0|1.2|||||Ratio of geometric means: Generic tacrolimus/Branded tacrolimus||
1679466|NCT01256294|3089238|Superiority or Other||Ratio of geometric means|1.02||||0.486|2-Sided|90.0|0.97|1.08||ANOVA model for the dose-normalized log transformed values with treatment, period and sequence as fixed factors and subjects nested within sequences as a random factor.|ANOVA|||To compare the bioavailability of generic tacrolimus to branded tacrolimus, the 90% confidence intervals of the ratios of geometric means of AUC0-12h were assessed relative to the interval [80%, 125%].|
1679467|NCT01256294|3089238|Superiority or Other||Ratio of geometric means|1.02|||||2-Sided|95.0|0.96|1.09|||||||
1679468|NCT01256190|3089240|Superiority or Other|||||||0.025|||||||Fisher Exact|||intent-to-treat analysis|
1679469|NCT01256190|3089241|Superiority or Other|||||||0.113|||||||Fisher Exact|||intent-to treat analysis|
1679470|NCT01256190|3089242|Superiority or Other|||||||0.022|||||||Fisher Exact|||intent-to-treat analysis|
1679471|NCT01256190|3089243|Superiority or Other|||||||0.31|||||||t-test, 2 sided||||
1679472|NCT01256190|3089244|Superiority or Other|||||||0.004|||||||t-test, 2 sided||||
1679473|NCT01256177|3089245|Superiority or Other||Odds Ratio (OR)|0.26||||0.233|2-Sided|95.0|0.03|2.38|||Regression, Logistic|Odds ratio between treatment groups was modeled by logistic regression adjusted for centre, strata and baseline score.|Quetiapine XR/Placebo||
1679474|NCT01256177|3089246|Superiority or Other||Least Square Mean difference vs Placebo|-0.22|Standard Error of the Mean|0.08||0.005|2-Sided|95.0|-0.38|-0.07|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS item 10 score as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effect and centre as random.||Change from Baseline to Week 8 in MADRS item 10 score for suicidal ideation based on observed cases (OC)|
1679475|NCT01256177|3089247|Superiority or Other||Odds Ratio (OR)|2.06||||0.004|2-Sided|95.0|1.26|3.36|||Regression, Logistic|Odds ratio between treatment groups was modeled by logistic regression adjusted for centre, baseline score and bipolar Strata.|Quetiapine XR/Placebo||
1679476|NCT01256177|3089248|Superiority or Other||Least Square Mean difference vs Placebo|-0.47|Standard Error of the Mean|0.17||0.007|2-Sided|95.0|-0.81|-0.13|||Mixed Model Repeated Measures (MMRM)|Baseline CGI-BP-S score for depression as covariate, trt, Bipolar strata, visit, trt-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 assessment in the CGI-BP-S score of depression based on observed cases (OC)|
1679477|NCT01256177|3089248|Superiority or Other||Least Square Mean difference vs Placebo|-0.51|Standard Error of the Mean|0.17||0.003|2-Sided|95.0|-0.84|-0.17|||Mixed Model Repeated Measures (MMRM)|Baseline CGI-BP-S score for overall BP illness as covariate, trt, bipolar strata, visit, trt-visit interaction as fixed effect and centre as random.||Change from baseline to Week 8 assessment in the CGI-BP-S score for overall Bipolar (BP) illness based on observed cases (OC)|
1679478|NCT01256177|3089249|Superiority or Other||Least Square Mean difference vs Placebo|-2.24|Standard Error of the Mean|0.83||0.007|2-Sided|95.0|-3.88|-0.61|||Mixed Model Repeated Measures (MMRM)|Baseline HAM-D total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in HAM-D total score based on observed cases (OC)|
1679479|NCT01256177|3089250|Superiority or Other||Least Square Mean difference vs Placebo|-3.22|Standard Error of the Mean|1.1||0.004|2-Sided|95.0|-5.39|-1.04|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)|
1679480|NCT01256177|3089250|Superiority or Other||Least Square Mean difference vs Placebo|-2.08|Standard Error of the Mean|1.03||0.045|2-Sided|95.0|-4.12|-0.05|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 6 in MADRS total score based on observed cases (OC)|
1679481|NCT01256177|3089250|Superiority or Other||Least Square Mean difference vs Placebo|-3.12|Standard Error of the Mean|0.95||0.001|2-Sided|95.0|-5.0|-1.25|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 4 in MADRS total score based on observed cases (OC)|
1679482|NCT01256177|3089250|Superiority or Other||Least Square Mean difference vs Placebo|-2.43|Standard Error of the Mean|0.88||0.006|2-Sided|95.0|-4.16|-0.69|||Mixed Model Repeated Measure (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 2 in MADRS total score based on observed cases (OC)|
1679483|NCT01256177|3089250|Superiority or Other||Least Square Mean difference vs Placebo|-1.47|Standard Error of the Mean|0.67||0.029|2-Sided|95.0|-2.79|-0.15|||Mixed Model Repeated Measure (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 1 in MADRS total score based on observed cases (OC)|
1679484|NCT01256177|3089251|Superiority or Other||Odds Ratio (OR)|2.37||||0.001|2-Sided|95.0|1.46|3.86|||Regression, Logistic|Odds ratio was modeled by logistic regression adjusted for centre, baseline score, and bipolar strata.|Quetiapine XR/Placebo||
1679485|NCT01256177|3089252|Superiority or Other||Odds Ratio (OR)|2.54||||0.001|2-Sided|95.0|1.56|4.13|||Regression, Logistic|Odds ratio was modeled by logistic regression adjusted for centre, baseline score, and bipolar strata.|Quetiapine XR/Placebo||
1679486|NCT01256177|3089253|Superiority or Other||Least Square Mean difference vs Placebo|-3.22|Standard Error of the Mean|1.1||0.004|2-Sided|95.0|-5.39|-1.04|||Mixed Model Repeated Measures (MMRM)|Baseline MADRS total value as covariate, treatment, bipolar strata, visit, treatment-visit interaction as fixed effects and centre as random.||Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)|
1679488|NCT01256164|3089255|Superiority or Other|||||||0.001|||||||Fisher Exact|||intent-to- treat analysis|
1679489|NCT01256164|3089256|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Intent-to-treat analysis|
1679490|NCT01256164|3089257|Superiority or Other|||||||1|||||||t-test, 2 sided||||
1679491|NCT01256164|3089258|Non-Inferiority or Equivalence|With 90 subjects, randomized on a 2:1 ratio into the Fibrocaps plus gelatin sponge active arm or the gelatin sponge arm, and assuming a mean TTH of 3.5 minutes with a standard deviation of 2.5 minutes in the active arm and a mean TTH of 6 minutes in the control arm, this translates in a power of 99.4% at a two-sided significance level alpha of 5%, using a two-sample t-test.|||||<|0.001|||||||t-test, 2 sided||||
1679492|NCT01256086|3089259|Non-Inferiority or Equivalence|Relative potency of Novolizer compared to Aerolizer. Equivalence was to be concluded if the CI for the relative potency was completely covered by the interval (0.67, 1.50) according to OIP Guideline.|Relative potency|1.13|||||2-Sided|90.0|0.94|1.38|||||Fieller confidence interval for logarithm of relative potency||
1679493|NCT01256034|3089267|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1679494|NCT01255787|3089278|Superiority or Other||LS Mean Difference|-1.82|Standard Error of the Mean|1.11||0.2399|2-Sided|95.0|-4.436|0.794|||ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.|||
1679495|NCT01255787|3089278|Superiority or Other||LS Mean Difference|-1.69|Standard Error of the Mean|1.114||0.3006|2-Sided|95.0|-4.31|0.938|||ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.|||
1679496|NCT01255787|3089278|Superiority or Other||LS Mean Difference|-0.61|Standard Error of the Mean|1.123||0.907|2-Sided|95.0|-3.258|2.035||Adjustment for multiplicity for the comparisons was based on the Dunnett-Hsu procedure.|ANCOVA|Analysis of covariance (ANCOVA), with treatment as a fixed factors and baseline MADRS as a covariate.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance.|
1679497|NCT01255761|3089316|Non-Inferiority or Equivalence|If the lower bound of the 2-sided 95 % CI was greater than -15 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing percent of Week 12 responders achieving LDA at Week 52.|Difference in proportion|-0.013|||||2-Sided|95.0|-0.093|0.066||||||"The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -15 %.~A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed."|
1679498|NCT01255761|3089317|Non-Inferiority or Equivalence|If the lower bound of the 2-sided 95 % CI was greater than -10 %, the null hypothesis was rejected and RAPID3 was deemed comparable to CDAI in assessing response to Certolizumab Pegol therapy at 12 weeks.|Difference in proportion|-0.119|||||2-Sided|95.0|-0.184|-0.053||||||"The null hypothesis was: (Proportion of Rapid 3 responders)-(Proportion of CDAI responders) ≤ delta with a delta of -10 %.~A 2-sided 95 % Confidence Interval (CI) for the difference in proportion of responders was computed."|
1679499|NCT01255722|3089318|Superiority or Other|||||||0.09|||||||Fisher Exact||||
1679500|NCT01255722|3089319|Superiority or Other|||||||0.109|||||||Fisher Exact||||
1679501|NCT01255722|3089320|Superiority or Other|||||||0.001|||||||Fisher Exact||||
1679502|NCT01255722|3089322|Superiority or Other|||||||0.75|||||||Fisher Exact||||
1679503|NCT01255722|3089323|Non-Inferiority or Equivalence|The clinical non-inferiority margin was set to -10% maximum difference with the best comparator (i.e. iopromide).|Mean Difference (Final Values)|-0.033||||0.05|2-Sided|95.0|-0.088|0.021|||Chi-squared|||Iobitridol was compared to the best of the two comparators. The two-sided 95% confidence interval (CI) of the difference between both proportions (Iobitridol - Comparator) was computed and the lower limit of the CI compared to the clinical non-inferiority limit in the study. The non-inferiority of iobitridol over the best comparator was established if the lower limit of the two-sided 95% CI was equal to or higher than the clinical non-inferiority limit.|
1679504|NCT01255592|3089330|Superiority or Other||Ratio of LS means|6.07|||<|0.001|2-Sided|90.0|4.42|8.35|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679505|NCT01255592|3089331|Superiority or Other||Ratio of LS means|1.56||||0.001|2-Sided|90.0|1.28|1.91|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679506|NCT01255592|3089332|Superiority or Other||Ratio of LS means|1.16||||0.281|2-Sided|90.0|0.92|1.47|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679507|NCT01255592|3089333|Superiority or Other||Ratio of LS means|5.5|||<|0.001|2-Sided|90.0|4.18|7.23|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679508|NCT01255592|3089334|Superiority or Other||Ratio of LS means|1.05||||0.241|2-Sided|90.0|0.98|1.12|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679509|NCT01255592|3089335|Superiority or Other||Ratio of LS means|1.54||||0.112|2-Sided|90.0|0.98|2.4|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679510|NCT01255592|3089336|Superiority or Other||Ratio of LS means|1.33||||0.367|2-Sided|90.0|0.79|2.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679511|NCT01255592|3089337|Superiority or Other||Ratio of LS means|0.17||||0.111|2-Sided|90.0|0.03|1.08|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679512|NCT01255592|3089338|Superiority or Other||Ratio of LS means|1.02||||0.917|2-Sided|90.0|0.71|1.48|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679513|NCT01255592|3089339|Superiority or Other||Ratio of LS means|3.24|||<|0.001|2-Sided|90.0|2.19|4.79|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679514|NCT01255592|3089340|Superiority or Other||Ratio of LS means|1.43||||0.193|2-Sided|90.0|0.91|2.24|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679515|NCT01255592|3089341|Superiority or Other||Ratio of LS means|0.99||||0.968|2-Sided|90.0|0.78|1.27|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679516|NCT01255592|3089342|Superiority or Other||Ratio of LS means|0.92||||0.67|2-Sided|90.0|0.68|1.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679517|NCT01255592|3089343|Superiority or Other||Ratio of LS means|4.46|||<|0.001|2-Sided|90.0|3.05|6.54|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679518|NCT01255592|3089344|Superiority or Other||Ratio of LS means|0.69||||0.22|2-Sided|90.0|0.42|1.14|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679519|NCT01255592|3089345|Superiority or Other||LS mean difference|-0.39|Standard Error of the Mean|3.845||0.92|2-Sided|90.0|-6.84|6.07|||ANCOVA|||Impact domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679520|NCT01255592|3089345|Superiority or Other||LS mean difference|-1.31|Standard Error of the Mean|4.524||0.773|2-Sided|90.0|-8.91|6.28|||ANCOVA|||Activity domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679521|NCT01255592|3089345|Superiority or Other||LS mean difference|-4.88|Standard Error of the Mean|3.342||0.151|2-Sided|90.0|-10.49|0.74|||ANCOVA|||Symptom domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679522|NCT01255592|3089345|Superiority or Other||LS mean difference|-1.66|Standard Error of the Mean|3.374||0.625|2-Sided|90.0|-7.32|4.0|||ANCOVA|||Total score: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679523|NCT01255592|3089346|Superiority or Other||LS mean difference|0.0|Standard Error of the Mean|0.43||0.942|2-Sided|90.0|-0.75|0.68|||ANCOVA|||Number of puffs of inhalers: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679524|NCT01255592|3089346|Superiority or Other||LS mean difference|0.2|Standard Error of the Mean|0.14||0.179|2-Sided|90.0|-0.04|0.42|||ANCOVA|||How do you feel?: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679525|NCT01255592|3089346|Superiority or Other||LS mean difference|-0.2|Standard Error of the Mean|0.12||0.053|2-Sided|90.0|-0.45|-0.04|||ANCOVA|||Type of sputum: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679526|NCT01255592|3089346|Superiority or Other||LS mean difference|0.1|Standard Error of the Mean|0.12||0.248|2-Sided|90.0|-0.06|0.35|||ANCOVA|||The amount of sputum you produced: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679527|NCT01255592|3089346|Superiority or Other||LS mean difference|-0.4|Standard Error of the Mean|0.25||0.15|2-Sided|90.0|-0.8|0.05|||ANCOVA|||What color is your sputum?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679528|NCT01255592|3089346|Superiority or Other||LS mean difference|0.3|Standard Error of the Mean|0.17||0.152|2-Sided|90.0|-0.04|0.54|||ANCOVA|||Night time symptom score: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679529|NCT01255592|3089346|Superiority or Other||LS mean difference|0.1|Standard Error of the Mean|0.13||0.664|2-Sided|90.0|-0.16|0.27|||ANCOVA|||How often do you cough?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679530|NCT01255592|3089346|Superiority or Other||LS mean difference|0.1|Standard Error of the Mean|0.14||0.329|2-Sided|90.0|-0.09|0.36|||ANCOVA|||Describe your breathing: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679531|NCT01255592|3089347|Superiority or Other||LS mean difference|3.3|Standard Error of the Mean|7.35||0.654|2-Sided|90.0|-9.02|15.64|||ANCOVA|||Evening PEF: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679532|NCT01255592|3089347|Superiority or Other||LS mean difference|0.7|Standard Error of the Mean|8.03||0.935|2-Sided|90.0|-12.81|14.13|||ANCOVA|||Morning PEF: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679533|NCT01255592|3089348|Superiority or Other||LS mean difference|-1.0|Standard Error of the Mean|0.7||0.433|2-Sided|90.0|-1.6|0.6|||ANCOVA|||The ANCOVA model used TDI as the response variable with treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and BDI as covariates.|
1679534|NCT01255592|3089349|Superiority or Other||LS mean difference|0.02|Standard Error of the Mean|0.09||0.791|2-Sided|90.0|-0.13|0.17|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679535|NCT01255592|3089350|Superiority or Other||LS mean difference|0.0|Standard Error of the Mean|0.062||0.966|2-Sided|90.0|-0.11|0.1|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679536|NCT01255592|3089351|Superiority or Other||LS mean difference|0.01|Standard Error of the Mean|0.078||0.929|2-Sided|90.0|-0.12|0.14|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679537|NCT01255592|3089352|Superiority or Other||LS mean difference|0.1|Standard Error of the Mean|0.092||0.284|2-Sided|90.0|-0.05|0.26|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.|
1679538|NCT01255592|3089353|Superiority or Other||LS mean difference|6.78|Standard Error of the Mean|3.298||0.047|2-Sided|90.0|1.22|12.33|||ANCOVA|||The 24-hour sputum weight on Visit 4 was compared between groups using ANCOVA (additive model) with treatment and inhaled corticosteroids/P. aeruginosa infection as fixed effects and baseline as a covariate.|
1679993|NCT01245439|3090741|Superiority or Other||||||<|0.272|||||||Wilcoxon Signed Rank test.|||IN assessment Visit 6 to Visit 7|
1679539|NCT01255592|3089354|Superiority or Other||Ratio of AZD5069 80 mg to placebo|0.64||||0.008|2-Sided|90.0|0.49|0.84|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.|
1679540|NCT01255592|3089355|Superiority or Other||Ratio of AZD5069 80 mg to placebo|0.31||||0.004|2-Sided|90.0|0.17|0.59|||ANCOVA|||Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.|
1679541|NCT01255436|3089358|Superiority or Other||Risk Ratio (RR)|1.3||||0.014|2-Sided|95.0|1.04|1.53|||Fisher Exact||||
1679542|NCT01255436|3089359|Superiority or Other||Risk Ratio (RR)|1.3||||0.045|2-Sided|95.0|1.0|1.6|||Fisher Exact||Numerator is Treatment Group (SMS reminders) and Denominator is Control Group (No SMS reminders)||
1679543|NCT01255436|3089360|Superiority or Other||Mean Difference (Final Values)|-1.5||||0.14|2-Sided|95.0|-4.1|1.3||p-value < 0.05 considered significant|t-test, 1 sided||||
1679544|NCT01255436|3089361|Superiority or Other||Mean Difference (Final Values)|-4.2||||0.06|2-Sided|95.0|-9.4|1.0||p-value<0.05 is considered significant|t-test, 1 sided||||
1679545|NCT01255163|3089369|Other|||||||0.009||||||Type III Tests of Fixed Effects: Group * VisitLong F (8, 72.603) = 2.816, p = 0.009. Univarate Exendin-4 F(4, 72.944) = 4.834, p = 0.002. Pairwise comparisons for Exendin-4 showed a decrease in BMI baseline vs. 6 months (p = 0.029).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED BMI BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group*VisitLong | SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong | SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."
1679546|NCT01255163|3089370|Other|||||||0.018||||||Type III Tests of Fixed Effects: Group * VisitLong F (2, 16.614) = 5.142, p = 0.018. Univariate tests: Placebo F(1, 16.595) = 4.138, p = 0.058; Exendin-4 F(1, 16.595) = 6.262, p = 0.022. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.022).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED Ab42 BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group*VisitLong | SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong | SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."
1679547|NCT01255163|3089371|Other|||||||0.845||||||Threshold for statistical significance p < 0.05. Type III Tests of Fixed Effects Group * VisitLong F (2, 15.828) = 0.170, p = 0.845.|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED pTAU BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group*VisitLong | SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong | SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."
1679548|NCT01255163|3089372|Other|||||||0.703||||||Threshold for statistical significance p < 0.05. Type III Tests of Fixed Effects Group * VisitLong F (2, 15.251) = 0.360, p = 0.703.|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline,18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED TAU BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group*VisitLong | SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong | SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."
1679549|NCT01255163|3089373|Other|||||||0.031||||||Threshold for statistical significance p < 0.05. Type III Tests of Fixed Effects: Group * VisitLong F (6, 51.955) = 2.553, p = 0.031. Univarate Exendin-4 F(3, 51.386) = 2.734, p = 0.053. Pairwise for Exendin-4, baseline vs. 18 months (p = 0.035).|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED CDR.sob BY Group Sex VisitLong WITH Age CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group*VisitLong | SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong | SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."
1679550|NCT01255163|3089374|Other|||||||0.141||||||Threshold for statistical significance p < 0.05. Type III Tests of Fixed Effects Group * VisitLong F (6, 47.485) = 1.704, p = 0.141|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED CDR BY Group Sex VisitLong WITH Age~CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE) FIXED=Group Sex Age Group*VisitLong | SSTYPE(3) METHOD=REML PRINT=SOLUTION REPEATED=VisitLong | SUBJECT(SubjectID) COVTYPE(AR1) EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI) EMMEANS=TABLES(Group*VisitLong) COMPARE(Group) ADJ(BONFERRONI) EMMEANS=TABLES(Group*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."
1679618|NCT01253135|3089725|Superiority or Other|||||||0.4771|||||||Log Rank|Testing was by a Log Rank test with significance being at P < 0.05|||
1679619|NCT01253135|3089726|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Deviation|4.7||0.3393|2-Sided|95.0|-3.08|0.84|||Prentice-Wilcoxon test||The Confidence Interval was based on a t-distribution||
1679551|NCT01255163|3089375|Other|||||||0.295||||||"Threshold for statistical significance p < 0.05.~Type III Tests of Fixed Effects for Group*VisitLong F (6, 52.281) = 1.254, p = 0.295"|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED ADAS70 BY Group Sex VisitLong WITH Age~CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE)~FIXED=Group Sex Age Group*VisitLong | SSTYPE(3)~METHOD=REML~PRINT=SOLUTION~REPEATED=VisitLong | SUBJECT(SubjectID) COVTYPE(AR1)~EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI)~EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI)~EMMEANS=TABLES(Group*VisitLong) COMPARE(Group) ADJ(BONFERRONI)~EMMEANS=TABLES(Group*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."
1679552|NCT01255163|3089376|Other|||||||0.098||||||"Threshold for statistical significance p < 0.05.~Type III Tests of Fixed Effects Group * VisitLong F (6, 52.008) = 1.902, p = 0.098"|Mixed Models Analysis|Repeated measures mixed model with Repeated Factor (Visit Long: baseline, 6, 12, 18 months), Fixed Factors (Group,VisitLong, Sex) and Covariate (Age)|||"MIXED MMSE.tot BY Group Sex VisitLong WITH Age~CRITERIA=CIN(95) MXITER(100) MXSTEP(10) SCORING(1) SINGULAR(0.000000000001) HCONVERGE(0, ABSOLUTE) LCONVERGE(0, ABSOLUTE) PCONVERGE(0.000001, ABSOLUTE)~FIXED=Group Sex Age Group*VisitLong | SSTYPE(3)~METHOD=REML~PRINT=SOLUTION~REPEATED=VisitLong | SUBJECT(SubjectID) COVTYPE(AR1)~EMMEANS=TABLES(Group) COMPARE ADJ(BONFERRONI)~EMMEANS=TABLES(Sex) COMPARE ADJ(BONFERRONI)~EMMEANS=TABLES(Group*VisitLong) COMPARE(Group) ADJ(BONFERRONI)~EMMEANS=TABLES(Group*VisitLong) COMPARE(VisitLong) ADJ(BONFERRONI) ."
1679553|NCT01255163|3089377|Other|||||||0.016||||||threshold for significance (p < 0.05)|Fisher Exact||||
1679554|NCT01254851|3089388|Superiority or Other||Standardized test statistic (z-score)|0.39||||0.7|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1679555|NCT01254630|3089418|Other||Risk Difference (RD)|0.5|||||2-Sided|95.0|-0.6|1.6|||||||
1679556|NCT01254630|3089419|Other||Vaccine Efficacy|0.746|||||2-Sided|95.0|-1.275|0.972|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be >0.25.|
1679557|NCT01254630|3089420|Other||Vaccine Efficacy|0.874|||||2-Sided|95.0|-0.005|0.984|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be >0.25.|
1679558|NCT01254630|3089421|Other||Vaccine Efficacy|0.771|||||2-Sided|95.0|0.48|0.899|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI be >0.25.|
1679559|NCT01254630|3089422|Other||Risk Difference (RD)|1.4|||||2-Sided|95.0|-1.8|4.5|||||||
1679560|NCT01254630|3089423|Superiority||Vaccine Efficacy|0.636|||||2-Sided|97.5|0.364|0.791|||||Point estimate and 97.5% CI of vaccine efficacy (primary endpoint) were obtained from a Cox proportional hazards regression model, adjusting for age (<50 versus ≥50 years of age).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 97.5% Confidence Interval (CI) be >0.25.|
1679561|NCT01254604|3089424|Superiority or Other||Difference in percentage|1.1|||||2-Sided|95.0|-3.5|5.7|||||Between-group difference in percentage of participants discontinued study drug due to an AE = percentage (tafluprost) − percentage (timolol)||
1679562|NCT01254604|3089425|Superiority or Other||Difference in percentage|-3.9|||||2-Sided|95.0|-17.3|9.4|||||Between-group difference in percentage of participants with an AE = percentage (tafluprost) − percentage (timolol)||
1679563|NCT01254604|3089426|Superiority or Other||Difference in percentage|19.5|||||2-Sided|95.0|5.7|33.4|||||Between-group difference in percentage of participants with ≥25% reduction in IOP at Week 4 = percentage (tafluprost) − percentage (timolol)||
1679564|NCT01254604|3089427|Non-Inferiority or Equivalence|The study was planned to enroll 248 subjects (124 per treatment group) to yield approximately 230 evaluable subjects (115 per treatment group). The study had power of 90% to test the primary hypothesis. The power and sample size were based on the following assumptions for treatment difference in change from baseline in IOP at Week 4: α = 0.025 (1-sided), Non-inferiority margin = 1.5 mmHg, True treatment difference = 0 mmHg, Standard deviation = 3.5 mmHg.|Difference in Least Squares Means|-1.7|||||2-Sided|95.0|-2.6|-0.7|||||Difference is tafluprost − timolol|The study hypothesis was that tafluprost is non-inferior to timolol with respect to change from baseline in diurnal IOP at Week 4 in participants with open-angle glaucoma or ocular hypertension. The study hypothesis would be met if the upper bound of the two-sided 95% confidence interval for the between-treatment difference in mean diurnal IOP change from baseline at Week4 (tafluprost − timolol) was ≤1.5 mmHg.|
1679565|NCT01254565|3089429|Superiority||LS Mean Difference|-27.7||||0.0554|2-Sided|95.0|-39.3|-1.6|||ANOVA|A rank ANOVA model with treatment and screening PTH (< 600 or ≥ 600 pg/mL) as factors.|||
1679566|NCT01254565|3089429|Superiority||LS Mean Difference|-11.2||||0.0112|2-Sided|95.0|-26.8|-4.9|||ANOVA|A rank ANOVA model with treatment and screening PTH (< 600 or ≥ 600 pg/mL) as factors.|||
1679567|NCT01254565|3089430|Superiority||LS mean Difference|-21.8||||0.1751|2-Sided|95.0|-29.8|5.9|||ANOVA|A rank ANOVA model with treatment and screening PTH (< 600 or ≥ 600 pg/mL) as factors.|||
1679568|NCT01254565|3089430|Superiority||LS Mean Difference|-4.2||||0.2255|2-Sided|95.0|-18.6|5.7|||ANOVA|A rank ANOVA model with treatment and screening PTH (< 600 or ≥ 600 pg/mL) as factors.|||
1679569|NCT01254565|3089431|Superiority||LS Mean Difference|-6.9||||0.0235|2-Sided|95.0|-12.8|-1.0|||ANOVA|ANOVA model with treatment and screening PTH (< 600 or ≥ 600 pg/mL) as factors.|||
1679570|NCT01254565|3089431|Superiority||LS Mean Difference|-11.3|||<|0.0001|2-Sided|95.0|-16.4|-8.4|||ANOVA|A rank ANOVA model with treatment and screening PTH (< 600 or ≥ 600 pg/mL) as factors.|||
1679571|NCT01254565|3089432|Superiority|||||||0.073|||||||Fisher Exact||||
1679572|NCT01254565|3089432|Superiority||||||<|0.0001|||||||Fisher Exact||||
1679573|NCT01254565|3089433|Superiority|||||||0.0968|||||||Fisher Exact||||
1679575|NCT01254565|3089434|Superiority|The primary endpoint was tested at the 0.05 level (1-sided).|LS Mean Difference|-36.7||||0.0032|2-Sided|95.0|-59.8|-13.6|||ANOVA|ANOVA model with treatment and screening PTH (< 600 pg/mL or ≥ 600 pg/mL) as factors.||The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.|
1679576|NCT01254565|3089434|Superiority|The primary endpoint was tested at the 0.05 level (1-sided).|LS Mean Difference|-76.9|||<|0.0001|2-Sided|95.0|-86.9|-50.0|||ANOVA|A rank analysis of variance (ANOVA) model with treatment and screening PTH (< 600 pg/mL or ≥ 600 pg/mL) as factors.||The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.|
1679577|NCT01254552|3089436|Other||rate|0.071|||||2-Sided|95.0|0.043|0.1|||||||
1679578|NCT01254396|3089461|Superiority or Other||Ratio of Adjusted Means|87.66|||||2-Sided|90.0|77.62|98.99||||||Natural log transformed AUClast of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.|
1679579|NCT01254396|3089462|Superiority or Other||Ratio of Adjusted Means|93.42|||||2-Sided|90.0|80.23|108.78||||||Natural log transformed AUC (0-∞) of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.|
1679580|NCT01254396|3089464|Superiority or Other||Ratio of Adjusted Means|41.35|||||2-Sided|90.0|32.4|52.76||||||Natural log transformed Cmax of sildenafil was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios.|
1679581|NCT01254344|3089465|Superiority or Other||Difference in percentage of prophylaxis|1.3|||||2-Sided|95.0|-2.2|5.1|||||||
1679582|NCT01254344|3089466|Non-Inferiority or Equivalence|"Assuming a 70% rate (i.e., proportion of participants with success of prophylaxis) for both groups and a significance level of 0.025, at least 200 evaluable participants per group were needed to have 90% probability that the lower limit of the 95% (two-sided) confidence interval for the difference in the response rates between the 2 groups was greater than -15 percentage points."|Difference in percentage of prophylaxis|0.1|||||2-Sided|95.0|-5.2|5.5|||||||
1679583|NCT01254292|3089518|Superiority or Other||single proportion|81.9|||||2-Sided|95.0|76.7|86.4|||||Clopper Pearson Confidence Interval||
1679584|NCT01254292|3089518|Superiority or Other||single proportion|82.1|||||2-Sided|95.0|77.1|86.5|||||Clopper Pearson Confidence Interval||
1679585|NCT01254019|3089542|Superiority||Mean Difference (Net)|0.0048||||0.88|2-Sided|95.0|-0.058|0.0676||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo, HUI3 at Week 48|
1679586|NCT01254019|3089542|Superiority||Mean Difference (Net)|0.0288||||0.207|2-Sided|95.0|-0.0161|0.0738||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo, HUI2 at Week 48|
1679587|NCT01254019|3089548|Superiority||Mean Difference (Net)|-4044.99||||0|2-Sided|95.0|-5232.21|-2857.77||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo|
1679588|NCT01254019|3089551|Superiority||Mean Difference (Net)|-0.965||||0.769|2-Sided|95.0|-7.446|5.516||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo|
1679589|NCT01254019|3089552|Superiority||Mean Difference (Net)|0.041||||0.513|2-Sided|95.0|-0.082|0.164||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo|
1679590|NCT01254019|3089553|Superiority||Mean Difference (Net)|-1.115||||0.658|2-Sided|95.0|-6.097|3.866||No adjustment for multiplicity was made, so p-values should not be used to make conclusions with regards to statistical significance.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo|
1679591|NCT01254019|3089554|Superiority||Mean Difference (Net)|-0.009||||0.881|2-Sided|95.0|-0.129|0.111||SS was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo|
1679620|NCT01253044|3089730|Superiority or Other|||||||0.273|||||||MMRM||||
1679621|NCT01253044|3089731|Superiority or Other|||||||0.912|||||||MMRM||||
1679994|NCT01245439|3090741|Superiority or Other||||||<|0.084|||||||Wilcoxon Signed Rank test.|||IN assessment Visit 5 to Visit 6|
1679592|NCT01254019|3089555|Superiority||Mean Difference (Net)|-0.021||||0.718|2-Sided|95.0|-0.137|0.095||SS was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo|
1679593|NCT01254019|3089556|Superiority||Mean Difference (Net)|-0.53||||0.757|2-Sided|95.0|-3.95|2.88||Statistical significance (SS) was only to be assessed if a statistically significant difference was observed for the primary and any secondary endpoints higher in the pre-defined hierarchy. Hence conclusions with regards to SS should not be made.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo|
1679594|NCT01254019|3089557|Superiority||Mean Difference (Net)|10.334||||0.415|2-Sided|95.0|-14.645|35.312||Statistical significance was assessed at the 5% level.|Mixed Effect Model for Repeated Measures|Model included terms for treatment, visit, treatment by visit, country grouping, Baseline and Baseline by visit.||GSK2402968 6mg/kg/week Vs Placebo|
1679595|NCT01253980|3089558|Superiority or Other||Relative risk|0.6|||>|0.5|2-Sided|95.0|0.11|3.37|||Fisher Exact||||
1679596|NCT01253577|3089591|Superiority or Other|||||||0.0023|||||||McNemar||||
1679597|NCT01253577|3089592|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1679598|NCT01253577|3089593|Superiority or Other|||||||0.028|||||||McNemar||||
1679599|NCT01253200|3089697|Non-Inferiority or Equivalence|The Primary Safety Endpoint was evaluated using a one-sided, non-inferiority test for two binomial proportions at an alpha-level of 0.05. A 95% confidence interval based upon a score test of the difference of proportion of subjects in the Investigational and Control Groups free from a procedure-related complication seven days post-procedure was constructed. The upper bound of the confidence interval was compared to 10%.|Risk Difference (RD)|4.6|||||1-Sided|95.0||9.78||||||Note that analysis of the primary outcome was conducted for Randomized subjects only as prespecified in the study protocol. This is consistent analysis publicly available in the Summary of Safety and Effectiveness Data (SSED).|
1679600|NCT01253187|3089700|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.3||||||90.0|97.65|103.02|||||Point estimate for the ratio [(EE20/DRSP/L-5-MTHF Ca) / YAZ]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|32 volunteers qualified for statistical analysis of BE whereas all 34 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679601|NCT01253187|3089702|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.88||||||90.0|95.38|104.58|||||Point estimate for the ratio [(EE20/DRSP/L-5-MTHF Ca) / Metafolin]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|40 volunteers qualified for statistical analysis of BE and all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679602|NCT01253187|3089703|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.28||||||90.0|93.15|107.95|||||Point estimate for the ratio [(EE20/DRSP/L-5-MTHF Ca) / Metafolin]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|40 volunteers qualified for statistical analysis of BE and all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679603|NCT01253187|3089704|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|98.16||||||90.0|93.95|102.57|||||Point estimate for the ratio [(EE20/DRSP/L-5-MTHF Ca) / Metafolin]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 39 (EE20/DRSP/L-5-MTHF Ca) and 40 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679604|NCT01253187|3089705|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.88||||||90.0|91.24|109.34|||||Point estimate for the ratio [(EE20/DRSP/L-5-MTHF Ca) / Metafolin]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 39 (EE20/DRSP/L-5-MTHF Ca) and 40 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679605|NCT01253187|3089706|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|100.48||||||90.0|97.28|103.79|||||Point estimate for the ratio [(EE20/DRSP/L-5-MTHF Ca) / YAZ]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|33 volunteers qualified for statistical analysis of BE whereas all 35 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679606|NCT01253187|3089707|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|105.24||||||90.0|97.3|113.83|||||Point estimate for the ratio [(EE20/DRSP/L-5-MTHF Ca) / YAZ]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|33 volunteers qualified for statistical analysis of BE whereas all 35 (YAZ) and 36 (EE20/DRSP/L-5-MTHF Ca) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679607|NCT01253187|3089708|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|103.47||||||90.0|99.16|107.98|||||Point estimate for the ratio [(EE20/DRSP/L-5-MTHF Ca) / YAZ]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 39 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679608|NCT01253187|3089709|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|106.03||||||90.0|98.86|113.72|||||Point estimate for the ratio [(EE20/DRSP/L-5-MTHF Ca) / YAZ]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 39 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679609|NCT01253174|3089712|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.57||||||90.0|97.32|101.87|||||Point estimate for the ratio [(EE30/DRSP/L-5-MTHF Ca) / Yasmin]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|38 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679610|NCT01253174|3089714|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.63||||||90.0|95.73|103.69|||||Point estimate for the ratio [(EE30/DRSP/L-5-MTHF Ca) / Metafolin]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679611|NCT01253174|3089715|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|104.9||||||90.0|98.83|111.34|||||Point estimate for the ratio [(EE30/DRSP/L-5-MTHF Ca) / Metafolin]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679612|NCT01253174|3089716|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|97.98||||||90.0|94.19|101.93|||||Point estimate for the ratio [(EE30/DRSP/L-5-MTHF Ca) / Metafolin]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679613|NCT01253174|3089717|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|106.19||||||90.0|99.18|113.68|||||Point estimate for the ratio [(EE30/DRSP/L-5-MTHF Ca) / Metafolin]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 41 (EE30/DRSP/L-5-MTHF Ca) and 43 (Metafolin) volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679614|NCT01253174|3089718|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|99.45||||||90.0|96.7|102.28|||||Point estimate for the ratio [(EE30/DRSP/L-5-MTHF Ca) / Yasmin]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679615|NCT01253174|3089719|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|98.66||||||90.0|93.37|104.24|||||Point estimate for the ratio [(EE30/DRSP/L-5-MTHF Ca) / Yasmin]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|39 volunteers qualified for statistical analysis of BE whereas all 40 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679616|NCT01253174|3089720|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|101.13||||||90.0|97.65|104.75|||||Point estimate for the ratio [(EE30/DRSP/L-5-MTHF Ca) / Yasmin]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 42 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679617|NCT01253174|3089721|Non-Inferiority or Equivalence|A sample size of 6 volunteers per sequence was considered sufficient to establish bioequivalence, id est the 90%-confidence interval for the mean ratio is located completely within the equivalence interval limits of 80% and 125%.|mean ratio|102.26||||||90.0|96.65|108.2|||||Point estimate for the ratio [(EE30/DRSP/L-5-MTHF Ca) / Yasmin]. Bioequivalence is established if the 90% confidence interval fall within the equivalence interval limits of 80-125%|41 volunteers qualified for statistical analysis of BE whereas all 42 volunteers with valid concentration time profiles were included in the pharmacokinetic (PK) analysis|
1679622|NCT01253018|3089732|Superiority or Other (legacy)||||||<|0.05|||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in SIS Hand between the two interventions groups at retention week 24.|
1679623|NCT01253018|3089732|Superiority or Other (legacy)||||||<|0.05|||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in SIS Hand between the two interventions groups at final training week 12.|
1679624|NCT01253018|3089733|Superiority or Other (legacy)||||||<|0.05|||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in WMFT between the two interventions groups at retention 24 weeks.|
1679625|NCT01253018|3089733|Superiority or Other (legacy)||||||<|0.05|||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in WMFT between the two interventions groups at final training 12 week.|
1679626|NCT01253018|3089735|Superiority or Other (legacy)||||||<|0.05|||||||t-test, 2 sided|||Two sample t-tests were conducted to compare changes in FM between the two interventions groups at retention (24 weeks).|
1679627|NCT01253018|3089735|Superiority or Other (legacy)||||||<|0.05|||||||t-test, 2 sided|||"Sample size and power calculations were performed based on the difference in the FM score between the two groups with an assumed within group SD of 15.9, the correlation of 0.5 among repeated measures. 30 subjects enrolled in each arm of the study would give 80% power for detecting a difference of 8 points on the FM.~Two sample t-tests were conducted to compare changes in FM between the two interventions groups at final training (12 week)."|
1679628|NCT01252966|3089736|Superiority or Other|||||||0.033||||||Results would not survive correction for multiple hypothesis testing.|Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.|
1679629|NCT01252966|3089737|Superiority or Other|||||||0.3|||||||Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.|
1679630|NCT01252966|3089738|Superiority or Other|||||||0.3|||||||Regression, Linear|||Multiple regression models were used to estimate effects of treatment on change in cognitive performance. Age, Shipley IQ score, number of cigarettes smoked per day at baseline, and EOT smoking status were included as covariates.|
1679631|NCT01252966|3089740|Superiority or Other||Odds Ratio (OR)|0.69||||0.14|2-Sided|95.0|0.42|1.13|||Regression, Logistic|||Longitudinal logistic regression with fitted generalized estimating equations (GEE) was used to estimate an overall treatment effect odds ratio including both the EOT and 6-month time points and relevant covariates (e.g., baseline smoking rate, age, Shipley IQ score). The study (n=213) had 80% power to detect small to medium effects on quit rates (corresponding to Cohen’s one-sample d=0.38).|
1679632|NCT01252953|3089741|Other|Time to first event|Rate Ratio|0.93||||0.02|2-Sided|95.0|0.88|0.99|||Log Rank||||
1679633|NCT01252953|3089742|Other|Time to first event|Rate Ratio|0.99|||||2-Sided|95.0|0.87|1.12|||||||
1679634|NCT01252953|3089743|Other|Time to first event|Rate Ratio|0.93||||0.052|2-Sided|95.0|0.86|1.0|||Log Rank||||
1679635|NCT01252953|3089744|Other|Time to first event|Rate Ratio|0.91||||0.004|2-Sided|95.0|0.85|0.97|||Log Rank||||
1679636|NCT01252940|3089756|Non-Inferiority or Equivalence|A 95% confidence interval (CI) for the difference between treatment groups in the percentages of virologic success was constructed using normal approximation. Noninferiority was assessed using a conventional 95% CI approach, with a noninferiority margin of 12%. It would be concluded that the FTC/RPV/TDF STR group was not inferior to the SBR group if the lower bound of the 2-sided 95% CI of the difference (FTC/RPV/TDF STR – SBR) in the response rate was greater than -12%.|Mean Difference (Net)|3.8|||||2-Sided|95.0|-1.6|9.1|||||||
1679637|NCT01252563|3089772|Superiority or Other||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.|
1679638|NCT01252563|3089772|Superiority or Other||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.|
1679639|NCT01252563|3089772|Superiority or Other||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.|
1679640|NCT01252563|3089772|Superiority or Other||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean changes in home DBP from the baseline are equal to 0.|
1679641|NCT01252563|3089773|Superiority or Other||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.|
1679642|NCT01252563|3089773|Superiority or Other||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.|
1679643|NCT01252563|3089773|Superiority or Other||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.|
1679644|NCT01252563|3089773|Superiority or Other||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in home SBP from the baseline was equal to 0.|
1679645|NCT01252563|3089775|Superiority or Other||||||<|0.001|||||||Chi-squared|||The risk factor tested was “ambulatory SBP at baseline”. The null hypothesis was that there was no association between ambulatory SBP at baseline and the number of participants who achieved the target blood pressure specified in the guidelines.|
1679646|NCT01252563|3089776|Superiority or Other||||||<|0.001|||||||Chi-squared|||The risk factor tested was “metabolic syndrome” as a complication. The null hypothesis was that there was no difference between participants with metabolic syndrome and participants without metabolic syndrome in the efficacy.|
1679647|NCT01252563|3089777|Superiority or Other|||||||0.039|||||||Chi-squared|||The risk factor tested was “myocardial infarction” as a complication. The null hypothesis was that there was no difference between participants with myocardial infarction and participants without myocardial infarction in the efficacy.|
1679648|NCT01252563|3089778|Superiority or Other||||||<|0.001|||||||Chi-squared|||The risk factor tested was “chronic kidney disease” as a complication. The null hypothesis was that there was no difference between participants with chronic kidney disease and participants without chronic kidney disease in the efficacy.|
1679649|NCT01252563|3089779|Superiority or Other||||||<|0.001|||||||Chi-squared|||The risk factor tested was “diabetes mellitus” as a complication. The null hypothesis was that there was no difference between participants with diabetes mellitus and participants without diabetes mellitus in the efficacy.|
1679650|NCT01252563|3089780|Superiority or Other|||||||0.043|||||||Chi-squared|||The risk factor tested was “ARB” as a concomitant drug. The null hypothesis was that there was no difference between participants receiving ARB and participants receiving no ARB in the frequency of treatment-related adverse events.|
1679651|NCT01252563|3089781|Superiority or Other|||||||0.049|||||||Chi-squared|||The risk factor tested was “antihypertensive” as a concomitant drug. The null hypothesis was that there was no difference between participants receiving antihypertensive and participants receiving no antihypertensive in the frequency of treatment-related adverse events.|
1679652|NCT01252563|3089782|Superiority or Other|||||||0.02|||||||Chi-squared|||The risk factor tested was “dyslipidaemia” as a complication. The null hypothesis was that there was no difference between participants with dyslipidaemia and participants without dyslipidaemia in the frequency of treatment-related adverse events.|
1679653|NCT01252563|3089783|Superiority or Other|||||||0.036|||||||Chi-squared|||The risk factor tested was “angina pectoris” as a complication. The null hypothesis was that there was no difference between participants with angina pectoris and participants without angina pectoris in the frequency of treatment-related adverse events.|
1679654|NCT01252563|3089784|Superiority or Other||||||<|0.001|||||||Chi-squared|||The risk factor tested was “Gender”. The null hypothesis was that there was no difference between male and female in the frequency of treatment-related adverse events.|
1679655|NCT01252563|3089785|Superiority or Other||||||<|0.001|||||||Chi-squared|||The risk factor tested was “Complication”. The null hypothesis was that there was no difference between participants with complication(s) and participants without complication in the frequency of treatment-related adverse events.|
1679656|NCT01252563|3089788|Superiority or Other||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.|
1679657|NCT01252563|3089788|Superiority or Other||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.|
1679658|NCT01252563|3089788|Superiority or Other||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.|
1679659|NCT01252563|3089788|Superiority or Other||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory DBP from the baseline was equal to 0.|
1679660|NCT01252563|3089789|Superiority or Other||||||<|0.001||||||Last Day|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.|
1679661|NCT01252563|3089789|Superiority or Other||||||<|0.001||||||Week 12|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.|
1679662|NCT01252563|3089789|Superiority or Other||||||<|0.001||||||Week 8|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.|
1679663|NCT01252563|3089789|Superiority or Other||||||<|0.001||||||Week 4|t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis was that the mean change in ambulatory SBP from the baseline was equal to 0.|
1679664|NCT01252277|3089808|Superiority or Other|||||||0.48||||||No adjustment for multiple comparisons. A priori threshold for statistical significance, p<0.05|Wilcoxon (Mann-Whitney)||||
1679665|NCT01252277|3089809|Superiority or Other||||||<|0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance p<0.05|Wilcoxon (Mann-Whitney)||||
1679666|NCT01252277|3089810|Superiority or Other|||||||0.021||||||No adjustment for multiple comparisons|Wilcoxon (Mann-Whitney)||||
1679667|NCT01252277|3089811|Superiority or Other||||||<|0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance, p<0.05.|Wilcoxon (Mann-Whitney)||||
1679668|NCT01252186|3089822|Superiority or Other||Treatment Difference|130.15|||<|0.001|2-Sided|95.0|106.2|154.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679669|NCT01252186|3089822|Superiority or Other||Treatment Difference|-4.01|||<|0.731|2-Sided|95.0|-27.0|19.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679670|NCT01252186|3089823|Superiority or Other||Treatment Difference|58.3||||0.376|2-Sided|95.0|-71.3|187.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679671|NCT01252186|3089823|Superiority or Other||Treatment Difference|-12.49||||0.843|2-Sided|95.0|-136.4|111.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679783|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|1.24||||0.5216|2-Sided|95.0|0.64|2.39|||Log Rank|||Subgroup analysis: ≥ 70 years of age|
1679672|NCT01252186|3089824|Superiority or Other||Treatment Difference|9.74||||0.781|2-Sided|95.0|-59.4|78.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679673|NCT01252186|3089824|Superiority or Other||Treatment Difference|44.46||||0.19|2-Sided|95.0|-22.3|111.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679674|NCT01252186|3089825|Superiority or Other||Treatment Difference|0.44||||0.021|2-Sided|95.0|0.1|0.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679675|NCT01252186|3089825|Superiority or Other||Treatment Difference|0.33||||0.076|2-Sided|95.0|0.0|0.7|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679676|NCT01252186|3089826|Superiority or Other||Treatment Difference|-5.99||||0.001|2-Sided|95.0|-9.6|-2.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679677|NCT01252186|3089826|Superiority or Other||Treatment Difference|-2.11||||0.227|2-Sided|95.0|-5.6|1.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679678|NCT01252186|3089827|Superiority or Other||Treatment Difference|-10.53|||<|0.001|2-Sided|95.0|-14.8|-6.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679679|NCT01252186|3089827|Superiority or Other||Treatment Difference|-0.42|||<|0.841|2-Sided|95.0|-4.6|3.7|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679680|NCT01252186|3089828|Superiority or Other||Treatment Difference|-20.98|||<|0.001|2-Sided|95.0|-27.0|-15.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679681|NCT01252186|3089828|Superiority or Other||Treatment Difference|1.66|||<|0.572|2-Sided|95.0|-4.1|7.5|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679682|NCT01252186|3089829|Superiority or Other||Treatment Difference|-2.83||||0.384|2-Sided|95.0|-9.2|3.6|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679683|NCT01252186|3089829|Superiority or Other||Treatment Difference|-0.86||||0.783|2-Sided|595.0|-7.0|5.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679684|NCT01252186|3089830|Superiority or Other||Treatment Difference|3.73||||0.323|2-Sided|95.0|-3.7|11.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679685|NCT01252186|3089830|Superiority or Other||Treatment Difference|1.75||||0.631|2-Sided|95.0|-5.4|8.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679686|NCT01252186|3089831|Superiority or Other||Treatment Difference|-3.19||||0.028|2-Sided|95.0|-6.0|-0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679687|NCT01252186|3089831|Superiority or Other||Treatment Difference|-2.4||||0.088|2-Sided|95.0|-5.2|0.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679784|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.73||||0.0021|2-Sided|95.0|0.59|0.89|||Log Rank|||Subgroup analysis: < 70 years of age|
1679995|NCT01245439|3090741|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||IN assessment Visit 4 to Visit 5|
1679688|NCT01252186|3089832|Superiority or Other||Treatment Difference|8.76||||0.041|2-Sided|95.0|0.3|17.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679689|NCT01252186|3089832|Superiority or Other||Treatment Difference|3.3||||0.425|2-Sided|195.0|-4.9|11.5|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679690|NCT01252186|3089833|Superiority or Other||Treatment Difference|28.95||||0.008|2-Sided|95.0|7.7|50.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679691|NCT01252186|3089833|Superiority or Other||Treatment Difference|8.71||||0.405|2-Sided|95.0|-11.9|29.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679692|NCT01252186|3089834|Superiority or Other||Treatment Difference|1.68||||0.496|2-Sided|95.0|-3.2|6.6|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679693|NCT01252186|3089834|Superiority or Other||Treatment Difference|1.09||||0.648|2-Sided|95.0|-3.6|5.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679694|NCT01252186|3089835|Superiority or Other||Treatment Difference|-0.02||||0.967|2-Sided|95.0|-0.9|0.9|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679695|NCT01252186|3089835|Superiority or Other||Treatment Difference|-0.57||||0.194|2-Sided|95.0|-1.4|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679696|NCT01252186|3089836|Superiority or Other||Treatment Difference|-0.006||||0.173|2-Sided|95.0|-0.015|0.003|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679697|NCT01252186|3089836|Superiority or Other||Treatment Difference|-0.004||||0.331|2-Sided|95.0|-0.013|0.004|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679698|NCT01252186|3089837|Superiority or Other||Treatment Difference|-0.16||||0.081|2-Sided|95.0|-0.4|0.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679699|NCT01252186|3089837|Superiority or Other||Treatment Difference|0.09||||0.317|2-Sided|95.0|-0.1|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679700|NCT01252186|3089838|Superiority or Other||Treatment Difference|0.2||||0.012|2-Sided|95.0|0.0|0.3|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679701|NCT01252186|3089838|Superiority or Other||Treatment Difference|-0.01||||0.868|2-Sided|95.0|-0.2|0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679702|NCT01252186|3089839|Superiority or Other||Treatment Difference|-0.16||||0.002|2-Sided|95.0|-0.3|-0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679703|NCT01252186|3089839|Superiority or Other||Treatment Difference|-0.04||||0.428|2-Sided|95.0|-0.1|0.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679785|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.77||||0.2139|2-Sided|95.0|0.51|1.16|||Log Rank|||Subgroup analysis: ≥ 65 years of age|
1679786|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.77||||0.0229|2-Sided|95.0|0.62|0.97|||Log Rank|||Subgroup analysis: < 65 years of age|
1679704|NCT01252186|3089840|Superiority or Other||Treatment Difference|97.09||||0.131|2-Sided|95.0|-29.2|223.4|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679705|NCT01252186|3089840|Superiority or Other||Treatment Difference|-17.14||||0.782|2-Sided|95.0|-139.4|105.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679706|NCT01252186|3089841|Superiority or Other||Treatment Difference|71.31||||0.115|2-Sided|95.0|-17.5|160.1|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679707|NCT01252186|3089841|Superiority or Other||Treatment Difference|-14.31||||0.745|2-Sided|95.0|-100.8|72.2|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel - 91-day Levonorgestrel)|The endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679708|NCT01252186|3089842|Non-Inferiority or Equivalence|A conclusion of non-inferiority was reached if the lower limit of the confidence interval for the comparison (active control minus 91-day Levonorgestrel) was greater than -0.13 nmol/L (130 pmol/L).|Treatment Difference|422.76||||0.06|2-Sided|95.0|-18.3|863.8|||Mixed Models Analysis||Treatment difference is calculated as (28-day Desogestrel – 91-day Levonorgestrel)|The primary endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679709|NCT01252186|3089842|Non-Inferiority or Equivalence|A conclusion of non-inferiority was reached if the lower limit of the confidence interval for the comparison (active control minus 91-day Levonorgestrel) was greater than -0.13 nmol/L (130 pmol/L).|Treatment Difference|-11.54||||0.958|2-Sided|95.0|-440.1|417.0|||Mixed Models Analysis||Treatment difference is calculated as (28-day Levonorgestrel – 91-day Levonorgestrel)|The primary endpoint was analyzed using a maximum likelihood-based mixed model repeated measures (MMRM) analysis of covariance (ANCOVA) with covariate adjustment for baseline, treatment, month, and the treatment-by-month interaction.|
1679710|NCT01251861|3089861|Other|The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.||||||0.28||||||p-value based on logistic regression with adjustment for treatment assignment|Regression, Logistic|||The association between PSA response (responder vs non-responder) and prior hormonal therapy (yes vs. no) was evaluated by logistic regression with adjustment for treatment assignment.|
1679711|NCT01251861|3089862|Other|The association between PSA response (responder vs non-responder) and Gleason score (<7, 7 vs. >7) was evaluated by logistic regression with adjustment for treatment assignment.||||||0.5||||||p-value based on logistic regression with adjustment for treatment assignment|Regression, Logistic|||The association between PSA response (responder vs non-responder) and Gleason score (<7, 7 vs. >7) was evaluated by logistic regression with adjustment for treatment assignment.|
1679712|NCT01251861|3089871|Superiority|||||||0.28||||||one-sided|Fisher Exact||||
1679713|NCT01251770|3089872|Superiority or Other|||||||0.895|||||||t-test, 2 sided||||
1679714|NCT01251770|3089873|Superiority or Other|||||||0.871|||||||t-test, 2 sided|||Serum Sodium at the end of the study|
1679715|NCT01251770|3089873|Superiority or Other|||||||0.03|||||||t-test, 2 sided|||Serum Sodium difference at the beginning|
1679716|NCT01251757|3089874|Superiority or Other||Odds Ratio (OR)|1.1||||0.058|2-Sided|95.0|1.0|1.22||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.|Though higher for the IVR+ group, LDL control did not differ significantly between the IVR+ and UC arms. Among those with poor initial control, however, control was sig better for the IVR+ arm (OR = 1.21, 95%CI = (1.04, 1.42), p=.015).|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.|
1679717|NCT01251757|3089874|Superiority or Other||Odds Ratio (OR)|1.03||||0.59|2-Sided|95.0|0.93|1.13||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.|
1679718|NCT01251757|3089875|Superiority or Other||Mean Difference (Final Values)|-1.5||||0.019|2-Sided|95.0|-2.7|-0.2||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.|MeanLDL levels were sig lower for IVR+ participants than for UC participants. In subgroup analyses this difference was most pronounced in those individuals with baseline LDL levels above 100 mg/dL (adj diff=-3.6 mg/dL, 95%CI= (-5.9, -1.3), p=.002).|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL level subgroups.|
1679787|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.73||||0.1797|2-Sided|95.0|0.46|1.16|||Log Rank|||Subgroup analysis: LDH > 1.5 ULN|
1679996|NCT01245439|3090741|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||IN assessment Visit 3 to Visit 4|
1679719|NCT01251757|3089875|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.38|2-Sided|95.0|-1.8|0.7||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline LDL group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline LDL subgroups.|
1679720|NCT01251757|3089876|Superiority or Other||Odds Ratio (OR)|0.96||||0.54|2-Sided|95.0|0.85|1.09||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.|
1679721|NCT01251757|3089876|Superiority or Other||Odds Ratio (OR)|1.05||||0.404|2-Sided|95.0|0.93|1.19||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Logistic|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.|
1679722|NCT01251757|3089877|Superiority or Other||Mean Difference (Final Values)|0.0||||0.93|2-Sided|95.0|-0.5|0.5||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline SBP group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.|
1679723|NCT01251757|3089877|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.041|2-Sided|95.0|-1.0|0.0||As noted above, the a priori threshold for statistical significance for this test was .025.|Regression, Linear|Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline SBP group.||We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline SBP level groups.|
1679724|NCT01251757|3089878|Superiority or Other||Odds Ratio (OR)|1.21|||<|0.001|2-Sided|95.0|1.1|1.32||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.|
1679725|NCT01251757|3089878|Superiority or Other||Odds Ratio (OR)|1.12|||<|0.014|2-Sided|95.0|1.02|1.23||adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.|
1679726|NCT01251757|3089879|Superiority or Other||Odds Ratio (OR)|1.16|||<|0.001|2-Sided|95.0|1.06|1.26||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.|
1679727|NCT01251757|3089879|Superiority or Other||Odds Ratio (OR)|1.14|||<|0.002|2-Sided|95.0|1.05|1.24||Adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Regression, Logistic||Adjusted odds ratio for good adherence in IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.|
1679728|NCT01251757|3089880|Superiority or Other||Mean Difference (Final Values)|0.037|||<|0.001|2-Sided|95.0|0.023|0.05|||Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.|
1679788|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.77||||0.0171|2-Sided|95.0|0.62|0.96|||Log Rank|||Subgroup analysis: LDH ≤ 1.5 ULN|
1679789|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.41||||0.0029|2-Sided|95.0|0.22|0.75|||Log Rank|||Subgroup analysis: vinorelbine chemo|
1679790|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.84||||0.1385|2-Sided|95.0|0.68|1.06|||Log Rank|||Subgroup analysis: non-taxane chemo|
1679729|NCT01251757|3089880|Superiority or Other||Mean Difference (Final Values)|0.016|||<|0.022|2-Sided|95.0|0.002|0.029|||Regression, Linear|Adjusted for site, gender, age, total number of prescription medications participant was taking, comorbid diabetes/CVD, baseline ACEI/ARB adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.|
1679730|NCT01251757|3089881|Superiority or Other||Mean Difference (Final Values)|0.03|||<|0.001|2-Sided|95.0|0.019|0.042|||Regression, Linear|adjusted for site, gender, age, total number of prescription medications participant is taking, comorbid diabetes/CVD, and baseline statin adherence.|Adjusted difference in adherence for IVR+ group versus UC group, calculated as IVR+ - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR+ versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.|
1679731|NCT01251757|3089881|Superiority or Other||Mean Difference (Final Values)|0.022|||<|0.001|2-Sided|95.0|0.011|0.034|||Regression, Linear|adjusted for site, gender, age, total number of prescription medications patient is taking, comorbid diabetes/CVD, and baseline statin adherence.|Adjusted difference in adherence for IVR group versus UC group, calculated as IVR - UC.|We conducted separate primary analyses of each of IVR and IVR+ versus usual care at the .025 level of significance to assure a trial-wide error rate of .05. This analysis summary is for the IVR versus UC comparison only. Also, we only report results here for the full sample, and not also separately for the 3 baseline adherence level groups.|
1679732|NCT01251653|3089925|Non-Inferiority or Equivalence|p−value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|85.74|Standard Deviation|48.9||0.3294|2-Sided|90.0|65.561|112.138|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).||
1679733|NCT01251653|3089925|Non-Inferiority or Equivalence|p−value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|90.78|Standard Deviation|22.8||0.0728|2-Sided|90.0|78.566|104.901|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).||
1679734|NCT01251653|3089926|Non-Inferiority or Equivalence|p−value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|98.11|Standard Deviation|30.4||0.0405|2-Sided|90.0|81.053|118.76|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).||
1679735|NCT01251653|3089926|Non-Inferiority or Equivalence|p−value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|93.69|Standard Deviation|19.5||0.0349|2-Sided|90.0|81.352|107.89|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Docetaxel with Afatinib vs. Docetaxel without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).||
1679736|NCT01251653|3089929|Non-Inferiority or Equivalence|p−value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|118.41|Standard Deviation|31.6||0.3359|2-Sided|90.0|94.81|147.88|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Gemcitabine with Afatinib vs. Gemcitabine without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).||
1679737|NCT01251653|3089930|Non-Inferiority or Equivalence|p−value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|136.11|Standard Deviation|26.3||0.7759|2-Sided|90.0|112.09|165.29|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Gemcitabine with Afatinib vs. Gemcitabine without Afatinib was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).||
1679738|NCT01251653|3089931|Non-Inferiority or Equivalence|p−value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|83.95|Standard Deviation|14.3||0.2327|2-Sided|90.0|74.794|94.217|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).||
1679739|NCT01251653|3089931|Non-Inferiority or Equivalence|p−value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|77.42|Standard Deviation|16.8||0.6805|2-Sided|90.0|68.516|87.473|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).||
1679791|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.55||||0.0395|2-Sided|95.0|0.31|0.98|||Log Rank|||Subgroup analysis: taxane chemo|
1679792|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.82||||0.0816|2-Sided|95.0|0.65|1.03|||Log Rank|||Subgroup analysis: PFS ≥6 months|
1679793|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.62||||0.011|2-Sided|95.0|0.43|0.9|||Log Rank|||Subgroup analysis: PFS <6 months|
1679740|NCT01251653|3089931|Non-Inferiority or Equivalence|p−value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|141.36|Standard Deviation|14.7||0.8715|2-Sided|90.0|115.848|172.495|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Afatinib with Gemcitabine vs. Afatinib without Gemcitabine was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).||
1679741|NCT01251653|3089932|Non-Inferiority or Equivalence|p−value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|88.12|Standard Deviation|9.2||0.0208|2-Sided|90.0|81.778|94.964|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).||
1679742|NCT01251653|3089932|Non-Inferiority or Equivalence|p−value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|95.36|Standard Deviation|15.4||0.0149|2-Sided|90.0|84.139|108.077|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Afatinib with Docetaxel vs. Afatinib without Docetaxel was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).||
1679743|NCT01251653|3089932|Non-Inferiority or Equivalence|p−value for ratio outside interval 80% to 125%|Ratio of adjusted gmeans in percentage|81.27|Standard Deviation|63.3||0.4815|2-Sided|90.0|44.863|147.205|||ANOVA|ANOVA (analysis of variance) model on the logarithm scale was used with ‘subject’ as random, whereas the ‘treatment’ as fixed effect.|Relative bioavailability of Afatinib with Gemcitabine vs. Afatinib without Gemcitabine was estimated by the ratios of the adjusted geometric means (gMean). Standard deviation is actually intra-individual geometric coefficient variation (gCV).||
1679744|NCT01251614|3089955|Superiority or Other||Hazard Ratio (HR)|1.51||||0.276|2-Sided|95.0|0.71|3.21|||Log Rank|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.|
1679745|NCT01251614|3089955|Superiority or Other||Hazard Ratio (HR)|1.45||||0.343|2-Sided|95.0|0.66|3.17|||Log Rank|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.|
1679746|NCT01251614|3089956|Superiority or Other||Difference|-28.3||||0.113|2-Sided|95.0|-60.6|4.0|||Chi-squared|||"The difference between the combined adalimumab 0.8 mg/kg + MTX groups versus the adalimumab 0.4 mg/kg group.~Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were to be 2-sided with the significance level of 5%. Statistically significant results (P value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank."|
1679747|NCT01251614|3089957|Superiority or Other||Difference|-8.88||||0.005|2-Sided|95.0|-14.94|-2.82|||ANOVA|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.|
1679748|NCT01251614|3089958|Superiority or Other||Difference|1.61||||0.304|2-Sided|95.0|-1.48|4.7|||ANOVA|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.|
1679749|NCT01251614|3089959|Superiority or Other||Difference|-15.7||||0.056|2-Sided|95.0|-29.1|-2.3|||Fisher Exact|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.|
1679750|NCT01251614|3089960|Superiority or Other||Difference|-7.3||||0.466|2-Sided|95.0|-26.9|12.3|||Chi-squared|||Statistical comparisons for the ranked secondary endpoints were carried out in hierarchical order. All statistical tests were 2-sided with the significance level of 5%. Statistically significant results (p-value ≤ 0.05) must have been achieved for a comparison in the higher rank in order to initiate the next comparison in the lower rank.|
1679751|NCT01251614|3089961|Superiority or Other||Difference|-20.0||||0.083|2-Sided|95.0|-42.2|2.2|||Chi-squared|||"The a priori defined order of the statistical hypotheses was as follows:~Superiority of adalimumab 0.8 mg/kg versus MTX for the percentage of participants achieving a ≥ PASI 75 response at Week 16.~Superiority of adalimumab 0.8 mg/kg versus MTX, for the percentage of participants achieving a PGA cleared or minimal at Week 16.~This order was adhered to for confirmatory testing, all statistical tests were at a level of significance of 5% and the overall type I error was preserved."|
1679752|NCT01251614|3089962|Superiority or Other||Difference|-25.5||||0.027|2-Sided|95.0|-47.2|-3.7|||Chi-squared|||"The a priori defined order of the statistical hypotheses was as follows:~Superiority of adalimumab 0.8 mg/kg versus MTX for the percentage of participants achieving a ≥ PASI 75 response at Week 16.~Superiority of adalimumab 0.8 mg/kg versus MTX, for the percentage of participants achieving a PGA cleared or minimal at Week 16.~This order was adhered to for confirmatory testing, all statistical tests were at a level of significance of 5% and the overall type I error was preserved."|
1679794|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.84||||0.1196|2-Sided|95.0|0.67|1.05|||Log Rank|||Subgroup analysis: HR-pos/HER-neg|
1679795|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.59||||0.0088|2-Sided|95.0|0.4|0.88|||Log Rank|||Subgroup analysis: HR-neg|
1679796|NCT01250379|3090202|Superiority or Other||Hazard Ratio (HR)|0.81||||0.0245|2-Sided|95.0|0.67|0.97|||Log Rank||Unstratified analysis.||
1679753|NCT01251393|3089998|Equivalence|"The comparisons between the placebo and the biperiden groups at baseline were performed by means of the independent t-Test. We evaluated the normality (Kolmogorov’s test) and homogeneity (Levene’s test) of the sample.~We used an ANOVA for repeated measures, followed by Bonferroni’s post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack."|||||<|0.05||||||We used an ANOVA for repeated measures, followed by Bonferroni’s post-hoc test to evaluate the efficacy of biperiden in reducing consumption of cocaine/crack.|ANOVA|||We evaluated the normality (Kolmogorov's test) and homogeneity (Levene's test) of the sample.|
1679754|NCT01251042|3090087|Non-Inferiority or Equivalence|Information about the size of the standard deviation (SD) for the change was obtained from an earlier study. The SD for the change from pre-operation until 24 hours after start of transfusion was 0.2305. Due to the imprecise measuring device (if values below 0.3 g/l) and the large SD, a non-inferiority margin (∆) of 0.2 g/l was decided to be used in this study, resulting in a total number of 42 evaluable subjects, i.e. 21 subjects per group.||||||0.6294|||||||Wilcoxon (Mann-Whitney)||||
1679755|NCT01250990|3090092|Superiority or Other|||||||0.8||||||p value is for comparison between changes in reverse cholesterol transport in niacin versus placebo groups after 12 weeks of treatment.|t-test, 2 sided|||This is a pilot study to assess the effects of niacin on reverse cholesterol transport. The null hypothesis is that niacin has no effect on reverse cholesterol transport.|
1679756|NCT01250899|3090108|Superiority or Other||Percentage of 12-wk 25(OH)D ≥30ng/mL|70.0|||<|0.05|2-Sided|95.0|60.0|80.0|||Exact binomial||The primary endpoint (mean change in 25(OH)D following 12 weeks of vitamin D repletion in vitamin D insufficient subjects) was dichotomized to success or failure to achieve a week twelve 25(OH)D level ≥30ng/mL.|We predicted that HIV-infected subjects would have a 70% twelve-week repletion success rate compared to 85% among historical controls.Eighty subjects provided 91% power to detect a 12-week repletion rate statistically different than 85% (95% confidence interval (CI) 60%, 80%).|
1679757|NCT01250873|3090109|Superiority or Other||Median Difference (Final Values)|1.0||||0.3125|2-Sided|90.0|0.0|2.0|||Wilcoxon (Mann-Whitney)||||
1679758|NCT01250873|3090110|Superiority or Other||Ratio of Geometric LS Means|1.22|||||2-Sided|90.0|1.1|1.36|||||||
1679759|NCT01250873|3090111|Superiority or Other||Ratio of Geometric LS Means|1.27|||||2-Sided|90.0|1.17|1.39|||||||
1679760|NCT01250873|3090112|Superiority or Other||Median Difference (Final Values)|0.0||||0.8281|2-Sided|90.0|-0.5|1.0|||Wilcoxon (Mann-Whitney)||||
1679761|NCT01250873|3090113|Superiority or Other||Ratio of Geometric LS Means|1.14|||||2-Sided|90.0|1.01|1.28|||||||
1679762|NCT01250873|3090114|Superiority or Other||Ratio of Geometric LS Means|1.17|||||2-Sided|90.0|1.06|1.3|||||||
1679763|NCT01250717|3090171|Superiority or Other||Percentage|0.0|||||2-Sided|95.0|0.0|0.12|||||||
1679764|NCT01250379|3090188|Superiority or Other||Hazard Ratio (HR)|0.93||||0.5332|2-Sided|95.0|0.75|1.16|||Log Rank||Unstratified analysis.||
1679765|NCT01250379|3090188|Superiority or Other||Hazard Ratio (HR)|0.96||||0.7253|2-Sided|95.0|0.76|1.21|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.||
1679766|NCT01250379|3090191|Superiority or Other||Hazard Ratio (HR)|0.81||||0.0503|2-Sided|95.0|0.66|1.0|||Log Rank||Unstratified analysis.||
1679767|NCT01250379|3090191|Superiority or Other||Hazard Ratio (HR)|0.81||||0.0744|2-Sided|95.0|0.65|1.02|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.||
1679768|NCT01250379|3090193|Superiority or Other||Hazard Ratio (HR)|0.84||||0.0863|2-Sided|95.0|0.68|1.03|||Log Rank||Unstratified analysis.||
1679769|NCT01250379|3090193|Superiority or Other||Hazard Ratio (HR)|0.85||||0.1349|2-Sided|95.0|0.68|1.05|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.||
1679770|NCT01250379|3090195|Superiority or Other||Hazard Ratio (HR)|0.78||||0.0625|2-Sided|95.0|0.59|1.02|||Log Rank||Unstratified analysis.||
1679771|NCT01250379|3090195|Superiority or Other||Hazard Ratio (HR)|0.79||||0.108|2-Sided|95.0|0.59|1.06|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.||
1679772|NCT01250379|3090198|Superiority or Other||Hazard Ratio (HR)|1.31||||0.3601|2-Sided|95.0|0.73|2.34|||Log Rank||Unstratified analysis.||
1679773|NCT01250379|3090198|Superiority or Other||Hazard Ratio (HR)|1.01||||0.9825|2-Sided|95.0|0.51|1.99|||Log Rank||The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.||
1679774|NCT01250379|3090200|Superiority or Other||Mean Difference (Final Values)|4.1||||0.3457|2-Sided|95.0|-4.2|12.4|||Chi-squared||The 95% CI was estimated using Hauck-Anderson methodology.||
1679775|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.83||||0.1143|2-Sided|95.0|0.66|1.05|||Log Rank|||Subgroup analysis: D-free > 12 months|
1679776|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.52||||0.0568|2-Sided|95.0|0.26|1.03|||Log Rank|||Subgroup analysis: D-free ≤ 12 months|
1679777|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.85||||0.2318|2-Sided|95.0|0.66|1.11|||Log Rank|||Subgroup analysis: D-free > 24 months|
1679778|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.62||||0.0176|2-Sided|95.0|0.41|0.92|||Log Rank|||Subgroup analysis: D-free ≤ 24 months|
1679779|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.72||||0.0489|2-Sided|95.0|0.51|1.0|||Log Rank|||Subgroup analysis: B-free > 6 weeks|
1679780|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.82||||0.0967|2-Sided|95.0|0.64|1.04|||Log Rank|||Subgroup analysis: B-free ≤ 6 weeks|
1679781|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.84||||0.3102|2-Sided|95.0|0.61|1.17|||Log Rank|||Subgroup analysis: ≥ 3 metastatic organ sites|
1679782|NCT01250379|3090201|Superiority or Other||Hazard Ratio (HR)|0.74||||0.0148|2-Sided|95.0|0.58|0.94|||Log Rank|||Subgroup analysis: < 3 metastatic organ sites|
1679797|NCT01250379|3090202|Superiority or Other||Hazard Ratio (HR)|0.79||||0.0204|2-Sided|95.0|0.65|0.97|||Log Rank||The 95% confidence interval (CI) was estimated using Cox proportional hazards methodology. The stratification factors used in the analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and lactate dehydrogenase (LDH) level.||
1679798|NCT01250119|3090232|Superiority or Other|||||||0.0001|||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for smoking history; Multivariate analysis (6 main effects only).|||
1679799|NCT01250119|3090232|Superiority or Other|||||||0|||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for smoking history; Univariate analysis.|||
1679800|NCT01250119|3090232|Superiority or Other|||||||0.3371|||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for race; Multivariate analysis (6 main effects only).|||
1679801|NCT01250119|3090232|Superiority or Other|||||||0.0004|||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for race; Univariate analysis.|||
1679802|NCT01250119|3090232|Superiority or Other|||||||0.0006|||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for gender; Multivariate analysis (6 main effects only).|||
1679803|NCT01250119|3090232|Superiority or Other|||||||0|||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for gender; Univariate analysis.|||
1679804|NCT01250119|3090232|Superiority or Other|||||||0.1181|||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for age at consent; Multivariate analysis (6 main effects only).|||
1679805|NCT01250119|3090232|Superiority or Other|||||||0.0147|||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for age at consent; Multivariate analysis (6 main effects only).|||
1679806|NCT01250119|3090232|Superiority or Other|||||||0.4802|||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for stage of disease; Multivariate analysis (6 main effects only).|||
1679807|NCT01250119|3090232|Superiority or Other|||||||0.0588|||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for stage of disease; Univariate analysis.|||
1679808|NCT01250119|3090232|Superiority or Other|||||||0.1038|||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for histopathology; Multivariate analysis (6 main effects only).|||
1679809|NCT01250119|3090232|Superiority or Other|||||||0|||||||Wald Test|Test for difference in incidence of EGFR mutations for each subgroup controlled for histopathology; Univariate analysis.|||
1679810|NCT01249833|3090244|Superiority or Other||LS Means Difference|3.3||||0.1162|2-Sided|95.0|-0.8|7.4|||ANCOVA||The LS means of Standard of Care Alone was subtracted from that of Oseltamivir.|Contentedness: the higher the value, the greater the contentedness.|
1679811|NCT01249833|3090244|Superiority or Other||LS Means Difference|-0.6||||0.7219|2-Sided|95.0|-4.1|2.9|||ANCOVA||The LS means for Standard of Care AL one was subtracted from that of Oseltamivir.|Calmness: the higher the value, the greater the calmness.|
1679812|NCT01249833|3090244|Superiority or Other||LS Means Difference|1.9||||0.3195|2-Sided|95.0|-1.9|5.7|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.|Alertness: the higher the value, the greater the alertness.|
1679813|NCT01249833|3090245|Superiority or Other||LS Means Difference|3.9||||0.9685|2-Sided|95.0|-190.1|197.9|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.||
1679814|NCT01249833|3090246|Superiority or Other||LS Means Difference|3.8||||0.0054|2-Sided|95.0|1.14|6.42|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.||
1679815|NCT01249833|3090247|Superiority or Other||LS Means Difference|-30.4||||0.0492|2-Sided|95.0|-60.7|-0.1|||ANCOVA||The LS means for Standard of Care Alone was subtracted from that of Oseltamivir.||
1679816|NCT01249664|3090248|Superiority or Other||Difference in least square means|-0.6648|||<|0.0001|2-Sided|95.0|-0.8056|-0.5239|||ANCOVA||||
1679817|NCT01249664|3090250|Superiority or Other||Difference of least square means|5.21||||0.0104|2-Sided|95.0|1.25|9.18|||ANCOVA||||
1679818|NCT01249664|3090251|Superiority or Other||Difference in least square means|-0.0045||||0.869|2-Sided|95.0|-0.0579|0.049|||ANCOVA||||
1679819|NCT01249664|3090252|Superiority or Other||Difference in least square means|-0.1346||||0.0256|2-Sided|95.0|-0.2525|-0.0167|||ANCOVA||||
1679820|NCT01249664|3090253|Superiority or Other||Difference in least square means|-0.4808|||<|0.0001|2-Sided|95.0|-0.599|-0.3626|||ANCOVA||||
1679821|NCT01249664|3090254|Superiority or Other||Difference in least square means|-29.3||||0.065|2-Sided|95.0|-60.4|1.8|||ANCOVA||||
1679822|NCT01249664|3090255|Superiority or Other||Difference in least square means|-77.9|||<|0.0001|2-Sided|95.0|-108.9|-46.9|||ANCOVA||||
1679823|NCT01249664|3090256|Superiority or Other||CMH adjusted difference|-25.7||||0.0012|2-Sided|95.0|-41.3|-10.1|||Cochran-Mantel-Haenszel||||
1679824|NCT01249664|3090257|Superiority or Other||CMH adjusted difference|-21.5||||0.0035|2-Sided|95.0|-35.9|-7.0|||Cochran-Mantel-Haenszel||||
1679825|NCT01249664|3090258|Superiority or Other||CMH adjusted difference|-5.3||||0.2446|2-Sided|95.0|-14.4|3.7|||Cochran-Mantel-Haenszel||||
1679826|NCT01249664|3090259|Superiority or Other||CMH adjusted difference|-32.2|||<|0.0001|2-Sided|95.0|-48.1|-16.3|||Cochran-Mantel-Haenszel||||
1679827|NCT01249664|3090260|Superiority or Other||CMH adjusted difference|-25.8||||0.0006|2-Sided|95.0|-40.6|-11.0|||Cochran-Mantel-Haenszel||||
1679828|NCT01249664|3090261|Superiority or Other||CMH adjusted difference|-6.5||||0.1478|2-Sided|95.0|-15.2|2.3|||Cochran-Mantel-Haenszel||||
1679829|NCT01249664|3090262|Superiority or Other||CMH adjusted difference|42.7|||<|0.0001|2-Sided|95.0|23.7|61.6|||Cochran-Mantel-Haenszel||||
1679830|NCT01249664|3090263|Superiority or Other||CMH adjusted difference|27.0||||0.0075|2-Sided|95.0|7.2|46.8|||Cochran-Mantel-Haenszel||||
1679831|NCT01249664|3090264|Superiority or Other||CMH adjusted difference|21.0||||0.0308|2-Sided|95.0|1.9|40.1|||Cochran-Mantel-Haenszel||||
1679832|NCT01249664|3090265|Superiority or Other||CMH adjusted difference|64.0|||<|0.001|2-Sided|95.0|47.8|80.3|||Cochran-Mantel-Haenszel||||
1679833|NCT01249664|3090266|Superiority or Other||CMH adjusted difference|50.5|||<|0.001|2-Sided|95.0|35.0|66.0|||Cochran-Mantel-Haenszel||||
1679834|NCT01249664|3090267|Superiority or Other||Difference in least square means|13.1|||<|0.0001|2-Sided|95.0|9.4|16.7|||ANCOVA||||
1679835|NCT01249664|3090268|Superiority or Other||CMH adjusted difference|29.2||||0.0001|2-Sided|95.0|14.4|44.0||No adjustment on P value, since this test was only conducted formally under the primary efficacy evaluation was significant.|Cochran-Mantel-Haenszel||A two-sided Cochran-Mantel-Haenszel method at level 5% weight-adjusted by country (country designations) was used to conduct the superiority test.|Null hypothesis of difference of Eylea minus Sham of 0 was tested.|
1679836|NCT01249664|3090269|Superiority or Other||Difference in least square means|14.1|||<|0.0001|2-Sided|95.0|10.8|17.4||No adjustment on P value, this is for the primary efficacy analysis.|ANCOVA|ANCOVA model, including treatment groups and country (country designations) as fixed effects and baseline BCVA as a covariate.|The difference is calculated as Eylea minus Sham. A positive value indicates Eylea showed a higher change in BCVA total score until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in BCVA total letter score between Eylea and Sham.|
1679837|NCT01249651|3090273|Superiority or Other||||||<|0.001|||||||Wilocoxon signed-rank test|||Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.|
1679838|NCT01249417|3090280|Superiority or Other||LS mean difference|4.65||||0.0031|2-Sided|95.0|1.59|7.71|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.|
1679839|NCT01249417|3090280|Superiority or Other||Difference in LS means|5.32||||0.0006|2-Sided|95.0|2.31|8.32|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.|
1679840|NCT01249417|3090281|Superiority or Other||Difference in LS means|0.77|||<|0.0001|2-Sided|95.0|0.45|1.1|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.|
1679841|NCT01249417|3090281|Superiority or Other||Difference in LS means|0.82|||<|0.0001|2-Sided|95.0|0.5|1.14|||ANOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANOVA on the visit value with treatment, age range at baseline, BTX status at baseline and centre as covariates.|
1679842|NCT01249417|3090282|Superiority or Other||Difference in LS means|-0.49||||0.0002|2-Sided|95.0|-0.75|-0.23|||ANCOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, age range at baseline, BTX status at baseline and centre as covariates.|
1679843|NCT01249417|3090282|Superiority or Other||Difference in LS means|-0.38||||0.0029|2-Sided|95.0|-0.64|-0.13|||ANCOVA|||LS means for each treatment group and treatment comparisons, as well as the p-values were obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, age range at baseline, BTX status at baseline and centre as covariates.|
1679844|NCT01249404|3090304|Superiority or Other||LS mean difference|-0.01|||=|0|2-Sided|95.0|-0.03|0.02|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.|
1679845|NCT01249404|3090304|Superiority or Other||LS mean difference|0.01|||=|0|2-Sided|95.0|-0.02|0.03|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.|
1679846|NCT01249404|3090305|Superiority or Other||LS mean difference|0.2||||0.0406|2-Sided||||||ANCOVA on rank PGA scores||LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.|The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.|
1679847|NCT01249404|3090305|Superiority or Other||LS mean difference|0.2||||0.0466|2-Sided||||||ANCOVA on rank PGA scores||LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.|The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.|
1679848|NCT01249404|3090305|Superiority or Other||LS mean difference|0.3|||=|0|2-Sided|95.0|0.0|0.5|||ANCOVA||LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.|The mean PGA at Week 4 in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.|
1679866|NCT01249118|3090348|Superiority or Other||Ratio of LS Means|45.9|||||2-Sided|90.0|39.74|53.06|||||The 90% CI of the test group (oral dose) means relative to the reference group (IV dose) means were obtained by taking the antilog of the corresponding 90% CI for the differences between the means on the log scale.|LS mean was calculated from ANOVA. Data for dose-normalized AUC (0 - ∞) were natural log-transformed prior to analysis.|
1679849|NCT01249404|3090305|Superiority or Other||LS mean difference|0.3|||=|0|2-Sided|95.0|0.0|0.5|||ANCOVA||LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.|The mean PGA at Week 4 in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.|
1679850|NCT01249404|3090306|Superiority or Other||LS mean difference|-0.3|||=|0|2-Sided|95.0|-0.5|-0.1|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.|
1679851|NCT01249404|3090306|Superiority or Other||Least squares (LS) mean difference|-0.1|||=|0|2-Sided|95.0|-0.3|0.1|||ANCOVA||LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.|The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.|
1679852|NCT01249274|3090310|Superiority or Other||Cox Proportional Hazard|3.5||||0.06|2-Sided|95.0|0.92|13.3|||Regression, Cox||Ratio presented is for placebo versus progesterone||
1679853|NCT01249274|3090311|Superiority or Other||Cox Proportional Hazard|4.71||||0.048|2-Sided|95.0|1.09|20.5|||Regression, Cox||Ratio presented is for placebo versus progesterone||
1679854|NCT01249274|3090314|Superiority or Other||Score Statistic For Type 3 GEE Analysis|0.01||||0.9116|2-Sided||||||Generalized Estimating Equation|Gamma distribution, logit link, 1st-order autoregressive covariance structure; p-value is for chi-sq (df=1) for type 3 GEE analysis score statistic|Estimated value is chi-sq (df=1) for type 3 GEE analysis score statistic for week*treatment interaction term.||
1679855|NCT01249274|3090315|Superiority or Other|||||||0.103|||||||Fisher Exact||||
1679856|NCT01249274|3090316|Superiority or Other||Risk Ratio (RR)|1.18||||0.84|2-Sided|95.0|0.24|5.84|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is RR for treatment*time interaction for placebo at week 12. Time was treated as a 3-level categorical variable; week 0 (ref), week 12 & 3-month post-trial follow-up. Treatment variable reference group was progesterone.||
1679857|NCT01249274|3090316|Superiority or Other||Risk Ratio (RR)|1.34||||0.75|2-Sided|95.0|0.23|7.88|||Generalized Estimating Equation||Estimated value is RR for treatment*time interaction for placebo at 3-mo post-trial follow-up. Time treated as a 3-level categorical variable; week 0 (ref), week 12 & 3-month post-trial follow-up. Treatment variable reference group was progesterone.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p<0.05) difference between groups if the effect size for the primary outcome was large.|
1679858|NCT01249274|3090317|Superiority or Other||Risk Ratio (RR)|1.0||||0.99|2-Sided|95.0|0.87|1.15|||Generalized Estimating Equation||Estimated value is the risk ratio for the treatment x time interaction term. Time was treated as a continuous variable and progesterone was the reference group for treatment.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p<0.05) difference between groups if the effect size for the primary outcome was large.|
1679859|NCT01249274|3090318|Superiority or Other||Risk Ratio (RR)|16.65||||0.038|2-Sided|95.0|1.18|235.52|||Generalized Estimating Equation||Estimated value is RR for treatment*time interaction term for placebo at week 12. Time was treated as a 3-level categorical variable; week 0 (ref), week 12 and 3-month post-trial follow-up. Treatment variable reference group was progesterone.|Negative binomial distribution, log link, and first-order autoregressive covariance structure|
1679860|NCT01249274|3090318|Superiority or Other||Risk Ratio (RR)|30.39||||0.003|2-Sided|95.0|3.18|290.04|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is RR for treatment*time interaction for placebo at 3-mo post-trial follow-up. Time treated as a 3-level categorical variable; week 0 (ref), week 12 & 3-month post-trial follow-up. Treatment variable reference group was progesterone.|We calculated that a sample size of 50 women would have 80% power to detect a significant (p<0.05) difference between groups if the effect size for the primary outcome was large.|
1679861|NCT01249274|3090319|Superiority or Other||Risk Ratio (RR)|1.19||||0.01|2-Sided|95.0|1.04|1.36|||Generalized Estimating Equation|Negative binomial distribution, log link, and first-order autoregressive covariance structure|Estimated value is the risk ratio estimate for the treatment x time interaction term. Time was treated as a continuous variable and progesterone was the reference group for the treatment variable.||
1679862|NCT01249131|3090336|Superiority or Other||Ratio of LS Means (in %)|107.0|||||2-Sided|90.0|93.8|123.0|||||LS mean was calculated from ANOVA. Data for dose-normalized Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).||
1679863|NCT01249131|3090336|Superiority or Other||Ratio of LS Means (in %)|96.9|||||2-Sided|90.0|84.2|111.0|||||LS mean was calculated from ANOVA. Data for dose-normalized Cmax were natural log-transformed prior to analysis. Ratio of Cmax LS means for log-transformed parameter (expressed as a percent).||
1679864|NCT01249131|3090337|Superiority or Other||Ratio of LS Means (in %)|110.0|||||2-Sided|90.0|98.2|124.0|||||LS mean was calculated from ANOVA. Data for dose-normalized AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).||
1679865|NCT01249131|3090337|Superiority or Other||Ratio of Least Squares (LS) Means (in %)|94.7|||||2-Sided|90.0|83.9|107.0|||||LS mean was calculated from analysis of variance (ANOVA). Data for dose-normalized AUCinf were natural log-transformed prior to analysis. Ratio of AUCinf LS means for log-transformed parameter (expressed as a percent).||
1679997|NCT01245439|3090741|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||IN assessment Visit 2 to Visit 3|
1679867|NCT01249118|3090350|Superiority or Other||Ratio of LS Means|48.6|||||2-Sided|90.0|41.43|56.94|||||The 90% CI of the test group (oral dose) means relative to the reference group (IV dose) means were obtained by taking the antilog of the corresponding 90% CI for the differences between the means on the log scale.|LS means was calculated from ANOVA. Data for dose-normalized AUC (0 - t) were natural log-transformed prior to analysis.|
1679868|NCT01249118|3090354|Superiority or Other||Ratio of LS Means|8.45|||||2-Sided|90.0|7.08|10.08|||||The 90 percent (%) confidence intervals (CI) of test group (oral dose) means relative to reference group (IV dose) means were obtained by taking antilog of corresponding 90% CI for the differences between the means on the log scale.|Least squares (LS) mean was calculated from analysis of variance (ANOVA). Data for dose-normalized Cmax were natural log-transformed prior to analysis.|
1679869|NCT01249092|3090357|Superiority or Other||Mean Difference (Net)|-5.69|Standard Error of the Mean|8.66||0.5|2-Sided|95.0|-24.14|8.68||Hypothesis tested if TIMP-1 levels after therapy with pentoxifylline changed significantly from baseline from baseline.|Paired t-test.|||Change from baseline in TIMP-1 levels was assessed by paired-t test. Distribution the variable values was assessed using normal probability plots. Matched pairs t-test was used to compare the change from baseline.|
1679870|NCT01249092|3090358|Superiority or Other||Mean Difference (Final Values)|-57.3|Standard Deviation|62.1||0.001|2-Sided|95.0|-88.2|-26.4||This study tested the hypothesis that treatment with pentoxifylline would result in a statistically significant change from baseline in the level of alkaline phosphatase.|Paired t-test|||A p-value < 0.05 was considered statistically significant and all analyses were carried out using SAS version 9.2 (The SAS Institute, Cary, NC). Matched pairs t-test was used to compare the change in alkaline phosphatase from baseline. The efficacy of therapy was measured based on improvement in AP levels after therapy with PTX. AP levels at end of the study were compared with values at baseline by matched pairs t-test.|
1679871|NCT01248884|3090468|Non-Inferiority|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.92|||||2-Sided|97.5|-5.07|3.02||||||Immune response non-inferiority - anti-HBs (CLIA)|
1679872|NCT01248884|3090468|Non-Inferiority|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.4|||||2-Sided|97.5|-4.62|3.8||||||Immune response non-inferiority - anti-HBs (CLIA)|
1679873|NCT01248884|3090468|Non-Inferiority|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-0.94|||||2-Sided|97.5|-4.57|2.36||||||Immune response non-inferiority - anti-HBs (ELISA)|
1679874|NCT01248884|3090468|Non-Inferiority|Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|0.56|||||2-Sided|97.5|-3.27|4.63||||||Immune response non-inferiority - anti-HBs (ELISA)|
1679875|NCT01248884|3090469|Non-Inferiority|Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|0.57|||||2-Sided|97.5|-6.53|7.7|||||||
1679876|NCT01248884|3090469|Non-Inferiority|Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.|Difference in percentage|-3.52|||||2-Sided|97.5|-10.19|3.0|||||||
1679877|NCT01248884|3090470|Non-Inferiority|Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.|GMC ratio|1.58|||||2-Sided|97.5|1.37|1.84|||||||
1679878|NCT01248884|3090470|Non-Inferiority|Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.|GMC ratio|1.25|||||2-Sided|97.5|1.1|1.43|||||||
1679879|NCT01248884|3090470|Non-Inferiority|Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.|GMC ratio|1.33|||||2-Sided|97.5|1.14|1.54|||||||
1679880|NCT01248884|3090470|Non-Inferiority|Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.|GMC ratio|1.26|||||2-Sided|97.5|1.11|1.44|||||||
1679881|NCT01248884|3090472|Non-Inferiority|Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||2-Sided|97.5|-2.25|2.27|||||||
1679882|NCT01248884|3090472|Non-Inferiority|Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||2-Sided|97.5|-2.25|2.27|||||||
1679883|NCT01248884|3090472|Non-Inferiority|Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||2-Sided|97.5|-2.25|2.3|||||||
1679998|NCT01245439|3090741|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||PT assessment Visit 2 to Visit 8|
1679884|NCT01248884|3090472|Non-Inferiority|Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.|Difference in percentage|0.0|||||2-Sided|97.5|-2.25|2.3|||||||
1679885|NCT01248780|3090478|Superiority or Other||||||<|0.001|||||||ANOVA||||
1679886|NCT01248780|3090479|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1679887|NCT01248780|3090480|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1679888|NCT01248780|3090481|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1679889|NCT01248728|3090482|Superiority or Other|||||||0.6|||||||Regression, Linear||||
1679890|NCT01248728|3090483|Superiority or Other|||||||0.09|||||||Mixed Models Analysis||||
1679891|NCT01248728|3090485|Superiority or Other|||||||0.02|||||||Mixed Models Analysis||||
1679892|NCT01248728|3090486|Superiority or Other|||||||0.5|||||||Mixed Models Analysis||||
1679893|NCT01248715|3090487|Superiority|||||||0.9999|||||||Wilcoxon (Mann-Whitney)||||
1679894|NCT01248715|3090488|Superiority|||||||0.796|||||||Wilcoxon (Mann-Whitney)||||
1679895|NCT01248715|3090489|Superiority|||||||0.685|||||||Wilcoxon (Mann-Whitney)||||
1679896|NCT01248715|3090490|Superiority|||||||0.9999|||||||Wilcoxon (Mann-Whitney)||||
1679897|NCT01248715|3090491|Superiority|||||||0.732|||||||Wilcoxon (Mann-Whitney)||||
1679898|NCT01248715|3090492|Superiority|||||||0.9999|||||||Wilcoxon (Mann-Whitney)||||
1679899|NCT01248715|3090493|Superiority|||||||0.46|||||||Wilcoxon (Mann-Whitney)||||
1679900|NCT01248455|3090499|Superiority or Other (legacy)|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||No patients obtained a 50% reduction in M-protein concentration and the study did not continue to the second stage of enrollment due to the lack of efficacy as defined by out criteria. This statistical analysis includes all participants (i.e., stable disease (SD), minimal response (MR), biochemical progression (BP), and progressive disease (PD)).|
1679901|NCT01248416|3090501|Superiority|||||||0.0003|||||||ANCOVA||||
1679902|NCT01248416|3090502|Superiority||||||<|0.0001|||||||ANOVA||||
1679903|NCT01248416|3090503|Superiority||||||<|0.0001|||||||ANOVA||||
1679904|NCT01248416|3090505|Superiority|||||||0.015|||||||ANOVA||||
1679905|NCT01248416|3090506|Superiority|||||||0.906|||||||ANOVA||||
1679906|NCT01248416|3090508|Superiority||||||<|0.006|||||||ANCOVA||||
1679907|NCT01248364|3090509|Superiority or Other||Mean Difference (Final Values)|-3.68|Standard Error of the Mean|3.38||0.2795|2-Sided|95.0|-10.41|3.05|||ANCOVA|Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.|
1679908|NCT01248364|3090510|Superiority or Other||Mean Difference (Final Values)|1.31|Standard Error of the Mean|2.93||0.6576|2-Sided|95.0|-4.53|7.14|||ANCOVA|Based on ANCOVA with terms for baseline EPG iAUC 5h, diagnosis group and baseline EPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.|
1679909|NCT01248364|3090511|Superiority or Other||Mean Difference (Final Values)|3.13|Standard Error of the Mean|1.89||0.1024|2-Sided|95.0|-0.64|6.9|||ANCOVA|Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.|
1679910|NCT01248364|3090512|Superiority or Other||Mean Difference (Final Values)|0.31|Standard Error of the Mean|0.99||0.7561|2-Sided|95.0|-1.66|2.27|||ANCOVA|Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.|
1679911|NCT01248364|3090513|Superiority or Other||Mean Difference (Final Values)|-1.58|Standard Error of the Mean|0.81||0.0552|2-Sided|95.0|-3.2|0.04|||ANCOVA|Based on ANCOVA with terms for baseline PPG iAUC 5h, diagnosis group and baseline PPG iAUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.|
1679912|NCT01248364|3090514|Superiority or Other||Mean Difference (Final Values)|5.48|Standard Error of the Mean|2.52||0.0326|2-Sided|95.0|0.47|10.5|||ANCOVA|Based on ANCOVA with terms for baseline EPG AUC 5h, diagnosis group and baseline EPG AUC 5h by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.|
1679913|NCT01248364|3090515|Superiority or Other||Mean Difference (Final Values)|1.84|Standard Error of the Mean|1.12||0.1028|2-Sided|95.0|-0.38|4.07|||ANCOVA|Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.|
1679914|NCT01248364|3090516|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.75||0.6931|2-Sided|95.0|-1.19|1.79|||ANCOVA|Based on ANCOVA with terms for baseline EPG fast, diagnosis group and baseline EPG fast by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.|
1679915|NCT01248364|3090517|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.2||0.2438|2-Sided|95.0|-0.16|0.62|||ANCOVA|Based on ANCOVA with terms for baseline FPG, diagnosis group and baseline FPG by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.|
1679916|NCT01248364|3090518|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.18||0.279|2-Sided|95.0|-0.16|0.55|||ANCOVA|Based on ANCOVA with terms for baseline FPG, diagnosis group, and baseline FPG by diagnosis group interaction.|Difference calculated as T2DM metformin minus T2DM Naive|No formal testing, exploratory analysis only.|
1679917|NCT01247324|3090579|Superiority or Other (legacy)||Relative risk (stratified)|1.74|||<|0.0001|2-Sided|95.0|1.39|2.17|||CMH Chi-Squared test (stratified)|Analyzed using CMH test, stratified by Geographical Region (US vs. rest-of-world) and baseline EDSS (<4.0 vs. >=4.0).|||
1679999|NCT01245439|3090741|Superiority or Other||||||<|0.047|||||||Wilcoxon Signed Rank test.|||PT assessment Visit 7 to Visit 8|
1679918|NCT01247324|3090580|Superiority or Other (legacy)||Difference in Adjusted Means|0.693|Standard Error of the Mean|0.564|=|0|2-Sided|95.0|-0.414|1.8|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.||
1679919|NCT01247324|3090581|Superiority or Other (legacy)||Difference in Adjusted Means|0.168|Standard Error of the Mean|0.058|=|0|2-Sided|95.0|0.053|0.283|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in the rate of brain volume loss: 22.8%. Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.||
1679920|NCT01247324|3090582|Superiority or Other (legacy)||Difference in Adjusted Means|0.039|Standard Error of the Mean|0.039|=|0|2-Sided|95.0|-0.039|0.116|||mixed-effect model of repeated measures|Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.|Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.||
1679921|NCT01247324|3090583|Superiority or Other (legacy)||Adjusted rate ratio|0.428|||<|0.0001||95.0|0.328|0.557|||Negative Binomial Model||Adjusted by baseline T1-hypointense lesion count, baseline EDSS (<4.0 vs. >=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.||
1679922|NCT01247324|3090584|Superiority or Other (legacy)||Hazard Ratio (HR)|0.57|||=|0|2-Sided|95.0|0.34|0.95|||Log Rank|||Time to onset CDP at week 24|
1679923|NCT01247324|3090585|Superiority or Other (legacy)||Relative risk (stratified)|1.61|||=|0|2-Sided|95.0|1.11|2.33|||CMH Chi-Squared test (stratified)|CMH (Cochran-Mantel-Haenszel) Chi-Squared test Stratified by Geographical Region (US vs. Rest of World) and Baseline EDSS (<4.0 vs. >=4.0)|||
1679924|NCT01247324|3090586|Superiority or Other (legacy)||Adjusted rate ratio|0.229|||<|0.0001||95.0|0.174|0.3|||Negative Binomial Model||Adjusted by baseline T2 lesion (present or not), baseline EDSS (<4.0 vs. >=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.||
1679925|NCT01247324|3090587|Superiority or Other (legacy)||Adjusted rate ratio|0.058|||<|0.0001||95.0|0.032|0.104|||Negative Binomial Model||Adjusted by baseline T1 Gd lesion (present or not), baseline EDSS (<4.0 vs. >=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.||
1679926|NCT01247324|3090588|Superiority or Other (legacy)||Hazard Ratio (HR)|0.57|||=|0|2-Sided|95.0|0.37|0.9|||Log Rank|||Time to onset CDP at week 12|
1679927|NCT01247324|3090589|Superiority or Other (legacy)||Rate Ratio|0.536|||<|0.0001|2-Sided|95.0|0.4|0.719|||Negative Binomial Model||Rate ratio was calculated as Ocrelizumab ARR/Interferon beta-1a 44 mcg SC ARR.|Adjusted by Geographical Region (US vs. Rest of World) and baseline EDSS (<4.0 vs. >=4.0).|
1679928|NCT01247298|3090591|Other||Kaplan Meier Estimate|82.0|||||2-Sided||||||||Kaplan Meier Estimates of Progression Free Survival (PFS)||
1679929|NCT01247285|3090595|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.05|||||2-Sided|90.0|94.76|107.77|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1679930|NCT01247285|3090596|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.64|||||2-Sided|90.0|99.97|111.56|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1679931|NCT01247285|3090597|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.88|||||2-Sided|90.0|98.53|111.64|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1679932|NCT01247285|3090598|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.77|||||2-Sided|90.0|93.53|108.56|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1679933|NCT01247285|3090599|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|100.69|||||2-Sided|90.0|92.9|109.14|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1679956|NCT01246895|3090634|Superiority or Other|||||||0.474||||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Pain|
1680000|NCT01245439|3090741|Superiority or Other||||||<|0.007|||||||Wilcoxon Signed Rank test.|||PT assessment Visit 6 to Visit 7|
1679934|NCT01247285|3090600|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.81|||||2-Sided|90.0|97.37|119.38|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1679935|NCT01247272|3090601|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.83|||||2-Sided|90.0|101.27|110.61|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1679936|NCT01247272|3090602|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.8|||||2-Sided|90.0|101.66|110.12|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1679937|NCT01247272|3090603|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.57|||||2-Sided|90.0|99.54|107.76|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1679938|NCT01247272|3090604|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.99|||||2-Sided|90.0|102.09|112.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1679939|NCT01247272|3090605|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.78|||||2-Sided|90.0|102.18|113.69|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1679940|NCT01247272|3090606|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|113.36|||||2-Sided|90.0|108.03|118.96|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1679941|NCT01247064|3090611|Superiority or Other|||||||0.62|||||||Chi-squared||||
1679942|NCT01247064|3090612|Superiority or Other|||||||0.36|||||||t-test, 2 sided||||
1679943|NCT01247064|3090613|Superiority or Other|||||||0.02|||||||t-test, 2 sided||||
1679944|NCT01247064|3090614|Superiority or Other|||||||0.86|||||||Chi-squared||||
1679945|NCT01247064|3090615|Superiority or Other|||||||0.01|||||||t-test, 2 sided||||
1679946|NCT01246973|3090623|Superiority or Other|||||||0.3504|||||||Chi-squared||||
1679947|NCT01246973|3090624|Superiority or Other|||||||0.6555|||||||F-test||||
1679948|NCT01246960|3090627|Superiority or Other||Hazard Ratio (HR)|0.88||||0.516|2-Sided|95.0|0.59|1.3|||Stratified Log Rank||||
1679949|NCT01246960|3090630|Superiority or Other||Hazard Ratio (HR)|1.08||||0.712|2-Sided|95.0|0.73|1.58|||Stratified Log Rank||||
1679950|NCT01246960|3090631|Superiority or Other||Hazard Ratio (HR)|0.98||||0.886|2-Sided|95.0|0.69|1.37|||Stratified Log Rank||||
1679951|NCT01246895|3090632|Superiority or Other|||||||0.125||||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||SF-36 v2 Mental component|
1679952|NCT01246895|3090632|Superiority or Other|||||||0.478||||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||SF-36 v2 Physical component|
1679953|NCT01246895|3090633|Superiority or Other|||||||0.01|||||||Physical count||||
1679954|NCT01246895|3090634|Superiority or Other|||||||0.326||||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Physical function|
1679955|NCT01246895|3090634|Superiority or Other|||||||0.236||||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.||WOMAC subscale - Stiffness|
1679957|NCT01246895|3090635|Superiority or Other|||||||0.026||||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|||
1679958|NCT01246895|3090636|Superiority or Other|||||||0.017||||||P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|general estimating equations (GEE)|P-values were obtained using general estimating equations (GEE) for longitudinal analysis of repeated correlated measures.|||
1679959|NCT01246401|3090656|Superiority|||||||0.03962|||||||Chi-squared||||
1679960|NCT01246401|3090661|Superiority|||||||0.03||||||Wilcoxon one sided|Wilcoxon (Mann-Whitney)||||
1679961|NCT01246401|3090663|Superiority|||||||0.087|||||||Welch's T Test||||
1679962|NCT01246401|3090664|Superiority|||||||0.431|||||||Welch's T Test||||
1679963|NCT01246349|3090665|Superiority or Other||Mean Difference (Final Values)|0.183|Standard Error of the Mean|1.265||0.88|2-Sided|95.0|-2.301|2.668|||Regression, Linear|||"Based on previous research , baseline CDSS means were expected between 5 - 6.5 with a SD of 3 - 4. It was hypothesized that an attributable effect of 1.5 would be detected.~Published results comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the absolute attributable effect of intervention (i.e., the difference in self-efficacy [CDSS] change between the treatment and control groups from baseline to a 6 month follow-up)."|
1679964|NCT01246349|3090667|Superiority or Other|||||||0.09|||||||Regression, Linear|||Results published comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the attributable effect of intervention (i.e., the difference in waist circumference change between the treatment and control groups from baseline to a 6-month follow-up).|
1679965|NCT01246349|3090668|Superiority or Other|||||||0.56|||||||Regression, Linear|||Results published comprise baseline and follow-up BMI z-score means and standard deviations for both the MI and control groups (reported above), as well as the attributable effect of intervention (i.e., the difference in BMI change between the treatment and control groups from baseline to a 6-month follow-up)|
1679966|NCT01246349|3090669|Superiority or Other||Mean Difference (Final Values)|8.616|Standard Error of the Mean|7.373||0.24|2-Sided|95.0|-5.871|23.103|||Regression, Linear|||Published results comprise baseline and follow-up means and standard deviations for both the MI and control group (reported above), as well as the absolute attributable effect of intervention (i.e., the difference in self-efficacy [WEL] change between the treatment and control groups from baseline to a 6 month follow-up).|
1679967|NCT01245751|3090710|Superiority or Other||Geometric mean fold rise|1.54|||<|0.001|2-Sided|95.0|1.44|1.66||The alpha threshold for statistical significance is 0.025 (1-sided)|Longitudinal regression model|The analyzed GMFR, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age||A booster dose induces a statistically acceptable VZV antibody response if the lower bound of the 95% confidence interval is >1.0.|
1679968|NCT01245751|3090711|Non-Inferiority or Equivalence|Week 6 GMT value for Group 1 is statistically non-inferior to Group 2 for the prespecified clinically relevant 1.5-fold ratio if the lower bound of the 95% confidence interval for the GMT ratio is >0.67|GMT Ratio|1.05|||<|0.001|2-Sided|95.0|0.97|1.15||The alpha threshold for statistical significance is 0.025 (1-sided)|Longitudinal regression model|The analyzed GMT ratio, 95% confidence interval, and P-value were based on a longitudinal regression model adjusting for age and vaccination group||Week 6 analysis|
1679969|NCT01245699|3090727|Superiority|||||||0.65|||||||Kruskal-Wallis||||
1679970|NCT01245699|3090728|Superiority|||||||0.1|||||||Kruskal-Wallis||||
1679971|NCT01245699|3090729|Superiority||||||<|0.001|||||||Kruskal-Wallis||||
1679972|NCT01245699|3090730|Superiority||||||<|0.001|||||||Kruskal-Wallis||||
1679973|NCT01245647|3090733|Superiority or Other|||||||0.67|||||||t-test, 2 sided||||
1679974|NCT01245647|3090734|Superiority or Other|||||||0.12||||||no significant difference by Fisher exact test|Fisher Exact||||
1679975|NCT01245647|3090735|Superiority or Other|||||||0.46|||||||Fisher Exact||||
1679976|NCT01245647|3090736|Superiority or Other|||||||1|||||||Fisher Exact||||
1679977|NCT01245647|3090737|Superiority or Other|||||||0.82|||||||t-test, 2 sided||||
1679978|NCT01245439|3090739|Superiority or Other|||||||0.224|||||||Wilcoxon Signed Rank test.|||Change between Visit 7 to Visit 8|
1679979|NCT01245439|3090739|Superiority or Other|||||||0.722|||||||Wilcoxon Signed Rank test.|||Change between Visit 6 to Visit 7|
1679980|NCT01245439|3090739|Superiority or Other|||||||0.349|||||||Wilcoxon Signed Rank test.|||Change between Visit 5 to Visit 6|
1679981|NCT01245439|3090739|Superiority or Other|||||||0.078|||||||Wilcoxon Signed Rank test.|||Change between Visit 4 to Visit 5|
1679982|NCT01245439|3090739|Superiority or Other|||||||0.002|||||||Wilcoxon Signed Rank test.|||Change between Visit 3 to Visit 4|
1679983|NCT01245439|3090739|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 3|
1679984|NCT01245439|3090740|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 8|
1679985|NCT01245439|3090740|Superiority or Other||||||<|0.104|||||||Wilcoxon Signed Rank test.|||Change between Visit 7 to Visit 8|
1679986|NCT01245439|3090740|Superiority or Other||||||<|0.002|||||||Wilcoxon Signed Rank test.|||Change between Visit 6 to Visit 7|
1679987|NCT01245439|3090740|Superiority or Other||||||<|0.138|||||||Wilcoxon Signed Rank test.|||Change between Visit 5 to Visit 6|
1679988|NCT01245439|3090740|Superiority or Other||||||<|0.254|||||||Wilcoxon Signed Rank test.|||Change between Visit 4 to Visit 5|
1679989|NCT01245439|3090740|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change between Visit 3 to Visit 4|
1679990|NCT01245439|3090740|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change between Visit 2 to Visit 3|
1679991|NCT01245439|3090741|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||IN assessment Visit 2 to Visit 8|
1679992|NCT01245439|3090741|Superiority or Other||||||<|0.02|||||||Wilcoxon Signed Rank test.|||IN assessment Visit 7 to Visit 8|
1680001|NCT01245439|3090741|Superiority or Other||||||<|0.119|||||||Wilcoxon Signed Rank test.|||PT assessment Visit 5 to Visit 6|
1680002|NCT01245439|3090741|Superiority or Other||||||<|0.075|||||||Wilcoxon Signed Rank test.|||PT assessment Visit 4 to Visit 5|
1680003|NCT01245439|3090741|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||PT assessment Visit 3 to Visit 4|
1680004|NCT01245439|3090741|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||PT assessment Visit 2 to Visit 3|
1680005|NCT01245439|3090742|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 2 to Visit 8|
1680006|NCT01245439|3090742|Superiority or Other||||||<|0.048|||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 7 to Visit 8|
1680007|NCT01245439|3090742|Superiority or Other||||||<|0.744|||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 6 to Visit 7|
1680008|NCT01245439|3090742|Superiority or Other||||||<|0.518|||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 5 to Visit 6|
1680009|NCT01245439|3090742|Superiority or Other||||||<|0.374|||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 4 to Visit 5|
1680010|NCT01245439|3090742|Superiority or Other||||||<|0.002|||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 3 to Visit 4|
1680011|NCT01245439|3090742|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 2 to Visit 3|
1680012|NCT01245439|3090742|Superiority or Other||||||<|0.792|||||||Wilcoxon Signed Rank test.|||Change in Swollen Joints from Visit 1 to Visit 2|
1680013|NCT01245439|3090742|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 2 to Visit 8|
1680014|NCT01245439|3090742|Superiority or Other||||||<|0.093|||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 7 to Visit 8|
1680015|NCT01245439|3090742|Superiority or Other||||||<|0.827|||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 6 to Visit7|
1680016|NCT01245439|3090742|Superiority or Other||||||<|0.003|||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 5 to Visit 6|
1680017|NCT01245439|3090742|Superiority or Other||||||<|0.021|||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 4 to Visit 5|
1680018|NCT01245439|3090742|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 3 to Visit 4|
1680019|NCT01245439|3090742|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints from Visit 2 to Visit 3|
1680020|NCT01245439|3090742|Superiority or Other||||||<|0.41|||||||Wilcoxon Signed Rank test.|||Change in Sensitive Joints Visit 1 to Visit 2|
1680021|NCT01245439|3090743|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.||||
1680022|NCT01245439|3090743|Superiority or Other||||||<|0.779|||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8|
1680023|NCT01245439|3090743|Superiority or Other||||||<|0.126|||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7|
1680024|NCT01245439|3090743|Superiority or Other||||||<|0.264|||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6|
1680025|NCT01245439|3090743|Superiority or Other||||||<|0.566|||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5|
1680026|NCT01245439|3090743|Superiority or Other||||||<|0.005|||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4|
1680027|NCT01245439|3090743|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 3|
1680028|NCT01245439|3090743|Superiority or Other||||||<|0.981|||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2|
1680029|NCT01245439|3090744|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 8|
1680030|NCT01245439|3090744|Superiority or Other||||||<|0.064|||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8|
1680031|NCT01245439|3090744|Superiority or Other||||||<|0.038|||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7|
1680032|NCT01245439|3090744|Superiority or Other||||||<|0.064|||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6|
1680033|NCT01245439|3090744|Superiority or Other||||||<|0.514|||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5|
1680034|NCT01245439|3090744|Superiority or Other||||||<|0.053|||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4|
1680035|NCT01245439|3090744|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 3|
1680036|NCT01245439|3090744|Superiority or Other||||||<|0.169|||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2|
1680037|NCT01245439|3090747|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to Visit 8|
1680038|NCT01245439|3090747|Superiority or Other||||||<|0.217|||||||Wilcoxon Signed Rank test.|||Change from Visit 7 to Visit 8|
1680039|NCT01245439|3090747|Superiority or Other||||||<|0.133|||||||Wilcoxon Signed Rank test.|||Change from Visit 6 to Visit 7|
1680040|NCT01245439|3090747|Superiority or Other||||||<|0.165|||||||Wilcoxon Signed Rank test.|||Change from Visit 5 to Visit 6|
1680041|NCT01245439|3090747|Superiority or Other||||||<|0.05|||||||Wilcoxon Signed Rank test.|||Change from Visit 4 to Visit 5|
1680042|NCT01245439|3090747|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change from Visit 3 to Visit 4|
1680043|NCT01245439|3090747|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank test.|||Change from Visit 2 to 3|
1680044|NCT01245439|3090747|Superiority or Other||||||<|0.929|||||||Wilcoxon Signed Rank test.|||Change from Visit 1 to Visit 2|
1680045|NCT01245270|3090842|Superiority or Other|||||||0.028||||||For incremental area under the curve (AUCi), only the extent of interpolated values above baseline contributed. Values obtained following the control and extract capsules were compared by paired t-tests.|t-test, 2 sided||||
1680046|NCT01245270|3090843|Superiority or Other|||||||0.003||||||"For the incremental area under the curve (AUCi), only the extent of interpolated values above baseline contributed.~Values obtained following the control and extract capsules were compared by paired t-tests."|t-test, 2 sided||||
1680047|NCT01245140|3090862|Superiority or Other|||||||0.1667||||||mPASI 75 response|Fisher Exact||||
1680048|NCT01245140|3090862|Superiority or Other|||||||0.1667||||||mPASI 50 response|Fisher Exact||||
1680049|NCT01245140|3090863|Superiority or Other||Least squared estimation|49.4927||||0.2358|2-Sided|95.0|-49.083|148.07|||ANCOVA||||
1680050|NCT01245140|3090864|Superiority or Other|||||||0.12||||||Relative change in mPASI score: BL to Last Visit|Wilcoxon test: Exact Test||||
1680051|NCT01245140|3090865|Superiority or Other|||||||0.51||||||Change in Total Pustule Count: BL to Last Visit|Wilcoxon test: Exact Test||||
1680052|NCT01245140|3090867|Superiority or Other|||||||0.6595||||||PPPASI 75 response|Fisher Exact||||
1680053|NCT01245140|3090867|Superiority or Other|||||||0.4564||||||PPPASI 50 response|Fisher Exact||||
1680054|NCT01245140|3090868|Superiority or Other||Mean Difference (Net)|0.5731||||0.9705|2-Sided|95.0|-30.9738|32.12|||ANCOVA||||
1680055|NCT01245062|3090887|Superiority||Hazard Ratio (HR)|0.41|||<|0.0001|2-Sided|95.0|0.29|0.6||P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|Log Rank||Independent Review PFS. HR <1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.||
1680056|NCT01245062|3090887|Superiority||Hazard Ratio (HR)|0.44|||<|0.0001|2-Sided|95.0|0.31|0.64||P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.|Log Rank||Investigator-Assessed PFS. HR <1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.||
1680057|NCT01245049|3090908|Non-Inferiority|Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups’ (Repevax Group divided by Boostrix-Polio Group) ≤ 2.|Difference in adjusted GMT ratio|1.3|||||2-Sided|95.0|0.93|1.84||||||Immune response difference to anti-Polio 3 antigen|
1680058|NCT01245049|3090908|Non-Inferiority|Criterion for evaluation of the corresponding objective: UL of the 95% CI on the GMT ratio for the groups’ (Repevax Group divided by Boostrix-Polio Group) ≤ 2.|Difference in adjusted GMT ratio|0.78|||||2-Sided|95.0|0.54|1.12||||||Immune response difference to anti-Polio 2 antigen|
1680059|NCT01245049|3090908|Non-Inferiority|Criterion for evaluation of the corresponding objective: Upper limit (UL) of the 95% confidence interval (CI) on the GMT ratio for the groups’ (Repevax Group divided by Boostrix-Polio Group) was lower than or equal to (≤) 2.|Difference in adjusted GMT ratio|0.91|||||2-Sided|95.0|0.65|1.28||||||Immune response difference to anti-Polio 1 antigen|
1680060|NCT01245049|3090910|Non-Inferiority|To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to tetanus, standardized asymptotic 95% CI for the groups’ difference [Repevax Group minus Boostrix Polio Group] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups’ difference in booster response rate ≤10%.|Percentage difference|1.7|||||2-Sided|95.0|-2.43|4.9||||||Non-inferiority in terms of booster response to T|
1680061|NCT01245049|3090910|Non-Inferiority|To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to diphtheria, standardized asymptotic 95% CI for the groups’difference [Repevax Group minus Boostrix Polio Group] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups’ difference in booster response rate ≤10%.|Percentage difference|0.56|||||2-Sided|95.0|-3.55|3.14||||||Non-inferiority in terms of booster response to D|
1680062|NCT01244893|3090943|Non-Inferiority or Equivalence|This study uses -0.05 LogMAR as the non-inferiority margin.|Mean Difference (Final Values)|0.005|Standard Error of the Mean|0.003|||2-Sided|95.0|-0.00092|0.01045|||||The mean difference is calculated as the test lens - control lens.|"Ho: after time period (6-8 days of lens wear), the test lens - control lens will be greater than or equal to the non-inferiority margin specified .~Ha: after time period, test-control will be less than the margin specified concluding that the test lens will be inferior to control lens in terms of LogMAR scale"|
1680063|NCT01244815|3090953|Superiority or Other||Difference in LS Means|0.25||||0.044|2-Sided|95.0|0.01|0.49|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo||
1680064|NCT01244815|3090953|Superiority or Other||Difference in LS Means|0.18||||0.135|2-Sided|95.0|-0.06|0.41|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo||
1680065|NCT01244815|3090953|Superiority or Other||Difference in LS Means|0.39||||0.001|2-Sided|95.0|0.15|0.62|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo||
1680066|NCT01244815|3090954|Superiority or Other||Difference in LS Means|2.78||||0.018|2-Sided|95.0|0.48|5.08|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo||
1680067|NCT01244815|3090954|Superiority or Other||Difference in LS Means|1.35||||0.239|2-Sided|95.0|-0.9|3.59|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo||
1680068|NCT01244815|3090954|Superiority or Other||Difference in LS Means|2.24||||0.05|2-Sided|95.0|0.0|4.48|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo||
1680069|NCT01244815|3090955|Superiority or Other||Difference in LS Means|5.11|||<|0.001|2-Sided|95.0|2.31|7.91|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo||
1680070|NCT01244815|3090955|Superiority or Other||Difference in LS Means|6.95|||<|0.001|2-Sided|95.0|4.22|9.68|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo||
1680071|NCT01244815|3090955|Superiority or Other||Difference in LS Means|4.29|||<|0.002|2-Sided|95.0|1.56|7.02|||ANCOVA|Model included terms of (pooled) site, treatment and baseline|Estimate is asenapine versus placebo||
1680072|NCT01244815|3090956|Superiority or Other||Difference in LS Means|-1.28||||0.189|2-Sided|95.0|-3.2|0.63|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680168|NCT01244061|3091033|Superiority or Other||Odds Ratio (OR)|2.94|||<|0.0001|2-Sided|95.0|1.86|4.64||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 24 assessment|
1680073|NCT01244815|3090956|Superiority or Other||Difference in LS Means|-2.19||||0.023|2-Sided|95.0|-4.08|-0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680074|NCT01244815|3090956|Superiority or Other||Difference in LS Means|-1.44||||0.135|2-Sided|95.0|-3.33|0.45|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680075|NCT01244815|3090957|Superiority or Other||Difference in LS Means|-1.44||||0.121|2-Sided|95.0|-3.27|0.38|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680076|NCT01244815|3090957|Superiority or Other||Difference in LS Means|-2.44||||0.009|2-Sided|95.0|-4.26|-0.63|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680077|NCT01244815|3090957|Superiority or Other||Difference in LS Means|-0.79||||0.395|2-Sided|95.0|-2.62|1.04|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680078|NCT01244815|3090958|Superiority or Other||Difference in LS Means|-2.16||||0.017|2-Sided|95.0|-3.93|-0.38|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680079|NCT01244815|3090958|Superiority or Other||Difference in LS Means|-2.17||||0.017|2-Sided|95.0|-3.95|-0.39|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680080|NCT01244815|3090958|Superiority or Other||Difference in LS Means|-2.61||||0.004|2-Sided|95.0|-4.38|-0.83|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680081|NCT01244815|3090959|Superiority or Other||Difference in LS Means|-0.2||||0.139|2-Sided|95.0|-0.46|0.06|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680082|NCT01244815|3090959|Superiority or Other||Difference in LS Means|-0.34||||0.01|2-Sided|95.0|-0.6|-0.08|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680083|NCT01244815|3090959|Superiority or Other||Difference in LS Means|-0.23||||0.079|2-Sided|95.0|-0.49|0.03|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680084|NCT01244815|3090960|Superiority or Other||Difference in LS Means|-0.16||||0.211|2-Sided|95.0|-0.4|0.09|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680085|NCT01244815|3090960|Superiority or Other||Difference in LS Means|-0.19||||0.131|2-Sided|95.0|-0.43|0.06|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680086|NCT01244815|3090960|Superiority or Other||Difference in LS Means|-0.08||||0.506|2-Sided|95.0|-0.33|0.16|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680087|NCT01244815|3090961|Superiority or Other||Difference in LS Means|-0.15||||0.178|2-Sided|95.0|-0.36|0.07|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680088|NCT01244815|3090961|Superiority or Other||Difference in LS Means|-0.18||||0.094|2-Sided|95.0|-0.4|0.03|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680430|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|255.421||||0.0018|2-Sided|95.0|7.87|8290.22|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680089|NCT01244815|3090961|Superiority or Other||Difference in LS Means|-0.21||||0.053|2-Sided|95.0|-0.42|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680090|NCT01244815|3090962|Superiority or Other||Difference in LS Means|0.07||||0.556|2-Sided|95.0|-0.15|0.28|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680091|NCT01244815|3090962|Superiority or Other||Difference in LS Means|-0.03||||0.811|2-Sided|95.0|-0.24|0.19|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680092|NCT01244815|3090962|Superiority or Other||Difference in LS Means|-0.07||||0.536|2-Sided|95.0|-0.28|0.15|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680093|NCT01244815|3090963|Superiority or Other||Difference in LS Means|-0.74|||<|0.001|2-Sided|95.0|-1.03|-0.45|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680094|NCT01244815|3090963|Superiority or Other||Difference in LS Means|-0.75|||<|0.001|2-Sided|95.0|-1.04|-0.46|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680095|NCT01244815|3090963|Superiority or Other||Difference in LS Means|-0.61|||<|0.001|2-Sided|95.0|-0.9|-0.32|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680096|NCT01244815|3090964|Superiority or Other||Difference in LS Means|-0.61|||<|0.001|2-Sided|95.0|-0.88|-0.35|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680097|NCT01244815|3090964|Superiority or Other||Difference in LS Means|-0.63|||<|0.001|2-Sided|95.0|-0.89|-0.36|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680098|NCT01244815|3090964|Superiority or Other||Difference in LS Means|-0.34|||<|0.011|2-Sided|95.0|-0.61|-0.08|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680099|NCT01244815|3090965|Superiority or Other||Difference in LS Means|-0.44|||<|0.001|2-Sided|95.0|-0.67|-0.21|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680100|NCT01244815|3090965|Superiority or Other||Difference in LS Means|-0.35|||<|0.003|2-Sided|95.0|-0.59|-0.12|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680101|NCT01244815|3090965|Superiority or Other||Difference in LS Means|-0.33|||<|0.006|2-Sided|95.0|-0.56|-0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680102|NCT01244815|3090966|Superiority or Other||Difference in LS Means|-0.21||||0.039|2-Sided|95.0|-0.42|-0.01|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680103|NCT01244815|3090966|Superiority or Other||Difference in LS Means|-0.17||||0.107|2-Sided|95.0|-0.37|0.04|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680104|NCT01244815|3090966|Superiority or Other||Difference in LS Means|-0.25||||0.014|2-Sided|95.0|-0.45|-0.05|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680431|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|190.835||||0.0025|2-Sided|95.0|6.34|5743.12|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680105|NCT01244815|3090967|Superiority or Other||Odds Ratio (OR)|2.9|||<|0.001||95.0|1.6|5.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)|
1680106|NCT01244815|3090967|Superiority or Other||Odds Ratio (OR)|3.2|||<|0.001|2-Sided|95.0|1.7|5.8||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)|
1680107|NCT01244815|3090967|Superiority or Other||Odds Ratio (OR)|1.9|||<|0.042|2-Sided|95.0|1.0|3.4||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 21 (LOCF)|
1680108|NCT01244815|3090967|Superiority or Other||Odds Ratio (OR)|4.1|||<|0.001|2-Sided|95.0|2.2|7.6|||Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)|
1680109|NCT01244815|3090967|Superiority or Other||Odds Ratio (OR)|4.1|||<|0.001|2-Sided|95.0|2.2|7.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)|
1680110|NCT01244815|3090967|Superiority or Other||Odds Ratio (OR)|2.2|||<|0.018|2-Sided|95.0|1.1|4.1||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 14 (LOCF)|
1680111|NCT01244815|3090967|Superiority or Other||Odds Ratio (OR)|3.6|||<|0.001|2-Sided|95.0|1.8|7.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)|
1680112|NCT01244815|3090967|Superiority or Other||Odds Ratio (OR)|2.8|||<|0.005|2-Sided|95.0|1.4|5.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)|
1680113|NCT01244815|3090967|Superiority or Other||Odds Ratio (OR)|2.9|||<|0.003|2-Sided|95.0|1.4|5.9||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 7 (LOCF)|
1680114|NCT01244815|3090967|Superiority or Other||Odds Ratio (OR)|2.1|||<|0.129|2-Sided|95.0|0.8|5.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)|
1680115|NCT01244815|3090967|Superiority or Other||Odds Ratio (OR)|3.4|||<|0.008|2-Sided|95.0|1.4|8.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)|
1680116|NCT01244815|3090967|Superiority or Other||Odds Ratio (OR)|3.0|||<|0.018|2-Sided|95.0|1.2|7.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of treatment and baseline Y-MRS total score|OR was adjusted for baseline. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total Y-MRS 50% response.|Analysis is for asenapine versus placebo on Day 4 (LOCF)|
1680117|NCT01244815|3090968|Superiority or Other||Difference in LS Means|-0.7|||<|0.001|2-Sided|95.0|-1.0|-0.4||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680118|NCT01244815|3090968|Superiority or Other||Difference in LS Means|-0.7|||<|0.001|2-Sided|95.0|-0.9|-0.4||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680119|NCT01244815|3090968|Superiority or Other||Difference in LS Means|-0.6|||<|0.001|2-Sided|95.0|-0.9|-0.3||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680169|NCT01244061|3091033|Superiority or Other||Odds Ratio (OR)|7.85|||<|0.0001|2-Sided|95.0|4.92|12.51||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 12 assessment|
1680120|NCT01244815|3090969|Superiority or Other||t-statistic|-5.49|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 7 (Placebo<2.5 mg<5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 7. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.|
1680121|NCT01244815|3090969|Superiority or Other||t-statistic|-5.07|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 6 (Placebo<2.5 mg=5.0 mg<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 6. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.|
1680122|NCT01244815|3090969|Superiority or Other||t-statistic|-4.64|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 5 (Placebo=2.5 mg<5.0 mg<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 5. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.|
1680123|NCT01244815|3090969|Superiority or Other||t-statistic|-5.28|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 4 (Placebo<2.5 mg<5.0 mg<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 4. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.|
1680124|NCT01244815|3090969|Superiority or Other||t-statistic|-3.4|||<|0.0021||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 3 (Placebo=2.5 mg=5.0 mg<10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 3. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.|
1680125|NCT01244815|3090969|Superiority or Other||t-statistic|-4.87|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 2 (Placebo=2.5 mg<5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 2. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.|
1680126|NCT01244815|3090969|Superiority or Other||t-statistic|-4.92|||<|0.0001||||||p-value (adjusted to control Type I error in multiple testing) for dose-response pattern 1 (Placebo<2.5 mg=5.0 mg=10.0 mg)|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|t-statistic associated with the contrast of the MMRM model for dose-response pattern 1. Lower value indicates pattern provides better fit to data.|Investigation of dose-response relationship of change from baseline to Day 21 in Y-MRS total score was a Secondary study endpoint. Multiple contrast testing using MMRM model (FAS population) was used to evaluate 7 pre-defined dose-response patterns.|
1680127|NCT01244815|3090969|Superiority or Other||Difference in LS Means|-6.2|||<|0.001|2-Sided|95.0|-8.6|-3.8||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680128|NCT01244815|3090969|Superiority or Other||Difference in LS Means|-5.3|||<|0.001|2-Sided|95.0|-7.7|-2.9||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680129|NCT01244815|3090969|Superiority or Other||Difference in Least Squares (LS) Means|-3.2|||<|0.008|2-Sided|95.0|-5.6|-0.8||p-value is adjusted by Hochberg's method for testing three asenapine groups versus the placebo group|Mixed Model for Repeated Measures (MMRM)|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 98, asenapine 2.5 mg – 101, asenapine 5.0 mg – 98, asenapine 10.0 mg – 98)|
1680130|NCT01244516|3090992|Non-Inferiority or Equivalence|The non-inferiority margin is set at > 0.75. Superiority is concluded is the 97.4% CL > 1.|Odds Ratio (OR)|1.66|||||2-Sided|97.4|1.14|2.44||||||The comparison is between galyfilcon A (AAHP) and comfilcon A (BIO) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/BIO). Ha: OR > 1 for (AAHP/BIO).|
1680424|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|622.309||||0.002|2-Sided|95.0|10.51|36846.03|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680131|NCT01244516|3090992|Non-Inferiority or Equivalence|The non-inferiority margin is set at > 0.75. Superiority is concluded is the 97.4% CL > 1.|Odds Ratio (OR)|1.66|||||2-Sided|97.4|1.14|2.44|||||The direction of comparison is AAHP/AOA.|The comparison is between galyfilcon A (AAHP) and lotrafilcon B (AOA) for comparing proportions of those with corneal staining and those without. Ho: OR = 1 for (AAHP/AOA). Ha: OR > 1 for (AAHP/AOA).|
1680132|NCT01244516|3090993|Non-Inferiority or Equivalence|The non-inferiority margin is set at -5.|Mean Difference (Final Values)|0.42|Standard Error of the Mean|2.79|||2-Sided|97.4|-5.96|6.79|||||The direction of comparison is AAHP - BIO.|This comparison is between galyfilcon A and comfilcon A. Ho: gayfilcon A- comfilcon A <= -5. Ha: galyfilcon A- comfilcon A> -5.|
1680133|NCT01244516|3090993|Non-Inferiority or Equivalence|The non-inferiority margin is set at -5.|Mean Difference (Final Values)|0.39|Standard Error of the Mean|2.83|||2-Sided|97.4|-5.91|6.7|||||The direction of comparison is AAHP - AOA.|This comparison is between galyfilcon and lotrafilcon B. Ho: galyfilcon A -lotrafilcon B <= -5. Ha: galyfilcon A - lotrafilcon B > -5.|
1680134|NCT01244490|3090999|Superiority or Other||Difference in Least Squares Mean|-0.039||||0.315|2-Sided|95.0|-0.115|0.037||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680135|NCT01244490|3090999|Superiority or Other||Difference in Least Squares Mean|-0.056||||0.139|2-Sided|95.0|-0.131|0.018||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680136|NCT01244490|3091000|Superiority or Other||Difference in Least Squares Mean|-0.111||||0.124|2-Sided|95.0|-0.253|0.031||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680137|NCT01244490|3091000|Superiority or Other||Difference in Least Squares Mean|-0.233||||0.001|2-Sided|95.0|-0.374|-0.092||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680138|NCT01244490|3091001|Superiority or Other||Difference in Least Squares Mean|-0.078||||0.288|2-Sided|95.0|-0.222|0.066||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680139|NCT01244490|3091001|Superiority or Other||Difference in Least Squares Mean|-0.049||||0.5|2-Sided|95.0|-0.191|0.094||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680140|NCT01244490|3091002|Superiority or Other||Difference in Least Squares Mean|-0.067||||0.242|2-Sided|95.0|-0.18|0.046||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680141|NCT01244490|3091002|Superiority or Other||Difference in Least Squares Mean|-0.094||||0.096|2-Sided|95.0|-0.204|0.017||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680142|NCT01244490|3091003|Superiority or Other||Difference in Least Squares Mean|-0.181||||0.009|2-Sided|95.0|-0.317|-0.045||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680143|NCT01244490|3091003|Superiority or Other||Diiference in Least Squares Mean|-0.229|||<|0.001|2-Sided|95.0|-0.364|-0.094||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680144|NCT01244490|3091004|Superiority or Other||Difference in Least Squares Mean|-0.125||||0.231|2-Sided|95.0|-0.331|0.08||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680145|NCT01244490|3091004|Superiority or Other||Difference in Least Squares Mean|-0.211||||0.043|2-Sided|95.0|-0.416|-0.007||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680146|NCT01244490|3091005|Superiority or Other||Mean Difference (Final Values)|-0.104||||0.048|2-Sided|95.0|-0.207|-0.001||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680147|NCT01244490|3091005|Superiority or Other||Mean Difference (Final Values)|-0.165||||0.001|2-Sided|95.0|-0.266|-0.064||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1680148|NCT01244490|3091007|Superiority or Other|||||||0.196||||||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel||||
1680149|NCT01244490|3091007|Superiority or Other||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel||||
1680150|NCT01244490|3091008|Superiority or Other||Difference in Least Squares Mean|-0.09||||0.242|2-Sided|95.0|-0.241|0.061|||ANCOVA||||
1680151|NCT01244490|3091008|Superiority or Other||Difference in Least Squares Mean|-0.209||||0.006|2-Sided|95.0|-0.358|-0.059|||ANCOVA||||
1680152|NCT01244490|3091009|Superiority or Other||Difference in Least Squares Mean|-0.162||||0.026|2-Sided|95.0|-0.305|-0.019|||ANCOVA||||
1680153|NCT01244490|3091009|Superiority or Other||Difference in Least Squares Mean|-0.217||||0.003|2-Sided|95.0|-0.358|-0.076|||ANCOVA||||
1680154|NCT01244490|3091010|Superiority or Other||Difference in Percentage Improvement|12.1||||0.024|2-Sided|95.0|-0.9|25.1|||Cochran-Mantel-Haenszel||||
1680155|NCT01244490|3091010|Superiority or Other||Difference in Percentage Improvement|23.7|||<|0.001|2-Sided|95.0|11.1|36.4|||Cochran-Mantel-Haenszel||||
1680156|NCT01244490|3091011|Superiority or Other||Difference in Least Squares Mean|-3.8||||0.017|2-Sided|95.0|-6.8|-0.7|||ANCOVA||||
1680157|NCT01244490|3091011|Superiority or Other||Difference in Least Squares Mean|-8.9|||<|0.001|2-Sided|95.0|-11.9|-5.8|||ANCOVA||||
1680158|NCT01244425|3091021|Superiority or Other|||||||0.808|||||||likelihood ratio chi-square test||||
1680159|NCT01244425|3091022|Superiority or Other|||||||0.237|||||||likelihood ratio chi-square test||||
1680160|NCT01244425|3091023|Superiority or Other|||||||0.293|||||||likelihood ratio chi-square test||||
1680161|NCT01244425|3091024|Superiority or Other|||||||0.017|||||||likelihood ratio chi-square test||||
1680162|NCT01244425|3091025|Superiority or Other|||||||0.028|||||||likelihood ratio chi-square test||||
1680163|NCT01244425|3091026|Superiority or Other||||||<|0.001|||||||likelihood ratio chi-square test||||
1680164|NCT01244425|3091027|Superiority or Other||||||<|0.001|||||||likelihood-ratio chi square test||||
1680165|NCT01244126|3091031|Superiority or Other||Kruskall Wallis ANOVA|0.34||||0.34||95.0|||||Kruskal-Wallis|||Kruskall Wallis test|
1680166|NCT01244126|3091032|Superiority or Other||Kruskall Wallis ANOVA by ranks|0.21|Standard Deviation|3.0||0.21|2-Sided|95.0|||||Kruskal-Wallis|||The primary outcome of the study was the maximum postoperative FLACC pain score.|
1680167|NCT01244061|3091033|Superiority or Other||Odds Ratio (OR)|3.06|||<|0.0001|2-Sided|95.0|1.88|4.97||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||Week 52 assessment|
1680522|NCT01241552|3091376|Superiority or Other||Percentage Difference|-16.2|||||2-Sided|95.0|-24.5|-7.7|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC||
1680170|NCT01244061|3091034|Superiority or Other||Odds Ratio (OR)|5.83|||<|0.0001|2-Sided|95.0|3.25|10.44||The statistical test was two-sided and at a 0.05 level of significance. No adjustment was made for the analysis of multiple secondary endpoints.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.|||
1680171|NCT01244061|3091035|Superiority or Other||Odds Ratio (OR)|9.0|||<|0.0001|2-Sided|95.0|3.97|20.41||Statistical significance was declared for each hypothesis in the order above until a p-value >0.05 was obtained, at which point the hypothesis was declared to be not statistically significant.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||The sample size was sufficient to achieve 80% power for the treatment comparison in the key secondary end point for an odds ratio of 2.55 with a placebo abstinence rate of 6% and varenicline abstinence rate of 14%. The intent of the key secondary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation from Week 9 to the end of non-treatment follow up period at Week 52.|
1680172|NCT01244061|3091036|Superiority or Other||Odds Ratio (OR)|7.08|||<|0.0001|2-Sided|95.0|4.34|11.55||The statistical significance was declared for each hypothesis firstly for CAR Weeks 9-12, and then secondly for CAR Weeks 9-52 until a p-value > 0.05 was obtained, at which point the hypothesis would be declared to be not statistically significant.|Regression, Logistic|The analysis model included main effect of treatment and pooled center.||The study was conducted on a sample size to achieve at least 90% power for the treatment comparison in the primary efficacy endpoint assuming an odds ratio of 3.36 with a placebo abstinence rate of 12% and varenicline abstinence rate of 31%. The intent of the primary efficacy analysis was to evaluate the hypothesis that varenicline is superior to placebo for smoking cessation after 12 weeks of treatment.|
1680173|NCT01244035|3091037|Other||LS Mean difference|-0.18||||0.4506|2-Sided|90.0|-2.54|2.19|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.|||
1680174|NCT01244035|3091037|Other||LS Mean difference|-2.76||||0.0299|2-Sided|90.0|-5.16|-0.36|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.|||
1680175|NCT01244035|3091037|Other||LS Mean difference|-2.94||||0.0212|2-Sided|90.0|-5.3|-0.57|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.|||
1680176|NCT01244035|3091038|Other||LS Mean difference|-3.06||||0.0016|2-Sided|90.0|-4.7|-1.42|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.|||
1680177|NCT01244035|3091038|Other||LS Mean difference|4.16|||<|0.001|2-Sided|90.0|2.53|5.79|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.|||
1680178|NCT01244035|3091038|Other||LS Mean difference|1.1|||<|0.1325|2-Sided|90.0|-0.54|2.74|||Linear mixed effects model|Period and treatment were fixed effects and participant was a random effect.|||
1680179|NCT01243957|3091046|Superiority or Other||Median Difference (Final Values)|-4.0||||0.0293|2-Sided|90.0|-6.5|-1.0|||Wilcoxon (Mann-Whitney)|||Ratio of Geometric LS Means of Tmax for norfluoxetine alone and norfluoxetine + LY2216684.|
1680180|NCT01243957|3091046|Superiority or Other||Median Difference (Final Values)|-0.08||||0.423|2-Sided|90.0|-3.0|1.42|||Wilcoxon (Mann-Whitney)|||Ratio of Geometric LS Means of Tmax for fluoxetine alone and fluoxetine + LY2216684.|
1680181|NCT01243957|3091047|Superiority or Other||Ratio of Geometric LS Means|1.03|||||2-Sided|90.0|1.0|1.07||||||Ratio of Geometric LS Means of Cmax for norfluoxetine alone and norfluoxetine + LY2216684.|
1680182|NCT01243957|3091047|Superiority or Other||Ratio of Geometric LS Means|1.0|||||2-Sided|90.0|0.97|1.03||||||Ratio of Geometric LS Means of Cmax for fluoxetine alone and fluoxetine + LY2216684|
1680183|NCT01243957|3091048|Superiority or Other||Ratio of Geometric LS Means|1.04|||||2-Sided|90.0|1.01|1.06||||||Ratio of Geometric LS Means of AUCτ for norfluoxetine alone and norfluoxetine + LY2216684.|
1680184|NCT01243957|3091048|Superiority or Other||Ratio of Geometric LS Means|1.01|||||2-Sided|90.0|0.99|1.04||||||Ratio of Geometric LS Means of AUCτ for fluoxetine alone and fluoxetine + LY2216684.|
1680185|NCT01243957|3091049|Superiority or Other||Median Difference (Final Values)|0.0||||0.5459|2-Sided|90.0|-0.5|0.5|||Wilcoxon (Mann-Whitney)||||
1680186|NCT01243957|3091050|Superiority or Other||Ratio of Geometric LS Means|1.63|||||2-Sided|90.0|1.49|1.79|||||||
1680187|NCT01243957|3091051|Superiority or Other||Ratio of Geometric LS Means|1.79|||||2-Sided|90.0|1.61|2.0|||||||
1680188|NCT01243944|3091062|Superiority or Other||Odds Ratio (OR)|3.57||||0.0016|2-Sided|95.0|1.5|9.06|||Exact Cochran-Mantel-Haenszel|P-value was calculated using stratified exact Cochran-Mantel-Haenszel test by adjusting for the WBC/platelet status (abnormal vs normal) at baseline.|||
1680189|NCT01243944|3091063|Superiority or Other||Odds Ratio (OR)|28.01|||<|0.0001|2-Sided|95.0|4.24|1144.0|||Exact Cochran-Mantel-Haenszel||||
1680190|NCT01243944|3091064|Superiority or Other||Odds Ratio, log|32.67|||<|0.0001|2-Sided|95.0|5.04|1337.0|||Exact Cochran-Mantel-Haenszel||||
1680191|NCT01243580|3091089|Equivalence|Comparison of Ortho-Cyclen and AG200-15||||||0.0532|||||||ANOVA||||
1680192|NCT01243580|3091090|Equivalence|Comparison of Ortho-Cyclen and AG200-15||||||0.0001|||||||ANOVA||||
1680193|NCT01243580|3091091|Equivalence|Comparison of Ortho-Cyclen and AG200-15||||||0.0175|||||||ANOVA||||
1680194|NCT01243580|3091092|Equivalence|Comparison of Ortho-Cyclen and AG200-15||||||0.0007|||||||ANOVA||||
1680195|NCT01243580|3091093|Equivalence|Comparison of Ortho-Cyclen and AG200-15||||||0.0167|||||||ANOVA||||
1680196|NCT01243580|3091094|Equivalence|Comparison of Ortho-Cyclen and AG200-15||||||0.0009|||||||ANOVA||||
1680197|NCT01243580|3091095|Equivalence|Comparison of Ortho-Cylen and AG200-15||||||0.0532|||||||ANOVA||||
1680198|NCT01243580|3091096|Equivalence|Comparison of AG200-15 and Ortho-Cyclen||||||0.0001|||||||ANOVA||||
1680199|NCT01243580|3091097|Equivalence|Comparison of AG200-15 and Ortho-Cyclen|||||<|0.0001|||||||ANOVA||||
1680200|NCT01243580|3091098|Equivalence|Comparing Ortho-Cyclen to Ag200-15|||||<|0.0001|||||||ANOVA||||
1680201|NCT01243424|3091107|Other||Odds Ratio (OR)|1.01||||0.9112|2-Sided|95.0|0.86|1.18|||Regression, Logistic|Logistic regression model with terms for treatment as a fixed effect with Wald confidence Interval was used.|Linagliptin vs. Glimepiride odds is presented.|This was the fifth step in a pre-defined hierarchical testing approach.|
1680202|NCT01243424|3091108|Equivalence|This was the fifth step in a pre-defined hierarchical testing approach.|Mean Difference (Net)|4.13||||0.8402|2-Sided|95.0|-36.46|44.71|||ANCOVA|The ANCOVA model includes the fixed categorical effects of treatment and the continuous covariate of baseline ISR.|Mean difference= Linagliptin mean- Glimepiride mean||
1680203|NCT01243424|3091110|Other||geometric mean (gMean) ratio (%)|0.97||||0.2921|2-Sided|95.0|0.91|1.03|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline UACR.|gMean ration= Linagliptin mean/ Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.|
1680204|NCT01243424|3091111|Other||Mean Difference (Final Values)|1.0|Standard Error of the Mean|0.4||0.5165|2-Sided|95.0|0.2|1.8|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline eGFR.|Mean difference = Linagliptin mean – Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.|
1680205|NCT01243424|3091112|Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.01||0.5165|2-Sided|95.0|-0.03|0.01|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline creatinine.|Mean difference = Linagliptin mean – Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.|
1680206|NCT01243424|3091113|Other||Mean Difference (Final Values)|-3.5|Standard Error of the Mean|3.1||0.2678|2-Sided|95.0|-9.6|2.7|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline FPG.|Mean difference = Linagliptin mean – Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.|
1680207|NCT01243424|3091114|Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|1.0||0.6823|2-Sided|95.0|-2.4|1.6|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline total cholesterol.|Mean difference = Linagliptin mean – Glimepiride mean|Total cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.|
1680208|NCT01243424|3091114|Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.2||0.0497|2-Sided|95.0|0.0|1.0|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline HDL cholesterol.|Mean difference = Linagliptin mean – Glimepiride mean|HDL cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.|
1680209|NCT01243424|3091114|Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.9||0.64|2-Sided|95.47|-1.3|2.1|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline LDL cholesterol.|Mean difference = Linagliptin mean – Glimepiride mean|LDL cholesterol, this was the fifth step in a pre-defined hierarchical testing approach.|
1680210|NCT01243424|3091115|Other||Mean Difference (Final Values)|-7.3|Standard Error of the Mean|1.2|<|0.0001|2-Sided|95.0|-9.7|-4.8|||ANCOVA|The ANCOVA model includes the fixed categorical effect of treatment and the continuous covariate of baseline FPG.|Mean difference = Linagliptin mean – Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.|
1680211|NCT01243424|3091116|Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.03||0.0023|2-Sided|95.0|-0.15|-0.03|||ANCOVA|The Analysis of Covariance (ANCOVA) model includes the fixed categorical effect of treatment and the continuous covariate of baseline HbA1c.|Mean difference = Linagliptin mean – Glimepiride mean|This was the fifth step in a pre-defined hierarchical testing approach.|
1680212|NCT01243424|3091117|Other||Hazard Ratio (HR)|0.96||||0.5249|2-Sided|95.0|0.85|1.09||p−value derived from Wald´s chi−square test.|Regression, Cox||Hazard ratio and confidence interval derived from Cox regression with factor treatment.|This was the fifth step in a pre-defined hierarchical testing approach.|
1680213|NCT01243424|3091121|Other||Odds Ratio (OR)|1.29||||0.0004|2-Sided|95.47|1.11|1.48||p−value derived from logistic regression.|Regression, Logistic||Odds ratio and confidence interval are based on logistic regression with factor for treatment.|This was the fifth step in a pre-defined hierarchical testing approach.|
1680214|NCT01243424|3091122|Other||Odds Ratio (OR)|1.68|||<|0.0001|2-Sided|95.47|1.43|1.96||p−value derived from logistic regression.|Regression, Logistic||Odds ratio and confidence interval are based on logistic regression with factor for treatment.||
1680215|NCT01243424|3091123|Superiority|This was the third step in a pre-defined hierarchical testing approach.|Hazard Ratio (HR)|0.99||||0.4334|2-Sided|95.47|0.86|1.14||P-values derived from Wald´s Chi-square test for non-inferiority.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.|||
1680216|NCT01243424|3091124|Superiority|This was the second step in a pre-defined hierarchical testing approach.|Hazard Ratio (HR)|0.98||||0.3813|2-Sided|95.47|0.84|1.14||P-values derived from Wald´s Chi-square test.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride.|||
1680217|NCT01243424|3091124|Non-Inferiority|This was the first step in a pre-defined hierarchical testing approach. The upper bound of the confidence interval (CI) of the Hazard ratio (HR) of linagliptin vs. glimepiride was compared with this noninferiority margin for the testing of non-inferiority. All non-inferiority tests were based on a margin of 1.3.|Hazard Ratio (HR)|0.98|||<|0.0001|2-Sided|95.47|0.84|1.14||P-values derived from Wald´s Chi-square test for non-inferiority were calculated.|Regression, Cox|Cox proportional-hazard model with factor treatment was applied to compare linagliptin with glimepiride|||
1680218|NCT01243242|3091185|Superiority or Other|||||||0.0093||||||p value for the difference between groups in change from Screening to Termination was calculated using ANCOVA, adjusted for baseline score, gender, site and age.|ANCOVA|||Analysis of covariance (ANCOVA) was applied for comparing the differences in changes from screening/baseline (Visit 1) to termination (Visit 6) between the study groups with adjustment to confounders (baseline score, site, age, gender, dose and past exposure to any other ADHD drug).|
1680219|NCT01243242|3091186|Superiority or Other|||||||0.0195||||||p value for the difference between groups in change from Screening to Termination was calculated using ANCOVA, adjusted for baseline score, gender, site and age|ANCOVA|||Analysis of Covariance (ANCOVA) was applied for comparing the differences in changes from screening/baseline (Visit 1) to termination (Visit 6) and to Visits 3 through 5 in the primary endpoint, CAARS, and secondary endpoint scales, CGI-S, TOVA and AAQoL between the study groups with adjustment to confounders (baseline score, site, age, gender, dose and past exposure to any other ADHD drug).|
1681200|NCT01235507|3092174|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 16|
1680220|NCT01243242|3091187|Superiority or Other|||||||0.0093||||||p value for the difference between groups in change from Screening to Termination was calculated using the median test for independent samples|Median|||For the primary endpoint (CAARS change), median test was applied as the primary analysis due to outlier numbers observed ; secondary analysis of the primary endpoint utilized ANCOVA with adjustment to age, gender and site (which is usually expected to influence the endpoint) as well as baseline values. Additional parametric T-test was applied, but was found less effective due to outlier values.|
1680221|NCT01243177|3091192|Non-Inferiority or Equivalence|"The hypothesis was as follows:~H0: [S(t)LCM] – [S(t)CBZ-CR] ≤ -12 % versus HA: [S(t)LCM] - [S(t)CBZ-CR] > -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference."|Mean Difference (Final Values)|-1.3|||||2-Sided|95.0|-5.3|2.7|||||The lower limit of the confidence interval was >-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was >- 20 %.|This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.|
1680222|NCT01243177|3091193|Non-Inferiority or Equivalence|"The hypothesis was as follows:~H0: [S(t)LCM] – [S(t)CBZ-CR] ≤ -12 % versus HA: [S(t)LCM] - [S(t)CBZ-CR] > -12 %, where S(t) (t= 182 days) is the cumulative rate of subjects remaining seizure free for 6 months following stabilization at the last evaluated dose (also known as the survivorship function), and -12 % represents the noninferiority margin based on absolute difference."|Mean Difference (Final Values)|-1.3|||||2-Sided|95.0|-5.5|2.8|||||The lower limit of the confidence interval was >-12 %, noninferiority of LCM to CBZ-CR was demonstrated. Additionally, the lower confidence limit relative to the CBZ-CR seizure freedom rate was >- 20 %.|This was a noninferiority assessment of Lacosamide versus Carbamazepine-CR for the proportion of subjects remaining seizure free for 6 months at the last evaluated dose.|
1680223|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-16.53|Standard Error of the Mean|19.601||0.3999|2-Sided|95.0|-55.13|22.07|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680224|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-14.65|Standard Error of the Mean|20.332||0.4719|2-Sided|95.0|-54.69|25.39|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680225|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-11.56|Standard Error of the Mean|20.069||0.5651|2-Sided|95.0|-51.08|27.96|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680226|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-12.33|Standard Error of the Mean|19.918||0.5364|2-Sided|95.0|-51.55|26.89|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680227|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-17.95|Standard Error of the Mean|19.601||0.3606|2-Sided|95.0|-56.55|20.65|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680228|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-19.47|Standard Error of the Mean|20.332||0.3391|2-Sided|95.0|-59.51|20.57|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680229|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-12.83|Standard Error of the Mean|20.069||0.5233|2-Sided|95.0|-52.35|26.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680230|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-17.42|Standard Error of the Mean|19.918||0.3826|2-Sided|95.0|-56.64|21.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680231|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-11.15|Standard Error of the Mean|19.601||0.5699|2-Sided|95.0|-49.75|27.45|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680232|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-8.3|Standard Error of the Mean|20.332||0.6835|2-Sided|95.0|-48.34|31.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680233|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-11.84|Standard Error of the Mean|20.069||0.5558|2-Sided|95.0|-51.36|27.69|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680234|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-11.45|Standard Error of the Mean|19.581||0.559|2-Sided|95.0|-50.01|27.1|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680425|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|124.439||||0.0038|2-Sided|95.0|4.73|3277.13|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680235|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-4.21|Standard Error of the Mean|19.601||0.8302|2-Sided|95.0|-42.81|34.39|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680236|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-13.39|Standard Error of the Mean|19.979||0.5035|2-Sided|95.0|-52.73|25.96|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680237|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-11.94|Standard Error of the Mean|20.069||0.5525|2-Sided|95.0|-51.46|27.59|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680238|NCT01243151|3091211|Superiority or Other||LS Mean Difference|-0.52|Standard Error of the Mean|19.581||0.9789|2-Sided|95.0|-39.08|38.04|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680239|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-49.94|Standard Error of the Mean|4.312|<|0.0001|2-Sided|95.0|-58.58|-41.31|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680240|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-52.36|Standard Error of the Mean|4.437|<|0.0001|2-Sided|95.0|-61.25|-43.48|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680241|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-43.75|Standard Error of the Mean|4.464|<|0.0001|2-Sided|95.0|-52.68|-34.81|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680242|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-40.82|Standard Error of the Mean|4.373|<|0.0001|2-Sided|95.0|-49.58|-32.07|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680243|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-51.75|Standard Error of the Mean|4.222|<|0.0001|2-Sided|95.0|-60.25|-43.26|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680244|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-54.49|Standard Error of the Mean|4.346|<|0.0001|2-Sided|95.0|-63.23|-45.75|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680245|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-48.78|Standard Error of the Mean|4.374|<|0.0001|2-Sided|95.0|-57.58|-39.99|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680246|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-45.37|Standard Error of the Mean|4.275|<|0.0001|2-Sided|95.0|-53.96|-36.77|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680247|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-46.93|Standard Error of the Mean|5.453|<|0.0001|2-Sided|95.0|-57.87|-36.0|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680248|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-47.42|Standard Error of the Mean|5.599|<|0.0001|2-Sided|95.0|-58.64|-36.2|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680249|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-38.12|Standard Error of the Mean|5.61|<|0.0001|2-Sided|95.0|-49.36|-26.88|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680250|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-41.38|Standard Error of the Mean|5.467|<|0.0001|2-Sided|95.0|-52.34|-30.42|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680251|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-33.42|Standard Error of the Mean|3.931|<|0.0001|2-Sided|95.0|-41.3|-25.54|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680252|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-35.27|Standard Error of the Mean|4.003|<|0.0001|2-Sided|95.0|-43.29|-27.24|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680253|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-26.62|Standard Error of the Mean|4.084|<|0.0001|2-Sided|95.0|-34.8|-18.44|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680254|NCT01243151|3091212|Superiority or Other||LS Mean Difference|-30.64|Standard Error of the Mean|3.951|<|0.0001|2-Sided|95.0|-38.56|-22.72|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680255|NCT01243151|3091213|Superiority or Other||LS Mean Difference|13.65|Standard Error of the Mean|4.709||0.0053|2-Sided|95.0|4.23|23.08|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680256|NCT01243151|3091213|Superiority or Other||LS Mean Difference|4.31|Standard Error of the Mean|4.819||0.3751|2-Sided|95.0|-5.34|13.96|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680257|NCT01243151|3091213|Superiority or Other||LS Mean Difference|6.69|Standard Error of the Mean|4.807||0.1692|2-Sided|95.0|-2.93|16.32|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680258|NCT01243151|3091213|Superiority or Other||LS Mean Difference|8.69|Standard Error of the Mean|4.712||0.0702|2-Sided|95.0|-0.74|18.13|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680259|NCT01243151|3091213|Superiority or Other||LS Mean Difference|11.59|Standard Error of the Mean|4.076||0.0062|2-Sided|95.0|3.42|19.75|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680260|NCT01243151|3091213|Superiority or Other||LS Mean Difference|2.13|Standard Error of the Mean|4.157||0.6107|2-Sided|95.0|-6.2|10.45|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680261|NCT01243151|3091213|Superiority or Other||LS Mean Difference|7.16|Standard Error of the Mean|4.165||0.0909|2-Sided|95.0|-1.18|15.5|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680262|NCT01243151|3091213|Superiority or Other||LS Mean Difference|7.31|Standard Error of the Mean|4.064||0.0774|2-Sided|95.0|-0.83|15.45|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680263|NCT01243151|3091213|Superiority or Other||LS Mean Difference|11.78|Standard Error of the Mean|4.358||0.0091|2-Sided|95.0|3.05|20.52|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680264|NCT01243151|3091213|Superiority or Other||LS Mean Difference|9.06|Standard Error of the Mean|4.44||0.0462|2-Sided|95.0|0.16|17.96|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680265|NCT01243151|3091213|Superiority or Other||LS Mean Difference|10.86|Standard Error of the Mean|4.451||0.0179|2-Sided|95.0|1.95|19.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680266|NCT01243151|3091213|Superiority or Other||LS Mean Difference|14.95|Standard Error of the Mean|4.293||0.001|2-Sided|95.0|6.34|23.56|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680267|NCT01243151|3091213|Superiority or Other||LS Mean Difference|5.59|Standard Error of the Mean|4.045||0.1723|2-Sided|95.0|-2.51|13.7|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680268|NCT01243151|3091213|Superiority or Other||LS Mean Difference|0.54|Standard Error of the Mean|4.054||0.8953|2-Sided|95.0|-7.59|8.67|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680269|NCT01243151|3091213|Superiority or Other||LS Mean Difference|5.22|Standard Error of the Mean|4.133||0.2122|2-Sided|95.0|-3.07|13.5|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680270|NCT01243151|3091213|Superiority or Other||LS Mean Difference|4.44|Standard Error of the Mean|3.975||0.269|2-Sided|95.0|-3.53|12.41|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680271|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-36.04|Standard Error of the Mean|4.207|<|0.0001|2-Sided|95.0|-44.39|-27.69|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680426|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|213.512||||0.002|2-Sided|95.0|7.13|6396.64|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680272|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-41.34|Standard Error of the Mean|4.318|<|0.0001|2-Sided|95.0|-49.91|-32.78|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680273|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-31.22|Standard Error of the Mean|4.315|<|0.0001|2-Sided|95.0|-39.79|-22.65|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680274|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-29.77|Standard Error of the Mean|4.246|<|0.0001|2-Sided|95.0|-38.19|-21.34|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680275|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-38.0|Standard Error of the Mean|4.207|<|0.0001|2-Sided|95.0|-46.35|-29.65|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680276|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-43.28|Standard Error of the Mean|4.318|<|0.0001|2-Sided|95.0|-51.85|-34.71|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680277|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-35.41|Standard Error of the Mean|4.315|<|0.0001|2-Sided|95.0|-43.98|-26.85|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680278|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-33.96|Standard Error of the Mean|4.246|<|0.0001|2-Sided|95.0|-42.39|-25.53|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680279|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-34.23|Standard Error of the Mean|4.207|<|0.0001|2-Sided|95.0|-42.58|-25.88|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680280|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-35.89|Standard Error of the Mean|4.318|<|0.0001|2-Sided|95.0|-44.46|-27.33|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680281|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-26.35|Standard Error of the Mean|4.315|<|0.0001|2-Sided|95.0|-34.92|-17.79|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680282|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-28.89|Standard Error of the Mean|4.211|<|0.0001|2-Sided|95.0|-37.25|-20.53|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680283|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-24.89|Standard Error of the Mean|4.207|<|0.0001|2-Sided|95.0|-33.24|-16.54|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680284|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-27.97|Standard Error of the Mean|4.274|<|0.0001|2-Sided|95.0|-36.46|-19.49|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680285|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-18.6|Standard Error of the Mean|4.315|<|0.0001|2-Sided|95.0|-27.17|-10.03|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680286|NCT01243151|3091214|Superiority or Other||LS Mean Difference|-22.7|Standard Error of the Mean|4.211|<|0.0001|2-Sided|95.0|-31.06|-14.34|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680287|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-48.04|Standard Error of the Mean|4.639|<|0.0001|2-Sided|95.0|-57.33|-38.76|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680288|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-49.75|Standard Error of the Mean|4.722|<|0.0001|2-Sided|95.0|-59.2|-40.3|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680289|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-41.19|Standard Error of the Mean|4.795|<|0.0001|2-Sided|95.0|-50.78|-31.6|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680290|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-38.61|Standard Error of the Mean|4.616|<|0.0001|2-Sided|95.0|-47.85|-29.37|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680291|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-45.77|Standard Error of the Mean|4.363|<|0.0001|2-Sided|95.0|-54.52|-37.03|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680292|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-46.98|Standard Error of the Mean|4.441|<|0.0001|2-Sided|95.0|-55.88|-38.08|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680293|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-40.98|Standard Error of the Mean|4.519|<|0.0001|2-Sided|95.0|-50.04|-31.93|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680294|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-37.75|Standard Error of the Mean|4.343|<|0.0001|2-Sided|95.0|-46.46|-29.05|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680295|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-41.87|Standard Error of the Mean|5.097|<|0.0001|2-Sided|95.0|-52.07|-31.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680296|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-42.57|Standard Error of the Mean|5.194|<|0.0001|2-Sided|95.0|-52.96|-32.18|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680297|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-34.14|Standard Error of the Mean|5.255|<|0.0001|2-Sided|95.0|-44.65|-23.63|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680298|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-33.3|Standard Error of the Mean|5.055|<|0.0001|2-Sided|95.0|-43.42|-23.19|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680299|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-30.43|Standard Error of the Mean|4.169|<|0.0001|2-Sided|95.0|-38.78|-22.08|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680300|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-31.2|Standard Error of the Mean|4.182|<|0.0001|2-Sided|95.0|-39.58|-22.83|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680301|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-24.29|Standard Error of the Mean|4.325|<|0.0001|2-Sided|95.0|-32.95|-15.63|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680302|NCT01243151|3091215|Superiority or Other||LS Mean Difference|-26.35|Standard Error of the Mean|4.117|<|0.0001|2-Sided|95.0|-34.59|-18.1|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680303|NCT01243151|3091216|Superiority or Other||LS Mean Difference|7.6|Standard Error of the Mean|3.411||0.0297|2-Sided|95.0|0.78|14.43|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680304|NCT01243151|3091216|Superiority or Other||LS Mean Difference|3.71|Standard Error of the Mean|3.495||0.2923|2-Sided|95.0|-3.28|10.71|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680305|NCT01243151|3091216|Superiority or Other||LS Mean Difference|5.41|Standard Error of the Mean|3.479||0.1252|2-Sided|95.0|-1.55|12.37|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680306|NCT01243151|3091216|Superiority or Other||LS Mean Difference|7.6|Standard Error of the Mean|3.428||0.0305|2-Sided|95.0|0.74|14.46|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680307|NCT01243151|3091216|Superiority or Other||LS Mean Difference|9.78|Standard Error of the Mean|3.192||0.0034|2-Sided|95.0|3.38|16.17|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680308|NCT01243151|3091216|Superiority or Other||LS Mean Difference|1.76|Standard Error of the Mean|3.279||0.5936|2-Sided|95.0|-4.81|8.33|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680309|NCT01243151|3091216|Superiority or Other||LS Mean Difference|6.27|Standard Error of the Mean|3.258||0.0593|2-Sided|95.0|-0.25|12.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680310|NCT01243151|3091216|Superiority or Other||LS Mean Difference|6.74|Standard Error of the Mean|3.214||0.0405|2-Sided|95.0|0.3|13.18|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680311|NCT01243151|3091216|Superiority or Other||LS Mean Difference|7.76|Standard Error of the Mean|4.244||0.0725|2-Sided|95.0|-0.73|16.25|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680312|NCT01243151|3091216|Superiority or Other||LS Mean Difference|5.04|Standard Error of the Mean|4.367||0.2529|2-Sided|95.0|-3.69|13.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680313|NCT01243151|3091216|Superiority or Other||LS Mean Difference|6.84|Standard Error of the Mean|4.326||0.1192|2-Sided|95.0|-1.82|15.49|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680314|NCT01243151|3091216|Superiority or Other||LS Mean Difference|10.01|Standard Error of the Mean|4.221||0.021|2-Sided|95.0|1.56|18.46|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680315|NCT01243151|3091216|Superiority or Other||LS Mean Difference|3.42|Standard Error of the Mean|3.433||0.3227|2-Sided|95.0|-3.45|10.3|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680316|NCT01243151|3091216|Superiority or Other||LS Mean Difference|0.52|Standard Error of the Mean|3.466||0.8812|2-Sided|95.0|-6.42|7.46|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680317|NCT01243151|3091216|Superiority or Other||LS Mean Difference|3.69|Standard Error of the Mean|3.502||0.2967|2-Sided|95.0|-3.32|10.7|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680318|NCT01243151|3091216|Superiority or Other||LS Mean Difference|3.33|Standard Error of the Mean|3.404||0.3326|2-Sided|95.0|-3.49|10.14|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680319|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-33.26|Standard Error of the Mean|29.37||0.2586|2-Sided|95.0|-91.11|24.6|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680320|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-56.32|Standard Error of the Mean|30.458||0.0657|2-Sided|95.0|-116.31|3.68|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680321|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-23.88|Standard Error of the Mean|30.091||0.4283|2-Sided|95.0|-83.16|35.4|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680322|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-26.56|Standard Error of the Mean|29.828||0.3741|2-Sided|95.0|-85.32|32.19|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680323|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-31.51|Standard Error of the Mean|29.37||0.2844|2-Sided|95.0|-89.36|26.35|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680324|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-52.15|Standard Error of the Mean|30.458||0.0881|2-Sided|95.0|-112.15|7.85|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680325|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-23.78|Standard Error of the Mean|30.091||0.4301|2-Sided|95.0|-83.06|35.5|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680326|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-30.7|Standard Error of the Mean|29.828||0.3045|2-Sided|95.0|-89.45|28.06|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680327|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-21.41|Standard Error of the Mean|29.37||0.4667|2-Sided|95.0|-79.27|36.44|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680427|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|146.296||||0.0031|2-Sided|95.0|5.4|3963.01|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680328|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-17.73|Standard Error of the Mean|30.458||0.561|2-Sided|95.0|-77.73|42.26|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680329|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-21.5|Standard Error of the Mean|30.091||0.4756|2-Sided|95.0|-80.78|37.78|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680330|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-19.83|Standard Error of the Mean|29.336||0.4997|2-Sided|95.0|-77.62|37.96|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680331|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-16.52|Standard Error of the Mean|29.37||0.5743|2-Sided|95.0|-74.38|41.33|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680332|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-31.92|Standard Error of the Mean|29.942||0.2875|2-Sided|95.0|-90.9|27.07|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680333|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-32.52|Standard Error of the Mean|30.091||0.2809|2-Sided|95.0|-91.8|26.76|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680334|NCT01243151|3091217|Superiority or Other||LS Mean Difference|-22.3|Standard Error of the Mean|29.336||0.448|2-Sided|95.0|-80.08|35.49|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680335|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-97.0|Standard Error of the Mean|8.426|<|0.0001|2-Sided|95.0|-113.89|-80.11|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680336|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-104.74|Standard Error of the Mean|8.679|<|0.0001|2-Sided|95.0|-122.13|-87.35|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680337|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-83.89|Standard Error of the Mean|8.736|<|0.0001|2-Sided|95.0|-101.4|-66.39|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680338|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-79.07|Standard Error of the Mean|8.557|<|0.0001|2-Sided|95.0|-96.22|-61.93|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680339|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-99.18|Standard Error of the Mean|8.334|<|0.0001|2-Sided|95.0|-115.95|-82.4|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680340|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-106.06|Standard Error of the Mean|8.585|<|0.0001|2-Sided|95.0|-123.34|-88.78|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680341|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-92.18|Standard Error of the Mean|8.643|<|0.0001|2-Sided|95.0|-109.57|-74.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680342|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-86.73|Standard Error of the Mean|8.452|<|0.0001|2-Sided|95.0|-103.73|-69.72|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680343|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-89.5|Standard Error of the Mean|10.736|<|0.0001|2-Sided|95.0|-111.03|-67.97|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680344|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-91.83|Standard Error of the Mean|11.018|<|0.0001|2-Sided|95.0|-113.92|-69.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680345|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-71.28|Standard Error of the Mean|11.051|<|0.0001|2-Sided|95.0|-93.43|-49.13|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680428|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|745.542||||0.0018|2-Sided|95.0|11.6|47929.45|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680346|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-78.46|Standard Error of the Mean|10.766|<|0.0001|2-Sided|95.0|-100.05|-56.87|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680347|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-66.25|Standard Error of the Mean|8.112|<|0.0001|2-Sided|95.0|-82.55|-49.94|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680348|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-69.46|Standard Error of the Mean|8.26|<|0.0001|2-Sided|95.0|-86.06|-52.86|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680349|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-52.53|Standard Error of the Mean|8.422|<|0.0001|2-Sided|95.0|-69.45|-35.61|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680350|NCT01243151|3091218|Superiority or Other||LS Mean Difference|-60.35|Standard Error of the Mean|8.152|<|0.0001|2-Sided|95.0|-76.74|-43.97|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680351|NCT01243151|3091219|Superiority or Other||LS Mean Difference|6.56|Standard Error of the Mean|2.485||0.0107|2-Sided|95.0|1.58|11.53|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680352|NCT01243151|3091219|Superiority or Other||LS Mean Difference|1.57|Standard Error of the Mean|2.547||0.5407|2-Sided|95.0|-3.53|6.67|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680353|NCT01243151|3091219|Superiority or Other||LS Mean Difference|3.65|Standard Error of the Mean|2.536||0.1552|2-Sided|95.0|-1.42|8.73|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680354|NCT01243151|3091219|Superiority or Other||LS Mean Difference|4.0|Standard Error of the Mean|2.492||0.1141|2-Sided|95.0|-0.99|8.99|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680355|NCT01243151|3091219|Superiority or Other||LS Mean Difference|5.65|Standard Error of the Mean|2.106||0.0095|2-Sided|95.0|1.44|9.87|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680356|NCT01243151|3091219|Superiority or Other||LS Mean Difference|0.51|Standard Error of the Mean|2.15||0.8123|2-Sided|95.0|-3.79|4.82|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680357|NCT01243151|3091219|Superiority or Other||LS Mean Difference|3.4|Standard Error of the Mean|2.151||0.1199|2-Sided|95.0|-0.91|7.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680358|NCT01243151|3091219|Superiority or Other||LS Mean Difference|3.25|Standard Error of the Mean|2.101||0.127|2-Sided|95.0|-0.95|7.46|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680359|NCT01243151|3091219|Superiority or Other||LS Mean Difference|5.08|Standard Error of the Mean|2.19||0.0242|2-Sided|95.0|0.69|9.47|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680360|NCT01243151|3091219|Superiority or Other||LS Mean Difference|3.87|Standard Error of the Mean|2.232||0.089|2-Sided|95.0|-0.61|8.34|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680361|NCT01243151|3091219|Superiority or Other||LS Mean Difference|5.09|Standard Error of the Mean|2.237||0.0269|2-Sided|95.0|0.6|9.57|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680362|NCT01243151|3091219|Superiority or Other||LS Mean Difference|6.64|Standard Error of the Mean|2.158||0.0033|2-Sided|95.0|2.31|10.97|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680363|NCT01243151|3091219|Superiority or Other||LS Mean Difference|2.45|Standard Error of the Mean|1.981||0.2211|2-Sided|95.0|-1.52|6.42|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680429|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|150.547||||0.0034|2-Sided|95.0|5.28|4291.89|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680364|NCT01243151|3091219|Superiority or Other||LS Mean Difference|0.82|Standard Error of the Mean|1.984||0.6827|2-Sided|95.0|-3.16|4.79|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680365|NCT01243151|3091219|Superiority or Other||LS Mean Difference|2.67|Standard Error of the Mean|2.025||0.1922|2-Sided|95.0|-1.38|6.73|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680366|NCT01243151|3091219|Superiority or Other||LS Mean Difference|2.01|Standard Error of the Mean|1.945||0.3064|2-Sided|95.0|-1.89|5.9|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680367|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-87.15|Standard Error of the Mean|10.381|<|0.0001|2-Sided|95.0|-107.76|-66.55|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680368|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-102.35|Standard Error of the Mean|10.656|<|0.0001|2-Sided|95.0|-123.49|-81.21|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680369|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-74.46|Standard Error of the Mean|10.646|<|0.0001|2-Sided|95.0|-95.59|-53.32|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680370|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-71.54|Standard Error of the Mean|10.479|<|0.0001|2-Sided|95.0|-92.34|-50.75|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680371|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-90.23|Standard Error of the Mean|10.381|<|0.0001|2-Sided|95.0|-110.84|-69.63|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680372|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-104.77|Standard Error of the Mean|10.656|<|0.0001|2-Sided|95.0|-125.91|-83.62|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680373|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-83.0|Standard Error of the Mean|10.646|<|0.0001|2-Sided|95.0|-104.14|-61.87|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680374|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-80.16|Standard Error of the Mean|10.479|<|0.0001|2-Sided|95.0|-100.96|-59.37|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680375|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-81.13|Standard Error of the Mean|10.381|<|0.0001|2-Sided|95.0|-101.73|-60.52|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680376|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-86.6|Standard Error of the Mean|10.656|<|0.0001|2-Sided|95.0|-107.74|-65.46|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680377|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-60.41|Standard Error of the Mean|10.646|<|0.0001|2-Sided|95.0|-81.54|-39.27|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680378|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-68.39|Standard Error of the Mean|10.392|<|0.0001|2-Sided|95.0|-89.02|-47.76|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680379|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-60.51|Standard Error of the Mean|10.381|<|0.0001|2-Sided|95.0|-81.11|-39.9|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680380|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-67.98|Standard Error of the Mean|10.547|<|0.0001|2-Sided|95.0|-88.92|-47.05|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680381|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-44.07|Standard Error of the Mean|10.646|<|0.0001|2-Sided|95.0|-65.21|-22.94|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680382|NCT01243151|3091220|Superiority or Other||LS Mean Difference|-54.91|Standard Error of the Mean|10.392|<|0.0001|2-Sided|95.0|-75.54|-34.29|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680383|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-60.01|Standard Error of the Mean|5.785|<|0.0001|2-Sided|95.0|-71.59|-48.42|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680384|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-64.22|Standard Error of the Mean|5.901|<|0.0001|2-Sided|95.0|-76.04|-52.4|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680385|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-51.52|Standard Error of the Mean|5.974|<|0.0001|2-Sided|95.0|-63.48|-39.56|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680386|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-49.06|Standard Error of the Mean|5.767|<|0.0001|2-Sided|95.0|-60.61|-37.51|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680387|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-57.03|Standard Error of the Mean|5.377|<|0.0001|2-Sided|95.0|-67.83|-46.24|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680388|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-59.89|Standard Error of the Mean|5.482|<|0.0001|2-Sided|95.0|-70.89|-48.89|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680389|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-51.08|Standard Error of the Mean|5.566|<|0.0001|2-Sided|95.0|-62.24|-39.91|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680390|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-47.35|Standard Error of the Mean|5.359|<|95|2-Sided|95.0|-58.1|-36.59|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680391|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-51.89|Standard Error of the Mean|6.321|<|0.0001|2-Sided|95.0|-64.54|-39.25|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680392|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-54.56|Standard Error of the Mean|6.445|<|0.0001|2-Sided|95.0|-67.45|-41.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680393|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-42.69|Standard Error of the Mean|6.512|<|0.0001|2-Sided|95.0|-55.72|-29.67|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680394|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-42.18|Standard Error of the Mean|6.271|<|0.0001|2-Sided|95.0|-54.73|-29.63|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680395|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-38.37|Standard Error of the Mean|5.07|<|0.0001|2-Sided|95.0|-48.54|-28.2|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680396|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-39.98|Standard Error of the Mean|5.088|<|0.0001|2-Sided|95.0|-50.18|-29.77|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680397|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-30.8|Standard Error of the Mean|5.26|<|0.0001|2-Sided|95.0|-41.34|-20.26|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680398|NCT01243151|3091221|Superiority or Other||LS Mean Difference|-32.88|Standard Error of the Mean|5.008|<|0.0001|2-Sided|95.0|-42.93|-22.84|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680399|NCT01243151|3091222|Superiority or Other||LS Mean Difference|9.96|Standard Error of the Mean|5.132||0.057|2-Sided|95.0|-0.31|20.24|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680400|NCT01243151|3091222|Superiority or Other||LS Mean Difference|5.98|Standard Error of the Mean|5.258||0.2601|2-Sided|95.0|-4.54|16.5|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680401|NCT01243151|3091222|Superiority or Other||LS Mean Difference|8.56|Standard Error of the Mean|5.235||0.1075|2-Sided|95.0|-1.92|19.03|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680402|NCT01243151|3091222|Superiority or Other||LS Mean Difference|11.2|Standard Error of the Mean|5.155||0.0339|2-Sided|95.0|0.88|21.52|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680403|NCT01243151|3091222|Superiority or Other||LS Mean Difference|13.52|Standard Error of the Mean|4.842||0.0071|2-Sided|95.0|3.83|23.22|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680404|NCT01243151|3091222|Superiority or Other||LS Mean Difference|1.95|Standard Error of the Mean|4.975||0.6965|2-Sided|95.0|-8.01|11.92|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680405|NCT01243151|3091222|Superiority or Other||LS Mean Difference|8.93|Standard Error of the Mean|4.94||0.0758|2-Sided|95.0|-0.96|18.83|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680406|NCT01243151|3091222|Superiority or Other||LS Mean Difference|9.64|Standard Error of the Mean|4.878||0.0531|2-Sided|95.0|-0.13|19.41|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680407|NCT01243151|3091222|Superiority or Other||LS Mean Difference|11.52|Standard Error of the Mean|6.249||0.0702|2-Sided|95.0|-0.98|24.03|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680408|NCT01243151|3091222|Superiority or Other||LS Mean Difference|7.57|Standard Error of the Mean|6.431||0.244|2-Sided|95.0|-5.3|20.44|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680409|NCT01243151|3091222|Superiority or Other||LS Mean Difference|11.13|Standard Error of the Mean|6.369||0.0858|2-Sided|95.0|-1.62|23.87|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680410|NCT01243151|3091222|Superiority or Other||LS Mean Difference|14.5|Standard Error of the Mean|6.214||0.0231|2-Sided|95.0|2.06|26.94|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680411|NCT01243151|3091222|Superiority or Other||LS Mean Difference|3.95|Standard Error of the Mean|5.174||0.448|2-Sided|95.0|-6.4|14.3|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680412|NCT01243151|3091222|Superiority or Other||LS Mean Difference|1.92|Standard Error of the Mean|5.225||0.7149|2-Sided|95.0|-8.54|12.37|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680413|NCT01243151|3091222|Superiority or Other||LS Mean Difference|6.05|Standard Error of the Mean|5.277||0.2563|2-Sided|95.0|-4.51|16.61|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680414|NCT01243151|3091222|Superiority or Other||LS Mean Difference|5.5|Standard Error of the Mean|5.131||0.2883|2-Sided|95.0|-4.77|15.77|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680415|NCT01243151|3091223|Superiority or Other||Odds Ratio (OR)|33.246||||0.0264|2-Sided|95.0|1.51|733.62|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680416|NCT01243151|3091223|Superiority or Other||Odds Ratio (OR)|47.86||||0.0159|2-Sided|95.0|2.07|1109.11|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680417|NCT01243151|3091223|Superiority or Other||Odds Ratio (OR)|17.375||||0.0732|2-Sided|95.0|0.76|394.65|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680418|NCT01243151|3091223|Superiority or Other||Odds Ratio (OR)|0.896||||0.958|2-Sided|95.0|0.02|52.79|||Regression, Logistic|||Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680419|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|258.938||||0.0021|2-Sided|95.0|7.53|8902.61|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680420|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|756.203||||0.002|2-Sided|95.0|11.18|51133.53|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680421|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|152.977||||0.0038|2-Sided|95.0|5.05|4633.92|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680422|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|6.158||||0.2751|2-Sided|95.0|0.24|161.08|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680423|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|224.427||||0.0017|2-Sided|95.0|7.63|6598.0|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680432|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|300.099||||0.0018|2-Sided|95.0|8.35|10787.45|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680433|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|129.984||||0.0047|2-Sided|95.0|4.44|3808.21|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680434|NCT01243151|3091224|Superiority or Other||Odds Ratio (OR)|353.058||||0.0013|2-Sided|95.0|9.95|12528.19|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680435|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|48.734||||0.0179|2-Sided|95.0|1.95|1216.9|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680436|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|57.766||||0.0142|2-Sided|95.0|2.26|1477.88|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680437|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|38.943||||0.0259|2-Sided|95.0|1.55|975.84|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680438|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|1.018||||0.9931|2-Sided|95.0|0.02|64.41|||Regression, Logistic|||Day 36: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680439|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|76.034||||0.0081|2-Sided|95.0|3.08|1875.15|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680440|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|89.341||||0.0069|2-Sided|95.0|3.43|2326.44|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680441|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|30.247||||0.0361|2-Sided|95.0|1.25|733.32|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680442|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|27.697||||0.0403|2-Sided|95.0|1.16|662.2|||Regression, Logistic|||Day 29: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680443|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|112.272||||0.0053|2-Sided|95.0|4.07|3097.22|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680444|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|87.733||||0.0084|2-Sided|95.0|3.14|2449.11|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680445|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|86.088||||0.0086|2-Sided|95.0|3.1|2389.27|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680446|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|74.273||||0.0105|2-Sided|95.0|2.74|2014.67|||Regression, Logistic|||Day 22: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680447|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|45.328||||0.0192|2-Sided|95.0|1.86|1103.73|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680448|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|47.527||||0.019|2-Sided|95.0|1.89|1198.29|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680449|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|11.815||||0.1368|2-Sided|95.0|0.46|305.54|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680450|NCT01243151|3091225|Superiority or Other||Odds Ratio (OR)|24.972||||0.0472|2-Sided|95.0|1.04|599.65|||Regression, Logistic|||Day 15: Logistic regression model with treatment and baseline LDL-C stratum as factors was used for the analysis.|
1680451|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-54.96|Standard Error of the Mean|5.701|<|0.0001|2-Sided|95.0|-66.38|-43.54|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680452|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-57.73|Standard Error of the Mean|5.891|<|0.0001|2-Sided|95.0|-69.53|-45.94|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680453|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-47.28|Standard Error of the Mean|5.881|<|0.0001|2-Sided|95.0|-59.06|-35.5|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680454|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-44.18|Standard Error of the Mean|5.8|<|0.0001|2-Sided|95.0|-55.8|-32.57|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680455|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-57.67|Standard Error of the Mean|5.413|<|0.0001|2-Sided|95.0|-68.53|-46.8|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680456|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-60.6|Standard Error of the Mean|5.59|<|0.0001|2-Sided|95.0|-71.81|-49.38|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1681201|NCT01235507|3092174|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 8|
1680457|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-53.92|Standard Error of the Mean|5.592|<|0.0001|2-Sided|95.0|-65.14|-42.7|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680458|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-49.67|Standard Error of the Mean|5.498|<|0.0001|2-Sided|95.0|-60.7|-38.64|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680459|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-53.45|Standard Error of the Mean|6.344|<|0.0001|2-Sided|95.0|-66.17|-40.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680460|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-56.35|Standard Error of the Mean|6.531|<|0.0001|2-Sided|95.0|-69.43|-43.27|||ANCOVA|||Day 15: Analysis was performed using ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680461|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-41.82|Standard Error of the Mean|6.527|<|0.0001|2-Sided|95.0|-54.9|-28.74|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680462|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-45.99|Standard Error of the Mean|6.384|<|0.0001|2-Sided|95.0|-58.78|-33.2|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680463|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-37.63|Standard Error of the Mean|5.051|<|0.0001|2-Sided|95.0|-47.75|-27.51|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680464|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-39.59|Standard Error of the Mean|5.143|<|0.0001|2-Sided|95.0|-49.89|-29.28|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680465|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-27.93|Standard Error of the Mean|5.202|<|0.0001|2-Sided|95.0|-38.35|-17.51|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680466|NCT01243151|3091226|Superiority or Other||LS Mean Difference|-33.82|Standard Error of the Mean|5.077|<|0.0001|2-Sided|95.0|-43.99|-23.65|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680467|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-89.58|Standard Error of the Mean|9.362|<|0.0001|2-Sided|95.0|-108.35|-70.81|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680468|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-93.78|Standard Error of the Mean|9.678|<|0.0001|2-Sided|95.0|-113.18|-74.38|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680469|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-76.01|Standard Error of the Mean|9.659|<|0.0001|2-Sided|95.0|-95.37|-56.65|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680470|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-71.41|Standard Error of the Mean|9.534|<|0.0001|2-Sided|95.0|-90.51|-52.3|||ANCOVA|||Day 29: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680471|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-92.33|Standard Error of the Mean|8.703|<|0.0001|2-Sided|95.0|-109.8|-74.86|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680472|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-96.08|Standard Error of the Mean|8.994|<|0.0001|2-Sided|95.0|-114.12|-78.03|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680473|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-84.45|Standard Error of the Mean|8.998|<|0.0001|2-Sided|95.0|-102.51|-66.4|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680474|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-78.47|Standard Error of the Mean|8.854|<|0.0001|2-Sided|95.0|-96.22|-60.71|||ANCOVA|||Day 22: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680475|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-84.65|Standard Error of the Mean|10.028|<|0.0001|2-Sided|95.0|-104.76|-64.54|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680476|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-88.69|Standard Error of the Mean|10.327|<|0.0001|2-Sided|95.0|-109.39|-68.0|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680477|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-63.89|Standard Error of the Mean|10.328|<|0.0001|2-Sided|95.0|-84.59|-43.19|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680478|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-72.16|Standard Error of the Mean|10.097|<|0.0001|2-Sided|95.0|-92.4|-51.92|||ANCOVA|||Day 15: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680479|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-61.75|Standard Error of the Mean|8.282|<|0.0001|2-Sided|95.0|-78.36|-45.15|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680480|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-64.44|Standard Error of the Mean|8.433|<|0.0001|2-Sided|95.0|-81.35|-47.53|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680481|NCT01243151|3091227|Superiority or Other||LS Mean Difference|-44.18|Standard Error of the Mean|8.53|<|0.0001|2-Sided|95.0|-61.28|-27.08|||ANCOVA|||Day 8: Analysis was performed using the ANCOVA treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680482|NCT01243151|3091227|Superiority or Other||Least Square (LS) Mean Difference|-54.68|Standard Error of the Mean|8.323|<|0.0001|2-Sided|95.0|-71.37|-37.99|||ANCOVA|||Day 8: Analysis was performed using the analysis of covariance (ANCOVA) treatment, screening LDL-C stratum, study day, treatment-by-LDL-C stratum, and study day by treatment interaction as fixed effects, baseline as a covariate and participant as a random effect.|
1680483|NCT01243112|3091242|Superiority or Other|||||||0.49|||||||ANOVA||||
1680484|NCT01243112|3091243|Superiority or Other|||||||0.359|||||||ANOVA|||Null Hypothesis is that no difference would be measured between treatment arms.|
1680485|NCT01242748|3091263|Superiority or Other||Hazard Ratio (HR)|0.595||||0.2212|2-Sided|95.0|0.259|1.368|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.|
1680486|NCT01242748|3091264|Superiority or Other||Hazard Ratio (HR)|0.739||||0.143|2-Sided|95.0|0.493|1.108|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.|
1680487|NCT01242748|3091265|Superiority or Other||Hazard Ratio (HR)|3.511||||0.0005|2-Sided|95.0|1.739|7.09|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.|
1680488|NCT01242748|3091266|Superiority or Other||Hazard Ratio (HR)|0.856|||||2-Sided|95.0|0.58|1.263||||||The hazard ratio was estimated using the Cox proportional hazard model.|
1680489|NCT01242748|3091267|Superiority or Other||Hazard Ratio (HR)|0.783||||0.1244|2-Sided|95.0|0.574|1.07|||Cox proportional hazard model|||The hazard ratio was estimated using the Cox proportional hazard model.|
1680490|NCT01242748|3091268|Non-Inferiority or Equivalence|Degarelix was considered to be non-inferior to goserelin with regard to the hazard ratio of PSA PFS failure rates as the upper limit of the two-sided 95% CI of the adjusted hazard ratio was less than the non-inferiority margin of 1.33.|Hazard Ratio (HR)|0.774||||0.1589|2-Sided|95.0|0.542|1.106|||Cox proportional hazard model|||The hazard ratio of PSA PFS failure rates was estimated using the Cox proportional hazard model with time to PSA PFS failure as dependent and treatment as independent variables and adjusted for baseline PSA category, prostate cancer stage, weight and geographical region. Degarelix was to be considered non-inferior to goserelin if the upper limit of the two-sided 95% confidence interval (CI) of the adjusted hazard ratio was less than or equal to the non-inferiority margin of 1.33.|
1680491|NCT01242527|3091269|Superiority or Other||Placebo adjusted % change from baseline|-26.6|||<|0.001|2-Sided|95.0|-45.12|-8.38||P-value adjusted with Dunnett’s procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors||
1680492|NCT01242527|3091269|Superiority or Other||Placebo adjusted % change from baseline|-21.19|||<|0.007|2-Sided|95.0|-40.32|-2.29||P-value adjusted with Dunnett’s procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors||
1680493|NCT01242527|3091269|Superiority or Other||Placebo adjusted % change from baseline|-21.68|||<|0.005|2-Sided|95.0|-40.7|-2.89||P-value adjusted with Dunnett’s procedure for multiple comparisons of Epanova vs olive oil|ANCOVA p-value on ranked data|ANCOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors|ANCOVA on log-scale TG with baseline value as covariate and treatment and user/non-user of lipid-altering drugs as factors||
1680494|NCT01242176|3091277|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.8|Standard Deviation|6.7|||2-Sided|90.0|98.26|105.48|||||Standard deviation is actually the gCV.|Ratio calculated as empa final formulation divided by empa trial formulation 2|
1680495|NCT01242176|3091278|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|99.46|Standard Deviation|18.7|||2-Sided|90.0|90.18|109.68|||||Standard deviation is actually the gCV.|Ratio calculated as empa final formulation divided by empa trial formulation 2|
1680496|NCT01242176|3091279|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric Mean Ratio|101.67|Standard Deviation|6.7|||2-Sided|90.0|98.1|105.37|||||Standard deviation is actually the geometric coefficient of variation (gCV).|Ratio calculated as empa final formulation divided by empa trial formulation 2|
1680497|NCT01241760|3091300|Non-Inferiority or Equivalence|If the lower limit of the 95% confidence interval of the difference in proportions was above the pre-determined non-inferiority margin of -11%, non-inferiority was established.|Difference in proportion of response, %|1.5||||||95.0|-4.9|12.0|||||Observed data||
1680498|NCT01241604|3091318|Equivalence|Equivalent non-parametric tests||||||0.753|||||||Wilcoxon signed ranks test||||
1680499|NCT01241591|3091363|Superiority or Other||Mean Difference|58.03|Standard Error of the Mean|3.46|||2-Sided|95.0|51.25|64.81||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.|
1680500|NCT01241591|3091363|Non-Inferiority or Equivalence|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 10 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%.|Mean Difference|4.83|Standard Error of the Mean|3.77|||2-Sided|95.0|-2.57|12.23||||||Difference from Etanercept (Active-Etanercept)|
1680501|NCT01241591|3091363|Superiority or Other||Mean Difference|33.91|Standard Error of the Mean|3.49|||2-Sided|95.0|27.06|40.76||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.|
1680502|NCT01241591|3091363|Non-Inferiority or Equivalence|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 5 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%, and CP-690,550 10 mg was superior to placebo for PGA and PASI75 response at Week 12.|Mean Difference|-19.29|Standard Error of the Mean|3.81|||2-Sided|95.0|-26.75|-11.83||||||Difference from Etanercept (Active-Etanercept)|
1680503|NCT01241591|3091364|Superiority or Other||Mean Difference|53.23|Standard Error of the Mean|4.3|||2-Sided|95.0|44.81|61.65||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 10 mg to placebo was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 10 mg was concluded to be non-inferior to etanercept.|
1680504|NCT01241591|3091364|Non-Inferiority or Equivalence|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 10 mg to etanercept was concluded if the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than -15%.|Mean Difference|1.91|Standard Error of the Mean|3.64|||2-Sided|95.0|-5.22|9.05||||||Difference from Etanercept (Active-Etanercept)|
1680505|NCT01241591|3091364|Superiority or Other||Mean Difference|32.16|Standard Error of the Mean|4.41|||2-Sided|95.0|23.51|40.81||||||Difference from Placebo (Active-Placebo); the a priori threshold for superiority was 0 and a step-down approach was used to adjust for multiple comparisons. Superiority of CP-690,550 5 mg to placebo was concluded if the lower bounds of the 95% LCIs of the difference for PGA and PASI75 responses at Week 12 were greater than 0, and non-inferiority of CP-690,550 5 mg was concluded to be non-inferior to etanercept.|
1680506|NCT01241591|3091364|Non-Inferiority or Equivalence|The a priori threshold for non-inferiority was -15% and a step-down approach was used to adjust for multiple comparisons. Non-inferiority of CP-690,550 5 mg to etanercept was concluded if the 95% lower confidence intervals (LCIs) of the difference for PGA and Psoriasis Area and Severity Index 75 (PASI75) responses at Week 12 were greater than -15%, and CP-690,550 10 mg was superior to placebo for PGA response and PASI75 at Week 12.|Mean Difference|-19.16|Standard Error of the Mean|3.77|||2-Sided|95.0|-26.55|-11.76||||||Difference from Etanercept (Active-Etanercept)|
1680507|NCT01241565|3091370|Superiority or Other||Rate of incidence of PAL|10.6|||||2-Sided|95.0|3.9|21.3|||||Incidence of Prolonged Air Leak (PAL) is estimated at between 5-10% in literature. PAL of 10%of evaluable cases was used to determine study success.||
1680508|NCT01241552|3091371|Superiority or Other||Percentage Difference|-16.7|||||2-Sided|95.0|-28.4|-4.7|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC||
1680509|NCT01241552|3091371|Superiority or Other||Percentage Difference|-11.0|||||2-Sided|95.0|-23.2|1.4|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC||
1680510|NCT01241552|3091371|Superiority or Other||Percentage Difference|-10.1|||||2-Sided|95.0|-23.2|4.6|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC||
1680511|NCT01241552|3091372|Superiority or Other||Percentage Difference|-16.0|||||2-Sided|95.0|-27.8|-4.0|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC||
1680512|NCT01241552|3091372|Superiority or Other||Percentage Difference|-12.7|||||2-Sided|95.0|-24.7|-0.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC||
1680513|NCT01241552|3091372|Superiority or Other||Percentage Difference|-11.3|||||2-Sided|95.0|-24.9|3.9|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC||
1680514|NCT01241552|3091373|Superiority or Other||Percentage Difference|-25.3|||||2-Sided|95.0|-43.7|-6.1|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC||
1680515|NCT01241552|3091373|Superiority or Other||Percentage Difference|-10.0|||||2-Sided|95.0|-30.1|10.0|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC||
1680516|NCT01241552|3091374|Superiority or Other||Percentage Difference|-12.1|||||2-Sided|95.0|-26.2|1.9|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC||
1680517|NCT01241552|3091374|Superiority or Other||Percentage Difference|-14.6|||||2-Sided|95.0|-28.3|-1.4|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC||
1680518|NCT01241552|3091374|Superiority or Other||Percentage Difference|0.8|||||2-Sided|95.0|-16.9|21.0|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC||
1680519|NCT01241552|3091375|Superiority or Other||Percentage Difference|-14.4|||||2-Sided|95.0|-26.8|-1.6|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC||
1680520|NCT01241552|3091375|Superiority or Other||Percentage Difference|-13.2|||||2-Sided|95.0|-25.5|-0.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC||
1680521|NCT01241552|3091375|Superiority or Other||Percentage Difference|-6.1|||||2-Sided|95.0|-20.1|8.6|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC||
1680523|NCT01241552|3091376|Superiority or Other||Percentage Difference|-18.0|||||2-Sided|95.0|-26.3|-9.6|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC||
1680524|NCT01241552|3091376|Superiority or Other||Percentage Difference|-6.9|||||2-Sided|95.0|-16.8|3.5|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC||
1680525|NCT01241552|3091377|Superiority or Other||Percentage Difference|1.3|||||2-Sided|95.0|-2.6|5.2|||||Percentage Difference: MK-3415A + SOC - Placebo + SOC||
1680526|NCT01241552|3091377|Superiority or Other||Percentage Difference|4.3|||||2-Sided|95.0|0.2|8.5|||||Percentage Difference: MK-6072 + SOC - Placebo + SOC||
1680527|NCT01241552|3091377|Superiority or Other||Percentage Difference|3.6|||||2-Sided|95.0|-1.0|8.7|||||Percentage Difference: MK-3415 + SOC - Placebo + SOC||
1680528|NCT01241552|3091378|Superiority or Other||Percentage Difference|0.0|||>|0.999|2-Sided|95.0|-1.0|1.0|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC||
1680529|NCT01241552|3091378|Superiority or Other||Percentage Difference|0.3|||>|0.311|2-Sided|95.0|-0.7|1.4|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC||
1680530|NCT01241552|3091378|Superiority or Other||Percentage Difference|0.4|||>|0.192|2-Sided|95.0|-0.5|2.4|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC||
1680531|NCT01241552|3091379|Superiority or Other||Percentage Difference|0.3||||0.544|2-Sided|95.0|-0.9|1.6|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placeb + SOC||
1680532|NCT01241552|3091379|Superiority or Other||Percentage Difference|0.8||||0.17|2-Sided|95.0|-0.5|2.4|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC||
1680533|NCT01241552|3091379|Superiority or Other||Percentage Difference|1.0||||0.115|2-Sided|95.0|-0.3|3.5|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC||
1680534|NCT01241552|3091380|Superiority or Other||Percentage Difference|-5.3||||0.051|2-Sided|95.0|-10.6|0.0|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC||
1680535|NCT01241552|3091380|Superiority or Other||Percentage Difference|1.5||||0.594|2-Sided|95.0|-4.1|7.2|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC||
1680536|NCT01241552|3091380|Superiority or Other||Percentage Difference|7.7||||0.027|2-Sided|95.0|0.9|14.7|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC||
1680537|NCT01241552|3091381|Superiority or Other||Percentage Difference|1.2||||0.464|2-Sided|95.0|-2.1|4.6|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC||
1680538|NCT01241552|3091381|Superiority or Other||Percentage Difference|3.2||||0.069|2-Sided|95.0|-0.3|6.8|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC||
1680539|NCT01241552|3091381|Superiority or Other||Percentage Difference|2.2||||0.246|2-Sided|95.0|-1.5|6.7|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC||
1680540|NCT01241552|3091382|Superiority or Other||Percentage Difference|-2.3||||0.507|2-Sided|95.0|-9.1|4.5|||Miettinen and Nurminen||Percentage Difference: MK-3415A + SOC - Placebo + SOC||
1680541|NCT01241552|3091382|Superiority or Other||Percentage Difference|3.4||||0.323|2-Sided|95.0|-3.3|10.1|||Miettinen and Nurminen||Percentage Difference: MK-6072 + SOC - Placebo + SOC||
1680542|NCT01241552|3091382|Superiority or Other||Percentage Difference|5.2||||0.185|2-Sided|95.0|-2.5|12.8|||Miettinen and Nurminen||Percentage Difference: MK-3415 + SOC - Placebo + SOC||
1680543|NCT01241552|3091383|Superiority or Other||Adjusted Difference|-1.0||||0.3906|2-Sided|95.0|-7.7|5.8||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC||
1680544|NCT01241552|3091383|Superiority or Other||Adjusted Difference|-13.7||||0.0007|2-Sided|95.0|-22.5|-5.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC||
1680545|NCT01241552|3091383|Superiority or Other||Adjusted Difference|-11.7||||0.0006|2-Sided|95.0|-18.6|-4.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC||
1680546|NCT01241552|3091383|Superiority or Other||Adjusted Difference|-10.8||||0.0013|2-Sided|95.0|-17.7|-3.8||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC||
1680547|NCT01241552|3091383|Superiority or Other||Adjusted Difference|1.7||||0.6505|2-Sided|95.0|-6.9|10.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC||
1680548|NCT01241552|3091384|Superiority or Other||Adjusted Difference|-1.4||||0.6532|2-Sided|95.0|-8.3|5.5||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC||
1680549|NCT01241552|3091384|Superiority or Other||Adjusted Difference|11.7||||0.0025|2-Sided|95.0|3.5|19.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC||
1680550|NCT01241552|3091384|Superiority or Other||Adjusted Difference|3.5||||0.1646|2-Sided|95.0|-3.5|10.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC||
1680574|NCT01240915|3091441|Superiority or Other||Mean Difference (Final Values)|0.43|Standard Error of the Mean|0.635||0.75|2-Sided|80.0|-0.39|1.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)|
1680551|NCT01241552|3091384|Superiority or Other||Adjusted Difference|4.8||||0.0861|2-Sided|95.0|-2.1|11.7||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC||
1680552|NCT01241552|3091384|Superiority or Other||Adjusted Difference|-8.3||||0.9775|2-Sided|95.0|-16.3|-0.2||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC||
1680553|NCT01241552|3091385|Superiority or Other||Adjusted Difference|-1.4||||0.2997|2-Sided|95.0|-6.7|3.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-6072 + SOC||
1680554|NCT01241552|3091385|Superiority or Other||Adjusted Difference|-9.9||||0.0013|2-Sided|95.0|-16.9|-3.4||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - MK-3415 + SOC||
1680555|NCT01241552|3091385|Superiority or Other||Adjusted Difference|-11.6|||<|0.0001|2-Sided|95.0|-17.4|-5.9||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415A + SOC - Placebo + SOC||
1680556|NCT01241552|3091385|Superiority or Other||Adjusted Difference|-10.1|||<|0.0003|2-Sided|95.0|-15.9|-4.3||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-6072 + SOC - Placebo + SOC||
1680557|NCT01241552|3091385|Superiority or Other||Adjusted Difference|-1.7|||<|0.3182|2-Sided|95.0|-8.6|5.5||One sided p-value based on the Miettinen and Nurminen method stratified by SOC therapy (metronidazole vs. vancomycin vs. fidaxomicin) and hospitalization status (inpatient vs. outpatient).|Miettinen and Nurminen||Adjusted Difference: MK-3415 + SOC - Placebo + SOC||
1680558|NCT01241448|3091415|Superiority or Other||Least Squares Mean Difference|-0.77|||<|0.01|2-Sided|90.0|-1.05|-0.48||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).|
1680559|NCT01241448|3091415|Superiority or Other||Least Squares Mean Difference|-0.62|||<|0.001|2-Sided|90.0|-0.9|-0.34||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).|
1680560|NCT01241448|3091415|Superiority or Other||Least Squares Mean Difference|-0.29|||<|0.094|2-Sided|90.0|-0.58|-0.01||No multiplicity adjustments were used to calculate the p-value.|Mixed Models Analysis|||Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).|
1680561|NCT01241318|3091422|Superiority or Other (legacy)||Risk Ratio (RR)|0.73|||||2-Sided|95.0|0.47|1.13|||||Generalized estimating equation models adjusting for cluster-randomized design were used.||
1680562|NCT01241318|3091423|Superiority or Other (legacy)||Risk Ratio (RR)|1.12|||||2-Sided|95.0|0.86|1.47|||||Generalized estimating equation models adjusting for cluster-randomized design were used.||
1680563|NCT01241318|3091424|Superiority or Other (legacy)||Risk Ratio (RR)|1.12|||||2-Sided|95.0|0.88|1.44|||||The chlorhexidine arm is the numerator and dry cord care arm is the denomiator in the relative risk calculation. Generalised estimating equation models were used to adjust for cluster randomized design.||
1680564|NCT01240915|3091439|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.25||0.31|2-Sided|80.0|-0.45|0.2||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)|
1680565|NCT01240915|3091439|Superiority or Other||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.231||0.18|2-Sided|80.0|-0.51|0.09||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)|
1680566|NCT01240915|3091439|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.234||0.56|2-Sided|80.0|-0.26|0.34||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)|
1680567|NCT01240915|3091439|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.226||0.36|2-Sided|80.0|-0.37|0.21||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)|
1680568|NCT01240915|3091439|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.209||0.74|2-Sided|80.0|-0.14|0.4||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)|
1680569|NCT01240915|3091439|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.213||0.29|2-Sided|80.0|-0.39|0.16||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)|
1680570|NCT01240915|3091439|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.158||0.62|2-Sided|80.0|-0.16|0.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)|
1680571|NCT01240915|3091439|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.144||0.51|2-Sided|80.0|-0.18|0.19||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)|
1680572|NCT01240915|3091440|Superiority or Other||Mean Difference (Final Values)|0.52|Standard Error of the Mean|0.753||0.75|2-Sided|80.0|-0.46|1.49||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo|
1680573|NCT01240915|3091441|Superiority or Other||Mean Difference (Final Values)|0.73|Standard Error of the Mean|0.692||0.85|2-Sided|80.0|-0.16|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)|
1680575|NCT01240915|3091441|Superiority or Other||Mean Difference (Final Values)|1.21|Standard Error of the Mean|0.656||0.97|2-Sided|80.0|0.37|2.06||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)|
1680576|NCT01240915|3091441|Superiority or Other||Mean Difference (Final Values)|0.42|Standard Error of the Mean|0.705||0.72|2-Sided|80.0|-0.5|1.33||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)|
1680577|NCT01240915|3091441|Superiority or Other||Mean Difference (Final Values)|0.76|Standard Error of the Mean|0.645||0.88|2-Sided|80.0|-0.08|1.59||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)|
1680578|NCT01240915|3091441|Superiority or Other||Mean Difference (Final Values)|0.44|Standard Error of the Mean|0.666||0.74|2-Sided|80.0|-0.42|1.3||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)|
1680579|NCT01240915|3091441|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.418||0.77|2-Sided|80.0|-0.23|0.84||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)|
1680580|NCT01240915|3091441|Superiority or Other||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.345||0.8|2-Sided|80.0|-0.15|0.74||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)|
1680581|NCT01240915|3091442|Superiority or Other||Mean Difference (Final Values)|0.58|Standard Error of the Mean|0.513||0.87|2-Sided|80.0|-0.08|1.24||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo|
1680582|NCT01240915|3091443|Superiority or Other||Odds Ratio (OR)|0.3||||0.96|2-Sided|80.0|0.12|0.73||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo|
1680583|NCT01240915|3091444|Superiority or Other||Odds Ratio (OR)|0.49||||0.84|2-Sided|80.0|0.2|1.24||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo|
1680584|NCT01240915|3091445|Superiority or Other||Odds Ratio (OR)|0.53||||0.81|2-Sided|80.0|0.22|1.32||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 16)|
1680585|NCT01240915|3091445|Superiority or Other||Odds Ratio (OR)|1.58||||0.24|2-Sided|80.0|0.7|3.57||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 16)|
1680586|NCT01240915|3091445|Superiority or Other||Odds Ratio (OR)|1.05||||0.47|2-Sided|80.0|0.45|2.42||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 16)|
1680587|NCT01240915|3091445|Superiority or Other||Odds Ratio (OR)|0.38||||0.89|2-Sided|80.0|0.14|1.04||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 12)|
1680588|NCT01240915|3091445|Superiority or Other||Odds Ratio (OR)|1.23||||0.38|2-Sided|80.0|0.5|3.04||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 12)|
1680589|NCT01240915|3091445|Superiority or Other||Odds Ratio (OR)|1.11||||0.44|2-Sided|80.0|0.45|2.76||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 12)|
1680590|NCT01240915|3091445|Superiority or Other||Odds Ratio (OR)|1.09||||0.43|2-Sided|80.0|0.61|1.95||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 8)|
1680591|NCT01240915|3091445|Superiority or Other||Odds Ratio (OR)|2.27||||0.05|2-Sided|80.0|1.21|4.24||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 4)|
1680592|NCT01240915|3091446|Superiority or Other||Odds Ratio (OR)|0.39||||0.85|2-Sided|80.0|0.12|1.23||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo|
1680593|NCT01240915|3091447|Superiority or Other||Odds Ratio (OR)|0.83||||0.57|2-Sided|80.0|0.22|3.07||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo|
1680594|NCT01240915|3091448|Superiority or Other||Odds Ratio (OR)|0.51||||0.84|2-Sided|80.0|0.21|1.23||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 16)|
1680595|NCT01240915|3091448|Superiority or Other||Odds Ratio (OR)|0.74||||0.68|2-Sided|80.0|0.33|1.66||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 16)|
1680596|NCT01240915|3091448|Superiority or Other||Odds Ratio (OR)|0.88||||0.58|2-Sided|80.0|0.38|2.03||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 16)|
1680597|NCT01240915|3091448|Superiority or Other||Odds Ratio (OR)|1.04||||0.48|2-Sided|80.0|0.41|2.64||1-sided p-value|Regression, Logistic|||Cohort 3 PM versus Cohort 3 PP (Week 12)|
1680598|NCT01240915|3091448|Superiority or Other||Odds Ratio (OR)|0.66||||0.74|2-Sided|80.0|0.28|1.55||1-sided p-value|Regression, Logistic|||Cohort 3 MP versus Cohort 3 PP (Week 12)|
1680599|NCT01240915|3091448|Superiority or Other||Odds Ratio (OR)|2.37||||0.1|2-Sided|80.0|0.99|5.67||1-sided p-value|Regression, Logistic|||Cohort 3 MM versus Cohort 3 PP (Week 12)|
1680600|NCT01240915|3091448|Superiority or Other||Odds Ratio (OR)|1.23||||0.33|2-Sided|80.0|0.68|2.23||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 8)|
1680601|NCT01240915|3091448|Superiority or Other||Odds Ratio (OR)|1.21||||0.34|2-Sided|80.0|0.66|2.19||1-sided p-value|Regression, Logistic|||Pooled MultiStem versus Pooled Placebo (Week 4)|
1680602|NCT01240915|3091449|Superiority or Other||Geometric Mean Ratio|1.51||||0.89|2-Sided|80.0|0.98|2.32||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)|
1680603|NCT01240915|3091449|Superiority or Other||Geometric Mean Ratio|1.1||||0.62|2-Sided|80.0|0.74|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)|
1680604|NCT01240915|3091449|Superiority or Other||Geometric Mean Ratio|2.3||||0.99|2-Sided|80.0|1.52|3.48||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)|
1680605|NCT01240915|3091449|Superiority or Other||Geometric Mean Ratio|1.98||||0.95|2-Sided|80.0|1.15|3.41||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)|
1680606|NCT01240915|3091449|Superiority or Other||Geometric Mean Ratio|1.96||||0.96|2-Sided|80.0|1.19|3.25||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)|
1680607|NCT01240915|3091449|Superiority or Other||Geometric Mean Ratio|2.75||||0.99|2-Sided|80.0|1.63|4.64||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)|
1680608|NCT01240915|3091449|Superiority or Other||Geometric Mean Ratio|1.21||||0.8|2-Sided|80.0|0.9|1.63||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)|
1680609|NCT01240915|3091449|Superiority or Other||Geometric Mean Ratio|1.17||||0.79|2-Sided|80.0|0.91|1.51||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)|
1680610|NCT01240915|3091450|Superiority or Other||Geometric Mean Ratio|0.81||||0.3|2-Sided|80.0|0.49|1.36||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 16)|
1680611|NCT01240915|3091450|Superiority or Other||Geometric Mean Ratio|0.95||||0.95|2-Sided|80.0|0.58|1.57||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 16)|
1680612|NCT01240915|3091450|Superiority or Other||Geometric Mean Ratio|1.12||||0.62|2-Sided|80.0|0.68|1.84||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 16)|
1680613|NCT01240915|3091450|Superiority or Other||Geometric Mean Ratio|1.18||||0.67|2-Sided|80.0|0.72|1.94||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 PM versus Cohort 3 PP (Week 12)|
1680614|NCT01240915|3091450|Superiority or Other||Geometric Mean Ratio|0.94||||0.44|2-Sided|80.0|0.59|1.51||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MP versus Cohort 3 PP (Week 12)|
1680615|NCT01240915|3091450|Superiority or Other||Geometric Mean Ratio|1.38||||0.81|2-Sided|80.0|0.86|2.23||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Cohort 3 MM versus Cohort 3 PP (Week 12)|
1680616|NCT01240915|3091450|Superiority or Other||Geometric Mean Ratio|1.48||||0.91|2-Sided|80.0|1.02|2.14||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 8)|
1680617|NCT01240915|3091450|Superiority or Other||Geometric Mean Ratio|1.02||||0.53|2-Sided|80.0|0.73|1.42||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 16||Pooled MultiStem versus Pooled Placebo (Week 4)|
1680618|NCT01240915|3091457|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.174||0.67|2-Sided|80.0|-0.15|0.3||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 8||Pooled MultiStem versus Pooled Placebo (Week 8)|
1680619|NCT01240915|3091458|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.161||0.54|2-Sided|80.0|-0.19|0.22||1-sided p-value|Mixed Models Analysis|MMRM using data up to Week 8||Pooled MultiStem versus Pooled Placebo (Week 4)|
1680620|NCT01240915|3091459|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.223||0.96|2-Sided|80.0|0.12|0.69||1-sided p-value|ANCOVA|||Pooled MultiStem versus Pooled Placebo|
1680621|NCT01240902|3091469|Non-Inferiority or Equivalence (legacy)|Non-inferiority margin 15|||||<|0.0001||||||Hierarchical test item #1|t-test, 1 sided|||"Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level of 0.05 the hypotheses: H0: μ MCS TAVR ≤ μ SAVR -15 HA: μ MCS TAVR > μ SAVR -15 In the above expression μ MCS TAVR and μ SAVR denoted the mean improvements in mean gradient from Baseline to 1 year measured in mmHg."|
1680622|NCT01240902|3091469|Superiority or Other (legacy)||||||<|0.0001||||||Hierarchical test item #1|t-test, 2 sided|||"Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero."|
1680623|NCT01240902|3091470|Non-Inferiority or Equivalence (legacy)|Non-inferiority margin 0.375|||||<|0.0001||||||Hierarchical test item #2|t-test, 1 sided|||"EOA:~Change in effective orifice area from Baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR > µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in effective orifice area from Baseline to 1 year measured in cm2."|
1680624|NCT01240902|3091470|Superiority or Other (legacy)||||||<|0.0001||||||Hierarchical test item #2|t-test, 2 sided|||"EOA:~Change in effective orifice area from Baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero."|
1680625|NCT01240902|3091471|Superiority or Other (legacy)||||||<|0.0001||||||Hierarchical test item #6. Item #5 failed, therefore, item #6 also fails. Nominal p- value provided.|t-test, 2 sided|||"Change in SF-12 Physical Summary Scale from baseline to 30 days: TAVR vs. SAVR from secondary objective #8. The two-sided two-sample t-test was used to test at a level 0.05 the hypotheses:~H0: µ MCS TAVR = µ SAVR HA: µ MCS TAVR ≠ µ SAVR In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the SF-12 Physical Summary Scale from baseline to 30 days."|
1680626|NCT01240902|3091471|Non-Inferiority or Equivalence (legacy)|Non-inferiority margin 5|||||<|0.0063||||||Hierarchical test item #4|t-test, 1 sided|||"Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year: TAVR vs. SAVR from secondary objective #8. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -5 HA: µ MCS TAVR > µ SAVR -5 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the KCCQ score from baseline to 1 year."|
1680627|NCT01240902|3091471|Superiority or Other (legacy)||||||<|0.0001||||||Hierarchical test item #4|t-test, 2 sided|||Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year from secondary objective #8. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.|
1680628|NCT01240902|3091474|Non-Inferiority or Equivalence (legacy)|Non-inferiority margin= 0.375. For subjects with NYHA categories at both baseline and 1 year visit, the NYHA classification improvements were calculated as NYHAbaseline – NYHA1year.|||||<|0.0001||||||Hierarchical test item #3, change from baseline to 1 year.|t-test, 1 sided|||"Change in NYHA classification from baseline to 1 year: TAVR vs. SAVR from secondary objective #5. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR > µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean number of classification improvements in NYHA from baseline to 1 year."|
1681202|NCT01235507|3092175|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 24|
1680629|NCT01240902|3091474|Superiority or Other (legacy)||Mean Difference (Net)|-1.6|Standard Deviation|0.9|<|0.0001|2-Sided|||||Hierarchical test item #3, change from baseline to 1 year.|t-test, 2 sided|||Change in NYHA classification from baseline to 1 year from secondary objective #5. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.|
1680630|NCT01240902|3091478|Superiority or Other (legacy)|||||||0.1033||||||Hierarchical test item #5, MACCE at 30 days or hospital discharge; whichever was longer. K-M rates TAVR 8.21%, SAVR 10.93%, Difference -2.73%, Standard Error 2.16%, and Upper 95% CI 1.5%.|Kaplan-Meier Point Estimate|Using Greenwood formula||"Powered Secondary Hypothesis: TAVR with the Medtronic CoreValve System was superior to SAVR in binary rate of MACCE at 30 days or hospital discharge, whichever was longer:~H0: πMCS TAVR = πSAVR HA: πMCS TAVR < πSAVR In the above expression πMCS TAVR and πSAVR denoted rates of MACCE at 30 days or hospital discharge, whichever was longer.~Assumptions:~1:1 treatment allocation ratio One-sided alpha=0.025 SAVR = 20.0% MCS TAVI = 12.1% Power = >80%"|
1680631|NCT01240902|3091479|Non-Inferiority or Equivalence (legacy)|The 12 month all-cause mortality estimated rate was 20% for each group with a noninferiority margin of 7.5 percentage points. Assuming a 1:1 ratio in the treatment assignments, we estimated that a total of 355 patients were required in each group for the study to have power of 80% at a one-sided alpha level of 0.05. Accounting for a 10% loss to follow-up, we calculated that we would need to enroll 790 patients.|||||<|0.0001|||||||z-test, 1 sided||||
1680632|NCT01240902|3091479|Superiority or Other (legacy)||Kaplan-Meier|39.3|Standard Error of the Mean|4.0|<||2-Sided||||||||Kaplan-Meier Event Rate Greenwood Standard Error|No performance goal created, only descriptive statistics are provided.|
1680633|NCT01240902|3091479|Superiority or Other (legacy)||Kaplan-Meier|26.0|Standard Error of the Mean|2.0|<|0.0001|2-Sided|95.0|22.3|30.1|||z-test, 1 sided||Kaplan-Meier Event Rate Greenwood Standard Error|TAVR with the Medtronic CoreValve System meets the Performance Goal in the 12 month rate of all-cause mortality or major stroke H0: = πMCS TAVI ≥ 43.0% HA: = πMCS TAVI < 43.0% In the above expressions πMCS TAVI denotes the rate of all-cause mortality or major stroke during a fixed follow-up of 1 year.|
1680634|NCT01240863|3091505|Superiority or Other||Mean Difference (Final Values)|0.35||||0.134|2-Sided|95.0|-0.11|0.82||statistical significance level of 0.05.|ANCOVA|Treatment and stratification (opioid naïve/opioid experienced) factors as the fixed effects; screening and baseline APIs as covariates.|placebo - hydrocodone||
1680635|NCT01240811|3091506|Superiority|||||||0.62|||||||Kruskal-Wallis|||Change in quantity of Garnerella vaginalis species by qPCR|
1680636|NCT01240811|3091506|Superiority|||||||0.46|||||||Kruskal-Wallis|||Change in quantity of H2O2 producing Lactobacilli species by qPCR|
1680637|NCT01240811|3091507|Superiority|||||||0.08|||||||Kruskal-Wallis|||Difference in paired change in Nugent score from baseline to 2 months|
1680638|NCT01240811|3091508|Superiority or Other|||||||0.97|||||||ANOVA||||
1680639|NCT01240811|3091508|Superiority or Other|||||||0.8|||||||ANOVA||||
1680640|NCT01240382|3091545|Superiority or Other||Median Difference (Final Values)|-0.67||||0.01||95.0|-1.18|-0.67|||t-test, 2 sided||||
1680641|NCT01240382|3091546|Non-Inferiority or Equivalence|Non-inferiority in mean change in fluorescein staining score from baseline was assessed on the non-inferiority margin (0.34) with the upper limit of the confidence interval of the difference between the 2 treatment groups.|Median Difference (Final Values)|-0.03||||||95.0|-0.405|0.338|||||||
1680642|NCT01240330|3091556|Superiority or Other||Mean Difference (Final Values)|18.9|Standard Deviation|7.46|<|0.0001|2-Sided|95.0|16.3|21.59|||t-test, 1 sided|||The femoral venous peak flow velocity (PFV) compared to the subject's own resting baseline PFV.|
1680643|NCT01239797|3091575|Superiority or Other||Difference in Percentage|12.7|||||2-Sided|95.0|6.2|19.3||||||Difference of Lenalidomide + Dexamethasone + Elotuzumab minus Lenalidomide + Dexamethasone computed using the method of DerSimonian and Laird (weighted average over the strata)|
1680644|NCT01239797|3091575|Superiority or Other||Odds Ratio (OR)|1.95||||0.0002|2-Sided|95.0|1.36|2.78|||Cochran-Mantel-Haenszel|Stratified by B2 microglobulin (<3.5 mg/L vs >=3.5 mg/L), number of prior lines of therapy (1 vs >=2), and immunomodulatory drug use at randomization||Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone|
1680645|NCT01239797|3091576|Superiority or Other||Hazard Ratio (HR)|0.73||||0.0014|2-Sided|95.0|0.6|0.89|||Log Rank|2-sided p-value for stratified log rank test||Hazard Ratio of Lenalidomide + Dexamethasone + Elotuzumab to Lenalidomide + Dexamethasone|
1680646|NCT01239472|3091603|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1680647|NCT01239472|3091604|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1680648|NCT01239121|3091639|Superiority or Other||Odds Ratio (OR)|1.0||||0.964|2-Sided|95.0|0.49|2.1|||Regression, Logistic||||
1680649|NCT01239121|3091640|Superiority or Other||Slope|0.6||||0.175|2-Sided|95.0|-0.27|1.5|||Regression, Linear||||
1680650|NCT01238861|3091665|Superiority or Other|||||||0.667|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680651|NCT01238861|3091665|Superiority or Other|||||||0.944|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680652|NCT01238861|3091665|Superiority or Other|||||||0.896|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680653|NCT01238861|3091666|Superiority or Other||Mean Difference (Final Values)|3.54||||0.413|2-Sided|80.0|-2.006|9.086|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680654|NCT01238861|3091666|Superiority or Other||Mean Difference (Final Values)|7.659||||0.215|2-Sided|80.0|-0.262|15.579|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680655|NCT01238861|3091666|Superiority or Other||Mean Difference (Final Values)|3.907||||0.55|2-Sided|80.0|-4.483|12.297|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680656|NCT01238861|3091667|Superiority or Other||Mean Difference (Final Values)|1.139||||0.503|2-Sided|80.0|-1.041|3.319|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680657|NCT01238861|3091667|Superiority or Other||Mean Difference (Final Values)|2.857||||0.227|2-Sided|80.0|-0.175|5.889|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680658|NCT01238861|3091667|Superiority or Other||Mean Difference (Final Values)|-0.373||||0.871|2-Sided|80.0|-3.333|2.586|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680659|NCT01238861|3091668|Superiority or Other||Mean Difference (Final Values)|0.011||||0.599|2-Sided|80.0|-0.016|0.038|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680660|NCT01238861|3091668|Superiority or Other||Mean Difference (Final Values)|0.041||||0.113|2-Sided|80.0|0.008|0.074|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680661|NCT01238861|3091668|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.51|2-Sided|80.0|-0.058|0.019|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680662|NCT01238861|3091669|Superiority or Other||Mean Difference (Final Values)|0.238||||0.168|2-Sided|80.0|0.017|0.459|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680663|NCT01238861|3091669|Superiority or Other||Mean Difference (Final Values)|0.462||||0.049|2-Sided|80.0|0.163|0.761|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680664|NCT01238861|3091669|Superiority or Other||Mean Difference (Final Values)|0.404||||0.069|2-Sided|80.0|0.121|0.687|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680665|NCT01238861|3091671|Superiority or Other|||||||0.129|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680666|NCT01238861|3091671|Superiority or Other|||||||0.134|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680667|NCT01238861|3091671|Superiority or Other|||||||0.092|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680668|NCT01238861|3091671|Superiority or Other|||||||0.384|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680669|NCT01238861|3091672|Superiority or Other||Mean Difference (Final Values)|0.091||||0.026|2-Sided|80.0|0.039|0.143|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680670|NCT01238861|3091672|Superiority or Other||Mean Difference (Final Values)|0.184||||0.004|2-Sided|80.0|0.102|0.266|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680671|NCT01238861|3091672|Superiority or Other||Mean Difference (Final Values)|0.157||||0.014|2-Sided|80.0|0.076|0.237|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680672|NCT01238861|3091673|Superiority or Other||Mean Difference (Final Values)|0.15||||0.645|2-Sided|80.0|-0.267|0.567|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.|
1680673|NCT01238861|3091673|Superiority or Other||Mean Difference (Final Values)|0.337||||0.624|2-Sided|80.0|-0.548|1.222|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.|
1680674|NCT01238861|3091673|Superiority or Other||Mean Difference (Final Values)|-0.004||||0.992|2-Sided|80.0|-0.602|0.593|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use with prophylactic at Week 51-52.|
1680675|NCT01238861|3091673|Superiority or Other||Mean Difference (Final Values)|0.029||||0.91|2-Sided|80.0|-0.297|0.355|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.|
1680676|NCT01238861|3091673|Superiority or Other||Mean Difference (Final Values)|0.111||||0.824|2-Sided|80.0|-0.533|0.756|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.|
1680677|NCT01238861|3091673|Superiority or Other||Mean Difference (Final Values)|-0.174||||0.642|2-Sided|80.0|-0.654|0.306|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.||Analysis reported for rescue medication use without prophylactic at Week 51-52.|
1680678|NCT01238861|3091674|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.097|2-Sided|80.0|-0.247|-0.032|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680679|NCT01238861|3091674|Superiority or Other||Mean Difference (Final Values)|-0.173||||0.126|2-Sided|80.0|-0.317|-0.028|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680680|NCT01238861|3091674|Superiority or Other||Mean Difference (Final Values)|-0.182||||0.131|2-Sided|80.0|-0.336|-0.028|||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680681|NCT01238861|3091676|Superiority or Other|||||||0.01|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680682|NCT01238861|3091676|Superiority or Other|||||||0.057|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680683|NCT01238861|3091676|Superiority or Other|||||||0.074|||||||ANCOVA|P-value was calculated by ANCOVA with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680684|NCT01238861|3091676|Superiority or Other|||||||0.125|||||||ANCOVA|P-value was calculated by analysis of covariance (ANCOVA) with treatment, baseline inhaled steroid status and baseline observed value as covariates.|||
1680685|NCT01238861|3091681|Superiority or Other||Rate ratio|0.59||||0.096|2-Sided|80.0|0.4|0.89|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.||
1680686|NCT01238861|3091681|Superiority or Other||Rate Ratio|0.64||||0.173|2-Sided|80.0|0.42|0.97|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.||
1680687|NCT01238861|3091681|Superiority or Other||Rate Ratio|1.09||||0.781|2-Sided|80.0|0.74|1.59|||Poisson Regression Method||The p-value was calculated by Poisson regression with over-dispersion adjustment factor. The correction for potential over dispersion was made by Pearson chi-square.||
1680688|NCT01238172|3091744|Superiority||||||<|0.001|||||||t-test, 2 sided|Two-sided|||
1680689|NCT01238172|3091745|Superiority|||||||0.995|||||||Wilcoxon (Mann-Whitney)||||
1680690|NCT01238172|3091746|Superiority||Hazard Ratio (HR)|1.41||||0.71|2-Sided|95.0|0.23|8.41|||Log Rank||||
1680691|NCT01238172|3091747|Superiority||Hazard Ratio (HR)|0.96||||0.76|2-Sided|95.0|0.75|1.24|||Log Rank||||
1680692|NCT01237587|3091813|Superiority||Mean Difference (Final Values)|-1.21||||0.54|2-Sided|95.0|-5.12|2.69|||ANCOVA|||Total Score|
1680693|NCT01237587|3091813|Superiority||Mean Difference (Final Values)|-0.19||||0.7|2-Sided|95.0|-1.17|0.79|||ANCOVA|||Separation/Panic|
1680694|NCT01237587|3091813|Superiority||Mean Difference (Final Values)|-0.43||||0.486|2-Sided|95.0|-1.66|0.79|||ANCOVA|||Social Anxiety|
1680695|NCT01237587|3091813|Superiority||Mean Difference (Final Values)|-0.56||||0.381|2-Sided|95.0|-1.82|0.7|||ANCOVA|||Harm Avoidance|
1680696|NCT01237587|3091813|Superiority||Mean Difference (Final Values)|0.05||||0.955|2-Sided|95.0|-1.59|1.68|||ANCOVA|||Physical Symptoms Score|
1680697|NCT01237587|3091814|Superiority||Mean Difference (Final Values)|-0.83||||0.335|2-Sided|95.0|-2.52|0.86|||ANCOVA||||
1680698|NCT01237587|3091815|Superiority||Mean Difference (Final Values)|0.92||||0.529|2-Sided|95.0|-1.95|3.79|||ANCOVA||||
1680699|NCT01237587|3091816|Superiority||Mean Difference (Final Values)|1.03||||0.431|2-Sided|95.0|-1.54|3.59|||ANCOVA||||
1680700|NCT01237587|3091817|Superiority||Mean Difference (Final Values)|-0.01||||0.927|2-Sided|95.0|-0.23|0.21|||ANCOVA||||
1680701|NCT01237587|3091818|Superiority||Mean Difference (Final Values)|-0.22||||0.146|2-Sided|95.0|-0.52|0.08|||ANCOVA||||
1680702|NCT01237587|3091819|Superiority||Mean Difference (Final Values)|-1.79||||0.647|2-Sided|95.0|-9.53|5.94|||ANCOVA|||Pain Score Right Now|
1680703|NCT01237587|3091819|Superiority||Mean Difference (Final Values)|-5.9||||0.169|2-Sided|95.0|-14.32|2.53|||ANCOVA|||Worst Pain Score|
1680704|NCT01237587|3091819|Superiority||Mean Difference (Final Values)|1.62||||0.669|2-Sided|95.0|-9.1|5.86|||ANCOVA|||Average Pain Score|
1680705|NCT01237587|3091820|Superiority|||||||0.038|||||||Fisher Exact||||
1680706|NCT01237587|3091821|Superiority|||||||0.051|||||||Fisher Exact||||
1680707|NCT01237587|3091823|Superiority||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.424||0.16|2-Sided|95.0|-1.44|0.24|||Mixed Models Analysis|||School Work|
1680708|NCT01237587|3091823|Superiority||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.338||0.39|2-Sided|95.0|-0.96|0.38|||Mixed Models Analysis|||Enjoyment of Life|
1680709|NCT01237587|3091823|Superiority||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.454||0.443|2-Sided|95.0|-1.25|0.55|||Mixed Models Analysis|||Sleep|
1680710|NCT01237587|3091823|Superiority||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.312||0.011|2-Sided|95.0|-1.42|-0.19|||Mixed Models Analysis|||Relations With Other|
1680711|NCT01237587|3091823|Superiority||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.371||0.448|2-Sided|95.0|-1.01|0.45|||Mixed Models Analysis|||Normal Work|
1680712|NCT01237587|3091823|Superiority||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.352||0.56|2-Sided|95.0|-0.9|0.49|||Mixed Models Analysis|||Walking ability|
1680713|NCT01237587|3091823|Superiority||Mean Difference (Final Values)|-0.54|Standard Error of the Mean|0.356||0.128|2-Sided|95.0|-1.25|0.16|||Mixed Models Analysis|||Mood|
1680714|NCT01237587|3091823|Superiority||Mean Difference (Final Values)|-0.97|Standard Error of the Mean|0.344||0.005|2-Sided|95.0|-1.65|-0.3|||Mixed Models Analysis|||General Activity|
1680715|NCT01237587|3091823|Superiority||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.365||0.165|2-Sided|95.0|-1.23|0.21|||Mixed Models Analysis|||Pain Right Now|
1680716|NCT01237587|3091823|Superiority||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.319||0.059|2-Sided|95.0|-1.24|0.02|||Mixed Models Analysis|||Least Pain|
1680717|NCT01237587|3091823|Superiority||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|0.36||0.059|2-Sided|95.0|-1.4|0.03|||Mixed Models Analysis|||Worst Pain|
1680718|NCT01237587|3091824|Superiority||LS mean change difference|-0.65|Standard Error of the Mean|0.33||0.052|2-Sided|95.0|-1.3|0.0|||Repeated Measures||||
1680719|NCT01237327|3091837|Superiority or Other||Hazard Ratio (HR)|0.7799||||0.3348|2-Sided|95.0|0.47|1.294|||Log Rank|||Overall survival compared using the hazard ratio; hazard ratio <1.0 is in favor of exemestane.|
1680720|NCT01237054|3091856|Superiority|||||||0.011|||||||Wilcoxon rank sum test||||
1680721|NCT01237054|3091857|Superiority|||||||0.08|||||||Wilcoxon rank sum test||||
1680722|NCT01237054|3091858|Other|Other, trend test.||||||0.33||||||The reported p-value is representative of the difference in levels of Ktrans between MGUS and SMM+MM.|Jonckheere-Terpstra test for trend||||
1680723|NCT01237054|3091858|Other|Other, trend test.||||||0.15||||||The reported p-value is representative of the difference in levels of Kep between MGUS and SMM+MM.|Jonckheere-Terpstra test for trend||||
1680724|NCT01237054|3091859|Other|Other, trend test.||||||0.008|||||||Jonckheere-Terpstra test for trend||||
1680725|NCT01237054|3091860|Superiority|||||||0.02||||||The reported p-value is representative of the difference in levels of VEGF-A in both groups.|Wilcoxon rank sum test||||
1680726|NCT01237054|3091860|Superiority|||||||0.0098||||||The reported p-value is representative of the difference in levels of HGF in both groups.|Wilcoxon rank sum test||||
1680727|NCT01237054|3091860|Superiority|||||||0.055||||||The reported p-value is representative of the difference in levels of Follistatin in both groups.|Wilcoxon rank sum test||||
1680728|NCT01237054|3091860|Superiority|||||||0.055||||||The reported p-value is representative of the difference in levels of G-CSF in both groups.|Wilcoxon rank sum test||||
1680729|NCT01237054|3091860|Superiority|||||||0.024||||||The reported p-value is representative of the difference in levels of Ang2 in both groups.|Wilcoxon rank sum test||||
1680730|NCT01237041|3091863|Superiority|||||||0.113|||||||ANOVA|||ANOVA, 2 groups, essentially an unpaired t-test.|
1680731|NCT01237041|3091864|Superiority|||||||0.543|||||||ANOVA|||ANOVA, 3 dose-finding groups|
1680732|NCT01237041|3091865|Superiority|ANOVA of the 3 dose-finding groups. Data transformed using log(10) for analysis||||||0.043||||||A priori threshold for significance p<0.05|ANOVA|||Analysis of FFA Area Under Curve in dose-finding studies. Data were log-transformed before analysis.|
1680733|NCT01237041|3091866|Superiority|Univariate ANOVA||||||0.016||||||A priori threshold p<0.05|ANOVA|Comparison of 3 dose-finding groups. Post-hoc comparisons between groups also done.||ANOVA to compare AUC of GH among groups|
1680734|NCT01236768|3091870|Equivalence|Comparative analysis of AG200-15 and Levora for breakthrough bleeding and/or spotting.||||||0.089|||||||Chi-squared|||Comparative evaluation of AG200-15 and Levora|
1680735|NCT01236365|3091883|Other|||||||0.09|||||||t-test, 2 sided||||
1680736|NCT01236365|3091886|Superiority or Other|||||||0.913||||||Change in hsCRP (6months minus 0months) between Atorvastatin and Placebo|Wilcoxon (Mann-Whitney)||||
1680737|NCT01236365|3091887|Superiority or Other||||||<|0.0001||||||Change in LDL-C between Atorvastatin and Placebo|Mixed Models Analysis||||
1680738|NCT01236521|3091911|Superiority||Median Difference (Net)|0.39|Standard Deviation|0.15||0.074|2-Sided||||||Mixed Models Analysis||||
1680739|NCT01236521|3091912|Superiority||Mean Difference (Net)|0.44|Standard Deviation|0.11||0.0067|2-Sided||||||Mixed Models Analysis||||
1680740|NCT01236521|3091913|Superiority||Mean Difference (Net)|0.39|Standard Deviation|0.13||0.0385|2-Sided||||||Mixed Models Analysis||||
1680741|NCT01236196|3091947|Superiority or Other|||||||0.09|||||||Mixed Models Analysis||||
1680742|NCT01236196|3091948|Superiority or Other|||||||0.01|||||||Mixed Models Analysis||||
1680743|NCT01236196|3091949|Superiority or Other|||||||0.8|||||||Mixed Models Analysis||||
1680744|NCT01236196|3091950|Superiority or Other|||||||0.11|||||||Mixed Models Analysis||||
1680745|NCT01236053|3091960|Superiority or Other||Odds Ratio (OR)|0.84||||0.7429|2-Sided|95.0|0.29|2.4|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680746|NCT01236053|3091960|Superiority or Other||Odds Ratio (OR)|1.08||||0.8781|2-Sided|95.0|0.38|3.07|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680747|NCT01236053|3091960|Superiority or Other||Odds Ratio (OR)|0.79||||0.7543|2-Sided|95.0|0.18|3.44|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680748|NCT01236053|3091960|Superiority or Other||Odds Ratio (OR)|1.05||||0.9514|2-Sided|95.0|0.24|4.5|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680749|NCT01236053|3091960|Superiority or Other||Odds Ratio (OR)|0.96||||0.9256|2-Sided|95.0|0.4|2.32|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680750|NCT01236053|3091960|Superiority or Other||Odds Ratio (OR)|1.23||||0.6402|2-Sided|95.0|0.51|2.95|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680751|NCT01236053|3091960|Superiority or Other||Odds Ratio (OR)|1.06||||0.9277|2-Sided|95.0|0.31|3.67|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680752|NCT01236053|3091960|Superiority or Other||Odds Ratio (OR)|1.45||||0.5512|2-Sided|95.0|0.43|4.95|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680753|NCT01236053|3091960|Superiority or Other||Odds Ratio (OR)|1.43||||0.4622|2-Sided|95.0|0.55|3.73|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680754|NCT01236053|3091960|Superiority or Other||Odds Ratio (OR)|1.43||||0.4583|2-Sided|95.0|0.55|3.7|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680755|NCT01236053|3091960|Superiority or Other||Odds Ratio (OR)|2.71||||0.081|2-Sided|95.0|0.88|8.28|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680756|NCT01236053|3091960|Superiority or Other||Odds Ratio (OR)|2.64||||0.0843|2-Sided|95.0|0.88|7.96|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680757|NCT01236053|3091962|Superiority or Other||Odds Ratio (OR)|1.37||||0.4932|2-Sided|95.0|0.56|3.37|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680758|NCT01236053|3091962|Superiority or Other||Odds Ratio (OR)|1.78||||0.2031|2-Sided|95.0|0.73|4.3|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680759|NCT01236053|3091962|Superiority or Other||Odds Ratio (OR)|1.29||||0.6899|2-Sided|95.0|0.37|4.58|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680760|NCT01236053|3091962|Superiority or Other||Odds Ratio (OR)|1.8||||0.3591|2-Sided|95.0|0.51|6.28|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680761|NCT01236053|3091962|Superiority or Other||Adjusted Odds Ratio|0.63||||0.3821|2-Sided|95.0|0.22|1.78|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680762|NCT01236053|3091962|Superiority or Other||Odds Ratio (OR)|0.77||||0.6132|2-Sided|95.0|0.27|2.15|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680763|NCT01236053|3091962|Superiority or Other||Odds Ratio (OR)|1.1||||0.8743|2-Sided|95.0|0.32|3.75|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680764|NCT01236053|3091962|Superiority or Other||Odds Ratio (OR)|1.34||||0.6332|2-Sided|95.0|0.4|4.48|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680765|NCT01236053|3091962|Superiority or Other||Odds Ratio (OR)|1.34||||0.5535|2-Sided|95.0|0.51|3.47|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680766|NCT01236053|3091962|Superiority or Other||Odds Ratio (OR)|1.45||||0.4388|2-Sided|95.0|0.56|3.75|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680767|NCT01236053|3091962|Superiority or Other||Odds Ratio (OR)|1.73||||0.3951|2-Sided|95.0|0.49|6.15|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680768|NCT01236053|3091962|Superiority or Other||Odds Ratio (OR)|1.9||||0.3123|2-Sided|95.0|0.55|6.59|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680769|NCT01236053|3091963|Superiority or Other||Odds Ratio (OR)|1.32||||0.5428|2-Sided|95.0|0.54|3.24|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680770|NCT01236053|3091963|Superiority or Other||Odds Ratio (OR)|1.71||||0.235|2-Sided|95.0|0.71|4.13|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680771|NCT01236053|3091963|Superiority or Other||Odds Ratio (OR)|1.23||||0.7478|2-Sided|95.0|0.35|4.29|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680772|NCT01236053|3091963|Superiority or Other||Odds Ratio (OR)|1.6||||0.4556|2-Sided|95.0|0.46|5.53|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680773|NCT01236053|3091963|Superiority or Other||Odds Ratio (OR)|0.74||||0.6178|2-Sided|95.0|0.22|2.46|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680774|NCT01236053|3091963|Superiority or Other||Odds Ratio (OR)|0.91||||0.8833|2-Sided|95.0|0.28|3.02|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680775|NCT01236053|3091963|Superiority or Other||Odds Ratio (OR)|1.06||||0.9345|2-Sided|95.0|0.24|4.73|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680776|NCT01236053|3091963|Superiority or Other||Odds Ratio (OR)|1.31||||0.7164|2-Sided|95.0|0.3|5.75|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680777|NCT01236053|3091963|Superiority or Other||Odds Ratio (OR)|1.03||||0.9502|2-Sided|95.0|0.43|2.46|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680778|NCT01236053|3091963|Superiority or Other||Odds Ratio (OR)|1.14||||0.7599|2-Sided|95.0|0.48|2.71|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680779|NCT01236053|3091963|Superiority or Other||Odds Ratio (OR)|1.64||||0.3764|2-Sided|95.0|0.55|4.93|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680780|NCT01236053|3091963|Superiority or Other||Odds Ratio (OR)|1.91||||0.2395|2-Sided|95.0|0.65|5.6|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680781|NCT01236053|3091964|Superiority or Other||Odds Ratio (OR)|1.04||||0.9034|2-Sided|95.0|0.59|1.82|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680782|NCT01236053|3091964|Superiority or Other||Odds Ratio (OR)|1.24||||0.442|2-Sided|95.0|0.71|2.16|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”.||
1680783|NCT01236053|3091964|Superiority or Other||Odds Ratio (OR)|1.33||||0.4405|2-Sided|95.0|0.64|2.75|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, hypertension, diuretic use.||
1680784|NCT01236053|3091964|Superiority or Other||Odds Ratio (OR)|1.64||||0.1757|2-Sided|95.0|0.8|3.34|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”.||
1680810|NCT01236053|3091968|Superiority or Other||Odds Ratio (OR)|1.73||||0.0712|2-Sided|95.0|0.95|3.13|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680785|NCT01236053|3091965|Superiority or Other||Odds Ratio (OR)|1.34||||0.3809|2-Sided|95.0|0.69|2.61|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680786|NCT01236053|3091965|Superiority or Other||Odds Ratio (OR)|1.66||||0.1227|2-Sided|95.0|0.87|3.16|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680787|NCT01236053|3091965|Superiority or Other||Odds Ratio (OR)|1.0||||0.9922|2-Sided|95.0|0.37|2.69|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680788|NCT01236053|3091965|Superiority or Other||Odds Ratio (OR)|1.21||||0.7032|2-Sided|95.0|0.45|3.21|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680789|NCT01236053|3091965|Superiority or Other||Odds Ratio (OR)|1.52||||0.2944|2-Sided|95.0|0.7|3.31|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680790|NCT01236053|3091965|Superiority or Other||Odds Ratio (OR)|1.8||||0.1257|2-Sided|95.0|0.85|3.83|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680791|NCT01236053|3091965|Superiority or Other||Odds Ratio (OR)|2.11||||0.1285|2-Sided|95.0|0.81|5.51|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680792|NCT01236053|3091965|Superiority or Other||Odds Ratio (OR)|2.75||||0.0309|2-Sided|95.0|1.1|6.88|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680793|NCT01236053|3091965|Superiority or Other||Odds Ratio (OR)|2.05||||0.0193|2-Sided|95.0|1.12|3.72|||Wilcoxon (Mann-Whitney)||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680794|NCT01236053|3091965|Superiority or Other||Odds Ratio (OR)|2.33||||0.0046|2-Sided|95.0|1.3|4.2|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680795|NCT01236053|3091965|Superiority or Other||Odds Ratio (OR)|2.16||||0.052|2-Sided|95.0|0.99|4.7|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680796|NCT01236053|3091965|Superiority or Other||Odds Ratio (OR)|2.38||||0.0248|2-Sided|95.0|1.12|5.09|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680797|NCT01236053|3091967|Superiority or Other||Odds Ratio (OR)|1.51||||0.1815|2-Sided|95.0|0.82|2.77|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680798|NCT01236053|3091967|Superiority or Other||Odds Ratio (OR)|1.97||||0.0224|2-Sided|95.0|1.1|3.53|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680799|NCT01236053|3091967|Superiority or Other||Odds Ratio (OR)|1.32||||0.5391|2-Sided|95.0|0.54|3.21|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680800|NCT01236053|3091967|Superiority or Other||Odds Ratio (OR)|1.75||||0.198|2-Sided|95.0|0.75|4.1|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680801|NCT01236053|3091967|Superiority or Other||Odds Ratio (OR)|1.1||||0.837|2-Sided|95.0|0.43|2.81|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680802|NCT01236053|3091967|Superiority or Other||Unadjusted Odds Ratio|1.15||||0.7733|2-Sided|95.0|0.45|2.9|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680803|NCT01236053|3091967|Superiority or Other||Odds Ratio (OR)|0.61||||0.5103|2-Sided|95.0|0.14|2.62|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680804|NCT01236053|3091967|Superiority or Other||Odds Ratio (OR)|0.7||||0.6281|2-Sided|95.0|0.17|2.96|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680805|NCT01236053|3091967|Superiority or Other||Odds Ratio (OR)|2.18||||0.0115|2-Sided|95.0|1.19|4.0|||Wilcoxon (Mann-Whitney)||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680806|NCT01236053|3091967|Superiority or Other||Odds Ratio (OR)|2.51||||0.0024|2-Sided|95.0|1.39|4.55|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680807|NCT01236053|3091967|Superiority or Other||Odds Ratio (OR)|3.25||||0.0019|2-Sided|95.0|1.55|6.83|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680808|NCT01236053|3091967|Superiority or Other||Odds Ratio (OR)|3.61||||0.0005|2-Sided|95.0|1.75|7.46|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680809|NCT01236053|3091968|Superiority or Other||Odds Ratio (OR)|1.41||||0.2674|2-Sided|95.0|0.77|2.6|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1681177|NCT01235689|3092129|Superiority|||||||0.728|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (< 70 kg, ≥ 70 kg).|||
1680811|NCT01236053|3091968|Superiority or Other||Odds Ratio (OR)|1.11||||0.8266|2-Sided|95.0|0.43|2.87|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680812|NCT01236053|3091968|Superiority or Other||Odds Ratio (OR)|1.51||||0.3731|2-Sided|95.0|0.61|3.74|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680813|NCT01236053|3091968|Superiority or Other||Odds Ratio (OR)|1.07||||0.906|2-Sided|95.0|0.35|3.22|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680814|NCT01236053|3091968|Superiority or Other||Odds Ratio (OR)|1.29||||0.6316|2-Sided|95.0|0.45|3.68|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680815|NCT01236053|3091968|Superiority or Other||Odds Ratio (OR)|0.72||||0.6624|2-Sided|95.0|0.17|3.12|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680816|NCT01236053|3091968|Superiority or Other||Odds Ratio (OR)|0.84||||0.8165|2-Sided|95.0|0.2|3.61|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680817|NCT01236053|3091968|Superiority or Other||Odds Ratio (OR)|2.16||||0.008|2-Sided|95.0|1.22|3.8|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680818|NCT01236053|3091968|Superiority or Other||Odds Ratio (OR)|2.49||||0.0013|2-Sided|95.0|1.43|4.34|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680819|NCT01236053|3091968|Superiority or Other||Odds Ratio (OR)|3.01||||0.002|2-Sided|95.0|1.5|6.05|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680820|NCT01236053|3091968|Superiority or Other||Odds Ratio (OR)|3.29||||0.0006|2-Sided|95.0|1.66|6.53|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680821|NCT01236053|3091969|Superiority or Other||Odds Ratio (OR)|1.63||||0.0138|2-Sided|95.0|1.11|2.41|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680822|NCT01236053|3091969|Superiority or Other||Odds Ratio (OR)|1.93||||0.0006|2-Sided|95.0|1.33|2.82|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”.||
1680823|NCT01236053|3091969|Superiority or Other||Odds Ratio (OR)|1.68||||0.0494|2-Sided|95.0|1.0|2.82|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, chronic pancreatitis.||
1680824|NCT01236053|3091969|Superiority or Other||Odds Ratio (OR)|2.01||||0.0066|2-Sided|95.0|1.21|3.32|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”.||
1680825|NCT01236053|3091970|Superiority or Other||Odds Ratio (OR)|4.1||||0.3799|2-Sided|95.0|0.18|95.82|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680826|NCT01236053|3091970|Superiority or Other||Odds Ratio (OR)|10.0||||0.1035|2-Sided|95.0|0.63|159.9|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680827|NCT01236053|3091972|Superiority or Other||Odds Ratio (OR)|4.1||||0.3799|2-Sided|95.0|0.18|95.82|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680828|NCT01236053|3091972|Superiority or Other||Odds Ratio (OR)|10.0||||0.1035|2-Sided|95.0|0.63|159.9|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680829|NCT01236053|3091973|Superiority or Other||Odds Ratio (OR)|4.1||||0.3799|2-Sided|95.0|0.18|95.82|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680830|NCT01236053|3091973|Superiority or Other||Unadjusted Odds Ratio|10.0||||0.1035|2-Sided|95.0|0.63|159.9|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680831|NCT01236053|3091974|Superiority or Other||Odds Ratio (OR)|10.79||||0.0743|2-Sided|95.0|0.79|147.0|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680832|NCT01236053|3091974|Superiority or Other||Odds Ratio (OR)|20.0||||0.0144|2-Sided|95.0|1.81|220.5|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”.||
1680833|NCT01236053|3091975|Superiority or Other||Odds Ratio (OR)|0.78||||0.4944|2-Sided|95.0|0.39|1.58|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680834|NCT01236053|3091975|Superiority or Other||Odds Ratio (OR)|0.99||||0.98|2-Sided|95.0|0.5|1.98|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680835|NCT01236053|3091975|Superiority or Other||Odds Ratio (OR)|0.9||||0.8189|2-Sided|95.0|0.35|2.3|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680836|NCT01236053|3091975|Superiority or Other||Odds Ratio (OR)|1.15||||0.7693|2-Sided|95.0|0.45|2.92|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680837|NCT01236053|3091975|Superiority or Other||Odds Ratio (OR)|0.79||||0.4831|2-Sided|95.0|0.41|1.53|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680838|NCT01236053|3091975|Superiority or Other||Odds Ratio (OR)|0.89||||0.73|2-Sided|95.0|0.46|1.72|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680839|NCT01236053|3091975|Superiority or Other||Adjusted Odds Ratio|0.6||||0.3275|2-Sided|95.0|0.21|1.68|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680840|NCT01236053|3091975|Superiority or Other||Odds Ratio (OR)|0.73||||0.5529|2-Sided|95.0|0.26|2.04|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680841|NCT01236053|3091975|Superiority or Other||Odds Ratio (OR)|1.06||||0.8521|2-Sided|95.0|0.6|1.85|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680842|NCT01236053|3091975|Superiority or Other||Odds Ratio (OR)|1.18||||0.5592|2-Sided|95.0|0.68|2.07|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680843|NCT01236053|3091975|Superiority or Other||Odds Ratio (OR)|1.05||||0.9104|2-Sided|95.0|0.45|2.46|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680844|NCT01236053|3091975|Superiority or Other||Odds Ratio (OR)|1.11||||0.8111|2-Sided|95.0|0.48|2.59|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680845|NCT01236053|3091977|Superiority or Other||Odds Ratio (OR)|0.86||||0.6577|2-Sided|95.0|0.44|1.67|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680846|NCT01236053|3091977|Superiority or Other||Odds Ratio (OR)|1.1||||0.78|2-Sided|95.0|0.57|2.12|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680847|NCT01236053|3091977|Superiority or Other||Odds Ratio (OR)|1.06||||0.8994|2-Sided|95.0|0.44|2.52|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680848|NCT01236053|3091977|Superiority or Other||Odds Ratio (OR)|1.37||||0.4779|2-Sided|95.0|0.58|3.23|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680849|NCT01236053|3091977|Superiority or Other||Odds Ratio (OR)|0.94||||0.8591|2-Sided|95.0|0.5|1.77|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680850|NCT01236053|3091977|Superiority or Other||Odds Ratio (OR)|1.04||||0.8922|2-Sided|95.0|0.56|1.95|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680851|NCT01236053|3091977|Superiority or Other||Odds Ratio (OR)|0.67||||0.4353|2-Sided|95.0|0.24|1.85|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680852|NCT01236053|3091977|Superiority or Other||Odds Ratio (OR)|0.74||||0.567|2-Sided|95.0|0.27|2.06|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680853|NCT01236053|3091977|Superiority or Other||Odds Ratio (OR)|0.85||||0.6|2-Sided|95.0|0.46|1.56|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680854|NCT01236053|3091977|Superiority or Other||Odds Ratio (OR)|0.96||||0.9003|2-Sided|95.0|0.53|1.76|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680855|NCT01236053|3091977|Superiority or Other||Odds Ratio (OR)|0.8||||0.6482|2-Sided|95.0|0.32|2.05|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680856|NCT01236053|3091977|Superiority or Other||Odds Ratio (OR)|0.92||||0.8655|2-Sided|95.0|0.37|2.33|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680857|NCT01236053|3091978|Superiority or Other||Odds Ratio (OR)|0.8||||0.5125|2-Sided|95.0|0.41|1.56|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680858|NCT01236053|3091978|Superiority or Other||Odds Ratio (OR)|1.03||||0.9308|2-Sided|95.0|0.53|1.99|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680859|NCT01236053|3091978|Superiority or Other||Odds Ratio (OR)|1.06||||0.8998|2-Sided|95.0|0.44|2.52|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680860|NCT01236053|3091978|Superiority or Other||Odds Ratio (OR)|1.37||||0.4782|2-Sided|95.0|0.58|3.23|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680861|NCT01236053|3091978|Superiority or Other||Odds Ratio (OR)|1.21||||0.582|2-Sided|95.0|0.62|2.36|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680862|NCT01236053|3091978|Superiority or Other||Odds Ratio (OR)|1.35||||0.3762|2-Sided|95.0|0.69|2.63|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680863|NCT01236053|3091978|Superiority or Other||Odds Ratio (OR)|0.71||||0.5731|2-Sided|95.0|0.22|2.33|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680864|NCT01236053|3091978|Superiority or Other||Odds Ratio (OR)|0.81||||0.7329|2-Sided|95.0|0.25|2.66|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680865|NCT01236053|3091978|Superiority or Other||Odds Ratio (OR)|0.78||||0.4002|2-Sided|95.0|0.44|1.39|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680866|NCT01236053|3091978|Superiority or Other||Odds Ratio (OR)|0.86||||0.6164|2-Sided|95.0|0.49|1.53|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680867|NCT01236053|3091978|Superiority or Other||Odds Ratio (OR)|0.75||||0.5024|2-Sided|95.0|0.32|1.75|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680868|NCT01236053|3091978|Superiority or Other||Odds Ratio (OR)|0.84||||0.6888|2-Sided|95.0|0.36|1.95|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680869|NCT01236053|3091979|Superiority or Other||Odds Ratio (OR)|0.88||||0.5078|2-Sided|95.0|0.61|1.28|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680870|NCT01236053|3091979|Superiority or Other||Odds Ratio (OR)|1.03||||0.8856|2-Sided|95.0|0.71|1.48|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”.||
1680871|NCT01236053|3091979|Superiority or Other||Odds Ratio (OR)|0.84||||0.5179|2-Sided|95.0|0.49|1.44|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680872|NCT01236053|3091979|Superiority or Other||Odds Ratio (OR)|0.99||||0.9614|2-Sided|95.0|0.58|1.69|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”.||
1680873|NCT01236053|3091980|Superiority or Other||Odds Ratio (OR)|20.4||||0.1118|2-Sided|95.0|0.5|839.0|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis.||
1680874|NCT01236053|3091980|Superiority or Other||Odds Ratio (OR)|6.32||||0.2038|2-Sided|95.0|0.37|108.8|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680875|NCT01236053|3091980|Superiority or Other||Odds Ratio (OR)|4.63||||0.2866|2-Sided|95.0|0.28|77.51|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis.||
1680876|NCT01236053|3091980|Superiority or Other||Odds Ratio (OR)|6.32||||0.2038|2-Sided|95.0|0.37|108.8|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680877|NCT01236053|3091982|Superiority or Other||Odds Ratio (OR)|20.4||||0.1118|2-Sided|95.0|0.5|839.0|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis.||
1680878|NCT01236053|3091982|Superiority or Other||Odds Ratio (OR)|6.32||||0.2038|2-Sided|95.0|0.37|108.8|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680879|NCT01236053|3091982|Superiority or Other||Odds Ratio (OR)|4.63||||0.2866|2-Sided|95.0|0.28|77.51|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis.||
1680880|NCT01236053|3091982|Superiority or Other||Odds Ratio (OR)|6.32||||0.2038|2-Sided|95.0|0.37|108.8|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680881|NCT01236053|3091983|Superiority or Other||Odds Ratio (OR)|20.4||||0.1118|2-Sided|95.0|0.5|839.0|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis.||
1680882|NCT01236053|3091983|Superiority or Other||Odds Ratio (OR)|6.32||||0.2038|2-Sided|95.0|0.37|108.8|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680883|NCT01236053|3091983|Superiority or Other||Odds Ratio (OR)|4.63||||0.2866|2-Sided|95.0|0.28|77.51|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis.||
1680884|NCT01236053|3091983|Superiority or Other||Odds Ratio (OR)|6.32||||0.2038|2-Sided|95.0|0.37|108.8|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680885|NCT01236053|3091984|Superiority or Other||Odds Ratio (OR)|1.75||||0.6303|2-Sided|95.0|0.18|17.07|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis.||
1680886|NCT01236053|3091984|Superiority or Other||Odds Ratio (OR)|1.42||||0.7509|2-Sided|95.0|0.16|12.52|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”.||
1680887|NCT01236053|3091984|Superiority or Other||Odds Ratio (OR)|2.9||||0.3999|2-Sided|95.0|0.24|34.69|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital), phimosis/balanitis.||
1680888|NCT01236053|3091984|Superiority or Other||Odds Ratio (OR)|3.58||||0.3082|2-Sided|95.0|0.31|41.71|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”.||
1680912|NCT01236053|3091986|Superiority or Other||Odds Ratio (OR)|1.51||||0.0892|2-Sided|95.0|0.94|2.42|||Conditional Logistic Regression||Comparison: “> 1 year (with 2 year lag)” and “Never (with 2 year lag)”.||
1680889|NCT01236053|3091985|Superiority or Other||Odds Ratio (OR)|1.25||||0.0939|2-Sided|95.0|0.96|1.63|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680890|NCT01236053|3091985|Superiority or Other||Odds Ratio (OR)|1.29||||0.0564|2-Sided|95.0|0.99|1.68|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680891|NCT01236053|3091985|Superiority or Other||Odds Ratio (OR)|1.34||||0.1091|2-Sided|95.0|0.94|1.92|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680892|NCT01236053|3091985|Superiority or Other||Odds Ratio (OR)|1.36||||0.0921|2-Sided|95.0|0.95|1.94|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680893|NCT01236053|3091985|Superiority or Other||Odds Ratio (OR)|0.96||||0.7809|2-Sided|95.0|0.7|1.31|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680894|NCT01236053|3091985|Superiority or Other||Odds Ratio (OR)|0.97||||0.8352|2-Sided|95.0|0.71|1.32|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680895|NCT01236053|3091985|Superiority or Other||Odds Ratio (OR)|1.23||||0.294|2-Sided|95.0|0.84|1.8|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680896|NCT01236053|3091985|Superiority or Other||Odds Ratio (OR)|1.27||||0.214|2-Sided|95.0|0.87|1.87|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680897|NCT01236053|3091985|Superiority or Other||Odds Ratio (OR)|1.25||||0.0939|2-Sided|95.0|0.96|1.62|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680898|NCT01236053|3091985|Superiority or Other||Odds Ratio (OR)|1.29||||0.054|2-Sided|95.0|1.0|1.67|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680899|NCT01236053|3091985|Superiority or Other||Odds Ratio (OR)|1.11||||0.5908|2-Sided|95.0|0.76|1.62|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680900|NCT01236053|3091985|Superiority or Other||Odds Ratio (OR)|1.17||||0.4233|2-Sided|95.0|0.8|1.7|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680901|NCT01236053|3091986|Superiority or Other||Odds Ratio (OR)|1.81||||0.0873|2-Sided|95.0|0.92|3.58|||Conditional Logistic Regression||Comparison: “> 3 years (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680902|NCT01236053|3091986|Superiority or Other||Odds Ratio (OR)|1.84||||0.0787|2-Sided|95.0|0.93|3.64|||Conditional Logistic Regression||Comparison: “> 3 years (without 2 year lag)” and “Never (without 2 year lag)”.||
1680903|NCT01236053|3091986|Superiority or Other||Odds Ratio (OR)|0.76||||0.7088|2-Sided|95.0|0.18|3.21|||Conditional Logistic Regression||Comparison: “> 3 years (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680904|NCT01236053|3091986|Superiority or Other||Odds Ratio (OR)|0.8||||0.7573|2-Sided|95.0|0.19|3.36|||Conditional Logistic Regression||Comparison: “> 3 years (with 2 year lag)” and “Never (with 2 year lag)”.||
1680905|NCT01236053|3091986|Superiority or Other||Odds Ratio (OR)|1.72||||0.0162|2-Sided|95.0|1.1|2.67|||Conditional Logistic Regression||Comparison: “> 2 years (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680906|NCT01236053|3091986|Superiority or Other||Odds Ratio (OR)|1.75||||0.0122|2-Sided|95.0|1.13|2.72|||Conditional Logistic Regression||Comparison: “> 2 years (without 2 year lag)” and “Never (without 2 year lag)”.||
1680907|NCT01236053|3091986|Superiority or Other||Odds Ratio (OR)|1.62||||0.1859|2-Sided|95.0|0.79|3.29|||Conditional Logistic Regression||Comparison: “> 2 years (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680908|NCT01236053|3091986|Superiority or Other||Odds Ratio (OR)|1.69||||0.1458|2-Sided|95.0|0.83|3.43|||Conditional Logistic Regression||Comparison: “> 2 years (with 2 year lag)” and “Never (with 2 year lag)”.||
1680909|NCT01236053|3091986|Superiority or Other||Odds Ratio (OR)|1.46||||0.0186|2-Sided|95.0|1.07|2.0|||Conditional Logistic Regression||Comparison: “> 1 year (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680910|NCT01236053|3091986|Superiority or Other||Odds Ratio (OR)|1.51||||0.0101|2-Sided|95.0|1.1|2.06|||Conditional Logistic Regression||Comparison: “> 1 year (without 2 year lag)” and “Never (without 2 year lag)”.||
1680911|NCT01236053|3091986|Superiority or Other||Odds Ratio (OR)|1.48||||0.1043|2-Sided|95.0|0.92|2.39|||Conditional Logistic Regression||Comparison: “> 1 year (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680913|NCT01236053|3091987|Superiority or Other||Odds Ratio (OR)|1.3||||0.0508|2-Sided|95.0|1.0|1.7|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680914|NCT01236053|3091987|Superiority or Other||Odds Ratio (OR)|1.34||||0.0312|2-Sided|95.0|1.03|1.74|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680915|NCT01236053|3091987|Superiority or Other||Odds Ratio (OR)|1.42||||0.0542|2-Sided|95.0|0.99|2.04|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680916|NCT01236053|3091987|Superiority or Other||Odds Ratio (OR)|1.44||||0.0459|2-Sided|95.0|1.01|2.06|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680917|NCT01236053|3091987|Superiority or Other||Odds Ratio (OR)|1.03||||0.852|2-Sided|95.0|0.77|1.37|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680918|NCT01236053|3091987|Superiority or Other||Odds Ratio (OR)|1.05||||0.7559|2-Sided|95.0|0.78|1.4|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680919|NCT01236053|3091987|Superiority or Other||Odds Ratio (OR)|1.19||||0.365|2-Sided|95.0|0.82|1.72|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680920|NCT01236053|3091987|Superiority or Other||Odds Ratio (OR)|1.22||||0.2849|2-Sided|95.0|0.84|1.77|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680921|NCT01236053|3091987|Superiority or Other||Odds Ratio (OR)|1.16||||0.3005|2-Sided|95.0|0.88|1.52|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680922|NCT01236053|3091987|Superiority or Other||Odds Ratio (OR)|1.19||||0.2055|2-Sided|95.0|0.91|1.57|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680923|NCT01236053|3091987|Superiority or Other||Odds Ratio (OR)|1.08||||0.7129|2-Sided|95.0|0.73|1.59|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680924|NCT01236053|3091987|Superiority or Other||Odds Ratio (OR)|1.14||||0.5043|2-Sided|95.0|0.77|1.68|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680925|NCT01236053|3091988|Superiority or Other||Odds Ratio (OR)|1.35||||0.0241|2-Sided|95.0|1.04|1.75|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680926|NCT01236053|3091988|Superiority or Other||Odds Ratio (OR)|1.39||||0.013|2-Sided|95.0|1.07|1.8|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680927|NCT01236053|3091988|Superiority or Other||Odds Ratio (OR)|1.36||||0.0932|2-Sided|95.0|0.95|1.96|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680928|NCT01236053|3091988|Superiority or Other||Odds Ratio (OR)|1.38||||0.0827|2-Sided|95.0|0.96|1.98|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680929|NCT01236053|3091988|Superiority or Other||Odds Ratio (OR)|0.84||||0.3349|2-Sided|95.0|0.58|1.2|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680930|NCT01236053|3091988|Superiority or Other||Odds Ratio (OR)|0.86||||0.3987|2-Sided|95.0|0.59|1.23|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680931|NCT01236053|3091988|Superiority or Other||Odds Ratio (OR)|1.17||||0.4654|2-Sided|95.0|0.76|1.81|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680932|NCT01236053|3091988|Superiority or Other||Odds Ratio (OR)|1.23||||0.3502|2-Sided|95.0|0.8|1.89|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680933|NCT01236053|3091988|Superiority or Other||Odds Ratio (OR)|1.21||||0.1226|2-Sided|95.0|0.95|1.55|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680934|NCT01236053|3091988|Superiority or Other||Odds Ratio (OR)|1.24||||0.0806|2-Sided|95.0|0.97|1.58|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680935|NCT01236053|3091988|Superiority or Other||Odds Ratio (OR)|1.15||||0.4301|2-Sided|95.0|0.82|1.61|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680936|NCT01236053|3091988|Superiority or Other||Odds Ratio (OR)|1.2||||0.2893|2-Sided|95.0|0.86|1.69|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680937|NCT01236053|3091989|Superiority or Other||Odds Ratio (OR)|1.16||||0.0699|2-Sided|95.0|0.99|1.36|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680938|NCT01236053|3091989|Superiority or Other||Odds Ratio (OR)|1.19||||0.0326|2-Sided|95.0|1.01|1.4|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”.||
1680939|NCT01236053|3091989|Superiority or Other||Odds Ratio (OR)|1.22||||0.0682|2-Sided|95.0|0.99|1.52|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, hysterectomy, current estrogen, prior estrogen, benign breast disease.||
1680940|NCT01236053|3091989|Superiority or Other||Odds Ratio (OR)|1.27||||0.0323|2-Sided|95.0|1.02|1.57|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”.||
1680941|NCT01236053|3091990|Superiority or Other||Odds Ratio (OR)|0.95||||0.9613|2-Sided|95.0|0.12|7.78|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680942|NCT01236053|3091990|Superiority or Other||Odds Ratio (OR)|1.12||||0.9141|2-Sided|95.0|0.14|9.03|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680943|NCT01236053|3091992|Superiority or Other||Odds Ratio (OR)|1.49||||0.7208|2-Sided|95.0|0.17|13.28|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680944|NCT01236053|3091992|Superiority or Other||Odds Ratio (OR)|1.71||||0.6252|2-Sided|95.0|0.2|14.84|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680945|NCT01236053|3091993|Superiority or Other||Odds Ratio (OR)|0.0||||0.9796|2-Sided|95.0|0.0|0.0|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680946|NCT01236053|3091993|Superiority or Other||Odds Ratio (OR)|0.0||||0.9798|2-Sided|95.0|0.0|0.0|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680947|NCT01236053|3091993|Superiority or Other||Odds Ratio (OR)|0.0||||0.9858|2-Sided|95.0|0.0|0.0|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680948|NCT01236053|3091993|Superiority or Other||Odds Ratio (OR)|0.0||||0.986|2-Sided|95.0|0.0|0.0|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680949|NCT01236053|3091993|Superiority or Other||Odds Ratio (OR)|0.0||||0.9857|2-Sided|95.0|0.0|0.0|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680950|NCT01236053|3091993|Superiority or Other||Odds Ratio (OR)|0.0||||0.9859|2-Sided|95.0|0.0|0.0|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680951|NCT01236053|3091993|Superiority or Other||Odds Ratio (OR)|1.08||||0.9467|2-Sided|95.0|0.13|9.02|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680952|NCT01236053|3091993|Superiority or Other||Odds Ratio (OR)|1.27||||0.8257|2-Sided|95.0|0.15|10.38|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680953|NCT01236053|3091994|Superiority or Other||Odds Ratio (OR)|0.43||||0.4147|2-Sided|95.0|0.06|3.27|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy.||
1680954|NCT01236053|3091994|Superiority or Other||Odds Ratio (OR)|0.49||||0.4933|2-Sided|95.0|0.07|3.72|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”.||
1680955|NCT01236053|3091995|Superiority or Other||Odds Ratio (OR)|0.93||||0.6772|2-Sided|95.0|0.64|1.34|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680956|NCT01236053|3091995|Superiority or Other||Odds Ratio (OR)|1.26||||0.1872|2-Sided|95.0|0.89|1.79|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680957|NCT01236053|3091995|Superiority or Other||Odds Ratio (OR)|0.8||||0.3984|2-Sided|95.0|0.47|1.35|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680958|NCT01236053|3091995|Superiority or Other||Odds Ratio (OR)|1.14||||0.5948|2-Sided|95.0|0.7|1.88|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680959|NCT01236053|3091995|Superiority or Other||Odds Ratio (OR)|2.04|||<|0.0001|2-Sided|95.0|1.48|2.81|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680960|NCT01236053|3091995|Superiority or Other||Odds Ratio (OR)|2.39|||<|0.0001|2-Sided|95.0|1.78|3.21|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680961|NCT01236053|3091995|Superiority or Other||Odds Ratio (OR)|1.03|||<|0.9069|2-Sided|95.0|0.59|1.82|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680962|NCT01236053|3091995|Superiority or Other||Odds Ratio (OR)|1.28|||<|0.3515|2-Sided|95.0|0.76|2.16|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680963|NCT01236053|3091995|Superiority or Other||Odds Ratio (OR)|1.7|||<|0.0006|2-Sided|95.0|1.25|2.29|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680964|NCT01236053|3091995|Superiority or Other||Odds Ratio (OR)|1.96|||<|0.0001|2-Sided|95.0|1.48|2.59|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680965|NCT01236053|3091995|Superiority or Other||Odds Ratio (OR)|1.01|||<|0.9625|2-Sided|95.0|0.62|1.65|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680966|NCT01236053|3091995|Superiority or Other||Odds Ratio (OR)|1.4|||<|0.1528|2-Sided|95.0|0.88|2.24|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680967|NCT01236053|3091996|Superiority or Other||Odds Ratio (OR)|0.9||||0.8497|2-Sided|95.0|0.31|2.64|||Conditional Logistic Regression||Comparison: “> 3 years (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680968|NCT01236053|3091996|Superiority or Other||Odds Ratio (OR)|1.14||||0.8087|2-Sided|95.0|0.4|3.21|||Conditional Logistic Regression||Comparison: “> 3 years (without 2 year lag)” and “Never (without 2 year lag)”.||
1680969|NCT01236053|3091996|Superiority or Other||Odds Ratio (OR)|1.87||||0.577|2-Sided|95.0|0.21|16.86|||Conditional Logistic Regression||Comparison: “> 3 years (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680970|NCT01236053|3091996|Superiority or Other||Odds Ratio (OR)|1.67||||0.6326|2-Sided|95.0|0.2|13.86|||Conditional Logistic Regression||Comparison: “> 3 years (with 2 year lag)” and “Never (with 2 year lag)”.||
1680971|NCT01236053|3091996|Superiority or Other||Odds Ratio (OR)|0.94||||0.8681|2-Sided|95.0|0.48|1.86|||Conditional Logistic Regression||Comparison: “> 2 years (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680972|NCT01236053|3091996|Superiority or Other||Odds Ratio (OR)|1.32||||0.4022|2-Sided|95.0|0.69|2.5|||Conditional Logistic Regression||Comparison: “> 2 years (without 2 year lag)” and “Never (without 2 year lag)”.||
1680973|NCT01236053|3091996|Superiority or Other||Odds Ratio (OR)|1.13||||0.8276|2-Sided|95.0|0.37|3.43|||Conditional Logistic Regression||Comparison: “> 2 years (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680974|NCT01236053|3091996|Superiority or Other||Odds Ratio (OR)|1.53||||0.435|2-Sided|95.0|0.53|4.42|||Conditional Logistic Regression||Comparison: “> 2 years (with 2 year lag)” and “Never (with 2 year lag)”.||
1680975|NCT01236053|3091996|Superiority or Other||Odds Ratio (OR)|0.85||||0.515|2-Sided|95.0|0.52|1.38|||Conditional Logistic Regression||Comparison: “> 1 year (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680976|NCT01236053|3091996|Superiority or Other||Odds Ratio (OR)|1.15||||0.5426|2-Sided|95.0|0.73|1.83|||Conditional Logistic Regression||Comparison: “> 1 year (without 2 year lag)” and “Never (without 2 year lag)”.||
1680977|NCT01236053|3091996|Superiority or Other||Odds Ratio (OR)|0.79||||0.507|2-Sided|95.0|0.39|1.58|||Conditional Logistic Regression||Comparison: “> 1 year (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680978|NCT01236053|3091996|Superiority or Other||Odds Ratio (OR)|1.23||||0.5394|2-Sided|95.0|0.63|2.39|||Conditional Logistic Regression||Comparison: “> 1 year (with 2 year lag)” and “Never (with 2 year lag)”.||
1680979|NCT01236053|3091997|Superiority or Other||Odds Ratio (OR)|1.02||||0.9286|2-Sided|95.0|0.71|1.45|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680980|NCT01236053|3091997|Superiority or Other||Odds Ratio (OR)|1.38||||0.0601|2-Sided|95.0|0.99|1.94|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680981|NCT01236053|3091997|Superiority or Other||Odds Ratio (OR)|0.84||||0.495|2-Sided|95.0|0.5|1.39|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680982|NCT01236053|3091997|Superiority or Other||Odds Ratio (OR)|1.23||||0.3972|2-Sided|95.0|0.76|2.0|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680983|NCT01236053|3091997|Superiority or Other||Odds Ratio (OR)|1.51||||0.0161|2-Sided|95.0|1.08|2.12|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680984|NCT01236053|3091997|Superiority or Other||Odds Ratio (OR)|1.84||||0.0001|2-Sided|95.0|1.35|2.52|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680985|NCT01236053|3091997|Superiority or Other||Odds Ratio (OR)|0.93||||0.8075|2-Sided|95.0|0.52|1.66|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680986|NCT01236053|3091997|Superiority or Other||Odds Ratio (OR)|1.08||||0.7794|2-Sided|95.0|0.63|1.85|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681012|NCT01236053|3092000|Superiority or Other||Odds Ratio (OR)|3.34||||0.2966|2-Sided|95.0|0.35|32.06|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680987|NCT01236053|3091997|Superiority or Other||Odds Ratio (OR)|2.05|||<|0.0001|2-Sided|95.0|1.53|2.76|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680988|NCT01236053|3091997|Superiority or Other||Odds Ratio (OR)|2.29|||<|0.0001|2-Sided|95.0|1.75|3.01|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680989|NCT01236053|3091997|Superiority or Other||Odds Ratio (OR)|1.05|||<|0.8357|2-Sided|95.0|0.64|1.73|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680990|NCT01236053|3091997|Superiority or Other||Odds Ratio (OR)|1.52|||<|0.0798|2-Sided|95.0|0.95|2.41|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680991|NCT01236053|3091998|Superiority or Other||Odds Ratio (OR)|1.09||||0.6262|2-Sided|95.0|0.77|1.54|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680992|NCT01236053|3091998|Superiority or Other||Odds Ratio (OR)|1.45||||0.0284|2-Sided|95.0|1.04|2.01|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680993|NCT01236053|3091998|Superiority or Other||Odds Ratio (OR)|0.82||||0.4505|2-Sided|95.0|0.49|1.38|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680994|NCT01236053|3091998|Superiority or Other||Odds Ratio (OR)|1.2||||0.4713|2-Sided|95.0|0.73|1.97|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680995|NCT01236053|3091998|Superiority or Other||Odds Ratio (OR)|1.34||||0.1629|2-Sided|95.0|0.89|2.0|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680996|NCT01236053|3091998|Superiority or Other||Odds Ratio (OR)|1.64||||0.0103|2-Sided|95.0|1.12|2.39|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1680997|NCT01236053|3091998|Superiority or Other||Odds Ratio (OR)|1.14||||0.6797|2-Sided|95.0|0.62|2.09|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1680998|NCT01236053|3091998|Superiority or Other||Odds Ratio (OR)|1.16||||0.6105|2-Sided|95.0|0.65|2.08|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1680999|NCT01236053|3091998|Superiority or Other||Odds Ratio (OR)|1.97|||<|0.0001|2-Sided|95.0|1.51|2.58|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1681000|NCT01236053|3091998|Superiority or Other||Odds Ratio (OR)|2.27|||<|0.0001|2-Sided|95.0|1.77|2.91|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681001|NCT01236053|3091998|Superiority or Other||Odds Ratio (OR)|0.94|||<|0.8016|2-Sided|95.0|0.59|1.5|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1681002|NCT01236053|3091998|Superiority or Other||Odds Ratio (OR)|1.41|||<|0.1184|2-Sided|95.0|0.92|2.18|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681003|NCT01236053|3091999|Superiority or Other||Odds Ratio (OR)|1.5|||<|0.0001|2-Sided|95.0|1.24|1.81|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1681004|NCT01236053|3091999|Superiority or Other||Odds Ratio (OR)|1.84|||<|0.0001|2-Sided|95.0|1.54|2.2|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”.||
1681005|NCT01236053|3091999|Superiority or Other||Odds Ratio (OR)|0.94|||<|0.671|2-Sided|95.0|0.69|1.27|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, COPD.||
1681006|NCT01236053|3091999|Superiority or Other||Odds Ratio (OR)|1.27|||<|0.0963|2-Sided|95.0|0.96|1.7|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”.||
1681007|NCT01236053|3092000|Superiority or Other||Odds Ratio (OR)|0.9||||0.9244|2-Sided|95.0|0.1|7.81|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681008|NCT01236053|3092000|Superiority or Other||Odds Ratio (OR)|4.33||||0.0944|2-Sided|95.0|0.78|24.07|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681009|NCT01236053|3092000|Superiority or Other||Odds Ratio (OR)|1.66||||0.7558|2-Sided|95.0|0.07|40.61|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681010|NCT01236053|3092000|Superiority or Other||Odds Ratio (OR)|6.71||||0.1868|2-Sided|95.0|0.4|113.4|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681011|NCT01236053|3092000|Superiority or Other||Odds Ratio (OR)|0.62||||0.751|2-Sided|95.0|0.03|12.31|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681172|NCT01235689|3092123|Superiority||Cox Proportional Hazard|1.337||||0.052|2-Sided|95.0|1.0|1.8|||Regression, Cox||||
1681013|NCT01236053|3092000|Superiority or Other||Odds Ratio (OR)|4.8||||0.0333|2-Sided|95.0|1.13|20.31|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681014|NCT01236053|3092000|Superiority or Other||Odds Ratio (OR)|3.86||||0.0524|2-Sided|95.0|0.99|15.14|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681015|NCT01236053|3092000|Superiority or Other||Odds Ratio (OR)|21.55||||0.0157|2-Sided|95.0|1.78|260.2|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681016|NCT01236053|3092000|Superiority or Other||Odds Ratio (OR)|20.0||||0.0144|2-Sided|95.0|1.81|220.5|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681017|NCT01236053|3092002|Superiority or Other||Odds Ratio (OR)|0.92||||0.9381||95.0|0.11|7.97|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681018|NCT01236053|3092002|Superiority or Other||Odds Ratio (OR)|4.33||||0.0944|2-Sided|95.0|0.78|24.07|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681019|NCT01236053|3092002|Superiority or Other||Odds Ratio (OR)|0.93||||0.9608|2-Sided|95.0|0.06|13.87|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681020|NCT01236053|3092002|Superiority or Other||Odds Ratio (OR)|3.75||||0.2885|2-Sided|95.0|0.33|43.08|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681021|NCT01236053|3092002|Superiority or Other||Odds Ratio (OR)|1.0||||0.999|2-Sided|95.0|0.03|32.21|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681022|NCT01236053|3092002|Superiority or Other||Odds Ratio (OR)|5.0||||0.1888|2-Sided|95.0|0.45|55.14|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681023|NCT01236053|3092002|Superiority or Other||Odds Ratio (OR)|8.56||||0.0063|2-Sided|95.0|1.83|40.02|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681024|NCT01236053|3092002|Superiority or Other||Odds Ratio (OR)|6.0||||0.0141|2-Sided|95.0|1.43|25.11|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681025|NCT01236053|3092002|Superiority or Other||Odds Ratio (OR)|21.47||||0.0158|2-Sided|95.0|1.78|258.8|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681026|NCT01236053|3092002|Superiority or Other||Odds Ratio (OR)|20.0||||0.0144|2-Sided|95.0|1.81|220.5|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681027|NCT01236053|3092003|Superiority or Other||Odds Ratio (OR)|0.9||||0.9253|2-Sided|95.0|0.1|7.82|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681028|NCT01236053|3092003|Superiority or Other||Odds Ratio (OR)|4.33||||0.0944|2-Sided|95.0|0.78|24.07|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681029|NCT01236053|3092003|Superiority or Other||Odds Ratio (OR)|0.93||||0.9608|2-Sided|95.0|0.06|13.87|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681030|NCT01236053|3092003|Superiority or Other||Odds Ratio (OR)|3.75||||0.2885|2-Sided|95.0|0.33|43.08|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681031|NCT01236053|3092003|Superiority or Other||Odds Ratio (OR)|1.0||||0.999|2-Sided|95.0|0.03|32.21|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681032|NCT01236053|3092003|Superiority or Other||Odds Ratio (OR)|5.0||||0.1888|2-Sided|95.0|0.45|55.14|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681033|NCT01236053|3092003|Superiority or Other||Odds Ratio (OR)|5.21||||0.0269|2-Sided|95.0|1.21|22.51|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681034|NCT01236053|3092003|Superiority or Other||Odds Ratio (OR)|3.86||||0.0524|2-Sided|95.0|0.99|15.14|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681035|NCT01236053|3092003|Superiority or Other||Odds Ratio (OR)|21.47||||0.0158|2-Sided|95.0|1.78|258.8|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681036|NCT01236053|3092003|Superiority or Other||Odds Ratio (OR)|20.0||||0.0144|2-Sided|95.0|1.81|220.5|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681037|NCT01236053|3092004|Superiority or Other||Odds Ratio (OR)|2.16||||0.209|2-Sided|95.0|0.65|7.17|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681038|NCT01236053|3092004|Superiority or Other||Odds Ratio (OR)|3.22||||0.0261|2-Sided|95.0|1.15|9.01|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”.||
1681039|NCT01236053|3092004|Superiority or Other||Odds Ratio (OR)|3.39||||0.1251|2-Sided|95.0|0.71|16.17|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, neuropathic pain, back pain, epilepsy, HIV, HPV (genital).||
1681040|NCT01236053|3092004|Superiority or Other||Odds Ratio (OR)|7.33||||0.0032|2-Sided|95.0|1.95|27.56|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”.||
1681041|NCT01236053|3092005|Superiority or Other||Odds Ratio (OR)|0.69||||0.4775|2-Sided|95.0|0.24|1.94|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681042|NCT01236053|3092005|Superiority or Other||Odds Ratio (OR)|0.86||||0.7743|2-Sided|95.0|0.31|2.4|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681043|NCT01236053|3092005|Superiority or Other||Odds Ratio (OR)|0.52||||0.3727|2-Sided|95.0|0.12|2.21|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681044|NCT01236053|3092005|Superiority or Other||Odds Ratio (OR)|0.66||||0.5728|2-Sided|95.0|0.16|2.79|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681045|NCT01236053|3092005|Superiority or Other||Odds Ratio (OR)|1.66||||0.2645|2-Sided|95.0|0.68|4.07|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681046|NCT01236053|3092005|Superiority or Other||Odds Ratio (OR)|1.91||||0.1498|2-Sided|95.0|0.79|4.62|||Unadjusted Odds Ratio||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681047|NCT01236053|3092005|Superiority or Other||Odds Ratio (OR)|1.12||||0.8557|2-Sided|95.0|0.33|3.84|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681048|NCT01236053|3092005|Superiority or Other||Odds Ratio (OR)|1.36||||0.6206|2-Sided|95.0|0.4|4.59|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681049|NCT01236053|3092005|Superiority or Other||Odds Ratio (OR)|0.55||||0.3226|2-Sided|95.0|0.17|1.79|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681050|NCT01236053|3092005|Superiority or Other||Odds Ratio (OR)|0.62||||0.431|2-Sided|95.0|0.19|2.01|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681051|NCT01236053|3092007|Superiority or Other||Odds Ratio (OR)|0.83||||0.6901|2-Sided|95.0|0.32|2.11|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681052|NCT01236053|3092007|Superiority or Other||Odds Ratio (OR)|1.0||||0.9932|2-Sided|95.0|0.4|2.53|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681053|NCT01236053|3092007|Superiority or Other||Odds Ratio (OR)|0.7||||0.5579|2-Sided|95.0|0.21|2.32|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681054|NCT01236053|3092007|Superiority or Other||Odds Ratio (OR)|0.84||||0.7807|2-Sided|95.0|0.26|2.77|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681055|NCT01236053|3092007|Superiority or Other||Odds Ratio (OR)|1.1||||0.8572|2-Sided|95.0|0.38|3.18|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681056|NCT01236053|3092007|Superiority or Other||Odds Ratio (OR)|1.33||||0.598|2-Sided|95.0|0.47|3.78|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681057|NCT01236053|3092007|Superiority or Other||Odds Ratio (OR)|1.07||||0.9273|2-Sided|95.0|0.24|4.84|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681058|NCT01236053|3092007|Superiority or Other||Odds Ratio (OR)|1.35||||0.6893|2-Sided|95.0|0.31|5.96|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681059|NCT01236053|3092007|Superiority or Other||Odds Ratio (OR)|0.77||||0.6216|2-Sided|95.0|0.27|2.17|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681060|NCT01236053|3092007|Superiority or Other||Odds Ratio (OR)|0.87||||0.7891|2-Sided|95.0|0.31|2.43|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681061|NCT01236053|3092008|Superiority or Other||Odds Ratio (OR)|0.51||||0.2642|2-Sided|95.0|0.16|1.66|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681062|NCT01236053|3092008|Superiority or Other||Odds Ratio (OR)|0.61||||0.4122|2-Sided|95.0|0.19|1.97|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681173|NCT01235689|3092124|Superiority||Cox Proportional Hazard|1.45||||0.008|2-Sided|95.0|1.1|1.9|||Regression, Cox||||
1681063|NCT01236053|3092008|Superiority or Other||Odds Ratio (OR)|0.74||||0.6263|2-Sided|95.0|0.22|2.46|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681064|NCT01236053|3092008|Superiority or Other||Odds Ratio (OR)|0.89||||0.849|2-Sided|95.0|0.27|2.92|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681065|NCT01236053|3092008|Superiority or Other||Odds Ratio (OR)|2.87||||0.0218|2-Sided|95.0|1.17|7.08|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681066|NCT01236053|3092008|Superiority or Other||Odds Ratio (OR)|3.53||||0.0049|2-Sided|95.0|1.47|8.5|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681067|NCT01236053|3092008|Superiority or Other||Odds Ratio (OR)|1.24||||0.7867|2-Sided|95.0|0.26|5.85|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681068|NCT01236053|3092008|Superiority or Other||Odds Ratio (OR)|1.75||||0.4733|2-Sided|95.0|0.38|8.06|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681069|NCT01236053|3092008|Superiority or Other||Odds Ratio (OR)|0.47||||0.2042|2-Sided|95.0|0.15|1.51|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681070|NCT01236053|3092008|Superiority or Other||Odds Ratio (OR)|0.53||||0.2875|2-Sided|95.0|0.17|1.7|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681071|NCT01236053|3092009|Superiority or Other||Odds Ratio (OR)|0.87||||0.6524|2-Sided|95.0|0.49|1.57|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681072|NCT01236053|3092009|Superiority or Other||Odds Ratio (OR)|1.03||||0.9142|2-Sided|95.0|0.58|1.84|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”.||
1681073|NCT01236053|3092009|Superiority or Other||Odds Ratio (OR)|0.54||||0.1845|2-Sided|95.0|0.21|1.34|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy, upper GI disorder, acid-suppressing drugs.||
1681074|NCT01236053|3092009|Superiority or Other||Unadjusted Odds Ratio|0.65||||0.3597|2-Sided|95.0|0.26|1.62|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”.||
1681075|NCT01236053|3092010|Superiority or Other||Odds Ratio (OR)|1.04||||0.4182|2-Sided|95.0|0.95|1.14|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681076|NCT01236053|3092010|Superiority or Other||Odds Ratio (OR)|1.13||||0.0103|2-Sided|95.0|1.03|1.24|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681077|NCT01236053|3092010|Superiority or Other||Odds Ratio (OR)|1.04||||0.5169|2-Sided|95.0|0.92|1.19|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681078|NCT01236053|3092010|Superiority or Other||Odds Ratio (OR)|1.14||||0.0469|2-Sided|95.0|1.0|1.29|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681079|NCT01236053|3092010|Superiority or Other||Odds Ratio (OR)|1.31|||<|0.0001|2-Sided|95.0|1.2|1.43|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681080|NCT01236053|3092010|Superiority or Other||Odds Ratio (OR)|1.42|||<|0.0001|2-Sided|95.0|1.3|1.55|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681081|NCT01236053|3092010|Superiority or Other||Odds Ratio (OR)|1.11|||<|0.1144|2-Sided|95.0|0.98|1.26|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681082|NCT01236053|3092010|Superiority or Other||Odds Ratio (OR)|1.2|||<|0.0062|2-Sided|95.0|1.05|1.36|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681083|NCT01236053|3092010|Superiority or Other||Odds Ratio (OR)|1.24|||<|0.0001|2-Sided|95.0|1.14|1.35|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681084|NCT01236053|3092010|Superiority or Other||Odds Ratio (OR)|1.34|||<|0.0001|2-Sided|95.0|1.23|1.45|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681085|NCT01236053|3092010|Superiority or Other||Odds Ratio (OR)|1.05|||<|0.4996|2-Sided|95.0|0.92|1.19|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681086|NCT01236053|3092010|Superiority or Other||Odds Ratio (OR)|1.12|||<|0.0709|2-Sided|95.0|0.99|1.28|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681087|NCT01236053|3092011|Superiority or Other||Odds Ratio (OR)|1.15||||0.2596|2-Sided|95.0|0.9|1.47|||Conditional Logistic Regression||Comparison: “> 3 years (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681088|NCT01236053|3092011|Superiority or Other||Odds Ratio (OR)|1.27||||0.0562|2-Sided|95.0|0.99|1.62|||Conditional Logistic Regression||Comparison: “> 3 years (without 2 year lag)” and “Never (without 2 year lag)”.||
1681089|NCT01236053|3092011|Superiority or Other||Odds Ratio (OR)|1.05||||0.8208|2-Sided|95.0|0.69|1.6|||Conditional Logistic Regression||Comparison: “> 3 years (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681090|NCT01236053|3092011|Superiority or Other||Odds Ratio (OR)|1.15||||0.5141|2-Sided|95.0|0.76|1.75|||Conditional Logistic Regression||Comparison: “> 3 years (with 2 year lag)” and “Never (with 2 year lag)”.||
1681091|NCT01236053|3092011|Superiority or Other||Odds Ratio (OR)|1.1||||0.254|2-Sided|95.0|0.93|1.3|||Conditional Logistic Regression||Comparison: “> 2 years (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681092|NCT01236053|3092011|Superiority or Other||Odds Ratio (OR)|1.21||||0.0257|2-Sided|95.0|1.02|1.43|||Conditional Logistic Regression||Comparison: “> 2 years (without 2 year lag)” and “Never (without 2 year lag)”.||
1681093|NCT01236053|3092011|Superiority or Other||Odds Ratio (OR)|1.16||||0.2649|2-Sided|95.0|0.89|1.52|||Conditional Logistic Regression||Comparison: “> 2 years (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681094|NCT01236053|3092011|Superiority or Other||Odds Ratio (OR)|1.27||||0.0775|2-Sided|95.0|0.97|1.65|||Conditional Logistic Regression||Comparison: “> 2 years (with 2 year lag)” and “Never (with 2 year lag)”.||
1681095|NCT01236053|3092011|Superiority or Other||Odds Ratio (OR)|1.02||||0.7243|2-Sided|95.0|0.91|1.15|||Conditional Logistic Regression||Comparison: “> 1 year (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681096|NCT01236053|3092011|Superiority or Other||Odds Ratio (OR)|1.12||||0.0762|2-Sided|95.0|0.99|1.26|||Conditional Logistic Regression||Comparison: “> 1 year (without 2 year lag)” and “Never (without 2 year lag)”.||
1681097|NCT01236053|3092011|Superiority or Other||Odds Ratio (OR)|1.09||||0.3132|2-Sided|95.0|0.92|1.29|||Conditional Logistic Regression||Comparison: “> 1 year (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681098|NCT01236053|3092011|Superiority or Other||Odds Ratio (OR)|1.2||||0.0369|2-Sided|95.0|1.01|1.41|||Conditional Logistic Regression||Comparison: “> 1 year (with 2 year lag)” and “Never (with 2 year lag)”.||
1681099|NCT01236053|3092012|Superiority or Other||Odds Ratio (OR)|1.07||||0.1477|2-Sided|95.0|0.98|1.17|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681100|NCT01236053|3092012|Superiority or Other||Odds Ratio (OR)|1.16||||0.0012|2-Sided|95.0|1.06|1.28|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681101|NCT01236053|3092012|Superiority or Other||Odds Ratio (OR)|1.07||||0.2731|2-Sided|95.0|0.95|1.22|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681102|NCT01236053|3092012|Superiority or Other||Odds Ratio (OR)|1.17||||0.0131|2-Sided|95.0|1.03|1.33|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681103|NCT01236053|3092012|Superiority or Other||Odds Ratio (OR)|1.25|||<|0.0001|2-Sided|95.0|1.14|1.36|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681104|NCT01236053|3092012|Superiority or Other||Odds Ratio (OR)|1.35|||<|0.0001|2-Sided|95.0|1.24|1.47|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681105|NCT01236053|3092012|Superiority or Other||Odds Ratio (OR)|1.1|||<|0.1592|2-Sided|95.0|0.96|1.25|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681106|NCT01236053|3092012|Superiority or Other||Odds Ratio (OR)|1.17|||<|0.0134|2-Sided|95.0|1.03|1.34|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681107|NCT01236053|3092012|Superiority or Other||Odds Ratio (OR)|1.26|||<|0.0001|2-Sided|95.0|1.16|1.38|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681108|NCT01236053|3092012|Superiority or Other||Odds Ratio (OR)|1.37|||<|0.0001|2-Sided|95.0|1.26|1.49|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681109|NCT01236053|3092012|Superiority or Other||Odds Ratio (OR)|1.03|||<|0.7004|2-Sided|95.0|0.9|1.17|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681110|NCT01236053|3092012|Superiority or Other||Odds Ratio (OR)|1.11|||<|0.1194|2-Sided|95.0|0.97|1.26|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681111|NCT01236053|3092013|Superiority or Other||Odds Ratio (OR)|1.1||||0.0464|2-Sided|95.0|1.0|1.2|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681112|NCT01236053|3092013|Superiority or Other||Odds Ratio (OR)|1.19||||0.0001|2-Sided|95.0|1.09|1.31|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681174|NCT01235689|3092125|Superiority||Cox Proportional Hazard|0.442||||0.012|2-Sided|95.0|0.2|0.8|||Regression, Cox||||
1681113|NCT01236053|3092013|Superiority or Other||Odds Ratio (OR)|1.07||||0.3366|2-Sided|95.0|0.94|1.21|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681114|NCT01236053|3092013|Superiority or Other||Odds Ratio (OR)|1.17||||0.019|2-Sided|95.0|1.03|1.33|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681115|NCT01236053|3092013|Superiority or Other||Odds Ratio (OR)|1.19||||0.0008|2-Sided|95.0|1.08|1.32|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681116|NCT01236053|3092013|Superiority or Other||Odds Ratio (OR)|1.29|||<|0.0001|2-Sided|95.0|1.16|1.43|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681117|NCT01236053|3092013|Superiority or Other||Odds Ratio (OR)|1.16|||<|0.0474|2-Sided|95.0|1.0|1.33|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681118|NCT01236053|3092013|Superiority or Other||Odds Ratio (OR)|1.24|||<|0.0033|2-Sided|95.0|1.07|1.43|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681119|NCT01236053|3092013|Superiority or Other||Odds Ratio (OR)|1.27|||<|0.0001|2-Sided|95.0|1.18|1.37|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681120|NCT01236053|3092013|Superiority or Other||Odds Ratio (OR)|1.37|||<|0.0001|2-Sided|95.0|1.27|1.48|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1681121|NCT01236053|3092013|Superiority or Other||Odds Ratio (OR)|1.01|||<|0.8545|2-Sided|95.0|0.9|1.14|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681122|NCT01236053|3092013|Superiority or Other||Odds Ratio (OR)|1.09|||<|0.1468|2-Sided|95.0|0.97|1.23|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1681123|NCT01236053|3092014|Superiority or Other||Odds Ratio (OR)|1.19|||<|0.0001|2-Sided|95.0|1.13|1.26|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681124|NCT01236053|3092014|Superiority or Other||Odds Ratio (OR)|1.29|||<|0.0001|2-Sided|95.0|1.23|1.36|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”||
1681125|NCT01236053|3092014|Superiority or Other||Odds Ratio (OR)|1.07|||<|0.0976|2-Sided|95.0|0.99|1.15|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, alcohol consumption, diabetes, neuropathic pain, back pain, epilepsy.||
1681126|NCT01236053|3092014|Superiority or Other||Odds Ratio (OR)|1.15|||<|0.0002|2-Sided|95.0|1.07|1.24|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”||
1681127|NCT01235949|3092062|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for protein D.|GMC ratio|0.87|||||2-Sided|99.8|0.64|1.17||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.|
1681128|NCT01235949|3092062|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for protein D.|GMC ratio|0.94|||||2-Sided|99.8|0.69|1.28||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.|
1681129|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.86|||||2-Sided|99.8|0.58|1.27||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.|
1681130|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||2-Sided|99.8|0.72|1.44||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.|
1681131|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.88|||||2-Sided|99.8|0.6|1.27||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.|
1681132|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.95|||||2-Sided|99.8|0.68|1.32||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 14.|
1681133|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.92|||||2-Sided|99.8|0.69|1.22||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.|
1681134|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||2-Sided|99.8|0.8|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.|
1681135|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.28|||||2-Sided|99.8|0.83|1.97||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.|
1681136|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.86|||||2-Sided|99.8|0.66|1.14||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 5.|
1681137|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.0|||||2-Sided|99.8|0.76|1.32||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 4.|
1681138|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.9|||||2-Sided|99.8|0.67|1.21||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 1.|
1681139|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.97|||||2-Sided|99.8|0.66|1.44||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.|
1681140|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.23|||||2-Sided|99.8|0.87|1.75||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.|
1681141|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.89|||||2-Sided|99.8|0.6|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.|
1681142|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.0|||||2-Sided|99.8|0.71|1.4||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 14.|
1681143|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.96|||||2-Sided|99.8|0.7|1.31||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.|
1681144|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.04|||||2-Sided|99.8|0.79|1.35||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.|
1681145|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.12|||||2-Sided|99.8|0.72|1.74||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.|
1681146|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.06|||||2-Sided|99.8|0.8|1.41||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 5.|
1681147|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|1.02|||||2-Sided|99.8|0.77|1.35||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 4.|
1681148|NCT01235949|3092063|Non-Inferiority|A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.|GMC ratio|0.96|||||2-Sided|99.8|0.71|1.29||||||At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 1.|
1681149|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|2.73|||||2-Sided|98.25|-5.3|11.04||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 23F.|
1681150|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.67|||||2-Sided|98.25|-3.4|5.2||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 19F.|
1681151|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||2-Sided|98.25|-5.08|3.54||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 18C.|
1681152|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.0|||||2-Sided|98.25|-4.08|4.12||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 14.|
1681153|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-1.27|||||2-Sided|98.25|-5.66|2.32||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 9V.|
1681154|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.0|||||2-Sided|98.25|-3.34|3.48||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 7F.|
1681155|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-2.38|||||2-Sided|98.25|-12.02|7.22||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 6B.|
1681156|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.64|||||2-Sided|98.25|-4.63|2.92||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 5.|
1681157|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.63|||||2-Sided|98.25|-4.57|2.91||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 4.|
1681158|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||2-Sided|98.25|-4.52|2.91||||||At one month after primary immunization, the difference between groups (NIBU minus DIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.|
1681175|NCT01235689|3092127|Superiority||LS Mean Difference|-1.4||||0.116|2-Sided|95.0|-3.2|0.4|||ANCOVA|Model included factors for treatment group, screening smoking status (yes or no), and weight (< 70 kg, ≥ 70 kg), and Baseline values as covariate.|||
1681176|NCT01235689|3092128|Superiority|||||||0.067|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (< 70 kg, ≥ 70 kg).|||
1681159|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.08||||||98.25|-7.66|8.1||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 23F.|
1681160|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.63|||||2-Sided|98.25|-4.6|3.14||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 19F.|
1681161|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.58|||||2-Sided|98.25|-5.04|3.85||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 18C.|
1681162|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.65|||||2-Sided|98.25|-4.68|3.15||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 14.|
1681163|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.58|||||2-Sided|98.25|-5.05|3.82||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 9V.|
1681164|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.65|||||2-Sided|98.25|-2.7|4.71||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 7F.|
1681165|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.69|||||2-Sided|98.25|-9.4|10.99||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 6B.|
1681166|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.64|||||2-Sided|98.25|-4.63|3.19||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 5.|
1681167|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: the upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|0.06|||||2-Sided|98.25|-3.94|4.38||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococcal serotype 4.|
1681168|NCT01235949|3092064|Non-Inferiority|Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.|Difference in percentages|-0.62|||||2-Sided|98.25|-4.52|3.17||||||At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.|
1681169|NCT01235689|3092112|Superiority||Cox Proportional Hazard|0.423||||0.212|2-Sided|95.0|0.1|1.6|||Regression, Cox||||
1681170|NCT01235689|3092119|Superiority||Cox Proportional Hazard|0.785||||0.459|2-Sided|95.0|0.4|1.5|||Regression, Cox||||
1681171|NCT01235689|3092120|Superiority||Cox Proportional Hazard|0.823||||0.501|2-Sided|95.0|0.5|1.5|||Regression, Cox||||
1681178|NCT01235689|3092130|Superiority|||||||0.299|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (< 70 kg, ≥ 70 kg).|||
1681179|NCT01235689|3092131|Superiority|||||||0.01|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (< 70 kg, ≥ 70 kg).|||
1681180|NCT01235689|3092132|Superiority|||||||0.006|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (< 70 kg, ≥ 70 kg).|||
1681181|NCT01235689|3092133|Superiority|||||||0.014|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening smoking status (yes or no) and weight (< 70 kg, ≥ 70 kg).|||
1681182|NCT01235689|3092134|Superiority|||||||0.01|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by Screening smoking status (yes or no) and weight (< 70 kg or ≥ 70 kg).|||
1681183|NCT01235598|3092135|Superiority or Other||Median Difference (Net)|0.0||||0.472|2-Sided|95.0|-2.0|1.0||Two-sided p-value is presented, with p <0.05 as the threshold for statistical significance.|Wilcoxon Rank-Sum Test||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.||
1681184|NCT01235598|3092136|Superiority or Other||Median Difference (Net)|0.0||||0.254|2-Sided|95.0|-1.0|0.0||Two-sided p-value is presented, with p <0.05 as the threshold for statistical significance.|Wilcoxon Rank-Sum Test||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.||
1681185|NCT01235598|3092137|Superiority or Other|||||||0.208|||||||Spearman rank correlation||||
1681186|NCT01235598|3092138|Superiority or Other|||||||0.411|||||||Spearman rank correlation||||
1681187|NCT01235598|3092139|Superiority or Other|||||||0.732|||||||Spearman rank correlation||||
1681188|NCT01235598|3092140|Superiority or Other|||||||0.128|||||||Spearman rank correlation||||
1681189|NCT01235598|3092141|Superiority or Other|||||||0.625|||||||Spearman rank correlation||||
1681190|NCT01235598|3092142|Superiority or Other|||||||0.394|||||||Spearman rank correlation||||
1681191|NCT01235598|3092154|Superiority or Other||Median difference within group changes|-421.5||||0.015|2-Sided|95.0|-1542.5|-47.0||Two-sided p-value is presented, with p <0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p <0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.|
1681192|NCT01235598|3092155|Superiority or Other||Median difference within group changes|-0.069||||0.865|2-Sided|95.0|-0.201|0.138||Two-sided p-value is presented, with p <0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p <0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.|
1681193|NCT01235598|3092156|Superiority or Other||Median difference within group changes|-0.0035||||0.164|2-Sided|95.0|-0.012|0.0025||Two-sided p-value is presented, with p <0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p <0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.|
1681194|NCT01235598|3092160|Superiority or Other||Median Difference within group changes|-1.0||||0.206|2-Sided|95.0|-3.0|1.0||Two-sided p-value is presented, with p < 0.05 as the threshold for statistical significance. A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p < 0.05). Hypothesis testing was stopped if and when a non-significant result was obtained. Testing was stopped in the next step.|
1681195|NCT01235598|3092161|Superiority or Other||Median difference within group changes|-1.5||||0.049|2-Sided|95.0|-3.0|0.0||Two-sided p-value is presented, with p < 0.05 as the threshold for statistical significance.|Permutation test with general scores||Hodges-Lehmann estimate of median difference and associated exact 95 % 2-sided confidence interval are provided.|A fixed-sequence stepwise hypothesis testing procedure was followed using a pre-specified set of ordered hypotheses. Hypotheses were ordered and tested in that order, beginning with change from Baseline at Week 16, and continuing to earlier time points (Week 8, 4, 2, 1 in that order) only if the previous null hypothesis of zero difference was rejected (p <0.05). Hypothesis testing was stopped if and when a non-significant result was obtained.|
1681196|NCT01235507|3092173|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 24|
1681197|NCT01235507|3092173|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 16|
1681198|NCT01235507|3092173|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 8|
1681199|NCT01235507|3092174|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 24|
1681203|NCT01235507|3092175|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 16|
1681204|NCT01235507|3092175|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 8|
1681205|NCT01235507|3092176|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 24|
1681206|NCT01235507|3092176|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 16|
1681207|NCT01235507|3092176|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 8|
1681208|NCT01235507|3092177|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 24|
1681209|NCT01235507|3092177|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 16|
1681210|NCT01235507|3092177|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 8|
1681211|NCT01235507|3092178|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 24|
1681212|NCT01235507|3092178|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 16|
1681213|NCT01235507|3092178|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 8|
1681214|NCT01235507|3092180|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 24|
1681215|NCT01235507|3092180|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 16|
1681216|NCT01235507|3092180|Superiority or Other||||||<|0.0005|||||||Wilcoxon signed rank test|||Change from Baseline to Week 8|
1681217|NCT01235442|3092181|Superiority or Other||Odds Ratio (OR)|1.34||||0.135|2-Sided|95.0|0.96|1.87||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=<35 or >35) and prior anti-TNF exposure (Yes or No).|||
1681218|NCT01235442|3092182|Superiority or Other||Odds Ratio (OR)|1.3||||0.135|2-Sided|95.0|0.92|1.85||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is adjusted for baseline BMI (=<35 or >35) and prior anti-TNF (Yes or No).|||
1681219|NCT01235442|3092183|Superiority or Other||||||<|0.001||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|van Elteren test|The test is stratified by baseline BMI (=<35 or >35) and prior anti-TNF exposure (Yes or No).|||
1681220|NCT01235442|3092184|Superiority or Other|||||||0.006||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=<35 or >35) and prior anti-TNF exposure (Yes or No) with with modified ridit scores.|||
1681221|NCT01235442|3092185|Superiority or Other||Odds Ratio (OR)|1.78||||0.009|2-Sided|95.0|1.21|2.64||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=<35 or >35) and prior anti-TNF exposure (Yes or No).|||
1681222|NCT01235442|3092186|Superiority or Other||Odds Ratio (OR)|1.96|||<|0.001|2-Sided|95.0|1.4|2.75||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI (=<35 or >35) and prior anti-TNF exposure (Yes or No).|||
1681223|NCT01235442|3092187|Superiority or Other||Odds Ratio (OR)|2.05|||<|0.001|2-Sided|95.0|1.46|2.87||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|The test is stratified by baseline BMI(=<35 or >35) and prior anti-TNF exposure(Yes or no).|||
1681224|NCT01235195|3092218|Superiority or Other||Ratio (%) of adjusted means|106.1|||||2-Sided|90.0|100.16|112.39|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed AUC (0-∞) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.|
1681225|NCT01235195|3092220|Superiority or Other||Ratio (%) of adjusted means|105.34|||||2-Sided|90.0|98.46|112.69|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed Cmax analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% CIs were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.|
1681226|NCT01235195|3092221|Superiority or Other||Ratio (%) of adjusted means|104.86|||||2-Sided|90.0|100.12|109.83|||||Reference treatment=Sertraline hydrochloride 50 mg hard gelatin capsule. Test treatment=sertraline hydrochloride 50 mg film-coated tablet.|Natural log-transformed AUC (0-72) analyzed using a mixed effect model with sequence, period, treatment as fixed effects; subject within sequence as a random effect. Estimates of adjusted mean differences (Test minus Reference) and corresponding 90% confidence intervals (CIs) were obtained from the model. Adjusted mean differences and 90% CIs for differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test divided by Reference) and 90% CIs for the ratios.|
1681227|NCT01234883|3092224|Superiority or Other||||||<|0.05|||||||ANOVA||||
1681228|NCT01234870|3092226|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The MR images resulting from two different image acquisition techniques, including Non-Corrected Breath-Hold Shallow-Breathing and Motion-Corrected, were assessed independently by two radiologists (average of 7 years of experience in reading cardiac MRI) using the American Heart Association modified 16 segment model and were evaluated using a four point Likert scale (1 = poor, 2 = fair, 3 = good, and 4 = excellent) for image quality|
1681229|NCT01234675|3092243|Superiority||Paired difference|-0.5||||0.425|2-Sided|95.0|-1.8|0.8|||Paired T test||||
1681230|NCT01234675|3092244|Superiority||Paired difference|-0.6||||0.305|2-Sided|95.0|-1.8|5.6|||Paired T test||||
1681231|NCT01234675|3092245|Superiority||Paired difference|-5.3||||0.349|2-Sided|95.0|-17.0|6.4|||Paired T test||||
1681232|NCT01234675|3092246|Superiority||Paired difference|-1.03||||0.685|2-Sided|95.0|-8.2|5.6|||Paired T test||||
1681233|NCT01234675|3092247|Superiority||Paired difference|0.32||||0.3|2-Sided|95.0|-0.3|0.6|||Paired T test||||
1681234|NCT01234675|3092248|Superiority||Paired difference|2.9||||0.509|2-Sided|95.0|-6.4|12.2|||Paired T test||||
1681235|NCT01234675|3092249|Superiority||Paired difference|-1.0||||0.844|2-Sided|95.0|-11.6|9.6|||Paired T test||||
1681236|NCT01234675|3092250|Superiority||Paired difference|-1.0||||0.805|2-Sided|95.0|-9.8|7.8|||Paired T test||||
1681237|NCT01234675|3092251|Superiority||Paired difference|-1.502||||0.155|2-Sided|95.0|-59.1|10.4|||Paired T test||||
1681238|NCT01234675|3092252|Superiority||Paired difference|-6.1||||0.683|2-Sided|95.0|-12.5|18.5|||Paired T test||||
1681239|NCT01234675|3092253|Superiority||Paired difference|22.6||||0.056|2-Sided|95.0|-0.6|45.8|||Paired T test||||
1681240|NCT01234675|3092254|Superiority||Paired difference|-6.1||||0.049|2-Sided|95.0|-12.2|-0.04|||Paired T test||||
1681241|NCT01234675|3092255|Superiority||Paired difference|4.6||||0.424|2-Sided|95.0|-7.3|16.6|||Paired T test||||
1681242|NCT01234649|3092256|Superiority||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA|
1681243|NCT01234649|3092257|Superiority||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA|
1681244|NCT01234649|3092258|Superiority||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA|
1681245|NCT01234649|3092259|Superiority||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA|
1681246|NCT01234649|3092260|Superiority||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA|
1681247|NCT01234649|3092261|Superiority||||||<|0.049|||||||ANOVA|||Factorial repeated measures ANOVA|
1681248|NCT01234649|3092262|Superiority||||||<|0.046|||||||ANOVA|||Factorial repeated measures ANOVA|
1681249|NCT01234649|3092263|Superiority||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA|
1681250|NCT01234649|3092264|Superiority||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA|
1681251|NCT01234649|3092265|Superiority||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA|
1681252|NCT01234649|3092266|Superiority|||||||0.042|||||||ANOVA|||Factorial repeated measures ANOVA|
1681253|NCT01234649|3092267|Superiority||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA|
1681254|NCT01234649|3092268|Superiority||||||<|0.023|||||||ANOVA|||Factorial repeated measures ANOVA|
1681255|NCT01234649|3092269|Superiority||||||<|0.047|||||||ANOVA|||Factorial repeated measures ANOVA|
1681256|NCT01234649|3092270|Superiority||||||<|0.04|||||||ANOVA||||
1681257|NCT01234649|3092271|Superiority||||||<|0.048|||||||ANOVA|||Factorial repeated measures ANOVA|
1681258|NCT01234649|3092272|Superiority||||||>|0.05|||||||ANOVA|||Factorial repeated measures ANOVA|
1681259|NCT01234649|3092273|Superiority||||||<|0.03|||||||ANOVA|||Factorial repeated measures ANOVA|
1681260|NCT01234649|3092274|Superiority||||||>|0.05|||||||ANOVA|||Nested repeated measures design|
1681261|NCT01234649|3092275|Superiority||||||<|0.011|||||||ANOVA|||Factorial repeated measures ANOVA|
1681262|NCT01234649|3092276|Superiority||||||<|0.005|||||||ANOVA|||Factorial repeated measures ANOVA|
1681263|NCT01234649|3092277|Superiority||||||<|0.04|||||||ANOVA|||Factorial repeated measures design|
1681264|NCT01234402|3092294|Other|||||||0.1743|||||||Fisher Exact||||
1681265|NCT01234402|3092294|Other|||||||0.6691|||||||Fisher Exact||||
1681266|NCT01234402|3092295|Other||Hazard Ratio (HR)|1.468||||0.155|2-Sided|95.0|0.862|2.501|||Log Rank||||
1681267|NCT01234402|3092295|Other||Hazard Ratio (HR)|1.833||||0.0283|2-Sided|95.0|1.06|3.169|||Log Rank||||
1681268|NCT01234402|3092296|Other||Hazard Ratio (HR)|1.48||||0.0851|2-Sided|95.0|0.938|2.335|||Log Rank|||Kaplan-Meier methodology estimated median PFS|
1681269|NCT01234402|3092296|Other||Hazard Ratio (HR)|0.691||||0.1315|2-Sided|95.0|0.429|1.114|||Log Rank|||Kaplan-Meier methodology estimated median PFS|
1681270|NCT01234350|3092297|Other||Odds Ratio (OR)|0.747||||0.0821|2-Sided|95.0|0.537|1.038||A logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group on the time to event for all-cause mortality.|Regression, Logistic|Logistic regression was used to model the influence of age, stage of disease and relevant medical history along with the treatment group.||The analyses of all-cause mortality was based on logistic regressions.|
1681271|NCT01234350|3092304|Other||IRR|2.623||||0.0208|2-Sided|95.0|1.158|5.944||Poisson-mixture regression is used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual trial exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit >1 suggest increased risk of AESI; upper confidence limit <1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For T2DM. The IRs were estimated using Poisson-mixture regression model.|
1681272|NCT01234350|3092304|Other||IRR|1.193||||0.2529|2-Sided|95.0|0.882|1.613||Poisson mixture regression was used to model the influence of age, stage of disease, and history of diabetes mellitus along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit >1 suggest increased risk of AESI; upper confidence limit <1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For glucose intolerance. The IRs were estimated using Poisson-mixture regression model.|
1681288|NCT01233869|3092353|Superiority or Other||Median Difference (Final Values)|4.95|||<|0.0001|2-Sided|95.0|2.65|7.3|||Mixed Models Analysis|||Statistical Analysis 5 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 400/200 mg/day.|
1681273|NCT01234350|3092305|Other||IRR|1.857||||0.4544|2-Sided|95.0|0.367|9.403||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit >1 suggest increased risk of AESI; upper confidence limit <1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For bone fracture events. The IRs were estimated using Poisson-mixture regression model.|
1681274|NCT01234350|3092305|Other||IRR|0.874||||0.671|2-Sided|95.0|0.47|1.626||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% CI, and IRRs with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit >1 suggest increased risk of AESI; upper confidence limit <1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|For osteoporosis and osteopenia events. The IRs were estimated using Poisson-mixture regression model.|
1681275|NCT01234350|3092306|Other||IRR|0.829||||0.4007|2-Sided|95.0|0.536|1.283||Poisson-mixture regression was used to model the influence of age, stage of disease, and relevant medical history along with the treatment group effect on the number of events adjusted for individual study exposures measured in 100 PYE.|Wald test|The IRs for each treatment arm with 95% confidence interval (CI), and incidence rate ratio (IRRs) with 95% CI and p-values were based on Wald test.|IRR for treatment with the lower 95% confidence limit >1 suggest increased risk of AESI; upper confidence limit <1 suggest decreased risk of AESI with the use of FIRMAGON. The limit including 1 suggests no difference b/w treatment groups.|The IRs were estimated using a Poisson-mixture regression model.|
1681276|NCT01234337|3092308|Superiority or Other||Ratio of geometric least square means|1.39|||||2-Sided|90.0|1.22|1.58||||||Statistical analysis for AUC(0-tlast): Capecitabine|
1681277|NCT01234337|3092308|Superiority or Other||Ratio of geometric least square means|1.11|||||2-Sided|90.0|0.95|1.3||||||Statistical analysis for AUC(0-tlast): 5-fluorouracil|
1681278|NCT01234337|3092309|Superiority or Other||Ratio of geometric least square means|1.29|||||2-Sided|90.0|1.07|1.56||||||Statistical analysis for Cmax: Capecitabine|
1681279|NCT01234337|3092309|Superiority or Other||Ratio of geometric least square means|1.14|||||2-Sided|90.0|0.92|1.4||||||Statistical analysis for Cmax: 5-fluorouracil|
1681280|NCT01234337|3092310|Superiority or Other||LSM Difference|-1.696|||||2-Sided|95.0|-3.619|0.227||||||Estimate of Difference (least squares mean [LSM] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.|
1681281|NCT01234337|3092311|Superiority or Other||LSM Difference|-0.025|||||2-Sided|95.0|-0.053|0.002||||||Estimate of Difference (least squares mean [LSM] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.|
1681282|NCT01234337|3092312|Superiority or Other||LSM Difference|-0.441|||||2-Sided|95.0|-0.967|0.086||||||Estimate of Difference (least squares mean [LSM] difference) = (Sorafenib + Capecitabine) - (Placebo + Capecitabine). The difference between the two treatment groups was evaluated with an analysis of covariance model using the baseline score and the same stratification factors as used for randomization (IVRS) as covariates.|
1681283|NCT01234337|3092314|Superiority or Other||Percent Difference|-2.34|||=|0|2-Sided|95.0|-10.4|5.72||One-sided p-value from Cochran-Mantel-Haenszel test (stratified per randomization as in IVRS).|Cochran-Mantel-Haenszel|||DCR and 95% CI based on “general association Cochran-Mantel-Haenszel statistic” with one-sided alpha of 0.025 stratified by number of prior chemotherapies for metastatic disease, hormone receptor status, and region. Difference = Placebo + Capecitabine - Sorafenib + Capecitabine.|
1681284|NCT01234337|3092315|Superiority or Other||Percent Difference|1.93|||=|0|2-Sided|95.0|-3.9|7.77||One-sided p-value from Cochran Mantel-Haenszel test (stratified per randomization as in IVRS)|Cochran-Mantel-Haenszel|||ORR and 95% CI based on Cochran Mantel-Haenszel Test stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. Difference = (Placebo + Capecitabine) - (Sorafenib + Capecitabine).|
1681285|NCT01234337|3092316|Superiority or Other||Hazard Ratio (HR)|0.91|||=|0|2-Sided|95.0|0.723|1.146||One-sided p-value from log rank test (stratified per randomization as in IVRS).|Log Rank||The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95% CIs were calculated using the Cox model, stratified by the above factors.|TTP was compared using a stratified log-rank test with a one-sided alpha of 0.025, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. A Hazard ratio <1 indicates superiority of Sorafenib+Capecitabine over Placebo+Capecitabine.|
1681286|NCT01234337|3092317|Superiority or Other||Hazard Ratio (HR)|1.195|||=|0|2-Sided|95.0|0.943|1.513||One-sided p-value from log rank test (stratified per randomization as in IVRS). OS was compared using a stratified log-rank test, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease.|Log Rank||The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95% CIs were calculated using the Cox model, stratified by randomization factors.|At the time of PFS final analysis, it was OS interim analysis (IA) with 285 total death events. According to protocol specified O'Brien-Fleming type alpha spending function and 285 death events at IA, the prespecified alpha for this analysis was 0.0075 (one-sided). A Hazard ratio < 1 indicates superiority of Sorafenib+Capecitabine over Placebo+Capecitabine.|
1681287|NCT01234337|3092318|Superiority or Other||Hazard Ratio (HR)|0.973|||=|0|2-Sided|95.0|0.779|1.217||One-sided p-value from log rank test (stratified per randomization as in interactive voice response system [IVRS]).|Log Rank|||PFS was compared using a stratified log-rank test with a one-sided alpha of 0.005, stratified by region, hormone receptor status, number of previous chemotherapies for metastatic disease. The hazard ratio (sorafenib + capecitabine / placebo + capecitabine) and its 95 percent (%) CIs were calculated using the Cox model, stratified by the above factors. A Hazard ratio of less than (<) 1 indicates superiority of Sorafenib + Capecitabine over Placebo + Capecitabine.|
1681289|NCT01233869|3092353|Superiority or Other||Median Difference (Final Values)|3.41|||<|0.1336|2-Sided|95.0|-1.03|8.05|||Mixed Models Analysis|||Statistical Analysis 4 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 400 mg/day.|
1681290|NCT01233869|3092353|Superiority or Other||Median Difference (Final Values)|3.06|||<|0.005|2-Sided|95.0|0.93|5.23|||Mixed Models Analysis|||Statistical Analysis 3 is comparison of annualized rate of kidney enlargement: placebo versus bosutinib 200 mg/day.|
1681291|NCT01233869|3092353|Superiority or Other||Median Difference (Final Values)|1.83|||<|0.1234|2-Sided|95.0|-0.5|4.22|||Mixed Models Analysis|||Statistical Analysis 2 is comparison of annualized rate of kidney enlargement: bosutinib 200 mg/day versus bosutinib 400/200 mg/day.|
1681292|NCT01233869|3092353|Superiority or Other||Median Difference (Final Values)|3.86|||<|0.0001|2-Sided|95.0|2.02|5.74|||Mixed Models Analysis|||Statistical Analysis 1 is comparison of annualized rate of kidney enlargement: placebo versus pooled bosutinib.|
1681293|NCT01233609|3092372|Superiority|||||||0.229|||||||Wilcoxon (Mann-Whitney)||||
1681294|NCT01233609|3092373|Superiority|||||||0.409|||||||Wilcoxon (Mann-Whitney)||||
1681295|NCT01233609|3092374|Superiority|||||||0.581|||||||Mixed Models Analysis||||
1681296|NCT01233609|3092375|Superiority||Mean Difference (Net)|-150.43|Standard Error of the Mean|71.37||0.035|2-Sided||||||Mixed Models Analysis|degrees of freedom = 830|Right eye and Left Eye within each of the 2 treatment groups (Placebo and Valproic Acid) were combined to estimate the difference||
1681297|NCT01233284|3092376|Superiority or Other||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.099||0.0815|2-Sided|95.0|-0.022|0.37|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h|
1681298|NCT01233284|3092376|Superiority or Other||Mean Difference (Final Values)|0.203|Standard Error of the Mean|0.099||0.0424|2-Sided|95.0|0.007|0.399|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h|
1681299|NCT01233284|3092376|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.099||0.3564|2-Sided|95.0|-0.104|0.287|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-24h|
1681300|NCT01233284|3092376|Superiority or Other||Mean Difference (Final Values)|0.181|Standard Error of the Mean|0.104||0.0855|2-Sided|95.0|-0.026|0.387|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h|
1681301|NCT01233284|3092376|Superiority or Other||Mean Difference (Final Values)|0.198|Standard Error of the Mean|0.104||0.0606|2-Sided|95.0|-0.009|0.404|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h|
1681302|NCT01233284|3092376|Superiority or Other||Mean Difference (Final Values)|0.067|Standard Error of the Mean|0.104||0.5207|2-Sided|95.0|-0.139|0.273|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC12-24h|
1681303|NCT01233284|3092376|Superiority or Other||Mean Difference (Final Values)|0.167|Standard Error of the Mean|0.099||0.0957|2-Sided|95.0|-0.03|0.363|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h|
1681304|NCT01233284|3092376|Superiority or Other||Mean Difference (Final Values)|0.209|Standard Error of the Mean|0.099||0.0379|2-Sided|95.0|0.012|0.405|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h|
1681305|NCT01233284|3092376|Superiority or Other||Mean Difference (Final Values)|0.116|Standard Error of the Mean|0.099||0.2451|2-Sided|95.0|-0.081|0.312|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-12h|
1681306|NCT01233284|3092377|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.078||0.0333|2-Sided|95.0|0.014|0.324|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h|
1681307|NCT01233284|3092377|Superiority or Other||Mean Difference (Final Values)|0.142|Standard Error of the Mean|0.078||0.0731|2-Sided|95.0|-0.014|0.297|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-24h|
1681308|NCT01233284|3092377|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.078||0.2062|2-Sided|95.0|-0.056|0.256|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-24h|
1681309|NCT01233284|3092377|Superiority or Other||Mean Difference (Final Values)|0.196|Standard Error of the Mean|0.084||0.022|2-Sided|95.0|0.029|0.363|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h|
1681310|NCT01233284|3092377|Superiority or Other||Mean Difference (Final Values)|0.136|Standard Error of the Mean|0.084||0.1097|2-Sided|95.0|-0.031|0.303|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC12-24h|
1681311|NCT01233284|3092377|Superiority or Other||Mean Difference (Final Values)|0.081|Standard Error of the Mean|0.084||0.3371|2-Sided|95.0|-0.086|0.249|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC12-24h|
1681312|NCT01233284|3092377|Superiority or Other||Mean Difference (Final Values)|0.142|Standard Error of the Mean|0.079||0.0766|2-Sided|95.0|-0.015|0.299|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h|
1681313|NCT01233284|3092377|Superiority or Other||Mean Difference (Final Values)|0.148|Standard Error of the Mean|0.079||0.0656|2-Sided|95.0|-0.01|0.305|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo|Comparison vs. Placebo for AUC0-12h|
1681314|NCT01233284|3092377|Superiority or Other||Mean Difference (Final Values)|0.118|Standard Error of the Mean|0.079||0.1402|2-Sided|95.0|-0.04|0.276||MMRM, adjusted for treatment, period, patient and study baseline.|Mixed Models Analysis||Tio R1.25 qd minus Placebo|Comparison vs. Placebo for AUC0-12h|
1681441|NCT01230749|3092747|Superiority or Other||Difference in LSM|-28.28||||0.005|2-Sided|95.0|-47.606|-8.957|||ANCOVA||||
1681315|NCT01233284|3092378|Superiority or Other||Mean Difference (Final Values)|-0.031|Standard Error of the Mean|0.032||0.3237||95.0|-0.094|0.031|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo||
1681316|NCT01233284|3092378|Superiority or Other||Mean Difference (Final Values)|-0.006|Standard Error of the Mean|0.032||0.8401||95.0|-0.069|0.056|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo||
1681317|NCT01233284|3092378|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.032||0.7501||95.0|-0.073|0.052|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo||
1681318|NCT01233284|3092379|Superiority or Other||Mean Difference (Final Values)|-0.087|Standard Error of the Mean|0.056||0.1163||95.0|-0.196|0.022|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo||
1681319|NCT01233284|3092379|Superiority or Other||Mean Difference (Final Values)|-0.068|Standard Error of the Mean|0.055||0.2191||95.0|-0.177|0.041|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo||
1681320|NCT01233284|3092379|Superiority or Other||Mean Difference (Final Values)|-0.084|Standard Error of the Mean|0.055||0.1303||95.0|-0.193|0.025|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo||
1681321|NCT01233284|3092380|Superiority or Other||Mean Difference (Final Values)|-0.111|Standard Error of the Mean|0.063||0.0781||95.0|-0.235|0.013|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo||
1681322|NCT01233284|3092380|Superiority or Other||Mean Difference (Final Values)|-0.138|Standard Error of the Mean|0.063||0.0288||95.0|-0.262|-0.014|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo||
1681323|NCT01233284|3092380|Superiority or Other||Mean Difference (Final Values)|-0.149|Standard Error of the Mean|0.063||0.0183||95.0|-0.273|-0.025|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo||
1681324|NCT01233284|3092381|Superiority or Other||Mean Difference (Final Values)|-0.201|Standard Error of the Mean|0.107||0.061||95.0|-0.41|0.009|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo||
1681325|NCT01233284|3092381|Superiority or Other||Mean Difference (Final Values)|-0.214|Standard Error of the Mean|0.107||0.0454||95.0|-0.424|-0.004|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo||
1681326|NCT01233284|3092381|Superiority or Other||Mean Difference (Final Values)|-0.233|Standard Error of the Mean|0.107||0.0296||95.0|-0.443|-0.023|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo||
1681327|NCT01233284|3092382|Superiority or Other||Mean Difference (Final Values)|-0.077|Standard Error of the Mean|0.636||0.9034||95.0|-1.327|1.173|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo||
1681328|NCT01233284|3092382|Superiority or Other||Mean Difference (Final Values)|-0.54|Standard Error of the Mean|0.635||0.3954||95.0|-1.789|0.708|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo||
1681329|NCT01233284|3092382|Superiority or Other||Mean Difference (Final Values)|-0.114|Standard Error of the Mean|0.635||0.8574||95.0|-1.363|1.134|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo||
1681330|NCT01233284|3092383|Superiority or Other||Mean Difference (Final Values)|21.581|Standard Error of the Mean|3.773|<|0.0001||95.0|14.166|28.997|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo||
1681331|NCT01233284|3092383|Superiority or Other||Mean Difference (Final Values)|14.577|Standard Error of the Mean|3.77|<|0.0001||95.0|7.166|21.988|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo||
1681332|NCT01233284|3092383|Superiority or Other||Mean Difference (Final Values)|21.251|Standard Error of the Mean|3.77|<|0.0001||95.0|13.84|28.662|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo||
1681333|NCT01233284|3092384|Superiority or Other||Mean Difference (Final Values)|20.846|Standard Error of the Mean|3.739|<|0.0001||95.0|13.497|28.195|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo||
1681334|NCT01233284|3092384|Superiority or Other||Mean Difference (Final Values)|17.895|Standard Error of the Mean|3.737|<|0.0001||95.0|10.55|25.24|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo||
1681335|NCT01233284|3092384|Superiority or Other||Mean Difference (Final Values)|18.55|Standard Error of the Mean|3.737|<|0.0001||95.0|11.204|25.895|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo||
1681336|NCT01233284|3092388|Superiority or Other||Mean Difference (Final Values)|0.138|Standard Error of the Mean|0.026|<|0.0001||95.0|0.086|0.189|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo||
1681337|NCT01233284|3092388|Superiority or Other||Mean Difference (Final Values)|0.075|Standard Error of the Mean|0.026|<|0.0043||95.0|0.024|0.126|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo||
1681338|NCT01233284|3092388|Superiority or Other||Mean Difference (Final Values)|0.064|Standard Error of the Mean|0.026|<|0.0149||95.0|0.013|0.115|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo||
1681339|NCT01233284|3092389|Superiority or Other||Mean Difference (Final Values)|0.098|Standard Error of the Mean|0.03||0.0012||95.0|0.039|0.157|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo||
1681340|NCT01233284|3092389|Superiority or Other||Mean Difference (Final Values)|0.072|Standard Error of the Mean|0.03||0.0177||95.0|0.012|0.131|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo||
1681341|NCT01233284|3092389|Superiority or Other||Mean Difference (Final Values)|0.054|Standard Error of the Mean|0.03||0.0732||95.0|-0.005|0.113|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo||
1681442|NCT01230749|3092748|Superiority or Other||Difference in LSM|-13.24||||0.178|2-Sided|95.0|-32.635|6.151|||ANCOVA||||
1681342|NCT01233284|3092390|Superiority or Other||Mean Difference (Final Values)|0.137|Standard Error of the Mean|0.027|<|0.0001||95.0|0.085|0.19|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo||
1681343|NCT01233284|3092390|Superiority or Other||Mean Difference (Final Values)|0.071|Standard Error of the Mean|0.027|<|0.0087||95.0|0.018|0.124|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo||
1681344|NCT01233284|3092390|Superiority or Other||Mean Difference (Final Values)|0.079|Standard Error of the Mean|0.027|<|0.0034||95.0|0.026|0.132|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo||
1681345|NCT01233284|3092391|Superiority or Other||Mean Difference (Final Values)|0.178|Standard Error of the Mean|0.023|<|0.0001||95.0|0.132|0.224|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo||
1681346|NCT01233284|3092391|Superiority or Other||Mean Difference (Final Values)|0.127|Standard Error of the Mean|0.023|<|0.0001||95.0|0.081|0.172|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo||
1681347|NCT01233284|3092391|Superiority or Other||Mean Difference (Final Values)|0.129|Standard Error of the Mean|0.023|<|0.0001||95.0|0.083|0.175|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo||
1681348|NCT01233284|3092392|Superiority or Other||Mean Difference (Final Values)|0.143|Standard Error of the Mean|0.024|<|0.0001||95.0|0.096|0.191|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo||
1681349|NCT01233284|3092392|Superiority or Other||Mean Difference (Final Values)|0.132|Standard Error of the Mean|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo||
1681350|NCT01233284|3092392|Superiority or Other||Mean Difference (Final Values)|0.125|Standard Error of the Mean|0.024|<|0.0001||95.0|0.078|0.173|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo||
1681351|NCT01233284|3092393|Superiority or Other||Mean Difference (Final Values)|0.188|Standard Error of the Mean|0.024|<|0.0001||95.0|0.14|0.236|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd minus Placebo||
1681352|NCT01233284|3092393|Superiority or Other||Mean Difference (Final Values)|0.128|Standard Error of the Mean|0.024|<|0.0001||95.0|0.08|0.176|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 qd minus Placebo||
1681353|NCT01233284|3092393|Superiority or Other||Mean Difference (Final Values)|0.138|Standard Error of the Mean|0.024|<|0.0001||95.0|0.09|0.186|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R1.25 qd minus Placebo||
1681354|NCT01233258|3092396|Non-Inferiority or Equivalence|Non-inferiority margin 10%|Median Difference (Net)|-0.0001||||0.0001|1-Sided|95.0|-0.049|||No multiplicity adjustment as not primary endpoint.|Exact Permutation Test for paired sample||Confidence interval calculated with exact Hodges- Lehmann estimates for CS/EP minus CS/ADJ|Null hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is less than the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. Alternative hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is greater than or equal to the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. No power calculation since this is not the primary comparison.|
1681355|NCT01233258|3092397|Superiority or Other|||||||0.0001|||||||ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.|
1681356|NCT01233258|3092398|Superiority or Other|||||||0.0001||||||No multiplicity adjustment as this is not primary endpoint.|ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.|
1681357|NCT01233258|3092399|Superiority or Other|||||||0.0001||||||No multiplicity adjustment as only 1 primary endpoint.|ANOVA|No adjustment, no transformation of data seemed to be necessary.||Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation: Assumption 5 bleeds per year on prophylactic treatment, 15 on on-demand treatment; 2-sided alpha 5% and 90% power.|
1681358|NCT01232946|3092424|Superiority|||||||0.8|||||||Kruskal-Wallis||||
1681359|NCT01232946|3092425|Superiority|||||||0.065|||||||Kruskal-Wallis||||
1681360|NCT01232946|3092426|Superiority|||||||0.65|||||||Kruskal-Wallis||||
1681361|NCT01232920|3092430|Superiority or Other|||||||0.09|||||||Fisher Exact||||
1681362|NCT01232738|3092468|Superiority|||||||0.58|||||||Log Rank||||
1681363|NCT01232738|3092469|Superiority||Mean Difference (Final Values)|-0.25||||0.07|2-Sided|95.0|-0.53|0.02|||Chi-squared|||Difference in slope of decline|
1681364|NCT01232569|3092486|Superiority or Other||Mean Difference (Final Values)|29.5|||<|0.001|2-Sided|95.0|22.0|37.0|||Cochran-Mantel-Haenszel|Analysis adjusted for the randomization stratification factors applied at Baseline (region and weight category).|||
1681365|NCT01232556|3092488|Superiority or Other||Mean Difference (Final Values)|3.11||||0.1879|2-Sided|95.0|-1.52|7.74|||Mixed Models Analysis|Repeated measures mixed effects model with treatment, time, treatment-by-time interaction, and baseline as covariate.|||
1681366|NCT01232556|3092489|Superiority or Other||Mean Difference (Final Values)|0.02||||0.2892|2-Sided|95.0|-0.02|0.06|||Mixed Models Analysis|Repeated measures mixed effects model with treatment, time, treatment-by-time interaction, and baseline as covariate.|||
1681367|NCT01232556|3092490|Superiority or Other||Hazard Ratio (HR)|0.76||||0.142|2-Sided|95.0|0.47|1.25|||Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.|DOR was not part of the formal hypothesis testing strategy.|
1681368|NCT01232556|3092491|Superiority or Other|||||||0.714||||||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Cochran-Mantel-Haenszel|The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.||Third comparison in hierarchical testing strategy was used for power calculation.|
1681369|NCT01232556|3092492|Superiority or Other|||||||0.843||||||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Cochran-Mantel-Haenszel|The stratification factors are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.||Third comparison in hierarchical testing strategy was used for power calculation.|
1681370|NCT01232556|3092493|Superiority or Other||Hazard Ratio (HR)|0.924||||0.271|2-Sided|95.0|0.72|1.19||An hierarchical testing strategy was specified for OS, PFS and response. PFS could be tested at the 0.023 level if the OS test result were positive. Response could be tested if both the OS and PFS test results were positive.|Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are are pre-randomization investigator choice, baseline sIPI, and best response to most recent chemo therapy.|Second comparison in hierarchical testing strategy was used for power calculation.|
1681371|NCT01232556|3092494|Superiority or Other||Hazard Ratio (HR)|1.083||||0.708|2-Sided|95.0|0.82|1.44||A one sided 0.025 level testing plan was specified with two interim analyses and final testing level at one-sided 0.023.|Log Rank|From one sided stratified log-rank test.|From stratified Cox proportional hazards model. The stratification factors are are pre-randomization investigator choice, baseline Secondary International Prognostic Index (sIPI), and best response to most recent chemo therapy.|Primary null hypothesis: Equality of survival distributions. Sample size sufficient to have power 0.96 for an experimental/control hazard ratio of 0.6.|
1681372|NCT01232491|3092507|Superiority or Other||Estimated treatment difference, LS Mean|0.07||||0.674||95.0|-0.25|0.39|||Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and FPG at baseline as covariate.|
1681373|NCT01232491|3092508|Superiority or Other||Estimated treatment difference, LS Mean|0.13||||0.053||95.0|0.0|0.26|||Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening and region as factors and HbA1c at baseline as covariate.|
1681374|NCT01232491|3092509|Superiority or Other||Estimated treatment difference, LS Mean|0.17||||0.137||95.0|-0.05|0.39|||Regression, Linear|||Normal linear regression model with treatment, use of insulin secretagogue at screening, sex and region as factors, and age and BMI at baseline as covariates.|
1681375|NCT01232491|3092510|Superiority or Other||Estimated treatment difference, LS Mean|0.49||||0.132||95.0|-0.15|1.13||If the p-value for the two-sided test was less than 5%, and D (the estimated treatment difference [dietary intervention versus no dietary intervention]) was less than 0 then superiority for dietary intervention was considered confirmed.|Regression, Linear|||Normal linear regression model with treatment, strata, use of insulin secretagogue at screening, sex and region as factors and age and weight at baseline as covariates. Superiority was considered confirmed if the upper bound of the two-sided 95% CI for the estimated treatment difference (dietary intervention versus no dietary intervention), which was calculated using the FAS, was below 0 kg.|
1681376|NCT01232452|3092522|Superiority|||||||0.338|||||||Fisher Exact||||
1681377|NCT01232452|3092523|Superiority||Hazard Ratio (HR)|1.03||||0.848|2-Sided|95.0|0.73|1.47|||Log Rank||||
1681378|NCT01232283|3092535|Superiority or Other (legacy)||Hazard Ratio (HR)|7.7|||<|0.0001|2-Sided|95.0|3.408|17.399|||Log Rank||||
1681379|NCT01232283|3092536|Superiority or Other (legacy)||Risk Difference (RD)|14.2|||<|0.0001|2-Sided|95.0|8.5|20.0|||Chi-squared||||
1681380|NCT01232283|3092537|Superiority or Other (legacy)||LS Mean Difference|2.63||||0.0078|2-Sided|95.0|0.69|4.56|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.|||
1681381|NCT01232283|3092538|Superiority or Other (legacy)||LS Mean Difference|-4.0|||<|0.0001|2-Sided|95.0|-5.3|-2.8|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.|||
1681382|NCT01232283|3092539|Superiority or Other (legacy)||LS Mean Difference|-21.3|||<|0.0001|2-Sided|95.0|-28.4|-14.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.|||
1681383|NCT01232283|3092540|Superiority or Other (legacy)||Risk Difference (RD)|35.8|||<|0.0001|2-Sided|95.0|26.9|44.7|||Chi-squared||||
1681384|NCT01232283|3092541|Superiority or Other (legacy)||LS Mean Difference|-34.8|||<|0.0001|2-Sided|95.0|-42.4|-27.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.|||
1681385|NCT01232283|3092542|Superiority or Other (legacy)||Difference in LS Mean|-42.15|||<|0.0001|2-Sided|95.0|-51.11|-33.2|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.|||
1681386|NCT01232283|3092543|Superiority or Other (legacy)||Risk Difference (RD)|16.1|||<|0.0001|2-Sided|95.0|10.2|21.9|||Chi-squared||||
1681387|NCT01232283|3092544|Superiority or Other (legacy)||Risk Difference (RD)|23.0|||<|0.0001|2-Sided|95.0|16.3|29.6|||Chi-squared||||
1681388|NCT01231984|3092556|Non-Inferiority or Equivalence|Two one-sided 95% confidence limits for the difference in HbA1c between the 4mm PN and the 12.7mm PN was calculated. Equivalence limits for HbA1C were defined a-priori as +/- 0.4% units|Effect of 4 mm vs.12.7mm PN on HbA1c|0.0|||||2-Sided|95.0|-0.19|0.0||||||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.|
1681389|NCT01231984|3092558|Superiority or Other||Mean Difference (Final Values)|30.83|||<|0.05|1-Sided|95.0|18.54|||p< 0.05 was considered statistically significant in this study.|t-test, 1 sided||||
1681390|NCT01231984|3092559|Superiority or Other||Mean Difference (Final Values)|12.36|||<|0.05|1-Sided|95.0|0.37|||p< 0.05 was considered statistically significant in this study|t-test, 1 sided|||"Subjects rated the level of pain experienced when using the PN assigned for use during Study Period 2 compared to the PN assigned for use in Study Period 1. By placing a mark on a line, whose midpoint(anchor) was designated as 0, and represented equivalent pain with assigned PNs, ratings on the continuum represented the degree to which the PN used in the second Study Period was less than or greater than the PN used during the first Study Period."|
1681443|NCT01230749|3092748|Superiority or Other||Difference in LSM|-20.47||||0.038|2-Sided|95.0|-39.801|-1.142|||ANCOVA||||
1681391|NCT01231984|3092560|Non-Inferiority or Equivalence|Two one-sided 95% confidence limits for the difference in HbA1c between the 4 mm PN and the longer PNs (pooled) was calculated. Equivalence limits for HbA1c were defined a-priori as +/- 0.4% units.|Effect of 4mm PN vs. longer PN on HbA1c|-0.09|||||2-Sided|95.0|-0.23|0.051||||||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.|
1681392|NCT01231984|3092561|Non-Inferiority or Equivalence|Two one-sided 95% confidence limits for the difference in HbA1c between the 4mm PN and the 8mm PN was calculated. Equivalence limits for HbA1C were defined a-priori as +/- 0.4% units.|Effect of 4mm versus 8mm PN on HbA1c|-0.076|||||2-Sided|95.0|-0.209|0.058||||||General linear models with baseline as a covariate, needle type, period, and randomization sequence as fixed effects, and subject as random effect were fit to the data.|
1681393|NCT01231620|3092606|Superiority or Other|||||||0.41|||||||Wei-Johnson method||||
1681394|NCT01231620|3092606|Superiority or Other|||||||0.506|||||||Wei-Johnson method||||
1681395|NCT01231620|3092607|Superiority or Other||Median Difference (Final Values)|-0.48||||0.39|2-Sided|95.0|-2.11|0.97|||Wilcoxon rank sum||Oral oseltamivir 75 mg versus IV Zanamivir 600 mg||
1681396|NCT01231620|3092607|Superiority or Other||Median Difference (Final Values)|-0.73||||0.25|2-Sided|95.0|-1.79|0.75|||Wilcoxon rank sum||IV Zanamivir 300 mg versus IV Zanamivir 600 mg||
1681397|NCT01231607|3092624|Superiority or Other||Least squares mean difference|33.0||||0.003|2-Sided|98.33|6.1|60.0|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.||
1681398|NCT01231607|3092624|Superiority or Other||Least squares mean difference|6.5||||0.56|2-Sided|98.33|-20.1|33.1|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.||
1681399|NCT01231607|3092624|Superiority or Other||Least squares mean difference|-39.4|||<|0.001|2-Sided|98.33|-66.1|-12.7|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.||
1681400|NCT01231607|3092624|Non-Inferiority or Equivalence|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|33.0|||<|0.002||99.165|6.1|60.0|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.5 mg LS mean.||
1681401|NCT01231607|3092624|Non-Inferiority or Equivalence|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|6.5|||<|0.28||99.165|-20.1|33.1|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.1 mg LS mean.||
1681402|NCT01231607|3092624|Non-Inferiority or Equivalence|Differences between dutasteride (DUT) and finasteride (FIN) were assessed using a general linear model (GLM) adjusted for treatment, cluster, and BL hair count (HC). The one-sided 99.165% confidence interval (CI) for DUT minus FIN was derived, and noninferiority (NI) demonstrated if the lower end of the CI was greater than -35 hairs. If NI was achieved with a dose of DUT, the primary endpoint was to be analyzed for superiority against FIN using a GLM adjusted for treatment, cluster, and BL HC.|Least squares mean difference|-39.4|||<|0.001||99.165|-66.1|-12.7|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the Dutasteride 0.02 mg LS mean.||
1681403|NCT01231607|3092624|Superiority or Other||Least squares mean difference|61.4|||<|0.001|2-Sided|98.33|34.4|88.4|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the finasteride 1 mg LS mean minus the placebo LS mean.||
1681404|NCT01231607|3092624|Superiority or Other||LS mean difference|94.4|||<|0.001|2-Sided|98.33|67.8|121.0|||General linear model|Each dose of dutasteride independently analyzed for comparison against placebo using a general linear model.|Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.5 mg LS mean minus the placebo LS mean.||
1681405|NCT01231607|3092624|Superiority or Other||LS mean difference|67.9|||<|0.001|2-Sided|98.33|41.6|94.2|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.1 mg LS mean minus the placebo LS mean.||
1681406|NCT01231607|3092624|Superiority or Other||Least-squares (LS) mean difference|22.0|||<|0.046|2-Sided|98.33|-4.4|48.4|||General linear model||Estimates are based on the adjusted (least-squares) means from the general linear model: Change from Baseline = Treatment + Cluster + Baseline Value. The estimation value represents the dutasteride 0.02 mg LS mean minus the placebo LS mean.||
1681407|NCT01231581|3092631|Superiority or Other||Hazard Ratio (HR)|0.94||||0.352|2-Sided|95.0|0.66|1.32|||Log Rank||Hazard ratios are estimated using a Pike estimator.||
1681444|NCT01230749|3092748|Superiority or Other||Difference in LSM|-27.4||||0.006|2-Sided|95.0|-46.792|-8.008|||ANCOVA||||
1681408|NCT01231516|3092649|Non-Inferiority or Equivalence (legacy)|Non-inferiority of DTG 50 mg and RAL at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - RAL) is greater than -12%. If non-inferiority were established, superiority would be tested at the nominal 5% level based on a pre-specified testing procedure.|Difference in percentage|7.4||||0.03|2-Sided|95.0|0.7|14.2||P-value is for test of superiority.|Cochran-Mantel-Haenszel|Adjusted difference in proportion which is based on the difference in percentage, adjusted for Baseline (BL) stratification factors.|Analysis was adjusted for the BL stratification factors: HIV-1 RNA (<=50000 vs > 50000 c/mL), darunavir-ritonavir use without primary protease inhibitor mutations (yes vs no), and phenotypic susceptibility score (2 vs <2) to background regimen.||
1681409|NCT01231464|3092684|Superiority or Other||Least Squares Mean Difference|-1.498|||<|0.0001|2-Sided|95.0|-1.897|-1.009|||ANCOVA||Besides treatment, the ANCOVA analysis also adjusted for baseline, center, gender, age, and classification of AR (Intermittent Allergic Rhinitis [IAR] or Persistent Allergic Rhinitis [PER]).||
1681410|NCT01231373|3092695|Superiority or Other||Mean Difference (Final Values)|-1.47|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-1.83|-1.11|||ANCOVA||||
1681411|NCT01231373|3092695|Superiority or Other||Mean Difference (Final Values)|-1.54|Standard Error of the Mean|0.129|<|0.0001|2-Sided|95.0|-1.9|-1.18|||ANCOVA||||
1681412|NCT01231373|3092695|Superiority or Other||Mean Difference (Final Values)|-1.23|Standard Error of the Mean|0.131|<|0.0001|2-Sided|95.0|-1.59|-0.87|||ANCOVA||||
1681413|NCT01231373|3092696|Superiority or Other||Mean Difference (Final Values)|-0.75|||<|0.0001|2-Sided|95.0|-0.97|-0.54|||ANCOVA||||
1681414|NCT01231373|3092696|Superiority or Other||Mean Difference (Final Values)|-0.82|Standard Error of the Mean|0.078|<|0.0001|2-Sided|95.0|-1.04|-0.61|||ANCOVA||||
1681415|NCT01231373|3092696|Superiority or Other||Mean Difference (Final Values)|-0.66|Standard Error of the Mean|0.081|<|0.0001|2-Sided|95.0|-0.88|-0.45|||ANCOVA||||
1681416|NCT01231373|3092697|Superiority or Other||Mean Difference (Final Values)|-3.05|||<|0.0001|2-Sided|95.0|-4.33|-1.77|||ANCOVA||||
1681417|NCT01231373|3092697|Superiority or Other||Mean Difference (Final Values)|-4.0|||<|0.0001|2-Sided|95.0|-5.26|-2.74|||ANCOVA||||
1681418|NCT01231373|3092697|Superiority or Other||Mean Difference (Final Values)|-3.34|||<|0.0001|2-Sided|95.0|-4.63|-2.04|||ANCOVA|||Comparison of polidocanol treatment groups versus placebo (absolute change from baseline to week 8 in patient assessment of symptoms of varicose veins (VVSymQ) score.|
1681419|NCT01231230|3092710|Superiority or Other||||||>|0.05|||||||ANOVA|||mean difference from baseline relative to placebo|
1681420|NCT01231230|3092710|Superiority or Other||||||<|0.001|||||||ANOVA|||mean difference from baseline relative to placebo|
1681421|NCT01231230|3092710|Superiority or Other||Mean Difference (Final Values)|15.0|||<|0.001|2-Sided||||||ANOVA|||mean difference from baseline relative to placebo|
1681422|NCT01230814|3092727|Superiority or Other||Risk Ratio (RR)|0.65||||0.005|2-Sided|95.0|0.48|0.87||The a priori threshold for statistical significance for BV was p<0.030 (two-sided).|clutstered chi-squared statistic||For the relative risk estimate, the metronidazole plus miconazole arm represented the numerator and the placebo arm represented the denominator such that a relative risk <1 indicates a lower percentage of test visits in the treated arm.|Each participant within a study arm was considered a cluster, with observations at a maximum of 6 visits. The percentage of visits at which BV was detected was compared between metronidazole plus miconazole arm versus placebo arm using a chi-squared statistic adjusted for clustering using the method of Donner and Klar (2000).|
1681423|NCT01230814|3092728|Superiority or Other||Risk Ratio (RR)|0.92||||0.69|2-Sided|95.0|0.62|1.37||The a priori threshold for statistical significance for VVC was p<0.020 (two-sided).|Clustered chi-squared statistic||For the relative risk estimate, the metronidazole plus miconazole arm represented the numerator and the placebo arm represented the denominator such that a relative risk <1 indicates a lower percentage of positive test visits in the treated arm.|Each participant within a study arm was considered a cluster, with observations at a maximum of 6 visits. The percentage of visits at which VVC was detected was compared between metronidazole plus miconazole arm versus placebo arm using a chi-squared statistic adjusted for clustering using the method of Donner and Klar (2000).|
1681424|NCT01230749|3092741|Superiority or Other||Difference in LSM|1.02||||0.022|2-Sided|95.0|0.15|1.892|||ANCOVA||||
1681425|NCT01230749|3092741|Superiority or Other||Difference in LSM|0.03||||0.941|2-Sided|95.0|-0.838|0.904|||ANCOVA||||
1681426|NCT01230749|3092741|Superiority or Other||Difference in LSM|0.46||||0.295|2-Sided|95.0|-0.408|1.323|||ANCOVA||||
1681427|NCT01230749|3092742|Superiority or Other||GMR mulitplied by 100 percent|101.82||||0.917|2-Sided|90.0|76.26|135.942|||ANCOVA||||
1681428|NCT01230749|3092742|Superiority or Other||GMR multiplied by 100 percent|133.27||||0.097|2-Sided|90.0|100.275|177.115|||ANCOVA||||
1681429|NCT01230749|3092743|Superiority or Other||GMR multiplied by 100 percent|101.18||||0.785|2-Sided|90.0|94.179|108.7|||ANCOVA||||
1681430|NCT01230749|3092743|Superiority or Other||GMR multiplied by 100 percent|100.17||||0.968|2-Sided|90.0|93.217|107.647|||ANCOVA||||
1681431|NCT01230749|3092744|Superiority or Other||GMR multiplied by 100 percent|89.9||||0.555|2-Sided|90.0|66.567|121.403|||ANCOVA||||
1681432|NCT01230749|3092744|Superiority or Other||GMR mulitplied by 100 percent|95.1||||0.774|2-Sided|90.0|71.031|127.324|||ANCOVA||||
1681433|NCT01230749|3092745|Superiority or Other||Difference in LSM|-0.69||||0.444|2-Sided|95.0|-2.463|1.091|||ANCOVA||||
1681434|NCT01230749|3092745|Superiority or Other||Difference in LSM|-0.26||||0.769|2-Sided|95.0|-2.033|1.509|||ANCOVA||||
1681435|NCT01230749|3092745|Superiority or Other||Difference in LSM|-1.86||||0.041|2-Sided|95.0|-3.634|-0.082|||ANCOVA||||
1681436|NCT01230749|3092746|Superiority or Other||Difference in LSM|5.87||||0.303|2-Sided|95.0|-5.417|17.148|||ANCOVA||||
1681437|NCT01230749|3092746|Superiority or Other||Difference in LSM|13.7||||0.018|2-Sided|95.0|2.392|25.008|||ANCOVA||||
1681438|NCT01230749|3092746|Superiority or Other||Difference in LSM|2.76||||0.628|2-Sided|95.0|-8.542|14.054|||ANCOVA||||
1681439|NCT01230749|3092747|Superiority or Other||Difference in LSM|-17.71||||0.069|2-Sided|95.0|-36.86|1.431|||ANCOVA||||
1681440|NCT01230749|3092747|Superiority or Other||Difference in LSM|-21.97||||0.025|2-Sided|95.0|-41.154|-2.786|||ANCOVA||||
1681445|NCT01229943|3092803|Superiority or Other (legacy)||Hazard Ratio (HR)|0.8||||0.12|2-Sided|95.0|0.55|1.17||Tests were stratified by: prior treatment with cytotoxic chemotherapy (no vs yes), prior use of octreotide (no vs yes), and prior therapy with sunitinib (no vs yes).|Log Rank|||Based on the log rank test, with 130 patients enrolled over 22 months and followed an additional 24 months, the difference in median PFS between 9 months and 14 months can be detected with approximately 90% power (1-sided, α=0.15).|
1681446|NCT01229735|3092816|Superiority or Other||Odds Ratio (OR)|1.1|||=|0|2-Sided|95.0|0.7|1.7||P-value is from likelihood ratio test of treatment group regression coefficient against 0.|Regression, Logistic|||The Odds Ratio (OR) for LEV vs TPM is based on logistic regression modeling of subject retention by treatment and center pooling category. A profile likelihood confidence interval for the OR is presented.|
1681447|NCT01229449|3092832|Superiority||||||<|0.0001|||||||ANOVA||||
1681448|NCT01229449|3092832|Superiority||||||<|0.0001|||||||ANOVA||||
1681449|NCT01229449|3092832|Superiority||||||<|0.0005|||||||ANOVA||||
1681450|NCT01229449|3092832|Superiority||||||<|0.0005|||||||ANOVA||||
1681451|NCT01229449|3092832|Superiority||||||<|0.0001|||||||ANOVA||||
1681452|NCT01229449|3092832|Superiority||||||<|0.72|||||||ANOVA||||
1681453|NCT01229449|3092832|Superiority||||||<|0.0001|||||||ANOVA||||
1681454|NCT01229449|3092832|Superiority||||||<|0.0001|||||||ANOVA||||
1681455|NCT01229449|3092832|Superiority||||||<|0.0001|||||||ANOVA||||
1681456|NCT01229449|3092832|Superiority||||||<|0.0001|||||||ANOVA||||
1681457|NCT01229267|3092886|Other||Risk Difference (RD)|0.2||||0.942|2-Sided|95.0|-5.1|5.5|||Normal approximation||Miettinen & Nurminen||
1681458|NCT01229267|3092887|Other||Vaccine Efficacy|0.837|||||2-Sided|95.0|0.446|0.952|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is >0.25.|
1681459|NCT01229267|3092888|Other||Vaccine Efficacy|0.735|||||2-Sided|95.0|0.498|0.86|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is >0.25.|
1681460|NCT01229267|3092889|Other||Vaccine Efficacy|0.695|||||2-Sided|95.0|0.49|0.818|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is >0.25.|
1681461|NCT01229267|3092890|Superiority||Vaccine Efficacy|0.638|||||2-Sided|95.0|0.484|0.746|||||Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).|Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% confidence interval (CI) is >0.25.|
1681462|NCT01229254|3092892|Equivalence|If the 90% confidence interval was within the pre-specified bounds of [0.66, 1.50], the hypothesis of similarity between lower weight and higher weight groups was supported.|Ratio of geometric least-squares means|0.748|||||2-Sided|90.0|0.591|0.948||||||Compared to Betrixaban 90 mg (≥80 kg)|
1681463|NCT01229228|3092893|Superiority or Other||Mean Difference (Net)|22.417|Standard Error of the Mean|2.7891|<|0.001|2-Sided|95.0|16.923|27.91|||ANCOVA||||
1681464|NCT01229150|3092907|Superiority or Other|||||||0.0209||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 2 and cycle 1 day 14.|Wilcoxon matched-pairs signed rank test|||4 patients in this group; statistically underpowered.|
1681465|NCT01229150|3092907|Superiority or Other||||||<|0.0001||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 14.|Wilcoxon matched-pairs signed rank test||||
1681466|NCT01229150|3092907|Superiority or Other||||||<|0.0007||||||P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 2.|Wilcoxon matched-pairs signed rank test||||
1681467|NCT01229150|3092909|Superiority or Other|||||||0.81|||||||Log Rank||||
1681468|NCT01229150|3092909|Superiority or Other|||||||0.51|||||||Log Rank||||
1681469|NCT01229150|3092913|Superiority or Other|||||||0.75|||||||Log Rank||||
1681470|NCT01229150|3092913|Superiority or Other|||||||0.24|||||||Log Rank||||
1681471|NCT01228903|3092929|Equivalence|(Doehner et al.) CHF patients on allopurinol (n= 14) had improved BA-FMD= 10.6 ± 2.0 (mean ± SE) vs placebo (n= 14, FMD= 6.7 ± 0.1); difference in means= 3.9. Yiginer et al. found a similar difference in metabolic syndrome. A sample size of 34/group will have 80% power to detect a difference in means of 3.9 (common standard deviation=5.6, two group t-test=0.050 two-sided significance). Accounting for a potential drop-out rate17%, n= 40/group was recruited.|Mean Difference (Net)|0.7||||0.47|2-Sided||||||Wilcoxon (Mann-Whitney)||The estimated value represents the difference between the change from baseline in both groups.|The null hypothesis was the there will be no difference between the placebo and allopurinol. The power for the study was calculated (as appropriate) based on the prior literature.|
1681472|NCT01228747|3092934|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|6.15|<|0.0001|2-Sided|95.0|0.0|0.0||Statistical testing was 2-sided, and was performed using a significance (α) level of 0.05.|ANCOVA|||"The statistical hypotheses, null hypothesis (H0) and alternate hypothesis (H1), are stated below:~H0: μLEV = μPBO vs. H1: μLEV ≠ μPBO~ANCOVA on the endpoint “percentage change from Combined Baseline of GTC seizures per week” using “treatment” and “country” as factors (categorical predictors) and “Combined Baseline GTC seizure frequency per week” as a covariate (a continuous predictor) where μLEV and μPBO are adjusted means for LEV and PBO, respectively."|
1681473|NCT01228734|3092939|Superiority or Other (legacy)||Hazard Ratio (HR)|0.629|||<|0.001|2-Sided|95.0|0.498|0.794|||Log Rank||||
1681474|NCT01228591|3092944|Non-Inferiority or Equivalence|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.021|Standard Error of the Mean|0.006|||2-Sided|95.0|0.009|0.3305|||||Mean Difference is defined to be: test lens (Advance Plus) - control lens (Advance).|"For High Luminance/ Low Contrast Grouping (Binocular):~Ho: The test lens (Advance Plus) will be non-inferior from the control lens (Advance).~Ha: The test lens (Advance Plus) will be <= to the control lens (Advance)."|
1681475|NCT01228591|3092944|Non-Inferiority or Equivalence|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.016|Standard Error of the Mean|0.0061|||2-Sided|95.0|0.0041|0.0282|||||Mean difference represents: Test lens (Advance Plus) - Control lens (Advance).|"For Low Luminance/ High Contrast Grouping (Monocular):~Ho: The test lens (Advance Plus) will be non-inferior to the control lens (Advance).~Ha: The test lens (Advance Plus) will be <= to the control lens (Advance)."|
1681476|NCT01228591|3092945|Non-Inferiority or Equivalence|Non-inferiority is assessed with a margin of -0.05 logMAR.|Mean Difference (Final Values)|0.003|Standard Error of the Mean|0.0059|||2-Sided|95.0|-0.0086|0.0146|||||The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)|"High Luminance/ Low Contrast grouping (Binocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be <= to the control lens (Acuvue Advance)."|
1681477|NCT01228591|3092945|Non-Inferiority or Equivalence|Non-inferiority is assessed with a margin of -0.05logMAR.|Mean Difference (Final Values)|0.007|Standard Error of the Mean|0.0059|||2-Sided|95.0|-0.0044|0.0187|||||The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)|"For Low Luminance/ High Contrast grouping (Monocular):~Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance).~Ha: The test lens (Acuvue Advance Plus) will be <= to the control lens (Acuvue Advance)."|
1681478|NCT01227967|3093031|Superiority or Other||Mean Difference (Final Values)|-10.0|Standard Error of the Mean|5.0||0.046|2-Sided|95.0|-19.8|-0.2||P-value was not adjusted for multiple interim analyses.|Z-test, 2-sided|Comparison of randomized arms was based on the normal approximation to the binomial distribution.|The difference in percents was calculated as the percent detectable in the Combination Therapy minus the percent detectable in the Oseltamivir Monotherapy.|Assuming that pooled percentage of participants with virus detectable by PCR at Day 3 is 50%, assuming that the Combination Therapy was better than the Oseltamivir Monotherapy and that the detectable rate in the Combination Therapy was 42.5% compared to 57.5% in the Oseltamivir Monotherapy (a 15% reduction), and assuming 10% subjects with missing qPCR at Day 3, in a two-sided, two-sample 0.05-level t- test with 546 participants combined across both arms, there was 90% power.|
1681479|NCT01227954|3093036|Superiority|||||||0.0749|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (>= 60 vs. <60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p< 0.10, except time forced in the model.). Age (>= 60) is reported here.|
1681480|NCT01227954|3093036|Superiority|||||||0.0559|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (>= 60 vs. <60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p< 0.10, except time forced in the model.). Neurologic function status (some symptoms) is reported here.|
1681481|NCT01227954|3093036|Superiority|||||||0.1579|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (>= 60 vs. <60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p< 0.10, except time forced in the model.). Time is reported here.|
1681482|NCT01227954|3093036|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with ADL (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (>= 60 vs. <60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p< 0.10, except time forced in the model.). Intercept is reported here.|
1681483|NCT01227954|3093037|Superiority|||||||0.0554|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (>= 60 vs. <60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p< 0.10, except time forced in the model.). Neurologic status (no symptoms) is reported here.|
1681484|NCT01227954|3093037|Superiority|||||||0.0715|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (>= 60 vs. <60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p< 0.10, except time forced in the model.). Primary site (lung) is reported here.|
1681485|NCT01227954|3093037|Superiority|||||||0.1961|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables in the model: Age (>= 60 vs. <60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and RPA class(I vs. II). Explanatory variables are reported separately and only if they are in the final model (p< 0.10, except time forced in the model.). Time is reported here.|
1681486|NCT01227954|3093037|Superiority||||||<|0.0001|||||||Mixed Models Analysis|Each explanatory variable in the final model is reported separately.||A general linear fixed effects model was run with FACT-Br total score (baseline, 2, 4, 6 mo. from end of treatment) as outcome of interest. Explanatory variables: Age (>= 60 vs. <60), primary site (lung,breast,colon each vs. other), neurologic function status (no vs. some symptoms), and recursive partitioning analysis class (RPA) (I vs. II). Explanatory variables are reported separately and only if in the final model (p< 0.10, except time forced in the model.). Intercept is reported here.|
1681487|NCT01227954|3093040|Superiority||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||To detect a minimum relative 50% improvement leading to an absolute 15% mean relative decline (MRD) in HVLT-R DR, 51 analyzable patients were required to ensure 80% statistical power with 0.05 alpha. Assuming a death rate of 40% before 4 months (based on trial NCT00003563) and a 10% nonevaluable rate, the target sample size was 102. The target MRD was determined from NCT00003563 which demonstrated 30% MRD in HVLT-R DR score from baseline to 4 months, with a standard deviation of 41%.|
1681488|NCT01227928|3093054|Superiority or Other||Hazard Ratio (HR)|0.811||||0.5901|2-Sided|95.0|0.376|1.751|||Log Rank||The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the three stratification factors.||
1681489|NCT01227928|3093055|Superiority or Other||Hazard Ratio (HR)|0.984|||||2-Sided|95.0|0.595|1.626|||||The Hazard Ratio (HR) is estimated using a Pike estimator. The HR was adjusted for the stratification factor of first-line treatment outcome.||
1681490|NCT01227902|3093072|Superiority or Other||percentage of participants|44.5|||||2-Sided|95.0|37.6|51.4|||||The estimated value represents the percentage of participants with a >=50% reduction in partial-onset seizure frequency from Baseline.||
1681491|NCT01227902|3093072|Superiority or Other||percentage of participants|56.9|||||2-Sided|95.0|43.3|70.5|||||The estimated value represents the percentage of participants with a >=50% reduction in partial-onset seizure frequency from Baseline.||
1681492|NCT01227902|3093072|Superiority or Other||percentage of participants|50.0|||||2-Sided|95.0|35.2|64.8|||||The estimated value represents the percentage of participants with a >=50% reduction in partial-onset seizure frequency from Baseline.||
1681493|NCT01227902|3093072|Superiority or Other||percentage of participants|32.0|||||2-Sided|95.0|19.1|44.9|||||The estimated value represents the percentage of participants with a >=50% reduction in partial-onset seizure frequency from Baseline.||
1681494|NCT01227902|3093072|Superiority or Other||percentage of participants|40.0|||||2-Sided|95.0|27.1|52.9|||||The estimated value represents the percentage of participants with a >=50% reduction in partial-onset seizure frequency from Baseline.||
1681495|NCT01227889|3093082|Other||Hazard Ratio (HR)|0.82|||||2-Sided|95.0|0.57|1.18|||||HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.||
1681496|NCT01227889|3093083|Superiority or Other||Hazard Ratio (HR)|0.35|||||2-Sided|95.0|0.2|0.61|||||HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.||
1681497|NCT01227889|3093084|Superiority or Other||Hazard Ratio (HR)|0.4|||<|0.0001|2-Sided|95.0|0.26|0.6||The p value from a stratified log-rank test was adjusted for disease stage at screening.|Log Rank||HRs were estimated using a Pike estimator. HR from a stratified log-rank test was adjusted for disease stage at screening.||
1681498|NCT01227824|3093096|Non-Inferiority or Equivalence|Non-inferiority could be concluded if the lower bound of a two-sided 95% confidence interval for the difference (DTG - RAL) in percentages between the two treatment arms was > -10%.|Difference in percentage|2.5|||||2-Sided|95.0|-2.2|7.1|||||Analysis was based on Cochran-Mantel Haenszel stratified analysis adjusted for the following Baseline stratification factors: baseline HIV-1 RNA and background dual NRTI.||
1681499|NCT01227707|3093146|Superiority or Other|||||||1|||||||one sample binomial test||||
1681500|NCT01227681|3093147|Superiority or Other|||||||0.64|||||||t-test, 2 sided|||Null hypothesis: there is significant deterioration of UPDRS part III scores from baseline to post G-CSF injection one year|
1681501|NCT01227668|3093150|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.09|2-Sided|95.0|-1.3|0.1||Treatment diff in chg from BL to endpnt in IS score was tested at 0.05 signif only if ARP arm signif differed vs pb from PA. Thus, if ARP arm signif differed vs pb in IS score, treatment diff in mean CGI-I score at endpnt was tested at 0.05 signfnce.|ANCOVA||||
1681502|NCT01227668|3093151|Superiority or Other||Mean Difference (Final Values)|-4.4||||0.051|2-Sided|95.0|-8.82|0.02||For secondary endpoints, hierarchical testing aimed to keep the overall experiment-wise type I error rate to <=0.05. Difference in chg from BL was tested at 0.05 significance only if APR arm significantly differed vs placebo from primary analysis.|ANCOVA||||
1681503|NCT01227668|3093152|Superiority or Other||Hazard Ratio (HR)|0.57||||0.097|2-Sided|95.0|0.28|1.12|||Stratified log rank||||
1681504|NCT01227629|3093166|Superiority or Other|||||||0.26711|||||||Kruskal-Wallis|||Group comparison of differences from baseline to week 12|
1681505|NCT01227629|3093167|Superiority or Other|||||||0.0357|||||||Kruskal-Wallis|||Group comparison of differences from baseline to last available value|
1681506|NCT01227616|3093180|Non-Inferiority|The study protocol defined the margin for non-inferiority as 0.5 g/dL meaning non–inferiority would be established in a TP if the lower limit of the 95% confidence limit for the difference between ferumoxytol and iron sucrose mean change was ≥0.5 g/dL.|Mean Difference (Final Values)|0.5|||<|0.05|2-Sided||||||ANCOVA|Stats. of primary endpoint performed only for TP1 and TP2. 240 subjects retreated should yield 90% power to detect non-inferiority during TP2.|||
1681507|NCT01227564|3093204|Superiority or Other||Mean Difference (Final Values)|-8.07||||0.3452|2-Sided|95.0|-25.05|8.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681732|NCT01227265|3093282|Superiority or Other||Difference in Estimated Means|0.2||||0.6142|2-Sided|95.0|-0.57|0.97|||cLDA||||
1681733|NCT01227265|3093282|Superiority or Other||Difference in Estimated Means|-0.2||||0.6968|2-Sided|95.0|-0.92|0.61|||cLDA||||
1681508|NCT01227564|3093204|Superiority or Other||Mean Difference (Final Values)|-7.51||||0.3728|2-Sided|95.0|-24.25|9.23||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681509|NCT01227564|3093204|Superiority or Other||Mean Difference (Final Values)|0.74||||0.422|2-Sided|95.0|-1.09|2.56||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681510|NCT01227564|3093204|Superiority or Other||Mean Difference (Final Values)|0.8||||0.3693|2-Sided|95.0|-0.97|2.58||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681511|NCT01227564|3093204|Superiority or Other||Mean Difference (Final Values)|3.02||||0.2328|2-Sided|95.0|-1.99|8.04||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681512|NCT01227564|3093204|Superiority or Other||Mean Difference (Final Values)|0.72||||0.771|2-Sided|95.0|-4.18|5.61||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681513|NCT01227564|3093204|Superiority or Other||Mean Difference (Final Values)|2.48||||0.4613|2-Sided|95.0|-4.2|9.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681514|NCT01227564|3093204|Superiority or Other||Mean Difference (Final Values)|-1.42||||0.6653|2-Sided|95.0|-7.94|5.1||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681515|NCT01227564|3093205|Superiority or Other||Mean Difference (Final Values)|-26.2||||0.0973|2-Sided|95.0|-57.42|5.03||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681516|NCT01227564|3093205|Superiority or Other||Mean Difference (Final Values)|16.04||||0.2969|2-Sided|95.0|-14.7|46.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681517|NCT01227564|3093205|Superiority or Other||Mean Difference (Final Values)|-64.97||||0.049|2-Sided|95.0|-129.64|-0.31||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681734|NCT01227265|3093286|Superiority or Other||Difference in Estimated Means|0.1||||0.683|2-Sided|95.0|-0.44|0.67|||cLDA||||
1681518|NCT01227564|3093205|Superiority or Other||Mean Difference (Final Values)|-30.94||||0.3196|2-Sided|95.0|-92.67|30.78||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681519|NCT01227564|3093205|Superiority or Other||Mean Difference (Final Values)|-29.7||||0.017|2-Sided|95.0|-53.89|-5.5||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681520|NCT01227564|3093205|Superiority or Other||Mean Difference (Final Values)|-4.96||||0.6724|2-Sided|95.0|-28.34|18.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681521|NCT01227564|3093205|Superiority or Other||Mean Difference (Final Values)|-12.51||||0.1266|2-Sided|95.0|-28.86|3.65||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681522|NCT01227564|3093205|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.7537|2-Sided|95.0|-18.36|13.36||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681523|NCT01227564|3093207|Superiority or Other||Median Difference (Final Values)|-0.52||||0.6582|2-Sided|95.0|-2.86|1.82||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.|
1681524|NCT01227564|3093207|Superiority or Other||Mean Difference (Final Values)|-1.28||||0.346|2-Sided|95.0|-3.98|1.42||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.|
1681525|NCT01227564|3093207|Superiority or Other||Mean Difference (Final Values)|0.24||||0.8566|2-Sided|95.0|-2.43|2.92||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 86.|
1681526|NCT01227564|3093207|Superiority or Other||Mean Difference (Final Values)|-1.08||||0.3969|2-Sided|95.0|-3.62|1.46||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.|
1681527|NCT01227564|3093207|Superiority or Other||Mean Difference (Final Values)|-1.64||||0.2733|2-Sided|95.0|-4.6|1.33||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.|
1681735|NCT01227265|3093286|Superiority or Other||Difference in Estimated Means|0.1||||0.776|2-Sided|95.0|-0.47|0.63|||cLDA||||
1681528|NCT01227564|3093207|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.7146|2-Sided|95.0|-3.4|2.35||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 54.|
1681529|NCT01227564|3093208|Superiority or Other||Mean Difference (Final Values)|0.08||||0.9478|2-Sided|95.0|-2.41|2.58||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681530|NCT01227564|3093208|Superiority or Other||Mean Difference (Final Values)|1.19||||0.4128|2-Sided|95.0|-1.7|4.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681531|NCT01227564|3093208|Superiority or Other||Mean Difference (Final Values)|-1.02||||0.4709|2-Sided|95.0|-3.85|1.81||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681532|NCT01227564|3093208|Superiority or Other||Mean Difference (Final Values)|-0.68||||0.4674|2-Sided|95.0|-2.54|1.18||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681533|NCT01227564|3093208|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.6494|2-Sided|95.0|-2.67|1.68||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681534|NCT01227564|3093208|Superiority or Other||Mean Difference (Final Values)|-0.86||||0.4177|2-Sided|95.0|-2.98|1.25||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681535|NCT01227564|3093208|Superiority or Other||Median Difference (Final Values)|-0.7||||0.3764|2-Sided|95.0|-2.27|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681536|NCT01227564|3093208|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.7988|2-Sided|95.0|-2.07|1.6||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681537|NCT01227564|3093208|Superiority or Other||Mean Difference (Final Values)|-1.16||||0.2008|2-Sided|95.0|-2.96|0.64||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681763|NCT01226706|3093357|Superiority or Other|||||||0.038|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681538|NCT01227564|3093208|Superiority or Other||Mean Difference (Final Values)|0.03||||0.9682|2-Sided|95.0|-1.39|1.44||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681539|NCT01227564|3093208|Superiority or Other||Mean Difference (Final Values)|0.01||||0.9914|2-Sided|95.0|-1.63|1.65||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681540|NCT01227564|3093208|Superiority or Other||Mean Difference (Final Values)|0.05||||0.9535|2-Sided|95.0|-1.58|1.68||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681541|NCT01227564|3093209|Superiority or Other||Mean Difference (Final Values)|0.47||||0.6723|2-Sided|95.0|-1.77|2.71||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681542|NCT01227564|3093209|Superiority or Other||Mean Difference (Final Values)|0.49||||0.7004|2-Sided|95.0|-2.06|3.03||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681543|NCT01227564|3093209|Superiority or Other||Mean Difference (Final Values)|0.46||||0.7184|2-Sided|95.0|-2.09|3.0||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681544|NCT01227564|3093209|Superiority or Other||Mean Difference (Final Values)|-1.61||||0.0716|2-Sided|95.0|-3.37|0.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681545|NCT01227564|3093209|Superiority or Other||Mean Difference (Final Values)|-2.11||||0.0427|2-Sided|95.0|-4.15|-0.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681546|NCT01227564|3093209|Superiority or Other||Mean Difference (Final Values)|-1.11||||0.2672|2-Sided|95.0|-3.09|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681547|NCT01227564|3093209|Superiority or Other||Median Difference (Final Values)|-0.88||||0.3082|2-Sided|95.0|-2.61|0.84||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681764|NCT01226706|3093358|Superiority or Other|||||||0.095|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681548|NCT01227564|3093209|Superiority or Other||Mean Difference (Final Values)|-1.03||||0.3061|2-Sided|95.0|-3.04|0.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681549|NCT01227564|3093209|Superiority or Other||Mean Difference (Final Values)|-0.73||||0.4542|2-Sided|95.0|-2.69|1.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681550|NCT01227564|3093209|Superiority or Other||Mean Difference (Final Values)|-0.62||||0.4852|2-Sided|95.0|-2.38|1.14||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681551|NCT01227564|3093209|Superiority or Other||Mean Difference (Final Values)|-1.16||||0.2597|2-Sided|95.0|-3.19|0.88||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681552|NCT01227564|3093209|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.937|2-Sided|95.0|-2.09|1.93||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681553|NCT01227564|3093210|Superiority or Other||Mean Difference (Final Values)|-0.74||||0.5541|2-Sided|95.0|-3.23|1.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681554|NCT01227564|3093210|Superiority or Other||Mean Difference (Final Values)|-0.77||||0.5853|2-Sided|95.0|-3.6|2.06||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681555|NCT01227564|3093210|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.6186|2-Sided|95.0|-3.52|2.12||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681556|NCT01227564|3093210|Superiority or Other||Mean Difference (Final Values)|-1.75||||0.2234|2-Sided|95.0|-4.58|1.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681557|NCT01227564|3093210|Superiority or Other||Mean Difference (Final Values)|-2.17||||0.1964|2-Sided|95.0|-5.49|1.15||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681765|NCT01226706|3093359|Superiority or Other|||||||0.038|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681558|NCT01227564|3093210|Superiority or Other||Mean Difference (Final Values)|-1.32||||0.4089|2-Sided|95.0|-4.51|1.86||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681559|NCT01227564|3093210|Superiority or Other||Median Difference (Final Values)|-0.45||||0.76|2-Sided|95.0|-3.36|2.47||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681560|NCT01227564|3093210|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.9028|2-Sided|95.0|-3.62|3.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681561|NCT01227564|3093210|Superiority or Other||Mean Difference (Final Values)|-0.68||||0.679|2-Sided|95.0|-3.98|2.61||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681562|NCT01227564|3093210|Superiority or Other||Mean Difference (Final Values)|-3.13||||0.0176|2-Sided|95.0|-5.69|-0.57||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681563|NCT01227564|3093210|Superiority or Other||Mean Difference (Final Values)|-4.26||||0.0057|2-Sided|95.0|-7.23|-1.29||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681564|NCT01227564|3093210|Superiority or Other||Mean Difference (Final Values)|-1.99||||0.1767|2-Sided|95.0|-4.9|0.92||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681565|NCT01227564|3093211|Superiority or Other||Mean Difference (Final Values)|0.57||||0.284|2-Sided|95.0|-0.49|1.64||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681566|NCT01227564|3093211|Superiority or Other||Mean Difference (Final Values)|0.12||||0.8482|2-Sided|95.0|-1.11|1.35||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681567|NCT01227564|3093211|Superiority or Other||Mean Difference (Final Values)|1.03||||0.0923|2-Sided|95.0|-0.18|2.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681766|NCT01226706|3093363|Superiority or Other|||||||0.067|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681568|NCT01227564|3093211|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.914|2-Sided|95.0|-0.92|0.82||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681569|NCT01227564|3093211|Superiority or Other||Mean Difference (Final Values)|-0.56||||0.274|2-Sided|95.0|-1.58|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681570|NCT01227564|3093211|Superiority or Other||Mean Difference (Final Values)|0.47||||0.345|2-Sided|95.0|-0.51|1.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681571|NCT01227564|3093211|Superiority or Other||Median Difference (Final Values)|0.04||||0.9227|2-Sided|95.0|-0.68|0.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681572|NCT01227564|3093211|Superiority or Other||Mean Difference (Final Values)|-0.32||||0.4501|2-Sided|95.0|-1.16|0.52||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681573|NCT01227564|3093211|Superiority or Other||Mean Difference (Final Values)|0.39||||0.3425|2-Sided|95.0|-0.43|1.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681574|NCT01227564|3093211|Superiority or Other||Mean Difference (Final Values)|0.25||||0.3347|2-Sided|95.0|-0.26|0.75||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681575|NCT01227564|3093211|Superiority or Other||Mean Difference (Final Values)|0.1||||0.7281|2-Sided|95.0|-0.49|0.69||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681576|NCT01227564|3093211|Superiority or Other||Mean Difference (Final Values)|0.39||||0.1796|2-Sided|95.0|-0.18|0.96||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681577|NCT01227564|3093212|Superiority or Other||Mean Difference (Final Values)|0.35||||0.8454|2-Sided|95.0|-3.21|3.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681767|NCT01226706|3093364|Superiority or Other|||||||0.095|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681578|NCT01227564|3093212|Superiority or Other||Mean Difference (Final Values)|-1.55||||0.4499|2-Sided|95.0|-5.64|2.55||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681579|NCT01227564|3093212|Superiority or Other||Mean Difference (Final Values)|2.24||||0.2622|2-Sided|95.0|-1.74|6.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681580|NCT01227564|3093212|Superiority or Other||Mean Difference (Final Values)|-1.16||||0.4618|2-Sided|95.0|-4.29|1.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681581|NCT01227564|3093212|Superiority or Other||Mean Difference (Final Values)|-2.79||||0.1323|2-Sided|95.0|-6.45|0.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681582|NCT01227564|3093212|Superiority or Other||Mean Difference (Final Values)|0.47||||0.7857|2-Sided|95.0|-3.0|3.95||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681583|NCT01227564|3093212|Superiority or Other||Median Difference (Final Values)|-0.05||||0.9704|2-Sided|95.0|-2.61|2.51||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681584|NCT01227564|3093212|Superiority or Other||Mean Difference (Final Values)|-1.87||||0.2151|2-Sided|95.0|-4.87|1.12||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681585|NCT01227564|3093212|Superiority or Other||Mean Difference (Final Values)|1.78||||0.2143|2-Sided|95.0|-1.06|4.62||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681586|NCT01227564|3093212|Superiority or Other||Mean Difference (Final Values)|0.05||||0.9616|2-Sided|95.0|-2.06|2.16||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681587|NCT01227564|3093212|Superiority or Other||Mean Difference (Final Values)|-1.55||||0.213|2-Sided|95.0|-4.01|0.91||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681768|NCT01226706|3093365|Superiority or Other|||||||0.152|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681588|NCT01227564|3093212|Superiority or Other||Mean Difference (Final Values)|1.65||||0.1597|2-Sided|95.0|-0.67|3.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681589|NCT01227564|3093213|Superiority or Other||Mean Difference (Final Values)|0.18||||0.3302|2-Sided|95.0|-0.19|0.55||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681590|NCT01227564|3093213|Superiority or Other||Mean Difference (Final Values)|0.33||||0.1233|2-Sided|95.0|-0.09|0.76||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681591|NCT01227564|3093213|Superiority or Other||Mean Difference (Final Values)|0.03||||0.8918|2-Sided|95.0|-0.39|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681592|NCT01227564|3093213|Superiority or Other||Mean Difference (Final Values)|0.12||||0.3878|2-Sided|95.0|-0.15|0.39||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681593|NCT01227564|3093213|Superiority or Other||Mean Difference (Final Values)|0.28||||0.0857|2-Sided|95.0|-0.04|0.6||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681594|NCT01227564|3093213|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.7843|2-Sided|95.0|-0.35|0.26||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681595|NCT01227564|3093213|Superiority or Other||Median Difference (Final Values)|-0.02||||0.8628|2-Sided|95.0|-0.24|0.2||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681596|NCT01227564|3093213|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.8791|2-Sided|95.0|-0.28|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681597|NCT01227564|3093213|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.8825|2-Sided|95.0|-0.27|0.23||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681801|NCT01225822|3093479|Superiority or Other||Odds Ratio (OR)|0.121||||0.0472||95.0|0.015|0.974|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint|
1681598|NCT01227564|3093213|Superiority or Other||Mean Difference (Final Values)|0.01||||0.9452|2-Sided|95.0|-0.17|0.18||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681599|NCT01227564|3093213|Superiority or Other||Mean Difference (Final Values)|0.04||||0.6804|2-Sided|95.0|-0.16|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681600|NCT01227564|3093213|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.7687|2-Sided|95.0|-0.23|0.17||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681601|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|0.032||||0.5044|2-Sided|95.0|-0.063|0.127||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681602|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|0.07||||0.2082|2-Sided|95.0|-0.04|0.181||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681603|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|-0.006||||0.9037|2-Sided|95.0|-0.113|0.1||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681604|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|0.013||||0.7454|2-Sided|95.0|-0.065|0.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681605|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|0.042||||0.36|2-Sided|95.0|-0.049|0.132||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681606|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|-0.016||||0.7067|2-Sided|95.0|-0.104|0.071||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681607|NCT01227564|3093214|Superiority or Other||Median Difference (Final Values)|0.013||||0.5734|2-Sided|95.0|-0.033|0.058||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681864|NCT01225055|3093560|Superiority|||||||0.01||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA|||
1681608|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|0.04||||0.1336|2-Sided|95.0|-0.013|0.093||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681609|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|-0.015||||0.5742|2-Sided|95.0|-0.066|0.037||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681610|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|0.012||||0.4057|2-Sided|95.0|-0.017|0.041||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681611|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|0.032||||0.064|2-Sided|95.0|-0.002|0.066||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681612|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|-0.008||||0.6446|2-Sided|95.0|-0.041|0.026||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681613|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|0.005||||0.7311|2-Sided|95.0|-0.024|0.035||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681614|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|0.016||||0.3517|2-Sided|95.0|-0.018|0.051||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681615|NCT01227564|3093214|Superiority or Other||Mean Difference (Final Values)|-0.006||||0.7259|2-Sided|95.0|-0.04|0.028||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline right hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681616|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|0.04||||0.3732|2-Sided|95.0|-0.049|0.129||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681617|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|0.072||||0.1707|2-Sided|95.0|-0.032|0.176||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681925|NCT01222520|3093756|Superiority or Other||Least square mean difference|14.88|||<|0.0001||95.0|11.82|17.94|||ANCOVA||||
1681618|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|0.008||||0.8697|2-Sided|95.0|-0.092|0.108||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681619|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|0.016||||0.6246|2-Sided|95.0|-0.049|0.082||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681620|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|0.039||||0.3116|2-Sided|95.0|-0.038|0.116||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681621|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|-0.007||||0.8532|2-Sided|95.0|-0.08|0.067||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681622|NCT01227564|3093215|Superiority or Other||Median Difference (Final Values)|0.008||||0.7224|2-Sided|95.0|-0.035|0.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681623|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|0.027||||0.2807|2-Sided|95.0|-0.023|0.076||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681624|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|-0.012||||0.6259|2-Sided|95.0|-0.06|0.036||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681625|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|-0.008||||0.6072|2-Sided|95.0|-0.037|0.022||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681626|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|0.003||||0.8817|2-Sided|95.0|-0.031|0.037||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681627|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|-0.018||||0.295|2-Sided|95.0|-0.051|0.016||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681926|NCT01222520|3093757|Superiority or Other||Least square mean difference|9.14|||<|0.0001||95.0|7.09|11.18|||ANCOVA||||
1681628|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|-0.001||||0.9401|2-Sided|95.0|-0.029|0.027||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681629|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|0.008||||0.6083|2-Sided|95.0|-0.024|0.041||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681630|NCT01227564|3093215|Superiority or Other||Mean Difference (Final Values)|-0.011||||0.5134|2-Sided|95.0|-0.043|0.022||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline left hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681631|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|0.073||||0.4145|2-Sided|95.0|-0.105|0.25||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681632|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|0.143||||0.1715|2-Sided|95.0|-0.064|0.349||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681633|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|0.003||||0.9752|2-Sided|95.0|-0.196|0.202||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681634|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|0.028||||0.6872|2-Sided|95.0|-0.11|0.166||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681635|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|0.079||||0.3309|2-Sided|95.0|-0.082|0.24||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681636|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|-0.023||||0.7658|2-Sided|95.0|-0.177|0.131||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681637|NCT01227564|3093216|Superiority or Other||Median Difference (Final Values)|0.02||||0.6255|2-Sided|95.0|-0.063|0.103||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681865|NCT01225055|3093561|Superiority|||||||0.04||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA|||
1681638|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|0.067||||0.174|2-Sided|95.0|-0.03|0.163||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681639|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|-0.026||||0.5847|2-Sided|95.0|-0.12|0.068||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681640|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|0.005||||0.8549|2-Sided|95.0|-0.048|0.058||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681641|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|0.034||||0.273|2-Sided|95.0|-0.028|0.097||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681642|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|-0.025||||0.4216|2-Sided|95.0|-0.085|0.036||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681643|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|0.005||||0.8518|2-Sided|95.0|-0.046|0.056||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681644|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|0.025||||0.4087|2-Sided|95.0|-0.035|0.084||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681645|NCT01227564|3093216|Superiority or Other||Mean Difference (Final Values)|-0.015||||0.6054|2-Sided|95.0|-0.074|0.043||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline hippocampal volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681646|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|-0.074||||0.9513|2-Sided|95.0|-2.485|2.337||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681647|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.5706|2-Sided|95.0|-3.606|2.007||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681802|NCT01225822|3093479|Superiority or Other||Odds Ratio (OR)|1.136||||0.7192||95.0|0.567|2.276|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as for primary endpoint|
1681648|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|0.652||||0.6325|2-Sided|95.0|-2.063|3.367||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681649|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|-0.387||||0.6772|2-Sided|95.0|-2.239|1.464||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681650|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|-1.029||||0.3444|2-Sided|95.0|-3.189|1.131||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681651|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|0.255||||0.8074|2-Sided|95.0|-1.827|2.337||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681652|NCT01227564|3093217|Superiority or Other||Median Difference (Final Values)|-0.405||||0.4491|2-Sided|95.0|-1.469|0.659||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681653|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|-0.796||||0.2034|2-Sided|95.0|-2.034|0.443||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681654|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|-0.014||||0.981|2-Sided|95.0|-1.221|1.192||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681655|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|-0.149||||0.6204|2-Sided|95.0|-0.748|0.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681656|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|-0.304||||0.3845|2-Sided|95.0|-1.0|0.392||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681657|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|0.007||||0.9846|2-Sided|95.0|-0.675|0.688||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681803|NCT01225822|3093479|Superiority or Other||Odds Ratio (OR)|16.907||||0.0062||95.0|2.229|128.238|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as for primary endpoint|
1681658|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|0.282||||0.2907|2-Sided|95.0|-0.247|0.812||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681659|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|0.147||||0.6331|2-Sided|95.0|-0.465|0.759||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681660|NCT01227564|3093217|Superiority or Other||Mean Difference (Final Values)|0.418||||0.1695|2-Sided|95.0|-0.183|1.018||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline ventricular volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681661|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|1.95||||0.6205|2-Sided|95.0|-5.888|9.878||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681662|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|6.11||||0.1844|2-Sided|95.0|-2.993|15.212||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681663|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|-2.21||||0.6167|2-Sided|95.0|-10.999|6.579||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681664|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|2.506||||0.4371|2-Sided|95.0|-3.904|8.915||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681665|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|5.394||||0.1533|2-Sided|95.0|-2.069|12.857||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681666|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|-0.383||||0.9151|2-Sided|95.0|-7.549|6.783||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 76.|
1681667|NCT01227564|3093218|Superiority or Other||Median Difference (Final Values)|5.394||||0.4909|2-Sided|95.0|-2.937|6.049||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681866|NCT01225055|3093561|Superiority|||||||0.1||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA|||
1681668|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|4.758||||0.074|2-Sided|95.0|-0.476|9.991||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681669|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|-1.645||||0.519|2-Sided|95.0|-6.721|3.43||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 50.|
1681670|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|1.687||||0.3163|2-Sided|95.0|-1.656|5.031||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681671|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|3.549||||0.0743|2-Sided|95.0|-0.36|7.458||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681672|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|-0.174||||0.9274|2-Sided|95.0|-3.99|3.641||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 24.|
1681673|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|-1.078||||0.5331|2-Sided|95.0|-4.519|2.364||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681674|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|0.497||||0.8051|2-Sided|95.0|-3.515|4.508||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681675|NCT01227564|3093218|Superiority or Other||Mean Difference (Final Values)|-2.652||||0.1807|2-Sided|95.0|-6.57|1.267||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with baseline total brain volume and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 10.|
1681676|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|173.16||||0.0161|2-Sided|95.0|33.25|313.07||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681677|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|204.4||||0.0151|2-Sided|95.0|41.02|367.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681867|NCT01225055|3093561|Superiority|||||||0.02||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA|||
1681678|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|141.92||||0.0747|2-Sided|95.0|-14.62|298.45||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 104.|
1681679|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|167.33||||0.0387|2-Sided|95.0|9.03|325.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681680|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|226.82||||0.0181|2-Sided|95.0|40.23|413.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681681|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|107.84||||0.2277|2-Sided|95.0|-69.29|284.97||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 78.|
1681682|NCT01227564|3093219|Superiority or Other||Median Difference (Final Values)|167.33||||0.0387|2-Sided|95.0|9.03|325.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681683|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|226.82||||0.0181|2-Sided|95.0|40.23|413.41||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681684|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|114.13||||0.0766|2-Sided|95.0|-12.63|240.89||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 52.|
1681685|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|162.46||||0.0204|2-Sided|95.0|26.05|298.87||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681686|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|225.63||||0.0067|2-Sided|95.0|65.18|386.09||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681687|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|99.29||||0.2006|2-Sided|95.0|-54.28|252.86||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 26.|
1681922|NCT01222520|3093753|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1681688|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|35.42||||0.1638|2-Sided|95.0|-14.88|85.72||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.|
1681689|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|51.06||||0.0915|2-Sided|95.0|-8.51|110.63||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.|
1681690|NCT01227564|3093219|Superiority or Other||Mean Difference (Final Values)|19.78||||0.4892|2-Sided|95.0|-37.15|76.71||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed effects model for repeated measures analysis was used, with the baseline assessment and ApoE4 status as covariates, and visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. Statistical analysis presented above for Week 12.|
1681691|NCT01227564|3093220|Superiority or Other||Mean Difference (Final Values)|-56.88||||0.0801|2-Sided|95.0|-120.82|7.06||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.|
1681692|NCT01227564|3093220|Superiority or Other||Mean Difference (Final Values)|-83.4||||0.0327|2-Sided|95.0|-159.69|-7.11||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.|
1681693|NCT01227564|3093220|Superiority or Other||Mean Difference (Final Values)|-30.36||||0.4089|2-Sided|95.0|-103.52|42.81||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.|
1681694|NCT01227564|3093221|Superiority or Other||Mean Difference (Final Values)|-3.93||||0.1742|2-Sided|95.0|-9.66|1.79||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.|
1681695|NCT01227564|3093221|Superiority or Other||Mean Difference (Final Values)|-4.51||||0.1876|2-Sided|95.0|-11.28|2.27||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.|
1681696|NCT01227564|3093221|Superiority or Other||Mean Difference (Final Values)|-3.36||||0.3106|2-Sided|95.0|-9.94|3.22||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.|
1681697|NCT01227564|3093222|Superiority or Other||Mean Difference (Final Values)|54.29||||0.1672|2-Sided|95.0|-23.47|132.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.|
1681698|NCT01227564|3093222|Superiority or Other||Mean Difference (Final Values)|84.42||||0.0648|2-Sided|95.0|-5.37|174.21||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.|
1681699|NCT01227564|3093222|Superiority or Other||Mean Difference (Final Values)|24.16||||0.5818|2-Sided|95.0|-63.31|111.62||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.|
1681700|NCT01227564|3093223|Superiority or Other||Mean Difference (Final Values)|315.08||||0.5773|2-Sided|95.0|-812.15|1442.3||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.|
1681701|NCT01227564|3093223|Superiority or Other||Mean Difference (Final Values)|581.98||||0.3945|2-Sided|95.0|-778.17|1942.13||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.|
1681702|NCT01227564|3093223|Superiority or Other||Mean Difference (Final Values)|48.18||||0.9384|2-Sided|95.0|-1197.07|1293.42||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|ANCOVA|||Analysis of Covariance (ANCOVA) was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.|
1681703|NCT01227564|3093224|Superiority or Other||Median Difference (Final Values)|-0.05||||0.3221|2-Sided|95.0|-0.149|0.05||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.|
1681704|NCT01227564|3093224|Superiority or Other||Mean Difference (Final Values)|-0.049||||0.3912|2-Sided|95.0|-0.164|0.065||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.|
1681705|NCT01227564|3093224|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.3826|2-Sided|95.0|-0.164|0.064||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 104.|
1681706|NCT01227564|3093224|Superiority or Other||Mean Difference (Final Values)|-0.002||||0.9595|2-Sided|95.0|-0.099|0.095||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.|
1681707|NCT01227564|3093224|Superiority or Other||Mean Difference (Final Values)|-0.008||||0.8874|2-Sided|95.0|-0.121|0.105||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.|
1681708|NCT01227564|3093224|Superiority or Other||Mean Difference (Final Values)|0.003||||0.955|2-Sided|95.0|-0.106|0.112||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 78.|
1681709|NCT01227564|3093224|Superiority or Other||Mean Difference (Final Values)|0.002||||0.9544|2-Sided|95.0|-0.062|0.066||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg or ACC 10 µg + QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.|
1681736|NCT01227265|3093287|Superiority or Other||Estimated Difference in Percentage|6.5||||0.262|2-Sided|95.0|-4.63|17.61||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline average OFF time (hours/day) as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|Mixed Models Analysis||||
1681804|NCT01225822|3093479|Superiority or Other||Odds Ratio (OR)|15.818||||0.0077||95.0|2.077|120.474|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as for primary endpoint|
1681923|NCT01222520|3093754|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1681710|NCT01227564|3093224|Superiority or Other||Mean Difference (Final Values)|0.006||||0.8787|2-Sided|95.0|-0.07|0.081||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|Kenward-Roger was used to estimate the denominator degrees of freedom.||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 10 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.|
1681711|NCT01227564|3093224|Superiority or Other||Mean Difference (Final Values)|-0.002||||0.9538|2-Sided|95.0|-0.075|0.071||Analysis was two-sided and performed at the 0.05 significance level. No multiplicity adjustments due to multiple endpoints or multiple assessments were applied. Nominal p-values were reported in the analysis.|Mixed-Effects Model Repeated Measures|||A mixed-effect model repeated measures was used, with the baseline measure of average SUVRs over ROIs and Apo E4 Status (Carrier or Non-carrier) as covariates, time, treatment, and treatment*time as fixed effects. Estimates of the adjusted mean differences (test-reference) and corresponding 95% confidence intervals were obtained from the model. ACC 3 µg+QS-21 50 µg was the test treatment and placebo was the reference treatment. Statistical analysis presented above for Week 52.|
1681712|NCT01227512|3093227|Superiority or Other||Relative Risk|0.33||||0.1568||95.0|0.07|1.65||p-value was derived using a CMH test stratified by hyponatremia symptoms severity.|Cochran-Mantel-Haenszel||||
1681713|NCT01227512|3093228|Superiority or Other||Relative Risk|1.1||||0.5795||95.0|0.79|1.52||P-value was derived using a CMH test stratified by hyponatremia symptoms severity.|Cochran-Mantel-Haenszel||||
1681714|NCT01227512|3093229|Superiority or Other|||||||0.5128||||||p-value was derived from Generalized Wilcoxon test stratified by treatment. Participants who received rescue therapy were censored at the time of receiving rescue therapy.|Generalized Wilcoxon Test||||
1681715|NCT01227512|3093230|Superiority or Other||Mean Difference (Final Values)|3.77||||0.0019||95.0|1.43|6.11||P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.|ANCOVA||||
1681716|NCT01227512|3093231|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.2702||95.0|-0.73|0.21||P-value was derived from a Cochran-Mantel-Haenszel (CMH) row mean scores test.|Cochran-Mantel-Haenszel||||
1681717|NCT01227512|3093232|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.5381||95.0|-0.57|0.3|||ANCOVA|P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.||P value corresponds to 72 hours post-dose.|
1681718|NCT01227512|3093232|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.315||95.0|-0.57|0.19|||ANCOVA|P-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.||P value corresponds to 24 hours post-dose.|
1681719|NCT01227512|3093233|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.146||95.0|-0.7|0.11||alpha level was set at 0.05. p-value was derived from an ANCOVA model with treatment and clinical center as factors and baseline value as covariate.|ANCOVA|Includes factors of treatment, study center and covariate baseline.|||
1681720|NCT01227512|3093234|Superiority or Other|||||||0.9495||||||The alpha level was set at 0.05|Generalized Wilcoxon Test|Participants who used rescue therapy within first 7 days of treatment period were censored at time they started the rescue therapy.|||
1681721|NCT01227434|3093236|Superiority or Other||Exact binomial distribution|0.1||||0.1|2-Sided||||||Exact binomial distribution|||Compared to historical estimates of PFS-6 months. With 30 patients, there would be 90% power to detect an improvement in the PFS-6 months rate from 10% (historical estimate) to 30% based on a one-sided exact test with alpha=0.1.|
1681722|NCT01227395|3093254|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs)."|
1681723|NCT01227395|3093255|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction  in the frequency of Treatment Related Adverse Events(TRAEs)."|
1681724|NCT01227395|3093256|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the frequency of Treatment Related Adverse Events(TRAEs)."|
1681725|NCT01227395|3093257|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between <65 years and >=65 years  in the frequency of Treatment Related Adverse Events(TRAEs)."|
1681726|NCT01227395|3093258|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Allergies. The null hypothesis is there is no difference between with and without allergies in the frequency of Treatment Related Adverse Events(TRAEs)."|
1681727|NCT01227395|3093259|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction  in the frequency of Treatment Related Adverse Events(TRAEs)."|
1681728|NCT01227395|3093260|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was concomitant drugs. The null hypothesis is there is no difference between with and without concomitant drugs  in the frequency of Treatment Related Adverse Events(TRAEs)."|
1681729|NCT01227395|3093261|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the frequency of Treatment Related Adverse Events(TRAEs)."|
1681730|NCT01227395|3093262|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between <65 years and >=65 years  in the frequency of Treatment Related Adverse Events(TRAEs)."|
1681731|NCT01227278|3093281|Superiority or Other||Rate ratio|1.03||||0.941|2-Sided|95.0|0.67|1.58|||Van Elteren Test|Day 1 to 393: Van Elteren test was used to compare the two arms.|95 percent (%) confidence interval (CI) for rate ratio was based on normal approximation assuming rate with Poisson distribution.||
1681924|NCT01222520|3093755|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1681737|NCT01227265|3093287|Superiority or Other||Estimated Difference in Percentage|7.0||||0.244|2-Sided|95.0|-4.17|18.05||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline average OFF time (hours/day) as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|Mixed Models Analysis||||
1681738|NCT01227265|3093288|Superiority or Other||Difference in Estimated Means|-0.3||||0.2364|2-Sided|95.0|-0.86|0.21|||cLDA||||
1681739|NCT01227265|3093288|Superiority or Other||Difference in Estimated Means|-0.2||||0.4933|2-Sided|95.0|-0.72|0.35|||cLDA||||
1681740|NCT01227057|3093295|Non-Inferiority or Equivalence|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.|||||>|0.1||||||P value is for the group x time interaction.|ANOVA||||
1681741|NCT01227057|3093296|Non-Inferiority or Equivalence|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.||||||0.04||||||P value is for the group x time interaction.|Mixed Models Analysis|Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.||Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.|
1681742|NCT01227057|3093297|Non-Inferiority or Equivalence|Power calculations were based on the SI-R using effect size estimates from a previous trial comparing individual CBT with a Wait List (WL) control (Steketee2010). In this study, the effect size of Cognitive Behavioral Therapy (CBT) relative to WL was d = 2.21 on the SI-R. Accounting for a smaller effect size due to having an active control condition, we expected to have 80% power to detect a large (d = .80) effect size. The sample assessed for eligibility (n = 67) was 99% of this target.||||||0.029||||||P value is for the group x time interaction.|Mixed Models Analysis|Adjusted for age, years of education, and presence of co-morbid obsessive-compulsive disorder due to group differences at baseline.||Linear mixed models with random intercepts were used to evaluate the change in primary and secondary outcome variables over time, the effect of group, the effect of treatment, and the treatment group by time interaction, both for the treatment phase (0-6 months) and follow up phase (6-12 months). All analyses (0-6 months) were conducted first using observed data only (i.e., completer analysis) and then using an intent to treat (ITT) sample.|
1681743|NCT01226706|3093331|Superiority or Other|||||||0.888|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681744|NCT01226706|3093332|Superiority or Other|||||||0.013|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681745|NCT01226706|3093333|Superiority or Other|||||||0.314|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681746|NCT01226706|3093334|Superiority or Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681747|NCT01226706|3093335|Superiority or Other|||||||0.072|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681748|NCT01226706|3093336|Superiority or Other|||||||0.132|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681749|NCT01226706|3093337|Superiority or Other|||||||0.099|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681750|NCT01226706|3093338|Superiority or Other|||||||0.085|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681751|NCT01226706|3093339|Superiority or Other|||||||0.132|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681752|NCT01226706|3093340|Superiority or Other|||||||0.029|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681753|NCT01226706|3093341|Superiority or Other|||||||0.557|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681754|NCT01226706|3093342|Superiority or Other|||||||0.051|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681755|NCT01226706|3093343|Superiority or Other|||||||0.051|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681756|NCT01226706|3093344|Superiority or Other|||||||0.173|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681757|NCT01226706|3093345|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.013|2-Sided|95.0|-2.0|-0.4|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681758|NCT01226706|3093346|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.007|2-Sided|95.0|-2.1|-0.5|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681759|NCT01226706|3093347|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.021|2-Sided|95.0|-2.1|-0.2|||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681760|NCT01226706|3093351|Superiority or Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681761|NCT01226706|3093352|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681762|NCT01226706|3093353|Superiority or Other|||||||0.904|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons|||
1681976|NCT01221597|3093899|Superiority or Other|||||||0.3085|||||||ANOVA||||
1681769|NCT01226706|3093366|Superiority or Other|||||||0.016|||||||Wilcoxon (Mann-Whitney)|A Bonferroni correction (0.05/n) was used for multiple comparisons||"A sample of 16 subjects per group was required to detect a mean difference of 50 mL in maximum capacity at cystoscopy between botulinum toxin and placebo at 90% power with a two-sided type I error of 5%.~Difference scores were computed for the primary outcome, which were then compared using the Wilcoxon- Mann-Whitney U test. This type of analysis was used to identify both between group differences and within group differences (over time) while using non-parametric statistics."|
1681770|NCT01226511|3093380|Superiority or Other||Least squares (LS) mean difference|-2.65|Standard Error of the Mean|0.7|<|0.001|2-Sided|95.0|-4.03|-1.27|||Mixed Models Analysis||||
1681771|NCT01226459|3093390|Superiority or Other||Mean Difference (Final Values)|0.69|||<|0.0001|2-Sided|95.0|0.35|1.04|||ANCOVA||||
1681772|NCT01226459|3093391|Superiority or Other||Mean Difference (Final Values)|10.8|||<|0.0001|2-Sided|95.0|7.0|14.7|||ANCOVA|P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is of the change from baseline to week 12 data.|
1681773|NCT01226459|3093392|Superiority or Other||Mean Difference (Final Values)|9.1|||<|0.0001|2-Sided|95.0|5.0|13.1|||ANCOVA|P-value is from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Intent to Treat (ITT) population defined as all participants randomly assigned to a treatment group who received dispensed investigational product. Four participants in vehicle group and 3 participants in foam group had no hair information at Baseline. Statistical analysis is of the change from baseline to week 24 data.|
1681774|NCT01226095|3093405|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1681775|NCT01226043|3093417|Superiority or Other||Mean Difference (Net)|2.3|||<|0.0001|2-Sided|95.0|2.15|2.44|||ANOVA|The last observation carried forward (LOCF) method was applied to impute missing Week 4 overall patient preference values for ANOVA analysis.||The hypothesis was to determine whether patients have higher preference score for Lantus® SoloSTAR® pen compared to Lantus® vial/syringe. Differences of patient preference score greater than 0.5 were considered clinically meaningful. The power for detecting a true difference of 0.5 considering a standard deviation from 1.6 to 2.5, assuming 130 evaluable patients per arm and a two-sided test at 0.05 significance level ranged from 89% to more than 99%.|
1681776|NCT01225835|3093456|Superiority or Other|||||||1||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Fisher Exact||||
1681777|NCT01225835|3093457|Superiority or Other|||||||0.405||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)||||
1681778|NCT01225835|3093458|Superiority or Other|||||||0.295||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)||||
1681779|NCT01225835|3093459|Superiority or Other|||||||0.69||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Fisher Exact||||
1681780|NCT01225835|3093460|Superiority or Other|||||||0.478||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|t-test, 2 sided||||
1681781|NCT01225835|3093461|Superiority or Other|||||||0.62||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|t-test, 2 sided||||
1681782|NCT01225835|3093462|Superiority or Other||||||<|0.001||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)||||
1681783|NCT01225835|3093463|Superiority or Other|||||||0.871||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Chi-squared||||
1681784|NCT01225835|3093464|Superiority or Other|||||||0.482||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)||||
1681785|NCT01225835|3093466|Superiority or Other||||||<|0.001||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)||||
1681786|NCT01225835|3093467|Superiority or Other||||||<|0.001||||||Level of significance is 0.05.|Wilcoxon (Mann-Whitney)||||
1681787|NCT01225835|3093468|Superiority or Other|||||||0.121||||||The significance level is 0.05.|t-test, 2 sided||||
1681788|NCT01225835|3093469|Superiority or Other|||||||0.004||||||The significance level is 0.05. P-values are not adjusted for multiple tests and have to be interpreted exploratively.|Wilcoxon (Mann-Whitney)||||
1681789|NCT01225835|3093470|Superiority or Other|||||||1||||||The significance level is 0.05.|Fisher Exact||||
1681790|NCT01225835|3093472|Superiority or Other|||||||0.027||||||The significance level is 0.05.|t-test, 2 sided|||Age >= 39 years|
1681791|NCT01225835|3093472|Superiority or Other|||||||0.015||||||The significance level is 0.05.|t-test, 2 sided|||Age < 39 years|
1681792|NCT01225835|3093472|Superiority or Other|||||||0.003||||||The significance level is 0.05.|t-test, 2 sided||||
1681793|NCT01225822|3093477|Superiority or Other||Odds Ratio (OR)|1.15||||0.7104|2-Sided|95.0|0.55|2.403|||Regression, Logistic||||
1681794|NCT01225822|3093477|Superiority or Other||Odds Ratio (OR)|1.522||||0.2375|2-Sided|95.0|0.758|3.058|||Regression, Logistic||||
1681795|NCT01225822|3093477|Superiority or Other||Odds Ratio (OR)|0.068||||0.0097|2-Sided|95.0|0.009|0.522|||Regression, Logistic||||
1681796|NCT01225822|3093477|Superiority or Other||Odds Ratio (OR)|0.919||||0.7973|2-Sided|95.0|0.483|1.75|||Regression, Logistic||||
1681797|NCT01225822|3093477|Superiority or Other||Odds Ratio (OR)|22.338||||0.0025|2-Sided|95.0|2.983|167.268|||Regression, Logistic||||
1681798|NCT01225822|3093477|Superiority or Other||Odds Ratio (OR)|16.871||||0.0063|2-Sided|95.0|2.221|128.142|||Regression, Logistic||||
1681799|NCT01225822|3093479|Superiority or Other||Odds Ratio (OR)|1.917||||0.1448||95.0|0.799|4.597|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint|
1681800|NCT01225822|3093479|Superiority or Other||Odds Ratio (OR)|2.049||||0.1043||95.0|0.862|4.868|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as for primary endpoint|
1681977|NCT01221597|3093900|Superiority or Other|||||||0.08|||||||ANOVA||||
1681805|NCT01225822|3093480|Superiority or Other||Odds Ratio (OR)|0.269||||0.0113||95.0|0.097|0.743|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.|
1681806|NCT01225822|3093480|Superiority or Other||Odds Ratio (OR)|0.556||||0.1678||95.0|0.242|1.28|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.|
1681807|NCT01225822|3093480|Superiority or Other||Odds Ratio (OR)|0.809||||0.5663||95.0|0.393|1.668|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.|
1681808|NCT01225822|3093480|Superiority or Other||Odds Ratio (OR)|0.616||||0.3674||95.0|0.215|1.766|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as primary endpoint.|
1681809|NCT01225822|3093480|Superiority or Other||Odds Ratio (OR)|0.687||||0.3884||95.0|0.293|1.611|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.|
1681810|NCT01225822|3093480|Superiority or Other||Odds Ratio (OR)|0.332||||0.036||95.0|0.118|0.931|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.|
1681811|NCT01225822|3093481|Superiority or Other||Odds Ratio (OR)|0.269||||0.0114||95.0|0.097|0.744|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.|
1681812|NCT01225822|3093481|Superiority or Other||Odds Ratio (OR)|0.674||||0.3253||95.0|0.307|1.48|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.|
1681813|NCT01225822|3093481|Superiority or Other||Odds Ratio (OR)|0.805||||0.5566||95.0|0.39|1.66|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd, same methodology as primary endpoint.|
1681814|NCT01225822|3093481|Superiority or Other||Odds Ratio (OR)|0.505||||0.1882||95.0|0.183|1.397|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 300 mg qd, same methodology as primary endpoint.|
1681815|NCT01225822|3093481|Superiority or Other||Odds Ratio (OR)|0.837||||0.6659||95.0|0.374|1.875|||Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.|
1681816|NCT01225822|3093481|Superiority or Other||Odds Ratio (OR)|0.334||||0.0373||95.0|0.199|0.938|||Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid, same methodology as primary endpoint.|
1681817|NCT01225822|3093482|Superiority or Other||Odds Ratio (OR)|1.249||||0.2446||95.0|0.859|1.817|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.|
1681818|NCT01225822|3093482|Superiority or Other||Odds Ratio (OR)|0.647||||0.0401||95.0|0.427|0.98|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.|
1681819|NCT01225822|3093482|Superiority or Other||Odds Ratio (OR)|0.469||||0.0007||95.0|0.302|0.727|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.|
1681820|NCT01225822|3093482|Superiority or Other||Odds Ratio (OR)|0.94||||0.7856||95.0|0.599|1.473|||Regression, Logistic|||BIBR 1048 300 mg qd vs. BIBR 1048 150 mg bid comparison. Secondary analysis to compare once daily dosing vs. twice daily dosing. . The statistical model was a logistic regression which included treatment and centre.|
1681821|NCT01225822|3093482|Superiority or Other||Odds Ratio (OR)|0.518||||0.0015||95.0|0.344|0.778||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..|
1681822|NCT01225822|3093482|Superiority or Other||Odds Ratio (OR)|0.375|||<|0.0001||95.0|0.244|0.577||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..|
1681823|NCT01225822|3093483|Superiority or Other||Odds Ratio (OR)|1.249||||0.2446||95.0|0.859|1.817|||Regression, Logistic|||BIBR 1048 50 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.|
1681824|NCT01225822|3093483|Superiority or Other||Odds Ratio (OR)|0.647||||0.0401||95.0|0.427|0.98|||Regression, Logistic|||BIBR 1048 150 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.|
1681825|NCT01225822|3093483|Superiority or Other||Odds Ratio (OR)|0.469||||0.0007||95.0|0.302|0.727|||Regression, Logistic|||BIBR 1048 225 mg bid vs. Enoxaparin 40 mg qd comparison. Secondary analysis, active control used as reference. The statistical model was a logistic regression which included treatment and centre.|
1681826|NCT01225822|3093483|Superiority or Other||Odds Ratio (OR)|0.94||||0.7856||95.0|0.599|1.473|||Regression, Logistic|||BIBR 1048 300 mg qd vs. BIBR 1048 150 mg bid comparison. Secondary analysis to compare once daily dosing vs. twice daily dosing. . The statistical model was a logistic regression which included treatment and centre.|
1681827|NCT01225822|3093483|Superiority or Other||Odds Ratio (OR)|0.518||||0.0015||95.0|0.344|0.778||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 150 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..|
1681862|NCT01225055|3093560|Superiority|||||||0.2||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA|||
1681863|NCT01225055|3093560|Superiority|||||||0.34||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA|||
1681828|NCT01225822|3093483|Superiority or Other||Odds Ratio (OR)|0.375|||<|0.0001||95.0|0.244|0.577||Dose relationship tested using a hierarchical testing procedure to preserve type I error rate at 5%. 225 mg bid was compared to 50 mg bid. If a difference significant at 5% level was found, then 150 mg bid was compared to 50 mg bid|Regression, Logistic|||BIBR 1048 225 mg bid vs. BIBR 1048 50 mg bid comparison. The primary objective of the trial was to establish a dose relationship among BIBR 1048 doses studied in the prevention of VTE. The statistical model was a logistic regression which included treatment and centre..|
1681829|NCT01225731|3093494|Superiority or Other||% Difference in Response Rate|72.2|||<|0.001|2-Sided|95.0|62.02|82.37|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).|||
1681830|NCT01225731|3093494|Superiority or Other||% Difference in Response Rate|59.58|||<|0.001|2-Sided|95.0|48.6|70.55|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).|||
1681831|NCT01225731|3093494|Superiority or Other||% Difference in Response Rate|55.56|||<|0.001|2-Sided|95.0|44.48|66.63|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).|||
1681832|NCT01225731|3093494|Superiority or Other||% Difference in Response Rate|31.11|||<|0.001|2-Sided|95.0|16.22|46.0|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).|||
1681833|NCT01225731|3093495|Superiority or Other||% Difference in Response Rate|67.65|||<|0.001|2-Sided|95.0|56.42|78.88|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).|||
1681834|NCT01225731|3093495|Superiority or Other||% Difference in Response Rate|56.23|||<|0.001|2-Sided|95.0|44.43|68.03|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).|||
1681835|NCT01225731|3093495|Superiority or Other||% Difference in Response Rate|54.44|||<|0.001|2-Sided|95.0|42.63|66.26|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).|||
1681836|NCT01225731|3093495|Superiority or Other||% Difference in Response Rate|19.37|||<|0.009|2-Sided|95.0|5.15|33.58|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).|||
1681837|NCT01225731|3093496|Superiority or Other||% Difference in Response Rate|69.97|||<|0.001|2-Sided|95.0|58.96|80.99|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).|||
1681838|NCT01225731|3093496|Superiority or Other||% Difference in Response Rate|61.85|||<|0.001|2-Sided|95.0|50.33|73.37|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).|||
1681839|NCT01225731|3093496|Superiority or Other||% Difference in Response Rate|60.0|||<|0.001|2-Sided|95.0|48.42|71.58|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).|||
1681840|NCT01225731|3093496|Superiority or Other||% Difference in Response Rate|28.89|||<|0.001|2-Sided|95.0|13.41|44.36|||Cochran-Mantel-Haenszel|Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).|||
1681841|NCT01225562|3093497|Superiority or Other||Hazard Ratio (HR)|2.32|||<|0.0001|2-Sided|95.0|1.68|3.21|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard||
1681842|NCT01225562|3093497|Superiority or Other||Hazard Ratio (HR)|2.69|||<|0.0001|2-Sided|95.0|1.96|3.7|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard||
1681843|NCT01225562|3093498|Superiority or Other||Hazard Ratio (HR)|0.89||||0.135|2-Sided|95.0|0.76|1.04|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard||
1681844|NCT01225562|3093498|Superiority or Other||Hazard Ratio (HR)|1.0||||0.9851|2-Sided|95.0|0.86|1.16|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard||
1681845|NCT01225562|3093499|Superiority or Other||Hazard Ratio (HR)|0.83||||0.0676|2-Sided|95.0|0.68|1.01|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard||
1681846|NCT01225562|3093499|Superiority or Other||Hazard Ratio (HR)|0.87||||0.1547|2-Sided|95.0|0.71|1.06|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard||
1681847|NCT01225562|3093500|Superiority or Other||Hazard Ratio (HR)|0.84||||0.0043|2-Sided|95.0|0.74|0.95|||Regression, Cox||The hazard ratio shows ticagrelor 60 mg hazard / placebo hazard||
1681848|NCT01225562|3093500|Superiority or Other||Hazard Ratio (HR)|0.85||||0.008|2-Sided|95.0|0.75|0.96|||Regression, Cox||The hazard ratio shows ticagrelor 90 mg hazard / placebo hazard||
1681849|NCT01225289|3093519|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1681850|NCT01225211|3093536|Superiority or Other||LS Mean difference|0.6||||0.5978|2-Sided|95.0|-1.66|2.86|||Mixed Model Repeated Measure (MMRM)||||
1681851|NCT01225211|3093537|Superiority or Other||LS Mean difference|-3.78||||0.365|2-Sided|95.0|-12.028|4.467|||ANCOVA||||
1681852|NCT01225211|3093537|Superiority or Other||LS Mean difference|-2.867||||0.396|2-Sided|95.0|-9.543|3.81|||ANCOVA||||
1681853|NCT01225211|3093537|Superiority or Other||LS Mean difference|-4.526||||0.161|2-Sided|95.0|-10.888|1.835|||ANCOVA||||
1681854|NCT01225211|3093537|Superiority or Other||LS Mean difference|-2.67||||0.409|2-Sided|95.0|-9.053|3.712|||ANCOVA||||
1681855|NCT01225211|3093537|Superiority or Other||LS Mean difference|-1.306||||0.68|2-Sided|95.0|-7.565|4.953|||ANCOVA||||
1681856|NCT01225211|3093538|Superiority or Other||LS Mean difference|-9.676|||<|0.001|2-Sided|95.0|-14.801|-4.551|||ANCOVA||||
1681857|NCT01225211|3093538|Superiority or Other||LS Mean difference|-2.679|||<|0.267|2-Sided|95.0|-7.484|2.125|||ANCOVA||||
1681858|NCT01225068|3093558|Superiority or Other||effect size|0.22||||||||||||||effect size is endpoint and not comparison|
1681859|NCT01225055|3093559|Superiority|||||||0.04||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA|||
1681860|NCT01225055|3093559|Superiority|||||||0.01||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA|||
1681861|NCT01225055|3093559|Superiority|||||||0||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA|||
1681868|NCT01225055|3093562|Superiority|||||||0.44||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA|||
1681869|NCT01225055|3093562|Superiority|||||||0.58||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA|||
1681870|NCT01225055|3093562|Superiority|||||||0.72||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA|||
1681871|NCT01225055|3093563|Superiority|||||||0.09||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA|||
1681872|NCT01225055|3093563|Superiority|||||||0||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA|||
1681873|NCT01225055|3093563|Superiority|||||||0.64||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA|||
1681874|NCT01225055|3093564|Superiority|||||||0.26||||||calculated p-value indicating the effect of different treatment groups and time points|ANOVA|Repeated measures ANOVA|||
1681875|NCT01225055|3093564|Superiority|||||||0.64||||||calculated p-value indicating the effect of different time points|ANOVA|Repeated measures ANOVA|||
1681876|NCT01225055|3093564|Superiority|||||||0.84||||||calculated p-value indicating the effect of different treatment groups|ANOVA|Repeated measures ANOVA|||
1681877|NCT01224925|3093568|Superiority||||||>|0.05|||||||Chi-squared||||
1681878|NCT01224925|3093569|Superiority||Log Rank (Mantel-Cox)|1201.0|||<|0.01|2-Sided|95.0|1068.0|1335.0|||Log Rank||||
1681879|NCT01224925|3093569|Superiority||Log Rank (Mantel-Cox)|842.0|||<|0.01|2-Sided|95.0|693.0|991.0|||Log Rank|||The power calculation was based on the intention to show a 30% difference in success rates. The following parameters were used (binomial scale): type I error: 5%; expected success rate in the CH group: 55% (based on Barthel et al. 2000); minimal difference between success rates not to be overlooked: 30%; type II error: 5%. The calculations revealed the need for 64 subjects in each group. After adding 20% for eventual drop-outs, we planned to recruit 160 subjects in one year.|
1681880|NCT01224171|3093621|Superiority or Other||Risk Difference (RD)|3.0||||0.4332|2-Sided|95.0|-4.5|10.5|||Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|Clinical remission was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level with stratification according to concomitant use of oral corticosteroids and concomitant use of immunomodulators (6-mercaptopurine [6-MP], azathioprine, or methotrexate) for the TNFα antagonist failure subpopulation.|
1681881|NCT01223937|3093633|Superiority or Other||Mean Difference (Final Values)|-72.91||||0.1829|2-Sided|95.0|-180.42|34.6||A priori threshold for significance was p<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (<65, >=65) and baseline 24-hour urine volume, using last observation carried forward.|||
1681882|NCT01223937|3093634|Superiority or Other||Mean Difference (Final Values)|-83.56||||0.0031|2-Sided|95.0|-138.74|-28.38||A priori threshold for significance was p<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (<65, >=65) and baseline nocturnal urine volume, using last observation carried forward.|||
1681883|NCT01223937|3093635|Superiority or Other||Mean Difference (Final Values)|49.03||||0.0034|2-Sided|95.0|16.35|81.7||A priori threshold for significance was p<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (<65, >=65) and baseline time to first nocturnal void, using last observation carried forward.|||
1681884|NCT01223937|3093636|Superiority or Other||Odds Ratio (OR)|1.73||||0.0586|2-Sided|95.0|0.98|3.05||A priori threshold for significance was p<=0.05.|Regression, Logistic|Logistical regression of 33% responder status adjusted for age (<65, >=65) and baseline nocturnal voids using last observation carried forward.|||
1681885|NCT01223937|3093637|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.0104|2-Sided|95.0|-0.54|-0.07||A priori threshold for significance was p<=0.05.|ANCOVA|ANCOVA of change from baseline adjusted for age (<65, >=65) and baseline nocturnal voids, using last observation carried forward.||Change from baseline in the adjusted mean number of nocturnal voids in the FAS using LOCF.|
1681886|NCT01223937|3093638|Superiority or Other||Odds Ratio (OR)|1.85||||0.0061|2-Sided|95.0|1.19|2.86||A priori threshold for significance was p<=0.05.|Generalized Estimating Equation (GEE)|GEE Method with treatment, visit (including a treatment-by-visit interaction term), and age stratification (<65, ≥65 years) as factors.||The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary outcomes.|
1681887|NCT01223937|3093639|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.028|2-Sided|95.0|-0.42|-0.02||A priori threshold for significance was p<=0.05.|ANCOVA|Repeated measures ANCOVA with treatment, visit (including a treatment-by-visit interaction term), and age stratification (<65, ≥65 years) as factors.||"The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary outcomes.~A summary of mean change in nocturnal voids, assessed longitudinally during 3 months of treatment, is presented below for the FAS using LOCF."|
1681888|NCT01223703|3093642|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.|||
1681889|NCT01223703|3093643|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|The analysis was done following an intention-to-treat approach by means of the unpaired student t test or Wilcoxon rank sum test as appropriated.||"null hypothesis is no difference n3 PUFA administration and placebo. To demonstrate an effect size of 0.5 in LVEF, a sample of 65 patients in each group was calculated to have 80% power to detect such 0.5 effect size with alpha=0.05 (2-tailed) at the Student t test.~for unpaired data."|
1681890|NCT01223352|3093671|Superiority or Other||Ratio of geometric means|0.71|||||2-Sided|95.0|0.48|1.05|||||b.i.d. bosentan regimen was taken as reference||
1681891|NCT01223352|3093672|Superiority or Other||Ratio of geometric means|0.85|||||2-Sided|95.0|0.61|1.2|||||b.i.d. bosentan regimen was taken as reference||
1681892|NCT01223196|3093676|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in Heamoglobin A1c between groups.||Mann-Whitney test was used to test differences Haemoglobin A1C between groups. Treatment-induced changes were examined by Wilcoxon’s rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).|
1681893|NCT01223196|3093677|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|Statistical Analysis applies toTNF (Tumor Necrosis Factor) alpha converting enzyme (TACE) activity between Pioglitazone and Placebo after 6 months.||Statistical analysis 2 also used 2-sided t-test similar to Statistical analysis -1|
1681894|NCT01223196|3093677|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups.||Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups. Treatment-induced changes were examined by Wilcoxon’s rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).|
1681895|NCT01223196|3093678|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups.|||
1681896|NCT01223196|3093678|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|Mann-Whitney test was used to test differences in M/I. Statistical Analysis applies to (M/I) between Pioglitazone and Placebo after 6 months.||Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups. Treatment-induced changes were examined by Wilcoxon’s rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences 20), Chicago, IL, USA).|
1681897|NCT01223183|3093679|Equivalence|alpha=0.05||||||0.003|||||||t-test, 2 sided|||Comparing mucociliary clearance after isotonic saline inhalation to mucociliary clearance after hypertonic saline inhalation|
1681898|NCT01223183|3093681|Equivalence|alpha=0.05|||||<|0.001|||||||t-test, 2 sided|||Comparing DTPA absorption after hypertonic saline inhalation to DTPA absorption after isotonic saline inhalation|
1681899|NCT01222715|3093706|Superiority or Other|||||||0.0124|||||||Log Rank|||The event free survival distributions of patients in Regimen A and Regimen B were compared using the log-rank test.|
1681900|NCT01222533|3093743|Superiority or Other||Mean Difference (Final Values)|0.339|Standard Error of the Mean|0.023|<|0.0001||95.0|0.294|0.384|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo||
1681901|NCT01222533|3093743|Superiority or Other||Mean Difference (Final Values)|0.324|Standard Error of the Mean|0.023|<|0.0001||95.0|0.279|0.369|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo||
1681902|NCT01222533|3093743|Superiority or Other||Mean Difference (Final Values)|0.281|Standard Error of the Mean|0.023|<|||95.0|0.236|0.325|||||Tio R1.25-Placebo||
1681903|NCT01222533|3093744|Superiority or Other||Mean Difference (Final Values)|0.335|Standard Error of the Mean|0.022|<|0.0001||95.0|0.292|0.378|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo||
1681904|NCT01222533|3093744|Superiority or Other||Mean Difference (Final Values)|0.319|Standard Error of the Mean|0.022|<|0.0001||95.0|0.276|0.362|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo||
1681905|NCT01222533|3093744|Superiority or Other||Mean Difference (Final Values)|0.283|Standard Error of the Mean|0.022|<|||95.0|0.241|0.326|||||Tio R1.25-Placebo||
1681906|NCT01222533|3093745|Superiority or Other||Mean Difference (Final Values)|0.236|Standard Error of the Mean|0.028|<|0.0001||95.0|0.18|0.292|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo||
1681907|NCT01222533|3093745|Superiority or Other||Mean Difference (Final Values)|0.188|Standard Error of the Mean|0.028|<|0.0001||95.0|0.133|0.244|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo||
1681908|NCT01222533|3093745|Superiority or Other||Mean Difference (Final Values)|0.138|Standard Error of the Mean|0.028|<|||95.0|0.083|0.194|||||Tio R1.25-Placebo||
1681909|NCT01222533|3093746|Superiority or Other||Mean Difference (Final Values)|0.187|Standard Error of the Mean|0.013|<|0.0001||95.0|0.162|0.211|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo||
1681910|NCT01222533|3093746|Superiority or Other||Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.013|<|0.0001||95.0|0.155|0.205|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo||
1681911|NCT01222533|3093746|Superiority or Other||Mean Difference (Final Values)|0.155|Standard Error of the Mean|0.013|<|||95.0|0.13|0.18|||||Tio R1.25-Placebo||
1681912|NCT01222533|3093747|Superiority or Other||Mean Difference (Final Values)|0.191|Standard Error of the Mean|0.012|<|0.0001||95.0|0.167|0.216|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo||
1681913|NCT01222533|3093747|Superiority or Other||Mean Difference (Final Values)|0.185|Standard Error of the Mean|0.012|<|0.0001||95.0|0.161|0.209|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo||
1681914|NCT01222533|3093747|Superiority or Other||Mean Difference (Final Values)|0.165|Standard Error of the Mean|0.012|<|||95.0|0.141|0.189|||||Tio R1.25-Placebo.||
1681915|NCT01222533|3093748|Superiority or Other||Mean Difference (Final Values)|0.121|Standard Error of the Mean|0.014|<|0.0001||95.0|0.094|0.148|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R5-Placebo||
1681916|NCT01222533|3093748|Superiority or Other||Mean Difference (Final Values)|0.101|Standard Error of the Mean|0.014|<|0.0001||95.0|0.074|0.128|||ANOVA|Adjusted for sequence, patients within sequences, period and treatment.|Tio R2.5-Placebo||
1681917|NCT01222533|3093748|Superiority or Other||Mean Difference (Final Values)|0.087|Standard Error of the Mean|0.014|<|||95.0|0.06|0.114|||||Tio R1.25-Placebo||
1681918|NCT01222533|3093749|Non-Inferiority or Equivalence|The standard bioequivalence range of 80 to 125% was pre-specified for AUC0-6,ss in order to assess the relative systemic exposure following inhalation of Tio R5 compared to Tio HH18. Bioequivalence was not used as a surrogate for efficacy.|Geometric mean ratio (percentage)|75.99|Standard Deviation|34.1||0.8683||90.0|70.44|81.98||Maximum of two one-sided p-values for geometric mean ratio being outside interval 80 percent to 125 percent.|ANOVA||Standard deviation is actually the geometric coefficient of variation.||
1681919|NCT01222533|3093750|Non-Inferiority or Equivalence|The standard bioequivalence range of 80 to 125% was pre-specified for Cmax,ss in order to assess the relative systemic exposure following inhalation of Tio R5 compared to Tio HH18. Bioequivalence was not used as a surrogate for efficacy.|Geometric mean ratio (percentage)|80.66|Standard Deviation|43.4||0.4423||90.0|73.49|88.52||Maximum of two one-sided p-values for geometric mean ratio being outside interval 80 percent to 125 percent.|ANOVA||Standard deviation is actually the geometric coefficient of variation.||
1681920|NCT01222520|3093751|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1681921|NCT01222520|3093752|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1681927|NCT01222494|3093759|Superiority|||||||0.003||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p < 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.|
1681928|NCT01222494|3093760|Superiority|||||||0.7||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p < 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.|
1681929|NCT01222494|3093761|Superiority|||||||0.04||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p < 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.|
1681930|NCT01222494|3093762|Superiority|||||||0.01||||||The p-value refers to the treatment group term in the model. The a priori threshold for statistical significance in this planned primary test was p < 0.05.|ANCOVA|||An ANCOVA was used to test for differences between groups at endpoint, controlling for baseline values.|
1681931|NCT01222247|3093784|Superiority|||||||0.11|||||||Wilcoxon (Mann-Whitney)||||
1681932|NCT01222247|3093785|Superiority or Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Analysis for interval from randomization to delivery|
1681933|NCT01222247|3093786|Superiority or Other||Risk Ratio (RR)|1.03||||0.56|2-Sided|95.0|0.93|1.15|||Chi-squared|||Statistical analysis for cesarean delivery|
1681934|NCT01222247|3093786|Superiority or Other||Risk Ratio (RR)|0.98||||0.96|2-Sided|95.0|0.49|1.95|||Chi-squared|||Analysis for Postpartum Endometritis|
1681935|NCT01222247|3093786|Superiority or Other||Risk Ratio (RR)|0.61||||0.08|2-Sided|95.0|0.35|1.07|||Chi-squared|||Statistical analysis for chorioamnionitis|
1681936|NCT01222247|3093787|Superiority or Other|||||||0.2|||||||Wilcoxon (Mann-Whitney)||||
1681937|NCT01222247|3093788|Superiority or Other||Risk Ratio (RR)|0.89||||0.03|2-Sided|95.0|0.8|0.98|||Chi-squared|||Analysis for duration greater than or equal to 3 days|
1681938|NCT01222247|3093788|Superiority or Other||Risk Ratio (RR)|0.93||||0.09|2-Sided|95.0|0.85|1.01|||Chi-squared|||Analysis for NICU stay of any duration|
1681939|NCT01222247|3093789|Superiority or Other||Risk Ratio (RR)|1.16||||0.24|2-Sided|95.0|0.91|1.47|||Chi-squared||||
1681940|NCT01222247|3093790|Superiority or Other||Risk Ratio (RR)|1.17||||0.15|2-Sided|95.0|0.95|1.4|||Chi-squared||||
1681941|NCT01222247|3093791|Superiority or Other||Risk Ratio (RR)|0.93||||0.4|2-Sided|95.0|0.78|1.1|||Chi-squared||||
1681942|NCT01222247|3093792|Superiority or Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)||||
1681943|NCT01222247|3093793|Superiority or Other||Risk Ratio (RR)|1.6|||<|0.001|2-Sided|95.0|1.37|1.87|||Chi-squared||||
1681944|NCT01222247|3093794|Superiority or Other||Risk Ratio (RR)|0.88||||0.4|2-Sided|95.0|0.66|1.18|||Chi-squared||||
1681945|NCT01222247|3093796|Superiority or Other||Risk Ratio (RR)|0.8||||0.62|2-Sided|95.0|0.33|1.93|||Chi-squared||||
1681946|NCT01222247|3093798|Superiority or Other|||||||0.1|||||||Chi-squared||||
1681947|NCT01222247|3093799|Superiority or Other||Risk Ratio (RR)|1.14||||0.13|2-Sided|95.0|0.96|1.34|||Chi-squared||||
1681948|NCT01222247|3093800|Superiority or Other|||||||0.32|||||||Wilcoxon (Mann-Whitney)||||
1681949|NCT01222247|3093801|Superiority or Other|||||||0.5|||||||Chi-squared||||
1681950|NCT01222247|3093802|Superiority or Other||Risk Ratio (RR)|0.82||||0.74|2-Sided|95.0|0.25|2.68|||Chi-squared||||
1681951|NCT01222247|3093803|Superiority or Other||Risk Ratio (RR)|0.78||||0.004|2-Sided|95.0|0.66|0.93|||Chi-squared||||
1681952|NCT01222247|3093804|Superiority or Other||Risk Ratio (RR)|0.59||||0.03|2-Sided|95.0|0.37|0.96|||Chi-squared||||
1681953|NCT01222247|3093805|Superiority or Other||Risk Ratio (RR)|0.45||||0.1|2-Sided|95.0|0.17|1.19|||Chi-squared||||
1681954|NCT01222247|3093806|Superiority or Other||Risk Ratio (RR)|0.22||||0.04|2-Sided|95.0|0.02|0.92|||Chi-squared||||
1681955|NCT01222247|3093807|Superiority or Other||Risk Ratio (RR)|0.88||||0.57|2-Sided|95.0|0.55|1.39|||Chi-squared||||
1681956|NCT01222247|3093808|Superiority or Other||Risk Ratio (RR)|0.68||||0.002|2-Sided|95.0|0.53|0.87|||Chi-squared||||
1681957|NCT01222247|3093809|Superiority or Other||Risk Ratio (RR)|0.87||||0.36|2-Sided|95.0|0.65|1.17|||Chi-squared||||
1681958|NCT01222247|3093810|Superiority or Other||Risk Ratio (RR)|0.78||||0.003|2-Sided|95.0|0.66|0.92|||Chi-squared||||
1681959|NCT01222247|3093811|Superiority or Other||Risk Ratio (RR)|0.67|||<|0.001|2-Sided|95.0|0.53|0.84|||Chi-squared||||
1681960|NCT01222247|3093812|Superiority||Risk Ratio (RR)|0.78||||0.26|2-Sided|95.0|0.5|1.21|||Chi-squared|||Analysis for mechanical ventilation|
1681961|NCT01222247|3093812|Superiority||Risk Ratio (RR)|0.77||||0.17|2-Sided|95.0|0.53|1.12|||Chi-squared|||Analysis for Fraction of inspired oxygen|
1681962|NCT01222247|3093812|Superiority||Risk Ratio (RR)|0.77||||0.01|2-Sided|95.0|0.63|0.95|||Chi-squared|||Analysis for CPAP or high-flow nasal cannula|
1681963|NCT01222247|3093812|Superiority or Other||Risk Ratio (RR)|0.8||||0.02|2-Sided|95.0|0.66|0.97|||Chi-squared|||Analysis for Primary Outcome composite|
1681964|NCT01221623|3093887|Superiority or Other|||||||0.0249|||||||Cochran-Mantel-Haenszel||||
1681965|NCT01221623|3093888|Superiority or Other|||||||0.6949|||||||ANOVA||||
1681966|NCT01221623|3093889|Superiority or Other|||||||0.0248|||||||ANOVA||||
1681967|NCT01221623|3093890|Superiority or Other|||||||0.0144|||||||ANOVA||||
1681968|NCT01221623|3093891|Superiority or Other|||||||0.1168|||||||ANOVA||||
1681969|NCT01221623|3093892|Superiority or Other|||||||0.034|||||||ANOVA||||
1681970|NCT01221623|3093893|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1681971|NCT01221623|3093894|Superiority or Other|||||||0.0496|||||||ANOVA||||
1681972|NCT01221623|3093895|Superiority or Other|||||||0.0059|||||||ANOVA||||
1681973|NCT01221597|3093896|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1681974|NCT01221597|3093897|Superiority or Other|||||||0.7965|||||||ANOVA||||
1681975|NCT01221597|3093898|Superiority or Other|||||||0.6321|||||||ANOVA||||
1681982|NCT01221441|3093914|Superiority or Other||||||<|0.01|||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger’s method.||"The efficacy evaluation at week 104 evaluated Lysholm score with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in KOOS scores at week 104 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for Lysholm score is rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."|
1681983|NCT01221441|3093915|Superiority or Other||||||<|0.01|||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger’s method.||"The efficacy evaluation at week 104 evaluated KOOS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in KOOS scores at week 104 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for KOOS is rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."|
1681984|NCT01221441|3093916|Superiority or Other||||||<|0.01|||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger’s method.||"The primary efficacy evaluation based on IKDC and the VAS were tested at week 52 evaluated 100 mm VAS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in IKDC or VAS scores at week 52 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for both the IKDC and the VAS are rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."|
1681985|NCT01221441|3093917|Superiority or Other||||||<|0.01|||||||Mixed Models Analysis|Denominator degrees of freedom were adjusted using the Kenward-Roger’s method.||"The primary efficacy evaluation based on IKDC and the VAS were tested at week 52 evaluated 100 mm VAS with the following superiority hypothesis:~HO: μTG = μPC vs. HA: μTG ≠ μPC, where μTG and μPC are the mean change from baseline in IKDC or VAS scores at week 52 for patients in the TG-C and placebo control groups, respectively. If the null hypotheses for both the IKDC and the VAS are rejected, it the clinical effect of TG-C is concluded to be superior to that of the control."|
1681986|NCT01221285|3093946|Superiority or Other||Change|-42.8|||<|0.0001|2-Sided|95.0|-59.4|-26.2|||Change||Numerator is geometric mean post-baseline FAB. Denominator is baseline FAB.||
1681987|NCT01221285|3093947|Superiority or Other||Fold change|12.9|||<|0.0001|2-Sided|95.0|7.5|22.5|||Fold Change||Numerator is geometric mean post-baseline IgG4. Denominator is baseline IgG4.||
1681988|NCT01221285|3093948|Superiority or Other||Fold change|2.5|||<|0.0001|2-Sided|95.0|1.8|3.4|||Fold change||Numerator is geometric mean post-baseline IgG. Denominator is baseline IgG.||
1681989|NCT01221285|3093949|Superiority or Other||Fold change|1.8||||0.02|2-Sided|95.0|1.1|2.8|||Fold change||Numerator is geometric mean post-baseline IgE. Denominator is baseline IgE.||
1681990|NCT01221272|3093955|Superiority or Other||Mixed Models Analysis|0.65||||0.22|2-Sided|95.0|-0.4|1.7||The null hypothesis that ranolazine treatment had no effect on TPD would be rejected if the PDS and TPD p-values were less than 0.05 or the TPD p-value was less than 0.05/2 = 0.025.|Mixed Models Analysis||||
1681991|NCT01221272|3093956|Superiority or Other||Mixed Models Analysis|0.67||||0.29|2-Sided|95.0|-0.6|1.9||The null hypothesis that ranolazine treatment had no effect on PDS would be rejected if the PDS and TPD p-values were less than 0.05 or the PDS p-value was less than 0.05/2 = 0.025.|Mixed Models Analysis||||
1681992|NCT01221233|3093957|Superiority||Median Difference (Final Values)|17.6||||1|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1681993|NCT01221090|3093959|Superiority or Other|||||||0.3067||||||A priori threshold for statistical significance is <0.05|Regression, Linear|Robust variance estimation.||"This analysis was to compare the quality of life measure, Number of days poor physical/mental health prevented usual activity in the past 30 days at the 12 month follow-up visit."|
1681994|NCT01221090|3093959|Superiority or Other|||||||0.997||||||A priori threshold for statistical significance is <0.05|Regression, Linear|Robust variance estimation.||"This analysis was to compare the quality of life measure, Number of days mental health was not good in the past 30 days at the 12 month follow-up visit."|
1681995|NCT01221090|3093959|Superiority or Other|||||||0.685||||||A priori threshold for statistical significance is <0.05|Regression, Linear|Robust Variance Estimation.||"This analysis was to compare the quality of life measure, Number of days physical health was not good in the past 30 days at the 12 month follow-up visit."|
1681996|NCT01221090|3093960|Superiority or Other|||||||0.68||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Followed a healthful eating plan."|
1681997|NCT01221090|3093960|Superiority or Other|||||||0.66||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat packaged foods (e.g., sweets and desserts)."|
1681998|NCT01221090|3093960|Superiority or Other||||||<|0.004||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat high-fat foods."|
1681999|NCT01221090|3093960|Superiority or Other||||||<|0.59||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Eat 5+ servings of fruits and vegetables."|
1682000|NCT01221090|3093960|Superiority or Other||||||<|0.72||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Space carbohydrates."|
1682001|NCT01221090|3093960|Superiority or Other||||||<|0.37||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Follow healthful eating plan."|
1682002|NCT01221090|3093960|Superiority or Other||||||<|0.32||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Inspect inside of shoes."|
1682003|NCT01221090|3093960|Superiority or Other||||||<|0.53||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Dry between toes."|
1682109|NCT01218243|3094246|Superiority or Other||Mean Difference (Net)|3.2|Standard Error of the Mean|0.93|<|0.01|2-Sided|95.0|1.36|5.05|||ANCOVA||||
1682004|NCT01221090|3093960|Superiority or Other||||||<|0.87||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Soak feet."|
1682005|NCT01221090|3093960|Superiority or Other||||||<|0.19||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Wash feet."|
1682006|NCT01221090|3093960|Superiority or Other||||||<|0.18||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Check feet."|
1682007|NCT01221090|3093960|Superiority or Other||||||<|0.24||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Participate in a specific exercise session."|
1682008|NCT01221090|3093960|Superiority or Other||||||<|0.53||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Exercise at least 30 minutes."|
1682009|NCT01221090|3093960|Superiority or Other||||||<|0.21||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar the recommended times."|
1682010|NCT01221090|3093960|Superiority or Other||||||<|0.26||||||A priori threshold for statistical significance is <0.05|ANOVA|||"This analysis was to compare the average difference in days for the diabetes self-care activity, Test blood sugar."|
1682011|NCT01221090|3093961|Superiority or Other|||||||0.572||||||A priori threshold for statistical significance was <0.05|Fisher Exact||||
1682012|NCT01221090|3093962|Superiority or Other|||||||0.2176||||||A priori threshold for statistical significance is <0.05|Regression, Linear|Robust variance estimates.|||
1682013|NCT01221090|3093963|Superiority or Other|||||||0.771||||||A priori threshold for statistical significance is <0.05|Likelihood Ratio Tests|||We used a multilevel statistical model including time (in days) as a continuous variable, where 0=baseline. The lowest level of the hierarchy was repeated measurements of HbA1c on each subject, with participants themselves constituting the 2nd level. Forward selection was utilized, in which powers of time were added one at a time to the base model including treatment group effects. Interaction terms between time & treatment effects were added gradually and evaluated with likelihood ratio tests.|
1682014|NCT01220973|3093978|Other||Slope|0.74|||||2-Sided||||||||||
1682015|NCT01220180|3094030|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1682016|NCT01220180|3094031|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1682017|NCT01220180|3094032|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1682018|NCT01220180|3094033|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1682019|NCT01220180|3094034|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1682020|NCT01220180|3094035|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1682021|NCT01220180|3094036|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1682022|NCT01220180|3094037|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1682023|NCT01219985|3094070|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||The null hypothesis was : lesions' SUVmax are equivalent with our without application of the CT-Based respiratory-gated PET method.|
1682024|NCT01219985|3094071|Superiority or Other||||||<|0.001|||||||McNemar|||We performed a McNemar test to compare the sensitivities obtained for each PET image method|
1682025|NCT01219959|3094072|Superiority||Mean Difference (Final Values)|-0.2||||0.955|2-Sided|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6|
1682026|NCT01219959|3094073|Superiority||Mean Difference (Final Values)|2.4||||0.82|2-Sided|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6|
1682027|NCT01219959|3094073|Superiority||Mean Difference (Final Values)|2.3||||0.832|2-Sided|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6|
1682028|NCT01219959|3094074|Superiority||Mean Difference (Final Values)|7.8||||0.486|2-Sided|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6|
1682029|NCT01219959|3094074|Superiority||Mean Difference (Final Values)|6.3||||0.626|2-Sided|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6|
1682030|NCT01219959|3094075|Superiority||Mean Difference (Final Values)|55.4||||0.081|2-Sided|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6|
1682031|NCT01219959|3094075|Superiority||Mean Difference (Final Values)|24.6||||0.495|2-Sided|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6|
1682032|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|2.38||||0.34|2-Sided|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6|
1682033|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|-0.09||||0.97|2-Sided|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3|
1682034|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|-0.33||||0.906|2-Sided|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6|
1682035|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|-1.5||||0.586|2-Sided|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3|
1682036|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|1.62||||0.641|2-Sided|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6|
1682037|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|1.89||||0.585|2-Sided|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3|
1682038|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|3.13||||0.209|2-Sided|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6|
1682039|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|0.2||||0.934|2-Sided|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3|
1682040|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|7.21||||0.01|2-Sided|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6|
1682041|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|1.07||||0.701|2-Sided|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3|
1682042|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|4.41||||0.128|2-Sided|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6|
1682043|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|0.41||||0.885|2-Sided|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3|
1682044|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|-0.72||||0.78|2-Sided|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6|
1682045|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|-2.95||||0.246|2-Sided|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3|
1682046|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|0.83||||0.779|2-Sided|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6|
1682047|NCT01219959|3094076|Superiority||Mean Difference (Final Values)|-1.87||||0.526|2-Sided|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3|
1682048|NCT01219959|3094077|Superiority||Mean Difference (Final Values)|0.02||||0.995|2-Sided|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6|
1682049|NCT01219959|3094077|Superiority||Mean Difference (Final Values)|2.18||||0.525|2-Sided|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3|
1682050|NCT01219959|3094078|Superiority||Mean Difference (Final Values)|-0.02||||0.485|2-Sided|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6|
1682051|NCT01219959|3094078|Superiority||Mean Difference (Final Values)|0.02||||0.412|2-Sided|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3|
1682052|NCT01219959|3094079|Superiority||Mean Difference (Final Values)|-18.3||||0.854|2-Sided|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6|
1682053|NCT01219959|3094079|Superiority||Mean Difference (Final Values)|185.3||||0.377|2-Sided|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3|
1682054|NCT01219959|3094079|Superiority||Mean Difference (Final Values)|-1.7||||0.731|2-Sided|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6|
1682055|NCT01219959|3094079|Superiority||Mean Difference (Final Values)|5.2||||0.608|2-Sided|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3|
1682056|NCT01219959|3094080|Superiority||Mean Difference (Final Values)|-0.3||||0.871|2-Sided|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6|
1682057|NCT01219959|3094081|Superiority||Mean Difference (Final Values)|0.3||||0.581|2-Sided|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6|
1682058|NCT01219959|3094081|Superiority||Mean Difference (Final Values)|0.0||||0.961|2-Sided|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3|
1682059|NCT01219959|3094082|Superiority||Mean Difference (Final Values)|0.7||||0.716|2-Sided|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6|
1682060|NCT01219959|3094082|Superiority||Mean Difference (Final Values)|-0.3||||0.884|2-Sided|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3|
1682061|NCT01219959|3094083|Superiority||Mean Difference (Final Values)|3.0||||0.019|2-Sided|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6|
1682062|NCT01219959|3094083|Superiority||Mean Difference (Final Values)|3.2||||0.019|2-Sided|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3|
1682063|NCT01219959|3094084|Superiority||Mean Difference (Final Values)|-0.2|||<|0.001|2-Sided|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6|
1682064|NCT01219959|3094084|Superiority||Mean Difference (Final Values)|-0.2|||<|0.012|2-Sided|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3|
1682065|NCT01219959|3094084|Superiority||Mean Difference (Final Values)|-10.3|||<|0.001|2-Sided|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6|
1682066|NCT01219959|3094084|Superiority||Mean Difference (Final Values)|-10.2|||<|0.127|2-Sided|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3|
1682067|NCT01219959|3094085|Superiority||Mean Difference (Final Values)|1.4||||0.091|2-Sided|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6|
1682068|NCT01219959|3094085|Superiority||Mean Difference (Final Values)|-0.2||||0.817|2-Sided|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3|
1682069|NCT01219959|3094085|Superiority||Mean Difference (Final Values)|1.3||||0.029|2-Sided|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6|
1682070|NCT01219959|3094085|Superiority||Mean Difference (Final Values)|0.6||||0.338|2-Sided|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3|
1682071|NCT01219959|3094086|Superiority||Mean Difference (Final Values)|0.89||||0.624|2-Sided|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6|
1682072|NCT01219959|3094087|Superiority||Mean Difference (Final Values)|13.5||||0.247|2-Sided|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6|
1682073|NCT01219959|3094087|Superiority||Mean Difference (Final Values)|-4.2||||0.721|2-Sided|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3|
1682074|NCT01219959|3094088|Superiority||Mean Difference (Final Values)|121.8||||0.82|2-Sided|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6|
1682075|NCT01219959|3094088|Superiority||Mean Difference (Final Values)|441.3||||0.419|2-Sided|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3|
1682076|NCT01219959|3094088|Superiority||Mean Difference (Final Values)|-29.2||||0.811|2-Sided|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6|
1682077|NCT01219959|3094088|Superiority||Mean Difference (Final Values)|-56.5||||0.655|2-Sided|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3|
1682078|NCT01219959|3094089|Superiority||Mean Difference (Final Values)|8.4||||0.03|2-Sided|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6|
1682079|NCT01219959|3094089|Superiority||Mean Difference (Final Values)|11.4||||0.004|2-Sided|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3|
1682080|NCT01219959|3094089|Superiority||Mean Difference (Final Values)|5.0||||0.134|2-Sided|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6|
1682081|NCT01219959|3094089|Superiority||Mean Difference (Final Values)|5.6||||0.101|2-Sided|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3|
1682082|NCT01219959|3094089|Superiority||Mean Difference (Final Values)|-1.9||||0.556|2-Sided|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6|
1682083|NCT01219959|3094089|Superiority||Mean Difference (Final Values)|-2.3||||0.485|2-Sided|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3|
1682084|NCT01219959|3094090|Superiority||Mean Difference (Final Values)|0.7||||0.002|2-Sided|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6|
1682085|NCT01219959|3094090|Superiority||Mean Difference (Final Values)|0.8|||<|0.001|2-Sided|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3|
1682086|NCT01219959|3094090|Superiority||Mean Difference (Final Values)|0.3|||<|0.003|2-Sided|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6|
1682087|NCT01219959|3094090|Superiority||Mean Difference (Final Values)|0.4|||<|0.001|2-Sided|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3|
1682088|NCT01219959|3094090|Superiority||Mean Difference (Final Values)|0.0|||<|0.298|2-Sided|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6|
1682089|NCT01219959|3094090|Superiority||Mean Difference (Final Values)|-0.1|||<|0.198|2-Sided|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3|
1682090|NCT01219959|3094090|Superiority||Mean Difference (Final Values)|0.1|||<|0.593|2-Sided|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6|
1682091|NCT01219959|3094090|Superiority||Mean Difference (Final Values)|0.2|||<|0.181|2-Sided|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3|
1682092|NCT01219959|3094090|Superiority||Median Difference (Final Values)|0.3|||<|0.073|2-Sided|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6|
1682093|NCT01219959|3094090|Superiority||Mean Difference (Final Values)|0.5|||<|0.01|2-Sided|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3|
1682094|NCT01219959|3094092|Superiority||Mean Difference (Final Values)|4.7||||0.342|2-Sided|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6|
1682095|NCT01219959|3094092|Superiority||Mean Difference (Final Values)|5.0||||0.312|2-Sided|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3|
1682096|NCT01219959|3094093|Superiority||Mean Difference (Final Values)|0.5||||0.006|2-Sided|95.0|0.1|0.8|||ANOVA|||Month 6|
1682097|NCT01219959|3094093|Superiority||Mean Difference (Final Values)|0.6|||<|0.001|2-Sided|95.0|0.2|0.9|||ANOVA|||Month 3|
1682098|NCT01219855|3094131|Superiority or Other||||||<|0.001|||||||Z-test compared 2 independ. proportions|||The proportion of subjects achieving a ≥20% decrease in plasma iPTH at EOT was greater in the CTAP101 Capsules 60 and 90 μg groups compared to the corresponding placebo group.|
1682099|NCT01219855|3094132|Superiority or Other||||||<|0.05|||||||Z-test compared 2 independ. proportions||||
1682100|NCT01219855|3094133|Superiority or Other||||||<|0.0001|||||||Mixed effect model||||
1682101|NCT01219855|3094134|Superiority or Other||||||<|0.01|||||||Mixed effect model||||
1682102|NCT01219855|3094134|Superiority or Other||||||<|0.0001|||||||Mixed effect model||||
1682103|NCT01219855|3094135|Superiority or Other||||||<|0.01|||||||Mixed effect model||||
1682104|NCT01219855|3094136|Superiority or Other||||||<|0.0001|||||||Z-test cmpared 2 independ. proportions||||
1682105|NCT01218958|3094146|Superiority or Other||Hazard Ratio (HR)|0.83||||0.0744|2-Sided|95.0|0.677|1.018|||Andersen-Gill recurrent-event Cox model||||
1682106|NCT01218958|3094146|Superiority or Other||Hazard Ratio (HR)|0.751||||0.0245|2-Sided|95.0|0.6|0.94||The Hochberg method was used to adjust P-value for multiple comparisons (ie, 380 mg dose vs. placebo and 190 mg dose vs. placebo).|Andersen-Gill recurrent-event Cox|||"The event rate (percentage) is represented by the number of heavy drinking days divided by number of days at risk. For each day, the active groups' results were contrasted with placebo to form the event rate ratio. Thus, a hazard ratio of 0.75 for the 380 mg group indicates a 25% reduction in heavy drinking compared with that of placebo.~The method of analysis estimates the average ratio over time and accounts for discontinuation. Point/interval estimates for pairwise ratios were derived."|
1682107|NCT01218438|3094223|Superiority or Other||Poisson|0.012|||<|0.0001|1-Sided|99.0||0.024|||Poisson||||
1682108|NCT01218243|3094245|Superiority or Other||Mean Difference (Net)|4.12|Standard Error of the Mean|1.03|<|0.01|2-Sided|95.0|2.07|6.18|||ANCOVA||||
1682110|NCT01218243|3094247|Superiority or Other||Mean Difference (Net)|0.184|Standard Error of the Mean|0.8|>|0.05|2-Sided|95.0|-1.41|1.78|||ANCOVA||||
1682111|NCT01218243|3094248|Superiority or Other||Mean Difference (Net)|3.34|Standard Error of the Mean|6.6|>|0.05|2-Sided|95.0|-9.76|16.44|||Wilcoxon (Mann-Whitney)||||
1682112|NCT01218243|3094249|Superiority or Other||Mean Difference (Net)|4.51|Standard Error of the Mean|0.93|<|0.01|2-Sided|95.0|2.67|6.36|||ANCOVA||||
1682113|NCT01218204|3094257|Superiority or Other||Mean Difference (Net)|-0.884|||||2-Sided|95.0|-1.3652|-0.4026|||||Statistical analysis was performed using LS mean value of GSK1292263||
1682114|NCT01218204|3094257|Superiority or Other||Mean Difference (Net)|-0.782|||||2-Sided|95.0|-1.2804|-0.2844|||||Statistical analysis was performed using LS mean value of GSK1292263||
1682115|NCT01218204|3094257|Superiority or Other||Mean Difference (Net)|-0.648|||||2-Sided|95.0|-1.1657|-0.1302|||||Statistical analysis was performed using LS mean value of GSK1292263||
1682116|NCT01218204|3094257|Superiority or Other||Mean Difference (Net)|-0.384|||||2-Sided|95.0|-0.6009|-0.1669|||||Statistical analysis was performed using LS mean value of Atorvastatin||
1682117|NCT01218204|3094257|Superiority or Other||Mean Difference (Net)|-0.422|||||2-Sided|95.0|-0.9831|0.1394|||||Statistical analysis was performed using LS mean value of Atorvastatin||
1682118|NCT01218204|3094257|Superiority or Other||Mean Difference (Net)|-0.811|||||2-Sided|95.0|-1.4125|-0.2098|||||Statistical analysis was performed using LS mean value of Atorvastatin||
1682119|NCT01218204|3094257|Superiority or Other||Mean Difference (Net)|-0.296|||||2-Sided|95.0|-0.9063|0.3141|||||Statistical analysis was performed using LS mean value of Atorvastatin||
1682120|NCT01218204|3094257|Superiority or Other||Mean Difference (Net)|-0.409|||||2-Sided|95.0|-1.0123|0.1942|||||Statistical analysis was performed using LS mean value of Atorvastatin||
1682121|NCT01218204|3094258|Superiority or Other||Mean Difference (Net)|-35.735|||||2-Sided|95.0|-49.722|-21.7485|||||Statistical analysis was performed using LS mean value of GSK1292263||
1682122|NCT01218204|3094258|Superiority or Other||Mean Difference (Net)|-21.903|||||2-Sided|95.0|-36.6155|-7.1913|||||Statistical analysis was performed using LS mean value of GSK1292263||
1682123|NCT01218204|3094258|Superiority or Other||Mean Difference (Net)|-20.042|||||2-Sided|95.0|-34.8358|-5.2472|||||Statistical analysis was performed using LS mean value of GSK1292263||
1682124|NCT01218204|3094258|Superiority or Other||Mean Difference (Net)|-29.293|||||2-Sided|95.0|-51.5654|-12.4042|||||Statistical analysis was performed using LS mean value of Atorvastatin||
1682125|NCT01218204|3094258|Superiority or Other||Mean Difference (Net)|-28.041|||||2-Sided|95.0|-42.2554|-13.8263|||||Statistical analysis was performed using LS mean value of Atorvastatin||
1682126|NCT01218204|3094258|Superiority or Other||Mean Difference (Net)|-41.506|||||2-Sided|95.0|-56.3924|-26.6205|||||Statistical analysis was performed using LS mean value of Atorvastatin||
1682127|NCT01218204|3094258|Superiority or Other||Mean Difference (Net)|-21.63|||||2-Sided|95.0|-35.9419|-7.3181|||||Statistical analysis was performed using LS mean value of Atorvastatin||
1682128|NCT01218204|3094258|Superiority or Other||Mean Difference (Net)|-12.123|||||2-Sided|95.0|-26.6276|2.3814|||||Statistical analysis was performed using LS mean value of Atorvastatin||
1682129|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-16.728|||||2-Sided|95.0|-23.8395|-9.6161||||||For Cholesterol|
1682130|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-15.7|||||2-Sided|95.0|-23.1404|-8.2592|||||Statistical analysis was performed using LS mean value of GSK1292263|For Cholesterol|
1682131|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-8.384|||||2-Sided|95.0|-15.9023|-0.866|||||Statistical analysis was performed using LS mean value of GSK1292263|For Cholesterol|
1682132|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-7.941|||||2-Sided|95.0|-13.9778|-1.9039|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol|
1682133|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-12.065|||||2-Sided|95.0|-19.7688|-4.3609|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol|
1682134|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-10.294|||||2-Sided|95.0|-18.3923|-2.196|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol|
1682135|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-6.437|||||2-Sided|95.0|-14.346|1.4722|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol|
1682136|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-3.904|||||2-Sided|95.0|-11.8484|4.04|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Cholesterol|
1682137|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-26.948|||||2-Sided|95.0|-36.2874|-17.6092|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc|
1682138|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-22.151|||||2-Sided|95.0|-31.942|-12.3605|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc|
1682139|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-13.18|||||2-Sided|95.0|-23.0636|-3.2961|||||Statistical analysis was performed using LS mean value of GSK1292263|For Non-HDLc|
1682140|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-21.702|||||2-Sided|95.0|-29.0346|-14.3696|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc|
1682141|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-20.937|||||2-Sided|95.0|-32.6057|-9.269|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc|
1682142|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-27.675|||||2-Sided|95.0|-39.8454|-15.5045|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc|
1682143|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-14.014|||||2-Sided|95.0|-25.7497|-2.2787|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc|
1682144|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-9.756|||||2-Sided|95.0|-21.7561|2.2448|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Non-HDLc|
1682145|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-54.843|||||2-Sided|95.0|-70.7854|-38.9007|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides|
1682146|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-46.361|||||2-Sided|95.0|-63.465|-29.2561|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides|
1682147|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-21.421|||||2-Sided|95.0|-38.3519|-4.4911|||||Statistical analysis was performed using LS mean value of GSK1292263|For Triglycerides|
1682148|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-21.781|||||2-Sided|95.0|-40.296|-3.2667|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides|
1682149|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-17.444|||||2-Sided|95.0|-33.502|2.491|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides|
1682150|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-39.923|||||2-Sided|95.0|-52.3394|-24.2717|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides|
1682151|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-23.781|||||2-Sided|95.0|-39.1603|-4.513|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides|
1682152|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-22.498|||||2-Sided|95.0|-38.446|-2.4169|||||Statistical analysis was performed using LS mean value of Atorvastatin|For Triglycerides|
1682153|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-21.789|||||2-Sided|95.0|-32.3413|-11.2372|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc|
1682154|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-15.798|||||2-Sided|95.0|-27.1364|-4.4589|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc|
1682155|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-12.128|||||2-Sided|95.0|-23.3049|-0.9514|||||Statistical analysis was performed using LS mean value of GSK1292263|For LDLc|
1682156|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-25.472|||||2-Sided|95.0|-49.3385|-8.1558|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc|
1682157|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-20.173|||||2-Sided|95.0|-34.271|-6.0755|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc|
1682158|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-21.317|||||2-Sided|95.0|-36.0144|-6.619|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc|
1682159|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-10.337|||||2-Sided|95.0|-24.4549|3.7803|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc|
1682160|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|-4.549|||||2-Sided|95.0|-18.775|9.6768|||||Statistical analysis was performed using LS mean value of Atorvastatin|For LDLc|
1682161|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|20.689|||||2-Sided|95.0|9.7527|31.6262|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc|
1682162|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|11.122|||||2-Sided|95.0|-0.2902|22.5351|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc|
1682163|NCT01218204|3094259|Superiority or Other||Median Difference (Net)|10.561|||||2-Sided|95.0|-0.9675|22.0898|||||Statistical analysis was performed using LS mean value of GSK1292263|For HDLc|
1682164|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|20.946|||||2-Sided|95.0|8.612|33.281|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc|
1682165|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|3.701|||||2-Sided|95.0|-5.5562|12.9578|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc|
1682166|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|28.833|||||2-Sided|95.0|18.955|38.7102|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc|
1682167|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|12.273|||||2-Sided|95.0|2.5937|21.9532|||||Statistical analysis was performed using LS mean value of Atorvastatin|Fo HDLc|
1682168|NCT01218204|3094259|Superiority or Other||Mean Difference (Net)|5.101|||||2-Sided|95.0|-4.5469|14.7495|||||Statistical analysis was performed using LS mean value of Atorvastatin|For HDLc|
1682169|NCT01218204|3094260|Superiority or Other||Mean Difference (Net)|-32.798|||||2-Sided|95.0|-48.3842|-12.5064|||||Statistical analysis was performed using LS mean value of GSK1292263||
1682170|NCT01218204|3094260|Superiority or Other||Mean Difference (Net)|-22.117|||||2-Sided|95.0|-40.4767|1.906|||||Statistical analysis was performed using LS mean value of GSK1292263||
1682171|NCT01218204|3094260|Superiority or Other||Mean Difference (Net)|0.198|||||2-Sided|95.0|-24.2901|32.6057|||||Statistical analysis was performed using LS mean value of GSK1292263||
1682172|NCT01218204|3094260|Superiority or Other||Mean Difference (Net)|-6.036|||||2-Sided|95.0|-27.2281|15.1569|||||Statistical analysis was performed using LS mean value of Atorvastatin||
1682173|NCT01218204|3094260|Superiority or Other||Mean Difference (Net)|-16.697|||||2-Sided|95.0|-45.0846|13.3024|||||Statistical analysis was performed using LS mean value Atorvastatin||
1682174|NCT01218204|3094260|Superiority or Other||Mean Difference (Net)|-25.985|||||2-Sided|95.0|-45.5492|1.8605|||||Statistical analysis was performed using LS mean value Atorvastatin||
1682175|NCT01218204|3094260|Superiority or Other||Mean Difference (Net)|-5.91|||||2-Sided|95.0|-38.1027|25.3126|||||Statistical analysis was performed using LS mean value Atorvastatin||
1682176|NCT01218204|3094260|Superiority or Other||Mean Difference (Net)|-19.471|||||2-Sided|95.0|-47.9323|3.202|||||Statistical analysis was performed using LS mean value Atorvastatin||
1682177|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|-9.687|||||2-Sided|95.0|-26.0247|6.6498|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 800 mg vs Placebo: Apolipoprotein B100|
1682178|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|-8.49|||||2-Sided|95.0|-25.2721|8.2918|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 300 mg vs Placebo: Apolipoprotein B100|
1682179|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|-6.1|||||2-Sided|95.0|-23.5021|11.3014|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 100 mg vs Placebo: Apolipoprotein B100|
1682180|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|-28.231|||||2-Sided|95.0|-45.1045|-11.3579|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100|
1682181|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|-2.903|||||2-Sided|95.0|-16.6557|13.1191|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein B100|
1682842|NCT01215175|3094809|Other||Risk Difference (RD)|10.0||||||95.0|-7.4|28.3|||||Miettinen & Nurminen method||
1682182|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|-13.96|||||2-Sided|95.0|-26.8137|1.1513|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100|
1682183|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|-7.428|||||2-Sided|95.0|-21.3243|8.9224|||||Statistical analysis was performed using LS mean value Atorvastatin|Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein B100|
1682184|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|13.743|||||2-Sided|95.0|-3.246|33.7161|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein B100|
1682185|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|-2.466|||||2-Sided|95.0|-23.7517|24.7608|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 800 mg vs Placebo: Apolipoprotein A1|
1682186|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|1.934|||||2-Sided|95.0|-21.0153|31.5504|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 300 mg vs Placebo: Apolipoprotein A1|
1682187|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|7.713|||||2-Sided|95.0|-17.0405|39.8527|||||Statistical analysis was performed using LS mean value of GSK1292263|GSK1292263 100 mg vs Placebo: Apolipoprotein A1|
1682188|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|4.618|||||2-Sided|95.0|-28.2069|37.4425|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1|
1682189|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|3.671|||||2-Sided|95.0|-16.9957|24.3384|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein A1|
1682190|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|11.906|||||2-Sided|95.0|-9.3489|33.1602|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1|
1682191|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|-0.598|||||2-Sided|95.0|-21.784|20.5888|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein A1|
1682192|NCT01218204|3094261|Superiority or Other||Mean Difference (Net)|5.473|||||2-Sided|95.0|-15.7096|26.6553|||||Statistical analysis was performed using LS mean value of Atorvastatin|Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein A1|
1682193|NCT01218126|3094298|Superiority or Other||Rate ratio|0.74||||0.21|2-Sided|95.0|0.47|1.18|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 15 mg arm) / (Rate of exacerbation in placebo arm)|Placebo versus Losmapimod 15 mg|
1682194|NCT01218126|3094298|Superiority or Other||Rate ratio|0.98||||0.915||95.0|0.64|1.5|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 7.5 mg arm) / (Rate of exacerbation in placebo arm)|Placebo versus Losmapimod 7.5 mg|
1682195|NCT01218126|3094298|Superiority or Other||Rate ratio|1.0||||0.989|2-Sided|95.0|0.64|1.54|||Negative Binomial regression model|Covariates of treatment, group, smoking status, history of exacerbations and region, with logarithm of time on treatment as an offset variable.|Rate ratio= (Rate of exacerbation in Losmapimod 2.5 mg arm) / (Rate of exacerbation in placebo arm)|Losmapimod 2.5 mg versus Placebo|
1682196|NCT01218126|3094299|Superiority or Other||Mean Difference (Net)|0.86||||0.256|2-Sided|95.0|0.67|1.11|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24|
1682197|NCT01218126|3094299|Superiority or Other||Mean Difference (Net)|0.81||||0.099|2-Sided|95.0|0.64|1.04|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24|
1682198|NCT01218126|3094299|Superiority or Other||Mean Difference (Net)|0.95||||0.696|2-Sided|95.0|0.74|1.22|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24|
1682199|NCT01218126|3094299|Superiority or Other||Mean Difference (Net)|0.64||||0|2-Sided|95.0|0.5|0.82|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12|
1682200|NCT01218126|3094299|Superiority or Other||Mean Difference (Net)|0.73||||0.011||95.0|0.57|0.93|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12|
1682201|NCT01218126|3094299|Superiority or Other||Mean Difference (Net)|0.91||||0.468|2-Sided|95.0|0.71|1.17|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12|
1682202|NCT01218126|3094299|Superiority or Other||Mean Difference (Net)|0.74||||0.015|2-Sided|95.0|0.58|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8|
1682203|NCT01218126|3094299|Superiority or Other||Mean Difference (Net)|0.77||||0.029|2-Sided|95.0|0.6|0.97|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8|
1682204|NCT01218126|3094299|Superiority or Other||Mean Difference (Net)|1.04||||0.755|2-Sided|95.0|0.82|1.32|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 8|
1682205|NCT01218126|3094299|Superiority or Other||Mean Difference (Net)|0.73||||0.014|2-Sided|95.0|0.57|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4|
1682206|NCT01218126|3094299|Superiority or Other||Mean Difference (Net)|0.78||||0.046|2-Sided|95.0|0.61|1.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4|
1682207|NCT01218126|3094299|Superiority or Other||Mean Difference (Net)|0.87||||0.291|2-Sided|95.0|0.68|1.12|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4|
1682208|NCT01218126|3094300|Superiority or Other||Mean Difference (Net)|0.95||||0.126|2-Sided|95.0|0.9|1.01|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24|
1682209|NCT01218126|3094300|Superiority or Other||Mean Difference (Net)|0.96||||0.153|2-Sided|95.0|0.9|1.02|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24|
1682210|NCT01218126|3094300|Superiority or Other||Mean Difference (Net)|1.01||||0.823|2-Sided|95.0|0.95|1.07|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24|
1682211|NCT01218126|3094300|Superiority or Other||Mean Difference (Net)|0.9||||0.001|2-Sided|95.0|0.84|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12|
1682212|NCT01218126|3094300|Superiority or Other||Mean Difference (Net)|0.91||||0.002|2-Sided|95.0|0.86|0.97|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12|
1682213|NCT01218126|3094300|Superiority or Other||Mean Difference (Net)|0.99||||0.728|2-Sided|95.0|0.93|1.05|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12|
1682214|NCT01218126|3094300|Superiority or Other||Mean Difference (Net)|0.88||||0|2-Sided|95.0|0.83|0.94|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 8|
1682215|NCT01218126|3094300|Superiority or Other||Mean Difference (Net)|0.9||||0|2-Sided|95.0|0.85|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 8|
1682216|NCT01218126|3094300|Superiority or Other||Mean Difference (Net)|0.95||||0.072||95.0|0.9|1.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 8|
1682217|NCT01218126|3094300|Superiority or Other||Mean Difference (Net)|0.91||||0|2-Sided|95.0|0.86|0.96|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4|
1682218|NCT01218126|3094300|Superiority or Other||Mean Difference (Net)|0.91||||0|2-Sided|95.0|0.86|0.95|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4|
1682219|NCT01218126|3094300|Superiority or Other||Mean Difference (Net)|0.96||||0.157|2-Sided|95.0|0.91|1.01|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4|
1682220|NCT01218126|3094302|Superiority or Other||Mean Difference (Net)|-1.4||||0.39|2-Sided|95.0|-4.5|1.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24|
1682221|NCT01218126|3094302|Superiority or Other||Mean Difference (Net)|1.9||||0.229|2-Sided|95.0|-1.2|5.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24|
1682222|NCT01218126|3094302|Superiority or Other||Mean Difference (Net)|0.4||||0.803|2-Sided|95.0|-2.7|3.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24|
1682223|NCT01218126|3094302|Superiority or Other||Mean Difference (Net)|-1.8||||0.193|2-Sided|95.0|-4.6|0.9|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12|
1682224|NCT01218126|3094302|Superiority or Other||Mean Difference (Net)|1.5||||0.279|2-Sided|95.0|-1.2|4.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12|
1682225|NCT01218126|3094302|Superiority or Other||Mean Difference (Net)|-0.6||||0.686|2-Sided|95.0|-3.3|2.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12|
1682226|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|35.0||||0.434|2-Sided|95.0|-53.0|124.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 24|
1682227|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|10.0||||0.827|2-Sided|95.0|-77.0|96.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 24|
1682228|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|-28.0||||0.53|2-Sided|95.0|-115.0|59.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 24|
1682229|NCT01218126|3094303|Superiority or Other||Mean Difference (Final Values)|49.0||||0.275||95.0|-39.0|138.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 20|
1682230|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|-12.0||||0.792|2-Sided|95.0|-98.0|75.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 20|
1682231|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|-64.0||||0.147||95.0|-151.0|23.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 20|
1682232|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|72.0||||0.108|2-Sided|95.0|-16.0|159.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 16|
1682233|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|17.0||||0.704|2-Sided|95.0|-69.0|103.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 16|
1682234|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|-31.0||||0.485|2-Sided|95.0|-118.0|56.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 16|
1682235|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|75.0||||0.096|2-Sided|95.0|-13.0|163.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 12|
1682236|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|13.0||||0.763|2-Sided|95.0|-73.0|100.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 12|
1682237|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|-11.0||||0.805|2-Sided|95.0|-98.0|76.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 12|
1682238|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|66.0||||0.116|2-Sided|95.0|-16.0|149.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 8|
1682917|NCT01214720|3094911|Superiority or Other||Hazard Ratio (HR)|0.73||||0.0002|2-Sided|95.0|0.61|0.86|||Log Rank||||
1682239|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|-30.0||||0.472|2-Sided|95.0|-110.0|51.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 8|
1682240|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|-25.0||||0.554|2-Sided|95.0|-107.0|57.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 8|
1682241|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|71.0||||0.056|2-Sided|95.0|-1.8|143.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 4|
1682242|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|12.0||||0.741|2-Sided|95.0|-60.0|84.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 4|
1682243|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|8.0||||0.839|2-Sided|95.0|-65.0|80.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 4|
1682244|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|43.0||||0.355|2-Sided|95.0|-48.0|134.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 24|
1682245|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|-7.0||||0.872|2-Sided|95.0|-97.0|82.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 24|
1682246|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|-24.0||||0.604||95.0|-113.0|66.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 24|
1682247|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|32.0||||0.486|2-Sided|95.0|-59.0|123.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 20|
1682248|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|6.0||||0.887|2-Sided|95.0|-82.0|95.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 20|
1682249|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|-32.0||||0.487|2-Sided|95.0|-121.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 20|
1682250|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|42.0||||0.369|2-Sided|95.0|-49.0|133.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 16|
1682251|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|25.0||||0.579|2-Sided|95.0|-64.0|114.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 16|
1682252|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|10.0||||0.832|2-Sided|95.0|-80.0|100.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 16|
1682253|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|75.0||||0.098|2-Sided|95.0|-14.0|163.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 12|
1682254|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|16.0||||0.716|2-Sided|95.0|-71.0|103.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 12|
1682255|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|45.0||||0.319|2-Sided|95.0|-43.0|132.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 12|
1682256|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|47.0||||0.277|2-Sided|95.0|-38.0|131.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 8|
1682257|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|-12.0||||0.773||95.0|-95.0|70.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 8|
1682258|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|-9.0||||0.826|2-Sided|95.0|-93.0|74.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 8|
1682259|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|57.0||||0.157|2-Sided|95.0|-22.0|137.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 15 mg at Week 4|
1682260|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|-30.0||||0.446|2-Sided|95.0|-109.0|48.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 7.5 mg at Week 4|
1682261|NCT01218126|3094303|Superiority or Other||Mean Difference (Net)|13.0||||0.742|2-Sided|95.0|-66.0|93.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FVC for Placebo versus Losmapimod 2.5 mg at Week 4|
1682262|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|6.0||||0.781|2-Sided|95.0|-38.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 24|
1682263|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|20.0||||0.355|2-Sided|95.0|-23.0|64.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 24|
1682264|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|-9.0||||0.671|2-Sided|95.0|-53.0|34.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 24|
1682265|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|14.0||||0.526|2-Sided|95.0|-30.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 20|
1682266|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|27.0||||0.214|2-Sided|95.0|-16.0|70.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 20|
1682267|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|-19.0||||0.398|2-Sided|95.0|-62.0|25.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 20|
1682268|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|26.0||||0.243|2-Sided|95.0|-18.0|69.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 16|
1682269|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|19.0||||0.387|2-Sided|95.0|-24.0|61.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 16|
1682270|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|-6.0||||0.772|2-Sided|95.0|-49.0|37.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 16|
1682271|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|38.0||||0.094|2-Sided|95.0|-6.5|83.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 12|
1682272|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|11.0||||0.636|2-Sided|95.0|-33.0|54.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 12|
1682273|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|-9.0||||0.678|2-Sided|95.0|-53.0|35.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 12|
1682274|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|43.0||||0.06||95.0|-1.7|87.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 8|
1682275|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|7.0||||0.766|2-Sided|95.0|-37.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 8|
1682276|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|-1.0||||0.958|2-Sided|95.0|-45.0|43.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 8|
1682277|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|31.0||||0.089|2-Sided|95.0|-4.8|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 4|
1682278|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|16.0||||0.386|2-Sided|95.0|-20.0|51.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 4|
1682279|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|4.0||||0.807|2-Sided|95.0|-31.0|40.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Post-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 4|
1682280|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|15.0||||0.494|2-Sided|95.0|-28.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 24|
1682281|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|18.0||||0.397|2-Sided|95.0|-24.0|60.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 24|
1682282|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|4.0||||0.852|2-Sided|95.0|-38.0|46.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 24|
1682283|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|29.0||||0.191|2-Sided|95.0|-15.0|74.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 20|
1682284|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|33.0||||0.134|2-Sided|95.0|-10.0|76.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 20|
1682285|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|6.0||||0.786|2-Sided|95.0|-37.0|49.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 20|
1682286|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|24.0||||0.289|2-Sided|95.0|-20.0|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 16|
1682287|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|24.0||||0.267|2-Sided|95.0|-19.0|67.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 16|
1682288|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|22.0||||0.32|2-Sided|95.0|-21.0|65.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 16|
1682289|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|49.0||||0.023|2-Sided|95.0|6.7|91.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 12|
1682290|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|20.0||||0.355|2-Sided|95.0|-22.0|61.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 12|
1682291|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|16.0||||0.456|2-Sided|95.0|-26.0|58.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 12|
1682292|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|37.0||||0.094|2-Sided|95.0|-6.3|79.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 8|
1682293|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|8.0||||0.694|2-Sided|95.0|-34.0|50.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 7.5 mg at Week 8|
1682294|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|-2.0||||0.922|2-Sided|95.0|-45.0|40.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 8|
1682295|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|28.0||||0.152|2-Sided|95.0|-10.0|66.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 15 mg at Week 4|
1682296|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|-7.0||||0.715|2-Sided|95.0|-45.0|31.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 Placebo versus Losmapimod 7.5 mg at Week 4|
1682297|NCT01218126|3094304|Superiority or Other||Mean Difference (Net)|-1.0||||0.968|2-Sided|95.0|-39.0|38.0|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Pre-Bronchodilator FEV1 for Placebo versus Losmapimod 2.5 mg at Week 4|
1682298|NCT01218126|3094305|Superiority or Other||Mean Difference (Net)|-3.4||||0.564|2-Sided|95.0|-15.1|8.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 24|
1682299|NCT01218126|3094305|Superiority or Other||Mean Difference (Net)|-4.7||||0.422|2-Sided|95.0|-16.1|6.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 24|
1682300|NCT01218126|3094305|Superiority or Other||Mean Difference (Net)|-6.7||||0.26|2-Sided|95.0|-18.2|4.9|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 24|
1682301|NCT01218126|3094305|Superiority or Other||Mean Difference (Net)|1.8||||0.722|2-Sided|95.0|-8.2|11.8|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 12|
1682302|NCT01218126|3094305|Superiority or Other||Mean Difference (Net)|-1.3||||0.788|2-Sided|95.0|-11.1|8.4|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 12|
1682303|NCT01218126|3094305|Superiority or Other||Mean Difference (Net)|0.6||||0.9|2-Sided|95.0|-9.2|10.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 12|
1682304|NCT01218126|3094305|Superiority or Other||Mean Difference (Net)|5.5||||0.164|2-Sided|95.0|-2.3|13.3|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 15 mg at Week 4|
1682305|NCT01218126|3094305|Superiority or Other||Mean Difference (Net)|-1.2||||0.763|2-Sided|95.0|-8.9|6.5|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 7.5 mg at Week 4|
1682306|NCT01218126|3094305|Superiority or Other||Mean Difference (Net)|-2.6||||0.517|2-Sided|95.0|-10.4|5.2|||mixed model repeated measures||Analysis performed using a repeated measures model with covariates of treatment, region, smoking status at screening (stratum), history of exacerbations, baseline, visit, visit by baseline and visit by treatment interactions.|Placebo versus Losmapimod 2.5 mg at Week 4.|
1682918|NCT01214434|3094960|Superiority or Other||||||=|0|||||||t-test, 2 sided||||
1682919|NCT01214434|3094961|Superiority or Other||||||=|0|||||||t-test, 2 sided||||
1682307|NCT01218113|3094356|Non-Inferiority|Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D_HIV Group – Control Group) is below 0.|Mean Difference|0.073|||||2-Sided|97.5|-0.088|0.235||||||To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.|
1682308|NCT01218113|3094356|Non-Inferiority|Criterion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D_HIV Group – Control Group) is below 0.|Mean Difference|-0.096|||||2-Sided|97.5|-0.257|0.065||||||To show the difference in change from baseline of HIV-1 VL (log10-transformed values) at week 48 between persons who received 3 doses of the HIV Vaccine 732462 and persons who received placebo alone.|
1682309|NCT01218113|3094357|Non-Inferiority|Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (2D_HIV Group - Control Group) is below 0.|Geometric Mean Ratio|1.184|||||2-Sided|97.5|0.816|1.717||||||To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 2 doses of the HIV Vaccine 732462 and persons who received placebo alone.|
1682310|NCT01218113|3094357|Non-Inferiority|Crierion for non-inferiority evaluation: The upper limit (UL) of the two-sided 97.5% confidence interval (CI) for the difference in change between the two arms (3D_HIV Group - Control Group) is below 0.|Geometric Mean Ratio|0.801|||||2-Sided|97.5|0.553|1.162||||||To show the difference in change from baseline of HIV-1 VL at week 48 between persons who received 3 doses of the HIV vaccine 732462 and persons who received placebo alone.|
1682311|NCT01218087|3094361|Non-Inferiority or Equivalence|Following the first interim analysis of the first 40 infants, the sample size calculation was revised. A revised sample size of 62 infants (31 per treatment arm) was based on an observed reduction of 41% to 11% in the experimental group with a goal p value of 0.01.||||||0.03|||||||Fisher Exact||||
1682312|NCT01217892|3094410|Superiority or Other||Risk Difference (RD)|16.8|Standard Error of the Mean|6.153||0.0062|2-Sided|95.0|4.8|28.9||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|Regression, Logistic|Methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0|
1682313|NCT01217892|3094410|Superiority or Other||Risk Difference (RD)|12.2|Standard Error of the Mean|6.097||0.0455|2-Sided|95.0|0.2|24.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|Regression, Logistic|Methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0|
1682314|NCT01217892|3094411|Superiority or Other||Mean Difference (Final Values)|-15.3|Standard Error of the Mean|3.139|<|0.0001|2-Sided|95.0|-21.4|-9.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c <7.0% vs >=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)|
1682315|NCT01217892|3094411|Superiority or Other||Mean Difference (Final Values)|-10.4|Standard Error of the Mean|3.132|<|0.001|2-Sided|95.0|-16.5|-4.2||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c <7.0% vs >=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)|
1682316|NCT01217892|3094412|Superiority or Other||Mean Difference (Final Values)|-16.7|Standard Error of the Mean|3.039|<|0.0001|2-Sided|95.0|-22.7|-10.7||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c <7.0% vs >=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)|
1682317|NCT01217892|3094412|Superiority or Other||Mean Difference (Final Values)|-15.7|Standard Error of the Mean|3.04|<|0.0001|2-Sided|95.0|-21.7|-9.7||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c <7.0% vs >=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)|
1682318|NCT01217892|3094413|Superiority or Other||Mean Difference (Final Values)|-2.18|Standard Error of the Mean|0.3636|<|0.0001|2-Sided|95.0|-2.89|-1.46||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c <7.0% vs >=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)|
1682338|NCT01217112|3094470|Superiority or Other||Mean Difference (Final Values)|-0.85|Standard Error of the Mean|0.568||0.138|2-Sided|90.0|-1.81|0.1|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682319|NCT01217892|3094413|Superiority or Other||Mean Difference (Final Values)|-1.82|Standard Error of the Mean|0.363|<|0.0001|2-Sided|95.0|-2.53|-1.1||significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group for treatment groups tested significantly different from placebo for the primary endpoint.|ANCOVA|with treatment group (all treatment groups included) and stratum (HbA1c <7.0% vs >=7.0% at randomization) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05, two-sided)|
1682320|NCT01217892|3094414|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.0843|<|0.0001|2-Sided|95.0|-0.52|-0.18||significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)|
1682321|NCT01217892|3094414|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.084|<|0.0106|2-Sided|95.0|-0.38|-0.05||significant at alpha=0.05 (2-sided) applying Hochberg's method across the two Dapagliflozin BID groups.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.05 using Hochberg's method to control the overall Type I error across hypotheses in the two Dapagliflozin BID groups, two-sided)|
1682322|NCT01217801|3094432|Superiority or Other||Hazard Ratio (HR)|93.77||||0.05|2-Sided|90.0|89.15|98.63|||Regression, Linear|||Linear mixed effect model, log transformed AUC, LSMeans for treatment Film and Tablet, the difference between the LSMeans and 90%CI calculated and transformed to geometric means, ratio estimates and 90%CI|
1682323|NCT01217476|3094443|Superiority or Other||Odds Ratio (OR)|0.9|||||2-Sided|95.0|0.52|1.56|||||||
1682324|NCT01217476|3094444|Superiority or Other||Odds Ratio (OR)|1.36||||0.4039|2-Sided|95.0|0.66|2.8|||Regression, Logistic||||
1682325|NCT01217463|3094445|Superiority or Other||Odds Ratio (OR)|1.37|||||2-Sided|95.0|0.78|2.4|||||||
1682326|NCT01217463|3094446|Superiority or Other||Odds Ratio (OR)|1.44||||0.4109|2-Sided|95.0|0.6|3.43|||Regression, Logistic||||
1682327|NCT01217385|3094454|Other||Odds Ratio (OR)|2.86||||0.406|2-Sided|95.0|0.24|33.9|||Regression, Logistic||||
1682328|NCT01217385|3094454|Other||Odds Ratio (OR)|16.5||||0.043|2-Sided|95.0|1.09|250.15|||Regression, Logistic||||
1682329|NCT01217385|3094455|Equivalence|test for the equivalence of %change in TOI ratio (dichotomized at <=-40%), between PR+ and PR- groups, with interaction|Slope|0.4463|Standard Error of the Mean|1.953||0.8193|2-Sided|||||significance at alpha=0.05|Regression, Logistic|p-value represents the interaction between %TOI (dichotomized at <=-40%), and PR status|Multivariate logistic regression model using % change in TOI ratio (T/N) (baseline to mid-therapy) dichotomized at -40%, PR status, and the corresponding interaction.|The Null is that the odd ratio is the same in both the PR+ and PR- subjects fro the model including %change in TOI form baseline to mid-therapy (dichotomized at <=-40%), PR status (+/-) and the interaction between them.|
1682330|NCT01217385|3094456|Equivalence|under the NULL, it is assume that there is no difference between a 40% decrease in TOI, and a less than 40% decrease or an increase in TOI in their ability to predict pCR+|Odds Ratio (OR)|4.667||||0.059|2-Sided|95.0|0.95|23.04||5% alpha threshold for significance.|Regression, Logistic|||"This analysis will look at the ability of the % change in DOSI measured tumor Optical Index (TOI) from baseline to mid-therapy to predict pathologic response using logistic regression.~Pathologic response (dichotomized into responders and non-responders) will be used as the reference standard and %change in TOI ratio (dichotomized at -40%) will be used to estimate pCR (+/-)= alpha + beta1(%change TOI)"|
1682331|NCT01217112|3094468|Superiority or Other||Mean Difference (Final Values)|0.36|Standard Error of the Mean|1.627||0.827|2-Sided|90.0|-2.36|3.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682332|NCT01217112|3094468|Superiority or Other||Mean Difference (Final Values)|0.98|Standard Error of the Mean|1.589||0.542|2-Sided|90.0|-1.68|3.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682333|NCT01217112|3094468|Superiority or Other||Mean Difference (Final Values)|4.77|Standard Error of the Mean|1.662||0.006|2-Sided|90.0|1.99|7.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682334|NCT01217112|3094468|Superiority or Other||Mean Difference (Final Values)|0.64|Standard Error of the Mean|1.664||0.701|2-Sided|90.0|-2.14|3.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682335|NCT01217112|3094470|Superiority or Other||Mean Difference (Final Values)|0.35|Standard Error of the Mean|0.565||0.54|2-Sided|90.0|-0.6|1.29|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682336|NCT01217112|3094470|Superiority or Other||Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.54||0.743|2-Sided|90.0|-0.73|1.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682337|NCT01217112|3094470|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.547||0.505|2-Sided|90.0|-1.28|0.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682920|NCT01214434|3094962|Superiority or Other||||||=|0|||||||t-test, 2 sided||||
1682921|NCT01214434|3094963|Superiority or Other||||||=|0|||||||t-test, 2 sided||||
1682339|NCT01217112|3094471|Superiority or Other||Mean Difference (Final Values)|6.17|Standard Error of the Mean|5.71||0.285|2-Sided|90.0|-3.41|15.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682340|NCT01217112|3094471|Superiority or Other||Mean Difference (Final Values)|0.62|Standard Error of the Mean|5.103||0.904|2-Sided|90.0|-7.94|9.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682341|NCT01217112|3094471|Superiority or Other||Mean Difference (Final Values)|6.77|Standard Error of the Mean|5.519||0.226|2-Sided|90.0|-2.48|16.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682342|NCT01217112|3094471|Superiority or Other||Mean Difference (Final Values)|2.65|Standard Error of the Mean|5.38||0.625|2-Sided|90.0|-6.37|11.67|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682343|NCT01217112|3094472|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.045||0.3|2-Sided|90.0|-0.12|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682344|NCT01217112|3094472|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.048||0.128|2-Sided|90.0|-0.16|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682345|NCT01217112|3094472|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.051||0.961|2-Sided|90.0|-0.08|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682346|NCT01217112|3094472|Superiority or Other||Mean Difference (Net)|-0.07|Standard Error of the Mean|0.044||0.129|2-Sided|90.0|-0.14|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682347|NCT01217112|3094473|Superiority or Other||Mean Difference (Final Values)|4.05|Standard Error of the Mean|1.871||0.041|2-Sided|90.0|0.84|7.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682348|NCT01217112|3094473|Superiority or Other||Mean Difference (Final Values)|3.65|Standard Error of the Mean|2.016||0.084|2-Sided|90.0|0.19|7.1|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682349|NCT01217112|3094473|Superiority or Other||Mean Difference (Final Values)|6.55|Standard Error of the Mean|2.237||0.008|2-Sided|90.0|2.72|10.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682350|NCT01217112|3094473|Superiority or Other||Mean Difference (Final Values)|3.53|Standard Error of the Mean|1.814||0.064|2-Sided|90.0|0.42|6.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682351|NCT01217112|3094474|Superiority or Other||Mean Difference (Final Values)|3.54|Standard Error of the Mean|1.252||0.01|2-Sided|90.0|1.39|5.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682352|NCT01217112|3094474|Superiority or Other||Mean Difference (Final Values)|2.4|Standard Error of the Mean|1.35||0.088|2-Sided|90.0|0.09|4.72|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682353|NCT01217112|3094474|Superiority or Other||Mean Difference (Final Values)|4.71|Standard Error of the Mean|1.486||0.004|2-Sided|90.0|2.16|7.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682354|NCT01217112|3094474|Superiority or Other||Mean Difference (Final Values)|2.67|Standard Error of the Mean|1.214||0.038|2-Sided|90.0|0.59|4.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682355|NCT01217112|3094475|Superiority or Other||Mean Difference (Final Values)|0.51|Standard Error of the Mean|0.837||0.545|2-Sided|90.0|-0.92|1.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682356|NCT01217112|3094475|Superiority or Other||Mean Difference (Final Values)|1.26|Standard Error of the Mean|0.893||0.173|2-Sided|90.0|-0.28|2.79|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682357|NCT01217112|3094475|Superiority or Other||Mean Difference (Final Values)|1.74|Standard Error of the Mean|0.988||0.092|2-Sided|90.0|0.05|3.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682358|NCT01217112|3094475|Superiority or Other||Mean Difference (Final Values)|0.87|Standard Error of the Mean|0.806||0.294|2-Sided|90.0|-0.52|2.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682359|NCT01217112|3094476|Superiority or Other||Mean Difference (Final Values)|3.86|Standard Error of the Mean|1.512||0.018|2-Sided|90.0|1.26|6.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682360|NCT01217112|3094476|Superiority or Other||Mean Difference (Final Values)|3.44|Standard Error of the Mean|1.626||0.046|2-Sided|90.0|0.65|6.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682361|NCT01217112|3094476|Superiority or Other||Mean Difference (Final Values)|4.27|Standard Error of the Mean|1.798||0.026|2-Sided|90.0|1.18|7.35|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682362|NCT01217112|3094476|Superiority or Other||Mean Difference (Final Values)|3.35|Standard Error of the Mean|1.463||0.032|2-Sided|90.0|0.84|5.85|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682363|NCT01217112|3094477|Superiority or Other||Mean Difference (Final Values)|3.56|Standard Error of the Mean|1.299||0.012|2-Sided|90.0|1.33|5.78|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682364|NCT01217112|3094477|Superiority or Other||Mean Difference (Final Values)|2.85|Standard Error of the Mean|1.4||0.053|2-Sided|90.0|0.45|5.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682365|NCT01217112|3094477|Superiority or Other||Mean Difference (Final Values)|4.07|Standard Error of the Mean|1.532||0.014|2-Sided|90.0|1.44|6.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682366|NCT01217112|3094477|Superiority or Other||Mean Difference (Final Values)|3.1|Standard Error of the Mean|1.26||0.022|2-Sided|90.0|0.94|5.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682367|NCT01217112|3094478|Superiority or Other||Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.408||0.424|2-Sided|90.0|-0.37|1.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682368|NCT01217112|3094478|Superiority or Other||Mean Difference (Final Values)|0.62|Standard Error of the Mean|0.434||0.166|2-Sided|90.0|-0.12|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682369|NCT01217112|3094478|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.489||0.708|2-Sided|90.0|-0.65|1.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682370|NCT01217112|3094478|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.391||0.482|2-Sided|90.0|-0.39|0.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682371|NCT01217112|3094479|Superiority or Other||Mean Difference (Final Values)|-0.79|Standard Error of the Mean|0.849||0.355|2-Sided|90.0|-2.22|0.63|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682372|NCT01217112|3094479|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.803||0.637|2-Sided|90.0|-1.73|0.96|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682373|NCT01217112|3094479|Superiority or Other||Mean Difference (Final Values)|0.37|Standard Error of the Mean|0.908||0.688|2-Sided|90.0|-1.15|1.89|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682374|NCT01217112|3094479|Superiority or Other||Mean Difference (Final Values)|-0.75|Standard Error of the Mean|0.837||0.376|2-Sided|90.0|-2.15|0.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682375|NCT01217112|3094480|Superiority or Other||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|0.412||0.382|2-Sided|90.0|-1.05|0.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682376|NCT01217112|3094480|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.392||0.245|2-Sided|90.0|-1.12|0.2|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682377|NCT01217112|3094480|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.439||0.909|2-Sided|90.0|-0.68|0.79|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682378|NCT01217112|3094480|Superiority or Other||Mean Difference (Final Values)|-0.64|Standard Error of the Mean|0.406||0.124|2-Sided|90.0|-1.32|0.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682379|NCT01217112|3094481|Superiority or Other||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.526||0.467|2-Sided|90.0|-1.27|0.5|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682380|NCT01217112|3094481|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.495||0.859|2-Sided|90.0|-0.74|0.92|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682381|NCT01217112|3094481|Superiority or Other||Mean Difference (Final Values)|0.34|Standard Error of the Mean|0.549||0.543|2-Sided|90.0|-0.58|1.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682382|NCT01217112|3094481|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.512||0.857|2-Sided|90.0|-0.95|0.76|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682383|NCT01217112|3094482|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|1.327||0.978|2-Sided|90.0|-2.26|2.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682384|NCT01217112|3094482|Superiority or Other||Mean Difference (Final Values)|0.54|Standard Error of the Mean|1.281||0.672|2-Sided|90.0|-1.6|2.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682385|NCT01217112|3094482|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Error of the Mean|1.303||0.851|2-Sided|90.0|-1.93|2.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682386|NCT01217112|3094482|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|1.32||0.327|2-Sided|90.0|-0.9|3.51|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682387|NCT01217112|3094483|Superiority or Other||Mean Difference (Final Values)|0.51|Standard Error of the Mean|1.304||0.696|2-Sided|90.0|-1.67|2.69|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682388|NCT01217112|3094483|Superiority or Other||Mean Difference (Final Values)|1.13|Standard Error of the Mean|1.249||0.368|2-Sided|90.0|-0.96|3.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682389|NCT01217112|3094483|Superiority or Other||Mean Difference (Final Values)|0.72|Standard Error of the Mean|1.28||0.578|2-Sided|90.0|-1.43|2.86|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682390|NCT01217112|3094483|Superiority or Other||Mean Difference (Final Values)|1.74|Standard Error of the Mean|1.299||0.187|2-Sided|90.0|-0.44|3.91|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682391|NCT01217112|3094484|Superiority or Other||Mean Difference (Final Values)|1.52|Standard Error of the Mean|1.612||0.348|2-Sided|90.0|-1.17|4.22|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682392|NCT01217112|3094484|Superiority or Other||Mean Difference (Final Values)|1.61|Standard Error of the Mean|1.563||0.307|2-Sided|90.0|-1.0|4.23|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682393|NCT01217112|3094484|Superiority or Other||Mean Difference (Final Values)|1.99|Standard Error of the Mean|1.598||0.219|2-Sided|90.0|-0.69|4.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682394|NCT01217112|3094484|Superiority or Other||Mean Difference (Final Values)|0.75|Standard Error of the Mean|1.616||0.646|2-Sided|90.0|-1.96|3.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682395|NCT01217112|3094485|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.013||0.465|2-Sided|90.0|-0.01|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682922|NCT01214434|3094965|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1682396|NCT01217112|3094485|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.013||0.915|2-Sided|90.0|-0.02|0.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682397|NCT01217112|3094485|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.013||0.34|2-Sided|90.0|-0.01|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682398|NCT01217112|3094485|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.013||0.417|2-Sided|90.0|-0.01|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682399|NCT01217112|3094486|Superiority or Other||Mean Difference (Final Values)|0.49|Standard Error of the Mean|0.532||0.361|2-Sided|90.0|-0.4|1.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682400|NCT01217112|3094486|Superiority or Other||Mean Difference (Final Values)|0.46|Standard Error of the Mean|0.514||0.378|2-Sided|90.0|-0.4|1.32|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682401|NCT01217112|3094486|Superiority or Other||Mean Difference (Final Values)|0.66|Standard Error of the Mean|0.531||0.218|2-Sided|90.0|-0.23|1.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682402|NCT01217112|3094486|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.536||0.717|2-Sided|90.0|-0.7|1.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682403|NCT01217112|3094487|Superiority or Other||Mean Difference (Final Values)|44.51|Standard Error of the Mean|15.834||0.007|2-Sided|90.0|17.98|71.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682404|NCT01217112|3094487|Superiority or Other||Mean Difference (Final Values)|4.39|Standard Error of the Mean|15.369||0.776|2-Sided|90.0|-21.37|30.15|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682405|NCT01217112|3094487|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|15.825||0.99|2-Sided|90.0|-26.32|26.72|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682406|NCT01217112|3094487|Superiority or Other||Mean Difference (Final Values)|10.45|Standard Error of the Mean|16.445||0.528|2-Sided|90.0|-17.12|38.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682407|NCT01217112|3094488|Superiority or Other||Mean Difference (Final Values)|9.2|Standard Error of the Mean|8.328||0.275|2-Sided|90.0|-4.76|23.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682408|NCT01217112|3094488|Superiority or Other||Mean Difference (Final Values)|4.72|Standard Error of the Mean|7.989||0.557|2-Sided|90.0|-8.67|18.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682409|NCT01217112|3094488|Superiority or Other||Mean Difference (Final Values)|0.85|Standard Error of the Mean|8.377||0.919|2-Sided|90.0|-13.18|14.89|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682410|NCT01217112|3094488|Superiority or Other||Mean Difference (Final Values)|-1.33|Standard Error of the Mean|8.633||0.878|2-Sided|90.0|-15.8|13.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682411|NCT01217112|3094489|Superiority or Other||Mean Difference (Final Values)|0.45|Standard Error of the Mean|0.722||0.536|2-Sided|90.0|-0.76|1.66|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682412|NCT01217112|3094489|Superiority or Other||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.703||0.693|2-Sided|90.0|-1.46|0.9|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682413|NCT01217112|3094489|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.721||0.826|2-Sided|90.0|-1.05|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682414|NCT01217112|3094489|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.745||0.871|2-Sided|90.0|-1.13|1.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682415|NCT01217112|3094490|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.099||0.895|2-Sided|90.0|-0.15|0.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682416|NCT01217112|3094490|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.098||0.176|2-Sided|90.0|-0.3|0.03|||ANCOVA|||v Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682417|NCT01217112|3094490|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.101||0.984|2-Sided|90.0|-0.17|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682418|NCT01217112|3094490|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.106||0.569|2-Sided|90.0|-0.24|0.12|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682419|NCT01217112|3094491|Superiority or Other||Mean Difference (Final Values)|42.51|Standard Error of the Mean|39.68||0.289|2-Sided|90.0|-23.99|109.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682420|NCT01217112|3094491|Superiority or Other||Mean Difference (Final Values)|-11.62|Standard Error of the Mean|39.044||0.767|2-Sided|90.0|-77.06|53.81|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682421|NCT01217112|3094491|Superiority or Other||Mean Difference (Final Values)|8.31|Standard Error of the Mean|39.521||0.834|2-Sided|90.0|-57.92|74.55|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682422|NCT01217112|3094491|Superiority or Other||Mean Difference (Final Values)|8.33|Standard Error of the Mean|40.94||0.84|2-Sided|90.0|-60.28|76.94|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682423|NCT01217112|3094492|Superiority or Other||Mean Difference (Final Values)|97.42|Standard Error of the Mean|149.124||0.517|2-Sided|90.0|-153.02|347.86|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682424|NCT01217112|3094492|Superiority or Other||Mean Difference (Final Values)|-111.5|Standard Error of the Mean|146.276||0.45|2-Sided|90.0|-357.17|134.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682425|NCT01217112|3094492|Superiority or Other||Mean Difference (Final Values)|-70.76|Standard Error of the Mean|156.72||0.654|2-Sided|90.0|-333.96|192.44|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682426|NCT01217112|3094492|Superiority or Other||Mean Difference (Final Values)|50.89|Standard Error of the Mean|168.459||0.764|2-Sided|90.0|-232.02|333.8|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682427|NCT01217112|3094493|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.964||0.889|2-Sided|90.0|-1.48|1.75|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682428|NCT01217112|3094493|Superiority or Other||Mean Difference (Final Values)|-0.95|Standard Error of the Mean|0.934||0.314|2-Sided|90.0|-2.52|0.62|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682429|NCT01217112|3094493|Superiority or Other||Mean Difference (Final Values)|0.93|Standard Error of the Mean|0.973||0.342|2-Sided|90.0|-0.7|2.57|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682430|NCT01217112|3094493|Superiority or Other||Mean Difference (Final Values)|-0.56|Standard Error of the Mean|1.097||0.615|2-Sided|90.0|-2.4|1.29|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682431|NCT01217112|3094494|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.283||0.273|2-Sided|90.0|-0.79|0.16|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682432|NCT01217112|3094494|Superiority or Other||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.269||0.447|2-Sided|90.0|-0.66|0.24|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682433|NCT01217112|3094494|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.283||0.648|2-Sided|90.0|-0.6|0.34|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682434|NCT01217112|3094494|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.294||0.576|2-Sided|90.0|-0.66|0.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682435|NCT01217112|3094495|Superiority or Other||Mean Difference (Final Values)|-6.67|Standard Error of the Mean|10.256||0.518|2-Sided|90.0|-23.86|10.51|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682436|NCT01217112|3094495|Superiority or Other||Mean Difference (Final Values)|-15.96|Standard Error of the Mean|10.026||0.118|2-Sided|90.0|-32.76|0.84|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682437|NCT01217112|3094495|Superiority or Other||Mean Difference (Final Values)|2.11|Standard Error of the Mean|10.692||0.844|2-Sided|90.0|-15.81|20.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682438|NCT01217112|3094495|Superiority or Other||Mean Difference (Final Values)|-9.9|Standard Error of the Mean|10.838||0.366|2-Sided|90.0|-28.06|8.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682439|NCT01217112|3094496|Superiority or Other||Mean Difference (Final Values)|-1.23|Standard Error of the Mean|0.583||0.04|2-Sided|90.0|-2.2|-0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682440|NCT01217112|3094496|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.556||0.916|2-Sided|90.0|-0.87|0.99|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682441|NCT01217112|3094496|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.585||0.804|2-Sided|90.0|-0.84|1.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682442|NCT01217112|3094496|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.613||0.533|2-Sided|90.0|-1.41|0.64|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682443|NCT01217112|3094497|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.081||0.467|2-Sided|90.0|-0.08|0.19|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682444|NCT01217112|3094497|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.077||0.837|2-Sided|90.0|-0.15|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682445|NCT01217112|3094497|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.082||0.579|2-Sided|90.0|-0.09|0.18|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682446|NCT01217112|3094497|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.084||0.236|2-Sided|90.0|-0.04|0.24|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682447|NCT01217112|3094498|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.056||0.075|2-Sided|90.0|-0.2|-0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682448|NCT01217112|3094498|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.053||0.593|2-Sided|90.0|-0.06|0.12|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682449|NCT01217112|3094498|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.056||0.727|2-Sided|90.0|-0.07|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682450|NCT01217112|3094498|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.058||0.233|2-Sided|90.0|-0.17|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682451|NCT01217112|3094499|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.232||0.624|2-Sided|90.0|-0.5|0.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682452|NCT01217112|3094499|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.226||0.701|2-Sided|90.0|-0.29|0.47|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682453|NCT01217112|3094499|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.238||0.438|2-Sided|90.0|-0.21|0.59|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682454|NCT01217112|3094499|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.245||0.325|2-Sided|90.0|-0.65|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682455|NCT01217112|3094500|Superiority or Other||Mean Difference (Final Values)|6.02|Standard Error of the Mean|2.486||0.019|2-Sided|90.0|1.86|10.19|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682456|NCT01217112|3094500|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|2.406||0.9|2-Sided|90.0|-3.72|4.33|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682457|NCT01217112|3094500|Superiority or Other||Mean Difference (Final Values)|2.36|Standard Error of the Mean|2.545||0.358|2-Sided|90.0|-1.9|6.62|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682458|NCT01217112|3094500|Superiority or Other||Mean Difference (Final Values)|2.55|Standard Error of the Mean|2.624||0.335|2-Sided|90.0|-1.84|6.95|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682459|NCT01217112|3094501|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.222||0.867|2-Sided|90.0|-0.33|0.41|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682460|NCT01217112|3094501|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.24||0.621|2-Sided|90.0|-0.28|0.52|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682461|NCT01217112|3094501|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.227||0.669|2-Sided|90.0|-0.28|0.48|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682462|NCT01217112|3094501|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.231||0.614|2-Sided|90.0|-0.5|0.27|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682463|NCT01217112|3094502|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.232||0.302|2-Sided|90.0|-0.15|0.63|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682464|NCT01217112|3094502|Superiority or Other||Mean Difference (Final Values)|0.31|Standard Error of the Mean|0.222||0.164|2-Sided|90.0|-0.06|0.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682465|NCT01217112|3094502|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.236||0.232|2-Sided|90.0|-0.11|0.68|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682466|NCT01217112|3094502|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.241||0.329|2-Sided|90.0|-0.64|0.17|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682467|NCT01217112|3094503|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.103||0.556|2-Sided|90.0|-0.11|0.23|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682468|NCT01217112|3094503|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.111||0.236|2-Sided|90.0|-0.05|0.32|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682469|NCT01217112|3094503|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.105||0.418|2-Sided|90.0|-0.09|0.26|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682470|NCT01217112|3094503|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.108||0.815|2-Sided|90.0|-0.16|0.21|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682471|NCT01217112|3094504|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.037||0.617|2-Sided|90.0|-0.04|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1683140|NCT01211769|3095325|Superiority or Other||Variance (F)|0.73||||0.53||95.0|||||ANOVA|||GROUP COMPARISON|
1682472|NCT01217112|3094504|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.039||0.403|2-Sided|90.0|-0.1|0.03|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682473|NCT01217112|3094504|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.037||0.956|2-Sided|90.0|-0.06|0.06|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682474|NCT01217112|3094504|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.039||0.56|2-Sided|90.0|-0.09|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682475|NCT01217112|3094505|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.032||0.484|2-Sided|90.0|-0.03|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682476|NCT01217112|3094505|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.032||0.267|2-Sided|90.0|-0.09|0.02|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682477|NCT01217112|3094505|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.032||0.714|2-Sided|90.0|-0.04|0.07|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682478|NCT01217112|3094505|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.034||0.408|2-Sided|90.0|-0.03|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682479|NCT01217112|3094506|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.136||0.876|2-Sided|90.0|-0.21|0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682480|NCT01217112|3094506|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.148||0.466|2-Sided|90.0|-0.14|0.36|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682481|NCT01217112|3094506|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.144||0.705|2-Sided|90.0|-0.19|0.3|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682482|NCT01217112|3094506|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.143||0.956|2-Sided|90.0|-0.23|0.25|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682483|NCT01217112|3094507|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.166||0.993|2-Sided|90.0|-0.28|0.28|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682484|NCT01217112|3094507|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.173||0.902|2-Sided|90.0|-0.27|0.31|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682485|NCT01217112|3094507|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.177||0.782|2-Sided|90.0|-0.25|0.35|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682486|NCT01217112|3094507|Superiority or Other||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.181||0.115|2-Sided|90.0|-0.59|0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682487|NCT01217112|3094508|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.188||0.472|2-Sided|90.0|-0.18|0.45|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682488|NCT01217112|3094508|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.203||0.356|2-Sided|90.0|-0.15|0.53|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682489|NCT01217112|3094508|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.196||0.575|2-Sided|90.0|-0.22|0.44|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682490|NCT01217112|3094508|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.198||0.829|2-Sided|90.0|-0.29|0.37|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1683141|NCT01211769|3095325|Superiority or Other||||||<|0.001|||||||ANOVA|||TIME COMPARISON|
1682491|NCT01217112|3094509|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.17||0.58|2-Sided|90.0|-0.19|0.38|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682492|NCT01217112|3094509|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.169||0.388|2-Sided|90.0|-0.14|0.43|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682493|NCT01217112|3094509|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.177||0.583|2-Sided|90.0|-0.2|0.39|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682494|NCT01217112|3094509|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.18||0.088|2-Sided|90.0|-0.61|-0.01|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682495|NCT01217112|3094510|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.045||0.26|2-Sided|90.0|-0.02|0.13|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682496|NCT01217112|3094510|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.05||0.537|2-Sided|90.0|-0.12|0.05|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682497|NCT01217112|3094510|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.045||0.864|2-Sided|90.0|-0.08|0.07|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682498|NCT01217112|3094510|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.046||0.978|2-Sided|90.0|-0.08|0.08|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682499|NCT01217112|3094511|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.043||0.668|2-Sided|90.0|-0.05|0.09|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682500|NCT01217112|3094511|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.041||0.412|2-Sided|90.0|-0.1|0.04|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682501|NCT01217112|3094511|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.043||0.424|2-Sided|90.0|-0.04|0.11|||ANCOVA|||Data was analysed by ANCOVA. The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682502|NCT01217112|3094511|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.044||0.766|2-Sided|90.0|-0.09|0.06|||ANCOVA|||Data was analysed by analysis of covariance (ANCOVA). The fitted ANCOVA models included the baseline parameter scores as covariate, with treatment group and gender as factors. All statistical tests were two-sided at the 10% significance level.|
1682503|NCT01217073|3094518|Superiority or Other||Difference in least squares mean|-2.5||||0.539|2-Sided|95.0|-10.4|5.5||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682504|NCT01217073|3094518|Superiority or Other||Difference in least squares mean|-19.0|||<|0.001|2-Sided|95.0|-26.9|-11.2||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682505|NCT01217073|3094518|Superiority or Other||Difference in least squares mean|-14.3|||<|0.001|2-Sided|95.0|-22.2|-6.3||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682506|NCT01217073|3094518|Superiority or Other||Difference in least squares mean|-13.5|||<|0.001|2-Sided|95.0|-21.3|-5.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682507|NCT01217073|3094518|Superiority or Other||Difference in least squares mean|-21.4|||<|0.001|2-Sided|95.0|-29.4|-13.4||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682508|NCT01217073|3094519|Superiority or Other||Difference in least squares mean|-18.8||||0.009|2-Sided|95.0|-32.9|-4.8||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682770|NCT01215955|3094637|Superiority or Other||LS Mean Difference|5.37||||0.156|2-Sided|95.0|-2.06|12.79||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682509|NCT01217073|3094519|Superiority or Other||Difference in least squares mean|-33.5|||<|0.001||95.0|-47.3|-19.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682510|NCT01217073|3094519|Superiority or Other||Difference in least squares mean|-35.1|||<|0.001|2-Sided|95.0|-48.9|-21.3||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682511|NCT01217073|3094519|Superiority or Other||Difference in least squares mean|-41.6|||<|0.001|2-Sided|95.0|-55.3|-27.8||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682512|NCT01217073|3094519|Superiority or Other||Difference in least squares mean|-44.9|||<|0.001|2-Sided|95.0|-59.0|-30.7||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682513|NCT01217073|3094520|Superiority or Other||Difference in percent|-1.4|||||2-Sided|95.0|-9.1|2.6|||||||
1682514|NCT01217073|3094521|Superiority or Other||Difference in percent|1.0|||||2-Sided|95.0|-9.8|13.1|||||||
1682515|NCT01217073|3094522|Superiority or Other||Difference in percentage|2.6|||||2-Sided|95.0|-1.7|7.9|||||||
1682516|NCT01217073|3094522|Superiority or Other||Difference in percentage|-0.9|||||2-Sided|95.0|-4.9|2.4|||||||
1682517|NCT01217073|3094522|Superiority or Other||Difference in percentage|0.0|||||2-Sided|95.0|-4.1|4.0|||||||
1682518|NCT01217073|3094522|Superiority or Other||Difference in percentage|-0.9|||||2-Sided|95.0|-4.9|2.4|||||||
1682519|NCT01217073|3094522|Superiority or Other||Difference in percentage|0.0|||||2-Sided|95.0|-4.1|4.1|||||||
1682520|NCT01217073|3094523|Superiority or Other||Difference in percentage|2.4|||||2-Sided|95.0|-9.8|14.5|||||||
1682521|NCT01217073|3094523|Superiority or Other||Difference in percentage|5.5|||||2-Sided|95.0|-6.8|17.7|||||||
1682522|NCT01217073|3094523|Superiority or Other||Difference in percentage|5.9|||||2-Sided|95.0|-6.5|18.0|||||||
1682523|NCT01217073|3094523|Superiority or Other||Difference in percentage|12.5|||||2-Sided|95.0|-0.1|24.7|||||||
1682524|NCT01217073|3094523|Superiority or Other||Difference in percentage|6.2|||||2-Sided|95.0|-6.2|18.4|||||||
1682525|NCT01217073|3094524|Superiority or Other||Difference in least squares mean|-0.28||||0.012|2-Sided|95.0|-0.5|-0.06||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682526|NCT01217073|3094524|Superiority or Other||Difference in least squares mean|-0.5|||<|0.001|2-Sided|95.0|-0.71|-0.28||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682527|NCT01217073|3094524|Superiority or Other||Difference in least squares mean|-0.49|||<|0.001|2-Sided|95.0|-0.7|-0.27||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682528|NCT01217073|3094524|Superiority or Other||Difference in least squares mean|-0.67|||<|0.001|2-Sided|95.0|-0.88|-0.45||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682529|NCT01217073|3094524|Superiority or Other||Difference in least squares mean|-0.71|||<|0.001|2-Sided|95.0|-0.93|-0.5||With terms for treatment, prior AHA therapy status, geographic region (Japan/ex-Japan), and the interaction of time by treatment, time by prior AHA therapy status, with the constraint that the mean baseline is the same for all treatment groups.|Constrained longitudinal data analysis||||
1682530|NCT01216397|3094568|Superiority or Other||adjusted gMean ratio|100.3||||||90.0|95.7|105.2||||||Standard batch vs. Side batch|
1682531|NCT01216397|3094569|Superiority or Other||adjusted gMean ratio|100.4||||||90.0|95.7|105.4|||||||
1682532|NCT01216397|3094570|Superiority or Other||adjusted gMean ratio|97.9||||||90.0|92.5|103.7||||||Standard batch vs. Side batch|
1682533|NCT01216397|3094578|Superiority or Other||adjusted gMean ratio|100.1||||||90.0|94.7|105.8||||||Standard batch vs. Side batch|
1682534|NCT01216397|3094579|Superiority or Other||adjusted gMean ratio|100.1||||||90.0|96.1|104.2||||||Standard batch vs. Side batch|
1682535|NCT01216397|3094580|Superiority or Other||adjusted gMean ratio|99.4||||||90.0|94.2|105.0||||||Standard batch vs. Side batch|
1682536|NCT01216163|3094600|Superiority or Other||Mean Difference (Final Values)|0.77|||<|0.001|2-Sided|95.0|0.63|0.91||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Acetaminophen - Placebo) and the associated CI were calculated based on the weighted Gamma statistic.|
1682537|NCT01216163|3094600|Superiority or Other||Mean Difference (Final Values)|0.25|||<|0.02|2-Sided|95.0|0.05|0.45||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - Acetaminophen) and the associated CI were calculated based on the weighted Gamma statistic.|
1682771|NCT01215955|3094637|Superiority or Other||LS Mean Difference|1.09||||0.497|2-Sided|95.0|-2.05|4.23||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682538|NCT01216163|3094600|Superiority or Other||Mean Difference (Final Values)|0.87|||<|0.001|2-Sided|95.0|0.78|0.96||P-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - Placebo) and the associated CI were calculated based on the weighted Gamma statistic.|
1682539|NCT01216163|3094601|Superiority or Other||Difference in proportion|26.97|||<|0.001|2-Sided|95.0|14.0|39.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682540|NCT01216163|3094601|Superiority or Other||Difference in proportion|10.97|||<|0.144|2-Sided|95.0|-3.67|25.61||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682541|NCT01216163|3094601|Superiority or Other||Difference in proportion|37.72|||<|0.001|2-Sided|95.0|24.36|51.07||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682542|NCT01216163|3094601|Superiority or Other||Difference in proportion|26.97|||<|0.001|2-Sided|95.0|14.0|39.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682543|NCT01216163|3094601|Superiority or Other||Difference in proportion|9.83|||<|0.189|2-Sided|95.0|-4.8|24.45||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682544|NCT01216163|3094601|Superiority or Other||Difference in proportion|36.55|||<|0.001|2-Sided|95.0|23.22|49.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682545|NCT01216163|3094601|Superiority or Other||Difference in proportion|29.19|||<|0.001|2-Sided|95.0|16.71|41.66||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682546|NCT01216163|3094601|Superiority or Other||Difference in proportion|9.83|||<|0.189|2-Sided|95.0|-4.8|24.45||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682547|NCT01216163|3094601|Superiority or Other||Difference in proportion|38.73|||<|0.001|2-Sided|95.0|25.87|51.6||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682548|NCT01216163|3094601|Superiority or Other||Difference in proportion|28.96|||<|0.001|2-Sided|95.0|17.17|40.75||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682549|NCT01216163|3094601|Superiority or Other||Difference in proportion|8.85|||<|0.233|2-Sided|95.0|-5.72|23.42||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682550|NCT01216163|3094601|Superiority or Other||Difference in proportion|37.64|||<|0.001|2-Sided|95.0|25.47|49.81||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682551|NCT01216163|3094601|Superiority or Other||Difference in proportion|25.34|||<|0.001|2-Sided|95.0|13.73|36.94||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682552|NCT01216163|3094601|Superiority or Other||Difference in proportion|6.7|||<|0.349|2-Sided|95.0|-7.38|20.79||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682553|NCT01216163|3094601|Superiority or Other||Difference in proportion|31.78|||<|0.001|2-Sided|95.0|20.03|43.53||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682554|NCT01216163|3094601|Superiority or Other||Difference in proportion|25.13|||<|0.001|2-Sided|95.0|15.81|34.46||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682555|NCT01216163|3094601|Superiority or Other||Difference in proportion|4.61|||<|0.497|2-Sided|95.0|-8.78|17.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682556|NCT01216163|3094601|Superiority or Other||Difference in proportion|29.41|||<|0.001|2-Sided|95.0|19.78|39.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682557|NCT01216163|3094601|Superiority or Other||Difference in proportion|15.46|||<|0.006|2-Sided|95.0|7.66|23.26||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682558|NCT01216163|3094601|Superiority or Other||Difference in proportion|8.45|||<|0.165|2-Sided|95.0|-3.43|20.33||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682559|NCT01216163|3094601|Superiority or Other||Difference in proportion|23.86|||<|0.001|2-Sided|95.0|14.81|32.91||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682560|NCT01216163|3094601|Superiority or Other||Difference in proportion|4.81|||<|0.137|2-Sided|95.0|0.14|9.49||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682561|NCT01216163|3094601|Superiority or Other||Difference in proportion|1.96|||<|0.583|2-Sided|95.0|-4.94|8.85||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682562|NCT01216163|3094601|Superiority or Other||Difference in proportion|6.81|||<|0.073|2-Sided|95.0|1.57|12.06||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682563|NCT01216163|3094601|Superiority or Other||Difference in proportion|1.21|||<|0.458|2-Sided|95.0|-1.16|3.58||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682564|NCT01216163|3094601|Superiority or Other||Difference in proportion|-1.21|||<|0.294|2-Sided|95.0|-3.59|1.17||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682565|NCT01216163|3094602|Superiority or Other||Difference in proportion|-47.72|||<|0.001|2-Sided|95.0|-62.62|-32.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682566|NCT01216163|3094602|Superiority or Other||Difference in proportion|-5.51|||<|0.439|2-Sided|95.0|-19.27|8.25||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682567|NCT01216163|3094602|Superiority or Other||Difference in proportion|-52.75|||<|0.001|2-Sided|95.0|-67.62|-37.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682568|NCT01216163|3094602|Superiority or Other||Difference in proportion|-49.93|||<|0.001|2-Sided|95.0|-64.74|-35.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682569|NCT01216163|3094602|Superiority or Other||Difference in proportion|-7.73|||<|0.263|2-Sided|95.0|-21.08|5.63||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682570|NCT01216163|3094602|Superiority or Other||Difference in proportion|-57.33|||<|0.001|2-Sided|95.0|-71.9|-42.77||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682571|NCT01216163|3094602|Superiority or Other||Difference in proportion|-55.53|||<|0.001|2-Sided|95.0|-70.12|-40.85||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682572|NCT01216163|3094602|Superiority or Other||Difference in proportion|-11.03|||<|0.079|2-Sided|95.0|-23.37|1.21||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682573|NCT01216163|3094602|Superiority or Other||Difference in proportion|-66.37|||<|0.001|2-Sided|95.0|-80.08|-52.66||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682574|NCT01216163|3094602|Superiority or Other||Difference in proportion|-61.14|||<|0.001|2-Sided|95.0|-75.4|-46.87||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682575|NCT01216163|3094602|Superiority or Other||Difference in proportion|-9.82|||<|0.083|2-Sided|95.0|-20.18|1.16||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682576|NCT01216163|3094602|Superiority or Other||Difference in proportion|-71.01|||<|0.001|2-Sided|95.0|-84.09|-57.93||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682577|NCT01216163|3094602|Superiority or Other||Difference in proportion|-56.39|||<|0.001|2-Sided|95.0|-71.68|-41.09||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682578|NCT01216163|3094602|Superiority or Other||Difference in proportion|-7.17|||<|0.108|2-Sided|95.0|-15.91|1.57||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682579|NCT01216163|3094602|Superiority or Other||Difference in proportion|-63.4|||<|0.001|2-Sided|95.0|-77.81|-48.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682580|NCT01216163|3094602|Superiority or Other||Difference in proportion|-40.19|||<|0.001|2-Sided|95.0|-55.51|-24.87||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682581|NCT01216163|3094602|Superiority or Other||Difference in proportion|-0.12|||<|0.958|2-Sided|95.0|-4.52|4.28||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682582|NCT01216163|3094602|Superiority or Other||Difference in proportion|-40.1|||<|0.001|2-Sided|95.0|-55.39|-24.8||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682583|NCT01216163|3094603|Superiority or Other||Hazard Ratio (HR)|0.17|||<|0.001|2-Sided|95.0|0.1|0.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1682584|NCT01216163|3094603|Superiority or Other||Hazard Ratio (HR)|0.76|||<|0.303|2-Sided|95.0|0.45|1.28||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1682585|NCT01216163|3094603|Superiority or Other||Hazard Ratio (HR)|0.13|||<|0.001|2-Sided|95.0|0.08|0.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1682777|NCT01215955|3094638|Superiority or Other||LS Mean Difference|5.66||||0.14|2-Sided|95.0|-1.86|13.17||P-value is for Evening Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682586|NCT01216163|3094604|Superiority or Other||Difference in proportion|61.14|||<|0.001|2-Sided|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682587|NCT01216163|3094604|Superiority or Other||Difference in proportion|5.31|||<|0.412|2-Sided|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682588|NCT01216163|3094604|Superiority or Other||Difference in proportion|66.44|||<|0.001|2-Sided|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682589|NCT01216163|3094604|Superiority or Other||Difference in proportion|61.14|||<|0.001|2-Sided|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682590|NCT01216163|3094604|Superiority or Other||Difference in proportion|5.31|||<|0.412|2-Sided|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682591|NCT01216163|3094604|Superiority or Other||Difference in proportion|66.44|||<|0.001|2-Sided|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682592|NCT01216163|3094604|Superiority or Other||Difference in proportion|61.14|||<|0.001|2-Sided|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682593|NCT01216163|3094604|Superiority or Other||Difference in proportion|5.31|||<|0.412|2-Sided|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682594|NCT01216163|3094604|Superiority or Other||Difference in proportion|66.44|||<|0.001|2-Sided|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682595|NCT01216163|3094604|Superiority or Other||Difference in proportion|61.14|||<|0.001|2-Sided|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682596|NCT01216163|3094604|Superiority or Other||Difference in proportion|5.31|||<|0.412|2-Sided|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682597|NCT01216163|3094604|Superiority or Other||Difference in proportion|66.44|||<|0.001|2-Sided|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682598|NCT01216163|3094604|Superiority or Other||Difference in proportion|61.14|||<|0.001|2-Sided|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682599|NCT01216163|3094604|Superiority or Other||Difference in proportion|5.31|||<|0.412|2-Sided|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682600|NCT01216163|3094604|Superiority or Other||Difference in proportion|66.44|||<|0.001|2-Sided|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682601|NCT01216163|3094604|Superiority or Other||Difference in proportion|63.34|||<|0.001|2-Sided|95.0|50.32|76.35||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682602|NCT01216163|3094604|Superiority or Other||Difference in proportion|5.31|||<|0.412|2-Sided|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682603|NCT01216163|3094604|Superiority or Other||Difference in proportion|68.64|||<|0.001|2-Sided|95.0|56.11|81.16||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682604|NCT01216163|3094604|Superiority or Other||Difference in proportion|62.13|||<|0.001|2-Sided|95.0|48.96|75.29||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682605|NCT01216163|3094604|Superiority or Other||Difference in proportion|5.42|||<|0.41|2-Sided|95.0|-7.34|18.18||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682606|NCT01216163|3094604|Superiority or Other||Difference in proportion|67.52|||<|0.001|2-Sided|95.0|54.91|80.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682607|NCT01216163|3094604|Superiority or Other||Difference in proportion|58.32|||<|0.001|2-Sided|95.0|46.59|70.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682608|NCT01216163|3094604|Superiority or Other||Difference in proportion|2.25|||<|0.761|2-Sided|95.0|-12.1|16.59||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682609|NCT01216163|3094604|Superiority or Other||Difference in proportion|60.37|||<|0.001|2-Sided|95.0|48.61|72.12||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682610|NCT01216163|3094604|Superiority or Other||Difference in proportion|22.72|||<|0.001|2-Sided|95.0|12.39|33.05||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682611|NCT01216163|3094604|Superiority or Other||Difference in proportion|3.53|||<|0.602|2-Sided|95.0|-9.85|16.91||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682612|NCT01216163|3094604|Superiority or Other||Difference in proportion|26.4|||<|0.001|2-Sided|95.0|15.87|36.93||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682613|NCT01216163|3094605|Superiority or Other||Difference in proportion|61.14|||<|0.001|2-Sided|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682614|NCT01216163|3094605|Superiority or Other||Difference in proportion|5.31|||<|0.412|2-Sided|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682615|NCT01216163|3094605|Superiority or Other||Difference in proportion|66.44|||<|0.001|2-Sided|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682616|NCT01216163|3094605|Superiority or Other||Difference in proportion|61.14|||<|0.001|2-Sided|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682617|NCT01216163|3094605|Superiority or Other||Difference in proportion|5.31|||<|0.412|2-Sided|95.0|-7.22|17.83||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682618|NCT01216163|3094605|Superiority or Other||Difference in proportion|66.44|||<|0.001|2-Sided|95.0|53.38|79.51||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682619|NCT01216163|3094605|Superiority or Other||Difference in proportion|61.14|||<|0.001|2-Sided|95.0|47.6|74.68||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682620|NCT01216163|3094605|Superiority or Other||Difference in proportion|4.21|||<|0.519|2-Sided|95.0|-8.39|16.81||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682621|NCT01216163|3094605|Superiority or Other||Difference in proportion|65.32|||<|0.001|2-Sided|95.0|52.18|78.46||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682622|NCT01216163|3094605|Superiority or Other||Difference in proportion|60.92|||<|0.001|2-Sided|95.0|47.65|74.19||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682623|NCT01216163|3094605|Superiority or Other||Difference in proportion|5.46|||<|0.415|2-Sided|95.0|-7.53|18.44||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682624|NCT01216163|3094605|Superiority or Other||Difference in proportion|66.35|||<|0.001|2-Sided|95.0|53.61|79.09||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682625|NCT01216163|3094605|Superiority or Other||Difference in proportion|61.93|||<|0.001|2-Sided|95.0|49.06|74.8||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682626|NCT01216163|3094605|Superiority or Other||Difference in proportion|4.38|||<|0.522|2-Sided|95.0|-8.89|17.64||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682627|NCT01216163|3094605|Superiority or Other||Difference in proportion|66.24|||<|0.001|2-Sided|95.0|53.77|78.71||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682628|NCT01216163|3094605|Superiority or Other||Difference in proportion|62.88|||<|0.001|2-Sided|95.0|51.78|73.99||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682629|NCT01216163|3094605|Superiority or Other||Difference in proportion|7.99|||<|0.261|2-Sided|95.0|-5.85|21.84||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682630|NCT01216163|3094605|Superiority or Other||Difference in proportion|70.58|||<|0.001|2-Sided|95.0|60.28|80.88||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682631|NCT01216163|3094605|Superiority or Other||Difference in proportion|57.06|||<|0.001|2-Sided|95.0|46.53|67.6||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682632|NCT01216163|3094605|Superiority or Other||Difference in proportion|-2.98|||<|0.695|2-Sided|95.0|-17.67|11.7||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682633|NCT01216163|3094605|Superiority or Other||Difference in proportion|53.22|||<|0.001|2-Sided|95.0|42.92|63.53||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682634|NCT01216163|3094605|Superiority or Other||Difference in proportion|20.09|||<|0.001|2-Sided|95.0|11.45|28.72||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682635|NCT01216163|3094605|Superiority or Other||Difference in proportion|1.58|||<|0.799|2-Sided|95.0|-10.54|13.7||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and its associated CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1682636|NCT01216163|3094605|Superiority or Other||Difference in proportion|21.42|||<|0.001|2-Sided|95.0|12.99|29.84||p-value was calculated using CMH test, controlling for baseline PSR and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and its associated CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.|
1682637|NCT01216163|3094606|Superiority or Other||LS mean difference|7.24|||<|0.001|2-Sided|95.0|5.21|9.28||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682638|NCT01216163|3094606|Superiority or Other||LS mean difference|2.33|||<|0.006|2-Sided|95.0|0.67|4.0||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682639|NCT01216163|3094606|Superiority or Other||LS mean difference|9.58|||<|0.001|2-Sided|95.0|7.54|11.61||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682640|NCT01216163|3094606|Superiority or Other||LS mean difference|4.87|||<|0.001|2-Sided|95.0|3.63|6.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682641|NCT01216163|3094606|Superiority or Other||LS mean difference|1.33|||<|0.01|2-Sided|95.0|0.32|2.33||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682642|NCT01216163|3094606|Superiority or Other||LS mean difference|6.19|||<|0.001|2-Sided|95.0|4.96|7.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682643|NCT01216163|3094607|Superiority or Other||LS mean difference|8.0|||<|0.001|2-Sided|95.0|5.18|10.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682644|NCT01216163|3094607|Superiority or Other||LS mean difference|2.87|||<|0.015|2-Sided|95.0|0.57|5.18||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682645|NCT01216163|3094607|Superiority or Other||LS mean difference|10.88|||<|0.001|2-Sided|95.0|8.05|13.7||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682646|NCT01216163|3094607|Superiority or Other||LS mean difference|4.56|||<|0.001|2-Sided|95.0|3.31|5.8||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682647|NCT01216163|3094607|Superiority or Other||LS mean difference|1.35|||<|0.01|2-Sided|95.0|0.33|2.37||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682648|NCT01216163|3094607|Superiority or Other||LS mean difference|5.9|||<|0.001|2-Sided|95.0|4.66|7.15||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682649|NCT01216163|3094607|Superiority or Other||LS mean difference|3.04|||<|0.001|2-Sided|95.0|2.29|3.8||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682923|NCT01214239|3094975|Superiority or Other||Odds Ratio (OR)|2.527||||0.0005||95.0|1.494|4.276|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication|||
1682650|NCT01216163|3094607|Superiority or Other||LS mean difference|0.76|||<|0.016|2-Sided|95.0|0.14|1.38||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682651|NCT01216163|3094607|Superiority or Other||LS mean difference|3.81|||<|0.001|2-Sided|95.0|3.05|4.57||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682652|NCT01216163|3094608|Superiority or Other||LS mean difference|4.71|||<|0.001|2-Sided|95.0|2.87|6.54||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682653|NCT01216163|3094608|Superiority or Other||LS mean difference|2.09|||<|0.007|2-Sided|95.0|0.59|3.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682654|NCT01216163|3094608|Superiority or Other||LS mean difference|6.8|||<|0.001|2-Sided|95.0|4.96|8.64||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682655|NCT01216163|3094608|Superiority or Other||LS mean difference|2.69|||<|0.001|2-Sided|95.0|1.87|3.51||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682656|NCT01216163|3094608|Superiority or Other||LS mean difference|0.98|||<|0.004|2-Sided|95.0|0.31|1.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682657|NCT01216163|3094608|Superiority or Other||LS mean difference|3.67|||<|0.001|2-Sided|95.0|2.85|4.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682658|NCT01216163|3094608|Superiority or Other||LS mean difference|1.82|||<|0.001|2-Sided|95.0|1.32|2.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682659|NCT01216163|3094608|Superiority or Other||LS mean difference|0.56|||<|0.007|2-Sided|95.0|0.15|0.97||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682660|NCT01216163|3094608|Superiority or Other||LS mean difference|2.38|||<|0.001|2-Sided|95.0|1.88|2.88||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682661|NCT01216163|3094609|Superiority or Other||LS mean difference|1.54||||0.002|2-Sided|95.0|0.57|2.52||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682662|NCT01216163|3094609|Superiority or Other||LS mean difference|0.85||||0.037|2-Sided|95.0|0.05|1.65||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682663|NCT01216163|3094609|Superiority or Other||LS mean difference|2.39|||<|0.001|2-Sided|95.0|1.41|3.37||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682664|NCT01216163|3094609|Superiority or Other||LS mean difference|1.77|||<|0.001|2-Sided|95.0|0.81|2.73||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682665|NCT01216163|3094609|Superiority or Other||LS mean difference|0.7|||<|0.08|2-Sided|95.0|-0.09|1.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682778|NCT01215955|3094638|Superiority or Other||LS Mean Difference|3.07||||0.426|2-Sided|95.0|-4.5|10.64||P-value is for Midday 2-hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682666|NCT01216163|3094609|Superiority or Other||LS mean difference|2.47|||<|0.001|2-Sided|95.0|1.51|3.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682667|NCT01216163|3094609|Superiority or Other||LS mean difference|2.16|||<|0.001|2-Sided|95.0|1.22|3.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682668|NCT01216163|3094609|Superiority or Other||LS mean difference|1.08|||<|0.006|2-Sided|95.0|0.31|1.85||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682669|NCT01216163|3094609|Superiority or Other||LS mean difference|3.24|||<|0.001|2-Sided|95.0|2.3|4.19||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682670|NCT01216163|3094609|Superiority or Other||LS mean difference|2.38|||<|0.001|2-Sided|95.0|1.46|3.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682671|NCT01216163|3094609|Superiority or Other||LS mean difference|1.01|||<|0.009|2-Sided|95.0|0.26|1.76||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682672|NCT01216163|3094609|Superiority or Other||LS mean difference|3.38|||<|0.001|2-Sided|95.0|2.46|4.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682673|NCT01216163|3094609|Superiority or Other||LS mean difference|2.93|||<|0.001|2-Sided|95.0|2.09|3.77||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682674|NCT01216163|3094609|Superiority or Other||LS mean difference|0.82|||<|0.02|2-Sided|95.0|0.13|1.51||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682675|NCT01216163|3094609|Superiority or Other||LS mean difference|3.75|||<|0.001|2-Sided|95.0|2.9|4.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682676|NCT01216163|3094609|Superiority or Other||LS mean difference|2.99|||<|0.001|2-Sided|95.0|2.24|3.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682677|NCT01216163|3094609|Superiority or Other||LS mean difference|0.69|||<|0.028|2-Sided|95.0|0.07|1.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682678|NCT01216163|3094609|Superiority or Other||LS mean difference|3.68|||<|0.001|2-Sided|95.0|2.92|4.43||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682679|NCT01216163|3094609|Superiority or Other||LS mean difference|2.6|||<|0.001|2-Sided|95.0|1.91|3.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682680|NCT01216163|3094609|Superiority or Other||LS mean difference|0.77|||<|0.008|2-Sided|95.0|0.2|1.33||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682681|NCT01216163|3094609|Superiority or Other||LS mean difference|3.37|||<|0.001|2-Sided|95.0|2.67|4.06||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682772|NCT01215955|3094637|Superiority or Other||LS Mean Difference|8.86||||0.059|2-Sided|95.0|-0.35|18.06||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682682|NCT01216163|3094609|Superiority or Other||LS mean difference|1.84|||<|0.001|2-Sided|95.0|1.19|2.5||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682683|NCT01216163|3094609|Superiority or Other||LS mean difference|0.49|||<|0.071|2-Sided|95.0|-0.04|1.03||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682684|NCT01216163|3094609|Superiority or Other||LS mean difference|2.34|||<|0.001|2-Sided|95.0|1.68|2.99||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682685|NCT01216163|3094609|Superiority or Other||LS mean difference|0.57|||<|0.011|2-Sided|95.0|0.13|1.02||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682686|NCT01216163|3094609|Superiority or Other||LS mean difference|0.27|||<|0.148|2-Sided|95.0|-0.1|0.63||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682687|NCT01216163|3094609|Superiority or Other||LS mean difference|0.84|||<|0.001|2-Sided|95.0|0.4|1.28||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682688|NCT01216163|3094610|Superiority or Other||LS mean difference|0.56||||0.005|2-Sided|95.0|0.17|0.94||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682689|NCT01216163|3094610|Superiority or Other||LS mean difference|0.38||||0.02|2-Sided|95.0|0.06|0.69||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682690|NCT01216163|3094610|Superiority or Other||LS mean difference|0.93|||<|0.001|2-Sided|95.0|0.54|1.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682691|NCT01216163|3094610|Superiority or Other||LS mean difference|0.65|||<|0.001|2-Sided|95.0|0.27|1.03||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682692|NCT01216163|3094610|Superiority or Other||LS mean difference|0.28|||<|0.084|2-Sided|95.0|-0.04|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682693|NCT01216163|3094610|Superiority or Other||LS mean difference|0.92|||<|0.001|2-Sided|95.0|0.54|1.31||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682694|NCT01216163|3094610|Superiority or Other||LS mean difference|0.82|||<|0.001|2-Sided|95.0|0.44|1.19||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682695|NCT01216163|3094610|Superiority or Other||LS mean difference|0.45|||<|0.004|2-Sided|95.0|0.15|0.76||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682696|NCT01216163|3094610|Superiority or Other||LS mean difference|1.27|||<|0.001|2-Sided|95.0|0.89|1.65||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682697|NCT01216163|3094610|Superiority or Other||LS mean difference|0.87|||<|0.001|2-Sided|95.0|0.49|1.24||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682773|NCT01215955|3094637|Superiority or Other||LS Mean Difference|6.72||||0.095|2-Sided|95.0|-1.17|14.6||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682698|NCT01216163|3094610|Superiority or Other||LS mean difference|0.42|||<|0.007|2-Sided|95.0|0.12|0.73||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682699|NCT01216163|3094610|Superiority or Other||LS mean difference|1.29|||<|0.001|2-Sided|95.0|0.91|1.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682700|NCT01216163|3094610|Superiority or Other||LS mean difference|1.12|||<|0.001|2-Sided|95.0|0.78|1.46||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682701|NCT01216163|3094610|Superiority or Other||LS mean difference|0.31|||<|0.03|2-Sided|95.0|0.03|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682702|NCT01216163|3094610|Superiority or Other||LS mean difference|1.43|||<|0.001|2-Sided|95.0|1.09|1.78||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682703|NCT01216163|3094610|Superiority or Other||LS mean difference|1.11|||<|0.001|2-Sided|95.0|0.8|1.42||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682704|NCT01216163|3094610|Superiority or Other||LS mean difference|0.32|||<|0.014|2-Sided|95.0|0.07|0.58||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682705|NCT01216163|3094610|Superiority or Other||LS mean difference|1.43|||<|0.001|2-Sided|95.0|1.12|1.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682706|NCT01216163|3094610|Superiority or Other||LS mean difference|0.97|||<|0.001|2-Sided|95.0|0.68|1.26||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682707|NCT01216163|3094610|Superiority or Other||LS mean difference|0.33|||<|0.006|2-Sided|95.0|0.09|0.57||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682708|NCT01216163|3094610|Superiority or Other||LS mean difference|1.3|||<|0.001|2-Sided|95.0|1.01|1.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682709|NCT01216163|3094610|Superiority or Other||LS mean difference|0.64|||<|0.001|2-Sided|95.0|0.38|0.9||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682710|NCT01216163|3094610|Superiority or Other||LS mean difference|0.25|||<|0.019|2-Sided|95.0|0.04|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682711|NCT01216163|3094610|Superiority or Other||LS mean difference|0.89|||<|0.001|2-Sided|95.0|0.64|1.15||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682712|NCT01216163|3094610|Superiority or Other||LS mean difference|0.25|||<|0.007|2-Sided|95.0|0.07|0.42||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682713|NCT01216163|3094610|Superiority or Other||LS mean difference|0.06|||<|0.387|2-Sided|95.0|-0.08|0.21||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682774|NCT01215955|3094637|Superiority or Other||LS Mean Difference|1.15||||0.543|2-Sided|95.0|-2.55|4.84||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682714|NCT01216163|3094610|Superiority or Other||LS mean difference|0.31|||<|0.001|2-Sided|95.0|0.13|0.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682715|NCT01216163|3094611|Superiority or Other||LS mean difference|0.98||||0.002|2-Sided|95.0|0.38|1.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682716|NCT01216163|3094611|Superiority or Other||LS mean difference|0.47||||0.061|2-Sided|95.0|-0.02|0.97||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682717|NCT01216163|3094611|Superiority or Other||LS mean difference|1.46|||<|0.001|2-Sided|95.0|0.85|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682718|NCT01216163|3094611|Superiority or Other||LS mean difference|1.12|||<|0.001|2-Sided|95.0|0.52|1.71||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682719|NCT01216163|3094611|Superiority or Other||LS mean difference|0.42|||<|0.088|2-Sided|95.0|-0.06|0.91||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682720|NCT01216163|3094611|Superiority or Other||LS mean difference|1.54|||<|0.001|2-Sided|95.0|0.95|2.14||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682721|NCT01216163|3094611|Superiority or Other||LS mean difference|1.35|||<|0.001|2-Sided|95.0|0.77|1.93||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682722|NCT01216163|3094611|Superiority or Other||LS mean difference|0.63|||<|0.01|2-Sided|95.0|0.15|1.1||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682723|NCT01216163|3094611|Superiority or Other||LS mean difference|1.97|||<|0.001|2-Sided|95.0|1.39|2.56||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682724|NCT01216163|3094611|Superiority or Other||LS mean difference|1.51|||<|0.001|2-Sided|95.0|0.95|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682725|NCT01216163|3094611|Superiority or Other||LS mean difference|0.59|||<|0.013|2-Sided|95.0|0.13|1.05||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682726|NCT01216163|3094611|Superiority or Other||LS mean difference|2.1|||<|0.001|2-Sided|95.0|1.53|2.66||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682727|NCT01216163|3094611|Superiority or Other||LS mean difference|1.81|||<|0.001|2-Sided|95.0|1.29|2.32||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682728|NCT01216163|3094611|Superiority or Other||LS mean difference|0.51|||<|0.019|2-Sided|95.0|0.08|0.93||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682729|NCT01216163|3094611|Superiority or Other||LS mean difference|2.31|||<|0.001|2-Sided|95.0|1.8|2.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682775|NCT01215955|3094638|Superiority or Other||LS Mean Difference|9.01||||0.037|2-Sided|95.0|0.53|17.49||P-value is for 0300 hours. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682730|NCT01216163|3094611|Superiority or Other||LS mean difference|1.88|||<|0.001|2-Sided|95.0|1.43|2.34||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682731|NCT01216163|3094611|Superiority or Other||LS mean difference|0.37|||<|0.055|2-Sided|95.0|-0.01|0.74||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682732|NCT01216163|3094611|Superiority or Other||LS mean difference|2.25|||<|0.001|2-Sided|95.0|1.79|2.7||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682733|NCT01216163|3094611|Superiority or Other||LS mean difference|1.63|||<|0.001|2-Sided|95.0|1.21|2.06||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682734|NCT01216163|3094611|Superiority or Other||LS mean difference|0.44|||<|0.014|2-Sided|95.0|0.09|0.78||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682735|NCT01216163|3094611|Superiority or Other||LS mean difference|2.07|||<|0.001|2-Sided|95.0|1.64|2.49||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682736|NCT01216163|3094611|Superiority or Other||LS mean difference|1.2|||<|0.001|2-Sided|95.0|0.77|1.63||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682737|NCT01216163|3094611|Superiority or Other||LS mean difference|0.24|||<|0.178|2-Sided|95.0|-0.11|0.59||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682738|NCT01216163|3094611|Superiority or Other||LS mean difference|1.44|||<|0.001|2-Sided|95.0|1.01|1.87||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682739|NCT01216163|3094611|Superiority or Other||LS mean difference|0.33|||<|0.029|2-Sided|95.0|0.03|0.62||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Acetaminophen - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682740|NCT01216163|3094611|Superiority or Other||LS mean difference|0.2|||<|0.101|2-Sided|95.0|-0.04|0.44||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Acetaminophen) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682741|NCT01216163|3094611|Superiority or Other||LS mean difference|0.53|||<|0.001|2-Sided|95.0|0.24|0.83||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1682742|NCT01216163|3094612|Superiority or Other||Hazard Ratio (HR)|11.81|||<|0.001|2-Sided|95.0|5.06|27.59||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1682743|NCT01216163|3094612|Superiority or Other||Hazard Ratio (HR)|1.19|||<|0.323|2-Sided|95.0|0.84|1.68||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1682744|NCT01216163|3094612|Superiority or Other||Hazard Ratio (HR)|14.06|||<|0.001|2-Sided|95.0|6.02|32.8||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1682745|NCT01216163|3094613|Superiority or Other||Hazard Ratio (HR)|10.43|||<|0.001|2-Sided|95.0|4.5|24.17||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.|
1682776|NCT01215955|3094638|Superiority or Other||LS Mean Difference|11.18||||0.02|2-Sided|95.0|1.74|20.63||P-value is for Bed Time. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682746|NCT01216163|3094613|Superiority or Other||Hazard Ratio (HR)|1.14|||<|0.468|2-Sided|95.0|0.81|1.6||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.|
1682747|NCT01216163|3094613|Superiority or Other||Hazard Ratio (HR)|11.84|||<|0.001|2-Sided|95.0|5.13|27.36||p-value was calculated using PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.|
1682748|NCT01216163|3094614|Superiority or Other||LS mean difference|12.71|||<|0.001|2-Sided|95.0|8.12|17.3||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Acetaminophen - Placebo) and 95% CI: based on LS means from ANOVA. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.|
1682749|NCT01216163|3094614|Superiority or Other||LS mean difference|4.96|||<|0.01|2-Sided|95.0|1.21|8.72||p-value was calculated using ANOVA model with treatment, baseline PSR, gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Ibuprofen sodium - Acetaminophen) and 95% CI: based on LS means from ANOVA. Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:IBU Na vs PBO, IBU Na vs APAP, APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.|
1682750|NCT01216163|3094614|Superiority or Other||Least-squares (LS) mean difference|17.68|||<|0.001|2-Sided|95.0|13.08|22.27||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR), gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference(Ibuprofen sodium - placebo) and 95 percent(%) confidence interval(CI):based on LS means from Analysis of Variance(ANOVA).Type I error controlled at 5% significance level(2-sided) by testing co-primary endpoints sequentially:Ibuprofen sodium(IBU Na) versus(vs) Placebo(PBO), IBU Na vs Acetaminophen(APAP), APAP vs PBO for SPRID 0-6 then time to meaningful relief at each comparison.If comparison at preceding step was significant only then subsequent comparisons were significant.|
1682751|NCT01215968|3094631|Superiority or Other||Ratio of Geometric LS Mean|1.84|||||2-Sided|90.0|1.52|2.22|||||||
1682752|NCT01215968|3094631|Superiority or Other||Ratio of Geometric LS Mean|1.91|||||2-Sided|90.0|1.59|2.29|||||||
1682753|NCT01215968|3094631|Superiority or Other||Ratio of Geometric LS Mean|1.94|||||2-Sided|90.0|1.61|2.33|||||||
1682754|NCT01215968|3094631|Superiority or Other||Ratio of Geometric LS Mean|2.19|||||2-Sided|90.0|1.83|2.62|||||||
1682755|NCT01215955|3094632|Superiority or Other|||||||0.856||||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic||||
1682756|NCT01215955|3094632|Superiority or Other|||||||0.258||||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic||||
1682757|NCT01215955|3094633|Superiority or Other||Q3D vs Q1D Ratio Negative Binomial|1.05||||0.689|2-Sided|95.0|0.84|1.3||Comparison is calculated as Q3D versus Q1D.|Negative Binomial||||
1682758|NCT01215955|3094633|Superiority or Other||Q3D vs Q1D Ratio of Negative Binomial|1.06||||0.586|2-Sided|95.0|0.86|1.3||Comparison is calculated as Q3D versus Q1D.|Negative Binomial Regression||||
1682759|NCT01215955|3094634|Superiority or Other|||||||0.205||||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic||||
1682760|NCT01215955|3094634|Superiority or Other|||||||0.802||||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic||||
1682761|NCT01215955|3094635|Superiority or Other|||||||0.351||||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic||||
1682762|NCT01215955|3094635|Superiority or Other|||||||0.435||||||Comparison is calculated as Q3D versus Q1D.|Regression, Logistic||||
1682763|NCT01215955|3094636|Superiority or Other||LS Mean Difference|0.06||||0.245|2-Sided|95.0|-0.04|0.15||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682764|NCT01215955|3094636|Superiority or Other||LS Mean Difference|0.03||||0.194|2-Sided|95.0|-0.02|0.08||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682765|NCT01215955|3094636|Superiority or Other||LS Mean Difference|0.02||||0.275|2-Sided|95.0|-0.01|0.05||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|LS Mean Difference||||
1682766|NCT01215955|3094636|Superiority or Other||LS Mean Difference|0.1|||<|0.001|2-Sided|95.0|0.05|0.16||P-value is for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682767|NCT01215955|3094636|Superiority or Other||LS Mean Difference|0.07|||<|0.037|2-Sided|95.0|0.0|0.14||P-value is for bolus insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682768|NCT01215955|3094636|Superiority or Other||Mean Difference (Final Values)|0.01|||<|0.442|2-Sided|95.0|-0.02|0.05||P-value is for basal insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|LS Mean Difference||||
1682769|NCT01215955|3094637|Superiority or Other||LS Mean Difference|6.05||||0.222|2-Sided|95.0|-3.67|15.76||P-value of for total insulin dose. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682779|NCT01215955|3094638|Superiority or Other||LS Mean Difference|6.22||||0.045|2-Sided|95.0|0.14|12.29||P-value is for Midday Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682780|NCT01215955|3094638|Superiority or Other||LS Mean Difference|4.38||||0.198|2-Sided|95.0|-2.3|11.06||P-value is for Morning 2-hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682781|NCT01215955|3094638|Superiority or Other||LS Mean Difference|2.1||||0.415|2-Sided|95.0|-2.96|7.15||P-value is for Morning Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682782|NCT01215955|3094638|Superiority or Other||LS Mean Difference|2.37||||0.519|2-Sided|95.0|-4.86|9.6||P-value is for 0300 hours. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682783|NCT01215955|3094638|Superiority or Other||LS Mean Difference|-2.25||||0.617|2-Sided|95.0|-11.08|6.58||P-value is for Bed Time. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682784|NCT01215955|3094638|Superiority or Other||LS Mean Difference|3.38||||0.322|2-Sided|95.0|-3.32|10.07||P-value is for Evening Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682785|NCT01215955|3094638|Superiority or Other||LS Mean Difference|-3.48||||0.358|2-Sided|95.0|-10.91|3.95||P-value is for Midday 2-Hr PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682786|NCT01215955|3094638|Superiority or Other||LS Mean Difference|1.42||||0.626||95.0|-4.32|7.16||P-value is for Midday Pre-Meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682787|NCT01215955|3094638|Superiority or Other||LS Mean Difference|-0.71||||0.842|2-Sided|95.0|-7.71|6.29||P-value is for Morning 2-HR PP. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682788|NCT01215955|3094638|Superiority or Other||LS Mean Difference|3.32||||0.245|2-Sided|95.0|-2.28|8.93||P-value is for Morning Pre-meal. No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682789|NCT01215955|3094639|Superiority or Other||LS Mean Differences|-0.28||||0.495|2-Sided|95.0|-1.08|0.52||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model||
1682790|NCT01215955|3094639|Superiority or Other||LS Mean Differences|-0.15||||0.723|2-Sided|95.0|-0.95|0.66||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model||
1682791|NCT01215955|3094640|Superiority or Other||LS Mean Differences|1.13||||0.082|2-Sided|95.0|-0.15|2.41||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without 24-week values were handled by the statistical model.||
1682792|NCT01215955|3094640|Superiority or Other||LS Mean Differences|0.59||||0.242|2-Sided|95.0|-0.4|1.58||Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||No imputation was performed. Participants without a 24-week value were handled by the statistical model.||
1682793|NCT01215955|3094641|Superiority or Other||LS Mean Differences|0.81|||||2-Sided|95.0|0.3|1.31|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.||
1682794|NCT01215955|3094641|Superiority or Other||LS Mean Differences|0.29|||||2-Sided|95.0|-0.19|0.77|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.||
1682795|NCT01215955|3094642|Superiority or Other||Hazard Ratio (HR)|0.89||||0.46|2-Sided|95.0|0.65|1.22||Comparison is calculated as Q3D versus Q1D.|Regression, Cox|Cox Regression model with effects for treatment and baseline stratification variables (HbA1c, country, sulfonylurea/meglitinide use) was used.|||
1682796|NCT01215955|3094642|Superiority or Other||Hazard Ratio (HR)|0.8||||0.182|2-Sided|95.0|0.57|1.11||Comparison is calculated as Q3D versus Q1D.|Regression, Cox|Cox Regression model with effects for treatment and baseline stratification variables (HbA1c, country, sulfonylurea/meglitinide use) was used.|||
1682797|NCT01215955|3094643|Superiority or Other||LS Mean Differences|-0.5||||0.108|2-Sided|95.0|-1.12|0.11||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682798|NCT01215955|3094643|Superiority or Other||LS Mean Differences|0.81||||0.014|2-Sided|95.0|0.17|1.46||No imputation was performed. Participants without a 24-week value were handled by the statistical model. Comparison is calculated as Q3D versus Q1D.|Mixed Models Analysis||||
1682799|NCT01215955|3094644|Superiority or Other||Odds Ratio (OR)|0.43||||0.078|2-Sided|95.0|0.17|1.1||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or >8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic||||
1682800|NCT01215955|3094644|Superiority or Other||Odds Ratio (OR)|0.32||||0.015|2-Sided|95.0|0.13|0.8||P-value is for HbA1c ≤7% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or >8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic|Included treatment and effects for baseline stratification variables: Baseline HbA1c (≤8% or >8%), country and sulfonylurea/meglitinide use.|||
1682840|NCT01215175|3094808|Other||Risk Difference (RD)|3.6||||||95.0|-15.5|22.9|||||Miettinen & Nurminen method||
1682841|NCT01215175|3094808|Other||Risk Difference (RD)|8.2||||||95.0|-7.9|26.6|||||Miettinen & Nurminen method||
1682801|NCT01215955|3094644|Superiority or Other||Odds Ratio (OR)|1.62||||0.249|2-Sided|95.0|0.71|3.7||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or >8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic||||
1682802|NCT01215955|3094644|Superiority or Other||Odds Ratio (OR)|1.17||||0.701|2-Sided|95.0|0.52|2.67||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or >8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic||||
1682803|NCT01215955|3094645|Superiority or Other||Odds Ratio (OR)|0.93||||0.723|2-Sided|95.0|0.61|1.4||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or >8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Linear||||
1682804|NCT01215955|3094645|Superiority or Other||Odds Ratio (OR)|0.77||||0.162|2-Sided|95.0|0.53|1.11||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or >8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic||||
1682805|NCT01215955|3094645|Superiority or Other||Odds Ratio (OR)|0.9||||0.625|2-Sided|95.0|0.58|1.39||P-value is for HbA1c ≤6.5% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or >8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic||||
1682806|NCT01215955|3094645|Superiority or Other||Odds Ratio (OR)|0.75||||0.128|2-Sided|95.0|0.52|1.09||P-value is for HbA1c ≤7.0% at endpoint (LOCF). Logistic regression included treatment and effects for baseline stratification variables: baseline HbA1c (≤8% or >8%), country and sulfonylurea/meglitinide use. Comparison calculated as Q3D versus Q1D.|Regression, Logistic||||
1682807|NCT01215955|3094646|Superiority or Other||LS Mean Difference|0.06|||||2-Sided|95.0|-0.12|0.24|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model.||
1682808|NCT01215955|3094646|Superiority or Other||LS Mean Difference|0.04|||||2-Sided|95.0|-0.15|0.22|||||No imputation was performed. Participants without a 24-week value were handled by the statistical model.||
1682809|NCT01215695|3094681|Superiority|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1682810|NCT01215695|3094682|Superiority|||||||0.05|||||||Chi-squared||||
1682811|NCT01215695|3094683|Superiority|||||||0.05|||||||Chi-squared||||
1682812|NCT01215695|3094684|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1682813|NCT01215695|3094685|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1682814|NCT01215435|3094709|Superiority or Other||Estimated treatment difference, Mean|-3.14||||0.6215||95.0|-15.65|9.37|||Regression, Linear||||
1682815|NCT01215435|3094710|Non-Inferiority or Equivalence|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval for the mean HbA1c treatment difference was below or equal to 0.4%. This is equivalent to using a one-sided test of size 2.5%.|Estimated treatment difference, Mean|-0.14|||<|0.001||95.0|-0.4|0.13|||Regression, Linear|||H0: D > 0.4% against H1: D ≤ 0.4% where D is the mean treatment difference for change in HbA1c (pre-breakfast OD minus pre-dinner OD)|
1682816|NCT01215422|3094712|Superiority or Other||R-squared|0.16|||>|0.05||95.0||||Correlation between years of experience (all anesthesiologists, pooled) and time to intubation (both GS and KS VLSs, pooled)|Correlation||||
1682817|NCT01215422|3094715|Superiority or Other|||||||0.03||||||The p-value represents the comparison of the two interventions combined and compared against baseline for Grades III and IV summed together.|Fisher Exact||||
1682818|NCT01215422|3094716|Superiority or Other||Odds Ratio (OR)|2.0|||>|0.05|1-Sided|95.0|0.15||||Regression, Logistic||||
1682819|NCT01215292|3094725|Superiority or Other||||||<|0.05|||||||Kruskal-Wallis||||
1682820|NCT01215292|3094726|Superiority or Other||||||<|0.05|||||||Kruskal-Wallis||||
1682821|NCT01215292|3094727|Non-Inferiority or Equivalence|80% power to detect 20% difference in ITT|||||<|0.05|||||||Kruskal-Wallis||||
1682822|NCT01215253|3094758|Superiority||Hazard Ratio (HR)|0.74||||0.414|2-Sided|95.0|0.36|1.52|||Anderdon-Gill analysis||||
1682823|NCT01215253|3094759|Superiority||Hazard Ratio (HR)|1.01||||0.947|2-Sided|95.0|0.73|1.41|||Regression, Cox||||
1682824|NCT01215253|3094760|Superiority||Hazard Ratio (HR)|0.73||||0.038|2-Sided|95.0|0.55|0.98|||Regression, Cox||||
1682825|NCT01215253|3094761|Superiority|||||||0.948|||||||nonparametric Wilcoxon rank-sum test||||
1682826|NCT01215253|3094762|Superiority|||||||0.508|||||||nonparametric Wilcoxon rank-sum test||||
1682827|NCT01215253|3094763|Superiority||Hazard Ratio (HR)|0.97||||0.871|2-Sided|95.0|0.69|1.37|||Regression, Cox||||
1682828|NCT01215253|3094764|Superiority||Hazard Ratio (HR)|1.07||||0.577|2-Sided|95.0|0.84|1.37|||Regression, Cox||||
1682829|NCT01215253|3094765|Superiority||Hazard Ratio (HR)|1.1||||0.316|2-Sided|95.0|0.91|1.34|||Regression, Cox||||
1682830|NCT01215253|3094766|Superiority||Hazard Ratio (HR)|0.75||||0.398|2-Sided|95.0|0.38|1.47|||Regression, Cox||||
1682831|NCT01215253|3094767|Superiority||Hazard Ratio (HR)|0.7||||0.028|2-Sided|95.0|0.51|0.96|||Anderson-Gill analysis||||
1682832|NCT01215253|3094768|Superiority||Hazard Ratio (HR)|0.98||||0.891|2-Sided|95.0|0.76|1.26|||Regression, Cox||||
1682833|NCT01215253|3094769|Superiority||Hazard Ratio (HR)|0.84||||0.117|2-Sided|95.0|0.67|1.05|||Regression, Cox||||
1682834|NCT01215175|3094804|Other||Risk Difference (RD)|3.6||||||95.0|-19.1|26.0|||||Miettinen & Nurminen method||
1682835|NCT01215175|3094804|Other||Risk Difference (RD)|9.8||||||95.0|-10.6|30.9|||||Miettinen & Nurminen method||
1682836|NCT01215175|3094805|Other||Risk Difference (RD)|10.0||||||95.0|-7.4|28.3|||||Miettinen & Nurminen method||
1682837|NCT01215175|3094806|Other||Risk Difference (RD)|0.0||||||95.0|-12.3|12.3|||||Miettinen & Nurminen method||
1682838|NCT01215175|3094806|Other||Risk Difference (RD)|0.0||||||95.0|-12.2|10.6|||||Miettinen & Nurminen method||
1682839|NCT01215175|3094807|Other||Risk Difference (RD)|0.0||||||95.0|-11.5|11.5|||||Miettinen & Nurminen method||
1682843|NCT01215097|3094823|Superiority or Other||Odds Ratio (OR)|3.054|||<|0.0001||95.0|1.799|5.185|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with HbA1c at least lowering 0.5% from baseline|
1682844|NCT01215097|3094824|Superiority or Other||Odds Ratio (OR)|4.97||||0.0129||95.0|1.404|17.592|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c >= 6.5%|
1682845|NCT01215097|3094826|Superiority or Other||Odds Ratio (OR)|6.243|||<|0.0001||95.0|2.831|13.769|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c >=7.0%|
1682846|NCT01215097|3094828|Superiority or Other||Adjusted mean difference|-11.5|Standard Error of the Mean|4.0||0.0044||95.0|-19.5|-3.6|||ANCOVA||||
1682847|NCT01215097|3094829|Superiority or Other||Adjusted mean difference|-10.2|Standard Error of the Mean|3.6||0.005||95.0|-17.3|-3.1|||ANCOVA||||
1682848|NCT01215097|3094830|Superiority or Other||Adjusted mean difference|-22.1|Standard Error of the Mean|3.3|<|0.0001||95.0|-28.7|-15.6|||ANCOVA||||
1682849|NCT01215097|3094831|Superiority or Other||Adjusted mean difference|-9.6|Standard Error of the Mean|4.2||0.0233||95.0|-17.8|-1.3|||ANCOVA||||
1682850|NCT01215097|3094832|Superiority or Other||Adjusted mean difference|-0.52|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.71|-0.32|||ANCOVA||||
1682851|NCT01215097|3094833|Superiority or Other||Adjusted mean difference|-0.53|Standard Error of the Mean|0.09|<|0.0001||95.0|-0.7|-0.35|||ANCOVA||||
1682852|NCT01215097|3094834|Superiority or Other||Adjusted mean difference|-0.591|Standard Error of the Mean|0.082|<|0.0001||95.0|-0.752|-0.43|||ANCOVA||||
1682853|NCT01215097|3094835|Superiority or Other||Adjusted mean difference|-0.433|Standard Error of the Mean|0.062|<|0.0001|2-Sided|95.0|-0.555|-0.311|||ANCOVA||||
1682854|NCT01215097|3094836|Superiority or Other||Adjusted mean difference|-0.52|Standard Error of the Mean|0.09|<|0.0001||95.0|-0.7|-0.34|||ANCOVA||||
1682855|NCT01214850|3094884|Superiority or Other||Odds Ratio (OR)|0.84|||||2-Sided|95.0|0.555|1.273||||||Vaccine Group Odds Ratios for carriage of combined N. meningitidis serogroups A, C, W, Y in the MenACWY-CRM group compared to Control group at 1 month after receiving 1 injection of MenACWY vaccine|
1682856|NCT01214850|3094885|Superiority or Other||Odds Ratio (OR)|1.185||||0.3828|2-Sided|95.0|0.809|1.737|||Regression, Logistic|||Vaccine Group Odds Ratios for carriage of virulent ST strain of N. meningitidis group B in 4CMenB group as compared to the control group at 1 month after receiving the 2nd rMenB+OMV NZ vaccination|
1682857|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.89|||||2-Sided|95.0|0.7|1.13||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.|
1682858|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.77|||||2-Sided|95.0|0.62|0.97||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.|
1682859|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.07|||||2-Sided|95.0|0.86|1.32||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.|
1682860|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.0|||||2-Sided|95.0|0.82|1.22||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.|
1682861|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.97|||||2-Sided|95.0|0.77|1.21||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.|
1682862|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||2-Sided|95.0|0.83|1.27||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.|
1682863|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.1|||||2-Sided|95.0|0.89|1.36||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.|
1682864|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.72|||||2-Sided|95.0|0.59|0.87||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.|
1682865|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||2-Sided|95.0|0.83|1.3||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.|
1682866|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.03|||||2-Sided|95.0|0.84|1.27||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.|
1682867|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.07|||||2-Sided|95.0|0.87|1.31||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.|
1682868|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.79|||||2-Sided|95.0|0.66|0.96||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.|
1682869|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||2-Sided|95.0|0.87|1.25||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.|
1682870|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.8|||||2-Sided|95.0|0.67|0.95||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.|
1682871|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.04|||||2-Sided|95.0|0.83|1.3||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.|
1682872|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.85|||||2-Sided|95.0|0.69|1.05||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.|
1682873|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.1|||||2-Sided|95.0|0.88|1.37||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.|
1682874|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.85|||||2-Sided|95.0|0.69|1.04||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.|
1682875|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5|GMC ratio|1.07|||||2-Sided|95.0|0.89|1.29||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.|
1682876|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||2-Sided|95.0|0.86|1.21||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.|
1682877|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|0.94|||||2-Sided|95.0|0.75|1.18||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.|
1682878|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.77|||||2-Sided|95.0|0.62|0.96||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.|
1682927|NCT01214239|3094981|Superiority or Other||Adjusted mean difference|-9.5|Standard Error of the Mean|3.8||0.0135||95.0|-17.0|-2.0|||ANCOVA||||
1682879|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.25|||||2-Sided|95.0|1.01|1.55||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.|
1682880|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|1.14|||||2-Sided|95.0|0.93|1.4||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.|
1682881|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between the groups (MenACWY4 to routine vaccines) is greater than 0.5.|GMC ratio|1.02|||||2-Sided|95.0|0.83|1.25||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.|
1682882|NCT01214837|3094889|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI around the ratio of GMCs between groups (MenACWY3 to routine vaccines) is greater than 0.5.|GMC ratio|0.94|||||2-Sided|95.0|0.77|1.13||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.|
1682883|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.5|||||2-Sided|95.0|-1.4|10.5||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.|
1682884|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|1.9|||||2-Sided|95.0|-4.2|8.2||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.|
1682885|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||2-Sided|95.0|-2.1|3.4||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.|
1682886|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||2-Sided|95.0|-1.7|3.4||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.|
1682887|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-5.5|||||2-Sided|95.0|-11.3|-0.9||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.|
1682888|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.5|||||2-Sided|95.0|-7.1|1.6||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.|
1682889|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.2|||||2-Sided|95.0|-6.2|0.2||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.|
1682890|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.5|||||2-Sided|95.0|-6.3|-0.2||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.|
1682924|NCT01214239|3094976|Superiority or Other||Odds Ratio (OR)|1.583||||0.25||95.0|0.724|3.46|||Regression, Logistic|||Comparison by odds ratio for the patients with a baseline HbA1c >= 6.5%|
1682891|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|2.5|||||2-Sided|95.0|-0.2|6.3||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.|
1682892|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|vaccine group difference|1.9|||||2-Sided|95.0|-1.2|5.7||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.|
1682893|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.0|||||2-Sided|95.0|-1.5|9.7||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.|
1682894|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-3.1|||||2-Sided|95.0|-9.7|3.4||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.|
1682895|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||2-Sided|95.0|-2.1|3.5||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.|
1682896|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.6|||||2-Sided|95.0|-1.7|3.5||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.|
1682897|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|10.2|||||2-Sided|95.0|3.4|17.2||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.|
1682898|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-0.3|||||2-Sided|95.0|-8.4|7.7||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.|
1682899|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|1.2|||||2-Sided|95.0|-2.2|4.8||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.|
1682900|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.04|||||2-Sided|95.0|-3.7|3.8||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.|
1682901|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|4.9|||||2-Sided|95.0|-1.9|11.8||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.|
1682925|NCT01214239|3094978|Superiority or Other||Odds Ratio (OR)|2.552||||0.0021||95.0|1.407|4.629|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication||Comparison by odds ratio for the patients with a baseline HbA1c >= 7.0%|
1682926|NCT01214239|3094980|Superiority or Other||Adjusted mean difference|-9.6|Standard Error of the Mean|3.8||0.0113||95.0|-17.1|-2.2|||ANCOVA||||
1682902|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-4.3|||||2-Sided|95.0|-12.1|3.4||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.|
1682903|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|0.3|||||2-Sided|95.0|-4.4|4.7||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.|
1682904|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-2.4|||||2-Sided|95.0|-7.5|2.3||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.|
1682905|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|5.3|||||2-Sided|95.0|-3.3|13.7||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.|
1682906|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-3.0|||||2-Sided|95.0|-11.9|6.0||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.|
1682907|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY4 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|5.8|||||2-Sided|95.0|3.0|10.5||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.|
1682908|NCT01214837|3094890|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the between group difference (MenACWY3 minus Routine) in percentage of subjects with IgG concentration ≥ 0.35 μg/mL against each pneumococcal anti-capsular polysaccharide is greater than -10%.|Vaccine group difference|-0.5|||||2-Sided|95.0|-6.1|5.0||||||To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.|
1682909|NCT01214837|3094897|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|1.0|||||2-Sided|95.0|-2.0|4.0||||||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup Y at 13 months of age.|
1682910|NCT01214837|3094897|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|0.0|||||2-Sided|95.0|-3.0|3.0||||||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup W at 13 months of age.|
1682911|NCT01214837|3094897|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|-4.0|||||2-Sided|95.0|-8.0|0.0||||||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup C at 13 months of age.|
1682912|NCT01214837|3094897|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups C, W and Y between the 3-dose series and (minus) the 4-dose series, is greater than -10%.|Vaccine group difference|-7.0|||||2-Sided|95.0|-14.0|-1.0||||||Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup A at 13 months of age.|
1682913|NCT01214824|3094900|Superiority or Other|||||||0.5304|||||||Paired t-test|||Comparison is masked phase 2 versus masked phase 1|
1682914|NCT01214824|3094902|Superiority or Other||Median Difference (Final Values)|-0.3||||0.014||95.0|||||Wilcoxon signed rank test|||Comparison is HbA1c at 6 months versus Baseline|
1682915|NCT01214720|3094909|Superiority or Other||Hazard Ratio (HR)|0.89||||0.2087||95.0|0.74|1.07|||Log Rank||||
1682916|NCT01214720|3094910|Superiority or Other||Difference in Response Rates|3.62||||0.3621|2-Sided|95.0|-4.3|11.6|||Chi-squared|Approximate 95% confidence interval (CI) for difference of two rates using Hauck-Anderson method.|||
1682928|NCT01214239|3094982|Superiority or Other||Adjusted mean difference|-8.8|Standard Error of the Mean|3.3||0.0086||95.0|-15.4|-2.3|||ANCOVA||||
1682929|NCT01214239|3094983|Superiority or Other||Adjusted mean difference|-11.2|Standard Error of the Mean|3.1||0.0003||95.0|-17.2|-5.2|||ANCOVA||||
1682930|NCT01214239|3094984|Superiority or Other||Adjusted mean difference|-0.46|Standard Error of the Mean|0.12||0.0001||95.0|-0.69|-0.23|||ANCOVA||||
1682931|NCT01214239|3094985|Superiority or Other||Adjusted mean difference|-0.512|Standard Error of the Mean|0.098|<|0.0001||95.0|-0.705|-0.318|||ANCOVA||||
1682932|NCT01214239|3094986|Superiority or Other||Adjusted mean difference|-0.5|Standard Error of the Mean|0.09|<|0.0001||95.0|-0.677|-0.323|||ANCOVA||||
1682933|NCT01214239|3094987|Superiority or Other||Adjusted mean difference|-0.383|Standard Error of the Mean|0.074|<|0.0001||95.0|-0.527|-0.238|||ANCOVA||||
1682934|NCT01214239|3094988|Superiority or Other||Adjusted mean difference|-0.5|Standard Error of the Mean|0.11|<|0.0001||95.0|-0.71|-0.28|||ANCOVA||||
1682935|NCT01214200|3094996|Other|For the analysis of differences between pre and post treatment a student’s t-test was used and was checked with the Wilcoxon signed rank test. A p<0.05 was considered statistically significant.||||||0.01|||||||Wilcoxon Signed Ranks Test||||
1682936|NCT01214187|3094997|Superiority||Mean Difference (Net)|-0.58|Standard Error of the Mean|2.42||0.8124|2-Sided||||||ANOVA|Repeated measure ANOVA|||
1682937|NCT01214187|3094998|Superiority or Other||Mean Difference (Net)|-48.46|Standard Error of the Mean|18.14||0.0099|2-Sided||||||ANOVA|Repeated measure ANOVA|Difference=(Change from baseline to week 12 for CO group) minus (Change from baseline to week 12 for placebo group)||
1682938|NCT01214187|3094999|Superiority||Mean Difference (Net)|0.64|Standard Error of the Mean|1.93||0.7401|2-Sided||||||ANOVA|Repeated Measure ANOVA|difference=(change from baseline to week 12 for CO group) minus (change from baseline to week 12 for placebo group)||
1682939|NCT01214187|3095000|Superiority||Mean Difference (Net)|-0.85|Standard Error of the Mean|1.57||0.5882|2-Sided||||||ANOVA|Repeated Measure ANOVA|Difference = (Change from baseline to week 12 for CO group) minus (Change from baseline to week 12 for placebo group)||
1682940|NCT01214187|3095001|Superiority||Mean Difference (Net)|-1.04|Standard Error of the Mean|0.81||0.2072|2-Sided||||||ANOVA|Repeated measure ANOVA|Difference = (Change from baseline to Week 12 for Carbon monoxide group) minus (Change from baseline to Week 12 for Placebo group)||
1682941|NCT01214109|3095022|Superiority or Other||Ratio of geometric least squares means|95.05||||||90.0|84.88|106.43||||||0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment|
1682942|NCT01214109|3095022|Superiority or Other||Ratio of geometric least squares means|92.84||||||90.0|83.8|102.86||||||0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment|
1682943|NCT01214109|3095023|Superiority or Other||Ratio of geometric least squares means|91.97||||||90.0|60.07|140.25||||||0.5 mg t.i.d. IR vs. 1.5 mg q.d. ER 0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment|
1682944|NCT01214109|3095023|Superiority or Other||Ratio of geometric least squares means|88.82||||||90.0|79.89|98.76||||||0.125 mg t.i.d. IR vs. 0.375 mg q.d. ER 0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment|
1682945|NCT01214109|3095024|Superiority or Other||Ratio of geometric least squares means|89.37||||||90.0|81.16|98.42||||||0.5 mg t.i.d. IR vs. 1.5 mg q.d. ER 0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment|
1682946|NCT01214109|3095024|Superiority or Other||Ratio of geometric least squares means|88.01||||||90.0|80.76|95.92||||||0.125 mg t.i.d. IR vs. 0.375 mg q.d. ER 0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment|
1682947|NCT01214109|3095025|Superiority or Other||Ratio of geometric least squares means|96.17||||||90.0|69.33|133.42||||||0.5 mg t.i.d. IR is the reference treatment, 1.5 mg q.d. ER is the test treatment|
1682948|NCT01214109|3095025|Superiority or Other||Ratio of geometric least squares means|82.62||||||90.0|74.45|91.69||||||0.125 mg t.i.d. IR is the reference treatment, 0.375 mg q.d. ER is the test treatment|
1682949|NCT01214044|3095035|Other|Spearman's rank-order correlation (non-parametric test) was used.||||||0.48||||||Spearman's rho (rs) = 0.02|Spearman's rank-order correlation|||We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Beck Depression Inventory-II score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.|
1682950|NCT01214044|3095035|Other|Spearman's rank-order correlation (non-parametric test) was used.||||||0.06||||||Spearman's rho (rs) = 0.66|Spearman's rank-order correlation|||We hypothesized that there would be a correlation between the change in phase angle difference and the decrease in the Hamilton-21 score with escitalopram treatment. The phase angle difference is the interval, in hours, between the dim light melatonin onset (a marker of biological time) and the average midpoint of sleep during the prior week.|
1682951|NCT01214044|3095036|Other|A paired t-test was done to see if the Beck Depression Inventory-II score decreased from baseline to post-treatment.||||||0.14||||||A priori threshold for significance was p = 0.05.|t-test, 1 sided|paired t-test||"We hypothesized that there would be a decrease in the Beck Depression Inventory-II score with escitalopram treatment.~A within subjects comparison was done to compare the Beck Depression Inventory-II score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11)."|
1682952|NCT01214044|3095037|Other|A paired t-test was done to see if the Hamilton-21 score decreased from baseline to post-treatment.||||||0.01||||||A priori threshold for significance was p = 0.05.|t-test, 1 sided|paired t-test||"We hypothesized that there would be a decrease in the Hamilton-21 score with escitalopram treatment.~A within subjects comparison was done to compare the Hamilton-21 score before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11)."|
1682953|NCT01214044|3095038|Other|A paired t-test was done to see if the time of the dim light melatonin onset changed from baseline to post-treatment.||||||0.2||||||A priori threshold for significance was p = 0.05.|t-test, 2 sided|paired t-test||A within subjects comparison was done to compare the time of the dim light melatonin onset before treatment with escitalopram (Study Visit 3) and after treatment with escitalopram (Study Visit 11).|
1683117|NCT01212445|3095289|Superiority or Other||Mean Difference (Final Values)|-1.302||||0.8109|2-Sided|95.0|-12.059|9.454|||ANCOVA||||
1682954|NCT01213966|3095039|Superiority or Other|||||||0.01||||||PPR24 was summarized descriptively. No statistical test was performed. The PRR24 values were summarised when the corresponding regression fit had a p-value of p ≤0.01 and an adjusted coefficient of determination (R2) ≥0.85.|Regression, Linear|||PPR24 was summarised descriptively. No statistical test was performed.|
1682955|NCT01213043|3095128|Non-Inferiority or Equivalence|Equivalence margin was: [0.80, 1.25]|Geometric Least Square Means Ratio|0.85|||<|0.0001|2-Sided|90.0|0.83|0.88|||ANOVA|||Dose proportionality was analysed using an ANOVA model for the natural log-transformed AUC0-7days with treatment, period, and sequence as fixed effects and subject within sequence as a random effect. The treatment dose of 60 mg/kg was the reference treatment and 120 mg/kg was the test treatment. PK parameters in individual subjects for each treatment dose were dose normalized to 60mg/kg based on the actual dose administered at Week 8 or Week 18 (i.e., (AUC0-7days/Actual Dose in mg/kg)*60mg/kg).|
1682956|NCT01212991|3095133|Superiority or Other (legacy)||Difference in objective response rate|53.85|||<|0.0001||95.0|48.53|59.17||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.05 for this analysis.|Cochran-Mantel-Haenszel||||
1682957|NCT01212991|3095134|Superiority or Other (legacy)||Difference in response rates|74.51|||<|0.0001||95.0|71.45|77.57||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.025 for this analysis.|Cochran-Mantel-Haenszel||||
1682958|NCT01212991|3095135|Superiority or Other (legacy)||Hazard Ratio (HR)|0.169|||<|0.0001||95.0|0.147|0.195||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0167 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with < 1 favoring enzalutamide.||
1682959|NCT01212991|3095136|Superiority or Other (legacy)||Hazard Ratio (HR)|0.349|||<|0.0001||95.0|0.303|0.403||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.0125 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with < 1 favoring enzalutamide.||
1682960|NCT01212991|3095137|Superiority or Other (legacy)||Hazard Ratio (HR)|0.718|||<|0.0001||95.0|0.61|0.844||The Holm step down method of multiple comparisons was used to maintain a study wide type I error of 5% for prespecified secondary efficacy analyses. The 2-sided type I error rate was 0.01 for this analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with < 1 favoring enzalutamide.||
1682961|NCT01212991|3095138|Superiority or Other (legacy)||Hazard Ratio (HR)|0.186|||<|0.0001|2-Sided|95.0|0.149|0.231||The assigned 2-sided type I error rate was 0.001 for the analysis of radiographic progression-free survival.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with < 1 favoring enzalutamide.||
1682962|NCT01212991|3095139|Superiority or Other (legacy)||Hazard Ratio (HR)|0.706|||<|0.0001|2-Sided|95.0|0.596|0.837||A 2-stage group sequential method (Lan DeMets OBF) assigned the level of significance for the pre-specified interim overall survival analysis (p<0.015) based on overall 2-sided type I error rate of 0.049. Final results based upon interim analysis.|Log Rank||The hazard ratio is based on an unstratified Cox regression model (with treatment as the only covariate) and is relative to placebo with <1 favoring enzalutamide.||
1682963|NCT01212952|3095143|Other||Maximum Tolerated Dose (MTD) (mg/m^2)|1.3|||||2-Sided||||||||Maximum Tolerated Dose Level is Dose Level 2 (1.3 mg/m^2 Bortezomib).||
1682964|NCT01212874|3095145|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1682965|NCT01212874|3095146|Superiority or Other|||||||0.21|||||||t-test, 2 sided||||
1682966|NCT01212770|3095167|Superiority||Adjusted Difference|9.6||||0.252|2-Sided|95.0|-6.2|25.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682967|NCT01212770|3095167|Superiority||Adjusted Difference|9.8||||0.2321|2-Sided|95.0|-5.8|25.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682968|NCT01212770|3095168|Superiority||Adjusted Difference|-7.7||||0.2032|2-Sided|95.0|-19.3|3.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682969|NCT01212770|3095168|Superiority||Adjusted Difference|-0.4||||0.9463|2-Sided|195.0|-12.1|11.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682970|NCT01212770|3095169|Superiority||Adjusted Difference|6.4||||0.437|2-Sided|95.0|-9.1|21.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1683072|NCT01212757|3095239|Superiority||LS Mean Difference|0.1||||0.6777|2-Sided|95.0|-0.6|0.8|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1682971|NCT01212770|3095169|Superiority||Adjusted Difference|6.6||||0.4175|2-Sided|95.0|-8.6|21.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682972|NCT01212770|3095170|Superiority||Adjusted Difference|-5.4||||0.3547|2-Sided|95.0|-16.6|5.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682973|NCT01212770|3095170|Superiority||Adjusted Difference|-4.1||||0.4707|2-Sided|95.0|-14.8|6.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682974|NCT01212770|3095171|Superiority||Adjusted Difference|0.6||||0.787|2-Sided|95.0|-3.5|4.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682975|NCT01212770|3095171|Superiority||Adjusted Difference|1.8||||0.423|2-Sided|95.0|-2.6|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682976|NCT01212770|3095172|Superiority||Adjusted Difference|5.8||||0.0807|2-Sided|95.0|-0.6|12.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682977|NCT01212770|3095172|Superiority||Adjusted Difference|8.3||||0.018|2-Sided|95.0|1.6|15.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682978|NCT01212770|3095173|Superiority||Adjusted Difference|2.3||||0.2527|2-Sided|95.0|-1.5|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682979|NCT01212770|3095173|Superiority||Adjusted Difference|1.2||||0.5154|2-Sided|95.0|-2.4|4.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682980|NCT01212770|3095174|Superiority||Adjusted Difference|4.2||||0.2052|2-Sided|95.0|-2.2|10.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682981|NCT01212770|3095174|Superiority||Adjusted Difference|6.8||||0.052|2-Sided|95.0|0.0|13.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682982|NCT01212770|3095175|Superiority||Adjusted Difference|11.7||||0.0123|2-Sided|95.0|2.7|20.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682983|NCT01212770|3095175|Superiority||Adjusted Difference|22.5|||<|0.0001|2-Sided|95.0|13.0|32.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682984|NCT01212770|3095176|Superiority||Adjusted Difference|7.2||||0.3695|2-Sided|95.0|-8.2|22.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1683073|NCT01212757|3095239|Superiority||LS Mean Difference|-0.3||||0.3705|2-Sided|95.0|-1.0|0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1682985|NCT01212770|3095176|Superiority||Adjusted Difference|12.2||||0.1172|2-Sided|95.0|-2.5|26.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682986|NCT01212770|3095177|Superiority||Adjusted Difference|1.0||||0.8876|2-Sided|95.0|-12.6|14.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682987|NCT01212770|3095177|Superiority||Adjusted Difference|3.8||||0.5731|2-Sided|95.0|-9.1|16.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682988|NCT01212770|3095178|Superiority||Adjusted Difference|11.0||||0.0309|2-Sided|95.0|1.2|20.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682989|NCT01212770|3095178|Superiority||Adjusted Difference|22.5|||<|0.0001|2-Sided|95.0|12.4|32.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682990|NCT01212770|3095179|Superiority||Adjusted Difference|7.5||||0.361|2-Sided|95.0|-8.3|23.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682991|NCT01212770|3095179|Superiority||Adjusted Difference|12.0||||0.1303|2-Sided|95.0|-3.1|27.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD useinvolvement of >= 3% BSA with psoriasis at baseline..|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682992|NCT01212770|3095180|Superiority||Adjusted Difference|-3.9||||0.5808|2-Sided|95.0|-17.4|9.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682993|NCT01212770|3095180|Superiority||Adjusted Difference|2.1||||0.7585|2-Sided|95.0|-10.9|15.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use and involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1682994|NCT01212770|3095181|Superiority||LS Mean Difference|1.19||||0.1936|2-Sided|95.0|-0.61|2.98|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1682995|NCT01212770|3095181|Superiority||LS Mean Difference|2.44||||0.0078|2-Sided|95.0|0.64|4.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1682996|NCT01212770|3095182|Superiority||LS Mean Difference|-0.3||||0.0147|2-Sided|95.0|-0.54|-0.06|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1682997|NCT01212770|3095182|Superiority||LS Mean Difference|-0.48||||0.0001|2-Sided|95.0|-0.72|-0.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1682998|NCT01212770|3095183|Superiority||LS Mean Difference|-2.65||||0.0349|2-Sided|95.0|-5.11|-0.19|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1682999|NCT01212770|3095183|Superiority||LS Mean Difference|-5.27|||<|0.0001|2-Sided|95.0|-7.73|-2.82|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683000|NCT01212770|3095184|Superiority||LS Mean Difference|-0.4||||0.4413|2-Sided|95.0|-1.3|0.6|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683001|NCT01212770|3095184|Superiority||LS Mean Difference|-1.0||||0.0399|2-Sided|95.0|-1.9|0.0|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683002|NCT01212770|3095185|Superiority||LS Mean Difference|-0.3||||0.5012|2-Sided|95.0|-1.1|0.6|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683003|NCT01212770|3095185|Superiority||LS Mean Difference|-0.4||||0.2761|2-Sided|95.0|-1.3|0.4|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683004|NCT01212770|3095186|Superiority||LS Mean Difference|-3.8||||0.1218|2-Sided|95.0|-8.6|1.0|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683005|NCT01212770|3095186|Superiority||LS mean Difference|-6.6||||0.008|2-Sided|95.0|-11.4|-1.7|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683006|NCT01212770|3095187|Superiority||Adjusted Difference|10.8||||0.0515|2-Sided|95.0|0.1|21.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1683007|NCT01212770|3095187|Superiority||Adjusted Difference|14.8||||0.0099|2-Sided|95.0|3.8|25.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1683008|NCT01212770|3095188|Superiority||Adjusted Difference|8.7||||0.0661|2-Sided|95.0|-0.5|18.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1683009|NCT01212770|3095188|Superiority||Adjusted Difference|21.2|||<|0.0001|2-Sided|95.0|11.5|30.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use and and involvement of >= 3% BSA with psoriasis at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1683010|NCT01212770|3095189|Superiority||LS Mean Difference|1.67||||0.0404|2-Sided|95.0|0.07|3.27|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683011|NCT01212770|3095189|Superiority||LS Mean Difference|2.34||||0.0043|2-Sided|95.0|0.74|3.94|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683012|NCT01212770|3095190|Superiority||LS Mean Difference|0.68||||0.4505|2-Sided|95.0|-1.09|2.44|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683013|NCT01212770|3095190|Superiority||LS Mean Difference|2.54||||0.0049|2-Sided|95.0|0.77|4.3|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683014|NCT01212770|3095191|Superiority||LS Mean Difference|-0.27||||0.0237|2-Sided|95.0|-0.5|-0.04|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683015|NCT01212770|3095191|Superiority||LS Mean Difference|-0.47||||0.0001|2-Sided|95.0|-0.7|-0.24|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683016|NCT01212770|3095192|Superiority||LS Mean Difference|-1.85||||0.1325|2-Sided|95.0|-4.27|0.56|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683017|NCT01212770|3095192|Superiority||LS Mean Difference|-4.94||||0.0001|2-Sided|95.0|-7.34|-2.53|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683018|NCT01212770|3095193|Superiority||LS Mean Difference|-0.4||||0.3641|2-Sided|95.0|-1.3|0.5|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683019|NCT01212770|3095193|Superiority||LS Mean Difference|-0.8||||0.072|2-Sided|95.0|-1.7|0.1|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683020|NCT01212770|3095194|Superiority||LS Mean Difference|0.1||||0.8231|2-Sided|95.0|-0.7|0.9|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683021|NCT01212770|3095194|Superiority||LS Mean Difference|-0.2||||0.5349|2-Sided|95.0|-1.0|0.5|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.|||
1683022|NCT01212770|3095195|Superiority||LS Mean Difference|-3.6||||0.1482|2-Sided|95.0|-8.6|1.3|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683023|NCT01212770|3095195|Superiority||LS Mean Difference|-7.8||||0.0021|2-Sided|95.0|-12.8|-2.9|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683024|NCT01212770|3095196|Superiority||Adjusted Difference|13.0||||0.0134|2-Sided|95.0|3.0|23.1|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683114|NCT01212445|3095288|Superiority or Other||Mean Difference (Final Values)|12.886||||0.0486|2-Sided|95.0|0.078|25.695|||ANCOVA||||
1683025|NCT01212770|3095196|Superiority||Adjusted Difference|14.6||||0.0062|2-Sided|95.0|4.5|24.8|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across 2 strata of baseline DMARD use with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683026|NCT01212770|3095197|Superiority||Adjusted Difference|10.4||||0.0372|2-Sided|95.0|0.8|20.0|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683027|NCT01212770|3095197|Superiority or Other (legacy)||Adjusted Difference|25.4|||<|0.0001|2-Sided|95.0|15.5|35.3|||Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683028|NCT01212770|3095198|Superiority||LS mean Difference|1.15||||0.1658|2-Sided|95.0|-0.48|2.77|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683029|NCT01212770|3095198|Superiority||LS Mean Difference|2.32||||0.0053|2-Sided|95.0|0.69|3.95|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683030|NCT01212770|3095199|Superiority||LS Mean Difference|-0.084||||0.086|2-Sided|95.0|-0.181|0.012|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683031|NCT01212770|3095199|Superiority||LS Mean Difference|-0.139||||0.005|2-Sided|95.0|-0.236|-0.042|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683032|NCT01212770|3095200|Superiority||Adjusted Difference|11.1||||0.011|2-Sided|95.0|2.7|19.5||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1683033|NCT01212770|3095200|Superiority||Adjusted Difference|15.5||||0.0007|2-Sided|95.0|6.7|24.3||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|Two-sided p-value based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.||
1683034|NCT01212770|3095201|Superiority||LS Mean Difference|-0.066||||0.1619|2-Sided|95.0|-0.158|0.027|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.|
1683035|NCT01212770|3095201|Superiority||LS Mean Difference|-0.127||||0.0073|2-Sided|95.0|-0.22|-0.034|||ANCOVA|Based on an ANCOVA model with treatment group, baseline DMARD use and ≥ 3% BSA psoriasis involvement as factors and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.|
1683050|NCT01212757|3095228|Superiority||Adjusted Difference|3.1||||0.057|2-Sided|95.0|0.0|6.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683051|NCT01212757|3095228|Superiority||Adjusted Difference|0.6||||0.562|2-Sided|95.0|-1.5|2.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683036|NCT01212770|3095202|Superiority or Other (legacy)||Adjusted Difference|9.8||||0.0295|2-Sided|95.0|1.1|18.6|||Cochran-Mantel-Haenszel|2-sided p-value based on the Cochran-Mantel-Haenszel test adjusting for baseline DMARD use and ≥ 3% BSA psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.|
1683037|NCT01212770|3095202|Superiority or Other (legacy)||Adjusted Difference|22.3|||<|0.0001|2-Sided|95.0|13.0|31.6|||Cochran-Mantel-Haenszel|Adjusted for baseline disease modifying antirheumatic drug (DMARD) use and and ≥ 3% body surface area (BSA) psoriasis involvement at baseline.|Adjusted difference is the weighted average of the treatment differences across 4 strata of baseline DMARD use by ≥ 3% BSA psoriasis involvement at baseline with the CMH weights. The 95% CI is based on a normal approximation to the weighted average.|The percentage of participants with an ACR20 response was compared using a Cochran-Mantel- Haenszel (CMH) test. The Hochberg procedure was used to maintain the Type 1 error at the 0.05 significance level. The results were considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.|
1683038|NCT01212757|3095222|Superiority||Adjusted Difference|3.3||||0.6965|2-Sided|95.0|-13.3|19.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683039|NCT01212757|3095222|Superiority||Adjusted Difference|5.9||||0.4811|2-Sided|95.0|-10.3|22.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683040|NCT01212757|3095223|Superiority||Adjusted Difference|5.9||||0.3395|2-Sided|95.0|-6.0|17.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683041|NCT01212757|3095223|Superiority||Adjusted Difference|-1.2||||0.8424|2-Sided|95.0|-12.7|10.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683042|NCT01212757|3095224|Superiority||Adjusted Difference|1.9||||0.8205|2-Sided|95.0|-14.3|18.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683043|NCT01212757|3095224|Superiority||Adjusted Difference|0.3||||0.9698|2-Sided|95.0|-16.0|16.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683044|NCT01212757|3095225|Superiority||Adjusted Difference|5.9||||0.3305|2-Sided|95.0|-5.9|17.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683045|NCT01212757|3095225|Superiority||Adjusted Difference|-2.2||||0.7023|2-Sided|95.0|-13.5|9.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683046|NCT01212757|3095226|Superiority||Adjusted Difference|2.4||||0.2929|2-Sided|95.0|-2.0|6.8|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683047|NCT01212757|3095226|Superiority||Adjusted Difference|-0.6||||0.7273|2-Sided|95.0|-4.3|3.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683048|NCT01212757|3095227|Superiority||Adjusted Difference|5.4||||0.1323|2-Sided|95.0|-1.5|12.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683049|NCT01212757|3095227|Superiority||Adjusted Difference|3.1||||0.3629|2-Sided|95.0|-3.5|9.6|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683071|NCT01212757|3095238|Superiority||LS Mean Difference|-3.14||||0.0097|2-Sided|95.0|-5.52|-0.76|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683052|NCT01212757|3095229|Superiority||Adjusted Difference|9.8||||0.0034|2-Sided|95.0|3.4|16.1|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683053|NCT01212757|3095229|Superiority||Adjusted Difference|5.6||||0.0589|2-Sided|95.0|-0.2|11.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683054|NCT01212757|3095230|Superiority||Adjusted Difference|20.5||||0.0001|2-Sided|95.0|10.8|30.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683055|NCT01212757|3095230|Superiority||Adjusted Difference|12.1||||0.0142|2-Sided|95.0|2.6|21.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683056|NCT01212757|3095231|Superiority||Adjusted Difference|6.8||||0.3941|2-Sided|95.0|-8.7|22.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683057|NCT01212757|3095231|Superiority||Adjusted Difference|6.8||||0.3959|2-Sided|95.0|-8.7|22.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683058|NCT01212757|3095232|Superiority||Adjusted Difference|6.1||||0.3756|2-Sided|95.0|-7.2|19.4|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683059|NCT01212757|3095232|Superiority||Adjusted Difference|6.6||||0.3376|2-Sided|95.0|-6.8|20.0|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683060|NCT01212757|3095233|Superiority||Adjusted Difference|22.1||||0.0001|2-Sided|95.0|11.7|32.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683061|NCT01212757|3095233|Superiority||Adjusted Difference|17.5||||0.0014|2-Sided|95.0|7.0|27.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683062|NCT01212757|3095234|Superiority||Adjusted Difference|3.3||||0.6881|2-Sided|95.0|-12.7|19.3|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683063|NCT01212757|3095234|Superiority||Adjusted Difference|2.8||||0.7337|2-Sided|95.0|-13.3|18.9|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683064|NCT01212757|3095235|Superiority||Adjusted Difference|1.3||||0.8462|2-Sided|95.0|-12.1|14.7|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights.||
1683065|NCT01212757|3095235|Superiority||Adjusted Difference|3.6||||0.6022|2-Sided|95.0|-9.9|17.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights.||
1683066|NCT01212757|3095236|Superiority||LS mean Difference|0.16||||0.8704|2-Sided|95.0|-1.76|2.08|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683067|NCT01212757|3095236|Superiority||LS Mean Difference|2.14||||0.0303|2-Sided|95.0|0.2|4.07|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683068|NCT01212757|3095237|Superiority||LS Mean Difference|-0.45||||0.0001|2-Sided|95.0|-0.68|-0.23|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683069|NCT01212757|3095237|Superiority||LS Mean Difference|-0.38||||0.0011|2-Sided|95.0|-0.6|-0.15|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683070|NCT01212757|3095238|Superiority||LS Mean Difference|-4.5||||0.0002|2-Sided|95.0|-6.85|-2.16|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683115|NCT01212445|3095289|Superiority or Other||Mean Difference (Final Values)|-0.772||||0.885|2-Sided|95.0|-11.329|9.784|||ANCOVA||||
1683074|NCT01212757|3095240|Superiority||LS Mean Difference|0.0||||0.9727|2-Sided|95.0|-0.8|0.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683075|NCT01212757|3095240|Superiority or Other (legacy)||LS Mean Difference|-0.4||||0.2719|2-Sided|95.0|-1.2|0.3|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683076|NCT01212757|3095241|Superiority or Other (legacy)||LS mean Difference|-3.5||||0.1762|2-Sided|95.0|-8.5|1.6|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683077|NCT01212757|3095241|Superiority or Other (legacy)||LS Mean Difference|-1.7||||0.5067|2-Sided|95.0|-6.8|3.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683078|NCT01212757|3095242|Superiority||Adjusted Difference|15.5||||0.0026|2-Sided|95.0|5.6|25.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683079|NCT01212757|3095242|Superiority||Adjusted Difference|7.8||||0.1195|2-Sided|95.0|-1.9|17.5||The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Cochran-Mantel-Haenszel||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683080|NCT01212757|3095243|Superiority or Other (legacy)||LS Mean Difference|1.53||||0.0997|2-Sided|95.0|-0.29|3.35|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683081|NCT01212757|3095243|Superiority or Other (legacy)||LS Mean Difference|1.86||||0.0473|2-Sided|95.0|0.02|3.7|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683082|NCT01212757|3095244|Superiority or Other (legacy)||LS Mean Difference|0.27||||0.7803|2-Sided|95.0|-1.65|2.2|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683083|NCT01212757|3095244|Superiority or Other (legacy)||LS Mean Difference|2.12||||0.0318|2-Sided|95.0|0.19|4.06|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683084|NCT01212757|3095245|Superiority or Other (legacy)||LS Mean Difference|-0.47|||<|0.0001|2-Sided|95.0|-0.68|-0.25|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683085|NCT01212757|3095245|Superiority or Other (legacy)||LS Mean Difference|-0.4|||<|0.0004|2-Sided|95.0|-0.61|-0.18|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683086|NCT01212757|3095246|Superiority or Other (legacy)||LS Mean Difference|-4.45||||0.0002|2-Sided|95.0|-6.76|-2.14|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683087|NCT01212757|3095246|Superiority or Other (legacy)||LS Mean Difference|-3.51||||0.0035|2-Sided|95.0|-5.86|-1.16|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683088|NCT01212757|3095247|Superiority or Other (legacy)||LS Mean Difference|0.3||||0.3759|2-Sided|95.0|-0.4|1.0|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683089|NCT01212757|3095247|Superiority or Other (legacy)||LS Mean Difference|-0.2||||0.5438|2-Sided|95.0|-1.0|0.5|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683090|NCT01212757|3095248|Superiority||LS Mean Difference|0.1||||0.8874|2-Sided|95.0|-0.7|0.8|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683091|NCT01212757|3095248|Superiority or Other (legacy)||LS Mean Difference|-0.4||||0.3496|2-Sided|95.0|-1.2|0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683092|NCT01212757|3095249|Superiority or Other (legacy)||LS Mean Difference|-5.5||||0.0347|2-Sided|95.0|-10.6|-0.4|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683093|NCT01212757|3095249|Superiority or Other (legacy)||LS Mean Difference|-4.9||||0.0648|2-Sided|95.0|-10.0|0.3|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1683094|NCT01212757|3095250|Superiority||Adjusted Difference|14.7||||0.0071|2-Sided|95.0|4.1|25.2|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683095|NCT01212757|3095250|Superiority or Other (legacy)||Adjusted Difference|14.9||||0.0065|2-Sided|95.0|4.3|25.5|||Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683116|NCT01212445|3095289|Superiority or Other||Mean Difference (Final Values)|-2.075||||0.6995|2-Sided|95.0|-12.693|8.544|||ANCOVA||||
1683096|NCT01212757|3095251|Superiority||LS Mean Difference|1.36||||0.1388|2-Sided|95.0|-0.44|3.15|||ANCOVA||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|
1683097|NCT01212757|3095251|Superiority||LS Mean Difference|2.1||||0.0237|2-Sided|95.0|0.28|3.92|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above|
1683098|NCT01212757|3095252|Superiority||LS Mean Difference|-0.08||||0.1179|2-Sided|95.0|-0.18|0.02|||ANCOVA||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683099|NCT01212757|3095252|Superiority or Other (legacy)||LS Mean Difference|-0.121||||0.0191|2-Sided|95.0|-0.222|-0.02|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|
1683100|NCT01212757|3095253|Superiority or Other (legacy)||Adjusted Difference|15.7||||0.0009|2-Sided|95.0|6.7|24.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683101|NCT01212757|3095253|Superiority or Other (legacy)||Adjusted Difference|9.2||||0.0394|2-Sided|95.0|0.5|17.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1683102|NCT01212757|3095254|Superiority or Other (legacy)||LS Mean Difference|-0.104||||0.032|2-Sided|95.0|-0.199|-0.009|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.|
1683103|NCT01212757|3095254|Superiority or Other (legacy)||LS Mean Difference|-0.14||||0.0042|2-Sided|95.0|-0.236|-0.045|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.|
1683104|NCT01212757|3095255|Superiority or Other (legacy)||Adjusted Difference|18.7||||0.0002|2-Sided|95.0|9.1|28.2|||Cochran-Mantel-Haenszel|2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.|
1683105|NCT01212757|3095255|Superiority or Other (legacy)||Adjusted Difference|13.4||||0.006|2-Sided|95.0|4.0|22.7|||Cochran-Mantel-Haenszel|2-sided p-value is based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline disease modifying antirheumatic drug (DMARD) use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% confidence interval (CI) is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.|
1683106|NCT01212445|3095286|Superiority or Other||Mean Difference (Final Values)|0.172||||0.467|2-Sided|95.0|-0.293|0.637|||ANCOVA||||
1683107|NCT01212445|3095286|Superiority or Other||Mean Difference (Final Values)|-0.139||||0.553|2-Sided|95.0|-0.602|0.323|||ANCOVA||||
1683108|NCT01212445|3095286|Superiority or Other||Mean Difference (Final Values)|-0.311||||0.1865|2-Sided|95.0|-0.774|0.152|||ANCOVA||||
1683109|NCT01212445|3095287|Superiority or Other||Mean Difference (Final Values)|-0.803||||0.8685|2-Sided|95.0|-10.397|8.79|||ANCOVA||||
1683110|NCT01212445|3095287|Superiority or Other||Mean Difference (Final Values)|2.887||||0.5546|2-Sided|95.0|-6.765|12.539|||ANCOVA||||
1683111|NCT01212445|3095287|Superiority or Other||Mean Difference (Final Values)|3.69||||0.4591|2-Sided|95.0|-6.153|13.534|||ANCOVA||||
1683112|NCT01212445|3095288|Superiority or Other||Mean Difference (Final Values)|-11.641||||0.0744|2-Sided|95.0|-24.449|1.167|||ANCOVA||||
1683113|NCT01212445|3095288|Superiority or Other||Mean Difference (Final Values)|1.245||||0.8465|2-Sided|95.0|-11.471|13.962|||ANCOVA||||
1683118|NCT01212445|3095290|Superiority or Other||Mean Difference (Final Values)|-6.046||||0.2941|2-Sided|95.0|-17.412|5.32|||ANCOVA||||
1683119|NCT01212445|3095290|Superiority or Other||Mean Difference (Final Values)|1.706||||0.768|2-Sided|95.0|-9.729|13.141|||ANCOVA||||
1683120|NCT01212445|3095290|Superiority or Other||Mean Difference (Final Values)|7.752||||0.1876|2-Sided|95.0|-3.834|19.338|||ANCOVA||||
1683121|NCT01212445|3095291|Superiority or Other||Odds Ratio (OR)|1.6|||||2-Sided|95.0|0.424|6.043||||||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."|
1683122|NCT01212445|3095291|Superiority or Other||Odds Ratio (OR)|2.233|||||2-Sided|95.0|0.628|7.94||||||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."|
1683123|NCT01212445|3095291|Superiority or Other||Treatment Success Rate|0.118||||0.7746|2-Sided|95.0|0.044|0.239|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher’s).|
1683124|NCT01212445|3095291|Superiority or Other||Treatment Success Rate|0.157||||0.5256|2-Sided|95.0|0.07|0.286|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher’s).|
1683125|NCT01212445|3095291|Superiority or Other||Treatment Success Rate|0.077||||0.235|2-Sided|95.0|0.021|0.185|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher’s).|
1683126|NCT01212445|3095293|Superiority or Other||Odds Ratio (OR)|1.024|||||2-Sided|95.0|0.386|2.72||||||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 39.375 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence intervals. There were no multiplicity adjustments."|
1683127|NCT01212445|3095293|Superiority or Other||Odds Ratio (OR)|1.92|||||2-Sided|95.0|0.774|4.763||||||"Logistic regression analysis was performed with treatment success as the dichotomous dependent variable and dose (13.125g, 26.25g, or 39.375 g) as the independent variable. The main effects for the model were tested for significance at the 5% level.~The odds of response for the 26.25 g dose level versus the 13.125 g dose level were presented together with the associated 95% confidence interval. There were no multiplicity adjustments."|
1683128|NCT01212445|3095293|Superiority or Other||Treatment Success Rate|0.196||||0.2558|2-Sided|95.0|0.098|0.331|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher’s).|
1683129|NCT01212445|3095293|Superiority or Other||Treatment Success Rate|0.314||||1|2-Sided|95.0|0.191|0.459|||Fisher Exact|||The treatment success rate was calculated as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher’s).|
1683130|NCT01212445|3095293|Superiority or Other||Treatment Success Rate|0.192||||0.179|2-Sided|95.0|0.096|0.325|||Fisher Exact|||The treatment success rate was defined as the number of participants in a treatment group with treatment successes (BM with no straining or hard/lumpy stools) divided by the total number of participants in the treatment group. Treatment success rate was calculated for each dose group along with 95% confidence intervals (CI) based on exact binomial statistics. Treatment success rates were compared between each pair of treatments using an exact 2-sided test (Fisher’s).|
1683131|NCT01212172|3095298|Superiority or Other||Mean Difference (Final Values)|7.9||||0.2879|2-Sided|95.0|-6.7|21.1|||t-test, 1 sided||||
1683132|NCT01212159|3095301|Superiority or Other|||||||0.391||||||Comparison of mean reduction in LDL cholesterol between no monitor (control) and monitor (intervention) groups|t-test, 2 sided|||Paired t-test analysis of 6 month change in LDL cholesterol for no monitor and self monitor groups Independent sample t-test to compare ldl change between groups|
1683133|NCT01211873|3095321|Superiority||||||<|0.001|||||||Regression, Logistic||||
1683134|NCT01211873|3095321|Superiority||||||<|0.001|||||||Regression, Logistic||||
1683135|NCT01211873|3095322|Superiority||||||<|0.001|||||||Regression, Logistic||||
1683136|NCT01211873|3095322|Superiority||||||<|0.001|||||||Regression, Logistic||||
1683137|NCT01211873|3095323|Superiority||||||<|0.001|||||||Regression, Logistic||||
1683138|NCT01211769|3095324|Superiority or Other||Variance (F)|1.08||||0.37||95.0|||||ANOVA|||GROUP COMPARISON|
1683139|NCT01211769|3095324|Superiority or Other||||||<|0.001|||||||ANOVA|||TIME COMPARISON|
1683142|NCT01211769|3095326|Superiority or Other||Variance (F)|0.71||||0.69||95.0|||||ANOVA|||GROUP COMPARISON|
1683143|NCT01211769|3095326|Superiority or Other||||||<|0.001|||||||ANOVA|||TIME COMPARISON|
1683144|NCT01211730|3095340|Superiority or Other|||||||0.77|||||||Chi-squared, Corrected||||
1683145|NCT01211730|3095341|Superiority or Other|||||||0.56|||||||Chi-squared, Corrected||||
1683146|NCT01211730|3095342|Superiority or Other|||||||0.75|||||||Chi-squared, Corrected||||
1683147|NCT01211730|3095343|Superiority or Other|||||||0.0046|||||||Chi-squared, Corrected||||
1683148|NCT01211730|3095344|Superiority or Other|||||||0.003|||||||Chi-squared, Corrected||||
1683149|NCT01211730|3095345|Superiority or Other|||||||0.709|||||||Chi-squared, Corrected||||
1683150|NCT01211613|3095356|Superiority or Other|||||||0.002||||||The p value above relates to the comparison of differences in baseline/4-week Numeric pain change scores between manual and mechanical manipulation methods (secondary hypothesis). A priori threshold for statistical significance was set at p < 0.05.|Regression, Linear|Linear regression model was adjusted for these covariates: baseline Numeric pain score, age, and treatment expectancy.|||
1683151|NCT01211613|3095357|Superiority or Other||Mean Difference (Final Values)|10.0|Standard Deviation|14.0||0.009|2-Sided|95.0||||The p value above relates to the comparison of differences in baseline/4-week Oswestry change scores between manual and mechanical manipulation methods (primary hypothesis). A priori threshold for statistical significance was set at p < 0.05.|Regression, Linear|Linear regression model was adjusted for these covariates: baseline Oswestry score, age, and treatment expectancy.|||
1683152|NCT01211340|3095382|Superiority or Other|||||||0.89|||||||Regression, Linear|||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.|
1683153|NCT01211340|3095382|Superiority or Other|||||||0.89|||||||Wilcoxon (Mann-Whitney)|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.|
1683154|NCT01211340|3095383|Superiority or Other|||||||0.15|||||||Regression, Linear|||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.|
1683155|NCT01211340|3095383|Superiority or Other|||||||0.15|||||||Wilcxon Rank Sum Test|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.|
1683156|NCT01211340|3095384|Superiority or Other|||||||0.18|||||||Spearmans rank|No differences found||To test the effects of the dose of meetings on association with overall Caregiver Perceptions of Pain Medicine Questionaire (CPMQ) change we used Spearman rank correlation coefficient|
1683157|NCT01211340|3095384|Superiority or Other|||||||0.18|||||||Regression, Linear|No significant difference found between groups||The secondary analysis used a linear mixed model to test for groups differences over time. To account for repeated- measures nature of the data and the varying duration of participation, both participant specific intercept and slopes were treated as random effects. To minimize the leverage of relatively small number of participants with extremely long follow-up times we limited the number of days followed to 122, which was the 75th percentile of the days in the combined study.|
1683158|NCT01211340|3095384|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||The first analysis examined change from baseline to last available measure prior to death or the end of the study. The pre/post change was calculated for each participant and the Wilcoxon rank sum test was used to compare usual care and intervention groups with respect to changes. All randomized caregivers with at least 1 post baseline measure were included in the analysis.|
1683159|NCT01211197|3095398|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|75.13|Standard Deviation|24.5|||2-Sided|90.0|63.68|88.64|||||Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted|
1683160|NCT01211197|3095398|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|103.49|Standard Deviation|12.7|||2-Sided|90.0|95.3|112.39|||||Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted|
1683161|NCT01211197|3095399|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.67|Standard Deviation|13.7|||2-Sided|90.0|91.7|110.51|||||Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted|
1683162|NCT01211197|3095399|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|102.15|Standard Deviation|13.0|||2-Sided|90.0|93.87|111.15|||||Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted|
1683163|NCT01211197|3095400|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|96.96|Standard Deviation|15.5|||2-Sided|90.0|87.23|107.78|||||Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted|
1683164|NCT01211197|3095400|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|103.13|Standard Deviation|11.7|||2-Sided|90.0|95.59|111.25|||||Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted|
1683308|NCT01208233|3095761|Superiority or Other||Odds Ratio (OR)|0.854||||0.7234|2-Sided|80.0|0.48|1.51|||Regression, Logistic|||LOCF was used to impute missing data.|
1683165|NCT01211197|3095401|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|94.39|Standard Deviation|8.2|||2-Sided|90.0|89.22|99.87|||||Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted|
1683166|NCT01211197|3095401|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.94|Standard Deviation|7.7|||2-Sided|90.0|96.03|106.11|||||Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted|
1683167|NCT01211197|3095402|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|64.3|Standard Deviation|20.6|||2-Sided|90.0|55.97|73.87|||||Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted|
1683168|NCT01211197|3095402|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|99.31|Standard Deviation|12.2|||2-Sided|90.0|91.76|107.49|||||Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fasted divided by individual tablets fasted|
1683169|NCT01211197|3095403|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|94.94|Standard Deviation|8.0|||2-Sided|90.0|89.85|100.33|||||Standard deviation is actually the intra-individual gCV.|Ratio calculated as FDC fed divided by FDC fasted|
1683170|NCT01211197|3095403|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|100.59|Standard Deviation|7.6|||2-Sided|90.0|95.75|105.67|||||Standard deviation is actually the intra-individual geometric coefficient of variation (gCV).|Ratio calculated as FDC fasted divided by individual tablets fasted.|
1683171|NCT01211145|3095406|Superiority or Other||Odds Ratio (OR)|0.54||||0.004|2-Sided|95.0|0.36|0.83||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo||
1683172|NCT01211145|3095406|Superiority or Other||Odds Ratio (OR)|0.59||||0.087|2-Sided|95.0|0.33|1.08||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo||
1683173|NCT01211145|3095406|Superiority or Other||Odds Ratio (OR)|0.67||||0.153|2-Sided|95.0|0.38|1.16||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo||
1683174|NCT01211145|3095407|Superiority or Other||Odds Ratio (OR)|1.38||||0.127|2-Sided|95.0|0.91|2.08||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo||
1683175|NCT01211145|3095407|Superiority or Other||Odds Ratio, log|1.67||||0.067|2-Sided|95.0|0.96|2.91||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo||
1683176|NCT01211145|3095407|Superiority or Other||Odds Ratio (OR)|1.35||||0.274|2-Sided|95.0|0.79|2.32||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo||
1683177|NCT01211145|3095408|Superiority or Other||Odds Ratio (OR)|1.37||||0.127|2-Sided|95.0|0.91|2.04||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo||
1683178|NCT01211145|3095408|Superiority or Other||Odds Ratio (OR)|1.55||||0.145|2-Sided|95.0|0.86|2.79||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo||
1683179|NCT01211145|3095408|Superiority or Other||Odds Ratio (OR)|1.09||||0.753|2-Sided|95.0|0.64|1.84||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo||
1683180|NCT01211145|3095409|Superiority or Other||Odds Ratio (OR)|1.61||||0.01|2-Sided|95.0|1.12|2.32||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo||
1683181|NCT01211145|3095409|Superiority or Other||Odds Ratio (OR)|1.82||||0.021|2-Sided|95.0|1.09|3.03||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo||
1683182|NCT01211145|3095409|Superiority or Other||Odds Ratio (OR)|1.2||||0.458|2-Sided|95.0|0.74|1.96||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo||
1683183|NCT01211145|3095410|Superiority or Other||Odds Ratio (OR)|1.33||||0.137|2-Sided|95.0|0.91|1.95||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo||
1683184|NCT01211145|3095410|Superiority or Other||Odds Ratio (OR)|1.87||||0.032|2-Sided|95.0|1.06|3.31||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo||
1683185|NCT01211145|3095410|Superiority or Other||Odds Ratio (OR)|1.15||||0.575|2-Sided|95.0|0.7|1.91||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo||
1683186|NCT01211145|3095411|Superiority or Other||Odds Ratio (OR)|2.18|||<|0.001|2-Sided|95.0|1.4|3.39||Unadjusted|Regression, Logistic||ZOMIG 5.0 mg/Placebo||
1683187|NCT01211145|3095411|Superiority or Other||Odds Ratio (OR)|1.76|||<|0.071|2-Sided|95.0|0.95|3.26||Unadjusted|Regression, Logistic||ZOMIG 2.5 mg/Placebo||
1683188|NCT01211145|3095411|Superiority or Other||Odds Ratio (OR)|1.37|||<|0.312|2-Sided|95.0|0.75|2.5||Unadjusted|Regression, Logistic||ZOMIG 0.5 mg/Placebo||
1683189|NCT01210716|3095419|Non-Inferiority or Equivalence|If the lower 97.5% confidence limit on the mean of the paired differences is greater than -15% of the Control group mean (i.e., p-value <=0.05), then the Test group will be considered non-inferior in the primary efficacy parameter to Control at the margin of 15%.|Mean Difference (Final Values)|6.69|Standard Deviation|6.97|<|0.001|1-Sided|95.0|4.0||||paired t-test|||A one-sample t-test on the mean of paired differences was used to evaluate the primary objective. Sample size was determined using historical data and the 95% chi-square upper confidence limit on the observed standard deviation of the paired differences. A minimum sample of 27 pairs was required to demonstrate the AMICUS procedure to be non-inferior to Spectra with a mean efficiency of plasma removal with a non-inferiority margin of 15% with at least 97.5% (one-sided) confidence and 90% power.|
1683190|NCT01210651|3095437|Superiority or Other|||||||0.053||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value < 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on RSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on RSES for each intervention group would be statistically comparable.|
1683191|NCT01210651|3095438|Superiority or Other|||||||0.5||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value < 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on GSES, using an independent samples t-test to evaluate null hypothesis that Total Change Score on GSES for each intervention group would be statistically comparable.|
1683309|NCT01208233|3095762|Superiority or Other||Odds Ratio (OR)|0.972||||0.951|2-Sided|80.0|0.54|1.76|||Regression, Logistic|||LOCF was used to impute missing data.|
1683192|NCT01210651|3095439|Superiority or Other|||||||0.018||||||Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with a p-value < 0.05 required a priori to reject the null hypothesis.|Fisher Exact|||Fisher's Exact test evaluated null hypothesis that the proportion of study completers with remitted depression would be statistically comparable in the 2 intervention groups.|
1683193|NCT01210651|3095440|Superiority or Other|||||||0.02||||||Analysis performed via Stata v14.1, with P-value calculated using a t-distribution and assuming unequal variances in the two samples. Alpha was two-tailed. P-value < 0.05 was required a priori to reject the null hypothesis.|t-test, 2 sided|||Statistical analysis examined Total Change Scores on BDI, using two sample t-test to evaluate the null hypothesis that the Total Change Score on BDI for each intervention group would be statistically comparable.|
1683194|NCT01210651|3095441|Superiority or Other|||||||0.034||||||Analysis performed via Stata v14.1. Alpha was 2-tailed. P-value was calculated, with p-value < 0.05 required a priori to reject the null hypothesis.|Regression, Generalized Least Squares|||A random-effects, generalized least squares (GLS) regression model for depression severity was used to analyze participant BDI scores measured just before 1st assigned session at 0 wks, and just after assigned sessions at 2 wks, 4 wks, 6 wks and 8 wks. BDI Scores were modeled as correlated within participants but independent between participants. The GLS regression model tested the null hypothesis that no significant effects on BDI scores would be found by intervention and intervention-by-time.|
1683195|NCT01210495|3095464|Superiority or Other||Mean Difference (Final Values)|-7.03||||0.0193|2-Sided|95.0|-12.91|-1.15|||Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|
1683196|NCT01210495|3095465|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.0024|2-Sided|95.0|-0.2|-0.04|||Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|
1683197|NCT01210495|3095466|Superiority or Other||Hazard Ratio (HR)|1.252||||0.9182|2-Sided|95.0|0.923|1.698||The p-value is from a 1-sided log-rank test.|1-sided, unstratified log-rank test||Assuming proportional hazards, a hazard ratio <1 indicates reduction in hazard rate to favor Axitinib, hazard ratio >1 indicates reduction to favor Placebo.||
1683198|NCT01210495|3095467|Superiority or Other||Mean Difference (Final Values)|-10.45|||<|0.0001|2-Sided|95.0|-15.49|-5.42||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|
1683199|NCT01210495|3095468|Superiority||Mean Difference (Final Values)|-4.96||||0.0011|2-Sided|95.0|-7.93|-1.99||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|
1683200|NCT01210495|3095469|Superiority or Other||Mean Difference (Final Values)|-2.07||||0.0288|2-Sided|95.0|-3.92|-0.21||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G FWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|
1683201|NCT01210495|3095469|Superiority or Other||Mean Difference (Final Values)|-0.48||||0.4759|2-Sided|95.0|-1.8|0.84||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G EWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|
1683202|NCT01210495|3095469|Superiority or Other||Mean Difference (Final Values)|-1.27||||0.1642|2-Sided|95.0|-3.07|0.52||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G SWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|
1683203|NCT01210495|3095469|Superiority or Other||Mean Difference (Final Values)|-3.74|||<|0.0001|2-Sided|95.0|-5.26|-2.21||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis presented above is for FACT-G PWB. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|
1683204|NCT01210495|3095470|Superiority or Other||Mean Difference (Final Values)|-3.27|||<|0.0001|2-Sided|95.0|-4.76|-1.78||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|
1683205|NCT01210495|3095471|Superiority or Other||Mean Difference (Final Values)|-7.6||||0.0014|2-Sided|95.0|-12.27|-2.94||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|
1683206|NCT01210495|3095472|Superiority or Other||Mean Difference (Final Values)|-11.89||||0.0006|2-Sided|95.0|-18.7|-5.08||No adjustment made for multiple comparisons.|Longitudinal mixed effect analysis|||Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|
1683207|NCT01210495|3095481|Superiority or Other||Risk Ratio (RR)|2.65||||0.0025|2-Sided|95.0|1.319|5.326||For the overall stratified analysis the p-value is from Cochran-Mantel-Haenszel test of treatment stratified by geographical region and vascular invasion and extra hepatic spread.|Cochran-Mantel-Haenszel||Risk Ratio and CI based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.||
1683208|NCT01210495|3095483|Superiority or Other||Hazard Ratio (HR)|0.621||||0.006|2-Sided|95.0|0.434|0.889||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio <1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio >1 indicated a reduction in favor of Placebo.||
1683209|NCT01210495|3095484|Superiority or Other||Risk Ratio (RR)|3.172||||0.0914|2-Sided|95.0|0.759|13.265||ORR for the 2 treatment arms was compared with a significance level of 0.025 using Cochran-Mantel-Haenszel (CMH) test for stratified analyses.|Cochran-Mantel-Haenszel||Risk ratio and confidence interval (CI) were based on the Mantel-Haenszel estimator; risk ratio was adjusted for geographical region and vascular invasion and extra hepatic spread.||
1683210|NCT01210495|3095485|Superiority or Other||Hazard Ratio (HR)|0.618||||0.0039|2-Sided|95.0|0.438|0.871||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio <1 indicated a reduction in hazard rate in favor of Axitinib; a hazard ratio >1 indicated a reduction in favor of Placebo.||
1683211|NCT01210495|3095486|Superiority or Other||Hazard Ratio (HR)|0.907||||0.2872|2-Sided|95.0|0.646|1.274||For the overall stratified analysis the p-value is from a 1-sided log-rank test of treatment stratified by tumor invasion and geographic region.|Log Rank||Assuming proportional hazards, a hazard ratio less than (<) 1 indicated reduction in hazard rate to favor Axitinib; hazard ratio greater than (>) 1 indicated reduction to favor Placebo.|The study was designed to test the null hypothesis that the true median OS was 5 months vs. the alternative hypothesis that the true median OS was at least 8.3 months (i.e., 66 percent [%] improvement in median OS).|
1683212|NCT01210001|3095555|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.11|<|0.0001|2-Sided|97.5|-0.83|-0.36||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa vs placebo change from baseline in HbA1c for pio+met background only was the fourth step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 25mg minus placebo||
1683213|NCT01210001|3095555|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.11|<|0.0001|2-Sided|97.5|-0.69|-0.21||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa vs placebo change from baseline in HbA1c for pio+met background only was the fourth step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 10mg minus placebo||
1683214|NCT01210001|3095556|Superiority or Other||Mean Difference (Final Values)|-1.81|Standard Error of the Mean|0.3|<|0.0001|2-Sided|97.5|-2.49|-1.13||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in body weight was the third step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline weight|Difference calculated as empa 25mg minus placebo||
1683215|NCT01210001|3095556|Superiority or Other||Mean Difference (Final Values)|-1.95|Standard Error of the Mean|0.3|<|0.0001|2-Sided|97.5|-2.64|-1.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in body weight was the third step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline weight|Difference calculated as empa 10mg minus placebo||
1683216|NCT01210001|3095557|Superiority or Other||Mean Difference (Final Values)|-28.46|Standard Error of the Mean|3.68|<|0.0001|2-Sided|97.5|-36.73|-20.19||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in FPG was the second step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline FPG|Difference calculated as empa 25mg minus placebo||
1683217|NCT01210001|3095557|Superiority or Other||Mean Difference (Final Values)|-23.48|Standard Error of the Mean|3.71|<|0.0001|2-Sided|97.5|-31.81|-15.15||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in FPG was the second step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline, baseline HbA1c and baseline FPG|Difference calculated as empa 10mg minus placebo||
1683218|NCT01210001|3095558|Superiority or Other||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.09|<|0.0001|2-Sided|97.5|-0.82|-0.4||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in HbA1c was the first step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 25mg minus placebo||
1683219|NCT01210001|3095558|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.09|<|0.0001|2-Sided|97.5|-0.69|-0.27||Hierarchical testing to adjust for multiple comparisons within each dose level, alpha split equally between the doses (2.5%). Empa versus placebo change from baseline in HbA1c was the first step in each hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal function at baseline and baseline HbA1c.|Difference calculated as empa 10mg minus placebo||
1683220|NCT01209780|3095573|Non-Inferiority or Equivalence|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|0.95|||||2-Sided|95.0|0.85|1.07||||||Non-inferiority of investigational TIV to licensed control TIV against B influenza strain|
1683221|NCT01209780|3095573|Non-Inferiority or Equivalence|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|1.48|||||2-Sided|95.0|1.34|1.64||||||Non-inferiority of investigational TIV to licensed control TIV against A/H3N2 influenza strain|
1683222|NCT01209780|3095573|Non-Inferiority or Equivalence|The investigational TIV was to be considered non-inferior to the control TIV, if for all three strains, the upper bound of the two-sided 95% CI on the ratio of the GMTs (GMTcontrol/GMTinvestigational) at 21 days after last vaccination does not exceed 1.5|Ratio of GMTs|1.32|||||2-Sided|95.0|1.11|1.56||||||Non-inferiority of investigational TIV to licensed control TIV against A/H1N1 influenza strain|
1683223|NCT01209780|3095575|Non-Inferiority or Equivalence|The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points|Vaccine group difference (%)|-1.0|||||2-Sided|95.0|-5.0|3.0||||||Non-inferiority of investigational TIV to the control TIV against B influenza strain|
1683224|NCT01209780|3095575|Non-Inferiority or Equivalence|The investigational TIV was to be considered non-inferior to the control TIV if, for all three strains, the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control - Seroconversion investigational), at 21 days after last vaccination, does not exceed 10 percentage points|Vaccine group difference (%)|10.0|||||2-Sided|95.0|6.0|14.0||||||Non-inferiority of investigational TIV to control TIV against A/H3N2 influenza strain|
1683225|NCT01209780|3095575|Non-Inferiority or Equivalence|The investigational TIV was to be considered non-inferior to the control TIV if for all three strains the upper bound of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion control – Seroconversion investigational) at 21 days after last vaccination does not exceed 10 percentage points.|Vaccine group difference (%)|-1.0|||||2-Sided|95.0|-4.0|2.0||||||Non-inferiority of investigational TIV to control TIV against A/H1N1 influenza strain|
1683226|NCT01209325|3095642|Superiority|||||||0.423||||||Two-sided p-value.|Exact Poisson calculation||||
1683227|NCT01209325|3095643|Superiority|||||||0.422||||||Two-sided p-value.|Exact Poisson calculation||||
1683228|NCT01209325|3095644|Superiority|||||||0.809||||||Two-sided p-value.|0.809||||
1683229|NCT01209325|3095645|Superiority|||||||0.789||||||Two-sided p-value.|Exact Poisson calculation||||
1683230|NCT01209325|3095646|Superiority|||||||0.166||||||Two-sided p-value.|Exact Poisson calculation||||
1683231|NCT01209325|3095647|Superiority|||||||0.014|||||||Exact Poisson calculation||||
1683232|NCT01209325|3095648|Superiority|||||||0.745||||||Two-sided test.|Exact Poisson calculation||||
1683233|NCT01209325|3095649|Superiority|||||||0.064||||||Two-sided p-value.|Exact Poisson calculation||||
1683234|NCT01209325|3095650|Superiority|||||||0.15||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 18 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 18 (NCT00090285), 0.7 events per 100 person years (PY) versus 2.7 events per 100 PY, respectively. Merck 020 data were reported in Table 4 of Palefsky JM, Giuliano AR, Goldstone S et al. HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia. N Engl J Med 2011;365:1576-85.|
1683235|NCT01209325|3095650|Superiority|||||||0.622||||||Two-sided p-value.|Exact Poisson calculation||||
1683236|NCT01209325|3095651|Superiority|||||||0.305||||||One-sided test|Exact Poisson calculation|||This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 2.9 events per 100 person years (PY) versus 4.9 events per 100 PY, respectively. Merck 020 data were reported in Table 4 of Palefsky JM, Giuliano AR, Goldstone S et al. HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia. N Engl J Med 2011;365:1576-85.|
1683237|NCT01209325|3095651|Superiority|||||||0.386||||||Two-sided p-value.|Exact Poisson calculation||||
1683238|NCT01209325|3095652|Superiority|||||||0.209||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.7 events per 100 PY, respectively. Merck 020 data were reported in Table 4 of Palefsky JM, Giuliano AR, Goldstone S et al. HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia. N Engl J Med 2011;365:1576-85.|
1683239|NCT01209325|3095652|Superiority||||||>|0.999||||||Two-sided p-value.|Exact Poisson calculation||||
1683240|NCT01209325|3095653|Superiority|||||||0.312||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 1.8 events per 100 person years (PY) versus 4.5 events per 100 PY, respectively. Merck 020 data were reported in Table 4 of Palefsky JM, Giuliano AR, Goldstone S et al. HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia. N Engl J Med 2011;365:1576-85.|
1683241|NCT01209325|3095653|Superiority|||||||0.671||||||Two-sided p-value is comparing naive and prior exposure groups for HPV 6.|Exact Poisson calculation||||
1683242|NCT01209325|3095654|Superiority|||||||0.49||||||One-sided p-value|Exact Poisson calculation|||This study's Naive to HPV 18 group was compared to the Merck 020 per-protocol historical placebo group naive to HPV 18 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.0 events per 100 PY, respectively. Merck 020 data were reported in Table 2 of Palefsky JM, Giuliano AR, Goldstone S et al. HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia. N Engl J Med 2011;365:1576-85.|
1683243|NCT01209325|3095654|Superiority|||||||0.162|||||||Exact poisson test||||
1683244|NCT01209325|3095655|Superiority|||||||0.35||||||One-sided p-value.|Exact Poisson calculation|||This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.8 events per 100 PY, respectively. Merck 020 data were reported in Table 2 of Palefsky JM, Giuliano AR, Goldstone S et al. HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia. N Engl J Med 2011;365:1576-85.|
1683245|NCT01209325|3095655|Superiority|||||||0.079||||||Two-sided p-value.|Exact poisson test||||
1683246|NCT01209325|3095656|Superiority|One-sided p-value.||||||0.361|||||||Exact Poisson calculation|||This study's Naive to HPV 11 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 11 (NCT00090285), 0.0 events per 100 person years (PY) versus 2.0 events per 100 PY, respectively. Merck 020 data were reported in Table 2 of Palefsky JM, Giuliano AR, Goldstone S et al. HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia. N Engl J Med 2011;365:1576-85.|
1683247|NCT01209325|3095656|Superiority|||||||0.224||||||Two-sided p-value.|Exact poisson test||||
1683248|NCT01209325|3095657|Superiority|||||||0.447||||||One-sided test|Exact Poisson calculation|||This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 0.0 events per 100 person years (PY) versus 3.4 events per 100 PY, respectively. Merck 020 data were reported in Table 2 of Palefsky JM, Giuliano AR, Goldstone S et al. HPV Vaccine against Anal HPV Infection and Anal Intraepithelial Neoplasia. N Engl J Med 2011;365:1576-85.|
1683249|NCT01209325|3095657|Superiority|||||||0.112||||||Two-sided p-value|Exact poisson test||||
1683250|NCT01209260|3095671|Superiority or Other||||||<|0.001||||||Statistical tests were 2-sided and considered significant if they yielded a p<0.05.|Chi-squared||||
1683251|NCT01209260|3095672|Superiority or Other||||||<|0.001||||||Statistical tests were 2-sided and considered significant if they yielded a p<0.05|Chi-squared||||
1683252|NCT01209260|3095674|Superiority or Other|||||||0.005||||||Statistical tests were 2-sided and considered significant if they yielded a p<0.05|t-test, 2 sided|||Sample size of 72 was targeted to achieve 80% power to detect a 5-minute reduction in transseptal access procedure time (assuming a standard deviation of 7.5 minutes), using a 2-sided alpha of 0.05, with the primary analysis done on an intention-to-treat basis.|
1683253|NCT01209078|3095687|Superiority or Other||Difference|2.2||||||||||||||GSK1322322 1500 mg versus Linezolid 600 mg for No pathogens.|
1683254|NCT01209078|3095687|Superiority or Other||Difference|-37.5||||||||||||||GSK1322322 1500 mg versus Linezolid 600 mg for All pathogens.|
1683255|NCT01209078|3095687|Superiority or Other||Difference|-25.0||||||||||||||GSK1322322 1500 mg versus Linezolid 600 mg for Gram-negative pathogens.|
1683256|NCT01209078|3095687|Superiority or Other||Difference|-66.7||||||||||||||GSK1322322 1500 mg versus Linezolid 600 mg for Streptococcus pyogenes.|
1683257|NCT01209078|3095687|Superiority or Other||Difference|-28.6||||||||||||||GSK1322322 1500 mg versus Linezolid 600 mg for MSSA.|
1683258|NCT01209078|3095687|Superiority or Other||Difference|-37.5||||||||||||||GSK1322322 1500 mg versus Linezolid 600 mg for MRSA.|
1683259|NCT01209078|3095687|Superiority or Other||Difference|-35.4||||||||||||||GSK1322322 1500 mg versus Linezolid 600 mg for Staphylococcus aureus (all).|
1683260|NCT01209078|3095688|Superiority or Other||Mean Difference (Net)|37.4|||||2-Sided|95.0|-30.77|105.56|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up wound area.|
1683261|NCT01209078|3095688|Superiority or Other||Mean Difference (Net)|37.57|||||2-Sided|95.0|-28.25|103.4|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up wound area.|
1683262|NCT01209078|3095688|Superiority or Other||Mean Difference (Net)|34.21|||||2-Sided|95.0|-33.03|101.45|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 wound area.|
1683263|NCT01209078|3095688|Superiority or Other||Mean Difference (Net)|43.94|||||2-Sided|95.0|-22.43|110.31|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 wound area.|
1683264|NCT01209078|3095688|Superiority or Other||Median Difference (Net)|31.47|||||2-Sided|95.0|-33.53|96.47|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 wound area.|
1683265|NCT01209078|3095688|Superiority or Other||Mean Difference (Net)|-3.06|||||2-Sided|95.0|-66.54|60.43|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 wound area.|
1683266|NCT01209078|3095688|Superiority or Other||Mean Difference (Net)|-68.85|||||2-Sided|95.0|-132.8|-4.95|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 wound area.|
1683267|NCT01209078|3095689|Superiority or Other||Mean Difference (Net)|0.21|||||2-Sided|95.0|-2.09|2.52|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.|
1683268|NCT01209078|3095689|Superiority or Other||Mean Difference (Net)|0.74|||||2-Sided|95.0|-1.49|2.98|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.|
1683269|NCT01209078|3095689|Superiority or Other||Mean Difference (Net)|1.19|||||2-Sided|95.0|-1.09|3.47|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.|
1683270|NCT01209078|3095689|Superiority or Other||Mean Difference (Net)|1.79|||||2-Sided|95.0|-0.46|4.05|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.|
1683271|NCT01209078|3095689|Superiority or Other||Mean Difference (Net)|0.54|||||2-Sided|95.0|-1.68|2.75|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.|
1683272|NCT01209078|3095689|Superiority or Other||Mean Difference (Net)|-0.77|||||2-Sided|95.0|-2.94|1.41|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.|
1683273|NCT01209078|3095689|Superiority or Other||Mean Difference (Net)|-0.86|||||2-Sided|95.0|-3.04|1.33|||||The point estimate was calculated as least square mean difference (net values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.|
1683274|NCT01209078|3095690|Superiority or Other||Mean Difference (Final Values)|0.21|||||2-Sided|95.0|-2.09|2.52|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow-up total SIS.|
1683275|NCT01209078|3095690|Superiority or Other||Mean Difference (Final Values)|0.74|||||2-Sided|95.0|-1.49|2.98|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow-up total SIS.|
1683276|NCT01209078|3095690|Superiority or Other||Mean Difference (Final Values)|1.19|||||2-Sided|95.0|-1.09|3.47|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 total SIS.|
1683277|NCT01209078|3095690|Superiority or Other||Mean Difference (Final Values)|1.79|||||2-Sided|95.0|-0.46|4.05|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 total SIS.|
1683278|NCT01209078|3095690|Superiority or Other||Mean Difference (Final Values)|0.54|||||2-Sided|95.0|-1.68|2.75|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 total SIS.|
1683279|NCT01209078|3095690|Superiority or Other||Mean Difference (Final Values)|-0.77|||||2-Sided|95.0|-2.94|1.41|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 total SIS.|
1683280|NCT01209078|3095690|Superiority or Other||Mean Difference (Net)|-0.86|||||2-Sided|95.0|-3.04|1.33|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 total SIS.|
1683281|NCT01209078|3095691|Superiority or Other||Mean Difference (Final Values)|-0.03|||||2-Sided|95.0|-0.65|0.58|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 28 Day Follow- up exudate or pus score.|
1683282|NCT01209078|3095691|Superiority or Other||Mean Difference (Final Values)|0.06|||||2-Sided|95.0|-0.53|0.66|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for 7 Day Follow- up exudate or pus score.|
1683283|NCT01209078|3095691|Superiority or Other||Mean Difference (Final Values)|0.11|||||2-Sided|95.0|-0.49|0.72|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 11 exudate or pus score.|
1683284|NCT01209078|3095691|Superiority or Other||Mean Difference (Final Values)|0.35|||||2-Sided|95.0|-0.25|0.95|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 8 exudate or pus score.|
1683285|NCT01209078|3095691|Superiority or Other||Mean Difference (Final Values)|-0.16|||||2-Sided|95.0|-0.74|0.43|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 4 exudate or pus score.|
1683286|NCT01209078|3095691|Superiority or Other||Mean Difference (Final Values)|-0.12|||||2-Sided|95.0|-0.7|0.45|||||The point estimate was calculated as least square mean difference (final values) of GSK1322322 1500 mg and Linezolid 600 mg.|GSK1322322 1500 mg versus Linezolid 600 mg for Day 3 exudate or pus score.|
1683287|NCT01209078|3095691|Superiority or Other||Mean Difference (Final Values)|0.17|||||2-Sided|95.0|-0.41|0.74||||||GSK1322322 1500 mg versus Linezolid 600 mg for Day 2 exudate or pus score.|
1683288|NCT01209078|3095694|Superiority or Other||Difference|-35.0|||||2-Sided|95.0|-60.6|-9.4|||||||
1683289|NCT01209078|3095695|Superiority or Other||Difference|-35.0|||||2-Sided|95.0|-60.6|-9.4|||||||
1683290|NCT01209078|3095696|Superiority or Other||Difference|-24.0||||||||||||||GSK1322322 1500 mg versus Linezolid 600 mg for Follow-up Clinical Success.|
1683291|NCT01209078|3095696|Superiority or Other||Difference|-22.2||||||||||||||GSK1322322 1500 mg versus Linezolid 600 mg for end of therapy Clinical Success.|
1683292|NCT01208961|3095722|Superiority or Other||Ratio of Geometric Means|369.66|||<|0.001|2-Sided|90.0|301.74|452.86|||ANOVA|||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.|
1683293|NCT01208961|3095723|Superiority or Other||Ratio of Geometric Mans|649.66|||<|0.01|2-Sided|90.0|511.75|824.75||ANOVA model with baseline value as covariate, and treatment and user/non-user of lipid-altering drugs as factors. LSM estimate performed on log-scale|ANOVA|||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.|
1683294|NCT01208961|3095724|Superiority or Other||Ratio of Geometric Means|400.36|||<|0.001|2-Sided|90.0|326.87|490.36|||ANOVA|ANOVA on log-trans baseline-adj PK values using sequence, period, and treatments as fixed effects and subject nested within sequence as random effect||Results for the analyses of the High-Fat Periods were not posted because the critical comparison was the response of Lovaza versus Epanova to the clinically relevant low-fat diet to be used as adjunct in hypertriglyceridemia.|
1683295|NCT01208233|3095745|Superiority or Other||Mean Difference (Final Values)|-0.516|Standard Error of the Mean|2.7201||0.8501|2-Sided|80.0|-4.026|2.995|||Mixed Models Analysis|||Non-paretic hand|
1683296|NCT01208233|3095752|Superiority or Other||Mean Difference (Final Values)|0.089|Standard Error of the Mean|0.1226||0.4713|2-Sided|80.0|-0.07|0.248|||Mixed Models Analysis||||
1683297|NCT01208233|3095753|Superiority or Other||Mean Difference (Final Values)|-1.279|Standard Error of the Mean|0.5041||0.0128|2-Sided|80.0|-1.929|-0.629|||Mixed Models Analysis||||
1683298|NCT01208233|3095754|Superiority or Other||Mean Difference (Final Values)|0.106|Standard Error of the Mean|0.0733||0.1512|2-Sided|80.0|0.011|0.201|||Mixed Models Analysis|||(L R)/(L+R)|
1683299|NCT01208233|3095755|Superiority or Other||Mean Difference (Final Values)|1.049|Standard Error of the Mean|5.2816||0.843|2-Sided|80.0|-5.771|7.87|||Mixed Models Analysis|||(R/14) × 100%|
1683300|NCT01208233|3095755|Superiority or Other||Mean Difference (Final Values)|3.874|Standard Error of the Mean|6.7431||0.5671|2-Sided|80.0|-4.834|12.583|||Mixed Models Analysis|||(L/14) × 100%|
1683301|NCT01208233|3095755|Superiority or Other||Mean Difference (Final Values)|2.477|Standard Error of the Mean|5.4394||0.65|2-Sided|80.0|-4.547|9.5|||Mixed Models Analysis|||(L+R)/28 × 100%|
1683302|NCT01208233|3095756|Superiority or Other||Mean Difference (Final Values)|-0.334|Standard Error of the Mean|0.4178||0.426|2-Sided|80.0|-0.874|0.205|||Mixed Models Analysis||||
1683303|NCT01208233|3095757|Superiority or Other||Mean Difference (Final Values)|1.062|Standard Error of the Mean|1.7844||0.5541|2-Sided|80.0|-1.252|3.375|||Mixed Models Analysis||||
1683304|NCT01208233|3095758|Superiority or Other||Mean Difference (Final Values)|5.599|Standard Error of the Mean|4.4547||0.2118|2-Sided|80.0|-0.15|11.348|||Mixed Models Analysis||||
1683305|NCT01208233|3095759|Superiority or Other||Odds Ratio (OR)|1.651||||0.276|2-Sided|80.0|0.92|2.98|||Regression, Logistic|||BI=100, LOCF was used to impute missing data.|
1683306|NCT01208233|3095759|Superiority or Other||Odds Ratio (OR)|1.433||||0.4213|2-Sided|80.0|0.81|2.54|||Regression, Logistic|||BI >=95, LOCF was used to impute missing data.|
1683307|NCT01208233|3095760|Superiority or Other||Mean Difference (Final Values)|-0.283|Standard Error of the Mean|0.6755||0.6759|2-Sided|80.0|-1.156|0.589|||Mixed Models Analysis||||
1683370|NCT01205581|3096100|Superiority or Other|||||||0.51|||||||Fisher Exact||||
1683310|NCT01208233|3095763|Superiority or Other||Mean Difference (Final Values)|-12.812|Standard Error of the Mean|6.8448||0.0654|2-Sided|80.0|-21.668|-3.957|||Mixed Models Analysis|||Paretic to non-paretic hand ratio (%)|
1683311|NCT01208233|3095764|Superiority or Other||Mean Difference (Final Values)|0.235|Standard Error of the Mean|3.2899||0.9433|2-Sided|80.0|-4.011|4.48|||Mixed Models Analysis|||Non-paretic hand|
1683312|NCT01208233|3095764|Superiority or Other||Mean Difference (Final Values)|-10.33|Standard Error of the Mean|5.4241||0.0611|2-Sided|80.0|-17.351|-3.31|||Mixed Models Analysis|||Paretic hand|
1683313|NCT01208233|3095765|Superiority or Other||Mean Difference (Final Values)|10.789|Standard Error of the Mean|7.2392||0.1417|2-Sided|80.0|1.401|20.177|||Mixed Models Analysis|||Paretic to non-paretic hand ratio (%)|
1683314|NCT01208233|3095766|Superiority or Other||Mean Difference (Final Values)|0.141|Standard Error of the Mean|3.942||0.9716|2-Sided|80.0|-4.972|5.254|||Mixed Models Analysis|||Paretic hand|
1683315|NCT01208233|3095767|Superiority or Other||Odds Ratio (OR)|0.561||||0.2517|2-Sided|80.0|0.29|1.07|||Regression, Logistic|The analysis was based on OC.|||
1683316|NCT01208233|3095767|Superiority or Other||Odds Ratio (OR)|0.735||||0.4962|2-Sided|80.0|0.41|1.31|||Regression, Logistic|LOCF was used to impute missing data.|||
1683317|NCT01208207|3095777|Superiority or Other||Difference in Least Squares Mean|-2.7||||0.112||80.0|-4.88|-0.52|||ANCOVA||||
1683318|NCT01208207|3095778|Superiority or Other||Difference in Least Squares Mean|-1.58||||0.396|2-Sided|80.0|-3.96|0.81|||ANCOVA||||
1683319|NCT01208207|3095779|Non-Inferiority or Equivalence|The etoricoxib dose (60 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the LS mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).|Difference in Least Squares Mean|1.59|||||2-Sided|95.0|-2.19|5.37|||||||
1683320|NCT01208207|3095780|Non-Inferiority or Equivalence|The etoricoxib dose (90 mg) will be considered non-inferior to naproxen 1000 mg if the upper bound of the two-sided 95% confidence interval of the between-treatment difference in the least squares (LS) mean (etoricoxib minus naproxen 1000 mg) is no larger than 8 mm VAS (non-inferiority margin).|Difference in Least Squares Mean|-0.64|||||2-Sided|95.0|-5.47|4.19|||||||
1683321|NCT01208181|3095783|Superiority or Other||Difference in the least squares mean|1.61||||0.327|2-Sided|80.0|-0.49|3.71|||covariance model||||
1683322|NCT01208181|3095784|Superiority or Other||Difference in least squares mean|-2.71||||0.019|2-Sided|95.0|-4.98|-0.45|||Tukey-Ciminera-Heyse trend test||||
1683323|NCT01208181|3095785|Superiority or Other||Difference in least squares mean|0.02||||0.73|2-Sided|95.0|-0.1|0.14|||Tukey-Ciminera-Heysetrend test||||
1683324|NCT01208181|3095786|Superiority or Other||Difference in least squares mean|-10.7|||<|0.001|2-Sided|95.0|-14.74|-6.66|||Tukey-Ciminera-Heyse trend test||||
1683325|NCT01208181|3095786|Superiority or Other||Difference in least squares mean|-7.99|||<|0.001|2-Sided|95.0|-11.85|-4.13|||Tukey-Ciminera-Heyse trend test||||
1683326|NCT01208181|3095787|Superiority or Other||Difference in least squares mean|-0.27||||0.034|2-Sided|95.0|-0.48|-0.06|||Tukey-Ciminera-Heysetrend test||||
1683327|NCT01208181|3095787|Superiority or Other||Difference in least squares mean|-0.29||||0.004|2-Sided|95.0|-0.49|-0.09|||Tukey-Ciminera-Heysetrend test||||
1683328|NCT01207934|3095797|Superiority or Other||||||<|0.01||||||a priori threshold for significance was p = 0.05.|t-test, 2 sided|||null hypothesis was that plasma leptin levels would be equal after treatment in the placebo and high-dose leptin groups.|
1683329|NCT01207934|3095797|Superiority or Other||||||<|0.01||||||a priori threshold for significance was set at p = 0.05.|t-test, 2 sided|T-tests compared pre and post-treatment values.||The null hypothesis is that treatment would not effect plasma leptin levels.|
1683330|NCT01207934|3095798|Superiority or Other||||||>|0.05||||||ANOVA for reapeated measures was used to compare the three groups.|ANOVA|||The null hypothesis was that there would be no change in glucose disposal between the three groups (placebo, low dose leptin, and high dose leptin). Power calculations were done showing that 6 subjects in each arm was enough to detect a 35% between group difference in glucose disposal at the 0.05 level with 80% power.|
1683331|NCT01207453|3095865|Superiority or Other|||||||0.82||||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.|
1683332|NCT01207453|3095865|Superiority or Other|||||||0.72||||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.|
1683333|NCT01207453|3095866|Superiority or Other|||||||0.34||||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.|
1683334|NCT01207453|3095866|Superiority or Other|||||||0.35||||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.|
1683335|NCT01207453|3095867|Superiority or Other|||||||0.44||||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.|
1683336|NCT01207453|3095867|Superiority or Other|||||||0.89||||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.|
1683371|NCT01205581|3096101|Superiority or Other|||||||0.48|||||||Fisher Exact||||
1683372|NCT01205581|3096104|Superiority or Other|||||||0.78|||||||Fisher Exact||||
1683337|NCT01207453|3095868|Superiority or Other|||||||0.04||||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.|
1683338|NCT01207453|3095868|Superiority or Other|||||||0.04||||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.|
1683339|NCT01207453|3095869|Superiority or Other|||||||0.83||||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.|
1683340|NCT01207453|3095869|Superiority or Other|||||||0.89||||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed-rank tests.|
1683341|NCT01207453|3095870|Superiority or Other|||||||0.96||||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.|
1683342|NCT01207453|3095870|Superiority or Other|||||||0.39||||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using the Wilcoxon signed-rank tests.|
1683343|NCT01207453|3095871|Superiority or Other|||||||0.37||||||Linear mixed models including treatment, crossover period and treatment sequence. Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Mixed Models Analysis|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using linear mixed models.|
1683344|NCT01207453|3095871|Superiority or Other|||||||0.42||||||Not adjusted for multiple comparisons. A priori threshold for statistical significance was < 0.05.|Wilcoxon (Mann-Whitney)|||The difference between the change measured during placebo versus the change during milnacipran treatment. Calculated using Wilcoxon signed rank tests.|
1683345|NCT01207219|3095910|Superiority or Other||||||<|0.01||||||The p-value for statistical significance in these analyses was 0.01 adjusted for multiple comparisons .|Mixed Models Analysis|mixed-model analysis with a repeated-measures approach including an unstructured variance matrix||Data analysis was based on the Intention-to-Treatment (ITT) method. Differences between the three intervention groups over time (baseline and 12 weeks) were assessed with a Group x Time interaction term. A priori comparisons of the active intervention groups with the waitlist group were carried out with the same strategy if analyses including all the three groups meet the criterion of statistical significance (P<0.01).|
1683346|NCT01206764|3095922|Other|Kaplan Meier|Median Difference (Net)|45.71|||||2-Sided|95.0|31.29|106.43||||||The median overall survival was not evaluable, this presents the 25th percentile of overall survival|
1683347|NCT01206764|3095926|Other|Kaplan Meier|Median Difference (Net)|27.71|||||2-Sided|95.0|21.86|35.29||||||Single arm open label study|
1683348|NCT01206660|3095929|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1683349|NCT01206660|3095930|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1683350|NCT01206660|3095931|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1683351|NCT01206582|3095936|Superiority or Other|||||||0.01|||||||ANCOVA|||Comparison for Platelets on Day 4|
1683352|NCT01206582|3095937|Superiority or Other||||||<|0.05|||||||ANCOVA|||Comparison for Day 7|
1683353|NCT01206582|3095938|Superiority or Other||||||<|0.05|||||||ANCOVA|||Comparison for Day 7|
1683354|NCT01206582|3095945|Superiority or Other|||||||0.0003|||||||ANCOVA|||Comparison for day 3|
1683355|NCT01206582|3095946|Superiority or Other|||||||0.008|||||||ANCOVA|||Comparison for day 7|
1683356|NCT01206582|3095946|Superiority or Other|||||||0.0002|||||||ANCOVA|||Comparison for day 3|
1683357|NCT01206387|3095967|Superiority or Other|||||||0.0011|||||||t-test, 2 sided||||
1683358|NCT01206387|3095968|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1683359|NCT01206387|3095969|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1683360|NCT01206387|3095970|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1683361|NCT01206387|3095971|Superiority or Other|||||||0.0003|||||||t-test, 2 sided||||
1683362|NCT01206062|3095987|Superiority or Other||Hazard Ratio (HR)|0.79||||0.58|2-Sided|95.0|0.34|1.83|||Regression, Cox||||
1683363|NCT01206062|3095988|Superiority or Other||Hazard Ratio (HR)|0.73||||0.003|2-Sided|95.0|0.6|0.9|||Regression, Cox||||
1683364|NCT01206062|3095989|Superiority or Other||Hazard Ratio (HR)|0.75|||<|0.001|2-Sided|95.0|0.64|0.89|||Regression, Cox||||
1683365|NCT01205776|3096072|Non-Inferiority|p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.|Hazard Ratio (HR)|4.0||||0.011|2-Sided|||||p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 8.4% at the 0.05 level of significance.|Com-Nougue Approach||||
1683366|NCT01205776|3096084|Non-Inferiority|p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.|Hazard Ratio (HR)|-3.1|||<|0.0001|2-Sided|||||p-value and 95% CI of the Difference derived from the Com-Nougue Approach of non-inferiority for two Kaplan-Meier Failure rates with a non-inferiority margin of 2% at the 0.05 level of significance.|Com-Nougue||||
1683367|NCT01205581|3096097|Superiority or Other|||||||0.11|||||||Fisher Exact||||
1683368|NCT01205581|3096098|Superiority or Other|||||||0.43|||||||Fisher Exact||||
1683369|NCT01205581|3096099|Superiority or Other|||||||0.29|||||||Fisher Exact||||
1683373|NCT01205529|3096111|Superiority||Odds Ratio (OR)|0.0||||1|2-Sided||||||Regression, Logistic||0 participants with rare SCN5A non-synonymous variants met the primary outcome for ST-segment elevation.||Given the very small number of outcomes (N=4) and the small number of participants with the primary determinant (N=2), a Fisher's Exact Test is the appropriate test and it yields a P-value=1.000.
1683374|NCT01205503|3096116|Superiority or Other|||||||0.014||||||This is for the interaction between baseline tnf-alpha levels and treatment received (mesna vs saline).|Mixed Models Analysis|Model was adjusted for baseline biochemical measures, time of measurement, treatment (mesna or saline), chemo type, and first-order interactions.|||
1683375|NCT01205451|3096135|Superiority or Other||t-distribution|-1.12|||<|0.0001|2-Sided|95.0|-1.33|-0.91||The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.||
1683376|NCT01205451|3096135|Superiority or Other||t-distribution|-0.88|||<|0.0001|2-Sided|95.0|-1.04|-0.72||The P-value for change from Baseline indicates the comparision of the Week 12 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.||
1683377|NCT01205451|3096135|Superiority or Other||t-distribution|-1.33|||<|0.0001|2-Sided|95.0|-1.54|-1.12||The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.||
1683378|NCT01205451|3096135|Superiority or Other||t-distribution|-1.21|||<|0.0001|2-Sided|95.0|-1.38|-1.04||The P-value for change from Baseline indicates the comparision of the Week 6 value against the Baseline value.|Wilcoxon signed-rank test||Confidence intervals for means were based on the t-distribution.||
1683379|NCT01205230|3096171|Superiority or Other||Mean Difference (Final Values)|1.07|||||2-Sided|90.0|-0.1|2.44|||||||
1683380|NCT01205230|3096171|Superiority or Other||Median Difference (Final Values)|-0.45|||||2-Sided|90.0|-1.06|0.06|||||||
1683381|NCT01205230|3096172|Superiority or Other||Ratio of LS geometric means|0.58|||||2-Sided|90.0|0.5|0.67|||||Ratio of LS geometric means (Pazopanib + Esomeprazole : Pazopanib alone)||
1683382|NCT01205230|3096172|Superiority or Other||Ratio of LS geometric means|1.45|||||2-Sided|90.0|1.14|1.86|||||Ratio of LS geometric means (Pazopanib + Ketoconozole : Pazopanib alone)||
1683383|NCT01205230|3096173|Superiority or Other||Ratio of LS geometric means|0.6|||||2-Sided|90.0|0.52|0.7|||||Ratio of LS geometric means (Pazopanib + Esomeprazole : Pazopanib alone)||
1683384|NCT01205230|3096173|Superiority or Other||Ratio of least square geometric means|1.66|||||2-Sided|90.0|1.39|1.99|||||Ratio of least square (LS) geometric means (Pazopanib + Ketoconozole : Pazopanib alone)||
1683385|NCT01205165|3096183|Superiority or Other|||||||0||||||P-value is calculated from Wilcoxon signed rank test to compare difference between baseline and week12|Wilcoxon signed rank test|||Baseline and Week 12|
1683386|NCT01205152|3096189|Other|||||||0.002||||||Two-sided with p-value threshold <0.05 for statistical significance.|Wilcoxon signed-rank test|||Change is relative to Baseline in Study ENB-002-08 (NCT00744042). The RGI-C score represents evaluation of skeletal X-rays at each post-treatment study timepoint compared with pre-treatment X-rays from Study ENB-002-08 using an ordinal scale. Therefore, an RGI-C score is not applicable for radiographs obtained at Baseline.|
1683387|NCT01205126|3096191|Superiority or Other|||||||0.276|||||||rank sum test, 2 sided||||
1683388|NCT01205126|3096192|Non-Inferiority or Equivalence|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.||||||0.304|||||||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29|||
1683389|NCT01205126|3096193|Non-Inferiority or Equivalence|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.||||||0.832|||||||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.|||
1683390|NCT01205126|3096194|Non-Inferiority or Equivalence|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.2|Standard Error of the Mean|0.44||0.621|2-Sided|95.0|-1.1|0.7|||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.|||
1683391|NCT01205126|3096195|Non-Inferiority or Equivalence|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.2|Standard Error of the Mean|0.39||0.615|2-Sided|95.0|-1.0|0.6|||ANCOVA|P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.|||
1683392|NCT01205126|3096196|Non-Inferiority or Equivalence|Non inferiority was demonstrated if upper bound of the 2-sided 95% CI was less than the non-inferiority margin of 1.5.|Least square mean difference|-0.1|Standard Error of the Mean|0.6||0.855|2-Sided|95.0|-1.3|1.1||P-value was calculated by ANCOVA model using Baseline as covariate for change at Day 29.|ANCOVA||||
1683393|NCT01204905|3096206|Other|There were no power calculations performed due to the size of the pilot study.|||||||||||||||||Number of weeks to virologic suppression
1683394|NCT01204905|3096207|Other|This was a pilot study with a small sample population. There were no power calculations performed.|||||||||||||||||The percentage of patients with HIV-1 viral loads less than 50 c/ml at 48 weeks.
1683395|NCT01204710|3096225|Superiority or Other (legacy)|||||||0.4986|||||||Fisher Exact||||
1683396|NCT01204710|3096226|Superiority or Other (legacy)|||||||0.6571|||||||Fisher Exact||||
1683397|NCT01204710|3096227|Superiority or Other (legacy)|||||||0.3465|||||||Fisher Exact||||
1683398|NCT01204710|3096228|Superiority or Other (legacy)||Hazard Ratio (HR)|1.08||||0.7291|2-Sided|95.0|0.72|1.61||Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.|Log Rank||Hazard ratio is expressed as Olaratumab + Mitoxantrone / Mitoxantrone and estimated from Cox model.||
1683399|NCT01204710|3096229|Superiority or Other (legacy)||Hazard Ratio (HR)|1.29||||0.2201|2-Sided|95.0|0.87|1.9||Analysis was stratified by the randomization stratification factor: best overall response to prior docetaxel-based chemotherapy.|Log Rank||Hazard ratio is expressed as IMC-3G3 + Mitoxantrone / Mitoxantrone and estimated from Cox model.||
1683410|NCT01203852|3096315|Superiority or Other||||||<|0.0001||||||P-value for one sided t-test of mean change in blood pressure before and after treatment with metoprolol and chlorthalidone were <0.0001.|t-test, 1 sided||||
1683400|NCT01204658|3096275|Non-Inferiority or Equivalence|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.|Difference in percentage|0.0||||0.003|2-Sided|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips’ approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-HD Group minus Synflorix Group.|
1683401|NCT01204658|3096275|Non-Inferiority or Equivalence|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.|Difference in percentage|0.0||||0.003|2-Sided|95.0|-2.63|2.66||1-sided P-value computed using Kem Philips’ approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-HD Group minus Synflorix Group.|
1683402|NCT01204658|3096275|Non-Inferiority or Equivalence|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.|Difference in percentage|0.0||||0.003|2-Sided|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips’ approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-HD Group minus Synflorix Group.|
1683403|NCT01204658|3096275|Non-Inferiority or Equivalence|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.|Difference in percentage|0.0||||0.003|2-Sided|95.0|-2.61|2.64||1-sided P-value computed using Kem Philips’ approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-HD Group minus Synflorix Group.|
1683404|NCT01204658|3096276|Non-Inferiority or Equivalence|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.|Difference in percentage|0.0||||0.003|2-Sided|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips’ approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-LD Group minus Synflorix Group.|
1683405|NCT01204658|3096276|Non-Inferiority or Equivalence|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.|Difference in percentage|0.0||||0.003|2-Sided|95.0|-2.62|2.57||1-sided P-value computed using Kem Philips’ approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-LD Group minus Synflorix Group.|
1683406|NCT01204658|3096276|Non-Inferiority or Equivalence|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.|Difference in percentage|0.0||||0.003|2-Sided|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-LD Group minus Synflorix Group.|
1683407|NCT01204658|3096276|Non-Inferiority or Equivalence|Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.|Difference in percentage|0.0||||0.003|2-Sided|95.0|-2.61|2.57||1-sided P-value computed using Kem Philips’ approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.|Kem Phillip's statistical test|||Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-LD Group minus Synflorix Group.|
1683408|NCT01203852|3096314|Superiority or Other|||||||0.049||||||P-value for one sided t-test for mean glucose change before and after treatment with metoprolol was 0.049.|t-test, 1 sided|||Mean glucose change after treatment with metoprolol|
1683409|NCT01203852|3096314|Superiority or Other||||||<|0.0001||||||P-value for one sided t-test for mean glucose change before and after treatment with chlorthalidone was <0.0001.|t-test, 1 sided|||Mean glucose change after treatment with chlorthalidone|
1683444|NCT01200758|3096644|Superiority or Other||Geometric mean ratio|0.941|||||2-Sided|95.0|0.872|1.015|||||||
1683411|NCT01203826|3096316|Other|||||||0.0005|||||||Wilcoxon signed-rank test|P-value based on Wilcoxon signed-rank test.||Change is relative to Baseline in Study ENB-006-09 (NCT00952484). The RGI-C score represents evaluations of skeletal X-rays at each post-treatment study timepoint in Study ENB-008-10 compared with pre-treatment X-rays from Study ENB-006-09, using an ordinal scale. Therefore, no Baseline data for RGI-C are available.|
1683412|NCT01203787|3096323|Superiority or Other|||||||0.0262|||||||Wilcoxon rank sum test||||
1683413|NCT01203098|3096336|Superiority or Other||Cox Proportional Hazard|1.1|||||2-Sided|95.0|-4.6|6.8||||||Primary analyses were performed on proportion of subjects who experienced thromboembolic events defined as primary efficacy endpoint (incidence of thromboembolic events); incidence of thromboembolic events and its 95% confidence interval (CI) were calculated by treatment group, and difference between DU-176b 15 mg and 30 mg groups and its 95% CI were also calculated. For reference, difference between enoxaparin group and each DU-176b group and its 95% CI of each were calculated.|
1683414|NCT01203098|3096336|Superiority or Other||Cox Proportional Hazard|-1.3|||||2-Sided|95.0|-7.2|4.6||||||Primary analyses were performed on proportion of subjects who experienced thromboembolic events defined as primary efficacy endpoint (incidence of thromboembolic events); incidence of thromboembolic events and its 95% confidence interval (CI) were calculated by treatment group, and difference between DU-176b 15 mg and 30 mg groups and its 95% CI were also calculated. For reference, difference between enoxaparin group and each DU-176b group and its 95% CI of each were calculated.|
1683415|NCT01203072|3096338|Superiority or Other||||||<|0.001||||||Significance level for Cochran-Armitage test and comparison using Shirley-Williams method was set at one-sided, 0.025. For other tests, significance level and confidence coefficient were set at two-sided, 0.05 and 0.95, respectively, unless specified|Cochran-Armitage|||As the primary analysis, the dose-response relationship in the incidence of thromboembolic event was verified using the Cochran-Armitage test.|
1683416|NCT01203046|3096339|Non-Inferiority or Equivalence|Consider a 5% confidence level, the power of assigned contrast was 80% to detect a difference minima of at least 10% of equivalence between the analyzed groups.|Odds Ratio (OR)|1.18|||<|0.05|2-Sided|95.0|0.21|6.51|||Regression, Logistic||||
1683417|NCT01203046|3096340|Non-Inferiority or Equivalence|It was used for the calculation of statistical power an author of 5% level, it was felt that the difference between the minimum value of non inferiority does not exceed 10%.|Odds Ratio (OR)|2.65|||<|0.05|2-Sided|95.0|0.35|19.83|||Regression, Logistic||||
1683418|NCT01202994|3096342|Other||correlation coefficient|-0.45|||<|0.05|2-Sided|||||This is a calculated p-value.|correlation|||The primary analysis is to examine the correlation between the practice effect z-score (presented in the Secondary Outcome section) and the standardized uptake value of flutemetamol (presented in the Outcome module).|
1683419|NCT01202747|3096398|Superiority or Other|||||||0.0005||||||p<0.05 considered statistically significant|Regression, Linear||||
1683420|NCT01202656|3096402|Superiority or Other|||||||0.72|||||||Cochran-Mantel-Haenszel||||
1683421|NCT01202643|3096403|Superiority or Other|||||||0.74|||||||Chi-squared, Corrected|||Study was closed due to insufficient recruitment|
1683422|NCT01202643|3096404|Superiority or Other|||||||0.67|||||||ANCOVA||||
1683423|NCT01202279|3096432|Superiority or Other|||||||0.022|||||||ANCOVA||||
1683424|NCT01202279|3096433|Superiority or Other|||||||0.025|||||||Fisher Exact||||
1683425|NCT01201967|3096533|Superiority or Other||Mean Difference (Final Values)|2.3||||0.11|2-Sided|95.0|-0.54|5.14|||Mixed Models Analysis||||
1683426|NCT01201967|3096534|Superiority or Other||Mean Difference (Final Values)|5.59||||0.005|2-Sided|95.0|1.71|9.46|||Mixed Models Analysis||||
1683427|NCT01201967|3096535|Superiority or Other||Mean Difference (Final Values)|0.11||||0.029|2-Sided|95.0|0.012|0.22|||Mixed Models Analysis||||
1683428|NCT01201967|3096536|Superiority or Other||Risk Ratio (RR)|0.96||||0.83|2-Sided|95.0|0.63|1.46|||Chi-squared||||
1683429|NCT01201967|3096537|Superiority or Other||Mean Difference (Final Values)|0.63||||0.28|2-Sided|95.0|-0.51|1.76|||Mixed Models Analysis||||
1683430|NCT01201967|3096538|Superiority or Other||Risk Ratio (RR)|11.4|||<|0.001|2-Sided|95.0|5.2|24.9|||Chi-squared||||
1683431|NCT01201967|3096539|Superiority or Other||Mean Difference (Final Values)|-0.41||||0.55|2-Sided|95.0|-0.93|1.76|||Mixed Models Analysis||||
1683432|NCT01201967|3096540|Superiority or Other||Mean Difference (Final Values)|-2.05||||0.045|2-Sided|95.0|-4.06|-0.05|||Mixed Models Analysis||||
1683433|NCT01201967|3096541|Superiority or Other||Mean Difference (Final Values)|5.68||||0.002|2-Sided|95.0|2.14|9.22|||Mixed Models Analysis||||
1683434|NCT01201915|3096543|Superiority or Other|||||||0.7878|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.|
1683435|NCT01201915|3096543|Superiority or Other|||||||0.9668|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 30% or less.|
1683436|NCT01201915|3096543|Superiority or Other|||||||0.8463|||||||1-sided exact binomial test|||The null hypothesis was that percentage of participants with complete histologic clearance was 50% or less.|
1683437|NCT01201798|3096570|Non-Inferiority or Equivalence|The noninferiority margin was 0.5 units, meaning that the upper limit of the two-tailed 95% confidence interval must have been less than 0.5 to establish noninferiority.|Mean Difference (Net)|-0.22|||||2-Sided|95.0|-0.53|0.09||||||A two-tailed 95% confidence interval was calculated for the difference in change from baseline in anterior chamber cell grade at Day 14 (difluprednate minus prednisolone). The confidence interval was derived from an analysis of covariance (ANCOVA), with investigative site included as a fixed effect to match the stratification used in the randomization process. Treatment and baseline anterior chamber cell grade were also included as fixed effects.|
1683438|NCT01201629|3096578|Other||||||<|0.05|||||||t-test, 2 sided||||
1683439|NCT01201629|3096579|Other||||||<|0.05|||||||t-test, 2 sided||||
1683440|NCT01201486|3096580|Superiority or Other||Percentage Sensitivity|23.0|||||2-Sided||||||||||
1683441|NCT01201057|3096616|Superiority|||||||0.025|||||||Cochran-Mantel-Haenszel||||
1683442|NCT01201057|3096617|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1683443|NCT01201057|3096618|Superiority|||||||0.006|||||||Cochran-Mantel-Haenszel||||
1683445|NCT01200758|3096645|Superiority or Other||Geometric mean ratio|1.38|||||2-Sided|90.0|1.24|1.53||||||The ratio of observed rituximab serum was determined as AUC SC/AUC IV during Cycle 7 of induction treatment.|
1683446|NCT01200758|3096648|Superiority or Other||Hazard Ratio (HR)|0.98||||0.9115|2-Sided|95.0|0.71|1.36|||Wald test||||
1683447|NCT01200758|3096650|Superiority or Other||Hazard Ratio (HR)|0.9||||0.5526|2-Sided|95.0|0.64|1.26|||Wald test||||
1683448|NCT01200758|3096652|Superiority or Other||Odds Ratio (OR)|0.99|||||2-Sided|95.0|0.6|1.64|||||||
1683449|NCT01200758|3096652|Superiority or Other||Difference in response rates|-0.18||||0.9671|2-Sided|95.0|-9.2|8.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.||
1683450|NCT01200758|3096653|Superiority or Other||Odds Ratio (OR)|0.8|||||2-Sided|95.0|0.52|1.22|||||||
1683451|NCT01200758|3096653|Superiority or Other||Difference in response rates|-7.28||||0.1715|2-Sided|95.0|-18.0|3.5|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.||
1683452|NCT01200758|3096654|Superiority or Other||Odds Ratio (OR)|1.0|||||2-Sided|95.0|0.66|1.51|||||||
1683453|NCT01200758|3096654|Superiority or Other||Difference in response rates|0.49||||0.9157|2-Sided|95.0|-8.8|9.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.||
1683454|NCT01200758|3096655|Superiority or Other||Odds Ratio (OR)|0.74|||||2-Sided|95.0|0.44|1.22|||||||
1683455|NCT01200758|3096655|Superiority or Other||Difference in response rates|-6.58||||0.2331|2-Sided|95.0|-17.8|4.6|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.||
1683456|NCT01200758|3096656|Superiority or Other||Odds Ratio (OR)|2.25|||||2-Sided|95.0|1.06|4.78|||||||
1683457|NCT01200758|3096656|Superiority or Other||Difference in CRR|17.86||||0.0335|2-Sided|95.0|0.8|35.0|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.||
1683458|NCT01200758|3096657|Superiority or Other||Odds Ratio (OR)|0.96|||||2-Sided|95.0|0.56|1.65|||||||
1683459|NCT01200758|3096657|Superiority or Other||Difference in response rates|-0.49||||0.8911|2-Sided|95.0|-7.7|6.8|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson.||
1683460|NCT01200758|3096658|Superiority or Other||Odds Ratio (OR)|1.97|||||2-Sided|95.0|0.68|5.71|||||||
1683461|NCT01200758|3096658|Superiority or Other||Difference in response rates|7.66||||0.2047|2-Sided|95.0|-5.0|20.3|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.||
1683462|NCT01200758|3096659|Superiority or Other||Odds Ratio (OR)|0.71|||||2-Sided|95.0|0.38|1.33|||||||
1683463|NCT01200758|3096659|Superiority or Other||Difference in response rates|-4.82||||0.2835|2-Sided|95.0|-14.0|4.4|||Chi-squared||The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.||
1683464|NCT01200758|3096660|Non-Inferiority or Equivalence|Non-inferior Ctrough in SC formulation was demonstrated, if the lower bound of 90% confidence interval (CI) was above 0.8.|Geometric mean ratio|1.62|||||2-Sided|90.0|1.36|1.94|||||Geometric mean ratio adjusted for tumor load at baseline.||
1683465|NCT01200589|3096675|Superiority or Other||Hazard Ratio (HR)|1.15|||||2-Sided|95.0|0.89|1.49|||||||
1683466|NCT01200433|3096688|Superiority or Other||Median Difference (Final Values)|0.0|||>|0.99|2-Sided|99.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||||
1683467|NCT01200433|3096689|Superiority or Other||Median Difference (Final Values)|-1.9||||0.02|2-Sided|99.0|-4.1|0.2|||Wilcoxon (Mann-Whitney)||||
1683468|NCT01200433|3096691|Superiority or Other||Ratio of Geometric Means|1.0||||0.91|2-Sided|99.0|0.86|1.18|||Wilcoxon (Mann-Whitney)||||
1683469|NCT01200433|3096692|Superiority or Other||Median Difference (Final Values)|1.0|||<|0.001|2-Sided|99.0|0.0|2.0|||Wilcoxon (Mann-Whitney)||||
1683470|NCT01200433|3096694|Non-Inferiority or Equivalence|"We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.~A total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution."|Ratio of Geometric Means|0.99|||<|0.001|2-Sided|90.0|0.96|1.02|||t-test, 1 sided||Dexmedetomidine vs. propofol||
1683471|NCT01200433|3096695|Non-Inferiority or Equivalence|"We tested a joint hypothesis that dexmedetomidine was noninferior to propofol both in terms of cerebral blood flow velocity and brain oxygenation during DBS surgery.~A total of 44 patients provided a 90% power at the 0.05 significance level to detect noninferiority of dexmedetomidine to propofol using a noninferiority ratio of geometric means of 0.80, assuming a coefficient of variation of 25% for each of the 2 primary outcomes. Both outcomes were expected to follow a log-normal distribution."|Ratio of Geometric Means|0.94||||0.011|2-Sided|90.0|0.84|1.05|||t-test, 1 sided||Dexmedetomidine vs. propofol||
1683472|NCT01200394|3096705|Superiority||Geometric Mean Ratio|1.1154||||0.3733|2-Sided|95.0|0.8761|1.4201|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683473|NCT01200394|3096705|Superiority||Geometric Mean Ratio|1.0435||||0.7264|2-Sided|95.0|0.8211|1.3262|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683474|NCT01200394|3096705|Superiority||Geometric Mean Ratio|0.7998||||0.049|2-Sided|95.0|0.6402|0.999|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683475|NCT01200394|3096705|Superiority||Geometric Mean Ratio|0.9282||||0.5422|2-Sided|95.0|0.7297|1.1807|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683476|NCT01200394|3096707|Superiority||LS Mean Difference|0.46|Standard Error of the Mean|1.1355||0.6838|2-Sided|95.0|-1.77|2.7|||Mixed Models Analysis|||Supine Mean BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683477|NCT01200394|3096707|Superiority||LS Mean Difference|0.65|Standard Error of the Mean|0.9917||0.5123|2-Sided|95.0|-1.3|2.61|||Mixed Models Analysis|||Supine Diastolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683478|NCT01200394|3096707|Superiority||LS Mean Difference|0.51|Standard Error of the Mean|1.7065||0.7644|2-Sided|95.0|-2.85|3.87|||Mixed Models Analysis|||Supine Systolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683479|NCT01200394|3096707|Superiority||LS Mean Difference|-0.27|Standard Error of the Mean|1.2722||0.8297|2-Sided|95.0|-2.78|2.23|||Mixed Models Analysis|||Supine Mean BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683480|NCT01200394|3096707|Superiority||LS Mean Difference|-0.63|Standard Error of the Mean|1.073||0.5607|2-Sided|95.0|-2.74|1.49|||Mixed Models Analysis|||Supine Diastolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683481|NCT01200394|3096707|Superiority||LS Mean Difference|0.8|Standard Error of the Mean|1.8764||0.6695|2-Sided|95.0|-2.9|4.5|||Mixed Models Analysis|||Supine Systolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683482|NCT01200394|3096707|Superiority||LS Mean Difference|-0.67|Standard Error of the Mean|1.0582||0.5281|2-Sided|95.0|-2.75|1.42|||Mixed Models Analysis|||Supine Mean BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683483|NCT01200394|3096707|Superiority||LS Mean Difference|-0.47|Standard Error of the Mean|0.9235||0.6141|2-Sided|95.0|-2.29|1.35|||Mixed Models Analysis|||Supine Diastolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683484|NCT01200394|3096707|Superiority||LS Mean Difference|-0.48|Standard Error of the Mean|1.4926||0.7491|2-Sided|95.0|-3.42|2.46|||Mixed Models Analysis|||Supine Systolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683485|NCT01200394|3096707|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|1.0334||0.8763|2-Sided|95.0|-2.2|1.87|||Mixed Models Analysis|||Supine Mean BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683486|NCT01200394|3096707|Superiority||LS Mean Difference|0.4|Standard Error of the Mean|0.9089||0.6564|2-Sided|95.0|-1.39|2.2|||Mixed Models Analysis|||Supine Diastolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683487|NCT01200394|3096707|Superiority||LS Mean Difference|-0.52|Standard Error of the Mean|1.4056||0.7093|2-Sided|95.0|-3.29|2.24|||Mixed Models Analysis|||Supine Systolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683488|NCT01200394|3096707|Superiority||LS Mean Difference|-4.59|Standard Error of the Mean|0.9489|<|0.0001|2-Sided|95.0|-6.46|-2.72|||Mixed Models Analysis|||Supine Mean BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683489|NCT01200394|3096707|Superiority||LS Mean Difference|-3.71|Standard Error of the Mean|0.849|<|0.0001|2-Sided|95.0|-5.38|-2.04|||Mixed Models Analysis|||Supine Diastolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683490|NCT01200394|3096707|Superiority||Least Squares (LS) Mean Difference|-5.39|Standard Error of the Mean|1.2942|<|0.0001|2-Sided|95.0|-7.94|-2.84|||Mixed Models Analysis|||Supine Systolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.|
1683508|NCT01200368|3096722|Superiority or Other||GMC ratio|0.92|||||2-Sided|95.0|0.81|1.05||||||GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.|
1683671|NCT01197560|3097074|Superiority|||||||0.16|||||||Fisher Exact|||Pertains to all participants; row 1|
1683491|NCT01200394|3096708|Superiority||Geometric Mean Ratio|1.0024||||0.9146|2-Sided|95.0|0.9588|1.0481|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683492|NCT01200394|3096708|Superiority||Geometric Mean Ratio|0.9866||||0.4972|2-Sided|95.0|0.9488|1.0259|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683493|NCT01200394|3096708|Superiority||Geometric Mean Ratio|0.9939||||0.7475|2-Sided|95.0|0.9577|1.0315|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683494|NCT01200394|3096708|Superiority||Geometric Mean Ratio|0.9816||||0.3585|2-Sided|95.0|0.9434|1.0214|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683495|NCT01200394|3096709|Superiority||Geometric Mean Ratio|0.8634||||0.1151|2-Sided|95.0|0.719|1.0368|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683496|NCT01200394|3096709|Superiority||Geometric Mean Ratio|0.7937||||0.0068|2-Sided|95.0|0.6717|0.9378|||Mixed Models Analysis|||Week 12: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683497|NCT01200394|3096709|Superiority||Geometric Mean Ratio|0.8524||||0.0305|2-Sided|95.0|0.7376|0.985|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683498|NCT01200394|3096709|Superiority||Geometric Mean Ratio|0.8565||||0.0297|2-Sided|95.0|0.745|0.9847|||Mixed Models Analysis|||Week 3: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683499|NCT01200394|3096710|Superiority||Geometric Mean Ratio|0.8816||||0.149|2-Sided|95.0|0.7427|1.0465|||Mixed Models Analysis|||Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683500|NCT01200394|3096710|Superiority||Geometric Mean Ratio|0.8311||||0.0112|2-Sided|95.0|0.7208|0.9584|||Mixed Models Analysis|||Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683501|NCT01200394|3096710|Superiority||Geometric Mean Ratio|0.8759||||0.0382|2-Sided|95.0|0.7727|0.9927|||Mixed Models Analysis|||Week 3: Mixed model repeated measures (MMRM) on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.|
1683502|NCT01200394|3096711|Superiority|||||||0.2402||||||Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than or equal to 20% reduction in UACR compared to placebo.|ANCOVA|||ANCOVA model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic BP as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.|
1683503|NCT01200394|3096711|Superiority||Geometric Mean Ratio|0.843||||0.9889|2-Sided|95.0|0.728|0.975||Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than 0% reduction in UACR compared to placebo.|ANCOVA||Geometric mean ratio and corresponding 95% credible intervals were calculated.|Analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic blood pressure (BP) as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.|
1683504|NCT01200368|3096720|Superiority or Other||GMC ratio|0.8|||||2-Sided|95.0|0.7|0.91||||||GMC ratio for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.|
1683505|NCT01200368|3096720|Superiority or Other||GMC ratio|0.96|||||2-Sided|95.0|0.84|1.11||||||GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.|
1683506|NCT01200368|3096721|Superiority or Other||GMC ratio|1.0|||||2-Sided|95.0|0.85|1.19||||||GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.|
1683507|NCT01200368|3096721|Superiority or Other||GMC ratio|1.01|||||2-Sided|95.0|0.88|1.15||||||GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.|
1683672|NCT01197560|3097075|Superiority|||||||0.109|||||||Fisher Exact||||
1683509|NCT01200368|3096722|Superiority or Other||GMC ratio|0.98|||||2-Sided|95.0|0.87|1.1||||||GMC ratio for pertussis toxoid and corresponding 2-sided 95% CI were calculated.|
1683510|NCT01200368|3096723|Superiority or Other||GMC ratio|0.9|||||2-Sided|95.0|0.77|1.06||||||GMC ratio for tetanus toxoid and corresponding 2-sided 95% CI were calculated.|
1683511|NCT01200368|3096723|Superiority or Other||GMC ratio|1.1|||||2-Sided|95.0|0.97|1.24||||||GMC ratio for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.|
1683512|NCT01200368|3096724|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.|
1683513|NCT01200368|3096724|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.|
1683514|NCT01200368|3096724|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.|
1683515|NCT01200368|3096724|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-2.4|2.3||||||Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.|
1683516|NCT01200368|3096725|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|1.85|||||2-Sided|95.0|1.54|2.24||||||Serotype 19A: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683517|NCT01200368|3096725|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|1.26|||||2-Sided|95.0|1.04|1.52||||||Serotype 7F: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683518|NCT01200368|3096725|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|1.76|||||2-Sided|95.0|1.46|2.12||||||Serotype 6A: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683519|NCT01200368|3096725|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|1.28|||||2-Sided|95.0|1.07|1.54||||||Serotype 5: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683520|NCT01200368|3096725|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|0.29|||||2-Sided|95.0|0.24|0.35||||||Serotype 3: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683521|NCT01200368|3096725|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|1.62|||||2-Sided|95.0|1.31|1.99||||||Serotype 1: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683522|NCT01200368|3096725|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|0.86|||||2-Sided|95.0|0.7|1.07||||||Serotype 23F: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683523|NCT01200368|3096725|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|1.75|||||2-Sided|95.0|1.39|2.21||||||Serotype 19F: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683524|NCT01200368|3096725|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|0.82|||||2-Sided|95.0|0.67|1.01||||||Serotype 18C: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683525|NCT01200368|3096725|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|0.95|||||2-Sided|95.0|0.81|1.12||||||Serotype 14: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683526|NCT01200368|3096725|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|0.81|||||2-Sided|95.0|0.67|0.98||||||Serotype 9V: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683527|NCT01200368|3096725|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|1.23|||||2-Sided|95.0|0.98|1.53||||||Serotype 6B: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683528|NCT01200368|3096725|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|0.94|||||2-Sided|95.0|0.77|1.15||||||Serotype 4: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683529|NCT01200368|3096726|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.6|||||2-Sided|95.0|-1.7|3.6||||||Serotype 19A: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683547|NCT01200368|3096727|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|1.8|||||2-Sided|95.0|1.5|2.15||||||Serotype 1: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683530|NCT01200368|3096726|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.6|||||2-Sided|95.0|-1.7|3.6||||||Serotype 7F: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683531|NCT01200368|3096726|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.6|||||2-Sided|95.0|-1.7|3.6||||||Serotype 6A: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683532|NCT01200368|3096726|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.6|||||2-Sided|95.0|-1.7|3.6||||||Serotype 5: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683533|NCT01200368|3096726|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.0|||||2-Sided|95.0|-2.9|3.0||||||Serotype 3: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683534|NCT01200368|3096726|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.0|||||2-Sided|95.0|-2.9|3.0||||||Serotype 1: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683535|NCT01200368|3096726|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.0|||||2-Sided|95.0|-2.4|2.4||||||Serotype 23F: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.|
1683536|NCT01200368|3096726|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|-0.6|||||2-Sided|95.0|-3.9|2.4||||||Serotype 19F: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.|
1683537|NCT01200368|3096726|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.0|||||2-Sided|95.0|-2.4|2.4||||||Serotype 18C: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.|
1683538|NCT01200368|3096726|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.0|||||2-Sided|95.0|-2.4|2.4||||||Serotype 14: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.|
1683539|NCT01200368|3096726|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.0|||||2-Sided|95.0|-2.4|2.4||||||Serotype 9V: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.|
1683540|NCT01200368|3096726|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.0|||||2-Sided|95.0|-2.4|2.4||||||Serotype 6B: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.|
1683541|NCT01200368|3096726|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.0|||||2-Sided|95.0|-2.4|2.4||||||Serotype 4: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.|
1683542|NCT01200368|3096727|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|1.89|||||2-Sided|95.0|1.59|2.25||||||Serotype 19A: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683543|NCT01200368|3096727|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|1.83|||||2-Sided|95.0|1.54|2.16||||||Serotype 7F: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683544|NCT01200368|3096727|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|1.04|||||2-Sided|95.0|0.87|1.25||||||Serotype 6A: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683545|NCT01200368|3096727|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|1.03|||||2-Sided|95.0|0.86|1.22||||||Serotype 5: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683546|NCT01200368|3096727|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|1.08|||||2-Sided|95.0|0.92|1.28||||||Serotype 3: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI. GMC ratio was calculated using the serotype with the lowest GMC among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683673|NCT01197560|3097076|Superiority|||||||0.091|||||||Fisher Exact|||Pertains to all participants|
1683548|NCT01200368|3096728|Superiority or Other||Percent difference|-0.6|||||2-Sided|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for filamentous hemagglutinin and corresponding 2-sided 95% CI were calculated.|
1683549|NCT01200368|3096728|Superiority or Other||Percent difference|-0.6|||||2-Sided|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for pertussis toxoid and corresponding 2-sided 95% CI were calculated.|
1683550|NCT01200368|3096728|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-2.1|2.2||||||Difference in percentage of participants achieving predefined antibody levels for tetanus toxoid and corresponding 2-sided 95% CI were calculated.|
1683551|NCT01200368|3096728|Superiority or Other||Percent difference|-0.6|||||2-Sided|95.0|-3.1|1.6||||||Difference in percentage of participants achieving predefined antibody levels for diphtheria toxoid and corresponding 2-sided 95% CI were calculated.|
1683552|NCT01200368|3096729|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|0.8|||||2-Sided|95.0|0.66|0.98||||||Serotype 23F: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683553|NCT01200368|3096729|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|0.88|||||2-Sided|95.0|0.72|1.08||||||Serotype 19F: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683554|NCT01200368|3096729|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|0.73|||||2-Sided|95.0|0.63|0.85||||||Serotype 18C: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683555|NCT01200368|3096729|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|0.83|||||2-Sided|95.0|0.7|0.98||||||Serotype 14: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683556|NCT01200368|3096729|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|0.74|||||2-Sided|95.0|0.64|0.86||||||Serotype 9V: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683557|NCT01200368|3096729|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for IgG GMC ratio was >0.5.|GMC ratio|0.79|||||2-Sided|95.0|0.64|0.97||||||Serotype 6B: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683558|NCT01200368|3096729|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided, 95% CI for the IgG GMC ratio was >0.5.|GMC ratio|0.81|||||2-Sided|95.0|0.71|0.94||||||Serotype 4: Ratio of IgG GMCs ([13vPnC + DTaP]/[7vPnC + DTaP]) was calculated along with 2-sided 95% CI.|
1683559|NCT01200368|3096730|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|3.4|||||2-Sided|95.0|1.0|7.3||||||Serotype 19A: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683560|NCT01200368|3096730|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|3.4|||||2-Sided|95.0|0.9|7.3||||||Serotype 7F: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683561|NCT01200368|3096730|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|1.7|||||2-Sided|95.0|-1.9|5.8||||||Serotype 6A: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683562|NCT01200368|3096730|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|2.9|||||2-Sided|95.0|-0.2|6.7||||||Serotype 5: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683563|NCT01200368|3096730|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|2.9|||||2-Sided|95.0|-0.2|6.7||||||Serotype 3: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683564|NCT01200368|3096730|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|3.4|||||2-Sided|95.0|0.9|7.3||||||Serotype 1: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI. Difference in proportions was calculated using the serotype with the lowest proportion among the 7 common serotypes in the 7vPnC + DTaP group as reference.|
1683565|NCT01200368|3096730|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|-0.6|||||2-Sided|95.0|-4.2|2.9||||||Serotype 23F: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.|
1683566|NCT01200368|3096730|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|2.3|||||2-Sided|95.0|-1.1|6.3||||||Serotype 19F: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.|
1683567|NCT01200368|3096730|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.0|||||2-Sided|95.0|-2.1|2.1||||||Serotype 18C: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.|
1683568|NCT01200368|3096730|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.0|||||2-Sided|95.0|-2.1|2.1||||||Serotype 14: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.|
1683569|NCT01200368|3096730|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|0.0|||||2-Sided|95.0|-2.1|2.1||||||Serotype 9V: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.|
1683570|NCT01200368|3096730|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was >-0.10.|Percent difference|-1.7|||||2-Sided|95.0|-5.2|1.1||||||Serotype 6B: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95% CI.|
1683571|NCT01200368|3096730|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower confidence interval for the percent difference was greater than (>) -0.10.|Percent difference|0.0|||||2-Sided|95.0|-2.2|2.1||||||Serotype 4: Difference ([13vPnC + DTaP] – [7vPnC + DTaP]) in proportions, expressed as a percentage presented along with exact 2-sided 95 percent (%) confidence interval (CI).|
1683572|NCT01200290|3096746|Superiority or Other|||||||0.082||||||P-value is for Week 76.|Mixed Effect Model Repeat Measurement||||
1683573|NCT01200290|3096746|Superiority or Other|||||||0.095||||||P-value is for Week 64.|Mixed Effect Model Repeat Measurement||||
1683574|NCT01200290|3096746|Superiority or Other|||||||0.699||||||P-value is for Week 52.|Mixed Effect Model Repeat Measurement||||
1683575|NCT01200290|3096746|Superiority or Other|||||||0.004||||||P-value is for Week 36.|Mixed Effect Model Repeat Measurement||||
1683576|NCT01200290|3096746|Superiority or Other|||||||0.073||||||P-value is for Week 24.|Mixed Effect Model Repeat Measurement||||
1683577|NCT01200290|3096746|Superiority or Other|||||||0.043||||||P-value is for Week 16.|Mixed Effect Model Repeat Measurement||||
1683578|NCT01200290|3096746|Superiority or Other|||||||0.335||||||P-value is for Week 8.|Mixed Effect Model Repeat Measurement||||
1683579|NCT01200290|3096747|Superiority or Other|||||||0.23||||||P-value is for Week 76.|Mixed Effect Model Repeat Measurement||||
1683580|NCT01200290|3096747|Superiority or Other|||||||0.132||||||P-value is for Week 64.|Mixed Effect Model Repeat Measurement||||
1683581|NCT01200290|3096747|Superiority or Other|||||||0.553||||||P-value is for Week 52.|Mixed Effect Model Repeat Measurement||||
1683582|NCT01200290|3096747|Superiority or Other|||||||0.013||||||P-value is for Week 36.|Mixed Effect Model Repeat Measurement||||
1683583|NCT01200290|3096747|Superiority or Other|||||||0.076||||||P-value is for Week 24.|Mixed Effect Model Repeat Measurement||||
1683584|NCT01200290|3096747|Superiority or Other|||||||0.031||||||P-value is for Week 16.|Mixed Effect Model Repeat Measurement||||
1683585|NCT01200290|3096747|Superiority or Other|||||||0.324||||||P-value is for Week 8.|Mixed Effect Model Repeat Measurement||||
1683586|NCT01200030|3096765|Other|||||||0.055|||||||Kruskal-Wallis|||Null hypothesis: No significant differences existed between the percentage of change in reaching distance between the three groups.|
1683587|NCT01200030|3096766|Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||"Post-Hoc pairwise comparison comparing the effects of placebo stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups."|
1683588|NCT01200030|3096766|Other|||||||0.002||||||The p-value was adjusted for multiple comparisons. A p-value smaller than 0.05 indicated statistical significance.|Wilcoxon (Mann-Whitney)|||"Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and control group.~Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups."|
1683589|NCT01200030|3096766|Other|||||||1||||||The p-value was adjusted for multiple comparisons. A p-value smaller than 0.05 indicated statistical significance.|Wilcoxon (Mann-Whitney)|||Post-Hoc pairwise comparison comparing the effects of electrical stimulation with exercises group and placebo stimulation with exercises group. Null hypothesis: There was no significant difference existed on the changes of the Trunk Impairment Scale score between the two groups.|
1683590|NCT01200030|3096766|Other|The effect size of the intervention was adopted from a mate-analysis . The showed an average effect size of 0.59 in improving the motor control of limbs in people with stroke. A sample size for each group was set at 11 . Presuming that there would be a drop-out rate of 10% during the course of study, an extra 1 subject was recruited in each group. the sample size was 36. The statistical significance was set at 5% (alpha < 0.05) with power equal to 80%|||||<|0.001||||||Post-hoc pairwise comparisons have been conducted. Please refer to subsequent data analyses.|Kruskal-Wallis|||Null hypothesis: No significant differences existed between the percentage of change in Trunk Impairment Scale (TIS) score among the three groups.|
1683591|NCT01199861|3096789|Superiority or Other||Percent Inhibition|48.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.|
1683592|NCT01199861|3096789|Superiority or Other||Percent Inhibition|-28.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.|
1683639|NCT01197911|3097012|Superiority or Other||Geometric Least-Squares Mean Ratio|1.2323|||||2-Sided|90.0|0.9618|1.5789||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.|
1683674|NCT01197560|3097077|Superiority|||||||0.179|||||||Fisher Exact|||Pertains to non-GCB Sub-type; row 3|
1683593|NCT01199861|3096789|Superiority or Other||Percent Inhibition|38.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.|
1683594|NCT01199861|3096790|Superiority or Other||Percent Inhibition|44.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the B/Brisbane/60/2008 strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.|
1683595|NCT01199861|3096790|Superiority or Other||Percent Inhibition|-35.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as 'inhibition'.|The inhibition of an immune response to the A/Perth/16/2009 (H3N2) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.|
1683596|NCT01199861|3096790|Superiority or Other||Percent Inhibition|41.0||||||95.0|||||||One minus the back-transformed estimate for the treatment difference was interpreted as the relative inhibition of an immune response caused by fingolimod 0.5 mg compared to placebo; it was presented as a percentage and referred to as ‘inhibition'.|The inhibition of an immune response to the A/California/7/09 (H1N1) strain of the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.|
1683597|NCT01199705|3096831|Superiority or Other||Annualized Rate|0.0|||||1-Sided|99.0||0.802|||||||
1683598|NCT01199705|3096831|Superiority or Other||Annualized Rate|0.0|||||1-Sided|99.0||0.834|||||||
1683599|NCT01199705|3096831|Superiority or Other||Annualized Rate|0.0|||||1-Sided|99.0||1.204|||||||
1683600|NCT01199705|3096833|Superiority or Other||Annualized Rate|0.0|||||1-Sided|99.0||0.914|||||||
1683601|NCT01199705|3096833|Superiority or Other||Annualized Rate|0.0|||||1-Sided|99.0||0.953|||||||
1683602|NCT01199705|3096833|Superiority or Other||Annualized Rate|0.0|||||1-Sided|99.0||1.39|||||||
1683603|NCT01199601|3096838|Superiority or Other||Odds Ratio (OR)|1.13|Standard Deviation|0.05||0.05|2-Sided|95.0|1.01|1.25|||Regression, Logistic|The crude analysis result is provided as the odds ratio did not change substantially when adjusted for possible confounders.|||
1683604|NCT01199601|3096839|Superiority or Other||Incidence Rate Ratio|1.1|Standard Deviation|0.05|<|0.05|2-Sided|95.0|1.02|1.18|||Regression, Linear|Outcomes were assessed by crude and adjusted risk ratios with log-binomial generalized linear models.|||
1683605|NCT01199601|3096840|Superiority or Other||Incidence Rate Ratio|1.12|Standard Deviation|0.05|<|0.05|2-Sided|95.0|1.02|1.23|||Regression, Linear|Information provided for crude analysis results; adjustment for significant baseline differences between groups did not change results substantially.||Outcomes were assessed by crude and adjusted risk ratios with log-binomial generalized linear models.|
1683606|NCT01199237|3096862|Superiority or Other|||||||0.11||||||Significant at p<0.05|Chi-squared||||
1683607|NCT01198977|3096874|Non-Inferiority or Equivalence (legacy)|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.014||||||Comparing physical activity scores for the telephone counseling and education counseling groups at 6 months.|ANOVA||||
1683608|NCT01198977|3096874|Non-Inferiority or Equivalence (legacy)|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.049||||||Physical Activity Interaction effect between the Telephone Counseling and Education Counseling Group over time (baseline, 3 months, 6 months).|ANOVA||||
1683609|NCT01198977|3096875|Non-Inferiority or Equivalence (legacy)|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group X Time interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.032||||||Interaction effects between the telephone counseling and education counseling groups over time (baseline, 3 months, 6 months).|ANOVA||||
1683610|NCT01198977|3096875|Non-Inferiority or Equivalence (legacy)|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.009||||||Comparing depression scores for the telephone counseling and education counseling groups at 6 months.|ANOVA||||
1683638|NCT01197911|3097012|Superiority or Other||Geometric Least-Squares Mean Ratio|1.5587|||||2-Sided|90.0|1.2165|1.9971||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.|
1683611|NCT01198977|3096876|Non-Inferiority or Equivalence (legacy)|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.01||||||The interaction effect between the two conditions across time. Baseline, 3-month, 6-month.|ANOVA||||
1683612|NCT01198977|3096876|Non-Inferiority or Equivalence (legacy)|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.005||||||Comparing baseline to 6-month follow-up.|ANOVA||||
1683613|NCT01198977|3096876|Non-Inferiority or Equivalence (legacy)|Power analyses were conducted with GPower 3 evaluating the a priori sample size required to detect a medium-sized effect (f= .25, Cohen, 1988) for Group XTime interaction on primary DV. Assuming two-tailed alpha=.05 and autocorrelations between repeated measures of r=.50, adequate power (.80) to detect medium sized. Group Time effect (f=.25) would be achieved with a total sample size of 28. Given the sample size of 64, observed power more than adequate (.99).||||||0.013||||||Baseline and 3-month follow-up for arm 1 and arm 2.|ANOVA||||
1683614|NCT01198587|3096924|Superiority|||||||0.19|||||||Log Rank||||
1683615|NCT01198587|3096924|Superiority|||||||0.88|||||||Log Rank||||
1683616|NCT01198574|3096925|Superiority or Other||||||<|0.05|||||||GLM for repeated measures ANOVA|||"Null Hypothesis~iron status indicator (sTfR) was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~Vitamin A does not improve iron status indicator (sTfR) of the anaemic schoolgirls during iron supplementation in the presence of inflammation."|
1683617|NCT01198574|3096926|Superiority or Other||||||<|0.05|||||||GLM for repeated measures ANOVA|||"Null hypothesis~Iron status indicator (serum ferritin) was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~Vitamin A does not improve the iron status indicator (serum ferritin) concentration of the anaemic schoolgirls during iron supplementation in the presence of inflammation."|
1683618|NCT01198574|3096927|Superiority or Other||||||<|0.05|||||||GLM for repeated measures|The Hb concentration at Week 0, Week 6 and Week 12 are analyzed using GLM repeated measures.||"Null Hypothesis~Haemoglobin level was not influenced by sub-clinical inflammation during iron supplementation in the anaemic adolescent school girls~Vitamin A does not improve the haemoglobin level of the anaemic schoolgirls during iron supplementation in the presence of inflammation."|
1683619|NCT01198275|3096948|Superiority or Other||Hazard Ratio (HR)|0.441|||<|0.05|2-Sided|95.0|0.292|0.666|||Kaplan Meyer analysis|The time to first AF recurrence was analyzed with the Kaplan-Meier method and compared with the log-rank test.|Hazard ratios between n-3 PUFA and Placebo together with confidence intervals were estimated using the Cox proportional regression model.|Give a relapse rate ranging from 40% to 60% on ACE-I/ARB and amiodarone therapy, considering the high risk of relapses in our study population we conservatively assumed a 50% relapse rate. We calculated that a total of 180 patients would yield 80% power to detect a clinically relevant difference of about 20% in AF recurrence with the addition of n-3 PUFAs at a log-rank test, with a significance level of 0.05.|
1683620|NCT01198158|3096952|Superiority|||||||0.832|||||||Log Rank|PFS was analyzed based on an intent-to-treat approach using the stratified log-rank statistic adjusting on the stratification factors|||
1683621|NCT01198158|3096953|Superiority|||||||0.739|||||||Log Rank|OS was analyzed based on an intent-to-treat approach using the stratified log-rank statistic adjusting on the stratification factors.|||
1683622|NCT01198145|3096959|Superiority or Other (legacy)|||||||0.74|||||||Wilcoxon (Mann-Whitney)|||Result comparing Arm I and Arm II after RT.|
1683623|NCT01198145|3096959|Superiority or Other (legacy)|||||||0.56|||||||Wilcoxon (Mann-Whitney)|||Result comparing Arm I and Arm II during RT.|
1683624|NCT01198145|3096960|Superiority or Other (legacy)|||||||0.15|||||||Chi-squared||||
1683625|NCT01198145|3096960|Superiority or Other (legacy)|||||||0.38|||||||Chi-squared|||Comparing rectal bleeding during RT|
1683626|NCT01198145|3096960|Superiority or Other (legacy)|||||||0.48|||||||Chi-squared|||Comparing diarrhea after RT|
1683627|NCT01198145|3096960|Superiority or Other (legacy)|||||||0.44|||||||Chi-squared|||Comparing diarrhea during RT|
1683628|NCT01198145|3096960|Superiority or Other (legacy)|||||||0.63|||||||Chi-squared|||Comparing constipation after RT|
1683629|NCT01198145|3096960|Superiority or Other (legacy)|||||||0.7|||||||Chi-squared|||Comparing constipation during RT|
1683630|NCT01198145|3096960|Superiority or Other (legacy)|||||||0.02|||||||Chi-squared|||Comparing abdominal pain after RT|
1683631|NCT01198145|3096960|Superiority or Other (legacy)|||||||0.3|||||||Chi-squared|||Comparing abdominal pain during RT.|
1683632|NCT01198145|3096960|Superiority or Other (legacy)|||||||0.64|||||||Chi-squared|||Comparing Tenesmus after RT|
1683633|NCT01198145|3096960|Superiority or Other (legacy)|||||||0.23|||||||Chi-squared|||Comparing Tenesmus During RT|
1683634|NCT01198145|3096961|Superiority or Other (legacy)|||||||0.41|||||||Wilcoxon (Mann-Whitney)||||
1683635|NCT01198132|3096971|Superiority or Other||Rate ratio|0.8||||0.3797|2-Sided|95.0|0.48|1.32|||Poisson log-linear model||||
1683636|NCT01197911|3097011|Superiority or Other||GeometricLeast-Squares Mean Ratio|1.2254|||||2-Sided|90.0|0.9836|1.5266||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.|
1683637|NCT01197911|3097011|Superiority or Other||Geometric Least-Squares Mean Ratio|1.0027|||||2-Sided|90.0|0.8049|1.2492||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.|
1683675|NCT01197560|3097077|Superiority|||||||0.279|||||||Fisher Exact|||Pertains to GCB Subtype; row 2|
1683640|NCT01197911|3097026|Superiority or Other||Geometric Least-Squares Mean Ratio|1.0782|||||2-Sided|90.0|0.8941|1.3002||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One Participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.|
1683641|NCT01197911|3097026|Superiority or Other||Geometric Least-Squares Mean Ratio|0.9477|||||2-Sided|90.0|0.7908|1.1356||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.|
1683642|NCT01197911|3097028|Superiority or Other||Geometric Least-Squares Mean Ratio|1.5518|||||2-Sided|90.0|1.2468|1.9314||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available. One Participant with moderate hepatic impairment was not included in the statistical analysis of the PK parameters as there was no appropriate participant with normal hepatic function match.|
1683643|NCT01197911|3097028|Superiority or Other||Geometric Least-Squares Mean Ratio|1.148|||||2-Sided|90.0|0.9293|1.4182||||||This statistical analysis consisted of all evaluable hepatic impaired participants for whom at least one evaluable matching healthy participant was available.|
1683644|NCT01197755|3097042|Superiority or Other||Treatment difference|0.62||||0.516|2-Sided|95.0|-1.26|2.51|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683645|NCT01197755|3097042|Superiority or Other||Treatment difference|0.67||||0.487||95.0|-1.23|2.58|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683646|NCT01197755|3097043|Superiority or Other||Treatment difference|1.53||||0.118|2-Sided|95.0|-0.39|3.44|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683647|NCT01197755|3097043|Superiority or Other||Treatment difference|2.6||||0.009||95.0|0.65|4.56|||ANCOVA|Improvement from baseline, including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683648|NCT01197755|3097044|Superiority or Other|||||||0.019||||||Nominal p-value only. This was not included in the pre-defined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|ANCOVA|This was performed on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as covariate.|||
1683649|NCT01197755|3097044|Superiority or Other|||||||0.729||||||Nominal p-value only. This was not included in the pre-defined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|ANCOVA|This was performed on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as covariate.|||
1683650|NCT01197755|3097045|Superiority or Other||Odds Ratio (OR)|1.5||||0.186|2-Sided|95.0|0.82|2.79||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using logistic regression with treatment and pooled country as factors|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683651|NCT01197755|3097045|Superiority or Other||Odds Ratio (OR)|2.4||||0.004|2-Sided|95.0|1.33|4.45|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using logistic regression with treatment and pooled country as factors|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683652|NCT01197755|3097046|Superiority or Other||Odds Ratio (OR)|1.89||||0.028|2-Sided|95.0|1.07|3.31||Nominal p-value only. This was not included in the pre-defined multiplicity testing procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data|
1683653|NCT01197755|3097046|Superiority or Other||Odds Ratio (OR)|3.27|||<|0.001|2-Sided|95.0|1.86|5.76||Nominal p value only. This was not included in the pre-defined multiplicity testing procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data|
1683666|NCT01197755|3097053|Superiority or Other||Weighted difference in proportion|0.17||||0.004|2-Sided|95.0|0.05|0.28||Week 24|Mantel Haenszel|Treatment difference in proportion of responders at Week 24 with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683667|NCT01197560|3097070|Superiority|||||||0.211|||||||Log Rank||||
1683654|NCT01197755|3097047|Superiority or Other||Odds Ratio (OR)|4.7||||0.002|2-Sided|95.0|1.79|12.3||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683655|NCT01197755|3097047|Superiority or Other||Odds Ratio (OR)|4.1||||0.005|2-Sided|95.0|1.54|10.92|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683656|NCT01197755|3097048|Superiority or Other||Odds Ratio (OR)|2.3||||0.197|2-Sided|95.0|0.65|8.23||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683657|NCT01197755|3097048|Superiority or Other||Odds Ratio (OR)|4.1||||0.023|2-Sided|95.0|1.21|13.91|||Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio of >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683658|NCT01197755|3097049|Superiority or Other|||||||0.019||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683659|NCT01197755|3097049|Superiority or Other|||||||0.01||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683660|NCT01197755|3097050|Superiority or Other||Weighted difference in proportion|0.0||||0.891|2-Sided|95.0|-0.04|0.04||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683661|NCT01197755|3097050|Superiority or Other||Weighted difference in proportion|0.12|||<|0.001|2-Sided|95.0|0.06|0.19|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683662|NCT01197755|3097051|Superiority or Other||Weighted difference in proportion|0.05||||0.18|2-Sided|95.0|-0.02|0.12||Nominal p-value presented for Group B comparison. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (primary variable comparison of Group B versus Group C was non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683663|NCT01197755|3097051|Superiority or Other||Weighted difference in proportion|0.1||||0.014|2-Sided|95.0|0.02|0.19|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683664|NCT01197755|3097052|Superiority or Other||Weighted difference in proportion|0.22|||<|0.001|2-Sided|95.0|0.16|0.29|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683665|NCT01197755|3097053|Superiority or Other||Weighted difference in proportion|0.07||||0.168|2-Sided|95.0|-0.03|0.18||Week 24|Mantel Haenszel|Treatment difference in proportion of responders at Week 24 with a Mantel-Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683668|NCT01197560|3097071|Superiority|||||||0.02|||||||Log Rank||||
1683669|NCT01197560|3097072|Superiority|||||||0.972|||||||Log Rank||||
1683670|NCT01197560|3097073|Superiority|||||||0.529|||||||Log Rank||||
1683676|NCT01197560|3097077|Superiority|||||||0.079|||||||Fisher Exact|||Pertains to all participants; row 1|
1683677|NCT01197534|3097081|Superiority or Other||Treatment difference|1.96|||<|0.001|2-Sided|95.0|0.83|3.08||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683678|NCT01197534|3097081|Superiority or Other||Treatment difference|2.09|||<|0.001|2-Sided|95.0|0.97|3.2||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683679|NCT01197534|3097082|Superiority or Other||Treatment difference|1.64||||0.001|2-Sided|95.0|0.63|2.65||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683680|NCT01197534|3097082|Superiority or Other||Treatment difference|2.47|||<|0.001|2-Sided|95.0|1.47|3.48||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as continuous covariate and treatment, background use of DMARD and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683681|NCT01197534|3097083|Superiority or Other|||||||0.342||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Cochran-Mantel-Haenszel|Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.|
1683682|NCT01197534|3097083|Superiority or Other|||||||0.904||||||As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Cochran-Mantel-Haenszel|Residuals from ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country and background use of DMARD.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country and background use of DMARD, including a term for the ranks of the baseline score as a covariate.|
1683683|NCT01197534|3097084|Superiority or Other||Odds Ratio (OR)|2.1|||<|0.001|2-Sided|95.0|1.46|2.94|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683684|NCT01197534|3097084|Superiority or Other||Odds Ratio (OR)|2.4|||<|0.001|2-Sided|95.0|1.73|3.46|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683685|NCT01197534|3097085|Superiority or Other||Odds Ratio (OR)|2.44|||<|0.001|2-Sided|95.0|1.77|3.37||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.|An odds ratio > 1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683686|NCT01197534|3097085|Superiority or Other||Odds Ratio (OR)|2.84|||<|0.001|2-Sided|95.0|2.06|3.91||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No Response, moderate response and good response are included in the model, with treatment, background use of DMARD and pooled country as factors.|An odds ratio > 1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683687|NCT01197534|3097086|Superiority or Other||Odds Ratio (OR)|6.4|||<|0.001|2-Sided|95.0|2.81|14.71|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683688|NCT01197534|3097086|Superiority or Other||Odds Ratio (OR)|7.3|||<|0.001|2-Sided|95.0|3.23|16.65|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683863|NCT01196078|3097326|Superiority or Other|||||||0.3581|||||||ANOVA|||LCS, Baseline versus Endpoint|
1683689|NCT01197534|3097087|Superiority or Other||Odds Ratio (OR)|4.0|||<|0.001|2-Sided|95.0|1.88|8.65|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683690|NCT01197534|3097087|Superiority or Other||Odds Ratio (OR)|7.1|||<|0.001|2-Sided|95.0|3.42|14.8|||Regression, Logistic|Odds ratio and 95% confidence intervals calculated using Logistic Regression with treatment, background use of DMARD and pooled country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683691|NCT01197534|3097088|Superiority or Other||||||<|0.001||||||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683692|NCT01197534|3097088|Superiority or Other||||||<|0.001||||||Nominal p-value presented for treatment comparison. Outcome was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test, p-values alone are presented rather than an estimated treatment difference.|Van Elteren|P-values are estimated using the Van Elteren test stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683693|NCT01197534|3097089|Superiority or Other||Weighted difference in proportions|0.03||||0.033|2-Sided|95.0|0.0|0.07|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683694|NCT01197534|3097089|Superiority or Other||Weighted difference in proportions|0.07|||<|0.001|2-Sided|95.0|0.03|0.1|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683695|NCT01197534|3097090|Superiority or Other||Weighted difference in proportions|0.1|||<|0.001|2-Sided|95.0|0.05|0.15|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683696|NCT01197534|3097090|Superiority or Other||Weighted difference in proportions|0.13|||<|0.001|2-Sided|95.0|0.07|0.18|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683697|NCT01197534|3097091|Superiority or Other||Weighted difference in proportion|0.08|||<|0.001|2-Sided|95.0|0.04|0.12|||Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683698|NCT01197534|3097092|Superiority or Other||Weighted difference in proportions|0.15|||<|0.001|2-Sided|95.0|0.08|0.22||Week 24|Mantel Haenszel|Treatment difference in proportion of responders using a Mantel Haenszel approach stratified by background use of DMARD and pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of DMARD or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683699|NCT01197521|3097093|Superiority or Other||Treatment difference|1.56||||0.017||95.0|0.28|2.83||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683700|NCT01197521|3097093|Superiority or Other||Treatment difference|1.8||||0.005||95.0|0.54|3.07||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683701|NCT01197521|3097094|Superiority or Other||Treatment difference|1.27||||0.02||95.0|0.2|2.35||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683864|NCT01196078|3097326|Superiority or Other|||||||0.9927|||||||ANOVA|||FWB, Baseline versus Endpoint|
1683865|NCT01196078|3097326|Superiority or Other|||||||0.5104|||||||ANOVA|||EWB Baseline versus Endpoint|
1683702|NCT01197521|3097094|Superiority or Other||Treatment difference|2.24|||<|0.001||95.0|1.16|3.31||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|ANCOVA|Including terms for baseline as a continuous covariate and treatment and pooled country as factors.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683703|NCT01197521|3097095|Superiority or Other||Odds Ratio (OR)|1.9|||<|0.001|2-Sided|95.0|1.38|2.68||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio >1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683704|NCT01197521|3097095|Superiority or Other||Odds Ratio (OR)|2.3|||<|0.001|2-Sided|95.0|1.68|3.26||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio >1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683705|NCT01197521|3097096|Superiority or Other||Odds Ratio (OR)|1.57||||0.004|2-Sided|95.0|1.16|2.14||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio >1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683706|NCT01197521|3097096|Superiority or Other||Odds Ratio (OR)|2.43|||<|0.001|2-Sided|95.0|1.79|3.3||Nominal p-value presented for treatment comparison. This was not formally tested within the predefined multiplicity procedure.|Proportional odds model|No response, moderate response and good response are included in the proportional odds model with treatment and pooled country as factors.|An odds ratio >1 indicates a benefit towards fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683707|NCT01197521|3097097|Superiority or Other||Odds Ratio (OR)|1.8||||0.083|2-Sided|95.0|0.93|3.5||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio >1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683708|NCT01197521|3097097|Superiority or Other||Odds Ratio (OR)|3.0|||<|0.001|2-Sided|95.0|1.63|5.67||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio >1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683709|NCT01197521|3097098|Superiority or Other||Odds Ratio (OR)|4.4||||0.002|2-Sided|95.0|1.76|11.02||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio >1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683710|NCT01197521|3097098|Superiority or Other||Odds Ratio (OR)|6.0|||<|0.001|2-Sided|95.0|2.44|14.64||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Regression, Logistic|Odds ratio and 95% confidence intervals are calculated using Logistic Regression with treatment and pooled country as factors.|An odds ratio >1 indicates a benefit towards Fostamatinib.|Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683711|NCT01197521|3097099|Superiority or Other|||||||0.002||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|The treatment differences, 95% CIs and p-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683725|NCT01197508|3097105|Superiority or Other||LS mean|-0.006|Standard Error of the Mean|0.0188||0.743|2-Sided|95.0|-0.0432|0.0308||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683712|NCT01197521|3097099|Superiority or Other||||||<|0.001||||||Nominal p-value presented for treatment comparison. ACRn was not formally tested within the predefined multiplicity procedure. As this is a non-parametric test p-values alone are presented rather than an estimated treatment difference.|Van Elteren|The treatment differences, 95% CIs and p-values are estimated using the Van Elteren test stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683713|NCT01197521|3097100|Superiority or Other||Weighted difference in proportions|0.04||||0.015|2-Sided|95.0|0.01|0.07||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683714|NCT01197521|3097100|Superiority or Other||Weighted difference in proportions|0.08|||<|0.001|2-Sided|95.0|0.05|0.12||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683715|NCT01197521|3097101|Superiority or Other||Weighted difference in proportions|0.09||||0.002|2-Sided|95.0|0.03|0.14||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683716|NCT01197521|3097101|Superiority or Other||Weighted difference in proportions|0.16|||<|0.001|2-Sided|95.0|0.11|0.22||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683717|NCT01197521|3097102|Superiority or Other||Weighted difference in proportion|0.13|||<|0.001|2-Sided|95.0|0.1|0.17||Nominal p-values presented. Formal statistical testing could not be carried out due to the predefined multiplicity procedure (as the primary variable comparisons were non-significant).|Mantel Haenszel|95% confidence intervals and p-values are calculated using a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683718|NCT01197521|3097103|Superiority or Other|||||||0.17||||||Week 24|Cochran-Mantel-Haenszel|The residuals from the ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as a covariate.|
1683719|NCT01197521|3097103|Superiority or Other|||||||0.252||||||Week 24|Cochran-Mantel-Haenszel|The residuals from the ANCOVA are analysed using a Cochran-Mantel-Haenszel approach, adjusting for the effects of pooled country.||This analysis is performed using an ANCOVA model on the ranks of the change from baseline, by pooled country, including a term for the ranks of the baseline score as a covariate.|
1683720|NCT01197521|3097104|Superiority or Other||Weighted difference in proportions|0.1||||0.006|2-Sided|95.0|0.03|0.18||Week 24|Mantel Haenszel|Treatment difference in proportion of responders with a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683721|NCT01197521|3097104|Superiority or Other||Weighted difference in proportions|0.15|||<|0.001|2-Sided|95.0|0.08|0.22||Week 24|Mantel Haenszel|Treatment difference in proportion of responders with a Mantel Haenszel approach stratified by pooled country.||Non-responder imputation has been applied following premature withdrawal, or increased dose of methotrexate or any DMARD initiation, or for 8 weeks following receipt of any parenteral steroids, or for patients with no post baseline data.|
1683722|NCT01197508|3097105|Superiority or Other||LS mean|-2.8|Standard Error of the Mean|2.02||0.165|2-Sided|95.0|-6.79|1.16||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683723|NCT01197508|3097105|Superiority or Other||LS mean|-1.7|Standard Error of the Mean|1.98||0.389|2-Sided|95.0|-5.59|2.18||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683724|NCT01197508|3097105|Superiority or Other||LS mean|-2.3|Standard Error of the Mean|1.95||0.244|2-Sided|95.0|-6.1|1.56||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683861|NCT01196117|3097281|Superiority|||||||0.0009|||||||Wilcoxon (Mann-Whitney)||||
1683726|NCT01197508|3097105|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.0183||0.998|2-Sided|95.0|-0.036|0.0361||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683727|NCT01197508|3097105|Superiority or Other||LS mean|-0.011|Standard Error of the Mean|0.0181||0.543|2-Sided|95.0|-0.0465|0.0245||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683728|NCT01197508|3097106|Superiority or Other||LS mean|-0.2|Standard Error of the Mean|0.1||0.033|2-Sided|95.0|-0.41|-0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.|
1683729|NCT01197508|3097106|Superiority or Other||LS mean|-0.2|Standard Error of the Mean|0.1||0.078|2-Sided|95.0|-0.37|0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.|
1683730|NCT01197508|3097106|Superiority or Other||LS mean|-0.1|Standard Error of the Mean|0.1||0.152|2-Sided|95.0|-0.33|0.05|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.|
1683731|NCT01197508|3097107|Superiority or Other||LS mean|-0.2|Standard Error of the Mean|0.1||0.067|2-Sided|95.0|-0.37|0.01|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1683732|NCT01197508|3097107|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.1||0.885|2-Sided|95.0|-0.18|0.21|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1683733|NCT01197508|3097107|Superiority or Other||LS mean|-0.1|Standard Error of the Mean|0.1||0.312|2-Sided|95.0|-0.29|0.09|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1683734|NCT01197508|3097108|Superiority or Other||LS mean|-2.71|Standard Error of the Mean|1.672||0.105|2-Sided|95.0|-5.992|0.573|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1683735|NCT01197508|3097108|Superiority or Other||LS mean|-1.32|Standard Error of the Mean|1.672||0.432|2-Sided|95.0|-4.597|1.967|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1683736|NCT01197508|3097108|Superiority or Other||LS mean|-1.47|Standard Error of the Mean|1.643||0.371|2-Sided|95.0|-4.697|1.756|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1683737|NCT01197508|3097109|Superiority or Other||LS mean|0.3|Standard Error of the Mean|0.27||0.197|2-Sided|95.0|-0.18|0.88|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.|
1683738|NCT01197508|3097109|Superiority or Other||LS mean|0.2|Standard Error of the Mean|0.27||0.402|2-Sided|95.0|-0.3|0.74|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.|
1683739|NCT01197508|3097109|Superiority or Other||LS mean|0.4|Standard Error of the Mean|0.26||0.174|2-Sided|95.0|-0.16|0.87|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.|
1683740|NCT01197508|3097110|Superiority or Other||LS mean|0.2|Standard Error of the Mean|0.27||0.441|2-Sided|95.0|-0.32|0.74|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683741|NCT01197508|3097110|Superiority or Other||LS mean|0.2|Standard Error of the Mean|0.27||0.498|2-Sided|95.0|-0.34|0.7|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683742|NCT01197508|3097110|Superiority or Other||LS mean|0.3|Standard Error of the Mean|0.26||0.248|2-Sided|95.0|-0.21|0.82|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683743|NCT01197508|3097111|Superiority or Other||LS mean|0.1|Standard Error of the Mean|0.31||0.656|2-Sided|95.0|-0.47|0.75|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683744|NCT01197508|3097111|Superiority or Other||LS mean|0.2|Standard Error of the Mean|0.3||0.446|2-Sided|95.0|-0.36|0.81|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683745|NCT01197508|3097111|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.29||0.914|2-Sided|95.0|-0.54|0.61|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683746|NCT01197508|3097112|Superiority or Other||LS mean|0.85|Standard Error of the Mean|0.762||1|2-Sided|95.0|-0.649|2.346||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683747|NCT01197508|3097112|Superiority or Other||LS mean|0.72|Standard Error of the Mean|0.746||1|2-Sided|95.0|-0.74|2.188||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683748|NCT01197508|3097112|Superiority or Other||LS mean|0.98|Standard Error of the Mean|0.736||1|2-Sided|95.0|-0.464|2.427||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683749|NCT01197508|3097113|Superiority or Other||LS mean|1.3|Standard Error of the Mean|0.77||0.087|2-Sided|95.0|-0.19|2.84|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683750|NCT01197508|3097113|Superiority or Other||LS mean|0.3|Standard Error of the Mean|0.75||0.681|2-Sided|95.0|-1.17|1.79|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683751|NCT01197508|3097113|Superiority or Other||LS mean|1.5|Standard Error of the Mean|0.75||0.046|2-Sided|95.0|0.02|2.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.|
1683752|NCT01197508|3097114|Superiority or Other||LS mean|1.0|Standard Error of the Mean|0.71||0.167|2-Sided|95.0|-0.41|2.38|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683753|NCT01197508|3097114|Superiority or Other||LS mean|0.3|Standard Error of the Mean|0.7||0.712|2-Sided|95.0|-1.11|1.63|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683754|NCT01197508|3097114|Superiority or Other||LS mean|0.6|Standard Error of the Mean|0.69||0.394|2-Sided|95.0|-0.77|1.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683755|NCT01197508|3097115|Superiority or Other||LS mean|1.0|Standard Error of the Mean|0.62||0.099|2-Sided|95.0|-0.19|2.24|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683756|NCT01197508|3097115|Superiority or Other||LS mean|0.1|Standard Error of the Mean|0.61||0.874|2-Sided|95.0|-1.11|1.3|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683757|NCT01197508|3097115|Superiority or Other||LS mean|1.2|Standard Error of the Mean|0.61||0.052|2-Sided|95.0|-0.01|2.38|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683758|NCT01197508|3097116|Superiority or Other||LS mean|0.6|Standard Error of the Mean|0.48||0.215|2-Sided|95.0|-0.35|1.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683759|NCT01197508|3097116|Superiority or Other||LS mean|0.2|Standard Error of the Mean|0.48||0.679|2-Sided|95.0|-0.74|1.14|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683760|NCT01197508|3097116|Superiority or Other||LS mean|0.3|Standard Error of the Mean|0.47||0.59|2-Sided|95.0|-0.68|1.19|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683761|NCT01197508|3097117|Superiority or Other||LS mean|1.2|Standard Error of the Mean|0.67||0.078|2-Sided|95.0|-0.13|2.51|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1683866|NCT01196078|3097326|Superiority or Other|||||||0.6871|||||||ANOVA|||SWB, Baseline versus Endpoint|
1683762|NCT01197508|3097117|Superiority or Other||LS mean|0.7|Standard Error of the Mean|0.67||0.315|2-Sided|95.0|-0.65|2.0|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1683763|NCT01197508|3097117|Superiority or Other||LS mean|0.7|Standard Error of the Mean|0.66||0.273|2-Sided|95.0|-0.58|2.03|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1683764|NCT01197508|3097118|Superiority or Other||Odds Ratio (OR)|0.6|Standard Error of the Mean|0.15||0.04|2-Sided|95.0|0.37|0.98|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.|
1683765|NCT01197508|3097118|Superiority or Other||Odds Ratio (OR)|0.62|Standard Error of the Mean|0.15||0.051|2-Sided|95.0|0.38|1.0|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.|
1683766|NCT01197508|3097118|Superiority or Other||Odds Ratio (OR)|0.62|Standard Error of the Mean|0.15||0.046|2-Sided|95.0|0.38|0.99|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.|
1683767|NCT01197508|3097119|Superiority or Other||LS mean|0.1|Standard Error of the Mean|0.12||0.645|2-Sided|95.0|-0.19|0.3|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683768|NCT01197508|3097119|Superiority or Other||LS mean|0.1|Standard Error of the Mean|0.12||0.551|2-Sided|95.0|-0.17|0.31|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683769|NCT01197508|3097119|Superiority or Other||LS mean|0.2|Standard Error of the Mean|0.12||0.131||95.0|-0.05|0.42|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683770|NCT01197508|3097120|Superiority or Other||LS mean|2.09|Standard Error of the Mean|0.711||0.003|2-Sided|95.0|0.692|3.484|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1683771|NCT01197508|3097120|Superiority or Other||LS mean|0.95|Standard Error of the Mean|0.715||0.184|2-Sided|95.0|-0.452|2.354|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1683772|NCT01197508|3097120|Superiority or Other||LS mean|1.1|Standard Error of the Mean|0.705||0.12|2-Sided|95.0|-0.288|2.481|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1683773|NCT01197508|3097121|Superiority or Other||Odds Ratio (OR)|0.61|Standard Error of the Mean|0.26||0.239|2-Sided|95.0|0.26|1.39|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683774|NCT01197508|3097121|Superiority or Other||Odds Ratio (OR)|0.92|Standard Error of the Mean|0.37||0.841|2-Sided|95.0|0.42|2.01|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683775|NCT01197508|3097121|Superiority or Other||Odds Ratio (OR)|1.04|Standard Error of the Mean|0.41||0.913|2-Sided|95.0|0.48|2.27|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683776|NCT01197508|3097122|Superiority or Other||Odds Ratio (OR)|0.52|Standard Error of the Mean|0.17||0.042|2-Sided|95.0|0.28|0.98|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683777|NCT01197508|3097122|Superiority or Other||Odds Ratio (OR)|0.69|Standard Error of the Mean|0.21||0.222|2-Sided|95.0|0.38|1.25|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683778|NCT01197508|3097122|Superiority or Other||Odds Ratio (OR)|0.52|Standard Error of the Mean|0.16||0.037|2-Sided|95.0|0.28|0.96|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683779|NCT01197508|3097123|Superiority or Other||Odds Ratio (OR)|1.15|Standard Error of the Mean|0.49||0.749|2-Sided|95.0|0.5|2.65|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683780|NCT01197508|3097123|Superiority or Other||Odds Ratio (OR)|0.79|Standard Error of the Mean|0.34||0.594|2-Sided|95.0|0.34|1.85|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683781|NCT01197508|3097123|Superiority or Other||Odds Ratio (OR)|0.85|Standard Error of the Mean|0.37||0.711|2-Sided|95.0|0.36|1.99|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683782|NCT01197508|3097124|Superiority or Other||Odds Ratio (OR)|0.58|Standard Error of the Mean|0.15||0.034|2-Sided|95.0|0.35|0.96|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683783|NCT01197508|3097124|Superiority or Other||Odds Ratio (OR)|0.73|Standard Error of the Mean|0.19||0.215|2-Sided|95.0|0.44|1.2|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683784|NCT01197508|3097124|Superiority or Other||Odds Ratio (OR)|0.89|Standard Error of the Mean|0.22||0.636|2-Sided|95.0|0.54|1.45|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683785|NCT01197508|3097125|Superiority or Other||Odds Ratio (OR)|0.52|Standard Error of the Mean|0.12||0.005|2-Sided|95.0|0.32|0.82|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683786|NCT01197508|3097125|Superiority or Other||Odds Ratio (OR)|0.74|Standard Error of the Mean|0.17||0.203|2-Sided|95.0|0.47|1.17|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683787|NCT01197508|3097125|Superiority or Other||Odds Ratio (OR)|0.71|Standard Error of the Mean|0.17||0.144|2-Sided|95.0|0.45|1.12|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1683788|NCT01197508|3097126|Superiority or Other||LS mean|0.5|Standard Error of the Mean|0.88||1|2-Sided|95.0|-1.21|2.22|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683789|NCT01197508|3097126|Superiority or Other||LS mean|0.5|Standard Error of the Mean|0.85||1|2-Sided|95.0|-1.22|2.13|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683790|NCT01197508|3097126|Superiority or Other||LS mean|1.1|Standard Error of the Mean|0.84||1|2-Sided|95.0|-0.53|2.79||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1683791|NCT01197417|3097134|Superiority or Other|||||||0.46|||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.|||
1683792|NCT01197417|3097135|Superiority or Other|||||||0.78|||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.|||
1683793|NCT01197417|3097136|Superiority or Other|||||||0.11|||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.|||
1683794|NCT01197417|3097137|Superiority or Other||||||<|0.01|||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.|||
1683795|NCT01197417|3097138|Superiority or Other|||||||0.39|||||||Mantel Haenszel|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.|||
1683796|NCT01197417|3097139|Superiority or Other|||||||0.12|||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment.|||
1683797|NCT01197417|3097140|Superiority or Other|||||||0.24|||||||Van Elteren test|Randomization strata were defined by enrollment site, age group and hydroxyurea use within the last three months prior to enrollment||Null hypothesis of equal distributions of primary length of stay between treatment arms within all randomization strata|
1683798|NCT01197300|3097146|Other|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.11||||0.2694|2-Sided|95.0|-0.32|0.1||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Extension baseline bone age as explanatory variables and pooled centers as random effect.|ANCOVA|||2nd metacarpal cortical width chge from BL2 at Month 24|
1683799|NCT01197300|3097146|Other|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group - LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.01||||0.9231|2-Sided|95.0|-0.18|0.17||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline bone age as explanatory variables and pooled centers as random effect.|ANCOVA|||2nd metacarpal cortical width chge from BL1 at Month 24|
1683800|NCT01197300|3097147|Other||Odds Ratio (OR)|1.31||||0.875|2-Sided|95.0|0.05|38.04||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 24|
1683801|NCT01197300|3097147|Other||Odds Ratio (OR)|0.01||||0.6046|2-Sided|95.0|0.01|999.99||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 21|
1683802|NCT01197300|3097147|Other||Odds Ratio (OR)|0.01||||0.6046|2-Sided|95.0|0.01|999.99||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 18|
1683803|NCT01197300|3097147|Other||Odds Ratio (OR)|4.73||||0.3971|2-Sided|95.0|0.13|173.07||Presented by treatment group and evaluated using a logistic regression model with Core treatment, pooled centers, underlying condition treated with glucocorticoids and Core baseline pain score as explanatory variables.|Regression, Logistic|||Reduction in Pain at Month 15|
1683804|NCT01197300|3097148|Other|The number and percentage of patients with new morphometric vertebral fractures during the 12 month extension period was presented by core treatment group. Between-treatment differences will be evaluated using Fisher’s exact test.||||||1|||||||Fisher Exact|||New morphometric vertebral fractures at Month 12 Extension|
1683805|NCT01197300|3097149|Other|The number and percentage of patients with new vertebral fractures during the 12 month Extension period was presented by Core treatment group. Between-treatment differences were evaluated using Fisher’s exact test.||||||1|||||||Fisher Exact|||New vertebral fractures at Month 12 Extension|
1683806|NCT01197300|3097150|Other|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|-0.41||||0.9236|2-Sided|95.0|-2.423|1.603||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum TRAP-5b Change at Month 24|
1683807|NCT01197300|3097150|Other|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|-1.482||||0.46|2-Sided|95.0|-3.805|0.841||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum TRAP-5b Change at Month 18|
1683808|NCT01197300|3097151|Other|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|-2.558||||0.9472|2-Sided|95.0|-8.864|3.747||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum NTX Change at Month 24|
1683809|NCT01197300|3097151|Other|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|-4.661||||0.9009|2-Sided|95.0|-16.647|7.325||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum NTX Change at Month 18|
1683810|NCT01197300|3097152|Other|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|-3.662||||0.4852|2-Sided|95.0|-21.479|14.155||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||BSAP Change at Month 24|
1683811|NCT01197300|3097152|Other|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|-17.691||||0.2123|2-Sided|95.0|-41.925|6.543||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||BSAP Change at Month 18|
1683812|NCT01197300|3097153|Other|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|-132.437||||0.1266|2-Sided|95.0|-286.452|21.579||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum P1NP Change at Month 24|
1683813|NCT01197300|3097153|Other|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|-147.68||||0.4143|2-Sided|95.0|-394.41|99.049||An analysis of covariance (ANCOVA) model was performed on the transformed data with Core treatment, pooled centers, underlying condition treated with glucocorticoids and loge as explanatory variables and pooled centers as random effect.|ANCOVA|The transformed data was calculated by dividing the post-baseline value by the baseline value and then applying the loge transformation||Serum P1NP Change at Month 18|
1683814|NCT01197300|3097154|Superiority|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|65.674||||0.7347|2-Sided|95.0|-344.067|475.415||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Total body BMC Change at Month 24|
1683862|NCT01196104|3097308|Non-Inferiority or Equivalence|Study terminated early due to business reasons, results are not properly powered.|Mean Difference (Final Values)|-0.0473|Standard Error of the Mean|0.2158||0.8283|2-Sided|95.0|-0.4901|0.3956|||ANCOVA|||ANCOVA model with terms of treatment as a fixed effect and baseline HbA1c as covariate|
1683815|NCT01197300|3097154|Superiority|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|121.129||||0.531|2-Sided|95.0|-291.0|533.258||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Total body BMC Change at Month 18|
1683816|NCT01197300|3097155|Superiority|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|1.179||||0.705|2-Sided|95.0|-5.281|7.639||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMC Change at Month 24|
1683817|NCT01197300|3097155|Superiority|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|2.36||||0.3544|2-Sided|95.0|-2.886|7.606||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMC Change at Month 18|
1683818|NCT01197300|3097156|Superiority|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|21.752||||0.218|2-Sided|95.0|-14.126|57.63||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMD Z-score Change at Month 24|
1683819|NCT01197300|3097156|Superiority|Difference in least squares mean = LS mean for the Core treatment Zoledronic acid group — LS mean for the Core treatment Placebo group.|Difference in LS mean|3.7||||0.8505|2-Sided|95.0|-37.242|44.642||An analysis of covariance (ANCOVA) model was performed with Core treatment, pooled centers, underlying condition treated with GCs and Core baseline lumbar spine BMD Z-score as explanatory variables and pooled centers as random effect.|ANCOVA|||Lumbar Spine BMD Z-score Change at Month 18|
1683820|NCT01196936|3097210|Superiority|||||||0.8315|||||||Mixed Models Analysis||||
1683821|NCT01196936|3097211|Superiority|||||||0.739|||||||Mixed Models Analysis||||
1683822|NCT01196936|3097212|Superiority|||||||0.071|||||||Mixed Models Analysis||||
1683823|NCT01196936|3097213|Superiority||||||>|0.05|||||||Chi-squared||||
1683824|NCT01196936|3097214|Superiority|||||||0.78|||||||Wilcoxon (Mann-Whitney)||||
1683825|NCT01196936|3097215|Superiority||||||>|0.05|||||||Mixed Models Analysis||||
1683826|NCT01196936|3097216|Superiority|||||||0.12|||||||Fisher Exact||||
1683827|NCT01196936|3097217|Superiority|||||||0.0266|||||||Mixed Models Analysis||||
1683828|NCT01196936|3097218|Superiority|||||||0.05||||||The calculated p-value is 0.05.|Mixed Models Analysis||||
1683829|NCT01196871|3097222|Other|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß*Treatment + Error.|Cmax Ratio|0.997|||||2-Sided|90.0|0.791|1.259|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.|
1683830|NCT01196871|3097223|Other|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß*Treatment + Error.|AUCinfinity Ratio|1.052|||||2-Sided|90.0|0.807|1.371|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.|
1683831|NCT01196871|3097223|Other|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß*Treatment + Error.|AUC0-t Ratio|1.059|||||2-Sided|90.0|0.818|1.371|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.|
1683832|NCT01196871|3097225|Other|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß*Treatment + Error.|Cmax Ratio|1.063|||||2-Sided|90.0|0.972|1.164|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.|
1683833|NCT01196871|3097225|Other|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß*Treatment + Error.|Cmax Ratio|1.034|||||2-Sided|90.0|0.929|1.152|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.|
1683834|NCT01196871|3097227|Other|Geometric means for each treatment combination is obtained from the linear mixed effects mode Log (parameter) = Intercept + ß*Treatment + Error.|AUC0-t Ratio|1.256|||||2-Sided|90.0|1.026|1.538|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.|
1683835|NCT01196871|3097227|Other|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß*Treatment + Error.|AUC0-t Ratio|1.025|||||2-Sided|90.0|0.921|1.14|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.|
1683836|NCT01196871|3097229|Other|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß*Treatment + Error.|Cmax Ratio|1.546|||||2-Sided|90.0|1.3|1.838|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.|
1683837|NCT01196871|3097229|Other|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß*Treatment + Error.|Cmax Ratio|1.629|||||2-Sided|90.0|1.44|1.843|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 Cmax Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.|
1683838|NCT01196871|3097230|Other|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß*Treatment + Error.|AUCinfinity Ratio|2.375|||||2-Sided|90.0|1.839|3.068|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.|
1683839|NCT01196871|3097230|Other|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß*Treatment + Error.|AUC0-t Ratio|2.354|||||2-Sided|90.0|1.826|3.035|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 2 AUC0-t Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.|
1683840|NCT01196871|3097230|Other|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß*Treatment + Error.|AUCinfinity Ratio|2.942|||||2-Sided|90.0|2.431|3.56|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUCinfinity Data: Point estimates for the geometric means and their 90% CI are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.|
1683841|NCT01196871|3097230|Other|Geometric means for each treatment combination is obtained from the linear mixed effects model Log (parameter) = Intercept + ß*Treatment + Error.|AUC0-t Ratio|2.942|||||2-Sided|90.0|2.439|3.548|||||The ratios of the geometric means (combination/alone) and its 90% CI are obtained by exponentiating the least squares mean difference and its 90% CI of the natural log-transformed data.|Statistical Analysis of Stage 1 AUC0-t Data: Point estimates for the geometric means and their 90% confidence interval (CI) are obtained by exponentiating the least squares mean and the lower and upper bounds of the 90% CI of the natural log-transformed data.|
1683842|NCT01196819|3097233|Other|||||||1|||||||Fisher Exact||||
1683843|NCT01196819|3097234|Other|||||||0.77|||||||Fisher Exact||||
1683844|NCT01196819|3097235|Other|||||||0.76|||||||Fisher Exact||||
1683845|NCT01196819|3097236|Other|||||||1|||||||Fisher Exact||||
1683846|NCT01196819|3097237|Non-Inferiority|Assume the in-stent percent diameter stenosis of both FIREHAWK and XIENCE V are 16 ± 16%, the non-inferiority value is 5%, the level of statistical significance is 0.05 (bilateral test), the power is 85%.||||||0.69|||||||Mixed Models Analysis||||
1683847|NCT01196819|3097238|Non-Inferiority|Non-inferiority margin is 0.13mm, if the two-sided upper 95% confidence bound is <Δ, the Firehawk Stent being tested will be considered non-inferior to the control. This corresponds to a P value <0.05 from a two-sided Student t-test comparing the difference between FirehawkStent and Xience stent to delta.|Mean Difference (Final Values)|0.17||||0.94|2-Sided|95.0|0.0|0.29|||ANCOVA|||H0: Pe - Pc≥ ∆, H1: Pe - Pc < ∆. Pe and Pc are the mean 9-month in-stent late loss for the subject in the Firehawk DES group and the Xience group, respectively. ∆ is the non-inferiority margin. A two-sided upper 95% confidence bound will be calculated for the difference in 9-month in-stent late loss .|
1683848|NCT01196741|3097240|Superiority or Other|||||||0.99|||||||Regression, Cox||||
1683849|NCT01196741|3097242|Superiority or Other|||||||0.0476|||||||Mixed Models Analysis||||
1683850|NCT01196741|3097245|Superiority or Other|||||||0.81|||||||Regression, Cox||||
1683851|NCT01196741|3097246|Superiority or Other||Hazard Ratio (HR)|0.89||||0.57|2-Sided|95.0|0.65|1.23|||Regression, Cox||||
1683852|NCT01196533|3097247|Superiority or Other||||||||||||||||||All data in the outcome measure table is presenting the percentage of error.
1683853|NCT01196117|3097273|Superiority|||||||0.2134|||||||Wilcoxon (Mann-Whitney)||||
1683854|NCT01196117|3097274|Superiority|||||||0.0597|||||||Wilcoxon (Mann-Whitney)||||
1683855|NCT01196117|3097275|Superiority|||||||0.5139|||||||Wilcoxon (Mann-Whitney)||||
1683856|NCT01196117|3097276|Superiority||||||<|0.249|||||||Wilcoxon (Mann-Whitney)||||
1683857|NCT01196117|3097277|Superiority|||||||0.1321|||||||Wilcoxon (Mann-Whitney)||||
1683858|NCT01196117|3097278|Superiority||||||<|0.02|||||||Wilcoxon (Mann-Whitney)||||
1683859|NCT01196117|3097279|Superiority||||||<|0.014|||||||Wilcoxon (Mann-Whitney)||||
1683860|NCT01196117|3097280|Superiority|||||||0.8938|||||||Wilcoxon (Mann-Whitney)||||
1683867|NCT01196078|3097326|Superiority or Other|||||||0.006|||||||ANOVA|||PWB, Baseline versus Endpoint|
1683868|NCT01196078|3097328|Superiority or Other|||||||0.9894|||||||Log Rank|Data were stratified by gender, ECOG status, histology status, and smoking status.|||
1683869|NCT01196078|3097330|Superiority or Other|||||||0.2314|||||||Log Rank|Data were stratified by gender, ECOG status, histology status, and smoking status.|||
1683870|NCT01196078|3097332|Superiority or Other|||||||0.9505|||||||Log Rank||||
1683871|NCT01196078|3097333|Superiority or Other||Difference in Percentages|14.79||||0.1061|2-Sided|95.0|-3.54|31.33||Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, ECOG status, histology status, and smoking status) as explanatory variables.|Regression, Logistic||95% CI for the difference in the disease control rate determined using Hauck-Anderson approach.||
1683872|NCT01196078|3097334|Superiority or Other||Difference in Percentages|13.88||||0.0388|2-Sided|95.0|-0.22|26.19||Between-treatment difference computed using logistic regression with treatment and multiple factors (gender, Eastern Cooperative Oncology Group [ECOG] status, histology status, and smoking status) as explanatory variables.|Regression, Logistic||95% confidence interval (CI) for the difference in tumor response rate determined using Hauck-Anderson approach.||
1683873|NCT01195883|3097386|Superiority||Odds Ratio (OR)|1.33||||0.4|2-Sided|95.0|0.69|2.58|||Chi-squared||||
1683874|NCT01195883|3097387|Superiority||Risk Ratio (RR)|0.89||||0.26|2-Sided|95.0|0.72|1.09|||Chi-squared||||
1683875|NCT01195883|3097388|Superiority||Risk Ratio (RR)|0.95||||0.42|2-Sided|95.0|0.81|1.11|||Chi-squared||||
1683876|NCT01195883|3097389|Superiority||Risk Ratio (RR)|0.9||||0.51|2-Sided|95.0|0.65|1.23|||GEE model||||
1683877|NCT01195675|3097431|Non-Inferiority or Equivalence|Empa vs placebo|Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.69|||2-Sided|90.0|-1.39|0.94|||||Mean difference = Empa minus placebo|Non-inferiority margin: 10ms|
1683878|NCT01195675|3097432|Non-Inferiority or Equivalence|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|1.59|Standard Error of the Mean|1.16|||2-Sided|90.0|-0.35|3.53|||||Mean difference = Empa minus placebo|Non-inferiority margin: 10ms|
1683879|NCT01195675|3097433|Non-Inferiority or Equivalence|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|2.16|Standard Error of the Mean|1.5|||2-Sided|90.0|-0.34|4.67|||||Mean difference = Empa minus placebo|Non-inferiority margin: 10ms|
1683880|NCT01195675|3097434|Superiority or Other||Mean Difference (Final Values)|12.42|Standard Error of the Mean|1.01|<|0.0001|2-Sided|90.0|10.73|14.11|||ANCOVA|Based on ANCOVA with terms for treatment, period, treatment sequence, baseline and subject within sequence.|Non-confirmatory testing. Mean difference = Moxifloxacin minus placebo.||
1683881|NCT01195675|3097435|Non-Inferiority or Equivalence|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.65|||2-Sided|90.0|-1.23|0.93|||||Mean difference = Empa minus placebo|Non-inferiority margin: 10ms|
1683882|NCT01195675|3097436|Non-Inferiority or Equivalence|Empa vs placebo. Non-confirmatory testing.|Mean Difference (Final Values)|0.66|Standard Error of the Mean|0.62|||2-Sided|90.0|-0.38|1.71|||||Mean difference = Empa minus placebo|Non-inferiority margin: 10ms|
1683883|NCT01195675|3097437|Non-Inferiority or Equivalence|Empa vs placebo|Mean Difference (Final Values)|0.59|Standard Error of the Mean|0.76|||2-Sided|90.0|-0.69|1.87|||||Mean difference = Empa minus placebo|Non-inferiority margin: 10ms|
1683884|NCT01195662|3097443|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.0858|||2-Sided|95.0|-0.57|-0.23||||||Longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by week interaction, and randomization strata and continuous fixed covariates of baseline serum uric acid value and baseline seated serum uric acid value by week interaction. By applying sequential testing procedure at alpha=0.05, no testing was performed since the prior secondary endpoint was not significant.|
1683885|NCT01195662|3097444|Superiority or Other||Mean Difference (Final Values)|-1.99|Standard Error of the Mean|0.8635|||2-Sided|95.0|-3.68|-0.29||||||ANCOVA model with treatment group as an effect and baseline value and randomization strata as a covariate. A hierarchical closed testing procedure was implemented to control the family-wise type I error rate related to the co-primary and secondary endpoints at the 2-sided 0.05 level. Statistical testing of this endpoint was not performed since the prior secondary endpoint was not statistically significant.|
1683886|NCT01195662|3097445|Superiority or Other||Mean Difference (Final Values)|-0.97|Standard Error of the Mean|0.69||0.1619|2-Sided|95.0|-2.32|0.39||Endpoint tested following a sequential testing procedure at alpha=0.05.|Longitudinal repeated measures|||Longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by week interaction, and randomization strata and continuous fixed covariates of baseline seated diastolic BP value and baseline seated diastolic BP value by week interaction.|
1683887|NCT01195662|3097446|Superiority or Other||Mean Difference (Final Values)|-4.45|Standard Error of the Mean|1.368||0.0012|2-Sided|95.0|-7.14|-1.76||Endpoint tested following a sequential testing procedure at alpha=0.05.|ANCOVA|||ANCOVA model with treatment group as an effect and baseline value and randomization strata as a covariate was used. By applying sequential testing procedure, the testing was performed since the prior endpoint was significant.|
1683888|NCT01195662|3097447|Superiority or Other||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.0773|<|0.0001|2-Sided|95.0|-0.76|-0.46|||Longitudinal repeated measures|Endpoint was tested at alpha=0.05. Hierarchical closed testing procedure was used.||A longitudinal repeated measures analysis used, with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata, continuous fixed covariates of baseline HbA1c value and baseline HbA1c value-by-week interaction. Only data up to Week 12 included. All data used in the model even if participants discontinued prior to Week 12. A heirarchical closed testing procedure (sequential) was used and testing performed since first primary endpoint was significant.|
1683943|NCT01195272|3097499|Superiority or Other|||||||0.288|||||||t-test, 2 sided|||4 hrs: Visit 3 versus Visit 2|
1683944|NCT01195272|3097500|Superiority or Other|||||||0.315|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 5|
1683945|NCT01195272|3097500|Superiority or Other|||||||0.285|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 3|
1683946|NCT01195272|3097500|Superiority or Other|||||||0.047|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 2|
1683889|NCT01195662|3097448|Superiority or Other||Mean Difference (Final Values)|-4.28|Standard Error of the Mean|1.1485||0.0002|2-Sided|95.0|-6.54|-2.02||Endpoint was tested at alpha=0.05. Hierarchical closed testing procedure used.|Longitudinal repeated measures|Data from all weeks during the double-blind treatment period were included.||Longitudinal repeated measures analysis using 'direct likelihood', with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata, as well as continuous fixed covariates of baseline SBP value and baseline SBP value-by-week interaction. Unstructured matrix for within-subject error variance-covariance used. 80% power to detect a difference of 4 mmHg in mean change from baseline, 75% power to meet both co-primary endpoints with overall Type I error.|
1683890|NCT01195272|3097489|Superiority or Other|||||||0.461|||||||ANOVA|||Visit 8 versus Visit 5|
1683891|NCT01195272|3097489|Superiority or Other|||||||0.082|||||||ANOVA|||Visit 8 versus Visit 3|
1683892|NCT01195272|3097489|Superiority or Other|||||||0.135|||||||ANOVA|||Visit 8 versus Visit 2|
1683893|NCT01195272|3097489|Superiority or Other|||||||0.07|||||||ANOVA|||Visit 5 versus Visit 3|
1683894|NCT01195272|3097489|Superiority or Other|||||||0.122|||||||ANOVA|||Visit 5 versus Visit 2|
1683895|NCT01195272|3097489|Superiority or Other|||||||0.496|||||||ANOVA|||Visit 3 versus Visit 2|
1683896|NCT01195272|3097490|Superiority or Other|||||||0.375|||||||ANOVA|||Visit 8 versus Visit 5|
1683897|NCT01195272|3097490|Superiority or Other|||||||0.396|||||||ANOVA|||Visit 8 versus Visit 3|
1683898|NCT01195272|3097490|Superiority or Other|||||||0.243|||||||ANOVA|||Visit 8 versus Visit 2|
1683899|NCT01195272|3097490|Superiority or Other|||||||0.471|||||||ANOVA|||Visit 5 versus Visit 3|
1683900|NCT01195272|3097490|Superiority or Other|||||||0.165|||||||ANOVA|||Visit 5 versus Visit 2|
1683901|NCT01195272|3097490|Superiority or Other|||||||0.169|||||||ANOVA|||Visit 3 versus Visit 2|
1683902|NCT01195272|3097491|Superiority or Other|||||||0.047|||||||ANOVA|||Visit 8 versus Visit 5|
1683903|NCT01195272|3097491|Superiority or Other|||||||0.061|||||||ANOVA|||Visit 8 versus Visit 3|
1683904|NCT01195272|3097491|Superiority or Other|||||||0.149|||||||ANOVA|||Visit 8 versus Visit 2|
1683905|NCT01195272|3097491|Superiority or Other|||||||0.06|||||||ANOVA|||Visit 5 versus Visit 3|
1683906|NCT01195272|3097491|Superiority or Other|||||||0.25|||||||ANOVA|||Visit 5 versus Visit 2|
1683907|NCT01195272|3097491|Superiority or Other|||||||0.467|||||||ANOVA|||Visit 3 versus Visit 2|
1683908|NCT01195272|3097492|Superiority or Other|||||||0.138|||||||ANOVA|||Visit 8 versus Visit 5|
1683909|NCT01195272|3097492|Superiority or Other|||||||0.398|||||||ANOVA|||Visit 8 versus Visit 3|
1683910|NCT01195272|3097492|Superiority or Other|||||||0.145|||||||ANOVA|||Visit 8 versus Visit 2|
1683911|NCT01195272|3097492|Superiority or Other|||||||0.092|||||||ANOVA|||Visit 5 versus Visit 3|
1683912|NCT01195272|3097492|Superiority or Other|||||||0.083|||||||ANOVA|||Visit 5 versus Visit 2|
1683913|NCT01195272|3097492|Superiority or Other|||||||0.313|||||||ANOVA|||Visit 3 versus Visit 2|
1683914|NCT01195272|3097493|Superiority or Other|||||||0.44|||||||ANOVA|||Visit 5 versus Visit 3|
1683915|NCT01195272|3097493|Superiority or Other|||||||0.43|||||||ANOVA|||Visit 5 versus Visit 2|
1683916|NCT01195272|3097493|Superiority or Other|||||||0.48|||||||ANOVA|||Visit 3 versus Visit 2|
1683917|NCT01195272|3097494|Superiority or Other|||||||0.18|||||||ANOVA|||Visit 5 versus Visit 3|
1683918|NCT01195272|3097494|Superiority or Other|||||||0.01|||||||ANOVA|||Visit 5 versus Visit 2|
1683919|NCT01195272|3097494|Superiority or Other|||||||0.05|||||||ANOVA|||Visit 3 versus Visit 2|
1683920|NCT01195272|3097495|Superiority or Other|||||||0.24|||||||ANOVA|||Visit 5 versus Visit 3|
1683921|NCT01195272|3097495|Superiority or Other|||||||0.46|||||||ANOVA|||Visit 5 versus Visit 2|
1683922|NCT01195272|3097495|Superiority or Other|||||||0.22|||||||ANOVA|||Visit 3 versus Visit 2|
1683923|NCT01195272|3097496|Superiority or Other|||||||0.23|||||||ANOVA|||Visit 5 versus Visit 3|
1683924|NCT01195272|3097496|Superiority or Other|||||||0.44|||||||ANOVA|||Visit 5 versus Visit 2|
1683925|NCT01195272|3097496|Superiority or Other|||||||0.22|||||||ANOVA|||Visit 3 versus Visit 2|
1683926|NCT01195272|3097497|Superiority or Other|||||||0.34|||||||ANOVA|||Visit 5 versus Visit 3|
1683927|NCT01195272|3097497|Superiority or Other|||||||0.3|||||||ANOVA|||Visit 5 versus Visit 2|
1683928|NCT01195272|3097497|Superiority or Other|||||||0.48|||||||ANOVA|||Visit 3 versus Visit 2|
1683929|NCT01195272|3097498|Superiority or Other|||||||0.18|||||||ANOVA|||Visit 5 versus Visit 3|
1683930|NCT01195272|3097498|Superiority or Other|||||||0.08|||||||ANOVA|||Visit 5 versus Visit 3|
1683931|NCT01195272|3097498|Superiority or Other|||||||0.39|||||||ANOVA|||Visit 3 versus Visit 2|
1683932|NCT01195272|3097499|Superiority or Other|||||||0.345|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 5|
1683933|NCT01195272|3097499|Superiority or Other|||||||0.444|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 3|
1683934|NCT01195272|3097499|Superiority or Other|||||||0.422|||||||t-test, 2 sided|||20 hrs: Visit 8 versus Visit 2|
1683935|NCT01195272|3097499|Superiority or Other|||||||0.378|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 3|
1683936|NCT01195272|3097499|Superiority or Other|||||||0.266|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 2|
1683937|NCT01195272|3097499|Superiority or Other|||||||0.354|||||||t-test, 2 sided|||20 hrs: Visit 3 versus Visit 2|
1683938|NCT01195272|3097499|Superiority or Other|||||||0.052|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 5|
1683939|NCT01195272|3097499|Superiority or Other|||||||0.137|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 3|
1683940|NCT01195272|3097499|Superiority or Other|||||||0.317|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 2|
1683941|NCT01195272|3097499|Superiority or Other|||||||0.4|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 3|
1683942|NCT01195272|3097499|Superiority or Other|||||||0.318|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 2|
1683947|NCT01195272|3097500|Superiority or Other|||||||0.484|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 3|
1683948|NCT01195272|3097500|Superiority or Other|||||||0.202|||||||t-test, 2 sided|||20 hrs: Visit 5 versus Visit 2|
1683949|NCT01195272|3097500|Superiority or Other|||||||0.131|||||||t-test, 2 sided|||20 hrs: Visit 3 versus Visit 2|
1683950|NCT01195272|3097500|Superiority or Other|||||||0.031|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 5|
1683951|NCT01195272|3097500|Superiority or Other|||||||0.061|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 3|
1683952|NCT01195272|3097500|Superiority or Other|||||||0.12|||||||t-test, 2 sided|||4 hrs: Visit 8 versus Visit 2|
1683953|NCT01195272|3097500|Superiority or Other|||||||0.335|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 3|
1683954|NCT01195272|3097500|Superiority or Other|||||||0.415|||||||t-test, 2 sided|||4 hrs: Visit 5 versus Visit 2|
1683955|NCT01195272|3097500|Superiority or Other|||||||0.308|||||||t-test, 2 sided|||4 hrs: Visit 3 versus Visit 2|
1683956|NCT01195090|3097513|Non-Inferiority or Equivalence|Chi-square test|Chi-Square|0.0034||||0.954||||||Chi-square test|Chi-squared|||Chi-square test for percentages of patient achieving an A1C <7%|
1683957|NCT01195090|3097529|Superiority or Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.16||0.165|2-Sided|95.0|-0.58|0.08||The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor ‘treatment’ and baseline A1C as covariate.|ANCOVA|||The change from baseline in A1C were determined using an analysis of co-variance (ANCOVA) model with the factor ‘treatment’ and baseline A1C as covariate.|
1683958|NCT01194999|3097535|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: No significant difference from baseline to final follow-up.|
1683959|NCT01194973|3097536|Superiority or Other||LS mean change from baseline|102.49|||<|0.0001|2-Sided|95.0|68.15|136.82|||ANOVA||||
1683960|NCT01194973|3097542|Superiority or Other||LS mean change from baseline|117.68|||<|0.0001|2-Sided|95.0|92.77|142.59|||ANOVA||||
1683961|NCT01194830|3097561|Superiority or Other||Least Squares Mean Difference|-1.97|Standard Error of the Mean|24.45||0.9368||95.0|-53.8|49.86|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline 2-hour PPG, and number of other Oral Antidiabetic Drugs|||
1683962|NCT01194830|3097562|Superiority or Other||Least Squares Mean Difference|-12.0|Standard Error of the Mean|7.2||0.0972||95.0|-26.1|2.2|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and number of other Oral Antidiabetic Drugs|||
1683963|NCT01194830|3097563|Superiority or Other||Odds Ratio (OR)|2.951||||0.0003|2-Sided|95.0|1.651|5.274|||Regression, Logistic||||
1683964|NCT01194830|3097564|Superiority or Other||Odds Ratio (OR)|5.433||||0.0352|2-Sided|95.0|1.124|26.26|||Regression, Logistic||||
1683965|NCT01194830|3097565|Superiority or Other||Odds Ratio (OR)|4.063||||0.001|2-Sided|95.0|1.764|9.358|||Regression, Logistic||||
1683966|NCT01194830|3097566|Superiority or Other||Least Squares Mean Difference|-0.55|Standard Error of the Mean|0.15||0.0003||95.0|-0.85|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs|||
1683967|NCT01194830|3097567|Superiority or Other||Least Squares Mean Difference|-0.55|Standard Error of the Mean|0.15||0.0002||95.0|-0.84|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs|||
1683968|NCT01194830|3097568|Superiority or Other||Least Squares Mean Difference|-0.42|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.62|-0.22|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs|||
1683969|NCT01194830|3097569|Superiority or Other||Least Squares Mean Difference|-0.58|Standard Error of the Mean|0.16||0.0005||95.0|-0.91|-0.26|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and number of other Oral Antidiabetic Drugs|||
1683970|NCT01194804|3097574|Other||||||<|0.001|||||||Sign test||||
1683971|NCT01194570|3097585|Superiority or Other (legacy)||Difference in Adjusted Means|0.377|Standard Error of the Mean|0.725||0.6034|2-Sided|95.0|-1.048|1.802|||MMRM||Difference in adjusted mean was calculated as Ocrelizumab SF-36 Physical Component Summary Score - Placebo SF-36 Physical Component Summary Score.|Estimates are from analysis based on MMRM using unstructured covariance matrix: Change = Baseline PCS Score + Geographical Region (US vs. ROW) + Age (<=45, > 45 years) + Week + Treatment + Treatment*Week (repeated values over Week) + Baseline PCS Score*Week.|
1683972|NCT01194570|3097586|Superiority or Other (legacy)||Relative Reduction (%)|17.475||||0.0206|2-Sided|95.0|3.206|29.251|||MMRM||Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.|Estimates are from analysis based on MMRM using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Age (<=45, > 45 years) + Week + Treatment + Treatment*Week (repeated values over Week) + Brain Volume at Week 24*Week. Relative reduction was calculated as – Relative change = - (OCR response-Placebo response)/Placebo response*100%. The 95% CI for relative reduction was obtained using Bootstrap method.|
1683973|NCT01194570|3097587|Superiority or Other (legacy)||Ratio of Adjusted Geometric Means|0.9|||<|0.0001|2-Sided|95.0|0.876|0.924||P-value is from ranked ANCOVA on Percent Change from BL adjusting for rank of BL T2 lesion volume, Geographical Region (US vs ROW) and Age (<=45, > 45 years); missing observations imputed with LOCF.|Ranked ANCOVA|||Estimates (back-transformed) are based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-BL/BL) = log(BL T2 lesion volume) + Geographical Region (US vs. ROW) + Age (<=45, > 45 years) + Week + Treatment + Treatment*Week (repeated values over Week) + log (BL T2 lesion volume)*Week.|
1683998|NCT01193660|3097705|Superiority or Other||Wilks' Lambda (group*visit effect)|0.56|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.|
1683974|NCT01194570|3097588|Superiority or Other (legacy)||Relative Reduction (%)|29.337||||0.0404|2-Sided|95.0|-1.618|51.456||P-value from a ranked ANCOVA on Percent Change from BL adjusting for rank of BL 25-Foot Timed Walk (25-FTW), Geographical Region (US vs ROW) and Age (<=45, > 45 years); missing observations imputed with LOCF.|Ranked ANCOVA||Relative reduction was calculated as -Relative change = - (Ocrelizumab response-Placebo response)/Placebo response*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.|Estimates (back-transformed) based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: log(Post-baseline(BL)/BL) = log(BL 25-FTW) + Geographical Region (US vs. ROW) + Age (<=45, > 45 years) + Week + Treatment + Treatment*Week (repeated values over Week) + log (BL 25-FTW)*Week. Relative reduction was calculated as -Relative change = -(OCR response-Placebo response)/Placebo response*100%. The 95% CI for relative reduction was obtained using the Bootstrap method.|
1683975|NCT01194440|3097602|Superiority or Other||||||<|0.001|||||||Bonferonni|Adjusting for multiple comparisons in the analyses, a Bonferonni-corrected p-value of 0.05/5 = 0.01 to represent statistical significance was used.||The primary hypothesis of the study is that administration of zoledronic acid with letrozole would result in a significant decline in the percentage of women experiencing AIMSS compared to letrozole treatment alone (historical control).|
1683976|NCT01194258|3097630|Non-Inferiority or Equivalence|Non-inferiority margin was set at 0.40.|LS Mean difference|-0.04|Standard Error of the Mean|0.041||0.3876|2-Sided|95.0|-0.12|0.05|||Mixed Models Analysis|||Approximately 110 participants were planned to be enrolled to allow approximately 88 participants to complete both treatment periods. Assuming a dropout rate of ≤20%, an intra-participant correlation of 0.80, a standard deviation of 1.2, and a true difference of 0, the study would have >90% power to show that either Lispro-PH20 or Aspart-PH20 (each tested separately) was non-inferior to insulin lispro alone with respect to the change from baseline in A1C at the end of each treatment period.|
1683977|NCT01194245|3097633|Non-Inferiority or Equivalence|Non-inferiority would be supported if the upper limit of the two-sided 95% confidence interval for the difference between Analog-PH20 and the comparator (insulin lispro) did not exceed 0.40.|LS Means Difference|0.05||||0.2878|2-Sided|95.0|-0.05|0.15|||Mixed Models Analysis|||Approximately 110 participants were to be enrolled, allowing approximately 88 participants to complete both treatment periods (44 for each investigational drug). Assuming a dropout rate of no more than 20%, intra-participant correlation of 0.80, standard deviation of 1.2, and a true difference of 0, the study would have a greater than 90% power to show that Analog-PH20 was non-inferior to insulin lispro alone with respect to the change from baseline in A1C at the end of each treatment period.|
1683978|NCT01194219|3097641|Superiority or Other (legacy)||Hazard Ratio (HR)|2.649|||<|0.0001|2-Sided|95.0|1.768|3.969|||Log Rank||||
1683979|NCT01194219|3097642|Superiority or Other (legacy)||Risk Difference (RD)|16.7|||<|0.0001|2-Sided|95.0|12.8|20.7|||Chi-squared||||
1683980|NCT01194219|3097643|Superiority or Other (legacy)||LS Mean Difference|3.08|||<|0.0001|2-Sided|95.0|1.81|4.35|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.|||
1683981|NCT01194219|3097644|Superiority or Other (legacy)||Difference in LS Mean|-4.5|||<|0.0001|2-Sided|95.0|-5.4|-3.6|||ANOVA||Based on an analysis of covariance model for the change from baseline at Week 16, with treatment group as a factor, the baseline value, and the treatment by baseline interaction term as covariates.||
1683982|NCT01194219|3097645|Superiority or Other (legacy)||Difference in LS Mean|-24.2|||<|0.0001|2-Sided|95.0|-28.7|-19.8|||ANOVA|Based on an analysis of variance model for the change from baseline at Week 16, with treatment group as a factor (an ANOVA model).|||
1683983|NCT01194219|3097646|Superiority or Other (legacy)||Risk Difference (RD)|41.7|||<|0.0001|2-Sided|95.0|35.7|47.7|||Chi-squared||||
1683984|NCT01194219|3097647|Superiority or Other (legacy)||Difference in LS Mean|-35.3|||<|0.0001|2-Sided|95.0|-39.9|-30.6|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.|||
1683985|NCT01194219|3097648|Superiority or Other (legacy)||Difference in LS Mean|-40.78|||<|0.0001|2-Sided|95.0|-46.34|-35.21|||ANCOVA|The model included treatment group as a factor and the baseline value as a covariate. The estimation and p-value were adjusted by the covariate.|||
1683986|NCT01194219|3097649|Superiority or Other (legacy)||Risk Difference (RD)|17.8|||<|0.0001|2-Sided|95.0|13.7|21.9|||Chi-squared||||
1683987|NCT01194219|3097650|Superiority or Other (legacy)||Risk Difference (RD)|27.8|||<|0.0001|2-Sided|95.0|23.1|32.5|||Chi-squared||||
1683988|NCT01194154|3097656|Superiority or Other||treatment effect|2.24||||0.709|2-Sided|95.0|-0.54|5.01|||Wilcoxon (Mann-Whitney)||ANCOVA model with adjustment for baseline eGFR was used to obtain an estimate of the treatment difference.||
1683989|NCT01194154|3097657|Superiority or Other||treatment effect|2.21||||0.657|2-Sided|95.0|-0.35|4.78|||Wilcoxon (Mann-Whitney)||An analysis of covariance (ANCOVA) model with adjustment for baseline eGFR was used to obtain an estimate of the treatment difference.||
1683990|NCT01194089|3097658|Superiority or Other|||||||0.381|||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at discharge.|
1683991|NCT01194089|3097658|Superiority or Other|||||||0.809|||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at 60 minutes.|
1683992|NCT01194089|3097658|Superiority or Other|||||||0.492|||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score at 30 minutes.|
1683993|NCT01194089|3097658|Superiority or Other|||||||0.354|||||||Wilcoxon (Mann-Whitney)|||The arms were compared for numeric pain score on admission.|
1683994|NCT01194089|3097659|Superiority or Other|||||||0.002|||||||Chi-squared|||Comparison between the arms for antiemetic medication use in the PACU.|
1683995|NCT01194089|3097660|Superiority or Other|||||||0.752|||||||Wilcoxon (Mann-Whitney)|||Comparison between the arms for the first 24 hours postoperatively, using a one tailed P value.|
1683996|NCT01194089|3097660|Superiority or Other|||||||0.828|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for the postoperative opioid use during the postanesthesia care unit (PACU) stay, using a one tailed P value.|
1683997|NCT01193660|3097704|Superiority or Other||||||<|0.05|||||||Fisher Exact|We compared the ratio of participants with a certain adverse event (AE) and without the AE between three groups using Fisher Exact test.|||
1683999|NCT01193660|3097706|Superiority or Other||Wilks' Lambda (group*visit effect)|0.996|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.|
1684000|NCT01193660|3097707|Superiority or Other||Wilks' Lambda (group*visit effect)|1.279|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.|
1684001|NCT01193660|3097708|Superiority or Other||interaction of group and visit|0.9|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.|
1684002|NCT01193660|3097710|Superiority or Other|||||||0.05||||||The baseline and post-therapy data of each group were compared using paired t-test statistics.|t-test, 2 sided|Voxels with an uncorrected p-value of <0.05 were considered significant, and an extent threshold Ke of 100 voxels was set by SPM implanted in Matlab.||In our analysis, the null hypothesis is that the effects of three experimental groups are same each other, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) has much higher than that of either Erythropoietin + Rehabilitation Group or Rehabilitation Group. This study is a pilot study and therefore, power calculation was not applicable in our study. The sample size of each group is more than 30.|
1684003|NCT01193660|3097712|Superiority or Other||Wilks' Lambda (group*visit effect)|2.7|||<|0.05||95.0|||||Repeated Measure ANOVA|||The null hypothesis is that in terms of K-BSID-II MOTOR Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.|
1684004|NCT01193660|3097713|Superiority or Other||Wilks' Lambda (group*visit effect)|3.94|||<|0.05||95.0|||||Repeated Measure ANOVA|||The null hypothesis is that in terms of K-BSID-II MENTAL Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.|
1684005|NCT01193660|3097714|Superiority or Other||Wilks' Lambda (group*visit effect)|2.59|||<|0.05||95.0|||||Repeated Measure ANOVA|||In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.|
1684006|NCT01193608|3097722|Superiority or Other||Mean change|1.23||||0.603|2-Sided|80.0|-1.89|4.35|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group|
1684007|NCT01193608|3097724|Superiority or Other||Mean change|-15.26||||0.6|2-Sided|80.0|-53.54|23.02|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group|
1684008|NCT01193608|3097726|Superiority or Other||Mean change|48.85||||0.297|2-Sided|80.0|-11.79|109.48|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group|
1684009|NCT01193608|3097728|Superiority or Other||Mean change|113.53||||0.599|2-Sided|80.0|-170.3|397.35|||t-test, 2 sided||One sample paired t-test|Change from baseline, within group|
1684010|NCT01193348|3097781|Superiority or Other||LS mean change from baseline|165.43|||<|0.0001|2-Sided|95.0|98.43|232.43|||ANOVA||||
1684011|NCT01193348|3097782|Superiority or Other||Percent of eGFR Improvement|86.4|||||2-Sided|95.0|65.1|97.1|||||||
1684012|NCT01193348|3097783|Superiority or Other||Percent of Platelet Count Normalization|95.5|||||2-Sided|95.0|77.2|99.9|||||||
1684013|NCT01193348|3097784|Superiority or Other||Percent of Complete Hematologic Response|90.9|||||2-Sided|95.0|70.8|98.9|||||||
1684014|NCT01193348|3097785|Superiority or Other||Percent of Complete TMA Response|68.2|||||2-Sided|95.0|45.1|86.1|||||||
1684015|NCT01193348|3097786|Superiority or Other||LS mean change from baseline|204.96|||<|0.0001|2-Sided|95.0|164.44|245.49|||ANOVA||||
1684016|NCT01193348|3097787|Superiority or Other||Percent of eGFR Improvement|86.4|||||2-Sided|95.0|65.1|97.1|||||||
1684017|NCT01193348|3097788|Superiority or Other||Percent of Platelet Count Normalization|95.0|||||2-Sided|95.0|77.2|99.9|||||||
1684018|NCT01193348|3097789|Superiority or Other||Percent of Complete Hematologic Response|81.8|||||2-Sided|95.0|59.7|94.8|||||||
1684019|NCT01193348|3097790|Superiority or Other||Percent of Complete TMA Response|63.6|||||2-Sided|95.0|40.7|82.8|||||||
1684020|NCT01193335|3097791|Superiority or Other||Percent difference|-21.6|||||2-Sided|95.0|-37.7|-4.6||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684021|NCT01193335|3097791|Superiority or Other||Percent Difference|-11.3|||||2-Sided|95.0|-26.4|4.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684022|NCT01193335|3097791|Superiority or Other||Percent Difference|-20.4|||||2-Sided|95.0|-36.8|-3.0||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684023|NCT01193335|3097791|Superiority or Other||Percent Difference|-14.4|||||2-Sided|95.0|-26.7|-2.4||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684024|NCT01193335|3097791|Superiority or Other||Percent Difference|-5.1|||||2-Sided|95.0|-22.0|12.0||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684025|NCT01193335|3097791|Superiority or Other||Percent Difference|5.6|||||2-Sided|95.0|-2.7|15.2||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684026|NCT01193335|3097791|Superiority or Other||Percent Difference|-21.1|||||2-Sided|95.0|-37.8|-3.2||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684027|NCT01193335|3097791|Superiority or Other||Percent Difference|-4.3|||||2-Sided|95.0|-20.6|12.1||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684028|NCT01193335|3097791|Superiority or Other||Percent Difference|-17.9|||||2-Sided|95.0|-34.6|-0.3||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684029|NCT01193335|3097791|Superiority or Other||Percent Difference|-2.8|||||2-Sided|95.0|-19.1|13.3||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684030|NCT01193335|3097791|Superiority or Other||Percent Difference|7.3|||||2-Sided|95.0|-12.0|26.2||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684031|NCT01193335|3097791|Superiority or Other||Percent Difference|0.3|||||2-Sided|95.0|-18.5|19.0||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684032|NCT01193335|3097791|Superiority or Other||Percent Difference|-7.9|||||2-Sided|95.0|-25.2|9.9||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684033|NCT01193335|3097792|Superiority or Other||Percent Difference|-18.5|||||2-Sided|95.0|-33.7|-2.8||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684034|NCT01193335|3097792|Superiority or Other||Percent Difference|2.8|||||2-Sided|95.0|-7.1|13.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684035|NCT01193335|3097792|Superiority or Other||Percent Difference|-18.6|||||2-Sided|95.0|-33.3|-3.0||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684036|NCT01193335|3097792|Superiority or Other||Percent Difference|-10.6|||||2-Sided|95.0|-25.3|4.5||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684037|NCT01193335|3097792|Superiority or Other||Percent Difference|-1.2|||||2-Sided|95.0|-17.5|15.1||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684038|NCT01193335|3097792|Superiority or Other||Percent Difference|-0.3|||||2-Sided|95.0|-10.9|10.3||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684039|NCT01193335|3097792|Superiority or Other||Percent Difference|-28.2|||||2-Sided|95.0|-43.9|-11.0||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684040|NCT01193335|3097792|Superiority or Other||Percent Difference|-11.9|||||2-Sided|95.0|-27.4|3.4||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684041|NCT01193335|3097792|Superiority or Other||Percent Difference|-23.0|||||2-Sided|95.0|-40.0|-4.9||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684042|NCT01193335|3097792|Superiority or Other||Percent Difference|-4.3|||||2-Sided|95.0|-17.0|8.4||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684043|NCT01193335|3097792|Superiority or Other||Percent Difference|-10.7|||||2-Sided|95.0|-27.6|6.0||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684044|NCT01193335|3097792|Superiority or Other||Percent Difference|-5.9|||||2-Sided|95.0|-23.6|11.8||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684045|NCT01193335|3097792|Superiority or Other||Percent Difference|-7.5|||||2-Sided|95.0|-24.5|9.9||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684046|NCT01193335|3097793|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-4.48|4.55||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684047|NCT01193335|3097793|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-4.48|4.55||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684048|NCT01193335|3097793|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-4.73|5.04||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684049|NCT01193335|3097793|Superiority or Other||Percent Difference|-1.34|||||2-Sided|95.0|-8.36|5.14||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684050|NCT01193335|3097793|Superiority or Other||Percent Difference|1.27|||||2-Sided|95.0|-3.37|6.85||||||Serotype 3: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684051|NCT01193335|3097793|Superiority or Other||Percent Difference|-6.48|||||2-Sided|95.0|-16.37|2.75||||||Serotype 1: CI Parameter was percent difference between the groups. Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684052|NCT01193335|3097793|Superiority or Other||Percent Difference|0.05|||||2-Sided|95.0|-6.74|7.04||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684053|NCT01193335|3097793|Superiority or Other||Percent Difference|-6.64|||||2-Sided|95.0|-17.93|3.56||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684054|NCT01193335|3097793|Superiority or Other||Percent Difference|-1.61|||||2-Sided|95.0|-8.66|4.25||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684055|NCT01193335|3097793|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-5.94|5.94||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684056|NCT01193335|3097793|Superiority or Other||Percent Difference|-1.55|||||2-Sided|95.0|-10.87|7.44||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684057|NCT01193335|3097793|Superiority or Other||Percent Difference|0.08|||||2-Sided|95.0|-6.81|7.37||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684058|NCT01193335|3097793|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-5.59|5.89||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684059|NCT01193335|3097794|Superiority or Other||Percent Difference|-3.14|||||2-Sided|95.0|-17.51|11.13||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684060|NCT01193335|3097794|Superiority or Other||Percent Difference|5.25|||||2-Sided|95.0|-8.5|19.06||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684061|NCT01193335|3097794|Superiority or Other||Percent Difference|-20.19|||||2-Sided|95.0|-35.45|-3.95||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684062|NCT01193335|3097794|Superiority or Other||Percent Difference|0.51|||||2-Sided|95.0|-8.82|10.08||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684063|NCT01193335|3097794|Superiority or Other||Percent Difference|-7.38|||||2-Sided|95.0|-22.86|8.29||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684064|NCT01193335|3097794|Superiority or Other||Percent Difference|8.09|||||2-Sided|95.0|-0.52|17.81||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684065|NCT01193335|3097794|Superiority or Other||Percent Difference|-13.37|||||2-Sided|95.0|-29.57|3.31||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684066|NCT01193335|3097794|Superiority or Other||Percent Difference|7.11|||||2-Sided|95.0|-1.52|17.65||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684067|NCT01193335|3097794|Superiority or Other||Percent Difference|-10.73|||||2-Sided|95.0|-29.01|8.11||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684068|NCT01193335|3097794|Superiority or Other||Percent Difference|-7.88|||||2-Sided|95.0|-20.28|3.35||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684069|NCT01193335|3097794|Superiority or Other||Percent Difference|6.53|||||2-Sided|95.0|-7.16|21.16||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684070|NCT01193335|3097794|Superiority or Other||Percent Difference|-5.39|||||2-Sided|95.0|-21.03|10.4||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684071|NCT01193335|3097794|Superiority or Other||Percent Difference|-9.08|||||2-Sided|95.0|-25.11|7.49||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684072|NCT01193335|3097795|Superiority or Other||Percent Difference|-1.09|||||2-Sided|95.0|-5.96|3.18||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684073|NCT01193335|3097795|Superiority or Other||Percent Difference|-2.15|||||2-Sided|95.0|-7.55|2.1||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684074|NCT01193335|3097795|Superiority or Other||Percent Difference|2.27|||||2-Sided|95.0|-1.96|7.97||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684075|NCT01193335|3097795|Superiority or Other||Percent Difference|-16.06|||||2-Sided|95.0|-29.15|-2.6||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684076|NCT01193335|3097795|Superiority or Other||Percent Difference|4.65|||||2-Sided|95.0|0.04|11.48||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684077|NCT01193335|3097795|Superiority or Other||Perecent Difference|-10.82|||||2-Sided|95.0|-25.51|4.34||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684078|NCT01193335|3097795|Superiority or Other||Percent Difference|1.52|||||2-Sided|95.0|-6.73|9.94||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684079|NCT01193335|3097795|Superiority or Other||Percent Difference|3.45|||||2-Sided|95.0|-3.32|11.91||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684080|NCT01193335|3097795|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-6.57|5.88||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684081|NCT01193335|3097795|Superiority or Other||Percent Difference|3.03|||||2-Sided|95.0|-3.68|10.57||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684082|NCT01193335|3097795|Superiority or Other||Percent Difference|-6.85|||||2-Sided|95.0|-24.28|10.67||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684083|NCT01193335|3097795|Superiority or Other||Percent Difference|-4.89|||||2-Sided|95.0|-16.87|5.39||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684084|NCT01193335|3097795|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-6.33|5.99||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang using the standardized test statistics and gamma=0.000001.|
1684085|NCT01193335|3097796|Superiority or Other||GMT Ratio|0.5|||||2-Sided|95.0|0.22|0.91||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684086|NCT01193335|3097796|Superiority or Other||GMT Ratio|0.6|||||2-Sided|95.0|0.27|1.48||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684087|NCT01193335|3097796|Superiority or Other||GMT Ratio|0.4|||||2-Sided|95.0|0.16|1.03||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684088|NCT01193335|3097796|Superiority or Other||GMT Ratio|0.7|||||2-Sided|95.0|0.49|0.92||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684089|NCT01193335|3097796|Superiority or Other||GMT Ratio|0.7|||||2-Sided|95.0|0.41|1.14||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684090|NCT01193335|3097796|Superiority or Other||GMT Ratio|1.1|||||2-Sided|95.0|0.96|1.31||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684091|NCT01193335|3097796|Superiority or Other||GMT Ratio|0.4|||||2-Sided|95.0|0.17|1.15||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684092|NCT01193335|3097796|Superiority or Other||GMT Ratio|0.6|||||2-Sided|95.0|0.27|1.53||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684093|NCT01193335|3097796|Superiority or Other||GMT Ratio|0.5|||||2-Sided|95.0|0.18|1.21||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684094|NCT01193335|3097796|Superiority or Other||GMT Ratio|0.9|||||2-Sided|95.0|0.38|2.07||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684095|NCT01193335|3097796|Superiority or Other||GMT Ratio|1.7|||||2-Sided|95.0|0.57|5.36||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684096|NCT01193335|3097796|Superiority or Other||GMT Ratio|1.1|||||2-Sided|95.0|0.37|3.07||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684097|NCT01193335|3097796|Superiority or Other||GMT Ratio|0.9|||||2-Sided|95.0|0.33|2.37||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684098|NCT01193335|3097797|Superiority or Other||GMT Ratio|0.5|||||2-Sided|95.0|0.27|0.97||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684099|NCT01193335|3097797|Superiority or Other||GMT Ratio|1.1|||||2-Sided|95.0|0.64|1.97||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684100|NCT01193335|3097797|Superiority or Other||GMT Ratio|0.4|||||2-Sided|95.0|0.17|0.86||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684101|NCT01193335|3097797|Superiority or Other||GMT Ratio|0.8|||||2-Sided|95.0|0.51|1.23||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684102|NCT01193335|3097797|Superiority or Other||GMT Ratio|0.9|||||2-Sided|95.0|0.56|1.37||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684103|NCT01193335|3097797|Superiority or Other||GMT Ratio|1.0|||||2-Sided|95.0|0.81|1.32||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684104|NCT01193335|3097797|Superiority or Other||GMT Ratio|0.3|||||2-Sided|95.0|0.11|0.65||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684105|NCT01193335|3097797|Superiority or Other||GMT Ratio|0.6|||||2-Sided|95.0|0.25|1.3||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684106|NCT01193335|3097797|Superiority or Other||GMT Ratio|0.3|||||2-Sided|95.0|0.1|0.76||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684107|NCT01193335|3097797|Superiority or Other||GMT Ratio|0.7|||||2-Sided|95.0|0.38|1.44||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684108|NCT01193335|3097797|Superiority or Other||GMT Ratio|0.6|||||2-Sided|95.0|0.22|1.53||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684109|NCT01193335|3097797|Superiority or Other||GMT Ratio|1.0|||||2-Sided|95.0|0.41|2.63||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684110|NCT01193335|3097797|Superiority or Other||GMT Ratio|0.8|||||2-Sided|95.0|0.35|2.05||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684111|NCT01193335|3097798|Superiority or Other||GMT Ratio|0.7|||||2-Sided|95.0|0.52|0.88||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684112|NCT01193335|3097798|Superiority or Other||GMT Ratio|0.9|||||2-Sided|95.0|0.74|1.15||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684113|NCT01193335|3097798|Superiority or Other||GMT Ratio|0.6|||||2-Sided|95.0|0.47|0.85||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684114|NCT01193335|3097798|Superiority or Other||GMT Ratio|0.6|||||2-Sided|95.0|0.45|0.91||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684115|NCT01193335|3097798|Superiority or Other||GMT Ratio|0.9|||||2-Sided|95.0|0.76|1.17||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684116|NCT01193335|3097798|Superiority or Other||GMT Ratio|0.5|||||2-Sided|95.0|0.38|0.81||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684117|NCT01193335|3097798|Superiority or Other||GMT Ratio|0.6|||||2-Sided|95.0|0.4|1.01||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684118|NCT01193335|3097798|Superiority or Other||GMT Ratio|0.6|||||2-Sided|95.0|0.31|1.1||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684119|NCT01193335|3097798|Superiority or Other||GMT Ratio|0.5|||||2-Sided|95.0|0.34|0.87||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684120|NCT01193335|3097798|Superiority or Other||GMT Ratio|0.8|||||2-Sided|95.0|0.54|1.14||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684121|NCT01193335|3097798|Superiority or Other||GMT Ratio|0.7|||||2-Sided|95.0|0.41|1.31||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684122|NCT01193335|3097798|Superiority or Other||GMT Ratio|0.9|||||2-Sided|95.0|0.54|1.4||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684123|NCT01193335|3097798|Superiority or Other||GMT Ratio|0.7|||||2-Sided|95.0|0.45|0.97||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684124|NCT01193335|3097799|Superiority or Other||GMT Ratio|0.8|||||2-Sided|95.0|0.52|1.37||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684125|NCT01193335|3097799|Superiority or Other||GMT Ratio|1.2|||||2-Sided|95.0|0.58|2.53||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684126|NCT01193335|3097799|Superiority or Other||GMT Ratio|0.5|||||2-Sided|95.0|0.24|1.04||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684127|NCT01193335|3097799|Superiority or Other||GMT Ratio|1.0|||||2-Sided|95.0|0.82|1.31||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684128|NCT01193335|3097799|Superiority or Other||GMT Ratio|1.0|||||2-Sided|95.0|0.68|1.33||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684129|NCT01193335|3097799|Superiority or Other||GMT Ratio|1.3|||||2-Sided|95.0|1.0|1.6||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684130|NCT01193335|3097799|Superiority or Other||GMT Ratio|0.7|||||2-Sided|95.0|0.35|1.46||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684131|NCT01193335|3097799|Superiority or Other||GMT Ratio|1.3|||||2-Sided|95.0|0.97|1.77||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684132|NCT01193335|3097799|Superiority or Other||GMT Ratio|0.6|||||2-Sided|95.0|0.24|1.55||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684133|NCT01193335|3097799|Superiority or Other||GMT Ratio|0.6|||||2-Sided|95.0|0.33|1.17||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684134|NCT01193335|3097799|Superiority or Other||GMT Ratio|1.5|||||2-Sided|95.0|0.76|3.12||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684135|NCT01193335|3097799|Superiority or Other||GMT Ratio|0.8|||||2-Sided|95.0|0.37|1.71||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684136|NCT01193335|3097799|Superiority or Other||GMT Ratio|0.7|||||2-Sided|95.0|0.37|1.44||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684137|NCT01193335|3097800|Superiority or Other||GMT Ratio|1.2|||||2-Sided|95.0|0.89|1.51||||||Serotype 19A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684138|NCT01193335|3097800|Superiority or Other||GMT Ratio|1.0|||||2-Sided|95.0|0.78|1.39||||||Serotype 7F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684139|NCT01193335|3097800|Superiority or Other||GMT Ratio|1.2|||||2-Sided|95.0|0.88|1.68||||||Serotype 6A: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684140|NCT01193335|3097800|Superiority or Other||GMT Ratio|0.6|||||2-Sided|95.0|0.36|0.94||||||Serotype 5: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684141|NCT01193335|3097800|Superiority or Other||GMT Ratio|1.1|||||2-Sided|95.0|0.83|1.41||||||Serotype 3: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684142|NCT01193335|3097800|Superiority or Other||GMT Ratio|0.8|||||2-Sided|95.0|0.56|1.15||||||Serotype 1: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684143|NCT01193335|3097800|Superiority or Other||GMT Ratio|1.3|||||2-Sided|95.0|0.8|1.99||||||Serotype 23F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684144|NCT01193335|3097800|Superiority or Other||GMT Ratio|1.2|||||2-Sided|95.0|0.82|1.89||||||Serotype 19F: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684145|NCT01193335|3097800|Superiority or Other||GMT Ratio|1.4|||||2-Sided|95.0|1.01|2.0||||||Serotype 18C: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684146|NCT01193335|3097800|Superiority or Other||GMT Ratio|1.3|||||2-Sided|95.0|0.8|1.98||||||Serotype 14: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684147|NCT01193335|3097800|Superiority or Other||GMT Ratio|0.7|||||2-Sided|95.0|0.26|1.93||||||Serotype 9V: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684148|NCT01193335|3097800|Superiority or Other||GMT Ratio|1.1|||||2-Sided|95.0|0.59|2.2||||||Serotype 6B: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684149|NCT01193335|3097800|Superiority or Other||GMT Ratio|1.3|||||2-Sided|95.0|0.99|1.81||||||Serotype 4: Ratio of GMTs calculated by back transforming the mean difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684150|NCT01193335|3097806|Superiority or Other||GMC Ratio|0.53|||||2-Sided|95.0|0.37|0.78||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684151|NCT01193335|3097806|Superiority or Other||GMC Ratio|0.89|||||2-Sided|95.0|0.7|1.13||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684152|NCT01193335|3097806|Superiority or Other||GMC Ratio|0.67|||||2-Sided|95.0|0.47|0.95||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684153|NCT01193335|3097806|Superiority or Other||GMC Ratio|0.68|||||2-Sided|95.0|0.5|0.92||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684154|NCT01193335|3097806|Superiority or Other||GMC Ratio|0.66|||||2-Sided|95.0|0.39|1.11||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684155|NCT01193335|3097806|Superiority or Other||GMC Ratio|0.82|||||2-Sided|95.0|0.63|1.07||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684156|NCT01193335|3097806|Superiority or Other||GMC Ratio|0.56|||||2-Sided|95.0|0.38|0.83||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684157|NCT01193335|3097806|Superiority or Other||GMC Ratio|0.45|||||2-Sided|95.0|0.29|0.71||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684158|NCT01193335|3097806|Superiority or Other||GMC Ratio|0.56|||||2-Sided|95.0|0.4|0.78||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684159|NCT01193335|3097806|Superiority or Other||GMC Ratio|0.77|||||2-Sided|95.0|0.51|1.17||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684160|NCT01193335|3097806|Superiority or Other||GMC Ratio|0.74|||||2-Sided|95.0|0.54|1.03||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684161|NCT01193335|3097806|Superiority or Other||GMC Ratio|0.53|||||2-Sided|95.0|0.38|0.76||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684162|NCT01193335|3097806|Superiority or Other||GMC Ratio|0.8|||||2-Sided|95.0|0.61|1.03||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684163|NCT01193335|3097807|Superiority or Other||GMC Ratio|0.51|||||2-Sided|95.0|0.36|0.72||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684164|NCT01193335|3097807|Superiority or Other||GMC Ratio|0.82|||||2-Sided|95.0|0.67|1.02||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684165|NCT01193335|3097807|Superiority or Other||GMC Ratio|0.68|||||2-Sided|95.0|0.52|0.88||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684166|NCT01193335|3097807|Superiority or Other||GMC Ratio|0.67|||||2-Sided|95.0|0.52|0.87||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684167|NCT01193335|3097807|Superiority or Other||GMC Ratio|0.59|||||2-Sided|95.0|0.39|0.9||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684168|NCT01193335|3097807|Superiority or Other||GMC Ratio|0.76|||||2-Sided|95.0|0.61|0.94||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684169|NCT01193335|3097807|Superiority or Other||GMC Ratio|0.47|||||2-Sided|95.0|0.35|0.64||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684170|NCT01193335|3097807|Superiority or Other||GMC Ratio|0.54|||||2-Sided|95.0|0.4|0.72||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684171|NCT01193335|3097807|Superiority or Other||GMC Ratio|0.5|||||2-Sided|95.0|0.37|0.67||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684172|NCT01193335|3097807|Superiority or Other||GMC Ratio|0.83|||||2-Sided|95.0|0.61|1.12||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684173|NCT01193335|3097807|Superiority or Other||GMC Ratio|0.62|||||2-Sided|95.0|0.46|0.84||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684174|NCT01193335|3097807|Superiority or Other||GMC Ratio|0.63|||||2-Sided|95.0|0.48|0.83||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684175|NCT01193335|3097807|Superiority or Other||GMC Ratio|0.81|||||2-Sided|95.0|0.63|1.04||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684176|NCT01193335|3097808|Superiority or Other||GMC Ratio|0.63|||||2-Sided|95.0|0.49|0.81||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684177|NCT01193335|3097808|Superiority or Other||GMC Ratio|0.83|||||2-Sided|95.0|0.69|1.0||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684178|NCT01193335|3097808|Superiority or Other||GMC Ratio|0.72|||||2-Sided|95.0|0.57|0.9||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684179|NCT01193335|3097808|Superiority or Other||GMC Ratio|0.71|||||2-Sided|95.0|0.58|0.87||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684180|NCT01193335|3097808|Superiority or Other||GMC Ratio|0.92|||||2-Sided|95.0|0.73|1.15||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684181|NCT01193335|3097808|Superiority or Other||GMC Ratio|0.81|||||2-Sided|95.0|0.64|1.03||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684182|NCT01193335|3097808|Superiority or Other||GMC Ratio|0.61|||||2-Sided|95.0|0.46|0.79||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684183|NCT01193335|3097808|Superiority or Other||GMC Ratio|0.63|||||2-Sided|95.0|0.48|0.83||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684184|NCT01193335|3097808|Superiority or Other||GMC Ratio|0.84|||||2-Sided|95.0|0.66|1.08||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684185|NCT01193335|3097808|Superiority or Other||GMC Ratio|0.84|||||2-Sided|95.0|0.66|1.07||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684186|NCT01193335|3097808|Superiority or Other||GMC Ratio|0.75|||||2-Sided|95.0|0.61|0.93||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684187|NCT01193335|3097808|Superiority or Other||GMC Ratio|0.61|||||2-Sided|95.0|0.47|0.79||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684188|NCT01193335|3097808|Superiority or Other||GMC Ratio|0.65|||||2-Sided|95.0|0.51|0.82||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684189|NCT01193335|3097809|Superiority or Other||GMC Ratio|0.55|||||2-Sided|95.0|0.42|0.72||||||Serotype 19A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684190|NCT01193335|3097809|Superiority or Other||GMC Ratio|0.86|||||2-Sided|95.0|0.71|1.03||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684191|NCT01193335|3097809|Superiority or Other||GMC Ratio|0.54|||||2-Sided|95.0|0.41|0.7||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684192|NCT01193335|3097809|Superiority or Other||GMC Ratio|0.7|||||2-Sided|95.0|0.56|0.88||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684265|NCT01193257|3097849|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|||P-values test for odds ratio equal to 1.|
1684876|NCT01185782|3099206|Superiority or Other|||||||0.852|||||||Chi-squared||||
1684193|NCT01193335|3097809|Superiority or Other||GMC Ratio|0.6|||||2-Sided|95.0|0.41|0.87||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684194|NCT01193335|3097809|Superiority or Other||GMC Ratio|0.96|||||2-Sided|95.0|0.77|1.2||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684195|NCT01193335|3097809|Superiority or Other||GMC Ratio|0.6|||||2-Sided|95.0|0.43|0.83||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684196|NCT01193335|3097809|Superiority or Other||GMC Ratio|0.73|||||2-Sided|95.0|0.58|0.92||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.|
1684197|NCT01193335|3097809|Superiority or Other||GMC Ratio|1.06|||||2-Sided|95.0|0.85|1.32||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.|
1684198|NCT01193335|3097809|Superiority or Other||GMC Ratio|0.86|||||2-Sided|95.0|0.66|1.12||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.|
1684199|NCT01193335|3097809|Superiority or Other||GMC Ratio|0.64|||||2-Sided|95.0|0.51|0.8||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684200|NCT01193335|3097809|Superiority or Other||GMC Ratio|0.51|||||2-Sided|95.0|0.39|0.66||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684201|NCT01193335|3097809|Superiority or Other||GMC Ratio|0.76|||||2-Sided|95.0|0.6|0.97||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the ratio difference of the logarithms of the measures.|
1684202|NCT01193335|3097811|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-4.25|4.31||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684203|NCT01193335|3097811|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-4.25|4.31||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684204|NCT01193335|3097811|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-4.25|4.31||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684205|NCT01193335|3097811|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-4.25|4.31||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684206|NCT01193335|3097811|Superiority or Other||Percent difference|-8.72|||||2-Sided|95.0|-21.93|4.42||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684207|NCT01193335|3097811|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-4.25|4.31||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684208|NCT01193335|3097811|Superiority or Other||Percent difference|-1.16|||||2-Sided|95.0|-6.32|3.1||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684209|NCT01193335|3097811|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-4.25|4.31||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684210|NCT01193335|3097811|Superiority or Other||Percent difference|1.15|||||2-Sided|95.0|-3.13|6.24||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684211|NCT01193335|3097811|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-4.25|4.31||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684212|NCT01193335|3097811|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-4.25|4.31||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684213|NCT01193335|3097811|Superiority or Other||Percent difference|-2.33|||||2-Sided|95.0|-8.15|1.96||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684214|NCT01193335|3097811|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-4.25|4.31||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684215|NCT01193335|3097813|Superiority or Other||GMFR ratio|1.15|||||2-Sided|95.0|0.88|1.52||||||Serotype 19A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).|
1684532|NCT01192828|3098002|Other|Descriptive analysis||||||0.1|||||||t-test, 2 sided||||
1684216|NCT01193335|3097813|Superiority or Other||GMFR ratio|0.96|||||2-Sided|95.0|0.78|1.18||||||Serotype 7F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).|
1684217|NCT01193335|3097813|Superiority or Other||GMFR ratio|1.36|||||2-Sided|95.0|1.02|1.82||||||Serotype 6A: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).|
1684218|NCT01193335|3097813|Superiority or Other||GMFR ratio|1.0|||||2-Sided|95.0|0.81|1.24||||||Serotype 5: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).|
1684219|NCT01193335|3097813|Superiority or Other||GMFR ratio|1.46|||||2-Sided|95.0|1.03|2.05||||||Serotype 3: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).|
1684220|NCT01193335|3097813|Superiority or Other||GMFR ratio|0.84|||||2-Sided|95.0|0.64|1.11||||||Serotype 1: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.|
1684221|NCT01193335|3097813|Superiority or Other||GMFR ratio|1.0|||||2-Sided|95.0|0.74|1.33||||||Serotype 23F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale.|
1684222|NCT01193335|3097813|Superiority or Other||GMFR ratio|0.88|||||2-Sided|95.0|0.65|1.19||||||Serotype 19F: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).|
1684223|NCT01193335|3097813|Superiority or Other||GMFR ratio|0.8|||||2-Sided|95.0|0.63|1.02||||||Serotype 18C: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).|
1684224|NCT01193335|3097813|Superiority or Other||GMFR ratio|0.97|||||2-Sided|95.0|0.74|1.26||||||Serotype 14: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).|
1684225|NCT01193335|3097813|Superiority or Other||GMFR ratio|1.19|||||2-Sided|95.0|0.96|1.47||||||Serotype 9V: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).|
1684226|NCT01193335|3097813|Superiority or Other||GMFR ratio|1.24|||||2-Sided|95.0|0.95|1.62||||||Serotype 6B: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).|
1684227|NCT01193335|3097813|Superiority or Other||GMFR Ratio|0.85|||||2-Sided|95.0|0.63|1.14||||||Serotype 4: GMFR ratio was calculated by back transforming the GMFR difference between the groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on Student t distribution for the ratio difference of logarithms of the measures (Group 1 – Group 2).|
1684228|NCT01193335|3097814|Superiority or Other|||||||0.782|||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.|
1684229|NCT01193335|3097814|Superiority or Other|||||||0.794|||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.|
1684230|NCT01193335|3097815|Superiority or Other|||||||0.357|||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.|
1684231|NCT01193335|3097815|Superiority or Other|||||||0.183|||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.|
1684232|NCT01193335|3097816|Superiority or Other||||||>|0.99|||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.|
1684233|NCT01193335|3097816|Superiority or Other||||||>|0.531|||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.|
1684234|NCT01193335|3097817|Superiority or Other||||||>|0.99|||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.|
1684235|NCT01193335|3097817|Superiority or Other||||||>|0.704|||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.|
1684236|NCT01193335|3097818|Superiority or Other|||||||0.051|||||||Fisher Exact|||SAEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.|
1684237|NCT01193335|3097818|Superiority or Other|||||||0.668|||||||Fisher Exact|||AEs: Two sided Fisher exact test, was used to calculate difference between vaccine groups.|
1684238|NCT01193335|3097827|Superiority or Other||GMC ratio|0.85|||||2-Sided|95.0|0.68|1.07||||||Serotype 19: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684239|NCT01193335|3097827|Superiority or Other||GMC ratio|0.71|||||2-Sided|95.0|0.57|0.88||||||Serotype 7F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684240|NCT01193335|3097827|Superiority or Other||GMC ratio|0.61|||||2-Sided|95.0|0.45|0.82||||||Serotype 6A: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684533|NCT01192828|3098003|Other|Descriptive analysis.||||||0.16|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.|
1684241|NCT01193335|3097827|Superiority or Other||GMC ratio|0.54|||||2-Sided|95.0|0.4|0.72||||||Serotype 5: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684242|NCT01193335|3097827|Superiority or Other||GMC ratio|0.96|||||2-Sided|95.0|0.77|1.19||||||Serotype 3: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684243|NCT01193335|3097827|Superiority or Other||GMC ratio|0.7|||||2-Sided|95.0|0.55|0.89||||||Serotype 1: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684244|NCT01193335|3097827|Superiority or Other||GMC ratio|0.64|||||2-Sided|95.0|0.47|0.86||||||Serotype 23F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684245|NCT01193335|3097827|Superiority or Other||GMC ratio|0.72|||||2-Sided|95.0|0.58|0.9||||||Serotype 19F: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684246|NCT01193335|3097827|Superiority or Other||GMC ratio|1.0|||||2-Sided|95.0|0.8|1.25||||||Serotype 18C: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684247|NCT01193335|3097827|Superiority or Other||GMC ratio|1.23|||||2-Sided|95.0|0.92|1.65||||||Serotype 14: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684248|NCT01193335|3097827|Superiority or Other||GMC ratio|0.74|||||2-Sided|95.0|0.59|0.93||||||Serotype 9V: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684249|NCT01193335|3097827|Superiority or Other||GMC ratio|0.56|||||2-Sided|95.0|0.38|0.82||||||Serotype 6B: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684250|NCT01193335|3097827|Superiority or Other||GMC ratio|0.8|||||2-Sided|95.0|0.62|1.02||||||Serotype 4: Ratios of GMCs were calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures.|
1684251|NCT01193335|3097828|Superiority or Other||Percent difference|0.02|||||2-Sided|95.0|-4.54|4.68||||||Serotype 19A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684252|NCT01193335|3097828|Superiority or Other||Percent difference|0.02|||||2-Sided|95.0|-4.54|4.68||||||Serotype 7F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684253|NCT01193335|3097828|Superiority or Other||Percent difference|-12.19|||||2-Sided|95.0|-21.66|-3.26||||||Serotype 6A: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684254|NCT01193335|3097828|Superiority or Other||Percent difference|-19.0|||||2-Sided|95.0|-30.1|-7.16||||||Serotype 5: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684255|NCT01193335|3097828|Superiority or Other||Percent difference|-4.86|||||2-Sided|95.0|-14.4|4.39||||||Serotype 3: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684256|NCT01193335|3097828|Superiority or Other||Percent difference|-1.94|||||2-Sided|95.0|-9.07|4.86||||||Serotype 1: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684257|NCT01193335|3097828|Superiority or Other||Percent difference|-6.92|||||2-Sided|95.0|-16.19|1.89||||||Serotype 23F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684258|NCT01193335|3097828|Superiority or Other||Percent difference|0.02|||||2-Sided|95.0|-4.54|4.68||||||Serotype 19F: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684259|NCT01193335|3097828|Superiority or Other||Percent difference|2.12|||||2-Sided|95.0|-4.09|8.89||||||Serotype 18C: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684260|NCT01193335|3097828|Superiority or Other||Percent difference|2.06|||||2-Sided|95.0|-1.71|7.25||||||Serotype 14: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684261|NCT01193335|3097828|Superiority or Other||Percent difference|0.06|||||2-Sided|95.0|-5.84|6.05||||||Serotype 9V: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684262|NCT01193335|3097828|Superiority or Other||Percent difference|-14.9|||||2-Sided|95.0|-26.4|-3.21||||||Serotype 6B: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684263|NCT01193335|3097828|Superiority or Other||Percent difference|-2.0|||||2-Sided|95.0|-7.65|2.88||||||Serotype 4: Exact 2-sided, 95% CI was computed based on the procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|
1684264|NCT01193257|3097848|Superiority or Other|||||||0.12778|||||||Regression, Logistic|||P-values test for odds ratio equal to 1.|
1684266|NCT01193257|3097850|Superiority or Other||Hazard Ratio (HR)|0.76||||0.00038|2-Sided|95.0|0.653|0.885|||Log Rank|||Hazard ratio is based on a stratified Cox’s proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening (<=4, >4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.|
1684267|NCT01193257|3097851|Superiority or Other||Hazard Ratio (HR)|0.875||||0.12085|2-Sided|95.0|0.739|1.036|||Log Rank|||Hazard ratio is based on a stratified Cox’s proportional hazard regression model with stratification factors region (North America, Europe and Rest of World) and brief pain inventory-short form (BPI-SF) worst pain score at screening ([less than or equal to] <=4, greater than [>] 4) with treatment as a factor in the model. A hazard ratio less than 1 for the treatment indicates better prevention of the death in the Orteronel arm as compared to placebo arm.|
1684268|NCT01193244|3097870|Superiority or Other||Hazard Ratio (HR)|0.885||||0.33906||95.0|0.688|1.138|||Log Rank|||Hazard ratio is based on a stratified Cox’s proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio less than (<) 1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at baseline.|
1684269|NCT01193244|3097871|Superiority or Other||Odds Ratio (OR)|1.712||||0.001||95.0|1.235|2.373|||Regression, Logistic|||Logistic regression model with prognostic factors: region; radiographic disease progression at baseline; age; race; baseline ECOG score; Gleason score at initial diagnosis; baseline PSA, natural log scale; presence of visceral disease; alkaline phosphatase; lactate dehydrogenase; and hemoglobin. Odds ratio > 1 favored orteronel. P-values tested for odds ratio equal to 1.|
1684270|NCT01193244|3097872|Superiority or Other||Odds Ratio (OR)|2.166|||<|0.001||95.0|1.724|2.721|||Regression, Logistic|||Logistic regression model with prognostic factors: region; radiographic disease progression at baseline; age; race; baseline Eastern Cooperative Oncology Group (ECOG) score; Gleason score at initial diagnosis; baseline PSA, natural log scale; presence of visceral disease; alkaline phosphatase; lactate dehydrogenase; and hemoglobin. Odds ratio greater than (>)1 favored orteronel. P-values tested for odds ratio equal to 1.|
1684271|NCT01193244|3097873|Superiority or Other||Hazard Ratio (HR)|0.963||||0.59755||95.0|0.838|1.107|||Log Rank|||Hazard ratio is based on a stratified Cox’s proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio <1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at baseline.|
1684272|NCT01193244|3097874|Superiority or Other||Hazard Ratio (HR)|0.707|||<|1e-05||95.0|0.626|0.799|||Log Rank|||Hazard ratio is based on a stratified Cox’s proportional hazard regression model with stratification factors of region and radiographic disease progression at baseline with treatment as a factor in the model. A hazard ratio less than (<) 1 indicated better prevention of death in the orteronel group compared to the placebo group. From log-rank test stratified by region and radiographic disease progression at Baseline.|
1684273|NCT01193218|3097876|Superiority or Other||Mean Difference (Final Values)|-36.6|Standard Error of the Mean|2.5|<|0.0001|2-Sided|95.0|-41.51|-31.69|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 50mg minus placebo|
1684274|NCT01193218|3097876|Superiority or Other||Mean Difference (Final Values)|-37.75|Standard Error of the Mean|2.5|<|0.0001|2-Sided|95.0|-42.66|-32.84|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 25mg minus placebo|
1684275|NCT01193218|3097876|Superiority or Other||Mean Difference (Final Values)|-29.34|Standard Error of the Mean|2.5|<|0.0001|2-Sided|95.0|-34.25|-24.42|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 10mg minus placebo|
1684276|NCT01193218|3097876|Superiority or Other||Mean Difference (Final Values)|-26.7|Standard Error of the Mean|2.5|<|0.0001|2-Sided|95.0|-31.61|-21.8|||ANCOVA|treatment, renal function, number of previous antidiabetic medication as fixed effects, baseline fasting plasma glucose, baseline HbA1c as covariates||Difference calculated as empa 5mg minus placebo|
1684277|NCT01193218|3097877|Superiority or Other||Odds Ratio (OR)|44.906|||<|0.0001|2-Sided|95.0|12.12|99.99|||Regression, Logistic|The model includes ‘treatment’, ‘renal function’, ‘number of previous antidiabetic medications’ and ‘continuous baseline HbA1c’.|The upper limit of confidence interval is actually >99.99|Odds ratio calculated as the odds of Empa 50mg divided by the odds of placebo|
1684278|NCT01193218|3097877|Superiority or Other||Odds Ratio (OR)|27.624|||<|0.0001|2-Sided|95.0|7.601|99.99|||Regression, Logistic|The model includes ‘treatment’, ‘renal function’, ‘number of previous antidiabetic medications’ and ‘continuous baseline HbA1c’.|The upper limit of confidence interval is actually >99.99|Odds ratio calculated as the odds of Empa 25mg divided by the odds of placebo|
1684279|NCT01193218|3097877|Superiority or Other||Odds Ratio (OR)|10.889|||<|0.0003|2-Sided|95.0|2.942|40.301|||Regression, Logistic|The model includes ‘treatment’, ‘renal function’, ‘number of previous antidiabetic medications’ and ‘continuous baseline HbA1c’.||Odds ratio calculated as the odds of Empa 10mg divided by the odds of placebo|
1684280|NCT01193218|3097877|Superiority or Other||Odds Ratio (OR)|19.367|||<|0.0001|2-Sided|95.0|5.34|70.236|||Regression, Logistic|The model includes ‘treatment’, ‘renal function’, ‘number of previous antidiabetic medications’ and ‘continuous baseline HbA1c’.||Odds ratio calculated as the odds of Empa 5mg divided by the odds of placebo|
1684281|NCT01193218|3097878|Superiority or Other||Mean Difference (Final Values)|-0.91|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-1.06|-0.76||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|‘treatment’, ‘renal function’, and ‘number of previous antidiabetic medication’ as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 50mg minus placebo|
1684534|NCT01192828|3098004|Other|Descriptive analysis||||||0.012|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed|
1684282|NCT01193218|3097878|Superiority or Other||Mean Difference (Final Values)|-0.95|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-1.1|-0.8||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|‘treatment’, ‘renal function’, and ‘number of previous antidiabetic medication’ as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 25mg minus placebo|
1684283|NCT01193218|3097878|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.85|-0.55||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|‘treatment’, ‘renal function’, and ‘number of previous antidiabetic medication’ as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 10mg minus placebo|
1684284|NCT01193218|3097878|Superiority or Other||Mean Difference (Final Values)|-0.72|Standard Error of the Mean|0.08|<|0.0001|2-Sided|95.0|-0.87|-0.57||the analyses were made sequentially compared with placebo from high dose of empagliflozin and the full significant level (5%) was maintained by the hierarchical procedure.|ANCOVA|‘treatment’, ‘renal function’, and ‘number of previous antidiabetic medication’ as a fixed effect and baseline HbA1c as a covariate||Difference calculated as empa 5mg minus placebo|
1684285|NCT01193153|3097888|Superiority or Other||Least Square Mean Difference|4.5|||<|0.001|2-Sided|95.0|1.94|7.15||Change at Endpoint (Week 64/LOCF)|ANCOVA||||
1684286|NCT01193153|3097890|Superiority or Other||Least Square Mean Difference|3.3|Standard Error of the Mean|1.33||0.014|2-Sided|95.0|0.68|5.95||P-value based on change from DB baseline in PSP score and was analyzed using mixed-model repeated measures analysis of covariance based on observed data; within-participant repeated measures were modeled using an unstructured covariance matrix.|MMRM ANCOVA|||The null hypothesis is that there is no difference in the mean of the PSP total score between the two treatment groups.|
1684287|NCT01193153|3097891|Superiority or Other||Hazard Ratio (HR)|1.93||||0.238|2-Sided|95.0|0.65|5.78|||Regression, Cox|||Mood Symptoms (Mixed): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.|
1684288|NCT01193153|3097891|Superiority or Other||Hazard Ratio (HR)|3.12||||0.006|2-Sided|95.0|1.39|6.98|||Regression, Cox|||Mood Symptoms (Depressive): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.|
1684289|NCT01193153|3097891|Superiority or Other||Hazard Ratio (HR)|3.62||||0.012|2-Sided|95.0|1.32|9.89|||Regression, Cox|||Mood Symptoms (Manic): Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.|
1684290|NCT01193153|3097891|Superiority or Other||Hazard Ratio (HR)|2.93|||<|0.001|2-Sided|95.0|1.7|5.04|||Regression, Cox|||Mood Symptoms (Any Mood Symptoms):Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.|
1684291|NCT01193153|3097891|Superiority or Other||Hazard Ratio (HR)|2.82|||<|0.001|2-Sided|95.0|1.7|4.67|||Regression, Cox|||Psychotic Symptoms: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.|
1684292|NCT01193153|3097891|Superiority or Other||Hazard Ratio (HR)|2.03|||<|0.021|2-Sided|95.0|1.11|3.68|||Regression, Cox|||Adjunct therapy subset: Hazard ratio and corresponding p-value, and 95% CI were calculated from Cox proportional hazard regression model.|
1684293|NCT01193153|3097891|Superiority or Other||Hazard Ratio (HR)|3.38|||<|0.002|2-Sided|95.0|1.57|7.28|||Regression, Cox|||Monotherapy subset: Hazard ratio and corresponding p-value, and 95% Confidence Interval (CI) were calculated from Cox proportional hazard regression model.|
1684294|NCT01193153|3097891|Superiority or Other||Hazard Ratio (HR)|2.49|||<|0.001|2-Sided|95.0|1.55|3.99|||Log Rank|||All participants: p-value was calculated using log-rank test.|
1684295|NCT01193127|3097892|Superiority or Other|||||||0.104||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684296|NCT01193127|3097892|Superiority or Other|||||||0.253||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684297|NCT01193127|3097892|Superiority or Other|||||||0.711||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684298|NCT01193127|3097893|Superiority or Other|||||||0.092||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel||||
1684299|NCT01193127|3097893|Superiority or Other|||||||0.0839||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel||||
1684300|NCT01193127|3097893|Superiority or Other|||||||0.157||||||Ocular pain medications will be identified by reviewing concomitant medications. Subject incidence of ocular pain medication use at day 1 and post day 1 will be presented. Treatment comparisons will be performed using methodology 1.|Cochran-Mantel-Haenszel||||
1684301|NCT01193127|3097894|Superiority or Other|||||||0.8946||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684302|NCT01193127|3097894|Superiority or Other|||||||0.8318||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684303|NCT01193127|3097894|Superiority or Other|||||||0.4575||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684304|NCT01193127|3097896|Superiority or Other|||||||0.99||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684877|NCT01185782|3099207|Superiority or Other|||||||0.069|||||||t-test, 2 sided||||
1684305|NCT01193127|3097896|Superiority or Other|||||||0.459||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684306|NCT01193127|3097896|Superiority or Other|||||||0.489||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684307|NCT01193127|3097897|Superiority or Other|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684308|NCT01193127|3097897|Superiority or Other|||||||0.424||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684309|NCT01193127|3097897|Superiority or Other|||||||0.822||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684310|NCT01193127|3097898|Superiority or Other|||||||0.026||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684311|NCT01193127|3097898|Superiority or Other|||||||0.021||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684312|NCT01193127|3097898|Superiority or Other|||||||0.206||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684313|NCT01193127|3097899|Superiority or Other|||||||0.029||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684314|NCT01193127|3097899|Superiority or Other|||||||0.183||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684315|NCT01193127|3097899|Superiority or Other|||||||0.086||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684316|NCT01193127|3097900|Superiority or Other|||||||0.31||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684317|NCT01193127|3097900|Superiority or Other|||||||0.71||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684318|NCT01193127|3097900|Superiority or Other|||||||0.134||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684319|NCT01193127|3097901|Superiority or Other|||||||0.987||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684320|NCT01193127|3097901|Superiority or Other|||||||0.166||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684321|NCT01193127|3097901|Superiority or Other|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups were based on Wilcoxon rank-sum test. For subjects with mean count > 30, the mean count was imputed as 45 for the purpose of treatment comparisons.|Wilcoxon rank-sum test||||
1684322|NCT01193127|3097902|Superiority or Other|||||||0.787||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684323|NCT01193127|3097902|Superiority or Other|||||||0.592||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684324|NCT01193127|3097902|Superiority or Other|||||||0.773||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684325|NCT01193127|3097903|Superiority or Other|||||||0.711||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684326|NCT01193127|3097903|Superiority or Other|||||||0.619||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684327|NCT01193127|3097903|Superiority or Other|||||||0.842||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684328|NCT01193127|3097904|Superiority or Other|||||||0.281||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684535|NCT01192828|3098005|Other|Descriptive analysis||||||0.014|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed|
1706031|NCT00904033|3137737|Other|||||||0.19|||||||ANCOVA||||
1684329|NCT01193127|3097904|Superiority or Other|||||||0.476||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684330|NCT01193127|3097904|Superiority or Other|||||||0.824||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684331|NCT01193127|3097905|Superiority or Other|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684332|NCT01193127|3097905|Superiority or Other|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684333|NCT01193127|3097905|Superiority or Other|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684334|NCT01193127|3097906|Superiority or Other|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684335|NCT01193127|3097906|Superiority or Other|||||||0.335||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684336|NCT01193127|3097906|Superiority or Other|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684337|NCT01193127|3097907|Superiority or Other|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684338|NCT01193127|3097907|Superiority or Other|||||||0.647||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684339|NCT01193127|3097907|Superiority or Other|||||||0.559||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684340|NCT01193127|3097908|Superiority or Other|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684341|NCT01193127|3097908|Superiority or Other|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684342|NCT01193127|3097908|Superiority or Other|||||||0.317||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684343|NCT01193127|3097909|Superiority or Other|||||||0.7599||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684344|NCT01193127|3097909|Superiority or Other|||||||0.9146||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684345|NCT01193127|3097909|Superiority or Other|||||||0.1374||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684346|NCT01193127|3097910|Superiority or Other|||||||0.6144||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684347|NCT01193127|3097910|Superiority or Other|||||||0.3763||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684348|NCT01193127|3097910|Superiority or Other|||||||0.5369||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684349|NCT01193127|3097911|Superiority or Other|||||||0.0775||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684350|NCT01193127|3097911|Superiority or Other|||||||0.0314||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684351|NCT01193127|3097911|Superiority or Other|||||||0.0688||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684352|NCT01193127|3097912|Superiority or Other|||||||0.0765||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684353|NCT01193127|3097912|Superiority or Other|||||||0.6499||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684354|NCT01193127|3097912|Superiority or Other|||||||0.4099||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684355|NCT01193127|3097913|Superiority or Other|||||||0.1495||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684356|NCT01193127|3097913|Superiority or Other|||||||0.8084||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684357|NCT01193127|3097913|Superiority or Other|||||||0.051||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684878|NCT01185782|3099208|Superiority or Other|||||||0.087|||||||t-test, 2 sided||||
1684358|NCT01193127|3097914|Superiority or Other|||||||0.8819||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684359|NCT01193127|3097914|Superiority or Other|||||||0.2712||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684360|NCT01193127|3097914|Superiority or Other|||||||0.4222||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684361|NCT01193127|3097915|Superiority or Other|||||||0.5263||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684362|NCT01193127|3097915|Superiority or Other|||||||0.2066||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684363|NCT01193127|3097915|Superiority or Other|||||||0.2066||||||Treatment comparisons between OMS302 and each of the other three groups are based on ANOVA model with covariates treatment group and the LOCS II grade group.|ANOVA||||
1684364|NCT01193127|3097916|Superiority or Other|||||||0.668||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684365|NCT01193127|3097916|Superiority or Other|||||||0.825||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|WIlcoxon rank-sum test||||
1684366|NCT01193127|3097916|Superiority or Other|||||||0.675||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684367|NCT01193127|3097917|Superiority or Other|||||||0.463||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684368|NCT01193127|3097917|Superiority or Other|||||||0.903||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684369|NCT01193127|3097917|Superiority or Other|||||||0.22||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684370|NCT01193127|3097918|Superiority or Other|||||||0.725||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684371|NCT01193127|3097918|Superiority or Other|||||||0.736||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684372|NCT01193127|3097918|Superiority or Other|||||||0.626||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684373|NCT01193127|3097919|Superiority or Other|||||||0.12||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684374|NCT01193127|3097919|Superiority or Other|||||||0.092||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wicoxon rank-sum test||||
1684375|NCT01193127|3097919|Superiority or Other|||||||0.086||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684376|NCT01193127|3097920|Superiority or Other|||||||0.095||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684377|NCT01193127|3097920|Superiority or Other|||||||0.089||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684378|NCT01193127|3097920|Superiority or Other|||||||0.701||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684379|NCT01193127|3097921|Superiority or Other|||||||0.921||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wicoxon rank-sum test||||
1684380|NCT01193127|3097921|Superiority or Other|||||||0.547||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684381|NCT01193127|3097921|Superiority or Other|||||||0.172||||||Treatment comparisons between OMS302 and each of the other three groups are based on Wilcoxon rank-sum test.|Wilcoxon rank-sum test||||
1684382|NCT01193127|3097922|Superiority or Other|||||||0.291||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684383|NCT01193127|3097922|Superiority or Other|||||||0.357||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684384|NCT01193127|3097922|Superiority or Other|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684385|NCT01193127|3097923|Superiority or Other|||||||0.078||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684386|NCT01193127|3097923|Superiority or Other|||||||0.005||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684387|NCT01193127|3097923|Superiority or Other|||||||0.075||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684388|NCT01193127|3097924|Superiority or Other|||||||0.31||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684389|NCT01193127|3097924|Superiority or Other|||||||0.169||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684390|NCT01193127|3097924|Superiority or Other|||||||0.476||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684391|NCT01193127|3097925|Superiority or Other|||||||0.472||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684392|NCT01193127|3097925|Superiority or Other|||||||0.059||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684393|NCT01193127|3097925|Superiority or Other|||||||0.031||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684394|NCT01193127|3097926|Superiority or Other|||||||0.555||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684395|NCT01193127|3097926|Superiority or Other|||||||0.265||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684396|NCT01193127|3097926|Superiority or Other|||||||0.374||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684397|NCT01193127|3097927|Superiority or Other|||||||0.477||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684398|NCT01193127|3097927|Superiority or Other|||||||0.348||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684399|NCT01193127|3097927|Superiority or Other|||||||0.778||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684400|NCT01193127|3097928|Superiority or Other|||||||0.23||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684401|NCT01193127|3097928|Superiority or Other|||||||0.39||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684402|NCT01193127|3097928|Superiority or Other|||||||0.32||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684403|NCT01193127|3097929|Superiority or Other|||||||0.096||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684404|NCT01193127|3097929|Superiority or Other|||||||0.345||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684405|NCT01193127|3097929|Superiority or Other|||||||0.271||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684406|NCT01193127|3097930|Superiority or Other|||||||0.298||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684407|NCT01193127|3097930|Superiority or Other|||||||0.292||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684408|NCT01193127|3097930|Superiority or Other|||||||0.018||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684409|NCT01193127|3097931|Superiority or Other|||||||0.755||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684410|NCT01193127|3097931|Superiority or Other|||||||0.564||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684411|NCT01193127|3097931|Superiority or Other|||||||0.228||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684412|NCT01193127|3097932|Superiority or Other|||||||0.292||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684413|NCT01193127|3097932|Superiority or Other|||||||0.355||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684414|NCT01193127|3097932|Superiority or Other|||||||0.752||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684415|NCT01193127|3097933|Superiority or Other|||||||0.79||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684416|NCT01193127|3097933|Superiority or Other|||||||0.122||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684417|NCT01193127|3097933|Superiority or Other|||||||0.244||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684418|NCT01193127|3097934|Superiority or Other|||||||0.29|||||||Cochran-Mantel-Haenszel||||
1684419|NCT01193127|3097934|Superiority or Other|||||||0.602||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684420|NCT01193127|3097934|Superiority or Other|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684421|NCT01193127|3097935|Superiority or Other|||||||0.306||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684422|NCT01193127|3097935|Superiority or Other|||||||0.429||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684423|NCT01193127|3097935|Superiority or Other|||||||0.681||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684424|NCT01193127|3097936|Superiority or Other|||||||0.559|||||||Cochran-Mantel-Haenszel||||
1684425|NCT01193127|3097936|Superiority or Other|||||||0.362||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684426|NCT01193127|3097936|Superiority or Other|||||||0.173||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684427|NCT01193127|3097937|Superiority or Other|||||||0.549||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684428|NCT01193127|3097937|Superiority or Other|||||||0.552||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684429|NCT01193127|3097937|Superiority or Other|||||||0.811||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684430|NCT01193127|3097938|Superiority or Other|||||||0.596||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684431|NCT01193127|3097938|Superiority or Other|||||||0.438||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684432|NCT01193127|3097938|Superiority or Other|||||||0.945||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684433|NCT01193127|3097939|Superiority or Other|||||||0.245||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684434|NCT01193127|3097939|Superiority or Other|||||||0.406||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684435|NCT01193127|3097939|Superiority or Other|||||||0.463||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684436|NCT01193127|3097940|Superiority or Other|||||||0.353||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684437|NCT01193127|3097940|Superiority or Other|||||||0.362||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684438|NCT01193127|3097940|Superiority or Other|||||||0.528||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684439|NCT01193127|3097941|Superiority or Other|||||||0.336||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684440|NCT01193127|3097941|Superiority or Other|||||||0.778||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684441|NCT01193127|3097941|Superiority or Other|||||||0.632||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684442|NCT01193127|3097942|Superiority or Other|||||||0.336||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684443|NCT01193127|3097942|Superiority or Other|||||||0.977||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684444|NCT01193127|3097942|Superiority or Other|||||||0.789||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684445|NCT01193127|3097943|Superiority or Other|||||||0.303||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684446|NCT01193127|3097943|Superiority or Other|||||||0.667||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684447|NCT01193127|3097943|Superiority or Other|||||||1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684448|NCT01193127|3097944|Superiority or Other|||||||0.16||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684449|NCT01193127|3097944|Superiority or Other|||||||0.95||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684450|NCT01193127|3097944|Superiority or Other|||||||0.646||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684451|NCT01193127|3097945|Superiority or Other|||||||0.381||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684452|NCT01193127|3097945|Superiority or Other|||||||0.156||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684453|NCT01193127|3097945|Superiority or Other|||||||0.148||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684454|NCT01193127|3097946|Superiority or Other|||||||0.432||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684455|NCT01193127|3097946|Superiority or Other|||||||0.521||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684456|NCT01193127|3097946|Superiority or Other|||||||0.758||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684457|NCT01193127|3097947|Superiority or Other|||||||0.478||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684458|NCT01193127|3097947|Superiority or Other|||||||0.2||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Chi-squared, Corrected||||
1684459|NCT01193127|3097947|Superiority or Other|||||||0.401||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684460|NCT01193127|3097948|Superiority or Other|||||||0.589||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684461|NCT01193127|3097948|Superiority or Other|||||||0.211||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684462|NCT01193127|3097948|Superiority or Other|||||||0.825||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684463|NCT01193127|3097949|Superiority or Other|||||||0.291||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684464|NCT01193127|3097949|Superiority or Other|||||||0.298||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684465|NCT01193127|3097949|Superiority or Other|||||||0.124||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684466|NCT01193127|3097950|Superiority or Other|||||||0.369||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684467|NCT01193127|3097950|Superiority or Other|||||||0.355||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684468|NCT01193127|3097950|Superiority or Other|||||||0.695||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684469|NCT01193127|3097951|Superiority or Other|||||||0.467||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684470|NCT01193127|3097951|Superiority or Other|||||||0.442||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684471|NCT01193127|3097951|Superiority or Other|||||||0.642||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684472|NCT01193127|3097952|Superiority or Other|||||||0.525||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684473|NCT01193127|3097952|Superiority or Other|||||||0.029||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684474|NCT01193127|3097952|Superiority or Other|||||||0.1||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684475|NCT01193127|3097953|Superiority or Other|||||||0.039||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684562|NCT01192516|3098040|Superiority or Other|||||||0.36||||||Adjusted for age, gender, body mass index, and pain at baseline.|Mixed Models Analysis||||
1684476|NCT01193127|3097953|Superiority or Other|||||||0.519||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684477|NCT01193127|3097953|Superiority or Other|||||||0.106||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684478|NCT01193127|3097954|Superiority or Other|||||||0.045||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684479|NCT01193127|3097954|Superiority or Other|||||||0.326||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684480|NCT01193127|3097954|Superiority or Other|||||||0.663||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684481|NCT01193127|3097955|Superiority or Other|||||||0.167||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684482|NCT01193127|3097955|Superiority or Other|||||||0.191||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684483|NCT01193127|3097955|Superiority or Other|||||||0.186||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684484|NCT01193127|3097956|Superiority or Other|||||||0.412||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684485|NCT01193127|3097956|Superiority or Other|||||||0.553||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684486|NCT01193127|3097956|Superiority or Other|||||||0.893||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel- Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684487|NCT01193127|3097957|Superiority or Other|||||||0.606||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684488|NCT01193127|3097957|Superiority or Other|||||||0.202||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684489|NCT01193127|3097957|Superiority or Other|||||||0.081||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684490|NCT01193127|3097958|Superiority or Other|||||||0.021||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684491|NCT01193127|3097958|Superiority or Other|||||||0.742||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684492|NCT01193127|3097958|Superiority or Other|||||||0.085||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684493|NCT01193127|3097959|Superiority or Other|||||||0.16||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684494|NCT01193127|3097959|Superiority or Other|||||||0.48||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684495|NCT01193127|3097959|Superiority or Other|||||||0.812||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684496|NCT01193127|3097960|Superiority or Other|||||||0.439||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684497|NCT01193127|3097960|Superiority or Other|||||||0.09||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684498|NCT01193127|3097960|Superiority or Other|||||||0.48||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684499|NCT01193127|3097961|Superiority or Other|||||||0.497||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684500|NCT01193127|3097961|Superiority or Other|||||||0.051||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684501|NCT01193127|3097961|Superiority or Other|||||||0.177||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684502|NCT01193127|3097962|Superiority or Other|||||||0.226||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684503|NCT01193127|3097962|Superiority or Other|||||||0.162||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684563|NCT01192516|3098043|Superiority or Other|||||||0.06|||||||Mixed Models Analysis|Adjusted for age, gender, and body mass index.|||
1684504|NCT01193127|3097962|Superiority or Other|||||||0.229||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684505|NCT01193127|3097963|Superiority or Other|||||||0.025||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684506|NCT01193127|3097963|Superiority or Other|||||||0.769||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684507|NCT01193127|3097963|Superiority or Other|||||||0.63||||||Treatment comparisons between OMS302 and each of the other three groups are based on Cochran-Mantel-Haenszel test adjusting for the LOCS II grade group.|Cochran-Mantel-Haenszel||||
1684508|NCT01193127|3097964|Superiority or Other||least-squares mean difference|-5.9|Standard Error of the Mean|2.2||0.0093||95.0|-10.3|-1.5||Repeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates.|repeated measures model||OMS302 - PE||
1684509|NCT01193127|3097964|Superiority or Other||least-squares mean difference|-4.6|Standard Error of the Mean|2.2||0.0421||95.0|-8.9|-0.2||Repeated measures model includes treatment (OMS302, PE and vehicle), time point and LOCS II grade as covariates|repeated measures model||OMS302 - Vehicle (BSS)||
1684510|NCT01193127|3097965|Superiority or Other||least-squares mean difference|0.7|Standard Error of the Mean|0.1||0||95.0|0.5|0.9||Repeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates.|repeated measures model|OMS302 - ketorolac tromethamine|||
1684511|NCT01193127|3097965|Superiority or Other||least-squares mean difference|0.9|Standard Error of the Mean|0.1||0||95.0|0.6|1.1||Repeated measures model includes treatment (OMS302, ketorolac tromethamine, and vehicle), time-point and LOCS II grade as covariates|repeated measures model|All data time points collected used in the analysis.|OMS302 - Vehicle (BSS)||
1684512|NCT01193049|3097989|Superiority or Other||GM FR from Placebo: NE|0.61||||0.056|2-Sided|90.0|0.37|1.02||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in MIP-1β from NE.|
1684513|NCT01193049|3097989|Superiority or Other||GM FR from Placebo: SP|0.7||||0.143|2-Sided|90.0|0.4|1.24||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in MIP-1β from SP.|
1684514|NCT01193049|3097990|Superiority or Other||GM FR from Placebo: NE|0.49||||0.036|2-Sided|90.0|0.26|0.93||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) in IL-1β from NE.|
1684515|NCT01193049|3097990|Superiority or Other||GM FR from Placebo: SP|0.6||||0.003|2-Sided|90.0|0.46|0.77||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-1β from SP.|
1684516|NCT01193049|3097991|Superiority or Other||GM FR from Placebo: NE|0.68||||0.103|2-Sided|90.0|0.41|1.14||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from NE.|
1684517|NCT01193049|3097991|Superiority or Other||GM FR from Placebo: SP|0.82||||0.119|2-Sided|90.0|0.62|1.09||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) in IL-17 from SP.|
1684518|NCT01193049|3097992|Superiority or Other||GM FR from Placebo: IL-13|1.35||||0.02|2-Sided|90.0|1.07|1.71||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC(Prednisone)/FC (Placebo) for IL-13.|
1684519|NCT01193049|3097992|Superiority or Other||GM FR from Placebo: IL-5|1.51||||0.01|2-Sided|90.0|1.15|1.99||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) for IL-5.|
1684520|NCT01193049|3097994|Superiority or Other||GM FR from Placebo: NE|0.64||||0.011|2-Sided|90.0|0.47|0.86||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.|
1684521|NCT01193049|3097994|Superiority or Other||GM FR from Placebo:SP|0.61||||0.117|2-Sided|90.0|0.3|1.24||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.|
1684522|NCT01193049|3097995|Superiority or Other||GM FR from Placebo: NE|1.08||||0.681|2-Sided|90.0|0.8|1.46||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from NE.|
1684523|NCT01193049|3097995|Superiority or Other||GM FR from Placebo: SP|0.8||||0.258|2-Sided|90.0|0.43|1.47||1-sided p-value, α = 0.05|ANOVA|||GM FR from Placebo is the GM of individual FC (Prednisone)/FC (Placebo) from SP.|
1684524|NCT01193049|3097996|Superiority or Other||Correlation FR from Placebo: SP vs NE|0.07||||0.83||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FR from placebo in IL-13 after prednisone treatment.|
1684525|NCT01193049|3097996|Superiority or Other||Correlation FC from BL: SP vs NE|-0.02||||0.962||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FC from BL in IL-13 after placebo treatment.|
1684526|NCT01193049|3097996|Superiority or Other||GM FR from Placebo : NE|0.31|||<|0.001|2-Sided|90.0|0.22|0.43||1-sided p-value, α = 0.05|ANOVA|||GM FR is the GM of individual FC Prednisone)/FC(Placebo) from NE.|
1684527|NCT01193049|3097996|Superiority or Other||GM FR from Placebo: SP|0.27|||<|0.009|2-Sided|90.0|0.12|0.62||1-sided p-value, α = 0.05|ANOVA|||GM FR is the GM of individual FC(Prednisone)/FC (Placebo) from SP.|
1684528|NCT01193049|3097997|Superiority or Other||Correlation FR from Placebo :SP vs NE|-0.02||||0.964||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FR from placebo in IL-5 after prednisone treatment.|
1684529|NCT01193049|3097997|Superiority or Other||Correlation FC from BL: SP vs NE|0.2||||0.553||||||Unadjusted for Baseline and Period Effects|Pearson's correlation coefficient|||Correlation between SP and NE of FC from BL in IL-5 after placebo treatment.|
1684530|NCT01193049|3097997|Superiority or Other||GM FR from Placebo : NE|0.2|||<|0.001|2-Sided|90.0|0.13|0.3||1-sided p value, α = 0.05|ANOVA|||GM FR is the GM of individual FC(Prednisone)/FC(Placebo) from NE.|
1684531|NCT01193049|3097997|Superiority or Other||GM FR from Placebo: SP|0.25|||<|0.001|2-Sided|90.0|0.14|0.46||1-sided p-value, α = 0.05|ANOVA|||GM Fold Reduction (FR) is the GM of individual FC(Prednisone)/FC (Placebo) from SP.|
1751224|NCT00330551|3217291|Superiority||||||<|0.16|||||||ANOVA||||
1684536|NCT01192828|3098007|Other|Descriptive analysis||||||0.541|||||||Spearman's rank correlation|||Null hypothesis assumed|Spearman's rank correlation rho is 0.179, with p value 0.541, N is 14
1684537|NCT01192828|3098009|Other|Descriptive analysis.||||||0.014|||||||t-test, 2 sided|paired t-test||Null hypothesis assumed.|
1684538|NCT01192828|3098010|Other|Descriptive analysis.||||||0.052|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.|
1684539|NCT01192828|3098011|Other|Descriptive analysis.||||||0.19|||||||t-test, 2 sided|paired t-test||Null hypothesis applied.|
1684540|NCT01192828|3098012|Other|Descriptive analysis.||||||0.701|||||||t-test, 2 sided|paired||Null hypothesis assumed.|
1684541|NCT01192828|3098013|Other|Descriptive analysis||||||0.235|||||||t-test, 2 sided|paired||Null hypothesis applied.|
1684542|NCT01192776|3098024|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.47|||||2-Sided|95.0|0.13|1.64||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684543|NCT01192776|3098024|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.64|||||2-Sided|95.0|0.3|1.35||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684544|NCT01192776|3098024|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.87|||||2-Sided|95.0|0.37|2.07||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684545|NCT01192776|3098025|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.28|||||2-Sided|95.0|0.03|2.89||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684546|NCT01192776|3098025|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.31|||||2-Sided|95.0|0.44|3.91||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684547|NCT01192776|3098025|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.65|||||2-Sided|95.0|0.14|3.01||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684548|NCT01192776|3098026|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.78|||||2-Sided|95.0|0.2|2.99||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684549|NCT01192776|3098026|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.42|||||2-Sided|95.0|0.09|2.04||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684550|NCT01192776|3098026|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.33|||||2-Sided|95.0|0.63|2.77||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684551|NCT01192776|3098028|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.64|||||2-Sided|95.0|0.26|1.57||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684552|NCT01192776|3098028|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.82|||||2-Sided|95.0|0.36|1.9||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684553|NCT01192776|3098028|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.23|||||2-Sided|95.0|0.64|2.38||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684554|NCT01192776|3098033|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.85|||||2-Sided|95.0|0.79|4.31||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684555|NCT01192776|3098033|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|2.52|||||2-Sided|95.0|1.06|5.95||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684556|NCT01192776|3098033|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|2.16|||||2-Sided|95.0|0.55|8.49||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684557|NCT01192776|3098034|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|0.85|||||2-Sided|95.0|0.53|1.35||||||32.0°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684558|NCT01192776|3098034|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.21|||||2-Sided|95.0|0.78|1.87||||||33.5°C for 120 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684559|NCT01192776|3098034|Superiority|Generalized Estimating Equations models with log link, adjusted for level of encephalopathy and intra-center correlations|Risk Ratio (RR)|1.23|||||2-Sided|95.0|0.76|1.98||||||32.0°C for 72 hours vs. 33.5°C for 72 hours (33.5°C for 72 hours is the comparison group)|
1684560|NCT01192542|3098036|Non-Inferiority or Equivalence|The non-inferiority margin of 0.05 (1/2 LogMAR line) was used.|Least-square mean difference|0.0|Standard Error of the Mean|0.0091|||2-Sided|95.0|-0.018|0.018||||||The alternative hypothesis is the binocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.|
1684561|NCT01192542|3098039|Non-Inferiority or Equivalence|The non-inferiority margin of 0.05 (1/2 LogMAR line) was used.|Least-square mean difference|-0.009|Standard Error of the Mean|0.0064|||2-Sided|95.0|-0.022|0.003|||||The mean difference is calculated as: Test lens - Control lens.|The alternative hypothesis is the monocular visual acuity of the galyfilcon A prototype lens is non-inferior to that of the enfilcon A lens.|
1684879|NCT01185782|3099209|Superiority or Other|||||||0.214|||||||Chi-squared||||
1684564|NCT01192516|3098046|Superiority or Other|||||||0.85|||||||Mixed Models Analysis|Adjusted for age, gender, pain level, and body mass index at baseline.|||
1684565|NCT01192412|3098049|Superiority or Other||Odds Ratio (OR)|1.74|||||2-Sided|95.0|0.79|3.84|||||||
1684566|NCT01192412|3098050|Superiority or Other||Odds Ratio (OR)|1.02|||||2-Sided|95.0|0.77|1.35||||||We estimated that with a sample size of 514 per group, the study would have 80% power, at a two-tailed alpha level of 0.05, assuming primary outcome rates of 33% in the tight-control group and 25% in the less-tight-control group, a 10% rate of crossover, a 1% loss to follow-up, and two interim analyses, as calculated with the chi-square test with the use of East software (Cytel) and the Lan–DeMets spending function with O’Brien–Fleming–type boundaries for early stopping.|
1684567|NCT01192399|3098057|Other||||||<|0.0001|||||||Sign test||||
1684568|NCT01192204|3098091|Superiority or Other|||||||0.16|||||||two-tailed unpaired t test||||
1684569|NCT01192204|3098091|Superiority or Other|||||||0.002|||||||2-tailed unpaired t test||||
1684570|NCT01192204|3098092|Superiority or Other|||||||0.036|||||||Wilcoxon matched-pairs signed rank test||||
1684571|NCT01192204|3098092|Superiority or Other||||||<|0.002|||||||Wilcoxon matched-pairs signed rank test|specifically, we used the Wilcoxon matched-pairs signed rank test.|||
1684572|NCT01192204|3098093|Superiority or Other|||||||0.5||||||Statistical analyses reflect percent change pre versus post histologic grade scores|Wilcoxon matched-pairs signed rank test|||Wilcoxon matched-pairs signed rank test (pre versus post treatment scores)|
1684573|NCT01192204|3098093|Superiority or Other|||||||0.048||||||Statistical analyses reflect percent change intrapatient pre versus post histologic grade scores|Wilcoxon matched-pairs signed rank test|We used a 2-tailed Mann Whitney U test to evaluate these data.||Wilcoxon matched-pairs signed rank test (intrapatient pre versus post treatment scores)|
1684574|NCT01192178|3098111|Superiority or Other||Hazard Ratio (HR)|0.971||||0.928|2-Sided|95.0|0.519|1.819||Cox Proportional Hazards model adjusted for investigative center|Regression, Cox||The risk of having an asthma exacerbation during the treatment period was analyzed.||
1684575|NCT01192152|3098120|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|1151.2||||||95.0||||||||Geometric least squares means for Treatment A|
1684576|NCT01192152|3098120|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|1055.9||||||95.0||||||||Geometric least squares means for Treatment B|
1684577|NCT01192152|3098120|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|ratio of geometric least squares means|0.917|||||2-Sided|90.0|0.859|0.98|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided at least 99% power to conclude BE with respect to Cmax and AUC0-inf.|
1684578|NCT01192152|3098122|Superiority or Other||Geometric least squares mean (ng*hr/mL)|9246.8||||||95.0||||||||Geometric least squares mean for Treatment A|
1684579|NCT01192152|3098122|Superiority or Other||Geometric least squares mean (ng*hr/mL)|8377.8||||||95.0||||||||Geometric least squares means for Treatment B|
1684580|NCT01192152|3098122|Superiority or Other||ratio of geometric least squares means|0.906|||||2-Sided|90.0|0.848|0.968|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.||
1684581|NCT01192152|3098123|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|9746.3||||||95.0||||||||Geometric least squares mean for Treatment A|
1684582|NCT01192152|3098123|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|8713.4||||||95.0||||||||Geometric least squares mean for Treatment B|
1684583|NCT01192152|3098123|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|ratio of geometric least squares means|0.894|||||2-Sided|90.0|0.833|0.959|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided at least 99% power to conclude BE with respect to Cmax and AUC0-inf.|
1684584|NCT01192152|3098140|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|24.88||||||95.0||||||||Geometric least squares means for Treatment A|
1684585|NCT01192152|3098140|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|24.85||||||95.0||||||||Geometric least squares means for Treatment B|
1684586|NCT01192152|3098140|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of geometric least squares mean|0.999|||||2-Sided|90.0|0.948|1.053|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf.|
1684587|NCT01192152|3098142|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|97.72||||||95.0||||||||Geometric least squares means for Treatment A|
1684588|NCT01192152|3098142|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|101.16||||||95.0||||||||Geometric least squares means for Treatment B|
1684589|NCT01192152|3098142|Superiority or Other||Ratio of geometric least squares means|1.035|||||2-Sided|90.0|1.009|1.062|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.||
1684590|NCT01192152|3098143|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|98.61||||||95.0||||||||Geometric least squares means for Treatment A|
1751225|NCT00330551|3217293|Superiority||||||=|0|||||||ANOVA||||
1684591|NCT01192152|3098143|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|103.05||||||95.0||||||||Geometric least squares means for Treatment B|
1684592|NCT01192152|3098143|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of geometric least squares means|1.045|||||2-Sided|90.0|1.025|1.065|||||Ratio = Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a 5-mg saxagliptin tablet plus two 500-mg metformin XR tablets under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf.|
1684593|NCT01192139|3098149|Superiority or Other||Geometric least squares mean (ng*hr/mL)|632.39||||||95.0||||||||Geometric least squares mean for treatment C|
1684594|NCT01192139|3098149|Superiority or Other||Geometric least squares mean (ng*hr/mL)|567.85||||||95.0||||||||Geometric least squares mean for treatment B|
1684595|NCT01192139|3098149|Superiority or Other||Geometric least squares mean (ng*hr/mL)|608.41||||||95.0||||||||Geometric least squares mean for treatment A|
1684596|NCT01192139|3098149|Non-Inferiority or Equivalence|Lack of food effect was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(inf) of saxagliptin and metformin.|Ratio of Geometric Least Squares Means|0.898|||||2-Sided|90.0|0.832|0.969|||||Ration = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.||
1684597|NCT01192139|3098149|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of metformin.|Ratio of Geometric Least Squares Means|0.933|||||2-Sided|95.0|0.865|1.007|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 96% and 97% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1684598|NCT01192139|3098150|Superiority or Other||Geometric least squares mean (ng*hr/mL)|4746.8||||||95.0||||||||Geometric least squares means for treatment C|
1684599|NCT01192139|3098150|Superiority or Other||Geometric least squares mean (ng*hr/mL)|4866.2||||||95.0||||||||Geometric least squares mean for treatment B|
1684600|NCT01192139|3098150|Superiority or Other||Geometric least squares mean (ng*hr/mL)|5287.1||||||95.0||||||||Geometric least squares means for treatment A|
1684601|NCT01192139|3098150|Superiority or Other||Ratio of Geometric Least Squares Means|1.025|||||2-Sided|95.0|0.951|1.105|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.||
1684602|NCT01192139|3098150|Superiority or Other||Ratio of Geometric Least Squares Mean|0.92|||||2-Sided|90.0|0.854|0.992|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.||
1684603|NCT01192139|3098151|Superiority or Other||Geometric least squares mean (ng*hr/mL)|5023.3||||||95.0||||||||Geometric least squares mean for treatment C|
1684604|NCT01192139|3098151|Superiority or Other||Geometric least squares mean (ng*hr/mL)|5072.9||||||95.0||||||||Geometric least squares mean for treatment B|
1684605|NCT01192139|3098151|Superiority or Other||Geometric least squares mean (ng*hr/mL)|5542.2||||||95.0||||||||Geometric least squares means for treatment A|
1684606|NCT01192139|3098151|Non-Inferiority or Equivalence|lack of food effect concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Geometric LS Mean and 90% CI|1.01|||||2-Sided|90.0|0.918|1.111|||||Ratio = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.||
1684607|NCT01192139|3098151|Non-Inferiority or Equivalence|BE concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Least Squares Geometric Means|0.915|||||2-Sided|90.0|0.836|1.002|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 96% and 97% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1684608|NCT01192139|3098160|Superiority or Other||Geometric least squares mean (ng*hr/mL)|27.63||||||95.0||||||||Geometric least squares mean for treatment C|
1684609|NCT01192139|3098160|Superiority or Other||Geometric least squares mean (ng*hr/mL)|26.21||||||95.0||||||||Geometric least squares mean for treatment B|
1684610|NCT01192139|3098160|Superiority or Other||Geometric least squares mean (ng*hr/mL)|25.68||||||95.0||||||||Geometric least squares mean for treatment A|
1684611|NCT01192139|3098160|Non-Inferiority or Equivalence|Lack of food effect was concluded if the fed to fasted ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin.|Ratio of Geometric Least Squares Means|0.949|||||2-Sided|90.0|0.873|1.031|||||Ratio = Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.||
1684612|NCT01192139|3098160|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin.|Ratio of Geometric Least Squares Means|1.021|||||2-Sided|90.0|0.94|1.109|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1684613|NCT01192139|3098161|Superiority or Other||Geometric least squares mean (ng*hr/mL)|98.99||||||95.0||||||||Geometric least squares mean for treatment C|
1684614|NCT01192139|3098161|Superiority or Other||Geometric least squares mean (ng*hr/mL)|106.89||||||95.0||||||||Geometric least squares mean for treatment B|
1684615|NCT01192139|3098161|Superiority or Other||Geometric least squares mean (ng*hr/mL)|102.84||||||95.0||||||||Geometric least squares mean for treatment A|
1684616|NCT01192139|3098161|Superiority or Other||Ratio of Geometric Least Squares Means|1.08|||||2-Sided|90.0|1.051|1.11|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.||
1684617|NCT01192139|3098161|Superiority or Other||Ratio of Geometric Least Squares Mean|1.039|||||2-Sided|90.0|1.011|1.068|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.||
1684618|NCT01192139|3098163|Superiority or Other||Geometric least squares mean (ng*hr/mL)|100.84||||||95.0||||||||Geometric least squares mean for treatment C|
1684619|NCT01192139|3098163|Superiority or Other||Geometric least squares mean (ng*hr/mL)|108.74||||||95.0||||||||Geometric least squares means for treatment B|
1684620|NCT01192139|3098163|Superiority or Other||Geometric least squares mean (ng*hr/mL)|104.65||||||95.0||||||||Geometric least squares means for treatment A|
1684621|NCT01192139|3098163|Non-Inferiority or Equivalence|Lack of food effect was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within (80%, 125%) for both Cmax and AUC(INF) of saxagliptin and metformin.|Ratio of Least Squares Means|1.078|||||2-Sided|90.0|1.049|1.108|||||Ratio=Treatment B/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.||
1684622|NCT01192139|3098163|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios of geometric means were entirely contained within 0.800 to 1.250 for both Cmax and AUC0-inf of saxagliptin|Ratio of Geometric Least Squares Means|1.039|||||2-Sided|90.0|1.011|1.068|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of a saxagliptin tablet and a metformin XR tablet under fed conditions, then 24 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 24 subjects would have provided 94% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1684623|NCT01192022|3098172|Superiority or Other||Odds Ratio (OR)|4.87|Standard Error of the Mean|1.6|<|0.001|2-Sided|95.0|2.55|9.29||Logistic regression model with treatment and pooled center as factors.|Regression, Logistic||||
1684624|NCT01191944|3098175|Superiority or Other||Mean Difference (Final Values)|0.628|Standard Error of the Mean|0.7088||0.376|2-Sided|95.0|-0.765|2.021|||ANCOVA||||
1684625|NCT01191944|3098177|Superiority or Other||Mean Difference (Final Values)|0.154|Standard Error of the Mean|0.3138||0.6237|2-Sided|95.0|-0.463|0.771|||ANCOVA||||
1684626|NCT01191944|3098178|Superiority or Other|||||||0.1051|||||||Cochran-Mantel-Haenszel||||
1684627|NCT01191944|3098179|Superiority or Other|||||||0.4756|||||||Cochran-Mantel-Haenszel||||
1684628|NCT01191944|3098180|Superiority or Other|||||||0.317|||||||Cochran-Mantel-Haenszel||||
1684629|NCT01191944|3098181|Superiority or Other||Mean Difference (Final Values)|0.031|Standard Error of the Mean|0.0798||0.6995|2-Sided|95.0|-0.127|0.188|||ANCOVA||||
1684630|NCT01191944|3098182|Superiority or Other||Mean Difference (Final Values)|0.031|Standard Error of the Mean|0.3727||0.9337|2-Sided|95.0|-0.704|0.766|||ANCOVA||||
1684631|NCT01191944|3098183|Superiority or Other||Mean Difference (Final Values)|0.562|Standard Error of the Mean|0.2509||0.0263|2-Sided|95.0|0.067|1.057|||ANCOVA||||
1684632|NCT01191944|3098184|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.4437||0.2338|2-Sided|95.0|-1.405|0.345|||ANCOVA||||
1684633|NCT01191944|3098185|Superiority or Other||Median Difference (Final Values)|0.369|Standard Error of the Mean|0.4901||0.4529|2-Sided|95.0|-0.598|1.335|||ANCOVA||||
1684634|NCT01191944|3098186|Superiority or Other||Mean Difference (Final Values)|0.621|Standard Error of the Mean|2.2658||0.7843|2-Sided|95.0|-3.848|5.09|||ANCOVA||||
1684635|NCT01191944|3098187|Superiority or Other||Mean Difference (Final Values)|3.51|Standard Error of the Mean|1.5581||0.0254|2-Sided|95.0|0.437|6.583|||ANCOVA||||
1684636|NCT01191944|3098188|Superiority or Other||Median Difference (Final Values)|-2.763|Standard Error of the Mean|2.7845||0.3223|2-Sided|95.0|-8.255|2.729|||ANCOVA||||
1684637|NCT01191944|3098189|Superiority or Other|||||||0.7902|||||||Cochran-Mantel-Haenszel||||
1684638|NCT01191944|3098190|Superiority or Other||Mean Difference (Final Values)|-0.054|Standard Error of the Mean|0.3274||0.8698|2-Sided|95.0|-0.699|0.592|||ANCOVA||||
1684639|NCT01191944|3098191|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|2.1836||0.8261|2-Sided|95.0|-4.787|3.826|||ANCOVA||||
1684640|NCT01191944|3098192|Non-Inferiority or Equivalence|pre-specified non-inferiority (NI) margin of -4 points|Mean Difference (Final Values)|0.76|Standard Error of the Mean|0.9192|<|0.0001||95.0|-1.047|2.566||one-sided test relative to NI margin of -4|ANCOVA|adjusted for treatment, centre and baseline|Pramipexole IR minus Pramipexole ER, Pramipexole ER non inferior to Pramipexole IR if lower limit of confidence interval (CI) for the mean difference is higher than NI margin.|The null hypothesis (H0) states that the mean change from baseline to Week 18 (or last observation carried forward [LOCF]) in the UPDRS II+III score for the treatment group pramipexole ER is inferior to the mean change for the treatment group pramipexole IR.|
1684641|NCT01191801|3098199|Superiority or Other||Hazard Ratio (HR)|0.89||||0.3134|2-Sided|95.0||||One sided P-Value|Log Rank||||
1684642|NCT01191801|3098200|Superiority or Other||Hazard Ratio (HR)|0.67|||<|0.0001|1-Sided|95.0||||Unstratified one-sided P-Value|Log Rank||||
1684643|NCT01191801|3098201|Superiority or Other||||||<|0.0001||||||Two sided P-Value|Chi-squared||||
1684644|NCT01191801|3098204|Superiority or Other||||||<|0.0001||||||Two sided P-Value|Chi-squared||||
1684645|NCT01191801|3098205|Superiority or Other||Cox Proportional Hazard|0.87||||0.0305|1-Sided|95.0||||Unstratified one sided P-Value|Unstratified Log Rank|Since the sample size was increased, the primary analysis used the weighted statistic proposed by Cui, Hung, and Wang (Cui 1999).|||
1684951|NCT01185353|3099284|Superiority or Other||||||<|0.001||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684646|NCT01191736|3098210|Superiority or Other|||||||0.05|||||||Chi-squared|Null hypothesis: the proportions within the seven arms are equal.||Comparison of proportions of subjects who assessed responsiveness|
1684647|NCT01191736|3098211|Superiority or Other|||||||0.05|||||||Kruskal-Wallis|Null hypothesis: the medians for all seven arms are equal.||Kruskal-Wallis test for multiple comparisons|
1684648|NCT01191268|3098252|Superiority or Other||LS Mean Difference|-0.76|||<|0.001|2-Sided|95.0|-1.06|-0.46||Treatment comparison at 52 weeks.|Mixed Models Analysis||||
1684649|NCT01191268|3098252|Superiority or Other||LS Mean Difference|-1.24|||<|0.001|2-Sided|95.0|-1.55|-0.94||Treatment comparison at 52 weeks.|Mixed Models Analysis||||
1684650|NCT01191268|3098252|Superiority or Other||LS Mean Difference|-0.79|||<|0.001|2-Sided|95.0|-1.03|-0.55||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1684651|NCT01191268|3098252|Superiority or Other||LS Mean Difference|-1.2|||<|0.001|2-Sided|95.0|-1.44|-0.96||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1684652|NCT01191268|3098254|Superiority or Other||LS Mean Difference|-2.03|||<|0.001|2-Sided|95.0|-2.78|-1.27||Treatment comparison at 52 weeks.|ANCOVA||||
1684653|NCT01191268|3098254|Superiority or Other||LS Mean Difference|-3.23|||<|0.001|2-Sided|95.0|-3.99|-2.48||Treatment comparison at 52 weeks.|ANCOVA||||
1684654|NCT01191268|3098254|Superiority or Other||LS Mean Difference|-2.15|||<|0.001|2-Sided|95.0|-2.76|-1.54||Treatment comparison at 26 weeks.|ANCOVA||||
1684655|NCT01191268|3098254|Superiority or Other||LS Mean Difference|-3.2|||<|0.001|2-Sided|95.0|-3.81|-2.59||Treatment comparison at 26 weeks.|ANCOVA||||
1684656|NCT01191268|3098256|Superiority or Other||LS Mean Difference|1.42|||<|0.001|2-Sided|95.0|0.88|1.96||Treatment comparison at 52 weeks.|Mixed Models Analysis||||
1684657|NCT01191268|3098256|Superiority or Other||LS Mean Difference|1.09|||<|0.001|2-Sided|95.0|0.55|1.64||Treatment comparison at 52 weeks.|Mixed Models Analysis||||
1684658|NCT01191268|3098256|Superiority or Other||LS Mean Difference|1.8|||<|0.001|2-Sided|95.0|1.32|2.28||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1684659|NCT01191268|3098256|Superiority or Other||LS Mean Difference|1.31|||<|0.001|2-Sided|95.0|0.83|1.79||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1684660|NCT01191268|3098257|Superiority or Other||LS Mean Difference|0.02||||0.879|2-Sided|95.0|-0.26|0.3||Treatment comparison of Daily Mean values at 52 weeks.|Mixed Models Analysis||||
1684661|NCT01191268|3098257|Superiority or Other||LS Mean Difference|0.13||||0.37|2-Sided|95.0|-0.16|0.42||Treatment comparison of Daily Mean values at 52 weeks.|Mixed Models Analysis||||
1684662|NCT01191268|3098257|Superiority or Other||LS Mean Difference|0.13||||0.368|2-Sided|95.0|-0.15|0.41||Treatment comparison of Daily Mean values at 26 weeks.|Mixed Models Analysis||||
1684663|NCT01191268|3098257|Superiority or Other||LS Mean Difference|-0.07||||0.628|2-Sided|95.0|-0.35|0.21||Treatment comparison of Daily Mean values at 26 weeks.|Mixed Models Analysis||||
1684664|NCT01191268|3098258|Superiority or Other||||||<|0.001||||||Treatment comparison at 52 weeks.|Regression, Logistic||||
1684665|NCT01191268|3098258|Superiority or Other||||||<|0.001||||||Treatment comparison at 52 weeks.|Regression, Logistic||||
1684666|NCT01191268|3098258|Superiority or Other||||||<|0.001||||||Treatment comparison at 26 weeks.|Regression, Logistic||||
1684667|NCT01191268|3098258|Superiority or Other||||||<|0.001||||||Treatment comparison at 26 weeks.|Regression, Logistic||||
1684668|NCT01191268|3098259|Superiority or Other|||||||0.623||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic||||
1684669|NCT01191268|3098259|Superiority or Other|||||||0.272||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic||||
1684670|NCT01191268|3098259|Superiority or Other|||||||0.25||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic||||
1684671|NCT01191268|3098259|Superiority or Other||||||<|0.05||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic||||
1684672|NCT01191268|3098259|Superiority or Other||||||<|0.384||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic||||
1684673|NCT01191268|3098259|Superiority or Other||||||<|0.027||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic||||
1684674|NCT01191268|3098259|Superiority or Other||||||<|0.01||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic||||
1684675|NCT01191268|3098259|Superiority or Other||||||<|0.014||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic||||
1684676|NCT01191268|3098260|Superiority or Other||LS Mean Difference|-0.19||||0.014|2-Sided|95.0|-0.37|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.|
1684677|NCT01191268|3098260|Superiority or Other||LS Mean Difference|-0.25||||0.005|2-Sided|95.0|-0.42|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.|
1684678|NCT01191268|3098260|Non-Inferiority or Equivalence|If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.19|||<|0.001|2-Sided|95.0|-0.37|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA||||
1684679|NCT01191268|3098260|Non-Inferiority or Equivalence|If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.25|||<|0.001|2-Sided|95.0|-0.42|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA||||
1684680|NCT01191268|3098261|Superiority or Other||LS Mean Difference|-0.17||||0.015|2-Sided|95.0|-0.33|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.|
1684681|NCT01191268|3098261|Superiority or Other||LS Mean Difference|-0.22||||0.005|2-Sided|95.0|-0.38|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||Superiority analysis.|
1684682|NCT01191268|3098261|Non-Inferiority or Equivalence|If the 1-sided adjusted p-value was below 0.025, then 0.75 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.17|||<|0.001|2-Sided|95.0|-0.33|-0.02||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA||||
1684683|NCT01191268|3098261|Non-Inferiority or Equivalence|If the upper limit of the 95% Confidence Interval (CI) of 1.5 mg LY2189265 versus Insulin Glargine was below 0.4%, 1.5 mg LY2189265 was declared non-inferior to Insulin Glargine.|LS Mean Difference|-0.22|||<|0.001|2-Sided|95.0|-0.38|-0.07||Family-wise Type I error rate was controlled by applying tree-gatekeeping strategy.|ANCOVA|||The study was designed to enroll 837 randomized participants (279 per treatment arm) with 90% power to detect non-inferiority of 1.5 mg LY2189265 versus Insulin Glargine on HbA1c change from baseline at the 26-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 1-sided alpha of 0.025 assuming no true difference between treatments. This corresponds to 248 participants per arm, with an assumed drop-out rate of 11%.|
1684684|NCT01191255|3098262|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1684685|NCT01191255|3098263|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1684686|NCT01191255|3098264|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1684687|NCT01191255|3098265|Superiority or Other||||||<|0.0001||||||The P-value for the change in mean serum Ferritin were created via an ANCOVA model with treatment as the fixed effect and Study-baseline as the co-variate.|ANCOVA||||
1684688|NCT01191255|3098266|Superiority or Other||||||<|0.0001||||||The P-value for the change in mean serum phosphorus was calculated via an ANCOVA model with treatment as the fixed effect and Week-52-baseline as the co-variate.|ANCOVA||||
1684689|NCT01190839|3098298|Superiority or Other|||||||0.098||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test||||
1684690|NCT01190839|3098299|Superiority or Other||||||<|0.001||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test||||
1684691|NCT01190839|3098300|Superiority or Other|||||||0.097||||||p-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by the number of risk factors for recurrence of active CD and baseline use of an immunomodulator.|Cochran-Mantel-Haenszel chi-square test||||
1684692|NCT01190813|3098319|Superiority or Other||Mean Difference (Net)|1.4||||0.06|2-Sided|95.0|-0.4|3.3||The alpha level was set to 0.0485 for the primary analysis to adjust for alpha spending of 0.015 for one interim analysis for efficacy conducted when outcome data were available for 50% of participants.|ANCOVA||Mean difference calculated as Levodopa - Placebo|With 129 participants, assuming a 1-sided type I error rate of 4.85%, there was 96% power to detect a difference in mean visual acuity between treatment groups at 18 weeks adjusted for baseline and for 1 interim analysis for futility if the true difference was 5 letters with SD of 7 letters and 82% power if the true difference was 3.75 letters|
1684693|NCT01190813|3098323|Superiority or Other||Mean Difference (Net)|0.9||||0.17|2-Sided||||||ANCOVA||||
1684694|NCT01190813|3098325|Superiority or Other||Mean Difference (Net)|0.9||||0.2|2-Sided|95.0|-1.2|2.9|||ANCOVA||||
1684695|NCT01190813|3098327|Superiority or Other||Mean Difference (Net)|0.1||||0.44|2-Sided|95.0|-1.6|1.8|||ANCOVA||||
1684696|NCT01190813|3098329|Superiority or Other||Mean Difference (Net)|-0.3||||0.65|2-Sided|95.0|-1.9|1.3|||ANCOVA||Mean difference calculated as Levodopa - Placebo||
1684697|NCT01190813|3098337|Superiority or Other||Percent Difference|-5.0|||||2-Sided|95.0|-22.0|13.0|||||Levodopa - Placebo||
1684698|NCT01190813|3098338|Superiority or Other||Percent Difference|-7.0|||||2-Sided|95.0|-25.0|10.0|||||||
1684699|NCT01190813|3098339|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-17.0|18.0|||||Levodopa - Placebo||
1684700|NCT01190813|3098342|Superiority or Other||Percent Difference|11.0||||0.06|2-Sided|95.0|-7.0|28.0|||Fisher Exact|It was not possible to adjust for baseline VA in these secondary analyses due to the small number of subjects meeting secondary outcome criteria.|Treatment group difference calculated as Levodopa - Placebo|A sample size of 129 participants provided 80% power with 1-sided type I error rate of 5% to reject the hypothesis of no difference between groups if the proportion improved was 30% in the levodopa group compared with 10% in the placebo group.|
1684701|NCT01190514|3098360|Non-Inferiority or Equivalence|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|115.54|||||2-Sided|90.0|108.59|122.94|||||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."|
1684702|NCT01190514|3098360|Non-Inferiority or Equivalence|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|Ratio (%) of adjusted geometric means|101.3|||||2-Sided|90.0|94.66|108.4|||||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg*2 fed (test); DVS SR 50 mg fed (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."|
1684703|NCT01190514|3098360|Non-Inferiority or Equivalence|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for Cmax fell wholly within (80%, 125%).|Ratio (%) of adjusted geometric means|95.1|||||2-Sided|90.0|89.37|101.2|||||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg*2 fasted (test); DVS SR 50 mg fasted (reference).~Natural log transformed Cmax: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."|
1684723|NCT01190254|3098394|Superiority or Other||Odds Ratio (OR)|1.8||||0.048|2-Sided|95.0|1.0|3.3||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of (pooled) site, treatment, and baseline PANSS Total Score|OR was adjusted for baseline and (pooled) site. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total PANSS 30% response||
1684952|NCT01185353|3099284|Superiority or Other||||||<|0.03||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684704|NCT01190514|3098362|Non-Inferiority or Equivalence|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|108.76|||||2-Sided|90.0|101.1|117.01|||||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"Food effect DVS SR 50 mg fed (test) versus DVS SR 50 mg fasted (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."|
1684705|NCT01190514|3098362|Non-Inferiority or Equivalence|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|101.31|||||2-Sided|90.0|97.17|105.64|||||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg*2 fed (test); DVS SR 50 mg fed (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."|
1684706|NCT01190514|3098362|Non-Inferiority or Equivalence|Bioequivalence of the two treatments was to be concluded if the 90% CIs for the ratio of adjusted geometric means for AUC48 fell wholly within (80%, 125%).|ratio (%) of adjusted geometric means|95.56|||||2-Sided|90.0|86.94|105.04|||||Adjusted mean difference and the 90% CI for the difference were exponentiated to provide an estimate of the ratio of adjusted geometric means (test/reference).|"DVS SR 25 mg*2 fasted (test); DVS SR 50 mg fasted (reference).~Natural log transformed AUC48: mixed models analysis with sequence, period, treatment (formulation by food status) as fixed effects and subject within sequence as a random effect."|
1684707|NCT01190254|3098387|Superiority or Other||Difference in LS Means|0.19||||0.111|2-Sided|95.0|-0.04|0.42|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo||
1684708|NCT01190254|3098387|Superiority or Other||Difference in LS Means|0.1||||0.407|2-Sided|95.0|-0.13|0.33|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo||
1684709|NCT01190254|3098388|Superiority or Other||Difference in LS Means|2.1||||0.064|2-Sided|95.0|-0.1|4.3|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo||
1684710|NCT01190254|3098388|Superiority or Other||Difference in LS Means|0.6||||0.6|2-Sided|95.0|-1.6|2.8|||ANCOVA|Model included terms of (pooled) site, treatment, and baseline|Estimate is asenapine versus placebo||
1684711|NCT01190254|3098389|Superiority or Other||Difference in LS Means|4.2||||0.017|2-Sided|95.0|0.8|7.6|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684712|NCT01190254|3098389|Superiority or Other||Difference in LS Means|1.4||||0.417|2-Sided|95.0|-2.0|4.8|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684713|NCT01190254|3098390|Superiority or Other||Hazard Ratio (HR)|1.8||||0.01|2-Sided|95.0|1.2|2.9|||Regression, Cox|Model included factors for (pooled) site and treatment|An HR of >1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo||
1684714|NCT01190254|3098390|Superiority or Other||Hazard Ratio (HR)|1.4||||0.135|2-Sided|95.0|0.9|2.3|||Regression, Cox|Model included factors for (pooled) site and treatment|An HR of >1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo||
1684715|NCT01190254|3098390|Superiority or Other|||||||0.057||||||p-value is for Log Rank test of difference in time to event (CGI-I response) curves between the three treatment groups|Log Rank||||
1684716|NCT01190254|3098391|Superiority or Other||Odds Ratio (OR)|1.6||||0.114|2-Sided|95.0|0.9|2.9||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of region (Asia-Pacific, North America, Eastern Europe [Africa/Latin America sites assigned to this region]) and treatment|OR was adjusted for region. An OR of >1 is considered to mean that asenapine has a higher probability of achieving CGI-I response||
1684717|NCT01190254|3098391|Superiority or Other||Odds Ratio (OR)|1.5||||0.177|2-Sided|95.0|0.8|2.8||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of region (Asia-Pacific, North America, Eastern Europe [Africa/Latin America sites assigned to this region]) and treatment|OR was adjusted for region. An OR of >1 is considered to mean that asenapine has a higher probability of achieving CGI-I response||
1684718|NCT01190254|3098392|Superiority or Other||Difference in LS Means|-0.5||||0.003|2-Sided|95.0|-0.8|-0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, and the interaction of visit by treatment|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684719|NCT01190254|3098392|Superiority or Other||Difference in LS Means|-0.3||||0.094|2-Sided|95.0|-0.6|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, and the interaction of visit by treatment|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684720|NCT01190254|3098393|Superiority or Other||Hazard Ratio (HR)|1.2||||0.368|2-Sided|95.0|0.8|1.8|||Regression, Cox|Model included factors for (pooled) site, treatment and baseline PANSS Total Score|An HR of >1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo||
1684721|NCT01190254|3098393|Superiority or Other||Hazard Ratio (HR)|1.3||||0.171|2-Sided|95.0|0.9|2.0|||Regression, Cox|Model included factors for (pooled) site, treatment and baseline PANSS Total Score|An HR of >1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo||
1684722|NCT01190254|3098393|Superiority or Other|||||||0.576||||||p-value is for Log Rank test of difference in time to event (PANSS 30% response) curves between the three treatment groups|Log Rank||||
1684768|NCT01189500|3098566|Superiority or Other||ratio of adjusted means|108.47|||||2-Sided|90.0|103.51|113.67|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)|
1684724|NCT01190254|3098394|Superiority or Other||Odds Ratio (OR)|2.0||||0.028|2-Sided|95.0|1.1|3.6||95% Confidence Interval and p-value are based on Wald statistic|Regression, Logistic|Model included terms of (pooled) site, treatment, and baseline PANSS Total Score|OR was adjusted for baseline and (pooled) site. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total PANSS 30% response||
1684725|NCT01190254|3098395|Superiority or Other||Difference in LS Means|-0.5||||0.146|2-Sided|95.0|-1.3|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684726|NCT01190254|3098395|Superiority or Other||Difference in LS Means|-0.4||||0.263|2-Sided|95.0|-1.2|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684727|NCT01190254|3098396|Superiority or Other||Difference in LS Means|-0.8||||0.12|2-Sided|95.0|-1.9|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684728|NCT01190254|3098396|Superiority or Other||Difference in LS Means|-1.0||||0.071|2-Sided|95.0|-2.0|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684729|NCT01190254|3098397|Superiority or Other||Difference in LS Means|-0.9||||0.135|2-Sided|95.0|-2.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684730|NCT01190254|3098397|Superiority or Other||Difference in LS Means|-0.9||||0.131|2-Sided|95.0|-2.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684731|NCT01190254|3098398|Superiority or Other||Difference in LS Means|-1.3||||0.067|2-Sided|95.0|-2.7|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684732|NCT01190254|3098398|Superiority or Other||Difference in LS Means|-1.2||||0.083|2-Sided|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684733|NCT01190254|3098399|Superiority or Other||Difference in LS Means|-1.9||||0.026|2-Sided|95.0|-3.6|-0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684734|NCT01190254|3098399|Superiority or Other||Difference in LS Means|-1.4||||0.106|2-Sided|95.0|-3.1|0.3|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684735|NCT01190254|3098400|Superiority or Other||Difference in LS Means|-2.3||||0.071|2-Sided|95.0|-4.8|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684736|NCT01190254|3098400|Superiority or Other||Difference in LS Means|-2.1||||0.098|2-Sided|95.0|-4.6|0.4|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684737|NCT01190254|3098401|Superiority or Other||Difference in LS Means|-3.2||||0.025|2-Sided|95.0|-6.0|-0.4|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684738|NCT01190254|3098401|Superiority or Other||Difference in LS Means|-2.7||||0.062|2-Sided|95.0|-5.6|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684739|NCT01190254|3098402|Superiority or Other||Difference in LS Means|-1.2||||0.099|2-Sided|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684740|NCT01190254|3098402|Superiority or Other||Difference in LS Means|-1.2||||0.097|2-Sided|95.0|-2.6|0.2|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684741|NCT01190254|3098403|Superiority or Other||Difference in LS Means|-2.1||||0.012|2-Sided|95.0|-3.8|-0.5|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684742|NCT01190254|3098403|Superiority or Other||Difference in LS Means|-1.6||||0.067|2-Sided|95.0|-3.3|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684743|NCT01190254|3098404|Superiority or Other||Difference in LS Means|-0.3||||0.024||95.0|-0.6|0.0|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Confirmative testing for the key secondary endpoint was to be performed only if both asenapine doses were superior to placebo in change from baseline in PANSS total score at Day 56 (hypotheses associated with Primary outcome measure). If this did not occur, no confirmative testing could be performed and multiplicity unadjusted p-values are provided. Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684744|NCT01190254|3098404|Superiority or Other||Difference in LS Means|-0.2||||0.218|2-Sided|95.0|-0.5|0.1|||MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Confirmative testing for the key secondary endpoint was to be performed only if both asenapine doses were superior to placebo in change from baseline in PANSS total score at Day 56 (hypotheses associated with Primary outcome measure). If this did not occur, no confirmative testing could be performed and multiplicity unadjusted p-values are provided. Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684745|NCT01190254|3098405|Superiority or Other|||||||0.273||||||p-value (adjusted to control Type I error in multiple testing) for Concave dose-response pattern (Placebo=2.5 mg<5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)|
1684746|NCT01190254|3098405|Superiority or Other|||||||0.046||||||p-value (adjusted to control Type I error in multiple testing) for Convex dose-response pattern (Placebo<2.5 mg=5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)|
1684747|NCT01190254|3098405|Superiority or Other|||||||0.064||||||p-value (adjusted to control Type I error in multiple testing) for Linear dose-response pattern (Placebo<2.5 mg<5.0 mg)|MMRM|||Investigation of dose-response relationship of change from baseline to Day 56 in PANSS Total Score was a Secondary study endpoint. Multiple contrast testing using MMRM model was used to evaluate 3 pre-defined dose-response patterns (Linear, Convex, Concave)|
1684748|NCT01190254|3098405|Superiority or Other||Difference in LS Means|-5.6||||0.064|2-Sided|95.0|-10.7|-0.5||p-value is adjusted by Hochberg's method for testing two asenapine groups versus the placebo group|MMRM|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684749|NCT01190254|3098405|Superiority or Other||Difference in Least Squares (LS) Means|-4.8||||0.07|2-Sided|95.0|-9.9|0.4||p-value is adjusted by Hochberg's method for testing two asenapine groups versus the placebo group|Mixed Model for Repeated Measures (MMRM)|Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit|Estimate is asenapine versus placebo|Model uses efficacy FAS population (number of participants: placebo – 100, asenapine 2.5 mg – 96, asenapine – 104)|
1684750|NCT01190124|3098478|Superiority or Other|||||||0.001|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 48|
1684751|NCT01190124|3098479|Superiority or Other|||||||0.007|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at week 24|
1684752|NCT01190124|3098492|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning CD4 cells count at baseline|
1684753|NCT01190124|3098495|Superiority or Other||||||<|0.001|||||||Chi-squared|||Comparison between the 3 study groups, in order to determine if there are statistically significant differences concerning HIV-RNA levels at baseline|
1684754|NCT01190098|3098496|Superiority or Other||Mean Difference (Net)|-0.2||||0.95|2-Sided||||||t-test, 2 sided||||
1684755|NCT01190098|3098497|Superiority or Other||Median Difference (Net)|0.0||||0.69|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1684756|NCT01190098|3098498|Superiority or Other||Mean Difference (Net)|0.1||||0.92|2-Sided||||||t-test, 2 sided||||
1684757|NCT01190098|3098499|Superiority or Other||Mean Difference (Net)|4.8||||0.33|2-Sided||||||t-test, 2 sided||||
1684758|NCT01190098|3098500|Superiority or Other||Mean Difference (Net)|-0.8||||0.37|2-Sided||||||t-test, 2 sided||||
1684759|NCT01190098|3098501|Superiority or Other||Mean Difference (Net)|-0.3||||0.84|2-Sided||||||t-test, 2 sided||||
1684760|NCT01190098|3098502|Superiority or Other||Mean Difference (Net)|5.7||||0.23|2-Sided||||||t-test, 2 sided||||
1684761|NCT01190098|3098503|Non-Inferiority or Equivalence|Null hypothesis: there is a non-inferiority region of 4 points.||||||0.027|||||||t-test, 1 sided||||
1684762|NCT01189890|3098523|Superiority or Other||Difference in LS Means|-0.7||||0.011|2-Sided|95.0|-1.3|-0.2|||ANCOVA|Controlled for treatment, eGFR stratum, age stratum, and baseline body weight.|||
1684763|NCT01189890|3098524|Superiority or Other||Relative Risk|0.4|||||2-Sided|95.0|0.3|0.7|||||||
1684764|NCT01189890|3098525|Superiority or Other||Relative Risk|0.7|||||2-Sided|95.0|0.6|0.9|||||||
1684765|NCT01189890|3098526|Superiority or Other||Difference in LS Means|6.7|||||2-Sided|95.0|0.7|12.7|||||||
1684766|NCT01189890|3098529|Superiority or Other||Difference in Percent Incidence|-3.9||||0.009|2-Sided|95.0|-7.5|-1.2|||Miettinen & Nurminen|Stratified by estimated glomerular filtration rate (eGFR) stratum and age stratum.|||
1684767|NCT01189890|3098530|Non-Inferiority or Equivalence|The predefined non-inferiority margin was 0.4%.|Difference in LS Means|0.19|||||2-Sided|95.0|0.03|0.34|||||||
1684769|NCT01189500|3098567|Superiority or Other||ratio of adjusted means|105.6|||||2-Sided|90.0|99.74|111.81|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)|
1684770|NCT01189500|3098572|Superiority or Other||ratio of adjusted means|112.07|||||2-Sided|90.0|107.44|116.9|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)|
1684771|NCT01189500|3098578|Superiority or Other||ratio of adjusted means|92.04|||||2-Sided|90.0|84.71|100.0|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)|
1684772|NCT01189500|3098583|Superiority or Other||ratio of adjusted means|99.44|||||2-Sided|90.0|94.02|105.17|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)|
1684773|NCT01189500|3098585|Superiority or Other||ratio of adjusted means|100.69|||||2-Sided|90.0|96.7|104.85|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Tamoxifen 40 mg (test) versus Tamoxifen 40 mg (reference)|
1684774|NCT01189292|3098604|Superiority or Other|||||||0.835|||||||Wilcoxon (Mann-Whitney)||||
1684775|NCT01189292|3098605|Superiority or Other|||||||0.674|||||||Mixed Models Analysis|mixed model over the mean ranks at all time points measured (4, 8, 16, 24, 32, 48 hours)|||
1684776|NCT01189292|3098608|Superiority or Other||Risk Difference (RD)|24.0||||0.006|2-Sided|95.0|7.0|40.0|||Chi-squared|||per protocol analysis|
1684777|NCT01189292|3098609|Superiority or Other||Risk Difference (RD)|28.0||||0.001|2-Sided|95.0|12.0|42.0|||Chi-squared|||null hypothesis: Incidence of PONV is the same in both treatment arms|
1684778|NCT01189201|3098636|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|96.36|Standard Deviation|14.3|||2-Sided|90.0|89.78|103.42|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684779|NCT01189201|3098637|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|103.71|Standard Deviation|22.4|||2-Sided|90.0|92.93|115.74|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684780|NCT01189201|3098638|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|92.98|Standard Deviation|14.9|||2-Sided|90.0|86.36|100.09|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684781|NCT01189201|3098639|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|95.69|Standard Deviation|9.8|||2-Sided|90.0|91.17|100.43|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684782|NCT01189201|3098640|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|98.04|Standard Deviation|13.0|||2-Sided|90.0|91.95|104.53|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684783|NCT01189201|3098641|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A3 (fasted)|Geometric Mean Ratio|95.64|Standard Deviation|9.6|||2-Sided|90.0|91.19|100.3|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684784|NCT01189201|3098642|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|90.95|Standard Deviation|13.2|||2-Sided|90.0|84.24|98.19|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684785|NCT01189201|3098643|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|68.48|Standard Deviation|27.2|||2-Sided|90.0|58.59|80.03|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684786|NCT01189201|3098644|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|93.18|Standard Deviation|15.7|||2-Sided|90.0|85.07|102.05|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684787|NCT01189201|3098645|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|85.32|Standard Deviation|9.4|||2-Sided|90.0|80.77|90.14|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684788|NCT01189201|3098646|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|61.41|Standard Deviation|22.0|||2-Sided|90.0|54.1|69.71|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684789|NCT01189201|3098647|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin FDC A1 (fed)|Geometric Mean Ratio|85.86|Standard Deviation|9.3|||2-Sided|90.0|81.33|90.64|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684790|NCT01189201|3098648|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.64|Standard Deviation|19.7|||2-Sided|90.0|97.23|112.62|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684791|NCT01189201|3098649|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.78|Standard Deviation|7.1|||2-Sided|90.0|102.02|107.61|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684792|NCT01189201|3098652|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|109.68|Standard Deviation|26.2|||2-Sided|90.0|99.55|120.83|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684911|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|1.32|||<|0.265|2-Sided|95.0|0.81|2.13|||Univariate logistic regression model|||Comparison between number of participants without anemia and number of participants with anemia|
1684793|NCT01189201|3098653|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|107.68|Standard Deviation|15.3|||2-Sided|90.0|101.7|114.02|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684794|NCT01189201|3098654|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.91|Standard Deviation|12.8|||2-Sided|90.0|99.97|110.09|||||Standard deviation is actually the gCV|No formal testing, investigation of relative bioavailability|
1684795|NCT01189201|3098655|Non-Inferiority or Equivalence|Ratio calculated as empa plus linagliptin FDC A1 (fasted) divided by empa plus linagliptin individual tablets (fasted)|Geometric Mean Ratio|104.9|Standard Deviation|7.2|||2-Sided|90.0|102.07|107.8|||||Standard deviation is actually the geometric coefficient of variation (gCV)|No formal testing, investigation of relative bioavailability|
1684796|NCT01189110|3098662|Superiority or Other||Odds Ratio (OR)|0.81|Standard Error of the Mean|0.42||0.74|2-Sided|95.0|0.23|2.83|||Chi-squared|||A two-proportion z-test was used to compare the proportion of self-reported abstinence at 3 weeks between groups.|
1684797|NCT01189032|3098665|Superiority or Other|||||||0.006||||||It’s the p-value of Saturated at 1% DE–089. It’s adjusted for multiplicity.|maximum contrast method|To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).|||
1684798|NCT01189032|3098665|Superiority or Other|||||||0.004||||||It’s the p-value of linear trend. It’s adjusted for multiplicity.|maximum contrast method|To confirm dose-response relation, two contrasts were provided; linear trend (-1, 0, 1), and saturated at 1% DE-089 ophthalmic solution (-2, 1, 1).|||
1684799|NCT01188668|3098709|Superiority or Other||ratio of adjusted means|106.27|||||2-Sided|90.0|100.97|111.85|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)|
1684800|NCT01188668|3098710|Superiority or Other||ratio of adjusted means|102.93|||||2-Sided|90.0|94.21|112.46|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)|
1684801|NCT01188668|3098715|Superiority or Other||ratio of adjusted means|101.05|||||2-Sided|90.0|92.94|109.87|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)|
1684802|NCT01188668|3098716|Superiority or Other||ratio of adjusted means|105.97|||||2-Sided|90.0|101.39|110.76|||||Values have been back-transformed from the log scale.|DVS SR 100 mg + Aripiprazole 5 mg (test) versus Aripiprazole 5 mg (reference)|
1684803|NCT01188499|3098747|Superiority or Other||Percent|10.0|||||2-Sided||||||||Percent patients overall across all five arms demonstrating complete or partial response by RECIST. No formal statistics performed.||
1684804|NCT01188499|3098748|Superiority or Other||Percent|100.0|||||2-Sided||||||||Primary objective of safety and tolerability measured by percent participants experiencing at least one adverse event. No formal statistics performed.||
1684805|NCT01188421|3098765|Superiority||F-value for the main effect of Group x P|2.03||||0.092|2-Sided|||||Main effect for Group x Phase interaction on COWS Total Score|ANOVA||||
1684806|NCT01188421|3098765|Superiority||F-value for main effect of Phase|3.57||||0.03|2-Sided|||||Main effect for Phase (e.g., Stabilization, Taper, Post-Taper) on COWS total score.|ANOVA||||
1684807|NCT01188421|3098765|Superiority||F-value for main effect of Group|1.31||||0.275|2-Sided|||||Main effect of Group (e.g., Buprenorphine, Tramadol, Clonidine) on COWS Total Score Ratings|ANOVA|||A power analysis determined 40 participants in each group would detect a moderate effect size, assuming an alpha of 0.05 and 80% power. Due to the expiration of buprenorphine tablets, recruitment was terminated after enrolling 103 participants. This study utilized an Intent-to-Treat (ITT) analysis. The ITT analysis includes all volunteers who signed informed consent, were randomized into the study's treatment conditions, and took at least 1 dose of study medication.|
1684808|NCT01187953|3098869|Non-Inferiority or Equivalence|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.383||||||Endpoint: Lost to follow up|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.|
1684809|NCT01187953|3098869|Non-Inferiority or Equivalence|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.822||||||Endpoint: BPAR|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.|
1684810|NCT01187953|3098869|Non-Inferiority or Equivalence|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.548||||||Endpoint: Graft Failure|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.|
1684811|NCT01187953|3098869|Non-Inferiority or Equivalence|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.||||||0.835||||||Endpoint: Death|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.|
1684840|NCT01187498|3098951|Superiority or Other||Difference of Group Means|0.19|Standard Error of the Mean|0.091||0.05||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values|
1751226|NCT00330551|3217294|Superiority|||||||0.71|||||||ANOVA||||
1684812|NCT01187953|3098870|Non-Inferiority or Equivalence|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.999||||||Endpoint: Lost to follow up|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.|
1684813|NCT01187953|3098870|Non-Inferiority or Equivalence|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.9||||||Endpoint: BPAR|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.|
1684814|NCT01187953|3098870|Non-Inferiority or Equivalence|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.821||||||Endpoint: Graft Failure|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.|
1684815|NCT01187953|3098870|Non-Inferiority or Equivalence|It was assumed that both treatment groups in this study would have a 15% 12-month treatment failure rate, the study will require 270 patients per group to have 90% power to reject the null hypothesis that the investigational drug, LCP-tacro, is inferior to the reference drug, Prograf, based on a 2-sided 95% CI for the difference and a 0.10 non-inferiority margin.|||||>|0.999||||||Endpoint: Death|Fisher Exact|||No overall p value was calculated, only individual p values for each endpoint category. One statistical analysis table is reported for each individual p value.|
1684816|NCT01187914|3098871|Superiority or Other||Regression coefficient|0.13||||0.48||95.0|||||Regression, Linear||||
1684817|NCT01187901|3098872|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1684818|NCT01187901|3098873|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1684819|NCT01187901|3098874|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1684820|NCT01187901|3098875|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1684821|NCT01187901|3098876|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1684822|NCT01187901|3098877|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1684823|NCT01187550|3098886|Superiority or Other|||||||0.091|||||||Wilcoxon rank sum test|||For triglycerides: Wilcoxon rank sum test was used to calculate p-value.|
1684824|NCT01187550|3098886|Superiority or Other|||||||0.041|||||||Wilcoxon rank sum test|||For LDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.|
1684825|NCT01187550|3098886|Superiority or Other|||||||0.033|||||||Wilcoxon rank sum test|||For HDL-cholesterol: Wilcoxon rank sum test was used to calculate p-value.|
1684826|NCT01187550|3098886|Superiority or Other|||||||0.078|||||||Wilcoxon rank sum test|||For total cholesterol: Wilcoxon rank sum test was used to calculate p-value.|
1684827|NCT01187550|3098887|Superiority or Other|||||||0.308|||||||Wilcoxon rank sum test||||
1684828|NCT01187550|3098888|Superiority or Other|||||||0.265|||||||Wilcoxon rank sum test||||
1684829|NCT01187550|3098889|Superiority or Other|||||||0.71|||||||Wilcoxon rank sum test||||
1684830|NCT01187550|3098890|Superiority or Other|||||||0.752|||||||Wilcoxon rank sum test||||
1684831|NCT01187550|3098891|Superiority or Other|||||||0.194|||||||Wilcoxon rank sum test||||
1684832|NCT01187498|3098943|Superiority or Other||Difference in Group Proportions|-0.21|Standard Error of the Mean|0.086||0.02||95.0|||||Chi-squared||The estimated parameter of dispersion represents the standard error for the difference of the group proportions.|Cochran Mantel-Haenszel procedure.|
1684833|NCT01187498|3098944|Superiority or Other|||||||0.01|||||||Cochran-Mantel-Haenszel|||Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.|
1684834|NCT01187498|3098945|Superiority or Other||Difference in Weighted Group Means|0.054|Standard Error of the Mean|0.1265||0.65||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.|
1684835|NCT01187498|3098946|Superiority or Other||Difference in Weighted Group Means|0.1079|Standard Error of the Mean|0.1625||0.56||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.|
1684836|NCT01187498|3098947|Superiority or Other||Difference between Group Weighted Means|-0.1563|Standard Error of the Mean|0.1009||0.16||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.|
1684837|NCT01187498|3098948|Superiority or Other||Difference in Weighted Group Means|-0.0563|Standard Error of the Mean|0.1249||0.69||95.0|||||Cochran-Mantel-Haenszel||The estimated parameter of dispersion represents the standard error for the difference of the weighted group means.|Cochran Mantel-Haenszel procedure used to account for the ordinal nature of responses.|
1684838|NCT01187498|3098949|Superiority or Other||Median Difference (Net)|0.2|Standard Error of the Mean|0.924||0.84||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values|
1684839|NCT01187498|3098950|Superiority or Other||Difference in Group Means|-0.14|Standard Error of the Mean|0.091||0.33||95.0|||||t-test, 2 sided||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values|
1684874|NCT01185782|3099204|Superiority or Other|||||||0.56|||||||Chi-squared||||
1684875|NCT01185782|3099205|Superiority or Other|||||||0.102|||||||Chi-squared||||
1684841|NCT01187498|3098952|Superiority or Other||Difference of the Means|-0.38|Standard Error of the Mean|0.188||0.05||95.0|||||Regression, Linear||The estimated parameter of dispersion represents the standard error for the difference of the group means.|Standard regression methods adjusting for baseline values|
1684842|NCT01187498|3098953|Non-Inferiority or Equivalence|A power analysis indicated that a sample size of 70 per group would provide 80% power with a one-sided alpha of 0.05 to declare two means equivalent, assuming a mean voiding frequency of 8.2 for behavioral treatment, a mean voiding frequency of 8.0 for drug therapy, and a standard deviation of 2.3 for both groups. Equivalence was defined as ±15% of the drug therapy posttreatment mean.|Difference of the Means|0.4|Standard Error of the Mean|0.346||0.001||95.0|||||Regression, Linear||The estimated parameter of dispersion is the standard error of the regression coefficient which measured the adjusted difference of the group means.|The primary analysis was an equivalence analysis to compare the two treatment groups on posttreatment 24- hour voiding frequency using a margin of ±15% of the drug group mean. Schuirmann’s two one-sided tests (TOST) approach was used first to examine completers and then repeated using last observation carried forward to include participants who did not complete therapy. Adjusting the test to regression, the analyses were repeated using baseline voiding frequency as a covariate.|
1684843|NCT01187407|3098989|Superiority or Other|||||||0.769||||||Secondary comparison.|Mixed Models Analysis||||
1684844|NCT01187407|3098989|Superiority or Other|||||||0.997||||||Primary comparison.|Mixed Models Analysis||||
1684845|NCT01187329|3099000|Superiority||Mean Difference (Final Values)|-0.1||||0.45|2-Sided|95.0|-0.2|0.1|||t-test, 2 sided||||
1684846|NCT01187329|3099001|Superiority||Median Difference (Final Values)|-0.6||||0.57|2-Sided|95.0|-2.6|1.5|||t-test, 2 sided||||
1684847|NCT01187329|3099002|Superiority||Mean Difference (Final Values)|-0.2||||0.007|2-Sided|97.5|-0.3|-0.01|||t-test, 2 sided|paired t-test|||
1684848|NCT01187329|3099003|Superiority||Mean Difference (Final Values)|-1.2||||0.11|2-Sided|97.5|-2.87|0.48|||t-test, 2 sided||||
1684849|NCT01187004|3099007|Superiority or Other||Median Difference (Final Values)|1.199|||<|0.001|2-Sided|95.0|1.129|1.272|||Wilcoxon (Mann-Whitney)||||
1684850|NCT01187004|3099008|Superiority or Other||Odds Ratio (OR)|1.0|||<|0.05|2-Sided|95.0|||||Regression, Logistic|significant level for inclusion at the univariate analysis was p<0.05.||Our hypothesis was that mechanical ventilation with large tidal volume might represent a risk factor for acute lung injury in patients undergoing cardiopulmonary bypass.|
1684851|NCT01186796|3099013|Superiority or Other||||||<|0.05|||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.|||
1684852|NCT01186796|3099014|Superiority or Other||||||<|0.05|||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.|||
1684853|NCT01186796|3099015|Superiority or Other||||||<|0.05||||||"Unit of mass secreted per burst is in ug/L. An automated deconvolution method was used and mathematically verified by direct statistical proof and empirically validated using hypothalamopituitary sampling and a simulated pulsatile time series."|ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.|||
1684854|NCT01186796|3099016|Superiority or Other||||||<|0.05|||||||ANOVA|Two-way ANOVA in a 2x4 factorial nested design with repeated measures.|||
1684855|NCT01186796|3099017|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1684856|NCT01186770|3099018|Superiority||LS mean difference|0.53||||0.0237|2-Sided|95.0|0.07|0.98||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.|
1684857|NCT01186770|3099018|Superiority||LS mean difference|0.51||||0.0274|2-Sided|95.0|0.06|0.97||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.|
1684858|NCT01186770|3099018|Superiority||LS mean difference|0.09||||0.692|2-Sided|95.0|-0.36|0.55||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA model with treatment as effect and analysis region and baseline as covariates.|
1684859|NCT01186770|3099019|Superiority||Odds Ratio (OR)|1.79||||0.0043||95.0|1.2|2.66||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.|
1684860|NCT01186770|3099019|Superiority||Odds Ratio (OR)|1.54||||0.0339|2-Sided|95.0|1.03|2.29||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.|
1684861|NCT01186770|3099019|Superiority||Odds Ratio (OR)|1.23||||0.3076|2-Sided|95.0|0.82|1.84||Threshold for significance at 0.0167 level.|Regression, Logistic|||Analysis was performed using logistic regression model with treatment as effect and analysis region as covariate.|
1684862|NCT01186770|3099020|Superiority||LS mean difference|9.13|||<|0.0001|2-Sided|95.0|5.09|13.18||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA with treatment as effect and analysis region as covariate.|
1684863|NCT01186770|3099020|Superiority||LS mean difference|6.51|||<|0.0016|2-Sided|95.0|2.47|10.55||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using ANCOVA with treatment as effect and analysis region as covariate.|
1684864|NCT01186770|3099020|Superiority||Least square (LS) mean difference|2.83|||<|0.1692||95.0|-1.21|6.86||Threshold for significance at 0.0167 level.|ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) with treatment as effect and analysis region as covariate.|
1684865|NCT01186744|3099144|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1684866|NCT01186744|3099144|Superiority or Other||||||<|0.0027|||||||Log Rank||||
1684867|NCT01186744|3099145|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1684868|NCT01186744|3099145|Superiority or Other||||||<|0.0008|||||||Log Rank||||
1684869|NCT01186419|3099164|Superiority or Other|||||||0.0765|||||||t-test, 2 sided||||
1684870|NCT01185964|3099185|Superiority or Other||Hazard Ratio (HR)|0.463||||0.0003|2-Sided|95.0|0.301|0.71|||Log Rank||||
1684871|NCT01185964|3099188|Superiority or Other||Hazard Ratio (HR)|0.672||||0.0615|2-Sided|95.0|0.442|1.021|||Log Rank||||
1684872|NCT01185782|3099202|Superiority or Other|||||||0.416|||||||Chi-squared||||
1684873|NCT01185782|3099203|Superiority or Other|||||||0.555|||||||Chi-squared||||
1684880|NCT01185782|3099210|Non-Inferiority or Equivalence|"The primary endpoint was to determine whether or not SJ-0021 is inferior to u-hFSH in inducing ovulation. The criterion for non-inferiority was that the lower limit of the two-sided 95% CI (= one-sided 97.5% CI) had to be greater than -15% for SJ-0021 to be considered not inferior to u-hFSH.)"|Delta|-3.51|||||2-Sided|95.0|-13.05|6.04|||||||
1684881|NCT01185600|3099231|Superiority or Other||Negative Binomial|1.64||||0.0176|2-Sided|95.0|1.06|2.55|||t-test, 2 sided||"Using Negative Binomial Regression the following ratio and corresponding 95% CI were obtained:~(# of AE’s, Unwashed Group / (# of AE’s, Washed Group) = 1.64 95% C.I. = [1.06 – 2.55]"||
1684882|NCT01185600|3099232|Superiority or Other|||||||0.7205|||||||t-test, 1 sided||||
1684883|NCT01185600|3099233|Superiority or Other|||||||0.1739|||||||t-test, 2 sided||||
1684884|NCT01185600|3099234|Superiority or Other|||||||0.0964|||||||t-test, 2 sided||||
1684885|NCT01185600|3099235|Superiority or Other|||||||0.1007|||||||t-test, 2 sided||||
1684886|NCT01185600|3099236|Superiority or Other|||||||0.372|||||||Fisher Exact||||
1684887|NCT01185600|3099237|Superiority or Other|||||||0.0391|||||||Fisher Exact||||
1684888|NCT01185600|3099238|Superiority or Other|||||||0.142|||||||Fisher Exact||||
1684889|NCT01185561|3099239|Superiority or Other||Mean Difference (Final Values)|0.73|Standard Error of the Mean|3.75||0.85|2-Sided|95.0|-6.77|8.24|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Trait Anger Expression Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.|
1684890|NCT01185561|3099240|Superiority or Other||Mean Difference (Final Values)|8.48|Standard Error of the Mean|2.91||0.005|2-Sided|95.0|2.64|14.31|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Trait Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.|
1684891|NCT01185561|3099241|Superiority or Other||Mean Difference (Final Values)|7.82|Standard Error of the Mean|3.27||0.02|2-Sided|95.0|1.29|14.37|||t-test, 2 sided|||The null hypothesis is that there is no difference in the State Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.|
1684892|NCT01185561|3099242|Superiority or Other||Mean Difference (Final Values)|8.89|Standard Error of the Mean|2.43||0.001|2-Sided|95.0|4.03|13.76|||t-test, 2 sided|||The null hypothesis is that there is no difference in CES-D score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.|
1684893|NCT01185522|3099258|Superiority or Other||Odds Ratio (OR)|1.05||||0.021|2-Sided|95.0|1.01|1.09|||Univariate logistic regression model|||Predictive factor : Swollen joint|
1684894|NCT01185522|3099258|Superiority or Other||Odds Ratio (OR)|1.02||||0.253|2-Sided|95.0|0.99|1.05|||Univariate logistic regression model|||Predictive factor: Tender joint|
1684895|NCT01185522|3099259|Superiority or Other||Odds Ratio (OR)|1.14||||0.013|2-Sided|95.0|1.03|1.27|||Multivariate logistic regression model|||Predictive factor: C-Reactive Protein|
1684896|NCT01185522|3099259|Superiority or Other||Odds Ratio (OR)|1.16||||0.004|2-Sided|95.0|1.05|1.28|||Univariate logistic regression model|||Predictive factor: C-Reactive Protein|
1684897|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|1.63||||0.036|2-Sided|95.0|1.03|2.58|||Multivariate logistic regression model|||Comparison between time since initial diagnosis: >= 10 years and < 10 years|
1684898|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|0.93||||0.858|2-Sided|95.0|0.57|1.52|||Univariate logistic regression model|||Comparison between HADS score: Depression (No Case) and HADS score: Depression (Certain case)|
1684899|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|1.09||||0.858|2-Sided|95.0|0.65|1.81|||Univariate logistic regression model|||Comparison between HADS score: Depression (No Case) and HADS score: Depression (Doubtful case)|
1684900|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|0.78||||0.399|2-Sided|95.0|0.48|1.26|||Univariate logistic regression model|||Comparison between HADS score: Anxiety (No case) and HADS score: Anxiety (Certain case)|
1684901|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|1.08||||0.399|2-Sided|95.0|0.6|1.93|||Univariate logistic regression model|||Comparison between HADS score: Anxiety (No case) and HADS score: Anxiety (Doubtful case)|
1684902|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|2.28|||<|0.001|2-Sided|95.0|1.5|3.47|||Univariate logistic regression model|||Comparison between SF36 vitality score: > 33 and <= 33|
1684903|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|2.08|||<|0.001|2-Sided|95.0|1.38|3.14|||Univariate logistic regression model|||Comparison between VAS patient: global assessment score: <= 67 and > 67|
1684904|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|1.66|||<|0.261|2-Sided|95.0|0.95|2.89|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: <= 30 and > 77|
1684905|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|1.17|||<|0.261|2-Sided|95.0|0.67|2.05|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: <= 30 and 59 - 77|
1684906|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|1.54|||<|0.261|2-Sided|95.0|0.86|2.75|||Univariate logistic regression model|||Comparison between VAS patient (quality of sleep) score: <=30 score and 30 - 59 score|
1684907|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|2.04|||<|0.001|2-Sided|95.0|1.35|3.08|||Univariate logistic regression model|||Comparison between VAS patient: pain <= 66 and > 66|
1684908|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|2.19|||<|0.001|2-Sided|95.0|1.45|3.31|||Univariate logistic regression model|||Comparison between VAS patient: fatigue <= 66 and > 66|
1684909|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|1.34|||<|0.153|2-Sided|95.0|0.9|2.0|||Univariate logistic regression model|||Comparison between HAQ score: <= 1.5 and > 1.5|
1684910|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|1.14|||<|0.511|2-Sided|95.0|0.77|1.71|||Univariate logistic regression model|||Comparison between dose of corticosteroids: <= 5 mg and > 5 mg|
1684912|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|1.39|||<|0.119|2-Sided|95.0|0.92|2.1|||Univariate logistic regression model|||Comparison between ESR: <= 28 mm/h and > 28 mm/h|
1684913|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|1.74|||<|0.01|2-Sided|95.0|1.14|2.65|||Univariate logistic regression model|||Comparison between DAS-28 score: <= 5.1 and DAS-28 >5.1|
1684914|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|1.47|||<|0.144|2-Sided|95.0|0.88|2.46|||Univariate logistic regression model|||Comparison between participants without erosive rheumatoid arthritis (RA) and participants with erosive RA|
1684915|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|1.49|||<|0.05|2-Sided|95.0|1.0|2.23|||Univariate logistic regression model|||Comparison between time since initial diagnosis: >= 10 years and < 10 years|
1684916|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|0.82|||<|0.331|2-Sided|95.0|0.55|1.22|||Univariate logistic regression model|||Comparison between Age: <= 55 years and > 55 years|
1684917|NCT01185522|3099260|Superiority or Other||Odds Ratio (OR)|0.74|||<|0.235|2-Sided|95.0|0.45|1.22|||Univariate logistic regression model|||Comparison between genders: women and men.|
1684918|NCT01185353|3099275|Superiority or Other|||||||0.097||||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684919|NCT01185353|3099275|Superiority or Other|||||||0.018||||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684920|NCT01185353|3099275|Superiority or Other|||||||0.164||||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684921|NCT01185353|3099275|Superiority or Other|||||||0.203||||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684922|NCT01185353|3099276|Superiority or Other|||||||0.001||||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684923|NCT01185353|3099276|Superiority or Other||||||<|0.001||||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684924|NCT01185353|3099276|Superiority or Other||||||<|0.135||||||A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684925|NCT01185353|3099276|Superiority or Other||||||<|0.005|||||||ANCOVA|A priori p-value significance threshold: 2-sided ≤0.10.|||
1684926|NCT01185353|3099277|Superiority or Other|||||||0.266||||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684927|NCT01185353|3099277|Superiority or Other|||||||0.14||||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684928|NCT01185353|3099277|Superiority or Other|||||||0.578||||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684929|NCT01185353|3099277|Superiority or Other|||||||0.449||||||P-value is for MCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684930|NCT01185353|3099277|Superiority or Other|||||||0.012||||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684931|NCT01185353|3099277|Superiority or Other||||||<|0.001||||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684932|NCT01185353|3099277|Superiority or Other||||||<|0.194||||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684933|NCT01185353|3099277|Superiority or Other||||||<|0.021||||||P-value is for PCS. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684934|NCT01185353|3099278|Superiority or Other||||||<|0.001||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684935|NCT01185353|3099278|Superiority or Other||||||<|0.001||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684936|NCT01185353|3099278|Superiority or Other||||||<|0.073||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684937|NCT01185353|3099278|Superiority or Other||||||<|0.015||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684938|NCT01185353|3099280|Superiority or Other|||||||0.001||||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact||||
1684939|NCT01185353|3099280|Superiority or Other||||||<|0.001||||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact||||
1684940|NCT01185353|3099280|Superiority or Other||||||<|0.019||||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact||||
1684941|NCT01185353|3099280|Superiority or Other||||||<|0.033||||||P-value is for Remission - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact||||
1684942|NCT01185353|3099280|Superiority or Other||||||<|0.007||||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact||||
1684943|NCT01185353|3099280|Superiority or Other||||||<|0.001||||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact||||
1684944|NCT01185353|3099280|Superiority or Other||||||<|0.371||||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact||||
1684945|NCT01185353|3099280|Superiority or Other||||||<|0.409||||||P-value is for Low Disease Activity - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|Fisher Exact||||
1684946|NCT01185353|3099282|Superiority or Other||||||<|0.001||||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel||||
1684947|NCT01185353|3099282|Superiority or Other||||||<|0.001||||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel||||
1684948|NCT01185353|3099282|Superiority or Other||||||<|0.012||||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel||||
1684949|NCT01185353|3099282|Superiority or Other||||||<|0.12||||||P-value is for comparison of the superiority of the LY3009104 dose level vs. placebo for the ordinal levels of response - Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Cochran-Mantel-Haenszel||||
1684950|NCT01185353|3099284|Superiority or Other||||||<|0.001||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1685666|NCT01174446|3100760|Superiority or Other|||||||0.5792|||||||Paired t-test||||
1684953|NCT01185353|3099284|Superiority or Other||||||<|0.024||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684954|NCT01185353|3099286|Superiority or Other||||||<|0.001||||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684955|NCT01185353|3099286|Superiority or Other||||||<|0.001||||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684956|NCT01185353|3099286|Superiority or Other||||||<|0.082||||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684957|NCT01185353|3099286|Superiority or Other||||||<|0.001||||||P-value is for Patient's Assessment of Pain - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684958|NCT01185353|3099286|Superiority or Other||||||<|0.001||||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684959|NCT01185353|3099286|Superiority or Other||||||<|0.001||||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684960|NCT01185353|3099286|Superiority or Other||||||<|0.072||||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684961|NCT01185353|3099286|Superiority or Other||||||<|0.001||||||P-value is for Patient's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684962|NCT01185353|3099286|Superiority or Other||||||<|0.001||||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684963|NCT01185353|3099286|Superiority or Other||||||<|0.001||||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684964|NCT01185353|3099286|Superiority or Other||||||<|0.092||||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684965|NCT01185353|3099286|Superiority or Other||||||<|0.217||||||P-value is for Physician's Assessment of DA - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684966|NCT01185353|3099288|Superiority or Other|||||||0.029||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684967|NCT01185353|3099288|Superiority or Other|||||||0.008||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684968|NCT01185353|3099288|Superiority or Other|||||||0.458||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684969|NCT01185353|3099288|Superiority or Other|||||||0.039||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684970|NCT01185353|3099290|Superiority or Other|||||||0.368||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684971|NCT01185353|3099290|Superiority or Other|||||||0.008||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684972|NCT01185353|3099290|Superiority or Other|||||||0.108||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684973|NCT01185353|3099290|Superiority or Other|||||||0.016||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684974|NCT01185353|3099292|Superiority or Other|||||||0.001||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684975|NCT01185353|3099292|Superiority or Other||||||<|0.001||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684976|NCT01185353|3099292|Superiority or Other||||||<|0.167||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684977|NCT01185353|3099292|Superiority or Other||||||<|0.003||||||P-value is for Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684978|NCT01185353|3099294|Superiority or Other|||||||0.002||||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684979|NCT01185353|3099294|Superiority or Other||||||<|0.001||||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684980|NCT01185353|3099294|Superiority or Other||||||<|0.201||||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684981|NCT01185353|3099294|Superiority or Other||||||<|0.116||||||P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684982|NCT01185353|3099294|Superiority or Other||||||<|0.001||||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684983|NCT01185353|3099294|Superiority or Other||||||<|0.001||||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684984|NCT01185353|3099294|Superiority or Other||||||<|0.064||||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684985|NCT01185353|3099294|Superiority or Other||||||<|0.48||||||P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.|ANCOVA||||
1684986|NCT01185353|3099298|Superiority or Other||||||<|0.001||||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact||||
1684987|NCT01185353|3099298|Superiority or Other||||||<|0.001||||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact||||
1684988|NCT01185353|3099298|Superiority or Other||||||<|0.109||||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact||||
1684989|NCT01185353|3099298|Superiority or Other||||||<|0.017||||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact||||
1684990|NCT01185353|3099300|Superiority or Other||||||<|0.001||||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact||||
1684991|NCT01185353|3099300|Superiority or Other||||||<|0.001||||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact||||
1684992|NCT01185353|3099300|Superiority or Other||||||<|0.162||||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact||||
1685667|NCT01174446|3100761|Superiority or Other|||||||0.3864|||||||Paired t-test||||
1684993|NCT01185353|3099300|Superiority or Other||||||<|0.003||||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact||||
1684994|NCT01185353|3099302|Superiority or Other||||||<|0.001||||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact||||
1684995|NCT01185353|3099302|Superiority or Other||||||<|0.001||||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact||||
1684996|NCT01185353|3099302|Superiority or Other||||||<|0.088||||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact||||
1684997|NCT01185353|3099302|Superiority or Other||||||<|0.045||||||P-value is for Week 12. A priori p-value significance threshold: 1-sided ≤0.10.|Fisher Exact||||
1684998|NCT01185353|3099304|Superiority or Other||||||<|0.001||||||A priori p-value significance threshold: 1-sided ≤0.10|Regression, Logistic||||
1684999|NCT01185340|3099323|Superiority or Other|||||||0.751|||||||Mixed Models Analysis||||
1685000|NCT01185249|3099344|Superiority or Other|||||||0.01|||||||t-test, 1 sided||||
1685001|NCT01185249|3099344|Non-Inferiority or Equivalence|Null hypothesis-no difference in morning and evening weights on three consecutive days.|Mean Difference (Final Values)|0.62|Standard Deviation|3.09|<|0.001|2-Sided|95.0|-0.51306|1.73806|||t-test, 1 sided|||Analysis of within subjects design morning and evening weights. Null hypothesis is that there is no difference between morning and evening weights.|
1685002|NCT01184989|3099363|Non-Inferiority or Equivalence|Bioavailability analysis|Ratio|92.37|Standard Deviation|23.5||||90.0|90.079|94.719|||||The Dispersion Value is actually the intraindividual gCV.|Estimated central measurements are compared to HPLC-MS/MS measurements. The comparison was done for the 468 quantifiable measurements.|
1685003|NCT01184989|3099364|Non-Inferiority or Equivalence|Bioavailability analysis|Ratio|102.16|Standard Deviation|22.8||||90.0|97.64|106.893|||||Dispersion value is actually the intraindividual gCV.|Estimated local measurements are compared to HPLC-MS/MS measurements. The comparison was done for the 136 quantifiable measurements.|
1685004|NCT01184859|3099391|Superiority or Other||Mean Difference (Net)|-0.888||||0.001|2-Sided|95.0|-1.426|-0.351||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.|||
1685005|NCT01184859|3099391|Superiority or Other||Mean Difference (Net)|-0.854|||<|0.001|2-Sided|95.0|-1.317|-0.391||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.|||
1685006|NCT01184859|3099391|Superiority or Other||Mean Difference (Net)|-0.547|||<|0.015|2-Sided|95.0|-0.985|-0.108||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.|||
1685007|NCT01184859|3099391|Superiority or Other||Mean Difference (Net)|-0.272|||<|0.194|2-Sided|95.0|-0.685|-0.141||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|ANCOVA|Gender is a factor, and duration of action and baseline number of nocturnal voids are covariates.|||
1685008|NCT01184859|3099392|Superiority or Other||||||<|0.001||||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided||||
1685009|NCT01184859|3099392|Superiority or Other||||||<|0.001||||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided||||
1685010|NCT01184859|3099392|Superiority or Other||||||<|0.01||||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided||||
1685011|NCT01184859|3099392|Superiority or Other||||||<|0.211||||||The p-value was not adjusted for multiplicity, because this study was not a confirmatory trial. A priori threshold for statistical significance is 0.05.|t-test, 2 sided||||
1685012|NCT01184755|3099407|Superiority or Other||Mean Difference (Final Values)|-0.391195|Standard Error of the Mean|0.140034||0.006|2-Sided|95.0|-0.667312|-0.115079|||mixed effects regression analysis|||This is the analysis of change in diastolic BP from Ambulatory BP monitoring.|
1685013|NCT01184755|3099407|Superiority or Other||Mean Difference (Final Values)|-0.561256|Standard Error of the Mean|0.216403||0.01|2-Sided|95.0|-0.987999|-0.134513||This is an intention-to-treat analysis|Mixed effects regression analysis|||This is the change in Systolic BP at 8 weeks|
1685014|NCT01184508|3099409|Superiority or Other|||||||0.607||||||The p-value is for the percentage of participants using breakthrough medication at Month 3.|Fisher Exact||||
1685015|NCT01184508|3099411|Superiority or Other||Least squares (LS) mean difference|-0.25||||0.688|2-Sided|90.0|-1.3|0.8||The p-value is for the change from baseline to Week 12 in MIBS-4 overall weighted score.|ANCOVA|Fixed effects: pooled investigator, treatment group, and baseline.|||
1685016|NCT01184508|3099412|Superiority or Other||LS mean difference|1.89||||0.72|2-Sided|90.0|-6.81|10.58||The p-value is for the change from baseline to Week 12 in MSQ emotional function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group*visit, baseline and baseline*visit.|||
1685017|NCT01184508|3099412|Superiority or Other||LS mean difference|-2.17||||0.591|2-Sided|90.0|-8.85|4.5||The p-value is for the change from baseline to Week 12 in MSQ preventive function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group*visit, baseline and baseline*visit.|||
1685018|NCT01184508|3099412|Superiority or Other||Least squares (LS) mean difference|-0.27||||0.963|2-Sided|90.0|-9.76|9.23||The p-value is for the change from baseline to Week 12 in MSQ restrictive function score.|ANCOVA|Fixed effects: investigator (pooled site), treatment group, visit, treatment group*visit, baseline and baseline*visit.|||
1685019|NCT01184508|3099415|Superiority or Other||Least squares (LS) mean difference|-1.57||||0.174|2-Sided|90.0|-3.48|0.34||The p-value is for the mean change from baseline to Month 3 in the number of migraine days.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group*month, baseline, baseline*month; Random effect: pts; Repeated effect: month.|||
1685020|NCT01184508|3099416|Superiority or Other||LS mean difference|-2.7||||0.606|2-Sided|90.0|-11.51|6.1||The p-value is for the change from baseline to Month 3 in average duration of nausea.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, tx group, month, tx group*month, baseline, baseline*month; Random effect: pts; Repeated effect: month.|||
1685021|NCT01184508|3099416|Superiority or Other||LS mean difference|7.3||||0.276|2-Sided|90.0|-3.91|18.52||The p-value is for the change from baseline to Month 3 in average duration of phonophobia.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, tx group, month, tx group*month, baseline, baseline*month; Random effect: pts; Repeated effect: month.|||
1685022|NCT01184508|3099416|Superiority or Other||Least squares (LS) mean difference|1.75||||0.77|2-Sided|90.0|-8.27|11.76||The p-value is for the change from baseline to Month 3 in average duration of photophobia.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group*month, baseline, baseline*month; Random effect: pts; Repeated effect: month.|||
1685023|NCT01184508|3099418|Superiority or Other||Least squares (LS) mean difference (Net)|-1.03||||0.085|2-Sided|90.0|-2.02|-0.05||The comparison between LY2300559 and placebo for the LS mean change from baseline to Month 3 in the number of migraine attacks was conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed-effects model repeated-measures|Fixed effects: pooled investigator, treatment (tx) group, month, tx group*month, baseline, baseline*month; Random effect: pts; Repeated effect: month.|||
1685024|NCT01184417|3099422|Superiority or Other||Mean Difference (Final Values)|6.0|||||2-Sided|95.0|-11.0|23.0|||||||
1685025|NCT01184417|3099424|Superiority or Other||Mean Difference (Final Values)|42.0|||||2-Sided|95.0|-4.0|82.0|||||||
1685026|NCT01184417|3099425|Superiority or Other||Mean Difference (Final Values)|23.0|||||2-Sided|95.0|4.0|49.0|||||||
1685027|NCT01184417|3099426|Superiority or Other||Mean Difference (Final Values)|17.0|||||2-Sided|95.0|4.0|32.0|||||||
1685028|NCT01184079|3099438|Superiority or Other|||||||0.26|||||||Chi-squared|||null hypothsesis: no difference in proportion of side effects reported between groups|
1685029|NCT01184079|3099440|Non-Inferiority or Equivalence|"Sample size: (1 + 1/u)(Zα + Zβ)2 σ2 /[log (RGMT) −δ0] u= ratio of the size of the Standard schedule to Alternate schedule groups (u =1, for equal size groups); one-sided alpha (0.025)/4 for multiplicity of serotypes. Average log-transformed and geometric mean titers (GMTs) with a two-sided 95% confidence interval of the ratio of the GMTs were used.~Non-inferiority is determined if upper bound GMT ratio of standard group to alternate group < 1.5."|largest upper bound GMT ratio|0.82|||||||||||||Non-inferiority is determined if upper bound GMT ratio of standard 6 month group to alternate 12 month group < 1.5.|The primary endpoint would demonstrate noninferiority if the upper bound of the 95% two-sided confidence interval (CI) of the ratio of GMT for Standard schedule group divided by that of Alternate schedule group is <1.5.|
1685030|NCT01183858|3099456|Superiority or Other||Hazard Ratio (HR)|1.06||||0.625|2-Sided|95.0|0.84|1.33|||Log Rank||||
1685031|NCT01183858|3099462|Superiority or Other||Hazard Ratio (HR)|1.05||||0.671|2-Sided|95.0|0.83|1.33||Unstratified analysis.|Log Rank||||
1685032|NCT01183780|3099467|Superiority or Other (legacy)|||||||0.6336|||||||Cochran-Mantel-Haenszel||||
1685033|NCT01183780|3099468|Superiority or Other (legacy)||Hazard Ratio (HR)|0.793||||0.0005|2-Sided|95.0|0.697|0.903|||Log Rank|Analysis was performed on stratified data.|Analysis was performed on stratified data.||
1685034|NCT01183780|3099469|Superiority or Other (legacy)||Hazard Ratio (HR)|0.844||||0.0219|2-Sided|95.0|0.73|0.976|||Log Rank|The analysis was performed on stratified data.|The estimation was performed on stratified data.||
1685035|NCT01183689|3099473|Superiority||Odds Ratio (OR)|2.35||||0.004|2-Sided|95.0|1.4|3.94||2 degree of freedom likelihood ratio statistic to compare differences among the 3 arms|Regression, Logistic|No adjustments|The 95% confidence interval for the odds ratio comparing groups 1 and 3 excludes 0.|Logistic regression analysis was used to compare the rates of daily self-weighing at 2 years among the 3 groups.|
1685036|NCT01183689|3099473|Superiority|Chi-squared test to compare the percentage of participants reporting self-weighing more than once per week among the 3 arms.|Odds Ratio (OR)|1.77||||0.004|2-Sided|95.0|1.04|3.02||This is based on a 2 degree of freedom likelihood ratio test to compare differences among the 3 arms.|Regression, Logistic||The 95% confidence interval for the odds ratio comparing the rates of self-weighing at year 2 between groups 1 and 2 excludes 0.|Logistic regression to compare differences among the 3 groups|
1685037|NCT01183689|3099474|Superiority||Mean Difference (Net)|-2.42||||0.001|2-Sided|95.0|-3.69|-1.14||The p-value is from a 2 degree of freedom F-test for differences among the 3 arms|ANOVA||The 95% confidence interval for differences between groups 1 and 3 does not include 0.|Mean change in waist girth from baseline to year 2|
1685038|NCT01183689|3099474|Superiority||Mean Difference (Net)|-1.27||||0.001|2-Sided|95.0|-2.55|0.02||2 degree of freedom F-test from analysis of variance to compare changes in waist circumference from baseline among the three arms|ANOVA|No adjustment to degrees of freedom|Difference between groups 1 and 2: 95% confidence interval includes 0|2 degree of freedom F-test from ANOVA to compare differences among 3 arms|
1685039|NCT01183689|3099475|Superiority||Mean Difference (Net)|-50.0||||0.58|2-Sided|95.0|-162.0|61.0||This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups|ANOVA|||Analysis of variance was used to assess mean differences in 2 year changes in kilocalories intake among the 3 groups.|
1685040|NCT01183689|3099475|Superiority||Mean Difference (Net)|-52.0||||0.58|2-Sided|95.0|-164.0|60.0||2 degree of freedom F-test to compare 3 arms with respect to 2-year changes in kilocalories|ANOVA|||2 degree of freedom F-test to compare mean differences among 3 arms in changes in kilocalories from baseline to year 2|
1685041|NCT01183689|3099476|Superiority||Mean Difference (Net)|-0.3||||0.02|2-Sided|95.0|-0.52|-0.08||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.|
1685042|NCT01183689|3099476|Superiority||Mean Difference (Net)|-0.12||||0.02|2-Sided|95.0|-0.34|0.1||2 degree of freedom F-test from analysis of variance, with no adjustment for multiple outcomes|ANOVA|||2 degree of freedom F-test to compare mean 2 year differences among 3 arms|
1685284|NCT01179672|3099963|Superiority or Other||Mean Difference (Final Values)|-1.26||||0.02|2-Sided|95.0|-2.33|-0.2|||Mixed Models Analysis||||
1685661|NCT01174563|3100736|Superiority||Hazard Ratio (HR)|0.58||||0.005|2-Sided|95.0|0.41|0.83|||Log Rank||||
1685043|NCT01183689|3099477|Superiority||Mean Difference (Net)|-0.05||||0.2|2-Sided|95.0|-1.45|1.35||This p-value is from an analysis of variance comparing all 3 groups.|ANOVA||The 95% confidence interval for differences between groups 1 and 3 includes 0.|Analysis of variance was used to compare differences among the 3 groups.|
1685044|NCT01183689|3099477|Superiority||Mean Difference (Net)|1.08||||0.2|2-Sided|95.0|-0.84|3.0||This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess mean differences among the 3 arms.|ANOVA||The 95% confidence interval for differences between groups 1 and 2 includes 0.|Mean differences from baseline to year 2 among the 3 arms were assessed using analysis of variance.|
1685045|NCT01183689|3099478|Superiority||Mean Difference (Net)|-1.21||||0.03|2-Sided|95.0|-2.11|-0.3||This p-value is from a 2 degree of freedom F-test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences from baseline to 2 years among the 3 groups.|
1685046|NCT01183689|3099478|Superiority||Mean Difference (Net)|-0.46||||0.03|2-Sided|95.0|-1.37|0.45||This p-value is from a 2 degree of freedom F-test from an analysis of variance to assess differences among the 3 arms.|ANOVA|||Mean changes between baseline and year 2 were compared among the 3 arms using analysis of variance.|
1685047|NCT01183689|3099479|Superiority||Mean Difference (Net)|-1.66||||0.05|2-Sided|95.0|-3.0|-0.32||This p-value is from an F-test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in changes from baseline to 2 years among the 3 groups.|
1685048|NCT01183689|3099479|Superiority||Mean Difference (Net)|-1.08||||0.05|2-Sided|95.0|-2.44|0.28||This p-value is from a 2 degree of freedom F-test to compare the 3 arms within an analysis of variance.|ANOVA||No significant difference between groups 1 and 2.|Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.|
1685049|NCT01183689|3099480|Superiority||Mean Difference (Net)|1.44||||0.75|2-Sided|95.0|-2.61|5.49||This p-value is from a 2 degree of freedom test.|ANOVA||No significant differences between groups 1 and 3.|Analysis of variance was used to compare mean changes among the 3 groups.|
1685050|NCT01183689|3099480|Superiority||Mean Difference (Net)|0.17||||0.75|2-Sided|95.0|-3.89|4.23||This p-value is from a 2 degree of freedom F-test from analysis of variance.|ANOVA|||Mean changes from baseline to year 2 among the 3 arms were compared using analysis of variance.|
1685051|NCT01183689|3099481|Superiority||Mean Difference (Net)|2.21||||0.16|2-Sided|95.0|-0.09|4.51||This p-value is from a 2 degree of freedom F test.|ANOVA|||Analysis of variance was used to compared mean differences among the 3 groups.|
1685052|NCT01183689|3099481|Superiority||Mean Difference (Net)|1.52||||0.16|2-Sided|95.0|-0.77|3.81||This p-value is from a 2 degree of freedom F-test to compare the 3 arms using analysis of variance.|ANOVA|||Mean differences between baseline and year 2 were compared among the 3 arms using analysis of variance.|
1685053|NCT01183689|3099482|Superiority||Mean Difference (Net)|-0.15||||0.24|2-Sided|95.0|-0.32|0.02||This p-value is from the 2 degree of freedom test of differences among the 3 arms.|ANOVA|||Analysis of variance was used to compare differences in changes from baseline to 2 years among the three arms.|
1685054|NCT01183689|3099482|Superiority||Mean Difference (Net)|-0.08||||0.24|2-Sided|95.0|-0.24|0.09||This p-value is from a 2 degree of freedom test for differences among the 3 arms.|ANOVA|2 degree of freedom test from analysis of variance to assess mean differences among the 3 arms||2 degree of freedom F-test from analysis of variance to compare 2 year differences in general health index values among the 3 arms|
1685055|NCT01183689|3099483|Superiority||Median Difference (Net)|1.4|||<|0.001|2-Sided|95.0|0.82|1.98||This p-value is from the omnibus 2 degree of freedom test for mean differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.|
1685056|NCT01183689|3099483|Superiority||Mean Difference (Net)|-0.13|||<|0.001|2-Sided|95.0|-0.71|0.45||2 degree of freedom F-test from analysis of variance|ANOVA|2 degree of freedom F-test from analysis of variance to compare mean differences among arms||2 degree F-test from analysis of variance applied to 2 year changes in scores from baseline|
1685057|NCT01183689|3099484|Superiority||Mean Difference (Net)|0.88||||0.002|2-Sided|95.0|0.37|1.39||This p-value is from a 2 degree freedom test of differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to year 2 among the 3 groups.|
1685058|NCT01183689|3099484|Superiority|2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study|Mean Difference (Net)|0.2|||<|0.001|2-Sided|95.0|-0.31|0.71||2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study, not adjusted for multiple comparisons among endpoints|ANOVA|2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study||2 degree of freedom F-test from analysis of variance to compare 2 year differences from baseline among the 3 arms of the study|
1685059|NCT01183689|3099485|Superiority||Mean Difference (Net)|-0.1|||<|0.001|2-Sided|95.0|-0.57|0.37||This p-value is from a 2 degree of freedom test to compare differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years among the 3 groups.|
1685060|NCT01183689|3099485|Superiority|A 2 degree of freedom F-test from ANOVA was used to compare mean differences in changes among the 3 arms of the study.|Mean Difference (Net)|-0.85|||<|0.001|2-Sided|95.0|-1.32|-0.38||The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.|ANOVA|The p-value is from a 2 degree of freedom F test to assess differences among the 3 arms of the study.||Changes in units of the scale from baseline to 2 years|
1685061|NCT01183689|3099486|Superiority||Mean Difference (Net)|0.55||||0.002|2-Sided|95.0|0.02|1.08||This p-value is from a 2 degree of freedom test for differences among all 3 groups|ANOVA|||Differences among the 3 groups were based on analyses of variance.|
1685062|NCT01183689|3099486|Superiority||Mean Difference (Net)|-0.08||||0.002|2-Sided|95.0|-0.61|0.45||the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups|ANOVA|the p-value results from a 2 degree of freedom F-test to assess pairwise differences among the 3 groups||Mean changes from baseline to 2 years among the 3 groups were assessed using a 2 degree of freedom F-test|
1685063|NCT01183689|3099487|Superiority||Odds Ratio (OR)|2.13||||0.008|2-Sided|95.0|1.12|4.1||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|generalized estimating equations|||Generalized estimating equations were used. Differences were summarized with odds ratios.|
1685064|NCT01183689|3099487|Superiority||Odds Ratio (OR)|2.36|||<|0.001|2-Sided|95.0|1.23|4.52||The p-value is a 2 degree of freedom test from the generalized estimating equations analysis applied to the longitudinal binary data among the 3 study arms.|generalized estimating equations|||The average percentage of participants who were obese across follow-up were compared among the 3 arms using a generalized estimating equations approach for repeated binary measures. Participants were assigned values of 0 or 1 depending on their obesity status at each exam. Differences were summarized with odds ratios.|
1685065|NCT01183689|3099488|Superiority||Mean Difference (Net)|-1.89||||0.73|2-Sided|95.0|-4.36|0.58||This p-value is from a 2 degree of freedom test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean differences in total cholesterol changes from baseline among groups.|
1685066|NCT01183689|3099488|Superiority||Mean Difference (Net)|-1.3||||0.73|2-Sided|95.0|-6.12|3.52||The p-value results from a 2 degree of freedom F-test.|ANOVA|||Mean changes from baseline to 2 years were compared between Groups 1 and 2.|
1685067|NCT01183689|3099489|Superiority||Mean Difference (Net)|0.92||||0.06|2-Sided|95.0|-0.49|2.33||This p-value is from a 2 degree of freedom omnibus test for differences among the 3 groups.|ANOVA|||Analysis of variance was used to compare mean changes from baseline to 2 years in diastolic blood pressure.|
1685068|NCT01183689|3099489|Superiority||Mean Difference (Net)|1.73||||0.06|2-Sided|95.0|0.32|3.14||The p-value is from a 2 degree of freedom F-test from an analysis of variance to compare mean differences among the 3 arms.|ANOVA|||Mean differences from baseline to 2 years were compared among the 3 arms using analysis of variance.|
1685069|NCT01183689|3099490|Superiority||Mean Difference (Net)|0.93||||0.13|2-Sided|95.0|-0.98|2.84|||ANOVA|||Mean differences in systolic blood pressure between groups 1 and 3 over time.|
1685070|NCT01183689|3099490|Superiority||Mean Difference (Net)|1.99||||0.13|2-Sided|95.0|0.06|3.92||The p-value is from a 2 degree of freedom test for pairwise difference among the 3 arms within an analysis of variance.|ANOVA|||Analysis of variance to assess mean differences in changes from baseline in systolic blood pressure. This analysis compares groups 1 and 2.|
1685071|NCT01183689|3099491|Superiority||Median Difference (Net)|2.04|||<|0.05|2-Sided|95.0|1.11|2.98|||Mixed Models Analysis|A linear contrast was used to compare groups 1 and 3 at 24 months.||A linear contrast from a mixed effects model was used to compare mean differences at 24 months between groups 1 and 3.|
1685072|NCT01183689|3099491|Superiority||Mean Difference (Net)|1.31|Standard Error of the Mean|0.47|<|0.05|2-Sided|95.0|0.39|2.24|||Mixed Models Analysis|The p-value is based on a 2 degree of freedom Wald test within the mixed effect model to test for pairwise differences among the 3 arms.|Listed above is the mean difference between arms 1 and 2|Mean differences at 2 years are calculated from a linear contrast within a mixed effects model. Note that this comparison is between Groups 1 and 2.|
1685073|NCT01183689|3099492|Superiority||Odds Ratio (OR)|2.28|||<|0.05|2-Sided|95.0|1.64|3.19|||generalized estimating equations|||This is a parallel analysis, comparing groups 1 and 3, using generalized estimating equations to summarize the odds ratio for weight gain in group 1 versus group 3,|
1685074|NCT01183689|3099492|Other|Generalized Estimating Equations|Odds Ratio (OR)|1.41|||<|0.05|2-Sided|95.0|1.02|1.9|||Generalized Estimating Equations|||Generalized estimating equations were used to compare the average percent of weight gainers over time among the three groups. The null hypothesis was that there was no difference in these average percentages. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status. The percentages were summarized with odds ratios for weight gain over time.|
1685075|NCT01183689|3099493|Superiority||Mean Difference (Net)|2.64|||<|0.05|2-Sided|95.0|2.05|3.22|||Mixed Models Analysis|This was fitted with Proc Mixed in SAS.|95% confidence interval excludes 0|Mean changes from a random effects model applied to repeated measures to compute the average differences between groups over time. This entry is for the comparison between groups 1 and 3.|
1685076|NCT01183689|3099493|Superiority||Mean Difference (Net)|0.82|Standard Error of the Mean|0.3|<|0.05|2-Sided|95.0|0.23|1.41||No interim analyses were conducted. Pairwise differences among the three arms were assessed with a 2 degree of freedom Wald Test.|Mixed Models Analysis||Above is provided the mean difference between Arms 1 and 2.|Mean changes from random effects model applied to repeated measures to compute the average differences among groups over time.|
1685077|NCT01183650|3099494|Superiority or Other||Mean Difference (Final Values)|16.02||||||95.0|||||||||
1685078|NCT01183650|3099494|Superiority or Other||Median Difference (Final Values)|19.83||||||95.0|||||||||
1685079|NCT01183650|3099494|Superiority or Other||Median Difference (Final Values)|0.0||||||95.0|||||||||
1685080|NCT01183650|3099494|Superiority or Other||Median Difference (Final Values)|0.0||||||95.0|||||||||
1685081|NCT01183650|3099495|Superiority or Other||Ratio of Geometric Least Squares Means|1.03|||||2-Sided|90.0|0.83|1.29|||||Day 10 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)||
1685082|NCT01183650|3099495|Superiority or Other||Ratio of Geometric Least Squares Mean|1.33|||||2-Sided|90.0|1.07|1.67|||||Day 1 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)||
1685083|NCT01183650|3099495|Superiority or Other||Ratio of Geometric Least Squares Means|0.81|||||2-Sided|90.0|0.67|0.97|||||Day 10 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)||
1685084|NCT01183650|3099495|Superiority or Other||Ratio of Geometric Least Squares Means|0.98|||||2-Sided|90.0|0.81|1.18|||||Day 1 Tadalafil Ratio of Geometric Least Squares Means(Japanese/Caucasian)||
1685085|NCT01183650|3099496|Superiority or Other||Ratio of Geometric Least Squares Means|0.99|||||2-Sided|90.0|0.79|1.24|||||Day 10 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)||
1685086|NCT01183650|3099496|Superiority or Other||Ratio of Geometric Least Squares Means|1.31|||||2-Sided|90.0|1.05|1.64|||||Day 1 Metabolite IC710 Ratio of Geometric Least Squares Means (Japanese/Caucasian)||
1685087|NCT01183650|3099496|Superiority or Other||Ratio of Geometric Least Squares Means|0.8|||||2-Sided|90.0|0.64|1.0|||||Day 10 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)||
1685088|NCT01183650|3099496|Superiority or Other||Ratio of Geometric Least Squares Means|1.05|||||2-Sided|90.0|0.84|1.32|||||Day 1 Tadalafil Ratio of Geometric Least Squares Means (Japanese/Caucasian)||
1685285|NCT01179672|3099964|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.001|2-Sided|95.0|-0.96|-0.24|||Mixed Models Analysis||||
1685089|NCT01183390|3099515|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.4|||||2-Sided|90.0|96.99|101.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685090|NCT01183390|3099516|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.6|||||2-Sided|90.0|95.1|102.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685091|NCT01183312|3099518|Superiority or Other|||||||0.13|||||||Wilcoxon Signed Rank (paired)||||
1685092|NCT01183312|3099519|Superiority or Other|||||||0.89|||||||Wilcoxon Signed Rank (paired)||||
1685093|NCT01183312|3099520|Superiority or Other|||||||0.14|||||||Wilcoxon Signed Rank (paired)||||
1685094|NCT01183312|3099521|Superiority or Other|||||||0.56|||||||Wilcoxon Signed Rank (paired)||||
1685095|NCT01183312|3099522|Superiority or Other|||||||0.32|||||||Wilcoxon Signed Rank (paired)||||
1685096|NCT01183312|3099523|Superiority or Other|||||||0.51|||||||Wilcoxon Signed Rank (paired)||||
1685097|NCT01183312|3099524|Superiority or Other|||||||0.77|||||||wilcoxon signed rank (paired)||||
1685098|NCT01183234|3099527|Superiority or Other||Median Difference (Final Values)|0.0|||||2-Sided|90.0|-0.15|0.492|||||||
1685099|NCT01183234|3099528|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals for the ratio of the treatment regimen means were provided by back-transformation on to the linear scale and were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of geometric LS means|0.988|||||2-Sided|90.0|0.931|1.05|||||||
1685100|NCT01183234|3099529|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals for the ratio of the treatment regimen means were provided by back-transformation on to the linear scale and were assessed against the currently accepted bioequivalence criteria for log-transformed data (0.80, 1.25).|Ratio of geometric LS means|0.953|||||2-Sided|90.0|0.915|0.993|||||||
1685101|NCT01183104|3099551|Superiority or Other|||||||0.043|||||||ANCOVA||||
1685102|NCT01183104|3099552|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1685103|NCT01183104|3099553|Superiority or Other|||||||0.03|||||||ANCOVA||||
1685104|NCT01183104|3099554|Superiority or Other|||||||1|||||||Fisher Exact||||
1685105|NCT01183104|3099555|Superiority or Other|||||||0.002|||||||Fisher Exact||||
1685106|NCT01183104|3099556|Non-Inferiority or Equivalence|The pre-defined non-inferiority margin was 0.3%.|LS mean difference|0.11||||0.087|2-Sided|95.0|-0.02|0.24|||ANCOVA||||
1685107|NCT01183013|3099558|Superiority or Other||Odds Ratio (OR)|0.141||||0.0002||95.0|0.05|0.397|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685108|NCT01183013|3099558|Superiority or Other||Odds Ratio (OR)|0.238||||0.0009||95.0|0.102|0.557|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685109|NCT01183013|3099558|Superiority or Other||Odds Ratio (OR)|0.368||||0.0146||95.0|0.165|0.821|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685110|NCT01183013|3099558|Superiority or Other||Odds Ratio (OR)|0.443||||0.1561|2-Sided|95.0|0.143|1.365|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685111|NCT01183013|3099558|Superiority or Other||Odds Ratio (OR)|0.456||||0.0844|2-Sided|95.0|0.187|1.112|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685112|NCT01183013|3099558|Superiority or Other||Odds Ratio (OR)|0.649||||0.3052||95.0|0.284|1.482|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685113|NCT01183013|3099560|Superiority or Other||Mean Difference (Final Values)|-33.16||||0.0167|2-Sided|95.0|-60.23|-6.08|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685114|NCT01183013|3099560|Superiority or Other||Mean Difference (Final Values)|-36.33||||0.0126|2-Sided|95.0|-64.78|-7.89|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685115|NCT01183013|3099560|Superiority or Other||Mean Difference (Final Values)|-15.65||||0.2706|2-Sided|95.0|-43.6|12.3|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685116|NCT01183013|3099560|Superiority or Other||Mean Difference (Final Values)|-1.78||||0.8932|2-Sided|95.0|-27.95|24.38|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685286|NCT01179672|3099965|Superiority or Other|||||||0.168||||||P-value is for ≥75% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran Mantel Haenszel test was stratified by pooled investigator.|||
1685117|NCT01183013|3099560|Superiority or Other||Mean Difference (Final Values)|-4.94||||0.7021||95.0|-30.39|20.51|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685118|NCT01183013|3099560|Superiority or Other||Mean Difference (Final Values)|-36.61||||0.0057|2-Sided|95.0|-62.42|-10.8|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c and 2-hour PPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685119|NCT01183013|3099562|Superiority or Other||Mean Difference (Final Values)|-33.73|||<|0.0001|2-Sided|95.0|-42.57|-24.89|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685120|NCT01183013|3099562|Superiority or Other||Mean Difference (Final Values)|-25.87|||<|0.0001|2-Sided|95.0|-34.77|-16.98|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685121|NCT01183013|3099562|Superiority or Other||Mean Difference (Final Values)|-17.38|||<|0.0002|2-Sided|95.0|-26.35|-8.41|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685122|NCT01183013|3099562|Superiority or Other||Mean Difference (Final Values)|-6.5|||<|0.1466|2-Sided|95.0|-15.29|2.28|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685123|NCT01183013|3099562|Superiority or Other||Mean Difference (Final Values)|-1.84|||<|0.6839|2-Sided|95.0|-10.69|7.02|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685124|NCT01183013|3099562|Superiority or Other||Mean Difference (Final Values)|-3.68|||<|0.4275|2-Sided|95.0|-12.77|5.42|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, continuous baseline FPG, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685125|NCT01183013|3099564|Superiority or Other||Odds Ratio (OR)|8.521|||<|0.0001||95.0|4.63|15.681|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685126|NCT01183013|3099564|Superiority or Other||Odds Ratio (OR)|4.017|||<|0.0001||95.0|2.348|6.873|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685127|NCT01183013|3099564|Superiority or Other||Odds Ratio (OR)|2.696|||<|0.0002||95.0|1.594|4.559|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685128|NCT01183013|3099564|Superiority or Other||Odds Ratio (OR)|2.966|||<|0.0005|2-Sided|95.0|1.604|5.485|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685129|NCT01183013|3099564|Superiority or Other||Odds Ratio (OR)|1.707|||<|0.0506||95.0|0.999|2.918|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685130|NCT01183013|3099564|Superiority or Other||Odds Ratio (OR)|1.09|||<|0.754||95.0|0.637|1.863|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685131|NCT01183013|3099565|Superiority or Other||Odds Ratio (OR)|5.066|||<|0.0001||95.0|2.53|10.145|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685132|NCT01183013|3099565|Superiority or Other||Odds Ratio (OR)|4.58|||<|0.0001||95.0|2.263|9.266|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685133|NCT01183013|3099565|Superiority or Other||Odds Ratio (OR)|2.22|||<|0.0345||95.0|1.06|4.649|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685134|NCT01183013|3099565|Superiority or Other||Odds Ratio (OR)|1.269|||<|0.4039||95.0|0.726|2.217|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685135|NCT01183013|3099565|Superiority or Other||Odds Ratio (OR)|1.905|||<|0.0363||95.0|1.042|3.484|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685136|NCT01183013|3099565|Superiority or Other||Odds Ratio (OR)|1.126|||<|0.7359||95.0|0.565|2.243|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685137|NCT01183013|3099566|Superiority or Other||Odds Ratio (OR)|9.614|||<|0.0001||95.0|5.187|17.821|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685287|NCT01179672|3099965|Superiority or Other|||||||0.001||||||P-value is for ≥50% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.|||
1685138|NCT01183013|3099566|Superiority or Other||Odds Ratio (OR)|5.429|||<|0.0001||95.0|2.947|10.001|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685139|NCT01183013|3099566|Superiority or Other||Odds Ratio (OR)|2.804|||<|0.0009||95.0|1.524|5.159|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685140|NCT01183013|3099566|Superiority or Other||Odds Ratio (OR)|1.903|||<|0.0254||95.0|1.083|3.345|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685141|NCT01183013|3099566|Superiority or Other||Odds Ratio (OR)|1.746|||<|0.0546||95.0|0.989|3.083|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685142|NCT01183013|3099566|Superiority or Other||Odds Ratio (OR)|1.246|||<|0.4639||95.0|0.692|2.242|||Regression, Logistic|A logistic regression model with terms for treatment, continuous HbA1c baseline, prior use of antidiabetic agents and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685143|NCT01183013|3099567|Superiority or Other||Mean Difference (Final Values)|-0.89|||<|0.0001|2-Sided|95.0|-1.12|-0.66|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685144|NCT01183013|3099567|Superiority or Other||Mean Difference (Final Values)|-0.68|||<|0.0001|2-Sided|95.0|-0.91|-0.44|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685145|NCT01183013|3099567|Superiority or Other||Mean Difference (Final Values)|-0.44|||<|0.0003|2-Sided|95.0|-0.67|-0.2|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685146|NCT01183013|3099567|Superiority or Other||Mean Difference (Final Values)|-0.41|||<|0.0006|2-Sided|95.0|-0.64|-0.18|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685147|NCT01183013|3099567|Superiority or Other||Mean Difference (Final Values)|-0.37|||<|0.0016|2-Sided|95.0|-0.6|-0.14|||ANCOVA|The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685148|NCT01183013|3099567|Superiority or Other||Mean Difference (Final Values)|-0.17|||<|0.1571||95.0|-0.41|0.07||The model includes fixed effects for treatment, continuous baseline HbA1c, prior anti-diabetic medication and country.|ANCOVA|||Treatment comparisons are for fixed dose combination versus monotherapy.|
1685149|NCT01182844|3099574|Other||||||<|0.05|||||||t-test, 2 sided|||For comparison of independent, parametric data student t-test and for non-parametric data Mann– Whitney-U-test were used.|
1685150|NCT01182441|3099600|Non-Inferiority|This endpoint is met if either the 95% Credible Interval for the risk ratio < 2.0 or the 95% Credible Interval for the risk difference is < 0.0275.|Risk Ratio (RR)|1.6|||||2-Sided|95.0|0.5|4.2||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately for the WATCHMAN and Warfarin groups. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.|
1685151|NCT01182441|3099600|Non-Inferiority|This endpoint is met if either the 95% Credible Interval for the risk ratio < 2.0 or the 95% Credible Interval for the risk difference is < 0.0275.|Risk Difference (RD)|0.0053|||||2-Sided|95.0|-0.019|0.0273||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately for the WATCHMAN and Warfarin groups. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.|
1685152|NCT01182441|3099601|Non-Inferiority|This endpoint is met if the 95% Credible Interval for the rate ratio of WATCHMAN versus Warfarin is entirely less than 1.75.|Risk Ratio (RR)|1.07|||||2-Sided|95.0|0.57|1.89||||||A Bayesian piecewise exponential model was used to model the 18-month event rates. Historical priors for each interval model were based on PROTECT AF. Hazards were modeled for 0-7 day, 7-60 day, 60-182 day, and 182+ day intervals. Event rates were estimated separately by treatment group and event type. The posterior distribution for the 18-month event rate ratio (WATCHMAN vs. Warfarin), and the corresponding equitailed 95% credible interval, were determined via Monte Carlo simulations.|
1685153|NCT01182441|3099602|Superiority|Success for this endpoint was achieved if the probability of experiencing an event was statistically less than the performance goal, defined as 2.67%, with an upper bound of the one-sided 95% credible interval less than the performance goal.|probability of experiencing an event|2.2|||||1-Sided|95.0||2.652||||||Bayesian calculations were used to incorporate the data from PROTECT AF CAP Registry through a conjugate beta-binomial model. A one-sided upper 95% credible interval for the event rate was calculated based off this posterior distribution.|
1685154|NCT01182207|3099658|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.2|||||2-Sided|90.0|95.36|101.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685288|NCT01179672|3099965|Superiority or Other|||||||0.003||||||P-value is for ≥30% reduction in 24-hour BPI-Severity average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.|||
1685155|NCT01182207|3099659|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.88|||||2-Sided|90.0|95.62|102.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685156|NCT01182207|3099660|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.6|||||2-Sided|90.0|89.45|106.5|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685157|NCT01182207|3099661|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.72|||||2-Sided|90.0|100.67|104.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685158|NCT01182207|3099662|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.16|||||2-Sided|90.0|101.1|105.27|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685159|NCT01182207|3099663|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.74|||||2-Sided|90.0|86.82|107.79|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685160|NCT01182194|3099664|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||2-Sided|90.0|96.07|103.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685161|NCT01182194|3099665|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.54|||||2-Sided|90.0|94.55|102.71|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685162|NCT01182194|3099666|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.45|||||2-Sided|90.0|94.36|109.08|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685163|NCT01182194|3099667|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.47|||||2-Sided|90.0|95.35|101.7|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685164|NCT01182194|3099668|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.76|||||2-Sided|90.0|95.66|101.96|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685187|NCT01181726|3099701|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.99|||||2-Sided|90.0|94.11|102.02|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685165|NCT01182194|3099669|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.5|||||2-Sided|90.0|85.53|100.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685166|NCT01182181|3099670|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.3|||||2-Sided|90.0|93.14|99.57|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685167|NCT01182181|3099671|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.6|||||2-Sided|90.0|92.34|98.95|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685168|NCT01182103|3099672|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1685169|NCT01182103|3099673|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1685170|NCT01182103|3099674|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1685171|NCT01181986|3099675|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1685172|NCT01181986|3099676|Superiority or Other||||||<|0.0001|||||||ANCOVA|Adjusted for treatment sequence and diabetes duration group.|||
1685173|NCT01181986|3099677|Superiority or Other|||||||0.003|||||||ANCOVA|Adjusted for treatment sequence.|||
1685174|NCT01181986|3099677|Superiority or Other|||||||0.006|||||||ANCOVA|Adjusted for treatment sequence.|||
1685175|NCT01181986|3099677|Superiority or Other||||||<|0.0001|||||||ANCOVA|Adjusted for treatment sequence, group (diabetes duration) and time.|||
1685176|NCT01181895|3099690|Superiority or Other||Mean Difference (Final Values)|-0.006||||0.926|2-Sided|95.0|-0.124|0.113||P-value for the adjusted treatment difference for Salmetarol 50 µg BID versus Placebo.|ANCOVA||The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Salmeterol 50 µg BID versus Placebo.||
1685177|NCT01181895|3099690|Superiority or Other||Mean Difference (Final Values)|0.07||||0.244|2-Sided|95.0|-0.048|0.188||P-value for the adjusted treatment difference for Vilanterol 25 µg OD versus Placebo.|ANCOVA||The estimated value represents the adjusted treatment difference in the weighted mean 0-24 hour FEV1 (Liters) at Week 12 for Vilanterol 25 µg OD versus Placebo.||
1685178|NCT01181804|3099695|Non-Inferiority or Equivalence|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.15|||||2-Sided|90.0|1.09|1.21|||||||
1685179|NCT01181804|3099696|Non-Inferiority or Equivalence|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.1|||||2-Sided|95.0|1.06|1.14|||||||
1685180|NCT01181804|3099697|Non-Inferiority or Equivalence|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric mean ratio|1.43|||||2-Sided|90.0|1.32|1.54|||||||
1685181|NCT01181804|3099698|Non-Inferiority or Equivalence|Comparison of boceprevir tablet versus capsule used a mixed-effects model with fixed effects for formulation, sequence, and period, and a random effect for participant within sequence. The geometric mean ratio (GMR) of boceprevir tablet to boceprevir capsule is presented with two-sided 90% CIs. Equivalence of formulations was signified by the GMR falling within prespecified bioequivalence bounds.|Least Squares Geometric Mean Ratio|1.11|||||2-Sided|90.0|1.07|1.15|||||||
1685182|NCT01181778|3099700|Superiority or Other||Difference in Percentage: Undecided|-15.8|||<|0.0001|2-Sided|95.0|-17.6|-14.1|||Chi-squared|||Analysis of the difference in the percentage of participants who chose Undecided before physician counseling and after physician counseling.|
1685183|NCT01181778|3099700|Superiority or Other||Difference in Percentage: Other Method|-3.6|||<|0.0001|2-Sided|95.0|-5.0|-2.2|||Chi-squared|||Analysis of the difference in the percentage of participants who chose Other Method before physician counseling and after physician counseling.|
1685184|NCT01181778|3099700|Superiority or Other||Difference in Percentage: Monthy Ring|16.0|||<|0.0001|2-Sided|95.0|14.3|17.8|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Monthly Ring before physician counseling and after physician counseling.|
1685185|NCT01181778|3099700|Superiority or Other||Difference in Percentage: Weekly Patch|3.8|||<|0.0001|2-Sided|95.0|2.6|5.0|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Weekly Patch before physician counseling and after physician counseling.|
1685186|NCT01181778|3099700|Superiority or Other||Difference in Percentage: Daily Pill|-0.4|||<|0.705|2-Sided|95.0|-2.6|1.8|||Chi-squared|||Analysis of the difference in the percentage of participants who chose the Daily Pill before physician counseling and after physician counseling.|
1685188|NCT01181726|3099702|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.72|||||2-Sided|90.0|94.03|101.56|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685189|NCT01181726|3099703|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.13|||||2-Sided|90.0|94.39|104.1|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685190|NCT01181726|3099704|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.01|||||2-Sided|90.0|94.17|104.11|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685191|NCT01181726|3099705|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.96|||||2-Sided|90.0|93.66|102.46|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685192|NCT01181726|3099706|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.87|||||2-Sided|90.0|93.22|102.74|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685193|NCT01181726|3099707|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.01|||||2-Sided|90.0|94.54|101.6|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685194|NCT01181726|3099708|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.83|||||2-Sided|90.0|94.55|101.21|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685195|NCT01181726|3099709|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.19|||||2-Sided|90.0|94.71|103.87|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685196|NCT01181726|3099710|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.71|||||2-Sided|90.0|94.42|105.3|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685197|NCT01181726|3099711|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.77|||||2-Sided|90.0|93.92|101.78|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685198|NCT01181726|3099712|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.92|||||2-Sided|90.0|93.44|102.61|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685199|NCT01181726|3099713|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.23|||||2-Sided|90.0|91.17|99.47|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685278|NCT01180049|3099949|Superiority or Other||Difference between arms|13.3|||||2-Sided|80.0|-0.4|26.7||||||Investigator’s assessment- Difference (%)TEMSR 175/75 mg – TEMSR 75 mg (80% CI)|
1685200|NCT01181726|3099714|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.19|||||2-Sided|90.0|91.18|99.38|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685201|NCT01181726|3099715|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.33|||||2-Sided|90.0|92.21|107.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1685202|NCT01181726|3099716|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.25|||||2-Sided|90.0|91.18|99.51|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685203|NCT01181726|3099717|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.21|||||2-Sided|90.0|91.21|99.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685204|NCT01181726|3099718|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.35|||||2-Sided|90.0|92.21|107.06|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685205|NCT01181726|3099719|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.6|||||2-Sided|90.0|94.05|101.3|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685206|NCT01181726|3099720|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.4|||||2-Sided|90.0|93.91|101.02|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685207|NCT01181726|3099721|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.66|||||2-Sided|90.0|94.22|116.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1685208|NCT01181531|3099740|Superiority or Other||Odds Ratio (OR)|1.33||||0.346|2-Sided|95.0|0.74|2.39||stratified by type of Vitamin D at site|Cochran-Mantel-Haenszel||OR is Cinacalcet: Vitamin D||
1685209|NCT01181531|3099741|Superiority or Other||Odds Ratio (OR)|1.45||||0.11|2-Sided|95.0|0.92|2.29||Stratified by type of Vitamin D at site|Cochran-Mantel-Haenszel||OR is Cinacalcet: Vitamin D||
1685210|NCT01181531|3099742|Superiority or Other||Mean Difference (Final Values)|-5.0|Standard Error of the Mean|5.3||0.346|2-Sided|95.0|-15.4|5.4||Unadjusted. Model contains baseline stratification factor for type of Vitamin D administered at the site|Mixed Models Analysis||Cinacalcet - Vitamin D|Null hypothesis: no difference in % change from baseline in PTH comparing the two treatment arms.|
1685211|NCT01181479|3099750|Equivalence|Comparison of AG200-15 and Lessina for cycles 1-6.||||||0.067|||||||Chi-squared||||
1685212|NCT01181349|3099753|Superiority or Other||||||=|0|||||||Chi-square test or Fisher's Exact Test|||Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher’s Exact Test. All tests were performed at a significance level of 0.05.|
1685213|NCT01181349|3099755|Superiority or Other||||||=|0|||||||Chi-square test or Fisher's Exact Test|||Cross tables were performed between TOF ratio and medications administered. Statistical significance was evaluated using Chi-square test or Fisher’s Exact Test. All tests were performed at a significance level of 0.05.|
1685279|NCT01180049|3099950|Superiority or Other||Difference in arms|6.7|||||2-Sided|80.0|-6.9|20.3||||||Independent assessment- Difference (%) TEMSR 175/75 mg – TEMSR 75 mg (80% CI)|
1685280|NCT01180049|3099951|Superiority or Other||Hazard Ratio (HR)|0.778|||||2-Sided|80.0|0.568|1.064|||||||
1685281|NCT01180049|3099952|Superiority or Other||Hazard Ratio (HR)|0.731|||||2-Sided|80.0|0.52|1.027|||||||
1685214|NCT01181167|3099796|Non-Inferiority or Equivalence|"Difference in incidence of thromboembolic events between DU-176b and enoxaparin groups and 95% confidence interval (CI) were calculated.~Incidence of thromboembolic events and 95% CI also calculated by treatment group.~Only when null hypothesis H01 was rejected, upper limit of 95% CI for difference between DU-176b and enoxaparin groups was confirmed. When upper limit of 95% CI was below 0%, DU-176b was considered to be superior to enoxaparin in terms of the prevention of VTE."|Cox Proportional Hazard|-4.5|||<|0.001|1-Sided|95.0||||Farrington Manning Method|ANCOVA|||Hypothesis testing of proportion of subjects who experienced at least one thromboembolic events, defined as primary endpoint, carried out using Farrington-Manning method. Null hypothesis H˅01: Incidence of thromboembolic events in DU-176b group (P˅DU) = Incidence of thromboembolic events in enoxaparin group (P˅E) + Δ (8%). Alternative hypothesis H˅11: P˅DU < P˅E + Δ (significance level: One-sided, 0.025)|
1685215|NCT01181141|3099798|Superiority or Other||Cox Proportional Hazard|-3.5|||||2-Sided|95.0|-18.8|6.0|||||||
1685216|NCT01181128|3099827|Superiority or Other||Bleeding Rate Ratio|0.24|||<|0.001|2-Sided|95.0|0.12|0.46|||negative binomial model||||
1685217|NCT01181128|3099833|Superiority or Other||Bleeding Rate Ratio|0.08|||<|0.001|2-Sided|95.0|0.05|0.13|||negative binomial model|||The null hypothesis for the primary endpoint is no difference between the individualized (tailored) prophylaxis regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations. However it was projected to have > 90% power at the 2-sided 0.05 level of significance to detect a 60% reduction in annualized bleeding episodes, based upon this hypothesis test.|
1685218|NCT01181102|3099839|Superiority or Other||χ2 test|2.5|||||2-Sided|95.0|-0.8|5.9|||||||
1685219|NCT01181102|3099840|Non-Inferiority or Equivalence|"(non-inferiority) When analyzed using the Z test at a one-sided 0.025 significance level, with the addition of a non-inferiority margin of 5% to the incidence in the enoxaparin group.~(superiority) The incidence of thromboembolic events for the FAS was compared using the χ2 test (two-sided significance level: 0.05)"|Cox Proportional Hazard|-6.5|||<|0.001|2-Sided|95.0|-11.5|-1.6||non-inferiority:P < 0.001 superiority:P = 0.010|non-inferiority:Z test. superiority:χ2 t|||The incidence proportion of thromboembolic events in the DU-176b group (P˅DU) = The incidence proportion of thromboembolic events in the enoxaparin group (P˅E) + Δ (5%). Alternative hypothesis H˅11: P˅DU < P˅E + Δ (level of significance, 0.025; one-sided). If the null hypothesis H˅01 was rejected, the following analysis had to be sequentially performed using the χ2 test statistic. Null hypothesis H˅02: P˅DU = P˅E Alternative hypothesis H˅12: P˅DU ≠ P˅E (level of significance, 0.05; two-sided).|
1685220|NCT01181050|3099849|Superiority or Other||Treatment difference|-0.04||||0.8867||95.0|-0.65|0.56|||Mixed effect model repeated measures||||
1685221|NCT01181050|3099850|Superiority or Other||Treatment difference|0.06||||0.8293||95.0|-0.46|0.58|||Mixed effect model repeated measures||||
1685222|NCT01181050|3099851|Superiority or Other||Treatment difference|-0.02||||0.9334||95.0|-0.54|0.5|||Mixed effect model repeated measures||||
1685223|NCT01181011|3099866|Non-Inferiority or Equivalence|Bioequivalence|gMean Ratio|106.7|Standard Error of the Mean|1.03||0|2-Sided|90.0|100.9|112.9||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA||||
1685224|NCT01181011|3099867|Non-Inferiority or Equivalence|Bioequivalence|gMean Ratio|108.8|Standard Error of the Mean|1.04||0.0006|2-Sided|95.0|102.1|116.0||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA||||
1685225|NCT01181011|3099868|Non-Inferiority or Equivalence|Bioequivalence|gMean Ratio|109.7|Standard Error of the Mean|1.04||0.0011|2-Sided|90.0|102.87|117.07||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA||||
1685226|NCT01181011|3099869|Non-Inferiority or Equivalence|Bioequivalence|gMean Ratio|97.57|Standard Error of the Mean|1.09||0.0126|2-Sided|90.0|84.643|112.472||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA||||
1685227|NCT01181011|3099870|Non-Inferiority or Equivalence|Bioequivalence|gMean Ratio|109.84|Standard Error of the Mean|1.06||0.0139|2-Sided|90.0|99.96|120.71||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA||||
1685228|NCT01181011|3099871|Non-Inferiority or Equivalence|Bioequivalence|gMean Ratio|109.22|Standard Error of the Mean|1.06||0.0107||90.0|99.45|119.95||The p-value is for the ratio being outside the interval 0.8 to 1.25.|ANCOVA||||
1685229|NCT01180790|3099893|Superiority or Other|||||||0.34||||||To control for multiplicity, proportion of subjects in each treatment group achieving cEVR are analyzed using a Cochran-Armitage test for trend among the ordered treatment groups: 200 mg ACH-1625, 400 mg ACH-1625, and 800 mg ACH-1625.|Exact Cochran–Armitage test|Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).||The null hypothesis is no difference between proportions of subjects in each treatment group achieving cEVR at Week 12 of the study, while the alternative hypothesis is that the proportion of subjects achieving cEVR at Week 12 increases with increasing doses of ACH-0141625.|
1685230|NCT01180790|3099895|Superiority or Other|||||||0.004|||||||Fisher Exact|||To control for multiplicity, proportion in each treatment group achieving RVR4 are analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-1625, 400 mg ACH-1625, and 800 mg ACH-1625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).|
1685231|NCT01180790|3099895|Superiority or Other|||||||0.004|||||||Fisher Exact|||To control for multiplicity, proportion in each treatment group achieving RVR4 are analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-1625, 400 mg ACH-1625, and 800 mg ACH-1625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).|
1685232|NCT01180790|3099895|Superiority or Other|||||||0.004|||||||Fisher Exact|||To control for multiplicity, proportion in each treatment group achieving RVR4 are analyzed using a Cochran-Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-1625, 400 mg ACH-1625, and 800 mg ACH-1625. Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo - active).|
1685282|NCT01180036|3099953|Non-Inferiority|With a non-inferiority margin of 15%. enrollment of 63 evaluable patients per study are is required to achieve 80% power to show that RTX is not inferior.||||||0.009|||||||Chi-squared||||
1685233|NCT01180790|3099895|Superiority or Other|||||||0.003||||||To control for multiplicity, proportion in each treatment group achieving RVR4 are analyzed using a Cochran–Armitage test for trend among the ordered groups: placebo (considered zero dose), 200 mg ACH-1625, 400 mg ACH-1625, and 800 mg ACH-1625.|Exact Cohcran-Armitage test|Only if overall test for trend is significant are pairwise comparisons evaluated using p-values for the difference in proportions (placebo – active).||The null hypothesis is no difference between proportions of subjects in each treatment group achieving RVR4 at Week 4 of the study, while the alternative hypothesis is that the proportion of subjects achieving RVR4 at Week 4 increases with increasing doses of ACH-0141625.|
1685234|NCT01180660|3099901|Superiority or Other||Median Difference (Net)|19.0||||0.01|2-Sided|95.0|3.0|27.0|||Regression, Linear|||A sample size of 22 subjects per group was estimated to achieve 90% power to detect a 16 point difference in the aggregated Qor-40 score for the two study groups to be compared assuming an overall standard deviation of 16 points similar to what was observed in a previous investigation.|
1685235|NCT01180478|3099908|Superiority or Other|||||||0.553|||||||Chi-squared||||
1685236|NCT01180478|3099909|Superiority or Other|||||||0.17|||||||Chi-squared|||Comparison in the number of 'Other perioperative complication' between NBI and WL|
1685237|NCT01180478|3099909|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison in the number of 'Acute Abdomen' between NBI and WL|
1685238|NCT01180478|3099909|Superiority or Other|||||||0.5|||||||Fisher Exact|||Comparison in the number of 'Sepsis' between NBI and WL|
1685239|NCT01180478|3099909|Superiority or Other|||||||||||||||||Comparison in the number of 'Lung embolism' between NBI and WL|Non of the participants/patients had a lung embolism. Therefore, no p-value was available
1685240|NCT01180478|3099909|Superiority or Other|||||||0.5|||||||Fisher Exact|||Comparison in the number of 'CVA/TIA' between NBI and WL|
1685241|NCT01180478|3099909|Superiority or Other|||||||||||||||||Comparison in the number of 'DVT' between NBI and WL|Non of the participants/patients had DVT. Therefore, the p-value is not available
1685242|NCT01180478|3099909|Superiority or Other|||||||0.111|||||||Chi-squared|||Comparison in the number of 'Bladder cramps' between NBI and WL|
1685243|NCT01180478|3099909|Superiority or Other|||||||0.569|||||||Chi-squared|||Comparison in the number of 'UTI' between NBI and WL|
1685244|NCT01180478|3099909|Superiority or Other|||||||0.666|||||||Chi-squared|||Comparison of the numbers in 'Fever' between NBI and WL|
1685245|NCT01180478|3099909|Superiority or Other|||||||0.311|||||||Chi-squared|||Comparison of the numbers in 'Bleeding' between NBI and WL|
1685246|NCT01180478|3099910|Superiority or Other|||||||0.17|||||||Fisher Exact|The analysis was performed by using the Fisher exact test, because the criteria for using the Chi square test were not met.||The statistical analyses refers to comparison of the different 8 categories (one variable) mentioned of the Clavien grading of perioperative complications between Narrow Band Imaging and White Light Trans Urethral Resection.|
1685247|NCT01180478|3099911|Superiority or Other|||||||0.742|||||||Chi-squared||||
1685248|NCT01180478|3099912|Superiority or Other|||||||0.585|||||||Log Rank|||The expected recurrence rate in the WL-assisted TURBT group was 35%.14 To detect a clinically relevant difference in recurrence detection rates ≥10% at a 5% significance level and a power of 80%, the required sample size per treatment was calculated to be 329 patients (658 patients in total).|
1685249|NCT01180400|3099913|Superiority or Other||LS mean|-0.4|Standard Error of the Mean|2.11||0.842|2-Sided|95.0|-4.58|3.73||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1685250|NCT01180400|3099913|Superiority or Other||LS mean|-0.011|Standard Error of the Mean|0.0198||0.576|2-Sided|95.0|-0.05|0.0279||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1685251|NCT01180400|3099914|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.1||0.942|2-Sided|95.0|-0.2|0.19|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.|
1685252|NCT01180400|3099915|Superiority or Other||LS mean|-0.1|Standard Error of the Mean|0.1||0.345|2-Sided|95.0|-0.3|0.1|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1685253|NCT01180400|3099916|Superiority or Other||LS mean|0.15|Standard Error of the Mean|1.592||0.924|2-Sided|95.0|-2.981|3.286|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1685254|NCT01180400|3099917|Superiority or Other||LS mean|0.1|Standard Error of the Mean|0.27||0.62|2-Sided|95.0|-0.4|0.68|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.|
1685255|NCT01180400|3099918|Superiority or Other||LS mean|-0.1|Standard Error of the Mean|0.27||0.756|2-Sided|95.0|-0.62|0.45|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1685256|NCT01180400|3099919|Superiority or Other||LS mean|-0.4|Standard Error of the Mean|0.3||0.201|2-Sided|95.0|-0.98|0.21||Analysis for change in SDS work/school domain score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1685283|NCT01180036|3099954|Superiority||Risk Difference (RD)|40.0||||0.001|2-Sided|95.0|24.6|55.4|||Chi-squared||||
1685662|NCT01174446|3100757|Superiority or Other|||||||0.9363|||||||Paired t-test||||
1685257|NCT01180400|3099920|Superiority or Other||LS mean|-0.04|Standard Error of the Mean|0.766||0.956|2-Sided|95.0|-1.549|1.466||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1685258|NCT01180400|3099921|Superiority or Other||LS mean|1.3|Standard Error of the Mean|0.86||0.145|2-Sided|95.0|-0.44|2.95|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.|
1685259|NCT01180400|3099922|Superiority or Other||LS mean|1.0|Standard Error of the Mean|0.77||0.187|2-Sided|95.0|-0.49|2.52|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1685260|NCT01180400|3099923|Superiority or Other||LS mean|0.5|Standard Error of the Mean|0.67||0.468|2-Sided|95.0|-0.84|1.82|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1685261|NCT01180400|3099924|Superiority or Other||LS mean|0.1|Standard Error of the Mean|0.51||0.832|2-Sided|95.0|-0.89|1.11||Analysis for change in MADRS total score from randomization to Week 9.|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1685262|NCT01180400|3099925|Superiority or Other||Odds Ratio (OR)|0.93|Standard Error of the Mean|0.25||0.783|2-Sided|95.0|0.54|1.58|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.|
1685263|NCT01180400|3099926|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.14||0.964||95.0|-0.28|0.26|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1685264|NCT01180400|3099927|Superiority or Other||LS mean|0.5|Standard Error of the Mean|0.72||0.525|2-Sided|95.0|-0.96|1.89|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1685265|NCT01180400|3099928|Superiority or Other||Odds Ratio (OR)|0.9|Standard Error of the Mean|0.44||0.831|2-Sided|95.0|0.35|2.32|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1685266|NCT01180400|3099929|Superiority or Other||Odds Ratio (OR)|0.87|Standard Error of the Mean|0.31||0.689|2-Sided|95.0|0.43|1.75|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1685267|NCT01180400|3099930|Superiority or Other||Odds Ratio (OR)|1.44|Standard Error of the Mean|0.71||0.461|2-Sided|95.0|0.55|3.78|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1685268|NCT01180400|3099931|Superiority or Other||Odds Ratio (OR)|1.45|Standard Error of the Mean|0.41||0.184|2-Sided|95.0|0.84|2.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1685269|NCT01180400|3099932|Superiority or Other||Odds Ratio (OR)|1.01|Standard Error of the Mean|0.26||0.974|2-Sided|95.0|0.61|1.66|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1685270|NCT01180400|3099933|Superiority or Other||LS mean|-0.1|Standard Error of the Mean|0.91||0.944|2-Sided|95.0|-1.86|1.73||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1685271|NCT01180127|3099941|Superiority or Other|||||||0.237|||||||ANCOVA|||ANCOVA was used to test for an exercise effect.|
1685272|NCT01180127|3099942|Superiority or Other|||||||0.581|||||||ANCOVA|||ANCOVA for testing main effect of exercise|
1685273|NCT01180127|3099942|Superiority or Other|||||||0.853|||||||ANCOVA|||ANCOVA for testing main effect of flavanol|
1685274|NCT01180127|3099943|Superiority or Other|||||||0.815||||||The ANCOVA included both a main effect for flavanol and exercise, so this p-value is for the test of exercise controlling for baseline Modbent and flavanol|ANCOVA|||ANCOVA used to test main effect of exercise|
1685275|NCT01180127|3099943|Superiority or Other|||||||0.038||||||The ANCOVA model included a main effect for both flavanol and exercise, so this p-value is for the effect of flavanol on Modbent controlling for baseline Modbent and exercise|ANCOVA|||ANCOVA used to test main effect of flavanol|
1685276|NCT01180127|3099944|Superiority or Other|||||||0.0001|||||||Repeated measures ANOVA|||Repeated measures ANOVA for the interaction of time (baseline vs 12 week) and flavanol group.|
1685277|NCT01180049|3099948|Superiority or Other||Hazard Ratio (HR)|0.646|||||2-Sided|80.0|0.453|0.922|||||||
1685289|NCT01179672|3099966|Superiority or Other|||||||0.193||||||P-value is for ≥75% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.|||
1685290|NCT01179672|3099966|Superiority or Other|||||||0.006||||||P-value is for ≥50% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.|||
1685291|NCT01179672|3099966|Superiority or Other|||||||0.014||||||P-value is for ≥30% reduction in 24-hour average pain.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was stratified by pooled investigator.|||
1685292|NCT01179672|3099967|Superiority or Other||Mean Difference (Final Values)|-1.12||||0.022|2-Sided|95.0|-2.07|-0.16|||ANCOVA|ANCOVA adjusted for treatment, pooled investigator and baseline.|||
1685293|NCT01179672|3099968|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.034|2-Sided|95.0|-0.4|-0.02|||Mixed Models Analysis||||
1685294|NCT01179672|3099969|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.081|2-Sided|95.0|-0.48|0.03|||Mixed Models Analysis||||
1685295|NCT01179672|3099970|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.016|2-Sided|95.0|-0.9|-0.09|||Mixed Models Analysis||||
1685296|NCT01179672|3099971|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.017|2-Sided|95.0|-1.0|-0.1||P-value is for mean change from baseline to 12 week endpoint in worst pain.|Mixed Models Analysis||||
1685297|NCT01179672|3099971|Superiority or Other||Mean Difference (Final Values)|-0.54||||0.008|2-Sided|95.0|-0.95|-0.14||P-value is for mean change from baseline to 12-week endpoint in night pain.|Mixed Models Analysis||||
1685298|NCT01179672|3099972|Superiority or Other||Mean Difference (Final Values)|-0.43||||0.03|2-Sided|95.0|-0.82|-0.04|||Mixed Models Analysis||||
1685299|NCT01179568|3099973|Superiority or Other||Mean Difference (Final Values)|-4.13|Standard Error of the Mean|1.46||0.005|2-Sided||||||Regression, Linear|||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, & race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|
1685300|NCT01179568|3099973|Superiority or Other||Mean Difference (Final Values)|1.2|Standard Error of the Mean|1.44||0.4|2-Sided||||||Regression, Linear|||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, & race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|
1685301|NCT01179568|3099974|Superiority or Other||Mean Difference (Final Values)|-0.84|Standard Error of the Mean|1.57||0.59|2-Sided|||||Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, & race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear||||
1685302|NCT01179568|3099975|Superiority or Other||Mean Difference (Final Values)|-7.37|Standard Error of the Mean|2.08|<|0.001|2-Sided|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, & race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear||||
1685303|NCT01179568|3099975|Superiority or Other||Mean Difference (Final Values)|1.26|Standard Error of the Mean|1.98|<|0.53|2-Sided|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, & race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear||||
1685304|NCT01179568|3099976|Superiority or Other||Mean Difference (Final Values)|0.67|Standard Error of the Mean|2.04||0.74|2-Sided|||||Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, & race/ethnicity, and with inverse probability weighting to adjust for missing assessments.|Regression, Linear||||
1685305|NCT01179568|3099977|Superiority or Other||Risk Ratio (RR)|1.21|||<|0.05|2-Sided|95.0|1.0|1.46|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) & race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs CIT at week 20 (aim 3) based on the intention-to-treat principle including all randomized participants.|
1685306|NCT01179568|3099977|Superiority or Other||Risk Ratio (RR)|1.01|||<|0.05|2-Sided|95.0|0.88|1.17|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) & race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs PLA with CGT at week 20 (aim 2) based on the intention-to-treat principle including all randomized participants.|
1685307|NCT01179568|3099977|Superiority or Other||Risk Ratio (RR)|1.21|||<|0.05|2-Sided|95.0|0.82|1.81|||Regression, Logistic|Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) & race/ethnicity||Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants. With 10% of 440 target enrollment lost to follow-up we had a power of 76-83% to detect predicted between-group difference in response (CGT with PLA, 40%; CGT with CIT, 60%; CIT 40%; and PLA 20%)|
1685308|NCT01179516|3099978|Superiority or Other||LS Mean Difference|0.69|Standard Error of the Mean|1.322||0.6|2-Sided|95.0|-1.91|3.3|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.|||
1685309|NCT01179516|3099978|Superiority or Other||LS Mean Difference|-0.92|Standard Error of the Mean|1.25||0.464|2-Sided|95.0|-3.38|1.55|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.|||
1685310|NCT01179516|3099979|Superiority or Other||Odds Ratio (OR)|1.116||||0.694|2-Sided|95.0|0.646|1.928|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS total score.|||
1685311|NCT01179516|3099979|Superiority or Other||Odds Ratio (OR)|1.291||||0.352|2-Sided|95.0|0.754|2.211|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS total score.|||
1685369|NCT01178333|3100098|Superiority or Other|||||||0.37||||||P-value is to compare three groups.|Chi-squared||||
1685370|NCT01178333|3100099|Superiority or Other|||||||0.72||||||P-value is to compare three groups.|Chi-squared||||
1685312|NCT01179516|3099980|Superiority or Other||LS Mean Difference|1.73|Standard Error of the Mean|2.295||0.451|2-Sided|95.0|-2.8|6.26|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.|||
1685313|NCT01179516|3099980|Superiority or Other||LS Mean Difference|-0.97|Standard Error of the Mean|2.261||0.67|2-Sided|95.0|-5.43|3.5|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.|||
1685314|NCT01179516|3099981|Superiority or Other||LS Mean Difference|-0.05|Standard Error of the Mean|0.151||0.739|2-Sided|95.0|-0.35|0.25|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.|||
1685315|NCT01179516|3099981|Superiority or Other||LS Mean Difference|-0.09|Standard Error of the Mean|0.149||0.554|2-Sided|95.0|-0.38|0.21|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.|||
1685316|NCT01179516|3099982|Superiority or Other||Odds Ratio (OR)|1.212||||0.435|2-Sided|95.0|0.748|1.963|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1685317|NCT01179516|3099982|Superiority or Other||Odds Ratio (OR)|1.232||||0.396|2-Sided|95.0|0.761|1.995|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1685318|NCT01179516|3099983|Superiority or Other||LS Mean Difference|-0.49|Standard Error of the Mean|1.501||0.745|2-Sided|95.0|-3.44|2.46||Pre-specified sequential statistical testing procedure indicates that when p-value >0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.|||
1685319|NCT01179516|3099983|Superiority or Other||LS Mean Difference|-0.79|Standard Error of the Mean|1.488||0.597|2-Sided|95.0|-3.71|2.14||Pre-specified sequential statistical testing procedure indicates that when p-value >0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure for each dose was applied to compare 10 mg and 15 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.|
1685320|NCT01179347|3100006|Superiority or Other||Odds Ratio (OR)|1.092||||0.84||95.0|0.453|2.633||Two-sided p-value.|Regression, Logistic|Adjusted for treatment, age group, baseline weight and baseline FEV1 percent predicted.|Tio R5 qd versus Placebo.||
1685321|NCT01179347|3100007|Superiority or Other||Mean Difference (Final Values)|0.86|Standard Error of the Mean|1.76||0.62||95.0|-2.59|4.32||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.||
1685322|NCT01179347|3100008|Superiority or Other||Mean Difference (Final Values)|1.2|Standard Error of the Mean|0.93||0.19||95.0|-0.62|3.02||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.||
1685323|NCT01179347|3100009|Superiority or Other||Mean Difference (Final Values)|1.09|Standard Error of the Mean|0.9||0.23||95.0|-0.68|2.86||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.||
1685324|NCT01179347|3100010|Superiority or Other||Mean Difference (Final Values)|1.4|Standard Error of the Mean|0.97||0.15||95.0|-0.5|3.3||Two-sided p-value.|Mixed Models Analysis|REML-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|Hierarchical testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful,|
1685325|NCT01179347|3100011|Superiority or Other||Mean Difference (Final Values)|1.64|Standard Error of the Mean|0.97||0.092||95.0|-0.27|3.55||Two-sided p-value.|Mixed Models Analysis|Restricted maximum likelihood (REML)-based MMRM. Adjusted for treatment, visit, treatment-by-visit, age group, baseline and baseline-by-visit.|Tio R5 qd minus Placebo.|Hierarchical testing procedure was applied for both co-primary endpoints to maintain the overall alpha level. If and only if statistical superiority of the Tio R5 qd compared to Placebo in FEV1 AUC0-4h was demonstrated at the 1 sided alpha level of 0.025, confirmatory comparison in the second co-primary endpoint, at the same alpha level of 0.025 could be done .|
1685326|NCT01179217|3100031|Superiority or Other|||||||0.0888|||||||Cochran-Mantel-Haenszel||||
1685327|NCT01179217|3100032|Superiority or Other|||||||0.0045|||||||Cochran-Mantel-Haenszel||||
1685328|NCT01179217|3100033|Superiority or Other||Wilcoxon rank-sum test|0.5||||0.0052|2-Sided|||||"The primary analysis was analyzed using a CMH analysis of the number of SCCs using modified ridit scores.~P-value (controlling for region and HU use)~The null hypothesis of the final analysis was performed at the 0.045 significance level."|Cochran-Mantel-Haenszel||||
1685329|NCT01179048|3100051|Superiority or Other||Hazard Ratio (HR)|1.454|||||2-Sided|95.0|0.845|2.502||||||Analysis for percentage of subjects experiencing vitreous haemorrhage was done by Cox regression model with treatment as fixed factor.|
1685330|NCT01179048|3100051|Superiority or Other||Hazard Ratio (HR)|0.335|||||2-Sided|95.0|0.004|30.847||||||Analysis for percentage of subjects experiencing development of diabetes-related blindness was done by Cox regression model with treatment as fixed factor.|
1685331|NCT01179048|3100051|Superiority or Other||Hazard Ratio (HR)|1.159|||||2-Sided|95.0|0.869|1.546||||||Analysis for percentage of subjects experiencing treatment with photocoagulation or intravitreal agents was done by Cox regression model with treatment as fixed factor.|
1685332|NCT01179048|3100051|Superiority or Other||Hazard Ratio (HR)|1.149|||||2-Sided|95.0|0.869|1.519||||||Analysis for percentage of subjects experiencing composite retinopathy was done by Cox regression model with treatment as fixed factor.|
1685333|NCT01179048|3100051|Superiority or Other||Hazard Ratio (HR)|1.593|||||2-Sided|95.0|0.521|4.869||||||Analysis for percentage of subjects experiencing death due to renal disease was done by Cox regression model with treatment as fixed factor.|
1685334|NCT01179048|3100051|Superiority or Other||Hazard Ratio (HR)|0.869|||||2-Sided|95.0|0.607|1.244||||||Analysis for percentage of subjects experiencing a need for continuous renal-replacement therapy was done by Cox regression model with treatment as fixed factor.|
1685335|NCT01179048|3100051|Superiority or Other||Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.667|1.189||||||Analysis for percentage of subjects experiencing persistent doubling of serum creatinine was done by Cox regression model with treatment as fixed factor.|
1685336|NCT01179048|3100051|Superiority or Other||Hazard Ratio (HR)|0.738|||||2-Sided|95.0|0.602|0.905||||||Analysis for percentage of subjects experiencing a new onset of persistant macroalbuminaria event was done by Cox regression model with treatment as fixed factor.|
1685337|NCT01179048|3100051|Superiority or Other||Hazard Ratio (HR)|0.782|||||2-Sided|95.0|0.666|0.918||||||Analysis for percentage of subjects experiencing a composite nephropathy event was done by Cox regression model with treatment as fixed factor.|
1685338|NCT01179048|3100052|Superiority or Other||Hazard Ratio (HR)|0.841|||||2-Sided|95.0|0.73|0.969||||||Analysis for percentage of subjects experiencing a first microvascular event was done by Cox regression model with treatment as fixed factor.|
1685339|NCT01179048|3100053|Superiority or Other||Hazard Ratio (HR)|0.872|||||2-Sided|95.0|0.727|1.046||||||Analysis for percentage of subjects experiencing hospitalisation for heart failure was done by Cox regression model with treatment as fixed factor|
1685340|NCT01179048|3100053|Superiority or Other||Hazard Ratio (HR)|0.912|||||2-Sided|95.0|0.797|1.044||||||Analysis for percentage of subjects experiencing coronary revascularisation was done by Cox regression model with treatment as fixed factor|
1685341|NCT01179048|3100053|Superiority or Other||Hazard Ratio (HR)|0.98|||||2-Sided|95.0|0.763|1.258||||||Analysis for percentage of subjects experiencing hospitalisation for unstable angina pectoris was done by Cox regression model with treatment as fixed factor|
1685342|NCT01179048|3100053|Superiority or Other||Hazard Ratio (HR)|0.878|||||2-Sided|95.0|0.747|1.031||||||Analysis for percentage of subjects experiencing non-fatal myocardial infarction was done by Cox regression model with treatment as fixed factor|
1685343|NCT01179048|3100053|Superiority or Other||Hazard Ratio (HR)|0.894|||||2-Sided|95.0|0.721|1.107||||||Analysis for percentage of subjects experiencing non-fatal stroke was done by Cox regression model with treatment as fixed factor|
1685344|NCT01179048|3100053|Superiority or Other||Hazard Ratio (HR)|0.783|||||2-Sided|95.0|0.656|0.934||||||Analysis for percentage of subjects experiencing cardiovascular death was done by Cox regression model with treatment as fixed factor.|
1685345|NCT01179048|3100054|Superiority or Other||Hazard Ratio (HR)|0.847|||||2-Sided|95.0|0.739|0.971|||||||
1685346|NCT01179048|3100055|Superiority or Other||Hazard Ratio (HR)|0.881|||||2-Sided|95.0|0.807|0.962|||||||
1685347|NCT01179048|3100056|Superiority or Other||Hazard Ratio (HR)|0.868||||0.005|2-Sided|95.0|0.778|0.968||p-value is reported for one-sided (α-level 0.025) test for superiority (hazard ratio>=1.0).|Regression, Cox|||If non-inferiority was established for the primary outcome, a test for superiority was performed. Superiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.0 or equivalent if the p-value for the one-sided test of H0: HR >=1.0 against Ha: HR <1.0 was less than 2.5% (or equivalent to 5% in two-sided test).|
1685348|NCT01179048|3100056|Non-Inferiority or Equivalence|Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR >=1.3 against Ha: HR <1.3 was less than 2.5% (or equivalent to 5% in two-sided test). If non-inferiority was established for the primary outcome, a test for superiority was to be performed.|Hazard Ratio (HR)|0.868|||<|0.001|2-Sided|95.0|0.778|0.968||p-value is reported for one-sided (α-level 0.025) test for non-inferiority (hazard ratio >=1.3).|Regression, Cox|||The primary endpoint was evaluated using the Cox regression model to estimate the hazard ratio (HR) (liraglutide/placebo) and the 2-sided 95% confidence interval (CI) including treatment group as factor. Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.3 or if the p-value for the one-sided test of H0: HR >=1.3 against Ha: HR <1.3 was less than 2.5% (or equivalent to 5% in two-sided test).|
1685349|NCT01178944|3100057|Other||Mean Difference (Final Values)|1.08||||0.585|2-Sided|95.0|0.78|1.38|||t-test, 2 sided|||Comparison is CR+PR vs stable disease/progression|
1685350|NCT01178671|3100073|Superiority or Other|||||||0.65|||||||Mixed Models Analysis||||
1685351|NCT01178671|3100074|Superiority or Other|||||||0.21|||||||Mixed Models Analysis||||
1685352|NCT01178671|3100075|Superiority or Other|||||||0.14|||||||Chi-squared||||
1685353|NCT01178671|3100076|Superiority or Other||Odds Ratio (OR)|4.7||||0.042|2-Sided|95.0|1.1|19.9|||Mixed Models Analysis||||
1685354|NCT01178671|3100077|Superiority or Other||Odds Ratio (OR)|1.8||||0.31|2-Sided||||||Mixed Models Analysis||||
1685355|NCT01178671|3100078|Superiority or Other|||||||0.023|||||||Mixed Models Analysis||||
1685356|NCT01178671|3100079|Superiority or Other|||||||0.5|||||||t-test, 2 sided||||
1685357|NCT01178671|3100080|Superiority or Other|||||||0.14|||||||t-test, 2 sided||||
1685358|NCT01178671|3100081|Superiority or Other|||||||0.82|||||||t-test, 2 sided||||
1685359|NCT01178671|3100082|Superiority or Other|||||||0.17|||||||Mixed Models Analysis||||
1685360|NCT01178333|3100090|Superiority or Other||Hazard Ratio (HR)|0.82||||0.34|2-Sided|95.0|0.54|1.24|||Regression, Cox||||
1685361|NCT01178333|3100090|Superiority or Other||Hazard Ratio (HR)|0.92||||0.72|2-Sided|95.0|0.56|1.49|||Regression, Cox||||
1685362|NCT01178333|3100091|Superiority or Other||||||<|0.01||||||P-value is to compare three groups.|Chi-squared||||
1685363|NCT01178333|3100093|Superiority or Other||Hazard Ratio (HR)|1.66||||0.07|2-Sided|95.0|0.96|2.85|||Regression, Cox||||
1685364|NCT01178333|3100093|Superiority or Other||Hazard Ratio (HR)|2.48||||0.003|2-Sided|95.0|1.35|4.55|||Regression, Cox||||
1685365|NCT01178333|3100094|Superiority or Other||||||<|0.01||||||P-value is to compare three groups.|Chi-squared||||
1685366|NCT01178333|3100095|Superiority or Other|||||||0.66|||||||Regression, Cox||||
1685367|NCT01178333|3100096|Superiority or Other|||||||0.58|||||||ANOVA||||
1685368|NCT01178333|3100097|Superiority or Other|||||||0.02||||||P-value is to compare three groups.|Chi-squared||||
1685371|NCT01178333|3100102|Superiority or Other||Hazard Ratio (HR)|1.97||||0.02|2-Sided|95.0|1.12|3.45|||Regression, Cox||||
1685372|NCT01178333|3100102|Superiority or Other||Hazard Ratio (HR)|2.8||||0.001|2-Sided|95.0|1.5|5.22|||Regression, Cox||||
1685373|NCT01178333|3100103|Superiority or Other||Hazard Ratio (HR)|1.91||||0.11|2-Sided|95.0|0.87|4.21|||Regression, Cox||||
1685374|NCT01178333|3100103|Superiority or Other||Hazard Ratio (HR)|2.38||||0.06|2-Sided|95.0|0.98|5.79|||Regression, Cox||||
1685375|NCT01178333|3100104|Superiority or Other||Hazard Ratio (HR)|1.35||||0.78|2-Sided|95.0|0.16|11.25|||Regression, Cox||||
1685376|NCT01178333|3100104|Superiority or Other||Hazard Ratio (HR)|4.76||||0.15|2-Sided|95.0|0.55|40.87|||Regression, Cox||||
1685377|NCT01178333|3100106|Superiority or Other||Hazard Ratio (HR)|1.31||||0.45|2-Sided|95.0|0.65|2.66|||Regression, Cox||||
1685378|NCT01178333|3100106|Superiority or Other||Hazard Ratio (HR)|1.98||||0.09|2-Sided|95.0|0.9|4.36|||Regression, Cox||||
1685379|NCT01178294|3100124|Superiority or Other||||||<|0.001|||||||one-sided binomial exact test|||Summary statistics for the percentage of participants with serious bleeding episodes responsive at 24 hours after the initiation of treatment are presented, along with the 95% confidence interval (two-sided 95% Clopper-Pearson confidence interval).|
1685380|NCT01178281|3100132|Other|||||||0.929|||||||Log Rank||||
1685381|NCT01178281|3100134|Other|||||||1|||||||Fisher Exact||||
1685382|NCT01178099|3100264|Superiority or Other|||||||0.124||||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error.|ANCOVA||||
1685383|NCT01178099|3100265|Superiority or Other|||||||0.083||||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error.|ANCOVA||||
1685384|NCT01178099|3100266|Superiority or Other|||||||0.086||||||This is the p-value for AU*min to TRAP-6. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error.|ANCOVA||||
1685385|NCT01178099|3100266|Superiority or Other|||||||0.095||||||This is the p-value for AU*min to Collagen. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error.|ANCOVA||||
1685386|NCT01178099|3100266|Superiority or Other|||||||0.288||||||This is the p-value for AU*min to 20 µM ADP. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error.|ANCOVA||||
1685387|NCT01178099|3100266|Superiority or Other|||||||0.396||||||This is the p-value for AU*min to 6.5 µM ADP. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error.|ANCOVA||||
1685388|NCT01178099|3100267|Superiority or Other|||||||0.679||||||This is the p-value for PRI by ELISA. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error|ANCOVA||||
1685389|NCT01178099|3100267|Superiority or Other|||||||0.086||||||This is the p-value for PRI by flow cytometry. The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error|ANCOVA||||
1685390|NCT01178099|3100268|Superiority or Other|||||||0.06||||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error.|ANCOVA||||
1685391|NCT01178099|3100269|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|1.0|||||2-Sided|90.0|0.648|1.55|||||This is the estimated value for 5 mg MD for the R-119251 metabolite.||
1685392|NCT01178099|3100269|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|0.785|||||2-Sided|90.0|0.582|1.06|||||This is the estimated value for 7.5 mg MD for the R-119251 metabolite.||
1685393|NCT01178099|3100269|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|1.06|||||2-Sided|90.0|0.773|1.46|||||This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite.||
1685394|NCT01178099|3100269|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|0.898|||||2-Sided|90.0|0.612|1.32|||||This is the estimated value for 5 mg MD for the R-106583 metabolite.||
1685395|NCT01178099|3100269|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|0.681|||||2-Sided|90.0|0.524|0.886|||||This is the estimated value for 7.5 mg MD for the R-106583 metabolite.||
1685396|NCT01178099|3100269|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|0.873|||||2-Sided|90.0|0.66|1.15|||||This is the estimated value for 10 mg SD (overall) for the R-106583 metabolite.||
1685397|NCT01178099|3100269|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|1.87|||||2-Sided|90.0|1.09|3.2|||||This is the estimated value for 5 mg MD for the R-95913 metabolite.||
1685398|NCT01178099|3100269|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|1.09|||||2-Sided|90.0|0.751|1.58|||||This is the estimated value for 7.5 mg MD for the R-95913 metabolite.||
1685399|NCT01178099|3100269|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|1.5|||||2-Sided|90.0|1.01|2.22|||||This is the estimated value for 10 mg SD (overall) for the R-95913 metabolite.||
1685400|NCT01178099|3100270|Superiority or Other|||||||0.168||||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error.|ANCOVA||||
1685401|NCT01178099|3100271|Superiority or Other|||||||0.177||||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error.|ANCOVA||||
1685402|NCT01178099|3100272|Superiority or Other|||||||0.219||||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error.|ANCOVA||||
1685403|NCT01178099|3100273|Superiority or Other|||||||0.06||||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error.|ANCOVA||||
1685404|NCT01178099|3100274|Superiority or Other|||||||0.018||||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error.|ANCOVA||||
1685405|NCT01178099|3100275|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|0.813|||||2-Sided|95.0|0.51|1.3|||||This is the estimated value for 5 mg MD for the R-119251 metabolite.||
1685406|NCT01178099|3100275|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|1.07|||||2-Sided|90.0|0.779|1.48|||||This is the estimated value for 7.5 mg MD for the R-119251 metabolite.||
1685663|NCT01174446|3100757|Superiority or Other|||||||0.0633|||||||Paired t-test||||
1685407|NCT01178099|3100275|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|1.17|||||2-Sided|90.0|0.833|1.65|||||This is the estimated value for 10 mg SD (overall) for the R-119251 metabolite.||
1685408|NCT01178099|3100275|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|0.952|||||2-Sided|90.0|0.658|1.38|||||This is the estimated value for the 5 mg MD for the R-106583 metabolite.||
1685409|NCT01178099|3100275|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|0.815|||||2-Sided|90.0|0.633|1.05|||||This is the estimated value for the 7.5 mg MD for the R-106583 metabolite.||
1685410|NCT01178099|3100275|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|0.971|||||2-Sided|90.0|0.742|1.27|||||This is the estimated value for the 10 mg SD (overall) for the R-106583 metabolite.||
1685411|NCT01178099|3100275|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|1.43|||||2-Sided|90.0|0.918|2.21|||||This is the estimated value for 5 mg MD for the R-95913 metabolite.||
1685412|NCT01178099|3100275|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|1.44|||||2-Sided|90.0|1.06|1.94|||||This is the estimated value for 7.5 mg MD for the R-95913 metabolite.||
1685413|NCT01178099|3100275|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|1.52|||||2-Sided|90.0|1.1|2.1|||||This is the estimated value for 10 mg SD (overall) for the R-95913 metabolite.||
1685414|NCT01178099|3100276|Superiority or Other|||||||0.07||||||The p-value is from model: Change from Baseline = Baseline + Treatment + Population + Treatment*Population + Random Error.|ANCOVA||||
1685415|NCT01178099|3100277|Superiority or Other||Geometric LS Means, SCD:Healthy|1.03|||||2-Sided|90.0|0.625|1.68|||||This is the estimated value for 5 mg MD.||
1685416|NCT01178099|3100277|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|0.612|||||2-Sided|90.0|0.436|0.86|||||This is the estimated value for the 7.5 mg MD.||
1685417|NCT01178099|3100277|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|0.953|||||2-Sided|90.0|0.664|1.37|||||This is the estimated value for the 10 mg SD (overall).||
1685418|NCT01178099|3100278|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|0.905|||||2-Sided|90.0|0.656|1.25|||||This is the estimated value for the 5 mg MD.||
1685419|NCT01178099|3100278|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|0.895|||||2-Sided|90.0|0.718|1.12|||||This is the estimated value for the 7.5 mg MD.||
1685420|NCT01178099|3100278|Superiority or Other||Ratio of Geometric LS Means, SCD:Healthy|1.05|||||2-Sided|90.0|0.829|1.33|||||This is the estimated value for the 10 mg SD (overall).||
1685421|NCT01178073|3100289|Superiority or Other||Median Difference|-0.5|||||2-Sided|95.0|-1.0|0.0|||||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.||
1685422|NCT01178073|3100289|Superiority or Other||Median Difference|-0.5|||||2-Sided|95.0|-1.0|0.0|||||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.||
1685423|NCT01178073|3100289|Superiority or Other||Median Difference|-0.38|||||2-Sided|95.0|-0.75|0.0|||||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.||
1685424|NCT01178073|3100290|Superiority or Other||Median Difference|0.0|||||2-Sided|95.0|0.0|0.0|||||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.||
1685425|NCT01178073|3100290|Superiority or Other||Median Difference|0.0|||||2-Sided|95.0|0.0|0.0|||||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.||
1685426|NCT01178073|3100290|Superiority or Other||Median Difference|0.0||||0.2287|2-Sided|95.0|0.0|0.0|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.||
1685427|NCT01178073|3100291|Superiority or Other||Median Difference|20.85||||0.003|2-Sided|95.0|8.0|33.7|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.||
1685428|NCT01178073|3100291|Superiority or Other||Median Difference|24.75||||0.0005|2-Sided|95.0|11.0|38.5|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.||
1685429|NCT01178073|3100291|Superiority or Other||Median Difference|22.75|||<|0.0001|2-Sided|95.0|12.0|33.5|||Stratified Wilcoxon Rank Sum Test||Median difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.||
1685430|NCT01178073|3100292|Superiority or Other||Odds Ratio (OR)|1.723||||0.0321|2-Sided|95.0|1.047|2.833|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Tadalafil Monotherapy.||
1685431|NCT01178073|3100292|Superiority or Other||Odds Ratio (OR)|1.424||||0.1518|2-Sided|95.0|0.878|2.308|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Ambrisentan Monotherapy.||
1685432|NCT01178073|3100292|Superiority or Other||Odds Ratio (OR)|1.563||||0.0264|2-Sided|95.0|1.054|2.319|||Regression, Logistic||Odds ratio is for Combination Therapy: Ambrisentan + Tadalafil / Monotherapy Pooled: Ambrisentan or Tadalafil.||
1685433|NCT01178073|3100293|Superiority or Other||Mean Percent Difference|-41.51|||<|0.0001|2-Sided|95.0|-53.16|-26.97|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Tadalafil Monotherapy.||
1685434|NCT01178073|3100293|Superiority or Other||Mean Percent Difference|-25.09|||<|0.0111|2-Sided|95.0|-40.04|-6.4|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Ambrisentan Monotherapy.||
1685435|NCT01178073|3100293|Superiority or Other||Mean Percent Difference|-33.81|||<|0.0001|2-Sided|95.0|-44.78|-20.66|||ANCOVA||Mean percent difference is for Combination Therapy: Ambrisentan + Tadalafil - Monotherapy Pooled: Ambrisentan or Tadalafil.||
1685436|NCT01178073|3100294|Superiority or Other||Hazard Ratio (HR)|0.528||||0.0045|2-Sided|95.0|0.338|0.827|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Tadalafil Monotherapy.||
1685437|NCT01178073|3100294|Superiority or Other||Hazard Ratio (HR)|0.477||||0.0004|2-Sided|95.0|0.314|0.723|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Ambrisentan Monotherapy.||
1685508|NCT01176968|3100393|Superiority or Other|||||||0.0865|||||||Wilcoxon Rank-Sum test|||For Biomarker- PINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.|
1685438|NCT01178073|3100294|Superiority or Other||Hazard Ratio (HR)|0.502||||0.0002|2-Sided|95.0|0.348|0.724|||Stratified Log Rank||Analysis of time to first adjudicated clinical failure event through FAV. HR is calculated using the Cox proportional hazards model. HR is for Combination Therapy: Ambrisentan + Tadalafil / Monotherapy Pooled: Ambrisentan or Tadalafil.||
1685439|NCT01177969|3100295|Superiority or Other|||||||0.25||||||This analysis applies to the post-treatment assessment (16 weeks after baseline)|ANCOVA||||
1685440|NCT01177969|3100296|Superiority or Other|||||||0.04||||||This analysis applies to the post-treatment assessment (16 weeks after baseline)|ANCOVA||||
1685441|NCT01177943|3100306|Non-Inferiority or Equivalence|80-125% was used for bioequivalence (BE) criteria in terms of the ratio of geometric means.|Ratio of AUC(0-tlast) values|1.03|||||2-Sided|90.0|1.0|1.07|||||||
1685442|NCT01177943|3100307|Non-Inferiority or Equivalence|80-125% was used for bioequivalence (BE) criteria in terms of geometric means.|Ratio of Geometric LS Mean values|0.945|||||2-Sided|90.0|0.858|1.04|||||||
1685443|NCT01177813|3100309|Superiority or Other||Mean Difference (Final Values)|-1.5|Standard Error of the Mean|0.7||0.0296|2-Sided|97.5|-3.0|0.0||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||"Comparison for diastolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate"|
1685444|NCT01177813|3100309|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.7||0.3987|2-Sided|97.5|-2.1|0.9||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||"Comparison for diastolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline DBP and baseline HbA1c as linear covariate"|
1685445|NCT01177813|3100309|Superiority or Other||Mean Difference (Final Values)|-3.4|Standard Error of the Mean|1.1||0.0028|2-Sided|97.5|-6.0|-0.9||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||"Comparison for Systolic blood pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate"|
1685446|NCT01177813|3100309|Superiority or Other||Mean Difference (Final Values)|-2.6|Standard Error of the Mean|1.1||0.0231|2-Sided|97.5|-5.2|0.0||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||"Comparison for Systolic Blood Pressure~Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, baseline SBP and baseline HbA1c as linear covariate"|
1685447|NCT01177813|3100310|Superiority or Other||Mean Difference (Final Values)|-2.15|Standard Error of the Mean|0.24|<|0.0001|2-Sided|95.0|-2.7|-1.6||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate|
1685448|NCT01177813|3100310|Superiority or Other||Mean Difference (Final Values)|-1.93|Standard Error of the Mean|0.24|<|0.0001|2-Sided|97.5|-2.48|-1.38||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region,and renal function at baseline as fixed effects,baseline body weight and baseline HbA1c as linear covariate|
1685449|NCT01177813|3100311|Superiority or Other||Mean Difference (Final Values)|-0.85|Standard Error of the Mean|0.07|<|0.0001|2-Sided|97.5|-1.01|-0.69||Difference calculated as empagliflozin 25mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate|
1685450|NCT01177813|3100311|Superiority or Other||Mean Difference (Final Values)|-0.74|Standard Error of the Mean|0.07|<|0.0001|2-Sided|97.5|-0.9|-0.57||Difference calculated as empagliflozin 10mg minus placebo|ANCOVA|||Model was adjusted for treatment,geographical region, and renal function at baseline as fixed effects, and baseline HbA1c as linear covariate|
1685451|NCT01177800|3100313|Superiority or Other||||||<|0.001|||||||Non parametric ANOVA by van der Waerden|||Change at Week 26: p-value was calculated by Non parametric ANOVA by van der Waerden method.|
1685452|NCT01177800|3100314|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1685453|NCT01177800|3100315|Superiority or Other||||||<|0.001|||||||Non parametric ANOVA by van der Waerden|||Change at Week 10: p-value was calculated by Non parametric ANOVA by van der Waerden method.|
1685454|NCT01177800|3100316|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1685455|NCT01177410|3100330|Superiority or Other (legacy)||Odds Ratio (OR)|1.148||||0.726|2-Sided|95.0|0.531|2.483|||Proportional Odds Model||||
1685456|NCT01177410|3100330|Superiority or Other (legacy)||Odds Ratio (OR)|2.232||||0.0327|2-Sided|95.0|1.068|4.664|||Proportional Odds Model|||Proportional odds model was used to compare the number of months the subjects are responders.|
1685457|NCT01177410|3100331|Superiority or Other (legacy)||Odds Ratio (OR)|1.267||||0.6059|2-Sided|95.0|0.515|3.115|||Regression, Logistic||||
1685458|NCT01177410|3100331|Superiority or Other (legacy)||Odds Ratio (OR)|2.369||||0.0432|2-Sided|95.0|1.027|5.467|||Regression, Logistic||||
1685459|NCT01177384|3100334|Superiority or Other||Difference in least squares mean|-14.4|||<|0.001|2-Sided|95.0|-21.8|-7.0||The ANCOVA model included terms for treatment and prior AHA therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline FPG.|ANCOVA||||
1685460|NCT01177384|3100335|Superiority or Other||Difference in least squares mean|-0.62|||<|0.001|2-Sided|95.0|-0.79|-0.44||The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (on acarbose monotherapy, or on acarbose in combination with other AHA(s)) and a covariate for baseline A1C.|ANCOVA||||
1685461|NCT01177293|3100338|Non-Inferiority or Equivalence|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric means ratio|86.67|||||2-Sided|90.0|79.57|94.42||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1278 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.|
1685509|NCT01176968|3100393|Superiority or Other|||||||0.0295|||||||Signed Rank Test|||For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685462|NCT01177293|3100339|Non-Inferiority or Equivalence|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric mean ratio|99.73|||||2-Sided|90.0|85.1|116.87|||||||
1685463|NCT01177293|3100340|Non-Inferiority or Equivalence|Natural log transformed AUC[0- ∞] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted geometric means ratio|89.78|||||2-Sided|90.0|82.74|97.43||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1155 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.|
1685464|NCT01177137|3100353|Superiority||Slope|-0.62|Standard Error of the Mean|0.58||0.29|2-Sided|95.0|-1.75|0.52||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685465|NCT01177137|3100353|Superiority||Slope|0.61|Standard Error of the Mean|0.59||0.3|2-Sided|95.0|0.55|1.78||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685466|NCT01177137|3100354|Superiority||Slope|-1.04|Standard Error of the Mean|0.91||0.26|2-Sided|95.0|-2.83|0.75||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685467|NCT01177137|3100354|Superiority||Slope|0.34|Standard Error of the Mean|0.96||0.72|2-Sided|95.0|-1.54|2.23||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685468|NCT01177137|3100355|Superiority||Slope|-2.81|Standard Error of the Mean|1.22||0.022|2-Sided|95.0|-5.21|-0.41||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685469|NCT01177137|3100355|Superiority||Slope|-0.82|Standard Error of the Mean|1.27||0.52|2-Sided|95.0|-3.3|1.66||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685470|NCT01177137|3100356|Superiority||Slope|-3.52|Standard Error of the Mean|2.93||0.23|2-Sided|95.0|-9.26|2.23||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685471|NCT01177137|3100356|Superiority||Slope|1.24|Standard Error of the Mean|3.01||0.68|2-Sided|95.0|-4.67|7.14||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685472|NCT01177137|3100357|Superiority||Slope|-3.02|Standard Error of the Mean|3.27||0.36|2-Sided|95.0|-9.43|3.4||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685473|NCT01177137|3100357|Superiority||Slope|-0.13|Standard Error of the Mean|3.39||0.97|2-Sided|95.0|-6.78|6.52||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685474|NCT01177137|3100358|Superiority||Slope|-4.46|Standard Error of the Mean|3.58||0.21|2-Sided|95.0|-11.48|2.55||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685475|NCT01177137|3100358|Superiority||Slope|-1.85|Standard Error of the Mean|3.69||0.62|2-Sided|95.0|-9.07|5.38||The a priori threshold for statistical significance was < 0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685664|NCT01174446|3100758|Superiority or Other|||||||0.5|||||||Paired t-test||||
1685476|NCT01177137|3100359|Superiority||Slope|-0.23|Standard Error of the Mean|3.82||0.95|2-Sided|95.0|-7.72|7.26||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685477|NCT01177137|3100359|Superiority||Slope|3.71|Standard Error of the Mean|3.91||0.34|2-Sided|95.0|-3.96|11.38||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685478|NCT01177137|3100360|Superiority||Slope|-13.7|Standard Error of the Mean|4.24||0.001|2-Sided|95.0|-22.02|-5.38||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685479|NCT01177137|3100360|Superiority||Slope|-3.53|Standard Error of the Mean|4.47||0.43|2-Sided|95.0|-12.3|5.23||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685480|NCT01177137|3100361|Superiority||Slope|0.94|Standard Error of the Mean|3.26||0.77|2-Sided|95.0|-5.44|7.33||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685481|NCT01177137|3100361|Superiority||Slope|1.41|Standard Error of the Mean|3.37||0.68|2-Sided|95.0|-5.2|8.02||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685482|NCT01177137|3100362|Superiority||Slope|3.29|Standard Error of the Mean|3.19||0.3|2-Sided|95.0|-2.96|9.54||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685483|NCT01177137|3100362|Superiority||Slope|3.12|Standard Error of the Mean|3.34||0.35|2-Sided|95.0|-3.44|9.68||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685484|NCT01177137|3100363|Superiority||Slope|-0.91|Standard Error of the Mean|2.98||0.76|2-Sided|95.0|-6.75|4.93||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685485|NCT01177137|3100363|Superiority||Slope|-3.19|Standard Error of the Mean|3.1||0.3|2-Sided|95.0|-9.27|2.88||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685486|NCT01177137|3100364|Superiority||Slope|-0.2|Standard Error of the Mean|0.34||0.55|2-Sided|95.0|-0.86|0.46||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685487|NCT01177137|3100364|Superiority||Slope|-0.07|Standard Error of the Mean|0.39||0.85|2-Sided|95.0|-0.83|0.69||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685488|NCT01177137|3100365|Superiority||Slope|-0.87|Standard Error of the Mean|0.35||0.015|2-Sided|95.0|-1.56|-0.17||The a priori threshold for statistical significance was < 0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685489|NCT01177137|3100365|Superiority||Slope|-0.1|Standard Error of the Mean|0.32||0.75|2-Sided|95.0|-0.74|0.53||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685510|NCT01176968|3100393|Superiority or Other|||||||0.1723|||||||Signed Rank Test|||For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685511|NCT01176968|3100393|Superiority or Other|||||||0.0293|||||||Wilcoxon Rank-Sum test|||For Biomarker- Galecting 3, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.|
1685490|NCT01177137|3100366|Superiority|The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|Slope|-0.36|Standard Error of the Mean|0.51||0.48|2-Sided|95.0|-1.35|0.64|||repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685491|NCT01177137|3100366|Superiority||Slope|-0.38|Standard Error of the Mean|0.51||0.46|2-Sided|95.0|-1.37|0.62||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation.||
1685492|NCT01177137|3100367|Superiority||Slope|-0.12|Standard Error of the Mean|0.52||0.82|2-Sided|95.0|-1.14|0.9||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685493|NCT01177137|3100367|Superiority||Slope|-0.36|Standard Error of the Mean|0.52||0.5|2-Sided|95.0|-1.38|0.67||The a priori threshold for statistical significance was set at <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685494|NCT01177137|3100368|Superiority||Slope|-0.6|Standard Error of the Mean|1.3||0.65|2-Sided|95.0|-3.16|1.96||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685495|NCT01177137|3100368|Superiority||Slope|-0.39|Standard Error of the Mean|1.37||0.77|2-Sided|95.0|-3.08|2.29||The a priori threshold for statistical significance was <0.025 to account for two comparisons (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685496|NCT01177137|3100370|Superiority||Slope|-0.62|Standard Error of the Mean|0.58||0.29|2-Sided|95.0|-1.75|0.52||The a priori threshold for statistical significance was <0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685497|NCT01177137|3100370|Superiority||Slope|0.61|Standard Error of the Mean|0.59||0.3|2-Sided|95.0|-0.55|1.77||The a priori threshold for statistical significance was <0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline THI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685498|NCT01177137|3100371|Superiority||Slope|2.74|Standard Error of the Mean|2.53||0.28|2-Sided|95.0|-2.21|7.7||The a priori threshold for statistical significance was <0.025 to adjust for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685499|NCT01177137|3100371|Superiority||Slope|-0.14|Standard Error of the Mean|2.63||0.96|2-Sided|95.0|-5.3|5.02||The a priori threshold for statistical significance was <0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Ca|repeated measures GEE model||Adjusted for baseline TFI value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685500|NCT01177137|3100372|Superiority||Slope|-2.8|Standard Error of the Mean|2.78||0.31|2-Sided|95.0|-8.27|2.65||The a priori threshold for statistical significance was <0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685501|NCT01177137|3100372|Superiority||Slope|-2.35|Standard Error of the Mean|3.27||0.47|2-Sided|95.0|-8.77|4.07||The a priori threshold for statistical significance was <0.025 to account for two comparisons: (1) TRT versus the Standard of Care and (2) Partial TRT versus the Standard of Care.|repeated measures GEE model||Adjusted for baseline TQ value, clinic, visit, age, gender, baseline Positive and Negative Affect Schedule and State Trait Anxiety Inventory scores, with multiple imputation||
1685502|NCT01176968|3100391|Superiority or Other|||||||0.0801|||||||Wilcoxon Rank-Sum test|||For Biomarker- Interleukin-6, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.|
1685503|NCT01176968|3100391|Superiority or Other||||||<|0.0001|||||||Signed Rank Test|||For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685504|NCT01176968|3100391|Superiority or Other||||||<|0.0001|||||||Signed Rank Test|||For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685505|NCT01176968|3100392|Superiority or Other|||||||0.6459|||||||Wilcoxon Rank-Sum test|||For Biomarker- ICTP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.|
1685506|NCT01176968|3100392|Superiority or Other|||||||0.036|||||||Signed Rank Test|||For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685507|NCT01176968|3100392|Superiority or Other|||||||0.0944|||||||Signed Rank Test|||For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685512|NCT01176968|3100393|Superiority or Other||||||<|0.0001|||||||Signed Rank Test|||For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685513|NCT01176968|3100393|Superiority or Other||||||<|0.0008|||||||Signed Rank Test|||For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685514|NCT01176968|3100393|Superiority or Other||||||<|0.1558|||||||Wilcoxon-Rank Sum test|||For Biomarker- PIIINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.|
1685515|NCT01176968|3100393|Superiority or Other||||||<|0.0001|||||||Signed Rank Test|||For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685516|NCT01176968|3100393|Superiority or Other||||||<|0.0005|||||||Signed Rank Test|||For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685517|NCT01176968|3100394|Superiority or Other|||||||0.3347|||||||Wilcoxon Rank-Sum test|||For Biomarker- Serum Cortisol, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.|
1685518|NCT01176968|3100394|Superiority or Other||||||<|0.0001|||||||Signed Rank Test|||For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685519|NCT01176968|3100394|Superiority or Other||||||<|0.0001|||||||Signed Rank Test|||For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685520|NCT01176968|3100394|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank-Sum test|||For Biomarker- Aldosterone, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.|
1685521|NCT01176968|3100394|Superiority or Other||||||<|0.5552|||||||Signed Rank Test|||For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685522|NCT01176968|3100394|Superiority or Other||||||<|0.0001|||||||Signed Rank Test|||For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.|
1685523|NCT01176968|3100395|Superiority or Other||Mean Difference (Final Values)|0.04||||0.4105|2-Sided|95.0|-0.05|0.13||ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.|ANCOVA|||For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.|
1685524|NCT01176968|3100395|Superiority or Other||Mean Difference (Final Values)|0.02||||0.7123|2-Sided|95.0|-0.1|0.14||ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.|ANCOVA|||For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.|
1685525|NCT01176968|3100396|Superiority or Other||Mean Difference (Final Values)|-1.45||||0.1744|2-Sided|95.0|-3.55|0.65|||ANCOVA|||ANCOVA model was used with observed value as the dependent variable, treatment as a major factor, and baseline QRS duration, baseline eGFR, with/without previous MI, time (in hours) of first dose administered post onset of index symptom, and location of index MI (anterior versus all other locations) as covariates.|
1685526|NCT01176968|3100397|Superiority or Other||Cox Proportional Hazard|1.6||||0.3757|2-Sided|95.0|0.566|4.525|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.|
1685527|NCT01176968|3100398|Superiority or Other||Cox Proportional Hazard|1.069||||0.9353|2-Sided|95.0|0.213|5.371|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.|
1685528|NCT01176968|3100399|Superiority or Other||Cox Proportional Hazard|0.598||||0.0003|2-Sided|95.0|0.452|0.791|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.|
1685529|NCT01176968|3100400|Superiority or Other||Cox Proportional Hazard|1.083||||0.8042|2-Sided|95.0|0.575|2.04|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.|
1685530|NCT01176968|3100402|Superiority or Other||Cox Proportional Hazard|0.726||||0.5338|2-Sided|95.0|0.265|1.99|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.|
1685531|NCT01176968|3100403|Superiority or Other||Cox Proportional Hazard|0.562||||0.6406|2-Sided|95.0|0.05|6.308|||Regression, Cox|||Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.|
1685566|NCT01175824|3100530|Non-Inferiority or Equivalence|Non-inferiority will be concluded if the upper limit of the 95% confidence interval (CI) of the difference in the LS mean between the two treatment arms (twice-daily insulin lispro Low Mixture minus the comparator arm) at 24 weeks is <0.4%.|LS mean difference|-0.21|||||2-Sided|95.0|-0.38|-0.04|||||||
1685665|NCT01174446|3100759|Superiority or Other|||||||0.4208|||||||Paired t-test||||
1685532|NCT01176968|3100404|Superiority or Other||Cox Proportional Hazard|0.581|||<|0.0001|2-Sided|95.0|0.446|0.756||All analyses for primary endpoint were tested at two-sided, α-level of 0.05, without adjusting for multiplicity.|Regression, Cox|||Hazard ratio, 95% confidence interval (CI) of hazard ratio, and p-value for the Primary Analysis based on a Cox proportional hazard model with treatment as the major factor, adjusted for baseline estimated glomerular filtration rate (eGFR), with/without previous MI, time of first dose administered post onset of index symptom, and location of index MI anterior or non-anterior.|
1685533|NCT01176448|3100428|Non-Inferiority or Equivalence (legacy)|With 12 scars (or pairs to compare), our power calculation had a 95 percent probability that the study will detect a treatment difference at a two-sided 0.05 percent significance level, if a significant difference between treatments is 1.5 units (based on a 0-4 scale as mentioned above). This is based on the assumption that the within-patient standard deviation of the response variable is 0.5 units.||||||0.77||||||Appropriately powered, this study failed to reject the null hypothesis that fraxel achieves a similar cosmetic result at 3 months when compared to dermabrasion.|Wilcoxon (Mann-Whitney)|||efficacy outcomes analyzed by 3 surgeons blinded to the treatment and scars evaluated by halves comparing pre-treatment photos to 3-month photos and given a score on the quartile scale described in table 1. The ordinal rater scores of each evaluator were then averaged, and Wilcoxon Signed Ranks performed on the group’s scores. (table 5) There were 4 Fraxel winners, 4 Dermabrasion winners, and 4 ties. There was a p value of 0.77 indicating no significant difference between the categories|
1685534|NCT01176240|3100453|Superiority or Other|||||||0.238|||||||ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.|||
1685535|NCT01176240|3100459|Superiority or Other|||||||0.6||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the first secondary endpoint was not positive, statistical analysis was not performed on additional secondary endpoints.|Wilcoxon (Mann-Whitney)|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.|||
1685536|NCT01176240|3100461|Superiority or Other|||||||0.018||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.|||
1685537|NCT01176240|3100462|Superiority or Other|||||||0.978|||||||ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.||Study 306A was initially designed as a blinded interim analysis by an independent DMC to ensure that the overall study was adequately powered. Study 306A was not powered to provide statistical significance as a stand alone study. Thus, no additional efficacy end points were prospectively defined beyond the primary end point.|
1685538|NCT01175902|3100497|Non-Inferiority or Equivalence|"To prove the non-inferiority of Cosopt to Xalatan, the sample size calculation was based on the assumption that non-inferiority margin of trough IOP of 1.5mmHg. A sample size of n=21 patients per group, this study has 80% power (1-β=0.80) and α=0.05, crossover-designed analysis.~In this study, the upper limit of the 95% CI is expected above the maximal acceptable clinically significant difference of 1.5 mmHg of IOP."|Mean Difference (Final Values)|0.9||||0.05|2-Sided|||||Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|t-test, 2 sided|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|Comparison between two arms were made for IOP, systolic BP, diastolic BP and OPP at each time period.|
1685539|NCT01175850|3100498|Superiority or Other|||||||0.049|||||||Chi-squared||||
1685540|NCT01175850|3100499|Superiority or Other|||||||0.103|||||||Chi-squared||||
1685541|NCT01175850|3100500|Superiority or Other|||||||0.111|||||||Chi-squared||||
1685542|NCT01175850|3100501|Superiority or Other|||||||0.302|||||||Chi-squared||||
1685543|NCT01175850|3100502|Superiority or Other|||||||0.59|||||||Chi-squared||||
1685544|NCT01175850|3100503|Superiority or Other|||||||0.095|||||||Chi-squared||||
1685545|NCT01175850|3100504|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1685546|NCT01175850|3100505|Superiority or Other|||||||0.001|||||||Chi-squared||||
1685547|NCT01175850|3100506|Superiority or Other|||||||0.121|||||||Chi-squared||||
1685548|NCT01175850|3100507|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1685549|NCT01175850|3100508|Superiority or Other|||||||0.096|||||||Chi-squared||||
1685550|NCT01175850|3100509|Superiority or Other||||||>|0.999|||||||Chi-squared||||
1685551|NCT01175850|3100510|Superiority or Other|||||||0.859|||||||Chi-squared||||
1685552|NCT01175850|3100511|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1685553|NCT01175850|3100512|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1685554|NCT01175850|3100513|Superiority or Other|||||||0.926|||||||Chi-squared||||
1685555|NCT01175850|3100514|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1685556|NCT01175850|3100515|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1685557|NCT01175850|3100516|Superiority or Other||||||<|0.001|||||||Z-test|Z-test of two proportions was used to compare treatment groups for all randomized subjects.|||
1685558|NCT01175824|3100517|Superiority or Other||LS mean difference|-0.22|||||2-Sided|95.0|-0.39|-0.05|||||||
1685559|NCT01175824|3100523|Superiority or Other|||||||0.0176||||||p-value is for the comparison at Week 24.|Mixed Models Analysis||||
1685560|NCT01175824|3100523|Superiority or Other|||||||0.2833||||||p-value is for the comparison at Week 12.|Mixed Models Analysis||||
1685561|NCT01175824|3100527|Superiority or Other|||||||0.5353||||||p-value is for the Week 24 comparison|Mixed Models Analysis||||
1685562|NCT01175824|3100527|Superiority or Other|||||||0.0827||||||p-value is for the Week 12 comparison|Mixed Models Analysis||||
1685563|NCT01175824|3100528|Superiority or Other|||||||0.5958||||||HbA1c <=6.5%|Fisher Exact||||
1685564|NCT01175824|3100528|Superiority or Other|||||||0.3588||||||HbA1c concentration <7%|Fisher Exact||||
1685565|NCT01175824|3100529|Superiority or Other|||||||0.1858|||||||Mixed Models Analysis||||
1685657|NCT01175018|3100716|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1685567|NCT01175811|3100538|Superiority or Other|||||||0.392||||||P-value is for the comparison of participants achieving <=7.0% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact||||
1685568|NCT01175811|3100538|Superiority or Other|||||||0.417||||||P-value is for the comparison of participants achieving <=6.5% HbA1c at 24 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact||||
1685569|NCT01175811|3100538|Superiority or Other|||||||0.822||||||P-value is for the comparison of participants achieving <=7.0% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact||||
1685570|NCT01175811|3100538|Superiority or Other|||||||0.344||||||P-value is for the comparison of participants achieving <=6.5% HbA1c at 12 weeks. P-value was not adjusted for multiplicity and should be interpreted as nominal.|Fisher Exact||||
1685571|NCT01175811|3100539|Superiority or Other||LSmean Difference|0.0|||||2-Sided|95.0|-0.15|0.16|||||||
1685572|NCT01175811|3100540|Superiority or Other||LSmean difference|0.01|||||2-Sided|95.0|-0.14|0.16|||||||
1685573|NCT01175473|3100583|Superiority or Other||Least squares (LS) Mean Difference|-154.42|||<|0.0001|2-Sided|95.0|-180.3|-128.54||Linear fixed effects model with fixed terms for treatment, study site and GLU-AUC(0:30-4:30h) at baseline as covariate was used (using Statistical Analysis System [SAS®] PROC MIXED procedure).|Linear fixed effects model|No alpha adjustment was performed.||To detect a difference of 100 or 150 h*mg/dL in change from baseline to Day 28 in GLU-AUC(0:30-4:30h) between lixisenatide and liraglutide, 60 patients per group would provide a power of 90% assuming common standard deviation of 170 or 250 h*mg/dL, respectively, with a 2-sided test at 5% significance level.|
1685574|NCT01175382|3100589|Superiority or Other|||||||0.2384|||||||ANCOVA|||Analysis of Covariance to test whether mean change in International Prostate Symptom Score from Baseline to 12 weeks differed among groups after controlling for baseline International Prostate Symptom Score and age. Last Observation Carried Forward was used to impute missing values.|
1685575|NCT01175382|3100590|Superiority or Other|||||||0.0529|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Overactive Bladder Questionnaire differed among the groups after adjusting for baseline Overactive Bladder Questionnaire Score and age. Last Observation Carried Forward was used to impute missing data|
1685576|NCT01175382|3100591|Superiority or Other|||||||0.507|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Incontinent Episodes differed among the groups after adjusting for baseline Incontinent episodes frequency and age. Last Observation Carried Forward was used to impute missing data|
1685577|NCT01175382|3100592|Superiority or Other|||||||0.0549|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Urgency Score differed among the groups after adjusting for Urgency Scoe and age. Last Observation Carried Forward was used to impute missing data|
1685578|NCT01175382|3100593|Superiority or Other|||||||0.2035|||||||ANCOVA|||Analysis of Covariance testing whether mean change in Nocturia frequency differed among the groups after adjusting for baseline Nocturia frequency and age. Last Observation Carried Forward was used to impute missing data|
1685579|NCT01175382|3100594|Superiority or Other|||||||0.5536|||||||Cochran-Mantel-Haenszel||||
1685580|NCT01175382|3100595|Superiority or Other|||||||0.8153|||||||Cochran-Mantel-Haenszel||||
1685581|NCT01175382|3100596|Superiority or Other|||||||0.3165|||||||Cochran-Mantel-Haenszel||||
1685582|NCT01175382|3100597|Superiority or Other|||||||0.2553|||||||ANCOVA|||Analysis of Covariance to test whether mean change in the International Prostate Symptom Scale (IPSS) from 6 to 12 weeks differed among groups|
1685583|NCT01175382|3100598|Superiority or Other|||||||0.0279|||||||ANCOVA|||Analysis of Covariance to test whether mean change in Overactive Bladder Questionnaire (OAB-q) from 6 to 12 weeks differed among groups after controlling for age and 6 week OAB-q score. Last Observation Carried Forward was used to impute missing values.|
1685584|NCT01175382|3100599|Superiority or Other|||||||0.5578|||||||ANCOVA|||Analysis of Covariance used to test whether mean changes in nocturia from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week nocturia frequency. Last Observation Carried Forward was used to impute missing values.|
1685585|NCT01175382|3100600|Superiority or Other|||||||0.0812|||||||ANCOVA|||Analysis of Covariance to test whether mean change in Incontinence Episodes from 6 weeks to 12 weeks differed among groups after controlling for age and frequency of incontinence episodes at 6 weeks. Last Observation Carried Forward was used to impute missing values.|
1685586|NCT01175382|3100601|Superiority or Other|||||||0.669|||||||ANCOVA|||Analysis of Covariance used to test whether mean changes in Urgency Score from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week Urgency Score. Last Observation Carried Forward was used to impute missing values.|
1685587|NCT01175382|3100602|Superiority or Other|||||||0.0217|||||||Cochran-Mantel-Haenszel||||
1685588|NCT01175382|3100603|Superiority or Other|||||||0.0222|||||||Cochran-Mantel-Haenszel||||
1685589|NCT01175382|3100604|Superiority or Other|||||||0.0022|||||||Cochran-Mantel-Haenszel||||
1685590|NCT01175382|3100605|Superiority or Other||||||<|0.0001|||||||ANCOVA|||"Analysis of Covariance comparing mean chance in IPSS from baseline to 6 weeks among groups controlling for baseline IPSS values and age.~Last Observation Carried Forward was used to impute missing data."|
1685591|NCT01175382|3100606|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Analysis of Covariance comparing mean change in Overactive Bladder Questionnaire from baseline to 6 weeks among groups after controlling for baseline value and age. Last Observation Carried Forward was used to impute missing data.|
1685592|NCT01175382|3100607|Superiority or Other|||||||0.0015|||||||ANCOVA|||Analysis of Covariance comparing mean change in Nocturia among groups adjusting for baseline values of nocturia and age. Last Observation Carried Forward was used to impute missing data.|
1685593|NCT01175382|3100608|Superiority or Other|||||||0.1402|||||||ANCOVA|||Analysis of Covariance comparing mean change score among groups controlling for age and baseline score|
1685594|NCT01175382|3100609|Superiority or Other|||||||0.0051|||||||ANCOVA|||Analysis of Covariance used to test means changes among the groups adjusting for baseline values and age. Last Observation Carried Forward was used to impute missing data.|
1685595|NCT01175382|3100610|Superiority or Other|||||||0.2933|||||||ANCOVA|||Analysis of Covariance testing whether mean change in 24-hour voiding frequency differed among the groups after adjusting for baseline voiding frequency and age. Last Observation Carried Forward was used to impute missing data.|
1685596|NCT01175382|3100611|Superiority or Other|||||||0.0013|||||||ANCOVA|||Analysis of Covariance to test for differences in mean change from 6 weeks to 12 weeks in voiding frequency controlling for age and 6 week frequency. Last Observation Carried Forward was used to impute missing data.|
1685597|NCT01175382|3100612|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis of Covariance used to compare mean changes from baseline to 6 weeks among groups adjusting for baseline values and age. Last Observation Carried Forward was used for imputation of missing data.|
1685598|NCT01175226|3100629|Superiority|||||||0.02|||||||ANCOVA||||
1685599|NCT01175213|3100653|Superiority or Other||Poisson|0.02|||<|0.0001|1-Sided|99.0||0.045||Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.|Poisson||||
1685600|NCT01175148|3100654|Superiority or Other||Odds Ratio (OR)|0.15|||<|0.05|2-Sided||||||Fisher Exact|||The study used a minimax Simon two-stage design to test the null hypothesis Ho: P > 0.35 versus the alternative H1: < 0.15, where P is the probability of grade 2 to 4 acute GVHD at day + 100.|
1685601|NCT01175135|3100666|Other||LS Mean Difference|2.53|Standard Error of the Mean|1.907||0.093|2-Sided|80.0|0.08|4.99||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685602|NCT01175135|3100666|Other||LS Mean Difference|0.24|Standard Error of the Mean|1.492||0.4354|2-Sided|80.0|-1.68|2.16||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685603|NCT01175135|3100666|Other||LS Mean Difference|-0.16|Standard Error of the Mean|1.478||0.5429|2-Sided|80.0|-2.06|1.74||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline GAF score, investigator site, treatment, visit, treatment by visit interaction, baseline GAF score by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685604|NCT01175135|3100667|Other||LS Mean Difference|-0.75|Standard Error of the Mean|0.255||0.0019|2-Sided|80.0|-1.07|-0.42||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685605|NCT01175135|3100667|Other||LS Mean Difference|0.12|Standard Error of the Mean|0.198||0.7275|2-Sided|80.0|-0.13|0.37||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685606|NCT01175135|3100667|Other||LS Mean Difference|-0.07|Standard Error of the Mean|0.196||0.3598|2-Sided|80.0|-0.32|0.18||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for investigator site, treatment, visit, treatment by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685607|NCT01175135|3100668|Other||LS Mean Difference|-2.0|Standard Error of the Mean|0.723||0.0031|2-Sided|80.0|-2.93|-1.07||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685608|NCT01175135|3100668|Other||LS Mean Difference|-0.04|Standard Error of the Mean|0.562||0.4747|2-Sided|80.0|-0.76|0.69||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685609|NCT01175135|3100668|Other||LS Mean Difference|-0.34|Standard Error of the Mean|0.559||0.2727|2-Sided|80.0|-1.06|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS derived BPRS core score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS derived BPRS core score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685610|NCT01175135|3100669|Other||LS Mean Difference|-1.68|Standard Error of the Mean|0.677||0.0069|2-Sided|80.0|-2.55|-0.81||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685611|NCT01175135|3100669|Other||LS Mean Difference|0.47|Standard Error of the Mean|0.526||0.8155|2-Sided|80.0|-0.2|1.15||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685612|NCT01175135|3100669|Other||LS Mean Difference|0.12|Standard Error of the Mean|0.523||0.5894|2-Sided|80.0|-0.55|0.79||Reported p-value was 1-sided.|Mixed Models Analysis|||Anxiety/Depression Score: MMRM model with fixed effect for baseline PANSS Marder anxiety/depression score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder anxiety/depression score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685613|NCT01175135|3100669|Other||LS Mean Difference|-1.66|Standard Error of the Mean|0.641||0.0052|2-Sided|80.0|-2.48|-0.84||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685658|NCT01175018|3100717|Superiority or Other||||||>|0.05|||||||ANOVA||||
1685659|NCT01175018|3100718|Superiority or Other||||||<|0.05|||||||ANOVA||||
1685614|NCT01175135|3100669|Other||LS Mean Difference|0.15|Standard Error of the Mean|0.499||0.6214|2-Sided|80.0|-0.49|0.8||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685615|NCT01175135|3100669|Other||LS Mean Difference|-0.04|Standard Error of the Mean|0.495||0.4685|2-Sided|80.0|-0.68|0.6||Reported p-value was 1-sided.|Mixed Models Analysis|||Uncontrolled hostility/excitement Score: MMRM model with fixed effect for baseline PANSS Marder hostility/excitement score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder hostility/excitement score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685616|NCT01175135|3100669|Other||LS Mean Difference|-1.48|Standard Error of the Mean|0.813||0.0346|2-Sided|80.0|-2.53|-0.44||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685617|NCT01175135|3100669|Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.632||0.4345|2-Sided|80.0|-0.92|0.71||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685618|NCT01175135|3100669|Other||LS Mean Difference|-0.43|Standard Error of the Mean|0.627||0.248|2-Sided|80.0|-1.23|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||Disorganized Thought Score: MMRM model with fixed effect for baseline PANSS Marder disorganized thought score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder disorganized thought score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685619|NCT01175135|3100669|Other||LS Mean Difference|-0.79|Standard Error of the Mean|1.002||0.2161|2-Sided|80.0|-2.08|0.5||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685620|NCT01175135|3100669|Other||LS Mean Difference|-0.57|Standard Error of the Mean|0.783||0.2354|2-Sided|80.0|-1.57|0.44||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685621|NCT01175135|3100669|Other||LS Mean Difference|-0.77|Standard Error of the Mean|0.778||0.1625|2-Sided|80.0|-1.77|0.23||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS Marder negative score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder negative score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685622|NCT01175135|3100669|Other||LS Mean Difference|-2.62|Standard Error of the Mean|1.117||0.01|2-Sided|80.0|-4.06|-1.18||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685623|NCT01175135|3100669|Other||LS Mean Difference|-0.36|Standard Error of the Mean|0.87||0.3399|2-Sided|80.0|-1.48|0.76||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685624|NCT01175135|3100669|Other||LS Mean Difference|-0.73|Standard Error of the Mean|0.863||0.1999|2-Sided|80.0|-1.84|0.38||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS Marder positive score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS Marder positive score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685625|NCT01175135|3100670|Other||LS Mean Difference|-0.35|Standard Error of the Mean|0.199||0.0395|2-Sided|80.0|-0.61|-0.1||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685626|NCT01175135|3100670|Other||LS Mean Difference|-0.05|Standard Error of the Mean|0.154||0.3835|2-Sided|80.0|-0.24|0.15||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685627|NCT01175135|3100670|Other||LS Mean Difference|-0.13|Standard Error of the Mean|0.154||0.197|2-Sided|80.0|-0.33|0.07||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline CGI-S, investigator site, treatment, visit, treatment by visit interaction, a baseline CGI-S by visit interaction and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685628|NCT01175135|3100671|Other||LS Mean Difference|-3.66|Standard Error of the Mean|1.718||0.0172|2-Sided|80.0|-5.86|-1.45||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.|
1685660|NCT01175005|3100719|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1685629|NCT01175135|3100671|Other||LS Mean Difference|-0.1|Standard Error of the Mean|1.339||0.471|2-Sided|80.0|-1.82|1.62||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.|
1685630|NCT01175135|3100671|Other||LS Mean Difference|-0.74|Standard Error of the Mean|1.33||0.2904|2-Sided|80.0|-2.45|0.97||Reported p-value was 1-sided.|Mixed Models Analysis|||General Score: MMRM model with fixed effect for baseline PANSS general subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS general subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.|
1685631|NCT01175135|3100671|Other||LS Mean Difference|-1.26|Standard Error of the Mean|0.944||0.0907|2-Sided|80.0|-2.48|-0.05||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.|
1685632|NCT01175135|3100671|Other||LS Mean Difference|-0.61|Standard Error of the Mean|0.735||0.203|2-Sided|80.0|-1.56|0.33||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.|
1685633|NCT01175135|3100671|Other||LS Mean Difference|-0.96|Standard Error of the Mean|0.73||0.0942|2-Sided|80.0|-1.9|-0.02||Reported p-value was 1-sided.|Mixed Models Analysis|||Negative Score: MMRM model with fixed effect for baseline PANSS negative subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS negative subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.|
1685634|NCT01175135|3100671|Other||LS Mean Difference|-2.99|Standard Error of the Mean|1.093||0.0034|2-Sided|80.0|-4.4|-1.59||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.|
1685635|NCT01175135|3100671|Other||LS Mean Difference|0.15|Standard Error of the Mean|0.854||0.57|2-Sided|80.0|-0.95|1.25||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.|
1685636|NCT01175135|3100671|Other||LS Mean Difference|-0.41|Standard Error of the Mean|0.845||0.3144|2-Sided|80.0|-1.5|0.68||Reported p-value was 1-sided.|Mixed Models Analysis|||Positive Score: MMRM model with fixed effect for baseline PANSS positive subscale score, investigator site, treatment, visit, a treatment by visit interaction and a baseline PANSS positive subscale score by visit interaction and a random effect for participant. The model was fit using an unstructured covariance matrix.|
1685637|NCT01175135|3100672|Other||Difference in Proportion|-0.04|||||2-Sided|80.0|-0.08|0.0|||||The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.||
1685638|NCT01175135|3100672|Other||Difference in Proportion|0.04|||||2-Sided|80.0|-0.02|0.1|||||The adjusted 80% CI equals 88.6% CI, adjusted due to 1 interim look.||
1685639|NCT01175135|3100672|Other||Difference in Proportion|-0.03|||||2-Sided|80.0|-0.07|0.01|||||The adjusted 80% Confidence Interval (CI) equals 88.6% CI, adjusted due to 1 interim look.||
1685640|NCT01175135|3100673|Other||LS Mean Difference|-8.24|Standard Error of the Mean|3.453||0.009|2-Sided|80.0|-12.68|-3.8||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685641|NCT01175135|3100673|Other||LS Mean Difference|-0.67|Standard Error of the Mean|2.698||0.4024|2-Sided|80.0|-4.14|2.8||Reported p-value was 1-sided.|Mixed Models Analysis|||MMRM model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685642|NCT01175135|3100673|Other||Least Squares (LS) Mean Difference|-2.21|Standard Error of the Mean|2.683||0.2053|2-Sided|80.0|-5.66|1.24||Reported p-value was 1-sided.|Mixed Models Analysis|||Mixed effect repeated measures (MMRM) model with fixed effect for baseline PANSS total score, investigator site, treatment, visit, treatment by visit interaction and baseline PANSS total score by visit interaction, and random effect for participant. The model was fit using an unstructured covariance matrix.|
1685643|NCT01175031|3100702|Superiority or Other|||||||0.003|||||||signed-rank tests||||
1685644|NCT01175018|3100703|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1685645|NCT01175018|3100704|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1685646|NCT01175018|3100705|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1685647|NCT01175018|3100706|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1685648|NCT01175018|3100707|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1685649|NCT01175018|3100708|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1685650|NCT01175018|3100709|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1685651|NCT01175018|3100710|Superiority or Other||||||>|0.05|||||||ANOVA||||
1685652|NCT01175018|3100711|Superiority or Other||||||>|0.05|||||||ANOVA||||
1685653|NCT01175018|3100712|Superiority or Other||||||>|0.05|||||||ANOVA||||
1685654|NCT01175018|3100713|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1685655|NCT01175018|3100714|Superiority or Other||||||<|0.05|||||||Log Rank||||
1685656|NCT01175018|3100715|Superiority or Other||||||>|0.05|||||||ANOVA||||
1685668|NCT01174446|3100761|Superiority or Other|||||||0.0562|||||||Paired t-test||||
1685669|NCT01174446|3100762|Superiority or Other|||||||0.489|||||||Paired t-test||||
1685670|NCT01174446|3100762|Superiority or Other|||||||0.0663|||||||Paired t-test||||
1685671|NCT01174446|3100763|Superiority or Other|||||||0.641|||||||Paired t-test||||
1685672|NCT01174446|3100763|Superiority or Other|||||||0.1048|||||||Paired t-test||||
1685673|NCT01174446|3100764|Superiority or Other|||||||0.2567|||||||Paired t-test||||
1685674|NCT01174446|3100764|Superiority or Other|||||||0.1258|||||||Paired t-test||||
1685675|NCT01174446|3100765|Superiority or Other|||||||0.4048|||||||Paired t-test||||
1685676|NCT01174446|3100765|Superiority or Other|||||||0.0146|||||||Paired t-test||||
1685677|NCT01174446|3100766|Superiority or Other|||||||0.5565|||||||Paired t-test||||
1685678|NCT01174446|3100766|Superiority or Other|||||||0.821|||||||Paired t-test||||
1685679|NCT01174446|3100767|Superiority or Other|||||||0.3176|||||||Paired t-test||||
1685680|NCT01174446|3100767|Superiority or Other|||||||0.0162|||||||Paired t-test||||
1685681|NCT01174446|3100768|Superiority or Other|||||||0.9223|||||||Paired t-test||||
1685682|NCT01174446|3100768|Superiority or Other|||||||0.5143|||||||Paired t-test||||
1685683|NCT01174446|3100769|Superiority or Other|||||||0.3552|||||||Paired t-test||||
1685684|NCT01174446|3100769|Superiority or Other|||||||0.2009|||||||Paired t-test||||
1685685|NCT01174446|3100770|Superiority or Other|||||||0.2974|||||||Paired t-test||||
1685686|NCT01174446|3100770|Superiority or Other|||||||0.0189|||||||Paired t-test||||
1685687|NCT01174446|3100771|Superiority or Other|||||||0.4098|||||||Paired t-test||||
1685688|NCT01174446|3100771|Superiority or Other|||||||0.9059|||||||Paired t-test||||
1685689|NCT01174446|3100772|Superiority or Other|||||||0.413|||||||Paired t-test||||
1685690|NCT01174446|3100772|Superiority or Other|||||||0.0056|||||||Paired t-test||||
1685691|NCT01174446|3100773|Superiority or Other|||||||0.8999|||||||Paired t-test||||
1685692|NCT01174446|3100773|Superiority or Other|||||||0.779|||||||Paired t-test||||
1685693|NCT01174446|3100800|Non-Inferiority or Equivalence|Bioequivalence will be established if 90% C.I. of ratio is contained completely in the margins of equivalence of 0.8 to 1.25.|Ratio of Geometric Means|1.063|||||2-Sided|90.0|1.03|1.09|||||||
1685694|NCT01174264|3100805|Superiority or Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1685695|NCT01174264|3100806|Superiority or Other||Ratio of geometric means|1.22||||0.096|2-Sided|90.0|1.0|1.48||Performed on log-transformed data.|t-test, 2 sided||||
1685696|NCT01174264|3100807|Superiority or Other||Ratio of geometric means|1.13||||0.25|2-Sided|90.0|0.95|1.35|||t-test, 2 sided|Performed on log-transformed data.|||
1685697|NCT01174264|3100808|Superiority or Other||Ratio of geometric means|1.16||||0.17|2-Sided|90.0|0.97|1.38|||t-test, 2 sided|Performed on log-transformed data.|||
1685698|NCT01174264|3100809|Superiority or Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)||||
1685699|NCT01174264|3100809|Superiority or Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)||||
1685700|NCT01174264|3100810|Superiority or Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)||||
1685701|NCT01174264|3100810|Superiority or Other|||||||0.83|||||||Wilcoxon (Mann-Whitney)||||
1685702|NCT01174264|3100812|Superiority or Other||Ratio of geometric means|1.12||||0.51|2-Sided|90.0|0.84|1.49|||t-test, 2 sided|Performed on log-transformed data.|||
1685703|NCT01174264|3100812|Superiority or Other||Ratio of geometric means|1.74||||0.008|2-Sided|90.0|1.25|2.42|||t-test, 2 sided|Performed on log-transformed data.|||
1685704|NCT01174264|3100813|Superiority or Other||Ratio of geometric means|1.08||||0.65|2-Sided|90.0|0.81|1.44||Performed on log-transformed data.|t-test, 2 sided||||
1685705|NCT01174264|3100813|Superiority or Other||Ratio of geometric means|1.75||||0.003|2-Sided|90.0|1.3|2.34|||t-test, 2 sided|Performed on log-transformed data.|||
1685706|NCT01174173|3100823|Superiority or Other|||||||0.66|||||||t-test, 2 sided||||
1685707|NCT01174173|3100824|Superiority or Other|||||||0.037|||||||t-test, 2 sided||||
1685708|NCT01174173|3100826|Superiority or Other|||||||0.37||||||A two-sided t-test was performed for difference from baseline and 3-month KCCQ score. A p-value of <0.05 was considered statistically significant a priori.|t-test, 2 sided||||
1685709|NCT01174173|3100827|Superiority or Other|||||||0.09||||||A two-sided t-test was performed for change in 6-minute walk test and p-value < 0.05 was considered statistically significant a priori.|t-test, 2 sided||||
1685710|NCT01174173|3100828|Superiority or Other|||||||0.0013||||||A two-sided t-test was performed with p-value < 0.05 was considered statistically significant a priori.|t-test, 2 sided||||
1685711|NCT01174030|3100835|Superiority or Other||Odds Ratio (OR)|2.365||||0.054||95.0|0.96|5.825|||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.|||
1685712|NCT01174030|3100835|Superiority or Other||Odds Ratio (OR)|1.853||||0.093||95.0|0.903|3.802|||GEE: Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.|||
1685713|NCT01174030|3100835|Superiority or Other||Odds Ratio (OR)|6.582|||<|0.001||95.0|2.755|15.723|||GEE: Logit link function|Generalize Estimating Equation (GEE) methods with Logit link function and marginal expectation model.|||
1685714|NCT01174030|3100836|Superiority or Other||Odds Ratio (OR)|1.885||||0.074||95.0|0.946|3.756|||GEE:Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.|||
1685715|NCT01174030|3100836|Superiority or Other||Odds Ratio (OR)|1.892||||0.056||95.0|0.98|3.651|||GEE: Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.|||
1685716|NCT01174030|3100836|Superiority or Other||Odds Ratio (OR)|2.683||||0.003||95.0|1.388|5.188|||GEE:Logit link Function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model|||
1685717|NCT01174030|3100837|Superiority or Other||Odds Ratio (OR)|3.738||||0.027||95.0|1.097|12.742|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.|||
1685718|NCT01174030|3100837|Superiority or Other||Odds Ratio (OR)|1.269||||0.549||95.0|0.586|2.747|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.|||
1685719|NCT01174030|3100837|Superiority or Other||Odds Ratio (OR)|8.392|||<|0.001||95.0|2.637|26.71|||GEE:Logit link function|Generalized Estimating Equation (GEE) methods with Logit link function and marginal expectation model.|||
1685720|NCT01173653|3100854|Superiority or Other||Chi square|23.02|||<|0.05|||||||Chi-squared||||
1685721|NCT01173601|3100875|Superiority or Other|||||||0.201||||||In order to test the primary outcome between each LY2216684 dose and placebo while controlling the overall Type I error at 0.05, the significance level was a priori partitioned equally between the 2 LY2216684 dose-placebo comparisons at 0.025.|Mixed Models Analysis||||
1685722|NCT01173601|3100875|Superiority or Other|||||||0.338||||||In order to test the primary outcome between each LY2216684 dose and placebo while controlling the overall Type I error at 0.05, the significance level was a priori partitioned equally between the 2 LY2216684 dose-placebo comparisons at 0.025.|Mixed Models Analysis||||
1685723|NCT01173471|3100880|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.909||0.467|2-Sided|95.0|-2.5|1.2|||Mixed Models Analysis||Difference is (AZD4017 400 mg BID - Placebo BID)||
1685724|NCT01173471|3100880|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|1.57||0.758|2-Sided|95.0|-4.8|3.7|||Mixed Models Analysis||Difference is (AZD4017 200 mg OD - Placebo OD)||
1685725|NCT01173471|3100882|Superiority or Other||Mean Difference (Final Values)|-2.9|Standard Error of the Mean|3.516||0.413|2-Sided|95.0|-10.1|4.3|||Mixed Models Analysis||Difference is (AZD4017 400 mg BID - Placebo BID)||
1685726|NCT01173471|3100882|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|5.352||0.822|2-Sided|95.0|-15.2|12.6|||Mixed Models Analysis||Difference is (AZD4017 200 mg OD - Placebo OD)||
1685727|NCT01173029|3100931|Superiority or Other||Hazard Ratio (HR)|2.9||||0.04|2-Sided|95.0|1.2|9.2||The p-value was adjusted for confounders: Framingham risk score, body mass index, ethnic group|Regression, Cox|The actuarial function of events per time since the first diagnosis of arterial hypertension was plotted for polygenic risk score<=3 and >3.||Cox proportional hazard model of the polygenic risk score<=3 and > 3 for the composite endpoint (stroke + myocardial infarction). By taking polygenic risk score<=3, the hazard ratio for the composite endpoint was calculated for polygenic risk score>3 .|
1685728|NCT01173029|3100931|Superiority or Other||C-statistic|0.66|||<|0.01|2-Sided|95.0|0.56|0.76||At an optimal value of >3, polygenic risk score yielded 90% sensitivity and 40% specificity for composite endpoint.|z test|Area under receiver operating characteristic curve.|The optimal cutoff value for polygenic risk score was set to >3.|Receiver operating characteristic curve analysis for the polygenic score as predictor of composite endpoint (stroke + myocardial infarction)|
1685729|NCT01173029|3100932|Non-Inferiority or Equivalence|Proportional-risk hypothesis was tested using the correlation between Schoenfeld's residuals and time (Schoenfeld's global test). The correlation rho was -0.08, Chi-squared was 0.12, and p was 0.73. Therefore, the hypothesis of proportional risk was accepted, validating the correct application model.|Hazard Ratio (HR)|2.2||||0.04|2-Sided|95.0|1.1|4.8||The p-value was adjusted for confounders: Framingham risk score, body mass index, ethnic groups|Regression, Cox|The actuarial function of events per time since the first diagnosis of arterial hypertension was plotted for both groups.||Cox proportional hazard model for the composite endpoint (stroke + myocardial infarction) was assessed. By taking pseudo-resistant arterial hypertension as baseline reference, the hazard ratio for the composite endpoint was calculated.|
1685730|NCT01173029|3100932|Non-Inferiority or Equivalence|Study power calculation was post-hoc based on composite end-point achieved. Number of exposed: 62 Non-exposed to exposed ratio: 0.5 Relative risk worth detecting: 2.5 Attack rate among non-exposed: 23% Alpha risk: 0.05 Calculated power: 89.8%|Risk Ratio (RR)|2.6||||0.01|2-Sided|95.0|1.01|7.3||not adjusted|Chi-squared, Corrected|1 degree-of-freedom||"Long-term intention-to-treat data analysis:~Student 't' test Yates' corrected Chi-squared or Fisher's exact test Relative risk estimation Cox proportional-hazard model Hardy-Weinberg equilibrium"|
1685731|NCT01173029|3100933|Non-Inferiority or Equivalence|Study power calculation was post-hoc based on composite end-point achieved. Number of exposed: 62 Non-exposed to exposed ratio: 0.5 Relative risk worth detecting: 2.5 Attack rate among non-exposed: 23% Alpha risk: 0.05 Calculated power: 89.8%|Risk Ratio (RR)|1.7||||0.19|2-Sided|95.0|0.7|4.1||not adjusted|Chi-squared, Corrected|1 degree-of-freedom||"Long-term intention-to-treat data analysis:~Student 't' tests Yates's corrected Chi-squared or Fisher's exact test, when appropriate Relative risk estimation Cox proportional-hazard model Hardy-Weinberg equilibrium"|
1685732|NCT01173016|3100934|Other|||||||0.038|||||||Regression, Logistic|||Impact of anti-laronidase antibody status on the change in 6MWT outcome was tested|
1685733|NCT01172938|3100962|Superiority or Other (legacy)||Adjusted Difference|8.8|||||2-Sided|95.0|-8.5|26.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685734|NCT01172938|3100962|Superiority or Other (legacy)||Adjusted Difference|5.8|||||2-Sided|95.0|-10.7|22.4|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685735|NCT01172938|3100963|Superiority or Other (legacy)||Adjusted Difference|16.8|||||2-Sided|95.0|5.6|27.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685736|NCT01172938|3100963|Superiority or Other (legacy)||Adjusted Difference|17.4|||||2-Sided|95.0|6.6|28.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685737|NCT01172938|3100964|Superiority or Other (legacy)||Adjusted Difference|2.4|||||2-Sided|95.0|-14.8|19.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685738|NCT01172938|3100964|Superiority or Other (legacy)||Adjusted Difference|-1.4|||||2-Sided|95.0|-17.7|14.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685739|NCT01172938|3100965|Superiority or Other (legacy)||Adjusted Difference|11.9|||||2-Sided|95.0|0.8|23.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685740|NCT01172938|3100965|Superiority or Other (legacy)||Adjusted Difference|7.6|||||2-Sided|95.0|-2.8|17.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685741|NCT01172938|3100966|Superiority or Other (legacy)||Adjusted Difference|4.7|||||2-Sided|95.0|1.2|8.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685742|NCT01172938|3100966|Superiority or Other (legacy)||Adjusted Difference|9.5|||||2-Sided|95.0|4.8|14.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685743|NCT01172938|3100967|Superiority or Other (legacy)||Adjusted Difference|10.1|||||2-Sided|95.0|4.0|16.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685744|NCT01172938|3100967|Superiority or Other (legacy)||Adjusted Difference|14.9|||||2-Sided|95.0|8.3|21.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685745|NCT01172938|3100968|Superiority or Other (legacy)||Adjusted Difference|4.8|||||2-Sided|95.0|0.8|8.7|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685746|NCT01172938|3100968|Superiority or Other (legacy)||Adjusted Difference|3.1|||||2-Sided|95.0|-0.4|6.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685747|NCT01172938|3100969|Superiority or Other (legacy)||Adjusted Difference|9.5|||||2-Sided|95.0|3.0|16.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685748|NCT01172938|3100969|Superiority or Other (legacy)||Adjusted Difference|10.3|||||2-Sided|95.0|3.7|16.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685749|NCT01172938|3100970|Superiority or Other (legacy)||Adjusted Difference|14.2|||||2-Sided|95.0|5.4|23.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685750|NCT01172938|3100970|Superiority or Other (legacy)||Adjusted Difference|26.3|||||2-Sided|95.0|17.1|35.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685751|NCT01172938|3100971|Superiority or Other (legacy)||Adjusted Difference|7.7|||||2-Sided|95.0|-8.7|24.2|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685752|NCT01172938|3100971|Superiority or Other (legacy)||Adjusted Difference|8.9|||||2-Sided|95.0|-6.8|24.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685753|NCT01172938|3100972|Superiority or Other (legacy)||Adjusted Difference|11.3|||||2-Sided|95.0|-2.4|25.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685754|NCT01172938|3100972|Superiority or Other (legacy)||Adjusted Difference|13.2|||||2-Sided|95.0|-0.1|26.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685755|NCT01172938|3100973|Superiority or Other (legacy)||Adjusted Difference|16.6|||||2-Sided|95.0|6.4|26.8|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685756|NCT01172938|3100973|Superiority or Other (legacy)||Adjusted Difference|19.2|||||2-Sided|95.0|9.0|29.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685757|NCT01172938|3100974|Superiority or Other (legacy)||Adjusted Difference|7.7|||||2-Sided|95.0|-9.1|24.6|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685972|NCT01169103|3101445|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1685973|NCT01169103|3101446|Superiority or Other|||||||0.58|||||||t-test, 2 sided||||
1685758|NCT01172938|3100974|Superiority or Other (legacy)||Adjusted Difference|2.9|||||2-Sided|95.0|-13.4|19.3|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685759|NCT01172938|3100975|Superiority or Other (legacy)||Adjusted Difference|7.3|||||2-Sided|95.0|-6.5|21.1|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685760|NCT01172938|3100975|Superiority or Other (legacy)||Adjusted Difference|3.3|||||2-Sided|95.0|-10.1|16.7|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685761|NCT01172938|3100976|Superiority or Other (legacy)||LS Mean DIfference|0.4|||||2-Sided|95.0|-1.5|2.29|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685762|NCT01172938|3100976|Superiority or Other (legacy)||LS mean Difference|2.21|||||2-Sided|95.0|0.32|4.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685763|NCT01172938|3100977|Superiority or Other (legacy)||LS Mean Difference|-0.46|||||2-Sided|95.0|-0.7|-0.22|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685764|NCT01172938|3100977|Superiority or Other (legacy)||LS Mean Difference|-0.7|||||2-Sided|95.0|-0.94|-0.46|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685765|NCT01172938|3100978|Superiority or Other (legacy)||LS mean Difference|-4.41|||||2-Sided|95.0|-7.03|-1.79|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685766|NCT01172938|3100978|Superiority or Other (legacy)||LS mean Difference|-6.38|||||2-Sided|95.0|-9.0|-3.75|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685767|NCT01172938|3100979|Superiority or Other (legacy)||LS Mean Difference|-0.7|||||2-Sided|95.0|-1.5|0.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685768|NCT01172938|3100979|Superiority or Other (legacy)||LS Mean Difference|-0.5|||||2-Sided|95.0|-1.2|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685769|NCT01172938|3100980|Superiority or Other (legacy)||LS Mean DIfference|-0.8|||||2-Sided|95.0|-1.6|0.1|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685770|NCT01172938|3100980|Superiority or Other (legacy)||LS Mean Difference|-0.8|||||2-Sided|95.0|-1.6|0.0|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685771|NCT01172938|3100981|Superiority or Other (legacy)||LS Mean Difference|-7.1|||||2-Sided|95.0|-12.0|-2.2|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685772|NCT01172938|3100981|Superiority or Other (legacy)||Adjusted Difference|-10.6|||||2-Sided|95.0|-15.4|-5.7|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685773|NCT01172938|3100982|Superiority or Other (legacy)||Adjusted Difference|12.4|||||2-Sided|95.0|3.4|21.5|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685774|NCT01172938|3100982|Superiority or Other (legacy)||Adjusted Difference|24.6|||||2-Sided|95.0|15.2|34.0|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685775|NCT01172938|3100983|Superiority or Other (legacy)||LS Mean Difference|2.04|||||2-Sided|95.0|0.21|3.88|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685776|NCT01172938|3100983|Superiority or Other (legacy)||LS Mean Difference|3.56|||||2-Sided|95.0|1.72|5.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685777|NCT01172938|3100984|Superiority or Other (legacy)||LS Mean Difference|0.13|||||2-Sided|95.0|-1.77|2.03|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685778|NCT01172938|3100984|Superiority or Other (legacy)||LS Mean Difference|2.33|||||2-Sided|95.0|0.43|4.23|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685779|NCT01172938|3100985|Superiority or Other (legacy)||LS Mean Difference|-0.47|||||2-Sided|95.0|-0.7|-0.25|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685780|NCT01172938|3100985|Superiority or Other (legacy)||LS Mean Difference|-0.53|||||2-Sided|95.0|-0.76|-0.31|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685781|NCT01172938|3100986|Superiority or Other (legacy)||LS Mean Difference|-4.39|||||2-Sided|95.0|-6.92|-1.86|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685782|NCT01172938|3100986|Superiority or Other (legacy)||LS Mean Difference|-4.88|||||2-Sided|95.0|-7.41|-2.34|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685974|NCT01169103|3101447|Superiority or Other|||||||0.0396|||||||t-test, 2 sided|||Change in High-density lipoprotein p-value|
1685783|NCT01172938|3100987|Superiority or Other (legacy)||LS Mean Difference|-0.5|||||2-Sided|95.0|-1.3|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685784|NCT01172938|3100987|Superiority or Other (legacy)||LS Mean Difference|-0.3|||||2-Sided|95.0|-1.1|0.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685785|NCT01172938|3100988|Superiority or Other (legacy)||LS Mean Difference|-0.5|||||2-Sided|95.0|-1.3|0.3|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685786|NCT01172938|3100988|Superiority or Other (legacy)||LS Mean Difference|-0.4|||||2-Sided|95.0|-1.2|0.4|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685787|NCT01172938|3100989|Superiority or Other (legacy)||LS Mean Difference|-5.8|||||2-Sided|95.0|-10.8|-0.7|||||Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||
1685788|NCT01172938|3100989|Superiority or Other (legacy)||LS Mean Difference|-7.9||||0.0023|2-Sided|95.0|-12.9|-2.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1685789|NCT01172938|3100990|Superiority or Other (legacy)||Adjusted Difference|8.9|||||2-Sided|95.0|-1.2|18.9|||||Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685790|NCT01172938|3100990|Superiority or Other (legacy)||Adjusted Difference|16.7||||0.0017|2-Sided|95.0|6.6|26.8||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685791|NCT01172938|3100991|Superiority or Other (legacy)||LS Mean Difference|1.7||||0.0504|2-Sided|95.0|0.0|3.4||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1685792|NCT01172938|3100991|Superiority or Other (legacy)||LS Mean Difference|2.42||||0.0056|2-Sided|95.0|0.71|4.13||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1685793|NCT01172938|3100992|Superiority or Other (legacy)||LS Mean Difference|-0.135||||0.0091|2-Sided|95.0|-0.236|-0.034||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1685794|NCT01172938|3100992|Superiority or Other (legacy)||LS Mean Difference|-0.182||||0.0005|2-Sided|95.0|-0.283|-0.08||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.|||
1685795|NCT01172938|3100993|Superiority or Other (legacy)||Adjusted Difference|12.4||||0.0038|2-Sided|95.0|4.2|20.7||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685796|NCT01172938|3100993|Superiority or Other (legacy)||Adjusted Difference|22.2|||<|0.0001|2-Sided|95.0|13.4|30.9||Secondary endpoints from the placebo-controlled period (Weeks 16 and 24) were analyzed in a hierarchical fashion to control the Type I error rate as described above.|Cochran-Mantel-Haenszel|The 2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the Cochran-Mantel-Haenszel (CMH) weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.||
1685797|NCT01172938|3100994|Superiority or Other (legacy)||LS Mean Difference|-0.113||||0.0252|2-Sided|95.0|-0.211|-0.014|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.|
1685798|NCT01172938|3100994|Superiority or Other (legacy)||LS Mean Difference|-0.159||||0.0017|2-Sided|95.0|-0.258|-0.06|||ANCOVA|Based on an ANCOVA model with treatment group and baseline DMARD use as factors, and the baseline value as a covariate.||Pairwise comparisons (30 mg vs placebo and 20 mg vs placebo) were conducted conditional on the primary endpoint results. If the primary endpoint was statistically significant for both apremilast dose groups, pairwise comparisons for the HAQ-DI were to be evaluated at the 0.05 level using the Hochberg procedure. If only one apremilast dose was statistically significant, then only the comparison between that apremilast dose and placebo was conducted for the HAQ-DI score, at the 0.025 level.|
1685975|NCT01169103|3101447|Superiority or Other|||||||0.062|||||||t-test, 2 sided|||Change in Low-density lipoprotein p-value|
1685799|NCT01172938|3100995|Superiority or Other (legacy)||Adjusted Difference|11.3||||0.0166|2-Sided|95.0|2.2|20.4|||Cochran-Mantel-Haenszel|2-sided p-value is based on the CMH test adjusting for baseline DMARD use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% CI is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.|
1685800|NCT01172938|3100995|Superiority or Other (legacy)||Adjusted Difference|19.0||||0.0001|2-Sided|95.0|9.7|28.3|||Cochran-Mantel-Haenszel|2-sided p-value is based on the Cochran-Mantel-Haenszel (CMH) test adjusting for baseline disease modifying antirheumatic drug (DMARD) use.|Adjusted difference is the weighted average of the treatment differences across the 2 strata of baseline DMARD use with the CMH weights. The 2-sided 95% confidence interval (CI) is based on a normal approximation to the weighted average.|In order to maintain the Type 1 error at the 0.05 significance level, the Hochberg procedure was to be used. The results of the endpoint were to be considered statistically significant if both the 30 mg apremilast dose versus placebo comparison and the 20 mg versus placebo comparison were statistically significant at the 0.05 significance level, or one of the comparisons was statistically significant at the 0.025 level.|
1685801|NCT01172847|3101003|Superiority or Other||mean exposure ratio|1.03|||||2-Sided|90.0|0.99|1.06|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|mean exposure ratio of rimantadine|
1685802|NCT01172847|3101004|Superiority or Other||mean exposure ratio|0.98|||||2-Sided|90.0|0.92|1.05|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir carboxylate|
1685803|NCT01172847|3101004|Superiority or Other||mean exposure ratio|0.86|||||2-Sided|90.0|0.77|0.96|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir|
1685804|NCT01172847|3101005|Superiority or Other||mean exposure ratio|1.03|||||2-Sided|90.0|1.0|1.06|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of rimantadine|
1685805|NCT01172847|3101006|Superiority or Other||mean exposure ratio|0.98|||||2-Sided|90.0|0.95|1.02|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir carboxylate|
1685806|NCT01172847|3101006|Superiority or Other||mean exposure ratio|0.98|||||2-Sided|90.0|0.91|1.05|||||Estimate of the treatment difference and corresponding 90% CI was derived from the back-transformed model.|Mean exposure ratio of oseltamivir|
1685807|NCT01172821|3101009|Superiority or Other||Odds Ratio (OR)|1.32||||0.0348|2-Sided|95.0|1.02|1.71||Calculated as 2*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo||
1685808|NCT01172821|3101009|Superiority or Other||Odds Ratio (OR)|1.33||||0.0308|2-Sided|95.0|1.03|1.72||Calculated as 2*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo||
1685809|NCT01172821|3101010|Superiority or Other||Mean Difference (Final Values)|0.007|Standard Error of the Mean|0.028||0.8045|2-Sided|95.0|-0.047|0.061|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685810|NCT01172821|3101010|Superiority or Other||Mean Difference (Final Values)|-0.026|Standard Error of the Mean|0.027||0.3501|2-Sided|95.0|-0.079|0.028|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685811|NCT01172821|3101011|Superiority or Other||Mean Difference (Final Values)|0.109|Standard Error of the Mean|0.131||0.4053|2-Sided|95.0|-0.148|0.367|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685812|NCT01172821|3101011|Superiority or Other||Mean Difference (Final Values)|-0.171|Standard Error of the Mean|0.131||0.1927|2-Sided|95.0|-0.427|0.086|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685813|NCT01172821|3101012|Superiority or Other||Mean Difference (Final Values)|0.066|Standard Error of the Mean|0.032||0.0422|2-Sided|95.0|0.002|0.129|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685814|NCT01172821|3101012|Superiority or Other||Mean Difference (Final Values)|0.068|Standard Error of the Mean|0.032||0.0357|2-Sided|95.0|0.005|0.131|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685890|NCT01171989|3101125|Non-Inferiority|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||2-Sided|95.0|-3.27|2.86||||||Difference between groups for rSBA-MenC ≥1:8|
1686017|NCT01168349|3101632|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1685815|NCT01172821|3101013|Superiority or Other||Mean Difference (Final Values)|0.064|Standard Error of the Mean|0.031||0.0395|2-Sided|95.0|0.003|0.126|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685816|NCT01172821|3101013|Superiority or Other||Mean Difference (Final Values)|0.079|Standard Error of the Mean|0.031||0.0111|2-Sided|95.0|0.018|0.14|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685817|NCT01172821|3101014|Superiority or Other||Mean Difference (Final Values)|-0.178|Standard Error of the Mean|0.6||0.7665|2-Sided|95.0|-1.355|0.999|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685818|NCT01172821|3101014|Superiority or Other||Mean Difference (Final Values)|-0.953|Standard Error of the Mean|0.598||0.1114|2-Sided|95.0|-2.125|0.22|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685819|NCT01172821|3101015|Superiority or Other||Mean Difference (Final Values)|21.247|Standard Error of the Mean|4.561|<|0.0001|2-Sided|95.0|12.302|30.193|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685820|NCT01172821|3101015|Superiority or Other||Mean Difference (Final Values)|15.991|Standard Error of the Mean|4.547|<|0.0004|2-Sided|95.0|7.074|24.908|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685821|NCT01172821|3101016|Superiority or Other||Mean Difference (Final Values)|24.757|Standard Error of the Mean|4.513|<|0.0001|2-Sided|95.0|15.907|33.607|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685822|NCT01172821|3101016|Superiority or Other||Mean Difference (Final Values)|20.613|Standard Error of the Mean|4.496|<|0.0001|2-Sided|95.0|11.795|29.431|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685823|NCT01172821|3101017|Superiority or Other||Odds Ratio (OR)|0.98||||1.1727|2-Sided|95.0|0.67|1.42||Calculated as 2*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo||
1685824|NCT01172821|3101017|Superiority or Other||Odds Ratio (OR)|1.19||||0.4012|2-Sided|95.0|0.81|1.74||Calculated as 2*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo||
1685825|NCT01172821|3101018|Superiority or Other||Mean Difference (Final Values)|-0.083|Standard Error of the Mean|0.059||0.1602|2-Sided|95.0|-0.198|0.033|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685826|NCT01172821|3101018|Superiority or Other||Mean Difference (Final Values)|-0.127|Standard Error of the Mean|0.059||0.0305|2-Sided|95.0|-0.241|-0.012|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685827|NCT01172821|3101019|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.068||0.9612|2-Sided|95.0|-0.137|0.13|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685828|NCT01172821|3101019|Superiority or Other||Mean Difference (Final Values)|0.011|Standard Error of the Mean|0.068||0.87|2-Sided|95.0|-0.122|0.144|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685891|NCT01171989|3101126|Non-Inferiority|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||2-Sided|95.0|-3.27|2.84||||||Difference in percentage anti-PRP ≥ 0.15 μg/mL|
1685892|NCT01171690|3101197|Superiority or Other|||||||0.01|||||||Matched pairs t test|||Matched pairs|
1685829|NCT01172821|3101020|Superiority or Other||Mean Difference (Final Values)|28.178|Standard Error of the Mean|4.985|<|0.0001|2-Sided|95.0|18.401|37.956|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685830|NCT01172821|3101020|Superiority or Other||Mean Difference (Final Values)|28.759|Standard Error of the Mean|4.963|<|0.0001|2-Sided|95.0|19.025|38.494|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685831|NCT01172821|3101021|Superiority or Other||Mean Difference (Final Values)|0.089|Standard Error of the Mean|0.029||0.0019|2-Sided|95.0|0.033|0.145|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685832|NCT01172821|3101021|Superiority or Other||Mean Difference (Final Values)|0.108|Standard Error of the Mean|0.029||0.0002|2-Sided|95.0|0.052|0.164|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685833|NCT01172821|3101022|Superiority or Other||Mean Difference (Final Values)|0.163|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.112|0.215|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685834|NCT01172821|3101022|Superiority or Other||Mean Difference (Final Values)|0.201|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.15|0.252|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685835|NCT01172821|3101023|Superiority or Other||Mean Difference (Final Values)|0.083|Standard Error of the Mean|0.032||0.0093|2-Sided|95.0|0.021|0.146|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685836|NCT01172821|3101023|Superiority or Other||Mean Difference (Final Values)|0.087|Standard Error of the Mean|0.032||0.0061|2-Sided|95.0|0.025|0.149|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685837|NCT01172821|3101024|Superiority or Other||Mean Difference (Final Values)|0.089|Standard Error of the Mean|0.03||0.0031|2-Sided|95.0|0.03|0.147|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685838|NCT01172821|3101024|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.03||0.0002|2-Sided|95.0|0.052|0.168|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685839|NCT01172821|3101025|Superiority or Other||Mean Difference (Final Values)|0.133|Standard Error of the Mean|0.029|<|0.0001|2-Sided|95.0|0.076|0.19|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685840|NCT01172821|3101025|Superiority or Other||Mean Difference (Final Values)|0.176|Standard Error of the Mean|0.029|<|0.0001|2-Sided|95.0|0.12|0.233|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685841|NCT01172821|3101026|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.116|0.222|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685893|NCT01171612|3101235|Superiority or Other||Odds Ratio (OR)|1.638||||0.479|2-Sided|95.0|0.733|3.662|||Chi-squared||||
1685894|NCT01171612|3101235|Superiority or Other||Odds Ratio (OR)|1.086||||0.479|2-Sided|95.0|0.513|2.299|||Chi-squared|||Reference group were patients who maintained antiplatelet drugs (aspirin and/or clopidogrel) during the 4 days before surgery|
1685842|NCT01172821|3101026|Superiority or Other||Mean Difference (Final Values)|0.211|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.159|0.264|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685843|NCT01172808|3101029|Superiority or Other||Odds Ratio (OR)|1.32||||0.0348|2-Sided|95.0|1.02|1.71||Calculated as 2*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo||
1685844|NCT01172808|3101029|Superiority or Other||Odds Ratio (OR)|1.33||||0.0308|2-Sided|95.0|1.03|1.72||Calculated as 2*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo||
1685845|NCT01172808|3101030|Superiority or Other||Mean Difference (Final Values)|-0.004|Standard Error of the Mean|0.029||0.888|2-Sided|95.0|-0.061|0.053|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685846|NCT01172808|3101030|Superiority or Other||Mean Difference (Final Values)|0.045|Standard Error of the Mean|0.029||0.1178|2-Sided|95.0|-0.011|0.102|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685847|NCT01172808|3101031|Superiority or Other||Mean Difference (Final Values)|0.144|Standard Error of the Mean|0.14||0.3046|2-Sided|95.0|-0.131|0.419|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685848|NCT01172808|3101031|Superiority or Other||Mean Difference (Final Values)|-0.162|Standard Error of the Mean|0.14||0.2447|2-Sided|95.0|-0.436|0.111|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685849|NCT01172808|3101032|Superiority or Other||Mean Difference (Final Values)|0.039|Standard Error of the Mean|0.031||0.2077|2-Sided|95.0|-0.022|0.1|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685850|NCT01172808|3101032|Superiority or Other||Mean Difference (Final Values)|0.065|Standard Error of the Mean|0.031||0.0363|2-Sided|95.0|0.004|0.126|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685851|NCT01172808|3101033|Superiority or Other||Mean Difference (Final Values)|0.052|Standard Error of the Mean|0.03||0.081|2-Sided|95.0|-0.006|0.111|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685852|NCT01172808|3101033|Superiority or Other||Median Difference (Final Values)|0.081|Standard Error of the Mean|0.03||0.0069|2-Sided|95.0|0.022|0.139|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685853|NCT01172808|3101034|Superiority or Other||Mean Difference (Final Values)|1.58|Standard Error of the Mean|0.608||0.0094|2-Sided|95.0|0.388|2.771|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685854|NCT01172808|3101034|Superiority or Other||Mean Difference (Final Values)|-0.558|Standard Error of the Mean|0.603||0.355|2-Sided|95.0|-1.74|0.624|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685855|NCT01172808|3101035|Superiority or Other||Mean Difference (Final Values)|24.37|Standard Error of the Mean|4.462|<|0.0001|2-Sided|95.0|15.619|33.12|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685895|NCT01171183|3101244|Superiority or Other||Mean Difference (Final Values)|-0.73|Standard Deviation|4.54||0.05|2-Sided||||||t-test, 2 sided||||
1685896|NCT01171183|3101245|Superiority or Other||Median Difference (Final Values)|3.52|Standard Deviation|37.64||0.05|2-Sided||||||t-test, 2 sided||||
1686018|NCT01168349|3101635|Superiority or Other||Risk Ratio (RR)|0.55|||||2-Sided|95.0|0.42|0.71|||||||
1685856|NCT01172808|3101035|Superiority or Other||Mean Difference (Final Values)|28.16|Standard Error of the Mean|4.447|<|0.0001|2-Sided|95.0|19.44|36.88|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685857|NCT01172808|3101036|Superiority or Other||Mean Difference (Final Values)|23.66|Standard Error of the Mean|4.533|<|0.0001|2-Sided|95.0|14.772|32.549|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685858|NCT01172808|3101036|Superiority or Other||Mean Difference (Final Values)|30.591|Standard Error of the Mean|4.52|<|0.0001|2-Sided|95.0|21.726|39.455|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685859|NCT01172808|3101037|Superiority or Other||Odds Ratio (OR)|1.76||||0.0022|2-Sided|95.0|1.22|2.54||Calculated as 2*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo||
1685860|NCT01172808|3101037|Superiority or Other||Odds Ratio (OR)|1.47||||0.0377|2-Sided|95.0|1.02|2.11||Calculated as 2*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R2.5 / Placebo||
1685861|NCT01172808|3101038|Superiority or Other||Mean Difference (Final Values)|-0.133|Standard Error of the Mean|0.06||0.0262|2-Sided|95.0|-0.25|-0.016|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685862|NCT01172808|3101038|Superiority or Other||Mean Difference (Final Values)|-0.202|Standard Error of the Mean|0.059||0.0007|2-Sided|95.0|-0.318|-0.085|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685863|NCT01172808|3101039|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.067||0.2956|2-Sided|95.0|-0.061|0.201|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685864|NCT01172808|3101039|Superiority or Other||Mean Difference (Final Values)|0.073|Standard Error of the Mean|0.066||0.2717|2-Sided|95.0|-0.057|0.203|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685865|NCT01172808|3101040|Superiority or Other||Mean Difference (Final Values)|33.677|Standard Error of the Mean|5.023|<|0.0001|2-Sided|95.0|23.825|43.529|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685866|NCT01172808|3101040|Superiority or Other||Mean Difference (Final Values)|37.907|Standard Error of the Mean|4.994|<|0.0001|2-Sided|95.0|28.113|47.7|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685867|NCT01172808|3101041|Superiority or Other||Mean Difference (Final Values)|0.106|Standard Error of the Mean|0.029||0.0003|2-Sided|95.0|0.049|0.164|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685868|NCT01172808|3101041|Superiority or Other||Mean Difference (Final Values)|0.158|Standard Error of the Mean|0.029|<|0.0001|2-Sided|95.0|0.1|0.215|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685869|NCT01172808|3101042|Superiority or Other||Mean Difference (Final Values)|0.195|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.141|0.249|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685897|NCT01170754|3101258|Non-Inferiority|Inferiority between groups was defined as a difference of 10% in the overall BBPS score.||||||0.98||||||p<.05 was defined as the a priori threshold for statistical significance.|t-test, 2 sided||||
1685976|NCT01169103|3101447|Superiority or Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Change in Triglyceride p-value|
1685870|NCT01172808|3101042|Superiority or Other||Mean Difference (Final Values)|0.224|Standard Error of the Mean|0.027|<|0.0001|2-Sided|95.0|0.171|0.278|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685871|NCT01172808|3101043|Superiority or Other||Mean Difference (Final Values)|0.076|Standard Error of the Mean|0.033||0.02|2-Sided|95.0|0.012|0.14|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685872|NCT01172808|3101043|Superiority or Other||Mean Difference (Final Values)|0.125|Standard Error of the Mean|0.032||0.0001|2-Sided|95.0|0.062|0.189|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, country, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685873|NCT01172808|3101044|Superiority or Other||Mean Difference (Final Values)|0.102|Standard Error of the Mean|0.031||0.0008|2-Sided|95.0|0.042|0.162|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model. Spatial power used as covariance structure. The Kenward-Roger approximation was used to estimate denominator degrees of freedom.|
1685874|NCT01172808|3101044|Superiority or Other||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.03|<|0.0001|2-Sided|95.0|0.114|0.233|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685875|NCT01172808|3101045|Superiority or Other||Mean Difference (Final Values)|0.152|Standard Error of the Mean|0.03|<|0.0001|2-Sided|95.0|0.092|0.211|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction.|
1685876|NCT01172808|3101045|Superiority or Other||Mean Difference (Final Values)|0.185|Standard Error of the Mean|0.03|<|0.0001|2-Sided|95.0|0.126|0.244|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685877|NCT01172808|3101046|Superiority or Other||Mean Difference (Final Values)|0.198|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.142|0.253|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre , week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685878|NCT01172808|3101046|Superiority or Other||Mean Difference (Final Values)|0.236|Standard Error of the Mean|0.028|<|0.0001|2-Sided|95.0|0.181|0.291|||Mixed Models Analysis|Adjusted using a restricted maximum likelihood (REML)-based mixed effects model with repeated measures (MMRM).|Tio R2.5 - Placebo|Analyses included the fixed, categorical effects of treatment, centre, week, and treatment-by-week interaction, as well as the covariates of baseline value and baseline value-by-week interaction. Patient was included as a random effect in the model.|
1685879|NCT01172600|3101064|Superiority or Other||Mean Difference (Final Values)|-1.11||||0.16|2-Sided|98.3|-3.05|0.82|||Mixed Models Analysis|Mixed model with repeated measures, adjusting for VAS pain score at baseline, number of epidural blocks received, and imbalanced baseline variables.|This analysis was per-protocol, using only patients with completed data.||
1685880|NCT01172600|3101065|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.63|2-Sided|98.3|-1.8|1.21|||Mixed Models Analysis|Mixed model with repeated measures, adjusting for VAS pain score at baseline, number of epidural blocks received, and imbalanced baseline variables.|This analysis was per-protocol, using only patients with completed data.||
1685881|NCT01172600|3101066|Superiority or Other||Mean Difference (Final Values)|-1.03||||0.12|2-Sided|95.0|-2.34|0.28|||Regression, Linear||This is a per-protocol analysis, using 68 patients with completed data.||
1685882|NCT01172600|3101066|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.84|2-Sided|95.0|-1.43|1.17|||Regression, Linear|The analysis adjusted for VAS at baseline (before 1st block), number of epidural blocks received, and imbalanced baseline variables.|This is an intention- to-treat analysis. We assigned missing outcomes to 10 patients.||
1685883|NCT01172522|3101077|Superiority or Other||Other|0.0|||=|0|2-Sided||||||Chi-squared||P values above 0.05 is considered statistically insignificant in this study.||
1685884|NCT01172418|3101078|Superiority|||||||0.25|||||||Log Rank||||
1685885|NCT01172418|3101079|Superiority|||||||0.99|||||||Log Rank||||
1685886|NCT01172418|3101080|Superiority|||||||0.37|||||||Log Rank||||
1685887|NCT01172418|3101081|Superiority|||||||0.78|||||||Log Rank||||
1685888|NCT01172145|3101103|Superiority or Other||Mean Difference (Final Values)|-1.385|Standard Error of the Mean|4.86||0.181|2-Sided|95.0|-16.86|3.4|||t-test, 2 sided||||
1685889|NCT01171989|3101125|Non-Inferiority|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10%|Difference in percentage|0.0|||||2-Sided|95.0|-3.02|2.86||||||Difference between groups for rSBA-MenC ≥1:8|
1685967|NCT01169259|3101442|Superiority||Hazard Ratio (HR)|0.83|||||2-Sided|95.0|0.67|1.02|||||||
1685898|NCT01170754|3101259|Equivalence|Equivalence between the two groups was defined as a p-value = or >.05.||||||0.6||||||p<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided||||
1685899|NCT01170754|3101260|Equivalence|Equivalence between the two groups was defined as a p-value = or >.05.||||||0.92||||||p<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided||||
1685900|NCT01170754|3101261|Equivalence|Equivalence between the two groups was defined as a p-value = or >.05.||||||0.75||||||p<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided||||
1685901|NCT01170754|3101262|Equivalence|Equivalence between the two groups was defined as a p-value = or >.05.||||||0.18||||||p<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided||||
1685902|NCT01170754|3101263|Equivalence|Equivalence between the two groups was defined as a p-value = or >.05.||||||0.34|||||||t-test, 2 sided||||
1685903|NCT01170754|3101264|Equivalence|Equivalence between the two groups was defined as a p-value = or >.05.||||||0.47||||||p<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided||||
1685904|NCT01170754|3101265|Equivalence|Equivalence between the two groups was defined as a p-value = or >.05.||||||0.25||||||p<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided||||
1685905|NCT01170754|3101266|Equivalence|Equivalence between the two groups was defined as a p-value = or >.05.||||||0.87||||||p<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided||||
1685906|NCT01170754|3101267|Equivalence|Equivalence between the two groups was defined as a p-value = or >.05.||||||0.31||||||p<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided||||
1685907|NCT01170754|3101268|Equivalence|Equivalence between the two groups was defined as a p-value = or >.05.||||||0.13||||||p<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided||||
1685908|NCT01170754|3101269|Non-Inferiority|Inferiority between the two groups was defined as a difference of 10% in the overall BBPS score||||||0.45||||||p<.05 was defined as the a priori threshold for statistical significance|t-test, 2 sided||||
1685909|NCT01170663|3101272|Superiority or Other (legacy)|||||||0.3973||||||Analysis of covariance (ANCOVA) included treatment group, randomization stratification factors and baseline value of Global Health Status scale.|ANCOVA||||
1685910|NCT01170663|3101280|Superiority or Other (legacy)||Odds Ratio (OR)|2.14||||0.0001|2-Sided|95.0|1.45|3.16|||Cochran-Mantel-Haenszel|Adjusted for stratification factors: geographic region, time-to-progression from the start of first-line therapy and disease measurability.|||
1685911|NCT01170663|3101282|Superiority or Other (legacy)||Hazard Ratio (HR)|0.596|||<|0.0001|2-Sided|95.0|0.494|0.72|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.|||
1685912|NCT01170663|3101283|Superiority or Other (legacy)||Hazard Ratio (HR)|0.635|||<|0.0001|2-Sided|95.0|0.536|0.752|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.|||
1685913|NCT01170663|3101284|Superiority or Other (legacy)||Hazard Ratio (HR)|0.807||||0.0169|2-Sided|95.0|0.678|0.962|||Stratified Log Rank Test|Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.|||
1685914|NCT01170364|3101307|Superiority||||||<|0.004|||||||paired sample t-test, two tailed||||
1685915|NCT01170221|3101311|Superiority or Other||Risk Difference (RD)|1.7|||||2-Sided|95.0|-2.8|6.4|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the Day 7 Visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.|
1685916|NCT01170221|3101312|Superiority or Other||Risk Difference (RD)|3.5|||||2-Sided|95.0|-1.4|8.5|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the Investigator's assessment of clinical response at the 48-72 Hour Visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.|
1685917|NCT01170221|3101313|Non-Inferiority or Equivalence|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.8|||||2-Sided|95.0|-4.6|3.0|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.||
1685918|NCT01170221|3101314|Non-Inferiority or Equivalence|A two-sided 95% CI was calculated for the observed differences in the clinical success rate based on the Investigator's assessment of clinical response at the PTE visit using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.5|||||2-Sided|95.0|-5.8|4.9|||||Risk difference corresponds to the tedizolid clinical success rate minus the linezolid clinical success rate.||
1685919|NCT01170221|3101315|Non-Inferiority or Equivalence|A two-sided 95% CI was calculated for the observed differences in the clinical response rate based on the sustained response at EOT using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-0.9|||||2-Sided|95.0|-7.7|5.4|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.||
1685968|NCT01169259|3101443|Superiority||Hazard Ratio (HR)|0.92|||||2-Sided|95.0|0.8|1.06|||||||
1685969|NCT01169259|3101443|Superiority||Hazard Ratio (HR)|0.97|||||2-Sided|95.0|0.85|1.12|||||||
1685970|NCT01169259|3101444|Superiority||Hazard Ratio (HR)|1.03|||||2-Sided|95.0|0.93|1.13|||||||
1685971|NCT01169259|3101444|Superiority||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.88|1.06|||||||
1685920|NCT01170221|3101316|Non-Inferiority or Equivalence|A two-sided 95% CI will be calculated for the observed differences in the clinical response rate based on the sustained response at EOT using the method of Miettinen and Nurminen with stratification for the presence or absence of fever at baseline. Noninferiority was concluded if the lower limit of the 95% CI was greater than -10% and the conditions of the hierarchical testing procedure were met.|Risk Difference (RD)|-2.6|||||2-Sided|95.0|-9.6|4.2|||||Risk difference corresponds to the tedizolid clinical response rate minus the linezolid clinical response rate.||
1685921|NCT01170221|3101317|Non-Inferiority or Equivalence|A two-sided 95% CI for the observed difference in the primary outcome measure (early clinical response at the 48-72 Hour Visit) between the tedizolid group and the linezolid group was calculated using the ITT analysis set. Noninferiority was concluded if the lower limit of the 95% CI was greater than –10%.|Risk Difference (RD)|0.1||||||95.0|-6.1|6.2|||||Risk difference corresponds to tedizolid clinical response rate minus linezolid clinical response rate. The confidence interval was calculated using the Miettinen and Nurminen with stratification for the presence or absence of fever at baseline.|The primary objective is to determine the noninferiority in the early clinical response rate of oral tedizolid phosphate compared with that of oral linezolid treatment at the 48-72 Hour Visit in the ITT Analysis Set in patients with ABSSSI.|
1685922|NCT01169779|3101360|Superiority or Other||Least squares (LS) mean difference|-0.36|Standard Error of the Mean|0.099||0.0004|2-Sided|95.0|-0.551|-0.162||Statistical testing:2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (<8.0,>=8.0%), sulfonylurea use (Yes,No), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% in change in HbA1c at Week 24 between lixisenatide arm and placebo arm, 190 patients per group would provide a power of 96% assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.|
1685923|NCT01169467|3101405|Superiority or Other|||||||0.395|||||||t-test, 2 sided||||
1685924|NCT01169259|3101421|Superiority||Hazard Ratio (HR)|0.72|||||2-Sided|95.0|0.55|0.93|||||||
1685925|NCT01169259|3101421|Superiority||Hazard Ratio (HR)|0.93|||||2-Sided|95.0|0.71|1.2|||||||
1685926|NCT01169259|3101422|Superiority||Hazard Ratio (HR)|1.1|||||2-Sided|95.0|0.6|2.01|||||||
1685927|NCT01169259|3101422|Superiority||Hazard Ratio (HR)|0.84|||||2-Sided|95.0|0.46|1.54|||||||
1685928|NCT01169259|3101423|Superiority||Hazard Ratio (HR)|0.76|||||2-Sided|95.0|0.49|1.16|||||||
1685929|NCT01169259|3101423|Superiority||Hazard Ratio (HR)|1.27|||||2-Sided|95.0|0.83|1.95|||||||
1685930|NCT01169259|3101424|Superiority||Hazard Ratio (HR)|0.5|||||2-Sided|95.0|0.26|0.97|||||||
1685931|NCT01169259|3101424|Superiority||Hazard Ratio (HR)|1.6|||||2-Sided|95.0|0.84|3.06|||||||
1685932|NCT01169259|3101425|Superiority||Hazard Ratio (HR)|1.32|||||2-Sided|95.0|0.72|2.39|||||||
1685933|NCT01169259|3101425|Superiority||Hazard Ratio (HR)|0.76|||||2-Sided|95.0|0.42|1.38|||||||
1685934|NCT01169259|3101426|Superiority||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.74|1.24|||||||
1685935|NCT01169259|3101426|Superiority||Hazard Ratio (HR)|1.07|||||2-Sided|95.0|0.83|1.39|||||||
1685936|NCT01169259|3101427|Superiority||Hazard Ratio (HR)|0.83|||||2-Sided|95.0|0.71|0.97|||||||
1685937|NCT01169259|3101427|Superiority||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.83|1.12|||||||
1685938|NCT01169259|3101428|Superiority||Hazard Ratio (HR)|0.99|||||2-Sided|95.0|0.73|1.33|||||||
1685939|NCT01169259|3101428|Superiority||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.55|1.01|||||||
1685940|NCT01169259|3101429|Superiority||Hazard Ratio (HR)|0.78|||||2-Sided|95.0|0.63|0.95|||||||
1685941|NCT01169259|3101429|Superiority||Hazard Ratio (HR)|0.97|||||2-Sided|95.0|0.79|1.19|||||||
1685942|NCT01169259|3101430|Superiority||Hazard Ratio (HR)|0.97|||||2-Sided|95.0|0.84|1.12|||||||
1685943|NCT01169259|3101430|Superiority||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.84|1.11|||||||
1685944|NCT01169259|3101431|Superiority||Hazard Ratio (HR)|0.93|||||2-Sided|95.0|0.73|1.19|||||||
1685945|NCT01169259|3101431|Superiority||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.59|0.96|||||||
1685946|NCT01169259|3101432|Superiority||Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.76|1.05|||||||
1685947|NCT01169259|3101432|Superiority||Hazard Ratio (HR)|0.93|||||2-Sided|95.0|0.79|1.09|||||||
1685948|NCT01169259|3101433|Superiority||Hazard Ratio (HR)|1.13|||||2-Sided|95.0|1.0|1.28|||||||
1685949|NCT01169259|3101433|Superiority||Hazard Ratio (HR)|0.94|||||2-Sided|95.0|0.83|1.06|||||||
1685950|NCT01169259|3101434|Superiority||Hazard Ratio (HR)|1.02|||||2-Sided|95.0|0.9|1.15|||||||
1685951|NCT01169259|3101434|Superiority||Hazard Ratio (HR)|0.99|||||2-Sided|95.0|0.87|1.12|||||||
1685952|NCT01169259|3101435|Superiority||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.76|1.21|||||||
1685953|NCT01169259|3101435|Superiority||Hazard Ratio (HR)|1.11|||||2-Sided|95.0|0.88|1.4|||||||
1685954|NCT01169259|3101436|Superiority||Hazard Ratio (HR)|1.04|||||2-Sided|95.0|0.83|1.31|||||||
1685955|NCT01169259|3101436|Superiority||Hazard Ratio (HR)|0.95|||||2-Sided|95.0|0.76|1.2|||||||
1685956|NCT01169259|3101437|Superiority||Hazard Ratio (HR)|0.72|||||2-Sided|95.0|0.59|0.9|||||||
1685957|NCT01169259|3101437|Superiority||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.78|1.19|||||||
1685958|NCT01169259|3101438|Superiority||Hazard Ratio (HR)|0.93|||||2-Sided|95.0|0.82|1.04|||||||
1685959|NCT01169259|3101438|Superiority||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.86|1.08|||||||
1685960|NCT01169259|3101439|Superiority||Hazard Ratio (HR)|1.23|||||2-Sided|95.0|0.83|1.83|||||||
1685961|NCT01169259|3101439|Superiority||Hazard Ratio (HR)|1.09|||||2-Sided|95.0|0.73|1.62|||||||
1685962|NCT01169259|3101440|Superiority||Hazard Ratio (HR)|1.15|||||2-Sided|95.0|0.94|1.39|||||||
1685963|NCT01169259|3101440|Superiority||Hazard Ratio (HR)|0.88|||||2-Sided|95.0|0.72|1.07|||||||
1685964|NCT01169259|3101441|Superiority||Hazard Ratio (HR)|0.9|||||2-Sided|95.0|0.7|1.16|||||||
1685965|NCT01169259|3101441|Superiority||Hazard Ratio (HR)|1.02|||||2-Sided|95.0|0.79|1.31|||||||
1685966|NCT01169259|3101442|Superiority||Hazard Ratio (HR)|0.97|||||2-Sided|95.0|0.79|1.2|||||||
1685977|NCT01169103|3101447|Superiority or Other|||||||0.03|||||||t-test, 2 sided|||Change in Total Cholesterol p-value|
1685978|NCT01169103|3101448|Superiority or Other|||||||0.93|||||||Wilcoxon (Mann-Whitney)||||
1685979|NCT01169103|3101449|Superiority or Other|||||||0.3|||||||t-test, 2 sided|||Change in SAT p-value|
1685980|NCT01169103|3101449|Superiority or Other|||||||0.7|||||||t-test, 2 sided|||We assumed that mean decrease in visceral fat in our population would be 0.85*standard deviation score (SDS). Therefore, 18 subjects in each group would be required in order for us to have an 81.7% chance of detecting a significant difference in the mean 6-month changes in visceral adiposity between the groups at a 5% significance level by rejecting the null hypothesis that there is no difference in change in visceral fat following administration of rhGH or placebo in obese adolescent girls.|
1685981|NCT01169064|3101451|Superiority|||||||0.282|||||||Mixed Models Analysis||||
1685982|NCT01169064|3101452|Superiority or Other|||||||0.365|||||||Chi-squared||||
1685983|NCT01168999|3101457|Superiority or Other||||||>|0.05|||||||Repeated Measure ANOVA||||
1685984|NCT01168999|3101458|Superiority or Other|||||||0.05|||||||Repeated Measure ANOVA||||
1685985|NCT01168999|3101459|Superiority or Other||||||>|0.05|||||||Repeated Measure ANOVA||||
1685986|NCT01168999|3101460|Superiority or Other||||||>|0.05|||||||Repeated Measure ANOVA||||
1685987|NCT01168999|3101461|Superiority or Other|||||||0.01|||||||Chi-squared||||
1685988|NCT01168999|3101462|Superiority or Other||||||<|0.01|||||||Chi-squared||||
1685989|NCT01168986|3101463|Superiority or Other|||||||0.45|||||||Mixed Models Analysis||||
1685990|NCT01168986|3101464|Superiority or Other|||||||0.87|||||||Mixed Models Analysis||||
1685991|NCT01168986|3101465|Superiority or Other|||||||0.18|||||||Mixed Models Analysis||||
1685992|NCT01168986|3101466|Superiority or Other|||||||0.1|||||||Mixed Models Analysis||||
1685993|NCT01168934|3101490|Superiority or Other||Ratio of adjusted geometric means|44.67|||||2-Sided|90.0|40.9|48.78||||||Natural log transformed AUClast(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1685994|NCT01168934|3101493|Superiority or Other||Ratio of adjusted geometric means|43.44|||||2-Sided|90.0|39.68|47.56||||||Natural log transformed AUC (0 - ∞)(dn) of crizotinib was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1685995|NCT01168674|3101559|Superiority or Other||Mean Difference (Net)|1.57|Standard Deviation|1.67||0.48|2-Sided||||||Mixed Models Analysis||The report is of the mean MADRS difference between ziprasidone versus placebo after linear mixed regression, correcting for confounding effects of order of treatment as well as other identified potential confounders.|Linear mixed effects regression model|
1685996|NCT01168596|3101560|Superiority or Other||Slope|-0.06|Standard Error of the Mean|0.82||0.94|2-Sided|95.0|-1.68|1.56|||Regression, Linear||||
1685997|NCT01168596|3101561|Superiority or Other||Slope|0.64|Standard Error of the Mean|0.64||0.31|2-Sided|95.0|-0.62|1.9|||Regression, Linear||||
1685998|NCT01168596|3101562|Superiority or Other||Slope|-0.33|Standard Error of the Mean|0.88||0.71|2-Sided|95.0|-2.06|1.41|||Regression, Linear||||
1685999|NCT01168596|3101563|Superiority or Other||Slope|0.49|Standard Error of the Mean|0.64||0.44|2-Sided|95.0|-0.77|1.76|||Regression, Linear||||
1686000|NCT01168596|3101564|Superiority or Other||Slope|-0.07|Standard Error of the Mean|0.33||0.84|2-Sided|95.0|-0.71|0.58|||Regression, Linear||||
1686001|NCT01168596|3101565|Superiority or Other||Slope|-0.38|Standard Error of the Mean|0.54||0.48|2-Sided|95.0|-1.45|0.69|||Regression, Linear||||
1686002|NCT01168596|3101566|Superiority or Other||Slope|0.04|Standard Error of the Mean|0.54||0.95|2-Sided|95.0|-1.04|1.11|||Regression, Linear||||
1686003|NCT01168596|3101567|Superiority or Other||Slope|2.76|Standard Error of the Mean|4.94||0.58|2-Sided|95.0|-7.02|12.55|||Regression, Linear||||
1686004|NCT01168596|3101568|Superiority or Other||Slope|-2.21|Standard Error of the Mean|2.93||0.45|2-Sided|95.0|-8.02|3.59|||Regression, Linear||||
1686005|NCT01168596|3101569|Superiority or Other||Slope|-4.53|Standard Error of the Mean|7.68||0.56|2-Sided|95.0|-19.74|10.69|||Regression, Linear||||
1686006|NCT01168596|3101570|Superiority or Other||Slope|-0.11|Standard Error of the Mean|0.47||0.82|2-Sided|95.0|-1.05|0.83|||Regression, Linear||||
1686007|NCT01168596|3101571|Superiority or Other||Slope|0.11|Standard Error of the Mean|1.14||0.93|2-Sided|95.0|-2.15|2.36|||Regression, Linear||||
1686008|NCT01168596|3101572|Superiority or Other||Slope|-4.73|Standard Error of the Mean|7.36||0.52|2-Sided|95.0|-19.31|9.85|||Regression, Linear||||
1686009|NCT01168596|3101573|Superiority or Other||Slope|2.27|Standard Error of the Mean|10.02||0.82|2-Sided|95.0|-17.59|22.13|||Regression, Linear||||
1686010|NCT01168596|3101574|Superiority or Other||Slope|0.36|Standard Error of the Mean|0.47||0.44|2-Sided|95.0|-0.56|1.29|||Regression, Linear||||
1686011|NCT01168596|3101575|Superiority or Other||Slope|-5.17|Standard Error of the Mean|6.36||0.42|2-Sided|95.0|-17.76|7.43|||Regression, Linear||||
1686012|NCT01168596|3101576|Superiority or Other||Slope|1.88|Standard Error of the Mean|3.06||0.54|2-Sided|95.0|-4.18|7.94|||Regression, Linear||||
1686013|NCT01168596|3101577|Superiority or Other||Slope|1.61|Standard Error of the Mean|5.03||0.75|2-Sided|95.0|-8.37|11.59|||Regression, Linear||||
1686014|NCT01168596|3101578|Superiority or Other||Slope|4.38|Standard Error of the Mean|3.6||0.23|2-Sided|95.0|-2.75|11.51|||Regression, Linear||||
1686015|NCT01168596|3101579|Superiority or Other||Slope|1.3|Standard Error of the Mean|5.26||0.81|2-Sided|95.0|-9.13|11.73|||Regression, Linear||||
1686016|NCT01168427|3101585|Other|There was no formal statistical hypothesis tested. The goal was to estimate the procedure-related complications 90 days post implant using the Kaplan-Meier method.|Rate|0.034|||||1-Sided|95.0||0.1292|||||||
1686019|NCT01167881|3101655|Superiority or Other||Mean Difference (Net)|-2.8|Standard Error of the Mean|0.4|<|0.0001|2-Sided|97.5|-3.7|-2.0||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline DBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~Non-inferiority in HbA1c change from baseline at 52 weeks,~Superiority in body weight change from baseline at 52 weeks,~Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~Superiority in systolic blood pressure change from baseline at 52 weeks,~Superiority in diastolic blood pressure change from baseline at 52 weeks."|
1686020|NCT01167881|3101656|Superiority or Other||Mean Difference (Net)|-5.8|Standard Error of the Mean|0.6|<|0.0001|2-Sided|97.5|-7.3|-4.4||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline SBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~Non-inferiority in HbA1c change from baseline at 52 weeks,~Superiority in body weight change from baseline at 52 weeks,~Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~Superiority in systolic blood pressure change from baseline at 52 weeks,~Superiority in diastolic blood pressure change from baseline at 52 weeks."|
1686021|NCT01167881|3101657|Superiority or Other||Risk Ratio (RR)|0.077|||<|0.0001|2-Sided|97.5|0.04|0.148||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for baseline HbA1c (<8.5 / >=8.5).||"Testing Hierarchy for first interim analysis (52 weeks):~Non-inferiority in HbA1c change from baseline at 52 weeks,~Superiority in body weight change from baseline at 52 weeks,~Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~Superiority in systolic blood pressure change from baseline at 52 weeks,~Superiority in diastolic blood pressure change from baseline at 52 weeks."|
1686022|NCT01167881|3101658|Superiority or Other||Mean Difference (Net)|-4.81|Standard Error of the Mean|0.16|<|0.0001|2-Sided|97.5|-5.16|-4.46||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline weight, baseline HbA1c as linear covariates.||"Testing Hierarchy for first interim analysis (52 weeks):~Non-inferiority in HbA1c change from baseline at 52 weeks,~Superiority in body weight change from baseline at 52 weeks,~Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~Superiority in systolic blood pressure change from baseline at 52 weeks,~Superiority in diastolic blood pressure change from baseline at 52 weeks."|
1686023|NCT01167881|3101659|Non-Inferiority or Equivalence|Non-inferiority was tested through a two-sided 97.5% confidence interval for the treatment effect of empagliflozin minus the effect of glimepiride in change from baseline in HbA1c. The null-hypothesis of material inferiority of empagliflozin was rejected if the confidence interval is entirely below the non-inferiority margin 0.3%.|Mean Difference (Net)|-0.07|Standard Error of the Mean|0.04|<|0.0001|2-Sided|97.5|-0.16|0.02|||ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for first interim analysis (52 weeks):~Non-inferiority in HbA1c change from baseline at 52 weeks,~Superiority in body weight change from baseline at 52 weeks,~Superiority in occurrence of confirmed hypoglycaemic adverse events at 52 weeks,~Superiority in systolic blood pressure change from baseline at 52 weeks,~Superiority in diastolic blood pressure change from baseline at 52 weeks."|
1686024|NCT01167881|3101660|Superiority or Other||Mean Difference (Net)|-2.7|Standard Error of the Mean|0.4|<|0.0001|2-Sided|97.5|-3.5|-1.8||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline DBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~Non-inferiority in HbA1c change from baseline at 104 weeks,~Superiority in body weight change from baseline at 104 weeks,~Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~Superiority in HbA1c change from baseline at 104 weeks,~Superiority in systolic blood pressure change from baseline at 104 weeks,~Superiority in diastolic blood pressure change from baseline at 104 weeks."|
1686025|NCT01167881|3101661|Superiority or Other||Mean Difference (Net)|-5.6|Standard Error of the Mean|0.6|<|0.0001|2-Sided|97.5|-7.0|-4.2||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline SBP, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~Non-inferiority in HbA1c change from baseline at 104 weeks,~Superiority in body weight change from baseline at 104 weeks,~Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~Superiority in HbA1c change from baseline at 104 weeks,~Superiority in systolic blood pressure change from baseline at 104 weeks,~Superiority in diastolic blood pressure change from baseline at 104 weeks."|
1686026|NCT01167881|3101662|Superiority or Other||Risk Ratio (RR)|0.102|||<|0.0001|2-Sided|97.5|0.06|0.173||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusting for baseline HbA1c (<8.5 / >=8.5).||"Testing Hierarchy for main analysis (104 weeks):~Non-inferiority in HbA1c change from baseline at 104 weeks,~Superiority in body weight change from baseline at 104 weeks,~Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~Superiority in HbA1c change from baseline at 104 weeks,~Superiority in systolic blood pressure change from baseline at 104 weeks,~Superiority in diastolic blood pressure change from baseline at 104 weeks."|
1686048|NCT01167023|3101741|Superiority or Other||Least Squares Mean Difference|-11.26||||0.304||95.0||||Pain rate was analyzed using an analysis of covariance (ANCOVA) model, with baseline pain intensity, treatment group, and stratification variable sickle-cell genotype as explanatory variables.|ANCOVA||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.||
1686027|NCT01167881|3101663|Superiority or Other||Mean Difference (Net)|-0.11|Standard Error of the Mean|0.04||0.0153|2-Sided|97.5|-0.2|-0.01||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for main analysis (104 weeks):~Non-inferiority in HbA1c change from baseline at 104 weeks,~Superiority in body weight change from baseline at 104 weeks,~Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~Superiority in HbA1c change from baseline at 104 weeks,~Superiority in systolic blood pressure change from baseline at 104 weeks,~Superiority in diastolic blood pressure change from baseline at 104 weeks."|
1686028|NCT01167881|3101663|Non-Inferiority or Equivalence|Non-inferiority was tested through a two-sided 97.5% confidence interval for the treatment effect of empagliflozin minus the effect of glimepiride in change from baseline in HbA1c. The null-hypothesis of material inferiority of empagliflozin was rejected if the confidence interval is entirely below the non-inferiority margin 0.3%.|Mean Difference (Net)|-0.11|Standard Error of the Mean|0.04|<|0.0001|2-Sided|97.5|-0.2|-0.01|||ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline HbA1c as linear covariate.||"Testing Hierarchy for main analysis (104 weeks):~Non-inferiority in HbA1c change from baseline at 104 weeks,~Superiority in body weight change from baseline at 104 weeks,~Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~Superiority in HbA1c change from baseline at 104 weeks,~Superiority in systolic blood pressure change from baseline at 104 weeks,~Superiority in diastolic blood pressure change from baseline at 104 weeks."|
1686029|NCT01167881|3101664|Superiority or Other||Mean Difference (Net)|-4.46|Standard Error of the Mean|0.18|<|0.0001|2-Sided|97.5|-4.87|-4.05||The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.|ANCOVA|ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline weight, baseline HbA1c as linear covariates.||"Testing Hierarchy for main analysis (104 weeks):~Non-inferiority in HbA1c change from baseline at 104 weeks,~Superiority in body weight change from baseline at 104 weeks,~Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks,~Superiority in HbA1c change from baseline at 104 weeks,~Superiority in systolic blood pressure change from baseline at 104 weeks,~Superiority in diastolic blood pressure change from baseline at 104 weeks."|
1686030|NCT01167829|3101674|Superiority or Other||Mean Difference (Net)|183.0|Standard Error of the Mean|44.0||0.05|2-Sided|95.0|||||t-test, 2 sided||||
1686031|NCT01167712|3101677|Superiority||Hazard Ratio (HR)|0.94|||||2-Sided|95.0|0.72|1.23|||||||
1686032|NCT01167712|3101678|Superiority||Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.74|1.06||||||Estimated hazard of first progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel.|
1686033|NCT01167582|3101694|Superiority or Other||Risk Ratio (RR)|1.43|||||2-Sided|95.0|0.48|4.22|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|Myocardial Infarction|
1686034|NCT01167582|3101694|Superiority or Other||Risk Ratio (RR)|7.13|||||2-Sided|95.0|0.91|56.02|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)|Mortality|
1686035|NCT01167582|3101695|Superiority or Other||Risk Difference (RD)|9.7||||||95.0|-5.3|24.7|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)||
1686036|NCT01167582|3101696|Superiority or Other||Risk Ratio (RR)|2.38|||||2-Sided|95.0|0.99|5.73|||||Restrictive Arm (numerator) compared to Liberal Arm (denominator)||
1686037|NCT01167582|3101697|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1686038|NCT01167582|3101698|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Day 3 Post Randomization|
1686039|NCT01167582|3101698|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Day 2 Post Randomization|
1686040|NCT01167582|3101698|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Day 1 Post Randomization|
1686041|NCT01167452|3101701|Superiority or Other||Slope|-0.56|Standard Deviation|0.2|<|0.0001|2-Sided||||||Regression, Linear|Multiple Adaptive Regression Spline (MARS)||We conducted a linear regression analysis of the log transformed elimination rate constant vs. the log transformed body mass index for each participant.|
1686042|NCT01167452|3101701|Superiority or Other||Slope|-0.74|Standard Deviation|0.19|<|0.0004|2-Sided||||||Regression, Linear|Multivariate adaptive regression spline (MARS) analysis||We conducted a linear regression analysis of the log transformed elimination rate constant vs. the log transformed weight for each participant.|
1686043|NCT01167426|3101702|Superiority or Other||||||<|0.0001||||||Goodness-of-fit p-value comparing overall preference to expected frequencies of 33.3% in each category. That is, no preference across the full sample of patients in the study.|Chi-squared||||
1686044|NCT01167426|3101703|Superiority or Other||Difference in mean ranks|79.6|||<|0.0001||95.0|||||Wilcoxon Signed-Rank||Difference in mean ranks between Week 2 and Week 6|Comparison of Week 2 (20 mg/1.0 mL utilizing autoject 2 for glass syringe) to Week 6 (20 mg/0.5 mL utilizing the autoject 2 20 mg/0.5 mL).|
1686045|NCT01167023|3101737|Superiority or Other||Least Squares Mean Difference|-128.3|||<|0.001||95.0||||A mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time and time*treatment interaction as fixed effects, and participant as a random effect in the model.|Mixed Models Analysis||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.||
1686046|NCT01167023|3101738|Superiority or Other||Least Squares Mean Difference|-0.56||||0.244||95.0||||Average pain intensity was analyzed using an analysis of covariance (ANCOVA) model, with baseline intensity, treatment group and stratification variable sickle-cell genotype as explanatory variables.|ANCOVA||Least Squares (LS) Mean Difference is for 5 mg prasugrel minus placebo.||
1686047|NCT01167023|3101739|Superiority or Other||Least Squares Mean Difference|-24.051|||<|0.001||95.0||||A mixed-effects model repeated measures analysis with baseline measurement, stratification variable sickle cell genotype, treatment, time, and time*treatment interaction as fixed effects, and participant as a random effect in the model was used.|Mixed Models Analysis||Least Squares Mean Difference is for 5 mg prasugrel minus placebo.||
1686139|NCT01164579|3102061|Superiority or Other||Mean Difference (Final Values)|15.89|Standard Error of the Mean|9.62||0.0985|2-Sided|90.0|0.06|31.73||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6|
1686049|NCT01166568|3101778|Superiority||binomial distribution|0.75||||0.025|1-Sided|97.5|0.75|||the p-value is adjusted for multiple comparisons|Fisher Exact|||"The PSI procedure is defined as successful if 75% of subjects achieve the first primary endpoint or second primary endpoint. The corresponding statistical hypotheses are as follows:~H0 (null hypothesis): p1 ≤ 0.75 Ha (alternative hypothesis): p1 > 0.75, Where, p1 is the probability of subjects achieving the first primary endpoint. H0 (null hypothesis): p2 ≤ 0.75 Ha (alternative hypothesis): p2 > 0.75, Where, p2 is the probability of subjects achieving the second primary endpoint."|
1686050|NCT01166347|3101795|Superiority||Difference in Percentages|1.1||||0.5922|2-Sided|95.0|-8.5|10.8||If p<0.05, then the test is statistically significant.|Regression, Logistic|Treatment as the only independent variable.|Difference = HeartWare - Control|If non-inferiority is established for the primary endpoint, statistical testing for superiority and p-value estimation for the 3 secondary endpoints (incidence of bleeding, incidence of major infection, overall survival) will be performed in a pre-specified sequence and testing will continue at the nominal alpha level until the first non-significant result. This fixed sequence procedure strongly controls the family-wise error rate for the collection of the 3 secondary endpoints.|
1686051|NCT01166347|3101796|Non-Inferiority|The non-inferiority margin was 15%.|Difference in Percentages|3.7||||0.011|1-Sided|95.0||12.56|||Wald test||Difference = Control - HeartWare|Primary endpoint is 2 year survival free from disabling stroke (Modified Rankin Scale >=4), death, exchange, explant due to device malfunction or urgent transplantation. Subjects who are electively transplanted or explanted due to recovery (no disabling stroke) must survive to 2 years post original implant to be considered a success.|
1686052|NCT01166282|3101798|Superiority or Other||Mean Difference (Final Values)|34.8|||=|0|2-Sided|95.0|8.1|61.6|||Fisher Exact||||
1686053|NCT01166282|3101799|Superiority or Other||Mean Difference (Final Values)|27.7|||=|0|2-Sided|95.0|-2.0|57.5|||Fisher Exact||||
1686054|NCT01166282|3101800|Superiority or Other||Mean Difference (Final Values)|11.0|||=|0|2-Sided|95.0|-18.5|40.5|||Fisher Exact||||
1686055|NCT01166282|3101801|Superiority or Other||Mean Difference (Final Values)|-1.12|||=|0|2-Sided|95.0|-4.49|2.26|||1-way ANOVA||||
1686056|NCT01166282|3101802|Superiority or Other||Mean Difference (Final Values)|-3.4|||=|0|2-Sided|95.0|-8.78|1.97|||1-way ANOVA||||
1686057|NCT01166282|3101803|Superiority or Other||Mean Difference (Final Values)|-1.62|||=|0|2-Sided|95.0|-5.32|2.08|||1-way ANOVA||||
1686058|NCT01166282|3101804|Superiority or Other||Mean Difference (Final Values)|-51.17|||=|0|2-Sided|95.0|-99.69|-2.66|||ANCOVA||||
1686059|NCT01166230|3101806|Superiority or Other|||||||0.056|||||||Wilcoxon (Mann-Whitney)||||
1686060|NCT01166230|3101807|Superiority or Other|||||||0.041|||||||Wilcoxon (Mann-Whitney)||||
1686061|NCT01166230|3101808|Superiority or Other|||||||0.141|||||||Fisher Exact||||
1686062|NCT01165775|3101855|Superiority or Other|||||||0.2155|||||||Chi-squared||||
1686063|NCT01165684|3101858|Superiority or Other||Estimated mean|-0.17||||0.224||95.0|-0.45|0.11|||Regression, Linear||||
1686064|NCT01165684|3101859|Superiority or Other||Estimated mean|-0.48||||0.228||95.0|-1.25|0.3|||Regression, Linear||||
1686065|NCT01165684|3101860|Superiority or Other||Estimated mean|0.36||||0.046||95.0|0.01|0.71|||Regression, Linear||||
1686066|NCT01165684|3101863|Superiority or Other||Estimated Mean|0.12||||0.635||95.0|-0.37|0.6|||Regression, Linear||||
1686067|NCT01165684|3101866|Superiority or Other||Odds Ratio (OR)|1.36||||0.146||95.0|0.9|2.07|||Regression, Logistic||||
1686068|NCT01165684|3101867|Superiority or Other||Odds Ratio (OR)|2.38|||<|0.001||95.0|1.56|3.64|||Regression, Logistic||||
1686069|NCT01165684|3101868|Superiority or Other||Odds Ratio (OR)|6.85|||<|0.001||95.0|4.12|11.39|||Regression, Logistic||||
1686070|NCT01165684|3101869|Superiority or Other||Estimated treatment difference, Mean|0.37|||<|0.001||95.0|0.21|0.53|||Regression, Linear||||
1686071|NCT01165684|3101870|Superiority or Other||Estimated treatment difference, Mean|0.55|||<|0.001||95.0|0.42|0.69|||Regression, Linear||||
1686072|NCT01165684|3101871|Non-Inferiority or Equivalence|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% CI was below or equal to 0.4% or equivalently if the p-value for the one-sided test of was less than or equal to 2.5%, where D is the mean treatment difference (step-wise regimen minus basal-bolus regimen).|Estimated treatment difference, Mean|0.14||||0.088||95.0|-0.02|0.3|||Regression, Linear||||
1686073|NCT01165307|3101889|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1686074|NCT01165307|3101893|Superiority or Other|||||||0.42|||||||Wilcoxon (Mann-Whitney)||||
1686075|NCT01165307|3101894|Superiority or Other|||||||0.6|||||||Wilcoxon (Mann-Whitney)||||
1686076|NCT01165307|3101895|Superiority or Other|||||||0.12|||||||Wilcoxon (Mann-Whitney)||||
1686077|NCT01165307|3101896|Superiority or Other|||||||0.38|||||||Wilcoxon (Mann-Whitney)||||
1686078|NCT01165307|3101897|Superiority or Other|||||||0.12|||||||Wilcoxon (Mann-Whitney)||||
1686079|NCT01165307|3101898|Superiority or Other|||||||0.11|||||||t-test, 2 sided|||Comparison between the groups for the SF-12 mental scale.|
1686080|NCT01165307|3101898|Superiority or Other|||||||0.82|||||||t-test, 2 sided|||Comparison between the groups for the SF-12 Physical Scale.|
1686081|NCT01165307|3101899|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)||||
1686096|NCT01165229|3101937|Other|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|39.6||||0.0083|2-Sided|95.0|10.79|64.75|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A >=70YOA group and Zoster-022 Placebo >=70YOA Group|
1686097|NCT01165229|3101937|Other|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of the VE was above 0%|Vaccine efficacy|27.03||||0.3903|2-Sided|95.0|-26.43|73.2|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo >=80YOA Group|
1686140|NCT01164579|3102061|Superiority or Other||Mean Difference (Final Values)|-10.73|Standard Error of the Mean|6.25||0.0859|2-Sided|90.0|-21.02|-0.45||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3|
1686082|NCT01165281|3101906|Non-Inferiority or Equivalence|In order to demonstrate that the upper limit of the confidence interval of intergroup differences in change from baseline is not higher than the noninferiority margin of 1 with a 1-tailed significance level of 0.025 and 90% power, the sample size was calculated to be 133 patients in each group for a total of 266 patients. Assuming approximately 20% of patients would be excluded from the analyses, the target sample size was 330 patients.|Least-Squares Mean Difference|-0.06|Standard Error of the Mean|0.226||0.786|2-Sided|95.0|-0.506|0.383|||ANCOVA|Analysis of covariance (ANCOVA) model was used with treatment and country as factors and baseline pain intensity score as a covariate.||The primary hypothesis to be tested for the study was that the JNS024 ER group was not inferior to oxycodone CR as defined by the upper limit of the 95% confidence interval of the difference between JNS024 ER and oxycodone CR on the mean change from baseline of the NRS pain intensity score during the last 3 days of study drug administration. It was to be concluded that JNS024 ER is not inferior to oxycodone CR if the upper 95% confidence limit is less than 1 point.|
1686083|NCT01165229|3101925|Other|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|30.48||||0.1243|2-Sided|95.0|-10.52|56.27|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A >=70 YOA Group and Zoster-022/006 pooled Placebo>=70 YOA Group|
1686084|NCT01165229|3101925|Other|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|54.93||||0.194|2-Sided|95.0|-50.03|86.46|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A >=80 YOA Group and Zoster-022/006 pooled Placebo >=80 YOA Group|
1686085|NCT01165229|3101925|Other|The VE of HZ/su against duration of severe worst pain in subjects with confirmed HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|23.75||||0.2885|2-Sided|95.0|-25.8|53.78|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022/006 pooled GSK1437173A 70-79YOA Group and Zoster-022/006 pooled Placebo 70-79YOA Group|
1686086|NCT01165229|3101926|Other|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|0.29||||0.5417|2-Sided|95.0|-161.53|65.57|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A >=50 YOA Group versus Zoster-022/006 Pooled Placebo >=50 YOA Group|
1686087|NCT01165229|3101926|Other|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|-223.81||||0.1528|2-Sided|95.0|-883.05|18.84|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A >=80 YOA Group versus Zoster-022/006 Pooled Placebo>=80 YOA Group|
1686088|NCT01165229|3101926|Other|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|21.6||||1|2-Sided|95.0|-149.41|78.91|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group versus Zoster-022/006 Pooled Placebo 70-79 YOA Group|
1686089|NCT01165229|3101926|Other|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||1|2-Sided|95.0|-3938.7|100.0|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group versus Zoster-022/006 Pooled Placebo 60-69 YOA Group|
1686090|NCT01165229|3101926|Other|The efficacy of HZ/su vaccine in reduction of PHN in subjects with confirmed HZ episodes was demonstrated if the LL of the two-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||1|2-Sided|95.0|-649.86|100.0|||Poisson exact test|||Comparison of Vaccine efficacy in reduction of PHN incidence in subjects with confirmed HZ episode in Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group versus Zoster-022/006 Pooled Placebo 50-59 YOA Group|
1686091|NCT01165229|3101927|Other|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||0.5097|2-Sided|95.0|-442.83|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 60-69YOA Group and Zoster-022/006 Pooled Placebo 60-69YOA Group|
1686092|NCT01165229|3101927|Other|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|100.0||||0.0081|2-Sided|95.0|40.88|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A 50-59YOA Group and Zoster-022/006 Pooled Placebo 50-59YOA Group.Comparison of vaccine efficacy for groups 70-79 and above 80 YOA are presented in outcome measure 2.|
1686093|NCT01165229|3101936|Other|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|49.25||||0.0404|2-Sided|95.0|2.92|73.47|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A >=70YOA Group and Zoster-022 Placebo >=70YOA Group|
1686094|NCT01165229|3101936|Other|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|-14.56||||0.8324|2-Sided|95.0|-303.3|67.46|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo >=80YOA Group|
1686095|NCT01165229|3101936|Other|Efficacy of the HZ/su vaccine against duration of pain medication associated with HZ was demonstrated if the LL of the two-sided 95% CI of VE derived from the hazard ratio was above 0%.|Vaccine efficacy|58.94||||0.0232|2-Sided|95.0|11.45|80.96|||Poisson exact test|||Comparison of VE in reduction in duration of pain medication associated with HZ between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group|
1688040|NCT01145898|3104746|Superiority or Other|||||||0.2383|||||||ANCOVA||||
1686098|NCT01165229|3101937|Other|Efficacy of the HZ/su vaccine against use of pain medications was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|43.42||||0.0112|2-Sided|95.0|10.77|70.53|||Poisson exact test|||Comparison of VE in reduction in use of pain medication between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group|
1686099|NCT01165229|3101938|Other|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%|Vaccine efficacy|0.97||||1|2-Sided|95.0|-433.32|83.16|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A >=70YOA Group and Zoster-022 Placebo >=70YOA Group|
1686100|NCT01165229|3101938|Other|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%|Vaccine efficacy|100.0||||1|2-Sided|95.0|-558.05|100.0|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo >=80YOA Group|
1686101|NCT01165229|3101938|Other|Efficacy of the HZ/su vaccine against HZ related complications was demonstrated if the LL of the VE was above 0%.|Vaccine efficacy|-65.69||||0.4947|2-Sided|95.0|-827.06|73.62|||Poisson exact test|||Comparison of VE in reduction of HZ related complications between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group|
1686102|NCT01165229|3101939|Other|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.0636|2-Sided|95.0|-9.92|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A >=70YOA Group and Zoster-022 Placebo >=70YOA Group|
1686103|NCT01165229|3101939|Other|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.5024|2-Sided|95.0|-435.14|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo >=80YOA Group|
1686104|NCT01165229|3101939|Other|Efficacy of the HZ/su vaccine against overall and HZ related hospitalizations was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|100.0||||0.2533|2-Sided|95.0|-144.13|100.0|||Poisson exact test|||Comparison of VE in reduction of overall and HZ related hospitalizations between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group|
1686105|NCT01165229|3101942|Other|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|28.4||||0.1877|2-Sided|95.0|-17.69|56.44|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A >=70YOA Group and Zoster-022 Placebo>=70YOA Group|
1686106|NCT01165229|3101942|Other|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|51.76||||0.2466|2-Sided|95.0|-65.55|85.95|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo>=80YOA Group|
1686107|NCT01165229|3101942|Other|The efficacy of HZ/su vaccine against duration of severe worst HZ associated pain was demonstrated if the LL of the two-sided 95% CI of VE derived from the Hazard ratio was above 0%.|Vaccine efficacy|21.7||||0.3749|2-Sided|95.0|-34.4|54.39|||Poisson exact test|||Comparison of VE in reduction of duration of severe worst HZ associated pain between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 Placebo 70-79YOA Group|
1686108|NCT01165229|3101943|Other|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|85.49|||<|0.0001|2-Sided|95.0|58.52|96.3|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A >=70YOA Group and Zoster-022 Placebo >=70YOA Group|
1686109|NCT01165229|3101943|Other|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|65.76|||<|0.3072|2-Sided|95.0|-91.58|96.62|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo >=80YOA Group|
1686110|NCT01165229|3101943|Other|The efficacy of HZ/su vaccine against PHN was demonstrated if the LL of the two-sided 95% CI of VE was above 0%.|Vaccine efficacy|90.8|||<|0.0001|2-Sided|95.0|62.57|98.95|||Poisson exact test|||Comparison of of Vaccine Efficacy (VE) in prevention of PHN between Zoster-022 GSK1437173A 70-79YOA Group and Zoster-022 placebo 70-79YOA Group|
1686111|NCT01165229|3101944|Other|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.3|||<|0.0001|2-Sided|95.0|86.88|94.46|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 pooled GSK1437173A >=70 YOA Group and Zoster-022/006 Pooled Placebo >=70YOA Group|
1686112|NCT01165229|3101944|Other|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.37|||<|0.0001|2-Sided|95.0|80.22|96.94|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A >=80YOA Group and Zoster-022/006 Pooled Placebo >=80YOA Group|
1686113|NCT01165229|3101944|Other|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|91.27|||<|0.0001|2-Sided|95.0|86.04|94.85|||Poisson exact test|||Comparison of vaccine efficacy in prevention of herpes zoster disease between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group|
1686114|NCT01165229|3101945|Other|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|88.78|||<|0.0001|2-Sided|95.0|68.7|97.1|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A >=70YOA Group and Zoster-022/006 Pooled Placebo >=70YOA Group|
1686115|NCT01165229|3101945|Other|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|71.16|||<|0.1844|2-Sided|95.0|-51.51|97.08|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between Zoster-022/006 Pooled GSK1437173A >=80YOA Group and Zoster-022/006 Pooled Placebo >=80YOA Group|
1686116|NCT01165229|3101945|Other|The efficacy of HZ/su vaccine against PHN was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 0%|Vaccine efficacy|93.04|||<|0.0001|2-Sided|95.0|72.47|99.19|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Post-Herpetic Neuralgia (PHN) between Zoster-022/006 Pooled GSK1437173A 70-79YOA Group and Zoster-022/006 Pooled Placebo 70-79YOA Group|
1686117|NCT01165229|3101946|Other|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|89.79|||<|0.0001|2-Sided|95.0|84.29|93.66|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A >=70YOA Group and Zoster-022 Placebo >=70YOA Group|
1686118|NCT01165229|3101946|Other|The efficacy of HZ/su vaccine against herpes zoster disease was demonstrated if the lower limit of the of the 2-sided 95% CI of VE was above 10%|Vaccine efficacy|89.08|||<|0.0001|2-Sided|95.0|74.65|96.16|||Poisson exact method|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A >=80YOA Group and Zoster-022 Placebo Zoster-022 Placebo >=80YOA Group|
1686119|NCT01165229|3101946|Other|The efficacy of Herpes Zoster subunit (HZ/su) vaccine against herpes zoster disease was demonstrated if the lower limit (LL) of the two-sided 95% Confidence Interval (CI) of VE was above 10%.|Vaccine efficacy|90.02|||<|0.0001|2-Sided|95.0|83.54|94.32|||Poisson exact test|||Comparison of vaccine efficacy in prevention of Herpes Zoster (HZ) disease between Zoster-022 GSK1437173A 70-79 YOA group and Zoster-022 Placebo 70-79 YOA group.|
1686120|NCT01165177|3102003|Other|Criteria for the VE objective of HZ/su vaccine against PHN in the overall ages strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0|||<|0.0001|2-Sided|95.0|77.1|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A overall ages group and placebo overall ages group|
1686121|NCT01165177|3102003|Other|Criteria for the VE objective of HZ/su vaccine against PHN in the 70-79 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0|||<|0.0078|2-Sided|95.0|41.4|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A over 70 YOA group and placebo over 70 YOA group|
1686122|NCT01165177|3102003|Other|Criteria for VE objective of HZ/su vaccine against PHN in the 60-69 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0|||<|0.5097|2-Sided|95.0|-442.8|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 60-69 YOA group and placebo 60-69 YOA group|
1686123|NCT01165177|3102003|Other|Criteria for the VE objective of HZ/su vaccine against PHN in the 50-59 YOA strata: The lower limit of the 95% CI of VE had to be above 0%|Vaccine efficacy|100.0|||<|0.0081|2-Sided|95.0|40.9|100.0|||Poisson exact test|||Comparison of vaccine efficacy in prevention of PHN between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group|
1686124|NCT01165177|3102004|Other|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the overall age strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.2|||<|0.0001|2-Sided|95.0|93.7|99.0||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A overall ages group and placebo overall ages group|
1686125|NCT01165177|3102004|Other|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 70-79 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.9|||<|0.0001|2-Sided|95.0|87.9|100.0||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 70 YOA group and placebo over 70 YOA group|
1686126|NCT01165177|3102004|Other|Criteria for the VE objective of HZ/su vaccine against herpes zoster disease, in the 60-69 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|97.4|||<|0.0001|2-Sided|95.0|90.1|99.7||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A over 60-69 YOA group and placebo over 60-69 YOA group|
1686127|NCT01165177|3102004|Other|Criteria for the vaccine efficacy (VE) objective of herpes zoster subunit (HZ/su) vaccine against herpes zoster (HZ) disease, in the 50-59 YOA strata : The lower limit (LL) of the two-sided 95% confidence interval (CI) of VE had to be above 10%.|Vaccine efficacy|96.6|||<|0.0001|2-Sided|95.0|89.6|99.3||Two sided exact P-value conditional to number of cases.|Poisson exact test|||Comparison of vaccine efficacy in prevention of HZ between GSK1437173A 50-59 YOA group and placebo 50-59 YOA group|
1686128|NCT01165138|3102021|Superiority or Other||Mean Difference (Final Values)|0.116||||0.06|2-Sided|95.0|-0.005|0.236|||ANCOVA||||
1686129|NCT01165138|3102021|Superiority or Other||Median Difference (Final Values)|0.302|||<|0.001|2-Sided|95.0|0.178|0.426|||ANCOVA||||
1686130|NCT01165138|3102021|Superiority or Other||Median Difference (Final Values)|0.186|||<|0.003|2-Sided|95.0|0.062|0.31|||ANCOVA||||
1686131|NCT01165138|3102022|Superiority or Other||Median Difference (Final Values)|0.036||||0.405|2-Sided|95.0|-0.048|0.12|||ANCOVA||||
1686132|NCT01165138|3102022|Superiority or Other||Median Difference (Final Values)|0.172|||<|0.001|2-Sided|95.0|0.087|0.258|||ANCOVA||||
1686133|NCT01165138|3102022|Superiority or Other||Median Difference (Final Values)|0.136|||<|0.002|2-Sided|95.0|0.051|0.222|||ANCOVA||||
1686134|NCT01164579|3102061|Superiority or Other||Mean Difference (Final Values)|5.93|Standard Error of the Mean|8.66||0.4937|2-Sided|90.0|-8.32|20.18||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12|
1686135|NCT01164579|3102061|Superiority or Other||Mean Difference (Final Values)|18.83|Standard Error of the Mean|9.79||0.0544|2-Sided|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12|
1686136|NCT01164579|3102061|Superiority or Other||Mean Difference (Final Values)|-2.32|Standard Error of the Mean|8.36||0.7807|2-Sided|90.0|-16.08|11.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9|
1686137|NCT01164579|3102061|Superiority or Other||Mean Difference (Final Values)|19.07|Standard Error of the Mean|10.19||0.0612|2-Sided|90.0|2.31|35.84||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9|
1686138|NCT01164579|3102061|Superiority or Other||Mean Difference (Final Values)|0.37|Standard Error of the Mean|8.05||0.9628|2-Sided|90.0|-12.86|13.61||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6|
1686141|NCT01164579|3102061|Superiority or Other||Mean Difference (Final Values)|10.01|Standard Error of the Mean|9.19||0.2759|2-Sided|90.0|-5.1|25.13||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3|
1686142|NCT01164579|3102061|Superiority or Other||Mean Difference (Final Values)|2.85|Standard Error of the Mean|4.65||0.54|2-Sided|90.0|-4.8|10.51||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2|
1686143|NCT01164579|3102061|Superiority or Other||Mean Difference (Final Values)|14.94|Standard Error of the Mean|7.06||0.0342|2-Sided|90.0|3.32|26.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2|
1686144|NCT01164579|3102061|Superiority or Other||Mean Difference (Final Values)|2.85|Standard Error of the Mean|2.81||0.3102|2-Sided|90.0|-1.77|7.48||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1|
1686145|NCT01164579|3102061|Superiority or Other||Mean Difference (Final Values)|5.88|Standard Error of the Mean|4.03||0.1449|2-Sided|90.0|-0.75|12.52||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1|
1686146|NCT01164579|3102062|Superiority or Other||Mean Difference (Net)|14.33|Standard Error of the Mean|9.78||0.1426|2-Sided|90.0|-1.74|30.42||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12|
1686147|NCT01164579|3102062|Superiority or Other||Mean Difference (Final Values)|33.78|Standard Error of the Mean|10.49||0.0012|2-Sided|90.0|16.51|51.05||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12|
1686148|NCT01164579|3102062|Superiority or Other||Mean Difference (Final Values)|14.41|Standard Error of the Mean|10.15||0.1558|2-Sided|90.0|-2.29|31.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9|
1686149|NCT01164579|3102062|Superiority or Other||Mean Difference (Final Values)|25.19|Standard Error of the Mean|10.67||0.0182|2-Sided|90.0|7.63|42.76||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9|
1686150|NCT01164579|3102062|Superiority or Other||Mean Difference (Final Values)|8.85|Standard Error of the Mean|9.85||0.3688|2-Sided|90.0|-7.35|25.07||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6|
1686151|NCT01164579|3102062|Superiority or Other||Mean Difference (Final Values)|22.25|Standard Error of the Mean|10.61||0.036|2-Sided|90.0|4.79|39.72||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6|
1686152|NCT01164579|3102062|Superiority or Other||Mean Difference (Final Values)|17.04|Standard Error of the Mean|9.51||0.0732|2-Sided|90.0|1.39|32.69||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3|
1686153|NCT01164579|3102062|Superiority or Other||Mean Difference (Final Values)|18.83|Standard Error of the Mean|9.79||0.0544|2-Sided|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3|
1686154|NCT01164579|3102062|Superiority or Other||Mean Difference (Final Values)|5.78|Standard Error of the Mean|7.3||0.4287|2-Sided|90.0|-6.23|17.79||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2|
1686155|NCT01164579|3102062|Superiority or Other||Mean Difference (Final Values)|27.18|Standard Error of the Mean|9.34||0.0036|2-Sided|90.0|11.81|42.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2|
1686156|NCT01164579|3102062|Superiority or Other||Mean Difference (Final Values)|5.86|Standard Error of the Mean|5.43||0.2798|2-Sided|90.0|-3.06|14.8||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1|
1686157|NCT01164579|3102062|Superiority or Other||Mean Difference (Final Values)|17.88|Standard Error of the Mean|7.42||0.016|2-Sided|90.0|5.66|30.1||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1|
1686158|NCT01164579|3102063|Superiority or Other||Mean Difference (Final Values)|23.49|Standard Error of the Mean|11.22||0.0363|2-Sided|90.0|5.02|41.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12|
1686159|NCT01164579|3102063|Superiority or Other||Mean Difference (Final Values)|33.46|Standard Error of the Mean|10.73||0.0018|2-Sided|90.0|15.8|51.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12|
1686160|NCT01164579|3102063|Superiority or Other||Mean Difference (Final Values)|26.27|Standard Error of the Mean|11.08||0.0177|2-Sided|90.0|8.04|44.5|||Normal approximation to the binomial|||Month 9|
1686161|NCT01164579|3102063|Superiority or Other||Mean Difference (Final Values)|36.4|Standard Error of the Mean|10.48||0.0005|2-Sided|90.0|19.16|53.64||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9|
1686162|NCT01164579|3102063|Superiority or Other||Mean Difference (Final Values)|26.42|Standard Error of the Mean|10.74||0.0139|2-Sided|90.0|8.74|44.1||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6|
1686163|NCT01164579|3102063|Superiority or Other||Mean Difference (Final Values)|33.94|Standard Error of the Mean|10.21||0.0008|2-Sided|90.0|17.13|50.75||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6|
1686164|NCT01164579|3102063|Superiority or Other||Mean Difference (Final Values)|18.09|Standard Error of the Mean|11.24||0.1076|2-Sided|90.0|-0.4|36.59||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3|
1686165|NCT01164579|3102063|Superiority or Other||Mean Difference (Final Values)|39.82|Standard Error of the Mean|9.54|<|0.0001|2-Sided|90.0|24.11|55.53||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3|
1686166|NCT01164579|3102063|Superiority or Other||Mean Difference (Final Values)|9.98|Standard Error of the Mean|11.13|<|0.37|2-Sided|90.0|-8.33|28.3||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2|
1686167|NCT01164579|3102063|Superiority or Other||Mean Difference (Final Values)|25.83|Standard Error of the Mean|10.1|<|0.0105|2-Sided|90.0|9.21|42.45||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2|
1686168|NCT01164579|3102063|Superiority or Other||Mean Difference (Final Values)|33.12|Standard Error of the Mean|11.09|<|0.0028|2-Sided|90.0|14.87|51.38||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1|
1686169|NCT01164579|3102063|Superiority or Other||Mean Difference (Final Values)|37.91|Standard Error of the Mean|10.99|<|0.0005|2-Sided|90.0|19.83|55.99||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1|
1686170|NCT01164579|3102064|Superiority or Other||Mean Difference (Final Values)|19.81|Standard Error of the Mean|9.66||0.0401|2-Sided|90.0|3.92|35.71||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12|
1688041|NCT01145898|3104747|Superiority or Other|||||||0.2383|||||||ANCOVA||||
1686171|NCT01164579|3102064|Superiority or Other||Mean Difference (Final Values)|33.54|Standard Error of the Mean|10.24||0.001|2-Sided|90.0|16.7|50.39||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12|
1686172|NCT01164579|3102064|Superiority or Other||Mean Difference (Final Values)|19.96|Standard Error of the Mean|10.36||0.054|2-Sided|90.0|2.91|37.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9|
1686173|NCT01164579|3102064|Superiority or Other||Mean Difference (Final Values)|31.08|Standard Error of the Mean|10.72||0.0037|2-Sided|90.0|13.44|48.72||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9|
1686174|NCT01164579|3102064|Superiority or Other||Mean Difference (Final Values)|17.11|Standard Error of the Mean|9.92||0.0845|2-Sided|90.0|0.79|33.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6|
1686175|NCT01164579|3102064|Superiority or Other||Mean Difference (Final Values)|30.84|Standard Error of the Mean|10.48||0.0032|2-Sided|90.0|13.59|48.09||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6|
1686176|NCT01164579|3102064|Superiority or Other||Mean Difference (Final Values)|8.7|Standard Error of the Mean|8.92||0.329|2-Sided|90.0|-5.96|23.38||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3|
1686177|NCT01164579|3102064|Superiority or Other||Mean Difference (Final Values)|18.83|Standard Error of the Mean|9.79||0.0544|2-Sided|90.0|2.72|34.95||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3|
1686178|NCT01164579|3102064|Superiority or Other||Mean Difference (Final Values)|8.55|Standard Error of the Mean|7.66||0.264|2-Sided|90.0|-4.04|21.16||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2|
1686179|NCT01164579|3102064|Superiority or Other||Mean Difference (Final Values)|27.18|Standard Error of the Mean|9.34||0.0036|2-Sided|90.0|11.81|42.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2|
1686180|NCT01164579|3102064|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|5.4||0.9544|2-Sided|90.0|-8.58|9.19||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1|
1686181|NCT01164579|3102064|Superiority or Other||Mean Difference (Final Values)|12.77|Standard Error of the Mean|7.67||0.0959|2-Sided|90.0|0.15|25.4||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1|
1686182|NCT01164579|3102065|Superiority or Other||Mean Difference (Final Values)|22.97|Standard Error of the Mean|11.07||0.0381|2-Sided|90.0|4.74|41.19||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12|
1686183|NCT01164579|3102065|Superiority or Other||Mean Difference (Final Values)|34.73|Standard Error of the Mean|11.07||0.0017|2-Sided|90.0|16.51|52.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12|
1686184|NCT01164579|3102065|Superiority or Other||Mean Difference (Final Values)|28.6|Standard Error of the Mean|11.13||0.0102|2-Sided|90.0|10.28|46.91||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9|
1686185|NCT01164579|3102065|Superiority or Other||Mean Difference (Final Values)|34.97|Standard Error of the Mean|11.11||0.0016|2-Sided|90.0|16.68|53.26||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9|
1686186|NCT01164579|3102065|Superiority or Other||Mean Difference (Final Values)|28.52|Standard Error of the Mean|11.04||0.0097|2-Sided|90.0|10.36|46.69||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6|
1686187|NCT01164579|3102065|Superiority or Other||Mean Difference (Final Values)|34.73|Standard Error of the Mean|11.07||0.0017|2-Sided|90.0|16.51|52.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6|
1686188|NCT01164579|3102065|Superiority or Other||Mean Difference (Final Values)|20.04|Standard Error of the Mean|10.64||0.0596|2-Sided|90.0|2.53|37.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3|
1686189|NCT01164579|3102065|Superiority or Other||Mean Difference (Final Values)|28.37|Standard Error of the Mean|10.92||0.0093|2-Sided|90.0|10.4|46.34||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3|
1686190|NCT01164579|3102065|Superiority or Other||Mean Difference (Final Values)|14.48|Standard Error of the Mean|10.48||0.1669|2-Sided|90.0|-2.75|31.73||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2|
1686191|NCT01164579|3102065|Superiority or Other||Mean Difference (Final Values)|28.37|Standard Error of the Mean|10.92||0.0093|2-Sided|90.0|10.4|46.34||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2|
1686192|NCT01164579|3102065|Superiority or Other||Mean Difference (Final Values)|6.33|Standard Error of the Mean|8.16||0.4379|2-Sided|90.0|-7.09|19.76||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1|
1686193|NCT01164579|3102065|Superiority or Other||Mean Difference (Final Values)|22.52|Standard Error of the Mean|9.66||0.0197|2-Sided|90.0|6.62|38.42||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1|
1686194|NCT01164579|3102066|Superiority or Other||Mean Difference (Final Values)|26.27|Standard Error of the Mean|11.08||0.0177|2-Sided|90.0|8.04|44.5||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12|
1686195|NCT01164579|3102066|Superiority or Other||Mean Difference (Final Values)|36.4|Standard Error of the Mean|10.48||0.0005|2-Sided|90.0|19.16|53.64||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 12|
1686196|NCT01164579|3102066|Superiority or Other||Mean Difference (Final Values)|23.49|Standard Error of the Mean|11.22||0.0363|2-Sided|90.0|5.02|41.96||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9|
1686197|NCT01164579|3102066|Superiority or Other||Mean Difference (Final Values)|33.46|Standard Error of the Mean|10.73||0.0018|2-Sided|90.0|15.8|51.12||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 9|
1686198|NCT01164579|3102066|Superiority or Other||Mean Difference (Final Values)|23.72|Standard Error of the Mean|10.73||0.027|2-Sided|90.0|6.07|41.37||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6|
1686199|NCT01164579|3102066|Superiority or Other||Mean Difference (Final Values)|34.18|Standard Error of the Mean|9.88||0.0005|2-Sided|90.0|17.92|50.43||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 6|
1686200|NCT01164579|3102066|Superiority or Other||Mean Difference (Final Values)|21.02|Standard Error of the Mean|10.69||0.0493|2-Sided|90.0|3.43|38.61||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3|
1686201|NCT01164579|3102066|Superiority or Other||Mean Difference (Final Values)|34.41|Standard Error of the Mean|9.48||0.0002|2-Sided|90.0|18.81|50.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 3|
1686202|NCT01164579|3102066|Superiority or Other||Mean Difference (Final Values)|23.79|Standard Error of the Mean|10.48||0.0231|2-Sided|90.0|6.55|41.03||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2|
1686203|NCT01164579|3102066|Superiority or Other||Mean Difference (Final Values)|34.41|Standard Error of the Mean|9.48||0.0002|2-Sided|90.0|18.81|50.02||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 2|
1686204|NCT01164579|3102066|Superiority or Other||Mean Difference (Final Values)|28.18|Standard Error of the Mean|11.16||0.0115|2-Sided|90.0|9.81|46.55||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1|
1686205|NCT01164579|3102066|Superiority or Other||Mean Difference (Final Values)|32.51|Standard Error of the Mean|11.04||0.0032|2-Sided|90.0|14.34|50.68||2-sided p-value; alpha=0.10|Normal approximation to the binomial|||Month 1|
1686206|NCT01164579|3102067|Superiority or Other||Difference in LS Means|-0.66|Standard Error of the Mean|0.33||0.0466|2-Sided|90.0|-1.21|-0.12||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686207|NCT01164579|3102067|Superiority or Other||Difference in LS Means|-1.13|Standard Error of the Mean|0.33||0.0008|2-Sided|90.0|-1.67|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686208|NCT01164579|3102067|Superiority or Other||Difference in LS Means|-0.58|Standard Error of the Mean|0.32||0.0706|2-Sided|90.0|-1.1|-0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9|
1686209|NCT01164579|3102067|Superiority or Other||Difference in LS Means|-1.15|Standard Error of the Mean|0.32||0.0004|2-Sided|90.0|-1.67|-0.62||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9|
1686210|NCT01164579|3102067|Superiority or Other||Difference in LS Means|-1.08|Standard Error of the Mean|0.31||0.0006|2-Sided|90.0|-1.59|-0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686211|NCT01164579|3102067|Superiority or Other||Difference in LS Means|-1.29|Standard Error of the Mean|0.31|<|0.0001|2-Sided|90.0|-1.81|-0.78||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686212|NCT01164579|3102067|Superiority or Other||Difference in LS Means|-0.55|Standard Error of the Mean|0.3|<|0.0683|2-Sided|90.0|-1.05|-0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3|
1686213|NCT01164579|3102067|Superiority or Other||Difference in LS Means|-0.89|Standard Error of the Mean|0.3|<|0.0035|2-Sided|90.0|-1.39|-0.39||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3|
1686214|NCT01164579|3102067|Superiority or Other||Difference in LS Means|-0.67|Standard Error of the Mean|0.3|<|0.0255|2-Sided|90.0|-1.17|-0.18||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2|
1686215|NCT01164579|3102067|Superiority or Other||Difference in LS Means|-1.18|Standard Error of the Mean|0.3|<|0.0001|2-Sided|90.0|-1.69|-0.68||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2|
1686216|NCT01164579|3102067|Superiority or Other||Difference in LS Means|-0.63|Standard Error of the Mean|0.29|<|0.0303|2-Sided|90.0|-1.11|-0.15||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1|
1686217|NCT01164579|3102067|Superiority or Other||Difference in LS Means|-0.84|Standard Error of the Mean|0.29|<|0.0046|2-Sided|90.0|-1.32|-0.35||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1|
1686218|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|-0.66|||||2-Sided|90.0|-1.43|0.11||||||Month 12|
1686219|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|-1.11|||||2-Sided|90.0|-1.84|-0.39||||||Month 12|
1686220|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|-0.59|||||2-Sided|90.0|-1.3|0.13||||||Month 9|
1686221|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|-1.11|||||2-Sided|90.0|-1.84|-0.39||||||Month 9|
1686222|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|-1.24|||||2-Sided|90.0|-1.91|-0.57||||||Month 6|
1686223|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|-1.43|||||2-Sided|90.0|-2.13|-0.72||||||Month 6|
1686224|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|-0.51|||||2-Sided|90.0|-1.12|0.11||||||Month 3|
1686225|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|-0.96|||||2-Sided|90.0|-1.55|-0.38||||||Month 3|
1686226|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|-0.69|||||2-Sided|90.0|-1.25|-0.13||||||Month 2|
1686227|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|-1.28|||||2-Sided|90.0|-1.82|-0.73||||||Month 2|
1686228|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|-0.58|||||2-Sided|90.0|-1.01|-0.14||||||Month 1|
1686229|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|-0.91|||||2-Sided|90.0|-1.4|-0.42||||||Month 1|
1686230|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|0.06|||||2-Sided|90.0|-0.24|0.36||||||Baseline|
1686231|NCT01164579|3102068|Superiority or Other||Mean Difference (Final Values)|-0.19|||||2-Sided|90.0|-0.53|0.15||||||Baseline|
1686232|NCT01164579|3102069|Superiority or Other||Difference in LS Means|-0.84|Standard Error of the Mean|0.3||0.0049|2-Sided|90.0|-1.32|-0.35||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686233|NCT01164579|3102069|Superiority or Other||Difference in LS Means|-1.01|Standard Error of the Mean|0.3||0.0007|2-Sided|90.0|-1.5|-0.52||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686234|NCT01164579|3102069|Superiority or Other||Difference in LS Means|-0.67|Standard Error of the Mean|0.28||0.0196|2-Sided|90.0|-1.14|-0.2||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9|
1686235|NCT01164579|3102069|Superiority or Other||Difference in LS Means|-1.16|Standard Error of the Mean|0.28|<|0.0001|2-Sided|90.0|-1.63|-0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 9|
1686236|NCT01164579|3102069|Superiority or Other||Difference in LS Means|-1.03|Standard Error of the Mean|0.28|<|0.0002|2-Sided|90.0|-1.49|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686237|NCT01164579|3102069|Superiority or Other||Difference in LS Means|-1.02|Standard Error of the Mean|0.28|<|0.0003|2-Sided|90.0|-1.48|-0.57||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686238|NCT01164579|3102069|Superiority or Other||Difference in LS Means|-0.39|Standard Error of the Mean|0.27|<|0.1457|2-Sided|90.0|-0.84|0.05||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3|
1686239|NCT01164579|3102069|Superiority or Other||Difference in LS Means|-0.68|Standard Error of the Mean|0.27|<|0.0125|2-Sided|90.0|-1.13|-0.23||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3|
1686240|NCT01164579|3102069|Superiority or Other||Difference in LS Means|-0.64|Standard Error of the Mean|0.27|<|0.0175|2-Sided|90.0|-1.08|-0.2||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2|
1686241|NCT01164579|3102069|Superiority or Other||Difference in LS Means|-1.08|Standard Error of the Mean|0.27|<|0.0001|2-Sided|90.0|-1.52|-0.64||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 2|
1686242|NCT01164579|3102069|Superiority or Other||Difference in LS Means|-0.67|Standard Error of the Mean|0.26|<|0.0102|2-Sided|90.0|-1.1|-0.24||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1|
1686243|NCT01164579|3102069|Superiority or Other||Difference in LS Means|-0.88|Standard Error of the Mean|0.26|<|0.001|2-Sided|90.0|-1.31|-0.45||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1|
1686244|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|-0.9|||||2-Sided|90.0|-1.51|-0.29||||||Month 12|
1686245|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|-1.1|||||2-Sided|90.0|-1.69|-0.51||||||Month 12|
1686246|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|-0.73|||||2-Sided|90.0|-1.33|-0.13||||||Month 9|
1686247|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|-1.21|||||2-Sided|90.0|-1.81|-0.61||||||Month 9|
1686248|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|-1.18|||||2-Sided|90.0|-1.73|-0.63||||||Month 6|
1686249|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|-1.18|||||2-Sided|90.0|-1.75|-0.61||||||Month 6|
1686250|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|-0.41|||||2-Sided|90.0|-0.94|0.12||||||Month 3|
1686251|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|-0.81|||||2-Sided|90.0|-1.33|-0.29||||||Month 3|
1686252|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|-0.69|||||2-Sided|90.0|-1.2|-0.18||||||Month 2|
1686253|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|-1.21|||||2-Sided|90.0|-1.73|-0.7||||||Month 2|
1686254|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|-0.62|||||2-Sided|90.0|-1.01|-0.22||||||Month 1|
1686255|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|-0.94|||||2-Sided|90.0|-1.38|-0.5||||||Month 1|
1686256|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|0.12|||||2-Sided|90.0|-0.19|0.43||||||Baseline|
1686257|NCT01164579|3102070|Superiority or Other||Mean Difference (Final Values)|-0.22|||||2-Sided|90.0|-0.56|0.13||||||Baseline|
1686258|NCT01164579|3102071|Superiority or Other||Mean Difference (Final Values)|11.71|Standard Error of the Mean|10.36||0.2587|2-Sided|90.0|-5.34|28.76|||Normal approximation to the binomial|||Month 12|
1686259|NCT01164579|3102071|Superiority or Other||Mean Difference (Final Values)|1.23|Standard Error of the Mean|9.8||0.8997|2-Sided|90.0|-14.89|17.36|||Normal approximation to the binomial|||Month 12|
1686260|NCT01164579|3102071|Superiority or Other||Mean Difference (Final Values)|14.41|Standard Error of the Mean|10.15||0.1558|2-Sided|90.0|-2.29|31.12|||Normal approximation to the binomial|||Month 9|
1686261|NCT01164579|3102071|Superiority or Other||Mean Difference (Final Values)|12.5|Standard Error of the Mean|10.15||0.2177|2-Sided|90.0|-4.18|29.2|||Normal approximation to the binomial|||Month 9|
1686262|NCT01164579|3102071|Superiority or Other||Mean Difference (Final Values)|8.93|Standard Error of the Mean|10.23||0.3827|2-Sided|90.0|-7.9|25.76|||Normal approximation to the binomial|||Month 6|
1686263|NCT01164579|3102071|Superiority or Other||Mean Difference (Net)|12.66|Standard Error of the Mean|10.49||0.2276|2-Sided|90.0|-4.6|29.93|||Normal approximation to the binomial|||Month 6|
1686264|NCT01164579|3102071|Superiority or Other||Mean Difference (Final Values)|16.96|Standard Error of the Mean|9.04||0.0606|2-Sided|90.0|2.09|31.84|||Normal approximation to the binomial|||Month 3|
1686265|NCT01164579|3102071|Superiority or Other||Mean Difference (Final Values)|14.9|Standard Error of the Mean|8.97||0.0969|2-Sided|90.0|0.13|29.67|||Normal approximation to the binomial|||Month 3|
1686266|NCT01164579|3102071|Superiority or Other||Mean Difference (Final Values)|16.81|Standard Error of the Mean|7.86||0.0324|2-Sided|90.0|3.88|29.75|||Normal approximation to the binomial|||Month 2|
1686267|NCT01164579|3102071|Superiority or Other||Mean Difference (Final Values)|26.02|Standard Error of the Mean|8.68||0.0027|2-Sided|90.0|11.73|40.3|||Normal approximation to the binomial|||Month 2|
1686268|NCT01164579|3102071|Superiority or Other||Mean Difference (Final Values)|2.85|Standard Error of the Mean|2.81||0.3102|2-Sided|90.0|-1.77|7.48|||Normal approximation to the binomial|||Month 1|
1686269|NCT01164579|3102071|Superiority or Other||Mean Difference (Final Values)|8.57|Standard Error of the Mean|4.73||0.07|2-Sided|90.0|0.78|16.35|||Normal approximation to the binomial|||Month 1|
1686270|NCT01164579|3102072|Superiority or Other||Mean Difference (Final Values)|14.71|Standard Error of the Mean|11.18||0.1882|2-Sided|90.0|-3.68|33.11|||Normal approximation to the binomial|||Month 12|
1686271|NCT01164579|3102072|Superiority or Other||Mean Difference (Final Values)|27.41|Standard Error of the Mean|11.24||0.0147|2-Sided|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 12|
1686272|NCT01164579|3102072|Superiority or Other||Mean Difference (Final Values)|14.71|Standard Error of the Mean|11.18||0.1882|2-Sided|90.0|-3.68|33.11|||Normal approximation to the binomial|||Month 9|
1686273|NCT01164579|3102072|Superiority or Other||Mean Difference (Final Values)|27.41|Standard Error of the Mean|11.24||0.0147|2-Sided|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 9|
1686274|NCT01164579|3102072|Superiority or Other||Mean Difference (Final Values)|25.6|Standard Error of the Mean|10.72||0.0169|2-Sided|90.0|7.95|43.24|||Normal approximation to the binomial|||Month 6|
1686275|NCT01164579|3102072|Superiority or Other||Mean Difference (Final Values)|35.52|Standard Error of the Mean|10.75||0.0009|2-Sided|90.0|17.82|53.22|||Normal approximation to the binomial|||Month 6|
1686276|NCT01164579|3102072|Superiority or Other||Mean Difference (Final Values)|25.67|Standard Error of the Mean|10.91||0.0186|2-Sided|90.0|7.71|43.63|||Normal approximation to the binomial|||Month 3|
1686277|NCT01164579|3102072|Superiority or Other||Mean Difference (Final Values)|24.24|Standard Error of the Mean|11.0||0.0275|2-Sided|90.0|6.14|42.35|||Normal approximation to the binomial|||Month 3|
1686278|NCT01164579|3102072|Superiority or Other||Mean Difference (Final Values)|17.11|Standard Error of the Mean|9.92||0.0845|2-Sided|90.0|0.79|33.43|||Normal approximation to the binomial|||Month 2|
1686279|NCT01164579|3102072|Superiority or Other||Mean Difference (Final Values)|29.49|Standard Error of the Mean|10.37||0.0044|2-Sided|90.0|12.43|46.56|||Normal approximation to the binomial|||Month 2|
1686280|NCT01164579|3102072|Superiority or Other||Mean Difference (Final Values)|20.15|Standard Error of the Mean|7.58||0.0078|2-Sided|90.0|7.68|32.62|||Normal approximation to the binomial|||Month 1|
1686281|NCT01164579|3102072|Superiority or Other||Mean Difference (Final Values)|20.15|Standard Error of the Mean|7.58||0.0078|2-Sided|90.0|7.68|32.62|||Normal approximation to the binomial|||Month 1|
1686282|NCT01164579|3102073|Superiority or Other||Mean Difference (Final Values)|17.86|Standard Error of the Mean|11.5||0.1203|2-Sided|90.0|-1.05|36.79|||Normal approximation to the binomial|||Month 12|
1686283|NCT01164579|3102073|Superiority or Other||Mean Difference (Final Values)|28.18|Standard Error of the Mean|11.16||0.0115|2-Sided|90.0|9.81|46.55|||Normal approximation to the binomial|||Month 12|
1686284|NCT01164579|3102073|Superiority or Other||Mean Difference (Final Values)|15.09|Standard Error of the Mean|11.56||0.1921|2-Sided|90.0|-3.94|34.12|||Normal approximation to the binomial|||Month 9|
1686285|NCT01164579|3102073|Superiority or Other||Mean Difference (Final Values)|28.18|Standard Error of the Mean|11.16||0.0115|2-Sided|90.0|9.81|46.55|||Normal approximation to the binomial|||Month 9|
1686286|NCT01164579|3102073|Superiority or Other||Mean Difference (Final Values)|12.46|Standard Error of the Mean|11.55||0.2808|2-Sided|90.0|-6.54|31.47|||Normal approximation to the binomial|||Month 3|
1686287|NCT01164579|3102073|Superiority or Other||Mean Difference (Final Values)|28.49|Standard Error of the Mean|10.85||0.0086|2-Sided|90.0|10.63|46.35|||Normal approximation to the binomial|||Month 3|
1686288|NCT01164579|3102073|Superiority or Other||Mean Difference (Final Values)|20.57|Standard Error of the Mean|11.45||0.0724|2-Sided|90.0|1.73|39.41|||Normal approximation to the binomial|||Month 2|
1686289|NCT01164579|3102073|Superiority or Other||Mean Difference (Final Values)|28.03|Standard Error of the Mean|11.25||0.0127|2-Sided|90.0|9.51|46.54|||Normal approximation to the binomial|||Month 2|
1686290|NCT01164579|3102073|Superiority or Other||Mean Difference (Final Values)|27.41|Standard Error of the Mean|11.24||0.0147|2-Sided|90.0|8.91|45.9|||Normal approximation to the binomial|||Month 1|
1686291|NCT01164579|3102073|Superiority or Other||Mean Difference (Final Values)|13.12|Standard Error of the Mean|11.24||0.243|2-Sided|90.0|-5.36|31.62|||Normal approximation to the binomial|||Month 1|
1686292|NCT01164579|3102074|Superiority or Other||Difference in LS Means|-0.69|Standard Error of the Mean|0.37||0.062|2-Sided|90.0|-1.31|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686293|NCT01164579|3102074|Superiority or Other||Difference in LS Means|-0.23|Standard Error of the Mean|0.36||0.5369|2-Sided|90.0|-0.83|0.38||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686294|NCT01164579|3102074|Superiority or Other||Difference in LS Means|-0.67|Standard Error of the Mean|0.36||0.0631|2-Sided|90.0|-1.27|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686295|NCT01164579|3102074|Superiority or Other||Difference in LS Means|-0.42|Standard Error of the Mean|0.35||0.2351|2-Sided|90.0|-1.0|0.16||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686296|NCT01164579|3102075|Superiority or Other||Difference in LS Means|-0.69|Standard Error of the Mean|0.37||0.062|2-Sided|90.0|-1.31|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686297|NCT01164579|3102075|Superiority or Other||Difference in LS Means|-0.23|Standard Error of the Mean|0.36||0.5369|2-Sided|90.0|-0.83|0.38||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686298|NCT01164579|3102075|Superiority or Other||Difference in LS Means|-0.67|Standard Error of the Mean|0.36||0.0631|2-Sided|90.0|-1.27|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686299|NCT01164579|3102075|Superiority or Other||Difference in LS Means|-0.42|Standard Error of the Mean|0.35||0.2351|2-Sided|90.0|-1.0|0.16||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686300|NCT01164579|3102076|Superiority or Other||Difference in LS Means|-0.83|Standard Error of the Mean|0.52||0.1101|2-Sided|90.0|-1.69|0.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686301|NCT01164579|3102076|Superiority or Other||Difference in LS Means|-0.29|Standard Error of the Mean|0.51||0.5764|2-Sided|90.0|-1.13|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686302|NCT01164579|3102076|Superiority or Other||Difference in LS Means|-0.41|Standard Error of the Mean|0.5||0.4193|2-Sided|90.0|-1.25|0.43||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686303|NCT01164579|3102076|Superiority or Other||Difference in LS Means|-0.07|Standard Error of the Mean|0.5||0.8959|2-Sided|90.0|-0.89|0.76||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686304|NCT01164579|3102077|Superiority or Other||Difference in LS Means|-0.83|Standard Error of the Mean|0.52||0.1101|2-Sided|90.0|-1.69|0.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686305|NCT01164579|3102077|Superiority or Other||Difference in LS Means|-0.29|Standard Error of the Mean|0.51||0.5764|2-Sided|90.0|-1.13|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686306|NCT01164579|3102077|Superiority or Other||Difference in LS Means|-0.41|Standard Error of the Mean|0.5||0.4193|2-Sided|90.0|-1.25|0.43||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686307|NCT01164579|3102077|Superiority or Other||Difference in LS Means|-0.07|Standard Error of the Mean|0.5||0.8959|2-Sided|90.0|-0.89|0.76||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1688042|NCT01145898|3104748|Superiority or Other|||||||0.1822|||||||ANCOVA||||
1686308|NCT01164579|3102078|Superiority or Other||Difference in LS Means|-1.51|Standard Error of the Mean|0.75||0.0459|2-Sided|90.0|-2.76|-0.27||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686309|NCT01164579|3102078|Superiority or Other||Difference in LS Means|-0.51|Standard Error of the Mean|0.74||0.49|2-Sided|90.0|-1.74|0.72||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686310|NCT01164579|3102078|Superiority or Other||Difference in LS Means|-1.07|Standard Error of the Mean|0.73||0.1462|2-Sided|90.0|-2.28|0.14||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686311|NCT01164579|3102078|Superiority or Other||Difference in LS Means|-0.48|Standard Error of the Mean|0.72||0.5019|2-Sided|90.0|-1.68|0.71||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686312|NCT01164579|3102079|Superiority or Other||Difference in LS Means|-1.51|Standard Error of the Mean|0.75||0.0459|2-Sided|90.0|-2.76|-0.27|||mixed model repeated measures analysis|||Month 12|
1686313|NCT01164579|3102079|Superiority or Other||Difference in LS Means|-0.51|Standard Error of the Mean|0.74||0.49|2-Sided|90.0|-1.74|0.72||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686314|NCT01164579|3102079|Superiority or Other||Difference in LS Means|-1.07|Standard Error of the Mean|0.73||0.1462|2-Sided|90.0|-2.28|0.14||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686315|NCT01164579|3102079|Superiority or Other||Difference in LS Means|-0.48|Standard Error of the Mean|0.72||0.5019|2-Sided|90.0|-1.68|0.71||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686316|NCT01164579|3102080|Superiority or Other||Difference in LS Means|-1.26|Standard Error of the Mean|0.37||0.0008|2-Sided|90.0|-1.87|-0.65||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686317|NCT01164579|3102080|Superiority or Other||Difference in LS Means|-1.29|Standard Error of the Mean|0.37||0.0005|2-Sided|90.0|-1.9|-0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686318|NCT01164579|3102080|Superiority or Other||Difference in LS Means|-0.67|Standard Error of the Mean|0.35||0.0624|2-Sided|90.0|-1.25|-0.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686319|NCT01164579|3102080|Superiority or Other||Difference in LS Means|-0.71|Standard Error of the Mean|0.35||0.0463|2-Sided|90.0|-1.29|-0.12||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686320|NCT01164579|3102080|Superiority or Other||Difference in LS Means|-0.08|Standard Error of the Mean|0.35||0.8092|2-Sided|90.0|-0.66|0.49||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3|
1686321|NCT01164579|3102080|Superiority or Other||Difference in LS Means|-0.57|Standard Error of the Mean|0.35||0.1086|2-Sided|90.0|-1.15|0.01||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3|
1686322|NCT01164579|3102080|Superiority or Other||Difference in LS Means|0.0|Standard Error of the Mean|0.35||0.9935|2-Sided|90.0|-0.58|0.57||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1|
1686323|NCT01164579|3102080|Superiority or Other||Difference in LS Means|-0.39|Standard Error of the Mean|0.35||0.2689|2-Sided|90.0|-0.96|0.19||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1|
1686324|NCT01164579|3102081|Superiority or Other||Difference in LS Means|-2.29|Standard Error of the Mean|0.63||0.0003|2-Sided|90.0|-3.32|-1.25||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686325|NCT01164579|3102081|Superiority or Other||Difference in LS Means|-2.1|Standard Error of the Mean|0.62||0.0008|2-Sided|90.0|-3.13|-1.08||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686326|NCT01164579|3102081|Superiority or Other||Difference in LS Means|-1.32|Standard Error of the Mean|0.58||0.0231|2-Sided|90.0|-2.28|-0.37||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3|
1686327|NCT01164579|3102081|Superiority or Other||Difference in LS Means|-1.24|Standard Error of the Mean|0.59||0.0351|2-Sided|90.0|-2.21|-0.27||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 3|
1686328|NCT01164579|3102081|Superiority or Other||Difference in LS Means|0.08|Standard Error of the Mean|0.57||0.8817|2-Sided|90.0|-0.85|1.02||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1|
1686329|NCT01164579|3102081|Superiority or Other||Difference in LS Means|-0.4|Standard Error of the Mean|0.58||0.489|2-Sided|90.0|-1.36|0.56||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1|
1686330|NCT01164579|3102082|Superiority or Other||Difference in LS Means|-0.49|Standard Error of the Mean|0.63||0.435|2-Sided|90.0|-1.53|0.55||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686331|NCT01164579|3102082|Superiority or Other||Difference in LS Means|-1.6|Standard Error of the Mean|0.62||0.0103|2-Sided|90.0|-2.62|-0.58||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 12|
1686332|NCT01164579|3102082|Superiority or Other||Difference in LS Means|-1.01|Standard Error of the Mean|0.59||0.0868|2-Sided|90.0|-1.98|-0.04||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686333|NCT01164579|3102082|Superiority or Other||Difference in LS Means|-0.94|Standard Error of the Mean|0.58||0.1038|2-Sided|90.0|-1.89|0.01||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 6|
1686334|NCT01164579|3102082|Superiority or Other||Difference in LS Means|-0.17|Standard Error of the Mean|0.55||0.7565|2-Sided|90.0|-1.09|0.74||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1|
1686335|NCT01164579|3102082|Superiority or Other||Difference in LS Means|-0.25|Standard Error of the Mean|0.57||0.6576|2-Sided|90.0|-1.19|0.69||2-sided p-value; alpha=0.10|mixed model repeated measures analysis|||Month 1|
1686336|NCT01164579|3102083|Superiority or Other||Difference in LS Means|-1.74|Standard Error of the Mean|0.59||0.0038|2-Sided|90.0|-2.72|-0.76||2-sided p-value; alpha= 0.10|mixed model repeated measures analysis||||
1686337|NCT01164579|3102083|Superiority or Other||Difference in LS Means|-1.55|Standard Error of the Mean|0.59||0.0089|2-Sided|90.0|-2.52|-0.58||2-sided p-value; alpha= 0.10|mixed model repeated measures analysis||||
1686338|NCT01164579|3102084|Superiority or Other||Difference in LS Mean|-0.52|Standard Error of the Mean|0.57||0.3561|2-Sided|90.0|-1.46|0.41||2-sided p-value; alpha=0.10|mixed model repeated measures analysis||||
1686339|NCT01164579|3102084|Superiority or Other||Difference in least squares (LS) Mean|-0.63|Standard Error of the Mean|0.57||0.2696|2-Sided|90.0|-1.58|0.31||2-sided p-value; alpha equals (=) 0.10|mixed model repeated measures analysis||||
1686340|NCT01164501|3102086|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|-0.56|-0.28||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in moderate renal impaired patients was the fourth step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 25mg minus placebo||
1686341|NCT01164501|3102087|Superiority or Other||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.88|-0.49||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 10 mg versus placebo in mild renal impaired patients was the third step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 25mg minus placebo||
1686342|NCT01164501|3102087|Superiority or Other||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.72|-0.32||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild renal impaired patients was the second step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication and baseline HbA1c.|Difference calculated as empa 10mg minus placebo||
1686343|NCT01164501|3102088|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.62|-0.39||Hierarchical testing to adjust for multiple comparisons, no adjustment in p-values. Empa 25 mg versus placebo in mild or moderate renal impaired patients was the first step in the hierarchical sequence.|ANCOVA|Based on ANCOVA with terms for treatment, background antidiabetic medication, renal impairment and baseline HbA1c.|Difference calculated as empa 25mg minus placebo||
1686344|NCT01164475|3102098|Superiority or Other||Odds Ratio (OR)|1.91||||0.395|2-Sided|95.0|0.44|9.17|||Regression, Logistic|||The comparison was done using the logistic regression model, adjusted for country and baseline PB CD34+ cell count.|
1686345|NCT01164137|3102099|Superiority or Other||Mean Difference (Final Values)|1.85||||0.13|2-Sided|95.0|-0.56|4.27|||t-test, 2 sided||||
1686346|NCT01164137|3102100|Superiority or Other||Mean Difference (Final Values)|1.71||||0.11|2-Sided|95.0|-0.39|3.81|||t-test, 2 sided||||
1686347|NCT01164137|3102101|Superiority or Other||Mean Difference (Final Values)|1.21||||0.18|2-Sided|95.0|-0.57|3.01|||t-test, 2 sided||||
1686348|NCT01164137|3102102|Superiority or Other||Mean Difference (Final Values)|0.63||||0.32|2-Sided|95.0|-0.62|1.88|||t-test, 2 sided||||
1686349|NCT01164137|3102103|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.87|2-Sided|95.0|-0.98|0.84|||t-test, 2 sided||||
1686350|NCT01164098|3102104|Superiority|||||||0.37|||||||t-test, 2 sided|||T-test|
1686351|NCT01164098|3102105|Superiority|||||||0.49|||||||t-test, 2 sided|||T-test of Natural Log Transformed Data.|
1686352|NCT01164098|3102106|Superiority|||||||0.18|||||||t-test, 2 sided|Using Natural Log Transformed Data||T-test of the natural logarithmic transformed data|
1686353|NCT01164007|3102117|Superiority or Other|||||||0.071|||||||One-sample exact binomial test|||The observed percentage of participants with CR or PR was compared with the expected proportion under the null hypothesis (0.10) and analyzed for statistical significance using a one-sample exact binomial test.|
1686354|NCT01163955|3102118|Superiority or Other||Mean Difference (Final Values)|1.7|Standard Deviation|1.99|<|0.0005|2-Sided|95.0|0.0|9.0|||t-test, 2 sided|DF=50||Start total score at 0 minutes is being compared to the end total score at 5 minutes while sitting in a chair.|
1686355|NCT01163955|3102118|Superiority or Other||Mean Difference (Final Values)|1.8|Standard Deviation|1.92|<|0.0005|2-Sided|95.0|0.0|9.0|||t-test, 2 sided|DF=50||Start total score at 0 minutes is being compared to the end total score at 5 minutes while sitting in the floor.|
1686356|NCT01163721|3102179|Superiority or Other||difference in least squares mean (LSM)|-2.5|Standard Error of the Mean|9.38||0.794|2-Sided|95.0|-21.1|16.2||P-value is from an ANCOVA model with treatment and baseline HbA1c stratification as factors and baseline value as covariate.|ANCOVA||||
1686357|NCT01163721|3102180|Superiority or Other||difference in LSM|-15.4|Standard Error of the Mean|12.83||0.234|2-Sided|95.0|-41.0|10.2||P-value is from an ANCOVA model with treatment and baseline HbA1c stratification as factors and baseline value as covariate.|ANCOVA||||
1686358|NCT01163721|3102181|Superiority or Other||difference in least squares mean (LSM)|-0.53|Standard Error of the Mean|0.2||0.01|2-Sided|95.0|-0.93|-0.13||P-value is from an Analysis of Covariance (ANCOVA) model with treatment as factor and baseline HbA1c value as covariate. Due to the exploratory nature of this study, there were no adjustments for multiplicity.|ANCOVA|||Assuming a common standard deviation of 1.1%, 60 evaluable participants would provide 93% power to detect a statistically significant –1.0% difference in change from baseline HbA1c at Week 12 between ranolazine and placebo (2-sided alpha = 0.05). 80 participants were randomized to ensure at least 60 evaluable participants.|
1686359|NCT01163292|3102200|Superiority or Other|||||||0.609|||||||Wilcoxon Rank Sum|||Week 52|
1686360|NCT01163292|3102200|Superiority or Other|||||||0.44|||||||Wilcoxon Rank Sum|||Week 26|
1686361|NCT01163292|3102200|Superiority or Other|||||||0.266|||||||Wilcoxon Rank Sum|||Week 0|
1686362|NCT01163292|3102201|Superiority or Other|||||||0.335|||||||Wilcoxon Rank Sum||||
1686363|NCT01163292|3102202|Superiority or Other|||||||0.001|||||||Fisher Exact|||Week 52|
1686364|NCT01163292|3102202|Superiority or Other|||||||1|||||||Fisher Exact|||Week 26|
1686365|NCT01163292|3102202|Superiority or Other|||||||0.29|||||||Fisher Exact|||Week 0|
1686366|NCT01163292|3102203|Superiority or Other|||||||0.006|||||||Wilcoxon Rank Sum|||Week 52|
1686367|NCT01163292|3102203|Superiority or Other|||||||0.004|||||||Wilcoxon Rank Sum|||Week 26|
1686368|NCT01163292|3102203|Superiority or Other|||||||0.144|||||||Wilcoxon Rank Sum|||Week 0|
1686369|NCT01163279|3102204|Superiority or Other||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA||||
1686370|NCT01163279|3102205|Superiority or Other||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA||||
1686371|NCT01163279|3102205|Superiority or Other||||||>|0.05||||||Statistical analysis applies to immediately post intervention category|ANOVA||||
1686372|NCT01163279|3102206|Superiority or Other||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA||||
1686373|NCT01163279|3102207|Superiority or Other||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA||||
1686374|NCT01163279|3102207|Superiority or Other||||||<|0.1||||||Statistical analysis applies to immediately post intervention category|ANOVA||||
1686375|NCT01163279|3102208|Superiority or Other||||||>|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA||||
1686376|NCT01163279|3102208|Superiority or Other||||||<|0.05||||||Statistical analysis applies to immediately post intervention category|ANOVA||||
1686377|NCT01163279|3102209|Superiority or Other||||||<|0.05||||||Statistical analysis applies to 3 months post intervention category|ANOVA||||
1686378|NCT01163279|3102209|Superiority or Other||||||<|0.1||||||Statistical analysis applies to immediately post intervention category|ANOVA||||
1686379|NCT01163279|3102210|Superiority or Other||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA||||
1686380|NCT01163279|3102211|Superiority or Other||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA||||
1686381|NCT01163279|3102212|Superiority or Other||||||>|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA||||
1686382|NCT01163279|3102213|Superiority or Other||||||<|0.05||||||Statistical analysis applies to immediately post intervention and 3 months post intervention categories|ANOVA||||
1686383|NCT01163279|3102214|Superiority or Other|||||||0.26||||||Statistical analysis applies to 3-month follow up satisfaction category|Chi-squared||||
1686384|NCT01163279|3102214|Superiority or Other|||||||0.54||||||Statistical analysis applies to 3-month follow up performance category|Chi-squared||||
1686385|NCT01163279|3102214|Superiority or Other|||||||0.32||||||Statistical analysis applies to post intervention satisfaction category|Chi-squared||||
1686386|NCT01163279|3102214|Superiority or Other|||||||0.03||||||Statistical analysis applies to post intervention performance category|Chi-squared||||
1686387|NCT01163266|3102215|Superiority or Other||LS Mean Difference|-2.4|Standard Error of the Mean|1.066||0.025|2-Sided|95.0|-4.5|-0.3|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.|||
1686388|NCT01163266|3102215|Superiority or Other||LS Mean Difference|-1.39|Standard Error of the Mean|1.042||0.183|2-Sided|95.0|-3.44|0.66|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.|||
1686389|NCT01163266|3102216|Superiority or Other||Odds Ratio (OR)|1.779||||0.059|2-Sided|95.0|0.979|3.233|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1686390|NCT01163266|3102216|Superiority or Other||Odds Ratio (OR)|1.665||||0.093|2-Sided|95.0|0.918|3.018|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1686391|NCT01163266|3102217|Superiority or Other||LS Mean Difference|-7.26|Standard Error of the Mean|1.852|<|0.001|2-Sided|95.0|-10.92|-3.6|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.|||
1686392|NCT01163266|3102217|Superiority or Other||LS Mean Difference|-4.29|Standard Error of the Mean|1.891|<|0.025|2-Sided|95.0|-8.03|-0.56|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS Total score-by-week as fixed effects.|||
1686393|NCT01163266|3102218|Superiority or Other||LS Mean Difference|-0.29|Standard Error of the Mean|0.129||0.024|2-Sided|95.0|-0.55|-0.04|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.|||
1686394|NCT01163266|3102218|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.129||0.119|2-Sided|95.0|-0.45|0.05|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.|||
1686395|NCT01163266|3102219|Superiority or Other||Odds Ratio (OR)|1.639||||0.044|2-Sided|95.0|1.013|2.652||Pre-specified sequential statistical testing procedure indicates that when p-value >0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1686396|NCT01163266|3102219|Superiority or Other||Odds Ratio (OR)|1.29||||0.301|2-Sided|95.0|0.796|2.093|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1686397|NCT01163266|3102220|Superiority or Other||LS Mean Difference|-3.64|Standard Error of the Mean|1.161||0.002|2-Sided|95.0|-5.92|-1.35||Pre-specified sequential statistical testing procedure indicates that when p-value <0.025, hierarchical testing continues.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.|||
1686398|NCT01163266|3102220|Superiority or Other||LS Mean Difference|-2.19|Standard Error of the Mean|1.151||0.058|2-Sided|95.0|-4.45|0.08||Pre-specified sequential statistical testing procedure indicates that when p-value >0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.|
1686399|NCT01163214|3102299|Superiority or Other|||||||0.009|||||||t-test, 2 sided|||Comparison between arms for femoral, peroneal, or tibial nerves.|
1686400|NCT01163214|3102299|Superiority or Other|||||||0.62|||||||t-test, 2 sided|||Comparison between arms for tibial nerve.|
1686401|NCT01163214|3102299|Superiority or Other|||||||0.01|||||||t-test, 2 sided|||Comparison between arms for common peroneal nerve.|
1686402|NCT01163214|3102299|Superiority or Other|||||||0.49|||||||t-test, 2 sided|||Comparison between arms for femoral nerve.|
1686403|NCT01163214|3102300|Superiority or Other|||||||0.02|||||||t-test, 2 sided|||Comparison between the arms for length of stay in the hospital.|
1686404|NCT01163214|3102301|Superiority or Other|||||||0.97|||||||t-test, 2 sided|||Comparison between arms for postoperative day 2 afternoon.|
1686405|NCT01163214|3102301|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||Comparison between arms for postoperative day 2 morning.|
1686406|NCT01163214|3102301|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Comparison between arms for postoperative day 1 afternoon.|
1686407|NCT01163214|3102301|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Comparison between arms for postoperative day 1 morning.|
1686408|NCT01163214|3102302|Superiority or Other|||||||0.51|||||||t-test, 2 sided|||Comparison of arms for narcotic use on post operative day 2 as needed.|
1686409|NCT01163214|3102302|Superiority or Other|||||||0.17|||||||t-test, 2 sided|||Comparison of arms for narcotic use on post operative day 1 as needed.|
1686410|NCT01163214|3102302|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Comparison of arms for narcotic use on day of surgery as needed.|
1686411|NCT01163214|3102302|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Comparison of arms for intraoperative narcotic use.|
1686412|NCT01163214|3102303|Superiority or Other|||||||0.59|||||||Wilcoxon (Mann-Whitney)||||
1686413|NCT01163214|3102303|Superiority or Other|||||||0.76|||||||t-test, 2 sided||||
1686414|NCT01163214|3102304|Superiority or Other|||||||0.58|||||||Wilcoxon (Mann-Whitney)||||
1686415|NCT01163214|3102304|Superiority or Other|||||||0.78|||||||t-test, 2 sided||||
1686416|NCT01163149|3102311|Superiority||Hodges-Lehmann-Sen|44.0||||0.1303|2-Sided|95.0|-73.0|114.0||Two-sided with p-value threshold <0.05 for statistical significance|Wilcoxon rank-sum||Estimate and exact confidence interval are from Hodges-Lehmann-Sen method for location shift in distribution between the treatment group and the control group|Week 24 Change from Baseline|
1686417|NCT01163149|3102312|Superiority||Hodges-Lehmann-Sen|-0.0315||||0.1222|2-Sided|95.0|-0.059|0.012||Two-sided with p-value threshold <0.05 for statistical significance|Wilcoxon rank-sum|||Whole Body BMD Change from Baseline to Week 24|
1686418|NCT01163149|3102312|Superiority||Hodges-Lehmann-Sen|0.0255||||0.2439|2-Sided|95.0|-0.009|0.041||Two-sided with p-value threshold <0.05 for statistical significance|Wilcoxon rank-sum|||Lumbar Spine BMD Change from Baseline to Week 24|
1686419|NCT01163149|3102312|Superiority||Hodges-Lehmann-Sen|-0.0125||||0.7357|2-Sided|95.0|-0.04|0.039||Two-sided with p-value threshold <0.05 for statistical significance|Wilcoxon rank-sum|||Hip Total Change from Baseline to Week 24|
1686420|NCT01163149|3102313|Superiority||Hodges-Lehmann-Sen|-77.1||||0.0485|2-Sided|95.0|-917.44|-1.74||Two-sided with p-value threshold <0.05 for statistical significance|Wilcoxon rank-sum|||Whole Body BMC Change from Baseline to Week 24|
1686421|NCT01163149|3102313|Superiority||Hodges-Lehmann-Sen|1.33||||0.3827|2-Sided|95.0|-1.36|3.12||Two-sided with p-value threshold <0.05 for statistical significance|Wilcoxon rank-sum|||Lumbar Spine BMC Change from Baseline to Week 24|
1686422|NCT01163149|3102313|Superiority||Hodges-Lehmann-Sen|-0.91||||0.3301|2-Sided|95.0|-3.32|1.78||Two-sided with p-value threshold <0.05 for statistical significance|Wilcoxon rank-sum|||Hip Total BMC Change from Baseline to Week 24|
1686423|NCT01163149|3102315|Superiority|If p-values were less than 0.05 and the Hodges-Lehman-Sen estimate favored asfotase alfa (eg, it had a negative sign indicating the between-group differences in change from Baseline favored treated patients), then superiority over control was claimed.|Hodges-Lehman-Sen|-1.825||||0.0715|2-Sided|95.0|-3.21|0.23||Two-sided with p-value threshold <0.05 for statistical significance|Wilcoxon rank-sum||Estimate and exact confidence interval are from Hodges-Lehmann-Sen method for location shift in distribution between the treatment group and the control group.|PPi Change from Baseline to Week 24|
1686424|NCT01163149|3102316|Superiority|If p-values were less than 0.05 and the Hodges-Lehman-Sen estimate favored asfotase alfa (eg, it had a negative sign indicating the between-group differences in change from Baseline favored treated patients), then superiority over control was claimed.|Hodges-Lehman-Sen|-302.05||||0.0285|2-Sided|95.0|-626.4|-59.2||Two-sided with p-value threshold <0.05 for statistical significance|Wilcoxon rank-sum|||PLP Change from Baseline to Week 24|
1686425|NCT01163097|3102326|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1686426|NCT01163097|3102327|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1686427|NCT01163097|3102328|Superiority or Other|||||||0.9944|||||||ANOVA||||
1686428|NCT01163097|3102329|Superiority or Other|||||||0.4123|||||||ANOVA||||
1686429|NCT01163097|3102330|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1686430|NCT01163097|3102331|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1686431|NCT01163097|3102332|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1686432|NCT01163097|3102333|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1686433|NCT01163097|3102334|Superiority or Other||Geometric mean|0.972|||||2-Sided|95.0|0.768|1.231||||||80% power achieved for detecting a 140% increase with 13 and 6 subjects (respectively) when Treatment B was compared to Treatment C; assuming that the coefficient of variation of the protein/creatinine ratio would be 67% (Ginsberg et al 1983)|
1686434|NCT01163097|3102335|Superiority or Other||Geometric mean|0.373|||||2-Sided|95.0|0.216|0.645||||||80% power achieved for detecting a 70% increase (or 41% reduction) when Treatment A was compared to Treatment B; assuming that the coefficient of variation of lipase would be 49% (as observed in other study)|
1686435|NCT01163097|3102336|Superiority or Other||Geometric mean|0.737|||||2-Sided|95.0|0.614|0.885||||||80% power achieved for detecting a 20% increase (or 17% reduction) when Treatment A was compared to Treatment B; assuming that the coefficient of variation of amylase would be 14% (as observed in other study)|
1686458|NCT01162421|3102387|Superiority or Other||LS Mean Difference|-0.03|Standard Error of the Mean|0.062||0.579|2-Sided|95.0|-0.16|0.09||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9|
1686459|NCT01162421|3102387|Superiority or Other||LS Mean Difference|0.05|Standard Error of the Mean|0.062||0.447|2-Sided|95.0|-0.08|0.17||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6|
1686699|NCT01160380|3102669|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm-HADS anxiety|
1686436|NCT01163097|3102338|Non-Inferiority or Equivalence|The equivalence of the treatments was assessed using the 90% confidence interval (CI) of the geometric mean ratio for Ki67. The lower bound of the CI needed to be greater than 0.70 and the upper bound needed to be below 1.43 for the treatments to be considered equivalent.|Geometric mean ratio|0.863|||||2-Sided|90.0|0.759|0.982||||||H0: mean ratio<0.7 or mean ratio>1.43; H1: 0.7< mean ratio <1.43 Sample size calculation assumed change in Ki67 expression following palifermin administration would not be affected by co-administration of heparin. With n=26 (13 + 13), an approx. 80% probability that the 90% CI of the ratio of geometric means of Ki67 for palifermin when co-administered with heparin compared to palifermin alone would fall in the interval (0.7, 1.43). This assumed a Coefficient of Variation (CV) for Ki67 of 31%.|
1686437|NCT01162421|3102384|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|0.22||0.476|2-Sided|95.0|-0.3|0.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24|
1686438|NCT01162421|3102384|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.23||0.86|2-Sided|95.0|-0.4|0.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18|
1686439|NCT01162421|3102384|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.22||0.227|2-Sided|95.0|-0.2|0.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12|
1686440|NCT01162421|3102384|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.24||0.204|2-Sided|95.0|-0.2|0.8||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9|
1686441|NCT01162421|3102384|Superiority or Other||LS Mean Difference|0.8|Standard Error of the Mean|0.27||0.003|2-Sided|95.0|0.3|1.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 6|
1686442|NCT01162421|3102384|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|0.28||0.046|2-Sided|95.0|0.0|1.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3|
1686443|NCT01162421|3102385|Superiority or Other||LS Mean Difference|1.4|Standard Error of the Mean|1.58||0.38|2-Sided|95.0|-1.8|4.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24|
1686444|NCT01162421|3102385|Superiority or Other||LS Mean Difference|1.4|Standard Error of the Mean|1.67||0.42|2-Sided|95.0|-2.0|4.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18|
1686445|NCT01162421|3102385|Superiority or Other||LS Mean Difference|1.6|Standard Error of the Mean|1.69||0.357|2-Sided|95.0|-1.8|5.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12|
1686446|NCT01162421|3102385|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|1.42||0.692|2-Sided|95.0|-2.3|3.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9|
1686447|NCT01162421|3102385|Superiority or Other||LS Mean Difference|-1.4|Standard Error of the Mean|1.76||0.419|2-Sided|95.0|-4.9|2.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6|
1686448|NCT01162421|3102385|Superiority or Other||LS Mean Difference|1.2|Standard Error of the Mean|1.57||0.458|2-Sided|95.0|-2.0|4.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3|
1686449|NCT01162421|3102386|Superiority or Other||LS Mean Difference|-2.4|Standard Error of the Mean|5.72||0.675|2-Sided|95.0|-13.8|9.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24|
1686450|NCT01162421|3102386|Superiority or Other||LS Mean Difference|-1.1|Standard Error of the Mean|5.03||0.826|2-Sided|95.0|-11.1|8.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18|
1686451|NCT01162421|3102386|Superiority or Other||LS Mean Difference|-2.7|Standard Error of the Mean|4.8||0.579|2-Sided|95.0|-12.3|6.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12|
1686452|NCT01162421|3102386|Superiority or Other||LS Mean Difference|-2.4|Standard Error of the Mean|5.26||0.649|2-Sided|95.0|-12.9|8.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9|
1686453|NCT01162421|3102386|Superiority or Other||LS Mean Difference|7.9|Standard Error of the Mean|5.15||0.13|2-Sided|95.0|-2.4|18.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6|
1686454|NCT01162421|3102386|Superiority or Other||LS Mean Difference|-2.5|Standard Error of the Mean|4.42||0.572|2-Sided|95.0|-11.3|6.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3|
1686455|NCT01162421|3102387|Superiority or Other||LS Mean Difference|-0.04|Standard Error of the Mean|0.07||0.611|2-Sided|95.0|-0.17|0.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24|
1686456|NCT01162421|3102387|Superiority or Other||LS Mean Difference|-0.01|Standard Error of the Mean|0.064||0.894|2-Sided|95.0|-0.14|0.12||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18|
1686457|NCT01162421|3102387|Superiority or Other||LS Mean Difference|0.01|Standard Error of the Mean|0.057||0.922|2-Sided|95.0|-0.11|0.12||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12|
1688043|NCT01145898|3104749|Superiority or Other|||||||0.6081|||||||ANCOVA||||
1686460|NCT01162421|3102387|Superiority or Other||LS Mean Difference|0.01|Standard Error of the Mean|0.058||0.809|2-Sided|95.0|-0.1|0.13||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3|
1686461|NCT01162421|3102388|Superiority or Other||LS Mean Difference|1.1|Standard Error of the Mean|6.16||0.865|2-Sided|95.0|-11.3|13.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24|
1686462|NCT01162421|3102388|Superiority or Other||LS Mean Difference|2.7|Standard Error of the Mean|6.4||0.669|2-Sided|95.0|-10.1|15.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18|
1686463|NCT01162421|3102388|Superiority or Other||LS Mean Difference|3.4|Standard Error of the Mean|5.75||0.558|2-Sided|95.0|-8.2|15.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12|
1686464|NCT01162421|3102388|Superiority or Other||LS Mean Difference|-3.4|Standard Error of the Mean|6.31||0.598|2-Sided|95.0|-16.1|9.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9|
1686465|NCT01162421|3102388|Superiority or Other||LS Mean Difference|-7.9|Standard Error of the Mean|5.88||0.187|2-Sided|95.0|-19.7|4.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6|
1686466|NCT01162421|3102388|Superiority or Other||LS Mean Difference|-4.4|Standard Error of the Mean|5.86||0.453|2-Sided|95.0|-16.3|7.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3|
1686467|NCT01162421|3102389|Superiority or Other||Difference in percentage|-6.2||||0.418|2-Sided|95.0|-21.18|7.69|||Fisher Exact|Two-sided Fisher Exact test.||Month 24|
1686468|NCT01162421|3102389|Superiority or Other||Difference in percentage|7.2||||0.482|2-Sided|95.0|-8.92|22.89|||Fisher Exact|Two-sided Fisher Exact test.||Month 18|
1686469|NCT01162421|3102389|Superiority or Other||Difference in percentage|4.6||||0.712|2-Sided|95.0|-11.08|19.83|||Fisher Exact|Two-sided Fisher Exact test.||Month 12|
1686470|NCT01162421|3102389|Superiority or Other||Difference in percentage|-11.9||||0.142|2-Sided|95.0|-27.88|3.16|||Fisher Exact|Two-sided Fisher Exact test.||Month 9|
1686471|NCT01162421|3102389|Superiority or Other||Difference in percentage|-6.4||||0.468|2-Sided|95.0|-22.34|8.81|||Fisher Exact|Two-sided Fisher Exact test.||Month 6|
1686472|NCT01162421|3102389|Superiority or Other||Difference in percentage|-1.1||||1|2-Sided|95.0|-17.94|15.16|||Fisher Exact|Two-sided Fisher Exact test.||Month 3|
1686473|NCT01162421|3102390|Superiority or Other||LS Mean Difference|-1.1|Standard Error of the Mean|2.78||0.703|2-Sided|95.0|-6.6|4.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24|
1686474|NCT01162421|3102390|Superiority or Other||LS Mean Difference|-2.0|Standard Error of the Mean|2.75||0.461|2-Sided|95.0|-7.5|3.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18|
1686475|NCT01162421|3102390|Superiority or Other||LS Mean Difference|-2.7|Standard Error of the Mean|2.5||0.283|2-Sided|95.0|-7.7|2.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12|
1686476|NCT01162421|3102390|Superiority or Other||LS Mean Difference|-1.5|Standard Error of the Mean|2.36||0.514|2-Sided|95.0|-6.2|3.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9|
1686477|NCT01162421|3102390|Superiority or Other||LS Mean Difference|2.8|Standard Error of the Mean|2.45||0.261|2-Sided|95.0|-2.1|7.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6|
1686478|NCT01162421|3102390|Superiority or Other||LS Mean Difference|0.9|Standard Error of the Mean|2.25||0.699|2-Sided|95.0|-3.6|5.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3|
1686479|NCT01162421|3102391|Superiority or Other||Difference in percentage|2.2||||0.836|2-Sided|95.0|-18.63|23.03|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24|
1686480|NCT01162421|3102391|Superiority or Other||Difference in percentage|2.2||||0.836|2-Sided|95.0|-18.63|23.03|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18|
1686481|NCT01162421|3102391|Superiority or Other||Difference in percentage|-1.0||||0.931|2-Sided|95.0|-22.54|20.64|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12|
1686482|NCT01162421|3102391|Superiority or Other||Difference in percentage|1.6||||0.885|2-Sided|95.0|-20.16|23.38|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9|
1686483|NCT01162421|3102391|Superiority or Other||Difference in percentage|7.9||||0.444|2-Sided|95.0|-12.17|28.0|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6|
1686484|NCT01162421|3102391|Superiority or Other||Difference in percentage|-10.9||||0.283|2-Sided|95.0|-30.84|9.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3|
1686485|NCT01162421|3102392|Superiority or Other||Difference in percentage|-16.1||||0.166|2-Sided|95.0|-38.64|6.4|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24|
1686486|NCT01162421|3102392|Superiority or Other||Difference in percentage|-3.3||||0.776|2-Sided|95.0|-25.96|19.37|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18|
1686487|NCT01162421|3102392|Superiority or Other||Difference in percentage|-9.6||||0.392|2-Sided|95.0|-31.39|12.19|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12|
1686488|NCT01162421|3102392|Superiority or Other||Difference in percentage|7.0||||0.54|2-Sided|95.0|-15.3|29.22|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9|
1686700|NCT01160380|3102669|Superiority or Other|||||||0.005|||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression|
1686489|NCT01162421|3102392|Superiority or Other||Difference in percentage|-3.0||||0.796|2-Sided|95.0|-25.77|19.77|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6|
1686490|NCT01162421|3102392|Superiority or Other||Difference in percentage|-11.9||||0.299|2-Sided|95.0|-34.05|10.31|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3|
1686491|NCT01162421|3102393|Superiority or Other||LS Mean Difference|0.08|Standard Error of the Mean|0.148||0.572|2-Sided|95.0|-0.21|0.38||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24|
1686492|NCT01162421|3102393|Superiority or Other||LS Mean Difference|0.05|Standard Error of the Mean|0.141||0.738|2-Sided|95.0|-0.23|0.33||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18|
1686493|NCT01162421|3102393|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.129||0.452|2-Sided|95.0|-0.16|0.35||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12|
1686494|NCT01162421|3102393|Superiority or Other||LS Mean Difference|0.02|Standard Error of the Mean|0.132||0.863|2-Sided|95.0|-0.24|0.29||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9|
1686495|NCT01162421|3102393|Superiority or Other||LS Mean Difference|-0.17|Standard Error of the Mean|0.132||0.194|2-Sided|95.0|-0.44|0.09||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6|
1686496|NCT01162421|3102393|Superiority or Other||LS Mean Difference|0.03|Standard Error of the Mean|0.13||0.809|2-Sided|95.0|-0.23|0.29||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3|
1686497|NCT01162421|3102394|Superiority or Other||Difference in percentage|6.8||||0.486|2-Sided|95.0|-9.21|22.22|||Fisher Exact|Two-sided Fisher Exact test.|||
1686498|NCT01162421|3102395|Superiority or Other||Difference in percentage|-4.0||||0.727|2-Sided|95.0|-20.34|11.52|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24|
1686499|NCT01162421|3102395|Superiority or Other||Difference in percentage|-12.6||||0.142|2-Sided|95.0|-29.46|4.26|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18|
1686500|NCT01162421|3102395|Superiority or Other||Difference in percentage|-14.1||||0.186|2-Sided|95.0|-34.83|6.7|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12|
1686501|NCT01162421|3102395|Superiority or Other||Difference in percentage|-0.4||||0.972|2-Sided|95.0|-20.94|20.21|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9|
1686502|NCT01162421|3102395|Superiority or Other||Difference in percentage|5.1||||0.63|2-Sided|95.0|-15.43|25.54|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6|
1686503|NCT01162421|3102395|Superiority or Other||Difference in percentage|11.6||||0.316|2-Sided|95.0|-10.84|33.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3|
1686504|NCT01162421|3102396|Superiority or Other||Difference in percentage|-10.7||||0.358|2-Sided|95.0|-33.38|11.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24|
1686505|NCT01162421|3102396|Superiority or Other||Difference in percentage|-2.7||||0.816|2-Sided|95.0|-25.52|20.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18|
1686506|NCT01162421|3102396|Superiority or Other||Difference in percentage|8.1||||0.485|2-Sided|95.0|-14.61|30.87|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12|
1686507|NCT01162421|3102396|Superiority or Other||Difference in percentage|2.7||||0.816|2-Sided|95.0|-20.1|25.52|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9|
1686508|NCT01162421|3102396|Superiority or Other||Difference in percentage|20.1||||0.076|2-Sided|95.0|-1.53|41.83|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6|
1686509|NCT01162421|3102396|Superiority or Other||Difference in percentage|7.9||||0.444|2-Sided|95.0|-12.17|28.0|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3|
1686510|NCT01162421|3102397|Superiority or Other||Difference in percentage|-10.7||||0.358|2-Sided|95.0|-33.38|11.99|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24|
1686511|NCT01162421|3102397|Superiority or Other||Difference in percentage|-2.7||||0.816|2-Sided|95.0|-25.52|20.1|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18|
1686512|NCT01162421|3102397|Superiority or Other||Difference in percentage|7.8||||0.5|2-Sided|95.0|-14.88|30.56|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12|
1686513|NCT01162421|3102397|Superiority or Other||Difference in percentage|5.0||||0.668|2-Sided|95.0|-17.74|27.71|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9|
1686514|NCT01162421|3102397|Superiority or Other||Difference in percentage|22.7||||0.047|2-Sided|95.0|1.03|44.39|||Chi-squared|P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.||Month 6|
1686515|NCT01162421|3102397|Superiority or Other||Difference in percentage|10.5||||0.318|2-Sided|95.0|-9.83|30.78|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3|
1686516|NCT01162421|3102398|Superiority or Other||Difference in percentage|-4.4||||0.701|2-Sided|95.0|-26.8|18.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24|
1686517|NCT01162421|3102398|Superiority or Other||Difference in percentage|-3.5||||0.747|2-Sided|95.0|-24.9|17.86|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18|
1686518|NCT01162421|3102398|Superiority or Other||Difference in percentage|13.0||||0.22|2-Sided|95.0|-7.46|33.54|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12|
1686519|NCT01162421|3102398|Superiority or Other||Difference in percentage|-3.2||||0.762|2-Sided|95.0|-24.1|17.66|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9|
1686591|NCT01162421|3102410|Superiority or Other||Difference in percentage|6.7||||0.552|2-Sided|95.0|-15.29|28.63|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9|
1686520|NCT01162421|3102398|Superiority or Other||Difference in percentage|24.5||||0.014|2-Sided|95.0|6.09|42.85|||Chi-squared|P-value is based on two-sided Pearson's chi-square test. The a priori threshold for statistical significance is P=0.05.||Month 6|
1686521|NCT01162421|3102398|Superiority or Other||Difference in percentage|9.4||||0.316|2-Sided|95.0|-7.09|25.13|||Fisher Exact|Two-sided Fisher Exact test.||Month 3|
1686522|NCT01162421|3102399|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.28||0.755|2-Sided|95.0|-0.6|0.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24|
1686523|NCT01162421|3102399|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.3||0.973|2-Sided|95.0|-0.6|0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18|
1686524|NCT01162421|3102399|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.27||0.339|2-Sided|95.0|-0.8|0.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12|
1686525|NCT01162421|3102399|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.29||0.214|2-Sided|95.0|-0.9|0.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 9|
1686526|NCT01162421|3102399|Superiority or Other||LS Mean Difference|-0.9|Standard Error of the Mean|0.29||0.003|2-Sided|95.0|-1.5|-0.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 6|
1686527|NCT01162421|3102399|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.27||0.102|2-Sided|95.0|-1.0|0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3|
1686528|NCT01162421|3102400|Superiority or Other||LS Mean Difference|2.4|Standard Error of the Mean|3.42||0.49|2-Sided|95.0|-4.4|9.2||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24|
1686529|NCT01162421|3102400|Superiority or Other||LS Mean Difference|5.5|Standard Error of the Mean|3.5||0.122|2-Sided|95.0|-1.5|12.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18|
1686530|NCT01162421|3102400|Superiority or Other||LS Mean Difference|2.9|Standard Error of the Mean|3.3||0.377|2-Sided|95.0|-3.7|9.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12|
1686531|NCT01162421|3102400|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|3.95||0.967|2-Sided|95.0|-7.7|8.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9|
1686532|NCT01162421|3102400|Superiority or Other||LS Mean Difference|-1.5|Standard Error of the Mean|4.51||0.744|2-Sided|95.0|-10.5|7.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6|
1686533|NCT01162421|3102400|Superiority or Other||LS Mean Difference|1.3|Standard Error of the Mean|3.29||0.697|2-Sided|95.0|-5.3|7.9||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3|
1686534|NCT01162421|3102401|Superiority or Other||LS Mean Difference|3.0|Standard Error of the Mean|6.13||0.621|2-Sided|95.0|-9.2|15.3||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24|
1686535|NCT01162421|3102401|Superiority or Other||LS Mean Difference|5.4|Standard Error of the Mean|5.67||0.341|2-Sided|95.0|-5.9|16.7||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18|
1686536|NCT01162421|3102401|Superiority or Other||LS Mean Difference|-2.4|Standard Error of the Mean|5.59||0.67|2-Sided|95.0|-13.5|8.8||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12|
1686537|NCT01162421|3102401|Superiority or Other||LS Mean Difference|0.4|Standard Error of the Mean|5.62||0.937|2-Sided|95.0|-10.8|11.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9|
1686538|NCT01162421|3102401|Superiority or Other||LS Mean Difference|-8.4|Standard Error of the Mean|5.49||0.129|2-Sided|95.0|-19.4|2.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6|
1686539|NCT01162421|3102401|Superiority or Other||LS Mean Difference|-1.0|Standard Error of the Mean|5.28||0.85|2-Sided|95.0|-11.5|9.5||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3|
1686540|NCT01162421|3102402|Superiority or Other||LS Mean Difference|7.1|Standard Error of the Mean|5.54||0.207|2-Sided|95.0|-4.0|18.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 24|
1686541|NCT01162421|3102402|Superiority or Other||LS Mean Difference|6.4|Standard Error of the Mean|5.36||0.238|2-Sided|95.0|-4.3|17.1||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 18|
1686542|NCT01162421|3102402|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|5.28||0.99|2-Sided|95.0|-10.5|10.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 12|
1686543|NCT01162421|3102402|Superiority or Other||LS Mean Difference|5.2|Standard Error of the Mean|5.58||0.352|2-Sided|95.0|-5.9|16.4||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 9|
1690617|NCT01118455|3108497|Superiority or Other|||||||0.467|||||||t-test, 2 sided||||
1686544|NCT01162421|3102402|Superiority or Other||LS Mean Difference|-5.2|Standard Error of the Mean|5.61||0.358|2-Sided|95.0|-16.4|6.0||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 6|
1686545|NCT01162421|3102402|Superiority or Other||LS Mean Difference|-2.3|Standard Error of the Mean|4.96||0.641|2-Sided|95.0|-12.2|7.6||P-values are two-sided and are based on ANCOVA model with treatment group as the fixed effect and Baseline value as the covariate.|ANCOVA|||Month 3|
1686546|NCT01162421|3102403|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|5.86||0.983|2-Sided|95.0|-11.8|11.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24|
1686547|NCT01162421|3102403|Superiority or Other||LS Mean Difference|-0.6|Standard Error of the Mean|5.96||0.916|2-Sided|95.0|-12.5|11.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18|
1686548|NCT01162421|3102403|Superiority or Other||LS Mean Difference|-3.5|Standard Error of the Mean|5.72||0.544|2-Sided|95.0|-14.9|7.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12|
1686549|NCT01162421|3102403|Superiority or Other||LS Mean Difference|-9.4|Standard Error of the Mean|5.84||0.113|2-Sided|95.0|-21.0|2.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 9|
1686550|NCT01162421|3102403|Superiority or Other||LS Mean Difference|-25.5|Standard Error of the Mean|5.9|<|0.001|2-Sided|95.0|-37.3|-13.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6|
1686551|NCT01162421|3102403|Superiority or Other||LS Mean Difference|-12.3|Standard Error of the Mean|5.08|<|0.018|2-Sided|95.0|-22.5|-2.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3|
1686552|NCT01162421|3102404|Superiority or Other||LS Mean Difference|-0.8|Standard Error of the Mean|1.11||0.464|2-Sided|95.0|-3.0|1.4||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24|
1686553|NCT01162421|3102404|Superiority or Other||LS Mean Difference|-0.6|Standard Error of the Mean|1.3||0.649|2-Sided|95.0|-3.2|2.0||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18|
1686554|NCT01162421|3102404|Superiority or Other||LS Mean Difference|-0.8|Standard Error of the Mean|1.14||0.492|2-Sided|95.0|-3.1|1.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12|
1686555|NCT01162421|3102404|Superiority or Other||LS Mean Difference|-2.5|Standard Error of the Mean|1.19||0.04|2-Sided|95.0|-4.9|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9|
1686556|NCT01162421|3102404|Superiority or Other||LS Mean Difference|-4.0|Standard Error of the Mean|1.08|<|0.001|2-Sided|95.0|-6.1|-1.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6|
1686557|NCT01162421|3102404|Superiority or Other||LS Mean Difference|-1.9|Standard Error of the Mean|1.29|<|0.156|2-Sided|95.0|-4.4|0.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3|
1686558|NCT01162421|3102405|Superiority or Other||LS Mean Difference|-0.8|Standard Error of the Mean|1.83||0.661|2-Sided|95.0|-4.5|2.9||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24|
1686559|NCT01162421|3102405|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|2.31||0.837|2-Sided|95.0|-5.1|4.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18|
1686560|NCT01162421|3102405|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|1.95||0.725|2-Sided|95.0|-4.6|3.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 12|
1686561|NCT01162421|3102405|Superiority or Other||LS Mean Difference|-3.7|Standard Error of the Mean|1.87||0.05|2-Sided|95.0|-7.5|0.0||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9|
1686562|NCT01162421|3102405|Superiority or Other||LS Mean Difference|-7.2|Standard Error of the Mean|1.92|<|0.001|2-Sided|95.0|-11.0|-3.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6|
1686563|NCT01162421|3102405|Superiority or Other||LS Mean Difference|-2.8|Standard Error of the Mean|2.26|<|0.22|2-Sided|95.0|-7.3|1.7||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 3|
1686564|NCT01162421|3102406|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|0.77||0.343|2-Sided|95.0|-2.3|0.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24|
1686695|NCT01160380|3102668|Superiority or Other|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms for Day 28 of treatment -ESS|
1686565|NCT01162421|3102406|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|0.94||0.452|2-Sided|95.0|-2.6|1.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18|
1686566|NCT01162421|3102406|Superiority or Other||LS Mean Difference|-1.6|Standard Error of the Mean|0.71||0.028|2-Sided|95.0|-3.0|-0.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 12|
1686567|NCT01162421|3102406|Superiority or Other||LS Mean Difference|-2.2|Standard Error of the Mean|0.81||0.008|2-Sided|95.0|-3.8|-0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 9|
1686568|NCT01162421|3102406|Superiority or Other||LS Mean Difference|-3.4|Standard Error of the Mean|0.79|<|0.001|2-Sided|95.0|-5.0|-1.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6|
1686569|NCT01162421|3102406|Superiority or Other||LS Mean Difference|-1.9|Standard Error of the Mean|0.89|<|0.039|2-Sided|95.0|-3.7|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 3|
1686570|NCT01162421|3102407|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|1.15||0.644|2-Sided|95.0|-2.8|1.8||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 24|
1686571|NCT01162421|3102407|Superiority or Other||LS Mean Difference|-0.6|Standard Error of the Mean|1.58||0.702|2-Sided|95.0|-3.7|2.5||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|||Month 18|
1686572|NCT01162421|3102407|Superiority or Other||LS Mean Difference|-2.0|Standard Error of the Mean|0.96||0.037|2-Sided|95.0|-4.0|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 12|
1686573|NCT01162421|3102407|Superiority or Other||LS Mean Difference|-2.7|Standard Error of the Mean|1.16||0.021|2-Sided|95.0|-5.1|-0.4||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.05.||Month 9|
1686574|NCT01162421|3102407|Superiority or Other||LS Mean Difference|-4.5|Standard Error of the Mean|1.12|<|0.001|2-Sided|95.0|-6.8|-2.3||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.001.||Month 6|
1686575|NCT01162421|3102407|Superiority or Other||LS Mean Difference|-3.5|Standard Error of the Mean|1.18|<|0.004|2-Sided|95.0|-5.9|-1.2||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and Baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P=0.01.||Month 3|
1686576|NCT01162421|3102408|Superiority or Other||Difference in percentage|-16.9||||0.116|2-Sided|95.0|-37.86|4.01|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24|
1686577|NCT01162421|3102408|Superiority or Other||Difference in percentage|10.8||||0.29|2-Sided|95.0|-8.86|30.4|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18|
1686578|NCT01162421|3102408|Superiority or Other||Difference in percentage|16.5||||0.092|2-Sided|95.0|-2.07|35.04|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12|
1686579|NCT01162421|3102408|Superiority or Other||Difference in percentage|2.8||||0.78|2-Sided|95.0|-16.74|22.31|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9|
1686580|NCT01162421|3102408|Superiority or Other||Difference in percentage|19.6||||0.031|2-Sided|95.0|2.74|36.53||The a priori threshold for statistical significance is P=0.05.|Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6|
1686581|NCT01162421|3102408|Superiority or Other||Difference in percentage|12.5||||0.111|2-Sided|95.0|-1.7|27.06|||Fisher Exact|||Month 3|
1686582|NCT01162421|3102409|Superiority or Other||Difference in percentage|-9.5||||0.399|2-Sided|95.0|-31.61|12.56|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24|
1686583|NCT01162421|3102409|Superiority or Other||Difference in percentage|-7.3||||0.528|2-Sided|95.0|-29.74|15.23|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18|
1686584|NCT01162421|3102409|Superiority or Other||Difference in percentage|9.3||||0.413|2-Sided|95.0|-12.82|31.43|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12|
1686585|NCT01162421|3102409|Superiority or Other||Difference in percentage|8.7||||0.451|2-Sided|95.0|-13.85|31.29|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 9|
1686586|NCT01162421|3102409|Superiority or Other||Difference in percentage|20.7||||0.06|2-Sided|95.0|-0.14|41.61|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6|
1686587|NCT01162421|3102409|Superiority or Other||Difference in percentage|15.6||||0.148|2-Sided|95.0|-5.05|36.26|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3|
1686588|NCT01162421|3102410|Superiority or Other||Difference in percentage|-19.6||||0.091|2-Sided|95.0|-41.74|2.62|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 24|
1686589|NCT01162421|3102410|Superiority or Other||Difference in percentage|-14.4||||0.209|2-Sided|95.0|-36.64|7.78|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 18|
1686590|NCT01162421|3102410|Superiority or Other||Difference in percentage|-12.2||||0.281|2-Sided|95.0|-34.04|9.72|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 12|
1686696|NCT01160380|3102669|Superiority or Other|||||||0.378|||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS depression|
1686592|NCT01162421|3102410|Superiority or Other||Difference in percentage|27.0||||0.021|2-Sided|95.0|4.98|48.93||The a priori threshold for statistical significance is P=0.05.|Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 6|
1686593|NCT01162421|3102410|Superiority or Other||Difference in percentage|12.1||||0.281|2-Sided|95.0|-9.79|33.97|||Chi-squared|P-value is based on two-sided Pearson's chi-square test.||Month 3|
1686594|NCT01162421|3102411|Superiority or Other||Difference in percentage|-11.7||||0.095|2-Sided|95.0|-27.0|1.6||P-value is based on two sided Fisher’s exact test.|Fisher Exact||Confidence interval is based on Wilson confidence limits.||
1686595|NCT01162421|3102412|Superiority or Other||LS Mean Difference|-2.22|Standard Error of the Mean|1.403||0.12|2-Sided|95.0|-5.05|0.6||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|||Month 24|
1686596|NCT01162421|3102412|Superiority or Other||LS Mean Difference|-1.46|Standard Error of the Mean|0.667||0.033|2-Sided|95.0|-2.79|-0.12||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P= 0.05.||Month 12|
1686597|NCT01162421|3102412|Superiority or Other||Least squares (LS) Mean Difference|-0.86|Standard Error of the Mean|0.382||0.027|2-Sided|95.0|-1.62|-0.1||P-values are two-sided and are based on repeated measures ANCOVA model with treatment group and visit as the fixed effects and baseline value as the covariate.|ANCOVA|The a priori threshold for statistical significance is P= 0.05.||Month 6|
1686598|NCT01162421|3102413|Superiority or Other||Difference in percentage|-5.3||||0.65|2-Sided|95.0|-28.1|17.5|||Chi-squared|P-value is based on two-sided Pearson’s chi-square test.||Month 24|
1686599|NCT01162421|3102413|Superiority or Other||Difference in percentage|3.2||||0.762|2-Sided|95.0|-17.7|24.1|||Chi-squared|P-value is based on two-sided Pearson’s chi-square test.||Month 6|
1686600|NCT01162421|3102414|Superiority or Other||Difference in percentage|-1.3||||0.907|2-Sided|95.0|-23.4|20.8|||Chi-squared|P-value is based on two-sided Pearson’s chi-square test.|||
1686601|NCT01162122|3102433|Superiority or Other||Group difference (B strain-high risk)|5.1|||||2-Sided|95.0|-1.6|11.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was >10%.|
1686602|NCT01162122|3102433|Superiority or Other||Group difference(H3N2/Wisconsin-highrisk|13.0|||||2-Sided|95.0|5.8|20.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was >10%.|
1686603|NCT01162122|3102433|Superiority or Other||Group difference(H3N2/Brisbane-high risk|12.4|||||2-Sided|95.0|5.2|19.6||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was >10%.|
1686604|NCT01162122|3102433|Superiority or Other||Group difference (B strain-overall)|4.6|||||2-Sided|95.0|0.4|8.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was >10%.|
1686605|NCT01162122|3102433|Superiority or Other||Group difference(H3N2/Wisconsin-overall)|12.6|||||2-Sided|95.0|8.1|17.1||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was >10%.|
1686606|NCT01162122|3102433|Superiority or Other||Group difference (H3N2/Brisbane-overall)|12.5|||||2-Sided|95.0|8.1|16.9||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 heterologous strains was >10%.|
1686607|NCT01162122|3102434|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference (B strain-high risk)|4.8|||||2-Sided|95.0|-2.1|11.8|||||||
1686608|NCT01162122|3102434|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference(H3N2Wisconsin-high risk|12.6|||||2-Sided|95.0|5.0|20.2|||||||
1686609|NCT01162122|3102434|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference(H3N2/Brisbane-high risk|12.3|||||2-Sided|95.0|4.8|19.9|||||||
1686610|NCT01162122|3102434|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Slope|4.0|||||2-Sided|95.0|-0.4|8.4|||||||
1686611|NCT01162122|3102434|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference(H3N2/Wisconsin-overall)|11.9|||||2-Sided|95.0|7.3|16.6|||||||
1686612|NCT01162122|3102434|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 heterologous strains was ≥-10%.|Group difference (H3N2/Brisbane-overall)|11.3|||||2-Sided|95.0|6.7|15.9|||||||
1686613|NCT01162122|3102435|Superiority or Other||GMT ratio (B strain-high risk)|1.13|||||2-Sided|95.0|0.97|1.31||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was >1.5.|
1686614|NCT01162122|3102435|Superiority or Other||GMT ratio(H3N2/Wisconsin-high risk)|1.28|||||2-Sided|95.0|1.1|1.48||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was >1.5.|
1686615|NCT01162122|3102435|Superiority or Other||GMT ratio (H3N2/Brisbane-high risk)|1.36|||||2-Sided|95.0|1.15|1.61||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was >1.5.|
1686616|NCT01162122|3102435|Superiority or Other||GMT ratio (B strain-overall)|1.09|||||2-Sided|95.0|0.99|1.21||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was >1.5.|
1686697|NCT01160380|3102669|Superiority or Other|||||||0.933|||||||Wilcoxon (Mann-Whitney)|||Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS anxiety|
1686617|NCT01162122|3102435|Superiority or Other||GMT ratio(H3N2/Wisconsin-overall)|1.38|||||2-Sided|95.0|1.25|1.52||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was >1.5.|
1686618|NCT01162122|3102435|Superiority or Other||GMT ratio (H3N2/Brisbane-overall)|1.49|||||2-Sided|95.0|1.33|1.67||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 heterologous strains was >1.5.|
1686619|NCT01162122|3102436|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was >0.67.|GMT Ratio (B strain-high risk group)|1.11|||||2-Sided|95.0|0.95|1.3|||||||
1686620|NCT01162122|3102436|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was >0.67.|GMT Ratio(H3N2/Wisconsin-high risk group|1.29|||||2-Sided|95.0|1.1|1.5|||||||
1686621|NCT01162122|3102436|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was >0.67.|GMT Ratio(H3N2/Brisbane-high risk group)|1.35||||||95.0|1.13|1.61|||||||
1686622|NCT01162122|3102436|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was ≥0.67.|GMT Ratio (B strain-overall)|1.09|||||2-Sided|95.0|0.98|1.21|||||||
1686623|NCT01162122|3102436|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was >0.67.|GMT Ratio (H3N2/Wisconsin-overall)|1.36|||||2-Sided|95.0|1.23|1.5|||||||
1686624|NCT01162122|3102436|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 heterologous strains was >0.67.|GMT Ratio (H3N2/Brisbane-overall)|1.45|||||2-Sided|95.0|1.29|1.63|||||||
1686625|NCT01162122|3102437|Superiority or Other||Group difference (B strain)|4.9|||||2-Sided|95.0|1.5|8.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was >10%.|
1686626|NCT01162122|3102437|Superiority or Other||Group difference (H3N2 strain)|13.0|||||2-Sided|95.0|9.5|16.6||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was >10%.|
1686627|NCT01162122|3102437|Superiority or Other||Group difference (H1N1 strain)|9.9|||||2-Sided|95.0|6.4|13.3||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was >10%.|
1686628|NCT01162122|3102441|Superiority or Other||GMT ratio (B strain)|1.11|||||2-Sided|95.0|1.03|1.21||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was >1.5.|
1686629|NCT01162122|3102441|Superiority or Other||GMT ratio (H3N2 strain)|1.54|||||2-Sided|95.0|1.42|1.68||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was >1.5.|
1686630|NCT01162122|3102441|Superiority or Other||GMT ratio (H1N1 strain)|1.32|||||2-Sided|95.0|1.2|1.45||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was >1.5.|
1686631|NCT01162122|3102442|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (B strain)|5.0|||||2-Sided|95.0|1.4|8.5|||||||
1686632|NCT01162122|3102442|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (H3N2 strain)|13.5|||||2-Sided|95.0|9.8|17.2|||||||
1686633|NCT01162122|3102442|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%|Group difference (H1N1 strain)|11.1|||||2-Sided|95.0|7.5|14.6|||||||
1686634|NCT01162122|3102443|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was >0.67.|GMT ratio (B strain)|1.12|||||2-Sided|95.0|1.03|1.21|||||||
1686635|NCT01162122|3102443|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was >0.67.|GMT ratio (H3N2 strain)|1.57|||||2-Sided|95.0|1.44|1.72|||||||
1686636|NCT01162122|3102443|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was >0.67.|GMT ratio (H1N1 strain)|1.38|||||2-Sided|95.0|1.25|1.52|||||||
1686637|NCT01162122|3102447|Superiority or Other||Group difference (B strain)|5.1|||||2-Sided|95.0|2.9|7.2||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was >10%.|
1686638|NCT01162122|3102447|Superiority or Other||Group difference (H3N2 strain)|12.7|||||2-Sided|95.0|10.6|14.8||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was >10%.|
1686639|NCT01162122|3102447|Superiority or Other||Group difference (H1N1 strain)|8.9|||||2-Sided|95.0|6.9|10.9||||||Superiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for at least 2 homologous strains was >10%.|
1686640|NCT01162122|3102448|Superiority or Other||GMT ratio (B strain)|1.14|||||2-Sided|95.0|1.08|1.2||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was >1.5.|
1686641|NCT01162122|3102448|Superiority or Other||GMT ratio (H3N2 strain)|1.6|||||2-Sided|95.0|1.51|1.68||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was >1.5.|
1686642|NCT01162122|3102448|Superiority or Other||GMT ratio (H1N1 strain)|1.37|||||2-Sided|95.0|1.29|1.46||||||Superiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for at least 2 homologous strains was >1.5.|
1686643|NCT01162122|3102449|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (B strain)|5.2|||||2-Sided|95.0|3.0|7.4|||||||
1686644|NCT01162122|3102449|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (H3N2 strain)|12.7|||||2-Sided|95.0|10.5|14.9|||||||
1686645|NCT01162122|3102449|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 differences in seroconversion rates for all 3 homologous strains was ≥-10%.|Group difference (H1N1 strain)|9.2|||||2-Sided|95.0|7.1|11.3|||||||
1686646|NCT01162122|3102450|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was >0.67.|GMT ratio (B strain)|1.15|||||2-Sided|95.0|1.08|1.21|||||||
1686647|NCT01162122|3102450|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was >0.67.|GMT ratio (H3N2 strain)|1.61|||||2-Sided|95.0|1.52|1.7|||||||
1686648|NCT01162122|3102450|Non-Inferiority or Equivalence|Non-inferiority was established if the lower bound of the 95% CI for the day 22 vaccine group GMT ratios for all 3 homologous strains was >0.67.|GMT ratio (H1N1 strain)|1.4|||||2-Sided|95.0|1.32|1.49|||||||
1686649|NCT01162122|3102451|Non-Inferiority or Equivalence|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|0.96|||||2-Sided|95.0|0.87|1.05|||||||
1686650|NCT01162122|3102451|Non-Inferiority or Equivalence|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|0.96|||||2-Sided|95.0|0.87|1.05|||||||
1686651|NCT01162122|3102451|Non-Inferiority or Equivalence|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (B strain)|1.0|||||2-Sided|95.0|0.91|1.1|||||||
1686652|NCT01162122|3102451|Non-Inferiority or Equivalence|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|0.98|||||2-Sided|95.0|0.89|1.07|||||||
1686653|NCT01162122|3102451|Non-Inferiority or Equivalence|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|0.99|||||2-Sided|95.0|0.9|1.08|||||||
1686654|NCT01162122|3102451|Non-Inferiority or Equivalence|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H3N2 strain)|1.01|||||2-Sided|95.0|0.92|1.11|||||||
1686655|NCT01162122|3102451|Non-Inferiority or Equivalence|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|0.94|||||2-Sided|95.0|0.85|1.05|||||||
1686656|NCT01162122|3102451|Non-Inferiority or Equivalence|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|1.05|||||2-Sided|95.0|0.95|1.17|||||||
1686657|NCT01162122|3102451|Non-Inferiority or Equivalence|The 95% CIs of GMT ratios for the pairwise lot-to-lot group comparisons should fall within the equivalence range of 0.67 to 1.5.|GMT ratio (H1N1 strain)|1.12|||||2-Sided|95.0|1.0|1.24|||||||
1686658|NCT01162005|3102456|Superiority or Other|||||||0.001|||||||t-test, 2 sided||||
1686659|NCT01161628|3102479|Superiority or Other||||||<|0.5|||||||t-test, 2 sided|||Null hypothesis: p (CR rate) is 0.5 or less versus... Alternative hypothesis: p >0.5 A sample size of 25 patients gives 90% power with an alpha = 0.05|
1686660|NCT01161472|3102525|Superiority or Other||LS Mean Difference|-0.0661|Standard Error of the Mean|0.8277||0.9366|2-Sided|95.0|-1.7202|1.588|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.|
1686661|NCT01161472|3102525|Superiority or Other||LS Mean Difference|0.2684|Standard Error of the Mean|0.8243||0.7458|2-Sided|95.0|-1.3788|1.9157|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.|
1686662|NCT01161472|3102527|Superiority or Other||LS Mean Difference|-1.6251|Standard Error of the Mean|5.0346||0.7485|2-Sided|95.0|-11.7926|8.5425|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.|
1686663|NCT01161472|3102527|Superiority or Other||LS Mean Difference|0.0068|Standard Error of the Mean|4.8707||0.9989|2-Sided|95.0|-9.8297|9.8433|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.|
1686664|NCT01161472|3102529|Superiority or Other||LS Mean Difference|-19.921|Standard Error of the Mean|12.4482||0.1162|2-Sided|95.0|-44.9634|5.1215|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.|
1686665|NCT01161472|3102529|Superiority or Other||LS Mean Difference|3.6629|Standard Error of the Mean|12.4945||0.7707|2-Sided|95.0|-21.4729|28.7987|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.|
1686666|NCT01161472|3102531|Superiority or Other||LS Mean Difference|0.0209|Standard Error of the Mean|0.0263||0.4308|2-Sided|95.0|-0.032|0.0738|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.|
1686698|NCT01160380|3102669|Superiority or Other|||||||0.315|||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression|
1686667|NCT01161472|3102531|Superiority or Other||LS Mean Difference|-0.0035|Standard Error of the Mean|0.0265||0.8944|2-Sided|95.0|-0.0569|0.0498|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.|
1686668|NCT01161472|3102533|Superiority or Other||LS Mean Difference|-0.0085|Standard Error of the Mean|0.0119||0.4785|2-Sided|95.0|-0.0325|0.0154|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.|
1686669|NCT01161472|3102533|Superiority or Other||LS Mean Difference|-0.0037|Standard Error of the Mean|0.0115||0.7502|2-Sided|95.0|-0.0268|0.0194|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.|
1686670|NCT01161472|3102535|Superiority or Other||LS Mean Difference|-0.0203|Standard Error of the Mean|0.0173||0.2459|2-Sided|95.0|-0.0551|0.0145|||ANCOVA|||ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.|
1686671|NCT01161472|3102535|Superiority or Other||Least square (LS) Mean Difference|-0.0285|Standard Error of the Mean|0.018||0.1198|2-Sided|95.0|-0.0647|0.0077|||ANCOVA|||Analysis of Covariance (ANCOVA) was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates.|
1686672|NCT01161446|3102537|Non-Inferiority|Self-testing was to be considered non-inferior with respect to the number of reported male CAI partners if the upper bound of the 95% CI for the fold-difference in the number of partners between the two arms (self ÷ standard testing) fell below 2.|Incidence Rate Ratio|0.92|||||2-Sided|95.0|0.64|1.33|||||The home testing arm represents the numerator and the standard testing arm the denominator.||
1686673|NCT01161446|3102538|Non-Inferiority|Home testing was to be considered non-inferior to standard testing with respect to STI prevalence if the upper bound of the 95% confidence interval for the difference between the two arms (home - standard) fell below 10%.|Difference in proportions|-0.068|||||2-Sided|95.0|-0.16|0.016|||||||
1686674|NCT01161446|3102539|Non-Inferiority|Non-inferiority bound: Self-testing was to be considered non-inferior to standard testing if the upper bound of the 95% confidence interval for the odds ratio fell below 2.|Odds Ratio (OR)|1.07|||||2-Sided|95.0|0.61|1.9|||||The home testing arm represents the numerator and the standard testing arm the denominator.||
1686675|NCT01161446|3102540|Superiority||||||<|0.0001|||||||t-test, 2 sided||||
1686676|NCT01161329|3102552|Superiority or Other|||||||0.09||||||The p-value for the man differnece in SPPB between grpoups att three months was 0.09|Wilcoxon (Mann-Whitney)||||
1686677|NCT01161329|3102553|Non-Inferiority or Equivalence|It was estimated that 128 individuals would be required for 80 % Power with a type I error of 5% to detect a 2-point difference in BBS with a standard deviation of +/- 4 points. Because of the slow recruitment and the statistically significant improvements observed in the primary outcome in the intervention group during an interim analysis the study was finalized with fewer participants than had been initially calculated.||||||0.001||||||The Bonferroni method was used to assess longitudinal Changes and correct for multiple comparisons, with significance set at p<0.016 to minimize the risk for type I errors.|Wilcoxon (Mann-Whitney)|||Intention-to-treat analysis was performed to assess the effects on the outcome measures. Between-group differences for all outcome measures were analyzed using Mann-Whitney U-test.|
1686678|NCT01161160|3102581|Non-Inferiority|Equivalence criteria were fulfilled if the 2-sided 95% confidence limits on the geometric mean titer (GMT) ratio was within the interval 0.5 to 2.0.|Adjusted GMT ratio|0.96|||||2-Sided|95.0|0.73|1.26||||||To demonstrate the immunological equivalence of HA antigen adjuvanted with AS03B manufactured in Quebec (Arepanrix™) and HA antigen adjuvanted with AS03B manufactured in Dresden (Pandemrix™), 21 days after vaccination.|
1686679|NCT01160744|3102629|Superiority or Other (legacy)|||||||0.1597|||||||t-test, 2 sided||||
1686680|NCT01160744|3102629|Superiority or Other (legacy)|||||||0.1571|||||||t-test, 2 sided||||
1686681|NCT01160744|3102630|Superiority or Other (legacy)||Odds Ratio (OR)|1.37||||0.3962|2-Sided|90.0|0.74|2.52|||Chi-squared||||
1686682|NCT01160744|3102630|Superiority or Other (legacy)||Odds Ratio (OR)|2.48||||0.0316|2-Sided|90.0|1.22|5.02|||Chi-squared||||
1686683|NCT01160744|3102633|Superiority or Other (legacy)||Hazard Ratio (HR)|0.93||||0.6847|2-Sided|90.0|0.68|1.27|||Log Rank||||
1686684|NCT01160744|3102633|Superiority or Other (legacy)||Hazard Ratio (HR)|1.03||||0.8916|2-Sided|90.0|0.74|1.42|||Log Rank||||
1686685|NCT01160744|3102634|Superiority or Other (legacy)||Odds Ratio (OR)|2.66||||0.007|2-Sided|90.0|1.45|4.86|||Chi-squared||||
1686686|NCT01160744|3102634|Superiority or Other (legacy)||Odds Ratio (OR)|1.58||||0.1797|2-Sided|90.0|0.9|2.78|||Chi-squared||||
1686687|NCT01160744|3102635|Superiority or Other (legacy)||Hazard Ratio (HR)|0.88||||0.5215|2-Sided|90.0|0.64|1.22|||Log Rank||||
1686688|NCT01160744|3102635|Superiority or Other (legacy)||Hazard Ratio (HR)|0.75||||0.1318|2-Sided|90.0|0.55|1.03|||Log Rank||||
1686689|NCT01160640|3102637|Superiority or Other|||||||0.74||||||P-value for proportion of women who experienced resolution of clinical signs and symptoms of PID at the 3-day visit|Fisher Exact||||
1686690|NCT01160640|3102638|Superiority or Other|||||||0.16||||||P-value for proportion of women who did not have M. genitalium detected in the cervix or endometrium at the 30-day visit|Fisher Exact||||
1686691|NCT01160640|3102640|Superiority or Other|||||||0.046||||||P-value for proportion of women who had clearance of anaerobic organisms from the endometrium at the 30-day visit|Fisher Exact||||
1686692|NCT01160380|3102668|Superiority or Other|||||||0.635|||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm|
1686693|NCT01160380|3102668|Superiority or Other|||||||0.051|||||||Wilcoxon (Mann-Whitney)|||Day 1 and Day 28 of treatment for the Armodafinil arm- ESS|
1686694|NCT01160380|3102668|Superiority or Other|||||||0.05|||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-ESS|
1686701|NCT01160380|3102669|Superiority or Other|||||||0.005|||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS anxiety|
1686702|NCT01160380|3102669|Superiority or Other|||||||0.316|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment- HADS depression|
1686703|NCT01160380|3102669|Superiority or Other|||||||0.945|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment- HADS anxiety|
1686704|NCT01160380|3102670|Superiority or Other|||||||0.495|||||||t-test, 2 sided|||Day 28 vs. Day 56of treatment for the Armodafinil arm- FACIT-F total|
1686705|NCT01160380|3102670|Superiority or Other|||||||0.192|||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Armodafinil arm- FACIT-F total|
1686706|NCT01160380|3102670|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm- FACIT-F total|
1686707|NCT01160380|3102670|Superiority or Other||||||<|0.559|||||||t-test, 2 sided|||Comparison between arms for Day 28 of treatment- FACIT-F total|
1686708|NCT01160380|3102671|Superiority or Other|||||||0.863|||||||t-test, 2 sided|||Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Backward test|
1686709|NCT01160380|3102671|Superiority or Other|||||||0.692|||||||t-test, 2 sided|||Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Forward test|
1686710|NCT01160380|3102671|Superiority or Other|||||||0.805|||||||t-test, 2 sided|||Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Backward test|
1686711|NCT01160380|3102671|Superiority or Other|||||||0.028|||||||t-test, 2 sided|||Day 1 vs. day 28 of treatment for the Armodafinil arm-Digit Span Test score-Forward test|
1686712|NCT01160380|3102671|Superiority or Other|||||||0.656|||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Backward test|
1686713|NCT01160380|3102671|Superiority or Other|||||||0.037|||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Forward test|
1686714|NCT01160380|3102671|Superiority or Other|||||||0.531|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment for the Digit Span Test score-Backward test|
1686715|NCT01160380|3102671|Superiority or Other|||||||0.636|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment for the Digit Span Test score-Forward test|
1686716|NCT01160380|3102672|Superiority or Other|||||||0.089|||||||t-test, 2 sided|||Day 28 vs. Day 56 of treatment for the Armodafinil arm|
1686717|NCT01160380|3102672|Superiority or Other|||||||0.239|||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm|
1686718|NCT01160380|3102672|Superiority or Other|||||||0.984|||||||t-test, 2 sided|||Day 1 vs. Day 28 of treatment for the Placebo-First arm|
1686719|NCT01160380|3102672|Superiority or Other|||||||0.699|||||||t-test, 2 sided|||Comparison between arms at day 28|
1686720|NCT01160380|3102673|Superiority or Other|||||||0.973|||||||t-test, 2 sided|||Comparison between Day 28 and Day 56 of treatment for the Armodafinil arm|
1686721|NCT01160380|3102673|Superiority or Other|||||||0.369|||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Armodafinil arm|
1686722|NCT01160380|3102673|Superiority or Other|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Day 1 vs. Day 28 of treatment for the Placebo-First arm|
1686723|NCT01160380|3102673|Superiority or Other|||||||0.954|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment|
1686724|NCT01160380|3102674|Superiority or Other|||||||0.449|||||||t-test, 2 sided|||Comparison between Day 28 and Day 56 of treatment for the armodafinil arm|
1686725|NCT01160380|3102674|Superiority or Other||||||<|0.002|||||||Wilcoxon (Mann-Whitney)|||Comparison between Day 1 and day 28|
1686726|NCT01160380|3102674|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Comparison between Day 1 and Day 28|
1686727|NCT01160380|3102674|Superiority or Other||||||<|0.289|||||||Wilcoxon (Mann-Whitney)|||Comparison between arms at Day 28 of treatment|
1686728|NCT01160289|3102678|Superiority or Other||LS mean of treatment difference|-1.201||||0.676||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686729|NCT01160289|3102678|Superiority or Other||LS mean of treatment difference|7.056||||0.019||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686730|NCT01160289|3102678|Superiority or Other||LS mean treatment difference|-3.225||||0.277||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686731|NCT01160289|3102678|Superiority or Other||LS Mean of treatment difference|5.031||||0.103||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686732|NCT01160289|3102679|Superiority or Other||LS mean of treatment difference|-0.072||||0.776||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686733|NCT01160289|3102679|Superiority or Other||LS mean of treatment difference|0.387||||0.142||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686734|NCT01160289|3102679|Superiority or Other||LS mean of treatment difference|-0.465||||0.076||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686735|NCT01160289|3102679|Superiority or Other||LS Mean of treatment difference|-0.006||||0.984||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686736|NCT01160289|3102680|Superiority or Other||LS mean of treatment difference|0.128||||0.968||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686737|NCT01160289|3102680|Superiority or Other||LS mean of treatment difference|-1.629||||0.627||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686804|NCT01160211|3102696|Superiority|Functional wellbeing (FWB)|Least squares difference|-1.36|Standard Error of the Mean|0.649||0.0371|2-Sided|95.0|-2.64|0.08|||ANCOVA||||
1686738|NCT01160289|3102680|Superiority or Other||LS mean of treatment difference|0.78||||0.814||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686739|NCT01160289|3102680|Superiority or Other||LS mean of treatment difference|-0.977||||0.776||95.0||||The p-value is for the percent change from baseline to Week 12 in LDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686740|NCT01160289|3102680|Superiority or Other||LS mean of treatment difference|-18.75|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686741|NCT01160289|3102680|Superiority or Other||LS mean of treatment difference|-9.216|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686742|NCT01160289|3102680|Superiority or Other||LS mean of treatment difference|-18.547|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686743|NCT01160289|3102680|Superiority or Other||LS Mean of treatment difference|-9.014|||<|0.001||95.0||||The p-value is for the percent change from baseline to Week 12 in HDL-C; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686744|NCT01160289|3102681|Superiority or Other||LS mean of treatment difference|-0.032||||0.726||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686745|NCT01160289|3102681|Superiority or Other||LS mean of treatment difference|-0.016||||0.866||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686746|NCT01160289|3102681|Superiority or Other||LS mean of treatment difference|-0.227||||0.017||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686747|NCT01160289|3102681|Superiority or Other||LS mean of treatment difference|-0.211||||0.031||95.0||||The p-value is for the change from baseline to Week 12 in triglycerides; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686748|NCT01160289|3102681|Superiority or Other||LS mean of treatment difference|-0.189||||0.056||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686749|NCT01160289|3102681|Superiority or Other||LS mean of treatment difference|-0.124||||0.224||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686750|NCT01160289|3102681|Superiority or Other||LS mean of treatment difference|-0.216||||0.033||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686751|NCT01160289|3102681|Superiority or Other||LS Mean of treatment difference|-0.152||||0.148||95.0||||The p-value is for the change from baseline to Week 12 in total cholesterol; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686752|NCT01160289|3102682|Superiority or Other||LS mean of treatment difference|-0.334||||0.029||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686753|NCT01160289|3102682|Superiority or Other||LS mean of treatment difference|-0.084||||0.599||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686754|NCT01160289|3102682|Superiority or Other||LS mean of treatment difference|-0.12||||0.443||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686755|NCT01160289|3102682|Superiority or Other||LS mean of treatment difference|0.13||||0.423||95.0||||Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686756|NCT01160289|3102683|Superiority or Other|||||||0.433||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA||||
1686757|NCT01160289|3102683|Superiority or Other|||||||0.441||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA||||
1686758|NCT01160289|3102683|Superiority or Other|||||||0.259||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA||||
1686759|NCT01160289|3102683|Superiority or Other|||||||0.671||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA||||
1686760|NCT01160289|3102683|Superiority or Other|||||||0.009||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level ≥340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA||||
1686761|NCT01160289|3102683|Superiority or Other|||||||0.198||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level <340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA||||
1686762|NCT01160289|3102683|Superiority or Other|||||||0.46||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level <340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA||||
1686763|NCT01160289|3102683|Superiority or Other|||||||0.656||||||The p-value is for the change from baseline to Week 12 in the IIEF EF domain scores reported by optimal testosterone level <340 ng/dL; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|ANCOVA||||
1686764|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.948|Standard Error of the Mean|0.326||0.004||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686765|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.729|Standard Error of the Mean|0.335||0.03||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686766|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.568|Standard Error of the Mean|0.334||0.09||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686767|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.349|Standard Error of the Mean|0.343||0.31||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686768|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.391|Standard Error of the Mean|0.245||0.111||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686769|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.3|Standard Error of the Mean|0.252||0.235||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686770|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.179|Standard Error of the Mean|0.251||0.477||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686771|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.088|Standard Error of the Mean|0.258||0.734||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF SD domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686772|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.561|Standard Error of the Mean|0.38||0.141||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686773|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.168|Standard Error of the Mean|0.392||0.668||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686774|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.616|Standard Error of the Mean|0.39||0.115||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686775|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.223|Standard Error of the Mean|0.401||0.579||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF OF domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686776|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.612|Standard Error of the Mean|0.447||0.172||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686777|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.652|Standard Error of the Mean|0.46||0.158||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686778|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.039|Standard Error of the Mean|0.458||0.931||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686779|NCT01160289|3102685|Superiority or Other||LS mean of treatment difference|-0.079|Standard Error of the Mean|0.472||0.867||95.0||||The p-value is for the change from baseline to Week 12 in the IIEF IS domain score; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity.|Mixed model repeated measures analysis||||
1686780|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|-7.214|Standard Error of the Mean|5.349||0.178||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686781|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|-8.808|Standard Error of the Mean|5.457||0.107||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686782|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|5.796|Standard Error of the Mean|5.499||0.293||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686783|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|4.202|Standard Error of the Mean|5.603||0.454||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q5; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686784|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|-10.292|Standard Error of the Mean|5.312||0.054||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686785|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|-11.266|Standard Error of the Mean|5.418||0.038||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686786|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|5.054|Standard Error of the Mean|5.463||0.356||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686787|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|4.079|Standard Error of the Mean|5.566||0.464||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q4; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686788|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|-2.893|Standard Error of the Mean|5.067||0.568||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686789|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|-5.349|Standard Error of the Mean|5.165||0.301||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686790|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|9.159|Standard Error of the Mean|5.206||0.079||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686791|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|6.703|Standard Error of the Mean|5.302||0.207||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q3; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686792|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|-6.578|Standard Error of the Mean|4.45||0.14||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686793|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|-7.092|Standard Error of the Mean|4.535||0.119||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686794|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|1.844|Standard Error of the Mean|4.573||0.687||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686795|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|1.33|Standard Error of the Mean|4.658||0.775||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q2; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686796|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|-7.404|Standard Error of the Mean|3.157||0.02||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686797|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|-4.674|Standard Error of the Mean|3.218||0.147||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686798|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|-1.552|Standard Error of the Mean|3.253||0.634||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686799|NCT01160289|3102686|Superiority or Other||LS mean of treatment difference|1.178|Standard Error of the Mean|3.312||0.722||95.0||||"The p-value is for the change from baseline to Week 12 in the percentage of Yes responses on the SEP diary, Q1; Conducted at a 2-sided alpha level of 0.10 without adjustment for multiplicity."|Mixed model repeated measures analysis||||
1686800|NCT01160289|3102687|Superiority or Other|||||||0.498||||||The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.|ANCOVA|The model included tx grp, baseline IIEF EF domain score, baseline testosterone level, tx grp*baseline IIEF, tx grp*testosterone level interactions.||Only the treatment effects of the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.|
1686801|NCT01160289|3102687|Superiority or Other|||||||0.5||||||The p-value was 1-sided and adjusted for multiple comparisons. The level of significance was 1-sided of 0.04.|ANCOVA|Treatment group (tx grp), baseline IIEF EF domain score, baseline testosterone level, tx grp*baseline IIEF, tx grp*testosterone level interactions.||Only the treatment effects of 1 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil and the treatment effects of 5 mg LY2452473 and 5 mg tadalafil versus 5 mg tadalafil were analyzed.|
1686802|NCT01160211|3102696|Superiority|Breast cancer subscale (BCS)|Leasst squares difference|-0.69|Standard Error of the Mean|0.68||0.31|2-Sided|95.0|-2.03|0.65|||ANCOVA||||
1686803|NCT01160211|3102696|Superiority|Breast cancer subscale (BCS)|Least squares difference|0.04|Standard Error of the Mean|0.681||0.9552|2-Sided|95.0|-1.3|1.38|||ANCOVA||||
1686805|NCT01160211|3102696|Superiority|Functional wellbeing (FWB)|Least squares difference|-0.92|Standard Error of the Mean|0.651||0.1598|2-Sided|95.0|-2.2|0.36|||ANCOVA||||
1686806|NCT01160211|3102696|Superiority|Emotional wellbeing (EWB)|Least squares difference|0.44|Standard Error of the Mean|0.564||0.435|2-Sided|95.0|-0.67|1.55|||ANCOVA||||
1686807|NCT01160211|3102696|Superiority|Emotional wellbeing (EWB)|Least squares difference|0.45|Standard Error of the Mean|0.565||0.4284|2-Sided|95.0|-0.66|1.56|||ANCOVA||||
1686808|NCT01160211|3102696|Superiority|Social family wellbeing (SWB)|Least squares difference|-0.53|Standard Error of the Mean|0.699||0.4471|2-Sided|95.0|-1.91|0.84|||ANCOVA||||
1686809|NCT01160211|3102696|Superiority|Social family wellbeing (SWB)|Least sqaures difference|-0.21|Standard Error of the Mean|0.699||0.7672|2-Sided|95.0|-1.58|1.17|||ANCOVA||||
1686810|NCT01160211|3102696|Superiority|Physical well-being (PWB)|Least squares difference|-0.96|Standard Error of the Mean|0.689||0.1666|2-Sided|95.0|-2.31|0.4|||ANCOVA||||
1686811|NCT01160211|3102696|Superiority|Physical well-being (PWB)|Least squares difference|-1.03|Standard Error of the Mean|0.69||0.1369|2-Sided|95.0|-2.39|0.33|||ANCOVA||||
1686812|NCT01160211|3102696|Superiority|FACT-B trial outcome index (TOI)|Least squares difference|-2.94|Standard Error of the Mean|1.499||0.0506|2-Sided|95.0|-5.89|0.01|||ANCOVA||||
1686813|NCT01160211|3102696|Superiority|FACT-B trial outcome index (TOI)|Least squares difference|-1.89|Standard Error of the Mean|1.498||0.2088|2-Sided|95.0|-4.84|1.06|||ANCOVA||||
1686814|NCT01160211|3102696|Superiority|FACT-G total score|Least squares difference|-2.5|Standard Error of the Mean|1.739||0.1509|2-Sided|95.0|-5.93|0.92|||ANCOVA||||
1686815|NCT01160211|3102696|Superiority|FACT-G total score|Least square difference|-1.79|Standard Error of the Mean|1.739||0.3032|2-Sided|95.0|-5.22|1.63|||ANCOVA||||
1686816|NCT01160211|3102696|Superiority|FACT-B total score|Least saquares defference|-3.15|Standard Error of the Mean|2.107||0.1364|2-Sided|95.0|-7.29|1.0|||ANCOVA||||
1686817|NCT01160211|3102696|Superiority|FACT-B total score|Least squares difference|-1.75|Standard Error of the Mean|2.102||0.4061|2-Sided|95.0|-5.88|2.39|||ANCOVA||||
1686818|NCT01160211|3102699|Superiority||Odds Ratio (OR)|1.492||||0.2829|2-Sided|95.0|0.685|3.296|||Exact Test||||
1686819|NCT01160211|3102699|Superiority||Odds Ratio (OR)|2.83||||0.0017|2-Sided|95.0|1.426|5.888|||exact test||||
1686820|NCT01160211|3102700|Superiority||Hazard Ratio (HR)|0.91||||0.718|2-Sided|95.0|0.55|1.51|||Log Rank||||
1686821|NCT01160211|3102700|Superiority||Hazard Ratio (HR)|0.6||||0.07|2-Sided|95.0|0.35|1.04|||Log Rank||||
1686822|NCT01160211|3102701|Superiority||Hazard Ratio (HR)|0.74||||0.0824|2-Sided|95.0|0.53|1.04|||Log Rank||||
1686823|NCT01160211|3102701|Superiority||Hazard Ratio (HR)|0.85||||0.3159|2-Sided|95.0|0.62|1.17|||Log Rank||||
1686824|NCT01160211|3102702|Superiority||Hazard Ratio (HR)|0.62||||0.0063|2-Sided|95.0|0.45|0.88||Pike estimate of the treatment hazard ratio, <1 indicates a lower risk compared with trastuzumab + AI.|Log Rank|using a two-sided stratified log-rank test (based on stratification factors)||Null hypothesis H0: λ ≥ 1 or to reject it in favor of the alternative hypothesis HA: λ <1, where λ is the hazard ratio (HR) between Treatment Group A and Treatment Group B for progression-free survival.|
1686825|NCT01160198|3102704|Superiority or Other||Mean Difference (Final Values)|0.2||||1|2-Sided|95.0|-0.58|0.98|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 8|
1686826|NCT01160198|3102704|Superiority or Other||Mean Difference (Final Values)|0.1||||1|2-Sided|95.0|-0.53|0.65|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 6|
1686827|NCT01160198|3102704|Superiority or Other||Mean Difference (Final Values)|0.0||||1|2-Sided|95.0|-0.45|0.42|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 4|
1686828|NCT01160198|3102704|Superiority or Other||Mean Difference (Final Values)|-0.1||||1|2-Sided|95.0|-0.29|0.15|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100mg 1 once-daily at Week 2|
1686829|NCT01160198|3102704|Superiority or Other||Mean Difference (Final Values)|-0.1||||1|2-Sided|95.0|-0.84|0.72|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 8|
1686830|NCT01160198|3102704|Superiority or Other||Mean Difference (Final Values)|-0.1||||1|2-Sided|95.0|-0.68|0.51|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 6|
1686831|NCT01160198|3102704|Superiority or Other||Mean Difference (Final Values)|-0.2||||1|2-Sided|95.0|-0.58|0.29|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100 mg 1 once-daily at Week 4|
1686832|NCT01160198|3102704|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.49|2-Sided|95.0|-0.35|0.09|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100mg 1 once-daily at Week 2|
1686833|NCT01160198|3102704|Superiority or Other||Mean Difference (Final Values)|-0.3||||1|2-Sided|95.0|-1.05|0.53|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 8|
1686834|NCT01160198|3102704|Superiority or Other||Mean Difference (Final Values)|-0.1||||1|2-Sided|95.0|-0.75|0.46|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 6|
1686835|NCT01160198|3102704|Superiority or Other||Mean Difference (Final Values)|-0.1||||1||95.0|-0.57|0.31|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 4|
1686836|NCT01160198|3102704|Superiority or Other||Mean Difference (Final Values)|-0.1||||1|2-Sided|95.0|-0.29|0.17|||Repeated Measure ANOVA model|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily at Week 2|
1686837|NCT01160198|3102705|Superiority or Other|||||||0.7|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 twice-daily vs. Ferrous ascorbate 100mg 1 once-daily|
1686838|NCT01160198|3102705|Superiority or Other|||||||0.911|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous ascorbate 100mg 1 once-daily|
1690618|NCT01118455|3108497|Superiority or Other|||||||0.426|||||||t-test, 2 sided||||
1686839|NCT01160198|3102705|Superiority or Other|||||||0.788|||||||Chi-squared|||Ferrous bisglycinate chelate 60 mg 1 once-daily vs. Ferrous bisglycinate chelate 60 mg 1 twice-daily|
1686840|NCT01160198|3102707|Superiority or Other||||||<|0.0001|||||||Paired t-test|||Baseline Hb vs. Hb at Week 8 for Ferrous bisglycinate chelate 60 mg 1 twice-daily|
1686841|NCT01160198|3102707|Superiority or Other||||||<|0.0001|||||||Paired t-test|||Baseline Hb vs. Hb at Week 8 for Ferrous bisglycinate chelate 60 mg 1 once-daily|
1686842|NCT01159938|3102711|Superiority or Other||LS Mean Difference|0.13||||0.436|2-Sided|95.0|-0.19|0.44||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.|||
1686843|NCT01159938|3102711|Superiority or Other||LS Mean Difference|-0.09||||0.584|2-Sided|95.0|-0.41|0.23||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.|||
1686844|NCT01159938|3102711|Superiority or Other||LS Mean Difference|0.42||||0.004|2-Sided|95.0|0.14|0.69||P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.|||
1686845|NCT01159938|3102711|Superiority or Other||LS Mean Difference|-0.02||||0.905|2-Sided|95.0|-0.31|0.27||P-value is for Least Square (LS) mean difference (high minus low postprandial glucose) in change in PAT at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.|||
1686846|NCT01159938|3102712|Superiority or Other||LS Mean Difference|-0.08||||0.954|2-Sided|95.0|-2.96|2.8||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.|||
1686847|NCT01159938|3102712|Superiority or Other||LS Mean Difference|-2.87||||0.065|2-Sided|95.0|-5.92|0.18||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.|||
1686848|NCT01159938|3102712|Superiority or Other||LS Mean Difference|2.04||||0.216|2-Sided|95.0|-1.25|5.33||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.|||
1686849|NCT01159938|3102712|Superiority or Other||LS Mean Difference|-1.84||||0.292|2-Sided|95.0|-5.33|1.64||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.|||
1686850|NCT01159938|3102712|Superiority or Other||LS Mean Difference|-0.58||||0.685|2-Sided|95.0|-3.46|2.3||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.|||
1686851|NCT01159938|3102712|Superiority or Other||LS Mean Difference|-2.19||||0.155|2-Sided|95.0|-5.25|0.87||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.|||
1686852|NCT01159938|3102712|Superiority or Other||LS Mean Difference|0.25||||0.859|2-Sided|95.0|-2.59|3.09||P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 60-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|The LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant.|||
1686853|NCT01159938|3102712|Superiority or Other||LS Mean Difference|-3.49||||0.024|2-Sided|95.0|-6.5|-0.48||P-value is for the Least Square (LS) mean difference (high minus low postprandial glucose) in change in PWA at 60-min post-breakfast. Significance was assessed at the 2-sided 5% level.|ANCOVA|LS mean was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.|||
1686854|NCT01159938|3102713|Superiority or Other||LS Mean Difference|-0.37||||0.298|2-Sided|95.0|-1.06|0.33||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686855|NCT01159938|3102713|Superiority or Other||LS Mean Difference|-0.43||||0.246|2-Sided|95.0|-1.16|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686856|NCT01159938|3102713|Superiority or Other||LS Mean Difference|-0.4||||0.122|2-Sided|95.0|-0.9|0.11||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686857|NCT01159938|3102713|Superiority or Other||LS Mean Difference|-0.79||||0.197|2-Sided|95.0|-2.01|0.43||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686858|NCT01159938|3102713|Superiority or Other||LS Mean Difference|-0.17||||0.784||95.0|-1.44|1.1||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686859|NCT01159938|3102713|Superiority or Other||LS Mean Difference|-0.48||||0.275|2-Sided|95.0|-1.36|0.4||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686860|NCT01159938|3102714|Superiority or Other||LS Mean Difference|0.26||||0.425|2-Sided|95.0|-0.39|0.9||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686861|NCT01159938|3102714|Superiority or Other||LS Mean Difference|-0.58||||0.091|2-Sided|95.0|-1.25|0.1||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686862|NCT01159938|3102714|Superiority or Other||LS Mean Difference|-0.16||||0.493|2-Sided|95.0|-0.63|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686863|NCT01159938|3102714|Superiority or Other||LS Mean Difference|-0.15||||0.792|2-Sided|95.0|-1.25|0.96||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686864|NCT01159938|3102714|Superiority or Other||LS Mean Difference|-0.44||||0.449|2-Sided|95.0|-1.6|0.72||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686865|NCT01159938|3102714|Superiority or Other||LS Mean Difference|-0.29||||0.466|2-Sided|95.0|-1.09|0.51||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686866|NCT01159938|3102715|Superiority or Other||LS Mean Difference|-0.2||||0.512|2-Sided|95.0|-0.83|0.42||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686867|NCT01159938|3102715|Superiority or Other||LS Mean Difference|-0.19||||0.553|2-Sided|95.0|-0.84|0.46||The p-value is for the LS mean difference (high minus low postprandial glucose) in PWV at 120 mins post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686868|NCT01159938|3102715|Superiority or Other||LS Mean Difference|-0.2||||0.378|2-Sided|95.0|-0.65|0.25||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686869|NCT01159938|3102715|Superiority or Other||LS Mean Difference|-0.18||||0.825|2-Sided|95.0|-1.76|1.41||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level.|ANCOVA||||
1686870|NCT01159938|3102715|Superiority or Other||LS Mean Difference|0.57||||0.479|2-Sided|95.0|-1.05|2.2||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level.|ANCOVA||||
1686871|NCT01159938|3102715|Superiority or Other||LS Mean Difference|0.2||||0.724|2-Sided|95.0|-0.94|1.34||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686872|NCT01159938|3102716|Superiority or Other||LS Mean Difference|-0.21||||0.413|2-Sided|95.0|-0.73|0.31||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686873|NCT01159938|3102716|Superiority or Other||LS Mean Difference|0.03||||0.916|2-Sided|95.0|-0.51|0.57||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686874|NCT01159938|3102716|Superiority or Other||LS Mean Difference|-0.09||||0.623|2-Sided|95.0|-0.47|0.28||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686875|NCT01159938|3102716|Superiority or Other||LS Mean Difference|-0.41||||0.513|2-Sided|95.0|-1.68|0.85||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686876|NCT01159938|3102716|Superiority or Other||LS Mean Difference|0.03||||0.957|2-Sided|95.0|-1.27|1.34||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686877|NCT01159938|3102716|Superiority or Other||LS Mean Difference|-0.19||||0.676|2-Sided|95.0|-1.1|0.72||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686878|NCT01159938|3102717|Superiority or Other||LS Mean Difference|-0.49||||0.167|2-Sided|95.0|-1.19|0.21||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at 2-sided 5% level.|ANCOVA||||
1686879|NCT01159938|3102717|Superiority or Other||LS Mean Difference|-0.2||||0.579|2-Sided|95.0|-0.94|0.53||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686880|NCT01159938|3102717|Superiority or Other||LS Mean Difference|-0.35||||0.177|2-Sided|95.0|-0.85|0.16||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in brachial arteries. Significance was assessed at 2-sided 5% level.|ANCOVA||||
1686881|NCT01159938|3102717|Superiority or Other||LS Mean Difference|0.27||||0.715|2-Sided|95.0|-1.2|1.73||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686882|NCT01159938|3102717|Superiority or Other||LS Mean Difference|0.25||||0.732|2-Sided|95.0|-1.23|1.73||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686883|NCT01159938|3102717|Superiority or Other||LS mean difference|0.26||||0.617|2-Sided|95.0|-0.78|1.3||P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 30-min pre-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level.|ANCOVA||||
1686884|NCT01159912|3102723|Superiority or Other||Median Difference (Final Values)|0.145||||0.011|2-Sided|95.0|0.033|0.257|||ANCOVA||||
1686885|NCT01159912|3102723|Superiority or Other||Mean Difference (Final Values)|0.146||||0.009|2-Sided|95.0|0.036|0.257|||ANCOVA||||
1686886|NCT01159600|3102737|Superiority or Other||Mean difference|-0.59|Standard Error of the Mean|0.07|<|0.0001|2-Sided|97.5|-0.74|-0.44||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.|
1686887|NCT01159600|3102737|Superiority or Other||Mean difference|-0.64|Standard Error of the Mean|0.07|<|0.0001|2-Sided|97.5|-0.79|-0.49||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.|
1686888|NCT01159600|3102737|Superiority or Other||Mean difference|-0.64|Standard Error of the Mean|0.07|<|0.0001|2-Sided|97.5|-0.79|-0.48||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 25mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.|
1686889|NCT01159600|3102737|Superiority or Other||Mean difference|-0.57|Standard Error of the Mean|0.07|<|0.0001|2-Sided|97.5|-0.72|-0.42||Each of the hypotheses (10mg vs placebo and 25mg vs. placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c as a linear covariate and baseline eGFR (renal function), geographical region and treatment as fixed effects.|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in HbA1c between Empagliflozin 10mg and placebo. The study consisted of two substudies as defined by the two background medications 'metformin' and 'metformin + SU'. Within each group of background medication, each of the two hypotheses (10mg vs placebo and 25mg vs. placebo) was tested in a two-sided test.|
1686890|NCT01159600|3102738|Superiority or Other||Mean difference|-13.06|Standard Error of the Mean|2.7|<|0.0001|2-Sided|97.5|-19.15|-6.98||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose|
1686891|NCT01159600|3102738|Superiority or Other||Mean difference|-10.02|Standard Error of the Mean|2.53|<|0.0001|2-Sided|97.5|-15.72|-4.32||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose|
1686892|NCT01159600|3102738|Superiority or Other||Mean difference|-12.37|Standard Error of the Mean|2.75|<|0.0001|2-Sided|97.5|-18.55|-6.19||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose|
1686893|NCT01159600|3102738|Superiority or Other||Mean difference|-7.65|Standard Error of the Mean|2.74|<|0.0055|2-Sided|97.5|-13.81|-1.48||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|Based on ANCOVA with baseline HbA1c and baseline MDG as linear covariates and baseline eGFR, geographical region and treatment as fixed effects.|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis (H0): No difference in change from baseline to week 24 in MDG between Empa 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons within each background therapy group. If for a specific dose H0 was rejected for the primary endpoint, the same dose was tested against placebo for change from baseline in body weight. If superiority over placebo was shown at this gate level, then testing proceeded to change from baseline in MDG with that dose|
1686979|NCT01156792|3103001|Superiority or Other||Mean Difference (Final Values)|1.014|||=|0|2-Sided|95.0|-3.64|5.67|||Mixed Models Analysis||||
1686980|NCT01156792|3103002|Superiority or Other||Mean Difference (Final Values)|-1.137|||=|0|2-Sided|95.0|-5.08|2.81|||Mixed Models Analysis||||
1690619|NCT01118455|3108497|Superiority or Other|||||||0.714|||||||t-test, 2 sided||||
1686894|NCT01159600|3102739|Superiority or Other||Mean difference|-1.99|Standard Error of the Mean|0.22|<|0.0001|2-Sided|97.5|-2.48|-1.5||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met+SU: empa 25mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.|
1686895|NCT01159600|3102739|Superiority or Other||Mean difference|-1.76|Standard Error of the Mean|0.22|<|0.0001|2-Sided|97.5|-2.25|-1.28||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met+SU: empa 10mg minus Met+SU: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.|
1686896|NCT01159600|3102739|Superiority or Other||Mean difference|-2.01|Standard Error of the Mean|0.24|<|0.0001|2-Sided|97.5|-2.56|-1.46||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met: empa 25mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 25mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.|
1686897|NCT01159600|3102739|Superiority or Other||Mean difference|-1.63|Standard Error of the Mean|0.24|<|0.0001|2-Sided|97.5|-2.17|-1.08||Each of the hypotheses (10mg vs placebo and 25mg vs placebo) were tested (two-sided test) at the significance level of 0.025.|ANCOVA|ANCOVA with baseline HbA1c and baseline body weight as linear covariates and baseline eGFR, geographical region and treatment as fixed effects|Difference calculated as Met: empa 10mg minus Met: placebo|Null hypothesis: No difference in change from baseline to week 24 in body weight between Empagliflozin 10mg and placebo. A hierarchical testing approach was applied to each of the two dose comparisons (10mg vs placebo and 25mg vs placebo) within each background therapy group (metformin and metformin + SU). If for a specific dose the null hypothesis was rejected for the primary endpoint, the same dose was tested against placebo for the change from baseline in body weight.|
1686898|NCT01159171|3102769|Superiority or Other|||||||0.0047||||||One-sided p-value|One sample exact binomial test||||
1686899|NCT01158820|3102815|Superiority||Median Difference (Final Values)|1.75||||0.01|2-Sided||||||Wilcoxon (Mann-Whitney)||units are mg|See reference for power analysis|
1686900|NCT01158820|3102816|Superiority||Mean Difference (Final Values)|43.75|||<|0.01|2-Sided||||||Wilcoxon (Mann-Whitney)||units are µg|See reference power analysis|
1686901|NCT01158820|3102817|Other|No data available for power analysis|Mean Difference (Net)|0.028|||<|0.0001|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1686902|NCT01158651|3102828|Superiority|The treatment regimen was considered promising for further study if after 48 weeks of treatment there was at least a 25% response rate compared to an expected response rate of 5% or less, which was considered evidence of an unpromising regimen. Assuming the true response rate is 5%, the binomial distribution was used to calculate Type I errors and power.|Proportion responding|0.682|||<|0.001|2-Sided|95.0|0.4872|0.8764|||Exact test||||
1686903|NCT01158573|3102829|Superiority or Other|||||||0.16|||||||ANOVA||||
1686904|NCT01158573|3102830|Superiority or Other|||||||0.725|||||||ANOVA||||
1686905|NCT01158573|3102831|Superiority or Other|||||||0.002|||||||ANOVA||||
1686906|NCT01158573|3102832|Superiority or Other||||||<|0.0001||||||Hypothesis that leptin levels in OA is not different from the other 3 groups.|ANOVA||||
1686907|NCT01158378|3102850|Superiority or Other|||||||0.0561|||||||one-sided z-test|||Superiority Test|
1686908|NCT01158378|3102850|Non-Inferiority or Equivalence|non-inferiority margin of 10%|||||<|0.0001|||||||one-sided z-test||||
1686909|NCT01158378|3102851|Superiority or Other|||||||0.0297|||||||one-sided z-test|||Superiority Test|
1686910|NCT01158378|3102851|Non-Inferiority or Equivalence|non-inferiority margin of 10%|||||<|0.0001|||||||one-sided z-test||||
1686911|NCT01158378|3102852|Non-Inferiority or Equivalence|non-inferiority margin of 10%||||||0.0049|||||||one-sided z-test||||
1686912|NCT01157234|3102915|Superiority or Other||Least Squares Mean Difference|2.74|Standard Error of the Mean|17.96|||2-Sided|99.17|-48.74|54.22|||||||
1686913|NCT01157234|3102916|Superiority or Other||Least Squares Mean Difference|1.39|Standard Error of the Mean|17.32|||2-Sided|99.17|-48.25|51.03|||||||
1686914|NCT01157234|3102917|Superiority or Other||Least Squares Mean Difference|68.19|Standard Error of the Mean|19.24|||2-Sided|99.17|13.02|123.36|||||||
1686915|NCT01157234|3102918|Superiority or Other||Least Squares Mean Difference|69.54|Standard Error of the Mean|19.83|||2-Sided|99.7|12.71|126.37|||||||
1686916|NCT01157234|3102919|Superiority or Other||Least Squares Mean Difference|11.94|||||2-Sided|95.0|0.48|23.4|||||||
1686917|NCT01157234|3102923|Superiority or Other||Least squares mean difference|1.23|Standard Error of the Mean|3.87|||2-Sided|95.0|-6.74|9.2|||||||
1686918|NCT01157234|3102924|Superiority or Other||Least Squares Mean Difference|8.27|||||2-Sided|95.0|-12.58|29.12|||||||
1686919|NCT01157234|3102925|Superiority or Other||Least Squares Mean Difference|28.73|||||2-Sided|95.0|1.93|55.53|||||||
1686981|NCT01156792|3103002|Superiority or Other||Mean Difference (Final Values)|0.2|||=|0|2-Sided|95.0|-3.84|4.24|||Mixed Models Analysis||||
1686920|NCT01157182|3102926|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.75|||||2-Sided|90.0|92.75|100.93|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686921|NCT01157182|3102927|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|96.01|||||2-Sided|90.0|92.14|100.04|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686922|NCT01157182|3102928|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.15|||||2-Sided|90.0|89.56|98.98|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686923|NCT01157182|3102929|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.63|||||2-Sided|90.0|88.1|103.81|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686924|NCT01157182|3102930|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.47|||||2-Sided|90.0|88.37|103.14|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686925|NCT01157182|3102931|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|91.73|||||2-Sided|90.0|84.46|99.62|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686926|NCT01157182|3102932|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.22|||||2-Sided|90.0|93.62|100.96|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686927|NCT01157182|3102933|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.99|||||2-Sided|90.0|92.73|99.36|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686928|NCT01157182|3102934|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.19|||||2-Sided|90.0|89.78|98.81|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686929|NCT01157182|3102935|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.48|||||2-Sided|90.0|90.7|104.76|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686930|NCT01157182|3102936|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.11|||||2-Sided|90.0|89.04|99.47|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686931|NCT01157182|3102937|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|91.21|||||2-Sided|90.0|84.62|98.31|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686982|NCT01156792|3103002|Superiority or Other||Mean Difference (Final Values)|3.669|||=|0|2-Sided|95.0|-0.54|7.87|||Mixed Models Analysis||||
1686932|NCT01157182|3102938|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.73|||||2-Sided|90.0|92.68|98.88|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686933|NCT01157182|3102939|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.67|||||2-Sided|90.0|92.68|98.77|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686934|NCT01157182|3102940|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.41|||||2-Sided|90.0|88.65|96.33|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686935|NCT01157182|3102941|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.71|||||2-Sided|90.0|92.62|98.91|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1686936|NCT01157182|3102942|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.66|||||2-Sided|90.0|92.6|98.81|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1686937|NCT01157182|3102943|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|92.51|||||2-Sided|90.0|88.64|96.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1686938|NCT01157182|3102944|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.73|||||2-Sided|90.0|95.33|102.26|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1686939|NCT01157182|3102945|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.4|||||2-Sided|90.0|95.15|101.76|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1686940|NCT01157182|3102946|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.94|||||2-Sided|90.0|97.63|108.55|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1686941|NCT01157169|3102947|Non-Inferiority or Equivalence (legacy)|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|95.06|||||2-Sided|90.0|86.56|104.39|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686942|NCT01157169|3102948|Non-Inferiority or Equivalence (legacy)|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|94.19|||||2-Sided|90.0|87.44|101.46|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686983|NCT01156792|3103002|Superiority or Other||Mean Difference (Final Values)|0.575|||=|0|2-Sided|95.0|-3.65|4.8|||Mixed Models Analysis||||
1688207|NCT01139762|3105413|Superiority or Other|||||||0.031|||||||Van Elteren test|Van Elteren test was stratified by region.|||
1686943|NCT01157169|3102949|Non-Inferiority or Equivalence (legacy)|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|93.28|||||2-Sided|90.0|85.37|101.93|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1686944|NCT01157169|3102950|Non-Inferiority or Equivalence (legacy)|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.97|||||2-Sided|90.0|97.18|111.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1686945|NCT01157169|3102951|Non-Inferiority or Equivalence (legacy)|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.91|||||2-Sided|90.0|99.74|112.45|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1686946|NCT01157169|3102952|Non-Inferiority or Equivalence (legacy)|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|110.49|||||2-Sided|90.0|101.67|120.07|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1686947|NCT01157117|3102966|Superiority or Other||Risk Difference (RD)|12.0||||0.42|2-Sided|95.0|-13.4|37.3||No adjustments were made to the p-value.|Fisher Exact|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 10,000 mg of milk protein followed by an open feeding of milk was compared using Fisher’s Exact test with the null hypothesis that there was no difference between treatment groups.|
1686948|NCT01157078|3102967|Superiority or Other||LS mean|1.6|Standard Error of the Mean|2.34||0.484|2-Sided|95.0|-2.98|6.26||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1686949|NCT01157078|3102967|Superiority or Other||LS mean|0.024|Standard Error of the Mean|0.0226||0.298|2-Sided|95.0|-0.0209|0.068||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1686950|NCT01157078|3102968|Superiority or Other||LS Mean|-1.1|Standard Error of the Mean|1.61||0.515|2-Sided|95.0|-4.22|2.12|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1686951|NCT01157078|3102969|Superiority or Other||LS mean|0.1|Standard Error of the Mean|0.1||0.178|2-Sided|95.0|-0.06|0.33|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.|
1686952|NCT01157078|3102970|Superiority or Other||LS mean|-0.1|Standard Error of the Mean|0.12||0.446|2-Sided|95.0|-0.31|0.14|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1686953|NCT01157078|3102971|Superiority or Other||LS mean|0.82|Standard Error of the Mean|1.789||0.646|2-Sided|95.0|-2.699|4.346|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1686954|NCT01157078|3102972|Superiority or Other||LS mean|-0.1|Standard Error of the Mean|0.26||0.755|2-Sided|95.0|-0.6|0.44|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.|
1686955|NCT01157078|3102973|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.29||0.931|2-Sided|95.0|-0.59|0.54|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1686956|NCT01157078|3102974|Superiority or Other||LS mean|-0.4|Standard Error of the Mean|0.3||0.214|2-Sided|95.0|-0.96|0.22||Analysis for change in SDS work/school domain score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1686984|NCT01156792|3103003|Superiority or Other||Mean Difference (Final Values)|1.521|||=|0|2-Sided|95.0|-2.59|5.63|||Mixed Models Analysis||||
1686985|NCT01156792|3103003|Superiority or Other||Mean Difference (Final Values)|2.331|||=|0|2-Sided|95.0|-1.88|6.55|||Mixed Models Analysis||||
1686986|NCT01156792|3103003|Superiority or Other||Mean Difference (Final Values)|2.147|||=|0|2-Sided|95.0|-2.2|6.49|||Mixed Models Analysis||||
1686957|NCT01157078|3102975|Superiority or Other||LS mean|-0.62|Standard Error of the Mean|0.771||0.424|2-Sided|95.0|-2.134|0.901||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1686958|NCT01157078|3102976|Superiority or Other||LS mean|-0.7|Standard Error of the Mean|0.97||0.501|2-Sided|95.0|-2.56|1.25|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.|
1686959|NCT01157078|3102977|Superiority or Other||LS mean|-0.7|Standard Error of the Mean|0.9||0.435|2-Sided|95.0|-2.47|1.07|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1686960|NCT01157078|3102978|Superiority or Other||LS mean|0.7|Standard Error of the Mean|0.78||0.373|2-Sided|95.0|-0.84|2.24|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1686961|NCT01157078|3102979|Superiority or Other||LS mean|0.2|Standard Error of the Mean|0.55||0.768|2-Sided|95.0|-0.91|1.23||Analysis for change in MADRS total score from randomization to Week 9.|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1686962|NCT01157078|3102980|Superiority or Other||Odds Ratio (OR)|1.2|Standard Error of the Mean|0.28||0.44|2-Sided|95.0|0.75|1.91|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.|
1686963|NCT01157078|3102981|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.14||0.803||95.0|-0.31|0.24|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1686964|NCT01157078|3102982|Superiority or Other||LS mean|-0.5|Standard Error of the Mean|0.82||0.552|2-Sided|95.0|-2.1|1.12|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1686965|NCT01157078|3102983|Superiority or Other||Odds Ratio (OR)|1.77|Standard Error of the Mean|0.79||0.201|2-Sided|95.0|0.74|4.24|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1686966|NCT01157078|3102984|Superiority or Other||Odds Ratio (OR)|1.44|Standard Error of the Mean|0.52||0.313|2-Sided|95.0|0.71|2.94|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1686967|NCT01157078|3102985|Superiority or Other||Odds Ratio (OR)|1.75|Standard Error of the Mean|0.96||0.307|2-Sided|95.0|0.6|5.14|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1686968|NCT01157078|3102986|Superiority or Other||Odds Ratio (OR)|1.52|Standard Error of the Mean|0.42||0.13|2-Sided|95.0|0.88|2.61|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1686969|NCT01157078|3102987|Superiority or Other||Odds Ratio (OR)|1.2|Standard Error of the Mean|0.29||0.444|2-Sided|95.0|0.75|1.92|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1686970|NCT01157078|3102988|Superiority or Other||LS mean|-1.0|Standard Error of the Mean|1.08||0.349|2-Sided|95.0|-3.14|1.11||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1686971|NCT01156805|3102999|Superiority|||||||0.05|||||||Mixed Models Analysis|Mixed-effects linear regression, adjusted for clustering within schools and children to assess the effect of intervention on changes in BMI over time|||
1686972|NCT01156792|3103000|Superiority or Other||||||=|0|||||||Fisher Exact||||
1686973|NCT01156792|3103000|Superiority or Other||||||=|0|||||||Fisher Exact||||
1686974|NCT01156792|3103000|Superiority or Other||||||=|0|||||||Fisher Exact||||
1686975|NCT01156792|3103000|Superiority or Other||||||=|0|||||||Fisher Exact||||
1686976|NCT01156792|3103001|Superiority or Other||Mean Difference (Final Values)|1.26|||=|0|2-Sided|95.0|-2.94|5.46|||Mixed Models Analysis||||
1686977|NCT01156792|3103001|Superiority or Other||Mean Difference (Final Values)|0.496|||=|0|2-Sided|95.0|-3.83|4.82|||Mixed Models Analysis||||
1686978|NCT01156792|3103001|Superiority or Other||Mean Difference (Final Values)|3.349|||=|0|2-Sided|95.0|-1.29|7.98|||Mixed Models Analysis||||
1690620|NCT01118455|3108498|Superiority or Other|||||||0.142|||||||t-test, 2 sided||||
1686987|NCT01156792|3103003|Superiority or Other||Mean Difference (Final Values)|1.992|||=|0|2-Sided|95.0|-2.35|6.33|||Mixed Models Analysis||||
1686988|NCT01156792|3103004|Superiority or Other||Mean Difference (Final Values)|1.26|||=|0|2-Sided|95.0|-2.94|5.46|||Mixed Models Analysis||||
1686989|NCT01156792|3103004|Superiority or Other||Mean Difference (Final Values)|0.496|||=|0|2-Sided|95.0|-3.83|4.82|||Mixed Models Analysis||||
1686990|NCT01156792|3103004|Superiority or Other||Mean Difference (Final Values)|3.349|||=|0|2-Sided|95.0|-1.29|7.98|||Mixed Models Analysis||||
1686991|NCT01156792|3103004|Superiority or Other||Mean Difference (Final Values)|1.014|||=|0|2-Sided|95.0|-3.64|5.67|||Mixed Models Analysis||||
1686992|NCT01156792|3103005|Superiority or Other||Mean Difference (Final Values)|4.602|||=|0|2-Sided|95.0|0.06|9.14|||Mixed Models Analysis||||
1686993|NCT01156792|3103005|Superiority or Other||Mean Difference (Final Values)|4.036|||=|0|2-Sided|95.0|-0.63|8.7|||Mixed Models Analysis||||
1686994|NCT01156792|3103005|Superiority or Other||Mean Difference (Final Values)|5.3|||=|0|2-Sided|95.0|0.38|10.22|||Mixed Models Analysis||||
1686995|NCT01156792|3103005|Superiority or Other||Mean Difference (Final Values)|2.666|||=|0|2-Sided|95.0|-2.24|7.57|||Mixed Models Analysis||||
1686996|NCT01156792|3103006|Superiority or Other||Mean Difference (Final Values)|-0.084|||=|0|2-Sided|95.0|-0.26|0.1|||Mixed Models Analysis||||
1686997|NCT01156792|3103006|Superiority or Other||Mean Difference (Final Values)|-0.076|||=|0|2-Sided|95.0|-0.26|0.11|||Mixed Models Analysis||||
1686998|NCT01156792|3103006|Superiority or Other||Mean Difference (Final Values)|-0.133|||=|0|2-Sided|95.0|-0.34|0.07|||Mixed Models Analysis||||
1686999|NCT01156792|3103006|Superiority or Other||Mean Difference (Final Values)|-0.025|||=|0|2-Sided|95.0|-0.23|0.18|||Mixed Models Analysis||||
1687000|NCT01156792|3103007|Superiority or Other||Mean Difference (Final Values)|-0.011|||=|0|2-Sided|95.0|-0.17|0.15|||Mixed Models Analysis||||
1687001|NCT01156792|3103007|Superiority or Other||Mean Difference (Final Values)|-0.038|||=|0|2-Sided|95.0|-0.2|0.12|||Mixed Models Analysis||||
1687002|NCT01156792|3103007|Superiority or Other||Mean Difference (Final Values)|-0.108|||=|0|2-Sided|95.0|-0.28|0.06|||Mixed Models Analysis||||
1687003|NCT01156792|3103007|Superiority or Other||Mean Difference (Final Values)|-0.005|||=|0|2-Sided|95.0|-0.18|0.17|||Mixed Models Analysis||||
1687004|NCT01156792|3103008|Superiority or Other||Mean Difference (Final Values)|-0.364|||||2-Sided|95.0|-6.22|5.5|||||||
1687005|NCT01156792|3103008|Superiority or Other||Mean Difference (Final Values)|-4.154|||||2-Sided|95.0|-9.36|1.06|||||||
1687006|NCT01156792|3103009|Superiority or Other||Mean Difference (Final Values)|10.292|||=|0|2-Sided|95.0|4.21|16.38|||Mixed Models Analysis||||
1687007|NCT01156792|3103009|Superiority or Other||Mean Difference (Final Values)|4.822|||=|0|2-Sided|95.0|-1.37|11.02|||Mixed Models Analysis||||
1687008|NCT01156792|3103009|Superiority or Other||Mean Difference (Final Values)|5.1|||=|0|2-Sided|95.0|-0.47|10.67|||Mixed Models Analysis||||
1687009|NCT01156792|3103009|Superiority or Other||Mean Difference (Final Values)|1.651|||=|0|2-Sided|95.0|-3.97|7.27|||Mixed Models Analysis||||
1687010|NCT01156792|3103010|Superiority or Other||Mean Difference (Final Values)|12.14|||<|0.001|2-Sided|95.0|5.93|18.35|||Mixed Models Analysis||||
1687011|NCT01156792|3103010|Superiority or Other||Mean Difference (Final Values)|4.983|||=|0|2-Sided|95.0|-1.35|11.32|||Mixed Models Analysis||||
1687012|NCT01156792|3103010|Superiority or Other||Mean Difference (Final Values)|5.771|||=|0|2-Sided|95.0|0.03|11.51|||Mixed Models Analysis||||
1687013|NCT01156792|3103010|Superiority or Other||Mean Difference (Final Values)|0.946|||=|0|2-Sided|95.0|-4.91|6.81|||Mixed Models Analysis||||
1687014|NCT01156792|3103011|Superiority or Other||Mean Difference (Final Values)|0.074|||=|0|2-Sided|95.0|0.03|0.12|||Mixed Models Analysis||||
1687015|NCT01156792|3103011|Superiority or Other||Mean Difference (Final Values)|0.056|||=|0|2-Sided|95.0|0.01|0.1|||Mixed Models Analysis||||
1687016|NCT01156792|3103011|Superiority or Other||Mean Difference (Final Values)|0.042|||=|0|2-Sided|95.0|0.0|0.09|||Mixed Models Analysis||||
1687017|NCT01156792|3103011|Superiority or Other||Mean Difference (Final Values)|0.026|||=|0|2-Sided|95.0|-0.02|0.07|||Mixed Models Analysis||||
1687018|NCT01156701|3103020|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.99|1.0|||||Protective effect of zanamivir on susceptible risk||
1687019|NCT01156701|3103020|Superiority or Other||Risk Ratio (RR)|1.01|||||2-Sided|95.0|0.98|1.04|||||Risk in cohort 1 minus risk in cohort 2||
1687020|NCT01156701|3103020|Superiority or Other||Risk Ratio (RR)|0.99|||||2-Sided|95.0|0.98|1.0|||||Direct effect of zanamivir prophylaxis when index is treated||
1687021|NCT01156701|3103020|Superiority or Other||Risk Ratio (RR)|0.99|||||2-Sided|95.0|0.98|1.0|||||Total effect of zanamivir prophylaxis||
1687022|NCT01156701|3103020|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.97|1.03|||||Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis||
1687023|NCT01156701|3103020|Superiority or Other||Risk Difference (RD)|-0.01|||||2-Sided|95.0|-0.58|0.59|||||Protective effect of zanamivir on susceptible risk||
1687024|NCT01156701|3103020|Superiority or Other||Risk Difference (RD)|0.93|||||2-Sided|95.0|-2.29|4.14|||||Risk in cohort 1 minus risk in cohort 2||
1687025|NCT01156701|3103020|Superiority or Other||Risk Difference (RD)|-1.08|||||2-Sided|95.0|-2.51|0.35|||||Direct effect of zanamivir prophylaxis when index is treated||
1687026|NCT01156701|3103020|Superiority or Other||Risk Difference (RD)|-1.07|||||2-Sided|95.0|-2.39|0.25|||||Total effect of zanamivir prophylaxis||
1687027|NCT01156701|3103020|Superiority or Other||Risk Difference (RD)|-0.14|||||2-Sided|95.0|-3.08|2.79|||||Direct effect of Zanamivir prophylaxis on risk of any respiratory diagnosis||
1687028|NCT01156701|3103021|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk||
1687029|NCT01156701|3103021|Superiority or Other||Risk Ratio (RR)|1.02|||||2-Sided|95.0|0.99|1.04|||||Risk in cohort 1 minus risk in cohort 2||
1690621|NCT01118455|3108498|Superiority or Other|||||||0.799|||||||t-test, 2 sided||||
1687030|NCT01156701|3103021|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.99|1.01|||||Direct effect of zanamivir prophylaxis when index is treated||
1687031|NCT01156701|3103021|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis||
1687032|NCT01156701|3103021|Superiority or Other||Risk Ratio (RR)|1.01|||||2-Sided|95.0|0.99|1.03|||||Direct effect of Zanamivir prophylaxis on bronchitis risk||
1687033|NCT01156701|3103021|Superiority or Other||Risk Difference (RD)|-0.16|||||2-Sided|95.0|-0.44|0.12|||||Protective effect of zanamivir on susceptible risk||
1687034|NCT01156701|3103021|Superiority or Other||Risk Difference (RD)|1.53|||||2-Sided|95.0|-0.7|3.76|||||Risk in cohort 1 minus risk in cohort 2||
1687035|NCT01156701|3103021|Superiority or Other||Risk Difference (RD)|-0.09|||||2-Sided|95.0|-0.85|0.67|||||Direct effect of zanamivir prophylaxis when index is treated||
1687036|NCT01156701|3103021|Superiority or Other||Risk Difference (RD)|-0.24|||||2-Sided|95.0|-0.98|0.47|||||Total effect of zanamivir prophylaxis||
1687037|NCT01156701|3103021|Superiority or Other||Risk Difference (RD)|1.28|||||2-Sided|95.0|-0.83|3.4|||||Direct effect of Zanamivir prophylaxis on bronchitis risk||
1687038|NCT01156701|3103022|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk||
1687039|NCT01156701|3103022|Superiority or Other||Risk Ratio (RR)|1.01|||||2-Sided|95.0|1.0|1.02|||||Risk in cohort 1 minus risk in cohort 2||
1687040|NCT01156701|3103022|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|1.0|1.0|||||Direct effect of zanamivir prophylaxis when index is treated||
1687041|NCT01156701|3103022|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|1.0|1.0|||||Total effect of zanamivir prophylaxis||
1687042|NCT01156701|3103022|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.99|1.02|||||Direct effect of Zanamivir prophylaxis on pneumonia risk||
1687043|NCT01156701|3103022|Superiority or Other||Risk Difference (RD)|-0.1|||||2-Sided|95.0|-0.22|0.02|||||Protective effect of zanamivir on susceptible risk||
1687044|NCT01156701|3103022|Superiority or Other||Risk Difference (RD)|0.72|||||2-Sided|95.0|-0.38|1.81|||||Risk in cohort 1 minus risk in cohort 2||
1687045|NCT01156701|3103022|Superiority or Other||Risk Difference (RD)|-0.15|||||2-Sided|95.0|-0.39|0.09|||||Direct effect of zanamivir prophylaxis when index is treated||
1687046|NCT01156701|3103022|Superiority or Other||Risk Difference (RD)|-0.25|||||2-Sided|95.0|-0.45|-0.04|||||Total effect of zanamivir prophylaxis||
1687047|NCT01156701|3103022|Superiority or Other||Risk Difference (RD)|0.46|||||2-Sided|95.0|-0.61|1.54|||||Direct effect of Zanamivir prophylaxis on pneumonia risk||
1687048|NCT01156701|3103023|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|1.0|1.0|||||Protective effect of zanamivir on susceptible risk||
1687049|NCT01156701|3103023|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.99|1.01|||||Risk in cohort 1 minus risk in cohort 2||
1687050|NCT01156701|3103023|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.99|1.0|||||Direct effect of zanamivir prophylaxis when index is treated||
1687051|NCT01156701|3103023|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis||
1687052|NCT01156701|3103023|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.99|1.0|||||Direct effect of Zanamivir prophylaxis on asthma risk||
1687053|NCT01156701|3103023|Superiority or Other||Risk Difference (RD)|-0.1|||||2-Sided|95.0|-0.31|0.11|||||Protective effect of zanamivir on susceptible risk||
1687054|NCT01156701|3103023|Superiority or Other||Risk Difference (RD)|-0.02|||||2-Sided|95.0|-0.89|0.85|||||Risk in cohort 1 minus risk in cohort 2||
1687055|NCT01156701|3103023|Superiority or Other||Risk Difference (RD)|-0.28|||||2-Sided|95.0|-0.75|0.18|||||Direct effect of zanamivir prophylaxis when index is treated||
1687056|NCT01156701|3103023|Superiority or Other||Risk Difference (RD)|-0.38|||||2-Sided|95.0|-0.8|0.03|||||Total effect of zanamivir prophylaxis||
1687057|NCT01156701|3103023|Superiority or Other||Risk Difference (RD)|-0.4|||||2-Sided|95.0|-1.17|0.36|||||Direct effect of Zanamivir prophylaxis on asthma risk||
1687058|NCT01156701|3103024|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.99|1.0|||||Protective effect of zanamivir on susceptible risk||
1687059|NCT01156701|3103024|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.99|1.02|||||Risk in cohort 1 minus risk in cohort 2||
1687060|NCT01156701|3103024|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.99|1.0|||||Direct effect of zanamivir prophylaxis when index is treated||
1687061|NCT01156701|3103024|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.99|1.0|||||Total effect of zanamivir prophylaxis||
1687062|NCT01156701|3103024|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.99|1.01|||||Direct effect of Zanamivir prophylaxis on influenza risk||
1687063|NCT01156701|3103024|Superiority or Other||Risk Difference (RD)|-0.24|||||2-Sided|95.0|-0.51|0.03|||||Protective effect of zanamivir on susceptible risk||
1687064|NCT01156701|3103024|Superiority or Other||Risk Difference (RD)|0.23|||||2-Sided|95.0|-1.15|1.62|||||Risk in cohort 1 minus risk in cohort 2||
1687065|NCT01156701|3103024|Superiority or Other||Risk Difference (RD)|-0.14|||||2-Sided|95.0|-0.75|0.47|||||Direct effect of zanamivir prophylaxis when index is treated||
1687066|NCT01156701|3103024|Superiority or Other||Risk Difference (RD)|-0.38|||||2-Sided|95.0|-0.93|0.17|||||Total effect of zanamivir prophylaxis||
1687067|NCT01156701|3103024|Superiority or Other||Risk Difference (RD)|-0.15|||||2-Sided|95.0|-1.42|1.12|||||Direct effect of Zanamivir prophylaxis on influenza risk||
1687068|NCT01156597|3103036|Superiority or Other|||||||0.05|||||||ANOVA|The percent change of HDL and triglycerides from baseline between groups was evaluated by ANOVA using baseline, 12 week and 24 week values|||
1687069|NCT01156363|3103132|Superiority or Other|||||||0.0196|||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.|
1687070|NCT01156363|3103132|Superiority or Other|||||||0.1608|||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.|
1687071|NCT01156363|3103132|Superiority or Other|||||||0.0677|||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.|
1687072|NCT01156363|3103132|Superiority or Other|||||||0.0017|||||||Paired t-test|||Change from baseline to Month 8: analysis was performed using paired t-test.|
1687073|NCT01156363|3103132|Superiority or Other|||||||0.141|||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.|
1687074|NCT01156363|3103132|Superiority or Other|||||||0.3374|||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.|
1687075|NCT01156363|3103132|Superiority or Other|||||||0.3057|||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.|
1687076|NCT01156363|3103132|Superiority or Other|||||||0.0039|||||||Paired t-test|||Change from baseline to Month 7: analysis was performed using paired t-test.|
1687077|NCT01156363|3103132|Superiority or Other|||||||0.7853|||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.|
1687078|NCT01156363|3103132|Superiority or Other|||||||0.0081|||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.|
1687079|NCT01156363|3103132|Superiority or Other|||||||0.0066|||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.|
1687080|NCT01156363|3103132|Superiority or Other|||||||0.2796|||||||Paired t-test|||Change from baseline to Month 6: analysis was performed using paired t-test.|
1687081|NCT01156363|3103132|Superiority or Other|||||||0.3724|||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.|
1687082|NCT01156363|3103132|Superiority or Other|||||||0.005|||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.|
1687083|NCT01156363|3103132|Superiority or Other|||||||0.0177|||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.|
1687084|NCT01156363|3103132|Superiority or Other|||||||0.0907|||||||Paired t-test|||Change from baseline to Month 5: analysis was performed using paired t-test.|
1687085|NCT01156363|3103132|Superiority or Other|||||||0.8206|||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.|
1687086|NCT01156363|3103132|Superiority or Other|||||||0.0209|||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.|
1687087|NCT01156363|3103132|Superiority or Other|||||||0.0253|||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.|
1687088|NCT01156363|3103132|Superiority or Other|||||||0.3766|||||||Paired t-test|||Change from baseline to Month 4: analysis was performed using paired t-test.|
1687089|NCT01156363|3103132|Superiority or Other|||||||0.0905|||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.|
1687090|NCT01156363|3103132|Superiority or Other||||||<|0.001|||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.|
1687091|NCT01156363|3103132|Superiority or Other||||||<|0.1749|||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.|
1687092|NCT01156363|3103132|Superiority or Other||||||<|0.3917|||||||Paired t-test|||Change from baseline to Month 3: analysis was performed using paired t-test.|
1687093|NCT01156363|3103132|Superiority or Other||||||<|0.7816|||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.|
1687094|NCT01156363|3103132|Superiority or Other||||||<|0.1634|||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.|
1687095|NCT01156363|3103132|Superiority or Other||||||<|0.2384|||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.|
1687096|NCT01156363|3103132|Superiority or Other||||||<|0.8235|||||||Paired t-test|||Change from baseline to Month 2: analysis was performed using paired t-test.|
1687097|NCT01156363|3103132|Superiority or Other||||||<|0.5684|||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.|
1687098|NCT01156363|3103132|Superiority or Other||||||<|0.5703|||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.|
1687099|NCT01156363|3103132|Superiority or Other||||||<|0.5737|||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.|
1687100|NCT01156363|3103132|Superiority or Other||||||<|0.9825|||||||Paired t-test|||Change from baseline to Month 1: analysis was performed using paired t-test.|
1687101|NCT01156311|3103136|Superiority or Other||Median Difference (Final Values)|-0.5||||0.0339|2-Sided|95.0|-1.25|0.0|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.|
1687102|NCT01156311|3103136|Superiority or Other||Median Difference (Final Values)|-0.5||||0.001|2-Sided|95.0|-1.5|-0.25|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -4, and 0 to average of Weeks 20, 24 MRI scans.|
1687103|NCT01156311|3103137|Superiority or Other||Median Difference (Final Values)|-1.17||||0.0124|2-Sided|95.0|-1.83|-0.33|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.|
1687104|NCT01156311|3103137|Superiority or Other||Median Difference (Final Values)|-0.92|||<|0.0001|2-Sided|95.0|-1.17|-0.33|||Wilcoxon signed rank test||based on Hodges-Lehmann estimate|Change from average of Weeks -8, -4, and 0 to average of Weeks 16, 20, 24 MRI scans.|
1687105|NCT01156142|3103143|Superiority or Other|||||||0.0018|||||||Chi-squared||||
1687106|NCT01156142|3103144|Superiority or Other|||||||0.6989|||||||Chi-squared|||At 4 hours after initial mouthwash|
1687107|NCT01156142|3103144|Superiority or Other|||||||0.1392|||||||Chi-squared|||At 2 hours after initial mouthwash|
1687108|NCT01156142|3103145|Superiority or Other||Mean Difference (Final Values)|1.7||||0.0297|2-Sided|95.0|-1.2|4.6|||Wilcoxon (Mann-Whitney)||||
1687109|NCT01156142|3103146|Superiority or Other||Mean Difference (Final Values)|5.6||||0.001|2-Sided|95.0|2.9|8.3|||Wilcoxon (Mann-Whitney)||||
1687110|NCT01156142|3103147|Superiority or Other||Mean Difference (Final Values)|2.6||||0.0018|2-Sided|95.0|0.1|5.1|||Wilcoxon (Mann-Whitney)||||
1687111|NCT01156142|3103148|Superiority or Other||Mean Difference (Final Values)|-4.4|||<|0.001|2-Sided|95.0|-6.7|-2.1|||Wilcoxon (Mann-Whitney)||||
1687112|NCT01156116|3103149|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.|||
1687113|NCT01156116|3103150|Superiority or Other|||||||0.009|||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.|||
1687114|NCT01156116|3103151|Superiority or Other|||||||0.04|||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.|||
1687115|NCT01156116|3103152|Superiority or Other|||||||0.03|||||||Mixed Models Analysis|Analyses were adjusted for age, body mass index, and ethnicity-based diabetes risk.|||
1687116|NCT01156051|3103153|Superiority or Other|||||||0.059|||||||ANOVA|||Null hypothesis: no difference in total sleep time (TST) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.|
1687117|NCT01156051|3103154|Superiority or Other|||||||0.392|||||||ANOVA|||Null hypothesis: no difference in latency to persistent sleep (LPS) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.|
1687118|NCT01156051|3103155|Superiority or Other||||||<|0.001|||||||ANOVA|||Null hypothesis: no difference in ADHD Rating Scales - IV total scores from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.|
1687119|NCT01156051|3103156|Superiority or Other|||||||0.005|||||||ANOVA|||Null hypothesis: no difference in total sleep time (TST) from baseline to termination. ANOVA single measure, two-tailed, Type II analysis was completed using SPSS.|
1687120|NCT01155726|3103188|Superiority or Other||Mean Difference (Final Values)|0.4|||||2-Sided|95.0|-1.1|1.9||||||Partial masked minus masked|
1687121|NCT01155726|3103188|Superiority or Other||Mean Difference (Final Values)|-0.1|||||2-Sided|95.0|-2.9|2.7||||||Partial masked minus masked|
1687122|NCT01155726|3103188|Superiority or Other||Mean Difference (Final Values)|-0.4|||||2-Sided|95.0|-1.9|1.1||||||Partial masked minus masked|
1687123|NCT01155726|3103188|Superiority or Other||Mean Difference (Final Values)|-1.1|||||2-Sided|95.0|-3.3|1.2||||||Partial masked minus masked|
1687124|NCT01155726|3103188|Superiority or Other||Mean Difference (Final Values)|1.9|||||2-Sided|95.0|0.2|3.5||||||Unmasked minus masked|
1687125|NCT01155726|3103188|Superiority or Other||Mean Difference (Final Values)|1.1|||||2-Sided|95.0|-0.1|2.2||||||Unmasked minus masked|
1687126|NCT01155726|3103188|Superiority or Other||Mean Difference (Final Values)|0.5|||||2-Sided|95.0|-1.5|2.5||||||Unmasked minus masked|
1687127|NCT01155726|3103188|Superiority or Other||Mean Difference (Final Values)|-0.4|||||2-Sided|95.0|-2.2|1.4||||||Unmasked minus masked|
1687128|NCT01155570|3103211|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 24|
1687129|NCT01155570|3103212|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 16|
1687130|NCT01155570|3103213|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 4|
1687131|NCT01155570|3103214|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 24|
1687132|NCT01155570|3103215|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 16|
1687133|NCT01155570|3103216|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 4|
1687134|NCT01155570|3103217|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 24|
1687135|NCT01155570|3103219|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 16|
1687136|NCT01155570|3103220|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 4|
1687137|NCT01155570|3103221|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 24|
1687138|NCT01155570|3103222|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 16|
1687139|NCT01155570|3103227|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 24|
1687140|NCT01155570|3103228|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 16|
1687141|NCT01155570|3103229|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 24|
1687142|NCT01155570|3103230|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 16|
1687143|NCT01155570|3103231|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 8|
1687144|NCT01155570|3103232|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||comparison versus Baseline at Week 4|
1687145|NCT01155479|3103242|Superiority or Other||Difference in Estimated Means|0.1||||0.6657|2-Sided|95.0|-0.45|0.7|||constrained longitudinal analysis|||Rasagiline (Part 1) vs Placebo (Part 1)|
1687146|NCT01155479|3103242|Superiority or Other||Difference in Estimated Means|0.2||||0.5756|2-Sided|95.0|-0.42|0.75|||constrained longitudinal analysis|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)|
1687147|NCT01155479|3103242|Superiority or Other||Difference in Estimated Means|0.5||||0.1093|2-Sided|95.0|-0.11|1.04|||constrained longitudinal analysis|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)|
1687148|NCT01155479|3103242|Superiority or Other||Difference in Estimated Means|0.7||||0.0235|2-Sided|95.0|0.09|1.27|||constrained longitudinal analysis|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)|
1687149|NCT01155479|3103243|Superiority or Other||Difference vs Placebo (%)|-2.3||||0.6827|2-Sided|95.0|-13.9|9.24||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Rasagiline (Part 1) vs Placebo (Part 1)|
1687150|NCT01155479|3103243|Superiority or Other||Difference vs Placebo (%)|-3.7||||0.4823|2-Sided|95.0|-15.2|7.99||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)|
1687151|NCT01155479|3103243|Superiority or Other||Difference vs Placebo (%)|-6.3||||0.2735|2-Sided|95.0|-17.6|5.05||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)|
1687152|NCT01155479|3103243|Superiority or Other||Difference vs Placebo (%)|-9.7||||0.0785|2-Sided|95.0|-21.0|1.82||p-value is for the estimated Odds Ratio based on a generalized linear mixed model with baseline UPDRS2+3 as a covariate and treatment-by-time interaction as fixed effect and participant as random effect.|generalized linear mixed model|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)|
1687153|NCT01155479|3103244|Superiority or Other||Difference in Estimated Means|0.3||||0.6923|2-Sided|95.0|-1.35|2.03|||constrained longitudinal analysis|||Rasagiline (Part 1) vs Placebo (Part 1)|
1687154|NCT01155479|3103244|Superiority or Other||Difference in Estimated Means|0.4||||0.6378|2-Sided|95.0|-1.29|2.11|||constrained longitudinal analysis|||Preladenant 10 mg (Part 1) vs Placebo (Part 1)|
1687155|NCT01155479|3103244|Superiority or Other||Difference in Estimated Means|1.3||||0.1382|2-Sided|95.0|-0.41|2.94|||constrained longitudinal analysis|||Preladenant 5 mg (Part 1) vs Placebo (Part 1)|
1687156|NCT01155479|3103244|Superiority or Other||Difference in Estimated Means|2.6||||0.0033|2-Sided|95.0|0.86|4.3|||constrained longitudinal analysis|||Preladenant 2 mg (Part 1) vs Placebo (Part 1)|
1687157|NCT01155466|3103245|Superiority or Other||Mean Difference (Final Values)|0.2||||0.6405|2-Sided|95.0|-0.49|0.8|||Mixed Models Analysis||"The estimated parameter is the difference in the estimated change from baseline in on time without troublesome dyskinesias for preladenant 10 mg - placebo."||
1687158|NCT01155466|3103246|Superiority or Other||Odds Ratio (OR)|0.994||||0.983|2-Sided|95.0|0.597|1.657|||Mixed Models Analysis|Odds ratio was calculated for all randomized and treated participants with at least 1 post treatment value.|"Confidence intervals and P-values were based on a generalized linear mixed model with baseline average off time as a covariate and treatment-by-time interaction as fixed effect and participant as random effect."||
1687159|NCT01155466|3103247|Superiority or Other||Risk Difference (RD)|0.3||||0.3941|2-Sided|95.0|-0.43|1.08|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 10 mg - placebo||
1687160|NCT01155466|3103247|Superiority or Other||Risk Difference (RD)|0.4||||0.3439|2-Sided|95.0|-0.4|1.14|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 5 mg - placebo||
1687161|NCT01155466|3103247|Superiority or Other||Risk Difference (RD)|0.1||||0.7044|2-Sided|95.0|-0.61|0.9|||Constrained longitudinal data analysis||The estimated parameter is the difference in the change from baseline in mean ESS score for preladenant 2 mg - placebo||
1687162|NCT01155466|3103248|Superiority or Other||Risk Difference (RD)|-2.6||||0.948|2-Sided|95.0|-6.8|0.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 10 mg - placebo||
1687163|NCT01155466|3103248|Superiority or Other||Risk Difference (RD)|-0.6||||0.625|2-Sided|95.0|-5.1|3.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 5 mg - placebo||
1687164|NCT01155466|3103248|Superiority or Other||Risk Difference (RD)|-0.6||||0.629|2-Sided|95.0|-5.1|3.7|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with suicidality for preladenant 2 mg - placebo||
1687165|NCT01155466|3103251|Superiority or Other||Risk Difference (RD)|1.4||||0.295|2-Sided|95.0|-3.9|6.9|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure >=105 mm Hg for preladenant 10 mg - placebo||
1687166|NCT01155466|3103251|Superiority or Other||Risk Difference (RD)|-1.9||||0.815|2-Sided|95.0|-6.8|2.6|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure >=105 mm Hg for preladenant 5 mg - placebo||
1687167|NCT01155466|3103251|Superiority or Other||Risk Difference (RD)|-2.6||||0.899|2-Sided|95.0|-7.3|1.6|||Miettinen & Nurminen||The estimated parameter is the difference in the percentage of participants with diastolic blood pressure >=105 mm Hg for preladenant 2 mg - placebo||
1687168|NCT01155466|3103253|Superiority or Other||Mean Difference (Final Values)|0.0||||0.87|2-Sided|95.0|-0.62|0.53|||Mixed Models Analysis||"The estimated parameter is the difference in the estimated mean change from baseline in mean off time for preladenant 10 mg - placebo."||
1687169|NCT01155323|3103260|Non-Inferiority or Equivalence|Margin = +/- 0.50|Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.01|0.06|||||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A from limbal hyperemia.|
1687170|NCT01155323|3103261|Non-Inferiority or Equivalence|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.15|0.29|||||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for quality perceptions.|
1687171|NCT01155323|3103262|Non-Inferiority or Equivalence|Margin = +/-0.50|Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.01|||2-Sided|95.0|-0.03|0.01|||||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A for corneal staining.|
1687172|NCT01155323|3103263|Non-Inferiority or Equivalence|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.22|0.22|||||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for lens handling.|
1687173|NCT01155323|3103264|Non-Inferiority or Equivalence|Non-inferiority margin = -0.50|Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.19|0.25|||||The mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for vision.|
1687174|NCT01155323|3103265|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.21|0.23|||||Mean difference is calculated as etafilcon A minus omafilcon A.|The alternative hypothesis was that etafilcon A would be superior to omafilcon A for comfort.|
1687175|NCT01155284|3103266|Superiority or Other|||||||0.869|||||||ANCOVA||||
1687176|NCT01155284|3103267|Superiority or Other|||||||0.81||||||The p value between treatment groups of C-peptide log (AUC+1) with covariate analysis adjusted for age, sex, baseline C-peptide concentration and duration of diabetes.|ANCOVA||||
1687177|NCT01155219|3103268|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1687178|NCT01155024|3103299|Non-Inferiority or Equivalence|10 participants required to detect one value change in rating for the SCS scale, with 80% power.|||||>|0.4||||||Two-Sided|t-test, 2 sided|||Alpha level of 0.05|
1687179|NCT01154985|3103303|Superiority or Other||Mean Difference (Final Values)|16.0|||||2-Sided|95.0|3.1|28.9||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.|
1687180|NCT01154985|3103303|Superiority or Other|||||||0.0153||||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.|
1687181|NCT01154985|3103303|Superiority or Other||Mean Difference (Final Values)|9.6|||||2-Sided|95.0|-3.8|23.0||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.|
1687182|NCT01154985|3103303|Superiority or Other|||||||0.1592||||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.|
1687183|NCT01154985|3103304|Superiority or Other||Mean Difference (Final Values)|22.0|||||2-Sided|95.0|9.6|34.4||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.|
1687184|NCT01154985|3103304|Superiority or Other|||||||0.0006||||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 2,700 mg/day EPA-E treatment group compared to placebo.|
1687185|NCT01154985|3103304|Superiority or Other||Mean Difference (Final Values)|16.2|||||2-Sided|95.0|3.4|29.1||||||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.|
1687186|NCT01154985|3103304|Superiority or Other|||||||0.0137||||||Two-sided p-values testing for significance was performed within treatment group change from baseline and comparisons between treatment groups. Multiple comparison techniques were not applied.|ANCOVA|||Least Squares (LS) mean, 95% CI and 2-sided p-value obtained from ANCOVA model with treatment group as a factor and baseline ALT as a covariate. 1,800 mg/day EPA-E treatment group compared to placebo.|
1687187|NCT01154985|3103305|Superiority or Other|||||||0.57|||||||Cochran-Armitage trend test|||Proportion of responders in the EPA-E 1800 mg and 2700 mg groups compared to the proportion of responders in the placebo group compared using the Cochran-Armitage trend test in the Efficacy Evaluable analysis set. P-value less than 5% 1-sided. A total sample size of 210 (70 per arm) was planned to give 80% power for detecting a positive dose-response slope among the 3 treatment arms at 12 months.|
1687188|NCT01154699|3103334|Superiority or Other|||||||0.76|||||||t-test, 2 sided||||
1687189|NCT01154699|3103335|Superiority or Other|||||||0.94|||||||t-test, 2 sided||||
1687190|NCT01154699|3103336|Superiority or Other|||||||0.61|||||||t-test, 2 sided||||
1687191|NCT01154699|3103337|Superiority or Other|||||||0.78|||||||t-test, 2 sided||||
1687192|NCT01154699|3103338|Superiority or Other|||||||0.2|||||||t-test, 2 sided|||Change in PC20 between the two arms|
1687193|NCT01154699|3103339|Superiority or Other|||||||0.8|||||||t-test, 2 sided|||The difference in the change in asthma control during the Usual care and the Bilevel PAP period were compared.|
1687194|NCT01154673|3103340|Superiority or Other||Mean Difference (Final Values)|0.2||||0.056|2-Sided|95.0|-0.006|0.4||"The estimated difference in mean change from baseline to 48 weeks was calculated as the log DNA copies/106 CD4+ T cells in Intensive HAART minus the log DNA copies/106 CD4+ T cells in Placebo Arm"|Regression, Linear||"The estimated difference in mean change from baseline to 48 weeks was calculated as the log DNA copies/106 CD4+ T cells in Intensive HAART minus the log DNA copies/106 CD4+ T cells in Placebo Arm"||
1687195|NCT01154296|3103358|Superiority or Other||Adjusted Risk Ratio (aRR)|1.14||||||95.0|0.89|1.46|||||||
1687196|NCT01154296|3103359|Superiority or Other||Incidence Rate Ratio (IRR)|0.97|||||2-Sided|95.0|0.9|1.05|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.|
1687197|NCT01154296|3103360|Superiority or Other||Incidence Rate Ratio (IRR)|0.88|||||2-Sided|95.0|0.82|0.94|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.|
1687212|NCT01154218|3103377|Superiority or Other||Ratio of Adjusted Means|106.97|||||2-Sided|90.0|96.55|118.51||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687454|NCT01152450|3103809|Superiority or Other||Mean Difference (Final Values)|0.065|Standard Error of the Mean|0.777||||95.0|-1.468|1.599|||||Tio R5 qd - Tio R2.5 bid||
1687198|NCT01154296|3103361|Superiority or Other||Incidence Rate Ratio (IRR)|0.98|||||2-Sided|95.0|0.86|1.13|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.|
1687199|NCT01154296|3103362|Superiority or Other||Incidence rate ratio (IRR)|0.99|||||2-Sided|95.0|0.9|1.09|||||In the statistical tests of all hypotheses and calculation of the presented IRR, we used multiple imputations of data sets with all 5012 cases. The adjusted IRRs reported are based on multiply imputed data. Counts are based on the observed data.|Analyses of sexual risk behaviors used zero-inflated negative binomial regressions (ZINB) including treatment group, baseline level of the risk behavior, site, and randomization stratum. (ZINB regression was used instead of ANCOVA because the outcome variable had an excessive number of zeroes and over dispersion.) Adjusted incidence rate ratios (IRR) from the models are presented.|
1687200|NCT01154296|3103363|Superiority or Other||adjusted risk ratio (aRR)|1.12|||||2-Sided|95.0|0.94|1.33||||||A total of 2039/2505 participants randomized to the counseling group and 2032/2507 to the information-only group had complete follow-up STI data. Cumulative STI incidence was 250/2039 (12.3%) in the counseling group and 226/2032 (11.1%) in the information-only group (aRR, 1.12; 95%CI, 0.94-1.33).|
1687201|NCT01154218|3103372|Superiority or Other||Ratio of Adjusted means|71.94|||||2-Sided|90.0|65.46|79.05||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687202|NCT01154218|3103372|Superiority or Other||Ratio of Adjusted means|108.87|||||2-Sided|90.0|98.98|119.75||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687203|NCT01154218|3103372|Superiority or Other||Ratio of Adjusted means|102.11|||||2-Sided|90.0|92.84|112.31||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687204|NCT01154218|3103373|Superiority or Other||Ratio of Adjusted means|76.59|||||2-Sided|90.0|69.23|84.74||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687205|NCT01154218|3103373|Superiority or Other||Ratio of Adjusted means|108.47|||||2-Sided|90.0|98.03|120.02||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687206|NCT01154218|3103373|Superiority or Other||Ratio of Adjusted means|100.08|||||2-Sided|90.0|90.46|110.73||||||Natural log transformed AUC (0-∞) of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687207|NCT01154218|3103374|Superiority or Other||Ratio of Adjusted means|74.87|||||2-Sided|90.0|67.55|82.98||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687208|NCT01154218|3103374|Superiority or Other||Ratio of Adjusted means|108.85|||||2-Sided|90.0|98.11|120.77||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687209|NCT01154218|3103374|Superiority or Other||Ratio of Adjusted means|100.03|||||2-Sided|90.0|90.16|110.97||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687210|NCT01154218|3103377|Superiority or Other||Ratio of Adjusted Means|86.22|||||2-Sided|90.0|77.89|95.43||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687211|NCT01154218|3103377|Superiority or Other||Ratio of Adjusted Means|111.32|||||2-Sided|90.0|100.47|123.33||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687455|NCT01152450|3103809|Superiority or Other||Mean Difference (Final Values)|0.389|Standard Error of the Mean|0.774||0.6159||95.0|-1.138|1.916|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687213|NCT01154218|3103380|Superiority or Other||Ratio of Adjusted means|85.52|||||2-Sided|90.0|78.45|93.22||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687214|NCT01154218|3103380|Superiority or Other||Ratio of Adjusted means|107.56|||||2-Sided|90.0|98.58|117.35||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687215|NCT01154218|3103380|Superiority or Other||Ratio of Adjusted means|99.6|||||2-Sided|90.0|91.3|108.66||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687216|NCT01154218|3103381|Superiority or Other||Ratio of Adjusted Means|85.76|||||2-Sided|90.0|78.88|93.25||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687217|NCT01154218|3103381|Superiority or Other||Ratio of Adjusted means|106.93|||||2-Sided|90.0|98.26|116.35||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687218|NCT01154218|3103381|Superiority or Other||Ratio of Adjusted Means|99.56|||||2-Sided|90.0|91.49|108.33||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687219|NCT01154166|3103398|Superiority or Other||Adjusted mean for treatment difference|-1.76|||<|0.001|2-Sided|95.0|-2.27|-1.26|||ANCOVA||The estimated value indicates the treatment difference for the adjusted mean for Ropinirole PR and placebo.||
1687220|NCT01154153|3103401|Superiority or Other|||||||0.3314||||||Based on the ordinal evaluation score and adjusted for the randomization strata.|Cochran-Mantel-Haenszel||||
1687221|NCT01154153|3103402|Superiority or Other|||||||0.1332||||||Based on the ordinal evaluation score and adjusted for the randomization strata.|Cochran-Mantel-Haenszel||||
1687222|NCT01154153|3103403|Superiority or Other||LS Mean Difference|-0.85|Standard Error of the Mean|0.24||0.0007|2-Sided|95.0|-1.34|-0.37|||ANCOVA|For ANCOVA, treatment arm, randomization strata were fixed effects and baseline value was a covariate.|||
1687223|NCT01154153|3103404|Superiority or Other||Treatment Ratio of Geometric mean|0.966|||||2-Sided|95.0|0.892|1.045|||||The treatment ratio was calculated as an exponential of the mean difference between treatments in log scale.|Missing cortisol values were imputed with multiple imputation. AUC(0-24 hr) was calculated for each imputation and analyzed with log-transformation using an ANCOVA model and analyzed with treatment, sex, and age group as fixed effects, and log-transformed baseline value as a covariate. The mean difference in log scale between treatments and its standard error were calculated by Least Squares mean. Results from multiply imputed data were combined using SAS procedure MIANALYZE.|
1687224|NCT01154140|3103408|Superiority or Other||Mean Difference (Net)|3.9908||||0.0139|2-Sided|95.0|0.81|7.17|||Mixed Models Analysis|||Analysis was based on a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EQ-5D VAS subscale baseline score (intercept and time from first dose were included as random effects).|
1687225|NCT01154140|3103409|Superiority or Other||Mean Difference (Net)|-2.1521||||0.1382|2-Sided|95.0|-5.0|0.69|||Mixed Models Analysis|||QLQ-LC13 sore mouth: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).|
1687226|NCT01154140|3103409|Superiority or Other||Mean Difference (Net)|3.3521||||0.0427|2-Sided|95.0|0.11|6.59|||Mixed Models Analysis|||QLQ-LC13 peripheral neuropathy: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).|
1687227|NCT01154140|3103409|Superiority or Other||Mean Difference (Net)|-6.7717||||0.0001|2-Sided|95.0|-10.24|-3.31|||Mixed Models Analysis|||QLQ-LC13 pain in other parts: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).|
1687228|NCT01154140|3103409|Superiority or Other||Mean Difference (Net)|-8.0959|||<|0.0001|2-Sided|95.0|-11.35|-4.84|||Mixed Models Analysis|||QLQ-LC13 pain in chest: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).|
1687229|NCT01154140|3103409|Superiority or Other||Mean Difference (Net)|-6.0475|||<|0.0002|2-Sided|95.0|-9.22|-2.88|||Mixed Models Analysis|||QLQ-LC13 pain in arm or shoulder: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).|
1687230|NCT01154140|3103409|Superiority or Other||Mean Difference (Net)|-0.8828|||<|0.0656|2-Sided|95.0|-1.82|0.06|||Mixed Models Analysis|||QLQ-LC13 haemoptysis: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).|
1687231|NCT01154140|3103409|Superiority or Other||Mean Difference (Net)|-9.008|||<|0.0001|2-Sided|95.0|-11.96|-6.06|||Mixed Models Analysis|||QLQ-LC13 dyspnoea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).|
1687232|NCT01154140|3103409|Superiority or Other||Mean Difference (Net)|0.6651|||<|0.5938|2-Sided|95.0|-1.78|3.11|||Mixed Models Analysis|||QLQ-LC13 dysphagia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).|
1687233|NCT01154140|3103409|Superiority or Other||Mean Difference (Net)|-8.3926|||<|0.0001|2-Sided|95.0|-12.06|-4.72|||Mixed Models Analysis|||QLQ-LC13 coughing: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).|
1687234|NCT01154140|3103409|Superiority or Other||Mean Difference (Net)|-4.8149|||<|0.0108|2-Sided|95.0|-8.52|-1.11|||Mixed Models Analysis|||QLQ-LC13 alopecia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-LC13 subscale baseline score (intercept and time from first dose are included as random effects).|
1687235|NCT01154140|3103410|Superiority or Other||Mean Difference (Net)|-9.9277|||<|0.0001|2-Sided|95.0|-13.23|-6.62|||Mixed Models Analysis|||QLQ-C30 pain: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687236|NCT01154140|3103410|Superiority or Other||Mean Difference (Net)|-3.4446|||<|0.0468|2-Sided|95.0|-6.84|-0.05|||Mixed Models Analysis|||QLQ-C30 nausea and vomiting: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687237|NCT01154140|3103410|Superiority or Other||Mean Difference (Net)|-10.043|||<|0.0001|2-Sided|95.0|-14.22|-5.87|||Mixed Models Analysis|||QLQ-C30 insomnia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687238|NCT01154140|3103410|Superiority or Other||Mean Difference (Net)|-0.8186|||<|0.6681|2-Sided|95.0|-4.56|2.92|||Mixed Models Analysis|||QLQ-C30 financial difficulties: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687239|NCT01154140|3103410|Superiority or Other||Mean Difference (Net)|-14.9987|||<|0.0001|2-Sided|95.0|-18.52|-11.48|||Mixed Models Analysis|||QLQ-C30 fatigue: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687240|NCT01154140|3103410|Superiority or Other||Median Difference (Net)|-13.4622|||<|0.0001|2-Sided|95.0|-17.2|-9.73|||Mixed Models Analysis|||QLQ-C30 dysponea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687241|NCT01154140|3103410|Superiority or Other||Mean Difference (Net)|12.4906|||<|0.0001|2-Sided|95.0|8.98|16.0|||Mixed Models Analysis|||QLQ-C30 diarrhea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687242|NCT01154140|3103410|Superiority or Other||Mean Difference (Net)|-4.4336|||<|0.057|2-Sided|95.0|-9.0|0.13|||Mixed Models Analysis|||QLQ-C30 constipation: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687243|NCT01154140|3103410|Superiority or Other||Mean Difference (Net)|-13.4976|||<|0.0001|2-Sided|95.0|-18.03|-8.97|||Mixed Models Analysis|||QLQ-C30 appetite loss: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687244|NCT01154140|3103411|Superiority or Other||Mean Difference (Net)|8.7641|||<|0.0001|2-Sided|95.0|4.69|12.84|||Mixed Models Analysis|||QLQ-C30 social functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687245|NCT01154140|3103411|Superiority or Other||Mean Difference (Net)|15.5513|||<|0.0001|2-Sided|95.0|11.29|19.81|||Mixed Models Analysis|||QLQ-C30 role functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687246|NCT01154140|3103411|Superiority or Other||Mean Difference (Net)|10.4035|||<|0.0001|2-Sided|95.0|7.48|13.32|||Mixed Models Analysis|||QLQ-C30 physical functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687247|NCT01154140|3103411|Superiority or Other||Mean Difference (Net)|7.5165|||<|0.0001|2-Sided|95.0|4.57|10.46|||Mixed Models Analysis|||QLQ-C30 emotional functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687248|NCT01154140|3103411|Superiority or Other||Mean Difference (Net)|3.3532|||<|0.017|2-Sided|95.0|0.6|6.11|||Mixed Models Analysis|||QLQ-C30 cognitive functioning: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687249|NCT01154140|3103411|Superiority or Other||Mean Difference (Net)|13.8303|||<|0.0001|2-Sided|95.0|10.74|16.92|||Mixed Models Analysis|||QLQ-C30 Global QoL: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).|
1687250|NCT01154140|3103412|Superiority or Other||Hazard Ratio (HR)|0.591||||0.0002|2-Sided|95.0|0.452|0.773||Two-sided p-value from the unstratified log rank test was used.|Log Rank|||HR was calculated based on the Cox Proportional hazards model. Assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of crizotinib.|
1687251|NCT01154140|3103419|Superiority or Other||Hazard Ratio (HR)|0.387|||<|0.0001|2-Sided|95.0|0.286|0.524||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.|
1687252|NCT01154140|3103420|Superiority or Other||Hazard Ratio (HR)|0.595||||0.0347|2-Sided|95.0|0.338|1.048||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR less than 1 indicated a reduction in hazard rate in favor of Crizotinib.|
1687253|NCT01154140|3103421|Superiority or Other||Hazard Ratio (HR)|0.441|||<|0.0001|2-Sided|95.0|0.335|0.582||P-value was obtained from 1-sided unstratified log-rank test.|Log Rank|||Analysis was based on the Cox Proportional hazards model assuming proportional hazards, a HR <1 indicated a reduction in hazard rate in favor of Crizotinib.|
1687254|NCT01154140|3103422|Superiority or Other||Difference in Percentage|10.067||||0.0381|2-Sided|95.0|0.8|19.4|||Pearson chi-square test|||The confidence interval for the difference in percentage was based on normal distribution.|
1687255|NCT01154140|3103425|Superiority or Other||Difference in Percentage|29.4|||<|0.0001|2-Sided|95.0|19.5|39.3||P-value was obtained from a Pearson chi-square test.|Pearson chi-square test||95% CI was calculated based on normal distribution.|If the PFS endpoint was significant, ORR was to be considered significant if the 2-sided p-value from Pearson chi-square test was (less than or equal to)<= 0.0494.|
1687256|NCT01154140|3103427|Superiority or Other||Hazard Ratio (HR)|0.76||||0.0489|2-Sided|95.0|0.548|1.053||P-value was obtained from 1-sided log rank test, stratified by ECOG PS, race group and brain metastases.|Log Rank||HR was calculated based on the Cox Proportional hazards model stratified by ECOG PS, race group, and brain metastases. Assuming proportional hazards, a hazard ratio (less than)<1 indicates a reduction in hazard rate in favor of crizotinib.||
1687257|NCT01154140|3103428|Superiority or Other||Hazard Ratio (HR)|0.454|||<|0.0001|2-Sided|95.0|0.346|0.596||P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group performance status (ECOG PS),race,brain metastases. 1-sided log-rank test at 0.0247 level of significance was used to compare PFS between the 2 arms.|Log Rank||||
1687258|NCT01154088|3103460|Non-Inferiority|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|0.88|||||2-Sided|95.0|0.78|0.99||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups Y, 1 month after vaccination as measured at GSK.|
1687259|NCT01154088|3103460|Non-Inferiority|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|0.91|||||2-Sided|95.0|0.8|1.04||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups W-135, 1 month after vaccination as measured at GSK.|
1687260|NCT01154088|3103460|Non-Inferiority|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|1.15|||||2-Sided|95.0|0.96|1.37||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups C, 1 month after vaccination as measured at GSK.|
1687261|NCT01154088|3103460|Non-Inferiority|Criterion for non-inferiority: Non-inferiority of Nimenrix Lot B vs. Nimenrix Lot A in terms of non-inferiority would be demonstrated if the upper limit (UL) of the 2-sided 95% CIs on the rSBA GMT ratios (GMTs of Nimenrix Lot B over the GMTs of the Nimenrix Lot A) would be below (<) a limit of 2-fold for antibodies against all meningococcal serogroups.|Adjusted GMT ratio|1.04|||||2-Sided|95.0|0.92|1.17||||||Demonstration of the comparability of the immunogenicity of Lot A to Lot B of Nimenrix conjugate vaccine with respect to rSBA geometric mean titres (GMTs) for N. meningitidis serogroups A, 1 month after vaccination as measured at GSK.|
1687262|NCT01154088|3103461|Non-Inferiority|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|7.02|||||2-Sided|95.0|2.63|11.58||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups Y as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.|
1687282|NCT01154036|3103470|Superiority or Other||Difference in M-estimates|-6.4|||<|0.001|2-Sided|95.0|-9.4|-3.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687283|NCT01154036|3103470|Superiority or Other||Difference in M-estimates|-6.9|||<|0.001|2-Sided|95.0|-11.0|-2.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687263|NCT01154088|3103461|Non-Inferiority|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|6.83|||||2-Sided|95.0|3.28|10.78||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups W-135 as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.|
1687264|NCT01154088|3103461|Non-Inferiority|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|-0.41|||||2-Sided|95.0|-4.11|3.25||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups C as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.|
1687265|NCT01154088|3103461|Non-Inferiority|Criterion for non-inferiority: For each serogroup separately, the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) for the group difference (Nimenrix-A Group minus Mencevax Group) in the percentage of subjects with bactericidal vaccine response would be greater than or equal to (≥) the pre-defined clinical limit of -10%.|Difference in vaccine response rate|5.42|||||2-Sided|95.0|-1.41|12.25||||||Demonstration of the non-inferiority of the vaccine response induced by Nimenrix conjugate vaccine (Nimenrix Lot A) when compared to the licensed Mencevax for Neisseria meningitidis (N. meningitidis) serogroups A as measured by serum bactericidal antibodies using baby rabbit complement (rSBA) at GSK.|
1687266|NCT01154036|3103462|Superiority or Other||Difference in Least-squares Means|-11.6||||0.153|2-Sided|95.0|-27.7|4.4|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means|||
1687267|NCT01154036|3103462|Superiority or Other||Difference in Least-squares Means|-13.1||||0.187|2-Sided|95.0|-32.6|6.4|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means|||
1687268|NCT01154036|3103463|Superiority or Other||Difference in Least-squares Means|-1.5||||0.831|2-Sided|95.0|-15.7|12.6|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means|||
1687269|NCT01154036|3103463|Superiority or Other||Difference in Least-squares Means|-3.9||||0.613|2-Sided|95.0|-18.9|11.1|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means|||
1687270|NCT01154036|3103464|Superiority or Other||Difference in M-estimates|-8.4|||<|0.001|2-Sided|95.0|-12.6|-4.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687271|NCT01154036|3103464|Superiority or Other||Difference in M-estimates|-9.3|||<|0.001|2-Sided|95.0|-14.8|-3.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687272|NCT01154036|3103465|Superiority or Other||Difference in M-estimates|-6.2||||0.002|2-Sided|95.0|-10.2|-2.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687273|NCT01154036|3103465|Superiority or Other||Difference in M-estimates|-10.6|||<|0.001|2-Sided|95.0|-14.9|-6.4|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687274|NCT01154036|3103466|Superiority or Other||Difference in M-estimates|-6.1||||0.002|2-Sided|95.0|-9.9|-2.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687275|NCT01154036|3103466|Superiority or Other||Difference in M-estimates|-5.8||||0.024|2-Sided|95.0|-10.8|-0.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687276|NCT01154036|3103467|Superiority or Other||Difference in M-estimates|-3.5||||0.052|2-Sided|95.0|-7.1|0.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687277|NCT01154036|3103467|Superiority or Other||Difference in M-estimates|-6.3|||<|0.001|2-Sided|95.0|-10.0|-2.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687278|NCT01154036|3103468|Superiority or Other||Difference in M-estimates|-8.3|||<|0.001|2-Sided|95.0|-12.5|-4.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687279|NCT01154036|3103468|Superiority or Other||Difference in M-estimates|-10.4|||<|0.001|2-Sided|95.0|-15.8|-4.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687280|NCT01154036|3103469|Superiority or Other||Difference in M-estimates|-7.8|||<|0.001|2-Sided|95.0|-11.9|-3.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687281|NCT01154036|3103469|Superiority or Other||Difference in M-estimates|-13.7|||<|0.001|2-Sided|95.0|-18.1|-9.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687284|NCT01154036|3103471|Superiority or Other||Difference in M-estimates|-4.8||||0.001|2-Sided|95.0|-7.8|-1.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687285|NCT01154036|3103471|Superiority or Other||Difference in M-estimates|-8.1|||<|0.001|2-Sided|95.0|-11.2|-4.9|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687286|NCT01154036|3103472|Superiority or Other||Difference in M-estimates|-9.8||||0.001|2-Sided|95.0|-13.5|-6.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687287|NCT01154036|3103472|Superiority or Other||Difference in M-estimates|-9.3|||<|0.001|2-Sided|95.0|-14.0|-4.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687288|NCT01154036|3103473|Superiority or Other||Difference in M-estimates|-7.6|||<|0.001|2-Sided|95.0|-10.9|-4.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687289|NCT01154036|3103473|Superiority or Other||Difference in M-estimates|-10.1|||<|0.001|2-Sided|95.0|-13.6|-6.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687290|NCT01154036|3103474|Superiority or Other||Difference in M-estimates|-1.0||||0.41|2-Sided|95.0|-3.3|1.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687291|NCT01154036|3103474|Superiority or Other||Difference in M-estimates|0.5||||0.739|2-Sided|95.0|-2.5|3.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687292|NCT01154036|3103475|Superiority or Other||Difference in M-estimates|-0.9||||0.425|2-Sided|95.0|-2.9|1.2|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687293|NCT01154036|3103475|Superiority or Other||Difference in M-estimates|1.6||||0.156|2-Sided|95.0|-0.6|3.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687294|NCT01154036|3103476|Superiority or Other||Difference in M-estimates|-7.7|||<|0.001|2-Sided|95.0|-11.4|-4.1|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687295|NCT01154036|3103476|Superiority or Other||Difference in M-estimates|-4.3|||<|0.079|2-Sided|95.0|-9.2|0.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687296|NCT01154036|3103477|Superiority or Other||Difference in M-estimates|-4.3||||0.011|2-Sided|95.0|-7.7|-1.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687297|NCT01154036|3103477|Superiority or Other||Difference in M-estimates|-5.3||||0.003|2-Sided|95.0|-8.8|-1.8|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687298|NCT01154036|3103478|Superiority or Other||Difference in M-estimates|-0.7||||0.567|2-Sided|95.0|-3.1|1.7|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687299|NCT01154036|3103478|Superiority or Other||Difference in M-estimates|-1.0||||0.52|2-Sided|95.0|-4.2|2.1|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687300|NCT01154036|3103479|Superiority or Other||Difference in M-estimates|-0.6||||0.61|2-Sided|95.0|-2.7|1.6|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687301|NCT01154036|3103479|Superiority or Other||Difference in M--estimates|1.7||||0.133|2-Sided|95.0|-0.5|4.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687302|NCT01154036|3103480|Superiority or Other||Difference in Least-squarres Means|-7.1||||0.011|2-Sided|95.0|-12.6|-1.6|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means|||
1687303|NCT01154036|3103480|Superiority or Other||Difference in Least-squares Means|-2.8||||0.466|2-Sided|95.0|-10.2|4.7|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means|||
1687304|NCT01154036|3103481|Superiority or Other||Difference in Least-squares means|-4.9||||0.081|2-Sided|95.0|-10.3|0.5|||Constrained Longitudinal Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means|||
1687305|NCT01154036|3103481|Superiority or Other||Difference in least-squares means|-2.1||||0.466|2-Sided|95.0|-7.8|3.5|||Constrained Longitudinal Data Analysis|Geometric mean percent changes from baseline were calculated based on back-transformation via exponentiation of the model-based least square means|||
1687306|NCT01154036|3103482|Superiority or Other||Difference in M-estimates|-7.4|||<|0.001|2-Sided|95.0|-10.2|-4.5|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1690622|NCT01118455|3108498|Superiority or Other|||||||0.025|||||||t-test, 2 sided||||
1687307|NCT01154036|3103482|Superiority or Other||Difference in M-estimates|-6.8|||<|0.001|2-Sided|95.0|-10.7|-3.0|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687308|NCT01154036|3103483|Superiority or Other||Difference in M-estimates|-5.8|||<|0.001|2-Sided|95.0|-8.3|-3.3|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687309|NCT01154036|3103483|Superiority or Other||Difference in M-estimates|-7.1|||<|0.001|2-Sided|95.0|-9.7|-4.4|||Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687310|NCT01154036|3103484|Superiority or Other||Odds Ratio (OR)|7.08|||<|0.001|2-Sided|95.0|2.85|17.56|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)|||
1687311|NCT01154036|3103484|Superiority or Other||Odds Ratio (OR)|27.77|||<|0.001|2-Sided|95.0|3.64|211.83|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)|||
1687312|NCT01154036|3103485|Superiority or Other||Odds Ratio (OR)|3.9|||<|0.001|2-Sided|95.0|2.23|6.82|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)|||
1687313|NCT01154036|3103485|Superiority or Other||Odds Ratio (OR)|9.46|||<|0.001|2-Sided|95.0|4.56|19.62|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)|||
1687314|NCT01154036|3103486|Superiority or Other||Odds Ratio (OR)|2.38|||<|0.001|2-Sided|95.0|1.56|3.63|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)|||
1687315|NCT01154036|3103486|Superiority or Other||Odds Ratio (OR)|2.71|||<|0.001|2-Sided|95.0|1.55|4.73|||Logistic regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)|||
1687316|NCT01154036|3103487|Superiority or Other||Odds Ratio (OR)|1.77||||0.007|2-Sided|95.0|1.17|2.67|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)|||
1687317|NCT01154036|3103487|Superiority or Other||Odds Ratio (OR)|2.51|||<|0.001|2-Sided|95.0|1.62|3.89|||Logistic Regression Model|Logistic regression model included terms for treatment and baseline LDL-C (where baseline LDL-C was fitted as 3 categories based on tertiles)|||
1687318|NCT01154036|3103488|Superiority or Other||Difference in M-estimates|-9.5|||<|0.001|2-Sided|95.0|-13.6|-5.5||The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687319|NCT01154036|3103488|Superiority or Other||Difference in M-estimates|-10.5|||<|0.001|2-Sided|95.0|-15.9|-5.1||The secondary hypotheses were tested at an adaptive alpha level depending on the hypotheses testing result of the primary hypotheses.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687320|NCT01154036|3103489|Superiority or Other||Difference in M-estimate|-9.1|||<|0.001|2-Sided|95.0|-12.9|-5.4||The primary hypotheses were tested at 0.045, applying Hochberg’s procedure.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687321|NCT01154036|3103489|Superiority or Other||Difference in M-estimates|-12.7|||<|0.001|2-Sided|95.0|-16.6|-8.7||The primary hypotheses were tested at 0.045, applying Hochberg’s procedure.|Multiple Imputation Robust Regression|M-Estimates, 95% CI, and p-value obtained from a robust regression model with terms for treatment and baseline values, after imputing missing values|||
1687322|NCT01153971|3103516|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1687323|NCT01153815|3103546|Superiority or Other||||||<|0.001|||||||Exact Smirnov test||||
1687324|NCT01153763|3103552|Other||percentage of participants|13.0|||||2-Sided|95.0|2.2|34.6|||||The estimated value represents the percentage of participants with overall survival.||
1687325|NCT01153763|3103553|Other||percentage of participants|20.0|||||2-Sided|95.0|11.6|29.8|||||The estimated value represents the percentage of participants with overall survival.||
1687326|NCT01153763|3103558|Other||percentage of participants|13.0|||||2-Sided|95.0|0.0|28.7|||||The estimated value represents the percentage of participants with a investigator assessed CR or PR.||
1687327|NCT01153763|3103559|Other||percentage of participants|59.0|||||2-Sided|95.0|48.2|70.3|||||The estimated value represents the percentage of participants with a confirmed CR or a confirmed PR.||
1687328|NCT01153724|3103562|Non-Inferiority or Equivalence|Relative bioavailability|Adjusted geometric mean ratio|74.08|Standard Deviation|14.6||0.9646|2-Sided|90.0|69.105|79.418||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol|
1687329|NCT01153724|3103563|Non-Inferiority or Equivalence|Relative bioavailability|Adjusted geometric mean ratio|74.48|Standard Deviation|1.068||0.8574|2-Sided|90.0|66.619|83.266||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide|
1687330|NCT01153724|3103563|Non-Inferiority or Equivalence|Relative bioavailability|Adjusted geometric mean ratio|114.83|Standard Deviation|33.5||0.1539|2-Sided|90.0|99.94|131.932||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol|
1688107|NCT01143324|3105102|Superiority or Other||Difference from pre-op mean|0.35|||<|0.0001|2-Sided|95.0|0.3|0.41|||t-test, 2 sided||||
1687331|NCT01153724|3103566|Non-Inferiority or Equivalence|Relative bioavailability|Adjusted geometric mean|85.98|Standard Deviation|19.4||0.0711|2-Sided|90.0|79.277|93.253||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol glucuronide|
1687332|NCT01153724|3103566|Non-Inferiority or Equivalence|Relative bioavailability|Adjusted geometric mean ratio|108.78|Standard Deviation|15.5||0.0009|2-Sided|90.0|101.59|116.487||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol for the category Olodaterol|
1687333|NCT01153724|3103567|Non-Inferiority or Equivalence|Relative bioavailability|Adjusted geometric mean ratio|113.29|Standard Deviation|13.6||0.0101|2-Sided|90.0|105.893|121.197||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Fluconazole and Olodaterol|
1687334|NCT01153711|3103570|Non-Inferiority or Equivalence|Relative bioavailability|Adjusted geometric mean ratio|100.75|Standard Deviation|17.9||0.0001|2-Sided|90.0|92.534|109.692||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol|
1687335|NCT01153711|3103571|Non-Inferiority or Equivalence|Relative bioavailability|Adjusted geometric mean ratio|132.87|Standard Deviation|18.9||0.8991|2-Sided|90.0|122.732|143.843||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide|
1687336|NCT01153711|3103571|Non-Inferiority or Equivalence|Relative bioavailability|Adjusted geometric mean ratio|144.23|Standard Deviation|17.8||0.9986|2-Sided|90.0|133.853|155.417||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol|
1687337|NCT01153711|3103574|Non-Inferiority or Equivalence|Relative bioavailability|Adjusted geometric mean ratio|106.63|Standard Deviation|14.7||0.0001|2-Sided|90.0|100.211|113.463||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol glucuronide|
1687338|NCT01153711|3103574|Non-Inferiority or Equivalence|Relative bioavailability|Adjusted geometric mean ratio|166.1|Standard Deviation|16.8||1|2-Sided|90.0|153.6|179.6||P-value for ratio outside 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol for the category Olodaterol|
1687339|NCT01153711|3103575|Non-Inferiority or Equivalence|Relative bioavailability|Adjusted geometric mean ratio|168.4|Standard Deviation|16.4||1|2-Sided|90.0|155.5|182.4||P-value for ratio outside interval 0.8-1.25|ANOVA|Adjusted geometric mean ratio|The standard deviation is actually the geometric coefficient of variation|Ratio Olodaterol plus Ketoconazole and Olodaterol|
1687340|NCT01153633|3103601|Superiority or Other|||||||0.9945||||||F-test (2-sided), ANCOVA with baseline target ulcer size as covariate|F-test||||
1687341|NCT01153633|3103602|Superiority or Other|||||||0.4905|||||||Fisher Exact||||
1687342|NCT01153633|3103606|Superiority or Other|||||||0.2317||||||F-test (2-sided), ANCOVA with baseline target ulcer size as covariate|F-test||||
1687343|NCT01153620|3103610|Superiority or Other||||||=|0|||||||Wilcoxon (Mann-Whitney)||||
1687344|NCT01153581|3103611|Superiority or Other||Mean Difference (Final Values)|-1.16|||<|0.05|2-Sided||||||ANOVA||||
1687345|NCT01153425|3103618|Other|unpaired t-test for the difference of the means between the two arms|||||>|0.05|||||||t-test, 2 sided|||paired t-test for change from baseline to 24 months|
1687346|NCT01153347|3103620|Superiority or Other||LS mean|0.5|Standard Error of the Mean|1.58||0.745|2-Sided|95.0|-2.59|3.62|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687347|NCT01153347|3103620|Superiority or Other||LS mean|-1.3|Standard Error of the Mean|1.56||0.393|2-Sided|95.0|-4.41|1.73|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687348|NCT01153347|3103620|Superiority or Other||LS mean|-1.4|Standard Error of the Mean|1.55||0.35|2-Sided|95.0|-4.48|1.59|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SIS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687349|NCT01153347|3103621|Superiority or Other||LS mean|-1.2|Standard Error of the Mean|2.12||0.564|2-Sided|95.0|-5.39|2.94||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687350|NCT01153347|3103621|Superiority or Other||LS mean|1.5|Standard Error of the Mean|2.09||0.486|2-Sided|95.0|-2.65|5.56||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687351|NCT01153347|3103621|Superiority or Other||LS mean|1.9|Standard Error of the Mean|2.06||0.345|2-Sided|95.0|-2.1|6.0||Analysis of change in EQ-5D VAS score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D VAS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687352|NCT01153347|3103621|Superiority or Other||LS mean|-0.014|Standard Error of the Mean|0.0206||0.502|2-Sided|95.0|-0.0543|0.0267||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687353|NCT01153347|3103621|Superiority or Other||LS mean|-0.013|Standard Error of the Mean|0.0203||0.524|2-Sided|95.0|-0.0529|0.027||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687354|NCT01153347|3103621|Superiority or Other||LS mean|-0.006|Standard Error of the Mean|0.0201||0.747|2-Sided|95.0|-0.0459|0.0329||Analysis for change in EQ-5D index score from randomization (Week 8) to end of treatment (Week 16)|MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization EQ-5D total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687355|NCT01153347|3103622|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.1||0.666|2-Sided|95.0|-0.24|0.15|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.|
1687356|NCT01153347|3103622|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.1||0.721|2-Sided|95.0|-0.16|0.23|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.|
1687357|NCT01153347|3103622|Superiority or Other||LS mean|0.1|Standard Error of the Mean|0.1||0.353|2-Sided|95.0|-0.1|0.28|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 16 as a fixed effect and pooled center as a random effect.|
1687358|NCT01153347|3103623|Superiority or Other||LS mean|-0.2|Standard Error of the Mean|0.1||0.033|2-Sided|95.0|-0.42|-0.02|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1687359|NCT01153347|3103623|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.1||0.928|2-Sided|95.0|-0.19|0.21|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1687360|NCT01153347|3103623|Superiority or Other||LS mean|-0.1|Standard Error of the Mean|0.1||0.412|2-Sided|95.0|-0.28|0.11|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization Q-LES-Q-SF item 15 score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1687361|NCT01153347|3103624|Superiority or Other||LS mean|-1.88|Standard Error of the Mean|1.716||0.275|2-Sided|95.0|-5.248|1.494|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1687362|NCT01153347|3103624|Superiority or Other||LS mean|0.72|Standard Error of the Mean|1.702||0.673|2-Sided|95.0|-2.624|4.062|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1687363|NCT01153347|3103624|Superiority or Other||LS mean|2.1|Standard Error of the Mean|1.694||0.215|2-Sided|95.0|-1.224|5.431|||ANCOVA|||ANCOVA with randomization Q-LES-Q-SF % maximum total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1687364|NCT01153347|3103625|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.28||0.971|2-Sided|95.0|-0.55|0.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.|
1687365|NCT01153347|3103625|Superiority or Other||LS mean|-0.3|Standard Error of the Mean|0.27||0.343|2-Sided|95.0|-0.8|0.28|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.|
1687366|NCT01153347|3103625|Superiority or Other||LS mean|-0.3|Standard Error of the Mean|0.27||0.213|2-Sided|95.0|-0.87|0.19|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS family life/home responsibilities domain score. Treatment, visit and treatment by visit interaction are effects in the model; pooled center is a random effect.|
1687367|NCT01153347|3103626|Superiority or Other||LS mean|0.3|Standard Error of the Mean|0.27||0.237|2-Sided|95.0|-0.21|0.84|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687368|NCT01153347|3103626|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.26||0.972|2-Sided|95.0|-0.51|0.53|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687369|NCT01153347|3103626|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.26||0.915|2-Sided|95.0|-0.54|0.48|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS social life domain score. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687370|NCT01153347|3103627|Superiority or Other||LS mean|0.1|Standard Error of the Mean|0.3||0.792|2-Sided|95.0|-0.5|0.66|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687427|NCT01153009|3103742|Superiority or Other||LS Mean Difference|-0.34|Standard Error of the Mean|0.139||0.014|2-Sided|95.0|-0.61|-0.07|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.|||
1687371|NCT01153347|3103627|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.3||0.868|2-Sided|95.0|-0.64|0.54|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687372|NCT01153347|3103627|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.29||0.953|2-Sided|95.0|-0.56|0.59|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization SDS work/school domain score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687373|NCT01153347|3103628|Superiority or Other||LS mean|0.4|Standard Error of the Mean|0.761||1|2-Sided|95.0|-1.095|1.896||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687374|NCT01153347|3103628|Superiority or Other||LS mean|-0.52|Standard Error of the Mean|0.755||1|2-Sided|95.0|-2.004|0.96||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687375|NCT01153347|3103628|Superiority or Other||LS mean|-0.6|Standard Error of the Mean|0.746||1|2-Sided|95.0|-2.069|0.864||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization SDS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687376|NCT01153347|3103629|Superiority or Other||LS mean|0.1|Standard Error of the Mean|0.99||0.953|2-Sided|95.0|-1.89|2.01|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687377|NCT01153347|3103629|Superiority or Other||LS mean|-0.6|Standard Error of the Mean|0.98||0.547|2-Sided|95.0|-2.52|1.33|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687378|NCT01153347|3103629|Superiority or Other||LS mean|-0.3|Standard Error of the Mean|0.97||0.737|2-Sided|95.0|-2.23|1.58|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects the model; pooled center is a random effect.|
1687379|NCT01153347|3103630|Superiority or Other||LS mean|-0.4|Standard Error of the Mean|0.92||0.68|2-Sided|95.0|-2.2|1.43|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687380|NCT01153347|3103630|Superiority or Other||LS mean|-0.9|Standard Error of the Mean|0.91||0.321|2-Sided|95.0|-2.7|0.89|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687381|NCT01153347|3103630|Superiority or Other||LS mean|-0.9|Standard Error of the Mean|0.91||0.339|2-Sided|95.0|-2.65|0.92|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687382|NCT01153347|3103631|Superiority or Other||LS mean|-0.2|Standard Error of the Mean|0.75||0.762|2-Sided|95.0|-1.7|1.25|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687383|NCT01153347|3103631|Superiority or Other||LS mean|0.2|Standard Error of the Mean|0.74||0.793|2-Sided|95.0|-1.26|1.65|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687384|NCT01153347|3103631|Superiority or Other||LS mean|0.8|Standard Error of the Mean|0.74||0.303|2-Sided|95.0|-0.69|2.22|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687385|NCT01153347|3103632|Superiority or Other||LS mean|1.0|Standard Error of the Mean|0.62||0.1|2-Sided|95.0|-0.19|2.23|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687386|NCT01153347|3103632|Superiority or Other||LS mean|-0.1|Standard Error of the Mean|0.61||0.882|2-Sided|95.0|-1.29|1.11|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687387|NCT01153347|3103632|Superiority or Other||LS mean|1.0|Standard Error of the Mean|0.61||0.097|2-Sided|95.0|-0.18|2.22|||MMRM|||MMRM model includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687388|NCT01153347|3103633|Superiority or Other||LS mean|-0.51|Standard Error of the Mean|0.65||0.433|2-Sided|95.0|-1.787|0.767|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1687389|NCT01153347|3103633|Superiority or Other||LS mean|-0.22|Standard Error of the Mean|0.647||0.738|2-Sided|95.0|-1.487|1.055|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1687390|NCT01153347|3103633|Superiority or Other||LS mean|-0.82|Standard Error of the Mean|0.645||0.202|2-Sided|95.0|-2.091|0.442|||ANCOVA|||An analysis of covariance (ANCOVA) with randomization HAM-A total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1687391|NCT01153347|3103634|Superiority or Other||Odds Ratio (OR)|0.65|Standard Error of the Mean|0.15||0.066|2-Sided|95.0|0.41|1.03|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.|
1687392|NCT01153347|3103634|Superiority or Other||Odds Ratio (OR)|1.06|Standard Error of the Mean|0.24||0.803|2-Sided|95.0|0.67|1.67|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.|
1687393|NCT01153347|3103634|Superiority or Other||Odds Ratio (OR)|0.97|Standard Error of the Mean|0.23||0.908|2-Sided|95.0|0.62|1.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization Clinical Global Impression Severity (CGI-S) as a covariate.|
1687394|NCT01153347|3103635|Superiority or Other||LS mean|0.0|Standard Error of the Mean|0.14||0.78|2-Sided|95.0|-0.23|0.31|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687395|NCT01153347|3103635|Superiority or Other||LS mean|-0.1|Standard Error of the Mean|0.13||0.487|2-Sided|95.0|-0.36|0.17|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687396|NCT01153347|3103635|Superiority or Other||LS mean|-0.1|Standard Error of the Mean|0.13||0.551||95.0|-0.34|0.18|||MMRM|||MMRM model includes treatment, pooled center, visit, and treatment by visit interaction as explanatory variables and the randomization CGI-S total score as a covariate. Treatment, visit, and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687397|NCT01153347|3103636|Superiority or Other||LS mean|-0.4|Standard Error of the Mean|0.78||0.591|2-Sided|95.0|-1.96|1.12|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1687398|NCT01153347|3103636|Superiority or Other||LS mean|-0.6|Standard Error of the Mean|0.78||0.427|2-Sided|95.0|-2.16|0.91|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1687399|NCT01153347|3103636|Superiority or Other||LS mean|-1.0|Standard Error of the Mean|0.78||0.207|2-Sided|95.0|-2.51|0.55|||ANCOVA|||Analysis of covariance (ANCOVA) with randomization HAMD-17 total score as covariate, treatment as a fixed effect and pooled center as a random effect.|
1687400|NCT01153347|3103637|Superiority or Other||Odds Ratio (OR)|0.88|Standard Error of the Mean|0.39||0.763|2-Sided|95.0|0.37|2.08|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687401|NCT01153347|3103637|Superiority or Other||Odds Ratio (OR)|1.57|Standard Error of the Mean|0.62||0.253|2-Sided|95.0|0.72|3.4|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687402|NCT01153347|3103637|Superiority or Other||Odds Ratio (OR)|1.03|Standard Error of the Mean|0.42||0.949|2-Sided|95.0|0.46|2.31|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687403|NCT01153347|3103638|Superiority or Other||Odds Ratio (OR)|0.85|Standard Error of the Mean|0.29||0.633|2-Sided|95.0|0.44|1.64|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687404|NCT01153347|3103638|Superiority or Other||Odds Ratio (OR)|1.22|Standard Error of the Mean|0.38||0.532|2-Sided|95.0|0.66|2.24|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687405|NCT01153347|3103638|Superiority or Other||Odds Ratio (OR)|0.91|Standard Error of the Mean|0.3||0.778|2-Sided|95.0|0.48|1.73|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687406|NCT01153347|3103639|Superiority or Other||Odds Ratio (OR)|0.98|Standard Error of the Mean|0.42||0.958|2-Sided|95.0|0.43|2.25|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687407|NCT01153347|3103639|Superiority or Other||Odds Ratio (OR)|0.93|Standard Error of the Mean|0.39||0.864|2-Sided|95.0|0.41|2.14|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687408|NCT01153347|3103639|Superiority or Other||Odds Ratio (OR)|0.95|Standard Error of the Mean|0.4||0.905|2-Sided|95.0|0.42|2.15|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687409|NCT01153347|3103640|Superiority or Other||Odds Ratio (OR)|0.76|Standard Error of the Mean|0.2||0.308|2-Sided|95.0|0.45|1.29|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687410|NCT01153347|3103640|Superiority or Other||Odds Ratio (OR)|0.89|Standard Error of the Mean|0.23||0.671|2-Sided|95.0|0.53|1.5|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687411|NCT01153347|3103640|Superiority or Other||Odds Ratio (OR)|0.91|Standard Error of the Mean|0.24||0.73|2-Sided|95.0|0.55|1.53|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687412|NCT01153347|3103641|Superiority or Other||Odds Ratio (OR)|0.87|Standard Error of the Mean|0.21||0.544|2-Sided|95.0|0.54|1.38|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687413|NCT01153347|3103641|Superiority or Other||Odds Ratio (OR)|0.9|Standard Error of the Mean|0.21||0.67|2-Sided|95.0|0.57|1.43|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687414|NCT01153347|3103641|Superiority or Other||Odds Ratio (OR)|1.01|Standard Error of the Mean|0.24||0.967|2-Sided|95.0|0.64|1.6|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687415|NCT01153347|3103642|Superiority or Other||LS mean|-0.1|Standard Error of the Mean|1.09||1|2-Sided|95.0|-2.26|2.04|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687416|NCT01153347|3103642|Superiority or Other||LS mean|-0.6|Standard Error of the Mean|1.08||1|2-Sided|95.0|-2.67|1.57|||MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687417|NCT01153347|3103642|Superiority or Other||LS mean|-0.9|Standard Error of the Mean|1.07||1|2-Sided|95.0|-2.96|1.24||The adjusted p-value protects the overall family-wise error rate by taking into account the multiple comparisons between the TC-5214 doses for both the primary efficacy variable (MADRS) and the key secondary efficacy variable (SDS).|MMRM|||Mixed model repeated measures (MMRM) includes treatment, pooled center, visit and treatment by visit interaction as explanatory variables and the randomization MADRS total score as a covariate. Treatment, visit and treatment by visit interaction are fixed effects in the model; pooled center is a random effect.|
1687418|NCT01153009|3103739|Superiority or Other||LS Mean Difference|-1.99|Standard Error of the Mean|1.123||0.078|2-Sided|95.0|-4.19|0.22|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.|||
1687419|NCT01153009|3103739|Superiority or Other||LS Mean Difference|-0.88|Standard Error of the Mean|1.103||0.427|2-Sided|95.0|-3.05|1.29|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.|||
1687420|NCT01153009|3103739|Superiority or Other||LS Mean Difference|-0.05|Standard Error of the Mean|1.111||0.962|2-Sided|95.0|-2.24|2.13|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline SDS total score-by-week as fixed effects.|||
1687421|NCT01153009|3103740|Superiority or Other||Odds Ratio (OR)|1.098||||0.728|2-Sided|95.0|0.648|1.86|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1687422|NCT01153009|3103740|Superiority or Other||Odds Ratio (OR)|1.192||||0.503|2-Sided|95.0|0.713|1.994|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1687423|NCT01153009|3103740|Superiority or Other||Odds Ratio (OR)|1.053||||0.845|2-Sided|95.0|0.625|1.775|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1687424|NCT01153009|3103741|Superiority or Other||LS Mean Difference|-4.05|Standard Error of the Mean|2.278||0.078|2-Sided|95.0|-8.54|0.45|||Mixed model for repeated mesurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.|||
1687425|NCT01153009|3103741|Superiority or Other||LS Mean Difference|-0.62|Standard Error of the Mean|2.419||0.797|2-Sided|95.0|-5.4|4.15|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.|||
1687426|NCT01153009|3103741|Superiority or Other||LS Mean Difference|0.93|Standard Error of the Mean|2.286||0.684|2-Sided|95.0|-3.58|5.45|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.|||
1688108|NCT01143324|3105103|Superiority or Other||Difference from pre-op mean|-3.8|||<|0.0001|2-Sided|95.0|-4.2|-3.3|||t-test, 2 sided||||
1687428|NCT01153009|3103742|Superiority or Other||LS Mean Difference|-0.19|Standard Error of the Mean|0.139||0.177|2-Sided|95.0|-0.46|0.08|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.|||
1687429|NCT01153009|3103742|Superiority or Other||LS Mean Difference|-0.12|Standard Error of the Mean|0.14||0.4|2-Sided|95.0|-0.39|0.16|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline CGI-S score-by-week as fixed effects.|||
1687430|NCT01153009|3103743|Superiority or Other||Odds Ratio (OR)|1.991||||0.004|2-Sided|95.0|1.25|3.171|||Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1687431|NCT01153009|3103743|Superiority or Other||Odds Ratio (OR)|1.257||||0.332|2-Sided|95.0|0.792|1.994||Pre-specified sequential statistical testing procedure indicates that when p-value >0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.|Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1687432|NCT01153009|3103743|Superiority or Other||Odds Ratio (OR)|1.249||||0.348|2-Sided|95.0|0.786|1.984|||Regression, Logistic|P-value is from logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1687433|NCT01153009|3103744|Superiority or Other||LS Mean Difference|-4.1|Standard Error of the Mean|1.21|<|0.001|2-Sided|95.0|-6.46|-1.69|||Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.|||
1687434|NCT01153009|3103744|Superiority or Other||LS Mean Difference|-2.8|Standard Error of the Mean|1.21|<|0.023|2-Sided|95.0|-5.12|-0.38||Pre-specified sequential statistical testing procedure indicates that when p-value <0.025, hierarchical testing continues for this dose.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.|||
1687435|NCT01153009|3103744|Superiority or Other||LS mean difference|-1.5|Standard Error of the Mean|1.21|<|0.224|2-Sided|95.0|-3.86|0.91||Pre-specified sequential statistical testing procedure indicates that when p-value >0.025, hierarchical testing stops for this dose and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|MMRM ANCOVA with treatment, center, week, treatment-by-week interaction, baseline MADRS total score-by-week as fixed effects.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 15 mg and 20 mg vortioxetine to placebo. Efficacy endpoints were tested for each dose in a sequential order at significance level 0.025; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.|
1687436|NCT01152788|3103759|Superiority or Other (legacy)|||||||0.01|||||||Chi-squared||||
1687437|NCT01152788|3103760|Superiority or Other (legacy)||Hazard Ratio (HR)|0.8||||0.55|2-Sided|95.0|0.38|1.68|||Log Rank||||
1687438|NCT01152788|3103761|Superiority or Other (legacy)||Risk Difference (RD)|-1.0|||||2-Sided|95.0|-18.7|16.8|||||||
1687439|NCT01152788|3103762|Superiority or Other (legacy)||Hazard Ratio (HR)|1.1||||0.76|2-Sided|95.0|0.6|2.01|||Log Rank||||
1687440|NCT01152554|3103795|Superiority or Other||Odds Ratio (OR)|0.84|Standard Error of the Mean|0.27||0.582|2-Sided|95.0|0.45|1.57|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687441|NCT01152554|3103796|Superiority or Other||Odds Ratio (OR)|0.9|Standard Error of the Mean|0.24||0.697|2-Sided|95.0|0.54|1.5|||Regression, Logistic||TC-5214 is the numerator in the OR, OR>1 represents a result in favor of TC-5214.|Logistic regression model including treatment and pooled center as fixed effects and the randomization MADRS total score as a covariate.|
1687442|NCT01152450|3103805|Superiority or Other||Mean Difference (Final Values)|0.002|Standard Error of the Mean|0.031||||95.0|-0.059|0.063|||||Tio R5 qd - Tio R2.5 bid||
1687443|NCT01152450|3103805|Superiority or Other||Mean Difference (Final Values)|0.003|Standard Error of the Mean|0.031||0.9102||95.0|-0.058|0.065|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687444|NCT01152450|3103805|Superiority or Other||Mean Difference (Final Values)|0.001|Standard Error of the Mean|0.031||0.9626||95.0|-0.059|0.062|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687445|NCT01152450|3103806|Superiority or Other||Mean Difference (Final Values)|-0.013|Standard Error of the Mean|0.074||||95.0|-0.16|0.134|||||Tio R5 qd - Tio R2.5 bid||
1687446|NCT01152450|3103806|Superiority or Other||Mean Difference (Final Values)|-0.074|Standard Error of the Mean|0.074||0.3185||95.0|-0.221|0.072|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687447|NCT01152450|3103806|Superiority or Other||Mean Difference (Final Values)|-0.061|Standard Error of the Mean|0.074||0.4089||95.0|-0.207|0.085|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687448|NCT01152450|3103807|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.082||||95.0|-0.222|0.102|||||Tio R5 qd - Tio R2.5 bid||
1687449|NCT01152450|3103807|Superiority or Other||Mean Difference (Final Values)|-0.062|Standard Error of the Mean|0.082||0.4518||95.0|-0.223|0.1|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687450|NCT01152450|3103807|Superiority or Other||Mean Difference (Final Values)|-0.002|Standard Error of the Mean|0.082||0.9797||95.0|-0.163|0.159|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687451|NCT01152450|3103808|Superiority or Other||Mean Difference (Final Values)|-0.099|Standard Error of the Mean|0.143||||95.0|-0.382|0.184|||||Tio R5 qd - Tio R2.5 bid||
1687452|NCT01152450|3103808|Superiority or Other||Mean Difference (Final Values)|-0.176|Standard Error of the Mean|0.143||0.2208||95.0|-0.458|0.106|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687453|NCT01152450|3103808|Superiority or Other||Mean Difference (Final Values)|-0.077|Standard Error of the Mean|0.142||0.5906||95.0|-0.358|0.204|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687456|NCT01152450|3103809|Superiority or Other||Mean Difference (Final Values)|0.323|Standard Error of the Mean|0.769||0.6747||95.0|-1.195|1.841|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687457|NCT01152450|3103810|Superiority or Other||Mean Difference (Final Values)|4.068|Standard Error of the Mean|4.094||||95.0|-4.012|12.148|||||Tio R5 qd - Tio R2.5 bid||
1687458|NCT01152450|3103810|Superiority or Other||Mean Difference (Final Values)|34.31|Standard Error of the Mean|4.089|<|0.0001||95.0|26.24|42.38|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687459|NCT01152450|3103810|Superiority or Other||Mean Difference (Final Values)|30.242|Standard Error of the Mean|4.091|<|0.0001||95.0|22.167|38.317|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687460|NCT01152450|3103811|Superiority or Other||Mean Difference (Final Values)|-0.016|Standard Error of the Mean|0.023||||95.0|-0.063|0.03|||||Tio R5 qd - Tio R2.5 bid||
1687461|NCT01152450|3103811|Superiority or Other||Mean Difference (Final Values)|0.084|Standard Error of the Mean|0.023||0.0004||95.0|0.038|0.13|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687462|NCT01152450|3103811|Superiority or Other||Mean Difference (Final Values)|0.101|Standard Error of the Mean|0.023|<|0.0001||95.0|0.055|0.147|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687463|NCT01152450|3103815|Superiority or Other||Mean Difference (Final Values)|-0.029|Standard Error of the Mean|0.027||||95.0|-0.082|0.023|||||Tio R5 qd - Tio R2.5 bid||
1687464|NCT01152450|3103815|Superiority or Other||Mean Difference (Final Values)|0.048|Standard Error of the Mean|0.027||0.0747||95.0|-0.005|0.1|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687465|NCT01152450|3103815|Superiority or Other||Mean Difference (Final Values)|0.077|Standard Error of the Mean|0.027||0.0042||95.0|0.025|0.13|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687466|NCT01152450|3103816|Superiority or Other||Mean Difference (Final Values)|-0.008|Standard Error of the Mean|0.027||||95.0|-0.061|0.045|||||Tio R5 qd - Tio R2.5 bid||
1687467|NCT01152450|3103816|Superiority or Other||Mean Difference (Final Values)|0.068|Standard Error of the Mean|0.027||0.0123||95.0|0.015|0.12|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687468|NCT01152450|3103816|Superiority or Other||Mean Difference (Final Values)|0.076|Standard Error of the Mean|0.027||0.0051||95.0|0.023|0.129|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687469|NCT01152450|3103817|Superiority or Other||Mean Difference (Final Values)|-0.025|Standard Error of the Mean|0.026||||95.0|-0.077|0.027|||||Tio R5 qd - Tio R2.5 bid||
1687470|NCT01152450|3103817|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.026||0.0002||95.0|0.048|0.152|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687471|NCT01152450|3103817|Superiority or Other||Mean Difference (Final Values)|0.125|Standard Error of the Mean|0.026|<|0.0001||95.0|0.073|0.177|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687472|NCT01152450|3103818|Superiority or Other||Mean Difference (Final Values)|-0.012|Standard Error of the Mean|0.035||||95.0|-0.08|0.057|||||Tio R5 qd - Tio R2.5 bid||
1687473|NCT01152450|3103818|Superiority or Other||Mean Difference (Final Values)|0.056|Standard Error of the Mean|0.035||0.1058||95.0|-0.012|0.124|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687474|NCT01152450|3103818|Superiority or Other||Mean Difference (Final Values)|0.068|Standard Error of the Mean|0.035||0.0515||95.0|0.0|0.136|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687475|NCT01152450|3103819|Superiority or Other||Mean Difference (Final Values)|0.021|Standard Error of the Mean|0.03||||95.0|-0.037|0.08|||||Tio R5 qd - Tio R2.5 bid||
1687476|NCT01152450|3103819|Superiority or Other||Mean Difference (Final Values)|0.133|Standard Error of the Mean|0.029|<|0.0001||95.0|0.074|0.191|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687477|NCT01152450|3103819|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|0.03|<|0.0002||95.0|0.053|0.17|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687478|NCT01152450|3103820|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.024||||95.0|-0.048|0.047|||||Tio R5 qd - Tio R2.5 bid||
1687479|NCT01152450|3103820|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687480|NCT01152450|3103820|Superiority or Other||Mean Difference (Final Values)|0.132|Standard Error of the Mean|0.024|<|0.0001||95.0|0.084|0.179|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687481|NCT01152450|3103821|Superiority or Other||Mean Difference (Final Values)|0.002|Standard Error of the Mean|0.026||||95.0|-0.05|0.054|||||Tio R5 qd - Tio R2.5 bid||
1687482|NCT01152450|3103821|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.026|<|0.0001||95.0|0.079|0.183|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687483|NCT01152450|3103821|Superiority or Other||Mean Difference (Final Values)|0.129|Standard Error of the Mean|0.026|<|0.0001||95.0|0.077|0.181|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687484|NCT01152450|3103822|Superiority or Other||Mean Difference (Final Values)|0.016|Standard Error of the Mean|0.025||||95.0|-0.033|0.065|||||Tio R5 qd - Tio R2.5 bid||
1687485|NCT01152450|3103822|Superiority or Other||Mean Difference (Final Values)|0.185|Standard Error of the Mean|0.025|<|0.0001||95.0|0.136|0.234|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687486|NCT01152450|3103822|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.025|<|0.0001||95.0|0.12|0.218|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687487|NCT01152450|3103823|Superiority or Other||Mean Difference (Final Values)|-1.264|Standard Error of the Mean|5.056||||95.0|-11.243|8.716|||||Tio R5 qd - Tio R2.5 bid||
1687488|NCT01152450|3103823|Superiority or Other||Mean Difference (Final Values)|28.657|Standard Error of the Mean|5.042|<|0.0001||95.0|18.707|38.606|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687489|NCT01152450|3103823|Superiority or Other||Mean Difference (Final Values)|29.92|Standard Error of the Mean|5.026|<|0.0001||95.0|20.001|39.839|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687490|NCT01152450|3103824|Superiority or Other||Mean Difference (Final Values)|1.029|Standard Error of the Mean|5.242||||95.0|-9.318|11.376|||||Tio R5 qd - Tio R2.5 bid||
1687491|NCT01152450|3103824|Superiority or Other||Mean Difference (Final Values)|22.357|Standard Error of the Mean|5.225|<|0.0001||95.0|12.044|32.67|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687492|NCT01152450|3103824|Superiority or Other||Mean Difference (Final Values)|21.328|Standard Error of the Mean|5.19|<|0.0001||95.0|11.084|31.573|||Mixed Models Analysis|MMRM adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687493|NCT01152450|3103825|Superiority or Other||Mean Difference (Final Values)|0.009|Standard Error of the Mean|0.024||||95.0|-0.038|0.056|||||Tio R5 qd - Tio R2.5 bid||
1687494|NCT01152450|3103825|Superiority or Other||Mean Difference (Final Values)|0.158|Standard Error of the Mean|0.024|<|0.0001||95.0|0.111|0.205|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R5 qd - Placebo||
1687495|NCT01152450|3103825|Superiority or Other||Mean Difference (Final Values)|0.149|Standard Error of the Mean|0.024|<|0.0001||95.0|0.102|0.196|||Mixed Models Analysis|MMRM, adjusted for treatment, period, patient and study baseline.|Tio R2.5 bid - Placebo||
1687496|NCT01152437|3103829|Superiority or Other||Percentage of participants|12.0||||0.6394|2-Sided|90.0|4.9|23.9||The statistical analysis is descriptive and exploratory in nature and performed only to provide a statistical framework from which to view the results and plan further studies.|Exact binomial test|||Null hypothesis is that the disease control rate is 10% in patients with KRAS mutation. Sample size calculation based on a 2-sided exact binomial test at 10% significance level to distinguish between the historical disease control rate of 10% and a desirable disease control rate for afatinib of 25%.|
1687497|NCT01152437|3103830|Superiority or Other||Odds Ratio (OR)|0.122||||0.0735|2-Sided|90.0|0.018|0.844||The statistical analysis is descriptive and exploratory in nature and performed only to provide a statistical framework from which to view the results and plan further studies.|Regression, Logistic|Wald Chi-square test and Confidence Interval from logistic regression stratified by number of lines of palliative chemotherapy.||Null hypothesis is that the objective response rate (ORR) in KRAS wild-type patients treated with afatinib is less than or equal to the ORR in KRAS wild-type patients treated with cetuximab. Sample size is based on a 'pick the winner' approach assuming ORR for cetuximab of 12%, undesirable ORR for afatinib of 11% and desirable ORR for afatinib of 16%. As per 'pick the winner' approach, afatinib would be considered 'the winner' if the ORR for afatinib was greater than the ORR for cetuximab.|
1687498|NCT01152359|3103839|Superiority||Mean Difference (Net)|-0.8||||0.65|2-Sided|95.0|-4.1|2.6|||Mixed Models Analysis||||
1687499|NCT01152359|3103840|Superiority||Mean Difference (Final Values)|-0.9||||0.66|2-Sided|95.0|-4.9|3.1|||Mixed Models Analysis||||
1687500|NCT01152359|3103841|Superiority||Mean Difference (Final Values)|1.1|||<|0.05|2-Sided|95.0|-0.8|2.9|||Mixed Models Analysis||||
1687501|NCT01152307|3103843|Superiority or Other||Mean Difference (Net)|3.42|Standard Deviation|1.6||0.01|2-Sided|95.0|0.76|6.09|||t-test, 2 sided|||We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.|
1687502|NCT01152294|3103845|Superiority or Other||Mean Difference (Net)|4.6|Standard Deviation|2.4||0.01|2-Sided|95.0|1.02|7.96|||t-test, 2 sided|||We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.|
1687503|NCT01152190|3103846|Superiority or Other||Difference in LS Means|7.93|Standard Error of the Mean|5.199||0.131||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the bladder neck CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures||||
1687504|NCT01152190|3103846|Superiority or Other||Difference in LS Means|-4.2|Standard Error of the Mean|5.77||0.468||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the bladder neck CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures||||
1687505|NCT01152190|3103846|Superiority or Other||Difference in LS Means|-0.55|Standard Error of the Mean|2.729||0.839||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate peripheral zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures||||
1687506|NCT01152190|3103846|Superiority or Other||Difference in LS Means|3.47|Standard Error of the Mean|2.937||0.24||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate peripheral zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures||||
1687507|NCT01152190|3103846|Superiority or Other||Difference in LS Means|0.51|Standard Error of the Mean|2.867||0.86||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate transition zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures||||
1687508|NCT01152190|3103846|Superiority or Other||Difference in LS Means|2.63|Standard Error of the Mean|3.38||0.439||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate transition zone CPI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures||||
1687509|NCT01152190|3103847|Superiority or Other||Difference in LS Means|0.01|Standard Error of the Mean|0.022||0.625||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in bladder neck RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures||||
1687510|NCT01152190|3103847|Superiority or Other||Difference in LS Means|0.02|Standard Error of the Mean|0.017||0.195||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in bladder neck RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures||||
1687511|NCT01152190|3103847|Superiority or Other||Difference in LS Means|0.02|Standard Error of the Mean|0.009||0.066||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 in the prostate peripheral zone RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures||||
1687512|NCT01152190|3103847|Superiority or Other||Difference in LS Means|0.01|Standard Error of the Mean|0.009||0.208||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 in the prostate peripheral zone RI was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures||||
1687513|NCT01152190|3103848|Superiority or Other||Difference in LS Means|0.01|Standard Error of the Mean|0.008||0.226||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 4 between the tadalafil and placebo treatment groups was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures||||
1687514|NCT01152190|3103849|Superiority or Other||Difference in LS Means|0.01|Standard Error of the Mean|0.009||0.121||95.0||||The p-value associated with the LS mean difference of change from baseline to Week 8 between the tadalafil and placebo treatment groups was tested at a significance level of 0.05 with no adjustments for multiplicity.|Mixed-Model Repeated Measures||||
1687515|NCT01151761|3103866|Superiority or Other||proportion of participants|0.0|||||2-Sided||||||||None of the two patients who participated had a local recurrence before they died.||
1687516|NCT01151761|3103871|Superiority or Other||months|8.5|||||2-Sided|95.0|7.0|10.0|||||There were only two patients in the study. Both died without having any local failure. One patient died at 10 months, the other at 7 months. The range for the 95%CI is both the full range and the 95%CI.|The median Progression Free Survival (PFS) time as calculated using Kaplan Meier methodology. For PFS both death and progression are counted as events.|
1687517|NCT01151618|3103874|Other|"Sensitivity and Specificity of values with respect to the Mead Whittenberger method were computed as follows (FL=flow limited and NFL = Non Flow limited):~Sensitivity = (# of FL breaths detected by FOT / # of FL breaths detected by M&W) * 100 Specificity =(# of NFL breaths detected by FOT / # of NFL breaths detected by M&W) * 100"|DeltaXrs (cmH2O*s/L)|2.6|||||2-Sided|90.0|0.0|100.0|||||DeltaXrs equals average inspiratory reactance minus average expiratory reactance.||
1687518|NCT01151579|3103875|Superiority or Other|||||||0|||||||descriptive|Descriptive statistics (frequency) used to report the number of participants experiencing an event.||To report on the number of events.|
1687519|NCT01151579|3103876|Superiority or Other||Risk Ratio (RR)|1.0||||0.05|2-Sided|95.0||||Analysis adjusted with Fischer exact chi-square for rare occurrences.|Chi-squared|||Null hypothesis: no difference in incidence of arrhythmias between groups within the total number of breathing treatments.|
1687520|NCT01151579|3103877|Non-Inferiority or Equivalence|A total of at least 400 treatemnts or 65 patients was required to achieve 94% power to determine a 1% change by treatment or a 5% change between groups to be significant at p-value of 0.01 and o.05, respectively.|Mean Difference (Final Values)|1.0|Standard Error of the Mean|0.5||0.01|2-Sided|95.0|||||Mixed Models Analysis|||Null Hypothesis: No difference between groups in heart rate changes from baseline following treatment. Sample size calculation determined a need for at least 400 breathing treatments among 65 patients.|
1687521|NCT01151423|3103937|Superiority||Hazard Ratio (HR)|2.2|||=|0|2-Sided|95.0|1.28|3.78||Caplacizumab was compared to placebo using a one-sided log-rank test in order to assess superiority at 2.5% significance level.|Stratified log-rank test||The HR was estimated from a Cox proportional Hazards regression model with presence (yes) / absence (no) of 1 PE session prior to randomization as covariate.|The primary analysis consisted of a Kaplan-Meier analysis with time-to-response as endpoint and treatment group as the independent variable and stratified for absence/presence of one PE session prior to randomization.|
1687522|NCT01151410|3103940|Non-Inferiority or Equivalence|Indicates statistical significance at 0.025 level for one sided non-inferiority testing at 4mmHg margin.|Mean Difference (Net)|0.31||||0.004|1-Sided|95.0|-2.4||||ANCOVA||||
1687523|NCT01151345|3103955|Superiority or Other||Adjusted geometric means ratio|83.25|||||2-Sided|90.0|67.08|103.31||||||Natural-log transformed Cmax was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.|
1687524|NCT01151345|3103956|Superiority or Other||Adjusted geometric means ratio|91.26|||||2-Sided|90.0|83.83|99.34||||||Natural-log transformed AUC (0-∞) was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.|
1687525|NCT01151345|3103957|Superiority or Other||Adjusted geometric means ratio|88.65|||||2-Sided|90.0|81.23|96.75||||||Natural-log transformed AUC (0-t) was analyzed using a mixed effect model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.|
1687526|NCT01151215|3103966|Superiority or Other||Hazard Ratio (HR)|1.37||||0.135|2-Sided|95.0|0.91|2.06|||Log Rank|The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)|The Hazard ratio is for AZD8931 20mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio < 1 favours AZD8931 20mg + anastrozole 1mg|345 patients were to be randomised to observe at least 233 progression events, based on HR=0.6, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.|
1687527|NCT01151215|3103966|Superiority or Other||Hazard Ratio (HR)|1.16||||0.485|2-Sided|95.0|0.77|1.75||Statistical significance threshold at this interim analysis was 5%|Log Rank|The log rank test was stratified for the IVRS stratification factor of disease classification (locally advanced / metastatic disease)|The Hazard Ratio is for AZD8931 40mg + anastrozole 1mg / Placebo + anastrozole 1mg, ie a hazard ratio <1 favours AZD8931 40mg + anastrozole 1mg|345 patients were to be randomised to observe at least 233 progression events, based on HR=0.60, 90% power, 2-sided 5% significant level and a median of 9 months for the placebo arm. An interim analysis with futility boundary was introduced based on an IDMC recommendation.|
1688109|NCT01143324|3105104|Superiority or Other||Difference from pre-op mean|-3.3|||<|0.0001|2-Sided|95.0|-3.6|-2.9|||t-test, 2 sided||||
1687528|NCT01151137|3103978|Superiority or Other||Hazard Ratio (HR)|2.115||||0.046|2-Sided|95.0|0.996|4.49||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for cardiovascular death~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.|
1687529|NCT01151137|3103980|Superiority or Other||Hazard Ratio (HR)|1.947|||<|0.0001|2-Sided|95.0|1.448|2.617||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank's asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for unscheduled cardiovascular hospitalization or death from any cause~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.|
1687530|NCT01151137|3103981|Superiority or Other||Hazard Ratio (HR)|2.294||||0.0019|2-Sided|95.0|1.337|3.936||A priori threshold for statistical significance: 0.05|Log Rank|2-sided Log-rank’s asymptotic test|"Hazard ratio (HR) of Dronedarone versus placebo for stroke, systemic arterial embolism, myocardial infarction or cardiovascular death~HR and confidence interval were estimated using Cox regression model with treatment group as the only factor."|As a consequence of the early termination of the study, the analysis was performed for information only without any adjustment.|
1687531|NCT01151085|3103984|Superiority or Other||||||<|0.001|||||||Chi-squared|||Statistical Analysis for Risk Factors for the Proportion of Responders to Voriconazole treatment -Severity of infections.|
1687532|NCT01151085|3103985|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Past History. The null hypothesis is there is no difference between with and without Past History in the Frequency of Treatment Related Adverse Events."|
1687533|NCT01151085|3103986|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Severity of infections. The null hypothesis is there is no difference among mild, moderate and severe in the Frequency of Treatment Related Adverse Events."|
1687534|NCT01151085|3103987|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between Male and Female  in the Frequency of Treatment Related Adverse Events."|
1687535|NCT01151046|3103992|Superiority or Other||Hazard Ratio (HR)|1.41||||0.349|2-Sided|95.0|0.69|2.88|||Log Rank||||
1687536|NCT01151046|3103992|Superiority or Other||Hazard Ratio (HR)|0.26||||0.003|2-Sided|95.0|0.11|0.63|||Log Rank||||
1687537|NCT01151020|3103994|Superiority or Other||Device success rate (%)|92.7|||<|0.001|2-Sided|95.0|86.2|96.8|||Exact binomial test|||Null Hypothesis: The 12-month device success for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.7%.|
1687538|NCT01151020|3103995|Superiority or Other||Free from major adverse event rate (%)|96.4|||<|0.001|2-Sided|95.0|91.0|99.0|||Exact binomial test|||Null hypothesis: The 30-day freedom from MAE for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.6%.|
1687539|NCT01150903|3104004|Superiority or Other||||||<|0.001|||||||Chi-squared|||Chi-square test was used to calculate p-value.|
1687540|NCT01150903|3104005|Superiority or Other||||||<|0.001|||||||Chi-squared|||Chi-square test was used to calculate p-value.|
1687541|NCT01150760|3104006|Superiority or Other||Mean Difference (Net)|-0.3|||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1687542|NCT01150760|3104007|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1687543|NCT01150760|3104008|Superiority or Other||Mean Difference (Net)|-1.9||||0.0532|||||||Chi-squared||||
1687544|NCT01150760|3104009|Superiority or Other||Mean Difference (Net)|-0.6||||0.0755|||||||Chi-squared||||
1687545|NCT01150760|3104010|Superiority or Other||Mean Difference (Net)|-1.3||||0.0402|||||||Chi-squared||||
1687546|NCT01150760|3104011|Superiority or Other||Mean Difference (Net)|-0.1||||0.7637|||||||Chi-squared||||
1687547|NCT01150760|3104012|Superiority or Other||Mean Difference (Net)|-0.9||||0.003|||||||Chi-squared||||
1687548|NCT01150760|3104013|Superiority or Other||Mean Difference (Net)|-2.3||||0.0012|||||||Chi-squared||||
1687549|NCT01150760|3104014|Superiority or Other||Mean Difference (Net)|-1.1|||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1687550|NCT01150760|3104015|Superiority or Other||Mean Difference (Net)|-3.2|||<|0.0001|||||||Chi-squared||||
1687551|NCT01150760|3104016|Superiority or Other||Mean Difference (Net)|-0.3||||0.1022|||||||Chi-squared||||
1687552|NCT01150760|3104017|Superiority or Other||Mean Difference (Net)|-4.6||||0.0001|||||||Chi-squared||||
1687553|NCT01150760|3104018|Superiority or Other||Mean Difference (Net)|-5.9|||<|0.0001|||||||Chi-squared||||
1687554|NCT01150760|3104019|Superiority or Other||Mean Difference (Net)|-0.6||||0.0007|||||||Chi-squared||||
1687555|NCT01150474|3104027|Superiority or Other|||||||0.59|||||||t-test, 2 sided||||
1687556|NCT01150474|3104028|Superiority or Other|||||||0.55|||||||t-test, 2 sided||||
1687557|NCT01150474|3104029|Superiority or Other|||||||0.83|||||||t-test, 2 sided||||
1687558|NCT01150474|3104030|Superiority or Other|||||||0.14|||||||t-test, 2 sided||||
1687559|NCT01150474|3104031|Superiority or Other|||||||0.3|||||||t-test, 2 sided||||
1687560|NCT01150474|3104032|Superiority or Other|||||||0.43|||||||t-test, 2 sided||||
1687561|NCT01150474|3104033|Superiority or Other|||||||0.07|||||||t-test, 2 sided||||
1687562|NCT01150474|3104034|Superiority or Other|||||||0.75|||||||t-test, 2 sided||||
1687563|NCT01150474|3104035|Superiority or Other|||||||0.82|||||||t-test, 2 sided||||
1687564|NCT01150461|3104036|Superiority or Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test|
1687565|NCT01150461|3104037|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test|
1687566|NCT01149876|3104073|Superiority or Other|||||||0.48|||||||t-test, 2 sided||||
1687567|NCT01149876|3104073|Superiority or Other|||||||0.25|||||||t-test, 2 sided||||
1687568|NCT01149876|3104073|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1688110|NCT01143324|3105105|Superiority or Other||Mean|1.3|Standard Deviation|0.5|||2-Sided|95.0|1.2|1.3|||||||
1687569|NCT01149785|3104079|Superiority or Other||Ratio of Adjusted Means|161.42|||||2-Sided|90.0|143.09|182.09||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687570|NCT01149785|3104081|Superiority or Other||Ratio of Adjusted Means|516.98|||||2-Sided|90.0|457.88|583.72||||||Natural log transformed AUC (0-∞) of crizotinib metabolite (PF-06260182) was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687571|NCT01149785|3104082|Superiority or Other||Ratio of Adjusted Means|519.65|||||2-Sided|90.0|460.42|586.5||||||Natural log transformed AUClast of crizotinib metabolite (PF-06260182) was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687572|NCT01149785|3104085|Superiority or Other||Ratio of Adjusted Means|144.13|||||2-Sided|90.0|126.42|164.33||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687573|NCT01149785|3104088|Superiority or Other||Ratio of Adjusted Means|328.31|||||2-Sided|90.0|296.42|363.63||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687574|NCT01149785|3104089|Superiority or Other||Ratio of Adjusted Means|316.36|||||2-Sided|90.0|286.17|349.73||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with treatment as fixed effect and subject as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687575|NCT01149733|3104098|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|90.64|||||2-Sided|90.0|86.59|94.89|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.||
1687576|NCT01149733|3104099|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|91.81|||||2-Sided|90.0|87.72|96.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.||
1687577|NCT01149733|3104100|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Geometric Means|97.9|||||2-Sided|90.0|91.0|105.32|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.||
1687578|NCT01149655|3104104|Superiority or Other|||||||0.0657|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 52. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687579|NCT01149655|3104104|Superiority or Other|||||||0.0706|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 50. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687580|NCT01149655|3104104|Superiority or Other|||||||0.0893|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 48. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687581|NCT01149655|3104104|Superiority or Other|||||||0.0737|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 46. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687582|NCT01149655|3104104|Superiority or Other|||||||0.0686|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 44. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687583|NCT01149655|3104104|Superiority or Other|||||||0.0824|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 42. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1688621|NCT01131260|3106484|Superiority or Other||Risk Ratio (RR)|1.57||||0.07|2-Sided|95.0|0.97|2.54|||Chi-squared||||
1687584|NCT01149655|3104104|Superiority or Other|||||||0.0833|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 40. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687585|NCT01149655|3104104|Superiority or Other|||||||0.0686|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 38. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687586|NCT01149655|3104104|Superiority or Other|||||||0.0898|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 36. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687587|NCT01149655|3104104|Superiority or Other|||||||0.0791|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 34. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687588|NCT01149655|3104104|Superiority or Other|||||||0.0507|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 32. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687589|NCT01149655|3104104|Superiority or Other|||||||0.0337|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 30. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687590|NCT01149655|3104104|Superiority or Other|||||||0.0232|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 28. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687591|NCT01149655|3104104|Superiority or Other|||||||0.0118|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 26. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687592|NCT01149655|3104104|Superiority or Other|||||||0.0107|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 24. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687593|NCT01149655|3104104|Superiority or Other|||||||0.0175|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 22. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687594|NCT01149655|3104104|Superiority or Other|||||||0.0065|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 20. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687595|NCT01149655|3104104|Superiority or Other|||||||0.0076|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 18. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687596|NCT01149655|3104104|Superiority or Other|||||||0.0059|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 16. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687597|NCT01149655|3104104|Superiority or Other|||||||0.0135|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 14. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687598|NCT01149655|3104104|Superiority or Other|||||||0.0274|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 12. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687599|NCT01149655|3104104|Superiority or Other|||||||0.0228|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 10. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687600|NCT01149655|3104104|Superiority or Other|||||||0.0883|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 8. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687647|NCT01149421|3104165|Superiority or Other||Mean Difference (Final Values)|-1.61||||0.004|2-Sided|95.0|-2.72|-0.51||Treatment comparison of mean nighttime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis||||
1687601|NCT01149655|3104104|Superiority or Other|||||||0.2985|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 6. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687602|NCT01149655|3104104|Superiority or Other|||||||0.9723|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 4. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687603|NCT01149655|3104104|Superiority or Other|||||||0.3689|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 3. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687604|NCT01149655|3104104|Superiority or Other|||||||0.8189|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 2. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687605|NCT01149655|3104104|Superiority or Other|||||||0.8861|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis for Week 1. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687606|NCT01149655|3104104|Superiority or Other|||||||0.3862|||||||Cochran-Mantel-Haenszel|CMH method was based on raw mean score statistics.||Statistical analysis at Baseline. The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687607|NCT01149655|3104107|Superiority or Other|||||||0.0076|||||||Log Rank|p-value was derived from the log-rank tests.||The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687608|NCT01149655|3104108|Superiority or Other|||||||0.9025|||||||Chi-squared|p-value was derived using Chi-square test.||The expected total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687609|NCT01149655|3104109|Superiority or Other|||||||0.0962|||||||Chi-squared|p-value was derived using Chi-square test.||Statistical Analysis for Last Visit. The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687610|NCT01149655|3104111|Superiority or Other||Cox Proportional Hazard|0.461||||0.0161|2-Sided|95.0|0.242|0.879|||Log Rank|The log-rank test was based on time to exacerbation of psychotic symptoms/impending relapse.|Hazard ratios and their 95% confidence intervals were derived from the Cox Proportional Hazard model with treatment as term. Hazard ratio < 1 is in favor of oral aripiprazole 10-30 mg group for superiority test.|The total number of exacerbation of psychotic symptoms/impending relapse was estimated using a 2:1 (aripiprazole:placebo) randomization ratio to achieve at least 80% power and to preserve an overall nominal alpha level of 0.05 (2-sided).|
1687611|NCT01149616|3104112|Superiority|||||||0.05||||||P value was calculated, and threshold for significance calculated at less than or equal to 0.05|ANOVA||||
1687612|NCT01149616|3104113|Superiority|||||||0.006|||||||ANOVA||||
1687613|NCT01149616|3104114|Superiority|||||||0.007|||||||ANOVA||||
1687614|NCT01149486|3104122|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.3|||||2-Sided|90.0|98.72|106.01|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1687615|NCT01149486|3104123|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.37|||||2-Sided|90.0|98.75|106.14|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1687616|NCT01149486|3104124|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.78|||||2-Sided|90.0|98.96|115.23|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1687617|NCT01149486|3104125|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.55|||||2-Sided|90.0|99.64|111.82|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1687648|NCT01149421|3104165|Superiority or Other||Mean Difference (Final Values)|-2.74|||<|0.001|2-Sided|95.0|-3.86|-1.62||Treatment comparison of mean nighttime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis||||
1687618|NCT01149486|3104126|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.8|||||2-Sided|90.0|99.58|112.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1687619|NCT01149486|3104127|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|111.62|||||2-Sided|90.0|101.47|122.79|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1687620|NCT01149486|3104128|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.4|||||2-Sided|90.0|93.1|106.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1687621|NCT01149486|3104129|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.45|||||2-Sided|90.0|93.15|106.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1687622|NCT01149486|3104130|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|93.45|||||2-Sided|90.0|80.2|108.88|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1687623|NCT01149473|3104131|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||2-Sided|90.0|98.7|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1687624|NCT01149473|3104132|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|99.7|||||2-Sided|95.0|98.6|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1687625|NCT01149473|3104133|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.0|||||2-Sided|90.0|98.8|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1687626|NCT01149473|3104134|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|101.0|||||2-Sided|90.0|98.6|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1687627|NCT01149473|3104135|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|102.0|||||2-Sided|90.0|98.8|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1687649|NCT01149421|3104165|Superiority or Other||Mean Difference (Final Values)|-0.93|||<|0.113|2-Sided|95.0|-2.09|0.22||Treatment comparison of mean nighttime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis||||
1687650|NCT01149421|3104165|Superiority or Other||Mean Difference (Final Values)|-2.25|||<|0.001|2-Sided|95.0|-3.43|-1.07||Treatment comparison of mean nighttime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis||||
1688622|NCT01131260|3106485|Superiority or Other||Risk Ratio (RR)|0.37||||0.13|2-Sided|95.0|0.1|1.41|||Chi-squared||||
1687628|NCT01149473|3104136|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|109.0|||||2-Sided|90.0|98.1|120.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1687629|NCT01149460|3104137|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means|99.1|||||2-Sided|90.0|97.04|101.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.||
1687630|NCT01149460|3104138|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|99.2|||||2-Sided|90.0|97.14|101.31|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.||
1687631|NCT01149460|3104139|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|103.48|||||2-Sided|90.0|97.87|109.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.||
1687632|NCT01149460|3104140|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|100.01|||||2-Sided|90.0|96.38|103.78|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.||
1687633|NCT01149460|3104141|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|100.01|||||2-Sided|90.0|96.34|103.82|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.||
1687634|NCT01149460|3104142|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of Least Squares Means (T/R)|111.34|||||2-Sided|90.0|100.54|123.29|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the test (T) and reference (R) product fall within the interval of 80-125%.||
1687635|NCT01149421|3104151|Superiority or Other|||||||0.012||||||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1687636|NCT01149421|3104151|Superiority or Other||||||<|0.001||||||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1687637|NCT01149421|3104151|Superiority or Other||||||<|0.005||||||Treatment comparison at 16 weeks.|Mixed Models Analysis||||
1687638|NCT01149421|3104151|Superiority or Other||||||<|0.001||||||Treatment comparison at 16 weeks.|Mixed Models Analysis||||
1687639|NCT01149421|3104164|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.728|2-Sided|95.0|-1.72|1.2||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis||||
1687640|NCT01149421|3104164|Superiority or Other||Mean Difference (Final Values)|-0.46||||0.543|2-Sided|95.0|-1.95|1.03||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis||||
1687641|NCT01149421|3104164|Superiority or Other||Mean Difference (Final Values)|0.52||||0.471|2-Sided|95.0|-0.9|1.95||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis||||
1687642|NCT01149421|3104164|Superiority or Other||Mean Difference (Final Values)|0.31||||0.671|2-Sided|95.0|-1.13|1.76||Treatment comparison of mean nighttime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis||||
1687643|NCT01149421|3104164|Superiority or Other||Mean Difference (Final Values)|-0.47||||0.463|2-Sided|95.0|-1.72|0.79||Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis||||
1687644|NCT01149421|3104164|Superiority or Other||Mean Difference (Final Values)|-0.56||||0.39|2-Sided|95.0|-1.84|0.72||Treatment comparison of mean daytime mean arterial pressure (MAP) at 26 weeks.|Mixed Models Analysis||||
1687645|NCT01149421|3104164|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.883|2-Sided|95.0|-1.32|1.13||Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis||||
1687646|NCT01149421|3104164|Superiority or Other||Mean Difference (Final Values)|-0.97||||0.128|2-Sided|95.0|-2.22|0.28||Treatment comparison of mean daytime mean arterial pressure (MAP) at 16 weeks.|Mixed Models Analysis||||
1688623|NCT01131260|3106486|Superiority or Other||Risk Ratio (RR)|0.76||||1|2-Sided|95.0|0.17|3.38|||Fisher Exact||||
1687651|NCT01149421|3104165|Superiority or Other||Mean Difference (Final Values)|-2.13|||<|0.001|2-Sided|95.0|-3.23|-1.03||Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis||||
1687652|NCT01149421|3104165|Superiority or Other||Mean Difference (Final Values)|-3.4|||<|0.001|2-Sided|95.0|-4.52|-2.28||Treatment comparison of mean daytime pulse pressure (PP) at 26 weeks.|Mixed Models Analysis||||
1687653|NCT01149421|3104165|Superiority or Other||Mean Difference (Final Values)|-1.77|||<|0.001|2-Sided|95.0|-2.79|-0.75||Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis||||
1687654|NCT01149421|3104165|Superiority or Other||Mean Difference (Final Values)|-3.47|||<|0.001|2-Sided|95.0|-4.5|-2.43||Treatment comparison of mean daytime pulse pressure (PP) at 16 weeks.|Mixed Models Analysis||||
1687655|NCT01149421|3104166|Superiority or Other|||||||0.005||||||Treatment comparison of mean clinic heart rate (HR) at 26 weeks.|Mixed Models Analysis||||
1687656|NCT01149421|3104166|Superiority or Other||||||<|0.001||||||Treatment comparison of mean clinic heart rate (HR) at 26 weeks.|Mixed Models Analysis||||
1687657|NCT01149421|3104166|Superiority or Other||||||<|0.014||||||Treatment comparison of mean clinic heart rate (HR) at 16 weeks.|Mixed Models Analysis||||
1687658|NCT01149421|3104166|Superiority or Other||||||<|0.001||||||Treatment comparison of mean clinic heart rate (HR) at 16 weeks.|Mixed Models Analysis||||
1687659|NCT01149421|3104166|Superiority or Other||Mean Difference (Final Values)|2.24|||<|0.003|2-Sided|95.0|0.78|3.7||Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.|Mixed Models Analysis||||
1687660|NCT01149421|3104166|Superiority or Other||Mean Difference (Final Values)|3.98|||<|0.001|2-Sided|95.0|2.49|5.47||Treatment comparison of mean nighttime heart rate (HR) at 26 weeks.|Mixed Models Analysis||||
1687661|NCT01149421|3104166|Superiority or Other||Mean Difference (Final Values)|2.78|||<|0.001|2-Sided|95.0|1.47|4.09||Treatment comparison of mean nighttime heart rate (HR) at 16 weeks.|Mixed Models Analysis||||
1687662|NCT01149421|3104166|Superiority or Other||Mean Difference (Final Values)|3.95|||<|0.001|2-Sided|95.0|2.62|5.28||Treatment comparison of mean nighttime heart rate (HR) at 16 weeks.|Mixed Models Analysis||||
1687663|NCT01149421|3104166|Superiority or Other||Mean Difference (Final Values)|0.92|||<|0.168|2-Sided|95.0|-0.39|2.24||Treatment comparison of mean daytime heart rate (HR) at 26 weeks.|Mixed Models Analysis||||
1687664|NCT01149421|3104166|Superiority or Other||Mean Difference (Final Values)|3.57|||<|0.001|2-Sided|95.0|2.23|4.91||Treatment comparison of mean daytime heart rate (HR) at 26 weeks.|Mixed Models Analysis||||
1687665|NCT01149421|3104166|Superiority or Other||Mean Difference (Final Values)|1.15|||<|0.08|2-Sided|95.0|-0.14|2.45||Treatment comparison of mean daytime heart rate (HR) at 16 weeks.|Mixed Models Analysis||||
1687666|NCT01149421|3104166|Superiority or Other||Mean Difference (Final Values)|2.49|||<|0.001|2-Sided|95.0|1.17|3.8||Treatment comparison of mean daytime heart rate (HR) at 16 weeks.|Mixed Models Analysis||||
1687667|NCT01149421|3104167|Superiority or Other|||||||0.904||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis||||
1687668|NCT01149421|3104167|Superiority or Other|||||||0.972||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis||||
1687669|NCT01149421|3104167|Superiority or Other|||||||0.173||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis||||
1687670|NCT01149421|3104167|Superiority or Other|||||||0.99||||||Treatment comparison of mean clinic diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis||||
1687671|NCT01149421|3104167|Superiority or Other||Mean Difference (Final Values)|0.27||||0.692|2-Sided|95.0|-1.06|1.6||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis||||
1687672|NCT01149421|3104167|Superiority or Other||Mean Difference (Final Values)|0.47||||0.493|2-Sided|95.0|-0.88|1.82||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis||||
1687673|NCT01149421|3104167|Superiority or Other||Mean Difference (Final Values)|0.82||||0.203|2-Sided|95.0|-0.44|2.08||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis||||
1687674|NCT01149421|3104167|Superiority or Other||Mean Difference (Final Values)|1.08||||0.098|2-Sided|95.0|-0.2|2.37||Treatment comparison of mean nighttime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis||||
1687675|NCT01149421|3104167|Superiority or Other||Mean Difference (Final Values)|0.15||||0.788|2-Sided|95.0|-0.96|1.26||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis||||
1687676|NCT01149421|3104167|Superiority or Other||Mean Difference (Final Values)|0.6||||0.3|2-Sided|95.0|-0.53|1.73||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 26 weeks.|Mixed Models Analysis||||
1687677|NCT01149421|3104167|Superiority or Other||Mean Difference (Final Values)|0.44||||0.427|2-Sided|95.0|-0.65|1.54||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis||||
1687678|NCT01149421|3104167|Superiority or Other||Mean Difference (Final Values)|0.21||||0.717|2-Sided|95.0|-0.91|1.32||Treatment comparison of mean daytime diastolic blood pressure (DBP) at 16 weeks.|Mixed Models Analysis||||
1687679|NCT01149421|3104168|Superiority or Other|||||||0.274||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis||||
1687680|NCT01149421|3104168|Superiority or Other|||||||0.012||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis||||
1687681|NCT01149421|3104168|Superiority or Other|||||||0.601||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis||||
1687682|NCT01149421|3104168|Superiority or Other|||||||0.122||||||Treatment comparison of mean clinic systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis||||
1687683|NCT01149421|3104168|Superiority or Other||Mean Difference (Final Values)|-1.38||||0.159|2-Sided|95.0|-3.31|0.54||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis||||
1687684|NCT01149421|3104168|Superiority or Other||Mean Difference (Final Values)|-2.35||||0.19|2-Sided|95.0|-4.31|-0.39||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis||||
1687685|NCT01149421|3104168|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.884|2-Sided|95.0|-2.1|1.81||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis||||
1687686|NCT01149421|3104168|Superiority or Other||Mean Difference (Final Values)|-1.24||||0.221|2-Sided|95.0|-3.23|0.75||Treatment comparison of mean nighttime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis||||
1687687|NCT01149421|3104168|Superiority or Other||Mean Difference (Final Values)|-1.82||||0.042|2-Sided|95.0|-3.57|-0.07||Treatment comparison of mean daytime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis||||
1687688|NCT01149421|3104168|Superiority or Other||Mean Difference (Final Values)|-2.87||||0.002|2-Sided|95.0|-4.66|-1.09||Treatment comparison of mean daytime systolic blood pressure (SBP) at 26 weeks.|Mixed Models Analysis||||
1687689|NCT01149421|3104168|Superiority or Other||Mean Difference (Final Values)|-1.23||||0.153|2-Sided|95.0|-2.91|0.46||Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis||||
1687690|NCT01149421|3104168|Superiority or Other||Mean Difference (Final Values)|-3.33|||<|0.001|2-Sided|95.0|-5.04|-1.61||Treatment comparison of mean daytime systolic blood pressure (SBP) at 16 weeks.|Mixed Models Analysis||||
1687691|NCT01149421|3104169|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.465|2-Sided|95.0|-1.54|0.7||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1687692|NCT01149421|3104169|Superiority or Other||Mean Difference (Final Values)|-0.58||||0.315|2-Sided|95.0|-1.72|0.55||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1687693|NCT01149421|3104169|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.931|2-Sided|95.0|-1.16|1.06||Treatment comparison at 16 weeks.|Mixed Models Analysis||||
1687694|NCT01149421|3104169|Superiority or Other||Mean Difference (Final Values)|-0.71||||0.218|2-Sided|95.0|-1.84|0.42||Treatment comparison at 16 weeks.|Mixed Models Analysis||||
1687695|NCT01149421|3104170|Superiority or Other||Mean Difference (Final Values)|-1.99|||<|0.001|2-Sided|95.0|-2.98|-1.0||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1687696|NCT01149421|3104170|Superiority or Other||Mean Difference (Final Values)|-3.1|||<|0.001|2-Sided|95.0|-4.1|-2.09||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1687697|NCT01149421|3104170|Superiority or Other||Mean Difference (Final Values)|-1.58|||<|0.001|2-Sided|95.0|-2.51|-0.64||Treatment comparison at 16 weeks.|Mixed Models Analysis||||
1687698|NCT01149421|3104170|Superiority or Other||Mean Difference (Final Values)|-3.05|||<|0.001|2-Sided|95.0|-4.0|-2.09||Treatment comparison at 16 weeks.|Mixed Models Analysis||||
1687699|NCT01149421|3104171|Superiority or Other|||||||0.996||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687700|NCT01149421|3104171|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|1.26||||0.005|2-Sided|97.3|-0.13|2.64||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687701|NCT01149421|3104171|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|3.5||||0.904|2-Sided|97.3|2.1|4.91||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687702|NCT01149421|3104171|Superiority or Other|||||||1||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687703|NCT01149421|3104171|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|1.62||||0.018|2-Sided|97.3|0.32|2.92||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687704|NCT01149421|3104171|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|2.84||||0.556|2-Sided|97.3|1.52|4.16||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687705|NCT01149421|3104172|Superiority or Other|||||||0.776||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687706|NCT01149421|3104172|Superiority or Other|||||||0.929||||||Treatment comparison at 26 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687707|NCT01149421|3104172|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.16|||<|0.001|2-Sided|97.3|-1.0|1.31||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687708|NCT01149421|3104172|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.5|||<|0.001|2-Sided|97.3|-0.68|1.68||Treatment comparison at 26 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687709|NCT01149421|3104172|Superiority or Other||||||<|0.915||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687710|NCT01149421|3104172|Superiority or Other||||||<|0.87||||||Treatment comparison at 16 weeks. Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687711|NCT01149421|3104172|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.42|||<|0.001|2-Sided|97.3|-0.67|1.52||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687712|NCT01149421|3104172|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|0.32|||<|0.001|2-Sided|97.3|-0.8|1.43||Treatment comparison at 16 weeks. P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687713|NCT01149421|3104173|Superiority or Other|||||||0.36||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687714|NCT01149421|3104173|Superiority or Other|||||||0.002||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687715|NCT01149421|3104173|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-1.71|||<|0.001|2-Sided|97.3|-3.54|0.12||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687716|NCT01149421|3104173|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-2.66|||<|0.001|2-Sided|97.3|-4.53|-0.79||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687717|NCT01149421|3104174|Superiority or Other|||||||0.149||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687718|NCT01149421|3104174|Superiority or Other||||||<|0.001||||||Since non-inferiority was confirmed, superiority analysis was pursued. P-value reported for superior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687719|NCT01149421|3104174|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-1.07|||<|0.001|2-Sided|97.3|-2.83|0.68||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687720|NCT01149421|3104174|Non-Inferiority or Equivalence|If non-inferiority was confirmed, then superiority analysis was pursued.|Least Squares Mean Difference|-2.79|||<|0.001|2-Sided|97.3|-4.58|-1.0||P-value reported for non-inferior to Placebo. The adjustment for multiplicity was based on a tree-gatekeeping testing strategy.|Mixed Models Analysis||||
1687721|NCT01149369|3104175|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.84||||0.34|2-Sided|95.0|-2.6|1.0|||ANCOVA||||
1687722|NCT01149369|3104176|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.4||||0.57|2-Sided|95.0|-3.4|6.1|||ANCOVA||||
1687723|NCT01149369|3104177|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-4.8||||0.01|2-Sided|95.0|-8.5|-1.2|||ANCOVA||||
1687724|NCT01149369|3104178|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.5||||0.43|2-Sided|95.0|-2.2|5.1|||ANCOVA||||
1687725|NCT01149369|3104179|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.0||||0.48|2-Sided|95.0|-3.6|7.6|||ANCOVA||||
1687726|NCT01149369|3104180|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|1.2||||0.68|2-Sided|95.0|-4.5|6.9|||ANCOVA||||
1687727|NCT01149369|3104181|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.4||||0.47|2-Sided|95.0|-4.1|8.9|||ANCOVA||||
1687728|NCT01149369|3104182|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-4.2||||0.28|2-Sided|95.0|-12.0|3.5|||ANCOVA||||
1687729|NCT01149369|3104183|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-21.2||||0.4|2-Sided|95.0|-70.5|28.1|||ANCOVA||||
1687730|NCT01149369|3104184|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.6||||0.3|2-Sided|95.0|-4.6|1.4|||ANCOVA||||
1687731|NCT01149369|3104185|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.8||||0.28|2-Sided|95.0|-5.2|1.5|||ANCOVA||||
1687732|NCT01149369|3104186|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-2.2||||0.09|2-Sided|95.0|-4.7|0.4|||ANCOVA||||
1687733|NCT01149369|3104187|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.38|2-Sided|95.0|-1.3|0.5|||ANCOVA||||
1687734|NCT01149369|3104188|Superiority|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.53|2-Sided|95.0|-1.1|0.6|||ANCOVA||||
1687735|NCT01149369|3104189|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.08|2-Sided|95.0|-0.9|0.1|||ANCOVA||||
1687736|NCT01149369|3104190|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.05|2-Sided|95.0|-1.0|0.0|||ANCOVA||||
1687737|NCT01149369|3104191|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.28|2-Sided|95.0|-0.6|0.2|||ANCOVA||||
1687738|NCT01149369|3104192|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.001|2-Sided|95.0|-1.0|-0.2|||ANCOVA||||
1687739|NCT01149369|3104193|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.06|2-Sided|95.0|-0.9|0.0|||ANCOVA||||
1687740|NCT01149369|3104194|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.007|2-Sided|95.0|-0.7|0.1|||ANCOVA||||
1687741|NCT01149369|3104195|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.01||||0.98|2-Sided|95.0|-0.5|0.4|||ANCOVA||||
1687742|NCT01149369|3104196|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.13|2-Sided|95.0|-0.9|0.1|||ANCOVA||||
1687743|NCT01149369|3104197|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.1|2-Sided|95.0|-0.8|0.1|||ANCOVA||||
1687744|NCT01149369|3104198|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.004|2-Sided|95.0|-1.2|-0.2|||ANCOVA||||
1687745|NCT01149369|3104199|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.009|2-Sided|95.0|-1.1|-0.2|||ANCOVA||||
1687746|NCT01149369|3104200|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.17|2-Sided|95.0|-7.0|0.1|||ANCOVA||||
1687747|NCT01149369|3104201|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.09|2-Sided|95.0|-0.8|0.1|||ANCOVA||||
1687748|NCT01149369|3104202|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.06|2-Sided|95.0|-0.9|0.0|||ANCOVA||||
1687749|NCT01149369|3104203|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.02|2-Sided|95.0|-1.0|-0.1|||ANCOVA||||
1687750|NCT01149369|3104204|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.04|2-Sided|95.0|-0.9|0.0|||ANCOVA||||
1687751|NCT01149369|3104205|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.19|2-Sided|95.0|-0.8|0.2|||ANCOVA||||
1687752|NCT01149369|3104206|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.07|2-Sided|95.0|-1.0|0.0|||ANCOVA||||
1687753|NCT01149369|3104207|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.14|2-Sided|95.0|-0.9|0.1|||ANCOVA||||
1687754|NCT01149369|3104208|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.04|2-Sided|95.0|-0.9|0.0|||ANCOVA||||
1687755|NCT01149369|3104209|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8||||0.001|2-Sided|95.0|-1.2|-0.3|||ANCOVA||||
1687756|NCT01149369|3104210|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.72|2-Sided|95.0|-0.4|0.6|||ANCOVA||||
1687757|NCT01149369|3104211|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.05|2-Sided|95.0|-0.9|0.0|||ANCOVA||||
1687758|NCT01149369|3104212|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.16|2-Sided|95.0|-0.8|0.1|||ANCOVA||||
1687759|NCT01149369|3104213|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.03|2-Sided|95.0|-1.0|-0.1|||ANCOVA||||
1687760|NCT01149369|3104214|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8||||0.003|2-Sided|95.0|-2.3|-0.3|||ANCOVA||||
1687761|NCT01149369|3104215|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.001|2-Sided|95.0|-1.1|-0.3|||ANCOVA||||
1687762|NCT01149369|3104216|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.005|2-Sided|95.0|-1.3|-0.2|||ANCOVA||||
1687763|NCT01149369|3104217|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.007|2-Sided|95.0|-0.8|-0.1|||ANCOVA||||
1687764|NCT01149369|3104218|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.08|2-Sided|95.0|-0.9|0.1|||ANCOVA||||
1687765|NCT01149369|3104219|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.004|2-Sided|95.0|-1.2|-0.2|||ANCOVA||||
1687766|NCT01149369|3104220|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.13|2-Sided|95.0|-0.7|0.1|||ANCOVA||||
1687767|NCT01149369|3104221|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.8|||<|0.001|2-Sided|95.0|-1.2|-0.4|||ANCOVA||||
1687768|NCT01149369|3104222|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.6||||0.001|2-Sided|95.0|-0.9|-0.3|||ANCOVA||||
1687769|NCT01149369|3104223|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.008|2-Sided|95.0|-0.2|0.0|||ANCOVA||||
1687770|NCT01149369|3104224|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.18|2-Sided|95.0|0.0|0.1|||ANCOVA||||
1687771|NCT01149369|3104225|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.5||||0.45|2-Sided|95.0|-2.0|0.9|||ANCOVA||||
1687772|NCT01149369|3104226|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.76|2-Sided|95.0|-0.1|0.1|||ANCOVA||||
1687773|NCT01149369|3104227|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.52|2-Sided|95.0|-1.0|0.2|||ANCOVA||||
1687774|NCT01149369|3104228|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.93|2-Sided|95.0|-0.9|1.0|||ANCOVA||||
1687775|NCT01149369|3104229|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.3||||0.53|2-Sided|95.0|-0.7|1.3|||ANCOVA||||
1687776|NCT01149369|3104230|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.7||||0.07|2-Sided|95.0|-1.5|0.0|||ANCOVA||||
1687777|NCT01149369|3104231|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-10.9||||0.17|2-Sided|95.0|-26.5|4.7|||ANCOVA||||
1687778|NCT01149369|3104232|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.88|2-Sided|95.0|-0.1|0.1|||ANCOVA||||
1687779|NCT01149369|3104233|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.8|2-Sided|95.0|-0.6|0.5|||ANCOVA||||
1687780|NCT01149369|3104234|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.77|2-Sided|95.0|-0.7|0.9|||ANCOVA||||
1687781|NCT01149369|3104235|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.44|2-Sided|95.0|-0.2|0.4|||ANCOVA||||
1687782|NCT01149369|3104236|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.46|2-Sided|95.0|-0.2|0.1|||ANCOVA||||
1687783|NCT01149369|3104237|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|3.1||||0.77|2-Sided|95.0|-18.0|24.2|||ANCOVA||||
1687784|NCT01149369|3104238|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.0||||0.97|2-Sided|95.0|-0.5|0.5|||ANCOVA||||
1687785|NCT01149369|3104239|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.23|2-Sided|95.0|-0.1|0.2|||ANCOVA||||
1687786|NCT01149369|3104240|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.1||||0.61|2-Sided|95.0|-5.9|10.0|||ANCOVA||||
1687787|NCT01149369|3104241|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|2.6||||0.59|2-Sided|95.0|-7.0|12.2|||ANCOVA||||
1687788|NCT01149369|3104242|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.3||||0.17|2-Sided|95.0|-0.1|0.7|||ANCOVA||||
1687789|NCT01149369|3104243|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.02|2-Sided|95.0|-0.6|-0.1|||ANCOVA||||
1687790|NCT01149369|3104244|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.12|2-Sided|95.0|-0.5|0.1|||ANCOVA||||
1687791|NCT01149369|3104245|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.03||||0.51|2-Sided|95.0|-0.1|0.1|||ANCOVA||||
1687792|NCT01149369|3104246|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.22|2-Sided|95.0|-0.4|0.1|||ANCOVA||||
1687793|NCT01149369|3104247|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.4||||0.01|2-Sided|95.0|-0.7|-0.1|||ANCOVA||||
1687794|NCT01149369|3104248|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.1||||0.24|2-Sided|95.0|-0.3|0.1|||ANCOVA||||
1687795|NCT01149369|3104249|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.3||||0.06|2-Sided|95.0|-0.6|0.0|||ANCOVA||||
1687796|NCT01149369|3104250|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.2||||0.22|2-Sided|95.0|-0.4|0.1|||ANCOVA||||
1687797|NCT01149369|3104251|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|0.1||||0.73|2-Sided|95.0|-0.4|0.6|||ANCOVA||||
1687798|NCT01149369|3104252|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-0.01||||0.94|2-Sided|95.0|-0.3|0.3|||ANCOVA||||
1687799|NCT01149369|3104253|Non-Inferiority or Equivalence|Mean adjusted change from baseline, 95% confidence limits (CI), and P-values were calculated using ANCOVA, regressing change from baseline to 28 days on treatment group and baseline value of the secondary outcome.|Mean Difference (Net)|-1.5||||0.03|2-Sided|95.0|-2.8|-0.1|||ANCOVA||||
1687800|NCT01149369|3104254|Non-Inferiority or Equivalence|P-values, relative risk ratios, and 95% confidence limits (CI) for the primary ITT were calculated using the Cochran-Mantel-Haenszel chi-square test, stratified by clinic.|Risk Ratio (RR)|1.2||||0.43|2-Sided|95.0|0.8|1.7|||Cochran-Mantel-Haenszel|Stratified by clinic||Either 1) improvement in mean of available nausea VAS scores over 28-day treatment period compared to means of VAS during the 7-day baseline (BL) period being ≤ -25 mm, or 2) mean VAS after 28-days of treatment was < 25 mm.|
1687801|NCT01149148|3104276|Superiority or Other||Mean Difference (Net)|-0.3333|Standard Deviation|1.626||0.678|2-Sided|95.0|-1.36|2.02||A prior threshold for statistical significance is p < 0.05|t-test, 2 sided||The difference between baseline and three months is (baseline – 3 month). The difference in control and intervention is (intervention – control), which in this case is (unblinded – blinded).|The goal was to determine whether cerebral oximetry monitoring during surgery affected cognitive outcomes. Cerebral Oximetry Monitoring unblinded (intervention), and Cerebral Oxymetry Monitoring blinded (control) were given Mini Mental State Exam prior to surgery and three months after surgery. The differences between baseline and 3 month were calculated and compared between the intervention and control groups using t-test.|
1687802|NCT01149057|3104294|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 96|
1687803|NCT01149057|3104294|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 72|
1687804|NCT01149057|3104294|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 48|
1687805|NCT01149057|3104294|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 24|
1687806|NCT01149057|3104295|Superiority or Other||||||<|0.0001|||||||Paired sample T-test||||
1687807|NCT01149057|3104296|Superiority or Other||||||<|0.0001|||||||Paired sample T-test||||
1687808|NCT01149057|3104297|Superiority or Other||||||<|0.0001|||||||Paired sample T-test||||
1687809|NCT01149057|3104298|Superiority or Other||||||<|0.0001|||||||Paired sample T-test|||Analysis was performed using paired sample t-test for change from baseline.|
1687810|NCT01149057|3104299|Superiority or Other||||||<|0.0001|||||||Paired sample T-test||||
1687811|NCT01149057|3104300|Superiority or Other||||||<|0.0001|||||||Paired sample T-test||||
1687812|NCT01149057|3104301|Superiority or Other||||||<|0.0001|||||||Paired sample T-test||||
1687813|NCT01149057|3104302|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 96|
1687814|NCT01149057|3104302|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 72|
1687815|NCT01149057|3104302|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 48|
1687816|NCT01149057|3104302|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test|||Change from baseline at Week 24|
1687817|NCT01149057|3104308|Superiority or Other|||||||0.7094||||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Femoral neck - left T-scores.|
1687818|NCT01149057|3104308|Superiority or Other|||||||0.789||||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Total hip – left T-score|
1687819|NCT01149057|3104308|Superiority or Other|||||||0.1541||||||P value by ANCOVA for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of Total spine T-score|
1687820|NCT01149057|3104308|Superiority or Other|||||||0.3778||||||P value by analysis of covariance (ANCOVA) for the change from baseline, adjusted to number of days between the first and the second DXA test.|ANCOVA|||Comparison of L1-L4 T-scores|
1687821|NCT01149057|3104309|Superiority or Other||||||<|0.0001|||||||Paired sample T-test|||Analysis was performed using paired sample t-test for change from baseline.|
1687822|NCT01148979|3104310|Other|A Paired sample t-test was used to test the null hypothesis of no difference in MDAR score change after 4 weeks of treatment with Vyvanse versus placebo.|||||<|0.05|||||||t-test, 2 sided|||The statistical analysis represents a within-subject comparison of change under treatment with Vyvanse versus change under treatment with placebo, using paired t-tests with each subject as their own control. All tests reported are two-tailed.|
1687823|NCT01148862|3104312|Superiority or Other||Mean Difference (Final Values)|2.0||||0.015||95.0|||||ANCOVA||||
1687824|NCT01148862|3104313|Superiority or Other||Mean Difference (Final Values)|32.2||||0.006|||||||ANCOVA||||
1687825|NCT01148810|3104334|Superiority or Other||Bayesian analysis|0.96|||||||||||||||Probability that the difference (BAF312-Placebo) is greater than the threshold
1687826|NCT01148693|3104342|Superiority or Other||||||<|0.05|||||||Fisher Exact|||Null hypothesis: Adding gentamicin to contrast medium during ERCP has no relation with postERCP cholangitis Power calculation: 80%|
1687827|NCT01148563|3104343|Superiority||Risk Ratio, log|0.7|Standard Error of the Mean|0.22||0.105|2-Sided|95.0|0.45|1.08|||bootstrapping|The standard error was generated by bootstrapping the sample.|The hypothesis test was based on ln(relative risk) with the tele-monitoring group value as the numerator and the control group as the denominator.||
1687828|NCT01148563|3104344|Superiority||Risk Ratio, log|-0.3|Standard Error of the Mean|0.18||0.094|2-Sided|95.0|-0.65|0.05|||bootstrapping||The hypothesis test was based on ln(relative risk), with the tele-monitoring group value as the relative risk numerator and the control group value as the denominator. The standard error was generated by bootstrapping the sample.||
1687829|NCT01148537|3104345|Superiority or Other||Mean Difference (Final Values)|4.68||||0.006|2-Sided|90.0|1.9|7.4|||ANCOVA|||Day 13 analysis|
1687830|NCT01148537|3104345|Superiority or Other||Mean Difference (Final Values)|6.86|||<|0.001|2-Sided|90.0|4.2|9.6|||ANCOVA|||Day 6 analysis|
1687831|NCT01148537|3104346|Superiority or Other||Mean Difference (Final Values)|6.01||||0.001|2-Sided|90.0|3.2|8.8|||ANCOVA|||Day 13 analysis|
1687832|NCT01148537|3104346|Superiority or Other||Mean Difference (Final Values)|1.29||||0.427|2-Sided|90.0|-1.4|4.0|||ANCOVA|||Day 6 analysis|
1687833|NCT01148537|3104347|Superiority or Other||Mean Difference (Final Values)|7.4|||<|0.001|2-Sided|90.0|4.3|10.5|||ANCOVA|||Day 13 analysis|
1687834|NCT01148537|3104347|Superiority or Other||Mean Difference (Final Values)|8.23|||<|0.001|2-Sided|90.0|5.5|10.9|||ANCOVA|||Day 6 analysis|
1687835|NCT01148537|3104348|Superiority or Other||Mean Difference (Final Values)|7.16|||<|0.001|2-Sided|90.0|4.2|10.1|||ANCOVA|||Day 13 analysis|
1687836|NCT01148537|3104348|Superiority or Other||Mean Difference (Final Values)|-0.13|||<|0.936|2-Sided|90.0|-2.9|2.6|||ANCOVA|||Day 6 analysis|
1687837|NCT01148537|3104349|Superiority or Other||Mean Difference (Final Values)|7.64|||<|0.001|2-Sided|90.0|5.4|9.9|||ANCOVA|ANCOVA model with average baseline as a covariate, and with gender and treatment as main effects|||
1687838|NCT01148537|3104350|Superiority or Other||Mean Difference (Final Values)|5.86|||<|0.001|2-Sided|90.0|3.3|8.4|||ANCOVA|ANCOVA model with baseline QTci as a covariate and with sex and treatment as effects in the model.||Day 13 analysis|
1687839|NCT01148537|3104351|Superiority or Other||Mean Difference (Final Values)|0.39||||0.77|2-Sided|90.0|-1.8|2.6|||ANCOVA||For the comparison of BTDS to placebo, the subjects randomized to moxifloxacin were excluded.||
1687840|NCT01148537|3104352|Superiority or Other||Mean Difference (Final Values)|5.91|||<|0.001|2-Sided|90.0|3.4|8.4|||ANCOVA|ANCOVA model with baseline QTci as a covariate and with sex and treatment as effects in the model.|||
1687841|NCT01147926|3104450|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1687842|NCT01147848|3104484|Superiority or Other||Least Squares Mean Difference|-0.037||||0.162|2-Sided|95.0|-0.088|0.015|||ANCOVA||Analysis was performed using ANCOVA with covariates of Baseline FEV1, region, sex, age, and treatment.||
1687843|NCT01147822|3104489|Superiority or Other (legacy)||Hazard Ratio (HR)|1.0184|||||2-Sided|95.0|0.7658|1.3542|||||The HR was estimated by the Cox regression model using treatment stratification factors as covariates. The HR was adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase.||
1687844|NCT01147809|3104497|Superiority or Other||Percent difference|-4.4||||0.802|2-Sided|95.0|-33.5|37.4|||ANCOVA||||
1687845|NCT01147809|3104498|Superiority or Other||Percent difference|12.9||||0.407|2-Sided|95.0|-15.6|51.1|||ANCOVA||||
1687846|NCT01147809|3104520|Superiority or Other||Percent difference|21.1||||0.103|2-Sided|95.0|-3.9|52.5|||ANCOVA||||
1687847|NCT01147744|3104527|Superiority or Other|||||||0.46|||||||Fisher Exact||||
1687848|NCT01147744|3104527|Superiority or Other|||||||0.477|||||||Fisher Exact||||
1687849|NCT01147744|3104527|Superiority or Other|||||||0.828|||||||Fisher Exact||||
1687850|NCT01147744|3104527|Superiority or Other|||||||1|||||||Fisher Exact||||
1687851|NCT01147744|3104527|Superiority or Other|||||||0.814|||||||Fisher Exact||||
1687852|NCT01147744|3104527|Superiority or Other|||||||1|||||||Fisher Exact||||
1687853|NCT01147744|3104528|Superiority or Other||Mean Difference (Net)|-0.158||||0.095|2-Sided|95.0|-0.34|0.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687854|NCT01147744|3104528|Superiority or Other||Mean Difference (Net)|-0.171||||0.07|2-Sided|95.0|-0.36|0.01|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687855|NCT01147744|3104528|Superiority or Other||Mean Difference (Net)|-0.002||||0.98|2-Sided|95.0|-0.19|0.18|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687856|NCT01147744|3104528|Superiority or Other||Mean Difference (Net)|-0.123||||0.19|2-Sided|95.0|-0.31|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687857|NCT01147744|3104528|Superiority or Other||Mean Difference (Net)|-0.138||||0.145|2-Sided|95.0|-0.32|0.05|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687858|NCT01147744|3104528|Superiority or Other||Mean Difference (Net)|-0.098||||0.3|2-Sided|95.0|-0.28|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687859|NCT01147744|3104529|Superiority or Other||Mean Difference (Net)|-0.207||||0.047|2-Sided|95.0|-0.41|0.0|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687860|NCT01147744|3104529|Superiority or Other||Mean Difference (Net)|-0.245||||0.018|2-Sided|95.0|-0.45|-0.04|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687861|NCT01147744|3104529|Superiority or Other||Mean Difference (Net)|-0.045||||0.662|2-Sided|95.0|-0.25|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687862|NCT01147744|3104529|Superiority or Other||Mean Difference (Net)|-0.076||||0.464|2-Sided|95.0|-0.28|0.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1688624|NCT01131260|3106487|Superiority or Other||Risk Ratio (RR)|2.86||||0.02|2-Sided|95.0|1.13|7.24|||Chi-squared||||
1687863|NCT01147744|3104529|Superiority or Other||Mean Difference (Net)|-0.264||||0.011|2-Sided|95.0|-0.47|-0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687864|NCT01147744|3104529|Superiority or Other||Mean Difference (Net)|-0.131||||0.209|2-Sided|95.0|-0.33|0.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687865|NCT01147744|3104530|Superiority or Other||Mean Difference (Net)|-0.083||||0.248|2-Sided|95.0|-0.22|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687866|NCT01147744|3104530|Superiority or Other||Mean Difference (Net)|-0.051||||0.471|2-Sided|95.0|-0.19|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687867|NCT01147744|3104530|Superiority or Other||Mean Difference (Net)|0.01||||0.887|2-Sided|95.0|-0.13|0.15|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687868|NCT01147744|3104530|Superiority or Other||Mean Difference (Net)|-0.021||||0.768|2-Sided|95.0|-0.16|0.12|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687869|NCT01147744|3104530|Superiority or Other||Mean Difference (Net)|-0.096||||0.176|2-Sided|95.0|-0.24|0.04|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687870|NCT01147744|3104530|Superiority or Other||Mean Difference (Net)|0.028||||0.692|2-Sided|95.0|-0.11|0.17|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687871|NCT01147744|3104531|Superiority or Other||Mean Difference (Net)|-0.075||||0.36|2-Sided|95.0|-0.24|0.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687872|NCT01147744|3104531|Superiority or Other||Mean Difference (Net)|-0.097||||0.238|2-Sided|95.0|-0.26|0.06|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687873|NCT01147744|3104531|Superiority or Other||Mean Difference (Net)|-0.003||||0.972|2-Sided|95.0|-0.16|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687874|NCT01147744|3104531|Superiority or Other||Mean Difference (Net)|-0.028||||0.734|2-Sided|95.0|-0.19|0.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687875|NCT01147744|3104531|Superiority or Other||Mean Difference (Net)|-0.166||||0.043|2-Sided|95.0|-0.33|-0.01|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687876|NCT01147744|3104531|Superiority or Other||Mean Difference (Net)|-0.005||||0.951|2-Sided|95.0|-0.17|0.16|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687877|NCT01147744|3104532|Superiority or Other||Mean Difference (Net)|3.611||||0.403|2-Sided|95.0|-4.87|12.09|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687878|NCT01147744|3104532|Superiority or Other||Mean Difference (Net)|7.49||||0.081|2-Sided|95.0|-0.92|15.9|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687879|NCT01147744|3104532|Superiority or Other||Mean Difference (Net)|-1.218||||0.776|2-Sided|95.0|-9.6|7.17|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687880|NCT01147744|3104532|Superiority or Other||Mean Difference (Net)|2.702||||0.528|2-Sided|95.0|-5.7|11.11|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687881|NCT01147744|3104532|Superiority or Other||Mean Difference (Net)|0.431||||0.92|2-Sided|95.0|-8.0|8.86|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687882|NCT01147744|3104532|Superiority or Other||Mean Difference (Net)|2.346||||0.585|2-Sided|95.0|-6.09|10.78|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687883|NCT01147744|3104533|Superiority or Other||Mean Difference (Net)|6.75||||0.125|2-Sided|95.0|-1.89|15.38|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687884|NCT01147744|3104533|Superiority or Other||Mean Difference (Net)|9.592||||0.028|2-Sided|95.0|1.03|18.15|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687885|NCT01147744|3104533|Superiority or Other||Mean Difference (Net)|1.713||||0.694|2-Sided|95.0|-6.84|10.26|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687886|NCT01147744|3104533|Superiority or Other||Mean Difference (Net)|2.148||||0.623|2-Sided|95.0|-6.42|10.72|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687887|NCT01147744|3104533|Superiority or Other||Mean Difference (Net)|4.106||||0.349||95.0|-4.49|12.7|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687888|NCT01147744|3104533|Superiority or Other||Mean Difference (Net)|6.106||||0.164|2-Sided|95.0|-2.5|14.71|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687889|NCT01147744|3104534|Superiority or Other||Mean Difference (Net)|5.394||||0.191|2-Sided|95.0|-2.69|13.48|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687890|NCT01147744|3104534|Superiority or Other||Mean Difference (Net)|5.949||||0.146|2-Sided|95.0|-2.08|13.98|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687891|NCT01147744|3104534|Superiority or Other||Cox Proportional Hazard|-1.781||||0.662|2-Sided|95.0|-9.78|6.22|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687892|NCT01147744|3104534|Superiority or Other||Mean Difference (Net)|2.124||||0.603|2-Sided|95.0|-5.9|10.14|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1688625|NCT01131260|3106488|Superiority or Other||Risk Ratio (RR)|3.02||||0.37|2-Sided|95.0|0.31|29.1|||Fisher Exact||||
1687893|NCT01147744|3104534|Superiority or Other||Mean Difference (Net)|2.715||||0.508|2-Sided|95.0|-5.33|10.76|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687894|NCT01147744|3104534|Superiority or Other||Mean Difference (Net)|0.837||||0.838|2-Sided|95.0|-7.22|8.89|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687895|NCT01147744|3104535|Superiority or Other||Mean Difference (Net)|2.891||||0.475|2-Sided|95.0|-5.05|10.83|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687896|NCT01147744|3104535|Superiority or Other||Mean Difference (Net)|8.204||||0.041|2-Sided|95.0|0.34|16.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687897|NCT01147744|3104535|Superiority or Other||Mean Difference (Net)|0.083||||0.983|2-Sided|95.0|-7.76|7.93|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687898|NCT01147744|3104535|Superiority or Other||Mean Difference (Net)|1.326||||0.741|2-Sided|95.0|-6.54|9.19|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687899|NCT01147744|3104535|Superiority or Other||Mean Difference (Net)|4.56||||0.257|2-Sided|95.0|-3.33|12.45|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687900|NCT01147744|3104535|Superiority or Other||Mean Difference (Net)|1.169||||0.771|2-Sided|95.0|-6.73|9.07|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline, age, gender, country and smoking status.|||
1687901|NCT01147744|3104536|Superiority or Other||Mean Difference (Net)|5.615||||0.229|2-Sided|95.0|-3.55|14.78|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.|||
1687902|NCT01147744|3104536|Superiority or Other||Mean Difference (Net)|3.484||||0.452|2-Sided|95.0|-5.61|12.58|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.|||
1687903|NCT01147744|3104536|Superiority or Other||Mean Difference (Net)|4.585||||0.32|2-Sided|95.0|-4.47|13.64|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.|||
1687904|NCT01147744|3104536|Superiority or Other||Mean Difference (Net)|-3.046||||0.51|2-Sided|95.0|-12.12|6.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.|||
1687905|NCT01147744|3104536|Superiority or Other||Mean Difference (Net)|3.75||||0.419|2-Sided|95.0|-5.36|12.87|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.|||
1687906|NCT01147744|3104536|Superiority or Other||Mean Difference (Net)|1.463||||0.753|2-Sided|95.0|-7.65|10.58|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.|||
1687907|NCT01147744|3104537|Superiority or Other||Mean Difference (Net)|0.529||||0.907|2-Sided|95.0|-8.4|9.45|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.|||
1687908|NCT01147744|3104537|Superiority or Other||Mean Difference (Net)|2.46||||0.584|2-Sided|95.0|-6.36|11.28|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.|||
1687909|NCT01147744|3104537|Superiority or Other||Mean Difference (Net)|2.321||||0.605|2-Sided|95.0|-6.49|11.13|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.|||
1687910|NCT01147744|3104537|Superiority or Other||Median Difference (Net)|-1.798||||0.689|2-Sided|95.0|-10.62|7.03|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.|||
1687911|NCT01147744|3104537|Superiority or Other||Mean Difference (Net)|1.367||||0.762|2-Sided|95.0|-7.5|10.23|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.|||
1687912|NCT01147744|3104537|Superiority or Other||Mean Difference (Net)|-0.385||||0.932|2-Sided|95.0|-9.25|8.48|||ANCOVA|Analysis was performed using ANCOVA with covariates of Baseline trough PM PEF, age, gender, country and smoking status.|||
1687913|NCT01147744|3104538|Superiority or Other||Mean Difference (Net)|0.07||||0.22|2-Sided|95.0|-0.04|0.18||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.|||
1687914|NCT01147744|3104538|Superiority or Other||Mean Difference (Net)|0.189|||<|0.001|2-Sided|95.0|0.08|0.3||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.|||
1687915|NCT01147744|3104538|Superiority or Other||Mean Difference (Net)|0.062|||<|0.271|2-Sided|95.0|-0.05|0.17||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.|||
1687916|NCT01147744|3104538|Superiority or Other||Mean Difference (Net)|0.069|||<|0.224|2-Sided|95.0|-0.04|0.18||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.|||
1687951|NCT01147653|3104566|Superiority|||||||0.294|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Growth and Development change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1688688|NCT01130272|3106631|Superiority or Other (legacy)||Odds Ratio (OR)|2.797||||0.015|2-Sided|95.0|1.227|6.376|||ANCOVA||||
1687917|NCT01147744|3104538|Superiority or Other||Mean Difference (Net)|0.104|||<|0.066|2-Sided|95.0|-0.01|0.22||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.|||
1687918|NCT01147744|3104538|Superiority or Other||Mean Difference (Net)|0.056|||<|0.326|2-Sided|95.0|-0.06|0.17||The study type I error rate was controlled at 5% level for primary efficacy analyses using the Week 8 trough FEV1 endpoint, by performing statistical tests of GSK2190915 versus placebo, sequentially from highest dose (300 mg) to lowest dose (10 mg).|ANCOVA|ANCOVA model used with covariates of Baseline trough FEV1, age, gender, country and smoking status. The LOCF method used to impute missing data.|||
1687919|NCT01147653|3104539|Superiority||Mean Difference (Final Values)|0.2||||0.04|2-Sided|95.0|0.01|0.38|||Wilcoxon (Mann-Whitney)|||H0: The true mean 1-year change in normalized whole brain connectivity is the same in patients infused with Low and High doses of autologous umbilical cord blood.|
1687920|NCT01147653|3104540|Superiority|H0: The population distribution of the Peabody Gross Motor Quotient change score 1 year post-infusion with autologous umbilical cord blood is the same in patients receiving a Low infused dose and a High infused dose.||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1687921|NCT01147653|3104541|Superiority||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of differences between observed and expected GMFM-66 change scores at 1-year post-infusion is the same for patients receiving Low and High doses of autologous umbilical cord blood.|
1687922|NCT01147653|3104542|Superiority|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with Low doses of autologous umbilical cord blood and placebo.|
1687923|NCT01147653|3104542|Superiority|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with High doses of autologous umbilical cord blood and Placebo.|
1687924|NCT01147653|3104542|Superiority|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of the 1-year GMFM-66 change score is the same for patients infused with Low and High doses of autologous umbilical cord blood.|
1687925|NCT01147653|3104543|Superiority|||||||0.762|||||||Wilcoxon (Mann-Whitney)||||
1687926|NCT01147653|3104546|Superiority|||||||0.233|||||||Wilcoxon (Mann-Whitney)|||H0: The population distribution of Modified Ashworth Scale scores is the same at 1-year post-infusion with autologous cord blood and placebo.|
1687927|NCT01147653|3104548|Superiority|||||||0.31|||||||t-test, 2 sided||||
1687928|NCT01147653|3104549|Superiority|||||||0.029|||||||Wilcoxon (Mann-Whitney)||||
1687929|NCT01147653|3104550|Superiority|||||||0.478|||||||t-test, 2 sided||||
1687930|NCT01147653|3104551|Superiority|||||||0.131|||||||Wilcoxon (Mann-Whitney)||||
1687931|NCT01147653|3104552|Superiority|||||||0.099|||||||t-test, 2 sided||||
1687932|NCT01147653|3104553|Superiority|||||||0.176|||||||Wilcoxon (Mann-Whitney)||||
1687933|NCT01147653|3104554|Superiority|||||||0.76|||||||t-test, 2 sided||||
1687934|NCT01147653|3104555|Superiority|||||||0.76|||||||Wilcoxon (Mann-Whitney)||||
1687935|NCT01147653|3104556|Superiority|||||||0.544|||||||t-test, 2 sided||||
1687936|NCT01147653|3104557|Superiority|||||||0.912|||||||t-test, 2 sided||||
1687937|NCT01147653|3104558|Superiority|||||||0.697|||||||t-test, 2 sided||||
1687938|NCT01147653|3104561|Superiority|||||||0.29|||||||t-test, 2 sided||||
1687939|NCT01147653|3104565|Superiority|||||||0.225|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Social wellbeing and acceptance change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687940|NCT01147653|3104565|Superiority|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Participation and Physical Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687941|NCT01147653|3104565|Superiority|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Pain and Impact of Disability change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687942|NCT01147653|3104565|Superiority|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Functioning change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687943|NCT01147653|3104565|Superiority|||||||0.647|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month 2 Family Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687944|NCT01147653|3104565|Superiority|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month 2 Emotional Well Being and Self Esteem change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687945|NCT01147653|3104565|Superiority|||||||0.055|||||||Wilcoxon (Mann-Whitney)|||H0: The 12 month Access to Services change score is identically distributed in patients assigned Autologous Cord Blood Reinfusion First and Placebo First.|
1687946|NCT01147653|3104566|Superiority|||||||0.869|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Temperament and Moods change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687947|NCT01147653|3104566|Superiority|||||||0.381|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Physical Abilities change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687948|NCT01147653|3104566|Superiority|||||||0.396|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Parental Impact-Time change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687949|NCT01147653|3104566|Superiority|||||||0.315|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Parental Impact-Emotional change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687950|NCT01147653|3104566|Superiority|||||||0.726|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Overall Health change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1688038|NCT01145898|3104744|Superiority or Other|||||||0.2265|||||||ANCOVA||||
1687952|NCT01147653|3104566|Superiority|||||||0.199|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Global Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687953|NCT01147653|3104566|Superiority|||||||0.927|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month General Health Perceptions change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687954|NCT01147653|3104566|Superiority|||||||0.322|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month General Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687955|NCT01147653|3104566|Superiority|||||||0.844|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Family Cohesion change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687956|NCT01147653|3104566|Superiority|||||||0.377|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Bodily Pain/Discomfort change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687957|NCT01147653|3104566|Superiority|||||||0.473|||||||Wilcoxon (Mann-Whitney)|||H0: The 12-month Behavior change score is identically distributed in patients assigned Autologous UCB Reinfusion First and Placebo First.|
1687958|NCT01147653|3104567|Superiority|||||||0.39|||||||Wilcoxon (Mann-Whitney)||||
1687959|NCT01147653|3104568|Superiority||Mean Difference (Final Values)|0.6||||0.72|2-Sided|95.0|-2.6|3.7|||t-test, 2 sided|||H0: The true mean 1-year change in GMFM-66 is the same on Autologous Umbilical Cord Blood and Placebo|
1687960|NCT01147640|3104569|Superiority or Other||Risk Difference (RD)|-5.2|||||2-Sided|95.0|||||||||
1687961|NCT01147640|3104570|Superiority or Other||Risk Difference (RD)|-12.4|||||2-Sided||||||||||
1687962|NCT01147627|3104574|Non-Inferiority or Equivalence|108 patients in each group was needed to provide 90% power to detect non-inferiority of exenatide, shown by a mean difference of 0.4% in HbA1c change from baseline.|||||<|0.05|||||||ANCOVA||||
1687963|NCT01147458|3104592|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|0.162|||2-Sided|80.0|-0.11|0.31||||||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687964|NCT01147458|3104592|Superiority or Other||Mean Difference (Net)|0.09|Standard Error of the Mean|0.168|||2-Sided|80.0|-0.12|0.31||||||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687965|NCT01147458|3104593|Superiority or Other||Mean Difference (Net)|0.12|Standard Error of the Mean|0.147|||2-Sided|80.0|-0.07|0.31||||||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687966|NCT01147458|3104593|Superiority or Other||Mean Difference (Net)|0.01|Standard Error of the Mean|0.15|||2-Sided|80.0|-0.18|0.2||||||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687967|NCT01147458|3104594|Superiority or Other||Mean Difference (Net)|-0.16|Standard Error of the Mean|0.628|||2-Sided|80.0|-0.97|0.65||||||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687968|NCT01147458|3104594|Superiority or Other||Mean Difference (Net)|0.77|Standard Error of the Mean|0.624|||2-Sided|80.0|-0.03|1.58||||||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687969|NCT01147458|3104595|Superiority or Other||Mean Difference (Net)|-0.33|Standard Error of the Mean|1.709|||2-Sided|80.0|-2.53|1.88||||||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687970|NCT01147458|3104595|Superiority or Other||Mean Difference (Net)|2.06|Standard Error of the Mean|1.699|||2-Sided|80.0|-0.13|4.25||||||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687971|NCT01147458|3104596|Superiority or Other||Mean Difference (Net)|-0.34|Standard Error of the Mean|1.252|||2-Sided|80.0|-1.95|1.28||||||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687972|NCT01147458|3104596|Superiority or Other||Mean Difference (Net)|1.26|Standard Error of the Mean|1.239|||2-Sided|80.0|-0.34|2.85||||||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687973|NCT01147458|3104597|Superiority or Other||Mean Difference (Net)|0.13|Standard Error of the Mean|0.17|||2-Sided|80.0|-0.09|0.35||||||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687974|NCT01147458|3104597|Superiority or Other||Mean Difference (Net)|0.07|Standard Error of the Mean|0.172|||2-Sided|80.0|-0.15|0.29||||||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687975|NCT01147458|3104598|Superiority or Other||Mean Difference (Net)|-0.2|Standard Error of the Mean|0.369||0.701|2-Sided|80.0|-0.67|0.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687976|NCT01147458|3104598|Superiority or Other||Mean Difference (Net)|0.56|Standard Error of the Mean|0.374||0.067|2-Sided|80.0|0.08|1.04|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1688039|NCT01145898|3104745|Superiority or Other|||||||0.1564|||||||ANCOVA||||
1687977|NCT01147458|3104599|Superiority or Other||Mean Difference (Net)|-0.2|Standard Error of the Mean|0.369||0.701|2-Sided|80.0|-0.67|0.28|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687978|NCT01147458|3104599|Superiority or Other||Mean Difference (Net)|0.56|Standard Error of the Mean|0.374||0.067|2-Sided|80.0|0.08|1.04|||ANCOVA|||The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.|
1687979|NCT01147302|3104630|Superiority or Other||Mean treatment difference|0.24||||0.947|2-Sided|90.0|-6.05|6.52||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 1 through Day 90|
1687980|NCT01147302|3104630|Superiority or Other||Mean treatment difference|1.56||||0.4558|2-Sided|90.0|-2.0|5.11||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 1 through Day 20|
1687981|NCT01147302|3104631|Superiority or Other||Mean treatment difference|4.68||||0.5895|2-Sided|95.0|-10.19|19.55||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 90|
1687982|NCT01147302|3104631|Superiority or Other||Mean treatment difference|1.45||||0.9046|2-Sided|95.0|-19.34|22.24||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 20|
1687983|NCT01147302|3104632|Superiority or Other||Mean treatment difference|-0.01||||0.9533|2-Sided|95.0|-0.44|0.41||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 90|
1687984|NCT01147302|3104632|Superiority or Other||Mean treatment difference|0.08||||0.7591|2-Sided|95.0|-0.35|0.51||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of Day 20|
1687985|NCT01147302|3104633|Superiority or Other||Mean treatment difference|4.56||||0.5103|2-Sided|95.0|-7.25|16.37||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of chronic vasculitis score|
1687986|NCT01147302|3104633|Superiority or Other||Mean treatment difference|5.67||||0.4723|2-Sided|95.0|-7.77|9.11||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of interstitial fibrosis score|
1687987|NCT01147302|3104633|Superiority or Other||Mean treatment difference|-0.22||||0.3322|2-Sided|95.0|-0.61|0.17||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of chronic glomerulopathy score|
1687988|NCT01147302|3104633|Superiority or Other||Mean treatment difference|-4.89||||0.2042|2-Sided|95.0|-11.34|1.56||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of glomerulosclerosis score|
1687989|NCT01147302|3104633|Superiority or Other||Mean treatment difference|7.11||||0.0508|2-Sided|95.0|1.23|12.99||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of vasculitis score|
1687990|NCT01147302|3104633|Superiority or Other||Mean treatment difference|-4.0||||0.6928|2-Sided|95.0|-21.36|13.36||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of glomerulitis score|
1687991|NCT01147302|3104633|Superiority or Other||Mean treatment difference|18.56||||0.0768|2-Sided|95.0|1.43|35.68||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of margination score|
1687992|NCT01147302|3104633|Superiority or Other||Mean treatment difference|8.89||||0.6498|2-Sided|95.0|-24.65|42.42||The p-value for testing the mean for the treatment difference comparison assessed from ANOVA model analysis for CINRYZE versus placebo.|ANOVA|||Analysis of C4d score|
1687993|NCT01147250|3104638|Superiority or Other||Hazard Ratio (HR)|1.017||||0.8542|2-Sided|95.0|0.886|1.168|||Log Rank||Lixisenatide vs Placebo|Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% CI. Superiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was <1.0.|
1687994|NCT01147250|3104638|Non-Inferiority or Equivalence|Non-inferiority of lixisenatide versus placebo was to be claimed if the upper bound of the 2-sided 95% CI of the hazard ratio was <1.3.|Hazard Ratio (HR)|1.017|||||2-Sided|95.0|0.886|1.168|||||Lixisenatide vs Placebo|Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% confidence interval (CI).|
1687995|NCT01147055|3104653|Superiority or Other||Ratio of Adjusted Means|11.01|||||2-Sided|90.0|9.02|13.45||||||Natural log transformed Cmax of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687996|NCT01147055|3104655|Superiority or Other||Ratio of Adjusted Means|5.75|||||2-Sided|90.0|4.86|6.81||||||Natural log transformed AUC (0 - ∞) of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687997|NCT01147055|3104656|Superiority or Other||Ratio of Adjusted Means|5.49|||||2-Sided|90.0|4.64|6.49||||||Natural log transformed AUClast of PF-06260182 was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687998|NCT01147055|3104661|Superiority or Other||Ratio of Adjusted Means|17.6|||||2-Sided|90.0|15.48|20.02||||||Natural log transformed AUClast of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1687999|NCT01147055|3104662|Superiority or Other||Ratio of Adjusted Means|31.49|||||2-Sided|90.0|26.43|37.51||||||Natural log transformed Cmax of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% CIs for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1688000|NCT01147055|3104663|Superiority or Other||Ratio of Adjusted Means|18.21|||||2-Sided|90.0|16.14|20.54||||||Natural log transformed AUC (0-∞) of crizotinib was analyzed using a mixed effect model with treatment as a fixed effect and participant as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences was exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1688001|NCT01146951|3104665|Superiority or Other|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Analysis of final assessment (LOCF)|
1688002|NCT01146951|3104665|Superiority or Other|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Analysis of Week 12 of the Treatment Period|
1688003|NCT01146951|3104666|Superiority or Other||Hodges-Lehmann method|-52.1||||0.221|2-Sided|90.0|-89.1|10.8|||Wilcoxon (Mann-Whitney)|||Analysis of Atonic seizure frequency|
1688004|NCT01146951|3104666|Superiority or Other||Hodges-Lehmann method|-71.4||||0.107|2-Sided|90.0|-464.7|30.5|||Wilcoxon (Mann-Whitney)|||Analysis for Tonic-clonic seizure frequency|
1688005|NCT01146951|3104666|Superiority or Other||Hodges-Lehmann method|-23.2||||0.031|2-Sided|90.0|-40.7|-5.6|||Wilcoxon (Mann-Whitney)|||Analysis of tonic seizure frequency|
1688006|NCT01146951|3104666|Superiority or Other||Hodges-Lehmann method|-54.35||||0.021|2-Sided|90.0|-126.6|-15.4|||Wilcoxon (Mann-Whitney)|||Analysis for myoclonic seizure frequency|
1688007|NCT01146951|3104666|Superiority or Other||Hodges-Lehmann method|-28.65||||0.128|2-Sided|90.0|-72.0|0.9|||Wilcoxon (Mann-Whitney)|||Analysis of atypical absence seizure frequency|
1688008|NCT01146951|3104666|Superiority or Other||Hodges-Lehmann method|-57.15||||0.025|2-Sided|90.0|-104.5|-17.3|||Wilcoxon (Mann-Whitney)|||Analysis for Partial Seizure Frequency|
1688009|NCT01146951|3104667|Superiority or Other||Hodges-Lehmann method|-33.3|||<|0.001|2-Sided|90.0|-47.1|-17.0|||Wilcoxon (Mann-Whitney)||||
1688010|NCT01146951|3104668|Superiority or Other|||||||0.074|||||||Fisher’s exact test||||
1688011|NCT01146951|3104669|Superiority or Other||Hodges–Lehmann|-26.65||||0.003|2-Sided|90.0|-40.3|-11.8|||Wilcoxon (Mann-Whitney)||||
1688012|NCT01146873|3104675|Superiority or Other|||||||0.003|||||||Chi-squared||||
1688013|NCT01146873|3104677|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1688014|NCT01146873|3104678|Non-Inferiority or Equivalence|The null hypothesis is that efavirenz is inferior to ritonavir-boosted lopinavir.|Risk Difference (RD)|-0.007|||<|0.001|2-Sided||||||Kaplan-Meier methods||||
1688015|NCT01146873|3104679|Non-Inferiority or Equivalence|The null hypothesis is that efavirenz is inferior to ritonavir-boosted lopinavir.|Risk Difference (RD)|0.107|||<|0.001|2-Sided||||||Kaplan-Meier methods||||
1688016|NCT01146834|3104685|Superiority||Risk Difference (RD)|-0.25||||0.25|2-Sided|95.0|-0.68|0.18|||Fisher Exact||||
1688017|NCT01146834|3104687|Superiority||Risk Difference (RD)|-0.02||||0.9|2-Sided|95.0|-0.32|0.28|||Chi-squared|||Arm B was initially closed due to low accrual, and Arms D and E were also closed due to no accrual. Arms A and C also had very low accrual. Therefore, the comparison of the primary outcome between Arms A and C is for exploratory purposes only.|
1688018|NCT01146600|3104711|Superiority or Other|||||||0.76|||||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo|||
1688019|NCT01146600|3104712|Superiority or Other|||||||0.01|||||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo|||
1688020|NCT01146600|3104713|Superiority or Other|||||||0.002|||||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo|||
1688021|NCT01146600|3104714|Superiority or Other|||||||0.002|||||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo|||
1688022|NCT01146600|3104715|Superiority or Other|||||||0.64|||||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo|||
1688023|NCT01146600|3104716|Superiority or Other|||||||0.63|||||||ANOVA|ANOVA comparing baseline, clarithromycin, and placebo|||
1688024|NCT01146600|3104717|Superiority or Other|||||||0.47|||||||ANOVA|ANOVA, comparing baseline, clarithromycin, and placebo|||
1688025|NCT01146418|3104725|Superiority or Other||Estimated difference|-1.2|||||2-Sided|95.0|-5.7|3.4|||||||
1688026|NCT01146418|3104726|Superiority or Other||Estimated Difference|-1.8|||||2-Sided|95.0|-6.5|3.0|||||||
1688027|NCT01146379|3104727|Superiority or Other|||||||0.209|||||||t-test, 2 sided|||This analysis tested if the Low Movement Dose group was different from the Individual Maximum High Movement Dose group|
1688028|NCT01146379|3104727|Superiority or Other|||||||0.679|||||||t-test, 2 sided|||This analysis asked if the Low Movement Dose group was different from the High Movement Dose group|
1688029|NCT01146379|3104727|Superiority or Other|||||||0.036|||||||t-test, 2 sided|||This analysis then asked which groups were different from the Low Movement Dose group|
1688030|NCT01146379|3104727|Superiority or Other|||||||0.01||||||a prior threshold for statistical significance = 0.05. P value was not corrected for multiple comparisons|Mixed Models Analysis|||The primary analysis used hierarchical linear modeling to examine the rate of change in ARAT over time. The null hypothesis was that all groups would change at a similar rate.|
1688031|NCT01145898|3104737|Superiority or Other|||||||0.2528|||||||ANCOVA||||
1688032|NCT01145898|3104738|Superiority or Other|||||||0.7597|||||||ANCOVA||||
1688033|NCT01145898|3104739|Superiority or Other|||||||0.0199|||||||ANCOVA||||
1688034|NCT01145898|3104740|Superiority or Other|||||||0.1319|||||||ANCOVA||||
1688035|NCT01145898|3104741|Superiority or Other|||||||0.8119|||||||ANCOVA||||
1688036|NCT01145898|3104742|Superiority or Other|||||||0.5998|||||||ANCOVA||||
1688037|NCT01145898|3104743|Superiority or Other|||||||0.4645|||||||ANCOVA||||
1688044|NCT01145898|3104750|Superiority or Other|||||||0.6261|||||||ANCOVA|||There will be (as shown) differences in the number of subjects based upon the time of analysis due to patient loss, data of insufficient quality at visit, or change in the drug use during period of study (patient switched off treatment by their doctor) so the number of data points varies throughout the analysis by availability.|
1688045|NCT01145625|3104775|Superiority or Other||Mean Difference (Final Values)|-1.5||||0.598|2-Sided|95.0|-7.1|4.1|||ANCOVA|P-value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 52 data.|
1688046|NCT01145625|3104776|Superiority or Other||Mean Difference (Final Values)|2.4|||<|0.4158|2-Sided|95.0|-3.4|8.2|||ANCOVA|P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 12 data.|
1688047|NCT01145625|3104777|Non-Inferiority or Equivalence|Noninferiority was claimed if the lower limit of the 95% Confidence Interval (CI) was greater than -6.565.|Mean Difference (Final Values)|-0.3||||0.917|2-Sided|95.0|-6.0|5.4|||ANCOVA|P-Value and confidence interval are from ANCOVA model with treatment and center as factors and Baseline hair count as a covariate.||Statistical analysis is for the change from baseline to week 24 data.|
1688048|NCT01145391|3104800|Non-Inferiority or Equivalence|Equivalence||||||0.5||||||For systolic blood pressure|Mixed Models Analysis||||
1688049|NCT01145222|3104808|Superiority|Overall comparison between remimazolam and midazolam||||||0.007|||||||Fisher Exact||||
1688050|NCT01144663|3104899|Non-Inferiority|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|-1.32|||||2-Sided|95.0|-2.84|-0.48||||||To demonstrate the non-inferiority of the Nimenrix 2 Group compared to NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference [Nimenrix 2 Group minus NeisVac-C Group] in the percentages of subjects with bactericidal vaccine response to MenC was computed.|
1688051|NCT01144663|3104899|Non-Inferiority|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|-0.88|||||2-Sided|95.0|-2.45|0.43||||||To demonstrate the non-inferiority of the Nimenrix 2 Group compared to Menjugate Group, two-sided standardized asymptotic 95% CI for the groups difference [Nimenrix 2 Group minus Menjugate Group] in the percentages of subjects with bactericidal vaccine response to MenC was computed.|
1688052|NCT01144663|3104899|Non-Inferiority|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percenttage|-0.43|||||2-Sided|95.0|-1.57|0.4||||||To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the NeisVac-C Group, two-sided standardized asymptotic 95% CI for the groups difference [Nimenrix 3 Group minus NeisVac-C Group] in the percentages of subjects with bactericidal vaccine response to MenC was computed.|
1688053|NCT01144663|3104899|Non-Inferiority|Indication of non-inferiority of Nimenrix 3 Group compared to Menjugate Group is a lower limit of the 95% CI of the group difference greater than or equal to the predefined clinical limits of -5%.|Difference in percentage|0.01|||||2-Sided|95.0|-1.17|1.2||||||To demonstrate the non-inferiority of the Nimenrix 3 Group compared to the Menjugate Group, two-sided standardized asymptotic 95% CI (confidence interval) for the groups difference [Nimenrix 3 Group minus Menjugate Group] in the percentages of subjects with bactericidal vaccine response to MenC was computed.|
1688054|NCT01144637|3104912|Equivalence|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as [0.5; 2] for the GMT ratios (pairwise)|GMT ratio (Group 2 / Group 3)|0.8577|||||2-Sided|95.0|0.7753|0.9488|||||||
1688055|NCT01144637|3104912|Equivalence|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as [0.5; 2] for the GMT ratios (pairwise)|GMT ratio (Group 1 / Group 3)|0.9444|||||2-Sided|95.0|0.8554|1.0427|||||||
1688056|NCT01144637|3104912|Equivalence|The equivalence margins to show that the 3 vaccine lots are equivalent in terms of PRNT GMTs at Week 6 was predefined as [0.5; 2] for the GMT ratios (pairwise)|GMT ratio (Group 1 / Group 2)|1.1012|||||2-Sided|95.0|0.9992|1.2136|||||||
1688057|NCT01144416|3104942|Superiority or Other||||||>|0.999|||||||Fisher Exact||||
1688058|NCT01144416|3104943|Superiority or Other|||||||0.3|||||||Fisher Exact||||
1688059|NCT01144416|3104944|Non-Inferiority or Equivalence|The pre-defined non-inferiority margin was -8%|Difference in Live Birth Rates|-2.3|||||2-Sided|95.0|-6.5|1.9|||||||
1688060|NCT01144416|3104945|Non-Inferiority or Equivalence|The pre-defined non-inferiority margin was -3 oocytes.|Mean Difference (Final Values)|0.5|||||2-Sided|95.0|-0.2|1.2|||||||
1688061|NCT01144416|3104946|Non-Inferiority or Equivalence|The pre-defined non-inferiority margin was -8%|Difference in percentage vital pregnancy|-3.0|||||2-Sided|95.0|-7.4|1.4|||||||
1688062|NCT01144364|3104959|Superiority or Other||Hazard Ratio (HR)|0.62||||0.052|2-Sided|95.0|0.38|1.0|||Fine and Gray model|Fine and Gray model adjusted for stratification group, age, sex, Eastern Cooperative Oncology Group Performance Status, and FLIPI score|||
1688063|NCT01144364|3104959|Superiority or Other||Hazard Ratio (HR)|0.65||||0.084|2-Sided|95.0|0.39|1.06||Univariate analysis|Fine and Gray model|Fine and Gray model stratified for the stratification groups.|||
1688064|NCT01144364|3104960|Superiority or Other||Hazard Ratio (HR)|0.62||||0.071|2-Sided|95.0|0.37|1.04||Multivariate analysis|Regression, Cox|Adjusted for stratification group, age, sex, Eastern Cooperative Oncology Group Performance Status, FL International prognostic index (FLIPI) score.|||
1688065|NCT01144364|3104960|Superiority or Other||Hazard Ratio (HR)|0.66||||0.103|2-Sided|95.0|0.4|1.09||Univariate analysis|Regression, Cox|Cox model stratified for the stratification groups.|||
1688066|NCT01144364|3104963|Superiority or Other||Hazard Ratio (HR)|0.63||||0.079|2-Sided|95.0|0.38|1.05|||Cox proportional-hazards|||Analysis of overall PFS with Cox proportional-hazards model adjusted for the randomization stratum and the known prognostic factors.|
1688067|NCT01144364|3104965|Superiority or Other|||||||0.751|||||||Log Rank||||
1688068|NCT01144364|3104966|Superiority or Other|||||||0.751|||||||Log Rank||||
1690623|NCT01118455|3108498|Superiority or Other|||||||0.448|||||||t-test, 2 sided||||
1688069|NCT01144364|3104967|Superiority or Other||Hazard Ratio (HR)|0.58||||0.105|2-Sided|95.0|0.31|1.12||Overall DFS|Cox proportional-hazards|Adjusted for randomization stratum and the known prognostic factors.|||
1688070|NCT01144364|3104969|Superiority or Other|||||||0.254|||||||Log Rank|||Difference between treatment arms|
1688071|NCT01144338|3104970|Superiority|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1|Hazard Ratio (HR)|0.94||||0.485|2-Sided|95.0|0.78|1.13|||Regression, Cox||||
1688072|NCT01144338|3104971|Superiority|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1|Hazard Ratio (HR)|1.05||||0.402|2-Sided|95.0|0.94|1.18|||Regression, Cox||||
1688073|NCT01144338|3104972|Superiority|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1|Hazard Ratio (HR)|0.85||||0.095|2-Sided|95.0|0.7|1.03|||Regression, Cox||||
1688074|NCT01144338|3104973|Superiority|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1|Hazard Ratio (HR)|0.97||||0.622|2-Sided|95.0|0.85|1.1|||Regression, Cox||||
1688075|NCT01144338|3104974|Superiority|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1|Hazard Ratio (HR)|0.88||||0.096|2-Sided|95.0|0.76|1.02|||Regression, Cox||||
1688076|NCT01144338|3104975|Superiority|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1|Hazard Ratio (HR)|0.86||||0.016|2-Sided|95.0|0.77|0.97|||Regression, Cox||||
1688077|NCT01144338|3104976|Non-Inferiority|Non-inferiority test of EQW over Placebo H0: HR ≥ 1.3 vs. H1: HR < 1.3|Hazard Ratio (HR)|0.91|||<|0.001|2-Sided|95.0|0.832|1.004|||Regression, Cox|||This analysis uses the same endpoint and cox regression method as the primary efficacy analysis. However, the statistical hypothesis is a non-inferiority test with a margin of HR=1.3.|
1688078|NCT01144338|3104977|Superiority|Superiority test of EQW over Placebo H0: HR ≥ 1 vs. H1: HR < 1|Hazard Ratio (HR)|0.91||||0.061|2-Sided|95.0|0.832|1.004|||Regression, Cox||||
1688079|NCT01144286|3104988|Superiority or Other||response rate (%)|80.0||||0.063|2-Sided|95.0||||Significance level was set to α of 0.05 if the primary endpoint was significant, hierarchical testing was to be performed on the primary endpoint (each active dose X placebo). No other adjustment was made for testing multiple secondary outcomes.|Regression, Logistic|||"Primary analysis is the dose response at TOC based on the global therapeutic cure. Dose response will be tested using a logistic regression using linear coefficient for the treatment effect(Wald chi-square).~Assuming that the response rate is 80% for 600 mg, 75% for the 300 mg, 65% for 150 mg and 50% for the placebo group, a sample size of 45 subjects in each group will have 90% power to detect a linear dose response using a 0.05 two-sided test of trend based on the logistic model."|
1688080|NCT01144182|3104989|Superiority or Other|||||||0.36|||||||Wilcoxon (Mann-Whitney)||||
1688081|NCT01144182|3104990|Superiority or Other|||||||0.26|||||||Wilcoxon (Mann-Whitney)||||
1688082|NCT01144182|3104991|Superiority or Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)||||
1688083|NCT01144182|3104992|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1688084|NCT01144182|3104993|Superiority or Other|||||||0.56|||||||Wilcoxon (Mann-Whitney)||||
1688085|NCT01144182|3104994|Superiority or Other|||||||0.55|||||||Wilcoxon (Mann-Whitney)||||
1688086|NCT01144182|3104995|Superiority or Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)||||
1688087|NCT01144182|3104996|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)||||
1688088|NCT01144182|3104997|Superiority or Other|||||||0.008|||||||Wilcoxon (Mann-Whitney)||||
1688089|NCT01144182|3104998|Superiority or Other|||||||0.34|||||||Wilcoxon (Mann-Whitney)||||
1688090|NCT01144182|3104999|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1688091|NCT01144182|3105000|Superiority or Other|||||||0.22|||||||Wilcoxon (Mann-Whitney)||||
1688092|NCT01144182|3105001|Superiority or Other|||||||0.56||||||For this pilot study, significance level was set at p<0.05|Wilcoxon (Mann-Whitney)||||
1688093|NCT01144052|3105010|Non-Inferiority or Equivalence|No statistical hypothesis tests for efficacy were performed, as this was pilot study serving to generate first data and hypotheses.||||||0.234|||||||Wilcoxon (Mann-Whitney)|p-value refers to nT2L at month 12|||
1688094|NCT01144052|3105012|Superiority or Other|||||||0.206|||||||t-test, 2 sided||||
1688095|NCT01144052|3105013|Superiority or Other|||||||0.447|||||||non-parametric||||
1688096|NCT01144052|3105014|Superiority or Other|||||||0.447|||||||non-parametric||||
1688097|NCT01144052|3105015|Non-Inferiority or Equivalence|No statistical hypothesis tests for efficacy were performed as this was a pilot study serving to generate first data and hypotheses.||||||0.125|||||||Log Rank||||
1688098|NCT01143701|3105050|Superiority or Other||Mean Difference (Final Values)|-1.48|||<|0.05|2-Sided|95.0|-4.71|1.75|||Mixed Models Analysis|||An intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.|
1688099|NCT01143701|3105051|Superiority or Other||Mean Difference (Final Values)|-3.54|||<|0.05|2-Sided|95.0|-5.89|-1.19|||Mixed Models Analysis|||Utilizing the full sample (n=577), an intent-to-treat analyses was conducted comparing patient outcomes across intervention and control groups using a three-level mixed model. Baseline ratings were entered as a covariate. Post-baseline ratings collected closest to 12-months post-baseline were entered as dependent variables.|
1688100|NCT01143324|3105093|Superiority or Other||Mean|3.2|Standard Deviation|2.0||||95.0|2.9|3.4|||||||
1688101|NCT01143324|3105094|Superiority or Other||Percentage|42.7|||||||||||||||
1688102|NCT01143324|3105095|Superiority or Other||Difference from pre-op mean|-23.0|||<|0.0001|2-Sided|95.0|-25.5|-20.5|||t-test, 2 sided||||
1688103|NCT01143324|3105097|Superiority or Other||Percentage at 12 months|47.6|||||||||||||||
1688104|NCT01143324|3105098|Superiority or Other||Percentage|1.6|||||||||||||The rate of additional lumbar spinal surgeries at the same level was 1.6% (4/252) patients.||
1688105|NCT01143324|3105099|Superiority or Other||Percentage|1.2|||||||||||||The rate of additional lumbar spinal surgeries at treated level was 1.2% (3/252) patients.||
1688106|NCT01143324|3105100|Superiority or Other||Percentage|27.0|||||||||||||61/226 patients underwent a rehabilitation programs between 6 and 12 months follow up visit, making it 27.0 % of the total.||
1690624|NCT01118455|3108499|Superiority or Other|||||||0.036|||||||Wilcoxon (Mann-Whitney)||||
1688111|NCT01143272|3105109|Superiority or Other||Odds Ratio (OR)|1.0||||0.653|2-Sided|95.0|1.0|1.01||Association between the initial C-reactive protein and incidence of AAD|Regression, Logistic||||
1688112|NCT01143272|3105109|Superiority or Other||Odds Ratio (OR)|1.02||||0.6|2-Sided|95.0|0.96|1.08||Association between initial leukocyte count and incidence of AAD|Regression, Logistic||||
1688113|NCT01143272|3105110|Superiority or Other||Hazard Ratio (HR)|1.03||||0.93|2-Sided|95.0|0.53|2.03||adjusting for age, sex, CRP, leukocyte count, duration of antibiotic treatment, and administration of antibiotics|Regression, Cox||||
1688114|NCT01143272|3105110|Superiority or Other||Hazard Ratio (HR)|0.92||||0.8|2-Sided|95.0|0.49|1.73|||Regression, Cox||||
1688115|NCT01143272|3105112|Superiority or Other|||||||0.87|||||||Log Rank||||
1688116|NCT01143272|3105112|Superiority or Other|||||||0.25|||||||Fisher Exact||||
1688117|NCT01143272|3105112|Superiority or Other||Hazard Ratio (HR)|1.02||||0.94|2-Sided|95.0|0.55|1.9|||Regression, Cox||||
1688118|NCT01143038|3105147|Superiority or Other||Bootstrap mean|9.1|Standard Error of the Mean|0.4|||2-Sided|95.0|8.3|10.0|||||Estimates are based on bootstrap method with 1000 samples with replacement.|Bootstrap analysis|
1688119|NCT01143038|3105147|Superiority or Other||Mean|9.2|||||2-Sided|95.0|8.3|10.1|||||Based on the t-distribution||
1688120|NCT01142908|3105149|Superiority or Other||Mean Difference (Net)|-0.1||||0.72|2-Sided|95.0|-0.5|0.4|||Mixed Models Analysis|Adjusted for gender and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months|
1688121|NCT01142908|3105150|Superiority or Other||Mean Difference (Net)|-0.2||||0.29|2-Sided|95.0|-0.6|0.2|||Mixed Models Analysis|Adjusted for gender and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months|
1688122|NCT01142908|3105152|Superiority or Other||Mean Difference (Net)|-0.1||||0.54|2-Sided|95.0|-0.4|0.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.|
1688123|NCT01142908|3105153|Superiority or Other||Mean Difference (Net)|-0.02||||0.83|2-Sided|95.0|-0.2|0.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months|
1688124|NCT01142908|3105155|Superiority or Other||Mean Difference (Net)|-0.8||||0.79|2-Sided|95.0|-6.6|5.0|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.|
1688125|NCT01142908|3105156|Superiority or Other||Mean Difference (Net)|-4.9||||0.08|2-Sided|95.0|-10.3|0.6|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months|
1688126|NCT01142908|3105158|Superiority or Other||logit-difference (Net)|0.2||||0.36|2-Sided|95.0|-0.2|0.5|||Gen. Est. Equation with a Logit Link|Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.|
1688127|NCT01142908|3105159|Superiority or Other||logit-difference (Net)|-0.03||||0.87|2-Sided|95.0|-0.4|0.3|||Gen. Est. Equation with a Logit Link|Method Used Expanded: Generalized Estimating Equation with a Logit Link. Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months|
1688128|NCT01142908|3105161|Superiority or Other||Mean Difference (Net)|-0.3||||0.74|2-Sided|95.0|-2.4|1.7|||Mixed Models Analysis||Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months|
1688129|NCT01142908|3105162|Superiority or Other||Mean Difference (Net)|-1.8||||0.1|2-Sided|95.0|-3.9|0.3|||Mixed Models Analysis||Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months|
1688130|NCT01142908|3105163|Superiority or Other||Mean Difference (Net)|0.4||||0.7|2-Sided|95.0|-1.5|2.2|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.|
1688131|NCT01142908|3105164|Superiority or Other||Mean Difference (Net)|-0.1||||0.91|2-Sided|95.0|-2.0|1.8|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months|
1688132|NCT01142908|3105166|Superiority or Other||Mean Difference (Net)|1.4||||0.34|2-Sided|95.0|-1.5|4.3|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 12 months.|
1688133|NCT01142908|3105167|Superiority or Other||Mean Difference (Net)|0.1||||0.93|2-Sided|95.0|-2.8|3.1|||Mixed Models Analysis|Adjusted for gender, diabetes, and smoking status stratification variables|Direction of the test of comparison is Pharmacist Intervention minus Control|Comparison at 6 months|
1688134|NCT01142726|3105189|Superiority or Other||Odds Ratio (OR)|2.04|Standard Error of the Mean|0.96|||2-Sided|95.0|0.81|5.14|||||At Months 12 and 18||
1688135|NCT01142726|3105189|Superiority or Other||Odds Ratio (OR)|0.92|Standard Error of the Mean|0.25|||2-Sided|95.0|0.55|1.57|||||At Month 12||
1688136|NCT01142726|3105190|Superiority or Other||Odds Ratio (OR)|2.51|Standard Error of the Mean|1.15||0.045|2-Sided|95.0|1.02|6.18|||Regression, Logistic|Statistical testing of the 2 coprimary efficacy endpoints was conducted in a hierarchical fashion to maintain the overall Type I error rate at 5%.|At Months 12 and 18|Conditional on statistical significance of the 1st coprimary efficacy analysis (CEA), a sample of 116 patients per arm would provide 98% power for the 2nd CEA comparison of the percentage of patients in DAS28-CRP remission at Months 12 and 18 between the abatacept (ABA)+methotrexate (MTX) arm and the MTX monotherapy arm for intent-to treat population. This sample size calculation assumed 30% remission in the ABA+MTX arm and 8% in the monotherapy arm at Month 18 and a 2-sided alpha level of 5%.|
1688169|NCT01140906|3105316|Superiority or Other||Mean Difference (Final Values)|-6.93|Standard Error of the Mean|1.13|<|0.0001|2-Sided|95.0|-9.16|-4.7||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM||||
1688137|NCT01142726|3105190|Superiority or Other||Odds Ratio (OR)|2.01|Standard Error of the Mean|0.55||0.01|2-Sided|95.0|1.18|3.43|||Regression, Logistic|Statistical testing of the 2 coprimary efficacy endpoints was conducted in a hierarchical fashion to maintain the overall Type I error rate at 5%.|At Month 12|Power estimate assumed 2-sided alpha level of 5% and that 60% of abatacept (ABA)+methotrexate (MX) patients (pts) would be in DAS28-CRP remission at Month 12 compared with 38% of MX monotherapy pts. Also assumed that 48% of ABA monotherapy pts would be in DAS28-CRP remission at Month 12, yielding an expected treatment difference from MX of 10% in favor of ABA monotherapy; 116 pts randomized to ABA monotherapy would yield a half-length of the 95% CI around that 10% treatment difference of 13.5%.|
1688138|NCT01142466|3105221|Superiority or Other|||||||0.2635|||||||Fisher Exact||||
1688139|NCT01142466|3105222|Superiority or Other|||||||0.1384|||||||Log Rank|||Two-sided log rank test with alpha equal to 0.05 was used as the appropriate nonparametric method to compare the two groups.|
1688140|NCT01142388|3105224|Superiority or Other (legacy)|||||||0.5|||||||Log Rank|one-sided stratified log rank test, stratifying on 1) gastroesophageal junction vs. esophagus, 2) squamous cell carcinoma vs. adenocarcinoma.|||
1688141|NCT01142388|3105225|Superiority or Other (legacy)|||||||0.85|||||||Log Rank|one-sided stratified log rank test, stratifying on: 1) gastroesophageal junction vs. esophagus, 2) squamous cell carcinoma vs. adenocarcinoma.|||
1688142|NCT01142336|3105226|Superiority|||||||0.25||||||Threshold for significance: 0.05, adjusted for 3 primary outcomes using Holm correction.|ANCOVA|Response variable was p-tau181 in CSF at 1 year, and predictor were p-tau181 in at baseline, treatment group, age, sex, and APOE e4 allele status|||
1688143|NCT01142336|3105227|Superiority|||||||0.36||||||Threshold for significance: 0.05, adjusted for 3 primary outcomes using Holm correction|ANCOVA|Response variable was total tau in CSF at 1 year, and predictor were total tau in at baseline, treatment group, age, sex, and APOE e4 allele status|||
1688144|NCT01142336|3105228|Superiority|||||||0.53||||||Threshold for significance: 0.05, adjust for 3 primary outcomes using Holm Correction|ANCOVA|Response variable was Aβ42 in CSF at 1 year, and predictor variables were Aβ42 in CSF at baseline, treatment group, age, sex, and APOE e4 allele.|||
1688145|NCT01142323|3105229|Superiority|||||||0.46|||||||Wilcoxon (Mann-Whitney)||||
1688146|NCT01142323|3105230|Superiority or Other|||||||0.008|||||||Matched pairs||||
1688147|NCT01142193|3105237|Superiority or Other||Difference in Percentages|13.4||||0.048|||||||Cochran-Mantel-Haenszel|Analysis was stratified by Geographic Region.|||
1688148|NCT01142193|3105238|Superiority or Other||Median Difference (Net)|23.61||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1688149|NCT01142193|3105242|Superiority or Other||Median Difference (Net)|17.85|||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1688150|NCT01142193|3105243|Superiority or Other||Median Difference (Net)|25.36|||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1688151|NCT01142193|3105244|Superiority or Other||Difference in Percentages|16.3||||0.007|||||||Cochran-Mantel-Haenszel|Analysis was stratified by Geographic Region.|||
1688152|NCT01142193|3105245|Superiority or Other||Difference in Percentages|14.7||||0.013|||||||Fisher Exact||||
1688153|NCT01142193|3105246|Superiority or Other||Median Difference (Net)|18.5|||||2-Sided|95.0|8.53|28.1|||||||
1688154|NCT01142193|3105246|Superiority or Other||Median Difference (Net)|17.85|||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1688155|NCT01142115|3105251|Superiority or Other||Odds Ratio (OR)|1.398||||0.4324|2-Sided|95.0|0.606|3.225|||Proportional odds regression model||||
1688156|NCT01142115|3105252|Superiority or Other||Odds Ratio (OR)|3.503||||0.3085|2-Sided|95.0|0.314|39.106|||Regression, Logistic||||
1688157|NCT01142115|3105253|Superiority or Other||Odds Ratio (OR)|1.117||||0.8014|2-Sided|95.0|0.472|2.646|||Proportional odds regression model||||
1688158|NCT01142115|3105254|Superiority or Other||Odds Ratio (OR)|0.822||||0.616|2-Sided|95.0|0.382|1.767|||Proportional odds regression model||||
1688159|NCT01142115|3105255|Superiority or Other||Odds Ratio (OR)|5.805|||<|0.0001|2-Sided|95.0|2.604|12.939|||Regression, Logistic||||
1688160|NCT01142115|3105256|Non-Inferiority or Equivalence|The estimated difference VAS(Monza) minus VAS(SpeediCath)(i.e. the upper confidence limit) shall be less than 1cm to demonstrate non-inferiority.|Mean Difference (Final Values)|1.052||||0.0018|2-Sided|95.0|0.412|1.692|||Mixed Models Analysis||||
1688161|NCT01141647|3105288|Superiority or Other||Odds Ratio (OR)|3.56|||||2-Sided|90.0|1.8|7.07|||||||
1688162|NCT01141608|3105295|Superiority or Other||||||<|0.05|||||||Linear mixed effects model||||
1688163|NCT01141374|3105305|Superiority or Other||Mean Difference (Final Values)|-7.9067|Standard Deviation|19.21||0.023|2-Sided|95.0|-67.0|37.0||It was verified the normality of data distribution and the homogeneity of variance.|ANOVA|As for the comparison between the scores, we used ANOVA for repeated measures.It was made post hoc to find the differences among groups.||It was carried out the analysis of variance (ANOVA) among the groups in the 3rd assessment (after 60 days and 8 sessions). The main objective was to compare the difference among the control group, seeds and needles and to recognize significant outcomes of auriculotherapy by seeds or needles.|
1688164|NCT01141374|3105306|Superiority or Other||Mean Difference (Final Values)|-8.0667|Standard Deviation|17.28||0.352|2-Sided|95.0|-76.0|23.0||The test of hypothesis was conducted with repeated measures ANOVA with Post hoc. It was performed parametric test to compare data and the statistical significance was p<0.05.|ANOVA|||Null hypothesis: there was no statistical difference among 3 groups (control, needles and seeds) after 4 auriculotherapy sessions.|
1688165|NCT01140906|3105314|Superiority or Other||Mean Difference (Final Values)|0.56|Standard Error of the Mean|0.41||0.169|2-Sided|95.0|-0.24|1.37||A nominal p-value is provided.|ANCOVA||||
1688166|NCT01140906|3105314|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.41||0.7372|2-Sided|95.0|-0.95|0.67||A nominal p-value is provided.|ANCOVA||||
1688167|NCT01140906|3105315|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.59||0.4186|2-Sided|95.0|-1.64|0.68||A nominal p-value is provided.|MMRM||No correction for multiplicity was made.||
1688168|NCT01140906|3105315|Superiority or Other||Mean Difference (Final Values)|-0.67|Standard Error of the Mean|0.59||0.2524|2-Sided|95.0|-1.83|0.48||A nominal p-value is provided.|MMRM||No correction for multiplicity was made.||
1688170|NCT01140906|3105316|Superiority or Other||Mean Difference (Final Values)|-3.92|Standard Error of the Mean|1.11|<|0.0005|2-Sided|95.0|-6.11|-1.73||Since p-value <0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1688171|NCT01140906|3105316|Superiority or Other||Mean Difference (Final Values)|-3.24|Standard Error of the Mean|1.16|<|0.0054|2-Sided|95.0|-5.51|-0.97||Since p-value <0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1688172|NCT01140906|3105317|Superiority or Other||Odds Ratio (OR)|5.01|||<|0.0001|2-Sided|95.0|2.99|8.37||Wald's test. This treatment arm was not in the testing sequence. A nominal p-value is provided.|Adjusted for Odds Ratio||||
1688173|NCT01140906|3105317|Superiority or Other||Odds Ratio (OR)|2.65|||<|0.0002|2-Sided|95.0|1.58|4.44||Wald's test. Since p-value <0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1688174|NCT01140906|3105317|Superiority or Other||Odds Ratio (OR)|2.32|||<|0.0016|2-Sided|95.0|1.37|3.91||Wald's test. Since p-value <0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1688175|NCT01140906|3105318|Superiority or Other||Mean Difference (Final Values)|-8.71|Standard Error of the Mean|1.54|<|0.0001|2-Sided|95.0|-11.73|-5.69||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM||||
1688176|NCT01140906|3105318|Superiority or Other||Mean Difference (Final Values)|-6.42|Standard Error of the Mean|1.58|<|0.0001|2-Sided|95.0|-9.53|-3.31||Since p-value <0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1688177|NCT01140906|3105318|Superiority or Other||Mean Difference (Final Values)|-5.24|Standard Error of the Mean|1.53|<|0.0007|2-Sided|95.0|-8.25|-2.22||Since p-value <0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1688178|NCT01140906|3105319|Superiority or Other||Mean Difference (Final Values)|-1.12|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-1.36|-0.87||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM||||
1688179|NCT01140906|3105319|Superiority or Other||Mean Difference (Final Values)|-0.95|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-1.2|-0.7||Since p-value <0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1688180|NCT01140906|3105319|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-0.94|-0.44||Since p-value <0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1688181|NCT01140906|3105320|Superiority or Other||Odds Ratio (OR)|5.94|||<|0.0001|2-Sided|95.0|3.61|9.78||This treatment arm was not in the testing sequence. A nominal p-value is provided.|Adjusted Odds Ratio||||
1688182|NCT01140906|3105320|Superiority or Other||Odds Ratio (OR)|3.36|||<|0.0001|2-Sided|95.0|2.1|5.36||Wald's test. Since p-value <0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1688183|NCT01140906|3105320|Superiority or Other||Odds Ratio (OR)|2.8|||<|0.0001|2-Sided|95.0|1.76|4.47||Wald's test. Since p-value <0.025, hierarchically testing continued.|Adjusted Odds Ratio||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1688184|NCT01140906|3105321|Superiority or Other||Mean Difference (Final Values)|-9.45|Standard Error of the Mean|1.07|<|0.0001|2-Sided|95.0|-11.55|-7.35||This treatment arm was not in the testing sequence. A nominal p-value is provided.|MMRM||||
1688185|NCT01140906|3105321|Superiority or Other||Mean Difference (Final Values)|-7.09|Standard Error of the Mean|1.08|<|0.0001|2-Sided|95.0|-9.21|-4.97||Since p-value <0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1688206|NCT01139762|3105412|Superiority or Other|||||||0.328||||||P-value is for overall distribution of responses.|Cochran-Mantel-Haenszel|Adjusted for baseline lower urinary tract symptoms (LUTS) severity.|||
1688186|NCT01140906|3105321|Superiority or Other||Mean Difference (Final Values)|-5.53|Standard Error of the Mean|1.09|<|0.0001|2-Sided|95.0|-7.66|-3.4||Since p-value <0.025, hierarchically testing continued.|MMRM||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1688187|NCT01140646|3105347|Superiority or Other|||||||0.1553||||||One sided t-test with 0.05 error rate was employed.|t-test, 1 sided|||To determine whether any reduction in hot flash frequency is beyond what is expected with a placebo (20-25%). Reference: Sloan JA, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. Dec 1 2001;19(23):4280-4290.|
1688188|NCT01140646|3105347|Superiority or Other|||||||0.0903||||||One sided t-test with 0.05 error rate was employed.|t-test, 1 sided|||To determine whether any reduction in hot flash score is beyond what is expected with a placebo (20-25%). Reference: Sloan JA, et al. Methodologic lessons learned from hot flash studies. J Clin Oncol. Dec 1 2001;19(23):4280-4290.|
1688189|NCT01140347|3105364|Superiority or Other||Hazard Ratio (HR)|0.593|||<|0.0001|2-Sided|95.0|0.487|0.722|||Log Rank||HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).||
1688190|NCT01140347|3105365|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for geographic region and etiology liver disease|||
1688191|NCT01140347|3105366|Superiority or Other||Hazard Ratio (HR)|0.625|||<|0.0001|2-Sided|95.0|0.522|0.75|||Log Rank||HR with 95% CI was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors (geographical regions and etiology of liver disease).||
1688192|NCT01140347|3105367|Superiority or Other||Hazard Ratio (HR)|0.866||||0.1391|2-Sided|95.0|0.717|1.046|||Log Rank||HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the Interactive Web Response System (IWRS) stratification factors (geographical regions and etiology of liver disease).||
1688193|NCT01139801|3105393|Superiority||Mean Difference (Final Values)|212.2||||0.037|2-Sided|95.0|13.3|411.0|||t-test, 2 sided||||
1688194|NCT01139775|3105394|Superiority or Other|||||||0.0946||||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Chi-squared||||
1688195|NCT01139775|3105405|Superiority or Other|||||||0.4924||||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Wilcoxon (Mann-Whitney)||||
1688196|NCT01139775|3105406|Superiority or Other|||||||0.0824||||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Chi-squared||||
1688197|NCT01139775|3105407|Superiority or Other|||||||0.2294||||||The test of treatment effect was conducted at a 2-sided alpha level of 0.10.|Log Rank||||
1688198|NCT01139775|3105409|Superiority or Other||Bayesian Posterior Probability|0.96|||||2-Sided||||||||Pemetrexed + cisplatin + LY2603618 was considered superior to pemetrexed + cisplatin if the posterior probability of superiority exceeded 0.85.|The analysis for comparing progression-free survival time between the treatment arms used a Bayesian Augmented Control model with a hierarchical random-effects distribution on treatment effects. The final model incorporated historical data from a completed Phase 3 study (NCT00789373) to augment the prospective control arm data.|
1688199|NCT01139762|3105410|Superiority or Other||LS Mean Difference|0.62|||<|0.001|2-Sided|95.0|0.35|0.89||P-value is for Question 4 - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688200|NCT01139762|3105410|Superiority or Other||LS Mean Difference|0.61|||<|0.001|2-Sided|95.0|0.36|0.85||P-value is for Question 4 - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688201|NCT01139762|3105410|Superiority or Other||LS Mean Difference|0.71|||<|0.001|2-Sided|95.0|0.46|0.95||P-value is for Question 4 - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688202|NCT01139762|3105410|Superiority or Other||LS Mean Difference|0.75|||<|0.001|2-Sided|95.0|0.48|1.02||P-value is for Question 3 - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688203|NCT01139762|3105410|Superiority or Other||LS Mean Difference|0.68|||<|0.001|2-Sided|95.0|0.43|0.93||P-value is for Question 3 - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688204|NCT01139762|3105410|Superiority or Other||LS Mean Difference|0.74|||<|0.001|2-Sided|95.0|0.49|0.98||P-value is for Question 3 - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688205|NCT01139762|3105411|Superiority or Other|||||||0.157|||||||Wilcoxon Rank-Sum test||||
1688208|NCT01139762|3105414|Superiority or Other|||||||0.034||||||P-value is for overall distribution of responses.|Cochran-Mantel-Haenszel|Adjusted for baseline lower urinary tract symptoms (LUTS) severity.|||
1688209|NCT01139762|3105415|Superiority or Other||LS Mean Difference|0.76|||<|0.001|2-Sided|95.0|0.39|1.13||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688210|NCT01139762|3105415|Superiority or Other||LS Mean Difference|0.79|||<|0.001|2-Sided|95.0|0.44|1.14||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688211|NCT01139762|3105415|Superiority or Other||LS Mean Difference|0.93|||<|0.001|2-Sided|95.0|0.61|1.25||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688212|NCT01139762|3105416|Superiority or Other||LS Mean Difference|1.07||||0.002|2-Sided|95.0|0.41|1.74||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688213|NCT01139762|3105416|Superiority or Other||LS Mean Difference|0.9||||0.006|2-Sided|95.0|0.27|1.54||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688214|NCT01139762|3105416|Superiority or Other||LS Mean Difference|1.53|||<|0.001|2-Sided|95.0|0.92|2.13||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688215|NCT01139762|3105417|Superiority or Other||LS Mean Difference|1.98|||<|0.001|2-Sided|95.0|1.23|2.73||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688216|NCT01139762|3105417|Superiority or Other||LS Mean Difference|1.59|||<|0.001|2-Sided|95.0|0.88|2.31||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688217|NCT01139762|3105417|Superiority or Other||LS Mean Difference|1.82|||<|0.001|2-Sided|95.0|1.18|2.47||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688218|NCT01139762|3105418|Superiority or Other||LS Mean Difference|1.22|||<|0.001|2-Sided|95.0|0.74|1.69||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688219|NCT01139762|3105418|Superiority or Other||LS Mean Difference|1.06|||<|0.001|2-Sided|95.0|0.61|1.51||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688220|NCT01139762|3105418|Superiority or Other||LS Mean Difference|1.01|||<|0.001|2-Sided|95.0|0.61|1.4||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688221|NCT01139762|3105419|Superiority or Other||LS Mean Difference|4.73|||<|0.001|2-Sided|95.0|3.15|6.31||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1690625|NCT01118455|3108499|Superiority or Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1688222|NCT01139762|3105419|Superiority or Other||LS Mean Difference|4.08|||<|0.001|2-Sided|95.0|2.55|5.6||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688223|NCT01139762|3105419|Superiority or Other||LS Mean Difference|4.85|||<|0.001|2-Sided|95.0|3.49|6.21||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688224|NCT01139762|3105420|Superiority or Other||LS Mean Difference|-0.17||||0.107|2-Sided|95.0|-0.38|0.04||P-value is for 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688225|NCT01139762|3105420|Superiority or Other||LS Mean Difference|-0.19||||0.051|2-Sided|95.0|-0.38|0.0||P-value is for 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688226|NCT01139762|3105420|Superiority or Other||LS Mean Difference|-0.32|||<|0.001|2-Sided|95.0|-0.5|-0.14||P-value is for 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688227|NCT01139762|3105421|Superiority or Other||LS Mean Difference|-0.73||||0.015|2-Sided|95.0|-1.32|-0.14||P-value is IPSS voiding (obstructive) subscore - 26 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688228|NCT01139762|3105421|Superiority or Other||LS Mean Difference|-1.04|||<|0.001|2-Sided|95.0|-1.62|-0.46||P-value is for IPSS voiding (obstructive) subscore - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688229|NCT01139762|3105421|Superiority or Other||LS Mean Difference|-1.18|||<|0.001|2-Sided|95.0|-1.69|-0.68||P-value is for IPSS voiding (obstructive) subscore - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688230|NCT01139762|3105421|Superiority or Other||LS Mean Difference|-0.34|||<|0.107|2-Sided|95.0|-0.75|0.07||P-value is for IPSS storage (irritative) subscore - 26 weeks|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688231|NCT01139762|3105421|Superiority or Other||LS Mean Difference|-0.41|||<|0.04|2-Sided|95.0|-0.8|-0.02||P-value is for IPSS storage (irritative) subscore - 12 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688232|NCT01139762|3105421|Superiority or Other||LS Mean Difference|-0.51|||<|0.007|2-Sided|95.0|-0.87|-0.14||P-value is for IPSS storage (irritative) subscore - 4 weeks.|Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688233|NCT01139762|3105423|Superiority or Other||LS Mean Difference|-1.41||||0.001|2-Sided|95.0|-2.27|-0.55|||Mixed Model Repeated Measures Analysis|The Kenward-Roger approximation was used to estimate denominator degrees of freedom.||MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.|
1688234|NCT01139580|3105442|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1688235|NCT01139580|3105445|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1688269|NCT01138657|3105510|Superiority or Other||Mean Difference|10.02|||<|0.001|2-Sided|95.0|4.86|15.19|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688236|NCT01139515|3105448|Superiority or Other||Adjusted ratio of geometric means|107.44|||||2-Sided|90.0|90.72|127.25||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."|
1688237|NCT01139515|3105448|Superiority or Other||Adjusted ratio of geometric means|98.57|||||2-Sided|90.0|83.23|116.73||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."|
1688238|NCT01139515|3105448|Superiority or Other||Adjusted geometric means ratio|101.81|||||2-Sided|90.0|85.97|120.58||||||"Natural log transformed, dose-normalized Cmax of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.~The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios."|
1688239|NCT01139515|3105449|Superiority or Other||Adjusted ratio of geometric means|110.44|||||2-Sided|90.0|103.28|118.09||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1688240|NCT01139515|3105449|Superiority or Other||Adjusted ratio of geometric means|110.52|||||2-Sided|90.0|103.36|118.18||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1688241|NCT01139515|3105449|Superiority or Other||Adjusted geometric means ratio|99.41|||||2-Sided|90.0|92.97|106.31||||||Natural log transformed, dose-normalized AUClast of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1688242|NCT01139515|3105450|Superiority or Other||Adjusted ratio of geometric means|109.93|||||2-Sided|90.0|102.65|117.72||||||Natural log transformed, dose-normalized AUC[0- ∞] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1688243|NCT01139515|3105450|Superiority or Other||Adjusted ratio of geometric means|109.48|||||2-Sided|90.0|102.23|117.24||||||Natural log transformed, dose-normalized AUC[0- ∞] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1688244|NCT01139515|3105450|Superiority or Other||Adjusted ratio of geometric means|98.7|||||2-Sided|90.0|92.17|105.7||||||Natural log transformed, dose-normalized AUC[0- ∞] of eletriptan was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1688245|NCT01139411|3105455|Superiority or Other|||||||0.61||||||Threshold for significance: 0.05|ANCOVA||||
1688246|NCT01139411|3105456|Superiority or Other|||||||0.01||||||Threshold for significance: 0.05|ANCOVA||||
1688247|NCT01139411|3105457|Superiority or Other|||||||0.41|||||||ANCOVA||||
1688248|NCT01139411|3105458|Superiority or Other|||||||0.72||||||Threshold for significance: 0.05|ANCOVA||||
1688249|NCT01139411|3105459|Superiority or Other|||||||0.19||||||Threshold for significance: 0.05|ANCOVA||||
1688250|NCT01139411|3105460|Superiority or Other|||||||0.58||||||Threshold for significance: 0.05|ANCOVA|||The end-of-treatment value was the dependent variable, with the baseline value entered as a covariate.|
1688251|NCT01139411|3105461|Superiority or Other|||||||0.06||||||Threshold for significance: 0.05|ANCOVA|||"Null hypothesis was that the amount of weight lost by adolescents in Enhanced Parent Involvement and Minimal Parent involvement would not be significantly different. The study was powered at .8 to achieve a medium effect size (f = .26; partial eta sq. = 0.06).~The end-of-treatment BMI value was the dependent variable, with the baseline BMI value entered as a covariate."|
1688252|NCT01138995|3105490|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1688253|NCT01138995|3105491|Superiority or Other||||||<|0.022|||||||Wilcoxon (Mann-Whitney)||||
1688254|NCT01138995|3105492|Superiority or Other|||||||0.75|||||||Fisher's combination test|Between group difference for entire sample|||
1688255|NCT01138826|3105503|Non-Inferiority or Equivalence|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|96.77|||||2-Sided|90.0|89.58|104.54||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.|
1688270|NCT01138657|3105511|Superiority or Other||Mean Difference|4.14||||0.077|2-Sided|95.0|-0.45|8.72|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688256|NCT01138826|3105503|Non-Inferiority or Equivalence|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|95.22|||||2-Sided|90.0|88.16|102.84||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.|
1688257|NCT01138826|3105503|Non-Inferiority or Equivalence|Natural log transformed Cmax of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|98.39|||||2-Sided|90.0|91.05|106.33||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1146 on the natural log scale for Cmax with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1366 for loge Cmax.|
1688258|NCT01138826|3105504|Non-Inferiority or Equivalence|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|100.37|||||2-Sided|90.0|94.02|107.15|||||||
1688259|NCT01138826|3105504|Non-Inferiority or Equivalence|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|104.26|||||2-Sided|90.0|97.67|111.3|||||||
1688260|NCT01138826|3105504|Non-Inferiority or Equivalence|Natural log transformed AUClast of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|103.88|||||2-Sided|90.0|97.27|110.94|||||||
1688261|NCT01138826|3105505|Non-Inferiority or Equivalence|Natural log transformed AUC[0- ∞] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|101.88|||||2-Sided|90.0|94.7|109.6||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.|
1688262|NCT01138826|3105505|Non-Inferiority or Equivalence|Natural log transformed AUC[0- ∞] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|107.55|||||2-Sided|90.0|99.98|115.69||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.|
1688263|NCT01138826|3105505|Non-Inferiority or Equivalence|Natural log transformed AUC[0- ∞] of amlodipine was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|Adjusted ratio of geometric means|105.57|||||2-Sided|90.0|98.09|113.61||||||A sample size of 12 completers provided 90% confidence intervals for the difference between treatment of +/-0.1036 on the natural log scale for AUCinf with 90% coverage probability. These calculations were based on estimates of within-participant standard deviations of 0.1234 for loge AUCinf.|
1688264|NCT01138735|3105506|Superiority or Other||||||<|0.001|||||||ANCOVA|Ranked Change in Inflammatory Lesion Counts = Ranked Baseline Inflammatory Lesion Counts, Analysis Center, Treatment|||
1688265|NCT01138735|3105507|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test with row mean difference statistic using relative to an identified distribution(RIDIT) score, controlling for analysis center|||
1688266|NCT01138735|3105508|Superiority or Other||||||<|0.001||||||No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed ‘positive’ if all primary analyses are shown statistically significant at the 0.05 level.|ANCOVA|normality assumption is not met. ANCOVA Model: Ranked Change in Total Lesion Counts = Ranked Baseline Lesion Counts, Analysis Center, Treatment.||null hypothesis: no difference in change from baseline in total lesion count in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle)|
1688267|NCT01138735|3105509|Superiority or Other||||||<|0.001||||||No adjustment for multiplicity is required. The tests will be conducted as two-sided, each at the 0.05 significance level. The trial will be claimed ‘positive’ if all primary analyses are shown statistically significant at the 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by analysis center, using general association statistics||"null hypothesis: no difference in Success rate in two treatment groups (adapalene/benzoyl peroxide vs Topical Gel Vehicle).~power calculation: 90%"|
1688268|NCT01138657|3105510|Superiority or Other||Mean Difference|8.83|||<|0.001|2-Sided|95.0|3.88|13.79|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%|
1690626|NCT01118455|3108499|Superiority or Other|||||||0.217|||||||Wilcoxon (Mann-Whitney)||||
1688271|NCT01138657|3105511|Superiority or Other||Mean Difference|5.12||||0.036|2-Sided|95.0|0.34|9.9|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688272|NCT01138657|3105512|Superiority or Other||Mean Difference|1.31||||0.496|2-Sided|95.0|-2.47|5.09|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688273|NCT01138657|3105512|Superiority or Other||Mean Difference|1.86||||0.346|2-Sided|95.0|-2.03|5.75|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688274|NCT01138657|3105513|Superiority or Other||Mean Difference|3.67||||0.019|2-Sided|95.0|0.62|6.71|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688275|NCT01138657|3105513|Superiority or Other||Mean Difference|4.2||||0.01|2-Sided|95.0|1.02|7.38|||ANOVA|ANOVA with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688276|NCT01138657|3105514|Superiority or Other||Mean Difference|-5.1||||0.428|2-Sided|95.0|-17.7|7.5|||Chi-squared, Corrected|ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688277|NCT01138657|3105514|Superiority or Other||Mean Difference|-11.4||||0.02|2-Sided|95.0|-20.9|-1.8|||ANOVA|ANOVA with treatment and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688278|NCT01138657|3105515|Superiority or Other||Hazard Ratio (HR)|0.68||||0.191|2-Sided|95.0|0.38|1.21|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688279|NCT01138657|3105515|Superiority or Other||Hazard Ratio (HR)|0.7||||0.231|2-Sided|95.0|0.39|1.26|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688280|NCT01138657|3105516|Superiority or Other||Mean Difference|-0.06||||0.008|2-Sided|95.0|-0.1|-0.02|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688281|NCT01138657|3105516|Superiority or Other||Mean Difference|-0.07||||0.003|2-Sided|95.0|-0.11|-0.02|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688282|NCT01138657|3105517|Superiority or Other||Mean Difference|-0.28|||<|0.001|2-Sided|95.0|-0.43|-0.12|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688283|NCT01138657|3105517|Superiority or Other||Mean Difference|-0.27|||<|0.001|2-Sided|95.0|-0.43|-0.11|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688284|NCT01138657|3105518|Superiority or Other||Mean Difference|-0.25||||0.019|2-Sided|95.0|-0.46|-0.04|||ANOVA|ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations (from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688285|NCT01138657|3105518|Superiority or Other||Mean Difference|-0.29||||0.011|2-Sided|95.0|-0.51|-0.07|||ANOVA|ANOVA with treatment as factor adjusted for clustered observations (i.e., observations from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1688286|NCT01138657|3105519|Superiority or Other||Hazard Ratio (HR)|0.56|||<|0.001|2-Sided|95.0|0.4|0.76|||Log Rank|||An additional analysis of the primary endpoint was performed using the Integrated Study data (Main Study + Japan sub-study). The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|
1688312|NCT01138124|3105543|Superiority or Other||Unadjusted Odds Ratio|2.54||||0.042|2-Sided|95.0|1.03|6.25|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688287|NCT01138657|3105519|Superiority or Other||Hazard Ratio (HR)|0.5|||<|0.001|2-Sided|95.0|0.36|0.7|||Log Rank|||The primary analysis of the primary endpoint was performed on Main Study data, excluding the Japanese sub-study. The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|
1688288|NCT01138514|3105520|Non-Inferiority or Equivalence|Clinical success was defined as a score of clear (0) or almost clear (1) on Investigator‟s Global Assessment (IGA) at Visit 4/Week 10|equivalence difference|1.6||||0.05|2-Sided|90.0|-4.2|7.4|||Wald's method Yates' continuity correct||||
1688289|NCT01138514|3105521|Non-Inferiority or Equivalence|provides 85% power of success|equivalence ratio|100.27||||0.05|2-Sided|90.0|95.6|105.2|||Fieller's method||||
1688290|NCT01138514|3105522|Non-Inferiority or Equivalence|provides 85% power of success|equivalence ratio|98.77||||0.05|2-Sided|90.0|95.2|102.5|||Fieller's method||||
1688291|NCT01138124|3105542|Superiority or Other||Adjusted Odds Ratio|1.15||||0.8173|2-Sided|95.0|0.34|3.86|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688292|NCT01138124|3105542|Superiority or Other||Unadjusted Odds Ratio|1.15||||0.8135|2-Sided|95.0|0.35|3.82|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688293|NCT01138124|3105542|Superiority or Other||Adjusted Odds Ratio|0.91||||0.8206|2-Sided|95.0|0.39|2.13|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688294|NCT01138124|3105542|Superiority or Other||Unadjusted Odds Ratio|0.99||||0.9723|2-Sided|95.0|0.42|2.29|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688295|NCT01138124|3105542|Superiority or Other||Adjusted Odds Ratio|1.7||||0.2899|2-Sided|95.0|0.64|4.53|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688296|NCT01138124|3105542|Superiority or Other||Unadjusted Odds Ratio|1.78||||0.2421|2-Sided|95.0|0.68|4.69|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688297|NCT01138124|3105542|Superiority or Other||Adjusted Odds Ratio|2.34||||0.0026|2-Sided|95.0|1.35|4.07|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688298|NCT01138124|3105542|Superiority or Other||Unadjusted Odds Ratio|2.44||||0.0013|2-Sided|95.0|1.42|4.22|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688299|NCT01138124|3105542|Superiority or Other||Adjusted Odds Ratio|2.05||||0.1495|2-Sided|95.0|0.77|5.46|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688300|NCT01138124|3105542|Superiority or Other||Unadjusted Odds Ratio|2.03||||0.1488|2-Sided|95.0|0.78|5.34|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688301|NCT01138124|3105542|Superiority or Other||Adjusted Odds Ratio|1.75||||0.1313|2-Sided|95.0|0.85|3.63|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688302|NCT01138124|3105542|Superiority or Other||Unadjusted Odds Ratio|1.89||||0.0841|2-Sided|95.0|0.92|3.88|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688303|NCT01138124|3105543|Superiority or Other||Adjusted Odds Ratio|1.63||||0.3782|2-Sided|95.0|0.55|4.84|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688304|NCT01138124|3105543|Superiority or Other||Unadjusted Odds Ratio|1.7||||0.3336|2-Sided|95.0|0.58|4.96|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688305|NCT01138124|3105543|Superiority or Other||Adjusted Odds Ratio|1.1||||0.811|2-Sided|95.0|0.5|2.45|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688306|NCT01138124|3105543|Superiority or Other||Unadjusted Odds Ratio|1.19||||0.66|2-Sided|95.0|0.54|2.63|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688307|NCT01138124|3105543|Superiority or Other||Adjusted Odds Ratio|0.99||||0.9875|2-Sided|95.0|0.3|3.29|||Wilcoxon (Mann-Whitney)||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688308|NCT01138124|3105543|Superiority or Other||Unadjusted Odds Ratio|0.95||||0.9294|2-Sided|95.0|0.29|3.12|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688309|NCT01138124|3105543|Superiority or Other||Adjusted Odds Ratio|1.33||||0.4073|2-Sided|95.0|0.68|2.63|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688310|NCT01138124|3105543|Superiority or Other||Unadjusted Odds Ratio|1.35||||0.3762|2-Sided|95.0|0.69|2.65|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688311|NCT01138124|3105543|Superiority or Other||Adjusted Odds Ratio|2.4||||0.0603|2-Sided|95.0|0.96|5.98|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688626|NCT01131260|3106490|Superiority or Other||Risk Ratio (RR)|1.31||||0.2|2-Sided|95.0|0.87|1.98|||Chi-squared|||Analysis on primary composite outcome as a whole.|
1688313|NCT01138124|3105543|Superiority or Other||Adjusted Odds Ratio|2.9||||0.0005|2-Sided|95.0|1.59|5.28|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688314|NCT01138124|3105543|Superiority or Other||Unadjusted Odds Ratio|3.24|||<|0.0001|2-Sided|95.0|1.79|5.85|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688315|NCT01138124|3105544|Superiority or Other||Adjusted Odds Ratio|1.3||||0.6722|2-Sided|95.0|0.38|4.47|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688316|NCT01138124|3105544|Superiority or Other||Unadjusted Odds Ratio|1.32||||0.6528|2-Sided|95.0|0.39|4.47|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688317|NCT01138124|3105544|Superiority or Other||Adjusted Odds Ratio|0.83||||0.6999|2-Sided|95.0|0.33|2.11|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688318|NCT01138124|3105544|Superiority or Other||Unadjusted Odds Ratio|0.87||||0.7744|2-Sided|95.0|0.35|2.19|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688319|NCT01138124|3105544|Superiority or Other||Adjusted Odds Ratio|1.39||||0.5458|2-Sided|95.0|0.48|4.02|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688320|NCT01138124|3105544|Superiority or Other||Unadjusted Odds Ratio|1.4||||0.5308|2-Sided|95.0|0.49|4.01|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688321|NCT01138124|3105544|Superiority or Other||Adjusted Odds Ratio|1.77||||0.0896|2-Sided|95.0|0.92|3.43|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688322|NCT01138124|3105544|Superiority or Other||Unadjusted Odds Ratio|1.89||||0.0563|2-Sided|95.0|0.98|3.63|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688323|NCT01138124|3105544|Superiority or Other||Adjusted Odds Ratio|2.14||||0.0996|2-Sided|95.0|0.87|5.28|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688324|NCT01138124|3105544|Superiority or Other||Unadjusted Odds Ratio|2.18||||0.0856|2-Sided|95.0|0.9|5.32|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688325|NCT01138124|3105544|Superiority or Other||Adjusted Odds Ratio|2.34||||0.0034|2-Sided|95.0|1.32|4.14|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688326|NCT01138124|3105544|Superiority or Other||Unadjusted Odds Ratio|2.53||||0.0012|2-Sided|95.0|1.44|4.44|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”||
1688327|NCT01138124|3105545|Superiority or Other||Adjusted Odds Ratio|1.63||||0.1123|2-Sided|95.0|0.89|2.97|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688328|NCT01138124|3105545|Superiority or Other||Unadjusted Odds Ratio|1.65||||0.097|2-Sided|95.0|0.91|2.99|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”.||
1688329|NCT01138124|3105545|Superiority or Other||Adjusted Odds Ratio|1.68||||0.0095|2-Sided|95.0|1.13|2.49|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, hypertension, diuretic use, diabetes, neuropathic pain, and epilepsy.||
1688330|NCT01138124|3105545|Superiority or Other||Unadjusted Odds Ratio|1.79||||0.0031|2-Sided|95.0|1.22|2.63|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”.||
1688331|NCT01138124|3105546|Superiority or Other||Adjusted Odds Ratio|0.87||||0.7671|2-Sided|95.0|0.36|2.12|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688332|NCT01138124|3105546|Superiority or Other||Unadjusted Odds Ratio|1.01||||0.9858|2-Sided|95.0|0.42|2.41|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688333|NCT01138124|3105546|Superiority or Other||Adjusted Odds Ratio|1.15||||0.6365|2-Sided|95.0|0.64|2.08|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688334|NCT01138124|3105546|Superiority or Other||Unadjusted Odds Ratio|1.34||||0.3275|2-Sided|95.0|0.75|2.39|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688335|NCT01138124|3105546|Superiority or Other||Adjusted Odds Ratio|1.21||||0.6502|2-Sided|95.0|0.54|2.72|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688336|NCT01138124|3105546|Superiority or Other||Unadjusted Odds Ratio|1.42||||0.3928|2-Sided|95.0|0.64|3.16|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688337|NCT01138124|3105546|Superiority or Other||Adjusted Odds Ratio|1.64||||0.0947|2-Sided|95.0|0.92|2.95|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688683|NCT01130532|3106616|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1688338|NCT01138124|3105546|Superiority or Other||Unadjusted Odds Ratio|1.87||||0.0337|2-Sided|95.0|1.05|3.32|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688339|NCT01138124|3105546|Superiority or Other||Adjusted Odds Ratio|1.95||||0.0522|2-Sided|95.0|0.99|3.81|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688340|NCT01138124|3105546|Superiority or Other||Unadjusted Odds Ratio|2.19||||0.0212|2-Sided|95.0|1.12|4.25|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688341|NCT01138124|3105546|Superiority or Other||Adjusted Odds Ratio|2.65|||<|0.0001|2-Sided|95.0|1.71|4.11|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688342|NCT01138124|3105546|Superiority or Other||Unadjusted Odds Ratio|2.9|||<|0.0001|2-Sided|95.0|1.88|4.47|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688343|NCT01138124|3105547|Superiority or Other||Adjusted Odds Ratio|0.94||||0.8772|2-Sided|95.0|0.41|2.15|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688344|NCT01138124|3105547|Superiority or Other||Unadjusted Odds Ratio|1.11||||0.796|2-Sided|95.0|0.49|2.51|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688345|NCT01138124|3105547|Superiority or Other||Adjusted Odds Ratio|1.15||||0.6388|2-Sided|95.0|0.64|2.07|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688346|NCT01138124|3105547|Superiority or Other||Unadjusted Odds Ratio|1.34||||0.3245|2-Sided|95.0|0.75|2.39|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688347|NCT01138124|3105547|Superiority or Other||Adjusted Odds Ratio|0.72||||0.5274|2-Sided|95.0|0.26|2.01|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688348|NCT01138124|3105547|Superiority or Other||Unadjusted Odds Ratio|0.82||||0.699|2-Sided|95.0|0.29|2.28|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688349|NCT01138124|3105547|Superiority or Other||Adjusted Odds Ratio|1.5||||0.1762|2-Sided|95.0|0.83|2.69|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688350|NCT01138124|3105547|Superiority or Other||Unadjusted Odds Ratio|1.68||||0.0777|2-Sided|95.0|0.94|2.99|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688351|NCT01138124|3105547|Superiority or Other||Adjusted Odds Ratio|2.45||||0.0053|2-Sided|95.0|1.31|4.62|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688352|NCT01138124|3105547|Superiority or Other||Unadjusted Odds Ratio|2.75||||0.0015|2-Sided|95.0|1.47|5.13|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688353|NCT01138124|3105547|Superiority or Other||Adjusted Odds Ratio|2.88|||<|0.0001|2-Sided|95.0|1.85|4.46|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688354|NCT01138124|3105547|Superiority or Other||Unadjusted Odds Ratio|3.15|||<|0.0001|2-Sided|95.0|2.04|4.86|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688355|NCT01138124|3105548|Superiority or Other||Adjusted Odds Ratio|1.11||||0.8042|2-Sided|95.0|0.48|2.57|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688356|NCT01138124|3105548|Superiority or Other||Unadjusted Odds Ratio|1.31||||0.5205|2-Sided|95.0|0.58|2.97|||Conditional Logistic Regression||Comparison: “Tertile 3 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688357|NCT01138124|3105548|Superiority or Other||Adjusted Odds Ratio|1.17||||0.6062|2-Sided|95.0|0.65|2.11|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688358|NCT01138124|3105548|Superiority or Other||Unadjusted Odds Ratio|1.35||||0.3071|2-Sided|95.0|0.76|2.42|||Conditional Logistic Regression||Comparison: “Tertile 3 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688359|NCT01138124|3105548|Superiority or Other||Adjusted Odds Ratio|0.48||||0.2234|2-Sided|95.0|0.15|1.57|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688360|NCT01138124|3105548|Superiority or Other||Unadjusted Odds Ratio|0.55||||0.316|2-Sided|95.0|0.17|1.78|||Conditional Logistic Regression||Comparison: “Tertile 2 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688361|NCT01138124|3105548|Superiority or Other||Adjusted Odds Ratio|1.65||||0.1232|2-Sided|95.0|0.87|3.11|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688362|NCT01138124|3105548|Superiority or Other||Unadjusted Odds Ratio|1.8||||0.0645|2-Sided|95.0|0.97|3.36|||Conditional Logistic Regression||Comparison: “Tertile 2 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688363|NCT01138124|3105548|Superiority or Other||Adjusted Odds Ratio|2.44||||0.0042|2-Sided|95.0|1.32|4.49|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688364|NCT01138124|3105548|Superiority or Other||Unadjusted Odds Ratio|2.75||||0.001|2-Sided|95.0|1.51|5.03|||Conditional Logistic Regression||Comparison: “Tertile 1 (with 2 year lag)” and “Never (with 2 year lag)”.||
1688365|NCT01138124|3105548|Superiority or Other||Adjusted Odds Ratio|2.53|||<|0.0001|2-Sided|95.0|1.66|3.85|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy||
1688366|NCT01138124|3105548|Superiority or Other||Unadjusted Odds Ratio|2.82|||<|0.0001|2-Sided|95.0|1.86|4.28|||Conditional Logistic Regression||Comparison: “Tertile 1 (without 2 year lag)” and “Never (without 2 year lag)”.||
1688367|NCT01138124|3105549|Superiority or Other||Adjusted Odds Ratio|1.33||||0.2183|2-Sided|95.0|0.85|2.08|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688368|NCT01138124|3105549|Superiority or Other||Unadjusted Odds Ratio|1.52||||0.0627|2-Sided|95.0|0.98|2.36|||Conditional Logistic Regression||Comparison: “Ever (with 2 year lag)” and “Never (with 2 year lag)”.||
1688369|NCT01138124|3105549|Superiority or Other||Adjusted Odds Ratio|1.82||||0.0001|2-Sided|95.0|1.34|2.46|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”. Adjusted for smoking, BMI, diabetes, chronic pancreatitis, neuropathic pain, epilepsy.||
1688370|NCT01138124|3105549|Superiority or Other||Unadjusted Odds Ratio|2.04|||<|0.0001|2-Sided|95.0|1.51|2.75|||Conditional Logistic Regression||Comparison: “Ever (without 2 year lag)” and “Never (without 2 year lag)”.||
1688371|NCT01138111|3105553|Superiority or Other|||||||0.0008|||||||Wilcoxon (Mann-Whitney)|||The 24 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.|
1688372|NCT01138111|3105553|Superiority or Other|||||||0.0011|||||||Wilcoxon (Mann-Whitney)|||The 12 month neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.|
1688373|NCT01138111|3105553|Superiority or Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|||The baseline neocortical SUVR in those subjects who progressed to AD over the 2 year follow-up was compared to the neocortical SUVR of those that did not progress by a Wilcoxon-Mann-Whitney test.|
1688374|NCT01138007|3105585|Superiority or Other||Mean Difference (Final Values)|1.0|Standard Error of the Mean|1.0||||95.0|||||||In the analysis plan, the second comparison of interest was not to be performed if the first comparison failed to show statistical significance.||
1688375|NCT01138007|3105585|Superiority or Other||Least Squared Mean Difference|-0.5||||0.853|2-Sided|95.0|-2.7|1.7||The p-value was estimated based on the ANCOVA model including Baseline MADRS score and region as covariates. The multiplicity was adjusted by Dunnett’s step-down procedure.|ANCOVA||The confidence interval was estimated based on the ANCOVA model including Baseline MADRS score and region as covariates.||
1688376|NCT01137890|3105586|Superiority||F-value for the main effect of Zon x Coc|0.93||||0.46|2-Sided||||||ANOVA||F-value for main effect of Zonisamide x Cocaine interaction on drug value (i.e., street value) measurement||
1688377|NCT01137890|3105586|Superiority||F-value for main effect of Zon dose|0.77||||0.48|2-Sided||||||ANOVA||F-value for main effect of Zonisamide dose||
1688378|NCT01137890|3105586|Superiority||F-value for main effect of Coc dose|21.1|||<|0.01|2-Sided|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose||
1688379|NCT01137890|3105587|Superiority|Group*Day interaction|t value for Group x Day interaction|-1.63||||0.1|2-Sided||||||t-test, 2 sided||||
1688380|NCT01137890|3105587|Superiority|Day (Day 1-39)|t-value for main effect of Day|-3.2||||0.0015|2-Sided||||||t-test, 2 sided||||
1688381|NCT01137890|3105587|Superiority||t-value for main effect of Group|1.51||||0.16|2-Sided|||||Group (Zonisamide vs Placebo)|t-test, 2 sided||||
1688382|NCT01137890|3105588|Superiority||F-value for main effect of Coc x Zon|0.24||||0.92|2-Sided||||||ANOVA||F-value for main effect of Cocaine dose x Zonisamide dose interaction on Behavioral Choice measure||
1688383|NCT01137890|3105588|Superiority||F-value for main effect of Zon dose|0.07||||0.93|2-Sided||||||ANOVA||F-value for main effect of Zonisamide dose on Behavioral Choice measure||
1688384|NCT01137890|3105588|Superiority||F-value for main effect of Coc dose|9.91|||<|0.01|2-Sided|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose on Behavioral Choice measure||
1688385|NCT01137890|3105589|Superiority||F-value for main effect of Coc x Zon|0.66||||0.63|2-Sided||||||ANOVA||F-value for main effect of Cocaine x Zonisamide interaction on VAQ scores||
1688386|NCT01137890|3105589|Superiority||F-value for main effect of Zon dose|0.34||||0.72|2-Sided||||||ANOVA||F-value for main effect of Zonisamide dose on VAQ score||
1688387|NCT01137890|3105589|Superiority||F-value for main effect of Coc dose|24.9|||<|0.01|2-Sided|||||p-value was calculated as less than 0.01. Note: this is not an attempt to indicate a threshold|ANOVA||F-value for main effect of Cocaine dose on VAQ score||
1688388|NCT01137812|3105590|Superiority or Other||Least-Squares Mean Difference|7.0|Standard Error of the Mean|1.2|<|0.001|2-Sided|95.0|4.6|9.3|||ANCOVA||||
1688389|NCT01137812|3105591|Superiority or Other||Least-Squares Mean Difference|-2.3|Standard Error of the Mean|3.9||0.554|2-Sided|95.0|-9.8|5.3|||ANCOVA||||
1688390|NCT01137812|3105592|Superiority or Other||Least-Squares Mean Difference|-5.91|Standard Error of the Mean|0.883|<|0.001|2-Sided|95.0|-7.642|-4.175|||ANCOVA||||
1688391|NCT01137812|3105593|Superiority or Other||Least-Squares Mean Difference|-2.8|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-3.3|-2.2|||ANCOVA||||
1688392|NCT01137812|3105594|Superiority or Other||Least-Squares Mean Difference|-24.1|||<|0.001|2-Sided|95.0|-29.89|-18.24|||ANCOVA||||
1688393|NCT01137812|3105595|Superiority or Other||Odds Ratio (OR)|1.8|||||2-Sided|95.0|1.3|2.48|||||||
1688412|NCT01136733|3105792|Superiority or Other||Rate ratio|4.5|||=|0.0067|2-Sided|95.0|1.4|14.7||Analysis performed after database lock. P-value was based on the 2-sided Fisher’s exact P-value.|Fisher Exact||||
1688684|NCT01130272|3106630|Superiority or Other (legacy)||Odds Ratio (OR)|1.395||||0.326|2-Sided|95.0|0.717|2.716|||ANCOVA||||
1688394|NCT01137812|3105596|Non-Inferiority or Equivalence|Power calculation: assuming a difference between canagliflozin and sitagliptin of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.025, it was estimated that 234 patients per group would provide approximately 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with sitagliptin.|Least-Squares Mean Difference|-0.37|Standard Error of the Mean|0.064|<|0.05|2-Sided|95.0|-0.5|-0.25|||ANCOVA|||If the hypothesis of non-inferiority of canagliflozin to sitagliptin at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference [canagliflozin minus sitagliptin] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to sitagliptin would be concluded.|
1688395|NCT01137773|3105598|Superiority|||||||0.7|||||||t-test, 2 sided||||
1688396|NCT01137773|3105599|Superiority|||||||0.49|||||||t-test, 2 sided||||
1688397|NCT01137682|3105614|Superiority||Odds Ratio (OR)|23.03|||<|0.0001|2-Sided|95.0|4.72||infinity||Regression, Logistic|An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.|||
1688398|NCT01137682|3105614|Superiority||Odds Ratio (OR)|16.63|||<|0.0006|2-Sided|95.0|3.32||infinity||Regression, Logistic|An exact logistic regression model that adjusts for the randomization stratification factors was used to test the null hypothesis.|||
1688399|NCT01137474|3105634|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.0717|||2-Sided|95.0|-0.46|-0.18||||||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction.|
1688400|NCT01137474|3105635|Superiority or Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.6866|||2-Sided|95.0|-1.96|0.73||||||Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.|
1688401|NCT01137474|3105636|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.5811||0.0843|2-Sided|95.0|-2.15|0.14||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis.|
1688402|NCT01137474|3105637|Superiority or Other||Mean Difference (Final Values)|-2.89|Standard Error of the Mean|1.0091||0.0043|2-Sided|95.0|-4.88|-0.91||Endpoint tested following a sequential testing procedure at 2-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|ANCOVA|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 LOCF was calculated using an ANCOVA model with treatment group as an effect and baseline value and randomization strata as covariate. Data after rescue are excluded from blood pressure analyses.|
1688403|NCT01137474|3105638|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.0673|<|0.0001|2-Sided|95.0|-0.59|-0.33||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in the double-blind treatment period were included in the longitudinal repeated measures model||Change from baseline to week 12 was calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. With 253 subjects per group, there is >98% power to detect a difference of 0.4% at a=0.05, assuming a common SD of 1.1%.|
1688404|NCT01137474|3105639|Superiority or Other||Mean Difference (Final Values)|-3.05|Standard Error of the Mean|0.9251||0.001|2-Sided|95.0|-4.87|-1.24||Endpoint tested following a sequential testing procedure at two-sided alpha=0.05 to control the family-wise Type I error rate related to primary and secondary efficacy endpoints. Test performed since previous tests were significant.|Longitudinal repeated measures analysis|Only Week 12 data are presented; data from all weeks in double-blind period were included in the longitudinal repeated measures model.||Change from baseline to week 12 calculated using a longitudinal repeated measures analysis using direct likelihood with fixed categorical effects of treatment, week, treatment-by-week interaction, and randomization strata and continuous fixed covariates of baseline value and baseline value by week interaction. Data after rescue were not included in the analysis. With 253 patients per group, there is >80% power to detect a difference of 3.5 mm Hg at alpha=0.05, assuming a common SD of 14 mm Hg.|
1688405|NCT01136785|3105745|Superiority or Other|||||||0.036|||||||two-sided paired t-test|||comparing pre and post levels in the active CPAP group|
1688406|NCT01136785|3105746|Superiority or Other|||||||0.308|||||||two-sided paired t-test|||comparing pre and post levels in the active CPAP group|
1688407|NCT01136785|3105747|Superiority or Other|||||||0.754|||||||two-sided paired t-test|||Plasma cortisol pre and post 1-week of active CPAP|
1688408|NCT01136785|3105748|Superiority or Other|||||||0.071|||||||t-test, 2 sided||||
1688409|NCT01136785|3105749|Superiority or Other|||||||0.011|||||||2-sided Paired t-test|||comparing pre and post Interstitial Glucose levels in the active CPAP group|
1688410|NCT01136785|3105750|Superiority or Other|||||||0.01|||||||t-test, 2 sided|||two-sided t test for the change from baseline between the treated and untreated groups.|
1688411|NCT01136733|3105792|Superiority or Other||Rate ratio|1.6|||=|0|2-Sided|95.0|0.9|2.8||Analysis performed after database lock. P-value was based on the 2-sided Fisher’s exact P-value.|Fisher Exact||||
1688685|NCT01130272|3106630|Superiority or Other (legacy)||Odds Ratio (OR)|2.014||||0.03|2-Sided|95.0|1.069|3.795|||ANCOVA||||
1688413|NCT01136733|3105792|Superiority or Other||Rate ratio|7.2|||<|0.0001|2-Sided|95.0|2.3|22.5||Analysis performed after database lock. P-value was based on the 2-sided Fisher’s exact P-value.|Fisher Exact||Rate ratio was based on the normal approximation.||
1688414|NCT01136733|3105793|Superiority or Other||Hazard Ratio (HR)|0.751|||=|0|2-Sided|95.0|0.433|1.301|||Log Rank||||
1688415|NCT01136733|3105793|Superiority or Other||Hazard Ratio (HR)|0.684|||=|0|2-Sided|95.0|0.411|1.138|||Log Rank||||
1688416|NCT01136733|3105793|Superiority or Other||Hazard Ratio (HR)|0.514|||=|0|2-Sided|95.0|0.299|0.884|||Log Rank||Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.|Planned analyses were performed to test null hypothesis of treatment difference in OS at a nominal significance level of 0.05 (2-sided) using the stratified log-rank test using stratification factors.|
1688417|NCT01136733|3105794|Superiority or Other||Hazard Ratio (HR)|0.66||||0.1209|2-Sided|95.0|0.39|1.1|||Log Rank||||
1688418|NCT01136733|3105794|Superiority or Other||Hazard Ratio (HR)|0.61||||0.0479|2-Sided|95.0|0.38|0.98|||Log Rank||||
1688419|NCT01136733|3105794|Superiority or Other||Hazard Ratio (HR)|0.4|||=|0|2-Sided|95.0|0.24|0.68|||Log Rank||Hazard ratio between treatment groups and corresponding 95% CI was estimated using the stratified Cox regression model (stratified by hemoglobin and corrected serum calcium) with treatment as a factor.|Null hypothesis of no difference in PFS was analyzed using the stratified log-rank test with hemoglobin (less than or equal to 13 g/dL vs greater than 13 g/dL for males; and less than or equal to 11.5 g/dL vs greater than 11.5 g/dL for females) and corrected serum calcium (greater than or equal to 10 mg/dL vs less than 10 mg/dL) as stratification factors. Each null hypothesis was tested at a nominal alpha=0.05.|
1688420|NCT01136655|3105797|Superiority or Other||LS mean difference|1.12||||0.4512|2-Sided|95.0|0.827|1.528|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) [log(response + 1) if response is 0].||Factors in the ANOVA model included: patient, period and treatment.|
1688421|NCT01136655|3105797|Superiority or Other||LS mean difference|0.56||||0.0002|2-Sided|95.0|0.409|0.755|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) [log(response + 1) if response is 0].||Factors in the ANOVA model included: patient, period and treatment.|
1688422|NCT01136655|3105797|Superiority or Other||LS mean difference|0.49|||<|0.0001|2-Sided|95.0|0.371|0.659|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) [log(response + 1) if response is 0].||Factors in the ANOVA model included: patient, period and treatment.|
1688423|NCT01136655|3105797|Superiority or Other||LS mean difference|0.29|||<|0.0001|2-Sided|95.0|0.214|0.396|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) [log(response + 1) if response is 0].||Factors in the ANOVA model included: patient, period and treatment.|
1688424|NCT01136655|3105797|Superiority or Other||LS mean difference|0.26|||<|0.0001|2-Sided|95.0|0.194|0.347|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) [log(response + 1) if response is 0].||Factors in the ANOVA model included: patient, period and treatment.|
1688425|NCT01136655|3105797|Superiority or Other||LS mean difference|0.52|||<|0.0001|2-Sided|95.0|0.393|0.7|||ANOVA|A shift log transformation was performed on the response variable in the ANOVA model, using log(response) [log(response + 1) if response is 0].||Factors in the ANOVA model included: patient, period and treatment.|
1688426|NCT01136655|3105798|Superiority or Other||LS mean difference|-0.008|Standard Error of the Mean|0.017||0.6276|2-Sided|95.0|-0.042|0.025|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688427|NCT01136655|3105798|Superiority or Other||LS mean difference|-0.003|Standard Error of the Mean|0.0172||0.8582|2-Sided|95.0|-0.037|0.031|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688428|NCT01136655|3105798|Superiority or Other||LS mean difference|-0.058|Standard Error of the Mean|0.0172||0.0008|2-Sided|95.0|-0.092|-0.024|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688429|NCT01136655|3105798|Superiority or Other||LS mean difference|-0.115|Standard Error of the Mean|0.0171|<|0.0001|2-Sided|95.0|-0.149|-0.081|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688430|NCT01136655|3105798|Superiority or Other||LS mean difference|-0.055|Standard Error of the Mean|0.0168|<|0.0011|2-Sided|95.0|-0.089|-0.022|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688431|NCT01136655|3105798|Superiority or Other||LS mean difference|-0.05|Standard Error of the Mean|0.017|<|0.0035|2-Sided|95.0|-0.084|-0.017|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688432|NCT01136655|3105798|Superiority or Other||LS mean difference|0.005|Standard Error of the Mean|0.0169|<|0.7589|2-Sided|95.0|-0.028|0.039|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688433|NCT01136655|3105798|Superiority or Other||LS mean difference|0.057|Standard Error of the Mean|0.0172|<|0.0011|2-Sided|95.0|0.023|0.09|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688434|NCT01136655|3105798|Superiority or Other||LS mean difference|0.112|Standard Error of the Mean|0.0171|<|0.0001|2-Sided|95.0|0.078|0.146|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688435|NCT01136655|3105798|Superiority or Other||LS mean difference|0.107|Standard Error of the Mean|0.017|<|0.0001|2-Sided|95.0|0.073|0.14|||ANCOVA|||Factors in the Analysis of Covariance model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688436|NCT01136655|3105799|Superiority or Other||LS mean difference|0.022|Standard Error of the Mean|0.025||0.38|2-Sided|95.0|-0.027|0.071|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688437|NCT01136655|3105799|Superiority or Other||LS mean difference|-0.017|Standard Error of the Mean|0.0252||0.4957|2-Sided|95.0|-0.067|0.033|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688438|NCT01136655|3105799|Superiority or Other||LS mean difference|-0.068|Standard Error of the Mean|0.0254||0.0077|2-Sided|95.0|-0.118|-0.018|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688439|NCT01136655|3105799|Superiority or Other||LS mean difference|-0.083|Standard Error of the Mean|0.0252||0.0011|2-Sided|95.0|-0.133|-0.034|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688440|NCT01136655|3105799|Superiority or Other||LS mean difference|-0.051|Standard Error of the Mean|0.0247||0.04|2-Sided|95.0|-0.1|-0.002|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688441|NCT01136655|3105799|Superiority or Other||LS mean difference|-0.09|Standard Error of the Mean|0.025||0.0004|2-Sided|95.0|-0.14|-0.041|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688442|NCT01136655|3105799|Superiority or Other||LS mean difference|-0.039|Standard Error of the Mean|0.0249||0.1163|2-Sided|95.0|-0.088|0.01|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688443|NCT01136655|3105799|Superiority or Other||LS mean difference|0.015|Standard Error of the Mean|0.0252||0.5509|2-Sided|95.0|-0.035|0.065|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688444|NCT01136655|3105799|Superiority or Other||LS mean difference|0.066|Standard Error of the Mean|0.0252||0.0092|2-Sided|95.0|0.017|0.116|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688445|NCT01136655|3105799|Superiority or Other||LS mean difference|0.105|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.056|0.155|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688446|NCT01136655|3105800|Superiority or Other||LS mean difference|0.0|Standard Error of the Mean|0.014||0.9863|2-Sided|95.0|-0.027|0.028|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688447|NCT01136655|3105800|Superiority or Other||LS mean difference|-0.009|Standard Error of the Mean|0.0141||0.5394|2-Sided|95.0|-0.036|0.019|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688448|NCT01136655|3105800|Superiority or Other||LS mean difference|-0.056|Standard Error of the Mean|0.0141||0.0001|2-Sided|95.0|-0.084|-0.028|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688449|NCT01136655|3105800|Superiority or Other||LS mean difference|-0.114|Standard Error of the Mean|0.0141|<|0.0001|2-Sided|95.0|-0.142|-0.086|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688450|NCT01136655|3105800|Superiority or Other||LS mean difference|-0.048|Standard Error of the Mean|0.0138|<|0.0007|2-Sided|95.0|-0.075|-0.02|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688451|NCT01136655|3105800|Superiority or Other||LS mean difference|-0.057|Standard Error of the Mean|0.0139|<|0.0001|2-Sided|95.0|-0.084|-0.029|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688452|NCT01136655|3105800|Superiority or Other||LS mean difference|-0.009|Standard Error of the Mean|0.0139|<|0.5223|2-Sided|95.0|-0.036|0.018|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688453|NCT01136655|3105800|Superiority or Other||LS mean difference|0.058|Standard Error of the Mean|0.0141|<|0.0001|2-Sided|95.0|0.03|0.085|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688454|NCT01136655|3105800|Superiority or Other||LS mean difference|0.105|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.078|0.133|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment.||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688455|NCT01136655|3105800|Superiority or Other||LS mean difference|0.114|Standard Error of the Mean|0.014|<|0.0001|2-Sided|95.0|0.087|0.142|||ANCOVA|LOCF was performed if missing data were post last non-missing post-baseline assessment||Factors in the ANCOVA model included: patient, visit, treatment, and the covariate pre-dose FEV1 from each visit.|
1688456|NCT01136382|3105820|Superiority or Other|||||||0.0004|||||||Log Rank||||
1688457|NCT01136382|3105821|Superiority or Other||LS mean difference|-0.2|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.3|-0.1|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.|
1688475|NCT01134783|3106027|Superiority or Other|||||||0.049||||||The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.|Regression, Logistic||||
1688458|NCT01136382|3105822|Superiority or Other||LS mean difference|-0.5|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-0.7|-0.2||Analysis for change in total reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.|
1688459|NCT01136382|3105822|Superiority or Other||LS mean difference|-0.3|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|-0.4|-0.1||Analysis for change in daytime reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.|
1688460|NCT01136382|3105823|Superiority or Other||LS mean difference|-3.9|Standard Error of the Mean|1.15||0.0007|2-Sided|95.0|-6.2|-1.7||Analysis for change in nighttime awakenings with reliever medication use from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.|
1688461|NCT01136382|3105823|Superiority or Other||LS mean difference|-4.7|Standard Error of the Mean|1.78||0.0095|2-Sided|95.0|-8.2|-1.1||Analysis for change in nighttime awakenings from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.|
1688462|NCT01136382|3105824|Superiority or Other||LS mean difference|-0.1|Standard Error of the Mean|0.06||0.0079|2-Sided|95.0|-0.26|-0.04|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.|
1688463|NCT01136382|3105825|Superiority or Other||LS mean difference|-0.3|Standard Error of the Mean|0.11||0.0015|2-Sided|95.0|-0.55|-0.13||Analysis for change in total asthma symptom score from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.|
1688464|NCT01136382|3105825|Superiority or Other||LS mean difference|-0.2|Standard Error of the Mean|0.06||0.0004|2-Sided|95.0|-0.31|-0.09||Analysis for change in daytime asthma symptom score from baseline to treatment period average.|ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.|
1688465|NCT01136382|3105826|Superiority or Other||LS mean difference|0.1|Standard Error of the Mean|0.044||0.0216|2-Sided|95.0|0.01|0.19|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.|
1688466|NCT01136382|3105827|Superiority or Other||LS mean difference|0.04|Standard Error of the Mean|0.02||0.0673|2-Sided|95.0|0.0|0.08|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.|
1688467|NCT01136382|3105828|Superiority or Other||LS mean difference|10.8|Standard Error of the Mean|3.0||0.0004|2-Sided|95.0|4.9|16.7|||ANCOVA|||Change from baseline to treatment period average was analyzed using an ANCOVA model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.|
1688468|NCT01136382|3105829|Superiority or Other||LS mean difference|0.06|Standard Error of the Mean|0.022||0.0047|2-Sided|95.0|0.02|0.11||To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.|ANCOVA|||Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.|
1688469|NCT01136382|3105830|Superiority or Other||LS mean difference|13.6|Standard Error of the Mean|3.1|<|0.0001|2-Sided|95.0|7.5|19.7||To address multiplicity, a step-down procedure was used. If the treatment difference for the primary variable, morning PEF, was statistically significant (p<0.05), then the key secondary variable, FEV1, was tested at the 0.05 level of significance.|ANCOVA|||Change from baseline to treatment period average was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, age group (<8 years and ≥8 years of age) and country with baseline as a covariate.|
1688470|NCT01136291|3105836|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|||The homogeneity between the groups was compared by the Student’s t test or the Mann-Whitney test for continuous variables and chi-square for categorical variables.A comparison between values before and after the study group session was performed by the Student’s t test. The effect of the exercise was evaluated by repeated measures ANOVA, where the effect of time and group were evaluated on pressure, weight, Body Mass Index (BMI)and World Health Organization Quality of Life Questionnarie domains.|
1688471|NCT01135420|3105935|Superiority or Other||Mean Difference (Final Values)|0.4|||<|0.05|2-Sided||||||ANCOVA||||
1688472|NCT01135134|3105987|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1688473|NCT01135134|3105988|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1688474|NCT01135017|3105995|Superiority or Other||Least Squares (LS) Mean difference|-59.13|Standard Error of the Mean|0.275||0.0015|2-Sided|95.0|-76.322|-29.457||No adjustment for multiplicity was made. The priori threshold for statistical significance was ≤0.05.|ANCOVA|ANCOVA model on log-transformed AF burden data with treatment arm as a fixed effect term and baseline log-transformed AF burden as a covariate|"Percent change in AF burden with dronedarone relative to placebo~LS Mean difference from the ANCOVA model on log-transformed AF burden data was exponentiated to convert back to percent change."|"The planned sample size of 286 participants was estimated to have 70% power to detect a reduction in mean AF burden of 30% relative to the placebo group.~Due to the smaller-than-planned sample size, the power to detect this difference was estimated to be only 44%, based on the original assumption. However, the power to detect larger treatment effects (>40% reduction) remained high and the posthoc power to detect a 60% reduction in AF burden was 99%."|
1688587|NCT01132118|3106437|Superiority or Other|||||||0.004||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.|
1688476|NCT01134783|3106028|Superiority or Other|||||||0.707||||||The analysis used hierarchical linear models having repeated measures of the outcome regressed on experimental condition, adjusted for baseline age, sex, race, and household education level as well as wave and college.|Regression, Logistic||||
1688477|NCT01134705|3106031|Superiority or Other||LS Mean Difference|-0.58||||0.001|2-Sided|95.0|-0.9|-0.2||A priori threshold for statistical significance is p<0.05|ANCOVA|ANCOVA with treatment, baseline and center in the model.|||
1688478|NCT01134705|3106032|Superiority or Other||LS Mean Difference|-0.78|||<|0.001|2-Sided|95.0|-1.1|-0.4||A priori threshold for statistical significance is p<0.05|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.|||
1688479|NCT01134705|3106033|Superiority or Other||LS Mean Difference|-0.84|||<|0.001|2-Sided|95.0|-1.2|-0.5||A priori threshold for statistical significance is p<0.05|Repeated measures Analysis of covariance|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.|||
1688480|NCT01134263|3106127|Equivalence|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|-0.017|||||2-Sided|95.0|-0.137|0.103||||||Dengue Virus Serotype 4|
1688481|NCT01134263|3106127|Equivalence|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|-0.076|||||2-Sided|95.0|-0.173|0.021||||||Dengue Virus Serotype 3|
1688482|NCT01134263|3106127|Equivalence|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|0.334|||||2-Sided|95.0|0.202|0.466||||||Dengue Virus Serotype 2|
1688483|NCT01134263|3106127|Equivalence|Equivalence between the pooled Phase III and Phase II was demonstrated if, for each serotype the lower limit of the 95%CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|0.091|||||2-Sided|95.0|-0.009|0.192||||||Dengue Virus Serotype 1|
1688484|NCT01134263|3106128|Equivalence|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|-0.085|||||2-Sided|95.0|-0.242|0.073||||||Dengue Virus Serotype 4: Phase III Lot 3 vs Lot 1|
1688485|NCT01134263|3106128|Equivalence|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|-0.06|||||2-Sided|95.0|-0.207|0.088||||||Dengue Virus Serotype 4: Phase III Lot 2 vs Lot 3|
1688486|NCT01134263|3106128|Equivalence|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|0.144|||||2-Sided|95.0|-0.006|0.295||||||Dengue Virus Serotype 4: Phase III Lot 1 vs Lot 2|
1688487|NCT01134263|3106128|Equivalence|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|-0.016|||||2-Sided|95.0|-0.144|0.113||||||Dengue Virus Serotype 3: Phase III Lot 3 vs Lot 1|
1688488|NCT01134263|3106128|Equivalence|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|-0.042|||||2-Sided|95.0|-0.167|0.082||||||Dengue Virus Serotype 3: Phase III Lot 2 vs Lot 3|
1688489|NCT01134263|3106128|Equivalence|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|0.058|||||2-Sided|95.0|-0.068|0.184||||||Dengue Virus Serotype 3: Phase III Lot 1 vs Lot 2|
1688490|NCT01134263|3106128|Equivalence|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|-0.054|||||2-Sided|95.0|-0.225|0.117||||||Dengue Virus Serotype 2: Phase III Lot 3 vs Lot 1|
1688491|NCT01134263|3106128|Equivalence|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|-0.12|||||2-Sided|95.0|-0.297|0.056||||||Dengue Virus Serotype 2: Phase III Lot 2 vs Lot 3|
1688492|NCT01134263|3106128|Equivalence|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|0.174|||||2-Sided|95.0|0.009|0.34||||||Dengue Virus Serotype 2: Phase III Lot 1 vs Lot 2|
1688493|NCT01134263|3106128|Equivalence|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|-0.08|||||2-Sided|95.0|-0.204|0.045||||||Dengue Virus Serotype 1: Phase III Lot 3 vs Lot 1|
1688494|NCT01134263|3106128|Equivalence|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|0.024|||||2-Sided|95.0|-0.102|0.151||||||Dengue Virus Serotype 1: Phase III Lot 2 vs Lot 3|
1688495|NCT01134263|3106128|Equivalence|Lot consistency for each pair of lots was demonstrated if, for each pair of lots and each serotype the lower limit of the 95% CI was > -0.301 and the upper limit was < 0.301.|Difference of Log10 GMT|0.055|||||2-Sided|95.0|-0.067|0.178||||||Dengue Virus Serotype 1: Phase III Lot 1 vs Lot 2|
1688496|NCT01134107|3106130|Superiority or Other|||||||0.894||||||P-value for Diastolic Blood Pressure (DBP) computed using crossover model. Response = treatment + sequence + period + baseline diastolic blood pressure.|Crossover Model||||
1688497|NCT01134107|3106130|Superiority or Other|||||||0.147||||||P-value for the Systolic Blood Pressure (SBP) computed using crossover model. Response = treatment + sequence + period + baseline systolic blood pressure.|Crossover Model||||
1688498|NCT01134107|3106131|Superiority or Other||||||<|0.001|||||||Crossover Model|P-value computed using crossover model. Response = treatment + sequence + period + baseline body weight|||
1688499|NCT01134107|3106132|Superiority or Other||||||<|0.001|||||||Negative Binomial Test|P-value computed using a negative binomial test including factors for treatment, period and sequence.|||
1688686|NCT01130272|3106630|Superiority or Other (legacy)||Odds Ratio (OR)|1.208||||0.583|2-Sided|95.0|0.615|2.373|||ANCOVA||||
1688500|NCT01134107|3106133|Superiority or Other|||||||1||||||The p-value is for the Documented Hypoglycemic Episodes category treatment arm comparison. The p-value for the All Reported Hypoglycemic Episodes category could not be generated using Gart's Test.|Gart's Test|Participants represented in both treatment groups, and with non-missing incidence value in each treatment period, were used for p-value calculation.|||
1688501|NCT01134107|3106134|Superiority or Other|||||||0.499||||||P-value for Premature Infusion Set Change computed using negative binomial test including factors for treatment, period and sequence.|negative binomial test||||
1688502|NCT01134107|3106134|Superiority or Other|||||||0.383||||||P-value for Premature Reservoir Change computed using negative binomial test including factors for treatment, period and sequence.|negative binomial test||||
1688503|NCT01134107|3106135|Superiority or Other|||||||0.472||||||P-value for overall pump complications associated with a premature infusion set change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used.|Gart's Test||||
1688504|NCT01134107|3106135|Superiority or Other|||||||1||||||P-value for overall pump complications associated with a premature reservoir change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used.|Gart's Test||||
1688505|NCT01134107|3106136|Superiority or Other|||||||0.059|||||||negative binomial test|P-value computed using a negative binomial test including factors for treatment, period and sequence.|||
1688506|NCT01134107|3106138|Superiority or Other|||||||0.79||||||P-value for Bolus Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Bolus Dose.|Crossover Model||||
1688507|NCT01134107|3106138|Superiority or Other|||||||0.506||||||P-value for Basal Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Basal Dose.|Crossover Model||||
1688508|NCT01134107|3106138|Superiority or Other|||||||0.595||||||P-value for Total Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Total Dose.|Crossover Model||||
1688509|NCT01134107|3106139|Superiority or Other||Odds Ratio (OR)|0.36|||||2-Sided|95.0|0.2|0.63|||||Odds Ratio of HbA1c <7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.||
1688510|NCT01134107|3106139|Superiority or Other||Odds Ratio (OR)|0.8|||||2-Sided|95.0|0.39|1.63|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.||
1688511|NCT01134107|3106140|Superiority or Other||Least Squares Mean Difference|0.16|||||2-Sided|95.0|0.08|0.24|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c||
1688512|NCT01134107|3106141|Superiority or Other||Least Squares Mean Difference|0.23|||||2-Sided|95.0|-0.15|0.6|||||Daily Bolus Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose||
1688513|NCT01134107|3106141|Superiority or Other||Least Squares Mean Difference|0.02|||||2-Sided|95.0|-0.26|0.31|||||Daily Basal Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose||
1688514|NCT01134107|3106141|Superiority or Other||Least Squares Mean Difference|0.38|||||2-Sided|95.0|-0.13|0.88|||||Daily Total Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose||
1688515|NCT01134107|3106142|Non-Inferiority or Equivalence|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.42|||||2-Sided|95.0|0.25|0.58|||||Least Squares Mean Difference = Insulin Lispro 6 Day (Day 6) minus Insulin Lispro 6 Day (Day 2); adjusted for DayGroup + Period + Baseline HbA1c||
1688516|NCT01134107|3106142|Non-Inferiority or Equivalence|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.18|||||2-Sided|95.0|-0.1|0.47|||||Least Squares Mean Difference = Insulin Lispro 6 Day (Day 1-6) minus Insulin Aspart 6 Day (Day 1-6); adjusted for Treatment + Sequence + Period + Baseline HbA1c||
1688517|NCT01134107|3106143|Non-Inferiority or Equivalence|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.36|||||2-Sided|95.0|0.06|0.66|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline HbA1c|This was the primary gated analysis.|
1688518|NCT01134055|3106162|Superiority or Other|||||||0.7673||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented|
1688519|NCT01134055|3106162|Superiority or Other|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented|
1688520|NCT01134055|3106162|Superiority or Other|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented|
1688521|NCT01134055|3106162|Superiority or Other|||||||0.97||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented|
1688522|NCT01134055|3106162|Superiority or Other|||||||0.2429||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Overall Injection Rate at 52 weeks is presented|
1688523|NCT01134055|3106162|Superiority or Other|||||||0.7418||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented|
1688524|NCT01134055|3106162|Superiority or Other|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented|
1688525|NCT01134055|3106162|Superiority or Other|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented|
1688526|NCT01134055|3106162|Superiority or Other|||||||0.8263||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented|
1688527|NCT01134055|3106162|Superiority or Other|||||||0.1974||||||Adjusted p-Value has been presented.|ANOVA|||Statistics for Injection Rate at 28 Weeks is presented|
1688528|NCT01134042|3106173|Superiority or Other||Median Difference (Final Values)|0.206||||0.003|2-Sided|95.0|0.073|0.339|||ANCOVA||||
1688529|NCT01134042|3106173|Superiority or Other||Mean Difference (Final Values)|0.136||||0.048|2-Sided|95.0|0.001|0.27|||ANCOVA||||
1688588|NCT01132118|3106437|Superiority or Other|||||||0.004||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.|
1688530|NCT01134042|3106174|Non-Inferiority or Equivalence|Non-inferiority is demonstrated if the lower limit of the confidence interval (CI: 0.025, 1-sided significance level) for the mean difference in change from Baseline in clinic visit trough FEV1 of FF 200 µg OD versus FP 500 µg BID was greater than -125 milliliters.|Median Difference (Final Values)|0.018|||||2-Sided|95.0|-0.066|0.102|||||||
1688531|NCT01134042|3106174|Superiority or Other||Median Difference (Final Values)|0.21|||<|0.001|2-Sided|95.0|0.127|0.294|||ANCOVA||||
1688532|NCT01134042|3106174|Superiority or Other||Median Difference (Final Values)|0.193|||<|0.001|2-Sided|95.0|0.108|0.277|||ANCOVA||||
1688533|NCT01133977|3106187|Superiority or Other||Hazard Ratio (HR)|0.4|||||2-Sided|95.0|0.23|0.75||||||The current study was not powered or designed to determine superiority of the '20 mg Lenvatinib + Dacarbazine (Phase 2)' arm compared with 'Dacarbazine (Phase 2) ' arm.|
1688534|NCT01133821|3106205|Superiority||||||>|0.05|||||||Regression, Linear|Adjusted for baseline scores|||
1688535|NCT01133821|3106206|Superiority||||||<|0.0001|||||||Mixed Models Analysis|||time effect for HRSD-17|
1688536|NCT01133704|3106210|Superiority or Other||Hazard Ratio (HR)|1.27||||0.331|2-Sided|95.0|0.78|2.07|||Log Rank||Obtained from a Cox proportional hazards model with treatment as the independent variable, and stratified by bisphosphonate use (placebo/sipuleucel-T).||
1688537|NCT01133704|3106211|Superiority or Other||Hazard Ratio (HR)|1.09||||0.719|2-Sided|95.0|0.69|1.7|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable, stratified by bisphosphonate use (placebo/sipuleucel-T)||
1688538|NCT01133678|3106212|Other|||||||0.19||||||A recommendation to stop the trial early was stipulated if the conditional power at the interim analysis (after 50 patients) was <10% using a stochastic curtailment approach.. This would occur if the interim test statistic is t < -0.287.|t-test, 2 sided|t-statistic = -1.330, exceeding threshold (<-0.287, conditional power<10%) for early termination.|||
1688539|NCT01133626|3106256|Non-Inferiority or Equivalence|Non-inferiority would be demonstrated if the lower limit of a two-sided 95% CI for the geometric mean ratio of BDP HFA 320 mcg/day to placebo was greater than 0.80.|geometric mean ratio|0.96|||||2-Sided|95.0|0.87|1.06|||||||
1688540|NCT01133418|3106263|Superiority or Other|||||||0.77|||||||General Linear Model||||
1688541|NCT01133418|3106264|Superiority or Other|||||||0.79|||||||General Linear Model||||
1688542|NCT01133418|3106265|Superiority or Other|||||||0.86|||||||General Linear Model||||
1688543|NCT01133418|3106266|Superiority or Other|||||||0.36||||||a priori threshold for statistical significance was .05|General Linear Model||||
1688544|NCT01133392|3106274|Superiority or Other||Ratio of geometric least square means|1.014|||||2-Sided|90.0|0.961|1.07|||||||
1688545|NCT01133392|3106275|Superiority or Other||Median Difference (Final Values)|0.1|||||2-Sided|90.0|-0.4|0.5|||||||
1688546|NCT01133392|3106276|Superiority or Other||Ratio of geometric least square means|1.005|||||2-Sided|90.0|0.958|1.054|||||||
1688547|NCT01133392|3106277|Superiority or Other||Ratio of geometric least square means|0.933|||||2-Sided|90.0|0.897|0.972|||||||
1688548|NCT01133392|3106278|Superiority or Other||Ratio of geometric least square means|0.99|||||2-Sided|90.0|0.948|1.034|||||||
1688549|NCT01133379|3106279|Superiority or Other||Mean Difference (Final Values)|-5.84|Standard Error of the Mean|3.687||0.115|2-Sided|95.0|-13.1|1.44||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688550|NCT01133379|3106279|Superiority or Other||Mean Difference (Final Values)|-4.41|Standard Error of the Mean|3.684||0.233|2-Sided|95.0|-11.7|2.86||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688551|NCT01133379|3106280|Superiority or Other||Mean Difference (Final Values)|-4.07|Standard Error of the Mean|3.526||0.25|2-Sided|95.0|-11.0|2.89||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688552|NCT01133379|3106280|Superiority or Other||Mean Difference (Final Values)|-2.32|Standard Error of the Mean|3.522||0.511|2-Sided|95.0|-9.27|4.64||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688553|NCT01133379|3106281|Superiority or Other||Mean Difference (Final Values)|-6.1|Standard Error of the Mean|2.997||0.043|2-Sided|95.0|-12.0|-0.18||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688554|NCT01133379|3106281|Superiority or Other||Mean Difference (Final Values)|-6.19|Standard Error of the Mean|2.994||0.04|2-Sided|95.0|-12.1|-0.27||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688555|NCT01133379|3106282|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|2.371||0.914|2-Sided|95.0|-4.94|4.42||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688589|NCT01132118|3106438|Superiority or Other|||||||0.902||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.|
1688556|NCT01133379|3106282|Superiority or Other||Mean Difference (Final Values)|0.97|Standard Error of the Mean|2.369||0.683|2-Sided|95.0|-3.71|5.65||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline global subjective VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688557|NCT01133379|3106283|Superiority or Other||Mean Difference (Final Values)|-0.33|Standard Error of the Mean|3.688||0.928|2-Sided|95.0|-7.61|6.95||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688558|NCT01133379|3106283|Superiority or Other||Mean Difference (Final Values)|-1.21|Standard Error of the Mean|3.69||0.743|2-Sided|95.0|-8.5|6.07||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688559|NCT01133379|3106284|Superiority or Other||Mean Difference (Final Values)|-1.29|Standard Error of the Mean|3.599||0.721|2-Sided|95.0|-8.39|5.82||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688560|NCT01133379|3106284|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|3.601||0.989|2-Sided|95.0|-7.16|7.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688561|NCT01133379|3106285|Superiority or Other||Mean Difference (Final Values)|-3.66|Standard Error of the Mean|3.235||0.26|2-Sided|95.0|-10.0|2.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688562|NCT01133379|3106285|Superiority or Other||Mean Difference (Final Values)|-2.61|Standard Error of the Mean|3.235||0.421|2-Sided|95.0|-9.0|3.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688563|NCT01133379|3106286|Superiority or Other||Mean Difference (Final Values)|-3.88|Standard Error of the Mean|2.679||0.149|2-Sided|95.0|-9.17|1.41||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688564|NCT01133379|3106286|Superiority or Other||Mean Difference (Final Values)|-2.46|Standard Error of the Mean|2.678||0.36|2-Sided|95.0|-7.75|2.83||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean cold air VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688565|NCT01133379|3106287|Superiority or Other||Mean Difference (Final Values)|1.36|Standard Error of the Mean|3.61||0.708|2-Sided|95.0|-5.77|8.48||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688566|NCT01133379|3106287|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|3.61||0.847|2-Sided|95.0|-7.83|6.43||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688567|NCT01133379|3106288|Superiority or Other||Mean Difference (Final Values)|1.91|Standard Error of the Mean|3.477||0.583|2-Sided|95.0|-4.95|8.78||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688568|NCT01133379|3106288|Superiority or Other||Mean Difference (Final Values)|-1.81|Standard Error of the Mean|3.478||0.604|2-Sided|95.0|-8.68|5.06||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688569|NCT01133379|3106289|Superiority or Other||Mean Difference (Final Values)|-2.9|Standard Error of the Mean|2.854||0.311|2-Sided|95.0|-8.54|2.73||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups|
1688570|NCT01133379|3106289|Superiority or Other||Mean Difference (Final Values)|-1.98|Standard Error of the Mean|2.856||0.488|2-Sided|95.0|-7.62|3.66||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688571|NCT01133379|3106290|Superiority or Other||Mean Difference (Final Values)|-0.82|Standard Error of the Mean|2.723||0.763|2-Sided|95.0|-6.2|4.55||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688572|NCT01133379|3106290|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|2.726||0.86|2-Sided|95.0|-5.86|4.9||The significance threshold level was 0.05 (two-sided), with no multiple comparisons adjustment.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity VAS score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688573|NCT01133379|3106291|Superiority or Other||Mean Difference (Final Values)|-0.96|Standard Error of the Mean|1.336||0.472|2-Sided|95.0|-3.6|1.67||The significance threshold was 0.05. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688574|NCT01133379|3106291|Superiority or Other||Mean Difference (Final Values)|-0.95|Standard Error of the Mean|1.336||0.477|2-Sided|95.0|-3.59|1.69||The significance threshold was 0.05. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688575|NCT01133379|3106292|Superiority or Other||Mean Difference (Final Values)|-3.99|Standard Error of the Mean|2.613||0.129|2-Sided|95.0|-9.15|1.17||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 2 (p<0.05), testing for 12027-020 versus vehicle control proceeded to Week 1. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688576|NCT01133379|3106292|Superiority or Other||Mean Difference (Final Values)|0.32|Standard Error of the Mean|2.613||0.904|2-Sided|95.0|-4.84|5.47||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 2 (p<0.05), testing for 12027-019 versus vehicle control proceeded to Week 1. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688577|NCT01133379|3106293|Superiority or Other||Mean Difference (Final Values)|-4.92|Standard Error of the Mean|3.969||0.217|2-Sided|95.0|-12.8|2.92||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 4 (p<0.05), testing for 12027-020 versus vehicle control proceeded to Week 2. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688578|NCT01133379|3106293|Superiority or Other||Mean Difference (Final Values)|1.12|Standard Error of the Mean|3.969||0.779|2-Sided|95.0|-6.72|8.95||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 4 (p<0.05), testing for 12027-019 versus vehicle control proceeded to Week 2. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688579|NCT01133379|3106294|Superiority or Other||Mean Difference (Final Values)|-7.75|Standard Error of the Mean|4.75||0.105|2-Sided|95.0|-17.1|1.63||Per statistical analysis plan, if experimental rinse (12027-020) was better than vehicle control at Week 6 (p<0.05), testing for 12027-020 versus vehicle control proceeded to Week 4. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688580|NCT01133379|3106294|Superiority or Other||Mean Difference (Final Values)|-1.14|Standard Error of the Mean|4.75||0.811|2-Sided|95.0|-10.5|8.24||Per statistical analysis plan, if experimental rinse (12027-019) was better than vehicle control at Week 6 (p<0.05), testing for 12027-019 versus vehicle control proceeded to Week 4. Family-wise error rate was controlled at 0.05.|ANCOVA|Terms included treatment and baseline mean tactile sensitivity (Yeaple probe) score.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1688581|NCT01132118|3106434|Superiority or Other|||||||0.884||||||P-value adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxycholorquine versus placebo from a linear regression model.|
1688582|NCT01132118|3106434|Superiority or Other|||||||0.487||||||Unadjusted P-value.|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.|
1688583|NCT01132118|3106435|Superiority or Other|||||||0.208||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.|
1688584|NCT01132118|3106435|Superiority or Other|||||||0.73||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.|
1688585|NCT01132118|3106436|Superiority or Other|||||||0.011||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.|
1688586|NCT01132118|3106436|Superiority or Other|||||||0.009||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference between the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.|
1688590|NCT01132118|3106438|Superiority or Other|||||||0.468||||||Unadjusted|Wilcoxon (Mann-Whitney)|||P-value for the difference betweeen change during hydroxychloroquine versus placebo suing Wilcoxon signed-rank tests.|
1688591|NCT01132118|3106439|Superiority or Other|||||||0.308||||||Adjusted for weight change.|Regression, Linear|||P-value for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.|
1688592|NCT01132118|3106439|Superiority or Other|||||||0.575||||||Unadjusted P-value|Wilcoxon (Mann-Whitney)|||P-value for the difference between change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.|
1688593|NCT01132118|3106440|Superiority or Other|||||||0.785||||||Adjusted for weight change.|Regression, Linear|||The P-value was calculated for the difference between the change during hydroxychloroquine versus placebo from a linear regression model.|
1688594|NCT01132118|3106440|Superiority or Other|||||||0.93||||||Unadjusted|Wilcoxon (Mann-Whitney)|||The P-value calculated was for the difference betweeen the change during hydroxychloroquine versus placebo using Wilcoxon signed-rank tests.|
1688595|NCT01131676|3106442|Superiority or Other||Hazard Ratio (HR)|0.62|||<|0.0001|2-Sided|95.0|0.54|0.7||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo||
1688596|NCT01131676|3106443|Superiority or Other||Hazard Ratio (HR)|0.62|||<|0.0001|2-Sided|95.0|0.54|0.72||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo||
1688597|NCT01131676|3106444|Superiority or Other||Hazard Ratio (HR)|0.95||||0.2547|2-Sided|95.0|0.87|1.04||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo||
1688598|NCT01131676|3106445|Superiority or Other||Hazard Ratio (HR)|0.65||||0.0017|2-Sided|95.0|0.5|0.85||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo||
1688599|NCT01131676|3106446|Superiority or Other||Hazard Ratio (HR)|1.28||||0.4172|2-Sided|95.0|0.7|2.33||Two-sided test with alpha = 0.05.|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo||
1688600|NCT01131676|3106447|Superiority or Other||Hazard Ratio (HR)|0.89||||0.0795|2-Sided|95.02|0.78|1.01||Two-sided test with alpha=0.0498|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.|
1688601|NCT01131676|3106447|Non-Inferiority or Equivalence|The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry – Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes|Hazard Ratio (HR)|0.89|||<|0.0001|2-Sided|95.02|0.78|1.01||One-sided test with alpha = 0.0249|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.|
1688602|NCT01131676|3106448|Superiority or Other||Hazard Ratio (HR)|0.86||||0.0382|2-Sided|95.02|0.74|0.99||Two-sided test with alpha=0.0498|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo||
1688603|NCT01131676|3106448|Non-Inferiority or Equivalence|The non-inferiority margin was chosen as 1.3 based on Food and Drug Administration (FDA) Guidance for Industry – Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes|Hazard Ratio (HR)|0.86|||<|0.0001|2-Sided|95.02|0.74|0.99||One-sided test with alpha = 0.0249|Cox proportional hazards model|Cox proportional hazards model with factors for treatment, age, gender, categorised BMI, HbA1c, eGFR and geographical region.|All Empagliflozin divided by Placebo|Primary objective was to establish the non-inferiority of All empagliflozin relative to placebo for time to first 3-point MACE. A 4-step hierarchical testing strategy was followed for the non-inferiority test of the primary endpoint and then the key secondary endpoint, each at a margin of 1.3, followed by test of superiority of primary and key secondary endpoints.|
1688604|NCT01131299|3106466|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1688605|NCT01131299|3106467|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1688606|NCT01131299|3106468|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1688607|NCT01131299|3106469|Superiority or Other|||||||0.82|||||||t-test, 2 sided|||The minimum sample size to detect an 8 mg/dl change in total plasma cholesterol between the placebo and alpha cyclodextrin periods is 62 subjects. The power is 80% by using the normal approximation to a one-sample (paired) two-tail t-test at an alpha of 0.05.|
1688608|NCT01131260|3106470|Superiority or Other|||||||0.05|||||||Chi-squared||||
1688609|NCT01131260|3106471|Superiority or Other|||||||0.98|||||||Chi-squared||||
1688610|NCT01131260|3106472|Superiority or Other|||||||0.54|||||||Wilcoxon (Mann-Whitney)||||
1688611|NCT01131260|3106473|Superiority or Other|||||||0.28|||||||Chi-squared||||
1688612|NCT01131260|3106474|Superiority or Other|||||||0.77|||||||Wilcoxon (Mann-Whitney)||||
1688613|NCT01131260|3106475|Superiority or Other|||||||0.19|||||||Chi-squared||||
1688614|NCT01131260|3106476|Superiority or Other|||||||0.59|||||||Chi-squared||||
1688615|NCT01131260|3106477|Superiority or Other|||||||0.4|||||||Chi-squared||||
1688616|NCT01131260|3106478|Superiority or Other|||||||0.35|||||||Chi-squared||||
1688617|NCT01131260|3106479|Superiority or Other|||||||0.32|||||||Wilcoxon (Mann-Whitney)||||
1688618|NCT01131260|3106481|Superiority or Other|||||||0.45||||||The p value was calculated based on the entire study cohort.|Chi-squared||||
1688619|NCT01131260|3106482|Superiority or Other|||||||0.17|||||||Chi-squared||||
1688620|NCT01131260|3106483|Superiority or Other||Risk Ratio (RR)|0.81||||1|2-Sided|95.0|0.22|3.0|||Fisher Exact||||
1688627|NCT01131182|3106492|Superiority or Other|||||||0.0005||||||Assessed for relative risk using prior therapy (monotherapy or combination therapy) as a stratification factor.|Cochran-Mantel-Haenszel||||
1688628|NCT01130740|3106582|Superiority or Other|||||||0.177|||||||Mixed Models Analysis||||
1688629|NCT01130740|3106583|Superiority or Other|||||||0.274|||||||Mixed Models Analysis|||This is the between-group 12-month comparison.|
1688630|NCT01130740|3106584|Superiority or Other|||||||0.008|||||||Mixed Models Analysis|||This is the 12-month comparison between the 2 study groups, which is the primary study analysis.|
1688631|NCT01130740|3106584|Superiority or Other|||||||0.158|||||||Mixed Models Analysis|||This is a comparison of 6-month outcomes between the two study groups. (Primary comparison is for 12 months.)|
1688632|NCT01130597|3106598|Superiority or Other||Percentage of Participants|84.1|||||2-Sided|95.0|72.7|92.1|||||Clopper-Pearson was used to arrive at the 95% Confidence Interval||
1688633|NCT01130597|3106603|Superiority or Other||Percentage of Participants|90.5|||||2-Sided|95.0|80.4|96.4|||||Clopper-Pearson was used to arrive at the 95% Confidence Interval||
1688634|NCT01130532|3106604|Superiority or Other||||||<|0.001||||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test||||
1688635|NCT01130532|3106604|Superiority or Other||||||<|0.004||||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test||||
1688636|NCT01130532|3106604|Superiority or Other||||||<|0.002||||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test||||
1688637|NCT01130532|3106605|Superiority or Other||||||<|0.001||||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test||||
1688638|NCT01130532|3106605|Superiority or Other||||||<|0.001||||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test||||
1688639|NCT01130532|3106605|Superiority or Other||||||<|0.001||||||Comparison of Week 16 to Week 12. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|Paired t-test||||
1688640|NCT01130532|3106607|Superiority or Other||LS Mean Difference|28.2|Standard Error of the Mean|2.74|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA||||
1688641|NCT01130532|3106607|Superiority or Other||LS Mean Difference|25.1|Standard Error of the Mean|2.76|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA||||
1688642|NCT01130532|3106608|Superiority or Other||LS Mean Difference|17.3|Standard Error of the Mean|2.86|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688643|NCT01130532|3106608|Superiority or Other||LS Mean Difference|15.1|Standard Error of the Mean|2.88|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688644|NCT01130532|3106608|Superiority or Other||LS Mean Difference|25.1|Standard Error of the Mean|2.56|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688645|NCT01130532|3106608|Superiority or Other||LS Mean Difference|25.2|Standard Error of the Mean|2.57|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688646|NCT01130532|3106608|Superiority or Other||LS Mean Difference|17.2|Standard Error of the Mean|2.35|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688647|NCT01130532|3106608|Superiority or Other||LS Mean Difference|16.9|Standard Error of the Mean|2.37|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688648|NCT01130532|3106608|Superiority or Other||LS Mean Difference|24.5|Standard Error of the Mean|2.44|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688649|NCT01130532|3106608|Superiority or Other||LS Mean Difference|22.3|Standard Error of the Mean|2.46|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688650|NCT01130532|3106608|Superiority or Other||LS Mean Difference|25.2|Standard Error of the Mean|2.78|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688651|NCT01130532|3106608|Superiority or Other||LS Mean Difference|21.7|Standard Error of the Mean|2.81|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688652|NCT01130532|3106609|Superiority or Other||LS Mean Difference|1.0|Standard Error of the Mean|0.11|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688653|NCT01130532|3106609|Superiority or Other||LS Mean Difference|0.9|Standard Error of the Mean|0.11|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688654|NCT01130532|3106610|Superiority or Other||LS Mean Difference|31.0|Standard Error of the Mean|2.76|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA||||
1688655|NCT01130532|3106610|Superiority or Other||LS Mean Difference|28.9|Standard Error of the Mean|2.77|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANOVA||||
1688687|NCT01130272|3106630|Superiority or Other (legacy)||Odds Ratio (OR)|0.719||||0.449|2-Sided|95.0|0.306|1.689|||ANCOVA||||
1690627|NCT01118455|3108499|Superiority or Other|||||||0.727|||||||Wilcoxon (Mann-Whitney)||||
1688656|NCT01130532|3106611|Superiority or Other||LS Mean Difference|20.1|Standard Error of the Mean|2.64|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688657|NCT01130532|3106611|Superiority or Other||LS Mean Difference|19.3|Standard Error of the Mean|2.65|<|0.001||95.0||||P-value is for satisfaction with orgasm. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688658|NCT01130532|3106611|Superiority or Other||LS Mean Difference|28.7|Standard Error of the Mean|2.53|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688659|NCT01130532|3106611|Superiority or Other||LS Mean Difference|26.0|Standard Error of the Mean|2.54|<|0.001||95.0||||P-value is for erectile function satisfaction. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688660|NCT01130532|3106611|Superiority or Other||LS Mean Difference|19.5|Standard Error of the Mean|2.2|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688661|NCT01130532|3106611|Superiority or Other||LS Mean Difference|19.3|Standard Error of the Mean|2.21|<|0.001||95.0||||P-value is for pleasure from sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688662|NCT01130532|3106611|Superiority or Other||LS Mean Difference|20.6|Standard Error of the Mean|2.35|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688663|NCT01130532|3106611|Superiority or Other||LS Mean Difference|19.9|Standard Error of the Mean|2.36|<|0.001||95.0||||P-value is for ease of erection. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688664|NCT01130532|3106611|Superiority or Other||LS Mean Difference|25.4|Standard Error of the Mean|2.48|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688665|NCT01130532|3106611|Superiority or Other||LS Mean Difference|23.1|Standard Error of the Mean|2.49|<|0.001||95.0||||P-value is for confidence to complete sexual activity. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688666|NCT01130532|3106612|Superiority or Other||LS Mean Difference|30.5|Standard Error of the Mean|3.75|<|0.001||95.0||||P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688667|NCT01130532|3106612|Superiority or Other||LS Mean Difference|33.0|Standard Error of the Mean|3.78|<|0.001||95.0||||P-value is for Question 5. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688668|NCT01130532|3106612|Superiority or Other||LS Mean Difference|31.3|Standard Error of the Mean|3.79|<|0.001||95.0||||P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688669|NCT01130532|3106612|Superiority or Other||LS Mean Difference|32.7|Standard Error of the Mean|3.82|<|0.001||95.0||||P-value is for Question 4. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688670|NCT01130532|3106612|Superiority or Other||LS Mean Difference|26.8|Standard Error of the Mean|3.5|<|0.001||95.0||||P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688671|NCT01130532|3106612|Superiority or Other||LS Mean Difference|24.7|Standard Error of the Mean|3.53|<|0.001||95.0||||P-value is for Question 3. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688672|NCT01130532|3106612|Superiority or Other||LS Mean Difference|19.3|Standard Error of the Mean|3.12|<|0.001||95.0||||P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688673|NCT01130532|3106612|Superiority or Other||LS Mean Difference|19.3|Standard Error of the Mean|3.14|<|0.001||95.0||||P-value is for Question 2. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688674|NCT01130532|3106612|Superiority or Other||LS Mean Difference|9.6|Standard Error of the Mean|2.26|<|0.001||95.0||||P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688675|NCT01130532|3106612|Superiority or Other||LS Mean Difference|10.4|Standard Error of the Mean|2.28|<|0.001||95.0||||P-value is for Question 1. Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688676|NCT01130532|3106613|Superiority or Other||LS Mean Difference|1.7|Standard Error of the Mean|0.22|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688677|NCT01130532|3106613|Superiority or Other||LS Mean Difference|1.7|Standard Error of the Mean|0.23|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688678|NCT01130532|3106614|Superiority or Other||LS Mean Difference|2.0|Standard Error of the Mean|0.29|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688679|NCT01130532|3106614|Superiority or Other||LS Mean Difference|2.1|Standard Error of the Mean|0.29|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688680|NCT01130532|3106615|Superiority or Other||LS Mean Difference|6.2|Standard Error of the Mean|0.68|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688681|NCT01130532|3106615|Superiority or Other||LS Mean Difference|6.1|Standard Error of the Mean|0.69|<|0.001||95.0||||Sequential gatekeeping strategies were applied for multiplicity control and the p-value was not adjusted.|ANCOVA||||
1688682|NCT01130532|3106616|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1688689|NCT01130272|3106631|Superiority or Other (legacy)||Odds Ratio (OR)|2.079||||0.09|2-Sided|95.0|0.893|4.842|||ANCOVA||||
1688690|NCT01130272|3106631|Superiority or Other (legacy)||Odds Ratio (OR)|2.383||||0.041|2-Sided|95.0|1.036|5.478|||ANCOVA||||
1688691|NCT01130272|3106631|Superiority or Other (legacy)||Odds Ratio (OR)|2.457||||0.052|2-Sided|95.0|0.994|6.077|||ANCOVA||||
1688692|NCT01130168|3106632|Superiority or Other||Mean Difference (Final Values)|-8.5|||<|0.0005|2-Sided|95.0|-12.7|-4.3|||ANOVA||||
1688693|NCT01130168|3106632|Superiority or Other||Mean Difference (Final Values)|-2.4|||<|0.267|2-Sided|95.0|-6.6|1.8|||ANOVA||||
1688694|NCT01130168|3106633|Superiority or Other||Mean Difference (Final Values)|-3.0||||0.039|2-Sided|95.0|-5.8|-0.2|||ANOVA||||
1688695|NCT01130168|3106633|Superiority or Other||Mean Difference (Final Values)|-9.0|||<|0.0005|2-Sided|95.0|-11.8|-6.2|||ANOVA||||
1688696|NCT01130168|3106634|Superiority or Other||Mean Difference (Final Values)|-15.3|||<|0.0005|2-Sided|95.0|-20.7|-9.8|||ANOVA||||
1688697|NCT01130168|3106634|Superiority or Other||Mean Difference (Final Values)|-4.4|||<|0.112|2-Sided|95.0|-9.9|1.0|||ANOVA||||
1688698|NCT01130168|3106635|Superiority or Other||Mean Difference (Final Values)|-4.8||||0.015|2-Sided|95.0|-8.5|-1.0|||ANOVA||||
1688699|NCT01130168|3106635|Superiority or Other||Mean Difference (Final Values)|-13.7|||<|0.0005|2-Sided|95.0|-17.5|-10.0|||ANOVA||||
1688700|NCT01130168|3106636|Superiority or Other||Mean Difference (Final Values)|-8.8|||<|0.0005|2-Sided|95.0|-13.1|-4.5|||ANOVA||||
1688701|NCT01130168|3106636|Superiority or Other||Mean Difference (Final Values)|-1.8|||<|0.428|2-Sided|95.0|-6.1|2.6|||ANOVA||||
1688702|NCT01130168|3106637|Superiority or Other||Mean Difference (Final Values)|-3.5||||0.035|2-Sided|95.0|-6.0|-0.3|||ANOVA||||
1688703|NCT01130168|3106637|Superiority or Other||Median Difference (Final Values)|-9.2|||<|0.0005|2-Sided|95.0|-12.1|-6.4|||ANOVA||||
1688704|NCT01130168|3106638|Superiority or Other||Mean Difference (Final Values)|-16.1|||<|0.0005|2-Sided|95.0|-21.7|-10.5|||ANOVA||||
1688705|NCT01130168|3106638|Superiority or Other||Mean Difference (Final Values)|-3.8|||<|0.186|2-Sided|95.0|-9.5|1.8|||ANOVA||||
1688706|NCT01130168|3106639|Superiority or Other||Mean Difference (Final Values)|-6.3||||0.001|2-Sided|95.0|-17.4|-6.3|||ANOVA||||
1688707|NCT01130168|3106639|Superiority or Other||Mean Difference (Final Values)|-17.4|||<|0.0005|2-Sided|95.0|-21.2|-10.1|||ANOVA||||
1688708|NCT01130168|3106640|Superiority or Other||Mean Difference (Final Values)|-5.9|||<|0.0005|2-Sided|95.0|-8.9|-2.9|||ANOVA||||
1688709|NCT01130168|3106640|Superiority or Other||Mean Difference (Final Values)|1.3|||<|0.407|2-Sided|95.0|-1.7|4.3|||ANOVA||||
1688710|NCT01130168|3106641|Superiority or Other||Mean Difference (Final Values)|-2.7||||0.016|2-Sided|95.0|-4.9|-0.6|||ANOVA||||
1688711|NCT01130168|3106641|Superiority or Other||Mean Difference (Final Values)|-13.1|||<|0.0005|2-Sided|95.0|-15.3|-10.9|||ANOVA||||
1688712|NCT01130103|3106642|Superiority or Other||Odds Ratio (OR)|20.8||||0.007|2-Sided|95.0|2.44|176.0|||Mixed Models Analysis|||rate of change over time in remission rate from week 5 to 10|
1688713|NCT01130103|3106642|Superiority or Other||Odds Ratio (OR)|12.6||||0.03|2-Sided|95.0|1.23|129.0|||Mixed Models Analysis|||treatment group effect: remission rate at weeks 5 and 10|
1688714|NCT01130103|3106646|Superiority or Other||incident rate ratio|0.56|||<|0.001|2-Sided|95.0|0.43|0.74|||Mixed Models Analysis|||rate of change in CAPS total from week 5 to week 10|
1688715|NCT01130103|3106646|Superiority or Other||incident rate ratio|0.5|||<|0.01|2-Sided|95.0|0.3|0.85|||Mixed Models Analysis|||caps total score at weeks 5 and 10|
1688716|NCT01129960|3106650|Superiority or Other|||||||0.1391|||||||Dunnett's test (analysis of covariance)||||
1688717|NCT01129960|3106650|Superiority or Other|||||||0.8034|||||||Dunnett's test (analysis of covariance)||||
1688718|NCT01129960|3106650|Superiority or Other|||||||0.3726|||||||Dunnett's test (analysis of covariance)||||
1688719|NCT01129765|3106658|Superiority or Other||Proportion|0.0|||||2-Sided|95.0|0.0|0.12||||||Descriptive summary of proportion found to have injury, with exact 95% confidnce interval from the binomial distribution.|
1688720|NCT01129765|3106659|Superiority or Other||Proportion|0.0|||||2-Sided|95.0|0.0|0.12||||||Descriptive summary of proportion observed to have a safety issue, with exact 95% confidnce interval from the binomial distribution.|
1688721|NCT01129765|3106660|Superiority or Other||Proportion|1.0|||||2-Sided|95.0|0.88|1.0||||||Descriptive summary of proportion responding >=3 on a 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.|
1688722|NCT01129765|3106661|Superiority or Other||Proportion|0.97||||0.0005|2-Sided|95.0|0.83|1.0|||One-sample proportion|||"Null hypothesis: Pr ≤ 0.7 versus HA: Pr > 0.7; Pr is proportion using device appropriately. Observed rate calculated with exact 95% confidence interval from the binomial distribution. 2-sided p-value from binomial distribution.~With the proposed sample size of 30 subjects, we will reject the primary null hypothesis if at least 27 are observed to use the device properly. We will have 80% power for this to occur provided that the true rate in the population is at least 92%."|
1688723|NCT01129765|3106662|Superiority or Other||Proportion|0.97|||||2-Sided|95.0|0.83|1.0||||||Descriptive summary of proportion responding >=3 on 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.|
1688724|NCT01129765|3106663|Superiority or Other||Proportion|0.97|||||2-Sided|95.0|0.83|1.0||||||Proportion responding >=3 on a 5-point likert scale, with exact 95% confidence interval from the binomial distribution.|
1688725|NCT01129583|3106667|Superiority or Other|||||||0.02|||||||t-test, 2 sided||||
1688726|NCT01129583|3106668|Superiority or Other|||||||0.01|||||||t-test, 2 sided||||
1688727|NCT01129583|3106669|Superiority or Other|||||||0.06|||||||t-test, 2 sided||||
1688728|NCT01129141|3106707|Superiority or Other||Mean Difference (Final Values)|-17.198|Standard Error of the Mean|2.88|<|0.0001|2-Sided|95.0|-22.86|-11.53|||Mixed Models Analysis||||
1688729|NCT01129128|3106709|Superiority or Other||Mean Difference (Final Values)|39.0||||0.34||95.0|||||Regression, Linear|controlled for baseline levels|||
1688730|NCT01129128|3106709|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.98||95.0|||||Regression, Linear|controlled for baseline levels|||
1688731|NCT01129128|3106710|Superiority or Other||Mean Difference (Final Values)|-12.0||||0.76||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values|||
1688732|NCT01129128|3106710|Superiority or Other||Mean Difference (Final Values)|-16.0||||0.9||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of Interferon gamma levels to account for skewed distribution of values|||
1688733|NCT01129128|3106711|Superiority or Other||Mean Difference (Final Values)|23472.0||||0.68||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values|||
1688734|NCT01129128|3106711|Superiority or Other||Mean Difference (Final Values)|-15793.0||||0.82||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of IL-6 levels to account for skewed distribution of values|||
1688735|NCT01129128|3106712|Superiority or Other||Mean Difference (Final Values)|705.0||||0.82||95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values||comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of .9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml|
1688736|NCT01129128|3106712|Superiority or Other||Mean Difference (Final Values)|-173.0||||0.87|2-Sided|95.0|||||Regression, Linear|controlled for baseline levels and performed log transformation of TNF alpha levels to account for skewed distribution of values||comparison of peak level of TNF alpha after controlling for baseline level. Based on data from 20 participants in a group, there was a power of 0.9 to detect a difference of 1000 pg/ml with a standard deviation of 700 pg/ml|
1688737|NCT01129011|3106726|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1688738|NCT01129011|3106727|Superiority or Other|||||||0.007|||||||Cochran-Mantel-Haenszel||||
1688739|NCT01129011|3106728|Superiority or Other|||||||0.009|||||||Cochran-Mantel-Haenszel||||
1688740|NCT01129011|3106729|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1688741|NCT01129011|3106730|Superiority or Other||proportions|11.9||||0.001|2-Sided|95.0|7.9|17.1|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjetcs developing gastric ulcers throughout 6 months of study treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 6 months. The cumulative proportion of subjects developing gastric ulcers at 6 months was analyzed using the CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.|
1688742|NCT01128972|3106731|Superiority or Other||Adjusted Mean Difference|7.14|||<|0.0001|2-Sided|95.0|4.11|10.18||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688743|NCT01128972|3106732|Superiority or Other||Adjusted Mean Difference|14.94|||||2-Sided|95.0|10.36|19.51|||||Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Test Dentifrice + Sterile water rinse treatment regimen andReference Dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.|
1688744|NCT01128972|3106733|Superiority or Other||Adjusted Mean Difference|7.17|||<|0.0001|2-Sided|95.0|4.14|10.21||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Placebo dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688745|NCT01128972|3106733|Superiority or Other||Adjusted Mean Difference|6.87|||<|0.0001|2-Sided|95.0|3.83|9.9||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR treatment regimen and Reference Dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688746|NCT01128972|3106733|Superiority or Other||Adjusted Mean Difference|-0.28|||<|0.8571|2-Sided|95.0|-3.31|2.76||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688747|NCT01128972|3106733|Superiority or Other||Adjusted Mean Difference|-4.39|||<|0.0049|2-Sided|95.0|-7.43|-1.35||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment|Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Test dentifrice + Test MR to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688772|NCT01128738|3106803|Superiority or Other||Percentage difference|50.2|||<|0.001|2-Sided|95.0|38.1|62.3|||Fisher Exact||Percentage difference was estimated as BTX 50 U minus placebo.||
1688773|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-29.59|||||2-Sided|95.0|-59.82|0.64||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14|
1688748|NCT01128972|3106734|Superiority or Other||Adjusted Mean Difference|36.29|||<|0.0001|2-Sided|95.0|31.71|40.86||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and Placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.|
1688749|NCT01128972|3106734|Superiority or Other||Adjusted Mean Difference|25.72|||<|0.0001|2-Sided|95.0|21.14|30.29||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ Test MR treatment regimen and Reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.|
1688750|NCT01128972|3106734|Superiority or Other||Adjusted Mean Difference|10.78|||<|0.0001|2-Sided|95.0|6.21|15.36||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.|
1688751|NCT01128972|3106734|Superiority or Other||Adjusted Mean Difference|-0.88|||<|0.7041|2-Sided|95.0|-5.46|3.69||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the Placebo Dentifrice + Test MR and Test dentifrice+ Test MR treatment regimen treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.|
1688752|NCT01128972|3106735|Superiority or Other||Adjusted Mean Difference|11.56|||<|0.0001|2-Sided|95.0|8.53|14.6||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect)|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688753|NCT01128972|3106735|Superiority or Other||Adjusted Mean DIfference|11.25|||<|0.0001|2-Sided|95.0|8.22|14.29||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect)|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + Sterile water rinse treatment regimen to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688754|NCT01128972|3106735|Superiority or Other||Adjusted Mean Difference|4.11|||<|0.0083|2-Sided|95.0|1.07|7.15||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + Sterile water rinse to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688755|NCT01128972|3106736|Superiority or Other||Adjusted Mean Difference|37.17|||<|0.0001|2-Sided|95.0|32.59|41.74||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and placebo dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.|
1688756|NCT01128972|3106736|Superiority or Other||Adjusted Mean DIfference|26.6|||<|0.0001|2-Sided|95.0|22.02|31.18||No adjustments made for multiple comparisons as primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and reference dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.|
1688757|NCT01128972|3106736|Superiority or Other||Adjusted Mean Difference|11.66|||<|0.0001|2-Sided|95.0|7.09|16.24||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis considered population means for the test dentifrice+ test MR treatment regimen and test dentifrice + sterile water rinse treatment regimen to be equal with respect to percent NER. Statistical tests were 2-sided with a significance level of 0.05.|
1688758|NCT01128946|3106738|Superiority or Other||Adjusted Mean Difference|-5.18|||<|0.0001|2-Sided|95.0|-6.95|-3.41||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.|
1690628|NCT01118455|3108500|Superiority or Other|||||||0.62|||||||Cochran-Mantel-Haenszel||||
1688759|NCT01128946|3106738|Superiority or Other||Adjusted Mean Difference|-0.77|||<|0.3942|2-Sided|95.0|-2.54|1.0||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.|
1688760|NCT01128946|3106738|Superiority or Other||Adjusted Mean Difference|4.41|||<|0.0001|2-Sided|95.0|2.66|6.16||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.|
1688761|NCT01128946|3106738|Superiority or Other||Adjusted Mean Difference|8.03|||<|0.0001|2-Sided|95.0|6.25|9.8||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.|
1688762|NCT01128946|3106738|Superiority or Other||Adjusted Mean Difference|8.79|||<|0.0001|2-Sided|95.0|7.04|10.55||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.|
1688763|NCT01128946|3106738|Superiority or Other||Adjusted Mean Difference|13.21|||<|0.0001|2-Sided|95.0|11.46|14.96||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to enamel fluoride uptake. Statistical tests were 2-sided with a significance level of 0.05.|
1688764|NCT01128946|3106739|Superiority or Other||Adjusted Mean Difference|-10.85|||<|0.0001|2-Sided|95.0|-14.3|-7.4||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688765|NCT01128946|3106739|Superiority or Other||Adjusted Mean Difference|1.46|||<|0.407|2-Sided|95.0|-2.0|4.91||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688766|NCT01128946|3106739|Superiority or Other||Adjusted Mean Difference|12.31|||<|0.0001|2-Sided|95.0|8.9|15.72||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688767|NCT01128946|3106739|Superiority or Other||Adjusted Mean Difference|12.2|||<|0.0001|2-Sided|95.0|8.74|15.67||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688768|NCT01128946|3106739|Superiority or Other||Adjusted Mean Difference|10.75|||<|0.0001|2-Sided|95.0|7.33|14.17||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688769|NCT01128946|3106740|Superiority or Other||Adjusted Mean Difference|23.06|||<|0.0001|2-Sided|95.0|19.63|26.48||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means for treatments in comparison, to be equal with respect to percent SMH recovery. Statistical tests were 2-sided with a significance level of 0.05.|
1688770|NCT01128894|3106747|Non-Inferiority or Equivalence|The p-value was from a 1-sided t test testing whether or not the difference of least square means (albiglutide – liraglutide) was less than or equal to the prespecified noninferiority margin of 0.3%.|Mean Difference (Final Values)|0.21||||0.0846|2-Sided|95.0|0.08|0.34|||ANCOVA||||
1688771|NCT01128829|3106755|Superiority or Other|||||||0.025|||||||t-test, 2 sided|||Each subject served as their own control. We compared insulin concentrations when subjects consumed sucralose before a glucose load (experimental condition) with those on the day consumed water before a glucose load (control condition).|
1690279|NCT01120028|3108205|Other||Hazard Ratio (HR)|1.23||||0.58|2-Sided|95.0|0.59|2.55|||Regression, Cox||||
1688774|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-45.749|||||2-Sided|95.0|-76.2|-15.3||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14|
1688775|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-12.397|||||2-Sided|95.0|-42.1|17.3||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14|
1688776|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-7.963|||||2-Sided|95.0|-37.2|21.27||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14|
1688777|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-37.552|||||2-Sided|95.0|-66.24|-8.86||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-24), Day 14|
1688778|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-53.712|||||2-Sided|95.0|-82.92|-24.5||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-24), Day 14|
1688779|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-20.359|||||2-Sided|95.0|-48.95|8.23||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-24), Day 14|
1688780|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-27.11|||||2-Sided|95.0|-59.8|5.58||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14|
1688781|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-48.762|||||2-Sided|95.0|-81.58|-15.95||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14|
1688782|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-8.539|||||2-Sided|95.0|-40.44|23.36||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14|
1688783|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-9.896|||||2-Sided|95.0|-41.31|21.52||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14|
1688784|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-37.006|||||2-Sided|95.0|-67.96|-6.05||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 14|
1688785|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-58.658|||||2-Sided|95.0|-90.08|-27.24||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 14|
1688786|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-18.435|||||2-Sided|95.0|-49.15|12.28||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 14|
1688787|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-19.227|||||2-Sided|95.0|-51.83|13.37||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7|
1688788|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-42.46|||||2-Sided|95.0|-75.18|-9.74||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7|
1688789|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-23.181|||||2-Sided|95.0|-55.0|8.63||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7|
1688790|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-5.438|||||2-Sided|95.0|-36.76|25.89||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7|
1688791|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-24.665|||||2-Sided|95.0|-55.53|6.2||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 7|
1688792|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-47.898|||||2-Sided|95.0|-79.23|-16.56||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 7|
1688793|NCT01128621|3106805|Superiority or Other||Mean Difference (Net)|-28.619|||||2-Sided|95.0|-59.25|2.01||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 7|
1688794|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|1.869|||||2-Sided|95.0|0.79|2.95||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14|
1688795|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|1.36|||||2-Sided|95.0|0.23|2.49||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14|
1688796|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|0.475|||||2-Sided|95.0|-0.62|1.57||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14|
1688797|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|-0.623|||||2-Sided|95.0|-1.71|0.46||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-24), Day 14|
1688798|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|1.245|||||2-Sided|95.0|0.21|2.28||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-24), Day 14|
1688799|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|0.737|||||2-Sided|95.0|-0.34|1.81||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-24), Day 14|
1688800|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|-0.148|||||2-Sided|95.0|-1.21|0.91||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-24), Day 14|
1688801|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|1.729|||||2-Sided|95.0|0.63|2.83||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14|
1688802|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|1.248|||||2-Sided|95.0|0.09|2.4||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14|
1688803|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|0.542|||||2-Sided|95.0|-0.58|1.66||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14|
1688804|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|-0.854|||||2-Sided|95.0|-1.95|0.25||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 14|
1688805|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|0.875|||||2-Sided|95.0|-0.18|1.93||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 14|
1688806|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|0.394|||||2-Sided|95.0|-0.7|1.49||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 14|
1688807|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|-0.312|||||2-Sided|95.0|-1.38|0.76||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 14|
1688808|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|1.985|||||2-Sided|95.0|0.96|3.01||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7|
1688809|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|1.468|||||2-Sided|95.0|0.39|2.55||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7|
1688810|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|0.454|||||2-Sided|95.0|-0.59|1.5||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7|
1688811|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|-0.955|||||2-Sided|95.0|-1.98|0.07||||||Placebo vs Sitagliptin 50 mg: Weighted Mean (0-12), Day 7|
1688812|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|1.03|||||2-Sided|95.0|0.05|2.01||||||Placebo vs GSK1292263 600 mg: Weighted Mean (0-12), Day 7|
1690280|NCT01120028|3108206|Other|||||||0.5|||||||ANCOVA||||
1688813|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|0.513|||||2-Sided|95.0|-0.51|1.54||||||Placebo vs GSK1292263 300 mg: Weighted Mean (0-12), Day 7|
1688814|NCT01128621|3106806|Superiority or Other||Mean Difference (Net)|-0.5|||||2-Sided|95.0|-1.5|0.5||||||Placebo vs GSK1292263 75 mg: Weighted Mean (0-12), Day 7|
1688815|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-26.703|||||2-Sided|95.0|-52.98|-0.42||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, 24 hours|
1688816|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-31.07|||||2-Sided|95.0|-57.66|-4.48||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, 24 hours|
1688817|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-22.194|||||2-Sided|95.0|-48.07|3.69||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, 24 hours|
1688818|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|3.094|||||2-Sided|95.0|-22.34|28.53||||||Placebo vs Sitagliptin 50 mg: Day 14, 24 hours|
1688819|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-23.609|||||2-Sided|95.0|-48.82|1.6||||||Placebo vs GSK1292263 600 mg: Day 14, 24 hours|
1688820|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-27.976|||||2-Sided|95.0|-53.56|-2.39||||||Placebo vs GSK1292263 300 mg: Day 14, 24 hours|
1688821|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-19.101|||||2-Sided|95.0|-44.0|5.8||||||Placebo vs GSK1292263 75 mg: Day 14, 24 hours|
1688822|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-17.662|||||2-Sided|95.0|-34.72|-0.6||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast|
1688823|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-12.07|||||2-Sided|95.0|-28.82|4.68||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast|
1688824|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|0.941|||||2-Sided|95.0|-15.4|17.28||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast|
1688825|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-4.59|||||2-Sided|95.0|-20.69|11.51||||||Placebo vs Sitagliptin 50 mg: Day 14, pre-breakfast|
1688826|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-22.251|||||2-Sided|95.0|-38.34|-6.16||||||Placebo vs GSK1292263 600 mg: Day 14, pre-breakfast|
1688827|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-16.66|||||2-Sided|95.0|-32.72|-0.6||||||Placebo vs GSK1292263 300 mg: Day 14, pre-breakfast|
1688828|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-3.649|||||2-Sided|95.0|-19.43|12.14||||||Placebo vs GSK1292263 75 mg: Day 14, pre-breakfast|
1688829|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-9.31|||||2-Sided|95.0|-27.63|9.01||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast|
1688830|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-20.712|||||2-Sided|95.0|-39.25|-2.17||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast|
1688831|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-3.655|||||2-Sided|95.0|-21.7|14.39||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast|
1688832|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|3.85|||||2-Sided|95.0|-13.89|21.58||||||Placebo vs Sitagliptin 50 mg: Day 7, pre-breakfast|
1688833|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-5.46|||||2-Sided|95.0|-23.04|12.12||||||Placebo vs GSK1292263 600 mg: Day 7, pre-breakfast|
1688834|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|-16.863|||||2-Sided|95.0|-34.7|0.98||||||Placebo vs GSK1292263 300 mg: Day 7, pre-breakfast|
1688835|NCT01128621|3106809|Superiority or Other||Mean Difference (Net)|0.195|||||2-Sided|95.0|-17.17|17.56||||||Placebo vs GSK1292263 75 mg: Day 7, pre-breakfast|
1688836|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|1.741|||||2-Sided|95.0|0.63|2.86||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, 24 hours|
1688837|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|1.775|||||2-Sided|95.0|0.6|2.95||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, 24 hours|
1688838|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|0.474|||||2-Sided|95.0|-0.66|1.61||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, 24 hours|
1688839|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|-1.03|||||2-Sided|95.0|-2.15|0.09||||||Placebo vs Sitagliptin 50 mg: Day 14, 24 hours|
1688840|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|0.711|||||2-Sided|95.0|-0.36|1.78||||||Placebo vs GSK1292263 600 mg: Day 14, 24 hours|
1688841|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|0.745|||||2-Sided|95.0|-0.4|1.89||||||Placebo vs GSK1292263 300 mg: Day 14, 24 hours|
1688842|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|-0.556|||||2-Sided|95.0|-1.65|0.54||||||Placebo vs GSK1292263 75 mg: Day 14, 24 hours|
1688843|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|1.669|||||2-Sided|95.0|0.68|2.65||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast|
1688844|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|1.257|||||2-Sided|95.0|0.22|2.29||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast|
1688845|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|0.289|||||2-Sided|95.0|-0.71|1.29||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 14, pre-breakfast|
1688846|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|-1.069|||||2-Sided|95.0|-2.05|-0.08||||||Placebo vs Sitagliptin 50 mg: Day 14, pre-breakfast|
1688847|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|0.6|||||2-Sided|95.0|-0.35|1.55||||||Placebo vs GSK1292263 600 mg: Day 14, pre-breakfast|
1688848|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|0.188|||||2-Sided|95.0|-0.81|1.19||||||Placebo vs GSK1292263 300 mg: Day 14, pre-breakfast|
1688849|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|-0.78|||||2-Sided|95.0|-1.74|0.18||||||Placebo vs GSK1292263 75 mg: Day 14, pre-breakfast|
1688850|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|1.955|||||2-Sided|95.0|1.16|2.75||||||GSK1292263 600 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast|
1688851|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|1.497|||||2-Sided|95.0|0.66|2.34||||||GSK1292263 300 mg vs Sitagliptin 50 mg: Day 7, pre-breakfast|
1688852|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|0.991|||||2-Sided|95.0|0.18|1.81||||||GSK1292263 75 mg vs Sitagliptin 50 mg: Day 7 , pre-breakfast|
1688853|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|-1.207|||||2-Sided|95.0|-2.01|-0.41||||||Placebo vs Sitagliptin 50 mg: Day 7, pre-breakfast|
1688854|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|0.748|||||2-Sided|95.0|-0.02|1.52||||||Placebo vs GSK1292263 600 mg: Day 7, pre-breakfast|
1688855|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|0.29|||||2-Sided|95.0|-0.53|1.11||||||Placebo vs GSK1292263 300 mg: Day 7, pre-breakfast|
1688856|NCT01128621|3106810|Superiority or Other||Mean Difference (Net)|-0.216|||||2-Sided|95.0|-1.0|0.57||||||Placebo vs GSK1292263 75 mg: Day 7, pre-breakfast|
1688857|NCT01128595|3106843|Superiority or Other||Mean Difference (Final Values)|0.026|||||2-Sided|95.0|-0.118|0.171|||||||
1688858|NCT01128595|3106843|Superiority or Other||Mean Difference (Final Values)|0.174|||||2-Sided|95.0|0.036|0.312|||||||
1688859|NCT01128595|3106843|Superiority or Other||Mean Difference (Final Values)|0.263|||||2-Sided|95.0|0.127|0.398|||||||
1688860|NCT01128595|3106843|Superiority or Other||Mean Difference (Final Values)|0.236|||||2-Sided|95.0|0.101|0.371|||||||
1688861|NCT01128595|3106843|Superiority or Other||Mean Difference (Final Values)|0.089|||||2-Sided|95.0|-0.037|0.215|||||||
1688862|NCT01128595|3106844|Superiority or Other||Mean Difference (Final Values)|0.135|||||2-Sided|95.0|-0.072|0.343|||||||
1688863|NCT01128595|3106844|Superiority or Other||Mean Difference (Final Values)|0.265|||||2-Sided|95.0|0.066|0.463|||||||
1688864|NCT01128595|3106844|Superiority or Other||Mean Difference (Final Values)|0.477|||||2-Sided|95.0|0.282|0.672|||||||
1688865|NCT01128595|3106844|Superiority or Other||Mean Difference (Final Values)|0.341|||||2-Sided|95.0|0.147|0.536|||||||
1688866|NCT01128595|3106844|Superiority or Other||Mean Difference (Final Values)|0.212|||||2-Sided|95.0|0.031|0.393|||||||
1688867|NCT01128595|3106845|Superiority or Other||Mean Difference (Final Values)|0.316|||||2-Sided|95.0|0.168|0.464|||||||
1688868|NCT01128595|3106845|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.14|0.14|||||||
1688869|NCT01128595|3106845|Superiority or Other||Mean Difference (Final Values)|0.168|||||2-Sided|95.0|0.009|0.327|||||||
1688870|NCT01128595|3106845|Superiority or Other||Mean Difference (Final Values)|0.484|||||2-Sided|95.0|0.33|0.638|||||||
1688871|NCT01128595|3106845|Superiority or Other||Mean Difference (Final Values)|0.484|||||2-Sided|95.0|0.332|0.636|||||||
1688872|NCT01128595|3106848|Superiority or Other||Mean Difference (Final Values)|0.32|||||2-Sided|95.0|0.14|0.501|||||||
1688873|NCT01128595|3106848|Superiority or Other||Mean Difference (Final Values)|-0.027|||||2-Sided|95.0|-0.198|0.143|||||||
1688874|NCT01128595|3106848|Superiority or Other||Mean Difference (Final Values)|0.195|||||2-Sided|95.0|0.001|0.388|||||||
1688875|NCT01128595|3106848|Superiority or Other||Mean Difference (Final Values)|0.543|||||2-Sided|95.0|0.355|0.73|||||||
1688876|NCT01128595|3106848|Superiority or Other||Mean Difference (Final Values)|0.515|||||2-Sided|95.0|0.33|0.701|||||||
1688877|NCT01128569|3106852|Superiority or Other||Mean Difference (Final Values)|-0.017|||||2-Sided|95.0|-0.091|0.057|||||||
1688878|NCT01128569|3106852|Superiority or Other||Mean Difference (Final Values)|0.145|||||2-Sided|95.0|0.069|0.222|||||||
1688879|NCT01128569|3106852|Superiority or Other||Mean Difference (Final Values)|0.162|||||2-Sided|95.0|0.087|0.237|||||||
1688880|NCT01128426|3106856|Superiority or Other|||||||0.68|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688881|NCT01128426|3106856|Superiority or Other|||||||0.04|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688882|NCT01128426|3106856|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688883|NCT01128426|3106856|Superiority or Other||||||<|0.07|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688884|NCT01128426|3106856|Superiority or Other||||||<|0.61|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688885|NCT01128426|3106856|Superiority or Other||||||<|0.06|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688886|NCT01128426|3106856|Superiority or Other||||||<|0.29|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688887|NCT01128426|3106856|Superiority or Other||||||<|0.21|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688888|NCT01128426|3106856|Superiority or Other||||||<|0.04|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688889|NCT01128426|3106856|Superiority or Other||||||<|0.24|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688890|NCT01128426|3106856|Superiority or Other||||||<|0.24|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688891|NCT01128426|3106856|Superiority or Other||||||<|0.23|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688892|NCT01128426|3106856|Superiority or Other||||||<|0.54|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688893|NCT01128426|3106856|Superiority or Other||||||<|0.07|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688894|NCT01128426|3106856|Superiority or Other||||||<|0.87|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688895|NCT01128426|3106856|Superiority or Other||||||<|0.17|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688896|NCT01128426|3106856|Superiority or Other||||||<|0.02|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688897|NCT01128426|3106856|Superiority or Other||||||<|0.22|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688898|NCT01128426|3106856|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688899|NCT01128426|3106856|Superiority or Other||||||<|0.04|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688900|NCT01128426|3106856|Superiority or Other||||||<|0.98|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688901|NCT01128426|3106856|Superiority or Other||||||<|0.08|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688902|NCT01128426|3106856|Superiority or Other||||||<|0.07|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688903|NCT01128426|3106856|Superiority or Other||||||<|0.16|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688904|NCT01128426|3106856|Superiority or Other||||||<|0.53|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688905|NCT01128426|3106856|Superiority or Other||||||<|0.69|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688906|NCT01128426|3106856|Superiority or Other||||||<|0.04|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688907|NCT01128426|3106856|Superiority or Other||||||<|0.67|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688908|NCT01128426|3106856|Superiority or Other||||||<|0.66|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688909|NCT01128426|3106856|Superiority or Other||||||<|0.21|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688910|NCT01128426|3106856|Superiority or Other||||||<|0.45|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688911|NCT01128426|3106856|Superiority or Other||||||<|0.03|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688912|NCT01128426|3106856|Superiority or Other||||||<|0.18|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688913|NCT01128426|3106856|Superiority or Other||||||<|0.57|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688914|NCT01128426|3106856|Superiority or Other||||||<|0.13|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688915|NCT01128426|3106856|Superiority or Other||||||<|0.95|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688916|NCT01128426|3106856|Superiority or Other||||||<|0.69|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688917|NCT01128426|3106856|Superiority or Other||||||<|0.28|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688918|NCT01128426|3106856|Superiority or Other||||||<|0.69|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688919|NCT01128426|3106856|Superiority or Other||||||<|0.49|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688920|NCT01128426|3106856|Superiority or Other||||||<|0.42|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688921|NCT01128426|3106856|Superiority or Other||||||<|0.46|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688922|NCT01128426|3106856|Superiority or Other||||||<|0.63|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688923|NCT01128426|3106856|Superiority or Other||||||<|0.05|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688924|NCT01128426|3106856|Superiority or Other||||||<|0.21|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688925|NCT01128426|3106856|Superiority or Other||||||<|0.17|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688926|NCT01128426|3106856|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1690281|NCT01120028|3108207|Other||Hazard Ratio (HR)|0.42|||<|0.0001|2-Sided|95.0|0.28|0.64|||Log Rank||||
1688927|NCT01128426|3106856|Superiority or Other||||||<|0.05|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688928|NCT01128426|3106856|Superiority or Other||||||<|0.93|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688929|NCT01128426|3106856|Superiority or Other||||||<|0.18|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688930|NCT01128426|3106856|Superiority or Other||||||<|0.02|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688931|NCT01128426|3106856|Superiority or Other||||||<|0.27|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688932|NCT01128426|3106856|Superiority or Other||||||<|0.02|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688933|NCT01128426|3106856|Superiority or Other||||||<|0.04|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688934|NCT01128426|3106857|Superiority or Other|||||||0.73|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688935|NCT01128426|3106857|Superiority or Other|||||||0.07|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688936|NCT01128426|3106857|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688937|NCT01128426|3106857|Superiority or Other||||||<|0.07|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688938|NCT01128426|3106857|Superiority or Other||||||<|0.72|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688939|NCT01128426|3106857|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688940|NCT01128426|3106857|Superiority or Other||||||<|0.69|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688941|NCT01128426|3106857|Superiority or Other||||||<|0.74|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688942|NCT01128426|3106857|Superiority or Other||||||<|0.07|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688943|NCT01128426|3106857|Superiority or Other||||||<|0.14|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688944|NCT01128426|3106857|Superiority or Other||||||<|0.23|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688945|NCT01128426|3106857|Superiority or Other||||||<|0.67|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688946|NCT01128426|3106857|Superiority or Other||||||<|0.96|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688947|NCT01128426|3106857|Superiority or Other||||||<|0.22|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688948|NCT01128426|3106857|Superiority or Other||||||<|0.31|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688949|NCT01128426|3106857|Superiority or Other||||||<|0.66|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688950|NCT01128426|3106857|Superiority or Other||||||<|0.63|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688951|NCT01128426|3106857|Superiority or Other||||||<|0.08|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688952|NCT01128426|3106857|Superiority or Other||||||<|0.18|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688953|NCT01128426|3106857|Superiority or Other||||||<|0.67|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688954|NCT01128426|3106857|Superiority or Other||||||<|0.85|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688955|NCT01128426|3106857|Superiority or Other||||||<|0.16|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688956|NCT01128426|3106857|Superiority or Other||||||<|0.37|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688957|NCT01128426|3106857|Superiority or Other||||||<|0.03|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1690629|NCT01118455|3108500|Superiority or Other|||||||0.168|||||||Cochran-Mantel-Haenszel||||
1688958|NCT01128426|3106857|Superiority or Other||||||<|0.24|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688959|NCT01128426|3106857|Superiority or Other||||||<|0.24|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688960|NCT01128426|3106857|Superiority or Other||||||<|0.05|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688961|NCT01128426|3106857|Superiority or Other||||||<|0.87|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688962|NCT01128426|3106857|Superiority or Other||||||<|0.7|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688963|NCT01128426|3106857|Superiority or Other||||||<|0.44|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688964|NCT01128426|3106857|Superiority or Other||||||<|0.48|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688965|NCT01128426|3106857|Superiority or Other||||||<|0.51|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688966|NCT01128426|3106857|Superiority or Other||||||<|0.5|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688967|NCT01128426|3106857|Superiority or Other||||||<|0.43|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688968|NCT01128426|3106857|Superiority or Other||||||<|0.31|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688969|NCT01128426|3106857|Superiority or Other||||||<|0.06|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688970|NCT01128426|3106857|Superiority or Other||||||<|0.41|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688971|NCT01128426|3106857|Superiority or Other||||||<|0.24|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688972|NCT01128426|3106857|Superiority or Other||||||<|0.32|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688973|NCT01128426|3106857|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688974|NCT01128426|3106857|Superiority or Other||||||<|0.93|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688975|NCT01128426|3106857|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688976|NCT01128426|3106857|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688977|NCT01128426|3106857|Superiority or Other||||||<|0.48|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688978|NCT01128426|3106857|Superiority or Other||||||<|0.43|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688979|NCT01128426|3106857|Superiority or Other||||||<|0.56|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688980|NCT01128426|3106858|Superiority or Other|||||||0.94|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688981|NCT01128426|3106858|Superiority or Other|||||||0.14|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688982|NCT01128426|3106858|Superiority or Other|||||||0.73|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688983|NCT01128426|3106858|Superiority or Other|||||||0.48|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688984|NCT01128426|3106858|Superiority or Other|||||||0.73|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688985|NCT01128426|3106858|Superiority or Other|||||||0.27|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688986|NCT01128426|3106858|Superiority or Other|||||||0.21|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688987|NCT01128426|3106858|Superiority or Other|||||||0.03|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688988|NCT01128426|3106858|Superiority or Other|||||||0.48|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1690630|NCT01118455|3108500|Superiority or Other|||||||0.22|||||||Cochran-Mantel-Haenszel||||
1688989|NCT01128426|3106858|Superiority or Other|||||||0.53|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688990|NCT01128426|3106858|Superiority or Other|||||||0.14|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688991|NCT01128426|3106858|Superiority or Other|||||||0.07|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688992|NCT01128426|3106858|Superiority or Other|||||||0.59|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688993|NCT01128426|3106858|Superiority or Other|||||||0.33|||||||mid-p exact binomial method]|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688994|NCT01128426|3106858|Superiority or Other|||||||0.02|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688995|NCT01128426|3106858|Superiority or Other|||||||0.85|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688996|NCT01128426|3106858|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688997|NCT01128426|3106858|Superiority or Other||||||<|0.06|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688998|NCT01128426|3106858|Superiority or Other||||||<|0.27|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1688999|NCT01128426|3106858|Superiority or Other||||||<|0.07|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689000|NCT01128426|3106858|Superiority or Other||||||<|0.59|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689001|NCT01128426|3106858|Superiority or Other||||||<|0.53|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689002|NCT01128426|3106858|Superiority or Other||||||<|0.69|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689003|NCT01128426|3106858|Superiority or Other||||||<|0.04|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689004|NCT01128426|3106858|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689005|NCT01128426|3106858|Superiority or Other||||||<|0.82|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689006|NCT01128426|3106858|Superiority or Other||||||<|0.93|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689007|NCT01128426|3106858|Superiority or Other||||||<|0.4|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689008|NCT01128426|3106858|Superiority or Other||||||<|0.27|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689009|NCT01128426|3106858|Superiority or Other||||||<|0.73|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689010|NCT01128426|3106858|Superiority or Other||||||<|0.92|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689011|NCT01128426|3106858|Superiority or Other||||||<|0.46|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689012|NCT01128426|3106858|Superiority or Other||||||<|0.79|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689013|NCT01128426|3106858|Superiority or Other||||||<|0.56|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689014|NCT01128426|3106858|Superiority or Other||||||<|0.93|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689015|NCT01128426|3106858|Superiority or Other||||||<|0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689016|NCT01128426|3106858|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689017|NCT01128426|3106858|Superiority or Other||||||<|0.95|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689018|NCT01128426|3106858|Superiority or Other||||||<|0.1|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689019|NCT01128426|3106858|Superiority or Other||||||<|0.59|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1690282|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-8.681|||||2-Sided|95.0|-24.02|6.66|||||Day 14, 24 Hours||
1689020|NCT01128426|3106858|Superiority or Other||||||<|0.41|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689021|NCT01128426|3106858|Superiority or Other||||||<|0.2|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689022|NCT01128426|3106858|Superiority or Other||||||<|0.4|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689023|NCT01128426|3106858|Superiority or Other||||||<|0.05|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689024|NCT01128426|3106858|Superiority or Other||||||<|0.26|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689025|NCT01128426|3106858|Superiority or Other||||||<|0.73|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689026|NCT01128426|3106858|Superiority or Other||||||<|0.13|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689027|NCT01128426|3106858|Superiority or Other||||||<|0.03|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689028|NCT01128426|3106858|Superiority or Other||||||<|0.03|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689029|NCT01128426|3106859|Superiority or Other|||||||0.03|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689030|NCT01128426|3106859|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689031|NCT01128426|3106859|Superiority or Other|||||||0.19|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689032|NCT01128426|3106859|Superiority or Other|||||||0.97|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689033|NCT01128426|3106859|Superiority or Other|||||||0.96|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689034|NCT01128426|3106859|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689035|NCT01128426|3106859|Superiority or Other|||||||0.99|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689036|NCT01128426|3106859|Superiority or Other|||||||0.99|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689037|NCT01128426|3106859|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689038|NCT01128426|3106859|Superiority or Other|||||||0.13|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689039|NCT01128426|3106859|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689040|NCT01128426|3106859|Superiority or Other|||||||0.81|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689041|NCT01128426|3106859|Superiority or Other|||||||0.22|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689042|NCT01128426|3106859|Superiority or Other|||||||0.17|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689043|NCT01128426|3106859|Superiority or Other|||||||0.65|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689044|NCT01128426|3106859|Superiority or Other|||||||0.78|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689045|NCT01128426|3106859|Superiority or Other|||||||0.38|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689046|NCT01128426|3106859|Superiority or Other|||||||0.82|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689047|NCT01128426|3106859|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689048|NCT01128426|3106859|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689049|NCT01128426|3106859|Superiority or Other|||||||0.12|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689050|NCT01128426|3106859|Superiority or Other|||||||0.37|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689051|NCT01128426|3106859|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689052|NCT01128426|3106859|Superiority or Other|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689053|NCT01128426|3106859|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689054|NCT01128426|3106859|Superiority or Other|||||||0.18|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689055|NCT01128426|3106859|Superiority or Other|||||||0.68|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689056|NCT01128426|3106859|Superiority or Other|||||||0.66|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689057|NCT01128426|3106859|Superiority or Other|||||||0.63|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689058|NCT01128426|3106859|Superiority or Other|||||||0.62|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689059|NCT01128426|3106859|Superiority or Other|||||||0.28|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689060|NCT01128426|3106859|Superiority or Other|||||||0.61|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689061|NCT01128426|3106859|Superiority or Other|||||||0.24|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689062|NCT01128426|3106859|Superiority or Other|||||||0.68|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689063|NCT01128426|3106859|Superiority or Other|||||||0.12|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689064|NCT01128426|3106859|Superiority or Other|||||||0.28|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689065|NCT01128426|3106859|Superiority or Other|||||||0.14|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689066|NCT01128426|3106859|Superiority or Other|||||||0.14|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689067|NCT01128426|3106859|Superiority or Other|||||||0.14|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689068|NCT01128426|3106859|Superiority or Other|||||||0.15|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689069|NCT01128426|3106859|Superiority or Other|||||||0.06|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689070|NCT01128426|3106859|Superiority or Other|||||||0.13|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689071|NCT01128426|3106859|Superiority or Other|||||||0.99|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689072|NCT01128426|3106859|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689073|NCT01128426|3106859|Superiority or Other|||||||0.62|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689074|NCT01128426|3106859|Superiority or Other|||||||0.23|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689075|NCT01128426|3106859|Superiority or Other|||||||0.73|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689076|NCT01128426|3106859|Superiority or Other|||||||0.13|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method.The null hypothesis was relative risk = 1.|
1689077|NCT01128426|3106859|Superiority or Other|||||||0.78|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689078|NCT01128426|3106859|Superiority or Other|||||||0.38|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689079|NCT01128426|3106860|Superiority or Other|||||||0.03|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689080|NCT01128426|3106860|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689081|NCT01128426|3106860|Superiority or Other|||||||0.31|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689082|NCT01128426|3106860|Superiority or Other|||||||0.97|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689083|NCT01128426|3106860|Superiority or Other|||||||0.64|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689084|NCT01128426|3106860|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689085|NCT01128426|3106860|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689086|NCT01128426|3106860|Superiority or Other|||||||0.06|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689087|NCT01128426|3106860|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689088|NCT01128426|3106860|Superiority or Other|||||||0.81|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689089|NCT01128426|3106860|Superiority or Other|||||||0.33|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689090|NCT01128426|3106860|Superiority or Other|||||||0.26|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689091|NCT01128426|3106860|Superiority or Other|||||||0.55|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689092|NCT01128426|3106860|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689093|NCT01128426|3106860|Superiority or Other|||||||0.82|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689094|NCT01128426|3106860|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689095|NCT01128426|3106860|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689096|NCT01128426|3106860|Superiority or Other|||||||0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689097|NCT01128426|3106860|Superiority or Other|||||||0.74|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689098|NCT01128426|3106860|Superiority or Other|||||||0.06|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689099|NCT01128426|3106860|Superiority or Other|||||||0.67|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689100|NCT01128426|3106860|Superiority or Other|||||||0.51|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689101|NCT01128426|3106860|Superiority or Other|||||||0.99|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689102|NCT01128426|3106860|Superiority or Other|||||||0.15|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689103|NCT01128426|3106860|Superiority or Other|||||||0.28|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689104|NCT01128426|3106860|Superiority or Other|||||||0.7|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689105|NCT01128426|3106860|Superiority or Other|||||||0.28|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689106|NCT01128426|3106860|Superiority or Other|||||||0.85|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689107|NCT01128426|3106860|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689108|NCT01128426|3106860|Superiority or Other|||||||0.21|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689109|NCT01128426|3106860|Superiority or Other|||||||0.14|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689110|NCT01128426|3106860|Superiority or Other|||||||0.22|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689111|NCT01128426|3106860|Superiority or Other|||||||0.22|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689112|NCT01128426|3106860|Superiority or Other|||||||0.43|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689113|NCT01128426|3106860|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689625|NCT01128192|3106908|Superiority or Other||||||<|0.001||||||Two sided P Value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes|
1689114|NCT01128426|3106860|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689115|NCT01128426|3106860|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689116|NCT01128426|3106860|Superiority or Other|||||||0.62|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689117|NCT01128426|3106860|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689118|NCT01128426|3106860|Superiority or Other|||||||0.55|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689119|NCT01128426|3106860|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689120|NCT01128426|3106860|Superiority or Other|||||||0.77|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689121|NCT01128426|3106860|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689122|NCT01128426|3106861|Superiority or Other|||||||0.98|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689123|NCT01128426|3106861|Superiority or Other|||||||0.21|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689124|NCT01128426|3106861|Superiority or Other|||||||0.28|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689125|NCT01128426|3106861|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689126|NCT01128426|3106861|Superiority or Other|||||||0.99|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689127|NCT01128426|3106861|Superiority or Other|||||||0.63|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689128|NCT01128426|3106861|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689129|NCT01128426|3106861|Superiority or Other|||||||0.99|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689130|NCT01128426|3106861|Superiority or Other|||||||0.41|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689131|NCT01128426|3106861|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689132|NCT01128426|3106861|Superiority or Other|||||||0.44|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689133|NCT01128426|3106861|Superiority or Other|||||||0.84|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689134|NCT01128426|3106861|Superiority or Other|||||||0.78|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689135|NCT01128426|3106861|Superiority or Other|||||||0.63|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689136|NCT01128426|3106861|Superiority or Other|||||||0.99|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689137|NCT01128426|3106861|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689138|NCT01128426|3106861|Superiority or Other|||||||0.12|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689139|NCT01128426|3106861|Superiority or Other|||||||0.37|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689140|NCT01128426|3106861|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689141|NCT01128426|3106861|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689142|NCT01128426|3106861|Superiority or Other|||||||0.13|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689143|NCT01128426|3106861|Superiority or Other|||||||0.99|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689144|NCT01128426|3106861|Superiority or Other|||||||0.75|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689145|NCT01128426|3106861|Superiority or Other|||||||0.81|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689146|NCT01128426|3106861|Superiority or Other|||||||0.04|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689147|NCT01128426|3106861|Superiority or Other|||||||0.98|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689148|NCT01128426|3106861|Superiority or Other|||||||0.36|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689149|NCT01128426|3106861|Superiority or Other|||||||0.7|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689150|NCT01128426|3106861|Superiority or Other|||||||0.53|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689151|NCT01128426|3106861|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689152|NCT01128426|3106861|Superiority or Other|||||||0.63|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689153|NCT01128426|3106861|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689154|NCT01128426|3106861|Superiority or Other|||||||0.53|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689155|NCT01128426|3106861|Superiority or Other|||||||0.11|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689156|NCT01128426|3106861|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689157|NCT01128426|3106861|Superiority or Other|||||||0.13|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689158|NCT01128426|3106861|Superiority or Other|||||||0.99|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689159|NCT01128426|3106861|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689160|NCT01128426|3106861|Superiority or Other|||||||0.38|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689161|NCT01128426|3106861|Superiority or Other|||||||0.6|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689162|NCT01128426|3106861|Superiority or Other|||||||0.03|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689163|NCT01128426|3106861|Superiority or Other|||||||0.73|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689164|NCT01128426|3106861|Superiority or Other|||||||0.63|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689165|NCT01128426|3106862|Superiority or Other|||||||0.48|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689166|NCT01128426|3106862|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689167|NCT01128426|3106862|Superiority or Other|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689168|NCT01128426|3106862|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689169|NCT01128426|3106862|Superiority or Other|||||||0.54|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689170|NCT01128426|3106862|Superiority or Other|||||||0.76|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689171|NCT01128426|3106862|Superiority or Other|||||||0.96|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689172|NCT01128426|3106862|Superiority or Other|||||||0.96|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689173|NCT01128426|3106862|Superiority or Other|||||||0.15|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689174|NCT01128426|3106862|Superiority or Other|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689175|NCT01128426|3106862|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1690631|NCT01118455|3108500|Superiority or Other|||||||0.507|||||||Cochran-Mantel-Haenszel||||
1689176|NCT01128426|3106862|Superiority or Other|||||||0.48|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689177|NCT01128426|3106862|Superiority or Other|||||||0.7|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689178|NCT01128426|3106862|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689179|NCT01128426|3106862|Superiority or Other|||||||0.34|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689180|NCT01128426|3106862|Superiority or Other|||||||0.3|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689181|NCT01128426|3106862|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689182|NCT01128426|3106862|Superiority or Other|||||||0.35|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689183|NCT01128426|3106862|Superiority or Other|||||||0.07|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689184|NCT01128426|3106862|Superiority or Other|||||||0.41|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689185|NCT01128426|3106862|Superiority or Other|||||||0.04|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689186|NCT01128426|3106862|Superiority or Other|||||||0.27|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689187|NCT01128426|3106862|Superiority or Other|||||||0.07|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689188|NCT01128426|3106862|Superiority or Other|||||||0.14|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689189|NCT01128426|3106862|Superiority or Other|||||||0.27|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689190|NCT01128426|3106862|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689191|NCT01128426|3106862|Superiority or Other|||||||0.48|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689192|NCT01128426|3106862|Superiority or Other|||||||0.67|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689193|NCT01128426|3106862|Superiority or Other|||||||0.92|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689194|NCT01128426|3106862|Superiority or Other|||||||0.58|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689195|NCT01128426|3106862|Superiority or Other|||||||0.29|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689196|NCT01128426|3106862|Superiority or Other|||||||0.76|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689197|NCT01128426|3106862|Superiority or Other|||||||0.71|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689198|NCT01128426|3106862|Superiority or Other|||||||0.32|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689199|NCT01128426|3106862|Superiority or Other|||||||0.48|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689200|NCT01128426|3106862|Superiority or Other|||||||0.51|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689201|NCT01128426|3106862|Superiority or Other|||||||0.71|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689202|NCT01128426|3106862|Superiority or Other|||||||0.96|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689203|NCT01128426|3106862|Superiority or Other|||||||0.95|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689204|NCT01128426|3106862|Superiority or Other|||||||0.51|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689205|NCT01128426|3106862|Superiority or Other|||||||0.87|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689206|NCT01128426|3106862|Superiority or Other|||||||0.39|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689626|NCT01128192|3106908|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes|
1689207|NCT01128426|3106862|Superiority or Other|||||||0.57|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689208|NCT01128426|3106862|Superiority or Other|||||||0.58|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689209|NCT01128426|3106862|Superiority or Other|||||||0.15|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689210|NCT01128426|3106862|Superiority or Other|||||||0.05|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689211|NCT01128426|3106862|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689212|NCT01128426|3106862|Superiority or Other|||||||0.95|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689213|NCT01128426|3106862|Superiority or Other|||||||0.27|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689214|NCT01128426|3106862|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689215|NCT01128426|3106862|Superiority or Other||||||<|0.96|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689216|NCT01128426|3106862|Superiority or Other||||||<|0.22|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689217|NCT01128426|3106862|Superiority or Other||||||<|0.05|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689218|NCT01128426|3106863|Superiority or Other|||||||0.48|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689219|NCT01128426|3106863|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689220|NCT01128426|3106863|Superiority or Other|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689221|NCT01128426|3106863|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689222|NCT01128426|3106863|Superiority or Other|||||||0.7|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689223|NCT01128426|3106863|Superiority or Other|||||||0.57|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689224|NCT01128426|3106863|Superiority or Other|||||||0.48|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689225|NCT01128426|3106863|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689226|NCT01128426|3106863|Superiority or Other|||||||0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689227|NCT01128426|3106863|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689228|NCT01128426|3106863|Superiority or Other|||||||0.48|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689229|NCT01128426|3106863|Superiority or Other|||||||0.54|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689230|NCT01128426|3106863|Superiority or Other|||||||0.34|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689231|NCT01128426|3106863|Superiority or Other|||||||0.38|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689232|NCT01128426|3106863|Superiority or Other|||||||0.27|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689233|NCT01128426|3106863|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689234|NCT01128426|3106863|Superiority or Other||||||<|0.27|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689235|NCT01128426|3106863|Superiority or Other||||||<|0.07|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689236|NCT01128426|3106863|Superiority or Other||||||<|0.48|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689237|NCT01128426|3106863|Superiority or Other||||||<|0.67|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689238|NCT01128426|3106863|Superiority or Other||||||<|0.9|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689239|NCT01128426|3106863|Superiority or Other||||||<|0.33|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689240|NCT01128426|3106863|Superiority or Other||||||<|0.25|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689241|NCT01128426|3106863|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689242|NCT01128426|3106863|Superiority or Other||||||<|0.7|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689243|NCT01128426|3106863|Superiority or Other||||||<|0.13|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689244|NCT01128426|3106863|Superiority or Other||||||<|0.95|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689245|NCT01128426|3106863|Superiority or Other||||||<|0.51|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689246|NCT01128426|3106863|Superiority or Other||||||<|0.41|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689247|NCT01128426|3106863|Superiority or Other||||||<|0.95|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689248|NCT01128426|3106863|Superiority or Other||||||<|0.64|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689249|NCT01128426|3106863|Superiority or Other||||||<|0.84|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689250|NCT01128426|3106863|Superiority or Other||||||<|0.35|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689251|NCT01128426|3106863|Superiority or Other||||||<|0.87|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689252|NCT01128426|3106863|Superiority or Other||||||<|0.48|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689253|NCT01128426|3106863|Superiority or Other||||||<|0.34|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689254|NCT01128426|3106863|Superiority or Other||||||<|0.23|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689255|NCT01128426|3106863|Superiority or Other||||||<|0.95|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689256|NCT01128426|3106863|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689257|NCT01128426|3106863|Superiority or Other||||||<|0.04|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689258|NCT01128426|3106863|Superiority or Other||||||<|0.27|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689259|NCT01128426|3106864|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689260|NCT01128426|3106864|Superiority or Other|||||||0.8|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689261|NCT01128426|3106864|Superiority or Other|||||||0.48|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689262|NCT01128426|3106864|Superiority or Other|||||||0.5|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689263|NCT01128426|3106864|Superiority or Other|||||||0.96|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689264|NCT01128426|3106864|Superiority or Other|||||||0.96|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689265|NCT01128426|3106864|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689266|NCT01128426|3106864|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689267|NCT01128426|3106864|Superiority or Other|||||||0.4|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689268|NCT01128426|3106864|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689269|NCT01128426|3106864|Superiority or Other|||||||0.48|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689270|NCT01128426|3106864|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689271|NCT01128426|3106864|Superiority or Other|||||||0.69|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689272|NCT01128426|3106864|Superiority or Other|||||||0.07|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689273|NCT01128426|3106864|Superiority or Other|||||||0.41|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689274|NCT01128426|3106864|Superiority or Other|||||||0.34|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689275|NCT01128426|3106864|Superiority or Other|||||||0.48|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689276|NCT01128426|3106864|Superiority or Other|||||||0.14|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689277|NCT01128426|3106864|Superiority or Other|||||||0.27|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689278|NCT01128426|3106864|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689279|NCT01128426|3106864|Superiority or Other|||||||0.95|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689280|NCT01128426|3106864|Superiority or Other|||||||0.23|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689281|NCT01128426|3106864|Superiority or Other|||||||0.91|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689282|NCT01128426|3106864|Superiority or Other|||||||0.76|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689283|NCT01128426|3106864|Superiority or Other|||||||0.92|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689284|NCT01128426|3106864|Superiority or Other|||||||0.51|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689285|NCT01128426|3106864|Superiority or Other|||||||0.98|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689286|NCT01128426|3106864|Superiority or Other|||||||0.8|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689287|NCT01128426|3106864|Superiority or Other|||||||0.41|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689288|NCT01128426|3106864|Superiority or Other|||||||0.96|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689289|NCT01128426|3106864|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689290|NCT01128426|3106864|Superiority or Other|||||||0.96|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689291|NCT01128426|3106864|Superiority or Other|||||||0.28|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689292|NCT01128426|3106864|Superiority or Other|||||||0.66|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689293|NCT01128426|3106864|Superiority or Other|||||||0.96|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689294|NCT01128426|3106864|Superiority or Other|||||||0.19|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689295|NCT01128426|3106864|Superiority or Other|||||||0.23|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689296|NCT01128426|3106864|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689297|NCT01128426|3106864|Superiority or Other|||||||0.27|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689298|NCT01128426|3106864|Superiority or Other|||||||0.33|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689299|NCT01128426|3106864|Superiority or Other|||||||0.96|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689300|NCT01128426|3106864|Superiority or Other|||||||0.87|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689301|NCT01128426|3106864|Superiority or Other|||||||0.15|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689302|NCT01128426|3106865|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689303|NCT01128426|3106865|Superiority or Other|||||||0.27|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689304|NCT01128426|3106865|Superiority or Other|||||||0.05|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689305|NCT01128426|3106865|Superiority or Other|||||||0.14|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689306|NCT01128426|3106865|Superiority or Other|||||||0.91|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689307|NCT01128426|3106865|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689308|NCT01128426|3106865|Superiority or Other||||||<|0.08|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689309|NCT01128426|3106865|Superiority or Other||||||<|0.08|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689310|NCT01128426|3106865|Superiority or Other||||||<|0.1|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689311|NCT01128426|3106865|Superiority or Other||||||<|0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689312|NCT01128426|3106865|Superiority or Other||||||<|0.65|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689313|NCT01128426|3106865|Superiority or Other||||||<|0.67|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689314|NCT01128426|3106865|Superiority or Other||||||<|0.14|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689315|NCT01128426|3106865|Superiority or Other||||||<|0.13|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689316|NCT01128426|3106865|Superiority or Other||||||<|0.96|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689317|NCT01128426|3106865|Superiority or Other||||||<|0.04|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689318|NCT01128426|3106865|Superiority or Other||||||<|0.06|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689319|NCT01128426|3106865|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689320|NCT01128426|3106865|Superiority or Other||||||<|0.14|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689321|NCT01128426|3106865|Superiority or Other||||||<|0.15|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689322|NCT01128426|3106865|Superiority or Other||||||<|0.68|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689323|NCT01128426|3106865|Superiority or Other||||||<|0.08|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689324|NCT01128426|3106865|Superiority or Other||||||<|0.14|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689325|NCT01128426|3106865|Superiority or Other||||||<|0.15|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689326|NCT01128426|3106865|Superiority or Other||||||<|0.57|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689327|NCT01128426|3106865|Superiority or Other||||||<|0.27|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689328|NCT01128426|3106865|Superiority or Other||||||<|0.95|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689329|NCT01128426|3106865|Superiority or Other||||||<|0.48|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689330|NCT01128426|3106865|Superiority or Other||||||<|0.33|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689331|NCT01128426|3106865|Superiority or Other||||||<|0.4|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689332|NCT01128426|3106865|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689333|NCT01128426|3106865|Superiority or Other||||||<|0.19|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689334|NCT01128426|3106865|Superiority or Other||||||<|0.16|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689335|NCT01128426|3106865|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689336|NCT01128426|3106865|Superiority or Other||||||<|1|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689337|NCT01128426|3106865|Superiority or Other||||||<|0.11|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689338|NCT01128426|3106865|Superiority or Other||||||<|0.29|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689339|NCT01128426|3106865|Superiority or Other||||||<|0.42|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689340|NCT01128426|3106865|Superiority or Other||||||<|0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689341|NCT01128426|3106865|Superiority or Other||||||<|0.35|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689342|NCT01128426|3106865|Superiority or Other||||||<|0.68|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689343|NCT01128426|3106865|Superiority or Other||||||<|0.18|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689344|NCT01128426|3106865|Superiority or Other||||||<|0.19|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689345|NCT01128426|3106865|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689346|NCT01128426|3106865|Superiority or Other||||||<|0.06|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689347|NCT01128426|3106865|Superiority or Other||||||<|0.1|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689348|NCT01128426|3106865|Superiority or Other||||||<|0.02|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689349|NCT01128426|3106865|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689350|NCT01128426|3106865|Superiority or Other||||||<|0.86|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689351|NCT01128426|3106865|Superiority or Other||||||<|0.28|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689352|NCT01128426|3106865|Superiority or Other||||||<|0.95|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689353|NCT01128426|3106865|Superiority or Other||||||<|0.02|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689354|NCT01128426|3106865|Superiority or Other||||||<|0.59|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689355|NCT01128426|3106866|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689356|NCT01128426|3106866|Superiority or Other|||||||0.52|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689357|NCT01128426|3106866|Superiority or Other|||||||0.03|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689358|NCT01128426|3106866|Superiority or Other|||||||0.14|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689359|NCT01128426|3106866|Superiority or Other|||||||0.91|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689360|NCT01128426|3106866|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689361|NCT01128426|3106866|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689362|NCT01128426|3106866|Superiority or Other||||||<|0.68|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689627|NCT01128192|3106909|Superiority or Other|||||||0.339||||||Two sided P value.|ANOVA|||Change in fasting plasma glucose level|
1689363|NCT01128426|3106866|Superiority or Other||||||<|0.27|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689364|NCT01128426|3106866|Superiority or Other||||||<|0.48|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689365|NCT01128426|3106866|Superiority or Other||||||<|0.87|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689366|NCT01128426|3106866|Superiority or Other||||||<|0.09|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689367|NCT01128426|3106866|Superiority or Other||||||<|0.92|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689368|NCT01128426|3106866|Superiority or Other||||||<|0.12|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689369|NCT01128426|3106866|Superiority or Other||||||<|0.48|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689370|NCT01128426|3106866|Superiority or Other||||||<|0.23|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689371|NCT01128426|3106866|Superiority or Other||||||<|0.68|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689372|NCT01128426|3106866|Superiority or Other||||||<|0.17|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689373|NCT01128426|3106866|Superiority or Other||||||<|0.95|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689374|NCT01128426|3106866|Superiority or Other||||||<|0.48|||||||mid-p exact binomial method|||Hand, foot and mouth disease: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689375|NCT01128426|3106866|Superiority or Other||||||<|0.66|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689376|NCT01128426|3106866|Superiority or Other||||||<|0.45|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689377|NCT01128426|3106866|Superiority or Other||||||<|0.02|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689378|NCT01128426|3106866|Superiority or Other||||||<|0.27|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689379|NCT01128426|3106866|Superiority or Other||||||<|0.3|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689380|NCT01128426|3106866|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689381|NCT01128426|3106866|Superiority or Other||||||<|0.35|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689382|NCT01128426|3106866|Superiority or Other||||||<|0.14|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689383|NCT01128426|3106866|Superiority or Other||||||<|0.51|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689384|NCT01128426|3106866|Superiority or Other||||||<|0.68|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689385|NCT01128426|3106866|Superiority or Other||||||<|0.35|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689386|NCT01128426|3106866|Superiority or Other||||||<|0.95|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689387|NCT01128426|3106866|Superiority or Other||||||<|0.05|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689388|NCT01128426|3106866|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689389|NCT01128426|3106866|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689390|NCT01128426|3106866|Superiority or Other||||||<|0.11|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689391|NCT01128426|3106866|Superiority or Other||||||<|0.14|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689392|NCT01128426|3106866|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689393|NCT01128426|3106866|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689394|NCT01128426|3106866|Superiority or Other||||||<|0.15|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689395|NCT01128426|3106866|Superiority or Other||||||<|0.49|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689396|NCT01128426|3106866|Superiority or Other||||||<|0.62|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689397|NCT01128426|3106867|Superiority or Other|||||||0.27|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689398|NCT01128426|3106867|Superiority or Other|||||||0.92|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689399|NCT01128426|3106867|Superiority or Other|||||||0.34|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689400|NCT01128426|3106867|Superiority or Other|||||||0.09|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689401|NCT01128426|3106867|Superiority or Other|||||||0.08|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689402|NCT01128426|3106867|Superiority or Other|||||||0.11|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689403|NCT01128426|3106867|Superiority or Other|||||||0.9|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689404|NCT01128426|3106867|Superiority or Other|||||||0.38|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689405|NCT01128426|3106867|Superiority or Other|||||||0.14|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689406|NCT01128426|3106867|Superiority or Other|||||||0.95|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689407|NCT01128426|3106867|Superiority or Other|||||||0.93|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689408|NCT01128426|3106867|Superiority or Other|||||||0.04|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689409|NCT01128426|3106867|Superiority or Other|||||||0.88|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689410|NCT01128426|3106867|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689411|NCT01128426|3106867|Superiority or Other||||||<|0.14|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689412|NCT01128426|3106867|Superiority or Other||||||<|0.46|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689413|NCT01128426|3106867|Superiority or Other||||||<|0.08|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689414|NCT01128426|3106867|Superiority or Other||||||<|0.48|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689415|NCT01128426|3106867|Superiority or Other||||||<|0.15|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689416|NCT01128426|3106867|Superiority or Other||||||<|0.57|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689417|NCT01128426|3106867|Superiority or Other||||||<|0.27|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689418|NCT01128426|3106867|Superiority or Other||||||<|0.23|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689419|NCT01128426|3106867|Superiority or Other||||||<|0.42|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689420|NCT01128426|3106867|Superiority or Other||||||<|0.14|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689421|NCT01128426|3106867|Superiority or Other||||||<|0.25|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689422|NCT01128426|3106867|Superiority or Other||||||<|0.24|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689423|NCT01128426|3106867|Superiority or Other||||||<|0.57|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689424|NCT01128426|3106867|Superiority or Other||||||<|0.79|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689425|NCT01128426|3106867|Superiority or Other||||||<|0.88|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1690632|NCT01118273|3108527|Superiority or Other|||||||0.25|||||||ANCOVA||||
1689426|NCT01128426|3106867|Superiority or Other||||||<|0.33|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689427|NCT01128426|3106867|Superiority or Other||||||<|0.42|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689428|NCT01128426|3106867|Superiority or Other||||||<|0.05|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689429|NCT01128426|3106867|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689430|NCT01128426|3106867|Superiority or Other||||||<|0.27|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689431|NCT01128426|3106867|Superiority or Other||||||<|0.04|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689432|NCT01128426|3106867|Superiority or Other||||||<|0.11|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689433|NCT01128426|3106867|Superiority or Other||||||<|0.13|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689434|NCT01128426|3106867|Superiority or Other||||||<|0.02|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689435|NCT01128426|3106867|Superiority or Other||||||<|0.86|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689436|NCT01128426|3106867|Superiority or Other||||||<|0.91|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689437|NCT01128426|3106867|Superiority or Other||||||<|0.95|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689438|NCT01128426|3106867|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689439|NCT01128426|3106867|Superiority or Other||||||<|0.14|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689440|NCT01128426|3106868|Superiority or Other|||||||0.77|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689441|NCT01128426|3106868|Superiority or Other|||||||0.99|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689442|NCT01128426|3106868|Superiority or Other|||||||0.09|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689443|NCT01128426|3106868|Superiority or Other|||||||0.13|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689444|NCT01128426|3106868|Superiority or Other|||||||0.13|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689445|NCT01128426|3106868|Superiority or Other|||||||0.02|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689446|NCT01128426|3106868|Superiority or Other|||||||0.85|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689447|NCT01128426|3106868|Superiority or Other|||||||0.23|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689448|NCT01128426|3106868|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689449|NCT01128426|3106868|Superiority or Other||||||<|0.63|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689450|NCT01128426|3106868|Superiority or Other||||||<|0.26|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689451|NCT01128426|3106868|Superiority or Other||||||<|0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689452|NCT01128426|3106868|Superiority or Other||||||<|0.97|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689453|NCT01128426|3106868|Superiority or Other||||||<|0.71|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689454|NCT01128426|3106868|Superiority or Other||||||<|0.38|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689455|NCT01128426|3106868|Superiority or Other||||||<|0.05|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689456|NCT01128426|3106868|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689457|NCT01128426|3106868|Superiority or Other||||||<|0.33|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689458|NCT01128426|3106868|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689459|NCT01128426|3106868|Superiority or Other||||||<|0.61|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689460|NCT01128426|3106868|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689461|NCT01128426|3106868|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689462|NCT01128426|3106868|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689463|NCT01128426|3106868|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689464|NCT01128426|3106868|Superiority or Other||||||<|0.77|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689465|NCT01128426|3106868|Superiority or Other||||||<|0.5|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689466|NCT01128426|3106868|Superiority or Other||||||<|0.67|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689467|NCT01128426|3106868|Superiority or Other||||||<|0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689468|NCT01128426|3106868|Superiority or Other||||||<|0.13|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689469|NCT01128426|3106868|Superiority or Other||||||<|0.02|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689470|NCT01128426|3106868|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689471|NCT01128426|3106868|Superiority or Other||||||<|0.71|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689472|NCT01128426|3106868|Superiority or Other||||||<|0.33|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689473|NCT01128426|3106868|Superiority or Other||||||<|0.04|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689474|NCT01128426|3106868|Superiority or Other||||||<|0.03|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689475|NCT01128426|3106868|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689476|NCT01128426|3106868|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689477|NCT01128426|3106868|Superiority or Other||||||<|0.98|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689478|NCT01128426|3106868|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689479|NCT01128426|3106868|Superiority or Other||||||<|0.36|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689480|NCT01128426|3106868|Superiority or Other||||||<|0.67|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689481|NCT01128426|3106868|Superiority or Other||||||<|0.07|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689482|NCT01128426|3106868|Superiority or Other||||||<|0.4|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689483|NCT01128426|3106868|Superiority or Other||||||<|0.5|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689484|NCT01128426|3106868|Superiority or Other||||||<|0.03|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689485|NCT01128426|3106868|Superiority or Other||||||<|0.09|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689486|NCT01128426|3106868|Superiority or Other||||||<|0.79|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689487|NCT01128426|3106868|Superiority or Other||||||<|0.99|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689628|NCT01128192|3106909|Superiority or Other|||||||0.24||||||Two sided P value|ANOVA|||Change in fasting plasma glucose level|
1689488|NCT01128426|3106868|Superiority or Other||||||<|0.2|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689489|NCT01128426|3106868|Superiority or Other||||||<|0.63|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689490|NCT01128426|3106868|Superiority or Other||||||<|0.99|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689491|NCT01128426|3106868|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689492|NCT01128426|3106868|Superiority or Other||||||<|0.77|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689493|NCT01128426|3106869|Superiority or Other|||||||0.77|||||||mid-p exact binomial method|||Wheezing: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689494|NCT01128426|3106869|Superiority or Other|||||||0.62|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689495|NCT01128426|3106869|Superiority or Other|||||||0.53|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689496|NCT01128426|3106869|Superiority or Other|||||||0.13|||||||mid-p exact binomial method|||Vaccines adverse reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689497|NCT01128426|3106869|Superiority or Other|||||||0.13|||||||mid-p exact binomial method|||Urticaria: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689498|NCT01128426|3106869|Superiority or Other|||||||0.66|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689499|NCT01128426|3106869|Superiority or Other|||||||0.74|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689500|NCT01128426|3106869|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689501|NCT01128426|3106869|Superiority or Other||||||<|0.63|||||||mid-p exact binomial method|||Subconjunctival hemorrhage: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689502|NCT01128426|3106869|Superiority or Other||||||<|0.06|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689503|NCT01128426|3106869|Superiority or Other||||||<|0.5|||||||mid-p exact binomial method|||Stomatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689504|NCT01128426|3106869|Superiority or Other||||||<|0.98|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689505|NCT01128426|3106869|Superiority or Other||||||<|0.83|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689506|NCT01128426|3106869|Superiority or Other||||||<|0.26|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689507|NCT01128426|3106869|Superiority or Other||||||<|0.12|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689508|NCT01128426|3106869|Superiority or Other||||||<|0.83|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689509|NCT01128426|3106869|Superiority or Other||||||<|0.12|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689510|NCT01128426|3106869|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689511|NCT01128426|3106869|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689512|NCT01128426|3106869|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689513|NCT01128426|3106869|Superiority or Other||||||<|0.5|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689514|NCT01128426|3106869|Superiority or Other||||||<|0.99|||||||mid-p exact binomial method|||Hematoma: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689515|NCT01128426|3106869|Superiority or Other||||||<|0.75|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689516|NCT01128426|3106869|Superiority or Other||||||<|0.04|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689517|NCT01128426|3106869|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689518|NCT01128426|3106869|Superiority or Other||||||<|0.63|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689519|NCT01128426|3106869|Superiority or Other||||||<|0.41|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689520|NCT01128426|3106869|Superiority or Other||||||<|0.07|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689521|NCT01128426|3106869|Superiority or Other||||||<|0.77|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689522|NCT01128426|3106869|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689523|NCT01128426|3106869|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689524|NCT01128426|3106869|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689525|NCT01128426|3106869|Superiority or Other||||||<|0.19|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689526|NCT01128426|3106869|Superiority or Other||||||<|0.37|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689527|NCT01128426|3106869|Superiority or Other||||||<|0.36|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689528|NCT01128426|3106869|Superiority or Other||||||<|0.71|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689529|NCT01128426|3106869|Superiority or Other||||||<|0.5|||||||mid-p exact binomial method|||Asthma with acute exacerbation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689530|NCT01128426|3106869|Superiority or Other||||||<|0.42|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689531|NCT01128426|3106869|Superiority or Other||||||<|0.61|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689532|NCT01128426|3106869|Superiority or Other||||||<|0.5|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689533|NCT01128426|3106869|Superiority or Other||||||<|0.99|||||||mid-p exact binomial method|||Adverse drug reaction: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689534|NCT01128426|3106869|Superiority or Other||||||<|0.5|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689535|NCT01128426|3106869|Superiority or Other||||||<|0.04|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689536|NCT01128426|3106869|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689537|NCT01128426|3106869|Superiority or Other||||||<|0.63|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689538|NCT01128426|3106870|Superiority or Other|||||||0.25|||||||mid-p exact binomial method|||Weakness: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689539|NCT01128426|3106870|Superiority or Other|||||||0.04|||||||mid-p exact binomial method|||Viral syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689540|NCT01128426|3106870|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Urinary tract infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689541|NCT01128426|3106870|Superiority or Other||||||<|0.79|||||||mid-p exact binomial method|||Unspecified septicemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689542|NCT01128426|3106870|Superiority or Other||||||<|0.23|||||||mid-p exact binomial method|||Unspecified bacterial pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689543|NCT01128426|3106870|Superiority or Other||||||<|0.05|||||||mid-p exact binomial method|||Umbilical hernia without obstruction/gangrene: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689544|NCT01128426|3106870|Superiority or Other||||||<|0.74|||||||mid-p exact binomial method|||Stridor: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689545|NCT01128426|3106870|Superiority or Other||||||<|0.83|||||||mid-p exact binomial method|||Single seizure: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689546|NCT01128426|3106870|Superiority or Other||||||<|0.71|||||||mid-p exact binomial method|||Retinopathy of prematurity stage 2: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689547|NCT01128426|3106870|Superiority or Other||||||<|0.02|||||||mid-p exact binomial method|||Respiratory syncytial virus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689548|NCT01128426|3106870|Superiority or Other||||||<|0.04|||||||mid-p exact binomial method|||Rash: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689549|NCT01128426|3106870|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Primary apnea of newborn: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1690283|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-12.454|||||2-Sided|95.0|-27.78|2.88|||||Day 14, 24 Hours||
1689550|NCT01128426|3106870|Superiority or Other||||||<|0.09|||||||mid-p exact binomial method|||Pneumonia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689551|NCT01128426|3106870|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Pilonidal cyst without mention of abscess: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689552|NCT01128426|3106870|Superiority or Other||||||<|0.98|||||||mid-p exact binomial method|||Other specified cardiac dysrhythmias: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689553|NCT01128426|3106870|Superiority or Other||||||<|0.26|||||||mid-p exact binomial method|||Other diseases of nasal cavity and sinuses: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689554|NCT01128426|3106870|Superiority or Other||||||<|0.03|||||||mid-p exact binomial method|||Neonatal candida infection: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689555|NCT01128426|3106870|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Neonatal bradycardia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689556|NCT01128426|3106870|Superiority or Other||||||<|0.5|||||||mid-p exact binomial method|||Nausea and vomiting: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689557|NCT01128426|3106870|Superiority or Other||||||<|0.52|||||||mid-p exact binomial method|||Methicillin susceptible Staphylococcus aureus: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689558|NCT01128426|3106870|Superiority or Other||||||<|0.5|||||||mid-p exact binomial method|||Lipoma of other specified sites: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689559|NCT01128426|3106870|Superiority or Other||||||<|0.67|||||||mid-p exact binomial method|||Hypopotassemia: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689560|NCT01128426|3106870|Superiority or Other||||||<|0.03|||||||mid-p exact binomial method|||Gastroenteritis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689561|NCT01128426|3106870|Superiority or Other||||||<|0.33|||||||mid-p exact binomial method|||Fussy infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689562|NCT01128426|3106870|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Fever: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689563|NCT01128426|3106870|Superiority or Other||||||<|0.7|||||||mid-p exact binomial method|||Failure to thrive: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689564|NCT01128426|3106870|Superiority or Other||||||<|0.38|||||||mid-p exact binomial method|||Dyspnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689565|NCT01128426|3106870|Superiority or Other||||||<|0.21|||||||mid-p exact binomial method|||Dermatitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689566|NCT01128426|3106870|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Dehydration: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689567|NCT01128426|3106870|Superiority or Other||||||<|0.03|||||||mid-p exact binomial method|||Croup: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689568|NCT01128426|3106870|Superiority or Other||||||<|0.21|||||||mid-p exact binomial method|||Constipation: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689569|NCT01128426|3106870|Superiority or Other||||||<|0.98|||||||mid-p exact binomial method|||Cellulitis and abscess of trunk: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689570|NCT01128426|3106870|Superiority or Other||||||<|0.18|||||||mid-p exact binomial method|||Candidiasis of mouth: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689571|NCT01128426|3106870|Superiority or Other||||||<|0.5|||||||mid-p exact binomial method|||Bronchospasm: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689572|NCT01128426|3106870|Superiority or Other||||||<|0.5|||||||mid-p exact binomial method|||Bronchitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689573|NCT01128426|3106870|Superiority or Other||||||<|0.05|||||||mid-p exact binomial method|||Bronchiolitis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689574|NCT01128426|3106870|Superiority or Other||||||<|0.03|||||||mid-p exact binomial method|||Asthma, unspecified, unspecified status: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689575|NCT01128426|3106870|Superiority or Other||||||<|0.03|||||||mid-p exact binomial method|||Apparent life threatening event infant: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689576|NCT01128426|3106870|Superiority or Other||||||<|0.16|||||||mid-p exact binomial method|||Apnea: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689577|NCT01128426|3106870|Superiority or Other||||||<|0.79|||||||mid-p exact binomial method|||Alkalosis: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689578|NCT01128426|3106870|Superiority or Other||||||<|0.2|||||||mid-p exact binomial method|||Acute pyelonephritis without RMN lesion: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689579|NCT01128426|3106870|Superiority or Other||||||<|0.05|||||||mid-p exact binomial method|||Acute otitis media: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689580|NCT01128426|3106870|Superiority or Other||||||<|0.99|||||||mid-p exact binomial method|||Acute febrile mucocutaneous lymph node syndrome: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1690633|NCT01118273|3108528|Superiority or Other|||||||0.59|||||||ANCOVA||||
1689581|NCT01128426|3106870|Superiority or Other||||||<|0.01|||||||mid-p exact binomial method|||Acute bronchiolitis due to RSV: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689582|NCT01128426|3106870|Superiority or Other||||||<|0.98|||||||mid-p exact binomial method|||Abnormal involuntary movements: p-value was estimated using the mid-p exact binomial method. The null hypothesis was relative risk = 1.|
1689583|NCT01128400|3106872|Superiority or Other|||||||0.05|||||||ANOVA||||
1689584|NCT01128400|3106873|Superiority or Other|||||||0.05|||||||ANOVA||||
1689585|NCT01128387|3106875|Other||Maximum Tolerated Dose|750.0|||||2-Sided|||||||||Dose of Fluorourcil|
1689586|NCT01128387|3106875|Other||Maximum Tolerated Dose|60.0|||||2-Sided|||||||||Dose of Cisplatin|
1689587|NCT01128387|3106875|Other||Maximum Tolerated Dose|1.5|||||2-Sided|||||||||Dose of Pantiumumab (in combination with Cisplatin & Fluorouracil - see below)|
1689588|NCT01128270|3106891|Superiority or Other||Mean|0.38|Standard Deviation|0.17|||2-Sided|95.0|0.24|0.51||||||Only relevant for arm 2B|
1689589|NCT01128270|3106892|Superiority or Other||Mean Difference (Net)|2432.0|Standard Deviation|1403.0||0.0017|2-Sided|95.0|1260.0|3606.0|||t-test, 2 sided|||Only relevant to Arm 2B.|
1689590|NCT01128270|3106893|Superiority or Other||Mean of one group (2A)|1.64|Standard Deviation|0.4|||2-Sided|95.0|1.31|1.97|||||Only arm 2A is relevant to this variable. There is no intended statistical comparison, but the point estimate for the mean level and 95% confidence interval are provided.|No comparison is relevant. The statistical method is how we obtained the point estimate and confidence interval. No test was intended.|
1689591|NCT01128244|3106894|Superiority or Other||Test of treatment effect.|0.05|||<|0.05|2-Sided|||||Data were analyzed by paired t-test adjusted for multiple testing by Sidak methods.|t-test, 2 sided|||Data were analyzed by paired t-test adjusted for multiple testing by Sidak methods.|
1689592|NCT01128244|3106895|Superiority or Other|||||||0.45||||||Threshold for significance, P<0.05|t-test, 2 sided|Paired t-test|||
1689593|NCT01128244|3106896|Superiority or Other||||||<|0.001||||||Threshold for significance, P<0.05|t-test, 2 sided|Paired t-test|||
1689594|NCT01128244|3106897|Superiority or Other|||||||0.62||||||Threshold for significance, P<0.05|t-test, 2 sided|Paired t-test|||
1689595|NCT01128244|3106898|Superiority or Other|||||||0.2||||||Threshold for significance P<0.05|t-test, 2 sided|Paired t-test|||
1689596|NCT01128192|3106899|Superiority or Other|||||||0.956||||||Two sided P value.|ANOVA|||Change in High-Dose Glucose Disposal Rate (GDR)|
1689597|NCT01128192|3106899|Superiority or Other|||||||0.993||||||Two sided P value.|ANOVA|||Change in High-Dose Glucose Disposal Rate (GDR)|
1689598|NCT01128192|3106900|Superiority or Other|||||||0.125||||||Two sided P value.|ANOVA|||Change in Low-Dose Glucose Disposal Rate (GDR)|
1689599|NCT01128192|3106900|Superiority or Other|||||||0.956||||||Two sided P value.|ANOVA|||Change in Low-Dose Glucose Disposal Rate (GDR)|
1689600|NCT01128192|3106901|Superiority or Other|||||||0.573||||||Two sided P value.|ANOVA|||Change in high-dose % EGP Inhibition|
1689601|NCT01128192|3106902|Superiority or Other|||||||0.111||||||Two sided P value.|ANOVA|||Change in Low-Dose % EGP Inhibition|
1689602|NCT01128192|3106902|Superiority or Other|||||||0.178||||||Two sided P value.|ANOVA|||Change in Low-Dose % EGP Inhibition|
1689603|NCT01128192|3106903|Superiority or Other|||||||0.132||||||Two sided P value.|ANOVA|||Change in Basal EGP|
1689604|NCT01128192|3106903|Superiority or Other|||||||0.608||||||Two sided P value.|ANOVA|||Change in Basal EGP|
1689605|NCT01128192|3106904|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes|
1689606|NCT01128192|3106904|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes|
1689607|NCT01128192|3106904|Superiority or Other||||||<|0.001||||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes|
1689608|NCT01128192|3106904|Superiority or Other||||||<|0.001||||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes|
1689609|NCT01128192|3106904|Superiority or Other||||||<|0.001||||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 10-180 minutes|
1689610|NCT01128192|3106904|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-10 minutes|
1689611|NCT01128192|3106905|Superiority or Other||||||<|0.001||||||Two sided P value|ANOVA|||Change in Baseline Insulin Level|
1689612|NCT01128192|3106905|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Change in Baseline Insulin Level|
1689613|NCT01128192|3106906|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes|
1689614|NCT01128192|3106906|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes|
1689615|NCT01128192|3106906|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes|
1689616|NCT01128192|3106906|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes|
1689617|NCT01128192|3106906|Superiority or Other||||||<|0.001||||||Two sided P value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes|
1689618|NCT01128192|3106906|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes|
1689619|NCT01128192|3106907|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Change in fasting plasma insulin level|
1689620|NCT01128192|3106907|Superiority or Other||||||<|0.019||||||Two sided P value.|ANOVA|||Change in fasting plasma insulin level|
1689621|NCT01128192|3106908|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes|
1689622|NCT01128192|3106908|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 30-180 minutes|
1689623|NCT01128192|3106908|Superiority or Other||||||<|0.001||||||Two sided P value.|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-30 minutes|
1689624|NCT01128192|3106908|Superiority or Other||||||<|0.001||||||Two sided P Value|ANOVA|||Pre and Post treatment Area Under the Curve (AUC) 0-180 minutes|
1689629|NCT01128179|3106910|Superiority or Other||Mean Difference (Final Values)|-0.0129||||0.922|2-Sided|95.0|-0.2811|0.2553||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Calcium-Phosphate Product at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Calcium-Phosphate Product as a covariate.|
1689630|NCT01128179|3106911|Superiority or Other||Mean Difference (Final Values)|0.0294||||0.5636|2-Sided|95.0|-0.0739|0.1328||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||"The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Total Calcium at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Total Calcium as a covariate.~The study was not powered for the analysis of this parameter."|
1689631|NCT01128179|3106912|Superiority or Other||Mean Difference (Final Values)|-0.0297||||0.6134|2-Sided|95.0|-0.1492|0.0897||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||"The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Phosphate at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Phosphate as a covariate.~The study was not powered for the analysis of this parameter"|
1689632|NCT01128179|3106913|Superiority or Other||Mean Difference (Final Values)|-3.7||||0.1459|2-Sided|95.0|-8.845|1.403||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||"The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Urinary Fractional Excretion of Phosphate at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Urinary Fractional Excretion of Phosphate as a covariate.~The study was not powered for the analysis of this parameter."|
1689633|NCT01128179|3106914|Superiority or Other||Mean Difference (Final Values)|5.11||||0.3252|2-Sided|95.0|-5.36|15.57||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||"The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of 1,25-Dihydroxy Vitamin D at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline 1,25-Dihydroxy Vitamin D as a covariate.~The study was not powered for the analysis of this parameter."|
1689634|NCT01128179|3106915|Superiority or Other||Mean Difference (Final Values)|6.54||||0.2995|2-Sided|95.0|-6.15|19.23||The p-value was unadjusted and had no a priori significance level.|ANCOVA|||"The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of serum iPTH at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline iPTH as a covariate.~The study was not powered for the analysis of this parameter."|
1689635|NCT01128179|3106916|Superiority or Other||Mean Difference (Final Values)|-0.1121||||0.3186|2-Sided|95.0|-0.3389|0.1146||The a priori significance level was 5%. There was no adjustment for multiple comparisons.|ANCOVA|||Assuming that the natural logarithm transformed serum intact FGF-23 is normally distributed with a mean of 3.5 and a standard deviation of 0.46, 33 subjects randomised 2:1 (lanthanum carbonate to placebo) will be sufficient to detect with 80% power at the 5% 2-sided significance level a decrease of 0.5 in the mean difference (placebo minus lanthanum carbonate) of the log-transformed data at Week 12.|
1689636|NCT01128153|3106917|Superiority or Other||Odds Ratio (OR)|9.006|||<|0.0001|2-Sided|95.0|3.852|21.05|||ANCOVA||Estimated Odds Ratio from the logistic regression model (Saxa/Placebo)||
1689637|NCT01128153|3106918|Superiority or Other||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|0.255||0.0868|2-Sided|95.0|-0.94|0.06|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin – Placebo)||
1689638|NCT01128153|3106919|Superiority or Other||Mean Difference (Final Values)|-7.9|Standard Error of the Mean|4.595||0.0868|2-Sided|95.0|-16.96|1.15|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin – Placebo)||
1689639|NCT01128153|3106920|Superiority or Other||Mean Difference (Final Values)|-0.93|Standard Error of the Mean|0.426||0.0301|2-Sided|95.0|-1.77|-0.09|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin – Placebo)||
1689640|NCT01128153|3106921|Superiority or Other||Mean Difference (Final Values)|-16.74|Standard Error of the Mean|7.667||0.0301|2-Sided|95.0|-31.85|-1.62|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin – Placebo)||
1689641|NCT01128153|3106922|Superiority or Other||Mean Difference (Final Values)|-0.66|Standard Error of the Mean|0.099|<|0.0001|2-Sided|95.0|-0.86|-0.47|||ANCOVA||Adjusted mean treatment difference from the ANCOVA model (Saxagliptin – Placebo)||
1689642|NCT01127633|3106961|Non-Inferiority or Equivalence (legacy)|The noninferiority margin for this hypothesis was specified as 50% of the treatment difference observed at the end of the feeder study. If the lower limit of the confidence interval (CI) was greater than 0, the noninferiority criterion was met, indicating that at least 50% of the treatment difference observed at the end of the feeder studies was maintained at specified time points in the delayed-start period.|Median Difference (Net)|-0.02||||0.974|2-Sided|95.0|-1.14|1.11|||Mixed Models Analysis||||
1689643|NCT01127581|3106991|Superiority or Other||Difference in Proportions|1.68|||<|0.001|2-Sided|95.0|||||Fisher Exact||MVI 200 - DVI||
1689644|NCT01127581|3106992|Superiority or Other||Difference in Proportions|29.8|||<|0.001|2-Sided|95.0|||||Fisher Exact||MVI 200 - DVI||
1689645|NCT01127581|3106993|Superiority or Other||Difference in Proportions|13.9|||<|0.001|2-Sided|95.0|||||Fisher Exact||MVI 200 - DVI||
1689646|NCT01127581|3106994|Superiority or Other||Difference in Proportions|26.96|||<|0.001|2-Sided|95.0|||||Fisher Exact||MVI 200 - DVI||
1689647|NCT01127581|3106995|Superiority or Other||Difference in Proportions|9.67|||<|0.001|2-Sided|95.0|||||Fisher Exact||MVI 200 - DVI||
1689648|NCT01127581|3106996|Superiority or Other||Difference in Proportions|-26.0|||<|0.001|2-Sided|95.0|||||Fisher Exact||MVI 200 - DVI||
1689649|NCT01127581|3106997|Superiority or Other||Median Difference (Net)|-390.0|||<|0.001|2-Sided|95.0|||||Log Rank||MVI 200 - DVI|Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.|
1689650|NCT01127581|3106998|Superiority or Other||Median Difference (Net)|-543.0|||<|0.001|2-Sided|95.0|||||Log Rank||MVI 200 - DVI|Subjects who did not deliver during the first hospitalization were censored using the longest time interval from study drug administration to labor and delivery discharge without delivery, independent of treatment group.|
1689651|NCT01127581|3106999|Non-Inferiority or Equivalence|A sample size of 675 subjects per group will provide a sufficient number of subjects to assess non-inferiority of MVI 200 with respect to rate of cesarean delivery, based on an alpha level of 5% and 80% power for a two-sided approach using a 10% non-inferiority limit (relative to the DVI rate), assuming a 30% rate of cesarean delivery in the DVI group compared to a 26% rate in the MVI 200 group.|Difference in Populations|-1.1|||||2-Sided|95.0|-5.79|3.59|||||MVI 200 - DVI|The analysis of the cesarean delivery rates during the first hospitalization was based on a between-treatment-group difference. If the upper limit of the asymptotic two-sided 95% confidence interval of the difference in event rates (MVI minus DVI) was less than the calculated non-inferiority margin (10% relative to the DVI rate, i.e., 0.1 times DVI rate), then MVI 200 would be considered non-inferior to DVI.|
1689652|NCT01127581|3107000|Superiority or Other||Median Difference (Net)|-677.0|||<|0.001|2-Sided|95.0|||||Log Rank||Sample size 675 per group provides 90% power to see an improvement of ≥320 minutes (20% improvement from DVI) in time to vaginal delivery between MVI 200 & DVI assuming a median time of 1600 minutes for DVI & 34% dropout rate based on 5% 2‑sided test|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.|
1689653|NCT01127087|3107024|Superiority or Other|||||||0.06|||||||t-test, 2 sided|||Comparison of Oxalate before and at the end of 4 weeks on Oxazyme in the Idiopathic Hyperoxaluria CaOx Stone Formers arm.|
1689654|NCT01127087|3107024|Superiority or Other|||||||0.018|||||||t-test, 2 sided|||Comparison of Oxalate before and at the end of 4 weeks on Oxazyme in the RYGB CaOx Stone Formers arm.|
1689655|NCT01127087|3107025|Superiority or Other|||||||0.14|||||||t-test, 2 sided|||Comparison of Urinary oxalate before and at the end of 4 weeks on Oxazyme in the Idiopathic Hyperoxaluria CaOx Stone Formers arm.|
1689656|NCT01127087|3107025|Superiority or Other|||||||0.027|||||||t-test, 2 sided|||Comparison of Urinary oxalate before and at the end of 4 weeks on Oxazyme in the RYGB Calcium oxalate (CaOx) Stone Formers arm.|
1689657|NCT01126723|3107047|Superiority or Other|||||||0.15||||||The a priori threshold for statistical significance was set to 0.05.|Fisher Exact||||
1689658|NCT01126580|3107083|Superiority or Other|||||||0.004||||||Treatment comparison of HOMA2-%S at 52 weeks.|Mixed Models Analysis||||
1689659|NCT01126580|3107083|Superiority or Other|||||||0.077||||||Treatment comparison of HOMA2-%S at 52 weeks.|Mixed Models Analysis||||
1689660|NCT01126580|3107083|Superiority or Other|||||||0.01||||||Treatment comparison of HOMA2-%S at 26 weeks.|Mixed Models Analysis||||
1689661|NCT01126580|3107083|Superiority or Other|||||||0.001||||||Treatment comparison of HOMA2-%S at 26 weeks.|Mixed Models Analysis||||
1689662|NCT01126580|3107083|Superiority or Other|||||||0.003||||||Treatment comparison of HOMA2-%B at 52 weeks.|Mixed Models Analysis||||
1689663|NCT01126580|3107083|Superiority or Other||||||<|0.001||||||Treatment comparison of HOMA2-%B at 52 weeks.|Mixed Models Analysis||||
1689664|NCT01126580|3107083|Superiority or Other||||||<|0.001||||||Treatment comparison of HOMA2-%B at 26 weeks.|Mixed Models Analysis||||
1689665|NCT01126580|3107083|Superiority or Other||||||<|0.001||||||Treatment comparison of HOMA2-%B at 26 weeks.|Mixed Models Analysis||||
1689666|NCT01126580|3107084|Superiority or Other|||||||0.001||||||Treatment comparison at 52 weeks.|ANCOVA||||
1689667|NCT01126580|3107084|Superiority or Other|||||||0.412||||||Treatment comparison at 52 weeks.|ANCOVA||||
1689668|NCT01126580|3107084|Superiority or Other|||||||0.003||||||Treatment comparison at 26 weeks.|ANCOVA||||
1689669|NCT01126580|3107084|Superiority or Other|||||||0.75||||||Treatment comparison at 26 weeks.|ANCOVA||||
1689670|NCT01126580|3107085|Superiority or Other|||||||0.001||||||Treatment comparison at 52 weeks.|ANCOVA||||
1689671|NCT01126580|3107085|Superiority or Other|||||||0.44||||||Treatment comparison at 52 weeks.|ANCOVA||||
1689672|NCT01126580|3107085|Superiority or Other|||||||0.003||||||Treatment comparison at 26 weeks.|ANCOVA||||
1689673|NCT01126580|3107085|Superiority or Other|||||||0.811||||||Treatment comparison at 26 weeks.|ANCOVA||||
1689674|NCT01126580|3107086|Superiority or Other|||||||0.469||||||Treatment comparison at 52 weeks.|ANCOVA||||
1689675|NCT01126580|3107086|Superiority or Other|||||||0.022||||||Treatment comparison at 52 weeks.|ANCOVA||||
1689676|NCT01126580|3107086|Superiority or Other|||||||0.647||||||Treatment comparison at 26 weeks.|ANCOVA||||
1689677|NCT01126580|3107086|Superiority or Other|||||||0.061||||||Treatment comparison at 26 weeks.|ANCOVA||||
1689678|NCT01126580|3107087|Superiority or Other|||||||0.402||||||Treatment comparison at 52 weeks.|Mixed Models Analysis||||
1689679|NCT01126580|3107087|Superiority or Other|||||||0.025||||||Treatment comparison at 52 weeks.|Mixed Models Analysis||||
1689680|NCT01126580|3107087|Superiority or Other|||||||0.451||||||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1689681|NCT01126580|3107087|Superiority or Other|||||||0.079||||||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1689682|NCT01126580|3107088|Superiority or Other|||||||0.134||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic||||
1689683|NCT01126580|3107088|Superiority or Other||||||<|0.001||||||Treatment comparison for HbA1c less than or equal to 6.5% at 52 weeks.|Regression, Logistic||||
1689684|NCT01126580|3107088|Superiority or Other||||||<|0.269||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic||||
1689685|NCT01126580|3107088|Superiority or Other||||||<|0.001||||||Treatment comparison for HbA1c less than 7% at 52 weeks.|Regression, Logistic||||
1689686|NCT01126580|3107088|Superiority or Other||||||<|0.011||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic||||
1689687|NCT01126580|3107088|Superiority or Other||||||<|0.001||||||Treatment comparison for HbA1c less than or equal to 6.5% at 26 weeks.|Regression, Logistic||||
1689688|NCT01126580|3107088|Superiority or Other||||||<|0.021||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic||||
1689689|NCT01126580|3107088|Superiority or Other||||||<|0.023||||||Treatment comparison for HbA1c less than 7.0% at 26 weeks.|Regression, Logistic||||
1689690|NCT01126580|3107089|Superiority or Other||LS Mean Difference|-0.04||||0.299|2-Sided|95.0|-0.2|0.12||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.|
1689691|NCT01126580|3107089|Superiority or Other||LS Mean Difference|-0.19||||0.024|2-Sided|95.0|-0.35|-0.02||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.|
1689692|NCT01126580|3107089|Non-Inferiority or Equivalence|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.04|||<|0.001|2-Sided|95.0|-0.2|0.12||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA||||
1689693|NCT01126580|3107089|Non-Inferiority or Equivalence|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.19|||<|0.001|2-Sided|95.0|-0.35|-0.02||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA||||
1689694|NCT01126580|3107090|Superiority or Other||LS Mean Difference|-0.15||||0.02|2-Sided|95.0|-0.29|-0.01||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.|
1689695|NCT01126580|3107090|Superiority or Other||LS Mean Difference|-0.22||||0.002|2-Sided|95.0|-0.36|-0.08||Tree gatekeeping strategy to control the family-wise Type I error rate was applied.|ANCOVA|||Superiority analysis.|
1689696|NCT01126580|3107090|Non-Inferiority or Equivalence|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.15|||<|0.001|2-Sided|95.0|-0.29|-0.01||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA||||
1689697|NCT01126580|3107090|Non-Inferiority or Equivalence|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.22|||<|0.001|2-Sided|95.0|-0.36|-0.08||The p-value is adjusted for multiplicity using a tree-gatekeeping strategy. To determine significance, the p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||The study was designed with 90% power to detect non-inferiority of 1.5 mg LY2189265 vs Metformin on HbA1c change from baseline at the 26-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 2-sided alpha of 0.05 assuming no true difference between treatments. This corresponds to 223 participants per arm, with an assumed drop-out rate of 11%.|
1689698|NCT01126541|3107107|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||IV cortisone: Week 24 to Week 104|
1689699|NCT01126541|3107107|Superiority or Other||||||<|0.887|||||||Wilcoxon (Mann-Whitney)|||Oral cortisone: Week 24 to Week 104|
1689700|NCT01126541|3107107|Superiority or Other||||||<|0.278|||||||Wilcoxon (Mann-Whitney)|||Total cortisone: Week 24 to Week 104|
1689701|NCT01126541|3107108|Superiority or Other|||||||0.277|||||||Wilcoxon (Mann-Whitney)|||Weel 24 to Week 104|
1689702|NCT01126541|3107108|Superiority or Other|||||||0.374|||||||Wilcoxon (Mann-Whitney)|||1st retreatment to Week 104|
1689703|NCT01126541|3107108|Superiority or Other|||||||0.389|||||||Wilcoxon (Mann-Whitney)|||Day 1 to Week 104|
1689704|NCT01126541|3107128|Non-Inferiority or Equivalence|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean plus or minus (±)SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B – Arm A >20%. H1: Arm B – Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)|Adjusted difference|51.38|Standard Deviation|92.0|||2-Sided|95.0|-131.22|233.98|||||Covariate analysis with baseline DAS28-CRP value as covariate||
1689705|NCT01126541|3107129|Non-Inferiority or Equivalence|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B – Arm A >20%. H1: Arm B – Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)||||||0.524|||||||Student t-test|||Arm A vs. Arm B: Change from 2nd retreatment to 24 weeks after|
1689706|NCT01126541|3107129|Non-Inferiority or Equivalence|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B – Arm A >20%. H1: Arm B – Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided)||||||0.161|||||||Wilcoxon (Mann-Whitney)|||Arm A vs. Arm B: Change from 1st retreatment to 24 weeks after|
1689707|NCT01126541|3107129|Non-Inferiority or Equivalence|Primary objective to demonstrate noninferiority of retreatment with one 1000 mg rituximab infusion. Mean ±SD of the DAS28-CRP AUC at 24 months = 2218 ±967 (based on EDWARDS, REFLEX and DANCER study data). H0 (null hypothesis): Arm B – Arm A >20%. H1: Arm B – Arm A ≤ 20%. Power = 80%; Larger difference clinically acceptable = 20% = 444; Significance level of 2.5% (one-sided).||||||0.465|||||||Wilcoxon (Mann-Whitney)|||Change from Day 1 to Week 24 (initial treatment)|
1689708|NCT01126437|3107131|Superiority or Other||Hazard Ratio (HR)|1.054||||0.691|2-Sided|95.0|0.814|1.363|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.|
1689709|NCT01126437|3107131|Superiority or Other||Hazard Ratio (HR)|1.111||||0.4413|2-Sided|95.0|0.85|1.453|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.|
1689710|NCT01126437|3107131|Superiority or Other||Hazard Ratio (HR)|1.171||||0.2439|2-Sided|95.0|0.898|1.526|||Regression, Cox|||Time to death from MACE was analyzed using the full study duration including vital status follow-up.|
1689711|NCT01126437|3107132|Superiority or Other||Hazard Ratio (HR)|1.004||||0.9644|2-Sided|95.0|0.834|1.209|||Regression, Cox|||Causes of death from MACE were determined by adjudication.|
1689712|NCT01126437|3107132|Superiority or Other||Hazard Ratio (HR)|1.1||||0.3263|2-Sided|95.0|0.909|1.331|||Regression, Cox|||Causes of death from MACE were determined by adjudication.|
1689713|NCT01126437|3107132|Superiority or Other||Hazard Ratio (HR)|1.105||||0.3043|2-Sided|95.0|0.913|1.336|||Regression, Cox|||Causes of death from MACE were determined by adjudication.|
1689714|NCT01126437|3107133|Superiority or Other||Hazard Ratio (HR)|1.028||||0.3048|2-Sided|95.0|0.975|1.084|||Regression, Cox||||
1689715|NCT01126437|3107133|Superiority or Other||Hazard Ratio (HR)|0.983||||0.5377|2-Sided|95.0|0.932|1.037|||Regression, Cox||||
1689716|NCT01126437|3107133|Superiority or Other||Hazard Ratio (HR)|1.011||||0.6823|2-Sided|95.0|0.959|1.066|||Regression, Cox||||
1689717|NCT01126437|3107134|Superiority or Other||Rate ratio of events|1.03|Standard Error of the Mean|0.06||0.5573|2-Sided|95.0|0.92|1.16||p-value from negative binomial regression.|Negative binomial regression||||
1689718|NCT01126437|3107134|Superiority or Other||Rate ratio of events|1.06|Standard Error of the Mean|0.06||0.3441|2-Sided|95.0|0.94|1.18||p-value from negative binomial regression.|Negative binomial regression||||
1689719|NCT01126437|3107134|Superiority or Other||Rate ratio of events|1.09|Standard Error of the Mean|0.06||0.1255|2-Sided|95.0|0.98|1.22||p-value from negative binomial regression.|Negative binomial regression||||
1689720|NCT01126437|3107135|Superiority or Other||Hazard Ratio (HR)|1.044||||0.3784|2-Sided|95.0|0.949|1.148|||Regression, Cox||||
1689721|NCT01126437|3107135|Superiority or Other||Hazard Ratio (HR)|1.024||||0.6384|2-Sided|95.0|0.929|1.128|||Regression, Cox||||
1689722|NCT01126437|3107135|Superiority or Other||Hazard Ratio (HR)|1.068||||0.1762|2-Sided|95.0|0.971|1.176|||Regression, Cox||||
1689723|NCT01126437|3107136|Superiority or Other||Rate ratio of events|1.01|Standard Error of the Mean|0.03||0.6468|2-Sided|95.0|0.96|1.07|||Negative binomial regression||||
1689724|NCT01126437|3107136|Superiority or Other||Rate ratio of events|0.99|Standard Error of the Mean|0.03||0.8047|2-Sided|95.0|0.94|1.05|||Negative binomial regression||||
1689725|NCT01126437|3107136|Superiority or Other||Rate ratio of events|1.01|Standard Error of the Mean|0.03||0.833|2-Sided|95.0|0.95|1.06|||Negative binomial regression||||
1689726|NCT01126437|3107137|Non-Inferiority or Equivalence|The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL.|Adjusted mean difference|-0.037|Standard Error of the Mean|0.014|||2-Sided|95.0|-0.065|-0.009|||||Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient.|"FEV1 was analyzed through Week 120 using REML-based repeated measures.~H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler < 50 ml"|
1689727|NCT01126437|3107137|Non-Inferiority or Equivalence|The first test performed was to test the main effect for treatment in the mixed model repeated measures (MMRM) model, specifically the 95% CI for the contrast between Tio R 5ug and Tio HH 18ug was compared to the non-inferiority delta of 50 mL. If that test was successful, the second test in the hierarchy was to test the main effect for treatment in the MMRM model, specifically the 95% CI for the contrast between Tio R 2.5 ug and Tio HH 18 ug was compared to the non-inferiority delta of 50 mL.|Adjusted mean difference|-0.01|Standard Error of the Mean|0.014|||2-Sided|95.0|-0.038|0.018|||||Model included the fixed, categorical effects of treatment, investigative site, visit, and treatment-by-visit interaction, and continuous, fixed covariates of baseline and baseline-by-visit interaction, and a random term of patient.|"FEV1 was analyzed through Week 120 using REML-based repeated measures.~H0: Adjusted mean difference for Respimat/HandiHaler ≥ 50ml Ha: Adjusted mean difference for Respimat/HandiHaler < 50 ml"|
1689728|NCT01126437|3107138|Superiority or Other||Hazard Ratio (HR)|1.038||||0.1639|2-Sided|95.0|0.985|1.094|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"|
1689729|NCT01126437|3107138|Superiority or Other||Hazard Ratio (HR)|1.016||||0.5593|2-Sided|95.0|0.964|1.07|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"|
1689730|NCT01126437|3107138|Superiority or Other||Hazard Ratio (HR)|0.978||||0.4194|2-Sided|95.0|0.928|1.032|||Regression, Cox|||"H0: Hazard Ratio for Respimat/HandiHaler = 1 Ha: Hazard Ratio for Respimat/HandiHaler ≠ 1~at alpha = 0.05"|
1689731|NCT01126437|3107139|Non-Inferiority or Equivalence|Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05.|Hazard Ratio (HR)|0.996|||||2-Sided|95.0|0.872|1.136||||||H0: Hazard Ratio for Respimat/HandiHaler >= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler < 1.25|
1689732|NCT01126437|3107139|Non-Inferiority or Equivalence|Three tests were conducted in hierarchical order. Non-inferiority of time to death from any cause was tested on the two Respimat doses: Tio R 5 vs. Tio HH18, then if non-inferiority was achieved Tio R 2.5 vs Tio HH18. If successful, a test of superiority of Tio R5 over Tio HH18 for time to first COPD exacerbation was conducted. The non-inferiority delta for time to death was 1.25. Non-inferiority tests were performed at one-sided α=0.025 level. Superiority test was performed at two sided α=0.05.|Hazard Ratio (HR)|0.957|||||2-Sided|95.0|0.837|1.094||||||H0: Hazard Ratio for Respimat/HandiHaler >= 1.25 Ha: Hazard Ratio for Respimat/HandiHaler < 1.25|
1689733|NCT01126424|3107140|Superiority or Other||Least Square Mean Difference|157.783||||0.3526|2-Sided|95.0|-182.015|497.581|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."|
1689956|NCT01122849|3107606|Superiority or Other||LS mean difference|1.35||||0.0381|2-Sided|95.0|0.08|2.62||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7|
1689734|NCT01126424|3107140|Superiority or Other||Least Square Mean Difference|-77.919||||0.5953|2-Sided|95.0|-372.814|216.976|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."|
1689735|NCT01126424|3107141|Superiority or Other||Least Square Mean Difference|-1.457||||0.867|2-Sided|95.0|-18.976|16.062|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."|
1689736|NCT01126424|3107141|Superiority or Other||Least Square Mean Difference|4.655||||0.6315|2-Sided|95.0|-14.858|24.167|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."|
1689737|NCT01126424|3107142|Superiority or Other||Least Square Mean Difference|-0.046||||0.5361|2-Sided|95.0|-0.194|0.103|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."|
1689738|NCT01126424|3107142|Superiority or Other||Least Square Mean Difference|-0.04||||0.6275|2-Sided|95.0|-0.208|0.127|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."|
1689739|NCT01126424|3107143|Superiority or Other||Least Square Mean Difference|-0.792||||0.2348|2-Sided|95.0|-2.122|0.538|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."|
1689740|NCT01126424|3107143|Superiority or Other||Least Square Mean Difference|-0.507||||0.5684|2-Sided|95.0|-2.293|1.279|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."|
1689741|NCT01126424|3107144|Superiority or Other||Least Square Mean Difference|1.846||||0.6753|2-Sided|95.0|-7.02|10.713|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."|
1689742|NCT01126424|3107144|Superiority or Other||Least Square Mean Difference|9.152||||0.0505|2-Sided|95.0|-0.023|18.326|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."|
1689743|NCT01126424|3107145|Superiority or Other||Least Square Mean Difference|17.508||||0.4487|2-Sided|95.0|-28.854|63.87|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of oxybutynin versus placebo change from Baseline at 2 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."|
1689744|NCT01126424|3107145|Superiority or Other||Least Square Mean Difference|-20.986||||0.3771|2-Sided|95.0|-68.58|26.607|||ANCOVA|The analysis was performed using an ANCOVA model with fixed effect for treatment, period, subjects as a random effect and baseline as a covariate.||"Comparison of solifenacin versus placebo change from Baseline at 6 hours~The null hypothesis was that the mean change from baseline was the same in both treatments."|
1689745|NCT01125930|3107172|Superiority or Other|||||||0.42|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.|
1689746|NCT01125930|3107172|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 21 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.|
1689747|NCT01125930|3107172|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.|
1689748|NCT01125930|3107172|Superiority or Other|||||||0.67|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial burning upon product application.|
1689749|NCT01125930|3107173|Superiority or Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.|
1689957|NCT01122849|3107606|Superiority or Other||LS mean difference|-0.04||||0.8495|2-Sided|95.0|-0.42|0.35||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q2 at Day 7|
1689750|NCT01125930|3107173|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.|
1689751|NCT01125930|3107173|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.|
1689752|NCT01125930|3107173|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial itching upon product application.|
1689753|NCT01125930|3107174|Superiority or Other|||||||0.1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.|
1689754|NCT01125930|3107174|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.|
1689755|NCT01125930|3107174|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.|
1689756|NCT01125930|3107174|Superiority or Other||||||<|0.21|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an assessment of skin irritation by facial stinging upon product application.|
1689757|NCT01125930|3107175|Superiority or Other|||||||0.17|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.|
1689758|NCT01125930|3107175|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.|
1689759|NCT01125930|3107175|Superiority or Other|||||||0.88|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.|
1689760|NCT01125930|3107175|Superiority or Other|||||||0.36|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.|
1689761|NCT01125930|3107176|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.|
1689762|NCT01125930|3107176|Superiority or Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.|
1689763|NCT01125930|3107176|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.|
1689764|NCT01125930|3107176|Superiority or Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.|
1689765|NCT01125930|3107177|Superiority or Other|||||||0.46|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.|
1689931|NCT01123083|3107552|Superiority or Other||Mean Difference (Net)|0.04||||0.402|2-Sided|95.0|-0.05|0.13|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Month 12|
1689766|NCT01125930|3107177|Superiority or Other|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.|
1689767|NCT01125930|3107177|Superiority or Other|||||||0.31|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.|
1689768|NCT01125930|3107177|Superiority or Other|||||||0.8|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.|
1689769|NCT01125930|3107178|Superiority or Other|||||||0.35|||||||Fisher Exact|||Group comparison at Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.|
1689770|NCT01125930|3107178|Superiority or Other|||||||0.7|||||||Fisher Exact|||Group comparison at Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.|
1689771|NCT01125930|3107178|Superiority or Other|||||||0.7|||||||Fisher Exact|||Group comparison at Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.|
1689772|NCT01125930|3107178|Superiority or Other|||||||0.18|||||||Fisher Exact|||Group comparison at Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have different values than the other.|
1689773|NCT01125930|3107179|Superiority or Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.|
1689774|NCT01125930|3107179|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.|
1689775|NCT01125930|3107179|Superiority or Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.|
1689776|NCT01125930|3107179|Superiority or Other|||||||0.54|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.|
1689777|NCT01125930|3107180|Superiority or Other|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.|
1689778|NCT01125930|3107180|Superiority or Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.|
1689779|NCT01125930|3107180|Superiority or Other|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.|
1689780|NCT01125930|3107180|Superiority or Other|||||||0.29|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.|
1689781|NCT01125930|3107181|Superiority or Other|||||||0.91|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.|
1689782|NCT01125930|3107181|Superiority or Other|||||||0.96|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.|
1689783|NCT01125930|3107181|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.|
1689784|NCT01125930|3107181|Superiority or Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.|
1690284|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-0.622|||||2-Sided|95.0|-15.63|14.38|||||Day 14, 24 Hours||
1689785|NCT01125930|3107182|Superiority or Other|||||||0.77|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to provide an overall self-assessment of product tolerance.|
1689786|NCT01125930|3107183|Superiority or Other|||||||0.68|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial stinging.|
1689787|NCT01125930|3107184|Superiority or Other|||||||0.75|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess self-reported facial burning.|
1689788|NCT01125930|3107185|Superiority or Other|||||||1|||||||Fisher Exact|||Group comparison at Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.|
1689789|NCT01125930|3107186|Superiority or Other|||||||0.13|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess dry skin.|
1689790|NCT01125930|3107187|Superiority or Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess facial edema.|
1689791|NCT01125930|3107188|Superiority or Other|||||||0.94|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.|
1689792|NCT01125930|3107188|Superiority or Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.|
1689793|NCT01125930|3107188|Superiority or Other|||||||0.44|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.|
1689794|NCT01125930|3107188|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.|
1689795|NCT01125930|3107189|Superiority or Other|||||||0.61|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-9 at Week 24 visit were made using fold change data.|
1689796|NCT01125930|3107189|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-3 at Week 24 visit were made using fold change data.|
1689797|NCT01125930|3107189|Superiority or Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of MMP-1 at Week 24 visit were made using fold change data.|
1689798|NCT01125930|3107189|Superiority or Other|||||||0.25|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of COL-3 at Week 24 visit were made using fold change data.|
1689799|NCT01125930|3107189|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of COL-1 at Week 24 visit were made using fold change data.|
1689800|NCT01125930|3107190|Superiority or Other|||||||0.76|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of TNFa at Week 24 visit were made using fold change data.|
1689801|NCT01125930|3107190|Superiority or Other|||||||0.68|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of CXCL12 at Week 24 visit were made using fold change data.|
1689802|NCT01125930|3107190|Superiority or Other|||||||0.35|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of CXCR4 at Week 24 visit were made using fold change data.|
1689803|NCT01125930|3107190|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons of TAC1 at Week 24 visit were made using fold change data.|
1689804|NCT01125930|3107191|Superiority or Other|||||||0.8|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.|
1689805|NCT01125930|3107191|Superiority or Other|||||||0.92|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.|
1689806|NCT01125930|3107191|Superiority or Other|||||||0.66|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.|
1689952|NCT01122849|3107605|Superiority or Other||LS Mean Difference|0.06||||0.6935|2-Sided|95.0|-0.26|0.39||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14|
1689807|NCT01125930|3107191|Superiority or Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.|
1689808|NCT01125930|3107191|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.|
1689809|NCT01125930|3107192|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.|
1689810|NCT01125930|3107192|Superiority or Other|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.|
1689811|NCT01125930|3107192|Superiority or Other|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.|
1689812|NCT01125930|3107192|Superiority or Other|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.|
1689813|NCT01125930|3107192|Superiority or Other|||||||0.53|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess phymatous changes of rosacea.|
1689814|NCT01125930|3107193|Superiority or Other|||||||0.45|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea|
1689815|NCT01125930|3107193|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea|
1689816|NCT01125930|3107193|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum test with exact p-values||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea|
1689817|NCT01125930|3107193|Superiority or Other|||||||0.62|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea|
1689818|NCT01125930|3107193|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess ocular manifestations of rosacea.|
1689819|NCT01125930|3107194|Superiority or Other|||||||0.87|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess photodamage.|
1689820|NCT01125930|3107195|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.|
1689821|NCT01125930|3107195|Superiority or Other|||||||0.38|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 18 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.|
1689822|NCT01125930|3107195|Superiority or Other|||||||0.66|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 12 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.|
1689823|NCT01125930|3107195|Superiority or Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 6 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.|
1689824|NCT01125930|3107195|Superiority or Other|||||||0.94|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values to address non-normality of data.||Group comparisons were done at the Week 2 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other.|
1690634|NCT01118273|3108529|Superiority or Other|||||||0.55|||||||ANCOVA||||
1689825|NCT01125930|3107196|Superiority or Other|||||||0.79|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess telangiectasia.|
1689826|NCT01125930|3107197|Superiority or Other|||||||0.93|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test with exact p-values.||Group comparisons were done at the Week 24 visit. The null hypothesis that the two groups are the same, was tested against the alternative hypothesis that one group tended to have larger values than the other over the ordinally scaled categories used to assess redness.|
1689827|NCT01125774|3107210|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.393|2-Sided|95.0|-0.4|0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo||
1689828|NCT01125774|3107211|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.001|2-Sided|95.0|-0.5|-0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo||
1689829|NCT01125774|3107212|Superiority or Other||Mean Difference (Final Values)|-0.4|||<|0.001|2-Sided|95.0|-0.5|-0.2||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo||
1689830|NCT01125774|3107213|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.369|2-Sided|95.0|-1.0|0.4||To control Type I error, formal significance of the test for treatment difference for this measure could only be achieved if the comparison corresponding to the primary hypothesis was significant at α=0.0499|LDA||Difference is Telcagepant 140 mg versus Placebo||
1689831|NCT01125774|3107214|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.13|2-Sided|95.0|-1.1|0.1||α=0.0499|Longitudinal data analysis (LDA)||Difference is Telcagepant 140 mg versus Placebo|This measure tests the primary hypothesis, that telcagepant 140 mg is superior to placebo as measured by mean monthly headache days in participants with MRM or PMM|
1689832|NCT01125774|3107216|Superiority or Other||Difference in percent incidence|0.6|||||2-Sided|95.0|-0.5|1.6|||||Telcagepant percent incidence versus Placebo percent incidence||
1689833|NCT01125774|3107217|Superiority or Other||Difference in percent incidence|-0.2|||||2-Sided|95.0|-1.4|0.8|||||Telcagepant percent incidence versus Placebo percent incidence||
1689834|NCT01125774|3107218|Superiority or Other||Difference in percent incidence|-1.2|||||2-Sided|95.0|-4.4|2.1|||||Telcagepant percent incidence versus Placebo percent incidence||
1689835|NCT01125748|3107220|Superiority or Other||Mean Difference (Final Values)|19.3|||||2-Sided|95.0|5.0|33.6|||||||
1689836|NCT01125605|3107228|Superiority or Other|||||||0.0002|||||||Fisher Exact||||
1689837|NCT01125605|3107230|Superiority or Other|||||||0.0504|||||||Fisher Exact||||
1689838|NCT01125605|3107231|Superiority or Other|||||||0.0016|||||||Fisher Exact||||
1689839|NCT01125605|3107232|Superiority or Other|||||||0.0006|||||||Fisher Exact||||
1689840|NCT01125605|3107233|Superiority or Other|||||||0.0125|||||||Fisher Exact||||
1689841|NCT01125605|3107234|Superiority or Other|||||||0.0014|||||||Fisher Exact||||
1689842|NCT01125605|3107235|Superiority or Other|||||||0.0002|||||||ANCOVA|ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate||decrease of the sum score between baseline (visit1) and last observation by duration of treatment|
1689843|NCT01125605|3107235|Superiority or Other|||||||0.0033|||||||ANCOVA|ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate||decrease of the sum score between baseline (visit 1) and last observation was exploratively analysed|
1689844|NCT01125566|3107237|Superiority or Other||Odds Ratio (OR)|1.029||||0.8829||95.0|0.707|1.496|||Regression, Logistic|Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours AV.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)|
1689845|NCT01125566|3107238|Superiority or Other||Odds Ratio (OR)|1.09||||0.6431||95.0|0.756|1.572|||Regression, Logistic|Logistic regression stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|The odds ratio for the comparison afatinib + vinorelbine vs. trastuzumab + vinorelbine below 1 favours Afatinib.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)|
1689846|NCT01125566|3107239|Superiority or Other||Hazard Ratio (HR)|1.3||||0.024|2-Sided|95.0|1.03|1.63||Two sided p-value from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Regression, Cox||Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Results of presented analyses are to be seen as exploratory (no confirmatory testing was performed)|
1689847|NCT01125566|3107240|Superiority or Other||Hazard Ratio (HR)|1.1||||0.4224||95.0|0.87|1.41||Two sided p-value was derived from a log rank test stratified by the setting of prior Trastuzumab failure, hormone receptors status and region of the investigational site.|Regression, Cox||Hazard ratio is derived from Cox proportional hazard model stratified by prior Trastuzumab failure, hormone receptors status and region of the investigational site.||
1689848|NCT01125163|3107279|Superiority or Other|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were transfused could be included in an intention-to-treat analysis. Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wks PMA Hct was used as the primary outcome.|
1689953|NCT01122849|3107605|Superiority or Other||LS Mean difference|-0.09||||0.5741|2-Sided|95.0|-0.41|0.23||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14|
1689849|NCT01125163|3107280|Superiority or Other|||||||0.59||||||All infants were analyzed according to their assigned groups.|Wilcoxon (Mann-Whitney)|||A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and infants who were transfused could be included in an intention-to-treat analysis. Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wks PMA Hct was used as the primary outcome.|
1689850|NCT01124955|3107290|Superiority or Other||||||,|0|||||||ANOVA||||
1689851|NCT01124916|3107292|Superiority or Other||Mean Difference (Net)|6.2|Standard Error of the Mean|7.846||0.43|2-Sided|95.0|-21.769|9.369|||t-test, 2 sided|||The null hypothesis is that there is no difference in urinary distress between women assigned to LASC and those assigned to RASC six months after intervention as measured by the UDI.|
1689852|NCT01124916|3107293|Superiority or Other||Mean Difference (Net)|8728.0|Standard Error of the Mean|853.129|<|0.001|2-Sided|95.0|7028.846|10427.154|||t-test, 2 sided|||The null hypothesis is that there is no difference in the total cost of care between standard and robotic-assisted laparoscopic abdominal sacrocolpopexy six weeks after surgery.|
1689853|NCT01124838|3107300|Superiority or Other||Mean Difference|-0.49||||0.842|2-Sided|95.0|-5.32|4.34|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese vs. non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689854|NCT01124838|3107300|Superiority or Other||Mean Difference|0.56||||0.83|2-Sided|95.0|-4.56|5.68|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689855|NCT01124838|3107301|Superiority or Other||Mean Difference|-0.87||||0.714|2-Sided|95.0|-5.53|3.79|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689856|NCT01124838|3107301|Superiority or Other||Mena Difference|-0.1||||0.967|2-Sided|95.0|-4.81|4.61|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689857|NCT01124838|3107302|Superiority or Other||Mean Difference|2.36||||0.256|2-Sided|95.0|-1.73|6.45|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689858|NCT01124838|3107302|Superiority or Other||Mean Difference|1.88||||0.401|2-Sided|95.0|-2.53|6.29|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689859|NCT01124838|3107303|Superiority or Other||Mean Difference|1.77||||0.205|2-Sided|95.0|-0.97|4.52|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and race (Japanese versus non-Japanese) as factors.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689860|NCT01124838|3107303|Superiority or Other||Mean Difference|2.12||||0.16|2-Sided|95.0|-0.84|5.08|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as a factor.||The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689861|NCT01124838|3107304|Superiority or Other||Mean Difference|-3.9||||0.174|2-Sided|95.0|-9.7|1.8|||ANOVA|From ANOVA with treatment, race (Japanese versus non-Japanese) and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689862|NCT01124838|3107304|Superiority or Other||Mean Difference|-2.3||||0.451|2-Sided|95.0|-8.5|3.8|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment and OCT machine as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689863|NCT01124838|3107305|Superiority or Other||Hazard Ratio (HR)|0.6||||0.185|2-Sided|95.0|0.28|1.28|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689864|NCT01124838|3107305|Superiority or Other||Hazard Ratio (HR)|0.75||||0.491|2-Sided|95.0|0.34|1.69|||Log Rank||The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689865|NCT01124838|3107306|Superiority or Other||Mean Difference|-0.04||||0.044|2-Sided|95.0|-0.09|0.0|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689866|NCT01124838|3107306|Superiority or Other||Mean Difference|-0.04||||0.096|2-Sided|95.0|-0.08|0.01|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as factor adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1690635|NCT01118273|3108530|Superiority or Other|||||||0.53|||||||ANCOVA||||
1689867|NCT01124838|3107307|Superiority or Other||Mean Difference|-0.17||||0.016|2-Sided|95.0|-0.31|-0.03|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689868|NCT01124838|3107307|Superiority or Other||Mean Difference|-0.13||||0.07|2-Sided|95.0|-0.28|0.01|||ANOVA|From ANOVA of change from baseline to final/early termination visit with treatment as factor|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689869|NCT01124838|3107308|Superiority or Other||Mean Difference|-0.15||||0.164|2-Sided|95.0|-0.36|0.06|||ANOVA|From ANOVA with treatment and race (Japanese versus non-Japanese) as factors adjusted for clustered observations.|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689870|NCT01124838|3107308|Superiority or Other||Mean Difference|-0.14||||0.218|2-Sided|95.0|-0.37|0.08|||ANOVA|From ANOVA with treatment as factor adjusted for clustered observations (i.e., observations from each of the participant's eyes).|The mean difference between treatment groups with its 95% confidence interval is based on individual data from all eyes adjusted for correlated measurements within a subject in an analysis of variance (ANOVA) model.|The statistical test for the ranked secondary variables was carried out in hierarchical order at the significance level of 5%.|
1689871|NCT01124838|3107309|Superiority or Other||Hazard Ratio (HR)|0.52|||<|0.001|2-Sided|95.0|0.37|0.74|||Log Rank|||An additional analysis of the primary endpoint was performed using the Integrated Study data (Main Study + Japan sub-study). The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment and race (Japanese versus non-Japanese) as factors.|
1689872|NCT01124838|3107309|Superiority or Other||Hazard Ratio (HR)|0.57|||<|0.004|2-Sided|95.0|0.39|0.84|||Log Rank|||The primary analysis of the primary endpoint was performed on Main Study data, excluding the Japanese sub-study. The statistical test was performed at a 2-sided significance level of 0.05. The hazard ratio of adalimumab versus placebo was calculated using proportional hazards regression with treatment as factor.|
1689873|NCT01124786|3107317|Superiority or Other||Hazard Ratio (HR)|0.994|||<|0.973|2-Sided|95.0|0.746|1.326|||Log Rank||Hazard ratio and confidence interval presented above, so parameter dispersion not indicated in standard deviation field directly above.|If the median Overall Survival (OS) for the CO-1.01-treated patients is 7.7 months and the median OS for gemcitabine-treated patients with hENT1-low status is 4 months (hazard ratio of 0.53), then a total of 144 events of death in the hENT1-low subgroup will provide over 90% power at a 0.05 (2 sided) significance level for the comparison of CO-1.01 to gemcitabine in the hENT1-low patients.|
1689874|NCT01124604|3107360|Superiority or Other||Least Square (LS) Mean Difference|-0.1|Standard Error of the Mean|0.46||||95.0|-1.04|0.8|||||Test for no difference between treatments was derived from Analysis of covariance (ANCOVA) model with factors treatment, disease and Baseline pain intensity as covariate.||
1689875|NCT01124422|3107384|Superiority or Other||Mean Difference (Final Values)|-27.6|Standard Error of the Mean|20.58||0.181|2-Sided|95.0|-68.2|13.0||ANCOVA model with terms for treatment, investigator, Oxycon stratum, and baseline value|ANCOVA||||
1689876|NCT01124370|3107391|Superiority or Other||||||<|0.001||||||The test was conducted using a 0.05 level of significance.|t-test, 2 sided|||The null hypothesis was that there would be no change in AHI from baseline.|
1689877|NCT01124188|3107414|Superiority or Other|||||||0.88|||||||Mixed Models Analysis||||
1689878|NCT01124188|3107415|Superiority or Other|||||||0.49|||||||Mixed Models Analysis||||
1689879|NCT01124188|3107416|Superiority or Other||Hazard Ratio (HR)|1.07|||||2-Sided|95.0|0.63|1.8|||||||
1689880|NCT01124175|3107417|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|102.36|||||2-Sided|90.0|100.41|104.34|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1689881|NCT01124175|3107418|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|103.07|||||2-Sided|90.0|100.9|105.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1689882|NCT01124175|3107419|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.97|||||2-Sided|90.0|101.22|110.93|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1689883|NCT01124175|3107420|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.67|||||2-Sided|90.0|103.32|108.07|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1689884|NCT01124175|3107421|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|105.97|||||2-Sided|90.0|103.61|108.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1690636|NCT01118273|3108532|Superiority or Other|||||||0.35|||||||Cochran-Mantel-Haenszel||||
1689885|NCT01124175|3107422|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|111.95|||||2-Sided|90.0|101.84|123.06|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1689886|NCT01124162|3107423|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|100.25|||||2-Sided|90.0|97.87|102.69|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1689887|NCT01124162|3107424|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|100.31|||||2-Sided|90.0|97.84|102.84|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1689888|NCT01124162|3107425|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|102.08|||||2-Sided|90.0|98.24|106.06|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1689889|NCT01124162|3107426|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|101.5|||||2-Sided|90.0|98.41|104.68|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1689890|NCT01124162|3107427|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|101.7|||||2-Sided|90.0|98.57|104.93|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1689891|NCT01124162|3107428|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level.|Ratio of the T/R geometric mean x 100|108.14|||||2-Sided|90.0|97.43|120.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.||
1689892|NCT01124149|3107435|Superiority or Other||Odds Ratio (OR)|2.1|||<|0.001|2-Sided|95.0|1.44|3.07|||Regression, Logistic||||
1689893|NCT01124149|3107436|Superiority or Other||Odds Ratio (OR)|2.61|||<|0.001|2-Sided|95.0|1.76|3.87|||Regression, Logistic||||
1689894|NCT01124097|3107437|Superiority or Other|||||||0.4764|||||||Dunnett's test||||
1689895|NCT01124097|3107437|Superiority or Other|||||||0.261|||||||Dunnett's test||||
1689896|NCT01124097|3107437|Superiority or Other|||||||0.9321|||||||Dunnett's test||||
1689897|NCT01123980|3107461|Superiority or Other||Odds Ratio (OR)|1.07||||0.8013||95.0|0.64|1.79|||Regression, Logistic||The odds ratio and 95% confidence interval is for the HbA1c below or equal to 6.5% treatment target were included.|The responder analysis was based on logistic regression model using treatment, country and previous OAD therapy (with or without a third OAD) as factors and baseline HbA1c as covariate.|
1689898|NCT01123980|3107462|Superiority or Other||Odds Ratio (OR)|0.96||||0.8583||95.0|0.64|1.46|||Regression, Logistic||The odds ratio and 95% confidence interval is for the HbA1c less than 7% treatment target were included.|The responder analysis was based on logistic regression model using treatment, country and previous OAD therapy (with or without a third OAD) as factors and baseline HbA1c as covariate.|
1689899|NCT01123980|3107463|Superiority or Other||Mean Difference (Final Values)|0.17|||<|0.001||95.0|-0.06|0.4||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before breakfast the following day|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.|
1689900|NCT01123980|3107463|Superiority or Other||Mean Difference (Final Values)|-0.47|||<|0.001||95.0|-0.81|-0.13||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||02 - 04 a.m.|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.|
1689901|NCT01123980|3107463|Superiority or Other||Mean Difference (Final Values)|-1.25|||<|0.001||95.0|-1.73|-0.78||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Bedtime|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.|
1689902|NCT01123980|3107463|Superiority or Other||Mean Difference (Final Values)|-1.51|||<|0.001||95.0|-2.03|-1.0||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after dinner|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.|
1689903|NCT01123980|3107463|Superiority or Other||Mean Difference (Final Values)|0.64|||<|0.001||95.0|0.22|1.06||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before dinner|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.|
1689904|NCT01123980|3107463|Superiority or Other||Mean Difference (Final Values)|0.28|||<|0.001||95.0|-0.26|0.82||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after lunch|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.|
1689954|NCT01122849|3107606|Superiority or Other||LS mean difference|0.81||||0.202|2-Sided|95.0|-0.45|2.07||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7|
1689905|NCT01123980|3107463|Superiority or Other||Mean Difference (Final Values)|0.14|||<|0.001||95.0|-0.31|0.58||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before lunch|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.|
1689906|NCT01123980|3107463|Superiority or Other||Mean Difference (Final Values)|0.07|||<|0.001||95.0|-0.45|0.58||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Two hours after breakfast|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.|
1689907|NCT01123980|3107463|Superiority or Other||Mean Difference (Final Values)|-0.03|||<|0.001||95.0|-0.24|0.19||P-value for parallelism is overall test for parallel time profiles between treatment groups.|Mixed Models Analysis||Before breakfast|Repeated measures mixed model with an unstructured residual covarience matrix, including treatment, time, the treatment-by-time interaction, country and previous OADs as factors.|
1689908|NCT01123980|3107464|Non-Inferiority or Equivalence|Non-inferiority was considered to be confirmed if the upper bound of the two-sided 95% confidence interval (CI) was below or equal to 0.4% or equivalent if the p-value for the one-sided test of H0: D > 0.4% against HA: D =< 0.4%, was less than or equal to 2.5%, where D is the mean treatment difference (investigational product minus comparator). Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0%|Mean Difference (Net)|-0.12|Standard Error of the Mean|0.07|<|0.001||95.0|-0.25|0.02||The p-values correspond to one-sided hypotheses of either non-inferiority or superiority, statistical significance level is 2.5%.|ANCOVA|The estimates are from a normal linear regression model with treatment, country and previous OADs as factors and baseline HbA1c as a covariate||H0: The mean treatment difference (BIAsp 30 minus insulin glargine) > 0.4%. HA: The mean treatment difference (BIAsp 30 minus insulin glargine) =< 0.4%. Sample size was calculated to achieve a power of at least 90%, assuming an equal change in HbA1c and a common standard deviation of 1.25%|
1689909|NCT01123655|3107511|Equivalence|p value greater than 0.05 was the criteria for equivalence.|||||>|0.05||||||P value is applicable to IL-17a, IL-10, IL-1b, IL-9, IL-13, IL-5, IL-21, IL-6, TNFa, TGFb, MIP3a.|t-test, 2 sided||||
1689910|NCT01123655|3107512|Equivalence|P greater than 0.05 was the criteria for equivalence.|||||>|0.05||||||P value is applicable for baseline and follow-up data.|Mixed Models Analysis||||
1689911|NCT01123655|3107514|Equivalence|Null hypothesis was that the response rate in the placebo group is not significantly difference from the 50% spontaneous response rate.||||||0.4142|||||||Exact Test||||
1689912|NCT01123655|3107514|Equivalence|Null hypothesis was that the response rate in the APL treated groups is not significantly difference from the 50% spontaneous response rate.||||||0.0114|||||||Exact Test||||
1689913|NCT01123655|3107514|Equivalence|P less than 0.05 was the criteria for equivalence.||||||0.5179|||||||Fisher Exact|||Specified to be a reduction from baseline values of net IFNƔ concentration of ≥ 25% in αl(ll)-stimulated PBMC culture supernatants (calculated as αI(II)-IFNƔ-PBS IFNƔ in patients receiving APL A12 compared to placebo.|
1689914|NCT01123512|3107519|Non-Inferiority or Equivalence|"Pr( Pt – Pc > –12.5% | data), calculated using Bayesian multiple imputation for missing 12-month values, as specified in the protocol. The Kiva System is declared non-inferior to control if Pr( Pt – Pc > –12.5% | data)> 96.6%."|% Probability of Equivalence = 99.92|99.92|||||2-Sided||||||||||
1689915|NCT01123382|3107523|Superiority or Other|||||||0.69||||||group x time interaction 0.69|Mixed Models Analysis||||
1689916|NCT01123382|3107524|Superiority or Other|||||||0.59||||||group x time interaction 0.59|Mixed Models Analysis||||
1689917|NCT01123382|3107525|Superiority or Other|||||||0.46||||||group x time interaction 0.46|Mixed Models Analysis||||
1689918|NCT01123382|3107526|Superiority or Other|||||||0.398||||||group x time interaction 0.398|Mixed Models Analysis||||
1689919|NCT01123382|3107527|Superiority or Other|||||||0.61||||||group x time 0.61|Mixed Models Analysis||||
1689920|NCT01123382|3107528|Superiority or Other|||||||0.33||||||group x time interaction 0.33|Mixed Models Analysis||||
1689921|NCT01123382|3107529|Superiority or Other|||||||0.543||||||group x time interaction 0.543|Mixed Models Analysis||||
1689922|NCT01123382|3107530|Superiority or Other|||||||0.059||||||group x time interaction 0.059|Mixed Models Analysis||||
1689923|NCT01123382|3107531|Superiority or Other|||||||0.04||||||Group X time interaction|Mixed Models Analysis|we included a random intercept for each individual participant. We used a first-order antedependent covariance structure.||To detect a minimum clinically important difference of 2 points2 on the BPI-SF3 with an anticipated standard deviation for each mean of 2.5, estimated from a prior study, with an alpha level of 0.05 and a power of 80%, for five waves of data, a sample size of 10 participants per group was necessary. With anticipated dropouts, a sample size of at least 12 participants per group was required.|
1689924|NCT01123083|3107547|Superiority or Other|||||||0.373|||||||Hochberg-adjusted p-value|||Month 12|
1689925|NCT01123083|3107547|Superiority or Other|||||||0.123|||||||Hochberg-adjusted p-value|||Month 6|
1689926|NCT01123083|3107548|Superiority or Other|||||||0.452|||||||Hochberg-adjusted p-value|||Month 12|
1689927|NCT01123083|3107548|Superiority or Other|||||||0.452|||||||Hochberg-adjusted p-value|||Month 6|
1689928|NCT01123083|3107551|Superiority or Other||Mean Difference (Net)|0.13||||0.572|2-Sided|95.0|-0.33|0.59|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Month 12|
1689929|NCT01123083|3107551|Superiority or Other||Mean Difference (Net)|0.0||||0.987|2-Sided|95.0|-0.46|0.45|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Month 6|
1689930|NCT01123083|3107551|Superiority or Other||Mean Difference (Net)|-0.18||||0.582|2-Sided|95.0|-0.52|0.16|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and baseline HbA1c. Confidence Interval, not adjusted for multiple comparisons.|Week 12|
1689955|NCT01122849|3107606|Superiority or Other||LS mean difference|0.54||||0.4005|2-Sided|95.0|-0.74|1.82||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7|
1689932|NCT01123083|3107552|Superiority or Other||Mean Difference (Net)|-0.04||||0.21|2-Sided|95.0|-0.11|0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Month 6|
1689933|NCT01123083|3107552|Superiority or Other||Mean Difference (Net)|-0.03||||0.21|2-Sided|95.0|-0.08|0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline Mean Daily Insulin Use. Confidence Interval, not adjusted for multiple comparisons.|Week 12|
1689934|NCT01123083|3107553|Superiority or Other||Odds Ratio (OR)|1.56||||0.412|2-Sided|95.0|0.54|4.52|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Month 12|
1689935|NCT01123083|3107553|Superiority or Other||Odds Ratio (OR)|0.95||||0.912|2-Sided|95.0|0.37|2.42|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Month 6|
1689936|NCT01123083|3107553|Superiority or Other||Odds Ratio (OR)|1.29||||0.912|2-Sided|95.0|0.5|3.37|||GEE Model||Estimated treatment group difference, adjusted for age, region and Baseline HbA1c/Insulin Use Response. Confidence Interval, not adjusted for multiple comparisons.|Week 12|
1689937|NCT01123083|3107555|Superiority or Other||Mean Difference (Net)|-0.06||||0.191|2-Sided|95.0|-0.15|0.03|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|Month 6|
1689938|NCT01123083|3107555|Superiority or Other||Mean Difference (Net)|-0.1||||0.022|2-Sided|95.0|-0.18|-0.02|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.|Week 12|
1689939|NCT01123083|3107556|Superiority or Other||Mean Difference (Net)|-0.09||||0.051|2-Sided|95.0|-0.17|0.0|||Repeated Measures Mixed Effects Model||Estimated treatment group difference, adjusted for age, region and Baseline C-peptide AUC. Confidence Interval, not adjusted for multiple comparisons.||
1689940|NCT01122862|3107588|Superiority or Other||Adjusted Mean Difference|0.88|||<|0.0001|2-Sided|95.0|0.68|1.08||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.|
1689941|NCT01122862|3107588|Superiority or Other||Adjusted Mean Difference|0.03|||<|0.728||95.0|-0.16|0.23||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.|
1689942|NCT01122862|3107589|Superiority or Other||Adjusted Mean Difference|1.68|||<|0.0001|2-Sided|95.0|1.44|1.93||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.|
1689943|NCT01122862|3107589|Superiority or Other||Adjusted Mean Difference|-0.2|||<|0.11|2-Sided|95.0|-0.44|0.05||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.|
1689944|NCT01122862|3107590|Superiority or Other||Adjusted Mean DIfference|0.74|||<|0.0001|2-Sided|95.0|0.57|0.92||No adjustment for multiple comparisons was made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.|
1689945|NCT01122862|3107590|Superiority or Other||Adjusted Mean Difference|0.04|||<|0.6682|2-Sided|95.0|-0.14|0.21|||ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.|
1689946|NCT01122862|3107591|Superiority or Other||Adjusted Mean Difference|1.66|||<|0.0001|2-Sided|95.0|1.42|1.9||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference in treatments being compared.|
1689947|NCT01122862|3107592|Superiority or Other||Adjusted Mean Difference|-0.21||||0.0915|2-Sided|95.0|-0.45|0.03||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate.|Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment.|Null hypothesis was no difference between treatments being compared.|
1689948|NCT01122849|3107605|Superiority or Other||LS mean difference|1.06||||0.1091|2-Sided|95.0|-0.25|2.37||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for Q4 at Day 14|
1689949|NCT01122849|3107605|Superiority or Other||LS Mean difference|0.32||||0.6333|2-Sided|95.0|-1.02|1.67||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14|
1689950|NCT01122849|3107605|Superiority or Other||LS Mean difference|1.39||||0.0434|2-Sided|95.0|0.04|2.73||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14|
1689951|NCT01122849|3107605|Superiority or Other||LS mean difference|-0.15||||0.333|2-Sided|95.0|-0.47|0.16||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison of Q2 at Day 14|
1690285|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-8.718|||||2-Sided|95.0|-23.71|6.28|||||Day 14, 24 Hours||
1689958|NCT01122849|3107606|Superiority or Other||LS Mean difference|-0.21||||0.2964|2-Sided|95.0|-0.6|0.19||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q2 at Day 7|
1689959|NCT01122849|3107606|Superiority or Other||LS Mean Difference|-0.24||||0.1991|2-Sided|95.0|-0.62|0.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7|
1689960|NCT01122849|3107607|Superiority or Other||LS Mean difference|-1.8||||0.0009|2-Sided|95.0|-2.82|-0.78||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14|
1689961|NCT01122849|3107607|Superiority or Other||LS Mean difference|1.08||||0.0438|2-Sided|95.0|0.03|2.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 14|
1689962|NCT01122849|3107607|Superiority or Other||LS Mean Difference|-0.72||||0.1693|2-Sided|95.0|-1.75|0.32||Between treatment p-values and confidence intervals|ANCOVA|||Comparisons for Q4 at Day 14|
1689963|NCT01122849|3107607|Superiority or Other||LS mean Difference|0.41||||0.0786|2-Sided|95.0|-0.05|0.87|||ANCOVA|||Comparison for Q2 at Day 14|
1689964|NCT01122849|3107607|Superiority or Other||LS Mean Differnence|-0.35||||0.1356|2-Sided|95.0|-0.82|0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14|
1689965|NCT01122849|3107607|Superiority or Other||LS Mean Difference|0.06||||0.8063|2-Sided|95.0|-0.4|0.51||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 14|
1689966|NCT01122849|3107608|Superiority or Other||LS Mean difference|-1.57||||0.0011|2-Sided|95.0|-2.48|-0.66||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7|
1689967|NCT01122849|3107608|Superiority or Other||LS Mean difference|0.54||||0.2497|2-Sided|95.0|-0.39|1.47||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q4 at Day 7|
1689968|NCT01122849|3107608|Superiority or Other||LS mean differnence|-1.03||||0.0292||95.0|-1.96|-0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q4 at Day 7|
1689969|NCT01122849|3107608|Superiority or Other||LS Mean Difference|0.59||||0.0015|2-Sided|95.0|0.24|0.94||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7|
1689970|NCT01122849|3107608|Superiority or Other||LS Mean Difference|-0.32||||0.0815|2-Sided|95.0|-0.68|0.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7|
1689971|NCT01122849|3107608|Superiority or Other||LS Mean difference|0.27||||0.1345|2-Sided|95.0|-0.09|0.63||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q2 at Day 7|
1689972|NCT01122849|3107609|Superiority or Other||LS Mean Difference|7.16||||0.2313||95.0|-4.7|19.01||Between treatment p-values and confidence intervals|ANCOVA||||
1689973|NCT01122849|3107609|Superiority or Other||LS Mean Difference|0.63||||0.9183|2-Sided|95.0|-11.7|12.94||Between treatment p-values and confidence intervals|ANCOVA||||
1689974|NCT01122849|3107609|Superiority or Other||LS Mean Difference|7.79||||0.1764|2-Sided|95.0|-3.62|19.19||Between treatment p-values and confidence intervals|ANCOVA||||
1689975|NCT01122849|3107610|Superiority or Other||LS Mean Difference|11.5||||0.0259|2-Sided|95.0|1.44|21.55||Between treatment p-values and confidence intervals|ANCOVA||||
1689976|NCT01122849|3107610|Superiority or Other||LS Mean Difference|3.74||||0.4683|2-Sided|95.0|-6.53|14.01||Between treatment p-values and confidence intervals|ANCOVA||||
1689977|NCT01122849|3107610|Superiority or Other||LS Mean Difference|15.24||||0.0029|2-Sided|95.0|5.45|25.02||Between treatment p-values and confidence intervals|ANCOVA||||
1689978|NCT01122849|3107611|Superiority or Other||LS Mean difference|-19.37||||0.0046|2-Sided|95.0|-32.5|-6.23|||ANCOVA|Between treatment p-values and confidence intervals|||
1689979|NCT01122849|3107611|Superiority or Other||LS Mean Difference|14.28||||0.0385|2-Sided|95.0|0.79|27.77|||ANCOVA|Between treatment p-values and confidence intervals|||
1689980|NCT01122849|3107611|Superiority or Other||LS Mean Difference|-5.1||||0.4483|2-Sided|95.0|-18.5|8.29|||ANCOVA|Between treatment p-values and confidence intervals|||
1689981|NCT01122849|3107612|Superiority or Other||LS Mean Difference|-14.5||||0.037|2-Sided|95.0|-28.1|-0.91||Between treatment p-values and confidence intervals.|ANCOVA||||
1689982|NCT01122849|3107612|Superiority or Other||LS Mean Difference|10.14||||0.1458|2-Sided|95.0|-3.64|23.93||Between treatment p-values and confidence intervals|ANCOVA||||
1689983|NCT01122849|3107612|Superiority or Other||LS Mean Difference|-4.36||||0.5278|2-Sided|95.0|-18.1|9.39||Between treatment p-values and confidence intervals|ANCOVA||||
1689984|NCT01122849|3107613|Superiority or Other||LS Mean Difference|2.93||||0.0623|2-Sided|95.0|-0.16|6.02||Between treatment p-values and confidence intervals|ANCOVA||||
1689985|NCT01122849|3107613|Superiority or Other||LS Mean Difference|-1.81||||0.2607|2-Sided|95.0|-5.02|1.39||Between treatment p-values and confidence intervals|ANCOVA||||
1689986|NCT01122849|3107613|Superiority or Other||LS Mean Difference|1.12||||0.482|2-Sided|95.0|-2.05|4.29||Between treatment p-values and confidence intervals|ANCOVA||||
1689987|NCT01122849|3107614|Superiority or Other||LS Mean Difference|1.71||||0.2986|2-Sided|95.0|-1.56|4.97||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at Day 7|
1689988|NCT01122849|3107614|Superiority or Other||LS Mean Difference|-3.05||||0.0764|2-Sided|95.0|-6.43|0.33||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at Day 7|
1689989|NCT01122849|3107614|Superiority or Other||LS Mean difference|-1.34||||0.4258|2-Sided|95.0|-4.68|2.01||Between treatment p-values and confidence intervals|LS Mean Difference|||Comparison at Day 7|
1689990|NCT01122849|3107615|Superiority or Other||LS Mean difference|0.38||||0.6223|2-Sided|95.0|-1.17|1.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 14|
1689991|NCT01122849|3107615|Superiority or Other||LS Mean difference|0.15||||0.8454|2-Sided|95.0|-1.42|1.72||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 14|
1689992|NCT01122849|3107615|Superiority or Other||LS Mean difference|0.54||||0.4947|2-Sided|95.0|-1.03|2.1||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day14|
1689993|NCT01122849|3107615|Superiority or Other||LS Mean Difference|2.54||||0.0695|2-Sided|95.0|-0.21|5.29||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14|
1689994|NCT01122849|3107615|Superiority or Other||LS Mean difference|-2.68||||0.0614|2-Sided|95.0|-5.5|0.13||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14|
1689995|NCT01122849|3107615|Superiority or Other||LS Mean Difference|-0.14||||0.9183|2-Sided|95.0|-2.93|2.65||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 14|
1689996|NCT01122849|3107615|Superiority or Other||LS Mean Difference|1.7||||0.3136|2-Sided|95.0|-1.65|5.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep time problems at Day 14|
1689997|NCT01122849|3107615|Superiority or Other||LS Mean difference|0.28||||0.8677|2-Sided|95.0|-3.11|3.68|||ANCOVA|||Comparison for sleep time problems at Day 14|
1689998|NCT01122849|3107615|Superiority or Other||LS Mean difference|1.98||||0.2463|2-Sided|95.0|-1.41|5.36||Between treatment p-values and confidence intervals|ANCOVA|Between treatment p-values and confidence intervals||Comparison for Sleep time problems at Day 14|
1689999|NCT01122849|3107615|Superiority or Other||LS Mean Difference|1.89||||0.1739|2-Sided|95.0|-0.86|4.63||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 14|
1690000|NCT01122849|3107615|Superiority or Other||LS Mean Difference|-1.31||||0.3524|2-Sided|95.0|-4.12|1.49||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 14|
1690001|NCT01122849|3107615|Superiority or Other||LS Mean Difference|0.57||||0.6804|2-Sided|95.0|-2.2|3.35||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for Sleep Problems at Day 14|
1690002|NCT01122849|3107616|Superiority or Other||LS Mean difference|0.5||||0.5564|2-Sided|95.0|-1.19|2.18||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7|
1690003|NCT01122849|3107616|Superiority or Other||LS Mean difference|-0.8||||0.35|2-Sided|95.0|-2.51|0.9||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7|
1690004|NCT01122849|3107616|Superiority or Other||LS Mean difference|-0.3||||0.7211|2-Sided|95.0|-2.01|1.4||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for practical problems at Day 7|
1690005|NCT01122849|3107616|Superiority or Other||LS Mean Difference|3.12||||0.0298|2-Sided|95.0|0.32|5.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on waking in the morning at Day 7|
1690006|NCT01122849|3107616|Superiority or Other||LS Mean Difference|-3.83||||0.0099|2-Sided|95.0|-6.7|-0.96||Between treatment p-values and confidence intervals|ANCOVA|||Comparison at day 7 for symptoms for walking in the morning|
1690007|NCT01122849|3107616|Superiority or Other||LS Mean difference|-0.71||||0.6195|2-Sided|95.0|-3.55|2.14||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for symptoms on walking in the morning at Day 7|
1690008|NCT01122849|3107616|Superiority or Other||LS Mean difference|1.86||||0.2722|2-Sided|95.0|-1.5|5.21||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of sleep time problems at Day 7|
1690009|NCT01122849|3107616|Superiority or Other||LS Mean Difference|-2.57||||0.1354|2-Sided|95.0|-5.98|0.83||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Sleep time problems at Day 7|
1690010|NCT01122849|3107616|Superiority or Other||LS Mean difference|-0.72||||0.6731|2-Sided|95.0|-4.11|2.68||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Sleep Time problems at Day 7|
1690011|NCT01122849|3107616|Superiority or Other||LS Mean Difference|3.2||||0.0221|2-Sided|95.0|0.48|5.93||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of sleep problems at Day 7|
1690012|NCT01122849|3107616|Superiority or Other||LS Mean Difference|-2.37||||0.0942|2-Sided|95.0|-5.16|0.42||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison for sleep problems at Day 7|
1690013|NCT01122849|3107616|Superiority or Other||LS Mean Difference|0.84||||0.5462|2-Sided|95.0|-1.92|3.59||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for sleep problems at Day 7|
1690014|NCT01122849|3107617|Superiority or Other||LS Mean Difference|0.41||||0.0503|2-Sided|95.0|0.0|0.82||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q18 at Day 14|
1690015|NCT01122849|3107617|Superiority or Other||LS Mean difference|-0.49||||0.025|2-Sided|95.0|-0.91|-0.06||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day14|
1690016|NCT01122849|3107617|Superiority or Other||LS Mean Difference|-0.08||||0.7092|2-Sided|95.0|-0.5|0.34||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day 14|
1690017|NCT01122849|3107617|Superiority or Other||LS Mean Difference|0.35||||0.1061|2-Sided|95.0|-0.08|0.79||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14|
1690018|NCT01122849|3107617|Superiority or Other||LS Mean Difference|-0.48||||0.0337|2-Sided|95.0|-0.92|-0.04||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14|
1690019|NCT01122849|3107617|Superiority or Other||LS Mean Difference|-0.12||||0.575|2-Sided|95.0|-0.56|0.31||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q17 at Day 14|
1690020|NCT01122849|3107617|Superiority or Other||LS Mean Difference|0.39||||0.1375|2-Sided|95.0|-0.13|0.9||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q3 at Day 14|
1690021|NCT01122849|3107617|Superiority or Other||LS Mean Difference|-0.19||||0.4795|2-Sided|95.0|-0.71|0.34|||ANCOVA|||Comparison of Q3 at Day 14|
1690022|NCT01122849|3107617|Superiority or Other||LS Mean Difference|0.2||||0.4425||95.0|-0.32|0.72||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q3 at Day 14|
1690023|NCT01122849|3107617|Superiority or Other||LS Mean Difference|0.2||||0.3348|2-Sided|95.0|-0.21|0.62|||ANCOVA|||Comparison of Q1 at Day 14|
1690024|NCT01122849|3107617|Superiority or Other||LS Mean Difference|-0.31||||0.1429|2-Sided|95.0|-0.73|0.11||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 14|
1690025|NCT01122849|3107617|Superiority or Other||LS Mean Difference|-0.11||||0.5958|2-Sided|95.0|-0.52|0.3||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1at Day 14|
1690026|NCT01122849|3107618|Superiority or Other||LS Mean Difference|0.41||||0.0256|2-Sided|95.0|0.05|0.77||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q18 at Day 7|
1690027|NCT01122849|3107618|Superiority or Other||LS Mean Difference|-0.46||||0.0151|2-Sided|95.0|-0.83|-0.09|||ANCOVA|||Comparison of Q18 at Day 7|
1690028|NCT01122849|3107618|Superiority or Other||LS Mean Difference|-0.05||||0.7686|2-Sided|95.0|-0.42|0.31||Between treatment p-values and confidence intervals.|ANCOVA|||Comparison of Q18 at Day 7|
1690029|NCT01122849|3107618|Superiority or Other||LS Mean Difference|0.37||||0.0591|2-Sided|95.0|-0.01|0.76||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7|
1690030|NCT01122849|3107618|Superiority or Other||LS Mean Difference|-0.19||||0.3369|2-Sided|95.0|-0.58|0.2||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7|
1690031|NCT01122849|3107618|Superiority or Other||LS Mean Difference|0.18||||0.3553|2-Sided|95.0|-0.21|0.57||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q17 at Day 7|
1690032|NCT01122849|3107618|Superiority or Other||LS Mean Difference|0.3||||0.2364|2-Sided|95.0|-0.2|0.79|||ANCOVA|||Comparison for Q3 at Day 7|
1690033|NCT01122849|3107618|Superiority or Other||LS Mean difference|-0.24||||0.3457||95.0|-0.74|0.27||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q3 at Day 7|
1690034|NCT01122849|3107618|Superiority or Other||LS Mean Difference|0.06||||0.8213|2-Sided|95.0|-0.45|0.56||Between treatment p-values and confidence intervals|ANCOVA|||Comparison for Q3 at Day 7|
1690035|NCT01122849|3107618|Superiority or Other||LS mean difference|0.22||||0.2879|2-Sided|95.0|-0.19|0.62||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7|
1690036|NCT01122849|3107618|Superiority or Other||LS mean difference|-0.34||||0.1029|2-Sided|95.0|-0.75|0.07||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7|
1690037|NCT01122849|3107618|Superiority or Other||Least Square (LS) Mean difference|-0.12||||0.5456|2-Sided|95.0|-0.52|0.28||Between treatment p-values and confidence intervals|ANCOVA|||Comparison of Q1 at Day 7|
1690038|NCT01122680|3107632|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.04||||95.0|-0.088|0.069||||||Tio R2.5 minus Tio R1.25|
1690039|NCT01122680|3107632|Superiority or Other||Mean Difference (Final Values)|0.056|Standard Error of the Mean|0.036||||95.0|-0.014|0.126||||||Tio R5 minus Tio R2.5|
1690040|NCT01122680|3107632|Superiority or Other||Mean Difference (Final Values)|0.046|Standard Error of the Mean|0.039||||95.0|-0.031|0.124||||||Tio R5 minus Tio R1.25|
1690041|NCT01122680|3107632|Superiority or Other||Mean Difference (Final Values)|0.067|Standard Error of the Mean|0.036||0.0664||95.0|-0.005|0.138||This test is considered as descriptive.|Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R1.25 minus Placebo|
1690042|NCT01122680|3107632|Superiority or Other||Mean Difference (Final Values)|0.057|Standard Error of the Mean|0.039||0.1484||95.0|-0.021|0.135||Second step of closed testing procedure. If this statisical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed effect repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R2.5 minus Placebo|
1690043|NCT01122680|3107632|Superiority or Other||Mean Difference (Final Values)|0.113|Standard Error of the Mean|0.039||0.0043||95.0|0.036|0.19||First step of closed testing procedure, where the active treatments are compared to placebo. If this statisical test significant at the 0.05 alpha level then proceed to comparison of the next lower dose to placebo.|Mixed model repeated measures (MMRM)|This MMRM model includes treatment, period and baseline as fixed effects, and patient as a random effect.||Tio R5 minus Placebo|
1690044|NCT01122394|3107691|Superiority or Other|||||||0.12|||||||Regression, Linear||||
1690045|NCT01122394|3107692|Superiority or Other|||||||0.81|||||||Regression, Linear||||
1690046|NCT01122394|3107693|Superiority or Other|||||||0.11|||||||Wilcoxon (Mann-Whitney)||||
1690047|NCT01122394|3107694|Superiority or Other|||||||0.25|||||||Regression, Logistic|This analysis includes participants in pre-action and action/maintenance|||
1690048|NCT01122394|3107695|Superiority or Other|||||||0.29|||||||robust regression|controlling for provider clustering||Robust regressions were performed|
1690049|NCT01122264|3107714|Superiority or Other||Cox Proportional Hazard|1.32||||0.033|2-Sided|95.0|1.02|1.71||P-value: Tadalafil On Demand versus Tadalafil Once a Day treatment groups using Cox’s proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox||||
1690050|NCT01122264|3107714|Superiority or Other||Cox Proportional Hazard|0.49|||<|0.001|2-Sided|97.3|0.37|0.65||P-value: Tadalafil On Demand versus Sildenafil Citrate On Demand treatment groups. Cox’s proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox||||
1690051|NCT01122264|3107714|Superiority or Other||Cox Proportional Hazard|0.66|||<|0.001|2-Sided|97.3|0.51|0.85||P-value: Tadalafil Once a Day versus Sildenafil Citrate On Demand treatment groups. Cox’s proportional hazards model with factors for randomized treatment group, baseline International Index of Erectile Function-Erectile Function score, and country.|Regression, Cox||||
1690052|NCT01122238|3107715|Superiority or Other||Standardized Regression Coefficient|-0.04||||0.33|2-Sided||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.|
1690053|NCT01122238|3107715|Superiority or Other||Standardized Regression Coefficient|0.0||||0.99|2-Sided||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.|
1690054|NCT01122238|3107715|Superiority or Other||Standardized Regression Coefficient|-0.04||||0.4|2-Sided||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.|
1690078|NCT01122030|3107740|Superiority or Other||Hazard Ratio (HR)|3.45|||<|0.1523|2-Sided|95.0|0.62|19.35|||Log Rank|P-values are from the log rank test stratified by gender.|||
1690055|NCT01122238|3107715|Superiority or Other||Standardized Regression Coefficient|0.0||||0.98|2-Sided||||||Regression, Linear|||The linear regression model effects consisted of four treatment main effects, six two-way treatment interactions, four three-way treatment interactions, and one four-way interaction. Only the results for the treatment main effects are being reported in ClinicalTrials.gov.|
1690056|NCT01122238|3107716|Superiority or Other|||||||0.206|||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.|
1690057|NCT01122238|3107716|Superiority or Other|||||||0.536|||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.|
1690058|NCT01122238|3107716|Superiority or Other|||||||0.562|||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.|
1690059|NCT01122238|3107716|Superiority or Other|||||||0.665|||||||ANCOVA|The mean values tested and reported consist of residualized change scores from the ANCOVA.||The ANCOVA model included intervention main effects and intervention interactions plus baseline cigarettes per day, education, race, and time to first daily cigarette as covariates. Intervention main effects included Nicotine Patch vs. No Nicotine Patch; Nicotine Gum vs. No Nicotine Gum; Smoking Reduction vs. No Smoking Reduction; and Motivational Interviewing vs. No Motivational Interviewing.|
1690060|NCT01122108|3107723|Superiority or Other||||||<|0.05||||||If a sequence was not found to be statistically significant, then that term was removed from final model. Normality of residuals was investigated for each outcome variable using the Shapiro-Wilk test.|repeated measures analysis of variance|Sensitivity analyses were run to evaluate possible product by sequence interactions||"The BASA scale was previously developed to effectively compare differing Bile acid sequestrant forumulations. The BASA scale should differentiate subject acceptability of Colesevelam HCl 3.75 vs Cholestyramine 12g based upon the sum of ratings for taste, texture, appearance and mixability.~If normality hypothesis was rejected, then further inspection of the distribution utilizing normal quantile-quantile and kernel density plots was employed."|
1690061|NCT01122030|3107737|Superiority or Other|||||||0.0006|||||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|||
1690062|NCT01122030|3107737|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|||
1690063|NCT01122030|3107737|Superiority or Other||||||<|0.8714|||||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|||
1690064|NCT01122030|3107737|Superiority or Other||||||<|0.7342|||||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|||
1690065|NCT01122030|3107737|Superiority or Other||||||<|0.7159||||||P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|ANCOVA||||
1690066|NCT01122030|3107737|Superiority or Other||||||<|0.3441|||||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|||
1690067|NCT01122030|3107738|Superiority or Other|||||||0.0006|||||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|||
1690068|NCT01122030|3107738|Superiority or Other|||||||0.0001|||||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|||
1690069|NCT01122030|3107738|Superiority or Other|||||||0.9599|||||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|||
1690070|NCT01122030|3107738|Superiority or Other|||||||0.6963|||||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|||
1690071|NCT01122030|3107738|Superiority or Other|||||||0.9688|||||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|||
1690072|NCT01122030|3107738|Superiority or Other|||||||0.5054|||||||ANCOVA|P-values were obtained from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CBMs as a covariate.|||
1690073|NCT01122030|3107740|Superiority or Other||Hazard Ratio (HR)|10.99||||0.0007|2-Sided|95.0|2.3|52.57|||Log Rank|P-values are from the log rank test stratified by gender.|||
1690074|NCT01122030|3107740|Superiority or Other||Hazard Ratio (HR)|59.34|||<|0.0001|2-Sided|95.0|6.55|537.38|||Log Rank|P-values are from the log rank test stratified by gender.|||
1690075|NCT01122030|3107740|Superiority or Other||Hazard Ratio (HR)|0.86|||<|0.8594|2-Sided|95.0|0.09|8.66|||Log Rank|P-values are from the log rank test stratified by gender.|||
1690076|NCT01122030|3107740|Superiority or Other||Hazard Ratio (HR)|1.81|||<|0.5284|2-Sided|95.0|0.3|10.98|||Log Rank|P-values are from the log rank test stratified by gender.|||
1690077|NCT01122030|3107740|Superiority or Other||Hazard Ratio (HR)|4.55|||<|0.0856|2-Sided|95.0|0.76|27.07|||Log Rank|P-values are from the log rank test stratified by gender.|||
1690286|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-10.114|||||2-Sided|95.0|-25.12|4.89|||||Day 14, 24 Hours||
1690079|NCT01122030|3107741|Superiority or Other||Hazard Ratio (HR)|192233779.0|||<|0.0001||95.0|||||Log Rank|P-values are from the log rank test stratified by gender.|Hazard Ratio is infinite due to small range of observed times in 3 mg group that has no overlap with the Placebo group.||
1690080|NCT01122030|3107741|Superiority or Other||Hazard Ratio (HR)|9.54|||<|0.0001|2-Sided|95.0|3.0|30.35|||Log Rank|P-values are from the log rank test stratified by gender.|||
1690081|NCT01122030|3107741|Superiority or Other||Hazard Ratio (HR)|7.36|||<|0.0005|2-Sided|95.0|2.27|23.9|||Log Rank|P-values are from the log rank test stratified by gender.|||
1690082|NCT01122030|3107741|Superiority or Other||Hazard Ratio (HR)|1.44|||<|0.506|2-Sided|95.0|0.56|3.67|||Log Rank|P-values are from the log rank test stratified by gender.|||
1690083|NCT01122030|3107741|Superiority or Other||Hazard Ratio (HR)|1.45|||<|0.5479|2-Sided|95.0|0.52|4.06|||Log Rank|P-values are from the log rank test stratified by gender.|||
1690084|NCT01122030|3107741|Superiority or Other||Hazard Ratio (HR)|1.51|||<|0.4923|2-Sided|95.0|0.53|4.28|||Log Rank|P-values are from the log rank test stratified by gender.|||
1690085|NCT01122030|3107742|Superiority or Other||Hazard Ratio (HR)|0.0|||<|0.0001||95.0|||||Log Rank|P-values were obtained from the log-rank test stratified by Gender.|Hazard Ratio is infinite due to small range of observed times in 3 mg group that has no overlap with the Placebo group.||
1690086|NCT01122030|3107742|Superiority or Other||Hazard Ratio (HR)|9.93|||<|0.0001|2-Sided|95.0|3.09|31.89|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.|||
1690087|NCT01122030|3107742|Superiority or Other||Hazard Ratio (HR)|7.52|||<|0.0005|2-Sided|95.0|2.29|24.72|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.|||
1690088|NCT01122030|3107742|Superiority or Other||Hazard Ratio (HR)|0.86|||<|0.8129|2-Sided|95.0|0.27|2.72|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.|||
1690089|NCT01122030|3107742|Superiority or Other||Hazard Ratio (HR)|1.54|||<|0.4449|2-Sided|95.0|0.54|4.42|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.|||
1690090|NCT01122030|3107742|Superiority or Other||Hazard Ratio (HR)|1.29|||<|0.7434|2-Sided|95.0|0.42|3.92|||Log Rank|P-values were obtained from the log-rank test stratified by Gender.|||
1690091|NCT01122030|3107743|Superiority or Other|||||||0.0018|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.|||
1690092|NCT01122030|3107743|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.|||
1690093|NCT01122030|3107743|Superiority or Other||||||<|0.7674|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.|||
1690094|NCT01122030|3107743|Superiority or Other||||||<|0.799|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.|||
1690095|NCT01122030|3107743|Superiority or Other||||||<|0.9293|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.|||
1690096|NCT01122030|3107743|Superiority or Other||||||<|0.6131|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.|||
1690097|NCT01122030|3107744|Superiority or Other|||||||0.0002|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.|||
1690098|NCT01122030|3107744|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.|||
1690099|NCT01122030|3107744|Superiority or Other||||||<|0.8708|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.|||
1690100|NCT01122030|3107744|Superiority or Other||||||<|0.1968|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.|||
1690101|NCT01122030|3107744|Superiority or Other||||||<|0.7456|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.|||
1690102|NCT01122030|3107744|Superiority or Other||||||<|0.6269|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of CSBMs as a covariate.|||
1690103|NCT01122030|3107745|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.|||
1690104|NCT01122030|3107745|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.|||
1690105|NCT01122030|3107745|Superiority or Other||||||<|0.0283|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.|||
1690106|NCT01122030|3107745|Superiority or Other||||||<|0.7531|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.|||
1690107|NCT01122030|3107745|Superiority or Other||||||<|0.7143|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.|||
1690108|NCT01122030|3107745|Superiority or Other||||||<|0.7978|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.|||
1690109|NCT01122030|3107746|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.|||
1690110|NCT01122030|3107746|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.|||
1690111|NCT01122030|3107746|Superiority or Other||||||<|0.0002|||||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.|||
1690112|NCT01122030|3107746|Superiority or Other||||||<|0.9371|||||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.|||
1690113|NCT01122030|3107746|Superiority or Other||||||<|0.332|||||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.|||
1690114|NCT01122030|3107746|Superiority or Other||||||<|0.1334|||||||ANCOVA|P-value is from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of BMs as a covariate.|||
1690115|NCT01122030|3107747|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.|||
1690116|NCT01122030|3107747|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.|||
1690117|NCT01122030|3107747|Superiority or Other||||||<|0.0047|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.|||
1690118|NCT01122030|3107747|Superiority or Other||||||<|0.9301|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.|||
1690119|NCT01122030|3107747|Superiority or Other||||||<|0.4946|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.|||
1690120|NCT01122030|3107747|Superiority or Other||||||<|0.8982|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.|||
1690121|NCT01122030|3107748|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.|||
1690122|NCT01122030|3107748|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.|||
1690123|NCT01122030|3107748|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.|||
1690124|NCT01122030|3107748|Superiority or Other||||||<|0.6373|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.|||
1690125|NCT01122030|3107748|Superiority or Other||||||<|0.8727|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.|||
1690126|NCT01122030|3107748|Superiority or Other||||||<|0.0767|||||||ANCOVA|P-values are from a non-parametric rank ANCOVA model with effects for dose group and gender, and baseline number of SBMs as a covariate.|||
1690127|NCT01121926|3107768|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUCss is between 80% and 125%.|Mean ratio|85.72|||||2-Sided|90.0|81.05|90.67|||||Test/reference (%)||
1690128|NCT01121926|3107769|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax,ss is between 80% and 125%.|Mean ratio|56.53|||||2-Sided|90.0|49.99|63.94|||||Test/reference (%)||
1690129|NCT01121913|3107773|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|67.7|||||2-Sided|90.0|58.4|78.5|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®||
1690130|NCT01121913|3107773|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|83.0|||||2-Sided|90.0|71.5|96.4|||||Trazodone Contramid® OAD (prototype 2)/Triticco®||
1690131|NCT01121913|3107773|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|59.8|||||2-Sided|90.0|51.5|69.4|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®||
1690132|NCT01121913|3107773|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 75% and 133%.|Mean ratio|73.3|||||2-Sided|90.0|63.2|85.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®||
1690133|NCT01121913|3107774|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|98.4|||||2-Sided|90.0|88.3|110.0|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®||
1690134|NCT01121913|3107774|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|94.9|||||2-Sided|90.0|85.1|106.0|||||Trazodone Contramid® OAD (prototype 2)/Triticco®||
1690135|NCT01121913|3107774|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|106.0|||||2-Sided|90.0|95.1|118.0|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®||
1690259|NCT01120184|3108176|Superiority or Other||Difference in Response Rate|2.9|||||2-Sided|95.0|-4.5|10.3|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo||
1690136|NCT01121913|3107774|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|102.0|||||2-Sided|90.0|91.8|114.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®||
1690137|NCT01121913|3107775|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|97.7|||||2-Sided|90.0|87.7|109.0|||||Trazodone Contramid® OAD (prototype 2)/Desyrel®||
1690138|NCT01121913|3107775|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|95.3|||||2-Sided|90.0|85.5|106.0|||||Trazodone Contramid® OAD (prototype 2)/Triticco®||
1690139|NCT01121913|3107775|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|105.0|||||2-Sided|90.0|93.9|117.0|||||Trazodone Contramid® OAD (prototype 1)/Desyrel®||
1690140|NCT01121913|3107775|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-t) is between 80% and 125%.|Mean ratio|102.0|||||2-Sided|90.0|91.8|114.0|||||Trazodone Contramid® OAD (prototype 1)/Triticco®||
1690141|NCT01121900|3107780|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-∞) is between 80% and 125%.|Mean ratio|83.5|||||2-Sided|90.0|76.5|91.1|||||Test/reference (%)||
1690142|NCT01121900|3107781|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC(0-tlast) is between 80% and 125%.|Mean ratio|80.9|||||2-Sided|90.0|74.2|88.3|||||Test/reference (%)||
1690143|NCT01121900|3107782|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LSmeans) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax is between 80% and 125%.|Mean ratio|39.8|||||2-Sided|90.0|34.4|46.0|||||Test/reference (%)||
1690144|NCT01121666|3107796|Non-Inferiority or Equivalence|This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.||||||0.0003|||||||Shuirmann’s TOST||||
1690145|NCT01121666|3107803|Superiority or Other|||||||0.8926|||||||Wilcoxon (Mann-Whitney)||||
1690146|NCT01121666|3107808|Superiority or Other|||||||0.9638|||||||Wilcoxon (Mann-Whitney)||||
1690147|NCT01121666|3107810|Superiority or Other|||||||0.3992||||||Follicles of 17 mm|Wilcoxon (Mann-Whitney)||||
1690148|NCT01121666|3107810|Superiority or Other|||||||0.1395||||||Follicles of 15 mm|Wilcoxon (Mann-Whitney)||||
1690149|NCT01121666|3107810|Superiority or Other|||||||0.2357||||||Follicles of 12 mm|Wilcoxon (Mann-Whitney)||||
1690150|NCT01121666|3107811|Non-Inferiority or Equivalence|This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.||||||0.0003||||||This study was powered to test equivalence using a two one-sided test (TOST) with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.|Shuirmann’s TOST|||This study was powered to test equivalence using a two one-sided test (TOST) of the number of oocytes retrieved.|
1690151|NCT01121575|3107814|Superiority or Other||Ratio of adjust geometric mean|130.57|||||2-Sided|90.0|82.46|206.73|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib Cmax for participants who had both Day -1 and C2D1 data. Result for the analysis of Cmax was based on data from 3 participants. No statistical analysis was performed for PF-05199265.|
1690152|NCT01121575|3107816|Superiority or Other||Ratio of adjust geometric mean|121.9|||||2-Sided|90.0|70.2|211.66|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib AUC24 for participants who had both Day -1 and C2D1 data. Result for the analysis of AUC24 was based on data from 3 participants. No statistical analysis was performed for PF-05199265.|
1690153|NCT01121575|3107817|Superiority or Other||Ratio of adjust geometric mean|117.81|||||2-Sided|90.0|64.97|213.61|||||Ratio of crizotinib + dacomitinib / dacomitinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for dacomitinib AUClast for participants who had both Day -1 and C2D1 data. Result for the analysis of AUClast was based on data from 3 participants. No statistical analysis was performed for PF-05199265.|
1690154|NCT01121575|3107820|Superiority or Other||Ration of adjust geometric mean|70.6|||||2-Sided|90.0|54.71|91.12|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib Cmax for participants who had both Day -1 and C2D1 data. Result for the analysis of Cmax was based on data from 11 participants. No statistical analysis was performed for PF-06260182.|
1690155|NCT01121575|3107822|Superiority or Other||Ratio of adjust geometric mean|78.84|||||2-Sided|90.0|58.9|105.54|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib AUC10 for participants who had both Day -1 and C2D1 data. Result for the analysis of AUC10 was based on data from 6 participants. No statistical analysis was performed for PF-06260182.|
1690156|NCT01121575|3107823|Superiority or Other||Ratio of adjust geometric mean|69.25|||||2-Sided|90.0|54.22|88.44|||||Ratio of crizotinib + dacomitinib / crizotinib alone adjust geometric mean was analyzed using the mixed effect model and displayed as percentage.|Statistical analysis was performed for crizotinib AUClast for participants who had both Day -1 and C2D1 data. Result for the analysis of AUClast was based on data from 11 participants. No statistical analysis was performed for PF-06260182.|
1690157|NCT01121484|3107884|Superiority or Other||||||<|0.001||||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA||||
1690158|NCT01121484|3107885|Superiority or Other|||||||0.158||||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA||||
1690159|NCT01121484|3107886|Superiority or Other|||||||0.002||||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA||||
1690160|NCT01121484|3107887|Superiority or Other|||||||0.002||||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA||||
1690161|NCT01121484|3107888|Superiority or Other||||||<|0.001||||||CGI-I analyzed as a categorical variable by Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores, controlling for the effect of region; p-value obtained from the alternative hypothesis of Row Mean Score Differences.|Cochran-Mantel-Haenszel||||
1690162|NCT01121484|3107889|Superiority or Other|||||||0.004||||||Analysis of Covariance used change from baseline at Week 8 as a response variable, site and treatment as factors, and baseline score as a covariate.|ANCOVA|||Null hypothesis: no difference between treatment groups|
1690163|NCT01121406|3107906|Superiority or Other||Hazard Ratio (HR)|0.27|||||2-Sided|95.0|0.09|0.77|||||"Cox proportional−hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"||
1690164|NCT01121406|3107907|Superiority or Other||Hazard Ratio (HR)|0.69|||||2-Sided|95.0|0.33|1.47|||||"Cox proportional−hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"||
1690165|NCT01121406|3107908|Superiority or Other||Hazard Ratio (HR)|0.86|||||2-Sided|95.0|0.39|1.93|||||"Cox proportional−hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"||
1690166|NCT01121406|3107909|Superiority or Other||Hazard Ratio (HR)|0.78|||||2-Sided|95.0|0.37|1.65|||||"Cox proportional−hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"||
1690167|NCT01121406|3107910|Superiority or Other||Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.4|1.61|||||"Cox proportional−hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"||
1690168|NCT01121406|3107911|Superiority or Other||Hazard Ratio (HR)|1.12|||||2-Sided|95.0|0.73|1.7|||||"Cox proportional−hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727)/ Cytotoxic"||
1690169|NCT01121406|3107914|Superiority or Other||Hazard Ratio (HR)|0.94|||||2-Sided|95.0|0.63|1.42|||||"Cox proportional−hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727) /Cytotoxic"||
1690170|NCT01121406|3107915|Superiority or Other||Hazard Ratio (HR)|1.01|||||2-Sided|95.0|0.66|1.53|||||"Cox proportional−hazards regression model, stratified by disease status at baseline (measurable vs. non measurable disease) and platinum resistant vs platinum refractory disease at baseline.~HR calculated as Volasertib (BI 6727) /Cytotoxic"||
1690171|NCT01121406|3107916|Superiority or Other||Difference in Kaplan−Meier DC rates|-12.5|||||2-Sided|95.0|-31.1|6.0|||||"95% CI using Greenwood´s variance estimate.~Volasertib (BI 6727) minus Cytotoxic."|Kaplan Meier estimates and confidence intervals (CI) were calculated using Greenwood’s variance estimate within each treatment arm and the asymptotic CI for the difference in the rates found. The time was censored in those cases where there was no death or progression until the last trial visit|
1690172|NCT01121393|3107922|Superiority||Hazard Ratio (HR)|0.699|||||2-Sided|95.0|0.511|0.956||||||Cox proportional hazard model stratified by EGFR mutation group|
1690173|NCT01121393|3107922|Superiority|||||||0.022|||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.|
1690174|NCT01121393|3107923|Superiority||Hazard Ratio (HR)|0.534|||||2-Sided|95.0|0.394|0.724||||||Cox proportional hazard model stratified by EGFR mutation group|
1690175|NCT01121393|3107923|Superiority||||||<|0.0001|||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.|
1690176|NCT01121393|3107924|Superiority||Hazard Ratio (HR)|0.458|||||2-Sided|95.0|0.303|0.692||||||Cox proportional hazard model stratified by EGFR mutation group|
1690177|NCT01121393|3107924|Superiority|||||||0.0001|||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on HRQOL compared with gemcitabine / cisplatin chemotherapy.|
1690178|NCT01121393|3107927|Superiority||Mean Difference (Final Values)|-13.64|Standard Error of the Mean|1.76|<|0.0001|2-Sided|95.0|-17.1|-10.19|||ANCOVA|adjusted for baseline sum of diameters and EGFR mutation group|||
1690179|NCT01121393|3107931|Superiority||Hazard Ratio (HR)|0.904|||||2-Sided|95.0|0.715|1.144||||||A Cox proportional hazard model stratified (by EGFR mutation category stratification factor used at randomisation) was used to test the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.|
1690180|NCT01121393|3107931|Superiority|||||||0.4013|||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on OS compared with gemcitabine / cisplatin chemotherapy.|
1690181|NCT01121393|3107932|Superiority||Odds Ratio (OR)|3.843|||<|0.0001|2-Sided|95.0|2.039|7.24|||Regression, Logistic|||stratified for EGFR mutation group|
1690182|NCT01121393|3107933|Superiority||Odds Ratio (OR)|7.572|||<|0.0001|2-Sided|95.0|4.522|12.679|||Regression, Logistic|||A logistic regression model, stratified by EGFR mutation category was used to compare the objective response rate between the 2 treatment arms.|
1690183|NCT01121393|3107934|Superiority||Hazard Ratio (HR)|0.281|||||2-Sided|95.0|0.203|0.389||||||A Cox proportional-hazards model, stratified by EGFR mutation category was used to estimate the hazard ratio (HR) and 95% confidence interval (CI) between the 2 treatment arms.|
1690184|NCT01121393|3107934|Superiority||||||<|0.0001|||||||Log Rank|||A stratified log-rank test (by the epidermal growth factor receptor (EGFR) mutation category stratification factor used at randomisation) was used to test for the effect of afatinib on PFS compared with gemcitabine / cisplatin chemotherapy.|
1690185|NCT01121263|3107935|Superiority or Other||Hazard Ratio (HR)|0.868||||0.53||95.0|0.556|1.355|||Regression, Cox||The Cox proportional hazards regression model was weighted by the propensity score to account for the difference in baseline risk between groups.|This applies to any MACCE|
1690186|NCT01121263|3107936|Superiority or Other||Hazard Ratio (HR)|1.063||||0.8||95.0|0.666|1.697|||Regression, Cox|The Cox proportional hazards regression model was weighted by propensity score to adjust for differences in baseline risk between the two groups.|The Cox model was weighted by propensity score to adjust for differences in baseline risk between the two groups.|This applies to any MACCE|
1690187|NCT01121172|3107977|Superiority or Other|||||||0.232|||||||Chi-squared|Chi-square test of frequency distribution amng obese study group and HapMap-CEU polymorphism distribution|||
1690188|NCT01121172|3107978|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Non parametric test|||
1690189|NCT01120704|3108016|Superiority or Other||Odds Ratio (OR)|1.09||||0.514|2-Sided|95.0|0.842|1.411|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls) would result in significantly higher abstinence at 52 weeks after target quit day.|
1690190|NCT01120704|3108016|Superiority or Other||Odds Ratio (OR)|0.852||||0.205|2-Sided|95.0|0.664|1.092|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback) would result in significantly higher abstinence at 52 weeks after target quit day.|
1690191|NCT01120704|3108016|Superiority or Other||Odds Ratio (OR)|1.018||||0.885|2-Sided|95.0|0.797|1.301|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.|
1690192|NCT01120704|3108016|Superiority or Other||Odds Ratio (OR)|1.008||||0.956|2-Sided|95.0|0.769|1.321|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Maintenance Counseling vs. Maintenance Counseling) would result in significantly higher abstinence at 52 weeks after target quit day.|
1690193|NCT01120704|3108016|Superiority or Other||Odds Ratio (OR)|1.402||||0.011|2-Sided|95.0|1.08|1.821|||Regression, Logistic|||The logistic regression model effects consisted of five treatment main effects and all treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., 8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum) would result in significantly higher abstinence at 52 weeks after target quit day.|
1690194|NCT01120704|3108017|Superiority or Other||Cox Proportional Hazard|0.945||||0.248|2-Sided|95.0|0.858|1.04|||Regression, Cox||||
1690195|NCT01120704|3108017|Superiority or Other||Cox Proportional Hazard|0.954||||0.339|2-Sided|95.0|0.867|1.05|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).|
1690196|NCT01120704|3108017|Superiority or Other||Cox Proportional Hazard|1.044||||0.382|2-Sided|95.0|0.948|1.149|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).|
1690197|NCT01120704|3108017|Superiority or Other||Cox Proportional Hazard|0.982||||0.705|2-Sided|95.0|0.892|1.081|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).|
1690198|NCT01120704|3108017|Superiority or Other||Cox Proportional Hazard|0.906||||0.045|2-Sided|95.0|0.822|0.998|||Regression, Cox|||The Cox regression model effects consisted of five treatment effects, 10 two-way treatment interactions, 10 three-way treatment interactions, and two covariates : two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).|
1690260|NCT01120184|3108176|Superiority or Other||Difference in Response Rate|-1.8|||||2-Sided|95.0|-9.2|5.7|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane||
1690612|NCT01118455|3108496|Superiority or Other|||||||0.295|||||||ANOVA||||
1690199|NCT01120600|3108045|Superiority or Other||Difference in Least Squares Means|-16.0|||=|0|2-Sided|95.0|-25.74|-6.27|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.|
1690200|NCT01120600|3108046|Superiority or Other||Difference in Least Squares Means|-7.94|||=|0|2-Sided|95.0|-14.58|-1.31|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.|
1690201|NCT01120600|3108047|Superiority or Other||Difference in Least Squares Means|-68.08|||<|0.001|2-Sided|95.0|-78.1|-58.06|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.|
1690202|NCT01120600|3108048|Superiority or Other||Difference in Least Squares Means|-76.58|||<|0.001|2-Sided|95.0|-92.56|-60.61|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.|
1690203|NCT01120600|3108049|Superiority or Other||Difference in Least Squares Means|2.12|||<|0.001|2-Sided|95.0|0.93|3.3|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.|
1690204|NCT01120600|3108050|Superiority or Other||Difference in Least Squares Means|1.69|||=|0|2-Sided|95.0|0.45|2.93|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.|
1690205|NCT01120600|3108051|Superiority or Other||Difference in Least Squares Means|2.02|||<|0.001|2-Sided|95.0|1.27|2.77|||cLDA|||A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.|
1690206|NCT01120600|3108052|Superiority or Other||Difference in Least Squares Means|5.59|||<|0.001|2-Sided|95.0|4.48|6.7|||cLDA|||A constrained full likelihood longitudinal data analysis (cLDA) method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type–by-time interaction.|
1690207|NCT01120405|3108058|Superiority or Other||Difference of proportion|1.69||||0.6056|2-Sided|95.0|-4.74|8.13|||Difference of proportion||||
1690208|NCT01120405|3108060|Superiority or Other||Difference of proportion|0.68||||0.1559|2-Sided|95.0|-0.26|1.61|||Difference of proportion||||
1690209|NCT01120405|3108061|Superiority or Other||Difference of proportion|-0.34||||0.6533|2-Sided|95.0|-1.82|1.14|||Difference of proportion||||
1690210|NCT01120405|3108062|Superiority or Other||Difference of proportion|0.68||||0.4763|2-Sided|95.0|-1.19|2.54|||Difference of proportion||||
1690211|NCT01120405|3108063|Superiority or Other||Difference of proportion|0.68||||0.7715|2-Sided|95.0|-3.9|5.25|||Difference of proportion||||
1690212|NCT01120405|3108064|Non-Inferiority or Equivalence|Non-inferiority of xenon over sevoflurane is accepted if the upper bound of the two-sided 95% CI around the estimated difference is below the prespecified non-inferiority margin of 10%.|Difference of proportion|0.19||||0.0052|2-Sided|95.0|-6.7|7.07|||Difference of proportion|||"The percentage of patients with MN during the 3 postoperative days in the sevoflurane group and in the xenon group was expected to be 20%. The margin of non-inferiority was 10%. Thus the sample size to prove non-inferiority was 252 patients per group with α = 0.025, a power of 0.80 and the following hypotheses: H0: Px-Pc ≥ 10%; H1: Px-Pc < 10%.~As it was expected that approximately 15% of patients would be non-evaluable, a total of 600 patients were included."|
1690213|NCT01120275|3108100|Superiority or Other||1-year OS|0.5|||||2-Sided|95.0|0.32|0.66||||||1-year overall survival (OS) was estimated using the method of Kaplan-Meier and confidence intervals were calculated using the log-log transformation.|
1690214|NCT01120275|3108101|Superiority or Other||6-month PFS|0.09|||||2-Sided|95.0|0.02|0.22||||||6-month progression free survival (PFS) was estimated using the method of Kaplan-Meier and confidence intervals were calculated using the log-log transformation.|
1690215|NCT01120236|3108109|Superiority or Other||Risk Ratio (RR)|0.82||||0.11|2-Sided||||||Fisher Exact||Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.|Proportion of patients in each arm with PSA > 4 ng/mL after seven cycles of protocol treatment were compared.|
1690216|NCT01120236|3108111|Superiority or Other||Risk Ratio (RR)|1.24||||0.16|2-Sided||||||Fisher Exact||Arm I (Androgen Deprivation and Cixutumumab) represents the numerator and Arm II (Androgen Deprivation Therapy) represents the denominator for relative risk.|An intention-to-treat approach was used in analysis of the primary endpoint. A 45% undetectable PSA <= 0.2 ng/mL rate at 28 weeks was assumed for (control) arm II , based on data from SWOG 9346. Using a one-sided type I error rate of 0.10, we had 90% statistical power to detect an absolute difference of 20% in the undetectable PSA rate with the addition of cixutumumab using Fisher's exact test.|
1690261|NCT01120184|3108176|Superiority or Other||Difference in Response Rate|-4.6|||||2-Sided|95.0|-12.1|2.8|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane||
1690217|NCT01120210|3108137|Superiority or Other||Mean Difference (Final Values)|-527.77||||0.0001|2-Sided|95.0|-764.07|-291.478||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 30 ng/kg/min dose.|
1690218|NCT01120210|3108137|Superiority or Other||Mean Difference (Final Values)|-383.32||||0.0006|2-Sided|95.0|-592.781|-173.867||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 15 ng/kg/min dose.|
1690219|NCT01120210|3108137|Superiority or Other||Mean Difference (Final Values)|-264.36||||0.051|2-Sided|95.0|-529.875|1.147||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SVR at the end of the 5 ng/kg/min dose.|
1690220|NCT01120210|3108138|Superiority or Other||Mean Difference (Final Values)|-0.73||||0.6658|2-Sided|95.0|-4.138|2.669||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 30 ng/kg/min dose.|
1690221|NCT01120210|3108138|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.842|2-Sided|95.0|-3.851|3.153||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 15 ng/kg/min dose.|
1690222|NCT01120210|3108138|Superiority or Other||Mean Difference (Final Values)|0.7||||0.6304|2-Sided|95.0|-2.197|3.588||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PADP at the end of the 5 ng/kg/min dose.|
1690223|NCT01120210|3108139|Superiority or Other||Mean Difference (Final Values)|1.02||||0.6904|2-Sided|95.0|-4.107|6.148||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PASP at the end of the 30 ng/kg/min dose.|
1690224|NCT01120210|3108139|Superiority or Other||Mean Difference (Final Values)|-0.99||||0.6665|2-Sided|95.0|-5.567|3.594||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 15 ng/kg/min dose.|
1690225|NCT01120210|3108139|Superiority or Other||Mean Difference (Final Values)|-1.38||||0.4841|2-Sided|95.0|-5.308|2.554||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in PASP at the end of the 5 ng/kg/min dose.|
1690226|NCT01120210|3108140|Superiority or Other||Mean Difference (Final Values)|14.16||||0.018|2-Sided|95.0|2.557|25.771||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 30 ng/kg/min dose.|
1690227|NCT01120210|3108140|Superiority or Other||Mean Difference (Final Values)|8.78||||0.1083|2-Sided|95.0|-2.016|19.575||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 15 ng/kg/min dose.|
1690228|NCT01120210|3108140|Superiority or Other||Mean Difference (Final Values)|7.08||||0.2123|2-Sided|95.0|-4.198|18.359||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in SV at the end of the 5 ng/kg/min dose.|
1690229|NCT01120210|3108141|Superiority or Other||Mean Difference (Final Values)|0.95||||0.3748|2-Sided|95.0|-1.204|3.102||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in FS at the end of the 30 ng/kg/min dose.|
1690230|NCT01120210|3108142|Superiority or Other||Mean Difference (Final Values)|0.31||||0.865|2-Sided|95.0|-3.352|3.968||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in LVEF at the end of the 30 ng/kg/min dose.|
1690231|NCT01120210|3108143|Superiority or Other||Mean Difference (Final Values)|1.98||||0.8297|2-Sided|95.0|-16.592|20.551||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in LVEDV at the end of the 30 ng/kg/min dose.|
1690232|NCT01120210|3108144|Superiority or Other||Mean Difference (Final Values)|0.24||||0.9769|2-Sided|95.0|-16.347|16.823||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in left ventricular end systolic volume (LVESV) at the end of the 30 ng/kg/min dose.|
1690233|NCT01120210|3108145|Superiority or Other||Mean Difference (Final Values)|-7.08||||0.0043|2-Sided|95.0|-11.818|-2.332||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 30 ng/kg/min dose.|
1690234|NCT01120210|3108145|Superiority or Other||Mean Difference (Final Values)|-5.55||||0.0282|2-Sided|95.0|-10.482|-0.622||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 15 ng/kg/min dose.|
1690235|NCT01120210|3108145|Superiority or Other||Mean Difference (Final Values)|-3.36||||0.1561||95.0|-8.047|1.331||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in diastolic blood pressure (DBP) at the end of the 5 ng/kg/min dose.|
1690236|NCT01120210|3108146|Superiority or Other||Mean Difference (Final Values)|-3.77||||0.3152|2-Sided|95.0|-11.251|3.708||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 30 ng/kg/min dose.|
1690237|NCT01120210|3108146|Superiority or Other||Mean Difference (Final Values)|-1.99||||0.4923|2-Sided|95.0|-7.781|3.801||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 15 ng/kg/min dose.|
1690238|NCT01120210|3108146|Superiority or Other||Mean Difference (Final Values)|-0.67||||0.803|2-Sided|95.0|-6.06|4.718||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in systolic blood pressure (SBP) at the end of the 5 ng/kg/min dose.|
1690239|NCT01120210|3108147|Superiority or Other||Mean Difference (Final Values)|2.16||||0.1811|2-Sided|95.0|-1.046|5.372||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 30 ng/kg/min dose.|
1690240|NCT01120210|3108147|Superiority or Other||Mean Difference (Final Values)|1.24||||0.4107|2-Sided|95.0|-1.764|4.235||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 15 ng/kg/min dose.|
1690241|NCT01120210|3108147|Superiority or Other||Mean Difference (Final Values)|-0.32||||0.7682|2-Sided|95.0|-2.527|1.879||two-sided p-value and two-sided alpha=0.05|ANCOVA|||95% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in heart rate (HR) at the end of the 5 ng/kg/min dose.|
1690242|NCT01120210|3108148|Superiority or Other||Mean Difference (Final Values)|-2.58||||0.0821|2-Sided|90.0|-5.639|0.483||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 30 ng/kg/min dose.|
1690243|NCT01120210|3108148|Superiority or Other||Mean Difference (Final Values)|-1.35||||0.2123|2-Sided|90.0|-4.164|1.464||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 15 ng/kg/min dose.|
1690244|NCT01120210|3108148|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.4729|2-Sided|90.0|-2.312|2.131||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in pulmonary capillary wedge pressure (PCWP) at the end of the 5 ng/kg/min dose.|
1690245|NCT01120210|3108149|Superiority or Other||Mean Difference (Final Values)|0.57||||0.0049|2-Sided|90.0|0.214|0.921||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 30 ng/kg/min dose.|
1690246|NCT01120210|3108149|Superiority or Other||Mean Difference (Final Values)|0.33||||0.0215|2-Sided|90.0|0.064|0.595||one-sided p-value and one-sided alpha=0.05|ANCOVA|||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 15 ng/kg/min dose.|
1690247|NCT01120210|3108149|Superiority or Other||Mean Difference (Final Values)|0.27||||0.0595|2-Sided|90.0|-0.016|0.564|||ANCOVA|one-sided p-value and one-sided alpha=0.05||90% confidence intervals and p values represent the placebo-subtracted LS mean change from baseline in cardiac index (CI) at the end of the 5 ng/kg/min dose.|
1690248|NCT01120184|3108160|Superiority or Other||Hazard Ratio (HR)|1.0|||||2-Sided|97.5|0.74|1.34|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane||
1690249|NCT01120184|3108162|Superiority or Other||Hazard Ratio (HR)|0.9|||||2-Sided|97.5|0.65|1.25|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane||
1690250|NCT01120184|3108164|Superiority or Other||Odds Ratio (OR)|0.66|||||2-Sided|95.0|0.41|1.07|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane||
1690251|NCT01120184|3108165|Superiority or Other||Odds Ratio (OR)|0.67|||||2-Sided|95.0|0.4|1.15|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane||
1690252|NCT01120184|3108169|Superiority or Other||Hazard Ratio (HR)|0.68|||||2-Sided|95.0|0.55|0.84|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690253|NCT01120184|3108169|Superiority or Other||Hazard Ratio (HR)|0.7|||||2-Sided|95.0|0.57|0.86|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690254|NCT01120184|3108173|Superiority or Other||Difference in Symptom Rate|8.0|||||2-Sided|95.0|-2.3|18.4|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690255|NCT01120184|3108173|Superiority or Other||Difference in Symptom Rate|-24.2|||||2-Sided|95.0|-32.0|-16.0|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690256|NCT01120184|3108173|Superiority or Other||Difference in Symptom Rate|-32.2|||||2-Sided|95.0|-40.0|-24.0|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690257|NCT01120184|3108175|Superiority or Other||Hazard Ratio (HR)|0.62|||||2-Sided|97.5|0.45|0.85|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690258|NCT01120184|3108175|Superiority or Other||Hazard Ratio (HR)|0.6|||||2-Sided|97.5|0.43|0.84|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690613|NCT01118455|3108496|Superiority or Other|||||||0.343|||||||ANOVA||||
1690262|NCT01120184|3108177|Superiority or Other||Difference in Response Rate|4.5|||||2-Sided|95.0|-3.3|12.2|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo||
1690263|NCT01120184|3108177|Superiority or Other||Difference in Response Rate|-3.7|||||2-Sided|95.0|-11.4|3.9|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane||
1690264|NCT01120184|3108177|Superiority or Other||Difference in Response Rate|-8.2|||||2-Sided|95.0|-15.9|-0.5|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane||
1690265|NCT01120184|3108187|Superiority or Other||Hazard Ratio (HR)|0.78|||||2-Sided|97.5|0.65|0.95|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690266|NCT01120184|3108187|Superiority or Other||Hazard Ratio (HR)|0.8|||||2-Sided|97.5|0.66|0.97|||||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690267|NCT01120184|3108189|Superiority or Other||Hazard Ratio (HR)|0.77|||||2-Sided|97.5|0.63|0.95|||||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690268|NCT01120184|3108189|Superiority or Other||Hazard Ratio (HR)|0.85|||||2-Sided|97.5|0.69|1.04|||||Direction of comparison: Trastuzumab Emtasine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690269|NCT01120184|3108191|Superiority or Other||Hazard Ratio (HR)|0.86||||0.5691|2-Sided|97.5|0.67|1.11|||Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690270|NCT01120184|3108191|Superiority or Other||Hazard Ratio (HR)|0.93||||0.6568|2-Sided|97.5|0.73|1.2|||Log Rank||Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690271|NCT01120184|3108193|Non-Inferiority or Equivalence|The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Hazard Ratio (HR)|0.91||||0.3075|2-Sided|97.5|0.73|1.13||Test and p-value apply for superiority test. Primary endpoint did not meet superiority of PFS for trastuzumab emtansine + pertuzumab versus trastuzumab + taxane (two-sided significance level 2.5%); thus, tests and p-value are considered descriptive.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab Emtansine + Placebo|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690272|NCT01120184|3108193|Non-Inferiority or Equivalence|The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was <1.1765. Superiority was achieved if the upper bound of the 97.5% CI was <1.00.|Hazard Ratio (HR)|0.87||||0.1407|2-Sided|97.5|0.69|1.08||Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690273|NCT01120184|3108193|Non-Inferiority or Equivalence|The study was powered for superiority with target hazard ratio (HR) equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was less than (<) 1.1765. Superiority was achieved if the upper bound of the 97.5% CI was <1.00.|Hazard Ratio (HR)|0.91||||0.3125|2-Sided|97.5|0.73|1.13||Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.|Log Rank||Direction of comparison: Trastuzumab Emtansine + Placebo vs. Trastuzumab + Taxane|Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes [trastuzumab and/or lapatinib], yes [no trastuzumab and/or lapatinib]), and visceral disease (present, absent).|
1690274|NCT01120028|3108200|Other||Rate Ratio|0.76||||0.52|2-Sided|95.0|0.34|1.73|||Log Rank||||
1690275|NCT01120028|3108201|Other||Rate Ratio|1.0||||0.99|2-Sided|95.0|0.51|1.97|||Log Rank||||
1690276|NCT01120028|3108202|Other||Rate ratio|1.51||||0.008|2-Sided|95.0|1.11|2.06|||Log Rank||||
1690277|NCT01120028|3108203|Other||Rate Ratio|1.02||||0.88|2-Sided|95.0|0.8|1.29|||Regression, Cox||||
1690278|NCT01120028|3108204|Other||Rate Ratio|1.99||||0.23|2-Sided|95.0|0.64|6.18|||Log Rank||||
1690287|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|3.108|||||2-Sided|95.0|-103.08|109.29|||||Day 7, 12 Hours||
1690288|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-7.966|||||2-Sided|95.0|-111.73|95.8|||||Day 7, 12 Hours||
1690289|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|24.715|||||2-Sided|95.0|-79.16|128.59|||||Day 7, 12 Hours||
1690290|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-46.924|||||2-Sided|95.0|-150.69|56.85|||||Day 7, 12 Hours||
1690291|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-19.594|||||2-Sided|95.0|-123.36|84.18|||||Day 7, 12 Hours||
1690292|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-9.76|||||2-Sided|95.0|-81.01|61.49|||||Day 7, 10 Hours||
1690293|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|32.734|||||2-Sided|95.0|-36.89|102.36|||||Day 7, 10 Hours||
1690294|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|7.148|||||2-Sided|95.0|-62.55|76.85|||||Day 7, 10 Hours||
1690295|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-0.222|||||2-Sided|95.0|-77.28|61.98|||||Day 7, 10 Hours||
1690296|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-0.222|||||2-Sided|95.0|-69.85|69.4|||||Day 7, 10 Hours||
1690297|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-59.755|||||2-Sided|95.0|-157.82|38.31|||||Day 7, 6 Hours||
1690298|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-24.499|||||2-Sided|95.0|-121.74|72.74|||||Day 7, 6 Hours||
1690299|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|28.323|||||2-Sided|95.0|-69.0|125.65|||||Day 7, 6 Hours||
1690300|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-77.9|||||2-Sided|95.0|-175.15|19.35|||||Day 7, 6 Hours||
1690301|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-58.864|||||2-Sided|95.0|-156.11|38.38|||||Day 7, 6 Hours||
1690302|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|20.8|||||2-Sided|95.0|-13.09|54.69|||||Day 7, 4 Hours||
1690303|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-2.618|||||2-Sided|95.0|-36.22|30.99|||||Day 7, 4 Hours||
1690304|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|9.523|||||2-Sided|95.0|-24.11|43.16|||||Day 7, 4 Hours||
1690305|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-5.025|||||2-Sided|95.0|-38.63|28.58|||||Day 7, 4 Hours||
1690306|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-7.231|||||2-Sided|95.0|-40.84|26.38|||||Day 7, 4 Hours||
1690307|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-50.605|||||2-Sided|95.0|-202.31|101.1|||||Day 7, 2 Hours||
1690308|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-48.27|||||2-Sided|95.0|-198.7|102.16|||||Day 7, 2 Hours||
1690309|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-4.201|||||2-Sided|95.0|-154.75|146.35|||||Day 7, 2 Hours||
1690310|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-116.462|||||2-Sided|95.0|-266.9|33.98|||||Day 7, 2 Hours||
1690311|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-114.34|||||2-Sided|95.0|-264.78|36.1|||||Day 7, 2 Hours||
1690312|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-118.462|||||2-Sided|95.0|-263.93|27.01|||||Day 7, 1 Hour||
1690313|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-104.468|||||2-Sided|95.0|-248.72|39.78|||||Day 7, 1 Hour||
1690314|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-69.113|||||2-Sided|95.0|-213.48|75.25|||||Day 7, 1 Hour||
1690315|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-151.722|||||2-Sided|95.0|-295.98|-7.46|||||Day 7, 1 Hour||
1690316|NCT01119846|3108283|Superiority or Other||Mean Difference (Net)|-70.457|||||2-Sided|95.0|-214.72|73.8|||||Day 7, 1 Hour||
1690317|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-1.043|||||2-Sided|95.0|-2.81|0.73|||||Comparison of Day 14, 24 Hours||
1690318|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-0.168|||||2-Sided|95.0|-1.98|1.65|||||Comparison of Day 14, 24 Hours||
1690319|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|0.501|||||2-Sided|95.0|-1.28|2.28|||||Comparison of Day 14, 24 Hours||
1690320|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-0.225|||||2-Sided|95.0|-1.99|1.55|||||Comparison of Day 14, 24 Hours||
1690321|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-0.515|||||2-Sided|95.0|-2.29|1.26|||||Comparison of Day 14, 24 Hours||
1690322|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-0.516|||||2-Sided|95.0|-3.4|2.37|||||Comparison of Day 7, 12 Hours||
1690323|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-0.265|||||2-Sided|95.0|-3.14|2.62|||||Comparison of Day 7, 12 Hours||
1690324|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|1.0|||||2-Sided|95.0|-1.89|3.89|||||Comparison of Day 7, 12 Hours||
1690325|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-1.325|||||2-Sided|95.0|-4.21|1.56|||||Comparison of Day 7, 12 Hours||
1690326|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-1.3|||||2-Sided|95.0|-4.2|1.6|||||Comparison of Day 7, 12 Hours||
1690327|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-1.509|||||2-Sided|95.0|-4.05|1.03|||||Comparison of Day 7, 10 Hours||
1690328|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|1.063|||||2-Sided|95.0|-1.47|3.6|||||Comparison of Day 7, 10 Hours||
1690329|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|2.418|||||2-Sided|95.0|-0.13|4.96|||||Comparison of Day 7, 10 Hours||
1690330|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|0.452|||||2-Sided|95.0|-2.09|2.99|||||Comparison of Day 7, 10 Hours||
1690331|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|0.147|||||2-Sided|95.0|-2.41|2.7|||||Comparison of Day 7, 10 Hours||
1690332|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-2.708|||||2-Sided|95.0|-5.55|0.14|||||Comparison of Day 7, 6 Hours||
1690333|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|1.062|||||2-Sided|95.0|-1.78|3.91|||||Comparison of Day 7, 6 Hours||
1690334|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|2.706|||||2-Sided|95.0|-0.14|5.56|||||Comparison of Day 7, 6 Hours||
1690335|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|0.456|||||2-Sided|95.0|-2.39|3.3|||||Comparison of Day 7, 6 Hours||
1690614|NCT01118455|3108496|Superiority or Other|||||||0.494|||||||ANOVA||||
1690336|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-0.189|||||2-Sided|95.0|-3.05|2.67|||||Comparison of Day 7, 6 Hours||
1690337|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-1.011|||||2-Sided|95.0|-3.05|1.02|||||Comparison of Day 7, 4 Hours||
1690338|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|1.233|||||2-Sided|95.0|-0.8|3.26|||||Comparison of Day 7, 4 Hours||
1690339|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|1.512|||||2-Sided|95.0|-0.53|3.55|||||Comparison of Day 7, 4 Hours||
1690340|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|0.475|||||2-Sided|95.0|-1.56|2.51|||||Comparison of Day 7, 4 Hours||
1690341|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-0.017|||||2-Sided|95.0|-2.06|2.03|||||Comparison of Day 7, 4 Hours||
1690342|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-1.222|||||2-Sided|95.0|-3.69|1.24|||||Comparison of Day 7, 2 Hours||
1690343|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|0.884|||||2-Sided|95.0|-1.58|3.34|||||Comparison of Day 7, 2 Hours||
1690344|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|2.441|||||2-Sided|95.0|-0.03|4.91|||||Comparison of Day 7, 2 Hours||
1690345|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-0.313|||||2-Sided|95.0|-2.78|2.15|||||Comparison of Day 7, 2 Hours||
1690346|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-0.795|||||2-Sided|95.0|-3.27|1.68|||||Comparison of Day 7, 2 Hours||
1690347|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-1.484|||||2-Sided|95.0|-3.99|1.02|||||Comparison of Day 7, 1 Hour||
1690348|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|0.316|||||2-Sided|95.0|-2.19|2.82|||||Comparison of Day 7, 1 Hour||
1690349|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|2.064|||||2-Sided|95.0|-0.45|4.57|||||Comparison of Day 7, 1 Hour||
1690350|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-0.569|||||2-Sided|95.0|-3.07|1.94|||||Comparison of Day 7, 1 Hour||
1690351|NCT01119846|3108284|Superiority or Other||Mean Difference (Net)|-0.523|||||2-Sided|95.0|-3.04|2.0|||||Comparison of Day 7, 1 Hour||
1690352|NCT01119846|3108285|Superiority or Other||Mean Difference (Final Values)|0.133|||||2-Sided|95.0|-1.43|1.7|||||||
1690353|NCT01119846|3108285|Superiority or Other||Mean Difference (Final Values)|-0.388|||||2-Sided|95.0|-2.16|1.38|||||||
1690354|NCT01119846|3108285|Superiority or Other||Mean Difference (Final Values)|-0.045|||||2-Sided|95.0|-1.82|1.73|||||||
1690355|NCT01119846|3108285|Superiority or Other||Mean Difference (Final Values)|-0.346|||||2-Sided|95.0|-2.06|1.37|||||||
1690356|NCT01119846|3108286|Superiority or Other||Mean Difference (Final Values)|-0.041|||||2-Sided|95.0|-0.27|0.19|||||Comparison of insulin glucose index||
1690357|NCT01119846|3108286|Superiority or Other||Mean Difference (Final Values)|-0.028|||||2-Sided|95.0|-0.29|0.23|||||Comparison of insulin glucose index||
1690358|NCT01119846|3108286|Superiority or Other||Mean Difference (Final Values)|0.055|||||2-Sided|95.0|-0.2|0.31|||||Comparison of insulin glucose index||
1690359|NCT01119846|3108286|Superiority or Other||Mean Difference (Final Values)|-0.025|||||2-Sided|95.0|-0.28|0.22|||||Comparison of insulin glucose index||
1690360|NCT01119846|3108287|Superiority or Other||Mean Difference (Final Values)|4.017|||||2-Sided|95.0|-5.65|13.68|||||Comparison of I/G ratio||
1690361|NCT01119846|3108287|Superiority or Other||Mean Difference (Final Values)|6.053|||||2-Sided|95.0|-4.88|16.99|||||Comparison of I/G ratio||
1690362|NCT01119846|3108287|Superiority or Other||Mean Difference (Final Values)|2.959|||||2-Sided|95.0|-8.01|13.93|||||Comparison of I/G ratio||
1690363|NCT01119846|3108287|Superiority or Other||Mean Difference (Final Values)|2.269|||||2-Sided|95.0|-8.31|12.85|||||Comparison of I/G ratio||
1690364|NCT01119846|3108287|Superiority or Other||Mean Difference (Final Values)|0.017|||||2-Sided|95.0|-0.04|0.08|||||Comparison of G/I ratio||
1690365|NCT01119846|3108287|Superiority or Other||Mean Difference (Final Values)|-0.003|||||2-Sided|95.0|-0.07|0.07|||||Comparison of G/I ratio||
1690366|NCT01119846|3108287|Superiority or Other||Mean Difference (Final Values)|-0.002|||||2-Sided|95.0|-0.07|0.07|||||Comparison of G/I ratio||
1690367|NCT01119846|3108287|Superiority or Other||Mean Difference (Final Values)|-0.01|||||2-Sided|95.0|-0.08|0.06|||||Comparison of G/I ratio||
1690368|NCT01119846|3108288|Superiority or Other||Mean Difference (Final Values)|0.172|||||2-Sided|95.0|-0.81|1.16|||||||
1690369|NCT01119846|3108288|Superiority or Other||Mean Difference (Final Values)|-0.053|||||2-Sided|95.0|-1.17|1.06|||||||
1690370|NCT01119846|3108288|Superiority or Other||Mean Difference (Final Values)|0.523|||||2-Sided|95.0|-0.6|1.64|||||||
1690371|NCT01119846|3108288|Superiority or Other||Mean Difference (Final Values)|0.241|||||2-Sided|95.0|-0.84|1.32|||||||
1690372|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|-3.506|||||2-Sided|95.0|-7.75|0.74|||||Comparison of PYY total, iAUC 0-2||
1690373|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|1.726|||||2-Sided|95.0|-3.08|6.53|||||Comparison of PYY total, iAUC 0-2||
1690374|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|5.296|||||2-Sided|95.0|0.47|10.12|||||Comparison of PYY total, iAUC 0-2||
1690375|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|2.523|||||2-Sided|95.0|-2.13|7.17|||||Comparison of PYY total, iAUC 0-2||
1690376|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|-2.555|||||2-Sided|95.0|-8.62|3.51|||||Comparison of PYY total, AUC 0-2||
1690377|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|7.006|||||2-Sided|95.0|0.15|13.87|||||Comparison of PYY total, AUC 0-2||
1690378|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|7.295|||||2-Sided|95.0|0.41|14.18|||||Comparison of PYY total, AUC 0-2||
1690379|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|3.506|||||2-Sided|95.0|-3.13|10.14|||||Comparison of PYY total, AUC 0-2||
1690380|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|23.606|||||2-Sided|95.0|-57.59|104.8|||||Comparison of Insulin, iAUC 0-3||
1690381|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|20.053|||||2-Sided|95.0|-71.8|111.91|||||Comparison of Insulin, iAUC 0-3||
1690382|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|-0.316|||||2-Sided|95.0|-92.47|91.84|||||Comparison of Insulin, iAUC 0-3||
1690383|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|2.088|||||2-Sided|95.0|-86.79|90.97|||||Comparison of Insulin, iAUC 0-3||
1690384|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|22.994|||||2-Sided|95.0|-76.77|122.76|||||Comparison of Insulin, AUC 0-3||
1690385|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|32.426|||||2-Sided|95.0|-80.43|145.28|||||Comparison of Insulin, AUC 0-3||
1690386|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|9.98|||||2-Sided|95.0|-103.25|123.21|||||Comparison of Insulin, AUC 0-3||
1690387|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|13.389|||||2-Sided|95.0|-95.82|122.59|||||Comparison of Insulin, AUC 0-3||
1690388|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|-1.249|||||2-Sided|95.0|-3.72|1.22|||||Comparison of Glucagon, iAUC 0-2||
1690389|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|-1.053|||||2-Sided|95.0|-3.74|1.63|||||Comparison of Glucagon, iAUC 0-2||
1690390|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|-1.909|||||2-Sided|95.0|-4.74|0.93|||||Comparison of Glucagon, iAUC 0-2||
1690391|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|-2.177|||||2-Sided|95.0|-4.92|0.56|||||Comparison of Glucagon, iAUC 0-2||
1690392|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|0.274|||||2-Sided|95.0|-2.2|2.74|||||Comparison of Glucagon, AUC 0-2||
1690393|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|1.473|||||2-Sided|95.0|-1.21|4.16|||||Comparison of Glucagon, AUC 0-2||
1690394|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|2.877|||||2-Sided|95.0|0.04|5.71|||||Comparison of Glucagon, AUC 0-2||
1690395|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|1.235|||||2-Sided|95.0|-1.51|3.98|||||Comparison of Glucagon, AUC 0-2||
1690396|NCT01119846|3108289|Superiority or Other||Median Difference (Final Values)|-1.19|||||2-Sided|95.0|-2.34|-0.04|||||Comparison of GLP-1 total, iAUC 0-2||
1690397|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|-0.177|||||2-Sided|95.0|-1.48|1.12|||||Comparison of GLP-1 total, iAUC 0-2||
1690398|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|0.331|||||2-Sided|95.0|-0.97|1.63|||||Comparison of GLP-1 total, iAUC 0-2||
1690399|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|0.081|||||2-Sided|95.0|-1.18|1.34|||||Comparison of GLP-1 total, iAUC 0-2||
1690400|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|-1.483|||||2-Sided|95.0|-2.85|-0.12|||||Comparison of GLP-1 total, AUC 0-2||
1690401|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|0.894|||||2-Sided|95.0|-0.65|2.44|||||Comparison of GLP-1 total, AUC 0-2||
1690402|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|0.268|||||2-Sided|95.0|-1.28|1.82|||||Comparison of GLP-1 total, AUC 0-2||
1690403|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|0.055|||||2-Sided|95.0|-1.44|1.55|||||Comparison of GLP-1 total, AUC 0-2||
1690404|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|2.643|||||2-Sided|95.0|2.25|3.04|||||Comparison of GLP-1 active, iAUC 0-2||
1690405|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|0.031|||||2-Sided|95.0|-0.41|0.47|||||Comparison of GLP-1 active, iAUC 0-2||
1690406|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|0.243|||||2-Sided|95.0|-0.2|0.69|||||Comparison of GLP-1 active, iAUC 0-2||
1690407|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|0.071|||||2-Sided|95.0|-0.36|0.5|||||Comparison of GLP-1 active, iAUC 0-2||
1690408|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|2.694|||||2-Sided|95.0|2.28|3.11|||||Comparison of GLP-1 active, AUC 0-2||
1690409|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|0.048|||||2-Sided|95.0|-0.42|0.51|||||Comparison of GLP-1 active, AUC 0-2||
1690410|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|0.256|||||2-Sided|95.0|-0.21|0.72|||||Comparison of GLP-1 active, AUC 0-2||
1690411|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|0.066|||||2-Sided|95.0|-0.38|0.52|||||Comparison of GLP-1 active, AUC 0-2||
1690412|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|-2.786|||||2-Sided|95.0|-11.65|6.08|||||Comparison of GIP total, iAUC 0-2||
1690413|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|9.484|||||2-Sided|95.0|-0.54|19.51|||||Comparison of GIP total, iAUC 0-2||
1690414|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|4.598|||||2-Sided|95.0|-5.46|14.65|||||Comparison of GIP total, iAUC 0-2||
1690415|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|6.227|||||2-Sided|95.0|-3.47|15.93|||||Comparison of GIP total, iAUC 0-2||
1690416|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|-2.824|||||2-Sided|95.0|-13.17|7.52|||||Comparison of GIP total, AUC 0-2||
1690417|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|13.033|||||2-Sided|95.0|1.33|24.74|||||Comparison of GIP total, AUC 0-2||
1690418|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|4.095|||||2-Sided|95.0|-7.65|15.84|||||Comparison of GIP total, AUC 0-2||
1690419|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|6.539|||||2-Sided|95.0|-4.79|17.87|||||Comparison of GIP total, AUC 0-2||
1690420|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|157.044|||||2-Sided|95.0|-108.73|422.82|||||Comparison of C-peptide, iAUC 0-2||
1690421|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|78.341|||||2-Sided|95.0|-222.32|379.0|||||Comparison of C-peptide, iAUC 0-2||
1690422|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|58.074|||||2-Sided|95.0|-243.57|359.72|||||Comparison of C-peptide, iAUC 0-2||
1690423|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|163.622|||||2-Sided|95.0|-127.31|454.55|||||Comparison of C-peptide, iAUC 0-2||
1690424|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|136.638|||||2-Sided|95.0|-186.32|459.6|||||Comparison of C-peptide, AUC 0-2||
1690425|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|114.474|||||2-Sided|95.0|-250.89|479.83|||||Comparison of C-peptide, AUC 0-2||
1690426|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|113.866|||||2-Sided|95.0|-252.69|480.42|||||Comparison of C-peptide, AUC 0-2||
1690427|NCT01119846|3108289|Superiority or Other||Mean Difference (Final Values)|152.962|||||2-Sided|95.0|-200.57|506.49|||||Comparison of C-peptide, AUC 0-2||
1690428|NCT01119846|3108290|Superiority or Other||Mean Difference (Final Values)|-0.99|||||2-Sided|95.0|-1.91|-0.07|||||Comparison of iAUC 0-3||
1690429|NCT01119846|3108290|Superiority or Other||Mean Difference (Final Values)|-1.103|||||2-Sided|95.0|-2.15|-0.06|||||Comparison of iAUC 0-3||
1690430|NCT01119846|3108290|Superiority or Other||Mean Difference (Final Values)|-0.956|||||2-Sided|95.0|-2.01|0.09|||||Comparison of iAUC 0-3||
1690431|NCT01119846|3108290|Superiority or Other||Mean Difference (Final Values)|-0.626|||||2-Sided|95.0|-1.64|0.39|||||Comparison of iAUC 0-3||
1690432|NCT01119846|3108290|Superiority or Other||Mean Difference (Final Values)|-0.617|||||2-Sided|95.0|-2.56|1.33|||||Comparison of AUC 0-3||
1690433|NCT01119846|3108290|Superiority or Other||Mean Difference (Final Values)|-1.175|||||2-Sided|95.0|-3.37|1.02|||||Comparison of AUC 0-3||
1690434|NCT01119846|3108290|Superiority or Other||Mean Difference (Final Values)|-0.846|||||2-Sided|95.0|-3.05|1.36|||||Comparison of AUC 0-3||
1690435|NCT01119846|3108290|Superiority or Other||Mean Difference (Final Values)|-0.564|||||2-Sided|95.0|-2.69|1.56|||||Comparison of AUC 0-3||
1690436|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-6.39|||||2-Sided|95.0|-12.67|-0.11|||||Comparison of PYY total, iAUC 0-12||
1690437|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|9.036|||||2-Sided|95.0|1.93|16.14|||||Comparison of PYY total, iAUC 0-12||
1690438|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|6.909|||||2-Sided|95.0|-0.22|14.03|||||Comparison of PYY total, iAUC 0-12||
1690439|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|4.999|||||2-Sided|95.0|-1.87|11.87|||||Comparison of PYY total, iAUC 0-12||
1690440|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-5.44|||||2-Sided|95.0|-13.33|2.45|||||Comparison of PYY total, AUC 0-12||
1690441|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|14.317|||||2-Sided|95.0|5.39|23.24|||||Comparison of PYY total, AUC 0-12||
1690442|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|8.908|||||2-Sided|95.0|-0.05|17.86|||||Comparison of PYY total, AUC 0-12||
1690443|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|5.982|||||2-Sided|95.0|-2.66|14.62|||||Comparison of PYY total, AUC 0-12||
1690444|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-66.324|||||2-Sided|95.0|-170.95|38.3|||||Comparison of Insulin, iAUC 0-13||
1690445|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-22.0|||||2-Sided|95.0|-140.36|96.36|||||Comparison of Insulin, iAUC 0-13||
1690446|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-22.525|||||2-Sided|95.0|-141.27|96.22|||||Comparison of Insulin, iAUC 0-13||
1690447|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-36.042|||||2-Sided|95.0|-150.57|78.48|||||Comparison of Insulin, iAUC 0-13||
1690448|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-66.936|||||2-Sided|95.0|-198.15|64.28|||||Comparison of Insulin, AUC 0-13||
1690449|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-9.628|||||2-Sided|95.0|-158.07|138.81|||||Comparison of Insulin, AUC 0-13||
1690450|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-12.229|||||2-Sided|95.0|-161.16|136.7|||||Comparison of Insulin, AUC 0-13||
1690451|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-24.74|||||2-Sided|95.0|-168.38|118.9|||||Comparison of Insulin, AUC 0-13||
1690452|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-1.573|||||2-Sided|95.0|-4.86|1.71|||||Comparison of Glucagon, iAUC 0-12||
1690453|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-0.436|||||2-Sided|95.0|-4.16|3.29|||||Comparison of Glucagon, iAUC 0-12||
1690454|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-0.865|||||2-Sided|95.0|-4.68|2.95|||||Comparison of Glucagon, iAUC 0-12||
1690455|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-2.866|||||2-Sided|95.0|-6.4|0.67|||||Comparison of Glucagon, iAUC 0-12||
1690456|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-0.714|||||2-Sided|95.0|-5.56|4.13|||||Comparison of Glucagon, AUC 0-12||
1690457|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|2.517|||||2-Sided|95.0|-2.98|8.01|||||Comparison of Glucagon, AUC 0-12||
1690458|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|3.067|||||2-Sided|95.0|-2.56|8.69|||||Comparison of Glucagon, AUC 0-12||
1690459|NCT01119846|3108291|Superiority||Mean Difference (Final Values)|0.962|||||2-Sided|95.0|-4.26|6.18|||||Comparison of Glucagon, AUC 0-12||
1690460|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-1.336|||||2-Sided|95.0|-2.96|0.29|||||Comparison of GLP-1 total, iAUC 0-12||
1690461|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|0.764|||||2-Sided|95.0|-1.08|2.6|||||Comparison of GLP-1 total, iAUC 0-12||
1690462|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|0.286|||||2-Sided|95.0|-1.56|2.13|||||Comparison of GLP-1 total, iAUC 0-12||
1690463|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|0.078|||||2-Sided|95.0|-1.7|1.86|||||Comparison of GLP-1 total, iAUC 0-12||
1690464|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-1.629|||||2-Sided|95.0|-3.56|0.3|||||Comparison of GLP-1 total, AUC 0-12||
1690465|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|1.835|||||2-Sided|95.0|-0.35|4.02|||||Comparison of GLP-1 total, AUC 0-12||
1690466|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|0.223|||||2-Sided|95.0|-1.97|2.42|||||Comparison of GLP-1 total, AUC 0-12||
1690467|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|0.052|||||2-Sided|95.0|-2.06|2.17|||||Comparison of GLP-1 total, AUC 0-12||
1690468|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|3.399|||||2-Sided|95.0|2.69|4.11|||||Comparison of GLP-1 active, iAUC 0-12||
1690469|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|0.018|||||2-Sided|95.0|-0.79|0.83|||||Comparison of GLP-1 active, iAUC 0-12||
1690470|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|0.006|||||2-Sided|95.0|-0.79|0.8|||||Comparison of GLP-1 active, iAUC 0-12||
1690471|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-0.015|||||2-Sided|95.0|-0.78|0.75|||||Comparison of GLP-1 active, iAUC 0-12||
1690472|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|3.454|||||2-Sided|95.0|2.74|4.17|||||Comparison of GLP-1 active, AUC 0-12||
1690473|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|0.039|||||2-Sided|95.0|-0.78|0.85|||||Comparison of GLP-1 active, AUC 0-12||
1690474|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|0.022|||||2-Sided|95.0|-0.78|0.82|||||Comparison of GLP-1 active, AUC 0-12||
1690475|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-0.018|||||2-Sided|95.0|-0.79|0.76|||||Comparison of GLP-1 active, AUC 0-12||
1690476|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-7.055|||||2-Sided|95.0|-15.99|1.88|||||Comparison of GIP total, iAUC 0-12||
1690477|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|7.934|||||2-Sided|95.0|-2.17|18.04|||||Comparison of GIP total, iAUC 0-12||
1690478|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|3.526|||||2-Sided|95.0|-6.61|13.67|||||Comparison of GIP total, iAUC 0-12||
1690479|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|2.5|||||2-Sided|95.0|-7.28|12.28|||||Comparison of GIP total, iAUC 0-12||
1690480|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-7.093|||||2-Sided|95.0|-17.04|2.86|||||Comparison of GIP total, AUC 0-12||
1690481|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|11.483|||||2-Sided|95.0|0.23|22.74|||||Comparison of GIP total, AUC 0-12||
1690482|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|3.023|||||2-Sided|95.0|-8.27|14.32|||||Comparison of GIP total, AUC 0-12||
1690483|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|2.812|||||2-Sided|95.0|-8.08|13.7|||||Comparison of GIP total, AUC 0-12||
1690484|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-81.016|||||2-Sided|95.0|-356.07|194.03|||||Comparison of C-peptide, iAUC 0-12||
1690485|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-121.982|||||2-Sided|95.0|-433.14|189.18|||||Comparison of C-peptide, iAUC 0-12||
1690486|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-117.435|||||2-Sided|95.0|-429.61|194.74|||||Comparison of C-peptide, iAUC 0-12||
1690487|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-39.239|||||2-Sided|95.0|-340.32|261.85|||||Comparison of C-peptide, iAUC 0-12||
1690488|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-101.422|||||2-Sided|95.0|-494.09|291.25|||||Comparison of C-peptide, AUC 0-12||
1690489|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-85.849|||||2-Sided|95.0|-530.07|358.37|||||Comparison of C-peptide, AUC 0-12||
1690490|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-61.642|||||2-Sided|95.0|-507.32|384.04|||||Comparison of C-peptide, AUC 0-12||
1690491|NCT01119846|3108291|Superiority or Other||Mean Difference (Final Values)|-49.898|||||2-Sided|95.0|-479.74|379.94|||||Comparison of C-peptide, AUC 0-12||
1690492|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|-0.661|||||2-Sided|95.0|-1.72|0.4|||||Comparison of iAUC(0-24)||
1690493|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|-0.247|||||2-Sided|95.0|-1.44|0.95|||||Comparison of iAUC(0-24)||
1690494|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|-0.017|||||2-Sided|95.0|-1.24|1.21|||||Comparison of iAUC(0-24)||
1690495|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|-0.499|||||2-Sided|95.0|-1.68|0.68|||||Comparison of iAUC(0-24)||
1690496|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|-0.206|||||2-Sided|95.0|-1.33|0.91|||||Comparison of iAUC(0-13)||
1690497|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|-0.091|||||2-Sided|95.0|-1.36|1.18|||||Comparison of iAUC(0-13)||
1690498|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|-0.136|||||2-Sided|95.0|-1.41|1.13|||||Comparison of iAUC(0-13)||
1690499|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|-0.352|||||2-Sided|95.0|-1.58|0.87|||||Comparison of iAUC(0-13)||
1690500|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|0.167|||||2-Sided|95.0|-1.88|2.21|||||Comparison of AUC(0-13)||
1690501|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|-0.163|||||2-Sided|95.0|-2.48|2.15|||||Comparison of AUC(0-13)||
1690502|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|-0.026|||||2-Sided|95.0|-2.35|2.3|||||Comparison of AUC(0-13)||
1690503|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|-0.29|||||2-Sided|95.0|-2.53|1.95|||||Comparison of AUC(0-13)||
1690504|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|0.469|||||2-Sided|95.0|-1.39|2.33|||||Comparison of AUC(0-24)||
1690505|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|0.451|||||2-Sided|95.0|-1.64|2.54|||||Comparison of AUC(0-24)||
1690506|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|0.614|||||2-Sided|95.0|-1.53|2.76|||||Comparison of AUC(0-24)||
1690507|NCT01119846|3108292|Superiority or Other||Mean Difference (Final Values)|0.265|||||2-Sided|95.0|-1.8|2.33|||||Comparison of AUC(0-24)||
1690508|NCT01119846|3108293|Superiority or Other||Mean Difference (Net)|-0.679|||||2-Sided|95.0|-1.8|0.45|||||||
1690509|NCT01119846|3108293|Superiority or Other||Mean Difference (Net)|0.046|||||2-Sided|95.0|-1.1|1.19|||||||
1690510|NCT01119846|3108293|Superiority or Other||Mean Difference (Net)|0.225|||||2-Sided|95.0|-0.9|1.35|||||||
1690511|NCT01119846|3108293|Superiority or Other||Mean Difference (Net)|-0.036|||||2-Sided|95.0|-1.17|1.1|||||||
1690512|NCT01119846|3108308|Superiority or Other||Slope|0.5808|||||2-Sided|90.0|0.5325|0.6291|||||Dose Proportionality for GSK1292263 Using the Power Model for AUC0-last.||
1690513|NCT01119846|3108308|Superiority or Other||Slope|0.5828|||||2-Sided|90.0|0.5282|0.6375|||||Dose Proportionality for GSK1292263 Using the Power Model for AUC0-24.||
1690514|NCT01119846|3108310|Superiority or Other||Slope|0.5782|||||2-Sided|90.0|0.523|0.6335|||||Dose Proportionality for GSK1292263 Using the Power Model.||
1690515|NCT01119703|3108340|Superiority or Other||Coefficient of Determination %|-2.2|||||2-Sided|95.0|-7.8|4.4|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) <= 20%; whereas the alternative hypothesis is > 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.|
1690516|NCT01119703|3108341|Superiority or Other||Coefficient of Determination %|36.7|||||2-Sided|95.0|28.7|41.5|||||Crossvalidated;negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) <= 20%; whereas the alternative hypothesis is > 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.|
1690517|NCT01119703|3108342|Superiority or Other||Coefficient of Determination %|23.7|||||2-Sided|95.0|14.0|29.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) <= 20%; whereas the alternative hypothesis is > 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.|
1690518|NCT01119703|3108343|Superiority or Other||Coefficient of Determination %|-9.5|||||2-Sided|95.0|-16.6|-2.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) <= 20%; whereas the alternative hypothesis is > 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all Day 7 biomarkers as predictors.|
1690519|NCT01119703|3108344|Superiority or Other||Spearman's Correlation Coefficient|0.08||||0.36|2-Sided|95.0|-0.09|0.24|||Fisher's Z-transformation||Within-participant rank correlation|Cholera versus Tetanus|
1690520|NCT01119703|3108344|Superiority or Other||Spearman's Correlation Coefficient|-0.09||||0.3|2-Sided|95.0|-0.25|0.08|||Fisher's Z-transformation||Within-participant rank correlation|Hepatitis B versus Tetanus|
1690521|NCT01119703|3108344|Superiority or Other||Spearman's Correlation Coefficient|-0.17||||0.04|2-Sided|95.0|-0.32|-0.01|||Fisher's Z-transformation||Within-participant rank correlation|Hepatitis B versus Cholera|
1690522|NCT01119703|3108344|Superiority or Other||Spearman's Correlation Coefficient|0.4|||<|0.001|2-Sided|95.0|0.26|0.53|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Tetanus|
1690523|NCT01119703|3108344|Superiority or Other||Spearman's Correlation Coefficient|0.1|||<|0.26|2-Sided|95.0|-0.07|0.25|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Cholera|
1690524|NCT01119703|3108344|Superiority or Other||Spearman's Correlation Coefficient|-0.04|||<|0.66|2-Sided|95.0|-0.2|0.13|||Fisher's Z-transformation||Within-participant rank correlation|Diphtheria versus Hepatitis B|
1690525|NCT01119703|3108345|Superiority or Other||Coefficient of Determination %|3.3||||||95.0|-2.8|8.5|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) <= 20%; whereas the alternative hypothesis is > 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.|
1690526|NCT01119703|3108346|Superiority or Other||Coefficient of Determination %|27.8|||||2-Sided|95.0|19.6|32.4|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) <= 20%; whereas the alternative hypothesis is > 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.|
1690527|NCT01119703|3108347|Superiority or Other||Coefficient of Determination %|17.6|||||2-Sided|95.0|10.6|20.9|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) <= 20%; whereas the alternative hypothesis is > 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.|
1690528|NCT01119703|3108348|Superiority or Other||Coefficient of Determination %|-9.1|||||2-Sided|95.0|-13.8|-0.7|||||Crossvalidated; negative values mean that the fitted model performs worse than chance on the test set.|Null hypothesis for Predicted versus Measured Titers states that Coefficient of Determination % (CD%) <= 20%; whereas the alternative hypothesis is > 20%. CD% was obtained by fitting a random forest model to the measured titers, which included all baseline biomarkers as predictors.|
1690529|NCT01119443|3108377|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|92.63|||||2-Sided|90.0|77.871|110.185|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690530|NCT01119443|3108379|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|109.48|||||2-Sided|90.0|89.571|133.811|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690531|NCT01119443|3108380|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|99.069|||||2-Sided|90.0|80.688|117.45|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690532|NCT01119443|3108381|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|86.57|||||2-Sided|90.0|73.583|101.854|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690533|NCT01119443|3108382|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|86.57|||||2-Sided|90.0|73.583|101.854|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690534|NCT01119443|3108383|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|100.2|||||2-Sided|90.0|94.0|106.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690535|NCT01119443|3108384|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition|Test/Reference Ratio of the mean x 100|93.6||||||90.0|86.9|100.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690536|NCT01119443|3108385|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.07|||||2-Sided|90.0|91.585|118.263|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690537|NCT01119443|3108387|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|95.11|||||2-Sided|90.0|82.461|109.698|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690538|NCT01119443|3108388|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|98.426|||||2-Sided|90.0|84.276|112.58|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690539|NCT01119443|3108389|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|106.85|||||2-Sided|90.0|93.189|122.251|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690540|NCT01119443|3108390|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|108.31|||||2-Sided|90.0|95.634|122.676|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690541|NCT01119443|3108391|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.8||||||90.0|100.1|109.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690542|NCT01119443|3108392|Non-Inferiority or Equivalence|Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition|Test/Reference Ratio of the mean x 100|104.2|||||2-Sided|90.0|98.3|110.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1690543|NCT01119248|3108395|Superiority or Other|||||||0.001|||||||t-test, 2 sided||||
1690544|NCT01119248|3108396|Superiority or Other||Mean Difference (Final Values)|-0.69||||0.0001|2-Sided|95.0|-0.95|-0.43|||t-test, 2 sided|||pre- MRI body temperature was associated with change in body temperature after MRI by bivariate analysis. The values presented are adjusted for body surface area, type of MRI, room temperature and duration of MRI|
1690545|NCT01119248|3108397|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Deviation|0.62|<|0.001|2-Sided|95.0|-0.48|-0.25|||t-test, 2 sided||||
1690546|NCT01119222|3108404|Superiority or Other||Mean Difference (Final Values)|0.84|Standard Error of the Mean|2.17|||2-Sided|90.0|-2.8|4.48|||||||
1690547|NCT01119222|3108404|Superiority or Other||Mean Difference (Final Values)|-9.43|Standard Error of the Mean|2.17|||2-Sided|90.0|-13.07|-5.79|||||||
1690548|NCT01119222|3108404|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|2.17|||2-Sided|90.0|-4.24|3.04|||||||
1690549|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|2.22|||2-Sided|90.0|-3.99|3.45||||||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690550|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|-7.47|Standard Error of the Mean|2.22|||2-Sided|90.0|-11.19|-3.75||||||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690551|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|0.49|Standard Error of the Mean|2.22|||2-Sided|90.0|-3.23|4.22||||||8 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690552|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|2.9|||2-Sided|90.0|-4.85|4.85||||||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690553|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|-9.59|Standard Error of the Mean|2.9|||2-Sided|90.0|-14.44|-4.73||||||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690554|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|-2.53|Standard Error of the Mean|2.9|||2-Sided|90.0|-7.39|2.32||||||4 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690555|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|1.58|Standard Error of the Mean|3.59|||2-Sided|90.0|-4.45|7.6||||||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690556|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|-13.12|Standard Error of the Mean|3.59|||2-Sided|90.0|-19.14|-7.09||||||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690557|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|0.82|Standard Error of the Mean|3.66|||2-Sided|90.0|-5.32|6.96||||||2 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690558|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|2.88|Standard Error of the Mean|2.92|||2-Sided|90.0|-2.01|7.78||||||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690559|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|-13.93|Standard Error of the Mean|2.87|||2-Sided|90.0|-18.74|-9.13||||||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690615|NCT01118455|3108496|Superiority or Other|||||||0.691|||||||ANOVA||||
1690560|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|-0.73|Standard Error of the Mean|2.87|||2-Sided|90.0|-5.53|4.08||||||1.5 hours post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690561|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|5.49|Standard Error of the Mean|1.96|||2-Sided|90.0|2.2|8.78||||||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690562|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|-11.18|Standard Error of the Mean|1.97|||2-Sided|90.0|-14.48|-7.89||||||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690563|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|2.14|Standard Error of the Mean|1.97|||2-Sided|90.0|-1.15|5.44||||||1 hour post-dose: mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690564|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|2.45|||2-Sided|90.0|-3.99|4.22||||||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690565|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|0.58|Standard Error of the Mean|2.45|||2-Sided|90.0|-3.53|4.68||||||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual.|
1690566|NCT01119222|3108405|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Error of the Mean|2.45|||2-Sided|90.0|-3.82|4.38||||||Pre-dose; mixed effect model with random subject effect, fixed period and treatment effects and random subject-by-visit effect as residual. Sample sizing calculated based on results from previous methodology studies performed using the same cold pain test; primary criteria was ability to detect a significant gabapentin effect over placebo.|
1690567|NCT01119131|3108406|Superiority or Other|||||||0.957|||||||ANOVA||||
1690568|NCT01119131|3108407|Superiority or Other|||||||0.949|||||||ANOVA||||
1690569|NCT01119131|3108409|Superiority or Other|||||||0.793|||||||ANOVA||||
1690570|NCT01119131|3108410|Superiority or Other|||||||0.253|||||||ANOVA||||
1690571|NCT01119131|3108411|Superiority or Other|||||||0.419|||||||ANOVA||||
1690572|NCT01119131|3108412|Superiority or Other|||||||0.308|||||||ANOVA||||
1690573|NCT01119131|3108413|Superiority or Other|||||||0.699|||||||ANOVA||||
1690574|NCT01118780|3108460|Superiority or Other||||||<|0.001||||||The p-value was adjusted for pooled investigator.|Log Rank||||
1690575|NCT01118780|3108461|Superiority or Other|||||||0.003||||||The p-value is for time to first functional remission (SDS Global Functional Impairment Score ≤6) and was adjusted for pooled investigator.|Log Rank||||
1690576|NCT01118780|3108461|Superiority or Other|||||||0.006||||||The p-value is for the time to first functional remission (SDS Global Functional Impairment Score ≤5) and was adjusted for pooled investigator.|Log Rank||||
1690577|NCT01118780|3108462|Superiority or Other|||||||0.001||||||The p-value was adjusted for pooled investigator.|Log Rank||||
1690578|NCT01118780|3108463|Superiority or Other||||||<|0.001||||||The p-value is for the time to first remission (HAMA Total Score ≤10) and was adjusted for pooled investigator.|Log Rank||||
1690579|NCT01118780|3108464|Superiority or Other|||||||0.005||||||The p-value was adjusted for pooled investigator.|Log Rank||||
1690580|NCT01118780|3108468|Superiority or Other|||||||0.038||||||The p-value is for the percentage of participants having HAMA sustained improvement from Week 2 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel||||
1690581|NCT01118780|3108468|Superiority or Other|||||||0.001||||||The p-value is for the percentage of participants having HAMA sustained improvement overall and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel||||
1690582|NCT01118780|3108469|Superiority or Other||||||<|0.001||||||The p-value is for the percentage of participants having functional remission (SDS Global Score ≤6) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel||||
1690583|NCT01118780|3108469|Superiority or Other||||||<|0.001||||||The p-value is for the percentage of participants having functional remission (SDS Global Score ≤5) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel||||
1690584|NCT01118780|3108470|Superiority or Other||||||<|0.001||||||The p-value is for percentage of participants having remission (HAMA Total Score ≤10) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel||||
1690585|NCT01118780|3108470|Superiority or Other||||||<|0.001||||||The p-value is for percentage of participants having remission (HAMA Total Score ≤7) at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel||||
1690586|NCT01118780|3108470|Superiority or Other||||||<|0.001||||||The p-value is for percentage of participants having HAMA response at Week 10 and was adjusted for pooled investigator.|Cochran-Mantel-Haenszel||||
1690587|NCT01118780|3108471|Superiority or Other||LS mean difference|1.21|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|0.61|1.81||The p-value is for the change from baseline to Week 10 in SDS for Family/Home Management Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690588|NCT01118780|3108471|Superiority or Other||LS mean difference|0.9|Standard Error of the Mean|0.29|<|0.002|2-Sided|95.0|0.32|1.48||The p-value is for the change from baseline to Week 10 in SDS for Social Life/Leisure Activities Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690589|NCT01118780|3108471|Superiority or Other||LS mean difference|1.13|Standard Error of the Mean|0.43|<|0.01|2-Sided|95.0|0.27|1.98||The p-value is for the change from baseline to Week 10 in SDS for Work/School Impairment Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690590|NCT01118780|3108473|Superiority or Other||LS mean difference|-5.76|Standard Error of the Mean|1.87||0.002|2-Sided|95.0|-9.4|-2.1|||ANCOVA||LS mean difference was calculated by placebo minus duloxetine. Negative values indicated improvement over placebo.||
1690616|NCT01118455|3108497|Superiority or Other|||||||0.654|||||||t-test, 2 sided||||
1690591|NCT01118780|3108474|Superiority or Other||LS mean difference|0.5|Standard Error of the Mean|0.29||0.088|2-Sided|95.0|-0.07|1.07||The p-value is for the change from baseline to Week 10 in BPI-SF Enjoyment of Life Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690592|NCT01118780|3108474|Superiority or Other||LS mean difference|0.5|Standard Error of the Mean|0.34||0.141|2-Sided|95.0|-0.17|1.18||The p-value is for the change from baseline to Week 10 in BPI-SF Sleep Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690593|NCT01118780|3108474|Superiority or Other||LS mean difference|0.17|Standard Error of the Mean|0.26||0.515|2-Sided|95.0|-0.34|0.68||The p-value is for the change from baseline to Week 10 in BPI-SF Relations With Other People Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690594|NCT01118780|3108474|Superiority or Other||LS mean difference|0.38|Standard Error of the Mean|0.29||0.187|2-Sided|95.0|-0.19|0.94||The p-value is for the change from baseline to Week 10 in BPI-SF Normal Work Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690595|NCT01118780|3108474|Superiority or Other||LS mean difference|0.6|Standard Error of the Mean|0.29||0.04|2-Sided|95.0|0.03|1.18||The p-value is for the change from baseline to Week 10 in BPI-SF Walking Ability Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690596|NCT01118780|3108474|Superiority or Other||LS mean difference|0.41|Standard Error of the Mean|0.27||0.14|2-Sided|95.0|-0.13|0.95||The p-value is for the change from baseline to Week 10 in BPI-SF Mood Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690597|NCT01118780|3108474|Superiority or Other||LS mean difference|0.53|Standard Error of the Mean|0.29||0.066|2-Sided|95.0|-0.04|1.09||The p-value is for the change from baseline to Week 10 in BPI-SF General Activity Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690598|NCT01118780|3108474|Superiority or Other||LS mean difference|0.23|Standard Error of the Mean|0.25||0.371|2-Sided|95.0|-0.27|0.73||The p-value is for the change from baseline to Week 10 in BPI-SF Pain Right Now Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690599|NCT01118780|3108474|Superiority or Other||LS mean difference|0.42|Standard Error of the Mean|0.25||0.089|2-Sided|95.0|-0.06|0.91||The p-value is for the change from baseline to Week 10 in BPI-SF Average Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690600|NCT01118780|3108474|Superiority or Other||LS mean difference|0.42|Standard Error of the Mean|0.24||0.079|2-Sided|95.0|-0.05|0.89||The p-value is for the change from baseline to Week 10 in BPI-SF Least Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690601|NCT01118780|3108474|Superiority or Other||LS mean difference|0.55|Standard Error of the Mean|0.29||0.059|2-Sided|95.0|-0.02|1.11||The p-value is for the change from baseline to Week 10 in BPI-SF Worst Pain Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690602|NCT01118780|3108475|Superiority or Other||LS mean difference|0.62|Standard Error of the Mean|0.15|<|0.001|2-Sided|95.0|0.33|0.91|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690603|NCT01118780|3108476|Superiority or Other||LS mean difference|0.53|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|0.26|0.79|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690604|NCT01118780|3108477|Superiority or Other||LS mean difference|1.69|Standard Error of the Mean|0.41|<|0.001|2-Sided|95.0|0.89|2.49||The p-value is for the change from baseline to Week 10 in the HADS Depression Subscale Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690605|NCT01118780|3108477|Superiority or Other||LS mean difference|2.19|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|1.2|3.18||The p-value is for the change from baseline to Week 10 in the HADS Anxiety Subscale Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690606|NCT01118780|3108478|Superiority or Other||LS mean difference|0.31|Standard Error of the Mean|0.11||0.007|2-Sided|95.0|0.09|0.53||The p-value is for the change from baseline to Week 10 in the HAMA Tension Item Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690607|NCT01118780|3108478|Superiority or Other||LS mean difference|0.52|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|0.3|0.74||The p-value is for the change from baseline to Week 10 in the HAMA Anxious Mood Item Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690608|NCT01118780|3108478|Superiority or Other||LS mean difference|1.76|Standard Error of the Mean|0.45|<|0.001|2-Sided|95.0|0.87|2.65||The p-value is for the change from baseline to Week 10 in the HAMA Somatic Anxiety Factor Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690609|NCT01118780|3108478|Superiority or Other||LS mean difference|2.4|Standard Error of the Mean|0.49|<|0.001|2-Sided|95.0|1.43|3.37||The p-value is for the change from baseline to Week 10 in the HAMA Psychic Anxiety Factor Score.|Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690610|NCT01118780|3108479|Superiority or Other||LS mean difference|3.23|Standard Error of the Mean|0.82|<|0.001|2-Sided|95.0|1.61|4.85|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690611|NCT01118780|3108480|Superiority or Other||LS mean difference|4.17|Standard Error of the Mean|0.86|<|0.001|2-Sided|95.0|2.47|5.88|||Mixed Models Analysis||LS mean difference was calculated by placebo minus duloxetine. Positive values indicated improvement over placebo.||
1690637|NCT01118273|3108534|Superiority or Other|||||||0.001|||||||Log Rank||||
1690638|NCT01118273|3108535|Superiority or Other|||||||0.72|||||||ANCOVA||||
1690639|NCT01118273|3108536|Superiority or Other|||||||0.35|||||||ANCOVA||||
1690640|NCT01118273|3108537|Superiority or Other|||||||0.35|||||||ANCOVA||||
1690641|NCT01118273|3108538|Superiority or Other|||||||0.42|||||||ANCOVA||||
1690642|NCT01118273|3108540|Superiority or Other|||||||0.05|||||||Cochran-Mantel-Haenszel||||
1690643|NCT01118273|3108541|Superiority or Other|||||||0.95|||||||ANCOVA||||
1690644|NCT01118273|3108542|Superiority or Other|||||||0.04|||||||Cochran-Mantel-Haenszel||||
1690645|NCT01118273|3108543|Superiority or Other|||||||0.015|||||||ANCOVA||||
1690646|NCT01118273|3108544|Superiority or Other|||||||0.76|||||||Cochran-Mantel-Haenszel||||
1690647|NCT01118273|3108545|Superiority or Other|||||||0.03|||||||Cochran-Mantel-Haenszel||||
1690648|NCT01118273|3108546|Superiority or Other|||||||0.018|||||||ANCOVA||||
1690649|NCT01118273|3108547|Superiority or Other|||||||0.019|||||||ANCOVA||||
1690650|NCT01118273|3108548|Superiority or Other|||||||0.05|||||||ANCOVA||||
1690651|NCT01118273|3108549|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1690652|NCT01118273|3108550|Superiority or Other|||||||0.45|||||||Log Rank||||
1690653|NCT01118273|3108551|Superiority or Other|||||||0.31|||||||ANCOVA||||
1690654|NCT01118273|3108552|Superiority or Other|||||||0.54|||||||ANCOVA||||
1690655|NCT01117766|3108598|Superiority or Other||Mean Difference (Net)|-4.29|Standard Error of the Mean|6.292||0.4999|2-Sided|95.0|-17.13|8.54|||ANCOVA||||
1690656|NCT01117766|3108599|Superiority or Other||Mean Difference (Net)|-1.51|Standard Error of the Mean|0.588||0.0198|2-Sided|95.0|-2.75|-0.27|||ANCOVA|||Week 4 (Visits 4 and 7)|
1690657|NCT01117766|3108599|Superiority or Other||Mean Difference (Net)|-1.04|Standard Error of the Mean|0.722||0.1753|2-Sided|95.0|-2.6|0.53|||ANCOVA|||Week 3 (Visits 3 and 6)|
1690658|NCT01117766|3108600|Superiority or Other||Mean Difference (Net)|-1.54|Standard Error of the Mean|0.465||0.0022|2-Sided|95.0|-2.48|-0.59|||ANCOVA|||Week 4 (Visits 4 and 7)|
1690659|NCT01117766|3108600|Superiority or Other||Mean Difference (Net)|-0.19|Standard Error of the Mean|0.433||0.6631|2-Sided|95.0|-1.12|0.74|||ANCOVA|||Week 3 (Visits 3 and 6)|
1690660|NCT01117766|3108601|Superiority or Other||Mean Difference (Net)|-1.0|Standard Error of the Mean|0.467||0.0403|2-Sided|95.0|-1.95|-0.05|||ANCOVA||In statistical analyses, scores were further grouped to 1-3 ‘improved’, 4 ‘no change’ and 5-7 ‘worsened’.|Week 4 (Visits 4 and 7)|
1690661|NCT01117766|3108601|Superiority or Other||Mean Difference (Net)|-1.54|Standard Error of the Mean|0.586||0.0132|2-Sided|95.0|-2.73|-0.34|||ANCOVA||In statistical analyses, scores were further grouped to 1-3 ‘improved’, 4 ‘no change’ and 5-7 ‘worsened’.|Week 3 (Visits 3 and 6)|
1690662|NCT01117766|3108602|Superiority or Other||Mean Difference (Net)|-0.09|Standard Error of the Mean|0.5||0.8536|2-Sided|95.0|-1.15|0.96|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)|
1690663|NCT01117766|3108602|Superiority or Other||Mean Difference (Net)|0.39|Standard Error of the Mean|0.642||0.5502|2-Sided|95.0|-0.99|1.78|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)|
1690664|NCT01117766|3108603|Superiority or Other||Mean Difference (Net)|0.01|Standard Error of the Mean|0.299||0.9673|2-Sided|95.0|-0.61|0.64|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)|
1690665|NCT01117766|3108603|Superiority or Other||Mean Difference (Net)|0.15|Standard Error of the Mean|0.478||0.7506|2-Sided|95.0|-0.83|1.14|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)|
1690666|NCT01117766|3108604|Superiority or Other||Mean Difference (Net)|-49.06|Standard Error of the Mean|26.501||0.0844|2-Sided|95.0|-105.67|7.55|||ANCOVA|||Week 4 (Visits 4 and 7)|
1690667|NCT01117766|3108604|Superiority or Other||Mean Difference (Net)|-61.54|Standard Error of the Mean|25.298||0.03|2-Sided|95.0|-116.12|-6.96|||ANCOVA|||Week 3 (Visits 3 and 6)|
1690668|NCT01117766|3108605|Superiority or Other||Mean Difference (Net)|-0.59|Standard Error of the Mean|0.37||0.1294|2-Sided|95.0|-1.36|0.19|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 4 (Visits 4 and 7)|
1690669|NCT01117766|3108605|Superiority or Other||Mean Difference (Net)|-1.09|Standard Error of the Mean|0.342||0.0071|2-Sided|95.0|-1.84|-0.35|||ANCOVA|Statistical analysis was based on the average pain score across all levels of stimuli.||Week 3 (Visits 3 and 6)|
1690670|NCT01117766|3108606|Superiority or Other||Mean Difference (Net)|-23.91|Standard Error of the Mean|25.807||0.3678|2-Sided|95.0|-78.54|30.72|||ANCOVA|||Week 4 (Visits 4 and 7)|
1690671|NCT01117766|3108606|Superiority or Other||Mean Difference (Net)|-12.32|Standard Error of the Mean|26.872||0.6539|2-Sided|95.0|-70.2|45.56|||ANCOVA|||Week 3 (Visits 3 and 6)|
1690672|NCT01117766|3108607|Superiority or Other||Mean Difference (Net)|-0.52|Standard Error of the Mean|0.536||0.3404|2-Sided|95.0|-1.61|0.57|||ANCOVA|||Week 4 (Visits 4 and 7)|
1690673|NCT01117766|3108607|Superiority or Other||Mean Difference (Net)|-0.19|Standard Error of the Mean|0.537||0.7319|2-Sided|95.0|-1.29|0.92|||ANCOVA|||Week 3 (Visits 3 and 6)|
1690674|NCT01117454|3108635|Superiority|||||||0.008|||||||Wilcoxon (Mann-Whitney)|Wilcoxon signed rank with continuity correction|||
1690675|NCT01117428|3108638|Equivalence|Differences between Parts E and F in terms of Best Overall Response evaluated from screening until disease progression.||||||0.6645||||||No adjustment, 5% significance level|Fisher Exact||||
1690676|NCT01117350|3108656|Superiority or Other||Mean Difference (Final Values)|2.54||||0.439|2-Sided|95.0|-3.88|8.93||"If superiority not demonstrated, switching from superiority to non-inferiority considered.~Conclusion of non-inferiority reached if lower limit of 2-sided 95% confidence interval of the difference (insulin glargine – liraglutide) > or = to - 3.5%"|Chi-squared|||"Superiority testing~H0: Rate measured with insulin glargine = rate measured with liraglutide~H1: Rate measured with insulin glargine ≠ rate measured with liraglutide~Sample size calculation (465 randomized patients per arm) was based on the assumption of an expected success rate of 46% with insulin glargine and 35% with liraglutide, an alpha risk of 5% (2-sided) and a power of 90%, taking into account an estimated non evaluability rate of 10%."|
1690677|NCT01117337|3108657|Superiority or Other|||||||0.56|||||||Fisher Exact||||
1690678|NCT01117337|3108658|Superiority or Other|||||||0.2|||||||Fisher Exact||||
1690679|NCT01117051|3108676|Superiority or Other|||||||0.305|||||||Cochran-Mantel-Haenszel||||
1690680|NCT01116986|3108684|Superiority or Other||Odds Ratio (OR)|1.078||||0.389|2-Sided|95.0|0.909|1.278|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum vs. Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.|
1690681|NCT01116986|3108684|Superiority or Other||Odds Ratio (OR)|1.049||||0.587|2-Sided|95.0|0.883|1.246|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal Phone Counseling During the Quit Attempt vs. Intensive Phone Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.|
1690682|NCT01116986|3108684|Superiority or Other||Odds Ratio (OR)|1.056||||0.536|2-Sided|95.0|0.889|1.254|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., Minimal In-person Counseling During the Quit Attempt vs. Intensive In-person Counseling During the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.|
1690683|NCT01116986|3108684|Superiority or Other||Odds Ratio (OR)|1.196||||0.041|2-Sided|95.0|1.008|1.42|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt) would result in significantly higher abstinence at 16 weeks post-quit.|
1690684|NCT01116986|3108684|Superiority or Other||Odds Ratio (OR)|1.117||||0.207|2-Sided|95.0|0.941|1.325|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum) would result in significantly higher abstinence at 16 weeks post-quit.|
1690685|NCT01116986|3108684|Superiority or Other||Odds Ratio (OR)|1.087||||0.341|2-Sided|95.0|0.916|1.29|||Regression, Logistic|||The logistic regression model effects consisted of six treatment main effects and 15 two-way treatment interactions. The main effects provide direct tests of the primary aim of the study, i.e., determining whether or not more intensive treatments (compared to less intensive treatments; e.g., No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch) would result in significantly higher abstinence at 16 weeks post-quit.|
1690686|NCT01116986|3108685|Superiority or Other||Cox Proportional Hazard|1.031||||0.511|2-Sided|95.0|0.941|1.13|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).|
1690687|NCT01116986|3108685|Superiority or Other||Cox Proportional Hazard|0.983||||0.716|2-Sided|95.0|0.898|1.077|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).|
1690688|NCT01116986|3108685|Superiority or Other||Cox Proportional Hazard|0.925||||0.093|2-Sided|95.0|0.844|1.013|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).|
1690689|NCT01116986|3108685|Superiority or Other||Cox Proportional Hazard|0.989||||0.814|2-Sided|95.0|0.903|1.084|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).|
1690690|NCT01116986|3108685|Superiority or Other||Cox Proportional Hazard|0.98||||0.664|2-Sided|95.0|0.894|1.074|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).|
1690691|NCT01116986|3108685|Superiority or Other||Cox Proportional Hazard|0.954||||0.312|2-Sided|95.0|0.871|1.045|||Regression, Cox|||The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day).|
1690692|NCT01116921|3108692|Superiority or Other||Odds Ratio (OR)|0.3||||0.006|2-Sided|95.0|0.13|0.7|||Regression, Logistic||||
1690693|NCT01116895|3108697|Other||Least square mean difference|-6.7||||0.65|2-Sided|95.0|-36.2|22.8|||ANOVA||||
1690694|NCT01116895|3108697|Other||Least square mean difference|4.5||||0.77|2-Sided|95.0|-26.2|35.3|||ANOVA||||
1690695|NCT01116895|3108697|Other||Least square mean difference|-2.2||||0.89|2-Sided|95.0|-32.6|28.2|||ANOVA||||
1690696|NCT01116544|3108721|Superiority or Other (legacy)||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Both treatment groups combined|
1690697|NCT01116544|3108722|Superiority or Other (legacy)|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Data combined between 2 treatment groups|
1690698|NCT01116544|3108723|Superiority or Other (legacy)|||||||0.001||||||Across both treatment groups|ANCOVA||||
1690699|NCT01116544|3108724|Superiority or Other (legacy)|||||||0.001||||||Across both groups, whether score increased following completion of intervention|ANCOVA||||
1691104|NCT01112735|3109260|Superiority|||||||0.4598|||||||Wilcoxon (Mann-Whitney)|||Day 60|
1690700|NCT01116544|3108725|Non-Inferiority or Equivalence (legacy)|Power analysis called for sample sizes of 32 participants in each treatment group. The study was close before reaching this number of participants.|||||<|0.001||||||Hypothesis: significant increase in score (post-tx - pre-tx) for both groups|ANCOVA|FMA scores adjusted for baseline differences.|||
1690701|NCT01116544|3108726|Superiority or Other (legacy)||||||<|0.005||||||A priori threshold = 0.05|Wilcoxon (Mann-Whitney)||||
1690702|NCT01116427|3108733|Superiority or Other|||||||0.67||||||Wilcoxon rank sum test in which the change from baseline scores per participant were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)||||
1690703|NCT01116427|3108735|Superiority or Other|||||||0.29|||||||Fisher Exact||||
1690704|NCT01116427|3108736|Superiority or Other|||||||0.88||||||Wilcoxon rank sum test in which the percent brain volume change values per participant were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)||||
1690705|NCT01116427|3108737|Superiority or Other|||||||0.07||||||Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups|Wilcoxon (Mann-Whitney)||||
1690706|NCT01116427|3108738|Superiority or Other|||||||0.06||||||Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.|Wilcoxon (Mann-Whitney)||||
1690707|NCT01116427|3108739|Superiority or Other|||||||0.13||||||Wilcoxon rank sum test in which the change from baseline scores per subject were converted to ranks and compared between treatment groups|Wilcoxon (Mann-Whitney)||||
1690708|NCT01116427|3108741|Superiority or Other|||||||0.65|||||||Fisher Exact||||
1690709|NCT01116427|3108742|Superiority or Other|||||||0.21||||||Wilcoxon rank sum test in which mean numbers of new lesions per participant were converted to ranks and compared between groups|Wilcoxon (Mann-Whitney)||||
1690710|NCT01116427|3108743|Superiority or Other|||||||0.68||||||Wilcoxon rank sum test in which percent brain volume change values per participant were converted to ranks and the ranks were compared between groups|Wilcoxon (Mann-Whitney)||||
1690711|NCT01116427|3108744|Superiority or Other|||||||0.93||||||Rank sum test in which the lesion volume change values per participant were converted to ranks and compared between the treatment groups|Wilcoxon (Mann-Whitney)||||
1690712|NCT01116427|3108745|Superiority or Other|||||||0.36||||||Wilcoxon rank sum test in which the total number of new lesions were converted to ranks and then compared between groups|Wilcoxon (Mann-Whitney)||||
1690713|NCT01116427|3108746|Superiority or Other|||||||0.87||||||Analysis was stratified on the presence or absence of subclinical activity as demonstrated by a Gd-enhanced lesion on one MRI in the past year prior to enrollment.|Wilcoxon (Mann-Whitney)||||
1690714|NCT01116401|3108747|Superiority or Other||||||<|0.01|||||||Regression, Linear||||
1690715|NCT01116401|3108748|Superiority or Other|||||||0.007|||||||Regression, Linear||||
1690716|NCT01115998|3108775|Superiority or Other||||||>|0.1|||||||Wilcoxon Signed-Rank Test|||"Self Initiated Scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1690717|NCT01115998|3108775|Superiority or Other||||||>|0.1|||||||Wilcoxon Signed-Rank Test|||"Reactive scale~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1690718|NCT01115998|3108776|Superiority or Other|||||||0.28||||||The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"BID total score~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1690719|NCT01115998|3108776|Superiority or Other|||||||0.69||||||The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Personal-social total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1690720|NCT01115998|3108776|Superiority or Other|||||||0.57||||||The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Motor total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1690721|NCT01115998|3108776|Superiority or Other|||||||0.42||||||The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Communication total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1690722|NCT01115998|3108776|Superiority or Other|||||||0.38||||||The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Cognitive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1690723|NCT01115998|3108776|Superiority or Other|||||||0.92||||||The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Adaptive total~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1690724|NCT01115998|3108777|Superiority or Other|||||||0.45||||||The a priori alpha level was <0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Social function caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1690725|NCT01115998|3108777|Superiority or Other|||||||0.006|||||||Wilcoxon Signed-Rank Test|The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.||"Self-care caregiver assistance~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1690726|NCT01115998|3108777|Superiority or Other|||||||0.03||||||The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Mobility care giver assistance.~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1690727|NCT01115998|3108777|Superiority or Other|||||||0.38||||||The a priori alpha level was 0.10 and it was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Social function functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1691105|NCT01112735|3109260|Superiority|||||||0.8809|||||||Wilcoxon (Mann-Whitney)|||Day 28|
1690728|NCT01115998|3108777|Superiority or Other|||||||0.52||||||The a priori alpha level was <0.10 and was not adjusted for multiple comparisons|Wilcoxon Signed-Rank Test|||"Self-care functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1690729|NCT01115998|3108777|Superiority or Other|||||||0.02||||||The a priori alpha level was < 0.10 and was not adjusted for multiple comparisons.|Wilcoxon Signed-Rank Test|||"Mobility functional skills~Null hypothesis: The change scores of children in the power mobility and control groups will not differ from baseline to 12 months."|
1690730|NCT01115855|3108818|Superiority or Other||Least Square Mean Difference|-0.13|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.36|0.11||||||Change from baseline at Week 4 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690731|NCT01115855|3108818|Superiority or Other||Least Square Mean Difference|0.13|Standard Error of the Mean|0.38|||2-Sided|95.0|-0.63|0.89||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690732|NCT01115855|3108818|Superiority or Other||Least Square Mean Difference|0.2|Standard Error of the Mean|0.32|||2-Sided|90.0|-0.44|0.83||||||Change from baseline at Month 42 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690733|NCT01115855|3108818|Superiority or Other||Least Square Mean Difference|0.02|Standard Error of the Mean|0.26|||2-Sided|95.0|-0.5|0.54||||||Change from baseline at Month 37 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690734|NCT01115855|3108818|Superiority or Other||Least Square Mean Difference|-0.07|Standard Error of the Mean|0.26|||2-Sided|95.0|-0.57|0.44||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690735|NCT01115855|3108818|Superiority or Other||Least Square Mean Difference|-0.09|Standard Error of the Mean|0.2|||2-Sided|95.0|-0.49|0.31||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690736|NCT01115855|3108818|Superiority or Other||Least Square Mean Difference|-0.15|Standard Error of the Mean|0.2|||2-Sided|95.0|-0.55|0.25||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690737|NCT01115855|3108818|Superiority or Other||Least Square Mean Difference|-0.16|Standard Error of the Mean|0.2|||2-Sided|95.0|-0.56|0.24||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690738|NCT01115855|3108818|Superiority or Other||Least Square Mean Difference|0.02|Standard Error of the Mean|0.22|||2-Sided|95.0|-0.41|0.45||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690739|NCT01115855|3108818|Superiority or Other||Least Square Mean Difference|0.06|Standard Error of the Mean|0.17|||2-Sided|95.0|-0.27|0.39||||||Change from baseline at Month 13: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690740|NCT01115855|3108818|Superiority or Other||Least Square Mean Difference|-0.02|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.34|0.3||||||Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690741|NCT01115855|3108818|Superiority or Other||Least Square Mean Difference|0.08|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.21|0.37||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690742|NCT01115855|3108820|Superiority or Other||Least Square Mean Difference|-2.04|Standard Error of the Mean|28.85|||2-Sided|95.0|-58.91|54.83||||||Change from baseline at Month 13 :ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690743|NCT01115855|3108820|Superiority or Other||Least Square Mean Difference|-31.46|Standard Error of the Mean|96.48|||2-Sided|95.0|-221.17|158.24||||||Change from baseline at Month 48: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690744|NCT01115855|3108820|Superiority or Other||Least Square Mean Difference|-27.69|Standard Error of the Mean|107.06|||2-Sided|90.0|-238.31|182.93||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690745|NCT01115855|3108820|Superiority or Other||Least Square Mean Difference|-44.48|Standard Error of the Mean|103.29|||2-Sided|95.0|-247.11|158.15||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1691106|NCT01112735|3109260|Superiority|||||||0.7107|||||||Wilcoxon (Mann-Whitney)|||Day 14|
1690746|NCT01115855|3108820|Superiority or Other||Least Square Mean Difference|-40.79|Standard Error of the Mean|79.91|||2-Sided|95.0|-197.55|115.97||||||Change from baseline at Month 33: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690747|NCT01115855|3108820|Superiority or Other||Least Square Mean Difference|-21.05|Standard Error of the Mean|88.27|||2-Sided|95.0|-194.21|152.11||||||Change from baseline at Month 29: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690748|NCT01115855|3108820|Superiority or Other||Least Square Mean Difference|19.35|Standard Error of the Mean|88.95|||2-Sided|95.0|-230.01|268.71||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690749|NCT01115855|3108820|Superiority or Other||Least Square Mean Difference|-79.63|Standard Error of the Mean|67.42|||2-Sided|95.0|-211.88|52.63||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690750|NCT01115855|3108820|Superiority or Other||Least Square Mean Difference|-78.47|Standard Error of the Mean|72.78|||2-Sided|95.0|-221.25|64.31||||||Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690751|NCT01115855|3108820|Superiority or Other||Least Square Mean Difference|-12.57|Standard Error of the Mean|43.18|||2-Sided|95.0|-97.28|72.13||||||Change from baseline at Month 13 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690752|NCT01115855|3108820|Superiority or Other||Least Square Mean Difference|-24.94|Standard Error of the Mean|54.2|||2-Sided|95.0|-131.27|81.39||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690753|NCT01115855|3108820|Superiority or Other||Least Square Mean Difference|-61.53|Standard Error of the Mean|59.75|||2-Sided|95.0|-186.44|63.37||||||Change from baseline at Month 5: Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690754|NCT01115855|3108821|Superiority or Other||Least Square Mean Difference|3.18|Standard Error of the Mean|1.33|||2-Sided|95.0|0.56|5.8||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690755|NCT01115855|3108821|Superiority or Other||Least Square Mean Difference|4.13|Standard Error of the Mean|2.98|||2-Sided|95.0|-1.82|10.07||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690756|NCT01115855|3108821|Superiority or Other||Least Square Mean Difference|4.67|Standard Error of the Mean|2.31|||2-Sided|90.0|0.08|9.25||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690757|NCT01115855|3108821|Superiority or Other||Least Square Mean Difference|3.85|Standard Error of the Mean|1.94|||2-Sided|95.0|0.02|7.68||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690758|NCT01115855|3108821|Superiority or Other||Least Square Mean Difference|4.65|Standard Error of the Mean|1.92|||2-Sided|95.0|0.86|8.44||||||Change from baseline at Month 33 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690759|NCT01115855|3108821|Superiority or Other||Least Square Mean Difference|3.6|Standard Error of the Mean|1.85|||2-Sided|95.0|-0.06|7.25||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690760|NCT01115855|3108821|Superiority or Other||Least Square Mean Difference|3.44|Standard Error of the Mean|1.68|||2-Sided|95.0|0.12|6.75||||||Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690761|NCT01115855|3108821|Superiority or Other||Least Square Mean Difference|5.65|Standard Error of the Mean|1.67|||2-Sided|95.0|2.36|8.94||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690762|NCT01115855|3108821|Superiority or Other||Least Square Mean Difference|4.86|Standard Error of the Mean|1.54|||2-Sided|95.0|1.81|7.9||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690802|NCT01115855|3108837|Superiority or Other||Hazard Ratio (HR)|1.77|||||2-Sided|95.0|0.81|3.87||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30­-<50 ml/min/1.73 m^2, >­=50 ml/min/1.73 m^2) covariates.|
1691107|NCT01112735|3109260|Superiority|||||||0.5488|||||||Wilcoxon (Mann-Whitney)|||Day 7|
1690763|NCT01115855|3108821|Superiority or Other||Least Square Mean Difference|3.86|Standard Error of the Mean|1.39|||2-Sided|95.0|1.11|6.6||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690764|NCT01115855|3108821|Superiority or Other||Least Square Mean Difference|2.74|Standard Error of the Mean|1.36|||2-Sided|95.0|0.07|5.42||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690765|NCT01115855|3108821|Superiority or Other||Least Square Mean Difference|1.71|Standard Error of the Mean|1.14|||2-Sided|95.0|-0.55|3.96||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690766|NCT01115855|3108822|Superiority or Other||Least Square Mean Difference|-187.72|Standard Error of the Mean|240.96|||2-Sided|95.0|-662.67|287.23||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690767|NCT01115855|3108822|Superiority or Other||Least Square Mean Difference|-80.16|Standard Error of the Mean|11486.21|||2-Sided|95.0|-146026.28|145865.96||||||Change from baseline at Month 48 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690768|NCT01115855|3108822|Superiority or Other||Least Square Mean Difference|-212.25|Standard Error of the Mean|11073.11|||2-Sided|90.0|-22723.82|22299.33||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690769|NCT01115855|3108822|Superiority or Other||Least Square Mean Difference|-58.77|Standard Error of the Mean|12765.3|||2-Sided|95.0|-30160.25|30042.7||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690770|NCT01115855|3108822|Superiority or Other||Least Square Mean Difference|170.49|Standard Error of the Mean|10730.38|||2-Sided|95.0|-21375.69|21716.66||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690771|NCT01115855|3108822|Superiority or Other||Least Square Mean Difference|-245.23|Standard Error of the Mean|6698.57|||2-Sided|95.0|-85358.69|84868.22||||||Change from baseline at Month 29 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690772|NCT01115855|3108822|Superiority or Other||Least Square Mean Difference|23.86|Standard Error of the Mean|10794.85|||2-Sided|95.0|-21649.89|21697.6||||||Change from baseline at Month 25 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690773|NCT01115855|3108822|Superiority or Other||Least Square Mean Difference|-414.99|Standard Error of the Mean|3071.77|||2-Sided|95.0|-39445.52|38615.54||||||Change from baseline at Month 21 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690774|NCT01115855|3108822|Superiority or Other||Least Square Mean Difference|-664.09|Standard Error of the Mean|11059.62|||2-Sided|95.0|-141189.93|139861.75||||||Change from baseline at Month 17 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690775|NCT01115855|3108822|Superiority or Other||Least Square Mean Difference|-370.14|Standard Error of the Mean|699.58|||2-Sided|95.0|-1742.51|1002.22||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690776|NCT01115855|3108822|Superiority or Other||Least Square Mean Difference|-247.14|Standard Error of the Mean|711.26|||2-Sided|95.0|-1642.43|1148.14||||||Change from baseline at Month 9 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690777|NCT01115855|3108822|Superiority or Other||Least Square Mean Difference|-364.65|Standard Error of the Mean|763.83|||2-Sided|95.0|-1863.06|1133.76||||||Change from baseline at Month 5 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690778|NCT01115855|3108823|Superiority or Other||Least Square Mean Difference|-102.3|Standard Error of the Mean|35.67|||2-Sided|95.0|-172.61|-32.0||||||Change from baseline at Month 13 : ANCOVA with treatment effect and covariates of the NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690779|NCT01115855|3108823|Superiority or Other||Least Square Mean Difference|-77.26|Standard Error of the Mean|966.09|||2-Sided|95.0|-2131.88|1977.37||||||Change from baseline at Month 48 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690803|NCT01115855|3108838|Superiority or Other||Hazard Ratio (HR)|0.86|||||2-Sided|95.0|0.56|1.31||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30­-<50 ml/min/1.73 m^2, >­=50 ml/min/1.73 m^2) covariates.|
1691108|NCT01112735|3109260|Superiority|||||||0.9417|||||||Wilcoxon (Mann-Whitney)|||Day 3|
1690780|NCT01115855|3108823|Superiority or Other||Least Square Mean Difference|-144.6|Standard Error of the Mean|200.56|||2-Sided|90.0|-2692.95|2403.76||||||Change from baseline at Month 42 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690781|NCT01115855|3108823|Superiority or Other||Least Square Mean Difference|-119.62|Standard Error of the Mean|158.84|||2-Sided|95.0|-2137.82|1898.59||||||Change from baseline at Month 37 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690782|NCT01115855|3108823|Superiority or Other||Least Square Mean Difference|-110.78|Standard Error of the Mean|92.42|||2-Sided|95.0|-307.49|85.93||||||Change from baseline at Month 33 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690783|NCT01115855|3108823|Superiority or Other||Least Square Mean Difference|-101.5|Standard Error of the Mean|61.05|||2-Sided|95.0|-267.36|64.36||||||Change from baseline at Month 29 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690784|NCT01115855|3108823|Superiority or Other||Least Square Mean Difference|-117.18|Standard Error of the Mean|51.76|||2-Sided|95.0|-221.49|-12.87||||||Change from baseline at Month 25 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690785|NCT01115855|3108823|Superiority or Other||Least Square Mean Difference|-132.39|Standard Error of the Mean|52.77|||2-Sided|95.0|-240.94|-23.84||||||Change from baseline at Month 21 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690786|NCT01115855|3108823|Superiority or Other||Least Square Mean Difference|-31.94|Standard Error of the Mean|51.12|||2-Sided|95.0|-232.77|-31.11||||||Change from baseline at Month 17 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690787|NCT01115855|3108823|Superiority or Other||Least Square Mean Difference|-125.09|Standard Error of the Mean|35.15|||2-Sided|95.0|-195.5|-54.68||||||Change from baseline at Month 13 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690788|NCT01115855|3108823|Superiority or Other||Least Square Mean Difference|-95.77|Standard Error of the Mean|44.54|||2-Sided|95.0|-184.51|-7.04||||||Change from baseline at Month 9 :Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690789|NCT01115855|3108823|Superiority or Other||Least Square Mean Difference|-102.93|Standard Error of the Mean|47.13|||2-Sided|95.0|-195.92|-9.94||||||Change from baseline at Month 5 : Mixed effect model of repeated measurements with covariates of the treatment, Week, interaction between treatment and week, baseline NYHA cohort (II, III/IV), baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) and baseline value.|
1690790|NCT01115855|3108825|Superiority or Other||Hazard Ratio (HR)|1.13|||||2-Sided|95.0|0.16|8.04||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30-­<50 ml/min/1.73 m^2, >­=50 ml/min/1.73 m^2) covariates.|
1690791|NCT01115855|3108826|Superiority or Other||Hazard Ratio (HR)|0.51|||||2-Sided|95.0|0.05|5.66||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30­-<50 ml/min/1.73 m^2, >­=50 ml/min/1.73 m^2) covariates.|
1690792|NCT01115855|3108827|Superiority or Other||Hazard Ratio (HR)|2.11|||||2-Sided|95.0|0.39|11.56||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30-­<50 ml/min/1.73 m^2, >­=50 ml/min/1.73 m^2) covariates.|
1690793|NCT01115855|3108828|Superiority or Other||Hazard Ratio (HR)|1.11|||||2-Sided|95.0|0.07|17.85||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30-­<50 ml/min/1.73 m^2, >­=50 ml/min/1.73 m^2) covariates.|
1690794|NCT01115855|3108829|Superiority or Other||Hazard Ratio (HR)|0.79|||||2-Sided|95.0|0.18|3.53||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30-­<50 ml/min/1.73 m^2, >­=50 ml/min/1.73 m^2) covariates.|
1690795|NCT01115855|3108830|Superiority or Other||Hazard Ratio (HR)|0.83|||||2-Sided|95.0|0.53|1.28||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30-­<50 ml/min/1.73 m^2, >­=50 ml/min/1.73 m^2) covariates.|
1690796|NCT01115855|3108831|Superiority or Other||Hazard Ratio (HR)|0.7|||||2-Sided|95.0|0.45|1.1||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30­-<50 ml/min/1.73 m^2, >­=50 ml/min/1.73 m^2) covariates.|
1690797|NCT01115855|3108832|Superiority or Other||Hazard Ratio (HR)|0.81|||||2-Sided|95.0|0.49|1.33||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30-­<50 ml/min/1.73 m^2, >=­50 ml/min/1.73 m^2) covariates.|
1690798|NCT01115855|3108833|Superiority or Other||Hazard Ratio (HR)|0.66|||||2-Sided|95.0|0.45|0.97||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30-­<50 ml/min/1.73 m^2, >­=50 ml/min/1.73 m^2) covariates.|
1690799|NCT01115855|3108834|Superiority or Other||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.45|1.25||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30­-<50 ml/min/1.73 m^2, >­=50 ml/min/1.73 m^2) covariates.|
1690800|NCT01115855|3108835|Superiority or Other||Hazard Ratio (HR)|0.65|||||2-Sided|95.0|0.44|0.97||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30­-<50 ml/min/1.73 m^2, >­=50 ml/min/1.73 m^2) covariates.|
1690801|NCT01115855|3108836|Superiority or Other||Hazard Ratio (HR)|2.4|||||2-Sided|95.0|0.92|6.24||||||Cox Proportional Hazard Model with baseline NYHA cohort (II, III/IV) and baseline eGFR (30-­<50 ml/min/1.73 m^2, >­=50 ml/min/1.73 m^2) covariates.|
1690804|NCT01115855|3108839|Superiority or Other||Hazard Ratio (HR)|0.85|||||2-Sided|95.0|0.53|1.36||||||Cox Proportional Hazard Model with baseline New York Heart Association (NYHA) cohort (II, III/IV) and baseline eGFR (30-<50 ml/min/1.73 m^2, >=50 ml/min/1.73 m^2) covariates.|
1690805|NCT01115738|3108848|Superiority or Other||Mean Difference (Final Values)|11.7||||0.6229|2-Sided|95.0|-35.43|58.83|||ANOVA|||A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.|
1690806|NCT01115738|3108848|Superiority or Other||Mean Difference (Final Values)|-3.435||||0.8913|2-Sided|95.0|-53.23|46.37|||ANOVA|||A linear ANOVA model with PRU values of 6 hours Post-Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.|
1690807|NCT01115738|3108848|Superiority or Other||Mean Difference (Final Values)|-8.714||||0.7875|2-Sided|95.0|-72.78|55.36|||ANOVA|||A linear ANOVA model with PRU values of 6 hours post Prasugrel LD as response and treatment, CYP2C19 metabolizer status, interaction of treatment-by-CYP2C19 metabolizer status as fixed effects.|
1690808|NCT01115738|3108849|Superiority or Other||Mean Difference (Final Values)|3.449||||0.8711|2-Sided|95.0|-38.81|45.71|||ANOVA|||A linear ANOVA model with PRU values at baseline for clopidogrel treated participants as response and CYP2C19 metabolizer status as covariate of main interest.|
1690809|NCT01115738|3108852|Superiority or Other||Mean Difference (Final Values)|0.31||||0.942|2-Sided|95.0|-8.09|8.71||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690810|NCT01115738|3108852|Superiority or Other||Mean Difference (Final Values)|-5.03||||0.247|2-Sided|95.0|-13.58|3.52||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690811|NCT01115738|3108852|Superiority or Other||Median Difference (Final Values)|-0.99||||0.842|2-Sided|95.0|-10.85|8.86||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690812|NCT01115738|3108852|Superiority or Other||Mean Difference (Final Values)|-10.07||||0.049|2-Sided|95.0|-20.11|-0.04||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690813|NCT01115738|3108852|Superiority or Other||Mean Difference (Final Values)|1.33||||0.808|2-Sided|95.0|-9.44|12.1||P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690814|NCT01115738|3108852|Superiority or Other||Mean Difference (Final Values)|-6.89||||0.223|2-Sided|95.0|-18.02|4.24||P-value is for 6 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690815|NCT01115738|3108852|Superiority or Other||Mean Difference (Final Values)|1.15||||0.89|2-Sided|95.0|-15.24|17.53||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690816|NCT01115738|3108852|Superiority or Other||Mean Difference (Final Values)|-2.71||||0.749|2-Sided|95.0|-19.44|14.02||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690817|NCT01115738|3108852|Superiority or Other||Mean Difference (Final Values)|-5.23||||0.278|2-Sided|95.0|-14.74|4.27||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690818|NCT01115738|3108852|Superiority or Other||Mean Difference (Final Values)|-3.31||||0.505|2-Sided|95.0|-13.1|6.48||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690819|NCT01115738|3108855|Superiority or Other||Mean Difference (Final Values)|-3.34||||0.777|2-Sided|95.0|-26.62|19.94||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690820|NCT01115738|3108855|Superiority or Other||Mean Difference (Final Values)|8.87||||0.463|2-Sided|95.0|-14.96|32.71||P-value is for 72 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1691020|NCT01114737|3109001|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.8||0.522|2-Sided|95.0|-1.1|2.2|||ANCOVA|Adjusted for Baseline Hamilton Rating Scale For Depression (HAM-D) Score, ADHD symptom, and ADHD medication.|||
1690821|NCT01115738|3108855|Superiority or Other||Mean Difference (Final Values)|11.3||||0.436|2-Sided|95.0|-17.29|39.9||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690822|NCT01115738|3108855|Superiority or Other||Mean Difference (Final Values)|28.69||||0.054|2-Sided|95.0|-0.47|57.84||P-value is for 24 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690823|NCT01115738|3108855|Superiority or Other||Mean Difference (Final Values)|5.45||||0.823|2-Sided|95.0|-42.53|53.44||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690824|NCT01115738|3108855|Superiority or Other||Mean Difference (Final Values)|9.45||||0.703|2-Sided|95.0|-39.55|58.45||P-value is for 2 hours after prasugrel LD. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690825|NCT01115738|3108855|Superiority or Other||Mean Difference (Final Values)|35.89||||0.052|2-Sided|95.0|-0.29|72.06||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690826|NCT01115738|3108855|Superiority or Other||Mean Difference (Final Values)|16.93||||0.37|2-Sided|95.0|-20.26|54.12||P-value is for Baseline. P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690827|NCT01115738|3108856|Superiority or Other||Mean Difference (Final Values)|3.93||||0.809|2-Sided|95.0|-28.2|36.07||P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690828|NCT01115738|3108856|Superiority or Other||Mean Difference (Final Values)|22.24||||0.188|2-Sided|95.0|-10.98|55.47||P-values were not adjusted for multiplicity. P-values <0.05 were considered statistically significant.|Mixed Model Repeated Measures Analysis|Fixed effects were Treatment, Visit, Country, Treatment-by-Visit. Participants and Error were Random Effects. Covariance structure was Unstructured.|||
1690829|NCT01115673|3108859|Superiority or Other||Mean Difference (Final Values)|1.35|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690830|NCT01115673|3108859|Superiority or Other||Mean Difference (Final Values)|0.33|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690831|NCT01115673|3108859|Superiority or Other||Mean Difference (Final Values)|1.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690832|NCT01115673|3108860|Superiority or Other||Odds Ratio (OR)|11.16|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690833|NCT01115673|3108860|Superiority or Other||Odds Ratio (OR)|1.65|||<|0.006||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690834|NCT01115673|3108860|Superiority or Other||Odds Ratio (OR)|18.45|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690835|NCT01115673|3108861|Superiority or Other||Odds Ratio (OR)|0.21|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690836|NCT01115673|3108861|Superiority or Other||Odds Ratio (OR)|0.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690837|NCT01115673|3108861|Superiority or Other||Odds Ratio (OR)|0.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690838|NCT01115673|3108862|Superiority or Other||Odds Ratio (OR)|0.12|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690839|NCT01115673|3108862|Superiority or Other||Odds Ratio (OR)|0.52|||<|0.002||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1691109|NCT01112735|3109261|Superiority|||||||0.3595|||||||Wilcoxon (Mann-Whitney)||||
1690840|NCT01115673|3108862|Superiority or Other||Odds Ratio (OR)|0.06|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|Cochran-Mantel-Haenszel|Stratified by categorical baseline pain rating.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690841|NCT01115673|3108863|Superiority or Other||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.|
1690842|NCT01115673|3108863|Superiority or Other||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.|
1690843|NCT01115673|3108863|Superiority or Other||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves.|Log Rank|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.|
1690844|NCT01115673|3108864|Superiority or Other||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690845|NCT01115673|3108864|Superiority or Other||||||<|0.934||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690846|NCT01115673|3108864|Superiority or Other||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690847|NCT01115673|3108865|Superiority or Other||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690848|NCT01115673|3108865|Superiority or Other||||||<|0.26||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690849|NCT01115673|3108865|Superiority or Other||||||<|0.001||||||The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves.|Wilcoxon test, from SAS PROC LIFETEST|||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690850|NCT01115673|3108866|Superiority or Other||Mean Difference (Final Values)|45.41|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690851|NCT01115673|3108866|Superiority or Other||Mean Difference (Final Values)|20.98|||<|0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690852|NCT01115673|3108866|Superiority or Other||Mean Difference (Final Values)|66.39|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690853|NCT01115673|3108867|Superiority or Other||Mean Difference (Final Values)|53.94|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690854|NCT01115673|3108867|Superiority or Other||Mean Difference (Final Values)|22.5|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690855|NCT01115673|3108867|Superiority or Other||Mean Difference (Final Values)|76.44|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690856|NCT01115673|3108868|Superiority or Other||Mean Difference (Final Values)|63.44|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690857|NCT01115673|3108868|Superiority or Other||Mean Difference (Final Values)|22.39|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690858|NCT01115673|3108868|Superiority or Other||Mean Difference (Final Values)|85.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690859|NCT01115673|3108869|Superiority or Other||Mean Difference (Final Values)|71.35|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690860|NCT01115673|3108869|Superiority or Other||Mean Difference (Final Values)|18.87|||<|0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690861|NCT01115673|3108869|Superiority or Other||Mean Difference (Final Values)|90.22|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690862|NCT01115673|3108870|Superiority or Other||Mean Difference (Final Values)|81.23|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690863|NCT01115673|3108870|Superiority or Other||Mean Difference (Final Values)|18.6|||<|0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690864|NCT01115673|3108870|Superiority or Other||Mean Difference (Final Values)|99.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690865|NCT01115673|3108871|Superiority or Other||Mean Difference (Final Values)|81.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690866|NCT01115673|3108871|Superiority or Other||Mean Difference (Final Values)|13.08|||<|0.024||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690867|NCT01115673|3108871|Superiority or Other||Mean Difference (Final Values)|94.8|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690868|NCT01115673|3108872|Superiority or Other||Mean Difference (Final Values)|82.2|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690869|NCT01115673|3108872|Superiority or Other||Mean Difference (Final Values)|11.46|||<|0.043||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690870|NCT01115673|3108872|Superiority or Other||Mean Difference (Final Values)|93.66|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690871|NCT01115673|3108873|Superiority or Other||Mean Difference (Final Values)|78.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690872|NCT01115673|3108873|Superiority or Other||Mean Difference (Final Values)|8.21|||<|0.138||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690873|NCT01115673|3108873|Superiority or Other||Mean Difference (Final Values)|86.71|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690874|NCT01115673|3108874|Superiority or Other||Mean Difference (Final Values)|69.49|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690875|NCT01115673|3108874|Superiority or Other||Mean Difference (Final Values)|2.38|||<|0.653||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690876|NCT01115673|3108874|Superiority or Other||Mean Difference (Final Values)|71.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690877|NCT01115673|3108875|Superiority or Other||Mean Difference (Final Values)|46.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690878|NCT01115673|3108875|Superiority or Other||Mean Difference (Final Values)|-0.45|||<|0.923||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690879|NCT01115673|3108875|Superiority or Other||Mean Difference (Final Values)|45.65|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690880|NCT01115673|3108876|Superiority or Other||Mean Difference (Final Values)|12.14||||0.005||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1691110|NCT01112735|3109262|Superiority|||||||0.5621|||||||Wilcoxon (Mann-Whitney)||||
1690881|NCT01115673|3108876|Superiority or Other||Mean Difference (Final Values)|-2.49||||0.365||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690882|NCT01115673|3108876|Superiority or Other||Mean Difference (Final Values)|9.65||||0.027||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690883|NCT01115673|3108877|Superiority or Other||Mean Difference (Final Values)|22.55|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690884|NCT01115673|3108877|Superiority or Other||Mean Difference (Final Values)|11.4|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690885|NCT01115673|3108877|Superiority or Other||Mean Difference (Final Values)|33.94|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690886|NCT01115673|3108878|Superiority or Other||Mean Difference (Final Values)|26.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690887|NCT01115673|3108878|Superiority or Other||Mean Difference (Final Values)|11.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690888|NCT01115673|3108878|Superiority or Other||Mean Difference (Final Values)|38.4|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690889|NCT01115673|3108879|Superiority or Other||Mean Difference (Final Values)|32.02|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690890|NCT01115673|3108879|Superiority or Other||Mean Difference (Final Values)|11.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690891|NCT01115673|3108879|Superiority or Other||Mean Difference (Final Values)|43.84|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690892|NCT01115673|3108880|Superiority or Other||Mean Difference (Final Values)|36.75|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690893|NCT01115673|3108880|Superiority or Other||Mean Difference (Final Values)|10.04|||<|0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690894|NCT01115673|3108880|Superiority or Other||Mean Difference (Final Values)|46.8|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690895|NCT01115673|3108881|Superiority or Other||Mean Difference (Final Values)|42.84|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690896|NCT01115673|3108881|Superiority or Other||Mean Difference (Final Values)|9.52|||<|0.003||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690897|NCT01115673|3108881|Superiority or Other||Mean Difference (Final Values)|52.36|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690898|NCT01115673|3108882|Superiority or Other||Mean Difference (Final Values)|43.1|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690899|NCT01115673|3108882|Superiority or Other||Mean Difference (Final Values)|6.74|||<|0.032||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690900|NCT01115673|3108882|Superiority or Other||Mean Difference (Final Values)|49.83|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690901|NCT01115673|3108883|Superiority or Other||Mean Difference (Final Values)|43.65|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1691218|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Constipation at week 12|
1690902|NCT01115673|3108883|Superiority or Other||Mean Difference (Final Values)|6.04|||<|0.05||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690903|NCT01115673|3108883|Superiority or Other||Mean Difference (Final Values)|49.69|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690904|NCT01115673|3108884|Superiority or Other||Mean Difference (Final Values)|41.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690905|NCT01115673|3108884|Superiority or Other||Mean Difference (Final Values)|4.33|||<|0.155||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690906|NCT01115673|3108884|Superiority or Other||Mean Difference (Final Values)|46.15|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690907|NCT01115673|3108885|Superiority or Other||Mean Difference (Final Values)|36.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690908|NCT01115673|3108885|Superiority or Other||Mean Difference (Final Values)|1.32|||<|0.655||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690909|NCT01115673|3108885|Superiority or Other||Mean Difference (Final Values)|38.19|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690910|NCT01115673|3108886|Superiority or Other||Mean Difference (Final Values)|25.11|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690911|NCT01115673|3108886|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.907||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690912|NCT01115673|3108886|Superiority or Other||Mean Difference (Final Values)|24.81|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690913|NCT01115673|3108887|Superiority or Other||Mean Difference (Final Values)|6.48||||0.008||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690914|NCT01115673|3108887|Superiority or Other||Mean Difference (Final Values)|-1.13||||0.462||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690915|NCT01115673|3108887|Superiority or Other||Mean Difference (Final Values)|5.35||||0.028||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690916|NCT01115673|3108888|Superiority or Other||Mean Difference (Final Values)|22.87|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690917|NCT01115673|3108888|Superiority or Other||Mean Difference (Final Values)|9.58|||<|0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690918|NCT01115673|3108888|Superiority or Other||Mean Difference (Final Values)|32.45|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690919|NCT01115673|3108889|Superiority or Other||Mean Difference (Final Values)|27.22|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690920|NCT01115673|3108889|Superiority or Other||Mean Difference (Final Values)|10.82|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690921|NCT01115673|3108889|Superiority or Other||Mean Difference (Final Values)|38.04|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690922|NCT01115673|3108890|Superiority or Other||Mean Difference (Final Values)|31.42|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1691219|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Vomiting at week 12|
1690923|NCT01115673|3108890|Superiority or Other||Mean Difference (Final Values)|10.57|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690924|NCT01115673|3108890|Superiority or Other||Mean Difference (Final Values)|41.99|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690925|NCT01115673|3108891|Superiority or Other||Mean Difference (Final Values)|34.59|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690926|NCT01115673|3108891|Superiority or Other||Mean Difference (Final Values)|8.83|||<|0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690927|NCT01115673|3108891|Superiority or Other||Mean Difference (Final Values)|43.42|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690928|NCT01115673|3108892|Superiority or Other||Mean Difference (Final Values)|38.38|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690929|NCT01115673|3108892|Superiority or Other||Mean Difference (Final Values)|9.08|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690930|NCT01115673|3108892|Superiority or Other||Mean Difference (Final Values)|47.46|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690931|NCT01115673|3108893|Superiority or Other||Mean Difference (Final Values)|38.63|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690932|NCT01115673|3108893|Superiority or Other||Mean Difference (Final Values)|6.34|||<|0.02||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690933|NCT01115673|3108893|Superiority or Other||Mean Difference (Final Values)|44.97|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690934|NCT01115673|3108894|Superiority or Other||Mean Difference (Final Values)|38.55|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690935|NCT01115673|3108894|Superiority or Other||Mean Difference (Final Values)|5.42|||<|0.041||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690936|NCT01115673|3108894|Superiority or Other||Mean Difference (Final Values)|43.97|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690937|NCT01115673|3108895|Superiority or Other||Mean Difference (Final Values)|36.67|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690938|NCT01115673|3108895|Superiority or Other||Mean Difference (Final Values)|3.88|||<|0.13||95.0||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690939|NCT01115673|3108895|Superiority or Other||Mean Difference (Final Values)|40.56|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690940|NCT01115673|3108896|Superiority or Other||Mean Difference (Final Values)|32.62|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690941|NCT01115673|3108896|Superiority or Other||Mean Difference (Final Values)|1.06|||<|0.661||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690942|NCT01115673|3108896|Superiority or Other||Mean Difference (Final Values)|33.68|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690943|NCT01115673|3108897|Superiority or Other||Mean Difference (Final Values)|20.99|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1691220|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Diarrhea at week 12|
1690944|NCT01115673|3108897|Superiority or Other||Mean Difference (Final Values)|-0.14|||<|0.946||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690945|NCT01115673|3108897|Superiority or Other||Mean Difference (Final Values)|20.85|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690946|NCT01115673|3108898|Superiority or Other||Mean Difference (Final Values)|5.66||||0.006||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690947|NCT01115673|3108898|Superiority or Other||Mean Difference (Final Values)|-1.36||||0.294||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690948|NCT01115673|3108898|Superiority or Other||Mean Difference (Final Values)|4.3||||0.037||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690949|NCT01115673|3108899|Superiority or Other||Mean Difference (Final Values)|188.72|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690950|NCT01115673|3108899|Superiority or Other||Mean Difference (Final Values)|53.95|||<|0.002||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690951|NCT01115673|3108899|Superiority or Other||Mean Difference (Final Values)|242.67|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690952|NCT01115673|3108900|Superiority or Other||Mean Difference (Final Values)|178.56|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690953|NCT01115673|3108900|Superiority or Other||Mean Difference (Final Values)|48.14|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690954|NCT01115673|3108900|Superiority or Other||Mean Difference (Final Values)|226.7|||<|0.001||||||The significance threshold level was 0.05 (two-sided).|ANOVA|Treatment and baseline pain categorical ratings were factors.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1690955|NCT01115673|3108901|Superiority or Other||Mean Difference (Final Values)|367.28|||<|0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.|
1690956|NCT01115673|3108901|Superiority or Other||Mean Difference (Final Values)|102.09|||<|0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.|
1690957|NCT01115673|3108901|Superiority or Other||Mean Difference (Final Values)|469.37|||<|0.001|||||||ANOVA|Treatment and baseline pain categorical ratings were factors.|SPRID6 = 0.25 times (PRID at 15 min + PRID at 30 min + PRID at 45 min + PRID at 60 min + PRID at 75 min + PRID at 90 min) + 0.5 times (PRID at 120 minutes) + PRID at 3 hours + PRID at 4 hours + PRID at 5 hours + PRID at 6 hours.|First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.|
1690958|NCT01115452|3108923|Superiority or Other||Adjusted mean difference|0.57||||0.8867|2-Sided|95.0|-7.39|8.54||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690959|NCT01115452|3108923|Superiority or Other||Adjusted mean difference|-0.15||||0.9705|2-Sided|95.0|-8.13|7.83||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1691021|NCT01114737|3109002|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|1.0||0.733|2-Sided|95.0|-2.4|1.7|||ANCOVA|Adjusted for Baseline Hamilton Anxiety Rating Scale (HAM-A) Score, ADHD symptom, and ADHD medication.|||
1691221|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Weakness/Fainting at week 12|
1690960|NCT01115452|3108923|Superiority or Other||Adjusted mean difference|-0.72||||0.8549|2-Sided|95.0|-8.54|7.1||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Investigator applied the participants with 5% potassium nitrate solution on each of the three individual sensitive tooth for two minutes (mins), in each of the five day treatment period|Null hypothesis is no difference between treatments.|
1690961|NCT01115452|3108924|Superiority or Other||Adjusted mean difference|2.41||||0.5507|2-Sided|95.0|-5.56|10.37||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690962|NCT01115452|3108924|Superiority or Other||Adjusted mean difference|1.05||||0.7949|2-Sided|95.0|-6.93|9.03||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690963|NCT01115452|3108924|Superiority or Other||Adjusted mean difference|-1.36||||0.7318|2-Sided|95.0|-9.18|6.46||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690964|NCT01115452|3108925|Superiority or Other||Adjusted mean difference|1.44||||0.7208|2-Sided|95.0|-6.52|9.41||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690965|NCT01115452|3108925|Superiority or Other||Adjusted mean difference|1.12||||0.7822|2-Sided|95.0|-6.86|9.1||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690966|NCT01115452|3108926|Superiority or Other||Adjusted mean difference|4.75||||0.2508|2-Sided|95.0|-3.4|12.9||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690967|NCT01115452|3108926|Superiority or Other||Adjusted mean difference|-0.39||||0.9248|2-Sided|95.0|-8.56|7.77||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690968|NCT01115452|3108926|Superiority or Other||Adjusted mean difference|-5.14||||0.2059|2-Sided|95.0|-13.14|2.86||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690969|NCT01115452|3108927|Superiority or Other||Adjusted mean difference|-2.18||||0.5969|2-Sided|95.0|-10.33|5.97||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690970|NCT01115452|3108927|Superiority or Other||Adjusted mean difference|1.04||||0.8008|2-Sided|95.0|-7.42|9.21||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution|Null hypothesis is no difference between treatments.|
1690971|NCT01115452|3108927|Superiority or Other||Adjusted mean difference|3.23||||0.4264||95.0|-4.77|11.23||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1691022|NCT01114737|3109003|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|2.8||0.953|2-Sided|95.0|-5.5|5.8|||ANCOVA|Adjusted for Baseline ADHD-RS/ASRS Total Score, ADHD symptom, and ADHD medication.|||
1696345|NCT01034397|3118723|Superiority or Other|||||||0.007|||||||t-test, 1 sided||||
1690972|NCT01115452|3108928|Superiority or Other||Adjusted mean difference|4.12||||0.3193|2-Sided|95.0|-4.03|12.27||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690973|NCT01115452|3108928|Superiority or Other||Adjusted mean difference|0.74||||0.8573|2-Sided|95.0|-7.42|8.91||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690974|NCT01115452|3108928|Superiority or Other||Adjusted mean difference|-3.37||||0.4055|2-Sided|95.0|-11.37|4.63||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690975|NCT01115452|3108929|Superiority or Other||Adjusted mean difference|2.75||||0.5321|2-Sided|95.0|-5.93|11.43||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution|Null hypothesis is no difference between treatments.|
1690976|NCT01115452|3108929|Superiority or Other||Adjusted mean difference|0.6||||0.8912|2-Sided|95.0|-8.1|9.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690977|NCT01115452|3108929|Superiority or Other||Adjusted mean difference|-2.15||||0.6192|2-Sided|95.0|-10.67|6.38||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690978|NCT01115452|3108930|Superiority or Other||Adjusted mean difference|0.48||||0.9127|2-Sided|95.0|-8.2|9.16|||ANCOVA|No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690979|NCT01115452|3108930|Superiority or Other||Adjusted mean difference|-2.1||||0.634|2-Sided|95.0|-10.8|6.6||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690980|NCT01115452|3108930|Superiority or Other||Adjusted mean difference|-2.58||||0.5504|2-Sided|95.0|-11.1|5.95||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690981|NCT01115452|3108931|Superiority or Other||Adjusted mean difference|0.32||||0.9428|2-Sided|95.0|-8.37|9.0||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690982|NCT01115452|3108931|Superiority or Other||Adjusted mean difference|-1.76||||0.6888|2-Sided|95.0|-10.46|6.93||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690983|NCT01115452|3108931|Superiority or Other||Adjusted mean difference|-2.08||||0.6301||95.0|-10.6|6.45||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1691023|NCT01114737|3109004|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|1.7||0.443|2-Sided|95.0|-2.1|4.7|||ANCOVA|Adjusted for Week 13 BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.|||
1691024|NCT01114737|3109005|Superiority or Other||Mean Difference (Final Values)|1.6|Standard Error of the Mean|1.8||0.395|2-Sided|95.0|-2.1|5.2|||ANCOVA|Adjusted for Week 13 BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.|||
1690984|NCT01115452|3108932|Superiority or Other||Adjustes mean difference|1.88||||0.6591|2-Sided|95.0|-6.52|10.28||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690985|NCT01115452|3108932|Superiority or Other||Adjusted mean difference|-1.7||||0.6896|2-Sided|95.0|-10.12|6.71||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690986|NCT01115452|3108932|Superiority or Other||Adjusted mean difference|-3.58||||0.393|2-Sided|95.0|-11.65|4.68||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690987|NCT01115452|3108933|Superiority or Other||Adjusted mean difference|2.38||||0.5766||95.0|-6.02|10.78||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690988|NCT01115452|3108933|Superiority or Other||Adjusted mean difference|0.43||||0.92|2-Sided|95.0|-7.99|8.85||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690989|NCT01115452|3108933|Superiority or Other||Adjusted mean difference|-1.95||||0.6417|2-Sided|95.0|-10.22|6.32||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690990|NCT01115452|3108934|Superiority or Other||Adjusted mean difference|2.01||||0.6367||95.0|-6.39|10.42||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690991|NCT01115452|3108934|Superiority or Other||Adjusted mean difference|0.66||||0.8767||95.0|-7.75|9.08||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution|Null hypothesis is no difference between treatments.|
1690992|NCT01115452|3108934|Superiority or Other||Adjusted mean difference|-1.35||||0.7472|2-Sided|95.0|-9.62|6.92||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690993|NCT01115452|3108935|Superiority or Other||Adjusted mean difference|-5.49||||0.1957||95.0|-13.83|2.85||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690994|NCT01115452|3108935|Superiority or Other||Adjusted mean difference|-1.27||||0.7646|2-Sided|95.0|-9.62|7.08||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690995|NCT01115452|3108935|Superiority or Other||Adjusted mean difference|4.22||||0.3122|2-Sided|95.0|-4.0|12.44|||ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1691025|NCT01114737|3109006|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.2||0.51|2-Sided|95.0|-0.2|0.5|||ANCOVA|Adjusted for Week 13 Global Impression-Severity Score, ADHD symptom, and ADHD medication.|||
1691222|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Irregular Heart Beat at week 12|
1690996|NCT01115452|3108936|Superiority or Other||Adjusted mean difference|0.01||||0.9978|2-Sided|95.0|-8.33|8.35||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690997|NCT01115452|3108936|Superiority or Other||Adjusted mean difference|-0.9||||0.8314|2-Sided|95.0|-9.25|7.45||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690998|NCT01115452|3108936|Superiority or Other||Adjusted mean difference|-0.91||||0.8265|2-Sided|95.0|-9.13|7.3||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1690999|NCT01115452|3108937|Superiority or Other||Adjusted mean difference|3.88||||0.36|2-Sided|95.0|-4.46|12.22||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 2.5% potassium nitrate solution minus water. Negative difference favored 2.5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1691000|NCT01115452|3108937|Superiority or Other||Adjusted mean difference|3.9||||0.3582|2-Sided|95.0|-4.45|12.25||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus water. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1691001|NCT01115452|3108937|Superiority or Other||Adjusted mean difference|0.02||||0.9963|2-Sided|95.0|-8.2|8.24||Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|ANCOVA|No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis is no difference between treatments.|
1691002|NCT01115452|3108938|Superiority or Other||Adjusted mean difference|-0.32||||0.9347|2-Sided|95.0|-8.14|7.5||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANCOVA|Treatment group, treatment application site and assessment time were fixed factors, baseline VAS was a covariate and participant was a random factor.|Difference was calculated as adjusted mean change from baseline in 5% potassium nitrate solution minus 2.5% potassium nitrate solution. Negative difference favored 5% potassium nitrate solution.|Null hypothesis was no difference between treatments.|
1691003|NCT01115231|3108943|Other|multivariable logistic regression model|Odds Ratio (OR)|2.03|||||2-Sided|95.0|0.93|4.42|||||||
1691004|NCT01115101|3108953|Non-Inferiority or Equivalence|VAS score at 24h were defined as primary endpoint because of the expectation of the maximal effect at this time. Testing for differences of continuous variables between the study groups at baseline was accomplished by the 2-sample t test for independent samples or the Mann-Whitney U test, as appropriate.|Mean Difference (Net)|0.05|Standard Error of the Mean|0.05|<|0.05||95.0|||||Chi-squared|Test selection was based on evaluating the variables for normal distribution employing the Kolmogorov-Smirnov test.||"The sample size of n=120 was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05.~Because measurements were made several times on the same patients within in two independent groups, GLM Repeated Measurement procedure was applied to test null hypotheses about the effects of both the between-subject factor (study group) and the within-subject factor (time)."|
1691005|NCT01114880|3108974|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1691006|NCT01114880|3108976|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1691007|NCT01114880|3108978|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1691008|NCT01114880|3108980|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1691009|NCT01114880|3108982|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1691010|NCT01114880|3108984|Superiority or Other||||||<|0.001|||||||Chi-squared, Corrected||||
1691011|NCT01114880|3108986|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1691012|NCT01114880|3108988|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1691013|NCT01114880|3108990|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1691014|NCT01114880|3108992|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1691015|NCT01114880|3108994|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1691016|NCT01114737|3108997|Superiority or Other||Mean Difference (Final Values)|-2.2|Standard Error of the Mean|2.0||0.279|2-Sided|95.0|-6.3|1.8|||ANCOVA|Adjusted for Baseline BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.|||
1691017|NCT01114737|3108998|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|2.8||0.833|2-Sided|95.0|-6.2|5.0|||ANCOVA|Adjusted for Baseline BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.|||
1691018|NCT01114737|3108999|Superiority or Other||Relative Risk|0.87||||0.67|2-Sided|95.0|0.46|1.64|||Cochran-Mantel-Haenszel|Adjusted for age group, ADHD symptom, and ADHD medication|||
1691019|NCT01114737|3109000|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.2||0.564|2-Sided|95.0|-0.2|0.4|||ANCOVA|Adjusted for Baseline Clinical Global Impression-Severity (CGI-S), ADHD symptom, and ADHD medication.|||
1691026|NCT01114737|3109007|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.8||0.636|2-Sided|95.0|-1.2|1.9|||ANCOVA|Adjusted for Week 13 HAMD Rating Scale Total Score, age group, ADHD symptom, and ADHD|||
1691027|NCT01114737|3109008|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|1.0||0.59|2-Sided|95.0|-2.4|1.4|||ANCOVA|Adjusted for Week 13 HAMA Anxiety Rating Scale Total Score, age group, ADHD symptom, and ADHD medication.|||
1691028|NCT01114737|3109009|Superiority or Other||Mean Difference (Final Values)|2.6|Standard Error of the Mean|2.6||0.312|2-Sided|95.0|-2.6|7.8|||ANCOVA|Adjusted for Week 13 ADHD RS/ASRS Total Score, age group, and ADHD medication.|||
1691029|NCT01114737|3109010|Superiority or Other||Mean Difference (Final Values)|-4.1|Standard Error of the Mean|1.9||0.034|2-Sided|95.0|-7.9|-0.3|||ANCOVA|Adjusted for Baseline BRIEF Parent-GEC T Score, ADHD symptom, and ADHD medication.|||
1691030|NCT01114737|3109011|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|2.2||0.661|2-Sided|95.0|-5.5|3.6|||ANCOVA|Adjusted for Baseline BRIEF Adult-GEC T Score, ADHD symptom, and ADHD medication.|||
1691031|NCT01114737|3109012|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.2||0.531|2-Sided|95.0|-0.4|0.2|||ANCOVA|Adjusted for baseline CGI-Severity Response, age group, ADHD symptom, and ADHD medication.|||
1691032|NCT01114737|3109013|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.8||0.588|2-Sided|95.0|-1.1|1.9|||ANCOVA|Adjusted for Baseline HAM-D Rating Scale Total Score, age group, ADHD symptom, and ADHD medication.|||
1691033|NCT01114737|3109014|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.9||0.669|2-Sided|95.0|-1.5|2.3|||ANCOVA|Adjusted for baseline HAMA Anxiety Scale Total Score, age group, ADHD symptom, and ADHD medication.|||
1691034|NCT01114737|3109015|Superiority or Other||Mean Difference (Final Values)|-4.2|Standard Error of the Mean|2.3||0.085|2-Sided|95.0|-8.9|0.6|||ANCOVA|Adjusted for baseline ADHD-RS/ASRS total score, age group, and ADHD medication.|||
1691035|NCT01114516|3109078|Superiority or Other|||||||0.393|||||||Kruskal-Wallis||||
1691036|NCT01114516|3109079|Superiority or Other||Risk Ratio (RR)|1.48|||||2-Sided|95.0|1.06|2.05|||||||
1691037|NCT01114516|3109080|Superiority or Other|||||||0.018|||||||Log Rank|||Kaplan Meier survival analysis|
1691038|NCT01114373|3109103|Superiority or Other|||||||0.39|||||||ANOVA||||
1691039|NCT01114373|3109104|Superiority or Other|||||||0.58|||||||ANOVA||||
1691040|NCT01114373|3109105|Superiority or Other|||||||0.13|||||||ANOVA||||
1691041|NCT01114373|3109106|Superiority or Other|||||||0.41|||||||Friedman||||
1691042|NCT01114373|3109107|Superiority or Other|||||||0.21|||||||Friedman||||
1691043|NCT01114373|3109108|Superiority or Other|||||||0.06|||||||Friedman||||
1691044|NCT01114373|3109109|Superiority or Other|||||||0.21|||||||ANOVA||||
1691045|NCT01114373|3109110|Superiority or Other|||||||0.12|||||||ANOVA||||
1691046|NCT01114373|3109111|Superiority or Other|||||||0.12|||||||ANOVA||||
1691047|NCT01114373|3109112|Superiority or Other|||||||0.16|||||||ANOVA||||
1691048|NCT01114373|3109113|Superiority or Other|||||||0.88|||||||ANOVA||||
1691049|NCT01114373|3109114|Superiority or Other|||||||0.91|||||||ANOVA||||
1691050|NCT01114373|3109115|Superiority or Other|||||||0.95|||||||ANOVA||||
1691051|NCT01114373|3109115|Superiority or Other|||||||0.0492|||||||ANOVA|||The null hypothesis was that there is no interaction between the order of randomization and the primary outcome measures.|
1691052|NCT01114373|3109116|Superiority or Other|||||||0.84|||||||ANOVA||||
1691053|NCT01114373|3109116|Superiority or Other|||||||0.0269|||||||ANOVA|||The null hypothesis was that there is no interaction between the order of randomization and the primary outcome measures.|
1691054|NCT01114360|3109119|Superiority or Other|||||||0.52|||||||ANOVA||||
1691055|NCT01114360|3109120|Superiority or Other|||||||0.25|||||||ANOVA||||
1691056|NCT01114360|3109121|Superiority or Other|||||||0.96|||||||ANOVA||||
1691057|NCT01114360|3109122|Superiority or Other|||||||0.11|||||||Friedman||||
1691058|NCT01114360|3109123|Superiority or Other|||||||0.38|||||||Friedman||||
1691059|NCT01114360|3109124|Superiority or Other|||||||0.71|||||||Friedman||||
1691060|NCT01114360|3109125|Superiority or Other|||||||0.75|||||||ANOVA|||The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.|
1691061|NCT01114360|3109126|Superiority or Other|||||||0.01|||||||ANOVA||||
1691062|NCT01114360|3109127|Superiority or Other|||||||0.97|||||||ANOVA||||
1691063|NCT01114360|3109128|Superiority or Other|||||||0.89|||||||ANOVA||||
1691064|NCT01114360|3109129|Superiority or Other|||||||0.64|||||||ANOVA||||
1691065|NCT01114360|3109130|Superiority or Other|||||||0.21|||||||ANOVA||||
1691066|NCT01114360|3109131|Superiority or Other|||||||0.79|||||||ANOVA||||
1691067|NCT01114360|3109132|Superiority or Other|||||||0.75|||||||ANOVA||||
1691068|NCT01114360|3109132|Superiority or Other|||||||0.075|||||||ANOVA|Two-way repeated measures mixed model ANOVA.||The null hypothesis is that there is no interaction between the order of randomization and primary outcomes.|
1691069|NCT01114217|3109142|Other||||||<|0.0001|||||||t-test, 2 sided||||
1691070|NCT01114204|3109148|Non-Inferiority|The 95% confidence interval (CI) was calculated using the large sample assumption. The pre-defined non-inferiority margin for testing the difference between treatment groups was -15%.|Treatment Difference|2.58||||0.2833|2-Sided|95.0|-3.89|9.06|||Cochran-Mantel-Haenszel|The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.|The treatment difference (ferumoxytol - iron sucrose) was expressed as a percentage.|"Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. Statistical comparison was performed for data up to Week 5 only.~Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information."|
1691102|NCT01112735|3109259|Superiority|||||||0.9699|||||||Wilcoxon (Mann-Whitney)|||Day 3|
1691103|NCT01112735|3109260|Superiority|||||||0.3837|||||||Wilcoxon (Mann-Whitney)|||Day 90|
1691071|NCT01114139|3109154|Superiority|The 95% confidence interval was calculated using the large sample assumption.|Treatment Difference|75.59|||<|0.0001|2-Sided|95.0|71.15|80.02|||Cochran-Mantel-Haenszel|The p-value is the result of the Cochran-Mantel-Haenszel test, adjusted for Baseline hemoglobin level and underlying condition.|The treatment difference (ferumoxytol - placebo) was expressed as a percentage.|Participants who achieved a ≥2.0 g/dL increase in hemoglobin from Baseline up to Week 5 were analyzed. Statistical comparison was performed for data up to Week 5 only. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.|
1691072|NCT01113931|3109157|Superiority or Other||Difference in Percent Cure Rates|0.2|||||2-Sided|95.0|-4.6|5.1||||||The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.|
1691073|NCT01113931|3109160|Superiority or Other||Difference in Percent Cure Rates|0.3|||||2-Sided|95.0|-4.6|5.1||||||The planned sample size of 480 randomized subjects ensured that approximately 200 subjects per group were included in the primary efficacy analyses. The 20% rate of exclusion was to account for subjects who had a negative test for urogenital C. trachomatis at the Baseline visit.|
1691074|NCT01113892|3109161|Other|||||||0.68|||||||Chi-squared|Proportion of subjects who achieve secondary patency for both treatment groups will be compared using a Chi Square test|||
1691075|NCT01113892|3109163|Other|||||||0.181|||||||Chi-squared|Proportion of subjects who achieve primary assisted patency for both treatment groups will be compared using a Chi-Square test|||
1691076|NCT01113892|3109165|Non-Inferiority|"Repeated 6 month analyses for 12 month results.The non-inferiority margin was 15%. The following null hypothesis (H0) and alternative hypothesis (HA) were tested, with the primary patency rate for FUSION Bioline (PF), and the primary patency rate for EXXCEL (PE).~H0: PF - PE < - 0.15; HA: PF - PE > - 0.15 An exact 1-sided test was used for the observed difference of patency rates between the FUSION Bioline (test) and EXXCEL (control) products, with a p-value ≤ .05 indicating significance."|Mean Difference (Net)|9.5||||0.0001|2-Sided|95.0|-4.8|23.0|||Exact 1-sided test||||
1691077|NCT01113892|3109167|Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Difference between groups were compared with the Wilcoxon Rank Sum Test|
1691078|NCT01113892|3109168|Other|||||||0.137|||||||Chi-squared|Proportion of subjects who achieve secondary patency for both treatment groups will be compared using a Chi-Square test|||
1691079|NCT01113892|3109169|Other|||||||0.017|||||||Chi-squared|Proportion of subjects who achieved primary assisted patency for both treatment groups were compared using a Chi-Square test|||
1691080|NCT01113892|3109170|Equivalence|Fisher’s Exact test was used to evaluate whether subjects with any MALE event or POD were homogeneous across the treatment arms.||||||0.033|||||||Fisher Exact|||The number and percentage of subjects with a MALE or POD event were summarized by treatment group.|
1691081|NCT01113892|3109171|Non-Inferiority|"The non-inferiority margin was 15%. The following null hypothesis (H0) and alternative hypothesis (HA) were tested, with the primary patency rate at 6 months for FUSION Bioline (PF), and the primary patency rate at 6 months for EXXCEL (PE).~H0: PF - PE < - 0.15; HA: PF - PE > - 0.15 An exact 1-sided test was used for the observed difference of patency rates between the FUSION Bioline (test) and EXXCEL (control) products."|Mean Difference (Net)|16.4|||<|0.0001|2-Sided|95.0|2.7|29.9||The threshold for significance was p = .05|Exact 1-sided test||Difference = Patency (Fusion Bioline) - Patency (EXXCEL)|It was calculated that 200 participants randomized in a 1:1 fashion would have at least 80% power to detect a difference of 15% in the number of participants with primary patency between FUSION Bioline and EXXCEL groups at 6 months. It was assumed that the ratio of Above-Knee to Below-Knee procedures was 60:40; based on this, the primary patency rate for the combined Above-Knee and Below-Knee patients was 79%. Assumptions included a 10% withdrawal rate prior to the 6-month evaluation.|
1691082|NCT01113879|3109173|Other||||||<|0.001|||||||Weighted Tau U|||Weighted Tau U effect size mean values in Block 1 of treatment (no aerobic exercise or stretching) were compared to weighted Tau U mean values in Block 2 of treatment (aerobic exercise or stretching adjuvant).|
1691083|NCT01113385|3109238|Superiority or Other|||||||0.009||||||p value reflects the difference in mean FSPF pre vs post galactose treatment.|t-test, 2 sided||||
1691084|NCT01112982|3109242|Other|||||||0.99||||||"The Severity of Synovial Pannus in the index joint."|t-test, 1 sided||||
1691085|NCT01112982|3109242|Other|||||||0.32||||||"The Presence of synovial Pannus in the index joint."|t-test, 1 sided||||
1691086|NCT01112982|3109243|Other|The absence of Soft Tissue Edema.||||||0.14|||||||t-test, 2 sided||||
1691087|NCT01112982|3109243|Other|The absence of Bone Marrow Edema.||||||0.25|||||||t-test, 2 sided||||
1691088|NCT01112982|3109243|Other|The absence of Joint Effusion.||||||0.31|||||||t-test, 2 sided||||
1691089|NCT01112982|3109243|Other|The absence of Soft Tissue Tophi||||||0.09|||||||t-test, 2 sided||||
1691090|NCT01112982|3109243|Other|the absence of Intraosseous Tophi.||||||0.33|||||||t-test, 2 sided||||
1691091|NCT01112982|3109243|Other|Kappa Coefficient||||||0.09|||||||t-test, 2 sided|||The absence of erosive changes.|
1691092|NCT01112982|3109244|Other|||||||0.32||||||The presence of synovial pannus in the “index joint”.|t-test, 1 sided||||
1691093|NCT01112982|3109245|Other|correlation between severity of synovial pannus and the serum urate level.||||||0.73|||||||t-test, 1 sided||||
1691094|NCT01112982|3109246|Other|Spearman Correlation Coefficient||||||0.73|||||||t-test, 1 sided|||The Severity of Synovial Pannus and the Serum Urate level.|
1691095|NCT01112982|3109248|Other|||||||0.34|||||||t-test, 2 sided|||Presence of synovial pannus and the serum urate level.|
1691096|NCT01112865|3109252|Superiority or Other|||||||0.6858||||||Binomial test against the null hypothesis|binomial test|||Null hypothesis: percentage of participants preferring Genotropin Mark VII injection pen = 50%|
1691097|NCT01112735|3109259|Superiority|||||||0.7564|||||||Wilcoxon (Mann-Whitney)|||Day 90|
1691098|NCT01112735|3109259|Superiority|||||||0.2704|||||||Wilcoxon (Mann-Whitney)|||Day 60|
1691099|NCT01112735|3109259|Superiority|||||||0.4291|||||||Wilcoxon (Mann-Whitney)|||Day 28|
1691100|NCT01112735|3109259|Superiority|||||||0.1406|||||||Wilcoxon (Mann-Whitney)|||Day 14|
1691101|NCT01112735|3109259|Superiority|||||||0.4709|||||||Wilcoxon (Mann-Whitney)|||Day 7|
1691111|NCT01112683|3109270|Superiority or Other|||||||0.371||||||This P-Value refers to the SIB-R Broad independence score.|Mixed Models Analysis|An alpha level of 0.05 or lower represents statistical significance, no correction was made for multiple comparisons to minimize type II errors.||No power calculations were performed for the secondary measures.|
1691112|NCT01112683|3109271|Superiority or Other|||||||0.403|||||||Mixed Models Analysis|An alpha level of 0.05 or lower represents statistical significance, no correction was made for multiple comparisons to minimize type II errors.||20 subjects per group were expected to provide 60% power to detect a between-group mean difference of 1.2 correct patterns (change from baseline to week 16) on the Paired Associates Learning and to provide 40% power to detect a between-group mean difference of 1.2 patterns recognized on the Pattern Recognition Memory. A two-sided test at type I error rate of 5% was used. Sample size incorporated an inflation factor of 20% to account for ineligibility of 10% of randomized participants.|
1691113|NCT01112670|3109272|Superiority or Other|||||||0.43|||||||ANOVA||||
1691114|NCT01112670|3109273|Superiority or Other|||||||0.29|||||||ANOVA||||
1691115|NCT01112670|3109274|Superiority or Other|||||||0.14|||||||ANOVA||||
1691116|NCT01112670|3109275|Superiority or Other|||||||0.22|||||||ANOVA||||
1691117|NCT01112670|3109276|Superiority or Other|||||||0.21|||||||ANOVA||||
1691118|NCT01112670|3109277|Superiority or Other|||||||0.86|||||||ANOVA||||
1691119|NCT01112670|3109278|Superiority or Other|||||||0.97|||||||ANOVA||||
1691120|NCT01112670|3109279|Superiority or Other|||||||0.56|||||||ANOVA||||
1691121|NCT01112670|3109280|Superiority or Other|||||||0.9|||||||ANOVA||||
1691122|NCT01112670|3109281|Superiority or Other|||||||0.67|||||||ANOVA||||
1691123|NCT01112670|3109282|Superiority or Other|||||||0.83|||||||ANOVA||||
1691124|NCT01112579|3109283|Superiority or Other||Mean Difference (Final Values)|0.8||||0.93|2-Sided|95.0|-1.6|3.2|||ANCOVA||||
1691125|NCT01112579|3109284|Superiority or Other||Mean Difference (Final Values)|-106.1||||0.79|2-Sided|95.0|-845.8|633.6|||ANCOVA||||
1691126|NCT01112579|3109285|Superiority or Other||Mean Difference (Final Values)|6.4||||0.3|2-Sided|95.0|-2.0|14.9|||ANCOVA||||
1691127|NCT01112267|3109311|Superiority or Other|||||||0.5632||||||p-value for participant's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Chi-squared||||
1691128|NCT01112267|3109312|Superiority or Other|||||||0.0917||||||p-value for investigator's global assessment on investigational product at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Chi-squared||||
1691129|NCT01112267|3109313|Superiority or Other|||||||0.0527||||||p-value for change from Baseline in ODI- Korean version at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)||||
1691130|NCT01112267|3109314|Superiority or Other|||||||0.0047||||||p-value for change from Baseline in Reptd. health transition at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)||||
1691131|NCT01112267|3109314|Superiority or Other|||||||0.7776||||||p-value for change from Baseline in mental health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)||||
1691132|NCT01112267|3109314|Superiority or Other|||||||0.7788||||||p-value for change from Baseline in role emotional at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)||||
1691133|NCT01112267|3109314|Superiority or Other|||||||0.115||||||p-value for change from Baseline in social functioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)||||
1691134|NCT01112267|3109314|Superiority or Other|||||||0.0524||||||p-value for change from Baseline in vitality at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)||||
1691135|NCT01112267|3109314|Superiority or Other|||||||0.0395||||||p-value for change from Baseline in general health at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)||||
1691136|NCT01112267|3109314|Superiority or Other|||||||0.5712||||||p-value for change from Baseline in bodily pain at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)||||
1691137|NCT01112267|3109314|Superiority or Other|||||||0.0224||||||p-value for change from Baseline in role physical at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups.|Wilcoxon (Mann-Whitney)||||
1691138|NCT01112267|3109314|Superiority or Other|||||||0.3524||||||p-value for change from Baseline in physical conditioning at Day 29 was calculated using for tramadol HCl/acetaminophen and placebo groups|Wilcoxon (Mann-Whitney)||||
1691139|NCT01112267|3109315|Superiority or Other|||||||0.4652||||||p-value for percentage of participants with pain relief at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared||||
1691140|NCT01112267|3109315|Superiority or Other|||||||0.0102||||||p-value for percentage of participants with pain relief at Day 15 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared||||
1691141|NCT01112267|3109315|Superiority or Other|||||||0.0202||||||p-value for percentage of participants with pain relief at Day 8 was calculated for tramadol HCl/acetaminophen and placebo groups|Chi-squared||||
1691142|NCT01112267|3109316|Superiority or Other|||||||0.0095||||||p-value for change in reduction in pain intensity at Day 29 was calculated for tramadol HCl/acetaminophen and placebo groups|Mann-Whitney U test||||
1691143|NCT01112267|3109317|Superiority or Other|||||||0.0367|||||||Cochran-Mantel-Haenszel|p-value for percentage of participants with reduction in pain intensity was calculated for tramadol HCl/acetaminophen and placebo groups|||
1691144|NCT01112059|3109330|Superiority or Other||Hazard Ratio (HR)|0.5|||<|0.05|2-Sided|95.0|0.128|0.633|||Wilcoxon (Mann-Whitney)||||
1691145|NCT01111851|3109332|Superiority or Other||Geometric Mean Ratio of the LS means|0.91|||||2-Sided|90.0|0.5|1.66|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) [aprepitant~165 mg/fosaprepitant 150 mg]."||
1691146|NCT01111851|3109333|Superiority or Other||Geometric Mean Ratio of the LS means|1.0|||||2-Sided|90.0|0.97|1.03|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) [aprepitant~165 mg/fosaprepitant 150 mg]."||
1696408|NCT01033942|3118849|Superiority or Other|||||||0.5645|||||||Fisher Exact||||
1691147|NCT01111851|3109334|Superiority or Other||Geometric Mean Ratio of the LS means|1.0|||||2-Sided|90.0|0.98|1.02|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) [aprepitant~165 mg/fosaprepitant 150 mg]."||
1691148|NCT01111851|3109335|Superiority or Other||Geometric Mean Ratio of the LS Means|1.0|||||2-Sided|90.0|0.99|1.01|||||"The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) [aprepitant~165 mg/fosaprepitant 150 mg]."||
1691149|NCT01111331|3109378|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.85|||||2-Sided|95.0|0.47|1.51||||||Difference calculated as empa plus warfarin minus warfarin|
1691150|NCT01111331|3109379|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.97|||||2-Sided|95.0|0.68|1.4||||||Difference calculated as empa plus warfarin minus warfarin|
1691151|NCT01111331|3109380|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.91|||||2-Sided|95.0|0.84|0.98||||||Difference calculated as empa plus warfarin minus warfarin|
1691152|NCT01111331|3109381|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|1.12|||||2-Sided|95.0|0.64|1.95||||||Difference calculated as empa plus warfarin minus warfarin|
1691153|NCT01111331|3109382|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.9|||||2-Sided|95.0|0.79|1.02||||||Difference calculated as empa plus warfarin minus warfarin|
1691154|NCT01111331|3109383|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.99|||||2-Sided|95.0|0.67|1.48||||||Difference calculated as empa plus warfarin minus warfarin|
1691155|NCT01111331|3109384|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.88|||||2-Sided|95.0|0.79|0.98||||||Difference calculated as empa plus warfarin minus warfarin|
1691156|NCT01111331|3109385|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric mean ratio|0.87|||||2-Sided|95.0|0.73|1.04||||||Difference calculated as empa plus warfarin minus warfarin|
1691157|NCT01111331|3109392|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|96.09|Standard Deviation|4.4|||2-Sided|90.0|93.64|98.6|||||Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin|
1691158|NCT01111331|3109399|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.9|Standard Deviation|5.3|||2-Sided|90.0|95.89|102.0|||||Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin|
1691159|NCT01111331|3109407|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.88|Standard Deviation|12.7||0.0001|2-Sided|90.0|91.84|106.47||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin|
1691160|NCT01111331|3109408|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|95.88|Standard Deviation|4.5|||2-Sided|90.0|93.4|98.43|||||Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by warfarin|
1691161|NCT01111331|3109409|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|97.89|Standard Deviation|12.4||0.0001|2-Sided|90.0|91.12|105.15|||ANOVA|Based on ANOVA with terms for sequence, subjects within sequence, period and treatment|Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin|
1691162|NCT01111331|3109410|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|98.49|Standard Deviation|5.7|||2-Sided|90.0|95.29|101.8|||||Standard deviation is actually the geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by warfarin|
1691163|NCT01111331|3109411|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric Mean Ratio|100.64|Standard Deviation|19.9||0.0021|2-Sided|90.0|89.79|112.8||p-value for geometric mean ratio being outside interval 80% to 125%|ANOVA|Based on ANOVA with terms for subject and treatment|Standard deviation is actually the intra-individual gCV|Ratio calculated as empa plus warfarin divided by empa|
1691164|NCT01111331|3109412|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability.|Geometric Mean ratio|100.89|Standard Deviation|7.0|||2-Sided|90.0|96.86|105.1|||||Standard deviation is actually the intra-individual geometric coefficient of variation (gCV)|Ratio calculated as empa plus warfarin divided by empa|
1691165|NCT01111318|3109425|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio|148.41|Standard Deviation|30.7|||2-Sided|90.0|117.65|187.23|||||Standard deviation is actually the geometric coefficient of variation|Ratio calculated as severe divided by healthy|
1691166|NCT01111318|3109425|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio|123.31|Standard Deviation|30.7|||2-Sided|90.0|97.74|155.55|||||Standard deviation is actually the geometric coefficient of variation|Ratio calculated as moderate divided by healthy|
1691167|NCT01111318|3109425|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio|103.81|Standard Deviation|30.7|||2-Sided|90.0|82.29|130.95|||||Standard deviation is actually the geometric coefficient of variation|Ratio calculated as mild divided by healthy|
1691168|NCT01111318|3109426|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio|174.7|Standard Deviation|29.0|||2-Sided|90.0|140.29|217.55|||||Standard deviation is actually the geometric coefficient of variation|Ratio calculated as severe divided by healthy|
1691169|NCT01111318|3109426|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio|146.97|Standard Deviation|29.0|||2-Sided|90.0|118.02|183.02|||||Standard deviation is actually the geometric coefficient of variation|Ratio calculated as moderate divided by healthy|
1691223|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Chest Pain at Week 12|
1696409|NCT01033942|3118850|Superiority or Other|||||||0.0544|||||||Fisher Exact||||
1691170|NCT01111318|3109426|Non-Inferiority or Equivalence|No formal testing, investigation of relative bioavailability|Geometric mean ratio|123.15|Standard Deviation|29.0|||2-Sided|90.0|98.89|153.36|||||Standard deviation is actually the geometric coefficient of variation|Ratio calculated as mild divided by healthy|
1691171|NCT01111305|3109430|Equivalence|Equivalence is defined as p≥0.05||||||0.028|||||||Wilcoxon (Mann-Whitney)||||
1691172|NCT01111149|3109453|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical Analysis for AIMS Global Score (Week 12)|
1691173|NCT01111149|3109453|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for AIMS Severity Index (Week 12)|
1691174|NCT01111149|3109453|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for AIMS Total (Week 12)|
1691175|NCT01111149|3109454|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS % Strong Urge (Week 12)|
1691176|NCT01111149|3109454|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS % Urge to Smoke (Week 12)|
1691177|NCT01111149|3109455|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for WISDM Craving (Week 12)|
1691178|NCT01111149|3109455|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical Analysis for WISDM Cognition (Week 12)|
1691179|NCT01111149|3109455|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for WISDM Total (Week 12)|
1691180|NCT01111149|3109456|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for Response Style Indicator (Beta) for CPT (week 12)|
1691181|NCT01111149|3109457|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for Detectibility (d') of Continuous Performance Test (Week 12)|
1691182|NCT01111149|3109458|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for Variability of Standard Error - CPT (Week 12)|
1691183|NCT01111149|3109459|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for Hit Reaction Time - CPT (Week 12)|
1691184|NCT01111149|3109460|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Depression Subscale - Week 12|
1691185|NCT01111149|3109460|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for Disorientation Subscale - Week 12|
1691186|NCT01111149|3109460|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for Mania Subscale - Week 12|
1691187|NCT01111149|3109460|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Negative Subscale - Week 12|
1691188|NCT01111149|3109460|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Positive Subscale - Week 12|
1691189|NCT01111149|3109460|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for BPRS Total - Week 12|
1691190|NCT01111149|3109461|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Thought Disorder - Week 12|
1691191|NCT01111149|3109461|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical Analysis for SAPS Bizarre Behavior - Week 12|
1691192|NCT01111149|3109461|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for Delusions - Week 12|
1691193|NCT01111149|3109461|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Hallucinations - Week 12|
1691194|NCT01111149|3109461|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Total Global - Week 12|
1691195|NCT01111149|3109461|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for SAPS Total Composite Score - Week 12|
1691196|NCT01111149|3109462|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for Lifetime Suicide Attempts (Week 12)|
1691197|NCT01111149|3109462|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for Lifetime Suicidal Ideation (Week 12)|
1691198|NCT01111149|3109463|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for Vital Signs - Pulse (Week 12)|
1691199|NCT01111149|3109464|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)|
1691200|NCT01111149|3109465|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for Smoking Abstinence - Number of Cigarettes Smoked (Week 12)|
1691201|NCT01111149|3109466|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for Vital Signs - Weight (Week 12)|
1691202|NCT01111149|3109467|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for diastolic blood pressure (Week 12)|
1691203|NCT01111149|3109467|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for systolic blood pressure (Week 12)|
1691204|NCT01111149|3109468|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for BAS item 4 (Week 12)|
1691205|NCT01111149|3109468|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for BAS items 1-3 (week 12)|
1691206|NCT01111149|3109468|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for SAS (Week 12)|
1691207|NCT01111149|3109469|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis of Beck Depression Inventory (Week 12)|
1691208|NCT01111149|3109470|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS Resistance (Week 12)|
1691209|NCT01111149|3109470|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS 7 day total (Week 12)|
1691210|NCT01111149|3109470|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for MNWS 24 Hour Total (Week 12)|
1691211|NCT01111149|3109470|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for FTND (Week 12)|
1691212|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Leg Pain/Cramps|
1691213|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Blurred Vision at week 12|
1691214|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Cold Sweats at week 12|
1691215|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for drooling at week 12|
1691216|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Irritability at week 12|
1691217|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Confusion at week 12|
1691224|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Dry Mouth at week 12|
1691225|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Psychosis at week 12|
1691226|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Nausea at week 12|
1691227|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Insomnia at week 12|
1691228|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Headache at week 12|
1691229|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Abdominal Pain at week 12|
1691230|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for abnormal dreams at week 12|
1691231|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Mania at week 12|
1691232|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Dizziness at week 12|
1691233|NCT01111149|3109471|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Statistical analysis for Anxiety at week 12|
1691234|NCT01111149|3109472|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for perseveration % (week 12)|
1691235|NCT01111149|3109472|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for CPT% commissions (Week 12)|
1691236|NCT01111149|3109472|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for CPT % Omissions (Week 12)|
1691237|NCT01111149|3109473|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis of Inappropriate Affect at Week 12|
1691238|NCT01111149|3109473|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Attention (Week 12)|
1691239|NCT01111149|3109473|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Anhedonia (Week 12)|
1691240|NCT01111149|3109473|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Avolition (Week 12)|
1691241|NCT01111149|3109473|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Alogia (Week 12)|
1691242|NCT01111149|3109473|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Affective Flattening (Week 12)|
1691243|NCT01111149|3109473|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Total Global (Week 12)|
1691244|NCT01111149|3109473|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical analysis for SANS Total Composite (Week 12)|
1691245|NCT01111149|3109474|Superiority or Other||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Urine Cotinine (Week 12)|
1691246|NCT01111149|3109474|Superiority or Other||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Serum Cotinine (Week 12)|
1691247|NCT01111149|3109474|Superiority or Other||||||>|0.05|||||||Chi-squared|||Statistical Analysis for 30% Reduction in Carbon Monoxide (Week 12)|
1691248|NCT01111149|3109474|Superiority or Other||||||>|0.05|||||||Chi-squared|||Statistical analysis for 50% Reduction in Number of Cigarettes Smoked (Week 12)|
1691249|NCT01111149|3109475|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical Analysis for Urine Nicotine at Week 12|
1691250|NCT01111149|3109475|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical Analysis for Urine Cotinine at Week 12|
1691251|NCT01111149|3109475|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical Analysis for Serum Nicotine at Week 12|
1691252|NCT01111149|3109475|Superiority or Other||||||>|0.05|||||||ANOVA|||Statistical Analysis for Serum Cotinine at Week 12|
1691253|NCT01111123|3109476|Superiority or Other||||||<|0.05|||||||ANCOVA|||Secondary outcomes, including subject self-assessment and signs of psoriasis ratings, were analyzed as continuous dependent variables in these statistical models. Mixed modeling analysis of covariance (ANCOVA) was used to compare the relationships between psoriasis symptoms over time in the placebo and steroid treatment groups|
1691254|NCT01111123|3109477|Superiority or Other||||||<|0.05||||||CI of 95%|Log Rank|||Probabilities of PGA not worsening were estimated using the Kaplan-Meier product limit method with a comparison between treatment group survival curves evaluated by the log-rank test statistic. The Cox proportional hazards model was used to estimate the hazard ratio for worsening of PGA (equivalent to a relative risk adjusted for follow-up time) and a corresponding 95-percent confidence interval.|
1691255|NCT01111110|3109478|Superiority or Other||Effect size=half the mean diff|24.7|Standard Error of the Mean|6.6||0.013|2-Sided|95.0|7.7|41.7|||t-test, 2 sided||You kicked this out on another trial, but note that the period 2-Period 1 differences between the orderings estimate twice the effect size. The effect sizes herein take this into account.|Null hypothesis is that the Treatment order is independent of the dependent variable based on Period 2 minus Period 1|
1691256|NCT01111110|3109479|Superiority or Other||half the mean difference|23.5|Standard Error of the Mean|6.8||0.018|2-Sided|95.0|6.0|41.0||The effect size is half the difference between the means as (A-B)-(B-A)=2A-2B|t-test, 2 sided|Must take half the mean difference to estimate effect size|No comments|Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.|
1691257|NCT01111110|3109480|Superiority or Other||half the mean difference|21.0|Standard Error of the Mean|6.7||0.026|2-Sided|95.0|3.8|41.7|||t-test, 2 sided|two sample effect size must be halved to account for mean difference estimates twice the effect size|See 4 Puff result|(Comparison of period 2 minus period 1) results Point and interval estimates are halved because this estimates twice the effect size.|
1691258|NCT01111058|3109488|Superiority|||||||0.086|||||||Fisher Exact||||
1691259|NCT01111058|3109489|Superiority|||||||0.54|||||||Log Rank||||
1691260|NCT01111058|3109489|Superiority||Difference in survival proportions|0.0022||||0.9|2-Sided|95.0|-0.33|0.33|||Comparison of Kaplan-Meier estimates|Used Greenwood standard errors|||
1691261|NCT01110915|3109514|Superiority or Other||Complication rate at 4 months|7.7|||<|0.05|1-Sided|95.0||10.9||A priori threshold for statistical significance was 0.05.|Kaplan-Meier method|||Null hypothesis: the system-related complication rate between the implant procedure and the 4-months visit >= 20%.|
1691262|NCT01110915|3109515|Superiority or Other||Percentage|0.0|||<|0.0001|1-Sided|95.0||1.9||A priori threshold for statistical significance was 0.05.|exact test of binomial proportions|||Null hypothesis: the proportion of subjects with sustained ventricular arrhythmias and asystole during MRI scans >= 10%.|
1691263|NCT01110915|3109516|Non-Inferiority or Equivalence|The non-inferiority margin was 10%.|Difference in percentages|0.1||||0.0001|1-Sided|95.0|-4.6|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|
1691264|NCT01110915|3109517|Non-Inferiority or Equivalence|The non-inferiority margin was 10%.|Difference in percentages|1.5||||0.001|1-Sided|95.0|-6.1|||A priori threshold for statistical significance was 0.05.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group - 10%.|
1691265|NCT01110915|3109518|Non-Inferiority or Equivalence|The non-inferiority margin was 10%.|Difference in percentages|0.5|||<|0.0001|2-Sided|95.0|-5.0|5.9||A priori threshold for statistical significance was 0.025.|Farrington-Manning test|||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.|
1691266|NCT01110915|3109519|Non-Inferiority or Equivalence|The non-inferiority margin was 10%.|Difference in percentages|0.0||||||||||||||Null hypothesis: % successes MRI group ≤ % successes Control group -10%.|
1691267|NCT01110915|3109520|Superiority or Other||Percentage|0.0|||<|0.0001|1-Sided|97.5||2.5||A priori threshold for statistical significance was 0.025|exact test of binomial proportions|||Null Hypothesis: MRI-related complication rate between the MRI scan and one-month post-MRI >=10%.|
1691268|NCT01110200|3109569|Superiority or Other||Treatment comparison ratio|0.917||||0.71|2-Sided|95.0|0.581|1.447|||Negative bionomial regression model||Annualized rate estimates, the treatment comparison ratio, the confidence interval, and the p-value are from a negative binomial regression model with terms for treatment, country, randomization stratum, baseline severity, and time on treatment.||
1691269|NCT01110005|3109577|Superiority|||||||0.69|||||||Cochran-Mantel-Haenszel|This method was used to control for site of recruitment|||
1691270|NCT01110005|3109578|Superiority||Risk Ratio (RR)|1.1||||0.4|2-Sided|95.0|0.9|1.3|||Regression, log binomial|The regression model adjusted for site of recruitment as a covariate.|D5LR vs. LR||
1691271|NCT01110005|3109579|Superiority||Risk Ratio (RR)|1.3||||0.34|2-Sided|95.0|0.7|2.3|||Regression, log binomial|The regression model adjusted for site of recruitment as a covariate.|D5LR vs. LR||
1691272|NCT01109979|3109584|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)||||
1691273|NCT01109316|3109617|Superiority or Other|||||||0.051||||||P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.|Crossover Model||||
1691274|NCT01109316|3109617|Superiority or Other|||||||0.02||||||P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.|Crossover Model||||
1691275|NCT01109316|3109617|Superiority or Other|||||||0.805||||||P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.|Crossover Model||||
1691276|NCT01109316|3109617|Superiority or Other|||||||0.056||||||P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.|Crossover Model||||
1691277|NCT01109316|3109618|Superiority or Other|||||||0.486||||||P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.|Crossover Model||||
1691278|NCT01109316|3109618|Superiority or Other|||||||0.06||||||P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.|Crossover Model||||
1691279|NCT01109316|3109619|Superiority or Other|||||||0.002||||||P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test||||
1691280|NCT01109316|3109619|Superiority or Other|||||||0.006||||||P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test||||
1691281|NCT01109316|3109621|Superiority or Other||||||<|0.001||||||P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test||||
1691282|NCT01109316|3109621|Superiority or Other||||||<|0.737||||||P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test||||
1691283|NCT01109316|3109621|Superiority or Other||||||<|0.001||||||P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test||||
1691284|NCT01109316|3109621|Superiority or Other||||||<|0.471||||||P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.|Negative Binomial Test||||
1691285|NCT01109316|3109622|Superiority or Other|||||||0.017||||||P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test||||
1691286|NCT01109316|3109622|Superiority or Other|||||||1||||||P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test||||
1691287|NCT01109316|3109622|Superiority or Other|||||||0.006||||||P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test||||
1691288|NCT01109316|3109622|Superiority or Other|||||||0.736||||||P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test||||
1691289|NCT01109316|3109623|Superiority or Other|||||||0.185||||||P-value computed using a negative binomial test including factors for treatment, period, and sequence.|Negative Binomial Test||||
1691290|NCT01109316|3109623|Superiority or Other|||||||0.164||||||P-value computed using a negative binomial test including factors for treatment, period, and sequence.|Negative Binomial Test||||
1691291|NCT01109316|3109624|Superiority or Other|||||||1||||||P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.|Gart's Test||||
1691292|NCT01109316|3109625|Superiority or Other||Odds Ratio (OR)|1.04|||||2-Sided|95.0|0.66|1.64|||||Odds Ratio of HbA1c <7% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.||
1691293|NCT01109316|3109625|Superiority or Other||Odds Ratio (OR)|0.89|||||2-Sided|95.0|0.56|1.41|||||Odds Ratio of HbA1c <7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.||
1691294|NCT01109316|3109625|Superiority or Other||Odds Ratio (OR)|0.69|||||2-Sided|95.0|0.29|1.67|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.||
1691295|NCT01109316|3109625|Superiority or Other||Odds Ratio (OR)|0.93|||||2-Sided|95.0|0.5|1.75|||||Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.||
1691296|NCT01109316|3109626|Superiority or Other||Least Squares Mean Difference|0.09|||||2-Sided|95.0|0.01|0.18|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.||
1691297|NCT01109316|3109626|Superiority or Other||Least Squares Mean Difference|0.06|||||2-Sided|95.0|-0.02|0.14|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.||
1691298|NCT01109316|3109627|Superiority or Other||Least Squares Mean Difference|-0.1|||||2-Sided|95.0|-0.85|0.65|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.||
1691299|NCT01109316|3109627|Superiority or Other||Least Squares Mean Difference|0.06|||||2-Sided|95.0|-0.48|0.6|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.||
1691300|NCT01109316|3109627|Superiority or Other||Least Squares Mean Difference|-0.14|||||2-Sided|95.0|-0.56|0.27|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.||
1691301|NCT01109316|3109627|Superiority or Other||Least Squares Mean Difference|0.03|||||2-Sided|95.0|-0.18|0.24|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.||
1691302|NCT01109316|3109627|Superiority or Other||Least Squares Mean Difference|0.16|||||2-Sided|95.0|-0.41|0.73|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.||
1691303|NCT01109316|3109627|Superiority or Other||Least Squares Mean Difference|0.11|||||2-Sided|95.0|-0.29|0.51|||||Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.||
1691304|NCT01109316|3109628|Non-Inferiority or Equivalence|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.25|||||2-Sided|95.0|-0.05|0.56|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.||
1691305|NCT01109316|3109628|Non-Inferiority or Equivalence|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.22|||||2-Sided|95.0|-0.07|0.52|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.||
1691306|NCT01109316|3109629|Non-Inferiority or Equivalence|Non-inferiority margin of 0.6 mmol/L was used.|Least Squares Mean Difference|0.48|||||2-Sided|95.0|0.2|0.76|||||Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age stratum + Baseline HbA1c.|This was the primary gated analysis.|
1691307|NCT01109108|3109637|Other||Risk Ratio (RR)|1.0|||<|0.05|2-Sided|95.0|||||Chi-squared||||
1691308|NCT01109004|3109651|Superiority|||||||0.33||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.|
1691309|NCT01109004|3109651|Superiority|||||||0.15||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.|
1691310|NCT01109004|3109651|Superiority|||||||0.63||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with TRM at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.|
1691311|NCT01109004|3109652|Superiority|||||||0.57||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.|
1691312|NCT01109004|3109652|Superiority|||||||0.53||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.|
1691313|NCT01109004|3109652|Superiority|||||||0.26||||||Two sided testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that the percentages of participants with OS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.|
1691332|NCT01108445|3109709|Superiority or Other|||||||0.066|||||||Chi-squared||||
1691333|NCT01108445|3109710|Superiority or Other|||||||0.589|||||||Chi-squared||||
1691314|NCT01109004|3109653|Superiority|||||||0.22||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.|
1691315|NCT01109004|3109653|Superiority|||||||0.21||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.|
1691316|NCT01109004|3109653|Superiority|||||||0.92||||||Two sided testing was performed at a significance level of 0.05|Gray's test|Death prior to disease progression was treated as a competing risk||The null hypothesis is that the percentages of participants with disease progression at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.|
1691317|NCT01109004|3109654|Superiority|||||||0.27||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.|
1691318|NCT01109004|3109654|Superiority|||||||0.37||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.|
1691319|NCT01109004|3109654|Superiority|||||||0.87||||||The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.|Log Rank|The log rank test was stratified on risk status (high risk vs. standard risk)||The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.|
1691320|NCT01108731|3109678|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1691321|NCT01108731|3109679|Superiority or Other||||||<|0.05|||||||General Linear Model (GLM)||||
1691322|NCT01108731|3109680|Superiority or Other||||||<|0.05|||||||General Linear Model (GLM)||||
1691323|NCT01108718|3109681|Superiority or Other||Rate of Preference|0.45|Standard Deviation|0.5|>|0.1|2-Sided|95.0|0.43|0.47|||McNemar||Rate of preference refers specifically to Tempur-Pedic Mattress.|h0: Rate Preference Tempur-pedic mattress = Rate Preference control mattress h1: Rate Preference Tempur-pedic mattress = Rate Preference control mattress|
1691324|NCT01108510|3109684|Superiority or Other||Difference in LSM|6.0||||0.84|2-Sided|95.0|-55.0|67.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.||
1691325|NCT01108510|3109685|Superiority or Other||Difference in LSM|-22.0||||0.18|2-Sided|95.0|-54.0|10.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.||
1691326|NCT01108510|3109686|Superiority or Other||Difference in LSM|-10.0||||0.51|2-Sided|95.0|-38.0|19.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.||
1691327|NCT01108510|3109687|Superiority or Other||Difference in least squares mean (LSM)|-5.0||||0.67|2-Sided|95.0|-28.0|18.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.||
1691328|NCT01108510|3109688|Non-Inferiority or Equivalence|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-8.0|||||2-Sided|95.0|-22.2|6.3|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.||
1691329|NCT01108510|3109689|Non-Inferiority or Equivalence|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-2.1|||||2-Sided|95.0|-8.7|4.5|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.||
1691330|NCT01108510|3109690|Non-Inferiority or Equivalence|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-1.4|||||2-Sided|95.0|-7.6|4.7|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.||
1691331|NCT01108510|3109691|Non-Inferiority or Equivalence|Null hypothesis: ATV+COBI+FTC/TDF group was at least 12% worse than the ATV+RTV+FTC/TDF group; alternative hypothesis: ATV+COBI+FTC/TDF group was less than 12% worse than the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95.2% confidence interval (CI) (COBI group - RTV group) was > -12%.|Difference in percentages|-2.2|||||2-Sided|95.2|-7.4|3.0|||||Difference in percentages of success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|700 planned subjects had 95% power to evaluate noninferiority assuming a response rate of 79.5% for both arms and a noninferiority margin of 12%.|
1691334|NCT01108445|3109712|Superiority or Other||Median PFS|8.3|||||2-Sided||||||||95% CI for HC was(4,6). If the median PFS for Sunitinib is within the 95% CI for the HC,it is determined that there is not enough statistical evidence to say that the median PFS is different than the HC.|A comparison of the median PFS for Sunitinib arm was compared to the 95% confidence interval(CI) of the median PFS of the historical control (HC). The null hypothesis was that there is no difference in the median PFS between the treatment arms and the historical control. If the median PFS is outside the 95%CI for the HC,it is determined there is statistical evidence that median PFS is different from the HC.|
1691335|NCT01108445|3109712|Superiority or Other||Median PFS|5.6|||||2-Sided||||||||The 95% CI for the HC was (4,6). If the median PFS for RAD001 is within the 95% CI for the HC, it is determined that there is not enough statistical evidence to say that the median PFS is different than the HC.|A comparison of the median PFS for RAD001 arm was compared to the 95% confidence interval(CI) of the median PFS of the historical control (HC). The null hypothesis was that there is no difference in the median PFS between the treatment arms and the historical control. If the median PFS is outside the 95%CI for the HC,it is determined there is statistical evidence that median PFS is different from the HC.|
1691336|NCT01108445|3109714|Superiority or Other||Hazard Ratio (HR)|1.406||||0.157|2-Sided||||||Log Rank||||
1691337|NCT01108094|3109736|Other|||||||0.435|||||||t-test, 1 sided|||Average tumor size reductions were compared between Cohort A1 and Cohort B.|
1691338|NCT01108094|3109736|Other||Mean Difference (Final Values)|24.0|||||2-Sided|95.0|18.2|30.0||||||Only tumors from 4 patients from cohort A (n = 42 BCCs) and all tumors from the 4 patients (n = 14 BCCs) in cohort B were observed for tumor size change. Percent change in tumor area from both cohorts (eight patients total with 57 tumors) was calculated only.|
1691339|NCT01108094|3109737|Other|||||||0.028|||||||t-test, 2 sided|||"Percentage change in GLI1 messenger RNA (mRNA) expression Paired analysis of tumors shows percent change between baseline (prior to treatment) and post itraconazole treatment in individual patients.~% change was calculated from the difference between the mean of baseline Gli levels and the mean Gli level after 1 month of treatment."|Wilcoxon signed rank test
1691340|NCT01108094|3109738|Other|||||||0.652|||||||t-test, 2 sided|||"Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - control patients Paired analysis of tumors shows percent change between baseline and after 1 month in individual patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month."|
1691341|NCT01108094|3109738|Other|||||||0.079|||||||t-test, 1 sided|||"Percent change in Ki67 tumor proliferation biomarker - baseline vs 1 month - Cohort A, vismodegib-naive (n = 8) vs control patients Unpaired analysis shows percent change between individual tumors from control patients and itraconazole treated patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment."|
1691342|NCT01108094|3109738|Other|||||||0.04|||||||t-test, 2 sided|||"Percent change in Ki67 tumor proliferation biomarker from baseline to 1 month, for Cohort A1 (vismodegib-naive patients, n = 8).~Paired analysis of tumors shows percent change between baseline (prior to treatment) and post-itraconazole treatment in individual patients.~% change was calculated from the difference between the mean of baseline Ki67 levels and the mean Ki67 levels after 1 month of treatment."|
1691343|NCT01108068|3109742|Equivalence|Continuous variables were expressed as means ± SD or median (range). Group differences in pQCT Z-scores according to genotype||||||0.001|||||||t-test, 1 sided|Differences in the two groups were assessed using Student's t-test or the rank-sum test if skewed.||Periosteal circumference Z-score|
1691344|NCT01108068|3109742|Equivalence|Continuous variables were expressed as means ± SD or median (range). Group differences in pQCT Z-scores according to genotype T-test was used to compare differences at baseline between affecteds and unaffecteds||||||0.0003|||||||t-test, 1 sided|Differences in the two groups were assessed using Student's t-test or the rank-sum test if skewed.||Cortical area Z-score|
1691345|NCT01107964|3109750|Superiority|||||||0.48|||||||Wilcoxon (Mann-Whitney)||||
1691346|NCT01107964|3109751|Superiority|||||||0.44|||||||Wilcoxon (Mann-Whitney)||||
1691347|NCT01107964|3109752|Superiority|||||||0.57|||||||Wilcoxon (Mann-Whitney)||||
1691348|NCT01107964|3109753|Superiority|||||||0.61|||||||Wilcoxon (Mann-Whitney)||||
1691349|NCT01107925|3109758|Non-Inferiority or Equivalence|Difference in median MPA in response to 20 μM ADP in LBW participants who received 5 mg prasugrel to the 75th percentile of MPA response to 20 μM ADP in HBW participants who received10 mg prasugrel at the end of Study Period 1 (Baseline through Day 12) was estimated from the observed data.|Estimate of the difference|-10.1||||0.526|2-Sided|95.0|-23.4|0.2|||bootstrap (to determine 95% CI)||Estimate of the difference = [median (low body weight) - Q3 (higher body weight)]||
1691350|NCT01107912|3109763|Non-Inferiority or Equivalence|The difference of median MPA to 20 μM ADP of a prasugrel 5-mg in the elderly group to the 75th percentile of the MPA to 20 μM ADP of a prasugrel 10 mg MD in the non-elderly group at the end of Period 1 was estimated from the observed data. The upper limit of the one-sided 97.5% confidence interval for the difference was estimated from resampling data with replacement through bootstrap methodology and was used to compare with the non-inferiority margin of 15 percentage points.|Estimate of the difference|6.0|||||2-Sided|95.0|1.0|9.0|||||||
1691351|NCT01107899|3109771|Superiority or Other|||||||0.025|||||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.|||
1691352|NCT01107899|3109771|Superiority or Other||||||<|0.001|||||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.|||
1691353|NCT01107899|3109771|Superiority or Other||||||<|0.001|||||||ANCOVA|p-value was obtained from an analysis of covariance model with treatment as a fixed effect and the baseline value as a covariate.|||
1691354|NCT01107899|3109773|Superiority or Other||||||<|0.001||||||P-value is for the overall effect of initial inhibition on the day to return to baseline platelet function.|Regression, Linear||||
1691355|NCT01107834|3109781|Superiority or Other|||||||0.03|||||||t-test, 2 sided|||T-test to detect differences between groups|
1691356|NCT01107834|3109782|Superiority or Other|||||||0.09|||||||t-test, 2 sided|||T-test to detect differences between groups|
1691357|NCT01107834|3109783|Superiority or Other|||||||0.59|||||||t-test, 2 sided|||T-test to detect differences between groups|
1691358|NCT01107834|3109784|Superiority or Other|||||||0.13|||||||t-test, 2 sided|||T-test to detect differences between groups|
1691359|NCT01107834|3109785|Superiority or Other|||||||0.46|||||||t-test, 2 sided|||T-test to detect differences between groups|
1691360|NCT01107834|3109786|Superiority or Other|||||||0.27|||||||t-test, 2 sided|||T-test to detect differences between groups|
1691361|NCT01107743|3109788|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."|
1691362|NCT01107743|3109789|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."|
1691363|NCT01107743|3109790|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."|
1691364|NCT01107743|3109791|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."|
1691365|NCT01107743|3109792|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the participants of responders."|
1691366|NCT01107743|3109793|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between <65 years and >=65 years in the participants of responders."|
1691367|NCT01107743|3109794|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."|
1691368|NCT01107743|3109795|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."|
1691369|NCT01107743|3109796|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."|
1691370|NCT01107743|3109797|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."|
1691371|NCT01107743|3109798|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."|
1691372|NCT01107743|3109799|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Angina Pectoris Severity. The null hypothesis is there is no difference among Class1, Class2, Class3, and Class4 in the participants of responders."|
1691373|NCT01107743|3109800|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between <65 years and >=65 years in the participants of responders."|
1691374|NCT01107743|3109801|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."|
1691375|NCT01107743|3109802|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with and without Concomitant Drugs in the participants of responders."|
1691376|NCT01107743|3109803|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with and without Complications in the participants of responders."|
1691377|NCT01107743|3109804|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the participants of responders."|
1691378|NCT01107743|3109805|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the participants of responders."|
1691379|NCT01107743|3109806|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the participants of responders."|
1691380|NCT01107743|3109807|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between <65 years and >=65 years in the participants of responders."|
1691381|NCT01107743|3109808|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participants of responders."|
1691382|NCT01107743|3109809|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Concomitant Drugs. The null hypothesis is there is no difference between with Concomitant Drugs and without Concomitant Drugs in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."|
1691383|NCT01107743|3109810|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Complications. The null hypothesis is there is no difference between with Complications and without Complications in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."|
1691384|NCT01107743|3109811|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with Renal Dysfunction and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."|
1691385|NCT01107743|3109812|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with Hepatic Dysfunction and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."|
1691422|NCT01106846|3109948|Superiority or Other|||||||0.947|||||||Wilcoxon (Mann-Whitney)||||
1691386|NCT01107743|3109813|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Familial Hypercholesterolemia. The null hypothesis is there is no difference between with Familial Hypercholesterolemia and without Familial Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."|
1691387|NCT01107743|3109814|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia expression type. The null hypothesis is there is no difference among expression type Ⅰ, expression type Ⅱa, expression type Ⅱb, expression type Ⅲ, expression type, expression type Ⅳ, and expression type Ⅴ in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."|
1691388|NCT01107743|3109815|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Hypercholesterolemia. The null hypothesis is there is no difference between with Hypercholesterolemia and without Hypercholesterolemia in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."|
1691389|NCT01107743|3109816|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Angina Pectoris. The null hypothesis is there is no difference between with Angina Pectoris and without Angina Pectoris in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."|
1691390|NCT01107743|3109817|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Hypertension severity. The null hypothesis is there is no difference among ClassⅠHypertension, ClassⅡ Hypertension, and ClassⅢ Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."|
1691391|NCT01107743|3109818|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Hypertension. The null hypothesis is there is no difference between with Hypetension and without Hypertension in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."|
1691392|NCT01107743|3109819|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between <65 years and >=65 years in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."|
1691393|NCT01107743|3109820|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between male and female in the Incidence Rate of Treatment Related Adverse Events(TRAEs)."|
1691394|NCT01107665|3109827|Other||Log Rank HR|0.784||||0.49|2-Sided|95.0|0.41|1.54|||Log Rank||||
1691395|NCT01107457|3109873|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1691396|NCT01107457|3109873|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1691397|NCT01107457|3109873|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1691398|NCT01107457|3109873|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1691399|NCT01107457|3109874|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact||||
1691400|NCT01107457|3109874|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact||||
1691401|NCT01107457|3109874|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact||||
1691402|NCT01107457|3109874|Superiority or Other (legacy)||||||<|0.079|||||||Fisher Exact||||
1691403|NCT01107444|3109887|Superiority or Other (legacy)|||||||0.284||||||The t-test was based on the logarithm of the ratio of tumor size at Cycle 2 to that at baseline as this measure follows a normal distribution.|t-test, 1 sided||||
1691404|NCT01107015|3109929|Superiority||Mean Difference (Net)|0.05||||0.001|2-Sided||||||Mixed Models Analysis|||Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin.|
1691405|NCT01107015|3109929|Other|Sample size was determined on the basis of the primary outcome, change in glycated hemoglobin. The comparison of UC, which included 56 patients from nine practices, to CPDS, which included 62 patients from seven practices, had 80% power to detect a difference in mean glycated hemoglobin changes of 0.65 SD, corresponding to 1.0% if SD was 1.58%, using a two-sided test with 0.05 type I error after accounting for a within cluster correlation of 0.10.||||||0.027||||||CO (P = 0.027) and CPP (0.40) mean HbA1c levels decreased over 12 months.|Mixed Models Analysis|||Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin. Secondary analyses jointly compared 3-, 6-, 9-, and 12-month changes between groups. Random effects accounted for within-practice clustering and within-patient correlation.|
1691406|NCT01106976|3109930|Superiority or Other||Mean Difference (Net)|0.0012||||0.0009|2-Sided||||||t-test, 1 sided|||Paired t-test. Hypothesis of significant cholinergic interval changes over the study interval period.|
1691407|NCT01106859|3109939|Superiority or Other|||||||0.0001||||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.|
1691408|NCT01106859|3109939|Superiority or Other|||||||0.0156||||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.|
1691409|NCT01106859|3109939|Superiority or Other|||||||0.5||||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-3.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.|
1691563|NCT01106430|3110031|Superiority or Other||Difference in LS Means|-6.5|||<|0.001|2-Sided|95.0|-9.3|-3.6|||ANCOVA||||
1691410|NCT01106859|3109941|Superiority or Other||||||<|0.0001||||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of Zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.|
1691411|NCT01106859|3109941|Superiority or Other||||||<|0.0074||||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.|
1691412|NCT01106859|3109941|Superiority or Other||||||<|0.125||||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.0 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.|
1691413|NCT01106859|3109943|Superiority or Other||||||<|0.0001||||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zopiclone 9 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.|
1691414|NCT01106859|3109943|Superiority or Other||||||<|0.0117||||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 3 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.|
1691415|NCT01106859|3109943|Superiority or Other||||||<|0.2188||||||No adjustments. The a priori threshold for statistical significance is 0.05.|McNemar|McNemar's exact test with one degree of freedom is used.||Symmetry analysis was performed for the probability of difference from placebo falling above and below the threshold of +/-2.5 cm in Standard Deviation of Lateral Position (SDLP) following administration of zolpidem tartrate sublingual tablet 4 hours prior to driving. Statistically significant asymmetries indicate a decrement in driving performance. Lack of statistical significance indicates symmetry which shows a lack of treatment effect on driving performance.|
1691416|NCT01106859|3109946|Superiority or Other||Mean Difference (Final Values)|0.16||||0.0096|2-Sided|95.0|0.04|0.29||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zopiclone) – LS mean of SDS (Placebo).|
1691417|NCT01106859|3109946|Superiority or Other||Mean Difference (Final Values)|0.08||||0.2179|2-Sided|95.0|-0.05|0.2||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 3 Hours) – LS mean of SDS (Placebo).|
1691418|NCT01106859|3109946|Superiority or Other||Mean Difference (Final Values)|0.15||||0.0145|2-Sided|95.0|0.03|0.27||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 113 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDS (Zolpidem 4 hours prior) – LS mean of SDS (Placebo).|
1691419|NCT01106859|3109947|Superiority or Other||Mean Difference (Final Values)|2.5|||<|0.0001|2-Sided|95.0|1.8|3.1||No p-value adjustment for multiple comparisons|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zopiclone) – LS mean of SDLP (Placebo).|
1691420|NCT01106859|3109947|Superiority or Other||Mean Difference (Final Values)|1.5|||<|0.0001|2-Sided|95.0|0.8|2.1||No p-value adjustment for multiple comparisons.|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 3 Hours) – LS mean of SDLP (Placebo).|
1691421|NCT01106859|3109947|Superiority or Other||Mean Difference (Final Values)|0.8|||<|0.0174|2-Sided|95.0|0.1|1.5||No p-value adjustment for multiple comparisons.|ANOVA|The degrees of freedom are 114 for the p-value testing the difference between treatment groups.||P-value is based on ANOVA model with fixed effects for sequence, period and treatment, a random effect for subject within sequence, and assuming compound symmetry covariance structure; the p-value is reported from LS Mean difference between Treatment Groups: LS mean of SDLP (Zolpidem 4 Hours) – LS mean of SDLP (Placebo).|
1691423|NCT01106833|3109949|Superiority|||||||0.309||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691424|NCT01106833|3109949|Superiority|||||||0.398||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691425|NCT01106833|3109949|Superiority|||||||0.953||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691426|NCT01106833|3109949|Superiority|||||||0.133||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691427|NCT01106833|3109949|Superiority|||||||0.763||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean FACT-BMT scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691428|NCT01106833|3109950|Superiority|||||||0.527||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691429|NCT01106833|3109950|Superiority|||||||0.222||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691430|NCT01106833|3109950|Superiority|||||||0.391||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691431|NCT01106833|3109950|Superiority|||||||0.759||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691432|NCT01106833|3109950|Superiority|||||||0.631||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean MCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691433|NCT01106833|3109951|Superiority|||||||0.804||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 2 years are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691434|NCT01106833|3109951|Superiority|||||||0.278||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 1 year are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691435|NCT01106833|3109951|Superiority|||||||0.039||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 6 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691436|NCT01106833|3109951|Superiority|||||||0.105||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at 2 months are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691437|NCT01106833|3109951|Superiority|||||||0.685||||||Two-sided testing was performed using a significance level of 0.05|t-test, 2 sided|Independent samples t-test||The null hypothesis is that the mean PCS scores at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691438|NCT01106833|3109952|Superiority|||||||0.554||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691439|NCT01106833|3109952|Superiority|||||||0.756||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691440|NCT01106833|3109952|Superiority|||||||0.546||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691441|NCT01106833|3109952|Superiority|||||||0.238||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the NIH Consensus Criteria severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691442|NCT01106833|3109953|Superiority|||||||0.444||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691443|NCT01106833|3109953|Superiority|||||||0.75||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691444|NCT01106833|3109953|Superiority|||||||0.301||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691445|NCT01106833|3109953|Superiority|||||||0.45||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the provider-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691446|NCT01106833|3109954|Superiority|||||||0.369||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 2 years post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691447|NCT01106833|3109954|Superiority|||||||0.036||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 1 year post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691448|NCT01106833|3109954|Superiority|||||||0.258||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at 6 months post-randomization are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691449|NCT01106833|3109954|Superiority|||||||0.62||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportions of patients in the patient-reported severity and vital status categories considered at baseline are equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691450|NCT01106833|3109955|Superiority|||||||0.863||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in serum creatinine level from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691451|NCT01106833|3109955|Superiority|||||||0.147||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in serum creatinine level from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691452|NCT01106833|3109956|Superiority|||||||0.431||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691453|NCT01106833|3109956|Superiority|||||||0.208||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691454|NCT01106833|3109956|Superiority|||||||0.582||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median serum creatinine level at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691455|NCT01106833|3109957|Superiority|||||||0.14||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in prednisone dose from baseline to 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691456|NCT01106833|3109957|Superiority|||||||0.586||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median change in prednisone dose from baseline to 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691457|NCT01106833|3109958|Superiority|||||||0.129||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at 1 year post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691458|NCT01106833|3109958|Superiority|||||||0.562||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at 6 months post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691459|NCT01106833|3109958|Superiority|||||||0.127||||||Two-sided testing was performed using a significance level of 0.05|Kruskal-Wallis|||The null hypothesis is that the median prednisone dose at baseline is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691490|NCT01106677|3109977|Superiority or Other||Least-Squares Mean Difference|-2.9|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-3.4|-2.3|||ANCOVA||||
1691460|NCT01106833|3109959|Superiority|||||||0.706||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without discontinuation of systemic immunosuppressive therapy is considered a competing risk for this endpoint||The null hypothesis is that the rate of discontinuation of systemic immunosuppressive therapy during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691461|NCT01106833|3109960|Superiority|||||||0.219||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without initiation of secondary therapy is considered a competing risk for this endpoint||The null hypothesis is that the rate of initiation of secondary immunosuppressive therapy for chronic GVHD during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691462|NCT01106833|3109961|Superiority|||||||0.396||||||Two-sided testing was performed using a significance level of 0.05|Gray's test|Death without relapse was treated as a competing risk||The null hypothesis is that the rate of relapse during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691463|NCT01106833|3109962|Superiority|||||||0.775||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of failure-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691464|NCT01106833|3109963|Superiority|||||||0.141||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of progression-free survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691465|NCT01106833|3109964|Superiority|||||||0.205||||||Two-sided testing was performed using a significance level of 0.05|Log Rank|||The null hypothesis is that the rate of overall survival during the first two years post-randomization is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691466|NCT01106833|3109965|Superiority|||||||0.44||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportion of participants with treatment success at 24 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691467|NCT01106833|3109965|Superiority|||||||0.63||||||Two-sided testing was performed using a significance level of 0.05|Fisher Exact|||The null hypothesis is that the proportion of participants with treatment success at 6 months is equal for those receiving either Sirolimus, Calcineurin Inhibitor, and Prednisone or Sirolimus and Prednisone for treatment of chronic GVHD.|
1691468|NCT01106690|3109966|Superiority or Other||Least-Squares Mean Difference|6.5|Standard Error of the Mean|1.9|<|0.001|2-Sided|95.0|2.8|10.2|||ANCOVA||||
1691469|NCT01106690|3109966|Superiority or Other||Least-Squares Mean Difference|4.8|Standard Error of the Mean|1.9|<|0.01|2-Sided|95.0|1.2|8.5|||ANCOVA||||
1691470|NCT01106690|3109967|Superiority or Other||Least-Squares Mean Difference|-16.9|Standard Error of the Mean|5.7||0.003|2-Sided|95.0|-28.1|-5.8|||ANCOVA||||
1691471|NCT01106690|3109967|Superiority or Other||Least-Squares Mean Difference|-12.1|Standard Error of the Mean|5.7||0.034|2-Sided|95.0|-12.1|-0.9|||ANCOVA||||
1691472|NCT01106690|3109968|Superiority or Other||Least-Squares Mean Difference|-3.46|Standard Error of the Mean|1.433||0.016|2-Sided|95.0|-6.281|-0.643|||ANCOVA||||
1691473|NCT01106690|3109968|Superiority or Other||Least-Squares Mean Difference|-4.07|Standard Error of the Mean|1.43||0.005|2-Sided|95.0|-6.879|-1.251|||ANCOVA||||
1691474|NCT01106690|3109969|Superiority or Other||Least-Squares Mean Difference|-3.7|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-4.6|-2.8|||ANCOVA||||
1691475|NCT01106690|3109969|Superiority or Other||Least-Squares Mean Difference|-2.7|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-3.6|-1.8|||ANCOVA||||
1691476|NCT01106690|3109970|Superiority or Other||Least-Squares Mean Difference|17.23|Standard Error of the Mean|2.509|<|0.001|2-Sided|95.0|12.293|22.166|||ANCOVA||||
1691477|NCT01106690|3109970|Superiority or Other||Least-Squares Mean Difference|14.28|Standard Error of the Mean|2.521|<|0.001|2-Sided|95.0|9.315|19.236|||ANCOVA||||
1691478|NCT01106690|3109971|Superiority or Other||Least-Squares Mean Difference|-35.7|Standard Error of the Mean|3.861|<|0.001|2-Sided|95.0|-43.3|-28.11|||ANCOVA||||
1691479|NCT01106690|3109971|Superiority or Other||Least-Squares Mean Difference|-29.4|Standard Error of the Mean|3.857|<|0.001|2-Sided|95.0|-36.96|-21.78|||ANCOVA||||
1691480|NCT01106690|3109972|Superiority or Other||Odds Ratio (OR)|5.38|||<|0.001|2-Sided|95.0|2.73|10.6|||Regression, Logistic||||
1691481|NCT01106690|3109972|Superiority or Other||Odds Ratio (OR)|2.4|||<|0.007||95.0|1.26|4.57|||Regression, Logistic||||
1691482|NCT01106690|3109973|Superiority or Other||Least-Squares Mean Difference|-0.76|Standard Error of the Mean|0.096|<|0.001|2-Sided|95.0|-0.951|-0.575|||ANCOVA||||
1691483|NCT01106690|3109973|Superiority or Other||Least-Squares Mean Difference|-0.62|Standard Error of the Mean|0.095|<|0.001|2-Sided|95.0|-0.811|-0.437|||ANCOVA||||
1691484|NCT01106677|3109974|Superiority or Other||Least-Squares Mean Difference|7.3|Standard Error of the Mean|1.4|<|0.001|2-Sided|95.0|4.5|10.1|||ANCOVA||||
1691485|NCT01106677|3109974|Superiority or Other||Least-Squares Mean Difference|5.2|Standard Error of the Mean|1.4|<|0.001|2-Sided|95.0|2.5|8.0|||ANCOVA||||
1691486|NCT01106677|3109975|Superiority or Other||Least-Squares Mean Difference|3.2|Standard Error of the Mean|3.2||0.323|2-Sided|95.0|-3.1|9.4|||ANCOVA||||
1691487|NCT01106677|3109975|Superiority or Other||Least-Squares Mean Difference|2.3|Standard Error of the Mean|3.2||0.466|2-Sided|95.0|-3.9|8.5|||ANCOVA||||
1691488|NCT01106677|3109976|Superiority or Other||Least-Squares Mean Difference|-3.99|Standard Error of the Mean|0.815|<|0.001|2-Sided|95.0|-5.589|-2.389|||ANCOVA||||
1691489|NCT01106677|3109976|Superiority or Other||Least-Squares Mean Difference|-2.87|Standard Error of the Mean|0.812|<|0.001|2-Sided|95.0|-4.464|-1.276|||ANCOVA||||
1691562|NCT01106430|3110030|Superiority or Other||Difference in LS Means|-0.09||||0.046|2-Sided|95.0|-0.17|0.0|||ANCOVA||||
1691491|NCT01106677|3109977|Superiority or Other||Least-Squares Mean Difference|-2.4|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-3.0|-1.8|||ANCOVA||||
1691492|NCT01106677|3109978|Superiority or Other||Least-Squares Mean Difference|-17.5|Standard Error of the Mean|2.404|<|0.001|2-Sided|95.0|-22.24|-12.81|||ANCOVA||||
1691493|NCT01106677|3109978|Superiority or Other||Least-Squares Mean Difference|-8.55|Standard Error of the Mean|2.394|<|0.001|2-Sided|95.0|-13.25|-3.857|||ANCOVA||||
1691494|NCT01106677|3109979|Non-Inferiority or Equivalence|Assuming a discontinuation rate of 35% at Week 52, with a 2:2:2:1 treatment assignment ratio for canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 mg, or placebo, it was estimated that 360 subjects would need to be randomly assigned to each of the 3 active treatment groups and approximately 180 subjects to the placebo group to demonstrate non-inferiority with a non-inferiority margin of 0.3%.|Least-Squares Mean Difference|-0.15|Standard Error of the Mean|0.062|||2-Sided|95.0|-0.273|-0.031|||||||
1691495|NCT01106677|3109979|Non-Inferiority or Equivalence|Assuming a discontinuation rate of 35% at Week 52, with a 2:2:2:1 treatment assignment ratio for canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 mg, or placebo, it was estimated that 360 subjects would need to be randomly assigned to each of the 3 active treatment groups and approximately 180 subjects to the placebo group to demonstrate non-inferiority with a non-inferiority margin of 0.3%.|Least-Squares Mean Difference|0.0|Standard Error of the Mean|0.061|||2-Sided|95.0|-0.119|0.122|||||||
1691496|NCT01106677|3109980|Superiority or Other||Least-Squares Mean Difference|1.3|Standard Error of the Mean|1.6|||2-Sided|95.0|-1.7|4.4|||||||
1691497|NCT01106677|3109980|Superiority or Other||Least-Squares Mean Difference|8.5|Standard Error of the Mean|1.6|<|0.001|2-Sided|95.0|5.4|11.5|||ANCOVA||||
1691498|NCT01106677|3109980|Superiority or Other||Least-Squares Mean Difference|6.7|Standard Error of the Mean|1.6|<|0.001|2-Sided|95.0|3.6|9.7|||ANCOVA||||
1691499|NCT01106677|3109981|Superiority or Other||Least-Squares Mean Difference|-2.3|Standard Error of the Mean|4.3|||2-Sided|95.0|-10.6|6.1|||||||
1691500|NCT01106677|3109981|Superiority or Other||Least-Squares Mean Difference|-4.7|Standard Error of the Mean|4.3||0.274|2-Sided|95.0|-13.0|3.7|||ANCOVA||||
1691501|NCT01106677|3109981|Superiority or Other||Least-Squares Mean Difference|-1.6|Standard Error of the Mean|4.2||0.702||95.0|-9.9|6.7|||ANCOVA||||
1691502|NCT01106677|3109982|Superiority or Other||Least-Squares Mean Difference|-3.34|Standard Error of the Mean|0.984|||2-Sided|95.0|-5.273|-1.413|||||||
1691503|NCT01106677|3109982|Superiority or Other||Least-Squares Mean Difference|-6.58|Standard Error of the Mean|0.981|<|0.001|2-Sided|95.0|-8.504|-4.653|||ANCOVA||||
1691504|NCT01106677|3109982|Superiority or Other||Least-Squares Mean Difference|-5.36|Standard Error of the Mean|0.979|<|0.001|2-Sided|95.0|-7.28|-3.439|||ANCOVA||||
1691505|NCT01106677|3109983|Superiority or Other||Least-Squares Mean Difference|0.0|Standard Error of the Mean|0.3|||2-Sided|95.0|-0.6|0.6|||||||
1691506|NCT01106677|3109983|Superiority or Other||Least-Squares Mean Difference|-2.9|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-3.5|-2.3|||ANCOVA||||
1691507|NCT01106677|3109983|Superiority or Other||Least-Squares Mean Difference|-2.5|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-3.1|-1.9|||ANCOVA||||
1691508|NCT01106677|3109984|Superiority or Other||Least-Squares Mean Difference|-39.6|Standard Error of the Mean|5.608|||2-Sided|95.0|-50.56|-28.55|||||||
1691509|NCT01106677|3109984|Superiority or Other||Least-Squares Mean Difference|-47.3|Standard Error of the Mean|5.635|<|0.001|2-Sided|95.0|-58.4|-36.29|||ANCOVA||||
1691510|NCT01106677|3109984|Superiority or Other||Least-Squares Mean Difference|-38.1|Standard Error of the Mean|5.601|<|0.001|2-Sided|95.0|-49.14|-27.16|||ANCOVA||||
1691511|NCT01106677|3109985|Superiority or Other||Least-Squares Mean Difference|-22.7|Standard Error of the Mean|3.06|||2-Sided|95.0|-28.7|-16.69|||||||
1691512|NCT01106677|3109985|Superiority or Other||Least-Squares Mean Difference|-40.3|Standard Error of the Mean|3.055|<|0.001|2-Sided|95.0|-46.25|-34.26|||ANCOVA||||
1691513|NCT01106677|3109985|Superiority or Other||Least-Squares Mean Difference|-29.8|Standard Error of the Mean|3.044|<|0.001|2-Sided|95.0|-35.76|-23.81|||ANCOVA||||
1691514|NCT01106677|3109986|Superiority or Other||Odds Ratio (OR)|4.39|||<|0.001|2-Sided|95.0|2.85|6.77|||Regression, Logistic||||
1691515|NCT01106677|3109986|Superiority or Other||Odds Ratio (OR)|2.29|||<|0.001|2-Sided|95.0|1.5|3.5|||Regression, Logistic||||
1691516|NCT01106677|3109987|Superiority or Other||Least-Squares Mean Difference|-0.66|Standard Error of the Mean|0.071|||2-Sided|95.0|-0.795|-0.516|||||||
1691517|NCT01106677|3109987|Non-Inferiority or Equivalence|Power calculation: assuming a difference between canagliflozin and placebo of 0.5% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.05, it was estimated that 86 subjects per group would provide 90% power to demonstrate superiority of canagliflozin over placebo.|Least-Squares Mean Difference|-0.77|Standard Error of the Mean|0.071|<|0.001|2-Sided|95.0|-0.914|-0.636|||ANCOVA||||
1691518|NCT01106677|3109987|Non-Inferiority or Equivalence|Power calculation: assuming a difference between canagliflozin and placebo of 0.5% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.05, it was estimated that 86 subjects per group would provide 90% power to demonstrate superiority of canagliflozin over placebo.|Least-Squares Mean Difference|-0.62|Standard Error of the Mean|0.071|<|0.001|2-Sided|95.0|-0.758|-0.481|||ANCOVA||||
1691519|NCT01106651|3109988|Superiority or Other||Least-Squares Mean Difference|-0.5|Standard Error of the Mean|0.2|||2-Sided|95.0|-0.9|-0.1|||||||
1691520|NCT01106651|3109988|Superiority or Other||Least-Squares Mean Difference|-0.4|Standard Error of the Mean|0.2|||2-Sided|95.0|-0.8|0.0|||||||
1691521|NCT01106651|3109989|Superiority or Other||Least-Squares Mean Difference|0.4|Standard Error of the Mean|0.3|||2-Sided|95.0|-0.3|1.1|||||||
1691522|NCT01106651|3109989|Superiority or Other||Least-Squares Mean Difference|0.3|Standard Error of the Mean|0.3|||2-Sided|95.0|-0.3|1.0|||||||
1691523|NCT01106651|3109990|Superiority or Other||Least-Squares Mean Difference|-0.4|Standard Error of the Mean|0.3|||2-Sided|95.0|-1.0|0.3|||||||
1691524|NCT01106651|3109990|Superiority or Other||Least-Squares Mean Difference|-0.3|Standard Error of the Mean|0.3|||2-Sided|95.0|-0.9|0.4|||||||
1691525|NCT01106651|3109991|Superiority or Other||Least-Squares Mean Difference|-0.3|Standard Error of the Mean|0.3|||2-Sided|95.0|-0.9|0.3|||||||
1691526|NCT01106651|3109991|Superiority or Other||Least-Squares Mean Difference|0.2|Standard Error of the Mean|0.3|||2-Sided|95.0|-0.4|0.8|||||||
1691527|NCT01106651|3109992|Superiority or Other||Least-Squares Mean Difference|4.7|Standard Error of the Mean|1.4|<|0.001|2-Sided|95.0|2.0|7.4|||ANCOVA||||
1691528|NCT01106651|3109992|Superiority or Other||Least-Squares Mean Difference|5.3|Standard Error of the Mean|1.4|<|0.001|2-Sided|95.0|2.6|7.9|||ANCOVA||||
1691529|NCT01106651|3109993|Superiority or Other||Least-Squares Mean Difference|0.7|Standard Error of the Mean|3.7||0.846|2-Sided|95.0|-6.6|8.1|||ANCOVA||||
1691530|NCT01106651|3109993|Superiority or Other||Least-Squares Mean Difference|-4.8|Standard Error of the Mean|3.7||0.194|2-Sided|95.0|-12.1|2.5|||ANCOVA||||
1691531|NCT01106651|3109994|Superiority or Other||Least-Squares Mean Difference|-7.89|Standard Error of the Mean|1.147|<|0.001|2-Sided|95.0|-10.14|-5.641|||ANCOVA||||
1691532|NCT01106651|3109994|Superiority or Other||Least-Squares Mean Difference|-4.63|Standard Error of the Mean|1.134|<|0.001|2-Sided|95.0|-6.854|-2.401|||ANCOVA||||
1691533|NCT01106651|3109995|Superiority or Other||Least-Squares Mean Difference|-1.2|Standard Error of the Mean|0.311|<|0.001|2-Sided|95.0|-1.812|-0.584|||ANCOVA||||
1691534|NCT01106651|3109995|Superiority or Other||Least-Squares Mean Difference|-1.05|Standard Error of the Mean|0.316|<|0.001|2-Sided|95.0|-1.677|-0.43|||ANCOVA||||
1691535|NCT01106651|3109996|Superiority or Other||Least-Squares Mean Difference|-1.18|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-1.772|-0.587|||ANCOVA|||Region percent total fat|
1691536|NCT01106651|3109996|Superiority or Other||Least-Squares Mean Difference|-1.03|Standard Error of the Mean|0.305|<|0.001|2-Sided|95.0|-1.633|-0.428|||ANCOVA|||Region percent total fat|
1691537|NCT01106651|3109997|Superiority or Other||Least-Squares Mean Difference|-2.1|Standard Error of the Mean|0.371|<|0.001|2-Sided|95.0|-2.833|-1.368|||ANCOVA||||
1691538|NCT01106651|3109997|Superiority or Other||Least-Squares Mean Difference|-1.59|Standard Error of the Mean|0.379|<|0.001|2-Sided|95.0|-2.339|-0.842|||ANCOVA||||
1691539|NCT01106651|3109998|Superiority or Other||Least-Squares Mean Difference|-3.0|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-3.5|-2.4|||ANCOVA||||
1691540|NCT01106651|3109998|Superiority or Other||Least-Squares Mean Difference|-2.3|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-2.8|-1.7|||ANCOVA||||
1691541|NCT01106651|3109999|Superiority or Other||Least-Squares Mean Difference|-27.7|Standard Error of the Mean|3.179|<|0.001|2-Sided|95.0|-33.97|-21.49|||ANCOVA||||
1691542|NCT01106651|3109999|Superiority or Other||Least-Squares Mean Difference|-25.5|Standard Error of the Mean|3.147|<|0.001|2-Sided|95.0|-31.68|-19.32|||ANCOVA||||
1691543|NCT01106651|3110000|Superiority or Other||Odds Ratio (OR)|4.48|||<|0.001||95.0|2.89|6.95|||Regression, Logistic||||
1691544|NCT01106651|3110000|Superiority or Other||Odds Ratio (OR)|2.96|||<|0.001||95.0|1.93|4.56|||Regression, Logistic||||
1691545|NCT01106651|3110001|Superiority or Other||Least-Squares Mean Difference|-0.7|Standard Error of the Mean|0.07|<|0.001|2-Sided|95.0|-0.841|-0.566|||ANCOVA||||
1691546|NCT01106651|3110001|Superiority or Other||Least-Squares Mean Difference|-0.57|Standard Error of the Mean|0.069|<|0.001|2-Sided|95.0|-0.708|-0.436|||ANCOVA||||
1691547|NCT01106625|3110002|Superiority or Other||Least-Squares Mean Difference|3.4|Standard Error of the Mean|1.8||0.056|2-Sided|95.0|-0.1|6.8|||ANCOVA||||
1691548|NCT01106625|3110002|Superiority or Other||Least-Squares Mean Difference|2.5|Standard Error of the Mean|1.7||0.153|2-Sided|95.0|-0.9|5.9|||ANCOVA||||
1691549|NCT01106625|3110003|Superiority or Other||Least-Squares Mean Difference|-3.1|Standard Error of the Mean|5.5||0.571|2-Sided|95.0|-13.8|7.6|||ANCOVA||||
1691550|NCT01106625|3110003|Superiority or Other||Least-Squares Mean Difference|-6.2|Standard Error of the Mean|5.4||0.256|2-Sided|95.0|-16.9|4.5|||ANCOVA||||
1691551|NCT01106625|3110004|Superiority or Other||Least-Squares Mean Difference|-1.62|Standard Error of the Mean|1.266||0.201|2-Sided|95.0|-4.111|0.866|||ANCOVA||||
1691552|NCT01106625|3110004|Superiority or Other||Least-Squares Mean Difference|-2.24|Standard Error of the Mean|1.262||0.077|2-Sided|95.0|-4.719|0.241|||ANCOVA||||
1691553|NCT01106625|3110005|Superiority or Other||Least-Squares Mean Difference|-2.0|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-2.7|-1.3|||ANCOVA||||
1691554|NCT01106625|3110005|Superiority or Other||Least-Squares Mean Difference|-1.4|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-2.1|-0.7|||ANCOVA||||
1691555|NCT01106625|3110006|Superiority or Other||Least-Squares Mean Difference|-34.6|Standard Error of the Mean|4.692|<|0.001|2-Sided|95.0|-43.86|-25.42|||ANCOVA||||
1691556|NCT01106625|3110006|Superiority or Other||Least-Squares Mean Difference|-22.3|Standard Error of the Mean|4.627|<|0.001|2-Sided|95.0|-31.53|-13.16|||ANCOVA||||
1691557|NCT01106625|3110007|Superiority or Other||Odds Ratio (OR)|8.8|||<|0.001|2-Sided|95.0|4.86|15.95|||Regression, Logistic||||
1691558|NCT01106625|3110007|Superiority or Other||Odds Ratio (OR)|4.42|||<|0.001|2-Sided|95.0|2.48|7.87|||Regression, Logistic||||
1691559|NCT01106625|3110008|Superiority or Other||Least-Squares Mean Difference|-0.92|Standard Error of the Mean|0.097|<|0.001|2-Sided|95.0|-1.114|-0.732|||ANCOVA||||
1691560|NCT01106625|3110008|Superiority or Other||Least-Squares Mean Difference|-0.71|Standard Error of the Mean|0.097|<|0.001|2-Sided|95.0|-0.904|-0.524|||ANCOVA||||
1691561|NCT01106586|3110015|Non-Inferiority or Equivalence|A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA < 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.|Difference in response rates|3.0|||||2-Sided|95.2|-1.9|7.8|||||To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or > 100,000 copies/mL).|The null hypothesis was that the Stribild group is at least 12% worse than the ATV/r + Truvada group with respect to percentage of participants achieving HIV-1 RNA < 50 copies/mL (response rate as defined by the snapshot analysis algorithm) at Week 48; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the ATV/r + Truvada Group.|
1691564|NCT01106430|3110032|Superiority or Other||Mean Difference (Final Values)|18.1||||0.001|2-Sided|95.0|7.5|28.7|||Cochran-Mantel-Haenszel||||
1691565|NCT01106430|3110033|Superiority or Other||||||=|0|||||||Peto-Peto-Prentice Wilcoxon Test||||
1691566|NCT01106404|3110034|Superiority or Other||Mean Difference (Final Values)|1.5|Standard Deviation|2.04|<|0.001|2-Sided|95.0|||||Wilcoxon signed rank test||||
1691567|NCT01106404|3110034|Superiority or Other||Mean Difference (Final Values)|1.77|Standard Deviation|1.93|<|0.001||95.0|||||Wilcoxon signed rank test||||
1691568|NCT01106404|3110035|Superiority or Other||Mean Difference (Final Values)|14.8|Standard Deviation|51.9|<|0.001||95.0|||||Wilcoxon signed rank test||||
1691569|NCT01106404|3110036|Superiority or Other||binomial proportion|0.028|||||2-Sided|95.0|0.003|0.098|||||The combined percentage of subjects with worsened pain relief was reported.||
1691570|NCT01106404|3110037|Superiority or Other||binomial proportion|0.901|||<|0.001|1-Sided|97.5|0.807||||Fisher Exact||In this completed case analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.|Completed case analysis|
1691571|NCT01106404|3110037|Superiority or Other||binomial proportion|0.865|||<|0.001|1-Sided|97.5|0.765||||Fisher Exact||In this ITT analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.|"ITT analysis:~Hypothesis: The percentage of subjects who succeed must be greater than 25%. H0: p ≤ 0.25 HA: p > 0.25"|
1691572|NCT01106391|3110038|Superiority or Other||Rate of achieved primary safety(%)|97.0|||||2-Sided|95.0|88.0|100.0|||||The 95% confidence interval was based on the exact confidence interval (Collett, 1991)|Since this was a feasibility study without comparisons, sample size was not determined based on statistical consideration. No formal hypothesis testing was performed either.|
1691573|NCT01106391|3110039|Superiority or Other||Rate of technical success (%)|90.0|||||2-Sided|95.0|80.0|96.0|||||The 95% confidence interval was based on the exact confidence interval (Collett, 1991)|Since this was a feasibility study without comparisons, sample size was not determined based on statistical consideration. No formal hypothesis testing was performed either.|
1691574|NCT01106157|3110071|Superiority or Other||Median Difference (Final Values)|-7.67|Standard Error of the Mean|5.33||0.163|2-Sided|95.0|-18.7|3.35|||t-test, 2 sided||||
1691575|NCT01106157|3110072|Superiority or Other||Mean Difference (Net)|0.037|Standard Error of the Mean|0.1||0.79|2-Sided|95.0|-0.18|0.23|||t-test, 2 sided||||
1691576|NCT01106157|3110073|Superiority or Other||Mean Difference (Net)|-24.13|Standard Error of the Mean|19.61||0.23|2-Sided|95.0|-64.8|16.7|||t-test, 2 sided||||
1691577|NCT01106157|3110074|Superiority or Other||Mean Difference (Net)|0.28|Standard Error of the Mean|0.21||0.2|2-Sided|95.0|-0.15|0.7|||t-test, 2 sided||||
1691578|NCT01106157|3110075|Superiority or Other||Mean Difference (Net)|11.75|Standard Error of the Mean|81.3||0.89|2-Sided|95.0|-156.8|180.3|||t-test, 2 sided||||
1691579|NCT01106157|3110076|Superiority or Other||Mean Difference (Net)|-0.064|Standard Error of the Mean|0.16||0.69|2-Sided|95.0|-0.4|0.27|||t-test, 2 sided||||
1691580|NCT01106157|3110077|Superiority or Other||Mean Difference (Net)|-0.51|Standard Error of the Mean|0.7||0.37|2-Sided|95.0|-1.64|0.63|||t-test, 2 sided||||
1691581|NCT01106157|3110078|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.104||0.43|2-Sided|95.0|-0.3|0.13|||t-test, 2 sided||||
1691582|NCT01106157|3110079|Superiority or Other||Mean Difference (Net)|0.277|Standard Error of the Mean|0.134||0.017|2-Sided|95.0|0.001|0.552|||t-test, 2 sided||||
1691583|NCT01106092|3110097|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.|
1691584|NCT01106092|3110097|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|1.28|||||2-Sided|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.|
1691585|NCT01106092|3110097|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 3 is ≥ 2.|Difference in seroprotection rate|1.28|||||2-Sided|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.|
1691599|NCT01105975|3110117|Superiority or Other||Mean Difference (Final Values)|-39.8|||<|0.001|2-Sided|90.0|-47.0|-32.7|||mixed model repeated measures (MMRM)||||
1691600|NCT01105975|3110117|Superiority or Other||Mean Difference (Final Values)|-26.2|||<|0.001|2-Sided|90.0|-33.2|-19.2|||mixed model repeated measures (MMRM)||||
1691635|NCT01103414|3110416|Superiority or Other||Median Difference (Net)|-0.98|Standard Error of the Mean|0.169|<|0.0001|2-Sided|95.0|-1.32|-0.65|||ANCOVA||||
1691586|NCT01106092|3110097|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.|
1691587|NCT01106092|3110097|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.|
1691588|NCT01106092|3110097|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 2 is ≥ 2.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-4.78|4.78||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.|
1691589|NCT01106092|3110097|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.|
1691590|NCT01106092|3110097|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|1.28|||||2-Sided|95.0|-3.53|6.94||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.|
1691591|NCT01106092|3110097|Non-Inferiority|Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1] difference in percentage of seroprotected subjects ≤ 10%. The lower limit of the asymptotic 95% CI on the geometric mean of the individual ratios (post- over pre-booster titres) for anti-poliovirus type 1 is ≥ 2.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-4.78|4.72||||||To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix™/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.|
1691592|NCT01106014|3110101|Non-Inferiority or Equivalence|It was assumed that the probabilities for absence of worsening in WHO FC at Week 26 were the same for both treatment groups|Odds Ratio, log|1.161||||0.2843|2-Sided|99.0|0.811|1.664||Cochran-Mantel-Haenszel test stratified by WHO FC at baseline. For patients with missing NYHA/WHO FC at Week 26, the NYHA/WHO FC is considered as having worsened from baseline at Week 26. Missing values were imputed for 18.3% of subjects .|Cochran-Mantel-Haenszel||||
1691593|NCT01106014|3110102|Superiority or Other||Median Difference (Final Values)|12.0||||0.0027|2-Sided|99.0|1.0|24.0||One-sided p-value of the nonparametric ANCOVA, adjusted for 6-minute walk distance at baseline|ANCOVA||Point estimate and 2-sided 99% CI for location shift using the HodgesLehmann method|Non-parametric ANCOVA with 6MWD as covariate at baseline. Missing values were imputed based on the following imputation rules: 1) if patient was unable to walk at week 26, 0 meter was imputed, 2) if rule 1 did not apply, the second lowest observed 6MWD value (10 meters) at Week 26 was imputed. Missing values were imputed for 21.6% of the subjects.|
1691594|NCT01106014|3110103|Superiority or Other||Hazard Ratio (HR)|0.6|||<|0.0001|2-Sided|99.0|0.46|0.78||one-sided p-value|Log Rank|||The primary analysis was performed on the Full Analysis Set by a one-sided unstratified log-rank test|
1691595|NCT01105975|3110115|Superiority or Other||Mean Difference (Final Values)|-13.5||||0.002|2-Sided|90.0|-20.6|-6.4|||mixed model repeated measures (MMRM)||||
1691596|NCT01105975|3110115|Superiority or Other||Mean Difference (Final Values)|-11.2||||0.009|2-Sided|90.0|-18.3|-4.2|||mixed model repeated measures (MMRM)||||
1691597|NCT01105975|3110116|Superiority or Other||Mean Difference (Final Values)|88.5|||<|0.001|2-Sided|90.0|75.2|101.8|||mixed model repeated measures (MMRM)||||
1691598|NCT01105975|3110116|Superiority or Other||Mean Difference (Final Values)|79.3|||<|0.001||90.0|66.2|92.4|||mixed model repeated measures (MMRM)||||
1691601|NCT01105975|3110117|Superiority or Other||Mean Difference (Final Values)|-17.6|||<|0.001|2-Sided|90.0|-24.6|-10.5|||mixed model repeated measures (MMRM)||||
1691602|NCT01105975|3110118|Superiority or Other||Mean Difference (Final Values)|131.9|||<|0.001|2-Sided|90.0|118.5|145.2|||mixed model repeated measures (MMRM)||||
1691603|NCT01105975|3110118|Superiority or Other||Mean Difference (Final Values)|97.6|||<|0.001||90.0|84.5|110.8|||mixed model repeated measures (MMRM)||||
1691604|NCT01105975|3110118|Superiority or Other||Mean Difference (Final Values)|56.7|||<|0.001|2-Sided|90.0|43.6|69.8|||mixed model repeated measures (MMRM)||||
1691605|NCT01105975|3110119|Superiority or Other||Mean Difference (Final Values)|-13.9||||0.002|2-Sided|90.0|-21.2|-6.7|||mixed model repeated measures (MMRM)||||
1691606|NCT01105975|3110120|Superiority or Other||Mean Difference (Final Values)|78.5|||<|0.001|2-Sided|90.0|64.9|92.1|||mixed model repeated measures (MMRM)||||
1691607|NCT01105065|3110183|Superiority or Other|||||||0.28|||||||paired t-test|||A paired t-test was used to determine if their was a statistically significant difference between the mean deviation of the frequency doubling perimetry in the RVD patients pre and post brimonidine treatment.|
1691608|NCT01105065|3110184|Superiority or Other||||||<|0.0001|||||||Chi-squared, Corrected|||There would be no change in retinal vascular dysregulation after treatment with brimonidine|
1691609|NCT01104870|3110192|Superiority or Other|||||||0.27||||||Primary comparisons are between Dose Group 1 & Dose Group 3 and Dose Group 1 & Dose Group 2. The study is not powered to test for a difference between Dose Group 2 & Dose Group 3.|Wilcoxon (Mann-Whitney)|||Peak total pulmonary resistance index (TPRI) is defined as the TPRI value observed during exercise at the highest matching wattage achieved at both Baseline and Week 12. Where peak wattage cannot be matched, the closest higher wattage will be chosen for comparison.|
1691610|NCT01104870|3110192|Superiority or Other|||||||0.95||||||Primary comparisons are between Dose Group 1 & Dose Group 3 and Dose Group 1 & Dose Group 2. The study is not powered to test for a difference between Dose Group 2 & Dose Group 3.|Wilcoxon (Mann-Whitney)|||Peak total pulmonary resistance index (TPRI) is defined as the TPRI value observed during exercise at the highest matching wattage achieved at both Baseline and Week 12. Where peak wattage cannot be matched, the closest higher wattage will be chosen for comparison.|
1691611|NCT01104779|3110195|Superiority||Mean Difference (Final Values)|-0.5|||<|0.0001|2-Sided|95.0|-0.8|-0.3|||ANCOVA||Cariprazine 6-9 mg/day vs Placebo||
1691612|NCT01104779|3110195|Superiority||Mean Difference (Final Values)|-0.3|||<|0.0115|2-Sided|95.0|-0.6|-0.1|||ANCOVA||Cariprazine 3-6 mg/day vs Placebo||
1691613|NCT01104779|3110196|Superiority||Mean Difference (Final Values)|-9.9|||<|0.0001|2-Sided|95.0|-14.5|-5.3|||ANCOVA||Cariprazine 6-9 mg/day vs Placebo||
1691614|NCT01104779|3110196|Superiority||Mean Difference (Final Values)|-6.8|||<|0.0029|2-Sided|95.0|-11.3|-2.4|||ANCOVA||Cariprazine 3-6 mg/day vs Placebo||
1691615|NCT01104766|3110197|Superiority||Median Difference (Final Values)|-0.4||||0.0001|2-Sided|95.0|-0.6|-0.2|||ANCOVA||||
1691616|NCT01104766|3110197|Superiority||Median Difference (Final Values)|-0.5|||<|0.0001|2-Sided|95.0|-0.7|-0.3|||ANCOVA||||
1691617|NCT01104766|3110197|Superiority||Mean Difference (Final Values)|-0.4|||<|0.0004|2-Sided|95.0|-0.6|-0.2|||ANCOVA||||
1691618|NCT01104766|3110198|Superiority||Median Difference (Final Values)|-7.0||||0.0008|2-Sided|95.0|-11.0|-2.9|||ANCOVA||||
1691619|NCT01104766|3110198|Superiority||Mean Difference (Final Values)|-8.8|||<|0.0001|2-Sided|95.0|-12.9|-4.7|||ANCOVA||||
1691620|NCT01104766|3110198|Superiority||Mean Difference (Final Values)|-6.0|||<|0.0044|2-Sided|95.0|-10.1|-1.9|||ANCOVA||||
1691621|NCT01104545|3110289|Other||GMR|0.73|||||||||||||GMR = Fed/fasted||
1691622|NCT01104545|3110290|Other||Geometric mean ratio (GMR)|1.0|||||||||||||GMR = Fed/Fasted||
1691623|NCT01104493|3110315|Non-Inferiority or Equivalence|H0 (null): Rate difference ≥ 5 percentage points This corresponded to a null hypothesis of: HA (alternative): rate difference < 5 percentage points.|rate difference|0.4|||||2-Sided|95.0|-5.2|2.6||||||Comparison of the rate of fever between the 2 treatment groups was based on the upper limit of the two-sided 95% exact confidence intervals (CIs) for the rate increase (Monovalent vaccine minus Placebo) evaluated against the prespecified equivalence criterion of 5 percentage points.|
1691624|NCT01104155|3110349|Superiority or Other (legacy)|||||||0.041|||||||1-sided exact binomial||||
1691625|NCT01104155|3110349|Superiority or Other (legacy)|||||||0.204|||||||1-sided exact binomial|Based on a one-sided exact binomial test compared to 9%.|||
1691626|NCT01103960|3110363|Superiority or Other||Mean Difference (Final Values)|4.4879|Standard Error of the Mean|1.1217|<|0.001||95.0|2.2807|6.695|||ANCOVA|||A5 minus T80/A5|
1691627|NCT01103960|3110364|Superiority or Other||Mean Difference (Final Values)|1.9195|Standard Error of the Mean|0.9015||0.034||95.0|0.1443|3.6947||This was the second step in the closed testing procedure of multiple endpoints. The p-value was again <0.05 so this test was also considered confirmatory.|ANCOVA|||A5 minus T80/A5|
1691628|NCT01103960|3110365|Superiority or Other||Mean Difference (Final Values)|2.1881|Standard Error of the Mean|0.803||0.007||95.0|0.6082|3.7681||This was the first step in the closed testing procedure of multiple endpoints. The p-value was <0.05 so this test was considered confirmatory. Proceeding to the next step was allowed, testing the same endpoint in the subgroup of Chinese patients.|ANCOVA|||A5 minus T80/A5|
1691629|NCT01103934|3110366|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)||||
1691630|NCT01103934|3110367|Superiority or Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)||||
1691631|NCT01103479|3110400|Superiority or Other||Risk Ratio (RR)|1.05||||0.38|2-Sided|95.0|0.94|1.18||Linear model adjusting for stratification by clinic and participant age|Mixed Models Analysis||||
1691632|NCT01103479|3110401|Superiority or Other||Risk Ratio (RR)|1.43||||0.42|2-Sided|95.0|0.6|3.43||Random effects model adjusted for clustering by clinic|Mixed Models Analysis||||
1691633|NCT01103479|3110402|Superiority or Other||Risk Ratio (RR)|0.8||||0.28|2-Sided|95.0|0.53|1.2||Linear model adjusting for stratification by clinic and participant age|Mixed Models Analysis||||
1691634|NCT01103479|3110403|Superiority or Other||Risk Ratio (RR)|1.65||||0.32|2-Sided|95.0|0.62|4.38||Random effects model adjusting for clustering by clinic|Mixed Models Analysis||||
1692528|NCT01089556|3112100|Superiority or Other||LS Mean Difference (Final Values)|3.317|||<|0.001||95.0|||||ANCOVA||||
1691636|NCT01103414|3110416|Superiority or Other||Mean Difference (Net)|-0.86|Standard Error of the Mean|0.176|<|0.0001|2-Sided|95.0|-1.21|-0.52|||ANCOVA||||
1691637|NCT01103414|3110416|Superiority or Other||Mean Difference (Net)|-0.79|Standard Error of the Mean|0.171|<|0.0001|2-Sided|95.0|-1.13|-0.45|||ANCOVA||||
1691638|NCT01103414|3110416|Superiority or Other||Mean Difference (Net)|-0.39|Standard Error of the Mean|0.175|<|0.0273|2-Sided|95.0|-0.73|-0.04|||ANCOVA||||
1691639|NCT01103414|3110417|Superiority or Other||Mean Difference (Net)|-31.0|Standard Error of the Mean|6.5|<|0.0001|2-Sided|95.0|-43.8|-18.2|||ANCOVA||||
1691640|NCT01103414|3110417|Superiority or Other||Mean Difference (Net)|-28.9|Standard Error of the Mean|6.8|<|0.0001|2-Sided|95.0|-42.3|-15.6|||ANCOVA||||
1691641|NCT01103414|3110417|Superiority or Other||Mean Difference (Net)|-18.4|Standard Error of the Mean|6.59|<|0.0057|2-Sided|95.0|-31.4|-5.4|||ANCOVA||||
1691642|NCT01103414|3110417|Superiority or Other||Mean Difference (Net)|-9.1|Standard Error of the Mean|6.77|<|0.1819|2-Sided|95.0|-22.4|4.3|||ANCOVA||||
1691643|NCT01103323|3110420|Superiority or Other||Difference|-25.94|||<|1e-06||95.0|-32.06|-19.82||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Cochran-Mantel-Haenszel||Difference = Placebo - Regorafenib 160 mg|Two treatment groups compared using Cochran-Mantel-Haenszel (CMH) test adjusting for same stratification factors as at randomization.|
1691644|NCT01103323|3110421|Superiority or Other||Difference|-0.6||||0.188432||95.0|-1.74|0.53||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Cochran-Mantel-Haenszel||Difference = Placebo - Regorafenib 160 mg|Two treatment groups compared using Cochran-Mantel-Haenszel (CMH) test adjusting for same stratification factors as at randomization.|
1691645|NCT01103323|3110422|Superiority or Other||Hazard Ratio (HR)|0.494|||<|1e-06||95.0|0.419|0.582||Comparison based on pre-specified alpha level of 0.025 (1-sided).|Log Rank||Hazard ratio (Regorafenib / Placebo)|Two treatment groups compared using a stratified log-rank test, stratified by same stratification factors as randomization. Hazard ratio (Regorafenib / Placebo) and its 95% confidence interval calculated using Cox model, stratified by same factors.|
1691646|NCT01103323|3110423|Superiority or Other||Hazard Ratio (HR)|0.774||||0.005178||95.0|0.636|0.942||According to protocol specified O'Brien-Fleming type alpha spending function and 432 death events at 2nd IA, the pre-specified alpha (false positive rate) for this analysis was 0.009279 (1-sided).|Log Rank||Two treatment groups compared using a stratified log-rank test, stratified by same stratification factors as randomization. Hazard ratio (Regorafenib / Placebo) and its 95% confidence interval calculated using Cox model, stratified by same factors.|Sample size based on primary efficacy endpoint of OS. The study was designed to have 90% power to detect 33.3% increase in median OS (i.e. hazard ratio of 0.75, Regorafenib / Placebo). Assuming 1-sided overall alpha of 0.025, randomization ratio of 2:1 for Regorafenib and Placebo, and 2 formal interim analyses of OS using an O’Brien-Fleming-type error spending function, a total of 582 death events were required for primary completion. Results based on 2nd planned formal IA with 432 total events.|
1691647|NCT01103284|3110424|Superiority or Other||Hazard Ratio (HR)|0.38||||0.07|2-Sided|95.0|-0.02|0.79||Standard multiple imputation was used to predict the number and timing of hypoglycemic events after discontinuing the study for subjects who did not remain in the study until Month 25.|negative binomial regression|||The number of hypoglycemia events during the study was analyzed using a negative binomial regression model, with number of events as the dependent variable, and treatment, age, baseline daily insulin dose, and baseline C-peptide as covariates. The log of duration in the study for each patient was used as an offset variable in the model.|
1691648|NCT01103284|3110426|Superiority or Other|||||||0.44||||||The a priori threshold for statistical significance was 0.05|Mixed Models Analysis|The MMRM model was adjusted for the following covariates: age, Baseline C-peptide, Baseline insulin dose adjusted for body weight, and Baseline AUC|||
1691649|NCT01103284|3110427|Superiority or Other|||||||0.68||||||A priori threshold for statistical significance was 0.05|Mixed Models Analysis|The MMRM model was adjusted for the following covariates: age, Baseline C-peptide, Baseline insulin dose adjusted for body weight, and Baseline AUC.|||
1691650|NCT01103284|3110428|Superiority or Other|||||||0.33||||||The a priori threshold for statistical significance was 0.05|Mixed Models Analysis|The Mixed-Effect Model Repeated Measure (MMRM) was adjusted for the following baseline covariates: age, C-peptide, insulin dose by body weight and AUC|||
1691651|NCT01103063|3110437|Superiority or Other||Mean Difference (Final Values)|0.0||||1|2-Sided||||||Fisher Exact|||Statistical analysis for Visit 7 presented above.|
1691652|NCT01103063|3110437|Superiority or Other||Mean Difference (Final Values)|0.0||||1|2-Sided||||||Fisher Exact|||Statistical analysis for Visit 6 presented above.|
1691653|NCT01103063|3110438|Superiority or Other||Mean Difference (Final Values)|0.0||||1|2-Sided||||||Fisher Exact|||Statistical analysis for Visit 7 presented above.|
1691654|NCT01103063|3110438|Superiority or Other||Mean Difference (Final Values)|-11.76||||1|2-Sided||||||Fisher Exact|||Statistical analysis for Visit 6 presented above.|
1691655|NCT01103063|3110439|Superiority or Other||Risk Ratio (RR)|0.61|Standard Deviation|0.4195||0.2321|2-Sided|95.0|0.27|1.38||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691656|NCT01103063|3110440|Superiority or Other||Risk Ratio (RR)|0.39|Standard Deviation|0.4439||0.0332|2-Sided|95.0|0.16|0.93||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691657|NCT01103063|3110441|Superiority or Other||Risk Ratio (RR)|2.09|Standard Deviation|0.8648||0.3942|2-Sided|95.0|0.38|11.38||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691658|NCT01103063|3110442|Superiority or Other||Risk Ratio (RR)|0.73|Standard Deviation|0.1536||0.0384|2-Sided|95.0|0.54|0.98||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691659|NCT01103063|3110443|Superiority or Other||Risk Ratio (RR)|0.77|Standard Deviation|0.1336||0.0527|2-Sided|95.0|0.59|1.0||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691660|NCT01103063|3110444|Superiority or Other||Risk Ratio (RR)|0.46|Standard Deviation|0.3291||0.0188|2-Sided|95.0|0.24|0.88||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691661|NCT01103063|3110445|Superiority or Other||Risk Ratio (RR)|0.25|Standard Deviation|0.6386||0.0284|2-Sided|95.0|0.07|0.86||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691662|NCT01103063|3110446|Superiority or Other||Risk Ratio (RR)|2.34|Standard Deviation|0.5338||0.1113|2-Sided|95.0|0.82|6.66||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691663|NCT01103063|3110447|Superiority or Other||Risk Ratio (RR)|0.75|Standard Deviation|0.0918||0.0016|2-Sided|95.0|0.62|0.9||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691664|NCT01103063|3110448|Superiority or Other||Risk Ratio (RR)|0.66|Standard Deviation|0.5675||0.4655|2-Sided|95.0|0.22|2.01||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691665|NCT01103063|3110449|Superiority or Other||Risk Ratio (RR)|0.81|Standard Deviation|0.163||0.1975|2-Sided|95.0|0.59|1.12||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691666|NCT01103063|3110450|Superiority or Other||Risk Ratio (RR)|0.62|Standard Deviation|0.2295||0.036|2-Sided|95.0|0.39|0.97||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691667|NCT01103063|3110451|Superiority or Other||Risk Ratio (RR)|0.49|Standard Deviation|0.1221|<|0.0001|2-Sided|95.0|0.38|0.62||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691668|NCT01103063|3110452|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.01|<|0.0001|2-Sided|95.0|-0.09|-0.04||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of symptomatic malaria).|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.|
1691669|NCT01103063|3110453|Superiority or Other||Mean Difference (Final Values)|2.1|Standard Error of the Mean|19.71||0.9145|2-Sided|95.0|-36.5|40.8||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable.|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.|
1691670|NCT01103063|3110454|Superiority or Other||Risk Ratio (RR)|1.14|Standard Deviation|0.2908||0.6542|2-Sided|95.0|0.64|2.01||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691684|NCT01102777|3110498|Superiority or Other|||||||0.01|||||||Mixed Models Analysis|Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.|||
1691671|NCT01103063|3110455|Superiority or Other||Risk Ratio (RR)|0.9|Standard Deviation|0.2694||0.6978|2-Sided|95.0|0.53|1.53||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691672|NCT01103063|3110456|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.05||0.0131|2-Sided|95.0|-0.24|-0.03||Analysis based on an ANCOVA model with model terms for baseline value, treatment group and randomization stratification variable.|ANCOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.|
1691673|NCT01103063|3110457|Superiority or Other||Risk Ratio (RR)|1.08|Standard Deviation|0.0604||0.2265|2-Sided|95.0|0.96|1.21||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691674|NCT01103063|3110458|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.02||0.0011|2-Sided|95.0|-0.08|-0.02||Analysis based on an ANOVA model with model terms for treatment group and randomization stratification variable. A negative mean difference between treatment groups favors Azithromycin + Chloroquine (reduction in number of STIs).|ANOVA|||The 2-sided P-value tests the null hypothesis that the mean difference is 0 (treatment group equality) versus not equal 0.|
1691675|NCT01103063|3110459|Superiority or Other||Risk Ratio (RR)|0.84|Standard Deviation|0.1842||0.3468|2-Sided|95.0|0.59|1.21||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691676|NCT01103063|3110460|Superiority or Other||Risk Ratio (RR)|0.93|Standard Deviation|0.1817||0.7105|2-Sided|95.0|0.65|1.33||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691677|NCT01103063|3110461|Superiority or Other||Risk Ratio (RR)|1.03|Standard Deviation|0.04||0.4605|2-Sided|95.0|0.95|1.11||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691678|NCT01103063|3110462|Superiority or Other||Risk Ratio (RR)|0.9|Standard Deviation|0.2866||0.7035|2-Sided|95.0|0.51|1.57||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691679|NCT01103063|3110463|Superiority or Other||Risk Ratio (RR)|0.91|Standard Deviation|0.1882||0.6086|2-Sided|95.0|0.63|1.31||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691680|NCT01103063|3110464|Superiority or Other||Risk Ratio (RR)|0.87|Standard Deviation|0.1745||0.4428|2-Sided|95.0|0.62|1.23||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint).|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691681|NCT01103063|3110465|Superiority or Other||Risk Ratio (RR)|1.03|Standard Deviation|0.1243||0.84117|2-Sided|95.0|0.8|1.31||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint)|Mantel Haenszel||The estimated risk ratio is presented along with its SE, with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691682|NCT01103063|3110466|Superiority or Other||Risk Ratio (RR)|1.11|Standard Deviation|0.0647||0.12237|2-Sided|95.0|0.97|1.25||Mantel-Haenszel estimate of the common relative risk is presented, adjusting for randomization strata. A relative risk less than 1 favors Azithromycin + Chloroquine treatment group (reduction in risk for the endpoint)|Mantel Haenszel||The estimated risk ratio is presented along with its standard error (SE), with the SE on the log(e) scale.|The 2-sided P-value tests the null hypothesis that the relative risk equals 1 (treatment group equality) versus not equal 1.|
1691683|NCT01102972|3110490|Non-Inferiority or Equivalence|Non-inferiority would be established between the two arms if the lower limit of the 2-sided 95% confidence interval (CI) for the difference in the percentage of participants with HIV-1 RNA <50 copies/mL at Week 24 was -12% or greater.|Treatment difference of proportions|0.33||||0.937||95.0|-7.97|8.64||The p-value was obtained from the Cochran-Mantel-Haenszel method stratified by initial antiretroviral regimen.|Cochran-Mantel-Haenszel||95% confidence intervals were calculated (using Mantel-Haenszel weight) stratified by initial antiretroviral regimen.||
1696410|NCT01033942|3118851|Superiority or Other|||||||0.4906|||||||Fisher Exact||||
1691685|NCT01102777|3110499|Superiority or Other|||||||0.11|||||||Regression, Linear|Adjusting for time, MMRC score, and urban versus rural residence.|||
1691686|NCT01102777|3110500|Superiority or Other||Mean Difference (Net)|0.0|||||2-Sided|||||||||The determination of arm occurred after recruitment, and Study Reach is a recruitment value.|
1691687|NCT01102777|3110501|Superiority or Other|||||||0.52|||||||Mixed Models Analysis|Based on mixed models, adjusting for time, MMRC score, and urban versus rural residence.|||
1691688|NCT01102777|3110502|Superiority or Other|||||||0.731|||||||Mixed Models Analysis|Based on mixed models, adjusting for group, time, group*time interaction, MMRC score, and urban versus rural residence.|||
1691689|NCT01102777|3110503|Superiority or Other|||||||0.08|||||||Zero inflated Poisson regression|Adjusted for age, gender, oxygen use, and arm.|||
1691690|NCT01102777|3110504|Superiority or Other|||||||0.93|||||||Regression, Linear|Adjusted for baseline value and rural residence.|||
1691691|NCT01102777|3110505|Superiority or Other|||||||0.9|||||||Regression, Linear|Adjusted for baseline value and rural residence.|||
1691692|NCT01102777|3110506|Superiority or Other|||||||0.502|||||||Mixed Models Analysis|Based on mixed models, adjusting for group, time, group*time interaction, MMRC score, and urban versus rural residence.|||
1691693|NCT01102777|3110507|Superiority or Other|||||||0.142|||||||Regression, Linear|Adjusted for baseline value of outcome, MMRC dyspnea score, and urban versus rural residence.|||
1691694|NCT01102491|3110521|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1691695|NCT01102257|3110543|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1691696|NCT01102218|3110553|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1691697|NCT01101841|3110572|Superiority or Other|||||||0.0064||||||Week 12 severity|Rank transformed ANCOVA||||
1691698|NCT01101841|3110572|Superiority or Other|||||||0.0368||||||Week 4 severity|Rank transformed ANCOVA||||
1691699|NCT01101841|3110587|Superiority or Other|||||||0.0066||||||Week 24 persistence of effect|Logit model||||
1691700|NCT01101841|3110588|Superiority or Other|||||||0.0001||||||Week 12 frequency|Rank transformed ANCOVA||||
1691701|NCT01101841|3110588|Superiority or Other||||||<|0.0001||||||Week 4 frequency|Rank transformed ANCOVA||||
1691702|NCT01101477|3110604|Superiority or Other|||||||0.05|||||||Chi-squared|||The patients with at lease one episode of hypoxemia (SPaO2<90%) during FB were analyzed by Chi-square test. P value less 0.05 means significance, 2-sided.|
1691703|NCT01101321|3110608|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.5|||||2-Sided|90.0|95.42|101.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691704|NCT01101321|3110609|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.5|||||2-Sided|90.0|95.44|101.73|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691705|NCT01101321|3110610|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||2-Sided|90.0|96.14|104.96|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691706|NCT01101308|3110611|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||2-Sided|90.0|97.14|102.99|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691707|NCT01101308|3110612|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|100.0|||||2-Sided|90.0|97.19|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691708|NCT01101308|3110613|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|102.0|||||2-Sided|90.0|97.51|107.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691709|NCT01101191|3110614|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|97.1|||||2-Sided|90.0|94.41|99.94|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691710|NCT01101191|3110615|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|97.0|||||2-Sided|90.0|94.2|99.81|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691711|NCT01101191|3110616|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|103.0|||||2-Sided|90.0|98.67|106.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691712|NCT01101178|3110617|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.9|||||2-Sided|90.0|92.9|97.02|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691713|NCT01101178|3110618|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.7|||||2-Sided|90.0|92.71|96.64|||||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.||
1691714|NCT01101178|3110619|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|110.0|||||2-Sided|90.0|105.21|114.47|||||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.||
1693862|NCT01068262|3115070|Superiority or Other||Mean Difference (Final Values)|69.2|||||2-Sided|90.0|50.9|80.2|||||||
1691715|NCT01101165|3110620|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|95.5|||||2-Sided|90.0|92.93|98.18|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691716|NCT01101165|3110621|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|94.8|||||2-Sided|90.0|92.42|97.24|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691717|NCT01101165|3110622|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|96.6|||||2-Sided|90.0|92.8|100.56|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691718|NCT01101035|3110639|Non-Inferiority|Noninferiority was declared if the upper 1-sided CI for the hazard ratio was less than 1.3. Critical boundary of 2.014 (final analysis) based on the Lan-DeMets-O’Brien-Fleming alpha spending function was used for CI estimation.|Cox Proportional Hazard|1.03|||||2-Sided|97.0|0.87|1.23|||||Time from randomization to the first occurrence of any MACE was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function as a stratification factor.|Statistical analysis for the primary endpoint was based on 1-sided repeated confidence intervals (CIs), using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%, to assess non-inferiority at each interim analysis and the final analysis.|
1691719|NCT01101035|3110640|Other||Cox Proportional Hazard|0.86|||||2-Sided|95.0|0.59|1.26|||||Time from randomization to the first occurrence of unstable angina with urgent coronary revascularization was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.||
1691720|NCT01101035|3110641|Other||Cox Proportional Hazard|1.01|||||2-Sided|95.0|0.73|1.41|||||Time from randomization to the first occurrence of non-fatal stroke was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.||
1691721|NCT01101035|3110642|Other||Cox Proportional Hazard|0.93|||||2-Sided|95.0|0.72|1.21|||||Time from randomization to the first occurrence of non-fatal MI was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.||
1691722|NCT01101035|3110643|Other||Cox Proportional Hazard|1.34|||||2-Sided|95.0|1.03|1.73|||||Time from randomization to the first occurrence of cardiovascular death was fitted using Cox Proportional Hazard model with factors including treatment and baseline renal function.||
1691723|NCT01101035|3110644|Other||Cox Proportional Hazard|1.09|||||2-Sided|95.0|0.92|1.28|||||Time from randomization to the first occurrence of any APTC event was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function status as a stratification factor.||
1691724|NCT01101035|3110645|Non-Inferiority|Noninferiority was declared if the upper 1-sided CI for the hazard ratio was less than 1.3. Critical boundary of 2.359 (75% interim) based on the Lan-DeMets-O’Brien-Fleming alpha spending function was used for CI estimation.|Cox Proportional Hazard|0.99|||||1-Sided|97.0||1.23|||||Time from randomization to the first occurrence of any MACE was fitted using Cox Proportional Hazard model with treatment as a covariate and Baseline renal function as a stratification factor.|Statistical analysis for the primary endpoint was based on 1-sided repeated confidence intervals (CIs), using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%, to assess non-inferiority at each interim analysis and the final analysis.|
1691725|NCT01101022|3110646|Superiority or Other||Mean Difference (Final Values)|14.7||||0.0015|2-Sided|95.0|5.9|23.6|||ANCOVA|||Total Score|
1691726|NCT01101022|3110646|Superiority or Other||Mean Difference (Final Values)|7.3||||0.1752|2-Sided|95.0|-3.4|18.0|||ANCOVA|||Relationships|
1691727|NCT01101022|3110646|Superiority or Other||Mean Difference (Final Values)|12.5||||0.0038|2-Sided|95.0|4.2|20.8|||ANCOVA|||Life Outlook|
1691728|NCT01101022|3110646|Superiority or Other||Mean Difference (Final Values)|12.1||||0.0242|2-Sided|95.0|1.6|22.5|||ANCOVA|||Psychological Health|
1691729|NCT01101022|3110646|Superiority or Other||Mean Difference (Final Values)|21.0||||0.0016|2-Sided|95.0|8.4|33.6|||ANCOVA|||Life Productivity|
1691730|NCT01101022|3110647|Superiority or Other||Mean Difference (Final Values)|-4.4||||0.0059|2-Sided|95.0|-7.5|-1.3|||ANCOVA|||Problems with Self-concept|
1691731|NCT01101022|3110647|Superiority or Other||Mean Difference (Final Values)|-4.0||||0.0063|2-Sided|95.0|-6.8|-1.1|||ANCOVA|||Impulsivity/Emotional Liability|
1691732|NCT01101022|3110647|Superiority or Other||Mean Difference (Final Values)|-4.1||||0.0174|2-Sided|95.0|-7.5|-0.7|||ANCOVA|||Hyperactivity/Restlessness|
1691733|NCT01101022|3110647|Superiority or Other||Mean Difference (Final Values)|-5.1||||0.0017|2-Sided|95.0|-8.2|-1.9|||ANCOVA|||Inattention/Memory Problems|
1691734|NCT01101022|3110648|Superiority or Other||Mean Difference (Final Values)|-5.5||||0.0019|2-Sided|95.0|-9.0|-2.1|||ANCOVA||||
1691735|NCT01101022|3110649|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.0004|2-Sided|95.0|-0.9|-0.3|||ANCOVA|||Question 4|
1691736|NCT01101022|3110649|Superiority or Other||Mean Difference (Final Values)|0.5||||0.0184|2-Sided|95.0|0.1|1.0|||ANCOVA|||Question 1|
1691737|NCT01101022|3110650|Superiority or Other||Mean Difference (Final Values)|10.8|||<|0.0001|2-Sided|95.0|6.0|15.5|||ANCOVA|||General Well-being|
1691738|NCT01101022|3110650|Superiority or Other||Mean Difference (Final Values)|9.1|||<|0.0001|2-Sided|95.0|5.4|12.7|||ANCOVA|||Living with ADHD|
1691739|NCT01101022|3110651|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1691740|NCT01101022|3110654|Superiority or Other||Mean Difference (Final Values)|-11.1|||<|0.0001|2-Sided|95.0|-14.9|-7.3|||ANCOVA||||
1691741|NCT01101022|3110655|Superiority or Other||Mean Difference (Final Values)|-3.2||||0.0234|2-Sided|95.0|-5.9|-0.4|||ANCOVA|||Organization of materials|
1691742|NCT01101022|3110655|Superiority or Other||Mean Difference (Final Values)|-6.3||||0.0003|2-Sided|95.0|-9.7|-2.9|||ANCOVA|||Task monitor|
1691743|NCT01101022|3110655|Superiority or Other||Mean Difference (Final Values)|-4.9||||0.0015|2-Sided|95.0|-7.9|-1.9|||ANCOVA|||Plan/Organize|
1691744|NCT01101022|3110655|Superiority or Other||Mean Difference (Final Values)|-6.3||||0.0004|2-Sided|95.0|-9.8|-2.9|||ANCOVA|||Working memory|
1691745|NCT01101022|3110655|Superiority or Other||Mean Difference (Final Values)|-5.5||||0.0002|2-Sided|95.0|-8.3|-2.7|||ANCOVA|||Initiate|
1691746|NCT01101022|3110655|Superiority or Other||Mean Difference (Final Values)|-2.2||||0.1468|2-Sided|95.0|-5.1|0.8|||ANCOVA|||Self-monitor|
1691747|NCT01101022|3110655|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.3605|2-Sided|95.0|-4.0|1.5|||ANCOVA|||Emotional control|
1691748|NCT01101022|3110655|Superiority or Other||Mean Difference (Final Values)|-4.8||||0.0045|2-Sided|95.0|-8.0|-1.5|||ANCOVA|||Shift|
1691749|NCT01101022|3110655|Superiority or Other||Mean Difference (Final Values)|-4.4||||0.0048|2-Sided|95.0|-7.4|-1.4|||ANCOVA|||Inhibit|
1691750|NCT01101022|3110656|Superiority or Other||Mean Difference (Final Values)|-8.9|||<|0.0001|2-Sided|95.0|-12.5|-5.3|||ANCOVA|||Organization of materials|
1691751|NCT01101022|3110656|Superiority or Other||Mean Difference (Final Values)|-9.3|||<|0.0001|2-Sided|95.0|-14.0|-4.7|||ANCOVA|||Task monitor|
1691752|NCT01101022|3110656|Superiority or Other||Mean Difference (Final Values)|-10.9|||<|0.0001|2-Sided|95.0|-15.4|-6.4|||ANCOVA|||Plan/Organize|
1691753|NCT01101022|3110656|Superiority or Other||Mean Difference (Final Values)|-11.3|||<|0.0001|2-Sided|95.0|-16.0|-6.6|||ANCOVA|||Working memory|
1691754|NCT01101022|3110656|Superiority or Other||Mean Difference (Final Values)|-9.3|||<|0.0001|2-Sided|95.0|-13.2|-5.4|||ANCOVA|||Initiate|
1691755|NCT01101022|3110656|Superiority or Other||Mean Difference (Final Values)|-8.2|||<|0.0001|2-Sided|95.0|-12.3|-4.1|||ANCOVA|||Sef-monitor|
1691756|NCT01101022|3110656|Superiority or Other||Mean Difference (Final Values)|-5.2|||<|0.0056|2-Sided|95.0|-8.8|-1.5|||ANCOVA|||Emotional control|
1691757|NCT01101022|3110656|Superiority or Other||Mean Difference (Final Values)|-6.7|||<|0.0018|2-Sided|95.0|-10.8|-2.5|||ANCOVA|||Shift|
1691758|NCT01101022|3110656|Superiority or Other||Mean Difference (Final Values)|-8.3|||<|0.0001|2-Sided|95.0|-12.6|-4.1|||ANCOVA|||Inhibit|
1691759|NCT01101022|3110657|Superiority or Other||Mean Difference (Final Values)|-11.6|||<|0.0001|2-Sided|95.0|-16.3|-7.0|||ANCOVA|||Metacognition Index|
1691760|NCT01101022|3110657|Superiority or Other||Mean Difference (Final Values)|-8.4|||<|0.0002|2-Sided|95.0|-12.7|-4.0|||ANCOVA|||Behavioral Regulation Index|
1691761|NCT01101022|3110658|Superiority or Other||Mean Difference (Final Values)|-5.7||||0.0003|2-Sided|95.0|-8.7|-2.7|||ANCOVA|||Metacognition Index|
1691762|NCT01101022|3110658|Superiority or Other||Mean Difference (Final Values)|-3.1||||0.0355|2-Sided|95.0|-6.0|-0.2|||ANCOVA|||Behavioral Regulation Index|
1691763|NCT01101022|3110658|Superiority or Other||Mean Difference (Final Values)|-4.9||||0.0016|2-Sided|95.0|-7.8|-1.9|||ANCOVA|||Global Executive Composite|
1691764|NCT01101022|3110659|Superiority or Other||Mean Difference (Final Values)|7.8||||0.0302|2-Sided|95.0|0.8|14.9|||ANCOVA|||Relationships/Communication|
1691765|NCT01101022|3110659|Superiority or Other||Mean Difference (Final Values)|13.5||||0.0003|2-Sided|95.0|6.3|20.7|||ANCOVA|||Bother/Concern|
1691766|NCT01101022|3110659|Superiority or Other||Mean Difference (Final Values)|14.9|||<|0.0001|2-Sided|95.0|7.8|22.0|||ANCOVA|||Daily Interference|
1691767|NCT01101022|3110659|Superiority or Other||Mean Difference (Final Values)|21.6|||<|0.0001|2-Sided|95.0|13.5|29.7|||ANCOVA|||Performance and Daily Functioning|
1691768|NCT01101022|3110660|Superiority or Other||Mean Difference (Final Values)|-11.2|||<|0.0001|2-Sided|95.0|-15.9|-6.4|||ANCOVA||||
1691769|NCT01100944|3110661|Superiority or Other|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test||||
1691770|NCT01100944|3110661|Superiority or Other|||||||0.0001||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test||||
1691771|NCT01100944|3110661|Superiority or Other|||||||0.95||||||Fold change at Cycle 2 Day 1 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test||||
1691772|NCT01100944|3110662|Superiority or Other|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test||||
1691773|NCT01100944|3110662|Superiority or Other|||||||0.0009||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test||||
1691774|NCT01100944|3110662|Superiority or Other|||||||0.76||||||Fold change at Cycle 2 Day 1 vs. pre was assessed.Only differences with p<0.005 could be potentially considered statistically significant while those with 0.005<p<0.05 would represent trends towards a difference.|Wilcoxon signed rank test||||
1691775|NCT01100944|3110663|Superiority or Other|||||||0.0001||||||Fold change at Cycle 1 Day 3 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test||||
1691776|NCT01100944|3110663|Superiority or Other|||||||0.0001||||||Fold change at Cycle 1 Day 2 vs. pre was assessed. p values calculated were done using a Wilcoxon signed rank test relative to a ratio of 1.|Wilcoxon signed rank test||||
1691777|NCT01100944|3110663|Superiority or Other|||||||0.3||||||Fold change at Cycle 2 Day 1 vs. pre was assessed. Only differences with p<0.005 could be potentially considered statistically significant while those with 0.005<p<0.05 would represent trends towards a difference.|Wilcoxon signed rank test||||
1691778|NCT01100944|3110672|Superiority or Other|||||||0.021|||||||Wilcoxon (Mann-Whitney)||||
1691779|NCT01100723|3110697|Superiority or Other||||||<|0.05|||||||McNemar|||Proportion of subjects on specified medications were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects on the specified medications was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.|
1694052|NCT01065454|3115343|Superiority or Other (legacy)||LS-MEANS Difference|-407.34|||||2-Sided|95.0|-1055.23|240.54|||||||
1691780|NCT01100723|3110698|Superiority or Other||||||<|0.05|||||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with Ca values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.|
1691781|NCT01100723|3110699|Superiority or Other||||||<|0.05|||||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.|
1691782|NCT01100723|3110700|Superiority or Other||||||<|0.05|||||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.|
1691783|NCT01100723|3110701|Superiority or Other||||||<|0.05|||||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with phosphorus values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.|
1691784|NCT01100723|3110702|Superiority or Other||||||<|0.05|||||||McNemar|||Number of subjects meeting targets were compared to the same subjects baseline values using the McNemar test for paired longitudinal data. For the 1 year analysis, the proportion of subjects with PTH values in the target range was calculated at 1 year and that was compared to the proportion of the same subjects who were in target at baseline.|
1691785|NCT01100502|3110723|Superiority or Other (legacy)||Hazard Ratio (HR)|0.57||||0.001|2-Sided|95.0|0.4|0.81|||Log Rank||||
1691786|NCT01100320|3110740|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|92.6|||||2-Sided|90.0|90.13|95.13|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691787|NCT01100320|3110741|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|92.6|||||2-Sided|90.0|90.11|95.09|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691788|NCT01100320|3110742|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|99.9|||||2-Sided|90.0|95.4|104.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691789|NCT01100307|3110759|Superiority or Other||Mean Difference (Final Values)|4.26|||<|0.0001|2-Sided|95.0|2.19|6.32||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 24: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.|
1691790|NCT01100307|3110759|Superiority or Other||Mean Difference (Final Values)|2.65|||<|0.0096|2-Sided|95.0|0.65|4.65||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 18: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.|
1691791|NCT01100307|3110759|Superiority or Other||Mean Difference (Final Values)|3.69|||<|0.0001|2-Sided|95.0|1.81|5.58||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 12: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.|
1691792|NCT01100307|3110759|Superiority or Other||Mean Difference (Final Values)|2.52|||<|0.0006|2-Sided|95.0|1.1|3.94||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|ANCOVA|Based on an analysis of covariance with treatment as a factor and stratification factors (HbA1c and baseline visual acuity categories) as covariates.||Comparison at Week 6: The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.|
1691793|NCT01100307|3110760|Superiority or Other||Odds Ratio (OR)|4.85||||0.0003|2-Sided|95.0|1.92|12.28||Significance level of test in the comparison between pegaptanib sodium 0.3 mg and sham was set to 0.05.|Cochran-Mantel-Haenszel|Stratification factors (HbA1c and baseline visual acuity categories)||The null hypothesis was to assume that there was no difference between the pegaptanib sodium and sham injection groups. The alternative was to assume that there was difference between the pegaptanib sodium and sham injection groups.|
1691794|NCT01100086|3110771|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|98.3|||||2-Sided|90.0|95.2|101.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691795|NCT01100086|3110771|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.3|||||2-Sided|90.0|95.2|101.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1692146|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-25.2|||<|0.0001|2-Sided|95.0|-36.1|-14.3|||Mixed Models Analysis|||1:15am|
1691796|NCT01100086|3110772|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|98.0|||||2-Sided|90.0|94.94|101.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691797|NCT01100086|3110773|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|102.0|||||2-Sided|90.0|99.35|105.42|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691798|NCT01099761|3110807|Superiority or Other|||||||0.039|||||||ANCOVA||||
1691799|NCT01099761|3110808|Superiority or Other|||||||0.435|||||||ANCOVA||||
1691800|NCT01099761|3110808|Superiority or Other|||||||0.012|||||||ANCOVA||||
1691801|NCT01099761|3110808|Superiority or Other|||||||0.023|||||||ANCOVA||||
1691802|NCT01099709|3110811|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric test/Ref Ratio x 100|95.7|||||2-Sided|90.0|93.85|97.68|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691803|NCT01099709|3110812|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|95.6|||||2-Sided|90.0|93.73|97.53|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691804|NCT01099709|3110813|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference)|Geometric Test/Ref Ratio x 100|105.0|||||2-Sided|90.0|101.06|108.51|||||Bioequivalence is established when 90% Confidence Interval falls within 80%-125%.||
1691805|NCT01099709|3110813|Non-Inferiority or Equivalence|A mixed-model analysis of variance was used to compare (test vs reference) and the 90% confidence intervals were estimated for the ratios (test/reference).|Geometric Test/Ref Ratio x 100|105.0|||||2-Sided|90.0|101.06|108.51|||||Bioequivalence was established when 90% Confidence Interval fell within 80%-125%.||
1691806|NCT01099449|3110840|Non-Inferiority or Equivalence|Chi-Squared Analysis||||||0.66|||||||Chi-squared||||
1691807|NCT01099449|3110840|Non-Inferiority or Equivalence|Chi-Squared Analysis||||||0.52|||||||Chi-squared||||
1691808|NCT01099449|3110841|Non-Inferiority or Equivalence|Kruskal Wallis Analysis||||||0.496|||||||Kruskal-Wallis||||
1691809|NCT01099449|3110841|Non-Inferiority or Equivalence|Kruskal Wallis Analysis||||||0.89|||||||Kruskal-Wallis||||
1691810|NCT01099449|3110844|Non-Inferiority or Equivalence|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in >> primary analysis.||||||0.25|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple >> comparisons among the numerous hypothesis testings of secondary endpoints due to the >> exploratory nature of these secondary analyses. The significance results from secondary >> analyses will be interpreted cautiously in a hypothesis-generating fashion.|
1691811|NCT01099449|3110844|Non-Inferiority or Equivalence|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in >> primary analysis.||||||0.29|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple >> comparisons among the numerous hypothesis testings of secondary endpoints due to the >> exploratory nature of these secondary analyses. The significance results from secondary >> analyses will be interpreted cautiously in a hypothesis-generating fashion.|
1691812|NCT01099449|3110845|Non-Inferiority or Equivalence|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in >> primary analysis.||||||0.27|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple >> comparisons among the numerous hypothesis testings of secondary endpoints due to the >> exploratory nature of these secondary analyses. The significance results from secondary >> analyses will be interpreted cautiously in a hypothesis-generating fashion.|
1691813|NCT01099449|3110845|Non-Inferiority or Equivalence|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in >> primary analysis.||||||0.054|||||||Wilcoxon (Mann-Whitney)|||We will not adjust p-values (or significance level) for multiple >> comparisons among the numerous hypothesis testings of secondary endpoints due to the >> exploratory nature of these secondary analyses. The significance results from secondary >> analyses will be interpreted cautiously in a hypothesis-generating fashion.|
1691814|NCT01099449|3110846|Non-Inferiority or Equivalence|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in >> primary analysis.||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Two-sample t-tests or Wilcoxon rank-sum tests will be used >> to compare the AUC of CIPN sensory subscale between each of the two schedules of >> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory >> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory >> subscale scores from the AUC or incorporate them as a covariate in generalized linear >> regression model.|
1691815|NCT01099449|3110846|Non-Inferiority or Equivalence|Two-sample t-tests or Wilcoxon rank-sum tests will be used as in >> primary analysis.||||||0.73|||||||Wilcoxon (Mann-Whitney)|||Two-sample t-tests or Wilcoxon rank-sum tests will be used >> to compare the AUC of CIPN sensory subscale between each of the two schedules of >> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory >> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory >> subscale scores from the AUC or incorporate them as a covariate in generalized linear >> regression model.|
1691816|NCT01099397|3110847|Superiority or Other|||||||0.41||||||P-value at 18 weeks|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p<0.05 was considered significant at 18 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)|
1691817|NCT01099397|3110847|Superiority or Other|||||||0.59||||||P-value at 9 weeks|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p<0.05 was considered significant at 9 week assessment; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)|
1691818|NCT01099397|3110847|Superiority or Other|||||||0.41||||||P-value at baseline|McNemar|McNemar was used at each of three time points to compare prediabetes diagnosis by fasting versus 2-hour OGTT||p<0.05 was considered significant at baseline; the null hypothesis was that there was no difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose), the alternative hypothesis was that there was a significant difference between prediabetes diagnosis (by 2-hour glucose or fasting glucose)|
1691819|NCT01098812|3110881|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Deviation|0.15||0.0009|1-Sided|90.0||-0.03||P-value compared to alpha level adjusted for multiplicity of 0.0125.|t-test, 1 sided|||Used LogMAR values for visual acuity; The null hypothesis is that the mean UCDVA for toric eyes is worse than or equal to that for control eyes; the alternate hypothesis is that the mean UCDVA for toric eyes is better than that for control eyes. There is 80% power to detect >=0.06 LogMAR difference in mean UCDVA between IOL groups.|
1691820|NCT01098812|3110882|Superiority or Other||Mean Difference (Final Values)|43.0|Standard Deviation|75.0|<|0.0001|1-Sided|90.0|25.0|||Primary study endpoint; therefore, no adjustment for multiple comparisons. The planned alpha level for testing was 0.025.|t-test, 1 sided|||Toric IOL results for mean percent reduction in cyl compared to control results at 6 months. Null hypothesis = mean reduction for toric eyes is <= to that of control eyes; alternate hypothesis = mean reduction for toric eyes is > the control. There is 80% power to detect >=31% difference in mean percent reduction in cylinder (postoperative refractive cylinder minus preoperative keratometric cylinder)/(target refractive cylinder minus preoperative keratometric cylinder) between IOL groups.|
1691821|NCT01098747|3110883|Superiority or Other||Hazard Ratio (HR)|0.04||||0.667|2-Sided|95.0|-0.15|0.24||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1691822|NCT01098747|3110883|Superiority or Other||Mean Difference (Final Values)|0.9|||<|0.001|2-Sided|95.0|0.83|0.98||p-value was calculated using CMH test with modified ridit scores, controlling for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium - placebo) and the associated CI were calculated based on the weighted Gamma statistic.|
1691823|NCT01098747|3110884|Superiority or Other||Difference in proportion|-9.23||||0.14|2-Sided|95.0|-21.62|3.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691824|NCT01098747|3110884|Superiority or Other||Difference in proportion|48.53|||<|0.001|2-Sided|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691825|NCT01098747|3110884|Superiority or Other||Difference in proportion|-9.23|||<|0.14|2-Sided|95.0|-21.62|3.16||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691826|NCT01098747|3110884|Superiority or Other||Difference in proportion|48.53|||<|0.001|2-Sided|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691827|NCT01098747|3110884|Superiority or Other||Difference in proportion|-8.61|||<|0.17|2-Sided|95.0|-21.02|3.8||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691828|NCT01098747|3110884|Superiority or Other||Difference in proportion|48.53|||<|0.001|2-Sided|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691829|NCT01098747|3110884|Superiority or Other||Difference in proportion|-8.01|||<|0.202|2-Sided|95.0|-20.44|4.41||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691830|NCT01098747|3110884|Superiority or Other||Difference in proportion|48.53|||<|0.001|2-Sided|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691831|NCT01098747|3110884|Superiority or Other||Difference in proportion|-6.8|||<|0.28|2-Sided|95.0|-19.24|5.65||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691907|NCT01098747|3110889|Superiority or Other||LS mean difference|19.83|||<|0.001|2-Sided|95.0|16.23|23.43||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691832|NCT01098747|3110884|Superiority or Other||Difference in proportion|48.53|||<|0.001|2-Sided|95.0|36.29|60.77||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691833|NCT01098747|3110884|Superiority or Other||Difference in proportion|-2.14|||<|0.739|2-Sided|95.0|-14.77|10.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691834|NCT01098747|3110884|Superiority or Other||Difference in proportion|52.81|||<|0.001|2-Sided|95.0|42.63|62.99||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691835|NCT01098747|3110884|Superiority or Other||Difference in proportion|4.55|||<|0.477|2-Sided|95.0|-8.03|17.13||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691836|NCT01098747|3110884|Superiority or Other||Difference in proportion|48.61|||<|0.001|2-Sided|95.0|38.49|58.73||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691837|NCT01098747|3110884|Superiority or Other||Difference in proportion|8.86|||<|0.149|2-Sided|95.0|-3.33|21.04||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691838|NCT01098747|3110884|Superiority or Other||Difference in proportion|41.16|||<|0.001|2-Sided|95.0|31.2|51.12||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691839|NCT01098747|3110884|Superiority or Other||Difference in proportion|6.66|||<|0.217|2-Sided|95.0|-4.31|17.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691840|NCT01098747|3110884|Superiority or Other||Difference in proportion|27.24|||<|0.001|2-Sided|95.0|18.14|36.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691841|NCT01098747|3110884|Superiority or Other||Difference in proportion|2.74|||<|0.303|2-Sided|95.0|-3.01|8.49||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691842|NCT01098747|3110884|Superiority or Other||Difference in proportion|6.34|||<|0.078|2-Sided|95.0|1.34|11.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691843|NCT01098747|3110885|Superiority or Other||Difference in proportion|6.05||||0.256|2-Sided|95.0|-4.75|16.84||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691844|NCT01098747|3110885|Superiority or Other||Difference in proportion|-52.79|||<|0.001|2-Sided|95.0|-66.77|-38.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691845|NCT01098747|3110885|Superiority or Other||Difference in proportion|3.72|||<|0.445|2-Sided|95.0|-5.94|13.38||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691846|NCT01098747|3110885|Superiority or Other||Difference in proportion|-56.84|||<|0.001|2-Sided|95.0|-70.84|-42.85||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1694053|NCT01065454|3115344|Superiority or Other (legacy)||LS-MEANS Difference|-8.36|||||2-Sided|95.0|-135.78|119.06|||||||
1691847|NCT01098747|3110885|Superiority or Other||Difference in proportion|1.56|||<|0.711|2-Sided|95.0|-6.68|9.81||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691848|NCT01098747|3110885|Superiority or Other||Difference in proportion|-59.28|||<|0.001|2-Sided|95.0|-73.05|-45.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691849|NCT01098747|3110885|Superiority or Other||Difference in proportion|1.1|||<|0.98|2-Sided|95.0|-7.44|7.63||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691850|NCT01098747|3110885|Superiority or Other||Difference in proportion|-60.31|||<|0.001|2-Sided|95.0|-74.28|-46.34||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691851|NCT01098747|3110885|Superiority or Other||Difference in proportion|1.52|||<|0.668|2-Sided|95.0|-5.47|8.52||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691852|NCT01098747|3110885|Superiority or Other||Difference in proportion|-61.36|||<|0.001|2-Sided|95.0|-75.21|-47.5||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691853|NCT01098747|3110885|Superiority or Other||Difference in proportion|-3.75|||<|0.24|2-Sided|95.0|-9.38|1.89||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691854|NCT01098747|3110885|Superiority or Other||Difference in proportion|-66.58|||<|0.001|2-Sided|95.0|-79.8|-53.35||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691855|NCT01098747|3110885|Superiority or Other||Difference in proportion|-3.61|||<|0.174|2-Sided|95.0|-7.97|0.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691856|NCT01098747|3110885|Superiority or Other||Difference in proportion|-51.93|||<|0.001|2-Sided|95.0|-65.63|-38.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691857|NCT01098747|3110885|Superiority or Other||Difference in proportion|-1.21|||<|0.483|2-Sided|95.0|-4.12|1.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691858|NCT01098747|3110885|Superiority or Other||Difference in proportion|-23.93|||<|0.001|2-Sided|95.0|-36.67|-11.2||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691859|NCT01098747|3110886|Superiority or Other||Hazard Ratio (HR)|1.33||||0.281|2-Sided|95.0|0.79|2.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1691860|NCT01098747|3110886|Superiority or Other||Hazard Ratio (HR)|0.13|||<|0.001|2-Sided|95.0|0.08|0.22||p-value was calculated using PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1691861|NCT01098747|3110887|Superiority or Other||Difference in proportion|7.28||||0.047|2-Sided|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1692033|NCT01098110|3111056|Superiority or Other||LS mean difference|-13.22|Standard Error of the Mean|2.09|<|0.0001|2-Sided|95.0|-17.33|-9.12||Statistical significant: p=<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID||
1691862|NCT01098747|3110887|Superiority or Other||Difference in proportion|72.61|||<|0.001|2-Sided|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691863|NCT01098747|3110887|Superiority or Other||Difference in proportion|7.28|||<|0.047|2-Sided|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691864|NCT01098747|3110887|Superiority or Other||Difference in proportion|72.61|||<|0.001|2-Sided|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691865|NCT01098747|3110887|Superiority or Other||Difference in proportion|7.28|||<|0.047|2-Sided|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691866|NCT01098747|3110887|Superiority or Other||Difference in proportion|72.61|||<|0.001|2-Sided|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691867|NCT01098747|3110887|Superiority or Other||Difference in proportion|7.28|||<|0.047|2-Sided|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691868|NCT01098747|3110887|Superiority or Other||Difference in proportion|72.61|||<|0.001|2-Sided|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691869|NCT01098747|3110887|Superiority or Other||Difference in proportion|7.28|||<|0.047|2-Sided|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691870|NCT01098747|3110887|Superiority or Other||Difference in proportion|72.61|||<|0.001|2-Sided|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691871|NCT01098747|3110887|Superiority or Other||Difference in proportion|7.28|||<|0.047|2-Sided|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691872|NCT01098747|3110887|Superiority or Other||Difference in proportion|72.61|||<|0.001|2-Sided|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691873|NCT01098747|3110887|Superiority or Other||Difference in proportion|7.81|||<|0.036|2-Sided|95.0|1.54|14.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691874|NCT01098747|3110887|Superiority or Other||Difference in proportion|72.61|||<|0.001|2-Sided|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691875|NCT01098747|3110887|Superiority or Other||Difference in proportion|8.35|||<|0.028|2-Sided|95.0|2.02|14.68||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691876|NCT01098747|3110887|Superiority or Other||Difference in proportion|72.61|||<|0.001|2-Sided|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1692132|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-38.2|||<|0.0001|2-Sided|95.0|-51.3|-25.1|||Mixed Models Analysis|||5:15am|
1691877|NCT01098747|3110887|Superiority or Other||Difference in proportion|10.14|||<|0.014|2-Sided|95.0|3.21|17.08||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691878|NCT01098747|3110887|Superiority or Other||Difference in proportion|73.72|||<|0.001|2-Sided|95.0|62.77|84.67||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691879|NCT01098747|3110887|Superiority or Other||Difference in proportion|23.45|||<|0.001|2-Sided|95.0|13.16|33.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691880|NCT01098747|3110887|Superiority or Other||Difference in proportion|69.53|||<|0.001|2-Sided|95.0|57.67|81.4||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691881|NCT01098747|3110887|Superiority or Other||Difference in proportion|14.35|||<|0.003|2-Sided|95.0|4.26|24.43||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691882|NCT01098747|3110887|Superiority or Other||Difference in proportion|20.01|||<|0.004|2-Sided|95.0|8.79|31.24||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691883|NCT01098747|3110888|Superiority or Other||Difference in proportion|7.28||||0.047|2-Sided|95.0|1.07|13.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691884|NCT01098747|3110888|Superiority or Other||Difference in proportion|72.61|||<|0.001|2-Sided|95.0|61.05|84.17||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691885|NCT01098747|3110888|Superiority or Other||Difference in proportion|7.84|||<|0.035|2-Sided|95.0|1.57|14.1||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691886|NCT01098747|3110888|Superiority or Other||Difference in proportion|74.71|||<|0.001|2-Sided|95.0|63.14|86.27||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691887|NCT01098747|3110888|Superiority or Other||Difference in proportion|6.79|||<|0.073|2-Sided|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691888|NCT01098747|3110888|Superiority or Other||Difference in proportion|73.58|||<|0.001|2-Sided|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691889|NCT01098747|3110888|Superiority or Other||Difference in proportion|6.79|||<|0.073|2-Sided|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691890|NCT01098747|3110888|Superiority or Other||Difference in proportion|73.58|||<|0.001|2-Sided|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691891|NCT01098747|3110888|Superiority or Other||Difference in proportion|6.79|||<|0.073|2-Sided|95.0|0.23|13.36||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1692133|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-38.2|||<|0.0001|2-Sided|95.0|-51.2|-25.2|||Mixed Models Analysis|||3:15am|
1691892|NCT01098747|3110888|Superiority or Other||Difference in proportion|73.58|||<|0.001|2-Sided|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691893|NCT01098747|3110888|Superiority or Other||Difference in proportion|8.01|||<|0.041|2-Sided|95.0|1.27|14.75||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691894|NCT01098747|3110888|Superiority or Other||Difference in proportion|73.58|||<|0.001|2-Sided|95.0|61.83|85.33||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691895|NCT01098747|3110888|Superiority or Other||Difference in proportion|11.7|||<|0.013|2-Sided|95.0|3.47|19.93||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691896|NCT01098747|3110888|Superiority or Other||Difference in proportion|72.63|||<|0.001|2-Sided|95.0|61.14|84.11||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691897|NCT01098747|3110888|Superiority or Other||Difference in proportion|17.44|||<|0.001|2-Sided|95.0|7.83|27.06||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691898|NCT01098747|3110888|Superiority or Other||Difference in proportion|72.65|||<|0.001|2-Sided|95.0|61.59|83.71||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691899|NCT01098747|3110888|Superiority or Other||Difference in proportion|21.25|||<|0.001|2-Sided|95.0|9.58|32.92||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691900|NCT01098747|3110888|Superiority or Other||Difference in proportion|61.35|||<|0.001|2-Sided|95.0|48.99|73.7||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691901|NCT01098747|3110888|Superiority or Other||Difference in proportion|11.82|||<|0.023|2-Sided|95.0|1.15|22.48||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691902|NCT01098747|3110888|Superiority or Other||Difference in proportion|24.36|||<|0.001|2-Sided|95.0|13.51|35.22||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691903|NCT01098747|3110888|Superiority or Other||Difference in proportion|0.54|||<|0.623|2-Sided|95.0|-1.88|2.95||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1691904|NCT01098747|3110888|Superiority or Other||Difference in proportion|1.01|||<|0.49|2-Sided|95.0|-0.97|3.0||p-value was calculated using CMH test which was adjusted for baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.25 hours-Treatment difference (Ibuprofen sodium - placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.|
1691905|NCT01098747|3110889|Superiority or Other||LS mean difference|-1.77||||0.323|2-Sided|95.0|-5.29|1.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-8 Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691906|NCT01098747|3110889|Superiority or Other||LS mean difference|-0.53||||0.69|2-Sided|95.0|-3.12|2.07||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-6: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1692134|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-1.8|||<|0.7852|2-Sided|95.0|-14.8|11.2|||Mixed Models Analysis|||3:15am|
1691908|NCT01098747|3110889|Superiority or Other||LS mean difference|0.87|||<|0.152|2-Sided|95.0|-0.32|2.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691909|NCT01098747|3110889|Superiority or Other||LS mean difference|10.43|||<|0.001|2-Sided|95.0|8.79|12.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691910|NCT01098747|3110889|Superiority or Other||LS mean difference|1.06|||<|0.007|2-Sided|95.0|0.29|1.84||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691911|NCT01098747|3110889|Superiority or Other||LS mean difference|6.68|||<|0.001|2-Sided|95.0|5.6|7.76||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691912|NCT01098747|3110890|Superiority or Other||LS mean difference|-1.1||||0.303|2-Sided|95.0|-3.2|1.0||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-8: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691913|NCT01098747|3110890|Superiority or Other||LS mean difference|14.27|||<|0.001|2-Sided|95.0|11.36|17.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691914|NCT01098747|3110890|Superiority or Other||LS mean difference|-0.3|||<|0.703|2-Sided|95.0|-1.84|1.24||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691915|NCT01098747|3110890|Superiority or Other||LS mean difference|11.67|||<|0.001|2-Sided|95.0|9.54|13.81||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691916|NCT01098747|3110890|Superiority or Other||LS mean difference|0.49|||<|0.166|2-Sided|95.0|-0.21|1.2||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691917|NCT01098747|3110890|Superiority or Other||LS mean difference|6.15|||<|0.001|2-Sided|95.0|5.18|7.12||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691918|NCT01098747|3110890|Superiority or Other||LS mean difference|0.62|||<|0.009|2-Sided|95.0|0.16|1.07||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691919|NCT01098747|3110890|Superiority or Other||LS mean difference|3.95|||<|0.001|2-Sided|95.0|3.32|4.59||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691920|NCT01098747|3110891|Superiority or Other||LS mean difference|-0.67||||0.367|2-Sided|95.0|-2.12|0.79||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-8: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691921|NCT01098747|3110891|Superiority or Other||LS mean difference|9.94|||<|0.001|2-Sided|95.0|7.92|11.96||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-8: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691922|NCT01098747|3110891|Superiority or Other||LS mean difference|-0.23|||<|0.679|2-Sided|95.0|-1.31|0.85||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691923|NCT01098747|3110891|Superiority or Other||LS mean difference|8.16|||<|0.001|2-Sided|95.0|6.66|9.66||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-6: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691924|NCT01098747|3110891|Superiority or Other||LS mean difference|0.37|||<|0.144|2-Sided|95.0|-0.13|0.87||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1694054|NCT01065454|3115344|Superiority or Other (legacy)||LS-MEANS Difference|-53.29|||||2-Sided|95.0|-162.46|55.88|||||||
1691925|NCT01098747|3110891|Superiority or Other||LS mean difference|4.29|||<|0.001|2-Sided|95.0|3.6|4.98||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691926|NCT01098747|3110891|Superiority or Other||LS mean difference|0.45|||<|0.007|2-Sided|95.0|0.12|0.78||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691927|NCT01098747|3110891|Superiority or Other||LS mean difference|2.73|||<|0.001|2-Sided|95.0|2.27|3.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691928|NCT01098747|3110892|Superiority or Other||LS mean difference|-0.65||||0.027|2-Sided|95.0|-1.23|-0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691929|NCT01098747|3110892|Superiority or Other||LS mean difference|2.05|||<|0.001|2-Sided|95.0|1.25|2.85||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691930|NCT01098747|3110892|Superiority or Other||LS mean difference|-0.59|||<|0.044|2-Sided|95.0|-1.16|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691931|NCT01098747|3110892|Superiority or Other||LS mean difference|2.33|||<|0.001|2-Sided|95.0|1.53|3.12||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691932|NCT01098747|3110892|Superiority or Other||LS mean difference|-0.58|||<|0.043|2-Sided|95.0|-1.15|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691933|NCT01098747|3110892|Superiority or Other||LS mean difference|2.8|||<|0.001|2-Sided|95.0|2.01|3.58||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691934|NCT01098747|3110892|Superiority or Other||LS mean difference|-0.41|||<|0.144|2-Sided|95.0|-0.95|0.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691935|NCT01098747|3110892|Superiority or Other||LS mean difference|3.2|||<|0.001|2-Sided|95.0|2.44|3.95||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691936|NCT01098747|3110892|Superiority or Other||LS mean difference|-0.4|||<|0.139|2-Sided|95.0|-0.93|0.13||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691937|NCT01098747|3110892|Superiority or Other||LS mean difference|3.4|||<|0.001|2-Sided|95.0|2.66|4.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691938|NCT01098747|3110892|Superiority or Other||LS mean difference|-0.2|||<|0.436|2-Sided|95.0|-0.7|0.3||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691939|NCT01098747|3110892|Superiority or Other||LS mean difference|3.75|||<|0.001|2-Sided|95.0|3.06|4.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691940|NCT01098747|3110892|Superiority or Other||LS mean difference|0.22|||<|0.359|2-Sided|95.0|-0.26|0.7||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691941|NCT01098747|3110892|Superiority or Other||LS mean difference|4.09|||<|0.001|2-Sided|95.0|3.42|4.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1692135|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-40.0|||<|0.0001|2-Sided|95.0|-53.0|-27.0|||Mixed Models Analysis|||3:15am|
1691942|NCT01098747|3110892|Superiority or Other||LS mean difference|0.58|||<|0.017|2-Sided|95.0|0.1|1.06||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691943|NCT01098747|3110892|Superiority or Other||LS mean difference|4.06|||<|0.001|2-Sided|95.0|3.4|4.72||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691944|NCT01098747|3110892|Superiority or Other||LS mean difference|0.64|||<|0.008|2-Sided|95.0|0.17|1.11||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691945|NCT01098747|3110892|Superiority or Other||LS mean difference|3.68|||<|0.001|2-Sided|95.0|3.03|4.33||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691946|NCT01098747|3110892|Superiority or Other||LS mean difference|0.91|||<|0.001|2-Sided|95.0|0.48|1.34||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691947|NCT01098747|3110892|Superiority or Other||LS mean difference|2.41|||<|0.001|2-Sided|95.0|1.82|3.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691948|NCT01098747|3110892|Superiority or Other||LS mean difference|0.46|||<|0.001|2-Sided|95.0|0.18|0.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691949|NCT01098747|3110892|Superiority or Other||LS mean difference|0.65|||<|0.001|2-Sided|95.0|0.26|1.04||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691950|NCT01098747|3110893|Superiority or Other||LS mean difference|-0.22||||0.074|2-Sided|95.0|-0.46|0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691951|NCT01098747|3110893|Superiority or Other||LS mean difference|0.85|||<|0.001|2-Sided|95.0|0.52|1.18||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691952|NCT01098747|3110893|Superiority or Other||LS mean difference|-0.22|||<|0.064|2-Sided|95.0|-0.46|0.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691953|NCT01098747|3110893|Superiority or Other||LS mean difference|0.93|||<|0.001|2-Sided|95.0|0.61|1.26||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691954|NCT01098747|3110893|Superiority or Other||LS mean difference|-0.25|||<|0.036|2-Sided|95.0|-0.49|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691955|NCT01098747|3110893|Superiority or Other||LS mean difference|1.17|||<|0.001|2-Sided|95.0|0.84|1.5||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691956|NCT01098747|3110893|Superiority or Other||LS mean difference|-0.17|||<|0.135|2-Sided|95.0|-0.4|0.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691957|NCT01098747|3110893|Superiority or Other||LS mean difference|1.31|||<|0.001|2-Sided|95.0|1.0|1.63||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691958|NCT01098747|3110893|Superiority or Other||LS mean difference|-0.17|||<|0.134|2-Sided|95.0|-0.4|0.05||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1692136|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-15.1|||<|0.0228|2-Sided|95.0|-28.1|-2.1|||Mixed Models Analysis|||3:15am|
1691959|NCT01098747|3110893|Superiority or Other||LS mean difference|1.39|||<|0.001|2-Sided|95.0|1.07|1.7||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691960|NCT01098747|3110893|Superiority or Other||LS mean difference|-0.08|||<|0.472|2-Sided|95.0|-0.29|0.14||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691961|NCT01098747|3110893|Superiority or Other||LS mean difference|1.56|||<|0.001|2-Sided|95.0|1.27|1.86||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691962|NCT01098747|3110893|Superiority or Other||LS mean difference|0.09|||<|0.362|2-Sided|95.0|-0.11|0.3||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691963|NCT01098747|3110893|Superiority or Other||LS mean difference|1.69|||<|0.001|2-Sided|95.0|1.41|1.98||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691964|NCT01098747|3110893|Superiority or Other||LS mean difference|0.25|||<|0.015|2-Sided|95.0|0.05|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691965|NCT01098747|3110893|Superiority or Other||LS mean difference|1.67|||<|0.001|2-Sided|95.0|1.39|1.96||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691966|NCT01098747|3110893|Superiority or Other||LS mean difference|0.25|||<|0.017|2-Sided|95.0|0.04|0.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691967|NCT01098747|3110893|Superiority or Other||LS mean difference|1.46|||<|0.001|2-Sided|95.0|1.18|1.75||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691968|NCT01098747|3110893|Superiority or Other||LS mean difference|0.38|||<|0.001|2-Sided|95.0|0.2|0.55||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691969|NCT01098747|3110893|Superiority or Other||LS mean difference|0.94|||<|0.001|2-Sided|95.0|0.7|1.19||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691970|NCT01098747|3110893|Superiority or Other||LS mean difference|0.22|||<|0.001|2-Sided|95.0|0.11|0.34||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691971|NCT01098747|3110893|Superiority or Other||LS mean difference|0.3|||<|0.001|2-Sided|95.0|0.13|0.46||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1691972|NCT01098747|3110894|Superiority or Other||LS mean difference|-0.44||||0.015|2-Sided|95.0|-0.79|-0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691973|NCT01098747|3110894|Superiority or Other||LS mean difference|1.2|||<|0.001|2-Sided|95.0|0.71|1.69||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691974|NCT01098747|3110894|Superiority or Other||LS mean difference|-0.37|||<|0.04|2-Sided|95.0|-0.71|-0.02||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691975|NCT01098747|3110894|Superiority or Other||LS mean difference|1.39|||<|0.001|2-Sided|95.0|0.91|1.88||p-value was calculated using ANOVA model with treatment, baseline PSR and gender PSR terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||7 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1692137|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-53.3|||<|0.0001|2-Sided|95.0|-66.3|-40.3|||Mixed Models Analysis|||3:15am|
1691976|NCT01098747|3110894|Superiority or Other||LS mean difference|-0.33|||<|0.055|2-Sided|95.0|-0.67|0.01||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691977|NCT01098747|3110894|Superiority or Other||LS mean difference|1.63|||<|0.001|2-Sided|95.0|1.16|2.1||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691978|NCT01098747|3110894|Superiority or Other||LS mean difference|-0.23|||<|0.16|2-Sided|95.0|-0.56|0.09||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691979|NCT01098747|3110894|Superiority or Other||LS mean difference|1.88|||<|0.001|2-Sided|95.0|1.43|2.33||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691980|NCT01098747|3110894|Superiority or Other||LS mean difference|-0.23|||<|0.151|2-Sided|95.0|-0.54|0.08||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691981|NCT01098747|3110894|Superiority or Other||LS mean difference|2.02|||<|0.001|2-Sided|95.0|1.58|2.45||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691982|NCT01098747|3110894|Superiority or Other||LS mean difference|-0.12|||<|0.42|2-Sided|95.0|-0.42|0.17||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691983|NCT01098747|3110894|Superiority or Other||LS mean difference|2.19|||<|0.001|2-Sided|95.0|1.78|2.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691984|NCT01098747|3110894|Superiority or Other||LS mean difference|0.13|||<|0.369|2-Sided|95.0|-0.15|0.41||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691985|NCT01098747|3110894|Superiority or Other||LS mean difference|2.39|||<|0.001|2-Sided|95.0|2.0|2.79||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691986|NCT01098747|3110894|Superiority or Other||LS mean difference|0.33|||<|0.022|2-Sided|95.0|0.05|0.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691987|NCT01098747|3110894|Superiority or Other||LS mean difference|2.39|||<|0.001|2-Sided|95.0|2.0|2.77||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691988|NCT01098747|3110894|Superiority or Other||LS mean difference|0.39|||<|0.006|2-Sided|95.0|0.12|0.66||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691989|NCT01098747|3110894|Superiority or Other||LS mean difference|2.22|||<|0.001|2-Sided|95.0|1.84|2.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691990|NCT01098747|3110894|Superiority or Other||LS mean difference|0.53|||<|0.001|2-Sided|95.0|0.27|0.8||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691991|NCT01098747|3110894|Superiority or Other||LS mean difference|1.47|||<|0.001|2-Sided|95.0|1.1|1.84||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95 % CI were calculated based on LS mean from the ANOVA model.|
1691992|NCT01098747|3110894|Superiority or Other||LS mean difference|0.24|||<|0.01|2-Sided|95.0|0.06|0.42||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference [Ibuprofen sodium - Ibuprofen (Advil + Motrin IB)] and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1692138|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|1.1|||<|0.8684|2-Sided|95.0|-11.9|14.1|||Mixed Models Analysis|||3:15am|
1691993|NCT01098747|3110894|Superiority or Other||LS mean difference|0.35|||<|0.007|2-Sided|95.0|0.1|0.6||p-value was calculated using ANOVA model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS mean from the ANOVA model.|
1691994|NCT01098747|3110895|Superiority or Other||Hazard Ratio (HR)|1.8|||<|0.001|2-Sided|95.0|1.38|2.34||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1691995|NCT01098747|3110895|Superiority or Other||Hazard Ratio (HR)|12.36|||<|0.001|2-Sided|95.0|6.51|23.46||p-value was calculated using the PH model with treatment, baseline PSR and gender terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1691996|NCT01098747|3110896|Superiority or Other||Hazard Ratio (HR)|1.59|||<|0.001|2-Sided|95.0|1.22|2.06||p-value was calculated using the PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.|
1691997|NCT01098747|3110896|Superiority or Other||Hazard Ratio (HR)|12.8|||<|0.001|2-Sided|95.0|6.78|24.15||p-value was calculated using the PH model with treatment, baseline PSR and gender terms.|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: IBU Na vs. Placebo for SPRID 0-8 then TMR, IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.|
1691998|NCT01098747|3110897|Superiority or Other||Least-square (LS) mean difference|24.21|||<|0.001|2-Sided|95.0|19.32|29.09||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR) and gender terms.|ANOVA|||Treatment difference (Ibuprofen sodium - placebo) and 95 percent (%) confidence interval (CI):based on LS means from analysis of variance(ANOVA). Type I error controlled at 5% significance level (2-sided) by testing primary endpoints sequentially: Ibuprofen sodium (IBU Na) versus(vs.) Placebo for SPRID 0-8 then time to meaningful relief(TMR), IBU Na vs. IBU (Advil and Motrin IB) for TMR. If comparison at preceding step was significant only then subsequent comparisons were significant.|
1691999|NCT01098539|3110916|Non-Inferiority or Equivalence|The p-value was from a 1-sided t test to test whether the difference of LS means (albiglutide – sitagliptin) was less than or equal to the prespecified noninferiority margin of 0.4%.|Median Difference (Final Values)|-0.32|||<|0.0001|2-Sided|95.0|-0.49|-0.15|||t-test, 1 sided||||
1692000|NCT01098500|3110925|Superiority or Other||Incidence Rate (IR)|0.4|||||2-Sided|95.0|0.0|2.0|||||Incidence rate (IR) is the number of patients with Hy’s Law after initiation of TKI divided by person time contributed by all patients with normal ALT, AST, ALP, and BIL (< 1 times ULN) at baseline. IR is expressed per 100 person years.||
1692001|NCT01098500|3110926|Superiority or Other||Prevalence percentage|0.4|||||2-Sided|95.0|0.1|1.4|||||Prevalence percentage is the number of patients with Hy’s Law divided by all patients that were tested at baseline (30 days prior to initiation of TKI drug).||
1692002|NCT01098500|3110927|Superiority or Other||Incidence Rate (IR)|6.2|||||2-Sided|95.0|3.3|9.0|||||Incidence rate (IR) is the number of patients with an ALT >=3 times ULN after initiation of TKI divided by person time contributed by all patients with normal ALT (<1 times ULN) at baseline. IR expressed per 100 person years.||
1692003|NCT01098500|3110928|Superiority or Other||Prevalence percentage|2.2|||||2-Sided|95.0|0.9|3.5|||||Prevalence percentage is the number of patients with an ALT >=3 times ULN divided by all patients that were tested at baseline (30 days prior to initiation of TKI drug).||
1692004|NCT01098461|3111007|Non-Inferiority or Equivalence|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-1.1|||<|0.0001|2-Sided|95.0|-1.43|-0.78|||t-test, 2 sided||||
1692005|NCT01098461|3111007|Non-Inferiority or Equivalence|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-1.55|||<|0.0001|2-Sided|95.0|-1.88|-1.23|||t-test, 2 sided||||
1692006|NCT01098461|3111007|Non-Inferiority or Equivalence|The p-value is from a two-sided t-test for the difference in means. Dunnett's method is used to adjust for multiple comparisons.|Mean Difference (Final Values)|-0.89|||<|0.0001|2-Sided|95.0|-1.22|-0.57|||t-test, 2 sided||||
1692007|NCT01098266|3111017|Other|Two-sided log-rank test was used to compare time to symptomatic progression between treatment arms. Median and 95% confidence limits for the time to symptomatic progression were estimated using Kaplan-Meier survival methodology. Estimates of the treatment effect were expressed as hazard ratio including 95% confidence intervals.|Hazard Ratio (HR)|0.92||||0.5806|2-Sided|95.0|0.68|1.26|||Log Rank|||QoL assessment was performed by using a questionnaire according to LCSS, which consists of nine 100-mm visual analog scales, with scores reported from 0 to 100(the best score). The LCSS subscore is the average symptom burden index computed as the mean score for all 6 major symptoms. Symptomatic progression was defined as a worsening in the average symptom burden index by 25%.|
1692008|NCT01098266|3111020|Superiority||Odds Ratio (OR)|1.13||||0.62|2-Sided|95.0|0.76|1.68|||Fisher Exact||Logistic regression analyses were performed to assess the influence of baseline covariates in an exploratory manner|Difference in DCR between the two treatment arms were tested using a chi-squared test with 95% confidence intervals calculated in each treatment arm.|
1692009|NCT01098266|3111021|Superiority||Hazard Ratio (HR)|0.95||||0.65|2-Sided|95.0|0.78|1.17|||Log Rank|Cox regression analyses (unstratified and stratified) was performed to assess the influence of baseline covariates in an exploratory manner.||The log-rank test (unstratified and stratified) was used at an alpha level of 5% to test for differences in PFS between the two treatment arms. Kaplan-Meier curves and estimates were provided.|
1692139|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-37.1|||<|0.0001|2-Sided|95.0|-50.1|-24.1|||Mixed Models Analysis|||3:15am|
1692010|NCT01098266|3111022|Superiority||Hazard Ratio (HR)|0.94||||0.58|2-Sided|95.0|0.75|1.18||The log-rank test (unstratified) was used to compare the two treatment arms. In addition, a stratified version of the log-rank test was performed with the stratification factors used for randomization.|Log Rank|Cox regression analyses (unstratified and stratified) were performed to assess the influence of baseline covariates in an exploratory manner.||Study with one control per experimental patient, an accrual interval of 24 months, and an additional FU after the accrual interval of 12 months.If the true HR of experimental relative to control patients was 0.726, then 195 experimental patients and 195 control patients were required to be able to reject the null hypothesis that the experimental and control survival curves were equal with probability (power)0.80 Type I error probability associated with this test of this null hypothesis was 0.05|
1692011|NCT01098110|3111045|Superiority or Other||Mean Difference (Final Values)|28.8|||<|0.0001|2-Sided|95.0|18.9|38.8||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 10 mg BID minus Placebo BID||
1692012|NCT01098110|3111045|Superiority or Other||Mean Difference (Final Values)|22.2|||<|0.0001|2-Sided|95.0|12.0|32.4||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 5 mg BID minus Placebo BID||
1692013|NCT01098110|3111046|Superiority or Other||LS mean difference|-0.59|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.82|-0.36|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID||
1692014|NCT01098110|3111046|Superiority or Other||Least square (LS) means difference|-0.52|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.75|-0.28|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID||
1692015|NCT01098110|3111047|Superiority or Other||Mean Difference (Final Values)|23.1|||<|0.0001|2-Sided|95.0|13.7|32.6||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 10 mg BID minus Placebo BID||
1692016|NCT01098110|3111047|Superiority or Other||Mean Difference (Final Values)|18.6|||<|0.0001|2-Sided|95.0|9.2|28.1||Adjusted for region.|Cochran-Mantel-Haenszel||Asenapine 5 mg BID minus Placebo BID||
1692017|NCT01098110|3111048|Superiority or Other||LS mean difference|-1.53|Standard Error of the Mean|0.32|<|0.0001|2-Sided|95.0|-2.16|-0.91|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID||
1692018|NCT01098110|3111048|Superiority or Other||Least square (LS) means difference|-1.41|Standard Error of the Mean|0.32|<|0.0001|2-Sided|95.0|-2.04|-0.78|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID||
1692019|NCT01098110|3111049|Superiority or Other||LS mean difference|-2.26|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|-3.04|-1.47|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID||
1692020|NCT01098110|3111049|Superiority or Other||Least square (LS) means difference|-1.62|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|-2.41|-0.83|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID||
1692021|NCT01098110|3111050|Superiority or Other||LS mean difference|-3.08|Standard Error of the Mean|0.51|<|0.0001|2-Sided|95.0|-4.09|-2.08|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID||
1692022|NCT01098110|3111050|Superiority or Other||Least square (LS) means difference|-2.72|Standard Error of the Mean|0.52|<|0.0001|2-Sided|95.0|-3.73|-1.7|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID||
1692023|NCT01098110|3111051|Superiority or Other||LS mean difference|-2.94|Standard Error of the Mean|0.56|<|0.0001|2-Sided|95.0|-4.03|-1.84|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 10 mg BID minus Placebo BID||
1692024|NCT01098110|3111051|Superiority or Other||Least square (LS) means difference|-2.36|Standard Error of the Mean|0.56|<|0.0001|2-Sided|95.0|-3.47|-1.26|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 5 mg BID minus Placebo BID||
1692025|NCT01098110|3111052|Superiority or Other||LS mean difference|-3.66|Standard Error of the Mean|0.67|<|0.0001|2-Sided|95.0|-4.97|-2.35|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID||
1692026|NCT01098110|3111052|Superiority or Other||Least square (LS) means difference|-3.41|Standard Error of the Mean|0.67|<|0.0001|2-Sided|95.0|-4.72|-2.09|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID||
1692027|NCT01098110|3111053|Superiority or Other||LS mean difference|-6.53|Standard Error of the Mean|1.06|<|0.0001|2-Sided|95.0|-8.62|-4.44||Statistical significant: p=<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID||
1692028|NCT01098110|3111053|Superiority or Other||Least square (LS) means difference|-5.46|Standard Error of the Mean|1.07|<|0.0001|2-Sided|95.0|-7.56|-3.35|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID||
1692029|NCT01098110|3111054|Superiority or Other||LS mean difference|-3.03|Standard Error of the Mean|0.54|<|0.0001|2-Sided|95.0|-4.08|-1.97|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 10 mg BID minus Placebo BID||
1692030|NCT01098110|3111054|Superiority or Other||Least square (LS) means difference|-2.47|Standard Error of the Mean|0.54|<|0.0001|2-Sided|95.0|-3.53|-1.41|||ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID||
1692031|NCT01098110|3111055|Superiority or Other||LS mean difference|-3.79|Standard Error of the Mean|0.67|<|0.0001|2-Sided|95.0|-5.11|-2.46|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 10 mg BID minus Placebo BID||
1692032|NCT01098110|3111055|Superiority or Other||Least square (LS) means difference|-3.47|Standard Error of the Mean|0.68|<|0.0001|2-Sided|95.0|-4.8|-2.13|||ANCOVA|Change from baseline a response variable, baseline score a covariate.|Asenapine 5 mg BID minus Placebo BID||
1692034|NCT01098110|3111056|Superiority or Other||Least square (LS) means difference|-11.29|Standard Error of the Mean|2.1|<|0.0001|2-Sided|95.0|-15.42|-7.16||Statistical significant: p=<0.05, two sided|ANCOVA|Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables.|Asenapine 5 mg BID minus Placebo BID||
1692035|NCT01097915|3111095|Superiority or Other||||||<|1e-05|||||||Chi-squared||||
1692036|NCT01097915|3111096|Superiority or Other||||||<|1e-05|||||||ANOVA||||
1692037|NCT01097915|3111097|Superiority or Other||||||<|1e-05|||||||ANOVA||||
1692038|NCT01097915|3111098|Superiority or Other||||||<|0.048|||||||ANCOVA|the three factors of the Stunkard and Messick Questionnaire were considered as covariates.|||
1692039|NCT01097915|3111099|Superiority or Other||||||<|0.004|||||||ANOVA||||
1692040|NCT01097915|3111100|Superiority or Other||||||<|0.01|||||||Fisher Exact||||
1692041|NCT01097785|3111102|Superiority or Other||||||<|0.05|||||||Student's t-test||||
1692042|NCT01097785|3111103|Superiority or Other||||||<|0.05|||||||Student's t-test||||
1692043|NCT01097694|3111115|Superiority|||||||0.47|||||||Regression, Linear|Adjusted for baseline.|||
1692044|NCT01097694|3111116|Superiority|||||||0.56|||||||Regression, Linear|Adjusted for baseline.|||
1692045|NCT01097694|3111117|Superiority|||||||0.18|||||||Regression, Linear|Adjusted for baseline.|||
1692046|NCT01097694|3111118|Superiority|||||||0.54|||||||Regression, Linear|Adjusted for baseline.|||
1692047|NCT01097694|3111119|Superiority|||||||0.25|||||||Regression, Linear|Adjusted for baseline|||
1692048|NCT01097694|3111120|Superiority|||||||0.13|||||||Regression, Linear|Adjusted for baseline|||
1692049|NCT01097694|3111121|Superiority|||||||0.94|||||||Regression, Linear|Adjusted for baseline.|||
1692050|NCT01097694|3111122|Superiority|||||||0.07|||||||Regression, Linear|Adjusted for baseline.|||
1692051|NCT01097694|3111123|Superiority|||||||0.11|||||||Regression, Linear|Adjusted for baseline.|||
1692052|NCT01097694|3111124|Superiority|||||||0.33|||||||Regression, Linear|Adjusted for baseline.|||
1692053|NCT01097694|3111125|Superiority|||||||0.15|||||||Regression, Linear|Adjusted for baseline|||
1692054|NCT01097694|3111126|Superiority|||||||0.57|||||||Regression, Linear|Adjusted for baseline.|||
1692055|NCT01097694|3111127|Superiority|||||||0.62|||||||Regression, Linear|Adjusted for baseline.|||
1692056|NCT01097694|3111128|Superiority|||||||0.11|||||||Regression, Linear|Adjusted for baseline|||
1692057|NCT01097694|3111129|Superiority|||||||0.31|||||||Regression, Linear|Adjusted for baseline.|||
1692058|NCT01097694|3111130|Superiority|||||||0.11|||||||Regression, Linear|Adjusted for baseline|||
1692059|NCT01097694|3111131|Superiority|||||||0.31|||||||Mixed Models Analysis|Adjusted for baseline.|||
1692060|NCT01097694|3111132|Superiority|||||||0.38|||||||Mixed Models Analysis|Adjusted for baseline|||
1692061|NCT01097694|3111133|Superiority|||||||0.06|||||||Mixed Models Analysis|Adjusted for baseline.||For FEV1% we used a linear mixed-effects model to assess the between-group difference in the change from baseline over weeks 8-24.|
1692062|NCT01097694|3111134|Superiority||||||<|0.05|||||||Mixed Models Analysis|adjusted for baseline values||For FEV1 we used a linear mixed-effects model to assess the between-group difference in the change from baseline over weeks 8-24.|
1692063|NCT01097694|3111135|Superiority|||||||0.36|||||||Poisson regression model||||
1692064|NCT01097694|3111136|Superiority|||||||0.1|||||||Regression, Linear|Adjusted for baseline.|||
1692065|NCT01097694|3111137|Superiority|||||||0.12|||||||Regression, Linear|Adjusted for baseline.|||
1692066|NCT01097694|3111138|Superiority||||||<|0.05|||||||Regression, Linear|Adjusted for baseline.|||
1692067|NCT01097694|3111139|Superiority||||||<|0.05|||||||Mixed Models Analysis|||"Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed.~The target enrollment was 60 assuming 10% drop-out for 54 completions which gave us 80% power to detect a doubling-dose change in PC20."|
1692068|NCT01097668|3111140|Superiority or Other|||||||0.03|||||||negative binomial model|||Comparison of the baseline 'MRI population' data with data from week 16.|
1692069|NCT01097668|3111140|Superiority or Other||||||<|0.001|||||||negative binomial model|||Comparison of the baseline 'ITT population' MRI data with week 16 data.|
1692070|NCT01097629|3111148|Superiority or Other (legacy)||Difference in Least Squares Means|-21.7|||<|1e-05|2-Sided|95.0|-28.6|-14.9|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 LPS, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.|
1692071|NCT01097629|3111149|Superiority or Other (legacy)||Difference in Least Squares Means|-13.1|||<|1e-05|2-Sided|95.0|-17.7|-8.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.|
1692072|NCT01097629|3111150|Superiority or Other (legacy)||Difference in Least Squares Means|-42.0|||<|1e-05|2-Sided|95.0|-48.6|-35.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 WASO, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.|
1692073|NCT01097629|3111151|Superiority or Other (legacy)||Difference in Least Squares Means|26.4|||<|1e-05|2-Sided|95.0|19.8|33.1|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSTm, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.|
1692074|NCT01097629|3111152|Superiority or Other (legacy)||Difference in Least Squares Means|-3.6||||0.2651|2-Sided|95.0|-10.1|2.8||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 LPS, had planned marginal power of 76.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692075|NCT01097629|3111153|Superiority or Other (legacy)||Difference in Least Squares Means|-12.1||||4e-05|2-Sided|95.0|-17.8|-6.4||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 LPS, had planned marginal power of 81.4%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692076|NCT01097629|3111154|Superiority or Other (legacy)||Difference in Least Squares Means|-13.2||||3e-05|2-Sided|95.0|-19.4|-7.0||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692077|NCT01097629|3111155|Superiority or Other (legacy)||Difference in Least Squares Means|-12.8||||3e-05|2-Sided|95.0|-18.8|-6.9||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSOm, had planned marginal power of 99.9%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692078|NCT01097629|3111156|Superiority or Other (legacy)||Difference in Least Squares Means|-29.4|||<|1e-05|2-Sided|95.0|-36.7|-22.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 WASO, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692079|NCT01097629|3111157|Superiority or Other (legacy)||Difference in Least Squares Means|-29.4|||<|1e-05|2-Sided|95.0|-36.6|-22.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 WASO, had planned marginal power of 99.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692080|NCT01097629|3111158|Superiority or Other (legacy)||Difference in Least Squares Means|25.1|||<|1e-05||95.0|16.0|34.2||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSTm, had planned marginal power of 95.7%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692081|NCT01097629|3111159|Superiority or Other (legacy)||Difference in Least Squares Means|26.3|||<|1e-05|2-Sided|95.0|18.3|34.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, time by treatment interaction, and cohort (e-diary only, PSG-plus-e-diary).||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSTm, had planned marginal power of 97.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692140|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-23.6|||<|0.0001|2-Sided|95.0|-34.5|-12.8|||Mixed Models Analysis|||1:15am|
1692141|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-2.9|||<|0.6029|2-Sided|95.0|-13.7|8.0|||Mixed Models Analysis|||1:15am|
1692082|NCT01097616|3111160|Superiority or Other||Difference in Least Squares Means|-8.1||||0.00606|2-Sided|95.0|-13.8|-2.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.|
1692083|NCT01097616|3111161|Superiority or Other||Difference in Least Squares Means|-10.3||||0.0004|2-Sided|95.0|-16.0|-4.6|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.|
1692084|NCT01097616|3111162|Superiority or Other||Difference in Least Squares Means|-10.3||||2e-05|2-Sided|95.0|-15.0|-5.5|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 LPS, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.|
1692085|NCT01097616|3111162|Superiority or Other||Difference in Least Squares Means|-9.6||||0.00041|2-Sided|95.0|-14.9|-4.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.|
1692086|NCT01097616|3111165|Superiority or Other||Difference in Least Squares Means|-5.2||||0.03771|2-Sided|95.0|-10.2|-0.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.|
1692087|NCT01097616|3111166|Superiority or Other||Difference in Least Squares Means|-5.4||||0.05191|2-Sided|95.0|-10.9|0.0|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.|
1692088|NCT01097616|3111167|Superiority or Other||Difference in Least Squares Means|-5.7||||0.00609|2-Sided|95.0|-9.7|-1.6|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.|
1692089|NCT01097616|3111167|Superiority or Other||Difference in Least Squares Means|-5.6||||0.01564|2-Sided|95.0|-10.2|-1.1|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.|
1692090|NCT01097616|3111168|Superiority or Other||Difference in Least Squares Means|-16.6||||9e-05|2-Sided|95.0|-24.8|-8.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.|
1692091|NCT01097616|3111169|Superiority or Other||Difference in Least Squares Means|-26.4|||<|1e-05|2-Sided|95.0|-34.3|-18.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.|
1692142|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-26.5|||<|0.0001|2-Sided|95.0|-37.4|-15.6|||Mixed Models Analysis|||1:15am|
1692143|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-1.5|||<|0.7867|2-Sided|95.0|-12.4|9.4|||Mixed Models Analysis|||1:15am|
1692144|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-25.1|||<|0.0001|2-Sided|95.0|-36.0|-14.3|||Mixed Models Analysis|||1:15am|
1692092|NCT01097616|3111170|Superiority or Other||Difference in Least Squares Means|-38.4|||<|1e-05|2-Sided|95.0|-44.5|-32.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Night 1 WASO, had planned marginal power of 100.0%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.|
1692093|NCT01097616|3111170|Superiority or Other||Difference in Least Squares Means|-32.5|||<|1e-05|2-Sided|95.0|-39.3|-25.7|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.|
1692094|NCT01097616|3111171|Superiority or Other||Difference in Least Squares Means|10.7||||0.01711|2-Sided|95.0|1.9|19.5|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.|
1692095|NCT01097616|3111172|Superiority or Other||Difference in Least Squares Means|16.3||||0.00016|2-Sided|95.0|7.9|24.8|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.|
1692096|NCT01097616|3111173|Superiority or Other||Difference in Least Squares Means|21.4|||<|1e-05|2-Sided|95.0|15.5|27.4|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Week 1 sTSTm, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either subjective or objective Month 3 endpoint must be significant to test Week 1/Night 1 endpoints. The same approach was used for sleep onset endpoints.|
1692097|NCT01097616|3111173|Superiority or Other||Difference in Least Squares Means|13.6|||<|7e-05|2-Sided|95.0|6.9|20.3|||Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||Sleep maintenance and sleep onset endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints and either the subjective or objective Month 3 endpoint must be significant to test the Week 1/Night 1 endpoints. A sleep maintenance LD endpoint was tested if ≥1 HD Month 3 endpoint for sleep maintenance and corresponding HD endpoint were significant. The same approach was used for sleep onset endpoints.|
1692098|NCT01097616|3111174|Superiority or Other||Difference in Least Squares Means|-9.4||||0.00037|2-Sided|95.0|-14.6|-4.3||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 LPS, had planned marginal power of 76.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692099|NCT01097616|3111175|Superiority or Other||Difference in Least Squares Means|-11.2||||2e-05|2-Sided|95.0|-16.3|-6.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 LPS, had planned marginal power of 81.4%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692100|NCT01097616|3111176|Superiority or Other||[Difference in Least Squares Means|-8.4||||0.00019|2-Sided|95.0|-12.8|-4.0||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSOm, had planned marginal power of 99.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692101|NCT01097616|3111177|Superiority or Other||Difference in Least Squares Means|-7.4||||0.00298|2-Sided|95.0|-12.3|-2.5||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSOm, had planned marginal power of 99.9%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692145|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-1.5|||<|0.7824|2-Sided|95.0|-12.4|9.4|||Mixed Models Analysis|||1:15am|
1692102|NCT01097616|3111178|Superiority or Other||Difference in Least Squares Means|-22.9|||<|1e-05|2-Sided|95.0|-30.3|-15.4||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 WASO, had planned marginal power of 98.3%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692103|NCT01097616|3111179|Superiority or Other||Difference in Least Squares Means|-26.3|||<|1e-05|2-Sided|95.0|-33.5|-19.2||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 WASO, had planned marginal power of 99.2%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692104|NCT01097616|3111180|Superiority or Other||Difference in Least Squares Means|19.7|||<|1e-05|2-Sided|95.0|11.9|27.6||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 3 sTSTm, had planned marginal power of 95.7%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692105|NCT01097616|3111181|Superiority or Other||Difference in Least Squares Means|19.6|||<|1e-05|2-Sided|95.0|12.0|27.1||By multiplicity strategy above, overall Type I error among primary hypotheses was controlled at two-sided 5% significance level.|Longitudinal Data Analysis|Model terms: baseline value, age group, region, gender, treatment, time, and time by treatment interaction.||The null hypothesis, that suvorexant HD did not differ from placebo for Month 1 sTSTm, had planned marginal power of 97.6%. Sleep maintenance (sTSTm, WASO) and sleep onset (sTSOm, LPS) endpoints were tested at two-sided 2.5% significance level. Both Month 1 endpoints for sleep maintenance must be significant to test Month 3 endpoints; the same approach was used for sleep onset endpoints.|
1692106|NCT01097343|3111191|Superiority or Other||||||=|0|||||||Chi-squared|||A sample of size of 50 patients for the cross-over study was chosen because it provided 80% power to detect a decrease in the rate of high on-clopidogrel platelet reactivity (HPR, defined as >230 PRU) from 75% to 46% with high dose clopidogrel, with a two-sided alpha of 0.05|
1692107|NCT01097304|3111195|Other|||||||0.48|||||||t-test, 2 sided||||
1692108|NCT01097304|3111196|Other||||||<|0.01|||||||signed rank test||||
1692109|NCT01097304|3111197|Other||||||<|0.0001|||||||signed rank test||||
1692110|NCT01097304|3111198|Other|||||||0.54|||||||t-test, 2 sided||||
1692111|NCT01096784|3111255|Superiority or Other|||||||0.0642|||||||CMH Row Mean Score Test||||
1692112|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-19.4||||0.2098|2-Sided|95.0|-49.9|11.1|||Mixed Models Analysis|||9:15am|
1692113|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|9.1||||0.5533|2-Sided|95.0|-21.3|39.6|||Mixed Models Analysis|||9:15am|
1692114|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-10.3||||0.5048|2-Sided|95.0|-40.6|20.1|||Mixed Models Analysis|||9:15am|
1692115|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-16.8||||0.2785|2-Sided|95.0|-47.2|13.7|||Mixed Models Analysis|||9:15am|
1692116|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-36.2||||0.0199|2-Sided|95.0|-66.5|-5.8|||Mixed Models Analysis|||9:15am|
1692117|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.8975|2-Sided|95.0|-32.4|28.5|||Mixed Models Analysis|||9:15am|
1692118|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-21.4||||0.1655|2-Sided|95.0|-51.7|9.0|||Mixed Models Analysis|||9:15am|
1692119|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-36.4||||0.001|2-Sided|95.0|-57.8|-14.9|||Mixed Models Analysis|||7:15am|
1692120|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|0.1||||0.9903|2-Sided|95.0|-21.3|21.6|||Mixed Models Analysis|||7:15am|
1692121|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-36.3||||0.0011|2-Sided|95.0|-57.7|-14.8|||Mixed Models Analysis|||7:15am|
1692122|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-16.5||||0.1307|2-Sided|95.0|-37.9|5.0|||Mixed Models Analysis|||7:15am|
1692123|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-52.9|||<|0.0001|2-Sided|95.0|-74.3|-31.4|||Mixed Models Analysis|||7:15am|
1692124|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-1.2|||<|0.9089|2-Sided|95.0|-22.7|20.2|||Mixed Models Analysis|||7:15am|
1692125|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-37.6|||<|0.0007|2-Sided|95.0|-59.1|-16.2|||Mixed Models Analysis|||7:15am|
1692126|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-42.1|||<|0.0001|2-Sided|95.0|-55.2|-29.1|||Mixed Models Analysis|||5:15am|
1692127|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-7.1|||<|0.2868|2-Sided|95.0|-20.1|6.0|||Mixed Models Analysis|||5:15am|
1692128|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-49.2|||<|0.0001|2-Sided|95.0|-62.2|-36.1|||Mixed Models Analysis|||5:15am|
1692129|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-11.8|||<|0.0747|2-Sided|95.0|-24.9|1.2|||Mixed Models Analysis|||5:15am|
1692130|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-53.9|||<|0.0001|2-Sided|95.0|-67.0|-40.9|||Mixed Models Analysis|||5:15am|
1692131|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|3.9|||<|0.5528|2-Sided|95.0|-9.1|17.0|||Mixed Models Analysis|||5:15am|
1692147|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-20.0|||<|0.0001|2-Sided|95.0|-28.3|-11.7|||Mixed Models Analysis|||11:15pm|
1692148|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|1.9|||<|0.6566|2-Sided|95.0|-6.4|10.2|||Mixed Models Analysis|||11:15pm|
1692149|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-18.1|||<|0.0001|2-Sided|95.0|-26.4|-9.8|||Mixed Models Analysis|||11:15pm|
1692150|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|1.6|||<|0.6999|2-Sided|95.0|-6.7|9.9|||Mixed Models Analysis|||11:15pm|
1692151|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-18.4|||<|0.0001|2-Sided|95.0|-26.7|-10.1|||Mixed Models Analysis|||11:15pm|
1692152|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|3.3|||<|0.4321|2-Sided|95.0|-5.0|11.6|||Mixed Models Analysis|||11:15pm|
1692153|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-16.7|||<|0.0001|2-Sided|95.0|-25.1|-8.3|||Mixed Models Analysis|||11:15pm|
1692154|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-5.8|||<|0.242|2-Sided|95.0|-15.6|4.0|||Mixed Models Analysis|||9:15pm|
1692155|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-0.6|||<|0.9052|2-Sided|95.0|-10.4|9.2|||Mixed Models Analysis|||9:15pm|
1692156|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-6.4|||<|0.1971|2-Sided|95.0|-16.2|3.4|||Mixed Models Analysis|||9:15pm|
1692157|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-2.3|||<|0.6467|2-Sided|95.0|-12.0|7.5|||Mixed Models Analysis|||9:15pm|
1692158|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-8.1|||<|0.1046|2-Sided|95.0|-17.9|1.7|||Mixed Models Analysis|||9:15pm|
1692159|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-3.8|||<|0.441|2-Sided|95.0|-13.6|6.0|||Mixed Models Analysis|||9:15pm|
1692160|NCT01096680|3111266|Superiority or Other||Mean Difference (Final Values)|-9.6|||<|0.0544|2-Sided|95.0|-19.4|0.2|||Mixed Models Analysis|||9:15pm|
1692161|NCT01096680|3111267|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.9743|2-Sided|95.0|-10.2|9.9|||Mixed Models Analysis||||
1692162|NCT01096680|3111267|Superiority or Other||Mean Difference (Final Values)|-8.9||||0.0814|2-Sided|95.0|-18.9|1.1|||Mixed Models Analysis||||
1692163|NCT01096680|3111267|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9945|2-Sided|95.0|-10.1|10.0|||Mixed Models Analysis||||
1692164|NCT01096680|3111267|Superiority or Other||Mean Difference (Final Values)|-26.5|||<|0.0001|2-Sided|95.0|-36.6|-16.5|||Mixed Models Analysis||||
1692165|NCT01096680|3111267|Superiority or Other||Mean Difference (Final Values)|-26.7|||<|0.0001|2-Sided|95.0|-36.7|-16.6|||Mixed Models Analysis||||
1692166|NCT01096680|3111267|Superiority or Other||Mean Difference (Final Values)|-35.4|||<|0.0001|2-Sided|95.0|-45.5|-25.4|||Mixed Models Analysis||||
1692167|NCT01096680|3111267|Superiority or Other||Mean Difference (Final Values)|-26.5|||<|0.0001|2-Sided|95.0|-36.6|-16.5|||Mixed Models Analysis||||
1692168|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.7133|2-Sided|95.0|-1.4|0.9|||Mixed Models Analysis|||10:50am|
1692169|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.0925|2-Sided|95.0|-2.2|0.2|||Mixed Models Analysis|||10:50am|
1692170|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.0413|2-Sided|95.0|-2.4|0.0|||Mixed Models Analysis|||10:50am|
1692171|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.3323|2-Sided|95.0|-1.7|0.6|||Mixed Models Analysis|||10:50am|
1692172|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.1824|2-Sided|95.0|-1.9|0.4|||Mixed Models Analysis|||10:50am|
1692173|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.2||||0.7558|2-Sided|95.0|-1.0|1.3|||Mixed Models Analysis|||10:50am|
1692174|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9552|2-Sided|95.0|-1.2|1.1|||Mixed Models Analysis|||10:50am|
1692175|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.6889|2-Sided|95.0|-1.3|0.8|||Mixed Models Analysis|||9:50am|
1692176|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.0303|2-Sided|95.0|-2.2|-0.1|||Mixed Models Analysis|||9:50am|
1692177|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.0107|2-Sided|95.0|-2.5|-0.3|||Mixed Models Analysis|||9:50am|
1692178|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.0527|2-Sided|95.0|-2.1|0.0|||Mixed Models Analysis|||9:50am|
1692179|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.02|2-Sided|95.0|-2.3|-0.2|||Mixed Models Analysis|||9:50am|
1692180|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9417|2-Sided|95.0|-1.1|1.0|||Mixed Models Analysis|||9:50am|
1692181|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.6364|2-Sided|95.0|-1.3|0.8|||Mixed Models Analysis|||9:50am|
1692182|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.7||||0.2529|2-Sided|95.0|-0.5|1.8|||Mixed Models Analysis|||8:50am|
1692183|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.0065|2-Sided|95.0|-2.8|-0.5|||Mixed Models Analysis|||8:50am|
1692184|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.1079|2-Sided|95.0|-2.1|0.2|||Mixed Models Analysis|||8:50am|
1692185|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.0751|2-Sided|95.0|-2.2|0.1|||Mixed Models Analysis|||8:50am|
1692186|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.5197|2-Sided|95.0|-1.5|0.8|||Mixed Models Analysis|||8:50am|
1692187|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.7978|2-Sided|95.0|-1.3|1.0|||Mixed Models Analysis|||8:50am|
1692188|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.5||||0.375|2-Sided|95.0|-0.6|1.7|||Mixed Models Analysis|||8:50am|
1692189|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.3198|2-Sided|95.0|-1.6|0.5|||Mixed Models Analysis|||7:50am|
1692190|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.0007|2-Sided|95.0|-3.0|-0.8|||Mixed Models Analysis|||7:50am|
1692191|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-2.5|||<|0.0001|2-Sided|95.0|-3.6|-1.4|||Mixed Models Analysis|||7:50am|
1692192|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.1|||<|0.0498|2-Sided|95.0|-2.2|0.0|||Mixed Models Analysis|||7:50am|
1692193|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.6|||<|0.0035|2-Sided|95.0|-2.7|-0.5|||Mixed Models Analysis|||7:50am|
1692194|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.1|||<|0.8369|2-Sided|95.0|-1.2|1.0|||Mixed Models Analysis|||7:50am|
1692195|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.231|2-Sided|95.0|-1.8|0.4|||Mixed Models Analysis|||7:50am|
1692196|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.6|||<|0.2476|2-Sided|95.0|-1.7|0.4|||Mixed Models Analysis|||6:50am|
1692197|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.9|||<|0.0006|2-Sided|95.0|-2.9|-0.8|||Mixed Models Analysis|||6:50am|
1692198|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-2.5|||<|0.0001|2-Sided|95.0|-3.6|-1.4|||Mixed Models Analysis|||6:50am|
1692199|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.0|||<|0.0708|2-Sided|95.0|-2.0|0.1|||Mixed Models Analysis|||6:50am|
1692200|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.6|||<|0.0034|2-Sided|95.0|-2.7|-0.5|||Mixed Models Analysis|||6:50am|
1692201|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.1|||<|0.894|2-Sided|95.0|-1.0|1.1|||Mixed Models Analysis|||6:50am|
1692202|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.6|||<|0.3067|2-Sided|95.0|-1.6|0.5|||Mixed Models Analysis|||6:50am|
1692203|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.8|||<|0.1246|2-Sided|95.0|-1.8|0.2|||Mixed Models Analysis|||5:50am|
1692204|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.7|||<|0.0015|2-Sided|95.0|-2.7|-0.7|||Mixed Models Analysis|||5:50am|
1692205|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-2.5|||<|0.0001|2-Sided|95.0|-3.5|-1.5|||Mixed Models Analysis|||5:50am|
1692206|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.2|||<|0.0279|2-Sided|95.0|-2.2|-0.1|||Mixed Models Analysis|||5:50am|
1692207|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-2.0|||<|0.0003|2-Sided|95.0|-3.0|-0.9|||Mixed Models Analysis|||5:50am|
1692208|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.4|||<|0.4405|2-Sided|95.0|-0.6|1.4|||Mixed Models Analysis|||5:50am|
1692209|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.4|||<|0.4427|2-Sided|95.0|-1.4|0.6|||Mixed Models Analysis|||5:50am|
1692210|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.6|||<|0.2462|2-Sided|95.0|-1.6|0.4|||Mixed Models Analysis|||4:50am|
1692211|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.8|||<|0.0006|2-Sided|95.0|-2.8|-0.8|||Mixed Models Analysis|||4:50am|
1692212|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-2.4|||<|0.0001|2-Sided|95.0|-3.4|-1.4|||Mixed Models Analysis|||4:50am|
1692213|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.6|||<|0.0022|2-Sided|95.0|-2.6|-0.6|||Mixed Models Analysis|||4:50am|
1692214|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-2.2|||<|0.0001|2-Sided|95.0|-3.2|-1.2|||Mixed Models Analysis|||4:50am|
1692215|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.1|||<|0.8871|2-Sided|95.0|-0.9|1.1|||Mixed Models Analysis|||4:50am|
1692216|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.3093|2-Sided|95.0|-1.5|0.5|||Mixed Models Analysis|||4:50am|
1692217|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.9|||<|0.0883|2-Sided|95.0|-1.9|0.1|||Mixed Models Analysis|||3:50am|
1692218|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.8|||<|0.0008|2-Sided|95.0|-2.8|-0.8|||Mixed Models Analysis|||3:50am|
1692219|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-2.7|||<|0.0001|2-Sided|95.0|-3.7|-1.6|||Mixed Models Analysis|||3:50am|
1692220|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.6|||<|0.0022|2-Sided|95.0|-2.6|-0.6|||Mixed Models Analysis|||3:50am|
1692221|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-2.5|||<|0.0001|2-Sided|95.0|-3.5|-1.5|||Mixed Models Analysis|||3:50am|
1692222|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.5624|2-Sided|95.0|-1.3|0.7|||Mixed Models Analysis|||3:50am|
1692223|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.2|||<|0.0234|2-Sided|95.0|-2.2|-0.2|||Mixed Models Analysis|||3:50am|
1692224|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.0|||<|0.048|2-Sided|95.0|-2.0|0.0|||Mixed Models Analysis|||2:50am|
1692225|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.2|||<|0.016|2-Sided|95.0|-2.2|-0.2|||Mixed Models Analysis|||2:50am|
1692226|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-2.2|||<|0.0001|2-Sided|95.0|-3.2|-1.2|||Mixed Models Analysis|||2:50am|
1692227|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.9|||<|0.0611|2-Sided|95.0|-1.9|0.0|||Mixed Models Analysis|||2:50am|
1692228|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.9|||<|0.0002|2-Sided|95.0|-2.9|-0.9|||Mixed Models Analysis|||2:50am|
1692229|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.2|||<|0.7071|2-Sided|95.0|-1.2|0.8|||Mixed Models Analysis|||2:50am|
1696411|NCT01033942|3118852|Superiority or Other|||||||0.042|||||||Fisher Exact||||
1692230|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.2|||<|0.0193|2-Sided|95.0|-2.2|-0.2|||Mixed Models Analysis|||2:50am|
1692231|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.9|||<|0.0441|2-Sided|95.0|-1.7|0.0|||Mixed Models Analysis|||1:50am|
1692232|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.8|||<|0.0782|2-Sided|95.0|-1.6|0.1|||Mixed Models Analysis|||1:50am|
1692233|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.7|||<|0.0002|2-Sided|95.0|-2.5|-0.8|||Mixed Models Analysis|||1:50am|
1692234|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.6|||<|0.1643|2-Sided|95.0|-1.5|0.3|||Mixed Models Analysis|||1:50am|
1692235|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.5|||<|0.0008|2-Sided|95.0|-2.3|-0.6|||Mixed Models Analysis|||1:50am|
1692236|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.2|||<|0.6138|2-Sided|95.0|-0.6|1.1|||Mixed Models Analysis|||1:50am|
1692237|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.1302|2-Sided|95.0|-1.5|0.2|||Mixed Models Analysis|||1:50am|
1692238|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.2|||<|0.0039|2-Sided|95.0|-2.0|-0.4|||Mixed Models Analysis|||12:50am|
1692239|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.1131|2-Sided|95.0|-1.5|0.2|||Mixed Models Analysis|||12:50am|
1692240|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.9|||<|0.0001|2-Sided|95.0|-2.7|-1.1|||Mixed Models Analysis|||12:50am|
1692241|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.4|||<|0.3535|2-Sided|95.0|-1.2|0.4|||Mixed Models Analysis|||12:50am|
1692242|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.6|||<|0.0002|2-Sided|95.0|-2.4|-0.8|||Mixed Models Analysis|||12:50am|
1692243|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.4|||<|0.3757|2-Sided|95.0|-0.5|1.2|||Mixed Models Analysis|||12:50am|
1692244|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.8|||<|0.0428|2-Sided|95.0|-1.7|0.0|||Mixed Models Analysis|||12:50am|
1692245|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.4|||<|0.2863|2-Sided|95.0|-1.2|0.4|||Mixed Models Analysis|||11:50pm|
1692246|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.0|||<|0.0211|2-Sided|95.0|-1.8|-0.1|||Mixed Models Analysis|||11:50pm|
1692247|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.4|||<|0.0009|2-Sided|95.0|-2.2|-0.6|||Mixed Models Analysis|||11:50pm|
1692248|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.3965|2-Sided|95.0|-1.2|0.5|||Mixed Models Analysis|||11:50pm|
1692249|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.8|||<|0.0571|2-Sided|95.0|-1.6|0.0|||Mixed Models Analysis|||11:50pm|
1692250|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.2|||<|0.5843|2-Sided|95.0|-1.0|0.6|||Mixed Models Analysis|||11:50pm|
1692251|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.1086|2-Sided|95.0|-1.5|0.1|||Mixed Models Analysis|||11:50pm|
1692252|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.8|||<|0.0413|2-Sided|95.0|-1.5|0.0|||Mixed Models Analysis|||10:50pm|
1692253|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.2072|2-Sided|95.0|-1.2|0.3|||Mixed Models Analysis|||10:50pm|
1692254|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-1.2|||<|0.0012|2-Sided|95.0|-2.0|-0.5|||Mixed Models Analysis|||10:50pm|
1692255|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.3|||<|0.4534|2-Sided|95.0|-0.5|1.0|||Mixed Models Analysis|||10:50pm|
1692256|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.1936|2-Sided|95.0|-1.2|0.3|||Mixed Models Analysis|||10:50pm|
1692257|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.1|||<|0.7625|2-Sided|95.0|-0.9|0.6|||Mixed Models Analysis|||10:50pm|
1692258|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.9|||<|0.0199|2-Sided|95.0|-1.6|-0.1|||Mixed Models Analysis|||10:50pm|
1692259|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.1|||<|0.8358|2-Sided|95.0|-0.7|0.6|||Mixed Models Analysis|||9:50pm|
1692260|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.1479|2-Sided|95.0|-1.1|0.2|||Mixed Models Analysis|||9:50pm|
1692261|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.0998|2-Sided|95.0|-1.2|0.1|||Mixed Models Analysis|||9:50pm|
1692262|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.1|||<|0.8557|2-Sided|95.0|-0.6|0.7|||Mixed Models Analysis|||9:50pm|
1692263|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.0|||<|0.9798|2-Sided|95.0|-0.7|0.6|||Mixed Models Analysis|||9:50pm|
1692264|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.2|||<|0.4924|2-Sided|95.0|-0.9|0.4|||Mixed Models Analysis|||9:50pm|
1692265|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.3732|2-Sided|95.0|-0.9|0.4|||Mixed Models Analysis|||9:50pm|
1692266|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.3678|2-Sided|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm|
1692267|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.1|||<|0.8085|2-Sided|95.0|-0.6|0.5|||Mixed Models Analysis|||8:50pm|
1692268|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.2572|2-Sided|95.0|-0.9|0.2|||Mixed Models Analysis|||8:50pm|
1692269|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.0|||<|0.9581|2-Sided|95.0|-0.6|0.5|||Mixed Models Analysis|||8:50pm|
1692270|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.3419|2-Sided|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm|
1696412|NCT01033942|3118853|Superiority or Other|||||||0.1348|||||||Fisher Exact||||
1692271|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.0|||<|0.9019|2-Sided|95.0|-0.5|0.6|||Mixed Models Analysis|||8:50pm|
1692272|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.2|||<|0.4395|2-Sided|95.0|-0.8|0.3|||Mixed Models Analysis|||8:50pm|
1692273|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.2887|2-Sided|95.0|-0.8|0.2|||Mixed Models Analysis|||7:50pm|
1692274|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.0|||<|0.9831|2-Sided|95.0|-0.5|0.5|||Mixed Models Analysis|||7:50pm|
1692275|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.3028|2-Sided|95.0|-0.8|0.3|||Mixed Models Analysis|||7:50pm|
1692276|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.4|||<|0.1169|2-Sided|95.0|-0.1|1.0|||Mixed Models Analysis|||7:50pm|
1692277|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.1|||<|0.609|2-Sided|95.0|-0.4|0.7|||Mixed Models Analysis|||7:50pm|
1692278|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.4|||<|0.1798|2-Sided|95.0|-0.2|0.9|||Mixed Models Analysis|||7:50pm|
1692279|NCT01096680|3111268|Superiority or Other||Mean Difference (Final Values)|0.1|||<|0.7758|2-Sided|95.0|-0.5|0.6|||Mixed Models Analysis|||7:50pm|
1692280|NCT01096680|3111269|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.0004|2-Sided|95.0|-1.7|-0.5|||Mixed Models Analysis||||
1692281|NCT01096680|3111269|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.0297|2-Sided|95.0|-1.3|-0.1|||Mixed Models Analysis||||
1692282|NCT01096680|3111269|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9393|2-Sided|95.0|-0.6|0.6|||Mixed Models Analysis||||
1692283|NCT01096680|3111269|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.0947|2-Sided|95.0|-1.1|0.1|||Mixed Models Analysis||||
1692284|NCT01096680|3111269|Superiority or Other||Mean Difference (Final Values)|-1.6|||<|0.0001|2-Sided|95.0|-2.2|-1.0|||Mixed Models Analysis||||
1692285|NCT01096680|3111269|Superiority or Other||Mean Difference (Final Values)|-1.2|||<|0.0002|2-Sided|95.0|-1.8|-0.6|||Mixed Models Analysis||||
1692286|NCT01096680|3111269|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.1123|2-Sided|95.0|-1.1|0.1|||Mixed Models Analysis||||
1692287|NCT01096680|3111270|Superiority or Other||Mean Difference (Final Values)|1.7||||0.0351|2-Sided|95.0|0.1|3.2|||Mixed Models Analysis||||
1692288|NCT01096680|3111270|Superiority or Other||Mean Difference (Final Values)|0.3||||0.7601|2-Sided|95.0|-1.5|2.1|||Mixed Models Analysis||||
1692289|NCT01096680|3111270|Superiority or Other||Mean Difference (Final Values)|-4.3||||0.0014|2-Sided|95.0|-6.9|-1.8|||Mixed Models Analysis||||
1692290|NCT01096680|3111270|Superiority or Other||Mean Difference (Final Values)|12.3|||<|0.0001|2-Sided|95.0|9.9|14.7|||Mixed Models Analysis||||
1692291|NCT01096680|3111270|Superiority or Other||Mean Difference (Final Values)|14.0|||<|0.0001|2-Sided|95.0|11.7|16.2|||Mixed Models Analysis||||
1692292|NCT01096680|3111270|Superiority or Other||Mean Difference (Final Values)|12.6|||<|0.0001|2-Sided|95.0|10.2|15.0|||Mixed Models Analysis||||
1692293|NCT01096680|3111270|Superiority or Other||Mean Difference (Final Values)|8.0|||<|0.0001|2-Sided|95.0|5.0|10.9|||Mixed Models Analysis||||
1692294|NCT01096667|3111273|Superiority or Other||Difference in least squares means|8.65||||0.886|2-Sided|80.0|-0.56|17.87||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.|||
1692295|NCT01096667|3111273|Superiority or Other||Difference in least squares means|-26.59||||0|2-Sided|80.0|-35.84|-17.33||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.|||
1692296|NCT01096667|3111273|Superiority or Other||Difference in least squares means|-17.0||||0.011|2-Sided|80.0|-26.39|-7.61||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.|||
1692297|NCT01096667|3111273|Superiority or Other||Difference in least squares means|-5.54||||0.224|2-Sided|80.0|-14.89|3.82||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.|||
1692298|NCT01096667|3111274|Superiority or Other||Difference in least squares means|-0.61||||0.467|2-Sided|80.0|-9.86|8.65||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.|||
1692299|NCT01096667|3111274|Superiority or Other||Difference in least squares means|-35.42||||0|2-Sided|80.0|-44.78|-26.07||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.|||
1692300|NCT01096667|3111274|Superiority or Other||Difference in least squares means|-34.81||||0|2-Sided|80.0|-44.19|-25.43||P-value is one-sided. P-value rounded to thousandths.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.|||
1692301|NCT01096667|3111274|Superiority or Other||Difference in least squares means|-18.1||||0.007|2-Sided|80.0|-27.45|-8.75||P-value is one-sided.|Mixed Model for Repeated Measures|With treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline FPG as the covariate.|||
1692302|NCT01096667|3111276|Superiority or Other||Difference in least squares means|-4.63||||0.713|2-Sided|80.0|-15.22|5.96||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692303|NCT01096667|3111276|Superiority or Other||Difference in least squares means|70.34||||0|2-Sided|80.0|59.58|81.1||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692437|NCT01092663|3111769|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692304|NCT01096667|3111276|Superiority or Other||Difference in least squares means|60.39||||0|2-Sided|80.0|49.47|71.31||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692305|NCT01096667|3111276|Superiority or Other||Difference in least squares means|42.18||||0|2-Sided|80.0|31.42|52.94||P-value is one-sided. P-value rounded to thousandths.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692306|NCT01096667|3111278|Superiority or Other||Difference in least squares means|-3.33||||0.02|2-Sided|80.0|-5.4|-1.25||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.|||
1692307|NCT01096667|3111278|Superiority or Other||Difference in least squares means|-3.84||||0.01|2-Sided|80.0|-5.95|-1.73||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.|||
1692308|NCT01096667|3111278|Superiority or Other||Difference in least squares means|-1.12||||0.248|2-Sided|80.0|-3.23|0.99||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.|||
1692309|NCT01096667|3111278|Superiority or Other||Difference in least squares means|-4.2||||0.005|2-Sided|80.0|-6.3|-2.1||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.|||
1692310|NCT01096667|3111280|Superiority or Other||Difference in least squares means|-1.07||||0.246|2-Sided|80.0|-3.06|0.93||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692311|NCT01096667|3111280|Superiority or Other||Difference in least squares means|-1.82||||0.123|2-Sided|80.0|-3.82|0.19||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692312|NCT01096667|3111280|Superiority or Other||Difference in least squares means|1.61||||0.838|2-Sided|80.0|-0.49|3.71||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692313|NCT01096667|3111280|Superiority or Other||Difference in least squares means|0.02||||0.506|2-Sided|80.0|-1.96|2.0||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692314|NCT01096667|3111281|Superiority or Other||Difference in least squares means|-1.64||||0.118|2-Sided|80.0|-3.42|0.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692315|NCT01096667|3111281|Superiority or Other||Difference in least squares means|-2.65||||0.029|2-Sided|80.0|-4.43|-0.87||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692316|NCT01096667|3111281|Superiority or Other||Difference in least squares means|-0.48||||0.37|2-Sided|80.0|-2.33|1.38||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692317|NCT01096667|3111281|Superiority or Other||Difference in least squares means|-3.38||||0.007|2-Sided|80.0|-5.13|-1.63||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692318|NCT01096667|3111282|Superiority or Other||Difference in least squares means|-1.56||||0.11|2-Sided|80.0|-3.19|0.07||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692319|NCT01096667|3111282|Superiority or Other||Difference in least squares means|-2.39||||0.031|2-Sided|80.0|-4.02|-0.75||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692320|NCT01096667|3111282|Superiority or Other||Difference in least squares means|0.07||||0.521|2-Sided|80.0|-1.63|1.77||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692321|NCT01096667|3111282|Superiority or Other||Difference in least squares means|-2.22||||0.039|2-Sided|80.0|-3.83|-0.61||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692322|NCT01096667|3111284|Superiority or Other||Difference in least squares means|-2.84||||0.021|2-Sided|80.0|-4.63|-1.06||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.|||
1692323|NCT01096667|3111284|Superiority or Other||Difference in least squares means|-3.02||||0.017|2-Sided|80.0|-4.83|-1.2||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.|||
1692324|NCT01096667|3111284|Superiority or Other||Difference in least squares means|-1.05||||0.229|2-Sided|80.0|-2.86|0.77||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.|||
1692325|NCT01096667|3111284|Superiority or Other||Difference in least squares means|-1.2||||0.196|2-Sided|80.0|-3.01|0.6||P-value is one-sided.|Mixed Measures Repeated Model|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.|||
1692326|NCT01096667|3111286|Superiority or Other||Difference in least squares means|-1.58||||0.148|2-Sided|80.0|-3.51|0.36||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692327|NCT01096667|3111286|Superiority or Other||Difference in least squares means|-1.88||||0.111|2-Sided|80.0|-3.82|0.09||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692328|NCT01096667|3111286|Superiority or Other||Difference in least squares means|-3.54||||0.013|2-Sided|80.0|-5.58|-1.51||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692329|NCT01096667|3111286|Superiority or Other||Difference in least squares means|-2.5||||0.048|2-Sided|80.0|-4.43|-0.57||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692330|NCT01096667|3111287|Superiority or Other||Difference in least squares means|-2.57||||0.011|2-Sided|80.0|-4.0|-1.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.|||
1692331|NCT01096667|3111287|Superiority or Other||Difference in least squares means|-2.64||||0.01|2-Sided|80.0|-4.09|-1.19||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.|||
1692332|NCT01096667|3111287|Superiority or Other||Difference in least squares means|-2.75||||0.01|2-Sided|80.0|-4.26|-1.24||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.|||
1692333|NCT01096667|3111287|Superiority or Other||Difference in least squares means|-2.99||||0.004|2-Sided|80.0|-4.43|-1.55||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.|||
1692334|NCT01096667|3111288|Superiority or Other||Difference in least squares means|-2.19||||0.021|2-Sided|80.0|-3.56|-0.82||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.|||
1692335|NCT01096667|3111288|Superiority or Other||Difference in least squares means|-2.27||||0.018|2-Sided|80.0|-3.65|-0.88||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.|||
1692336|NCT01096667|3111288|Superiority or Other||Difference in least squares means|-3.11||||0.003|2-Sided|80.0|-4.55|-1.67||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.|||
1692337|NCT01096667|3111288|Superiority or Other||Difference in least squares means|-2.66||||0.007|2-Sided|80.0|-4.03|-1.29||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate. p-value is one-sided.|||
1692338|NCT01096667|3111290|Superiority or Other||Difference in least squares means|-4.37||||0.033|2-Sided|80.0|-7.41|-1.33||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.|||
1692339|NCT01096667|3111290|Superiority or Other||Difference in least squares means|-6.2||||0.005|2-Sided|80.0|-9.28|-3.11||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.|||
1692340|NCT01096667|3111290|Superiority or Other||Difference in least squares means|-7.16||||0.002|2-Sided|80.0|-10.25|-4.07||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.|||
1692341|NCT01096667|3111290|Superiority or Other||Difference in least squares means|-4.01||||0.047|2-Sided|80.0|-7.09|-0.94||P-value is one-sided.|Mixed Model for Repeated Measures|With terms for treatment, visit, and treatment-by-visit interaction as fixed effects, participant as random effect and baseline as the covariate.|||
1692342|NCT01096667|3111292|Superiority or Other||Difference in least squares means|-2.01||||0.174|2-Sided|80.0|-4.77|0.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692343|NCT01096667|3111292|Superiority or Other||Difference in least squares means|-2.02||||0.174|2-Sided|80.0|-4.79|0.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692344|NCT01096667|3111292|Superiority or Other||Difference in least squares means|-3.18||||0.078|2-Sided|80.0|-6.06|-0.3||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692345|NCT01096667|3111292|Superiority or Other||Difference in least squares means|-2.19||||0.152|2-Sided|80.0|-4.93|0.54||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692346|NCT01096667|3111293|Superiority or Other||Difference in least squares means|-3.92||||0.013|2-Sided|80.0|-6.16|-1.67||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692347|NCT01096667|3111293|Superiority or Other||Difference in least squares means|-4.99||||0.002|2-Sided|80.0|-7.24|-2.74||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692348|NCT01096667|3111293|Superiority or Other||Difference in least squares means|-4.43||||0.008|2-Sided|80.0|-6.78|-2.09||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692349|NCT01096667|3111293|Superiority or Other||Difference in least squares means|-3.7||||0.018|2-Sided|80.0|-5.94|-1.46||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692350|NCT01096667|3111295|Superiority or Other||Difference in least squares means|-3.21||||0.024|2-Sided|80.0|-5.3|-1.13||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692351|NCT01096667|3111295|Superiority or Other||Difference in least squares means|-3.69||||0.012|2-Sided|80.0|-5.78|-1.6||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692352|NCT01096667|3111295|Superiority or Other||Difference in least squares means|-4.0||||0.01|2-Sided|80.0|-6.17|-1.82||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692353|NCT01096667|3111295|Superiority or Other||Difference in least squares means|-2.97||||0.034|2-Sided|80.0|-5.05|-0.89||P-value is one-sided.|ANCOVA|Based on ANCOVA with treatment as fixed effect and baseline as a covariate.|||
1692354|NCT01096446|3111304|Non-Inferiority or Equivalence|The Chi Square satistical calculation was used for analysis.||||||0.011|||||||Chi-squared|||Four infants(44%)in the control group developed hypertriglyceridemia (>200 mg/dl) while 100% of the infants in the experimental group developed hypertriglyceridemia (>200 mg/dl) during the first week of life.|
1692355|NCT01096160|3111317|Other|Difference in change from baseline in cGMP|Geometric Mean Ratio|0.78||||0.297|2-Sided|90.0|0.35|1.73|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.|
1692356|NCT01096160|3111317|Other|Difference in change from baseline in cGMP|Geometric Mean Ratio|0.41||||0.054|2-Sided|90.0|0.16|1.02|||Linear mixed effcts model||||
1692357|NCT01096160|3111317|Other|Difference in change from baseline in cGMP|Geometric Mean Ratio|1.66||||0.17|2-Sided|90.0|0.66|4.17|||Linear mixed effects model||||
1692358|NCT01096160|3111317|Other|Difference in change from baseline in cGMP|Geometric Mean Ratio|1.28||||0.318|2-Sided|90.0|0.53|3.05|||Linear mixed effects model||||
1692359|NCT01096160|3111318|Other|Difference in change from baseline in AIx (TWA^0-24hrs)|Mean Difference (Final Values)|-6.79||||0.019|2-Sided|90.0|-12.1|-1.46|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.|
1692360|NCT01096160|3111318|Other|Comparison of Day 10 values (TWA^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-5.18||||0.08|2-Sided|90.0|-11.3|0.95|||Linear mixed effcts model||||
1692361|NCT01096160|3111318|Other|Comparison of Day 10 values (TWA^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-11.2||||0.002|2-Sided|90.0|-17.3|-5.1|||Linear mixed effects model||||
1692362|NCT01096160|3111318|Other|Comparison of Day 10 values (TWA^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|-9.87||||0.003|2-Sided|90.0|-15.7|-4.09|||Linear mixed effects model||||
1692363|NCT01096160|3111319|Other|Comparison of Day 10 values (TWA^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|4.06||||0.0869|2-Sided|90.0|-0.89|9.01|||Linear mixed effects model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.|
1692364|NCT01096160|3111319|Other|Comparison of Day 10 values (TWA^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|0.26||||0.4689|2-Sided|90.0|-5.42|5.95|||Linear mixed effects model||||
1692365|NCT01096160|3111319|Other|Comparison of Day 10 values (TWA^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|7.28||||0.0189|2-Sided|90.0|1.6|12.97|||Linear mixed effects model||||
1692366|NCT01096160|3111319|Other|Comparison of Day 10 values (TWA^0-24hrs) for MK-8266 vs placebo|Mean Difference (Final Values)|3.85||||0.1161|2-Sided|90.0|-1.51|9.22|||Linear mixed effects model||||
1692367|NCT01096160|3111320|Other|Difference in change from baseline in SBP (TWA^0-24hrs)|Mean Difference (Final Values)|-8.21||||0.0705|2-Sided|90.0|-17.4|1.01|||Linear mixed effcts model|||Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.|
1692368|NCT01096160|3111320|Other|Difference in change from baseline in SBP (TWA^0-24hrs)|Mean Difference (Final Values)|0.33||||0.4791|2-Sided|90.0|-10.3|10.91|||Linear mixed effects model||||
1692369|NCT01096160|3111320|Other|Difference in change from baseline in SBP (TWA^0-24hrs)|Mean Difference (Final Values)|-13.1||||0.0224|2-Sided|90.0|-23.7|-2.48|||Linear mixed effects model||||
1692370|NCT01096160|3111320|Other|Difference in change from baseline in SBP (TWA^0-24hrs)|Mean Difference (Final Values)|-7.08||||0.1194|2-Sided|90.0|-17.1|2.92|||Linear mixed effects model||||
1692371|NCT01095835|3111370|Superiority or Other|||||||0.08|||||||Chi-squared||||
1692372|NCT01095796|3111377|Non-Inferiority or Equivalence|A total of 700 HIV-1 infected participants, randomized in a 1:1 ratio to 2 groups would achieve at least 95% power to establish noninferiority in Week 48 response (HIV-1 RNA < 50 copies/mL per the FDA-defined snapshot analysis) rate difference between the 2 groups. For sample size and power computation, it was assumed that both treatment groups have a response rate of 0.795, a noninferiority margin of 0.12, and that the significance level of the test is at a one-sided, 0.025 level.|Difference in response rates|3.6|||||2-Sided|95.2|-1.6|8.8|||||To preserve the overall alpha level: 0.05, accounting for 2 interim analyses for Independent Data Monitoring Committee meetings, the 95.2% CI was computed using normal approximation stratified by baseline HIV-1 RNA (≤ 100,000 or > 100,000 copies/mL).|The null hypothesis was that the percentage of participants achieving HIV-1 RNA < 50 copies/mL (as defined by the snapshot analysis algorithm) at Week 48 in the Stribild group is at least 12% worse than the response rate in the Atripla group; the alternative hypothesis was that the response rate in the Stribild group is less than 12% worse than that in the Atripla Group.|
1692373|NCT01095666|3111381|Superiority or Other||Difference in percentage|15.5|Standard Error of the Mean|4.594||0.0007|2-Sided|95.0|6.5|24.5||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|Modified logistic regression|Modified logistic regression model, adjusted for baseline HbA1c|||
1692374|NCT01095666|3111381|Superiority or Other||Difference in percentage|15.4|Standard Error of the Mean|4.702||0.001|2-Sided|95.0|6.2|24.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|Modified logistic regression|Modified logistic regression model, adjusted for baseline HbA1c|||
1692375|NCT01095666|3111382|Superiority or Other||Mean Difference (Final Values)|-1.82|Standard Error of the Mean|0.2747|<|0.0001|2-Sided|95.0|-2.36|-1.28||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA||||
1692376|NCT01095666|3111382|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.2765|<|0.0001|2-Sided|95.0|-1.65|-0.56||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA||||
1692377|NCT01095666|3111383|Superiority or Other||Mean Difference (Final Values)|-49.1|Standard Error of the Mean|5.7921|<|0.0001|2-Sided|95.0|-60.53|-37.74||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA||||
1692378|NCT01095666|3111383|Superiority or Other||Mean Difference (Final Values)|-42.3|Standard Error of the Mean|5.8758|<|0.0001|2-Sided|95.0|-53.84|-30.73||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA||||
1692379|NCT01095666|3111384|Superiority or Other||Mean Difference (Final Values)|-27.1|Standard Error of the Mean|3.271|<|0.0001|2-Sided|95.0|-33.5|-20.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA||||
1692380|NCT01095666|3111384|Superiority or Other||Mean Difference (Final Values)|-22.1|Standard Error of the Mean|3.299|<|0.0001|2-Sided|95.0|-28.6|-15.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05.|ANCOVA||||
1692381|NCT01095666|3111385|Superiority or Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.0865|<|0.0001|2-Sided|95.0|-0.79|-0.45||Primary endpoints were tested at alpha=0.027 applying Dunnett’s adjustment.|ANCOVA||||
1692382|NCT01095666|3111385|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|0.0869|<|0.0001|2-Sided|95.0|-0.76|-0.42||Primary endpoints were tested at alpha=0.027 applying Dunnett’s adjustment.|ANCOVA||||
1692383|NCT01095653|3111386|Superiority or Other||Mean Difference (Final Values)|28.5|Standard Error of the Mean|5.022|<|0.0001|2-Sided|95.0|18.6|38.3||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression||||
1692384|NCT01095653|3111386|Superiority or Other||Mean Difference (Final Values)|21.3|Standard Error of the Mean|5.238|<|0.0001|2-Sided|95.0|11.1|31.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression||||
1692385|NCT01095653|3111387|Superiority or Other||Mean Difference (Final Values)|-1.98|Standard Error of the Mean|0.3242|<|0.0001|2-Sided|95.0|-2.62|-1.34||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1692386|NCT01095653|3111387|Superiority or Other||Mean Difference (Final Values)|-1.37|Standard Error of the Mean|0.3259|<|0.0001|2-Sided|95.0|-2.01|-0.73||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1692387|NCT01095653|3111388|Superiority or Other||Mean Difference (Final Values)|-56.0|Standard Error of the Mean|6.4489|<|0.0001|2-Sided|95.0|-68.66|-43.28||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1692388|NCT01095653|3111388|Superiority or Other||Mean Difference (Final Values)|-47.9|Standard Error of the Mean|6.5667|<|0.0001|2-Sided|95.0|-60.8|-34.96||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1692389|NCT01095653|3111389|Superiority or Other||Mean Difference (Final Values)|-34.2|Standard Error of the Mean|3.174|<|0.0001|2-Sided|95.0|-40.4|-27.9||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1692390|NCT01095653|3111389|Superiority or Other||Mean Difference (Final Values)|-27.7|Standard Error of the Mean|3.203|<|0.0001|2-Sided|95.0|-34.0|-21.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1692391|NCT01095653|3111390|Superiority or Other||Mean Difference (Final Values)|-0.82|Standard Error of the Mean|0.0962|<|0.0001|2-Sided|95.0|-1.01|-0.63||Primary endpoints were tested at alpha=0.027 applying Dunnett’s adjustment|ANCOVA||||
1692392|NCT01095653|3111390|Superiority or Other||Mean Difference (Final Values)|-0.75|Standard Error of the Mean|0.0975|<|0.0001|2-Sided|95.0|-0.94|-0.56||Primary endpoints were tested at alpha=0.027 applying Dunnett’s adjustment|ANCOVA||||
1692393|NCT01095003|3111407|Superiority|||||||0.0089|||||||Cochran-Mantel-Haenszel||||
1692394|NCT01095003|3111408|Superiority|||||||0.103|||||||Cochran-Mantel-Haenszel||||
1692395|NCT01095003|3111409|Superiority||Hazard Ratio (HR)|0.98||||0.7657|2-Sided|95.0|0.83|1.15|||Log Rank||||
1692396|NCT01095003|3111410|Superiority||Hazard Ratio (HR)|0.84||||0.0426|2-Sided|95.0|0.71|0.99|||Log Rank|||The final analysis of progression free survival was conducted once the required number of events(615 progressions or deaths) was reached.using the IRC assessment of date of progressions following the blinded radiological and clinical review of data. Kaplan-Meier curves and life tables by treatment arm were provided.A stratified Cox proportional model was used to compare the two treatment arms|
1692397|NCT01094886|3111411|Superiority or Other||Mean Difference (Final Values)|-35.13|Standard Deviation|36.316|<|0.001|2-Sided|95.0|-48.01|-22.26|||t-test, 2 sided||||
1692398|NCT01094886|3111412|Superiority or Other||Mean Difference (Final Values)|-0.21|Standard Deviation|6.977||0.87|2-Sided|95.0|-2.77|2.35|||t-test, 2 sided||||
1692399|NCT01094886|3111413|Superiority or Other||Mean Difference (Final Values)|-0.91|Standard Deviation|-1.1||0.111|2-Sided|95.0|-2.048|0.219|||t-test, 2 sided||||
1692400|NCT01094886|3111414|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Deviation|0.5||0.008|2-Sided|95.0|-0.05|0.34|||t-test, 2 sided||||
1692401|NCT01094808|3111415|Superiority or Other||mean value for 200 mg Pregabalin|35.301|Standard Deviation|22.295||0.12||95.0||||P-value not adjusted for multiple comparisons; alpha level of 0.05 used|ANCOVA||A confidence interval was not calculated|ANCOVA for overall treatment effects|
1692402|NCT01094808|3111416|Superiority or Other||mean value for 200 mg Pregabalin|33.391|Standard Deviation|22.106||0.14||95.0||||P-value not adjusted for multiple comparisons; alpha level of 0.05 used|ANCOVA||A confidence interval was not calculated|ANCOVA for overall treatment effects|
1692403|NCT01094548|3111462|Superiority or Other||Hazard Ratio (HR)|0.666||||0.3919|2-Sided|95.0|0.261|1.698|||Log Rank||||
1692404|NCT01094548|3111463|Superiority or Other||Hazard Ratio (HR)|0.431||||0.094|2-Sided|95.0|0.157|1.185|||Log Rank||||
1692405|NCT01094548|3111467|Superiority or Other|||||||1|||||||Fisher Exact||||
1692406|NCT01094119|3111624|Superiority|||||||0.0069|||||||Regression, Logistic||||
1692407|NCT01093755|3111632|Superiority or Other|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 6 months|
1692408|NCT01093755|3111632|Superiority or Other|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 3 months|
1692409|NCT01093755|3111633|Superiority or Other|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 6 months|
1692410|NCT01093755|3111633|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Comparison between the two treatment groups at 3 months|
1692411|NCT01093690|3111635|Superiority or Other|||||||0.41||||||No adjustment.|Chi-squared|1-sided test||the study had 80 percent power to detect an absolute difference of 20 percent in complete response (70% for metoclopramide group vs 50% for control group)|
1692412|NCT01093651|3111636|Superiority or Other||||||>|0.05||||||The a priori threshold for statistical significance was p<0.05. The non-paramteric test for adverse event cummulative frequency between the 2 groups did not achieve p<0.05 (not statistically significant)|Kruskal-Wallis|||Kruskal-Wallis non-parametric test of cell frequencies|
1692413|NCT01093651|3111637|Superiority or Other||||||<|0.04||||||The a priori threshold for statistical significance was p<0.05. The main effect analysis for area under the glucose tolerance curve over time and between the 2 groups achieved p<0.04.|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in area under the glucose tolerance curves between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.|
1692438|NCT01092663|3111770|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||differerences in treatment effect between the 2 groups|
1692439|NCT01092663|3111771|Superiority or Other||||||=|0|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692440|NCT01092663|3111772|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692414|NCT01093651|3111638|Superiority or Other||||||>|0.05||||||The a priori threshold for statistical significance was p<0.05. The main effect analysis for serum RANTES levels over time and between the 2 groups did not achieve p<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum RANTES levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.|
1692415|NCT01093651|3111639|Superiority or Other||||||<|0.0002||||||The a priori threshold for statistical significance was p<0.05. The main effect analysis for SDF1-alpha levels over time and between the 2 groups achieved p<0.0002.|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum SDF1α levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.|
1692416|NCT01093651|3111640|Superiority or Other||||||>|0.05||||||The a priori threshold for statistical significance was p<0.05. The main effect analysis for serum TNFR2 levels over time and between the 2 groups did not achieve p<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in serum TNFR2 levels between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.|
1692417|NCT01093651|3111641|Superiority or Other||||||>|0.05||||||The a priori threshold for statistical significance was p<0.05. The main effect analysis for plasma HIV RNA copy number/mL over time and between the 2 groups did not achieve p<0.05 (not statistically significant).|Mixed Models Analysis|||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in plasma HIV RNA copy number/mL between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.|
1692418|NCT01093651|3111642|Superiority or Other||||||>|0.05||||||The a priori threshold for statistical significance was p<0.05. The main effect analysis for CD4+ T-cell count over time and between the 2 groups did not achieve p<0.05 (not statistically significant).|Mixed Models Analysis|Study subject was included in these models as a random variable to account for within-participant correlation.||The main effect analysis was applied to both rows (timepoint) and categories (groups). It used linear mixed models to simultaneously assess differences in CD4+ T-cell count between the DPP4 inhibitor and placebo groups (categories) over time (rows). Pairwise post-hoc contrasts were performed to assess the between and within group differences in outcome measures at each time point.|
1692419|NCT01093534|3111700|Superiority or Other|||||||0.25||||||Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.|Wilcoxon (Mann-Whitney)|Nonparametric Wilcoxon rank-sum test does not adjust for other factors.||The null hypothesis for the co-primary treatment comparison was that the mean free (neutralized) uNGF/Cr value in the pooled solifenacin group and placebo was the same. Wilcoxon rank-sum test was used instead of a contrast from analysis of covariance (ANCOVA), because data was not normally distributed. Power was planned for 80% (assumption: mean difference = 0.74 pg/μmol, standard deviation=2.0, 220 and 110 participants, bonferroni adjustment for alpha =0.025).|
1692420|NCT01093534|3111701|Superiority or Other||Least squares mean difference|-0.169||||0.095|2-Sided|95.0|-0.368|0.03||Hochberg Method for controlling the overall risk of type I error of 5% was used to adjust for using two co-primary endpoints.|ANCOVA|ANCOVA model with fixed effects for treatment and region and Baseline of least squares mean BWT as a covariate.||The null hypothesis was that the mean change from Baseline in BWT in the pooled solifenacin group and placebo was the same. Estimated as two-sided contrast with 95% confidence interval. Power was planned for 80% (assumption: mean difference = 0.5 mm, standard deviation=1.65, 314 and 157 participants, bonferroni adjustment for alpha =0.025)|
1692421|NCT01092780|3111749|Superiority or Other||Difference in LS means|-0.07|||||2-Sided|90.0|-0.08|-0.05||||||Difference in LS means|
1692422|NCT01092780|3111750|Superiority or Other||Difference in LS means|10.21|||||2-Sided|90.0|8.49|11.92|||||||
1692423|NCT01092780|3111751|Superiority or Other||Difference in LS means|-2.1|||||2-Sided|90.0|-3.79|-0.4||||||Difference in LS means|
1692424|NCT01092780|3111751|Superiority or Other||Difference in LS means|-2.05|||||2-Sided|90.0|-3.76|-0.35||||||Difference in LS means|
1692425|NCT01092780|3111753|Superiority or Other||Difference in LS means|-0.07|||||2-Sided|95.0|-0.09|-0.05||||||Difference in LS means|
1692426|NCT01092780|3111753|Superiority or Other||Difference in LS means|-0.07|||||2-Sided|95.0|-0.1|-0.05||||||Difference in LS means|
1692427|NCT01092780|3111754|Superiority or Other||Difference in LS means|8.11|||||2-Sided|95.0|6.07|10.15||||||Difference in LS means|
1692428|NCT01092780|3111754|Superiority or Other||Difference in LS means|8.16|||||2-Sided|95.0|6.11|10.2||||||Difference in least squares (LS) means|
1692429|NCT01092663|3111761|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692430|NCT01092663|3111762|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692431|NCT01092663|3111763|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692432|NCT01092663|3111764|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692433|NCT01092663|3111765|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692434|NCT01092663|3111766|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692435|NCT01092663|3111767|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692436|NCT01092663|3111768|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692441|NCT01092663|3111773|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired ttest||Difference in treatment effect between groups was evaluated|
1692442|NCT01092663|3111774|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between groups was evaluated|
1692443|NCT01092663|3111775|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||Treament difference in fasting EGP between the 2 groups were compared.|
1692444|NCT01092663|3111776|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692445|NCT01092663|3111777|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692446|NCT01092663|3111778|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692447|NCT01092663|3111779|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effects between the 2 groups|
1692448|NCT01092663|3111780|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692449|NCT01092663|3111781|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|unpaired t-test||Difference in treatment effect between the 2 groups|
1692450|NCT01091948|3111811|Superiority or Other||Odds Ratio (OR)|1.11||||0.82|2-Sided|95.0|0.45|2.76|||Regression, Logistic|proportional odds logistic regression model|||
1692451|NCT01091948|3111812|Superiority or Other||Risk Ratio (RR)|1.01||||0.79|2-Sided|95.0|0.93|1.09|||Cochran-Mantel-Haenszel||||
1692452|NCT01091948|3111813|Superiority or Other||Risk Ratio (RR)|1.67||||0.57|2-Sided|95.0|0.28|10.2|||Cochran-Mantel-Haenszel||||
1692453|NCT01091948|3111814|Superiority or Other||Risk Ratio (RR)|1.13||||0.15|2-Sided|95.0|0.95|1.33|||Cochran-Mantel-Haenszel||||
1692454|NCT01091948|3111815|Superiority or Other||Ratio of Geometric Means|0.89||||0.58|2-Sided|95.0|0.58|1.35|||ANCOVA||The mean intubation difficulty score was tested after logarithmic transformation, and then back transformed for the estimated treatment effect.||
1692455|NCT01091948|3111816|Superiority or Other|||||||0.19|||||||Regression, Cox|Intubations accomplished with another device due to difficulty with assigned device and those took >180 s were considered as failed intubations.|||
1692456|NCT01091363|3111872|Superiority or Other|Hayes’ PROCESS computation tool for a serial multiple mediator model predicting a binary logistic outcome.|Mean Difference (Net)|1.92||||0.02|2-Sided|95.0|0.34|6.32|||Mediation Analysis|||Mediation analyses were performed to examine the effect of the intervention on abstinence via the three theoretic variables (attitudes, perceived family norms, and self-efficacy), using the Hayes’ PROCESS computation tool for a serial multiple mediator model with a binary outcome variable (quitting vs. smoking).|
1692457|NCT01091363|3111873|Superiority||Odds Ratio (OR)|4.67|||<|0.01|2-Sided|95.0|1.67|12.99|||Regression, Logistic||||
1692458|NCT01091246|3111912|Non-Inferiority or Equivalence|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% confidence intervals were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric mean|1.05|||||2-Sided|95.0|0.93|1.18||||||B/Victoria: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj > 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Victoria) / (Q/LAIV) for B/Victoria strain|
1692459|NCT01091246|3111912|Non-Inferiority or Equivalence|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% CIs were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric mean|1.21|||||2-Sided|95.0|1.07|1.37||||||B/Yamagata: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj > 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata) / (Q/LAIV) for B/Yamagata strain|
1692460|NCT01091246|3111912|Non-Inferiority or Equivalence|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5. If the upper bounds of 95% CIs were ≤ 1.5 for all 4 strains, the immunologic noninferiority of Q/LAIV compared to FluMist was declared.|Ratio of geometric means|1.04|||||2-Sided|95.0|0.94|1.14||||||A/H3N2: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj > 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata + FluMist/B/Victoria) / (Q/LAIV) for A/H3N2 strain|
1692461|NCT01091246|3111912|Non-Inferiority or Equivalence|The noninferior immune response was assessed by evaluating the upper bound of the two-sided 95% confidence intervals for the strain specific HAI antibody GMT ratios (FluMist divided by Q/LAIV) to the noninferiority margin of 1.5.|Ratio of geometric mean|1.07|||||2-Sided|95.0|0.98|1.16||||||A/H1N1: The statistical hypothesis testing for the primary endpoint for Q/LAIV was: H0: Rj > 1.5, for any j HA: Rj ≤ 1.5, for all j Where Rj was any of the 4 strain-specific post immunogenicity dose GMT ratios: (FluMist/B/Yamagata + FluMist/B/Victoria) / (Q/LAIV) for A/H1N1 strain|
1692462|NCT01091168|3111913|Superiority||Hazard Ratio (HR)|0.94||||0.4927|2-Sided|95.0|0.8|1.12|||Log Rank|||PFS was compared between the 2 treatment arms by the log-rank test procedure with the 5 % significant level, stratified on the stratification factors (except study site) as specified at the time of randomisation. Os was analysed using Kaplan-Meir method and summarized with median and 95% CI of the median|
1692463|NCT01091168|3111914|Superiority|||||||0.0424|||||||Log Rank|||The disease control rate (DCR) were compared in the ITT population and in the population evaluable for response between the 2 arms with a cochran Mantel Haenszel, stratified on WHO performance status at baseline, number of prior chemotherapy lines for the treatment of disease and disease measurability at Baseline.|
1692487|NCT01090427|3112007|Superiority or Other|||||||0.007|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.||PedsQL Physical health summary score|
1692464|NCT01091168|3111915|Superiority||Hazard Ratio (HR)|1.04||||0.673|2-Sided|95.0|0.86|1.25|||Cochran-Mantel-Haenszel|||Kaplan-Meier curves and life tables by treatment arm were provided. Confidence intervals on the median were calculated using the Brookmeyer and Crowley method. Hazard ratio and 95% confidence intervals were reported. A stratified Cox proportional model was performed to compare the two treatment arms taking into account the stratification factors (except centre) used at the time of randomisation.|
1692465|NCT01091116|3111927|Superiority or Other|||||||0.5263|||||||ANCOVA|||Tests of Fixed Effects for the primary efficacy variable including baseline treatment and visit (from Visit 3 to Visit 5) as covariates|
1692466|NCT01091103|3111938|Superiority or Other|||||||0.337||||||The p-value was not adjusted for multiplicity.|t-test, 2 sided||||
1692467|NCT01091103|3111939|Superiority or Other|||||||0.9427||||||The p-value was not adjusted for multiplicity.|t-test, 2 sided||||
1692468|NCT01090492|3111978|Superiority or Other||Adjusted Mean Difference|-0.44||||0.194|2-Sided|80.0|-0.88|-0.01|||ANCOVA|||Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692469|NCT01090492|3111978|Superiority or Other||Adjusted Mean Difference|-0.28||||0.3462|2-Sided|80.0|-0.67|0.1|||ANCOVA|||Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692470|NCT01090492|3111978|Superiority or Other||Adjusted Mean Difference|-0.77||||0.0053|2-Sided|80.0|-1.12|-0.43|||ANCOVA|||Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692471|NCT01090492|3111978|Superiority or Other||Adjusted Mean Difference|0.15||||0.5909|2-Sided|80.0|-0.21|0.52|||ANCOVA|||Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692472|NCT01090492|3111979|Superiority or Other||Adjusted Mean Difference|-1.09||||0.5497|2-Sided|80.0|-3.45|1.26|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692473|NCT01090492|3111979|Superiority or Other||Adjusted Mean Difference|-2.37||||0.1446|2-Sided|80.0|-4.44|-0.29|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692474|NCT01090492|3111979|Superiority or Other||Adjusted Mean Difference|-6.17||||0.1463|2-Sided|80.0|-11.61|-0.73|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692475|NCT01090492|3111979|Superiority or Other||Adjusted Mean Difference|1.21||||0.79|2-Sided|80.0|-4.61|7.03|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692476|NCT01090492|3111980|Superiority or Other||Adjusted Mean Difference|-1.91||||0.3524|2-Sided|80.0|-4.55|0.73|||ANCOVA|||At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692477|NCT01090492|3111980|Superiority or Other||Adjusted Mean Difference|-0.59||||0.7423|2-Sided|80.0|-2.92|1.73|||ANCOVA|||At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692478|NCT01090492|3111980|Superiority or Other||Adjusted Mean Difference|-1.35||||0.4651|2-Sided|80.0|-3.74|1.03|||ANCOVA|||At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692479|NCT01090492|3111980|Superiority or Other||Adjusted Mean Difference|0.12||||0.9504|2-Sided|80.0|-2.43|2.68|||ANCOVA|||At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692480|NCT01090492|3111981|Superiority or Other||Adjusted Mean Difference|-0.15||||0.6286|2-Sided|80.0|-0.56|0.25|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692481|NCT01090492|3111981|Superiority or Other||Adjusted Mean Difference|-0.44||||0.1157|2-Sided|80.0|-0.8|-0.08|||ANCOVA|||SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692482|NCT01090492|3111981|Superiority or Other||Adjusted Mean Difference|-0.69||||0.0057|2-Sided|80.0|-0.99|-0.38|||ANCOVA|||PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692483|NCT01090492|3111981|Superiority or Other||Adjusted Mean Difference|0.11||||0.6513|2-Sided|80.0|-0.21|0.44|||ANCOVA|||PRP: Adjusted mean difference analysis was based on Analysis of Covariance (ANCOVA) model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.|
1692484|NCT01090427|3112006|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).|||
1692485|NCT01090427|3112006|Superiority or Other||||||<|0.027|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).|||
1692486|NCT01090427|3112007|Superiority or Other|||||||0.02|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.||PedsQL Physical health summary score|
1692488|NCT01090427|3112007|Superiority or Other|||||||0.063|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.||PedsQL Psychosocial health summary score|
1692489|NCT01090427|3112007|Superiority or Other|||||||0.005|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.||PedsQL Psychosocial health summary score|
1692490|NCT01090427|3112007|Superiority or Other|||||||0.028|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.||PedsQL Total Scale Score|
1692491|NCT01090427|3112007|Superiority or Other|||||||0.003|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] were used as factors in the model.||PedsQL Total Scale Score|
1692492|NCT01090427|3112008|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||Participants with PASI score of 0|
1692493|NCT01090427|3112008|Superiority or Other||||||<|0.014|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||Participants with PASI score of 0|
1692494|NCT01090427|3112008|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PASI 50 responders|
1692495|NCT01090427|3112008|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PASI 50 responders|
1692496|NCT01090427|3112009|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0, 1, or 2|
1692497|NCT01090427|3112009|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0, 1, or 2|
1692498|NCT01090427|3112009|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0|
1692499|NCT01090427|3112009|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).||PGA of 0|
1692500|NCT01090427|3112010|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).|||
1692501|NCT01090427|3112010|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).|||
1692502|NCT01090427|3112011|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] will be used as factors in the model.|||
1692503|NCT01090427|3112011|Superiority or Other||||||<|0.003|||||||ANOVA on van der Waerden normal Score|Treatment and baseline weight [less than or equal to 60 kg vs greater than 60 kg] will be used as factors in the model.|||
1692504|NCT01090427|3112012|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).|||
1692505|NCT01090427|3112012|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).|||
1692506|NCT01090427|3112013|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).|||
1692507|NCT01090427|3112013|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by body weight (less than or equal to 60 kg vs greater than 60 kg).|||
1692508|NCT01090102|3112029|Superiority or Other|||||||0.77||||||significant at p<0.05|t-test, 2 sided||||
1692509|NCT01090102|3112030|Superiority or Other|||||||0.63||||||Significant at p<0.05|t-test, 2 sided||||
1692510|NCT01090076|3112031|Superiority or Other|||||||0.44|||||||t-test, 2 sided||||
1692511|NCT01090076|3112032|Superiority or Other|||||||0.877|||||||t-test, 2 sided||||
1692512|NCT01090076|3112033|Superiority or Other|||||||0.023|||||||t-test, 2 sided||||
1692513|NCT01089647|3112077|Other||||||=|0|||||||ANOVA|||Between-group comparisons at follow-up were made using a stepwise multivariable logistic model.|
1692514|NCT01089608|3112078|Superiority or Other||Mean Difference (Net)|-8.01||||0.072|2-Sided|95.0|-16.3|0.28|||Mixed Models Analysis||||
1692515|NCT01089582|3112084|Superiority or Other||||||<|0.0001|||||||Regression, Linear|||The effect of possible prognostic factors on response: center number.|
1692516|NCT01089582|3112084|Superiority or Other||||||<|0.0001|||||||Regression, Linear|||The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by caregiver.|
1692517|NCT01089582|3112084|Superiority or Other||||||<|0.0137|||||||Regression, Linear|||The effect of possible prognostic factors on response: primary diagnosis severity.|
1692518|NCT01089582|3112085|Superiority or Other||||||<|0.0001|||||||Regression, Linear|||The effect of possible prognostic factors on response: center number.|
1692519|NCT01089582|3112085|Superiority or Other||||||<|0.0001|||||||Regression, Linear|||The effect of possible prognostic factors on response: baseline QoL-AD score as assessed by participant.|
1692520|NCT01089582|3112085|Superiority or Other||||||<|0.1805|||||||Regression, Linear|||The effect of possible prognostic factors on response: primary diagnosis severity.|
1692521|NCT01089582|3112086|Superiority or Other|||||||0.0382|||||||Regression, Logistic|||The effect of possible prognostic factors on response: significant medical history. Participants were classified as responders if they were much improved or improved from baseline.|
1692522|NCT01089582|3112087|Superiority or Other|||||||0.0023|||||||Regression, Logistic|||The effect of possible prognostic factors response on response rate: primary diagnosis severity. Participants were classified as responders if they were very much improved or much improved from baseline.|
1692523|NCT01089556|3112095|Superiority or Other|||||||1|||||||Fisher Exact||||
1692524|NCT01089556|3112096|Superiority or Other|||||||0.744|||||||Fisher Exact||||
1692525|NCT01089556|3112097|Superiority or Other|||||||0.571|||||||Fisher Exact||||
1692526|NCT01089556|3112098|Superiority or Other|||||||0.618|||||||Fisher Exact||||
1692527|NCT01089556|3112099|Superiority or Other||LS Mean Difference (Final Values)|-0.942||||0.332||95.0|||||ANCOVA||||
1692529|NCT01089556|3112101|Superiority or Other||LS Mean Difference (Final Values)|-0.003||||0.997||95.0||||P-value is for diastolic BP.|ANCOVA||||
1692530|NCT01089556|3112101|Superiority or Other||LS Mean Difference (Final Values)|-1.329||||0.354||95.0||||P-value is for systolic BP.|ANCOVA||||
1692531|NCT01089556|3112102|Superiority or Other||LS Mean Difference (Final Values)|0.135||||0.843||95.0||||P-value is for diastolic BP.|ANCOVA||||
1692532|NCT01089556|3112102|Superiority or Other||LS Mean Difference (Final Values)|-2.02||||0.064||95.0||||P-value is for systolic BP.|ANCOVA||||
1692533|NCT01089556|3112103|Superiority or Other||LS Mean Difference (Final Values)|-0.095||||0.385||95.0|||||Mixed Models Analysis||||
1692534|NCT01089556|3112104|Superiority or Other||LS Mean Difference (Final Values)|-0.343|||<|0.001||95.0|||||Mixed Models Analysis||||
1692535|NCT01089556|3112109|Superiority or Other||LS Mean Difference (Final Values)|-0.378||||0.198||95.0||||P-value is for depression subscale score.|Mixed Models Analysis||||
1692536|NCT01089556|3112109|Superiority or Other||LS Mean Difference (Final Values)|-0.615||||0.049||95.0||||P-value is for anxiety subscale score.|Mixed Models Analysis||||
1692537|NCT01089556|3112110|Superiority or Other||LS Mean Difference (Final Values)|-0.423||||0.031||95.0||||p-value is for depression subscale score.|Mixed Models Analysis||||
1692538|NCT01089556|3112110|Superiority or Other||LS Mean Difference (Final Values)|-0.558||||0.008||95.0||||P-value is for anxiety subscale score.|Mixed Models Analysis||||
1692539|NCT01089556|3112111|Superiority or Other||LS Mean Difference (Final Values)|-0.193||||0.78||95.0|||||ANCOVA||||
1692540|NCT01089556|3112112|Superiority or Other||LS Mean Difference (Final Values)|-1.02||||0.071||95.0|||||ANCOVA||||
1692541|NCT01089556|3112113|Superiority or Other||LS Mean Difference (Final Values)|-1.933||||0.289||95.0|||||Mixed Models Analysis||||
1692542|NCT01089556|3112114|Superiority or Other||LS Mean Difference (Final Values)|-4.758|||<|0.001||95.0|||||Mixed Models Analysis||||
1692543|NCT01089556|3112115|Superiority or Other||LS Mean Difference (Final Values)|-0.073||||0.475||95.0|||||Mixed Models Analysis||||
1692544|NCT01089556|3112116|Superiority or Other||LS Mean Difference (Final Values)|-0.341|||<|0.001||95.0|||||Mixed Models Analysis||||
1692545|NCT01089556|3112117|Superiority or Other||Risk Ratio (RR)|0.985||||0.843|2-Sided|95.0|0.842|1.151|||Cochran-Mantel-Haenszel||||
1692546|NCT01089556|3112118|Superiority or Other||Risk Ratio (RR)|1.279|||<|0.001|2-Sided|95.0|1.125|1.456|||Cochran-Mantel-Haenszel||||
1692547|NCT01089556|3112119|Superiority or Other||Risk Ratio (RR)|1.233||||0.068|2-Sided|95.0|0.98|1.55|||Cochran-Mantel-Haenszel||||
1692548|NCT01089556|3112120|Superiority or Other||Risk Ratio (RR)|1.467|||<|0.001|2-Sided|95.0|1.214|1.771|||Cochran-Mantel-Haenszel||||
1692549|NCT01089556|3112121|Superiority or Other||Risk Ratio (RR)|1.052||||0.565|2-Sided|95.0|0.884|1.253|||Cochran-Mantel-Haenszel||||
1692550|NCT01089556|3112122|Superiority or Other||Risk Ratio (RR)|1.431|||<|0.001|2-Sided|95.0|1.233|1.662|||Cochran-Mantel-Haenszel||||
1692551|NCT01089556|3112123|Superiority or Other||LS Mean Differences (Final Values)|-0.003||||0.991||95.0|||||Mixed Models Analysis||||
1692552|NCT01089556|3112124|Superiority or Other||LS Mean Differences (Final Values)|-0.614|||<|0.001||95.0|||||Mixed Models Analysis||||
1692553|NCT01089556|3112125|Superiority or Other||LS Mean Differences (Final Values)|-0.192||||0.37||95.0|||||Mixed Models Analysis||||
1692554|NCT01089413|3112136|Superiority or Other||Hazard Ratio (HR)|0.6||||0.1555|2-Sided|95.0|0.3|1.21|||Regression, Cox||||
1692555|NCT01089413|3112137|Superiority or Other||Hazard Ratio (HR)|1.04||||0.8579|2-Sided|95.0|0.7|1.54|||Regression, Cox||||
1692556|NCT01089023|3112156|Superiority or Other||||||<|0.0001||||||p-value measures the significance between each visit using analysis of variance|ANOVA||||
1692557|NCT01089023|3112157|Superiority or Other||||||<|0.0001||||||p-value measures the significance between each visit using analysis of variance|ANOVA||||
1692558|NCT01088984|3112175|Superiority or Other|||||||1||||||1-sided p-value is calculated against the null hypothesis of a response rate of 5%.|binomial parameter exact method||||
1692559|NCT01088711|3112184|Superiority or Other||Ratio of geometric least-squares means|0.91|||||2-Sided|90.0|0.72|1.17|||||GMR is ratio of total GLP-1 levels in omarigliptin:placebo groups.||
1692560|NCT01088711|3112185|Superiority or Other||Ratio of geometric least-squares means|1.92|||||2-Sided|90.0|1.55|2.38|||||GMR is ratio of active GLP-1 levels in omarigliptin:placebo groups.||
1692561|NCT01088711|3112187|Superiority or Other||Mean Difference (Final Values)|90.76|||||2-Sided|90.0|82.7|99.37|||||||
1692562|NCT01088529|3112195|Superiority or Other||Relative risk|6.523|||<|0.0001|2-Sided|90.0|2.701|15.753|||Chi-squared||||
1692563|NCT01088529|3112196|Superiority or Other||Relative risk|0.477||||0.1796|2-Sided|90.0|0.205|1.109|||Fisher Exact||||
1692564|NCT01088529|3112197|Superiority or Other||Relative risk|1.432||||0.2148|2-Sided|90.0|0.859|2.386|||Chi-squared||||
1692565|NCT01088503|3112198|Superiority or Other||Odds Ratio (OR)|1.005|||||2-Sided||||||||Odds Ratio for selection of Prasugrel for participants with Duke CAD Index vs no Duke CAD Index.||
1692566|NCT01088503|3112199|Superiority or Other||Odds Ratio (OR)|1.05|||||2-Sided||||||||Odds Ratio for selection of Prasugrel for participants who had pre-procedure hemoglobin evaluation vs no hemoglobin evaluation.||
1692567|NCT01088503|3112203|Superiority or Other||Hazard Ratio (HR)|0.967|||||2-Sided|95.0|0.849|1.103|||||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.||
1692568|NCT01088503|3112204|Superiority or Other||Hazard Ratio (HR)|1.3||||0.1882|2-Sided|95.0|0.88|1.93||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|Log Rank||Hazard ratio (HR) is for the analysis at 12 months.||
1692569|NCT01088503|3112205|Superiority or Other||Odds Ratio (OR)|1.172|||||2-Sided||||||||Odds Ratio for selection of Prasugrel for participants with no BMS or DES placement vs BMS.||
1692570|NCT01088503|3112205|Superiority or Other||Odds Ratio (OR)|1.125|||||2-Sided||||||||Odds Ratio for selection of Prasugrel for participants who had diabetes vs no diabetes.||
1692571|NCT01088503|3112205|Superiority or Other||Odds Ratio (OR)|1.116|||||2-Sided||||||||Odds Ratio for selection of Prasugrel for participants who were married vs not married.||
1692572|NCT01088503|3112205|Superiority or Other||Odds Ratio (OR)|1.12|||||2-Sided||||||||Odds Ratio for selection of Prasugrel for participants with EQ-5D US index = 1 vs. <1.||
1692573|NCT01088503|3112205|Superiority or Other||Odds Ratio (OR)|1.195|||||2-Sided||||||||Odds Ratio for selection of Prasugrel for participants who were male vs not male.||
1692574|NCT01088503|3112205|Superiority or Other||Odds Ratio, log|1.684|||||2-Sided||||||||Odds Ratio for selection of Prasugrel for participants who had cardiogenic shock within 24 hours vs no cardiogenic shock within 24 hours.||
1692575|NCT01088503|3112205|Superiority or Other||Odds Ratio, log|1.657|||||2-Sided||||||||Odds Ratio for selection of Prasugrel for participants who were Other Race vs Caucasian.||
1692576|NCT01088503|3112205|Superiority or Other||Odds Ratio (OR)|1.23|||||2-Sided||||||||Odds Ratio for selection of Prasugrel for participants with STEMI vs not STEMI||
1692577|NCT01088503|3112205|Superiority or Other||Odds Ratio (OR)|1.464|||||2-Sided||||||||Odds Ratio for selection of Prasugrel for participants with DES vs BMS.||
1692578|NCT01088503|3112206|Superiority or Other||Hazard Ratio (HR)|1.03||||0.7108|2-Sided|95.0|0.88|1.22||Statistical analysis adjusted for the differences in baseline characteristics between participants treated with prasugrel vs. clopidogrel using propensity scoring.|Log Rank||||
1692579|NCT01088438|3112222|Superiority or Other|||||||0.85|||||||Chi-squared|1 df||Null hypothesis is equal proportion of encounters probed in control and intervention groups.|
1692580|NCT01088438|3112223|Superiority or Other||||||<|0.001|||||||Chi-squared|1 degree of freedom||Null hypothesis is equal proportion of contextual red flags probed in control and intervention groups.|
1692581|NCT01088438|3112224|Superiority or Other||||||<|0.001|||||||Chi-squared|1 degree of freedom||Null hypothesis: proportion of encounters with contextual red flag in which appropriate treatment is planned is the same in the two groups.|
1692582|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|0.0|||||2-Sided|95.0|0.0|63.97||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown T2DM."|
1692583|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|3.0|||||2-Sided|95.0|0.08|16.7||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other T2DM."|
1692584|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|7.9|||||2-Sided|95.0|0.96|28.52||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA T2DM."|
1692585|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|0.0|||||2-Sided|95.0|0.0|31.16||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D T2DM."|
1692586|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|0.0|||||2-Sided|95.0|0.0|7.52||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS T2DM."|
1692587|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|6.46|||||2-Sided|95.0|1.33|18.89||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS T2DM."|
1692588|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|3.93|||||2-Sided|95.0|2.03|6.87||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD T2DM."|
1692589|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|3.79|||||2-Sided|95.0|2.24|5.96||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All T2 DM."|
1692590|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio]|0.0|||||2-Sided|95.0|0.0|14.84||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown T1DM."|
1692591|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio]|2.09|||||2-Sided|95.0|0.43|6.1||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other T1DM."|
1692592|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|0.0|||||2-Sided|95.0|0.0|3.38||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA T1DM."|
1692593|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|0.0|||||2-Sided|95.0|0.0|7.23||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D T1DM."|
1692594|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|1.42|||||2-Sided|95.0|0.29|4.14||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS T1DM."|
1692595|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|1.5|||||2-Sided|95.0|0.31|4.38||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS T1DM."|
1692596|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|0.76|||||2-Sided|95.0|0.36|1.4||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD T1DM."|
1692597|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|0.92|||||2-Sided|95.0|0.56|1.44||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All T1 DM."|
1696413|NCT01033942|3118854|Superiority or Other|||||||0.3176|||||||Fisher Exact||||
1692598|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|0.0|||||2-Sided|95.0|0.0|24.3||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Unknown DM (T1, T2 and DM NOS Combined)"|
1692599|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|4.55|||||2-Sided|95.0|1.24|11.66||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for Other DM (T1, T2 and DM NOS Combined)"|
1692600|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|3.0|||||2-Sided|95.0|0.36|10.83||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SGA DM (T1, T2 and DM NOS Combined)"|
1692601|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|0.0|||||2-Sided|95.0|0.0|11.83||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for SHOX-D DM (T1, T2 and DM NOS Combined)"|
1692602|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|3.1|||||2-Sided|95.0|0.84|7.93||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for ISS DM (T1, T2 and DM NOS Combined)"|
1692603|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|4.91|||||2-Sided|95.0|1.8|10.69||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for TS DM (T1, T2 and DM NOS Combined)"|
1692604|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|2.74|||||2-Sided|95.0|1.72|4.15||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for GHD DM (T1, T2 and DM NOS Combined)"|
1692605|NCT01088412|3112225|Superiority or Other||Standardized Incidence Ratio|3.03|||||2-Sided|95.0|2.14|4.15||||||"Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.~Standardized Incidence Ratio for All DM (T1, T2 and DM Not Otherwise Specified [NOS] Combined)"|
1692606|NCT01088412|3112232|Superiority or Other||Standardized Incidence Ratio|0.71|||||2-Sided|95.0|0.39|1.2||||||Epidemiological comparison between incidence of primary malignancies in study versus general population registry data, stratified by age and gender.|
1692607|NCT01088412|3112233|Superiority or Other||Standardized Incidence Ratio|3.77|||||2-Sided|95.0|2.24|5.96||||||Epidemiological comparison between incidence of type 2 diabetes in study versus general population registry data, stratified by age and ethnicity.|
1692608|NCT01087996|3112249|Superiority or Other|||||||0.55|||||||Chi-squared||||
1692609|NCT01087996|3112250|Superiority or Other|||||||0.84|||||||Repeated measures ANOVA||||
1692610|NCT01087996|3112251|Superiority or Other|||||||0.87|||||||Repeated measures ANOVA||||
1692611|NCT01087996|3112252|Superiority or Other||||||>|0.05|||||||ANOVA||||
1692612|NCT01087996|3112253|Superiority or Other||||||>|0.05|||||||ANOVA||||
1692613|NCT01087996|3112254|Superiority or Other||||||>|0.05|||||||ANOVA||||
1692614|NCT01087996|3112255|Superiority or Other||||||>|0.05|||||||ANOVA||||
1692615|NCT01087996|3112256|Superiority or Other|||||||0.75|||||||ANOVA||||
1692616|NCT01087996|3112257|Superiority or Other|||||||1|||||||Fisher Exact||||
1692617|NCT01087905|3112302|Superiority or Other||Incremental cost-effectiveness ratio|1290.0||||||95.0||||||||In this analysis, the Incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch and nicotine gum = (348-178)/(.516-.384) = $1290.|
1692618|NCT01087905|3112302|Superiority or Other||Incremental cost-effectiveness ratio|712.0||||||95.0||||||||In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 6 weeks of nicotine patch only = (233-178)/(.462-.384) = $712.|
1692619|NCT01087905|3112302|Superiority or Other||incremental cost-effectiveness ratio|357.0||||||95.0||||||||In this analysis, the incremental cost-effectiveness ratio (ICER) is computed. ICER is a measure of the added cost per added quit for two treatments. ICER was computed as the cost difference between the least intensive treatment group (2 weeks of nicotine patch only) and a more intensive comparison group divided by the difference in the quit rates of the two groups being compared; ICER for the group that received 2 weeks of nicotine patch and nicotine gum = (213-178)/(.482-.384) = $357.|
1692620|NCT01087905|3112303|Superiority or Other||Odds Ratio (OR)|1.71||||0.003|2-Sided|95.0|1.2|2.45|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Six Weeks of Combination NRT (Patch+Gum). We hypothesized that Six Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."|
1692621|NCT01087905|3112303|Superiority or Other||Odds Ratio (OR)|1.38||||0.079|2-Sided|95.0|0.96|1.97|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus SIx Weeks of NRT Monotherapy. We hypothesized that Six Weeks of NRT Monotherapy would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."|
1692622|NCT01087905|3112303|Superiority or Other||Odds Ratio (OR)|1.49||||0.029|2-Sided|95.0|1.04|2.14|||Regression, Logistic||Inclusion of the Cognitive Medication Adherence Counseling (CMAC) factor (No CMAC versus CMAC) as a control variable did not change the results of this analysis.|"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) Monotherapy (Nicotine Patch Only) versus Two Weeks of Combination NRT (Patch+Gum). We hypothesized that Two Weeks of Combination NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention."|
1692623|NCT01087905|3112304|Superiority or Other||Odds Ratio (OR)|0.89||||0.343|2-Sided|95.0|0.69|1.14|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving Standard Cessation Counseling (No CMAC) versus Standard Cessation Counseling plus CMAC. We hypothesized that Standard Counseling plus CMAC would result in statistically significantly higher abstinence rates compared to Standard Counseling Only.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Standard Counseling plus CMAC)."|
1692624|NCT01087905|3112304|Superiority or Other||Odds Ratio (OR)|1.36||||0.017|2-Sided|95.0|1.06|1.75|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving NRT Monotherapy (Nicotine Patch Only) versus NRT Combination Therapy (Nicotine Patch plus Nicotine Gum). We hypothesized that Combination NRT would result in statistically significantly higher abstinence rates compared to NRT Monotherapy.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., Combination NRT)."|
1692625|NCT01087905|3112304|Superiority or Other||Odds Ratio (OR)|1.26||||0.076|2-Sided|95.0|0.98|1.61|||Regression, Logistic|||"Null hypothesis: No difference in abstinence rates for participants receiving Two Weeks of Nicotine Replacement Therapy (NRT) versus Six Weeks of Nicotine Replacement Therapy (NRT). We hypothesized that Six Weeks of NRT would result in statistically significantly higher abstinence rates compared to Two Weeks of NRT.~The study was originally powered to detect at least a 6.4% increase in the abstinence rate due to an enhanced intervention (e.g., 6 wks NRT)."|
1692626|NCT01087788|3112308|Superiority or Other||Least Square Mean Difference (Net)|-0.52|Standard Error of the Mean|0.26|=|0|2-Sided|95.0|-1.04|-0.01||Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the post-hoc analysis for the subgroup 'Baseline mTSS > 6'.|
1692627|NCT01087788|3112308|Superiority or Other||Least Square Mean Difference (Net)|-0.19|Standard Error of the Mean|0.12|=|0|2-Sided|95.0|-0.43|0.05||Difference of CZP 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the predefined analysis.|
1692628|NCT01087788|3112309|Superiority or Other||Difference in Percentages|46.3|||<|0.001|2-Sided|95.0|35.7|56.9||Difference of Certolizumab Pegol 200 mg + 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692629|NCT01087788|3112310|Superiority or Other||Least Square Mean Difference (Net)|-0.31|Standard Error of the Mean|0.06|<|0.001|2-Sided|95.0|-0.42|-0.2||Difference of CZP 200 mg + 400 mg vs. Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline HAQ-DI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692630|NCT01087788|3112311|Superiority or Other||Difference in Percentages|32.8|||<|0.001|2-Sided|95.0|21.8|43.8||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692631|NCT01087788|3112311|Superiority or Other||Difference in Percentages|40.2|||<|0.001|2-Sided|95.0|29.5|51.0||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692656|NCT01087502|3112353|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.09|<|0.0001||95.0|-0.6|-0.24|||ANCOVA||||
1692657|NCT01086475|3112382|Superiority or Other|||||||0.048|||||||t-test, 2 sided||||
1692658|NCT01086475|3112383|Superiority or Other|||||||0.927|||||||Chi-squared||||
1692632|NCT01087788|3112312|Superiority or Other||Least Square Mean Difference (Net)|-0.1|Standard Error of the Mean|0.09|=|0|2-Sided|95.0|-0.27|0.07||Difference of CZP 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)|
1692633|NCT01087788|3112312|Superiority or Other||Least Square Mean Difference (Net)|-0.21|Standard Error of the Mean|0.09|=|0|2-Sided|95.0|-0.38|-0.04||Difference of CZP 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior TNF-antagonist exposure as factors and Baseline mTSS score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints.Conditional on the 1st test being significant, the 2nd hypothesis was tested with the same alpha level of 5%. Stat. testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected Re-analysis approach, restricted to subjects in the RS who have at least 2 x-ray values at scheduled visits (at least 8 wks apart)|
1692634|NCT01087788|3112312|Superiority or Other||Least Square Mean Difference (Net)|-10.64|Standard Error of the Mean|8.35|=|0|2-Sided|95.0|-27.05|5.77||Diff. of CZP 200mg+400mg versus PBO (and corresponding 95% Confidence Interval and p-value) were estimated using an ANCOVA model with treatment, region and prior Tumor Necrosis Factor(TNF)-antagonist exposure as factors & BL mTSS score as a covariate|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected. This is the pre-defined primary analysis.|
1692635|NCT01087788|3112313|Superiority or Other||Difference in Percentages|27.6|||<|0.001|2-Sided|95.0|16.5|38.7||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692636|NCT01087788|3112313|Superiority or Other||Difference in Percentages|33.7|||<|0.001|2-Sided|95.0|22.8|44.6||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692637|NCT01087762|3112318|Superiority or Other||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|-0.66|-0.23||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692638|NCT01087762|3112319|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.6|-0.2||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASMI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692639|NCT01087762|3112320|Superiority or Other||Mean Difference (Final Values)|-1.99|Standard Error of the Mean|0.25|<|0.001|2-Sided|95.0|-2.49|-1.5||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692640|NCT01087762|3112321|Superiority or Other||Mean Difference (Final Values)|-1.6|Standard Error of the Mean|0.24|<|0.001|2-Sided|95.0|-2.07|-1.12||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASDAI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692659|NCT01086475|3112384|Superiority or Other|||||||0.45|||||||t-test, 2 sided||||
1692707|NCT01084005|3112753|Superiority or Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.08|<|0.0001||95.0|-0.77|-0.47|||ANCOVA||||
1692708|NCT01084005|3112754|Superiority or Other||Mean Difference (Final Values)|-0.57|Standard Error of the Mean|0.07|<|0.0001||95.0|-0.71|-0.43|||ANCOVA||||
1692709|NCT01084005|3112755|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.05|<|0.0001||95.0|-0.45|-0.24|||ANCOVA||||
1692641|NCT01087762|3112322|Superiority or Other||Mean Difference (Final Values)|-1.88|Standard Error of the Mean|0.25|<|0.001|2-Sided|95.0|-2.38|-1.38||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692642|NCT01087762|3112323|Superiority or Other||Mean Difference (Final Values)|-1.49|Standard Error of the Mean|0.24|<|0.001|2-Sided|95.0|-1.96|-1.01||Difference of CZP 200 mg + 400 mg vs. Placebo was estimated using an ANCOVA model with treatment, region, modified New York criteria and prior TNF-antagonist exposure as factors and Baseline BASFI score as a covariate.|ANCOVA|||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692643|NCT01087762|3112324|Superiority or Other||Mean Difference (Final Values)|41.1|||<|0.001|2-Sided|95.0|28.9|53.3||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692644|NCT01087762|3112324|Superiority or Other||Mean Difference (Final Values)|37.7|||<|0.001|2-Sided|95.0|25.4|50.0||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692645|NCT01087762|3112325|Superiority or Other||Mean Difference (Final Values)|25.2|||<|0.001|2-Sided|95.0|12.3|38.2||Difference of Certolizumab Pegol 400 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692646|NCT01087762|3112325|Superiority or Other||Mean Difference (Final Values)|19.3|||=|0|2-Sided|95.0|6.3|32.4||Difference of Certolizumab Pegol 200 mg versus Placebo (and corresponding 95 % Confidence Interval and p-value) were estimated using a standard two-sided Wald asymptotic test with a 5 % alpha level.|Wald-test, 2-sided|Wald test and Confidence Interval (CI) calculation were performed without continuity correction.||A hierarchical test procedure was applied to protect the overall significance level for the multiplicity of dose groups and endpoints. Conditional on the first test being significant, the second hypothesis was tested with the same alpha level of 5 %. Statistical testing for the following hypotheses was performed only if the previous null hypothesis in the hierarchy was rejected.|
1692647|NCT01087736|3112326|Superiority or Other|||||||0|||||||Other|||There was not a pre hoc hypothesis regarding change within placebo group. We only examined within group change in the topiramate condition.|
1692648|NCT01087736|3112326|Superiority or Other||||||<|0.026|||||||Mixed Models Analysis|||We planned to explore the efficacy of topiramate in reducing PTSD symptom severity. We used random-intercept linear mixed models to explore the efficacy for topiramate related reduction in PTSD symptomatology. We looked for an effect of week within TOP. Baseline scores for PTSD symptoms were used as covariates in group comparisons. All analyses were intent-to-treat and used all observations from all weeks.|
1692649|NCT01087736|3112327|Superiority or Other||Incidence Rate Ratio (IRR)|0.38||||0.036|2-Sided|95.0|0.15|0.94|||Negative binomial model|||"A secondary analysis was powered to detect a Signal or statistical trend (p<0.10) for a difference between the topiramate and placebo condition. We compared percent drinking days per week between groups averaged over the active phase of the trial (weeks 1-12). The negative binomial model included fixed effect for week, treatment group, and the interaction between treatment group and week. We covaried for baseline %DD averages to control for prestudy and study enrollment effects."|
1692650|NCT01087736|3112327|Superiority or Other|||||||0|||||||Other|||There were no pre hoc hypothesis regarding change within placebo group. We were only tested change within the topiramate condition.|
1692651|NCT01087736|3112327|Superiority or Other||Incidence Rate Ratio (IRR)|0.89||||0.019|2-Sided|95.0|0.89|0.98||We tested our Primary hypothesis with a random-intercept repeated subject negative binomial model, modeling week (baseline - week 12) as a continuous variable. All analyses were intent-to-treat and used all observations from all weeks.|negative binomial regression|||Our primary protocol-defined analysis was to examine the within-group efficacy of topiramate to reduce percent drinking days (%DD).|
1692652|NCT01087723|3112336|Superiority or Other||Relative risk|0.6||||0.0014|2-Sided|95.0|0.43|0.82|||Chi-squared||||
1692653|NCT01087541|3112337|Superiority or Other||Mean Difference (Final Values)|5.0|Standard Deviation|5.0|<|0.001|2-Sided|95.0|2.0|15.0|||t-test, 2 sided||||
1692654|NCT01087541|3112339|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Deviation|0.5|<|0.01||95.0|0.0|1.0|||t-test, 2 sided||||
1692655|NCT01087502|3112351|Superiority or Other||Mean Difference (Final Values)|-9.29|Standard Error of the Mean|6.59||0.1602||95.0|-22.28|3.7|||ANCOVA||||
1692660|NCT01086423|3112393|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-0.67|||||2-Sided|95.0|-4.6|3.04||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRN antigens, one month after the third vaccine dose.|
1692661|NCT01086423|3112393|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference [Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-2.7|||||2-Sided|95.0|-6.75|-0.11||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-FHA antigens, one month after the third vaccine dose.|
1692662|NCT01086423|3112393|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference [Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-0.68|||||2-Sided|95.0|-3.74|1.89||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PT antigens, one month after the third vaccine dose.|
1692663|NCT01086423|3112394|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference [Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 3 antibodies, one month after the third vaccine dose.|
1692664|NCT01086423|3112394|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference [Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 2 antibodies, one month after the third vaccine dose.|
1692665|NCT01086423|3112394|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference [Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-2.51|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 1 antibodies, one month after the third vaccine dose.|
1692666|NCT01086423|3112395|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference [Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|-7.93|||||2-Sided|95.0|-14.44|-2.13||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRP antibodies, one month after the third vaccine dose.|
1692667|NCT01086423|3112396|Non-Inferiority|Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference [Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-2.56|2.56||||||To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-T, one month after the third vaccine dose.|
1692668|NCT01086423|3112396|Non-Inferiority|Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group] in percentage of seroprotected subjects ≤ 10%.|Difference in seroprotection rate|0.68|||||2-Sided|95.0|-1.88|3.76||||||To demonstrate that the immunogenicity of Infanrix™ -IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-D, one month after the third vaccine dose.|
1692669|NCT01086410|3112418|Superiority or Other||Ratio of least square gometric mean|0.34|||||2-Sided|95.0|0.28|0.41|||||Analysis performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.||
1692670|NCT01086410|3112418|Superiority or Other||Ratio of least square gometric mean|0.97|||||2-Sided|95.0|0.86|1.1|||||Analysis was performed using ANCOVA with covariates of region, sex, age, treatment, and the log of the Baseline values.||
1692671|NCT01086410|3112418|Superiority or Other||Ratio of least square gometric mean|0.99|||||2-Sided|95.0|0.87|1.12|||||Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of region, sex, age, treatment, and the log of the Baseline values.||
1692672|NCT01086384|3112421|Superiority or Other||Cox Proportional Hazard|12.8||||0.036|2-Sided|95.0|10.7|14.9||P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|Regression, Cox||The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF/VI 100/25 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.||
1692706|NCT01084005|3112752|Superiority or Other||Mean Difference (Final Values)|-20.7|Standard Error of the Mean|4.8|<|0.0001||95.0|-30.2|-11.2|||ANCOVA||||
1696414|NCT01033942|3118855|Superiority or Other|||||||0.0356|||||||Fisher Exact||||
1692673|NCT01086384|3112421|Superiority or Other||Hazard Ratio (HR)|15.9||||0.036|2-Sided|95.0|13.5|18.2||P-value for the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.|Regression, Cox||The estimated value represents the adjusted probability of 1 or more severe asthma exacerbations by Week 52 for FF 100 µg. Cox Proportional Hazards Model estimate at mean Baseline FEV1, age, and proportional coefficients for sex and region.||
1692674|NCT01086384|3112421|Superiority or Other||Regression Cox|0.795|||||2-Sided|95.0|0.642|0.985|||||The estimated values is the Hazard ratio obtained from the Cox regression analysis for FF/VI 100/25 µg versus FF 100 µg, adjusted for an interim analysis.||
1692675|NCT01086358|3112422|Superiority||Odds Ratio (OR)|2.89||||0.016|2-Sided|95.0|1.22|6.84|||Regression, Logistic|As noted above, results are adjusted for study period and treatment order.||Logistic regression models with generalized estimating equations were used. In these models, a logit link function was used for a favorable response (yes/no) with treatment as the primary fixed effect and including study period and treatment order as other fixed effects..|
1692676|NCT01086358|3112423|Superiority||Mean Difference (Final Values)|-0.68||||0.059|2-Sided|95.0|-1.39|0.03|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order.||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.|
1692677|NCT01086358|3112424|Superiority||Mean Difference (Final Values)|-1.03||||0.01|2-Sided|95.0|-1.79|-0.27|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.|
1692678|NCT01086358|3112425|Superiority||Mean Difference (Final Values)|-1.71||||0.007|2-Sided|95.0|-2.92|-0.49|||Mixed Models Analysis|As noted above, results are adjusted for study period and treatment order||Analysis is a superiority comparison based on the use of linear mixed effect model with subject as a random effect, with treatment as the primary fixed effect and including study period and treatment order as other fixed effects.|
1692679|NCT01086215|3112479|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion >0|||
1692680|NCT01086215|3112479|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion >0|||
1692681|NCT01086215|3112479|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion >0|||
1692682|NCT01086215|3112479|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion >0|||
1692683|NCT01085825|3112496|Superiority or Other|||||||0.13|||||||Chi-squared||||
1692684|NCT01085630|3112516|Superiority|||||||0.2423|||||||Fisher Exact||||
1692685|NCT01085318|3112562|Superiority or Other||Median Difference (Final Values)|644.99|||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1692686|NCT01085318|3112563|Superiority or Other||Median Difference (Final Values)|864.1||||0.061|||||||Wilcoxon (Mann-Whitney)||||
1692687|NCT01085136|3112574|Superiority or Other||Odds Ratio (OR)|2.98||||0.0065|2-Sided|95.0|1.357|6.543|||Regression, Logistic|||Odds ratio, 95% Confidence Interval (CI) and p−value (two−sided) from logistic regression stratified for maximum treatment duration of prior erlotinib or gefitinib (>=6 months vs <6 months) and gender.|
1692688|NCT01085136|3112576|Superiority or Other||Hazard Ratio (HR)|1.04||||0.7905|2-Sided|95.0|0.76|1.44|||Stratified log−rank test.|P−value is calculated from two−sided stratified log−rank test.||Hazard ratio was calculated from Cox proportional hazard model with treatment as the only factor, stratified by gender and maximum duration of erlotinib or gefitinib (<6 months vs >=6 months).|
1692689|NCT01085136|3112578|Superiority or Other||Cox Proportional Hazard|0.61||||0.003|2-Sided|95.0|0.44|0.85||P−value is calculated from two−sided stratified log−rank test|stratified log−rank test|||Hazard ratio is calculated from Cox proportional hazard model with treatment as the only factor, stratified by gender and maximum duration of erlotinib or gefitinib (<6 months vs >=6 months).|
1692690|NCT01084655|3112632|Superiority or Other||Ratio of Geometric LS Means|1.068|||||2-Sided|90.0|0.955|1.195||||||ANOVA with dose level as a fixed effect and participant as a random effect.|
1692691|NCT01084655|3112633|Superiority or Other||Ratio of Geometric LS Means|1.066|||||2-Sided|90.0|0.802|1.417||||||ANOVA with dose level as a fixed effect and participant as a random effect.|
1692692|NCT01084655|3112636|Superiority or Other||Ratio of Geometric LS Means|1.074|||||2-Sided|90.0|0.793|1.455||||||ANOVA with dose level as a fixed effect and participant as a random effect.|
1692693|NCT01084655|3112637|Superiority or Other||Ratio of Geometric Least Square(LS)Means|1.204|||||2-Sided|90.0|0.87|1.666||||||ANOVA with dose level as a fixed effect and participant as a random effect.|
1692694|NCT01084239|3112728|Superiority or Other||||||<|0.001|||||||Fisher Exact|Result for index hospitalization|||
1692695|NCT01084174|3112731|Other|||||||0.007|||||||Regression, Linear||||
1692696|NCT01084174|3112732|Other|||||||0.07|||||||Regression, Linear||||
1692697|NCT01084174|3112733|Other|||||||0.4|||||||Regression, Linear||||
1692698|NCT01084174|3112734|Other||||||<|0.001|||||||Regression, Linear||||
1692699|NCT01084174|3112735|Other||||||<|0.001|||||||Regression, Linear||||
1692700|NCT01084174|3112736|Other|||||||0.003|||||||Regression, Linear|Analyzed by linear regression models using generalized estimating equations to account for repeated measures over time with robust standard errors|||
1692701|NCT01084005|3112745|Superiority or Other||Odds Ratio (OR)|0.214||||0.0048|2-Sided|95.0|0.073|0.625|||Regression, Logistic|||Lina 5 mg qd vs Placebo|
1692702|NCT01084005|3112748|Superiority or Other||Odds Ratio (OR)|8.319|||<|0.0001||95.0|3.321|20.837|||Regression, Logistic||||
1692703|NCT01084005|3112749|Superiority or Other||Mean Difference (Final Values)|-21.6|Standard Error of the Mean|4.2|<|0.0001||95.0|-29.8|-13.4|||Mixed Models Analysis||||
1692704|NCT01084005|3112750|Superiority or Other||Mean Difference (Final Values)|-21.5|Standard Error of the Mean|3.4|<|0.0001||95.0|-28.1|-14.8|||Mixed Models Analysis||||
1692705|NCT01084005|3112751|Superiority or Other||Mean Difference (Final Values)|-18.6|Standard Error of the Mean|3.1|<|0.0001||95.0|-24.7|-12.6|||Mixed Models Analysis||||
1692710|NCT01084005|3112756|Superiority or Other||Mean Difference (Final Values)|-0.64|Standard Error of the Mean|0.08|<|0.0001||95.0|-0.81|-0.48|||ANCOVA||||
1692711|NCT01083901|3112759|Superiority or Other|||||||0.37|||||||ANCOVA|Changes in strength were regressed on the baseline measure.|||
1692712|NCT01083901|3112760|Superiority or Other|||||||0.3|||||||ANCOVA|Change in strength was regressed on baseline measures.|||
1692713|NCT01083901|3112761|Superiority or Other|||||||0.23|||||||ANCOVA|The change in fat mass was regressed on the baseline measure.|||
1692714|NCT01083901|3112762|Superiority or Other|||||||0.38|||||||ANCOVA|Changes from baseline to 16 weeks were regressed on the baseline measurement.||The null hypothesis was that the changes in total body fat-free mass in response to resistance exercise training would not be different among the groups. The expected difference in fat-free mass between the Acetaminophen and Placebo groups was 1.8 +/- 1.0% with a 3.6 +/1 1.0% increase in fat-free mass in the Placebo group. The study was designed to achieve 96% power at the 0.05 level with 10 men in the acetaminophen and placebo groups.|
1692715|NCT01083654|3112847|Superiority or Other||Odds Ratio (OR)|0.56||||0.262|2-Sided|95.0|0.2|1.55|||Regression, Logistic||||
1692716|NCT01083485|3112874|Non-Inferiority or Equivalence|Previously provided|Mean Difference (Final Values)|-0.1|||||2-Sided|95.0|-0.5|0.3||||||The sample size was calculated for a significance level of 2.5% (1 sided) with 90% power. A within SD 1.7, and expected treatment difference of 0 and a non-inferiority margin of 1.0 were assumed.|
1692717|NCT01083173|3112920|Superiority or Other||||||<|0.0001|||||||Paired t-test|||CD4 cell counts at 48 weeks as compared to baseline|
1692718|NCT01083173|3112920|Superiority or Other||||||<|0.0001|||||||Paired t-test|||CD4 cell counts at 24 weeks as compared to baseline|
1692719|NCT01082965|3112931|Superiority or Other||LS Mean Difference|0.04|Standard Error of the Mean|0.044||0.4388|2-Sided|95.0|-0.06|0.13||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692720|NCT01082965|3112931|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.033||0.8863|2-Sided|95.0|-0.07|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692721|NCT01082965|3112931|Superiority or Other||LS Mean Difference|0.01|Standard Error of the Mean|0.029||0.6585|2-Sided|95.0|-0.05|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1, Identification Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692722|NCT01082965|3112931|Superiority or Other||LS Mean Difference|0.05|Standard Error of the Mean|0.048||0.3277|2-Sided|95.0|-0.06|0.16||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692723|NCT01082965|3112931|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.057||0.1031|2-Sided|95.0|-0.02|0.22||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692724|NCT01082965|3112931|Superiority or Other||LS Mean Difference|0.04|Standard Error of the Mean|0.059||0.494|2-Sided|95.0|-0.09|0.17||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1, Detection Task: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692725|NCT01082965|3112932|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|1.95||0.7684|2-Sided|95.0|-4.17|5.37||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Total DR: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692726|NCT01082965|3112932|Superiority or Other||LS Mean Difference|-4.39|Standard Error of the Mean|3.479||0.254|2-Sided|95.0|-12.9|4.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Total IR: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692727|NCT01082965|3112933|Superiority or Other||LS Mean Difference|9.86|Standard Error of the Mean|8.921||0.3228|2-Sided|95.0|-13.56|33.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 8: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692728|NCT01082965|3112933|Superiority or Other||LS Mean Difference|9.79|Standard Error of the Mean|9.143||0.3157|2-Sided|95.0|-11.3|30.87||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692729|NCT01082965|3112933|Superiority or Other||LS Mean Difference|5.0|Standard Error of the Mean|12.11||0.688|2-Sided|95.0|-21.82|31.82||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 5 on Day 1: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692730|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.32|Standard Error of the Mean|0.125||0.0402|2-Sided|95.0|-0.62|-0.02||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692731|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.03|Standard Error of the Mean|0.22||0.9046|2-Sided|95.0|-0.5|0.45||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692815|NCT01081834|3113072|Superiority or Other||Least-Squares Mean Difference|-64.0|Standard Error of the Mean|5.616|<|0.001|2-Sided|95.0|-75.02|-52.94|||ANCOVA||||
1692732|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.12|Standard Error of the Mean|0.194||0.552|2-Sided|95.0|-0.56|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Landau: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692733|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.15|Standard Error of the Mean|0.123||0.2959|2-Sided|95.0|-0.42|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692734|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.04|Standard Error of the Mean|0.164||0.8205|2-Sided|95.0|-0.4|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692735|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.07|Standard Error of the Mean|0.14||0.635|2-Sided|95.0|-0.39|0.25||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Hippocampus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692736|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.06|Standard Error of the Mean|0.119||0.619|2-Sided|95.0|-0.2|0.32||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692737|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.11|Standard Error of the Mean|0.067||0.1246|2-Sided|95.0|-0.04|0.27||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692738|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.19|Standard Error of the Mean|0.102||0.0974|2-Sided|95.0|-0.04|0.42||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Basal Ganglia: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692739|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.01|Standard Error of the Mean|0.263||0.9837|2-Sided|95.0|-0.73|0.74||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692740|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.31|Standard Deviation|0.326||0.363|2-Sided|95.0|-0.42|1.04||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692741|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.34|Standard Error of the Mean|0.358||0.4182|2-Sided|95.0|-0.8|1.47||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Thalamus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692742|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.14|Standard Error of the Mean|0.143||0.3524|2-Sided|95.0|-0.45|0.17||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692743|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.13|Standard Error of the Mean|0.188||0.5069|2-Sided|95.0|-0.54|0.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692744|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.162||0.2299|2-Sided|95.0|-0.55|0.15||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Amygdala: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692745|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.01|Standard Error of the Mean|0.179||0.9456|2-Sided|95.0|-0.4|0.43||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692746|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.01|Standard Error of the Mean|0.228||0.9778|2-Sided|95.0|-0.49|0.5||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692747|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.16|Standard Error of the Mean|0.192||0.4226|2-Sided|95.0|-0.59|0.27||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Anterior Cingulate Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692748|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.26|Standard Error of the Mean|0.165||0.1491|2-Sided|95.0|-0.64|0.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692749|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.08|Standard Error of the Mean|0.171||0.6348|2-Sided|95.0|-0.46|0.29||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692750|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.16|Standard Error of the Mean|0.143||0.314|2-Sided|95.0|-0.5|0.18||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Precuneus: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692751|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.151||0.5176|2-Sided|95.0|-0.45|0.24||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692752|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.22|Standard Error of the Mean|0.161||0.1991|2-Sided|95.0|-0.58|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692753|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.11|Standard Error of the Mean|0.124||0.3925|2-Sided|95.0|-0.41|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Insula: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692754|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.32|Standard Error of the Mean|0.163||0.1061|2-Sided|95.0|-0.73|0.1||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692755|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.05|Standard Error of the Mean|0.158||0.7687|2-Sided|95.0|-0.41|0.31||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692756|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.086||0.0659|2-Sided|95.0|-0.41|0.02||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Parietal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692757|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.189||0.6435|2-Sided|95.0|-0.47|0.67||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692758|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.27|Standard Error of the Mean|0.186||0.2136|2-Sided|95.0|-0.77|0.23||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692759|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.01|Standard Error of the Mean|0.145||0.9471|2-Sided|95.0|-0.53|0.51||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Superior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692760|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.07|Standard Error of the Mean|0.14||0.6558|2-Sided|95.0|-0.41|0.28||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692761|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.16||0.9861|2-Sided|95.0|-0.36|0.36||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692762|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.17|Standard Error of the Mean|0.151||0.3053|2-Sided|95.0|-0.2|0.53||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692763|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.13|Standard Error of the Mean|0.132||0.3588|2-Sided|95.0|-0.44|0.18||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692764|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.171||0.1085|2-Sided|95.0|-0.68|0.08||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692765|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.08|Standard Error of the Mean|0.196||0.7029|2-Sided|95.0|-0.56|0.4||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Medial Prefrontal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692766|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.12|Standard Error of the Mean|0.161||0.4946|2-Sided|95.0|-0.26|0.49||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692816|NCT01081834|3113072|Superiority or Other||Least-Squares Mean Difference|-49.1|Standard Error of the Mean|5.629|<|0.001|2-Sided|95.0|-59.12|-36.99|||ANCOVA||||
1692817|NCT01081834|3113073|Superiority or Other||Least-Squares Mean Difference|-43.4|Standard Error of the Mean|3.402|<|0.001|2-Sided|95.0|-50.06|-36.69|||ANCOVA||||
1692767|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.218||0.1928|2-Sided|95.0|-0.18|0.79||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692768|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.07|Standard Error of the Mean|0.203||0.7555|2-Sided|95.0|-0.39|0.52||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Inferior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692769|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.02|Standard Error of the Mean|0.117||0.8922|2-Sided|95.0|-0.28|0.25||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692770|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.01|Standard Error of the Mean|0.109||0.8987|2-Sided|95.0|-0.26|0.29||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692771|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.08|Standard Error of the Mean|0.189||0.6828|2-Sided|95.0|-0.59|0.43||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Medial Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692772|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.03|Standard Error of the Mean|0.134||0.807|2-Sided|95.0|-0.33|0.26||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692773|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.18|Standard Error of the Mean|0.151||0.2416|2-Sided|95.0|-0.51|0.14||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692774|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.19|Standard Error of the Mean|0.123||0.1555|2-Sided|95.0|-0.46|0.09||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Superior Temporal Cortex: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692775|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.03|Standard Error of the Mean|0.059||0.5847|2-Sided|95.0|-0.12|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 8, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692776|NCT01082965|3112934|Superiority or Other||LS Mean Difference|0.03|Standard Error of the Mean|0.063||0.6256|2-Sided|95.0|-0.12|0.19||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 0 on Day 8, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692777|NCT01082965|3112934|Superiority or Other||LS Mean Difference|-0.03|Standard Error of the Mean|0.057||0.6316|2-Sided|95.0|-0.18|0.12||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Change at Hour 4 on Day 1, Whole Brain Gray: MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692778|NCT01082965|3112935|Superiority or Other||LS Mean Difference|-0.19|Standard Error of the Mean|0.153||0.2548|2-Sided|95.0|-0.53|0.16||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692779|NCT01082965|3112936|Superiority or Other||LS Mean Difference|-0.01|Standard Error of the Mean|0.232||0.9638|2-Sided|95.0|-0.51|0.49||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||MMRM was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, ApoE genotype, site as covariates.|
1692780|NCT01082965|3112937|Superiority or Other||Leasts Square (LS) Mean|-0.01|Standard Error of the Mean|0.265||0.9742|2-Sided|95.0|-0.6|0.58||Statistical significance level alpha (2-sided) was 0.05.|Mixed Models Analysis|||Mixed model for repeated measures (MMRM) was used with treatment, time, treatment-by-time interaction as fixed effects and baseline, age, gender, Apolipoprotein E (ApoE) genotype, site as covariates.|
1692781|NCT01082952|3112939|Superiority or Other||||||<|0.05||||||The p value is calculated for the results of ASM proliferation following incubation with eosinophils isolated from patients in each group. p< 0.05 was considered significant.|ANOVA|Proliferation data was evaluated using two-way factorial ANOVA followed by Bonferroni post hoc test.|||
1692782|NCT01082640|3112952|Superiority or Other|||||||0.062|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.|||
1692783|NCT01082640|3112952|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.|||
1692784|NCT01082640|3112952|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Prior use of an ARB, ACEi, or none was a stratification variable.|||
1692785|NCT01082640|3112953|Superiority or Other||LS mean difference|1.19|Standard Error of the Mean|1.698||0.485|2-Sided|95.0|-2.18|4.57||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.|||
1692786|NCT01082640|3112953|Superiority or Other||LS mean difference|2.38|Standard Error of the Mean|1.687||0.162|2-Sided|95.0|-0.97|5.73||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.|||
1694055|NCT01065454|3115344|Superiority or Other (legacy)||LS-MEANS Difference|-24.62|||||2-Sided|95.0|-117.58|68.33|||||||
1692787|NCT01082640|3112954|Superiority or Other||LS mean difference|0.04|Standard Error of the Mean|0.133||0.789|2-Sided|95.0|-0.23|0.3||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||All statistical tests were two sided and conducted at the 0.05 significance level.|
1692788|NCT01082640|3112954|Superiority or Other||LS mean difference|-0.1|Standard Error of the Mean|0.134||0.459|2-Sided|95.0|-0.37|0.17||No adjustment for multiplicity was made.|ANCOVA|The model included treatment as a factor, and the baseline value and prior use of an ARB or an ACEi or none as covariates.||All statistical tests were two sided and conducted at the 0.05 significance level.|
1692789|NCT01082367|3112999|Superiority or Other||Odds Ratio (OR)|21.55|||<|0.001|2-Sided|95.0|4.67|99.52|||Regression, Logistic||||
1692790|NCT01082211|3113006|Other|||||||0.087|||||||Spearman rank-order correlation test||||
1692791|NCT01082211|3113006|Other|||||||0.044|||||||Spearman rank-order correlation test||||
1692792|NCT01082211|3113006|Other|||||||0.054|||||||Spearman rank-order correlation test||||
1692793|NCT01082211|3113008|Other||Effect size|0.28|||||2-Sided||||||||Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7|Breast-specific pain|
1692794|NCT01082211|3113008|Other||Effect size|0.32|||||2-Sided||||||||Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7|Cosmetic|
1692795|NCT01082211|3113008|Other||Effect size|0.04|||||2-Sided||||||||Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7|Functional status|
1692796|NCT01082211|3113009|Other||Effect size|0.34|||||2-Sided||||||||Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7|Breast-specific pain|
1692797|NCT01082211|3113009|Other||Effect size|0.14|||||2-Sided||||||||Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7|Cosmetic|
1692798|NCT01082211|3113009|Other||Effect size|0.1|||||2-Sided||||||||Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7|Functional status|
1692799|NCT01082211|3113017|Superiority or Other|||||||0.0002|||||||Chi-squared|||Assuming a 3-year rate of 25% using a chi-squared test, a sample size of 55 patients will ensure at least 90% probability of detecting a reduction in the 3-year ipsilateral in-breast recurrence rate from 25% to 9%, with a significance level of 0.05 (1-sided). In-breast recurrence will be estimated using the cumulative incidence method.|
1692800|NCT01082159|3113020|Superiority or Other||Change from Baseline|12.17|Standard Deviation|19.14|<|0.0001|2-Sided|95.0|6.64|17.71|||t-test, 2 sided||||
1692801|NCT01082159|3113021|Superiority or Other||change from baseline|3.59|Standard Deviation|2.87|<|0.0001|2-Sided|95.0|2.76|4.42|||t-test, 2 sided||||
1692802|NCT01082081|3113036|Superiority or Other||Adjusted Mean Difference|2.48||||0.1307|2-Sided|95.0|-0.74|5.69|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID^6h between Paracetamol 500 mg caplet and placebo caplet.|
1692803|NCT01082081|3113036|Superiority or Other||Adjusted Mean Difference|7.25|||<|0.0001|2-Sided|95.0|4.04|10.45|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID^6h between Paracetamol 1000 mg caplet and placebo caplet.|
1692804|NCT01082081|3113036|Superiority or Other||Adjusted Mean Difference|4.77|||<|0.0004|2-Sided|95.0|2.15|7.39|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID^6h between Paracetamol 1000 mg caplet and Paracetamol 500 mg caplet.|
1692805|NCT01081951|3113038|Superiority or Other (legacy)||Hazard Ratio (HR)|1.17||||0.4379|2-Sided|95.0|0.79|1.73||Two sided|Log Rank|Stratified by number of prior platinum treatment lines (1 or >1) and time to progression following previous platinum therapy (>6 to ≤12 vs >12 months)|A hazard ratio < 1 favours favours olaparib.|The null hypothesis for all efficacy analyses in this study is that there is no difference in treatment effects between olaparib in combination with carboplatin/paclitaxel compared with carboplatin/paclitaxel alone.|
1692806|NCT01081951|3113039|Superiority or Other (legacy)||Hazard Ratio (HR)|0.51||||0.0012|2-Sided|95.0|0.34|0.77||The use of a one-sided 10% significance level test will be used to assess the statistical significance of the analyses of PFS.|Log Rank|Stratified by number of prior platinum treatment lines (1 or >1) and time to progression following previous platinum therapy (>6 to ≤12 vs >12 months)|A hazard ratio of < 1 favours olaparib.|The null hypothesis for all efficacy analyses in this study is that there is no difference in treatment effects between olaparib in combination with carboplatin/paclitaxel compared with carboplatin/paclitaxel alone.|
1692807|NCT01081834|3113068|Superiority or Other||Least-Squares Mean Difference|6.0|Standard Error of the Mean|1.9||0.002|2-Sided|95.0|2.2|9.9|||ANCOVA||||
1692808|NCT01081834|3113068|Superiority or Other||Least-Squares Mean Difference|6.7|Standard Error of the Mean|1.9|<|0.001|2-Sided|95.0|2.9|10.6|||ANCOVA||||
1692809|NCT01081834|3113069|Superiority or Other||Least-Squares Mean Difference|-10.2|Standard Error of the Mean|4.8||0.034|2-Sided|95.0|-19.6|-0.8|||ANCOVA||||
1692810|NCT01081834|3113069|Superiority or Other||Least-Squares Mean Difference|-5.3|Standard Error of the Mean|4.8||0.267|2-Sided|95.0|-14.8|4.1|||ANCOVA||||
1692811|NCT01081834|3113070|Superiority or Other||Least-Squares Mean Difference|-5.42|Standard Error of the Mean|1.088|<|0.001|2-Sided|95.0|-7.556|-3.28|||ANCOVA||||
1692812|NCT01081834|3113070|Superiority or Other||Least-Squares Mean Difference|-3.71|Standard Error of the Mean|1.093|<|0.001|2-Sided|95.0|-5.86|-1.568|||ANCOVA||||
1692813|NCT01081834|3113071|Superiority or Other||Least-Squares Mean Difference|-3.3|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-4.0|-2.6|||ANCOVA||||
1692814|NCT01081834|3113071|Superiority or Other||Least-Squares Mean Difference|-2.2|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-2.9|-1.6|||ANCOVA||||
1692818|NCT01081834|3113073|Superiority or Other||Least-Squares Mean Difference|-35.5|Standard Error of the Mean|3.42|<|0.001|2-Sided|95.0|-42.22|-28.78|||ANCOVA||||
1692819|NCT01081834|3113074|Superiority or Other||Odds Ratio (OR)|14.61|||<|0.001|2-Sided|95.0|8.14|26.25|||Regression, Logistic||||
1692820|NCT01081834|3113074|Superiority or Other||Odds Ratio (OR)|5.34|||<|0.001|2-Sided|95.0|3.1|9.23|||Regression, Logistic||||
1692821|NCT01081834|3113076|Superiority or Other||Least-Squares Mean Difference|-1.16|Standard Error of the Mean|0.091|<|0.001|2-Sided|95.0|-1.342|-0.985|||ANCOVA||||
1692822|NCT01081834|3113076|Superiority or Other||Least-Squares Mean Difference|-0.91|Standard Error of the Mean|0.091|<|0.001|2-Sided|95.0|-1.088|-0.729|||ANCOVA||||
1692823|NCT01081795|3113078|Superiority or Other||Percentage difference|2.0||||0.7235|2-Sided|95.0|-6.6|10.6||Month 6|Fisher Exact||||
1692824|NCT01081795|3113078|Superiority or Other||Percentage difference|5.1||||0.3083|2-Sided|95.0|-3.8|14.0||Month 6|Fisher Exact||||
1692825|NCT01081795|3113079|Superiority or Other||LS mean difference|-0.4||||0.2165|2-Sided|95.0|-1.0|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692826|NCT01081795|3113079|Superiority or Other||LS mean difference|-0.4||||0.1743|2-Sided|95.0|-1.0|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692827|NCT01081795|3113081|Superiority or Other||LS mean difference|-0.6||||0.1507|2-Sided|95.0|-1.4|0.2||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692828|NCT01081795|3113081|Superiority or Other||LS mean difference|-0.5||||0.1866|2-Sided|95.0|-1.3|0.3||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692829|NCT01081795|3113082|Superiority or Other||LS mean difference|-0.2||||0.3971|2-Sided|95.0|-0.6|0.2||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692830|NCT01081795|3113082|Superiority or Other||LS mean difference|-0.3||||0.1145|2-Sided|95.0|-0.7|0.1||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692831|NCT01081795|3113083|Superiority or Other||LS mean difference|-0.3||||0.3031|2-Sided|95.0|-0.8|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692832|NCT01081795|3113083|Superiority or Other||LS mean difference|0.0||||0.8762|2-Sided|95.0|-0.6|0.5||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692833|NCT01081795|3113084|Superiority or Other||LS mean difference|-0.3||||0.3148|2-Sided|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692834|NCT01081795|3113084|Superiority or Other||LS mean difference|-0.4||||0.2464|2-Sided|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692835|NCT01081795|3113085|Superiority or Other||LS mean difference|-0.4||||0.2624|2-Sided|95.0|-1.0|0.3||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692836|NCT01081795|3113085|Superiority or Other||LS mean difference|-0.5||||0.1547|2-Sided|95.0|-1.1|0.2||Month 6: ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692837|NCT01081795|3113086|Superiority or Other||LS mean difference|-0.2||||0.4479|2-Sided|95.0|-0.8|0.4||ANCOVA method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692838|NCT01081795|3113086|Superiority or Other||Least Square (LS) mean difference|-0.4||||0.1646|2-Sided|95.0|-1.0|0.2||Analysis of covariance (ANCOVA) method using the treatment group as the factor and using the value obtained during the baseline measurement period as the covariate was used.|ANCOVA||||
1692839|NCT01081769|3113087|Superiority or Other|||||||0.0323|||||||Fisher Exact||||
1692840|NCT01081769|3113101|Superiority or Other|||||||0.0191|||||||Log Rank||||
1692841|NCT01081678|3113107|Other|||||||0.1983|||||||F-test|The p-value is based on F-test of multi-linear contrasts at Week 6 through Week 20.||The primary analysis was based on a test for linear trend in dose response at weeks 6, 12, 16, and 20. To account for multiple comparisons over time points, the primary analysis used a size α = 0.05 F-test with 4 degrees of freedom for the contrasts at Weeks 6, 12, 16, and 20.|
1692842|NCT01081626|3113119|Superiority or Other||Risk Ratio (RR)|1.015||||0.9351|2-Sided|95.0|0.7175|1.435|||Chi-squared||||
1692843|NCT01081626|3113120|Superiority or Other|||||||0.5331|||||||Chi-squared||||
1692844|NCT01081626|3113124|Superiority or Other||Risk Ratio (RR)|1.088||||0.7924|2-Sided|95.0|0.7642|1.549|||Chi-squared||||
1692845|NCT01081626|3113125|Superiority or Other||Mean Difference (Final Values)|0.0135||||0.956|2-Sided|95.0|-0.1325|0.1637|||Chi-squared, Corrected||||
1692846|NCT01081301|3113126|Superiority or Other||||||<|0.05||||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of SF-12v2 Physical health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.|
1692912|NCT01079962|3113313|Superiority or Other|||||||0.1896|||||||t-test, 2 sided|||Change in HDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.|
1694056|NCT01065454|3115345|Superiority or Other (legacy)||LS-MEANS Difference|-7.5|||||2-Sided|95.0|-15.29|0.28|||||||
1692847|NCT01081301|3113127|Superiority or Other||||||>|0.05||||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of Non Death Revised Grief Experience Inventory scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.|
1692848|NCT01081301|3113128|Superiority or Other||||||<|0.05||||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures||Generalized estimating equations were used to determine change in patterns of General Self Efficacy Scale scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.|
1692849|NCT01081301|3113129|Superiority or Other||||||<|0.05||||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of SF-12v2 Mental health scores over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.|
1692850|NCT01081301|3113130|Superiority or Other||||||<|0.05||||||The p-value were not adjusted for multiple comparisons and a p-value of 0.05 was used for statistical significance.|ANOVA|Modified version of ANOVA as it overcomes the shortcoming of the ANOVA model by taking into account unbalanced data and repeated measures.||Generalized estimating equations were used to determine change in patterns of the Herth Hope Index over time (Day 7, 14 and 3, 6, and 12 months) compared to baseline. The advantage of utilizing general estimating equations was that it effectively increases the sample size (increasing power) and estimated more robust standard errors by taking into account the repeated measures and adjusting for covariates.|
1692851|NCT01081145|3113144|Superiority or Other||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|t-test, 2 sided||||
1692852|NCT01081145|3113148|Superiority or Other||||||<|0.001||||||Nominal p-value uncorrected for multiplicity.|t-test, 2 sided||||
1692853|NCT01081145|3113151|Superiority or Other||Difference in Least Squares Mean|-0.06||||0.118|2-Sided|95.0|-0.14|0.02||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1692854|NCT01081145|3113152|Superiority or Other||Difference in percent of subjects|17.5||||0.001|2-Sided|95.0|6.6|28.5||Nominal p-value uncorrected for multiplicity.|Cochran-Mantel-Haenszel||||
1692855|NCT01081145|3113153|Superiority or Other||Difference in Least Squares Mean|-6.24|||<|0.001|2-Sided|95.0|-9.01|-3.48||Nominal p-value uncorrected for multiplicity.|ANCOVA||||
1692856|NCT01081145|3113154|Superiority or Other|||||||0.003|||||||Log Rank||||
1692857|NCT01081145|3113155|Superiority or Other||Difference in treatment failures|-15.6||||0.006|2-Sided|95.0|-26.6|-4.5|||Cochran-Mantel-Haenszel||||
1692858|NCT01081132|3113159|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.465|2-Sided|95.0|-1.8|0.8|||Mixed Models Repeated Measures Analysis||||
1692859|NCT01081132|3113160|Superiority or Other||Mean Difference (Final Values)|-2.7||||0.072|2-Sided|95.0|-5.6|0.2|||Mixed Models Repeated Measures Analysis|||Metacognition Index|
1692860|NCT01081132|3113160|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.579|2-Sided|95.0|-4.0|2.3|||Mixed Models Repeated Measures Analysis|||Behavioral Regulation Index|
1692861|NCT01081132|3113160|Superiority or Other||Mean Difference (Final Values)|-2.3||||0.134|2-Sided|95.0|-5.3|0.7|||Mixed Models Repeated Measures Analysis|||Global Executive Composite|
1692862|NCT01081132|3113161|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1692863|NCT01081132|3113162|Superiority or Other||Mean Difference (Final Values)|-0.208||||0.082|2-Sided|95.0|-0.443|0.026|||Mixed Models Repeated Measures Analysis||||
1692864|NCT01081132|3113163|Superiority or Other||Mean Difference (Final Values)|-0.047||||0.41|2-Sided|95.0|-0.159|0.065|||Mixed Models Repeated Measures Analysis||||
1692865|NCT01081132|3113164|Superiority or Other||Mean Difference (Final Values)|0.102||||0.228|2-Sided|95.0|-0.064|0.268|||Mixed Models Repeated Measures Analysis||||
1692866|NCT01081132|3113165|Superiority or Other||Mean Difference (Final Values)|-0.029||||0.606|2-Sided|95.0|-0.139|0.081|||Mixed Models Repeated Measures Analysis||||
1692867|NCT01081132|3113166|Superiority or Other||Mean Difference (Final Values)|0.004||||0.912|2-Sided|95.0|-0.061|0.068|||Mixed Models Repeated Measures Analysis||||
1692868|NCT01081132|3113167|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.253|2-Sided|95.0|-0.136|-0.036|||Mixed Models Repeated Measures Analysis||||
1692869|NCT01081132|3113168|Superiority or Other||Mean Difference (Final Values)|-0.083||||0.176|2-Sided|95.0|-0.203|0.037|||Mixed Models Repeated Measures Analysis||||
1692870|NCT01081132|3113169|Superiority or Other||Mean Difference (Final Values)|-0.057||||0.408|2-Sided|95.0|-0.192|0.078|||Mixed Models Repeated Measures Analysis||||
1692871|NCT01081132|3113170|Superiority or Other||Mean Difference (Final Values)|-0.115||||0.104|2-Sided|95.0|-0.254|0.024|||Mixed Models Repeated Measures Analysis||||
1692872|NCT01081132|3113171|Superiority or Other|||||||0.01|||||||Cochran-Mantel-Haenszel||||
1692873|NCT01081132|3113172|Superiority or Other||Mean Difference (Final Values)|-6.026|||<|0.001|2-Sided|95.0|-8.865|-3.187|||Mixed Models Repeated Measures Analysis||||
1692874|NCT01080391|3113232|Superiority||Odds Ratio (OR)|1.897||||0.0044|2-Sided|95.0|1.17|3.08|||Cochran-Mantel Haenszel chi-square test|Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.|The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.||
1694057|NCT01065454|3115345|Superiority or Other (legacy)||LS-MEANS Difference|-6.81|||||2-Sided|95.0|-13.96|0.35|||||||
1692875|NCT01080391|3113233|Superiority||Odds Ratio (OR)|3.472|||<|0.0001|2-Sided|95.0|2.411|5.001|||Cochran-Mantel Haenszel chi-square test|Cochran-Mantel Haenszel chi-square test with β2 macroglobulin level, prior bortezomib, and prior lenalidomide as stratification factors.|The odds ratio and 95% CI were estimated using the Mantel-Haenszel method.||
1692876|NCT01080391|3113234|Superiority|The stopping boundary for this analysis was 0.0231 based on 1-sided significance level (O’Brien-Fleming with Lan-DeMets spending function).|Hazard Ratio (HR)|0.794||||0.0045|2-Sided|95.0|0.667|0.945|||Log Rank|Analysis was stratified by β2 microglobulin levels (< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes).||The final analysis of OS was to be performed after 510 deaths occur. A total of 510 deaths would provide 85% power to detect, with a 1-sided significance level of 0.025, a hazard ratio of 0.765 corresponding to a 23.5% reduction in risk for death for CRd versus Rd (39.2 vs. 30.0 months, respectively).|
1692877|NCT01080391|3113235|Superiority or Other||Hazard Ratio (HR)|0.69|||<|0.0001|2-Sided|95.0|0.57|0.834||Analysis was stratified by β2 microglobulin levels (< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes)|Log Rank|The stopping boundary for this analysis was 0.0127 based on 1-sided significance level (O’Brien-Fleming with Lan-DeMets spending function).|||
1692878|NCT01080300|3113238|Superiority or Other (legacy)||Mean Difference (Net)|-0.05|Standard Error of the Mean|0.091||0.5607|2-Sided|95.0|-0.23|0.13||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 24|
1692879|NCT01080300|3113238|Superiority or Other (legacy)||Mean Difference (Net)|-0.14|Standard Error of the Mean|0.084||0.0872|2-Sided|95.0|-0.31|0.02||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 12|
1692880|NCT01080300|3113238|Superiority or Other (legacy)||Mean Difference (Net)|-0.21|Standard Error of the Mean|0.084||0.0137|2-Sided|95.0|-0.37|-0.04||The p-value (vs. Placebo) for the test of difference of the LS mean change from baseline between Gabapentin ER 1800mg and placebo group is based on the F-test of Type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||MENQOL score at Week 4|
1692881|NCT01080300|3113239|Superiority or Other (legacy)||Mean Difference (Net)|-1.76|Standard Error of the Mean|0.548||0.0014|2-Sided|95.0|-2.84|-0.69|||ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 24: LOCF daily insomnia severity index (ISI) rating.|
1692882|NCT01080300|3113239|Superiority or Other (legacy)||Mean Difference (Net)|-1.85|Standard Error of the Mean|0.543||0.0007|2-Sided|95.0|-2.92|-0.78||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 12: LOCF daily insomnia severity index (ISI) rating.|
1692883|NCT01080300|3113239|Superiority or Other (legacy)||Mean Difference (Net)|-2.62|Standard Error of the Mean|0.537|<|0.0001|2-Sided|95.0|-3.67|-1.56||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 4: LOCF daily insomnia severity index (ISI) rating.|
1692884|NCT01080300|3113240|Superiority or Other (legacy)||Mean Difference (Net)|-0.95|Standard Error of the Mean|0.237|<|0.0001|2-Sided|95.0|-1.42|-0.49||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 24: LOCF daily sleep interference rating.|
1692885|NCT01080300|3113240|Superiority or Other (legacy)||Mean Difference (Net)|-0.92|Standard Error of the Mean|0.226|<|0.0001|2-Sided|95.0|-1.36|-0.47||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 12: LOCF daily sleep interference rating.|
1692886|NCT01080300|3113240|Superiority or Other (legacy)||Mean Difference (Net)|-1.36|Standard Error of the Mean|0.196|<|0.0001|2-Sided|95.0|-1.75|-0.97||The P value (versus placebo) for the pairwise test of difference of the LS mean change from Baseline between the G-ER 1800-mg and placebo-treatment groups was based on the F test of type III analysis.|ANCOVA|No multiplicity adjustments were made for secondary efficacy outcomes||Change from Baseline to Week 4: LOCF daily sleep interference rating.|
1692887|NCT01080300|3113241|Superiority or Other (legacy)||Risk Difference (RD)|4.4||||0.1662|2-Sided|95.0|-1.8|10.7|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24|
1692888|NCT01080300|3113241|Superiority or Other (legacy)||Risk Difference (RD)|3.8||||0.1825|2-Sided|95.0|-1.8|9.4|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 12|
1692889|NCT01080300|3113242|Superiority or Other (legacy)||Risk Difference (RD)|7.3||||0.072|2-Sided|95.0|-0.7|15.3|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24|
1692890|NCT01080300|3113242|Superiority or Other (legacy)||Risk Difference (RD)|7.5||||0.0609|2-Sided|95.0|-0.3|15.2|||two-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 12|
1692891|NCT01080300|3113243|Superiority or Other (legacy)||Risk Difference (RD)|11.0||||0.007|2-Sided|95.0|3.0|19.0|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|Week 24|
1692913|NCT01079962|3113313|Superiority or Other|||||||0.1919|||||||t-test, 2 sided|||Change in LDL-cholesterol at Week 12: p-value was calculated by 2 sided t-test.|
1692914|NCT01079962|3113313|Superiority or Other|||||||0.396|||||||t-test, 2 sided|||Change in Total cholesterol at Week 12: p-value was calculated by 2 sided t-test.|
1692892|NCT01080300|3113243|Superiority or Other (legacy)||Risk Difference (RD)|16.4|||<|0.0001|2-Sided|95.0|8.4|24.3|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in CGIC at Week 12.~Null Hypotheses: no treatment differences, relative to placebo in the proportion of patients who were categorized as very much or much improved in the CGIC score at week 12."|
1692893|NCT01080300|3113244|Superiority or Other (legacy)||Risk Difference (RD)|13.4||||0.0009|2-Sided|95.0|5.5|21.3|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in PGIC at Week 24."|
1692894|NCT01080300|3113244|Superiority or Other (legacy)||Risk Difference (RD)|13.6||||0.0008|2-Sided|95.0|5.7|21.6|||2-sample Z test|No multiplicity adjustments were made for secondary efficacy outcomes|Risk difference defined as treatment difference in proportion of responders.|"Proportion of patients who were categorized as very much or much improved in PGIC at Week 12.~Null Hypotheses: no treatment differences, relative to placebo in the proportion of patients who were categorized as very much or much improved in the PGIC score at week 12.."|
1692895|NCT01080300|3113245|Superiority or Other (legacy)||Mean Difference (Net)|-0.22|Standard Error of the Mean|0.11||0.0004|2-Sided|95.0|-0.44|0.0|||Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 24:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in observed average daily severity score of moderate to severe hot flashes at Week 24."|
1692896|NCT01080300|3113246|Superiority or Other (legacy)||Mean Difference (Net)|-1.08|Standard Error of the Mean|0.453||0.151|2-Sided|95.0|-1.98|-0.19|||Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 24:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in observed average daily number of moderate to severe hot flashes at Week 24."|
1692897|NCT01080300|3113247|Superiority or Other (legacy)||Mean Difference (Net)|-0.19|Standard Error of the Mean|0.072||0.0004|2-Sided|95.0|-0.33|-0.04||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 12:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate to severe hot flashes at Week 12."|
1692898|NCT01080300|3113247|Superiority or Other (legacy)||Mean Difference (Net)|-0.21|Standard Error of the Mean|0.052|<|0.0001|2-Sided|95.0|-0.31|-0.1||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Severity Score at Week 4:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate to severe hot flashes at Week 4."|
1692899|NCT01080300|3113248|Superiority or Other (legacy)||Mean Difference (Net)|-1.14|Standard Error of the Mean|0.335||0.1|2-Sided|95.0|-1.8|-0.48||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Elteren|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 12:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate to severe hot flashes at Week 12."|
1692900|NCT01080300|3113248|Superiority or Other (legacy)||Mean Difference (Net)|-1.7|Standard Error of the Mean|0.311||0.0003|2-Sided|95.0|-2.31|-1.09||P-value for the test of difference of the least square mean change from baseline between Gabapentin ER 1800 mg and placebo group is based on the F-test of Type III analysis.|Based on Van Eltereen|Multiplicity addressed by requiring significance for all primary endpoints.|Based on ANCOVA|"Baseline LOCF Average Daily Frequency at Week 4:~Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate to severe hot flashes at Week 4."|
1692901|NCT01080261|3113260|Non-Inferiority or Equivalence|Study had 91% statistical power to demonstrate that the 9-month rate for MACE (accounting for an expected 9-month attrition rate of 10%) is less than the performance goal, assuming a 9-month MACE rate of 8.2%.|Percent of patients experiencing a MACE|0.0|||<|0.0001|1-Sided|95.0||4.9|||One-group exact binomial test|||A one-group exact binomial test was used to test the hypothesis that the percentage of patients experiencing a MACE event (primary endpoint) in the PROMUS Element cohort is less than the predefined performance goal of 24.1% (based on historical outcomes with plain balloon angioplasty [20.2%] plus an adjustment of 3.9% for small vessels).|
1692902|NCT01080118|3113306|Non-Inferiority or Equivalence|Equivalence||||||0.001|||||||t-test, 2 sided||||
1692903|NCT01080118|3113306|Superiority or Other||Odds Ratio, log|0.05||||0.001|2-Sided|99.0|0.05|0.05|||t-test, 2 sided||||
1692904|NCT01079962|3113309|Superiority or Other||Mean Difference (Final Values)|0.442||||0.7561||95.0|-2.36|3.24||No adjustment of p-value was done and priori threshold was 0.05.|t-test, 2 sided||||
1692905|NCT01079962|3113311|Superiority or Other|||||||0.1207|||||||t-test, 2 sided|||Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.|
1692906|NCT01079962|3113311|Superiority or Other|||||||0.51|||||||t-test, 2 sided|||Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.|
1692907|NCT01079962|3113311|Superiority or Other|||||||0.042|||||||t-test, 2 sided|||Change in DBP at Week 12: p-value was calculated by 2 sided t-test.|
1692908|NCT01079962|3113311|Superiority or Other|||||||0.2876|||||||t-test, 2 sided|||Change in DBP at Week 4: p-value was calculated by 2 sided t-test.|
1692909|NCT01079962|3113311|Superiority or Other|||||||0.4731|||||||t-test, 2 sided|||Change in SBP at Week 12: p-value was calculated by 2 sided t-test.|
1692910|NCT01079962|3113311|Superiority or Other|||||||0.9692|||||||t-test, 2 sided|||Change in SBP at Week 4: p-value was calculated by 2 sided t-test.|
1692911|NCT01079962|3113312|Superiority or Other|||||||0.9244|||||||t-test, 2 sided||||
1692915|NCT01079962|3113314|Superiority or Other|||||||0.4447|||||||t-test, 2 sided||||
1692916|NCT01079962|3113315|Superiority or Other|||||||0.523|||||||t-test, 2 sided|||Change in heart rate at Week 12: p-value was calculated by 2 sided t-test.|
1692917|NCT01079962|3113315|Superiority or Other|||||||0.9943|||||||t-test, 2 sided|||Change in heart rate at Week 4: p-value was calculated by 2 sided t-test.|
1692918|NCT01079962|3113316|Superiority or Other|||||||0.5007|||||||t-test, 2 sided|||Change in cfPWV at Week 12: p-value was calculated by 2 sided t-test.|
1692919|NCT01079962|3113316|Superiority or Other|||||||0.2511|||||||t-test, 2 sided|||Change in cfPWV at Week 4: p-value was calculated by 2 sided t-test.|
1692920|NCT01079962|3113317|Superiority or Other|||||||0.6584|||||||t-test, 2 sided|||Change in AIx at Week 12: p-value was calculated by 2 sided t-test.|
1692921|NCT01079962|3113317|Superiority or Other|||||||0.2987|||||||t-test, 2 sided|||Change in AIx at Week 4: p-value was calculated by 2 sided t-test.|
1692922|NCT01079962|3113318|Superiority or Other|||||||0.1586|||||||t-test, 2 sided|||Change in mean BP at Week 12: p-value was calculated by 2 sided t-test.|
1692923|NCT01079962|3113318|Superiority or Other|||||||0.4188|||||||t-test, 2 sided|||Change in mean BP at Week 4: p-value was calculated by 2 sided t-test.|
1692924|NCT01079962|3113318|Superiority or Other|||||||0.1481|||||||t-test, 2 sided|||Change in DBP at Week 12: p-value was calculated by 2 sided t-test.|
1692925|NCT01079962|3113318|Superiority or Other|||||||0.2443|||||||t-test, 2 sided|||Change in DBP at Week 4: p-value was calculated by 2 sided t-test.|
1692926|NCT01079962|3113318|Superiority or Other|||||||0.2223|||||||t-test, 2 sided|||Change in SBP at Week 12: p-value was calculated by 2 sided t-test.|
1692927|NCT01079962|3113318|Superiority or Other|||||||0.8589|||||||t-test, 2 sided|||Change in SBP at Week 4: p-value was calculated by 2 sided t-test.|
1692928|NCT01079962|3113319|Superiority or Other||Mean Difference (Final Values)|0.701||||0.5943|2-Sided|95.0|-1.89|3.29||No adjustment of p-value was done and priori threshold was 0.05.|t-test, 2 sided|||Change in APP at Week 12: p-value was calculated by 2 sided t-test.|
1692929|NCT01079949|3113320|Superiority or Other|||||||0.8812|||||||ANOVA||||
1692930|NCT01079949|3113321|Superiority or Other|||||||0.0166|||||||Wilcoxon two sample test||||
1692931|NCT01079949|3113323|Superiority or Other|||||||0.0634|||||||Wilcoxon two sample test||||
1692932|NCT01079949|3113324|Superiority or Other|||||||0.6799|||||||ANOVA||||
1692933|NCT01079949|3113325|Superiority or Other|||||||0.0648|||||||Wilcoxon two sample test||||
1692934|NCT01079949|3113328|Superiority or Other|||||||0.408|||||||Wilcoxon two sample test||||
1692935|NCT01079949|3113332|Superiority or Other|||||||0.0642|||||||Wilcoxon two sample test||||
1692936|NCT01079949|3113333|Superiority or Other|||||||0.1734|||||||Wilcoxon two sample test||||
1692937|NCT01079949|3113338|Superiority or Other|||||||0.5739|||||||Wilcoxon two sample test||||
1692938|NCT01079806|3113358|Superiority||Difference estimate|12.1||||0.11|2-Sided|95.0|-1.5|25.7|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.||
1692939|NCT01079806|3113359|Superiority||Difference estimate|38.2|||<|0.0001|2-Sided|95.0|25.9|50.5|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.||
1692940|NCT01079806|3113360|Superiority||Difference estimate|45.2|||<|0.0001||95.0|29.2|61.2|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.||
1692941|NCT01079806|3113361|Superiority||Difference estimate|41.8|||<|0.0001|2-Sided|95.0|29.4|54.2|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.||
1692942|NCT01079806|3113362|Superiority||Difference estimate|20.2||||0.0049|2-Sided|95.0|9.1|31.4|||Normal approximation||Difference estimate is stratified by age randomization strata, using Cochran-Mantel-Haenszel weighting.||
1692943|NCT01078805|3113439|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1692944|NCT01078805|3113440|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1692945|NCT01078805|3113441|Superiority or Other|||||||0.0631||||||Comparison is between 0 to 6 months fracture incidence rate versus 18 to 24 months fracture incidence rate.|One-sample binomial proportion test||||
1692946|NCT01078805|3113441|Superiority or Other|||||||0.0412||||||Comparison is between 0 to 6 months fracture incidence rate versus 12 to 18 months fracture incidence rate.|One-sample binomial proportion test||||
1692947|NCT01078805|3113441|Superiority or Other|||||||0.0689||||||Comparison is between 0 to 6 months fracture incidence rate versus 6 to 12 months fracture incidence rate.|One-sample binomial proportion test||||
1692948|NCT01078805|3113442|Superiority or Other|||||||0.0143||||||Comparison is between 0 to 6 months fracture incidence rate versus 18 to 24 months fracture incidence rate.|One-sample binomial proportion test||||
1692949|NCT01078805|3113442|Superiority or Other|||||||0.0019||||||Comparison is between 0 to 6 months fracture incidence rate versus 12 to 18 months fracture incidence rate.|One-sample binomial proportion test||||
1692950|NCT01078805|3113442|Superiority or Other|||||||0.0177||||||Comparison is between 0 to 6 months fracture incidence rate versus 6 to 12 months fracture incidence rate.|One-sample binomial proportion test||||
1692951|NCT01078753|3113443|Superiority or Other||Least Squares Mean Difference|0.183||||0.752|2-Sided|95.0|-0.968|1.335|||ANCOVA|Factors in the analysis included Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.|||
1692952|NCT01078753|3113444|Superiority or Other||Least Squares mean Difference|1.629||||0.018|2-Sided|95.0|0.287|2.972|||ANCOVA|Factors in the analysis were Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.|||
1692953|NCT01078753|3113445|Superiority or Other||Least Squares Mean Difference|1.813||||0.009|2-Sided|95.0|0.462|3.163||Desmopressin was considered to be superior to Placebo if the p-value for the comparison was < 0.05 and the reduction from Baseline in number of wet nights was larger in the FE992026 group than in the Placebo group.|ANCOVA|Factors in the analysis were Gender (male, female), age (6≤x≤9, 10≤x≤15), number of wet nights at Baseline (10≤x≤13, x=14), and treatment group.|||
1693008|NCT01078168|3113605|Superiority or Other||Mean Difference (Final Values)|0.3769||||0.0347|2-Sided|95.0|0.03025|0.7235||threshold: p<0.05|t-test, 2 sided||||
1692954|NCT01078675|3113458|Superiority or Other||Mean Difference (Final Values)|-42.88|Standard Deviation|18.222|<|0.001|2-Sided|-42.88|-45.44|-40.32||P-value<0.001 at Month 24. No adjustment for multiple comparisons is made for individual age group.|ANCOVA|P-value is two-sided and based on ANCOVA using age group as the fixed factor, and study centre and the baseline value as covariates.|||
1692955|NCT01078623|3113468|Superiority or Other||Least squares mean difference|0.234|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.186|0.281|||Mixed Models Analysis|Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate|||
1692956|NCT01078623|3113468|Superiority or Other||Least squares mean difference|0.221|Standard Error of the Mean|0.024|<|0.0001|2-Sided|95.0|0.174|0.268|||Mixed Models Analysis|Treatment and period as fixed effects, subject as random effect, and baseline values at each period as a covariate|||
1692957|NCT01078389|3113548|Superiority or Other|||||||0.122|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Total Score as a covariate.||Change from Baseline at Month 24|
1692958|NCT01078389|3113549|Superiority or Other|||||||0.307|||||||Ranked ANCOVA|Baseline RAMRIS Edema(Distal+Proximal) Score as a covariate.||Edema(Distal+Proximal): Change from Baseline at Month 24|
1692959|NCT01078389|3113549|Superiority or Other|||||||0.634|||||||Ranked ANCOVA|Baseline RAMRIS Erosion(Distal+Proximal) Score as a covariate.||Erosion(Distal+Proximal): Change from Baseline at Month 24|
1692960|NCT01078389|3113549|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|Baseline RAMRIS Synovitis Score as a covariate.||Synovitis: Change from Baseline at Month 24|
1692961|NCT01078389|3113550|Superiority or Other|||||||0.389|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Erosion Score from full hands and feet as a covariate.||Change from Baseline at Month 24|
1692962|NCT01078389|3113551|Superiority or Other|||||||0.548|||||||Ranked ANCOVA|Baseline modified Sharp/van der Heijde Total Score from full hands and feet as a covariate.||Change from Baseline at Month 24|
1692963|NCT01078389|3113552|Superiority or Other|||||||0.472|||||||Ranked Analysis of Covariance (ANCOVA)|Baseline modified Sharp/van der Heijde Erosion Score as a covariate.||Change from Baseline at Month 24|
1692964|NCT01078298|3113583|Superiority or Other||Odds Ratio (OR)|1.97||||0.0027|2-Sided|95.0|1.26|3.08|||Regression, Logistic|||Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.|
1692965|NCT01078298|3113584|Superiority or Other||Odds Ratio (OR)|1.98||||0.002|2-Sided|95.0|1.28|3.08|||Regression, Logistic|||For Week 52, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.|
1692966|NCT01078298|3113584|Superiority or Other||Odds Ratio (OR)|2.16||||0.0004|2-Sided|95.0|1.4|3.33|||Regression, Logistic|||For Week 24, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.|
1692967|NCT01078298|3113584|Superiority or Other||Odds Ratio (OR)|3.82|||<|0.0001|2-Sided|95.0|2.53|5.78|||Regression, Logistic|||For Week 12, odds ratio and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.|
1692968|NCT01078298|3113585|Superiority or Other||Odds Ratio (OR)|2.36||||0.0011|2-Sided|95.0|1.4|3.98|||Regression, Logistic|||For Week 9 through 52, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.|
1692969|NCT01078298|3113585|Superiority or Other||Odds Ratio (OR)|2.53||||0.0001|2-Sided|95.0|1.56|4.1|||Regression, Logistic|||For Week 9 through 24, odds ratio and p-value were calculated from logistic regression model including the main effects of treatment, pooled center and cohort.|
1692970|NCT01078298|3113586|Superiority or Other||Odds Ratio (OR)|3.35|||<|0.0001|2-Sided|95.0|2.16|5.21|||Regression, Logistic|||Odds Ratios and p-values were obtained from a logistic regression model including the main effects of treatment, pooled center and cohort.|
1692971|NCT01078246|3113587|Superiority or Other||Hazard Ratio (HR)|2.077||||0.107|2-Sided|95.0|0.854|5.05|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 3rd+ treatment regimen.|||
1692972|NCT01078246|3113587|Superiority or Other||Hazard Ratio (HR)|1.056||||0.881|2-Sided|95.0|0.517|2.155|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 2nd treatment regimen.|||
1692973|NCT01078246|3113587|Superiority or Other||Hazard Ratio (HR)|1.72||||0.125|2-Sided|95.0|0.861|3.437|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, and propensity score, and was stratified by the 1st treatment regimen.|||
1692974|NCT01078246|3113587|Superiority or Other||Hazard Ratio (HR)|1.564||||0.033|2-Sided|95.0|1.036|2.361|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692975|NCT01078246|3113587|Superiority or Other||Incidence Rate Ratio|1.556||||0.039|2-Sided|95.0|1.022|2.37|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692976|NCT01078246|3113587|Superiority or Other||Hazard Ratio (HR)|0.794||||0.356|2-Sided|95.0|0.486|1.296|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692977|NCT01078246|3113587|Superiority or Other||Incidence Rate Ratio|0.708||||0.109|2-Sided|95.0|0.464|1.08|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692978|NCT01078246|3113588|Superiority or Other||Hazard Ratio (HR)|1.022||||0.943|2-Sided|95.0|0.565|1.85|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692979|NCT01078246|3113588|Superiority or Other||Incidence Rate Ratio|0.845||||0.592|2-Sided|95.0|0.458|1.561|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692980|NCT01078246|3113588|Superiority or Other||Hazard Ratio (HR)|1.208||||0.631|2-Sided|95.0|0.559|2.612|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1693167|NCT01077596|3113774|Superiority or Other||Crude Odds Ratio|2.2||||||95.0|1.2|3.9|||||||
1692981|NCT01078246|3113588|Superiority or Other||Incidence Rate Ratio|0.75||||0.423|2-Sided|95.0|0.37|1.517|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692982|NCT01078246|3113589|Superiority or Other||Hazard Ratio (HR)|1.622||||0.018|2-Sided|95.0|1.085|2.425|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692983|NCT01078246|3113589|Superiority or Other||Incidence Rate Ratio|1.65||||0.015|2-Sided|95.0|1.102|2.47|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692984|NCT01078246|3113589|Superiority or Other||Hazard Ratio (HR)|0.471|||<|0.05|2-Sided|95.0|0.314|0.707|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692985|NCT01078246|3113589|Superiority or Other||Incidence Rate Ratio|0.389|||<|0.0001|2-Sided|95.0|0.274|0.551|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692986|NCT01078246|3113591|Superiority or Other||Hazard Ratio (HR)|1.057||||0.626|2-Sided|95.0|0.847|1.319|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692987|NCT01078246|3113591|Superiority or Other||Incidence Rate Ratio|1.067||||0.575|2-Sided|95.0|0.85|1.339|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692988|NCT01078246|3113591|Superiority or Other||Hazard Ratio (HR)|1.287||||0.07|2-Sided|95.0|0.98|1.69|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692989|NCT01078246|3113591|Superiority or Other||Incidence Rate Ratio|1.016||||0.897|2-Sided|95.0|0.796|1.297|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).|||
1692990|NCT01078246|3113592|Superiority or Other||Hazard Ratio (HR)|1.257||||0.188|2-Sided|95.0|0.894|1.768|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.|||
1692991|NCT01078246|3113592|Superiority or Other||Incidence Rate Ratio|1.268||||0.182|2-Sided|95.0|0.895|1.795|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.|||
1692992|NCT01078246|3113592|Superiority or Other||Hazard Ratio (HR)|0.907||||0.646|2-Sided|95.0|0.597|1.376|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.|||
1692993|NCT01078246|3113592|Superiority or Other||Incidence Rate Ratio|0.807||||0.255|2-Sided|95.0|0.557|1.168|||Poisson regression|The analysis included adjustments for raltegravir exposure, propensity score, treatment regimen (1st, 2nd, 3rd+), and Hepatitis B/C status.|||
1692994|NCT01078246|3113593|Superiority or Other||Hazard Ratio (HR)|1.86||||0.001|2-Sided|95.0|1.274|2.717|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies|
1692995|NCT01078246|3113593|Superiority or Other||Incidence Rate Ratio|1.776||||0.004|2-Sided|95.0|1.199|2.631|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies|
1692996|NCT01078246|3113593|Superiority or Other||Hazard Ratio (HR)|2.459||||0.001|2-Sided|95.0|1.454|4.159|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies|
1692997|NCT01078246|3113593|Superiority or Other||Incidence Rate Ratio|1.943||||0.008|2-Sided|95.0|1.191|3.168|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||Non-AIDS-defining malignancies|
1692998|NCT01078246|3113593|Superiority or Other||Hazard Ratio (HR)|1.879||||0.004|2-Sided|95.0|1.227|2.879|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies|
1692999|NCT01078246|3113593|Superiority or Other||Incidence Rate Ratio|1.871||||0.005|2-Sided|95.0|1.207|2.899|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies|
1693000|NCT01078246|3113593|Superiority or Other||Hazard Ratio (HR)|2.84|||<|0.05|2-Sided|95.0|1.621|4.977|||Cox Proportional Hazard Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies|
1693001|NCT01078246|3113593|Superiority or Other||Incidence Rate Ratio|2.282|||<|0.002|2-Sided|95.0|1.344|3.875|||Poisson Regression|The analysis included adjustments for raltegravir exposure, propensity score, and treatment regimen (1st, 2nd, 3rd+).||AIDS-defining malignancies|
1693002|NCT01078220|3113598|Superiority or Other||Relative Risk|0.78|||||2-Sided|95.0|0.5|1.21|||||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-60 after vaccination.|
1693003|NCT01078220|3113598|Superiority or Other||Relative Risk|1.02|||||2-Sided|95.0|0.53|1.98|||||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-14 after vaccination.|
1693004|NCT01078220|3113598|Superiority or Other||Relative Risk|1.05|||||2-Sided|95.0|0.82|1.35|||||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-60 after vaccination.|
1693005|NCT01078220|3113598|Superiority or Other||Relative Risk|1.64|||||2-Sided|95.0|1.17|2.3|||||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.|Days 1-14 after vaccination.|
1693006|NCT01078220|3113602|Superiority or Other||Relative Risk|2.88|||||2-Sided|95.0|1.18|7.08|||||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.||
1693007|NCT01078220|3113602|Superiority or Other||Relative Risk|6.0|||||2-Sided|95.0|3.91|9.21|||||Relative risk was approximated by odds ratio, obtained from conditional logistic regression.||
1694058|NCT01065454|3115345|Superiority or Other (legacy)||LS-MEANS Difference|-6.8|||||2-Sided|95.0|-12.81|-0.78|||||||
1693009|NCT01077973|3113640|Superiority or Other||Difference in proportion|5.46||||0.477|2-Sided|95.0|-9.66|20.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693010|NCT01077973|3113640|Superiority or Other||Difference in proportion|-6.4||||0.495|2-Sided|95.0|-25.14|12.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693011|NCT01077973|3113640|Superiority or Other||Difference in proportion|-0.87||||0.928|2-Sided|95.0|-20.0|18.27||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693012|NCT01077973|3113640|Superiority or Other||Difference in proportion|6.47||||0.288|2-Sided|95.0|-5.43|18.37||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693013|NCT01077973|3113640|Superiority or Other||Difference in proportion|-2.09||||0.765|2-Sided|95.0|-16.15|11.97||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693014|NCT01077973|3113640|Superiority or Other||Difference in proportion|4.43||||0.565|2-Sided|95.0|-10.43|19.29||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693015|NCT01077973|3113640|Superiority or Other||Difference in proportion|5.1||||0.094|2-Sided|95.0|-0.9|11.11||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693016|NCT01077973|3113640|Superiority or Other||Difference in proportion|-1.21||||0.623|2-Sided|95.0|-6.62|4.2||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference [Ibuprofen (Motrin IB) – placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693017|NCT01077973|3113640|Superiority or Other||Difference in proportion|3.89||||0.355|2-Sided|95.0|-3.33|11.1||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693018|NCT01077973|3113643|Superiority or Other||Difference in proportion|-1.65||||0.786|2-Sided|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693019|NCT01077973|3113643|Superiority or Other||Difference in proportion|-2.77||||0.689|2-Sided|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693020|NCT01077973|3113643|Superiority or Other||Difference in proportion|-4.25||||0.556|2-Sided|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693021|NCT01077973|3113643|Superiority or Other||Difference in proportion|-1.65||||0.786|2-Sided|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693022|NCT01077973|3113643|Superiority or Other||Difference in proportion|-2.77||||0.689|2-Sided|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693023|NCT01077973|3113643|Superiority or Other||Difference in proportion|-4.25||||0.556|2-Sided|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693233|NCT01076244|3113926|Superiority or Other||change from baseline|13.43|Standard Deviation|16.55|<|0.0001|2-Sided|95.0|8.42|18.43|||t-test, 2 sided||||
1693024|NCT01077973|3113643|Superiority or Other||Difference in proportion|-5.5||||0.45|2-Sided|95.0|-19.59|8.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693025|NCT01077973|3113643|Superiority or Other||Difference in proportion|-7.83||||0.331|2-Sided|95.0|-23.39|7.73||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference [Ibuprofen (Motrin IB) – placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693026|NCT01077973|3113643|Superiority or Other||Difference in proportion|-13.2||||0.13|2-Sided|95.0|-29.4|2.99||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693027|NCT01077973|3113643|Superiority or Other||Difference in proportion|1.47||||0.839|2-Sided|95.0|-12.6|15.55||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693028|NCT01077973|3113643|Superiority or Other||Difference in proportion|4.34||||0.612|2-Sided|95.0|-12.55|21.23||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693029|NCT01077973|3113643|Superiority or Other||Difference in proportion|6.06||||0.48|2-Sided|95.0|-10.86|22.99||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693030|NCT01077973|3113644|Superiority or Other||Difference in proportion|-1.65||||0.786|2-Sided|95.0|-13.45|10.14||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693031|NCT01077973|3113644|Superiority or Other||Difference in proportion|-2.77||||0.689|2-Sided|95.0|-16.24|10.69||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693032|NCT01077973|3113644|Superiority or Other||Difference in proportion|-4.25||||0.556|2-Sided|95.0|-17.82|9.33||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||3 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693033|NCT01077973|3113644|Superiority or Other||Difference in proportion|-1.65||||0.792|2-Sided|95.0|-13.8|10.5||p-value was calculated using CMH test which was adjusted which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693034|NCT01077973|3113644|Superiority or Other||Difference in proportion|-4.02||||0.57|2-Sided|95.0|-17.63|9.59||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693035|NCT01077973|3113644|Superiority or Other||Difference in proportion|-5.5||||0.455|2-Sided|95.0|-19.24|8.24||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||2 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693036|NCT01077973|3113644|Superiority or Other||Difference in proportion|-1.83||||0.813|2-Sided|95.0|-16.88|13.22||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693037|NCT01077973|3113644|Superiority or Other||Difference in proportion|-5.66||||0.537|2-Sided|95.0|-23.57|12.25||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference [Ibuprofen (Motrin IB) – placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693038|NCT01077973|3113644|Superiority or Other||Difference in proportion|-7.52||||0.427|2-Sided|95.0|-25.96|10.92||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||1 hour: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693312|NCT01075685|3114053|Superiority or Other|||||||0.0279|||||||Type 3 tests of fixed effects||||
1696415|NCT01033942|3118856|Superiority or Other|||||||0.7573|||||||Fisher Exact||||
1693039|NCT01077973|3113644|Superiority or Other||Difference in proportion|7.55||||0.164|2-Sided|95.0|-2.96|18.05||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693040|NCT01077973|3113644|Superiority or Other||Difference in proportion|-4.47||||0.467|2-Sided|95.0|-17.61|8.68||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and its associated 95% CI was calculated based on CMH adjusted proportions and the corresponding standard error.|
1693041|NCT01077973|3113644|Superiority or Other||Difference in proportion|3.02||||0.672|2-Sided|95.0|-11.03|17.07||p-value was calculated using CMH test which was adjusted for baseline PSR, and gender. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||0.5 hours: Treatment difference (Ibuprofen sodium – placebo) and its associated 95% CI was calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportions and the corresponding standard error.|
1693042|NCT01077973|3113645|Superiority or Other||LS mean difference|-0.44||||0.624|2-Sided|95.0|-2.19|1.31||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693043|NCT01077973|3113645|Superiority or Other||LS mean difference|-0.68||||0.526|2-Sided|95.0|-2.8|1.43||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-3: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693044|NCT01077973|3113645|Superiority or Other||LS mean difference|-0.19||||0.733|2-Sided|95.0|-1.31|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693045|NCT01077973|3113645|Superiority or Other||LS mean difference|-0.53||||0.439|2-Sided|95.0|-1.87|0.82||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693046|NCT01077973|3113645|Superiority or Other||LS mean difference|-0.72||||0.292|2-Sided|95.0|-2.07|0.62||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPRID 0-2: Treatment difference (Ibuprofen sodium – placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693047|NCT01077973|3113646|Superiority or Other||LS mean difference|-0.23||||0.691|2-Sided|95.0|-1.38|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693048|NCT01077973|3113646|Superiority or Other||LS mean difference|-0.47||||0.506|2-Sided|95.0|-1.86|0.92||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693049|NCT01077973|3113646|Superiority or Other||LS mean difference|-0.7||||0.32|2-Sided|95.0|-2.09|0.69||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-3: Treatment difference (Ibuprofen sodium – placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693050|NCT01077973|3113646|Superiority or Other||LS mean difference|-0.13||||0.726|2-Sided|95.0|-0.88|0.61||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693051|NCT01077973|3113646|Superiority or Other||LS mean difference|-0.32||||0.489|2-Sided|95.0|-1.21|0.58||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693052|NCT01077973|3113646|Superiority or Other||LS mean difference|-0.45||||0.327|2-Sided|95.0|-1.35|0.45||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||TOTPAR 0-2: Treatment difference (Ibuprofen sodium – placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693053|NCT01077973|3113647|Superiority or Other||LS mean difference|-0.2||||0.523|2-Sided|95.0|-0.83|0.42||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693054|NCT01077973|3113647|Superiority or Other||LS mean difference|-0.21||||0.582|2-Sided|95.0|-0.97|0.55||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693055|NCT01077973|3113647|Superiority or Other||LS mean difference|-0.42||||0.281|2-Sided|95.0|-1.17|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-3: Treatment difference (Ibuprofen sodium – placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693056|NCT01077973|3113647|Superiority or Other||LS mean difference|-0.06||||0.762|2-Sided|95.0|-0.45|0.33||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693057|NCT01077973|3113647|Superiority or Other||LS mean difference|-0.21||||0.378|2-Sided|95.0|-0.69|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693058|NCT01077973|3113647|Superiority or Other||LS mean difference|-0.27||||0.259|2-Sided|95.0|-0.75|0.2||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||SPID 0-2: Treatment difference (Ibuprofen sodium – placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693059|NCT01077973|3113648|Superiority or Other||LS mean difference|-0.24||||0.493|2-Sided|95.0|-0.94|0.46||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693060|NCT01077973|3113648|Superiority or Other||LS mean difference|-0.15||||0.722|2-Sided|95.0|-1.0|0.69||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693061|NCT01077973|3113648|Superiority or Other||LS mean difference|-0.4||||0.356|2-Sided|95.0|-1.24|0.45||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium – placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693062|NCT01077973|3113648|Superiority or Other||LS mean difference|-0.23||||0.471|2-Sided|95.0|-0.85|0.39||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693063|NCT01077973|3113648|Superiority or Other||LS mean difference|-0.19||||0.616|2-Sided|95.0|-0.94|0.56||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693064|NCT01077973|3113648|Superiority or Other||LS mean difference|-0.42||||0.273|2-Sided|95.0|-1.17|0.33||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium – placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693065|NCT01077973|3113648|Superiority or Other||LS mean difference|0.03||||0.902|2-Sided|95.0|-0.52|0.59||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693066|NCT01077973|3113648|Superiority or Other||LS mean difference|-0.34||||0.324|2-Sided|95.0|-1.01|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693067|NCT01077973|3113648|Superiority or Other||LS mean difference|-0.3||||0.377|2-Sided|95.0|-0.98|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium – placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693068|NCT01077973|3113649|Superiority or Other||LS mean difference|-0.14||||0.287|2-Sided|95.0|-0.41|0.12||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693069|NCT01077973|3113649|Superiority or Other||LS mean difference|0.0||||0.995|2-Sided|95.0|-0.32|0.32||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693070|NCT01077973|3113649|Superiority or Other||LS mean difference|-0.14||||0.382|2-Sided|95.0|-0.46|0.18||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium – placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693442|NCT01074008|3114324|Superiority or Other||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693071|NCT01077973|3113649|Superiority or Other||LS mean difference|-0.1||||0.393|2-Sided|95.0|-0.32|0.13||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693072|NCT01077973|3113649|Superiority or Other||LS mean difference|-0.07||||0.63|2-Sided|95.0|-0.34|0.2||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693073|NCT01077973|3113649|Superiority or Other||LS mean difference|-0.16||||0.235|2-Sided|95.0|-0.43|0.11||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium – placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693074|NCT01077973|3113649|Superiority or Other||LS mean difference|0.04||||0.72|2-Sided|95.0|-0.17|0.24||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693075|NCT01077973|3113649|Superiority or Other||LS mean difference|-0.15||||0.242|2-Sided|95.0|-0.39|0.1||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693076|NCT01077973|3113649|Superiority or Other||LS mean difference|-0.11||||0.382|2-Sided|95.0|-0.36|0.14||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium – placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693077|NCT01077973|3113650|Superiority or Other||LS mean difference|-0.1||||0.657|2-Sided|95.0|-0.54|0.34||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693078|NCT01077973|3113650|Superiority or Other||LS mean difference|-0.15||||0.573|2-Sided|95.0|-0.69|0.38||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693079|NCT01077973|3113650|Superiority or Other||LS mean difference|-0.25||||0.352|2-Sided|95.0|-0.79|0.28||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||3 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693080|NCT01077973|3113650|Superiority or Other||LS mean difference|-0.13||||0.533|2-Sided|95.0|-0.54|0.28||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693081|NCT01077973|3113650|Superiority or Other||LS mean difference|-0.12||||0.621|2-Sided|95.0|-0.62|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693082|NCT01077973|3113650|Superiority or Other||LS mean difference|-0.25||||0.313|2-Sided|95.0|-0.75|0.24||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693083|NCT01077973|3113650|Superiority or Other||LS mean difference|0.0||||0.991|2-Sided|95.0|-0.38|0.37||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen sodium – Ibuprofen (Motrin IB)] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693084|NCT01077973|3113650|Superiority or Other||LS mean difference|-0.19||||0.407|2-Sided|95.0|-0.64|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference [Ibuprofen (Motrin IB) – placebo] and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693085|NCT01077973|3113650|Superiority or Other||LS mean difference|-0.19||||0.402|2-Sided|95.0|-0.65|0.26||p-value was calculated using ANOVA which was adjusted for treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium - placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1693086|NCT01077973|3113651|Superiority or Other||Hazard Ratio (HR)|0.73||||0.108|2-Sided|95.0|0.49|1.07||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1693443|NCT01074008|3114324|Superiority or Other||||||<|0.005||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693087|NCT01077973|3113651|Superiority or Other||Hazard Ratio (HR)|0.9||||0.652|2-Sided|95.0|0.58|1.41||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1693088|NCT01077973|3113651|Superiority or Other||Hazard Ratio (HR)|0.66||||0.072|2-Sided|95.0|0.41|1.04||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1693089|NCT01077973|3113652|Superiority or Other||Hazard Ratio (HR)|1.02||||0.936|2-Sided|95.0|0.65|1.59||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1693090|NCT01077973|3113652|Superiority or Other||Hazard Ratio (HR)|0.79||||0.304|2-Sided|95.0|0.5|1.24||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||HR and corresponding 95% CI were calculated based on the Wald statistic from the PH model.|
1693091|NCT01077973|3113653|Superiority or Other||Hazard Ratio (HR)|0.77||||0.193|2-Sided|95.0|0.52|1.14||p-value was calculated using the PH model with treatment, baseline PSR, gender, and treatment-by-baseline terms. Statistical testing was done at 5% significance level (2-sided).|Proportional hazards model|||Hazard Ratio (HR) and corresponding 95% CI were calculated based on the Wald statistic from the proportional hazards (PH) model. Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium vs. placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.|
1693092|NCT01077973|3113654|Superiority or Other||Least-square (LS) mean difference|-1.12||||0.299|2-Sided|95.0|-3.23|1.0||p-value was calculated using ANOVA model with treatment, baseline Pain Severity Rating (PSR), gender and treatment-by-baseline PSR terms.|ANOVA|||Treatment difference (Ibuprofen sodium-placebo) and 95 percent (%) confidence interval (CI): based on LS means from analysis of variance (ANOVA). Type I error was controlled at 0.05 significance level (2-sided) by stating pair wise comparisons significant only if overall treatment effect among 3 treatment groups was significant and testing in a sequential order Ibuprofen sodium versus (vs.) placebo for SPRID 0-3 then Ibuprofen sodium vs. Ibuprofen (Motrin IB) for time to meaningful relief.|
1693093|NCT01077960|3113655|Superiority or Other|||||||0.015|||||||t-test, 2 sided||||
1693094|NCT01077960|3113656|Superiority or Other|||||||0.007|||||||t-test, 2 sided||||
1693095|NCT01077960|3113657|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1693096|NCT01077960|3113658|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1693097|NCT01077960|3113659|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1693098|NCT01077960|3113660|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1693099|NCT01077856|3113678|Superiority or Other||Standardized Prevalence Ratio (SPR)|0.86|||||2-Sided|95.0|0.0|2.02|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)||
1693100|NCT01077856|3113678|Superiority or Other||Standardized Prevalence Ratio (SPR)|1.59|||||2-Sided|95.0|0.0|4.77|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)||
1693101|NCT01077856|3113678|Superiority or Other||Standardized Prevalence Ratio (SPR)|1.34|||||2-Sided|95.0|0.89|2.0|||||SPR is the age-adjusted ratio of percentage of live births with a major congenital anomaly (Women who received Gardasil / Women in the general population)||
1693102|NCT01077830|3113703|Superiority or Other||Hazard Ratio (HR)|0.55|||||2-Sided|95.0|0.27|1.11|||||Hazard Ratio obtained by dividing the crude rate of new cancers reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of newly diagnosed cancers in the the Placebo arm||
1693103|NCT01077830|3113704|Superiority or Other||Hazard Ratio (HR)|1.36|||||2-Sided|95.0|0.3|6.06|||||Hazard Ratio obtained by dividing the crude rate of death from cancer reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of death from cancer in the Placebo arm||
1693104|NCT01077830|3113705|Superiority or Other||Hazard Ratio (HR)|1.33|||||2-Sided|95.0|0.84|2.09|||||Hazard Ratio obtained by dividing the crude rate of death (any cause) reported in the Ezetimibe/Simvastatin 10/40 arm by the crude rate of death (any cause) in the Placebo arm||
1693105|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.2|3.9||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene~compared to non-initiators of raloxifene. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."|
1693106|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|1.0|||||2-Sided|95.0|0.4|2.5||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risedronate~compared to non-initiators of risedronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."|
1693107|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|1.1|||||2-Sided|95.0|0.6|2.0||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate~compared to non-initiators of etidronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."|
1693108|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|0.9|||||2-Sided|95.0|0.5|1.6||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate~compared to non-initiators of alendronate. For calculation of 1441+ day hazard ratios, only esophageal cancer cases occurring at least 1441 days from initiation of study drug (data not shown) were used."|
1693444|NCT01074008|3114324|Superiority or Other||||||<|0.005||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693109|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|0.6|||||2-Sided|95.0|0.1|2.7||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~raloxifene compared to non-initiators of raloxifene. For calculation of 721+ day hazard ratios, only~esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."|
1693110|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|1.8|||||2-Sided|95.0|1.1|3.0||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~risedronate compared to non-initiators of risedronate. For calculation of 721+ day hazard ratios,~only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."|
1693111|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|3.0|||||2-Sided|95.0|0.8|11.1||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~ibandronate compared to non-initiators of ibandronate. For calculation of 721+ day hazard ratios,~only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."|
1693112|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|1.2|||||2-Sided|95.0|0.7|1.9||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~etidronate compared to non-initiators of etidronate. For calculation of 721+ day hazard ratios, only~esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."|
1693113|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|1.0|||||2-Sided|95.0|0.7|1.5||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of~alendronate compared to non-initiators of alendronate. For calculation of 721+ day hazard ratios, only esophageal cancer cases occurring at least 721 days from initiation of study drug (data not shown) were used."|
1693114|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|0.9|||||2-Sided|95.0|0.3|2.3||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of raloxifene~compared to non-initiators of raloxifene. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."|
1693115|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|1.3|||||2-Sided|95.0|0.9|2.0||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of risendronate~compared to non-initiators of risendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."|
1693116|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|1.3|||||2-Sided|95.0|0.5|3.4||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of ibandronate~compared to non-initiators of ibandronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."|
1693117|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|1.3|||||2-Sided|95.0|0.8|2.0||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of etidronate~compared to non-initiators of etidronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."|
1693118|NCT01077817|3113706|Superiority or Other||Hazard Ratio (HR)|1.0|||||2-Sided|95.0|0.7|1.3||||||"A hazard ratio was calculated to estimate the risk of esophageal cancer among initiators of alendronate~compared to non-initiators of alendronate. For calculation of this hazard ratio, esophageal cancer cases occurring during the entire follow-up period were used."|
1693119|NCT01077817|3113707|Superiority or Other||Hazard Ratio (HR)|0.7|||||2-Sided|95.0|0.2|2.2||||||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to raloxifene treatment and incidence of esophageal cancer.|
1693120|NCT01077817|3113707|Superiority or Other||Hazard Ratio (HR)|1.6|||||2-Sided|95.0|1.0|2.5||||||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to risedronate treatment and incidence of esophageal cancer.|
1693121|NCT01077817|3113707|Superiority or Other||Hazard Ratio (HR)|4.9|||||2-Sided|95.0|1.4|16.7||||||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to ibandronate treatment and incidence of esophageal cancer.|
1693122|NCT01077817|3113707|Superiority or Other||Hazard Ratio (HR)|1.3|||||2-Sided|95.0|0.9|2.0||||||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to etidronate treatment and incidence of esophageal cancer.|
1693123|NCT01077817|3113707|Superiority or Other||Hazard Ratio (HR)|1.1|||||2-Sided|95.0|0.7|1.5||||||A hazard ratio estimate was calculated from the case-control matched set to measure the risk association between exposure to alendronate treatment and incidence of esophageal cancer.|
1693124|NCT01077622|3113767|Superiority or Other||percentage of participants|70.0|||||2-Sided|95.0|34.8|93.3|||||Investigator assessment||
1693125|NCT01077622|3113767|Superiority or Other||percentage of participants|70.0|||||2-Sided|95.0|34.8|93.3|||||SERC assessment||
1693126|NCT01077596|3113769|Superiority or Other||Adjusted Odds Ratio|1.0||||||95.0|0.8|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693127|NCT01077596|3113769|Superiority or Other||Crude Odds Ratio|1.0||||||95.0|0.9|1.2|||||||
1693128|NCT01077596|3113769|Superiority or Other||Adjusted Odds Ratio|1.1||||||95.0|0.9|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693129|NCT01077596|3113769|Superiority or Other||Crude Odds Ratio|1.1||||||95.0|0.9|1.2|||||||
1693130|NCT01077596|3113769|Superiority or Other||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693131|NCT01077596|3113769|Superiority or Other||Crude Odds Ratio|1.2||||||95.0|1.0|1.4|||||||
1693132|NCT01077596|3113769|Superiority or Other||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693133|NCT01077596|3113769|Superiority or Other||Crude Odds Ratio|1.1||||||95.0|1.0|1.3|||||||
1693134|NCT01077596|3113770|Superiority or Other||Adjusted Odds Ratio|1.1||||||95.0|0.9|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693135|NCT01077596|3113770|Superiority or Other||Crude Odds Ratio|1.1||||||95.0|0.9|1.3|||||||
1693136|NCT01077596|3113770|Superiority or Other||Adjusted Odds Ratio|0.9||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693137|NCT01077596|3113770|Superiority or Other||Crude Odds Ratio|1.0||||||95.0|0.8|1.1|||||||
1693138|NCT01077596|3113770|Superiority or Other||Adjusted Odds Ratio|1.0||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693139|NCT01077596|3113770|Superiority or Other||Crude Odds Ratio|1.0||||||95.0|0.9|1.2|||||||
1693140|NCT01077596|3113770|Superiority or Other||Adjusted Odds Ratio|0.9||||||95.0|0.8|1.1|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693141|NCT01077596|3113770|Superiority or Other||Crude Odds Ratio|0.9||||||95.0|0.8|1.1|||||||
1693142|NCT01077596|3113771|Superiority or Other||Adjusted Odds Ratio|1.0||||||95.0|0.6|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status†, previous depression dx, previous IBD‡ diagnosis, OC§ use, HRT/ERT use, and NSAID use.||
1693143|NCT01077596|3113771|Superiority or Other||Crude Odds Ratio|1.1||||||95.0|0.6|2.0|||||||
1693144|NCT01077596|3113771|Superiority or Other||Adjusted Odds Ratio|0.8||||||95.0|0.4|1.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693145|NCT01077596|3113771|Superiority or Other||Crude Odds Ratio|0.8||||||95.0|0.5|1.4|||||||
1693146|NCT01077596|3113771|Superiority or Other||Adjusted Odds Ratio|0.6||||||95.0|0.3|1.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693147|NCT01077596|3113771|Superiority or Other||Crude Odds Ratio|0.6||||||95.0|0.4|1.1|||||||
1693148|NCT01077596|3113771|Superiority or Other||Adjusted Odds Ratio|0.7||||||95.0|0.4|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693149|NCT01077596|3113771|Superiority or Other||Crude Odds Ratio|0.8||||||95.0|0.5|1.3|||||||
1693150|NCT01077596|3113772|Superiority or Other||Adjusted Odds Ratio|2.2||||||95.0|1.3|3.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693151|NCT01077596|3113772|Superiority or Other||Crude Odds Ratio|2.6||||||95.0|1.5|4.5|||||||
1693152|NCT01077596|3113772|Superiority or Other||Adjusted Odds Ratio|1.8||||||95.0|1.1|3.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693153|NCT01077596|3113772|Superiority or Other||Crude Odds Ratio|2.3||||||95.0|1.5|3.7|||||||
1693154|NCT01077596|3113772|Superiority or Other||Adjusted Odds Ratio|1.8||||||95.0|1.1|3.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693155|NCT01077596|3113772|Superiority or Other||Crude Odds Ratio|2.3||||||95.0|1.4|3.6|||||||
1693156|NCT01077596|3113772|Superiority or Other||Adjusted Odds Ratio|2.1||||||95.0|1.3|3.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693157|NCT01077596|3113772|Superiority or Other||Crude Odds Ratio|2.6||||||95.0|1.7|4.1|||||||
1693158|NCT01077596|3113773|Superiority or Other||Adjusted Odds Ratio|3.5||||||95.0|2.1|5.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693159|NCT01077596|3113773|Superiority or Other||Crude Odds Ratio|4.5||||||95.0|2.8|7.2|||||||
1693160|NCT01077596|3113773|Superiority or Other||Adjusted Odds Ratio|3.0||||||95.0|1.9|4.5|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693161|NCT01077596|3113773|Superiority or Other||Crude Odds Ratio|4.4||||||95.0|3.1|6.3|||||||
1693162|NCT01077596|3113773|Superiority or Other||Adjusted Odds Ratio|2.9||||||95.0|1.9|4.5|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693163|NCT01077596|3113773|Superiority or Other||Crude Odds Ratio|4.0||||||95.0|2.8|5.8|||||||
1693164|NCT01077596|3113773|Superiority or Other||Adjusted Odds Ratio|3.0||||||95.0|2.0|4.4|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693165|NCT01077596|3113773|Superiority or Other||Crude Odds Ratio|4.5||||||95.0|3.2|6.3|||||||
1693166|NCT01077596|3113774|Superiority or Other||Adjusted Odds Ratio|2.0||||||95.0|1.1|3.6|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693168|NCT01077596|3113774|Superiority or Other||Adjusted Odds Ratio|1.1||||||95.0|0.7|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693169|NCT01077596|3113774|Superiority or Other||Crude Odds Ratio|1.3||||||95.0|0.8|2.1|||||||
1693170|NCT01077596|3113774|Superiority or Other||Adjusted Odds Ratio|1.1||||||95.0|0.7|1.9|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693171|NCT01077596|3113774|Superiority or Other||Crude Odds Ratio|1.2||||||95.0|0.8|2.0|||||||
1693172|NCT01077596|3113774|Superiority or Other||Adjusted Odds Ratio|1.2||||||95.0|0.8|2.0|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693173|NCT01077596|3113774|Superiority or Other||Crude Odds Ratio|1.4||||||95.0|0.9|2.2|||||||
1693174|NCT01077596|3113775|Superiority or Other||Adjusted Odds Ratio|1.2||||||95.0|1.0|1.3|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693175|NCT01077596|3113775|Superiority or Other||Crude Odds Ratio|1.2||||||95.0|1.1|1.4|||||||
1693176|NCT01077596|3113775|Superiority or Other||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693177|NCT01077596|3113775|Superiority or Other||Crude Odds Ratio|1.2||||||95.0|1.0|1.3|||||||
1693178|NCT01077596|3113775|Superiority or Other||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693179|NCT01077596|3113775|Superiority or Other||Crude Odds Ratio|1.2||||||95.0|1.1|1.3|||||||
1693180|NCT01077596|3113775|Superiority or Other||Adjusted Odds Ratio|1.1||||||95.0|1.0|1.2|||||Adjusted for age, sex, cal year, study site, tumor characteristics, multiple antidepressants exposure, smoking, hysterectomy status, previous depression dx, previous IBD diagnosis, OC use, HRT/ERT use, and NSAID use.||
1693181|NCT01077596|3113775|Superiority or Other||Crude Odds Ratio|1.2||||||95.0|1.1|1.3|||||||
1693182|NCT01077518|3113809|Superiority||Hazard Ratio (HR)|0.83||||0.3768|2-Sided|95.0|0.55|1.25|||Stratified Log Rank|||for FL participants|
1693183|NCT01077518|3113810|Other||Hazard Ratio (HR)|0.87||||0.4046|2-Sided|95.0|0.62|1.21|||Stratified Log Rank|||for All patients|
1693184|NCT01077518|3113811|Other|||||||0.613|||||||Cochran-Mantel-Haenszel|adjusted for stratum||for Follicular Lymphoma (FL) participants|
1693185|NCT01077518|3113812|Other|||||||0.8003|||||||Cochran-Mantel-Haenszel|adjusted for stratum||for All participants|
1693186|NCT01077518|3113813|Other||Stratified Cox propor.hazards regression|0.76||||0.1076|2-Sided|95.0|0.55|1.06|||Stratified Log-Rank||||
1693187|NCT01077518|3113814|Superiority||Stratified Cox propor.hazards regression|0.82||||0.139|2-Sided|95.0|0.62|1.07|||Stratified Log-Rank||||
1693188|NCT01077362|3113820|Superiority or Other|||||||0.094|||||||re-randomization||||
1693189|NCT01077362|3113820|Superiority or Other|||||||0.06|||||||re-randomization test||||
1693190|NCT01077362|3113820|Superiority or Other|||||||0.171|||||||re-randomization||||
1693191|NCT01077362|3113821|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1693192|NCT01077362|3113821|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1693193|NCT01077362|3113821|Superiority or Other||||||<|0.017|||||||re-randomization test||||
1693194|NCT01077362|3113822|Superiority or Other|||||||0.002|||||||re-randomization test||||
1693195|NCT01077362|3113822|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1693196|NCT01077362|3113822|Superiority or Other||||||<|0.018|||||||re-randomization test||||
1693197|NCT01077362|3113823|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1693198|NCT01077362|3113823|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1693199|NCT01077362|3113823|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1693200|NCT01077362|3113824|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1693201|NCT01077362|3113824|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1693202|NCT01077362|3113824|Superiority or Other||||||<|0.002|||||||re-randomization test||||
1693203|NCT01077362|3113825|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1693204|NCT01077362|3113825|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1693205|NCT01077362|3113825|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1693206|NCT01077323|3113826|Superiority or Other||Adjusted Rate Ratio (ARR)|1.39|||||2-Sided|95.0|0.86|2.25|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."||
1693207|NCT01077323|3113827|Superiority or Other||Adjusted Rate Ratio (ARR)|0.87|||||2-Sided|95.0|0.36|2.09|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."||
1693208|NCT01077323|3113828|Superiority or Other||Adjusted Rate Ratio (ARR)|1.1|||||2-Sided|95.0|0.8|1.5|||||ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.Rate ratios adjusted for propensity score of exenatide initiation using Cox Proportional Hazards Regression||
1693445|NCT01074008|3114337|Superiority or Other|||||||0.013||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693209|NCT01077323|3113829|Superiority or Other||Adjusted Rate Ratio (ARR)|0.87|||||2-Sided|95.0|0.59|1.28|||||"ARR equals adjusted incidence rate of acute pancreatitis in exenatide cohort divided by adjusted incidence of acute pancreatitis in OAD cohort.~Adjusted incidence rates were calculated using a Poisson regression model adjusted for propensity score."||
1693210|NCT01077284|3113835|Superiority or Other|||||||0.94||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|ANOVA|P-values are from ANOVA with treatment as a fixed effect.|||
1693211|NCT01077284|3113835|Superiority or Other|||||||0.5535||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|ANOVA|P-values are from ANOVA with treatment as a fixed effect.|||
1693212|NCT01077284|3113836|Superiority or Other|||||||0.413||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)||||
1693213|NCT01077284|3113836|Superiority or Other|||||||0.403||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)||||
1693214|NCT01077284|3113837|Superiority or Other|||||||0.348||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)||||
1693215|NCT01077284|3113837|Superiority or Other|||||||0.13||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)||||
1693216|NCT01077284|3113838|Superiority or Other|||||||0.003||||||Hochberg's method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)||||
1693217|NCT01077284|3113838|Superiority or Other||||||<|0.001||||||Hochberg’s method for multiple comparisons was used to ensure that the overall 0.050 level of significance was maintained for comparisons of febuxostat to allopurinol and to placebo.|Wilcoxon (Mann-Whitney)||||
1693218|NCT01077193|3113862|Non-Inferiority or Equivalence|See above.|Mean Percent Excess Weight Loss|37.9|Standard Deviation|25.18||0.3227|2-Sided|95.0|30.2|45.5||No multiple comparison adjustments are necessary as this is a single hypothesis on 1 parameter for a within group change comparison to 36.1%.|t-test, 1 sided|||A sample size of 32 achieves power>90% to demonstrate non-inferiority using a one-sided t-test (alpha=0.025) when the margin of equivalence is a 5% difference in EWL. The true difference between %EWL for patients undergoing a greater curvature procedure and the target %EWL is hypothesized to be 0. The target %EWL at 3 years is 41.1%, based upon prior studies. This power analysis assumes data are drawn from a single population with a standard deviation of 8.20.|
1693219|NCT01077154|3113863|Superiority||Hazard Ratio (HR)|1.06||||0.41|2-Sided|95.0|0.92|1.21|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio < 1 favors denosumab.||
1693220|NCT01077154|3113864|Superiority||Hazard Ratio (HR)|1.01||||0.94|2-Sided|95.0|0.83|1.22|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio < 1 favors denosumab.||
1693221|NCT01077154|3113865|Superiority||Hazard Ratio (HR)|1.12||||0.26|2-Sided|95.0|0.92|1.36|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio < 1 favors denosumab.||
1693222|NCT01077154|3113866|Superiority||Hazard Ratio (HR)|1.04||||0.57|2-Sided|95.0|0.91|1.19|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hzard ratio < 1 favors denosumab.||
1693223|NCT01077154|3113867|Superiority||Hazard Ratio (HR)|0.97||||0.7|2-Sided|95.0|0.82|1.14|||Stratified Log Rank|Stratified by breast cancer therapy/LN status, hormone receptor status, HER-2 status, age, and geographic region.|Based on a Cox proportional hazards model stratified by the randomization stratification factors; a hazard ratio < 1 favors denosumab.||
1693224|NCT01077050|3113877|Superiority or Other||Odds Ratio (OR)|13.0|||<|0.0001|2-Sided|95.0|6.6|25.5|||Mixed Models Analysis|Note that calculating odds ratio adjusting for subjects having multiple lesions, yields similar result.|||
1693225|NCT01077050|3113877|Superiority or Other||Observed sensitivity for squamous cell c|93.3|||<||2-Sided|95.0|68.1|99.8|||||||
1693226|NCT01077050|3113877|Superiority or Other||Sensitivity to Basal Cell Carcinoma|100.0|||<||2-Sided|95.0|92.6|100.0|||||||
1693227|NCT01077050|3113877|Superiority or Other||Sensitivity to Melanoma|96.6|||<||1-Sided|95.0|94.2||||||||
1693228|NCT01076543|3113900|Superiority||||||<|0.1|||||||Binomial exact test.|The number of responders required to reject the null hypothesis was 16 or more.||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 30% vs. a 50% alternative.|
1693229|NCT01076543|3113900|Superiority||||||<|||||||||||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 50% vs. 70% alternative.|The follicular subgroup did not reach its accrual goal and was closed.
1693230|NCT01076543|3113900|Superiority||||||>|0.1|||||||Binomial exact test|The number of responders required to reject the null hypothesis was 16 or more.||Two-stage, minimax design was used to test the null hypothesis that the overall response rate was 30% vs. a 50% alternative.|
1693231|NCT01076543|3113902|Other||Maximum tolerated dose in mg|20.0|||||2-Sided||||||||"The maximum tolerated dose (MTD) was determined using the traditional 3+3 design and was the maximum dose level such that less than 33% of the patients (i.e, <1 of 3 or <2 of 6) experience dose-limiting toxicity."||
1693232|NCT01076244|3113924|Superiority or Other||change from baseline|2.17|Standard Deviation|3.29|<|0.0001|2-Sided|95.0|1.17|3.16|||t-test, 2 sided||||
1693234|NCT01076088|3113987|Superiority or Other||Difference in Least Squares Mean|-9.93||||0.027|2-Sided|95.0|-18.72|-1.14||Pairwise comparison, sitagliptin 100 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.|||
1693235|NCT01076088|3113987|Superiority or Other||Difference in Least Squares Mean|-21.73|||<|0.001|2-Sided|95.0|-30.42|-13.04||Pairwise comparison, metformin 500 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.|||
1693236|NCT01076088|3113987|Superiority or Other||Difference in Least Squares Mean|-27.45|||<|0.001|2-Sided|95.0|-36.18|-18.73||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.|||
1693237|NCT01076088|3113987|Superiority or Other||Difference in Least Squares Mean|-27.7|||<|0.001|2-Sided|95.0|-36.4|-19.0||Pairwise comparison, metformin 850 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.|||
1693238|NCT01076088|3113987|Superiority or Other||Difference in Least Squares Mean|-35.81|||<|0.001|2-Sided|95.0|-44.56|-27.06||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.|||
1693239|NCT01076088|3113987|Superiority or Other||Difference in Least Squares Mean|-17.53|||<|0.001|2-Sided|95.0|-26.33|-8.72||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.|||
1693240|NCT01076088|3113987|Superiority or Other||Difference in Least Squares Mean|-5.72|||<|0.198|2-Sided|95.0|-14.44|3.0||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.|||
1693241|NCT01076088|3113987|Superiority or Other||Difference in Least Squares Mean|-25.88|||<|0.001|2-Sided|95.0|-34.72|-17.04||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.|||
1693242|NCT01076088|3113987|Superiority or Other||Difference in Least Squares Mean|-8.11|||<|0.069|2-Sided|95.0|-16.86|0.64||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline FPG.|||
1693243|NCT01076088|3113988|Superiority or Other||Difference in Least Squares Mean|-26.23|||<|0.001|2-Sided|95.0|-41.62|-10.84||Pairwise comparison, sitagliptin 100 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.|||
1693244|NCT01076088|3113988|Superiority or Other||Difference in Least Squares Mean|-43.79|||<|0.001|2-Sided|95.0|-58.99|-28.58||Pairwise comparison, metformin 500 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.|||
1693245|NCT01076088|3113988|Superiority or Other||Difference in Least Squares Mean|-75.17|||<|0.001|2-Sided|95.0|-90.47|-59.87||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.|||
1693246|NCT01076088|3113988|Superiority or Other||Difference in Least Squares Mean|-69.05|||<|0.001|2-Sided|95.0|-84.41|-53.7||Pairwise comparison, metformin 850 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.|||
1693247|NCT01076088|3113988|Superiority or Other||Difference in Least Squares Mean|-87.57|||<|0.001|2-Sided|95.0|-102.87|-72.27||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.|||
1693248|NCT01076088|3113988|Superiority or Other||Difference in Least Squares Mean|-48.94|||<|0.001|2-Sided|95.0|-64.21|-33.67||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.|||
1693249|NCT01076088|3113988|Superiority or Other||Difference in Least Squares Mean|-31.38|||<|0.001|2-Sided|95.0|-46.49|-16.28||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.|||
1693250|NCT01076088|3113988|Superiority or Other||Difference in Least Squares Mean|-61.34|||<|0.001|2-Sided|95.0|-76.61|-46.07||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.|||
1693251|NCT01076088|3113988|Superiority or Other||Difference in Least Squares Mean|-18.52|||<|0.017|2-Sided|95.0|-33.75|-3.29||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline 2-H PMG.|||
1693252|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-0.39||||0.004|2-Sided|95.0|-0.65|-0.12||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693253|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-0.64|||<|0.001|2-Sided|95.0|-0.9|-0.37||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1694059|NCT01065454|3115346|Superiority or Other (legacy)||LS-MEANS Difference|0.02|||||2-Sided|95.0|-0.07|0.11|||||||
1693254|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-1.0|||<|0.001|2-Sided|95.0|-1.26|-0.74||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693255|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-0.9|||<|0.001|2-Sided|95.0|-1.16|-0.63||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693256|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-1.25|||<|0.001|2-Sided|95.0|-1.52|-0.99||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693257|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-0.61|||<|0.001|2-Sided|95.0|-0.88|-0.35||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693258|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-0.36|||<|0.007|2-Sided|95.0|-0.63|-0.1||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693259|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-0.87|||<|0.001|2-Sided|95.0|-1.13|-0.6||Comparing co-administration with individual components. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693260|NCT01076088|3113989|Superiority or Other||Difference in least squares mean|-0.36|||<|0.008|2-Sided|95.0|-0.62|-0.09||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. This is a post-hoc analysis using robust regression, a valid method in the presence of outliers.|Regression, Robust|The Robust Regression model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693261|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-0.4|||<|0.011|2-Sided|95.0|-0.71|-0.09||Pairwise comparison, sitagliptin 100 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693262|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-0.7|||<|0.001|2-Sided|95.0|-1.01|-0.39||Pairwise comparison, metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693263|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-1.08|||<|0.001|2-Sided|95.0|-1.39|-0.78||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693264|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-0.97|||<|0.001|2-Sided|95.0|-1.28|-0.66||Pairwise comparison, metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693265|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-1.24|||<|0.001|2-Sided|95.0|-1.55|-0.93||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. placebo. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693266|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-0.68|||<|0.001|2-Sided|95.0|-0.99|-0.37||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693267|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-0.39|||<|0.014|2-Sided|95.0|-0.69|-0.08||Pairwise comparison, sitagliptin 50 mg + metformin 500 mg vs. metformin 500 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693268|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-0.84|||<|0.001|2-Sided|95.0|-1.15|-0.52||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. sitagliptin 100 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior AHA therapy status (yes/no) and a covariate for baseline A1C.|||
1693269|NCT01076088|3113989|Superiority or Other||Difference in Least Squares Mean|-0.27|||<|0.087|2-Sided|95.0|-0.58|0.04||Pairwise comparison, sitagliptin 50 mg + metformin 850 mg vs. metformin 850 mg. The normality assumption required for validity of ANCOVA was violated due to a biologically implausible extreme outlier. See below for results using robust regression.|ANCOVA|The ANCOVA model included terms for treatment and prior antihyperglycemic agent (AHA) therapy status (yes/no) and a covariate for baseline A1C.|||
1693270|NCT01076075|3113992|Superiority or Other||Difference in Least Squares Means|-18.6|||<|0.001|2-Sided|95.0|-26.4|-10.7|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, using the difference in the Least Squares Means.|
1693271|NCT01076075|3113993|Superiority or Other||Difference in Least Squares Means|-33.5|||<|0.001|2-Sided|95.0|-45.3|-21.7|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, difference in the Least Squares Means.|
1693272|NCT01076075|3113994|Superiority or Other||Difference in Least Squares Means|-0.68|||<|0.001|2-Sided|95.0|-0.87|-0.5|||ANCOVA|Based on an ANCOVA model controlling for treatment, stratum (type of sulfonylurea) and baseline value.||Pairwise comparison - Sitagliptin vs. Placebo, using the difference in the Least Squares Means.|
1693273|NCT01075971|3114013|Superiority or Other||Mean Difference (Final Values)|1.77|||<|0.0001|2-Sided|95.0|1.35|2.19||Analysis of variance with repeated measurements (daily scores from day 1 to day 5) for the whole set of patients was performed adjusted on the formulation (SL vs. FDT). Other independent factors were the subject and the day.|Analysis of variance||||
1693274|NCT01075815|3114028|Superiority or Other||Risk Ratio (RR)|0.9444||||0.8852|2-Sided|95.0|0.4347|2.0518|||Chi-squared||||
1693275|NCT01075815|3114030|Superiority or Other|||||||0.5952|||||||Wilcoxon two sample test||||
1693276|NCT01075815|3114031|Superiority or Other|||||||0.4164|||||||Wilcoxon two sample test||||
1693277|NCT01075815|3114032|Superiority or Other|||||||0.3267|||||||Wilcoxon two sample test||||
1693278|NCT01075815|3114033|Superiority or Other||Risk Ratio (RR)|0.875||||0.7271|2-Sided|95.0|0.4133|1.8524|||Chi-squared||||
1693279|NCT01075815|3114034|Superiority or Other||Risk Ratio (RR)|0.9625||||0.9179|2-Sided|95.0|0.4655|1.99|||Chi-squared||||
1693280|NCT01075815|3114036|Superiority or Other|||||||0.095|||||||Fisher Exact||||
1693281|NCT01075815|3114037|Superiority or Other|||||||0.4728|||||||ANOVA||||
1693282|NCT01075815|3114038|Superiority or Other|||||||0.0629|||||||Wilcoxon two sample test||||
1693283|NCT01075815|3114039|Superiority or Other|||||||0.3589|||||||ANOVA||||
1693284|NCT01075815|3114040|Superiority or Other||Mean Difference (Final Values)|0.0235||||0.8762|2-Sided|95.0|-0.1546|0.1568|||Wilcoxon two sample test||||
1693285|NCT01075763|3114041|Superiority or Other|||||||0.85|||||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.|
1693286|NCT01075763|3114041|Superiority or Other|||||||0.85|||||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.|
1693287|NCT01075763|3114041|Superiority or Other|||||||0.53|||||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.|
1693288|NCT01075763|3114042|Superiority or Other|||||||0.12|||||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.|
1693289|NCT01075763|3114042|Superiority or Other|||||||0.74|||||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.|
1693290|NCT01075763|3114042|Superiority or Other|||||||0.8|||||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.|
1693291|NCT01075763|3114044|Superiority or Other|||||||0.3|||||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.|
1693292|NCT01075763|3114044|Superiority or Other|||||||0.73|||||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.|
1693293|NCT01075763|3114044|Superiority or Other|||||||0.95|||||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.|
1693294|NCT01075763|3114045|Superiority or Other|||||||0.21|||||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.|
1693295|NCT01075763|3114045|Superiority or Other|||||||0.62|||||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.|
1693296|NCT01075763|3114045|Superiority or Other|||||||0.86|||||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.|
1693297|NCT01075763|3114046|Superiority or Other|||||||0.41|||||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.|
1693298|NCT01075763|3114046|Superiority or Other|||||||0.68|||||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.|
1693299|NCT01075763|3114046|Superiority or Other|||||||0.36|||||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.|
1693300|NCT01075763|3114046|Superiority or Other|||||||0.29|||||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.|
1693301|NCT01075763|3114047|Superiority or Other|||||||0.81|||||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.|
1693302|NCT01075763|3114047|Superiority or Other|||||||0.68|||||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.|
1693303|NCT01075763|3114047|Superiority or Other|||||||0.88|||||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.|
1693304|NCT01075763|3114047|Superiority or Other|||||||0.45|||||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.|
1693305|NCT01075763|3114048|Superiority or Other|||||||0.74|||||||t-test, 2 sided|||For Week 28: the difference between the two groups was analyzed using t-test.|
1693306|NCT01075763|3114048|Superiority or Other|||||||0.63|||||||t-test, 2 sided|||For Week 12: the difference between the two groups was analyzed using t-test.|
1693307|NCT01075763|3114049|Superiority or Other|||||||0.92|||||||t-test, 2 sided|||For Week 52: the difference between the two groups was analyzed using t-test.|
1693308|NCT01075763|3114049|Superiority or Other|||||||0.64|||||||t-test, 2 sided|||For baseline: the difference between the two groups was analyzed using t-test.|
1693309|NCT01075685|3114050|Superiority or Other|||||||0.082|||||||Chi-squared||||
1693310|NCT01075685|3114051|Superiority or Other|||||||0.009|||||||Chi-squared||||
1693311|NCT01075685|3114052|Superiority or Other|||||||0.0189|||||||Wilcoxon (Mann-Whitney)||||
1693313|NCT01075399|3114066|Superiority or Other||Pearson's Correlation Coefficient|0.945|||<|0.001|2-Sided|90.0|0.904|0.967||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor to background SUV ratio:~The reproducibility of [F-18]HX4 uptake in primary tumors was assessed by comparing tumor to background SUV ratio (T/B) of the 1st and 2nd [F18]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in T/B values, and for establishing reproducibility within ±20% or ±25%."|
1693314|NCT01075399|3114066|Superiority or Other||Pearson's Correlation Coefficient|0.887|||<|0.001|2-Sided|90.0|0.792|0.925||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor SUV mean:~The reproducibility of [F-18]HX4 uptake in primary tumors was assessed by comparing SUV mean of the 1st and 2nd [F18]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in SUV values, and for establishing reproducibility within ±20% or ±25%."|
1693315|NCT01075399|3114066|Superiority or Other||Pearson's Correlation Coefficient|0.883|||<|0.001|2-Sided|90.0|0.802|0.929||Significance of probability for no association between the first and second pre-treatment uptake.|Pearson's correlation|||"Primary Tumor SUV max:~The reproducibility of [F-18]HX4 uptake in primary tumors was assessed by comparing SUV max of the 1st and 2nd [F18]HX4 PET/CT scan.~Estimated power for a range of coefficients of variation (CVs) postulated for the paired differences in SUV values, and for establishing reproducibility within ±20% or ±25%."|
1693316|NCT01075282|3114093|Superiority or Other||LS Mean Difference|2.82|||<|0.001|2-Sided|95.0|2.17|3.46||Treatment comparison at 78 weeks.|ANCOVA||||
1693317|NCT01075282|3114093|Superiority or Other||LS Mean Difference|3.24|||<|0.001|2-Sided|95.0|2.59|3.89||Treatment comparison at 78 weeks.|ANCOVA||||
1693318|NCT01075282|3114093|Superiority or Other||LS Mean Difference|2.77|||<|0.001|2-Sided|95.0|2.17|3.36||Treatment comparison at 52 weeks.|ANCOVA||||
1693319|NCT01075282|3114093|Superiority or Other||LS Mean Difference|3.31|||<|0.001|2-Sided|95.0|2.71|3.9||Treatment comparison at 52 weeks.|ANCOVA||||
1693320|NCT01075282|3114093|Superiority or Other||LS Mean Difference|2.48|||<|0.001|2-Sided|95.0|1.99|2.99||Treatment comparison at 26 weeks.|ANCOVA||||
1693321|NCT01075282|3114093|Superiority or Other||LS Mean Difference|2.83|||<|0.001|2-Sided|95.0|2.33|3.33||Treatment comparison at 26 weeks.|ANCOVA||||
1693322|NCT01075282|3114096|Superiority or Other|||||||0.055||||||Treatment comparison at 78 weeks.|Mixed Models Analysis||||
1693323|NCT01075282|3114096|Superiority or Other|||||||0.641||||||Treatment comparison at 78 weeks.|Mixed Models Analysis||||
1693324|NCT01075282|3114096|Superiority or Other|||||||0.4||||||Treatment comparison at 52 weeks.|Mixed Models Analysis||||
1693325|NCT01075282|3114096|Superiority or Other|||||||0.091||||||Treatment comparison at 52 weeks.|Mixed Models Analysis||||
1693326|NCT01075282|3114096|Superiority or Other|||||||0.335||||||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1693327|NCT01075282|3114096|Superiority or Other|||||||0.109||||||Treatment comparison at 26 weeks.|Mixed Models Analysis||||
1693328|NCT01075282|3114097|Superiority or Other||Odds Ratio (OR)|1.53||||0.073|2-Sided|95.0|0.96|2.42||Treatment comparison at 78 weeks.|Regression, Logistic||||
1693329|NCT01075282|3114097|Superiority or Other||Odds Ratio (OR)|2.27|||<|0.001|2-Sided|95.0|1.44|3.57||Treatment comparison at 78 weeks.|Regression, Logistic|Treatment comparison at 78 weeks.|||
1693330|NCT01075282|3114097|Superiority or Other||Odds Ratio (OR)|2.07|||<|0.004|2-Sided|95.0|1.26|3.39||Treatment comparison at 52 weeks.|Regression, Logistic||||
1693331|NCT01075282|3114097|Superiority or Other||Odds Ratio (OR)|2.97|||<|0.001|2-Sided|95.0|1.81|4.85||Treatment comparison at 52 weeks.|Regression, Logistic||||
1693332|NCT01075282|3114097|Superiority or Other||Odds Ratio (OR)|2.54|||<|0.001|2-Sided|95.0|1.57|4.11||Treatment comparison at 26 weeks.|Regression, Logistic||||
1693333|NCT01075282|3114097|Superiority or Other||Odds Ratio (OR)|4.7|||<|0.001|2-Sided|95.0|2.9|7.63||Treatment comparison at 26 weeks.|Regression, Logistic||||
1693334|NCT01075282|3114098|Superiority or Other||Odds Ratio (OR)|1.22||||0.334|2-Sided|95.0|0.82|1.82||Treatment comparison at 78 weeks.|Regression, Logistic||||
1693335|NCT01075282|3114098|Superiority or Other||Odds Ratio (OR)|2.77|||<|0.001|2-Sided|95.0|1.85|4.14||Treatment comparison at 78 weeks.|Regression, Logistic||||
1693336|NCT01075282|3114098|Superiority or Other||Odds Ratio (OR)|1.42|||<|0.098|2-Sided|95.0|0.94|2.15||Treatment comparison at 52 weeks.|Regression, Logistic||||
1693337|NCT01075282|3114098|Superiority or Other||Odds Ratio (OR)|3.76|||<|0.001|2-Sided|95.0|2.45|5.75||Treatment comparison at 52 weeks.|Regression, Logistic||||
1693338|NCT01075282|3114098|Superiority or Other||Odds Ratio (OR)|2.13|||<|0.001|2-Sided|95.0|1.41|3.24||Treatment comparison at 26 weeks.|Regression, Logistic||||
1693339|NCT01075282|3114098|Superiority or Other||Odds Ratio (OR)|4.61|||<|0.001|2-Sided|95.0|2.98|7.11||Treatment comparison at 26 weeks.|Regression, Logistic||||
1693340|NCT01075282|3114099|Superiority or Other||LS Mean Difference|-0.03||||0.378|2-Sided|95.0|-0.21|0.15||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.|
1693341|NCT01075282|3114099|Superiority or Other||LS Mean Difference|-0.31|||<|0.001|2-Sided|95.0|-0.5|-0.13||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.|
1693342|NCT01075282|3114099|Non-Inferiority or Equivalence|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.03|||<|0.001|2-Sided|95.0|-0.21|0.15||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.|
1693446|NCT01074008|3114337|Superiority or Other|||||||0.013||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1696416|NCT01033942|3118857|Superiority or Other|||||||0.4668|||||||Fisher Exact||||
1693343|NCT01075282|3114099|Non-Inferiority or Equivalence|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.31|||<|0.001|2-Sided|95.0|-0.5|-0.13||Treatment comparison at 78 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.|
1693344|NCT01075282|3114099|Superiority or Other||LS Mean Difference|-0.24|||<|0.001|2-Sided|95.0|-0.38|-0.1||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.|
1693345|NCT01075282|3114099|Superiority or Other||LS Mean Difference|-0.51|||<|0.001|2-Sided|95.0|-0.65|-0.37||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.|
1693346|NCT01075282|3114099|Non-Inferiority or Equivalence|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.24|||<|0.001|2-Sided|95.0|-0.38|-0.1||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.|
1693347|NCT01075282|3114099|Non-Inferiority or Equivalence|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.51|||<|0.001|2-Sided|95.0|-0.65|-0.37||Treatment comparison at 26 weeks. P-value is adjusted for multiplicity, based on tree-gatekeeping strategy, and compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.|
1693348|NCT01075282|3114100|Superiority or Other||LS Mean Difference|-0.13||||0.05|2-Sided|95.0|-0.29|0.02||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.|
1693349|NCT01075282|3114100|Superiority or Other||LS Mean Difference|-0.45|||<|0.001|2-Sided|95.0|-0.6|-0.29||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.|
1693350|NCT01075282|3114100|Non-Inferiority or Equivalence|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.13|||<|0.001|2-Sided|95.0|-0.29|0.02||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.|
1693351|NCT01075282|3114100|Non-Inferiority or Equivalence|Family-wise Type I error rate was controlled by applying gatekeeping strategy.|LS Mean Difference|-0.45|||<|0.001|2-Sided|95.0|-0.6|-0.29||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||The study was designed with 90% power to detect non-inferiority of LY2189265 1.5 mg vs insulin glargine on HbA1c change from baseline at the 52-week primary endpoint with a margin of 0.4%, a standard deviation of 1.3%, and a 1-sided alpha of 0.025 assuming no true difference between treatments. This corresponds to 223 participants per arm, with an assumed drop-out rate of 20%.|
1693352|NCT01075256|3114101|Superiority or Other||Adjusted Mean Difference|-2.3||||0.6727|2-Sided|95.0|-13.42|8.73||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693353|NCT01075256|3114101|Superiority or Other||Adjusted Mean Difference|-1.7||||0.7575|2-Sided|95.0|-12.63|9.25||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693354|NCT01075256|3114101|Superiority or Other||Adjusted Mean Difference|0.7||||0.906|2-Sided|95.0|-10.38|11.68||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693355|NCT01075256|3114102|Superiority or Other||Adjusted Mean Difference|-1.2||||0.7976|2-Sided|95.0|-10.48|8.1||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693356|NCT01075256|3114102|Superiority or Other||Adjusted Mean Difference|-2.4||||0.601|2-Sided|95.0|-11.56|6.76||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693357|NCT01075256|3114102|Superiority or Other||Adjusted Mean Difference|-1.2||||0.7952|2-Sided|95.0|-10.51|8.09||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favours the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693447|NCT01074008|3114337|Superiority or Other|||||||0.013||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693358|NCT01075256|3114103|Superiority or Other||Adjusted Mean Difference|-3.3||||0.5998|2-Sided|95.0|-16.06|9.38||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693359|NCT01075256|3114103|Superiority or Other||Adjusted Mean Difference|0.0||||0.9944|2-Sided|95.0|-12.51|12.6||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693360|NCT01075256|3114103|Superiority or Other||Adjusted Mean Difference|3.4||||0.5946|2-Sided|95.0|-9.32|16.09||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693361|NCT01075256|3114104|Superiority or Other||Adjusted Mean Difference|-1.0||||0.8231|2-Sided|95.0|-9.73|7.77||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693362|NCT01075256|3114104|Superiority or Other||Adjusted Mean Difference|-0.5||||0.9083|2-Sided|95.0|-9.13|8.14||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level|
1693363|NCT01075256|3114104|Superiority or Other||Adjusted Mean Difference|0.5||||0.9124|2-Sided|95.0|-8.28|9.24||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693364|NCT01075256|3114105|Superiority or Other||Adjusted Mean Difference|1.0||||0.76|2-Sided|95.0|-5.36|7.33||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693365|NCT01075256|3114105|Superiority or Other||Adjusted Mean Difference|0.3||||0.9147|2-Sided|95.0|-6.03|6.72||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693366|NCT01075256|3114105|Superiority or Other||Adjusted Mean Difference|-0.6||||0.8419|2-Sided|95.0|-6.93|5.66||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693367|NCT01075256|3114106|Superiority or Other||Adjusted mean difference|-0.6||||0.8662|2-Sided|95.0|-7.04|5.93||No adjustments for multiple comparisons|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|
1693368|NCT01075256|3114106|Superiority or Other||Adjusted Mean Difference|-0.5||||0.8903|2-Sided|95.0|-6.97|6.06||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693369|NCT01075256|3114106|Superiority or Other||Adjusted Mean Difference|0.1||||0.9759|2-Sided|95.0|-6.34|6.54||No adjustments for multiple comparisons|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693370|NCT01075256|3114107|Superiority or Other||Adjusted Mean Difference|1.1||||0.6599|2-Sided|95.0|-3.69|5.81||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693371|NCT01075256|3114107|Superiority or Other||Adjusted Mean Difference|0.0||||0.9888|2-Sided|95.0|-4.74|4.81||No adjustments for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is the high concentration minus placebo such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693599|NCT01072149|3114580|Superiority or Other||Mean Difference (Final Values)|0.236|||<|0.001|2-Sided|95.0|0.181|0.291|||Mixed Models Analysis||||
1693372|NCT01075256|3114107|Superiority or Other||Adjusted Mean Difference|-1.0||||0.6674|2-Sided|95.0|-5.73|3.68||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693373|NCT01075256|3114108|Superiority or Other||Adjusted Mean difference|2.3||||0.3257|2-Sided|95.0|-2.31|6.92||No adustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693374|NCT01075256|3114108|Superiority or Other||Adjusted Mean Difference|0.2||||0.9361|2-Sided|95.0|-4.45|4.83||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity.|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no difference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693375|NCT01075256|3114108|Superiority or Other||Adjusted Mean Difference|-2.1||||0.3628|2-Sided|95.0|-6.7|2.46||No adjustment was made for multiple comparisons.|ANCOVA|ANCOVA model adjusted for baseline, treatment and number of sensitive teeth and years of sensitivity|Difference was first named treatment minus second named treatment such that a positive difference favors the first named treatment.|The null hypothesis was no diference between treatments in comparison. Statistical tests were 2-sided at 5% significance level.|
1693376|NCT01075243|3114123|Superiority or Other||Adjusted Mean Difference|7.63|||<|0.0001||95.0|4.94|10.31|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID^6h between Paracetamol 650 mg caplet and placebo caplet.|
1693377|NCT01075243|3114123|Superiority or Other||Adjusted Mean DIfference|11.33|||<|0.0001|2-Sided|95.0|8.66|14.0|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID^6h between Paracetamol 1000 mg caplet and placebo caplet.|
1693378|NCT01075243|3114123|Superiority or Other||Adjusted Mean Difference|3.71|||<|0.0009|2-Sided|95.0|1.53|5.89|||ANCOVA|ANCOVA model included factors for treatment as a fixed effect and baseline assessment of pain intensity (VAS score) as a covariate.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered no difference in SPRID^6h between Paracetamol 1000 mg caplet and Paracetamol 650 mg caplet.|
1693379|NCT01075217|3114127|Superiority or Other||Mean Difference (Final Values)|1.6|Standard Deviation|2.35||0.0059|2-Sided|95.0|0.5|2.7|||t-test, 2 sided||||
1693380|NCT01075217|3114128|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Deviation|1.94||0.3244|2-Sided|95.0|-0.5|1.4||P-value provided is for the difference in pain assessment between Isovue and Visipaque in Group 2, i.e., pain was assessed separately from heat.|t-test, 2 sided||||
1693381|NCT01075217|3114128|Superiority or Other||Mean Difference (Final Values)|2.5|Standard Deviation|2.45|<|0.0001|2-Sided|95.0|1.4|3.5||P-value provided is for the difference in pain assessment between Isovue and Visipaque in Group 1, i.e., pain was not assessed separately from heat.|t-test, 2 sided||||
1693382|NCT01075204|3114140|Superiority or Other|||||||0.334|||||||Chi-squared|9 degrees of freedom.||Logistic regression: Omnibus Test of Model Coefficients (all the nine variables are considered together).|
1693383|NCT01075178|3114149|Non-Inferiority or Equivalence|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.9|||||1-Sided|95.0||2.19|||||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.|
1693384|NCT01075178|3114150|Non-Inferiority or Equivalence|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|1.05|||||1-Sided|95.0||1.64|||||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.|
1693385|NCT01075178|3114151|Non-Inferiority or Equivalence|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.8|||||1-Sided|95.0||0.95|||||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.|
1693448|NCT01074008|3114337|Superiority or Other|||||||0.37||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693386|NCT01075178|3114152|Non-Inferiority or Equivalence|Non-inferiority was assessed with a 95% 1-sided confidence interval for which the upper bound of the difference in the event rates (CASES minus CONTROLS) will correspond to an odds ratio less than 2 (that is, the odds ratio calculated at the upper confidence bound of the difference in event rates will be less than 2).|Observed odds ratio|0.81|||||1-Sided|95.0||0.96|||||"Result provided for 95% Confidence Interval (1-Sided) is the odds ratio calculated at the upper bound of the 1-sided 95% confidence interval for the difference in event rates (CASES minus CONTROLS)."|The null hypothesis was that the odds ratio was greater than or equal to 2. The planned sample size of 2000 participants (1000 participants in each group) provided greater than 90% power to determine non-inferiority based on the odds ratio less than 2.|
1693387|NCT01075152|3114153|Superiority or Other (legacy)|||||||0.02||||||This is the interaction p-value for CSF white cell count at randomization (implying there is a statistical difference in the outcome by arm based on this parameter).|Regression, Cox|||Pre-specified subgroups formed by baseline characteristics were compared for 26 week survival with models including an interaction term between treatment arm and subgroup.|
1693388|NCT01075152|3114154|Superiority or Other (legacy)|||||||0.44|||||||Regression, Linear|a linear mixed effects regression model fit with a random intercept and slope estimated the rate of clearance||To describe early fungicidal activity, a linear mixed effects regression model fit with a random intercept and slope estimated the rate of clearance of log10 colony forming units (CFU) of Cryptococcus, per mL of CSF per day, for all participants with >2 cultures obtained.|
1693389|NCT01075152|3114155|Superiority or Other (legacy)|||||||0.34|||||||repeated measure analysis|||The overall change from baseline in Karnofsky performance status scores was compared between groups via a repeated measure analysis, unstructured covariance matrix, adjusted for baseline value.|
1693390|NCT01075152|3114156|Superiority or Other (legacy)|||||||0.23|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher’s exact tests.|
1693391|NCT01075152|3114157|Superiority or Other (legacy)|||||||0.26|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher’s exact tests.|
1693392|NCT01075152|3114158|Superiority or Other (legacy)||Hazard Ratio (HR)|1.66||||0.04|2-Sided|95.0|1.03|2.68|||Regression, Cox|||We compared the randomization arms for survival using time-to-event methods of Cox proportional hazards models.|
1693393|NCT01075152|3114159|Superiority or Other (legacy)|||||||0.98|||||||Fisher Exact|||Categorical secondary endpoints were compared with Fisher’s exact tests.|
1693394|NCT01075152|3114160|Superiority or Other (legacy)|||||||0.06|||||||Gray's method of cumulative incidence|||To account for the competing risk of death, the cumulative incidence function compared the randomized groups for endpoints of IRIS, relapse, and adverse events (Gray's method).|
1693395|NCT01075152|3114161|Superiority or Other (legacy)|||||||0.32|||||||Gray's method of cumulative incidence|||To account for the competing risk of death, the cumulative incidence function compared the randomized groups for endpoints of IRIS, relapse, and adverse events (Gray's method).|
1693396|NCT01075152|3114162|Superiority or Other (legacy)||Hazard Ratio (HR)|1.73||||0.03|2-Sided|95.0|1.06|2.82||A Lan-DeMets spending function analog of the O’Brien-Fleming boundaries was proposed to control the type-I error resulting from multiple interim analyses.|Regression, Cox||Hazard Ratio describes the risk of earlier HIV therapy in comparison to deferred HIV therapy initiation as the reference group.|"We compared the randomization arms for the primary endpoint of survival using time-to-event methods of Cox proportional hazards models by the intention-to-treat principle, based on two-sided type-I error with alpha=0.05.~The trial was statistically powered to detect a 25% relative survival benefit (15% absolute benefit) with 90% power and overall two-sided alpha=0.05 with an intended sample size of 500 participants. The trial was halted early by the Data and Safety Monitoring Board."|
1693397|NCT01075087|3114170|Superiority or Other||Median Difference (Net)|-5.5||||0.05|2-Sided|90.0|-26.0|3.0|||Wilcoxon (Mann-Whitney)||||
1693398|NCT01075074|3114171|Superiority or Other||Median Difference (Net)|0.0||||0.92|2-Sided|95.0|-30.0|30.0|||Wilcoxon (Mann-Whitney)||||
1693399|NCT01075074|3114171|Superiority or Other||Median Difference (Net)|30.0||||0.04|2-Sided|95.0|0.0|60.0|||Wilcoxon (Mann-Whitney)||||
1693400|NCT01075074|3114171|Superiority or Other||Median Difference (Net)|30.0||||0.01|2-Sided|95.0|0.0|60.0|||Wilcoxon (Mann-Whitney)||||
1693401|NCT01075074|3114171|Superiority or Other|||||||0.03||||||Corrected for multiple comparisons (n=6).|Kruskal-Wallis||||
1693402|NCT01075074|3114172|Superiority or Other||Median Difference (Net)|1.0||||0.95|2-Sided|95.0|-18.0|20.0|||Wilcoxon (Mann-Whitney)||||
1693403|NCT01075074|3114172|Superiority or Other||Median Difference (Net)|40.0||||0.003|2-Sided|95.0|12.0|47.0|||Wilcoxon (Mann-Whitney)||||
1693404|NCT01075074|3114172|Superiority or Other||Median Difference (Net)|38.0||||0.01|2-Sided|95.0|8.0|50.0|||Wilcoxon (Mann-Whitney)||||
1693405|NCT01075074|3114172|Superiority or Other|||||||0.0005||||||Corrected for multiple comparisons (n=6).|Kruskal-Wallis||||
1693406|NCT01075074|3114173|Superiority or Other||Median Difference (Net)|0.0||||0.86|2-Sided|95.0|-105.0|83.0|||Wilcoxon (Mann-Whitney)||||
1693407|NCT01075074|3114173|Superiority or Other||Median Difference (Net)|195.0||||0.0003|2-Sided|95.0|98.0|278.0|||Wilcoxon (Mann-Whitney)||||
1693408|NCT01075074|3114173|Superiority or Other||Median Difference (Net)|195.0||||0.0004|2-Sided|95.0|98.0|300.0|||Wilcoxon (Mann-Whitney)||||
1693409|NCT01075074|3114173|Superiority or Other|||||||0.0003||||||Corrected for 6 comparisons|Kruskal-Wallis||||
1693410|NCT01075074|3114173|Superiority or Other|||||||0.0003||||||P values is corrected for 6 comparisons|Kruskal-Wallis||||
1693411|NCT01075074|3114174|Superiority or Other||Median Difference (Net)|1.0||||1|2-Sided|95.0|-16.0|12.0|||Wilcoxon (Mann-Whitney)||||
1693412|NCT01075074|3114174|Superiority or Other||Median Difference (Net)|17.0||||0.01|2-Sided|95.0|2.0|31.0|||Wilcoxon (Mann-Whitney)||||
1693413|NCT01075074|3114174|Superiority or Other||Median Difference (Net)|16.0||||0.03|2-Sided|95.0|1.0|30.0|||Wilcoxon (Mann-Whitney)||||
1693414|NCT01075074|3114174|Superiority or Other|||||||0.006||||||Corrected for 6 comparisons.|Kruskal-Wallis|||A sample size of 23 subjects per group was estimated to achieve 80% power to detect a 10 point difference in the aggregated QOR40 score for the 3 study groups to be compared assuming an overall standard deviation of 12.|
1693600|NCT01072149|3114580|Superiority or Other||Mean Difference (Final Values)|0.22|||<|0.001|2-Sided|95.0|0.165|0.275|||Mixed Models Analysis||||
1693415|NCT01074944|3114210|Non-Inferiority or Equivalence|Eliglustat QD treatment was declared non-inferior to BID treatment if the lower bound of the 95% confidence interval (CI) for the difference was within the non-inferiority margin of -0.15 (or -15%).|Difference in Percentage Stable|-2.7|||||2-Sided|95.0|-17.7|11.9|||||||
1693416|NCT01074463|3114229|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|102.34|||||2-Sided|90.0|97.78|107.11|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1693417|NCT01074463|3114230|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|104.06|||||2-Sided|90.0|98.73|109.68|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1693418|NCT01074463|3114231|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|109.18|||||2-Sided|90.0|99.25|120.12|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1693419|NCT01074450|3114232|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|104.15|||||2-Sided|90.0|99.05|109.52|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1693420|NCT01074450|3114233|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|104.71|||||2-Sided|90.0|99.74|109.92|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1693421|NCT01074450|3114234|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.93|||||2-Sided|90.0|94.23|108.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1693422|NCT01074229|3114262|Superiority or Other||Mean Difference (Net)|5.0||||0.14|2-Sided|95.0|-1.0|12.0|||Dunns test||||
1693423|NCT01074229|3114262|Superiority or Other||Median Difference (Net)|10.0||||0.003|2-Sided|95.0|3.0|15.0|||Dunns test||||
1693424|NCT01074229|3114262|Superiority or Other|||||||0.05|||||||Kruskal-Wallis|With Dunns test and Bonferonni correction.|||
1693425|NCT01074229|3114263|Superiority or Other||Mean Difference (Net)|28.0||||0.05|2-Sided|95.0|14.0|42.0|||Dunns Test|Bonferroni correction|||
1693426|NCT01074229|3114263|Superiority or Other||Median Difference (Final Values)|28.0||||0.05|2-Sided|95.0|9.0|37.0|||Dunns test|Bonferonni correction|||
1693427|NCT01074229|3114263|Superiority or Other|||||||0.05|||||||Kruskal-Wallis|Using Dunns test with Bonferroni conrrection for individual comparisons.|||
1693428|NCT01074125|3114278|Superiority or Other||Mean Difference (Final Values)|-0.3376|||<|0.0001|2-Sided||||||Regression, Linear|||To assess dose ranging, the primary efficacy variable will be analyzed via a model with dose effect. Positive dose ranging confirmed if the null hypothesis of slope =0 was rejected at a significance level of 0.05|
1693429|NCT01074047|3114283|Superiority or Other||Relative Ratio|0.79||||0.0721|2-Sided|95.0|0.62|1.02|||negative binomial regression analysis||||
1693430|NCT01074047|3114307|Superiority or Other|||||||0.0376|||||||Fisher Exact|P-value is from Fishers exact test|||
1693431|NCT01074047|3114309|Superiority or Other|||||||0.5384|||||||Fisher Exact|P-value is from Fishers exact test|||
1693432|NCT01074047|3114310|Superiority or Other||Hazard Ratio (HR)|1.11||||0.5832|2-Sided|95.0|0.75|1.66|||Log Rank|2 sided unstratified|The hazard ratio is from an unstratified Cox proportional hazards model.|Median is estimated from a Kaplan-Meier distribution of RFS|
1693433|NCT01074047|3114311|Superiority or Other||Hazard Ratio (HR)|0.87||||0.1495|2-Sided|95.0|0.72|1.05|||Log Rank|2 sided unstratified|The hazard ratio is from an unstratified Cox proportional hazards model.|Median is estimated from a Kaplan-Meier distribution of EFS|
1693434|NCT01074047|3114312|Superiority or Other||Difference|12.26|||||2-Sided|95.0|3.5|21.0|||||Estimates of the 1-year (365 day) survival probabilities and corresponding 95% confidence intervals (CI) were presented by treatment group. The CI for the difference in the 1-year survival probabilities was derived using Greenwoods variance estimate.||
1693435|NCT01074047|3114313|Superiority||Hazard Ratio (HR)|0.85||||0.1009|2-Sided|95.0|0.69|1.03|||Log Rank||The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.||
1693436|NCT01074047|3114313|Superiority or Other||Hazard Ratio (HR)|0.84||||0.0829|2-Sided|95.0|0.69|1.02|||Log Rank|The p-value is two-sided from an unstratified log-rank test|The hazard ratio is from a Cox proportional hazards model stratified by ECOG performance status and cytogenetic risk status.||
1693437|NCT01074008|3114324|Superiority or Other|||||||0.074||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693438|NCT01074008|3114324|Superiority or Other|||||||0.005||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693439|NCT01074008|3114324|Superiority or Other|||||||0.013||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693440|NCT01074008|3114324|Superiority or Other|||||||0.319||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693441|NCT01074008|3114324|Superiority or Other|||||||0.024||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693449|NCT01074008|3114337|Superiority or Other|||||||0.013||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693450|NCT01074008|3114337|Superiority or Other|||||||0.013||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693451|NCT01074008|3114337|Superiority or Other|||||||0.059||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693452|NCT01074008|3114337|Superiority or Other|||||||0.013||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693453|NCT01074008|3114338|Superiority or Other|||||||0.111||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693454|NCT01074008|3114338|Superiority or Other|||||||0.111||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693455|NCT01074008|3114338|Superiority or Other|||||||0.245||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693456|NCT01074008|3114338|Superiority or Other|||||||1||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693457|NCT01074008|3114338|Superiority or Other|||||||0.262||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693458|NCT01074008|3114338|Superiority or Other||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693459|NCT01074008|3114338|Superiority or Other||||||<|0.006||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693460|NCT01074008|3114338|Superiority or Other||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|Fisher Exact||||
1693461|NCT01074008|3114339|Superiority or Other|||||||0.053||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-333 group and 11 participants in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.|
1693462|NCT01074008|3114339|Superiority or Other|||||||0.032||||||There was no adjustment for multiple comparisons and the pre-specified, 2-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight subjects per ABT-333 group and 11 subjects in the placebo group would provide 82% power to detect a 1.0 log10 IU/mL difference with a standard deviation of 0.7 log10 IU/mL and a 2-sided 2-sample t-test with a significance level of 0.05.|
1693463|NCT01074008|3114339|Superiority or Other||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.|
1693464|NCT01074008|3114339|Superiority or Other||||||<|0.012||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.|
1693465|NCT01074008|3114339|Superiority or Other||||||<|0.009||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-072 and 11 participants in the placebo group would provide 92% power to detect a 1.0 log10 difference with a standard deviation of 0.6 log10 IU/mL and a two-sided, two-sample t-test with a significance level of 0.05.|
1693466|NCT01074008|3114339|Superiority or Other||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide > 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.|
1693467|NCT01074008|3114339|Superiority or Other||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide > 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.|
1693468|NCT01074008|3114339|Superiority or Other||||||<|0.001||||||There was no adjustment for multiple comparisons and the pre-specified, two-sided significance level was ≤ 0.05.|ANCOVA|Treatment was the factor and baseline log10 HCV RNA level was the covariate.||Eight participants per ABT-450/r group and 11 participants in the placebo group would provide > 95% power to detect a 1.0 log10 difference with a common standard deviation of 0.5 log10 IU/mL using a two-sided, two-sample t-test with a significance level of 0.05.|
1693469|NCT01073943|3114340|Non-Inferiority or Equivalence|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|0.9|||||1-Sided|97.5|-5.7|||||||Overall comparison: ascending colon, mid colon and recto-sigmoid colon|
1693497|NCT01073605|3114368|Superiority or Other||Mean Difference (Final Values)|0.05||||0.8971|2-Sided|95.0|-0.65|0.74||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.|||
1693470|NCT01073943|3114340|Non-Inferiority or Equivalence|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|3.2|||||1-Sided|97.5|-1.5|||||||Recto-sigmoid colon comparison|
1693471|NCT01073943|3114340|Non-Inferiority or Equivalence|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|4.5|||||1-Sided|97.5|-0.1|||||||Mid colon comparison|
1693472|NCT01073943|3114342|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1693473|NCT01073943|3114343|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1693474|NCT01073943|3114344|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1693475|NCT01073943|3114345|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1693476|NCT01073943|3114346|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1693477|NCT01073943|3114347|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1693478|NCT01073943|3114348|Non-Inferiority or Equivalence|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|-2.7|||||1-Sided|97.5|-8.8||||||||
1693479|NCT01073943|3114349|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was >-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was >0%.|Mean Difference (Net)|3.3|||||1-Sided|97.5|-2.9||||||||
1693480|NCT01073930|3114351|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1693481|NCT01073930|3114352|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1693482|NCT01073930|3114353|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1693483|NCT01073930|3114354|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1693484|NCT01073930|3114355|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1693485|NCT01073930|3114356|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1693486|NCT01073930|3114357|Non-Inferiority or Equivalence|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|11.4|||||1-Sided|97.5|5.2|||||||Overall: Ascending, mid, and recto-sigmoid colon comparison|
1693487|NCT01073930|3114357|Non-Inferiority or Equivalence|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|5.2|||||1-Sided|97.5|0.4|||||||Recto-sigmoid colon comparison|
1693488|NCT01073930|3114357|Non-Inferiority or Equivalence|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|6.6|||||1-Sided|97.5|1.6|||||||Mid colon comparison|
1693489|NCT01073930|3114357|Non-Inferiority or Equivalence|If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared.|Mean Difference (Net)|10.7|||||1-Sided|97.5|4.9|||||||Ascending colon comparison|
1693490|NCT01073930|3114358|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was >-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was >0%.|Mean Difference (Net)|9.8|||||1-Sided|97.5|3.4||||||||
1693491|NCT01073865|3114360|Superiority or Other||Risk Difference (RD)|-3.02|||||2-Sided|95.0|-15.47|9.67|||||ORR at 24 weeks for Zoladex 10.8mg - ORR at 24 weeks for Zoladex 3.6mg|CI for the difference (10.8 mg-3.6 mg) in ORR at 24 weeks calculated using the score method recommended by Newcombe et al|
1693492|NCT01073865|3114361|Non-Inferiority or Equivalence|The lower limit of the CI of the difference is greater than or equal to –17.5%. This non-inferiority margin was pre-defined in the study protocol.|Risk Difference (RD)|1.29|||||2-Sided|95.0|-11.4|13.9|||||%PFS at 24 weeks for Zoladex 10.8mg - %PFS at 24 weeks for Zoladex 3.6mg|CI for the difference (10.8 mg-3.6 mg) in %PFS at 24 weeks calculated using the score method recommended by Newcombe et al|
1693493|NCT01073657|3114362|Superiority or Other||Mean Difference (Net)|18.0|Standard Deviation|33.9||0.0059|2-Sided|95.0|14.0|38.0|||t-test, 2 sided||||
1693494|NCT01073631|3114364|Superiority or Other||Efficacy rate (percent)|78.9|||||2-Sided|95.0|75.07|82.73|||||Confidence Interval (CI) by normal approximation to binomial.|Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement|
1693495|NCT01073618|3114366|Superiority or Other||Efficacy rate (percent)|75.15|||||2-Sided|95.0|71.36|78.94|||||Confidence Interval (CI) by normal approximation to binomial.|Efficacy Rate (treatment effective) = Percentage of evaluable participants with clinical response of cure or improvement|
1693496|NCT01073605|3114368|Superiority or Other||Mean Difference (Final Values)|-0.63||||0.0583|2-Sided|95.0|-1.27|0.02||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.|||
1693498|NCT01073605|3114368|Superiority or Other||Mean Difference (Final Values)|0.67||||0.0681|2-Sided|95.0|-0.05|1.39||There is no adjustment for multiplicity of treatment comparisons.|ANCOVA|The Analysis of Covariance took into account the patient covariates age and gender.|||
1693499|NCT01073605|3114373|Superiority or Other||||||<|0.0001||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years|
1693500|NCT01073605|3114373|Superiority or Other||||||<|0.58324||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years|
1693501|NCT01073605|3114373|Superiority or Other||||||<|0.0001||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years|
1693502|NCT01073605|3114377|Superiority or Other|||||||0.16421||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years|
1693503|NCT01073605|3114377|Superiority or Other|||||||0.63956||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years|
1693504|NCT01073605|3114377|Superiority or Other|||||||0.57556||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||3 years|
1693505|NCT01073605|3114377|Superiority or Other|||||||0.0053||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years|
1693506|NCT01073605|3114377|Superiority or Other|||||||0.68581||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years|
1693507|NCT01073605|3114377|Superiority or Other|||||||0.03273||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||2 years|
1693508|NCT01073605|3114377|Superiority or Other|||||||8e-05||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year|
1693509|NCT01073605|3114377|Superiority or Other|||||||0.25995||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year|
1693510|NCT01073605|3114377|Superiority or Other|||||||0.00125||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)|||1 year|
1693511|NCT01073605|3114379|Superiority or Other|||||||0.00467||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)||||
1693512|NCT01073605|3114379|Superiority or Other|||||||0.74299||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)||||
1693513|NCT01073605|3114379|Superiority or Other|||||||0.02922||||||P-values for the 3 treatment comparisons should be interpreted in line with the Bonferroni stepwise (Holm) testing procedure, to maintain the Type 1 error at p=0.05.|Wilcoxon (Mann-Whitney)||||
1693514|NCT01073566|3114381|Superiority or Other||||||<|0.001|||||||McNemar|||Higher number is better. The answers were scored on a scale of 0-100 to standardize as described in the original papers.|
1693515|NCT01073566|3114382|Superiority or Other||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.15||0.004|2-Sided|95.0|-0.8|-0.17|||ANOVA||Finesse versus usual injection device|This was conducted at a 2-sided alpha level of 0.05 and confidence intervals (CI) were calculated at 95%, 2-sided. A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.|
1693516|NCT01073566|3114383|Non-Inferiority or Equivalence|Pre-study power calculations determined that 28 completed subjects provided 90% power to detect equivalence for the primary endpoint of MDBG of bolus-patch compared to pen/syringe using a 2-sided alpha level of 0.05, when the margin of equivalence for MDBG is 1.11 mmol/L, the true mean difference is 0.0, and the standard deviation of the differences is 1.72 mmol/L.|Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.24||0.098|2-Sided|95.0|-0.97|0.16|||ANOVA||Finesse versus usual injection device.|A two-period, two-treatment crossover ANOVA model was used to compare devices for continuous measures.|
1693517|NCT01073293|3114396|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|0.0|||<|0.001|2-Sided|95.0|-0.8|0.8|||Miettinen and Nurminen|||Poliovirus type 3|
1693518|NCT01073293|3114396|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|-0.2|||<|0.001|2-Sided|95.0|-1.2|0.8|||Miettinen and Nurminen|||Poliovirus type 2|
1693519|NCT01073293|3114396|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points|Difference in percentage|-0.2|||<|0.001|2-Sided|95.0|-1.2|0.8|||Miettinen and Nurminen|||Poliovirus type 1|
1693520|NCT01073293|3114397|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.67|Difference in GMT|0.89||||0.005|2-Sided|95.0|0.72|1.11|||ANOVA|||Anti-FIM 2/3|
1693521|NCT01073293|3114397|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.67|Difference in GMT|0.94|||<|0.001|2-Sided|95.0|0.8|1.09|||ANOVA|||Anti-PRN|
1693601|NCT01072149|3114580|Superiority or Other||Median Difference (Final Values)|0.233|||<|0.001|2-Sided|95.0|0.179|0.287|||Mixed Models Analysis||||
1693522|NCT01073293|3114397|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.67|Fold difference in GMT|0.99|||<|0.001|2-Sided|95.0|0.9|1.08|||ANOVA|||Anti-FHA|
1693523|NCT01073293|3114397|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.67|Fold difference in GMT|0.95|||<|0.001|2-Sided|95.0|0.85|1.06|||ANOVA|||Anti-PT|
1693524|NCT01073293|3114398|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.0|||<|0.001|2-Sided|95.0|-1.1|1.2|||Miettinen and Nurminen|||Anti-tetanus titer >=0.1 IU/mL|
1693525|NCT01073293|3114398|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.2|||<|0.001|2-Sided|95.0|-0.7|1.4|||Miettinen and Nurminen|||Anti-diphtheria titer >=0.1 IU/mL|
1693526|NCT01073293|3114403|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.89|||<|0.001|2-Sided|95.0|0.8|0.99|||ANOVA|||Anti-HPV 58|
1693527|NCT01073293|3114403|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.95|||<|0.001|2-Sided|95.0|0.85|1.06|||ANOVA|||Anti-HPV 52|
1693528|NCT01073293|3114403|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.97|||<|0.001|2-Sided|95.0|0.86|1.11|||ANOVA|||Anti-HPV 45|
1693529|NCT01073293|3114403|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.9|||<|0.001|2-Sided|95.0|0.81|1.0|||ANOVA|||Anti-HPV 33|
1693530|NCT01073293|3114403|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.94|||<|0.001|2-Sided|95.0|0.84|1.06|||ANOVA|||Anti-HPV 31|
1693531|NCT01073293|3114403|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.95|||<|0.001|2-Sided|95.0|0.84|1.07|||ANOVA|||Anti-HPV 18|
1693532|NCT01073293|3114403|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.94|||<|0.001|2-Sided|95.0|0.85|1.04|||ANOVA|||Anti-HPV 16|
1693533|NCT01073293|3114403|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.97|||<|0.001|2-Sided|95.0|0.87|1.07|||ANOVA|||Anti-HPV 11|
1693534|NCT01073293|3114403|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.95|||<|0.001|2-Sided|95.0|0.86|1.05|||ANOVA|||Anti-HPV 6|
1693535|NCT01072929|3114440|Superiority or Other||Mean Difference (Final Values)|-2.9||||0.0385|2-Sided|95.0|-5.71|-0.16||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.|||
1693536|NCT01072929|3114440|Superiority or Other||Mean Difference (Final Values)|-3.8||||0.0097|2-Sided|95.0|-6.58|-0.92||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.|||
1693537|NCT01072877|3114441|Superiority or Other||Mean Difference (Final Values)|-0.9|||<|0.0001|2-Sided|95.0|-1.11|-0.68|||ANCOVA||||
1693538|NCT01072877|3114441|Superiority or Other||Mean Difference (Final Values)|-0.75|||<|0.0001|2-Sided|95.0|-0.97|-0.53|||ANCOVA||||
1693539|NCT01072877|3114441|Superiority or Other||Mean Difference (Final Values)|-0.76|||<|0.0001|2-Sided|95.0|-0.98|-0.53|||ANCOVA||||
1693540|NCT01072877|3114441|Superiority or Other||Mean Difference (Final Values)|-0.45|||=|0|2-Sided|95.0|-0.66|-0.23|||ANCOVA||||
1693541|NCT01072877|3114442|Superiority or Other||Mean Difference (Final Values)|-1.6|||<|0.0001|2-Sided|95.0|-1.98|-1.23|||ANCOVA||||
1693542|NCT01072877|3114442|Superiority or Other||Mean Difference (Final Values)|-1.45|||<|0.0001|2-Sided|95.0|-1.85|-1.06|||ANCOVA||||
1693543|NCT01072877|3114442|Superiority or Other||Mean Difference (Final Values)|-1.26|||<|0.0001|2-Sided|95.0|-1.65|-0.86|||ANCOVA||||
1693544|NCT01072877|3114442|Superiority or Other||Mean Difference (Final Values)|-0.78|||=|0|2-Sided|95.0|-1.17|-0.4|||ANCOVA||||
1693545|NCT01072877|3114443|Superiority or Other||Mean Difference (Final Values)|-3.65|||<|0.0001|2-Sided|95.0|-4.84|-2.46|||ANCOVA||||
1693546|NCT01072877|3114443|Superiority or Other||Mean Difference (Final Values)|-2.73|||<|0.0001|2-Sided|95.0|-3.98|-1.48|||ANCOVA||||
1693547|NCT01072877|3114443|Superiority or Other||Mean Difference (Final Values)|-3.54|||<|0.0001|2-Sided|95.0|-4.8|-2.29|||ANCOVA||||
1693548|NCT01072877|3114443|Superiority or Other||Mean Difference (Final Values)|-2.49|||=|0|2-Sided|95.0|-3.72|-1.27|||ANCOVA||||
1693549|NCT01072630|3114482|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.135|2-Sided|95.0|-4.51|0.61||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.|||
1693804|NCT01068743|3114996|Superiority or Other||Geometric Least Squares Mean (ng/mL|1724.4||||||||||||||Geometric least squares means for Treatment A.|
1693550|NCT01072630|3114482|Superiority or Other||Mean Difference (Final Values)|-2.1||||0.1302|2-Sided|95.0|-4.67|0.6||All statistical tests were 2-tailed at the 0.05 level of significance.|mixed-model repeated measures (MMRM)|Treatment, visit, treatment-by-visit interaction, concurrent mood-stabilizing medication, and region of the world used as fixed factors.|||
1693551|NCT01072539|3114488|Superiority or Other||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Concomitant Medications: Yes VS Concomitant Medications: No|
1693552|NCT01072539|3114488|Superiority or Other||||||<|0.0376||||||Statistical significant level: 0.05|Chi-squared|||Past Medication and Therapy: Yes VS Past Medication and Therapy: No|
1693553|NCT01072539|3114488|Superiority or Other||||||<|0.0001||||||Statistical significant level 0.05|Fisher Exact|||Comparison among subgroups of Mean Daily Dose of Tygacil: <50 mg, 50 to <100 mg, 100 to <200 mg, and >=200 mg.|
1693554|NCT01072539|3114488|Superiority or Other||||||<|0.0153||||||Statistical significant level: 0.05|Chi-squared|||Comparison among subgroups of Total Treatment Period of Tygacil: <7 Days, 7 to 14 Days, and >14 Days|
1693555|NCT01072539|3114488|Superiority or Other||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Liver Disorder: Yes VS Liver Disorder: No|
1693556|NCT01072539|3114488|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Kidney Disorder: Yes VS Kidney Disorder: No|
1693557|NCT01072539|3114488|Superiority or Other||||||<|0.0006||||||Statistical significant level: 0.05|Chi-squared|||General Medical History (Past): Yes VS General Medical History (Past): No|
1693558|NCT01072539|3114488|Superiority or Other||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||General Medical History (Present): Yes VS General Medical History (Present): No|
1693559|NCT01072539|3114488|Superiority or Other||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||General Medical History: Yes VS General Medical History: No|
1693560|NCT01072539|3114488|Superiority or Other||||||<|0.0001||||||Satistical significant level: 0.05|Chi-squared|||Comparison among severity of infection subgroups: Mild, Moderate, and Severe.|
1693561|NCT01072539|3114488|Superiority or Other||||||<|0.0064||||||Statistical significant level: 0.05|Fisher Exact|||Comparison among subgroups of infection site: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.|
1693562|NCT01072539|3114488|Superiority or Other||||||<|0.9669||||||Statistical significant level: 0.05|Chi-squared|||Comparson among Duration of Disease categories: <3 Months, >=3 Months and <6 Months, and >=6 Months|
1693563|NCT01072539|3114488|Superiority or Other||||||<|0.4792||||||Statistical significant level: 0.05|Chi-squared|||Sex: Male VS Sex: Female|
1693564|NCT01072539|3114488|Superiority or Other||||||<|0.0412||||||Statistical significant level: 0.05|Chi-squared|||Comparison among Age categories: <30 Years, 30 to 39 Years, 40 to 49 Years, 50 to 64 Years, and >=65 Years.|
1693565|NCT01072539|3114488|Superiority or Other||||||<|0.0067||||||Statistical significant level: 0.05|Chi-squared|||Geriatrc: <65 Years Versus (VS) Geriatrc: >=65 Years|
1693566|NCT01072539|3114489|Superiority or Other||||||<|0.0001||||||Statistical significant level: 0.05|Fisher Exact|||Comparison among subgroups of Infection Sites: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.|
1693567|NCT01072500|3114497|Superiority or Other||Hazard Ratio (HR)|0.72||||0.006|2-Sided|95.0|0.57|0.91|||Regression, Cox||||
1693568|NCT01072500|3114498|Superiority or Other||Hazard Ratio (HR)|0.82||||0.03|2-Sided|95.0|0.69|0.98|||Regression, Cox|To compare interventions, we used a likelihood ratio test from a Cox regression model, stratified by field center and sex.|||
1693569|NCT01072396|3114502|Superiority or Other||Mean Difference (Final Values)|-0.2059||||0.2417||95.0|-0.5527|0.1408||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - corssover design|
1693570|NCT01072396|3114503|Superiority or Other||Adjusted mean ratio|1.0685||||0.067||95.0|0.9953|1.147||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - corssover design|
1693571|NCT01072396|3114504|Superiority or Other||Mean Difference (Final Values)|0.06||||0.0087||95.0|0.02|0.11||Based on mixed effect model with repeated measures (MMRM) with fixed categorical effects for treatment, period and random effect for patient. Period baseline and patient baseline (average of two period baselines) were covariates in the model.|Mixed Models Analysis|Restricted maximum likelihood (REML) based MMRM||Placebo versus Tiotropium - crossover design|
1693572|NCT01072201|3114516|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups|
1693573|NCT01072201|3114517|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1693574|NCT01072201|3114518|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1693575|NCT01072188|3114519|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1693576|NCT01072188|3114520|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1693577|NCT01072175|3114554|Non-Inferiority or Equivalence|Following loge tranformation, AUC(0-tau) of dabrafenib after repeat doses from the pooled data in Part B and D were analyzed by a linear model with the following fixed effects as categorical variables: Capsule type (Gelatin or HPMC), BRAF dose (75 or 150 mg BID), Capsule type by BRAF dose interaction, Day (Day 15 or 21), MEK dose (0, 1, 1.5, 2 or 2 mg QD). Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were then provided for BRAF dose level 150 mg BID.|Geometric Mean Ratio|1.1|||||2-Sided|90.0|0.84|1.44|||||Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.||
1693598|NCT01072175|3114577|Non-Inferiority or Equivalence|Cmax of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.03|||||2-Sided|90.0|0.79|1.34|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for dabrafenib were calculated.||
1693578|NCT01072175|3114554|Non-Inferiority or Equivalence|Following loge transformation, AUC(0-tau) of dabrafenib was analyzed by a linear mixed effect model with dosing chort and day as fixed effects and subject as random effect. Based on the model, geometric mean ratio (Day 21 Dabrafenib 150 mg BID+Trametinib 2 mg QD/Day 21 Dabrafenib 150 mg BID alone) and the corresponding 90% confidence interval were provided.|Geometric Mean Ratio|1.23|||||2-Sided|90.0|0.89|1.69|||||Geometric mean ratio (Day 21 Dabrafenib 150 mg BID+Trametinib 2 mg QD/Day 21 Dabrafenib 150 mg BID alone) and the corresponding 90% confidence interval were provided.||
1693579|NCT01072175|3114556|Non-Inferiority or Equivalence|Following loge tranformation, Cmax of dabrafenib after repeat doses from the pooled data in Part B and D were analyzed by a linear model with the following fixed effects as categorical variables: Capsule type (Gelatin or HPMC), BRAF dose (75 or 150 mg BID), Capsule type by BRAF dose interaction, Day (Day 15 or 21), MEK dose (0, 1, 1.5 or 2 mg QD). Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.|Geometric Mean Ratio|1.51|||||2-Sided|90.0|1.1|2.08|||||Geometric mean ratio (HPMC/Gelatin) and the corresponding 90% CI were provided for BRAF dose level 150 mg BID.||
1693580|NCT01072175|3114564|Superiority or Other||Hazard Ratio (HR)|0.54||||0.0119|2-Sided|95.0|0.32|0.9|||Log Rank||HRs were estimated using the Pike estimator.||
1693581|NCT01072175|3114564|Superiority or Other||Hazard Ratio (HR)|0.73||||0.1667|2-Sided|95.0|0.45|1.18|||Log Rank||HRs were estimated using the Pike estimator.||
1693582|NCT01072175|3114566|Superiority or Other||Hazard Ratio (HR)|0.44|||<|0.0001|2-Sided|95.0|0.29|0.68|||Log Rank||HRs were estimated using the Pike estimator.||
1693583|NCT01072175|3114566|Superiority or Other||Hazard Ratio (HR)|0.58|||<|0.0048|2-Sided|95.0|0.38|0.87|||Log Rank||HRs were estimated using the Pike estimator.||
1693584|NCT01072175|3114567|Superiority or Other||Response rate|6.0|||||2-Sided|95.0|5.1|26.8|||||||
1693585|NCT01072175|3114568|Superiority or Other||Unconditional exact method|15.0|||||2-Sided|95.0|-4.9|33.7||||||Difference in response rate Arm3 - Arm1|
1693586|NCT01072175|3114568|Superiority or Other||Unconditional exact method|-6.0|||||2-Sided|95.0|-24.9|14.1||||||Difference in response rate Arm2- Arm1|
1693587|NCT01072175|3114569|Superiority or Other||Unconditional exact method|22.0|||||2-Sided|95.0|2.5|40.7||||||Difference in response rate Arm3 - Arm1|
1693588|NCT01072175|3114569|Superiority or Other||Unconditional exact method|-4.0|||||2-Sided|95.0|-23.1|15.9||||||Difference in response rate Arm2 - Arm1|
1693589|NCT01072175|3114576|Non-Inferiority or Equivalence|AUC(0-t) of GSK2167542 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||2-Sided|90.0|0.76|1.37|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2167542 were calculated.||
1693590|NCT01072175|3114576|Non-Inferiority or Equivalence|AUC(0-t) of GSK2298683 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||2-Sided|90.0|0.81|1.29|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2298683 were calculated.||
1693591|NCT01072175|3114576|Non-Inferiority or Equivalence|AUC(0-inf) of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.92|||||2-Sided|90.0|0.81|1.03|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for GSK2285403 were calculated.||
1693592|NCT01072175|3114576|Non-Inferiority or Equivalence|AUC(0-t) of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.02|||||2-Sided|90.0|0.84|1.25|||||Geometric mean ratio (Day 15 AUC(0-t)/ Day 1 AUC(0-t)) and 90% confidence interval for GSK2285403 were calculated.||
1693593|NCT01072175|3114576|Non-Inferiority or Equivalence|AUC(0-inf) of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.94|||||2-Sided|90.0|0.82|1.08|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for dabrafenib were calculated.||
1693594|NCT01072175|3114576|Non-Inferiority or Equivalence|AUC(0-t) of dabrafenib was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.01|||||2-Sided|90.0|0.85|1.19|||||Geometric mean ratio (Day 15 AUC(0-inf)/ Day 1 AUC(0-inf)) and 90% confidence interval for dabrafenib were calculated.||
1693595|NCT01072175|3114577|Non-Inferiority or Equivalence|Cmax of GSK2167542 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.98|||||2-Sided|90.0|0.66|1.45|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2167542 were calculated.||
1693596|NCT01072175|3114577|Non-Inferiority or Equivalence|Cmax of GSK2298683 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|1.03|||||2-Sided|90.0|0.84|1.27|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2298683 were calculated.||
1693597|NCT01072175|3114577|Non-Inferiority or Equivalence|Cmax of GSK2285403 was log e transformed and analyzed by a linear mixed effect model with fixed effect for treatment (dabrafenib alone and combined with trametinib) and participant as a random effect. Geometric mean ratio (Day 15/Day 1) and 90% confidence interval were provided.|Geometric Mean Ratio|0.99|||||2-Sided|90.0|0.78|1.25|||||Geometric mean ratio (Day 15 Cmax/Day 1 Cmax) and 90% confidence interval for GSK2285403 were calculated.||
1693602|NCT01072136|3114588|Non-Inferiority or Equivalence|Under the assumption of a clinical cure proportion of 75% for the Azithromycin/Cefixime group, a 10% non-inferiority margin (i.e., no more than a 10% lower cure rate in the placebo group) at the one-sided 0.05 significance level with 85% power required 270 study participants in each arm (540 total) using an unpooled Z-test (normal approximation). Anticipating that approximately 30% of enrolled participants would not be in the per protocol group, 772 participants were targeted for enrollment.|Risk Difference (RD)|14.0|||||1-Sided|95.0|-12.2||||||Asymptotic one-sided 95% confidence limit for the difference in clinical cure proportions(placebo minus treatment) were computed so that the lower limit could be examined relative to the non-inferiority margin of -10%.|The primary efficacy outcome was MPC clinical cure at 2 months. This was a non-inferiority trial designed to reject the null hypothesis that placebo control is inferior to empiric therapy for MPC.|
1693603|NCT01071512|3114621|Other|||||||0.9|||||||Mixed Models Analysis|||Analysis used all available data|
1693604|NCT01071512|3114622|Other|||||||0.02|||||||Mixed Models Analysis|||Analysis used all available data|
1693605|NCT01071512|3114623|Other|||||||0.3|||||||Mixed Models Analysis|||Analysis used all available data|
1693606|NCT01071512|3114624|Other|||||||0.6|||||||Mixed Models Analysis|||Analysis used all available data|
1693607|NCT01071512|3114625|Other|||||||0.17|||||||Mixed Models Analysis|||Analysis used all available data from subjects, including those who dropped out early.|
1693608|NCT01071356|3114633|Superiority or Other||Time averaged post-bline diff in diff|0.007||||0.034|2-Sided|95.0|0.001|0.013|||Random effects model||Stat Mixed Model: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended.|Stat Mixed Model Estimated was: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended. This was done because a statistical test of trend of the post-baseline effect across the 3 post interviews indicated a homogeneous post-baseline treatment effect across time for both MI1 and MI9 conditions.|
1693609|NCT01071356|3114634|Superiority or Other||Time averaged post-bline diff in diff|-0.006||||0.47|2-Sided|95.0|-0.023|0.011|||Random Effects modeling||Stat Mixed Model: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended.|Stat Mixed Model Estimated was: MI9 (Post - Bline) - MI1 (Post - Bline) taken across 2, 4, and 6 month follow-ups adjusted for gender, age, and # sessions attended. This was done because a statistical test of trend of the post-baseline effect across the 3 post interviews indicated a homogeneous post-baseline treatment effect across time for both MI1 and MI9 conditions.|
1693610|NCT01071200|3114655|Superiority or Other|||||||0.07|||||||Wilcoxon two sample test|||Change at hCG day : Wilcoxon two sample test was used to calculate p-value.|
1693611|NCT01071044|3114675|Superiority or Other|||||||0.022|||||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.|
1693612|NCT01071044|3114676|Superiority or Other|||||||0.038|||||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.|
1693613|NCT01071044|3114677|Superiority or Other|||||||0.219|||||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.|
1693614|NCT01071044|3114678|Superiority or Other|||||||0.046|||||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.|
1693615|NCT01071044|3114679|Superiority or Other|||||||0.183|||||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.|
1693616|NCT01071044|3114680|Superiority or Other|||||||0.008|||||||ANOVA|||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.|
1693617|NCT01071044|3114681|Superiority or Other|||||||0.005|||||||ANOVA|These data were initially analyzed with a one-way ANOVA.||These scores were calculated by subtracting participants' endpoint scores from their initial baseline scores. These change scores show the total change in executive functioning over the course of the trial. Higher values indicate improved executive functioning at the end of the trial compared to the beginning.|
1693618|NCT01070810|3114695|Superiority|||||||0.1|||||||Chi-squared||||
1693619|NCT01070810|3114696|Superiority|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1693620|NCT01070810|3114697|Superiority|||||||0.15|||||||t-test, 2 sided||||
1693621|NCT01070810|3114698|Superiority||Hazard Ratio (HR)|0.99||||0.97|2-Sided|95.0|0.61|1.62|||Regression, Cox|||Time to shock reversal was complicated by a high incidence of death prior to the event. To account for this we classified death as a competing risk event and used the estimated cumulative incidence function (CIF) to illustrate the comparison of CIFs between the two treatment groups using the Fine-Gray competing risk model. We tested the subdistribution hazards of these two CIF functions and obtained the estimated hazard ratio with 95% confidence intervals.|
1693622|NCT01070810|3114699|Superiority|||||||0.4|||||||Wilcoxon (Mann-Whitney)||||
1693623|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.247|||<|0.0001|2-Sided|95.0|0.138|0.441|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693624|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.32|||<|0.0086|2-Sided|95.0|0.137|0.749|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693625|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.327|||<|0.0019|2-Sided|95.0|0.162|0.662|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693626|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|2.061|||<|0.0002|2-Sided|95.0|1.401|3.032|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693627|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.285|||<|0.0028|2-Sided|95.0|1.09|1.515|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693628|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.529|||<|0.0083|2-Sided|95.0|1.116|2.097|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693629|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.226|||<|0.0018|2-Sided|95.0|0.089|0.575|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693630|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.403|||<|0.0267|2-Sided|95.0|1.04|1.892|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693631|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|4.444|||<|0.0056|2-Sided|95.0|1.547|12.766|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693632|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.604|||<|0.0223|2-Sided|95.0|1.069|2.405|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693633|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.248|||<|0.539|2-Sided|95.0|0.616|2.528|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693634|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.32|||<|0.0014|2-Sided|95.0|0.159|0.645|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693635|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.109|||<|0.0001|2-Sided|95.0|0.05|0.236|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693636|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.295|||<|0.0029|2-Sided|95.0|1.092|1.535|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693637|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.391|||<|0.0001|2-Sided|95.0|1.245|1.553|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693638|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.962|||<|0.0064|2-Sided|95.0|0.935|0.989|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693682|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.17|||<|0.0001|2-Sided|95.0|0.087|0.331|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693639|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.275|||<|0.0021|2-Sided|95.0|0.121|0.626|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693640|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.318|||<|0.001|2-Sided|95.0|0.16|0.63|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693641|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|2.086|||<|0.0001|2-Sided|95.0|1.434|3.034|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693642|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.255|||<|0.0045|2-Sided|95.0|1.073|1.467|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693643|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.66|||<|0.0009|2-Sided|95.0|1.232|2.235|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693644|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.844|||<|0.0258|2-Sided|95.0|1.077|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693645|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.112|||<|0.0247|2-Sided|95.0|1.014|1.219|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693646|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|4.495|||<|0.0024|2-Sided|95.0|1.701|11.879|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693647|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.567|||<|0.0316|2-Sided|95.0|1.04|2.359|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693648|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.195|||<|0.0001|2-Sided|95.0|1.12|1.275|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693649|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.963|||<|0.0001|2-Sided|95.0|0.956|0.97|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693650|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.475|||<|0.0001|2-Sided|95.0|1.26|1.726|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693651|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.434|||<|0.0001|2-Sided|95.0|1.288|1.596|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693652|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.708|||<|0.002|2-Sided|95.0|0.568|0.881|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694060|NCT01065454|3115346|Superiority or Other (legacy)||LS-MEANS Difference|0.01|||||2-Sided|95.0|-0.07|0.09|||||||
1693653|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.959|||<|0.0062|2-Sided|95.0|0.931|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693654|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.247|||<|0.0013|2-Sided|95.0|0.106|0.579|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693655|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.288|||<|0.0006|2-Sided|95.0|0.141|0.588|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693656|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|2.09|||<|0.0002|2-Sided|95.0|1.421|3.074|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693657|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.384|||<|0.0002|2-Sided|95.0|1.166|1.641|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693658|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.677|||<|0.0007|2-Sided|95.0|1.243|2.263|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693659|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.844|||<|0.0258|2-Sided|95.0|1.077|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693660|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.112|||<|0.0247|2-Sided|95.0|1.014|1.219|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m^2. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693661|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|4.495|||<|0.0024|2-Sided|95.0|1.701|11.879|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693662|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.567|||<|0.0316|2-Sided|95.0|1.04|2.359|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693663|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|4.298|||<|0.0189|2-Sided|95.0|1.273|14.512|||Regression, Logistic|||The statistical analysis is presented for Cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693664|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|0.969|||<|0.0001|2-Sided|95.0|0.962|0.976|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693665|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.046|||<|0.7809|2-Sided|95.0|0.763|1.432|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10^9/L at BL (>=140 - < 180 vs >=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693666|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.616|||<|0.0128|2-Sided|95.0|1.107|2.357|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10^9/L at BL (< 140 vs >=180). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693667|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.493|||<|0.0129|2-Sided|95.0|1.089|2.048|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (> 1 - 3 vs > 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693668|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.501|||<|0.0317|2-Sided|95.0|1.036|2.174|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (<=1 vs > 3). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693669|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.585|||<|0.0001|2-Sided|95.0|1.358|1.849|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693670|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.033|||<|0.0251|2-Sided|95.0|1.004|1.063|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m^2. The logistic regression analysis for relapse 24 Weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693671|NCT01070550|3114748|Superiority or Other||Odds Ratio (OR)|1.379|||<|0.0001|2-Sided|95.0|1.236|1.538|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse 24 weeks after EOT was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693672|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.726||||0.41|2-Sided|95.0|0.471|6.318|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693673|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.964||||0.3042|2-Sided|95.0|0.542|7.114|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693674|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|5.533||||0.0071|2-Sided|95.0|1.593|19.219|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693675|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.565||||0.0035|2-Sided|95.0|0.386|0.829|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (> 1.5 vs <=1.5). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693676|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.738||||0.0039|2-Sided|95.0|1.194|2.528|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693677|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.931||||0.0271|2-Sided|95.0|1.077|3.461|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693678|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|2.054||||0.0064|2-Sided|95.0|1.224|3.447|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693679|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.758||||0.0087|2-Sided|95.0|0.616|0.932|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693680|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.663||||0.0459|2-Sided|95.0|0.443|0.993|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693681|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|2.806||||0.001|2-Sided|95.0|1.514|5.201|||Regression, Logistic|||The statistical analysis is presented for on-treatment response, combined (RVR vs no RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694061|NCT01065454|3115346|Superiority or Other (legacy)||LS-MEANS Difference|0.03|||||2-Sided|95.0|-0.04|0.1|||||||
1694062|NCT01065454|3115348|Superiority or Other (legacy)||Risk Difference (RD)|-6.07|||||2-Sided|95.0|-22.26|10.13|||||||
1693683|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.733|||<|0.0204|2-Sided|95.0|0.564|0.953|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693684|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|6.928|||<|0.0001|2-Sided|95.0|4.291|11.188|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693685|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|32.176|||<|0.0001|2-Sided|95.0|20.129|51.434|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693686|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|45.894|||<|0.0001|2-Sided|95.0|27.972|75.299|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs no RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693687|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.812|||<|0.0279|2-Sided|95.0|0.674|0.978|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (> 1.5 vs <=1.5). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693688|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.128|||<|0.381|2-Sided|95.0|0.862|1.477|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693689|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.477|||<|0.0006|2-Sided|95.0|1.183|1.844|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693690|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.842|||<|0.0033|2-Sided|95.0|0.751|0.944|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693691|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.824|||<|0.0363|2-Sided|95.0|0.687|0.988|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693692|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.89|||<|0.0042|2-Sided|95.0|0.822|0.964|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693693|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.545|||<|0.0014|2-Sided|95.0|0.376|0.792|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (> 1.5 vs <=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693694|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.727|||<|0.0034|2-Sided|95.0|1.198|2.491|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693695|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|2.602|||<|0.0011|2-Sided|95.0|1.463|4.627|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693696|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|2.521|||<|0.0005|2-Sided|95.0|1.501|4.236|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693697|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.755|||<|0.0059|2-Sided|95.0|0.618|0.922|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693748|NCT01070329|3114778|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.006|2-Sided|95.0|-0.72|-0.12||This is the p-value for the main effect of treatment for the BPI Pain Interference with Walking Ability Score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693698|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.638|||<|0.0255|2-Sided|95.0|0.431|0.946|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693699|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.057|||<|0.0008|2-Sided|95.0|1.023|1.091|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693700|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.174|||<|0.0001|2-Sided|95.0|0.09|0.338|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693701|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.701|||<|0.0083|2-Sided|95.0|0.539|0.913|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693702|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.014|||<|0.0019|2-Sided|95.0|1.005|1.023|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693703|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.058|||<|0.0001|2-Sided|95.0|1.052|1.064|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693704|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.718|||<|0.0071|2-Sided|95.0|0.564|0.914|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (> 1.5 vs <=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693705|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.72|||<|0.0147|2-Sided|95.0|0.553|0.937|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (> 1 - 3 vs > 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693706|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.64|||<|0.0123|2-Sided|95.0|0.451|0.908|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (<=1 vs > 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693707|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.11|||<|0.4479|2-Sided|95.0|0.848|1.453|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693708|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.683|||<|0.0001|2-Sided|95.0|1.346|2.106|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693709|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.719|||<|0.0001|2-Sided|95.0|0.643|0.803|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693710|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.971|||<|0.0088|2-Sided|95.0|0.95|0.993|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m^2. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693711|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.896|||<|0.0074|2-Sided|95.0|0.827|0.971|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693749|NCT01070329|3114778|Superiority or Other||Mean Difference (Final Values)|-0.48||||0.004|2-Sided|95.0|-0.8|-0.15||This is the p-value for the main effect of treatment for the BPI Pain Interference with Mood score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1696417|NCT01033942|3118858|Superiority or Other|||||||0.7004|||||||Fisher Exact||||
1693712|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.047|||<|0.0001|2-Sided|95.0|1.029|1.065|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693713|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.545|||<|0.0014|2-Sided|95.0|0.376|0.792|||Regression, Logistic|||The statistical analysis is presented for AST ratio at BL (> 1.5 vs <=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693714|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.727|||<|0.0034|2-Sided|95.0|1.198|2.491|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693715|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|2.602|||<|0.0011|2-Sided|95.0|1.463|4.627|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693716|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|2.521|||<|0.0005|2-Sided|95.0|1.501|4.236|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693717|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.755|||<|0.0059|2-Sided|95.0|0.618|0.922|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693718|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.638|||<|0.0255|2-Sided|95.0|0.431|0.946|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693719|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|7.797|||<|0.0019|2-Sided|95.0|2.136|28.458|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693720|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.049|||<|0.0048|2-Sided|95.0|1.015|1.084|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693721|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.166|||<|0.0001|2-Sided|95.0|0.083|0.329|||Regression, Logistic|||The statistical analysis is presented for sex (male vs female). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693722|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.739|||<|0.0295|2-Sided|95.0|0.563|0.97|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693723|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.107|||<|0.0062|2-Sided|95.0|1.029|1.191|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693724|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.062|||<|0.0001|2-Sided|95.0|1.056|1.067|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693725|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.717|||<|0.0069|2-Sided|95.0|0.563|0.913|||Regression, Logistic|||The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (> 1.5 vs <=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693801|NCT01068743|3114996|Superiority or Other||Geometric Least Squares Mean (ng/mL)|1553.2||||||||||||||Geometric least squares means for Treatment D.|
1693726|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.742|||<|0.0262|2-Sided|95.0|0.57|0.965|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (> 1 - 3 vs > 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693727|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.656|||<|0.018|2-Sided|95.0|0.462|0.93|||Regression, Logistic|||The statistical analysis is presented for Alanine transaminase (ALT) ratio at BL (<=1 vs > 3). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693728|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.103|||<|0.4759|2-Sided|95.0|0.843|1.442|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missed vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693729|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|1.686|||<|0.0001|2-Sided|95.0|1.347|2.109|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693730|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.732|||<|0.0001|2-Sided|95.0|0.656|0.816|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at Baseline (BL) in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693731|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.966|||<|0.0042|2-Sided|95.0|0.944|0.989|||Regression, Logistic|||The statistical analysis is presented for Body Mass Index (BMI) in kilogram per square meter (kg/m^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693732|NCT01070550|3114764|Superiority or Other||Odds Ratio (OR)|0.903|||<|0.0126|2-Sided|95.0|0.833|0.978|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693733|NCT01070394|3114769|Superiority or Other|||||||0.001|||||||GEE regression model|Generalized Estimating Equation (GEE)|||
1693734|NCT01070394|3114770|Superiority or Other||||||<|0.0001|||||||GEE regression model|Generalized Estimating Equation (GEE)|||
1693735|NCT01070394|3114771|Superiority or Other||||||<|0.001|||||||GEE regression model||||
1693736|NCT01070394|3114772|Superiority or Other|||||||0.001|||||||GEE regression model|Generalized Estimating Equation (GEE)|||
1693737|NCT01070394|3114773|Superiority or Other|||||||0.569|||||||Generalized Estimating Equation|||The following p-value is for AMSES, Evening, a subset of the AMSES|
1693738|NCT01070394|3114773|Superiority or Other|||||||0.827|||||||Generalized Estimating Equation|||The following p-value is for AMSES In-Clinic, a subset of the overall AMSES|
1693739|NCT01070394|3114773|Superiority or Other|||||||0.569|||||||GEE regression model|Generalized Estimating Equation (GEE)|||
1693740|NCT01070394|3114774|Superiority or Other||||||<|0.001|||||||GEE regression model|Generalized Estimating Equation (GEE)|||
1693741|NCT01070329|3114776|Superiority or Other|||||||0.116||||||This is the p-value for Suicidal Ideation. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact||||
1693742|NCT01070329|3114777|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.001|2-Sided|95.0|-0.9|-0.49||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693743|NCT01070329|3114778|Superiority or Other||Mean Difference (Final Values)|-0.44||||0.004|2-Sided|95.0|-0.74|-0.15||This is the p-value for the main effect of treatment for the BPI Interference score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693744|NCT01070329|3114778|Superiority or Other||Mean Difference (Final Values)|-0.47||||0.006|2-Sided|95.0|-0.81|-0.14||This is the p-value for the main effect of treatment for the BPI Pain Interference with Enjoyment of Life score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693745|NCT01070329|3114778|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.037|2-Sided|95.0|-0.75|-0.02||This is the p-value for the main effect of treatment for the BPI Pain Interference with Sleep score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693746|NCT01070329|3114778|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.029|2-Sided|95.0|-0.7|-0.04||This is the p-value for the main effect of treatment for the BPI Pain Interference with Relations with Others score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693747|NCT01070329|3114778|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.012|2-Sided|95.0|-0.72|-0.09||This is the p-value for the main effect of treatment for the BPI Pain Interference with Normal Work score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693802|NCT01068743|3114996|Superiority or Other||Geometric Least Square Mean (ng/mL)|1581.4||||||||||||||Geometric least squares means for Treatment C.|
1693750|NCT01070329|3114778|Superiority or Other||Mean Difference (Final Values)|-0.43||||0.008|2-Sided|95.0|-0.75|-0.11||This is the p-value for the main effect of treatment for the BPI Pain Interference with General Activity score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693751|NCT01070329|3114778|Superiority or Other||Mean Difference (Final Values)|-0.56|||<|0.001|2-Sided|95.0|-0.86|-0.27||This is the p-value for the main effect of treatment for the BPI Severity for Pain Right Now score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693752|NCT01070329|3114778|Superiority or Other||Mean Difference (Final Values)|-0.49|||<|0.001|2-Sided|95.0|-0.75|-0.22||This is the p-value for the main effect of treatment for the BPI Severity for Average Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693753|NCT01070329|3114778|Superiority or Other||Mean Difference (Final Values)|-0.38|||<|0.003|2-Sided|95.0|-0.64|-0.13||This is the p-value for main effect of treatment for the BPI Severity for Least Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693754|NCT01070329|3114778|Superiority or Other||Mean Difference (Final Values)|-0.56|||<|0.001|2-Sided|95.0|-0.85|-0.27||This is the p-value for the main effect of treatment for the BPI Severity for Worst Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693755|NCT01070329|3114779|Superiority or Other|||||||0.021||||||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact||||
1693756|NCT01070329|3114780|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.002|2-Sided|95.0|-0.93|-0.22||This is the p-value for the Change from Baseline up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA||||
1693757|NCT01070329|3114780|Superiority or Other||Mean Difference (Final Values)|-0.54||||0.007|2-Sided|95.0|-0.93|-0.15||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693758|NCT01070329|3114781|Superiority or Other||Mean Difference (Final Values)|-2.07|||||2-Sided|95.0|-3.18|-0.96|||||||
1693759|NCT01070329|3114782|Superiority or Other||Mean Difference (Final Values)|1.81||||0.004|2-Sided|95.0|0.6|3.02||This is the p-value for the Change from Baseline in DBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA||||
1693760|NCT01070329|3114782|Superiority or Other||Mean Difference (Final Values)|1.7||||0.063|2-Sided|95.0|-0.09|3.5||This is the p-value for the Change from Baseline in SBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA||||
1693761|NCT01070329|3114782|Superiority or Other||Mean Difference (Final Values)|1.8||||0.007|2-Sided|95.0|0.5|3.1||This is the p-value for the Change from Baseline in DBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693762|NCT01070329|3114782|Superiority or Other||Mean Difference (Final Values)|1.91||||0.05|2-Sided|95.0|0.0|3.82||This is the p-value for the Change from Baseline in SBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693763|NCT01070329|3114783|Superiority or Other||Mean Difference (Final Values)|1.39||||0.071|2-Sided|95.0|-0.12|2.9||This is the p-value for the Change up to Week 8. P-values were not adjusted for multiple comparisons; a priori statistical significance was 0.05.|ANCOVA||||
1693764|NCT01070329|3114783|Superiority or Other||Mean Difference (Final Values)|1.67||||0.05|2-Sided|95.0|0.0|3.34||This is the p-value for the Change at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1693765|NCT01070329|3114784|Superiority or Other||Mean Difference (Final Values)|-2.81|||||2-Sided|95.0|-4.13|-1.48|||||||
1693766|NCT01070329|3114785|Superiority or Other|||||||0.173||||||This third gated secondary outcome measure failed to meet statistical significance. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes.|Cochran-Mantel-Haenszel||||
1693767|NCT01070329|3114786|Superiority or Other||||||<|0.001||||||This is the second gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p>0.05).|Cochran-Mantel-Haenszel||||
1693768|NCT01070329|3114787|Superiority or Other||Mean Difference (Final Values)|-2.88|||<|0.001|2-Sided|95.0|-4.16|-1.61||P-value for the SDS Total score. First gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 5 secondary outcomes with stepwise comparisons of treatments until outcome failed to be significant (p>0.05).|Mixed Models Analysis||||
1693769|NCT01070329|3114787|Superiority or Other||Mean Difference (Final Values)|-0.95|||<|0.001|2-Sided|95.0|-1.41|-0.49||This is the p-value for the Disrupt Family Life/Home score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis||||
1693770|NCT01070329|3114787|Superiority or Other||Mean Difference (Final Values)|-0.97|||<|0.001|2-Sided|95.0|-1.42|-0.53||This the p-value for the Disrupt Social Life/Leisure score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis||||
1693771|NCT01070329|3114787|Superiority or Other||Mean Difference (Final Values)|-0.95|||<|0.001|2-Sided|95.0|-1.47|-0.42||This is the p-value for the Disrupt Work/School Work score. The p-value is not adjusted for multiple comparisons.|Mixed Models Analysis||||
1693772|NCT01070329|3114788|Superiority or Other||Mean Difference (Final Values)|-4.2|||<|0.001|2-Sided|95.0|-5.77|-2.62||The a priori threshold for statistical significance is 0.05.|Mixed Models Analysis||||
1693773|NCT01070329|3114789|Superiority or Other||Mean Difference (Final Values)|-0.49|||<|0.001|2-Sided|95.0|-0.75|-0.22||The P-value is for the main effect of treatment. The a priori threshold for statistical significance is 0.05.|Mixed Models Analysis||||
1693803|NCT01068743|3114996|Superiority or Other||Geometric Least Square Means (ng/mL)|1715.8||||||||||||||Geometric least squares means for Treatment B.|
1693774|NCT01069939|3114843|Superiority or Other||Hazard Ratio (HR)|0.09|||<|0.001|2-Sided|96.65|0.02|0.41||An interim analysis was done so that the significance level was adjusted using the Pocock-like alpha-spending function with Lan-DeMets approach. The adjusted significance level was the two-sided 3.35%.|Log Rank|||The above two groups were compared.|
1693775|NCT01069484|3114908|Superiority or Other||Risk Ratio (RR)|0.84||||0.51|2-Sided|95.0|0.49|1.42||P-values < 0.05 were considered significant.|Mantel Haenszel||"Pelvic floor muscle training arm represents the numerator for relative risk and usual care arm represents the denominator for relative risk"|Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of “last observation carried forward” was used.|
1693776|NCT01069484|3114909|Non-Inferiority or Equivalence|Power calculation was based on the study by Mørkved and Bø (1997), showing 67% prevalence reduction of UI in the PFMT group and 34% reduction in the control group. Assuming a similar effect, two-sided significance of <0.05, and a power of 0.90, required a total of 62 women. Stratified analysis on major levator ani (LA) muscle defects was planned, but the effect of PFMT in women with such defects was unknown. The statistical advice was to aim for 80 women with- and 80 women without such defects.|Risk Ratio (RR)|0.89||||0.57|2-Sided|95.0|0.6|1.32||P-values < 0.05 were considered significant.|Mantel Haenszel||"Pelvic floor muscle training arm represents the numerator for relative risk and usual care arm represents the denominator for relative risk"|Intention to treat was the principal analysis. Missing values for categorical data (self-reported UI) the approach of “last observation carried forward” was used.|
1693777|NCT01069354|3114916|Superiority or Other|||||||0.3197||||||Paired t-test|t-test, 2 sided||||
1693778|NCT01069354|3114917|Superiority or Other|||||||0.5663||||||Paired t-test|t-test, 2 sided||||
1693779|NCT01069354|3114918|Superiority or Other||||||<|0.0001||||||Paired t-test|t-test, 2 sided||||
1693780|NCT01069354|3114919|Superiority or Other||||||<|0.0001||||||Paired t-test|t-test, 2 sided||||
1693781|NCT01069354|3114920|Superiority or Other||||||<|0.0001||||||Paired t-test|t-test, 2 sided||||
1693782|NCT01069354|3114921|Superiority or Other||||||<|0.0001||||||Paired t-test|t-test, 2 sided||||
1693783|NCT01069354|3114922|Superiority or Other||||||<|0.0001||||||Binomial proportion, two-sided Fisher’s exact test|Fisher Exact|||91 (90.1%) of 101 subjects had a ≥ 2.0 cm lower VAS Score in treatment versus control NLF at Time 0|
1693784|NCT01069354|3114923|Superiority or Other||Mean Difference (Net)|-4.41|||<|0.0001|2-Sided|||||Paired t-test|t-test, 2 sided||||
1693785|NCT01068964|3114963|Non-Inferiority or Equivalence|A non-inferiority margin of 1.5 mmHg was used. That is, if the upper limit of the 95% confidence interval for the difference in the mean diurnal IOP change between the two groups (Group 1 minus Group 2) is less than 1.5 mm Hg, then the null hypothesis will be rejected. The study had an 85% power.|Mean Difference (Final Values)|-0.556|||||2-Sided|95.0|-1.68|0.57||||||A non-inferiority test was performed for comparing the change from baseline in mean diurnal IOP at Week 4 between treatment groups. The null hypothesis was that the mean diurnal IOP change at Week 4 for Group 1 was at least 1.5 mmHg greater than that for Group 2. The hypothesis was tested using a confidence interval approach based on a 2-way analysis of variance (ANOVA) model including factors for treatment and investigator.|
1693786|NCT01068912|3114964|Superiority or Other|||||||0.05||||||A step-down approach was applied to the primary analysis, with the higher dose of favipiravir first tested against placebo.|Gehan-Wilcoxon|||Time required from first study drug administration to alleviation of the 6 primary influenza symptoms and fever. The primary influenza symptoms included cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue. Symptoms were considered alleviated when all were decreased to ≤1 and decrease persisted unchanged ≥ 21.5 hours. Fever was considered alleviated when maintained at < 38.0°C (age 20 to < 65 years) or < 37.8°C (age ≥ 65 years) ≥ 21.5 hours.|
1693787|NCT01068821|3114981|Superiority or Other|||||||0.5|||||||Fisher Exact|||Fischer's exact test, significance defined as p<0.05|
1693788|NCT01068821|3114982|Superiority or Other|||||||0.1|||||||t-test, 2 sided|||Sample size calculations (yielding 25 patients per group): two-sided 5% significance level and a power of 80% for detection of a 2 cm (SD 2.5 cm) difference. Continuous variables analyzed by Student’s T-test and One way Analysis of Variance (ANOVA) with statistical significance: p value ≤ 0.05 or 95% Confidence Interval excluding one. Confirmation by Wilcoxon Rank-Sum/Mann-Whitney and Kruskal-Wallis tests. Categorical variables by Chi Square Test, confirmed by Fisher’s Exact test.|
1693789|NCT01068743|3114988|Superiority or Other||Geometric Least Squares Mean (ng*h/mL)|11734.0|||||||||||||Geometric least squares means for Treatment D.||
1693790|NCT01068743|3114988|Superiority or Other||Geometric Least Squares Mean (ng*h/mL)|11845.0|||||||||||||Geometric least squares means for Treatment C.||
1693791|NCT01068743|3114988|Superiority or Other||Geometric Least Squares Mean (ng*h/mL)|11875.0|||||||||||||Geometric least squares means for Treatment B.||
1693792|NCT01068743|3114988|Superiority or Other||Geometric Least Squares Mean (ng*h/mL)|11827.0|||||||||||||Geometric least squares means for Treatment A.||
1693793|NCT01068743|3114988|Superiority or Other||Ratio (%) of Geometric LS Means|99.06|||||2-Sided|90.0|96.19|102.02|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.||
1693794|NCT01068743|3114988|Superiority or Other||Ratio (%) of Geometric LS Means|100.41|||||2-Sided|90.0|95.4|105.68|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.||
1693795|NCT01068743|3114991|Superiority or Other||Geometric Least Squares Mean (ng*h/mL)|52.17|||||||||||||Geometric least squares means for Treatment D.||
1693796|NCT01068743|3114991|Superiority or Other||Geometric Least Squares Mean (ng*h/mL)|50.89|||||||||||||Geometric least squares means for Treatment C.||
1693797|NCT01068743|3114991|Superiority or Other||Geometric Least Squares Mean (ng*h/mL)|47.83|||||||||||||Geometric least squares means for Treatment B.||
1693798|NCT01068743|3114991|Superiority or Other||Geometric Least Squares Mean (ng*h/mL)|47.15|||||||||||||Geometric least squares means for Treatment A.||
1693799|NCT01068743|3114991|Superiority or Other||Ratio (%) of Geometric LS Means|102.52|||||2-Sided|90.0|99.56|105.57|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.||
1693800|NCT01068743|3114991|Superiority or Other||Ratio (%) of Geometric LS Means|101.43|||||2-Sided|90.0|98.07|104.9|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.||
1693805|NCT01068743|3114996|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|98.22|||||2-Sided|90.0|94.28|102.32|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1693806|NCT01068743|3114996|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|99.5|||||2-Sided|90.0|90.41|109.5|||||Ratio=Treatment B/Treatment A. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1693807|NCT01068743|3114997|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|11937.0||||||||||||||Geometric least squares means for Treatment D.|
1693808|NCT01068743|3114997|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|12036.0||||||||||||||Geometric least squares means for Treatment C.|
1693809|NCT01068743|3114997|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|12250.0||||||||||||||Geometric least squares means for Treatment B.|
1693810|NCT01068743|3114997|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|11998.0||||||||||||||Geometric least squares mean for Treatment A.|
1693811|NCT01068743|3114997|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|99.17|||||2-Sided|90.0|96.23|102.21|||||Ratio=Treatment D/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1693812|NCT01068743|3114997|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of metformin.|Ratio (%) of Geometric LS Means|102.1|||||2-Sided|90.0|97.26|107.18|||||Ratio = Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the FDC tablet versus metformin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 99% power to conclude BE with respect to each of Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would provide 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1693813|NCT01068743|3114998|Superiority or Other||Geometric Least Squares Mean (ng/mL)|10.97||||||||||||||Geometric least squares means for Treatment D.|
1693814|NCT01068743|3114998|Superiority or Other||Geometric Least Squares Mean (ng/mL)|10.33||||||||||||||Geometric least squares means for Treatment C.|
1693815|NCT01068743|3114998|Superiority or Other||Geometric Least Squares Mean (ng/mL)|9.97||||||||||||||Geometric least squares means for Treatment B.|
1693816|NCT01068743|3114998|Superiority or Other||Geometric Least Squares Mean (ng/mL)|9.73||||||||||||||Geometric least squares means for Treatment A.|
1693817|NCT01068743|3114998|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|106.24|||||2-Sided|90.0|98.43|114.66|||||Ratio=Treatment D/Treatment C. Geometric least squares means values presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1693818|NCT01068743|3114998|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|102.46|||||2-Sided|90.0|94.68|110.88|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1693819|NCT01068743|3115001|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|53.99||||||||||||||Geometric least squares means for Treatment D.|
1693820|NCT01068743|3115001|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|52.71||||||||||||||Geometric least squares means for Treatment C.|
1693821|NCT01068743|3115001|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|49.94||||||||||||||Geometric least squares means for Treatment B.|
1693822|NCT01068743|3115001|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|49.23||||||||||||||Geometric least squares means for Treatment A.|
1693856|NCT01068418|3115061|Superiority or Other||||||<|0.01||||||threshold for significance was P<0.05.|Mixed Models Analysis|||A repeated measures regression analysis model was used to examine the effect of vitamin D3 therapy on the renal plasma flow (mean of three measurements at each time point) before and during angiotensin II infusions, before and after vitamin D3 therapy.|
1693823|NCT01068743|3115001|Non-Inferiority or Equivalence|BE was concluded if the 90% CIs for the test-to-reference ratios (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|102.43|||||2-Sided|90.0|99.53|105.42|||||Ratio=Treatment D/Treatment C. Geometric least squares means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf,respectively.|
1693824|NCT01068743|3115001|Non-Inferiority or Equivalence|BE was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf of saxagliptin.|Ratio (%) of Geometric LS Means|101.45|||||2-Sided|90.0|98.17|104.84|||||Ratio=Treatment B/Treatment A. Geometric least squares means values are presented in other statistical analysis entries. LS=Least Squares.|If there was no difference between the bioavailabilities of saxagliptin from the FDC tablet versus saxagliptin from coadministration of saxagliptin and metformin tablets under both fasted and fed conditions, then 20 participants would have provided 98% and 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf, respectively. If there was a 5% difference, then 20 participants would have provided 93% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1693825|NCT01068730|3115002|Superiority or Other||[Geometric Least Squares Mean (ng*hr/mL)|11327.0||||||||||||||Geometric least squares means for Treatment D|
1693826|NCT01068730|3115002|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|11391.0||||||||||||||Geometric least squares means for Treatment C|
1693827|NCT01068730|3115002|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|7127.4||||||95.0||||||||Geometric least squares means for Treatment B|
1693828|NCT01068730|3115002|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|6907.1||||||||||||||Geometric least squares means for Treatment A|
1693829|NCT01068730|3115002|Superiority or Other||Ratio (%) of Geometric LS Means|99.44|||||2-Sided|95.0|96.08|102.92|||||Ratio=Treatment D/Treatment C. Geometric LS means values are presented in other statistical analysis entries.||
1693830|NCT01068730|3115002|Superiority or Other||Ratio (%) of Geometric LS Means|103.19|||||2-Sided|95.0|99.75|106.75|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.||
1693831|NCT01068730|3115012|Superiority or Other||Geometric Least Squares Mean (ng/mL)|1621.6||||||||||||||Geometric least squares means for Treatment D|
1693832|NCT01068730|3115012|Superiority or Other||Geometric Least Squares Mean (ng/mL)|1643.8||||||||||||||Geometric least squares means for Treatment C|
1693833|NCT01068730|3115012|Superiority or Other||Geometric Least Squares Mean (ng/mL)|1024.9||||||||||||||Geometric least squares means for Treatment B|
1693834|NCT01068730|3115012|Superiority or Other||Geometric Least Squares Mean (ng/mL)|1013.6||||||||||||||Geometric least squares means for Treatment A|
1693835|NCT01068730|3115012|Non-Inferiority or Equivalence|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|98.65|||||2-Sided|95.0|93.94|103.59|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1693836|NCT01068730|3115012|Non-Inferiority or Equivalence|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|101.12|||||2-Sided|95.0|96.36|106.11|||||Ratio=Treatment B/Treatment A. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1693837|NCT01068730|3115013|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)]|11641.0||||||95.0||||||||Geometric least squares means for Treatment D|
1693838|NCT01068730|3115013|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|11680.0||||||||||||||Geometric least squares means for Treatment C|
1693839|NCT01068730|3115013|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|7245.2||||||||||||||Geometric least squares means for Treatment B|
1693840|NCT01068730|3115013|Superiority or Other||Geometric Least Squares Mean (ng*hr/mL)|7062.8||||||||||||||Geometric least squares means for Treatment A|
1693841|NCT01068730|3115013|Non-Inferiority or Equivalence|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|99.67|||||2-Sided|95.0|96.16|103.31|||||Ratio=Treatment D/Treatment C. Geometric LS means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude BE with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1693857|NCT01068418|3115062|Superiority or Other||||||<|0.05||||||Threshold for significance was P<0.05.|Mixed Models Analysis|||A repeated measures regression analysis model was used to examine the effect of vitamin D3 therapy on the mean arterial pressure (mean of five measurements at each time point) before and during angiotensin II infusions, before and after vitamin D3 therapy.|
1693858|NCT01068262|3115067|Superiority or Other||Estimate|0.95|||||2-Sided|90.0|0.66|1.35|||||||
1693842|NCT01068730|3115013|Non-Inferiority or Equivalence|Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test-to-reference ratios (B/A) and (D/C) of geometric means were entirely contained within 80% to 125% for both Cmax and AUC0-inf.|Ratio (%) of Geometric LS Means|102.58|||||2-Sided|95.0|99.07|106.23|||||Ratio=Treatment B/Treatment A. Geometric least squares (LS) means values are presented in other statistical analysis entries.|If there was no difference between the bioavailabilities of metformin from the 500-mg or 1000-mg Glucophage tablets manufactured by BMS and 500-mg or 1000-mg Diabex tablets manufactured in Australia by Alphapharm, then 20 subjects would have provided 99% power to conclude bioequivalence (BE) with respect to Cmax and AUC0-inf. If there was a 5% difference, then 20 subjects would have provided 97% and 99% power to conclude BE with respect to Cmax and AUC0-inf, respectively.|
1693843|NCT01068717|3115015|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.77|||||2-Sided|95.0|96.82|109.09||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)], and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.|
1693844|NCT01068717|3115015|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.04|||||2-Sided|95.0|92.9|105.59||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)], and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.|
1693845|NCT01068717|3115016|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio (%) of geometric LS mean|99.22||||||90.0|96.48|102.04||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)], and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.|
1693846|NCT01068717|3115016|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio (%) of geometric LS mean|102.64|||||2-Sided|90.0|98.31|107.16||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)], and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.|
1693847|NCT01068717|3115017|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|101.82|||||2-Sided|90.0|96.1|107.88||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)], and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.|
1693848|NCT01068717|3115017|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.34|||||2-Sided|90.0|97.96|106.91||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)], and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.|
1693859|NCT01068262|3115068|Superiority or Other||GMR|0.93|||||2-Sided|90.0|0.82|1.04|||||||
1693860|NCT01068262|3115069|Superiority or Other||Estimate|0.9|||||2-Sided|90.0|0.75|1.07|||||||
1693849|NCT01068717|3115022|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.78|||||2-Sided|90.0|96.61|103.05||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)], and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.|
1693850|NCT01068717|3115022|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|102.34|||||2-Sided|90.0|97.96|106.91||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)], and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.|
1693851|NCT01068717|3115024|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|100.21|||||2-Sided|90.0|96.86|103.67||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)], and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.|
1693852|NCT01068717|3115024|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|99.02|||||2-Sided|90.0|91.29|107.41||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)], and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states|
1693853|NCT01068717|3115025|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric LS mean|100.37|||||2-Sided|90.0|85.7|117.56||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)], and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.|
1693854|NCT01068717|3115025|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals (CIs) were calculated for Treatment B to Treatment A and Treatment D to Treatment C ratios of geometric means for Cmax, AUC(INF), and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% CIs for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|Ratio geometric least squares (LS) mean|109.53|||||2-Sided|90.0|102.67|116.85||||||To demonstrate the bioequivalence of FDC tablet versus coadministration of saxagliptin and metformin tablets in the fasted and fed states, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)], and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period, and treatment as fixed effects and measurements within each subject as repeated measurements allowing for different covariance structures for the fasted and fed states.|
1693855|NCT01068652|3115046|Non-Inferiority or Equivalence|The treatment comparison was based on a non-inferiority criterion and the following hypotheses were tested: H0: μDetemir - μBIAsp 30 ≥0.4% against the alternative hypothesis (Detemir non-inferior to BIAsp 30) HA: μDetemir - μBIAsp 30 <0.4% where μBIAsp 30 and μDetemir are the mean HbA1c after 50 weeks of treatment with the two treatment regimens.|Mean Difference (Final Values)|0.11||||0.3406||95.0|-0.12|0.34|||ANCOVA|||To investigate the effect of different treatments, an analysis of covariance (ANCOVA) model was used to analyse HbA1c at week 50 with treatment group (2 categories: insulin detemir and aspart; BIAsp 30), country and pre-trial OAD(s) treatment (one OAD vs. more OADs) as factors and HbA1c at baseline (week 0) as a covariate. The treatment difference was estimated and a 95% confidence interval (CI) for the difference was calculated.|
1693861|NCT01068262|3115070|Superiority or Other||Mean Difference (Final Values)|0.1|||||2-Sided|90.0|-14.7|14.9|||||||
1696418|NCT01033942|3118859|Superiority or Other|||||||0.377|||||||Fisher Exact||||
1693863|NCT01067768|3115106|Superiority or Other|||||||0.016||||||The difference between groups was evaluated with a U test Mann Whitney. The difference was statistically significant with p values less than 0.05|Wilcoxon (Mann-Whitney)|||Null hypothesis: On average catheterization are the same in patients with daily review of the indication and control group patients|
1693864|NCT01067768|3115107|Superiority or Other||Risk Ratio (RR)|0.81|||||2-Sided|95.0|0.5|1.3|||||The primary outcome analysis was performed using relative risk (RR) between the rate of urinary tract infection per 1,000 days of exposure of the test subjects to intervention and that of patients undergoing routine care.|The sample size was calculated for the primary outcome. An infection rate 15 per 1,000 urinary catheter days in the control group and an expected reduction in the intervention group 40% clinically important effect. Mapping one to one, 5% alpha error and beta error 20%.|
1693865|NCT01067521|3115113|Superiority||Mean Difference (Final Values)|0.017|Standard Error of the Mean|0.106||0.8701|2-Sided|95.0|-0.91|0.225||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 36|
1693866|NCT01067521|3115113|Superiority||Mean Difference (Final Values)|-0.086|Standard Error of the Mean|0.05||0.0844|2-Sided|95.0|-0.184|0.012||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 12|
1693867|NCT01067521|3115113|Superiority||Mean Difference (Final Values)|-0.084|Standard Error of the Mean|0.041||0.0425|2-Sided|95.0|-0.166|-0.003||not adjusted for multiplicity|Mixed model for repeated measures (MMRM)||Early Start vs Delayed Start|Month 6|
1693868|NCT01067521|3115114|Superiority||Risk Ratio (RR)|0.663|Standard Error of the Mean|0.086||0.0015|2-Sided|95.0|0.514|0.854||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 36|
1693869|NCT01067521|3115114|Superiority||Risk Ratio (RR)|0.514|Standard Error of the Mean|0.073|<|0.0001|2-Sided|95.0|0.388|0.679||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 12|
1693870|NCT01067521|3115114|Superiority||Risk Ratio (RR)|0.556|Standard Error of the Mean|0.093|<|0.0005|2-Sided|95.0|0.4|0.773||not adjusted for multiplicity|Negative Binomial Regression||Early Start vs Delayed Start|Month 6|
1693871|NCT01067521|3115115|Superiority||Risk Ratio (RR)|0.666|Standard Error of the Mean|0.061|<|0.0001|2-Sided|95.0|0.557|0.797||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 36 Negative binomial regression|
1693872|NCT01067521|3115115|Superiority||Risk Ratio (RR)|0.633|Standard Error of the Mean|0.061|<|0.0001|2-Sided|95.0|0.524|0.765||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 12 Negative binomial regression|
1693873|NCT01067521|3115115|Superiority||Risk Ratio (RR)|0.736|Standard Error of the Mean|0.081|<|0.0056|2-Sided|95.0|0.592|0.914||not adjusted for multiplicity|Negative binomial regression||Early Start vs Delayed Start|Month 6 Negative binomial regression|
1693874|NCT01067521|3115116|Superiority||Risk Ratio (RR)|0.8332|Standard Error of the Mean|0.0744||0.0409|2-Sided|95.0|0.6995|0.9925||not adjusted for multiplicity|Negative Binomial Regression||Early Start vs Delayed Start|Entire Study The Negative Binomial Regression model covariates: • treatment group • PCBL (Placebo-Controlled Baseline) Kurtzke’s Expanded Disability Status Scale (EDSS) score as 1 degree of freedom variable • Log of the # of relapses in the 2 years prior to PCBL • Volume of T2 lesions at PCBL • Status of Gd-enhancing T1 lesion activity at PCBL (=0 if no Gd-enhancing T1 lesions at PCBL; =1 if at least one Gd-enhancing T1 lesion at PCBL) • Country or Geographical Region (CGR)|
1693875|NCT01067521|3115117|Superiority||Mean Difference (Final Values)|-0.061|Standard Error of the Mean|0.048||0.2058|2-Sided|95.0|-0.154|0.033||The overall significance level for this study is 5%|ANCOVA||GA 40 mg vs Placebo||
1693876|NCT01067521|3115118|Superiority||Risk Ratio (RR)|0.552|Standard Error of the Mean|0.066|<|0.0001|2-Sided|95.0|0.436|0.699||The overall significance level for this study is 5%|Negative Binomial Regression||GA 40 mg vs. placebo||
1693877|NCT01067521|3115119|Superiority||Risk Ratio (RR)|0.653|Standard Error of the Mean|0.059|<|0.0001|2-Sided|95.0|0.546|0.78||The overall significance level for this study is 5%|Negative binomial regression||GA 40 mg vs. placebo|Negative binomial regression|
1693878|NCT01067521|3115120|Superiority||Risk Ratio (RR)|0.656|Standard Error of the Mean|0.066|<|0.0001|2-Sided|95.0|0.539|0.799||The overall significance level for this study is 5%|Negative Binomial Regression||GA 40 mg vs. placebo|Relapses were estimated by a baseline-adjusted, Negative Binomial Regression with an “offset” based on the log of subject’s exposure to treatment. The model included the following covariates: - Baseline EDSS score. - Log of the prior 2-year number of relapses. - Volume of T2 lesions at baseliner. - Status of Gd-enhancing T1 activity at baseline (=0 no Gd-enhancing T1 at baseline; =1 at least one Gd-enhancing T1 at baseline). - CGR.|
1693879|NCT01067508|3115121|Other|||||||0.68||||||p<0.05 was defined as significant|t-test, 2 sided|||Comparison was made to the 12 week minus baseline change in Aquafina (control) group|
1693880|NCT01067508|3115121|Other|||||||0.003||||||p<0.05 was defined as significant|t-test, 2 sided|||Comparison was made to 12 weeks minus baseline change in Fiji water group|
1693881|NCT01067456|3115130|Superiority or Other||Median Difference (Final Values)|0.57||||0.79|2-Sided||||||t-test, 2 sided||||
1693882|NCT01067326|3115136|Superiority or Other|||||||0.94|||||||t-test, 2 sided|||P-value for intergroup comparison of change from baseline to month 4|
1693883|NCT01067326|3115137|Superiority or Other|||||||0.04|||||||t-test, 2 sided|||Difference in diastolic blood pressure from baseline to 4 months.|
1693884|NCT01067326|3115138|Superiority or Other|||||||0.006|||||||t-test, 2 sided|||Difference in systolic blood pressure from baseline to 4 months.|
1693885|NCT01067326|3115139|Superiority or Other|||||||0.02|||||||t-test, 2 sided|||Change in EPCs from baseline to 4 months|
1693886|NCT01066897|3115195|Superiority or Other||Mean Difference (Net)|0.368|Standard Deviation|0.44||0.067|2-Sided||||||t-test, 2 sided|One sample t-test to determine if the % change in HAMD was different from 0||For the 2 dropouts, used LOCF.|
1693887|NCT01066897|3115196|Other|||||||0.002|||||||Chi-squared||||
1693888|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|27.25|||<|0.0001|2-Sided|95.0|6.729|110.35|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs RVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694063|NCT01065454|3115348|Superiority or Other (legacy)||Risk Difference (RD)|-9.46|||||2-Sided|95.0|-24.32|5.39|||||||
1693889|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|0.184|||<|0.1501|2-Sided|95.0|0.018|1.845|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693890|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|0.076|||<|0.0255|2-Sided|95.0|0.008|0.729|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693891|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|0.016|||<|0.0006|2-Sided|95.0|0.001|0.169|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs NO RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693892|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|0.401|||<|0.0071|2-Sided|95.0|0.206|0.78|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693893|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|0.848|||<|0.0017|2-Sided|95.0|0.765|0.94|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693894|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|0.848|||<|0.0017|2-Sided|95.0|0.765|0.94|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693895|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|0.969|||<|0.0012|2-Sided|95.0|0.951|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693896|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|0.906|||<|0.8518|2-Sided|95.0|0.321|2.559|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (> 1 - 3 vs > 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693897|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|2.372|||<|0.1075|2-Sided|95.0|0.829|6.789|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (<=1 vs > 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693898|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|1.745|||<|0.0156|2-Sided|95.0|1.111|2.741|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693899|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|0.441|||<|0.0162|2-Sided|95.0|0.226|0.859|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693900|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|0.969|||<|0.0012|2-Sided|95.0|0.951|0.988|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693901|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|0.906|||<|0.8518|2-Sided|95.0|0.321|2.559|||Regression, Logistic|||The statistical analysis is presented for ALT ratio at BL (> 1 - 3 vs > 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693902|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|2.372|||<|0.1075|2-Sided|95.0|0.829|6.789|||Regression, Logistic|||The statistical analysis is presented for Alanine Aminotransferase (ALT) ratio at BL (<=1 vs > 3). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693903|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|1.745|||<|0.0156|2-Sided|95.0|1.111|2.741|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693904|NCT01066819|3115212|Superiority or Other||Odds Ratio (OR)|0.441|||<|0.0162|2-Sided|95.0|0.226|0.859|||Regression, Logistic|||The statistical analysis is presented for Sex (MALE vs FEMALE). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693905|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|4.921||||0.0035|2-Sided|95.0|1.686|14.362|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1693906|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.112|||<|0.0001|2-Sided|95.0|1.068|1.158|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1693907|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.112|||<|0.0001|2-Sided|95.0|1.068|1.158|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1693908|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|11.342|||<|0.0001|2-Sided|95.0|3.977|32.347|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693909|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.822|||<|0.0037|2-Sided|95.0|1.216|2.732|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693910|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|5.557|||<|0.0001|2-Sided|95.0|2.405|12.838|||Regression, Logistic|||The statistical analysis is presented for On-treatment response, combined (RVR vs NO RVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693911|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.563|||<|0.0041|2-Sided|95.0|1.152|2.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693912|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|14.527|||<|0.0105|2-Sided|95.0|1.872|112.73|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (pEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693913|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|77.905|||<|0.0001|2-Sided|95.0|10.521|576.85|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (cEVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693914|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|134.6|||<|0.0001|2-Sided|95.0|17.956|1009.0|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs NO RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693915|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|3.684|||<|0.0437|2-Sided|95.0|1.037|13.083|||Regression, Logistic|||The statistical analysis is presented for (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693916|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|0.599|||<|0.2|2-Sided|95.0|0.273|1.312|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693917|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|0.981|||<|0.9557|2-Sided|95.0|0.506|1.903|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693918|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|3.615|||<|0.0205|2-Sided|95.0|1.219|10.721|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693948|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.505||||0.596|2-Sided|95.0|0.04|6.318|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693919|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.262|||<|0.0001|2-Sided|95.0|1.154|1.38|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693920|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.945|||<|0.0058|2-Sided|95.0|1.213|3.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693921|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.262|||<|0.0001|2-Sided|95.0|1.154|1.38|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693922|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.945|||<|0.0058|2-Sided|95.0|1.213|3.12|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693923|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|0.894|||<|0.0099|2-Sided|95.0|0.821|0.973|||Regression, Logistic|||The statistical analysis is presented for Cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693924|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.276|||<|0.0001|2-Sided|95.0|1.177|1.383|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693925|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|0.814|||<|0.0289|2-Sided|95.0|0.676|0.979|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, 1st 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693926|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.227|||<|0.0001|2-Sided|95.0|1.151|1.308|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693927|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.185|||<|0.0033|2-Sided|95.0|1.058|1.326|||Regression, Logistic|||The statistical analysis is presented for Cumulative PEG-IFN alfa-2a dose per 1000 ug. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693928|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.061|||<|0.0001|2-Sided|95.0|1.042|1.08|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693929|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.179|||<|0.6327|2-Sided|95.0|0.601|2.311|||Regression, Logistic|||The statistical analysis is presented for average number of drinks per week (> 1 vs 0). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693930|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|3.472|||<|0.0139|2-Sided|95.0|1.288|9.357|||Regression, Logistic|||The statistical analysis is presented for average number of drinks per week (1 vs 0). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693931|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|0.695|||<|0.0125|2-Sided|95.0|0.523|0.925|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10(IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693932|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|5.424|||<|0.017|2-Sided|95.0|1.353|21.749|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694045|NCT01065454|3115341|Superiority or Other (legacy)||LS-MEANS Difference|0.0|||||2-Sided|95.0|-0.04|0.05|||||||
1694046|NCT01065454|3115341|Superiority or Other (legacy)||LS-MEANS Difference|0.0|||||2-Sided|95.0|-0.04|0.03|||||||
1693933|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|0.74|||<|0.4846|2-Sided|95.0|0.317|1.723|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693934|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|0.903|||<|0.7821|2-Sided|95.0|0.439|1.857|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693935|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|6.136|||<|0.0035|2-Sided|95.0|1.819|20.701|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693936|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|1.078|||<|0.0001|2-Sided|95.0|1.062|1.094|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693937|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|5.38|||<|0.014|2-Sided|95.0|1.405|20.597|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (OTHER vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693938|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|0.743|||<|0.4786|2-Sided|95.0|0.327|1.688|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (HISPANIC vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693939|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|0.989|||<|0.9755|2-Sided|95.0|0.497|1.967|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (BLACK vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693940|NCT01066819|3115229|Superiority or Other||Odds Ratio (OR)|5.596|||<|0.0045|2-Sided|95.0|1.704|18.378|||Regression, Logistic|||The statistical analysis is presented for Ethnic origin (ASIAN vs WHITE/CAUCASIAN). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week [Wk] 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693941|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|2.142||||0.6258|2-Sided|95.0|0.1|45.801|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693942|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.35||||0.4457|2-Sided|95.0|0.024|5.194|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693943|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.141||||0.1439|2-Sided|95.0|0.01|1.951|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693944|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.393||||0.0833|2-Sided|95.0|0.137|1.131|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a|
1693945|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.154||||0.004|2-Sided|95.0|0.043|0.551|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693946|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.113||||0.0452|2-Sided|95.0|1.002|1.236|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693947|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|2.051||||0.0033|2-Sided|95.0|1.27|3.311|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694047|NCT01065454|3115342|Superiority or Other (legacy)||LS-MEANS Difference|-0.01|||||2-Sided|95.0|-0.02|0.01|||||||
1693949|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.66||||0.7128|2-Sided|95.0|0.072|6.025|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693950|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.126||||0.0575|2-Sided|95.0|0.015|1.068|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693951|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.855||||0.014|2-Sided|95.0|1.133|3.037|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693952|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.136||||0.0008|2-Sided|95.0|1.054|1.224|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m^2. The logistic regression analysis for relapse was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693953|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.33||||0.549|2-Sided|95.0|0.523|3.38|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693954|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.389||||0.0429|2-Sided|95.0|0.156|0.97|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693955|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.108|||<|0.0001|2-Sided|95.0|0.037|0.311|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693956|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.142|||<|0.6524|2-Sided|95.0|0.641|2.035|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10**9/L at BL (>=140 - < 180 vs >=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693957|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|2.974|||<|0.002|2-Sided|95.0|1.488|5.942|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10**9/L at BL (< 140 vs >=180). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693958|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.59|||<|0.0092|2-Sided|95.0|1.122|2.254|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693959|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.266|||<|0.0182|2-Sided|95.0|1.041|1.541|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693960|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.895|||<|0.0001|2-Sided|95.0|0.846|0.948|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693961|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.364|||<|0.0645|2-Sided|95.0|0.125|1.063|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693962|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.155|||<|0.0031|2-Sided|95.0|0.045|0.533|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693963|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.15|||<|0.0095|2-Sided|95.0|1.035|1.277|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693964|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.996|||<|0.0033|2-Sided|95.0|1.259|3.165|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693965|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.895|||<|0.0001|2-Sided|95.0|0.846|0.948|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693966|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.364|||<|0.0645|2-Sided|95.0|0.125|1.063|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (not assessed/missing vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693967|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.155|||<|0.0031|2-Sided|95.0|0.045|0.533|||Regression, Logistic|||The statistical analysis is presented for liver fibrosis (no cirrhosis vs cirrhosis). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693968|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.15|||<|0.0095|2-Sided|95.0|1.035|1.277|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693969|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.996|||<|0.0033|2-Sided|95.0|1.259|3.165|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693970|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.897|||<|0.0001|2-Sided|95.0|0.852|0.945|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693971|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.267|||<|0.0846|2-Sided|95.0|0.06|1.197|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10**9/L at BL (>=140 - < 180 vs >=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693972|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|2.175|||<|0.0956|2-Sided|95.0|0.872|5.424|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10**9/L at BL (< 140 vs >=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693973|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.907|||<|0.0122|2-Sided|95.0|1.151|3.158|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693974|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.145|||<|0.0005|2-Sided|95.0|1.061|1.236|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693975|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.723|||<|0.0306|2-Sided|95.0|0.538|0.97|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693976|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.903|||<|0.0002|2-Sided|95.0|0.856|0.953|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693977|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.788|||<|0.0213|2-Sided|95.0|1.091|2.932|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693978|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.163|||<|0.0001|2-Sided|95.0|1.078|1.256|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m^2. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694048|NCT01065454|3115342|Superiority or Other (legacy)||LS-MEANS Difference|-0.01|||||2-Sided|95.0|-0.02|0.0|||||||
1694049|NCT01065454|3115342|Superiority or Other (legacy)||LS-MEANS Difference|0.0|||||2-Sided|95.0|-0.01|0.01|||||||
1693979|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.945|||<|0.0001|2-Sided|95.0|0.931|0.96|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693980|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.372|||<|0.2769|2-Sided|95.0|0.776|2.428|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10**9/L at BL (>=140 - < 180 vs >=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693981|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|3.398|||<|0.0004|2-Sided|95.0|1.722|6.706|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10**9/L at BL (< 140 vs >=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693982|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|2.124|||<|0.0386|2-Sided|95.0|1.04|4.338|||Regression, Logistic|||The statistical analysis is presented for mode of infection (other vs injection drug U). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693983|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.864|||<|0.0004|2-Sided|95.0|1.322|2.628|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693984|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.743|||<|0.002|2-Sided|95.0|0.615|0.897|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693985|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|0.943|||<|0.0001|2-Sided|95.0|0.929|0.958|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693986|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.305|||<|0.3611|2-Sided|95.0|0.737|2.312|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10**9/L at BL (>=140 - < 180 vs >=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693987|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|3.337|||<|0.0007|2-Sided|95.0|1.661|6.705|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10**9/L at BL (< 140 vs >=180). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693988|NCT01066793|3115233|Superiority or Other||Odds Ratio (OR)|1.957|||<|0.0002|2-Sided|95.0|1.383|2.77|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for relapse was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693989|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|8.247||||0.0087|2-Sided|95.0|1.704|39.908|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1693990|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|42.395|||<|0.0001|2-Sided|95.0|8.724|206.02|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1693991|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|40.88|||<|0.0001|2-Sided|95.0|7.474|223.61|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1693992|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.198|||<|0.0279|2-Sided|95.0|0.047|0.839|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1693993|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.715|||<|0.0418|2-Sided|95.0|0.517|0.988|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1693994|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.602|||<|0.6004|2-Sided|95.0|0.09|4.014|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693995|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|4.734|||<|0.0421|2-Sided|95.0|1.057|21.203|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693996|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|6.658|||<|0.0096|2-Sided|95.0|1.586|27.946|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693997|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.729|||<|0.0264|2-Sided|95.0|0.552|0.964|||Regression, Logistic|||The statistical analysis is presented for age per 10 years. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693998|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|2.352|||<|0.3478|2-Sided|95.0|0.394|14.031|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1693999|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|4.386|||<|0.0733|2-Sided|95.0|0.87|22.114|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694000|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|16.537|||<|0.0003|2-Sided|95.0|3.654|74.849|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (RVR vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a|
1694001|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.553|||<|0.002|2-Sided|95.0|0.379|0.805|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694002|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.908|||<|0.0037|2-Sided|95.0|0.851|0.969|||Regression, Logistic|||The statistical analysis is presented for BMI in kg/m^2. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694003|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|2.519|||<|0.0089|2-Sided|95.0|1.26|5.034|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (pEVR [Partial Early Virological Response] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694004|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|8.569|||<|0.0001|2-Sided|95.0|4.408|16.658|||Regression, Logistic|||The statistical analysis is presented for on-treatment response (cEVR [Complete Early Virological Response] vs No RVR/EVR). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694005|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|19.655|||<|0.0001|2-Sided|95.0|9.725|39.722|||Regression, Logistic|||The statistical analysis is presented for On-treatment response (Rapid Virological Response [RVR] vs No RVR/EVR [Early Virological Response]). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694006|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.853|||<|0.4634|2-Sided|95.0|0.558|1.305|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10**9/L at BL (>=140 - < 180 vs >=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694007|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.501|||<|0.0128|2-Sided|95.0|0.291|0.864|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10**9/L at BL (< 140 vs >=180). The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694008|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.535|||<|0.0168|2-Sided|95.0|0.32|0.893|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between on-treatment response and baseline factors available in at least 90% of participants, in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694009|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|1.093|||<|0.0042|2-Sided|95.0|1.029|1.162|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1694010|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|1.08|||<|0.0001|2-Sided|95.0|1.047|1.114|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1694011|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.359|||<|0.0017|2-Sided|95.0|0.189|0.679|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1694012|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.543|||<|0.0019|2-Sided|95.0|0.37|0.798|||Regression, Logistic|||The statistical analysis is presented for weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1694013|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|1.103|||<|0.0001|2-Sided|95.0|1.072|1.134|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in Weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1694014|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.133|||<|0.0184|2-Sided|95.0|0.025|0.712|||Regression, Logistic|||The statistical analysis is presented for Gamma-GT in log10 (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1694015|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.547|||<|0.0453|2-Sided|95.0|0.303|0.987|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2b.|
1694016|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|1.128|||<|0.0001|2-Sided|95.0|1.086|1.172|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694017|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.78|||<|0.0244|2-Sided|95.0|0.628|0.968|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a|
1694018|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|22.867|||<|0.0039|2-Sided|95.0|2.73|191.56|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694019|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|1.1|||<|0.0001|2-Sided|95.0|1.057|1.144|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694020|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.575|||<|0.0443|2-Sided|95.0|0.335|0.986|||Regression, Logistic|||The statistical analysis is presented for aspartate aminotransferase (AST) ratio at BL (> 1.5 vs <=1.5). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694021|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.784|||<|0.0341|2-Sided|95.0|0.626|0.982|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kg. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694022|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|1.13|||<|0.0001|2-Sided|95.0|1.087|1.174|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694023|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.619|||<|0.0085|2-Sided|95.0|0.433|0.885|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694050|NCT01065454|3115343|Superiority or Other (legacy)||LS-MEANS Difference|-517.48|||||2-Sided|95.0|-1369.48|334.53|||||||
1694051|NCT01065454|3115343|Superiority or Other (legacy)||LS-MEANS Difference|-447.26|||||2-Sided|95.0|-1212.74|318.22|||||||
1694024|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.9|||<|0.0012|2-Sided|95.0|0.844|0.959|||Regression, Logistic|||The statistical analysis is presented for body mass index (BMI) in kilogram per square meter (kg/m^2). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694025|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|7.945|||<|0.0031|2-Sided|95.0|2.013|31.359|||Regression, Logistic|||The statistical analysis is presented for cumulative PEG-IFN alfa-2a dose per 1000 ug, first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694026|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|1.094|||<|0.0001|2-Sided|95.0|1.048|1.142|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694027|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.573|||<|0.0041|2-Sided|95.0|0.392|0.838|||Regression, Logistic|||The statistical analysis is presented for HCV RNA at BL in log10 (IU/mL). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694028|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.676|||<|0.0005|2-Sided|95.0|0.542|0.844|||Regression, Logistic|||The statistical analysis is presented for Weight per 10 kilogram (kg). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694029|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|1.082|||<|0.0001|2-Sided|95.0|1.069|1.095|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694030|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.737|||<|0.1808|2-Sided|95.0|0.471|1.153|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10**9/L at BL (>=140 - < 180 vs >=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694031|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.464|||<|0.0079|2-Sided|95.0|0.264|0.818|||Regression, Logistic|||The statistical analysis is presented for Platelets x 10**9/L at BL (< 140 vs >=180). The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including total cumulative dose of peginterferon and ribavirin), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694032|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|1.22|||<|0.0053|2-Sided|95.0|1.061|1.403|||Regression, Logistic|||The statistical analysis is presented for cumulative ribavirin dose per 10000 mg, during the first 12 weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694033|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|1.078|||<|0.0001|2-Sided|95.0|1.065|1.092|||Regression, Logistic|||The statistical analysis is presented for treatment duration after VR in weeks. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Wk 12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694034|NCT01066793|3115247|Superiority or Other||Odds Ratio (OR)|0.527|||<|0.0211|2-Sided|95.0|0.306|0.908|||Regression, Logistic|||The statistical analysis is presented for Gamma-Glutamyl Transferase (Gamma-GT) in log10 international units per liter (IU/L) at BL. The logistic regression analysis for mSVR was performed for association between treatment exposure and baseline factors available in at least 90% of participants (including cumulative dose of peginterferon and ribavirin up to Week [Wk]12), in naive HCV mono-infected mTRT participants receiving PEG-IFN alfa-2a.|
1694035|NCT01065597|3115329|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1694036|NCT01065597|3115331|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|This was a paired t-test.|||
1694037|NCT01065597|3115332|Superiority or Other|||||||0.001|||||||t-test, 2 sided|This was a paired t-test.|||
1694038|NCT01065571|3115333|Superiority|||||||0.02||||||not adjusted for muliple comparisons, a priori threshold of 0.05|t-test, 2 sided|||paired t-test comparing baseline and value at end of participation|
1694039|NCT01065571|3115334|Superiority|fecal calprotectin (micrograms/gm stool)||||||0.06|||||||t-test, 2 sided||||
1694040|NCT01065571|3115335|Equivalence|Non-parametric analysis of interval to relapse||||||0.046||||||result from log rank test|Log Rank|||Kaplan-Meier life table analysis was performed to compare the two groups. The null hypothesis was that there would be no difference in relapses between the two groups during the study.|
1694041|NCT01065454|3115340|Superiority or Other (legacy)||LS-MEANS Difference|-18.27|||||2-Sided|95.0|-41.53|5.0|||||||
1694042|NCT01065454|3115340|Superiority or Other (legacy)||LS-MEANS Difference|-12.73|||||2-Sided|95.0|-32.89|7.43|||||||
1694043|NCT01065454|3115340|Superiority or Other (legacy)||LS-MEANSA Difference|-14.13|||||2-Sided|95.0|-30.79|2.53|||||||
1694044|NCT01065454|3115341|Superiority or Other (legacy)||LS-MEANS Difference|-0.02|||||2-Sided|95.0|-0.07|0.03|||||||
1694064|NCT01065454|3115348|Superiority or Other (legacy)||Risk Difference (RD)|0.62|||||2-Sided|95.0|-13.36|14.61|||||||
1694065|NCT01065454|3115350|Superiority or Other (legacy)||LS-MEANS Difference|-6.15|||||2-Sided|95.0|-44.08|31.78|||||||
1694066|NCT01065454|3115350|Superiority or Other (legacy)||LS-MEANS Difference|7.92|||||2-Sided|95.0|-26.76|42.59|||||||
1694067|NCT01065454|3115350|Superiority or Other (legacy)||LS-MEANS Difference|10.17|||||2-Sided|95.0|-18.48|38.81|||||||
1694068|NCT01065454|3115351|Superiority or Other (legacy)||LS-MEANS Difference|0.06|||||2-Sided|95.0|-0.45|0.56|||||||
1694069|NCT01065454|3115351|Superiority or Other (legacy)||LS-MEANS Difference|0.17|||||2-Sided|95.0|-0.34|0.67|||||||
1694070|NCT01065454|3115351|Superiority or Other (legacy)||LS-MEANS Difference|-0.15|||||2-Sided|95.0|-0.55|0.24|||||||
1694071|NCT01065454|3115352|Superiority or Other (legacy)||LS-MEANS Difference|10.35|||||2-Sided|95.0|-6.14|26.84|||||||
1694072|NCT01065454|3115352|Superiority or Other (legacy)||LS-MEANS Difference|6.47|||||2-Sided|95.0|-9.79|22.73|||||||
1694073|NCT01065454|3115352|Superiority or Other (legacy)||LS-MEANS Difference|5.29|||||2-Sided|95.0|-7.38|17.95|||||||
1694074|NCT01065454|3115353|Superiority or Other (legacy)||LS-MEANS Difference|-4.61|||||2-Sided|95.0|-26.43|17.2|||||||
1694075|NCT01065454|3115353|Superiority or Other (legacy)||LS-MEANS Difference|2.78|||||2-Sided|95.0|-17.59|23.16|||||||
1694076|NCT01065454|3115353|Superiority or Other (legacy)||LS_MEANS Difference|-4.27|||||2-Sided|95.0|-21.13|12.6|||||||
1694077|NCT01065454|3115354|Superiority or Other (legacy)||LS-MEANS Difference|-5.18|||||2-Sided|95.0|-21.05|10.69|||||||
1694078|NCT01065454|3115354|Superiority or Other (legacy)||LS-MEANS Difference|0.28|||||2-Sided|95.0|-14.55|15.11|||||||
1694079|NCT01065454|3115354|Superiority or Other (legacy)||LS-MEANS Difference|-5.06|||||2-Sided|95.0|-17.33|7.22|||||||
1694080|NCT01065454|3115355|Superiority or Other (legacy)||LS-MEANS Difference|0.2|||||2-Sided|95.0|-0.74|1.15|||||||
1694081|NCT01065454|3115355|Superiority or Other (legacy)||LS_MEANS Difference|0.81|||||2-Sided|95.0|-0.07|1.69|||||||
1694082|NCT01065454|3115355|Superiority or Other (legacy)||LS-MEANS Difference|0.51|||||2-Sided|95.0|-0.21|1.24|||||||
1694083|NCT01065454|3115356|Superiority or Other (legacy)||LS-MEANS Difference|-2.43|||||2-Sided|95.0|-8.93|4.06|||||||
1694084|NCT01065454|3115356|Superiority or Other (legacy)||LS-MEANs Difference|-0.02|||||2-Sided|95.0|-6.05|6.01|||||||
1694085|NCT01065454|3115356|Superiority or Other (legacy)||LS-MEANS Difference|-3.84|||||2-Sided|95.0|-8.76|1.09|||||||
1694086|NCT01065454|3115357|Superiority or Other (legacy)||LS-MEANS Difference|-0.03|||||2-Sided|95.0|-1.11|1.06|||||||
1694087|NCT01065454|3115357|Superiority or Other (legacy)||LS-MEANS Difference|0.82|||||2-Sided|95.0|-0.23|1.87|||||||
1694088|NCT01065454|3115357|Superiority or Other (legacy)||LS-MEANS Difference|0.28|||||2-Sided|95.0|-0.58|1.14|||||||
1694089|NCT01065454|3115358|Superiority or Other (legacy)||LS_MEANS Difference|-1.13|||||2-Sided|95.0|-4.9|2.7|||||||
1694090|NCT01065454|3115358|Superiority or Other (legacy)||LS_MEANS|1.39|||||2-Sided|95.0|-2.1|4.9|||||||
1694091|NCT01065454|3115358|Superiority or Other (legacy)||LSS-MEANS Difference|-2.07|||||2-Sided|95.0|-5.0|0.8|||||||
1694092|NCT01065454|3115359|Superiority or Other (legacy)||LS-MEANS Difference|-0.84|||||2-Sided|95.0|-3.2|1.5|||||||
1694093|NCT01065454|3115359|Superiority or Other (legacy)||LS-MEANS Difference|-0.88|||||2-Sided|95.0|-3.1|1.3|||||||
1694094|NCT01065454|3115359|Superiority or Other (legacy)||LS-MEANS Difference|-1.27|||||2-Sided|95.0|-3.1|0.5|||||||
1694095|NCT01065454|3115360|Superiority or Other (legacy)||LS-MEANS Difference|-34.97|||||2-Sided|95.0|-353.7|283.7|||||||
1694096|NCT01065454|3115360|Superiority or Other (legacy)||LS-MEANS Difference|-231.57|||||2-Sided|95.0|-530.4|67.2|||||||
1694097|NCT01065454|3115360|Superiority or Other (legacy)||LS-MEANS Difference|-446.49|||||2-Sided|95.0|-687.4|-205.6|||||||
1694098|NCT01065454|3115361|Superiority or Other (legacy)||LS-MEANS Difference|-25.54|||||2-Sided|95.0|-189.3|138.2|||||||
1694099|NCT01065454|3115361|Superiority or Other (legacy)||LS-MEANS Difference|-120.89|||||2-Sided|95.0|-274.4|32.6|||||||
1694100|NCT01065454|3115361|Superiority or Other (legacy)||LS-MEANS Difference|-239.31|||||2-Sided|95.0|-363.4|-115.3|||||||
1694101|NCT01065454|3115362|Superiority or Other (legacy)||LS-MEANS Difference|-43.22|||||2-Sided|95.0|-153.7|67.1|||||||
1694102|NCT01065454|3115362|Superiority or Other (legacy)||LS-MEANS Difference|-58.22|||||2-Sided|95.0|-162.1|45.6|||||||
1694103|NCT01065454|3115362|Superiority or Other (legacy)||LS-MEANS Difference|-89.17|||||2-Sided|95.0|-172.9|5.5|||||||
1694104|NCT01065454|3115363|Superiority or Other (legacy)||LS-MEANS Difference|-26.52|||||2-Sided|95.0|-83.0|30.0|||||||
1694105|NCT01065454|3115363|Superiority or Other (legacy)||LS-MEANS Difference|-32.26|||||2-Sided|95.0|-84.9|20.4|||||||
1694106|NCT01065454|3115363|Superiority or Other (legacy)||LS-MEANS Difference|-46.59|||||2-Sided|95.0|-89.4|-3.8|||||||
1694107|NCT01065454|3115364|Superiority or Other (legacy)||LS-MEANS Difference|0.23|||||2-Sided|95.0|-3.31|3.77|||||||
1694108|NCT01065454|3115364|Superiority or Other (legacy)||LS-MEANS Difference|0.2|||||2-Sided|95.0|-3.12|3.51|||||||
1694109|NCT01065454|3115364|Superiority or Other (legacy)||LS-MEANS Difference|1.87|||||2-Sided|95.0|-0.83|4.56|||||||
1694110|NCT01065454|3115365|Superiority or Other (legacy)||LS-MEANS Difference|-1.33||||0.5442|2-Sided|95.0|-5.66|3.0||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA||||
1694111|NCT01065454|3115365|Superiority or Other (legacy)||LS-MEANS Difference|3.13||||0.2084|2-Sided|95.0|-1.76|8.02||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA||||
1694112|NCT01065454|3115365|Superiority or Other (legacy)||LS-MEANS Difference|1.8||||0.3821|2-Sided|95.0|-2.25|5.84||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA||||
1694113|NCT01065454|3115365|Superiority or Other (legacy)||LS-MEANS Difference|-4.51||||0.0278|2-Sided|95.0|-8.52|-0.5||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA||||
1696419|NCT01033942|3118860|Superiority or Other|||||||0.7314|||||||Fisher Exact||||
1694114|NCT01065454|3115365|Superiority or Other (legacy)||LSMEANS Difference|-1.38||||0.5292|2-Sided|95.0|-5.71|2.94||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA||||
1694115|NCT01065454|3115365|Superiority or Other (legacy)||LS-MEANS Difference|-2.71||||0.1044|2-Sided|95.0|-5.99|0.057||Baseline value, treatment group and region were used as fixed effects in the ANCOVA model|ANCOVA||||
1694116|NCT01065428|3115366|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1694117|NCT01065428|3115367|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1694118|NCT01065350|3115368|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.37|2-Sided|95.0|-1.6|0.6|||t-test, 2 sided|||Average change in Stroke Volume Variation (SVV) from baseline to 10 minutes post induction was compared between treatment groups.|
1694119|NCT01065350|3115368|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.44|2-Sided|95.0|-1.4|0.6|||t-test, 2 sided|||Average change in Stroke Volume Variation (SVV) from baseline to 5 minutes post induction was compared between treatment groups.|
1694120|NCT01065350|3115369|Superiority or Other||Mean Difference (Final Values)|2.6||||0.052|2-Sided|95.0|0.0|5.2|||t-test, 2 sided|||Average change in Stroke Volume Index (SVI) from baseline to 10 minutes post induction was compared between treatment groups.|
1694121|NCT01065350|3115369|Superiority or Other||Mean Difference (Final Values)|2.5||||0.027|2-Sided|95.0|0.3|4.7|||t-test, 2 sided|||Average change in Stroke Volume Index (SVI) from baseline to 5 minutes post induction was compared between treatment groups.|
1694122|NCT01065350|3115370|Superiority or Other||Mean Difference (Final Values)|4.8||||0.051|2-Sided|95.0|0.0|9.7|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.|
1694123|NCT01065350|3115370|Superiority or Other||Mean Difference (Final Values)|4.4||||0.029|2-Sided|95.0|0.5|8.4|||t-test, 2 sided|||Average change in Stroke Volume (SV) from baseline to 5 minutes post induction was compared between treatment groups.|
1694124|NCT01065350|3115371|Superiority or Other||Mean Difference (Final Values)|128.7||||0.17|2-Sided|95.0|-58.1|315.5|||t-test, 2 sided|||Average change in Total Peripheral Resistance Index (TPRI) from baseline to 10 minutes post induction was compared between treatment groups.|
1694125|NCT01065350|3115371|Superiority or Other||Mean Difference (Final Values)|182.6||||0.017|2-Sided|95.0|33.8|331.3|||t-test, 2 sided|||Average change in Total Peripheral Resistance Index (TPRI) from baseline to 5 minutes post induction was compared between treatment groups.|
1694126|NCT01065350|3115372|Superiority or Other||Mean Difference (Final Values)|86.8||||0.12|2-Sided|95.0|-21.7|195.3|||t-test, 2 sided|||Average change in Total Peripheral Resistance (TPR) from baseline to 10 minutes post induction was compared between treatment groups.|
1694127|NCT01065350|3115372|Superiority or Other||Mean Difference (Final Values)|113.6|||<|0.01|2-Sided|95.0|28.1|199.1|||t-test, 2 sided|||Average change in Total Peripheral Resistance (TPR) from baseline to 5 minutes post induction was compared between treatment groups.|
1694128|NCT01065350|3115373|Superiority or Other||Mean Difference (Final Values)|6.3||||0.013|2-Sided|95.0|1.4|11.3|||t-test, 2 sided|||Average change in Mean Arterial Pressure from baseline to 10 minutes post induction was compared between treatment groups.|
1694129|NCT01065350|3115373|Superiority or Other||Mean Difference (Final Values)|9.4|||<|0.001|2-Sided|95.0|4.8|13.9|||t-test, 2 sided|||Average change in Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.|
1694130|NCT01065350|3115374|Superiority or Other||Mean Difference (Final Values)|4.8||||0.042|2-Sided|95.0|0.2|9.5|||t-test, 2 sided|||Average change in Diastolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.|
1694131|NCT01065350|3115374|Superiority or Other||Mean Difference (Final Values)|7.1|||<|0.01|2-Sided|95.0|2.7|11.5|||t-test, 2 sided|||Average change in Diastolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.|
1694132|NCT01065350|3115375|Superiority or Other||Mean Difference (Final Values)|8.8||||0.017|2-Sided|95.0|0.2|9.5|||t-test, 2 sided|||Average change in Systolic Blood Pressure from baseline to 10 minutes post induction was compared between treatment groups.|
1694133|NCT01065350|3115375|Superiority or Other||Mean Difference (Final Values)|13.7|||<|0.001|2-Sided|95.0|7.5|20.0|||t-test, 2 sided|||Average change in Systolic Blood Pressure from baseline to 5 minutes post induction was compared between treatment groups.|
1694134|NCT01065350|3115376|Superiority or Other||Mean Difference (Final Values)|-1.8||||0.22|2-Sided|95.0|-4.8|1.1|||t-test, 2 sided|||Average heart rate from baseline to 10 minutes post induction was compared between treatment groups.|
1694135|NCT01065350|3115376|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.61|2-Sided|95.0|-2.9|1.7|||t-test, 2 sided|||Average heart rate from baseline to 5 minutes post induction was compared between treatment groups.|
1694136|NCT01065350|3115377|Superiority or Other||Mean Difference (Final Values)|0.0||||0.71|2-Sided|95.0|-0.2|0.3|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 10 minutes post induction was compared between treatment groups.|
1694137|NCT01065350|3115377|Superiority or Other||Mean Difference (Final Values)|0.1||||0.26|2-Sided|95.0|-0.1|0.3|||t-test, 2 sided|||Average change in Cardiac Index (CI) from baseline to 5 minutes post induction was compared between treatment groups.|
1694138|NCT01065350|3115378|Superiority or Other||Mean Difference (Final Values)|0.1||||0.6|2-Sided|95.0|-0.3|0.5|||t-test, 2 sided|||Average change in Cardiac Output (CO) from baseline to 10 minutes post induction was compared between treatment groups.|
1694139|NCT01065350|3115378|Superiority or Other||Mean Difference (Final Values)|0.2||||0.19|2-Sided|95.0|-0.1|0.5|||t-test, 2 sided|||Average change in Cardiac Output (CO) from baseline to 5 minutes post induction was compared between treatment groups.|
1694140|NCT01065350|3115379|Superiority or Other||Odds Ratio (OR)|1.71||||0.33|2-Sided|95.0|0.51|5.97||A p value of < 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 30 minutes post induction was compared between treatment groups.|
1694141|NCT01065350|3115379|Superiority or Other||Odds Ratio (OR)|2.84||||0.02|2-Sided|95.0|1.07|7.65||A p value of < 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 10 minutes post induction was compared between treatment groups.|
1694142|NCT01065350|3115379|Superiority or Other||Odds Ratio (OR)|7.12|||<|0.001|2-Sided|95.0|1.98|31.64||A p value of < 0.05 was considered to indicate statistical significance.|Chi-squared|||Mean Arterial Pressure (MAP) from baseline to 5 minutes post induction was compared between treatment groups.|
1694143|NCT01065350|3115380|Superiority or Other||Odds Ratio (OR)|2.74||||0.11|2-Sided|95.0|0.68|13.19||A p value of < 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 30 minutes post induction was compared between treatment groups.|
1694144|NCT01065350|3115380|Superiority or Other||Odds Ratio (OR)|2.38||||0.05|2-Sided|95.0|0.91|6.29||A p value of < 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 10 minutes post induction was compared between treatment groups.|
1694145|NCT01065350|3115380|Superiority or Other||Odds Ratio (OR)|4.64|||<|0.01|2-Sided|95.0|1.54|14.92||A p value of < 0.05 was considered to indicate statistical significance.|Chi-squared|||Diastolic Blood Pressure (DBP) from baseline to 5 minutes post induction was compared between treatment groups.|
1694146|NCT01065350|3115381|Superiority or Other||Odds Ratio (OR)|1.53||||0.39|2-Sided|95.0|0.52|4.55||A p value of < 0.005 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 30 minutes post induction was compared between treatment groups|
1694147|NCT01065350|3115381|Superiority or Other||Odds Ratio (OR)|3.24|||<|0.01|2-Sided|95.0|1.21|8.75||A p value of < 0.05 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 10 minutes post induction was compared between treatment groups.|
1694148|NCT01065350|3115381|Superiority or Other||Odds Ratio (OR)|6.87|||<|0.001|2-Sided|95.0|2.07|26.15||A p value of < 0.05 was considered to indicate statistical significance.|Chi-squared|||Systolic Blood Pressure (SBP) from baseline to 5 minutes post induction was compared between treatment groups.|
1694149|NCT01064856|3115412|Superiority or Other|||||||0.051|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.|||
1694150|NCT01064856|3115413|Superiority or Other|||||||0.003|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.|||
1694151|NCT01064856|3115414|Superiority or Other||||||<|0.001|||||||ANCOVA|The P-value was based on an ANCOVA model adjusting for baseline with treatment as a factor.|||
1694152|NCT01064856|3115416|Superiority or Other|||||||0.006|||||||Pearson's chi-square||||
1694153|NCT01064687|3115486|Superiority or Other||LS Mean Difference|-1.75||||0.638|2-Sided|95.0|-9.05|5.55||Treatment comparison of HOMA2-S|Mixed Models Analysis||||
1694154|NCT01064687|3115486|Superiority or Other||LS Mean Difference|-3.73||||0.307|2-Sided|95.0|-10.9|3.43||Treatment comparison of HOMA2-S|Mixed Models Analysis||||
1694155|NCT01064687|3115486|Superiority or Other||LS Mean Difference|12.12|||<|0.001|2-Sided|95.0|5.56|18.68||Treatment comparison of HOMA2-B|Mixed Models Analysis||||
1694156|NCT01064687|3115486|Superiority or Other||LS Mean Difference|21.64|||<|0.001|2-Sided|95.0|15.2|28.08||Treatment comparison of HOMA2-B|Mixed Models Analysis||||
1694157|NCT01064687|3115487|Superiority or Other||LS Mean Difference|-4.15||||0.362|2-Sided|95.0|-13.1|4.79||Treatment comparison of HOMA2-S|Mixed Models Analysis||||
1694158|NCT01064687|3115487|Superiority or Other||LS Mean Difference|2.75||||0.441|2-Sided|95.0|-4.25|9.76||Treatment comparison of HOMA2-S|Mixed Models Analysis||||
1694159|NCT01064687|3115487|Superiority or Other||LS Mean Difference|-1.4||||0.759|2-Sided|95.0|-10.37|7.56||Treatment comparison of HOMA2-S|Mixed Models Analysis||||
1694160|NCT01064687|3115487|Superiority or Other||LS Mean Difference|-1.54||||0.659|2-Sided|95.0|-8.41|5.32||Treatment comparison of HOMA2-S|Mixed Models Analysis||||
1694161|NCT01064687|3115487|Superiority or Other||LS Mean Difference|-5.7||||0.207|2-Sided|95.0|-14.56|3.17||Treatment comparison of HOMA2-S|Mixed Models Analysis||||
1694162|NCT01064687|3115487|Superiority or Other||LS Mean Difference|14.09|||<|0.001|2-Sided|95.0|6.06|22.11||Treatment comparison of HOMA2-B|Mixed Models Analysis||||
1694163|NCT01064687|3115487|Superiority or Other||LS Mean Difference|8.59|||<|0.007|2-Sided|95.0|2.31|14.87||Treatment comparison of HOMA2-B|Mixed Models Analysis||||
1694164|NCT01064687|3115487|Superiority or Other||LS Mean Difference|22.68|||<|0.001|2-Sided|95.0|14.63|30.72||Treatment comparison of HOMA2-B|Mixed Models Analysis||||
1694165|NCT01064687|3115487|Superiority or Other||LS Mean Difference|21.12|||<|0.001|2-Sided|95.0|14.97|27.28||Treatment comparison of HOMA2-B|Mixed Models Analysis||||
1694166|NCT01064687|3115487|Superiority or Other||LS Mean Difference|35.21|||<|0.001|2-Sided|95.0|27.26|43.16||Treatment comparison of HOMA2-B|Mixed Models Analysis||||
1694167|NCT01064687|3115488|Superiority or Other||Odds Ratio (OR)|2.1|||<|0.001|2-Sided|95.0|1.4|3.1||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic||||
1694168|NCT01064687|3115488|Superiority or Other||Odds Ratio (OR)|3.5|||<|0.001|2-Sided|95.0|2.3|5.1||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic||||
1694169|NCT01064687|3115488|Superiority or Other||Odds Ratio (OR)|1.7|||<|0.008|2-Sided|95.0|1.1|2.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic||||
1694170|NCT01064687|3115488|Superiority or Other||Odds Ratio (OR)|3.7|||<|0.001|2-Sided|95.0|2.4|5.6||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic||||
1694171|NCT01064687|3115489|Superiority or Other||Odds Ratio (OR)|2.7|||<|0.001|2-Sided|95.0|1.6|4.6||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic||||
1694172|NCT01064687|3115489|Superiority or Other||Odds Ratio (OR)|2.4|||<|0.001|2-Sided|95.0|1.6|3.5||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic||||
1694173|NCT01064687|3115489|Superiority or Other||Odds Ratio (OR)|6.3|||<|0.001|2-Sided|95.0|3.7|10.9||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic||||
1694174|NCT01064687|3115489|Superiority or Other||Odds Ratio (OR)|4.4|||<|0.001|2-Sided|95.0|2.9|6.8||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic||||
1694175|NCT01064687|3115489|Superiority or Other||Odds Ratio (OR)|11.8|||<|0.001|2-Sided|95.0|6.7|20.8||Treatment comparison for HbA1c less than or equal to 6.5%.|Regression, Logistic||||
1694176|NCT01064687|3115489|Superiority or Other||Odds Ratio (OR)|2.1|||<|0.004|2-Sided|95.0|1.3|3.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic||||
1694177|NCT01064687|3115489|Superiority or Other||Odds Ratio (OR)|2.3|||<|0.001|2-Sided|95.0|1.5|3.5||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic||||
1694178|NCT01064687|3115489|Superiority or Other||Odds Ratio (OR)|4.8|||<|0.001|2-Sided|95.0|2.8|8.0||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic||||
1694179|NCT01064687|3115489|Superiority or Other||Odds Ratio (OR)|6.2|||<|0.001|2-Sided|95.0|3.9|10.1||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic||||
1694180|NCT01064687|3115489|Superiority or Other||Odds Ratio (OR)|13.1|||<|0.001|2-Sided|95.0|7.4|23.4||Treatment comparison for HbA1c less than 7.0%.|Regression, Logistic||||
1694181|NCT01064687|3115490|Superiority or Other||LS Mean Difference|-4.47||||0.092|2-Sided|95.0|-9.66|0.73|||Mixed Models Analysis||||
1694182|NCT01064687|3115490|Superiority or Other||LS Mean Difference|-7.68||||0.004|2-Sided|95.0|-12.84|-2.52|||Mixed Models Analysis||||
1694183|NCT01064687|3115491|Superiority or Other||LS Mean Difference|-19.41|||<|0.001|2-Sided|95.0|-25.18|-13.65|||Mixed Models Analysis||||
1694184|NCT01064687|3115491|Superiority or Other||LS Mean Difference|-4.61|||<|0.038|2-Sided|95.0|-8.95|-0.27|||Mixed Models Analysis||||
1694185|NCT01064687|3115491|Superiority or Other||LS Mean Difference|-24.02|||<|0.001|2-Sided|95.0|-29.8|-18.24|||Mixed Models Analysis||||
1694186|NCT01064687|3115491|Superiority or Other||LS Mean Difference|-9.34|||<|0.001|2-Sided|95.0|-13.62|-5.06|||Mixed Models Analysis||||
1694187|NCT01064687|3115491|Superiority or Other||LS Mean Difference|-28.76|||<|0.001|2-Sided|95.0|-34.5|-23.02|||Mixed Models Analysis||||
1694188|NCT01064687|3115492|Superiority or Other||LS Mean Difference|0.46||||0.005|2-Sided|95.0|0.14|0.79|||Mixed Models Analysis||||
1694189|NCT01064687|3115492|Superiority or Other||LS Mean Difference|-0.09||||0.58|2-Sided|95.0|-0.42|0.23|||Mixed Models Analysis||||
1694190|NCT01064687|3115493|Superiority or Other||LS Mean Difference|-0.9|||<|0.001|2-Sided|95.0|-1.2|-0.6|||Mixed Models Analysis||||
1694191|NCT01064687|3115493|Superiority or Other||LS Mean Difference|0.48|||<|0.001|2-Sided|95.0|0.24|0.71|||Mixed Models Analysis||||
1694192|NCT01064687|3115493|Superiority or Other||LS Mean Difference|-0.42|||<|0.006|2-Sided|95.0|-0.72|-0.12|||Mixed Models Analysis||||
1694193|NCT01064687|3115493|Superiority or Other||LS Mean Difference|-0.07|||<|0.568|2-Sided|95.0|-0.31|0.17|||Mixed Models Analysis||||
1694194|NCT01064687|3115493|Superiority or Other||LS Means Difference|-0.97|||<|0.001|2-Sided|95.0|-1.27|-0.67|||Mixed Models Analysis||||
1694195|NCT01064687|3115494|Superiority or Other||LS Mean Difference|1.25||||0.009|2-Sided|95.0|0.32|2.19|||Mixed Models Analysis||||
1694196|NCT01064687|3115494|Superiority or Other||LS Mean Difference|-0.32||||0.507|2-Sided|95.0|-1.25|0.62|||Mixed Models Analysis||||
1694197|NCT01064687|3115495|Superiority or Other||LS Mean Difference|-2.52|||<|0.001|2-Sided|95.0|-3.39|-1.65|||Mixed Models Analysis||||
1694198|NCT01064687|3115495|Superiority or Other||LS Mean Difference|1.33|||<|0.001|2-Sided|95.0|0.64|2.01|||Mixed Models Analysis||||
1694199|NCT01064687|3115495|Superiority or Other||LS Mean Difference|-1.19|||<|0.007|2-Sided|95.0|-2.06|-0.33|||Mixed Models Analysis||||
1694200|NCT01064687|3115495|Superiority or Other||LS Mean Difference|-0.2|||<|0.571|2-Sided|95.0|-0.88|0.49|||Mixed Models Analysis||||
1694201|NCT01064687|3115495|Superiority or Other||LS Mean Difference|-2.72|||<|0.001|2-Sided|95.0|-3.58|-1.85|||Mixed Models Analysis||||
1694202|NCT01064687|3115496|Superiority or Other||LS Mean Difference|-0.27|||<|0.001|2-Sided|95.0|-0.44|-0.11||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.|
1694203|NCT01064687|3115496|Superiority or Other||LS Mean Difference|-0.56|||<|0.001|2-Sided|95.0|-0.73|-0.39||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.|
1694204|NCT01064687|3115496|Non-Inferiority or Equivalence|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.27|||<|0.001|2-Sided|95.0|-0.44|-0.11||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.|
1694205|NCT01064687|3115496|Non-Inferiority or Equivalence|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.56|||<|0.001|2-Sided|95.0|-0.73|-0.39||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.|
1694206|NCT01064687|3115497|Superiority or Other||LS Mean Difference|-0.31|||<|0.001|2-Sided|95.0|-0.44|-0.18||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.|
1694207|NCT01064687|3115497|Non-Inferiority or Equivalence|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.31|||<|0.001|2-Sided|95.0|-0.44|-0.18||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.|
1694208|NCT01064687|3115497|Superiority or Other||LS Mean Difference|-0.52|||<|0.001|2-Sided|95.0|-0.66|-0.39||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.|
1694209|NCT01064687|3115497|Superiority or Other||LS Mean Difference|-0.84|||<|0.001|2-Sided|95.0|-1.01|-0.67||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.|
1694210|NCT01064687|3115497|Non-Inferiority or Equivalence|A non-inferiority margin of 0.4% was used.|LS Mean Difference|-0.52|||<|0.0001|2-Sided|95.0|-0.66|-0.39||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Non-inferiority analysis.|
1694211|NCT01064687|3115497|Superiority or Other||LS Mean Difference|-1.05|||<|0.001|2-Sided|95.0|-1.22|-0.88||P-value is adjusted for multiplicity based on a tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis.|
1694212|NCT01064648|3115500|Other||Odds Ratio (OR)|0.59||||0.19|2-Sided|95.0|0.18|1.94||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology|||
1694213|NCT01064648|3115501|Other||Odds Ratio (OR)|4.3||||0.006|2-Sided|95.0|1.4|13.3||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology.|||
1694214|NCT01064648|3115502|Other||Odds Ratio (OR)|0.45||||0.09|2-Sided|95.0|0.14|1.49||1-sided p-value|Chi-squared|Stratified Chi-Square by performance status and histology|||
1694215|NCT01064648|3115503|Other||Odds Ratio (OR)|1.85||||0.15|2-Sided|95.0|0.59|5.83||1-sided p-value|Chi-squared|Stratified Chi-square by performance status and histology.|||
1694216|NCT01064648|3115504|Other||Hazard Ratio (HR)|0.88||||0.28|2-Sided|80.0|0.65|1.17||1-sided p-value|Log Rank|Stratified log-rank test by performance status and histology.|||
1694217|NCT01064648|3115505|Other||Hazard Ratio (HR)|0.71||||0.06|2-Sided|80.0|0.54|0.95||1-sided p-value|Log Rank|Stratified log rank test by performance status and histology type.|||
1694218|NCT01064622|3115509|Superiority or Other|||||||0.42||||||Two-sided p-value for Cochran-Mantel-Haenszel test stratified by Karnofsky performance status and disease status.|Cochran-Mantel-Haenszel||||
1694219|NCT01064622|3115510|Superiority or Other||Hazard Ratio (HR)|0.96||||0.37|2-Sided|95.0|0.64|1.46|||Log Rank|Stratified by Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|Hazard ratio is for (gemcitabine hydrochloride plus vismodegib)/(gemcitabine hydrochloride plus placebo), adjusted for Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)||
1694220|NCT01064622|3115511|Superiority or Other||Hazard Ratio (HR)|0.82||||0.15|2-Sided|95.0|0.55|1.22||Reported p-value is one-sided. p<0.10 required for statistical significance.|Log Rank|Stratified by Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)|Hazard ratio is for (gemcitabine hydrochloride plus vismodegib)/(gemcitabine hydrochloride plus placebo), adjusted for Karnofsky performance status (90-100 vs. 80) and disease status (newly diagnosed vs. recurrent after surgery)||
1694221|NCT01064414|3115532|Superiority or Other||Least-Squares Mean Difference|-12.2|Standard Error of the Mean|6.683||0.069|2-Sided|95.0|-25.36|0.962|||ANCOVA||||
1694222|NCT01064414|3115532|Superiority or Other||Least-Squares Mean Difference|-15.4|Standard Error of the Mean|6.638||0.021|2-Sided|95.0|-28.45|-2.307|||ANCOVA||||
1694223|NCT01064414|3115533|Superiority or Other||Odds Ratio (OR)|2.69||||0.017|2-Sided|95.0|1.19|6.04|||Regression, Logistic||||
1694224|NCT01064414|3115533|Superiority or Other||Odds Ratio (OR)|1.66||||0.227|2-Sided|95.0|0.73|3.77|||Regression, Logistic||||
1694225|NCT01064414|3115534|Superiority or Other||Least-Squares Mean Difference|-0.4|Standard Error of the Mean|0.117|<|0.001|2-Sided|95.0|-0.635|-0.174|||ANCOVA||||
1694226|NCT01064414|3115534|Superiority or Other||Least-Squares Mean Difference|-0.3|Standard Error of the Mean|0.117|<|0.012|2-Sided|95.0|-0.529|-0.066|||ANCOVA||||
1694227|NCT01064401|3115535|Superiority or Other||Percent Reduction in Odds of Worsening|24.2|||||2-Sided|95.0|4.7|39.6|||||||
1694228|NCT01064401|3115535|Superiority or Other||Odds Ratio (OR)|0.76||||0.0176|2-Sided|95.0|0.6|0.95||Based on logistic regression model, adjusted for baseline MSIS-29 physical score, baseline Beck Depression Inventory (BDI) score, history of prior IFN beta use, and baseline age (≤ 35 vs > 35 years).|Regression, Logistic||||
1694229|NCT01064401|3115536|Superiority or Other||Percent Reduction in Risk of Relapse|40.9|||||2-Sided|95.0|30.8|49.5|||||||
1694230|NCT01064401|3115536|Superiority or Other||Cox Proportional Hazard|0.59|||<|0.0001|2-Sided|95.0|0.5|0.69||Based on Cox proportional hazards model, adjusted for baseline relapse rate, history of prior IFN beta use, baseline EDSS (EDSS ≤ 2.5 vs EDSS > 2.5) and baseline age (≤ 35 vs > 35 years).|Cox Proportional Hazard||||
1694231|NCT01064401|3115537|Superiority or Other||Percent Reduction|16.1|||||2-Sided|95.0|-7.0|34.2|||||||
1694232|NCT01064401|3115537|Superiority or Other||Cox Proportional Hazard|0.84||||0.1575|2-Sided|95.0|0.66|1.07||Based on Cox Proportional Hazards model, adjusted by baseline EDSS values as continuous variable, history of prior IFN beta use, and baseline age (≤ 35 vs > 35 years).|Cox Proportional Hazard||||
1694233|NCT01064401|3115538|Superiority or Other||Percent Reduction|54.4|||<|0.0001|2-Sided|95.0|46.9|60.8||Estimated from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs > 35 years).|Negative Binomial Regression|The logarithmic transformation of the scan number of the MRI assessment was included in the model as the 'offset' parameter.|||
1694234|NCT01064401|3115539|Superiority or Other||Percent Reduction|45.0|||||2-Sided|95.0|35.5|53.1|||||||
1694235|NCT01064401|3115539|Superiority or Other||Rate Ratio|0.55|||<|0.0001|2-Sided|95.0|0.469|0.645||Estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline EDSS (≤ 2.5 vs > 2.5) and baseline age (≤ 35 vs > 35 years).|Negative Binomial Regression||||
1694236|NCT01064323|3115552|Other|||||||0.2|||||||t-test, 2 sided||||
1694237|NCT01064323|3115559|Other|Paired T-test to detect if there was a change from baseline to 5 minutes into intermittent pneumatic compression (IPC)||||||0.02|||||||Paired t-test||||
1694238|NCT01064310|3115571|Superiority or Other||Percentage of participants|49.26|||<|0.001|2-Sided|90.0|37.0|61.5||The p value indicates the difference in preference for pazopanib versus sunitinib treatment|Prescotts test||The estimated value indicates the difference in the percentage of participants who preferred pazopanib versus sunitinib. This difference is adjusted for sequence.||
1694297|NCT01062308|3115743|Superiority or Other||Mean difference from baseline to day 30|6.6||||0.16|2-Sided|95.0|-2.7|15.9|||Mixed Models Analysis||||
1694239|NCT01064297|3115575|Superiority or Other||Wilson Score with Continuity Correction|2.8||||||95.0|1.6|4.9|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).||
1694240|NCT01064297|3115575|Superiority or Other||Wilson Score with Continuity Correction|2.8||||||95.0|1.5|5.0|||||||
1694241|NCT01064297|3115576|Superiority or Other||Wilson Score with Continuity Correction|9.3||||||95.0|5.5|15.2|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).||
1694242|NCT01064297|3115576|Superiority or Other||Wilson Score with Continuity Correction|10.7||||||95.0|6.4|17.0|||||||
1694243|NCT01064297|3115577|Superiority or Other||Wilson Score with Continuity Correction|2.4||||||95.0|1.7|3.3|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).||
1694244|NCT01064297|3115577|Superiority or Other||Wilson Score with Continuity Correction|4.2||||||95.0|1.4|11.0|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).||
1694245|NCT01064297|3115577|Superiority or Other||Wilson Score with Continuity Correction|2.2||||||95.0|1.6|3.1|||||The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).||
1694246|NCT01064167|3115589|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1694247|NCT01064167|3115590|Superiority or Other||||||<|0.05|||||||Chi-squared|||Given that the frequency of RBC transfusion for OPCAB surgery is about 55%, to detect 35% reduction in TA group, with power=o.8 and α=0.05, a group of 107 patients in each arm is required. We estimated a crossover rate of 20%. The final sample size for randomization purposes increased to a total of 260 patients. The Chi-square test was used to test the differences in categorical variables between both groups.If one or more cells had an expected count less than 5, Fisher's Exact Test was used.|
1694248|NCT01063972|3115595|Superiority|||||||0.48|||||||Chi-squared||||
1694249|NCT01063972|3115596|Superiority|||||||0.56|||||||Chi-squared||||
1694250|NCT01063972|3115597|Superiority|||||||0.22|||||||Chi-squared||||
1694251|NCT01063972|3115598|Superiority|||||||0.46|||||||Chi-squared||||
1694252|NCT01063855|3115614|Superiority or Other||Odds Ratio (OR)|2.21|||<|0.001|2-Sided|95.0|1.425|3.423||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.|
1694253|NCT01063855|3115615|Superiority or Other||Odds Ratio (OR)|1.33|||>|0.05|2-Sided|95.0|0.897|1.965||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.|
1694254|NCT01063855|3115616|Superiority or Other||Odds Ratio (OR)|2.42|||<|0.001|2-Sided|95.0|1.642|3.568||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12.|
1694255|NCT01063855|3115617|Superiority or Other||Odds Ratio (OR)|1.63||||0.007|2-Sided|95.0|1.108|2.394||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carrried forward (LPOCF) Alternative Hypothesis:- PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.|
1694256|NCT01063855|3115618|Superiority or Other||Odds Ratio (OR)|1.78||||0.002|2-Sided|95.0|1.204|2.619||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error.|Regression, Logistic|Logistic Regression model included treatment, type of PDE5i stratum, baseline Average IELT stratum, and region, as factors.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm over PDE5I + Placebo arm ratio.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF) Alternative Hypothesis: PDE5I + Dapoxetine is superior to PDE5I + Placebo with respect to the outcome measure at Week 12 LPOCF.|
1694257|NCT01063855|3115619|Superiority or Other||Risk Difference (RD)|9.2||||0.013|2-Sided|95.0|1.1|17.2||A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.|Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + Placebo arm.|Null Hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF).|
1694258|NCT01063855|3115620|Superiority or Other||Risk Difference (RD)|13.6||||0.001|2-Sided|95.0|4.9|22.3||A hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type 1 error rate.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test, controlling for type of PDE5I stratum, baseline average IELT stratum, and region.|Risk Difference (RD) = PDE5I + Dapoxetine arm - PDE5I + placebo arm.|Null hypothesis: No difference at Week 12 last postbaseline observation carried forward (LPOCF). Alternative hypothesis: Difference at Week 12 LPOCF > 0.|
1694259|NCT01063855|3115621|Superiority or Other||Median Difference (Final Values)|1.69|Standard Error of the Mean|0.43|<|0.001|2-Sided|95.0|0.837|2.542||To properly adjust for multiplicity, a hierarchical (step-down) testing procedure with a priori ordered hypothesis was used to control the family-wise type I error was rate.|ANCOVA|ANCOVA model included treatment, PDE5I stratum, baseline Average IELT stratum, and region, as cofactors and baseline Average IELT as a covariate.|Estimates are based on two-stage sequential analysis using information fraction based weighted test statistics for PDE5I + Dapoxetine arm minus PDE5I + Placebo arm difference.|Null Hypothesis: No difference at Week 12 last postbaseline observations carried forward (LPOCF) Alternative Hypothesis:- Difference at Week 12 LPOCF >0.|
1694260|NCT01063829|3115622|Superiority or Other|||||||0.321|||||||Fisher Exact||||
1694261|NCT01063829|3115622|Superiority or Other|||||||0.014|||||||Fisher Exact||||
1694262|NCT01063829|3115622|Superiority or Other|||||||0.007|||||||Fisher Exact||||
1694263|NCT01063829|3115623|Superiority or Other|||||||0.148|||||||Log Rank||||
1694264|NCT01063829|3115623|Superiority or Other|||||||0.126|||||||Log Rank||||
1694265|NCT01063829|3115623|Superiority or Other|||||||0.002|||||||Log Rank||||
1694266|NCT01063829|3115624|Superiority or Other|||||||0.321|||||||Fisher Exact||||
1694267|NCT01063829|3115624|Superiority or Other|||||||0.014|||||||Fisher Exact||||
1694268|NCT01063829|3115624|Superiority or Other|||||||0.007|||||||Fisher Exact||||
1694269|NCT01063712|3115636|Superiority or Other||||||<|0.01|||||||percentage|The analysis was made on the basis of the percentage of patients with completely regressed dilation.||It is a one arm clinical study. No comparison between groups was made.|
1694270|NCT01063712|3115637|Superiority or Other||||||<|0.01|||||||percentage|||It is not a analysis of two groups. Only one group of patients was analyzed.|
1694271|NCT01063517|3115654|Superiority or Other (legacy)||Hazard Ratio (HR)|0.35|||||2-Sided|80.0|0.22|0.56|||||The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).|
1694272|NCT01063517|3115655|Superiority or Other (legacy)||Hazard Ratio (HR)|0.56|||||2-Sided|80.0|0.41|0.75|||||The numerator of the hazard ratio is hazards of death in olaparib+paclitaxel group and denominator is hazards of death in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).|
1694273|NCT01063517|3115656|Superiority or Other (legacy)||Hazard Ratio (HR)|0.74|||||2-Sided|80.0|0.51|1.08|||||The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).|
1694274|NCT01063517|3115657|Superiority or Other (legacy)||Hazard Ratio (HR)|0.8|||||2-Sided|80.0|0.62|1.03|||||The numerator of the hazard ratio is hazards of progression in olaparib+paclitaxel group and denominator is hazards of progression in placebo+paclitaxel group. Confidence intervals are calculated using the profile-likelihood method.|The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).|
1694275|NCT01062971|3115703|Non-Inferiority|Noninferiority was determined if the treatments did not show differences greater than 20%.|||||>|0.05|||||||t-test, 2 sided||||
1694276|NCT01062971|3115704|Non-Inferiority|Noninferiority was determined if the treatments did not show differences greater than 20%||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1694277|NCT01062841|3115716|Superiority or Other||Cox Proportional Hazard|0.9||||0.59|2-Sided|95.0|0.6|1.33|||Regression, Cox||||
1694278|NCT01062841|3115717|Superiority or Other||Cox Proportional Hazard|0.85||||0.61|2-Sided|95.0|0.45|1.6|||Regression, Cox|||A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual’s risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.|
1694279|NCT01062841|3115718|Superiority or Other||Cox Proportional Hazard|0.78||||0.01|2-Sided|95.0|0.65|0.95|||Regression, Cox|||A Cox proportional hazards model was used to evaluate the effect of this intervention on an individual’s risk of new MDRO acquisition, defined as the number of residents with new acquisitions per 1000 device-days at risk after adjusting for resident-level and facility-level covariates, as well as clustering by facility. Residents colonized with the specific MDRO at baseline were excluded from these analyses.|
1694280|NCT01062841|3115719|Superiority or Other||Cox Proportional Hazard|1.83||||0.34|2-Sided|95.0|0.53|6.31|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.|
1694281|NCT01062841|3115720|Superiority or Other||Cox Proportional Hazard|1.09||||0.92|2-Sided|95.0|0.22|5.45|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.|
1694298|NCT01062308|3115744|Superiority or Other||Mean difference from baseline to day 30|-11.8||||0.03|2-Sided|95.0|-22.6|-1.1|||Mixed Models Analysis||||
1694406|NCT01061333|3115824|Superiority or Other||Geom. mean of fold change over Placebo|0.99||||0.9723|2-Sided|90.0|0.72|1.37||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale|||
1694282|NCT01062841|3115722|Superiority or Other||Rate Ratio|0.75|||<|0.05|2-Sided|95.0|0.58|0.97||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.|
1694283|NCT01062841|3115723|Superiority or Other||Rate Ratio|0.94|||>|0.05|2-Sided|95.0|0.61|1.44||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.|
1694284|NCT01062841|3115724|Superiority or Other||Rate Ratio|1.2|||>|0.05|2-Sided|95.0|0.82|1.75||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.|
1694285|NCT01062841|3115725|Superiority or Other||Rate Ratio|0.78|||<|0.05|2-Sided|95.0|0.64|0.96||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.|
1694286|NCT01062841|3115726|Superiority or Other||Cox Proportional Hazard|0.54||||0.04|2-Sided|95.0|0.3|0.97|||Regression, Cox|||A Cox proportional hazards model using the cluster option with robust standard errors was used to predict time to the first and recurrent infections, adjusting for participant-level and facility-level covariates.|
1694287|NCT01062841|3115727|Superiority or Other||Rate Ratio|0.77|||<|0.05|2-Sided|95.0|0.62|0.94||The model was adjusted for participant-specific covariates (participant-level baseline colonization with the specific MDRO, age, sex, race, and length of stay before enrollment), and NH quality ratings.|Regression, Poisson|||A mixed-effects multilevel Poisson regression model was used to predict MDRO prevalence density as a function of the intervention (primary outcome), including facility as a random effect and offset by the number of anatomic sites sampled. Because we expected participants colonized at baseline to have a greater likelihood of subsequent colonization, we included participant-level baseline MDRO colonization as a fixed effect.|
1694288|NCT01062425|3115734|Superiority or Other (legacy)|||||||0.02||||||Significance level 0.05, two-sided test.|Chi-squared||||
1694289|NCT01062425|3115735|Superiority or Other (legacy)||Hazard Ratio (HR)|0.67||||0.036|2-Sided|95.0|0.46|0.97|||Regression, Cox||Placebo is the reference arm.|Multivariate analysis with the Cox proportional hazard model for progression-free survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and recursive partitioning analysis (RPA) risk class.|
1694290|NCT01062425|3115735|Superiority or Other (legacy)||Hazard Ratio (HR)|0.67||||0.03|2-Sided|95.0|0.47|0.95||Significance level 0.05, two-sided test.|Log Rank||Placebo is the reference arm for the hazard ratio.||
1694291|NCT01062425|3115736|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.648|2-Sided|95.0|0.62|1.34|||Regression, Cox||Placebo is reference level for the hazard ratio.|Multivariate analysis with the Cox proportional hazard model for overall survival was performed with the stratification variables as fixed variables to assess the treatment effect adjusting patient-specific risk factors. The covariates evaluated for the multivariate models were assigned protocol treatment, MGMT methylation status, and RPA risk class.|
1694292|NCT01062425|3115736|Superiority or Other (legacy)||Hazard Ratio (HR)|0.87||||0.44|2-Sided|95.0|0.6|1.24||Significance level 0.05, two-sided test.|Log Rank||Placebo is the reference arm for the hazard ratio.||
1694293|NCT01062425|3115737|Superiority or Other (legacy)|||||||0.005||||||One-sided test with significance level of 0.15.|Z-test|||The null hypothesis was that the 6m PFS rates for both arms are 50%, and the alternative hypothesis was that patients receiving the experimental regimen would have a 6-month PFS rate of 66%. With 150 eligible patients, there would be an 80% statistical power to detect the 16% absolute increase in 6m PFS at a significance level of 0.15, using a one-sided Z test for two proportions.|
1694294|NCT01062399|3115740|Superiority||Hazard Ratio (HR)|1.67||||0.008|2-Sided|95.0|1.14|2.45|||Log Rank|2-sided significance level = 0.05|Reference level = RT + TMZ||
1694295|NCT01062399|3115741|Superiority||Hazard Ratio (HR)|1.15||||0.79|2-Sided|95.0|0.82|1.6|||Log Rank||Reference arm = RT + TMZ|Assuming exponential distribution with median PFS (mPFS) time for control of 6.7 mos. for the control arm, tt was hypothesized that there would be a 43% improvement in mPFS time, corresponding to a mPFS time of 9.6. This is equivalent to a hazard ratio of 0.7 for the experimental arm vs. control arm. With a 1-sided significance level = 0.15 and 85% power, a total of 134 PFS events out of 180 eligible patients were required to detect the projected effect size.|
1694296|NCT01062399|3115742|Other||||||||||||||||||A dose level for RAD001 will be considered acceptable if no patient of the first 3patients or no more than 2 patients of the first 6 patients experience a DLT. If the current level is considered acceptable, then dose escalation will occur and the protocol will be reopened. Otherwise, the preceding acceptable dose level will be declared the MTD.
1694299|NCT01062269|3115746|Superiority or Other||||||<|0.05||||||Differences between test products were assessed by repeated measures analysis of variance. If sequence was not found to be statistically significant(p>0.05),then it was removed from the final model.|measures analysis of variance|Differences between test powders assessed by repeated measures analysis of variance, pairwise comparisons between treatments by Scheffe procedure.||The BASA scale components were derived from the parameters best shown to differentiate acceptability between different BAS preparations (taste and texture),as well as other parameters useful for differentiating between different BAS preparations(appearance and mixability). The scale was then weighted based upon an “Importance of Acceptability” questionnaire regarding the individual scale components. The developed scale should reasonably allow for future comparisons of differing BAS formulations.|
1694300|NCT01062256|3115748|Superiority or Other||weighted Goodman-Kruskal Gamma statistic|-0.12||||0.256|2-Sided|95.0|-0.32|0.08||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.|
1694301|NCT01062256|3115748|Superiority or Other||weighted Goodman-Kruskal Gamma statistic|-0.01||||0.949|2-Sided|95.0|-0.25|0.23||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.|
1694302|NCT01062256|3115748|Superiority or Other||Goodman-Kruskal Gamma statistic|0.15||||0.254|2-Sided|95.0|-0.09|0.39||p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site.|Cochran-Mantel-Haenszel|||Pairwise comparison of global evaluation of study medication.|
1694303|NCT01062256|3115749|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.306|2-Sided|95.0|-0.3|0.09||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose|
1694304|NCT01062256|3115749|Superiority or Other||Mean Difference (Final Values)|0.0||||0.991|2-Sided|95.0|-0.24|0.24||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose|
1694305|NCT01062256|3115749|Superiority or Other||Mean Difference (Final Values)|0.1||||0.406|2-Sided|95.0|-0.14|0.34||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 4 hour postdose|
1694306|NCT01062256|3115749|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.093|2-Sided|95.0|-0.33|0.03||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose|
1694307|NCT01062256|3115749|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.848|2-Sided|95.0|-0.24|0.19||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose|
1694308|NCT01062256|3115749|Superiority or Other||Mean Difference (Final Values)|0.13||||0.233|2-Sided|95.0|-0.09|0.35||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 3 hour postdose|
1694309|NCT01062256|3115749|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.166|2-Sided|95.0|-0.29|0.05||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose|
1694310|NCT01062256|3115749|Superiority or Other||Mean Difference (Final Values)|0.04||||0.688|2-Sided|95.0|-0.16|0.24||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose|
1694311|NCT01062256|3115749|Superiority or Other||Mean Difference (Final Values)|0.16||||0.125|2-Sided|95.0|-0.04|0.36||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 2 hour postdose|
1694312|NCT01062256|3115749|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.078|2-Sided|95.0|-0.27|0.01||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose|
1694313|NCT01062256|3115749|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.737|2-Sided|95.0|-0.2|0.14||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose|
1694314|NCT01062256|3115749|Superiority or Other||Mean Difference (Final Values)|0.1||||0.264|2-Sided|95.0|-0.08|0.27||p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms.|ANOVA|||Pairwise comparison of change from baseline in cough severity at 1 hour postdose|
1694315|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.19||||0.333|2-Sided|95.0|0.84|1.7||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose|
1694316|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.91||||0.58|2-Sided|95.0|0.64|1.28||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose|
1694317|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.76||||0.177|2-Sided|95.0|0.51|1.13||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose|
1694445|NCT01060540|3115904|Superiority or Other||incident rate ratio|0.9||||0.68|2-Sided|95.0|0.7|1.2||adjusted for baseline family history and BMI|generalized linear model for count data||||
1694318|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.14||||0.43|2-Sided|95.0|0.82|1.58||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose|
1694319|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.85||||0.371|2-Sided|95.0|0.6|1.21||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose|
1694320|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.75||||0.13|2-Sided|95.0|0.51|1.09||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose|
1694321|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.22||||0.228|2-Sided|95.0|0.88|1.69||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose|
1694322|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.94||||0.702|2-Sided|95.0|0.69|1.29||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose|
1694323|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.77||||0.146|2-Sided|95.0|0.54|1.09||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose|
1694324|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.03||||0.847|2-Sided|95.0|0.76|1.41||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose|
1694325|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.97||||0.857|2-Sided|95.0|0.7|1.35||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose|
1694326|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.94||||0.749|2-Sided|95.0|0.65|1.37||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose|
1694327|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.11||||0.481|2-Sided|95.0|0.83|1.48||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose|
1694328|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.07||||0.628|2-Sided|95.0|0.81|1.43||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose|
1694329|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.97||||0.834|2-Sided|95.0|0.71|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose|
1694330|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.11||||0.47|2-Sided|95.0|0.84|1.47||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose|
1694331|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.92||||0.601|2-Sided|95.0|0.69|1.24||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose|
1694332|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.83||||0.261|2-Sided|95.0|0.61|1.15||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose|
1694333|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.09||||0.532|2-Sided|95.0|0.83|1.44||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose|
1694334|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.87||||0.345|2-Sided|95.0|0.65|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose|
1694335|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.8||||0.147|2-Sided|95.0|0.59|1.08||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose|
1694336|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.03||||0.828|2-Sided|95.0|0.77|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose|
1694337|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.98||||0.904|2-Sided|95.0|0.72|1.33||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose|
1694338|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.95||||0.744|2-Sided|95.0|0.7|1.3||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose|
1694339|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.05||||0.736|2-Sided|95.0|0.79|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose|
1694340|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.97||||0.853|2-Sided|95.0|0.74|1.29||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose|
1694341|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.93||||0.6|2-Sided|95.0|0.7|1.23||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose|
1694342|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.02||||0.901|2-Sided|95.0|0.77|1.34||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose|
1694343|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.83||||0.212|2-Sided|95.0|0.62|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose|
1694344|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.82||||0.194|2-Sided|95.0|0.6|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose|
1694345|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.04||||0.785|2-Sided|95.0|0.79|1.37||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose|
1694346|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.87||||0.379|2-Sided|95.0|0.64|1.18||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose|
1694347|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.84||||0.289|2-Sided|95.0|0.61|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose|
1694348|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.08||||0.573|2-Sided|95.0|0.83|1.4||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose|
1694349|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.02||||0.923|2-Sided|95.0|0.74|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose|
1694350|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.94||||0.73|2-Sided|95.0|0.67|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose|
1694351|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.05||||0.687|2-Sided|95.0|0.82|1.35||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose|
1694352|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.88||||0.367|2-Sided|95.0|0.67|1.16||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose|
1694353|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.84||||0.215|2-Sided|95.0|0.64|1.11||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose|
1694354|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.04||||0.711|2-Sided|95.0|0.83|1.32||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose|
1694355|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.84||||0.165|2-Sided|95.0|0.66|1.07||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose|
1694356|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.81||||0.122|2-Sided|95.0|0.62|1.06||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose|
1694357|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.16||||0.207|2-Sided|95.0|0.92|1.46||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose|
1694358|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.9||||0.465|2-Sided|95.0|0.69|1.19||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose|
1694359|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.78||||0.091|2-Sided|95.0|0.58|1.04||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose|
1694360|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|1.14||||0.188|2-Sided|95.0|0.94|1.39||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose|
1694361|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.97||||0.802|2-Sided|95.0|0.75|1.25||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose|
1694362|NCT01062256|3115750|Superiority or Other||Odds Ratio (OR)|0.85||||0.25|2-Sided|95.0|0.64|1.12||p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time)|Poisson regression model|||Pairwise comparison of the number of cough bouts within 15 minutes postdose|
1694363|NCT01062256|3115751|Superiority or Other||Odds Ratio (OR)|1.08||||0.497|2-Sided|95.0|0.87|1.34||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.|
1694364|NCT01062256|3115751|Superiority or Other||Odds Ratio (OR)|0.91||||0.438|2-Sided|95.0|0.71|1.16||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.|
1694365|NCT01062256|3115751|Superiority or Other||Odds Ratio (OR)|0.84||||0.195|2-Sided|95.0|0.65|1.09||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 2-hour postdose period.|
1694366|NCT01062256|3115752|Superiority or Other||Odds Ratio (OR)|1.09||||0.459|2-Sided|95.0|0.87|1.38||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.|
1694367|NCT01062256|3115752|Superiority or Other||Odds Ratio (OR)|0.92||||0.513|2-Sided|95.0|0.72|1.18||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.|
1694368|NCT01062256|3115752|Superiority or Other||Odds Ratio (OR)|0.84||||0.216|2-Sided|95.0|0.64|1.1||p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) as the offset parameter.|Poisson regression model|||Pairwise comparison of number of cough bouts over 4-hour postdose period.|
1694369|NCT01062113|3115755|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1694370|NCT01062113|3115756|Superiority or Other|||||||0.0003|||||||t-test, 2 sided||||
1694371|NCT01062113|3115758|Superiority or Other||Risk Difference (RD)|38.2|Standard Error of the Mean|9.1|<|0.0001|2-Sided|95.0|20.3|56.1||The difference in the efficacy rates was tested using normal distribution at a significance level of 2-sided 5%. 2-sided 95% confidence interval (CI) for the difference in the efficacy rates was calculated using normal approximation.|asymptotic z-test||||
1694372|NCT01062061|3115767|Superiority or Other|||||||0.0001|||||||Chi-squared||||
1694373|NCT01062061|3115768|Superiority or Other|||||||0.9733|||||||Chi-squared||||
1694374|NCT01062009|3115771|Superiority or Other (legacy)|||||||0.24|||||||Chi-squared|||Chi square analysis comparing number of participants with new fever in each group|
1694446|NCT01060540|3115905|Superiority or Other||Mean Difference (Net)|-0.1||||0.05|2-Sided|95.0|-0.2|0.0||adjusted for baseline family history and BMI|Mixed Models Analysis||||
1694375|NCT01061866|3115773|Non-Inferiority or Equivalence|p less than or equal to 0.05, repeated measures ANOVA|Mean Difference (Final Values)|0.02|||<|0.02||||||p-value is non-adjusted for multiple comparisons|ANOVA|Was adjusted the degrees of freedom for the averaged test of significance.|The frequency of seizures at the beginning of the study and after treatment with thalidomide was contrasted in the same group patients.|Power=0.02|
1694376|NCT01061775|3115774|Superiority or Other (legacy)|||||||0.05|||||||t-test, 2 sided||||
1694377|NCT01061775|3115775|Superiority or Other (legacy)|||||||0.05|||||||t-test, 2 sided||||
1694378|NCT01061775|3115776|Superiority or Other (legacy)|||||||0.05|||||||t-test, 2 sided||||
1694379|NCT01061775|3115777|Superiority or Other (legacy)|||||||0.05|||||||t-test, 2 sided||||
1694380|NCT01061736|3115778|Superiority or Other||Odds Ratio (OR)|5.565|||<|0.0001|2-Sided|95.0|2.946|10.515||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel||||
1694381|NCT01061736|3115778|Superiority or Other||Odds Ratio (OR)|4.661|||<|0.0001|2-Sided|95.0|2.451|8.863||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoints were statistically significant).|
1694382|NCT01061736|3115779|Superiority or Other||||||<|0.0001||||||Threshold for significance = 0.025.|Rank ANCOVA||||
1694383|NCT01061736|3115779|Superiority or Other||||||<|0.0001||||||Threshold for significance = 0.025.|Rank ANCOVA|||Analysis was performed using two-sided rank-based ANCOVA model. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoints were statistically significant).|
1694384|NCT01061736|3115780|Superiority or Other||LS mean difference|-0.258|||<|0.0001|2-Sided|95.0|-0.336|-0.181||Threshold for significance = 0.025.|Mixed Models Analysis||||
1694385|NCT01061736|3115780|Superiority or Other||LS mean difference|-0.235|||<|0.0001|2-Sided|95.0|-0.312|-0.157||Threshold for significance = 0.025.|Mixed Models Analysis|||Analysis was performed using a mixed model for repeated measures (MMRM). Differences in least square (LS) mean between each dose of sarilumab and placebo were derived. Testing was performed according to the hierarchical testing procedure (performed only when the previous endpoint was statistically significant).|
1694386|NCT01061736|3115781|Superiority or Other||Odds Ratio (OR)|3.975|||<|0.0001|2-Sided|95.0|2.957|5.344||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel||||
1694387|NCT01061736|3115781|Superiority or Other||Odds Ratio (OR)|2.773|||<|0.0001|2-Sided|95.0|2.077|3.703||Threshold for significance = 0.025.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo was derived. The multiplicity issues for part B were addressed by using a Bonferroni correction for each dose together with a hierarchical testing procedure across the 3 co-primary and the main secondary endpoints. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 0.025 level.|
1694388|NCT01061736|3115782|Superiority or Other||Odds Ratio (OR)|2.34||||0.0426|2-Sided|95.0|1.03|5.29||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel||||
1694389|NCT01061736|3115782|Superiority or Other||Odds Ratio (OR)|2.38||||0.0363|2-Sided|95.0|1.06|5.35||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel||||
1694390|NCT01061736|3115782|Superiority or Other||Odds Ratio (OR)|1.17||||0.7119|2-Sided|95.0|0.52|2.61||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel||||
1694391|NCT01061736|3115782|Superiority or Other||Odds Ratio (OR)|3.84||||0.0041|2-Sided|95.0|1.53|9.63||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel||||
1694392|NCT01061736|3115782|Superiority or Other||Odds Ratio (OR)|1.99||||0.1155|2-Sided|95.0|0.85|4.64||Threshold for significance = 0.05.|Cochran-Mantel-Haenszel|||Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived. The multiplicity issues were addressed by using the Hommel-procedure.|
1694393|NCT01061723|3115794|Superiority or Other||Odds Ratio (OR)|1.8||||0.143|2-Sided|95.0|0.8|4.2||Threshold for significance = 0.05|Cochran-Mantel-Haenszel||||
1694394|NCT01061723|3115794|Superiority or Other||Odds Ratio (OR)|1.4||||0.496|2-Sided|95.0|0.6|3.4||Threshold for significance = 0.05|Cochran-Mantel-Haenszel||||
1694395|NCT01061723|3115794|Superiority or Other||Odds Ratio (OR)|0.8||||0.559|2-Sided|95.0|0.3|1.9||Threshold for significance = 0.05|Cochran-Mantel-Haenszel||||
1694396|NCT01061723|3115794|Superiority or Other||Odds Ratio (OR)|1.4||||0.467|2-Sided|95.0|0.6|3.5||Threshold for significance = 0.05|Cochran-Mantel-Haenszel||||
1694397|NCT01061723|3115794|Superiority or Other||Odds Ratio (OR)|1.0||||0.966|2-Sided|95.0|0.4|2.5||Threshold for significance = 0.05|Cochran-Mantel-Haenszel|||Sarilumab group was compared to placebo group. Analysis was performed using two-sided Cochran-Mantel-Haenszel test. Pairwise comparisons of the response rates between each dose of sarilumab and placebo were derived.|
1694398|NCT01061671|3115801|Superiority or Other|||||||0.1461|||||||t-test, 2 sided||||
1694399|NCT01061671|3115802|Superiority or Other|||||||0.34|||||||Log Rank||||
1694400|NCT01061671|3115803|Superiority or Other|||||||0.54|||||||negative binomial regression|Adjustments of confidence intervals for between-participant variation (overdispersion).|||
1694401|NCT01061385|3115818|Superiority or Other||Mean Difference (Net)|5.0|||||2-Sided|95.0|-37.7|38.0|||||The 95% CI range above is calculated for the current estimated value.||
1694402|NCT01061385|3115819|Superiority or Other||Mean Difference (Net)|7.5||||0.2922|2-Sided|95.0|-6.8|21.7|||t-test, 1 sided||||
1694403|NCT01061333|3115823|Superiority or Other||Geom. mean of fold change over Placebo|1.22||||0.2499|2-Sided|90.0|0.91|1.62||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale|||
1694404|NCT01061333|3115823|Superiority or Other||Geom. mean of fold change over Placebo|1.57||||0.0872|2-Sided|90.0|1.02|2.42||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale|||
1694405|NCT01061333|3115823|Superiority or Other||Geom. mean of fold change over Placebo|1.3||||0.1983|2-Sided|90.0|0.92|1.82||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale|||
1694407|NCT01061333|3115824|Superiority or Other||Geom. mean of fold change over Placebo|1.06||||0.7512|2-Sided|90.0|0.77|1.45||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale|||
1694408|NCT01061333|3115824|Superiority or Other||Geom. mean of fold change over Placebo|1.03||||0.8616|2-Sided|90.0|0.76|1.41||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale|||
1694409|NCT01061333|3115825|Superiority or Other||Geom. mean of fold change over Placebo|0.89||||0.1165|2-Sided|90.0|0.79|1.01||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale|||
1694410|NCT01061333|3115825|Superiority or Other||Geom. mean of fold change over Placebo|1.01||||0.941|2-Sided|90.0|0.81|1.25||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale|||
1694411|NCT01061333|3115825|Superiority or Other||Geom. mean of fold change over Placebo|1.03||||0.7501||90.0|0.88|1.2||p-Value not adjusted for simultaneous multiple comparisons|ANOVA|concentrations evaluated at log scale|||
1694412|NCT01061333|3115826|Superiority or Other||Geom. Mean Ratio of fold over baseline|0.92||||0.3738|2-Sided|90.0|0.77|1.08||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale|||
1694413|NCT01061333|3115826|Superiority or Other||Geom. Mean Ratio of fold over baseline|0.79||||0.0291|2-Sided|90.0|0.67|0.94||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale|||
1694414|NCT01061333|3115826|Superiority or Other||Geom. Mean Ratio of fold over baseline|0.67||||0.0006|2-Sided|90.0|0.57|0.8||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale|||
1694415|NCT01061333|3115827|Superiority or Other||Geom. Mean Ratio of fold over baseline|0.91||||0.614|2-Sided|90.0|0.65|1.26||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale|||
1694416|NCT01061333|3115827|Superiority or Other||Geom. Mean Ratio of fold over baseline|0.94||||0.8468|2-Sided|90.0|0.53|1.65||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated on log scale|||
1694417|NCT01061333|3115827|Superiority or Other||Geom. Mean Ratio of fold over baseline|0.9||||0.7622|2-Sided|90.0|0.51|1.59||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale|||
1694418|NCT01061333|3115828|Superiority or Other||Geom. Mean Ratio of fold over baseline|0.87||||0.2679|2-Sided|90.0|0.69|1.08||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale|||
1694419|NCT01061333|3115828|Superiority or Other||Geom. Mean Ratio of fold over baseline|0.59|||<|0.0001|2-Sided|90.0|0.49|0.7||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale|||
1694420|NCT01061333|3115828|Superiority or Other||Geom. Mean Ratio of fold over baseline|0.59|||<|0.0001|2-Sided|90.0|0.5|0.7||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale|||
1694421|NCT01061333|3115829|Superiority or Other||Geom. Mean Ratio of fold over baseline|1.3||||0.086|2-Sided|90.0|1.01|1.67||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale|||
1694422|NCT01061333|3115829|Superiority or Other||Geom. Mean Ratio of fold over baseline|1.41||||0.01|2-Sided|90.0|1.15|1.72||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale|||
1694423|NCT01061333|3115829|Superiority or Other||Geom. Mean Ratio of fold over baseline|1.27||||0.043|2-Sided|90.0|1.05|1.54||p-Value not adjusted for simultaneous multiple comparisons|ANCOVA|concentrations evaluated at log scale|||
1694424|NCT01061333|3115830|Superiority or Other||Difference in LS Mean|8.49||||0.0432|2-Sided|90.0|1.78|15.2||p-value not adjusted for simultaneous multiple comparisons|ANCOVA||||
1694425|NCT01061333|3115830|Superiority or Other||Difference in LS Mean|15.51||||0.0001|2-Sided|90.0|10.0|21.02||p-value not adjusted for simultaneous multiple comparisons|ANCOVA||||
1694426|NCT01061333|3115830|Superiority or Other||Difference in LS mean|16.22|||<|0.0001|2-Sided|90.0|10.74|21.69||p-value not adjusted for simultaneous multiple comparisons|ANCOVA||||
1694427|NCT01061151|3115877|Superiority||Hazard Ratio (HR)|0.55||||0.37|2-Sided|95.0|0.14|2.08|||Log Rank||The hazard ratio compares Arm A relative to Arm B.||
1694428|NCT01061151|3115878|Superiority|||||||0.98|||||||Log Rank||||
1694429|NCT01061151|3115879|Superiority||Hazard Ratio (HR)|1.0|||||2-Sided|96.0|0.3|3.1|||||The confidence interval was based on a repeated confidence interval.||
1694430|NCT01061151|3115880|Superiority|||||||0.46|||||||Fisher Exact|||Period 2|
1694431|NCT01061151|3115880|Superiority|||||||0.04|||||||Fisher Exact|||Period 2|
1694432|NCT01061151|3115880|Superiority||||||<|0.001|||||||Fisher Exact|||Periods 1 and 2|
1694433|NCT01061151|3115881|Superiority|||||||0.06|||||||Fisher Exact|||Period 2|
1694434|NCT01061151|3115881|Superiority|||||||0.64|||||||Fisher Exact|||Period 2|
1694435|NCT01061151|3115881|Superiority|||||||0.3|||||||Fisher Exact|||Periods 1 and 2|
1694436|NCT01061151|3115882|Superiority||||||>|0.99|||||||Fisher Exact|||Period 2|
1694437|NCT01061151|3115882|Superiority||||||>|0.77|||||||Fisher Exact|||Period 2|
1694438|NCT01061151|3115882|Superiority||||||>|0.008|||||||Fisher Exact|||Periods 1 and 2|
1694439|NCT01061151|3115883|Superiority||Risk Difference (RD)|-1.3|||||2-Sided|96.5|-2.1|-0.4|||||The combination of Arm B and Arm C minus Arm A, based on a repeated confidence interval (Lan–DeMets approach with an O’Brien–Fleming type I error spending function to preserve an experiment-wise type I error rate of 5%).|Arm B and Arm C were combined and compared to Arm A. This comparison was an a priori planned comparison.|
1694440|NCT01060553|3115902|Superiority or Other|||||||0.015|||||||t-test, 2 sided|||for sleep latency|
1694441|NCT01060553|3115902|Superiority or Other|||||||0.001|||||||t-test, 2 sided|||for sleep disturbance|
1694442|NCT01060553|3115902|Superiority or Other|||||||0.34|||||||t-test, 2 sided|||for sleep duration|
1694443|NCT01060553|3115903|Superiority or Other|||||||0.28|||||||t-test, 2 sided|||for pcs|
1694444|NCT01060553|3115903|Superiority or Other|||||||0.15|||||||t-test, 2 sided|||for mcs|
1696346|NCT01034397|3118724|Superiority or Other|||||||0.5||||||Change from Baseline to Week 12|Friedman's T test||||
1694447|NCT01060540|3115906|Superiority or Other||Mean Difference (Net)|-0.1||||0.38|2-Sided|95.0|-0.4|0.1||adjusted for stratification variables baseline BMI and family history|Mixed Models Analysis||||
1694448|NCT01060540|3115907|Superiority or Other||Mean Difference (Net)|0.1||||0.19|2-Sided|95.0|-0.1|0.3||adjusted for baseline BMI class and family history level stratification variables|Mixed Models Analysis||||
1694449|NCT01060540|3115908|Superiority or Other||Mean Difference (Net)|0.2||||0.44|2-Sided|95.0|-0.3|0.7|||Mixed Models Analysis|Adjusted for family history (low/unknown vs. high/moderate) and BMI>=35 (yes vs no) stratification variables|||
1694450|NCT01060111|3115935|Superiority or Other|||||||0.4326||||||Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.|ANOVA||||
1694451|NCT01060111|3115936|Superiority or Other|||||||0.9872|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.|||
1694452|NCT01060111|3115937|Superiority or Other|||||||0.7247|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.|||
1694453|NCT01060111|3115938|Non-Inferiority or Equivalence|Non-inferioirity was to be concluded if the ratio of percentage decrease in migraine episodes was greater than 0.7. Power of calculation was 0.9, significance level was 0.025.|Ratio of percentage decrease|0.95||||0.5|2-Sided|95.0|0.519|1.737|||t-test, 1 sided||||
1694454|NCT01060111|3115938|Superiority or Other|||||||0.6207|||||||ANOVA|Analysis of Variance (ANOVA) for treatment groups (Topiramate standard, Topiramate slow, Topiramate slow and Propranolol booster) was used.|||
1694455|NCT01060098|3115939|Superiority|||||||0.48|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12|
1694456|NCT01060098|3115939|Superiority|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12|
1694457|NCT01060098|3115939|Superiority|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||week 0 compared to week 12|
1694458|NCT01060059|3115945|Superiority or Other||Odds Ratio (OR)|1.0||||0.123|2-Sided|95.0|1.0|1.0|||Regression, Logistic|If several variables had Spearman's rho > 0.4 (for continuous) and Cramer's V > 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting triglycerides (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.|
1694459|NCT01060059|3115945|Superiority or Other||Odds Ratio (OR)|1.0||||0.259|2-Sided|95.0|1.0|1.01|||Regression, Logistic|If several variables had Spearman's rho > 0.4 (for continuous) and Cramer's V > 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting total cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.|
1694460|NCT01060059|3115945|Superiority or Other||Odds Ratio (OR)|0.99||||0.094|2-Sided|95.0|0.97|1.0|||Regression, Logistic|If several variables had Spearman's rho > 0.4 (for continuous) and Cramer's V > 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline fasting HDL cholesterol (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.|
1694461|NCT01060059|3115945|Superiority or Other||Odds Ratio (OR)|0.37||||0.007|2-Sided|95.0|0.18|0.77|||Regression, Logistic|If several variables had Spearman's rho > 0.4 (for continuous) and Cramer's V > 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher baseline creatinine (1mg/dL higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.|
1694462|NCT01060059|3115946|Superiority or Other||Odds Ratio (OR)|1.03||||0.026|2-Sided|95.0|1.0|1.05|||Regression, Logistic|If several variables had Spearman's rho > 0.4 (for continuous) and Cramer's V > 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if greater height (1 cm higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.|
1694463|NCT01060059|3115947|Superiority or Other||Odds Ratio (OR)|1.19|||<|0.001|2-Sided|95.0|1.15|1.23|||Regression, Logistic|If several variables had Spearman's rho > 0.4 (for continuous) and Cramer's V > 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if higher BMI (1 kg/m^2 higher) was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.|
1694464|NCT01060059|3115948|Superiority or Other||Odds Ratio (OR)|0.97|||<|0.001|2-Sided|95.0|0.95|0.99|||Regression, Logistic|If several variables had Spearman's rho > 0.4 (for continuous) and Cramer's V > 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if older age (1 year older), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.|
1694465|NCT01060059|3115949|Superiority or Other||Odds Ratio (OR)|0.98||||0.055|2-Sided|95.0|0.96|1.0|||Regression, Logistic|If several variables had Spearman's rho > 0.4 (for continuous) and Cramer's V > 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if longer duration of diabetes was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.|
1694466|NCT01060059|3115950|Superiority or Other||Odds Ratio (OR)|0.69|||<|0.001|2-Sided|95.0|0.6|0.78|||Regression, Logistic|If several variables had Spearman's rho > 0.4 (for continuous) and Cramer's V > 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if Baseline HbA1c was 1% more, was it associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.|
1694467|NCT01060059|3115951|Superiority or Other||Odds Ratio (OR)|1.21||||0.714|2-Sided|95.0|0.43|3.42||Baseline gastrointestinal symptoms (yes vs. no)|Regression, Logistic|||Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.|
1694468|NCT01060059|3115951|Superiority or Other||Odds Ratio (OR)|1.14||||0.554|2-Sided|95.0|0.74|1.76||Baseline Medical conditions (yes vs. no)|Regression, Logistic|||Logistic regression analysis was used to find factors associated with treatment choice at baseline. Covariates with more than 30% observations missing are omitted in this analysis. Weight was removed (high correlation with BMI) and also fasting blood glucose (lab value) was removed (high correlation with HbA1c). Missing values for remaining numeric covariates were replaced with means, and for categorical ones-with modes.|
1694469|NCT01060059|3115951|Superiority or Other||Odds Ratio (OR)|0.95||||0.831|2-Sided|95.0|0.62|1.46|||Regression, Logistic|If several variables had Spearman's rho > 0.4 (for continuous) and Cramer's V > 0.4 (for categorical covariates), only one was left in the model.||Logistic regression analysis was used to determine if Baseline Gender (Male vs. Female), was associated with treatment choice at baseline. Odds ratios were determined and if the odds ratio was greater than 1, it indicated it is more likely to initiate exenatide treatment. Covariates with more than 30% observations missing were omitted in this analysis. Missing values for remaining numeric covariates were replaced with means, and for categorical ones - with modes.|
1694470|NCT01059994|3115982|Superiority or Other|||||||0.004|||||||t-test, 2 sided||||
1694471|NCT01059994|3115983|Superiority or Other|||||||0.02|||||||t-test, 2 sided||||
1694472|NCT01059903|3116008|Non-Inferiority or Equivalence|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9046|||||2-Sided|90.0|0.8437|0.9699|||||Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).|
1694473|NCT01059903|3116009|Non-Inferiority or Equivalence|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9506|||||2-Sided|90.0|0.8833|1.0231|||||Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).|
1694474|NCT01059903|3116010|Non-Inferiority or Equivalence|If the 90% CI for the ratio of geometric LS-Means is included within 0.8-1.25, the patches are considered bioequivalent.|Ratio of geometric LS-Means|0.9028|||||2-Sided|90.0|0.8411|0.969|||||Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).|
1694475|NCT01059851|3116036|Non-Inferiority or Equivalence|"AUC(0-∞) GMR = AUC(0-∞) GM for Severe Renal Impairment Participants ÷ AUC(0-∞) GM for Healthy Participants.~A 90% CI for the AUC(0-∞) GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the 90% CI for the AUC(0-∞) GMR was contained within the interval [0.50, 2.00], then the hypothesis would be met and the AUC(0-∞) of suvorexant would be similar in both groups of participants. That is, if the true ratio of the GM AUC(0-∞) is greater than 0.50 and no more than 2.00."|AUC(0-∞) Geometric Mean Ratio|1.22|||||2-Sided|90.0|0.93|1.6||||||"The geometric mean (GM) for each participant group and the corresponding 95% confidence interval (CI) were calculated for AUC(0-∞) using an analysis of covariance (ANCOVA) model.~The AUC(0-∞) geometric mean ratio (GMR) of the 2 participant groups was used to test the primary hypothesis, which was that the AUC(0-∞) of suvorexant following a single oral dose would be similar between participants with renal impairment and healthy matched control participants."|
1694476|NCT01059825|3116041|Superiority or Other||Difference in least squares means|-22.75||||0|2-Sided|80.0|-29.58|-15.92||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694477|NCT01059825|3116041|Superiority or Other||Difference in least squares means|-34.81||||0|2-Sided|80.0|-41.76|-27.86||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694478|NCT01059825|3116041|Superiority or Other||Difference in least squares means|-35.4||||0|2-Sided|80.0|-42.3|-28.51||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694479|NCT01059825|3116041|Superiority or Other||Difference in least squares means|-28.51||||0|2-Sided|80.0|-35.35|-21.67||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694480|NCT01059825|3116041|Superiority or Other||Difference in least squares means|-22.07||||0|2-Sided|80.0|-28.87|-15.27||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694481|NCT01059825|3116042|Superiority or Other||Difference in least squares means|-23.17||||0|2-Sided|80.0|-30.28|-16.07||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694482|NCT01059825|3116042|Superiority or Other||Difference in least squares means|-31.79||||0|2-Sided|80.0|-39.02|-24.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694483|NCT01059825|3116042|Superiority or Other||Difference in least squares means|-33.12||||0|2-Sided|80.0|-40.29|-25.95||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694484|NCT01059825|3116042|Superiority or Other||Difference in least squares means|-27.94||||0|2-Sided|80.0|-35.06|-20.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694485|NCT01059825|3116042|Superiority or Other||Difference in least squares means|-22.09||||0|2-Sided|80.0|-29.16|-15.01||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694486|NCT01059825|3116043|Superiority or Other||Difference in least squares means|-20.57||||0|2-Sided|80.0|-28.19|-12.96||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694487|NCT01059825|3116043|Superiority or Other||Difference in least squares means|-22.33||||0|2-Sided|80.0|-30.05|-14.61||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694488|NCT01059825|3116043|Superiority or Other||Difference in least squares means|-32.54||||0|2-Sided|80.0|-40.2|-24.88||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694489|NCT01059825|3116043|Superiority or Other||Difference in least squares means|-21.57||||0|2-Sided|80.0|-29.27|-13.86||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694490|NCT01059825|3116043|Superiority or Other||Difference in least squares means|-20.96||||0|2-Sided|80.0|-28.58|-13.34||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694491|NCT01059825|3116044|Superiority or Other||Difference in least squares means|-20.05||||0|2-Sided|80.0|-27.39|-12.72||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694492|NCT01059825|3116044|Superiority or Other||Difference in least squares means|-32.02||||0|2-Sided|80.0|-39.49|-24.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694493|NCT01059825|3116044|Superiority or Other||Difference in least squares means|-34.23||||0|2-Sided|80.0|-41.64|-26.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694494|NCT01059825|3116044|Superiority or Other||Difference in least squares means|-25.82||||0|2-Sided|80.0|-33.17|-18.47||P-value is one-sided.P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694495|NCT01059825|3116044|Superiority or Other||Difference in least squares means|-20.99||||0|2-Sided|80.0|-28.29|-13.69||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694496|NCT01059825|3116046|Superiority or Other||Difference in least squares means|-0.48||||0.357|2-Sided|80.0|-2.15|1.19||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694497|NCT01059825|3116046|Superiority or Other||Difference in least squares means|-1.99||||0.066|2-Sided|80.0|-3.69|-0.3||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694498|NCT01059825|3116046|Superiority or Other||Difference in least squares means|-3.03||||0.011|2-Sided|80.0|-4.72|-1.34||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694499|NCT01059825|3116046|Superiority or Other||Difference in least squares means|-1.49||||0.126|2-Sided|80.0|-3.16|0.18||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694500|NCT01059825|3116046|Superiority or Other||Difference in least squares means|-2.2||||0.045|2-Sided|80.0|-3.86|-0.54||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694501|NCT01059825|3116047|Superiority or Other||Difference in least squares means|0.29||||0.602|2-Sided|80.0|-1.13|1.7||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694635|NCT01058265|3116335|Superiority or Other|||||||0.487|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in PCS between two groups.|
1694502|NCT01059825|3116047|Superiority or Other||Difference in least squares means|-1.3||||0.121|2-Sided|80.0|-2.73|0.12||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694503|NCT01059825|3116047|Superiority or Other||Difference in least squares means|-2.01||||0.035|2-Sided|80.0|-3.43|-0.59||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694504|NCT01059825|3116047|Superiority or Other||Difference in least squares means|-2.29||||0.019|2-Sided|80.0|-3.69|-0.88||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694505|NCT01059825|3116047|Superiority or Other||Difference in least squares means|-1.67||||0.063|2-Sided|80.0|-3.07|-0.27||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694506|NCT01059825|3116048|Superiority or Other||Difference in least squares means|1.49||||0.883|2-Sided|80.0|-0.11|3.08||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694507|NCT01059825|3116048|Superiority or Other||Difference in least squares means|-2.44||||0.026|2-Sided|80.0|-4.05|-0.84||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694508|NCT01059825|3116048|Superiority or Other||Difference in least squares means|-1.41||||0.13|2-Sided|80.0|-3.01|0.19||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694509|NCT01059825|3116048|Superiority or Other||Difference in least squares means|-0.7||||0.288|2-Sided|80.0|-2.31|0.91||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694510|NCT01059825|3116048|Superiority or Other||Difference in least squares means|-0.69||||0.289|2-Sided|80.0|-2.27|0.9||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694511|NCT01059825|3116049|Superiority or Other||Difference in least squares means|0.88||||0.746|2-Sided|80.0|-0.82|2.58||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694512|NCT01059825|3116049|Superiority or Other||Difference in least squares means|-2.64||||0.025|2-Sided|80.0|-4.37|-0.92||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694513|NCT01059825|3116049|Superiority or Other||Difference in least squares means|-3.99||||0.002|2-Sided|80.0|-5.71|-2.27||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694514|NCT01059825|3116049|Superiority or Other||Difference in least squares means|-1.81||||0.086|2-Sided|80.0|-3.51|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694515|NCT01059825|3116049|Superiority or Other||Difference in least squares means|-1.93||||0.072|2-Sided|80.0|-3.62|-0.24||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694516|NCT01059825|3116051|Superiority or Other||Difference in least squares means|-2.0||||0.179|2-Sided|80.0|-4.78|0.79||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694517|NCT01059825|3116051|Superiority or Other||Difference in least squares means|-2.87||||0.097|2-Sided|80.0|-5.69|-0.04||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694518|NCT01059825|3116051|Superiority or Other||Difference in least squares means|-2.61||||0.117|2-Sided|80.0|-5.42|0.2||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694519|NCT01059825|3116051|Superiority or Other||Difference in least squares means|-2.41||||0.133|2-Sided|80.0|-5.19|0.37||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694520|NCT01059825|3116051|Superiority or Other||Difference in least squares means|-1.1||||0.306|2-Sided|80.0|-3.87|1.67||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694521|NCT01059825|3116052|Superiority or Other||Difference in least squares means|-0.76||||0.346|2-Sided|80.0|-3.21|1.7||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694522|NCT01059825|3116052|Superiority or Other||Difference in least squares means|-0.77||||0.346|2-Sided|80.0|-3.25|1.71||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694523|NCT01059825|3116052|Superiority or Other||Difference in least squares means|-2.86||||0.068|2-Sided|80.0|-5.33|-0.4||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694524|NCT01059825|3116052|Superiority or Other||Difference in least squares means|-2.59||||0.087|2-Sided|80.0|-5.03|-0.14||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694525|NCT01059825|3116052|Superiority or Other||Difference in least squares means|-1.38||||0.234|2-Sided|80.0|-3.81|1.05||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694526|NCT01059825|3116053|Superiority or Other||Difference in least squares means|1.01||||0.694|2-Sided|80.0|-1.55|3.58||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694527|NCT01059825|3116053|Superiority or Other||Difference in least squares means|-3.47||||0.043|2-Sided|80.0|-6.05|-0.89||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694528|NCT01059825|3116053|Superiority or Other||Difference in least squares means|-0.35||||0.43|2-Sided|80.0|-2.92|2.21||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694529|NCT01059825|3116053|Superiority or Other||Difference in least squares means|-2.81||||0.082|2-Sided|80.0|-5.38|-0.23||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694530|NCT01059825|3116053|Superiority or Other||Difference in least squares means|-0.37||||0.425|2-Sided|80.0|-2.91|2.17||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694531|NCT01059825|3116054|Superiority or Other||Difference in least squares means|-0.54||||0.403|2-Sided|80.0|-3.33|2.26||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694532|NCT01059825|3116054|Superiority or Other||Difference in least squares means|-3.37||||0.064|2-Sided|80.0|-6.21|-0.53||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694533|NCT01059825|3116054|Superiority or Other||Difference in least squares means|-2.88||||0.096|2-Sided|80.0|-5.7|-0.05||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694534|NCT01059825|3116054|Superiority or Other||Difference in least squares means|-3.48||||0.056|2-Sided|80.0|-6.28|-0.68||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694535|NCT01059825|3116054|Superiority or Other||Difference in least squares means|-2.13||||0.163|2-Sided|80.0|-4.92|0.65||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694536|NCT01059825|3116056|Superiority or Other||Difference in least squares means|0.24||||0.741|2-Sided|80.0|-0.24|0.71||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694537|NCT01059825|3116056|Superiority or Other||Difference in least squares means|-1.78||||0|2-Sided|80.0|-2.26|-1.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694538|NCT01059825|3116056|Superiority or Other||Difference in least squares means|-1.68||||0|2-Sided|80.0|-2.16|-1.21||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694539|NCT01059825|3116056|Superiority or Other||Difference in least squares means|-1.57||||0|2-Sided|80.0|-2.04|-1.09||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694540|NCT01059825|3116056|Superiority or Other||Difference in least squares means|-1.03||||0.003|2-Sided|80.0|-1.51|-0.56||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694541|NCT01059825|3116057|Superiority or Other||Odds Ratio (OR)|0.45||||0.922|2-Sided|80.0|0.04|0.86||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694542|NCT01059825|3116057|Superiority or Other||Odds Ratio (OR)|-1.08||||0|2-Sided|80.0|-1.49|-0.67||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward..|||
1694543|NCT01059825|3116057|Superiority or Other||Difference in least squares means|-1.24||||0|2-Sided|80.0|-1.65|-0.83||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694544|NCT01059825|3116057|Superiority or Other||Difference in least squares means|-1.32||||0|2-Sided|80.0|-1.73|-0.91||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694545|NCT01059825|3116057|Superiority or Other||Difference in least squares means|-0.76||||0.008|2-Sided|80.0|-1.17|-0.36||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694546|NCT01059825|3116058|Superiority or Other||Difference in least squares means|0.45||||0.967|2-Sided|80.0|0.14|0.76||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694547|NCT01059825|3116058|Superiority or Other||Difference in least squares means|-0.87||||0|2-Sided|80.0|-1.18|-0.55||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694548|NCT01059825|3116058|Superiority or Other||Difference in least squares means|-0.9||||0|2-Sided|80.0|-1.22|-0.59||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694549|NCT01059825|3116058|Superiority or Other||Difference in least squares means|-1.13||||0|2-Sided|80.0|-1.44|-0.81||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694550|NCT01059825|3116058|Superiority or Other||Difference in least squares means|-0.42||||0.043|2-Sided|80.0|-0.73|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694551|NCT01059825|3116059|Superiority or Other||Difference in least squares means|0.45||||0.833|2-Sided|80.0|-0.15|1.06||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694552|NCT01059825|3116059|Superiority or Other||Difference in least squares means|-1.91||||0|2-Sided|80.0|-2.52|-1.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1696347|NCT01034397|3118724|Superiority or Other||||||<|0.001||||||Change from Baseline to Week 12|Friedman's T test||||
1694553|NCT01059825|3116059|Superiority or Other||Difference in least squares means|-2.15||||0|2-Sided|80.0|-2.76|-1.54||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694554|NCT01059825|3116059|Superiority or Other||Difference in least squares means|-1.75||||0|2-Sided|80.0|-2.35|-1.14||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694555|NCT01059825|3116059|Superiority or Other||Difference in least squares means|-1.15||||0.007|2-Sided|80.0|-1.75|-0.55||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694556|NCT01059825|3116061|Superiority or Other||Difference in least squares means|-0.67||||0|2-Sided|80.0|-0.84|-0.5||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694557|NCT01059825|3116061|Superiority or Other||Difference in least squares means|-0.65||||0|2-Sided|80.0|-0.82|-0.47||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694558|NCT01059825|3116061|Superiority or Other||Difference in least squares means|-0.63||||0|2-Sided|80.0|-0.8|-0.45||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694559|NCT01059825|3116061|Superiority or Other||Difference in least squares means|-0.66||||0|2-Sided|80.0|-0.83|-0.49||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694560|NCT01059825|3116061|Superiority or Other||Difference in least squares means|-0.47||||0|2-Sided|80.0|-0.64|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694561|NCT01059825|3116062|Superiority or Other||Difference in least squares means|-0.44||||0|2-Sided|80.0|-0.57|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694562|NCT01059825|3116062|Superiority or Other||Difference in least squares means|-0.36||||0|2-Sided|80.0|-0.49|-0.22||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694563|NCT01059825|3116062|Superiority or Other||Difference in least squares means|-0.44||||0|2-Sided|80.0|-0.57|-0.3||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694564|NCT01059825|3116062|Superiority or Other||Difference in least squares means|-0.45||||0|2-Sided|80.0|-0.59|-0.32||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694565|NCT01059825|3116062|Superiority or Other||Difference in least squares means|-0.37||||0|2-Sided|80.0|-0.5|-0.23||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694566|NCT01059825|3116063|Superiority or Other||Difference in least squares means|-0.25||||0.001|2-Sided|80.0|-0.36|-0.15||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694567|NCT01059825|3116063|Superiority or Other||Difference in least squares means|-0.17||||0.02|2-Sided|80.0|-0.27|-0.06||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694568|NCT01059825|3116063|Superiority or Other||Difference in least squares means|-0.22||||0.004|2-Sided|80.0|-0.32|-0.11||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694569|NCT01059825|3116063|Superiority or Other||Difference in least squares means|-0.29||||0|2-Sided|80.0|-0.39|-0.18||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694570|NCT01059825|3116063|Superiority or Other||Difference in least squares means|-0.13||||0.049|2-Sided|80.0|-0.24|-0.03||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694571|NCT01059825|3116064|Superiority or Other||Difference in least squares means|-0.76||||0|2-Sided|80.0|-0.97|-0.56||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.|||
1694572|NCT01059825|3116064|Superiority or Other||Difference in least squares means|-0.72||||0|2-Sided|80.0|-0.93|-0.52||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.|
1694573|NCT01059825|3116064|Superiority or Other||Difference in least squares means|-0.62||||0|2-Sided|80.0|-0.82|-0.42||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.|
1694636|NCT01058096|3116342|Superiority or Other||Least Squares Mean Difference|-0.4||||0.0027|2-Sided|95.0|-0.7|-0.1|||MMRM analysis||cariprazine - placebo||
1696348|NCT01034397|3118726|Superiority or Other|||||||0.002|||||||t-test, 1 sided||||
1694574|NCT01059825|3116064|Superiority or Other||Difference in least squares means|-0.69||||0|2-Sided|80.0|-0.89|-0.49||P-value is one-sided. P-value is rounded to 3 decimals; therefore, p <0.0005 is reported as 0.000.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.|
1694575|NCT01059825|3116064|Superiority or Other||Difference in least squares means|-0.45||||0.002|2-Sided|80.0|-0.65|-0.25||P-value is one-sided.|ANCOVA|ANCOVA model with treatment as fixed effect and baseline as covariate with last observation carried forward.||The null hypothesis is that there is no difference between ertugliflozin and placebo on the primary endpoint.|
1694576|NCT01059630|3116145|Superiority or Other (legacy)||Hazard Ratio (HR)|0.77||||0.081|2-Sided|95.0|0.57|1.03|||Log Rank||||
1694577|NCT01059630|3116147|Superiority or Other (legacy)||Hazard Ratio (HR)|0.57||||0.0001|2-Sided|95.0|0.44|0.74|||Log Rank||||
1694578|NCT01059630|3116148|Superiority or Other (legacy)||Hazard Ratio (HR)|0.48|||||2-Sided|95.0|0.29|0.81|||||||
1694579|NCT01059630|3116149|Superiority or Other (legacy)||Hazard Ratio (HR)|0.13|||||2-Sided|95.0|0.04|0.45|||||||
1694580|NCT01059630|3116150|Superiority or Other (legacy)||Hazard Ratio (HR)|0.51|||||2-Sided|95.0|0.39|0.67|||||||
1694581|NCT01059630|3116151|Superiority or Other (legacy)||Hazard Ratio (HR)|0.43|||||2-Sided|95.0|0.31|0.61|||||||
1694582|NCT01059630|3116152|Superiority or Other (legacy)||Difference in response rate|8.55||||0.0466|2-Sided|95.0|-0.22|17.32|||Cochran-Mantel-Haenszel||||
1694583|NCT01059630|3116153|Superiority or Other (legacy)||Difference in response rate|2.24||||0.8347|2-Sided|95.0|-7.2|11.69|||Cochran-Mantel-Haenszel||||
1694584|NCT01059630|3116158|Superiority or Other (legacy)||Difference in response rate|-0.9||||0.7857|2-Sided|95.0|-8.44|6.64|||Cochran-Mantel-Haenszel||||
1694585|NCT01059630|3116159|Superiority or Other (legacy)||Difference in response rate|0.98||||0.9298|2-Sided|95.0|0.58|1.65|||Cochran-Mantel-Haenszel||||
1694586|NCT01059630|3116160|Superiority or Other (legacy)||Hazard Ratio (HR)|0.57|||<|0.0001|2-Sided|95.0|0.45|0.73|||Log Rank||||
1694587|NCT01059630|3116162|Superiority or Other (legacy)||Hazard Ratio (HR)|0.53|||<|0.0001|2-Sided|95.0|0.4|0.7|||Log Rank||||
1694588|NCT01059565|3116208|Superiority or Other|||||||0.284|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.|
1694589|NCT01059565|3116209|Superiority or Other|||||||0.646|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.|
1694590|NCT01059565|3116210|Superiority or Other|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.|
1694591|NCT01059565|3116211|Superiority or Other||Difference in LSM|0.93||||0.232|2-Sided|95.0|-0.62|2.48|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.|
1694592|NCT01059565|3116212|Superiority or Other||Difference in LSM|0.14||||0.531|2-Sided|95.0|-0.29|0.56|||Mixed Models Analysis|P-value was based on a Mixed-Effect Model Repeated Measure model that included terms for treatment, visit, baseline, and treatment/visit interaction.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.|
1694593|NCT01059565|3116213|Superiority or Other||Difference in LSM|3.62||||0.132|2-Sided|95.0|-1.11|8.34|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.|
1694594|NCT01059565|3116214|Superiority or Other||Difference in LSM|-2.57||||0.528|2-Sided|95.0|-10.62|5.49|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.|
1694595|NCT01059565|3116215|Superiority or Other||Difference in LSM|2.99||||0.17|2-Sided|95.0|-1.2|7.28|||ANCOVA|Baseline was included as a covariate in this model.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.|
1694596|NCT01059565|3116216|Superiority or Other||Difference in LSM|1.95||||0.553|2-Sided|95.0|-4.54|8.44|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.|
1694597|NCT01059565|3116217|Superiority or Other||Difference in LSM|0.6||||0.762|2-Sided|95.0|-3.3|4.49|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.|
1694598|NCT01059565|3116218|Superiority or Other||Difference in LSM|0.77||||0.711|2-Sided|95.0|-3.33|4.86|||ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.|
1694599|NCT01059565|3116219|Superiority or Other||Difference in LSM|0.18||||0.939|2-Sided|95.0|-4.43|1.78||To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.|ANCOVA|The AUCs of changes from baseline were compared between treatment groups using ANCOVA methods with baseline value as a covariate.||Null hypothesis was that there was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.|
1694637|NCT01058096|3116343|Superiority or Other||Least Squares Mean Difference|-4.3||||0.0004|2-Sided|95.0|-6.7|-1.9|||Mixed Models Analysis||cariprazine - placebo||
1694663|NCT01057589|3116386|Superiority or Other|||||||0.17||||||P-value is for EIP, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694600|NCT01059565|3116220|Superiority or Other|||||||0.4158||||||To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.|Negative binomial regression|The negative binomial regression model included an offset parameter which accounted for potential differing study durations due to discontinuations.||The primary analysis was a test for superiority. Null hypothesis was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.|
1694601|NCT01059565|3116221|Superiority or Other||Difference in least squares mean (LSM)|0.91||||0.663|2-Sided|95.0|-3.24|5.06||"To correct for multiplicity, a family alpha spending rule was used to control the type 1 error rate of alpha=0.05.~A gate-keeping procedure to control family-wise Type 1 error was established a priori for primary and key secondary endpoints."|ANCOVA|Baseline was included as a covariate in this model.||"The primary analysis was a test for superiority. Null hypothesis was no difference between the AZLI and placebo treatment groups versus the alternative hypothesis that there was a difference.~A sample size of 50 participants per group provided at least 80% power to detect an 8.5% difference in mean AUCave of relative change from baseline in FEV1 % predicted through Week 24 using a two-sided 0.05-level test, assuming a common standard deviation of 15."|
1694602|NCT01059344|3116266|Superiority|||||||0.011|||||||Chi-squared||||
1694603|NCT01059344|3116267|Superiority||||||<|0.001|||||||Chi-squared||||
1694604|NCT01059344|3116268|Superiority||||||<|0.001|||||||Chi-squared||||
1694605|NCT01059344|3116269|Superiority|||||||0.01|||||||Chi-squared||||
1694606|NCT01059344|3116270|Superiority||||||<|0.001|||||||Chi-squared||||
1694607|NCT01059344|3116271|Superiority||||||<|0.001|||||||Chi-squared||||
1694608|NCT01059344|3116272|Superiority or Other|||||||0.069|||||||Chi-squared||||
1694609|NCT01058993|3116289|Superiority or Other||||||<|0.05|||||||Ratio paired t-test|Ratio paired t-test for comparison of baselines and responses for each category of leukocytes||The patients' leukocyte counts before and after plerixafor were compared.|
1694610|NCT01058993|3116289|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|Student t-test-comparison means of normal subjects & controls.|||
1694611|NCT01058941|3116290|Other||Mean Difference (Net)|-3.68||||0.001|2-Sided|95.0|-5.9|-1.46||We used a significance level of p = 0.025 for our measure of ADAS-cog changes based on a simple Bonferroni adjustment since we have two primary outcomes.|Mixed Models Analysis|Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.||The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.|
1694612|NCT01058941|3116291|Other||Mean Difference (Net)|-0.42||||0.82|2-Sided|95.0|-3.97|3.13||We used a significance level of p = 0.025 for our measure of ADL changes based on a simple Bonferroni adjustment since we have two primary outcomes.|Mixed Models Analysis|Adjusted for baseline outcome, time from baseline, age, education category, BMI, cholinesterase inhibitors, memantine, vitamin E, and Apo-E.||The target enrollment was 60 subjects, allowing for up to a 20% drop-out. It was calculated that with 48 subjects (24 per group) we would have 80% power to see differences in ADL scores over 18 months between the treatment and placebo groups with a significance level of 0.025 based on a simple Bonferroni adjustment, since we had two primary outcomes.|
1694613|NCT01058863|3116293|Superiority or Other||Mean Difference (Final Values)|25.61|Standard Error of the Mean|3.68|<|0.0001|2-Sided|95.0|18.36|32.85||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.|
1694614|NCT01058863|3116293|Superiority or Other||Mean Difference (Final Values)|33.1|Standard Error of the Mean|3.686|<|0.0001|2-Sided|95.0|25.84|40.35||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.|
1694615|NCT01058863|3116293|Superiority or Other||Mean Difference (Final Values)|27.73|Standard Error of the Mean|3.686|<|0.001|2-Sided|95.0|20.47|34.99||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.|
1694616|NCT01058863|3116293|Superiority or Other||Mean Difference (Final Values)|33.47|Standard Error of the Mean|3.69|<|0.0001|2-Sided|95.0|26.21|40.74||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline PPFEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.|
1694662|NCT01057589|3116386|Superiority or Other|||||||0.45||||||P-value is for EIP, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694617|NCT01058863|3116294|Superiority or Other||Mean Difference (Final Values)|0.88|Standard Error of the Mean|0.136|<|0.0001|2-Sided|95.0|0.61|1.15||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.|
1694618|NCT01058863|3116294|Superiority or Other||Mean Difference (Final Values)|1.08|Standard Error of the Mean|0.136|<|0.0001|2-Sided|95.0|0.81|1.35||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level..|
1694619|NCT01058863|3116294|Superiority or Other||Mean Difference (Final Values)|0.97|Standard Error of the Mean|0.136|<|0.0001|2-Sided|95.0|0.7|1.24||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.|
1694620|NCT01058863|3116294|Superiority or Other||Mean Difference (Final Values)|1.15|Standard Error of the Mean|0.136|<|0.0001|2-Sided|95.0|0.88|1.42||Significance at the 0.05 level.|ANOVA|Fixed effects of baseline FEV1 as a covariate, sequence, treatment group, period, and center, and random effect for subject within sequence.||Of interest was the mean difference between each active group and placebo at each dose level. Analyses were performed at the 2-sided 0.05 significance level in this sequence: Albuterol Spiromax 180 mcg versus placebo; Albuterol Spiromax 90 mcg versus placebo, ProAir HFA 180 mcg versus placebo, and ProAir HFA 90 mcg versus placebo. If a test was not significant, no further tests were done. This sequential procedure preserved the error rate for the family of tests at the 0.05 level.|
1694621|NCT01058668|3116309|Superiority or Other||Least Squares Mean Difference|-0.6|||<|0.001|2-Sided|95.0|-0.9|-0.3|||Mixed Models Analysis||cariprazine (6-12 mg/day) - placebo||
1694622|NCT01058668|3116309|Superiority or Other||Least Squares Mean Difference|-0.6|||<|0.001|2-Sided|95.0|-0.9|-0.4|||Mixed Models Analysis||cariprazine (3-6 mg/day) - placebo||
1694623|NCT01058668|3116310|Superiority or Other||Least Squares Mean Difference|-5.9|||<|0.001|2-Sided|95.0|-8.2|-3.6|||Mixed Models Analysis||cariprazine (6-12 mg/day) - placebo||
1694624|NCT01058668|3116310|Superiority or Other||Least Squares Mean Difference|-6.1|||<|0.001|2-Sided|95.0|-8.4|-3.8|||Mixed Models Analysis||cariprazine (3-6 mg/day) - placebo||
1694625|NCT01058395|3116327|Superiority||Mean Difference (Final Values)|176.0|||>|0.05|1-Sided||||||t-test, 2 sided||||
1694626|NCT01058395|3116329|Superiority|t-test||||||0.541|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between groups in the DRS scores at 4 weeks.|
1694627|NCT01058395|3116329|Superiority|||||||0.258|||||||t-test, 2 sided|||Null hypothesis is that there is no difference between groups in the DRS scores at 3 months.|
1694628|NCT01058395|3116329|Superiority|"Comparison between groups at 3 months (primary).~Comparison between the 2 tiers."||||||0.021||||||P-value|ANCOVA|Threshold for significance was P-value < 0.05||DRS levels changes at from 4 weeks to 3 months comparing the different doses.|
1694629|NCT01058356|3116330|Superiority or Other||Odds Ratio (OR)|0.85|Standard Error of the Mean|0.27|<|0.05|2-Sided|95.0|0.18|1.55|||Regression, Logistic|||"Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects"|
1694630|NCT01058356|3116331|Superiority or Other||Odds Ratio (OR)|0.84|Standard Error of the Mean|0.4|<|0.05|2-Sided|95.0|0.17|4.15|||Regression, Logistic|||"Null hypothesis: The efficay of the probiotic Lactobacilli (Lacidofil cap®) for the prevention of AAD in adults is not different form the placebo group in multi-center, randomized, placebo-controlled, double-blind trial.~Power calculation:~The assumption of sample size calculation:~difference 18% (8% : 26%) α: 0.05, statistical power: 90%, two sided difference: 18% Compliance: 80%~- Unadjusted sample size (N=200) 180 + 10(%) drop out = 180 + 180/ (1-0.1)2 = 222.2 Total 220 subjects"|
1694631|NCT01058304|3116332|Superiority or Other||Mean Difference (Final Values)|-0.113||||0.527|2-Sided|95.0|-0.463|0.238|||Mixed Models Analysis|||The analysis compares Arms 1 and 2 at 12-week follow-up. The hypothesis being tested is that the group-based PT program (Arm 1) will result in a significantly greater improvement in SPPB scores compared with the individual PT program (Arm 2).|
1694632|NCT01058304|3116333|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.444|2-Sided|95.0|-4.64|2.04|||Mixed Models Analysis|||The hypothesis being tested is that the group-based PT program (Arm 1) will result in greater improvements in WOMAC scores at 24-week follow-up (12 weeks after the end of the group program) when compared to usual PT care (Arm 2).|
1694633|NCT01058304|3116333|Superiority or Other||Mean Difference (Final Values)|-2.67||||0.1024|2-Sided|95.0|-5.87|0.538|||Mixed Models Analysis|||"The analysis compares study Arm 1 and Arm 2 at 24-week follow-up, with 12-week data also included in the response trajectory.~The hypothesis being tested is that group-based PT (Arm 1) will result in a significantly greater improvement WOMAC scores compared to individual PT (Arm 2)"|
1694634|NCT01058265|3116334|Superiority or Other|||||||0.817|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no difference in MCS between two groups.|
1694638|NCT01057888|3116349|Superiority or Other||Hazard Ratio (HR)|1.1||||0.234|2-Sided|95.0|1.0|1.2|||Regression, Cox||The mail reminder arm represents the numerator and the telephone reminder arm represents the denominator|The null hypothesis was that there would be no difference in the well child care rate among adolescents in the mailed reminder arm versus adolescents in the telephone reminder arm of the intervention|
1694639|NCT01057888|3116349|Superiority or Other||Hazard Ratio (HR)|1.1|||<|0.05|2-Sided|95.0|1.0|1.3|||Regression, Cox||The control group represents the denominator and the telephone reminder group represents the numerator|The null hypothesis is the the well child care rates of adolescents in the telephone reminder group would not differ from those of the control group|
1694640|NCT01057888|3116349|Superiority or Other||Hazard Ratio (HR)|1.2|||<|0.01|2-Sided|95.0|1.1|1.3|||Regression, Cox||The control group represents the denominator and the mailed reminder group represents the numerator.|The null hypothesis was that a difference in well child care rates among adolescents whose families received a mailed reminder compared to the control group|
1694641|NCT01057888|3116350|Superiority or Other||Hazard Ratio (HR)|1.2||||0.075|2-Sided|95.0|1.0|1.6|||Regression, Cox||The mail reminder arm represents the numerator and the telephone reminder arm represents the denominator.|The null hypothesis was that there is no difference in the percentage of fully vaccinated adolescents between the mailed reminder versus the telephone reminder arms|
1694642|NCT01057888|3116350|Superiority or Other||Hazard Ratio (HR)|1.6|||<|0.01|2-Sided|95.0|1.3|2.1|||Regression, Cox|We used a robust, clustered, stratified Cox regression model.|The control group represents the denominator. The letter reminder group represents the numerator.||
1694643|NCT01057888|3116350|Superiority or Other||Hazard Ratio (HR)|1.3|||<|0.05|2-Sided|95.0|1.0|1.7|||Regression, Cox|It is a robust, clustered stratified Cox regression model|The control group serves as the denominator. The telephone reminder group serves as the numerator.|The null hypothesis is that there is no difference in total immunization status between the control group and the group receiving telephone (autodialer) reminders. This was analyzed using a clustered, stratified Cox model.|
1694644|NCT01057862|3116351|Other|We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.|Mean Difference (Final Values)|14.2|Standard Deviation|9.45|||2-Sided||||||||The active treatment arm had a mean G-SAS score of 26.8 (n=5) at study start with a SD of 11.73. At end the active treatment arm had a mean G-SAS score of 12.6 (n=5) with a SD of 9.45. The placebo arm is not included as there were only 2 scores.|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.|
1694645|NCT01057862|3116352|Other|We are including the mean and SD of each arm at the start and end of study only as a comparison and not a meaningful analysis. Since higher scores represent a more severe form of the disorder, a drop in scores is seen as an indicator that the treatment had an effect.|Mean Difference (Final Values)|6.0|Standard Deviation|9.35|||2-Sided||||||||The active arm had a mean PG-YBOCS score of 16 (n=5) at study start with a SD of 7.35. At end of study the active arm had a mean PG-YBOCS score of 10 (n=5) with a SD of 9.35. The placebo arm is not included here as there were only two scores.|Enrollment was lower than expected and due to the low numbers of subjects completing the study (7 subjects (5 active and 2 placebo) completed all interventions) the numbers were not powerful enough to conduct a full analysis or provide any meaningful statistical analyses. We are including the mean and SD of each arm at the beginning and end of the study only as a comparison and not as a meaningful analysis.|
1694646|NCT01057810|3116355|Superiority or Other||Hazard Ratio (HR)|0.98|||||2-Sided|95.87|0.71|1.35|||||HR = Ipilimumab over placebo||
1694647|NCT01057810|3116356|Superiority or Other||Hazard Ratio (HR)|0.65|||||2-Sided|95.87|0.52|0.83|||||HR = Ipilimumab over placebo||
1694648|NCT01057810|3116357|Superiority or Other||Hazard Ratio (HR)|0.67|||||2-Sided|95.0|0.55|0.8|||||HR = ipilimumab over placebo||
1694649|NCT01057810|3116358|Superiority or Other||Hazard Ratio (HR)|1.11||||0.3667|2-Sided|95.87|0.88|1.39|||Log Rank||Hazard ratio = ipilimumab over placebo||
1694650|NCT01057693|3116385|Superiority or Other||Least Squares Mean Difference|-0.32||||0.1221|2-Sided|95.0|-0.74|0.09|||ANCOVA|||P-value was calculated using analysis of covariance (ANCOVA), with terms for baseline mean pain score, center and treatment in the model.|
1694651|NCT01057589|3116386|Superiority or Other|||||||0.37||||||P-value is for UOS, Maintenance Cycle 7. Threshold for statistical significance was 0.05|t-test, 2 sided||||
1694652|NCT01057589|3116386|Superiority or Other|||||||0.41||||||P-value is for UOS, Maintenance Cycle 5. Threshold for statistical significance was 0.05|t-test, 2 sided||||
1694653|NCT01057589|3116386|Superiority or Other|||||||0.34||||||P-value is for UOS, Maintenance Cycle 3. Threshold for statistical significance was 0.05|t-test, 2 sided||||
1694654|NCT01057589|3116386|Superiority or Other|||||||0.71||||||P-value is for UOS, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694655|NCT01057589|3116386|Superiority or Other|||||||0.03||||||P-value is for UOS, Triplicate Combination Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694656|NCT01057589|3116386|Superiority or Other|||||||0.13||||||P-value is for UOS, Triplicate Combination Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694657|NCT01057589|3116386|Superiority or Other|||||||0.85||||||P-value is for UOS, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694658|NCT01057589|3116386|Superiority or Other|||||||0.21||||||P-value is for EIP, Maintenance Cycle 7. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694659|NCT01057589|3116386|Superiority or Other|||||||0.7||||||P-value is for EIP, Maintenance Cycle 5. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694660|NCT01057589|3116386|Superiority or Other|||||||0.17||||||P-value is for EIP, Maintenance Cycle 3. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694661|NCT01057589|3116386|Superiority or Other|||||||0.29||||||P-value is for EIP, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694664|NCT01057589|3116386|Superiority or Other|||||||0.47||||||P-value is for EIP, Triplicate Combination Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694665|NCT01057589|3116386|Superiority or Other|||||||0.18||||||P-value is for NOD, Maintenance Cycle 7. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694666|NCT01057589|3116386|Superiority or Other|||||||0.36||||||P-value is for NOD, Maintenance Cycle 5. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694667|NCT01057589|3116386|Superiority or Other|||||||0.89||||||P-value is for NOD, Maintenance Cycle 3. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694668|NCT01057589|3116386|Superiority or Other|||||||0.95||||||P-value is for NOD, Maintenance Cycle 1. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694669|NCT01057589|3116386|Superiority or Other|||||||0.49||||||P-value is for NOD, Triplicate Combination Therapy Cycle 6. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694670|NCT01057589|3116386|Superiority or Other|||||||0.31||||||P-value is for NOD, Triplicate Combination Therapy Cycle 4. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694671|NCT01057589|3116386|Superiority or Other|||||||0.9||||||P-value is for NOD, Triplicate Combination Therapy Cycle 2. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694672|NCT01057589|3116387|Superiority or Other|||||||0.788||||||P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694673|NCT01057589|3116387|Superiority or Other|||||||0.223||||||P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694674|NCT01057589|3116388|Superiority or Other|||||||0.132||||||P-value is for Change at End of Maintenance Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694675|NCT01057589|3116388|Superiority or Other|||||||0.697||||||P-value is for Change at End of Triplet Combination Therapy. Threshold for statistical significance was 0.05.|t-test, 2 sided||||
1694676|NCT01057225|3116408|Superiority or Other||Dose Level|1.0|||||2-Sided||||||||Using a cohort of 3 design, it was determined the maximum tolerated dose of carfilzomib is Dose Level 1: 20 mg/m^2 for the first cycle and 36 mg/m^2 for subsequent cycles.||
1694677|NCT01056718|3116443|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694678|NCT01056718|3116444|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694679|NCT01056718|3116445|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694680|NCT01056718|3116446|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694681|NCT01056718|3116447|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694682|NCT01056718|3116448|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694683|NCT01056718|3116449|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694684|NCT01056718|3116450|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694685|NCT01056718|3116451|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694686|NCT01056718|3116452|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694687|NCT01056718|3116453|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694688|NCT01056718|3116454|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694689|NCT01056718|3116455|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694993|NCT01051466|3117073|Superiority or Other|||||||0.797||||||The p-value is for change from baseline cytokine TNFα.|Mixed Models Analysis||||
1694690|NCT01056718|3116456|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694691|NCT01056718|3116457|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694692|NCT01056718|3116458|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694693|NCT01056718|3116459|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694694|NCT01056718|3116460|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694695|NCT01056718|3116461|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694696|NCT01056718|3116462|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694697|NCT01056718|3116463|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694698|NCT01056718|3116464|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694699|NCT01056718|3116465|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694700|NCT01056718|3116466|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694701|NCT01056718|3116467|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.|
1694702|NCT01056718|3116468|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of treatment. Each subject served as his/her own control.|
1694703|NCT01056653|3116469|Superiority or Other|||||||0.121|||||||ANCOVA|F(2,106)=2.158||ANCOVA - Group Comparison of WPL-R scores - Life Change Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.|
1694704|NCT01056653|3116469|Superiority or Other|||||||0.686|||||||ANCOVA|F(2,106)=0.379||ANCOVA - Group Comparison of WPL-R scores - Centrality Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.|
1694705|NCT01056653|3116469|Superiority or Other|||||||0.11|||||||ANCOVA|F(2,106)=2.24.||ANCOVA - Group Comparison of WPL-R scores - Evaluation Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.|
1694706|NCT01056653|3116470|Superiority or Other|||||||0.38|||||||ANCOVA|F(2,107)=0.96||ANCOVA - Group Comparison of Child Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.|
1694707|NCT01056653|3116470|Superiority or Other|||||||0.61|||||||ANCOVA|F(2,107)=0.49||ANCOVA - Group Comparison of Parent Domain scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.|
1694708|NCT01056653|3116471|Superiority or Other|||||||0.732|||||||ANCOVA|F(2,107)=0.313||ANCOVA - Group Comparison of Response to Distress Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.|
1694709|NCT01056653|3116471|Superiority or Other|||||||0.665|||||||ANCOVA|F(2,107)=0.409||ANCOVA - Group Comparison of Sensitivity to Cues Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.|
1694710|NCT01056653|3116471|Superiority or Other|||||||1||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale|
1694711|NCT01056653|3116471|Superiority or Other|||||||0.036||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Socio-Emotional Growth Fostering Subscale|
1694712|NCT01056653|3116471|Superiority or Other|||||||0.036|||||||ANCOVA|F(2,107)=3.440, partial n2=0.060, observed power=0.634||ANCOVA - Group Comparison of Socio-Emotional Growth Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.|
1694713|NCT01056653|3116471|Superiority or Other|||||||0.267||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale|
1694714|NCT01056653|3116471|Superiority or Other|||||||0.056||||||Bonferroni adjustments for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Cognitive Growth Fostering Subscale|
1694715|NCT01056653|3116471|Superiority or Other|||||||0.047|||||||ANCOVA|F(2,107)=3.145, partial n2=0.056, observed power=0.593.||ANCOVA - Group Comparison of Cognitive Growth Fostering Subscale scores at 8 months, controlling for scores at baseline (4 months). Group entered as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.|
1694716|NCT01056653|3116471|Superiority or Other|||||||0.534||||||Bonferroni adjustment for multiple comparisons used|ANCOVA|||Pairwise Group Comparison based on estimated marginal means - Parent Total Scores|
1694717|NCT01056653|3116471|Superiority or Other|||||||0.03||||||Bonferroni adjustments for multiple comparisons used|ANOVA|||Pairwise Group Comparison based on estimated marginal means - Parent Total Scores|
1694718|NCT01056653|3116471|Superiority or Other||||||=|0|||||||ANCOVA|F(2,107)=3.48, partial n2=0.061, observed power=0.639||ANCOVA - Group Comparison of Parent Total Score on PCITS at 8 months, controlling for scores at baseline (4 months). Group entered as as fixed factor, outcome scores as dependent variable, and baseline scores as covariate.|
1694719|NCT01056640|3116472|Superiority or Other||Odds Ratio (OR)|1.31|Standard Error of the Mean|0.2865||0.05|2-Sided|95.0|0.747|2.297|||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test, 2-sample t-test and Chi-square analysis were all used.||All analyses were performed using an intent-to-treat method. Wilcoxon rank sum test, 2-sample t test, or Chi-Square analysis was used to compare baseline characteristics. The primary end points of combined and individual percentages of hospitalizations and ED visits were compared using Chi-Square test. Statistical adjustment was planned only if there were statistical differences in clinical variables between the groups. All tests for significance used a 2-sided P value of .05.|
1694720|NCT01056510|3116485|Superiority or Other||||||<|0.001||||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected||||
1694721|NCT01056510|3116486|Superiority or Other||Hazard Ratio (HR)|0.975||||0.939|2-Sided|95.0|0.505|1.88|||Log Rank|||Stratified analysis: by baseline Binet stage|
1694722|NCT01056510|3116486|Superiority or Other||Hazard Ratio (HR)|0.994||||0.986|2-Sided|95.0|0.517|1.911||Unstratified analysis|Log Rank||||
1694723|NCT01056510|3116488|Superiority or Other|||||||0.007|||||||Log Rank||||
1694724|NCT01056510|3116490|Superiority or Other|||||||0.037|||||||Log Rank||||
1694725|NCT01056510|3116492|Superiority or Other|||||||0.006|||||||Log Rank||||
1694726|NCT01056510|3116494|Superiority or Other|||||||0.029|||||||Log Rank||||
1694727|NCT01056510|3116496|Superiority or Other||Hazard Ratio (HR)|0.523||||0.003|2-Sided|95.0|0.339|0.806|||Log Rank|||Stratified analysis: by baseline Binet stage|
1694728|NCT01056510|3116496|Superiority or Other||Hazard Ratio (HR)|0.525||||0.003|2-Sided|95.0|0.341|0.809|||Log Rank|||Unstratified analysis|
1694729|NCT01056510|3116499|Superiority or Other|||||||0.304||||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||At the EOT visit|
1694730|NCT01056510|3116499|Superiority or Other|||||||0.563||||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||After 6 cycles|
1694731|NCT01056510|3116499|Superiority or Other|||||||0.9||||||Based on two-sided continuity corrected Chi-Square Test|Chi-squared, Corrected|||After 3 cycles|
1694732|NCT01056510|3116500|Superiority or Other|||||||0.009||||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected||||
1694733|NCT01056510|3116501|Superiority or Other||||||<|0.001||||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected||||
1694734|NCT01056510|3116502|Superiority or Other|||||||0.002||||||Based on one-sided continuity corrected Chi-Square Test for participants achieving CR confirmed with biopsy versus those not achieving CR confirmed with biopsy|Chi-squared, Corrected|||The first-line subpopulation became the focus of the primary statistical analysis following the protocol amendment dated 21-May-2012.|
1694735|NCT01056341|3116519|Superiority or Other||||||<|0.0001||||||The methodology used guaranteed that the familywise type I error rate was below the nominal one-sided significance level of 0.005.|combination tests|Superiority was tested using the closed testing procedure and combination tests for all intersection hypotheses using Simes’ adjustment.||"The objective is to test the superiority of the selected arm using the approach of Posch et al.~The primary analysis was performed on the intent-to-treat population: all treated patients in Stage 1 and all treated patients in stage 2 randomized to placebo or the selected arm."|
1694736|NCT01056341|3116520|Superiority or Other||||||<|0.0001||||||"P-value not adjusted for multiplicity. An Independent Committee conducted this analysis to determine the most efficacious of all arms with a good safety profile.~P-value linked to the 3 mg/kg/day 6 months selected arm ."|One-sided Z-tests|One-sided Z-tests for proportions (contrasts tests on placebo) with pooled variance||The interim analysis was carried out after the first 188 patients have completed their W24 visit or been withdrawn prematurely from study therapy. For each propranolol arm, individual hypotheses H0,i: θi≤0|
1694737|NCT01056289|3116543|Non-Inferiority or Equivalence|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was >2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|0.5|||||2-Sided|95.0|-0.88|1.89||||||Difference: Placebo versus DVS SR 25 mg|
1694841|NCT01054820|3116676|Superiority or Other||||||<|0.0001||||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided||||
1694738|NCT01056289|3116543|Non-Inferiority or Equivalence|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was >2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|0.66|||||2-Sided|95.0|-1.03|2.35||||||Difference: DVS SR 25 mg versus DVS SR 50 mg|
1694739|NCT01056289|3116543|Non-Inferiority or Equivalence|Null hypothesis: absolute difference between the 2 discontinuation regimens in DESS total scores was >2.5. Alternative hypothesis: absolute difference was ≤2.5; tested by calculating 95% 2-sided confidence intervals (CIs) on the mean difference between the 2 regimens. If absolute values of both confidence limits were ≤2.5, then the regimens were declared equivalent.|Mean Difference (Final Values)|1.16|||||2-Sided|95.0|-0.51|2.83||||||Difference: Placebo versus DVS SR 50 mg|
1694740|NCT01056263|3116549|Superiority or Other||Five year survival probability|20.6|||||2-Sided|95.0|10.94|32.38||||||Five year survival probability was the probability of survival at 5 year after the date of the start of the study treatment based on the Kaplan-Meier estimate.|
1694741|NCT01056198|3116550|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Paired t-test, 2-sided, alpha = 0.05|
1694742|NCT01056198|3116551|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Paired t-test, 2-sided, alpha = 0.05|
1694743|NCT01056198|3116552|Superiority or Other||||||=|0|||||||ANCOVA|||Null hypothesis: no differences between the 2 treatments with the alternative of non-zero differences. 48 evaluable subjects is sufficient to detect an effect size of 0.80.|
1694744|NCT01056198|3116553|Superiority or Other||||||=|0|||||||ANCOVA|||Null hypothesis: no differences between the 2 treatments with the alternative of non-zero differences. 48 evaluable subjects is sufficient to detect an effect size of 0.80.|
1694745|NCT01056198|3116554|Superiority or Other||||||=|0|||||||ANCOVA|||The BWAT-m scores were compared at each of the 4 treatment weeks and at the end of the follow-up using a mixed-effects ANCOVA for the intent-to-treat population. Treatment and treatment week, as well as their interaction, were defined as fixed effects with subject as a random effect. The BWAT-m score at baseline was used as a covariate.|
1694746|NCT01056107|3116562|Superiority or Other||||||<|0.001|||||||Dunnett's test||||
1694747|NCT01056107|3116562|Superiority or Other||||||<|0.0075|||||||Dunnett's test||||
1694748|NCT01056016|3116565|Superiority or Other||Mean Difference (Net)|32.4|||=|0|2-Sided||||||t-test, 2 sided|||The percentage of patients with whom pediatrician in each group utilized each practice behavior at baseline and 6-months was computed. The reported statistical analysis did not account potential clustering due to the small number of practices in this study.|
1694749|NCT01055769|3116577|Non-Inferiority or Equivalence|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric means ratio|97.65|||||2-Sided|90.0|92.92|102.63||||||Natural log transformed AUCinf of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1694750|NCT01055769|3116578|Non-Inferiority or Equivalence|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric Means Ratio|113.67|||||2-Sided|90.0|105.26|122.75||||||Natural log transformed Cmax of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1694751|NCT01055769|3116579|Non-Inferiority or Equivalence|The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Linezolid 600 mg oral suspension was the Test treatment, while linezolid 600 mg tablet was the Reference treatment.|Adjusted Geometric Means Ratio|97.81|||||2-Sided|90.0|93.11|102.75||||||Natural log transformed AUClast of linezolid was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1694752|NCT01055704|3116580|Superiority or Other||Mean Difference (Final Values)|-0.063|Standard Error of the Mean|0.342||0.855|2-Sided|95.0|-0.756|0.63|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694753|NCT01055704|3116580|Superiority or Other||Mean Difference (Final Values)|-0.497|Standard Error of the Mean|0.374||0.192|2-Sided|95.0|-1.255|0.261|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694754|NCT01055704|3116581|Superiority or Other||Mean Difference (Final Values)|-0.028|Standard Error of the Mean|0.19||0.885|2-Sided|95.0|-0.412|0.357|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694755|NCT01055704|3116581|Superiority or Other||Mean Difference (Final Values)|-0.214|Standard Error of the Mean|0.178||0.236|2-Sided|95.0|-0.572|0.145|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694756|NCT01055704|3116582|Superiority or Other||Mean Difference (Final Values)|12.607|Standard Error of the Mean|11.356||0.274|2-Sided|95.0|-10.362|35.577|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694757|NCT01055704|3116582|Superiority or Other||Mean Difference (Final Values)|1.772|Standard Error of the Mean|12.583||0.889|2-Sided|95.0|-23.678|27.223|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI as covariates|
1694758|NCT01055704|3116583|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|0.448||0.806|2-Sided|95.0|-0.795|1.017|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694759|NCT01055704|3116583|Superiority or Other||Mean Difference (Final Values)|0.728|Standard Error of the Mean|0.497||0.151|2-Sided|95.0|-0.278|1.734|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694760|NCT01055704|3116584|Superiority or Other||Mean Difference (Final Values)|0.098|Standard Error of the Mean|0.19||0.61|2-Sided|95.0|-0.287|0.482|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694761|NCT01055704|3116584|Superiority or Other||Mean Difference (Final Values)|-0.401|Standard Error of the Mean|0.211||0.064|2-Sided|95.0|-0.827|0.025|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694762|NCT01055704|3116585|Superiority or Other||Median Difference (Final Values)|-0.181|Standard Error of the Mean|13.24||0.989|2-Sided|95.0|-26.962|26.598|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694763|NCT01055704|3116585|Superiority or Other||Median Difference (Final Values)|-34.425|Standard Error of the Mean|14.67||0.024|2-Sided|95.0|-64.097|-4.753|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694764|NCT01055704|3116586|Superiority or Other||Mean Difference (Final Values)|-2.28|Standard Error of the Mean|4.208||0.591|2-Sided|95.0|-10.792|6.233|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694765|NCT01055704|3116586|Superiority or Other||Mean Difference (Final Values)|-1.971|Standard Error of the Mean|4.669||0.675|2-Sided|95.0|-11.415|7.472|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694766|NCT01055704|3116587|Superiority or Other||Mean Difference (Final Values)|0.132|Standard Error of the Mean|0.351||0.709|2-Sided|95.0|-0.578|0.841|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694767|NCT01055704|3116587|Superiority or Other||Mean Difference (Final Values)|-0.048|Standard Error of the Mean|0.389||0.902|2-Sided|95.0|-0.835|0.739|||ANCOVA|Error degrees of freedom adjusted for number of missing values imputed.||Data were analyzed using analysis of covariance (ANCOVA) with gender and/or BMI included as covariates.|
1694768|NCT01055639|3116588|Superiority or Other|||||||1|||||||t-test, 2 sided||||
1694769|NCT01055639|3116589|Superiority or Other|||||||0.53|||||||t-test, 2 sided||||
1694770|NCT01055639|3116590|Superiority or Other|||||||0.19|||||||t-test, 2 sided||||
1694771|NCT01055639|3116591|Superiority or Other|||||||0.29|||||||t-test, 2 sided||||
1694772|NCT01055639|3116592|Superiority or Other|||||||0.87|||||||t-test, 2 sided||||
1694773|NCT01055639|3116593|Superiority or Other|||||||0.48|||||||t-test, 2 sided||||
1694774|NCT01055639|3116594|Superiority or Other|||||||0.88|||||||t-test, 2 sided||||
1694775|NCT01055639|3116595|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1694776|NCT01055639|3116596|Superiority or Other|||||||0.12|||||||t-test, 2 sided||||
1694777|NCT01055223|3116630|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Small numbers model didn’t converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694778|NCT01055223|3116630|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn’t converge. Reference group: TZD alone.||
1694779|NCT01055223|3116630|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Small numbers model didn’t converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694780|NCT01055223|3116630|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn’t converge. Reference Group: TZD alone.||
1694781|NCT01055223|3116630|Superiority or Other||Odds Ratio (OR)|1.78|||||2-Sided|95.0|0.03|96.47|||||Adjusted Odds Ratio. Reference group: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosponates.||
1694782|NCT01055223|3116630|Superiority or Other||Odds Ratio (OR)|7.26|||||2-Sided|95.0|0.66|80.35|||||Unadjusted Odds Ratio. Reference group: TZD alone.||
1694783|NCT01055223|3116631|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Small numbers model didn’t converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694784|NCT01055223|3116631|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn’t converge. Reference group: TZD alone.||
1694785|NCT01055223|3116631|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Small numbers model didn’t converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694786|NCT01055223|3116631|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn’t converge. Reference group: TZD alone.||
1694787|NCT01055223|3116631|Superiority or Other||Odds Ratio (OR)|3.19|||||2-Sided|95.0|0.64|15.86|||||Unadjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694788|NCT01055223|3116631|Superiority or Other||Odds Ratio (OR)|5.46|||||2-Sided|95.0|1.53|19.45|||||Unadjusted Odds Ratio. Reference group: TZD alone.||
1696349|NCT01034397|3118728|Superiority or Other|||||||0.001|||||||t-test, 1 sided||||
1694789|NCT01055223|3116632|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Small numbers model didn’t converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates||
1694790|NCT01055223|3116632|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn’t converge. Reference group: TZD alone.||
1694791|NCT01055223|3116632|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Small numbers model didn’t converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694792|NCT01055223|3116632|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn’t converge. Reference group: TZD alone.||
1694793|NCT01055223|3116632|Superiority or Other||Odds Ratio (OR)|0.99|||||2-Sided|95.0|0.62|1.57|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694794|NCT01055223|3116632|Superiority or Other||Odds Ratio (OR)|1.23|||||2-Sided|95.0|0.8|1.88|||||Unadjusted Odds Ratio. Reference group: TZD alone.||
1694795|NCT01055223|3116633|Superiority or Other||Odds Ratio (OR)|1.05|||||2-Sided|95.0|0.09|12.36|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694796|NCT01055223|3116633|Superiority or Other||Odds Ratio (OR)|1.99|||||2-Sided|95.0|0.18|21.93|||||Unadjusted Odds Ratio. Reference group: TZD alone.||
1694797|NCT01055223|3116633|Superiority or Other||Odds Ratio (OR)|0.35|||||2-Sided|95.0|0.08|1.54|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694798|NCT01055223|3116633|Superiority or Other||Odds Ratio (OR)|0.44|||||2-Sided|95.0|0.1|1.9|||||Unadjusted Odds Ratio. Reference group: TZD alone.||
1694799|NCT01055223|3116633|Superiority or Other||Odds Ratio (OR)|1.01|||||2-Sided|95.0|0.71|1.45|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694800|NCT01055223|3116633|Superiority or Other||Odds Ratio (OR)|1.29|||||2-Sided|95.0|0.92|1.79|||||Unadjusted Odds Ratio. Reference Group: TZD alone.||
1694801|NCT01055223|3116634|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Small numbers model didn’t converge. Ref grp: TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694802|NCT01055223|3116634|Superiority or Other||Odds Ratio (OR)|0.0|||||2-Sided|95.0|0.0|0.0|||||Unadjusted Odds Ratio. Small numbers model didn’t converge. Reference group: TZD alone.||
1694803|NCT01055223|3116634|Superiority or Other||Odds Ratio (OR)|1.63|||||2-Sided|95.0|0.7|3.81|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694804|NCT01055223|3116634|Superiority or Other||Odds Ratio (OR)|1.58|||||2-Sided|95.0|0.69|3.6|||||Unadjusted Odds Ratio. Reference group: TZD alone.||
1694805|NCT01055223|3116634|Superiority or Other||Odds Ratio (OR)|1.2|||||2-Sided|95.0|0.88|1.65|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694806|NCT01055223|3116634|Superiority or Other||Odds Ratio (OR)|1.41|||||2-Sided|95.0|1.05|1.89|||||Unadjusted Odds Ratio. Reference group: TZD alone.||
1694807|NCT01055223|3116635|Superiority or Other||Odds Ratio (OR)|1.34|||||2-Sided|95.0|0.12|15.5|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694808|NCT01055223|3116635|Superiority or Other||Odds Ratio (OR)|2.01|||||2-Sided|95.0|0.18|22.14|||||Undadjusted Odds Ratio. Reference Group: TZD alone.||
1694809|NCT01055223|3116635|Superiority or Other||Odds Ratio (OR)|1.46|||||2-Sided|95.0|0.74|2.89|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694810|NCT01055223|3116635|Superiority or Other||Odds Ratio (OR)|1.53|||||2-Sided|95.0|0.78|2.98|||||Unadjusted Odds Ratio. Reference group: TZD alone.||
1694811|NCT01055223|3116635|Superiority or Other||Odds Ratio (OR)|1.19|||||2-Sided|95.0|0.93|1.52|||||Adjusted Odds Ratio. Reference group TZD alone. Adjusted: age, liver disease, angina, renal and heart failure, asthma, stroke, epilepsy, RA, antihypertensives, statins, corticosteroids, antiepileptics, benzodiazepines, HRT, bisphosphonates.||
1694812|NCT01055223|3116635|Superiority or Other||Odds Ratio (OR)|1.42|||||2-Sided|95.0|1.13|1.78|||||Unadjusted Odds Ratio. Reference group: TZD alone.||
1694813|NCT01055197|3116637|Superiority|||||||0.0102|||||||Log Rank|2-sided significance level of 0.05|||
1694814|NCT01055197|3116639|Superiority|||||||0.24|||||||Fisher Exact|2-sided significance level of 0.05|||
1694815|NCT01055197|3116640|Superiority or Other||Hazard Ratio (HR)|1.44||||0.2103|2-Sided|95.0|0.82|2.53|||Log Rank|||The null hypothesis (H0) was that PCI + RT is not effective versus the alternative hypothesis (H1) that PCI + RT is effective. Assumptions were that PCI alone would have hazard rate λc of 1.204 and PCI + RT a hazard rate λc of 0.799 (hazard ratio λt/λc = 0.663). At each planned analysis, the p-value from the log-rank test statistic assessing overall survival was compared to the nominal significance level. The final targeted accrual was 154.|
1694842|NCT01054820|3116677|Superiority or Other||||||<|0.0001||||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided||||
1694816|NCT01055132|3116647|Non-Inferiority or Equivalence|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|least-square mean difference|7.7|Standard Error of the Mean|3.55|||2-Sided|95.0|0.58|14.8|||||Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.|Ho:The test lens is non-inferior to the active comparator lens for overall quality of vision at 1-week follow-up. A non-inferiority margin of -5 units was used.|
1694817|NCT01055132|3116648|Non-Inferiority or Equivalence|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|Least-square mean difference|11.9|Standard Error of the Mean|3.93|||2-Sided|95.0|4.05|19.79|||||Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.|Ho:The test lens is non-inferior to the active comparator lens for comfort at 1-week follow-up. A non-inferiority margin of -5 units was used.|
1694818|NCT01055132|3116649|Non-Inferiority or Equivalence|Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.|Least-square mean difference|-0.015|Standard Error of the Mean|0.0062|||2-Sided|95.0|-0.027|-0.003|||||Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.|Ho:The test lens is non-inferior to the active comparator lens for Binocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.|
1694819|NCT01055132|3116650|Non-Inferiority or Equivalence|Based on historical data, a minimum of 42 subjects is needed to achieve 80% power with 0.05 type I error.|Least-square mean difference|-0.037|Standard Error of the Mean|0.0072|||2-Sided|95.0|-0.041|-0.0013|||||Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference(test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.|Ho:The test lens is non-inferior to the active comparator lens for monocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.|
1694820|NCT01054885|3116667|Superiority or Other||Least squares mean difference|0.032||||0.224|2-Sided|95.0|-0.019|0.083|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694821|NCT01054885|3116667|Superiority or Other||Least squares mean difference|0.045||||0.093|2-Sided|95.0|-0.008|0.097|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694822|NCT01054885|3116667|Superiority or Other||Least squares mean difference|0.123|||<|0.001|2-Sided|95.0|0.072|0.174||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694823|NCT01054885|3116667|Superiority or Other||Least squares mean difference|0.1|||<|0.001|2-Sided|95.0|0.047|0.152||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694824|NCT01054885|3116667|Superiority or Other||Least squares mean difference|0.131|||<|0.001|2-Sided|95.0|0.08|0.183|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694825|NCT01054885|3116667|Superiority or Other||Least squares mean difference|0.144|||<|0.001|2-Sided|95.0|0.091|0.197||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694826|NCT01054885|3116667|Superiority or Other||Least squares mean difference|0.1|||<|0.001|2-Sided|95.0|0.048|0.151|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694827|NCT01054885|3116667|Superiority or Other||Least squares mean difference|0.008|||<|0.756|2-Sided|95.0|-0.044|0.06|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694828|NCT01054885|3116667|Superiority or Other||Least squares mean difference|0.044|||<|0.095|2-Sided|95.0|-0.008|0.097|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694829|NCT01054885|3116668|Superiority or Other||Least squares mean difference|0.024||||0.357|2-Sided|95.0|-0.027|0.075|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694830|NCT01054885|3116668|Superiority or Other||Least squares mean difference|0.029||||0.274|2-Sided|95.0|-0.023|0.081|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694831|NCT01054885|3116668|Superiority or Other||Least squares mean difference|0.168|||<|0.001|2-Sided|95.0|0.117|0.219|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694832|NCT01054885|3116668|Superiority or Other||Least squares mean difference|0.168|||<|0.001|2-Sided|95.0|0.116|0.22||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694833|NCT01054885|3116668|Superiority or Other||Least squares mean difference|0.209|||<|0.001|2-Sided|95.0|0.157|0.261|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694834|NCT01054885|3116668|Superiority or Other||Least squares mean difference|0.214|||<|0.001|2-Sided|95.0|0.161|0.266||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694835|NCT01054885|3116668|Superiority or Other||Least squares mean difference|0.185|||<|0.001|2-Sided|95.0|0.133|0.237|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694836|NCT01054885|3116668|Superiority or Other||Least squares mean difference|0.041|||<|0.123|2-Sided|95.0|-0.011|0.093|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694837|NCT01054885|3116668|Superiority or Other||Least squares mean difference|0.046|||<|0.085|2-Sided|95.0|-0.006|0.098|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694838|NCT01054846|3116670|Superiority or Other||z value|1.351|||>|0.05|2-Sided||||||Chi-squared|||Difference between Survey 1 and Survey 2|
1694839|NCT01054846|3116670|Superiority or Other||z value|2.696|||<|0.01|2-Sided||||||Chi-squared|||Differences between Survey 1 and Survey 2|
1694840|NCT01054820|3116673|Superiority or Other||||||<|0.0001||||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided||||
1694843|NCT01054820|3116678|Superiority or Other||||||<|0.0001||||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided||||
1694844|NCT01054820|3116679|Superiority or Other||||||<|0.0001||||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided||||
1694845|NCT01054820|3116680|Superiority or Other||||||<|0.0001||||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|McNemar||||
1694846|NCT01054820|3116681|Superiority or Other||||||<|0.0001||||||P-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|t-test, 2 sided|||Null hypothesis: no change from baseline. Study powered at 95 percent (%) to detect a mean change of at least 1.2 units, with assumed standard deviation of at most 3.2 units.|
1694847|NCT01054599|3116709|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test||||
1694848|NCT01054599|3116712|Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1694849|NCT01054586|3116720|Superiority or Other||Hazard Ratio (HR)|5.12||||0.03||95.0|1.19|22.02|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."||
1694850|NCT01054586|3116721|Superiority or Other||Hazard Ratio (HR)|2.31||||0.1||95.0|0.85|6.32||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."||
1694851|NCT01054586|3116721|Superiority or Other||Hazard Ratio (HR)|3.61||||0.05||95.0|1.48|8.81||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."||
1694852|NCT01054586|3116721|Superiority or Other||Hazard Ratio (HR)|2.09||||0.03||95.0|1.06|4.15||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, APRI-score, baseline use of non-ARV drug and baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."||
1694853|NCT01054586|3116722|Superiority or Other||Hazard Ratio (HR)|3.07||||0.11||95.0|0.78|12.03||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."||
1694854|NCT01054586|3116722|Superiority or Other||Hazard Ratio (HR)|4.42||||0.0004||95.0|1.61|12.08||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."||
1694855|NCT01054586|3116722|Superiority or Other||Hazard Ratio (HR)|2.68||||0.01||95.0|1.21|5.9||Only variables showing an imbalance between the treatment groups were included: gender, mode of HIV transmission, ART naive, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."||
1694856|NCT01054586|3116723|Superiority or Other||Hazard Ratio (HR)|3.67||||0.06||95.0|0.97|13.9||Only variables showing an imbalance between the treatment groups were included, but p > .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."||
1694857|NCT01054586|3116723|Superiority or Other||Hazard Ratio (HR)|4.17||||0.05||95.0|1.54|11.27||Only variables showing an imbalance between the treatment groups were included, but p > .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."||
1694858|NCT01054586|3116723|Superiority or Other||Hazard Ratio (HR)|2.53||||0.02||95.0|1.16|5.54||Only variables showing an imbalance between the treatment groups were included, but p > .05: gender, mode of HIV transmission, ART naive, APRI score, baseline use of non-ARV drug, and baseline values of CD4, platelets and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."||
1694859|NCT01054586|3116724|Superiority or Other||Hazard Ratio (HR)|3.77||||0.1||95.0|0.79|18.05|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."||
1694860|NCT01054586|3116730|Superiority or Other||Hazard Ratio (HR)|2.26||||0.15||95.0|0.74|6.97|||Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV, other. LPV is the reference group."|Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.|
1694861|NCT01054586|3116730|Superiority or Other||Hazard Ratio (HR)|0.27||||0.21||95.0|0.03|2.08||Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."||
1694862|NCT01054586|3116730|Superiority or Other||Hazard Ratio (HR)|1.16||||0.72||95.0|0.51|2.66||Only variables showing an imbalance between treatment groups were included: gender, mode of HIV transmission, ART naive, use of non-ARV drug, baseline bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for  FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."||
1694863|NCT01054586|3116732|Superiority or Other||Hazard Ratio (HR)|1.67||||0.56||95.0|0.29|9.47||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p > 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV, Other. LPV is the reference group."||
1694884|NCT01053988|3116832|Superiority or Other||Least squares mean difference|0.033|||<|0.241|2-Sided|95.0|-0.022|0.088|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694864|NCT01054586|3116732|Superiority or Other||Hazard Ratio (HR)|0.26||||0.23||95.0|0.03|2.18||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p > 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."||
1694865|NCT01054586|3116732|Superiority or Other||Hazard Ratio (HR)|1.4||||0.48||95.0|0.55|3.55||Only variables showing imbalance between treatments (when possible) were included. The following were also included, but p > 0.05: gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."||
1694866|NCT01054586|3116733|Superiority or Other||Hazard Ratio (HR)|1.86||||0.47||95.0|0.35|9.91||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV, Other. LPV is the reference group."||
1694867|NCT01054586|3116733|Superiority or Other||Hazard Ratio (HR)|0.28||||0.22||95.0|0.04|2.14||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."||
1694868|NCT01054586|3116733|Superiority or Other||Hazard Ratio (HR)|1.31||||0.57||95.0|0.52|3.31||Variables showing imbalance between treatments (when possible and besides APRI score) were included. Gender, mode of HIV transmission, ART naive, APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin were also included, but p>0.05.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."||
1694869|NCT01054586|3116734|Superiority or Other||Hazard Ratio (HR)|1.06||||0.96||95.0|0.11|9.83||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."||
1694870|NCT01054586|3116734|Superiority or Other||Hazard Ratio (HR)|3.2||||0.06||95.0|0.94|10.82||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."||
1694871|NCT01054586|3116735|Superiority or Other||Hazard Ratio (HR)|1.26||||0.85||95.0|0.12|13.33||Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."||
1694872|NCT01054586|3116735|Superiority or Other||Hazard Ratio (HR)|2.83||||0.17||95.0|0.65|12.36||Only variables showing an imbalance between the treatment groups (when possible) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."||
1694873|NCT01054586|3116736|Superiority or Other||Hazard Ratio (HR)|1.62||||0.68||95.0|0.16|16.27||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg QD. LPV is the reference group."||
1694874|NCT01054586|3116736|Superiority or Other||Hazard Ratio (HR)|4.12||||0.05||95.0|1.03|16.5||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for FPV 700 mg BID/RTV 100 mg BID. LPV is the reference group."||
1694875|NCT01054586|3116737|Superiority or Other||Hazard Ratio (HR)|6.1||||0.02||95.0|1.26|29.46||Only variables showing an imbalance between the treatment groups (when possible and besides APRI score) were included. The following were also included, but p > 0.05: APRI score, use of non-ARV drug, baseline CD4, platelets, and bilirubin.|Regression, Cox||"Confidence Interval and Hazard Ratio for ART naïve. Not ART naïve is the reference group."||
1694876|NCT01054183|3116798|Non-Inferiority or Equivalence|powered for 62 patients||||||0.002|||||||z test, two-sided|||Null hypothesis: overall successful intubation rate is the same for both groups.|
1694877|NCT01054183|3116799|Non-Inferiority or Equivalence|powered for 62 patients||||||0.57|||||||z test, two-sided|||Null hypothesis: the proportion of successful 1st intubation attempt is the same for both groups|
1694878|NCT01053988|3116832|Superiority or Other||Least squares mean difference|0.048||||0.082|2-Sided|95.0|-0.006|0.102|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694879|NCT01053988|3116832|Superiority or Other||Least squares mean difference|0.062||||0.025|2-Sided|95.0|0.008|0.117||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694880|NCT01053988|3116832|Superiority or Other||Least squares mean difference|0.082||||0.003|2-Sided|95.0|0.028|0.136||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694881|NCT01053988|3116832|Superiority or Other||Least squares mean difference|0.115|||<|0.001|2-Sided|95.0|0.06|0.169|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694882|NCT01053988|3116832|Superiority or Other||Least squares mean difference|0.129|||<|0.001|2-Sided|95.0|0.074|0.184||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694883|NCT01053988|3116832|Superiority or Other||Least squares mean difference|0.067|||<|0.017|2-Sided|95.0|0.012|0.121|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694885|NCT01053988|3116833|Superiority or Other||Least squares mean difference|0.071||||0.006|2-Sided|95.0|0.021|0.121||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694886|NCT01053988|3116833|Superiority or Other||Least squares mean difference|0.09|||<|0.001|2-Sided|95.0|0.039|0.14||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694887|NCT01053988|3116833|Superiority or Other||Least squares mean difference|0.12|||<|0.001|2-Sided|95.0|0.07|0.17|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694888|NCT01053988|3116833|Superiority or Other||Least squares mean difference|0.173|||<|0.001|2-Sided|95.0|0.123|0.224|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694889|NCT01053988|3116833|Superiority or Other||Least squares mean difference|0.192|||<|0.001|2-Sided|95.0|0.141|0.243||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694890|NCT01053988|3116833|Superiority or Other||Least squares mean difference|0.103|||<|0.001|2-Sided|95.0|0.052|0.153|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694891|NCT01053988|3116833|Superiority or Other||Least squares mean difference|0.053|||<|0.04|2-Sided|95.0|0.003|0.104||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1694892|NCT01053741|3116845|Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is that there is no difference in epithelial surface disruption when comparing the two interventions. Power calculation was based on identifying a median difference in histology grade of 0.83, using a two-sided alpha of 0.05 with 90% power in 10 subjects.|
1694893|NCT01053312|3116868|Non-Inferiority or Equivalence|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.685||||0.099|||||||Regression, Linear|||Composite Region|
1694894|NCT01053312|3116868|Non-Inferiority or Equivalence|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.482||||0.268|||||||Regression, Linear|||Ipsilateral to the biopsy Site|
1694895|NCT01053312|3116868|Non-Inferiority or Equivalence|The level of association between SUVR and the amyloid levels was analyzed using a regression model.|R²|0.688||||0.098|2-Sided||||||Regression, Linear|||Contralateral to the biopsy Site|
1694896|NCT01052844|3116896|Superiority or Other|||||||0.06|||||||Chi-squared|||We evaluated associations between categorical variables using the Chi-Square test|
1694897|NCT01052844|3116897|Superiority or Other|||||||0.04|||||||Chi-squared|||Complete protection from nausea and vomiting (CP) was defined as the absence of any episode of nausea or vomiting and no use of rescue medication. CP was further defined as either acute (ACP), when occurring during the first 24 hours after chemotherapy; delayed (DCP), when occurring during the period from days 2 through 5 after chemotherapy; or overall, when occurring over the entire period of the study (first 120 hours).|
1694898|NCT01052779|3116901|Non-Inferiority|Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.|Treatment Difference|0.09||||0.587|2-Sided|95.0|-0.23|0.41||The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.|ANOVA||The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.|Without Imputation (Sensitivity Analysis): The p-value and two-sided 95% CI for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an ANOVA model adjusted for baseline hemoglobin level and hemodialysis status.|
1694899|NCT01052779|3116901|Non-Inferiority|Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.|Treatment Difference|0.1||||0.515|2-Sided|95.0|-0.21|0.41||The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.|ANOVA||The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.|With LOCF Imputation: The p-value and two-sided 95% confidence interval (CI) for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an analysis of variance (ANOVA) model adjusted for baseline hemoglobin level and hemodialysis status.|
1694900|NCT01052714|3116902|Superiority|||||||0.763|||||||Mixed Models Analysis||||
1694901|NCT01052714|3116903|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1694902|NCT01052714|3116904|Superiority|||||||0.146|||||||Mixed Models Analysis||||
1694903|NCT01052714|3116905|Superiority|||||||0.79|||||||Mixed Models Analysis||||
1694904|NCT01052714|3116906|Superiority|||||||0.059|||||||Mixed Models Analysis||||
1694905|NCT01052714|3116907|Superiority|||||||0.22|||||||Mixed Models Analysis||||
1694906|NCT01052714|3116908|Superiority|||||||0.687|||||||Mixed Models Analysis||||
1694907|NCT01052714|3116909|Superiority|||||||0.415|||||||Mixed Models Analysis||||
1694908|NCT01052714|3116910|Superiority|||||||0.9|||||||Mixed Models Analysis||||
1694909|NCT01052714|3116911|Superiority|||||||0.663|||||||Mixed Models Analysis||||
1694910|NCT01052714|3116912|Superiority|||||||0.652|||||||Mixed Models Analysis||||
1694911|NCT01052714|3116913|Superiority|||||||0.322|||||||Mixed Models Analysis||||
1694912|NCT01052714|3116914|Superiority|||||||0.92|||||||Mixed Models Analysis||||
1694913|NCT01052714|3116915|Superiority|||||||0.141|||||||Mixed Models Analysis||||
1694914|NCT01052714|3116916|Superiority|||||||0.676|||||||Mixed Models Analysis||||
1694915|NCT01052714|3116917|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1694916|NCT01052714|3116918|Superiority|||||||0.718|||||||Mixed Models Analysis||||
1694917|NCT01052714|3116919|Superiority||||||<|0.001|||||||Mixed Models Analysis||||
1694918|NCT01052662|3116922|Superiority or Other||Cox Proportional Hazard|2.4||||1.2|2-Sided|||||These results are using survival curve estimates to first positive urine toxicology for any opioid. The last observation carried forward (LOCF) was used to perform our survival event analyses.|Log Rank||||
1694919|NCT01052662|3116923|Superiority or Other||Hazard Ratio, log|0.87||||0.64|2-Sided||||||Log Rank||||
1696350|NCT01034397|3118730|Superiority or Other|||||||0.067|||||||t-test, 1 sided||||
1694920|NCT01052662|3116924|Superiority or Other||Slope|-0.00935|Standard Error of the Mean|0.00356|=|0|2-Sided||||||Mixed Models Analysis||Z = -2.62209|We modeled the mean proportion of weekly opioid use using a mixed-effect linear regression approach to assess the treatment effect, the time effect and the interaction of time x treatment effect while adjusting for the baseline mean proportion of weekly opioid use with baseline COWS, Addiction Severity Index (ASI) psychiatric and legal composite scores as covariates.|
1694921|NCT01052545|3116925|Superiority or Other||||||<|0.05||||||We used χ2 test, Fisher’s exact test and one-way ANOVA to determine if patient-level covariates differed between the baseline, intervention and maintenance periods at each study site.|Regression, Logistic||||
1694922|NCT01052545|3116931|Superiority or Other||||||<|0.05||||||Descriptive statistics were used to estimate the incidence rates per 1,000 bed-days and 95% confidence intervals (CI) for urine cultures ordered, ASB overtreatment and CAUTI under-treatment in each study period.|Regression, Logistic|to test whether there was a significant difference in monthly urine cultures ordered between the two study sites over time.|||
1694923|NCT01052480|3116954|Superiority or Other|||||||0.069|||||||Log Rank||||
1694924|NCT01052428|3116955|Superiority or Other|||||||0.001||||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)|
1694925|NCT01052428|3116956|Superiority or Other|||||||0.16||||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)|
1694926|NCT01052428|3116957|Superiority or Other|||||||0.006||||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)|
1694927|NCT01052428|3116958|Superiority or Other|||||||0.21||||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)|
1694928|NCT01052428|3116959|Superiority or Other|||||||0.55||||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)|
1694929|NCT01052428|3116960|Superiority or Other|||||||0.1967||||||not adjusted for multiple comparisons|Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)|
1694930|NCT01052428|3116961|Superiority or Other|||||||0.4568|||||||Mixed Models Analysis|||The differences in the rate of progression of the outcome measures were the focus of the comparisons over time between the treatment groups. A significant interaction effect between time and treatment group in the mixed model is the measure of treatment effect. Since some visits did not occur at the scheduled 6 month intervals, the results have been divided into 3-month visit intervals for reporting purposes and the number of Participants for each interval is indicated as (n=x,y)|
1694931|NCT01052077|3116973|Superiority or Other||Ratio of Response Rate|1.15||||0.2345|2-Sided|95.0|0.91|1.44||CMH general association test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 14|
1694932|NCT01052077|3116973|Superiority or Other||Ratio of Response Rate|1.26||||0.0417|2-Sided|95.0|1.01|1.58|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 13|
1694933|NCT01052077|3116973|Superiority or Other||Ratio of Response Rate|1.36||||0.0105|2-Sided|95.0|1.08|1.71|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 12|
1694934|NCT01052077|3116973|Superiority or Other||Ratio of Response Rate|1.37||||0.023|2-Sided|95.0|1.05|1.8|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 11|
1694935|NCT01052077|3116973|Superiority or Other||Ratio of Response Rate|1.2||||0.3267|2-Sided|95.0|0.83|1.72|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 10|
1694936|NCT01052077|3116973|Superiority or Other||Ratio of Response Rate|1.23||||0.4605|2-Sided|95.0|0.7|2.18|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center.||Week 9|
1694937|NCT01052077|3116974|Superiority or Other||Ratio of Remission Rate|1.71||||0.0089|2-Sided|95.0|1.14|2.57||The CMH general association test controlling for trial center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 14|
1694938|NCT01052077|3116974|Superiority or Other||Ratio of Response Rate|1.77||||0.0068|2-Sided|95.0|1.17|2.67|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 13|
1694939|NCT01052077|3116974|Superiority or Other||Ratio of Remission Rate|2.12||||0.0019|2-Sided|95.0|1.31|3.46|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 12|
1694940|NCT01052077|3116974|Superiority or Other||Ratio of Remission Rate|1.67||||0.0496|2-Sided|95.0|0.99|2.82|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 11|
1694941|NCT01052077|3116974|Superiority or Other||Ratio of Remission Rate|2.04||||0.0983|2-Sided|95.0|0.83|4.98|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 10|
1694942|NCT01052077|3116974|Superiority or Other||Ratio of Remission Rate|2.27||||0.2404|2-Sided|95.0|0.55|9.3|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 9|
1694943|NCT01052077|3116975|Superiority or Other||Ratio of Response Rate|1.47||||0.0339|2-Sided|95.0|1.03|2.08|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 14|
1694944|NCT01052077|3116975|Superiority or Other||Ratio of Response Rate|1.64||||0.0074|2-Sided|95.0|1.14|2.38|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 13|
1694945|NCT01052077|3116975|Superiority or Other||Ratio of Response Rate|1.93||||0.0008|2-Sided|95.0|1.31|2.86|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 12|
1694946|NCT01052077|3116975|Superiority or Other||Ratio of Response Rate|1.53||||0.0521|2-Sided|95.0|0.99|2.35|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 11|
1694947|NCT01052077|3116975|Superiority or Other||Ratio of Response Rate|1.78||||0.036|2-Sided|95.0|1.01|3.14|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 10|
1694948|NCT01052077|3116975|Superiority or Other||Ratio of Response rate|2.79||||0.0679|2-Sided|95.0|0.88|8.81|||Cochran-Mantel-Haenszel|The CMH general association test controlling for trial center.||Week 9|
1694949|NCT01052077|3116976|Superiority or Other|||||||0.3438||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 14|
1694950|NCT01052077|3116976|Superiority or Other|||||||0.0711||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 13|
1694951|NCT01052077|3116976|Superiority or Other|||||||0.0137||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 12|
1694952|NCT01052077|3116976|Superiority or Other|||||||0.0501||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 11|
1694953|NCT01052077|3116976|Superiority or Other|||||||0.19||||||CMH row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 10|
1694954|NCT01052077|3116976|Superiority or Other|||||||0.5616||||||Cohran-Mantel-Haenszel (CMH) row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|Treatment difference = difference in adjusted mean: brexpiprazole − placebo.||Week 9|
1694955|NCT01052077|3116977|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.3247|2-Sided|95.0|-1.71|0.57||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 14|
1694956|NCT01052077|3116978|Superiority or Other||Mean Difference (Final Values)|0.14||||0.8918|2-Sided|95.0|-1.89|2.17||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 14|
1694957|NCT01052077|3116978|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.9893|2-Sided|95.0|-1.91|1.88||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 13|
1694958|NCT01052077|3116978|Superiority or Other||Mean Difference (Final Values)|0.06||||0.9459|2-Sided|95.0|-1.94|1.81||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 12|
1694959|NCT01052077|3116978|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.749|2-Sided|95.0|-2.0|1.44||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 11|
1694960|NCT01052077|3116978|Superiority or Other||Mean Difference (Final Values)|0.03||||0.9697|2-Sided|95.0|-1.48|1.54||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo||Week 10|
1694961|NCT01052077|3116978|Superiority or Other||Mean Difference (Final Values)|0.34||||0.6272|2-Sided|95.0|-1.02|1.69||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 9|
1694962|NCT01052077|3116979|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.3318|2-Sided|95.0|-0.29|0.1||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 14|
1694963|NCT01052077|3116979|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.0572|2-Sided|95.0|-0.38|0.01||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 13|
1694964|NCT01052077|3116979|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.0061|2-Sided|95.0|-0.45|-0.08||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 12|
1694965|NCT01052077|3116979|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.0457|2-Sided|95.0|-0.35|0.0||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 11|
1694966|NCT01052077|3116979|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.0691|2-Sided|95.0|-0.28|0.01||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 10|
1694967|NCT01052077|3116979|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.1481|2-Sided|95.0|-0.21|0.03||ANCOVA model, with treatment and study center as main effects and Week 8 value as covariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 9|
1694968|NCT01052077|3116980|Superiority or Other||Mean Difference (Final Values)|-1.18||||0.1416|2-Sided|95.0|-2.75|0.39||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 14|
1694969|NCT01052077|3116980|Superiority or Other||Mean Difference (Final Values)|-1.82||||0.0174|2-Sided|95.0|-3.32|-0.32||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 13|
1694970|NCT01052077|3116980|Superiority or Other||Mean Difference (Final Values)|-2.21||||0.0038|2-Sided|95.0|-3.69|-0.72||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 12|
1694971|NCT01052077|3116980|Superiority or Other||Mean Difference (Final Values)|-2.01||||0.0061|2-Sided|95.0|-3.44|-0.58||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 11|
1694972|NCT01052077|3116980|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.0031|2-Sided|95.0|-3.15|-0.65||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 10|
1694973|NCT01052077|3116980|Superiority or Other||Mean Difference (Final Values)|-1.31||||0.0162|2-Sided|95.0|-2.38|-0.24||ANCOVA model, with treatment and trial center as main effects and Week 8 value as covariate, was used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 9|
1694974|NCT01052077|3116981|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.3778|2-Sided|95.0|-0.69|0.26||ANCOVA model, with treatment and study center as main effects and Week 8 value as covariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 14|
1694975|NCT01052077|3116982|Superiority or Other||Mean Difference (Final Values)|-1.18||||0.1416|2-Sided|95.0|-2.75|0.39||ANCOVA model, with treatment and study center as main effects and Week 8 value as convariate, is used for change from Week 8 comparisons.|ANCOVA|Treatment difference = difference in adjusted mean change: brexpiprazole − placebo.||Week 14|
1694976|NCT01052038|3116983|Superiority or Other|||||||0.04|||||||Chi-squared, Corrected||||
1694977|NCT01052038|3116984|Superiority or Other||Median Difference (Net)|10.0||||0.003||95.0|0.0|20.0|||Wilcoxon (Mann-Whitney)||||
1694978|NCT01052038|3116984|Superiority or Other|||||||0.01|||||||Kruskal-Wallis|Post hoc test using Dunn's test corrected for 12 comparisons|||
1694979|NCT01052038|3116985|Superiority or Other|||||||0.004|||||||Chi-squared, Corrected||||
1694980|NCT01052038|3116986|Superiority or Other||Median Difference (Net)|14.0||||0.004|2-Sided|95.0|7.0|22.0|||Wilcoxon (Mann-Whitney)||||
1694981|NCT01052038|3116986|Superiority or Other||Median Difference (Net)|22.0||||0.005|2-Sided|95.0|14.0|29.0|||Wilcoxon (Mann-Whitney)||||
1694982|NCT01052038|3116986|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|Dunn's post hoc-test corrected for 12 comparisons.|||
1694983|NCT01052038|3116987|Superiority or Other||Median Difference (Net)|1.0|||<|0.001|2-Sided|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)||||
1694984|NCT01052038|3116987|Superiority or Other||Median Difference (Net)|1.0|||<|0.001|2-Sided|95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)||||
1694985|NCT01052038|3116987|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis||||
1694986|NCT01051856|3116996|Superiority or Other|||||||0.35|||||||Chi-squared||||
1694987|NCT01051739|3117011|Superiority or Other|||||||0.21||||||The a priori threshold of statistical significance is p<0.05|Kaplan Meyer survival curves||||
1694988|NCT01051661|3117022|Other||Adjusted GMT ratios|1.05|||||2-Sided|95.0|0.93|1.19||||||Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 1D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 1D Group/GSK2340273A Group).|
1694989|NCT01051661|3117022|Other||Adjusted GMT ratios|5.61|||||2-Sided|95.0|4.92|6.41||||||Adjusted Geometric mean titer (GMT) ratios of Hemagglutination Inhibition (HI) antibody post vaccination between Arepanrix 2D Group and GSK2340273A Group for A/California influenza strain (Arepanrix 2D Group/GSK2340273A Group).|
1694990|NCT01051661|3117050|Superiority|The non-inferiority objective was met if the lower limit (LL) of the 95% CI for the Vaccine Efficacy Improvement (VEI) was > -33%. Furthermore, the superiority objective was met if the LL of the 95% CI for the VEI was >0.|Vaccine efficacy increase|76.7|||||2-Sided|95.0|18.53|93.39||||||Evaluation of the relative protective efficacy of 2 doses of Arepanrix™ vaccine (Arepanrix 2D Group) compared to two doses of GSK2340273A vaccine (GSK2340273A Group) beginning 14 days after Dose 1 vaccination (for each subject enrolled) and continuing until study conclusion on Day 385.|
1694991|NCT01051466|3117073|Superiority or Other|||||||0.925||||||The p-value is for change from baseline cytokine IL-6.|Mixed Models Analysis||||
1694992|NCT01051466|3117073|Superiority or Other|||||||0.269||||||The p-value is for change from baseline cytokine IL-1.|Mixed Models Analysis||||
1696351|NCT01034397|3118733|Superiority or Other||||||<|0.001|||||||t-test, 1 sided||||
1694994|NCT01051466|3117074|Superiority or Other|||||||0.273||||||The p-value is for change from baseline trkB.|Mixed Models Analysis||||
1694995|NCT01051466|3117075|Superiority or Other|||||||0.819||||||The p-value is for change from baseline proBDNF.|Mixed Models Analysis||||
1694996|NCT01051466|3117075|Superiority or Other|||||||0.904||||||The p-value is for change from baseline BDNF.|Mixed Models Analysis||||
1694997|NCT01051466|3117077|Superiority or Other|||||||0.276||||||The p-value is for Gsα translocation in platelets at Week 12.|Mixed Models Analysis||||
1694998|NCT01051466|3117077|Superiority or Other|||||||0.697||||||The p-value is for Gsα translocation in platelets at Week 8.|Mixed Models Analysis||||
1694999|NCT01051466|3117077|Superiority or Other|||||||0.925||||||The p-value is for Gsα translocation in platelets at Week 1.|Mixed Models Analysis||||
1695000|NCT01051466|3117077|Superiority or Other|||||||0.48||||||The p-value is for Gsα translocation in RBCs at Week 12.|Mixed Models Analysis||||
1695001|NCT01051466|3117077|Superiority or Other|||||||0.488||||||The p-value is for Gsα translocation in RBCs at Week 8.|Mixed Models Analysis||||
1695002|NCT01051466|3117077|Superiority or Other|||||||0.174||||||The p-value is for Gsα translocation in RBCs at Week 1.|Mixed Models Analysis||||
1695003|NCT01051466|3117078|Superiority or Other|||||||0.191||||||The p-value is for change from baseline volume in the right hippocampus.|Mixed Models Analysis||||
1695004|NCT01051466|3117078|Superiority or Other|||||||0.35||||||The p-value is for change from baseline volume in the left hippocampus.|Mixed Models Analysis||||
1695005|NCT01051466|3117078|Superiority or Other|||||||0.031||||||The p-value is for change from baseline volume in the right amygdalae.|Mixed Models Analysis||||
1695006|NCT01051466|3117078|Superiority or Other|||||||0.208||||||The p-value is for change from baseline volume in the left amygdalae.|Mixed Models Analysis||||
1695007|NCT01051466|3117078|Superiority or Other|||||||0.03||||||The p-value is for change from baseline volume in the subgenual anterior cingulate.|Mixed Models Analysis||||
1695008|NCT01051466|3117079|Superiority or Other|||||||0.518||||||The p-value is for change from baseline activation (BOLD response) in the right amygdala.|Mixed Models Analysis||||
1695009|NCT01051466|3117079|Superiority or Other|||||||0.338||||||The p-value is for change from baseline activation (BOLD response) in the left amygdala.|Mixed Models Analysis||||
1695010|NCT01051466|3117079|Superiority or Other|||||||0.627||||||The p-value is for change from baseline activation (BOLD response) in the anterior cingulate.|Mixed Models Analysis||||
1695011|NCT01051466|3117080|Superiority or Other|||||||0.457||||||The significance level was 0.05 for a 2-sided test.|Mixed Models Analysis||||
1695012|NCT01050998|3117157|Superiority or Other||Adjusted mean difference|36.11|Standard Error of the Mean|17.089||0.041|2-Sided|95.0|1.58|70.63|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for Japanese region.|
1695013|NCT01050998|3117157|Superiority or Other||Adjusted mean difference|4.22|Standard Error of the Mean|17.872||0.815|2-Sided|95.0|-31.89|40.32|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for Japanese region.|
1695014|NCT01050998|3117157|Superiority or Other||Adjusted mean difference|31.24|Standard Error of the Mean|17.089||0.075|2-Sided|95.0|-3.28|65.77|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for Japanese region.|
1695015|NCT01050998|3117157|Superiority or Other||Adjusted mean difference|12.11|Standard Error of the Mean|17.089||0.483|2-Sided|95.0|-22.41|46.64|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for Japanese region.|
1695016|NCT01050998|3117157|Superiority or Other||Adjusted mean difference|31.37|Standard Error of the Mean|7.873|<|0.001|2-Sided|95.0|15.85|46.89|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for European region.|
1695017|NCT01050998|3117157|Superiority or Other||Adjusted mean difference|7.84|Standard Error of the Mean|7.873|<|0.32|2-Sided|95.0|-7.68|23.36|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for European region.|
1695018|NCT01050998|3117157|Superiority or Other||Adjusted mean difference|19.43|Standard Error of the Mean|7.798|<|0.013|2-Sided|95.0|4.06|34.8|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for European region.|
1695019|NCT01050998|3117157|Superiority or Other||Adjusted Mean difference|14.49|Standard Error of the Mean|7.981|<|0.071|2-Sided|95.0|-1.24|30.22|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for European region.|
1695020|NCT01050998|3117158|Superiority or Other||Adjusted Mean difference|32.03|Standard Error of the Mean|7.085|<|0.001|2-Sided|95.0|18.08|45.98|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.||
1695021|NCT01050998|3117158|Superiority or Other||Adjusted Mean difference|7.09|Standard Error of the Mean|7.136|<|0.322|2-Sided|95.0|-6.96|21.14|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.||
1695022|NCT01050998|3117158|Superiority or Other||Adjusted Mean difference|21.23|Standard Error of the Mean|7.028|<|0.003|2-Sided|95.0|7.39|35.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.||
1695023|NCT01050998|3117158|Superiority or Other||Adjusted Mean difference|14.05|Standard Error of the Mean|7.162|<|0.051|2-Sided|95.0|-0.05|28.15|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.||
1695024|NCT01050998|3117160|Superiority or Other||Percent difference|-11.8||||1|2-Sided|95.0|-37.5|22.6|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695025|NCT01050998|3117160|Superiority or Other||Percent difference|0.7||||1|2-Sided|95.0|-26.7|39.5|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695026|NCT01050998|3117160|Superiority or Other||Percent difference|-11.8||||0.529|2-Sided|95.0|-35.0|22.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR70 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695027|NCT01050998|3117160|Superiority or Other||Percent difference|13.9||||0.03|2-Sided|95.0|2.7|29.5|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695028|NCT01050998|3117160|Superiority or Other||Percent difference|3.7||||0.41|2-Sided|95.0|-5.1|16.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695029|NCT01050998|3117160|Superiority or Other||Percent difference|5.8||||0.242|2-Sided|95.0|-3.7|19.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695030|NCT01050998|3117160|Superiority or Other||Percent difference|1.1||||1|2-Sided|95.0|-7.0|14.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR70 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695031|NCT01050998|3117160|Superiority or Other||Percent difference|38.2||||0.059|2-Sided|95.0|1.6|71.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695032|NCT01050998|3117160|Superiority or Other||Percent difference|-11.8||||0.529|2-Sided|95.0|-35.0|22.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695033|NCT01050998|3117160|Superiority or Other||Percent difference|25.7||||0.283|2-Sided|95.0|-8.8|63.2|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695034|NCT01050998|3117160|Superiority or Other||Percent difference|-0.7||||1|2-Sided|95.0|-27.0|34.8|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR50 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695035|NCT01050998|3117160|Superiority or Other||Percent difference|18.8||||0.021|2-Sided|95.0|3.4|36.0|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695036|NCT01050998|3117160|Superiority or Other||Percent difference|8.5||||0.271|2-Sided|95.0|-5.1|24.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695037|NCT01050998|3117160|Superiority or Other||Percent difference|17.3||||0.026|2-Sided|95.0|2.4|34.1|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695038|NCT01050998|3117160|Superiority or Other||Percent difference|11.1||||0.175|2-Sided|95.0|-2.9|27.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR50 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695039|NCT01050998|3117160|Superiority or Other||Percent difference|51.5||||0.028|2-Sided|95.0|8.2|77.0|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695040|NCT01050998|3117160|Superiority or Other||Percent difference|-1.3||||1|2-Sided|95.0|-33.7|35.7|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695041|NCT01050998|3117160|Superiority or Other||Percent difference|39.0||||0.087|2-Sided|95.0|-2.7|69.6|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695042|NCT01050998|3117160|Superiority or Other||Percent difference|20.9||||0.382|2-Sided|95.0|-16.4|55.9|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region: ACR20 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695043|NCT01050998|3117160|Superiority or Other||Percent difference|29.2||||0.005|2-Sided|95.0|9.7|46.1|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695044|NCT01050998|3117160|Superiority or Other||Percent difference|1.0||||1|2-Sided|95.0|-17.7|20.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695045|NCT01050998|3117160|Superiority or Other||Percent difference|16.1||||0.12|2-Sided|95.0|-3.1|34.4|||Fisher Exact|p-value was calculated using a two-tailed Fisher’s exact test.|95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695046|NCT01050998|3117160|Superiority or Other||Percent difference|1.0||||1|2-Sided|95.0|-17.7|20.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region: ACR20 - p-value was calculated using a two-tailed Fisher’s exact test.|
1695047|NCT01050998|3117161|Superiority or Other||Percent difference|9.5||||0.106|2-Sided|95.0|-0.5|23.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher’s exact test.|
1695048|NCT01050998|3117161|Superiority or Other||Percent difference|0.8||||1|2-Sided|95.0|-7.2|12.1|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher’s exact test.|
1695049|NCT01050998|3117161|Superiority or Other||Percent difference|4.8||||0.317|2-Sided|95.0|-4.1|17.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher’s exact test.|
1695050|NCT01050998|3117161|Superiority or Other||Percent difference|-1.3||||1|2-Sided|95.0|-8.9|9.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR70: p-value was calculated using a two-tailed Fisher’s exact test.|
1695051|NCT01050998|3117161|Superiority or Other||Percent difference|22.1||||0.003|2-Sided|95.0|7.6|37.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher’s exact test.|
1695052|NCT01050998|3117161|Superiority or Other||Percent difference|4.7||||0.446|2-Sided|95.0|-7.0|19.1|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher’s exact test.|
1695053|NCT01050998|3117161|Superiority or Other||Percent difference|18.7||||0.011|2-Sided|95.0|4.8|34.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher’s exact test.|
1695054|NCT01050998|3117161|Superiority or Other||Percent difference|8.9||||0.212|2-Sided|95.0|-3.5|23.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR50: p-value was calculated using a two-tailed Fisher’s exact test.|
1695055|NCT01050998|3117161|Superiority or Other||Percent difference|33.3|||<|0.001|2-Sided|95.0|15.6|48.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher’s exact test.|
1695056|NCT01050998|3117161|Superiority or Other||Percent difference|0.5|||<|1|2-Sided|95.0|-16.0|18.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher’s exact test.|
1695057|NCT01050998|3117161|Superiority or Other||Percent difference|20.2|||<|0.032||95.0|2.8|36.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher’s exact test.|
1695058|NCT01050998|3117161|Superiority or Other||Percent difference|4.7|||<|0.589|2-Sided|95.0|-12.1|22.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|ACR20: p-value was calculated using a two-tailed Fisher’s exact test.|
1695059|NCT01050998|3117162|Superiority or Other||Ratio of expected duration of response|1.91|||<|0.001|2-Sided|95.0|1.34|2.72|||Exponential,Weibull and Log normal model||Ratio >1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.|
1695060|NCT01050998|3117162|Superiority or Other||Ratio of expected duration of response|1.26|||<|0.272|2-Sided|95.0|0.83|1.91|||Exponential,Weibull and Log normal model||Ratio >1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.|
1695061|NCT01050998|3117162|Superiority or Other||Ratio of expected duration of response|1.89|||<|0.001|2-Sided|95.0|1.31|2.71|||Exponential,Weibull and Log normal model||Ratio >1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.|
1695062|NCT01050998|3117162|Superiority or Other||Ratio of expected duration of response|0.97|||<|0.906|2-Sided|95.0|0.61|1.55|||Exponential,Weibull and Log normal model||Ratio >1 favored mavrilimumab.|Analysis reported for DAS28 (CRP) response.|
1695063|NCT01050998|3117162|Superiority or Other||Ratio of expected duration of response|2.09|||<|0.001|2-Sided|95.0|1.49|2.93|||Exponential,Weibull and Log normal model||Ratio >1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.|
1695064|NCT01050998|3117162|Superiority or Other||Ratio of expected duration of response|1.65|||<|0.006|2-Sided|95.0|1.15|2.36|||Exponential,Weibull and Log normal model||Ratio >1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.|
1695065|NCT01050998|3117162|Superiority or Other||Ratio of expected duration of response|1.54|||<|0.015|2-Sided|95.0|1.09|2.18|||Exponential,Weibull and Log normal model||Ratio >1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.|
1695066|NCT01050998|3117162|Superiority or Other||Ratio of expected duration of response|1.15|||<|0.486|2-Sided|95.0|0.78|1.69|||Exponential,Weibull and Log normal model||Ratio greater than (>) 1 favored mavrilimumab.|Analysis reported for DAS28 (ESR) response.|
1695067|NCT01050998|3117163|Superiority or Other||||||<|0.001|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.|
1695068|NCT01050998|3117163|Superiority or Other||||||<|0.125|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.|
1695069|NCT01050998|3117163|Superiority or Other||||||<|0.005|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.|
1695070|NCT01050998|3117163|Superiority or Other||||||<|0.831|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (ESR) response.|
1695071|NCT01050998|3117163|Superiority or Other||||||<|0.126|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.|
1695072|NCT01050998|3117163|Superiority or Other||||||<|0.001|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.|
1695073|NCT01050998|3117163|Superiority or Other||||||<|0.246|||||||Log Rank|||European region: Analysis reported for DAS28 (ESR) response.|
1695074|NCT01050998|3117163|Superiority or Other||||||<|0.004|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.|
1695075|NCT01050998|3117163|Superiority or Other||||||<|0.952|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.|
1695076|NCT01050998|3117163|Superiority or Other||||||<|0.013|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.|
1695077|NCT01050998|3117163|Superiority or Other||||||<|0.265|||||||Log Rank|||Japanese region: Analysis reported for DAS28 (CRP) response.|
1695078|NCT01050998|3117163|Superiority or Other||||||<|0.001|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.|
1695079|NCT01050998|3117163|Superiority or Other||||||<|0.134|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.|
1695080|NCT01050998|3117163|Superiority or Other||||||<|0.005|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.|
1695081|NCT01050998|3117163|Superiority or Other||||||<|0.237|||||||Log Rank|||European region: Analysis reported for DAS28 (CRP) response.|
1695082|NCT01050998|3117164|Superiority or Other|||||||0.047|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.|
1695083|NCT01050998|3117164|Superiority or Other||||||<|0.001|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.|
1695084|NCT01050998|3117164|Superiority or Other||||||<|0.282|||||||Log Rank|||Analysis reported for DAS28 (ESR) response.|
1695085|NCT01050998|3117164|Superiority or Other||||||<|0.145|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.|
1695086|NCT01050998|3117164|Superiority or Other||||||<|0.001|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.|
1695087|NCT01050998|3117164|Superiority or Other||||||<|0.604|||||||Log Rank|||Analysis reported for DAS28 (CRP) response.|
1695088|NCT01050998|3117165|Superiority or Other||Percent difference|-0.7||||1|2-Sided|95.0|-27.0|34.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 [ESR]): p-value was calculated using a two-tailed Fisher’s exact test.|
1695089|NCT01050998|3117165|Superiority or Other||Percent difference|-11.8||||1|2-Sided|95.0|-37.5|22.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 [ESR]): p-value was calculated using a two-tailed Fisher’s exact test.|
1695090|NCT01050998|3117165|Superiority or Other||Percent difference|-11.8||||0.529|2-Sided|95.0|-35.0|22.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 [ESR]): p-value was calculated using a two-tailed Fisher’s exact test.|
1695091|NCT01050998|3117165|Superiority or Other||Percent difference|13.2||||0.57|2-Sided|95.0|-16.6|51.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher’s exact test.|
1695092|NCT01050998|3117165|Superiority or Other||Percent difference|10.5||||0.591|2-Sided|95.0|-18.2|46.2|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher’s exact test.|
1695093|NCT01050998|3117165|Superiority or Other||Percent difference|38.2||||0.059|2-Sided|95.0|1.6|71.2|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher’s exact test.|
1695094|NCT01050998|3117165|Superiority or Other||Percent difference|-0.7||||1|2-Sided|95.0|-27.0|34.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|Japanese region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher’s exact test.|
1695095|NCT01050998|3117165|Superiority or Other||Percent difference|8.4||||0.052|2-Sided|95.0|0.6|21.6|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 [ESR]): p-value was calculated using a two-tailed Fisher’s exact test.|
1695096|NCT01050998|3117165|Superiority or Other||Percent difference|6.4||||0.115|2-Sided|95.0|-1.0|19.3|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 [ESR]): p-value was calculated using a two-tailed Fisher’s exact test.|
1695097|NCT01050998|3117165|Superiority or Other||Percent difference|16.4||||0.016|2-Sided|95.0|3.5|32.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher’s exact test.|
1695098|NCT01050998|3117165|Superiority or Other||Percent difference|11.3||||0.104|2-Sided|95.0|-0.6|26.9|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher’s exact test.|
1695099|NCT01050998|3117165|Superiority or Other||Percent difference|10.4||||0.11|2-Sided|95.0|-1.2|25.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher’s exact test.|
1695100|NCT01050998|3117165|Superiority or Other||Percent difference|8.7||||0.182|2-Sided|95.0|-2.7|24.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|European region (DAS28 [CRP]): p-value was calculated using a two-tailed Fisher’s exact test.|
1696401|NCT01033942|3118842|Superiority or Other|||||||0.6331|||||||Fisher Exact||||
1695101|NCT01050998|3117166|Superiority or Other||Percent difference|3.1||||0.406|2-Sided|95.0|-4.1|14.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher’s exact test.|
1695102|NCT01050998|3117166|Superiority or Other||Percent difference|5.1||||0.231|2-Sided|95.0|-2.8|16.8|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher’s exact test.|
1695103|NCT01050998|3117166|Superiority or Other||Percent difference|4.9||||0.237|2-Sided|95.0|-2.9|16.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher’s exact test.|
1695104|NCT01050998|3117166|Superiority or Other||Percent difference|3.0||||0.412|2-Sided|95.0|-4.2|14.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (ESR): p-value was calculated using a two-tailed Fisher’s exact test.|
1695105|NCT01050998|3117166|Superiority or Other||Percent difference|15.8||||0.015|2-Sided|95.0|2.9|31.0|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher’s exact test.|
1695106|NCT01050998|3117166|Superiority or Other||Percent difference|11.1||||0.09|2-Sided|95.0|0.0|25.4|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher’s exact test.|
1695107|NCT01050998|3117166|Superiority or Other||Percent difference|14.8||||0.017|2-Sided|95.0|2.8|29.7|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher’s exact test.|
1695108|NCT01050998|3117166|Superiority or Other||Percent difference|7.0||||0.238|2-Sided|95.0|-3.3|20.5|||Fisher Exact||95% unconditional exact CI was calculated using the method of Agresti and Min, 2001.|DAS28 (CRP): p-value was calculated using a two-tailed Fisher’s exact test.|
1695109|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-1.03|Standard Error of the Mean|0.465||0.031|2-Sided|95.0|-1.97|-0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.|
1695110|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-0.5|Standard Error of the Mean|0.448||0.271|2-Sided|95.0|-1.4|0.4|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.|
1695111|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-1.25|Standard Error of the Mean|0.468||0.011|2-Sided|95.0|-2.19|-0.31|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.|
1695112|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-0.08|Standard Error of the Mean|0.449||0.854|2-Sided|95.0|-0.99|0.82|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.|
1695113|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-0.86|Standard Error of the Mean|0.465||0.07|2-Sided|95.0|-1.8|0.07|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.|
1695114|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-0.04|Standard Error of the Mean|0.448||0.931|2-Sided|95.0|-0.94|0.86|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.|
1695115|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-1.19|Standard Error of the Mean|0.465||0.014|2-Sided|95.0|-2.13|-0.26|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.|
1695116|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|0.12|Standard Error of the Mean|0.447||0.785|2-Sided|95.0|-0.78|1.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Japanese region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.|
1695117|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-0.73|Standard Error of the Mean|0.238||0.002|2-Sided|95.0|-1.2|-0.26|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.|
1695118|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-0.41|Standard Error of the Mean|0.236||0.084|2-Sided|95.0|-0.88|0.06|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.|
1695136|NCT01050998|3117189|Superiority or Other||Percent difference|20.2||||0.049|2-Sided|95.0|0.7|38.2|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher’s exact test.|
1696402|NCT01033942|3118843|Superiority or Other|||||||0.0467|||||||Fisher Exact||||
1695119|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-0.64|Standard Error of the Mean|0.236||0.007|2-Sided|95.0|-1.11|-0.18|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.|
1695120|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-0.39|Standard Error of the Mean|0.241||0.107|2-Sided|95.0|-0.87|0.09|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (ESR) at Day 85.|
1695121|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-0.7|Standard Error of the Mean|0.227||0.002|2-Sided|95.0|-1.14|-0.25|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.|
1695122|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-0.43|Standard Error of the Mean|0.225||0.059|2-Sided|95.0|-0.87|0.02|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.|
1695123|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-0.55|Standard Error of the Mean|0.225||0.016|2-Sided|95.0|-0.99|-0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.|
1695124|NCT01050998|3117167|Superiority or Other||Adjusted mean difference|-0.4|Standard Error of the Mean|0.23||0.086|2-Sided|95.0|-0.85|0.06|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|European region: Analysis reported for change from baseline in DAS28 (CRP) at Day 85.|
1695125|NCT01050998|3117168|Superiority or Other||Adjusted mean difference|-0.8|Standard Error of the Mean|0.212|<|0.001|2-Sided|95.0|-1.22|-0.38|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.|
1695126|NCT01050998|3117168|Superiority or Other||Adjusted mean difference|-0.42|Standard Error of the Mean|0.209|<|0.046|2-Sided|95.0|-0.83|-0.01|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.|
1695127|NCT01050998|3117168|Superiority or Other||Adjusted mean difference|-0.76|Standard Error of the Mean|0.21|<|0.001|2-Sided|95.0|-1.17|-0.35|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.|
1695128|NCT01050998|3117168|Superiority or Other||Adjusted mean difference|-0.34|Standard Error of the Mean|0.212|<|0.107|2-Sided|95.0|-0.76|0.08|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (ESR) at Day 85.|
1695129|NCT01050998|3117168|Superiority or Other||Adjusted mean difference|-0.74|Standard Error of the Mean|0.204|<|0.001|2-Sided|95.0|-1.14|-0.33|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.|
1695130|NCT01050998|3117168|Superiority or Other||Adjusted mean difference|-0.35|Standard Error of the Mean|0.201|<|0.08|2-Sided|95.0|-0.75|0.04|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.|
1695131|NCT01050998|3117168|Superiority or Other||Adjusted mean difference|-0.67|Standard Error of the Mean|0.202|<|0.001|2-Sided|95.0|-1.07|-0.27|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.|
1695132|NCT01050998|3117168|Superiority or Other||Adjusted mean difference|-0.31|Standard Error of the Mean|0.205|<|0.137|2-Sided|95.0|-0.71|0.1|||Repeated measures model||An estimate of the treatment difference and its 95% CI was computed by means of repeated measures model, adjusted for baseline and including a treatment by visit interaction term. Differences <0 favored mavrilimumab.|Analysis reported for change from baseline in DAS28 (CRP) at Day 85.|
1695133|NCT01050998|3117189|Superiority or Other||Percent difference|57.4||||0.01|2-Sided|95.0|15.2|81.8|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher’s exact test.|
1695134|NCT01050998|3117189|Superiority or Other||Percent difference|26.8||||0.188|2-Sided|95.0|-9.3|60.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher’s exact test.|
1695135|NCT01050998|3117189|Superiority or Other||Percent difference|22.8||||0.03|2-Sided|95.0|3.2|40.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher’s exact test.|
1696403|NCT01033942|3118844|Superiority or Other|||||||0.2235|||||||Fisher Exact||||
1695137|NCT01050998|3117189|Superiority or Other||Percent difference|17.2||||0.084|2-Sided|95.0|-2.0|35.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher’s exact test.|
1695138|NCT01050998|3117189|Superiority or Other||Percent difference|9.9||||0.328|2-Sided|95.0|-9.3|29.4|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher’s exact test.|
1695139|NCT01050998|3117190|Superiority or Other||Percent difference|29.0||||0.002|2-Sided|95.0|11.3|45.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher’s exact test.|
1695140|NCT01050998|3117190|Superiority or Other||Percent difference|21.4||||0.02|2-Sided|95.0|3.9|37.8|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher’s exact test.|
1695141|NCT01050998|3117190|Superiority or Other||Percent difference|24.3||||0.008|2-Sided|95.0|7.0|40.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher’s exact test.|
1695142|NCT01050998|3117190|Superiority or Other||Percent difference|13.0||||0.152|2-Sided|95.0|-4.2|30.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher’s exact test.|
1695143|NCT01050998|3117191|Superiority or Other||Percent difference|9.8||||0.661|2-Sided|95.0|-24.3|46.9|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher’s exact test.|
1695144|NCT01050998|3117191|Superiority or Other||Percent difference|51.5||||0.028|2-Sided|95.0|8.2|77.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher’s exact test.|
1695145|NCT01050998|3117191|Superiority or Other||Percent difference|-1.3||||1|2-Sided|95.0|-33.7|35.7|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|Japanese region: p-value was calculated using a two-tailed Fisher’s exact test.|
1695146|NCT01050998|3117191|Superiority or Other||Percent difference|32.0||||0.001|2-Sided|95.0|12.5|49.0|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher’s exact test.|
1695147|NCT01050998|3117191|Superiority or Other||Percent difference|16.6||||0.108|2-Sided|95.0|-2.5|35.5|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher’s exact test.|
1695148|NCT01050998|3117191|Superiority or Other||Percent difference|26.3||||0.011|2-Sided|95.0|7.2|43.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher’s exact test.|
1695149|NCT01050998|3117191|Superiority or Other||Percent difference|6.4||||0.543|2-Sided|95.0|-11.9|25.4|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|European region: p-value was calculated using a two-tailed Fisher’s exact test.|
1695150|NCT01050998|3117192|Superiority or Other||Percent difference|35.5|||<|0.001|2-Sided|95.0|17.8|50.6|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher’s exact test.|
1695151|NCT01050998|3117192|Superiority or Other||Percent difference|15.3|||<|0.099|2-Sided|95.0|-1.6|32.2|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher’s exact test.|
1695152|NCT01050998|3117192|Superiority or Other||Percent difference|30.7|||<|0.001|2-Sided|95.0|13.4|46.3|||Fisher Exact||95% unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher’s exact test.|
1695153|NCT01050998|3117192|Superiority or Other||Percent difference|4.9|||<|0.578|2-Sided|95.0|-11.5|22.0|||Fisher Exact||95 percent (%) unconditional exact confidence interval calculated using the method of Agresti and Min, 2001.|p-value was calculated using a two-tailed Fisher’s exact test.|
1695154|NCT01050647|3117235|Superiority|||||||0.14|||||||Wilcoxon (Mann-Whitney)||||
1695155|NCT01050647|3117236|Superiority|||||||0.16|||||||Wilcoxon (Mann-Whitney)||||
1695156|NCT01050647|3117237|Superiority|||||||0.59|||||||Chi-squared||||
1695157|NCT01050647|3117238|Superiority||||||>|0.99|||||||Chi-squared||||
1695158|NCT01050647|3117239|Superiority|||||||0.31|||||||Chi-squared||||
1695159|NCT01050582|3117246|Superiority or Other||Odds Ratio (OR)|0.865|||>|0.999||95.0|0.189|3.963|||Fisher Exact||Estimated OR is from a logistic regression model including factors for treatment arm, age, indication, and use of concomitant medication with growth effects.|Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in frequency of retrospectively reported potentially prolactin-related adverse events|
1695160|NCT01050582|3117247|Superiority or Other||Slope|-0.221|Standard Error of the Mean|0.25||0.378|2-Sided|95.0|-0.711|0.269|||Regression, Linear|Covariates: Tanner stage and gender|Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipsychotics.|The null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in age (years) at current Tanner stage.|
1695161|NCT01050582|3117248|Superiority or Other||Slope|0.447|Standard Error of the Mean|0.116|<|0.001|2-Sided|95.0|0.22|0.674|||Regression, Linear|Covariates: weight (wt) divided expected wt for age and height (ht), age, use of concomitant medication with growth effects, preexposure ht z-score.|Slope associated with treatment dummy variable with 1 indicating risperidone and 0 indicating other atypical antipychotics.|Null hypothesis is that there is no difference between the risperidone and other atypical antipsychotics groups in current height z-score.|
1695186|NCT01049412|3117324|Superiority or Other||Least Squares Mean Difference (Final)|-0.47|Standard Error of the Mean|0.13|<|0.001|2-Sided|90.0|-0.69|-0.25||The statistical significance level is 0.10.|Mixed Models Analysis||||
1695162|NCT01050543|3117253|Superiority or Other||Mean Difference (Final Values)|8.1|||<|0.0001|2-Sided|95.0|6.8|9.6|||ANOVA|||To evaluate the efficacy of sugammadex compared to the efficacy of neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.9 was calculated using a 2-way ANOVA model adjusted for trial site.|
1695163|NCT01050530|3117254|Superiority or Other||Mean Difference (Final Values)|-300.7||||0.0093|2-Sided|95.0|-526.2|-75.1|||t-test, 2 sided||||
1695164|NCT01050530|3117255|Superiority or Other||Mean Difference (Final Values)|-1.51|||<|0.0001|2-Sided|95.0|-2.08|-0.93|||t-test, 2 sided||||
1695165|NCT01049984|3117295|Superiority or Other|||||||0.967||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment, pooled center, and baseline value as strata.|||
1695166|NCT01049984|3117296|Superiority or Other|||||||0.996||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment and pooled center as strata.|||
1695167|NCT01049984|3117297|Superiority or Other|||||||0.255||||||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted. Only participants with assessment (>0) are included in the CMH test.|Cochran-Mantel-Haenszel|CMH used the proportion of participants in each category between the two treatment arms, with treatment and pooled center as strata.|||
1695168|NCT01049984|3117298|Superiority or Other||Mean Difference (Final Values)|-1.8||||0.007|2-Sided|95.0|-3.1|-0.5||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.|||
1695169|NCT01049984|3117299|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.301|2-Sided|95.0|-1.1|0.3||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.|||
1695170|NCT01049984|3117300|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.012|2-Sided|95.0|-4.3|-0.5||All analyses were performed at the 2-sided 0.05 significance level. P values were not adjusted.|ANCOVA|Repeated measures model with baseline score as a covariate and factors Treatment, Week in Study, Pooled Center and Week by Treatment interaction.|||
1695171|NCT01049802|3117307|Superiority or Other|||||||0.05|||||||Mixed Models Analysis||||
1695172|NCT01049802|3117308|Superiority or Other|||||||0.05|||||||Mixed Models Analysis||||
1695173|NCT01049802|3117309|Superiority or Other|||||||0.05|||||||Mixed Models Analysis||||
1695174|NCT01049802|3117310|Superiority or Other|||||||0.05|||||||Mixed Models Analysis||||
1695175|NCT01049802|3117311|Superiority or Other|||||||0.05|||||||Mixed Models Analysis||||
1695176|NCT01049581|3117314|Superiority or Other|||||||0.332|||||||ANCOVA|||null hypothesis : there is no difference in social participation between pediatric aquatic therapy group and conventional therapy group|
1695177|NCT01049581|3117315|Non-Inferiority or Equivalence|ANCOVA : p value 0.393|Mean Difference (Net)|1.762||||0.393|1-Sided|95.0||||"Effect Size η2~0.023"|ANCOVA|F1,17= 0.380||We hypothesize that Children with CP receiving PAT would have better outcomes in motor function and translate to ADL|
1695178|NCT01049581|3117316|Non-Inferiority or Equivalence|ANCOVA was used and the result reveled (F1, 17 = 7.565, η2= 0.308, p = 0.007)||||||0.007|||||||ANCOVA|||null hypothesis : there is no difference in gross motor performance in pediatric aquatic therapy group and conventional therapy group|
1695179|NCT01049503|3117317|Superiority or Other||||||<|0.05|||||||Kruskal-Wallis|||GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.|
1695180|NCT01049503|3117318|Superiority or Other||||||<|0.05|||||||ANOVA|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from lesion area were evaluated by ANOVA after logarithmic transformation and Tukey’s test.|
1695181|NCT01049503|3117319|Superiority or Other||||||<|0.05|||||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from fluorescence loss were evaluated by Kruskal-Wallis and Dunn’s tests.|
1695182|NCT01049503|3117320|Superiority or Other||||||<|0.05|||||||ANOVA|||"The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by One-way ANOVA after logarithmic transformation and Tukey’s test."|
1695183|NCT01049503|3117321|Superiority or Other||||||<|0.05|||||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively.Data from the clinical exams were evaluated by Kruskal-Wallis' test.|
1695184|NCT01049503|3117322|Superiority or Other||||||<|0.05|||||||Kruskal-Wallis|||The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov; Smirnov and Bartlett tests, respectively. Data from the clinical exams were evaluated by Kruskal-Wallis' test.|
1695185|NCT01049503|3117323|Superiority or Other||||||<|0.05|||||||ANOVA|||"The softwares GraphPad InStat version 3.0 for Windows and GraphPad Prism version 4.0 for Windows (GraphPad Software, La Jolla, Ca, USA) were used. Data were checked for normality and homogeneity using Kolmogorov and Smirnov and Bartlett tests, respectively.~Data were analyzed by 2-way RM-ANOVA after logarithmic transformation and Bonferroni’s test."|
1695187|NCT01049412|3117325|Superiority or Other|||||||0.037||||||The statistical significance level is 0.10.|Negative Binomial Model||||
1695188|NCT01049412|3117330|Superiority or Other||Least Squares Mean Difference (Final)|-1.1|Standard Error of the Mean|0.33||0.001|2-Sided|90.0|-1.64|-0.55||"The statistical significance level is 0.10.~P-value is for bed time BG."|Mixed Models Analysis||||
1695189|NCT01049412|3117330|Superiority or Other||Least Squares Mean Difference (Final)|-0.89|Standard Error of the Mean|0.29||0.003|2-Sided|90.0|-1.38|-0.41||"The statistical significance level is 0.10.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||||
1695190|NCT01049412|3117330|Superiority or Other||Least Squares Mean Difference (Final)|-0.86|Standard Error of the Mean|0.32||0.008|2-Sided|90.0|-1.39|-0.34||"The statistical significance level is 0.10.~P-value is for evening pre-meal BG."|Mixed Models Analysis||||
1695191|NCT01049412|3117330|Superiority or Other||Least Squares Mean Difference (Final)|-0.52|Standard Error of the Mean|0.28||0.07|2-Sided|90.0|-0.99|-0.05||"The statistical significance level is 0.10.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||||
1695192|NCT01049412|3117330|Superiority or Other||Least Squares Mean Difference (Final)|-0.54|Standard Error of the Mean|0.3||0.079|2-Sided|90.0|-1.05|-0.03||"The statistical significance level is 0.10.~P-value is for midday pre-meal BG."|Mixed Models Analysis||||
1695193|NCT01049412|3117330|Superiority or Other||Least Squares Mean Difference (Final)|-0.48|Standard Error of the Mean|0.33||0.151|2-Sided|90.0|-1.04|0.07||"The statistical significance level is 0.10.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis||||
1695194|NCT01049412|3117330|Superiority or Other||Least Squares Mean Difference (Final)|-0.24|Standard Error of the Mean|0.33||0.464|2-Sided|90.0|-0.79|0.3||"The statistical significance level is 0.10.~P-value is for morning FBG."|Mixed Models Analysis||||
1695195|NCT01049412|3117330|Superiority or Other||Least Squares Mean Difference (Final)|0.3|Standard Error of the Mean|0.35||0.392|2-Sided|90.0|-0.28|0.88||"The statistical significance level is 0.10.~P-value is for 0300 hour BG."|Mixed Models Analysis||||
1695196|NCT01049412|3117332|Superiority or Other|||||||0.119||||||"The statistical significance level is 0.10.~P-value is for HbA1c ≤6.5%."|Fisher Exact||||
1695197|NCT01049412|3117332|Superiority or Other|||||||0.276||||||"The statistical significance level is 0.10.~P-value is for HbA1c <7.0%."|Fisher Exact||||
1695198|NCT01049412|3117333|Superiority or Other||Least Squares Mean Difference (Final)|-0.11|Standard Error of the Mean|0.1||0.242|2-Sided|90.0|-0.28|0.05||The statistical significance level is 0.10.|Mixed Models Analysis||||
1695199|NCT01049412|3117334|Superiority or Other||Least Squares Mean Difference (Final)|-0.56|Standard Error of the Mean|0.16|<|0.001|2-Sided|90.0|-0.83|-0.29||The statistical significance level is 0.10.|Mixed Models Analysis||||
1695200|NCT01049412|3117335|Superiority or Other||Least Squares Mean Difference (Final)|-0.55|Standard Error of the Mean|0.16|<|0.001|2-Sided|90.0|-0.81|-0.29||The statistical significance level is 0.10.|Mixed Models Analysis||||
1695201|NCT01049373|3117348|Superiority or Other|||||||0.04443|||||||Wilcoxon (Mann-Whitney)||||
1695202|NCT01049373|3117349|Superiority or Other|||||||0.0465|||||||Wilcoxon (Mann-Whitney)||||
1695203|NCT01049373|3117350|Superiority or Other|||||||0.0757|||||||Wilcoxon (Mann-Whitney)||||
1695204|NCT01049373|3117351|Superiority or Other|||||||0.0426|||||||Wilcoxon (Mann-Whitney)||||
1695205|NCT01049360|3117352|Superiority or Other||Least squares mean difference|0.275|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.224|0.325|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate|||
1695206|NCT01049360|3117352|Superiority or Other||Least squares mean difference|0.281|Standard Error of the Mean|0.026|<|0.0001|2-Sided|95.0|0.23|0.333|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate|||
1695207|NCT01049360|3117353|Superiority or Other||Least squares mean difference|0.137|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.088|0.185|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate|||
1695208|NCT01049360|3117353|Superiority or Other||Least square mean difference|0.132|Standard Error of the Mean|0.025|<|0.0001|2-Sided|95.0|0.083|0.181|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate|||
1695209|NCT01049360|3117354|Superiority or Other||Least square mean difference|0.202|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.158|0.245|||Mixed Models Analysis|Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate|||
1695210|NCT01049360|3117354|Superiority or Other||Least square mean difference|0.2|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.156|0.245||Treatment and period were fixed effects, subjects was random effect, and baseline values at each period were a covariate|Mixed Models Analysis||||
1695211|NCT01049334|3117355|Superiority or Other|||||||0.0098|||||||Wilcoxon (Mann-Whitney)||||
1695212|NCT01049334|3117356|Superiority or Other|||||||0.0273|||||||Log Rank||||
1695213|NCT01049334|3117357|Superiority or Other||least-square means difference|-3.0||||0.0476|2-Sided|95.0|-6.0|0.0|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 40|
1695214|NCT01049334|3117357|Superiority or Other||least-square means difference|-2.7||||0.062|2-Sided|95.0|-5.5|0.1|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 38|
1695215|NCT01049334|3117357|Superiority or Other||least-square means difference|-2.4||||0.0788|2-Sided|95.0|-5.0|0.3|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 36|
1695216|NCT01049334|3117357|Superiority or Other||least-square means difference|-2.0||||0.103|2-Sided|95.0|-4.5|0.4|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 34|
1695217|NCT01049334|3117357|Superiority or Other||least-square means difference|-1.8||||0.134|2-Sided|95.0|-4.1|0.5|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 32|
1695218|NCT01049334|3117357|Superiority or Other||least-square means difference|-1.5||||0.1715|2-Sided|95.0|-3.6|0.6|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 30|
1695219|NCT01049334|3117357|Superiority or Other||least-square means difference|-1.2||||0.2137|2-Sided|95.0|-3.2|0.7|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 28|
1695220|NCT01049334|3117357|Superiority or Other||least-square means difference|-1.0||||0.2679|2-Sided|95.0|-2.8|0.8|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 26|
1695455|NCT01045161|3117752|Superiority or Other||Least squares mean difference|0.072||||0.0012|2-Sided|95.0|0.03|0.12|||ANCOVA||||
1695221|NCT01049334|3117357|Superiority or Other||least-square means difference|-0.8||||0.3501|2-Sided|95.0|-2.4|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 24|
1695222|NCT01049334|3117357|Superiority or Other||least-square means difference|-0.6||||0.4313|2-Sided|95.0|-2.1|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 22|
1695223|NCT01049334|3117357|Superiority or Other||least-square means difference|-0.4||||0.5414|2-Sided|95.0|-1.8|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 20|
1695224|NCT01049334|3117357|Superiority or Other||least-square means difference|-0.3||||0.6732|2-Sided|95.0|-1.4|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 18|
1695225|NCT01049334|3117357|Superiority or Other||least-square means difference|-0.1||||0.8493|2-Sided|95.0|-1.1|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 16|
1695226|NCT01049334|3117357|Superiority or Other||least-square means difference|0.0||||0.937|2-Sided|95.0|-0.8|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 14|
1695227|NCT01049334|3117357|Superiority or Other||least-square means difference|0.1||||0.6975|2-Sided|95.0|-0.6|0.9|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 12|
1695228|NCT01049334|3117357|Superiority or Other||least-square means difference|0.2||||0.4758|2-Sided|95.0|-0.4|0.8|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 10|
1695229|NCT01049334|3117357|Superiority or Other||least-square means difference|0.2||||0.2906|2-Sided|95.0|-0.2|0.7|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 8|
1695230|NCT01049334|3117357|Superiority or Other||least-square means difference|0.2||||0.1407|2-Sided|95.0|-0.1|0.5|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 6|
1695231|NCT01049334|3117357|Superiority or Other||least-square means difference|0.1||||0.1538|2-Sided|95.0|0.0|0.3|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 4|
1695232|NCT01049334|3117357|Superiority or Other||least-square means difference|0.1||||0.1448|2-Sided|95.0|0.0|0.1|||ANOVA|Baseline STPIS fitted as a covariate||Minutes post dose: 2|
1695233|NCT01049334|3117358|Superiority or Other||||||<|0.0001||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.|Wilcoxon (Mann-Whitney)||||
1695234|NCT01049334|3117359|Superiority or Other||least-square means difference|-156.3||||0.0435|2-Sided|95.0|-307.9|-4.6||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.|ANOVA||||
1695235|NCT01049334|3117360|Superiority or Other|||||||0.0002||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.|Wilcoxon (Mann-Whitney)||||
1695236|NCT01049334|3117361|Superiority or Other|||||||0.0005||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.|Wilcoxon (Mann-Whitney)||||
1695237|NCT01049334|3117362|Superiority or Other|||||||0.0005||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.|Wilcoxon (Mann-Whitney)||||
1695238|NCT01049334|3117363|Superiority or Other|||||||0.8383||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.|Wilcoxon (Mann-Whitney)||||
1695239|NCT01049334|3117364|Superiority or Other|||||||0.0459||||||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.|Wilcoxon (Mann-Whitney)||||
1695240|NCT01049334|3117365|Superiority or Other||least-square means difference|-137.6||||0.0393|2-Sided|95.0|-268.5|-6.8||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate|||
1695241|NCT01049334|3117366|Superiority or Other||least-square means difference|-20.8|||<|0.0001|2-Sided|95.0|-30.2|-11.2||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate|||
1695242|NCT01049334|3117367|Superiority or Other||least-square means difference|-181.7||||0.0071|2-Sided|95.0|-313.7|-50.0||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate|||
1695243|NCT01049334|3117368|Superiority or Other||least-square means difference|-22.3|||<|0.0001|2-Sided|95.0|-31.7|-12.9||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate|||
1695244|NCT01049334|3117369|Superiority or Other||least-square means difference|-19.6|||<|0.0001|2-Sided|95.0|-29.2|-9.9||The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.|ANOVA|Treatment as a fixed effect and baseline of the variable predicted as a covariate|||
1695245|NCT01049334|3117370|Superiority or Other||least-square means difference|-151.5||||0.0201|2-Sided|95.0|-278.9|-24.0||The a priori threshold for statistical significance is 0.05. No adjustments for statistical multiplicity were required.|ANOVA|Treatment as a fixed effect and baseline STPIS as a covariate.|||
1695246|NCT01049308|3117372|Superiority or Other||percentage|57.6|||||2-Sided|||||||||Descriptive data to describe prevalence of cognitive impairment in outpatient veterans with chronic heart failure|
1695247|NCT01049217|3117390|Superiority or Other||LS Mean Difference|0.08|Standard Error of the Mean|0.967||0.9361|2-Sided|95.0|-1.82|1.98|||ANCOVA|||Change at Endpoint, Mn C: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695248|NCT01049217|3117390|Superiority or Other||LS Mean Difference|-0.41|Standard Error of the Mean|1.811||0.8199|2-Sided|95.0|-3.98|3.15|||ANCOVA|||Change at Endpoint, MnH: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695249|NCT01049217|3117390|Superiority or Other||LS Mean Difference|2.79|Standard Error of the Mean|2.543||0.2736|2-Sided|95.0|-2.21|7.79|||ANCOVA|||Change at Endpoint, R-E: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695250|NCT01049217|3117390|Superiority or Other||LS Mean Difference|-1.97|Standard Error of the Mean|2.159||0.3625|2-Sided|95.0|-6.22|2.28|||ANCOVA|||Change at Endpoint, So Fn: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695251|NCT01049217|3117390|Superiority or Other||LS Mean Difference|-1.33|Standard Error of the Mean|1.847||0.4734|2-Sided|95.0|-4.96|2.31|||ANCOVA|||Change at Endpoint, Vit: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695252|NCT01049217|3117390|Superiority or Other||LS Mean Difference|0.15|Standard Error of the Mean|0.807||0.8569|2-Sided|95.0|-1.44|1.73|||ANCOVA|||Change at Endpoint, Ph C: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695253|NCT01049217|3117390|Superiority or Other||LS Mean Difference|0.76|Standard Error of the Mean|1.937||0.6966|2-Sided|95.0|-3.05|4.57|||ANCOVA|||Change at Endpoint, GH: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695254|NCT01049217|3117390|Superiority or Other||LS Mean Difference|0.08|Standard Error of the Mean|2.335||0.9737|2-Sided|95.0|-4.52|4.67|||ANCOVA|||Change at Endpoint, BP: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695255|NCT01049217|3117390|Superiority or Other||LS Mean Difference|0.57|Standard Error of the Mean|2.522||0.8209|2-Sided|95.0|-4.39|5.53|||ANCOVA|||Change at Endpoint, R-P: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695256|NCT01049217|3117390|Superiority or Other||LS Mean Difference|1.22|Standard Error of the Mean|2.393||0.6114|2-Sided|95.0|-3.49|5.92|||ANCOVA|||Change at Endpoint, Ph Fn: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695257|NCT01049217|3117391|Superiority or Other||LS Mean Difference|0.65|Standard Error of the Mean|0.372||0.084|2-Sided|95.0|-0.09|1.38|||ANCOVA|||Change at Endpoint, HADS-D: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695258|NCT01049217|3117391|Superiority or Other||LS Mean Difference|0.08|Standard Error of the Mean|0.386||0.8258|2-Sided|95.0|-0.67|0.84|||ANCOVA|||Change at Endpoint, HADS-A: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695259|NCT01049217|3117392|Superiority or Other|||||||0.7399|||||||Cochran-Mantel-Haenszel|||Endpoint: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.|
1695260|NCT01049217|3117393|Superiority or Other||LS Mean Difference|0.18|Standard Error of the Mean|1.614||0.9113|2-Sided|95.0|-3.0|3.36|||ANCOVA|||Change at Endpoint, Sleep Problems Index: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695261|NCT01049217|3117393|Superiority or Other||LS Mean Difference|1.16|Standard Error of the Mean|1.933||0.5492|2-Sided|95.0|-2.64|4.96|||ANCOVA|||Change at Endpoint, Somnolence: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695262|NCT01049217|3117393|Superiority or Other||LS Mean Difference|3.02|Standard Error of the Mean|2.611||0.2475|2-Sided|95.0|-2.11|8.16|||ANCOVA|||Change at Endpoint, Adequacy: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695263|NCT01049217|3117393|Superiority or Other||LS Mean Difference|-0.18|Standard Error of the Mean|0.165||0.2783|2-Sided|95.0|-0.5|0.15|||ANCOVA|||Change at Endpoint, Quantity: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695264|NCT01049217|3117393|Superiority or Other||LS Mean Difference|0.89|Standard Error of the Mean|2.525||0.7237|2-Sided|95.0|-4.07|5.86|||ANCOVA|||Change at Endpoint, SOB: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695265|NCT01049217|3117393|Superiority or Other||LS Mean Difference|2.88|Standard Error of the Mean|3.179||0.365|2-Sided|95.0|-3.37|9.14|||ANCOVA|||Change at Endpoint, Snoring: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695266|NCT01049217|3117393|Superiority or Other||LS Mean Difference|-0.38|Standard Error of the Mean|2.052||0.8528|2-Sided|95.0|-4.42|3.66|||ANCOVA|||Change at Endpoint, Sleep Disturbance: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695267|NCT01049217|3117394|Non-Inferiority or Equivalence|ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.|LS Mean Difference|0.15|Standard Error of the Mean|0.66||0.8241|2-Sided||||||ANCOVA||||
1695268|NCT01049217|3117395|Superiority or Other||LS Mean Difference|-8436.0|Standard Error of the Mean|6855.2||0.2195|2-Sided||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.|
1695269|NCT01049217|3117396|Superiority or Other||LS Mean Difference|0.97|Standard Error of the Mean|0.51||0.0611|2-Sided||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.|
1695270|NCT01049217|3117397|Superiority or Other||LS Mean Difference|-1.03|Standard Error of the Mean|0.62||0.0966|2-Sided||||||ANCOVA|||ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.|
1695271|NCT01049217|3117398|Superiority or Other||LS Mean Difference|-3.66|Standard Error of the Mean|1.89||0.0534|2-Sided||||||ANCOVA|||Endpoint MIS: ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.|
1695272|NCT01049217|3117398|Superiority or Other||LS Mean Difference|-3.44|Standard Error of the Mean|6.58||0.6012|2-Sided||||||ANCOVA|||Endpoint TST: ANCOVA model was used with treatment as a fixed effect and D-drug ART, pooled site value, baseline value as covariates.|
1695456|NCT01045161|3117752|Superiority or Other||Least Squares Mean Difference|0.051||||0.019|2-Sided|95.0|0.01|0.09|||ANCOVA||||
1695273|NCT01049217|3117399|Superiority or Other||LS Mean Difference|-0.01|Standard Error of the Mean|0.02||0.7801|2-Sided|95.0|-0.04|0.03|||ANCOVA|||Change at Endpoint, Total Score: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695274|NCT01049217|3117399|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.024||0.9394|2-Sided|95.0|-0.05|0.04|||ANCOVA|||Change at Endpoint, P/D: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695275|NCT01049217|3117399|Superiority or Other||LS Mean Difference|-0.01|Standard Error of the Mean|0.021||0.6042|2-Sided|95.0|-0.05|0.03|||ANCOVA|||Change at Endpoint, Evoked Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695276|NCT01049217|3117399|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.023||0.9215|2-Sided|95.0|-0.04|0.05|||ANCOVA|||Change at Endpoint, Paroxysmal Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695277|NCT01049217|3117399|Superiority or Other||LS Mean Difference|-0.02|Standard Error of the Mean|0.022||0.4711|2-Sided|95.0|-0.06|0.03|||ANCOVA|||Change at Endpoint, Pressing Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695278|NCT01049217|3117399|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.025||0.9686|2-Sided|95.0|-0.05|0.05|||ANCOVA|||Change at Endpoint, Burning Pain: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695279|NCT01049217|3117400|Superiority or Other|||||||0.0559|||||||Cochran-Mantel-Haenszel|||Number of Pain Attacks: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.|
1695280|NCT01049217|3117400|Superiority or Other|||||||0.73|||||||Cochran-Mantel-Haenszel|||Duration of Spontaneous Pain: Overall p-value was derived from CMH test adjusted for pooled site and D-drug ART use using modified ridit scores.|
1695281|NCT01049217|3117401|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.25||0.9091|2-Sided|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Tingling: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695282|NCT01049217|3117401|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.26||0.9676|2-Sided|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Pins and Needles: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695283|NCT01049217|3117401|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.25||0.8996|2-Sided|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Cold of Area: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695284|NCT01049217|3117401|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.25||0.3164|2-Sided|95.0|-0.7|0.2|||ANCOVA|||Change at Endpoint, Pressure of Area: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695285|NCT01049217|3117401|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.24||0.8241|2-Sided|95.0|-0.5|0.4|||ANCOVA|||Change at Endpoint, Light Touching: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695286|NCT01049217|3117401|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.25||0.8718|2-Sided|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Stabbing: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695287|NCT01049217|3117401|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.25||0.9937|2-Sided|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Electric Shocks: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695288|NCT01049217|3117401|Superiority or Other||LS Mean Difference|-0.1|Standard Error of the Mean|0.24||0.563|2-Sided|95.0|-0.6|0.3|||ANCOVA|||Change at Endpoint, Pressure: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695289|NCT01049217|3117401|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.23||0.4476|2-Sided|95.0|-0.6|0.3|||ANCOVA|||Change at Endpoint, Squeezing: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695290|NCT01049217|3117401|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.25||0.9686|2-Sided|95.0|-0.5|0.5|||ANCOVA|||Change at Endpoint, Burning: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695291|NCT01049217|3117402|Superiority or Other||LS Mean Difference|0.19|Standard Error of the Mean|0.199||0.3511|2-Sided|95.0|-0.21|0.58|||ANCOVA|||Change at Endpoint, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695292|NCT01049217|3117402|Superiority or Other||LS Mean Difference|0.18|Standard Error of the Mean|0.204||0.3682|2-Sided|95.0|-0.22|0.58|||ANCOVA|||Change at Week 16, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695293|NCT01049217|3117402|Superiority or Other||LS Mean Difference|0.05|Standard Error of the Mean|0.218||0.8163|2-Sided|95.0|-0.38|0.48|||ANCOVA|||Change at Week 12, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695294|NCT01049217|3117402|Superiority or Other||LS Mean Difference|0.01|Standard Error of the Mean|0.213||0.9715|2-Sided|95.0|-0.41|0.43|||ANCOVA|||Change at Week 8, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695295|NCT01049217|3117402|Superiority or Other||LS Mean Difference|-0.07|Standard Error of the Mean|0.204||0.7412|2-Sided|95.0|-0.47|0.33|||ANCOVA|||Change at Week 4, PII: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695296|NCT01049217|3117402|Superiority or Other||LS Mean Difference|0.01|Standard Error of the Mean|0.203||0.9475|2-Sided|95.0|-0.39|0.41|||ANCOVA|||Change at Endpoint, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695297|NCT01049217|3117402|Superiority or Other||LS Mean Difference|0.08|Standard Error of the Mean|0.209||0.6913|2-Sided|95.0|-0.33|0.5|||ANCOVA|||Change at Week 16, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695298|NCT01049217|3117402|Superiority or Other||LS Mean Difference|0.05|Standard Error of the Mean|0.226||0.8179|2-Sided|95.0|-0.39|0.5|||ANCOVA|||Change at Week 12, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1696404|NCT01033942|3118845|Superiority or Other|||||||0.3884|||||||Fisher Exact||||
1695299|NCT01049217|3117402|Superiority or Other||LS Mean Difference|-0.17|Standard Error of the Mean|0.203||0.4167|2-Sided|95.0|-0.57|0.23|||ANCOVA|||Change at Week 8, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695300|NCT01049217|3117402|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.177||0.0948|2-Sided|95.0|-0.64|0.05|||ANCOVA|||Change at Week 4, PSI: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695301|NCT01049217|3117403|Superiority or Other||LS Mean Difference|0.02|Standard Error of the Mean|0.19||0.9009|2-Sided|95.0|-0.35|0.4|||ANCOVA|||Change at Endpoint: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695302|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.06|Standard Error of the Mean|0.245||0.8067|2-Sided|95.0|-0.54|0.42|||ANCOVA|||Change at Week 16: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695303|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.03|Standard Error of the Mean|0.228||0.8927|2-Sided|95.0|-0.48|0.42|||ANCOVA|||Change at Week 15: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695304|NCT01049217|3117403|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.228||0.9991|2-Sided|95.0|-0.45|0.45|||ANCOVA|||Change at Week 14: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695305|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.03|Standard Error of the Mean|0.219||0.8905|2-Sided|95.0|-0.46|0.4|||ANCOVA|||Change at Week 13: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695306|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.13|Standard Error of the Mean|0.227||0.5752|2-Sided|95.0|-0.57|0.32|||ANCOVA|||Change at Week 12: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695307|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.11|Standard Error of the Mean|0.222||0.63|2-Sided|95.0|-0.54|0.33|||ANCOVA|||Change at Week 11: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695308|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.21|Standard Error of the Mean|0.212||0.3143|2-Sided|95.0|-0.63|0.2|||ANCOVA|||Change at Week 10: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695309|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.21|Standard Error of the Mean|0.208||0.3231|2-Sided|95.0|-0.62|0.2|||ANCOVA|||Change at Week 9: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695310|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.11|Standard Error of the Mean|0.203||0.5757|2-Sided|95.0|-0.51|0.29|||ANCOVA|||Change at Week 8: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695311|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.14|Standard Error of the Mean|0.197||0.483|2-Sided|95.0|-0.53|0.25|||ANCOVA|||Change at Week 7: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695312|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.24|Standard Error of the Mean|0.189||0.2104|2-Sided|95.0|-0.61|0.13|||ANCOVA|||Change at Week 6: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695313|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.32|Standard Error of the Mean|0.173||0.0667|2-Sided|95.0|-0.66|0.02|||ANCOVA|||Change at Week 5: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695314|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.26|Standard Error of the Mean|0.164||0.1141|2-Sided|95.0|-0.58|0.06|||ANCOVA|||Change at Week 4: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695315|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.27|Standard Error of the Mean|0.137||0.0504|2-Sided|95.0|-0.54|0.0|||ANCOVA|||Change at Week 3: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695316|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.14|Standard Error of the Mean|0.118||0.2429|2-Sided|95.0|-0.37|0.09|||ANCOVA|||Change at Week 2: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695317|NCT01049217|3117403|Superiority or Other||LS Mean Difference|-0.09|Standard Error of the Mean|0.085||0.3098|2-Sided|95.0|-0.25|0.08|||ANCOVA|||Change at Week 1: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695318|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.04|Standard Error of the Mean|0.199||0.8402|2-Sided|95.0|-0.43|0.35|||ANCOVA|||Change at Endpoint: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695319|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.259||0.4334|2-Sided|95.0|-0.71|0.31|||ANCOVA|||Change at Week 16: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695320|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.09|Standard Error of the Mean|0.243||0.7205|2-Sided|95.0|-0.57|0.39|||ANCOVA|||Change at Week 15: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695321|NCT01049217|3117404|Superiority or Other||LS Mean Difference|0.03|Standard Error of the Mean|0.24||0.9064|2-Sided|95.0|-0.45|0.5|||ANCOVA|||Change at Week 14: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695322|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.03|Standard Error of the Mean|0.24||0.9008|2-Sided|95.0|-0.5|0.44|||ANCOVA|||Change at Week 13: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695323|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.07|Standard Error of the Mean|0.24||0.7843|2-Sided|95.0|-0.54|0.41|||ANCOVA|||Change at Week 12: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695324|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.14|Standard Error of the Mean|0.229||0.5469|2-Sided|95.0|-0.59|0.31|||ANCOVA|||Change at Week 11: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695325|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.13|Standard Error of the Mean|0.219||0.5452|2-Sided|95.0|-0.56|0.3|||ANCOVA|||Change at Week 10: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695326|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.25|Standard Error of the Mean|0.223||0.2669|2-Sided|95.0|-0.69|0.19|||ANCOVA|||Change at Week 9: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695327|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.15|Standard Error of the Mean|0.219||0.4879|2-Sided|95.0|-0.58|0.28|||ANCOVA|||Change at Week 8: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695328|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.21|Standard Error of the Mean|0.214||0.3246|2-Sided|95.0|-0.63|0.21|||ANCOVA|||Change at Week 7: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695329|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.28|Standard Error of the Mean|0.199||0.166|2-Sided|95.0|-0.67|0.12|||ANCOVA|||Change at Week 6: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695330|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.39|Standard Error of the Mean|0.184||0.0373|2-Sided|95.0|-0.75|-0.02|||ANCOVA|||Change at Week 5: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695331|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.27|Standard Error of the Mean|0.177||0.1224|2-Sided|95.0|-0.62|0.07|||ANCOVA|||Change at Week 4: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695332|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.28|Standard Error of the Mean|0.142||0.0468|2-Sided|95.0|-0.56|0.0|||ANCOVA|||Change at Week 3: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695333|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.18|Standard Error of the Mean|0.126||0.1516|2-Sided|95.0|-0.43|0.07|||ANCOVA|||Change at Week 2: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695334|NCT01049217|3117404|Superiority or Other||LS Mean Difference|-0.12|Standard Error of the Mean|0.095||0.2084|2-Sided|95.0|-0.31|0.07|||ANCOVA|||Change at Week 1: ANCOVA model was used with terms of treatment, pooled site, D-drug ART use and baseline score.|
1695335|NCT01049217|3117405|Superiority or Other|||||||0.4271|||||||Cochran-Mantel-Haenszel|||Overall p-value was derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled site and D-drug ART use using modified ridit scores.|
1695336|NCT01049217|3117406|Superiority or Other|||||||0.5049|||||||Cochran-Mantel-Haenszel|||Overall p-value was derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled site and D-drug ART use using modified ridit scores.|
1695337|NCT01049217|3117407|Superiority or Other||Least Squares (LS) Mean Difference|0.07|Standard Error of the Mean|0.191||0.709|2-Sided|95.0|-0.3|0.45|||ANCOVA|||Analysis of covariance (ANCOVA) model was used with terms of treatment, pooled site, dideoxynucleoside analogue (D-drug) anti-retroviral agent (ART) use and baseline score.|
1695338|NCT01048944|3117411|Superiority or Other||||||<|0.05||||||P values are adjusted for multiple comparisons except for specific a priori directional predictions.|Mixed Models Analysis|||Mixed-model repeated measures multivariate analyses of variance assessed Treatment x Day of abstinence (days 3, 24, 45, and 66) based on changes from pre-quit baseline to values of the four post-quit time points (days 3, 24, 45, and 66).|
1695339|NCT01048866|3117414|Superiority or Other||least-square means difference|-0.1||||0.4274|2-Sided|95.0|-0.3|0.1|||ANOVA||||
1695340|NCT01048866|3117415|Superiority or Other||least-square means difference|-0.2||||0.0288|2-Sided|95.0|-0.4|0.0|||ANOVA||||
1695341|NCT01048866|3117416|Superiority or Other|||||||0.0276|||||||Log Rank||||
1695342|NCT01048866|3117417|Superiority or Other|||||||0.0322|||||||Regression, Logistic|Effect for centre|||
1695343|NCT01048866|3117418|Superiority or Other||least-square means difference|0.5||||0.0195|2-Sided|95.0|0.1|0.9|||ANOVA|Repeated measures ANOVA model with participant as a random effect.|||
1695344|NCT01048866|3117419|Superiority or Other||least-square means difference|-6.0||||0.0595|2-Sided|95.0|-12.3|0.2|||ANOVA|Repeated measures ANOVA model with participant as a random effect.|||
1695345|NCT01048866|3117420|Superiority or Other||least-square means difference|-5.5||||0.0871|2-Sided|95.0|-11.7|0.8|||ANOVA|Repeated measures ANOVA model with patient as a random effect.|||
1695346|NCT01048866|3117421|Superiority or Other||least-square means difference|-5.9||||0.0743|2-Sided|95.0|-12.4|0.6|||ANOVA|Repeated measures ANOVA model with participant as a random effect.|||
1695347|NCT01048866|3117423|Superiority or Other|||||||0.0105|||||||Wilcoxon (Mann-Whitney)|Stratified by centre|||
1695348|NCT01048866|3117424|Superiority or Other|||||||0.8827|||||||Wilcoxon (Mann-Whitney)||||
1695349|NCT01048866|3117425|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1695350|NCT01048866|3117426|Superiority or Other||least-square means difference|-118.9||||0.1844|2-Sided|95.0|-295.3|57.5|||ANOVA|Baseline STPIS fitted as a covariate and centre as a fixed effect.|||
1695351|NCT01048866|3117427|Superiority or Other||least-square means difference|-19.0|||<|0.0001|2-Sided|95.0|-28.0|-10.0|||ANOVA|Baseline STPIS fitted as a covariate and centre as a fixed effect.|||
1695352|NCT01048866|3117428|Superiority or Other||least-square means difference|-168.4||||0.0087|2-Sided|95.0|-293.7|-43.1|||ANOVA||||
1695353|NCT01048866|3117429|Superiority or Other||least-square means difference|-16.4||||0.0008|2-Sided|95.0|-25.9|-7.0||The a priori threshold for statistical significance is 0.05.|ANOVA||||
1695354|NCT01048866|3117430|Superiority or Other||least-square means difference|-179.7||||0.0054|2-Sided|95.0|-305.7|-53.8||The a priori threshold for statistical significance is 0.05.|ANOVA||||
1695355|NCT01048866|3117431|Superiority or Other||least-square means difference|-19.0||||0.0002|2-Sided|95.0|-28.7|-9.3||The a priori threshold for statistical significance is 0.05.|ANOVA|Baseline DSS fitted as a covariate and centre as a fixed effect.|||
1695356|NCT01048866|3117432|Superiority or Other||least-square means difference|-196.6||||0.0021|2-Sided|95.0|-321.0|-72.2||The a priori threshold for statistical significance is 0.05.|ANOVA||||
1695357|NCT01048333|3117497|Superiority or Other||Hazard Ratio (HR)|3.127||||0.001|2-Sided|95.0|1.77|5.52|||Regression, Cox||||
1695358|NCT01048333|3117497|Superiority or Other||Hazard Ratio (HR)|6.534||||0.001|2-Sided|95.0|3.55|12.02|||Regression, Cox||||
1695359|NCT01048333|3117497|Superiority or Other||Hazard Ratio (HR)|2.09||||0.002|2-Sided|95.0|1.31|3.35|||Regression, Cox||||
1695360|NCT01047709|3117516|Superiority or Other||Relative % difference|19.5|Standard Deviation|16.0||0.011||95.0|4.9|31.9|||GEE||SD of intervention night|Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.|
1695361|NCT01047709|3117516|Superiority or Other||relative % difference|19.5|Standard Deviation|23.0||0.011|2-Sided|95.0|4.9|31.9|||GEE||SD of control night|Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.|
1695362|NCT01047436|3117560|Superiority or Other||Hazard Ratio (HR)|0.92||||0.76||95.0|0.34|2.18||Difference between survival curves compared by Log Rank test|Log Rank|||The PCT50 was determined for each patient as the time in minutes/seconds, when the parasite count fell by 50% The PCT50 was appropriately summarised for each treatment for the FAS . The times were presented graphically for each endpoint using a life-table curve (Kaplan-Meier method). For each endpoint the survival curves were compared by the log-rank test. The hazard ratio was calculated along with its 95% CI.|
1695363|NCT01047436|3117562|Superiority or Other||Hazard Ratio (HR)|1.05||||0.7|2-Sided|95.0|0.48|3.01|||Log Rank|||The time for the parasite count to fall by 90% (PCT90) was determined for each patient as the time in minutes/seconds, when the parasite count fell by 90% The PCT90 was appropriately summarised for each treatment for the FAS . The times were presented graphically for each endpoint using a life-table curve (Kaplan-Meier method). For each endpoint the survival curves were compared by the log-rank test. The hazard ratio was calculated along with its 95% CI.|
1695364|NCT01047436|3117564|Superiority or Other||difference between treatments|26.7||||0.17|2-Sided|95.0|-0.3|53.7|||Fisher Exact|||The sample size was not statistically determined in this initial trial with ArTimist. For the primary outcome analysis, the percentage of patients defined as having success were determined. The difference between ArTiMist and quinine, along with its 95% confidence interval (CI) were determined. The difference between treatments were compared using Fisher’s Exact test|
1695365|NCT01047345|3117570|Superiority or Other||Seroconversion Rate|99.8|||<|0.001|2-Sided|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 58|
1695366|NCT01047345|3117570|Superiority or Other||Seroconversion Rate|99.6|||<|0.001|2-Sided|95.0|98.6|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 52|
1695367|NCT01047345|3117570|Superiority or Other||Seroconversion Rate|98.3|||<|0.001|2-Sided|95.0|96.7|99.2||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 45|
1695368|NCT01047345|3117570|Superiority or Other||Seroconversion Rate|99.8|||<|0.001|2-Sided|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% CI for the proportion of subjects seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 33|
1695369|NCT01047345|3117570|Superiority or Other||Seroconversion rate|99.8|||<|0.001|2-Sided|95.0|98.9|100.0||statistical criterion of acceptability required that the lower bound of the 95% confidence interval (CI) for the proportion of participants seroconverting be greater than 90%|Clopper-Pearson|||Anti-HPV 31|
1695370|NCT01047345|3117571|Superiority or Other||Difference in Percentages|10.2|||||2-Sided|95.0|7.5|13.1|||||||
1695371|NCT01047345|3117572|Superiority or Other||Difference in Percentages|-0.2|||||2-Sided|95.0|-1.7|0.6|||||||
1695372|NCT01047345|3117573|Superiority or Other||Difference in Percentages|0.0|||||2-Sided|95.0|-1.5|0.9|||||||
1695373|NCT01047345|3117574|Superiority or Other||Difference in Percentages|4.0|||||2-Sided|95.0|-2.8|10.8|||||||
1695374|NCT01047345|3117575|Superiority or Other||Difference in Percentages|3.5||||0.026|2-Sided|95.0|0.5|6.2|||Miettinen & Nurminen||||
1695375|NCT01047332|3117579|Other|||||||0.997|||||||Log Rank||||
1695376|NCT01047332|3117580|Other|||||||0.53|||||||Log Rank||||
1695377|NCT01047189|3117629|Superiority or Other|||||||0.05|||||||Kruskal-Wallis||||
1695378|NCT01046695|3117656|Superiority or Other|||||||0.7|||||||t-test, 2 sided||||
1695379|NCT01046695|3117657|Superiority or Other|||||||0.11|||||||t-test, 2 sided|||Decrease in OME use in the Control Arm during the first and second 24 hours.|
1695380|NCT01046695|3117657|Superiority or Other|||||||0.005|||||||t-test, 2 sided|||Decrease in OME use in the TENS Unit during the first and second 24 hours.|
1695381|NCT01046682|3117658|Superiority or Other||||||<|0.05|||||||Wilcoxon rank sum test|||Using data from a different population, ie, patients with peripheral artery disease, and a different intervention, ie, omega-3 fatty acids, 15 participants were needed per group to achieve 80% power to detect a difference in means of -3.6% (the difference between the control group mean of -0.3% and a treatment group mean of 3.3%) assuming a common standard deviation of 3.3 using a two group t-test with a 0.05 two-sided significance level. 5 patients added to each arm in case nonparametric.|
1695382|NCT01046643|3117660|Superiority or Other|||||||0.726|||||||t-test, 2 sided|||p-value for null hypothesis = <0.05|
1695383|NCT01046643|3117660|Superiority or Other|||||||0.561|||||||t-test, 2 sided|||p-value for null hypothesis = <0.05|
1695384|NCT01046643|3117661|Superiority or Other|||||||0.055||||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = <0.05"|
1695385|NCT01046643|3117661|Superiority or Other|||||||0.158||||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = <0.05"|
1695386|NCT01046643|3117661|Superiority or Other|||||||0.124||||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = <0.05"|
1695387|NCT01046643|3117661|Superiority or Other|||||||0.549||||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = <0.05"|
1695388|NCT01046643|3117661|Superiority or Other|||||||0.868||||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = <0.05"|
1695389|NCT01046643|3117661|Superiority or Other|||||||0.452||||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = <0.05"|
1695390|NCT01046643|3117662|Superiority or Other|||||||0.653|||||||t-test, 2 sided|||p-value for null hypothesis = <0.05|
1695391|NCT01046643|3117662|Superiority or Other|||||||0.594|||||||t-test, 2 sided|||p-value for null hypothesis = <0.05|
1695392|NCT01046643|3117663|Superiority or Other|||||||0.31||||||Category = Right Hippocampus|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = <0.05"|
1695393|NCT01046643|3117663|Superiority or Other|||||||0.385||||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = <0.05"|
1695394|NCT01046643|3117663|Superiority or Other|||||||0.954||||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = <0.05"|
1695395|NCT01046643|3117663|Superiority or Other|||||||0.127||||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Right Hippocampus~p-value for null hypothesis = <0.05"|
1695396|NCT01046643|3117663|Superiority or Other|||||||0.107||||||Category = Left Hippocampus|t-test, 2 sided|||"Category = Left Hippocampus~p-value for null hypothesis = <0.05"|
1695397|NCT01046643|3117663|Superiority or Other|||||||0.222||||||Category = Medial Frontal Cortex|t-test, 2 sided|||"Category = Medial Frontal Cortex~p-value for null hypothesis = <0.05"|
1695398|NCT01046253|3117668|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Slope|98.0|||||2-Sided|90.0|92.8|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1695399|NCT01046253|3117669|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|98.5|||||2-Sided|90.0|93.3|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1695400|NCT01046253|3117670|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.0|||||2-Sided|90.0|97.4|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1695401|NCT01046136|3117671|Superiority or Other|||||||0.0293|||||||Wilcoxon (Mann-Whitney)|P-value is from a Wilcoxon rank sum test comparing the two treatment groups.|||
1695402|NCT01046136|3117673|Superiority or Other|||||||0.0096|||||||Regression, Logistic|p-value is from a logistic regression model with terms for treatment group and center||Investigator's End-of-Study Assessment NOTE: All assessments of efficacy were considered exploratory and were given equal consideration, and were carried out on both the MITT and PP populations. LOCF method was applied to missing post baseline measurements in analyses of the MITT population.|
1695403|NCT01046084|3117676|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|107.0|||||2-Sided|90.0|92.5|123.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1695404|NCT01046084|3117677|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|104.0|||||2-Sided|90.0|89.3|120.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1695405|NCT01046084|3117678|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|103.0|||||2-Sided|90.0|86.5|123.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1695406|NCT01045993|3117679|Superiority or Other||||||<|0.001||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Cochran-Mantel-Haenszel|P-value from the Cochran-Mantel-Haenszel test with modified ridit scores.|||
1695407|NCT01045993|3117680|Superiority or Other|||||||0.034||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)|
1695408|NCT01045993|3117680|Superiority or Other|||||||0.625||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees|
1695409|NCT01045993|3117680|Superiority or Other|||||||0.088||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees|
1695410|NCT01045993|3117681|Superiority or Other|||||||0.294||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)|
1695411|NCT01045993|3117681|Superiority or Other|||||||0.6||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees|
1695412|NCT01045993|3117681|Superiority or Other|||||||0.054||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees|
1695413|NCT01045993|3117682|Superiority or Other|||||||0.216||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-values from ANOVA model with treatment treatment term only in the model.||At Plus 5 degrees (beyond maximum)|
1695414|NCT01045993|3117682|Superiority or Other|||||||0.371||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees|
1695415|NCT01045993|3117682|Superiority or Other|||||||0.355||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees|
1695416|NCT01045993|3117683|Superiority or Other|||||||0.122||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.|||
1695417|NCT01045993|3117684|Superiority or Other|||||||0.371||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.|||
1695418|NCT01045993|3117685|Superiority or Other|||||||0.797||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.|||
1695419|NCT01045993|3117686|Superiority or Other|||||||0.039||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)|
1695420|NCT01045993|3117686|Superiority or Other|||||||0.388||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees|
1695421|NCT01045993|3117686|Superiority or Other|||||||0.043||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees|
1695422|NCT01045993|3117687|Superiority or Other|||||||0.219||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)|
1695423|NCT01045993|3117687|Superiority or Other|||||||0.757||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees|
1695424|NCT01045993|3117687|Superiority or Other|||||||0.067||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees|
1695425|NCT01045993|3117688|Superiority or Other|||||||0.086||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Plus 5 degrees (beyond maximum)|
1695426|NCT01045993|3117688|Superiority or Other|||||||0.419||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Minus 5 degrees|
1695427|NCT01045993|3117688|Superiority or Other|||||||0.268||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||At Maximum degrees|
1695428|NCT01045993|3117689|Superiority or Other|||||||0.004||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||480 minutes timepoint|
1695429|NCT01045993|3117689|Superiority or Other|||||||0.008||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||420 minutes timepoint|
1695430|NCT01045993|3117689|Superiority or Other|||||||0.005||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||360 minutes timepoint|
1695431|NCT01045993|3117689|Superiority or Other|||||||0.002||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||300 minutes timepoint|
1695432|NCT01045993|3117689|Superiority or Other|||||||0.096||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||240 minutes timepoint|
1695433|NCT01045993|3117689|Superiority or Other|||||||0.033||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||180 minutes timepoint|
1695718|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|-0.147|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.382|0.088|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Day 1|
1695434|NCT01045993|3117689|Superiority or Other|||||||0.002||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||120 minutes timepoint|
1695435|NCT01045993|3117689|Superiority or Other|||||||0.012||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||60 minutes timepoint|
1695436|NCT01045993|3117690|Superiority or Other|||||||0.001||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||480 minutes timepoint|
1695437|NCT01045993|3117690|Superiority or Other|||||||0.003||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||420 minutes timepoint|
1695438|NCT01045993|3117690|Superiority or Other||||||<|0.001||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||360 minutes timepoint|
1695439|NCT01045993|3117690|Superiority or Other||||||<|0.001||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||300 minutes timepoint|
1695440|NCT01045993|3117690|Superiority or Other||||||<|0.002||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||240 minutes timepoint|
1695441|NCT01045993|3117690|Superiority or Other||||||<|0.001||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||180 minutes timepoint|
1695442|NCT01045993|3117690|Superiority or Other||||||<|0.016||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||120 minutes timepoint|
1695443|NCT01045993|3117690|Superiority or Other||||||<|0.012||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value from ANOVA model with treatment term only in the model.||60 minutes timepoint|
1695444|NCT01045993|3117692|Superiority or Other|||||||0.002||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value calculated using ANOVA model with treatment term only in the model.|||
1695445|NCT01045993|3117693|Superiority or Other||||||<|0.001||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|ANOVA|P-value calculated using analysis of variance (ANOVA) model with treatment term only in the model.|||
1695446|NCT01045993|3117694|Non-Inferiority or Equivalence|The statistical alternative hypothesis tested is that the survival curves of time to first perceptible relief confirmed by meaningful relief are not identical between two treatment groups, or equivalently, the hazard ratio between two treatment groups is not equal to 1.||||||0.046||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Proportional hazards regression model|P-value calculated using proportional hazards model with treatment term only in the model.|||
1695447|NCT01045993|3117695|Superiority or Other|||||||0.046||||||Statistically significant treatment difference was declared if the probability of random occurrence between the treatment groups p-value was ≤0.05.|Proportional hazards regression model|P-value calculated using proportional hazards model with treatment term only in the model.|||
1695448|NCT01045967|3117696|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.4|||||2-Sided|90.0|86.3|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1695449|NCT01045967|3117697|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|97.2|||||2-Sided|90.0|86.1|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1695450|NCT01045967|3117698|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|105.0|||||2-Sided|90.0|90.7|122.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1695451|NCT01045551|3117712|Superiority or Other||Mean Difference (Net)|0.09|Standard Deviation|0.9024|||2-Sided||||||||||
1695452|NCT01045551|3117713|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.98|2-Sided|||||The a priori threshold for statistical significance was P<0.05.|t-test, 2 sided||||
1695453|NCT01045161|3117750|Superiority or Other||Least Squares Mean difference|0.072||||0.0012|2-Sided|95.0|0.03|0.12|||ANCOVA||||
1695454|NCT01045161|3117750|Superiority or Other||Least Squares Mean Difference|0.051||||0.0192|2-Sided|95.0|0.01|0.09|||ANCOVA||||
1695457|NCT01045096|3117762|Superiority or Other||Dose Proportionality Point Estimate|1.19|||||2-Sided|95.0|0.777|1.817||||||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC[0-24]. Pairwise comparisons between regimens were conducted.|
1695458|NCT01045096|3117762|Superiority or Other||Dose Proportionality Point Estimate|1.26|||||2-Sided|90.0|0.691|2.314||||||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC[0-24]. Pairwise comparisons between regimens were conducted.|
1695459|NCT01045096|3117762|Superiority or Other||Dose Proportionality Point Estimate|1.06|||||2-Sided|90.0|0.692|1.636||||||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC[0-24]. Pairwise comparisons between regimens were conducted.|
1695460|NCT01045096|3117763|Superiority or Other||Dose Proportionality Point Estimate|1.02|||||2-Sided|90.0|0.632|1.642||||||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC[0-tlqc]. Pairwise comparisons between regimens were conducted.|
1695461|NCT01045096|3117763|Superiority or Other||Dose Proportionality Point Estimate|1.15|||||2-Sided|90.0|0.584|2.276||||||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC[0-tlqc]. Pairwise comparisons between regimens were conducted.|
1695462|NCT01045096|3117763|Superiority or Other||Dose Proportionality Point Estimate|1.13|||||2-Sided|90.0|0.693|1.848||||||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized AUC[0-tlqc]. Pairwise comparisons between regimens were conducted.|
1695463|NCT01045096|3117764|Superiority or Other||Dose Proportionality Point Estimate|0.88|||||2-Sided|90.0|0.493|1.579||||||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.|
1695464|NCT01045096|3117764|Superiority or Other||Dose proportionality Point Estimate|1.06|||||2-Sided|90.0|0.463|2.427||||||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.|
1695465|NCT01045096|3117764|Superiority or Other||Dose Proportionality Point Estimate|1.2|||||2-Sided|90.0|0.66|2.183||||||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An ANCOVA model with weight as a covariate and regimen as a factor were fitted to dose-normalized Cmax. Pairwise comparisons between regimens were conducted.|
1695466|NCT01045096|3117765|Superiority or Other|||||||0.809|||||||ANCOVA|||Sample size of 12 participants per dose group, along with the intense PK sampling in each regimen was needed for characterization of the PK profile. An analysis of variance with covariates (ANCOVA) model with weight as a covariate and regimen as a factor were fitted to Tmax. Pairwise comparisons between regimens were conducted.|
1695467|NCT01044706|3117793|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p<0.05).|ratio of T/R geometric mean x 100|110.5|Standard Error of the Mean|0.0281|<|0.05|2-Sided|95.0|105.43|115.82||Differences were declared statistically significant at the 5% level (p<0.05).|ANOVA|degrees of freedom 56|Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.|Using GLM procedures in SAS, ANOVA was performed on ln-transformed Cmax at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for Cmax.|
1695468|NCT01044706|3117794|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference produts. Differences were declared statistically significant at the 5% level (p<0.05).|ratio of T/R geometric mean x 100|108.46|Standard Error of the Mean|0.0321|<|0.05|2-Sided|90.0|102.79|114.44||Differences were declared statistically significant at the 5% level (p<0.05).|ANOVA|degrees of freedom 55|Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean for AUCO-144 and Cmax between the test and reference product fall within the interval of 80-125%.|Using GLM procedures in SAS, ANOVA was performed on ln-transformed AUC0-144 at the alpha level of 0.05. Factors incorporated in the model will include: Group, Treatment and Treatment*Group. Intra-subject coefficient of variation (CV%) will be estimated. The ratio of means (T/R) and 90% geometric confidence interval for the ratio of means, based on least-squares means from the ANOVA of the ln-transformed data, will be calculated for AUC0-144 hour.|
1695469|NCT01044693|3117795|Superiority or Other|||||||0.996|||||||Wilcoxon (Mann-Whitney)|||The main comparisons were between the negative chronotropic effect of nebivolol and metoprolol at the time when BP-lowering effects were maximal.|
1695470|NCT01044693|3117796|Superiority or Other|||||||0.597|||||||ANOVA|||The main comparisons were between the active treatment groups versus placebo.|
1695471|NCT01044693|3117797|Superiority or Other|||||||0.607|||||||ANOVA|||The main comparisons were between the active treatment groups versus placebo.|
1695472|NCT01044693|3117798|Superiority or Other||||||>|0.05|||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.|
1696405|NCT01033942|3118846|Superiority or Other|||||||0.0945|||||||Fisher Exact||||
1695473|NCT01044693|3117798|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.|
1695474|NCT01044693|3117798|Superiority or Other||||||<|0.036|||||||Mixed Models Analysis|||The main comparisons were between the active treatment groups versus placebo. We hypothesized that if NO-mediated vasodilation contributes to the BP-lowering effect of nebivolol then BP will be lowered by nebivolol and sildenafil, but not by metoprolol in autonomic failure patients.|
1695475|NCT01044290|3117839|Superiority or Other||Mean Difference (Net)|1.4|||=|0|2-Sided|95.0|-0.03|2.7|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable. Sex item omitted from scale.||Comparison at 5 weeks.|
1695476|NCT01044290|3117839|Superiority or Other||Mean Difference (Net)|0.4|||<|0.57|2-Sided|95.0|-1.0|1.8|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable. Sex item omitted from scale.||Comparison at 5 weeks.|
1695477|NCT01044290|3117840|Superiority or Other||Mean Difference (Final Values)|1.6|||<|0.05|2-Sided|95.0|0.05|3.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks|
1695478|NCT01044290|3117840|Superiority or Other||Mean Difference (Final Values)|0.9|||<|0.25|2-Sided|95.0|-0.6|2.4|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks|
1695479|NCT01044290|3117841|Superiority or Other||Mean Difference (Net)|0.04|||<|0.97|2-Sided|95.0|-2.1|2.2|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks.|
1695480|NCT01044290|3117841|Superiority or Other||Mean Difference (Net)|0.6|||=|0|2-Sided|95.0|-1.5|2.8|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks|
1695481|NCT01044290|3117842|Superiority or Other||Mean Difference (Net)|-0.6|||=|0|2-Sided|95.0|-2.1|0.9|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks|
1695482|NCT01044290|3117842|Superiority or Other||Mean Difference (Net)|0.1|||<|0.91|2-Sided|95.0|-1.4|1.5|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks|
1695483|NCT01044290|3117843|Superiority or Other||Mean Difference (Net)|-0.02|||<|0.97|2-Sided|95.0|-1.2|1.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable||Comparison at 5 weeks.|
1695484|NCT01044290|3117843|Superiority or Other||Mean Difference (Net)|-0.1|||=|0|2-Sided|95.0|-1.2|1.1|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks|
1695485|NCT01044290|3117844|Superiority or Other||Mean Difference (Net)|1.1|||<|0.02|2-Sided|95.0|0.2|2.0|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks.|
1695486|NCT01044290|3117844|Superiority or Other||Mean Difference (Net)|-0.2|||<|0.61|2-Sided|95.0|-1.1|0.7|||Mixed Models Analysis|Adjusted for Palliative Performance Scale (low versus high) stratification variable.||Comparison at 5 weeks|
1695487|NCT01044264|3117845|Non-Inferiority or Equivalence|BE of the test to reference in the per protocol population|Wilcoxon Rank Sum Test|100.0|||||2-Sided|90.0|92.47|113.54|||||||
1695488|NCT01044030|3117857|Superiority or Other|||||||0.6|||||||Chi-squared||||
1695489|NCT01043939|3117858|Superiority or Other||Ratio of means|1.34||||0.37|2-Sided|95.0|0.69|2.62|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period & group as fixed effects.|hs-CRP was log transformed prior to analyses; the difference of log-transformed least square means (95% CI) were back-transformed to obtain the ratio of the means (95% CI).||
1695490|NCT01043939|3117859|Superiority or Other||Ratio of means|0.92||||0.15|2-Sided|95.0|0.82|1.03|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period & group as fixed effects.|MPO was log transformed prior to analyses; the difference of log-transformed least square means (95% CI) were back-transformed to obtain the ratio of the means (95% CI).||
1695491|NCT01043939|3117860|Superiority or Other||Difference of least square means|3.09||||0.29|2-Sided|95.0|-2.73|8.91|||Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period & group as fixed effects.|||
1695492|NCT01043939|3117861|Superiority or Other||Difference of least square means|-0.16||||0.25|2-Sided|95.0|-0.42|0.11||24 participants required to achieve 80% power to detect mean difference of 0.3 in RH-PAT index score between juice groups, assuming standard deviation of the difference was 0.25, using a two-sided significance level of 0.05|Mixed Models Analysis|Mixed effects ANCOVA model with baseline included as a covariate, subject as a random effect; juice, period & group as fixed effects.|The a priori threshold for statistical significance was 0.05.||
1695493|NCT01043926|3117865|Non-Inferiority or Equivalence|"Cmax GMR = Cmax GM for Moderate Hepatic Insufficiency Participants ÷ Cmax GM for Healthy Participants~A 90% CI for the Cmax GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the upper limit bound of the 90% CI for the Cmax GMR fell below 2.00, then the hypothesis would be met and the Cmax of suvorexant would be similar in both groups of participants. That is, if the true ratio of the geometric mean Cmax is no more than 2.00."|Cmax Geometric Mean Ratio|0.94|||||2-Sided|90.0|0.68|1.29||||||"The GM for each participant group and the corresponding 95% CI were calculated for Cmax using an ANCOVA model.~The Cmax GMR of the 2 participant groups was used to test the primary hypothesis, which was that the Cmax of suvorexant following a single 20-mg oral dose would be similar between participants with moderate hepatic insufficiency and healthy matched control participants."|
1695515|NCT01042938|3117930|Superiority or Other||Mean Difference (Final Values)|0.2||||0.7|2-Sided|95.0|-0.7|1.1|||ANCOVA|||Hypohesis: There is a signifcant difference in affective subscale pain scores between curcumin and placebo groups.|
1695516|NCT01042938|3117930|Superiority or Other||Mean Difference (Final Values)|1.5||||0.152|2-Sided|95.0|-0.6|3.6|||ANCOVA|||Hypothesis: There is a significant difference in mean sensory subscale pain scores between curcumin and placebo groups.|
1695494|NCT01043926|3117866|Non-Inferiority or Equivalence|"AUC(0-∞) GMR = AUC(0-∞) GM for Moderate Hepatic Insufficiency Participants ÷ AUC(0-∞) GM for Healthy Participants~A 90% CI for the AUC(0-∞) GMR was computed from the ANCOVA model. As prespecified by the analysis plan, if the upper limit bound of the 90% CI for the AUC(0-∞) GMR fell below 2.00, then the hypothesis would be met and the AUC(0-∞) of suvorexant would be similar in both groups of participants. That is, if the true ratio of the GM AUC(0-∞) is no more than 2.00."|AUC(0-∞) Geometric Mean Ratio|1.03|||||2-Sided|90.0|0.74|1.43||||||"The geometric mean (GM) for each participant group and the corresponding 95% confidence interval (CI) were calculated for AUC(0-∞) using an analysis of covariance (ANCOVA) model.~The AUC(0-∞) geometric mean ratio (GMR) of the 2 participant groups was used to test the primary hypothesis, which was that the AUC(0-∞) of suvorexant following a single 20-mg oral dose would be similar between participants with moderate hepatic insufficiency and healthy matched control participants."|
1695495|NCT01043705|3117871|Superiority or Other||Descriptive|5.4||||0.0745|2-Sided|95.0|3.7|7.5|||Chi-squared|||All mechanical complications, retrospective, non-TYRX cohort|
1695496|NCT01043705|3117871|Superiority or Other||rate compared to performance goal|5.4||||0.0006|2-Sided|95.0|3.8|5.4|||1-sided Chi-squared test|||All types of mechanical complications combined.|
1695497|NCT01043705|3117871|Superiority or Other||Rate compared to a performance goal|3.1||||0.0444|2-Sided|95.0|1.7|5.1|||1-sided Chi-square test||||
1695498|NCT01043705|3117871|Superiority or Other||Rate compared to performance goal|4.4||||0.0005|2-Sided|95.0|3.3|5.8|||1-sided Chi-square||||
1695499|NCT01043705|3117872|Superiority or Other||Fisher's Exact Test|0.7||||0.3764|2-Sided|95.0|||||Fisher Exact||||
1695500|NCT01043705|3117872|Superiority or Other||1-sided Fisher's Exact Test|0.006||||0.0176|1-Sided|95.0||0.014|||Fisher Exact||||
1695501|NCT01043705|3117872|Superiority or Other||1-sided Fisher's Exact Text|0.002||||0.0052|1-Sided|95.0||0.01|||Fisher Exact||||
1695502|NCT01043705|3117872|Superiority or Other||One sided Fisher's exact test.|0.0044||||0.0023|1-Sided|95.0||0.009|||Fisher Exact||||
1695503|NCT01043432|3117910|Superiority or Other||||||>|0.05|||||||Regression, Linear|||Linear regressions were utilized to model the outcomes of interest as a function of SA, TBI group, and the interaction between the two groups.|
1695504|NCT01043393|3117913|Superiority or Other||Odds Ratio (OR)|0.779|||||2-Sided|95.0|0.055|11.126|||||||
1695505|NCT01043133|3117919|Superiority or Other||Mean Difference (Final Values)|-1.25|Standard Deviation|2.78||0.05|2-Sided|95.0|-2.48|-0.03|||ANCOVA||||
1695506|NCT01043133|3117920|Superiority or Other||log-binomial|3.97|Standard Error of the Mean|3.97||0.01|2-Sided|95.0|1.34|11.79|||log-binomial regression||Robust Huber-White standard errors account for clustering||
1695507|NCT01042977|3117923|Superiority or Other||Mean Difference (Final Values)|-3.44|Standard Error of the Mean|0.9746||0.0004|2-Sided|95.0|-5.35|-1.53||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1695508|NCT01042977|3117924|Superiority or Other||Mean Difference (Final Values)|-3.02|Standard Error of the Mean|0.7983||0.0002|2-Sided|95.0|-4.59|-1.46||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1695509|NCT01042977|3117925|Superiority or Other||Mean Difference (Final Values)|-2.71|Standard Error of the Mean|0.7977||0.0007|2-Sided|95.0|-4.28|-1.15||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1695510|NCT01042977|3117926|Superiority or Other||Risk Difference (RD)|13.6|Standard Error of the Mean|2.149|<|0.0001|2-Sided|95.0|9.4|17.8||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline total body weight and age stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0|
1695511|NCT01042977|3117927|Superiority or Other||Mean Difference (Final Values)|-1.93|Standard Error of the Mean|0.1957|<|0.0001|2-Sided|95.0|-2.31|-1.54||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1695512|NCT01042977|3117928|Superiority or Other||Risk Difference (RD)|7.0|||<|0.0001|2-Sided|95.0|4.3|9.8||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives|Cochran-Mantel-Haenszel|with age-by-insulin use-by-time from most recent qualifying CV event as stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0|
1695513|NCT01042977|3117929|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.0489|<|0.0001|2-Sided|95.0|-0.5|-0.3||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives|ANCOVA|with treatment group and stratum as effects and baseline value as covariate for each endpoint|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1695514|NCT01042938|3117930|Superiority or Other||Mean Difference (Final Values)|0.2||||0.559|2-Sided|95.0|-0.4|0.7|||ANCOVA|||Hypothesis: There is a significant difference in mean perceived pain scores between curcumin and placebo groups.|
1696166|NCT01036022|3118548|Superiority or Other||Ratio|1.64|||||2-Sided|95.0|0.46|5.91||||||Placebo versus GSK1399686 300 mg for Week 6 fecal lactoferrin levels|
1695517|NCT01042938|3117930|Superiority or Other||Mean Difference (Final Values)|1.685||||0.218|2-Sided|95.0|-1.059|4.428|||ANCOVA|||Hypothesis: There is a significant difference in mean MPQ pain scores between the curcumin and placebo groups.|
1695518|NCT01042938|3117931|Superiority or Other|||||||0.145|||||||ANOVA|||Hypothesis: There is a significant difference in mean redness (i.e., mean a* number value) between the curcumin and placebo groups.|
1695519|NCT01042938|3117932|Superiority or Other|||||||0.0022|||||||Fisher Exact|||Hypothesis: The presence of moist desquamation significantly differed between the curcumin group and the placebo group.|
1695520|NCT01042938|3117933|Superiority or Other||Mean Difference (Final Values)|-0.7991|Standard Deviation|0.7606||0.0077|2-Sided|95.0|-1.3693|-0.2289|||Standard pooled variances t-test|||Hypothesis: The mean RDS for curcumin group is significantly different (i.e., lower) than mean RDS of placebo group at end of radiation treatment.|
1695521|NCT01042613|3117941|Superiority or Other||Mean Difference (Final Values)|0.07||||0.8||95.0|||||Wilcoxon (Mann-Whitney)||||
1695522|NCT01042613|3117942|Superiority or Other||Mean Difference (Final Values)|0.22||||0.105||95.0|||||Wilcoxon (Mann-Whitney)||||
1695523|NCT01042613|3117943|Superiority or Other||Difference of the Binomial Proportions|0.02||||0.851||95.0|||||Fisher Exact||||
1695524|NCT01042236|3117988|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.12||0.1271|2-Sided|95.0|-0.43|0.06||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.|
1695525|NCT01042236|3117988|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.12||0.8602|2-Sided|95.0|-0.26|0.22||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.|
1695526|NCT01042236|3117989|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.12||0.1881|2-Sided|95.0|-0.42|0.09||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.|
1695527|NCT01042236|3117989|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.12||0.9403|2-Sided|95.0|-0.24|0.26||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.|
1695528|NCT01042236|3117990|Superiority or Other||Mean Difference (Final Values)|-0.78|Standard Error of the Mean|0.94||0.4167|2-Sided|95.0|-2.71|1.15||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.|
1695529|NCT01042236|3117990|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.94||0.987|2-Sided|95.0|-1.91|1.94||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.|
1695530|NCT01042236|3117991|Superiority or Other||Median Difference (Final Values)|-0.47|Standard Error of the Mean|0.88||0.5944|2-Sided|95.0|-2.27|1.32||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.|
1695531|NCT01042236|3117991|Superiority or Other||Mean Difference (Final Values)|0.61|Standard Error of the Mean|0.88||0.4907|2-Sided|95.0|-1.18|2.41||A treatment by period interaction term (fixed effect) was included if significant at 10% significance level.|ANCOVA|||Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect.|
1695532|NCT01042145|3117996|Superiority or Other|||||||1|||||||Fisher Exact||||
1695533|NCT01042145|3117997|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)||||
1695534|NCT01042145|3117998|Superiority or Other|||||||0.51|||||||Wilcoxon (Mann-Whitney)||||
1695535|NCT01042145|3118000|Superiority or Other|||||||0.63|||||||Wilcoxon (Mann-Whitney)||||
1695536|NCT01042145|3118001|Superiority or Other|||||||0.34|||||||Fisher Exact||||
1695537|NCT01041976|3118005|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1695538|NCT01041976|3118006|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1695571|NCT01040793|3118123|Superiority or Other||Mean Difference (Final Values)|0.029|Standard Error of the Mean|0.056||0.608||95.0|-0.081|0.138|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695572|NCT01040793|3118123|Superiority or Other||Mean Difference (Final Values)|0.057|Standard Error of the Mean|0.056||0.3109||95.0|-0.053|0.166|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1696406|NCT01033942|3118847|Superiority or Other|||||||0.0288|||||||Fisher Exact||||
1695539|NCT01041859|3118011|Superiority or Other||Mean Difference (Final Values)|-0.95|Standard Error of the Mean|0.234|<|0.001|2-Sided|95.0|-1.415|-0.493||Analysis of covariance (ANCOVA) model was used with treatment, dose level, and pooled analysis center as factors and baseline pain intensity score as a covariate|ANCOVA||Mean Difference is least squares mean change in DB Tapentadol ER group minus least squares mean change in DB Placebo group (based on ANCOVA model)|The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 1.0 with an SD of 2.6, 144 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a DB treatment group for the study was 300.|
1695540|NCT01041781|3118012|Superiority|||||||0.0322|||||||Log Rank||||
1695541|NCT01041781|3118013|Superiority|||||||0.0131|||||||Log Rank||||
1695542|NCT01041781|3118014|Superiority|||||||0.0049|||||||Log Rank||||
1695543|NCT01041781|3118018|Superiority||Hazard Ratio (HR)|1.076||||0.5346|2-Sided|95.0|0.853|1.367|||Log Rank||||
1695544|NCT01041573|3118027|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1695545|NCT01041573|3118027|Superiority or Other||||||<|0.641|||||||Fisher Exact||||
1695546|NCT01041404|3118055|Superiority or Other||Hazard Ratio (HR)|0.74||||0.0046|2-Sided|95.0|0.6|0.91|||Log Rank||||
1695547|NCT01041404|3118056|Superiority or Other||Odds Ratio (OR)|1.66|||||2-Sided|95.0|1.14|2.41|||||||
1695548|NCT01041404|3118056|Superiority or Other||Difference in Clinical Benefit Rate|9.6||||0.0081|2-Sided|95.0|2.4|16.9|||Chi-squared||||
1695549|NCT01041404|3118057|Superiority or Other||Hazard Ratio (HR)|0.54|||<|0.0001|2-Sided|95.0|0.4|0.73|||Log Rank||||
1695550|NCT01041404|3118059|Superiority or Other||Difference in Response Rates|12.8||||0.0017|2-Sided|95.0|4.7|20.9|||Chi-squared||||
1695551|NCT01041404|3118060|Superiority or Other||Hazard Ratio (HR)|0.7||||0.0003|2-Sided|95.0|0.58|0.85|||Log Rank||||
1695552|NCT01041404|3118062|Superiority or Other||Hazard Ratio (HR)|0.71||||0.0002|2-Sided|95.0|0.59|0.85|||Log Rank||||
1695553|NCT01040871|3118082|Superiority or Other||Odds Ratio (OR)|1.038||||0.915|2-Sided|95.0|0.529|2.037|||Cochran-Mantel-Haenszel|Stratified by IPI score|Odds ratio: VR-CAP CR rate relative to R-CHOP CR rate||
1695554|NCT01040832|3118107|Superiority or Other|||||||0.557|||||||Cochran-Mantel-Haenszel||||
1695555|NCT01040832|3118108|Superiority or Other||||||>|0.999|||||||Cochran-Mantel-Haenszel||||
1695556|NCT01040832|3118109|Superiority or Other||Hazard Ratio (HR)|1.1||||0.793|2-Sided|95.0|0.7|1.6|||Stratified log rank||||
1695557|NCT01040793|3118116|Superiority or Other||Mean Difference (Final Values)|0.552|Standard Error of the Mean|0.071|<|0.0001||95.0|0.412|0.691|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695558|NCT01040793|3118116|Superiority or Other||Mean Difference (Final Values)|0.58|Standard Error of the Mean|0.07|<|0.0001||95.0|0.441|0.719|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695559|NCT01040793|3118117|Superiority or Other||Mean Difference (Final Values)|0.291|Standard Error of the Mean|0.063|<|0.0001||95.0|0.166|0.416|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695560|NCT01040793|3118117|Superiority or Other||Mean Difference (Final Values)|0.281|Standard Error of the Mean|0.063|<|0.0001||95.0|0.156|0.405|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695561|NCT01040793|3118118|Superiority or Other||Mean Difference (Final Values)|0.281|Standard Error of the Mean|0.035|<|0.0001||95.0|0.212|0.35|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695562|NCT01040793|3118118|Superiority or Other||Mean Difference (Final Values)|0.265|Standard Error of the Mean|0.035|<|0.0001||95.0|0.196|0.333|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695563|NCT01040793|3118119|Superiority or Other||Mean Difference (Final Values)|0.119|Standard Error of the Mean|0.037||0.0013||95.0|0.047|0.191|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695564|NCT01040793|3118119|Superiority or Other||Mean Difference (Final Values)|0.119|Standard Error of the Mean|0.036||0.0013||95.0|0.047|0.191|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695565|NCT01040793|3118120|Superiority or Other||Mean Difference (Final Values)|0.195|Standard Error of the Mean|0.021|<|0.0001||95.0|0.153|0.236|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695566|NCT01040793|3118120|Superiority or Other||Mean Difference (Final Values)|0.192|Standard Error of the Mean|0.021|<|0.0001||95.0|0.151|0.233|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695567|NCT01040793|3118121|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.019|<|0.0001||95.0|0.073|0.148|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695568|NCT01040793|3118121|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.019|<|0.0001||95.0|0.073|0.148|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695569|NCT01040793|3118122|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.056||0.858||95.0|-0.1|0.12|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695570|NCT01040793|3118122|Superiority or Other||Mean Difference (Final Values)|0.023|Standard Error of the Mean|0.056||0.6809||95.0|-0.087|0.133|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695573|NCT01040793|3118124|Superiority or Other||Mean Difference (Final Values)|0.203|Standard Error of the Mean|0.036|<|0.0001||95.0|0.133|0.273|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695574|NCT01040793|3118124|Superiority or Other||Mean Difference (Final Values)|0.232|Standard Error of the Mean|0.036|<|0.0001||95.0|0.162|0.303|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695575|NCT01040793|3118125|Superiority or Other||Mean Difference (Final Values)|0.154|Standard Error of the Mean|0.04||0.0001||95.0|0.076|0.233|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695576|NCT01040793|3118125|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.04||0.0002||95.0|0.071|0.228|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695577|NCT01040793|3118126|Superiority or Other||Mean Difference (Final Values)|-0.187|Standard Error of the Mean|0.054||0.0005||95.0|-0.293|-0.082|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695578|NCT01040793|3118126|Superiority or Other||Mean Difference (Final Values)|-0.213|Standard Error of the Mean|0.053|<|0.0001||95.0|-0.318|-0.108|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695579|NCT01040793|3118127|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.053||0.0246||95.0|-0.224|-0.015|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695580|NCT01040793|3118127|Superiority or Other||Mean Difference (Final Values)|-0.086|Standard Error of the Mean|0.053||0.1048||95.0|-0.19|0.018|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695581|NCT01040793|3118128|Superiority or Other||Mean Difference (Final Values)|0.341|Standard Error of the Mean|0.146||0.0198||95.0|0.055|0.628|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695582|NCT01040793|3118128|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.146||0.5313||95.0|-0.196|0.379|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695583|NCT01040793|3118129|Superiority or Other||Mean Difference (Final Values)|-0.025|Standard Error of the Mean|0.069||0.7199||95.0|-0.162|0.112|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695584|NCT01040793|3118129|Superiority or Other||Mean Difference (Final Values)|-0.074|Standard Error of the Mean|0.07||0.2897||95.0|-0.211|0.063|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695585|NCT01040793|3118130|Superiority or Other||Mean Difference (Final Values)|0.172|Standard Error of the Mean|0.034|<|0.0001||95.0|0.105|0.24|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695586|NCT01040793|3118130|Superiority or Other||Mean Difference (Final Values)|0.078|Standard Error of the Mean|0.034|<|0.0245||95.0|0.01|0.146|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695587|NCT01040793|3118131|Superiority or Other||Mean Difference (Final Values)|0.195|Standard Error of the Mean|0.036|<|0.0001||95.0|0.125|0.265|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695588|NCT01040793|3118131|Superiority or Other||Mean Difference (Final Values)|0.164|Standard Error of the Mean|0.036|<|0.0001||95.0|0.094|0.234|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695589|NCT01040793|3118132|Superiority or Other||Mean Difference (Final Values)|-0.066|Standard Error of the Mean|0.214||0.7591||95.0|-0.486|0.355|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695590|NCT01040793|3118132|Superiority or Other||Mean Difference (Final Values)|-0.366|Standard Error of the Mean|0.214||0.1176||95.0|-0.757|0.085|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695591|NCT01040793|3118133|Superiority or Other||Mean Difference (Final Values)|0.166|Standard Error of the Mean|0.034|<|0.0001||95.0|0.098|0.234|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695592|NCT01040793|3118133|Superiority or Other||Mean Difference (Final Values)|0.084|Standard Error of the Mean|0.035|<|0.0155||95.0|0.016|0.152|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695593|NCT01040793|3118134|Superiority or Other||Ratio to placebo|1.105|Standard Error of the Mean|0.039||0.0052||95.0|1.03|1.184|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 10 mcg divided by Placebo||
1695594|NCT01040793|3118134|Superiority or Other||Ratio to placebo|1.118|Standard Error of the Mean|0.04||0.0018||95.0|1.043|1.199|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 5 mcg divided by Placebo||
1695595|NCT01040728|3118141|Superiority or Other||Mean Difference (Final Values)|0.256|Standard Error of the Mean|0.033|<|0.0001||95.0|0.191|0.321|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695596|NCT01040728|3118141|Superiority or Other||Mean Difference (Final Values)|0.216|Standard Error of the Mean|0.033|<|0.0001||95.0|0.15|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695597|NCT01040728|3118141|Superiority or Other||Mean Difference (Final Values)|0.244|Standard Error of the Mean|0.033|<|0.0001||95.0|0.179|0.309|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695598|NCT01040728|3118142|Superiority or Other||Mean Difference (Final Values)|0.378|Standard Error of the Mean|0.031|<|0.0001||95.0|0.316|0.44|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695599|NCT01040728|3118142|Superiority or Other||Mean Difference (Final Values)|0.346|Standard Error of the Mean|0.032|<|0.0001||95.0|0.283|0.408|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695600|NCT01040728|3118142|Superiority or Other||Mean Difference (Final Values)|0.334|Standard Error of the Mean|0.031|<|0.0001||95.0|0.272|0.396|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695601|NCT01040728|3118143|Superiority or Other||Mean Difference (Final Values)|0.37|Standard Error of the Mean|0.029|<|0.0001||95.0|0.314|0.427|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695602|NCT01040728|3118143|Superiority or Other||Mean Difference (Final Values)|0.353|Standard Error of the Mean|0.029|<|0.0001||95.0|0.296|0.411|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695603|NCT01040728|3118143|Superiority or Other||Mean Difference (Final Values)|0.344|Standard Error of the Mean|0.029|<|0.0001||95.0|0.287|0.401|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695604|NCT01040728|3118144|Superiority or Other||Mean Difference (Final Values)|0.262|Standard Error of the Mean|0.03|<|0.0001||95.0|0.202|0.322|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695605|NCT01040728|3118144|Superiority or Other||Mean Difference (Final Values)|0.366|Standard Error of the Mean|0.03|<|0.0001||95.0|0.306|0.426|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695606|NCT01040728|3118144|Superiority or Other||Mean Difference (Final Values)|0.37|Standard Error of the Mean|0.031|<|0.0001||95.0|0.309|0.43|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695607|NCT01040728|3118145|Superiority or Other||Mean Difference (Final Values)|0.335|Standard Error of the Mean|0.03|<|0.0001||95.0|0.275|0.395|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695608|NCT01040728|3118145|Superiority or Other||Mean Difference (Final Values)|0.283|Standard Error of the Mean|0.031|<|0.0001||95.0|0.222|0.343|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695609|NCT01040728|3118145|Superiority or Other||Mean Difference (Final Values)|0.304|Standard Error of the Mean|0.03|<|0.0001||95.0|0.244|0.363|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695610|NCT01040728|3118146|Superiority or Other||Mean Difference (Final Values)|0.302|Standard Error of the Mean|0.033|<|0.0001||95.0|0.238|0.366|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695611|NCT01040728|3118146|Superiority or Other||Mean Difference (Final Values)|0.264|Standard Error of the Mean|0.033|<|0.0001||95.0|0.2|0.329|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695612|NCT01040728|3118146|Superiority or Other||Mean Difference (Final Values)|0.278|Standard Error of the Mean|0.033|<|0.0001||95.0|0.214|0.342|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695613|NCT01040728|3118147|Superiority or Other||Mean Difference (Final Values)|0.37|Standard Error of the Mean|0.027|<|0.0001||95.0|0.316|0.424|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695614|NCT01040728|3118147|Superiority or Other||Mean Difference (Final Values)|0.326|Standard Error of the Mean|0.028|<|0.0001||95.0|0.272|0.381|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695615|NCT01040728|3118147|Superiority or Other||Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.028|<|0.0001||95.0|0.276|0.384|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695616|NCT01040728|3118148|Superiority or Other||Mean Difference (Final Values)|0.158|Standard Error of the Mean|0.019|<|0.0001||95.0|0.12|0.195|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695617|NCT01040728|3118148|Superiority or Other||Mean Difference (Final Values)|0.143|Standard Error of the Mean|0.019|<|0.0001||95.0|0.105|0.181|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695714|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|-0.113|Standard Error of the Mean|0.121|||2-Sided|95.0|-0.35|0.124|||||Difference calculated as T+O 2.5/10 minus Olo 10|Day 1|
1695618|NCT01040728|3118148|Superiority or Other||Mean Difference (Final Values)|0.134|Standard Error of the Mean|0.019|<|0.0001||95.0|0.097|0.171|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695619|NCT01040728|3118149|Superiority or Other||Mean Difference (Final Values)|0.244|Standard Error of the Mean|0.019|<|0.0001||95.0|0.205|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695620|NCT01040728|3118149|Superiority or Other||Mean Difference (Final Values)|0.243|Standard Error of the Mean|0.02|<|0.0001||95.0|0.205|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695621|NCT01040728|3118149|Superiority or Other||Mean Difference (Final Values)|0.208|Standard Error of the Mean|0.019|<|0.0001||95.0|0.169|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695622|NCT01040728|3118150|Superiority or Other||Mean Difference (Final Values)|0.175|Standard Error of the Mean|0.018|<|0.0001||95.0|0.138|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695623|NCT01040728|3118150|Superiority or Other||Mean Difference (Final Values)|0.266|Standard Error of the Mean|0.018|<|0.0001||95.0|0.23|0.302|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695624|NCT01040728|3118150|Superiority or Other||Mean Difference (Final Values)|0.237|Standard Error of the Mean|0.018|<|0.0001||95.0|0.201|0.273|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695625|NCT01040728|3118151|Superiority or Other||Mean Difference (Final Values)|0.235|Standard Error of the Mean|0.019|<|0.0001||95.0|0.199|0.271|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695626|NCT01040728|3118151|Superiority or Other||Mean Difference (Final Values)|0.245|Standard Error of the Mean|0.019|<|0.0001||95.0|0.208|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695627|NCT01040728|3118151|Superiority or Other||Mean Difference (Final Values)|0.214|Standard Error of the Mean|0.019|<|0.0001||95.0|0.178|0.251|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695628|NCT01040728|3118152|Superiority or Other||Mean Difference (Final Values)|0.152|Standard Error of the Mean|0.017|<|0.0001||95.0|0.119|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695629|NCT01040728|3118152|Superiority or Other||Mean Difference (Final Values)|0.238|Standard Error of the Mean|0.017|<|0.0001||95.0|0.205|0.272|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695630|NCT01040728|3118152|Superiority or Other||Mean Difference (Final Values)|0.214|Standard Error of the Mean|0.017|<|0.0001||95.0|0.181|0.248|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695631|NCT01040728|3118153|Superiority or Other||Mean Difference (Final Values)|0.192|Standard Error of the Mean|0.017|<|0.0001||95.0|0.159|0.226|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695632|NCT01040728|3118153|Superiority or Other||Mean Difference (Final Values)|0.191|Standard Error of the Mean|0.017|<|0.0001||95.0|0.157|0.225|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695633|NCT01040728|3118153|Superiority or Other||Mean Difference (Final Values)|0.175|Standard Error of the Mean|0.017|<|0.0001||95.0|0.141|0.208|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695634|NCT01040728|3118154|Superiority or Other||Mean Difference (Final Values)|0.164|Standard Error of the Mean|0.018|<|0.0001||95.0|0.128|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695635|NCT01040728|3118154|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.018|<|0.0001||95.0|0.134|0.205|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695636|NCT01040728|3118154|Superiority or Other||Mean Difference (Final Values)|0.153|Standard Error of the Mean|0.018|<|0.0001||95.0|0.117|0.188|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695637|NCT01040728|3118155|Superiority or Other||Mean Difference (Final Values)|0.221|Standard Error of the Mean|0.017|<|0.0001||95.0|0.187|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695638|NCT01040728|3118155|Superiority or Other||Mean Difference (Final Values)|0.221|Standard Error of the Mean|0.018|<|0.0001||95.0|0.186|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695715|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|-0.282|Standard Error of the Mean|0.121|||2-Sided|95.0|-0.519|-0.045|||||Difference calculated as T+O 1.25/10 minus Olo 10|Day 1|
1695639|NCT01040728|3118155|Superiority or Other||Mean Difference (Final Values)|0.197|Standard Error of the Mean|0.017|<|0.0001||95.0|0.163|0.231|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695640|NCT01040689|3118157|Superiority or Other||Mean Difference (Final Values)|0.129|Standard Error of the Mean|0.036||0.0003||95.0|0.059|0.199|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695641|NCT01040689|3118157|Superiority or Other||Mean Difference (Final Values)|0.212|Standard Error of the Mean|0.036|<|0.0001||95.0|0.143|0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695642|NCT01040689|3118157|Superiority or Other||Mean Difference (Final Values)|0.185|Standard Error of the Mean|0.036|<|0.0001||95.0|0.115|0.255|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695643|NCT01040689|3118158|Superiority or Other||Mean Difference (Final Values)|0.295|Standard Error of the Mean|0.04|<|0.0001||95.0|0.217|0.373|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695644|NCT01040689|3118158|Superiority or Other||Mean Difference (Final Values)|0.297|Standard Error of the Mean|0.04|<|0.0001||95.0|0.22|0.375|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695645|NCT01040689|3118158|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.04|<|0.0001||95.0|0.222|0.378|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695646|NCT01040689|3118159|Superiority or Other||Mean Difference (Final Values)|0.302|Standard Error of the Mean|0.036|<|0.0001||95.0|0.231|0.373|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695647|NCT01040689|3118159|Superiority or Other||Mean Difference (Final Values)|0.318|Standard Error of the Mean|0.036|<|0.0001||95.0|0.247|0.388|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695648|NCT01040689|3118159|Superiority or Other||Mean Difference (Final Values)|0.317|Standard Error of the Mean|0.036|<|0.0001||95.0|0.246|0.388|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695649|NCT01040689|3118160|Superiority or Other||Mean Difference (Final Values)|0.215|Standard Error of the Mean|0.031|<|0.0001||95.0|0.153|0.277|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695650|NCT01040689|3118160|Superiority or Other||Mean Difference (Final Values)|0.312|Standard Error of the Mean|0.031|<|0.0001||95.0|0.251|0.374|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695651|NCT01040689|3118160|Superiority or Other||Mean Difference (Final Values)|0.268|Standard Error of the Mean|0.031|<|0.0001||95.0|0.207|0.33|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695652|NCT01040689|3118161|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.031|<|0.0001||95.0|0.168|0.291|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695653|NCT01040689|3118161|Superiority or Other||Mean Difference (Final Values)|0.278|Standard Error of the Mean|0.031|<|0.0001||95.0|0.216|0.339|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695654|NCT01040689|3118161|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.031|<|0.0001||95.0|0.178|0.301|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695655|NCT01040689|3118162|Superiority or Other||Mean Difference (Final Values)|0.184|Standard Error of the Mean|0.033|<|0.0001||95.0|0.118|0.249|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695656|NCT01040689|3118162|Superiority or Other||Mean Difference (Final Values)|0.252|Standard Error of the Mean|0.033|<|0.0001||95.0|0.187|0.318|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695657|NCT01040689|3118162|Superiority or Other||Mean Difference (Final Values)|0.196|Standard Error of the Mean|0.033|<|0.0001||95.0|0.131|0.262|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695658|NCT01040689|3118163|Superiority or Other||Mean Difference (Final Values)|0.276|Standard Error of the Mean|0.034|<|0.0001||95.0|0.21|0.342|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695659|NCT01040689|3118163|Superiority or Other||Mean Difference (Final Values)|0.303|Standard Error of the Mean|0.033|<|0.0001||95.0|0.237|0.368|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695716|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|0.094|Standard Error of the Mean|0.121|||2-Sided|95.0|-0.144|0.332|||||Difference calculated as T+O 5/5 minus T+O 2.5/5|Day 1|
1695660|NCT01040689|3118163|Superiority or Other||Mean Difference (Final Values)|0.282|Standard Error of the Mean|0.034|<|0.0001||95.0|0.216|0.348|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695661|NCT01040689|3118164|Superiority or Other||Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.019|<|0.0001||95.0|0.06|0.134|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695662|NCT01040689|3118164|Superiority or Other||Mean Difference (Final Values)|0.147|Standard Error of the Mean|0.019|<|0.0001||95.0|0.11|0.184|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695663|NCT01040689|3118164|Superiority or Other||Mean Difference (Final Values)|0.133|Standard Error of the Mean|0.019|<|0.0001||95.0|0.096|0.17|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695664|NCT01040689|3118165|Superiority or Other||Mean Difference (Final Values)|0.201|Standard Error of the Mean|0.023|<|0.0001||95.0|0.156|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695665|NCT01040689|3118165|Superiority or Other||Mean Difference (Final Values)|0.234|Standard Error of the Mean|0.023|<|0.0001||95.0|0.189|0.279|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695666|NCT01040689|3118165|Superiority or Other||Mean Difference (Final Values)|0.213|Standard Error of the Mean|0.023|<|0.0001||95.0|0.168|0.258|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695667|NCT01040689|3118166|Superiority or Other||Mean Difference (Final Values)|0.161|Standard Error of the Mean|0.018|<|0.0001||95.0|0.125|0.197|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695668|NCT01040689|3118166|Superiority or Other||Mean Difference (Final Values)|0.239|Standard Error of the Mean|0.018|<|0.0001||95.0|0.203|0.275|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695669|NCT01040689|3118166|Superiority or Other||Mean Difference (Final Values)|0.213|Standard Error of the Mean|0.018|<|0.0001||95.0|0.177|0.249|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695670|NCT01040689|3118167|Superiority or Other||Mean Difference (Final Values)|0.182|Standard Error of the Mean|0.019|<|0.0001||95.0|0.146|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695671|NCT01040689|3118167|Superiority or Other||Mean Difference (Final Values)|0.215|Standard Error of the Mean|0.018|<|0.0001||95.0|0.179|0.252|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695672|NCT01040689|3118167|Superiority or Other||Mean Difference (Final Values)|0.206|Standard Error of the Mean|0.019|<|0.0001||95.0|0.17|0.243|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695673|NCT01040689|3118168|Superiority or Other||Mean Difference (Final Values)|0.132|Standard Error of the Mean|0.018|<|0.0001||95.0|0.097|0.167|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695674|NCT01040689|3118168|Superiority or Other||Mean Difference (Final Values)|0.213|Standard Error of the Mean|0.018|<|0.0001||95.0|0.178|0.247|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695675|NCT01040689|3118168|Superiority or Other||Mean Difference (Final Values)|0.182|Standard Error of the Mean|0.018|<|0.0001||95.0|0.147|0.216|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695676|NCT01040689|3118169|Superiority or Other||Mean Difference (Final Values)|0.148|Standard Error of the Mean|0.019|<|0.0001||95.0|0.11|0.185|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695677|NCT01040689|3118169|Superiority or Other||Mean Difference (Final Values)|0.192|Standard Error of the Mean|0.019|<|0.0001||95.0|0.155|0.23|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695678|NCT01040689|3118169|Superiority or Other||Mean Difference (Final Values)|0.158|Standard Error of the Mean|0.019|<|0.0001||95.0|0.121|0.196|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695679|NCT01040689|3118170|Superiority or Other||Mean Difference (Final Values)|0.123|Standard Error of the Mean|0.021|<|0.0001||95.0|0.081|0.164|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695680|NCT01040689|3118170|Superiority or Other||Mean Difference (Final Values)|0.178|Standard Error of the Mean|0.021|<|0.0001||95.0|0.136|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695717|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|-0.053|Standard Error of the Mean|0.121|||2-Sided|95.0|-0.291|0.186|||||Difference calculated as T+O 5/5 minus T+O 1.25/5|Day 1|
1695681|NCT01040689|3118170|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.021|<|0.0001||95.0|0.09|0.173|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695682|NCT01040689|3118171|Superiority or Other||Mean Difference (Final Values)|0.173|Standard Error of the Mean|0.02|<|0.0001||95.0|0.133|0.212|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Tio 18 mcg qd minus Placebo||
1695683|NCT01040689|3118171|Superiority or Other||Mean Difference (Final Values)|0.207|Standard Error of the Mean|0.02|<|0.0001||95.0|0.167|0.246|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 10 mcg qd minus Placebo||
1695684|NCT01040689|3118171|Superiority or Other||Mean Difference (Final Values)|0.185|Standard Error of the Mean|0.02|<|0.0001||95.0|0.145|0.224|||Mixed Models Analysis|Adjusted using a mixed model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate.|Olo 5 mcg qd minus Placebo||
1695685|NCT01040624|3118174|Superiority or Other||||||<|0.0001|||||||Chi-squared|One-sided binomial test of univariate probability distributions|||
1695686|NCT01040403|3118177|Superiority or Other||Mean Difference (Final Values)|-0.194|Standard Error of the Mean|0.132|||2-Sided|95.0|-0.453|0.065|||||Difference calculated as T+O 5/10 minus T+O 2.5/10||
1695687|NCT01040403|3118177|Superiority or Other||Mean Difference (Final Values)|0.056|Standard Error of the Mean|0.132|||2-Sided|95.0|-0.202|0.314|||||Difference calculated as T+O 5/10 minus T+O 1.25/10||
1695688|NCT01040403|3118177|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.133|||2-Sided|95.0|-0.01|0.511|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10||
1695689|NCT01040403|3118177|Superiority or Other||Mean Difference (Final Values)|-0.326|Standard Error of the Mean|0.132|||2-Sided|95.0|-0.585|-0.067|||||Difference calculated as T+O 5/10 minus Olo 10||
1695690|NCT01040403|3118177|Superiority or Other||Mean Difference (Final Values)|-0.132|Standard Error of the Mean|0.132|||2-Sided|95.0|-0.39|0.127|||||Difference calculated as T+O 2.5/10 minus Olo 10||
1695691|NCT01040403|3118177|Superiority or Other||Mean Difference (Final Values)|-0.382|Standard Error of the Mean|0.132|||2-Sided|95.0|-0.641|-0.123|||||Difference calculated as T+O 1.25/10 minus Olo 10||
1695692|NCT01040403|3118177|Superiority or Other||Mean Difference (Final Values)|0.292|Standard Error of the Mean|0.133|||2-Sided|95.0|0.031|0.553|||||Difference calculated as T+O 5/5 minus T+O 2.5/5||
1695693|NCT01040403|3118177|Superiority or Other||Mean Difference (Final Values)|0.073|Standard Error of the Mean|0.133|||2-Sided|95.0|-0.189|0.335|||||Difference calculated as T+O 5/5 minus T+O 1.25/5||
1695694|NCT01040403|3118177|Superiority or Other||Mean Difference (Final Values)|-0.219|Standard Error of the Mean|0.132|||2-Sided|95.0|-0.478|0.04|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5||
1695695|NCT01040403|3118177|Superiority or Other||Mean Difference (Final Values)|-0.149|Standard Error of the Mean|0.133|||2-Sided|95.0|-0.409|0.111|||||Difference calculated as T+O 5/5 minus Olo 5||
1695696|NCT01040403|3118177|Superiority or Other||Mean Difference (Final Values)|-0.441|Standard Error of the Mean|0.132|||2-Sided|95.0|-0.7|-0.182|||||Difference calculated as T+O 2.5/5 minus Olo 5||
1695697|NCT01040403|3118177|Superiority or Other||Mean Difference (Final Values)|-0.222|Standard Error of the Mean|0.132|||2-Sided|95.0|-0.481|0.037|||||Difference calculated as T+O 1.25/5 minus Olo 5||
1695698|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|0.061|Standard Error of the Mean|0.116|||2-Sided|95.0|-0.166|0.289|||||Difference calculated as T+O 5/10 minus T+O 2.5/10|Day 29|
1695699|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|-0.054|Standard Error of the Mean|0.116|||2-Sided|95.0|-0.281|0.173|||||Difference calculated as T+O 5/10 minus T+O 1.25/10|Day 29|
1695700|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|-0.115|Standard Error of the Mean|0.117|||2-Sided|95.0|-0.345|0.115|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Day 29|
1695701|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|0.118|Standard Error of the Mean|0.116|||2-Sided|95.0|-0.11|0.346|||||Difference calculated as T+O 5/10 minus Olo 10|Day 29|
1695702|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|0.057|Standard Error of the Mean|0.116|||2-Sided|95.0|-0.171|0.285|||||Difference calculated as T+O 2.5/10 minus Olo 10|Day 29|
1695703|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|0.172|Standard Error of the Mean|0.116|||2-Sided|95.0|-0.056|0.4|||||Difference calculated as T+O 1.25/10 minus Olo 10|Day 29|
1695704|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|-0.178|Standard Error of the Mean|0.117|||2-Sided|95.0|-0.408|0.052|||||Difference calculated as T+O 5/5 minus T+O 2.5/5|Day 29|
1695705|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|-0.076|Standard Error of the Mean|0.117|||2-Sided|95.0|-0.306|0.154|||||Difference calculated as T+O 5/5 minus T+O 1.25/5|Day 29|
1695706|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|0.102|Standard Error of the Mean|0.115|||2-Sided|95.0|-0.124|0.328|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Day 29|
1695707|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|0.084|Standard Error of the Mean|0.118|||2-Sided|95.0|-0.148|0.316|||||Difference calculated as T+O 5/5 minus Olo 5|Day 29|
1695708|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|0.262|Standard Error of the Mean|0.116|||2-Sided|95.0|0.034|0.491|||||Difference calculated as T+O 2.5/5 minus Olo 5|Day 29|
1695709|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.116|||2-Sided|95.0|-0.067|0.387|||||Difference calculated as T+O 1.25/ minus Olo 5|Day 29|
1695710|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|0.057|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.18|0.293|||||Difference calculated as T+O 5/10 minus T+O 2.5/10|Day 1|
1695711|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|0.226|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.01|0.461|||||Difference calculated as T+O 5/10 minus T+O 1.25/10|Day 1|
1695712|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.121|||2-Sided|95.0|-0.069|0.408|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Day 1|
1695713|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|-0.056|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.293|0.18|||||Difference calculated as T+O 5/10 minus Olo 10|Day 1|
1695719|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|-0.039|Standard Error of the Mean|0.122|||2-Sided|95.0|-0.278|0.199|||||Difference calculated as T+O 5/5 minus Olo 5|Day 1|
1695720|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|-0.133|Standard Error of the Mean|0.121|||2-Sided|95.0|-0.37|0.104|||||Difference calculated as T+O 2.5/5 minus Olo 5|Day 1|
1695721|NCT01040403|3118178|Superiority or Other||Mean Difference (Final Values)|0.014|Standard Error of the Mean|0.121|||2-Sided|95.0|-0.223|0.25|||||Difference calculated as T+O 1.25/5 minus Olo 5|Day 1|
1695722|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|0.117|Standard Error of the Mean|0.18|||2-Sided|95.0|-0.235|0.47|||||Difference calculated as T+O 5/10 minus T+O 2.5/10|Week 4|
1695723|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.029|Standard Error of the Mean|0.178|||2-Sided|95.0|-0.379|0.321|||||Difference calculated as T+O 5/10 minus T+O 1.25/10|Week 4|
1695724|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.146|Standard Error of the Mean|0.182|||2-Sided|95.0|-0.503|0.21|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Week 4|
1695725|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.246|Standard Error of the Mean|0.179|||2-Sided|95.0|-0.598|0.106|||||Difference calculated as T+O 5/10 minus Olo 10|Week 4|
1695726|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.363|Standard Error of the Mean|0.179|||2-Sided|95.0|-0.714|-0.012|||||Difference calculated as T+O 2.5/10 minus Olo 10|Week 4|
1695727|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.217|Standard Error of the Mean|0.179|||2-Sided|95.0|-0.568|0.135|||||Difference calculated as T+O 1.25/10 minus Olo 10|Week 4|
1695728|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|0.144|Standard Error of the Mean|0.179|||2-Sided|95.0|-0.208|0.496|||||Difference calculated as T+O 5/5 minus T+O 2.5/5|Week 4|
1695729|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.058|Standard Error of the Mean|0.18|||2-Sided|95.0|-0.411|0.296|||||Difference calculated as T+O 5/5 minus T+O 1.25/5|Week 4|
1695730|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.202|Standard Error of the Mean|0.179|||2-Sided|95.0|-0.555|0.15|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Week 4|
1695731|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|0.052|Standard Error of the Mean|0.18|||2-Sided|95.0|-0.301|0.406|||||Difference calculated as T+O 5/5 minus Olo 5|Week 4|
1695732|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.092|Standard Error of the Mean|0.18|||2-Sided|95.0|-0.445|0.261|||||Difference calculated as T+O 2.5/5 minus Olo 5|Week 4|
1695733|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.179|||2-Sided|95.0|-0.241|0.462|||||Difference calculated as T+O 1.25/5 minus Olo 5|Week 4|
1695734|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|0.073|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.242|0.388|||||Difference calculated as T+O 5/10 minus T+O 2.5/10|Week 1|
1695735|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.221|Standard Error of the Mean|0.159|||2-Sided|95.0|-0.533|0.092|||||Difference calculated as T+O 5/10 minus T+O 1.25/10|Week 1|
1695736|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.293|Standard Error of the Mean|0.162|||2-Sided|95.0|-0.611|0.024|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|Week 1|
1695737|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.178|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.492|0.135|||||Difference calculated as T+O 5/10 minus Olo 10|Week 1|
1695738|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.251|Standard Error of the Mean|0.159|||2-Sided|95.0|-0.564|0.062|||||Difference calculated as T+O 2.5/10 minus Olo 10|Week 1|
1695739|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|0.042|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.271|0.355|||||Difference calculated as T+O 1.25/10 minus Olo 10|Week 1|
1695740|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|0.255|Standard Error of the Mean|0.161|||2-Sided|95.0|-0.062|0.571|||||Difference calculated as T+O 5/5 minus T+O 2.5/5|Week 1|
1695741|NCT01040403|3118179|Superiority or Other||Mean Difference (Net)|0.147|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.168|0.462|||||Difference calculated as T+O 5/5 minus T+O 1.25/5|Week 1|
1695742|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.107|Standard Error of the Mean|0.159|||2-Sided|95.0|-0.42|0.206|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|Week 1|
1695743|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.065|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.379|0.249|||||Difference calculated as T+O 5/5 minus Olo 5|Week 1|
1695744|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.319|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.634|-0.004|||||Difference calculated as T+O 2.5/5 minus Olo 5|Week 1|
1695745|NCT01040403|3118179|Superiority or Other||Mean Difference (Final Values)|-0.212|Standard Error of the Mean|0.158|||2-Sided|95.0|-0.523|0.099|||||Difference calculated as T+O 1.25/5 minus Olo 5|Week 1|
1695746|NCT01040403|3118183|Superiority or Other||Mean Difference (Final Values)|2.517|Standard Error of the Mean|4.87|||2-Sided|95.0|-7.046|12.079|||||Difference calculated as T+O 5/10 minus T+O 2.5/10||
1695747|NCT01040403|3118183|Superiority or Other||Mean Difference (Final Values)|4.446|Standard Error of the Mean|4.854|||2-Sided|95.0|-5.085|13.978|||||Difference calculated as T+O 5/10 minus T+O 1.25/10||
1695748|NCT01040403|3118183|Superiority or Other||Mean Difference (Final Values)|1.93|Standard Error of the Mean|4.909|||2-Sided|95.0|-7.708|11.568|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10||
1695749|NCT01040403|3118183|Superiority or Other||Mean Difference (Final Values)|7.432|Standard Error of the Mean|4.882|||2-Sided|95.0|-2.154|17.019|||||Difference calculated as T+O 5/10 minus Olo 10||
1695750|NCT01040403|3118183|Superiority or Other||Mean Difference (Final Values)|4.916|Standard Error of the Mean|4.868|||2-Sided|95.0|-4.643|14.475|||||Difference calculated as T+O 2.5/10 minus Olo 10||
1695751|NCT01040403|3118183|Superiority or Other||Mean Difference (Final Values)|2.986|Standard Error of the Mean|4.876|||2-Sided|95.0|-6.589|12.561|||||Difference calculated as T+O 1.25/10 minus Olo 10||
1695752|NCT01040403|3118183|Superiority or Other||Mean Difference (Final Values)|0.753|Standard Error of the Mean|4.873|||2-Sided|95.0|-8.816|10.322|||||Difference calculated as T+O 5/5 minus T+O 2.5/5||
1696167|NCT01036022|3118548|Superiority or Other||Ratio|0.41|||||2-Sided|95.0|0.11|1.48||||||Placebo versus GSK1399686 100 mg for Week 6 fecal lactoferrin levels|
1695753|NCT01040403|3118183|Superiority or Other||Mean Difference (Final Values)|4.02|Standard Error of the Mean|4.904|||2-Sided|95.0|-5.61|13.65|||||Difference calculated as T+O 5/5 minus T+O 1.25/5||
1695754|NCT01040403|3118183|Superiority or Other||Mean Difference (Final Values)|3.267|Standard Error of the Mean|4.828|||2-Sided|95.0|-6.214|12.747|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5||
1695755|NCT01040403|3118183|Superiority or Other||Mean Difference (Final Values)|5.189|Standard Error of the Mean|4.887|||2-Sided|95.0|-4.407|14.785|||||Difference calculated as T+O 5/5 minus Olo 5||
1695756|NCT01040403|3118183|Superiority or Other||Mean Difference (Final Values)|4.436|Standard Error of the Mean|4.843|||2-Sided|95.0|-5.073|13.945|||||Difference calculated as T+O 2.5/5 minus Olo 5||
1695757|NCT01040403|3118183|Superiority or Other||Mean Difference (Final Values)|1.17|Standard Error of the Mean|4.853|||2-Sided|95.0|-8.36|10.699|||||Difference calculated as T+O 1.25/5 minus Olo 5||
1695758|NCT01040403|3118184|Superiority or Other||Mean Difference (Final Values)|0.98|Standard Error of the Mean|4.861|||2-Sided|95.0|-8.566|10.525|||||Difference calculated as T+O 5/10 minus T+O 2.5/10||
1695759|NCT01040403|3118184|Superiority or Other||Mean Difference (Final Values)|7.353|Standard Error of the Mean|4.845|||2-Sided|95.0|-2.161|16.866|||||Difference calculated as T+O 5/10 minus T+O 1.25/10||
1695760|NCT01040403|3118184|Superiority or Other||Mean Difference (Final Values)|6.373|Standard Error of the Mean|4.896|||2-Sided|95.0|-3.24|15.986|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10||
1695761|NCT01040403|3118184|Superiority or Other||Mean Difference (Final Values)|25.095|Standard Error of the Mean|4.876|||2-Sided|95.0|15.52|34.67|||||Difference calculated as T+O 5/10 minus Olo 10||
1695762|NCT01040403|3118184|Superiority or Other||Mean Difference (Final Values)|24.115|Standard Error of the Mean|4.856|||2-Sided|95.0|14.58|33.651|||||Difference calculated as T+O 2.5/10 minus Olo 10||
1695763|NCT01040403|3118184|Superiority or Other||Mean Difference (Final Values)|17.742|Standard Error of the Mean|4.862|||2-Sided|95.0|8.194|27.29|||||Difference calculated as T+O 1.25/10 minus Olo 10||
1695764|NCT01040403|3118184|Superiority or Other||Mean Difference (Final Values)|6.498|Standard Error of the Mean|4.866|||2-Sided|95.0|-3.057|16.053|||||Difference calculated as T+O 5/5 minus T+O 2.5/5||
1695765|NCT01040403|3118184|Superiority or Other||Mean Difference (Final Values)|11.415|Standard Error of the Mean|4.907|||2-Sided|95.0|1.78|21.05|||||Difference calculated as T+O 5/5 minus T+O 1.25/5||
1695766|NCT01040403|3118184|Superiority or Other||Mean Difference (Final Values)|4.917|Standard Error of the Mean|4.83|||2-Sided|95.0|-4.568|14.402|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5||
1695767|NCT01040403|3118184|Superiority or Other||Mean Difference (Final Values)|30.097|Standard Error of the Mean|4.879|||2-Sided|95.0|20.517|39.677|||||Difference calculated as T+O 5/5 minus Olo 5||
1695768|NCT01040403|3118184|Superiority or Other||Mean Difference (Final Values)|23.599|Standard Error of the Mean|4.83|||2-Sided|95.0|14.116|33.083|||||Difference calculated as T+O 2.5/5 minus Olo 5||
1695769|NCT01040403|3118184|Superiority or Other||Mean Difference (Final Values)|18.682|Standard Error of the Mean|4.849|||2-Sided|95.0|9.161|28.204|||||Difference calculated as T+O 1.25/5 minus Olo 5||
1695770|NCT01040403|3118185|Superiority or Other||Mean Difference (Final Values)|3.859|Standard Error of the Mean|4.403|||2-Sided|95.0|-4.786|12.504|||||Difference calculated as T+O 5/10 minus T+O 2.5/10||
1695771|NCT01040403|3118185|Superiority or Other||Mean Difference (Final Values)|5.663|Standard Error of the Mean|4.381|||2-Sided|95.0|-2.97|14.236|||||Difference calculated as T+O 5/10 minus T+O 1.25/10||
1695772|NCT01040403|3118185|Superiority or Other||Mean Difference (Final Values)|1.774|Standard Error of the Mean|4.423|||2-Sided|95.0|-6.91|10.458|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10||
1695773|NCT01040403|3118185|Superiority or Other||Mean Difference (Final Values)|7.121|Standard Error of the Mean|4.408|||2-Sided|95.0|-1.535|15.778|||||Difference calculated as T+O 5/10 minus Olo 10||
1695774|NCT01040403|3118185|Superiority or Other||Mean Difference (Final Values)|3.262|Standard Error of the Mean|4.386|||2-Sided|95.0|-5.35|11.875|||||Difference calculated as T+O 2.5/10 minus Olo 10||
1695775|NCT01040403|3118185|Superiority or Other||Mean Difference (Final Values)|1.488|Standard Error of the Mean|4.392|||2-Sided|95.0|-7.136|10.113|||||Difference calculated as T+O 1.25/10 minus Olo 10||
1695776|NCT01040403|3118185|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|4.39|||2-Sided|95.0|-8.43|8.81|||||Difference calculated as T+O 5/5 minus T+O 2.5/5||
1695777|NCT01040403|3118185|Superiority or Other||Mean Difference (Final Values)|2.352|Standard Error of the Mean|4.419|||2-Sided|95.0|-6.326|11.029|||||Difference calculated as T+O 5/5 minus T+O 1.25/5||
1695778|NCT01040403|3118185|Superiority or Other||Mean Difference (Final Values)|2.162|Standard Error of the Mean|4.349|||2-Sided|95.0|-6.379|10.702|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5||
1695779|NCT01040403|3118185|Superiority or Other||Mean Difference (Final Values)|4.668|Standard Error of the Mean|4.403|||2-Sided|95.0|-3.978|13.314|||||Difference calculated as T+O 5/5 minus Olo 5||
1695780|NCT01040403|3118185|Superiority or Other||Mean Difference (Final Values)|4.478|Standard Error of the Mean|4.362|||2-Sided|95.0|-4.088|13.044|||||Difference calculated as T+O 2.5/5 minus Olo 5||
1695781|NCT01040403|3118185|Superiority or Other||Mean Difference (Final Values)|2.316|Standard Error of the Mean|4.371|||2-Sided|95.0|-6.268|10.9|||||Difference calculated as T+O 1.25/5 minus Olo 5||
1695782|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|2.773|Standard Error of the Mean|4.024|||2-Sided|95.0|-5.129|10.675|||||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h|
1695783|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|5.881|Standard Error of the Mean|4.009|||2-Sided|95.0|-1.991|13.754|||||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h|
1695784|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|3.108|Standard Error of the Mean|4.053|||2-Sided|95.0|-4.852|11.067|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h|
1695785|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|25.536|Standard Error of the Mean|4.038|||2-Sided|95.0|17.607|33.464|||||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h|
1695786|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|22.762|Standard Error of the Mean|4.021|||2-Sided|95.0|14.866|30.659|||||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h|
1695787|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|19.654|Standard Error of the Mean|4.025|||2-Sided|95.0|11.75|27.558|||||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h|
1695788|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|3.337|Standard Error of the Mean|4.028|||2-Sided|95.0|-4.572|11.247|||||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h|
1695789|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|10.596|Standard Error of the Mean|4.061|||2-Sided|95.0|2.621|18.571|||||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h|
1695790|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|7.259|Standard Error of the Mean|3.998|||2-Sided|95.0|-0.592|15.109|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h|
1695791|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|29.347|Standard Error of the Mean|4.039|||2-Sided|95.0|21.416|37.278|||||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h|
1695792|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|26.009|Standard Error of the Mean|3.998|||2-Sided|95.0|18.158|33.86|||||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h|
1695793|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|18.751|Standard Error of the Mean|4.013|||2-Sided|95.0|10.87|26.632|||||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h|
1695794|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|-0.694|Standard Error of the Mean|4.2|||2-Sided|95.0|-8.941|7.554|||||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h|
1695795|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|4.499|Standard Error of the Mean|4.185|||2-Sided|95.0|-3.719|12.717|||||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h|
1695796|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|5.193|Standard Error of the Mean|4.23|||2-Sided|95.0|-3.115|13.5|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h|
1695797|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|22.817|Standard Error of the Mean|4.214|||2-Sided|95.0|14.543|31.092|||||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h|
1695798|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|23.511|Standard Error of the Mean|4.197|||2-Sided|95.0|15.27|31.752|||||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h|
1695799|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|18.318|Standard Error of the Mean|4.201|||2-Sided|95.0|10.068|26.568|||||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h|
1695800|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|4.648|Standard Error of the Mean|4.204|||2-Sided|95.0|-3.608|12.903|||||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h|
1695801|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|11.046|Standard Error of the Mean|4.239|||2-Sided|95.0|2.721|19.37|||||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h|
1695802|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|6.398|Standard Error of the Mean|4.173|||2-Sided|95.0|-1.796|14.592|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h|
1695803|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|29.804|Standard Error of the Mean|4.216|||2-Sided|95.0|21.526|38.082|||||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h|
1695804|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|25.157|Standard Error of the Mean|4.173|||2-Sided|95.0|16.962|33.351|||||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h|
1695805|NCT01040403|3118186|Superiority or Other||Mean Difference (Final Values)|18.759|Standard Error of the Mean|4.189|||2-Sided|95.0|10.533|26.985|||||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h|
1695806|NCT01040403|3118187|Superiority or Other||Mean Difference (Final Values)|-0.012|Standard Error of the Mean|0.032|||2-Sided|95.0|-0.075|0.052|||||Difference calculated as T+O 5/10 minus T+O 2.5/10||
1695807|NCT01040403|3118187|Superiority or Other||Mean Difference (Final Values)|-0.042|Standard Error of the Mean|0.032|||2-Sided|95.0|-0.105|0.021|||||Difference calculated as T+O 5/10 minus T+O 1.25/10||
1695808|NCT01040403|3118187|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.033|||2-Sided|95.0|-0.094|0.034|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10||
1695809|NCT01040403|3118187|Superiority or Other||Mean Difference (Final Values)|0.069|Standard Error of the Mean|0.032|||2-Sided|95.0|0.005|0.132|||||Difference calculated as T+O 5/10 minus Olo 10||
1695810|NCT01040403|3118187|Superiority or Other||Mean Difference (Final Values)|0.081|Standard Error of the Mean|0.032|||2-Sided|95.0|0.017|0.144|||||Difference calculated as T+O 2.5/10 minus Olo 10||
1695811|NCT01040403|3118187|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|0.032|||2-Sided|95.0|0.047|0.174|||||Difference calculated as T+O 1.25/10 minus Olo 10||
1695812|NCT01040403|3118187|Superiority or Other||Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.032|||2-Sided|95.0|-0.082|0.045|||||Difference calculated as T+O 5/5 minus +O 2.5/5||
1695813|NCT01040403|3118187|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.033|||2-Sided|95.0|-0.024|0.104|||||Difference calculated as T+O 5/5 minus T+O 1.25/5||
1695814|NCT01040403|3118187|Superiority or Other||Mean Difference (Final Values)|0.059|Standard Error of the Mean|0.032|||2-Sided|95.0|-0.004|0.122|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5||
1695815|NCT01040403|3118187|Superiority or Other||Mean Difference (Final Values)|-0.011|Standard Error of the Mean|0.032|||2-Sided|95.0|-0.074|0.053|||||Difference calculated as T+O 5/5 minus Olo 5||
1695816|NCT01040403|3118187|Superiority or Other||Mean Difference (Final Values)|0.008|Standard Error of the Mean|0.032|||2-Sided|95.0|-0.055|0.071|||||Difference calculated as T+O 2.5/5 minus Olo 5||
1695817|NCT01040403|3118187|Superiority or Other||Mean Difference (Final Values)|-0.051|Standard Error of the Mean|0.032|||2-Sided|95.0|-0.114|0.013|||||Difference calculated as T+O 1.25/5 minus Olo 5||
1695818|NCT01040403|3118188|Superiority or Other||Mean Difference (Final Values)|0.022|Standard Error of the Mean|0.035|||2-Sided|95.0|-0.046|0.09|||||Difference calculated as T+O 5/10 minus T+O 2.5/10||
1695819|NCT01040403|3118188|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.035|||2-Sided|95.0|-0.038|0.098|||||Difference calculated as T+O 5/10 minus T+O 1.25/10||
1695820|NCT01040403|3118188|Superiority or Other||Mean Difference (Final Values)|0.008|Standard Error of the Mean|0.035|||2-Sided|95.0|-0.061|0.076|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10||
1695821|NCT01040403|3118188|Superiority or Other||Mean Difference (Final Values)|0.204|Standard Error of the Mean|0.035|||2-Sided|95.0|0.135|0.272|||||Difference calculated as T+O 5/10 minus Olo 10||
1695822|NCT01040403|3118188|Superiority or Other||Mean Difference (Final Values)|0.182|Standard Error of the Mean|0.035|||2-Sided|95.0|0.113|0.25|||||Difference calculated as T+O 2.5/10 minus Olo 10||
1695823|NCT01040403|3118188|Superiority or Other||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.035|||2-Sided|95.0|0.106|0.242|||||Difference calculated as T+O 1.25/10 minus Olo 10||
1695824|NCT01040403|3118188|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.035|||2-Sided|95.0|-0.089|0.048|||||Difference calculated as T+O 5/5 minus T+O 2.5/5||
1695825|NCT01040403|3118188|Superiority or Other||Mean Difference (Final Values)|-0.028|Standard Error of the Mean|0.035|||2-Sided|95.0|-0.097|0.041|||||Difference calculated as T+O 5/5 minus T+O 1.25/5||
1695826|NCT01040403|3118188|Superiority or Other||Mean Difference (Final Values)|-0.008|Standard Error of the Mean|0.035|||2-Sided|95.0|-0.075|0.06|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5||
1695827|NCT01040403|3118188|Superiority or Other||Mean Difference (Final Values)|0.127|Standard Error of the Mean|0.035|||2-Sided|95.0|0.058|0.195|||||Difference calculated as T+O 5/5 minus Olo 5||
1695828|NCT01040403|3118188|Superiority or Other||Mean Difference (Final Values)|0.147|Standard Error of the Mean|0.035|||2-Sided|95.0|0.079|0.215|||||Difference calculated as T+O 2.5/5 minus Olo 5||
1695829|NCT01040403|3118188|Superiority or Other||Mean Difference (Final Values)|0.155|Standard Error of the Mean|0.035|||2-Sided|95.0|0.087|0.223|||||Difference calculated as T+O 1.25/5 minus Olo 5||
1695830|NCT01040403|3118189|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.062|0.055|||||Difference calculated as T+O 5/10 minus T+O 2.5/10||
1695831|NCT01040403|3118189|Superiority or Other||Mean Difference (Final Values)|-0.034|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.092|0.024|||||Difference calculated as T+O 5/10 minus T+O 1.25/10||
1695832|NCT01040403|3118189|Superiority or Other||Mean Difference (Final Values)|-0.031|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.089|0.028|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10||
1695833|NCT01040403|3118189|Superiority or Other||Mean Difference (Final Values)|0.056|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.002|0.114|||||Difference calculated as T+O 5/10 minus Olo 10||
1695834|NCT01040403|3118189|Superiority or Other||Mean Difference (Final Values)|0.059|Standard Error of the Mean|0.03|||2-Sided|95.0|0.001|0.118|||||Difference calculated as T+O 2.5/10 minus Olo 10||
1695835|NCT01040403|3118189|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.03|||2-Sided|95.0|0.032|0.148|||||Difference calculated as T+O 1.25/10 minus Olo 10||
1695836|NCT01040403|3118189|Superiority or Other||Mean Difference (Final Values)|-0.007|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.065|0.051|||||Difference calculated as T+O 5/5 minus T+O 2.5/5||
1695837|NCT01040403|3118189|Superiority or Other||Mean Difference (Final Values)|0.034|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.024|0.093|||||Difference calculated as T+O 5/5 minus T+O 1.25/5||
1695838|NCT01040403|3118189|Superiority or Other||Mean Difference (Final Values)|0.041|Standard Error of the Mean|0.029|||2-Sided|95.0|-0.017|0.099|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5||
1695839|NCT01040403|3118189|Superiority or Other||Mean Difference (Final Values)|-0.014|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.072|0.044|||||Difference calculated as T+O 5/5 minus Olo 5||
1695840|NCT01040403|3118189|Superiority or Other||Mean Difference (Final Values)|-0.007|Standard Error of the Mean|0.029|||2-Sided|95.0|-0.065|0.051|||||Difference calculated as T+O 2.5/5 minus Olo 5||
1695841|NCT01040403|3118189|Superiority or Other||Mean Difference (Final Values)|-0.048|Standard Error of the Mean|0.029|||2-Sided|95.0|-0.106|0.01|||||Difference calculated as T+O 1.25/5 minus Olo 5||
1695842|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.035|Standard Error of the Mean|0.029|||2-Sided|95.0|-0.023|0.092|||||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h|
1695843|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.029|||2-Sided|95.0|-0.033|0.082|||||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h|
1695844|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.069|0.048|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h|
1695845|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.213|Standard Error of the Mean|0.029|||2-Sided|95.0|0.155|0.271|||||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h|
1695846|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.179|Standard Error of the Mean|0.029|||2-Sided|95.0|0.121|0.236|||||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h|
1695847|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.189|Standard Error of the Mean|0.029|||2-Sided|95.0|0.131|0.247|||||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h|
1695848|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|-0.018|Standard Error of the Mean|0.029|||2-Sided|95.0|-0.076|0.039|||||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h|
1695849|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|-0.008|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.066|0.051|||||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h|
1695850|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.011|Standard Error of the Mean|0.029|||2-Sided|95.0|-0.047|0.068|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h|
1695851|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.029|||2-Sided|95.0|0.073|0.189|||||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h|
1695852|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.029|||2-Sided|95.0|0.092|0.207|||||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h|
1695853|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.139|Standard Error of the Mean|0.029|||2-Sided|95.0|0.081|0.197|||||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h|
1695854|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.035|0.083|||||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h|
1695855|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.035|0.083|||||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h|
1695856|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.06|0.059|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h|
1695857|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.03|||2-Sided|95.0|0.14|0.259|||||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h|
1695858|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.175|Standard Error of the Mean|0.03|||2-Sided|95.0|0.116|0.234|||||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h|
1695859|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.175|Standard Error of the Mean|0.03|||2-Sided|95.0|0.116|0.234|||||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h|
1695860|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.079|0.039|||||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h|
1695861|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|-0.012|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.071|0.048|||||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h|
1695862|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.008|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.051|0.066|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h|
1695863|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.03|||2-Sided|95.0|0.072|0.191|||||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h|
1695864|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.151|Standard Error of the Mean|0.03|||2-Sided|95.0|0.092|0.21|||||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h|
1695865|NCT01040403|3118190|Superiority or Other||Mean Difference (Final Values)|0.143|Standard Error of the Mean|0.03|||2-Sided|95.0|0.084|0.202|||||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h|
1695866|NCT01040403|3118191|Superiority or Other||Mean Difference (Final Values)|0.002|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.037|0.042|||||Difference calculated as T+O 5/10 minus T+O 2.5/10||
1695867|NCT01040403|3118191|Superiority or Other||Mean Difference (Final Values)|-0.007|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.046|0.033|||||Difference calculated as T+O 5/10 minus T+O 1.25/10||
1695868|NCT01040403|3118191|Superiority or Other||Mean Difference (Final Values)|-0.009|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.049|0.031|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10||
1695869|NCT01040403|3118191|Superiority or Other||Mean Difference (Final Values)|0.047|Standard Error of the Mean|0.02|||2-Sided|95.0|0.008|0.087|||||Difference calculated as T+O 5/10 minus Olo 10||
1695870|NCT01040403|3118191|Superiority or Other||Mean Difference (Final Values)|0.045|Standard Error of the Mean|0.02|||2-Sided|95.0|0.006|0.084|||||Difference calculated as T+O 2.5/10 minus Olo 10||
1695871|NCT01040403|3118191|Superiority or Other||Mean Difference (Final Values)|0.054|Standard Error of the Mean|0.02|||2-Sided|95.0|0.015|0.093|||||Difference calculated as T+O 1.25/10 minus Olo 10||
1695872|NCT01040403|3118191|Superiority or Other||Mean Difference (Final Values)|-0.002|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.041|0.037|||||Difference calculated as T+O 5/5 minus T+O 2.5/5||
1695873|NCT01040403|3118191|Superiority or Other||Mean Difference (Final Values)|0.031|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.009|0.071|||||Difference calculated as T+O 5/5 minus T+O 1.25/5||
1695874|NCT01040403|3118191|Superiority or Other||Mean Difference (Final Values)|0.033|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.006|0.072|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5||
1695875|NCT01040403|3118191|Superiority or Other||Mean Difference (Final Values)|0.012|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.028|0.051|||||Difference calculated as T+O 5/5 minus Olo 5||
1695876|NCT01040403|3118191|Superiority or Other||Mean Difference (Final Values)|0.014|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.026|0.053|||||Difference calculated as T+O 2.5/5 minus Olo 5||
1695877|NCT01040403|3118191|Superiority or Other||Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.059|0.02|||||Difference calculated as T+O 1.25/5 minus Olo 5||
1695878|NCT01040403|3118192|Superiority or Other||Mean Difference (Final Values)|0.013|Standard Error of the Mean|0.025|||2-Sided|95.0|-0.036|0.061|||||Difference calculated as T+O 5/10 minus T+O 2.5/10||
1695879|NCT01040403|3118192|Superiority or Other||Mean Difference (Final Values)|0.038|Standard Error of the Mean|0.025|||2-Sided|95.0|-0.01|0.086|||||Difference calculated as T+O 5/10 minus T+O 1.25/10||
1695880|NCT01040403|3118192|Superiority or Other||Mean Difference (Final Values)|0.025|Standard Error of the Mean|0.025|||2-Sided|95.0|-0.024|0.074|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10||
1695881|NCT01040403|3118192|Superiority or Other||Mean Difference (Final Values)|0.145|Standard Error of the Mean|0.025|||2-Sided|95.0|0.096|0.193|||||Difference calculated as T+O 5/10 minus Olo 10||
1695882|NCT01040403|3118192|Superiority or Other||Mean Difference (Final Values)|0.132|Standard Error of the Mean|0.025|||2-Sided|95.0|0.084|0.181|||||Difference calculated as T+O 2.5/10 minus Olo 10||
1695883|NCT01040403|3118192|Superiority or Other||Mean Difference (Final Values)|0.107|Standard Error of the Mean|0.025|||2-Sided|95.0|0.059|0.156|||||Difference calculated as T+O 1.25/10 minus Olo 10||
1695884|NCT01040403|3118192|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.025|||2-Sided|95.0|-0.025|0.072|||||Difference calculated as T+O 5/5 minus T+O 2.5/5||
1695885|NCT01040403|3118192|Superiority or Other||Mean Difference (Final Values)|0.026|Standard Error of the Mean|0.025|||2-Sided|95.0|-0.023|0.074|||||Difference calculated as T+O 5/5 minus T+O 1.25/5||
1695886|NCT01040403|3118192|Superiority or Other||Mean Difference (Final Values)|0.002|Standard Error of the Mean|0.025|||2-Sided|95.0|-0.046|0.05|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5||
1695887|NCT01040403|3118192|Superiority or Other||Mean Difference (Final Values)|0.115|Standard Error of the Mean|0.025|||2-Sided|95.0|0.066|0.164|||||Difference calculated as T+O 5/5 minus Olo 5||
1695888|NCT01040403|3118192|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.024|||2-Sided|95.0|0.043|0.139|||||Difference calculated as T+O 2.5/5 minus Olo 5||
1695889|NCT01040403|3118192|Superiority or Other||Mean Difference (Final Values)|0.089|Standard Error of the Mean|0.025|||2-Sided|95.0|0.041|0.138|||||Difference calculated as T+O 1.25/5 minus Olo 5||
1695890|NCT01040403|3118193|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.018|||2-Sided|95.0|-0.025|0.045|||||Difference calculated as T+O 5/10 minus T+O 2.5/10||
1695891|NCT01040403|3118193|Superiority or Other||Mean Difference (Final Values)|0.003|Standard Error of the Mean|0.018|||2-Sided|95.0|-0.032|0.037|||||Difference calculated as T+O 5/10 minus T+O 1.25/10||
1695892|NCT01040403|3118193|Superiority or Other||Mean Difference (Final Values)|-0.008|Standard Error of the Mean|0.018|||2-Sided|95.0|-0.043|0.027|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10||
1695893|NCT01040403|3118193|Superiority or Other||Mean Difference (Final Values)|0.041|Standard Error of the Mean|0.018|||2-Sided|95.0|0.006|0.076|||||Difference calculated as T+O 5/10 minus Olo 10||
1695894|NCT01040403|3118193|Superiority or Other||Mean Difference (Final Values)|0.031|Standard Error of the Mean|0.018|||2-Sided|95.0|-0.004|0.066|||||Difference calculated as T+O 2.5/10 minus Olo 10||
1695895|NCT01040403|3118193|Superiority or Other||Mean Difference (Final Values)|0.039|Standard Error of the Mean|0.018|||2-Sided|95.0|0.004|0.073|||||Difference calculated as T+O 1.25/10 minus Olo 10||
1695896|NCT01040403|3118193|Superiority or Other||Mean Difference (Final Values)|-0.004|Standard Error of the Mean|0.018|||2-Sided|95.0|-0.039|0.031|||||Difference calculated as T+O 5/5 minus T+O 2.5/5||
1695897|NCT01040403|3118193|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.018|||2-Sided|95.0|-0.011|0.059|||||Difference calculated as T+O 5/5 minus T+O 1.25/5||
1695898|NCT01040403|3118193|Superiority or Other||Mean Difference (Final Values)|0.028|Standard Error of the Mean|0.018|||2-Sided|95.0|-0.006|0.063|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5||
1695899|NCT01040403|3118193|Superiority or Other||Mean Difference (Final Values)|0.001|Standard Error of the Mean|0.018|||2-Sided|95.0|-0.034|0.036|||||Difference calculated as T+O 5/5 minus Olo 5||
1695900|NCT01040403|3118193|Superiority or Other||Mean Difference (Final Values)|0.005|Standard Error of the Mean|0.018|||2-Sided|95.0|-0.029|0.04|||||Difference calculated as T+O 2.5/5 minus Olo 5||
1695901|NCT01040403|3118193|Superiority or Other||Mean Difference (Final Values)|-0.023|Standard Error of the Mean|0.018|||2-Sided|95.0|-0.058|0.012|||||Difference calculated as T+O 1.25/5 minus Olo 5||
1695902|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.023|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.016|0.061|||||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-6h|
1695903|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.046|Standard Error of the Mean|0.019|||2-Sided|95.0|0.007|0.084|||||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-6h|
1695904|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.023|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.016|0.062|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-6h|
1695905|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.144|Standard Error of the Mean|0.02|||2-Sided|95.0|0.105|0.182|||||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-6h|
1695906|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.121|Standard Error of the Mean|0.02|||2-Sided|95.0|0.083|0.159|||||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-6h|
1695907|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.098|Standard Error of the Mean|0.02|||2-Sided|95.0|0.06|0.136|||||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-6h|
1695908|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.019|0.058|||||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-6h|
1695909|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.02|||2-Sided|95.0|0.001|0.079|||||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-6h|
1695910|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.019|||2-Sided|95.0|-0.018|0.058|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-6h|
1695911|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.118|Standard Error of the Mean|0.02|||2-Sided|95.0|0.08|0.157|||||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-6h|
1695912|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.099|Standard Error of the Mean|0.019|||2-Sided|95.0|0.06|0.137|||||difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-6h|
1695913|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.078|Standard Error of the Mean|0.02|||2-Sided|95.0|0.04|0.117|||||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-6h|
1695914|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.015|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.025|0.055|||||Difference calculated as T+O 5/10 minus T+O 2.5/10|AUC 0-3h|
1695915|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.046|Standard Error of the Mean|0.02|||2-Sided|95.0|0.006|0.086|||||Difference calculated as T+O 5/10 minus T+O 1.25/10|AUC 0-3h|
1695916|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.031|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.009|0.071|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10|AUC 0-3h|
1695917|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.143|Standard Error of the Mean|0.02|||2-Sided|95.0|0.103|0.183|||||Difference calculated as T+O 5/10 minus Olo 10|AUC 0-3h|
1695918|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.128|Standard Error of the Mean|0.02|||2-Sided|95.0|0.088|0.168|||||Difference calculated as T+O 2.5/10 minus Olo 10|AUC 0-3h|
1695919|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.02|||2-Sided|95.0|0.057|0.137|||||Difference calculated as T+O 1.25/10 minus Olo 10|AUC 0-3h|
1695920|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.022|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.018|0.062|||||Difference calculated as T+O 5/5 minus T+O 2.5/5|AUC 0-3h|
1695921|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.045|Standard Error of the Mean|0.021|||2-Sided|95.0|0.004|0.085|||||Difference calculated as T+O 5/5 minus T+O 1.25/5|AUC 0-3h|
1695922|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.022|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.017|0.062|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5|AUC 0-3h|
1695923|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.119|Standard Error of the Mean|0.02|||2-Sided|95.0|0.079|0.159|||||Difference calculated as T+O 5/5 minus Olo 5|AUC 0-3h|
1695924|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.02|||2-Sided|95.0|0.057|0.137|||||Difference calculated as T+O 2.5/5 minus Olo 5|AUC 0-3h|
1696010|NCT01039376|3118354|Superiority||Hazard Ratio (HR)|1.832|||||2-Sided|95.0|1.434|2.339|||||HR estimated for B2 Microglobulin Group 2 with 3500 as cut off: >3500 ug/L/<=3500 ug/L||
1695925|NCT01040403|3118194|Superiority or Other||Mean Difference (Final Values)|0.075|Standard Error of the Mean|0.02|||2-Sided|95.0|0.035|0.114|||||Difference calculated as T+O 1.25/5 minus Olo 5|AUC 0-3h|
1695926|NCT01040403|3118195|Superiority or Other||Mean Difference (Final Values)|-0.004|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.064|0.055|||||Difference calculated as T+O 5/10 minus T+O 2.5/10||
1695927|NCT01040403|3118195|Superiority or Other||Mean Difference (Final Values)|-0.004|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.063|0.056|||||Difference calculated as T+O 5/10 minus T+O 1.25/10||
1695928|NCT01040403|3118195|Superiority or Other||Mean Difference (Final Values)|0.001|Standard Error of the Mean|0.031|||2-Sided|95.0|-0.059|0.061|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10||
1695929|NCT01040403|3118195|Superiority or Other||Mean Difference (Final Values)|0.127|Standard Error of the Mean|0.03|||2-Sided|95.0|0.067|0.187|||||Difference calculated as T+O 5/10 minus Olo 10||
1695930|NCT01040403|3118195|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.03|||2-Sided|95.0|0.072|0.191|||||Difference calculated as T+O 2.5/10 minus Olo 10||
1695931|NCT01040403|3118195|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.03|||2-Sided|95.0|0.071|0.19|||||Difference calculated as T+O 1.25/10 minus Olo 10||
1695932|NCT01040403|3118195|Superiority or Other||Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.079|0.04|||||Difference calculated as T+O 5/5 minus T+O 2.5/5||
1695933|NCT01040403|3118195|Superiority or Other||Mean Difference (Final Values)|0.001|Standard Error of the Mean|0.031|||2-Sided|95.0|-0.059|0.061|||||Difference calculated as T+O 5/5 minus T+O 1.25/5||
1695934|NCT01040403|3118195|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.039|0.079|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5||
1695935|NCT01040403|3118195|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.03|||2-Sided|95.0|0.041|0.16|||||Difference calculated as T+O 5/5 minus Olo 5||
1695936|NCT01040403|3118195|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.03|||2-Sided|95.0|0.061|0.179|||||Difference calculated as T+O 2.5/5 minus Olo 5||
1695937|NCT01040403|3118195|Superiority or Other||Mean Difference (Final Values)|0.099|Standard Error of the Mean|0.03|||2-Sided|95.0|0.04|0.159|||||Difference calculated as T+O 1.25/5 minus Olo 5||
1695938|NCT01040403|3118196|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.019|||2-Sided|95.0|-0.041|0.035|||||Difference calculated as T+O 5/10 minus T+O 2.5/10||
1695939|NCT01040403|3118196|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.019|||2-Sided|95.0|-0.009|0.068|||||Difference calculated as T+O 5/10 minus T+O 1.25/10||
1695940|NCT01040403|3118196|Superiority or Other||Mean Difference (Final Values)|0.033|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.006|0.071|||||Difference calculated as T+O 2.5/10 minus T+O 1.25/10||
1695941|NCT01040403|3118196|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.02|||2-Sided|95.0|0.042|0.119|||||Difference calculated as T+O 5/10 minus Olo 10||
1695942|NCT01040403|3118196|Superiority or Other||Mean Difference (Final Values)|0.083|Standard Error of the Mean|0.019|||2-Sided|95.0|0.045|0.122|||||Difference calculated as T+O 2.5/10 minus Olo 10||
1695943|NCT01040403|3118196|Superiority or Other||Mean Difference (Final Values)|0.051|Standard Error of the Mean|0.019|||2-Sided|95.0|0.013|0.089|||||Difference calculated as T+O 1.25/10 minus Olo 10||
1695944|NCT01040403|3118196|Superiority or Other||Mean Difference (Final Values)|0.019|Standard Error of the Mean|0.019|||2-Sided|95.0|-0.019|0.058|||||Difference calculated as T+O 5/5 minus T+O 2.5/5||
1695945|NCT01040403|3118196|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.02|||2-Sided|95.0|-0.008|0.069|||||Difference calculated as T+O 5/5 minus T+O 1.25/5||
1695946|NCT01040403|3118196|Superiority or Other||Mean Difference (Final Values)|0.011|Standard Error of the Mean|0.019|||2-Sided|95.0|-0.027|0.049|||||Difference calculated as T+O 2.5/5 minus T+O 1.25/5||
1695947|NCT01040403|3118196|Superiority or Other||Mean Difference (Final Values)|0.084|Standard Error of the Mean|0.02|||2-Sided|95.0|0.046|0.122|||||Difference calculated as T+O 5/5 minus Olo 5||
1695948|NCT01040403|3118196|Superiority or Other||Mean Difference (Final Values)|0.065|Standard Error of the Mean|0.019|||2-Sided|95.0|0.027|0.103|||||Difference calculated as T+O 2.5/5 minus Olo 5||
1695949|NCT01040403|3118196|Superiority or Other||Mean Difference (Final Values)|0.054|Standard Error of the Mean|0.019|||2-Sided|95.0|0.016|0.092|||||Difference calculated as T+O 1.25/5 minus Olo 5||
1695950|NCT01040351|3118198|Non-Inferiority or Equivalence|. The aggregate result of 6 studies reporting the pregnancy rate of patients with ultrasound visible hydrosalpinx revealed that clinical pregnancy rate among the patients with ultrasound-visible hydrosalpinges was 12.6%. We assumed that the aspiration of hydrosalpinx could restore clinical pregnancy rate to that expected for patients with tubal factor of infertility but without hydrosalpinges (about 36.5% in our hospital)|Odds Ratio (OR)|3.02||||0.023|2-Sided|95.0|1.13|8.0|||Chi-squared||||
1695951|NCT01040169|3118203|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1695952|NCT01040169|3118204|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1695953|NCT01040130|3118210|Superiority or Other||Mean Difference (Final Values)|0.618|Standard Error of the Mean|0.059|<|0.0001||95.0|0.502|0.734|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695954|NCT01040130|3118210|Superiority or Other||Mean Difference (Final Values)|0.585|Standard Error of the Mean|0.063|<|0.0001||95.0|0.47|0.701|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695955|NCT01040130|3118211|Superiority or Other||Mean Difference (Final Values)|0.303|Standard Error of the Mean|0.056|<|0.0001||95.0|0.192|0.414|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695956|NCT01040130|3118211|Superiority or Other||Mean Difference (Final Values)|0.318|Standard Error of the Mean|0.056|<|0.0001||95.0|0.207|0.429|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1696168|NCT01036022|3118548|Superiority or Other||Ratio|2.21|||||2-Sided|95.0|0.54|9.04||||||Placebo versus GSK1399686 30 mg for Week 6 fecal lactoferrin levels|
1695957|NCT01040130|3118212|Superiority or Other||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.029|<|0.0001||95.0|0.233|0.348|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695958|NCT01040130|3118212|Superiority or Other||Mean Difference (Final Values)|0.285|Standard Error of the Mean|0.029|<|0.0001||95.0|0.227|0.342|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695959|NCT01040130|3118213|Superiority or Other||Mean Difference (Final Values)|0.098|Standard Error of the Mean|0.031||0.0017||95.0|0.037|0.158|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695960|NCT01040130|3118213|Superiority or Other||Mean Difference (Final Values)|0.107|Standard Error of the Mean|0.031||0.0006||95.0|0.046|0.167|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695961|NCT01040130|3118214|Superiority or Other||Mean Difference (Final Values)|0.226|Standard Error of the Mean|0.017|<|0.0001||95.0|0.193|0.259|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695962|NCT01040130|3118214|Superiority or Other||Mean Difference (Final Values)|0.224|Standard Error of the Mean|0.017|<|0.0001||95.0|0.191|0.258|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695963|NCT01040130|3118215|Superiority or Other||Mean Difference (Final Values)|0.101|Standard Error of the Mean|0.017|<|0.0001||95.0|0.068|0.134|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695964|NCT01040130|3118215|Superiority or Other||Mean Difference (Final Values)|0.089|Standard Error of the Mean|0.017|<|0.0001||95.0|0.056|0.123|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695965|NCT01040130|3118216|Superiority or Other||Mean Difference (Final Values)|-0.159|Standard Error of the Mean|0.068||0.0202||95.0|-0.292|-0.025|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695966|NCT01040130|3118216|Superiority or Other||Mean Difference (Final Values)|-0.014|Standard Error of the Mean|0.067||0.8302||95.0|-0.146|0.118|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695967|NCT01040130|3118217|Superiority or Other||Mean Difference (Final Values)|-0.021|Standard Error of the Mean|0.062||0.7368||95.0|-0.144|0.102|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695968|NCT01040130|3118217|Superiority or Other||Mean Difference (Final Values)|0.006|Standard Error of the Mean|0.062||0.9239||95.0|-0.115|0.127|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695969|NCT01040130|3118218|Superiority or Other||Mean Difference (Final Values)|0.216|Standard Error of the Mean|0.036|<|0.0001||95.0|0.146|0.285|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695970|NCT01040130|3118218|Superiority or Other||Mean Difference (Final Values)|0.206|Standard Error of the Mean|0.035|<|0.0001||95.0|0.136|0.275|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695971|NCT01040130|3118219|Superiority or Other||Mean Difference (Final Values)|0.092|Standard Error of the Mean|0.034||0.0073||95.0|0.025|0.159|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695972|NCT01040130|3118219|Superiority or Other||Mean Difference (Final Values)|0.119|Standard Error of the Mean|0.034||0.0005||95.0|0.052|0.185|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695973|NCT01040130|3118220|Superiority or Other||Mean Difference (Final Values)|-0.373|Standard Error of the Mean|0.066|<|0.0001||95.0|-0.503|-0.243|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695974|NCT01040130|3118220|Superiority or Other||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.066|<|0.0015||95.0|-0.339|-0.081|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695975|NCT01040130|3118221|Superiority or Other||Mean Difference (Final Values)|-0.115|Standard Error of the Mean|0.07||0.1013||95.0|-0.252|0.023|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695976|NCT01040130|3118221|Superiority or Other||Mean Difference (Final Values)|-0.122|Standard Error of the Mean|0.069||0.0784||95.0|-0.258|0.014|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695977|NCT01040130|3118222|Superiority or Other||Mean Difference (Final Values)|0.256|Standard Error of the Mean|0.155||0.1003||95.0|-0.05|0.561|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695978|NCT01040130|3118222|Superiority or Other||Mean Difference (Final Values)|-0.088|Standard Error of the Mean|0.154||0.5698||95.0|-0.391|0.216|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695979|NCT01040130|3118223|Superiority or Other||Mean Difference (Final Values)|-0.064|Standard Error of the Mean|0.052||0.2132||95.0|-0.166|0.037|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695980|NCT01040130|3118223|Superiority or Other||Mean Difference (Final Values)|-0.103|Standard Error of the Mean|0.051||0.0447||95.0|-0.204|-0.002|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1696011|NCT01039376|3118354|Superiority||Hazard Ratio (HR)|4.219|||||2-Sided|95.0|2.468|7.21|||||HR estimated for Cytogenetics Group (based on >=20% cut-off) with 11q-/no abberation||
1695981|NCT01040130|3118224|Superiority or Other||Mean Difference (Final Values)|0.137|Standard Error of the Mean|0.037||0.0003||95.0|0.064|0.21|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695982|NCT01040130|3118224|Superiority or Other||Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.037|<|0.0001||95.0|0.107|0.252|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695983|NCT01040130|3118225|Superiority or Other||Mean Difference (Final Values)|0.294|Standard Error of the Mean|0.035|<|0.0001||95.0|0.226|0.362|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695984|NCT01040130|3118225|Superiority or Other||Mean Difference (Final Values)|0.258|Standard Error of the Mean|0.034|<|0.0001||95.0|0.191|0.325|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695985|NCT01040130|3118226|Superiority or Other||Mean Difference (Final Values)|-0.634|Standard Error of the Mean|0.225||0.0051||95.0|-1.077|-0.192|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695986|NCT01040130|3118226|Superiority or Other||Mean Difference (Final Values)|-0.766|Standard Error of the Mean|0.223||0.0007||95.0|-1.205|-0.326|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695987|NCT01040130|3118227|Superiority or Other||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.036|<|0.0001||95.0|0.104|0.245|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 10 mcg minus Placebo||
1695988|NCT01040130|3118227|Superiority or Other||Mean Difference (Final Values)|0.182|Standard Error of the Mean|0.036|<|0.0001||95.0|0.112|0.252|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline and period as fixed and patient as random effect.|Olo 5 mcg minus Placebo||
1695989|NCT01040130|3118228|Superiority or Other||Ratio to placebo|1.138|Standard Error of the Mean|0.04||0.0003||95.0|1.062|1.219|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 10 mcg divided by Placebo||
1695990|NCT01040130|3118228|Superiority or Other||Ratio to placebo|1.14|Standard Error of the Mean|0.04||0.0002||95.0|1.065|1.221|||Mixed Models Analysis|Mixed effects repeated measures with treatment, baseline endurance time and period as fixed and patient as random effect. Means, CI back-transformed.|Olo 5 mcg divided by Placebo||
1695991|NCT01039688|3118316|Superiority or Other||Risk Difference (RD)|25.25|||<|0.0001|2-Sided|95.0|18.51|31.99||A stepdown procedure was used to control for multiple comparisons. For comparison of 10 mg to MTX in ACR70 to be statistically significant, comparison of 10 mg to MTX in change from BL in mTSS had to be statistically significant|Normal approximation||||
1695992|NCT01039688|3118316|Superiority or Other||Risk Difference (RD)|13.32|||<|0.0001|2-Sided|95.0|6.81|19.82||A stepdown procedure was used to control for multiple comparisons. For comparison of 5 mg to be statistically significant, comparison of 10 mg to MTX in ACR70 and comparison of 5 mg to MTX in change from BL in mTSS had to be statistically significant|Normal approximation||||
1695993|NCT01039688|3118317|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.14||0.0004|2-Sided|95.0|-0.77|-0.23||A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.|ANCOVA||||
1695994|NCT01039688|3118317|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.14||0.0014|2-Sided|95.0|-0.73|-0.18||A stepdown procedure was used to control for multiple comparisons. In order for the comparison of CP-690,550 5 mg to be statistically significant versus MTX, the comparison of CP-690,550 10 mg versus MTX had to be statistically significant.|ANCOVA||||
1695995|NCT01039675|3118321|Non-Inferiority or Equivalence|UMEC/VI will be declared non-inferior to placebo in terms of weighted mean pulse rate if the upper limit of the 95% confidence interval around the estimated treatment difference for weighted mean pulse rate is less than the non-inferiority margin of +10bpm.|Mean Difference (Final Values)|-0.5|||||2-Sided|95.0|-5.5|4.5|||||Estimated from repeated measures analysis of covariance.||
1695996|NCT01039584|3118322|Non-Inferiority or Equivalence|The efficacy measure was the proportion of subjects with mycological cure at Visit 3/Test-of-Cure|Yates continuity correction|1.5||||0.05|2-Sided|90.0|-11.7|9.4|||Wald's method||||
1695997|NCT01039584|3118323|Non-Inferiority or Equivalence|The efficacy measure was the proportion of subjects with clinicl cure at Visit 3/Test-of-Cure.|Yates continuity correction|1.5|||||2-Sided|90.0|-7.3|12.8|||||||
1695998|NCT01039584|3118324|Non-Inferiority or Equivalence|The primary efficacy measure was the proportion of subjects with therapeutic cure at Visit 3/Test-of-Cure. Therapeutic cure was defined as having both a mycological cure and a clinical cure.|Yates continuity correction|1.5|||||2-Sided|90.0|-9.1|12.3|||||||
1695999|NCT01039467|3118331|Superiority or Other (legacy)|||||||0.493|||||||Wilcoxon (Mann-Whitney)||||
1696000|NCT01039467|3118332|Superiority or Other (legacy)|||||||0.053|||||||Wilcoxon (Mann-Whitney)||||
1696001|NCT01039467|3118333|Superiority or Other (legacy)|||||||0.0008|||||||Wilcoxon (Mann-Whitney)||||
1696002|NCT01039467|3118334|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1696003|NCT01039467|3118335|Superiority or Other (legacy)||||||<|0.0001|||||||Chi-squared||||
1696004|NCT01039467|3118336|Superiority or Other (legacy)|||||||0.265|||||||Wilcoxon (Mann-Whitney)||||
1696005|NCT01039467|3118337|Superiority or Other (legacy)|||||||0.833|||||||Wilcoxon (Mann-Whitney)||||
1696006|NCT01039467|3118338|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1696007|NCT01039467|3118339|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1696008|NCT01039376|3118354|Superiority||Hazard Ratio (HR)|1.301|||||2-Sided|95.0|0.692|2.448|||||HR estimated for VH3-21 Usage Flag Yes/No.||
1696009|NCT01039376|3118354|Superiority||Hazard Ratio (HR)|0.573|||||2-Sided|95.0|0.432|0.76|||||HR estimated for IgVH Mutational Status 1 Mutated/Unmutated||
1696407|NCT01033942|3118848|Superiority or Other|||||||0.7847|||||||Fisher Exact||||
1696012|NCT01039376|3118354|Superiority||Hazard Ratio (HR)|9.303|||||2-Sided|95.0|4.934|17.54|||||HR estimated for Cytogenetics Group (based on >=20% cut-off) with 17p-/no abberation||
1696013|NCT01039376|3118354|Superiority||Hazard Ratio (HR)|1.547|||||2-Sided|95.0|1.051|2.276|||||HR estimated for Cytogenetics Group (based on >=20% cut-off) with 6q-, or +12q or 13q-/no abberation||
1696014|NCT01039376|3118366|Superiority||Mean Difference (Final Values)|1.38||||0.1999|2-Sided|95.0|-0.73|3.49||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Thermometer Score||
1696015|NCT01039376|3118366|Superiority||Mean Difference (Final Values)|0.03||||0.011|2-Sided|95.0|0.01|0.06||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Utility Score||
1696016|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|-1.79||||0.3209|2-Sided|95.0|-5.33|1.75||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Insomnia||
1696017|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|3.65||||0.0175|2-Sided|95.0|0.64|6.65||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Social Functioning||
1696018|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|3.56||||0.0259|2-Sided|95.0|0.43|6.7||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Role Functioning||
1696019|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|1.78||||0.1449|2-Sided|95.0|-0.61|4.17||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Global Health Status/QOL||
1696020|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|1.81||||0.0968|2-Sided|95.0|-0.33|3.96||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Physical Functioning||
1696021|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|-3.04||||0.0393|2-Sided|95.0|-5.93|-0.15||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Pain||
1696022|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|-1.22||||0.0606|2-Sided|95.0|-2.49|0.05||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Nausea and Vomiting||
1696023|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|-1.76||||0.2902|2-Sided|95.0|-5.02|1.51||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Financial Difficulties||
1696024|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|-4.63||||0.0013|2-Sided|95.0|-7.45|-1.82||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Fatigue||
1696025|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|3.89||||0.0037|2-Sided|95.0|1.27|6.51||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Emotional Functioning||
1696026|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|-2.32||||0.0963|2-Sided|95.0|-5.06|0.42||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Dyspnoea||
1696027|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|0.5||||0.6533|2-Sided|95.0|-1.67|2.66||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Diarrhoea||
1696028|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|-1.97||||0.0932|2-Sided|95.0|-4.28|0.33||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Constipation||
1696029|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|1.4||||0.2863|2-Sided|95.0|-1.18|3.97||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Cognitive Functioning||
1696030|NCT01039376|3118367|Superiority||Mean Difference (Final Values)|-1.48||||0.1816|2-Sided|95.0|-3.64|0.69||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Appetite Loss||
1696169|NCT01036022|3118548|Superiority or Other||Ratio|1.44|||||2-Sided|95.0|0.31|6.59||||||Placebo versus GSK1399686 10 mg for Week 6 fecal lactoferrin levels|
1696031|NCT01039376|3118368|Superiority||Mean Difference (Final Values)|-2.49||||0.0063|2-Sided|95.0|-4.27|-0.71||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Side Effects Scale||
1696032|NCT01039376|3118368|Superiority||Mean Difference (Final Values)|-4.32||||0.0055|2-Sided|95.0|-7.37|-1.28||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Social Problems Scale||
1696033|NCT01039376|3118368|Superiority||Mean Difference (Final Values)|0.52||||0.6398|2-Sided|95.0|-1.67|2.72||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Infection Scale||
1696034|NCT01039376|3118368|Superiority||Mean Difference (Final Values)|-3.58||||0.0642|2-Sided|95.0|-7.37|0.21||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Future Health Scale||
1696035|NCT01039376|3118368|Superiority||Mean Difference (Final Values)|-3.79||||0.0085|2-Sided|95.0|-6.61|-0.97||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Fatigue Scale||
1696036|NCT01039376|3118368|Superiority||Mean Difference (Final Values)|-2.19||||0.0199|2-Sided|95.0|-4.04|-0.35||The analysis is adjusted for BL score, actual strata, age group, BL ECOG performance status and Binet stage at Screening using mixed-model (Proc Mixed) repeated with intercept, BL score by time and treatment by time interaction.|Repeated measures analysis of covariance||Disease Effects Scale||
1696037|NCT01039376|3118369|Superiority||Hazard Ratio (HR)|0.59||||0.1603|2-Sided|95.0|0.29|1.19|||log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of <1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.||
1696038|NCT01039376|3118370|Superiority||Hazard Ratio (HR)|0.74||||0.3136|2-Sided|95.0|0.42|1.32|||log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of <1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.||
1696039|NCT01039376|3118371|Superiority||Hazard Ratio (HR)|0.77||||0.0178|2-Sided|95.0|0.62|0.96|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of <1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.||
1696040|NCT01039376|3118373|Superiority||Hazard Ratio (HR)|0.93||||0.6046|2-Sided|95.0|0.69|1.25|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of <1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.||
1696041|NCT01039376|3118374|Superiority||Hazard Ratio (HR)|0.54|||<|0.0001|2-Sided|95.0|0.42|0.68|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of <1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.||
1696042|NCT01039376|3118375|Superiority||Hazard Ratio (HR)|0.55|||<|0.0001|2-Sided|95.0|0.43|0.7|||Stratified log rank test||Hazard ratios were obtained using the Pike estimator. A hazard ratio of <1 indicated a lower risk with ofatumumab maintenance compared with no further treatment.||
1696043|NCT01038921|3118384|Superiority or Other||Mean Difference (Final Values)|6.0||||0.013|||||||Mixed Models Analysis|||Average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those subjects were on Melatonin was compared to the average change in systolic blood pressure from pre-treatment baseline to post-treatment at 10 weeks when those same subjects were on Placebo using an intent-to-treat mixed model. Power was estimated based on having 30 subjects completing both the melatonin arm and the placebo arm.|
1696044|NCT01038713|3118405|Superiority or Other|||||||1|||||||ANOVA||||
1696045|NCT01038713|3118406|Superiority or Other|||||||0.96|||||||Chi-squared|3 x 2 contingency table comparing all three groups||Analysis comparing the rate of death between groups|
1696046|NCT01038713|3118406|Superiority or Other|||||||0.14|||||||Chi-squared|3 x 2 contingency table comparing all three groups||Analysis comparing the rate of attempted surgical resection|
1696047|NCT01038713|3118406|Superiority or Other|||||||0.22||||||Analysis comparing the number of patients who had stent occlusion|Chi-squared|3 x 2 contingency table comparing all three groups|||
1696048|NCT01038635|3118409|Superiority or Other||Maximal tolerated dose|75.0|||||2-Sided||||||||Maximal tolerated dose not reached as no dose limiting toxicity documented. MTD considered to be last dose level.||
1696049|NCT01038336|3118427|Superiority or Other|||||||0.128|||||||ANOVA||||
1696050|NCT01038336|3118428|Superiority or Other|||||||0.454|||||||ANOVA||||
1696051|NCT01038336|3118429|Superiority or Other|||||||0.832|||||||ANOVA||||
1696052|NCT01038336|3118430|Superiority or Other|||||||0.092|||||||ANOVA||||
1696053|NCT01038336|3118431|Superiority or Other|||||||0.03|||||||ANOVA||||
1696054|NCT01038336|3118432|Superiority or Other|||||||0.072|||||||ANOVA||||
1696055|NCT01038336|3118433|Superiority or Other|||||||0.004|||||||ANOVA||||
1696056|NCT01038336|3118434|Superiority or Other|||||||0.289|||||||Chi-squared||||
1696057|NCT01037881|3118448|Superiority||Difference in least squares mean|0.81||||0.47|2-Sided|95.0|-1.38|3.0|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.|
1696058|NCT01037881|3118448|Superiority||Difference in least squares mean|0.9||||0.42|2-Sided|95.0|-1.31|3.1|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.|
1696059|NCT01037881|3118448|Superiority||Difference in least squares mean|0.45||||0.7|2-Sided|95.0|-1.84|2.73|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.|
1696060|NCT01037881|3118448|Superiority||Difference in least squares mean|2.21||||0.06|2-Sided|95.0|-0.08|4.5|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.|
1696061|NCT01037881|3118448|Superiority||Difference in least squares mean|1.17||||0.32|2-Sided|95.0|-1.14|3.48|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.|
1696062|NCT01037881|3118448|Superiority||Difference in least squares mean|2.46||||0.04|2-Sided|95.0|0.17|4.74|||ANOVA|||LEO 29102 treatment minus Elidel, adjusted for the effect of (pooled) country.|
1696063|NCT01037881|3118448|Superiority||Difference in least squares mean|-2.46||||0.04|2-Sided|95.0|-4.47|-0.17|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.|
1696064|NCT01037881|3118448|Superiority||Difference in least squares mean|-1.65||||0.14|2-Sided|95.0|-3.84|0.54|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.|
1696065|NCT01037881|3118448|Superiority||Difference in least squares mean|-1.56||||0.16|2-Sided|95.0|-3.77|0.65|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.|
1696066|NCT01037881|3118448|Superiority||Difference in least squares mean|-2.01||||0.08|2-Sided|95.0|-4.3|0.28|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.|
1696067|NCT01037881|3118448|Superiority||Difference in least squares mean|-0.25||||0.83|2-Sided|95.0|-2.53|2.04|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.|
1696068|NCT01037881|3118448|Superiority||Difference in least squares mean|-1.29||||0.27|2-Sided|95.0|-3.6|1.03|||ANOVA|||Active treatment minus vehicle, adjusted for the effect of (pooled) country.|
1696069|NCT01037244|3118456|Superiority or Other||Difference in LS Means|37.8|||<|0.0001|2-Sided|95.0|30.57|45.03|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696070|NCT01037244|3118456|Superiority or Other||Difference in LS Means|27.58|||<|0.0001|2-Sided|95.0|20.29|34.88|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696071|NCT01037244|3118456|Superiority or Other||Difference in LS Means|19.98|||<|0.0001|2-Sided|95.0|12.69|27.26|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696072|NCT01037244|3118457|Superiority or Other||Difference in LS Means|36.99|||<|0.0001|2-Sided|95.0|29.63|44.36|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696073|NCT01037244|3118457|Superiority or Other||Difference in LS Means|25.25|||<|0.0001|2-Sided|95.0|17.82|32.69|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696074|NCT01037244|3118457|Superiority or Other||Difference in LS Means|18.2|||<|0.0001|2-Sided|95.0|10.79|25.6|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696075|NCT01037244|3118458|Superiority or Other||Difference in LS Means|36.25|||<|0.0001|2-Sided|95.0|28.92|43.59|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696086|NCT01037244|3118461|Superiority or Other||Difference in LS Means|0.57|||<|0.0019|2-Sided|95.0|0.21|0.93|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696076|NCT01037244|3118458|Superiority or Other||Difference in LS Means|23.53|||<|0.0001|2-Sided|95.0|16.12|30.94|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696077|NCT01037244|3118458|Superiority or Other||Difference in LS Means|18.07|||<|0.0001|2-Sided|95.0|10.7|25.43|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696078|NCT01037244|3118459|Superiority or Other||Difference in LS Means|19.16|||<|0.0001|2-Sided|95.0|14.14|24.18|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled sites as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696079|NCT01037244|3118459|Superiority or Other||Difference in LS Means|19.29|||<|0.0001|2-Sided|95.0|14.23|24.36|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696080|NCT01037244|3118459|Superiority or Other||Difference in LS Means|12.34|||<|0.0001|2-Sided|95.0|7.29|17.4|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696081|NCT01037244|3118460|Superiority or Other||Difference in LS Means|2.56|||<|0.0001|2-Sided|95.0|2.03|3.09|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696082|NCT01037244|3118460|Superiority or Other||Difference in LS Means|1.76|||<|0.0001|2-Sided|95.0|1.23|2.29|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696083|NCT01037244|3118460|Superiority or Other||Difference in LS Means|1.66|||<|0.0001|2-Sided|95.0|1.13|2.19|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696084|NCT01037244|3118461|Superiority or Other||Difference in LS Means|0.85|||<|0.0001|2-Sided|95.0|0.49|1.21|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696085|NCT01037244|3118461|Superiority or Other||Difference in LS Means|0.74|||<|0.0001|2-Sided|95.0|0.38|1.1|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696154|NCT01037127|3118494|Superiority or Other||percentage of participants|25.0|||||2-Sided|95.0|14.1|37.8|||||The estimated value reflects the percentage of particpants with CR and PR.||
1696155|NCT01037088|3118505|Superiority||||||=|0|||||||Mixed Models Analysis|||Hour 5 after Administration of Cannabis|
1696156|NCT01037088|3118505|Superiority||||||=|0|||||||Mixed Models Analysis|||Hour 4 after Administration of Cannabis|
1696087|NCT01037244|3118462|Superiority or Other||Difference in LS Means|1.98|||<|0.0001|2-Sided|95.0|1.37|2.59|||ANCOVA|P-values are obtained from ANCOVA model with baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696088|NCT01037244|3118462|Superiority or Other||Difference in LS Means|1.65|||<|0.0001|2-Sided|95.0|1.04|2.26|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696089|NCT01037244|3118462|Superiority or Other||Difference in LS Means|1.42|||<|0.0001|2-Sided|95.0|0.81|2.03|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696090|NCT01037244|3118463|Superiority or Other||Difference in LS Means|3.02|||<|0.0001|2-Sided|95.0|2.3|3.73|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696091|NCT01037244|3118463|Superiority or Other||Difference in LS Means|2.27|||<|0.0001|2-Sided|95.0|1.54|2.99|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696092|NCT01037244|3118463|Superiority or Other||Difference in LS Means|1.89|||<|0.0001|2-Sided|95.0|1.17|2.61|||ANCOVA|P-values were obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696093|NCT01037244|3118464|Superiority or Other||Difference in LS Means|28.39|||<|0.0001|2-Sided|95.0|22.98|33.79|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696094|NCT01037244|3118464|Superiority or Other||Difference in LS Means|22.57|||<|0.0001|2-Sided|95.0|17.11|28.03|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696095|NCT01037244|3118464|Superiority or Other||Difference in LS Means|16.67|||<|0.0001|2-Sided|95.0|11.23|22.11|||ANOVA|p-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696096|NCT01037244|3118465|Superiority or Other||Difference in LS Means|0.8|||<|0.0001|2-Sided|95.0|0.66|0.95|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696097|NCT01037244|3118465|Superiority or Other||Difference in LS Means|0.68|||<|0.0001|2-Sided|95.0|0.54|0.83|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696098|NCT01037244|3118465|Superiority or Other||Difference in LS Means|0.44|||<|0.0001|2-Sided|95.0|0.3|0.59|||ANCOVA|p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696099|NCT01037244|3118466|Superiority or Other||||||<|0.0001|||||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696100|NCT01037244|3118466|Superiority or Other||||||<|0.0001|||||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696101|NCT01037244|3118466|Superiority or Other||||||<|0.0001|||||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696102|NCT01037244|3118466|Superiority or Other||||||<|0.0001|||||||Cochran-Armitage test|||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696103|NCT01037244|3118467|Superiority or Other||Difference in LS Means|31.51|||<|0.0001|2-Sided|95.0|24.68|38.34|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696104|NCT01037244|3118467|Superiority or Other||Difference in LS Means|29.02|||<|0.0001|2-Sided|95.0|22.13|35.9|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696105|NCT01037244|3118467|Superiority or Other||Difference in LS Means|18.6|||<|0.0001|2-Sided|95.0|11.72|25.48|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696106|NCT01037244|3118468|Superiority or Other||Difference in LS Means|7.95|||<|0.0001|2-Sided|95.0|6.27|9.63|||ANCOVA|Baseline domain score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696107|NCT01037244|3118468|Superiority or Other||Difference in LS Means|7.18|||<|0.0001|2-Sided|95.0|5.49|8.86|||ANCOVA|Baseline domain score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696108|NCT01037244|3118468|Superiority or Other||Difference in Least Square (LS) Means|5.04|||<|0.0001|2-Sided|95.0|3.36|6.73|||ANCOVA|Baseline Domain Score and pooled sites as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure.|
1696157|NCT01037088|3118505|Superiority||||||<|0.0001|||||||Mixed Models Analysis|||Hour 3 after Administration of Cannabis (after the second inhalation of cannabis)|
1696158|NCT01037088|3118505|Superiority||||||=|0|||||||Mixed Models Analysis|||Hour 2 after Administration of Cannabis|
1696159|NCT01037088|3118505|Superiority||||||>|0.05||||||not significant|Mixed Models Analysis|||Hour 1 after Administration of Cannabis|
1696109|NCT01037218|3118469|Superiority or Other||Difference in LS Means|34.35|||<|0.0001|2-Sided|95.0|26.94|41.75|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001(NCT00282607).|
1696110|NCT01037218|3118469|Superiority or Other||Difference in LS Means|29.39|||<|0.0001|2-Sided|95.0|21.86|36.92|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696111|NCT01037218|3118469|Superiority or Other||Difference in LS Means|18.73|||<|0.0001|2-Sided|95.0|11.23|26.23|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696112|NCT01037218|3118470|Superiority or Other||Difference in LS Means|33.82|||<|0.0001|2-Sided|95.0|26.61|41.02|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696113|NCT01037218|3118470|Superiority or Other||Difference in LS Means|28.32|||<|0.0001|2-Sided|95.0|21.01|35.62|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696114|NCT01037218|3118470|Superiority or Other||Difference in LS Means|17.51|||<|0.0001|2-Sided|95.0|10.22|24.81|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696115|NCT01037218|3118471|Superiority or Other||Difference in LS Means|21.06|||<|0.0001|2-Sided|95.0|16.15|25.96|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696116|NCT01037218|3118471|Superiority or Other||Difference in LS Means|14.94|||<|0.0001|2-Sided|95.0|9.96|19.92|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696117|NCT01037218|3118471|Superiority or Other||Difference in LS Means|15.18|||<|0.0001|2-Sided|95.0|10.21|20.14|||ANCOVA|"P-values are obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696118|NCT01037218|3118472|Superiority or Other||Difference in LS Means|0.83|||<|0.0001|2-Sided|95.0|0.69|0.97|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696160|NCT01036490|3118524|Superiority or Other|||||||0.58|||||||t-test, 2 sided||||
1696119|NCT01037218|3118472|Superiority or Other||Difference in LS Means|0.54|||<|0.0001|2-Sided|95.0|0.4|0.68|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696120|NCT01037218|3118472|Superiority or Other||Difference in LS Means|0.44|||<|0.0001|2-Sided|95.0|0.3|0.57|||ANCOVA|P-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696121|NCT01037218|3118473|Superiority or Other||Difference in LS Means|27.01|||<|0.0001|2-Sided|95.0|21.44|32.59|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696122|NCT01037218|3118473|Superiority or Other||Difference in LS Means|19.61|||<|0.0001|2-Sided|95.0|13.95|25.27|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696123|NCT01037218|3118473|Superiority or Other||Difference in LS Means|12.65|||<|0.0001|2-Sided|95.0|7.01|18.29|||ANOVA|P-values are obtained from ANOVA model with pooled site as a covariate.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696124|NCT01037218|3118474|Superiority or Other||||||<|0.0001|||||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696125|NCT01037218|3118474|Superiority or Other||||||<|0.0001|||||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696126|NCT01037218|3118474|Superiority or Other||||||<|0.0001|||||||Chi-squared|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696127|NCT01037218|3118474|Superiority or Other||||||<|0.0001|||||||Cochran-Armitage test|||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696128|NCT01037218|3118475|Superiority or Other||Difference in LS Means|2.09|||<|0.0001|2-Sided|95.0|1.55|2.62|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696129|NCT01037218|3118475|Superiority or Other||Difference in LS Means|1.55|||<|0.0001|2-Sided|95.0|1.01|2.09|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696161|NCT01036490|3118525|Superiority or Other|||||||0.15|||||||t-test, 2 sided||||
1696162|NCT01036490|3118528|Superiority or Other|||||||0.39|||||||t-test, 2 sided||||
1696163|NCT01036490|3118529|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1696130|NCT01037218|3118475|Superiority or Other||Difference in LS Means|0.86|||<|0.0019|2-Sided|95.0|0.32|1.4|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696131|NCT01037218|3118476|Superiority or Other||Difference in LS Means|0.71||||0.0001|2-Sided|95.0|0.34|1.07|||ANCOVA|P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696132|NCT01037218|3118476|Superiority or Other||Difference in LS Means|0.71||||0.0002|2-Sided|95.0|0.34|1.08|||ANCOVA|P-values obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696133|NCT01037218|3118476|Superiority or Other||Difference in LS Means|0.36||||0.0566|2-Sided|95.0|-0.01|0.73|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696134|NCT01037218|3118477|Superiority or Other||Difference in LS Means|1.53|||<|0.0001|2-Sided|95.0|0.91|2.15|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696135|NCT01037218|3118477|Superiority or Other||Difference in LS Means|1.53|||<|0.0001|2-Sided|95.0|0.9|2.16|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696136|NCT01037218|3118477|Superiority or Other||Difference in LS Means|0.59|||<|0.0673|2-Sided|95.0|-0.04|1.22|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696137|NCT01037218|3118478|Superiority or Other||Difference in LS Means|2.9|||<|0.0001|2-Sided|95.0|2.2|3.6|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696138|NCT01037218|3118478|Superiority or Other||Difference in LS Means|2.29|||<|0.0001|2-Sided|95.0|1.58|3.0|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696139|NCT01037218|3118478|Superiority or Other||Difference in LS Means|1.52|||<|0.0001|2-Sided|95.0|0.81|2.23|||ANCOVA|P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696164|NCT01036165|3118543|Superiority or Other||Mean positive response|0.78|||||2-Sided|95.0|0.7|0.86|||||Confidence Interval calculated from normal approximation to the binomial. The primary objective was met if the lower limit of the 95% confidence interval was >0.50.||
1696165|NCT01036022|3118548|Superiority or Other||Ratio|0.84|||||2-Sided|95.0|0.27|2.62||||||Placebo versus Asacol for Week 6 fecal lactoferrin levels|
1696140|NCT01037218|3118479|Superiority or Other||Difference in LS Means|35.41|||<|0.0001|2-Sided|95.0|27.98|42.83|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696141|NCT01037218|3118479|Superiority or Other||Difference in LS Means|26.82|||<|0.0001|2-Sided|95.0|19.27|34.37|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696142|NCT01037218|3118479|Superiority or Other||Difference in LS Means|21.72|||<|0.0001|2-Sided|95.0|14.19|29.24|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696143|NCT01037218|3118480|Superiority or Other||Difference in LS Means|32.84|||<|0.0001|2-Sided|95.0|26.18|39.5|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696144|NCT01037218|3118480|Superiority or Other||Difference in LS Means|25.06|||<|0.0001|2-Sided|95.0|18.32|31.81|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696145|NCT01037218|3118480|Superiority or Other||Difference in LS Means|20.19|||<|0.0001|2-Sided|95.0|13.44|26.93|||ANCOVA|"P-values were obtained from ANCOVA model with proportion of yes responses during the baseline period and pooled site as covariates."||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696146|NCT01037218|3118481|Superiority or Other||Difference in LS Means|7.53|||<|0.0001|2-Sided|95.0|5.86|9.2|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696147|NCT01037218|3118481|Superiority or Other||Difference in LS Means|5.74|||<|0.0001|2-Sided|95.0|4.05|7.43|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696148|NCT01037218|3118481|Superiority or Other||Difference in LS Means|3.38|||<|0.0001|2-Sided|95.0|1.7|5.07|||ANCOVA|Baseline domain score and pooled site as covariates.||540 subjects were randomized with 1:1:1:1 randomization scheme to the 4 treatment groups (placebo and udenafil 50mg, 100mg or 150mg). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. Considerations are based on results from Phase 2, Dong-A Study DA 2005-001 (NCT00282607).|
1696149|NCT01037127|3118492|Superiority or Other||percentage of participants|20.0||||||95.0|7.7|38.6|||||The estimated value reflects the percentage of particpants with CR and PR.||
1696150|NCT01037127|3118493|Superiority or Other||percentage of participants|28.0|||||2-Sided|95.0|14.2|45.2|||||The estimated value reflects the percentage of particpants with CR and PR.||
1696151|NCT01037127|3118493|Superiority or Other||percentage of participants|26.0|||||2-Sided|95.0|14.3|41.4|||||The estimated value reflects the percentage of particpants with CR and PR.||
1696152|NCT01037127|3118493|Superiority or Other||percentage of participants|27.0|||||2-Sided|95.0|14.6|41.9|||||The estimated value reflects the percentage of particpants with CR and PR.||
1696153|NCT01037127|3118493|Superiority or Other||percentage of participants|17.0|||||2-Sided|95.0|2.1|48.4|||||The estimated value reflects the percentage of particpants with CR and PR.||
1696170|NCT01036022|3118548|Superiority or Other||Ratio|0.82|||||2-Sided|95.0|0.29|2.33||||||Placebo versus Asacol for Week 5 fecal lactoferrin levels|
1696171|NCT01036022|3118548|Superiority or Other||Ratio|1.16|||||2-Sided|95.0|0.36|3.73||||||Placebo versus GSK1399686 300 mg for Week 5 fecal lactoferrin levels|
1696172|NCT01036022|3118548|Superiority or Other||Ratio|0.33|||||2-Sided|95.0|0.11|1.02||||||Placebo versus GSK1399686 100 mg for Week 5 fecal lactoferrin levels|
1696173|NCT01036022|3118548|Superiority or Other||Ratio|1.48|||||2-Sided|95.0|0.46|4.73||||||Placebo versus GSK1399686 30 mg for Week 5 fecal lactoferrin levels|
1696174|NCT01036022|3118548|Superiority or Other||Ratio|1.05|||||2-Sided|95.0|0.27|4.07||||||Placebo versus GSK1399686 10 mg for Week 5 fecal lactoferrin levels|
1696175|NCT01036022|3118548|Superiority or Other||Ratio|0.71|||||2-Sided|95.0|0.26|1.89||||||Placebo versus Asacol for Week 4 fecal lactoferrin levels|
1696176|NCT01036022|3118548|Superiority or Other||Ratio|1.19|||||2-Sided|95.0|0.38|3.7||||||Placebo versus GSK1399686 300 mg for Week 4 fecal lactoferrin levels|
1696177|NCT01036022|3118548|Superiority or Other||Ratio|0.56|||||2-Sided|95.0|0.19|1.68||||||Placebo versus GSK1399686 100 mg for Week 4 fecal lactoferrin levels|
1696178|NCT01036022|3118548|Superiority or Other||Ratio|0.68|||||2-Sided|95.0|0.23|2.03||||||Placebo versus GSK1399686 30 mg for Week 4 fecal lactoferrin levels|
1696179|NCT01036022|3118548|Superiority or Other||Ratio|0.33|||||2-Sided|95.0|0.1|1.15||||||Placebo versus GSK1399686 10 mg for Week 4 fecal lactoferrin levels|
1696180|NCT01036022|3118548|Superiority or Other||Ratio|0.37|||||2-Sided|95.0|0.14|1.01||||||Placebo versus Asacol for Week 3 fecal lactoferrin levels|
1696181|NCT01036022|3118548|Superiority or Other||Ratio|1.42|||||2-Sided|95.0|0.45|4.46||||||Placebo versus GSK1399686 300 mg for Week 3 fecal lactoferrin levels|
1696182|NCT01036022|3118548|Superiority or Other||Ratio|0.52|||||2-Sided|95.0|0.17|1.56||||||Placebo versus GSK1399686 100 mg for Week 3 fecal lactoferrin levels|
1696183|NCT01036022|3118548|Superiority or Other||Ratio|0.96|||||2-Sided|95.0|0.32|2.87||||||Placebo versus GSK1399686 30 mg for Week 3 fecal lactoferrin levels|
1696184|NCT01036022|3118548|Superiority or Other||Ratio|0.53|||||2-Sided|95.0|0.15|1.84||||||Placebo versus GSK1399686 10 mg for Week 3 fecal lactoferrin levels|
1696185|NCT01036022|3118548|Superiority or Other||Ratio|0.7|||||2-Sided|95.0|0.26|1.87||||||Placebo versus Asacol for Week 2 fecal lactoferrin levels|
1696186|NCT01036022|3118548|Superiority or Other||Ratio|0.93|||||2-Sided|95.0|0.31|2.77||||||Placebo versus GSK1399686 300 mg for Week 2 fecal lactoferrin levels|
1696187|NCT01036022|3118548|Superiority or Other||Ratio|0.35|||||2-Sided|95.0|0.12|1.0||||||Placebo versus GSK1399686 100 mg for Week 2 fecal lactoferrin levels|
1696188|NCT01036022|3118548|Superiority or Other||Ratio|0.59|||||2-Sided|95.0|0.22|1.63||||||Placebo versus GSK1399686 30 mg for Week 2 fecal lactoferrin levels|
1696189|NCT01036022|3118548|Superiority or Other||Ratio|0.76|||||2-Sided|95.0|0.26|2.19||||||Placebo versus GSK1399686 10 mg for Week 2 fecal lactoferrin levels|
1696190|NCT01036022|3118548|Superiority or Other||Ratio|1.28|||||2-Sided|95.0|0.5|3.28||||||Placebo versus Asacol for Week 1 fecal lactoferrin levels|
1696191|NCT01036022|3118548|Superiority or Other||Ratio|1.26|||||2-Sided|95.0|0.44|3.59||||||Placebo versus GSK1399686 300 mg for Week 1 fecal lactoferrin levels|
1696192|NCT01036022|3118548|Superiority or Other||Ratio|1.25|||||2-Sided|95.0|0.45|3.47||||||Placebo versus GSK1399686 100 mg for Week 1 fecal lactoferrin levels|
1696193|NCT01036022|3118548|Superiority or Other||Ratio|1.35|||||2-Sided|95.0|0.5|3.65||||||Placebo versus GSK1399686 30 mg for Week 1 fecal lactoferrin levels|
1696194|NCT01036022|3118548|Superiority or Other||Ratio|1.19|||||2-Sided|95.0|0.42|3.38||||||Placebo versus GSK1399686 10 mg for Week 1 fecal lactoferrin levels|
1696195|NCT01036022|3118549|Superiority or Other||Ratio|0.72|||||2-Sided|95.0|0.21|2.49||||||Placebo versus Asacol for Week 6 fecal calprotectin levels|
1696196|NCT01036022|3118549|Superiority or Other||Ratio|0.76|||||2-Sided|95.0|0.19|2.99||||||Placebo versus GSK1399686 300 mg for Week 6 fecal calprotectin levels|
1696197|NCT01036022|3118549|Superiority or Other||Ratio|0.37|||||2-Sided|95.0|0.09|1.48||||||Placebo versus GSK1399686 100 mg for Week 6 fecal calprotectin levels|
1696198|NCT01036022|3118549|Superiority or Other||Ratio|0.44|||||2-Sided|95.0|0.11|1.84||||||Placebo versus GSK1399686 30 mg for Week 6 fecal calprotectin levels|
1696199|NCT01036022|3118549|Superiority or Other||Ratio|0.66|||||2-Sided|95.0|0.13|3.39||||||Placebo versus GSK1399686 10 mg for Week 6 fecal calprotectin levels|
1696200|NCT01036022|3118549|Superiority or Other||Ratio|0.47|||||2-Sided|95.0|0.15|1.48||||||Placebo versus Asacol for Week 5 fecal calprotectin levels|
1696201|NCT01036022|3118549|Superiority or Other||Ratio|0.41|||||2-Sided|95.0|0.11|1.46||||||Placebo versus GSK1399686 300 mg for Week 5 fecal calprotectin levels|
1696202|NCT01036022|3118549|Superiority or Other||Ratio|0.71|||||2-Sided|95.0|0.2|2.47||||||Placebo versus GSK1399686 100 mg for Week 5 fecal calprotectin levels|
1696203|NCT01036022|3118549|Superiority or Other||Ratio|1.25|||||2-Sided|95.0|0.35|4.38||||||Placebo versus GSK1399686 30 mg for Week 5 fecal calprotectin levels|
1696204|NCT01036022|3118549|Superiority or Other||Ratio|0.61|||||2-Sided|95.0|0.14|2.66||||||Placebo versus GSK1399686 10 mg for Week 5 fecal calprotectin levels|
1696205|NCT01036022|3118549|Superiority or Other||Ratio|0.82|||||2-Sided|95.0|0.28|2.42||||||Placebo versus Asacol for Week 4 fecal calprotectin levels|
1696206|NCT01036022|3118549|Superiority or Other||Ratio|1.36|||||2-Sided|95.0|0.39|4.72||||||Placebo versus GSK1399686 300 mg for Week 4 fecal calprotectin levels|
1696207|NCT01036022|3118549|Superiority or Other||Ratio|0.96|||||2-Sided|95.0|0.29|3.23||||||Placebo versus GSK1399686 100 mg for Week 4 fecal calprotectin levels|
1696208|NCT01036022|3118549|Superiority or Other||Ratio|0.64|||||2-Sided|95.0|0.2|2.02||||||Placebo versus GSK1399686 30 mg for Week 4 fecal calprotectin levels|
1696209|NCT01036022|3118549|Superiority or Other||Ratio|1.29|||||2-Sided|95.0|0.33|5.04||||||Placebo versus GSK1399686 10 mg for Week 4 fecal calprotectin levels|
1696210|NCT01036022|3118549|Superiority or Other||Ratio|0.44|||||2-Sided|95.0|0.15|1.32||||||Placebo versus Asacol for Week 3 fecal calprotectin levels|
1696211|NCT01036022|3118549|Superiority or Other||Ratio|0.6|||||2-Sided|95.0|0.17|2.08||||||Placebo versus GSK1399686 300 mg for Week 3 fecal calprotectin levels|
1696212|NCT01036022|3118549|Superiority or Other||Ratio|0.62|||||2-Sided|95.0|0.18|2.08||||||Placebo versus GSK1399686 100 mg for Week 3 fecal calprotectin levels|
1696213|NCT01036022|3118549|Superiority or Other||Ratio|0.74|||||2-Sided|95.0|0.23|2.43||||||Placebo versus GSK1399686 30 mg for Week 3 fecal calprotectin levels|
1696214|NCT01036022|3118549|Superiority or Other||Ratio|1.07|||||2-Sided|95.0|0.28|4.09||||||Placebo versus GSK1399686 10 mg for Week 3 fecal calprotectin levels|
1696215|NCT01036022|3118549|Superiority or Other||Ratio|0.64|||||2-Sided|95.0|0.22|1.9||||||Placebo versus Asacol for Week 2 fecal calprotectin levels|
1696216|NCT01036022|3118549|Superiority or Other||Ratio|0.62|||||2-Sided|95.0|0.19|2.03||||||Placebo versus GSK1399686 300 mg for Week 2 fecal calprotectin levels|
1696217|NCT01036022|3118549|Superiority or Other||Ratio|0.67|||||2-Sided|95.0|0.21|2.18||||||Placebo versus GSK1399686 100 mg for Week 2 fecal calprotectin levels|
1696218|NCT01036022|3118549|Superiority or Other||Ratio|0.55|||||2-Sided|95.0|0.18|1.68||||||Placebo versus GSK1399686 30 mg for Week 2 fecal calprotectin levels|
1696219|NCT01036022|3118549|Superiority or Other||Ratio|0.85|||||2-Sided|95.0|0.26|2.73||||||Placebo versus GSK1399686 10 mg for Week 2 fecal calprotectin levels|
1696220|NCT01036022|3118549|Superiority or Other||Ratio|0.64|||||2-Sided|95.0|0.23|1.81||||||Placebo versus Asacol for Week 1 fecal calprotectin levels|
1696221|NCT01036022|3118549|Superiority or Other||Ratio|0.85|||||2-Sided|95.0|0.27|2.68||||||Placebo versus GSK1399686 300 mg for Week 1 fecal calprotectin levels|
1696222|NCT01036022|3118549|Superiority or Other||Ratio|0.8|||||2-Sided|95.0|0.26|2.48||||||Placebo versus GSK1399686 100 mg for Week 1 fecal calprotectin levels|
1696223|NCT01036022|3118549|Superiority or Other||Ratio|0.64|||||2-Sided|95.0|0.21|1.92||||||Placebo versus GSK1399686 30 mg for Week 1 fecal calprotectin levels|
1696224|NCT01036022|3118549|Superiority or Other||Ratio|0.75|||||2-Sided|95.0|0.24|2.39||||||Placebo versus GSK1399686 10 mg for Week 1 fecal calprotectin levels|
1696225|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.4||||0.2511|2-Sided|95.0|-1.1|3.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 6 SCCAI score|
1696226|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.6||||0.6038|2-Sided|95.0|-1.8|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 6 SCCAI score|
1696227|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.3||||0.2809|2-Sided|95.0|-1.1|3.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 6 SCCAI score|
1696228|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.5||||0.2604|2-Sided|95.0|-1.1|4.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 6 SCCAI score|
1696229|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.0||||0.4091|2-Sided|95.0|-1.4|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 5 SCCAI score|
1696230|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.8||||0.5238|2-Sided|95.0|-1.7|3.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 5 SCCAI score|
1696231|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.1||||0.3478|2-Sided|95.0|-1.3|3.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 5 SCCAI score|
1696232|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.8||||0.1493|2-Sided|95.0|-0.7|4.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 5 SCCAI score|
1696233|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.8||||0.5122|2-Sided|95.0|-1.5|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 4 SCCAI score|
1696234|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.9594|2-Sided|95.0|-2.3|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 4 SCCAI score|
1696235|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.8||||0.4567|2-Sided|95.0|-1.4|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 4 SCCAI score|
1696236|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.8||||0.4644|2-Sided|95.0|-1.4|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 4 SCCAI score|
1696237|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.2||||0.2455|2-Sided|95.0|-0.9|3.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 3 SCCAI score|
1696238|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9665|2-Sided|95.0|-2.0|2.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 3 SCCAI score|
1696283|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|174.9||||0.2865|2-Sided|95.0|-150.6|500.5|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH effect|
1696239|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.5||||0.1392|2-Sided|95.0|-0.5|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 3 SCCAI score|
1696240|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.6||||0.5824|2-Sided|95.0|-1.5|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 3 SCCAI score|
1696241|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.3||||0.1786|2-Sided|95.0|-0.6|3.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 2 SCCAI score|
1696242|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.2||||0.7995|2-Sided|95.0|-1.7|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 2 SCCAI score|
1696243|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.5||||0.1153|2-Sided|95.0|-0.4|3.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 2 SCCAI score|
1696244|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.9||||0.3247|2-Sided|95.0|-1.0|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 2 SCCAI score|
1696245|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.8||||0.3578|2-Sided|95.0|-0.9|2.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 300 mg for Week 1 SCCAI score|
1696246|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.2||||0.7914|2-Sided|95.0|-1.5|2.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 100 mg for Week 1 SCCAI score|
1696247|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.2||||0.1764|2-Sided|95.0|-0.5|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 30 mg for Week 1 SCCAI score|
1696248|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.5917|2-Sided|95.0|-2.2|1.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Asacol versus GSK1399686 10 mg for Week 1 SCCAI score|
1696249|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.4378|2-Sided|95.0|-3.1|1.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 6 SCCAI score|
1696250|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.6||||0.6533|2-Sided|95.0|-2.0|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 6 SCCAI score|
1696251|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.8549|2-Sided|95.0|-2.7|2.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 6 SCCAI score|
1696252|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.5||||0.7061|2-Sided|95.0|-2.0|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 6 SCCAI score|
1696253|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.6||||0.6498|2-Sided|95.0|-2.0|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 6 SCCAI score|
1696254|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.5963|2-Sided|95.0|-2.8|1.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 5 SCCAI score|
1696255|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.4||||0.7298|2-Sided|95.0|-2.1|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 5 SCCAI score|
1696256|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.2||||0.8758|2-Sided|95.0|-2.3|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 5 SCCAI score|
1696257|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.6||||0.65|2-Sided|95.0|-1.9|3.0||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 5 SCCAI score|
1696258|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.2||||0.3256|2-Sided|95.0|-1.3|3.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 5 SCCAI score|
1696259|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.4||||0.6985|2-Sided|95.0|-1.6|2.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 4 SCCAI score|
1696340|NCT01034397|3118712|Superiority or Other|||||||0.437|||||||t-test, 1 sided||||
1696260|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.2||||0.3332|2-Sided|95.0|-1.2|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 4 SCCAI score|
1696261|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.3||||0.7655|2-Sided|95.0|-1.9|2.6||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 4 SCCAI score|
1696262|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.2||||0.2799|2-Sided|95.0|-1.0|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 4 SCCAI score|
1696263|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.2||||0.2844|2-Sided|95.0|-1.1|3.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 4 SCCAI score|
1696264|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.662|2-Sided|95.0|-2.3|1.4||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 3 SCCAI score|
1696265|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.8||||0.4556|2-Sided|95.0|-1.3|2.9||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 3 SCCAI score|
1696266|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.7251|2-Sided|95.0|-2.4|1.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 3 SCCAI score|
1696267|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.1||||0.2915|2-Sided|95.0|-0.9|3.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 3 SCCAI score|
1696268|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.2||||0.8707|2-Sided|95.0|-1.9|2.3||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 3 SCCAI score|
1696269|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.4507|2-Sided|95.0|-2.4|1.1||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 2 SCCAI score|
1696270|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.7||||0.5152|2-Sided|95.0|-1.4|2.7||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 2 SCCAI score|
1696271|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.6695|2-Sided|95.0|-2.4|1.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 2 SCCAI score|
1696272|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.8||||0.3869|2-Sided|95.0|-1.1|2.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 2 SCCAI score|
1696273|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.3||||0.7699|2-Sided|95.0|-1.6|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 2 SCCAI score|
1696274|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.2||||0.8069|2-Sided|95.0|-1.4|1.8||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus Asacol for Week 1 SCCAI score|
1696275|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.0||||0.2777|2-Sided|95.0|-0.8|2.8|||Repeated measures mixed model|||Placebo versus GSK1399686 300 mg for Week 1 SCCAI score|
1696276|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|0.4||||0.6302|2-Sided|95.0|-1.3|2.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 100 mg for Week 1 SCCAI score|
1696277|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|1.4||||0.1238|2-Sided|95.0|-0.4|3.2||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 30 mg for Week 1 SCCAI score|
1696278|NCT01036022|3118552|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.7559|2-Sided|95.0|-2.0|1.5||Analysis was adjusted for baseline (Day -1) SCCAI score, Baseline (Screening) Endoscopy Score and Baseline (Screening) UCDAI Score.|Repeated measures mixed model|||Placebo versus GSK1399686 10 mg for Week 1 SCCAI score|
1696279|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-115.2||||0.2614|2-Sided|95.0|-318.5|88.1|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH morning|
1696280|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-273.3||||0.0061|2-Sided|95.0|-465.4|-81.2|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH morning|
1696281|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|45.4||||0.6464|2-Sided|95.0|-151.8|242.7|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH morning|
1696282|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-87.6||||0.4279|2-Sided|95.0|-307.5|132.2|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH morning|
1696341|NCT01034397|3118714|Superiority or Other|||||||1|||||||t-test, 1 sided||||
1696284|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|370.2||||0.0192|2-Sided|95.0|62.6|677.8|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH effect|
1696285|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-29.4||||0.8527|2-Sided|95.0|-345.2|286.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH effect|
1696286|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|123.0||||0.4871|2-Sided|95.0|-229.0|474.9|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH effect|
1696287|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|164.4||||0.1998|2-Sided|95.0|-89.4|418.2|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH 2|
1696288|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|45.3||||0.7069|2-Sided|95.0|-194.5|285.0|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH 2|
1696289|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|24.2||||0.8445|2-Sided|95.0|-222.0|270.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH 2|
1696290|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|9.3||||0.946|2-Sided|95.0|-265.0|283.7|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH 2|
1696291|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-2.2||||0.9823|2-Sided|95.0|-204.1|199.6|||Mixed Models Analysis|||Asacol versus GSK1399686 300 mg for ACTH 1|
1696292|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-317.7||||0.0025|2-Sided|95.0|-519.6|-115.8|||Mixed Models Analysis|||Asacol versus GSK1399686 100 mg for ACTH 1|
1696293|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-8.5||||0.9333|2-Sided|95.0|-210.4|193.4|||Mixed Models Analysis|||Asacol versus GSK1399686 30 mg for ACTH 1|
1696294|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-207.6||||0.0495|2-Sided|95.0|-414.6|-0.5|||Mixed Models Analysis|||Asacol versus GSK1399686 10 mg for ACTH 1|
1696295|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|119.8||||0.1972|2-Sided|95.0|-64.1|303.8|||Mixed Models Analysis|||Placebo versus Asacol for ACTH morning|
1696296|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|4.7||||0.9636|2-Sided|95.0|-198.7|208.0|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH morning|
1696297|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-153.4||||0.1153|2-Sided|95.0|-345.5|38.7|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH morning|
1696298|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|165.3||||0.0988|2-Sided|95.0|-32.0|362.5|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH morning|
1696299|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|32.2||||0.7704|2-Sided|95.0|-187.6|252.0|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH morning|
1696300|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-248.5||||0.0966|2-Sided|95.0|-542.9|46.0|||Mixed Models Analysis|||Placebo versus Asacol for ACTH effect|
1696301|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-73.5||||0.6528|2-Sided|95.0|-399.1|252.0|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH effect|
1696302|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|121.7||||0.4313|2-Sided|95.0|-185.8|429.3|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH effect|
1696303|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-277.9||||0.0834|2-Sided|95.0|-593.7|37.9|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH effect|
1696304|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-125.5||||0.4781|2-Sided|95.0|-477.5|226.5|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH effect|
1696305|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-99.7||||0.3882|2-Sided|95.0|-329.3|129.9|||Mixed Models Analysis|||Placebo versus Asacol for ACTH 2|
1696306|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|64.7||||0.6117|2-Sided|95.0|-189.1|318.5|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH 2|
1696307|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-54.4||||0.6511|2-Sided|95.0|-294.2|185.3|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH 2|
1696308|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-75.5||||0.5417|2-Sided|95.0|-321.7|170.7|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH 2|
1696309|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-90.4||||0.5122|2-Sided|95.0|-364.7|184.0|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH 2|
1696310|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|132.6||||0.1684|2-Sided|95.0|-57.4|322.6|||Mixed Models Analysis|||Placebo versus Asacol for ACTH 1|
1696311|NCT01036022|3118554|Superiority or Other||Median Difference (Net)|130.4||||0.2084|2-Sided|95.0|-74.4|335.1|||Mixed Models Analysis|||Placebo versus GSK1399686 300 mg for ACTH 1|
1696312|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-185.1||||0.0758|2-Sided|95.0|-389.8|19.7|||Mixed Models Analysis|||Placebo versus GSK1399686 100 mg for ACTH 1|
1696313|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|124.1||||0.2309|2-Sided|95.0|-80.6|328.9|||Mixed Models Analysis|||Placebo versus GSK1399686 30 mg for ACTH 1|
1696314|NCT01036022|3118554|Superiority or Other||Mean Difference (Net)|-75.0||||0.4788|2-Sided|95.0|-284.8|134.9|||Mixed Models Analysis|||Placebo versus GSK1399686 10 mg for ACTH 1|
1696315|NCT01035788|3118570|Superiority or Other||Mean Difference (Final Values)|-1.39|Standard Error of the Mean|7.24||0.849|2-Sided|95.0|-1.39|13.2|||Mixed Models Analysis|p value was obtained from the contrast of the linear mixed model||We sought to obtain a sample size of 18 per group to provide 80% power to detect a .97 standard deviation difference in mean change in CAPS between MB-CBCT and the CBCT-Communication Skills at treatment end based on a two-tailed t-test at 5% significance. Linear mixed models with repeated measures were performed to address the primary hypotheses that MB-CBCT would result in a greater improvement for Veterans and their partners than CBCT-Communication Skills at the end of treatment.|
1696316|NCT01035606|3118605|Superiority||||||<|0.01|||||||t-test, 2 sided||||
1696317|NCT01035606|3118606|Superiority||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1696342|NCT01034397|3118716|Superiority or Other|||||||0.118|||||||t-test, 1 sided||||
1696343|NCT01034397|3118718|Superiority or Other|||||||0.002|||||||t-test, 1 sided||||
1696344|NCT01034397|3118720|Superiority or Other|||||||0.001|||||||t-test, 1 sided||||
1696318|NCT01035346|3118611|Superiority or Other||Mean Difference (Final Values)|0.53||||0.21|2-Sided|95.0|-0.12|1.18||p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.|
1696319|NCT01035346|3118612|Superiority or Other||Mean Difference (Final Values)|0.48||||0.324|2-Sided|95.0|-0.3|1.27||p-value was calculated using CMH test with modified ridit scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||Treatment difference (Ibuprofen sodium-Placebo) and the associated CI were calculated based on the weighted Gamma statistic.|
1696320|NCT01035346|3118613|Superiority or Other||difference in proportion|11.11||||0.378|2-Sided|95.0|-10.67|32.89||p-value was calculated using CMH general association test using table scores. Statistical testing was done at 5% significance level (2-sided).|Cochran-Mantel-Haenszel|||8 hours: Treatment difference (Ibuprofen sodium-Placebo) and its associated CI were calculated based on Cochran-Mantel-Haenszel (CMH) adjusted proportion and the corresponding standard errors.|
1696321|NCT01035346|3118615|Superiority or Other||LS mean difference|0.31||||0.849|2-Sided|95.0|-3.98|4.61||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||8 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1696322|NCT01035346|3118615|Superiority or Other||LS mean difference|1.17||||0.388|2-Sided|95.0|-2.18|4.52||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||6 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1696323|NCT01035346|3118615|Superiority or Other||LS mean difference|1.87||||0.215|2-Sided|95.0|-1.66|5.41||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||4 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1696324|NCT01035346|3118615|Superiority or Other||LS mean difference|1.58||||0.161|2-Sided|95.0|-0.98|4.14||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||2 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1696325|NCT01035346|3118615|Superiority or Other||LS mean difference|1.31||||0.116|2-Sided|95.0|-0.51|3.12||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||1 hour: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1696326|NCT01035346|3118615|Superiority or Other||LS mean difference|0.18||||0.502|2-Sided|95.0|-0.5|0.87||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.5 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1696327|NCT01035346|3118615|Superiority or Other||LS mean difference|-0.15||||0.576|2-Sided|95.0|-0.84|0.54||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||0.25 hours: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1696328|NCT01035346|3118616|Superiority or Other||LS mean difference|8.96||||0.354|2-Sided|95.0|-14.78|32.69||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||STEMPD 0-8: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1696329|NCT01035346|3118616|Superiority or Other||LS mean difference|5.99||||0.171|2-Sided|95.0|-3.99|15.97||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||STEMPD 0-4: Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95% CI were calculated based on LS means from the ANOVA model.|
1696330|NCT01035346|3118617|Superiority or Other||Least-squares (LS) mean difference|8.33||||0.228|2-Sided|95.0|-7.94|24.6||p-value was calculated using ANOVA model with treatment and baseline temperature terms. Statistical testing was done at 5% significance level (2-sided).|ANOVA|||Treatment difference (Ibuprofen sodium-Placebo) and corresponding 95 percent (%) confidence interval (CI) were calculated based on Least-squares (LS) means from the Analysis of Variance (ANOVA) model.|
1696331|NCT01034631|3118681|Other|||||||0.6625|||||||Chi-squared||||
1696332|NCT01034540|3118700|Superiority or Other||||||=|0||||||P-value is for the treatment effect from the final ANOVA model for insulin secretion index.|ANOVA||||
1696333|NCT01034540|3118700|Superiority or Other||||||=|0|||||||ANOVA|P-value is for the treatment effect from the final ANOVA model for disposition index.|||
1696334|NCT01034540|3118701|Superiority or Other||||||=|0||||||Values were not normally distributed, thus analyses were performed on ranked values and medians (IQL) are presented.|ANOVA|P-value is for treatment effect from the final ANOVA model.||An evaluable sample of 19 subjects provided 80% power (5% alpha-level, 2-tailed) to detect a 2.1 unit difference between control and active in MISI, assuming a 3.0 unit standard deviation (SD). Repeated measures ANOVA was used to assess responses to treatment. Initial repeated measures models contained terms of treatment period, and sequence as fixed effects, with subject modeled as random effect; models were reduced until only significant terms or treatment remained.|
1696335|NCT01034462|3118703|Superiority or Other||Least squares mean difference|-2.632||||0.001|2-Sided|95.0|-4.193|-1.07|||Mixed Models Analysis|Mixed-effects model for repeated measures.|||
1696336|NCT01034462|3118704|Superiority or Other||Least squares mean difference|-3.095||||0.0051|2-Sided|95.0|-5.256|-0.935|||Mixed Models Analysis|Mixed-effects model for repeated measures.|||
1696337|NCT01034397|3118706|Superiority or Other|||||||0.051|||||||t-test, 1 sided||||
1696338|NCT01034397|3118708|Superiority or Other|||||||0.19|||||||t-test, 1 sided||||
1696339|NCT01034397|3118711|Superiority or Other|||||||1|||||||t-test, 1 sided||||
1696352|NCT01034397|3118738|Superiority or Other|||||||1||||||Percentage and absolute change in DCE-MRI EER (wrist); Placebo versus Tocilizumab|t-test, 1 sided||||
1696353|NCT01034397|3118741|Superiority or Other|||||||0.37||||||Absolute change in DCE-MRI EER (MCP); Placebo versus Tocilizumab|t-test, 1 sided||||
1696354|NCT01034397|3118742|Superiority or Other|||||||0.271||||||Percentage change in DCE-MRI EER (MCP); Placebo versus Tocilizumab|t-test, 1 sided||||
1696355|NCT01034397|3118745|Superiority or Other|||||||0.239||||||Absolute Change in DCE-MRI EER; Tocilizumab versus placebo.|t-test, 1 sided||||
1696356|NCT01034397|3118746|Superiority or Other|||||||0.114||||||Percentage change in DCE-MRI EER (global); Placebo versus Tocilizumab|t-test, 1 sided||||
1696357|NCT01034397|3118749|Superiority or Other|||||||0.337||||||Absolute Change in Bone edema; Tocilizumab versus placebo.|t-test, 1 sided||||
1696358|NCT01034397|3118750|Superiority or Other|||||||0.266||||||Percentage Change in Bone oedema; Tocilizumab versus placebo.|t-test, 1 sided||||
1696359|NCT01034397|3118753|Superiority or Other|||||||1||||||Percentage Change in Bone erosion; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided||||
1696360|NCT01034397|3118754|Superiority or Other|||||||1||||||Absolute Change in Bone erosion; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided||||
1696361|NCT01034397|3118756|Superiority or Other|||||||1||||||Change in Total synovitis; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided||||
1696362|NCT01034397|3118756|Superiority or Other|||||||0.065||||||Change in 2nd to 5th MCP; Tocilizumab versus placebo.|t-test, 1 sided||||
1696363|NCT01034397|3118756|Superiority or Other|||||||1||||||Change in Wrist region; Tocilizumab versus placebo. Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided||||
1696364|NCT01034397|3118759|Superiority or Other|||||||0.434||||||Absolute change in OMERACT RAMRIS global score; Placebo versus Tocilizumab|t-test, 1 sided||||
1696365|NCT01034397|3118760|Superiority or Other|||||||0.421||||||Percentage Change in OMERACT RAMRIS global score; Tocilizumab versus placebo.|t-test, 1 sided||||
1696366|NCT01034397|3118761|Superiority or Other|||||||1||||||Total synovitis score: Tocilizumab versus placebo; Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided||||
1696367|NCT01034397|3118761|Superiority or Other|||||||0.026||||||2nd and 5th MCP joints: Tocilizumab versus placebo|t-test, 1 sided||||
1696368|NCT01034397|3118761|Superiority or Other|||||||1||||||Wrist region: Tocilizumab versus placebo; Since one-sided t-test was used all effects in the opposite direction of what was predicted have a p-value=1.|t-test, 1 sided||||
1696369|NCT01034137|3118810|Superiority or Other||Risk Ratio (RR)|1.03||||0.616|2-Sided|95.0|0.915|1.16|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the CMH test taking into account the stratification factors used for randomization.|
1696370|NCT01034137|3118810|Superiority or Other||Risk Ratio (RR)|1.855|||<|0.001|2-Sided|95.0|1.481|2.323|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the CMH test taking into account the stratification factors used for randomization.|
1696371|NCT01034137|3118810|Superiority or Other||Risk Ratio (RR)|1.996|||<|0.001|2-Sided|95.0|1.589|2.506|||Cochran-Mantel-Haenszel|||The SRR was compared between the treatment groups by means of the Cochran-Mantel-Haenszel (CMH) test taking into account the stratification factors used for randomization.|
1696372|NCT01033942|3118813|Superiority or Other|||||||0.2301|||||||Fisher Exact||||
1696373|NCT01033942|3118814|Superiority or Other|||||||0.9771|||||||Fisher Exact||||
1696374|NCT01033942|3118815|Superiority or Other|||||||0.9881|||||||Fisher Exact||||
1696375|NCT01033942|3118816|Superiority or Other|||||||0.5778|||||||Fisher Exact||||
1696376|NCT01033942|3118817|Superiority or Other|||||||0.8582|||||||Fisher Exact||||
1696377|NCT01033942|3118818|Superiority or Other|||||||0.6434|||||||Fisher Exact||||
1696378|NCT01033942|3118819|Superiority or Other|||||||0.6267|||||||Fisher Exact||||
1696379|NCT01033942|3118820|Superiority or Other|||||||0.9363|||||||Fisher Exact||||
1696380|NCT01033942|3118821|Superiority or Other|||||||0.7374|||||||Fisher Exact||||
1696381|NCT01033942|3118822|Superiority or Other|||||||0.3791|||||||Fisher Exact||||
1696382|NCT01033942|3118823|Superiority or Other|||||||0.4686|||||||Fisher Exact||||
1696383|NCT01033942|3118824|Superiority or Other|||||||0.47|||||||Fisher Exact||||
1696384|NCT01033942|3118825|Superiority or Other|||||||0.1524|||||||Fisher Exact||||
1696385|NCT01033942|3118826|Superiority or Other|||||||0.5369|||||||Fisher Exact||||
1696386|NCT01033942|3118827|Superiority or Other|||||||0.2187|||||||Fisher Exact||||
1696387|NCT01033942|3118828|Superiority or Other|||||||0.4207|||||||Fisher Exact||||
1696388|NCT01033942|3118829|Superiority or Other|||||||0.0484|||||||Fisher Exact||||
1696389|NCT01033942|3118830|Superiority or Other|||||||0.8351|||||||Fisher Exact||||
1696390|NCT01033942|3118831|Superiority or Other|||||||0.6202|||||||Fisher Exact||||
1696391|NCT01033942|3118832|Superiority or Other|||||||0.8243|||||||Fisher Exact||||
1696392|NCT01033942|3118833|Superiority or Other|||||||0.1203|||||||Fisher Exact||||
1696393|NCT01033942|3118834|Superiority or Other|||||||0.1747|||||||Fisher Exact||||
1696394|NCT01033942|3118835|Superiority or Other|||||||0.1733|||||||Fisher Exact||||
1696395|NCT01033942|3118836|Superiority or Other|||||||0.5317|||||||Fisher Exact||||
1696396|NCT01033942|3118837|Superiority or Other|||||||0.2146|||||||Fisher Exact||||
1696397|NCT01033942|3118838|Superiority or Other|||||||0.1934|||||||Fisher Exact||||
1696398|NCT01033942|3118839|Superiority or Other|||||||0.0087|||||||Fisher Exact||||
1696399|NCT01033942|3118840|Superiority or Other|||||||0.5826|||||||Fisher Exact||||
1696400|NCT01033942|3118841|Superiority or Other|||||||0.0948|||||||Fisher Exact||||
1696420|NCT01033942|3118861|Superiority or Other|||||||0.2342|||||||Chi-squared||||
1696421|NCT01033942|3118862|Superiority or Other|||||||0.2685|||||||Chi-squared||||
1696422|NCT01033942|3118863|Superiority or Other|||||||0.2829|||||||Chi-squared||||
1696423|NCT01033942|3118864|Superiority or Other|||||||0.1912|||||||Chi-squared||||
1696424|NCT01033942|3118865|Superiority or Other|||||||0.0729|||||||Chi-squared||||
1696425|NCT01033942|3118866|Superiority or Other|||||||0.1661|||||||Chi-squared||||
1696426|NCT01033942|3118867|Superiority or Other|||||||0.5133|||||||Chi-squared||||
1696427|NCT01033942|3118868|Superiority or Other|||||||0.3846|||||||Chi-squared||||
1696428|NCT01033942|3118869|Superiority or Other|||||||0.2559|||||||Chi-squared||||
1696429|NCT01033942|3118870|Superiority or Other|||||||0.5265|||||||Chi-squared||||
1696430|NCT01033942|3118871|Superiority or Other|||||||0.2|||||||Chi-squared||||
1696431|NCT01033942|3118872|Superiority or Other|||||||0.6153|||||||Chi-squared||||
1696432|NCT01033942|3118873|Superiority or Other|||||||0.7434|||||||Chi-squared||||
1696433|NCT01033942|3118881|Superiority or Other|||||||0.8505|||||||Chi-squared||||
1696434|NCT01033942|3118882|Superiority or Other|||||||0.6462|||||||Fisher Exact||||
1696435|NCT01033942|3118883|Superiority or Other|||||||0.4003|||||||Fisher Exact||||
1696436|NCT01033942|3118884|Superiority or Other|||||||0.9999|||||||Fisher Exact||||
1696437|NCT01033942|3118885|Superiority or Other|||||||0.9999|||||||Fisher Exact||||
1696438|NCT01033942|3118886|Superiority or Other|||||||0.9999|||||||Fisher Exact||||
1696439|NCT01033942|3118887|Superiority or Other|||||||0.8934|||||||Chi-squared||||
1696440|NCT01033942|3118888|Superiority or Other|||||||0.9999|||||||Fisher Exact||||
1696441|NCT01033942|3118889|Superiority or Other|||||||0.9999|||||||Fisher Exact||||
1696442|NCT01033942|3118890|Superiority or Other|||||||0.7007|||||||Fisher Exact||||
1696443|NCT01033942|3118891|Superiority or Other|||||||0.9999|||||||Fisher Exact||||
1696444|NCT01033942|3118892|Superiority or Other|||||||0.9999|||||||Fisher Exact||||
1696445|NCT01033942|3118893|Superiority or Other|||||||0.9999|||||||Fisher Exact||||
1696446|NCT01033942|3118894|Superiority or Other|||||||0.4089||||||Not all subjects answered every question.|Fisher Exact||||
1696447|NCT01033942|3118895|Superiority or Other|||||||0.2366||||||Not all participants answered every question|Fisher Exact||||
1696448|NCT01033942|3118896|Superiority or Other|||||||0.185||||||Not all participants answered every question|Fisher Exact||||
1696449|NCT01033942|3118897|Superiority or Other|||||||0.2809||||||Not all participants answered every question|Fisher Exact||||
1696450|NCT01033942|3118898|Superiority or Other|||||||0.2151||||||Not all participants answered every question|Fisher Exact||||
1696451|NCT01033942|3118899|Superiority or Other|||||||0.1538||||||Not all participants answered every question|Fisher Exact||||
1696452|NCT01033942|3118900|Superiority or Other|||||||0.224||||||Not all participants answered every question|Fisher Exact||||
1696453|NCT01033942|3118901|Superiority or Other|||||||0.1908|||||||Fisher Exact||||
1696454|NCT01033942|3118902|Superiority or Other|||||||0.1886||||||Not all participants answered every question|Fisher Exact||||
1696455|NCT01033942|3118903|Superiority or Other|||||||0.2297||||||Not all participants answered every question|Fisher Exact||||
1696456|NCT01033942|3118904|Superiority or Other|||||||0.9999||||||Not all participants answered every question|Fisher Exact||||
1696457|NCT01033942|3118905|Superiority or Other|||||||0.4655||||||Not all participants answered every question|Fisher Exact||||
1696458|NCT01033942|3118906|Superiority or Other|||||||0.6921||||||Not all subjects answered every question.|Fisher Exact||||
1696459|NCT01033942|3118907|Superiority or Other|||||||0.8722|||||||Fisher Exact||||
1696460|NCT01033942|3118908|Superiority or Other|||||||0.6983||||||The p-value is for the difference in treatment (TX) groups overall. The interaction between TX group and study time that tests whether the TX groups differed over time could not be tested due to small no. of subjects that missed visits during study.|Chi-squared||||
1696461|NCT01033864|3118910|Superiority or Other|||||||0.0002|||||||Wilcoxon (Mann-Whitney)||||
1696462|NCT01033864|3118911|Superiority or Other|||||||0.0074|||||||Wilcoxon (Mann-Whitney)||||
1696463|NCT01033864|3118912|Superiority or Other|||||||0.3401|||||||Wilcoxon (Mann-Whitney)||||
1696464|NCT01033864|3118913|Superiority or Other|||||||0.0106|||||||Wilcoxon (Mann-Whitney)||||
1696465|NCT01033864|3118914|Superiority or Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)||||
1696466|NCT01033864|3118915|Superiority or Other|||||||0.0455|||||||Wilcoxon (Mann-Whitney)||||
1696467|NCT01033864|3118916|Superiority or Other|||||||0.4417|||||||Wilcoxon (Mann-Whitney)||||
1696468|NCT01033864|3118917|Superiority or Other|||||||0.2548|||||||Wilcoxon (Mann-Whitney)||||
1696469|NCT01033864|3118918|Superiority or Other|||||||0.8055|||||||Wilcoxon (Mann-Whitney)||||
1696470|NCT01033851|3118919|Superiority or Other|||||||0.0366|||||||ANOVA|||A repeated measure ANOVA, with time as the repeated measure, treatment arm as between-subjects factor and CGI-S score as the dependent variable, found a main effect of time (F(1,84)=62.19, p<0.001) and a significant treatment arm X time interaction (F(1,84)=4.51, p=0.0366).|
1696471|NCT01033825|3118936|Non-Inferiority or Equivalence|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is <Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide nasal spray 200 μg to placebo nasal spray 46 evaluable (per protocol) subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL|Mean Difference (Final Values)|10.4|||>|0.05|2-Sided|95.0|-4.7|25.5|||ANCOVA|||Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.|
1696492|NCT01033487|3118997|Superiority or Other||Mean Difference (Final Values)|0.0927|Standard Error of the Mean|0.0277|||1-Sided|90.0|0.056|||||||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|
1696472|NCT01033825|3118936|Non-Inferiority or Equivalence|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is <Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.|Mean Difference (Final Values)|-2.4|||>|0.025|2-Sided|95.0|-15.1|10.2|||ANCOVA|||Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.|
1696473|NCT01033825|3118936|Non-Inferiority or Equivalence|Non-inferiority will be demonstrated if the 95% CI upper bound for the difference between ciclesonide and placebo with placebo dexamethasone (placebo minus ciclesonide) is <Margin. In order to have 90% power to demonstrate non-inferiority of ciclesonide 320 μg to HFA placebo, 46 evaluable subjects per group are needed using a 1-sided alpha level of 0.025, a standard deviation of 55 μg h/dL, a non-inferiority margin of 38 μh /dL, assuming no true difference exists.|Mean Difference (Final Values)|-0.5|||>|0.05|2-Sided|95.0|-13.9|13.0|||ANCOVA||Null Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)>=38 Alternative Hypothesis: the difference in serum cortisol levels between placebo and active (placebo-active)<38|Standard bioequivalence bounds of a 20% difference based on the clinical judgment was used to determine the delta.|
1696474|NCT01033487|3118987|Superiority or Other||Mean Difference (Final Values)|0.0166|Standard Error of the Mean|0.213|||1-Sided|90.0|-0.011|||||||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696475|NCT01033487|3118987|Superiority or Other||Mean Difference (Final Values)|-0.0108|Standard Error of the Mean|0.0213|||1-Sided|90.0|-0.0383|||||||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696476|NCT01033487|3118987|Superiority or Other||Mean Difference (Final Values)|-0.0674|Standard Error of the Mean|0.0211|||1-Sided|90.0|-0.0946|||||||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696477|NCT01033487|3118987|Superiority or Other||Mean Difference (Final Values)|0.1526|Standard Error of the Mean|0.0212|||1-Sided|90.0|0.1252|||||||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696478|NCT01033487|3118987|Superiority or Other||Mean Difference (Final Values)|0.1692|Standard Error of the Mean|0.0216|||1-Sided|90.0|0.1413|||||||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696479|NCT01033487|3118987|Superiority or Other||Mean Difference (Final Values)|0.1418|Standard Error of the Mean|0.0219|||1-Sided|90.0|0.1136|||||||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696480|NCT01033487|3118987|Superiority or Other||Mean Difference (Final Values)|0.0852|Standard Error of the Mean|0.0214|||1-Sided|90.0|0.0576|||||||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696481|NCT01033487|3118988|Superiority or Other||Mean Difference (Final Values)|0.0381|Standard Error of the Mean|0.0242|||1-Sided|90.0|0.0068|||||||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696482|NCT01033487|3118988|Superiority or Other||Mean Difference (Final Values)|0.022|Standard Deviation|0.0238|||1-Sided|90.0|-0.0088|||||||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696483|NCT01033487|3118988|Superiority or Other||Mean Difference (Final Values)|-0.0539|Standard Error of the Mean|0.0239|||1-Sided|90.0|-0.0849|||||||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696484|NCT01033487|3118988|Superiority or Other||Mean Difference (Final Values)|0.1528|Standard Error of the Mean|0.0237|||1-Sided|90.0|0.1222|||||||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696485|NCT01033487|3118988|Superiority or Other||Mean Difference (Final Values)|0.1909|Standard Error of the Mean|0.0243|||1-Sided|90.0|0.1594|||||||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696486|NCT01033487|3118988|Superiority or Other||Mean Difference (Final Values)|0.1748|Standard Error of the Mean|0.0245|||1-Sided|90.0|0.1431|||||||Mixed effects ANOVA was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696487|NCT01033487|3118988|Superiority or Other||Mean Difference (Final Values)|0.0989|Standard Error of the Mean|0.242|||1-Sided|90.0|0.0676|||||||Mixed effects analysis of variance (ANOVA) was used with sequence, period and baseline covariate as fixed effects, and participant within sequence as a random effect. Lower (1-sided) 90% CI was reported.|
1696488|NCT01033487|3118997|Superiority or Other||Mean Difference (Final Values)|0.0315|Standard Error of the Mean|0.0294|||1-Sided|80.0|0.0062|||||||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|
1696489|NCT01033487|3118997|Superiority or Other||Mean Difference (Final Values)|0.0175|Standard Error of the Mean|0.0246|||1-Sided|80.0|-0.0037|||||||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|
1696490|NCT01033487|3118997|Superiority or Other||Mean Difference (Final Values)|-0.0105|Standard Error of the Mean|0.0309|||1-Sided|80.0|-0.0371|||||||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 80% CI was reported.|
1696491|NCT01033487|3118997|Superiority or Other||Mean Difference (Final Values)|0.0613|Standard Error of the Mean|0.03|||1-Sided|90.0|0.0215|||||||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|
1698315|NCT01016977|3121120|Superiority or Other|||||||0.7705||||||Week 2|ANCOVA||||
1696493|NCT01033487|3118997|Superiority or Other||Mean Difference (Final Values)|0.0788|Standard Error of the Mean|0.027|||1-Sided|90.0|0.0431|||||||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90% CI was reported.|
1696494|NCT01033487|3118997|Superiority or Other||Mean Difference (Final Values)|0.0507|Standard Error of the Mean|0.0339|||1-Sided|90.0|0.0059|||||||Emax model was used with sequence, period and baseline covariate as fixed effects. Lower (1-sided) 90 percent (%) confidence interval (CI) was reported.|
1696495|NCT01033136|3119010|Other|||||||0.68||||||The threshold for statistical significance is p <.05 and is not adjusted for multiple comparisons.|Mixed Models Analysis|Degrees of freedom: 2, 54||Longitudinal analysis of PDSS scores|
1696496|NCT01033136|3119011|Equivalence|To test if MCET is equivalent to CPT in decreasing PTSD symptoms, we test the equivalence of the proportion of patients whose CAPS scores decrease by 10 from baseline, by testing whether the difference in proportions between the 2 interventions ≤ to the equivalence margin δb of .20. Results are reported based on 3-month follow-up data.||||||0.3||||||The threshold for statistical significance is p <.05 and is not adjusted for multiple comparisons.|Fisher Exact||||
1696497|NCT01033071|3119024|Superiority or Other||Mean Difference (Final Values)|-8.8|||<|0.001|2-Sided|95.0|-11.0|-6.7||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.|
1696498|NCT01033071|3119024|Superiority or Other||Mean Difference (Final Values)|-6.4|||<|0.001|2-Sided|95.0|-8.5|-4.3||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.|
1696499|NCT01033071|3119026|Superiority or Other||Mean Difference (Final Values)|-9.0|||<|0.001|2-Sided|95.0|-11.5|-6.6||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.|
1696500|NCT01033071|3119026|Superiority or Other||Mean Difference (Final Values)|-7.0|||<|0.001|2-Sided|95.0|-9.4|-4.7||Tested at the 0.05 significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.|
1696501|NCT01033071|3119029|Superiority or Other||Mean Difference (Final Values)|-6.9|||<|0.001|2-Sided|95.0|-9.2|-4.6||Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of “all treatment groups equal” first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate.|
1696502|NCT01033071|3119029|Superiority or Other||Mean Difference (Final Values)|-5.3|||<|0.001||95.0|-7.6|-3.1||Overall Type 1 error rate of 0.05 controlled using 'Closed Testing' principle (hypothesis of “all treatment groups equal” first tested at 0.05 significance level; upon rejection of this hypothesis, pairwise comparison was tested at the 0.05 level.|ANCOVA|||Analysis of covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate.|
1696503|NCT01032889|3119046|Superiority or Other||Difference from placebo|-1.7|||<|0.001|2-Sided|95.0|-2.46|-0.85|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.|||
1696504|NCT01032889|3119046|Superiority or Other||Difference from placebo|-1.5|||<|0.001|2-Sided|95.0|-2.32|-0.69|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.|||
1696505|NCT01032889|3119047|Superiority or Other||Difference from placebo|-110.0||||0.803|2-Sided|95.0|-1013.0|792.6|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.|||
1696506|NCT01032889|3119047|Superiority or Other||Difference from placebo|-606.0||||0.166|2-Sided|95.0|-1482.0|269.3|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.|||
1696507|NCT01032889|3119048|Superiority or Other||Difference from placebo|-2.5|||<|0.001|2-Sided|95.0|-3.48|-1.48|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.|
1696508|NCT01032889|3119048|Superiority or Other||Difference from placebo|-1.4|||<|0.005|2-Sided|95.0|-2.44|-0.46|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.|
1696509|NCT01032889|3119049|Superiority or Other||Difference from placebo|-0.6|||<|0.001|2-Sided|95.0|-0.91|-0.3|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.|
1696510|NCT01032889|3119049|Superiority or Other||Difference from placebo|-0.2|||<|0.117|2-Sided|95.0|-0.55|0.06|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.|
1696511|NCT01032889|3119050|Superiority or Other||Difference from placebo|-0.5||||0.003|2-Sided|95.0|-0.77|-0.16|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.|
1696512|NCT01032889|3119050|Superiority or Other||Difference from placebo|-0.3||||0.052|2-Sided|95.0|-0.61|0.0|||ANCOVA|The ANCOVA model included terms for treatment group and the baseline covariate.||There was no formal hypothesis testing and no adjustments for multiple comparisons.|
1696513|NCT01032733|3119072|Superiority or Other||Mean Difference (Net)|1.0|Standard Deviation|1.0|<|0.05|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1696514|NCT01032733|3119073|Superiority or Other||Mean Difference (Net)|5.0|Standard Deviation|15.0|<|0.05|2-Sided|95.0|||||ANCOVA||||
1696515|NCT01032733|3119074|Superiority or Other||Mean Difference (Net)|2.0|Standard Deviation|2.0|<|0.05|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1696516|NCT01032733|3119075|Superiority or Other||Mean Difference (Net)|5.0|Standard Deviation|5.0|<|0.05|2-Sided|95.0|||||ANCOVA||||
1696517|NCT01032733|3119076|Superiority or Other||Median Difference (Net)|0.06|Standard Deviation|0.5|<|0.05|1-Sided|95.0|||||ANCOVA|||This trial represented a pilot study, which was designed to demonstrate the feasibility, acceptability, and efficacy of the intervention; therefore, a power analysis was not conducted. The statistical analyses consisted of descriptive and intent-to-treat (ITT) modeling procedures.|
1696518|NCT01032629|3119080|Other||Difference of Least Square Mean|0.04|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.023|0.094|||||||
1696519|NCT01032629|3119080|Other||Difference of Least Square Mean|0.02|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.04|0.076|||||||
1696520|NCT01032629|3119081|Other||Difference of Least Square Mean|0.16|Standard Error of the Mean|0.032|||2-Sided|95.0|0.102|0.226||||||Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here.|
1696521|NCT01032629|3119081|Other||Difference of Least Square Mean|0.11|Standard Error of the Mean|0.032|||2-Sided|95.0|0.046|0.17||||||Statistical analysis (LDL-C) Comparison for canagliflozin versus placebo is reported here.|
1696522|NCT01032629|3119081|Other||Difference of Least Square Mean|0.06|Standard Error of the Mean|0.009|||2-Sided|95.0|0.04|0.075||||||Statistical analysis (HDL-C) Comparison for canagliflozin versus placebo is reported here.|
1696523|NCT01032629|3119081|Other||Difference of Least Square Mean|0.05|Standard Error of the Mean|0.009|||2-Sided|95.0|0.031|0.065||||||Statistical analysis (HDL-C)|
1696524|NCT01032629|3119081|Other||Difference of Least Square Mean|0.23|Standard Error of the Mean|0.039|||2-Sided|95.0|0.152|0.307||||||Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here.|
1696525|NCT01032629|3119081|Other||Difference of Least Square Mean|0.18|Standard Error of the Mean|0.039|||2-Sided|95.0|0.105|0.259||||||Statistical analysis (Cholesterol) Comparison for canagliflozin versus placebo is reported here.|
1696526|NCT01032629|3119082|Other||Hodges-Lehman Estimate|0.02|||||2-Sided|95.0|-0.03|0.08||||||Comparison for canagliflozin versus placebo is reported here.|
1696527|NCT01032629|3119082|Other||Hodges-Lehman Estimate|0.02|||||2-Sided|95.0|-0.04|0.07||||||Comparison for canagliflozin versus placebo is reported here.|
1696528|NCT01032629|3119083|Other||Difference of Least Square Mean|-1.63|Standard Error of the Mean|0.316|||2-Sided|95.0|-2.245|-1.007||||||Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here.|
1696529|NCT01032629|3119083|Other||Difference of Least Square Mean|-0.82|Standard Error of the Mean|0.314|||2-Sided|95.0|-1.437|-0.205||||||Statistical analysis (Diastolic blood pressure) Comparison for canagliflozin versus placebo is reported here.|
1696530|NCT01032629|3119083|Other||Difference of Least Square Mean|-4.53|Standard Error of the Mean|0.534|||2-Sided|95.0|-5.579|-3.484||||||Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here.|
1696531|NCT01032629|3119083|Other||Difference of Least Square Mean|-2.96|Standard Error of the Mean|0.532|||2-Sided|95.0|-3.998|-1.914||||||Statistical analysis (Systolic blood pressure) Comparison for canagliflozin versus placebo is reported here.|
1696532|NCT01032629|3119084|Other||Difference of Least Square Mean|-3.61|Standard Error of the Mean|0.261|||2-Sided|95.0|-4.125|-3.103||||||Comparison for canagliflozin versus placebo is reported here.|
1696533|NCT01032629|3119084|Other||Difference of Least Square Mean|-2.96|Standard Error of the Mean|0.26||||95.0|-3.472|-2.454||||||Comparison for canagliflozin versus placebo is reported here.|
1696534|NCT01032629|3119085|Other||Difference of Least Square Mean|-0.73|Standard Error of the Mean|0.108|||2-Sided|95.0|-0.945|-0.523||||||Comparison for canagliflozin versus placebo is reported here.|
1696535|NCT01032629|3119085|Other||Difference of Least Square Mean|-0.58|Standard Error of the Mean|0.107|||2-Sided|95.0|-0.794|-0.374||||||Comparison for canagliflozin versus placebo is reported here.|
1696536|NCT01032629|3119086|Other||Difference of Least Square Mean|-0.32|Standard Error of the Mean|0.046|||2-Sided|95.0|-0.405|-0.227||||||Comparison for canagliflozin versus placebo is reported here.|
1696537|NCT01032629|3119086|Other||Difference of Least Square Mean|-0.27|Standard Error of the Mean|0.045|||2-Sided|95.0|-0.355|-0.177||||||Comparison for canagliflozin versus placebo is reported here.|
1696538|NCT01032629|3119087|Other||Difference of Least Square Mean|1.24|Standard Error of the Mean|0.553|||2-Sided|95.0|0.16|2.328||||||Comparison for canagliflozin versus placebo is reported here.|
1696539|NCT01032629|3119087|Other||Difference of Least Square Mean|1.68|Standard Error of the Mean|0.55|||2-Sided|95.0|0.599|2.755||||||Comparison for canagliflozin versus placebo is reported here.|
1696540|NCT01032629|3119088|Other||Geometric mean ratio|0.84|||||2-Sided|95.0|0.77|0.91||||||Comparison for canagliflozin versus placebo is reported here.|
1696541|NCT01032629|3119088|Other||Geometric mean ratio|0.87|||||2-Sided|95.0|0.8|0.94||||||Comparison for canagliflozin versus placebo is reported here.|
1696542|NCT01032629|3119089|Other||Difference of Least Square Mean|0.33|Standard Error of the Mean|0.206|||2-Sided|95.0|-0.079|0.731||||||Comparison for canagliflozin versus placebo is reported here.|
1696543|NCT01032629|3119089|Other||Difference of Least Square Mean|-0.03|Standard Error of the Mean|0.205|||2-Sided|95.0|-0.429|0.374||||||Comparison for canagliflozin versus placebo is reported here.|
1696544|NCT01032629|3119090|Superiority||Odds Ratio (OR)|0.71|||||2-Sided|95.0|0.58|0.85||||||Comparison for canagliflozin versus placebo is reported here.|
1696545|NCT01032629|3119090|Superiority||Odds Ratio (OR)|0.8|||||2-Sided|95.0|0.67|0.97||||||Comparison for canagliflozin versus placebo is reported here.|
1696546|NCT01032629|3119091|Superiority||Difference of Least Square Mean|4.07|Standard Error of the Mean|2.261|=|0|2-Sided|95.0|-0.368|8.504|||ANCOVA|||Comparison for canagliflozin versus placebo is reported here.|
1696547|NCT01032629|3119091|Superiority||Difference of Least Square Mean|2.79|Standard Error of the Mean|2.224|=|0|2-Sided|95.0|-1.571|7.154|||ANCOVA|||Comparison for canagliflozin versus placebo is reported here.|
1696548|NCT01032629|3119092|Superiority||Hazard Ratio (HR)|0.88||||0.112|2-Sided|95.0|0.75|1.03|||Cox proportional hazard method|||Comparison for canagliflozin versus placebo is reported here.|
1696549|NCT01032629|3119092|Superiority||Hazard Ratio (HR)|0.83|||=|0|2-Sided|95.0|0.68|1.0|||Cox proportional hazard model|||Comparison for canagliflozin versus placebo is reported here.|
1696550|NCT01032629|3119092|Superiority||Hazard Ratio (HR)|0.93|||=|0|2-Sided|95.0|0.78|1.12|||Cox proportional hazard model|||Comparison for canagliflozin versus placebo is reported here.|
1696551|NCT01032603|3119093|Superiority||Difference in percentage of participants|12.0|||||2-Sided|95.0|-1.0|25.0||||||The proportion of participants with suboptimal surgical outcome at 3 years was compared between treatment groups using Barnard’s exact test, and an exact 95% CI on the treatment-group difference was calculated using Farrington-Manning scores.|
1696552|NCT01032603|3119094|Superiority||Difference in percentage of participants|-15.0|||||2-Sided|95.0|-30.0|-0.0003||||||All treatment-group differences were calculated as the BLRc group minus the R&R group. A treatment-group difference and a corresponding 95% confidence interval were calculated.|
1696659|NCT01031004|3119328|Superiority or Other|||||||0.1069|||||||Fisher Exact|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.|
1696553|NCT01032603|3119095|Superiority||Difference in percentage|5.0|||||2-Sided|95.0|-2.0|13.0||||||"The cumulative proportion of participants with re-operation by 3 years was obtained using the Kaplan-Meier (K-M) method.~A treatment-group difference and a corresponding 95% confidence interval were calculated.~Treatment-group differences were calculated as BLR minus RR."|
1696554|NCT01032603|3119096|Superiority|||||||0.64||||||Parent Surgical|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.|
1696555|NCT01032603|3119096|Superiority|||||||0.68||||||Parent Function|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.|
1696556|NCT01032603|3119096|Superiority|||||||0.42||||||Parent Psychosocial|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.|
1696557|NCT01032603|3119096|Superiority|||||||0.51||||||Parent Proxy IXTQ|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.|
1696558|NCT01032603|3119096|Superiority|||||||0.77||||||Child 8 to 13 years old|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores9, 10 at 3 years were compared between treatment groups using the Wilcoxon rank sum test.|
1696559|NCT01032603|3119096|Superiority|||||||0.3||||||Child 5 to 7 years old|Wilcoxon (Mann-Whitney)|||For the each of the two age-specific versions of the child IXTQ, the proxy questionnaire, and for each of the three parent questionnaire subscales, mean Rasch-based HRQOL scores at 3 years were compared between treatment groups using the Wilcoxon rank sum test.|
1696560|NCT01032603|3119098|Superiority|||||||0.82|||||||ANOVA|||3-year stereoacuity outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.|
1696561|NCT01032603|3119101|Superiority|||||||0.93|||||||ANOVA|||3-year stereoacuity outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.|
1696562|NCT01032603|3119104|Superiority|||||||0.38|||||||ANOVA|||3-year PACT outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.|
1696563|NCT01032603|3119107|Superiority|||||||0.21|||||||ANOVA|||3-year PACT outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value.|
1696564|NCT01032603|3119110|Superiority|||||||0.64|||||||ANOVA|||3-year control outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year near control will adjust for baseline near control).|
1696565|NCT01032603|3119113|Superiority|||||||0.44|||||||ANOVA|||3-year control outcomes were analyzed as continuous variables and compared between treatment groups using analysis of covariance (ANOVA) models that adjust for the corresponding baseline value (e.g. ANCOVA model of 3-year distance control will adjust for baseline distance control).|
1696566|NCT01032603|3119115|Superiority||Difference in percentage of participants|4.0||||0.36|2-Sided|95.0|-5.0|14.0|||Z test||Proportion of participants meeting criteria by 3 yrs was obtained by KM method. BLR group=14%, RR group=10%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.||
1696567|NCT01032603|3119116|Superiority||Difference in percentage of participants|-7.0||||0.06|2-Sided|95.0|-14.0|0.23|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=3%, RR group=10%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.||
1696568|NCT01032603|3119117|Superiority||Difference in percentage of participants|8.0||||0.25|2-Sided|95.0|-6.0|21.0|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=34%, RR group=26%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.||
1696569|NCT01032603|3119118|Superiority||Difference in percentage of participants|9.0||||0.24|2-Sided|95.0|-6.0|23.0|||Z test||Proportion of participants meeting criteria was obtained by Kaplan-Meier method. BLR group=46%, RR group=37%. Probability was compared b/w groups using Z test. A group difference and 95% CI were calculated. Positive differences favor the RR group.||
1696570|NCT01032330|3119136|Other|||||||0.09|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696571|NCT01032330|3119136|Other|||||||0.6|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696572|NCT01032330|3119137|Other|||||||0.1|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696573|NCT01032330|3119137|Other|||||||0.11|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696574|NCT01032330|3119138|Other|||||||0.01|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1698316|NCT01016977|3121120|Superiority or Other|||||||0.7546||||||Week 1|ANCOVA||||
1696575|NCT01032330|3119138|Other|||||||0.002|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696576|NCT01032330|3119139|Other|||||||0.02|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696577|NCT01032330|3119139|Other|||||||0.012|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696578|NCT01032330|3119140|Other|||||||0.61|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696579|NCT01032330|3119140|Other|||||||0.42|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696580|NCT01032330|3119141|Other|||||||0.26|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696581|NCT01032330|3119141|Other|||||||0.013|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696582|NCT01032330|3119142|Other|||||||0.33|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696583|NCT01032330|3119142|Other||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 Years in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696584|NCT01032330|3119143|Other|||||||0.02|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Younger cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696585|NCT01032330|3119143|Other|||||||0.09|||||||ANCOVA|||P-value for the change between baseline and 6 months in the Older cohort. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696586|NCT01032330|3119144|Other||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696587|NCT01032330|3119145|Other|||||||0.38|||||||ANCOVA|||Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome; P values for comparisons of binary outcomes are from logistic regression models adjusting for the baseline level of the outcome.|
1696588|NCT01032330|3119146|Other||||||<|0.001|||||||ANCOVA|||P-value for the change between baseline and 3 years. Two-sided p values for comparisons of continuous outcomes are from analysis of covariance models adjusting for the baseline level of the outcome.|
1696589|NCT01032330|3119148|Superiority||Risk Difference (RD)|0.024||||0.27|2-Sided|95.0|-0.038|0.094|||One-sided Barnard's Test||||
1696590|NCT01032330|3119149|Other||cumulative probability|0.15|||||2-Sided|95.0|0.1|0.22|||||Kaplan-Meier estimate of cumulative probability of deterioration by 3 years||
1696591|NCT01032330|3119150|Superiority||Risk Difference (RD)|0.054||||0.004|1-Sided|95.0|0.02||||One-sided Barnard's Test||||
1696592|NCT01032265|3119159|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||analysis between groups|
1696593|NCT01032265|3119160|Superiority or Other|||||||0.23|||||||negative binomial regression|||analysis between groups|
1696594|NCT01032265|3119161|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||analysis between groups|
1696595|NCT01032265|3119162|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||analysis between groups|
1696596|NCT01032265|3119163|Superiority or Other|||||||0.3|||||||Mixed Models Analysis|||analysis between groups|
1696597|NCT01032265|3119164|Superiority or Other|||||||0.52|||||||Mixed Models Analysis|||analysis between groups|
1696598|NCT01032265|3119165|Superiority or Other|||||||0.27|||||||Mixed Models Analysis|||analysis between groups|
1696599|NCT01032239|3119168|Superiority|||||||0.2105|||||||t-test, 2 sided||||
1696600|NCT01032239|3119169|Superiority|||||||0.6824|||||||t-test, 2 sided|||MCS|
1696601|NCT01032239|3119169|Superiority|||||||0.1068|||||||t-test, 2 sided|||PCS|
1696602|NCT01032239|3119170|Superiority|||||||0.3807|||||||t-test, 2 sided|||VAS|
1696603|NCT01032239|3119170|Superiority|||||||0.0197|||||||Wilcoxon (Mann-Whitney)|||Utility Score|
1696604|NCT01032239|3119171|Superiority|||||||0.7661|||||||Fisher Exact||||
1696605|NCT01032239|3119172|Superiority|||||||0.2427|||||||Wilcoxon (Mann-Whitney)|||Worst Pain|
1696606|NCT01032239|3119172|Superiority|||||||0.0136|||||||Wilcoxon (Mann-Whitney)|||Least Pain|
1696607|NCT01032239|3119172|Superiority|||||||0.038|||||||Wilcoxon (Mann-Whitney)|||Actual Pain|
1696608|NCT01032239|3119173|Superiority|||||||0.3676|||||||Cochran-Mantel-Haenszel||||
1696609|NCT01032239|3119174|Superiority|||||||0.6256|||||||Wilcoxon (Mann-Whitney)||||
1696610|NCT01032239|3119175|Superiority|||||||0.054|||||||Wilcoxon (Mann-Whitney)||||
1696611|NCT01032239|3119176|Superiority||Hodges–Lehmann|-0.6||||0.0042|2-Sided|95.0|-1.0|-0.2|||Wilcoxon (Mann-Whitney)||||
1696612|NCT01032239|3119177|Superiority||Hodges-Lehmann|-0.667||||0.014|2-Sided|95.1|-1.0|-0.1667|||Wilcoxon (Mann-Whitney)|||To test the null hypothesis the sample size needed was 44 evaluable patient (22 per arm) with a power of 80 %.|
1696613|NCT01032174|3119183|Superiority or Other|||||||0.0682||||||The logistic regression model contained terms for treatment, gender and age.|Regression, Logistic||||
1696614|NCT01032174|3119184|Superiority or Other||Difference of Least Square Mean|1.06|Standard Error of the Mean|0.55||0.0568|2-Sided|95.0|-0.03|2.15||The analysis of covariance (ANCOVA) model contained terms for treatment, gender, age and Body Mass Index (BMI).|ANCOVA|Least square mean was adjusted for gender, age and BMI.|||
1696615|NCT01032174|3119185|Superiority or Other||||||<|0.0001||||||The logistic regression model contained terms for treatment, gender and age.|Regression, Logistic||||
1696616|NCT01032135|3119186|Other||Odds Ratio (OR)|0.6||||0.42|2-Sided|95.0|-0.85|2.04|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696617|NCT01032135|3119186|Other||Odds Ratio (OR)|-0.84||||0.16|2-Sided|95.0|-1.98|0.3|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696618|NCT01032135|3119186|Other||Odds Ratio (OR)|-0.13||||0.75|2-Sided|95.0|-0.94|0.6|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696619|NCT01032135|3119189|Other||Odds Ratio (OR)|1.48||||0.36|2-Sided|95.0|0.64|3.4|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696620|NCT01032135|3119189|Other||Odds Ratio (OR)|0.83||||0.71|2-Sided|95.0|0.33|2.12|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696621|NCT01032135|3119189|Other||Odds Ratio (OR)|0.66||||0.13|2-Sided|95.0|0.38|1.14|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696622|NCT01032135|3119193|Other||Odds Ratio (OR)|0.02||||0.1|2-Sided|95.0|-1.1|1.14|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696623|NCT01032135|3119193|Other||Odds Ratio (OR)|-1.09||||0.003|2-Sided|95.0|-1.8|-0.39|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696624|NCT01032135|3119198|Other||Odds Ratio (OR)|1.43||||0.45|2-Sided|95.0|0.58|3.54|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696625|NCT01032135|3119198|Other||Odds Ratio (OR)|0.67||||0.36|2-Sided|95.0|0.29|1.54|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696626|NCT01032135|3119198|Other||Odds Ratio (OR)|0.33||||0.0001|2-Sided|95.0|0.19|0.58|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696627|NCT01032135|3119203|Other||Odds Ratio (OR)|-0.34||||0.58|2-Sided|95.0|-1.52|0.85|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696628|NCT01032135|3119203|Other||Odds Ratio (OR)|-0.84||||0.23|2-Sided|95.0|-2.2|0.52|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696629|NCT01032135|3119203|Other||Odds Ratio (OR)|-1.08||||0.009|2-Sided|95.0|-1.87|-0.29|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696630|NCT01032135|3119208|Other||Odds Ratio (OR)|1.12||||0.79|2-Sided|95.0|0.48|2.6|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696631|NCT01032135|3119208|Other||Odds Ratio (OR)|0.54||||0.16|2-Sided|95.0|0.23|1.27|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696632|NCT01032135|3119208|Other||Odds Ratio (OR)|0.4||||0.0007|2-Sided|95.0|0.23|0.68|||Chi-squared|||The statistical analyses used data from all follow up assessments.|
1696633|NCT01032135|3119213|Other|||||||0.005|||||||Chi-squared||||
1696634|NCT01032135|3119214|Other|||||||0.02|||||||Chi-squared||||
1696635|NCT01032135|3119215|Other|||||||0.11|||||||Chi-squared||||
1696636|NCT01032070|3119229|Superiority or Other|||||||0.22||||||P-value is not adjusted for multiple comparisons.|Fisher Exact|||The study was not powered for this comparison due to small sample size.|
1696637|NCT01032018|3119232|Superiority or Other||Difference of back-transformed means.|-3.5||||0.01||95.0|-6.1|-0.7|||Mixed Models Analysis|||The trial was powered to detect a between-group difference in the 6-month change in depression symptoms. Assuming 5% attrition rate, we estimated that a sample of 150 patients would be needed to have 80% power to detect a clinically meaningful differential change in depression scores between groups of 0.46 SD.|
1696638|NCT01031979|3119233|Superiority or Other||Beta|-1.6||||0.03|2-Sided|95.0|-2.71|-0.49|||Hierarchical Linear Modeling||||
1696639|NCT01031979|3119234|Superiority or Other||Slope|-0.55||||0.58|2-Sided||||||Hierarchical Linear Modeling||||
1696640|NCT01031979|3119235|Superiority or Other||Slope|-0.87||||0.39|2-Sided||||||Hierarchical Linear Modeling||||
1696641|NCT01031979|3119236|Superiority or Other||Beta|-1.44|||<|0.001|2-Sided|95.0|-2.29|-0.59|||mixed effects/hierarchical linear model||||
1696642|NCT01031810|3119258|Superiority or Other||Mean Difference (Final Values)|11.56|Standard Deviation|10.81||0.012|2-Sided|95.0|3.25|19.86|||paired t-test 2 sided|||Compare the mean differences between baseline (week00) and week12 hamd17 summary scores|
1696643|NCT01031680|3119261|Superiority or Other||Risk Difference (RD)|12.5|Standard Error of the Mean|2.126|<|0.0001|2-Sided|95.0|8.3|16.6||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline value and stratum (gender)||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0|
1696644|NCT01031680|3119262|Superiority or Other||Mean Difference (Final Values)|-1.95|Standard Error of the Mean|0.8203||0.0174|2-Sided|95.0|-3.56|-0.34||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1696645|NCT01031680|3119263|Superiority or Other||Mean Difference (Final Values)|-2.27|Standard Error of the Mean|0.191|<|0.0001||95.0|-2.64|-1.89||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1696660|NCT01031004|3119329|Superiority or Other|||||||0.0466|||||||Fisher Exact|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.|
1696646|NCT01031680|3119264|Superiority or Other||Mean Difference (Final Values)|-1.97|Standard Error of the Mean|0.7898||0.0126|2-Sided|95.0|-3.52|-0.42||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1696647|NCT01031680|3119265|Superiority or Other||Risk Difference (RD)|9.9|||<|0.0001|2-Sided|95.0|7.0|12.9||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives|Cochran-Mantel-Haenszel|with age-by-insulin use-by-time from most recent qualifying CV event as stratum||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0|
1696648|NCT01031680|3119266|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.0473|<|0.0001|2-Sided|95.0|-0.56|-0.37||Significant at alpha=0.025 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives|ANCOVA|with treatment group and stratum as effects and baseline value as covariate for each endpoint|with stratum = age-by-insulin use-by-time from most recent qualifying CV event|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1696649|NCT01031069|3119293|Superiority|Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-16 type being above 1, with a statistically significant p-value.|Adjusted GMT ratio|3.05|||<|0.0001|2-Sided|97.5|1.84|5.06|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.||Adjusted GMT ratio for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.|
1696650|NCT01031069|3119293|Superiority|Superiority was defined as the lower limit of the 97.5% CI for the ratio of GMTs (Cervarix over Gardasil) for HPV-18 type being above 1, with a statistically significant p-value.|Adjusted GMT ratio|5.38|||<|0.0001|2-Sided|97.5|3.2|9.06|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV- subjects and including the vaccine group as fixed effect.||Adjusted GMT ratio for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV-/Cervarix Group) was superior to that of Gardasil vaccine (HIV-/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV- subjects.|
1696651|NCT01031069|3119310|Superiority|Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-16 type, with a statistically significant p-value.|Adjusted GMT ratio|2.74|||<|0.0001|2-Sided|95.0|1.83|4.11|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.||Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, following a sequential approach.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.
1696652|NCT01031069|3119310|Superiority|Superiority was defined as the lower limit of the 95% CI for the ratio of GMTs (Cervarix over Gardasil) being above 1 for HPV-18 type, with a statistically significant p-value.|Adjusted GMT ratio|7.44|||<|0.0001|2-Sided|95.0|4.79|11.54|||ANOVA|ANOVA model on the log10 transformation of the titers for HIV+ subjects and including the vaccine group as fixed effect.||Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was superior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) in HIV+ subjects, assessed following a sequential approach.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.
1696653|NCT01031069|3119311|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (>) 0.5 for HPV-18 type.|Adjusted GMT ratio|7.83|||||2-Sided|95.0|4.84|12.66||||||Adjusted GMT ratios for anti-HPV-18 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-18, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.
1696654|NCT01031069|3119311|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the ratio of GMTs (Cervarix over Gardasil) being above (>) 0.5 for HPV-16 type.|Adjusted GMT ratio|2.95|||||2-Sided|95.0|1.92|4.52||||||Adjusted GMT ratios for anti-HPV-16 neutra antibody (ED50): To demonstrate that the immunogenicity of Cervarix vaccine (HIV+/Cervarix Group) was non-inferior to that of Gardasil vaccine (HIV+/Gardasil Group), in terms of geometric mean titers (GMTs) against HPV-16, measured by Pseudovirion-based neutralization assay (PBNA) one month after the administration of the third dose of vaccine in HIV+ subjects.|Primary objectives were to be assessed sequentially: firstly, non-inferiority for both HPV-16 and HPV-18, and then, superiority for HPV-18 followed by superiority for HPV-16.
1696655|NCT01031004|3119324|Superiority or Other|||||||0.7217|||||||t-test, 2 sided|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.|
1696656|NCT01031004|3119325|Superiority or Other|||||||0.6403|||||||t-test, 2 sided|||The hypothesis is that narafilcon B will not be statistically different from etafilcon A.|
1696657|NCT01031004|3119326|Superiority or Other|||||||0.5774|||||||Chi-squared|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.|
1696658|NCT01031004|3119327|Superiority or Other|||||||0.4605|||||||Chi-squared|||The hypothesis is that narafilcon B is not statistically different from etafilcon A.|
1697890|NCT01020435|3120647|Other||Mean Difference (Final Values)|1.5|||||2-Sided|95.0|-2.1|5.0||||||Wk 6 - DBP (Unadjusted)|
1696661|NCT01030965|3119344|Superiority or Other||Mean Difference (Final Values)|0.15|||<|0.001|2-Sided|95.0|0.08|0.22|||Repeated Measures Analysis of Covariance||||
1696662|NCT01030965|3119344|Superiority or Other||Median Difference (Final Values)|0.168|||<|0.001|2-Sided|95.0|0.099|0.238|||Repeated Measures Analysis of Covariance||||
1696663|NCT01030965|3119344|Superiority or Other||Mean Difference (Final Values)|0.159|||<|0.001|2-Sided|95.0|0.088|0.229|||Repeated Measures Analysis of Covariance||||
1696664|NCT01030341|3119443|Non-Inferiority or Equivalence (legacy)|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in PAGI-QOL score from screening to 24 weeks of treatment.|
1696665|NCT01030341|3119443|Non-Inferiority or Equivalence (legacy)|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in PAGI-QOL score from screening to 12 weeks of treatment.|
1696666|NCT01030341|3119443|Non-Inferiority or Equivalence (legacy)|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in GCSI composite score from screening to 24 weeks of treatment.|
1696667|NCT01030341|3119443|Non-Inferiority or Equivalence (legacy)|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in GCSI composite score from screening to 12 weeks of treatment.|
1696668|NCT01030341|3119443|Non-Inferiority or Equivalence (legacy)|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in total GCSI score from screening to 24 weeks of treatment.|
1696669|NCT01030341|3119443|Non-Inferiority or Equivalence (legacy)|Mean change = 0|||||<|0.0001|||||||paired t-test|||Null hypothesis: No difference in total GCSI score from screening to 12 weeks of treatment.|
1696670|NCT01030341|3119444|Non-Inferiority or Equivalence (legacy)|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p < 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (>300 mg/dL) during the screening phase and treatment phase respectively.|
1696671|NCT01030341|3119444|Non-Inferiority or Equivalence (legacy)|Type I error: 0.05; power: 0.9|||||<|0.04||||||Threshold for statistical significance: p < 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hyperglycemic excursions (>180 mg/dL) during the screening phase and treatment phase respectively.|
1696672|NCT01030341|3119444|Non-Inferiority or Equivalence (legacy)|Type I error: 0.05; power: 0.9|||||<|0.005||||||Threshold for statistical significance: p < 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of euglycemic excursions (70-180 mg/dL) during the screening phase and treatment phase respectively.|
1696673|NCT01030341|3119444|Non-Inferiority or Equivalence (legacy)|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p < 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (<70 mg/dL) during the screening phase and treatment phase respectively.|
1696674|NCT01030341|3119444|Non-Inferiority or Equivalence (legacy)|Type I error: 0.05; power: 0.9|||||<|0.0001||||||Threshold for statistical significance: p < 0.05|Regression, Logistic|Generalized estimating equations (GEE) with independent working correlation to account for correlated data comparing screening and treatment phases||Null hypothesis: Difference of 0% in the frequencies of hypoglycemic excursions (<50 mg/dL) during the screening phase and treatment phase respectively.|
1696675|NCT01030133|3119452|Superiority or Other|||||||0.05|||||||Chi-squared|0.75|||
1696676|NCT01029886|3119460|Superiority or Other||Least Squares Mean Difference|0.01|Standard Error of the Mean|0.5||0.981|2-Sided|95.0|-0.96|0.98|||Mixed Models Analysis|||MMRM model includes treatment, baseline DBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.|
1696677|NCT01029886|3119461|Superiority or Other||Least Squares Mean Difference|0.97|Standard Error of the Mean|0.76||0.205|2-Sided|95.0|-0.53|2.47|||Mixed Models Analysis|||MMRM model includes treatment, baseline SBP, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.|
1696678|NCT01029886|3119462|Superiority or Other||Least Squares Mean Difference|1.09|Standard Error of the Mean|0.03|<|0.001|2-Sided|95.0|1.04|1.15|||Mixed Models Analysis|||Fasting triglycerides were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM model with treatment, baseline fasting triglycerides, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.|
1696679|NCT01029886|3119463|Superiority or Other||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.01||0.832|2-Sided|95.0|-0.02|0.02|||Mixed Models Analysis|||MMRM model includes treatment, baseline HDL-C, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.|
1696680|NCT01029886|3119464|Superiority or Other||Least Squares Mean Difference|0.09|Standard Error of the Mean|0.05||0.079|2-Sided|95.0|-0.01|0.19|||Mixed Models Analysis|||MMRM model includes treatment, baseline total cholesterol, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.|
1696681|NCT01029886|3119465|Superiority or Other||Least Squares Mean Difference|0.9|Standard Error of the Mean|0.26|<|0.001|2-Sided|95.0|0.39|1.4|||Mixed Models Analysis|||MMRM model includes treatment, baseline body weight, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.|
1696682|NCT01029886|3119466|Superiority or Other||Least Squares Mean Difference|0.36|Standard Error of the Mean|0.15||0.021|2-Sided|95.0|0.05|0.66|||Mixed Models Analysis|||MMRM model includes treatment, baseline fasting serum glucose, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.|
1696683|NCT01029886|3119467|Superiority or Other|||||||0.011|||||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c <7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel test, in which HbA1c stratum, country, and background OAD served as stratification factors.|
1696684|NCT01029886|3119468|Non-Inferiority or Equivalence|Superiority of exenatide once weekly with respect to change in HbA1c was concluded if the upper limit of the 2-sided 95% confidence interval (CI) for the treatment difference (exenatide once weekly minus liraglutide) was less than zero. Non-inferiority was concluded if the upper limit of the CI was <0.25%.|Least Squares Mean Difference|0.21|Standard Error of the Mean|0.07||0.002|2-Sided|95.0|0.08|0.33|||Mixed Models Analysis|||A sample of 408 subjects in each treatment arm would provide approximately 90% power to detect a true difference between treatments of 0.25% in change in HbA1c from baseline with a 2 sided t-test at a significance level of 0.05, assuming a common standard deviation of 1.1%. MMRM model includes treatment, baseline HbA1c, HbA1c stratum, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects and subject and error as random effects.|
1696685|NCT01029691|3119502|Superiority|||||||0.4|||||||Fisher Exact||||
1696686|NCT01029691|3119506|Superiority|||||||0.012||||||Unadjusted|t-test, 2 sided||||
1696687|NCT01029691|3119507|Superiority|||||||0.085|||||||Chi-squared||||
1696688|NCT01029691|3119508|Superiority|||||||0.75|||||||t-test, 2 sided|||Unadjusted diastolic blood pressure at week 1|
1696689|NCT01029691|3119508|Superiority|||||||0.61|||||||t-test, 2 sided|||Unadjusted systolic blood pressure at week 1|
1696690|NCT01029691|3119508|Superiority|||||||0.66|||||||t-test, 2 sided|||Unadjusted diastolic blood pressure at baseline between groups|
1696691|NCT01029691|3119508|Superiority|||||||0.45|||||||t-test, 2 sided|||unadjusted systolic blood pressure at baseline between groups|
1696692|NCT01029405|3119564|Superiority or Other||||||<|0.001|||||||2-sided sign test||||
1696693|NCT01029262|3119591|Superiority||Risk Ratio (RR)|1.759||||0.017|2-Sided|95.0|1.083|2.856||p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.|Fisher Exact||||
1696694|NCT01029262|3119592|Superiority|||||||0.052||||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24|
1696695|NCT01029262|3119592|Superiority|||||||0.476||||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12|
1696696|NCT01029262|3119593|Superiority|||||||0.279||||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24|
1696697|NCT01029262|3119593|Superiority|||||||0.792||||||The P-values were calculated based on Fisher exact test.|Fisher Exact|||Week 12|
1696698|NCT01029262|3119594|Superiority|||||||0.172||||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24|
1696699|NCT01029262|3119594|Superiority|||||||0.119||||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12|
1696700|NCT01029262|3119595|Superiority|||||||0.568||||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24|
1696701|NCT01029262|3119595|Superiority|||||||0.825||||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12|
1696702|NCT01029262|3119596|Superiority|||||||0.448||||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 24|
1696703|NCT01029262|3119596|Superiority|||||||0.042||||||The P-values are calculated based on Fisher exact test.|Fisher Exact|||Week 12|
1696704|NCT01029262|3119597|Superiority|||||||0.1053||||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 1 sided|||Week 24|
1696705|NCT01029262|3119597|Superiority|||||||0.2848|||||||t-test, 2 sided|P-value is based on a two-sample t-test comparing the difference between treatments||Week 12|
1696706|NCT01029262|3119598|Superiority|||||||0.575||||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24|
1696707|NCT01029262|3119598|Superiority|||||||0.6408||||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 12|
1696708|NCT01029262|3119599|Superiority|||||||0.1714||||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24|
1696709|NCT01029262|3119599|Superiority|||||||0.3975|||||||t-test, 2 sided|P-value is based on a two-sample t-test comparing the difference between treatments.||Week 12|
1696710|NCT01029262|3119600|Superiority|||||||0.1729||||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 2 sided|||Week 24|
1696711|NCT01029262|3119600|Superiority|||||||0.6957||||||P-value is based on a two-sample t-test comparing the difference between treatments|t-test, 2 sided|||Week 12|
1696712|NCT01029262|3119601|Superiority|||||||0.0759||||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 24|
1696713|NCT01029262|3119601|Superiority|||||||0.2909||||||P-value is based on a two-sample t-test comparing the difference between treatments.|t-test, 2 sided|||Week 12|
1696714|NCT01029262|3119602|Superiority|||||||0.047||||||3]: P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24|
1696715|NCT01029262|3119602|Superiority|||||||0.265||||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12|
1696716|NCT01029262|3119603|Superiority|||||||0.46||||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA||||
1696717|NCT01029262|3119603|Superiority|||||||0.746||||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12|
1696718|NCT01029262|3119604|Superiority|||||||0.116||||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24|
1696719|NCT01029262|3119604|Superiority|||||||0.424||||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 12|
1696720|NCT01029262|3119605|Superiority|||||||0.251||||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24|
1696721|NCT01029262|3119605|Superiority|||||||0.76||||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score|ANOVA|||Week 12|
1696814|NCT01027871|3119746|Superiority or Other|||||||0.609||||||"The statistical significance level is 0.10.~P-value is for HbA1c <7.0%"|Fisher Exact||||
1696722|NCT01029262|3119606|Superiority|||||||0.071||||||P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.|ANOVA|||Week 24|
1696723|NCT01029262|3119606|Superiority|||||||0.323|||||||ANOVA|P-value from ANOVA comparison for change from baseline between lenalidomide and placebo adjusted with baseline score.||Week 12|
1696724|NCT01029262|3119607|Superiority|||||||0.508|||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 48 (±3 days)|
1696725|NCT01029262|3119607|Superiority|||||||1|||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 36 (±3 days)|
1696726|NCT01029262|3119607|Superiority|||||||0.391|||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 24 (±3 days)|
1696727|NCT01029262|3119607|Superiority|||||||0.371|||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Week 12 (±3 days)|
1696728|NCT01029262|3119607|Superiority|||||||0.823|||||||Fisher Exact|The p-values are calculated based on the Fisher exact test||Baseline|
1696729|NCT01029262|3119609|Superiority|||||||0.98||||||p-value from log-rank test to compare lenalidomide and placebo.|Log Rank||||
1696730|NCT01029262|3119610|Superiority|||||||0.864||||||p-value from log-rank test to compare lenalidomide and placebo.|Log Rank||||
1696731|NCT01029262|3119612|Superiority||Risk Ratio (RR)|1.276||||0.252|2-Sided|95.0|0.867|1.877||p-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.|Fisher Exact||||
1696732|NCT01029262|3119613|Superiority|||||||0.639|||||||Log Rank|p-value from log-rank test to compare lenalidomide and placebo.|||
1696733|NCT01029262|3119614|Superiority or Other||Risk Ratio (RR)|0.0|||<|0.001|2-Sided|95.0|0.0||NA for risk ratio is due to 0 responder in placebo group.|P-value is from Fisher's exact test to compare the lenalidomide arm to the placebo arm.|Fisher Exact||||
1696734|NCT01029262|3119615|Superiority|||||||1|||||||Fisher Exact|p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group.|||
1696735|NCT01029262|3119616|Superiority||Risk Ratio (RR)|10.616|||<|0.001|2-Sided|95.0|2.639|42.702|||Fisher Exact|p-value is from Fisher's exact test to compare lenalidomide treatment group to placebo group|||
1696736|NCT01028911|3119623|Superiority or Other||Adjusted Geometric Means Ratio|119.82|||||2-Sided|90.0|75.9|189.16||||||Day 30: Natural log transformed AUCtau of donepezil was analyzed using a mixed effect model with sequence, day and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Values were back-transformed from the log scale.|
1696737|NCT01028911|3119624|Superiority or Other||Adjusted Geometric Means Ratio|128.4|||||2-Sided|90.0|75.9|217.21||||||Day 30: Natural log transformed AUCtau of donepezil was analyzed using a mixed effect model with sequence, day and treatment as fixed effects and participant within sequence as a random effect.The adjusted mean differences and 90% confidence intervals for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% confidence intervals for the ratios. Values were back-transformed from the log scale.|
1696738|NCT01028677|3119656|Superiority or Other|||||||1|||||||t-test, 2 sided|||Distress analysis|
1696739|NCT01028677|3119656|Superiority or Other|||||||0.681|||||||t-test, 2 sided|||Fantasy Analysis|
1696740|NCT01028677|3119656|Superiority or Other|||||||0.135|||||||t-test, 2 sided|||Emotional empathy analysis|
1696741|NCT01028677|3119656|Superiority or Other|||||||0.03|||||||t-test, 2 sided|||Perspective-Taking|
1696742|NCT01028677|3119656|Superiority or Other|||||||1|||||||t-test, 2 sided|||Distress analysis|
1696743|NCT01028677|3119656|Superiority or Other|||||||0.784||||||Not adjusted for multiple comparisons|t-test, 2 sided|||IRI-total|
1696744|NCT01028677|3119658|Superiority or Other|||||||0.03||||||Not adjusted for multiple comparisons|t-test, 2 sided||||
1696745|NCT01028677|3119660|Superiority|||||||0.025|||||||t-test, 2 sided|||General Symptoms|
1696746|NCT01028677|3119660|Superiority|||||||0.08|||||||t-test, 2 sided|||Negative Symptoms|
1696747|NCT01028677|3119660|Superiority|||||||0.05|||||||t-test, 2 sided|||Positive Symptoms|
1696748|NCT01028677|3119660|Superiority|||||||0.04|||||||t-test, 2 sided|||General Symptoms|
1696749|NCT01028677|3119660|Superiority|||||||0.002|||||||t-test, 2 sided|||Negative Symptoms|
1696750|NCT01028677|3119660|Superiority|||||||0.008|||||||t-test, 2 sided|||Positive Symptoms|
1696751|NCT01028677|3119661|Superiority or Other|||||||0.61||||||Not adjusted for multiple comparisons|t-test, 1 sided|||Analysis of fear emotion|
1696752|NCT01028560|3119675|Superiority||Rate ratio|1.27||||0.289|2-Sided|95.0|0.82|1.96||Poisson regression model for treatment arm adjusting for gender, race and history of hospitalization was used to analyze the corticosteroid burst and the time period contributed by each child in years were fitted as offset.|Poisson regression|Poisson regression model with robust variance with contributed person years used as offset was modeled.||Null hypothesis = Incidence rate of CSB in each group are same. Poisson regression adjusting for gender, race and history of hospitalization was used to analyze the corticosteroid burst.|
1696753|NCT01028560|3119676|Superiority||Slope|0.56||||0.546|2-Sided|95.0|-2.18|3.29||Test of parallelism (group x time) hypothesis P-value.|covariance pattern (rep. measure) model|Within group difference p-values ( baseline vs 3-years) in control and intervention arm were 0.56 and 0.20 respectively.|The estimated slope reported is for year 3 from the covariance pattern model with autoregressive covariance structure.|Covariance Pattern Model with autoregressive covariance structure with REML (Restricted Estimation of Maximum Likelihood) with time and role as categorical variable was modeled.|
1696754|NCT01028560|3119677|Superiority|||||||0.677||||||Chi-square test (proportion of new sensitizations versus unchanged or lost sensitizations in each group, intention-to treat analysis).|Chi-squared||||
1696768|NCT01027871|3119730|Superiority or Other|||||||0.518||||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Negative Binomial Model||||
1696769|NCT01027871|3119730|Superiority or Other|||||||0.561||||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Negative Binomial Model||||
1697891|NCT01020435|3120647|Other||Mean Difference (Final Values)|3.5|||||2-Sided|95.0|-1.9|8.9||||||Wk 6 - SBP (Unadjusted)|
1696755|NCT01028560|3119678|Other||Mean Difference (Final Values)|-1.85|Standard Error of the Mean|7.39||0.8|2-Sided|95.0|-19.54|15.84||Post estimation means were tested between the intervention arms after LME model at year 3 and the p- values were adjusted using Bonferroni correction.|contrast testing post mixed model||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.|
1696756|NCT01028560|3119678|Other||Mean Difference (Final Values)|-1.72|Standard Error of the Mean|5.89||0.77|2-Sided|95.0|-15.83|12.38||Post estimation means were tested between the intervention arms after LME model at year 2 and the p- value was unadjusted p value|contrast testing post mixed model]||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.|
1696757|NCT01028560|3119678|Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|4.97||0.978|2-Sided|95.0|-11.76|12.03||Post estimation means were tested between the intervention arms after LME model at year 1 and the p- values were adjusted using Bonferroni correction.|contrast testing post mixed model||The difference is IT-Control group and the confidence interval is Bonferroni CI|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection between immunotherapy and control groups were smoothed over two month period with a median score values.|
1696758|NCT01028560|3119678|Other||Slope|0.55|Standard Error of the Mean|0.22||0.013|2-Sided|95.0|0.11|0.99|||Mixed Models Analysis|The above (quadratic) slope is for control group|The above is the (quadratic) slope is for control group and is for 1 month increase in time.|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection were smoothed over two month period with median score values.|
1696759|NCT01028560|3119678|Other||Slope|0.19|Standard Error of the Mean|0.22||0.38|2-Sided|95.0|-0.24|0.63|||Mixed Models Analysis||The above is the slope for immunotherapy group . The (quadratic) slope is for 1 month increase in time.|Linear mixed effects model (LME) with random coefficients model was fitted with Restricted Maximum Likelihood estimation. The functional form of the model was quadratic and the model adjusted for gender, race, ethnicity and number of asthma hospitalizations since birth. Unequal data collection were smoothed over two month period with a median score values.|
1696760|NCT01028391|3119679|Superiority or Other||Mean Difference (Net)|-8.5|Standard Error of the Mean|4.0||||95.0|-16.3|-0.7|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0 of the 24-week base study) FPG.||
1696761|NCT01028391|3119680|Superiority or Other||Mean Difference (Net)|-0.51|Standard Error of the Mean|4.0||||95.0|-0.76|-0.26|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0 of the 24-week base study) HbA1c.||
1696762|NCT01028014|3119715|Superiority or Other||||||>|0.05||||||P values comparing differences across groups, as well as within group changes, were all >0.05.P-values were not adjusted for multiple testing; p<0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.|
1696763|NCT01028014|3119716|Superiority or Other||||||>|0.05||||||P values comparing differences across groups, as well as within group changes, were all >0.05.P-values were not adjusted for multiple testing; p<0.05 was considered statistically significant.|Wilcoxon (Mann-Whitney)|||Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.|
1696764|NCT01027871|3119729|Superiority or Other||Least Squares Mean Difference (Final)|-0.1||||0.293|2-Sided|90.0|-0.25|0.05||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696765|NCT01027871|3119729|Superiority or Other||Least Squares Mean Difference (Final)|-0.01||||0.927|2-Sided|90.0|-0.16|0.15||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696766|NCT01027871|3119729|Superiority or Other||Least Squares Mean Difference (Final)|0.0||||0.972|2-Sided|90.0|-0.18|0.19||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY2605541 Algorithm 2 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696767|NCT01027871|3119729|Superiority or Other||Least Squares Mean Difference (Final)|-0.01||||0.938|2-Sided|90.0|-0.2|0.18||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY2605541 Algorithm 1 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696813|NCT01027871|3119746|Superiority or Other|||||||0.314||||||"The statistical significance level is 0.10.~P-value is for HbA1c ≤6.5%"|Fisher Exact||||
1696770|NCT01027871|3119731|Superiority or Other|||||||0.224||||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Fisher Exact||||
1696771|NCT01027871|3119731|Superiority or Other|||||||0.046||||||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Fisher Exact||||
1696772|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.29||||0.314|2-Sided|90.0|-0.75|0.18||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696773|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|0.24||||0.403|2-Sided|90.0|-0.23|0.72||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696774|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.7||||0.043|2-Sided|90.0|-1.28|-0.13||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696775|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.28||||0.438|2-Sided|90.0|-0.86|0.31||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696776|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.42||||0.21|2-Sided|90.0|-0.98|0.13||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696777|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.5||||0.147|2-Sided|90.0|-1.07|0.07||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696778|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.16||||0.614|2-Sided|90.0|-0.67|0.36||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696779|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.15||||0.642|2-Sided|90.0|-0.68|0.38||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for evening pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696780|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.27||||0.412|2-Sided|90.0|-0.8|0.27||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696781|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.4||||0.229|2-Sided|90.0|-0.95|0.15||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696782|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.69||||0.033|2-Sided|90.0|-1.22|-0.16||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696783|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.07||||0.838||90.0|-0.61|0.48||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696784|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.83||||0.016|2-Sided|90.0|-1.4|-0.26||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696785|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.26||||0.454||90.0|-0.85|0.32||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696786|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|-0.14||||0.571|2-Sided|90.0|-0.54|0.26||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696787|NCT01027871|3119733|Superiority or Other||Least Squares Mean Difference (Final)|0.26||||0.305|2-Sided|90.0|-0.16|0.67||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for morning pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696788|NCT01027871|3119734|Superiority or Other|||||||1||||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact||||
1696789|NCT01027871|3119734|Superiority or Other|||||||0.515||||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c <7.0%."|Fisher Exact||||
1696790|NCT01027871|3119734|Superiority or Other|||||||0.569||||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact||||
1696791|NCT01027871|3119734|Superiority or Other|||||||0.139||||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c <7.0%."|Fisher Exact||||
1696792|NCT01027871|3119735|Superiority or Other|||||||0.722||||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact||||
1696793|NCT01027871|3119735|Superiority or Other|||||||0.879||||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c <7.0%."|Fisher Exact||||
1696794|NCT01027871|3119735|Superiority or Other|||||||0.287||||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c ≤6.5%."|Fisher Exact||||
1696795|NCT01027871|3119735|Superiority or Other|||||||0.273||||||"The statistical significance level is 0.10 with no adjustments for multiple comparisons.~P-value is for HbA1c <7.0%."|Fisher Exact||||
1696796|NCT01027871|3119736|Superiority or Other||Least Squares Mean Difference (Final)|-0.17||||0.045|2-Sided|90.0|-0.32|-0.03||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696797|NCT01027871|3119736|Superiority or Other||Least Squares Mean Difference (Final)|-0.01||||0.88|2-Sided|90.0|-0.16|0.13||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696798|NCT01027871|3119737|Superiority or Other||Least Squares Mean Difference (Final)|-0.17||||0.542|2-Sided|90.0|-0.62|0.29||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 2 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696799|NCT01027871|3119737|Superiority or Other||Least Squares Mean Difference (Final)|-0.4||||0.159|2-Sided|90.0|-0.87|0.07||The statistical significance level is 0.10 with no adjustments for multiple comparisons.|Mixed Models Analysis||The Least Squares Mean Difference = LY2605541 Algorithm 1 – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696800|NCT01027871|3119739|Superiority or Other||Least Squares Mean Difference (Final)|-0.03||||0.687|2-Sided|90.0|-0.16|0.1||"The statistical significance level is 0.10.~P-value is for Week 12."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696801|NCT01027871|3119739|Superiority or Other||Least Squares Mean Difference (Final)|-0.01||||0.937||90.0|-0.16|0.14||"The statistical significance level is 0.10.~P-value is for baseline."|ANOVA||The Least Squares Mean Difference = LY Combined – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696802|NCT01027871|3119741|Superiority or Other|||||||0.804||||||The statistical significance level is 0.10.|Negative Binomial Model||||
1696803|NCT01027871|3119742|Superiority or Other|||||||0.162||||||The statistical significance level is 0.10.|Fisher Exact||||
1696804|NCT01027871|3119744|Superiority or Other||Least Squares Mean Difference (Final)|0.1||||0.676|2-Sided|90.0|-0.3|0.5||"The statistical significance level is 0.10.~P-value is for 0300 hours BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696805|NCT01027871|3119744|Superiority or Other||Least Squares Mean Difference (Final)|-0.29||||0.339|2-Sided|90.0|-0.79|0.21||"The statistical significance level is 0.10.~P-value is for bed time BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696806|NCT01027871|3119744|Superiority or Other||Least Squares Mean Difference (Final)|-0.25||||0.387|2-Sided|90.0|-0.73|0.23||"The statistical significance level is 0.10.~P-value is for evening 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696807|NCT01027871|3119744|Superiority or Other||Least Squares Mean Difference (Final)|-0.12||||0.654|2-Sided|90.0|-0.56|0.32||"The statistical significance level is 0.10.~P-value is for evening pre-meal BG"|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696808|NCT01027871|3119744|Superiority or Other||Least Squares Mean Difference (Final)|-0.26||||0.342|2-Sided|90.0|-0.72|0.19||"The statistical significance level is 0.10.~P-value is for midday 2-hr postprandial BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696809|NCT01027871|3119744|Superiority or Other||Least Squares Mean Difference (Final)|-0.25||||0.36|2-Sided|90.0|-0.7|0.2||"The statistical significance level is 0.10.~P-value is for midday pre-meal BG."|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696810|NCT01027871|3119744|Superiority or Other||Least Squares Mean Difference (Final)|-0.43||||0.144|2-Sided|90.0|-0.92|0.05||"The statistical significance level is 0.10.~P- value is for morning 2-hr postprandial BG"|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696811|NCT01027871|3119745|Superiority or Other|||||||0.811||||||"The statistical significance level is 0.10.~P- value is for HbA1c ≤6.5%"|Fisher Exact||||
1696812|NCT01027871|3119745|Superiority or Other|||||||0.375||||||"The statistical significance level is 0.10.~P-value is for HbA1c <7.0%."|Fisher Exact||||
1696815|NCT01027871|3119747|Superiority or Other||Least Squares Mean Difference (Final)|-0.09||||0.197|2-Sided|90.0|-0.21|0.03||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696816|NCT01027871|3119748|Superiority or Other||Least Squares Mean Difference (Final)|-0.2||||0.388|2-Sided|90.0|-0.59|0.19||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696817|NCT01027871|3119749|Superiority or Other||Least Squares Mean Difference (Final)|0.17||||0.433|2-Sided|90.0|-0.18|0.52||The statistical significance level is 0.10.|Mixed Models Analysis||The Least Squares Mean Difference = LY Combined – Insulin Glargine; and 90% confidence interval (CI) = 90% CI of the least squares mean difference.||
1696818|NCT01027845|3119770|Non-Inferiority|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1102 in the 105553 10Pn Group; GMC= 0.53 µg/mL with 95% CI = (0.50 to 0.57).|GMC ratio|0.25|||||2-Sided|95.0|0.21|0.29||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 23F."|
1696819|NCT01027845|3119770|Non-Inferiority|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1104 in the 105553 10Pn Group; GMC= 1.84 µg/mL with 95% CI = (1.71 to 1.98).|GMC ratio|0.11|||||2-Sided|95.0|0.09|0.12||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 19F."|
1696820|NCT01027845|3119770|Non-Inferiority|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1102 in the 105553 10Pn Group; GMC= 1.66 µg/mL with 95% CI = (1.56 to 1.77).|GMC ratio|0.1|||||2-Sided|95.0|0.09|0.12||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 18C."|
1696821|NCT01027845|3119770|Non-Inferiority|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 2.90 µg/mL with 95% CI = (2.75 to 3.05).|GMC ratio|0.29|||||2-Sided|95.0|0.25|0.33||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 14."|
1696822|NCT01027845|3119770|Non-Inferiority|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1103 in the 105553 10Pn Group; GMC= 1.32 µg/mL with 95% CI = (1.25 to 1.38).|GMC ratio|0.24|||||2-Sided|95.0|0.22|0.27||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 9V."|
1696823|NCT01027845|3119770|Non-Inferiority|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1107 in the 105553 10Pn Group; GMC= 1.72 µg/mL with 95% CI = (1.64 to 1.80).|GMC ratio|0.28|||||2-Sided|95.0|0.25|0.31||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 7F."|
1696837|NCT01027364|3119813|Superiority or Other||Bleeding Rate Ratio|0.13|||<|0.001|2-Sided|95.0|0.08|0.2||A hierarchical approach was applied to the comparison of the annualized bleeding rates between the prophylaxis arms and the episodic arm.|negative binomial model|||The null hypothesis for the primary endpoint is no difference between any prevention regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations.|
1697169|NCT01026038|3120036|Superiority or Other||||||>|0.215|||||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1696824|NCT01027845|3119770|Non-Inferiority|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 0.33 µg/mL with 95% CI = (0.30 to 0.36).|GMC ratio|0.19|||||2-Sided|95.0|0.16|0.23||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 6B."|
1696825|NCT01027845|3119770|Non-Inferiority|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1104 in the 105553 10Pn Group; GMC= 1.70 µg/mL with 95% CI = (1.62 to 1.78).|GMC ratio|0.26|||||2-Sided|95.0|0.23|0.29||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 5."|
1696826|NCT01027845|3119770|Non-Inferiority|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1106 in the 105553 10Pn Group; GMC= 1.45 µg/mL with 95% CI = (1.38 to 1.53).|GMC ratio|0.22|||||2-Sided|95.0|0.2|0.25||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 4."|
1696827|NCT01027845|3119770|Non-Inferiority|Comparability to the 105553 study in terms of non-inferiority was demonstrated if the upper limit (UL) of the two-sided 95% confidence interval(CI) on the GMC ratios (GMCs from 105553 10Pn Group over GMCs from 10Pn Group) were below a limit of 2-fold for all 10 vaccine pneumococcal serotypes. Number of participants analysed =1100 in the 105553 10Pn Group; GMC= 1.05 µg/mL with 95% CI = (1.00 to 1.10).|GMC ratio|0.16|||||2-Sided|95.0|0.14|0.18||||||"Immune response of Synflorix vaccine tested between subjects of the 10Pn Group of the study and healthy European subjects from the 10PN-PD-DIT-001 (105553) study (with following indication: 3-dose primary vaccination of infants between 6 to 12 weeks of age at the time of the first vaccination with Synflorix), that formed the 105553 10Pn Group.~At 1 month after primary immunization (post-dose 3), ELISA GMC ratio (105553 10Pn Group over 10Pn Group) was calculated for pneumococcal serotype 1."|
1696828|NCT01027806|3119773|Superiority||||||<|0.001|||||||Fisher Exact||||
1696829|NCT01027780|3119774|Superiority or Other|||||||0.03||||||Difference between groups following intervention|ANOVA||||
1696830|NCT01027780|3119775|Superiority or Other|||||||0.04||||||Note that this is the p value for differences between groups immediately following the intervention|GEE|Generalized estimating equations (GEE) approach was used to assess robustness of population parameters, such as treatment effects.|||
1696831|NCT01027780|3119776|Superiority or Other|||||||0.007||||||Please note that this analysis tested the differences between groups following the intervention.|GEE|Generalized estimating equations (GEE) approach was used to assess robustness of population parameters, such as treatment effects.|||
1696832|NCT01027754|3119781|Superiority or Other (legacy)|||||||0.15|||||||Wilcoxon (Mann-Whitney)||||
1696833|NCT01027754|3119790|Superiority or Other (legacy)|||||||0.24|||||||Fisher Exact||||
1696834|NCT01027754|3119791|Superiority or Other (legacy)|||||||0.03|||||||Fisher Exact||||
1696835|NCT01027702|3119793|Other|||||||||||||||||"This was a dose-escalation study to determine a target DLI dose at which the:~Probability of CD4+ cells > 100/µL by Day +120 is at least 66% and~Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3."|"The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:~If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.~If none of the initial three patients at a dose level experienced grade II/III GVHD and < 2/3 had a CD4+ count > 100 at Day +120, the next three patients were assigned to the next higher dose level.~If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or > 2/3 have a CD4+ count > 100 at Day +120, the dose was repeated for the next 3 patients.~The dose of 5 x 10^4 CD3+ cells/kg was determined to be the optimal dose."
1696836|NCT01027702|3119794|Other|||||||||||||||||"This was a dose-escalation study to determine a target DLI dose at which the:~Probability of CD4+ cells > 100/µL by Day +120 is at least 66% and~Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3."|"The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:~If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.~If none of the initial three patients at a dose level experienced grade II/III GVHD and < 2/3 had a CD4+ count > 100 at Day +120, the next three patients were assigned to the next higher dose level.~If 1 out of 3 patients had grade III GVHD or 1 – 2 out of 3 patients had grade II GVHD and/or > 2/3 have a CD4+ count > 100 at Day +120, the dose was repeated for the next 3 patients.~The dose of 5 x 10^4 CD3+ cells/kg was determined to be the optimal dose."
1697170|NCT01026038|3120036|Superiority or Other||||||>|0.333|||||||Fisher Exact|||Fever (>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1696838|NCT01027364|3119813|Superiority or Other||Bleeding Rate Ratio|0.17|||<|0.001|2-Sided|95.0|0.11|0.24||A hierarchical approach was applied to the comparison of the annualized bleeding rates between the prophylaxis arms and the episodic arm.|negative binomial model|||The null hypothesis for the primary endpoint is no difference between any prevention regimen and the on-demand regimen. The sample size of this study was mainly based on clinical rather than statistical considerations. However it was projected to have > 95% power at the 2-sided 0.05 level of significance, based upon this hypothesis test.|
1696839|NCT01026818|3119934|Superiority or Other||LS Mean Differences|3.16|Standard Error of the Mean|1.46||0.031|2-Sided|95.0|0.29|6.03||P-value is for girth.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.|||
1696840|NCT01026818|3119934|Superiority or Other||LS Mean Differences|2.37|Standard Error of the Mean|1.49||0.112|2-Sided|95.0|-0.55|5.3||P-value is for girth.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.|||
1696841|NCT01026818|3119934|Superiority or Other||LS Mean Differences|-1.53|Standard Error of the Mean|1.87||0.413|2-Sided|95.0|-5.2|2.14||P-value is for length.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.|||
1696842|NCT01026818|3119934|Superiority or Other||LS Mean Differences|4.2|Standard Error of the Mean|1.89||0.028|2-Sided|95.0|0.47|7.93||P-value is for length.|ANCOVA|ANCOVA model included terms for treatment, baseline, age group and country.|||
1696843|NCT01026818|3119935|Superiority or Other||LS Mean Differences|-0.09|Standard Error of the Mean|1.3||0.943|2-Sided|95.0|-2.65|2.46||P-value is for Hormonal - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696844|NCT01026818|3119935|Superiority or Other||LS Mean Differences|-0.53|Standard Error of the Mean|1.34||0.692|2-Sided|95.0|-3.16|2.1||P-value is for Hormonal - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696845|NCT01026818|3119935|Superiority or Other||LS Mean Differences|2.89|Standard Error of the Mean|1.44||0.045|2-Sided|95.0|0.06|5.72||P-value is for Hormonal - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696846|NCT01026818|3119935|Superiority or Other||LS Mean Differences|1.9|Standard Error of the Mean|1.47||0.197|2-Sided|95.0|-0.99|4.79||P-value is for Hormonal - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696847|NCT01026818|3119935|Superiority or Other||LS Mean Differences|-0.79|Standard Error of the Mean|3.72||0.832|2-Sided|95.0|-8.11|6.53||P-value is for Sexual - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696848|NCT01026818|3119935|Superiority or Other||LS Mean Differences|3.18|Standard Error of the Mean|3.82||0.406|2-Sided|95.0|-4.34|10.69||P-value is for Sexual - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696849|NCT01026818|3119935|Superiority or Other||LS Mean Differences|2.69|Standard Error of the Mean|3.21||0.403|2-Sided|95.0|-3.63|9.0||P-value is for Sexual - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696850|NCT01026818|3119935|Superiority or Other||LS Mean Differences|9.55|Standard Error of the Mean|3.28||0.004|2-Sided|95.0|3.1|15.99||P-value is for Sexual - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696851|NCT01026818|3119935|Superiority or Other||LS Mean Differences|-0.29|Standard Error of the Mean|1.22||0.813|2-Sided|95.0|-2.69|2.12||P-value is for Bowel - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696852|NCT01026818|3119935|Superiority or Other||LS Mean Differences|0.1|Standard Error of the Mean|1.25||0.938|2-Sided|95.0|-2.37|2.57||P-value is for Bowel - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696853|NCT01026818|3119935|Superiority or Other||LS Mean Differences|-0.21|Standard Error of the Mean|1.24||0.868|2-Sided|95.0|-2.64|2.23||P-value is for Bowel - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696854|NCT01026818|3119935|Superiority or Other||LS Mean Differences|-0.54|Standard Error of the Mean|1.27||0.671|2-Sided|95.0|-3.03|1.95||P-value is for Bowel - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696855|NCT01026818|3119935|Superiority or Other||LS Mean Differences|1.52|Standard Error of the Mean|1.32||0.251|2-Sided|95.0|-1.08|4.11||P-value is for Urinary Irritative/Obstructive - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696856|NCT01026818|3119935|Superiority or Other||LS Mean Differences|1.56|Standard Error of the Mean|1.36||0.252|2-Sided|95.0|-1.12|4.24||P-value is for Urinary Irritative/Obstructive - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696857|NCT01026818|3119935|Superiority or Other||LS Mean Differences|1.02|Standard Error of the Mean|1.29||0.429|2-Sided|95.0|-1.52|3.56||P-value is for Urinary Irritative/Obstructive - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696858|NCT01026818|3119935|Superiority or Other||LS Mean Differences|1.57|Standard Error of the Mean|1.32||0.236|2-Sided|95.0|-1.03|4.17||P-value is for Urinary Irritative/Obstructive - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696859|NCT01026818|3119935|Superiority or Other||LS Mean Differences|0.1|Standard Error of the Mean|2.7||0.971|2-Sided|95.0|-5.21|5.41||P-value is for Urinary Incontinence - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696860|NCT01026818|3119935|Superiority or Other||LS Mean Differences|1.98|Standard Error of the Mean|2.76||0.474|2-Sided|95.0|-3.45|7.4||P-value is for Urinary Incontinence - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696861|NCT01026818|3119935|Superiority or Other||LS Mean Differences|0.53|Standard Error of the Mean|2.65||0.841|2-Sided|95.0|-4.69|5.75||P-value is for Urinary Incontinence - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696862|NCT01026818|3119935|Superiority or Other||LS Mean Differences|3.49|Standard Error of the Mean|2.7||0.196|2-Sided|95.0|-1.82|8.8||P-value is for Urinary Incontinence - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696863|NCT01026818|3119939|Superiority or Other||LS Mean Differences|-1.88|Standard Error of the Mean|3.61||0.603||95.0|-8.99|5.24|||ANCOVA|ANCOVA model included treatment, baseline, age group, and country.|||
1696864|NCT01026818|3119939|Superiority or Other||LS Mean Differences|-5.12|Standard Error of the Mean|3.66||0.162|2-Sided|95.0|-12.32|2.08|||ANCOVA|ANCOVA model included treatment, baseline, age group, and country.|||
1696865|NCT01026818|3119940|Superiority or Other||LS Mean Differences|5.59|Standard Error of the Mean|6.01||0.353|2-Sided|95.0|-6.23|17.4||P-value is for Q5 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696866|NCT01026818|3119940|Superiority or Other||LS Mean Differences|11.44|Standard Error of the Mean|6.09||0.061|2-Sided|95.0|-0.54|23.41||P-value is for Q5 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696867|NCT01026818|3119940|Superiority or Other||LS Mean Differences|-8.59|Standard Error of the Mean|4.52||0.058|2-Sided|95.0|-17.48|0.3||P-value is for Q5 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696868|NCT01026818|3119940|Superiority or Other||LS Mean Differences|-2.85|Standard Error of the Mean|4.61||0.537|2-Sided|95.0|-11.92|6.22||P-value is for Q5 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696869|NCT01026818|3119940|Superiority or Other||LS Mean Differences|3.69|Standard Error of the Mean|4.47||0.41|2-Sided|95.0|-5.11|12.49||P-value is for Q5 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696870|NCT01026818|3119940|Superiority or Other||LS Mean Differences|11.38|Standard Error of the Mean|4.58||0.013||95.0|2.38|20.38||P-value is for Q5 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696871|NCT01026818|3119940|Superiority or Other||LS Mean Differences|5.06|Standard Error of the Mean|6.05||0.403|2-Sided|95.0|-6.83|16.95||P-value is for Q4 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696872|NCT01026818|3119940|Superiority or Other||LS Mean Differences|11.52|Standard Error of the Mean|6.13||0.061|2-Sided|95.0|-0.53|23.57||P-value is for Q4 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696873|NCT01026818|3119940|Superiority or Other||LS Mean Differences|-7.14|Standard Error of the Mean|4.66||0.126|2-Sided|95.0|-16.3|2.02||P-value is for Q4 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696874|NCT01026818|3119940|Superiority or Other||LS Mean Differences|-1.94|Standard Error of the Mean|4.75||0.684|2-Sided|95.0|-11.28|7.41||P-value is for Q4 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696875|NCT01026818|3119940|Superiority or Other||LS Mean Differences|3.85|Standard Error of the Mean|4.51||0.394|2-Sided|95.0|-5.03|12.72||P-value is for Q4 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696876|NCT01026818|3119940|Superiority or Other||LS Mean Differences|11.87|Standard Error of the Mean|4.61||0.011|2-Sided|95.0|2.79|20.94||P-value is for Q4 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696877|NCT01026818|3119940|Superiority or Other||LS Mean Differences|5.09|Standard Error of the Mean|6.23||0.415|2-Sided|95.0|-7.17|17.34||P-value is for Q3 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696878|NCT01026818|3119940|Superiority or Other||LS Mean Differences|11.67|Standard Error of the Mean|6.32||0.066|2-Sided|95.0|-0.76|24.09||P-value is for Q3 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696879|NCT01026818|3119940|Superiority or Other||LS Mean Differences|-5.51|Standard Error of the Mean|5.62||0.327|2-Sided|95.0|-16.55|5.54||P-value is for Q3 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1697892|NCT01020435|3120647|Other||Mean Difference (Final Values)|-0.3|||||2-Sided|95.0|-4.0|3.5||||||Wk 3 - DBP (Unadjusted)|
1696880|NCT01026818|3119940|Superiority or Other||LS Mean Differences|0.23|Standard Error of the Mean|5.73||0.968||95.0|-11.03|11.49||P-value is for Q3 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696881|NCT01026818|3119940|Superiority or Other||LS Mean Differences|2.48|Standard Error of the Mean|5.02||0.621|2-Sided|95.0|-7.38|12.35||P-value is for Q3 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696882|NCT01026818|3119940|Superiority or Other||LS Mean Differences|12.06|Standard Error of the Mean|5.13||0.019||95.0|1.98|22.15||P-value is for Q3 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696883|NCT01026818|3119940|Superiority or Other||LS Mean Differences|5.96|Standard Error of the Mean|6.07||0.326|2-Sided|95.0|-5.97|17.89||P-value is for Q2 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696884|NCT01026818|3119940|Superiority or Other||LS Mean Differences|13.36|Standard Error of the Mean|6.15||0.03|2-Sided|95.0|1.27|25.46||P-value is for Q2 - Month13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696885|NCT01026818|3119940|Superiority or Other||LS Mean Differences|-1.26|Standard Error of the Mean|6.05||0.835|2-Sided|95.0|-13.16|10.63||P-value is for Q2 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696886|NCT01026818|3119940|Superiority or Other||LS Mean Differences|4.55|Standard Error of the Mean|6.17||0.461|2-Sided|95.0|-7.58|16.68||P-value is for Q2 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696887|NCT01026818|3119940|Superiority or Other||LS Mean Differences|6.62|Standard Error of the Mean|5.3||0.212|2-Sided|95.0|-3.8|17.04||P-value is for Q2 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696888|NCT01026818|3119940|Superiority or Other||LS Mean Differences|16.33|Standard Error of the Mean|5.42||0.003|2-Sided|95.0|5.68|26.98||P-value is for Q2 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696889|NCT01026818|3119940|Superiority or Other||LS Mean Differences|4.53|Standard Error of the Mean|4.91||0.357|2-Sided|95.0|-5.12|14.17||P-value is for Q1 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696890|NCT01026818|3119940|Superiority or Other||LS Mean Differences|10.9|Standard Error of the Mean|4.96||0.029|2-Sided|95.0|1.14|20.66||P-value is for Q1 - Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696891|NCT01026818|3119940|Superiority or Other||LS Mean Differences|5.37|Standard Error of the Mean|6.03||0.373|2-Sided|95.0|-6.48|17.23||P-value is for Q1 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696892|NCT01026818|3119940|Superiority or Other||LS Mean Differences|8.91|Standard Error of the Mean|6.15||0.148|2-Sided|95.0|-3.18|21.0||P-value is for Q1 - Month 10.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696893|NCT01026818|3119940|Superiority or Other||LS Mean Differences|11.34|Standard Error of the Mean|5.45||0.038|2-Sided|95.0|0.63|22.04||P-value is for Q1 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696894|NCT01026818|3119940|Superiority or Other||LS Mean Differences|14.87|Standard Error of the Mean|5.57||0.008|2-Sided|95.0|3.92|25.83||P-value is for Q1 - Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696895|NCT01026818|3119951|Superiority or Other||LS Mean Differences|0.1|Standard Error of the Mean|0.58||0.857|2-Sided|95.0|-1.03|1.24||P-value is for self-esteem - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696896|NCT01026818|3119951|Superiority or Other||LS Mean Differences|0.06|Standard Error of the Mean|0.59||0.923|2-Sided|95.0|-1.1|1.21||P-value is for self-esteem - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696897|NCT01026818|3119951|Superiority or Other||LS Mean Differences|0.29|Standard Error of the Mean|0.54||0.598|2-Sided|95.0|-0.78|1.35||P-value is for self-esteem - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696898|NCT01026818|3119951|Superiority or Other||LS Mean Differences|0.27|Standard Error of the Mean|0.55||0.621|2-Sided|95.0|-0.81|1.36||P-value is for self-esteem - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696899|NCT01026818|3119951|Superiority or Other||LS Mean Differences|-0.04|Standard Error of the Mean|1.17||0.972|2-Sided|95.0|-2.34|2.25||P-value is for sexual relationship - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1697000|NCT01026038|3120032|Superiority or Other||GMT ratio|0.6|||||2-Sided|95.0|0.45|0.78||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1696900|NCT01026818|3119951|Superiority or Other||LS Mean Differences|0.17|Standard Error of the Mean|1.2||0.885|2-Sided|95.0|-2.18|2.53||P-value is for sexual relationship - Month 13.5|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696901|NCT01026818|3119951|Superiority or Other||LS Mean Differences|0.47|Standard Error of the Mean|1.0||0.637|2-Sided|95.0|-1.5|2.45||P-value is for sexual relationship - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696902|NCT01026818|3119951|Superiority or Other||LS Mean Differences|1.75|Standard Error of the Mean|1.02||0.086|2-Sided|95.0|-0.25|3.76||P-value is for sexual relationship - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696903|NCT01026818|3119952|Superiority or Other||LS Mean Differences|0.13|Standard Error of the Mean|0.13||0.316|2-Sided|95.0|-0.12|0.38||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696904|NCT01026818|3119952|Superiority or Other||LS Mean Differences|0.28|Standard Error of the Mean|0.13||0.035||95.0|0.02|0.54||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696905|NCT01026818|3119952|Superiority or Other||LS Mean Differences|0.23|Standard Error of the Mean|0.11||0.041|2-Sided|95.0|0.01|0.45||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696906|NCT01026818|3119952|Superiority or Other||LS Mean Differences|0.33|Standard Error of the Mean|0.12||0.005|2-Sided|95.0|0.1|0.56||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696907|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.05|Standard Error of the Mean|0.33||0.868|2-Sided|95.0|-0.59|0.7||P-value is for overall satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696908|NCT01026818|3119953|Superiority or Other||LS Mean Differences|-0.02|Standard Error of the Mean|0.34||0.955||95.0|-0.68|0.65||P-value is for overall satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696909|NCT01026818|3119953|Superiority or Other||LS Mean Differences|-0.24|Standard Error of the Mean|0.29||0.41|2-Sided|95.0|-0.82|0.34||P-value is for overall satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696910|NCT01026818|3119953|Superiority or Other||LS Mean Differences|-0.08|Standard Error of the Mean|0.3||0.792|2-Sided|95.0|-0.67|0.51||P-value is for overall satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696911|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.15|Standard Error of the Mean|0.3||0.62|2-Sided|95.0|-0.43|0.73||P-value is for overall satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696912|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.19|Standard Error of the Mean|0.3||0.532|2-Sided|95.0|-0.4|0.78||P-value is for overall satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696913|NCT01026818|3119953|Superiority or Other||LS Mean Differences|-0.06|Standard Error of the Mean|0.54||0.91|2-Sided|95.0|-1.13|1.01||P-value is for intercourse satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696914|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.56|Standard Error of the Mean|0.56||0.314|2-Sided|95.0|-0.53|1.66||P-value is for intercourse satisfaction - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696915|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.09|Standard Error of the Mean|0.52||0.863|2-Sided|95.0|-0.93|1.11||P-value is for intercourse satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696916|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.48|Standard Error of the Mean|0.53||0.359|2-Sided|95.0|-0.55|1.52||P-value is for intercourse satisfaction - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696917|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.54|Standard Error of the Mean|0.49||0.274|2-Sided|95.0|-0.43|1.51||P-value is for intercourse satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696918|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.93|Standard Error of the Mean|0.5||0.065|2-Sided|95.0|-0.06|1.92||P-value is for intercourse satisfaction - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696919|NCT01026818|3119953|Superiority or Other||LS Mean Differences|-0.06|Standard Error of the Mean|0.24||0.801|2-Sided|95.0|-0.53|0.41||P-value is for sexual desire - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1697893|NCT01020435|3120647|Other||Mean Difference (Final Values)|-0.3|||||2-Sided|95.0|-6.2|5.6||||||Wk 3 - SBP (Unadjusted)|
1696920|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.1|Standard Error of the Mean|0.24||0.691|2-Sided|95.0|-0.38|0.58||P-value is for sexual desire - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696921|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.11|Standard Error of the Mean|0.23||0.631|2-Sided|95.0|-0.34|0.55||P-value is for sexual desire - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696922|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.06|Standard Error of the Mean|0.23||0.792|2-Sided|95.0|-0.39|0.51||P-value is for sexual desire - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696923|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.01|Standard Error of the Mean|0.24||0.95|2-Sided|95.0|-0.45|0.48||P-value is for sexual desire - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696924|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.02|Standard Error of the Mean|0.24||0.95|2-Sided|95.0|-0.46|0.49||P-value is for sexual desire - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696925|NCT01026818|3119953|Superiority or Other||LS Mean Differences|-0.52|Standard Error of the Mean|0.41||0.203|2-Sided|95.0|-1.33|0.28||P-value is for orgasmic function - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696926|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.15|Standard Error of the Mean|0.42||0.728|2-Sided|95.0|-0.68|0.97||P-value is for orgasmic function - Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696927|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.0|Standard Error of the Mean|0.41||0.998|2-Sided|95.0|-0.8|0.8||P-value is for orgasmic function - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696928|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.46|Standard Error of the Mean|0.42||0.268|2-Sided|95.0|-0.36|1.28||P-value is for orgasmic function - Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696929|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.09|Standard Error of the Mean|0.38||0.821|2-Sided|95.0|-0.67|0.84||P-value is for orgasmic function - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696930|NCT01026818|3119953|Superiority or Other||LS Mean Differences|0.37|Standard Error of the Mean|0.39||0.34||95.0|-0.39|1.14||P-value is for orgasmic function - Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696931|NCT01026818|3119954|Superiority or Other||LS Mean Differences|0.81|Standard Error of the Mean|1.2||0.5|2-Sided|95.0|-1.54|3.16||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696932|NCT01026818|3119954|Superiority or Other||LS Mean Differences|1.62|Standard Error of the Mean|1.22||0.184|2-Sided|95.0|-0.78|4.03||P-value is for Month 13.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696933|NCT01026818|3119954|Superiority or Other||LS Mean Differences|-0.22|Standard Error of the Mean|1.02||0.83|2-Sided|95.0|-2.23|1.79||P-value is for Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696934|NCT01026818|3119954|Superiority or Other||LS Mean Differences|0.26|Standard Error of the Mean|1.04||0.802|2-Sided|95.0|-1.79|2.31||P-value is for Month 10.5.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696935|NCT01026818|3119954|Superiority or Other||LS Mean differences|1.59|Standard Error of the Mean|1.02||0.118|2-Sided|95.0|-0.41|3.6||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696936|NCT01026818|3119954|Superiority or Other||LS Mean Differences|2.8|Standard Error of the Mean|1.03||0.007|2-Sided|95.0|0.76|4.83||P-value is for Month 9.|Mixed Models Analysis|The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).|||
1696937|NCT01026818|3119955|Superiority or Other||Odds Ratio (OR)|1.35||||0.259|2-Sided|95.0|0.8|2.29||P-value is for Month 13.5.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.|||
1696938|NCT01026818|3119955|Superiority or Other||Odds Ratio (OR)|1.34||||0.273|2-Sided|95.0|0.79|2.28||P-value is for Month 13.5.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.|||
1696939|NCT01026818|3119955|Superiority or Other||Odds Ratio (OR)|1.5||||0.21|2-Sided|95.0|0.79|2.85||P-value is for Month 9.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.|||
1696940|NCT01026818|3119955|Superiority or Other||Odds Ratio (OR)|2.15||||0.016|2-Sided|95.0|1.16|3.99||P-value is for Month 9.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.|||
1697163|NCT01026038|3120036|Superiority or Other||||||>|0.161|||||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1696941|NCT01026818|3119956|Superiority or Other||Odds Ratio (OR)|0.89||||0.704|2-Sided|95.0|0.48|1.65||The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.|
1696942|NCT01026818|3119956|Superiority or Other||Odds Ratio (OR)|1.14||||0.675|2-Sided|95.0|0.63|2.06||The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.|Regression, Logistic|The logistic regression model included terms for treatment group, country, and age group.||A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.|
1696943|NCT01026493|3119972|Superiority or Other||Hazard Ratio (HR)|0.93||||0.93|2-Sided|95.0|0.57|1.53|||Log Rank|Two-sided test|Reference level = Arm 1/BEV-FAILURE||
1696944|NCT01026493|3119972|Superiority or Other||Hazard Ratio (HR)|0.99||||0.95|2-Sided|95.0|0.66|1.48|||Log Rank|Two-sided test|Reference level = Arm 1/BEV-NAIVE||
1696945|NCT01026402|3119993|Superiority or Other||Maximum Tolerated Dose|125.0|||||||||||||125mg twice daily intermittent dosing (2 days on, 5 days off) 29 evaluable patients||
1696946|NCT01026402|3119993|Superiority or Other||Maximum Tolerated Dose|100.0|||||||||||||100mg once daily continuous dosing 16 evaluable patients||
1696947|NCT01026402|3119993|Superiority or Other||Maximum Tolerated Dose|50.0|||||||||||||50mg twice daily continuous dosing 20 evaluable patients||
1696948|NCT01026142|3120024|Superiority||Hazard Ratio (HR)|0.82||||0.0731|2-Sided|95.0|0.65|1.02||The primary endpoint, IRF-assessed PFS, is tested at a two-sided 5% significance level.|Log Rank|Two-sided and stratified by: prior CNS disease present/absent, measurable disease at baseline, and response to trastuzumab in 1L metastatic setting.|The stratified Cox proportional hazard model will be used to estimate the HR between the two treatment arms and its 95% CI.|"The null hypothesis for the primary endpoint is that the survival distributions of IRF-assessed PFS in the two treatment groups are the same. The alternative hypothesis is that the survival distributions of IRF-assessed PFS in the treatment and the control arms are different:~H0: IRF PFS<pertuzumab> = IRF PFS<control> vs. H1: IRF PFS<pertuzumab> ≠ IRF PFS<control>"|
1696949|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-6.8|6.6||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696950|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.6|6.6||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696951|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.6|6.7||||||Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.|
1696952|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-6.5|6.7||||||Serotype 7F:Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696953|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.5|6.6||||||Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696954|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.6|6.4||||||Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.|
1696955|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-6.6|6.6||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696956|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.6|6.5||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696957|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.6|6.5||||||Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.|
1696958|NCT01026038|3120029|Superiority or Other||Percent Difference|-3.6|||||2-Sided|95.0|-12.5|3.2||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696959|NCT01026038|3120029|Superiority or Other||Percent Difference|-0.8|||||2-Sided|95.0|-4.9|5.6||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1697164|NCT01026038|3120036|Superiority or Other||||||>|0.397|||||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1696960|NCT01026038|3120029|Superiority or Other||Percent Difference|2.8|||||2-Sided|95.0|-2.0|11.3||||||Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.|
1696961|NCT01026038|3120029|Superiority or Other||Percent Difference|-1.8|||||2-Sided|95.0|-9.6|4.5||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696962|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.7|6.2||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696963|NCT01026038|3120029|Superiority or Other||Percent Difference|1.8|||||2-Sided|95.0|-1.7|9.6||||||Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.|
1696964|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-6.5|6.3||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696965|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.6|6.3||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696966|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.5|6.4||||||Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.|
1696967|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-6.7|6.5||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696968|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.6|6.4||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696969|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.5|6.7||||||Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.|
1696970|NCT01026038|3120029|Superiority or Other||Percent Difference|1.8|||||2-Sided|95.0|-4.8|9.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696971|NCT01026038|3120029|Superiority or Other||Percent Difference|0.1|||||2-Sided|95.0|-4.8|7.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696972|NCT01026038|3120029|Superiority or Other||Percent Difference|-1.7|||||2-Sided|95.0|-6.2|4.5||||||Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.|
1696973|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-6.6|6.4||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696974|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.7|6.3||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696975|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.6|6.6||||||Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.|
1696976|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-6.7|6.5||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696977|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.7|6.5||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696978|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.7|6.6||||||Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.|
1697894|NCT01020435|3120647|Other||Mean Difference (Final Values)|2.5|||||2-Sided|95.0|-0.4|5.3||||||Tx 1 - DBP (Unadjusted)|
1696979|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-6.7|6.5||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696980|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.6|6.5||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696981|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.6|6.6||||||Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.|
1696982|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-6.4|6.5||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696983|NCT01026038|3120029|Superiority or Other||Percent difference|0.0|||||2-Sided|95.0|-3.6|6.4||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696984|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.7|6.3||||||Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.|
1696985|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-6.8|6.6||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696986|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.6|6.5||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.|
1696987|NCT01026038|3120029|Superiority or Other||Percent Difference|0.0|||||2-Sided|95.0|-3.5|6.7||||||Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.|
1696988|NCT01026038|3120032|Superiority or Other||GMT ratio|0.8|||||2-Sided|95.0|0.58|1.1||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1696989|NCT01026038|3120032|Superiority or Other||GMT ratio|0.8|||||2-Sided|95.0|0.59|1.02||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1696990|NCT01026038|3120032|Superiority or Other||GMT ratio|1.0|||||2-Sided|95.0|0.74|1.28||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1696991|NCT01026038|3120032|Superiority or Other||GMT ratio|2.0|||||2-Sided|95.0|1.46|2.69||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1696992|NCT01026038|3120032|Superiority or Other||GMT ratio|1.1|||||2-Sided|95.0|0.82|1.38||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1696993|NCT01026038|3120032|Superiority or Other||GMT ratio|0.5|||||2-Sided|95.0|0.41|0.7||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1696994|NCT01026038|3120032|Superiority or Other||GMT ratio|0.9|||||2-Sided|95.0|0.63|1.39||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1696995|NCT01026038|3120032|Superiority or Other||GMT ratio|0.9|||||2-Sided|95.0|0.66|1.31||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1696996|NCT01026038|3120032|Superiority or Other||GMT ratio|1.0|||||2-Sided|95.0|0.71|1.4||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1696997|NCT01026038|3120032|Superiority or Other||GMT ratio|0.5|||||2-Sided|95.0|0.36|0.79||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1696998|NCT01026038|3120032|Superiority or Other||GMT ratio|0.6|||||2-Sided|95.0|0.45|0.87||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1696999|NCT01026038|3120032|Superiority or Other||GMT ratio|1.2|||||2-Sided|95.0|0.84|1.62||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1698317|NCT01016977|3121121|Superiority or Other|||||||0.654||||||Week 12|ANCOVA||||
1697001|NCT01026038|3120032|Superiority or Other||GMT ratio|0.8|||||2-Sided|95.0|0.66|1.06||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697002|NCT01026038|3120032|Superiority or Other||GMT ratio|1.4|||||2-Sided|95.0|1.11|1.78||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697003|NCT01026038|3120032|Superiority or Other||GMT ratio|0.2|||||2-Sided|95.0|0.12|0.22||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697004|NCT01026038|3120032|Superiority or Other||GMT ratio|0.5|||||2-Sided|95.0|0.39|0.66||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697005|NCT01026038|3120032|Superiority or Other||GMT ratio|3.1|||||2-Sided|95.0|2.4|4.06||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697006|NCT01026038|3120032|Superiority or Other||GMT ratio|0.9|||||2-Sided|95.0|0.63|1.29||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697007|NCT01026038|3120032|Superiority or Other||GMT ratio|0.9|||||2-Sided|95.0|0.67|1.23||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697008|NCT01026038|3120032|Superiority or Other||GMT ratio|1.0|||||2-Sided|95.0|0.74|1.37||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697009|NCT01026038|3120032|Superiority or Other||GMT ratio|0.9|||||2-Sided|95.0|0.56|1.44||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697010|NCT01026038|3120032|Superiority or Other||GMT ratio|0.7|||||2-Sided|95.0|0.46|1.03||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697011|NCT01026038|3120032|Superiority or Other||GMT ratio|0.8|||||2-Sided|95.0|0.51|1.15||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697012|NCT01026038|3120032|Superiority or Other||GMT ratio|0.8|||||2-Sided|95.0|0.61|1.15||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697013|NCT01026038|3120032|Superiority or Other||GMT ratio|0.9|||||2-Sided|95.0|0.7|1.2||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697014|NCT01026038|3120032|Superiority or Other||GMT ratio|1.1|||||2-Sided|95.0|0.83|1.43||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697015|NCT01026038|3120032|Superiority or Other||GMT ratio|1.0|||||2-Sided|95.0|0.73|1.46||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697016|NCT01026038|3120032|Superiority or Other||GMT ratio|0.9|||||2-Sided|95.0|0.7|1.25||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697017|NCT01026038|3120032|Superiority or Other||GMT ratio|0.9|||||2-Sided|95.0|0.67|1.21||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697018|NCT01026038|3120032|Superiority or Other||GMT ratio|0.8|||||2-Sided|95.0|0.58|1.05||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697019|NCT01026038|3120032|Superiority or Other||GMT ratio|1.0|||||2-Sided|95.0|0.76|1.27||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697020|NCT01026038|3120032|Superiority or Other||GMT ratio|1.3|||||2-Sided|95.0|0.98|1.63||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697021|NCT01026038|3120032|Superiority or Other||GMT ratio|1.1|||||2-Sided|95.0|0.79|1.59||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697022|NCT01026038|3120032|Superiority or Other||GMT ratio|0.7|||||2-Sided|95.0|0.55|1.01||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697165|NCT01026038|3120036|Superiority or Other||||||>|0.714|||||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697023|NCT01026038|3120032|Superiority or Other||GMT ratio|0.7|||||2-Sided|95.0|0.49|0.9||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697024|NCT01026038|3120032|Superiority or Other||GMT Ratio|0.9|||||2-Sided|95.0|0.69|1.3||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697025|NCT01026038|3120032|Superiority or Other||GMT Ratio|1.0|||||2-Sided|95.0|0.76|1.3||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697026|NCT01026038|3120032|Superiority or Other||GMT Ratio|1.0|||||2-Sided|95.0|0.8|1.38||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697027|NCT01026038|3120033|Superiority or Other||GMT ratio|0.2|||||2-Sided|95.0|0.05|0.85||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697028|NCT01026038|3120033|Superiority or Other||GMT ratio|1.0|||||2-Sided|95.0|0.28|3.23||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697029|NCT01026038|3120033|Superiority or Other||GMT ratio|4.8|||||2-Sided|95.0|1.35|16.98||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697030|NCT01026038|3120033|Superiority or Other||GMT ratio|0.1|||||2-Sided|95.0|0.02|0.84||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697031|NCT01026038|3120033|Superiority or Other||GMT ratio|0.2|||||2-Sided|95.0|0.03|0.74||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697032|NCT01026038|3120033|Superiority or Other||GMT ratio|1.3|||||2-Sided|95.0|0.22|7.07||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697033|NCT01026038|3120033|Superiority or Other||GMT ratio|0.1|||||2-Sided|95.0|0.02|0.78||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697034|NCT01026038|3120033|Superiority or Other||GMT ratio|2.3|||||2-Sided|95.0|0.56|9.06||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697035|NCT01026038|3120033|Superiority or Other||GMT ratio|16.5|||||2-Sided|95.0|3.56|76.14||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697036|NCT01026038|3120033|Superiority or Other||GMT ratio|0.9|||||2-Sided|95.0|0.76|1.06||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697037|NCT01026038|3120033|Superiority or Other||GMT ratio|0.9|||||2-Sided|95.0|0.79|1.03||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697038|NCT01026038|3120033|Superiority or Other||GMT ratio|1.0|||||2-Sided|95.0|0.87|1.15||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697039|NCT01026038|3120033|Superiority or Other||GMT ratio|0.5|||||2-Sided|95.0|0.2|1.45||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697040|NCT01026038|3120033|Superiority or Other||GMT ratio|1.1|||||2-Sided|95.0|0.49|2.48||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697041|NCT01026038|3120033|Superiority or Other||GMT ratio|2.0|||||2-Sided|95.0|0.85|4.9||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697042|NCT01026038|3120033|Superiority or Other||GMT ratio|0.5|||||2-Sided|95.0|0.27|0.77||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697043|NCT01026038|3120033|Superiority or Other||GMT ratio|0.6|||||2-Sided|95.0|0.38|0.88||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697044|NCT01026038|3120033|Superiority or Other||GMT ratio|1.3|||||2-Sided|95.0|0.79|1.97||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697045|NCT01026038|3120033|Superiority or Other||GMT ratio|0.3|||||2-Sided|95.0|0.06|2.08||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697046|NCT01026038|3120033|Superiority or Other||GMT ratio|0.3|||||2-Sided|95.0|0.07|1.24||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697047|NCT01026038|3120033|Superiority or Other||GMT ratio|0.9|||||2-Sided|95.0|0.17|4.17||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697048|NCT01026038|3120033|Superiority or Other||GMT ratio|1.2|||||2-Sided|95.0|0.23|6.65||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697049|NCT01026038|3120033|Superiority or Other||GMT ratio|1.2|||||2-Sided|95.0|0.31|4.84||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697050|NCT01026038|3120033|Superiority or Other||GMT ratio|1.0|||||2-Sided|95.0|0.23|4.36||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697051|NCT01026038|3120033|Superiority or Other||GMT ratio|2.7|||||2-Sided|95.0|0.48|14.92||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697052|NCT01026038|3120033|Superiority or Other||GMT ratio|0.5|||||2-Sided|95.0|0.12|2.03||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697053|NCT01026038|3120033|Superiority or Other||GMT ratio|0.2|||||2-Sided|95.0|0.04|0.8||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697054|NCT01026038|3120033|Superiority or Other||GMT ratio|0.8|||||2-Sided|95.0|0.13|5.14||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697055|NCT01026038|3120033|Superiority or Other||GMT ratio|2.0|||||2-Sided|95.0|0.45|9.05||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697056|NCT01026038|3120033|Superiority or Other||GMT ratio|2.4|||||2-Sided|95.0|0.48|12.35||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697057|NCT01026038|3120033|Superiority or Other||GMT ratio|0.7|||||2-Sided|95.0|0.11|4.43||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697058|NCT01026038|3120033|Superiority or Other||GMT ratio|0.8|||||2-Sided|95.0|0.17|3.92||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697059|NCT01026038|3120033|Superiority or Other||GMT ratio|1.2|||||2-Sided|95.0|0.23|6.25||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697060|NCT01026038|3120033|Superiority or Other||GMT ratio|0.7|||||2-Sided|95.0|0.1|5.37||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697061|NCT01026038|3120033|Superiority or Other||GMT ratio|0.7|||||2-Sided|95.0|0.15|3.72||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697062|NCT01026038|3120033|Superiority or Other||GMT ratio|1.0|||||2-Sided|95.0|0.17|5.85||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697063|NCT01026038|3120033|Superiority or Other||GMT Ratio|1.0|||||2-Sided|95.0|0.19|5.46||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697064|NCT01026038|3120033|Superiority or Other||GMT Ratio|0.2|||||2-Sided|95.0|0.04|0.64||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697065|NCT01026038|3120033|Superiority or Other||GMT Ratio|0.2|||||2-Sided|95.0|0.04|0.73||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697066|NCT01026038|3120034|Superiority or Other||GMC ratio|0.48|||||2-Sided|95.0|0.26|0.89||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697067|NCT01026038|3120034|Superiority or Other||GMC ratio|1.24|||||2-Sided|95.0|0.75|2.05||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697166|NCT01026038|3120036|Superiority or Other||||||>|0.215|||||||Fisher Exact|||Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697068|NCT01026038|3120034|Superiority or Other||GMC ratio|2.57|||||2-Sided|95.0|1.5|4.39||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697069|NCT01026038|3120034|Superiority or Other||GMC ratio|0.4|||||2-Sided|95.0|0.17|0.92||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697070|NCT01026038|3120034|Superiority or Other||GMC ratio|1.15|||||2-Sided|95.0|0.58|2.28||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697071|NCT01026038|3120034|Superiority or Other||GMC ratio|2.88|||||2-Sided|95.0|1.39|5.98||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697072|NCT01026038|3120034|Superiority or Other||GMC ratio|0.6|||||2-Sided|95.0|0.27|1.37||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697073|NCT01026038|3120034|Superiority or Other||GMC ratio|1.88|||||2-Sided|95.0|0.96|3.69||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697074|NCT01026038|3120034|Superiority or Other||GMC ratio|3.11|||||2-Sided|95.0|1.51|6.4||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697075|NCT01026038|3120034|Superiority or Other||GMC ratio|0.15|||||2-Sided|95.0|0.07|0.31||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697076|NCT01026038|3120034|Superiority or Other||GMC ratio|0.61|||||2-Sided|95.0|0.33|1.13||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697077|NCT01026038|3120034|Superiority or Other||GMC ratio|4.2|||||2-Sided|95.0|2.18|8.09||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697078|NCT01026038|3120034|Superiority or Other||GMC ratio|0.9|||||2-Sided|95.0|0.39|2.07||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697079|NCT01026038|3120034|Superiority or Other||GMC ratio|1.0|||||2-Sided|95.0|0.5|1.97||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697080|NCT01026038|3120034|Superiority or Other||GMC ratio|1.11|||||2-Sided|95.0|0.53|2.3||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697081|NCT01026038|3120034|Superiority or Other||GMC ratio|0.07|||||2-Sided|95.0|0.02|0.21||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697082|NCT01026038|3120034|Superiority or Other||GMC ratio|0.53|||||2-Sided|95.0|0.22|1.31||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697083|NCT01026038|3120034|Superiority or Other||GMC ratio|7.53|||||2-Sided|95.0|2.86|19.78||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697084|NCT01026038|3120034|Superiority or Other||GMC ratio|0.93|||||2-Sided|95.0|0.4|2.16||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697085|NCT01026038|3120034|Superiority or Other||GMC ratio|0.83|||||2-Sided|95.0|0.42|1.67||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697086|NCT01026038|3120034|Superiority or Other||GMC ratio|0.9|||||2-Sided|95.0|0.43|1.89||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697087|NCT01026038|3120034|Superiority or Other||GMC ratio|0.81|||||2-Sided|95.0|0.3|2.21||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697088|NCT01026038|3120034|Superiority or Other||GMC ratio|1.37|||||2-Sided|95.0|0.6|3.14||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697089|NCT01026038|3120034|Superiority or Other||GMC ratio|1.7|||||2-Sided|95.0|0.7|4.12||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697090|NCT01026038|3120034|Superiority or Other||GMC ratio|1.33|||||2-Sided|95.0|0.49|3.64||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697091|NCT01026038|3120034|Superiority or Other||GMC ratio|0.92|||||2-Sided|95.0|0.4|2.1||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697092|NCT01026038|3120034|Superiority or Other||GMC ratio|0.69|||||2-Sided|95.0|0.29|1.68||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697093|NCT01026038|3120034|Superiority or Other||GMC ratio|1.25|||||2-Sided|95.0|0.42|3.72||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697094|NCT01026038|3120034|Superiority or Other||GMC ratio|1.23|||||2-Sided|95.0|0.5|3.0||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697095|NCT01026038|3120034|Superiority or Other||GMC ratio|0.98|||||2-Sided|95.0|0.38|2.55||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697096|NCT01026038|3120034|Superiority or Other||GMC ratio|0.98|||||2-Sided|95.0|0.46|2.13||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697097|NCT01026038|3120034|Superiority or Other||GMC ratio|1.09|||||2-Sided|95.0|0.58|2.06||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697098|NCT01026038|3120034|Superiority or Other||GMC ratio|1.11|||||2-Sided|95.0|0.56|2.19||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697099|NCT01026038|3120034|Superiority or Other||GMC ratio|1.18|||||2-Sided|95.0|0.5|2.79||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697100|NCT01026038|3120034|Superiority or Other||GMC ratio|1.09|||||2-Sided|95.0|0.54|2.22||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697101|NCT01026038|3120034|Superiority or Other||GMC ratio|0.93|||||2-Sided|95.0|0.43|1.99||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697102|NCT01026038|3120034|Superiority or Other||GMC Ratio|1.21|||||2-Sided|95.0|0.38|3.86||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697103|NCT01026038|3120034|Superiority or Other||GMC Ratio|0.77|||||2-Sided|95.0|0.3|1.99||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697104|NCT01026038|3120034|Superiority or Other||GMC ratio|0.63|||||2-Sided|95.0|0.23|1.76||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697105|NCT01026038|3120035|Superiority or Other||GMC ratio|0.73|||||2-Sided|95.0|0.47|1.13||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697106|NCT01026038|3120035|Superiority or Other||GMC ratio|1.33|||||2-Sided|95.0|0.91|1.94||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697107|NCT01026038|3120035|Superiority or Other||GMC ratrio|1.82|||||2-Sided|95.0|1.25|2.66||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697108|NCT01026038|3120035|Superiority or Other||GMC ratio|0.27|||||2-Sided|95.0|0.19|0.4||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697109|NCT01026038|3120035|Superiority or Other||GMC ratio|0.84|||||2-Sided|95.0|0.61|1.17||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697110|NCT01026038|3120035|Superiority or Other||GMC ratio|3.11|||||2-Sided|95.0|2.23|4.33||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697111|NCT01026038|3120035|Superiority or Other||GMC ratio|0.76|||||2-Sided|95.0|0.51|1.14||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697112|NCT01026038|3120035|Superiority or Other||GMC ratio|1.64|||||2-Sided|95.0|1.16|2.3||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697167|NCT01026038|3120036|Superiority or Other||||||>|0.397|||||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697113|NCT01026038|3120035|Superiority or Other||GMC ratio|2.14|||||2-Sided|95.0|1.52|3.02||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697114|NCT01026038|3120035|Superiority or Other||GMC ratio|0.79|||||2-Sided|95.0|0.57|1.1||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697115|NCT01026038|3120035|Superiority or Other||GMC ratio|0.91|||||2-Sided|95.0|0.69|1.2||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697116|NCT01026038|3120035|Superiority or Other||GMC ratio|1.15|||||2-Sided|95.0|0.87|1.52||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697117|NCT01026038|3120035|Superiority or Other||GMC ratio|1.12|||||2-Sided|95.0|0.59|2.15||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697118|NCT01026038|3120035|Superiority or Other||GMC ratio|1.19|||||2-Sided|95.0|0.68|2.09||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697119|NCT01026038|3120035|Superiority or Other||GMC ratio|1.06|||||2-Sided|95.0|0.61|1.87||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697120|NCT01026038|3120035|Superiority or Other||GMC ratio|0.49|||||2-Sided|95.0|0.32|0.74||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697121|NCT01026038|3120035|Superiority or Other||GMC ratio|1.26|||||2-Sided|95.0|0.88|1.79||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697122|NCT01026038|3120035|Superiority or Other||GMC ratio|2.59|||||2-Sided|95.0|1.8|3.73||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697123|NCT01026038|3120035|Superiority or Other||GMC ratio|1.32|||||2-Sided|95.0|0.87|2.01||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697124|NCT01026038|3120035|Superiority or Other||GMC ratio|1.06|||||2-Sided|95.0|0.74|1.52||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697125|NCT01026038|3120035|Superiority or Other||GMC ratio|0.8|||||2-Sided|95.0|0.56|1.15||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697126|NCT01026038|3120035|Superiority or Other||GMC ratio|1.46|||||2-Sided|95.0|0.85|2.51||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697127|NCT01026038|3120035|Superiority or Other||GMC ratio|1.54|||||2-Sided|95.0|0.97|2.44||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697128|NCT01026038|3120035|Superiority or Other||GMC ratio|1.05|||||2-Sided|95.0|0.66|1.68||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697129|NCT01026038|3120035|Superiority or Other||GMC ratio|1.58|||||2-Sided|95.0|1.11|2.25||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697130|NCT01026038|3120035|Superiority or Other||GMC ratio|0.91|||||2-Sided|95.0|0.67|1.23||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697131|NCT01026038|3120035|Superiority or Other||GMC ratio|0.58|||||2-Sided|95.0|0.42|0.78||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697132|NCT01026038|3120035|Superiority or Other||GMC ratio|1.25|||||2-Sided|95.0|0.77|2.03||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697133|NCT01026038|3120035|Superiority or Other||GMC ratio|1.3|||||2-Sided|95.0|0.86|1.97||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697134|NCT01026038|3120035|Superiority or Other||GMC ratio|1.04|||||2-Sided|95.0|0.69|1.58||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697168|NCT01026038|3120036|Superiority or Other||||||>|0.714|||||||Fisher Exact|||Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697135|NCT01026038|3120035|Superiority or Other||GMC ratio|1.29|||||2-Sided|95.0|0.93|1.8||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697136|NCT01026038|3120035|Superiority or Other||GMC ratio|1.01|||||2-Sided|95.0|0.76|1.33||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697137|NCT01026038|3120035|Superiority or Other||GMC ratio|0.78|||||2-Sided|95.0|0.58|1.03||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697138|NCT01026038|3120035|Superiority or Other||GMC ratio|1.27|||||2-Sided|95.0|0.84|1.94||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697139|NCT01026038|3120035|Superiority or Other||GMC ratio|0.89|||||2-Sided|95.0|0.62|1.27||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697140|NCT01026038|3120035|Superiority or Other||GMC ratio|0.7|||||2-Sided|95.0|0.49|1.0||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697141|NCT01026038|3120035|Superiority or Other||GMC Ratio|1.29|||||2-Sided|95.0|0.92|1.79||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697142|NCT01026038|3120035|Superiority or Other||GMC Ratio|0.96|||||2-Sided|95.0|0.73|1.28||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697143|NCT01026038|3120035|Superiority or Other||GMC ratio|0.75|||||2-Sided|95.0|0.56|1.0||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697144|NCT01026038|3120036|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697145|NCT01026038|3120036|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697146|NCT01026038|3120036|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697147|NCT01026038|3120036|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697148|NCT01026038|3120036|Superiority or Other||||||>|0.092|||||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697149|NCT01026038|3120036|Superiority or Other||||||>|0.058|||||||Fisher Exact|||Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697150|NCT01026038|3120036|Superiority or Other||||||>|0.125|||||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697151|NCT01026038|3120036|Superiority or Other||||||>|0.174|||||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697152|NCT01026038|3120036|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697153|NCT01026038|3120036|Superiority or Other||||||>|0.285|||||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697154|NCT01026038|3120036|Superiority or Other||||||>|0.045|||||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697155|NCT01026038|3120036|Superiority or Other||||||>|0.237|||||||Fisher Exact|||Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697156|NCT01026038|3120036|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697157|NCT01026038|3120036|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697158|NCT01026038|3120036|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697159|NCT01026038|3120036|Superiority or Other||||||>|0.226|||||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697160|NCT01026038|3120036|Superiority or Other||||||>|0.161|||||||Fisher Exact|||Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697161|NCT01026038|3120036|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697162|NCT01026038|3120036|Superiority or Other||||||>|0.226|||||||Fisher Exact|||Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697171|NCT01026038|3120036|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Fever (>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697172|NCT01026038|3120036|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Fever (>=39 degree C to <=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697173|NCT01026038|3120036|Superiority or Other||||||>|0.608|||||||Fisher Exact|||Fever (>=39 degree C to <=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697174|NCT01026038|3120036|Superiority or Other||||||>|0.592|||||||Fisher Exact|||Fever (>=39 degree C to <=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697175|NCT01026038|3120036|Superiority or Other||||||>|0.628|||||||Fisher Exact|||Fever (>=38 degree C to <=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC|
1697176|NCT01026038|3120036|Superiority or Other||||||>|0.345|||||||Fisher Exact|||Fever (>=38 degree C to <=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC|
1697177|NCT01026038|3120036|Superiority or Other||||||>|0.075|||||||Fisher Exact|||Fever (>=38 degree C to <=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC|
1697178|NCT01026038|3120037|Superiority or Other|||||||0.489|||||||Fisher Exact|||Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697179|NCT01026038|3120037|Superiority or Other|||||||0.323|||||||Fisher Exact|||Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697180|NCT01026038|3120037|Superiority or Other|||||||0.517|||||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697181|NCT01026038|3120037|Superiority or Other|||||||0.145|||||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697182|NCT01026038|3120037|Superiority or Other|||||||0.297|||||||Fisher Exact|||Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697183|NCT01026038|3120037|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697184|NCT01026038|3120037|Superiority or Other||||||>|0.836|||||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697185|NCT01026038|3120037|Superiority or Other||||||>|0.859|||||||Fisher Exact|||Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697186|NCT01026038|3120037|Superiority or Other||||||>|0.864|||||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697187|NCT01026038|3120037|Superiority or Other||||||>|0.549|||||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697188|NCT01026038|3120037|Superiority or Other||||||>|0.607|||||||Fisher Exact|||Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697189|NCT01026038|3120037|Superiority or Other||||||>|0.489|||||||Fisher Exact|||Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697190|NCT01026038|3120037|Superiority or Other||||||>|0.323|||||||Fisher Exact|||Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697191|NCT01026038|3120037|Superiority or Other||||||>|0.074|||||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697192|NCT01026038|3120037|Superiority or Other||||||>|0.253|||||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697193|NCT01026038|3120037|Superiority or Other||||||>|0.671|||||||Fisher Exact|||Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697194|NCT01026038|3120037|Superiority or Other||||||>|0.687|||||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697195|NCT01026038|3120037|Superiority or Other||||||>|0.261|||||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697196|NCT01026038|3120037|Superiority or Other||||||>|0.443|||||||Fisher Exact|||Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697197|NCT01026038|3120037|Superiority or Other||||||>|0.198|||||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697198|NCT01026038|3120037|Superiority or Other||||||>|0.197|||||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697199|NCT01026038|3120037|Superiority or Other||||||>|0.859|||||||Fisher Exact|||Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697200|NCT01026038|3120037|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697201|NCT01026038|3120037|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697202|NCT01026038|3120037|Superiority or Other||||||>|0.544|||||||Fisher Exact|||Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697203|NCT01026038|3120037|Superiority or Other||||||>|0.658|||||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697204|NCT01026038|3120037|Superiority or Other||||||>|0.633|||||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697205|NCT01026038|3120037|Superiority or Other||||||>|0.376|||||||Fisher Exact|||Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697206|NCT01026038|3120037|Superiority or Other||||||>|0.499|||||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697207|NCT01026038|3120037|Superiority or Other||||||>|0.552|||||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697208|NCT01026038|3120037|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697209|NCT01026038|3120037|Superiority or Other||||||>|0.314|||||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697210|NCT01026038|3120037|Superiority or Other||||||>|0.429|||||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.|
1697211|NCT01026038|3120037|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.|
1697212|NCT01026038|3120038|Superiority or Other||GMC ratio|0.52|||||2-Sided|95.0|0.38|0.72||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697213|NCT01026038|3120038|Superiority or Other||GMC ratio|1.04|||||2-Sided|95.0|0.79|1.37||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697214|NCT01026038|3120038|Superiority or Other||GMC ratio|1.99|||||2-Sided|95.0|1.51|2.63||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697215|NCT01026038|3120038|Superiority or Other||GMC ratio|0.63|||||2-Sided|95.0|0.47|0.83||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697216|NCT01026038|3120038|Superiority or Other||GMC ratio|1.03|||||2-Sided|95.0|0.81|1.3||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697217|NCT01026038|3120038|Superiority or Other||GMC ratio|1.63|||||2-Sided|95.0|1.28|2.08||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697218|NCT01026038|3120038|Superiority or Other||GMC ratio|0.77|||||2-Sided|95.0|0.53|1.13||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697219|NCT01026038|3120038|Superiority or Other||GMC ratio|1.24|||||2-Sided|95.0|0.89|1.72||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697220|NCT01026038|3120038|Superiority or Other||GMC ratio|1.61|||||2-Sided|95.0|1.15|2.23||||||Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697221|NCT01026038|3120038|Superiority or Other||GMC ratio|0.15|||||2-Sided|95.0|0.11|0.2||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697222|NCT01026038|3120038|Superiority or Other||GMC ratio|0.52|||||2-Sided|95.0|0.4|0.68||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697223|NCT01026038|3120038|Superiority or Other||GMC ratio|3.49|||||2-Sided|95.0|2.68|4.54||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697224|NCT01026038|3120038|Superiority or Other||GMC ratio|0.77|||||2-Sided|95.0|0.52|1.15||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697225|NCT01026038|3120038|Superiority or Other||GMC ratio|0.87|||||2-Sided|95.0|0.62|1.23||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697226|NCT01026038|3120038|Superiority or Other||GMC ratio|1.13|||||2-Sided|95.0|0.8|1.59||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697285|NCT01025752|3120064|Other||Mean Difference (Final Values)|-0.94||||0.17|2-Sided|95.0|-2.28|0.4|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)|
1697227|NCT01026038|3120038|Superiority or Other||GMC ratio|0.14|||||2-Sided|95.0|0.1|0.2||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697228|NCT01026038|3120038|Superiority or Other||GMC ratio|0.52|||||2-Sided|95.0|0.4|0.68||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697229|NCT01026038|3120038|Superiority or Other||GMC ratio|3.62|||||2-Sided|95.0|2.76|4.74||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697230|NCT01026038|3120038|Superiority or Other||GMC ratio|1.19|||||2-Sided|95.0|0.87|1.64||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697231|NCT01026038|3120038|Superiority or Other||GMC ratio|0.95|||||2-Sided|95.0|0.73|1.25||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697232|NCT01026038|3120038|Superiority or Other||GMC ratio|0.8|||||2-Sided|95.0|0.61|1.05||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697233|NCT01026038|3120038|Superiority or Other||GMC ratio|0.8|||||2-Sided|95.0|0.54|1.19||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697234|NCT01026038|3120038|Superiority or Other||GMC ratio|1.1|||||2-Sided|95.0|0.78|1.55||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697235|NCT01026038|3120038|Superiority or Other||GMC ratio|1.37|||||2-Sided|95.0|0.97|1.94||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697236|NCT01026038|3120038|Superiority or Other||GMCratio|1.14|||||2-Sided|95.0|0.84|1.56||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697237|NCT01026038|3120038|Superiority or Other||GMC ratio|0.85|||||2-Sided|95.0|0.65|1.11||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697238|NCT01026038|3120038|Superiority or Other||GMC ratio|0.75|||||2-Sided|95.0|0.57|0.97||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697239|NCT01026038|3120038|Superiority or Other||GMC ratio|1.02|||||2-Sided|95.0|0.74|1.4||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697240|NCT01026038|3120038|Superiority or Other||GMC ratio|1.04|||||2-Sided|95.0|0.79|1.37||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697241|NCT01026038|3120038|Superiority or Other||GMC ratio|1.02|||||2-Sided|95.0|0.77|1.34||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697242|NCT01026038|3120038|Superiority or Other||GMC ratio|1.05|||||2-Sided|95.0|0.79|1.39||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697243|NCT01026038|3120038|Superiority or Other||GMC ratio|1.09|||||2-Sided|95.0|0.86|1.39||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697244|NCT01026038|3120038|Superiority or Other||GMC ratio|1.04|||||2-Sided|95.0|0.82|1.32||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697245|NCT01026038|3120038|Superiority or Other||GMC ratio|1.44|||||2-Sided|95.0|1.02|2.04||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697246|NCT01026038|3120038|Superiority or Other||GMC ratio|0.89|||||2-Sided|95.0|0.66|1.2||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697247|NCT01026038|3120038|Superiority or Other||GMC ratio|0.62|||||2-Sided|95.0|0.46|0.84||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697248|NCT01026038|3120038|Superiority or Other||GMC Ratio|1.42|||||2-Sided|95.0|1.03|1.96||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697286|NCT01025752|3120065|Other||Mean Difference (Final Values)|-0.74||||0.68|2-Sided|95.0|-4.3|2.83|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)|
1697249|NCT01026038|3120038|Superiority or Other||GMC Ratio|1.15|||||2-Sided|95.0|0.87|1.52||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).|
1697250|NCT01026038|3120038|Superiority or Other||GMC ratio|0.81|||||2-Sided|95.0|0.61|1.07||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).|
1697251|NCT01025830|3120045|Non-Inferiority or Equivalence|Same for all three drugs.|Geometric Mean Ratio|0.8||||||90.0|0.63|0.98|||||Same for all three drugs.|Same for all three drugs.|
1697252|NCT01025830|3120045|Non-Inferiority or Equivalence|same for all three drugs.|Geometric Mean Ratio|1.1||||||90.0|0.95|1.23|||||Same for all three drugs.|Same for all three drugs.|
1697253|NCT01025830|3120045|Non-Inferiority or Equivalence|same as for AUC|Geometric Mean Ratio|1.3||||||90.0|0.99|1.71|||||same as AUC|Same as for AUC|
1697254|NCT01025830|3120046|Non-Inferiority or Equivalence|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|0.8||||||90.0|0.65|0.99|||||the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.|
1697255|NCT01025830|3120046|Non-Inferiority or Equivalence|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|1.1||||||90.0|0.95|1.31|||||the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.|
1697256|NCT01025830|3120046|Non-Inferiority or Equivalence|Bioequivalence was defined as a 90% Confidence Interval of the geometric mean ratio between 0.8 and 1.25. Differences between treatments with respect to the outcome and intra- and inter-subject variances were assessed using the mixed effects model. Bootstrapped random errors were used.|Geometric Mean Ratio|1.1||||||90.0|0.87|1.38|||||the generic is the numerator while the brand is the denominator|The null hypothesis was that there is a difference in the relative bioavailability of Triomune and brand-name stavudine/lamivudine/nevirapine in HIV-infected Africans. 18 participants were required to provide 80% power to detect approximately a 20% difference on a log scale in AUC0-12h between the brand formulation and the generic formulation. Alpha level of 0.05.|
1697257|NCT01025791|3120054|Other||1 mg + 1 mg + 0.6 mg vs. placebo|4.24||||0.163|2-Sided|95.0|-3.03|11.52|||ANOVA||||
1697258|NCT01025791|3120054|Other||1 mg + 0.6 mg + 0.6 mg vs. placebo|3.48||||0.214|2-Sided|90.0|-3.94|10.9|||ANOVA||||
1697259|NCT01025791|3120054|Other||1.2 mg + 1.0 mg vs. placebo|5.74||||0.098|2-Sided|90.0|-1.68|13.16|||ANOVA||||
1697260|NCT01025791|3120054|Other||1.0 mg + 0.8 mg vs. placebo|9.16||||0.022|2-Sided|90.0|1.74|16.58|||ANOVA||||
1697261|NCT01025791|3120054|Other||1.2 mg + 0.6 mg vs. placebo|3.38||||0.195|2-Sided|90.0|-3.29|10.06|||ANOVA||||
1697262|NCT01025791|3120054|Other||1.2 mg vs. placebo|4.54||||0.1|2-Sided|90.0|-1.94|11.02|||ANOVA||||
1697263|NCT01025791|3120054|Other||0.4 mg vs. placebo|0.85||||0.399|2-Sided|90.0|-4.79|6.48|||ANOVA||||
1697264|NCT01025791|3120054|Other||1 mg + 0.8 mg vs. placebo|4.39||||0.0211|2-Sided|90.0|0.89|7.09|||ANOVA||||
1697265|NCT01025791|3120054|Other||1 mg vs. placebo|7.08|||<|0.001|2-Sided|90.0|3.69|10.47|||ANOVA||||
1697266|NCT01025791|3120054|Other||0.5mg vs. placebo|-2.96|||<|0.0741|2-Sided|90.0|-6.35|0.43|||ANOVA||||
1697267|NCT01025791|3120054|Other||0.2 mg vs. placebo|2.33|||<|0.1329|2-Sided|90.0|-1.17|5.83|||ANOVA||||
1697268|NCT01025791|3120054|Other||0.1 mg vs placebo|-0.53|||<|0.396|2-Sided|90.0|-3.92|2.86|||ANOVA||||
1697269|NCT01025791|3120055|Other||GMR (Fed/fasted)|0.97|||||2-Sided|95.0|0.79|1.19|||||||
1697270|NCT01025791|3120056|Other||GMR (Fed/Fasted)|0.89|||||2-Sided|95.0|0.86|0.92|||||||
1697271|NCT01025791|3120061|Other||1 mg + 1 mg + 0.6 mg vs. placebo|-9.0||||0.002|2-Sided|95.0|-13.8|-4.17|||ANOVA||||
1697272|NCT01025791|3120061|Other||1.0 mg + 0.6 mg + 0.6 mg vs. placebo|-9.96||||0.001|2-Sided|90.0|-14.9|-5.02|||ANOVA||||
1697273|NCT01025791|3120061|Other||1.2 mg + 1.0 mg vs. placebo|-6.45||||0.017|2-Sided|90.0|-11.4|-1.51|||ANOVA||||
1697274|NCT01025791|3120061|Other||1 mg + 0.8 mg vs. placebo|-9.31||||0.001|2-Sided|90.0|-14.2|-4.37|||ANOVA||||
1697275|NCT01025791|3120061|Other||1.2 mg + 0.6 mg vs. placebo|-1.43||||0.314|2-Sided|90.0|-6.5|3.63|||ANOVA||||
1697276|NCT01025791|3120061|Other||1.2 mg vs. placebo|1.24||||0.333|2-Sided|90.0|-3.67|6.15|||ANOVA||||
1697277|NCT01025791|3120061|Other||0.4 mg vs. placebo|2.22||||0.191|2-Sided|90.0|-2.09|6.54|||ANOVA||||
1697278|NCT01025791|3120061|Other||1 mg + 0.8 mg vs. placebo|-3.97||||0.059|2-Sided|90.0|-8.16|0.22|||ANOVA||||
1697279|NCT01025791|3120061|Other||1 mg vs. placebo|-5.69||||0.012|2-Sided|90.0|-9.74|-1.63|||ANOVA||||
1697280|NCT01025791|3120061|Other||0.5 mg vs. placebo|0.01||||0.498|2-Sided|90.0|-4.05|4.06|||ANOVA||||
1697281|NCT01025791|3120061|Other||0.2 mg vs. placebo|-1.23||||0.31|2-Sided|90.0|-5.42|2.96|||ANOVA||||
1697282|NCT01025791|3120061|Other||0.1 mg vs. placebo|-7.06||||0.003|2-Sided|90.0|-11.1|-3.0|||ANOVA||||
1697283|NCT01025752|3120064|Other||Mean Difference (Final Values)|0.37||||0.64|2-Sided|95.0|-1.22|1.97|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)|
1697284|NCT01025752|3120064|Other||Mean Difference (Final Values)|-0.12||||0.86|2-Sided|95.0|-1.39|1.16|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)|
1697287|NCT01025752|3120065|Other||Mean Difference (Final Values)|-1.27||||0.4|2-Sided|95.0|-4.27|1.73|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)|
1697288|NCT01025752|3120065|Other||Mean Difference (Final Values)|0.24||||0.85|2-Sided|95.0|-2.32|2.8|||Mixed Models Analysis|||post-treatment (12 weeks time point). (Mean difference of IVR CBT- F2F CBT)|
1697289|NCT01025752|3120066|Other||Mean Difference (Final Values)|2.43||||0.16|2-Sided|95.0|-0.96|5.82|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)|
1697290|NCT01025752|3120066|Other||Mean Difference (Final Values)|0.38||||0.81|2-Sided|95.0|-2.82|3.58|||Mixed Models Analysis|||3 months post-baseline. (Mean difference of IVR CBT- F2F CBT)|
1697291|NCT01025752|3120066|Other||Mean Difference (Final Values)|1.25||||0.4|2-Sided|95.0|-1.66|4.16|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)|
1697292|NCT01025752|3120067|Other||Mean Difference (Final Values)|-0.58||||0.68|2-Sided|95.0|-3.4|2.24|||Mixed Models Analysis|||6 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)|
1697293|NCT01025752|3120067|Other||Mean Difference (Final Values)|1.15||||0.42|2-Sided|95.0|-1.68|3.98|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)|
1697294|NCT01025752|3120067|Other||Mean Difference (Final Values)|0.29||||0.83|2-Sided|95.0|-2.3|2.87|||Mixed Models Analysis|||post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)|
1697295|NCT01025752|3120068|Other||Mean Difference (Final Values)|-0.61||||0.51|2-Sided|95.0|-2.42|1.2|||Mixed Models Analysis|||6 months post-baseline time point|
1697296|NCT01025752|3120068|Other||Mean Difference (Final Values)|-1.53||||0.12|2-Sided|95.0|-3.46|0.41|||Mixed Models Analysis|||3 months post-baseline time point|
1697297|NCT01025752|3120068|Other||Mean Difference (Final Values)|-0.5||||0.58|2-Sided|95.0|-2.29|1.29|||Mixed Models Analysis|||post-treatment (12 weeks) time point|
1697298|NCT01025752|3120069|Other||Mean Difference (Final Values)|-0.02||||0.93|2-Sided|95.0|-0.57|0.52|||Mixed Models Analysis|||6 months post baseline time point. (Mean difference of IVR CBT- F2F CBT)|
1697299|NCT01025752|3120069|Other||Mean Difference (Final Values)|-0.34||||0.2|2-Sided|95.0|-0.87|0.18|||Mixed Models Analysis|||3 months post-baseline time point. (Mean difference of IVR CBT- F2F CBT)|
1697300|NCT01025752|3120069|Other||Mean Difference (Final Values)|-0.33||||0.12|2-Sided|95.0|-0.74|0.09|||Mixed Models Analysis|||Post-treatment (12 weeks) time point. (Mean difference of IVR CBT- F2F CBT)|
1697301|NCT01025752|3120070|Non-Inferiority|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|-0.08||||0.004|2-Sided|95.0|-0.86|0.71||The non-inferiority margin is 1.|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA & back pain cause)|The upper limit (0.71) fell below the non-inferiority margin of 1.|6 month post- baseline time point.|
1697302|NCT01025752|3120070|Non-Inferiority|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|-0.23|||<|0.0001|2-Sided|95.0|-0.94|0.49||Non-inferiority margin of 1|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA & back pain cause)|The upper limit (0.49) fell below the non-inferiority margin of 1.|3 month post-baseline time point|
1697303|NCT01025752|3120070|Non-Inferiority|A 20% (1.4) reduction in NRS for pain intensity from baseline was considered minimally clinically important the non-inferiority margin was set at one NRS unit. The required sample size was 230 participants. Because enrollment was slower than expected and the standard deviation in the primary outcome was less than the initial power calculation (1.6 vs. 2.45) we conducted a sample size recalculation, based on observed data to determine that we would need 42 completers per arm for 80% power.|Mean Difference (Final Values)|0.07|||<|0.007|2-Sided|95.0|-0.67|0.8||Non-inferiority margin of 1|Mixed Models Analysis|The models includes treatment arm, time, treatment-by-time interaction, baseline NRS, stratification variables (distance from VA & back pain cause)|The upper limit (0.80) fell below the non-inferiority margin of 1.|post-treatment (12 weeks) time point|
1697304|NCT01025635|3120073|Superiority or Other (legacy)||||||<|0.001|||||||ANCOVA|with factors treatment group, study center, and baseline lesion count as covariate|||
1697305|NCT01025635|3120074|Superiority or Other (legacy)|||||||0.017|||||||Cochran-Mantel-Haenszel|study center adjusted|||
1697306|NCT01025336|3120081|Superiority or Other||Ratio|1.9|||||2-Sided|95.0|1.27|2.97|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 23F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale|
1697307|NCT01025336|3120081|Superiority or Other||Ratio|1.3|||||2-Sided|95.0|0.89|2.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 19F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale|
1697308|NCT01025336|3120081|Superiority or Other||Ratio|1.5|||||2-Sided|95.0|1.1|2.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 19A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale|
1697328|NCT01025336|3120082|Superiority or Other||Ratio|1.0|||||2-Sided|95.0|0.71|1.53|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 5: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.|
1697309|NCT01025336|3120081|Superiority or Other||Ratio|1.6|||||2-Sided|95.0|1.09|2.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 18C: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale|
1697310|NCT01025336|3120081|Superiority or Other||Ratio|0.9|||||2-Sided|95.0|0.58|1.4|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 14: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale|
1697311|NCT01025336|3120081|Superiority or Other||Ratio|1.4|||||2-Sided|95.0|0.83|2.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 9V: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale|
1697312|NCT01025336|3120081|Superiority or Other||Ratio|1.0|||||2-Sided|95.0|0.58|1.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 7F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale|
1697313|NCT01025336|3120081|Superiority or Other||Ratio|2.3|||||2-Sided|95.0|1.4|3.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 6B: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale|
1697314|NCT01025336|3120081|Superiority or Other||Ratio|4.8|||||2-Sided|95.0|3.05|7.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 6A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale|
1697315|NCT01025336|3120081|Superiority or Other||Ratio|1.4|||||2-Sided|95.0|0.95|1.96|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 5: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale|
1697316|NCT01025336|3120081|Superiority or Other||Ratio|1.8|||||2-Sided|95.0|1.09|3.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 4: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale|
1697317|NCT01025336|3120081|Superiority or Other||Ratio|1.0|||||2-Sided|95.0|0.76|1.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 3: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale|
1697318|NCT01025336|3120081|Superiority or Other||Ratio|1.6|||||2-Sided|95.0|1.15|2.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 1: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale|
1697319|NCT01025336|3120082|Superiority or Other||Ratio|3.0|||||2-Sided|95.0|1.97|4.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 23F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.|
1697320|NCT01025336|3120082|Superiority or Other||Ratio|1.2|||||2-Sided|95.0|0.77|1.78|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 19F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.|
1697321|NCT01025336|3120082|Superiority or Other||Ratio|1.4|||||2-Sided|95.0|1.01|1.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 19A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.|
1697322|NCT01025336|3120082|Superiority or Other||Ratio|1.4|||||2-Sided|95.0|0.92|2.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 18C: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.|
1697323|NCT01025336|3120082|Superiority or Other||Ratio|0.8|||||2-Sided|95.0|0.54|1.28|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 14: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.|
1697324|NCT01025336|3120082|Superiority or Other||Ratio|1.6|||||2-Sided|95.0|0.96|2.77|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 9V: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.|
1697325|NCT01025336|3120082|Superiority or Other||Ratio|2.0|||||2-Sided|95.0|1.22|3.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 7F: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.|
1697326|NCT01025336|3120082|Superiority or Other||Ratio|2.6|||||2-Sided|95.0|1.61|4.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 6B: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.|
1697327|NCT01025336|3120082|Superiority or Other||Ratio|7.3|||||2-Sided|95.0|4.67|11.44|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 6A: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.|
1697329|NCT01025336|3120082|Superiority or Other||Ratio|1.9|||||2-Sided|95.0|1.25|2.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 4: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.|
1697330|NCT01025336|3120082|Superiority or Other||Ratio|0.8|||||2-Sided|95.0|0.63|1.08|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 3: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.|
1697331|NCT01025336|3120082|Superiority or Other||Ratio|1.2|||||2-Sided|95.0|0.87|1.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the measures [(13vPnC - 23vPS)].|Serotype 1: Ratio of GMT (13vPnC to 23vPS) was calculated by back transforming the mean difference between vaccine group on the logarithmic scale.|
1697332|NCT01025336|3120083|Superiority or Other||geometric mean fold rise|1.7|||||2-Sided|95.0|1.44|2.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697333|NCT01025336|3120083|Superiority or Other||geometric mean fold rise|2.2|||||2-Sided|95.0|1.8|2.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697334|NCT01025336|3120083|Superiority or Other||geometric mean fold rise|1.3|||||2-Sided|95.0|1.14|1.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697335|NCT01025336|3120083|Superiority or Other||geometric mean fold rise|1.3|||||2-Sided|95.0|1.1|1.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697336|NCT01025336|3120083|Superiority or Other||geometric mean fold rise|1.6|||||2-Sided|95.0|1.33|1.86|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697337|NCT01025336|3120083|Superiority or Other||geometric mean fold rise|1.9|||||2-Sided|95.0|1.37|2.61|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697338|NCT01025336|3120083|Superiority or Other||geometric mean fold rise|2.6|||||2-Sided|95.0|1.98|3.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697339|NCT01025336|3120083|Superiority or Other||geometric mean fold rise|1.3|||||2-Sided|95.0|1.05|1.53|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697340|NCT01025336|3120083|Superiority or Other||geometric mean fold rise|0.9|||||2-Sided|95.0|0.79|1.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697341|NCT01025336|3120083|Superiority or Other||geometric mean fold rise|1.8|||||2-Sided|95.0|1.55|2.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697342|NCT01025336|3120083|Superiority or Other||geometric mean fold rise|2.1|||||2-Sided|95.0|1.6|2.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697343|NCT01025336|3120083|Superiority or Other||geometric mean fold rise|1.2|||||2-Sided|95.0|1.07|1.37|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697344|NCT01025336|3120083|Superiority or Other||geometric mean fold rise|1.2|||||2-Sided|95.0|1.03|1.31|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697345|NCT01025336|3120084|Superiority or Other||Ratio of GMT|0.8|||||2-Sided|95.0|0.5|1.15|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC-13vPnC)].|Serotype 23F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697346|NCT01025336|3120084|Superiority or Other||Ratio of GMT|1.4|||||2-Sided|95.0|0.93|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC-13vPnC)].|Serotype 19F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697895|NCT01020435|3120647|Other||Mean Difference (Final Values)|4.1|||||2-Sided|95.0|-0.9|9.2||||||Tx 1 - SBP (Unadjusted)|
1697347|NCT01025336|3120084|Superiority or Other||Ratio of GMT|1.0|||||2-Sided|95.0|0.75|1.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC-13vPnC)].|Serotype 19A: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697348|NCT01025336|3120084|Superiority or Other||Ratio of GMT|0.8|||||2-Sided|95.0|0.57|1.19|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC-13vPnC)].|Serotype 18C: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697349|NCT01025336|3120084|Superiority or Other||Ratio of GMT|1.9|||||2-Sided|95.0|1.26|2.87|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC-13vPnC)].|Serotype 14: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697350|NCT01025336|3120084|Superiority or Other||Ratio of GMT|1.7|||||2-Sided|95.0|1.01|2.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC-13vPnC)].|Serotype 9V: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697351|NCT01025336|3120084|Superiority or Other||Ratio of GMT|1.9|||||2-Sided|95.0|1.14|3.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC-13vPnC)].|Serotype 7F: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697352|NCT01025336|3120084|Superiority or Other||Ratio of GMT|1.0|||||2-Sided|95.0|0.64|1.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC-13vPnC)].|Serotype 6B: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697353|NCT01025336|3120084|Superiority or Other||Ratio of GMT|0.4|||||2-Sided|95.0|0.27|0.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC-13vPnC)].|Serotype 6A: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697354|NCT01025336|3120084|Superiority or Other||Ratio of GMT|1.4|||||2-Sided|95.0|0.93|1.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC-13vPnC)].|Serotype 5: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697355|NCT01025336|3120084|Superiority or Other||Ratio of GMT|1.4|||||2-Sided|95.0|0.88|2.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC-13vPnC)].|Serotype 4: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697356|NCT01025336|3120084|Superiority or Other||Ratio of GMT|1.0|||||2-Sided|95.0|0.76|1.28|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC-13vPnC)].|Serotype 3: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697357|NCT01025336|3120084|Superiority or Other||Ratio of GMT|0.7|||||2-Sided|95.0|0.48|0.92|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC-13vPnC)].|Serotype 1: Ratio of GMT (23vPS/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697358|NCT01025336|3120085|Superiority or Other||geometric mean fold rise|1.1|||||2-Sided|95.0|0.89|1.48|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697359|NCT01025336|3120085|Superiority or Other||geometric mean fold rise|2.1|||||2-Sided|95.0|1.56|2.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697360|NCT01025336|3120085|Superiority or Other||geometric mean fold rise|1.2|||||2-Sided|95.0|1.07|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697361|NCT01025336|3120085|Superiority or Other||geometric mean fold rise|1.0|||||2-Sided|95.0|0.82|1.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697362|NCT01025336|3120085|Superiority or Other||geometric mean fold rise|1.6|||||2-Sided|95.0|1.23|2.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697363|NCT01025336|3120085|Superiority or Other||geometric mean fold rise|2.1|||||2-Sided|95.0|1.48|2.95|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697711|NCT01024608|3120155|Superiority or Other||LS mean treatment diff from placebo|-0.48||||0.005|2-Sided|95.0|-0.8|-0.1||A priori threshold for statistical significance is p<0.05|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.|||
1697364|NCT01025336|3120085|Superiority or Other||geometric mean fold rise|1.7|||||2-Sided|95.0|1.24|2.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697365|NCT01025336|3120085|Superiority or Other||geometric mean fold rise|1.7|||||2-Sided|95.0|1.32|2.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697366|NCT01025336|3120085|Superiority or Other||geometric mean fold rise|0.6|||||2-Sided|95.0|0.48|0.79|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697367|NCT01025336|3120085|Superiority or Other||geometric mean fold rise|0.8|||||2-Sided|95.0|0.67|0.87|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697368|NCT01025336|3120085|Superiority or Other||geometric mean fold rise|0.5|||||2-Sided|95.0|0.41|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697369|NCT01025336|3120085|Superiority or Other||geometric mean fold rise|1.0|||||2-Sided|95.0|0.82|1.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697370|NCT01025336|3120085|Superiority or Other||geometric mean fold rise|1.0|||||2-Sided|95.0|0.85|1.22|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697371|NCT01025336|3120086|Superiority or Other||Ratio of GMT|0.4|||||2-Sided|95.0|0.26|0.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC - 13vPnC)].|Serotype 23F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697372|NCT01025336|3120086|Superiority or Other||Ratio of GMT|1.3|||||2-Sided|95.0|0.89|1.98|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC - 13vPnC)].|Serotype 19F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697373|NCT01025336|3120086|Superiority or Other||Ratio of GMT|0.8|||||2-Sided|95.0|0.62|1.08|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC - 13vPnC)].|Serotype 19A: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697374|NCT01025336|3120086|Superiority or Other||Ratio of GMT|0.8|||||2-Sided|95.0|0.52|1.14|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC - 13vPnC)].|Serotype 18C: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697375|NCT01025336|3120086|Superiority or Other||Ratio of GMT|1.5|||||2-Sided|95.0|1.02|2.3|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC - 13vPnC)].|Serotype 14: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697376|NCT01025336|3120086|Superiority or Other||Ratio of GMT|1.5|||||2-Sided|95.0|0.9|2.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC - 13vPnC)].|Serotype 9V: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697377|NCT01025336|3120086|Superiority or Other||Ratio of GMT|1.1|||||2-Sided|95.0|0.68|1.76|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC - 13vPnC)].|Serotype 7F: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697378|NCT01025336|3120086|Superiority or Other||Ratio of GMT|0.8|||||2-Sided|95.0|0.49|1.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC - 13vPnC)].|Serotype 6B: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697379|NCT01025336|3120086|Superiority or Other||Ratio of GMT|0.2|||||2-Sided|95.0|0.11|0.26|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC - 13vPnC)].|Serotype 6A: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697380|NCT01025336|3120086|Superiority or Other||Ratio of GMT|0.9|||||2-Sided|95.0|0.59|1.26|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC - 13vPnC)].|Serotype 5: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697712|NCT01024608|3120156|Superiority or Other||LS mean treatment diff from placebo|-0.92|||<|0.001|2-Sided|95.0|-1.3|-0.5||A priori threshold for statistical significance is p<0.05|ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.|||
1697381|NCT01025336|3120086|Superiority or Other||Ratio of GMT|0.3|||||2-Sided|95.0|0.2|0.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC - 13vPnC)].|Serotype 4: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697382|NCT01025336|3120086|Superiority or Other||Ratio of GMT|0.8|||||2-Sided|95.0|0.64|1.09|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC - 13vPnC)].|Serotype 3: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697383|NCT01025336|3120086|Superiority or Other||Ratio of GMT|0.7|||||2-Sided|95.0|0.48|0.9|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(23vPS/13vPnC - 13vPnC)].|Serotype 1: Ratio of GMT (23vPs/13vPnC to 13vPnC) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697384|NCT01025336|3120087|Superiority or Other||Ratio of GMT|2.1|||||2-Sided|95.0|1.37|3.37|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS - 23vPS)]|Serotype 23F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697385|NCT01025336|3120087|Superiority or Other||Ratio of GMT|3.4|||||2-Sided|95.0|2.3|5.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS - 23vPS)]|Serotype 19F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697386|NCT01025336|3120087|Superiority or Other||Ratio of GMT|2.0|||||2-Sided|95.0|1.5|2.78|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS - 23vPS)]|Serotype 19A: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697387|NCT01025336|3120087|Superiority or Other||Ratio of GMT|1.7|||||2-Sided|95.0|1.06|2.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS - 23vPS)]|Serotype 18C: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697388|NCT01025336|3120087|Superiority or Other||Ratio of GMT|1.4|||||2-Sided|95.0|0.89|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS - 23vPS)]|Serotype 14: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697389|NCT01025336|3120087|Superiority or Other||Ratio of GMT|4.2|||||2-Sided|95.0|2.43|7.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS - 23vPS)]|Serotype 9V: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697390|NCT01025336|3120087|Superiority or Other||Ratio of GMT|6.2|||||2-Sided|95.0|3.85|9.98|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS - 23vPS)]|Serotype 7F: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697391|NCT01025336|3120087|Superiority or Other||Ratio of GMT|3.7|||||2-Sided|95.0|2.25|5.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS - 23vPS)]|Serotype 6B: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697392|NCT01025336|3120087|Superiority or Other||Ratio of GMT|2.7|||||2-Sided|95.0|1.66|4.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS - 23vPS)]|Serotype 6A: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697393|NCT01025336|3120087|Superiority or Other||Ratio of GMT|1.5|||||2-Sided|95.0|1.03|2.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS - 23vPS)]|Serotype 5: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697394|NCT01025336|3120087|Superiority or Other||Ratio of GMT|1.1|||||2-Sided|95.0|0.68|1.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS - 23vPS)]|Serotype 4: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697395|NCT01025336|3120087|Superiority or Other||Ratio of GMT|1.0|||||2-Sided|95.0|0.77|1.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS - 23vPS)]|Serotype 3: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697396|NCT01025336|3120087|Superiority or Other||Ratio of GMT|1.1|||||2-Sided|95.0|0.8|1.63|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS - 23vPS)]|Serotype 1: Ratio of GMT (13vPnC/23vPS to 23vPS) was calculated by back transforming the mean difference between vaccine sequence/group on the logarithmic scale.|
1697397|NCT01025336|3120088|Superiority or Other||Ratio of GMT|2.3|||||2-Sided|95.0|1.54|3.42|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale|
1697398|NCT01025336|3120088|Superiority or Other||Ratio of GMT|1.8|||||2-Sided|95.0|1.21|2.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale|
1697399|NCT01025336|3120088|Superiority or Other||Ratio of GMT|1.3|||||2-Sided|95.0|0.97|1.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale|
1697400|NCT01025336|3120088|Superiority or Other||Ratio of GMT|1.5|||||2-Sided|95.0|1.06|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale|
1697401|NCT01025336|3120088|Superiority or Other||Ratio of GMT|0.8|||||2-Sided|95.0|0.57|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale|
1697402|NCT01025336|3120088|Superiority or Other||Ratio of GMT|1.2|||||2-Sided|95.0|0.7|1.99|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale|
1697403|NCT01025336|3120088|Superiority or Other||Ratio of GMT|1.5|||||2-Sided|95.0|0.95|2.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale|
1697404|NCT01025336|3120088|Superiority or Other||Ratio of GMT|1.3|||||2-Sided|95.0|0.88|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale|
1697405|NCT01025336|3120088|Superiority or Other||Ratio of GMT|2.2|||||2-Sided|95.0|1.42|3.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale|
1697406|NCT01025336|3120088|Superiority or Other||Ratio of GMT|1.4|||||2-Sided|95.0|0.95|1.97|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale|
1697407|NCT01025336|3120088|Superiority or Other||Ratio of GMT|1.5|||||2-Sided|95.0|1.03|2.29|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale|
1697408|NCT01025336|3120088|Superiority or Other||Ratio of GMT|1.2|||||2-Sided|95.0|0.95|1.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale|
1697409|NCT01025336|3120088|Superiority or Other||Ratio of GMT|1.7|||||2-Sided|95.0|1.27|2.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale|
1697410|NCT01025336|3120089|Superiority or Other||Ratio of GMT|1.7|||||2-Sided|95.0|1.05|2.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 13vPnC/23vPS)]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697411|NCT01025336|3120089|Superiority or Other||Ratio of GMT|0.6|||||2-Sided|95.0|0.41|0.88|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 13vPnC/23vPS)]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697412|NCT01025336|3120089|Superiority or Other||Ratio of GMT|0.8|||||2-Sided|95.0|0.58|1.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 13vPnC/23vPS)]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697413|NCT01025336|3120089|Superiority or Other||Ratio of GMT|0.7|||||2-Sided|95.0|0.48|1.17|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 13vPnC/23vPS)]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697713|NCT01024608|3120157|Superiority or Other||LS mean treatment diff from placebo|-0.91|||<|0.001|2-Sided|95.0|-1.3|-0.5||A priori threshold for statistical significance is p<0.05.|ANCOVA|Repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.|||
1697414|NCT01025336|3120089|Superiority or Other||Ratio of GMT|0.9|||||2-Sided|95.0|0.59|1.41|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 13vPnC/23vPS)]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697415|NCT01025336|3120089|Superiority or Other||Ratio of GMT|1.0|||||2-Sided|95.0|0.54|1.7|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 13vPnC/23vPS)]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697416|NCT01025336|3120089|Superiority or Other||Ratio of GMT|0.6|||||2-Sided|95.0|0.37|0.97|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 13vPnC/23vPS)]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697417|NCT01025336|3120089|Superiority or Other||Ratio of GMT|1.3|||||2-Sided|95.0|0.82|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 13vPnC/23vPS)]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697418|NCT01025336|3120089|Superiority or Other||Ratio of GMT|1.4|||||2-Sided|95.0|0.85|2.32|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 13vPnC/23vPS)]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697419|NCT01025336|3120089|Superiority or Other||Ratio of GMT|0.4|||||2-Sided|95.0|0.25|0.59|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 13vPnC/23vPS)]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697420|NCT01025336|3120089|Superiority or Other||Ratio of GMT|0.9|||||2-Sided|95.0|0.58|1.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 13vPnC/23vPS)]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697421|NCT01025336|3120089|Superiority or Other||Ratio of GMT|0.7|||||2-Sided|95.0|0.52|0.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 13vPnC/23vPS)]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697422|NCT01025336|3120089|Superiority or Other||Ratio of GMT|1.0|||||2-Sided|95.0|0.72|1.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 13vPnC/23vPS)]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 13vPnC/23vPS) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697423|NCT01025336|3120090|Superiority or Other||Ratio of GMT|3.1|||||2-Sided|95.0|1.89|5.2|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 23F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697424|NCT01025336|3120090|Superiority or Other||Ratio of GMT|1.3|||||2-Sided|95.0|0.84|2.06|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 19F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697425|NCT01025336|3120090|Superiority or Other||Ratio of GMT|1.4|||||2-Sided|95.0|1.01|2.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 19A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697426|NCT01025336|3120090|Superiority or Other||Ratio of GMT|1.2|||||2-Sided|95.0|0.71|1.93|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 18C: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697427|NCT01025336|3120090|Superiority or Other||Ratio of GMT|1.0|||||2-Sided|95.0|0.64|1.54|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 14: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697428|NCT01025336|3120090|Superiority or Other||Ratio of GMT|1.6|||||2-Sided|95.0|0.88|3.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 9V: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697429|NCT01025336|3120090|Superiority or Other||Ratio of GMT|1.7|||||2-Sided|95.0|0.96|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 7F: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697714|NCT01024569|3120158|Superiority||MIXREG Estimate|0.39|Standard Error of the Mean|0.11||0.001|2-Sided||||||Mixed Effects Random Regression||||
1697715|NCT01024569|3120159|Superiority||MIXREG Estimate|1.06|Standard Error of the Mean|0.52||0.042|2-Sided||||||Mixed Effects Random Regression||||
1697430|NCT01025336|3120090|Superiority or Other||Ratio of GMT|2.4|||||2-Sided|95.0|1.43|4.11|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 6B: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697431|NCT01025336|3120090|Superiority or Other||Ratio of GMT|3.1|||||2-Sided|95.0|1.82|5.24|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 6A: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697432|NCT01025336|3120090|Superiority or Other||Ratio of GMT|0.7|||||2-Sided|95.0|0.41|1.04|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 5: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697433|NCT01025336|3120090|Superiority or Other||Ratio of GMT|1.8|||||2-Sided|95.0|1.06|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 4: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697434|NCT01025336|3120090|Superiority or Other||Ratio of GMT|1.1|||||2-Sided|95.0|0.78|1.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 3: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697435|NCT01025336|3120090|Superiority or Other||Ratio of GMT|1.5|||||2-Sided|95.0|1.02|2.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/13vPnC - 23vPS/13vPnC)]|Serotype 1: Ratio of GMT (13vPnC/13vPnC to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697436|NCT01025336|3120091|Superiority or Other||Ratio|1.8|||||2-Sided|95.0|1.18|2.82|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS-23vPS/13vPnC)].|Serotype 23F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697437|NCT01025336|3120091|Superiority or Other||Ratio|2.2|||||2-Sided|95.0|1.53|3.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS-23vPS/13vPnC)].|Serotype 19F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697438|NCT01025336|3120091|Superiority or Other||Ratio|1.8|||||2-Sided|95.0|1.38|2.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS-23vPS/13vPnC)].|Serotype 19A: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697439|NCT01025336|3120091|Superiority or Other||Ratio|1.6|||||2-Sided|95.0|1.02|2.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS-23vPS/13vPnC)].|Serotype 18C: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697440|NCT01025336|3120091|Superiority or Other||Ratio|1.1|||||2-Sided|95.0|0.73|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS-23vPS/13vPnC)].|Serotype 14: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697441|NCT01025336|3120091|Superiority or Other||Ratio|1.7|||||2-Sided|95.0|0.99|2.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS-23vPS/13vPnC)].|Serotype 9V: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697442|NCT01025336|3120091|Superiority or Other||Ratio|2.8|||||2-Sided|95.0|1.8|4.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS-23vPS/13vPnC)].|Serotype 7F: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697443|NCT01025336|3120091|Superiority or Other||Ratio|1.8|||||2-Sided|95.0|1.15|2.91|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS-23vPS/13vPnC)].|Serotype 6B: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697444|NCT01025336|3120091|Superiority or Other||Ratio|2.2|||||2-Sided|95.0|1.36|3.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS-23vPS/13vPnC)].|Serotype 6A: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697445|NCT01025336|3120091|Superiority or Other||Ratio|1.7|||||2-Sided|95.0|1.15|2.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS-23vPS/13vPnC)].|Serotype 5: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697446|NCT01025336|3120091|Superiority or Other||Ratio|1.9|||||2-Sided|95.0|1.22|3.06|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS-23vPS/13vPnC)].|Serotype 4: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697447|NCT01025336|3120091|Superiority or Other||Ratio|1.5|||||2-Sided|95.0|1.14|1.99|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC/23vPS-23vPS/13vPnC)].|Serotype 3: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697448|NCT01025336|3120091|Superiority or Other||Ratio of GMT|1.5|||||2-Sided|95.0|1.02|2.08|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [13vPnC/23vPS-23vPS/13vPnC)].|Serotype 1: Ratio of GMT (13vPnC/23vPS to 23vPS/13vPnC) was calculated by back transforming the mean difference between vaccine sequence on the logarithmic scale.|
1697449|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|2.8|||||2-Sided|95.0|2.24|3.4|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697450|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|6.9|||||2-Sided|95.0|5.16|9.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697451|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|4.0|||||2-Sided|95.0|3.13|5.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697452|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|5.9|||||2-Sided|95.0|4.55|7.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697453|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|2.7|||||2-Sided|95.0|2.24|3.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697454|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|3.0|||||2-Sided|95.0|2.46|3.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697455|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|2.5|||||2-Sided|95.0|2.06|3.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697456|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|4.1|||||2-Sided|95.0|3.16|5.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697457|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|2.8|||||2-Sided|95.0|2.23|3.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697458|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|2.9|||||2-Sided|95.0|2.26|3.71|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697459|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|2.9|||||2-Sided|95.0|2.1|4.04|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697460|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|3.6|||||2-Sided|95.0|2.5|5.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697461|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|5.6|||||2-Sided|95.0|4.07|7.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697462|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|7.4|||||2-Sided|95.0|5.23|10.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697463|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|3.1|||||2-Sided|95.0|2.32|4.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697464|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|6.5|||||2-Sided|95.0|4.61|9.03|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697716|NCT01024569|3120160|Superiority||MIXREG Estimate|0.05|Standard Error of the Mean|0.02||0.029|2-Sided||||||Mixed Effects Random Regression||||
1697465|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|3.5|||||2-Sided|95.0|2.59|4.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697466|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|11.9|||||2-Sided|95.0|8.56|16.49|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697467|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|3.1|||||2-Sided|95.0|2.58|3.79|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697468|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|4.9|||||2-Sided|95.0|3.96|6.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697469|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|5.9|||||2-Sided|95.0|4.25|8.21|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697470|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|8.0|||||2-Sided|95.0|5.82|11.09|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697471|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|1.5|||||2-Sided|95.0|1.32|1.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697472|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|2.1|||||2-Sided|95.0|1.83|2.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697473|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|2.3|||||2-Sided|95.0|1.92|2.81|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697474|NCT01025336|3120092|Superiority or Other||geometric mean fold rise|3.7|||||2-Sided|95.0|3.05|4.49|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697475|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|4.7|||||2-Sided|95.0|3.52|6.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697476|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|6.7|||||2-Sided|95.0|5.02|8.92|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697477|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|12.0|||||2-Sided|95.0|7.89|18.19|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697478|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|11.5|||||2-Sided|95.0|8.01|16.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697479|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|17.2|||||2-Sided|95.0|12.77|23.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697480|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|12.2|||||2-Sided|95.0|8.05|18.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697481|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|7.6|||||2-Sided|95.0|5.86|9.94|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697482|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|13.0|||||2-Sided|95.0|10.21|16.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697717|NCT01024569|3120161|Superiority||MIXREG Estimate|0.4|Standard Error of the Mean|2.37||0.02|2-Sided||||||Mixed Effects Random Regression|||Mixed Effects Random Regression analysis was used to assess the effects of study condition on Hope outcomes.|
1697483|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|12.0|||||2-Sided|95.0|8.82|16.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697484|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|9.8|||||2-Sided|95.0|7.07|13.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697485|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|22.3|||||2-Sided|95.0|16.5|30.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697486|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|20.0|||||2-Sided|95.0|12.99|30.76|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697487|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|8.0|||||2-Sided|95.0|5.75|11.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697488|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|11.5|||||2-Sided|95.0|8.15|16.23|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697489|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|12.8|||||2-Sided|95.0|8.16|20.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697490|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|6.8|||||2-Sided|95.0|4.54|10.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697491|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|12.6|||||2-Sided|95.0|8.56|18.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697492|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|12.8|||||2-Sided|95.0|7.79|21.13|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697493|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|19.4|||||2-Sided|95.0|12.95|29.17|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697494|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|47.2|||||2-Sided|95.0|34.0|65.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697495|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|32.2|||||2-Sided|95.0|19.75|52.57|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697496|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|11.1|||||2-Sided|95.0|7.24|17.01|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697497|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|21.4|||||2-Sided|95.0|14.56|31.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697498|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|20.8|||||2-Sided|95.0|12.59|34.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697499|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|6.5|||||2-Sided|95.0|4.29|9.89|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697500|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|12.3|||||2-Sided|95.0|8.66|17.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697718|NCT01024569|3120162|Superiority||MIXREG Estimate|-1.16|Standard Error of the Mean|-2.21||0.027|2-Sided||||||Mixed Effects Random Regression||||
1698318|NCT01016977|3121121|Superiority or Other|||||||0.3644||||||Week 8|ANCOVA||||
1697501|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|15.1|||||2-Sided|95.0|9.56|23.81|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697502|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|7.5|||||2-Sided|95.0|5.59|10.02|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697503|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|12.6|||||2-Sided|95.0|9.71|16.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697504|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|6.2|||||2-Sided|95.0|4.35|8.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697505|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|5.5|||||2-Sided|95.0|3.71|8.07|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697506|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|9.0|||||2-Sided|95.0|6.26|12.92|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697507|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|12.9|||||2-Sided|95.0|7.8|21.34|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697508|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|2.6|||||2-Sided|95.0|2.2|3.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697509|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|4.4|||||2-Sided|95.0|3.67|5.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697510|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|3.2|||||2-Sided|95.0|2.59|3.91|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697511|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|4.8|||||2-Sided|95.0|3.71|6.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697512|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|8.3|||||2-Sided|95.0|6.65|10.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697513|NCT01025336|3120093|Superiority or Other||geometric mean fold rise|8.0|||||2-Sided|95.0|6.05|10.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697514|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.9|||||2-Sided|95.0|0.75|1.15|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697515|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.6|||||2-Sided|95.0|0.51|0.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697516|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.7|||||2-Sided|95.0|0.53|0.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697517|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.7|||||2-Sided|95.0|0.59|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697518|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.9|||||2-Sided|95.0|0.78|1.05|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697719|NCT01024309|3120171|Superiority or Other|||||||0.49||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcox Rank Sum Test|||
1697519|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.6|||||2-Sided|95.0|0.54|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697520|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.7|||||2-Sided|95.0|0.56|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697521|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.6|||||2-Sided|95.0|0.5|0.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697522|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.8|||||2-Sided|95.0|0.71|1.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697523|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.9|||||2-Sided|95.0|0.72|1.01|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697524|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.7|||||2-Sided|95.0|0.47|0.98|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697525|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.3|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697526|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.6|||||2-Sided|95.0|0.43|0.77|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697527|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.5|||||2-Sided|95.0|0.37|0.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697528|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.9|||||2-Sided|95.0|0.66|1.09|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697529|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.34|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697530|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|1.1|||||2-Sided|95.0|0.81|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697531|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.3|||||2-Sided|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697532|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|1.0|||||2-Sided|95.0|0.86|1.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697533|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.7|||||2-Sided|95.0|0.6|0.82|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697534|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.9|||||2-Sided|95.0|0.64|1.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697535|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.5|||||2-Sided|95.0|0.42|0.68|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697536|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.3|||||2-Sided|95.0|0.26|0.37|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697720|NCT01024309|3120172|Superiority or Other|||||||0.23||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used|||
1697537|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.33|0.44|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697538|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.36|0.48|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697539|NCT01025336|3120094|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.36|0.5|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697540|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.5|||||2-Sided|95.0|0.42|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697541|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.2|||||2-Sided|95.0|0.15|0.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697542|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.3|||||2-Sided|95.0|0.23|0.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697543|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.34|0.54|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697544|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.5|||||2-Sided|95.0|0.39|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697545|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.5|||||2-Sided|95.0|0.35|0.58|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697546|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.36|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697547|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.35|0.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697548|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.3|||||2-Sided|95.0|0.3|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697549|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.29|0.45|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697550|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.3|||||2-Sided|95.0|0.28|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697551|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.3|||||2-Sided|95.0|0.2|0.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697552|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.5|||||2-Sided|95.0|0.42|0.65|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697553|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.6|||||2-Sided|95.0|0.49|0.74|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697554|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.6|||||2-Sided|95.0|0.48|0.83|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697721|NCT01024309|3120173|Superiority or Other|||||||0.29||||||a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum|||
1697555|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.28|0.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697556|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.3|||||2-Sided|95.0|0.2|0.39|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697557|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.2|||||2-Sided|95.0|0.13|0.28|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697558|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.27|0.56|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697559|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.3|||||2-Sided|95.0|0.21|0.36|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697560|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.3|||||2-Sided|95.0|0.17|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697561|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.29|0.59|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697562|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.29|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697563|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.5|||||2-Sided|95.0|0.4|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697564|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.3|||||2-Sided|95.0|0.22|0.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697565|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.1|||||2-Sided|95.0|0.06|0.1|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697566|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.1|||||2-Sided|95.0|0.08|0.14|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697567|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.3|||||2-Sided|95.0|0.25|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697568|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.3|||||2-Sided|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697569|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.2|||||2-Sided|95.0|0.13|0.22|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697570|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.1|||||2-Sided|95.0|0.1|0.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697571|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.2|||||2-Sided|95.0|0.12|0.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697572|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.1|||||2-Sided|95.0|0.1|0.18|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697722|NCT01024309|3120174|Superiority or Other|||||||0.13||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used|||
1697573|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.2|||||2-Sided|95.0|0.18|0.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697574|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.31|0.42|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697575|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.2|||||2-Sided|95.0|0.2|0.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697576|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.2|||||2-Sided|95.0|0.2|0.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697577|NCT01025336|3120095|Superiority or Other||Geometric mean fold rise|0.2|||||2-Sided|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697578|NCT01025336|3120095|Superiority or Other||geometric mean fold rise|0.2|||||2-Sided|95.0|0.19|0.29|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 1 and 1 Year Postvaccination 2 blood draws.|
1697579|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.5|||||2-Sided|95.0|1.24|1.84|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697580|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.7|||||2-Sided|95.0|1.44|2.06|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697581|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.9|||||2-Sided|95.0|1.53|2.31|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697582|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|2.2|||||2-Sided|95.0|1.8|2.6|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697583|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.5|||||2-Sided|95.0|1.28|1.67|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697584|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.3|||||2-Sided|95.0|1.14|1.43|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697585|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.3|||||2-Sided|95.0|1.14|1.55|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697586|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.3|||||2-Sided|95.0|1.1|1.42|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697587|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.7|||||2-Sided|95.0|1.38|2.01|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697588|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.6|||||2-Sided|95.0|1.33|1.86|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697589|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|2.4|||||2-Sided|95.0|1.76|3.38|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697723|NCT01024309|3120175|Superiority or Other|||||||0.0029||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used|||
1698319|NCT01016977|3121121|Superiority or Other|||||||0.8234||||||Week 4|ANCOVA||||
1697590|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.9|||||2-Sided|95.0|1.37|2.61|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697591|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.7|||||2-Sided|95.0|1.31|2.18|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697592|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|2.6|||||2-Sided|95.0|1.98|3.5|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697593|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.9|||||2-Sided|95.0|1.5|2.51|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697594|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.3|||||2-Sided|95.0|1.05|1.53|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697595|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.9|||||2-Sided|95.0|1.48|2.55|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697596|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|0.9|||||2-Sided|95.0|0.79|1.07|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697597|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.8|||||2-Sided|95.0|1.54|2.09|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697598|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.8|||||2-Sided|95.0|1.55|2.03|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697599|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|2.4|||||2-Sided|95.0|1.82|3.24|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697600|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|2.1|||||2-Sided|95.0|1.6|2.68|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697601|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.0|||||2-Sided|95.0|0.91|1.13|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697602|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.2|||||2-Sided|95.0|1.07|1.37|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697603|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.0|||||2-Sided|95.0|0.91|1.16|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697604|NCT01025336|3120096|Superiority or Other||Geometric mean fold rise|1.2|||||2-Sided|95.0|1.03|1.31|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697605|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.2|||||2-Sided|95.0|0.99|1.51|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697606|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|0.7|||||2-Sided|95.0|0.63|0.85|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697724|NCT01024309|3120176|Superiority or Other|||||||0.22||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used|||
1697607|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.1|||||2-Sided|95.0|0.89|1.48|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697608|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.5|||||2-Sided|95.0|1.18|1.9|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697609|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|2.3|||||2-Sided|95.0|1.82|2.88|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697610|NCT01025336|3120097|Superiority or Other||Geometric mean fold rises|2.1|||||2-Sided|95.0|1.56|2.8|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 19F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697611|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.1|||||2-Sided|95.0|0.96|1.27|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697612|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.4|||||2-Sided|95.0|1.24|1.61|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697613|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.2|||||2-Sided|95.0|1.07|1.46|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697614|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.0|||||2-Sided|95.0|0.89|1.2|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697615|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.1|||||2-Sided|95.0|0.96|1.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697616|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.0|||||2-Sided|95.0|0.82|1.19|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697617|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.2|||||2-Sided|95.0|1.04|1.42|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697618|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.4|||||2-Sided|95.0|1.18|1.78|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697619|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.6|||||2-Sided|95.0|1.23|2.05|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697620|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|2.9|||||2-Sided|95.0|1.99|4.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697621|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|2.7|||||2-Sided|95.0|1.97|3.7|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697622|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|2.1|||||2-Sided|95.0|1.48|2.95|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697623|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|2.0|||||2-Sided|95.0|1.53|2.75|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697725|NCT01024309|3120177|Superiority or Other|||||||0.04||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test was used|||
1697624|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|3.1|||||2-Sided|95.0|2.26|4.3|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697625|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.7|||||2-Sided|95.0|1.24|2.26|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697626|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.6|||||2-Sided|95.0|1.2|2.01|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697627|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.4|||||2-Sided|95.0|1.14|1.6|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697628|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.7|||||2-Sided|95.0|1.32|2.19|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697629|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.3|||||2-Sided|95.0|0.94|1.75|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697630|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.32|0.46|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697631|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|0.6|||||2-Sided|95.0|0.48|0.79|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697632|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|0.9|||||2-Sided|95.0|0.75|1.02|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697633|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.1|||||2-Sided|95.0|0.96|1.3|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697634|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|0.8|||||2-Sided|95.0|0.67|0.87|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697635|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|0.6|||||2-Sided|95.0|0.47|0.76|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697636|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|0.7|||||2-Sided|95.0|0.6|0.82|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697637|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|0.5|||||2-Sided|95.0|0.41|0.69|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697638|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|0.7|||||2-Sided|95.0|0.62|0.81|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697639|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.1|||||2-Sided|95.0|0.98|1.32|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697640|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|1.0|||||2-Sided|95.0|0.82|1.1|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697726|NCT01024309|3120178|Superiority or Other|||||||0.08||||||the a priori threshold for statistical significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test|||
1698320|NCT01016977|3121121|Superiority or Other|||||||0.2895||||||Week 2|ANCOVA||||
1697641|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|0.8|||||2-Sided|95.0|0.69|0.9|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697642|NCT01025336|3120097|Superiority or Other||Geometric mean fold rise|0.9|||||2-Sided|95.0|0.79|1.02|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697643|NCT01025336|3120097|Superiority or Other||geometric mean fold rise|1.0|||||2-Sided|95.0|0.85|1.22|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the Prevaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697644|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.34|0.48|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697645|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.3|||||2-Sided|95.0|0.27|0.37|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 23F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697646|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.9|||||2-Sided|95.0|0.75|1.05|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697647|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.8|||||2-Sided|95.0|0.66|0.93|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697648|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.7|||||2-Sided|95.0|0.65|0.79|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697649|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.6|||||2-Sided|95.0|0.57|0.72|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697650|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.7|||||2-Sided|95.0|0.59|0.83|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697651|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.5|||||2-Sided|95.0|0.48|0.62|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697652|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|1.2|||||2-Sided|95.0|1.04|1.43|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697653|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|1.0|||||2-Sided|95.0|0.85|1.09|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697654|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.8|||||2-Sided|95.0|0.57|1.12|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697655|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.5|||||2-Sided|95.0|0.37|0.67|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697656|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.9|||||2-Sided|95.0|0.67|1.13|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697727|NCT01024309|3120179|Superiority or Other|||||||0.04||||||Apriori level of significance was 0.05|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum was used|||
1697985|NCT01018732|3120810|Superiority or Other||ratio of titer|50.0|||||2-Sided|95.0|26.0|94.0||||||Day 8, Men W-135, Pairwise comparison of geometric mean titer|
1697657|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.7|||||2-Sided|95.0|0.58|0.96|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 7F: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697658|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.5|||||2-Sided|95.0|0.4|0.59|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697659|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.31|0.45|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697660|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.2|||||2-Sided|95.0|0.19|0.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations|Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697661|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.2|||||2-Sided|95.0|0.19|0.29|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697662|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.9|||||2-Sided|95.0|0.74|0.99|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697663|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.9|||||2-Sided|95.0|0.81|1.08|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697664|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.8|||||2-Sided|95.0|0.63|0.97|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697665|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.7|||||2-Sided|95.0|0.6|0.85|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697666|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.5|||||2-Sided|95.0|0.44|0.57|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697667|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.4|||||2-Sided|95.0|0.35|0.45|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697668|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.6|||||2-Sided|95.0|0.56|0.72|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697669|NCT01025336|3120098|Superiority or Other||Geometric mean fold rise|0.5|||||2-Sided|95.0|0.42|0.56|||||Confidence intervals (CIs) are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rises (GMFRs) were calculated using all subjects with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697670|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.3|||||2-Sided|95.0|0.28|0.43|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697671|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.3|||||2-Sided|95.0|0.23|0.35|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697672|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.2|||||2-Sided|95.0|0.15|0.26|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 23F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697673|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.7|||||2-Sided|95.0|0.63|0.88|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697674|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.5|||||2-Sided|95.0|0.44|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697675|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.5|||||2-Sided|95.0|0.42|0.64|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697676|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.6|||||2-Sided|95.0|0.53|0.66|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697677|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.6|||||2-Sided|95.0|0.52|0.63|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697678|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.6|||||2-Sided|95.0|0.49|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 19A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697679|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.6|||||2-Sided|95.0|0.53|0.69|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697680|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.5|||||2-Sided|95.0|0.39|0.56|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697681|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.4|||||2-Sided|95.0|0.29|0.51|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 18C: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697682|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.9|||||2-Sided|95.0|0.78|1.06|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697683|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.6|||||2-Sided|95.0|0.54|0.75|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697684|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.9|||||2-Sided|95.0|0.71|1.08|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 14: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697685|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|1.1|||||2-Sided|95.0|0.78|1.67|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697686|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.5|||||2-Sided|95.0|0.39|0.73|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697687|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.6|||||2-Sided|95.0|0.41|0.8|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 9V: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697688|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|1.1|||||2-Sided|95.0|0.86|1.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697689|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.6|||||2-Sided|95.0|0.51|0.75|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697690|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.8|||||2-Sided|95.0|0.6|1.0|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 7F: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697691|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.5|||||2-Sided|95.0|0.38|0.59|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697881|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.842|2-Sided|95.0|-0.75|0.61|||Mixed Models Analysis|||Statistical analysis of Week 1.|
1697692|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.5|||||2-Sided|95.0|0.43|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697693|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.5|||||2-Sided|95.0|0.41|0.62|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6B: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697694|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.1|||||2-Sided|95.0|0.09|0.16|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697695|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.2|||||2-Sided|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697696|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.1|||||2-Sided|95.0|0.1|0.2|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 6A: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697697|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.5|||||2-Sided|95.0|0.44|0.6|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697698|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.3|||||2-Sided|95.0|0.27|0.38|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697699|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.3|||||2-Sided|95.0|0.25|0.39|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 5: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697700|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.2|||||2-Sided|95.0|0.17|0.3|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697701|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.3|||||2-Sided|95.0|0.22|0.33|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697702|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.2|||||2-Sided|95.0|0.19|0.32|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 4: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697703|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.4|||||2-Sided|95.0|0.31|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697704|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.2|||||2-Sided|95.0|0.18|0.24|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697705|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.2|||||2-Sided|95.0|0.17|0.25|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 3: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697706|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.5|||||2-Sided|95.0|0.44|0.61|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697707|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.3|||||2-Sided|95.0|0.3|0.41|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: GMFR was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697708|NCT01025336|3120099|Superiority or Other||geometric mean fold rise|0.4|||||2-Sided|95.0|0.32|0.46|||||CIs for the GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.|Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the 1 Month Postvaccination 2 and 1 Year Postvaccination 2 blood draws.|
1697709|NCT01024738|3120145|Superiority or Other|||||||0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1697710|NCT01024608|3120154|Superiority or Other||LS mean treatment diff from placebo|-0.56||||0.002|2-Sided|95.0|-0.9|-0.2||A priori threshold for statistical significance is p<0.05|ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction|||
1697986|NCT01018732|3120810|Superiority or Other||ratio of titer|0.54|||||2-Sided|95.0|0.28|1.04||||||Day 8, Men W-135, Pairwise comparison of geometric mean titer|
1697728|NCT01024036|3120208|Superiority or Other||Difference of hemoglobin response rates|41.9||||0.0195|2-Sided|95.0|7.8|70.7|||Cochran-Mantel-Haenszel||Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care [BSC] arm minus hemoglobin response rate for Placebo+BSC arm.||
1697729|NCT01024036|3120209|Superiority or Other||Difference of hemoglobin response rates|61.3||||0.0002|2-Sided|95.0|28.3|85.1|||Cochran-Mantel-Haenszel||Difference in hemoglobin response rates is equal to hemoglobin response rate for siltuximab+best supportive care [BSC] arm minus hemoglobin response rate for Placebo+BSC arm.||
1697730|NCT01024036|3120210|Superiority or Other||Hazard Ratio (HR)|0.418||||0.0084|2-Sided|95.0|0.214|0.815|||Log Rank||Hazard ratio and 95% CI from a Cox proportional hazards model||
1697731|NCT01024036|3120212|Superiority or Other||Difference in overall response rates|33.9||||0.0022|2-Sided|95.0|11.1|54.8|||Cochran-Mantel-Haenszel||||
1697732|NCT01024036|3120214|Superiority or Other||difference in the response rate|34.0||||0.0004|2-Sided|95.0|11.1|54.8|||Fisher Exact|Without adjusting for the stratification factor: corticosteroid use||Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms|
1697733|NCT01024036|3120214|Superiority or Other||difference in the response rate|34.0||||0.0012|2-Sided|95.0|11.1|54.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factor: corticosteroid use||Null hypothesis: there is no difference in the durable tumor and symptomatic response rate between the 2 treatment arms|
1697734|NCT01023672|3120324|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||The analysis was done per protocol (n=17)|
1697735|NCT01023581|3120331|Superiority or Other||LS mean difference|-0.44|||<|0.001|2-Sided|95.0|-0.73|-0.16|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.|||
1697736|NCT01023581|3120331|Superiority or Other||LS mean difference|-1.0|||<|0.001|2-Sided|95.0|-1.29|-0.71|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.|||
1697737|NCT01023581|3120331|Superiority or Other||LS mean difference|-0.57|||<|0.001|2-Sided|95.0|-0.87|-0.27|||ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate|||
1697738|NCT01023581|3120331|Superiority or Other||LS mean difference|-0.67|||<|0.001|2-Sided|95.0|-0.96|-0.37||For each set of comparisons in the primary analysis, the null hypothesis was rejected only if both comparisons between a combination and its constituent doses were statistically significant at the 2-sided 2.5% level.|ANCOVA|ANCOVA model with treatment and geographic region as fixed effects and baseline HbA1c as a covariate.||The primary efficacy analysis consisted of 2 separate sets of comparisons between each BID combination of alogliptin and metformin (alogliptin/metformin 12.5/500 mg BID and 12.5/1000 mg BID) and its constituent doses of alogliptin and metformin. The null hypothesis was that the combination of alogliptin and metformin had no additional effect on glycemic control at Week 26 either when compared with the constituent dose of alogliptin or with the constituent dose of metformin.|
1697739|NCT01023568|3120332|Superiority or Other||||||>|0.99|||||||Chi-squared||||
1697740|NCT01023568|3120333|Superiority or Other|||||||0.26|||||||ANOVA||||
1697741|NCT01023568|3120334|Superiority or Other||Median Difference (Final Values)|0.0||||0.18|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)|1-tailed Wilcoxon sum-rank test|"The median difference was Hodges-Lehmann estimation and the confidence intervals were exact confidence limits. The SAS NPAR1WAY procedure was used for test and estimation."|The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.|
1697742|NCT01023568|3120334|Superiority or Other||Median Difference (Final Values)|1.0|||>|0.99|2-Sided|95.0|1.0|2.0|||Wilcoxon (Mann-Whitney)|1-tailed Wilcoxon sum-rank test|"The median difference was Hodges-Lehmann estimation and the confidence intervals were exact confidence limits. The SAS NPAR1WAY procedure was used for test and estimation."|The Cormack-Lehane grade with a grade 1 (best grade) to 4 (worst grade) was analyzed as an ordinal outcome.|
1697743|NCT01023568|3120335|Superiority or Other|||||||0.28|||||||ANOVA||||
1697744|NCT01023568|3120336|Non-Inferiority or Equivalence|The GlideScope and Truview PCD video laryngoscopes were individually assessed for non-inferiority on time to intubation vs direct laryngoscopy at the 0.025 significance level using an a priori specified non-inferiority delta of seven seconds (about 40% of the expected standard deviation of 18 sec and not thought to be clinically important).|Median Difference (Final Values)|17.0|||>|0.99|2-Sided|95.0|6.0|28.0|||Wilcoxon (Mann-Whitney)||Truview PCD - direct laryngoscopy||
1697745|NCT01023568|3120336|Non-Inferiority or Equivalence|The GlideScope and Truview PCD video laryngoscopes were individually assessed for non-inferiority on time to intubation vs direct laryngoscopy at the 0.025 significance level using an a priori specified non-inferiority delta of seven seconds (about 40% of the expected standard deviation of 18 sec and not thought to be clinically important).|Median Difference (Final Values)|14.0|||>|0.99|2-Sided|95.0|7.0|26.0|||Wilcoxon (Mann-Whitney)||Glidescope - direct laryngoscopy||
1697746|NCT01023256|3120390|Superiority or Other|||||||0.135||||||P values <0.05 were considered to be statistically significant.|Fisher Exact|Patients with missing values were not included.|||
1697747|NCT01023256|3120390|Superiority or Other||||||<|0.0001||||||P values < 0.05 were considered significant.|Fisher Exact|Patients with missing values were not included|||
1697748|NCT01023256|3120390|Superiority or Other||||||<|0.243||||||P values <0.05 were considered to be statistically significant.|Fisher Exact|Patients with missing values were not included|||
1697749|NCT01023256|3120391|Superiority or Other|||||||0.065||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values < 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.|||
1697750|NCT01023256|3120391|Superiority or Other|||||||0.003||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values < 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.|||
1697882|NCT01020474|3120637|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.655|2-Sided|95.0|-1.0|0.63|||ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).|||
1697751|NCT01023256|3120391|Superiority or Other|||||||0.421||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values < 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.|||
1697752|NCT01023256|3120393|Superiority or Other|||||||0.003||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values < 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.|||
1697753|NCT01023256|3120393|Superiority or Other||||||<|0.0001||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values < 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.|||
1697754|NCT01023256|3120393|Superiority or Other||||||<|0.095||||||P values were derived from pairwise comparisons between each MOR103 group and the pooled placebo group based on an analysis of covariance (ANCOVA) model. P values < 0.05 were considered significant.|ANCOVA|The ANCOVA model included fixed effect terms for dose and the covariate C-reactive protein level at baseline.|||
1697755|NCT01023061|3120406|Superiority||Median Difference (Final Values)|0.74|||<|0.01|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1697756|NCT01023035|3120408|Superiority or Other||Mean Difference (Final Values)|-0.7|||||2-Sided|95.0|-8.6|7.2||||||The modified Koch method was used to calculate the stratum-adjusted Mantel-Haenszel (MH) difference between the SVR rates for the Erythropoietin Use Arm versus the Ribavirin Dose Reduction Arm and corresponding 95% confidence interval with continuity correction.|
1697757|NCT01022762|3120448|Non-Inferiority or Equivalence|Non-inferiority would be shown if the upper limit of the 95% confidence interval was less than 0.4%. This corresponds to a one-sided test with a significance level of 2.5% of the hypothesis.|Mean Difference (Net)|0.014|Standard Error of the Mean|0.066||||95.0|-0.115|0.143|||||If non-inferiority of repaglinide alone was shown, a test for superiority would be performed based on FAS. Superiority of repaglinide alone over gliclazide alone would be claimed if the upper limit of the 95% CI for the difference was lower than 0%.|H0: Change from baseline in HbA1c of repaglinide therapy at 16 weeks of treatment - change from baseline in HbA1c of gliclazide therapy at 16 weeks of treatment >= 0.4%. H1: Change from baseline in HbA1c of repaglinide therapy at 16 weeks of treatment - change from baseline in HbA1c of gliclazide therapy at 16 weeks of treatment < 0.4%. Sample size was calculated to achieve a power of at least 85%, assuming an equal change in HbA1c and a common standard deviation of 1.2%.|
1697758|NCT01022307|3120461|Non-Inferiority or Equivalence|Power analysis showed that the effect size was small, with a 50% chance of detecting a p < 0.05 effect requiring 247 subjects.|||||<|0.04|||||||F-test|Greenhouse Geisser correction.||F-test evaluating effects of Group|
1697759|NCT01022242|3120462|Superiority or Other|||||||0.8861|||||||ANCOVA||||
1697760|NCT01022203|3120463|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|||General linear mixed models with main effects of treatment, time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions as described for previous analyses.|
1697761|NCT01022203|3120464|Superiority or Other||Slope|0.004|||<|0.001|2-Sided||||||Mixed Models Analysis|||Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes for veterans. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.|
1697762|NCT01022203|3120465|Superiority or Other||Slope|0.0001|||<|0.0001|2-Sided||||||Mixed Models Analysis|||Used Intent to Treat Analysis. General linear mixed models (GLMMs) with main effects of treatment (SAT and PFE), time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcomes, for veterans and their partners. Time was flexibly modeled. All available observations from each subject were utilized in the GLMM modeling.|
1697763|NCT01022073|3120470|Superiority or Other|||||||0.808|||||||t-test, 2 sided|This analysis is based on the completers. We are working on the imputation methods to account for the missing data and will revise results later.|||
1697764|NCT01021852|3120479|Superiority or Other||Mean Difference (Final Values)|-2.2|||||2-Sided|95.0|-4.5|2.3||||||Miettinen and Nurminen’s method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.|
1697765|NCT01021852|3120479|Superiority or Other||Mean Difference (Final Values)|0.3|||||2-Sided|95.0|-2.7|6.6||||||Miettinen and Nurminen’s method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.|
1697766|NCT01021852|3120479|Superiority or Other||Mean Difference (Final Values)|-0.9|||||2-Sided|95.0|-3.6|4.8||||||Miettinen and Nurminen’s method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.|
1697767|NCT01021852|3120479|Superiority or Other||Mean Difference (Final Values)|2.8|||||2-Sided|95.0|-1.0|10.2||||||Miettinen and Nurminen’s method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.|
1697768|NCT01021852|3120480|Superiority or Other||Mean Difference (Final Values)|8.5|||||2-Sided|95.0|-2.3|20.4||||||Miettinen and Nurminen’s method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.|
1697769|NCT01021852|3120480|Superiority or Other||Mean Difference (Final Values)|6.5|||||2-Sided|95.0|-4.2|18.3||||||Miettinen and Nurminen’s method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.|
1697770|NCT01021852|3120480|Superiority or Other||Mean Difference (Final Values)|-0.4|||||2-Sided|95.0|-10.3|11.2||||||Miettinen and Nurminen’s method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.|
1697771|NCT01021852|3120480|Superiority or Other||Mean Difference (Final Values)|0.6|||||2-Sided|95.0|-9.5|12.2||||||Miettinen and Nurminen’s method was used to calculate confidence intervals for between-treatment differences in the percentage of participants with events versus placebo.|
1697772|NCT01021852|3120481|Superiority or Other||Difference in LS Means|-11.3|Standard Error of the Mean|4.63||0.015|2-Sided|95.0|-20.5|-2.2|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697773|NCT01021852|3120481|Superiority or Other||Difference in LS Means|-19.5|Standard Error of the Mean|4.62|<|0.001|2-Sided|95.0|-28.6|-10.4|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697774|NCT01021852|3120481|Superiority or Other||Difference in LS Means|-8.7|Standard Error of the Mean|4.61|<|0.06|2-Sided|95.0|-17.8|0.4|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697775|NCT01021852|3120481|Superiority or Other||Difference in LS Means|-8.9|Standard Error of the Mean|4.61|<|0.055|2-Sided|95.0|-18.0|0.2|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697776|NCT01021852|3120481|Superiority or Other||Difference in LS Means|-20.3|Standard Error of the Mean|4.38|<|0.001|2-Sided|95.0|-29.0|-11.7|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697777|NCT01021852|3120481|Superiority or Other||Difference in LS Means|-23.5|Standard Error of the Mean|4.38|<|0.001|2-Sided|95.0|-32.1|-14.9|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697778|NCT01021852|3120481|Superiority or Other||Difference in LS Means|-15.7|Standard Error of the Mean|4.44|<|0.001|2-Sided|95.0|-24.5|-7.0|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697779|NCT01021852|3120481|Superiority or Other||Difference in LS Means|-10.2|Standard Error of the Mean|4.43|<|0.022|2-Sided|95.0|-18.9|-1.5|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697780|NCT01021852|3120482|Superiority or Other||Difference in LS Means|-30.0|Standard Error of the Mean|5.69|<|0.001|2-Sided|95.0|-41.2|-18.8|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697781|NCT01021852|3120482|Superiority or Other||Difference in LS Means|-25.7|Standard Error of the Mean|5.67|<|0.001|2-Sided|95.0|-36.8|-14.5|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697782|NCT01021852|3120482|Superiority or Other||Difference in LS Means|-13.2|Standard Error of the Mean|5.66|<|0.02|2-Sided|95.0|-24.4|-2.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697896|NCT01019694|3120709|Superiority or Other||Mean Difference (Final Values)|0.2||||0.3755||95.0|-0.24|0.65|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1698231|NCT01018134|3120924|Superiority or Other|||||||0.1583|||||||t-test, 1 sided||||
1697783|NCT01021852|3120482|Superiority or Other||Difference in LS Means|-15.5|Standard Error of the Mean|5.65|<|0.006|2-Sided|95.0|-26.7|-4.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697784|NCT01021852|3120482|Superiority or Other||Difference in LS Means|-45.8|Standard Error of the Mean|6.22|<|0.001|2-Sided|95.0|-58.0|-33.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697785|NCT01021852|3120482|Superiority or Other||Difference in LS Means|-30.9|Standard Error of the Mean|6.21|<|0.001|2-Sided|95.0|-43.2|-18.7|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697786|NCT01021852|3120482|Superiority or Other||Difference in LS Means|-32.5|Standard Error of the Mean|6.31|<|0.001|2-Sided|95.0|-44.9|-20.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697787|NCT01021852|3120482|Superiority or Other||Difference in LS Means|-30.8|Standard Error of the Mean|6.29|<|0.001|2-Sided|95.0|-43.2|-18.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697788|NCT01021852|3120483|Superiority or Other||Difference in LS Means|8.7|Standard Error of the Mean|1.43|<|0.001|2-Sided|95.0|5.9|11.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697789|NCT01021852|3120483|Superiority or Other||Difference in LS Means|9.7|Standard Error of the Mean|1.43|<|0.001|2-Sided|95.0|6.9|12.5|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697790|NCT01021852|3120483|Superiority or Other||Difference in LS Means|4.1|Standard Error of the Mean|1.42|<|0.004|2-Sided|95.0|1.3|6.9|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697791|NCT01021852|3120483|Superiority or Other||Difference in LS Means|4.6|Standard Error of the Mean|1.42|<|0.001|2-Sided|95.0|1.8|7.4|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Week 4~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Week 4. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697792|NCT01021852|3120483|Superiority or Other||Difference in LS Means|13.4|Standard Error of the Mean|1.57|<|0.001|2-Sided|95.0|10.3|16.5|||Mixed Models Analysis|||"MK-6096 20 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697793|NCT01021852|3120483|Superiority or Other||Difference in LS Means|10.7|Standard Error of the Mean|1.57|<|0.001|2-Sided|95.0|7.7|13.8|||Mixed Models Analysis|||"MK-6096 10 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697897|NCT01019694|3120709|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.7637||95.0|-0.5|0.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1698321|NCT01016977|3121121|Superiority or Other|||||||0.8545||||||Week 1|ANCOVA||||
1697794|NCT01021852|3120483|Superiority or Other||Difference in LS Means|9.9|Standard Error of the Mean|1.59|<|0.001|2-Sided|95.0|6.8|13.1|||Mixed Models Analysis|||"MK-6096 5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697795|NCT01021852|3120483|Superiority or Other||Difference in LS Means|8.4|Standard Error of the Mean|1.59|<|0.001|2-Sided|95.0|5.3|11.5|||Mixed Models Analysis|||"MK-6096 2.5 mg vs. Placebo at Night 1~A mixed effects model with terms for baseline value, geographic region (Japan vs. ex-Japan), gender, treatment, sequence, period, time, and treatment-by-time interaction and period-by-time interaction was used to estimate LS mean differences between MK-6096 and placebo at Night 1. 95% confidence interval estimate and p-value (based upon a normal approximation) were also computed from the LS mean differences and variability estimates from the model."|
1697796|NCT01021813|3120485|Superiority or Other||Difference in LS Means: Month 1|-9.5||||0.0002|2-Sided|95.0|-14.6|-4.5||To account for multiplicity, Hochberg’s procedure was used to control the overall Type I error rate at the 5% level.|Longitudinal Data Analysis|||A Longitudinal Data Analysis Model was used to test the difference in LS mean change from baseline in sTSOm for Month 1 (Average of Weeks 1, 2, 3, 4) in the Suvorexant group vs. the Placebo group.|
1697797|NCT01021813|3120486|Superiority or Other||Difference in LS Means: Month 1|22.7|||<|0.0001|2-Sided|95.0|16.4|29.0||To account for multiplicity, Hochberg’s procedure was used to control the overall Type I error rate at the 5% level.|Longitudinal Data Analysis|||A Longitudinal Data Analysis Model was used to test the difference in LS mean change from baseline in sTSTm for Month 1 (Average of Weeks 1, 2, 3, 4) in the Suvorexant group vs. the Placebo group.|
1697798|NCT01021813|3120487|Superiority or Other||Difference in Percentage:Night 1, 2 or 3|4.58||||0.409|2-Sided|95.0|-6.3|15.3|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Nights 1, 2, or 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.|
1697799|NCT01021813|3120487|Superiority or Other||Difference in Percentage: Night 3|4.96||||0.351|2-Sided|95.0|-5.5|15.3|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.|
1697800|NCT01021813|3120487|Superiority or Other||Difference in Percentage: Night 2|5.31||||0.311|2-Sided|95.0|-5.0|15.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.|
1697801|NCT01021813|3120487|Superiority or Other||Difference in Percentage: Night 1|4.46||||0.386|2-Sided|95.0|-5.7|14.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTSO rebound effects during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.|
1697802|NCT01021813|3120488|Superiority or Other||Difference in Percentage:Night 1, 2 or 3|10.82||||0.057|2-Sided|95.0|-0.3|21.7|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Nights 1, 2, or 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.|
1697803|NCT01021813|3120488|Superiority or Other||Difference in Percentage: Night 3|6.02||||0.287|2-Sided|95.0|-5.1|16.9|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.|
1697804|NCT01021813|3120488|Superiority or Other||Difference in Percentage: Night 2|8.72||||0.109|2-Sided|95.0|-2.0|19.2|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.|
1697805|NCT01021813|3120488|Superiority or Other||Difference in Percentage: Night 1|5.03||||0.365|2-Sided|95.0|-5.8|15.8|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with sTST rebound effects during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Placebo (DB Treatment)/Placebo (DB Discontinuation) group.|
1697806|NCT01021813|3120489|Superiority or Other||Difference in Percentage: Across Nights|0.0||||1|2-Sided|95.0|-6.4|6.4|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms across Nights 1, 2, and 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.|
1697883|NCT01020474|3120638|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.121|2-Sided|95.0|-1.51|0.18||Missing data for week 15 mean pain score are imputed based on distribution of baseline pain scores if participants discontinue due to adverse events/ abnormal laboratory test results or lack of efficacy.|ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).|||
1697807|NCT01021813|3120489|Superiority or Other||Difference in Percentage: Night 3|-0.78||||0.68|2-Sided|95.0|-5.6|3.9|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 3 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.|
1697808|NCT01021813|3120489|Superiority or Other||Difference in Percentage: Night 2|-2.4||||0.185|2-Sided|95.0|-7.3|1.6|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 2 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.|
1697809|NCT01021813|3120489|Superiority or Other||Difference in Percentage: Night 1|-0.81||||0.567|2-Sided|95.0|-5.1|3.1|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and compute the confidence interval for the point difference in a pairwise comparison of the percentage of participants with withdrawal symptoms during Night 1 in the Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation) group vs. the Suvorexant (DB Treatment)/Placebo (DB Discontinuation) group.|
1697810|NCT01021813|3120490|Superiority or Other||Difference in Percentage|-0.4||||0.767|2-Sided|95.0|-3.8|2.2|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any selected AEs associated with potential abuse between the Suvorexant group and Placebo group.|
1697811|NCT01021813|3120491|Superiority or Other||Difference in Percentage|0.8||||0.159|2-Sided|95.0|-0.7|2.0|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any Hypnagogic/hypnopompic hallucinations AEs between the Suvorexant group and Placebo group.|
1697812|NCT01021813|3120492|Superiority or Other||Difference in Percentage of AEs|0.8||||0.159|2-Sided|95.0|-0.7|2.0|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any suicidal ideation/behavior AEs considered an ECI between the Suvorexant group and Placebo group.|
1697813|NCT01021813|3120493|Superiority or Other||Difference in Percentage|-0.8||||0.508|2-Sided|95.0|-3.9|1.5|||Miettinen & Nurminen Method|||The method of Miettinen and Nurminen was used to calculate the p-value and construct the confidence interval for the difference in the percentage of participants with any falls AEs between the Suvorexant group and Placebo group.|
1697814|NCT01021813|3120494|Superiority or Other||Difference in Percentage|0.2||||0.482|2-Sided|95.0|-1.3|1.1|||Miettinen & Nurminen Method.|||The method of Miettinen and Nurminen was used to construct the confidence interval for the difference in the percentage of participants with any complex sleep-related behaviors AEs between the Suvorexant group and Placebo group.|
1697815|NCT01021813|3120495|Superiority or Other||Difference in Percentage|0.4|||||2-Sided|95.0|-1.1|1.4||||||The method of Miettinen and Nurminen was used to construct the confidence interval for the difference in the percentage of participants with any sleep paralysis AEs between the Suvorexant group and Placebo group .|
1697816|NCT01021553|3120521|Superiority or Other||Ratio of treatments|3.63|||||2-Sided|90.0|2.95|4.47|||||||
1697817|NCT01021553|3120522|Superiority or Other||Ratio of treatments|2.98|||||2-Sided|90.0|2.51|3.54|||||||
1697818|NCT01021553|3120522|Superiority or Other||Ratio of treatments|2.91|||||2-Sided|90.0|2.43|3.48|||||For AUC (0-inf)||
1697819|NCT01021553|3120525|Superiority or Other||Geometric LS Mean Fold Difference|1.03||||0.8971|2-Sided|95.0|0.64|1.67|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.||
1697820|NCT01021553|3120525|Superiority or Other||Geometric LS Mean Fold Difference|0.96||||0.879|2-Sided|95.0|0.56|1.65|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.||
1697821|NCT01021553|3120525|Superiority or Other||Geometric LS Mean Fold Difference|1.14||||0.6583|2-Sided|95.0|0.63|2.05|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.||
1697822|NCT01021553|3120526|Superiority or Other||Geometric LS Mean Fold Difference|1.18||||0.4347|2-Sided|95.0|0.77|1.8|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8|
1697823|NCT01021553|3120526|Superiority or Other||Geometric LS Mean Fold Difference|1.09||||0.7255|2-Sided|95.0|0.68|1.75|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8|
1697824|NCT01021553|3120526|Superiority or Other||Geometric LS Mean Fold Difference|1.33||||0.2798|2-Sided|95.0|0.79|2.24|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 4-8|
1697825|NCT01021553|3120526|Superiority or Other||Geometric LS Mean Fold Difference|1.01||||0.9541|2-Sided|95.0|0.71|1.43|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Weeks 0-4|
1697826|NCT01021553|3120526|Superiority or Other||Geometric LS Mean Fold Difference|1.0||||0.9939|2-Sided|95.0|0.67|1.48|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Week 0 to 4|
1697827|NCT01021553|3120526|Superiority or Other||Geometric LS Mean Fold Difference|1.03||||0.9037|2-Sided|95.0|0.67|1.58|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.|For Week 0 to 4|
1697828|NCT01021553|3120527|Superiority or Other||Geometric LS Mean Fold Difference|1.13||||0.4971|2-Sided|95.0|0.79|1.61|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.||
1697829|NCT01021553|3120527|Superiority or Other||Geometric LS Mean Fold Difference|1.11||||0.6161|2-Sided|95.0|0.74|1.65|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.||
1697830|NCT01021553|3120527|Superiority or Other||Geometric LS Mean Fold Difference|1.16||||0.4959|2-Sided|95.0|0.75|1.79|||ANCOVA||Estimated value is Geometric LS Mean Fold Difference from Placebo.||
1697884|NCT01020435|3120647|Other||Mean Difference (Final Values)|2.3|||||2-Sided|95.0|-1.2|5.8||||||Wk 6 - DBP (Adjusted)|
1697885|NCT01020435|3120647|Other||Mean Difference (Final Values)|4.8|||||2-Sided|95.0|-0.4|10.0||||||Wk 6 - SBP (Adjusted)|
1697886|NCT01020435|3120647|Other||Mean Difference (Final Values)|1.0|||||2-Sided|95.0|-2.8|4.9||||||Wk 3 - DBP (Adjusted)|
1697831|NCT01021293|3120574|Non-Inferiority|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 3 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference [Control Group minus Poliorix Group] in the percentage of seroprotected subjects|Difference in seroprotection rate|-1.69|||||2-Sided|95.0|-3.9|-0.44||||||Non-inferiority of Poliorix™ as compared to OPV|
1697832|NCT01021293|3120574|Non-Inferiority|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 2 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference [Control Group minus Poliorix Group] in the percentage of seroprotected subjects|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-1.28|1.24||||||Non-inferiority of Poliorix™ as compared to OPV|
1697833|NCT01021293|3120574|Non-Inferiority|Non-inferiority of Poliorix™ vaccine as compared to OPV vaccine in terms of the immune response to poliovirus type 1 one month after the third vaccine dose. Non-inferiority in terms of immunogenicity to poliovirus antigens was demonstrated if the upper limit of the 95% confidence interval (CI) on the group difference [Control Group minus Poliorix Group] in the percentage of seroprotected subjects|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-1.28|1.24||||||Non-inferiority of Poliorix™ as compared to OPV|
1697834|NCT01021111|3120586|Superiority or Other||||||<|0.05|||||||Pearson|||The association between the change in the thigh coronal angular velocity from baseline to follow-up and the change in the knee abduction moment from baseline to follow-up was assessed with the Pearson correlation coefficient (R), alpha =0.05|
1697835|NCT01021111|3120587|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|||The values from the three jumps were averaged in order to have one mean value per subject per session. Paired Student t-tests (baseline vs. follow-up) were used to evaluate the effects of the training.|
1697836|NCT01021007|3120591|Superiority or Other|||||||0.05|||||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.|
1697837|NCT01021007|3120592|Superiority or Other|||||||0.05|||||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.|
1697838|NCT01021007|3120593|Superiority or Other|||||||0.005|||||||ANCOVA|ANCOVA method using treatment as the factor and the baseline score as a covariate||The null hypothesis states that there is no difference between groups.|
1697839|NCT01020877|3120598|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.0|||||2-Sided|90.0|97.6|115.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1697840|NCT01020877|3120599|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|106.0|||||2-Sided|90.0|98.2|115.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1697841|NCT01020877|3120600|Non-Inferiority or Equivalence|ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test[T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).|Ratio of the T/R geometric mean x 100|110.0|||||2-Sided|90.0|103.0|117.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1697842|NCT01020838|3120606|Superiority or Other||Specificity|0.942|||||2-Sided|95.0|0.886|0.998|||||Point estimate of specificity was calculated using the method of Rao and Scott. Variance for specificity is based on subjects that contribute at least one brain region, which is amyloid negative according to the SoT|"For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for specificity in amyloid detection based on the majority read.~The following hypothesis was formulated for specificity:~H0,spec: specificity ≤ 0.8 vs. H1, spec: specificity > 0.8 H0,spec was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.8"|
1697843|NCT01020838|3120606|Superiority or Other||Sensitivity|0.774|||||2-Sided|95.0|0.654|0.894|||||Point estimate of sensitivity was calculated by the method of Rao and Scott. Variance for sensitivity is based on subjects that contribute at least one brain region, which is amyloid positive according to the SoT|"For the primary analysis, point estimates together with normal-approximated, two sided 95% confidence intervals, were given for sensitivity in beta-amyloid detection based on the majority read.~The following hypothesis was formulated for sensitivity:~H0,sens: sensitivity ≤ 0.6 vs. H1, sens: sensitivity > 0.6 H0,sens was to be rejected if the lower bound of the two-sided 95% CI is larger than 0.6"|
1697844|NCT01020812|3120609|Superiority or Other||probability|0.4|||||2-Sided||||||||This is the overall survival probability at 18 months.|The data was analyzed using the Kaplan Meier estimator.|
1697845|NCT01020812|3120610|Superiority or Other||proportion of participants|0.286|||||2-Sided|95.0|0.031|0.636|||||The data was analyzed in a competing risk model with death as a competing risk. The proportion of 0.286 is the cumulative incidence function at 12 months.|The data was analyzed in a competitive risk model with the cumulative incidence function as the estimator. Death and other progression were competitive risks.|
1697846|NCT01020773|3120626|Superiority or Other||||||>|0.05|||||||ANOVA||||
1697887|NCT01020435|3120647|Other||Mean Difference (Final Values)|0.9|||||2-Sided|95.0|-5.0|6.9||||||Wk 3 - SBP (Adjusted)|
1697888|NCT01020435|3120647|Other||Mean Difference (Final Values)|3.6|||||2-Sided|95.0|0.6|6.5||||||Tx 1 - DBP (Adjusted)|
1697847|NCT01020591|3120629|Non-Inferiority or Equivalence|The power and sample size calculations, based on the ability to detect treatment and evaluation group differences, were performed on Minitab™ V.15. 40 participants were estimated to be required for group allocation (20 in each group: evaluation;evaluation and treatment)for 80% power in at least 3 out of the 4 outcome measures. After 30 subjects, analysis determined that there would be no further statistically significant changes in results therefore, data collection was stopped at 30 subjects.|||||<|0.05|||||||ANOVA|||A two factor mixed model Analysis of Variance (ANOVA) for Group (Evaluation vs. Treatment) with repeated measures (pre vs. post test) was employed to test for main effects and all interactions for the Resistive Index|
1697848|NCT01020474|3120631|Superiority or Other|||||||0.013|||||||Cochran-Mantel-Haenszel|P-value uses the row mean score statistic based on Cochran Mantel Haenszel (CMH) test with modified ridit transformation.||Statistical analysis at Week 15.|
1697849|NCT01020474|3120632|Superiority or Other||Odds Ratio (OR)|2.25||||0.162|2-Sided|95.0|0.72|7.02|||Regression, Logistic|||Statistical analysis at Week 15.|
1697850|NCT01020474|3120633|Superiority or Other||Odds Ratio (OR)|1.17||||0.694|2-Sided|95.0|0.53|2.58|||Regression, Logistic|||Statistical analysis at Week 15.|
1697851|NCT01020474|3120634|Superiority or Other||Mean Difference (Final Values)|-0.87||||0.037|2-Sided|95.0|-1.68|-0.05|||ANCOVA|Based on LS Means using analysis of covariance (ANCOVA) model (including Treatment, Center, Baseline value as covariate).|||
1697852|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.663|2-Sided|95.0|-0.95|0.61|||Mixed Models Analysis|||Statistical analysis of Week 15.|
1697853|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-0.41||||0.285|2-Sided|95.0|-1.18|0.35|||Mixed Models Analysis|||Statistical analysis of Week 14.|
1697854|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.376|2-Sided|95.0|-1.09|0.41|||Mixed Models Analysis|||Statistical analysis of Week 13.|
1697855|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-0.61||||0.105|2-Sided|95.0|-1.36|0.13|||Mixed Models Analysis|||Statistical analysis of Week 12.|
1697856|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-0.43||||0.246|2-Sided|95.0|-1.16|0.3|||Mixed Models Analysis|||Statistical analysis of Week 11.|
1697857|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-0.77||||0.037|2-Sided|95.0|-1.49|-0.05|||Mixed Models Analysis|||Statistical analysis of Week 10.|
1697858|NCT01020474|3120635|Superiority or Other||Median Difference (Final Values)|-0.57||||0.12|2-Sided|95.0|-1.29|0.15|||Mixed Models Analysis|||Statistical analysis of Week 9.|
1697859|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-1.01||||0.006|2-Sided|95.0|-1.73|-0.3|||Mixed Models Analysis|||Statistical analysis of Week 8.|
1697860|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.168|2-Sided|95.0|-1.21|0.21|||Mixed Models Analysis|||Statistical analysis of Week 7.|
1697861|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-0.64||||0.075|2-Sided|95.0|-1.34|0.06|||Mixed Models Analysis|||Statistical analysis of Week 6.|
1697862|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-0.38||||0.28|2-Sided|95.0|-1.08|0.32|||Mixed Models Analysis|||Statistical analysis of Week 5.|
1697863|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-0.49||||0.168|2-Sided|95.0|-1.18|0.21|||Mixed Models Analysis|||Statistical analysis of Week 4.|
1697864|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-0.44||||0.206|2-Sided|95.0|-1.13|0.25|||Mixed Models Analysis|||Statistical analysis of Week 3.|
1697865|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.593|2-Sided|95.0|-0.87|0.5|||Mixed Models Analysis|||Statistical analysis of Week 2|
1697866|NCT01020474|3120635|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.54|2-Sided|95.0|-0.9|0.47|||Mixed Models Analysis|||Statistical analysis of Week 1.|
1697867|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-0.74||||0.06|2-Sided|95.0|-1.51|0.03|||Mixed Models Analysis|||Statistical analysis of Week 15.|
1697868|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.02|2-Sided|95.0|-1.66|-0.14|||Mixed Models Analysis|||Statistical analysis of Week 14.|
1697869|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-0.74||||0.051|2-Sided|95.0|-1.49|0.0|||Mixed Models Analysis|||Statistical analysis of Week 13.|
1697870|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-0.97||||0.01|2-Sided|95.0|-1.71|-0.23|||Mixed Models Analysis|||Statistical analysis of Week 12.|
1697871|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-0.86||||0.021|2-Sided|95.0|-1.59|-0.13|||Mixed Models Analysis|||Statistical analysis of Week 11.|
1697872|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-0.97||||0.008|2-Sided|95.0|-1.69|-0.25|||Mixed Models Analysis|||Statistical analysis of Week 10.|
1697873|NCT01020474|3120636|Superiority or Other||Median Difference (Final Values)|-0.95||||0.009|2-Sided|95.0|-1.67|-0.24|||Mixed Models Analysis|||Statistical analysis of Week 9.|
1697874|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-1.06||||0.004|2-Sided|95.0|-1.77|-0.35|||Mixed Models Analysis|||Statistical analysis of Week 8.|
1697875|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-0.89||||0.013|2-Sided|95.0|-1.6|-0.19|||Mixed Models Analysis|||Statistical analysis of Week 7.|
1697876|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-0.96||||0.008|2-Sided|95.0|-1.66|-0.26|||Mixed Models Analysis|||Statistical analysis of Week 6.|
1697877|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-0.68||||0.056|2-Sided|95.0|-1.38|0.02|||Mixed Models Analysis|||Statistical analysis of Week 5.|
1697878|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.011|2-Sided|95.0|-1.59|-0.21|||Mixed Models Analysis|||Statistical analysis of Week 4.|
1697879|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-0.83||||0.019|2-Sided|95.0|-1.51|-0.14|||Mixed Models Analysis|||Statistical analysis of Week 3.|
1697880|NCT01020474|3120636|Superiority or Other||Mean Difference (Final Values)|-0.63||||0.07|2-Sided|95.0|-1.32|0.05|||Mixed Models Analysis|||Statistical analysis of Week 2|
1697889|NCT01020435|3120647|Other||Mean Difference (Final Values)|4.7|||||2-Sided|95.0|-0.4|9.8||||||Tx 1 - SBP (Adjusted)|
1697898|NCT01019694|3120710|Superiority or Other||Mean Difference (Final Values)|0.2||||0.4886||95.0|-0.28|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697899|NCT01019694|3120710|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.4339||95.0|-0.6|0.26|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697900|NCT01019694|3120711|Superiority or Other||Mean Difference (Final Values)|0.5||||0.0163||95.0|0.1|0.95|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697901|NCT01019694|3120711|Superiority or Other||Mean Difference (Final Values)|0.1||||0.5645||95.0|-0.3|0.54|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697902|NCT01019694|3120712|Superiority or Other||Mean Difference (Final Values)|0.2||||0.2362||95.0|-0.15|0.62|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697903|NCT01019694|3120712|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9506||95.0|-0.4|0.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697904|NCT01019694|3120713|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.6976||95.0|-0.35|0.23|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697905|NCT01019694|3120713|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.476||95.0|-0.4|0.19|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697906|NCT01019694|3120715|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.6659||95.0|-0.112|0.071|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697907|NCT01019694|3120715|Superiority or Other||Mean Difference (Final Values)|0.05||||0.2596||95.0|-0.038|0.141|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697908|NCT01019694|3120716|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.6455||95.0|-0.106|0.066|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697909|NCT01019694|3120716|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.6396||95.0|-0.104|0.064|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697910|NCT01019694|3120717|Superiority or Other||Mean Difference (Final Values)|0.02||||0.5424||95.0|-0.052|0.099|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697911|NCT01019694|3120717|Superiority or Other||Mean Difference (Final Values)|0.06||||0.0893||95.0|-0.01|0.139|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697912|NCT01019694|3120718|Superiority or Other||Mean Difference (Final Values)|0.02||||0.659||95.0|-0.057|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697913|NCT01019694|3120718|Superiority or Other||Mean Difference (Final Values)|0.03||||0.402||95.0|-0.042|0.105|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697914|NCT01019694|3120719|Superiority or Other||Mean Difference (Final Values)|0.0||||0.8896||95.0|-0.058|0.05|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697915|NCT01019694|3120719|Superiority or Other||Mean Difference (Final Values)|0.06||||0.0328||95.0|0.005|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction|||
1697916|NCT01019694|3120720|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.7242||95.0|-0.054|0.038|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697917|NCT01019694|3120720|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.5852||95.0|-0.058|0.033|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697918|NCT01019694|3120721|Superiority or Other||Mean Difference (Final Values)|0.03||||0.2651||95.0|-0.02|0.072|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697919|NCT01019694|3120721|Superiority or Other||Mean Difference (Final Values)|0.04||||0.1185||95.0|-0.009|0.081|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697920|NCT01019694|3120722|Superiority or Other||Mean Difference (Final Values)|0.01||||0.6587||95.0|-0.032|0.05|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697921|NCT01019694|3120722|Superiority or Other||Mean Difference (Final Values)|0.0||||0.8282||95.0|-0.036|0.045|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697922|NCT01019694|3120723|Superiority or Other||Mean Difference (Final Values)|0.1||||0.3824||95.0|-0.15|0.38|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697923|NCT01019694|3120723|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.463||95.0|-0.36|0.16|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697924|NCT01019694|3120724|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.1404||95.0|-0.44|0.06|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1698322|NCT01016977|3121122|Superiority or Other|||||||0.654||||||Week 12|ANCOVA||||
1697925|NCT01019694|3120724|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.299||95.0|-0.38|0.12|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697926|NCT01019694|3120725|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.3949||95.0|-0.33|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697927|NCT01019694|3120725|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.4197||95.0|-0.32|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697928|NCT01019694|3120726|Superiority or Other||Mean Difference (Final Values)|0.0||||0.6978||95.0|-0.17|0.26|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697929|NCT01019694|3120726|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.1884||95.0|-0.36|0.07|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697930|NCT01019694|3120727|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.3342||95.0|-0.28|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697931|NCT01019694|3120727|Superiority or Other||Mean Difference (Final Values)|0.0||||0.6236||95.0|-0.23|0.14|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697932|NCT01019694|3120729|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.2691||95.0|-0.39|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697933|NCT01019694|3120729|Superiority or Other||Mean Difference (Final Values)|0.1||||0.5142||95.0|-0.16|0.33|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697934|NCT01019694|3120730|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.6144||95.0|-0.31|0.18|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697935|NCT01019694|3120730|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.2499||95.0|-0.38|0.1|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697936|NCT01019694|3120731|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.3171||95.0|-0.34|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697937|NCT01019694|3120731|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.524||95.0|-0.29|0.15|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697938|NCT01019694|3120732|Superiority or Other||Mean Difference (Final Values)|0.0||||0.7433||95.0|-0.18|0.25|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697939|NCT01019694|3120732|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.3578||95.0|-0.31|0.11|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697940|NCT01019694|3120733|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.3093||95.0|-0.28|0.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697941|NCT01019694|3120733|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.5695||95.0|-0.24|0.13|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697942|NCT01019694|3120735|Superiority or Other||Mean Difference (Final Values)|0.3||||0.0245||95.0|0.04|0.54|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697943|NCT01019694|3120735|Superiority or Other||Mean Difference (Final Values)|0.2||||0.0673||95.0|-0.02|0.47|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697944|NCT01019694|3120736|Superiority or Other||Mean Difference (Final Values)|0.4||||0.0004||95.0|0.2|0.68|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697945|NCT01019694|3120736|Superiority or Other||Mean Difference (Final Values)|0.4||||0.0006||95.0|0.18|0.65|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697946|NCT01019694|3120737|Superiority or Other||Mean Difference (Final Values)|0.5|||<|0.0001||95.0|0.25|0.71|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697947|NCT01019694|3120737|Superiority or Other||Mean Difference (Final Values)|0.4|||<|0.0023||95.0|0.13|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697948|NCT01019694|3120738|Superiority or Other||Mean Difference (Final Values)|0.4||||0.0013||95.0|0.16|0.66|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697949|NCT01019694|3120738|Superiority or Other||Mean Difference (Final Values)|0.1||||0.2826||95.0|-0.11|0.38|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697950|NCT01019694|3120739|Superiority or Other||Mean Difference (Final Values)|0.4||||0.0026||95.0|0.13|0.59|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697951|NCT01019694|3120739|Superiority or Other||Mean Difference (Final Values)|0.2||||0.1167||95.0|-0.05|0.42|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697952|NCT01019694|3120741|Superiority or Other||Mean Difference (Final Values)|7.7|||<|0.0001||95.0|4.23|11.23|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697953|NCT01019694|3120741|Superiority or Other||Mean Difference (Final Values)|11.3|||<|0.0001||95.0|7.9|14.76|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697954|NCT01019694|3120742|Superiority or Other||Mean Difference (Final Values)|7.7|||<|0.0001||95.0|4.44|10.96|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697955|NCT01019694|3120742|Superiority or Other||Mean Difference (Final Values)|9.2|||<|0.0001||95.0|5.94|12.37|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697956|NCT01019694|3120743|Superiority or Other||Mean Difference (Final Values)|9.6|||<|0.0001||95.0|6.44|12.83|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697957|NCT01019694|3120743|Superiority or Other||Mean Difference (Final Values)|7.9|||<|0.0001||95.0|4.71|11.09|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697958|NCT01019694|3120744|Superiority or Other||Mean Difference (Final Values)|7.4|||<|0.0001||95.0|4.41|10.39|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697959|NCT01019694|3120744|Superiority or Other||Mean Difference (Final Values)|5.3|||<|0.0006||95.0|2.29|8.28|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697960|NCT01019694|3120745|Superiority or Other||Mean Difference (Final Values)|6.2||||0.0009||95.0|2.57|9.91|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Atrovent + Albuterol Aerosols|
1697961|NCT01019694|3120745|Superiority or Other||Mean Difference (Final Values)|9.6|||<|0.0001||95.0|6.02|13.19|||Mixed Models Analysis|Adjusted for baseline and baseline-by-test-day interaction||Comparison of Combivent Respimat versus Combivent Inhalation Aerosol|
1697962|NCT01019486|3120746|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Comparison between groups using a two-tailed Student t test|
1697963|NCT01019486|3120747|Non-Inferiority or Equivalence|If sufficient subjects were enrolled then it would be expected that the MRI measurement of myocardial blood flow MBF would similar or equivalent to the invasively measured CFR in response to intravenous regadenoson administration.|None insufficient data|2.0||||0.05|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)|||No analysis was performed due to limited data.|
1697964|NCT01019486|3120748|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Independent Student t test between groups with two-tailed analysis|
1697965|NCT01019486|3120748|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Independent Student t test between arms with two tailed analysis.|
1697966|NCT01019486|3120748|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Independent Student t test between arms with two tailed analysis|
1697967|NCT01019252|3120756|Superiority||Mean Difference (Net)|10.93|||<|0.0001|2-Sided|95.0|8.93|12.93|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.|||
1697968|NCT01019252|3120757|Superiority or Other||Mean Difference (Final Values)|1.17|||<|0.0001|2-Sided|95.0|0.94|1.39|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.|||
1697969|NCT01019252|3120758|Superiority or Other||Mean Difference (Final Values)|5.24|||<|0.0001|2-Sided|95.0|3.28|7.21|||Mixed Models Analysis|A longitudinal general linear mixed effects model was used.|||
1697970|NCT01018979|3120779|Superiority or Other|||||||0.038||||||P values less than 0.05 are considered statistically significant in this study.|t-test, 2 sided|||Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.|
1697971|NCT01018979|3120779|Superiority or Other|||||||0.023||||||P values less than 0.05 are considered statistically significant in this study.|t-test, 2 sided|||Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.|
1697972|NCT01018732|3120810|Superiority or Other||ratio of titer|19.0|||||2-Sided|95.0|10.0|35.0||||||Day 29, Men Y, Pairwise comparison of geometric mean titer|
1697973|NCT01018732|3120810|Superiority or Other||ratio of titer|33.0|||||2-Sided|95.0|18.0|60.0||||||Day 29, Men Y, Pairwise comparison of geometric mean titer|
1697974|NCT01018732|3120810|Superiority or Other||ratio of titer|0.58|||||2-Sided|95.0|0.32|1.05||||||Day 29, Men Y, Pairwise comparison of geometric mean titer|
1697975|NCT01018732|3120810|Superiority or Other||ratio of titer|40.0|||||2-Sided|95.0|20.0|80.0||||||Day 8, Men Y, Pairwise comparison of geometric mean titer|
1697976|NCT01018732|3120810|Superiority or Other||ratio of titer|121.0|||||2-Sided|95.0|61.0|241.0||||||Day 8, Men Y, Pairwise comparison of geometric mean titer|
1697977|NCT01018732|3120810|Superiority or Other||ratio of titer|0.33|||||2-Sided|95.0|0.16|0.66||||||Day 8, Men Y, Pairwise comparison of geometric mean titer|
1697978|NCT01018732|3120810|Superiority or Other||ratio of titer|3.24|||||2-Sided|95.0|1.71|6.13||||||Day 1, Men Y, Pairwise comparison of geometric mean titer|
1697979|NCT01018732|3120810|Superiority or Other||ratio of titer|3.61|||||2-Sided|95.0|1.94|6.74||||||Day 1, Men Y, Pairwise comparison of geometric mean titer|
1697980|NCT01018732|3120810|Superiority or Other||ratio of titer|0.9|||||2-Sided|95.0|0.48|1.69||||||Day 1, Men Y, Pairwise comparison of geometric mean titer|
1697981|NCT01018732|3120810|Superiority or Other||ratio of titer|21.0|||||2-Sided|95.0|12.0|36.0||||||Day 29, Men W-135, Pairwise comparison of geometric mean titer|
1697982|NCT01018732|3120810|Superiority or Other||ratio of titer|35.0|||||2-Sided|95.0|20.0|60.0||||||Day 29, Men W-135, Pairwise comparison of geometric mean titer|
1697983|NCT01018732|3120810|Superiority or Other||ratio of titer|0.6|||||2-Sided|95.0|0.34|1.04||||||Day 29, Men W-135, Pairwise comparison of geometric mean titer|
1697984|NCT01018732|3120810|Superiority or Other||ratio of titer|27.0|||||2-Sided|95.0|14.0|52.0||||||Day 8, Men W-135, Pairwise comparison of geometric mean titer|
1697987|NCT01018732|3120810|Superiority or Other||ratio of titer|2.77|||||2-Sided|95.0|1.38|5.57||||||Day 1, Men W-135, Pairwise comparison of geometric mean titer|
1697988|NCT01018732|3120810|Superiority or Other||ratio of titer|2.51|||||2-Sided|95.0|1.27|4.96||||||Day 1, Men W-135, Pairwise comparison of geometric mean titer|
1697989|NCT01018732|3120810|Superiority or Other||ratio of titer|1.11|||||2-Sided|95.0|0.55|2.21||||||Day 1, Men W-135, Pairwise comparison of geometric mean titer|
1697990|NCT01018732|3120810|Superiority or Other||ratio of titer|9.61|||||2-Sided|95.0|4.69|20.0||||||Day 29, Men C, Pairwise comparison of geometric mean titer|
1697991|NCT01018732|3120810|Superiority or Other||ratio of titer|24.0|||||2-Sided|95.0|12.0|48.0||||||Day 29, Men C, Pairwise comparison of geometric mean titer|
1697992|NCT01018732|3120810|Superiority or Other||ratio of titer|0.4|||||2-Sided|95.0|0.2|0.82||||||Day 29, Men C, Pairwise comparison of geometric mean titer|
1697993|NCT01018732|3120810|Superiority or Other||ratio of titer|23.0|||||2-Sided|95.0|10.0|51.0||||||Day 8, Men C, Pairwise comparison of geometric mean titer|
1697994|NCT01018732|3120810|Superiority or Other||ratio of titer|45.0|||||2-Sided|95.0|21.0|97.0||||||Day 8, Men C, Pairwise comparison of geometric mean titer|
1697995|NCT01018732|3120810|Superiority or Other||ratio of titer|0.52|||||2-Sided|95.0|0.23|1.13||||||Day 8, Men C, Pairwise comparison of geometric mean titer|
1697996|NCT01018732|3120810|Superiority or Other||ratio of titer|2.78|||||2-Sided|95.0|1.47|5.27||||||Day 1, Men C, Pairwise comparison of geometric mean titer|
1697997|NCT01018732|3120810|Superiority or Other||ratio of titer|1.05|||||2-Sided|95.0|0.56|1.97||||||Day 1, Men C, Pairwise comparison of geometric mean titer|
1697998|NCT01018732|3120810|Superiority or Other||ratio of titer|2.64|||||2-Sided|95.0|1.4|4.99||||||Day 1, Men C, Pairwise comparison of geometric mean titer|
1697999|NCT01018732|3120810|Superiority or Other||ratio of titer|7.22|||||2-Sided|95.0|3.86|13.0||||||Day 29, Men A, Pairwise comparison of geometric mean titer|
1698000|NCT01018732|3120810|Superiority or Other||ratio of titer|5.56|||||2-Sided|95.0|3.01|10.0||||||Day 29, Men A, Pairwise comparison of geometric mean titer|
1698001|NCT01018732|3120810|Superiority or Other||ratio of titer|1.3|||||2-Sided|95.0|0.7|2.42||||||Day 29, Men A, Pairwise comparison of geometric mean titer|
1698002|NCT01018732|3120810|Superiority or Other||ratio of titer|31.0|||||2-Sided|95.0|14.0|69.0||||||Day 8, Men A, Pairwise comparison of geometric mean titer|
1698003|NCT01018732|3120810|Superiority or Other||ratio of titer|24.0|||||2-Sided|95.0|11.0|52.0||||||Day 8, Men A, Pairwise comparison of geometric mean titer|
1698004|NCT01018732|3120810|Superiority or Other||ratio of titer|1.31|||||2-Sided|95.0|0.59|2.91||||||Day 8, Men A, Pairwise comparison of geometric mean titer|
1698005|NCT01018732|3120810|Superiority or Other||ratio of titer|1.68|||||2-Sided|95.0|0.98|2.9||||||Day 1, Men A, Pairwise comparison of geometric mean titer|
1698006|NCT01018732|3120810|Superiority or Other||ratio of titer|0.71|||||2-Sided|95.0|0.42|1.2||||||Day 1, Men A, Pairwise comparison of geometric mean titer|
1698007|NCT01018732|3120810|Superiority or Other||ratio of titer|2.39|||||2-Sided|95.0|1.39|4.1||||||Day 1, Men A, Pairwise comparison of geometric mean titer|
1698008|NCT01018680|3120812|Superiority or Other|||||||0.413||||||This is the p-value for psychiatric visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared||||
1698009|NCT01018680|3120812|Superiority or Other|||||||0.89||||||This is the p-value for the average number of hours of volunteer work per week. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared||||
1698010|NCT01018680|3120812|Superiority or Other|||||||0.666||||||This is the p-value for how long the participant has had this job. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared||||
1698011|NCT01018680|3120812|Superiority or Other|||||||0.183||||||This is the p-value for the average number of hours worked for pay per week. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared||||
1698012|NCT01018680|3120812|Superiority or Other|||||||0.332||||||This is the p-value for outpatient visits to other physicians. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared||||
1698013|NCT01018680|3120812|Superiority or Other|||||||0.414||||||This is the p-value for emergency room visits for non-psychiatric illness. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared||||
1698014|NCT01018680|3120812|Superiority or Other|||||||0.087||||||This is the p-value for outpatient individual visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared||||
1698015|NCT01018680|3120812|Superiority or Other|||||||0.241||||||This is the p-value for outpatient group visits. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Likelihood Ratio Chi-squared||||
1698016|NCT01018680|3120813|Superiority or Other|||||||0.249||||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact||||
1698017|NCT01018680|3120814|Superiority or Other|||||||0.018||||||This is the p-value for Systolic Hypertension. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact||||
1698018|NCT01018680|3120814|Superiority or Other|||||||0.063||||||This is the p-value for Diastolic Hypertension. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact||||
1698019|NCT01018680|3120815|Superiority or Other|||||||0.031||||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact||||
1698020|NCT01018680|3120816|Superiority or Other|||||||0.106||||||This is the p-value for PCS Weight Loss. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact||||
1698021|NCT01018680|3120816|Superiority or Other|||||||0.724||||||This is the p-value for PCS Weight Gain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact||||
1698022|NCT01018680|3120817|Superiority or Other|||||||0.012||||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact||||
1698023|NCT01018680|3120818|Superiority or Other||||||<|0.001||||||This is the p-value for the 50% Response (LOCF) based on BPI Average Pain Ratings.|Fisher Exact||||
1698024|NCT01018680|3120818|Superiority or Other||||||<|0.001||||||This is the p-value for the 30% Response (LOCF) based on BPI Average Pain Ratings.|Fisher Exact||||
1698025|NCT01018680|3120819|Superiority or Other||||||<|0.001||||||This is the p-value for the 50% Response (LOCF) based on 24-Hour Average Pain Ratings. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact||||
1698026|NCT01018680|3120819|Superiority or Other||||||<|0.001||||||This is the p-value for the 30% Response (LOCF) based on 24-Hour Average Pain Ratings. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact||||
1698027|NCT01018680|3120820|Superiority or Other||||||<|0.001||||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Fisher Exact||||
1698028|NCT01018680|3120821|Superiority or Other||Mean Difference (Final Values)|-4.0||||0.083||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698029|NCT01018680|3120822|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.883||95.0||||This is the p-value for the BPOMS Confusion-Bewilderment Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698030|NCT01018680|3120822|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.862||95.0||||This is the p-value for the BPOMS Fatigue-Inertia Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698031|NCT01018680|3120822|Superiority or Other||Mean Difference (Final Values)|0.37||||0.356||95.0||||This is the p-value for the BPOMS Vigor-Activity Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698032|NCT01018680|3120822|Superiority or Other||Mean Difference (Final Values)|-0.52||||0.041||95.0||||This is the p-value for the BPOMS Anger-Hostility Score. 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698033|NCT01018680|3120822|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.18||95.0||||This is the p-value for the BPOMS Depression-Dejection Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698034|NCT01018680|3120822|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.265||95.0||||This is the p-value for the BPOMS Tension-Anxiety Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698035|NCT01018680|3120822|Superiority or Other||Mean Difference (Final Values)|-0.83||||0.449||95.0||||This is the p-value for the BPOMS Total Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698036|NCT01018680|3120823|Superiority or Other||Mean Difference (Final Values)|-1.17|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698037|NCT01018680|3120824|Superiority or Other||Mean Difference (Final Values)|-0.35|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698038|NCT01018680|3120825|Superiority or Other||Mean Difference (Final Values)|-0.84|||<|0.001||95.0||||This is the p-value for BPI-I for Mean Interference Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698039|NCT01018680|3120825|Superiority or Other||Mean Difference (Final Values)|-0.77|||<|0.001||95.0||||This is the p-value for BPI-I for Enjoyment of Life. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698040|NCT01018680|3120825|Superiority or Other||Mean Difference (Final Values)|-0.68|||<|0.001||95.0||||This is the p-value for BPI-I for Sleep. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698041|NCT01018680|3120825|Superiority or Other||Mean Difference (Final Values)|-0.69|||<|0.001||95.0||||This is the p-value for BPI-I for Relations with Others. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698042|NCT01018680|3120825|Superiority or Other||Mean Difference (Final Values)|-0.85|||<|0.001||95.0||||This is the p-value for BPI-I for Normal Work. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698043|NCT01018680|3120825|Superiority or Other||Mean Difference (Final Values)|-0.95|||<|0.001||95.0||||This is the p-value for BPI-I for Walking Ability. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698044|NCT01018680|3120825|Superiority or Other||Mean Difference (Final Values)|-0.72|||<|0.001||95.0||||This is the p-value for BPI-I for Mood. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698045|NCT01018680|3120825|Superiority or Other||Mean Difference (Final Values)|-0.97|||<|0.001||95.0||||This is the p-value for BPI-I for General Activity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698046|NCT01018680|3120825|Superiority or Other||Mean Difference (Final Values)|-0.71|||<|0.001||95.0||||This is the p-value for BPI-S for Pain Right Now. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698047|NCT01018680|3120825|Superiority or Other||Mean Difference (Final Values)|-0.95|||<|0.001||95.0||||This is the p-value for BPI-S for Average Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698048|NCT01018680|3120825|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.001||95.0||||This is the p-value for BPI-S for Least Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698049|NCT01018680|3120825|Superiority or Other||Mean Difference (Final Values)|-1.08|||<|0.001||95.0||||This is the p-value for BPI-S for Worst Pain. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698050|NCT01018680|3120826|Superiority or Other||Mean Difference (Final Values)|-1.03|||<|0.001||95.0||||This is the p-value for Worst Pain Intensity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698051|NCT01018680|3120826|Superiority or Other||Mean Difference (Final Values)|-0.8|||<|0.001||95.0||||This is the p-value for Night Pain Intensity. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698052|NCT01018680|3120827|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.004||95.0||||This is the p-value for WOMAC Stiffness Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698053|NCT01018680|3120827|Superiority or Other||Mean Difference (Final Values)|-1.28|||<|0.001||95.0||||This is the p-value for the WOMAC Pain Score. A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698054|NCT01018680|3120827|Superiority or Other||Mean Difference (Final Values)|-4.84|||<|0.001||95.0||||WOMAC Physical Disability Score p-value. Second gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 2 secondary outcomes with sequential treatment comparisons until outcome failed significance (p>0.05).|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698055|NCT01018680|3120828|Superiority or Other||Mean Difference (Final Values)|-0.59|||<|0.001||95.0||||First gated secondary outcome measure. Gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 secondary outcomes with sequential comparisons of treatments until outcome failed to be significant (p>0.05).|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.|||
1698056|NCT01018680|3120829|Superiority or Other||Mean Difference (Final Values)|-0.91|||<|0.001||95.0||||A 0.05 level of significance was pre-specified for use in treatment group comparisons.|Mixed Models Analysis|In Mixed Models Analysis, degrees of freedom were estimated using the Kenward-Rogers approximation.||Using a 1:1 ratio of allocation to treatment, a 2-tailed 0.05 level of significance and 80% power, 253 participants per arm had been estimated to be adequate to assess an effect size of 0.25, based on a 2-sample Student’s t-test. This derived estimate was increased slightly to 261 participants per arm to account for extremely early discontinuation that would have led to exclusion from the efficacy analysis in a small number of participants (approximately 3%).|
1698057|NCT01020487|3120830|Superiority or Other||Difference|0.3||||0.462|2-Sided|95.0|-0.53|1.12|||Mixed Models Analysis|||Week 12 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement|
1698058|NCT01020487|3120830|Superiority or Other||Difference|0.12||||0.567|2-Sided|95.0|-0.32|0.56|||Mixed Models Analysis|||Week 8 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement|
1698059|NCT01020487|3120830|Superiority or Other||Difference|-0.01||||0.975|2-Sided|95.0|-0.39|0.37|||Mixed Models Analysis|||Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.|
1698060|NCT01020487|3120830|Superiority or Other||Difference|0.14||||0.469|2-Sided|95.0|-0.25|0.53|||Mixed Models Analysis|||Overall Comparison (all time points): a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement|
1698061|NCT01020487|3120831|Superiority or Other|||||||0.194|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.|||
1698062|NCT01020487|3120832|Superiority or Other|||||||0.327|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.|||
1698063|NCT01020487|3120833|Superiority or Other||Difference|-88.52||||0.002|2-Sided|95.0|-142.04|-35.01|||Mixed Models Analysis|||Week 12 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.|
1698064|NCT01020487|3120833|Superiority or Other||Difference|-70.09||||0.043|2-Sided|95.0|-137.82|-2.37|||Mixed Models Analysis|||Week 8 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.|
1698065|NCT01020487|3120833|Superiority or Other||Difference|-68.43||||0.032|2-Sided|95.0|-130.39|-6.47|||Mixed Models Analysis|||Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.|
1698066|NCT01020487|3120833|Superiority or Other||Difference|-62.55||||0.006|2-Sided|95.0|-105.6|-19.49|||Mixed Models Analysis|||Week 2 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.|
1698067|NCT01020487|3120833|Superiority or Other||Differenbce|-72.4|||<|0.001|2-Sided|95.0|-108.05|-36.75|||Mixed Models Analysis|||Overall Comparison (all time points): A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.|
1698068|NCT01020487|3120834|Superiority or Other|||||||0.128|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.|||
1698069|NCT01020487|3120835|Superiority or Other||Difference|27.8||||0.045|2-Sided|95.0|7.5|52.8|||Fisher Exact|||Treatment effects were evaluated based on a two-sided significance level of 0.050. The primary efficacy analysis was a comparison between the paricalcitol capsules and placebo groups in the percentage of participants achieving 2 consecutive ≥ 30% reductions in iPTH from baseline regardless of CKD stage conducted using Fisher's exact test.|
1698070|NCT01018511|3120852|Superiority or Other|||||||0.019||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.|
1698071|NCT01018511|3120852|Superiority or Other||||||<|0.001||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.|
1698072|NCT01018511|3120852|Superiority or Other||||||<|0.001||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.|
1698073|NCT01018511|3120852|Superiority or Other||||||<|0.071||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.|
1698074|NCT01018511|3120852|Superiority or Other||||||<|0.11||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.|
1698075|NCT01018511|3120853|Superiority or Other|||||||0.018||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.|
1698076|NCT01018511|3120853|Superiority or Other||||||<|0.001||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.|
1698077|NCT01018511|3120853|Superiority or Other||||||<|0.001||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.|
1698078|NCT01018511|3120853|Superiority or Other||||||<|0.031||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.|
1698079|NCT01018511|3120853|Superiority or Other||||||<|0.053||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.|
1698080|NCT01018511|3120854|Superiority or Other|||||||0.058||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.|
1698081|NCT01018511|3120854|Superiority or Other||||||<|0.001||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.|
1698082|NCT01018511|3120854|Superiority or Other||||||<|0.001||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo.|
1698083|NCT01018511|3120854|Superiority or Other||||||<|0.001||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.|
1698084|NCT01018511|3120854|Superiority or Other||||||<|0.001||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS.|
1698085|NCT01018511|3120861|Superiority or Other|||||||0.407||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).|
1698086|NCT01018511|3120861|Superiority or Other|||||||0.043||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).|
1698087|NCT01018511|3120861|Superiority or Other|||||||0.324||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs placebo (superiority test).|
1698088|NCT01018511|3120861|Superiority or Other|||||||0.24||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS (superiority test).|
1698089|NCT01018511|3120861|Superiority or Other|||||||0.874||||||No adjustments for multiplicity were made.|Chi-squared|||Difference vs TOCAS (superiority test).|
1698090|NCT01018511|3120862|Superiority or Other||Least squares mean difference|1.4|Standard Error of the Mean|0.92||0.142|2-Sided|95.0|-0.5|3.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698091|NCT01018511|3120862|Superiority or Other||Least squares mean difference|3.3|Standard Error of the Mean|0.92|<|0.001|2-Sided|95.0|1.5|5.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698092|NCT01018511|3120862|Superiority or Other||Least squares mean difference|4.0|Standard Error of the Mean|0.91|<|0.001|2-Sided|95.0|2.2|5.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698093|NCT01018511|3120862|Superiority or Other||Least squares mean difference|2.0|Standard Error of the Mean|0.93|<|0.035|2-Sided|95.0|0.1|3.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698094|NCT01018511|3120862|Superiority or Other||Least squares mean difference|2.6|Standard Error of the Mean|0.92|<|0.004|2-Sided|95.0|0.8|4.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698095|NCT01018511|3120863|Superiority or Other||Least squares mean difference|0.7|Standard Error of the Mean|0.83||0.384|2-Sided|95.0|-0.9|2.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698096|NCT01018511|3120863|Superiority or Other||Least squares mean difference|2.0|Standard Error of the Mean|0.83||0.014|2-Sided|95.0|0.4|3.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.|
1698097|NCT01018511|3120863|Superiority or Other||Least squares mean difference|2.4|Standard Error of the Mean|0.82||0.003|2-Sided|95.0|0.8|4.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698098|NCT01018511|3120863|Superiority or Other||Least squares mean difference|1.3|Standard Error of the Mean|0.84||0.12|2-Sided|95.0|-0.3|3.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698099|NCT01018511|3120863|Superiority or Other||Least squares mean difference|1.7|Standard Error of the Mean|0.83||0.043|2-Sided|95.0|0.1|3.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698100|NCT01018511|3120864|Superiority or Other||Least squares mean difference|0.5|Standard Error of the Mean|1.21||0.708|2-Sided|95.0|-1.9|2.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698101|NCT01018511|3120864|Superiority or Other||Least squares mean difference|1.7|Standard Error of the Mean|1.21||0.161|2-Sided|95.0|-0.7|4.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698102|NCT01018511|3120864|Superiority or Other||Least squares mean difference|3.6|Standard Error of the Mean|1.19||0.003|2-Sided|95.0|1.2|5.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698103|NCT01018511|3120864|Superiority or Other||Least squares mean difference|1.2|Standard Error of the Mean|1.23||0.314|2-Sided|95.0|-1.2|3.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698104|NCT01018511|3120864|Superiority or Other||Least squares mean difference|3.1|Standard Error of the Mean|1.21||0.011|2-Sided|95.0|0.7|5.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698105|NCT01018511|3120865|Superiority or Other||Least squares mean difference|1.8|Standard Error of the Mean|1.06||0.092|2-Sided|95.0|-0.3|3.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698106|NCT01018511|3120865|Superiority or Other||Least squares mean difference|4.0|Standard Error of the Mean|1.06|<|0.001|2-Sided|95.0|1.9|6.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698107|NCT01018511|3120865|Superiority or Other||Least squares mean difference|4.4|Standard Error of the Mean|1.05|<|0.001|2-Sided|95.0|2.4|6.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698108|NCT01018511|3120865|Superiority or Other||Least squares mean difference|2.2|Standard Error of the Mean|1.08|<|0.043|2-Sided|95.0|0.1|4.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698109|NCT01018511|3120865|Superiority or Other||Least squares mean difference|2.6|Standard Error of the Mean|1.07|<|0.013|2-Sided|95.0|0.5|4.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698110|NCT01018511|3120866|Superiority or Other||Least squares mean difference|2.1|Standard Error of the Mean|1.16||0.068|2-Sided|95.0|-0.2|4.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698111|NCT01018511|3120866|Superiority or Other||Least squares mean difference|4.6|Standard Error of the Mean|1.15|<|0.001|2-Sided|95.0|2.3|6.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698112|NCT01018511|3120866|Superiority or Other||Least squares mean difference|5.1|Standard Error of the Mean|1.14|<|0.001|2-Sided|95.0|2.8|7.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698113|NCT01018511|3120866|Superiority or Other||Least squares mean difference|2.5|Standard Error of the Mean|1.17|<|0.035|2-Sided|95.0|0.2|4.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698114|NCT01018511|3120866|Superiority or Other||Least squares mean difference|3.0|Standard Error of the Mean|1.16|<|0.011|2-Sided|95.0|0.7|5.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs TOCAS.|
1698115|NCT01018511|3120867|Superiority or Other||Least squares mean difference|-2.6|Standard Error of the Mean|1.14||0.022|2-Sided|95.0|-4.8|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698116|NCT01018511|3120867|Superiority or Other||Least squares mean difference|-5.3|Standard Error of the Mean|1.13|<|0.001|2-Sided|95.0|-7.5|-3.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.|
1698117|NCT01018511|3120867|Superiority or Other||Least squares mean difference|-4.7|Standard Error of the Mean|1.12|<|0.001|2-Sided|95.0|-6.9|-2.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698118|NCT01018511|3120867|Superiority or Other||Least squares mean difference|-2.7|Standard Deviation|1.15|<|0.02|2-Sided|95.0|-4.9|-0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698119|NCT01018511|3120867|Superiority or Other||Least squares mean difference|-2.1|Standard Error of the Mean|1.14|<|0.068|2-Sided|95.0|-4.3|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698120|NCT01018511|3120869|Superiority or Other||Least squares mean difference|-0.1|Standard Error of the Mean|0.1||0.139|2-Sided|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698121|NCT01018511|3120869|Superiority or Other||Least squares mean difference|-0.4|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.6|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698122|NCT01018511|3120869|Superiority or Other||Least squares mean difference|-0.4|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.6|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698123|NCT01018511|3120869|Superiority or Other||Least squares mean difference|-0.2|Standard Error of the Mean|0.1|<|0.021|2-Sided|95.0|-0.4|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698124|NCT01018511|3120869|Superiority or Other||least squares mean difference|-0.3|Standard Error of the Mean|0.1|<|0.008|2-Sided|95.0|-0.5|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698125|NCT01018511|3120870|Superiority or Other||Least squares men difference|-0.9|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|-1.3|-0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698126|NCT01018511|3120870|Superiority or Other||Least squares mean difference|-0.5|Standard Error of the Mean|0.2|<|0.011|2-Sided|95.0|-0.9|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698127|NCT01018511|3120870|Superiority or Other||Least squares mean difference|-1.1|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|-1.4|-0.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698128|NCT01018511|3120870|Superiority or Other||Least squares mean difference|-0.4|Standard Error of the Mean|0.21|<|0.045|2-Sided|95.0|-0.8|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698129|NCT01018511|3120870|Superiority or Other||Least squares mean difference|-0.5|Standard Error of the Mean|0.2|<|0.009|2-Sided|95.0|-0.9|-0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698130|NCT01018511|3120871|Superiority or Other||Least squares mean difference|-0.4|Standard Error of the Mean|0.27||0.196|2-Sided|95.0|-0.9|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698131|NCT01018511|3120871|Superiority or Other||Least squares mean difference|-0.3|Standard Error of the Mean|0.27||0.317|2-Sided|95.0|-0.8|0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698132|NCT01018511|3120871|Superiority or Other||Least squares mean difference|-0.7|Standard Error of the Mean|0.27||0.01|2-Sided|95.0|-1.2|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698133|NCT01018511|3120871|Superiority or Other||Least squares mean difference|0.1|Standard Error of the Mean|0.28||0.775|2-Sided|95.0|-0.5|0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698134|NCT01018511|3120871|Superiority or Other||Least squares mean difference|-0.3|Standard Error of the Mean|0.27||0.21|2-Sided|95.0|-0.9|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698135|NCT01018511|3120872|Superiority or Other||Least squares mean difference|-0.1|Standard Error of the Mean|0.31||0.772|2-Sided|95.0|-0.7|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698232|NCT01018134|3120924|Superiority or Other|||||||0.007||||||statistically significant difference between treatment groups|t-test, 1 sided||||
1698136|NCT01018511|3120872|Superiority or Other||Least squares mean difference|-0.5|Standard Error of the Mean|0.29||0.098|2-Sided|95.0|-1.1|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698137|NCT01018511|3120872|Superiority or Other||Least squares mean difference|-0.5|Standard Error of the Mean|0.29||0.09|2-Sided|95.0|-1.1|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698138|NCT01018511|3120872|Superiority or Other||Least squares mean difference|-0.4|Standard Error of the Mean|0.31||0.203|2-Sided|95.0|-1.0|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698139|NCT01018511|3120872|Superiority or Other||Least squares mean difference|-0.4|Standard Error of the Mean|0.3||0.187|2-Sided|95.0|-1.0|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698140|NCT01018511|3120873|Superiority or Other||Least squares mean difference|-0.1|Standard Error of the Mean|0.08||0.166|2-Sided|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698141|NCT01018511|3120873|Superiority or Other||Least squares mean difference|0.0|Standard Error of the Mean|0.08||0.584|2-Sided|95.0|-0.2|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698142|NCT01018511|3120873|Superiority or Other||Least squares mean difference|-0.2|Standard Error of the Mean|0.08||0.021|2-Sided|95.0|-0.3|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698143|NCT01018511|3120873|Superiority or Other||Least squares mean difference|0.1|Standard Error of the Mean|0.08||0.402|2-Sided|95.0|-0.1|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698144|NCT01018511|3120873|Superiority or Other||Least squares mean difference|-0.1|Standard Error of the Mean|0.08||0.383|2-Sided|95.0|-0.2|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs TOCAS.|
1698145|NCT01018511|3120874|Superiority or Other||Least squares mean difference|-0.3|Standard Error of the Mean|0.23||0.215|2-Sided|95.0|-0.8|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698146|NCT01018511|3120874|Superiority or Other||Least squares mean difference|0.0|Standard Error of the Mean|0.22||0.891|2-Sided|95.0|-0.4|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo|
1698147|NCT01018511|3120874|Superiority or Other||Least squares mean difference|-0.1|Standard Error of the Mean|0.22||0.552|2-Sided|95.0|-0.6|0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698148|NCT01018511|3120874|Superiority or Other||Least squares mean difference|0.3|Standard Error of the Mean|0.24||0.182|2-Sided|95.0|-0.2|0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698149|NCT01018511|3120874|Superiority or Other||Least squares mean difference|0.2|Standard Error of the Mean|0.24||0.511|2-Sided|95.0|-0.3|0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698150|NCT01018511|3120875|Superiority or Other||Least squares mean difference|-0.4|Standard Error of the Mean|0.21||0.081|2-Sided|95.0|-0.8|0.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698151|NCT01018511|3120875|Superiority or Other||Least squares mean difference|0.0|Standard Error of the Mean|0.19||0.936|2-Sided|95.0|-0.4|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698152|NCT01018511|3120875|Superiority or Other||Least squares mean difference|-0.2|Standard Error of the Mean|0.19||0.204|2-Sided|95.0|-0.6|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698153|NCT01018511|3120875|Superiority or Other||Least squares mean difference|0.3|Standard Error of the Mean|0.21||0.102|2-Sided|95.0|-0.1|0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698154|NCT01018511|3120875|Superiority or Other||Least squares mean difference|0.1|Standard Error of the Mean|0.22||0.591|2-Sided|95.0|-0.3|0.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698155|NCT01018511|3120876|Superiority or Other||Least squares mean difference|-0.9|Standard Error of the Mean|0.25|<|0.001|2-Sided|95.0|-1.4|-0.4||No adjustments to multiplicity were made|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698323|NCT01016977|3121122|Superiority or Other|||||||0.5538||||||Week 8|ANCOVA||||
1698156|NCT01018511|3120876|Superiority or Other||Least squares mean difference|-1.2|Standard Error of the Mean|0.25|<|0.001|2-Sided|95.0|-1.7|-0.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698157|NCT01018511|3120876|Superiority or Other||Least squares mean difference|-1.0|Standard Error of the Mean|0.24|<|0.001|2-Sided|95.0|-1.5|-0.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698158|NCT01018511|3120876|Superiority or Other||Least squares mean difference|-0.3|Standard Error of the Mean|0.25|<|0.319|2-Sided|95.0|-0.7|0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698159|NCT01018511|3120876|Superiority or Other||Least squares mean difference|-0.1|Standard Error of the Mean|0.25|<|0.616|2-Sided|95.0|-0.6|0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698160|NCT01018511|3120877|Superiority or Other||Least squares mean difference|4.0|Standard Error of the Mean|7.49||0.591|2-Sided|95.0|-10.7|18.7||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698161|NCT01018511|3120877|Superiority or Other||Least squares mean difference|18.7|Standard Error of the Mean|7.45||0.012|2-Sided|95.0|4.1|33.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698162|NCT01018511|3120877|Superiority or Other||Least squares mean difference|18.5|Standard Error of the Mean|7.37||0.012|2-Sided|95.0|4.1|33.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698163|NCT01018511|3120877|Superiority or Other||Least squares mean difference|14.7|Standard Error of the Mean|7.59||0.053|2-Sided|95.0|-0.2|29.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698164|NCT01018511|3120877|Superiority or Other||Least squares mean difference|14.5|Standard Error of the Mean|7.51||0.053|2-Sided|95.0|-0.2|29.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698165|NCT01018511|3120878|Superiority or Other||Least squares mean difference|4.4|Standard Error of the Mean|3.32||0.189|2-Sided|95.0|-2.2|10.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.|
1698166|NCT01018511|3120878|Superiority or Other||Least squares mean difference|27.6|Standard Error of the Mean|3.3|<|0.001|2-Sided|95.0|21.1|34.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698167|NCT01018511|3120878|Superiority or Other||Least squares mean difference|27.4|Standard Error of the Mean|3.27|<|0.001|2-Sided|95.0|21.0|33.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698168|NCT01018511|3120878|Superiority or Other||Least squares mean difference|23.2|Standard Error of the Mean|3.36|<|0.001|2-Sided|95.0|16.6|29.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698169|NCT01018511|3120878|Superiority or Other||Least squares mean difference|23.1|Standard Error of the Mean|3.33|<|0.001|2-Sided|95.0|16.6|29.6||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698170|NCT01018511|3120879|Superiority or Other||least squares mean difference|-0.5|Standard Error of the Mean|0.17||0.002|2-Sided|95.0|-0.9|-0.2||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698171|NCT01018511|3120879|Superiority or Other||Least squares mean difference|-0.7|Standard Error of the Mean|0.17|<|0.001|2-Sided|95.0|-1.1|-0.4||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate||Mean change vs placebo.|
1698172|NCT01018511|3120879|Superiority or Other||Least squares mean difference|-1.2|Standard Error of the Mean|0.17|<|0.001|2-Sided|95.0|-1.5|-0.8||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs placebo.|
1698173|NCT01018511|3120879|Superiority or Other||Least squares mean difference|-0.2|Standard Error of the Mean|0.17|<|0.223|2-Sided|95.0|-0.6|0.1||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698174|NCT01018511|3120879|Superiority or Other||Least squares mean difference|-0.6|Standard Error of the Mean|0.17|<|0.001|2-Sided|95.0|-1.0|-0.3||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||Mean change vs TOCAS.|
1698175|NCT01018511|3120880|Superiority or Other||Least squares mean difference|-2.3|Standard Error of the Mean|0.64|<|0.001|2-Sided|95.0|-3.5|-1.0||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of TOCAS vs. placebo on the change from baseline to end of treatment in TUS.|
1698176|NCT01018511|3120880|Superiority or Other||Least squares mean difference|-3.2|Standard Error of the Mean|0.63|<|0.001|2-Sided|95.0|-4.4|-1.9||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/9 mg vs. placebo on the change from baseline to end of treatment in TUS.|
1698177|NCT01018511|3120880|Superiority or Other||Least Squares Mean Difference|-3.7|Standard Error of the Mean|0.62|<|0.001|2-Sided|95.0|-4.9|-2.5||No adjustments to multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC 0.4 mg/6 mg vs. placebo on the change from baseline to end of treatment in TUS.|
1698178|NCT01018511|3120880|Superiority or Other||Least squares mean difference|-0.9|Standard Error of the Mean|0.64|<|0.162|2-Sided|97.5|-2.3|0.5||The primary analysis was adjusted for multiplicity for TUS using the Hochberg procedure.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||"The superiority of FDC 0.4 mg/6 mg vs. TOCAS in the change from baseline to end of treatment in TUS.~A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS."|
1698179|NCT01018511|3120880|Superiority or Other||Least squares mean difference|-1.4|Standard Error of the Mean|0.64|<|0.025|2-Sided|97.5|-2.9|0.0||The primary analysis was adjusted for multiplicity for TUS using the Hochberg procedure.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||"The superiority of FDC 0.4 mg/6 mg vs. TOCAS in the change from baseline to end of treatment in TUS.~A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS."|
1698180|NCT01018511|3120881|Superiority or Other||Least Squares Mean Difference|-0.8|Standard Error of the Mean|0.41||0.039|2-Sided|95.0|-1.6|0.0||No adjustments for multiplicity were made.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of TOCAS vs. placebo on the change from baseline to end of treatment in total IPSS. With a sample size of 274 participants per arm, the overall power to meet this outcome measure was 97% power for superiority vs placebo for total IPSS.|
1698181|NCT01018511|3120881|Superiority or Other||Least Squares Mean Difference|-1.1|Standard Error of the Mean|0.41||0.006|2-Sided|95.0|-1.9|-0.3||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||"The superiority of the FDC vs. placebo on the change from baseline to end of treatment in total IPSS.~A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS."|
1698182|NCT01018511|3120881|Superiority or Other||Least Squares Mean Difference|-1.6|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-2.4|-0.9||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||"The superiority of the FDC vs placebo on the change from baseline to end of treatment in total IPSS.~A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS."|
1698183|NCT01018511|3120881|Superiority or Other||||||<|0.483||||||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS.|
1698184|NCT01018511|3120881|Superiority or Other||||||<|0.048||||||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||The superiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS.|
1698185|NCT01018511|3120881|Non-Inferiority or Equivalence|Only the FDC(s) that succeeded in stage 1 were evaluated in stage 2 for total IPSS. If both FDCs succeeded in stage 1, then both FDCs proceeded to stage 2 and the Hochberg procedure was implemented at one-sided alpha = 0.025. If one FDC succeeded in stage 1, then only this FDC proceeded to stage 2 and the FDC vs. TOCAS alone for non-inferiority was assessed at one-sided alpha = 0.025/2 = 0.0125.|Least Squares Mean Difference|-0.3|Standard Error of the Mean|0.41|<|0.028|2-Sided|97.5|-1.22|0.64||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||"The non-inferiority of FDC vs. TOCAS on the change from baseline to end of treatment in total IPSS.~A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS."|
1698233|NCT01018134|3120924|Superiority or Other|||||||0.0361||||||statistically significant difference between treatment groups|t-test, 1 sided||||
1698234|NCT01018134|3120924|Superiority or Other|||||||0.0186||||||statistically significant difference between treatment groups|t-test, 1 sided||||
1698235|NCT01018134|3120924|Superiority or Other|||||||0.2968|||||||t-test, 1 sided||||
1698236|NCT01018134|3120924|Superiority or Other|||||||0.2631|||||||t-test, 1 sided||||
1698237|NCT01018134|3120925|Superiority or Other|||||||0.12|||||||t-test, 1 sided||||
1698238|NCT01018134|3120925|Superiority or Other|||||||0.2103|||||||t-test, 1 sided||||
1698324|NCT01016977|3121122|Superiority or Other|||||||0.9852||||||Week 4|ANCOVA||||
1698186|NCT01018511|3120881|Non-Inferiority or Equivalence|Overall power was 90% power for non-inferiority vs placebo for total IPSS. Only the FDC(s) that succeeded in stage 1 were evaluated in stage 2 for total IPSS. If both FDCs succeeded in stage 1, then both FDCs proceeded to stage 2 and the Hochberg procedure was implemented at one-sided alpha = 0.025. If one FDC succeeded in stage 1, then only this FDC proceeded to stage 2 and the FDC vs. TOCAS alone for non-inferiority was assessed at one-sided alpha = 0.025/2 = 0.0125.|Least Squares Mean Difference|-0.8|Standard Error of the Mean|0.41|<|0.001|2-Sided|97.5|-1.73|0.11||The primary analysis was adjusted for multiplicity for IPSS using the Hochberg procedure involving 2 stages: Stage 1, superiority to placebo and Stage 2: non-inferiority to tamsulosin alone, with a switch to superiority where applicable.|Mixed Models Analysis|A mixed model, including treatment group and country as fixed factors, center as a random effect, and baseline as a covariate.||"The non-inferiority of FDC vs TOCAS on the change from baseline to end of treatment in total IPSS.~A FDC was regarded successful if it showed superiority vs. placebo for total IPSS, noninferiority vs. TOCAS alone for total IPSS along with superiority vs. TOCAS alone for TUS."|
1698187|NCT01018394|3120888|Superiority or Other||Odds Ratio (OR)|1.9||||0.108|2-Sided|95.0|0.7|5.1||A one tailed P of less than 0.2 was considered sufficient evidence to warrant a larger study.|Fisher Exact|1 tailed||The percentage of participants who reduced tobacco use by greater or equal to 50% from baseline was compared between groups using Fisher's exact test. A one tailed P of less than 0.2 was considered sufficient evidence to warrant a larger study.|
1698188|NCT01018264|3120889|Superiority or Other||Effect size|0.11||||0.94|2-Sided||||||ANCOVA||||
1698189|NCT01018264|3120890|Superiority or Other||Effect size|0.27||||0.47|2-Sided||||||ANCOVA||||
1698190|NCT01018264|3120891|Superiority or Other||Effect size|0.35||||0.22|2-Sided||||||ANCOVA||||
1698191|NCT01018264|3120892|Superiority or Other||Effect size|0.53||||0.01|2-Sided||||||ANCOVA||||
1698192|NCT01018264|3120893|Superiority or Other||Effect size|0.2||||0.53|2-Sided||||||ANCOVA|Adjusted for baseline value|This represents the effect size between solifenacin and placebo.||
1698193|NCT01018186|3120907|Superiority or Other||Ratio of LSGM to Baseline|1.09||||0.444|2-Sided|95.0|0.87|1.38|||ANCOVA||||
1698194|NCT01018186|3120907|Superiority or Other||Ratio of LSGM to Baseline|1.05||||0.674|2-Sided|95.0|0.83|1.33|||ANCOVA||||
1698195|NCT01018186|3120908|Superiority or Other||Ratio of LSGM to Baseline|1.43||||0.006|2-Sided|95.0|1.11|1.84|||ANCOVA||||
1698196|NCT01018186|3120908|Superiority or Other||Ratio of LSGM to Baseline|1.65|||<|0.001|2-Sided|95.0|1.29|2.13|||ANCOVA||||
1698197|NCT01018186|3120909|Superiority or Other||Ratio of LSGM to Baseline|1.52|||<|0.001|2-Sided|95.0|1.22|1.89|||ANCOVA||||
1698198|NCT01018186|3120909|Superiority or Other||Ratio of LSGM to Baseline|1.67|||<|0.001|2-Sided|95.0|1.34|2.08|||ANCOVA||||
1698199|NCT01018186|3120910|Superiority or Other||Ratio|1.09|||||2-Sided|95.0|0.87|1.38|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 52||
1698200|NCT01018186|3120910|Superiority or Other||Ratio|1.43|||||2-Sided|95.0|1.11|1.84|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 28||
1698201|NCT01018186|3120910|Superiority or Other||Ratio|1.52|||||2-Sided|95.0|1.22|1.89|||||Ratio of FF/VI 200/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 12||
1698202|NCT01018186|3120910|Superiority or Other||Ratio|1.05|||||2-Sided|95.0|0.83|1.33|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 52||
1698203|NCT01018186|3120910|Superiority or Other||Ratio|1.65|||||2-Sided|95.0|1.29|2.13|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 28||
1698204|NCT01018186|3120910|Superiority or Other||Ratio|1.67|||||2-Sided|95.0|1.34|2.08|||||Ratio of FF/VI 100/25 OD versus FP 500 BD to Baseline of 24-Hour Urinary Cortisol Excretion at Week 12||
1698205|NCT01018134|3120921|Superiority or Other|||||||0.2162|||||||Wilcoxon (Mann-Whitney)||||
1698206|NCT01018134|3120921|Superiority or Other|||||||0.0363|||||||Wilcoxon (Mann-Whitney)||||
1698207|NCT01018134|3120921|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1698208|NCT01018134|3120921|Superiority or Other|||||||0.1892|||||||Wilcoxon (Mann-Whitney)||||
1698209|NCT01018134|3120921|Superiority or Other|||||||0.0154|||||||Wilcoxon (Mann-Whitney)||||
1698210|NCT01018134|3120921|Superiority or Other|||||||0.0383|||||||Wilcoxon (Mann-Whitney)||||
1698211|NCT01018134|3120921|Superiority or Other|||||||0.3794|||||||Wilcoxon (Mann-Whitney)||||
1698212|NCT01018134|3120921|Superiority or Other|||||||0.2397|||||||Wilcoxon (Mann-Whitney)||||
1698213|NCT01018134|3120922|Superiority or Other|||||||0.1924|||||||Wilcoxon (Mann-Whitney)||||
1698214|NCT01018134|3120922|Superiority or Other|||||||0.223|||||||Wilcoxon (Mann-Whitney)||||
1698215|NCT01018134|3120922|Superiority or Other|||||||0.0093|||||||Wilcoxon (Mann-Whitney)||||
1698216|NCT01018134|3120922|Superiority or Other|||||||0.0297|||||||Wilcoxon (Mann-Whitney)||||
1698217|NCT01018134|3120922|Superiority or Other|||||||0.0528|||||||Wilcoxon (Mann-Whitney)||||
1698218|NCT01018134|3120922|Superiority or Other|||||||0.1328|||||||Wilcoxon (Mann-Whitney)||||
1698219|NCT01018134|3120922|Superiority or Other|||||||0.2664|||||||Wilcoxon (Mann-Whitney)||||
1698220|NCT01018134|3120922|Superiority or Other|||||||0.2442|||||||Wilcoxon (Mann-Whitney)||||
1698221|NCT01018134|3120923|Superiority or Other|||||||0.0749|||||||Wilcoxon (Mann-Whitney)||||
1698222|NCT01018134|3120923|Superiority or Other|||||||0.4967|||||||Wilcoxon (Mann-Whitney)||||
1698223|NCT01018134|3120923|Superiority or Other|||||||0.0033|||||||Wilcoxon (Mann-Whitney)||||
1698224|NCT01018134|3120923|Superiority or Other|||||||0.1126|||||||Wilcoxon (Mann-Whitney)||||
1698225|NCT01018134|3120923|Superiority or Other|||||||0.0309|||||||Wilcoxon (Mann-Whitney)||||
1698226|NCT01018134|3120923|Superiority or Other|||||||0.0419|||||||Wilcoxon (Mann-Whitney)||||
1698227|NCT01018134|3120923|Superiority or Other|||||||0.2689|||||||Wilcoxon (Mann-Whitney)||||
1698228|NCT01018134|3120923|Superiority or Other|||||||0.2713|||||||Wilcoxon (Mann-Whitney)||||
1698229|NCT01018134|3120924|Superiority or Other|||||||0.2878|||||||t-test, 1 sided||||
1698230|NCT01018134|3120924|Superiority or Other|||||||0.2078|||||||t-test, 1 sided||||
1698239|NCT01018134|3120925|Superiority or Other|||||||0.01||||||Statistically significant difference between treatment groups|t-test, 1 sided||||
1698240|NCT01018134|3120925|Superiority or Other|||||||0.3421|||||||t-test, 1 sided||||
1698241|NCT01018134|3120925|Superiority or Other|||||||0.009||||||Statistically significant difference between treatment groups|t-test, 1 sided||||
1698242|NCT01018134|3120925|Superiority or Other|||||||0.1826|||||||t-test, 1 sided||||
1698243|NCT01018134|3120925|Superiority or Other|||||||0.4219|||||||t-test, 1 sided||||
1698244|NCT01018134|3120925|Superiority or Other|||||||0.4261|||||||t-test, 1 sided||||
1698245|NCT01018095|3120926|Non-Inferiority or Equivalence|Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at 3 months was calculated as a relative risk with 95% confidence interval.|Risk Ratio (RR)|0.46|Standard Error of the Mean|0.196|=|0|2-Sided|95.0|0.21|0.98|||Relative risk|The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.||It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.|
1698246|NCT01018095|3120927|Non-Inferiority or Equivalence|It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.|Risk Ratio (RR)|0.46|Standard Deviation|1.0|<|0.05|2-Sided|95.0|0.21|0.98||Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test.|Chi-squared||||
1698247|NCT01018095|3120927|Non-Inferiority or Equivalence|Continuous variables were assessed for normality, and tested accordingly. When appropriate, continuous variables were categorized using clinically relevant cut-points. Categorical variables were compared using the Chi-square test. The measure of association at TOC was calculated as a relative risk with 95% confidence interval.|Risk Ratio (RR)|0.5|Standard Error of the Mean|0.191|<|0.045|2-Sided|95.0|0.25|1.0|||Relative risk|The measure of association at TOC and 3 months was calculated as a relative risk with 95% confidence interval.||It was initially estimated that a total of 380 participants (190 per arm) would be required, with 90% power and a significance level of 5%, to establish equivalency between the two treatment arms.31 Enrollment rates were lower than estimated and only 270 participants (135 per arm) were enrolled.|
1698248|NCT01018030|3120955|Superiority or Other||Least Squares Mean Difference|-0.357||||0.014|2-Sided|95.0|-0.64|-0.07|||ANCOVA||The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.||
1698249|NCT01018030|3120955|Superiority or Other||Least Squares Mean Difference|-0.386||||0.008|2-Sided|95.0|-0.67|-0.1|||ANCOVA||The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender.||
1698250|NCT01017952|3120956|Superiority or Other||Least squares mean difference|0.026||||0.115|2-Sided|95.0|-0.006|0.057|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1698251|NCT01017952|3120956|Superiority or Other||Least squares mean difference|0.024||||0.143|2-Sided|95.0|-0.008|0.056|||Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1698252|NCT01017952|3120956|Superiority or Other||Least squares mean difference|0.034||||0.034|2-Sided|95.0|0.003|0.066||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1698253|NCT01017952|3120957|Superiority or Other||Risk Ratio (RR)|0.65|||<|0.001|2-Sided|95.0|0.51|0.84|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable|||
1698254|NCT01017952|3120957|Superiority or Other||Risk Ratio (RR)|0.77|||<|0.041|2-Sided|95.0|0.6|0.99|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable|||
1698255|NCT01017952|3120957|Superiority or Other||Risk Ratio (RR)|0.84|||<|0.154|2-Sided|95.0|0.65|1.07|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.|||
1698256|NCT01017952|3120958|Superiority or Other||Hazard Ratio (HR)|0.66|||<|0.001|2-Sided|95.0|0.54|0.82|||Regression, Cox||||
1698257|NCT01017952|3120958|Superiority or Other||Hazard Ratio (HR)|0.88|||<|0.036|2-Sided|95.0|0.66|0.99|||Regression, Cox||||
1698258|NCT01017952|3120958|Superiority or Other||Hazard Ratio (HR)|0.87|||<|0.177|2-Sided|95.0|0.71|1.06|||Regression, Cox||||
1698259|NCT01017952|3120959|Superiority or Other||Risk Ratio (RR)|0.69|||<|0.001|2-Sided|95.0|0.56|0.85|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.|||
1698260|NCT01017952|3120959|Superiority or Other||Risk Ratio (RR)|0.79|||<|0.024|2-Sided|95.0|0.64|0.97|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.|||
1698261|NCT01017952|3120959|Superiority or Other||Risk Ratio (RR)|0.81|||<|0.04|2-Sided|95.0|0.66|0.99|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.|||
1698262|NCT01017874|3120961|Superiority or Other||Hazard Ratio (HR)|0.84||||0.952|2-Sided|95.0|0.53|1.32|||Wilcoxon (Mann-Whitney)||||
1698263|NCT01017874|3120962|Superiority or Other||Hazard Ratio (HR)|0.85||||0.252|2-Sided|95.0|0.63|1.14|||Wilcoxon (Mann-Whitney)||||
1698264|NCT01017874|3120965|Superiority or Other||Hazard Ratio (HR)|0.94||||0.788|2-Sided|95.0|0.68|1.31|||Wilcoxon (Mann-Whitney)||||
1698265|NCT01017874|3120966|Superiority or Other||Hazard Ratio (HR)|0.85||||0.217|2-Sided|95.0|0.63|1.13|||Wilcoxon (Mann-Whitney)||||
1698266|NCT01017731|3120980|Superiority or Other|||||||0.0161||||||The p-value for QTc interval prolongation compared to baseline.|Mixed Models Analysis||||
1698267|NCT01017601|3120988|Other|||||||1|||||||Fisher Exact||||
1698268|NCT01017601|3120989|Other|||||||0.54|||||||Fisher Exact||||
1698269|NCT01017601|3120990|Other|||||||0.96|||||||Wilcoxon Rank Sum||||
1698270|NCT01017601|3120991|Other|||||||0.5|||||||Wilcoxon Rank Sum||||
1698271|NCT01017250|3121017|Superiority or Other|||||||0.34|||||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.|
1698272|NCT01017250|3121018|Superiority or Other|||||||0.76|||||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.|
1698273|NCT01017250|3121019|Superiority or Other|||||||0.002|||||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.|
1698274|NCT01017250|3121020|Superiority or Other|||||||0.53|||||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.|
1698275|NCT01017250|3121021|Superiority or Other|||||||0.0005|||||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.|
1698276|NCT01017250|3121022|Superiority or Other|||||||0.02|||||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.|
1698277|NCT01017250|3121023|Superiority or Other|||||||0.002|||||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.|
1698278|NCT01017250|3121024|Superiority or Other|||||||0.04|||||||Wilcoxon signed rank|||This was a test on the change from baseline to the post-SRS time point for all patients.|
1698279|NCT01017146|3121071|Superiority or Other||Percentage of participants|16.1|||||2-Sided|95.0|12.4|19.9|||||The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.||
1698280|NCT01017146|3121071|Superiority or Other||Percentage of participants|28.8|||<|0.001|2-Sided|95.0|24.2|33.5|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.||
1698281|NCT01017146|3121072|Superiority or Other||Percentage of participants|23.9|||||2-Sided|95.0|19.6|28.3|||||The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.||
1698282|NCT01017146|3121072|Superiority or Other||Percentage of participants|35.6|||<|0.001|2-Sided|95.0|30.7|40.5|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.||
1698283|NCT01017146|3121073|Superiority or Other||||||<|0.001||||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs|ANCOVA||||
1698284|NCT01017146|3121073|Superiority or Other||||||<|0.001||||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs|ANCOVA||||
1698285|NCT01017146|3121073|Superiority or Other||||||<|0.001||||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs|ANCOVA||||
1698286|NCT01017120|3121093|Superiority or Other||Percentage of participants|13.3|||||2-Sided|95.0|9.8|16.7|||||The estimated value represents the percentage of participants receiving vehicle foam with an ISGA score of 0 or 1 at Week 12.||
1698287|NCT01017120|3121093|Superiority or Other||Percentage of participants|27.6|||<|0.001|2-Sided|95.0|23.1|32.2|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with an ISGA score of 0 or 1 at Week 12.||
1698288|NCT01017120|3121094|Superiority or Other||Percentage of participants|18.2|||||2-Sided|95.0|14.2|22.1|||||The estimated value represents the percentage of participants receiving vehicle foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.||
1698289|NCT01017120|3121094|Superiority or Other||Percentage of participants|32.2|||<|0.001|2-Sided|95.0|27.4|36.9|||Cochran-Mantel-Haenszel||The estimated value represents the percentage of participants receiving tazarotene foam with a minimum 2 G improvement in the ISGA score from Baseline at Week 12.||
1698290|NCT01017120|3121095|Superiority or Other||||||<|0.001||||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs|ANCOVA||||
1698291|NCT01017120|3121095|Superiority or Other||||||<|0.001||||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for NILs|ANCOVA||||
1698292|NCT01017120|3121095|Superiority or Other||||||<|0.001||||||The p-value indicates treatment differences between tazarotene foam and vehicle foam for ILs|ANCOVA||||
1698293|NCT01017029|3121100|Superiority or Other||Hazard Ratio (HR)|1.403||||0.1966|2-Sided|95.0|0.839|2.347|||Regression, Cox||||
1698294|NCT01017029|3121101|Superiority or Other|||||||0.0234|||||||Fisher Exact|||CMV infections|
1698295|NCT01017029|3121103|Superiority or Other||Hazard Ratio (HR)|1.847||||0.0398|2-Sided|95.0|1.029|3.315|||Regression, Cox||||
1698296|NCT01017029|3121105|Superiority or Other||Hazard Ratio (HR)|1.482||||0.1043|2-Sided|95.0|0.922|2.383|||Regression, Cox||||
1698297|NCT01016977|3121117|Superiority or Other|||||||0.1679||||||Week 12|ANCOVA||||
1698298|NCT01016977|3121117|Superiority or Other|||||||0.8809||||||Week 8|ANCOVA||||
1698299|NCT01016977|3121117|Superiority or Other|||||||0.9816||||||Week 4|ANCOVA||||
1698300|NCT01016977|3121117|Superiority or Other|||||||0.9743||||||Week 2|ANCOVA||||
1698301|NCT01016977|3121117|Superiority or Other|||||||0.725||||||Week 1|ANCOVA||||
1698302|NCT01016977|3121118|Superiority or Other|||||||0.3461||||||Week 12|ANCOVA||||
1698303|NCT01016977|3121118|Superiority or Other|||||||0.2349||||||Week 8|ANCOVA||||
1698304|NCT01016977|3121118|Superiority or Other|||||||0.5951||||||Week 4|ANCOVA||||
1698305|NCT01016977|3121118|Superiority or Other|||||||0.8662||||||Week 2|ANCOVA||||
1698306|NCT01016977|3121118|Superiority or Other|||||||0.4037||||||Week 1|ANCOVA||||
1698307|NCT01016977|3121119|Superiority or Other|||||||0.2556||||||Week 12|ANCOVA||||
1698308|NCT01016977|3121119|Superiority or Other|||||||0.5523||||||Week 8|ANCOVA||||
1698309|NCT01016977|3121119|Superiority or Other|||||||0.9291||||||Week 4|ANCOVA||||
1698310|NCT01016977|3121119|Superiority or Other|||||||0.0963||||||Week 2|ANCOVA||||
1698311|NCT01016977|3121119|Superiority or Other|||||||0.401||||||Week 1|ANCOVA||||
1698312|NCT01016977|3121120|Superiority or Other|||||||0.2927||||||Week 12|ANCOVA||||
1698313|NCT01016977|3121120|Superiority or Other|||||||0.9252||||||Week 8|ANCOVA||||
1698314|NCT01016977|3121120|Superiority or Other|||||||0.0259||||||Week 4|ANCOVA||||
1698325|NCT01016977|3121122|Superiority or Other|||||||0.2293||||||Week 2|ANCOVA||||
1698326|NCT01016977|3121122|Superiority or Other|||||||0.5961||||||Week 1|ANCOVA||||
1698327|NCT01016977|3121123|Superiority or Other|||||||0.7917||||||Week 12|ANCOVA||||
1698328|NCT01016977|3121123|Superiority or Other|||||||0.5655||||||Week 8|ANCOVA||||
1698329|NCT01016977|3121123|Superiority or Other|||||||0.6315||||||Week 4|ANCOVA||||
1698330|NCT01016977|3121123|Superiority or Other|||||||0.5538||||||Week 2|ANCOVA||||
1698331|NCT01016977|3121123|Superiority or Other|||||||0.9597||||||Week 1|ANCOVA||||
1698332|NCT01016834|3121150|Superiority or Other|||||||0.0007|||||||t-test, 2 sided|||For the primary analyses and other PPMQ-R variables, the mean of the differences between each subject’s rating of overall treatment satisfaction at the end of study based on the subject’s experience using Sumavel DosePro and the rating at baseline based on the subject’s pre-study triptan treatment were compared using a two-sided paired t-test at the 5% level of significance|
1698333|NCT01016678|3121163|Superiority or Other||difference in percentages|8.0||||0.1294|2-Sided||||||Chi-squared||||
1698334|NCT01016678|3121164|Superiority or Other||Difference in percentages|18.0||||0.0038|2-Sided||||||Chi-squared|||Comparison of percentage of participants pain free at 2 hours post-dose (active) to percentage of participants pain free at 2 hours post-dose (placebo)|
1698335|NCT01016652|3121169|Non-Inferiority or Equivalence|The non-inferiority margin will be exceeded if the test lens is greater than or equal to 0.25D over the control lens.|Mean Difference (Net)|0.01|Standard Error of the Mean|0.06|||2-Sided|95.0|-0.09|0.1||||||"Ho: There is not a difference between the test lens and the control lens for amplitude of accommodation.~Ha: Monocular amplitude of accommodation of the test lens is significantly better than the control lens"|
1698336|NCT01016652|3121170|Non-Inferiority or Equivalence|This is a non-inferiority analysis, with >=5 CLUE points being the non-inferiority margin.|Mean Difference (Final Values)|-4.14|Standard Error of the Mean|0.12|||2-Sided|95.0|-9.86|1.59||||||"Ho: There are not significant differences between the two lenses (etafilcon A multifocal (test) vs. etafilcon A sphere (control)for Vision quality.~Ha: The test lens is greater than or equal by 5 CLUE points than the control lense."|
1698337|NCT01016353|3121215|Superiority|||||||0.06|||||||Log Rank||||
1698338|NCT01016262|3121220|Superiority or Other (legacy)|||||||0.0346||||||Statistical significance was assessed at the two-sided 5% level. As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Cochran-Mantel-Haenszel|||The comparison between Canasa® and placebo during the DB phase with respect to the primary outcome measure was a pre-specified tertiary analysis only.|
1698339|NCT01016262|3121220|Superiority or Other (legacy)|||||||0.0047||||||Statistical significance was assessed at the two-sided 5% level. As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.|Cochran-Mantel-Haenszel|||The comparison between MAX-002 and placebo during the DB phase with respect to the primary outcome measure was the single pre-specified primary analysis, and the null hypothesis was that the percentages were equal between the two groups.|
1698340|NCT01015833|3121234|Superiority||Hazard Ratio (HR)|0.9||||0.98|2-Sided|95.0|0.72|1.2|||t-test, 1 sided||||
1698341|NCT01015833|3121236|Superiority||Hazard Ratio (HR)|1.06||||0.24|2-Sided|95.0|0.8|1.4|||t-test, 1 sided||||
1698342|NCT01015820|3121237|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Statistical significance p ≤ 0.05|
1698343|NCT01015820|3121238|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Statistical significance p ≤ 0.05|
1698344|NCT01015807|3121239|Other|||||||0.48|||||||ANOVA|||We estimated that 25 subjects per group would allow us to detect a reduction of this area from 7.5 cm2 in our placebo group to 3.5 cm2 in the CloTAP group, with SD = 5 cm2 in both groups, owing to improved overall analgesia and reduced pain sensitization in women allocated to receive a TAP block with clonidine (2-tailed [alpha] = 0.05, 80% power). To allow for failed TAP blocks and/or exclusions of cases, we included 30 patients per group (n = 90)|
1698345|NCT01015677|3121242|Superiority or Other||Difference in the LS means|-14.52||||0.001|2-Sided|90.0|-21.73|-7.32|||ANCOVA|ANCOVA with terms for treatment, region, stage of the trial, and baseline value as a covariate in PP population only.|||
1698346|NCT01015677|3121242|Superiority or Other||Difference in LS means|0.94||||0.827|2-Sided|90.0|-6.19|8.07|||ANCOVA|Analysis of covariance (ANCOVA) with terms for treatment, region, stage of the trial, and baseline value as a covariate in PP population only.|||
1698347|NCT01015677|3121243|Superiority or Other||Difference in the least squares means|-11.22||||0.264|2-Sided|95.0|-31.03|8.59|||Longitudinal Data Analysis|LDA model includes terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.|||
1698348|NCT01015677|3121243|Superiority or Other||Differrence in the least squares means|-6.05||||0.529|2-Sided|95.0|-25.06|12.96|||Longitudinal Data Analysis (LDA)|LDA model includes terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.|||
1698349|NCT01015677|3121246|Superiority or Other||Difference in the least squares means|-17.45||||0.069|2-Sided|95.0|-36.28|1.38|||Longitudinal Data Analysis|LDA model with terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.|||
1698350|NCT01015677|3121246|Superiority or Other||Differrence in the least squares means|-6.28||||0.488|2-Sided|95.0|-24.2|11.64|||Longitudinal Data Analysis (LDA)|LDA model terms for treatment, week (Weeks 1, 2 and 4), region, and interaction of treatment by week.|||
1698351|NCT01015638|3121255|Superiority or Other||||||>|0.05|||||||Tukey-Kramer Multiple Comparisons Test||||
1698352|NCT01015638|3121256|Superiority or Other||||||>|0.05|||||||Kruskal-Wallis||||
1698353|NCT01015638|3121257|Superiority or Other||||||>|0.05|||||||Dunn's Multiple Comparisons Test||||
1698354|NCT01015638|3121258|Superiority or Other||||||>|0.05|||||||Kruskal-Wallis||||
1698355|NCT01015534|3121275|Superiority or Other|||||||0.84|||||||Log Rank||||
1698356|NCT01015534|3121276|Superiority or Other||Odds Ratio (OR)|0.688||||0.704|2-Sided|95.0|0.138|3.422|||Fisher Exact||||
1698357|NCT01015534|3121277|Superiority or Other||Odds Ratio (OR)|3.9||||0.019|2-Sided|95.0|1.3|12.9||The sample size was calculated with a two-sided test,a type-I error probability of 0.05 and a power of 0.80,Twenty- eight patients in each treatment arm were required to detect a difference in ORR of 0.29|Chi-squared||||
1698358|NCT01015443|3121283|Superiority or Other||Hazard Ratio (HR)|1.032||||0.921|2-Sided|95.0|0.552|1.931|||Adjusted log rank||||
1698359|NCT01015131|3121308|Superiority or Other||Mean Difference (Final Values)|0.1521|||<|0.01|2-Sided|90.0|0.0932|0.2111|||paired t-test||||
1698360|NCT01015118|3121310|Superiority or Other||Mean Difference (Net)|-1.88|Standard Error of the Mean|0.75||0.0124|2-Sided|95.0|-3.35|-0.41|||Mixed effect growth curve model|Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.|Mean difference calculated is the Adjusted mean. High values represent a better level of functioning. Difference calculated as nintedanib minus placebo.|Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB−III vs IV), and carboplatin level (AUC5 vs. AUC6).|
1698361|NCT01015118|3121311|Superiority or Other||Mean Difference (Net)|5.29|Standard Error of the Mean|0.72|<|0.0001|2-Sided|95.0|3.88|6.69|||Mixed effect growth curve model|Mixed-effects growth curve models (longitudinal models) with the average profile over time for each endpoint described by a piecewise linear model.|Mean difference presented is the Adjusted mean difference. Difference calculated as nintedanib minus placebo. High values represent a worse level of symptoms.|Adjusted for the stratification factors macroscopic residual postoperative tumour at baseline (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB−III vs IV), and carboplatin level (AUC5 vs. AUC6).|
1698362|NCT01015118|3121312|Superiority or Other||Odds Ratio (OR)|1.22||||0.349|2-Sided|95.0|0.81|1.82|||Regression, Logistic||An odds ratio >1 favours nintedanib.|Odds ratio and p−value are obtained from logistic regression model adjusting for, macroscopic residual postoperative tumour (yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) stage (IIB−III vs. IV) and carboplatin level (AUC5 vs. AUC6).|
1698363|NCT01015118|3121313|Superiority or Other||Hazard Ratio (HR)|0.88||||0.0749|2-Sided|95.0|0.77|1.01|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).|
1698364|NCT01015118|3121314|Superiority or Other||Hazard Ratio (HR)|0.99||||0.8653|2-Sided|95.0|0.83|1.17|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).|
1698365|NCT01015118|3121315|Superiority or Other||Hazard Ratio (HR)|0.85||||0.0256|2-Sided|95.0|0.74|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).|
1698366|NCT01015118|3121316|Superiority or Other||Hazard Ratio (HR)|0.83||||0.0186|2-Sided|95.0|0.72|0.97|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|HR, CI and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).|
1698367|NCT01015118|3121317|Superiority or Other||Hazard Ratio (HR)|0.86||||0.0286|2-Sided|95.0|0.75|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level (AUC5 vs. AUC6).|
1698368|NCT01015118|3121318|Superiority or Other||Hazard Ratio (HR)|0.84||||0.0239|2-Sided|95.0|0.72|0.98|||Log Rank|Breslow method was used for handling ties.|If hazard ratio is below 1 then favours nintedanib.|Hazard ratio (HR), Confidence Interval (CI) and P-value obtained from a proportional-hazards model stratified by Macroscopic residual postoperative tumour (Yes vs. no), the International Federation of Gynecology and Obstetrics (FIGO) Stage (IIB-III vs. IV) and carboplatin level Area under curve 5 (AUC5) vs. Area under curve 6 (AUC6).|
1698369|NCT01014910|3121412|Superiority or Other|||||||0.05|||||||Chi-squared, Corrected|||The proportion of patients transferred to the intensive care unit in each study arm was compared between study arms using the Pearson χ2 test. All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).|
1698370|NCT01014910|3121413|Superiority or Other||||||<|0.05||||||Based on a previously-identified mean LOS of 65.3 hours, we estimated we would need to enroll 80 patients in each study arm to provide adequate sample size to detect a difference in mean LOS of 18 hours with 80% power and alpha=0.05.|Wilcoxon (Mann-Whitney)|Sample size calculations were performed using Power and Sample Size Calculator, version 3.0 (by developers William D. Dupont and Walton D. Plummer Jr)||Differences in LOS were compared between study arms using the Mann-Whitney U-test and the Kaplan-Meier method. Statistical analyses were performed using Stata version 13.1 for Windows (StataCorp). All patients enrolled in the study, including those who subsequently had consent for the intervention withdrawn, were included for analysis (intention to treat).|
1698371|NCT01014728|3121421|Superiority or Other|||||||0.461|||||||Wilcoxon (Mann-Whitney)||||
1698372|NCT01014728|3121422|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1698373|NCT01014728|3121423|Superiority or Other|||||||0.937|||||||t-test, 2 sided||||
1698374|NCT01014585|3121434|Superiority or Other||Days until LTR at the 25th percentile|30.0||||||95.0|||||||||
1698375|NCT01014585|3121434|Superiority or Other||Days until LTR at the 25th percentile|18.0||||||95.0|||||||||
1698376|NCT01014585|3121434|Superiority or Other||Hazard Ratio (HR)|0.8||||0.4104|2-Sided|95.0|0.46|1.38|||Log Rank||||
1698377|NCT01014585|3121435|Superiority or Other||Days until LTR at the 25th percentile|22.0||||||95.0|||||||||
1698378|NCT01014585|3121435|Superiority or Other||Hazard Ratio (HR)|0.36||||0.0002|2-Sided|95.0|0.2|0.63|||Log Rank||||
1698379|NCT01014585|3121436|Superiority or Other||Days until LTR at the 25th percentile|45.0||||||95.0|||||||||
1698380|NCT01014585|3121436|Superiority or Other||Days until LTR at the 25th percentile|18.0||||||95.0|||||||||
1698381|NCT01014585|3121436|Superiority or Other||Hazard Ratio (HR)|0.44||||0.0004|2-Sided|95.0|0.27|0.71|||Log Rank||||
1698382|NCT01014455|3121440|Superiority or Other|||||||0.672|||||||t-test, 2 sided||||
1698383|NCT01014442|3121442|Superiority or Other||Difference in rates|-1.8||||1|2-Sided|95.0|-24.9|22.1|||Fisher Exact||||
1698384|NCT01014442|3121448|Superiority or Other||Hodges-Lehmann estimator|-0.0857||||0.2178|2-Sided|95.0|-0.187|0.0265|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698385|NCT01014442|3121449|Superiority or Other||Hodges-Lehmann estimator|0.001||||0.9873|2-Sided|95.0|-0.1152|0.1173|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698386|NCT01014442|3121450|Superiority or Other||Hodges-Lehmann estimator|0.0427||||0.3628|2-Sided|95.0|-0.0455|0.1221|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698387|NCT01014442|3121451|Superiority or Other||Hodges-Lehmann estimator|0.1616||||0.0821|2-Sided|95.0|-0.0121|0.4188|||Wilcoxon rank sum test|||Free Fraction of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698388|NCT01014442|3121452|Superiority or Other||Hodge-Lehmann estimator|-0.0000239||||0.1927|2-Sided|95.0|-0.0000594|0.0000154|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698389|NCT01014442|3121452|Superiority or Other||Hodges-Lehmann estimator|0.00033||||0.817|2-Sided|95.0|-0.00361|0.00421|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698390|NCT01014442|3121452|Superiority or Other||Hodges-Lehmann estimator|-0.1461||||0.2941|2-Sided|95.0|-0.39951|0.12988|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698391|NCT01014442|3121452|Superiority or Other||Hodges-Lehmann estimator|0.00054||||0.9417|2-Sided|95.0|-0.01037|0.01042|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698392|NCT01014442|3121453|Superiority or Other||Hodges-Lehmann estimator|-0.0000138||||0.1661|2-Sided|95.0|-0.0000295|0.0000047|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698393|NCT01014442|3121453|Superiority or Other||Hodges-Lehmann estimator|-0.0035||||0.0002|2-Sided|95.0|-0.00476|0.00168|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698394|NCT01014442|3121453|Superiority or Other||Hodges-Lehmann estimator|-0.14764||||0.0277|2-Sided|95.0|-0.31026|-0.01067|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698395|NCT01014442|3121453|Superiority or Other||Hodges-Lehmann estimator|-0.0049||||0.0048|2-Sided|95.0|-0.00876|-0.00148|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698396|NCT01014442|3121454|Superiority or Other||Hodges-Lehmann estimator|-0.00001||||0.1769|2-Sided|95.0|-0.000025|0.0000043|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698397|NCT01014442|3121454|Superiority or Other||Hodges-Lehmann estimator|-0.00131||||0.0845|2-Sided|95.0|-0.00352|0.00013|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698398|NCT01014442|3121454|Superiority or Other||Hodges-Lehmann estimator|-0.09626||||0.3198|2-Sided|95.0|-0.25269|0.11464|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698399|NCT01014442|3121454|Superiority or Other||Hodges-Lehmann estimator|-0.00383||||0.0572|2-Sided|95.0|-0.00761|0.0001|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698400|NCT01014442|3121455|Superiority or Other||Hodges-Lehmann estimator|0.0000158||||0.3269|2-Sided|95.0|-0.0000134|0.0000552|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698401|NCT01014442|3121455|Superiority or Other||Hodges-Lehmann estimator|-0.00311||||0.0316|2-Sided|95.0|-0.00645|-0.00029|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698402|NCT01014442|3121455|Superiority or Other||Hodges-Lehmann estimator|0.04797||||0.4325|2-Sided|95.0|-0.08467|0.26322|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698403|NCT01014442|3121455|Superiority or Other||Hodges-Lehmann estimator|-0.00237||||0.1362|2-Sided|95.0|-0.00734|0.00106|||Wilcoxon rank sum test|||Dose-Normalized AUC0-12 of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698404|NCT01014442|3121456|Superiority or Other||Hodges-Lehmann estimator|-21.4737||||0.2453|2-Sided|95.0|-64.1567|8.5708|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698405|NCT01014442|3121457|Superiority or Other||Hodges-Lehmann estimator|-22.7878||||0.0672|2-Sided|95.0|-44.8217|3.7573|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698406|NCT01014442|3121458|Superiority or Other||Hodges-Lehmann estimator|-13.5592||||0.1964|2-Sided|95.0|-37.395|5.4825|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698407|NCT01014442|3121459|Superiority or Other||Hodges-Lehmann estimator|24.315||||0.2342|2-Sided|95.0|-16.0292|79.365|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698408|NCT01014442|3121460|Superiority or Other||Hodges-Lehmann estimator|0.888||||0.6251|2-Sided|95.0|-3.0288|4.2273|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698409|NCT01014442|3121460|Superiority or Other||Hodges-Lehmann estimator|-156.3255||||0.3413|2-Sided|95.0|-526.0765|195.8348|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698410|NCT01014442|3121460|Superiority or Other||Hodges-Lehmann estimator|1.7477||||0.7144|2-Sided|95.0|-12.101|14.6563|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698411|NCT01014442|3121461|Superiority or Other||Hodges-Lehmann estimator|-4.828|||<|0.0001|2-Sided|95.0|-7.1455|-2.6133|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698412|NCT01014442|3121461|Superiority or Other||Hodges-Lehmann estimator|-268.9537|||<|0.0058|2-Sided|95.0|-506.7782|-77.397|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698413|NCT01014442|3121461|Superiority or Other||Hodges-Lehmann estimator|-8.6964|||<|0.0002|2-Sided|95.0|-13.7713|-4.6498|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698414|NCT01014442|3121462|Superiority or Other||Hodges-Lehmann estimator|-1.9621||||0.0718|2-Sided|95.0|-4.8456|0.2067|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698415|NCT01014442|3121462|Superiority or Other||Hodges-Lehmann estimator|-171.159||||0.2733|2-Sided|95.0|-361.4437|171.9652|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698416|NCT01014442|3121462|Superiority or Other||Hodges-Lehmann estimator|-5.8077||||0.051|2-Sided|95.0|-11.7302|0.0033|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698523|NCT01014208|3121509|Superiority or Other||Odds Ratio (OR)|0.66||||0.1167|2-Sided|95.0|0.39|1.1||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed CR||
1698526|NCT01014169|3121511|Superiority or Other||Risk Ratio (RR)|1.12||||||95.0|1.0|1.25|||||||
1698417|NCT01014442|3121463|Superiority or Other||Hodges-Lehmann estimator|-3.6042||||0.0441|2-Sided|95.0|-8.1854|-0.1887|||Wilcoxon rank sum test|||AUC0-12 of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698418|NCT01014442|3121463|Superiority or Other||Hodges-Lehmann estimator|72.7203||||0.4063|2-Sided|95.0|-107.1596|393.5295|||Wilcoxon rank sum test|||AUC0-12 of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698419|NCT01014442|3121463|Superiority or Other||Hodges-Lehmann estimator|-2.4102||||0.2798|2-Sided|95.0|-8.5642|3.0044|||Wilcoxon rank sum test|||AUC0-12 of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698420|NCT01014442|3121464|Superiority or Other||Hodges-Lehmann estimator|-4.9076||||0.817|2-Sided|95.0|-84.8234|109.9321|||Wilcoxon rank sum test|||CL of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698421|NCT01014442|3121464|Superiority or Other||Hodges-Lehmann estimator|0.1817||||0.2941|2-Sided|95.0|-0.1954|0.6246|||Wilcoxon rank sum test|||CL of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698422|NCT01014442|3121464|Superiority or Other||Hodges-Lehmann estimator|-0.579||||0.9417|2-Sided|95.0|-14.5052|11.6346|||Wilcoxon rank sum test|||CL of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698423|NCT01014442|3121465|Superiority or Other||Hodges-Lehmann estimator|318.5455||||0.0002|2-Sided|95.0|154.1902|526.1716|||Wilcoxon rank sum test|||CL of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698424|NCT01014442|3121465|Superiority or Other||Hodges-Lehmann estimator|0.4297||||0.0277|2-Sided|95.0|0.034|0.9925|||Wilcoxon rank sum test|||CL of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698425|NCT01014442|3121465|Superiority or Other||Hodges-Lehmann estimator|25.0037||||0.0048|2-Sided|95.0|8.2373|43.5102|||Wilcoxon rank sum test|||CL of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698426|NCT01014442|3121466|Superiority or Other||Hodges-Lehmann estimator|54.0322||||0.0845|2-Sided|95.0|-6.7706|160.3469|||Wilcoxon rank sum test|||CL of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698427|NCT01014442|3121466|Superiority or Other||Hodges-Lehmann estimator|0.3541||||0.3198|2-Sided|95.0|-0.2524|1.1097|||Wilcoxon rank sum test|||CL of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698428|NCT01014442|3121466|Superiority or Other||Hodges-Lehmann estmator|19.0536||||0.0572|2-Sided|95.0|-0.425|35.3852|||Wilcoxon rank sum test|||CL of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698429|NCT01014442|3121467|Superiority or Other||Hodges-Lehmann estimator|47.2686||||0.0316|2-Sided|95.0|4.197|112.7806|||Wilcoxon rank sum test|||CL of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698430|NCT01014442|3121467|Superiority or Other||Hodges-Lehmann estimator|-0.1609||||0.4325|2-Sided|95.0|-0.5693|0.271|||Wilcoxon rank sum test|||CL of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698431|NCT01014442|3121467|Superiority or Other||Hodges-Lehmann estimator|7.8422||||0.1362|2-Sided|95.0|-3.911|18.4444|||Wilcoxon rank sum test|||CL of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698432|NCT01014442|3121468|Superiority or Other||Hodges-Lehmann estimator|-149.7962||||0.3744|2-Sided|95.0|-644.4526|311.9735|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698433|NCT01014442|3121468|Superiority or Other||Hodges-Lehmann estimator|0.0077||||0.9692|2-Sided|95.0|-3.6739|3.9521|||Wilcoxon rank sum test|||Vz of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698524|NCT01014208|3121509|Superiority or Other||Odds Ratio (OR)|0.84||||0.4053|2-Sided|95.0|0.56|1.24||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed OR||
1698527|NCT01014169|3121512|Superiority or Other||Risk Ratio (RR)|1.11|||||2-Sided|95.0|0.99|1.25|||||||
1698434|NCT01014442|3121468|Superiority or Other||Hodges-Lehmann estimator|4.7477||||0.9029|2-Sided|95.0|-73.5212|59.8304|||Wilcoxon rank sum test|||Vz of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698435|NCT01014442|3121469|Superiority or Other||Hodges-Lehmann estimator|635.7812||||0.0306|2-Sided|95.0|49.4696|2793.7642|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698436|NCT01014442|3121469|Superiority or Other||Hodges-Lehmann estimator|2.6186||||0.0689|2-Sided|95.0|-0.1999|6.7766|||Wilcoxon rank sum test|||Vz of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698437|NCT01014442|3121469|Superiority or Other||Hodges-Lehmann estimator|207.9933||||0.004|2-Sided|95.0|71.2442|355.1739|||Wilcoxon rank sum test|||Vz of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698438|NCT01014442|3121470|Superiority or Other||Hodges-Lehmann estimator|121.3737||||0.4072|2-Sided|95.0|-233.6483|560.0069|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698439|NCT01014442|3121470|Superiority or Other||Hodges-Lehmann estimator|-0.4456||||0.7842|2-Sided|95.0|-3.1366|2.292|||Wilcoxon rank sum test|||Vz of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698440|NCT01014442|3121470|Superiority or Other||Hodges-Lehmann estimator|88.959||||0.0659|2-Sided|95.0|-5.7876|209.0183|||Wilcoxon rank sum test|||Vz of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698441|NCT01014442|3121471|Superiority or Other||Hodges-Lehmann estimator|299.1021||||0.0188|2-Sided|95.0|79.5869|695.1789|||Wilcoxon rank sum test|||Vz of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698442|NCT01014442|3121471|Superiority or Other||Hodges-Lehmann estimator|-0.7836||||0.6057|2-Sided|95.0|-3.2675|2.5529|||Wilcoxon rank sum test|||Vz of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698443|NCT01014442|3121471|Superiority or Other||Hodges-Lehmann estimator|69.7186||||0.1552|2-Sided|95.0|-23.4659|162.9545|||Wilcoxon rank sum test|||Vz of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698444|NCT01014442|3121472|Superiority or Other||Hodges-Lehmann estimator|-8.205||||0.0414|2-Sided|95.0|-19.27|-0.07|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698445|NCT01014442|3121473|Superiority or Other||Hodges-Lehmann estimator|-4.935||||0.0819|2-Sided|95.0|-14.31|1.11|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698446|NCT01014442|3121474|Superiority or Other||Hodges-Lehmann estimator|-0.44||||0.893|2-Sided|95.0|-6.07|8.01|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698447|NCT01014442|3121475|Superiority or Other||Hodges-Lehmann estimator|5.22||||0.4043|2-Sided|95.0|-5.01|24.49|||Wilcoxon rank sum test|||Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698448|NCT01014442|3121476|Superiority or Other||Hodges-Lehmann estimator|-0.03||||0.8704|2-Sided|95.0|-0.28|0.23|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698449|NCT01014442|3121476|Superiority or Other||Hodges-Lehmann estimator|-20.3||||0.1243|2-Sided|95.0|-49.39|4.71|||Wilcoxon rank sum test|||Cmin of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698450|NCT01014442|3121476|Superiority or Other||Hodges-Lehmann estimator|-0.36||||0.3289|2-Sided|95.0|-1.14|0.28|||Wilcoxon rank sum test|||Cmin of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698451|NCT01014442|3121477|Superiority or Other||Hodges-Lehmann estimator|-0.19||||0.0081|2-Sided|95.0|-0.41|-0.04|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698452|NCT01014442|3121477|Superiority or Other||Hodges-Lehmann estimator|-14.03||||0.0945|2-Sided|95.0|-26.9|2.94|||Wilcoxon rank sum test|||Cmin of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698453|NCT01014442|3121477|Superiority or Other||Hodges-Lehmann estimator|-0.215||||0.0818|2-Sided|95.0|-0.56|0.05|||Wilcoxon rank sum test|||Cmin of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698454|NCT01014442|3121478|Superiority or Other||Hodges-Lehmann estimator|-0.2||||0.0112|2-Sided|95.0|-0.35|-0.05|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698455|NCT01014442|3121478|Superiority or Other||Hodges-Lehmann estimator|-16.09||||0.0875|2-Sided|95.0|-29.35|6.39|||Wilcoxon rank sum test|||Cmin of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698456|NCT01014442|3121478|Superiority or Other||Hodges-Lehmann estimator|-0.125||||0.4027|2-Sided|95.0|-0.38|0.19|||Wilcoxon rank sum test|||Cmin of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698457|NCT01014442|3121479|Superiority or Other||Hodges-Lehmann estimator|-0.165||||0.1794|2-Sided|95.0|-0.45|0.08|||Wilcoxon rank sum test|||Cmin of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698458|NCT01014442|3121479|Superiority or Other||Hodges-Lehmann estimator|11.16||||0.2088|2-Sided|95.0|-5.29|30.29|||Wilcoxon rank sum test|||Cmin of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698459|NCT01014442|3121479|Superiority or Other||Hodges-Lehmann estimator|0.13||||0.5224|2-Sided|95.0|-0.26|0.5|||Wilcoxon rank sum test|||Cmin of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698460|NCT01014442|3121480|Superiority or Other||Hodges-Lehmann estimator|-0.15||||0.0082|2-Sided|95.0|-0.2333|-0.0667|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698461|NCT01014442|3121480|Superiority or Other||Hodges-Lehmann estimator|-0.525||||0.0558|2-Sided|95.0|-2.6167|0.0|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698462|NCT01014442|3121480|Superiority or Other||Hodges-Lehmann estimator|-1.8333||||0.0386|2-Sided|95.0|-2.2|0.0|||Wilcoxon rank sum test|||Tmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698463|NCT01014442|3121480|Superiority or Other||Hodges-Lehmann estimator|-0.0333||||0.8834|2-Sided|95.0|-1.1667|0.7|||Wilcoxon rank sum test|||Tmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698464|NCT01014442|3121481|Superiority or Other||Hodges-Lehmann estimator|0.0||||0.972|2-Sided|95.0|-0.05|0.0333|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698465|NCT01014442|3121481|Superiority or Other||Hodges-Lehmann estimator|-0.1667||||0.4425|2-Sided|95.0|-1.9667|0.2|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698466|NCT01014442|3121481|Superiority or Other||Hodges-Lehmann estimator|-0.0833||||0.4947|2-Sided|95.0|-2.0|0.0833|||Wilcoxon rank sum test|||Tmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698467|NCT01014442|3121481|Superiority or Other||Hodges-Lehmann estimator|0.0||||1|2-Sided|95.0|-1.1667|0.5833|||Wilcoxon rank sum test|||Tmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698468|NCT01014442|3121482|Superiority or Other||Hodges-Lehmann estimator|0.0||||0.433|2-Sided|95.0|-0.1667|0.0167|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698469|NCT01014442|3121482|Superiority or Other||Hodges-Lehmann estimator|0.0667||||0.6311|2-Sided|95.0|-0.3333|1.4667|||Wilcoxon rank sum test|||Tmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698470|NCT01014442|3121482|Superiority or Other||Hodges-Lehmann estimator|0.0||||1|2-Sided|95.0|-0.1667|0.1667|||Wilcoxon rank sum test|||Tmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698471|NCT01014442|3121482|Superiority or Other||Hodges-Lehmann estimator|0.0417||||0.8106|2-Sided|95.0|-0.5|1.7333|||Wilcoxon rank sum test|||Tmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698472|NCT01014442|3121483|Superiority or Other||Hodges-Lehmann estimator|0.0||||0.0823|2-Sided|95.0|0.0|0.0667|||Wilcoxon rank sum test|||Tmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698473|NCT01014442|3121483|Superiority or Other||Hodges-Lehmann estimator|-0.5||||0.0929|2-Sided|95.0|-2.0833|0.0|||Wilcoxon rank sum test|||Tmax of AcMPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698474|NCT01014442|3121483|Superiority or Other||Hodges-Lehmann estimator|-1.8||||0.2003|2-Sided|95.0|-2.3333|0.0833|||Wilcoxon rank sum test|||Tmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698475|NCT01014442|3121483|Superiority or Other||Hodges-Lehmann estimator|-0.0333||||0.5745|2-Sided|95.0|-1.95|0.5|||Wilcoxon rank sum test|||Tmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698476|NCT01014442|3121484|Superiority or Other||Hodges-Lehmann estimator|-0.00001||||0.6472|2-Sided|95.0|-0.0000586|0.0000364|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698477|NCT01014442|3121484|Superiority or Other||Hodges-Lehmann estimator|0.00023||||0.4345|2-Sided|95.0|-0.0003|0.0007|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698478|NCT01014442|3121484|Superiority or Other||Hodges-Lehmann estimator|-0.00567||||0.8262|2-Sided|95.0|-0.03414|0.02671|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698479|NCT01014442|3121484|Superiority or Other||Hodges-Lehmann estimator|0.0043||||0.0509|2-Sided|95.0|-0.00027|0.00833|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698480|NCT01014442|3121485|Superiority or Other||Hodges-Lehmann estimator|-0.0000126||||0.176|2-Sided|95.0|-0.0000328|-0.0000091|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698481|NCT01014442|3121485|Superiority or Other||Hodges-Lehmann estimator|-0.00037||||0.0032|2-Sided|95.0|-0.00062|-0.00015|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698482|NCT01014442|3121485|Superiority or Other||Hodges-Lehmann estimator|-0.01602||||0.0942|2-Sided|95.0|-0.03229|0.00297|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698483|NCT01014442|3121485|Superiority or Other||Hodges-Lehmann estimator|-0.00063||||0.3784|2-Sided|95.0|-0.0023|0.00084|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698484|NCT01014442|3121486|Superiority or Other||Hodges-Lehmann estimator|-0.0000185||||0.0173|2-Sided|95.0|-0.0000394|-0.000005|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698485|NCT01014442|3121486|Superiority or Other||Hodges-Lehmann estimator|-0.00017||||0.2677|2-Sided|95.0|-0.00046|0.00013|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698486|NCT01014442|3121486|Superiority or Other||Hodges-Lehmann estimator|-0.00695||||0.4131|2-Sided|95.0|-0.0205|0.01103|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698528|NCT01014169|3121513|Superiority or Other||Risk Ratio (RR)|1.13|||||2-Sided|95.0|0.95|1.34|||||||
1698988|NCT01009086|3122245|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1698487|NCT01014442|3121486|Superiority or Other||Hodges-Lehmann estimator|-0.00081||||0.1511|2-Sided|95.0|-0.00216|0.0003|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698488|NCT01014442|3121487|Superiority or Other||Hodges-Lehmann estimator|0.0000112||||0.4334|2-Sided|95.0|-0.000014|0.0000462|||Wilcoxon rank sum test|||Dose-Normalized Cmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called a Hodges-Lehmann estimator.|
1698489|NCT01014442|3121487|Superiority or Other||Hodges-Lehmann estimator|-0.00026||||0.2108|2-Sided|95.0|-0.0007|0.00012|||Wilcoxon rank sum test|||Dose-Normalized Cmax of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698490|NCT01014442|3121487|Superiority or Other||Hodges-Lehmann estimator|0.00728||||0.3223|2-Sided|95.0|-0.00707|0.03161|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698491|NCT01014442|3121487|Superiority or Other||Hodges-Lehmann estimator|0.0005||||0.5466|2-Sided|95.0|-0.00103|0.00259|||Wilcoxon rank sum test|||Dose-Normalized Cmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698492|NCT01014442|3121488|Superiority or Other||Hodges-Lehmann estimator|-15.63||||0.5974|2-Sided|95.0|-63.88|30.56|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698493|NCT01014442|3121489|Superiority or Other||Hodges-Lehmann estimator|-23.805||||0.1151|2-Sided|95.0|-52.27|5.97|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698494|NCT01014442|3121490|Superiority or Other||Hodges-Lehmann estimator|-25.24||||0.0334|2-Sided|95.0|-53.25|-2.29|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698495|NCT01014442|3121491|Superiority or Other||Hodges-Lehmann estimator|17.08||||0.3002|2-Sided|95.0|-16.5|74.32|||Wilcoxon rank sum test|||Cmax of Free MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698496|NCT01014442|3121492|Superiority or Other||Hodges-Lehmann estimator|0.27||||0.393|2-Sided|95.0|-0.31|0.88|||Wilcoxon rank sum test|||Cmax of AcMPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698497|NCT01014442|3121492|Superiority or Other||Hodges-Lehmann estimator|-7.59||||0.7144|2-Sided|95.0|-51.19|30.7|||Wilcoxon rank sum test|||Cmax of MPAG at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698498|NCT01014442|3121492|Superiority or Other||Hodges-Lehmann estimator|3.945||||0.0318|2-Sided|95.0|0.25|8.23|||Wilcoxon rank sum test|||Cmax of MPA at Day 90. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698499|NCT01014442|3121493|Superiority or Other||Hodges-Lehmann estimator|-0.56||||0.0008|2-Sided|95.0|-1.02|-0.27|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698500|NCT01014442|3121493|Superiority or Other||Hodges-Lehmann estimator|-30.76||||0.022|2-Sided|95.0|-54.97|-6.36|||Wilcoxon rank sum test|||Cmax of MPAG at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698501|NCT01014442|3121493|Superiority or Other||Hodges-Lehmann estimator|-1.87||||0.0886|2-Sided|95.0|-3.79|0.28|||Wilcoxon rank sum test|||Cmax of MPA at Day 20. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698502|NCT01014442|3121494|Superiority or Other||Hodges-Lehmann estimator|-0.2||||0.2218|2-Sided|95.0|-0.6|0.19|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698503|NCT01014442|3121494|Superiority or Other||Hodges-Lehmann estimator|-10.845||||0.4886|2-Sided|95.0|-31.5|20.79|||Wilcoxon rank sum test|||Cmax of MPAG at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698525|NCT01014208|3121510|Superiority or Other||Hazard Ratio (HR)|1.12||||0.333|2-Sided|95.0|0.89|1.42||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-rank test||The Pike estimator was the statistical method used to estimate the hazard ratio.||
1698504|NCT01014442|3121494|Superiority or Other||Hodges-Lehmann estimator|-1.29||||0.1308|2-Sided|95.0|-2.99|0.41|||Wilcoxon rank sum test|||Cmax of MPA at Day 8. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698505|NCT01014442|3121495|Superiority or Other||Hodges-Lehmann estimator|-0.305||||0.2953|2-Sided|95.0|-0.81|0.19|||Wilcoxon rank sum test|||Cmax of AcMPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698506|NCT01014442|3121495|Superiority or Other||Hodges-Lehmann estimator|11.405||||0.3113|2-Sided|95.0|-10.2|42.78|||Wilcoxon rank sum test|||Cmax of MPAG at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698507|NCT01014442|3121495|Superiority or Other||Hodges-Lehmann estimator|1.305||||0.2649|2-Sided|95.0|-0.83|4.25|||Wilcoxon rank sum test|||Cmax of MPA at Day 4. Analysis was performed using Wilcoxon rank sum test; corresponding p-value and point estimate (Hodges-Lehmann estimator) were calculated. The point estimator derived by sending the confidence level to zero is called as Hodges-Lehmann estimator.|
1698508|NCT01014208|3121500|Superiority or Other||Hazard Ratio (HR)|0.6||||0.035|2-Sided|95.0|0.36|1.0||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio <1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||
1698509|NCT01014208|3121501|Superiority or Other||Hazard Ratio (HR)|1.21||||0.102|2-Sided|95.0|0.93|1.59||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 3. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio <1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|
1698510|NCT01014208|3121501|Superiority or Other||Hazard Ratio (HR)|0.88||||0.199|2-Sided|95.0|0.7|1.1||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 2. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio <1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|
1698511|NCT01014208|3121501|Superiority or Other||Hazard Ratio (HR)|1.05||||0.597|2-Sided|95.0|0.86|1.29||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Platelets, Cycle 1. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio <1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|
1698512|NCT01014208|3121501|Superiority or Other||Hazard Ratio (HR)|1.11||||0.451|2-Sided|95.0|0.83|1.48||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 3. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio <1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|
1698513|NCT01014208|3121501|Superiority or Other||Hazard Ratio (HR)|0.81||||0.059|2-Sided|95.0|0.64|1.02||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 2. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio <1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|
1698514|NCT01014208|3121501|Superiority or Other||Hazard Ratio (HR)|0.93||||0.479|2-Sided|95.0|0.74|1.16||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified Log-Rank|||Statistics are presented for Category-Neutrophils, Cycle 1. Confidence Interval (CI) estimated using the Brookmeyer-Crowley method. HR are estimated using the Pike estimator. A hazard ratio <1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.|
1698515|NCT01014208|3121502|Superiority or Other||Mean Difference (Final Values)|1.129||||0.387|2-Sided|95.0|-1.434|3.691|||ANCOVA||||
1698516|NCT01014208|3121503|Superiority or Other||Mean Difference (Final Values)|0.03||||0.978|2-Sided|95.0|-2.11|2.17|||ANCOVA||||
1698517|NCT01014208|3121504|Superiority or Other||Odds Ratio (OR)|0.84||||0.4481|2-Sided|95.0|0.56|1.27||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||Statistics are presented for Completion rate||
1698518|NCT01014208|3121505|Superiority or Other||Odds Ratio (OR)|2.57||||0.1161|2-Sided|95.0|0.83|9.5||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||||
1698519|NCT01014208|3121506|Superiority or Other||Hazard Ratio (HR)|0.9||||0.377|2-Sided|95.0|0.7|1.15||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified log-rank test||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio <1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||
1698520|NCT01014208|3121507|Superiority or Other||Hazard Ratio (HR)|1.1||||0.346|2-Sided|95.0|0.9|1.36||p-value from stratified log-rank test are adjusted for stratification factors.|Stratified log-rank test||Confidence Interval estimated using the Brookmeyer-Crowley method. HR are estimated using Pike estimator. A hazard ratio <1 indicates a lower probability of recovery with Ofatumumab compared to Rituximab. HR was adjusted for stratification factors.||
1698521|NCT01014208|3121508|Superiority or Other||Odds Ratio (OR)|1.23||||0.6313|2-Sided|95.0|0.62|2.43||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed CR||
1698522|NCT01014208|3121508|Superiority or Other||Odds Ratio (OR)|1.15||||0.8209|2-Sided|95.0|0.55|2.43||p-value for the test of Odds Ratio being 1.|Cochran-Mantel-Haenszel||For Category title- Independent reviewer-assessed OR||
1698529|NCT01014143|3121514|Superiority or Other|||||||0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1698530|NCT01014013|3121532|Non-Inferiority or Equivalence|The secondary efficacy endpoint was based on the proportion of patients who had a favorable clinical response assessment at follow-up 5 to 9 days post-therapy visit. The definition of non-inferiority is that the 95%(two-sided) confidence interval for the difference in response rate between the 2 treatment groups(MK0826 minus control group) contains zero and the lower limit of the CI is not less than -20 percentage points.|the difference between two response rate|-1.7|Standard Error of the Mean|4.9||||95.0|-6.6|3.2|||||||
1698531|NCT01014013|3121534|Non-Inferiority or Equivalence|The primary efficacy endpoint was based on the proportion of patients who had a favorable microbiological response assessment at follow-up 5 to 9 days post-therapy visit. The definition of non-inferiority is that the 95%(two-sided) confidence interval for the difference in response rate between the 2 treatment groups(MK0826 minus control group) contains zero and the lower limit of the CI is not less than -20 percentage points.|the difference between two response rate|-0.8|Standard Deviation|10.9||||95.0|-11.7|10.2|||||||
1698532|NCT01013961|3121539|Superiority or Other|||||||1|||||||Fisher Exact||||
1698533|NCT01013961|3121540|Superiority or Other|||||||0.722|||||||Fisher Exact||||
1698534|NCT01013753|3121558|Superiority or Other||Ratio of geometric means|0.994||||0.4803||95.0|0.979|1.01|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698535|NCT01013753|3121558|Superiority or Other||Ratio of geometric means|0.991||||0.2552||95.0|0.975|1.007|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698536|NCT01013753|3121558|Superiority or Other||Ratio of geometric means|0.987||||0.1029||95.0|0.973|1.003|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698537|NCT01013753|3121558|Superiority or Other||Ratio of geometric means|0.992||||0.2955||95.0|0.977|1.007|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698538|NCT01013753|3121558|Superiority or Other||Ratio of geometric means|0.999||||0.9112||95.0|0.984|1.015|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698539|NCT01013753|3121559|Superiority or Other||Ratio of geometric means|0.991||||0.3085||95.0|0.973|1.009|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698540|NCT01013753|3121559|Superiority or Other||Ratio of geometric means|0.98||||0.0283||95.0|0.962|0.998|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698541|NCT01013753|3121559|Superiority or Other||Ratio of geometric means|0.977||||0.0109||95.0|0.96|0.995|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698542|NCT01013753|3121559|Superiority or Other||Ratio of geometric means|0.979||||0.0218||95.0|0.962|0.997|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698543|NCT01013753|3121559|Superiority or Other||Ratio of geometric means|0.993||||0.4423||95.0|0.975|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698544|NCT01013753|3121560|Superiority or Other||Ratio of geometric means|1.003||||0.6757||95.0|0.988|1.018|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698545|NCT01013753|3121560|Superiority or Other||Ratio of geometric means|0.998||||0.7664||95.0|0.983|1.013|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698546|NCT01013753|3121560|Superiority or Other||Ratio of geometric means|0.999||||0.8641||95.0|0.984|1.014|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698547|NCT01013753|3121560|Superiority or Other||Ratio of geometric means|0.996||||0.6022||95.0|0.981|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698548|NCT01013753|3121560|Superiority or Other||Ratio of geometric means|0.996||||0.6187||95.0|0.981|1.011|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698549|NCT01013753|3121561|Superiority or Other||Mean Difference (Final Values)|-0.346|Standard Error of the Mean|0.056|<|0.0001||95.0|-0.457|-0.235|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698550|NCT01013753|3121561|Superiority or Other||Mean Difference (Final Values)|-0.394|Standard Error of the Mean|0.057|<|0.0001||95.0|-0.505|-0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698551|NCT01013753|3121561|Superiority or Other||Mean Difference (Final Values)|-0.326|Standard Error of the Mean|0.056|<|0.0001||95.0|-0.436|-0.215|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698552|NCT01013753|3121561|Superiority or Other||Mean Difference (Final Values)|-0.293|Standard Error of the Mean|0.056|<|0.0001||95.0|-0.403|-0.184|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698703|NCT01012245|3121715|Superiority or Other||Mean value|0.39|Standard Deviation|0.19||||95.0|0.35|0.43||||||Vertical C/D ratio 1 year (n=88)|
1698553|NCT01013753|3121561|Superiority or Other||Mean Difference (Final Values)|-0.321|Standard Error of the Mean|0.057|<|0.0001||95.0|-0.432|-0.21|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698554|NCT01013753|3121562|Superiority or Other||Mean Difference (Final Values)|0.315|Standard Error of the Mean|0.057|<|0.0001||95.0|0.203|0.426|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698555|NCT01013753|3121562|Superiority or Other||Mean Difference (Final Values)|0.317|Standard Error of the Mean|0.057|<|0.0001||95.0|0.205|0.429|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698556|NCT01013753|3121562|Superiority or Other||Mean Difference (Final Values)|0.262|Standard Error of the Mean|0.057|<|0.0001||95.0|0.151|0.374|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698557|NCT01013753|3121562|Superiority or Other||Mean Difference (Final Values)|0.209|Standard Error of the Mean|0.056|<|0.0002||95.0|0.099|0.318|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698558|NCT01013753|3121562|Superiority or Other||Mean Difference (Final Values)|0.289|Standard Error of the Mean|0.057|<|0.0001||95.0|0.178|0.4|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698559|NCT01013753|3121567|Superiority or Other||Mean Difference (Final Values)|-0.449|Standard Error of the Mean|0.123||0.0003||95.0|-0.691|-0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698560|NCT01013753|3121567|Superiority or Other||Mean Difference (Final Values)|-0.657|Standard Error of the Mean|0.124|<|0.0001||95.0|-0.901|-0.413|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698561|NCT01013753|3121567|Superiority or Other||Mean Difference (Final Values)|-0.478|Standard Error of the Mean|0.123|<|0.0001||95.0|-0.72|-0.237|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698562|NCT01013753|3121567|Superiority or Other||Mean Difference (Final Values)|-0.432|Standard Error of the Mean|0.122|<|0.0004||95.0|-0.671|-0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698563|NCT01013753|3121567|Superiority or Other||Mean Difference (Final Values)|-0.526|Standard Error of the Mean|0.124|<|0.0001||95.0|-0.77|-0.282|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698564|NCT01013753|3121568|Superiority or Other||Mean Difference (Final Values)|0.079|Standard Error of the Mean|0.024||0.001||95.0|0.032|0.125|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698565|NCT01013753|3121568|Superiority or Other||Mean Difference (Final Values)|0.117|Standard Error of the Mean|0.024|<|0.0001||95.0|0.07|0.164|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698566|NCT01013753|3121568|Superiority or Other||Mean Difference (Final Values)|0.088|Standard Error of the Mean|0.024|<|0.0002||95.0|0.042|0.135|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698567|NCT01013753|3121568|Superiority or Other||Mean Difference (Final Values)|0.081|Standard Error of the Mean|0.023|<|0.0006||95.0|0.035|0.127|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698568|NCT01013753|3121568|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.024|<|0.0362||95.0|0.003|0.097|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698569|NCT01013753|3121569|Superiority or Other||Mean Difference (Final Values)|0.093|Standard Error of the Mean|0.024||0.0001||95.0|0.045|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698570|NCT01013753|3121569|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.025|<|0.0001||95.0|0.121|0.217|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698571|NCT01013753|3121569|Superiority or Other||Mean Difference (Final Values)|0.135|Standard Error of the Mean|0.024|<|0.0001||95.0|0.087|0.183|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698572|NCT01013753|3121569|Superiority or Other||Mean Difference (Final Values)|0.128|Standard Error of the Mean|0.024|<|0.0001||95.0|0.081|0.176|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698573|NCT01013753|3121569|Superiority or Other||Mean Difference (Final Values)|0.093|Standard Error of the Mean|0.025|<|0.0002||95.0|0.045|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698574|NCT01013753|3121570|Superiority or Other||Mean Difference (Final Values)|-1.27|Standard Error of the Mean|0.503||0.0118||95.0|-2.258|-0.283|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698575|NCT01013753|3121570|Superiority or Other||Mean Difference (Final Values)|-1.789|Standard Error of the Mean|0.506||0.0004||95.0|-2.783|-0.795|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698576|NCT01013753|3121570|Superiority or Other||Mean Difference (Final Values)|-1.836|Standard Error of the Mean|0.503||0.0003||95.0|-2.824|-0.849|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698577|NCT01013753|3121570|Superiority or Other||Mean Difference (Final Values)|-2.095|Standard Error of the Mean|0.498|<|0.0001||95.0|-3.073|-1.116|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698578|NCT01013753|3121570|Superiority or Other||Mean Difference (Final Values)|-1.994|Standard Error of the Mean|0.507|<|0.0001||95.0|-2.989|-0.999|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698579|NCT01013753|3121571|Superiority or Other||Mean Difference (Final Values)|20.439|Standard Error of the Mean|3.614|<|0.0001||95.0|13.341|27.538|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698580|NCT01013753|3121571|Superiority or Other||Mean Difference (Final Values)|28.449|Standard Error of the Mean|3.637|<|0.0001||95.0|21.305|35.594|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698581|NCT01013753|3121571|Superiority or Other||Mean Difference (Final Values)|23.613|Standard Error of the Mean|3.601|<|0.0001||95.0|16.539|30.686|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698582|NCT01013753|3121571|Superiority or Other||Mean Difference (Final Values)|24.834|Standard Error of the Mean|3.58|<|0.0001||95.0|17.801|31.866|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698583|NCT01013753|3121571|Superiority or Other||Mean Difference (Final Values)|14.92|Standard Error of the Mean|3.64|<|0.0001||95.0|7.77|22.071|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698584|NCT01013753|3121572|Superiority or Other||Mean Difference (Final Values)|23.528|Standard Error of the Mean|3.644|<|0.0001||95.0|16.371|30.686|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698585|NCT01013753|3121572|Superiority or Other||Mean Difference (Final Values)|32.935|Standard Error of the Mean|3.668|<|0.0001||95.0|25.73|40.139|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698586|NCT01013753|3121572|Superiority or Other||Mean Difference (Final Values)|27.887|Standard Error of the Mean|3.631|<|0.0001||95.0|20.755|35.019|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698587|NCT01013753|3121572|Superiority or Other||Mean Difference (Final Values)|29.022|Standard Error of the Mean|3.61|<|0.0001||95.0|21.931|36.114|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698588|NCT01013753|3121572|Superiority or Other||Mean Difference (Final Values)|22.012|Standard Error of the Mean|3.671|<|0.0001||95.0|14.802|29.223|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698589|NCT01013753|3121573|Superiority or Other||Mean Difference (Final Values)|0.447|Standard Error of the Mean|0.069|<|0.0001||95.0|0.311|0.583|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698590|NCT01013753|3121573|Superiority or Other||Mean Difference (Final Values)|0.624|Standard Error of the Mean|0.07|<|0.0001||95.0|0.487|0.761|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698591|NCT01013753|3121573|Superiority or Other||Mean Difference (Final Values)|0.484|Standard Error of the Mean|0.069|<|0.0001||95.0|0.348|0.62|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698592|NCT01013753|3121573|Superiority or Other||Mean Difference (Final Values)|0.468|Standard Error of the Mean|0.069|<|0.0001||95.0|0.333|0.602|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698593|NCT01013753|3121573|Superiority or Other||Mean Difference (Final Values)|0.264|Standard Error of the Mean|0.07|<|0.0002||95.0|0.127|0.401|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698594|NCT01013753|3121574|Superiority or Other||Mean Difference (Final Values)|0.504|Standard Error of the Mean|0.068|<|0.0001||95.0|0.371|0.637|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698595|NCT01013753|3121574|Superiority or Other||Mean Difference (Final Values)|0.534|Standard Error of the Mean|0.068|<|0.0001||95.0|0.4|0.669|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698596|NCT01013753|3121574|Superiority or Other||Mean Difference (Final Values)|0.466|Standard Error of the Mean|0.068|<|0.0001||95.0|0.333|0.599|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698597|NCT01013753|3121574|Superiority or Other||Mean Difference (Final Values)|0.429|Standard Error of the Mean|0.067|<|0.0001||95.0|0.297|0.561|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698598|NCT01013753|3121574|Superiority or Other||Mean Difference (Final Values)|0.302|Standard Error of the Mean|0.068|<|0.0001||95.0|0.168|0.436|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698599|NCT01013753|3121575|Superiority or Other||Mean Difference (Final Values)|0.57|Standard Error of the Mean|0.061|<|0.0001||95.0|0.451|0.689|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698600|NCT01013753|3121575|Superiority or Other||Mean Difference (Final Values)|0.66|Standard Error of the Mean|0.061|<|0.0001||95.0|0.54|0.781|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698601|NCT01013753|3121575|Superiority or Other||Mean Difference (Final Values)|0.572|Standard Error of the Mean|0.061|<|0.0001||95.0|0.453|0.692|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698602|NCT01013753|3121575|Superiority or Other||Mean Difference (Final Values)|0.527|Standard Error of the Mean|0.06|<|0.0001||95.0|0.409|0.645|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698603|NCT01013753|3121575|Superiority or Other||Mean Difference (Final Values)|0.373|Standard Error of the Mean|0.061|<|0.0001||95.0|0.253|0.493|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698604|NCT01013753|3121576|Superiority or Other||Mean Difference (Final Values)|0.551|Standard Error of the Mean|0.063|<|0.0001||95.0|0.428|0.674|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698605|NCT01013753|3121576|Superiority or Other||Mean Difference (Final Values)|0.648|Standard Error of the Mean|0.063|<|0.0001||95.0|0.524|0.772|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698606|NCT01013753|3121576|Superiority or Other||Mean Difference (Final Values)|0.531|Standard Error of the Mean|0.063|<|0.0001||95.0|0.408|0.655|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698607|NCT01013753|3121576|Superiority or Other||Mean Difference (Final Values)|0.485|Standard Error of the Mean|0.062|<|0.0001||95.0|0.363|0.606|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698608|NCT01013753|3121576|Superiority or Other||Mean Difference (Final Values)|0.337|Standard Error of the Mean|0.063|<|0.0001||95.0|0.213|0.461|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698609|NCT01013753|3121577|Superiority or Other||Mean Difference (Final Values)|0.588|Standard Error of the Mean|0.066|<|0.0001||95.0|0.457|0.718|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698610|NCT01013753|3121577|Superiority or Other||Mean Difference (Final Values)|0.67|Standard Error of the Mean|0.067|<|0.0001||95.0|0.539|0.801|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698611|NCT01013753|3121577|Superiority or Other||Mean Difference (Final Values)|0.612|Standard Error of the Mean|0.066|<|0.0001||95.0|0.482|0.743|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698612|NCT01013753|3121577|Superiority or Other||Mean Difference (Final Values)|0.566|Standard Error of the Mean|0.066|<|0.0001||95.0|0.438|0.695|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698613|NCT01013753|3121577|Superiority or Other||Mean Difference (Final Values)|0.408|Standard Error of the Mean|0.067|<|0.0001||95.0|0.277|0.539|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698614|NCT01013753|3121578|Superiority or Other||Mean Difference (Final Values)|0.051|Standard Error of the Mean|0.025||0.0448||95.0|0.001|0.101|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698615|NCT01013753|3121578|Superiority or Other||Mean Difference (Final Values)|0.129|Standard Error of the Mean|0.026|<|0.0001||95.0|0.078|0.179|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698616|NCT01013753|3121578|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.025|<|0.0001||95.0|0.06|0.16|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698617|NCT01013753|3121578|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.025|<|0.0003||95.0|0.042|0.141|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698618|NCT01013753|3121578|Superiority or Other||Mean Difference (Final Values)|0.037|Standard Error of the Mean|0.026|<|0.147||95.0|-0.013|0.088|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698619|NCT01013753|3121579|Superiority or Other||Mean Difference (Final Values)|0.073|Standard Error of the Mean|0.028||0.0096||95.0|0.018|0.129|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698620|NCT01013753|3121579|Superiority or Other||Mean Difference (Final Values)|0.127|Standard Error of the Mean|0.028|<|0.0001||95.0|0.071|0.183|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698621|NCT01013753|3121579|Superiority or Other||Mean Difference (Final Values)|0.089|Standard Error of the Mean|0.028|<|0.0016||95.0|0.034|0.145|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698989|NCT01009086|3122245|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1698622|NCT01013753|3121579|Superiority or Other||Mean Difference (Final Values)|0.103|Standard Error of the Mean|0.028|<|0.0003||95.0|0.048|0.158|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698623|NCT01013753|3121579|Superiority or Other||Mean Difference (Final Values)|0.048|Standard Error of the Mean|0.028|<|0.0952||95.0|-0.008|0.103|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698624|NCT01013753|3121580|Superiority or Other||Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.023|<|0.0001||95.0|0.051|0.143|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698625|NCT01013753|3121580|Superiority or Other||Mean Difference (Final Values)|0.157|Standard Error of the Mean|0.023|<|0.0001||95.0|0.111|0.203|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698626|NCT01013753|3121580|Superiority or Other||Mean Difference (Final Values)|0.128|Standard Error of the Mean|0.023|<|0.0001||95.0|0.083|0.174|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698627|NCT01013753|3121580|Superiority or Other||Mean Difference (Final Values)|0.136|Standard Error of the Mean|0.023|<|0.0001||95.0|0.09|0.181|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698628|NCT01013753|3121580|Superiority or Other||Mean Difference (Final Values)|0.082|Standard Error of the Mean|0.023|<|0.0005||95.0|0.036|0.128|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698629|NCT01013753|3121581|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.024||0.0001||95.0|0.044|0.137|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698630|NCT01013753|3121581|Superiority or Other||Mean Difference (Final Values)|0.144|Standard Error of the Mean|0.024|<|0.0001||95.0|0.098|0.191|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698631|NCT01013753|3121581|Superiority or Other||Mean Difference (Final Values)|0.115|Standard Error of the Mean|0.024|<|0.0001||95.0|0.069|0.161|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698632|NCT01013753|3121581|Superiority or Other||Mean Difference (Final Values)|0.115|Standard Error of the Mean|0.023|<|0.0001||95.0|0.069|0.16|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698633|NCT01013753|3121581|Superiority or Other||Mean Difference (Final Values)|0.061|Standard Error of the Mean|0.024|<|0.0107||95.0|0.014|0.107|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698634|NCT01013753|3121582|Superiority or Other||Mean Difference (Final Values)|0.102|Standard Error of the Mean|0.026|<|0.0001||95.0|0.051|0.153|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698635|NCT01013753|3121582|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.026|<|0.0001||95.0|0.118|0.221|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698636|NCT01013753|3121582|Superiority or Other||Mean Difference (Final Values)|0.141|Standard Error of the Mean|0.026|<|0.0001||95.0|0.091|0.192|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698637|NCT01013753|3121582|Superiority or Other||Mean Difference (Final Values)|0.156|Standard Error of the Mean|0.026|<|0.0001||95.0|0.106|0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698638|NCT01013753|3121582|Superiority or Other||Mean Difference (Final Values)|0.103|Standard Error of the Mean|0.026|<|0.0001||95.0|0.052|0.154|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698639|NCT01013753|3121583|Superiority or Other||Mean Difference (Final Values)|0.103|Standard Error of the Mean|0.023|<|0.0001||95.0|0.058|0.147|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698640|NCT01013753|3121583|Superiority or Other||Mean Difference (Final Values)|0.199|Standard Error of the Mean|0.023|<|0.0001||95.0|0.153|0.244|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698641|NCT01013753|3121583|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.023|<|0.0001||95.0|0.124|0.214|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698642|NCT01013753|3121583|Superiority or Other||Mean Difference (Final Values)|0.133|Standard Error of the Mean|0.023|<|0.0001||95.0|0.088|0.177|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698643|NCT01013753|3121583|Superiority or Other||Mean Difference (Final Values)|0.103|Standard Error of the Mean|0.023|<|0.0001||95.0|0.058|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698644|NCT01013753|3121584|Superiority or Other||Mean Difference (Final Values)|0.166|Standard Error of the Mean|0.023|<|0.0001||95.0|0.12|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698990|NCT01009086|3122245|Superiority or Other||||||<|0.017|||||||re-randomization test||||
1698645|NCT01013753|3121584|Superiority or Other||Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.023|<|0.0001||95.0|0.134|0.226|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698646|NCT01013753|3121584|Superiority or Other||Mean Difference (Final Values)|0.161|Standard Error of the Mean|0.023|<|0.0001||95.0|0.116|0.207|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698647|NCT01013753|3121584|Superiority or Other||Mean Difference (Final Values)|0.135|Standard Error of the Mean|0.023|<|0.0001||95.0|0.09|0.18|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698648|NCT01013753|3121584|Superiority or Other||Mean Difference (Final Values)|0.102|Standard Error of the Mean|0.023|<|0.0001||95.0|0.056|0.148|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698649|NCT01013753|3121585|Superiority or Other||Mean Difference (Final Values)|0.152|Standard Error of the Mean|0.022|<|0.0001||95.0|0.11|0.194|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698650|NCT01013753|3121585|Superiority or Other||Mean Difference (Final Values)|0.207|Standard Error of the Mean|0.022|<|0.0001||95.0|0.164|0.25|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698651|NCT01013753|3121585|Superiority or Other||Mean Difference (Final Values)|0.177|Standard Error of the Mean|0.022|<|0.0001||95.0|0.135|0.219|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698652|NCT01013753|3121585|Superiority or Other||Mean Difference (Final Values)|0.151|Standard Error of the Mean|0.021|<|0.0001||95.0|0.11|0.193|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698653|NCT01013753|3121585|Superiority or Other||Mean Difference (Final Values)|0.115|Standard Error of the Mean|0.022|<|0.0001||95.0|0.073|0.158|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698654|NCT01013753|3121586|Superiority or Other||Mean Difference (Final Values)|0.184|Standard Error of the Mean|0.024|<|0.0001||95.0|0.137|0.231|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698655|NCT01013753|3121586|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.024|<|0.0001||95.0|0.203|0.298|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698656|NCT01013753|3121586|Superiority or Other||Mean Difference (Final Values)|0.233|Standard Error of the Mean|0.024|<|0.0001||95.0|0.186|0.28|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698657|NCT01013753|3121586|Superiority or Other||Mean Difference (Final Values)|0.212|Standard Error of the Mean|0.024|<|0.0001||95.0|0.166|0.259|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698658|NCT01013753|3121586|Superiority or Other||Mean Difference (Final Values)|0.163|Standard Error of the Mean|0.024|<|0.0001||95.0|0.116|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698659|NCT01013753|3121587|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.022|<|0.0001||95.0|0.126|0.211|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Form 12 mcg bid minus Placebo||
1698660|NCT01013753|3121587|Superiority or Other||Mean Difference (Final Values)|0.229|Standard Error of the Mean|0.022|<|0.0001||95.0|0.186|0.272|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 20 mcg qd minus Placebo||
1698661|NCT01013753|3121587|Superiority or Other||Mean Difference (Final Values)|0.205|Standard Error of the Mean|0.022|<|0.0001||95.0|0.163|0.248|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 10 mcg qd minus Placebo||
1698662|NCT01013753|3121587|Superiority or Other||Mean Difference (Final Values)|0.182|Standard Error of the Mean|0.021|<|0.0001||95.0|0.14|0.224|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 5 mcg qd minus Placebo||
1698663|NCT01013753|3121587|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.022|<|0.0001||95.0|0.097|0.182|||Mixed Models Analysis|Adjusted using a mixed model with treatment, period and study baseline value as fixed effects; and patients as random effect.|Olo 2 mcg qd minus Placebo||
1698664|NCT01013740|3121591|Superiority or Other||Odds Ratio (OR)|1.5|||||2-Sided|95.0|0.63|3.58|||||||
1698665|NCT01013740|3121596|Superiority or Other||Hazard Ratio (HR)|0.84||||||95.0|0.53|1.35|||||The Pike estimator of the treatment HR was based on the log rank test.||
1698666|NCT01013597|3121601|Superiority or Other (legacy)|||||||0.98|||||||t-test, 2 sided||||
1698667|NCT01013194|3121612|Superiority or Other|||||||0.0437|||||||t-test, 2 sided|||Comparison at 1 year Follow-up|
1698668|NCT01013194|3121613|Superiority or Other|||||||0.0076|||||||t-test, 2 sided|||Comparison at 1 year Follow-up|
1698669|NCT01013194|3121614|Superiority or Other|||||||0.434|||||||Fisher Exact||||
1698670|NCT01012973|3121616|Superiority or Other||Difference in LS Means|0.044|||||2-Sided|95.0|-0.002|0.09|||||As the fixed sequence of secondary endpoints stopped with proportion of neovascularizations developed until week 24, 95% confidence interval is only of descriptive nature.||
1698671|NCT01012973|3121617|Superiority or Other||Difference in LS means|4.2|||||2-Sided|95.0|1.7|6.8|||||As the fixed sequence of secondary endpoints stopped with proportion of neovascularizations developed until week 24, 95% confidence interval is only of descriptive nature.||
1698672|NCT01012973|3121618|Superiority or Other||CMH adjusted Difference|-1.5||||0.5947|2-Sided|95.0|-7.4|4.4||As fixed sequence testing did reject nullhypothesis of change from baseline in CRT until week 24, and this p-value was not below significance level of two-sided <.05, the fixed sequence testing did end with this evaluation.|Cochran-Mantel-Haenszel|Cochrane-Mantel-Haenszel test, stratified by region and baseline BCVA category.||Nullhypothesis of no difference in development of neovascularizations between Eylea and Sham group was tested. (Any neovascularization)|
1698673|NCT01012973|3121619|Superiority or Other||Difference in Least square (LS) means|-239.42|||<|0.0001|2-Sided|95.0|-286.31|-192.53||As fixed sequence testing did reject nullhypothesis of change from baseline in BCVA until week 24, and this p-value was below significance level of two-sided <.05, the fixed sequence testing did continue with next secondary endpoint.|ANCOVA|ANCOVA, stratified by region and baseline BCVA category, baseline central retinal thickness added as covariate.|The difference is calculated as Eylea minus Sham. A negative value indicates Eylea showed a higher reduction in change in central retinal thickness until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in central retinal thickness between Eylea and Sham. If primary efficacy was successful, secondary efficacy end points were to be tested in a pre-specified fixed sequence testing procedure. Change in central retinal thickness was to be tested at second place in this sequence.|
1698674|NCT01012973|3121620|Superiority or Other||Difference in Least square means|14.7|||<|0.0001|2-Sided|95.0|10.8|18.7||As primary efficacy evaluation was significant, and this p-value was below significance level of two-sided <.05, the fixed sequence testing did continue with next secondary endpoint.|ANOVA|ANOVA, adjusting for region and baseline BCVA category as fixed factors.|The difference is calculated as Eylea minus Sham. A positive value indicates Eylea showed a higher change in BCVA total score until week 24 compared to Sham.|Null hypothesis was equality in change from baseline to Week 24 in BCVA total letter score between Eylea and Sham. If primary efficacy was successful, secondary efficacy endpoints were tested in a pre-specified fixed sequence testing procedure. Change in BCVA letter score was to be tested first in this sequence.|
1698675|NCT01012973|3121621|Superiority or Other||CMH adjusted difference|38.3|||<|0.0001|2-Sided|95.0|24.4|52.1|||Cochran-Mantel-Haenszel||The estimate is calculated as Eylea minus Sham. A positive value shows Eylea showed a higher BCVA total score compared to Sham.|Null hypothesis of difference of Eylea minus Sham of 0 was tested. In the database close after Week 24, basis for primary efficacy evaluation, 56 Sham / 96 Eylea subjects were considered as week 24 completers.|
1698676|NCT01012245|3121714|Superiority or Other||Mean value|0.48|Standard Deviation|0.26||||95.0|0.47|0.5||||||Horizontal C/D ratio 3 years (n=1204)|
1698677|NCT01012245|3121714|Superiority or Other||Mean value|0.49|Standard Deviation|0.21||||95.0|0.42|0.57||||||Horizontal C/D ratio 3 years (n=35)|
1698678|NCT01012245|3121714|Superiority or Other||Mean value|0.31|Standard Deviation|0.15||||95.0|0.25|0.38||||||Horizontal C/D ratio 3 years (n=25)|
1698679|NCT01012245|3121714|Superiority or Other||Mean value|0.4|Standard Deviation|0.22||||95.0|0.39|0.41||||||Horizontal C/D ratio 3 years (n=2289)|
1698680|NCT01012245|3121714|Superiority or Other||Mean value|0.43|Standard Deviation|0.24||||95.0|0.43|0.44||||||Horizontal C/D ratio 3 years (n=6102)|
1698681|NCT01012245|3121714|Superiority or Other||Mean value|0.51|Standard Deviation|0.27||||95.0|0.49|0.52||||||Horizontal C/D ratio 2 years (n=1812)|
1698682|NCT01012245|3121714|Superiority or Other||Mean value|0.5|Standard Deviation|0.25||||95.0|0.45|0.56||||||Horizontal C/D ratio 2 years (n=92)|
1698683|NCT01012245|3121714|Superiority or Other||Mean value|0.38|Standard Deviation|0.19||||95.0|0.31|0.45||||||Horizontal C/D ratio 2 years (n=31)|
1698684|NCT01012245|3121714|Superiority or Other||Mean value|0.41|Standard Deviation|0.23||||95.0|0.4|0.42||||||Horizontal C/D ratio 2 years (n=3276)|
1698685|NCT01012245|3121714|Superiority or Other||Mean value|0.45|Standard Deviation|0.25||||95.0|0.44|0.45||||||Horizontal C/D ratio 2 years (n=8427)|
1698686|NCT01012245|3121714|Superiority or Other||Mean value|0.51|Standard Deviation|0.27||||95.0|0.5|0.52||||||Horizontal C/D ratio 1 year (n=2703)|
1698687|NCT01012245|3121714|Superiority or Other||Mean value|0.5|Standard Deviation|0.25||||95.0|0.47|0.53||||||Horizontal C/D ratio 1 year (n=232)|
1698688|NCT01012245|3121714|Superiority or Other||Mean value|0.37|Standard Deviation|0.19||||95.0|0.33|0.42||||||Horizontal C/D ratio 1 year (n=87)|
1698689|NCT01012245|3121714|Superiority or Other||Mean value|0.42|Standard Deviation|0.23||||95.0|0.42|0.43||||||Horizontal C/D ratio 1 year (n=4810)|
1698690|NCT01012245|3121714|Superiority or Other||Mean value|0.45|Standard Deviation|0.25||||95.0|0.45|0.46||||||Horizontal C/D ratio 1 year (n=11433)|
1698691|NCT01012245|3121715|Superiority or Other||Mean value|0.49|Standard Deviation|0.26||||95.0|0.48|0.51||||||Vertical C/D ratio 3 years (n=1283)|
1698692|NCT01012245|3121715|Superiority or Other||Mean value|0.47|Standard Deviation|0.18||||95.0|0.41|0.53||||||Vertical C/D ratio 3 years (n=36)|
1698693|NCT01012245|3121715|Superiority or Other||Mean value|0.33|Standard Deviation|0.14||||95.0|0.27|0.39||||||Vertical C/D ratio 3 years (n=25)|
1698694|NCT01012245|3121715|Superiority or Other||Mean value|0.42|Standard Deviation|0.22||||95.0|0.41|0.43||||||Vertical C/D ratio 3 years (n=2372)|
1698695|NCT01012245|3121715|Superiority or Other||Mean value|0.45|Standard Deviation|0.24||||95.0|0.44|0.45||||||Vertical C/D ratio 3 years (n=6344)|
1698696|NCT01012245|3121715|Superiority or Other||Mean value|0.51|Standard Deviation|0.27||||95.0|0.5|0.53||||||Vertical C/D ratio 2 years (n=1934)|
1698697|NCT01012245|3121715|Superiority or Other||Mean value|0.49|Standard Deviation|0.24||||95.0|0.44|0.54||||||Vertical C/D ratio 2 years (n=95)|
1698698|NCT01012245|3121715|Superiority or Other||Mean value|0.39|Standard Deviation|0.16||||95.0|0.33|0.45||||||Vertical C/D ratio 2 years (n=31)|
1698699|NCT01012245|3121715|Superiority or Other||Mean value|0.43|Standard Deviation|0.23||||95.0|0.42|0.44||||||Vertical C/D ratio 2 years (n=3396)|
1698700|NCT01012245|3121715|Superiority or Other||Mean value|0.46|Standard Deviation|0.25||||95.0|0.46|0.47||||||Vertical C/D ratio 2 years (n=8783)|
1698701|NCT01012245|3121715|Superiority or Other||Mean value|0.51|Standard Deviation|0.27||||95.0|0.5|0.52||||||Vertical C/D ratio 1 year (n=2949)|
1698702|NCT01012245|3121715|Superiority or Other||Mean value|0.5|Standard Deviation|0.24||||95.0|0.47|0.53||||||Vertical C/D ratio 1 year (n=241)|
1698799|NCT01011556|3121879|Superiority or Other||||||<|0.312|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.|||
1698704|NCT01012245|3121715|Superiority or Other||Mean value|0.44|Standard Deviation|0.24||||95.0|0.43|0.44||||||Vertical C/D ratio 1 year (n=4944)|
1698705|NCT01012245|3121715|Superiority or Other||Mean value|0.46|Standard Deviation|0.25||||95.0|0.46|0.47||||||Vertical C/D ratio 1 year (n=11966)|
1698706|NCT01012245|3121717|Superiority or Other||Mean value|16.9|Standard Deviation|3.6||||95.0|16.7|17.1||||||IOP 3 years (n=1251)|
1698707|NCT01012245|3121717|Superiority or Other||Mean value|16.5|Standard Deviation|2.8||||95.0|15.7|17.4||||||IOP 3 years (n=44)|
1698708|NCT01012245|3121717|Superiority or Other||Mean value|17.5|Standard Deviation|2.5||||95.0|16.9|18.1||||||IOP 3 years (n=64)|
1698709|NCT01012245|3121717|Superiority or Other||Mean value|16.8|Standard Deviation|3.2||||95.0|16.7|17.0||||||IOP 3 years (n=1932)|
1698710|NCT01012245|3121717|Superiority or Other||Mean value|17.0|Standard Deviation|3.4||||95.0|16.9|17.1||||||IOP 3 years (n=5469)|
1698711|NCT01012245|3121717|Superiority or Other||Mean value|17.1|Standard Deviation|3.7||||95.0|16.9|17.2||||||IOP 2 years (n=2002)|
1698712|NCT01012245|3121717|Superiority or Other||Mean value|16.6|Standard Deviation|2.8||||95.0|15.9|17.2||||||IOP 2 years (n=83)|
1698713|NCT01012245|3121717|Superiority or Other||Mean value|17.2|Standard Deviation|1.8||||95.0|17.0|17.5||||||IOP 2 years (n=175)|
1698714|NCT01012245|3121717|Superiority or Other||Mean value|16.8|Standard Deviation|2.9||||95.0|16.7|16.9||||||IOP 2 years (n=2808)|
1698715|NCT01012245|3121717|Superiority or Other||Mean value|17.0|Standard Deviation|3.4||||95.0|17.0|17.1||||||IOP 2 years (n=8051)|
1698716|NCT01012245|3121717|Superiority or Other||Mean value|17.6|Standard Deviation|4.1||||95.0|17.5|17.8||||||IOP 1 year (n=3277)|
1698717|NCT01012245|3121717|Superiority or Other||Mean value|16.9|Standard Deviation|3.2||||95.0|16.4|17.3||||||IOP 1 year (n=220)|
1698718|NCT01012245|3121717|Superiority or Other||Mean value|17.3|Standard Deviation|2.2||||95.0|17.1|17.5||||||IOP 1 year (n=357)|
1698719|NCT01012245|3121717|Superiority or Other||Mean value|16.9|Standard Deviation|2.9||||95.0|16.8|17.0||||||IOP 1 year (n=4450)|
1698720|NCT01012245|3121717|Superiority or Other||Mean value|17.2|Standard Deviation|3.4||||95.0|17.2|17.3||||||IOP 1 year (n=11602)|
1698721|NCT01012219|3121718|Superiority or Other||Geometric least-squares mean ratio|1.23|||||2-Sided|90.0|0.96|1.56|||||||
1698722|NCT01012037|3121814|Superiority or Other||Mean Difference (Final Values)|5.3|Standard Error of the Mean|3.0||||95.0|-0.7|11.3|||||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd|
1698723|NCT01012037|3121814|Superiority or Other||Mean Difference (Final Values)|-15.3|Standard Error of the Mean|5.4||0.0047||95.0|-25.8|-4.7|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo|
1698724|NCT01012037|3121814|Superiority or Other||Mean Difference (Final Values)|-10.0|Standard Error of the Mean|5.4||0.0653||95.0|-20.6|0.6|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo|
1698725|NCT01012037|3121815|Superiority or Other||Mean Difference (Final Values)|2.3|Standard Error of the Mean|2.5||||95.0|-2.6|7.3|||||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd|
1698726|NCT01012037|3121815|Superiority or Other||Mean Difference (Final Values)|-18.9|Standard Error of the Mean|4.4|<|0.0001||95.0|-27.6|-10.2|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo|
1698727|NCT01012037|3121815|Superiority or Other||Mean Difference (Final Values)|-16.6|Standard Error of the Mean|4.4|<|0.0002||95.0|-25.3|-7.8|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo|
1698728|NCT01012037|3121816|Superiority or Other||Mean Difference (Final Values)|4.1|Standard Error of the Mean|2.6||||95.0|-1.0|9.2|||||No non-inferiority margin was pre-defined for FPG|Linagliptin 2.5mg bid versus Linagliptin 5mg qd|
1698729|NCT01012037|3121816|Superiority or Other||Mean Difference (Final Values)|-17.8|Standard Error of the Mean|4.6||0.0001||95.0|-26.7|-8.8|||ANCOVA|||Linagliptin 5 mg qd versus Placebo|
1698730|NCT01012037|3121816|Superiority or Other||Mean Difference (Final Values)|-13.7|Standard Error of the Mean|4.6||0.0029||95.0|-22.7|-4.7|||ANCOVA|||Linagliptin 2.5mg bid versus Placebo|
1698731|NCT01012037|3121817|Non-Inferiority or Equivalence|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.07||||95.0|-0.08|0.18||||||Linagliptin 2.5mg bid versus Linagliptin 5mg qd|
1698732|NCT01012037|3121817|Superiority or Other||Mean Difference (Final Values)|-0.82|Standard Error of the Mean|0.12|<|0.0001||95.0|-1.05|-0.59|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo|
1698733|NCT01012037|3121817|Superiority or Other||Mean Difference (Final Values)|-0.77|Standard Error of the Mean|0.12|<|0.0001||95.0|-1.0|-0.54|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo|
1698734|NCT01012037|3121818|Non-Inferiority or Equivalence|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.05||||95.0|-0.1|0.1||||||Linagliptin 2.5mg bid versus Linagliptin 5mg qd|
1698735|NCT01012037|3121818|Superiority or Other||Mean Difference (Final Values)|-0.66|Standard Error of the Mean|0.09|<|0.0001||95.0|-0.84|-0.49|||Mixed Models Analysis|||Linagliptin 5mg qd versus Placebo|
1698736|NCT01012037|3121818|Superiority or Other||Mean Difference (Final Values)|-0.66|Standard Error of the Mean|0.09|<|0.0001||95.0|-0.83|-0.48|||Mixed Models Analysis|||Linagliptin 2.5mg bid versus Placebo|
1698737|NCT01012037|3121819|Non-Inferiority or Equivalence|The pre-defined non-inferiority margin was +0.35|Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.07||||95.0|-0.07|0.19||||||Linagliptin 2.5mg bid versus Linagliptin 5mg qd|
1698738|NCT01012037|3121819|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.11|<|0.0001||95.0|-1.02|-0.58|||ANCOVA|||Linagliptin 5mg qd versus Placebo|
1698739|NCT01012037|3121819|Superiority or Other||Mean Difference (Final Values)|-0.74|Standard Error of the Mean|0.11|<|0.0001||95.0|-0.97|-0.52|||ANCOVA|||Linagliptin 2.5mg bid versus Placebo|
1698740|NCT01011868|3121832|Superiority or Other||Odds Ratio (OR)|3.239||||0.0024|2-Sided|95.0|1.518|6.911|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 78 weeks|
1698741|NCT01011868|3121832|Superiority or Other||Odds Ratio (OR)|1.939||||0.0986|2-Sided|95.0|0.884|4.256|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 78 weeks|
1698742|NCT01011868|3121832|Superiority or Other||Odds Ratio (OR)|2.423||||0.0132|2-Sided|95.0|1.203|4.879|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 54 weeks|
1698743|NCT01011868|3121832|Superiority or Other||Odds Ratio (OR)|1.75||||0.1248|2-Sided|95.0|0.856|3.575|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 54 weeks|
1698744|NCT01011868|3121832|Superiority or Other||Odds Ratio (OR)|4.636||||0.0002|2-Sided|95.0|2.083|10.321|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 18 weeks|
1698745|NCT01011868|3121832|Superiority or Other||Odds Ratio (OR)|4.096||||0.0005|2-Sided|95.0|1.846|9.088|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 18 weeks|
1698746|NCT01011868|3121834|Non-Inferiority or Equivalence|"For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.~If the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison."|Adjusted mean difference|-0.62|Standard Error of the Mean|0.12|<|0.0001|2-Sided|97.5|-0.9|-0.34||Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).|"Change from BL at week 78 - Empagliflozin 25 mg vs Placebo~H0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 25 mg and placebo <0.3%"|
1698747|NCT01011868|3121834|Non-Inferiority or Equivalence|"For non-inferiority, a one-sided test at the significance level of 0.0125 was performed using a chosen margin of 0.3% difference between each dose of empagliflozin and placebo.~If the non-inferiority of empagliflozin to placebo with respect to change from baseline in HbA1c after 78 weeks of treatment could be concluded for a specific dose, subsequent testing of superiority was performed at the significance level of 0.025 for the relevant empagliflozin dose versus placebo comparison."|Adjusted mean difference|-0.46|Standard Error of the Mean|0.12|<|0.0001|2-Sided|97.5|-0.73|-0.19||Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment as fixed effect(s).|"Change from BL at week 78 - Empagliflozin 10 mg vs Placebo~H0,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo ≥0.3% H1,1b: The change from baseline to Week 78 in HbA1c between empagliflozin 10 mg and placebo <0.3%"|
1698748|NCT01011868|3121834|Superiority or Other||Adjusted mean difference|-0.74|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-0.95|-0.52|||Mixed Models Analysis||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Change from BL at week 54 - Empagliflozin 25 mg vs Placebo|
1698749|NCT01011868|3121834|Superiority or Other||Adjusted mean difference|-0.47|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-0.68|-0.26|||Mixed Models Analysis||Model includes baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Change from BL at week 54 - Empagliflozin 10 mg vs Placebo|
1698750|NCT01011868|3121836|Superiority or Other||Adjusted mean difference|-3.12|Standard Error of the Mean|1.15||0.0073|2-Sided|95.0|-5.39|-0.85|||Mixed Models Analysis|Model includes, baseline weight, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects|Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 78 - Empagliflozin 25 mg vs Placebo|
1698751|NCT01011868|3121836|Superiority or Other||Adjusted mean difference|-3.63|Standard Error of the Mean|1.1||0.0012|2-Sided|95.0|-5.81|-1.45|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 78 - Empagliflozin 10 mg vs Placebo|
1698752|NCT01011868|3121836|Superiority or Other||Adjusted mean difference|-2.17|Standard Error of the Mean|0.49|<|0.0001|2-Sided|95.0|-3.13|-1.22|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 54 - Empagliflozin 25 mg vs Placebo|
1698753|NCT01011868|3121836|Superiority or Other||Adjusted mean difference|-1.97|Standard Error of the Mean|0.47|<|0.0001|2-Sided|95.0|-2.89|-1.05|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 54 - Empagliflozin 10 mg vs Placebo|
1698754|NCT01011868|3121836|Superiority or Other||Adjusted mean difference|-0.87|Standard Error of the Mean|0.99|<|0.3818|2-Sided|95.0|-2.81|1.08|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 18 - Empagliflozin 25 mg vs Placebo|
1698755|NCT01011868|3121836|Superiority or Other||Adjusted mean difference|-2.04|Standard Error of the Mean|0.95|<|0.032|2-Sided|95.0|-3.9|-0.18|||Mixed Models Analysis||Model includes baseline weight, baseline HbA1c as linear covariates, geographical region, treatment, visit and visit by treatment interaction as fixed effects|Change from BL at week 18 - Empagliflozin 10 mg vs Placebo|
1698773|NCT01011868|3121840|Superiority or Other||Odds Ratio (OR)|2.802|||<|0.0002|2-Sided|95.0|1.639|4.789|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 78 weeks|
1698774|NCT01011868|3121840|Superiority or Other||Odds Ratio (OR)|3.825|||<|0.0001|2-Sided|95.0|2.268|6.451|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 54 weeks|
1698800|NCT01011556|3121879|Superiority or Other||||||<|0.406|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.|||
1698756|NCT01011868|3121837|Superiority or Other||Adjusted mean difference|-5.92|Standard Error of the Mean|2.25||0.009|2-Sided|97.5|-11.0|-0.85||Hierarchical testing approach was applied to Empagliflozin 25 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA|Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)||"Empagliflozin versus Placebo 25 mg at 78 weeks~H0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 25 mg and placebo"|
1698757|NCT01011868|3121837|Superiority or Other||Adjusted mean difference|-6.66|Standard Error of the Mean|2.18||0.0024|2-Sided|97.5|-11.56|-1.77||Hierarchical testing approach was applied to Empagliflozin 10 mg vs Placebo. If null hypothesis is rejected for the primary endpoint, at 0.025 (2-sided), testing of the key secondary endpoints continued in a hierarchical fashion for the same dose.|ANCOVA|Model for Week 78 includes baseline basal insulin, baseline HbA1c as linear covariate(s) and geographical region, treatment as fixed effect(s)||"Empagliflozin versus Placebo 10 mg at 78 weeks~H0,1a: No difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo H1,1a: A difference in change from baseline to Week 78 in basal insulin dose between Empagliflozin 10 mg and placebo"|
1698758|NCT01011868|3121837|Superiority or Other||Adjusted mean difference|-5.69|Standard Error of the Mean|2.49||0.0237|2-Sided|95.0|-10.62|-0.77|||Mixed Models Analysis||Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effect(s).|Empagliflozin versus Placebo 25 mg at 54 weeks|
1698759|NCT01011868|3121837|Superiority or Other||Adjusted mean difference|-5.58|Standard Error of the Mean|2.4||0.0213|2-Sided|95.0|-10.32|-0.84|||Mixed Models Analysis||Week 54 model includes, baseline basal insulin, baseline HbA1c as linear covariate(s), geographical region, treatment, visit and visit by treatment interaction as fixed effects.|Empagliflozin versus Placebo 10 mg at 54 weeks|
1698760|NCT01011868|3121838|Superiority or Other||Adjusted mean difference|-12.39|Standard Error of the Mean|5.23||0.0185|2-Sided|95.0|-22.69|-2.1|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 25 mg vs Placebo|
1698761|NCT01011868|3121838|Superiority or Other||Adjusted mean difference|-4.73|Standard Error of the Mean|5.07||0.3517||95.0|-14.71|5.25|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 10 mg vs Placebo|
1698762|NCT01011868|3121838|Superiority or Other||Adjusted mean difference|-19.42|Standard Error of the Mean|5.3||0.0003|2-Sided|95.0|-29.84|-8.99|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 25 mg vs Placebo|
1698763|NCT01011868|3121838|Superiority or Other||Adjusted mean difference|-10.2|Standard Error of the Mean|5.15|<|0.0484|2-Sided|95.0|-20.33|-0.07|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 10 mg vs Placebo|
1698764|NCT01011868|3121838|Superiority or Other||Adjusted mean difference|-31.01|||<|0.0001|2-Sided|95.0|-41.62|-20.39|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 25 mg vs Placebo|
1698765|NCT01011868|3121838|Superiority or Other||Adjusted mean difference|-25.12|Standard Error of the Mean|5.22|<|0.0001|2-Sided|95.0|-35.38|-14.86|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 10 mg vs Placebo|
1698766|NCT01011868|3121839|Superiority or Other||Adjusted mean difference|-11.95|Standard Error of the Mean|5.23||0.0229|2-Sided|95.0|-22.24|-1.67|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 25 mg vs Placebo|
1698767|NCT01011868|3121839|Superiority or Other||Adjusted mean difference|-5.03|Standard Error of the Mean|5.07||0.3216|2-Sided|95.0|-15.01|4.94|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 78 - Empagliflozin 10 mg vs Placebo|
1698768|NCT01011868|3121839|Superiority or Other||Adjusted mean difference|-19.16|Standard Error of the Mean|5.16||0.0002|2-Sided|95.0|-29.31|-9.01|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 25 mg vs Placebo|
1698769|NCT01011868|3121839|Superiority or Other||Adjusted mean difference|-10.75|Standard Error of the Mean|5.02||0.0328|2-Sided|95.0|-20.62|-0.89|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 54 - Empagliflozin 10 mg vs Placebo at 18 weeks|
1698770|NCT01011868|3121839|Superiority or Other||Adjusted mean difference|-34.21|Standard Error of the Mean|4.81|<|0.0001|2-Sided|95.0|-43.67|-24.76|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 25 mg vs Placebo at 18 weeks|
1698771|NCT01011868|3121839|Superiority or Other||Adjusted mean difference|-28.4|Standard Error of the Mean|4.65|<|0.0001|2-Sided|95.0|-37.54|-19.27|||Mixed Models Analysis|Model includes, baseline FPG, baseline HbA1c as covariates, geographic region, treatment, visit and visit by treatment interaction as fixed effects||Change from BL at week 18 - Empagliflozin 10 mg vs Placebo|
1698772|NCT01011868|3121840|Superiority or Other||Odds Ratio (OR)|3.527|||<|0.0001|2-Sided|95.0|2.051|6.066|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 78 weeks|
1698798|NCT01011556|3121879|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.|||
1698775|NCT01011868|3121840|Superiority or Other||Odds Ratio (OR)|3.471|||<|0.0001|2-Sided|95.0|2.077|5.802|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 10 mg vs Placebo at 54 weeks|
1698776|NCT01011868|3121840|Superiority or Other||Odds Ratio (OR)|4.883|||<|0.0001|2-Sided|95.0|2.859|8.338|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c||Empagliflozin 25 mg vs Placebo at 18 weeks|
1698777|NCT01011868|3121840|Superiority or Other||Odds Ratio (OR)|5.518|||<|0.0001|2-Sided|95.0|3.262|9.334|||Regression, Logistic|Logistic regression includes treatment, geographical region and baseline HbA1c.||Empagliflozin 10 mg vs Placebo at 18 weeks|
1698778|NCT01011868|3121841|Superiority or Other||Adjusted mean difference|-0.7|Standard Error of the Mean|0.1|<|0.0001|2-Sided|97.5|-0.93|-0.47||Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.|ANCOVA|ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.|The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.|"The null and alternative hypotheses to be tested:~H0,2: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo~H1,2: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 25 mg and placebo"|
1698779|NCT01011868|3121841|Superiority or Other||Adjusted mean difference|-0.56|Standard Error of the Mean|0.1|<|0.0001|2-Sided|97.5|-0.78|-0.33||Hypotheses were tested at significance level of 0.025, which is half of overall alpha of 0.05, split equally between 2 treatment comparisons. This maintained the overall type-I (alpha) at 5%. There was no a priori assumption on testing order.|ANCOVA|ANCOVA that included treatment group and geographic region as fixed effects along with baseline HbA1c as covariate.|The primary analysis consisted of the pair-wise comparisons between each dose of empagliflozin versus placebo using the adjusted means from the model.|"The null and alternative hypotheses to be tested:~H0,1: No difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo~H1,1: A difference in change from baseline to Week 18 in HbA1c between empagliflozin 10 mg and placebo"|
1698780|NCT01011816|3121846|Superiority or Other|||||||0.52|||||||Fisher Exact|||Null: No differenc between the percent success of Saline and BIOSTAT BIOLOGX|
1698781|NCT01011738|3121857|Superiority or Other||Odds Ratio (OR)|1.528||||0.0149|2-Sided|95.0|1.086|2.15||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg negative participants, ALT ratio was analysed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.|
1698782|NCT01011738|3121857|Superiority or Other||Odds Ratio (OR)|0.191||||0.0042|2-Sided|95.0|0.062|0.594|||Wald-Chi-Square test|||In HBeAg negative participants, HBsAg in log10 IU/mL at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis B.|
1698783|NCT01011738|3121857|Superiority or Other||Odds Ratio (OR)|0.155||||0.0033|2-Sided|95.0|0.045|0.539||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg negative participants, HBsAg in log10 IU/mL at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.|
1698784|NCT01011738|3121861|Superiority or Other||Odds Ratio (OR)|0.851||||0.0369|2-Sided|95.0|0.732|0.99||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Weight in kg was analyzed as independent predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.|
1698785|NCT01011738|3121861|Superiority or Other||Odds Ratio (OR)|3.595||||0.0019|2-Sided|95.0|1.603|8.063||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Log10-drop HBsAg at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis B.|
1698786|NCT01011738|3121861|Superiority or Other||Odds Ratio (OR)|3.349||||0.0022|2-Sided|95.0|1.542|7.271||Multiple logistic regression were run in stepwise procedure with significance level of 0.05 to stay, considering all pre and on-treatment factors identified by univariate logistic regression to be associated with HBsAg clearance 3 yrs post-treatment.|Wald-Chi-Square test|||In HBeAg positive participants, Log10-drop HBsAg at Week 24 was analyzed as the predictor factor of HBsAg clearance at 3 years post-treatment in analysis A.|
1698787|NCT01011556|3121878|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.|||
1698788|NCT01011556|3121878|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.|||
1698789|NCT01011556|3121878|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.|||
1698790|NCT01011556|3121879|Superiority or Other|||||||0.988|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.|||
1698791|NCT01011556|3121879|Superiority or Other|||||||0.112|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.|||
1698792|NCT01011556|3121879|Superiority or Other|||||||0.003|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.|||
1698793|NCT01011556|3121879|Superiority or Other|||||||0.997|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.|||
1698794|NCT01011556|3121879|Superiority or Other|||||||0.011|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.|||
1698795|NCT01011556|3121879|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.|||
1698796|NCT01011556|3121879|Superiority or Other||||||<|0.952|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.|||
1698797|NCT01011556|3121879|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.|||
1698991|NCT01009086|3122246|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1698801|NCT01011556|3121879|Superiority or Other||||||<|0.822|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.|||
1698802|NCT01011556|3121880|Superiority or Other|||||||0.047|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.|||
1698803|NCT01011556|3121880|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.|||
1698804|NCT01011556|3121880|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 12 months.|||
1698805|NCT01011556|3121880|Superiority or Other||||||<|0.029|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.|||
1698806|NCT01011556|3121880|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.|||
1698807|NCT01011556|3121880|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 6 months.|||
1698808|NCT01011556|3121880|Superiority or Other||||||<|0.003|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.|||
1698809|NCT01011556|3121880|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.|||
1698810|NCT01011556|3121880|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 3 months.|||
1698811|NCT01011556|3121880|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.|||
1698812|NCT01011556|3121880|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.|||
1698813|NCT01011556|3121880|Superiority or Other||||||<|0.001|||||||Wilcoxon Rank Sum Test|Pairwise comparison p-value at 1 month.|||
1698814|NCT01011556|3121881|Superiority or Other||Difference in Least Square Means|-6.19|Standard Error of the Mean|0.802||0.001|2-Sided|90.0|-7.51|-4.86||p-value is for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment*visit interaction. Repeat measure occurred at each visit.|||
1698815|NCT01011556|3121881|Superiority or Other||Difference in Least Square Means|-7.46|Standard Error of the Mean|0.83||0.001|2-Sided|90.0|-8.835|-6.091||p-value for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment*visit interaction. Repeat measure occurred at each visit.|||
1698816|NCT01011556|3121881|Superiority or Other||Difference in Least Square Means|-7.5|Standard Error of the Mean|0.818|<|0.001|2-Sided|90.0|-8.856|-6.151||p-value is for change in BMD at 12 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment*visit interaction. Repeat measure occurred at each visit.|||
1698817|NCT01011556|3121881|Superiority or Other||Difference in Least Square Means|-3.53|Standard Error of the Mean|0.665|<|0.001|2-Sided|90.0|-4.627|-2.43||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment*visit interaction. Repeat measure occurred at each visit.|||
1698818|NCT01011556|3121881|Superiority or Other||Difference in Least Square Means|-3.94|Standard Error of the Mean|0.692|<|0.001|2-Sided|90.0|-5.086|-2.8||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment*visit interaction. Repeat measure occurred at each visit.|||
1698819|NCT01011556|3121881|Superiority or Other||Difference in Least Square Means|-4.53|Standard Error of the Mean|0.687|<|0.001|2-Sided|90.0|-5.663|-3.392||p-value is for change in BMD at 6 months|Mixed Models Analysis|MMRM Model: Percentage change in BMD = treatment+baseline+pooled site+visit+treatment*visit interaction. Repeat measure occurred at each visit.|||
1698820|NCT01011556|3121882|Superiority or Other||Difference in Least Square Means|-3.56|||<|0.001|2-Sided|90.0|-4.652|-2.464|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.|||
1698821|NCT01011556|3121882|Superiority or Other||Difference in Least Square Means|-3.87|||<|0.001|2-Sided|90.0|-5.006|-2.727|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.|||
1698822|NCT01011556|3121882|Superiority or Other||Difference in Least Square Means|-4.58|||<|0.001|2-Sided|90.0|-5.716|-3.452|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.|||
1698823|NCT01011556|3121883|Non-Inferiority or Equivalence|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-6.17|||<|0.001|2-Sided|90.0|-7.448|-4.891|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.|||
1698824|NCT01011556|3121883|Non-Inferiority or Equivalence|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-7.48|||<|0.001|2-Sided|90.0|-8.822|-6.144|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.|||
1698825|NCT01011556|3121883|Non-Inferiority or Equivalence|A noninferiority margin of 3.5% was used.|Difference in Least Square Means|-7.17|||<|0.001|2-Sided|90.0|-8.489|-5.851|||ANCOVA|Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.|||
1698826|NCT01011465|3121884|Superiority or Other||Mean Difference (Final Values)|0.01||||0.95||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.|
1698827|NCT01011465|3121884|Superiority or Other||Mean Difference (Final Values)|0.08||||0.56||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.|
1698828|NCT01011465|3121884|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.83||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups had similar threat/challenge scores during the speech task.|
1698829|NCT01011465|3121885|Superiority or Other||Mean Difference (Final Values)|0.64||||0.25||95.0|||||ANOVA|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.|
1698830|NCT01011465|3121885|Superiority or Other||Mean Difference (Final Values)|-0.96||||0.08||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.|
1698831|NCT01011465|3121885|Superiority or Other||Mean Difference (Final Values)|0.42||||0.43||95.0|||||t-test, 2 sided|||The null hypothesis states that both groups will have similar PANAS negative affect score change in response to stress.|
1698832|NCT01011465|3121886|Superiority or Other||Mean Difference (Final Values)|-1.01||||0.52||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.|
1698833|NCT01011465|3121886|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.89||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.|
1698834|NCT01011465|3121886|Superiority or Other||Mean Difference (Final Values)|3.4||||0.03||95.0|||||t-test, 2 sided|||The null hypothesis is that both groups will have similar rise in SBP in response to stress.|
1698835|NCT01011439|3121893|Superiority||Single proportion|0.44|||<|0.001|2-Sided|95.0|0.31|0.59|||Fisher Exact|||H0:p</=17% vs. H1:p>17%, with an interesting PFS-3 rate of 33% or higher; Power=80%; Alpha(1-sided)=5%, 54 evaluable patients are required for a Simon optimal two stage design trial. If at least 4 successes among the first 17 evaluable patients are observed in the 1st stage, patients’ enrollment proceed up to the final analysis where at least 14/54 successes (PFS-3 rate ≥ 25.9%) must be required to reject the null hypothesis.|
1698836|NCT01011413|3121902|Superiority or Other (legacy)||difference between proportions|0.05||||0.05|2-Sided|95.0||||P-value not adjusted for multiple comparisons|Chi-squared||||
1698837|NCT01011413|3121903|Non-Inferiority|Non-inferiority will be defined as the lower 95% confidence limit of the difference in percentages of patients with undetectable viral load lying above -10% (i.e. a non-inferiority margin of 10%).||||||0.05||||||No adjustment for multiple comparisons|Chi-squared|||To ensure the per protocol (PP) analysis has 90% power to demonstrate non-inferiority, the sample size was inflated for patients who switch treatment for toxicity. This is estimated to be no more than 10% randomised patients. To ensure 90% power to demonstrate non-inferiority in the ITT and PP analyses, a total of 630 (315 per arm) patients will be randomised giving 93% power for the ITT analysis. Null hypothesis: no statistically significant difference between the 600mg and 400mg EFV regimens.|
1698838|NCT01011413|3121903|Non-Inferiority|"Only the primary endpoint is assessed in terms of non-inferiority. All other comparisons are tests for superiority and are considered statistically significant at a two-sided alpha=0.05.~Non-inferiority of EFV 400 mg was defined as the lower 95% confidence interval (CI) of the difference between groups in the proportion of viral load below 200 copies/mL at week 48 lying above -10%."||||||0.05||||||No adjustments were made for multiple comparisons|Pearson's chi-squared|Pearson's chi-squared or Fisher's exact test derived p value was used||Sample size calculation assumes 85% of participants randomised to 600mg EFV arm will have plasma HIV RNA <200 copies/ml at 48 weeks. Assuming no difference between randomised treatments in proportion with plasma HIV RNA <200 copies/mL, to have 90% power to demonstrate non-inferiority in the intention to treat (ITT) analysis using a 10% non-inferiority margin will require 286 participants per arm, making a total of 572 participants. Power for modified ITT analysis was 93%.|
1698839|NCT01011153|3121923|Superiority or Other||Kappa|0.256|Standard Error of the Mean|0.001||||0.0|||||||There is no threshold level-this is a measurement of variability among responses provided by the participants.||
1698840|NCT01011153|3121923|Superiority or Other||Kappa|0.2|Standard Error of the Mean|0.003||||0.0|||||||There is no threshold level-this is a measurement of variability among responses provided by the participants.||
1698841|NCT01011153|3121923|Superiority or Other||Kappa|0.276|Standard Error of the Mean|0.002||||0.0|||||||There is no threshold level-this is a measurement of variability among responses provided by the participants.||
1698842|NCT01011153|3121923|Superiority or Other||Kappa|0.313|Standard Error of the Mean|0.003||||0.0|||||||There is no threshold level-this is a measurement of variability among responses provided by the participants.||
1698843|NCT01011153|3121924|Superiority or Other||Mean Difference (Final Values)|-0.41|Standard Deviation|0.05|<|0.0001|2-Sided|95.0|-0.51|-0.3|||ANOVA|||Specificity|
1698844|NCT01011153|3121924|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Deviation|0.05|<|0.0001|2-Sided|95.0|-0.53|-0.31|||ANOVA|||Specificity|
1698845|NCT01011153|3121924|Superiority or Other||Mean Difference (Final Values)|-0.36|Standard Deviation|0.05|<|0.0001|2-Sided|95.0|-0.46|-0.25|||ANOVA|||Specificity|
1698846|NCT01011153|3121924|Superiority or Other||Mean Difference (Final Values)|0.26|Standard Deviation|0.03|<|0.0001|2-Sided|95.0|0.19|0.33|||ANOVA|||Sensitivity|
1698847|NCT01011153|3121924|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Deviation|0.04|<|0.0001|2-Sided|95.0|0.16|0.31|||ANOVA|||Sensitivity|
1698848|NCT01011153|3121924|Superiority or Other||Mean Difference (Final Values)|0.26|Standard Deviation|0.04|<|0.0001|2-Sided|95.0|0.19|0.34|||ANOVA|||Sensitivity|
1698849|NCT01011153|3121925|Non-Inferiority or Equivalence|Sample sizes computed based on data from smaller studies provided 90% power for the comparison of sensitivity. Under the alternative hypothesis that the biopsy sensitivity of MelaFind would be 0.10 greater than the average biopsy/referral sensitivity of physicians (combined or separate), the probability that a 95% CI lies entirely above zero will be at least 90% when the standard error of the estimated difference is at most 0.0308.|Mean Difference (Final Values)|0.25|Standard Deviation|0.03|<|0.0001|2-Sided|95.0|0.18|0.32|||ANOVA|||Using True Positives/All Positives, sensitivity values were calculated for MelaFind as well as the average of the 110 dermatologists.|
1698850|NCT01010971|3121959|Superiority or Other||Mean Difference (Final Values)|0.64|||||2-Sided|95.0|0.33|0.95|||||||
1698851|NCT01010971|3121959|Superiority or Other||Mean Difference (Final Values)|0.62||||0.0124|2-Sided|95.0|0.3|0.94||Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons|ANCOVA||||
1698852|NCT01010971|3121960|Superiority or Other||Mean Difference (Final Values)|0.52||||0.0124|2-Sided|95.0|0.15|0.89||Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons|
1698853|NCT01010971|3121960|Superiority or Other||Mean Difference (Final Values)|0.34||||0.1444|2-Sided|95.0|-0.03|0.71||Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons|ANCOVA|||Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons|
1698854|NCT01010971|3121961|Superiority or Other||Mean Difference (Final Values)|0.19|||<|0.0001|2-Sided|95.0|0.08|0.29|||ANCOVA|||Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons|
1698855|NCT01010971|3121961|Superiority or Other||Mean Difference (Final Values)|0.18|||<|0.0001|2-Sided|95.0|0.07|0.29|||ANCOVA|||Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons|
1698992|NCT01009086|3122246|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1698856|NCT01010971|3121962|Superiority or Other||Mean Difference (Final Values)|1.04|||<|0.0001|2-Sided|95.0|0.61|1.46||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.|
1698857|NCT01010971|3121962|Superiority or Other||Mean Difference (Final Values)|1.02|||<|0.0001|2-Sided|95.0|0.59|1.45||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.|
1698858|NCT01010906|3121966|Superiority or Other||Geometric Least-Square Mean Ratio|6.16|||||2-Sided|90.0|3.9|9.71|||||||
1698859|NCT01010906|3121966|Superiority or Other||Geometric Least-Square Mean Ratio|2.21|||||2-Sided|90.0|1.21|4.03|||||||
1698860|NCT01010906|3121966|Superiority or Other||Geometric Least-Square Mean Ratio|1.57|||||2-Sided|90.0|0.76|3.24|||||||
1698861|NCT01010906|3121967|Non-Inferiority or Equivalence|If the 90% Confidence Interval falls within the interval [0.50, 2.00], then treatment of HI participants is similar to treatment of healthy matched for severe HI participants.|Geometric Least-Square Mean Ratio|8.42|||||2-Sided|90.0|5.2|13.64|||||||
1698862|NCT01010906|3121967|Non-Inferiority or Equivalence|If the 90% Confidence Interval falls within the interval [0.50, 2.00], then treatment of HI participants is similar to treatment of healthy matched for moderate HI participants.|Geometric Least-Square Mean Ratio|3.11|||||2-Sided|90.0|1.6|6.04|||||||
1698863|NCT01010906|3121967|Non-Inferiority or Equivalence|If the 90% Confidence Interval falls within the interval [0.50, 2.00], then treatment of HI participants is similar to treatment of healthy matched for mild HI participants.|Geometric Least-Square Mean Ratio|1.82|||||2-Sided|90.0|0.96|3.43|||||||
1698864|NCT01010633|3122009|Superiority or Other||Mean Difference (Final Values)|31.0|||<|0.001|2-Sided|95.0|21.4|40.7|||Chi-squared||||
1698865|NCT01010633|3122011|Superiority or Other||Mean Difference (Final Values)|14.3|||<|0.001|2-Sided|95.0|5.7|22.9|||Chi-squared||||
1698866|NCT01010477|3122031|Superiority or Other|||||||0.632||||||threshold for statistical significance: p< 0.05|Fisher Exact|||Fisher Exact test (2-sided)|
1698867|NCT01010230|3122039|Non-Inferiority or Equivalence|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.28||||0.06|2-Sided|95.0|0.09|0.46||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.|
1698868|NCT01010230|3122040|Non-Inferiority or Equivalence|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|-0.02||||0.88|2-Sided|95.0|-0.22|0.18||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.|
1698869|NCT01010230|3122041|Non-Inferiority or Equivalence|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.08||||0.38|2-Sided|95.0|-0.04|0.2||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.|
1698870|NCT01010230|3122042|Non-Inferiority or Equivalence|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.13||||0.17|2-Sided|95.0|0.0|0.26||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.|
1698871|NCT01010230|3122043|Non-Inferiority or Equivalence|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.2||||0.08|2-Sided|95.0|0.06|0.34||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.|
1698872|NCT01010230|3122044|Superiority or Other||Mean Difference (Final Values)|0.67||||0.73|2-Sided|95.0|-2.02|3.33||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.|
1698873|NCT01010230|3122045|Superiority or Other||Mean Difference (Final Values)|1.29||||0.4|2-Sided|95.0|-0.69|3.11||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.|
1698874|NCT01010230|3122046|Superiority or Other||Mean Difference (Final Values)|0.34||||0.91|2-Sided|95.0|-4.05|4.68||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.|
1698875|NCT01010230|3122047|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.97|2-Sided|95.0|-4.24|4.05||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage (from general linear model).||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.|
1698876|NCT01010230|3122048|Superiority or Other||Mean Difference (Final Values)|3.19||||0.12|2-Sided|95.0|0.43|5.95||The threshold for significance was established a priori at alpha=0.05.|ANOVA|Adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8%3 we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.|
1698877|NCT01010230|3122049|Superiority or Other||Mean Difference (Final Values)|1.16||||0.85|2-Sided|95.0|-6.93|9.25||The threshold for significance was established a priori at alpha=0.05|ANOVA|BMC was normalized for height and adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.|
1698878|NCT01010230|3122050|Non-Inferiority or Equivalence|The power calculation was based on the primary aim and is provided above.|Mean Difference (Final Values)|0.18||||0.18|2-Sided|95.0|0.0|0.35||The threshold for significance was established a priori at alpha=0.05.|t-test, 2 sided|||Active and placebo group means were compared with a 2-sample t-test after log-transforming the variable.|
1698879|NCT01010230|3122051|Superiority or Other||Mean Difference (Final Values)|-1.24||||0.69|2-Sided|95.0|-5.59|3.11||The threshold for significance was established a priori at alpha=0.05.|ANOVA|BMC was normalized for height and adjusted for sex and tanner stage.||The power estimates were based on two-sided two-sample t-tests. With 30 subjects in each of the two arms and assuming no change in the control arm (0% change) and assuming the common standard deviation (SD) of 6.8% we estimated 87% power to detect an improvement of 5.5% change in the intervention arm, with type I error control α=0.05.|
1698880|NCT01010061|3122071|Superiority or Other||Hazard Ratio (stratified)|0.25|||<|0.0001|2-Sided|95.0|0.19|0.35|||Log Rank, Stratified|Stratified by Binet stage at Baseline.|||
1698881|NCT01010061|3122073|Superiority or Other||Hazard Ratio (stratified)|0.19|||<|0.0001|2-Sided|95.0|0.13|0.28|||Log Rank, Stratified|Stratified by Binet stage at Baseline.|||
1698882|NCT01010061|3122074|Superiority or Other||Hazard Ratio (HR)|0.68||||0.0196|2-Sided|95.0|0.49|0.94|||Log Rank, Stratified||||
1698883|NCT01010061|3122075|Superiority||Hazard Ratio (HR)|0.19|||<|0.0001|2-Sided|95.0|0.15|0.26|||Log Rank, Stratified||Stratified by Binet stage at Baseline.||
1698884|NCT01010061|3122076|Superiority||Difference in Response Rates|45.1|||<|0.0001|2-Sided|95.0|34.7|55.5|||Chi-squared|||Includes subjects with best overall response: CR, CRi, PR or nPR.|
1698885|NCT01010061|3122079|Superiority or Other||Hazard Ratio (HR)|0.19|||<|0.0001|2-Sided|95.0|0.14|0.27|||Log Rank, Stratified||Stratified by Binet stage at Baseline.||
1698886|NCT01010061|3122081|Superiority or Other||Hazard Ratio (HR)|0.21|||<|0.0001|2-Sided|95.0|0.16|0.28||Type I error controlled through closed test procedure.|Log Rank, Stratified||Stratified by Binet stage at Baseline.||
1698887|NCT01010009|3122082|Superiority or Other||||||<|0.05|||||||ANOVA|||An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.|
1698888|NCT01010009|3122082|Superiority or Other||||||<|0.05|||||||ANOVA|||An omnibus ANOVA was carried out with a priori planned comparisons using the mean squares error term from this ANOVA.|
1698889|NCT01010009|3122083|Superiority or Other||||||>|0.05|||||||ANOVA|||Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.|
1698890|NCT01010009|3122083|Superiority or Other||||||>|0.05|||||||ANOVA|||Performance on each cognitive task was assessed via omnibus ANOVA with a priori planned comparisons.|
1698891|NCT01010009|3122084|Superiority or Other||||||<|0.05|||||||ANOVA|||Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.|
1698892|NCT01010009|3122084|Superiority or Other||||||>|0.05|||||||ANOVA|||Data was analysed by omnibus ANOVA with a priori planned comparisons utilizing the mean squares error term from this ANOVA.|
1698893|NCT01009814|3122134|Other||Mean Difference (Net)|-0.3203|Standard Error of the Mean|0.1993||0.1155|2-Sided|90.0|-0.6555|0.0149|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.|
1698894|NCT01009814|3122134|Other||Mean Difference (Net)|-0.3619|Standard Error of the Mean|0.1988||0.0759|2-Sided|90.0|-0.6962|-0.0275|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.|
1698895|NCT01009814|3122134|Other||Mean Difference (Net)|-0.0415|Standard Error of the Mean|0.1993||0.8359|2-Sided|90.0|-0.3768|0.2937|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.|
1698896|NCT01009814|3122134|Other||Mean Difference (Net)|-0.3796|Standard Error of the Mean|0.2043||0.0702|2-Sided|90.0|-0.7232|-0.036|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.|
1698897|NCT01009814|3122134|Other||Mean Difference (Net)|-0.0592|Standard Error of the Mean|0.2045||0.7734|2-Sided|90.0|-0.4032|0.2847|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.|
1698898|NCT01009814|3122134|Other||Mean Difference (Net)|-0.0177|Standard Error of the Mean|0.2043||0.9314|2-Sided|90.0|-0.3613|0.3259|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.|
1698899|NCT01009814|3122134|Other||Mean Difference (Net)|-0.4885|Standard Error of the Mean|0.2075||0.0233|2-Sided|90.0|-0.8375|-0.1395|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.|
1698900|NCT01009814|3122134|Other||Mean Difference (Net)|-0.1682|Standard Error of the Mean|0.2055||0.4178|2-Sided|90.0|-0.5139|0.1775|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.|
1698901|NCT01009814|3122134|Other||Mean Difference (Net)|-0.1266|Standard Error of the Mean|0.2076||0.5452|2-Sided|90.0|-0.4758|0.2225|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.|
1698902|NCT01009814|3122134|Other||Mean Difference (Net)|-0.1089|Standard Error of the Mean|0.212||0.6102|2-Sided|90.0|-0.4656|0.2477|||ANCOVA|||Null hypothesis was that there was 0 difference in mean log10 decrease in HIV RNA at Day 9 between two groups.|
1698903|NCT01009645|3122138|Superiority or Other||||||<|0.05|||||||ANOVA|used Scheffe's post-hoc analysis|||
1698904|NCT01009645|3122139|Superiority or Other||||||<|0.05||||||The a priori threshold for statistical significance was p <0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The third contrast assessed whether the FO and the FMR message conditions were significantly different.|
1698905|NCT01009645|3122139|Superiority or Other||||||<|0.05||||||The a priori threshold for statistical significance was p <0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The second contrast assessed whether the FO and FMR conditions were significantly different from the FM message.|
1698906|NCT01009645|3122139|Superiority or Other||||||<|0.05||||||The a priori threshold for statistical significance was p <0.0167 as the p-value was adjusted for multiple comparisons (three planned contrasts).|Contrast Analysis|Bonferroni correction used (3 planned contrasts)||Contrast analysis was used to assess difference in vaccination status. The first contrast assessed whether or not the three newly created messages (Fact Only (FO), Fact/Myth (FM), and Fact/Myth/Refutation (FMR)) were as a group significantly different than the control message.|
1698907|NCT01009619|3122143|Superiority or Other||||||<|0.05|||||||Chi-squared, Corrected|||The frequency or rate of specific events (i.e. acute rejection, cytomegalovirus (CMV) and non-CMV infections) was calculated by determining the number of events per year of study time for each subject, correcting for CMV-mismatch status.|
1698908|NCT01009619|3122144|Superiority or Other||||||<|0.05|||||||Chi-squared, Corrected|||The frequency or rate of specific events (i.e. acute rejection, cytomegalovirus (CMV) and non-CMV infections) was calculated by determining the number of events per year of study time for each subject, correcting for CMV-mismatch status.|
1698909|NCT01009554|3122151|Superiority or Other||Least Squares Mean Difference|0.273|Standard Error of the Mean|0.0669|<|0.001|2-Sided|95.0|0.14|0.406||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698910|NCT01009554|3122152|Superiority or Other||Least Squares Mean Difference|0.256|Standard Error of the Mean|0.0544|<|0.001|2-Sided|95.0|0.148|0.364||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698911|NCT01009554|3122153|Superiority or Other||Least Squares Mean Difference|0.066|Standard Error of the Mean|0.0496||0.187|2-Sided|95.0|-0.033|0.165||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698912|NCT01009554|3122154|Superiority or Other||Least Squares Mean Difference|0.281|Standard Error of the Mean|0.0654|<|0.001|2-Sided|95.0|0.151|0.411||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698913|NCT01009554|3122155|Superiority or Other||Least Squares Mean Difference|0.262|Standard Error of the Mean|0.055|<|0.001|2-Sided|95.0|0.153|0.372||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698914|NCT01009554|3122156|Superiority or Other||Least Squares Mean Difference|0.062|Standard Error of the Mean|0.0491||0.21|2-Sided|95.0|-0.036|0.16||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698915|NCT01009554|3122157|Superiority or Other||Least Squares Mean Difference|0.567|Standard Error of the Mean|0.1367|<|0.001|2-Sided|95.0|0.295|0.839||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698916|NCT01009554|3122158|Superiority or Other||Least Squares Mean Difference|0.521|Standard Error of the Mean|0.112|<|0.001|2-Sided|95.0|0.298|0.743||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698917|NCT01009554|3122159|Superiority or Other||Least Squares Mean Difference|0.12|Standard Error of the Mean|0.1006||0.237|2-Sided|95.0|-0.08|0.32||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the lingual region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698918|NCT01009554|3122160|Superiority or Other||Least Squares Mean Difference|0.112|Standard Error of the Mean|0.0338||0.001|2-Sided|95.0|0.045|0.18||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698993|NCT01009086|3122246|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1698994|NCT01009086|3122247|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1698995|NCT01009086|3122247|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1698919|NCT01009554|3122161|Superiority or Other||Least Squares Mean Difference|0.016|Standard Error of the Mean|0.0224||0.486|2-Sided|95.0|-0.029|0.06||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698920|NCT01009554|3122162|Superiority or Other||Least Squares Mean Difference|0.002|Standard Error of the Mean|0.0179||0.93|2-Sided|95.0|-0.034|0.037||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698921|NCT01009554|3122163|Superiority or Other||Least Squares Mean Difference|0.102|Standard Error of the Mean|0.0309||0.001|2-Sided|95.0|0.04|0.163||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698922|NCT01009554|3122164|Superiority or Other||Least Squares Mean Difference|0.011|Standard Error of the Mean|0.0229||0.646|2-Sided|95.0|-0.035|0.056||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698923|NCT01009554|3122165|Superiority or Other||Least Squares Mean Difference|-0.002|Standard Error of the Mean|0.0187||0.914|2-Sided|95.0|-0.039|0.035||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698924|NCT01009554|3122166|Superiority or Other||Least Squares Mean Difference|0.222|Standard Error of the Mean|0.0693||0.002|2-Sided|95.0|0.084|0.359||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698925|NCT01009554|3122167|Superiority or Other||Least Squares Mean Difference|0.021|Standard Error of the Mean|0.0476||0.655|2-Sided|95.0|-0.073|0.116||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698926|NCT01009554|3122168|Superiority or Other||Least Squares Mean Difference|-0.005|Standard Error of the Mean|0.0384||0.893|2-Sided|95.0|-0.081|0.071||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the facial region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698927|NCT01009554|3122169|Superiority or Other||Least Squares Mean Difference|0.057|Standard Error of the Mean|0.0213||0.009|2-Sided|95.0|0.014|0.099||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698928|NCT01009554|3122170|Superiority or Other||Least Squares Mean Difference|0.024|Standard Error of the Mean|0.0186||0.192|2-Sided|95.0|-0.013|0.061||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698929|NCT01009554|3122171|Superiority or Other||Least Squares Mean Difference|-0.008|Standard Error of the Mean|0.016||0.623|2-Sided|95.0|-0.04|0.024||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698930|NCT01009554|3122172|Superiority or Other||Least Squares Mean Difference|0.049|Standard Error of the Mean|0.0196||0.014|2-Sided|95.0|0.01|0.088||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698931|NCT01009554|3122173|Superiority or Other||Least Squares Mean Difference|0.025|Standard Error of the Mean|0.0186||0.185|2-Sided|95.0|-0.012|0.062||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698932|NCT01009554|3122174|Superiority or Other||Least Squares Mean Difference|-0.014|Standard Error of the Mean|0.0145||0.348|2-Sided|95.0|-0.043|0.015||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698933|NCT01009554|3122175|Superiority or Other||Least Squares Mean Difference|0.116|Standard Error of the Mean|0.0439||0.01|2-Sided|95.0|0.028|0.203||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698934|NCT01009554|3122176|Superiority or Other||Least Squares Mean Difference|0.055|Standard Error of the Mean|0.0395||0.172|2-Sided|95.0|-0.024|0.133||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698935|NCT01009554|3122177|Superiority or Other||Least Squares Mean Difference|-0.02|Standard Error of the Mean|0.031||0.524|2-Sided|95.0|-0.082|0.042||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the body region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698936|NCT01009554|3122178|Superiority or Other||Least Squares Mean Difference|0.193|Standard Error of the Mean|0.0516|<|0.001|2-Sided|95.0|0.091|0.296||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698937|NCT01009554|3122179|Superiority or Other||Least Squares Mean Difference|0.168|Standard Error of the Mean|0.0398|<|0.001|2-Sided|95.0|0.089|0.247||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698938|NCT01009554|3122180|Superiority or Other||Least Squares Mean Difference|0.077|Standard Error of the Mean|0.0355||0.034|2-Sided|95.0|0.006|0.147||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698939|NCT01009554|3122181|Superiority or Other||Least Squares Mean Difference|0.197|Standard Error of the Mean|0.052|<|0.001|2-Sided|95.0|0.094|0.3||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698940|NCT01009554|3122182|Superiority or Other||Least Squares Mean Difference|0.178|Standard Error of the Mean|0.0415|<|0.001|2-Sided|95.0|0.095|0.26||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698941|NCT01009554|3122183|Superiority or Other||Least Squares Mean Difference|0.072|Standard Error of the Mean|0.0355||0.045|2-Sided|95.0|0.002|0.143||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698942|NCT01009554|3122184|Superiority or Other||Least Squares Mean Difference|0.394|Standard Error of the Mean|0.1095|<|0.001|2-Sided|95.0|0.176|0.612||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698943|NCT01009554|3122185|Superiority or Other||Least Squares Mean Difference|0.338|Standard Error of the Mean|0.087|<|0.001|2-Sided|95.0|0.165|0.51||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698944|NCT01009554|3122186|Superiority or Other||Least Squares Mean Difference|0.138|Standard Error of the Mean|0.0726||0.06|2-Sided|95.0|-0.006|0.282||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for the gingival region and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698945|NCT01009554|3122187|Superiority or Other||Least Squares Mean Difference|0.265|Standard Error of the Mean|0.0519|<|0.001|2-Sided|95.0|0.162|0.368||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698946|NCT01009554|3122188|Superiority or Other||Least Squares Mean Difference|0.177|Standard Error of the Mean|0.0414|<|0.001|2-Sided|95.0|0.095|0.259||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698947|NCT01009554|3122189|Superiority or Other||Least Squares Mean Difference|0.034|Standard Error of the Mean|0.0345||0.331|2-Sided|95.0|-0.035|0.102||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698962|NCT01009554|3122204|Superiority or Other||Least Squares Mean Difference|0.056|Standard Error of the Mean|0.0562||0.319|2-Sided|95.0|-0.055|0.168||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698948|NCT01009554|3122190|Superiority or Other||Least Squares Mean Difference|0.264|Standard Error of the Mean|0.0504|<|0.001|2-Sided|95.0|0.164|0.364||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698949|NCT01009554|3122191|Superiority or Other||Least Squares Mean Difference|0.174|Standard Error of the Mean|0.0414|<|0.001|2-Sided|95.0|0.092|0.256||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698950|NCT01009554|3122192|Superiority or Other||Least Squares Mean Difference|0.032|Standard Error of the Mean|0.0344||0.361|2-Sided|95.0|-0.037|0.1||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698951|NCT01009554|3122193|Superiority or Other||Least Squares Mean Difference|0.542|Standard Error of the Mean|0.1063|<|0.001|2-Sided|95.0|0.331|0.754||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698952|NCT01009554|3122194|Superiority or Other||Least Squares Mean Difference|0.349|Standard Error of the Mean|0.0843|<|0.001|2-Sided|95.0|0.182|0.517||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698953|NCT01009554|3122195|Superiority or Other||Least Squares Mean Difference|0.055|Standard Error of the Mean|0.0716||0.444|2-Sided|95.0|-0.087|0.197||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area score for interproximal (mesial and distal) sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698954|NCT01009554|3122196|Superiority or Other||Least Squares Mean Difference|0.195|Standard Error of the Mean|0.0406|<|0.001|2-Sided|95.0|0.114|0.276||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698955|NCT01009554|3122197|Superiority or Other||Least Squares Mean Difference|0.137|Standard Error of the Mean|0.032|<|0.001|2-Sided|95.0|0.073|0.2||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698956|NCT01009554|3122198|Superiority or Other||Least Squares Mean Difference|0.034|Standard Error of the Mean|0.0273||0.217|2-Sided|95.0|-0.02|0.088||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain area over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698957|NCT01009554|3122199|Superiority or Other||Least Squares Mean Difference|0.193|Standard Error of the Mean|0.0399|<|0.001|2-Sided|95.0|0.114|0.273||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698958|NCT01009554|3122200|Superiority or Other||Least Squares Mean Difference|0.137|Standard Error of the Mean|0.0324|<|0.001|2-Sided|95.0|0.073|0.202||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698959|NCT01009554|3122201|Superiority or Other||Least Squares Mean Difference|0.03|Standard Error of the Mean|0.0271||0.27|2-Sided|95.0|-0.024|0.084||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain intensity over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698960|NCT01009554|3122202|Superiority or Other||Least Squares Mean Difference|0.398|Standard Error of the Mean|0.084|<|0.001|2-Sided|95.0|0.231|0.565||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698961|NCT01009554|3122203|Superiority or Other||Least Squares Mean Difference|0.272|Standard Error of the Mean|0.0668|<|0.001|2-Sided|95.0|0.139|0.405||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline mean stain score over all tooth sites and smoking status as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698987|NCT01009099|3122244|Superiority or Other|||||||0.63|||||||ANCOVA|Co-variates included in the analysis were time walked on the constant workrate test at baseline and adherence (sessions completed/expected).||The outcomes compared were time walked on the constant workrate treadmill test measured in minutes.|
1698963|NCT01009554|3122205|Superiority or Other||Least Squares Mean Difference|-0.214|Standard Error of the Mean|0.0939||0.025|2-Sided|95.0|-0.401|-0.027||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698964|NCT01009554|3122206|Superiority or Other||Least Squares Mean Difference|-0.334|Standard Error of the Mean|0.0703|<|0.001|2-Sided|95.0|-0.474|-0.195||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698965|NCT01009554|3122207|Superiority or Other||Least Squares Mean Difference|-0.195|Standard Error of the Mean|0.0746||0.011|2-Sided|95.0|-0.343|-0.047||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value b and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698966|NCT01009554|3122208|Superiority or Other||Least Squares Mean Difference|-0.201|Standard Error of the Mean|0.1398||0.154|2-Sided|95.0|-0.479|0.077||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698967|NCT01009554|3122209|Superiority or Other||Least Squares Mean Difference|-0.161|Standard Error of the Mean|0.1386||0.249|2-Sided|95.0|-0.437|0.115||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698968|NCT01009554|3122210|Superiority or Other||Least Squares Mean Difference|0.041|Standard Error of the Mean|0.1235||0.741|2-Sided|95.0|-0.205|0.286||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter value L and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698969|NCT01009554|3122211|Superiority or Other||Least Squares Mean Difference|0.235|Standard Error of the Mean|0.0718||0.002|2-Sided|95.0|0.092|0.378||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698970|NCT01009554|3122212|Superiority or Other||Least Squares Mean Difference|0.006|Standard Error of the Mean|0.067||0.928|2-Sided|95.0|-0.127|0.139||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698971|NCT01009554|3122214|Superiority or Other||Least Squares Mean Difference|0.126|Standard Error of the Mean|0.0905||0.168|2-Sided|95.0|-0.054|0.306||The significance threshold level was 0.05 (two-sided).|ANCOVA|Terms included treatment as a factor and baseline tooth color parameter values (L, a, and b) and age (in years) as covariates.||The null hypothesis was no difference in mean outcome between treatment groups. The alternative hypothesis was a difference in mean outcome between treatment groups.|
1698972|NCT01009463|3122219|Superiority or Other||Least squares mean difference|0.064|||<|0.001|2-Sided|95.0|0.033|0.096||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1698973|NCT01009463|3122219|Superiority or Other||Least squares mean difference|0.058|||<|0.001|2-Sided|95.0|0.027|0.09||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1698974|NCT01009463|3122219|Superiority or Other||Least squares mean difference|0.041|||<|0.011|2-Sided|95.0|0.009|0.072||Nominal p-value|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|||
1698975|NCT01009463|3122220|Superiority or Other||Risk Ratio (RR)|0.81||||0.064|2-Sided|95.0|0.64|1.01|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable|||
1698976|NCT01009463|3122220|Superiority or Other||Risk Ratio (RR)|0.62|||<|0.001|2-Sided|95.0|0.49|0.78||Nominal p-value|Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable|||
1698977|NCT01009463|3122220|Superiority or Other||Risk Ratio (RR)|0.84|||<|0.125|2-Sided|95.0|0.67|1.05|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.|||
1698978|NCT01009463|3122221|Superiority or Other||Hazard Ratio (HR)|0.85||||0.114|2-Sided|95.0|0.69|1.04|||Regression, Cox||||
1698979|NCT01009463|3122221|Superiority or Other||Hazard Ratio (HR)|0.72||||0.002|2-Sided|95.0|0.59|0.89||Nominal p-value|Regression, Cox||||
1698980|NCT01009463|3122221|Superiority or Other||Hazard Ratio (HR)|0.92||||0.43|2-Sided|95.0|0.76|1.13|||Regression, Cox||||
1698981|NCT01009463|3122222|Superiority or Other||Risk Ratio (RR)|0.85||||0.109|2-Sided|95.0|0.7|1.04|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.|||
1698982|NCT01009463|3122222|Superiority or Other||Risk Ratio (RR)|0.66|||<|0.001|2-Sided|95.0|0.54|0.81||Nominal p-value|Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.|||
1698983|NCT01009463|3122222|Superiority or Other||Risk Ratio (RR)|0.87|||<|0.181|2-Sided|95.0|0.72|1.06|||Generalized Linear Model|Assuming Negative Binomial distribution with logarithm of time on treatment as an offset variable.|||
1698984|NCT01009333|3122225|Superiority or Other|||||||0.04|||||||Mixed Models Analysis||||
1698985|NCT01009333|3122226|Superiority or Other|||||||0.589|||||||Mixed Models Analysis||||
1698986|NCT01009333|3122227|Superiority or Other|||||||0.008|||||||Mixed Models Analysis||||
1698996|NCT01009086|3122247|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1698997|NCT01009086|3122248|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1698998|NCT01009086|3122248|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1698999|NCT01009086|3122248|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1699000|NCT01009086|3122249|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1699001|NCT01009086|3122249|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1699002|NCT01009086|3122249|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1699003|NCT01009086|3122250|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1699004|NCT01009086|3122250|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1699005|NCT01009086|3122250|Superiority or Other||||||<|0.001|||||||re-randomization test||||
1699006|NCT01009060|3122259|Superiority or Other||Mean Difference (Net)|1.824||||0.4637|2-Sided|90.0|-2.334|5.982|||Mixed Model Repeated Measure||||
1699007|NCT01009060|3122260|Superiority or Other||Mean Difference (Net)|-1.876||||0.5197|2-Sided|90.0|-6.743|2.99|||Mixed Model Repeated Measure||||
1699008|NCT01009060|3122261|Superiority or Other||Mean Difference (Net)|-1.024||||0.4406|2-Sided|90.0|-3.237|1.19|||Mixed Model Repeated Measure||||
1699009|NCT01009060|3122262|Superiority or Other||Mean Difference (Net)|-0.338||||0.9092|2-Sided|90.0|-5.316|4.639|||ANCOVA||For Social Cognition||
1699010|NCT01009060|3122262|Superiority or Other||Mean Difference (Net)|0.972||||0.6582|2-Sided|90.0|-2.709|4.654|||ANCOVA||For Reasoning and Problem Solving||
1699011|NCT01009060|3122262|Superiority or Other||Mean Difference (Net)|3.112||||0.1585|2-Sided|90.0|-0.537|6.761|||ANCOVA||For Verbal Learning||
1699012|NCT01009060|3122262|Superiority or Other||Mean Difference (Net)|-0.746||||0.7497|2-Sided|90.0|-4.667|3.175|||ANCOVA||For Visual Learning||
1699013|NCT01009060|3122262|Superiority or Other||Mean Difference (Net)|-2.038||||0.3243|2-Sided|90.0|-5.482|1.406|||ANCOVA||For Working Memory||
1699014|NCT01009060|3122262|Superiority or Other||Mean Difference (Net)|-2.24||||0.3317|2-Sided|95.0|-6.085|1.605|||ANCOVA||For Attention/Vigilance||
1699015|NCT01009060|3122262|Superiority or Other||Mean Difference (Net)|-4.024||||0.0225|2-Sided|90.0|-6.872|-1.175|||ANCOVA||For Speed of Processing||
1699016|NCT01009060|3122263|Superiority or Other||Mean Difference (Net)|0.069||||0.7873|2-Sided|90.0|-0.364|0.503|||Mixed Model Repeated Measure||For Working Memory (Two-Back Memory)||
1699017|NCT01009060|3122263|Superiority or Other||Mean Difference (Net)|0.03||||0.8645|2-Sided|90.0|-0.262|0.322|||Mixed Model Repeated Measure||For Social Cognition||
1699018|NCT01009060|3122263|Superiority or Other||Mean Difference (Net)|0.177||||0.2069|2-Sided|90.0|-0.055|0.409|||Mixed Model Repeated Measure||For Reasoning/Problem Solving||
1699019|NCT01009060|3122263|Superiority or Other||Mean Difference (Net)|0.398||||0.2417|2-Sided|90.0|-0.167|0.963|||Mixed Model Repeated Measure||For Verbal Learning||
1699020|NCT01009060|3122263|Superiority or Other||Mean Difference (Net)|0.279||||0.2531|2-Sided|90.0|-0.127|0.685|||Mixed Model Repeated Measure||For Visual Learning||
1699021|NCT01009060|3122263|Superiority or Other||Mean Difference (Net)|0.391||||0.1547|2-Sided|90.0|-0.063|0.845|||Mixed Model Repeated Measure||For Working Memory||
1699022|NCT01009060|3122263|Superiority or Other||Mean Difference (Net)|0.179||||0.3992|2-Sided|90.0|-0.176|0.534|||Mixed Model Repeated Measure||For Attention/Vigilance||
1699023|NCT01009060|3122263|Superiority or Other||Mean Difference (Net)|-0.252||||0.1399|2-Sided|90.0|-0.535|0.03|||Mixed Model Repeated Measure||For Speed of Processing/Simple Reaction Time||
1699024|NCT01009060|3122264|Superiority or Other||Mean Difference (Net)|-0.737||||0.6947|2-Sided|90.0|-3.884|2.409|||ANCOVA||||
1699025|NCT01009060|3122265|Superiority or Other||Mean Difference (Net)|0.103||||0.4778|2-Sided|90.0|-0.139|0.344|||Mixed Model Repeated Measure|||Week 7|
1699026|NCT01009060|3122265|Superiority or Other||Mean Difference (Net)|0.195||||0.2594|2-Sided|90.0|-0.093|0.484|||Mixed Model Repeated Measure|||Week 6|
1699027|NCT01009060|3122265|Superiority or Other||Mean Difference (Net)|0.086||||0.3887|2-Sided|90.0|-0.082|0.254|||Mixed Model Repeated Measure|||Week 5|
1699028|NCT01009060|3122265|Superiority or Other||Mean Difference (Net)|-0.089||||0.4148|2-Sided|90.0|-0.272|0.093|||Mixed Model Repeated Measure|||Week 4|
1699029|NCT01009060|3122265|Superiority or Other||Mean Difference (Net)|-0.088||||0.4541|2-Sided|90.0|-0.287|0.11|||Mixed Model Repeated Measure|||Week 3|
1699030|NCT01009060|3122265|Superiority or Other||Mean Difference (Net)|0.018||||0.8351|2-Sided|90.0|-0.127|0.163|||Mixed Model Repeated Measure|||Week 2|
1699031|NCT01009060|3122265|Superiority or Other||Mean Difference (Net)|-0.049||||0.7239|2-Sided|90.0|-0.288|0.19|||Mixed Model Repeated Measure|||Week 1|
1699032|NCT01009047|3122266|Superiority or Other|||||||0.444||||||Day 182: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.|Cochran-Mantel-Haenszel||||
1699033|NCT01009047|3122266|Superiority or Other|||||||0.119||||||Day 56: Generalized Cochran-Mantel-Haenszel test for row mean score differences was used.|Cochran-Mantel-Haenszel||||
1699034|NCT01009047|3122267|Superiority or Other||LS mean difference|0.6|Standard Error of the Mean|1.66||0.705|2-Sided|95.0|-2.64|3.89||Change at Day 182: Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA||||
1699035|NCT01009047|3122267|Superiority or Other||LS mean difference|0.2|Standard Error of the Mean|1.27||0.895|2-Sided|95.0|-2.34|2.67||Change at Day 56: Analysis of covariance (ANCOVA) model with treatment groups(paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA||||
1699036|NCT01009047|3122268|Superiority or Other|||||||0.914||||||Change at Day 182: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.|ANCOVA||||
1699037|NCT01009047|3122268|Superiority or Other|||||||0.843||||||Change at Day 56: ANCOVA model on ranks with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value (unranked) as a covariate was used.|ANCOVA||||
1699038|NCT01009047|3122269|Superiority or Other|||||||0.296||||||Generalized Cochran- Mantel- Haenszel test for row mean score differences controlling for country was used.|Cochran-Mantel-Haenszel||||
1699039|NCT01009047|3122271|Superiority or Other|||||||0.745||||||Change at Day 182: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA||||
1699040|NCT01009047|3122271|Superiority or Other|||||||0.803||||||Change at Day 56: Anxiety/ depression - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA||||
1699041|NCT01009047|3122271|Superiority or Other|||||||0.985||||||Change at Day 182: Uncontrolled Hositility/ Excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA||||
1699042|NCT01009047|3122271|Superiority or Other|||||||0.984||||||Change at Day 56: Uncontrolled hostility/ excitement - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA||||
1699043|NCT01009047|3122271|Superiority or Other|||||||0.766||||||Change at Day 182: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA||||
1699044|NCT01009047|3122271|Superiority or Other|||||||0.965||||||Change at Day 56: Disorganized thoughts - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA||||
1699045|NCT01009047|3122271|Superiority or Other|||||||0.691||||||Change at Day 182:Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA||||
1699046|NCT01009047|3122271|Superiority or Other|||||||0.351||||||Change at Day 56: Positive Symptoms - ANCOVA model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate.|ANCOVA||||
1699047|NCT01009047|3122272|Superiority or Other||LS mean difference|0.2|Standard Error of the Mean|0.66||0.723|2-Sided|95.0|-1.06|1.53||Day 182: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA||||
1699048|NCT01009047|3122272|Superiority or Other||LS mean difference|0.5|Standard Error of the Mean|0.54||0.341|2-Sided|95.0|-0.55|1.59||Day 56: Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA||||
1699049|NCT01009047|3122273|Superiority or Other||LS mean difference|-0.3|Standard Error of the Mean|2.2||0.877|2-Sided|95.0|-4.68|4.0||Analysis of covariance (ANCOVA) model with treatment groups (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA||||
1699050|NCT01009047|3122274|Superiority or Other||Least-squares (LS) mean difference|0.1|Standard Error of the Mean|1.83||0.935|2-Sided|95.0|-3.46|3.76||Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used.|ANCOVA||||
1699051|NCT01008995|3122278|Superiority or Other||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 65kg vs > 65 kg) as factors in the model.||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.|
1699052|NCT01008995|3122279|Superiority or Other||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel|Stratified by baseline weight [≤ 65kg vs > 65 kg)].||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.|
1699053|NCT01008995|3122280|Superiority or Other||||||<|0.001||||||The study was designed to maintain a Type I error of 0.05 or less for the primary analysis.|Cochran-Mantel-Haenszel|Stratified by baseline weight [≤ 65kg vs > 65 kg)].||Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. Power calculations were based on two sample size assumptions: 220 (1:1 ratio) and 320 participants (1:1 ratio). Simulation studies evaluated the power to detect a treatment difference between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight [<=65 kg vs > 65 kg). The power was >99% for both sample size assumptions.|
1699054|NCT01008696|3122300|Superiority or Other|||||||0.5032|||||||Wilcoxon rank-sum test||||
1699055|NCT01008696|3122301|Superiority or Other|||||||0.531||||||Change at Day 57: Belching|Wilcoxon rank-sum test||||
1699056|NCT01008696|3122301|Superiority or Other|||||||0.3654||||||Change at Day 57: Vomitting|Wilcoxon rank-sum test||||
1699057|NCT01008696|3122301|Superiority or Other|||||||0.7047||||||Change at Day 57: Nausea|Wilcoxon rank-sum test||||
1699058|NCT01008696|3122301|Superiority or Other|||||||0.5566||||||Change at Day 57: Early satiety|Wilcoxon rank-sum test||||
1699059|NCT01008696|3122301|Superiority or Other|||||||0.5913||||||Change at Day 57: Post-prandial discomfort|Wilcoxon rank-sum test||||
1699060|NCT01008696|3122301|Superiority or Other|||||||0.568||||||Change at Day 57: Bloating|Wilcoxon rank-sum test||||
1699061|NCT01008696|3122301|Superiority or Other|||||||0.8068||||||Change at Day 57: Abdominal distension|Wilcoxon rank-sum test||||
1699062|NCT01008696|3122301|Superiority or Other|||||||0.5335||||||Change at Day 57: Dysphagia|Wilcoxon rank-sum test||||
1699063|NCT01008696|3122301|Superiority or Other|||||||0.6295||||||Change at Day 57: Hoarseness|Wilcoxon rank-sum test||||
1699064|NCT01008696|3122301|Superiority or Other|||||||0.2776||||||Change at Day 57: Non cardiac chest pain|Wilcoxon rank-sum test||||
1699065|NCT01008696|3122301|Superiority or Other|||||||0.9874||||||Change at Day 57: Epigastric pain|Wilcoxon rank-sum test||||
1699066|NCT01008696|3122301|Superiority or Other|||||||0.8294||||||Change at Day 57: Chronic cough|Wilcoxon rank-sum test||||
1699067|NCT01008696|3122301|Superiority or Other|||||||0.7809||||||Change at Day 57: Globus sensation|Wilcoxon rank-sum test||||
1699068|NCT01008696|3122301|Superiority or Other|||||||0.6414||||||Change at Day 57: Regurgitation|Wilcoxon rank-sum test||||
1699069|NCT01008696|3122301|Superiority or Other|||||||0.7734||||||Change at Day 57: Heartburn|Wilcoxon rank-sum test||||
1699070|NCT01008696|3122302|Superiority or Other|||||||0.266||||||Poor metabolizer|Chi-squared||||
1699071|NCT01008696|3122302|Superiority or Other|||||||0.865||||||Heterozygous extensive metabolizer|Chi-squared||||
1699226|NCT01005680|3122705|Superiority or Other|||||||0.451|||||||two-sided Z test||||
1699072|NCT01008696|3122302|Superiority or Other|||||||0.8849||||||Homozygous extensive metabolizer|Chi-squared||||
1699073|NCT01008618|3122315|Superiority or Other|||||||0.0846|||||||Log Rank||||
1699074|NCT01008605|3122322|Superiority or Other||Lower limit, 95% one-sided CI|95.83|||||1-Sided|95.0|87.46||||||||
1699075|NCT01008553|3122335|Superiority or Other|||||||0.0003|||||||Log Rank||||
1699076|NCT01008475|3122336|Superiority or Other||Cox Proportional Hazard|1.05|||||2-Sided|95.0|0.74|1.48|||||||
1699077|NCT01008475|3122336|Superiority or Other||Cox Proportional Hazard|0.95|||||2-Sided|95.0|0.67|1.34|||||||
1699078|NCT01008475|3122338|Superiority or Other||Cox Proportional Hazard|1.11|||||2-Sided|95.0|0.75|1.65|||||||
1699079|NCT01008475|3122338|Superiority or Other||Cox Proportional Hazard|1.11|||||2-Sided|95.0|0.75|1.65|||||||
1699080|NCT01008475|3122339|Superiority or Other||Cox Proportional Hazard|0.8|||||2-Sided|95.0|0.52|1.25|||||||
1699081|NCT01008475|3122339|Superiority or Other||Cox Proportional Hazard|0.83|||||2-Sided|95.0|0.54|1.28|||||||
1699082|NCT01008475|3122340|Superiority or Other||Cox Proportional Hazard|1.11|||||2-Sided|95.0|0.77|1.61|||||||
1699083|NCT01008475|3122340|Superiority or Other||Cox Proportional Hazard|1.13|||||2-Sided|95.0|0.78|1.64|||||||
1699084|NCT01008423|3122366|Superiority||||||<|0.0001||||||Threshold for significance at 0.05 level.|Regression, Logistic|||The logistic regression test was used to test for a difference in the percentages between the 2 treatment arms after adjusting for analysis center (country).|
1699085|NCT01008410|3122376|Superiority|||||||0.0324||||||Threshold for significance at 0.05 level.|Regression, Logistic|||The logistic regression test was used to test for a difference in the percentages between the 2 treatment arms after adjusting for analysis center (country).|
1699086|NCT01008280|3122380|Superiority or Other||||||>|0.01|||||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of heavy drinking days.|
1699087|NCT01008280|3122380|Superiority or Other||||||>|0.01|||||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of heavy drinking days.|
1699088|NCT01008280|3122380|Superiority or Other||||||<|0.01|||||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of heavy drinking days.|
1699089|NCT01008280|3122381|Superiority or Other||||||>|0.01|||||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group by time effects for the number of drinks.|
1699090|NCT01008280|3122381|Superiority or Other||||||>|0.01|||||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinks.|
1699091|NCT01008280|3122381|Superiority or Other||||||<|0.01|||||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinks.|
1699092|NCT01008280|3122382|Superiority or Other||||||>|0.01|||||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time by group effects for the number of drinking days.|
1699093|NCT01008280|3122382|Superiority or Other||||||>|0.01|||||||Wald Chi-Squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed group effects for the number of drinking days.|
1699094|NCT01008280|3122382|Superiority or Other||||||<|0.01|||||||Wald Chi-squared|||This was an intent to treat analysis where Generalized Estimating Equations, using the Negative Binomial function, were used to test for group, time, and group by time effects for drinks, drinking days, and heavy drinking days. This analysis assessed time effects for the number of drinking days.|
1699095|NCT01008059|3122389|Superiority||||||<|0.05|||||||ANOVA||||
1699096|NCT01007942|3122399|Superiority or Other||Hazard Ratio (HR)|0.78||||0.0067|2-Sided|95.0|0.65|0.95|||Log Rank||||
1699097|NCT01007838|3122401|Superiority or Other|||||||0.024||||||Statistical sigficance was accepted if p < 0.05.|ANOVA|||Follow up ANOVA in healthy controls only. An interaction would suggest healthy controls allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.|
1699098|NCT01007838|3122401|Superiority or Other|||||||0.0017||||||Statistical significance was accepted if p < 0.05.|ANOVA|||Follow up ANOVA in chronic kideny disease patients only. An interaction would suggest patients allocated to the resistance exercise group increased muscle size more than those allocated to the sham exercise group.|
1699099|NCT01007838|3122401|Superiority or Other|||||||0.3||||||Statistical significance was accepted if p < 0.05.|ANCOVA|||Omnibus ANCOVA. An interaction would suggests patients responded to exercise differently than controls|
1699100|NCT01007591|3122427|Superiority||Mean Difference (Final Values)|-6.02||||0.75|2-Sided|95.0|-43.7|31.7|||ANOVA|Treatment comparison using an ANOVA model with age group and treatment as design variables.|||
1699135|NCT01006616|3122563|Superiority or Other||Mean Difference (Net)|-0.029||||0.37|2-Sided|95.0|-0.091|0.034|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and ICS use (yes/no)|||
1699282|NCT01002339|3123080|Superiority or Other|||||||0.02|||||||Chi-squared||||
1702225|NCT00955201|3130412|Superiority|||||||0.5|||||||ANOVA|||Comparison across groups at 12-wks.|
1699101|NCT01007435|3122457|Superiority or Other||Odds Ratio (OR)|2.72|||<|0.0001|2-Sided|95.0|1.8|4.11||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons. This comparison came after the break in statistical hierarchy.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to “non-responder”.|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 4 mg/kg + methotrexate treatment groups.|
1699102|NCT01007435|3122457|Superiority or Other||Odds Ratio (OR)|3.7|||<|0.0001|2-Sided|95.0|2.47|5.55||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to “non-responder”.|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + placebo to methotrexate treatment groups.|
1699103|NCT01007435|3122457|Superiority or Other||Odds Ratio (OR)|4.77|||<|0.0001|2-Sided|95.0|3.19|7.14||A hierarchy of statistical testing was implemented in order to control the type I error rate for multiple comparisons.|Regression, Logistic|The stratification factors, region and serologic status, were included in the model.|Last observation carried forward was used for TJC and SJC. No imputation was used for ESR and GH. Patients who withdrew prematurely or where a DAS28 could not be calculated were set to “non-responder”.|The null hypothesis is that there is no difference in the DAS28 remission response at Week 24 between the placebo to tocilizumab + methotrexate and the tocilizumab 8 mg/kg + methotrexate treatment groups.|
1699104|NCT01007253|3122461|Superiority or Other||||||<|0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean tryptase level difference among the four treatment groups.|
1699105|NCT01007253|3122462|Superiority or Other|||||||0.11|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean histamine level difference among the four treatment groups.|
1699106|NCT01007253|3122463|Superiority or Other|||||||0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean sneeze difference among the four treatment groups.|
1699107|NCT01007253|3122464|Superiority or Other|||||||0.05|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean nasal symptoms score difference among the four treatment groups.|
1699108|NCT01007253|3122465|Superiority or Other||||||<|0.001|||||||Friedman ANOVA|||Analysis of variance (ANOVA) was used to test the null hypothesis of no mean eye symptoms score difference among the four treatment groups.|
1699109|NCT01007123|3122475|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1699110|NCT01007123|3122475|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1699111|NCT01007123|3122475|Superiority or Other||||||<|0.17|||||||ANCOVA||||
1699112|NCT01007123|3122476|Superiority or Other||||||<|0.05|||||||ANCOVA|||Comparison vs placebo|
1699113|NCT01007123|3122476|Superiority or Other||||||<|0.01|||||||ANCOVA|||Comparison vs placebo|
1699114|NCT01007123|3122477|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1699115|NCT01007123|3122477|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1699116|NCT01007123|3122477|Superiority or Other||||||<|0.44|||||||ANCOVA||||
1699117|NCT01007123|3122478|Superiority or Other|||||||0.04|||||||Fisher Exact||||
1699118|NCT01007123|3122478|Superiority or Other|||||||0.03|||||||Fisher Exact||||
1699119|NCT01007123|3122478|Superiority or Other|||||||0.06|||||||Fisher Exact||||
1699120|NCT01007123|3122479|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1699121|NCT01007123|3122479|Superiority or Other||||||<|0.008|||||||Fisher Exact||||
1699122|NCT01007123|3122479|Superiority or Other||||||<|0.03|||||||Fisher Exact||||
1699123|NCT01007123|3122480|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1699124|NCT01007123|3122480|Superiority or Other||||||<|0.002|||||||ANCOVA||||
1699125|NCT01007123|3122480|Superiority or Other||||||<|0.2|||||||ANCOVA||||
1699126|NCT01006980|3122503|Superiority or Other||Hazard Ratio (HR)|0.26|||<|0.0001|2-Sided|95.0|0.2|0.33|||Log Rank||Hazard ratios for treatment with vemurafenib, as compared with dacarbazine, were estimated with the use of unstratified Cox regression.|The trial had a power of 90% to detect a hazard ratio of 0.55 for progression-free survival with an alpha level of 0.005 (an increase in median survival from 2.5 months for dacarbazine to 4.5 months for vemurafenib).|
1699127|NCT01006980|3122504|Superiority or Other||Hazard Ratio (HR)|0.37|||<|0.0001|2-Sided|95.0|0.26|0.55|||Log Rank||The hazard ratio for death for vemurafenib relative to dacarbazine and the associated 95% confidence interval were computed using an unstratified Cox regression model.|The trial had a power of 80% to detect a hazard ratio of 0.65 for overall survival with an alpha level of 0.045 (an increase in median survival from 8 months for dacarbazine to 12.3 months for vemurafenib), one interim analysis for overall survival at 50% information.|
1699128|NCT01006707|3122519|Superiority or Other|||||||0.261|||||||ANOVA|||Results were considered significant at p<0.05.|
1699129|NCT01006707|3122520|Superiority or Other|||||||0.322|||||||ANOVA|||Results were considered significant at p<0.05.|
1699130|NCT01006707|3122521|Superiority or Other|||||||0.042|||||||ANOVA|||Results were considered significant at p<0.05.|
1699131|NCT01006616|3122562|Superiority or Other||Difference in percentages|19.7|||<|0.001|2-Sided|95.0|13.8|26.9|||Miettinen and Nurminen||Analysis of Week 26 data||
1699132|NCT01006616|3122562|Superiority or Other||Difference in percentages|12.2|||<|0.001|2-Sided|95.0|7.4|18.4|||Miettinen and Nurminen||Analysis of Week 26 data||
1699133|NCT01006616|3122562|Superiority or Other||Difference in percentages|2.6|||<|0.096|2-Sided|95.0|-0.6|6.9|||Miettinen and Nurminen||Analysis of Week 26 data||
1699134|NCT01006616|3122563|Superiority or Other||Mean Difference (Net)|0.067||||0.037|2-Sided|95.0|0.004|0.131|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and ICS use (yes/no)|||
1699136|NCT01006616|3122563|Superiority or Other||Mean Difference (Net)|0.031||||0.325|2-Sided|95.0|-0.03|0.091|||Constrained Longitudinal Data Analysis|Model with treatment, time, treatment by time interaction, and baseline smoking status (yes/no) and inhaled corticosteroid (ICS) use (yes/no)|||
1699137|NCT01006590|3122571|Superiority or Other||Mean Difference (Net)|2.39|Standard Error of the Mean|4.34||0.5882|2-Sided|95.0|-6.22|10.93|||ANCOVA||||
1699138|NCT01006590|3122572|Superiority or Other||Mean Difference (Net)|0.3|Standard Error of the Mean|1.19||0.7701|2-Sided|95.0|-2.0|2.7|||ANCOVA||||
1699139|NCT01006590|3122573|Superiority or Other||Mean Difference (Net)|0.07|Standard Error of the Mean|0.23||0.7627|2-Sided|95.0|-0.38|0.52|||ANCOVA||||
1699140|NCT01006590|3122574|Superiority or Other||Mean Difference (Net)|2.3|Standard Error of the Mean|4.58||0.6203|2-Sided|95.0|-6.7|11.3|||Regression, Logistic||||
1699141|NCT01006590|3122575|Superiority or Other||Mean Difference (Net)|5.8|Standard Error of the Mean|5.79||0.3202|2-Sided|95.0|-5.6|17.1|||Regression, Logistic||||
1699142|NCT01006590|3122576|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.09||0.26|2-Sided|95.0|-0.26|0.07|||ANCOVA|With baseline value as covariate and treatment group as factor; comparison of LSmeans for treatment||The null hypothesis H0: µt-µC=0, where μT denotes the mean absolute change in HbA1c from baseline to Week 24 in the group of patients treated with saxagliptin (test medication, T) and μC the mean absolute change in HbA1c from baseline to Week 24 in the group of patients with uptitration of metformin (comparator, C) A sample size of 120 randomized and treated patients per treatment group yielded 80% power under the assumption of a true treatment difference of 0.4% and a standard deviation of 1.1%|
1699143|NCT01006252|3122600|Superiority or Other|||||||0.414||||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.|||
1699144|NCT01006252|3122600|Superiority or Other|||||||0.547||||||P-value given for Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.|||
1699145|NCT01006252|3122602|Superiority or Other|||||||0.414||||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.|||
1699146|NCT01006252|3122602|Superiority or Other|||||||0.547||||||P-value given for Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.|||
1699147|NCT01006252|3122603|Superiority or Other|||||||0.97||||||P-value given for Overall Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.|||
1699148|NCT01006252|3122603|Superiority or Other|||||||0.902||||||P-value given for Overall Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.|||
1699149|NCT01006252|3122605|Superiority or Other|||||||0.97||||||P-value given for Treatment-By-Cycle Interaction from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.|||
1699150|NCT01006252|3122605|Superiority or Other|||||||0.902||||||P-value given for Overall Main Treatment Effect from the repeated measure model where time was a class variable. Statistical significance was assessed at an alpha level of 0.05.|Mixed Model Repeated Measures (MMRM)|MMRM analyses limited to first 4 cycles due to sparse data; data from 30-day follow-up visit coded to first cycle after last on-treatment cycle.|||
1699151|NCT01006252|3122606|Superiority or Other||Hazard Ratio (HR)|1.11||||0.505||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank||||
1699152|NCT01006252|3122607|Superiority or Other|||||||0.483||||||Statistical significance was assessed at an alpha level of 0.05.|Unadjusted normal distribution|Unadjusted normal-distribution approximation for the difference in rates.|||
1699153|NCT01006252|3122609|Superiority or Other|||||||0.396||||||Statistical significance was assessed at an alpha level of 0.05.|Unadjusted normal distribution|Unadjusted normal-distribution approximation for the difference in rates|||
1699154|NCT01006252|3122610|Superiority or Other||Hazard Ratio (HR)|1.3||||0.048||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank|Analysis adjusted for Baseline Lactate Dehydrogenase (LDH); Disease Stage; Sex; Previous Single Agent Immunotherapy Treatment; Age Group|||
1699155|NCT01006252|3122611|Superiority or Other||Hazard Ratio (HR)|1.23||||0.121||95.0||||Statistical significance was assessed at an alpha level of 0.05.|Stratified log rank||||
1699156|NCT01006122|3122627|Superiority or Other||LS Means Difference|0.02|Standard Error of the Mean|0.156||0.541|2-Sided|80.0|-0.18|0.22|||Mixed Models Analysis|||Day 21 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.|
1699157|NCT01006122|3122627|Superiority or Other||LS Means Difference|-0.15|Standard Error of the Mean|0.147||0.16|2-Sided|80.0|-0.34|0.04|||Mixed Models Analysis|||Day 14 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.|
1699527|NCT00999167|3123630|Superiority or Other|||||||0.252|||||||ANCOVA|||Changes in the Total Index Score from Baseline and the Final Visit.|
1699158|NCT01006122|3122627|Superiority or Other||LS Means Difference|0.05|Standard Error of the Mean|0.148||0.631|2-Sided|80.0|-0.14|0.24|||Mixed Models Analysis|||Day 7 (SP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.|
1699159|NCT01006122|3122627|Superiority or Other||LS Means Difference|0.16|Standard Error of the Mean|0.152||0.85|2-Sided|80.0|-0.04|0.35|||Mixed Models Analysis|||Day 20 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.|
1699160|NCT01006122|3122627|Superiority or Other||LS Means Difference|0.09|Standard Error of the Mean|0.143||0.738|2-Sided|80.0|-0.09|0.27|||Mixed Models Analysis|||Day 15 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.|
1699161|NCT01006122|3122627|Superiority or Other||LS Means Difference|-0.07|Standard Error of the Mean|0.141||0.303|2-Sided|80.0|-0.25|0.11|||Mixed Models Analysis|||Day 10 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.|
1699162|NCT01006122|3122627|Superiority or Other||LS Means Difference|-0.16|Standard Error of the Mean|0.142||0.127|2-Sided|80.0|-0.34|0.02|||Mixed Models Analysis|||Day 5 (TP), One-sided p-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects and participant as random effect.|
1699163|NCT01006122|3122630|Superiority or Other||LS Means Difference|0.14|Standard Error of the Mean|0.266||0.698|2-Sided|80.0|-0.2|0.48|||Mixed Models Analysis|||Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.|
1699164|NCT01006122|3122630|Superiority or Other||LS Means Difference|0.18|Standard Error of the Mean|0.253||0.767|2-Sided|80.0|-0.14|0.51|||Mixed Models Analysis|||Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.|
1699165|NCT01006122|3122630|Superiority or Other||LS Means Difference|0.14|Standard Error of the Mean|0.253||0.711|2-Sided|80.0|-0.18|0.46|||Mixed Models Analysis|||Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.|
1699166|NCT01006122|3122630|Superiority or Other||LS Means Difference|0.0|Standard Error of the Mean|0.26||0.495|2-Sided|80.0|-0.34|0.33|||Mixed Models Analysis|||Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.|
1699167|NCT01006122|3122630|Superiority or Other||LS Means Difference|-0.36|Standard Error of the Mean|0.244||0.073|2-Sided|80.0|-0.67|-0.04|||Mixed Models Analysis|||Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.|
1699168|NCT01006122|3122630|Superiority or Other||LS Means Difference|-0.07|Standard Error of the Mean|0.243||0.394|2-Sided|80.0|-0.38|0.25|||Mixed Models Analysis|||Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.|
1699169|NCT01006122|3122630|Superiority or Other||LS Means Difference|-0.29|Standard Error of the Mean|0.244||0.121|2-Sided|80.0|-0.6|0.03|||Mixed Models Analysis|||Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline global score as a covariate and participant as random effect.|
1699170|NCT01006122|3122631|Superiority or Other||LS Means Difference|-0.3|Standard Error of the Mean|0.498||0.274|2-Sided|80.0|-0.94|0.34|||Mixed Models Analysis|||Day 21 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.|
1699171|NCT01006122|3122631|Superiority or Other||LS Means Difference|-0.63|Standard Error of the Mean|0.473||0.093|2-Sided|80.0|-1.23|-0.02|||Mixed Models Analysis|||Day 14 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.|
1699172|NCT01006122|3122631|Superiority or Other||LS Means Difference|-0.35|Standard Error of the Mean|0.473||0.232|2-Sided|80.0|-0.95|0.26|||Mixed Models Analysis|||Day 7 (SP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.|
1699173|NCT01006122|3122631|Superiority or Other||LS Means Difference|0.13|Standard Error of the Mean|0.487||0.604|2-Sided|80.0|-0.5|0.75|||Mixed Models Analysis|||Day 20 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.|
1699174|NCT01006122|3122631|Superiority or Other||LS Means Difference|-0.6|Standard Error of the Mean|0.457||0.095|2-Sided|80.0|-1.19|-0.01|||Mixed Models Analysis|||Day 15 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.|
1699175|NCT01006122|3122631|Superiority or Other||LS Means Difference|-0.31|Standard Error of the Mean|0.453||0.247|2-Sided|80.0|-0.89|0.27|||Mixed Models Analysis|||Day 10 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.|
1699176|NCT01006122|3122631|Superiority or Other||LS Means Difference|-0.73|Standard Error of the Mean|0.457||0.054|2-Sided|80.0|-1.32|-0.15|||Mixed Models Analysis|||Day 5 (TP), P-value was based on linear mixed effects model with treatment, period, time and treatment by time interaction as fixed effects, baseline total score as a covariate and participant as random effect.|
1699223|NCT01005719|3122700|Superiority or Other|||||||0.027||||||p-value for 15-20 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values <= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)||||
1699177|NCT01006122|3122632|Superiority or Other||Least Squares (LS) Mean Difference|0.16|Standard Error of the Mean|0.747||0.418|2-Sided|80.0|-0.81|1.12|||Mixed Models Analysis|||One sided p-value was based on linear mixed effects model with treatment and period as fixed effects, baseline MWT as a covariate and participant as random effect.|
1699178|NCT01005966|3122634|Superiority or Other||Adjusted Mean Difference|1186.49|||<|0.0001|2-Sided|95.0|915.38|1457.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.|
1699179|NCT01005966|3122634|Superiority or Other||Adjusted Mean Difference|1346.79|||<|0.0001|2-Sided|95.0|1076.46|1617.11||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.|
1699180|NCT01005966|3122634|Superiority or Other||Adjusted Mean Difference|160.3|||<|0.2448|2-Sided|95.0|-110.58|431.18||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.|
1699181|NCT01005966|3122634|Superiority or Other||Adjusted Mean Difference|1842.16|||<|0.0001|2-Sided|95.0|1568.73|2115.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.|
1699182|NCT01005966|3122634|Superiority or Other||Adjusted Mean Difference|655.67|||<|0.0001|2-Sided|95.0|382.41|928.93||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.|
1699183|NCT01005966|3122634|Superiority or Other||Adjusted Mean Difference|495.38|||<|0.0005|2-Sided|95.0|221.09|769.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and Na MFP/ NaF toothpaste (1450ppmF) and to be equal with respect to enamel fluoride uptake potential.|
1699184|NCT01005966|3122634|Superiority or Other||Adjusted Mean Difference|1879.4|||<|0.0001|2-Sided|95.0|1605.75|2153.04||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel fluoride uptake potential.|
1699185|NCT01005966|3122634|Superiority or Other||Adjusted Mean Difference|692.91|||<|0.0001|2-Sided|95.0|418.73|967.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel fluoride uptake potential.|
1699186|NCT01005966|3122634|Superiority or Other||Adjusted Mean Difference|532.61|||<|0.0002|2-Sided|95.0|259.06|806.16||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel fluoride uptake potential.|
1699187|NCT01005966|3122634|Superiority or Other||Adjusted Mean Difference|37.24|||<|0.7912|2-Sided|95.0|-239.62|314.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and AmF toothpaste (1400ppmF) to be equal with respect to enamel fluoride uptake potential.|
1699188|NCT01005966|3122635|Superiority or Other||Adjusted Mean Difference|26.56|||<|0.0001|2-Sided|95.0|21.88|31.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.|
1699189|NCT01005966|3122635|Superiority or Other||Adjusted Mean Difference|11.97|||<|0.0001|2-Sided|95.0|7.31|16.64||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for AmF toothpaste (1400ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.|
1699190|NCT01005966|3122635|Superiority or Other||Adjusted Mean Difference|7.58|||<|0.0017|2-Sided|95.0|2.88|12.27||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the AmF toothpaste (1400ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.|
1699224|NCT01005719|3122700|Superiority or Other|||||||0.0242||||||p-value for 10-15 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values <= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)||||
1699191|NCT01005966|3122635|Superiority or Other||Adjusted Mean Difference|14.59|||<|0.0001|2-Sided|95.0|9.95|19.23||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (675ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.|
1699192|NCT01005966|3122635|Superiority or Other||Adjusted Mean Difference|18.99|||<|0.0001|2-Sided|95.0|14.36|23.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.|
1699193|NCT01005966|3122635|Superiority or Other||Adjusted Mean Difference|4.4|||<|0.0625|2-Sided|95.0|-0.23|9.03||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the Na MFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.|
1699194|NCT01005966|3122635|Superiority or Other||Adjusted Mean Difference|23.55|||<|0.0001|2-Sided|95.0|18.86|28.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Placebo toothpaste (0ppmF) to be equal with respect to enamel remineralization potential.|
1699195|NCT01005966|3122635|Superiority or Other||Adjusted Mean Difference|4.57|||<|0.0557||95.0|-0.11|9.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and Na MFP/NaF toothpaste (1450ppmF) to be equal with respect to enamel remineralization potential.|
1699196|NCT01005966|3122635|Superiority or Other||Adjusted Mean Difference|8.96|||<|0.0002|2-Sided|95.0|4.27|13.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA based on a mixed model with factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for the NaF toothpaste (1426ppmF) and NaF toothpaste (675ppmF) to be equal with respect to enamel remineralization potential.|
1699197|NCT01005966|3122636|Superiority or Other||Adjusted Mean Difference|-3.01||||0.2117|2-Sided|95.0|-7.75|1.73||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|Analysis of variance (ANOVA) based on a mixed model with the factors subject, treatment and period was used.|Statistical tests were 2-sided with a significance level of 0.05.|Null hypothesis considered population means for NaF toothpaste and AmF toothpaste to be equal with respect to enamel remineralization potential.|
1699198|NCT01005888|3122661|Superiority or Other|||||||0.0002||||||Week 12 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)||||
1699199|NCT01005888|3122661|Superiority or Other||||||<|0.0001||||||Week 8 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)||||
1699200|NCT01005888|3122661|Superiority or Other||||||<|0.0001||||||Week 4 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)||||
1699201|NCT01005888|3122661|Superiority or Other||||||<|0.0001||||||Visit 1 percent change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)||||
1699202|NCT01005888|3122662|Superiority or Other|||||||0.0028||||||Week 12 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)||||
1699203|NCT01005888|3122662|Superiority or Other|||||||0.0001||||||Week 8 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)||||
1699204|NCT01005888|3122662|Superiority or Other||||||<|0.0001||||||Week 4 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)||||
1699205|NCT01005888|3122662|Superiority or Other||||||<|0.0001||||||Visit 1 change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)||||
1699206|NCT01005888|3122663|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1699207|NCT01005888|3122664|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1699208|NCT01005888|3122665|Superiority or Other|||||||0.0004|||||||Wilcoxon (Mann-Whitney)||||
1699209|NCT01005888|3122666|Superiority or Other|||||||0.0008|||||||Wilcoxon (Mann-Whitney)||||
1699210|NCT01005888|3122667|Superiority or Other||||||>|0.999||||||Period 2.|Fisher Exact||||
1699211|NCT01005888|3122667|Superiority or Other||||||>|0.999||||||Period 1.|Fisher Exact||||
1699212|NCT01005888|3122668|Superiority or Other||||||<|0.0001||||||Normalized number of attacks.|ANOVA||||
1699213|NCT01005888|3122668|Superiority or Other||||||<|0.0001||||||Observed number of attacks.|ANOVA||||
1699214|NCT01005810|3122674|Superiority||Odds Ratio (OR)|2.35||||0.029|2-Sided|95.0|1.05|5.24|||Regression, Logistic||||
1699215|NCT01005719|3122698|Superiority or Other||||||<|0.05||||||The statistical analysis is for Day 7 (0-5 mins).|Wilcoxon (Mann-Whitney)||||
1699216|NCT01005719|3122698|Superiority or Other||||||<|0.05||||||The statistical analysis is for Day 7 (0-5 mins).|Wilcoxon (Mann-Whitney)||||
1699217|NCT01005719|3122698|Superiority or Other||||||<|0.05||||||The statistical analysis is for Day 1 (0-5 mins).|Wilcoxon (Mann-Whitney)||||
1699218|NCT01005719|3122698|Superiority or Other||||||<|0.05||||||The statistical analysis is for Day 1 (0-5 mins).|Wilcoxon (Mann-Whitney)||||
1699219|NCT01005719|3122699|Superiority or Other||||||<|0.0001||||||p-value for 20-25 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)||||
1699220|NCT01005719|3122699|Superiority or Other||||||<|0.0012||||||p-value for 15-20 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)||||
1699221|NCT01005719|3122699|Superiority or Other||||||<|0.0465||||||p-value for 10-15 mins Post-dose on Day 1|Wilcoxon (Mann-Whitney)||||
1699222|NCT01005719|3122700|Superiority or Other|||||||0.0067||||||p-value for 20-25 mins Post-dose on Day 7. No adjustments were made for multiple comparisons. P-values <= 0.05 were reported as statistically significant.|Wilcoxon (Mann-Whitney)||||
1699225|NCT01005680|3122703|Superiority or Other|||||||0.627|||||||two-sided Z test||||
1699227|NCT01005680|3122706|Superiority or Other||Hazard Ratio (HR)|1.04||||0.861|2-Sided|95.0|0.67|1.61||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard||||
1699228|NCT01005680|3122707|Superiority or Other||Hazard Ratio (HR)|0.96||||0.887|2-Sided|95.0|0.51|1.79||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard||||
1699229|NCT01005680|3122708|Superiority or Other||Hazard Ratio (HR)|1.01||||0.928|2-Sided|95.0|0.78|1.32||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and biases for initial pathological diagnosis.|Cox Proportional Hazard||||
1699230|NCT01005680|3122709|Superiority or Other||Hazard Ratio (HR)|1.06||||0.64|2-Sided|95.0|0.82|1.37||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex and basis for initial pathological diagnosis.|Cox Proportional Hazard||||
1699231|NCT01005680|3122710|Superiority or Other||Hazard Ratio (HR)|1.03||||0.822|2-Sided|95.0|0.77|1.39||HR adjusted for treatment, disease stage, Eastern Cooperative Oncology Group Performance Status (ECOG PS), sex, and basis for initial pathological diagnosis.|Cox Proportional Hazard||||
1699232|NCT01005459|3122722|Other|unpaired t-test compared between groups|||||>|0.05|||||||unpaired t-test compared between groups||||
1699233|NCT01005459|3122722|Other|unpaired t-test|||||>|0.05|||||||unpaired t-test compared between groups||||
1699234|NCT01005329|3122749|Other||||||||||||||||||The rate of the acute specified AEs (adverse events) from previous (and prior to ClinicalTrials.gov requirements) Radiation Therapy Oncology Group (RTOG) trial 9708 of RT + cisplatin was 44% and the hypothesis is that the addition of bevacizumab to IMRT + cisplatin will not increase this rate beyond 60%. This study was designed with a 1-sided, upper bound confidence interval to estimate this AE rate. Twenty-seven evaluable patients were required to have 95% confidence that the true grade 3+ non-hematologic treatment-related AE rate is not greater than 60%. Please note that this is a 95% ONE-SIDED confidence bound which is equivalent to the upper bound of a two-sided 90% confidence interval.
1699235|NCT01005316|3122766|Superiority or Other|||||||0.258|||||||Fisher Exact|||The p-value compares Cohort A: Non-Sensitized with Cohort B: Sensitized, Crossmatch Positive.|
1699236|NCT01004614|3122866|Non-Inferiority or Equivalence|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|100.84|||||2-Sided|90.0|95.93|106.0||||||Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL <=µT - µR <=θU); null hypothesis of inequivalence: (Ho: µT - µR <θL or µT - µR >θU).|
1699237|NCT01004614|3122866|Non-Inferiority or Equivalence|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|99.3|||||2-Sided|90.0|92.28|106.28||||||Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL <=µT - µR <=θU); null hypothesis of inequivalence: (Ho: µT - µR <θL or µT - µR >θU).|
1699238|NCT01004614|3122867|Non-Inferiority or Equivalence|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|101.29|||||2-Sided|90.0|97.28|105.45|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL <=µT - µR <=θU); null hypothesis of inequivalence: (Ho: µT - µR <θL or µT - µR >θU).|
1699239|NCT01004614|3122867|Non-Inferiority or Equivalence|Bioequivalence of the two formulations was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCt and Cmax fell wholly within (80%, 125%).|ratios of adjusted geometric mean|98.61|||||2-Sided|90.0|93.09|104.46|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed AUCt was analyzed using a mixed effects model with sequence, period and formulation as fixed effects and subject within sequence as a random effect. Adjusted mean difference (test - reference) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL <=µT - µR <=θU); null hypothesis of inequivalence: (Ho: µT - µR <θL or µT - µR >θU).|
1699240|NCT01004432|3122874|Superiority or Other||Percentage achive ACR 20 response|34.9|||<|0.0001|2-Sided|95.0|30.4|39.4||One sided test adjusting for conducting one interim analysis|Chi-squared|||null hypothesis: proportion <=0.2|
1699241|NCT01004393|3122879|Superiority or Other|||||||0.161|||||||ANOVA||||
1699242|NCT01004107|3122929|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1699243|NCT01004107|3122930|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1699244|NCT01004107|3122933|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1699245|NCT01004107|3122934|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1699246|NCT01004107|3122935|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1699247|NCT01004107|3122936|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1699248|NCT01004003|3122937|Superiority or Other||Hazard Ratio (HR)|0.877|||||2-Sided|95.0|0.522|1.473|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."||
1699528|NCT00999167|3123630|Superiority or Other|||||||0.0713|||||||ANCOVA|||Changes in the Total Index Score from Baseline and Day 56.|
1699249|NCT01004003|3122938|Superiority or Other||Hazard Ratio (HR)|1.351|||||2-Sided|95.0|0.779|2.343|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."||
1699250|NCT01004003|3122941|Superiority or Other||Hazard Ratio (HR)|1.437|||||2-Sided|95.0|0.805|2.565|||||"Hazard ratio (HR) from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."||
1699251|NCT01003639|3122965|Superiority or Other||Mean Difference (Final Values)|0.71||||0.05|2-Sided|95.0|0.0|1.43|||ANCOVA||||
1699252|NCT01003184|3122985|Superiority or Other||Ratio|0.58|Standard Error of the Mean|0.322||0.3247|2-Sided|95.0|0.19|1.72|||Poisson regression|||The number of episodes by patient were compared between treatment groups using a poisson model with effects for treatment and baseline HbA1c and the logarithm of the days of exposure as the offset variable.|
1699253|NCT01003184|3122986|Superiority or Other||Least Squares Mean Difference|0.07|Standard Error of the Mean|0.107||0.4967|2-Sided|95.0|-0.14|0.28|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.|
1699254|NCT01003184|3122987|Superiority or Other||Least Squares Mean Difference|-0.01|Standard Error of the Mean|0.02||0.4638|2-Sided|95.0|-0.05|0.02|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.|
1699255|NCT01003184|3122988|Superiority or Other||Least Squares Mean Difference|-0.15|Standard Error of the Mean|0.09||0.1061|2-Sided|95.0|-0.32|0.03|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.|
1699256|NCT01003184|3122989|Superiority or Other||Least Squares Mean Difference|-0.45|Standard Error of the Mean|1.179||0.7034|2-Sided|95.0|-2.77|1.88|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.|
1699257|NCT01003184|3122990|Superiority or Other||Least Squares Mean Difference|-4.72|Standard Error of the Mean|1.853||0.0116|2-Sided|95.0|-8.37|-1.07|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.|
1699258|NCT01003184|3122991|Superiority or Other||Least Squares Mean Difference|0.1|Standard Error of the Mean|0.257||0.6993|2-Sided|95.0|-0.41|0.61|||ANCOVA|||ANCOVA model includes treatment group, baseline value, use of SU (yes/no) and baseline HbA1c stratum as factors.|
1699259|NCT01003184|3122992|Superiority or Other||Odds Ratio (OR)|4.89||||0.0002|2-Sided|95.0|2.1|11.35|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.|
1699260|NCT01003184|3122993|Superiority or Other||Odds Ratio (OR)|2.21||||0.0074|2-Sided|95.0|1.24|3.96|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.|
1699261|NCT01003184|3122994|Superiority or Other||Odds Ratio (OR)|1.79||||0.0497|2-Sided|95.0|1.0|3.18|||Regression, Logistic|||Logistic regression model includes independent variables treatment group, use of SU (yes/no), and baseline HbA1c.|
1699262|NCT01003184|3122995|Superiority or Other||Least Squares Mean Difference|-3.67|Standard Error of the Mean|0.488|<|0.0001|2-Sided|95.0|-4.63|-2.71|||Mixed Models Analysis|||Mixed model repeated measures MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), baseline HbA1c stratum, week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.|
1699263|NCT01003184|3122996|Superiority or Other||Least Squares Mean Difference|-0.41|Standard Error of the Mean|0.104||0.0001|2-Sided|95.0|-0.62|-0.2|||Mixed Models Analysis|||Mixed model repeated measures (MMRM) includes baseline value as covariate, study treatment, use of SU (yes/no), week of visit and treatment-by-week interaction as fixed effects and patient and error as random effects.|
1699264|NCT01003184|3122997|Superiority or Other||Odds Ratio (OR)|7.06|||<|0.0001|2-Sided|95.0|3.64|13.7|||Regression, Logistic|Logistic regression model includes the independent variables treatment group, use of SU (yes/no), baseline HbA1c and baseline weight.|||
1699265|NCT01003184|3122998|Superiority or Other||Odds Ratio (OR)|6.6|||<|0.0001|2-Sided|95.0|3.17|13.73|||Regression, Logistic|Logistic regression model includes treatment group, use of SU (yes/no), baseline HbA1c and baseline weight as main factors.||"Primary objective: to test hypothesis that the percentage of patients with HbA1c ≤7.0% with weight loss (≥1.0 kg) after exenatide QW is superior to insulin detemir.~Sample size estimation: based on the test for difference in percentage between Exenatide QW and insulin detemir. Assuming: common drop-out rate 20%, response rate at endpoint 50% in the exenatide QW group and 25% in the insulin detemir group; 5% significance. 214 patients will provide 90% power to detect a difference."|
1699266|NCT01002456|3123064|Superiority or Other||Odds Ratio (OR)|1.9|||||2-Sided|95.0|1.1|3.2|||||Proportional odds ratio to measure the trend of change in concordance with guideline recommendations, with Arm 1 as the comparator.||
1699267|NCT01002339|3123065|Superiority or Other|||||||0.9|||||||Chi-squared||||
1699268|NCT01002339|3123066|Superiority or Other|||||||0.5|||||||ANOVA||||
1699269|NCT01002339|3123067|Superiority or Other|||||||0.17|||||||Chi-squared||||
1699270|NCT01002339|3123068|Superiority or Other|||||||0.5|||||||ANOVA||||
1699271|NCT01002339|3123069|Superiority or Other|||||||0.45|||||||ANOVA||||
1699272|NCT01002339|3123070|Superiority or Other|||||||0.37|||||||ANOVA||||
1699273|NCT01002339|3123071|Superiority or Other|||||||0.66|||||||ANOVA||||
1699274|NCT01002339|3123072|Superiority or Other|||||||0.8|||||||Kruskal-Wallis||||
1699275|NCT01002339|3123073|Superiority or Other|||||||0.56|||||||ANOVA||||
1699276|NCT01002339|3123074|Superiority or Other|||||||0.8|||||||ANOVA||||
1699277|NCT01002339|3123075|Superiority or Other|||||||0.4|||||||ANOVA||||
1699278|NCT01002339|3123076|Superiority or Other|||||||0.2|||||||ANOVA||||
1699279|NCT01002339|3123077|Superiority or Other|||||||0.07|||||||Chi-squared||||
1699280|NCT01002339|3123078|Superiority or Other|||||||0.9|||||||Chi-squared||||
1699281|NCT01002339|3123079|Superiority or Other|||||||0.06|||||||Chi-squared||||
1699283|NCT01001520|3123140|Superiority or Other|||||||0.002||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase suppression of BOLD signal, meaning an increase in suppression of brain activity, in the ventromedial prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."|
1699284|NCT01001520|3123141|Superiority or Other|||||||0.98||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase suppression of BOLD signal, meaning an increase in suppression of brain activity, in the posterior cingulate cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."|
1699285|NCT01001520|3123142|Superiority or Other|||||||0.67||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the dorsal cingulate/medial prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."|
1699286|NCT01001520|3123143|Superiority or Other|||||||0.18||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the left dorsolateral prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."|
1699287|NCT01001520|3123144|Superiority or Other|||||||0.43||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers, while taking tolcapone (vs. placebo), would experience fewer withdrawal symptoms during their 24-hour abstinence period.|
1699288|NCT01001520|3123145|Superiority or Other|||||||0.4||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers, while taking tolcapone (vs. placebo), would experience less cigarette craving during their 24-hour abstinence period.|
1699289|NCT01001520|3123146|Superiority or Other|||||||0.85||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that smokers would smoke fewer cigarettes while taking tolcapone (vs. placebo).|
1699290|NCT01001520|3123147|Superiority or Other|||||||0.88||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Examined using random effects maximum likelihood regression.||We hypothesized that tolcapone (vs. placebo) would reduce subject's reaction time during the N-back working memory task.|
1699291|NCT01001520|3123148|Superiority or Other|||||||0.017||||||The threshold for statistical significance was not adjusted. Significance remained at p=0.05.|Regression, Linear|Accuracy was examined using random effects maximum likelihood regression.||We hypothesized that tolcapone (vs. placebo) would increase subject's accuracy during the N-back working memory task.|
1699292|NCT01001520|3123149|Superiority or Other|||||||0.88||||||"Because the five a priori brain regions of interest (ROIs) are highly correlated, the significance threshold was adjusted to p=0.014."|Regression, Linear|BOLD signal change was examined using random effects maximum likelihood regression.||"We hypothesized that tolcapone would increase BOLD signal, meaning there would be an increase in brain activity, in the right dorsolateral prefrontal cortex, a part of the brain known to be involved in working memory.~We analyzed for main effects of treatment (tolcapone vs. placebo), back level (0, 1, 2, and 3), treatment order, and relevant covariates (genotype, race, age, sex, FTND score, Shipley IQ score)."|
1699293|NCT01001429|3123170|Superiority or Other|||||||0.68|||||||Regression, Linear|||UMSS scores with subjects propofol vs. Dexmetomidine group|
1699294|NCT01001429|3123170|Superiority or Other|||||||0.04|||||||Regression, Logistic||||
1699295|NCT01001377|3123175|Superiority or Other||LS Mean Difference|-0.1998|||||2-Sided|95.0|-6.0093|5.6098|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.|
1699296|NCT01001377|3123176|Superiority or Other||LS Mean Difference|0.5836|||||2-Sided|95.0|-3.0269|4.1941|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.|
1699297|NCT01001377|3123177|Superiority or Other||LS Mean Difference|1.0372|||||2-Sided|95.0|-2.3267|4.401|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.|
1699298|NCT01001377|3123178|Superiority or Other||LS Mean Difference|-1.6745|||||2-Sided|95.0|-4.9331|1.5841|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.|
1699299|NCT01001377|3123179|Superiority or Other||LS Mean Difference|0.0126|||||2-Sided|95.0|-0.0353|0.0605|||||A positive difference between the treatment groups favors the panitumumab group.|Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.|
1699300|NCT01001377|3123183|Superiority or Other||Odds Ratio (OR)|1.15|||||2-Sided|95.0|0.83|1.58|||||Common treatment odds ratio stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).||
1699301|NCT01001377|3123185|Non-Inferiority or Equivalence|The overall survival non-inferiority hypothesis based on an asymptotic normal score was tested at a 1-sided 2.5% significance level. A value < -1.96 indicates non-inferiority at a significance level of 1-sided 0.025.|Normal score|-3.19||||0.0007||||||A synthesis approach with an asymptotic standard normal test statistic|Asymptotic standard normal test|||A synthesis approach with an asymptotic standard normal test statistic based on the logarithm of the hazard ratio was used to test the hypothesis that panitumumab is non-inferior to cetuximab for overall survival (ie, that panitumumab retains at least 50% of the overall survival benefit of cetuximab relative to best supportive care).|
1699302|NCT01001377|3123185|Superiority or Other||Stratified Cox proportional hazard ratio|0.966|||||2-Sided|95.0|0.839|1.113|||||Hazard ratio is presented as panitumumab : cetuximab. A value < 1.0 indicates a lower average event rate and longer time to event for panitumumab relative to cetuximab.|Cox proportional hazards model stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).|
1699303|NCT01001325|3123186|Superiority or Other|||||||0.685|||||||Fisher Exact|||"Null hypothesis: There is no difference in incidence of pandemic strain influenza infection for people given seasonal influenza vaccine compared to those given a placebo.~Power to detect a 2-fold difference if attack rate in non-vaccinated participants is 10%: 86%"|
1699304|NCT01001234|3123208|Superiority or Other||Odds Ratio (OR)|1.22||||0.178|2-Sided|95.0|0.91|1.63||This third secondary hypothesis was not formally tested since the first secondary was not statistically significant.|Regression, Logistic|||The comparison of rizatriptan versus placebo with respect to pain relief at 2 hours post Stage 2 dose for participants between 6 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe), age (6 to 11 years old or 12 to 17 years old), and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio >1 is in favor of the rizatriptan group.|
1699305|NCT01001234|3123209|Superiority or Other||Odds Ratio (OR)|1.52||||0.01|2-Sided|95.0|1.1|2.1||This second secondary hypothesis was not formally tested since the first secondary was not statistically significant.|Regression, Logistic|||The comparison of rizatriptan versus placebo with respect to pain freedom at 2 hours post Stage 2 dose for participants between 6 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe), age (6 to 11 years old or 12 to 17 years old), and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio >1 is in favor of the rizatriptan group.|
1699306|NCT01001234|3123210|Superiority or Other||Odds Ratio (OR)|1.35||||0.08|2-Sided|95.0|0.96|1.9||Secondary endpoints were to be formally tested only if the test of the primary endpoint was statistically significant at the α=0.0477 level. The secondary endpoints were then tested sequentially in a pre-specified order, each at the α=0.05 level.|Regression, Logistic|This first secondary hypothesis was not statistically significant, therefore the other two were not formally tested for statistical significance.||The comparison of rizatriptan versus placebo with respect to pain relief at 2 hours post Stage 2 dose for participants between 12 and 17 years of age was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe) and region (US or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio >1 is in favor of the rizatriptan group.|
1699307|NCT01001234|3123211|Superiority or Other||Odds Ratio (OR)|1.55||||0.025|2-Sided|95.0|1.06|2.26||The statistical significance level for the primary endpoint was α=0.0477, and had been adjusted to account for the interim sample size adjustment.|Regression, Logistic|Testing of primary endpoint and secondary endpoints was conducted sequentially in a pre-specified order, thus strongly controlling Type I error.||The comparison of rizatriptan versus placebo with respect to the primary outcome was conducted using a logistic regression model with factors for treatment, Stage 2 baseline pain severity (moderate or severe) and region (United States [US] or ex-US). Model-derived odds ratio and a two-sided p-value were provided. An odds ratio >1 is in favor of the rizatriptan group.|
1699308|NCT01001208|3123256|Superiority or Other|||||||0.1995||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|2-sided van Elteren test|Stratified by baseline body mass index group and prior anti-TNF exposure group|||
1699309|NCT01001208|3123257|Superiority or Other|||||||0.1995||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|2-sided van Elteren test|Stratified by baseline body mass index group and prior anti-TNF exposure group|||
1699310|NCT01001208|3123258|Superiority or Other|||||||0.0112||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group|||
1699311|NCT01001208|3123259|Superiority or Other|||||||0.0348||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group|||
1699312|NCT01001208|3123260|Superiority or Other|||||||0.0112||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group|||
1699313|NCT01001208|3123261|Superiority or Other|||||||0.0112||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group|||
1699529|NCT00999167|3123631|Superiority or Other||Hazard Ratio (HR)|0.56||||0.047||95.0|||||Regression, Cox||||
1699314|NCT01001208|3123262|Superiority or Other|||||||0.0112||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group|||
1699315|NCT01001208|3123263|Superiority or Other|||||||0.0112||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group|||
1699316|NCT01001208|3123264|Superiority or Other|||||||0.0112||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group|||
1699317|NCT01001208|3123265|Superiority or Other||||||<|0.0001||||||Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.|Cochran-Mantel-Haenszel|Stratified by baseline body mass index group and prior anti-TNF exposure group|||
1699318|NCT01001104|3123305|Superiority or Other|||||||0.233|||||||Fisher Exact||||
1699319|NCT01001104|3123305|Superiority or Other|||||||1|||||||Fisher Exact||||
1699320|NCT01001104|3123305|Superiority or Other|||||||0.073||||||This is the p-value from the Cochran-Armitage trend test (dose-effect).|Cochran-Armitage||||
1699321|NCT01001104|3123307|Superiority or Other||Least Squares Mean Difference|31.68|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis||||
1699322|NCT01001104|3123307|Superiority or Other||Least Squares Mean Difference|19.73|||<|0.002||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis||||
1699323|NCT01001104|3123307|Superiority or Other||Least Squares Mean Difference|13.1|||<|0.036||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis||||
1699324|NCT01001104|3123307|Superiority or Other||||||<|0.001||||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis||||
1699325|NCT01001104|3123308|Superiority or Other||Least Squares Mean Difference|-8.4||||0.346||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis||||
1699326|NCT01001104|3123308|Superiority or Other||Least Squares Mean Difference|-9.81||||0.264||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis||||
1699327|NCT01001104|3123308|Superiority or Other||Least Squares Mean Difference|0.91||||0.917||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis||||
1699328|NCT01001104|3123308|Superiority or Other|||||||0.202||||||This is the p-value from the linear trend test at week 12.|Mixed Models Analysis||||
1699329|NCT01001104|3123309|Superiority or Other||Least Squares Mean Difference|0.26||||0.556||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis||||
1699330|NCT01001104|3123309|Superiority or Other||Least Squares Mean Difference|0.45||||0.311||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis||||
1699331|NCT01001104|3123309|Superiority or Other||Least Squares Mean Difference|1.26||||0.005||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis||||
1699332|NCT01001104|3123309|Superiority or Other|||||||0.987||||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis||||
1699333|NCT01001104|3123310|Superiority or Other||Least Squares Mean Difference|-41.49|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis||||
1699334|NCT01001104|3123310|Superiority or Other||Least Squares Mean Difference|-45.63|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis||||
1699335|NCT01001104|3123310|Superiority or Other||Least Squares Mean Difference|-33.2|||<|0.001||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis||||
1699336|NCT01001104|3123310|Superiority or Other||||||<|0.001||||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis||||
1699337|NCT01001104|3123311|Superiority or Other||Least Squares Mean Difference|-28.48|||<|0.001||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis||||
1699338|NCT01001104|3123311|Superiority or Other||Least Squares Mean Difference|-19.54|||<|0.003||95.0||||Primary comparisons are based on the MMRM LS Mean Value at week 12.|Mixed Models Analysis||||
1699339|NCT01001104|3123311|Superiority or Other||Least Squares Mean Difference|-20.2|||<|0.003||95.0||||Primary comparisons are based on the MMRM Least Squares (LS) Mean Value at week 12.|Mixed Models Analysis||||
1699340|NCT01001104|3123311|Superiority or Other||||||<|0.001||||||This is the p-value for the linear trend test at week 12.|Mixed Models Analysis||||
1699341|NCT01001104|3123312|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1699342|NCT01001104|3123312|Superiority or Other||||||<|0.014|||||||Fisher Exact||||
1699343|NCT01001104|3123312|Superiority or Other||||||<|0.358|||||||Fisher Exact||||
1699344|NCT01001104|3123312|Superiority or Other||||||<|0.001||||||This is the p-value from the Cochran-Armitage trend test.|Cochran-Armitage||||
1699345|NCT01001104|3123313|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1699346|NCT01001104|3123313|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1699347|NCT01001104|3123313|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1699348|NCT01001104|3123313|Superiority or Other||||||<|0.001||||||This is the p-value from the Cochran-Armitage trend test.|Cochran-Armitage||||
1699349|NCT01001104|3123314|Superiority or Other||Least Squares Mean Difference|-1.17|||<|0.001||95.0|||||Mixed Models Analysis||||
1699350|NCT01001104|3123314|Superiority or Other||Least Squares Mean Difference|-0.97|||<|0.001||95.0|||||Mixed Models Analysis||||
1699351|NCT01001104|3123314|Superiority or Other||Least Squares Mean Difference|-0.72|||<|0.001||95.0|||||Mixed Models Analysis||||
1699352|NCT01001104|3123314|Superiority or Other||||||<|0.001||||||This is the p-value for the linear trend test at 12 weeks.|Mixed Models Analysis||||
1699530|NCT00999167|3123632|Superiority or Other|||||||0.0214|||||||Cochran-Mantel-Haenszel||||
1699353|NCT01000974|3123352|Non-Inferiority|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 3.|Difference in percentage|-0.66|||||2-Sided|97.5|-2.2|0.88||||||Non-inferiority Anti-Polio 3 concentration|
1699354|NCT01000974|3123352|Non-Inferiority|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 2.|Difference in percentage|0.45|||||2-Sided|97.5|-1.45|2.91||||||Non-inferiority Anti-Polio 2 concentration|
1699355|NCT01000974|3123352|Non-Inferiority|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to poliovirus 1.|Difference in percentage|-0.67|||||2-Sided|97.5|-2.24|0.87||||||Non-inferiority Anti-Polio 1 concentrations|
1699356|NCT01000974|3123353|Other|To rule out 10% decrease in seroresponse to PRN in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn & HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn &HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001||||||P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 and the posterior probability of the cut-off in the control group|t-test, 1 sided|||Difference in seroresponse Anti-PRN|
1699357|NCT01000974|3123353|Other|To rule out 10% decrease in seroresponse to PT in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn & HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn &HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001||||||P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 and the posterior probability of the cut-off in the control group|t-test, 1 sided|||Difference in seroresponse Anti-PT|
1699358|NCT01000974|3123353|Other|To rule out 10% decrease in seroresponse to FHA in subjects receiving DTPa-HBV-IPV coadministered with Test Hib,13Pn & HRV vaccines compared to subjects receiving DTPa-HBV-IPV co-administered with Control Hib, 13Pn &HRV vaccines,following 3 primary vaccine doses where seroresponse wasdefined as percentage of subjects showing aconcentration above a threshold that led to 95% seroresponse in control|||||<|0.0001|||||||t-test, 1 sided|P-value is computed by integrating on the p-values of one-sided test with alpha=0.025 & the posterior probability of the cut-off in the control group||Difference in seroresponse Anti-FHA|
1699359|NCT01000974|3123354|Non-Inferiority|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.031|||||2-Sided|97.5|0.862|1.232||||||Non-inferiority Anti-Pneumoniae 23F concentrations|
1699360|NCT01000974|3123354|Non-Inferiority|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|0.969|||||2-Sided|97.5|0.855|1.098||||||Non-inferiority Anti-Pneumoniae 19F concentrations|
1699361|NCT01000974|3123354|Non-Inferiority|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.001|||||2-Sided|97.5|0.859|1.167||||||Non-inferiority Anti-Pneumoniae 19A concentrations|
1699362|NCT01000974|3123354|Non-Inferiority|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.042|||||2-Sided|97.5|0.9|1.207||||||Non-inferiority Anti-Pneumoniae 18C concentrations|
1699363|NCT01000974|3123354|Non-Inferiority|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.096|||||2-Sided|97.5|0.929|1.294||||||Non-inferiority Anti-Pneumoniae 14 concentrations|
1699364|NCT01000974|3123354|Non-Inferiority|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.035|||||2-Sided|97.5|0.89|1.204||||||Non-inferiority Anti-Pneumoniae 9V concentrations|
1699365|NCT01000974|3123354|Non-Inferiority|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.098|||||2-Sided|97.5|0.964|1.251||||||Non-inferiority Anti-Pneumoniae 7F concentrations|
1699366|NCT01000974|3123354|Non-Inferiority|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.072|||||2-Sided|97.5|0.871|1.32||||||Non-inferiority Anti-Pneumoniae 6B concentrations|
1699367|NCT01000974|3123354|Non-Inferiority|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.031|||||2-Sided|97.5|0.894|1.188||||||Non-inferiority Anti-Pneumoniae 6A concentrations|
1699368|NCT01000974|3123354|Non-Inferiority|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.02|||||2-Sided|97.5|0.874|1.19||||||Non-inferiority Anti-Pneumoniae 5 concentrations|
1699531|NCT00999167|3123633|Superiority or Other|||||||0.0354|||||||Poisson regression adjusting for country||||
1702379|NCT00955201|3130434|Superiority|||||||0.63|||||||ANOVA|||Comparison across groups at 12-wks|
1699369|NCT01000974|3123354|Non-Inferiority|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.001|||||2-Sided|97.5|0.886|1.13||||||Non-inferiority Anti-Pneumoniae 4 concentrations|
1699370|NCT01000974|3123354|Non-Inferiority|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs.|GMC ratio|1.048|||||2-Sided|97.5|0.921|1.192||||||Non-inferiority Anti-Pneumoniae 3 concentrations|
1699371|NCT01000974|3123354|Non-Inferiority|To demonstrate the non-inferiority of a 3-dose primary vaccination course of 13Pn co-administered with Test Hib, HRV and DTPa-HBV-IPV compared to that of 13Pn co-administered with Control Hib, HRV and DTPa-HBV-IPV in terms of Streptococcus pneumoniae (S.pneumoniae) GMCs|GMC ratio|1.006|||||2-Sided|97.5|0.873|1.159||||||Non-inferiority Anti-Pneumoniae 1 concentrations|
1699372|NCT01000974|3123355|Non-Inferiority|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to pertactin [PRN]|GMC ratio|1.193|||||2-Sided|97.5|1.03|1.382||||||Non-inferiority GMC ratio anti-PRN|
1699373|NCT01000974|3123355|Non-Inferiority|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to filamentous hemagglutinin [FHA].|GMC ratio|1.088|||||2-Sided|97.5|0.983|1.204||||||Non-inferiority GMC ratio anti-FHA|
1699374|NCT01000974|3123355|Non-Inferiority|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to pertussis toxoid [PT].|GMC ratio|1.017|||||2-Sided|97.5|0.918|1.127||||||Non-inferiority GMC ratio anti-PT|
1699375|NCT01000974|3123357|Non-Inferiority|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to tetanus (Anti-T).|Difference in percentage|0.0|||||2-Sided|95.0|-1.26|1.8||||||Non-inferiority Anti-T antibody concentrations|
1699376|NCT01000974|3123357|Non-Inferiority|To demonstrate the non-inferiority of DTPa-HBV-IPV co-administered with Test Hib, 13Pn and HRV to DTPa-HBV-IPV co-administered with Control Hib, 13Pn and HRV, following 3 primary vaccine doses in terms of immune response to diphtheria (Anti-D).|Difference in percentage|0.0|||||2-Sided|95.0|-1.26|1.81||||||Non-inferiority Anti-D antibody concentrations|
1699377|NCT01000974|3123358|Non-Inferiority|To demonstrate the non-inferiority of Test Hib to Control Hib, each co-administered with DTPa-HBVIPV, 13Pn and HRV vaccines, following 3 primary vaccine doses in terms of anti-PRP antibody concentrations ≥ 0.15 μg/mL.|Difference in percentage|-0.11|||||2-Sided|95.0|-1.98|2.82||||||Non-inferiority Anti-PRP concentration≥ 0.15 μg/mL|
1699378|NCT01000974|3123358|Non-Inferiority|To demonstrate the non-inferiority of Test Hib to Control Hib, each co-administered with DTPa-HBV-IPV, 13Pn and HRV vaccines, following 3 primary vaccine doses in terms of anti-PRP antibody concentration ≥ 1.0 μg/mL.|difference in percentage|-8.59|||||2-Sided|95.0|-12.28|-4.07||||||Non-inferiority Anti-PRP concentration ≥ 1.0 μg/mL|
1699379|NCT01000961|3123359|Superiority or Other||Mean Difference (Final Values)|2.03|||||2-Sided|95.0|1.75|2.39|||||||
1699380|NCT01000961|3123360|Superiority or Other||Mean Difference (Final Values)|105.0|||||2-Sided|95.0|90.0|150.0|||||||
1699381|NCT01000961|3123361|Superiority or Other||Median Difference (Final Values)|1.4|||||2-Sided|95.0|1.17|1.67|||||||
1699382|NCT01000961|3123362|Non-Inferiority or Equivalence|The non-inferiority endpoint of the clinical trial would be achieved if the upper limit of the 95.8% CI of the difference between RP103 and Cystagon® was less than the a-priori 0.3 non-inferiority margin, which would correspond to an observed p-value less than or equal to 0.02104|Mean Difference (Final Values)|0.0785||||0.0001|2-Sided|95.8|0.0107|0.1464|||t-test, 1 sided||95.8% confidence interval was used instead of 95% to take into account a sample size re-estimation calculation that was performed after 20 patients were enrolled.|16-subject study will have 90% power to reject the null hypothesis of non-inferiority at the 0.025 level of significance with a non-inferiority margin of 0.3. Final analysis was performed at a nominal significance level of 0.02104.|
1699383|NCT01000818|3123363|Non-Inferiority or Equivalence|The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.|Geometric Mean Ratio|1.45||||||95.0|1.09|1.93|||||||
1699384|NCT01000818|3123363|Non-Inferiority or Equivalence|The raltegravir AUC0-12 hr geometric mean ratio (raltegravir + omeprazole/raltegravir) is noniferior at less than 2.0.|Geometric Mean Ratio|1.39||||||95.0|1.04|1.84|||||||
1699385|NCT01000805|3123364|Superiority or Other||Mean Difference (Final Values)|-0.88|||<|0.001|2-Sided|95.0|-1.24|-0.51||This is the p-value for the Change from Baseline up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA||||
1699386|NCT01000805|3123364|Superiority or Other||Mean Difference (Final Values)|-0.96|||<|0.001|2-Sided|95.0|-1.37|-0.54||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699387|NCT01000805|3123365|Superiority or Other||Mean Difference (Final Values)|0.31||||0.638|2-Sided|95.0|-0.98|1.6||This is the p-value for the Change from Baseline in DBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA||||
1699388|NCT01000805|3123365|Superiority or Other||Mean Difference (Final Values)|1.53||||0.124|2-Sided|95.0|-0.42|3.47||This is the p-value for the Change from Baseline in SBP up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA||||
1699389|NCT01000805|3123365|Superiority or Other||Mean Difference (Final Values)|0.47||||0.513|2-Sided|95.0|-0.95|1.9||This is the p-value for the Change from Baseline in DBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699532|NCT00999141|3123644|Superiority or Other||Difference in Proportions|-0.365||||||95.0|-0.528|-0.171|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)||
1699390|NCT01000805|3123365|Superiority or Other||Mean Difference (Final Values)|1.9||||0.083|2-Sided|95.0|-0.25|4.04||This is the p-value for the Change from Baseline in SBP at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699391|NCT01000805|3123366|Superiority or Other||Mean Difference (Final Values)|2.4||||0.001|2-Sided|95.0|0.97|3.83||This is the p-value for the Change up to Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|ANCOVA||||
1699392|NCT01000805|3123366|Superiority or Other||Mean Difference (Final Values)|2.92|||<|0.001|2-Sided|95.0|1.34|4.51||This is the p-value for the Change from Baseline at Week 8. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699393|NCT01000805|3123367|Superiority or Other|||||||0.033||||||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact||||
1699394|NCT01000805|3123368|Superiority or Other|||||||0.293||||||This is the p-value for suicidal ideation. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact||||
1699395|NCT01000805|3123369|Superiority or Other||Mean Difference (Final Values)|-0.48|||<|0.001|2-Sided|95.0|-0.71|-0.26||P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699396|NCT01000805|3123370|Superiority or Other||Mean Difference (Final Values)|-0.57|||<|0.001|2-Sided|95.0|-0.88|-0.25||This is the p-value for the main effect of treatment for the BPI Mean Pain Interference score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699397|NCT01000805|3123370|Superiority or Other||Mean Difference (Final Values)|-0.67|||<|0.001|2-Sided|95.0|-1.03|-0.31||This is the p-value for the main effect of treatment for the BPI Pain Interference with Enjoyment of Life score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699398|NCT01000805|3123370|Superiority or Other||Mean Difference (Final Values)|-0.39|||<|0.042|2-Sided|95.0|-0.76|-0.01||This is the p-value for the main effect of treatment for the BPI Pain Interference with Sleep score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699399|NCT01000805|3123370|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.001|2-Sided|95.0|-1.06|-0.35||This is the p-value for the main effect of treatment for the BPI Pain Interference with Relations with Others score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699400|NCT01000805|3123370|Superiority or Other||Mean Difference (Final Values)|-0.56|||<|0.002|2-Sided|95.0|-0.91|-0.21||This is the p-value for the main effect of treatment for the BPI Pain Interference with Normal Work score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699401|NCT01000805|3123370|Superiority or Other||Mean Difference (Final Values)|-0.45|||<|0.009|2-Sided|95.0|-0.79|-0.11||This is the p-value for the main effect of treatment for the BPI Pain Interference with Walking Ability score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699402|NCT01000805|3123370|Superiority or Other||Mean Difference (Final Values)|-0.73|||<|0.001|2-Sided|95.0|-1.09|-0.37||This is the p-value for the main effect of treatment for the BPI Pain Interference with Mood score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699403|NCT01000805|3123370|Superiority or Other||Mean Difference (Final Values)|-0.68|||<|0.001|2-Sided|95.0|-1.03|-0.33||This is the p-value for the main effect of treatment for the BPI Pain Interference with General Activity score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699404|NCT01000805|3123370|Superiority or Other||Mean Difference (Final Values)|-0.74|||<|0.001|2-Sided|95.0|-1.06|-0.42||This is the p-value for the main effect of treatment for the BPI Severity for Pain Right Now score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699405|NCT01000805|3123370|Superiority or Other||Mean Difference (Final Values)|-0.62|||<|0.001|2-Sided|95.0|-0.9|-0.33||This is the p-value for the main effect of treatment for the BPI Severity for Average Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699406|NCT01000805|3123370|Superiority or Other||Mean Difference (Final Values)|-0.62|||<|0.001|2-Sided|95.0|-0.9|-0.34||This is the p-value for main effect of treatment for the BPI Severity for Least Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699407|NCT01000805|3123370|Superiority or Other||Mean Difference (Final Values)|-0.64|||<|0.001|2-Sided|95.0|-0.97|-0.32||This is the p-value for the main effect of treatment for the BPI Severity for Worst Pain score. P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Mixed Models Analysis||||
1699408|NCT01000805|3123371|Superiority or Other||Mean Difference (Final Values)|-2.19||||0.001|2-Sided|95.0|-3.5|-0.89||This is the fifth gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p>0.05).|Mixed Models Analysis||||
1699409|NCT01000805|3123372|Superiority or Other||Mean Difference (Final Values)|-3.66|||<|0.001|2-Sided|95.0|-5.2|-2.11||This is the fourth gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p>0.05).|Mixed Models Analysis||||
1699410|NCT01000805|3123373|Superiority or Other|||||||0.0082||||||This is the third gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p>0.05).|Cochran-Mantel-Haenszel||||
1701473|NCT00969618|3128242|Superiority or Other||||||<|0.001||||||P-value is for inattention subscale score.|Paired t-test||||
1699411|NCT01000805|3123374|Superiority or Other|||||||0.001||||||This is the second gated secondary outcome measure. A gatekeeper strategy (Dmitrienko et al. 2003) controlled experiment-wise type I error for 5 secondary outcomes. Treatments were compared stepwise until an outcome failed to be significant (p>0.05).|Cochran-Mantel-Haenszel||||
1699412|NCT01000805|3123375|Superiority or Other||Mean Difference (Final Values)|-1.75||||0.019|2-Sided|95.0|-3.2|-0.29||P-value for the SDS Total score. First gated secondary outcome measure. Gatekeeper strategy controlled experiment-wise type I error for 5 secondary outcomes with stepwise comparisons of treatments until outcome failed to be significant (p>0.05).|Mixed Models Analysis||||
1699413|NCT01000805|3123375|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.04|2-Sided|95.0|-1.04|-0.02||This is the p-value for the Disrupt Family Life/Home score.|Mixed Models Analysis||||
1699414|NCT01000805|3123375|Superiority or Other||Mean Difference (Final Values)|-0.73||||0.005|2-Sided|95.0|-1.24|-0.22||This the p-value for the Disrupt Social Life/Leisure score.|Mixed Models Analysis||||
1699415|NCT01000805|3123375|Superiority or Other||Mean Difference (Final Values)|-0.46||||0.112|2-Sided|95.0|-1.03|0.11||This is the p-value for the Disrupt Work/School Work score.|Mixed Models Analysis||||
1699416|NCT01000805|3123376|Superiority or Other||Mean Difference (Final Values)|-4.04|||<|0.001|2-Sided|95.0|-5.83|-2.24|||Mixed Models Analysis||||
1699417|NCT01000805|3123377|Superiority or Other||Mean Difference (Final Values)|-0.62|||<|0.001|2-Sided|95.0|-0.9|-0.33||This p-value is for the main effect of treatment.|Mixed Models Analysis||||
1699418|NCT01000727|3123378|Superiority||Hazard Ratio (HR)|0.94||||0.362|2-Sided|95.0|0.81|1.08|||Cox Proportional Hazard Regression Model||||
1699419|NCT01000727|3123379|Superiority||Hazard Ratio (HR)|0.97||||0.546|2-Sided|95.0|0.87|1.07|||Cox Proportional Hazard Regression Model||A hazard ratio <1 indicates a lower risk with this treatment compared to Placebo||
1699420|NCT01000727|3123380|Superiority||Hazard Ratio (HR)|0.99||||0.797|2-Sided|95.0|0.9|1.08|||Cox Proportional Hazard Regression Model||||
1699421|NCT01000727|3123381|Superiority||Hazard Ratio (HR)|0.96||||0.329|2-Sided|95.0|0.87|1.05|||Cox Proportional Hazard Regression Model||||
1699422|NCT01000727|3123382|Superiority||Hazard Ratio (HR)|0.95||||0.202|2-Sided|95.0|0.88|1.03|||Cox Proportional Hazard Regression Model||A hazard ratio <1 indicates a lower risk with this treatment compared to Placebo||
1699423|NCT01000727|3123383|Superiority||Hazard Ratio (HR)|1.09||||0.36|2-Sided|95.0|0.91|1.31|||Cox Proportional Hazard Regression Model||||
1699424|NCT01000727|3123384|Superiority||Hazard Ratio (HR)|0.88||||0.161|2-Sided|95.0|0.73|1.05|||Cox Proportional Hazard Regression Model||||
1699425|NCT01000727|3123385|Superiority||Hazard Ratio (HR)|1.12||||0.354|2-Sided|95.0|0.88|1.42|||Cox Proportional Hazard Regression Model||A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo||
1699426|NCT01000727|3123386|Superiority||Hazard Ratio (HR)|0.97||||0.631|2-Sided|95.0|0.86|1.09|||Cox Proportional Hazard Regression Model||A hazard ratio <1 indicates a lower risk with this treatment compared to Placebo||
1699427|NCT01000727|3123387|Superiority||Hazard Ratio (HR)|0.91||||0.274|2-Sided|95.0|0.76|1.08||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model||||
1699428|NCT01000727|3123388|Superiority||Hazard Ratio (HR)|0.99||||0.777|2-Sided|95.02|0.9|1.09||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model||||
1699429|NCT01000727|3123389|Superiority||Hazard Ratio (HR)|1.0||||0.929|2-Sided|95.02|0.91|1.09||Statistical significance of this p-value is based on the alpha-spending function of this study.|Cox Proportional Hazard Regression Model||||
1699430|NCT01000506|3123432|Superiority or Other||Rate Ratio|0.48|||<|0.001|2-Sided|95.0|0.36|0.64||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 750 mg IV arm divided by the number of exacerbations per year in the placebo arm.||
1699431|NCT01000506|3123432|Superiority or Other||Rate Ratio|0.61|||<|0.001|2-Sided|95.0|0.46|0.81||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 250 mg IV arm divided by the number of exacerbations per year in the placebo arm.||
1699432|NCT01000506|3123432|Superiority or Other||Rate Ratio|0.52|||<|0.001|2-Sided|95.0|0.39|0.69||Hochberg testing procedure with a one-sided alpha of 2.5% used for controlling multiplicity|Negative Binomial regression model||Number of exacerbations per year in the mepolizumab 75mg IV arm divided by the number of exacerbations per year in the placebo arm.||
1699433|NCT01000493|3123439|Superiority or Other||Mean Difference (Net)|-0.27||||0.8954|2-Sided|95.0|-4.36|3.83||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.||
1699434|NCT01000493|3123439|Superiority or Other||Mean Difference (Net)|-2.88||||0.0927|2-Sided|95.0|-6.25|0.49||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 10.||
1699435|NCT01000493|3123439|Superiority or Other||Mean Difference (Net)|-2.86||||0.0582|2-Sided|95.0|-5.83|0.1||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.||
1699436|NCT01000493|3123439|Superiority or Other||Mean Difference (Net)|-2.89||||0.021|2-Sided|95.0|-5.33|-0.45||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 6.||
1699437|NCT01000493|3123439|Superiority or Other||Mean Difference (Net)|-1.89||||0.1155|2-Sided|95.0|-4.26|0.47||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.||
1699438|NCT01000493|3123439|Superiority or Other||Mean Difference (Net)|-1.94||||0.0311|2-Sided|95.0|-3.71|-0.18||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 2.||
1699439|NCT01000493|3123439|Superiority or Other||Mean Difference (Net)|-1.92||||0.0083|2-Sided|95.0|-3.33|-0.5||The MMRM analysis model included treatment, week, Baseline total HAM-D score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1||
1699440|NCT01000493|3123446|Superiority or Other||Mean Difference (Net)|-0.32||||0.2814|2-Sided|95.0|-0.9|0.27||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.||
1699441|NCT01000493|3123446|Superiority or Other||Mean Difference (Net)|-0.44||||0.1095|2-Sided|95.0|-0.98|0.1||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 10.||
1699442|NCT01000493|3123446|Superiority or Other||Mean Difference (Net)|-0.61||||0.0064|2-Sided|95.0|-1.04|-0.18||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.||
1699443|NCT01000493|3123446|Superiority or Other||Mean Difference (Net)|-0.3||||0.1341|2-Sided|95.0|-0.69|0.09||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 6.||
1699444|NCT01000493|3123446|Superiority or Other||Mean Difference (Net)|-0.01||||0.9698|2-Sided|95.0|-0.35|0.34||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.||
1699445|NCT01000493|3123446|Superiority or Other||Mean Difference (Net)|-0.2||||0.1181|2-Sided|95.0|-0.46|0.05||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 2.||
1699446|NCT01000493|3123446|Superiority or Other||Mean Difference (Net)|-0.12||||0.1743|2-Sided|95.0|-0.29|0.05||The MMRM analysis model included treatment, week, baseline CGI-S score, and the treatment by week and baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.||
1699447|NCT01000493|3123447|Superiority or Other||Odds Ratio (OR)|3.33||||0.1032|2-Sided|95.0|0.78|14.1|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 12.||
1699448|NCT01000493|3123447|Superiority or Other||Odds Ratio (OR)|3.17||||0.0588|2-Sided|95.0|0.96|10.5|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 10.||
1699449|NCT01000493|3123447|Superiority or Other||Odds Ratio (OR)|1.83||||0.2767|2-Sided|95.0|0.61|5.48|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 8.||
1699450|NCT01000493|3123447|Superiority or Other||Odds Ratio (OR)|2.48||||0.0662|2-Sided|95.0|0.94|6.53|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 1||
1699451|NCT01000493|3123447|Superiority or Other||Odds Ratio (OR)|1.05||||0.9234|2-Sided|95.0|0.42|2.62|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 4.||
1699452|NCT01000493|3123447|Superiority or Other||Odds Ratio (OR)|1.46||||0.4508|2-Sided|95.0|0.54|3.93|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. The analysis method was logistic regression adjusted for Baseline total CGI-S score. Comparison between placebo and orvepitant 60 mg once daily at Week 2.||
1699453|NCT01000493|3123447|Superiority or Other||Odds Ratio (OR)|1.57||||0.5532|2-Sided|95.0|0.36|6.92||The analysis method was logistic regression adjusted for Baseline total Clinical Global Impression-Severity of Illness scales (CGI-S) score.|Logistic regression analysis||Odds ratios represent the odds of improvement, relative to placebo. Comparison between placebo and orvepitant 60 mg once daily at Week 1.||
1699454|NCT01000493|3123448|Superiority or Other||Mean Difference (Net)|-0.92||||0.6711|2-Sided|95.0|-5.22|3.39||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.||
1699455|NCT01000493|3123448|Superiority or Other||Mean Difference (Net)|-0.07||||0.9712|2-Sided|95.0|-3.91|3.77||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.||
1699456|NCT01000493|3123448|Superiority or Other||Mean Difference (Net)|1.32||||0.3326|2-Sided|95.0|-1.37|4.0||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.||
1699457|NCT01000493|3123448|Superiority or Other||Mean Difference (Net)|-0.09||||0.919|2-Sided|95.0|-1.93|1.74||The MMRM analysis model included treatment, week, Baseline CAPS hyperarousal subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.||
1699458|NCT01000493|3123449|Superiority or Other||Mean Difference (Net)|-1.98||||0.4915|2-Sided|95.0|-7.71|3.75||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 12.||
1699459|NCT01000493|3123449|Superiority or Other||Mean Difference (Net)|-2.22||||0.3827|2-Sided|95.0|-7.27|2.83||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.||
1699460|NCT01000493|3123449|Superiority or Other||Mean Difference (Net)|0.51||||0.7552|2-Sided|95.0|-2.73|3.75||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.||
1699461|NCT01000493|3123449|Superiority or Other||Mean Difference (Net)|0.67||||0.5426|2-Sided|95.0|-1.51|2.85||The MMRM analysis model included treatment, week, Baseline CAPS A/N subscore and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.||
1699462|NCT01000493|3123451|Superiority or Other||Odds Ratio (OR)|0.92||||0.9486|2-Sided|95.0|0.07|12.5|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 12.||
1699463|NCT01000493|3123451|Superiority or Other||Odds Ratio (OR)|1.18||||0.908||95.0|0.07|20.1|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 8.||
1699464|NCT01000493|3123451|Superiority or Other||Odds Ratio (OR)|0.49||||0.5719|2-Sided|95.0|0.04|5.82|||Logistic regression analysis||Odds ratios represent the odds of improvement, relative to place. Comparison between placebo and orvepitant 60 mg once daily at Week 4.||
1699465|NCT01000493|3123452|Superiority or Other||Mean Difference (Net)|-4.64||||0.3702|2-Sided|95.0|-14.9|5.62||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 8.||
1699466|NCT01000493|3123452|Superiority or Other||Mean Difference (Net)|2.81||||0.4292|2-Sided|95.0|-4.22|9.84||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 4.||
1699467|NCT01000493|3123452|Superiority or Other||Mean Difference (Net)|-0.87||||0.7015|2-Sided|95.0|-5.35|3.61||The MMRM analysis model included treatment, week, Baseline total CAPS score, and the treatment by week and Baseline by week interaction terms. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between placebo and orvepitant 60 mg once daily at Week 1.||
1699468|NCT01000493|3123454|Superiority or Other||Odds Ratio (OR)|3.27||||0.1331|2-Sided|95.0|0.7|15.4|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.||
1699469|NCT01000493|3123454|Superiority or Other||Odds Ratio (OR)|2.4||||0.1208|2-Sided|95.0|0.79|7.28|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 8. Odds ratios represent the odds of improvement, relative to placebo.||
1699470|NCT01000493|3123454|Superiority or Other||Odds Ratio (OR)|0.64||||0.3024|2-Sided|95.0|0.27|1.5|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.||
1699471|NCT01000493|3123454|Superiority or Other||Odds Ratio (OR)|1.91||||0.3156|2-Sided|95.0|0.54|6.76|||Logistic regression analysis|The analysis method was logistic regression adjusted for Baseline CAPS total score.|Comparison between Placebo and Orvepitant 60 mg at Week 1. Odds ratios represent the odds of improvement, relative to placebo.||
1699472|NCT01000493|3123455|Superiority or Other||Mean Difference (Net)|-5.62||||0.3624|2-Sided|95.0|-17.9|6.65||The mixed effects model repeated measures (MMRM) analysis included treatment, week, Baseline total CAPS score and the treatment by week and Baseline. Week was used as the repeated effect in the model.|MMRM analysis||Comparison between Placebo and Orvepitant 60 mg at Week 12.||
1699473|NCT01000480|3123458|Superiority or Other|||||||0.0645||||||P-value for H0 which compared the investigational regimen to historical data.|maximum likelihood estimate|||Null hypothesis (H0): 1-year PFS ≤45% and the alternative hypothesis (H1): 1-year PFS ≥60%, at a 2-sided alpha level of 5%, assuming that PFS time followed an exponential distribution.|
1699474|NCT01000311|3123476|Non-Inferiority or Equivalence|The immune response as GMC of antibodies to pneumococcal PnC 23F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.84|||||2-Sided|95.0|0.68|1.04||||||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 23F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone|
1699475|NCT01000311|3123476|Non-Inferiority or Equivalence|The immune response as GMC of antibodies to pneumococcal PnC 19F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.89|||||2-Sided|95.0|0.73|1.07||||||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 19F antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone|
1699476|NCT01000311|3123476|Non-Inferiority or Equivalence|The immune response as GMC of antibodies to pneumococcal PnC 18C antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.99|||||2-Sided|95.0|0.82|1.2||||||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 18C antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone|
1699477|NCT01000311|3123476|Non-Inferiority or Equivalence|The immune response as GMC of antibodies to pneumococcal PnC 14 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|1.04|||||2-Sided|95.0|0.84|1.28||||||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 14 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone|
1699478|NCT01000311|3123476|Non-Inferiority or Equivalence|The immune response as GMC of antibodies to pneumococcal PnC 9V antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.87|||||2-Sided|95.0|0.72|1.06||||||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 9V antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone|
1699479|NCT01000311|3123476|Non-Inferiority or Equivalence|The immune response as GMC of antibodies to pneumococcal PnC 6B antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.76|||||2-Sided|95.0|0.62|0.93||||||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 6B antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone|
1699480|NCT01000311|3123476|Non-Inferiority or Equivalence|The immune response as GMC of antibodies to pneumococcal PnC 4 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Prevnar group divided by GMC of Prevnar group) was greater than 0.50.|GMCs ratio|0.98|||||2-Sided|95.0|0.8|1.19||||||To demonstrate the non-inferiority of GMC of antibodies to pneumococcal PnC 4 antigen when PCV is given with MenACWY-CRM compared with when PCV is given alone|
1699481|NCT01000311|3123477|Non-Inferiority or Equivalence|The immune response measured as GMC of antibodies to pertussis FIM antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.09|||||2-Sided|95.0|0.88|1.35||||||To demonstrate the non-inferiority of GMC of antibodies to pertussis FIM antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone|
1699482|NCT01000311|3123477|Non-Inferiority or Equivalence|The immune response measured as GMC of antibodies to pertussis pertactin antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.04|||||2-Sided|95.0|0.84|1.28||||||To demonstrate the non-inferiority of GMC of antibodies to pertussis pertactin antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone|
1699483|NCT01000311|3123477|Non-Inferiority or Equivalence|The immune response measured as GMC of antibodies to pertussis FHA antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.04|||||2-Sided|95.0|0.9|1.19||||||To demonstrate the non-inferiority of GMC of antibodies to pertussis FHA antigen, when DTaP is given with MenACWY-CRM compared with when DTaP is given alone|
1699484|NCT01000311|3123477|Non-Inferiority or Equivalence|The immune response measured as GMC of antibodies to pertussis toxin (PT), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the ratio of GMCs (GMC of MenACWY-CRM + Routine Vaccines group divided by GMC of Routine Vaccines group) was greater than 0.67.|GMCs ratio|1.02|||||2-Sided|95.0|0.81|1.28||||||To demonstrate the non-inferiority of GMC of antibodies to pertussis toxin (PT), when DTaP is given with MenACWY-CRM compared with when DTap is given alone|
1699485|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to pneumococcal PnC 23F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-5.0|||||2-Sided|95.0|-11.4|0.5||||||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 23F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone|
1699486|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to pneumococcal PnC 19F antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|3.0|||||2-Sided|95.0|1.3|7.1||||||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 19F antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone|
1699487|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to pneumococcal PnC 18C antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-3.0|||||2-Sided|95.0|-7.3|1.6||||||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 18C antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone|
1699533|NCT00999141|3123645|Superiority or Other||Difference in Proportions|-0.347||||||95.0|-0.518|-0.145|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)||
1699534|NCT00999141|3123646|Superiority or Other||Difference in Proportions|-0.227||||||95.0|-0.413|-0.02|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)||
1699488|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to pneumococcal PnC 14 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||2-Sided|95.0|-2.8|3.0||||||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 14 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone|
1699489|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to pneumococcal PnC 9V antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-3.0|||||2-Sided|95.0|-8.7|2.3||||||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 9V antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone|
1699490|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to pneumococcal PnC 6B antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-4.0|||||2-Sided|95.0|-10.3|3.2||||||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 6B antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone|
1699491|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to pneumococcal PnC 4 antigen, when PCV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of PCV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|1.0|||||2-Sided|95.0|-1.9|4.6||||||To demonstrate the non-inferiority of seroresponse to pneumococcal PnC 4 antigen, when PCV is given with MenACWY-CRM, compared with when PCV is given alone|
1699492|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to polio antigen (Type 3), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|-1.0|||||2-Sided|95.0|-3.3|1.7||||||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 3), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone|
1699493|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to polio antigen (Type 2), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|1.0|||||2-Sided|95.0|-1.4|3.0||||||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 2), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone|
1699494|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to polio antigen (Type 1), when IPV is given concomitantly with MenACWY-CRM, was considered non-inferior to that of IPV given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -5%.|Group difference|1.0|||||2-Sided|95.0|-3.1|5.4||||||To demonstrate the non-inferiority of seroresponse to polio antigen (Type 1), when IPV routine is given with MenACWY-CRM, compared with when IPV is given alone|
1699495|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to Hib vaccine, when given concomitantly with MenACWY-CRM, was considered non-inferior to that of Hib vaccine given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|5.0|||||2-Sided|95.0|0.0|11.2||||||To demonstrate the non-inferiority of seroresponse to Hib antigen, when Hib vaccine is given with MenACWY-CRM compared with when Hib vaccine is given alone.|
1699496|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to hepatitis B, when given concomitantly with MenACWY-CRM, was considered non-inferior to that of hepatitis B vaccine given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||2-Sided|95.0|-5.2|4.5||||||To demonstrate the non-inferiority of seroresponse to hepatitis B antigen, when hepatitis B vaccine is given with MenACWY-CRM compared with when hepatitis B vaccine is given alone.|
1699497|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to pertussis FIM antigen, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-2.0|||||2-Sided|95.0|-10.6|6.8||||||To demonstrate the non-inferiority of seroresponse to pertussis FIM antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone|
1699498|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to pertussis pertactin antigen, when DTaP vaccine is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||2-Sided|95.0|-8.8|9.1||||||To demonstrate the non-inferiority of seroresponse to pertussis pertactin antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP is given alone.|
1699499|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to pertussis (FHA antigen), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|4.0|||||2-Sided|95.0|-5.1|13.6||||||To demonstrate the non-inferiority of seroresponse to pertussis FHA antigen, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone|
1699500|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to pertussis toxin (PT), when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|-4.0|||||2-Sided|95.0|-12.1|4.3||||||To demonstrate the non-inferiority of seroresponse to pertussis toxin (PT), when DTaP vaccine is given, compared with MenACWY-CRM compared with when DTaP vaccine is given alone|
1699501|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to tetanus toxin, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||2-Sided|95.0|-3.3|3.9||||||To demonstrate the non-inferiority of seroresponse to tetanus toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone|
1699502|NCT01000311|3123478|Non-Inferiority or Equivalence|The immune seroresponse to diphtheria toxin, when DTaP is given concomitantly with MenACWY-CRM, was considered non-inferior to that of DTaP given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than or equal to -10%.|Group difference|0.0|||||2-Sided|95.0|-2.9|2.6||||||To demonstrate the non-inferiority of seroresponse to diphtheria toxin, when DTaP vaccine is given with MenACWY-CRM compared with when DTaP vaccine is given alone|
1699503|NCT01000311|3123482|Superiority or Other||Lowe limit of 95% confidence interval|92.0|||||2-Sided|95.0|92.0|99.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup Y.|
1699504|NCT01000311|3123482|Superiority or Other||Lower limit of 95% confidence interval|93.0|||||2-Sided|95.0|93.0|99.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup W.|
1699505|NCT01000311|3123482|Superiority or Other||Lower limit of 95% confidence interval|90.0|||||2-Sided|95.0|90.0|98.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 85% for the serogroup C.|
1699506|NCT01000311|3123482|Superiority or Other||Lower limit of 95% confidence interval|83.0|||||2-Sided|95.0|83.0|93.0||||||The null hypothesis associated with the primary objective was that the immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after 4th dose was greater than 80% for the serogroup A.|
1699507|NCT01000064|3123496|Superiority or Other|||||||0.047|||||||t-test, 2 sided||||
1699508|NCT01000064|3123497|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1699509|NCT01000064|3123498|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1699510|NCT01000064|3123499|Superiority or Other|||||||0.047|||||||t-test, 2 sided||||
1699511|NCT01000064|3123500|Superiority or Other|||||||0.047|||||||t-test, 2 sided||||
1699512|NCT01000064|3123501|Superiority or Other|||||||0.052|||||||t-test, 2 sided||||
1699513|NCT01000064|3123502|Superiority or Other|||||||0.053|||||||t-test, 2 sided||||
1699514|NCT01000025|3123505|Superiority or Other (legacy)||Odds Ratio (OR)|6.11||||0.001|2-Sided|95.0|1.84|20.3|||Cochran-Mantel-Haenszel||||
1699515|NCT01000025|3123506|Superiority or Other (legacy)||Hazard Ratio (HR)|0.66|||<|0.0001|2-Sided|95.0|0.55|0.79|||Log Rank|Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.|||
1699516|NCT01000025|3123507|Superiority or Other (legacy)||Hazard Ratio (HR)|0.98||||0.46|2-Sided|95.0|0.67|1.44||1-sided pvalue|Log Rank||||
1699517|NCT01000025|3123508|Superiority or Other (legacy)||Hazard Ratio (HR)|0.79||||0.043|2-Sided|95.0|0.61|1.03||1-sided p-value|Log Rank|Stratified by stratification factors at randomization except study center.|||
1699518|NCT01000025|3123509|Superiority or Other (legacy)||Hazard Ratio (HR)|1.0||||0.506|2-Sided|95.0|0.83|1.21||Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.1-sied p-value.|Log Rank|Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.||The trial was designed to detect a 25% deduction in risk of death with PF-804 with 90% power using a 1-sided 2.5% level significance test. The sample size was estimated as 720 patients.|
1699519|NCT00999804|3123519|Superiority or Other||proportion of CR+PR in 24 weeks arm|0.69|||||2-Sided|||||||||No comparison between the 2 arm is required for this study.|
1699520|NCT00999804|3123520|Superiority or Other||proportion of tpCR in 24 weeks arm|0.1|||||2-Sided|||||||||No comparison between the two arms is required.|
1699521|NCT00999804|3123521|Superiority or Other||proportion of patients with AE|0.72|||||2-Sided||||||||61 out of 85 patients (72%) in the 24-week arm had at least 1 adverse events.|This outcome is to establish the safety and tolerability of an extended regimen of lapatinib + trastuzumab, with or without endocrine therapy. No comparison between the 2 arms is required.|
1699522|NCT00999804|3123522|Superiority or Other||proportion of pCR|0.25|||||2-Sided||||||||No comparison is required between the 24 weeks arm and 12 weeks arm. The study is designed as the 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design and required 20 or more responses in the first 55 evaluable patients.|"The study was planned to enroll 136 patients if the original cohort (n=90) was deemed successful. The 24 weeks arm ran as a single arm, using an admissible Simon-like two-stage design. The 12 weeks arm accrued as long as the 24 weeks arm is open.~The analysis of the first cohort indicated that 15 pCR were observed , which did not meet the required 20 or more responses. The accrual was closed early and the study has a total of 128 participants."|
1699523|NCT00999661|3123530|Superiority or Other||Mean Difference (Final Values)|-7.97|Standard Deviation|5.233|<|0.0001||95.0|-8.65|-7.29|||t-test, 2 sided||||
1699524|NCT00999661|3123531|Superiority or Other||Mean Difference (Final Values)|36.6|Standard Deviation|19.79|<|0.0001||95.0|34.0|39.2|||t-test, 2 sided||||
1699525|NCT00999661|3123532|Superiority or Other||Mean Difference (Final Values)|39.8|Standard Deviation|25.12|<|0.0001||95.0|36.6|43.1||One-sample t-test for change from baseline|t-test, 2 sided||||
1699526|NCT00999544|3123539|Superiority or Other||||||<|0.05|||||||ANOVA|||"Area-under-the-curve (AUC) scores were derived from time course data and analyzed using two-factor ANOVA [aprepitant dose (3 levels)x oxycodone dose (3 levels)].~All analyses were conducted using SAS 9.1 for Windows (SAS Institute Inc., Cary, NC, USA) and were considered significant when P 0.05."|
1701474|NCT00969618|3128242|Superiority or Other||||||<|0.001||||||P-value is for total ADHD symptoms score.|Paired t-test||||
1699535|NCT00999141|3123647|Superiority or Other||Difference in Proportions|-0.413||||||95.0|-0.577|-0.213|||||Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)||
1699536|NCT00999141|3123650|Superiority or Other||Difference in proportions|-0.189||||0.027||95.0|-0.342|-0.023|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr||
1699537|NCT00999141|3123651|Superiority or Other||Difference in proportions|-0.356||||0.001||95.0|-0.521|-0.161|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr||
1699538|NCT00999141|3123652|Superiority or Other||Difference in proportions|-0.387|||<|0.001||95.0|-0.538|-0.205|||McNemar||Difference in Proportions = SoC - FS VH S/D 4 s-apr||
1699539|NCT00999141|3123653|Superiority or Other||Difference in proportions|-0.373|||<|0.001||95.0|-0.524|-0.193|||McNemar|alpha = 5%|Difference in proportions = SoC - FS VH S/D 4 s-apr||
1699540|NCT00999141|3123654|Superiority or Other||Difference in Proportions|0.04||||0.257||95.0|-0.039|0.125|||McNemar|alpha = 5%|Difference in Proportions = (SoC) - (FS VH S/D 4 s-apr)||
1699541|NCT00999141|3123657|Superiority or Other||||||<|0.0001|||||||two-sided paired t-test|alpha = 5%|||
1699542|NCT00999102|3123658|Superiority||Mean Difference (Final Values)|-25.9||||0.43|2-Sided|95.0|-91.55|39.75|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Treadmill Exercise Time for Nebivolol 10 mg minus Mean Treadmill Exercise Time for Metoprolol 100 mg.|The null hypothesis is that there is no difference in Treadmill Exercise Time after 4 weeks of Nebivolol 10 mg (higher dose) vs. 4 weeks of Metoprolol 100 mg (higher dose).|
1699543|NCT00999102|3123658|Superiority||Mean Difference (Final Values)|-7.03||||0.89|2-Sided|95.0|-108.99|94.92|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Treadmill Exercise Time for Nebivolol 5 mg minus Mean Treadmill Exercise Time for Metoprolol 50 mg.|The null hypothesis is that there is no difference in Treadmill Exercise Time after 4 weeks of Nebivolol 5 mg (lower dose) vs. 4 weeks of Metoprolol 50 mg (lower dose).|
1699544|NCT00999102|3123659|Superiority||Mean Difference (Final Values)|0.7||||0.72|2-Sided|95.0|-3.17|4.55|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Global Fatigue Score for Nebivolol 10 mg minus Mean Global Fatigue Score for Metoprolol 100 mg.|The null hypothesis is that there is no difference in the Global Fatigue Score after 4 weeks of Nebivolol 10 mg (higher dose) vs. 4 weeks of Metoprolol 100 mg (higher dose).|
1699545|NCT00999102|3123659|Superiority||Mean Difference (Final Values)|0.5||||0.67|2-Sided|95.0|-1.86|2.86|||t-test, 2 sided|Paired t-test was performed since each participant received both interventions in a crossover design.|Direction of Comparison: Mean Global Fatigue Score for Nebivolol 5 mg minus Mean Global Fatigue Score for Metoprolol 50 mg.|The null hypothesis is that there is no difference in the Global Fatigue Score after 4 weeks of Nebivolol 5 mg (lower dose) vs. 4 weeks of Metoprolol 50 mg (lower dose).|
1699546|NCT00998985|3123663|Superiority or Other||LSM difference|4.21|||||2-Sided|90.0|3.6|4.81|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10|
1699547|NCT00998985|3123663|Superiority or Other||LSM difference|4.98|||||2-Sided|90.0|4.42|5.53|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10|
1699548|NCT00998985|3123663|Superiority or Other||LSM Difference|3.84|||||2-Sided|90.0|3.29|4.4|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10|
1699549|NCT00998985|3123663|Superiority or Other||LSM Difference|2.94|||||2-Sided|90.0|2.38|3.49|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10|
1699550|NCT00998985|3123663|Superiority or Other||LSM Difference|2.25|||||2-Sided|90.0|1.7|2.81|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT3 viral load by at least 2 log10|
1699551|NCT00998985|3123664|Superiority or Other||LSM Difference|5.34|||||2-Sided|90.0|4.93|5.74|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10|
1699552|NCT00998985|3123664|Superiority or Other||LSM Difference|4.93|||||2-Sided|90.0|4.36|5.5|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10|
1699553|NCT00998985|3123664|Superiority or Other||LSM Difference|4.76|||||2-Sided|90.0|4.19|5.33|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10|
1699554|NCT00998985|3123664|Superiority or Other||LSM Difference|5.15|||||2-Sided|90.0|4.58|5.72|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10|
1699555|NCT00998985|3123664|Superiority or Other||LSM Difference|4.35|||||2-Sided|90.0|3.78|4.92|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10|
1699556|NCT00998985|3123664|Superiority or Other||LSM Difference|4.87|||||2-Sided|90.0|4.3|5.44|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10|
1699557|NCT00998985|3123664|Superiority or Other||LSM Difference|4.68|||||2-Sided|90.0|4.11|5.25|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10|
1699558|NCT00998985|3123664|Superiority or Other||Least Squares Mean (LSM) Difference|3.46|||||2-Sided|90.0|2.89|4.03|||||LSM Difference (grazoprevir-placebo) and confidence intervals from ANOVA model with maximum log10 HCV reduction as response and a fixed effect for treatment.|It is hypothesized that one or more doses of Grazoprevir will reduce GT1 viral load by at least 3 log10|
1699559|NCT00998764|3123681|Superiority or Other||Mean Difference (Final Values)|0.26||||0.603|2-Sided|95.0|-0.73|1.26|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 78.|
1699560|NCT00998764|3123681|Superiority or Other||Mean Difference (Final Values)|0.52||||0.16|2-Sided|95.0|-0.21|1.25|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 45.|
1699561|NCT00998764|3123681|Superiority or Other||Mean Difference (Final Values)|0.45||||0.152|2-Sided|95.0|-0.17|1.08|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 32.|
1699562|NCT00998764|3123681|Superiority or Other||Mean Difference (Final Values)|0.47||||0.089|2-Sided|95.0|-0.07|1.01|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 19.|
1699563|NCT00998764|3123681|Superiority or Other||Mean Difference (Final Values)|0.41||||0.099|2-Sided|95.0|-0.08|0.9|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 6.|
1699564|NCT00998764|3123682|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.922|2-Sided|95.0|-0.85|0.77|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 78.|
1699565|NCT00998764|3123682|Superiority or Other||Mean Difference (Final Values)|0.18||||0.598|2-Sided|95.0|-0.48|0.83|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 45.|
1699566|NCT00998764|3123682|Superiority or Other||Mean Difference (Final Values)|0.1||||0.742|2-Sided|95.0|-0.51|0.72|||Mixed Models Analysis|||Change from extension study baseline in MMSE score at Week 32.|
1699567|NCT00998764|3123682|Superiority or Other||Mean Difference (Final Values)|0.12||||0.681|2-Sided|95.0|-0.45|0.69|||Mixed Models Analysis|||Change from base study baseline in MMSE score at Week 19.|
1699568|NCT00998764|3123682|Superiority or Other||Mean Difference (Final Values)|0.07||||0.811|2-Sided|95.0|-0.49|0.63|||Mixed Models Analysis|||Change from base study baseline in MMSE score at Week 6.|
1699569|NCT00998764|3123683|Superiority or Other||Mean Difference (Final Values)|-3.32||||0.128|2-Sided|95.0|-7.6|0.96|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 78.|
1699570|NCT00998764|3123683|Superiority or Other||Mean Difference (Final Values)|-1.84||||0.137|2-Sided|95.0|-4.28|0.59|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 52.|
1699571|NCT00998764|3123683|Superiority or Other||Mean Difference (Final Values)|-0.71||||0.531|2-Sided|95.0|-2.92|1.51|||Mixed Models Analysis|||Change from extension study baseline in NPI score at week 26.|
1699572|NCT00998764|3123684|Superiority or Other||Mean Difference (Final Values)|-2.03||||0.353|2-Sided|95.0|-6.32|2.27|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 78.|
1699573|NCT00998764|3123684|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.524|2-Sided|95.0|-3.26|1.67|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 52.|
1699574|NCT00998764|3123684|Superiority or Other||Mean Difference (Final Values)|0.11||||0.931|2-Sided|95.0|-2.4|2.62|||Mixed Models Analysis|||Change from base study baseline in NPI score at week 26.|
1699575|NCT00998764|3123685|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.954|2-Sided|95.0|-5.05|4.77|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 78|
1699576|NCT00998764|3123685|Superiority or Other||Mean Difference (Final Values)|0.71||||0.68|2-Sided|95.0|-2.7|4.13|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 52|
1699577|NCT00998764|3123685|Superiority or Other||Mean Difference (Final Values)|-1.55||||0.328|2-Sided|95.0|-4.67|1.56|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 39|
1699578|NCT00998764|3123685|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.601|2-Sided|95.0|-3.31|1.92|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 26|
1699579|NCT00998764|3123685|Superiority or Other||Mean Difference (Final Values)|-1.08||||0.329|2-Sided|95.0|-3.24|1.09|||Mixed Models Analysis|||Change from extension study baseline in DAD score at Week 13|
1699580|NCT00998764|3123686|Superiority or Other||Mean Difference (Final Values)|-2.78||||0.321|2-Sided|95.0|-8.28|2.73|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 78|
1699581|NCT00998764|3123686|Superiority or Other||Mean Difference (Final Values)|-1.75||||0.412|2-Sided|95.0|-5.95|2.44|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 52|
1699582|NCT00998764|3123686|Superiority or Other||Mean Difference (Final Values)|-3.6||||0.063|2-Sided|95.0|-7.38|0.19|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 39|
1699583|NCT00998764|3123686|Superiority or Other||Mean Difference (Final Values)|-2.67||||0.117|2-Sided|95.0|-6.02|0.67|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 26|
1699584|NCT00998764|3123686|Superiority or Other||Mean Difference (Final Values)|-2.99||||0.077|2-Sided|95.0|-6.3|0.33|||Mixed Models Analysis|||Change from base study baseline in DAD score at Week 13|
1699585|NCT00998764|3123687|Superiority or Other||Mean Difference (Final Values)|-2.13||||0.044|2-Sided|95.0|-4.21|0.06|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 78|
1699586|NCT00998764|3123687|Superiority or Other||Mean Difference (Final Values)|-0.91||||0.197|2-Sided|95.0|-2.3|0.48|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 52|
1699587|NCT00998764|3123687|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.168|2-Sided|95.0|-2.19|0.38|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 39|
1699588|NCT00998764|3123687|Superiority or Other||Mean Difference (Final Values)|-0.68||||0.213|2-Sided|95.0|-1.76|0.4|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 26|
1699589|NCT00998764|3123687|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.737|2-Sided|95.0|-1.11|0.79|||Mixed Models Analysis|||Change from extension study baseline in ADAS-Cog at week 13|
1699590|NCT00998764|3123688|Superiority or Other||Mean Difference (Final Values)|-1.21||||0.336|2-Sided|95.0|-3.67|1.26|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 78|
1699591|NCT00998764|3123688|Superiority or Other||Mean Difference (Final Values)|0.0||||0.996|2-Sided|95.0|-1.93|1.92|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 52|
1699592|NCT00998764|3123688|Superiority or Other||Mean Difference (Final Values)|0.04||||0.966|2-Sided|95.0|-1.81|1.89|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 39|
1699593|NCT00998764|3123688|Superiority or Other||Mean Difference (Final Values)|0.29||||0.723|2-Sided|95.0|-1.33|1.92|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 26|
1699594|NCT00998764|3123688|Superiority or Other||Mean Difference (Final Values)|0.74||||0.324|2-Sided|95.0|-0.74|2.23|||Mixed Models Analysis|||Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 13|
1699595|NCT00998426|3123709|Superiority or Other|||||||0.59||||||This is the p value for the meter by time interaction|Random intercept model|||A random intercept model was used to fit the five subjects' glucose reading data over time. The fixed effect glucose meters, time effect and their interactions were included in the model.|
1699596|NCT00998400|3123710|Superiority||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.|||
1699597|NCT00998400|3123711|Superiority||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.|||
1699598|NCT00998400|3123712|Superiority||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.|||
1699599|NCT00998400|3123713|Superiority||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.|||
1699600|NCT00998400|3123714|Superiority||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.|||
1699601|NCT00998400|3123715|Superiority|||||||0.013|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.|||
1699602|NCT00998400|3123716|Superiority||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.|||
1699603|NCT00998400|3123717|Superiority||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.|||
1699604|NCT00998400|3123718|Superiority||||||>|0.05|||||||Kaplan-Meier Survival analysis||||
1699605|NCT00998400|3123719|Superiority||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.|||
1699606|NCT00998400|3123720|Superiority||||||>|0.05|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.|||
1699607|NCT00998400|3123721|Superiority|||||||0.03|||||||Repeated Measures ANOVA|All analyses were performed by using intention-to-treat (ITT) analysis, where missing values were managed by means of multiple imputations procedure.|||
1699608|NCT00998335|3123737|Superiority or Other|||||||0.03|||||||ANOVA|||Baseline versus 3 months|
1699609|NCT00998309|3123738|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Pregnancy in Female. The null hypothesis is there is no difference between with and without Pregnancy in the Incidence Rate of Treatment Related Adverse Events (TRAEs) in Female."|
1699610|NCT00998309|3123739|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."|
1699611|NCT00998309|3123740|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."|
1699612|NCT00998309|3123741|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was previous antibiotic treatment history (PATH). The null hypothesis is there is no difference between with and without previous antibiotic treatment history (PTH) in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."|
1699613|NCT00998309|3123742|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."|
1699614|NCT00998309|3123743|Superiority or Other||||||<|0.001|||||||Fisher Exact|||"The risk factor tested was Past Medical History. The null hypothesis is there is no difference between with and without Past Medical History in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."|
1699615|NCT00998309|3123744|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Renal Dysfunction. The null hypothesis is there is no difference between with and without Renal Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."|
1699616|NCT00998309|3123745|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Hepatic Dysfunction. The null hypothesis is there is no difference between with and without Hepatic Dysfunction in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."|
1699688|NCT00996996|3123957|Superiority or Other||Percentage of participants|3.0|||||2-Sided|95.0|0.0|6.0|||||The estimated value represents the percentage of participants with a confirmed CCR.||
1699617|NCT00998309|3123746|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, or severe infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."|
1699618|NCT00998309|3123747|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Type of Infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental or Oral Surgery Infection in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."|
1699619|NCT00998309|3123748|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between <65 years or >=65 in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."|
1699620|NCT00998309|3123749|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the Incidence Rate of Treatment Related Adverse Events (TRAEs)."|
1699621|NCT00998309|3123752|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was non-drug therapy. The null hypothesis is there is no difference between with and without non-drug therapy in the participatns of responders."|
1699622|NCT00998309|3123753|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was comcomittant drugs. The null hypothesis is there is no difference between with and without comcomittant drugs in the participatns of responders."|
1699623|NCT00998309|3123754|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was previous antibiotic treatment history. The null hypothesis is there is no difference between with and without previous antibiotic treatment history in the participatns of responders."|
1699624|NCT00998309|3123755|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications  in the participatns of responders."|
1699625|NCT00998309|3123756|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Past medical history. The null hypothesis is there is no difference between with and without past medical history in the participatns of responders."|
1699626|NCT00998309|3123757|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Renal dysfunction. The null hypothesis is there is no difference between with and without Renal dysfunction in the participatns of responders."|
1699627|NCT00998309|3123758|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was hepatic dysfunction. The null hypothesis is there is no difference between with and without hepatic dysfunction in the participatns of responders."|
1699628|NCT00998309|3123759|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Infection severity. The null hypothesis is there is no difference amang mild infection, moderate infection, and severe infection in the participatns of responders."|
1699629|NCT00998309|3123760|Superiority or Other||||||<|0.001|||||||Fisher Exact|||"The risk factor tested was type of infection. The null hypothesis is there is no difference amang Skin and Soft Tissue Infection, Sexual Transmitted Infection, and Dental and Oral Surgery Infection in the participatns of responders."|
1699630|NCT00998309|3123761|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between <65 years and >=65 years  in the participatns of responders."|
1699631|NCT00998309|3123762|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the participatns of responders."|
1699632|NCT00997984|3123790|Superiority or Other|||||||0.001||||||No formal adjustment for multiplicity was done.|ANCOVA||||
1699633|NCT00997984|3123790|Superiority or Other|||||||0.004||||||No formal adjustment for multiplicity was done.|ANCOVA||||
1699634|NCT00997984|3123790|Superiority or Other||||||<|0.001||||||No formal adjustment for multiplicity was done.|ANCOVA||||
1699635|NCT00997984|3123791|Superiority or Other|||||||0.739||||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel||||
1699636|NCT00997984|3123791|Superiority or Other|||||||0.527||||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel||||
1699637|NCT00997984|3123791|Superiority or Other|||||||0.859||||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel||||
1699638|NCT00997984|3123792|Superiority or Other|||||||0.226||||||No formal adjustment for multiplicity was done.|ANCOVA||||
1699639|NCT00997984|3123792|Superiority or Other|||||||0.531||||||No formal adjustment for multiplicity was done.|ANCOVA||||
1699640|NCT00997984|3123792|Superiority or Other|||||||0.712||||||No formal adjustment for multiplicity was done.|ANCOVA||||
1699641|NCT00997984|3123793|Superiority or Other||||||<|0.001||||||No formal adjustment for multiplicity was done.|ANCOVA||||
1699642|NCT00997984|3123793|Superiority or Other||||||<|0.001||||||No formal adjustment for multiplicity was done.|ANCOVA||||
1699643|NCT00997984|3123793|Superiority or Other||||||<|0.001||||||No formal adjustment for multiplicity was done.|ANCOVA||||
1699644|NCT00997984|3123795|Superiority or Other|||||||0.023||||||No formal adjustment for multiplicity was done.|ANCOVA||||
1699645|NCT00997984|3123795|Superiority or Other|||||||0.596||||||No formal adjustment for multiplicity was done.|ANCOVA||||
1699646|NCT00997984|3123795|Superiority or Other|||||||0.099||||||No formal adjustment for multiplicity was done.|ANCOVA||||
1699647|NCT00997984|3123796|Superiority or Other||||||<|0.001||||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel||||
1699648|NCT00997984|3123796|Superiority or Other||||||<|0.001||||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel||||
1699649|NCT00997984|3123796|Superiority or Other||||||<|0.001||||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel||||
1699650|NCT00997984|3123797|Superiority or Other||||||<|0.001||||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel||||
1699651|NCT00997984|3123797|Superiority or Other||||||<|0.001||||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel||||
1699652|NCT00997984|3123797|Superiority or Other||||||<|0.001||||||No formal adjustment for multiplicity was done.|Cochran-Mantel-Haenszel||||
1699653|NCT00997984|3123798|Superiority or Other||||||<|0.001||||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.|
1699654|NCT00997984|3123798|Superiority or Other||||||<|0.001||||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.|
1699655|NCT00997984|3123798|Superiority or Other||||||<|0.001||||||A hierarchical testing structure was employed. First placebo vs all-active, then placebo vs am and lastly placebo vs pm. Testing was stopped when one comparison was not significant (p<0.05).|ANCOVA|||Study designed to detect an effect size of 0.4 with 90% at the 0.05 significance level.|
1699656|NCT00997620|3123814|Other||Mean Difference (Net)|0.5|||<|0.05|2-Sided||||||t-test, 2 sided|||The statistical analysis was of t testing of the difference of the mean between the baseline and after two weeks. The power analysis was prior to data collection was not performed for this test. The null hypothesis is no different, no difference between placebo and active treatment.|
1699657|NCT00997594|3123818|Non-Inferiority or Equivalence|Just a comparison of the percentage of hypertension between the 2 patient groups.|||||<|0.05|||||||Chi-squared, Corrected||||
1699658|NCT00997555|3123822|Superiority or Other|||||||0.5|||||||t-test, 2 sided|(bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5).|||
1699659|NCT00997555|3123823|Superiority or Other|||||||0.4|||||||t-test, 2 sided|(bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4).|||
1699660|NCT00997555|3123824|Superiority or Other|||||||0.7||||||(bronchoscopy 5.1 days, 95% CI +/- 3.6 days versus control 6.7 days, 95% CI +/- 6.3 days, p = 0.7).|t-test, 2 sided||||
1699661|NCT00997555|3123825|Superiority or Other|||||||0.6|||||||Chi-squared||||
1699662|NCT00997516|3123828|Superiority or Other||||||<|0.01||||||Significant at p<0.05|t-test, 2 sided|||Overall impression of scars|
1699663|NCT00997516|3123828|Superiority or Other||||||<|0.81||||||Significant at p<0.05|t-test, 2 sided|||Discomfort of scars|
1699664|NCT00997516|3123828|Superiority or Other||||||<|0.25||||||Significant at p<0.05|t-test, 2 sided|||Satisfaction with scars|
1699665|NCT00997516|3123828|Superiority or Other||||||<|0.09||||||Significant at p<0.05|t-test, 2 sided|||Cosmetic appearance of scars|
1699666|NCT00997516|3123828|Superiority or Other||||||<|0.48||||||Significant at p<0.05|t-test, 2 sided|||Cosmetic appearance of abdomen|
1699667|NCT00997516|3123829|Superiority or Other|||||||0.63||||||Significant at p<0.05|Wilcoxon (Mann-Whitney)|||Looking at oneself naked|
1699668|NCT00997516|3123829|Superiority or Other|||||||0.34||||||Significant at p<0.05|Wilcoxon (Mann-Whitney)|||Masculinity/femininity|
1699669|NCT00997516|3123829|Superiority or Other|||||||0.04||||||Significant at p<0.05|Wilcoxon (Mann-Whitney)|||Physical attractiveness|
1699670|NCT00997516|3123829|Superiority or Other|||||||0.18||||||Significant at p<0.05|Wilcoxon (Mann-Whitney)|||Damage to body|
1699671|NCT00997516|3123829|Superiority or Other|||||||0.86||||||Significant at p<0.05|Wilcoxon (Mann-Whitney)|||Overall body satisfaction|
1699672|NCT00997516|3123838|Superiority or Other||||||<|0.01||||||Significant at p<0.05|t-test, 2 sided||||
1699673|NCT00997516|3123839|Superiority or Other|||||||0.01||||||Significant at p<0.05|Wilcoxon (Mann-Whitney)||||
1699674|NCT00997425|3123887|Superiority or Other|||||||0.045||||||P values above 0.05 are considered statistically not significant in this study|paired t-test|statistical analysis applies to door pass through behavior|||
1699675|NCT00997425|3123887|Superiority or Other|||||||0.098||||||values above 0.05 are considered statistically not significant in this study|paired t-test|statistical analysis applies to door approach behavior|||
1699676|NCT00997373|3123892|Superiority or Other|||||||0.0373|||||||Fisher Exact||||
1699677|NCT00997126|3123913|Superiority or Other|||||||0.657|||||||Chi-squared||||
1699678|NCT00997113|3123920|Superiority or Other|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||Comparison of the change in serum catecholamines from one minute before the procedure to one minute after. In order to detect a 20% difference in mean catecholamine values between groups, assuming a 30% standard deviation, with an alpha of 0.05 and a beta of 0.2 (80% power), power analysis indicated that 10 patients per group were required.|
1699679|NCT00997035|3123923|Superiority||||||<|0.001||||||Statistically significant after Holms-Šidák correction for multiple comparisons.|Fisher Exact||||
1699680|NCT00997035|3123925|Superiority||Hazard Ratio (HR)|0.87||||0.65|2-Sided|95.0|0.49|1.57|||Regression, Cox||||
1699681|NCT00997035|3123930|Superiority||Hazard Ratio (HR)|0.82||||0.29|2-Sided|95.0|0.57|1.18|||Regression, Cox|Cox proportional hazards regression to estimate the hazard of perforation or need for TPK.||The sample size was determined based on the primary end point: perforation or the need for TPK within 3 months. Simulation-based analyses estimated that a sample sizeof 240 study participants (120 per arm) would provide 80% power to detect a 15% difference in the 3-month perforation or need for TPK rate between topical antifungal plus oral voriconazole vs topical antifungal alone,with a 2-tailed α value of .05 and approximately 15%loss to follow-up.|
1699682|NCT00996996|3123956|Superiority or Other||Percentage of participants|20.0|||||2-Sided|95.0|11.0|29.0|||||The estimated value represents the percentage of participants with a PR.||
1699683|NCT00996996|3123956|Superiority or Other||Percentage of participants|78.0|||||2-Sided|95.0|68.0|87.0|||||The estimated value represents the percentage of participants with a CR + CCR.||
1699684|NCT00996996|3123956|Superiority or Other||Percentage of participants|4.0|||||2-Sided|95.0|0.0|8.0|||||The estimated value represents the percentage of participants with a CCR.||
1699685|NCT00996996|3123956|Superiority or Other||Percentage of participants|74.0|||||2-Sided|95.0|64.0|84.0|||||The estimated value represents the percentage of participants with a CR.||
1699686|NCT00996996|3123957|Superiority or Other||Percentage of participants|17.0|||||2-Sided|95.0|9.0|26.0|||||The estimated value represents the percentage of participants with a confirmed PR.||
1699687|NCT00996996|3123957|Superiority or Other||Percentage of participants|75.0|||||2-Sided|95.0|65.0|85.0|||||The estimated value represents the percentage of participants with confirmed CR + confirmed CCR.||
1699689|NCT00996996|3123957|Superiority or Other||Percentage of participants|70.0|||||2-Sided|95.0|59.0|80.0|||||The estimated value represents the percentage of participants with a confirmed CR.||
1699690|NCT00996996|3123958|Superiority or Other||Percentage of participants|97.0|||||2-Sided|95.0|94.0|100.0|||||The estimated value represents the percentage of participants with a response.||
1699691|NCT00996996|3123959|Superiority or Other||Percentage of participants|95.0|||||2-Sided|95.0|90.0|100.0|||||The estimated value represents the percentage of participants with a confirmed response.||
1699692|NCT00996918|3123981|Superiority or Other||Mean Difference (Final Values)|1.75||||0.066|2-Sided|95.0|-0.12|3.62|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699693|NCT00996918|3123981|Superiority or Other||Mean Difference (Final Values)|2.45||||0.006|2-Sided|95.0|0.69|4.22|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699694|NCT00996918|3123981|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.756|2-Sided|95.0|-1.7|1.24|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 45.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699695|NCT00996918|3123981|Superiority or Other||Mean Difference (Final Values)|0.93||||0.198|2-Sided|95.0|-0.49|2.34|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 45.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699696|NCT00996918|3123981|Superiority or Other||Mean Difference (Final Values)|0.25||||0.713|2-Sided|95.0|-1.09|1.6|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 32.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699697|NCT00996918|3123981|Superiority or Other||Mean Difference (Final Values)|0.66||||0.303|2-Sided|95.0|-0.59|1.9|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 32.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699698|NCT00996918|3123981|Superiority or Other||Mean Difference (Final Values)|-0.69||||0.288|2-Sided|95.0|-1.97|0.59|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 19.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699699|NCT00996918|3123981|Superiority or Other||Mean Difference (Final Values)|0.47||||0.441|2-Sided|95.0|-0.72|1.65|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 19.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699700|NCT00996918|3123981|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.592|2-Sided|95.0|-1.58|0.9|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 6.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699701|NCT00996918|3123981|Superiority or Other||Mean Difference (Final Values)|0.4||||0.504|2-Sided|95.0|-0.77|1.57|||Mixed Models Analysis|||"Change from extension study baseline in MMSE score at Week 6.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699702|NCT00996918|3123982|Superiority or Other||Mean Difference (Final Values)|2.09||||0.026|2-Sided|95.0|0.25|3.93|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699703|NCT00996918|3123982|Superiority or Other||Mean Difference (Final Values)|2.52||||0.004|2-Sided|95.0|0.79|4.26|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699788|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.951|Standard Error of the Mean|0.143|||2-Sided|95.0|0.715|1.266||||||Comparison at 24 h post first dose|
1699789|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|1.08|Standard Error of the Mean|0.157|||2-Sided|95.0|0.79|1.478||||||Comparison at 18 h post first dose|
1699704|NCT00996918|3123982|Superiority or Other||Mean Difference (Final Values)|0.12||||0.872|2-Sided|95.0|-1.34|1.57|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 45.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699705|NCT00996918|3123982|Superiority or Other||Mean Difference (Final Values)|0.73||||0.309|2-Sided|95.0|-0.67|2.12|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 45.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699706|NCT00996918|3123982|Superiority or Other||Mean Difference (Final Values)|0.52||||0.445|2-Sided|95.0|-0.82|1.86|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 32.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699707|NCT00996918|3123982|Superiority or Other||Mean Difference (Final Values)|0.39||||0.535|2-Sided|95.0|-0.85|1.63|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 32.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699708|NCT00996918|3123982|Superiority or Other||Mean Difference (Final Values)|-0.52||||0.421|2-Sided|95.0|-1.8|0.75|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 19.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699709|NCT00996918|3123982|Superiority or Other||Mean Difference (Final Values)|0.15||||0.809|2-Sided|95.0|-1.04|1.33|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 19.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699710|NCT00996918|3123982|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.753|2-Sided|95.0|-1.43|1.04|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 6.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699711|NCT00996918|3123982|Superiority or Other||Mean Difference (Final Values)|0.05||||0.938|2-Sided|95.0|-1.12|1.21|||Mixed Models Analysis|||"Change from base study baseline in MMSE score at Week 6.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699712|NCT00996918|3123983|Superiority or Other||Mean Difference (Final Values)|2.48||||0.732|2-Sided|95.0|-11.97|16.94|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699713|NCT00996918|3123983|Superiority or Other||Mean Difference (Final Values)|-10.06||||0.13|2-Sided|95.0|-23.16|3.05|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699714|NCT00996918|3123983|Superiority or Other||Mean Difference (Final Values)|0.21||||0.95|2-Sided|95.0|-6.34|6.76|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699715|NCT00996918|3123983|Superiority or Other||Mean Difference (Final Values)|-3.4||||0.28|2-Sided|95.0|-9.61|2.8|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699716|NCT00996918|3123983|Superiority or Other||Mean Difference (Final Values)|-1.03||||0.677|2-Sided|95.0|-5.92|3.86|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699717|NCT00996918|3123983|Superiority or Other||Mean Difference (Final Values)|-2.08||||0.373|2-Sided|95.0|-6.68|2.52|||Mixed Models Analysis|||"Change from extension study baseline in NPI score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699718|NCT00996918|3123984|Superiority or Other||Mean Difference (Final Values)|1.47||||0.76|2-Sided|95.0|-7.95|10.88|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699719|NCT00996918|3123984|Superiority or Other||Mean Difference (Final Values)|-12.86||||0.003|2-Sided|95.0|-21.46|-4.25|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699720|NCT00996918|3123984|Superiority or Other||Mean Difference (Final Values)|2.34||||0.505|2-Sided|95.0|-4.55|9.22|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699721|NCT00996918|3123984|Superiority or Other||Mean Difference (Final Values)|-4.99||||0.133|2-Sided|95.0|-11.52|1.53|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699722|NCT00996918|3123984|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.92|2-Sided|95.0|-5.92|5.35|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699723|NCT00996918|3123984|Superiority or Other||Mean Difference (Final Values)|-3.6||||0.183|2-Sided|95.0|-8.91|1.71|||Mixed Models Analysis|||"Change from base study baseline in NPI score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699724|NCT00996918|3123985|Superiority or Other||Mean Difference (Final Values)|-2.87||||0.501|2-Sided|95.0|-11.24|5.5|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699725|NCT00996918|3123985|Superiority or Other||Mean Difference (Final Values)|2.09||||0.597|2-Sided|95.0|-5.67|9.86|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699726|NCT00996918|3123985|Superiority or Other||Mean Difference (Final Values)|-1.04||||0.76|2-Sided|95.0|-7.77|5.68|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699727|NCT00996918|3123985|Superiority or Other||Mean Difference (Final Values)|2.44||||0.458|2-Sided|95.0|-4.01|8.89|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699728|NCT00996918|3123985|Superiority or Other||Mean Difference (Final Values)|-2.74||||0.368|2-Sided|95.0|-8.73|3.24|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699729|NCT00996918|3123985|Superiority or Other||Mean Difference (Final Values)|-2.35||||0.409|2-Sided|95.0|-7.95|3.24|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699730|NCT00996918|3123985|Superiority or Other||Mean Difference (Final Values)|-1.5||||0.595|2-Sided|95.0|-7.06|4.05|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699731|NCT00996918|3123985|Superiority or Other||Mean Difference (Final Values)|-0.89||||0.734|2-Sided|95.0|-6.03|4.25|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699732|NCT00996918|3123985|Superiority or Other||Mean Difference (Final Values)|3.69||||0.177|2-Sided|95.0|-1.68|9.06|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699733|NCT00996918|3123985|Superiority or Other||Mean Difference (Final Values)|-1.03||||0.683|2-Sided|95.0|-6.01|3.95|||Mixed Models Analysis|||"Change from extension study baseline in DAD score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699734|NCT00996918|3123986|Superiority or Other||Mean Difference (Final Values)|-5.07||||0.43|2-Sided|95.0|-17.75|7.61|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699735|NCT00996918|3123986|Superiority or Other||Mean Difference (Final Values)|0.73||||0.902|2-Sided|95.0|-11.04|12.5|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699736|NCT00996918|3123986|Superiority or Other||Mean Difference (Final Values)|-2.81||||0.55|2-Sided|95.0|-12.06|6.45|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699737|NCT00996918|3123986|Superiority or Other||Mean Difference (Final Values)|1.53||||0.733|2-Sided|95.0|-7.28|10.33|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699738|NCT00996918|3123986|Superiority or Other||Mean Difference (Final Values)|-4.53||||0.293|2-Sided|95.0|-13.02|3.95|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699739|NCT00996918|3123986|Superiority or Other||Mean Difference (Final Values)|-1.95||||0.63|2-Sided|95.0|-9.91|6.02|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699740|NCT00996918|3123986|Superiority or Other||Mean Difference (Final Values)|-2.92||||0.473|2-Sided|95.0|-10.92|5.08|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699741|NCT00996918|3123986|Superiority or Other||Mean Difference (Final Values)|0.15||||0.968|2-Sided|95.0|-7.32|7.62|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699742|NCT00996918|3123986|Superiority or Other||Mean Difference (Final Values)|2.13||||0.593|2-Sided|95.0|-5.72|9.98|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699743|NCT00996918|3123986|Superiority or Other||Mean Difference (Final Values)|0.16||||0.967|2-Sided|95.0|-7.22|7.53|||Mixed Models Analysis|||"Change from base study baseline in DAD score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699744|NCT00996918|3123987|Superiority or Other||Mean Difference (Final Values)|0.82||||0.751|2-Sided|95.0|-4.32|5.96|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699745|NCT00996918|3123987|Superiority or Other||Mean Difference (Final Values)|-0.56||||0.816|2-Sided|95.0|-5.35|4.23|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 78.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699746|NCT00996918|3123987|Superiority or Other||Mean Difference (Final Values)|0.12||||0.95|2-Sided|95.0|-3.69|3.93|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699747|NCT00996918|3123987|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.829|2-Sided|95.0|-4.06|3.26|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 52.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699748|NCT00996918|3123987|Superiority or Other||Mean Difference (Final Values)|1.93||||0.158|2-Sided|95.0|-0.76|4.63|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699749|NCT00996918|3123987|Superiority or Other||Mean Difference (Final Values)|0.5||||0.697|2-Sided|95.0|-2.04|3.05|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 39.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699750|NCT00996918|3123987|Superiority or Other||Mean Difference (Final Values)|0.3||||0.817|2-Sided|95.0|-2.22|2.82|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699751|NCT00996918|3123987|Superiority or Other||Mean Difference (Final Values)|0.01||||0.99|2-Sided|95.0|-2.32|2.35|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 26.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699752|NCT00996918|3123987|Superiority or Other||Mean Difference (Final Values)|2.14||||0.064|2-Sided|95.0|-0.13|4.41|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699753|NCT00996918|3123987|Superiority or Other||Mean Difference (Final Values)|0.22||||0.837|2-Sided|95.0|-1.91|2.35|||Mixed Models Analysis|||"Change from extension study baseline in ADAS-Cog score at Week 13.~Results are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699754|NCT00996918|3123988|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.961|2-Sided|95.0|-6.08|5.78|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699755|NCT00996918|3123988|Superiority or Other||Mean Difference (Final Values)|-2.44||||0.384|2-Sided|95.0|-7.97|3.1|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 78.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699756|NCT00996918|3123988|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.922|2-Sided|95.0|-4.73|4.28|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699757|NCT00996918|3123988|Superiority or Other||Mean Difference (Final Values)|-2.05||||0.345|2-Sided|95.0|-6.34|2.24|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 52.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699758|NCT00996918|3123988|Superiority or Other||Mean Difference (Final Values)|1.58||||0.392|2-Sided|95.0|-2.05|5.2|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699790|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|1.072|Standard Error of the Mean|0.138|||2-Sided|95.0|0.814|1.411||||||Comparison at 12 h post first dose|
1699791|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.85|Standard Error of the Mean|0.137|||2-Sided|95.0|0.646|1.119||||||Comparison at 6 h post first dose|
1699759|NCT00996918|3123988|Superiority or Other||Mean Difference (Final Values)|-0.95||||0.584|2-Sided|95.0|-4.37|2.47|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 39.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699760|NCT00996918|3123988|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.981|2-Sided|95.0|-3.5|3.42|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699761|NCT00996918|3123988|Superiority or Other||Mean Difference (Final Values)|-1.51||||0.357|2-Sided|95.0|-4.74|1.72|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 26.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699762|NCT00996918|3123988|Superiority or Other||Mean Difference (Final Values)|1.8||||0.264|2-Sided|95.0|-1.37|4.97|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 13.~Results are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699763|NCT00996918|3123988|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.39|2-Sided|95.0|-4.29|1.68|||Mixed Models Analysis|||"Change from base study baseline in ADAS-Cog score at Week 13.~Results are from a restricted maximum likelihood (REML)-based mixed model for repeated measures (MMRM) with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum."|
1699764|NCT00996840|3124093|Other||Ratio (Treatment/Placebo)|0.86|Standard Error of the Mean|0.133|||2-Sided|95.0|0.659|1.122||||||Comparison at 96 h post first dose|
1699765|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.668|Standard Error of the Mean|0.121|||2-Sided|95.0|0.524|0.851||||||Comparison at 72 h post first dose|
1699766|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.781|Standard Error of the Mean|0.125|||2-Sided|95.0|0.608|1.003||||||Comparison at 48 h post first dose|
1699767|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.761|Standard Error of the Mean|0.106|||2-Sided|95.0|0.615|0.942||||||Comparison at 24 h post first dose|
1699768|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.826|Standard Error of the Mean|0.116|||2-Sided|95.0|0.655|1.042||||||Comparison at 18 h post first dose|
1699769|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.768|Standard Error of the Mean|0.103|||2-Sided|95.0|0.625|0.943||||||Comparison at 12 h post first dose|
1699770|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.923|Standard Error of the Mean|0.102|||2-Sided|95.0|0.753|1.131||||||Comparison at 6 h post first dose|
1699771|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|1.229|Standard Error of the Mean|0.136|||2-Sided|95.0|0.936|1.613||||||Comparison at 96 h post first dose|
1699772|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.926|Standard Error of the Mean|0.127|||2-Sided|95.0|0.718|1.193||||||Comparison at 72 h post first dose|
1699773|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.968|Standard Error of the Mean|0.132|||2-Sided|95.0|0.743|1.262||||||Comparison at 48 h post first dose|
1699774|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.95|Standard Error of the Mean|0.111|||2-Sided|95.0|0.761|1.187||||||Comparison at 24 h post first dose|
1699775|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|1.023|Standard Error of the Mean|0.123|||2-Sided|95.0|0.8|1.307||||||Comparison at 18 h post first dose|
1699776|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.879|Standard Error of the Mean|0.109|||2-Sided|95.0|0.707|1.092||||||Comparison at 12 h post first dose|
1699777|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.833|Standard Error of the Mean|0.107|||2-Sided|95.0|0.672|1.031||||||Comparison at 6 h post first dose|
1699778|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|1.474|Standard Error of the Mean|0.164|||2-Sided|95.0|1.063|2.045||||||Comparison at 96 h post first dose|
1699779|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|1.122|Standard Error of the Mean|0.146|||2-Sided|95.0|0.837|1.505||||||Comparison at 72 h post first dose|
1699780|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|1.141|Standard Error of the Mean|0.153|||2-Sided|95.0|0.84|1.55||||||Comparison at 48 h post first dose|
1699781|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.87|Standard Error of the Mean|0.128|||2-Sided|95.0|0.673|1.123||||||Comparison at 24 h post first dose|
1699782|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.917|Standard Error of the Mean|0.14|||2-Sided|95.0|0.693|1.214||||||Comparison at 18 h post first dose|
1699783|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.963|Standard Error of the Mean|0.123|||2-Sided|95.0|0.753|1.233||||||Comparison at 12 h post first dose|
1699784|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.912|Standard Error of the Mean|0.124|||2-Sided|95.0|0.713|1.167||||||Comparison at 6 h post first dose|
1699785|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|1.168|Standard Error of the Mean|0.169|||2-Sided|95.0|0.831|1.64||||||Comparison at 96 h post first dose|
1699786|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|1.012|Standard Error of the Mean|0.16|||2-Sided|95.0|0.735|1.395||||||Comparison at 72 h post first dose|
1699787|NCT00996840|3124093|Superiority or Other||Ratio (Treatment/Placebo)|0.918|Standard Error of the Mean|0.168|||2-Sided|95.0|0.655|1.285||||||Comparison at 48 h post first dose|
1699792|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.451|Standard Error of the Mean|0.23|||2-Sided|95.0|0.285|0.714||||||Comparison at 96 h post first dose|
1699793|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.439|Standard Error of the Mean|0.188|||2-Sided|95.0|0.301|0.639||||||Comparison at 72 h post first dose|
1699794|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.58|Standard Error of the Mean|0.194|||2-Sided|95.0|0.394|0.855||||||Comparison at 48 h post first dose|
1699795|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.812|Standard Error of the Mean|0.145|||2-Sided|95.0|0.609|1.084||||||Comparison at 24 h post first dose|
1699796|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.846|Standard Error of the Mean|0.142|||2-Sided|95.0|0.638|1.123||||||Comparison at 18 h post first dose|
1699797|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.887|Standard Error of the Mean|0.116|||2-Sided|95.0|0.703|1.119||||||Comparison at 12 h post first dose|
1699798|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.897|Standard Error of the Mean|0.091|||2-Sided|95.0|0.748|1.075||||||Comparison at 6 h post first dose|
1699799|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.722|Standard Error of the Mean|0.228|||2-Sided|95.0|0.457|1.14||||||Comparison at 96 h post first dose|
1699800|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.649|Standard Error of the Mean|0.19|||2-Sided|95.0|0.444|0.95||||||Comparison at 72 h post first dose|
1699801|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.866|Standard Error of the Mean|0.198|||2-Sided|95.0|0.583|1.287||||||Comparison at 48 h post first dose|
1699802|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.922|Standard Error of the Mean|0.148|||2-Sided|95.0|0.686|1.239||||||Comparison at 24 h post first dose|
1699803|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|1.067|Standard Error of the Mean|0.146|||2-Sided|95.0|0.797|1.428||||||Comparison at 18 h post first dose|
1699804|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.985|Standard Error of the Mean|0.119|||2-Sided|95.0|0.777|1.249||||||Comparison at 12 h post first dose|
1699805|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.95|Standard Error of the Mean|0.093|||2-Sided|95.0|0.789|1.144||||||Comparison at 6 h post first dose|
1699806|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.724|Standard Error of the Mean|0.268|||2-Sided|95.0|0.423|1.239||||||Comparison at 96 h post first dose|
1699807|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.69|Standard Error of the Mean|0.22|||2-Sided|95.0|0.445|1.072||||||Comparison at 72 h post first dose|
1699808|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.66|Standard Error of the Mean|0.233|||2-Sided|95.0|0.415|1.051||||||Comparison at 48 h post first dose|
1699809|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.913|Standard Error of the Mean|0.171|||2-Sided|95.0|0.649|1.285||||||Comparison at 24 h post first dose|
1699810|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.992|Standard Error of the Mean|0.168|||2-Sided|95.0|0.71|1.387||||||Comparison at 18 h post first dose|
1699811|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.965|Standard Error of the Mean|0.137|||2-Sided|95.0|0.733|1.269||||||Comparison at 12 h post first dose|
1699812|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.952|Standard Error of the Mean|0.107|||2-Sided|95.0|0.768|1.18||||||Comparison at 6 h post first dose|
1699813|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.525|Standard Error of the Mean|0.287|||2-Sided|95.0|0.295|0.935||||||Comparison at 96 h post first dose|
1699814|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.465|Standard Error of the Mean|0.243|||2-Sided|95.0|0.286|0.756||||||Comparison at 72 h post first dose|
1699815|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.662|Standard Error of the Mean|0.255|||2-Sided|95.0|0.397|1.103||||||Comparison at 48 h post first dose|
1699816|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.633|Standard Error of the Mean|0.193|||2-Sided|95.0|0.43|0.931||||||Comparison at 24 h post first dose|
1699817|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.778|Standard Error of the Mean|0.189|||2-Sided|95.0|0.533|1.135||||||Comparison at 18 h post first dose|
1699818|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.795|Standard Error of the Mean|0.155|||2-Sided|95.0|0.583|1.084||||||Comparison at 12 h post first dose|
1699819|NCT00996840|3124094|Superiority or Other||Ratio (Treatment/Placebo)|0.773|Standard Error of the Mean|0.121|||2-Sided|95.0|0.607|0.985||||||Comparison at 6 h post first dose|
1699820|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.744|Standard Error of the Mean|0.251|||2-Sided|95.0|0.45|1.229||||||Comparison at 96 h post first dose|
1699821|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.968|Standard Error of the Mean|0.282|||2-Sided|95.0|0.55|1.701||||||Comparison at 72 h post first dose|
1699822|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.759|Standard Error of the Mean|0.261|||2-Sided|95.0|0.451|1.279||||||Comparison at 48 h post first dose|
1699823|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.657|Standard Error of the Mean|0.222|||2-Sided|95.0|0.421|1.024||||||Comparison at 24 h post first dose|
1699824|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.747|Standard Error of the Mean|0.225|||2-Sided|95.0|0.477|1.171||||||Comparison at 18 h post first dose|
1699825|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.657|Standard Error of the Mean|0.209|||2-Sided|95.0|0.433|0.996||||||Comparison at 12 h post first dose|
1699826|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.58|Standard Error of the Mean|0.163|||2-Sided|95.0|0.419|0.803||||||Comparison at 6 h post first dose|
1699827|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|1.752|Standard Error of the Mean|0.254|||2-Sided|95.0|1.053|2.916||||||Comparison at 96 h post first dose|
1699828|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|1.289|Standard Error of the Mean|0.292|||2-Sided|95.0|0.719|2.312||||||Comparison at 72 h post first dose|
1699829|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|1.23|Standard Error of the Mean|0.27|||2-Sided|95.0|0.716|2.11||||||Comparison at 48 h post first dose|
1699830|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.924|Standard Error of the Mean|0.231|||2-Sided|95.0|0.582|1.467||||||Comparison at 24 h post first dose|
1699831|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.987|Standard Error of the Mean|0.238|||2-Sided|95.0|0.613|1.589||||||Comparison at 18 h post first dose|
1699832|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.83|Standard Error of the Mean|0.216|||2-Sided|95.0|0.539|1.277||||||Comparison at 12 h post first dose|
1699833|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.559|Standard Error of the Mean|0.168|||2-Sided|95.0|0.4|0.783||||||Comparison at 6 h post first dose|
1699834|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|1.375|Standard Error of the Mean|0.313|||2-Sided|95.0|0.735|2.574||||||Comparison at 96 h post first dose|
1699835|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|1.075|Standard Error of the Mean|0.346|||2-Sided|95.0|0.539|2.146||||||Comparison at 72 h post first dose|
1699836|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|1.111|Standard Error of the Mean|0.323|||2-Sided|95.0|0.583|2.12||||||Comparison at 48 h post first dose|
1699837|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.655|Standard Error of the Mean|0.273|||2-Sided|95.0|0.379|1.13||||||Comparison at 24 h post first dose|
1699838|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.725|Standard Error of the Mean|0.277|||2-Sided|95.0|0.417|1.26||||||Comparison at 18 h post first dose|
1699839|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.791|Standard Error of the Mean|0.255|||2-Sided|95.0|0.476|1.317||||||Comparison at 12 h post first dose|
1699840|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.726|Standard Error of the Mean|0.199|||2-Sided|95.0|0.488|1.08||||||Comparison at 6 h post first dose|
1699841|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.905|Standard Error of the Mean|0.321|||2-Sided|95.0|0.476|1.723||||||Comparison at 96 h post first dose|
1699842|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.944|Standard Error of the Mean|0.376|||2-Sided|95.0|0.445|2.002||||||Comparison at 72 h post first dose|
1699843|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.92|Standard Error of the Mean|0.351|||2-Sided|95.0|0.456|1.857||||||Comparison at 48 h post first dose|
1699844|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.673|Standard Error of the Mean|0.302|||2-Sided|95.0|0.368|1.231||||||Comparison at 24 h post first dose|
1699845|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.681|Standard Error of the Mean|0.305|||2-Sided|95.0|0.37|1.254||||||Comparison at 18 h post first dose|
1699846|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.7|Standard Error of the Mean|0.282|||2-Sided|95.0|0.399|1.229||||||Comparison at 12 h post first dose|
1699847|NCT00996840|3124095|Superiority or Other||Ratio (Treatment/Placebo)|0.484|Standard Error of the Mean|0.219|||2-Sided|95.0|0.312|0.75||||||Comparison at 6 h post first dose|
1699848|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.579|Standard Error of the Mean|0.361|||2-Sided|95.0|0.281|1.192||||||Comparison at 96 h post first dose|
1699849|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.479|Standard Error of the Mean|0.317|||2-Sided|95.0|0.255|0.903||||||Comparison at 72 h post first dose|
1699850|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.502|Standard Error of the Mean|0.259|||2-Sided|95.0|0.299|0.842||||||Comparison at 48 h post first dose|
1699851|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.429|Standard Error of the Mean|0.245|||2-Sided|95.0|0.263|0.7||||||Comparison at 24 h post first dose|
1699852|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.623|Standard Error of the Mean|0.24|||2-Sided|95.0|0.386|1.007||||||Comparison at 18 h post first dose|
1699853|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.602|Standard Error of the Mean|0.212|||2-Sided|95.0|0.394|0.919||||||Comparison at 12 h post first dose|
1699854|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.776|Standard Error of the Mean|0.167|||2-Sided|95.0|0.556|1.082||||||Comparison at 6 h post first dose|
1699855|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|1.147|Standard Error of the Mean|0.359|||2-Sided|95.0|0.559|2.353||||||Comparison at 96 h post first dose|
1699856|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.73|Standard Error of the Mean|0.321|||2-Sided|95.0|0.384|1.386||||||Comparison at 72 h post first dose|
1699857|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.725|Standard Error of the Mean|0.264|||2-Sided|95.0|0.427|1.23||||||Comparison at 48 h post first dose|
1699858|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.558|Standard Error of the Mean|0.251|||2-Sided|95.0|0.338|0.921||||||Comparison at 24 h post first dose|
1699859|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.613|Standard Error of the Mean|0.247|||2-Sided|95.0|0.374|1.004||||||Comparison at 18 h post first dose|
1699860|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.674|Standard Error of the Mean|0.217|||2-Sided|95.0|0.437|1.039||||||Comparison at 12 h post first dose|
1699861|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.608|Standard Error of the Mean|0.17|||2-Sided|95.0|0.433|0.853||||||Comparison at 6 h post first dose|
1699862|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|1.56|Standard Error of the Mean|0.431|||2-Sided|95.0|0.659|3.697||||||Comparison at 96 h post first dose|
1699863|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.739|Standard Error of the Mean|0.374|||2-Sided|95.0|0.35|1.563||||||Comparison at 72 h post first dose|
1699864|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.896|Standard Error of the Mean|0.308|||2-Sided|95.0|0.484|1.657||||||Comparison at 48 h post first dose|
1699865|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.41|Standard Error of the Mean|0.287|||2-Sided|95.0|0.231|0.728||||||Comparison at 24 h post first dose|
1699866|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.578|Standard Error of the Mean|0.282|||2-Sided|95.0|0.329|1.015||||||Comparison at 18 h post first dose|
1699867|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.701|Standard Error of the Mean|0.248|||2-Sided|95.0|0.427|1.15||||||Comparison at 12 h post first dose|
1701528|NCT00968669|3128373|Superiority or Other|||||||0.047|||||||Pairwise Poisson Regression||||
1699868|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.768|Standard Error of the Mean|0.195|||2-Sided|95.0|0.52|1.134||||||Comparison at 6 h post first dose|
1699869|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.908|Standard Error of the Mean|0.454|||2-Sided|95.0|0.366|2.254||||||Comparison at 96 h post first dose|
1699870|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.661|Standard Error of the Mean|0.41|||2-Sided|95.0|0.291|1.503||||||Comparison at 72 h post first dose|
1699871|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.517|Standard Error of the Mean|0.34|||2-Sided|95.0|0.262|1.021||||||Comparison at 48 h post first dose|
1699872|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.416|Standard Error of the Mean|0.326|||2-Sided|95.0|0.217|0.796||||||Comparison at 24 h post first dose|
1699873|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.518|Standard Error of the Mean|0.319|||2-Sided|95.0|0.274|0.981||||||Comparison at 18 h post first dose|
1699874|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.612|Standard Error of the Mean|0.281|||2-Sided|95.0|0.349|1.072||||||Comparison at 12 h post first dose|
1699875|NCT00996840|3124096|Superiority or Other||Ratio (Treatment/Placebo)|0.562|Standard Error of the Mean|0.228|||2-Sided|95.0|0.357|0.885||||||Comparison at 6 h post first dose|
1699876|NCT00996801|3124121|Superiority or Other||Difference in Least Squares Means|22.13||||0.009|2-Sided|95.0|4.47|39.89||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699877|NCT00996801|3124121|Superiority or Other||Difference in Least Mean Squares|20.47||||0.009|2-Sided|95.0|5.96|35.03||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699878|NCT00996801|3124121|Superiority or Other||Difference in Least Squares Means|20.53||||0.009|2-Sided|95.0|5.96|35.03||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699879|NCT00996801|3124121|Superiority or Other||Difference in Least Squares Means|55.47|||<|0.001|2-Sided|95.0|41.19|69.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699880|NCT00996801|3124121|Superiority or Other||Difference in Least Squares Means|53.81|||<|0.001|2-Sided|95.0|41.37|66.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699881|NCT00996801|3124121|Superiority or Other||Difference in Least Squares Means|53.86|||<|0.001|2-Sided|95.0|39.31|68.6||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699882|NCT00996801|3124122|Superiority or Other||Difference in Least Squares Means|95.34|||<|0.001|2-Sided|95.0|60.4|130.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699883|NCT00996801|3124122|Superiority or Other||Difference in Least Squares Means|57.07|||<|0.001|2-Sided|95.0|30.76|83.64||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699884|NCT00996801|3124122|Superiority or Other||Difference in Least Squares Means|58.57|||<|0.001|2-Sided|95.0|29.42|88.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699885|NCT00996801|3124122|Superiority or Other||Difference in Least Squares Means|169.8|||<|0.001|2-Sided|95.0|141.59|199.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699886|NCT00996801|3124122|Superiority or Other||Difference in Least Squares Means|131.53|||<|0.001|2-Sided|95.0|110.7|152.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699887|NCT00996801|3124122|Superiority or Other||Difference in Least Squares Means|133.03|||<|0.001|2-Sided|95.0|110.01|156.75||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699888|NCT00996801|3124122|Superiority or Other||Difference in Least Squares Means|133.03|||<|0.001|2-Sided|95.0|110.01|156.75||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699889|NCT00996801|3124123|Superiority or Other||Difference in Least Squares Means|85.28||||0.002|2-Sided|95.0|26.7|144.63||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699890|NCT00996801|3124123|Superiority or Other||Difference in Least Squares Means|61.27||||0.019|2-Sided|95.0|8.8|114.22||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699891|NCT00996801|3124123|Superiority or Other||Difference in Least Squares Means|48.29||||0.034|2-Sided|95.0|3.75|93.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1701529|NCT00968669|3128373|Superiority or Other|||||||0.756|||||||Pairwise Poisson Regression||||
1699892|NCT00996801|3124123|Superiority or Other||Difference in Least Squares Means|224.3|||<|0.001|2-Sided|95.0|180.19|270.39||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699893|NCT00996801|3124123|Superiority or Other||Difference in Least Squares Means|200.29|||<|0.001|2-Sided|95.0|161.21|240.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699894|NCT00996801|3124123|Superiority or Other||Difference in Least Squares Means|187.31|||<|0.001|2-Sided|95.0|154.44|221.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699895|NCT00996801|3124124|Superiority or Other||Difference in Least Squares Means|43.8||||0.003|2-Sided|95.0|12.85|75.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699896|NCT00996801|3124124|Superiority or Other||Difference in Least Squares Means|18.68||||0.123|2-Sided|95.0|-5.11|42.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699897|NCT00996801|3124124|Superiority or Other||Difference in Least Squares Means|22.87||||0.104|2-Sided|95.0|-3.8|49.68||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699898|NCT00996801|3124124|Superiority or Other||Difference in Least Squares Means|107.26|||<|0.001|2-Sided|95.0|82.03|133.23||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699899|NCT00996801|3124124|Superiority or Other||Difference in Least Squares Means|82.14|||<|0.001|2-Sided|95.0|63.0|101.66||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699900|NCT00996801|3124124|Superiority or Other||Difference in Least Squares Means|86.33|||<|0.001|2-Sided|95.0|64.87|108.29||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Constrained Longitudinal Data Analysis||||
1699901|NCT00996801|3124125|Superiority or Other||Difference in Least Squares Means|-0.26||||0.843|2-Sided|95.0|-1.43|0.92||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699902|NCT00996801|3124125|Superiority or Other||Difference in Least Squares Means|-0.25||||0.843|2-Sided|95.0|-1.27|0.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699903|NCT00996801|3124125|Superiority or Other||Difference in Least Squares Means|-0.58||||0.509|2-Sided|95.0|-1.77|0.6||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699904|NCT00996801|3124125|Superiority or Other||Difference in Least Squares Means|-1.15||||0.053|2-Sided|95.0|-2.19|-0.11||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699905|NCT00996801|3124125|Superiority or Other||Difference in Least Squares Means|-1.14||||0.053|2-Sided|95.0|-2.29|0.01||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699906|NCT00996801|3124125|Superiority or Other||Difference in Least Squares Means|-1.48||||0.01|2-Sided|95.0|-2.66|-0.29||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699907|NCT00996801|3124126|Superiority or Other||Difference in Least Squares Means|0.33||||0.973|2-Sided|95.0|-19.23|19.9||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699908|NCT00996801|3124126|Superiority or Other||Difference in Least Squares Means|15.33||||0.273|2-Sided|95.0|-7.86|38.52||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699909|NCT00996801|3124126|Superiority or Other||Difference in Least Squares Means|-2.74||||0.94|2-Sided|95.0|-23.91|18.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699910|NCT00996801|3124126|Superiority or Other||Difference in Least Squares Means|-13.14||||0.327|2-Sided|95.0|-35.67|9.39||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699911|NCT00996801|3124126|Superiority or Other||Difference in Least Squares Means|1.85||||0.853|2-Sided|95.0|-17.9|21.61||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699985|NCT00996476|3124305|Superiority or Other||Difference in percentage of participants|-27.5|||||2-Sided|95.0|-61.1|9.8|||||PR48 control minus TMC12/PR24|The difference in the percentage of participants between The TMC12/PR24 100 mg treatment group and the PR48 control group|
1699912|NCT00996801|3124126|Superiority or Other||Difference in Least Squares Means|-16.22||||0.227|2-Sided|95.0|-39.15|6.72||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699913|NCT00996801|3124127|Superiority or Other||Difference in Least Squares Means|0.3||||0.759|2-Sided|95.0|-1.6|2.19||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699914|NCT00996801|3124127|Superiority or Other||Difference in Least Squares Means|0.83||||0.7|2-Sided|95.0|-1.39|3.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699915|NCT00996801|3124127|Superiority or Other||Difference in Least Squares Means|0.78||||0.7|2-Sided|95.0|-1.25|2.82||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699916|NCT00996801|3124127|Superiority or Other||Difference in Least Squares Means|-0.96||||0.624|2-Sided|95.0|-3.23|1.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699917|NCT00996801|3124127|Superiority or Other||Difference in Least Squares Means|-0.42||||0.824|2-Sided|95.0|-2.28|1.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699918|NCT00996801|3124127|Superiority or Other||Difference in Least Squares Means|-0.47||||0.824|2-Sided|95.0|-2.5|1.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699919|NCT00996801|3124128|Superiority or Other||Difference in Least Squares Means|-0.01||||0.992|2-Sided|95.0|-1.93|1.9||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699920|NCT00996801|3124128|Superiority or Other||Difference in Least Squares Means|-0.1||||0.992|2-Sided|95.0|-2.21|2.01||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699921|NCT00996801|3124128|Superiority or Other||Difference in Least Squares Means|-0.43||||0.937|2-Sided|95.0|-2.61|1.76||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699922|NCT00996801|3124128|Superiority or Other||Difference in Least Squares Means|-1.57||||0.157|2-Sided|95.0|-3.53|0.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699923|NCT00996801|3124128|Superiority or Other||Difference in Least Squares Means|-1.66||||0.157|2-Sided|95.0|-3.82|0.5||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699924|NCT00996801|3124128|Superiority or Other||Difference in Least Squares Means|-1.99||||0.094|2-Sided|95.0|-4.22|0.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699925|NCT00996801|3124129|Superiority or Other||Difference in Least Squares Means|-1.47||||0.078|2-Sided|95.0|-3.07|0.12||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699926|NCT00996801|3124129|Superiority or Other||Difference in Least Squares Means|-0.37||||0.577|2-Sided|95.0|-1.69|0.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699927|NCT00996801|3124129|Superiority or Other||Difference in Least Squares Means|-0.84||||0.333|2-Sided|95.0|-2.29|0.61||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699928|NCT00996801|3124129|Superiority or Other||Difference in Least Squares Means|-1.1||||0.23|2-Sided|95.0|-2.67|0.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699929|NCT00996801|3124129|Superiority or Other||Difference in Least Squares Means|-0.01||||0.993|2-Sided|95.0|-1.3|1.28||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699930|NCT00996801|3124129|Superiority or Other||Difference in Least Squares Means|-0.47||||0.68|2-Sided|95.0|-1.88|0.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699931|NCT00996801|3124130|Superiority or Other||Difference in Least Squares Means|-0.94||||0.084|2-Sided|95.0|-1.96|0.09||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699932|NCT00996801|3124130|Superiority or Other||Difference in Least Squares Means|-0.52||||0.383|2-Sided|95.0|-1.49|0.45||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699933|NCT00996801|3124130|Superiority or Other||Difference in Least Squares Means|-0.37||||0.383|2-Sided|95.0|-1.21|0.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699934|NCT00996801|3124130|Superiority or Other||Difference in Least Squares Means|-1.92|||<|0.001|2-Sided|95.0|-2.93|-0.91||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699935|NCT00996801|3124130|Superiority or Other||Difference in Least Squares Means|-1.51|||<|0.001|2-Sided|95.0|-2.46|-0.55||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699936|NCT00996801|3124130|Superiority or Other||Difference in Least Squares Means|-1.36|||<|0.001|2-Sided|95.0|-2.18|-0.54||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699937|NCT00996801|3124131|Superiority or Other||Difference in Least Squares Means|-1.22||||0.18|2-Sided|95.0|-2.68|0.23||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699938|NCT00996801|3124131|Superiority or Other||Difference in Least Squares Means|-1.2||||0.18|2-Sided|95.0|-2.81|0.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699939|NCT00996801|3124131|Superiority or Other||Difference in Least Squares Means|-1.27||||0.18|2-Sided|95.0|-2.93|0.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699940|NCT00996801|3124131|Superiority or Other||Difference in Least Squares Means|-3.2|||<|0.001|2-Sided|95.0|-4.66|-1.74||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699941|NCT00996801|3124131|Superiority or Other||Difference in Least Square Means|-3.18|||<|0.001|2-Sided|95.0|-4.78|-1.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699942|NCT00996801|3124131|Superiority or Other||Difference in Least Squares Means|-3.24|||<|0.001|2-Sided|95.0|-4.91|-1.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699943|NCT00996801|3124132|Superiority or Other||Difference in Least Squares Means|-0.59||||0.542|2-Sided|95.0|-1.96|0.79||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699944|NCT00996801|3124132|Superiority or Other||Difference in Least Squares Means|-0.11||||0.857|2-Sided|95.0|-1.3|1.08||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699945|NCT00996801|3124132|Superiority or Other||Difference in Least Squares Means|-0.86||||0.335|2-Sided|95.0|-2.26|0.54||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699946|NCT00996801|3124132|Superiority or Other||Difference in Least Squares Means|-1.76||||0.009|2-Sided|95.0|-3.14|-0.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699947|NCT00996801|3124132|Superiority or Other||Difference in Least Squares Means|-1.29||||0.035|2-Sided|95.0|-2.48|-0.09||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699948|NCT00996801|3124132|Superiority or Other||Difference in Least Squares Means|-2.04||||0.002|2-Sided|95.0|-3.43|-0.64||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699949|NCT00996801|3124133|Superiority or Other||Difference in Least Squares Means|-0.22||||0.699|2-Sided|95.0|-1.32|0.88||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699950|NCT00996801|3124133|Superiority or Other||Difference in Least Squares Means|-0.71||||0.376|2-Sided|95.0|-1.93|0.5||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699951|NCT00996801|3124133|Superiority or Other||Difference in Least Square Means|-0.74||||0.376|2-Sided|95.0|-1.99|0.52||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699952|NCT00996801|3124133|Superiority or Other||Difference in Least Squares Means|-2.12|||<|0.001|2-Sided|95.0|-3.22|-1.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699953|NCT00996801|3124133|Superiority or Other||Difference in Least Squares Means|-2.62|||<|0.001|2-Sided|95.0|-3.83|-1.4||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699954|NCT00996801|3124133|Superiority or Other||Difference in Least Squares Means|-2.64|||<|0.001|2-Sided|95.0|-3.9|-1.38||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699955|NCT00996801|3124134|Superiority or Other||Difference in Least Squares Means|-1.82||||0.019|2-Sided|95.0|-3.23|-0.41||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699956|NCT00996801|3124134|Superiority or Other||Difference in Least Squares Means|-1.81||||0.019|2-Sided|95.0|-3.37|-0.25||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699957|NCT00996801|3124134|Superiority or Other||Difference in Least Squares Means|-1.96||||0.012|2-Sided|95.0|-3.58|-0.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett's test at the primary time point of Month 12, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1699958|NCT00996736|3124142|Non-Inferiority or Equivalence|The pre-specified non-inferiority margin is less than 1.5 lines logMAR acuity. (Adjusted three-month visual acuity confidence bounds for the difference between the voriconazole and natamycin groups which meet or exceed 0.15 logMAR units would not permit noninferiority to be declared.) Note that this design also allows declaration of superiority (2-sided alpha of 0.05, corrected for an interim analysis).|Mean Difference (Net)|-0.18||||0.006|2-Sided|95.0|-0.3|-0.05|||Regression, Linear||||
1699959|NCT00996658|3124143|Superiority or Other||Mean Difference (Final Values)|-6.2||||0.2137||95.0|-16.0|3.6|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre|||
1699960|NCT00996658|3124144|Superiority or Other||Mean Difference (Final Values)|-10.9||||0.021||95.0|-20.2|-1.7|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre|||
1699961|NCT00996658|3124145|Superiority or Other||Mean Difference (Final Values)|-15.7||||0.0006||95.0|-24.5|-6.8|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre|||
1699962|NCT00996658|3124146|Superiority or Other||Mean Difference (Final Values)|-10.4||||0.028||95.0|-19.6|-1.1|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c, baseline FPG, and centre|||
1699963|NCT00996658|3124147|Superiority or Other||Odds Ratio (OR)|2.059||||0.0071|2-Sided|95.0|1.216|3.485|||Regression, Logistic|||Linagliptin vs. Placebo|
1699964|NCT00996658|3124148|Superiority or Other||Odds Ratio (OR)|3.902||||0.0074|2-Sided|95.0|1.44|10.572|||Regression, Logistic|||Linagliptin vs Placebo|
1699965|NCT00996658|3124149|Superiority or Other||Odds Ratio (OR)|2.939||||0.0033|2-Sided|95.0|1.432|6.032|||Regression, Logistic|||Linagliptin vs Placebo|
1699966|NCT00996658|3124150|Superiority or Other||Mean Difference (Final Values)|-0.54|||<|0.0001||95.0|-0.8|-0.29|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre|||
1699967|NCT00996658|3124151|Superiority or Other||Mean Difference (Final Values)|-0.54|||<|0.0001||95.0|-0.79|-0.28|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre|||
1699968|NCT00996658|3124152|Superiority or Other||Mean Difference (Final Values)|-0.41|||<|0.0001||95.0|-0.61|-0.21|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre|||
1699969|NCT00996658|3124153|Superiority or Other||Mean Difference (Final Values)|-0.57|||<|0.0001||95.0|-0.83|-0.31|||ANCOVA|ANCOVA model included terms for treatment, baseline HbA1c and centre|||
1699970|NCT00996632|3124154|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||null hypothesis is that Stay in Hospital Days are not different|
1699971|NCT00996632|3124155|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||null hypothesis is that drainage volumes are not different|
1699972|NCT00996593|3124259|Superiority or Other|||||||0.9|||||||Log Rank||||
1699973|NCT00996593|3124260|Superiority or Other|||||||0.2|||||||Fisher Exact||||
1699974|NCT00996593|3124261|Superiority or Other||Percentage of responders|17.0||||1|2-Sided|95.0|2.0|33.0||Without prior response|Fisher Exact||The estimated value represents the percentage of participants with response.||
1699975|NCT00996593|3124261|Superiority or Other||Percentage of responders|31.0||||1|2-Sided|95.0|9.0|54.0||With prior response|Fisher Exact||The estimated value represents the percentage of participants with response.||
1699976|NCT00996593|3124262|Superiority or Other|||||||0.8|||||||Fisher Exact||||
1699977|NCT00996593|3124263|Superiority or Other||Percentage of responders|70.0||||1|2-Sided|95.0|51.0|88.0||Without prior response|Fisher Exact||The estimated value represents the percentage of participants with response.||
1699978|NCT00996593|3124263|Superiority or Other||Percentage of responders|75.0||||1|2-Sided|95.0|54.0|96.0||With prior response|Fisher Exact||The estimated value represents the percentage of participants with response.||
1699979|NCT00996593|3124268|Superiority or Other||Percentage of participants|28.0|||||2-Sided|95.0|14.0|41.0|||||The estimated value represents the percentage of participants with complete response.||
1699980|NCT00996593|3124269|Superiority or Other||Percentage of participants|38.0|||||2-Sided|95.0|22.0|53.0|||||The estimated value represents the percentage of participants with complete response.||
1699981|NCT00996593|3124270|Superiority or Other||Percentage of participants|23.0|||||2-Sided|95.0|10.0|35.0|||||The estimated value represents the percentage of participants with complete response.||
1699982|NCT00996593|3124271|Superiority or Other||Percentage of participants|65.0|||||2-Sided|95.0|50.0|80.0|||||The estimated value represents the percentage of participants with complete response.||
1699983|NCT00996476|3124305|Superiority or Other||Difference in percentage of participants|-32.3|||||2-Sided|95.0|-66.6|8.3|||||PR48 control minus TMC24/PR24|The difference in the percentage of participants between The TMC24/PR24 100 mg treatment group and the PR48 control group|
1699984|NCT00996476|3124305|Superiority or Other||Difference in percentage of participants|-23.3|||||2-Sided|95.0|-59.9|19.4|||||PR48 control minus TMC24/PR24|The difference in the percentage of participants between The TMC24/PR24 50 mg treatment group and the PR48 control group|
1701530|NCT00968669|3128374|Superiority or Other|||||||0.502|||||||Pairwise Poisson Regression||||
1699986|NCT00996476|3124305|Superiority or Other||Difference in percentage of participants|-24.6|||||2-Sided|95.0|-58.3|11.8|||||PR48 control minus TMC12/PR24|The difference in the percentage of participants between The TMC12/PR24 50 mg treatment group and the PR48 control group|
1699987|NCT00996476|3124310|Superiority or Other||LS Means difference|-2.41|||||2-Sided|95.0|-2.85|-1.98|||||TMC435 100 mg minus PR48 control|Difference in least square (LS) mean change from baseline from the PR48 control group|
1699988|NCT00996476|3124310|Superiority or Other||LS means difference|-2.4|||||2-Sided|95.0|-2.83|-1.97|||||TMC435 50 mg minus PR48 control|Difference in least square (LS) mean change from baseline from the PR48 control group|
1699989|NCT00996437|3124311|Superiority or Other|||||||0.27|||||||Fisher Exact|At each time point, treatment comparison analysis was performed using a Fisher Exact Test.|||
1699990|NCT00996437|3124312|Superiority or Other|||||||0.023||||||P-value corresponds with the 12 week visit treatment comparison|Fisher Exact|At the each time point, treatment comparison analysis was performed using a Fisher Exact test.|||
1699991|NCT00996437|3124314|Superiority or Other|||||||0.04||||||P-value corresponds to the 12 week visit treatment comparison.|Mixed Models Analysis|Treatment comparisons were performed using a longitudinal mixed model adjusting for baseline visual acuity.|||
1699992|NCT00996437|3124315|Superiority or Other|||||||0.87||||||P-value corresponds to the 12 week visit treatment comparison.|GLM with GEE method|Number of subjects with baseline OCT ss=0 and OCT ss>0 and no vitrectomy at follow up. A generalized GLM with GEE was used for treatment comparisons.||Signal strength was analyzed as a composite outcome defined as OCT signal strength > = and no vitrectomy vs. OCT signal strength = 0.|
1699993|NCT00996437|3124316|Superiority or Other||Hazard Ratio (HR)|1.54||||0.05|2-Sided|95.0|1.03|2.3|||Log Rank||||
1699994|NCT00996437|3124317|Superiority or Other|||||||0.01||||||P-value corresponds with recurrent vitreous hemorrhage evaluated on clinical exam between the two treatment arms.|Fisher Exact||||
1699995|NCT00996437|3124318|Superiority or Other||Treatment Difference in Cumulative Prob|4.0||||0.37|2-Sided|95.0|-4.0|13.0|||Log Rank|After adjusting for potential confounding factors, time to vitrectomy remained similar between treatment groups.||The cumulative probabilities of vitrectomy by 16 weeks in each group were computed using the life-table method. Treatment group comparisons were performed using the log-rank test. The treatment difference in cumulative probabilities and 95% confidence interval were reported.|
1699996|NCT00996307|3124334|Superiority or Other||Ratio of GMTs|4.37|||||2-Sided|95.0|3.09|6.19||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.|
1699997|NCT00996307|3124334|Superiority or Other||Ratio of GMTs|7.52|||||2-Sided|95.0|5.3|11.0||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.|
1699998|NCT00996307|3124334|Superiority or Other||Ratio of GMTs|4.55|||||2-Sided|95.0|3.23|6.42||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines|
1699999|NCT00996307|3124334|Superiority or Other||Ratio of GMTs|7.82|||||2-Sided|95.0|5.54|11.0||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 43.|
1700000|NCT00996307|3124334|Superiority or Other||Ratio of GMTs|2.67|||||2-Sided|95.0|1.72|4.13||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.|
1700001|NCT00996307|3124334|Superiority or Other||Ratio of GMTs|4.42|||||2-Sided|95.0|2.85|6.86||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.|
1700002|NCT00996307|3124334|Superiority or Other||Ratio of GMTs|2.21|||||2-Sided|95.0|1.43|3.4||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22.|
1700003|NCT00996307|3124334|Superiority or Other||Ratio of GMTs|3.66|||||2-Sided|95.0|2.37|5.65||||||Superiority of the adjuvanted vaccines against the non-adjuvanted vaccines was to be tested against the margin of 1 on day 22|
1700004|NCT00996307|3124334|Non-Inferiority or Equivalence|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratios of GMTs|4.15|||||2-Sided|95.0|2.86|6.02|||||Ratio of GMTs at Day 43||
1700005|NCT00996307|3124334|Non-Inferiority or Equivalence|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|7.81|||||2-Sided|95.0|5.36|11.0|||||Ratio of GMTs at Day 43||
1700006|NCT00996307|3124334|Non-Inferiority or Equivalence|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.25|||||2-Sided|95.0|2.94|6.15|||||Ratio of GMTs at Day 43||
1700007|NCT00996307|3124334|Non-Inferiority or Equivalence|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|8.01|||||2-Sided|95.0|5.52|12.0|||||Ratio of GMTs at Day 43||
1700008|NCT00996307|3124334|Non-Inferiority or Equivalence|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|2.49|||||2-Sided|95.0|1.56|3.96|||||Ratio of GMTs at Day 22||
1700009|NCT00996307|3124334|Non-Inferiority or Equivalence|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.49|||||2-Sided|95.0|2.8|7.19|||||Ratio of GMTs at Day 22||
1700010|NCT00996307|3124334|Non-Inferiority or Equivalence|The two-sided CIs were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|2.25|||||2-Sided|95.0|1.42|3.56|||||Ratio of GMTs at Day 22||
1700058|NCT00993928|3124546|Superiority or Other (legacy)|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||Comparison of Q6A: Percent change in time to fall back asleep from baseline to week 7.|
1700011|NCT00996307|3124334|Non-Inferiority or Equivalence|The two-sided confidence intervals (CIs) were calculated and assessed for non-inferiority first against the margin of 0.5 (exploratory margin) and in case of success against the margin of 0.667 (based on CBER guidance against the licensed comparator).|Ratio of GMTs|4.06|||||2-Sided|95.0|2.55|6.46|||||Ratio of GMTs at Day 22||
1700012|NCT00996203|3124355|Superiority or Other||||||<|0.001||||||Mean HAQ scores at Baseline Versus Week 24|t-test, 2 sided||||
1700013|NCT00996203|3124357|Superiority or Other||||||<|0.001||||||Baseline Versus Week 24 DAS28 scores|t-test, 2 sided||||
1700014|NCT00996203|3124359|Superiority or Other||||||<|0.001||||||General health at baseline Versus Week 24|t-test, 2 sided||||
1700015|NCT00996203|3124362|Superiority or Other||||||<|0.001||||||EQ-5D scores at Baseline Versus Week 24|t-test, 2 sided||||
1700016|NCT00996034|3124376|Superiority or Other||||||<|0.05|||||||ANOVA|||This is a comparison of scan 1 and scan 2|
1700017|NCT00995722|3124403|Non-Inferiority or Equivalence|Mean Change NEI-VFQ-25 10 item neuro-opthtalmological supplement score baseline to week 16.|Mean Difference (Final Values)|16.98||||0.16|2-Sided|95.0|-9.22|43.17|||ANCOVA||Ranges 0-100, where 100 is normal and an increase in score represents an improvement.|Mean Change NEI-VFQ-25 10 item neuro-opthtalmological supplement score baseline to week 16. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.|
1700018|NCT00995722|3124404|Non-Inferiority or Equivalence|Mean Change in quality if life as measured by the MG-QOL-15 score at the end of Double- Blinded Treatment|Mean Difference (Final Values)|-3.81||||0.15|2-Sided|95.0|-9.37|1.75|||ANCOVA||Ranges from 0-60, where 0 is Normal and a reduction in score represents improvement.|Mean Change in quality if life as measured by the MG-QOL-15 score at the end of Double- Blinded Treatment. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.|
1700019|NCT00995722|3124405|Non-Inferiority or Equivalence|Mean Change in quality of life as measured by the NEI-VFQ-25 at the end of Double- Blinded Treatment|Mean Difference (Net)|6.56||||0.13|2-Sided|95.0|-2.59|15.71|||ANCOVA||Scores ranges fro 0-100 , where 100 is normal and an increase in score represents an improvement|Mean Change in quality of life as measured by the NEI-VFQ-25 at the end of Double- Blinded Treatment. 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.|
1700020|NCT00995722|3124406|Non-Inferiority or Equivalence|N=80, (40 per group), 80% power to detect a group difference of 30%–35% and 5% significance level.|Mean Difference (Final Values)|-2.2||||0.37|2-Sided|95.0|-7.2|2.8|||ANCOVA|ANCOVA used to compare mean values adjusting for the baseline value|QMG Score ranges from 0-15, where 0 is normal and a reduction in score represents imrovement.|Mean Ocular QMG Changes from Baseline to Week 16 . 95% CI and p-values obtained from the analysis of covariance model to adjust for the baseline value of the outcome variable.|
1700021|NCT00995553|3124424|Superiority or Other|||||||0.73|||||||ANOVA||||
1700022|NCT00995553|3124425|Superiority or Other|||||||0.09|||||||ANOVA|||MATRICS Attention Index|
1700023|NCT00995553|3124425|Superiority or Other|||||||0.06|||||||ANOVA|||MATRICS Working Memory Index|
1700024|NCT00995501|3124426|Superiority||Odds Ratio (OR)|1.1||||0.87|2-Sided|99.6|0.42|2.7|||Regression, Logistic||||
1700025|NCT00995501|3124426|Superiority||Odds Ratio (OR)|1.1||||0.84|2-Sided|99.6|0.43|2.7|||Regression, Logistic|||Compare 4 arms with Dexamethasone vs. 4 arms with Placebo|
1700026|NCT00995501|3124426|Superiority||Odds Ratio (OR)|0.92||||0.8|2-Sided|99.6|0.37|2.3|||Regression, Logistic|||Compare 4 arms with intensive glucose control vs. 4 arms with conventional glucose control|
1700027|NCT00995501|3124427|Superiority||Odds Ratio (OR)|1.0||||0.9|2-Sided|99.6|0.49|2.2|||Regression, Logistic|||Compare 4 arms with light anesthesia vs. 4 arms with deep anesthesia|
1700028|NCT00995501|3124427|Superiority||Odds Ratio (OR)|0.96||||0.87|2-Sided|99.6|0.45|2.0|||Regression, Logistic|||Compare 4 arms with Dexamethasone vs. 4 arms with Placebo|
1700029|NCT00995501|3124427|Superiority||Odds Ratio (OR)|0.96||||0.86|2-Sided|99.6|0.45|2.0|||Regression, Logistic|||Compare 4 arms with intensive glucose control vs. 4 arms with conventional glucose control|
1700030|NCT00995436|3124435|Non-Inferiority or Equivalence|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.||||||0.08||||||Overall effect of treatment F(2,67) = 2.58.|ANCOVA|||Maxillary left molar.|
1700031|NCT00995436|3124435|Non-Inferiority or Equivalence|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.||||||0.05||||||Maxillary right molar. F(2, 67) = 3.10. Overall effect of treatment.|ANCOVA||||
1700032|NCT00995436|3124435|Non-Inferiority or Equivalence|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.09|||||2-Sided|95.0|-1.0|0.83|||||Maxillary left molar||
1700033|NCT00995436|3124435|Non-Inferiority or Equivalence|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|0.62|||||2-Sided|95.0|-0.32|1.55|||||Maxillary right molar||
1700034|NCT00995436|3124435|Non-Inferiority or Equivalence|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.96|||||2-Sided|95.0|-1.89|-0.04|||||Maxillary left molar||
1700035|NCT00995436|3124435|Non-Inferiority or Equivalence|The calculation indicated that for a study with the power of 80% and an alpha of 0.05 we required 21 participants per group. Assumed drop out rate 20%, suggesting 75 patients required.|Mean Difference (Final Values)|-0.58|||||2-Sided|95.0|-1.53|0.36|||||Maxillary right molar||
1700036|NCT00995371|3124438|Superiority or Other||Mean Difference (Final Values)|6.17|||>|0.05||95.0|-1.24|13.58|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.|
1700059|NCT00993928|3124546|Superiority or Other (legacy)|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Comparison of Q3: Percent change in sleep latency from baseline to week 7.|
1700037|NCT00995371|3124438|Superiority or Other||Mean Difference (Final Values)|16.13|||<|0.05||95.0|7.43|24.83|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.|
1700038|NCT00995371|3124439|Superiority or Other||Mean Difference (Final Values)|1.0|||>|0.05||95.0|-0.66|2.66|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.|
1700039|NCT00995371|3124439|Superiority or Other||Mean Difference (Final Values)|2.19|||<|0.05||95.0|0.61|3.77|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.|
1700040|NCT00995371|3124440|Superiority or Other||Mean Difference (Final Values)|5.65|||>|0.05||95.0|-4.12|15.41|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.|
1700041|NCT00995371|3124440|Superiority or Other||Mean Difference (Final Values)|11.33|||<|0.05|2-Sided|95.0|3.35|19.31|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.|
1700042|NCT00995371|3124441|Superiority or Other||Mean Difference (Final Values)|0.06|||>|0.05|2-Sided|95.0|-1.43|1.55|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.|
1700043|NCT00995371|3124441|Superiority or Other||Mean Difference (Final Values)|2.52|||<|0.05|2-Sided|95.0|1.09|3.96|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used.|
1700044|NCT00995215|3124446|Other|Statistical analysis was performed using a repeated measures analysis of variance and paired t-test.||||||0.05||||||A P value <0.05 was taken as indicative of statistical significance.|ANOVA|||The effects of electrical (spinal cord stimulation) SCS with disc electrode and wire leads on airway pressure generation were compared. Since SCS with the disc leads, when applied in clinical trials, resulted in airway pressure generation that approximated pressures generated with a normal maximum cough, airway pressure generation achieved during SCS with these leads served as our gold standard to which all comparisons were made.|
1700045|NCT00994461|3124510|Superiority or Other||||||<|0.0001||||||Cochran-Mantel-Haenszel (CMH) test stratified by H. pylori status was employed for the comparison of celecoxib and loxoprofen with placebo. The multiplicity of test was not adjusted because these comparisons were for the secondary objective.|Cochran-Mantel-Haenszel|CMH test stratified by H. pylori status was employed. Continuous correction was used.||Hypothesis testing was conducted with significant p-value level of under 0.05.|
1700046|NCT00994448|3124511|Superiority or Other||Mean Difference (Net)|16.3|Standard Error of the Mean|8.6||0.08|2-Sided|95.0|1.8|34.3|||t-test, 2 sided|||t test for mean of days retained in the bupropion versus placebo groups|
1700047|NCT00994318|3124515|Superiority or Other||Hazard Ratio (HR)|0.7||||0.12|2-Sided|95.0|0.45|1.1|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on subjects with a complete set of Hb values from central laboratory.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)"|
1700048|NCT00994318|3124515|Superiority or Other||Hazard Ratio (HR)|0.62||||0.008|2-Sided|95.0|0.43|0.88|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)."|
1700049|NCT00994318|3124515|Superiority or Other||Hazard Ratio (HR)|0.6||||0.02|2-Sided|95.0|0.39|0.93|||Log Rank|||"Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management without taking into account the Hb trigger.~FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)."|
1700050|NCT00994318|3124515|Superiority or Other||Hazard Ratio (HR)|0.68||||0.082|2-Sided|95.0|0.45|1.05|||Log Rank|||"FCM (Ferinject / Injectafer) targeting high ferritin level (400-600mcg/L) compared with FCM targeting low ferritin level (100 - 200 mcg/L).~Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:~FCM (high ferritin target) compared with oral iron.~FCM (high ferritin target) compared with FCM (low ferritin target).~FCM (low ferritin target) compared with oral iron."|
1700051|NCT00994318|3124515|Superiority or Other||Hazard Ratio (HR)|0.65||||0.026|2-Sided|95.0|0.44|0.95|||Log Rank|||"FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily).~Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:~FCM (high ferritin target) compared with oral iron.~FCM (high ferritin target) compared with FCM (low ferritin target).~FCM (low ferritin target) compared with oral iron."|
1700052|NCT00994279|3124516|Superiority or Other (legacy)|||||||0.98|||||||Mixed Models Analysis|||Null hypothesis is that the two groups would not differ in fatigue at 10 weeks.|
1700053|NCT00994279|3124517|Superiority or Other (legacy)|||||||0.53|||||||Chi-squared|||Null hypothesis is that the two arms will not differ in retention at 14 weeks.|
1700054|NCT00994123|3124528|Superiority or Other||Hazard Ratio (HR)|2.15||||0.059|2-Sided|95.0|0.97|4.76|||Log Rank||||
1700055|NCT00994123|3124528|Superiority or Other||Hazard Ratio (HR)|0.35||||0.008|2-Sided|95.0|0.16|0.76|||Log Rank||||
1700056|NCT00993928|3124542|Superiority or Other (legacy)|||||||0.64|||||||t-test, 2 sided|||Compare percent change from baseline to week 7 Distress Thermometer score.|
1700057|NCT00993928|3124544|Superiority or Other (legacy)|||||||0.42|||||||Chi-squared||||
1701531|NCT00968669|3128374|Superiority or Other|||||||0.319|||||||Pairwise Poisson Regression||||
1700060|NCT00993655|3124567|Superiority||Hazard Ratio (HR)|1.25||||0.4|2-Sided|95.0|0.74|2.13|||Log Rank|Adjusting for stratification factors at randomization|||
1700061|NCT00993655|3124568|Superiority||Hazard Ratio (HR)|1.22||||0.27|2-Sided|95.0|0.85|1.75|||Log Rank|Adjusting for stratification factors at randomization|||
1700062|NCT00993655|3124569|Superiority|||||||0.065|||||||Cochran-Mantel-Haenszel|adjusting for stratification factors at randomization||Assume that the 9-month PD rate in IV arm (Arm 1) will be 40% (based on experience with data from NCIC CTG OV.16 and that of NCRI UK). The target sample size of 200 will enable the detection of a 19% difference between Arms 1 and 3 in 9 month progression disease rate post randomization with 80% power at two-sided 0.05 level.|
1700063|NCT00993473|3124601|Non-Inferiority or Equivalence|Noninferiority would be demonstrated if the upper bound of the 95% confidence interval (CI) for the ratio of the rate of “all hypoglycemia” in the Lantus group to the rate in the NPH group was <1.15. Superiority would be demonstrated if the upper bound of the 95% CI was <1. The margin for noninferiority corresponded to one-half of the 30% difference in hypoglycemia event rate considered as a clinically significant difference by American Diabetes Association 2005 Working Group on Hypoglycemia.|Risk Ratio (RR)|1.18|Standard Error of the Mean|0.12|||2-Sided|95.0|0.97|1.44|||||Risk ratio between treatment groups (Lantus/NPH) estimated by Generalized Linear Model with fixed effect terms for randomization strata and treatment.|The sample size was calculated to ensure sufficient power so that the upper bound of the 2-sided 95% CI for the Lantus /NPH ratio would not exceed 1.15 based on an expected overall rate of „all hypoglycemia“ of 80 events per patient-year of exposure to NPH insulin and to Lantus. It was planned to randomize at least 45 and up to approximately 60 patients in each of the 2 treatment groups so that at least 70 patients would complete the 24 weeks of treatment.|
1700064|NCT00993421|3124634|Superiority or Other|||||||0.249|||||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.|
1700065|NCT00993421|3124634|Superiority or Other|||||||0.437|||||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.|
1700066|NCT00993421|3124634|Superiority or Other|||||||0.668|||||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.|
1700067|NCT00993421|3124634|Superiority or Other|||||||0.041|||||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.|
1700068|NCT00993421|3124634|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.|
1700069|NCT00993421|3124634|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.|
1700070|NCT00993421|3124634|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.|
1700071|NCT00993421|3124634|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Hypothesis: Treatment with a combination of LY377604 + sibutramine for 24 weeks would result in weight loss that was significantly greater than treatment with either sibutramine or LY377604 alone.|
1700072|NCT00993187|3124655|Superiority or Other||Difference in percent|41.01|||<|0.001|2-Sided|95.0|30.0|51.0|||ANCOVA||||
1700073|NCT00993187|3124656|Superiority or Other||Difference in Least Squares Mean|-1.72|||<|0.001|2-Sided|95.0|-2.2|-1.25|||ANCOVA||||
1700074|NCT00993187|3124657|Superiority or Other||Difference in percent|-14.7|||<|0.001|2-Sided|95.0|-23.0|-7.0|||ANCOVA||||
1700075|NCT00993187|3124658|Superiority or Other||Difference in Least Squares Mean|-23.5|||<|0.001|2-Sided|95.0|-30.0|-16.9|||ANCOVA||||
1700076|NCT00993187|3124661|Superiority or Other||Difference in Least Squares Mean|-0.8|||<|0.001|2-Sided|95.0|-1.0|-0.6|||ANCOVA||||
1700077|NCT00993031|3124680|Superiority or Other||Risk Ratio (RR)|1.34||||0.06|2-Sided|95.0|0.98|1.83|||Chi-squared||||
1700078|NCT00993031|3124681|Superiority or Other||Risk Ratio (RR)|1.22||||0.21|2-Sided|95.0|0.89|1.66|||Chi-squared||||
1700079|NCT00993031|3124683|Superiority or Other||Risk Ratio (RR)|0.75||||0.45|2-Sided|95.0|0.36|1.59|||Chi-squared||||
1700080|NCT00993031|3124684|Superiority or Other||Risk Ratio (RR)|0.85||||0.76|2-Sided|95.0|0.29|2.46|||Chi-squared||||
1700081|NCT00993031|3124685|Superiority or Other||Risk Ratio (RR)|0.83||||0.76|2-Sided|95.0|0.26|2.67|||Chi-squared||||
1700082|NCT00992992|3124702|Superiority or Other (legacy)||Percentage of participants|20.0|||||2-Sided|95.0|4.0|36.0|||||The estimated value reflects the percentage of participants with unconfirmed partial response.||
1700083|NCT00992992|3124702|Superiority or Other (legacy)||Percentage of participants|8.0|||||2-Sided|95.0|0.0|19.0|||||The estimated value reflects the percentage of participants with unconfirmed complete response unconfirmed (CRu).||
1700084|NCT00992992|3124702|Superiority or Other (legacy)||Percentage of participants|56.0|||||2-Sided|95.0|37.0|75.0|||||The estimated value reflects the percentage of participants with unconfirmed complete response (CR).||
1700085|NCT00992589|3124748|Superiority or Other||Least-Squares Mean Difference|0.024||||0.968|2-Sided|95.0|-1.167|1.214|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in Weekly Average I-GERQ-DD Total Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.|
1700248|NCT00990769|3125032|Superiority or Other||Mean Difference (Final Values)|1.9|Standard Deviation|5.0|>|0.05|2-Sided|95.0|||||t-test, 2 sided|||Sample size calculation concluded that 20 patients in each group would have 80% power to detect a mean difference of 4 ± 4 with alpha equal to 0.05, as would be determined by a two-sample T test.|
1700086|NCT00992589|3124749|Superiority or Other||Least-Squares Mean Difference|0.042||||0.96|2-Sided|95.0|-1.615|1.7|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in I-GERQ-R Total Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.|
1700087|NCT00992589|3124750|Superiority or Other||Least-Squares Mean Difference|-0.192||||0.498|2-Sided|95.0|-0.751|0.366|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Eating Behavior Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.|
1700088|NCT00992589|3124751|Superiority or Other||Least-Squares Mean Difference|-0.182||||0.479|2-Sided|95.0|-0.69|0.325|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Discomfort Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.|
1700089|NCT00992589|3124752|Superiority or Other||Least-Squares Mean Difference|0.006||||0.984|2-Sided|95.0|-0.619|0.632|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in weekly average I-GERQ-DD Regurgitation Subscale Score from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.|
1700090|NCT00992589|3124754|Superiority or Other||Least-Squares Mean Difference|0.03||||0.44|2-Sided|95.0|-0.047|0.108|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Double-blind (DB) Baseline as covariate to test the hypothesis of no difference in change in Weight-for-Age Z-Score from DB Baseline to DB Endpoint between Rabeprazole Sodium Total and Placebo.|
1700091|NCT00992589|3124755|Superiority or Other||Least-Squares Mean Difference|-0.449||||0.168|2-Sided|95.0|-1.087|0.19|||ANCOVA|||Analysis of Covariance with Treatment as fixed effect, Region and Age as stratification factors and Change from Open-label (OL) Baseline to OL Endpoint as covariate to test the hypothesis of no difference in change in daily average frequency of regurgitation from Double-blind (DB) Baseline to DB Endpoint between rabeprazole sodium total and placebo.|
1700092|NCT00992511|3124773|Non-Inferiority|Criterion for non-inferiority: upper limit (UL) of the two-sided 95% Confidence Interval (CI) for the ratio of GMT between the initial process-manufactured vaccine (GSK2340272A INI 2D Group) and (over) new process-manufactured vaccine (GSK2340272A NEW 2D Group) was less than or equal to (≤) 2.|Adjusted GMT ratio|1.17|||||2-Sided|95.0|0.86|1.61||||||To evaluate the immunological non-inferiority (in terms of vaccine-homologous virus H1N1 Haemagglutinin Inhibition [HI] antibody geometric mean titres [GMTs]) of the new process-manufactured A/California/7/2009 (H1N1)v-like antigen compared to the initial process-manufactured A/California/7/2009 (H1N1)v-like antigen, 21 days after first vaccination in healthy subjects aged 18 to 60 years.|
1700093|NCT00992511|3124773|Non-Inferiority|Criterion for non-inferiority: upper limit (UL) of the two-sided 95% Confidence Interval (CI) for the ratio of GMT between the initial process-manufactured vaccine (GSK2340272A INI 2D Group) and (over) new process-manufactured vaccine (GSK2340272A NEW 2D Group) was less than or equal to (≤) 2.|Adjusted GMT ratio|1.06|||||2-Sided|95.0|0.77|1.46||||||To evaluate the immunological non-inferiority (in terms of vaccine-homologous virus H1N1 Haemagglutinin Inhibition [HI] antibody geometric mean titres [GMTs]) of the new process-manufactured A/California/7/2009 (H1N1)v-like antigen compared to the initial process-manufactured A/California/7/2009 (H1N1)v-like antigen, 21 days after first vaccination in healthy subjects aged 18 to 60 years.|
1700094|NCT00992407|3124828|Non-Inferiority or Equivalence|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|0.58||||0.5294|2-Sided|95.0|-5.5|2.9|||t-test, 2 sided||||
1700095|NCT00992407|3124829|Non-Inferiority or Equivalence|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|-0.33||||0.9569|2-Sided|95.0|-12.8|12.2|||Student's t-test||||
1700096|NCT00992407|3124830|Non-Inferiority or Equivalence|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|10.0||||0.1768|2-Sided|95.0|-4.8|24.8|||Student's t-test|||Change from Baseline in Psychosocial Well-being Index (PWI) Score at Week 52|
1700097|NCT00992407|3124839|Non-Inferiority or Equivalence|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|1.29||||0.8118|2-Sided|95.0|-9.6|12.2|||t-test, 2 sided|||Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Week 52|
1700098|NCT00992407|3124840|Non-Inferiority or Equivalence|80% of power and 0.05 of significance level was used|Mean Difference (Final Values)|-0.61||||0.8595|2-Sided|95.0|-7.5|6.3|||t-test, 2 sided|||Change from Baseline in Personal and Social Performance (PSP) Scale Score at Week 52|
1700099|NCT00992264|3124860|Superiority or Other||Odds Ratio (OR)|0.67|||||2-Sided|95.0|0.44|1.03|||||OR for use of adjunct treatment at 12 months when persons assigned to Proactive Email reminders were compared to persons not assigned to receive Proactive Email reminders (ref group).|Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).|
1700100|NCT00992264|3124860|Superiority or Other||Odds Ratio (OR)|0.78|||||2-Sided|95.0|0.51|1.18|||||OR for use of adjunct treatment at 12 months when persons assigned to Dictated Navigation were compared to persons not assigned to Dictated Navigation (ref group).|Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).|
1700101|NCT00992264|3124860|Superiority or Other||Odds Ratio (OR)|0.7|||||2-Sided|95.0|0.46|1.07|||||OR for use of adjunct treatment at 12 months when persons assigned to receive a Testimonial were compared to persons assigned to receive No Testimonial (ref group).|Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).|
1700102|NCT00992264|3124860|Superiority or Other||Odds Ratio, log|0.94|||||2-Sided|95.0|0.62|1.43|||||OR for use of adjunct treatment at 12 months when persons assigned to Prescriptive Tone were compared to persons assigned to receive content in a Motivational Tone (ref group).|Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).|
1701532|NCT00968669|3128374|Superiority or Other|||||||0.271|||||||Pairwise Poisson Regression||||
1700103|NCT00992264|3124861|Superiority or Other||Odds Ratio (OR)|0.75|||||2-Sided|95.0|0.43|1.3|||||OR for smoking abstinence at 12 months when persons assigned to receive Proactive Email reminders were compared against persons who received No Emails (ref group).|Comparison of persons assigned to Proactive Email Outreach (n = 933) against persons assigned to receive No Proactive Email Outreach (n = 932).|
1700104|NCT00992264|3124861|Superiority or Other||Odds Ratio (OR)|1.19|||||2-Sided|95.0|0.7|2.02|||||OR for smoking abstinence at 12 months when persons assigned to Dictated navigation were compared to those not assigned to Dictated navigation (ref group).|Comparison of persons assigned to the Dictated Navigation arm (n = 934) against persons assigned to assigned free navigation of the website (n = 931).|
1700105|NCT00992264|3124861|Superiority or Other||Odds Ratio (OR)|1.12|||||2-Sided|95.0|0.66|1.91|||||OR for smoking abstinence at 12 months when persons who randomly received a Testimonial were compared against persons receiving No Testimonial (ref group).|Comparison of persons assigned to Testimonials (n = 933) against persons assigned to receive no testimonials (n = 932).|
1700106|NCT00992264|3124861|Superiority or Other||Odds Ratio (OR)|0.88|||||2-Sided|95.0|0.51|1.51|||||OR for smoking abstinence at 12 months in intent to treat sample. Participants receiving content written in a Prescriptive tone were compared against persons receiving content in a Motivational tone (ref group).|Comparison of persons assigned to Prescriptive message tone (n = 932) against persons assigned to Motivational message tone (n = 933).|
1700107|NCT00991939|3124912|Superiority or Other||Difference of proportions|0.0|Standard Error of the Mean|0.58||1|2-Sided|95.0|-0.975|0.708|||Fisher Exact||The estimated value is the proportion of success in the high dose pulse dexamethasone group minus the proportion of success in the standard prednisone group.|Four subjects were not included in this analysis because not enough data was available to assess the primary outcome at the time the study was terminated.|
1700108|NCT00991510|3124920|Non-Inferiority or Equivalence|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.985|||||2-Sided|90.0|0.877|1.106|||||||
1700109|NCT00991510|3124921|Non-Inferiority or Equivalence|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.873|||||2-Sided|90.0|0.787|0.968|||||||
1700110|NCT00991510|3124922|Non-Inferiority or Equivalence|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.959|||||2-Sided|90.0|0.899|1.023|||||||
1700111|NCT00991510|3124923|Non-Inferiority or Equivalence|Bioequivalence was accepted if the calculated 90 % CIs were within 0.80-1.25.|adjusted least-squares mean ratio|0.923|||||2-Sided|90.0|0.865|0.984||||||A total of 100 subjects were planned to be enrolled, allowing for 10% drop-out rate. Based on previous single dose studies, the intra-subject coefficients of variation were 14% and 50% for AUC and Cmax, respectively. Based on the literature similar intra subject coefficients of variation were observed in steady-state patients. With these expected CV(%) and an expected ratio of Cmax within 0.95 and 1.05, the study should have a power of at least 80 % to show bioequivalence with 80 subjects.|
1700112|NCT00991341|3124932|Superiority or Other||Risk Difference (RD)|-0.015||||0.53|2-Sided|95.0|-0.057|0.027|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.||
1700113|NCT00991341|3124933|Superiority or Other||Mean Difference (Net)|0.21||||0.71|2-Sided|95.0|-0.59|1.0|||Kruskal-Wallis||The longer storage duration arm is reference category.||
1700114|NCT00991341|3124934|Superiority or Other||Hazard Ratio (HR)|1.08||||0.22|2-Sided|95.0|0.96|1.22|||Regression, Cox|The treatment groups were compared with respect to days to first post-operative solid food, adjusting for baseline MODS.|The longer storage duration arm is reference category.||
1700115|NCT00991341|3124935|Superiority or Other||Hazard Ratio (HR)|1.11||||0.11|2-Sided|95.0|0.98|1.25||The treatment groups were compared with respect to days to first post-operative bowel movement, adjusting for baseline MODS.|Regression, Cox||The longer storage duration arm is reference category.||
1700116|NCT00991341|3124937|Superiority or Other||Mean Difference (Net)|-0.65|||<|0.01|2-Sided|95.0|-0.89|-0.41|||ANCOVA||The longer storage red blood cell units arm is the reference category. After adjusting for baseline bilirubin, the change in bilirubin values was 0.65 mg/dL lower in the shorter storage red blood cell units arm.||
1700117|NCT00991341|3124938|Superiority or Other|||||||0.1|||||||Kruskal-Wallis||||
1700118|NCT00991341|3124939|Superiority or Other||Mean Difference (Net)|1.93||||0.35|2-Sided|95.0|-2.11|5.98||The treatment arms were compared with respect to the change in troponin-I, adjusting for the baseline troponin-I value.|ANCOVA||The longer storage red blood cell units arm is the reference category. After adjusting for baseline troponin-I, the change in troponin-I values was 1.9 ng/mL higher in the shorter storage red blood cell units arm.|Troponin-I values recorded as 'too low to detect' were recoded as 0 since the median value of the minimum quantitative troponin-I value obtained among all participating sites was 0.01.|
1700119|NCT00991341|3124940|Superiority or Other||Mean Difference (Net)|-0.02||||0.62|2-Sided|95.0|-0.08|0.05|||ANCOVA|The treatment arms were compared with respect to the change in creatinine, adjusting for the baseline creatinine value.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline creatinine, the difference in the means was -0.02, positive values are in favor of longer storage duration.||
1700120|NCT00991341|3124941|Superiority or Other||Mean Difference (Net)|-0.12||||0.75|2-Sided|95.0|-0.62|0.37|||Kruskal-Wallis||||
1700121|NCT00991341|3124942|Superiority or Other||Risk Difference (RD)|-0.018||||0.41|2-Sided|95.0|-0.059|0.023|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.||
1700122|NCT00991341|3124943|Superiority or Other||Risk Difference (RD)|-0.027||||0.4|2-Sided|95.0|-0.09|0.035|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.||
1700123|NCT00991341|3124944|Superiority or Other||Risk Difference (RD)|0.018||||0.5|2-Sided|95.0|-0.033|0.069|||Fisher Exact||The difference in proportions between the two treatment arms was computed as the proportion of subjects with the event in the shorter storage duration arm minus the proportion of subjects with the event in the longer storage duration arm.||
1700124|NCT00991341|3124945|Superiority or Other||Mean Difference (Net)|-0.32||||0.2|2-Sided|95.0|-0.82|0.17|||ANCOVA|The treatment groups were compared with respect to 28-day change in MODS, adjusting for baseline MODS.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.32; positive values are in favor of longer storage duration.||
1700125|NCT00991341|3124946|Superiority or Other||Hazard Ratio (HR)|0.83||||0.5|2-Sided|95.0|0.48|1.43|||Regression, Cox|The treatment groups were compared with respect to all-cause mortality, adjusting for baseline MODS.|The longer storage duration arm is the reference category.||
1700126|NCT00991341|3124947|Superiority or Other||Mean Difference (Net)|-0.17||||0.44|2-Sided|95.0|-0.6|0.26|||ANCOVA|The treatment groups were compared with respect to the change in MODS, adjusting for baseline MODS.|The longer storage red blood cell units arm is the reference category. After adjusting for baseline MODS, the difference in the means was -0.17, positive values are in favor of longer storage duration.||
1700127|NCT00991302|3124953|Superiority or Other|||||||0.52|||||||Wilcoxon (Mann-Whitney)|stratified by dosing complexity||"Treatment comparison was made using a Wilcoxon rank sum test stratified by dosing complexity.~The test was not stratified by region of enrollment due to dosing complexity and region of enrollment were almost identical: almost all (exception with two) participants in the US region were on QD and all participants in the Peru region were on BID or TID."|
1700128|NCT00991276|3124965|Superiority or Other||LS Mean Difference|2.01|Standard Error of the Mean|1.64||0.2222|2-Sided|95.0|-1.24|5.26||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700129|NCT00991276|3124965|Superiority or Other||LS Mean Difference|3.25|Standard Error of the Mean|1.65||0.0506|2-Sided|95.0|-0.01|6.51||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700130|NCT00991276|3124965|Superiority or Other||LS Mean Difference|5.27|Standard Error of the Mean|1.66||0.0019|2-Sided|95.0|1.98|8.55||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700131|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-1.98|Standard Error of the Mean|2.25||0.3792|2-Sided|95.0|-6.43|2.47||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700132|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|2.26||0.7565|2-Sided|95.0|-5.18|3.77||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700133|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-2.69|Standard Error of the Mean|2.28||0.2405|2-Sided|95.0|-7.2|1.82||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Snoring: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700134|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-8.45|Standard Error of the Mean|3.19||0.009|2-Sided|95.0|-14.76|-2.15||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700135|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-6.11|Standard Error of the Mean|3.2||0.0584|2-Sided|95.0|-12.43|0.22||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700136|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-14.56|Standard Error of the Mean|3.22|<|0.0001|2-Sided|95.0|-20.93|-8.19||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Disturbance: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700137|NCT00991276|3124966|Superiority or Other||LS Mean Difference|0.06|Standard Error of the Mean|0.06|<|0.3396|2-Sided|95.0|-0.06|0.18||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700138|NCT00991276|3124966|Superiority or Other||LS Mean Difference|0.08|Standard Error of the Mean|0.06|<|0.2||95.0|-0.04|0.2||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700139|NCT00991276|3124966|Superiority or Other||LS Mean Difference|0.14|Standard Error of the Mean|0.06|<|0.0278|2-Sided|95.0|0.02|0.27||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Optimal Sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700140|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-5.01|Standard Error of the Mean|2.41|<|0.0395|2-Sided|95.0|-9.78|-0.24||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700141|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-5.13|Standard Error of the Mean|2.42|<|0.0359|2-Sided|95.0|-9.91|-0.34||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700142|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-10.14|Standard Error of the Mean|2.44|<|0.0001|2-Sided|95.0|-14.96|-5.32||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||9-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700143|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-3.35|Standard Error of the Mean|2.45|<|0.1746|2-Sided|95.0|-8.21|1.51||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700144|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-6.54|Standard Error of the Mean|2.46|<|0.0089|2-Sided|95.0|-11.42|-1.67||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700145|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-9.89|Standard Error of the Mean|2.48|<|0.0001|2-Sided|95.0|-14.8|-4.99||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||6-Item Sleep Problems Index: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700146|NCT00991276|3124966|Superiority or Other||LS Mean Difference|0.53|Standard Error of the Mean|0.31|<|0.0918|2-Sided|95.0|-0.09|1.15||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700147|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-0.07|Standard Error of the Mean|0.31|<|0.8184|2-Sided|95.0|-0.69|0.55||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700249|NCT00990704|3125040|Superiority or Other||Difference between arms in percentage|13.6||||0.518|2-Sided|95.0|-22.36|49.63|||Fisher Exact||||
1701673|NCT00966875|3128635|Superiority or Other|||||||0.017||||||P-value is for ACR50-NRI at Week 12.|Fisher Exact||||
1700148|NCT00991276|3124966|Superiority or Other||LS Mean Difference|0.46|Standard Error of the Mean|0.32|<|0.1496|2-Sided|95.0|-0.17|1.09||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Sleep Quantity: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700149|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-2.38|Standard Error of the Mean|2.05|<|0.2468|2-Sided|95.0|-6.44|1.67||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700150|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-0.05|Standard Error of the Mean|2.05|<|0.981|2-Sided|95.0|-4.12|4.02||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700151|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-2.43|Standard Error of the Mean|2.07|<|0.242|2-Sided|95.0|-6.53|1.66||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Somnolence: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700152|NCT00991276|3124966|Superiority or Other||LS Mean Difference|3.1|Standard Error of the Mean|3.95|<|0.4342|2-Sided|95.0|-4.72|10.93||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700153|NCT00991276|3124966|Superiority or Other||LS Mean Difference|11.07|Standard Error of the Mean|3.97|<|0.0061|2-Sided|95.0|3.22|18.92||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700154|NCT00991276|3124966|Superiority or Other||LS Mean Difference|14.17|Standard Error of the Mean|4.0|<|0.0006|2-Sided|95.0|6.25|22.08||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Adequacy: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700155|NCT00991276|3124966|Superiority or Other||LS Mean Difference|2.23|Standard Error of the Mean|1.78|<|0.2144|2-Sided|95.0|-1.3|5.76||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700156|NCT00991276|3124966|Superiority or Other||LS Mean Difference|-1.52|Standard Error of the Mean|1.79|<|0.398|2-Sided|95.0|-5.06|2.02||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700157|NCT00991276|3124966|Superiority or Other||LS Mean Difference|0.71|Standard Error of the Mean|1.8|<|0.6947|2-Sided|95.0|-2.85|4.27||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Awaken Short of Breath/with Headache: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700158|NCT00991276|3124967|Superiority or Other||LS Mean Difference|-9.48|Standard Error of the Mean|3.2||0.0036|2-Sided|95.0|-15.81|-3.16||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700250|NCT00990561|3125052|Superiority or Other||Mean Difference (Net)|3.0|||<|0.001|2-Sided|95.0|||||t-test, 2 sided|||Null hypothesis = there is no difference between using ultravate once daily vs. twice daily|
1702849|NCT00946998|3131637|Superiority||||||>|0.99||||||For death|Chi-squared||||
1700159|NCT00991276|3124967|Superiority or Other||LS Mean Difference|1.9|Standard Error of the Mean|3.23||0.5569|2-Sided|95.0|-4.49|8.29||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700160|NCT00991276|3124967|Superiority or Other||LS Mean Difference|-7.58|Standard Error of the Mean|3.26||0.0215|2-Sided|95.0|-14.03|-1.14||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700161|NCT00991276|3124968|Superiority or Other||LS Mean Difference|-0.02|Standard Error of the Mean|0.2||0.9403|2-Sided|95.0|-0.42|0.39||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700162|NCT00991276|3124968|Superiority or Other||LS Mean Difference|1.05|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|0.65|1.46||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700163|NCT00991276|3124968|Superiority or Other||LS Mean Difference|1.04|Standard Error of the Mean|0.21|<|0.0001|2-Sided|95.0|0.63|1.45||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700164|NCT00991276|3124969|Superiority or Other||LS Mean Difference|3.14|Standard Error of the Mean|5.19||0.5461|2-Sided|95.0|-7.13|13.4||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700165|NCT00991276|3124969|Superiority or Other||LS Mean Difference|-28.45|Standard Error of the Mean|5.27|<|0.0001|2-Sided|95.0|-38.89|-18.02||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700166|NCT00991276|3124969|Superiority or Other||LS Mean Difference|-25.32|Standard Error of the Mean|5.31|<|0.0001|2-Sided|95.0|-35.83|-14.8||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700167|NCT00991276|3124970|Superiority or Other||LS Mean Difference|0.13|Standard Error of the Mean|0.18||0.4677|2-Sided|95.0|-0.22|0.48||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700168|NCT00991276|3124970|Superiority or Other||LS Mean Difference|-0.96|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.31|-0.6||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700169|NCT00991276|3124970|Superiority or Other||LS Mean Difference|-0.83|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.18|-0.47||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700251|NCT00989950|3125101|Superiority or Other||Mean Difference (Final Values)|0.34|Standard Deviation|14.0||0.588|2-Sided|95.0|0.0|233.0|||ANOVA||||
1700252|NCT00989911|3125114|Superiority or Other|||||||0.03|||||||t-test, 2 sided||||
1700253|NCT00989768|3125128|Superiority or Other|||||||0.36|||||||t-test, 2 sided||||
1700170|NCT00991276|3124977|Superiority or Other||LS Mean Difference|1.56|Standard Error of the Mean|1.11||0.1622|2-Sided|95.0|-0.64|3.75||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700171|NCT00991276|3124977|Superiority or Other||LS Mean Difference|5.24|Standard Error of the Mean|1.12|<|0.0001|2-Sided|95.0|3.02|7.45||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700172|NCT00991276|3124977|Superiority or Other||LS Mean Difference|6.8|Standard Error of the Mean|1.12|<|0.0001|2-Sided|95.0|4.57|9.02||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700173|NCT00991276|3124978|Superiority or Other||LS Mean Difference|6.86|Standard Error of the Mean|5.33||0.2005|2-Sided|95.0|-3.69|17.42||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700174|NCT00991276|3124978|Superiority or Other||LS Mean Difference|25.86|Standard Error of the Mean|5.37|<|0.0001|2-Sided|95.0|15.22|36.49||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700175|NCT00991276|3124978|Superiority or Other||LS Mean Difference|32.72|Standard Error of the Mean|5.41|<|0.0001|2-Sided|95.0|22.02|43.42||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700176|NCT00991276|3124979|Superiority or Other||LS Mean Difference|-1.02|Standard Error of the Mean|1.84||0.5815|2-Sided|95.0|-4.66|2.63||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700177|NCT00991276|3124979|Superiority or Other||LS Mean Difference|-2.28|Standard Error of the Mean|1.86||0.2209|2-Sided|95.0|-5.95|1.39||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700178|NCT00991276|3124979|Superiority or Other||LS Mean Difference|-3.3|Standard Error of the Mean|1.87||0.08|2-Sided|95.0|-7.0|0.4||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700179|NCT00991276|3124980|Superiority or Other||LS Mean Difference|0.76|Standard Error of the Mean|4.38||0.8622|2-Sided|95.0|-7.9|9.43||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700180|NCT00991276|3124980|Superiority or Other||LS Mean Difference|-24.74|Standard Error of the Mean|4.41|<|0.0001|2-Sided|95.0|-33.46|-16.02||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700254|NCT00989768|3125129|Superiority or Other|||||||0.61|||||||t-test, 2 sided||||
1700255|NCT00989768|3125130|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1700256|NCT00989768|3125131|Superiority or Other||Mean Difference (Net)|0.16|Standard Deviation|0.36|<|0.0001||95.0|||||t-test, 2 sided|||In this study the null hypothesis was that BoNT-A1 had the same effect (halus)than the BoNT-A2.|
1700181|NCT00991276|3124980|Superiority or Other||LS Mean Difference|-23.98|Standard Error of the Mean|4.45|<|0.0001|2-Sided|95.0|-32.78|-15.18||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700182|NCT00991276|3124981|Superiority or Other||LS Mean Difference|-7.33|Standard Error of the Mean|4.65||0.1175|2-Sided|95.0|-16.54|1.87||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700183|NCT00991276|3124981|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|4.68||0.9325|2-Sided|95.0|-9.67|8.87||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700184|NCT00991276|3124981|Superiority or Other||LS Mean Difference|-7.73|Standard Error of the Mean|4.72||0.104|2-Sided|95.0|-17.07|1.61||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700185|NCT00991276|3124982|Superiority or Other||LS Mean Difference|46.47|Standard Error of the Mean|7.59|<|0.0001|2-Sided|95.0|31.45|61.48||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700186|NCT00991276|3124982|Superiority or Other||LS Mean Difference|-35.77|Standard Error of the Mean|7.63|<|0.0001|2-Sided|95.0|-50.88|-20.66||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700187|NCT00991276|3124982|Superiority or Other||LS Mean Difference|10.69|Standard Error of the Mean|7.71|<|0.1677|2-Sided|95.0|-4.56|25.95||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700188|NCT00991276|3124984|Superiority or Other||LS Mean Difference|-3.03|Standard Error of the Mean|1.01||0.0032|2-Sided|95.0|-5.02|-1.04||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700189|NCT00991276|3124984|Superiority or Other||LS Mean Difference|-3.07|Standard Error of the Mean|1.01||0.0029|2-Sided|95.0|-5.07|-1.07||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700190|NCT00991276|3124984|Superiority or Other||LS Mean Difference|-6.1|Standard Error of the Mean|1.01|<|0.0001|2-Sided|95.0|-8.1|-4.09||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700191|NCT00991276|3124985|Superiority or Other||LS Mean Difference|0.74|Standard Error of the Mean|0.24||0.0026|2-Sided|95.0|0.26|1.21||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700257|NCT00989664|3125153|Superiority or Other||||||<|0.001|||||||McNemar||||
1700258|NCT00989235|3125238|Superiority or Other||estimate of difference|-10.6|||||2-Sided|95.0|-31.1|10.0|||||||
1700259|NCT00989235|3125239|Superiority or Other||estimate of difference|-7.7|||||2-Sided|95.0|-22.6|7.3|||||||
1700192|NCT00991276|3124985|Superiority or Other||LS Mean Difference|-1.42|Standard Error of the Mean|0.24|<|0.0001|2-Sided|95.0|-1.9|-0.95||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700193|NCT00991276|3124985|Superiority or Other||LS Mean Difference|-0.69|Standard Error of the Mean|0.24|<|0.0056|2-Sided|95.0|-1.17|-0.21||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700194|NCT00991276|3124986|Superiority or Other||LS Mean Difference|3.9|Standard Error of the Mean|1.28||0.0028|2-Sided|95.0|1.37|6.44||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700195|NCT00991276|3124986|Superiority or Other||LS Mean Difference|-6.35|Standard Error of the Mean|1.29|<|0.0001|2-Sided|95.0|-8.91|-3.8||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700196|NCT00991276|3124986|Superiority or Other||LS Mean Difference|-2.45|Standard Error of the Mean|1.3|<|0.0617|2-Sided|95.0|-5.02|0.12||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700197|NCT00991276|3124987|Superiority or Other||LS Mean Difference|1.84|Standard Error of the Mean|0.53||0.0007|2-Sided|95.0|0.79|2.89||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700198|NCT00991276|3124987|Superiority or Other||LS Mean Difference|-4.71|Standard Error of the Mean|0.53|<|0.0001|2-Sided|95.0|-5.76|-3.65||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700199|NCT00991276|3124987|Superiority or Other||LS Mean Difference|-2.86|Standard Error of the Mean|0.54|<|0.0001|2-Sided|95.0|-3.93|-1.8||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700200|NCT00991276|3124988|Superiority or Other||LS Mean Difference|-28.95|Standard Error of the Mean|3.14|<|0.0001|2-Sided|95.0|-35.16|-22.74||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700201|NCT00991276|3124988|Superiority or Other||LS Mean Difference|14.42|Standard Error of the Mean|3.15|<|0.0001|2-Sided|95.0|8.18|20.67||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700202|NCT00991276|3124988|Superiority or Other||LS Mean Difference|-14.53|Standard Error of the Mean|3.19|<|0.0001|2-Sided|95.0|-20.84|-8.22||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700260|NCT00989235|3125240|Superiority or Other||estimate of difference|-1.1|||||2-Sided|95.0|-12.9|10.7|||||||
1700261|NCT00989235|3125241|Superiority or Other||Hazard Ratio (HR)|0.87|||||2-Sided|95.0|0.45|1.69|||||Hazard ratio determined by a Cox proportional hazards model with treatment as the only covariate.|Through Month 12|
1702850|NCT00946998|3131638|Superiority|||||||0.61|||||||Mixed Models Analysis||||
1700203|NCT00991276|3124989|Superiority or Other||LS Mean Difference|-25.84|Standard Error of the Mean|2.86|<|0.0001|2-Sided|95.0|-31.51|-20.17||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700204|NCT00991276|3124989|Superiority or Other||LS Mean Difference|11.35|Standard Error of the Mean|2.88|<|0.0001|2-Sided|95.0|5.65|17.04||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700205|NCT00991276|3124989|Superiority or Other||LS Mean Difference|-14.5|Standard Error of the Mean|2.91|<|0.0001|2-Sided|95.0|-20.26|-8.74||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700206|NCT00991276|3124990|Superiority or Other||LS Mean Difference|-0.45|Standard Error of the Mean|2.52||0.8589|2-Sided|95.0|-5.44|4.54||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700207|NCT00991276|3124990|Superiority or Other||LS Mean Difference|-4.9|Standard Error of the Mean|2.55||0.0568|2-Sided|95.0|-9.95|0.14||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700208|NCT00991276|3124990|Superiority or Other||LS Mean Difference|-5.35|Standard Error of the Mean|2.57||0.0396|2-Sided|95.0|-10.44|-0.26||This analysis was step 6 in a step-down procedure (if p-value < 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700209|NCT00991276|3124991|Superiority or Other||LS Mean Difference|5.2|Standard Error of the Mean|0.97|<|0.0001|2-Sided|95.0|3.27|7.12||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700210|NCT00991276|3124991|Superiority or Other||LS Mean Difference|-7.87|Standard Error of the Mean|0.98|<|0.0001|2-Sided|95.0|-9.81|-5.93||This analysis was step 5 in a step-down procedure (if p-value < 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700211|NCT00991276|3124991|Superiority or Other||LS Mean Difference|-2.67|Standard Error of the Mean|0.99|<|0.0077|2-Sided|95.0|-4.63|-0.72||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700212|NCT00991276|3124992|Superiority or Other||LS Mean Difference|-23.56|Standard Error of the Mean|2.81|<|0.0001|2-Sided|95.0|-29.12|-18.01||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700213|NCT00991276|3124992|Superiority or Other||LS Mean Difference|18.59|Standard Error of the Mean|2.83|<|0.0001|2-Sided|95.0|12.99|24.19||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700262|NCT00989235|3125243|Superiority or Other||estimate of difference|-8.6|||||2-Sided|95.0|-20.3|3.2|||||||
1700263|NCT00989235|3125244|Superiority or Other||estimate of difference|0.4|||||2-Sided|95.0|-17.2|18.0|||||||
1700264|NCT00989235|3125245|Superiority or Other||Adjusted Difference|0.23|||||2-Sided|95.0|-0.09|0.55|||||Change from Baseline = Post-baseline - Baseline value.|Day 365|
1700214|NCT00991276|3124992|Superiority or Other||LS Mean Difference|-4.97|Standard Error of the Mean|2.85|<|0.0834|2-Sided|95.0|-10.61|0.67||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage R sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700215|NCT00991276|3124992|Superiority or Other||LS Mean Difference|-11.17|Standard Error of the Mean|4.14|<|0.008|2-Sided|95.0|-19.37|-2.97||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700216|NCT00991276|3124992|Superiority or Other||LS Mean Difference|32.1|Standard Error of the Mean|4.18|<|0.0001|2-Sided|95.0|23.83|40.36||This analysis was step 4 in a step-down procedure (if p-value < 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700217|NCT00991276|3124992|Superiority or Other||LS Mean Difference|20.93|Standard Error of the Mean|4.2|<|0.0001|2-Sided|95.0|12.61|29.25||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N3 sleep/SWS: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700218|NCT00991276|3124992|Superiority or Other||LS Mean Difference|37.17|Standard Error of the Mean|5.96|<|0.0001|2-Sided|95.0|25.38|48.96||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700219|NCT00991276|3124992|Superiority or Other||LS Mean Difference|-14.47|Standard Error of the Mean|6.0|<|0.0174|2-Sided|95.0|-26.35|-2.59||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700220|NCT00991276|3124992|Superiority or Other||LS Mean Difference|22.7|Standard Error of the Mean|6.05|<|0.0003|2-Sided|95.0|10.74|34.67||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N2 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700221|NCT00991276|3124992|Superiority or Other||LS Mean difference|4.65|Standard Error of the Mean|2.06|<|0.0257|2-Sided|95.0|0.58|8.73||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700222|NCT00991276|3124992|Superiority or Other||LS Mean Difference|-10.32|Standard Error of the Mean|2.08|<|0.0001|2-Sided|95.0|-14.43|-6.21||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700223|NCT00991276|3124992|Superiority or Other||LS Mean Difference|-5.67|Standard Error of the Mean|2.09|<|0.0076|2-Sided|95.0|-9.8|-1.54||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||Stage N1 sleep: P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700224|NCT00991276|3124993|Superiority or Other||LS Mean Difference|4.03|Standard Error of the Mean|7.27||0.5807|2-Sided|95.0|-10.36|18.41||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700265|NCT00989235|3125245|Superiority or Other||Adjusted Difference|-0.03|||||2-Sided|95.0|-0.37|0.31|||||Change from Baseline = Post-baseline - Baseline value.|Day 337|
1701674|NCT00966875|3128635|Superiority or Other|||||||0.013||||||P-value is for ACR50-NRI at Week 12.|Fisher Exact||||
1700225|NCT00991276|3124993|Superiority or Other||LS Mean Difference|26.79|Standard Error of the Mean|7.34||0.0004|2-Sided|95.0|12.26|41.32||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700226|NCT00991276|3124993|Superiority or Other||LS Mean Difference|30.81|Standard Error of the Mean|7.42|<|0.0001|2-Sided|95.0|16.14|45.49||This analysis was step 3 in a step-down procedure (if p-value < 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700227|NCT00991276|3124994|Superiority or Other||LS Mean Difference|-4.94|Standard Error of the Mean|0.88|<|0.0001|2-Sided|95.0|-6.68|-3.21||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700228|NCT00991276|3124994|Superiority or Other||LS Mean Difference|1.26|Standard Error of the Mean|0.88|<|0.1541|2-Sided|95.0|-0.48|3.01||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700229|NCT00991276|3124994|Superiority or Other||LS Mean Difference|-3.68|Standard Error of the Mean|0.89|<|0.0001|2-Sided|95.0|-5.44|-1.92||This analysis was step 2 in a step-down procedure (if p-value < 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700230|NCT00991276|3124995|Superiority or Other||LS Mean Difference|-0.17|Standard Error of the Mean|4.32||0.9684|2-Sided|95.0|-8.72|8.38||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700231|NCT00991276|3124995|Superiority or Other||LS Mean Difference|-26.93|Standard Error of the Mean|4.35|<|0.0001|2-Sided|95.0|-35.54|-18.32||This analysis was not included in the step-down procedure (if p-value < 0.05, then continue to next step) to control Type I error.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The LS means and SE were used to test for a treatment difference and construct 2-sided 95% CIs. The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700232|NCT00991276|3124995|Superiority or Other||LS Mean Difference|-27.1|Standard Error of the Mean|4.38|<|0.0001|2-Sided|95.0|-35.78|-18.42||This analysis was step 1 in a step-down procedure (if p-value < 0.05, then continue to next step) used to control the Type I error rate.|Mixed Models Analysis|||P-value was calculated using linear mixed model analysis with treatment, period and sequence as fixed effects. Random effects were participant within sequence and residual error. The least squares (LS) means and standard errors (SE) were used to test for a treatment difference and construct 2-sided 95% confidence intervals (CIs). The hypothesis test was 2-sided and conducted at the 5% level of significance.|
1700233|NCT00991029|3125011|Superiority||Hazard Ratio (HR)|1.51||||0.27|2-Sided|95.0|0.73|3.13|||Log Rank||||
1700234|NCT00991029|3125012|Superiority||Hazard Ratio (HR)|3.12|||<|0.001|2-Sided|95.0|1.67|5.83|||Log Rank||||
1700235|NCT00991029|3125013|Superiority||Hazard Ratio (HR)|2.45||||0.04|2-Sided|95.0|1.01|5.9|||Log Rank||||
1700236|NCT00991029|3125014|Superiority|||||||0.16|||||||Log Rank||||
1700237|NCT00991029|3125015|Superiority||Hazard Ratio (HR)|1.01||||0.99|2-Sided|95.0|0.14|7.14|||Log Rank||||
1700238|NCT00991029|3125016|Superiority||Hazard Ratio (HR)|1.68||||0.47|2-Sided|95.0|0.4|7.03|||Log Rank||||
1700239|NCT00991029|3125017|Superiority||Hazard Ratio (HR)|0.84||||0.13|2-Sided|95.0|0.67|1.05|||Log Rank||||
1700240|NCT00991029|3125018|Superiority||Hazard Ratio (HR)|0.74||||0.01|2-Sided|95.0|0.58|0.94|||Log Rank||||
1700241|NCT00991029|3125019|Superiority||Hazard Ratio (HR)|1.51||||0.52|2-Sided|95.0|0.43|5.35|||Log Rank||||
1700242|NCT00991029|3125020|Superiority||Hazard Ratio (HR)|1.44||||0.46|2-Sided|95.0|0.55|3.78|||Log Rank||||
1700243|NCT00991029|3125021|Superiority||Hazard Ratio (HR)|0.72||||0.01|2-Sided|95.0|0.56|0.92|||Log Rank||||
1700244|NCT00991029|3125022|Superiority||Hazard Ratio (HR)|2.32||||0.02|2-Sided|95.0|1.1|4.87|||Log Rank||||
1700245|NCT00991029|3125023|Superiority||Hazard Ratio (HR)|0.75||||0.02|2-Sided|95.0|0.59|0.95|||Log Rank||||
1700246|NCT00990964|3125024|Superiority or Other||One sample proportion|0.974|||||2-Sided|95.0|0.965|0.98|||||||
1700247|NCT00990964|3125025|Superiority or Other||One sample proportion|0.94|||||2-Sided|95.0|0.929|0.951|||||||
1700266|NCT00989235|3125245|Superiority or Other||Adjusted Difference|-0.03|||||2-Sided|95.0|-0.27|0.22|||||Change from Baseline = Post-baseline - Baseline value.|Day 309|
1701675|NCT00966875|3128635|Superiority or Other|||||||0.019||||||P-value is for ACR50-NRI at Week 12.|Fisher Exact||||
1700267|NCT00989235|3125245|Superiority or Other||Adjusted Difference|0.13|||||2-Sided|95.0|-0.12|0.38|||||Change from Baseline = Post-baseline - Baseline value.|Day 281|
1700268|NCT00989235|3125245|Superiority or Other||Adjusted Difference|0.08|||||2-Sided|95.0|-0.19|0.36|||||Change from Baseline = Post-baseline - Baseline value.|Day 253|
1700269|NCT00989235|3125245|Superiority or Other||Adjusted Difference|-0.04|||||2-Sided|95.0|-0.32|0.25|||||Change from Baseline = Post-baseline - Baseline value.|Day 225|
1700270|NCT00989235|3125245|Superiority or Other||Adjusted Difference|-0.12|||||2-Sided|95.0|-0.38|0.13|||||Change from Baseline = Post-baseline - Baseline value.|Day 197|
1700271|NCT00989235|3125245|Superiority or Other||Adjusted Difference|-0.13|||||2-Sided|95.0|-0.41|0.15|||||Change from Baseline = Post-baseline - Baseline value.|Day 169|
1700272|NCT00989235|3125245|Superiority or Other||Adjusted Difference|0.03|||||2-Sided|95.0|-0.26|0.32|||||Change from Baseline = Post-baseline - Baseline value.|Day 141|
1700273|NCT00989235|3125245|Superiority or Other||Adjusted Difference|-0.23|||||2-Sided|95.0|-0.5|0.04|||||Change from Baseline = Post-baseline - Baseline value.|Day 113|
1700274|NCT00989235|3125245|Superiority or Other||Adjusted Difference|-0.08|||||2-Sided|95.0|-0.37|0.2|||||Change from Baseline = Post-baseline - Baseline value.|Day 85|
1700275|NCT00989235|3125245|Superiority or Other||Adjusted Difference|-0.09|||||2-Sided|95.0|-0.34|0.17|||||Change from Baseline = Post-baseline - Baseline value.|Day 57|
1700276|NCT00989235|3125245|Superiority or Other||Adjusted difference|0.18|||||2-Sided|95.0|-0.11|0.46|||||Change from Baseline = Post-baseline - Baseline value.|Day 29|
1700277|NCT00989196|3125256|Non-Inferiority or Equivalence (legacy)|For the comparison of the PK profile of Human-cl rhFVIII with Kogenate, the 90% confidence intervals for the ratio or log-ratio of Human-cl rhFVIII over Kogenate for selected, dose independent or dose adjusted, PK parameters will be presented. In addition a formal statistical procedure will test whether the ratio of mean AUCs is within a 80 to 125% range to show bioequivalence.|Ratio|0.98|||||2-Sided|90.0|0.874|1.107|||||||
1700278|NCT00988884|3125279|Superiority or Other||Difference in percentage|-0.4||||0.806|2-Sided|95.0|-3.5|2.7|||Miettinen and Nurminen||||
1700279|NCT00988884|3125282|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is >0.67|Fold difference in GMT|0.96|||<|0.001|2-Sided|97.5|0.76|1.21|||ANOVA|||Anti-FIM 2/3|
1700280|NCT00988884|3125282|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is >0.67|Fold difference in GMT|0.95|||<|0.001|2-Sided|97.5|0.84|1.08|||ANOVA|||Anti-PRN|
1700281|NCT00988884|3125282|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is >0.67|Fold difference in GMT|0.91|||<|0.001|2-Sided|97.5|0.83|1.01|||ANOVA|||Anti-FHA|
1700282|NCT00988884|3125282|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the fold difference is >0.67|Fold difference in GMT|0.8|||<|0.003|2-Sided|97.5|0.69|0.92|||ANOVA|||Anti-PT|
1700283|NCT00988884|3125283|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-0.2|||<|0.001|2-Sided|97.5|-1.2|0.7|||Miettinen and Nurminen|||Anti-tetanus titer >=0.1 IU/mL|
1700284|NCT00988884|3125283|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|0.0|||<|0.001|2-Sided|97.5|-0.8|0.9|||Miettinen and Nurminen|||Anti-diphtheria titer >=0.1 IU/mL|
1700285|NCT00988884|3125284|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-2.1|||<|0.001|2-Sided|97.5|-4.7|0.3|||Miettinen and Nurminen|||Serogroup W-135|
1700286|NCT00988884|3125284|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|2.1|||<|0.001|2-Sided|97.5|-1.8|6.1|||Miettinen and Nurminen|||Serogroup Y|
1700287|NCT00988884|3125284|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|-2.1|||<|0.001|2-Sided|97.5|-5.4|1.1|||Miettinen and Nurminen|||Serogroup C|
1700288|NCT00988884|3125284|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 97.5% confidence interval for the percentage difference is greater than -10|Difference in percentage|3.8|||<|0.001|2-Sided|97.5|-1.7|9.3|||Miettinen and Nurminen|||Serogroup A|
1700289|NCT00988884|3125285|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.99|||<|0.001|2-Sided|95.0|0.88|1.1|||ANOVA|||Anti-HPV 58|
1700290|NCT00988884|3125285|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.98|||<|0.001|2-Sided|95.0|0.88|1.1|||ANOVA|||Anti-HPV 52|
1700291|NCT00988884|3125285|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|1.1|||<|0.001|2-Sided|95.0|0.97|1.25|||ANOVA|||Anti-HPV 45|
1700292|NCT00988884|3125285|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.99|||<|0.001|2-Sided|95.0|0.89|1.11|||ANOVA|||Anti-HPV 33|
1700380|NCT00986362|3125596|Superiority or Other||Odds Ratio (OR)|0.613||||0.679|2-Sided|95.0|0.07|4.509|||Fisher Exact||||
1700381|NCT00986245|3125628|Superiority or Other||Mean Difference (Net)|0.8|||<|0.05|||||||Sign test||||
1700293|NCT00988884|3125285|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|1.04|||<|0.001|2-Sided|95.0|0.93|1.17|||ANOVA|||Anti-HPV 31|
1700294|NCT00988884|3125285|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.99|||<|0.001|2-Sided|95.0|0.88|1.12|||ANOVA|||Anti-HPV 18|
1700295|NCT00988884|3125285|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.98|||<|0.001|2-Sided|95.0|0.89|1.09|||ANOVA|||Anti-HPV 16|
1700296|NCT00988884|3125285|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.97|||<|0.001|2-Sided|95.0|0.87|1.07|||ANOVA|||Anti-HPV 11|
1700297|NCT00988884|3125285|Non-Inferiority or Equivalence|Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.5|Fold difference in GMT|0.97|||<|0.001|2-Sided|95.0|0.88|1.08|||ANOVA|||Anti-HPV 6|
1700298|NCT00988832|3125295|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1700299|NCT00988832|3125297|Superiority or Other|||||||0.0014|||||||ANOVA||||
1700300|NCT00988832|3125298|Superiority or Other|||||||0.0006|||||||ANOVA||||
1700301|NCT00988832|3125299|Superiority or Other|||||||0.0423|||||||ANOVA||||
1700302|NCT00988832|3125300|Superiority or Other|||||||0.0041|||||||ANOVA||||
1700303|NCT00988832|3125301|Superiority or Other|||||||0.0004|||||||ANOVA||||
1700304|NCT00988832|3125302|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1700305|NCT00988442|3125354|Superiority or Other|||||||1||||||Two-sided 5% significance level.|Fisher Exact|||A Fisher's exact test was used to compare the proportion of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL at week 48 between the standard of care and standard of care + enhanced telephone support groups.|
1700306|NCT00988429|3125355|Superiority or Other|||||||0.001|||||||ANCOVA||||
1700307|NCT00988429|3125355|Superiority or Other|||||||0.068|||||||ANCOVA||||
1700308|NCT00988429|3125356|Superiority or Other|||||||0.004|||||||ANCOVA||||
1700309|NCT00988429|3125356|Superiority or Other|||||||0.058|||||||ANCOVA||||
1700310|NCT00988351|3125357|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.51|=|0|2-Sided|95.0|-1.92|0.09||P < 0.05 considered statistically significant|t-test, 2 sided|||participants using PAP (average >=1/2 hour of use) at 6 weeks clinic visit|
1700311|NCT00988351|3125358|Superiority or Other||Mean Difference (Final Values)|0.58|||=|0|2-Sided|95.0|-1.12|2.29|||t-test, 2 sided|||Patients using PAP (average >= 1/2 hour of nightly use) at 6 weeks clinic visit|
1700312|NCT00988351|3125359|Superiority or Other||Mean Difference (Final Values)|0.69|Standard Error of the Mean|0.71|=|0|2-Sided|95.0|-0.73|2.1||< 0.05 criteria for statistical significance|t-test, 2 sided|||Patients using PAP (average >=1/2 hour per nightly use) at 6 weeks clinic visit|
1700313|NCT00988351|3125360|Superiority or Other||Mean Difference (Final Values)|0.4|||=|0|2-Sided|95.0|-1.3|2.1|||t-test, 2 sided|||Patients using PAP (average of >=1/2 hour per night) at 6 weeks clinic visit|
1700314|NCT00988351|3125361|Non-Inferiority or Equivalence|Non-inferiority margin -0.55 (mean hours of APAP arm no lower than 0.55 hours below CPAP arm)|Mean Difference (Final Values)|0.46|Standard Error of the Mean|0.4|=|0|2-Sided|95.0|-0.35|1.26||level of significance <0.05, Power = 0.80|t-test, 2 sided||||
1700315|NCT00988325|3125365|Superiority or Other||Time to Resolution of Fever in Patients|14.5|||=|0|2-Sided|95.0|12.0|20.0||The p-value is for the comparison of the age cohorts (not including Total)|Wilcoxon (Mann-Whitney)||Median time was estimated from the Kaplan-Meier curve (unstratified)||
1700316|NCT00988325|3125367|Superiority or Other||Median time to cessation of viral sheddi|119.0|||=|0|2-Sided|95.0|113.0|230.0||p-value is for the comparison of the age cohorts (treatment groups)|Wilcoxon (Mann-Whitney)|Wilcoxon Test was used for testing homogeneity of survival curves|Median time was estimated from the Kaplan-Meier curve (unstratified)||
1700317|NCT00988247|3125379|Superiority or Other||treatment difference|-0.49||||0.13|2-Sided|95.0|-1.1|0.1|||ANCOVA|ANCOVA with treatment, baseline and pooled center in the model.|||
1700318|NCT00988247|3125380|Superiority or Other||treatment difference|-0.3||||0.143|2-Sided|95.0|-0.7|0.1|||ANCOVA|ANCOVA with treatment, baseline and pooled center in the model.|||
1700319|NCT00988247|3125381|Superiority or Other||LS mean treatment diff from placebo]|-1.1|||<|0.001|2-Sided|95.0|-1.6|-0.6|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.|||
1700320|NCT00988247|3125382|Superiority or Other||LS mean treatment diff from placebo]|-1.09|||<|0.001|2-Sided|95.0|-1.6|-0.6|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.|||
1700321|NCT00988247|3125383|Superiority or Other||LS mean treatment diff from placebo]|-0.96|||<|0.001|2-Sided|95.0|-1.4|-0.5|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.|||
1700322|NCT00988247|3125384|Superiority or Other||LS mean treatment diff from placebo]|-0.97|||<|0.001|2-Sided|95.0|-1.5|-0.5|||ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, treatment, week and the treatment by week interaction.|||
1700323|NCT00988221|3125403|Superiority or Other||Weighted difference|18.0||||1|2-Sided|95.0|5.0|32.0||1.000 is used here as the test was considered as not significant due to the break in the hierarchical testing chain.|Cochran-Mantel-Haenszel|The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids.||The analysis used the Cochran-Mantel-Haenszel test adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids.|
1700580|NCT00982020|3126414|Superiority or Other|||||||0.52||||||The threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model terms included: baseline, baseline age, gender, intervention group, and region.|||
1700324|NCT00988221|3125404|Superiority or Other||Mean Difference (Final Values)|-10.2||||0.0076|2-Sided|95.0|-17.6|-2.7||The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids. The analysis was also adjusted for the pain visual analog scale score at Baseline.|ANOVA||||
1700325|NCT00988221|3125404|Superiority or Other||Adjusted mean - Tocilizumab|-32.4|||||||||||||||
1700326|NCT00988221|3125404|Superiority or Other||Adjusted mean - Placebo|-22.3|||||||||||||||
1700327|NCT00988208|3125431|Superiority or Other||Odds Ratio (OR)|0.884||||0.3975|2-Sided|95.0|0.665|1.176|||Chi-squared||||
1700328|NCT00988208|3125432|Superiority or Other||Hazard Ratio (HR)|1.32||||0.0187|2-Sided|95.0|1.05|1.66|||Log Rank|P-value is based on unstratified log-rank test|||
1700329|NCT00988208|3125433|Superiority or Other||Hazard Ratio (HR)|1.53||||0.0017|2-Sided|95.0|1.17|2.0||p-value is based on unstratified log-rank test|Log Rank||||
1700330|NCT00988156|3125435|Superiority or Other|||||||0.9017|||||||Cochran-Mantel-Haenszel||||
1700331|NCT00988156|3125436|Superiority or Other|||||||0.249|||||||ANCOVA||||
1700332|NCT00988117|3125446|Superiority or Other||pearson's correlation coefficient|0.26||||0.41||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left supplementary motor area falff change|
1700333|NCT00988117|3125446|Superiority or Other||pearson's r correlation|0.18||||0.58||95.0|||||Regression, Linear|||correlation with left premotor / inferior frontal gyri falff change|
1700334|NCT00988117|3125447|Superiority or Other||pearson's correlation coefficient|-0.35||||0.36||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left supplementary motor area falff change|
1700335|NCT00988117|3125447|Superiority or Other||pearson's r correlation coefficient|-0.82|||<|0.01||95.0||||This p-value was not adjusted for multiple comparisons.|Regression, Linear|||correlation with left inferior frontal gyrus / premotor falff change|
1700336|NCT00988117|3125448|Superiority or Other||Tscore|5.19|||<|0.01||95.0||||t-tests were statistically thresholded using the joint probability distribution method to correct for multiple comparisons, p < 0.01 for voxel height and p < 0.05 for cluster extent|t-test, 2 sided|A mask included only those regions where the patients showed abnormally low fALFF at either timepoint relative to a sample of 15 age-matched controls.||"Each voxel’s BOLD signal time series was detrended and transformed to the frequency domain. We divided the sum of the square roots across the 0.01–0.08 Hz range by that across the entire frequency range (0–0.25 Hz).~fALFF group comparisons were evaluated using t-tests corrected for multiple comparisons. To determine if there were treatment-associated changes in brain activity, we compared voxel-wise fALFF in the patients at baseline to post-treatment."|
1700337|NCT00988091|3125449|Superiority or Other||Odds Ratio (OR)|0.71||||0.081|2-Sided|95.0|0.483|1.044||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p <0.05.|Regression, Logistic|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.[|
1700338|NCT00988091|3125450|Superiority or Other||Adjusted mean difference|4.0||||0.116|2-Sided|95.0|-0.99|8.98||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.|
1700339|NCT00988091|3125452|Superiority or Other|||||||0.887||||||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p <0.05.|Cochran-Mantel-Haenszel|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.|
1700340|NCT00988091|3125453|Superiority or Other||Odds Ratio (OR)|0.777||||0.193|2-Sided|95.0|0.532|1.136||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p <0.05.|Regression, Logistic|The analysis included study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.|
1700341|NCT00988091|3125454|Superiority or Other||Adjusted mean difference|2.89||||0.175|2-Sided|95.0|-1.29|7.08||For secondary outcome measures, fixed-sequence testing was used in a sequentially rejective fashion. The a priori threshold for statistical significance was p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||The null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.|
1700342|NCT00988091|3125455|Superiority or Other||Adjusted mean difference|5.33||||0.034|2-Sided|95.0|0.41|10.24||The p-value was not adjusted for multiple comparisons because there was a single treatment comparison for the primary endpoint. The a priori threshold for statistical significance was p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate and study center as a stratification variable.||A treatment difference of >=7.0 mm and a pooled SD of 27.6 mm, requires a sample size of 244 subjects/treatment to complete the trial at 80% power at a two-sided significance level of 5%. To account for 18% dropout rate, the sample size was increased to 298/arm (total of 596). The primary null hypothesis (Ho) is that the effect of the two treatment groups at 26 weeks is equal and the corresponding alternative hypothesis (HA) is that the effect of the two treatment groups at 26 weeks is unequal.|
1700343|NCT00988065|3125458|Superiority or Other||Difference in event rates|0.0||||||95.0|-2.5|2.5|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|Comparison of participants who had Level 1 or Level 2 diagnostic certainty.|
1702851|NCT00946998|3131639|Superiority|||||||0.32|||||||Mixed Models Analysis||||
1700344|NCT00988065|3125458|Superiority or Other||Difference in event rates|2.0||||||95.0|-0.5|5.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).|Comparison of participants who had Level 1 or Level 2 diagnostic certainty.|
1700345|NCT00988065|3125459|Superiority or Other||Difference in event rates|0.0||||||95.0|-2.5|2.5|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).||
1700346|NCT00988065|3125459|Superiority or Other||Difference in event rates|0.7||||||95.0|-1.8|3.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).||
1700347|NCT00988065|3125460|Superiority or Other||Difference in event rates|4.7||||||95.0|2.1|9.3|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).||
1700348|NCT00988065|3125460|Superiority or Other||Difference in event rates|0.7||||||95.0|-1.8|3.7|||||95% confidence interval for the difference in event rates (treatment group minus placebo) according to Miettinen and Nurminen (Statistics in Medicine 1985; 4:213-226).||
1700349|NCT00987935|3125477|Superiority or Other||Hazard Ratio (HR)|0.94|||||2-Sided|95.0|0.593|1.489|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."||
1700350|NCT00987935|3125478|Superiority or Other||Hazard Ratio (HR)|1.186|||||2-Sided|95.0|0.728|1.932|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."||
1700351|NCT00987935|3125482|Superiority or Other||Hazard Ratio (HR)|1.213|||||2-Sided|95.0|0.73|2.014|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."||
1700352|NCT00987935|3125483|Superiority or Other||Hazard Ratio (HR)|1.357|||||2-Sided|95.0|0.802|2.296|||||"Hazard ratio from Cox proportional hazards model stratified by macroscopic vacular invasion, extrahepatic spread, or both present vs both absent.~HR below 1 favors Nintedanib."||
1700353|NCT00987831|3125486|Superiority or Other||Median Difference (Final Values)|30.0||||0.2738|2-Sided|95.0|5.0|95.0||Definition of Moderate Disease was </= 3 BILAG B (moderate) organ scores, no A (severe) scores and SLEDAI </=10. Severe disease was > 3 BILAG B or >/= BILAG A or SLEDAI > 10 or meets definition for severe flare on the SELENA SLEDAI Flare Index|Log Rank||||
1700354|NCT00987467|3125501|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1700355|NCT00987402|3125507|Superiority or Other||||||<|0.05|||||||generalized estimating equation|||Power calculations assumed a 2-sided alpha error of 0.05 and a power of 80%. We performed power calculations using a statistical model for a cluster-randomized trial with 8, 10 or 12 clusters including 6 operating rooms each, with different levels of reduction (10%, 30%, 50%) in surgical site infection rates in the active intervention period. By reaching a sample size of 3133 patients, the study was powered to detect a 30% reduction effect in SSI rates, from 10% to 7%.|
1700356|NCT00986973|3125538|Superiority or Other|||||||0.34|||||||Wilcoxon (Mann-Whitney)||||
1700357|NCT00986973|3125539|Superiority or Other|||||||0.05|||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes|||
1700358|NCT00986973|3125540|Superiority or Other|||||||0.25|||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes|||
1700359|NCT00986973|3125541|Superiority or Other|||||||0.071|||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes|||
1700360|NCT00986973|3125542|Superiority or Other|||||||0.46|||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes|||
1700361|NCT00986973|3125543|Superiority or Other|||||||0.82|||||||Friedman test|Non-parametric test was used to examine neuropsychological outcomes|||
1700362|NCT00986973|3125544|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1700363|NCT00986921|3125549|Superiority or Other|||||||0.001|||||||Chi-squared||||
1700364|NCT00986921|3125550|Superiority or Other|||||||0.49||||||A threshold value of p of 0.05 was considered significant.|Chi-squared|||The null hypothesis was that the groups would vary, with a p values of less than 0.05.|
1700365|NCT00986921|3125551|Superiority or Other||Mean Difference (Final Values)|1.87||||0.05|2-Sided|95.0|0.0|3.0|||t-test, 1 sided|Data was not distributed normally. After log transformation, the log values were distributed normally.|||
1700366|NCT00986856|3125552|Superiority or Other||Mean Difference (Final Values)|-2.8|Standard Deviation|2.0||0.008||95.0|-4.8|-0.8|||Regression, Linear||||
1700367|NCT00986856|3125553|Superiority or Other||Odds Ratio (OR)|12.8||||0.007||95.0|1.5|109.6|||Cochran-Mantel-Haenszel||||
1700368|NCT00986856|3125554|Superiority or Other||Mean Difference (Final Values)|8.5||||0.043||95.0|0.9|83.5|||Cochran-Mantel-Haenszel||||
1700369|NCT00986856|3125555|Superiority or Other|||||||0.1|||||||Cochran-Mantel-Haenszel||||
1700370|NCT00986856|3125556|Superiority or Other||Odds Ratio (OR)|2.7||||0.1|2-Sided|95.0|0.8|8.8|||Cochran-Mantel-Haenszel||||
1700371|NCT00986856|3125557|Superiority or Other||Odds Ratio (OR)|1.7||||0.54|2-Sided|95.0|0.3|8.1|||Cochran-Mantel-Haenszel||||
1700372|NCT00986856|3125558|Superiority or Other||Odds Ratio (OR)|5.7||||0.023||95.0|1.1|28.6|||Cochran-Mantel-Haenszel||||
1700373|NCT00986856|3125559|Superiority or Other||Odds Ratio (OR)|13.2|||<|0.01||95.0|1.4|120.4||Test for the hypothesis of odds ratio equal to 1.|Cochran-Mantel-Haenszel||||
1700374|NCT00986583|3125568|Superiority or Other||Ratio of medians|1.34||||0.018|2-Sided|95.0|1.05|1.72||This is for the primary comparison at 20 minute|ANCOVA||Ratio of medians of myoglobin measured at 20 minute for statin users vs. non-statin users||
1700375|NCT00986453|3125585|Superiority or Other|||||||0.0002|||||||t-test, 2 sided||||
1700376|NCT00986453|3125586|Superiority or Other|||||||0.0776|||||||t-test, 2 sided||||
1700377|NCT00986453|3125587|Superiority or Other|||||||0.0428|||||||t-test, 2 sided||||
1700378|NCT00986453|3125588|Superiority or Other|||||||0.147|||||||t-test, 2 sided||||
1700379|NCT00986453|3125589|Superiority or Other|||||||0.4697|||||||t-test, 2 sided||||
1700382|NCT00986245|3125629|Non-Inferiority or Equivalence|80% power|Mean Difference (Final Values)|0.1|||<|0.05|||||||Sign test|||"The Epworth sleep scale was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."|
1700383|NCT00986245|3125630|Superiority or Other||Mean Difference (Net)|0.4|||<|0.05||||||80% power|Sign test|||"The Early morning off symptoms was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."|
1700384|NCT00986245|3125631|Non-Inferiority or Equivalence|80% power|Mean Difference (Net)|0.2|||<|0.05|||||||Sign test|||"The Nocturnal off-symptoms was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."|
1700385|NCT00986245|3125632|Non-Inferiority or Equivalence|80% power|Mean Difference (Net)|0.3|||<|0.05|||||||Sign test|||"The Overall quality of sleep was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test."|
1700386|NCT00986245|3125633|Non-Inferiority or Equivalence|80% power|Mean Difference (Net)|0.0|||<|0.05|||||||Sign test|||The Hoehn and Yahr stage was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test.|
1700387|NCT00986245|3125634|Non-Inferiority or Equivalence|80% power|Mean Difference (Net)|0.4|||<|0.05|||||||Sign test|||The UPDRS-part3 was compared between the Once-daily of Ropinirole PR arm and the Twice-daily of Ropinirole PR using the Wilcoxon signed rank test.|
1700388|NCT00986180|3125645|Superiority or Other|||||||0.9084|||||||Log Rank||||
1700389|NCT00986180|3125646|Superiority or Other|||||||0.5828|||||||Log Rank||||
1700390|NCT00986180|3125647|Superiority or Other||Odds Ratio (OR)|0.95|||||2-Sided|95.0|0.54|1.67|||||||
1700391|NCT00986180|3125648|Superiority or Other||Odds Ratio (OR)|3.43|||||2-Sided|95.0|1.45|8.11|||||||
1700392|NCT00986180|3125649|Superiority or Other||Odds Ratio (OR)|1.74|||||2-Sided|95.0|1.17|2.57|||||||
1700393|NCT00986180|3125650|Superiority or Other||Odds Ratio (OR)|1.38|||||2-Sided|95.0|0.92|2.06|||||||
1700394|NCT00986180|3125652|Superiority or Other|||||||0.1541|||||||Fisher Exact||||
1700395|NCT00986180|3125653|Superiority or Other|||||||0.1454|||||||Fisher Exact||||
1700396|NCT00986180|3125655|Superiority or Other|||||||0.4679|||||||Cochran-Mantel-Haenszel||||
1700397|NCT00986180|3125657|Superiority or Other|||||||0.0401|||||||Cochran-Mantel-Haenszel||||
1700398|NCT00986180|3125659|Superiority or Other|||||||0.5208|||||||Cochran-Mantel-Haenszel||||
1700399|NCT00986180|3125661|Superiority or Other|||||||0.7201|||||||Cochran-Mantel-Haenszel||||
1700400|NCT00986180|3125662|Superiority or Other|||||||0.4882|||||||Wilcoxon (Mann-Whitney)||||
1700401|NCT00986180|3125663|Superiority or Other|||||||0.7246|||||||Wilcoxon (Mann-Whitney)||||
1700402|NCT00986180|3125664|Superiority or Other|||||||0.6137|||||||Wilcoxon (Mann-Whitney)||||
1700403|NCT00986180|3125665|Superiority or Other|||||||0.5411|||||||Wilcoxon (Mann-Whitney)||||
1700404|NCT00986180|3125666|Superiority or Other|||||||0.3147|||||||Wilcoxon (Mann-Whitney)||||
1700405|NCT00986180|3125667|Superiority or Other|||||||0.479|||||||Wilcoxon (Mann-Whitney)||||
1700406|NCT00986180|3125668|Superiority or Other|||||||0.7846|||||||Wilcoxon (Mann-Whitney)||||
1700407|NCT00986180|3125669|Superiority or Other|||||||0.8495|||||||Wilcoxon (Mann-Whitney)||||
1700408|NCT00986180|3125670|Superiority or Other|||||||0.4115|||||||Wilcoxon (Mann-Whitney)||||
1700409|NCT00986180|3125671|Superiority or Other|||||||0.888|||||||Wilcoxon (Mann-Whitney)||||
1700410|NCT00986180|3125672|Superiority or Other||Mean Difference (Final Values)|1.6|Standard Error of the Mean|7.02||0.8226|2-Sided|95.0|-12.2|15.4|||ANCOVA||||
1700411|NCT00986180|3125673|Superiority or Other||Mean Difference (Final Values)|-11.6|Standard Error of the Mean|29.03||0.6897|2-Sided|95.0|-68.6|45.4|||ANCOVA||||
1700412|NCT00986180|3125674|Superiority or Other||Mean Difference (Final Values)|-5.1|Standard Error of the Mean|15.82||0.7491|2-Sided|95.0|-36.1|26.0|||ANCOVA||||
1700413|NCT00986180|3125675|Superiority or Other||Mean Difference (Final Values)|-2.5|Standard Error of the Mean|9.3||0.7882|2-Sided|95.0|-20.8|15.8|||ANCOVA||||
1700414|NCT00986180|3125676|Superiority or Other||Mean Difference (Final Values)|-1.6|Standard Error of the Mean|6.08||0.7973|2-Sided|95.0|-13.5|10.4|||ANCOVA||||
1700415|NCT00986180|3125677|Superiority or Other||Mean Difference (Final Values)|-1.6|Standard Error of the Mean|29.75||0.9562|2-Sided|95.0|-60.1|56.8|||ANCOVA||||
1700416|NCT00986180|3125678|Superiority or Other||Mean Difference (Final Values)|0.8|Standard Error of the Mean|9.24||0.9282|2-Sided|95.0|-17.3|19.0|||ANCOVA||||
1700417|NCT00986180|3125679|Superiority or Other||Mean Difference (Final Values)|1.8|Standard Error of the Mean|6.08||0.7691|2-Sided|95.0|-10.1|13.7|||ANCOVA||||
1700418|NCT00986180|3125680|Non-Inferiority or Equivalence|The sample size was recalculated due to Amendment INT-1. The non-inferiority margin for SPID120 was set as 120. The common standard deviation for the SPID120 data was estimated to be 230. Seventy nine subjects in each arm would have 90% power to demonstrate the non-inferiority of NUCYNTA to oxycodone IR with a 1-sided significance level of 0.025. This would have required enrollment of total 158 mITT subjects for each stratum. The original sample size (292 mITT subjects) was derived for SPID72.|Mean Difference (Final Values)|-0.6|Standard Error of the Mean|16.02||0.9703|2-Sided|95.0|-32.1|30.9|||ANCOVA||||
1700419|NCT00986154|3125681|Superiority or Other||Hazard Ratio (HR)|0.81||||0.004|2-Sided|95.0|0.705|0.936|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose|"Safety Analysis set includes all randomized subjects who received at least one dose of study drug.~Null hypothesis (LMW) heparin/edoxaban will be comparable to (LMW) heparin/warfarin in preventing recurrence of major or clinically relevant non-major bleeding."|
1700420|NCT00986154|3125682|Superiority or Other||Hazard Ratio (HR)|1.0||||0.9933|2-Sided|95.0|0.832|1.2|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose.||
1700421|NCT00986154|3125683|Non-Inferiority or Equivalence|The study was designed to accumulate approximately 220 Overall primary efficacy events in the mITT (modified Intent to Treat) Analysis Set. Assuming equal efficacy (Hazard Ratio = 1.00), a total of 220 events gave a power of 85% to demonstrate that (LMW) heparin/edoxaban was non-inferior to the comparator, considering a relative non-inferiority margin of 1.5 (two sided α=0.05).|Hazard Ratio (HR)|0.89|||<|0.0001|2-Sided|95.0|0.703|1.128|||Regression, Cox||Time to 1st event analyzed by Cox proportional hazards with terms treatment group, randomization stratification factors: Presenting Diagnosis (PE with/without DVT, DVT only); Baseline risk factors (temp factors; all others); Need for reduced dose|(LMW) heparin/edoxaban will be non-inferior to (LMW) heparin/warfarin in preventing recurrence of acute, symptomatic VTE following initial index event. (LMW) Heparin/edoxaban was considered non-inferior to the standard therapy ([LMW] heparin/warfarin) if the upper limit of the two-sided 95% confidence interval (CI) for the Hazard Ratio ([LMW] heparin/edoxaban to standard therapy) was less than 1.5. Events included in Overall study period if occurred on or after randomization date up to Day 365.|
1700422|NCT00985985|3125701|Superiority or Other||Odds Ratio (OR)|1.82||||0.0565|2-Sided|95.0|0.99|3.32|||Cochran-Mantel-Haenszel||Odds Ratio based on logistic model (adjusted by center).|Null hypothesis considered no treatment difference in the smoking cessation success rate for the active treatment versus its matching placebo.|
1700423|NCT00985985|3125701|Superiority or Other||Odds Ratio (OR)|1.22||||0.3851|2-Sided|95.0|0.78|1.92|||Cochran-Mantel-Haenszel||Odds Ratio based on logistic model (adjusted by center)|Null hypothesis considered no treatment difference in the smoking cessation success rate for the active treatment versus its matching placebo.|
1700424|NCT00985959|3125707|Superiority or Other||Overall response rate (%)|69.8|Standard Error of the Mean|4.9|<|0.0001|2-Sided|95.0|58.9|79.2||Significance level 5% one-tailed. Threshold response rate 35%|Binominal test||||
1700425|NCT00985751|3125746|Non-Inferiority or Equivalence|The 95% CI for the difference between groups in the percentage of subjects with rectal temperature > 40.0°C within the 7-day follow-up period following primary vaccination was computed for the GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature >40.0°C would be detected if the 95% CIs included 0 and non-inferiority would be express|Difference in percentage|0.97|||||2-Sided|95.0|-6.1|5.32||||||"Fever >40°C-non-inferiority:~To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine GSK 2189242A (pooled groups) versus Synflorix™ vaccine (GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever > 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination."|
1700426|NCT00985751|3125747|Non-Inferiority or Equivalence|The 95% CI for the difference between groups in the percentage of subjects with rectal temperature > 40.0°C within the 7-day follow-up period following primary vaccination was computed for the Synflorix/GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature >40.0°C would be detected if the 95% CIs included 0 and non-inferiority would|Difference in percentage|0.97|||||2-Sided|95.0|-6.1|5.32||||||"Fever >40°C-non-inferiority:~To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine (GSK 2189242A) combined with Synflorix™ vaccine (pooled groups) versus Synflorix™ vaccine (Synflorix/GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever > 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination."|
1700427|NCT00985725|3125756|Superiority or Other||Mean Difference (Final Values)|-4.4||||0.1731|2-Sided|95.0|-10.9|2.0|||ANCOVA||||
1700428|NCT00985725|3125761|Superiority or Other||Mean Difference (Final Values)|-7.0||||0.0012|2-Sided|95.0|-11.1|-2.8|||ANCOVA|||Organization of materials subscale|
1700429|NCT00985725|3125761|Superiority or Other||Mean Difference (Final Values)|-4.9||||0.0357|2-Sided|95.0|-9.4|-0.3|||ANCOVA|||Task monitor subscale|
1700430|NCT00985725|3125761|Superiority or Other||Mean Difference (Final Values)|-7.5||||0.001|2-Sided|95.0|-11.9|-3.1|||ANCOVA|||Plan/Organize subscale|
1700431|NCT00985725|3125761|Superiority or Other||Mean Difference (Final Values)|-9.1||||0.0001|2-Sided|95.0|-13.7|-4.5|||ANCOVA|||Working memory subscale|
1700432|NCT00985725|3125761|Superiority or Other||Mean Difference (Final Values)|-8.6||||0.0002|2-Sided|95.0|-12.9|-4.2|||ANCOVA|||Initiate subscale|
1700433|NCT00985725|3125761|Superiority or Other||Mean Difference (Final Values)|-9.0||||0.0002|2-Sided|95.0|-13.7|-4.3|||ANCOVA|||Metacognition index|
1700434|NCT00985725|3125761|Superiority or Other||Mean Difference (Final Values)|-3.2||||0.1014|2-Sided|95.0|-7.0|0.6|||ANCOVA|||Self-monitor subscale|
1700435|NCT00985725|3125761|Superiority or Other||Mean Difference (Final Values)|-3.7||||0.0793|2-Sided|95.0|-7.9|0.4|||ANCOVA|||Emotional control subscale|
1700436|NCT00985725|3125761|Superiority or Other||Mean Difference (Final Values)|-5.6||||0.009|2-Sided|95.0|-9.8|-1.4|||ANCOVA|||Shift subscale|
1700437|NCT00985725|3125761|Superiority or Other||Mean Difference (Final Values)|-4.2||||0.0204|2-Sided|95.0|-7.7|-0.7|||ANCOVA|||Inhibit subscale|
1700438|NCT00985725|3125761|Superiority or Other||Mean Difference (Final Values)|-5.1||||0.0181|2-Sided|95.0|-9.4|-0.9|||ANCOVA|||Behavioral recognition index|
1700439|NCT00985725|3125762|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.0465|2-Sided|95.0|-3.7|0.0|||ANCOVA||||
1700440|NCT00985725|3125763|Superiority or Other||Mean Difference (Final Values)|-8.0||||0.0009|2-Sided|95.0|-12.7|-3.3|||ANCOVA||||
1700441|NCT00985712|3125764|Superiority or Other|||||||0.1187|||||||Wilcoxon (Mann-Whitney)||||
1700442|NCT00985712|3125765|Superiority or Other|||||||0.9817|||||||Wilcoxon (Mann-Whitney)||||
1700443|NCT00985712|3125766|Superiority or Other|||||||0.907|||||||ANCOVA|Analysis of covariance (ANCOVA) was adjusted for baseline values.|||
1700444|NCT00985712|3125767|Superiority or Other|||||||0.2026||||||P-value is for HbA1c ≤7.5%.|Chi-squared||||
1700445|NCT00985712|3125767|Superiority or Other|||||||0.3551||||||P-value is for HbA1c ≤7.0%.|Chi-squared||||
1700446|NCT00985712|3125768|Superiority or Other||LS Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.11||0.6692|2-Sided|95.0|-0.17|0.26|||Mixed Models Analysis|The model details are given in the section of Measure Description.||Superiority criterion is met if the upper limit of Confidence Interval (CI) is below zero.|
1700739|NCT00977197|3126935|Superiority or Other|||||||0.097||||||Intent to Treat analysis; not adjusted for age and gender.|Chi-squared||||
1700447|NCT00985543|3125817|Non-Inferiority or Equivalence|Results are considered statistically significant at p<0.05 or when 90% confidence intervals do not cross the value 1. No adjustments are made for multiple comparisons.|||||<|0.05|||||||maximum likelihood regression|||Dosing regimens lopinavir/ritonavir 200/150mg BID (Phase 2) and lopinavir/ritonavir 200/50mg BID (Phase 3) will be considered equivalent to lopinavir/ritonavir 400/100mg BID (Phase 1) if the 90% confidence interval (CI) for the mean AUC0–12h ratio and maximum concentration (Cmax) ratio lie between 0.80 and 1.25.|
1700448|NCT00985504|3125820|Superiority or Other|||||||0.724|||||||Fisher Exact||||
1700449|NCT00985504|3125821|Superiority or Other|||||||0.691|||||||Log Rank|||The log-rank test was conducted using Kaplan-Meier Product-Limit method.|
1700450|NCT00985504|3125822|Superiority or Other|||||||0.776|||||||Fisher Exact||||
1700451|NCT00985504|3125823|Superiority or Other|||||||0.517||||||This is the p-value for the Item 5 (Days Underproductive) Score.|ANCOVA|ANCOVA main effect F test|||
1700452|NCT00985504|3125823|Superiority or Other|||||||0.719||||||This is the p-value for the Item 4 (Days Lost) Score.|ANCOVA|ANCOVA main effect F test|||
1700453|NCT00985504|3125823|Superiority or Other|||||||0.443||||||This is the p-value for the Item 3 (Social) Score.|ANCOVA|ANCOVA main effect F test|||
1700454|NCT00985504|3125823|Superiority or Other|||||||0.451||||||This is the p-value for the Item 2 (Family) Score.|ANCOVA|ANCOVA main effect F test|||
1700455|NCT00985504|3125823|Superiority or Other|||||||0.491||||||This is the p-value for the Item 1 (Work) Score.|ANCOVA|ANCOVA main effect F test|||
1700456|NCT00985504|3125823|Superiority or Other|||||||0.821||||||This is the p-value for the SDS Total Score.|ANCOVA|ANCOVA main effect F test|||
1700457|NCT00985504|3125824|Superiority or Other|||||||0.431||||||This is the p-value for the Sharpness/Mental Acuity Score.|ANCOVA|ANCOVA main effect F test|||
1700458|NCT00985504|3125824|Superiority or Other|||||||0.808||||||This is the p-value for the Ability to Find Words Score.|ANCOVA|ANCOVA main effect F test|||
1700459|NCT00985504|3125824|Superiority or Other|||||||0.404||||||This is the p-value for the Ability to Remember/Recall Information Score.|ANCOVA|ANCOVA main effect F test|||
1700460|NCT00985504|3125824|Superiority or Other|||||||0.737||||||This is the p-value for the Ability to Focus/Sustain Attention Score.|ANCOVA|ANCOVA main effect F test|||
1700461|NCT00985504|3125824|Superiority or Other|||||||0.457||||||This is the p-value for the Energy Score.|ANCOVA|ANCOVA main effect F test|||
1700462|NCT00985504|3125824|Superiority or Other|||||||0.657||||||This is the p-value for the Wakefulness/Alertness Score.|ANCOVA|ANCOVA main effect F test|||
1700463|NCT00985504|3125824|Superiority or Other|||||||0.882||||||This is the p-value for the Motivation/Interest/Enthusiasm Score.|ANCOVA|ANCOVA main effect F test|||
1700464|NCT00985504|3125824|Superiority or Other|||||||0.91||||||This is the p-value for the Total Score.|ANCOVA|ANCOVA main effect F test|||
1700465|NCT00985504|3125825|Superiority or Other|||||||0.224||||||This is the p-value for the Item 8 (Inability to Feel) score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700466|NCT00985504|3125825|Superiority or Other|||||||0.88||||||This is the p-value for the Total Score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700467|NCT00985504|3125826|Superiority or Other|||||||0.41|||||||Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700468|NCT00985504|3125827|Superiority or Other|||||||0.723||||||This is the p-value for the PGI-I.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700469|NCT00985504|3125828|Superiority or Other|||||||0.599||||||This is the p-value for the Affect score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700470|NCT00985504|3125828|Superiority or Other|||||||0.822||||||This is the p-value for the Sexual Functioning score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700471|NCT00985504|3125828|Superiority or Other|||||||0.466||||||This is the p-value for the Sleep score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700472|NCT00985504|3125828|Superiority or Other|||||||0.059||||||This is the p-value for the Weight Gain score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700473|NCT00985504|3125828|Superiority or Other|||||||0.226||||||This is the p-value for the Cognitive Functioning score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700474|NCT00985504|3125828|Superiority or Other|||||||0.184||||||This is the p-value for the Motivation and Interest score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700475|NCT00985504|3125828|Superiority or Other|||||||0.119||||||This is the p-value for the Energy Level score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700476|NCT00985504|3125828|Superiority or Other|||||||0.157||||||This is the p-value for the Total Score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700477|NCT00985504|3125829|Superiority or Other|||||||0.945||||||This is the p-value for Other Items Total Score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700478|NCT00985504|3125829|Superiority or Other|||||||0.489||||||This is the p-value for Emotional Items Total Score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700479|NCT00985504|3125829|Superiority or Other|||||||0.665||||||This is the p-value for the Behavior Items Total Score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700480|NCT00985504|3125829|Superiority or Other|||||||0.504||||||This is the p-value for Cognition Items Total Score.|Mixed Models Analysis|The “Kenward-Roger approximation” was used in the MMRM model.|||
1700481|NCT00985504|3125830|Superiority or Other||Mean Difference (Final Values)|-0.38||||0.612|2-Sided|95.0|-1.87|1.1|||Mixed Models Analysis|"The Kenward-Roger approximation was used in the MMRM model."|||
1700482|NCT00985439|3125845|Superiority or Other||Mean Difference (Net)|11.407|Standard Error of the Mean|2.643|<|0.001|2-Sided|95.0|6.195|16.619|||ANCOVA||||
1700606|NCT00980980|3126507|Superiority or Other|||||||0.01|||||||Proportional-hazards models|Proportional-hazards models with shared frailties accounted for clustering within hospitals.|||
1700483|NCT00985010|3125916|Superiority or Other||Mean Difference (Final Values)|23.05|Standard Deviation|10.72||0.05||95.0|||||Wilcoxon (Mann-Whitney)||The difference is between manganese levels of women minus manganese levels of men.|Laboratory results were expressed in means and standard deviations. Between group comparisons (female versus male values) were made with the Mann-Whitney U test using the Statistical Package for Social Sciences (SPSS) program version 10 (SPSS Inc., North Carolina, USA).|
1700484|NCT00985010|3125917|Superiority or Other||Mean Difference (Final Values)|15.0|Standard Deviation|5.0||0.05|||||||Chi-squared||The difference is between the percentage of deaths (males versus females) after six months in the patients with hepatic encephalophathy.|Clinical evolution was reported as percentage (still alive or death after six months of follow up).|
1700485|NCT00984867|3125918|Superiority or Other||Risk Difference (RD)|18.7|Standard Error of the Mean|41.2|||2-Sided|95.0|11.1|26.4||||||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0.|
1700486|NCT00984867|3125919|Superiority or Other||Mean Difference (Final Values)|-14.82|Standard Error of the Mean|3.516|||2-Sided|95.0|-21.73|-7.9||||||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group|
1700487|NCT00984867|3125920|Superiority or Other||Mean Difference (Final Values)|-0.86|Standard Error of the Mean|1.4659||0.5583||95.0|-3.75|2.03||Not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group|
1700488|NCT00984867|3125921|Superiority or Other||Mean Difference (Final Values)|-27.92|Standard Error of the Mean|3.32|<|0.0001|2-Sided|95.0|-34.45|-21.4||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group|
1700489|NCT00984867|3125922|Superiority or Other||Mean Difference (Final Values)|-0.83|Standard Error of the Mean|0.1106|<|0.0001|2-Sided|95.0|-1.05|-0.62||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group|
1700490|NCT00984867|3125923|Superiority or Other||Mean Difference (Final Values)|-1.89|Standard Error of the Mean|0.2466|<|0.0001|2-Sided|95.0|-2.37|-1.4||Significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group|
1700491|NCT00984867|3125924|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.072|<|0.0001|2-Sided|95.0|-0.62|-0.34||Significant at alpha=0.05 (2-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives, based on data from both strata combined|ANCOVA|with treatment group and stratum as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0. The study consisted of two strata: sitagliptin monotherapy group and sitagliptin plus metformin group|
1700492|NCT00984698|3125929|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm|
1700493|NCT00984698|3125930|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||Analysis must be qualified by small sample size, worse baseline symptom severity in CBSRT arm, and greater levels of attrition in PCGT arm|
1700494|NCT00984659|3125935|Superiority or Other||Median Difference (Final Values)|0.08||||0.08||95.0|-0.02|0.19||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparison of mean SOBDA score for Participant-Completed mMRC responders and non-responders|ANCOVA||||
1700495|NCT00984659|3125935|Superiority or Other||Median Difference (Final Values)|0.03||||0.535||95.0|-0.08|0.15||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for Physician-Completed mMRC responders and non-responders|ANCOVA||||
1700496|NCT00984659|3125936|Superiority or Other||Median Difference (Final Values)|0.3|||<|0.001|2-Sided|95.0|0.21|0.4||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for CRQ-SAS Dyspnea Domain responders and non-responders|ANCOVA||||
1700497|NCT00984659|3125937|Superiority or Other||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.14|0.34||ANCOVA adjusted for age, gender, and SOBDA Baseline score; comparision of mean SOBDA score for CGI-C responders and non-responders|ANCOVA||||
1700498|NCT00984659|3125941|Superiority or Other||Mean Difference (Final Values)|0.08||||0.307||95.0|-0.07|0.23||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Visit 3/PD|ANCOVA||||
1700499|NCT00984659|3125941|Superiority or Other||Mean Difference (Final Values)|0.06||||0.18||95.0|-0.03|0.15||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 43|ANCOVA||||
1700500|NCT00984659|3125941|Superiority or Other||Mean Difference (Final Values)|0.13|||<|0.001||95.0|0.08|0.18||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 36|ANCOVA||||
1700501|NCT00984659|3125941|Superiority or Other||Mean Difference (Final Values)|0.11|||<|0.001||95.0|0.06|0.17||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 29|ANCOVA||||
1700502|NCT00984659|3125941|Superiority or Other||Mean Difference (Final Values)|0.11|||<|0.001||95.0|0.06|0.16||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 22|ANCOVA||||
1700503|NCT00984659|3125941|Superiority or Other||Median Difference (Final Values)|0.12|||<|0.001||95.0|0.06|0.19||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 15|ANCOVA||||
1700504|NCT00984659|3125941|Superiority or Other||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.18|0.31||ANCOVA adjusted for age, gender, and SOBDA Baseline score; difference between responders and non-responders during Week prior to Day 8|ANCOVA||||
1700505|NCT00984659|3125943|Superiority or Other|||||||0.008||||||ANCOVA adjusted for age, gender, and percent predicted FEV1 at Screening|ANCOVA||||
1700506|NCT00984659|3125944|Superiority or Other||||||<|0.001||||||ANCOVA adjusted for age, gender, and percent predicted FEV1 at Screening.|ANCOVA||||
1700507|NCT00984659|3125945|Superiority or Other||||||<|0.001||||||Analysis of covariance (ANCOVA) adjusted for age, gender, and percent predicted Forced Expiratory volume in one second (FEV1) at Screening.|ANCOVA||||
1700508|NCT00984659|3125949|Superiority or Other||Mean Difference (Final Values)|0.01||||0.713|2-Sided|95.0|-0.03|0.05|||t-test, 2 sided||||
1700509|NCT00984620|3125959|Superiority or Other|||||||0.1397||||||Compare 120 MG Faldaprevir 120mg (24 Weeks) over 120 MG Faldaprevir 120mg (12 Weeks) using log−rank test.|Log Rank||||
1700510|NCT00984620|3125961|Superiority or Other||Adjusted percent difference|4.78||||0.512|2-Sided|95.0|-9.0|18.6|||Cochran-Mantel-Haenszel|Based on an Cochran−Mantel−Haenszel method adjusted by HCV genotype (1a and 1b only).|p−value presented is 2−sided. The percent differences and p−values are based on a comparison to the Faldaprevir 120mg (12 Weeks).||
1700511|NCT00984620|3125962|Superiority or Other||Adjusted percent difference|3.24||||0.588|2-Sided|95.0|-8.1|14.6|||Cochran-Mantel-Haenszel|Based on an Cochran−Mantel−Haenszel method adjusted by HCV genotype (1a and 1b only).|p−value presented is 2−sided. The percent differences and p−values are based on a comparison to the Faldaprevir 120mg (12 Weeks).||
1700512|NCT00984620|3125963|Superiority or Other||Adjusted percent difference|2.99||||0.676|2-Sided|95.0|-10.6|16.6|||Cochran-Mantel-Haenszel|Based on an Cochran−Mantel−Haenszel method adjusted by HCV genotype (1a and 1b only).|p−value presented is 2−sided. The percent differences and p−values are based on a comparison to the Faldaprevir 120mg (12 Weeks).||
1700513|NCT00984620|3125964|Superiority or Other||Adjusted percent difference|5.48||||0.417|2-Sided|95.0|-7.3|18.3|||Cochran-Mantel-Haenszel|Based on an Cochran−Mantel−Haenszel method adjusted by HCV genotype (1a and 1b only).|p−value presented is 2−sided. The percent differences and p−values are based on a comparison to the Faldaprevir 120mg (12 Weeks).||
1700514|NCT00984620|3125965|Superiority or Other||Adjusted percent difference|9.02||||0.229|2-Sided|95.0|-5.3|23.3|||Cochran-Mantel-Haenszel|Based on an Cochran−Mantel−Haenszel method adjusted by HCV genotype (1a and 1b only).|p−value presented is 2−sided. The percent differences and p−values are based on a comparison to the Faldaprevir 120mg (12 Weeks).||
1700515|NCT00984620|3125966|Superiority or Other||Adjusted percent difference|-1.25||||0.855|2-Sided|95.0|-14.3|11.8|||Cochran-Mantel-Haenszel|Based on an Cochran−Mantel−Haenszel method adjusted by HCV genotype (1a and 1b only).|p−value presented is 2−sided. The percent differences and p−values are based on a comparison to the Faldaprevir 120mg (12 Weeks).||
1700516|NCT00984282|3126008|Superiority or Other||Difference in response rate|11.8|||<|0.0001|2-Sided|95.0|7.0|16.5||stratified by age group and region|Cochran-Mantel-Haenszel||Difference of response rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region||
1700517|NCT00984282|3126009|Superiority or Other||Difference of response rates|11.7||||0.0015|2-Sided|95.0|3.9|19.4||stratified by age group and region|Cochran-Mantel-Haenszel||Difference of disease control rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region||
1700518|NCT00984282|3126010|Superiority or Other||Hazard Ratio (HR)|0.557|||||2-Sided|95.0|0.429|0.724|||||||
1700519|NCT00984282|3126010|Superiority or Other||||||<|0.0001|||||||Log Rank|stratified by age group and region|||
1700520|NCT00984282|3126011|Superiority or Other||Hazard Ratio (HR)|0.928|||||2-Sided|95.0|0.713|1.208|||||||
1700521|NCT00984282|3126011|Superiority or Other|||||||0.2892|||||||Log Rank|stratified by age group and region|||
1700522|NCT00984282|3126012|Superiority or Other||Hazard Ratio (HR)|0.587|||||2-Sided|95.0|0.454|0.758|||||||
1700523|NCT00984282|3126012|Superiority or Other||||||<|0.0001||||||stratified by age group (< 60 years, >= 60 years) and region (Europe, North-America, Asia)|Log Rank|||The two treatment groups were compared using a stratified one-sided log rank test with an overall alpha of 0.01 stratified by age group and region. The null hypothesis that both treatment arms have the same PFS distribution will be tested against the alternative hypothesis that the distribution of PFS times in the sorafenib arm is different from the control arm according to the Lehmann alternative, which is equivalent to the assumption of proportional hazards of the treatment arms.|
1700524|NCT00984126|3126033|Superiority or Other||Incidence rate|0.0|||||1-Sided|95.0||1.4||||||A one-sided 95% upper confidence limit was based on an exact calculation for a binomial distribution.|
1700525|NCT00984022|3126037|Superiority or Other|||||||0.847|||||||Fisher Exact|||Fisher's exact test was used to compare the percentage of individuals achieving a 30% or greater reduction in cellulitis surface area between the Iodoform and Aquacel groups.|
1700526|NCT00984022|3126038|Superiority or Other|||||||0.043||||||Main effect for type of dressing.|ANOVA|||Repeated measures ANOVA using 2 X 2 factorial design, with one between-subjects factor (Group) and one within-subjects factor (Time). Null hypothesis is: The type of dressing does not affect patient pain ratings.|
1700527|NCT00984022|3126039|Superiority or Other|||||||0.0003|||||||Fisher Exact|||The percentages achieving 30% or greater reduction in the surface area of the abscess were compared with Fisher's exact test.|
1700528|NCT00983983|3126043|Superiority or Other|||||||0.03|||||||Fisher Exact||||
1700529|NCT00983983|3126044|Superiority or Other|||||||0.0005|||||||Fisher Exact||||
1700530|NCT00983983|3126045|Superiority or Other|||||||0.06|||||||Fisher Exact||||
1700531|NCT00983983|3126047|Superiority or Other|||||||0.07|||||||Mixed Models Analysis|||Change over time in the ALSFRS-R was analyzed using random-slopes models|
1700656|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.324||0.3638||95.0|-0.47|1.11|||ANOVA|||Difference from placebo (including Baseline); Day 8: 0.5 hours post-dose.|
1700532|NCT00983957|3126049|Superiority or Other||Adjusted geometric mean ratio|1.115|||||2-Sided|90.0|1.063|1.171|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.|
1700533|NCT00983957|3126054|Superiority or Other||Adjusted geometric mean ratio|1.059|||||2-Sided|90.0|0.988|1.135|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.|
1700534|NCT00983957|3126057|Superiority or Other||Adjusted geometric mean ratio|1.121|||||2-Sided|90.0|1.018|1.234|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.|
1700535|NCT00983957|3126058|Superiority or Other||Adjusted geometric mean|1.009|||||2-Sided|90.0|0.951|1.07|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.|
1700536|NCT00983957|3126059|Superiority or Other||Adjusted geometric mean ratio|1.071|||||2-Sided|90.0|0.988|1.16|||||Point estimates and 90% CIs for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.|
1700537|NCT00983957|3126060|Superiority or Other||Adjusted geometric mean ratio|1.105|||||2-Sided|90.0|1.023|1.195|||||Point estimates and 90% Confidence Interval (CIs) for treatment differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.|Mixed effect models were fitted to log-transformed data with treatment as a fixed effect, and measurements within each participant as repeated measurements.|
1700538|NCT00983892|3126068|Superiority or Other||Slope|-1.56||||0.03|2-Sided|95.0|-2.97|-0.15|||GEE|Adjusting for baseline symptom severity, caregiver type, week number, and cancer site.|||
1700539|NCT00983580|3126135|Superiority|||||||0.513|||||||t-test, 2 sided||||
1700540|NCT00983580|3126137|Superiority|||||||0.358|||||||Wilcoxon (Mann-Whitney)|||This statistical analysis compares the difference between the number of patients with No adenoma recurrence at 12 months with those with adenoma recurrence at 12 months.|
1700541|NCT00983580|3126138|Superiority|||||||0.448|||||||Chi-squared||||
1700542|NCT00983476|3126152|Superiority or Other||Mean Difference (Final Values)|0.19||||0.83|2-Sided||||||ANOVA||No comparison between groups was conducted because overall model test was NS.||
1700543|NCT00983476|3126153|Superiority or Other||Mean Difference (Final Values)|0.67||||0.51|2-Sided||||||ANOVA||No comparison between groups was conducted because overall model test was NS.||
1700544|NCT00983476|3126154|Superiority or Other||Mean Difference (Final Values)|0.75||||0.47|2-Sided||||||ANOVA||No comparison between groups was conducted because overall model test was NS.||
1700545|NCT00983476|3126155|Superiority or Other||Mean Difference (Final Values)|2.23||||0.11|2-Sided||||||ANOVA||No comparison between groups was conducted because overall model test was NS.||
1700546|NCT00983476|3126156|Superiority or Other||Mean Difference (Final Values)|1.14||||0.32|2-Sided||||||ANOVA||No comparison between groups was conducted because overall model test was not statistically significant.||
1700547|NCT00983476|3126157|Superiority or Other||Slope|4.02||||0.02|2-Sided||||||Mixed Models Analysis||Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .40 (p=.02); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .44 (p=.01).|In the obese sample, difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by time|
1700548|NCT00983476|3126158|Superiority or Other||Slope|2.2||||0.11|2-Sided||||||Mixed Models Analysis||Reference group is Web-based MOVE SMI: In-person MOVE SMI visit x group Beta estimate is .27 (p=.08); Reference group is Web-based MOVE SMI: Usual care plus handouts visit x group Beta estimate is .29 (p=.06).|Difference in Body Mass Index (BMI) by study arm at 6 months after controlling for BMI 6 months prior to baseline using a repeated measures mixed model with arm, time, and the interaction of arm by time|
1700549|NCT00982592|3126322|Superiority or Other||Hazard Ratio (HR)|1.3||||0.253|2-Sided|95.0|0.83|2.05|||Log Rank||||
1700550|NCT00982592|3126324|Superiority or Other||Hazard Ratio (HR)|1.03||||0.874|2-Sided|95.0|0.7|1.54|||Log Rank||||
1700551|NCT00982553|3126325|Superiority||Geometric mean ratios|0.82|||||2-Sided|95.0|0.36|1.85|||||||
1700552|NCT00982553|3126326|Superiority||Geometric mean ratios|1.01|||||2-Sided|95.0|0.87|1.18|||||||
1700553|NCT00982553|3126327|Superiority||Geometric mean ratios|1.16|||||2-Sided|95.0|0.73|1.86|||||||
1700554|NCT00982553|3126328|Superiority||Geometric mean ratios|0.79|||||2-Sided|95.0|0.62|1.0|||||||
1700555|NCT00982423|3126330|Superiority or Other|||||||0.075|||||||t-test, 2 sided|||Comparison between reduced dose Furosemide and baseline dose Furosemide|
1700556|NCT00982423|3126335|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|||Comparison between GFR taken at baseline dose Furosemide (3 weeks) versus normal GFR|
1700557|NCT00982423|3126335|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Comparison between baseline dose of furosemide (3 weeks) versus reduced dose of furosemide (approximately 6 weeks).|
1700558|NCT00982410|3126339|Superiority or Other||Mean Difference (Final Values)|10.28|||<|0.005|2-Sided|95.0|3.93|16.63|||Mixed Models Analysis|Adjusted for baseline CPSS PSE score. Time interval and therapy session block were utilized to model the variance. EUC group was referent.|Adjusted for baseline CPSS PSE score. EUC group was referent. Mean difference = value for CBT minus value for Educational Support group.||
1700740|NCT00977197|3126936|Superiority or Other|||||||0.016|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.|||
1700559|NCT00982410|3126340|Superiority or Other||Mean Difference (Final Values)|4.66|||>|0.05|2-Sided|95.0|-5.0|14.32|||Mixed Models Analysis|Adjusted for baseline pain tolerance. Time interval and therapy session block were utilized to model the variance.|Educational Support group = referent. Estimation parameter = CBT group minus EUC group, adjusted for BL pain tolerance. Cold tolerance distribution had ceiling and floor effects; and, ~20% of participants refused cold tolerance task in follow-up.||
1700560|NCT00982410|3126341|Superiority or Other||||||>|0.05|||||||Mixed Models Analysis|Adjusted for baseline #days illicit drug use. Time interval and therapy session block were utilized to model the variance. EUC group was referent.|||
1700561|NCT00982410|3126342|Superiority or Other||||||<|0.01|||||||Mixed Models Analysis|Adjusted for baseline #days of alcohol use. Time interval and therapy session block were utilized to model the variance.|||
1700562|NCT00982410|3126343|Superiority or Other||Mean Difference (Final Values)|0.25|||<|0.05|2-Sided|95.0|0.034|0.466|||Mixed Models Analysis|Adjusted for baseline WHY MPI General Activity score. Time interval and therapy session block were utilized to model the variance.|Education Support group was referent. Mean difference = value for CBT group minus value for Educational Support group.||
1700563|NCT00982410|3126344|Superiority or Other||Mean Difference (Final Values)|-0.6489|Standard Error of the Mean|0.29|<|0.05|2-Sided|95.0|-1.2255|-0.0722|||Mixed Models Analysis|Adjusted for baseline NRS-1 pain level. Time interval and therapy session block were utilized to model the variance.|EUC (Arm 2) was referent. Estimation parameter = value for Cognitive Behavior Treatment group minus value for Educational Support group.|Ho: There was no difference in average pain level across the follow-up period, between CBT group and Educational support group.|
1700564|NCT00982397|3126345|Non-Inferiority or Equivalence|Ho: p1 ≤ p2 - 0.05 Ha: p1 > p2 - 0.05 Where p1 was the syncopal event free rate at one year post implant by programming VF NID 30/40 and p2 for NID = 18/24. If the null-hypothesis was rejected it was concluded that NID = 30/40 did not decrease the syncope free rate by more than 5% compared to NID = 18/24 and hence was non-inferior.|Risk Difference (RD)|0.0||||0.0013|2-Sided|90.0|-2.7|2.7||P-Value is for non-inferiority|Farrington-Manning||The 90% Confidence Interval is for the difference (p1-p2), where p1=syncope free rate 30/40 arm and p2=syncope free rate 18/24 arm. Estimated value and confidence interval reflect percentages.|The expected syncopal event free rate was 0.984 in both programming groups. alpha, Type I error was 0.05. Power, 1-beta, was 80%. Non-inferiority margin 5% Based on the above assumptions and Farrington-Manning test, a total of 230 subjects was required. By further assuming 15% attrition rate and 5 % of crossover rate, a total of 300 subjects were needed.|
1700565|NCT00982397|3126346|Superiority or Other||||||<|0.0001||||||P-value is for comparison of the observed proportion of successes against a protocol-specified performance criterion of 95%.|Confidence interval and hypothesis test|||P, the expected proportion of successes under the null hypothesis, was 95%. α, the Type I error rate, is 0.025. Power is 90%. Pa, the assumed true proportion of successes, is 99%. Based on the above assumptions, at least 173 subjects with a useable time to VF detection testing were required for this objective. Assuming a 5% rate for the potential non-adherence to the testing protocol, the required enrollment sample size was 183.|
1700566|NCT00982397|3126347|Superiority or Other||||||<|0.0001||||||P-value is for comparison against a performance criterion of 10%.|Exact Binomial|||Using the one-sided one proportion Exact Test in PASS sample size software, a sample size of 76 subjects with 1-month follow-up was calculated to be required for the evaluation of this objective. To ensure adequate testing of the Protecta XT CRT-D device, the 76 subjects must have included at least 34 CRT-D subjects. Assuming an attrition rate of 10%, a sample size of 85 subjects enrolled was calculated to be required.|
1700567|NCT00982397|3126348|Superiority or Other||percentage of participants|97.5|||||2-Sided|95.0|96.1|98.5|||||Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.|This study was designed to include at least 610 patients with VR-ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with a precision of 2%.|
1700568|NCT00982397|3126348|Superiority or Other||percentage of participants|98.5|||||2-Sided|95.0|97.9|99.0|||||Therapy rates were analyzed using competing risks survival analysis methods, accounting for death as a competing risk.Therapy incidence rates were estimated using cumulative incidence functions and reported with 95% confidence interval.|The study was designed to include at least 1,131 patients with DR/CRT-D ICD devices in order to estimate the inappropriate shock free rate at 1 year post-implant with 1% precision.|
1700569|NCT00982319|3126351|Superiority|||||||0.32|||||||Wilcoxon (Mann-Whitney)||||
1700570|NCT00982111|3126403|Superiority or Other (legacy)||Hazard Ratio (HR)|1.18||||0.0459|2-Sided|95.0|1.0|1.39|||Log Rank||||
1700571|NCT00982111|3126404|Superiority or Other (legacy)||Odds Ratio (OR)|0.96||||0.7945|2-Sided|95.0|0.68|1.34|||Cochran-Mantel-Haenszel||||
1700572|NCT00982111|3126405|Superiority or Other (legacy)||Hazard Ratio (HR)|0.96||||0.6647|2-Sided|95.0|0.8|1.16|||Log Rank||||
1700573|NCT00982111|3126406|Superiority or Other (legacy)||Hazard Ratio (HR)|1.01||||0.9561|2-Sided|95.0|0.84|1.21|||Log Rank||||
1700574|NCT00982033|3126407|Superiority or Other|||||||0.9|||||||ANCOVA||||
1700575|NCT00982020|3126408|Superiority or Other|||||||0.436||||||The threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group*visit.|||
1700576|NCT00982020|3126409|Superiority or Other|||||||0.103||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group*visit.|||
1700577|NCT00982020|3126410|Superiority or Other|||||||0.954||||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM analysis terms included baseline, baseline age, gender, intervention group, visit, region, and intervention group*visit.|||
1700578|NCT00982020|3126411|Superiority or Other|||||||0.266||||||The threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included intervention group, visit, region, and intervention group*visit.|||
1700579|NCT00982020|3126412|Superiority or Other|||||||0.008||||||Threshold for statistical significance was 0.05|Mixed Models Analysis|MMRM analysis terms included baseline, intervention group, visit, region, and intervention group*visit.|||
1700741|NCT00977197|3126937|Superiority or Other|||||||0.03||||||Intent to Treat analysis; adjusted for age and gender, rank scale.|ANCOVA||||
1700581|NCT00982020|3126415|Superiority or Other|||||||0.15||||||The threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures analysis terms included baseline BMI, baseline age, gender, intervention group, visit, region, intervention group*visit.|||
1700582|NCT00981825|3126417|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1700583|NCT00981292|3126452|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Mood data was analysed via student t-test.|
1700584|NCT00981292|3126453|Superiority or Other||||||>|0.05|||||||ANCOVA|||Task performance data were analysed by within subjects ANCOVA (treatment) with pre-treatment performance included as a co-variate for each individual task/measure.|
1700585|NCT00981292|3126454|Superiority or Other||||||<|0.05||||||A Bonferroni adjustment was made for multiplicity.|ANOVA|||This data was analysed by two-way repeated measures ANOVA (task [epoch] x treatment). In the case of those analyses that showed a significant main effect of treatment or a task/epoch x treatment interaction, planned comparisons of data from each task or epoch were then made between placebo and each of the EGCG treatment groups using t tests calculated with the Mean Squares Error from the ANOVA.|
1700586|NCT00981253|3126455|Superiority||Mean Difference (Final Values)|0.13||||0.99|2-Sided|95.0|-0.14|0.39|||ANCOVA||||
1700587|NCT00981253|3126455|Superiority||Mean Difference (Final Values)|0.12||||0.99|2-Sided|95.0|-0.22|0.46|||ANCOVA||||
1700588|NCT00981253|3126456|Superiority||Mean Difference (Final Values)|0.46||||0.99|2-Sided|95.0|-0.78|1.74|||ANCOVA||||
1700589|NCT00981253|3126457|Superiority||Mean Difference (Final Values)|0.12||||0.99|2-Sided|95.0|-0.22|0.46|||ANCOVA||||
1700590|NCT00981253|3126458|Superiority||Mean Difference (Final Values)|0.5||||0.95|2-Sided|95.0|-0.14|1.17|||ANCOVA||||
1700591|NCT00981253|3126459|Superiority||Cox Proportional Hazard|0.47|||||2-Sided|95.0|0.24|0.91|||||||
1700592|NCT00981253|3126460|Superiority||||||<|0.05|||||||ANCOVA||||
1700593|NCT00981253|3126461|Superiority||Mean Difference (Final Values)|-10.1|||||2-Sided|95.0|-18.7|-1.5|||||||
1700594|NCT00981084|3126483|Superiority or Other|||||||0.53|||||||t-test, 2 sided|||We used a crossover design to examine whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the Word Generation, yielding a difference score. We conducted an independent samples t-test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.|
1700595|NCT00981084|3126484|Superiority or Other|||||||0.37|||||||t-test, 2 sided|||We used a crossover design to examine whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the Stroop, yielding a difference score. We conducted an independent samples t-test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.|
1700596|NCT00981084|3126485|Superiority or Other|||||||0.33|||||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the CPT, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.|
1700597|NCT00981084|3126486|Superiority or Other||||||=|0|||||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the BVMT delay, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.|
1700598|NCT00981084|3126486|Superiority or Other||||||=|0|||||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the BVMT learning, yeilding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.|
1700599|NCT00981084|3126486|Superiority or Other||||||=|0|||||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the RVLT delay, yielding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.|
1700600|NCT00981084|3126486|Superiority or Other||||||=|0|||||||t-test, 2 sided|||We used a crossover design to exame whether a single dose of armodafinil would improve cognition in MS. For hypothesis testing analyses, we used a statistical approach that accounts for period (session) effects. We subtracted session 2 performance from session 1 performance on the RVLT learning, yeilding a difference score. we conducted an independent samples t test with treatment order as the independent variable (A/P vs. P/A) and the difference score as the dependent variable.|
1700601|NCT00981058|3126492|Superiority or Other (legacy)||Hazard Ratio (HR)|0.844||||0.0061|2-Sided|95.0|0.747|0.953|||Log Rank||||
1700602|NCT00981058|3126493|Superiority or Other (legacy)||Odds Ratio (OR)|1.12||||0.3997|2-Sided|95.0|0.86|1.45|||Cochran-Mantel-Haenszel||||
1700603|NCT00981058|3126494|Superiority or Other (legacy)||Hazard Ratio (HR)|0.851||||0.0201|2-Sided|95.0|0.743|0.975|||Log Rank||||
1700604|NCT00981058|3126495|Superiority or Other (legacy)||Hazard Ratio (HR)|0.842||||0.012|2-Sided|95.0|0.736|0.962|||Log Rank||||
1700605|NCT00981019|3126499|Superiority or Other||||||<|0.05|||||||Chi-squared|||"Study was exploratory, thus no hypotheses had been formalized beforehand.~To analyze repeated measures outcomes (e.g., effect of the four different statistic scenarios on doctors' recommendation of screening, their judgment of screening's effectiveness, etc.), we used the McNemar chi-square test and the Wilcoxon signed-rank test.~To test for order effects (scenarios were randomly presented)Pearson’s chi-square test and the Mann–Whitney U test were used."|
1700607|NCT00980798|3126509|Superiority or Other||Mean Difference (Net)|-0.2365||||0.1212|2-Sided|95.0|-0.5357|0.0627||No adjustment for multiple comparisons necessary, as only 1 primary hypothesis was tested. Threshold for statistical significance was 0.05.|Mixed-model regression analysis|The difference above is presented as the difference OROS hydromorphone HCl minus placebo, so negative scores favour OROS hydromorphone HCl.|The analysis was adjusted for baseline BPI item 5 score, time on study, and whether the primary affected joint was the hip or knee.|The F test for treatment tested the null hypothesis of no treatment difference. Assuming that 3 baseline measures and 7 post baseline measures were collected 81 patients were required per group to detect a difference of 1 point in the BPI measure with 90% power at a significance level of 5%. To allow for a drop-out rate of approximately 40%, the study planned to recruit 135 patients per group (i.e. 270 in total).|
1700608|NCT00980200|3126563|Superiority or Other||Mean Difference (Final Values)|0.125|||<|0.001|2-Sided|95.0|0.08|0.17|||ANCOVA||||
1700609|NCT00980200|3126563|Superiority or Other||Mean Difference (Final Values)|0.102|||<|0.001|2-Sided|95.0|0.057|0.147|||ANCOVA||||
1700610|NCT00980200|3126563|Superiority or Other||Mean Difference (Final Values)|0.14|||<|0.001|2-Sided|95.0|0.095|0.185|||ANCOVA||||
1700611|NCT00980200|3126563|Superiority or Other||Mean Difference (Final Values)|0.094|||<|0.001|2-Sided|95.0|0.049|0.14|||ANCOVA||||
1700612|NCT00980174|3126564|Superiority or Other||||||<|0.0001||||||p-value is adjusted for multiple comparisons by Hochberg method|Van Elteren Rank Test|Adjusted by level of baseline bone mineral density T-score|||
1700613|NCT00980174|3126565|Superiority or Other||Median Difference (Net)|0.9||||0.0144|2-Sided|95.0|0.2|1.6||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo||
1700614|NCT00980174|3126566|Superiority or Other||Mean Difference (Net)|2.3|||<|0.0001|2-Sided|95.0|1.4|3.2||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo||
1700615|NCT00980174|3126567|Superiority or Other||Mean Difference (Net)|2.2|||<|0.0001|2-Sided|95.0|1.3|3.0||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo||
1700616|NCT00980174|3126568|Superiority or Other||Mean Difference (Net)|2.0|||<|0.0001|2-Sided|95.0|1.5|2.6||p-value is adjusted for multiple comparisons by Hochberg method|ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo||
1700617|NCT00980174|3126569|Superiority or Other||Mean Difference (Net)|4.8|||<|0.0001|2-Sided|95.0|4.0|5.6|||ANCOVA|Adjusted by level of baseline bone mineral density T-score|Denosumab - Placebo||
1700618|NCT00980148|3126571|Non-Inferiority or Equivalence|This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The treatment failure rate was assumed to be 3% for both treatments. To test this hypothesis at the one-sided 0.10 significance level with power of 0.90 required 153 study subjects per arm in the per-protocol population.|Risk Difference (RD)|3.2|||||1-Sided|90.0||5.9|||||The risk difference is the percentage in the azithromycin arm with treatment failure minus the percentage in the doxycycline arm with treatment failure. Noninferiority of azithromycin would be supported if the upper 90% confidence limit is below 5%.|This noninferiority study tested the null hypothesis that the failure rate of azithromycin is 5% higher than that of doxycycline against the alternative hypothesis that there is no difference between the two treatments. The one-sided 90% exact confidence interval was used to estimate the difference between the two failures rates.|
1700619|NCT00980057|3126572|Non-Inferiority|The non-inferiority margin is 5.1||||||0.002|||||||t-test, 1 sided||||
1700620|NCT00980057|3126573|Non-Inferiority|The non-inferiority margin is 30||||||0.0002|||||||t-test, 1 sided||||
1700621|NCT00980057|3126574|Non-Inferiority|The non-inferiority margin is 0.3|||||<|0.0001|||||||t-test, 1 sided||||
1700622|NCT00980057|3126575|Non-Inferiority|The non-inferiority margin is 2.5||||||0.0009|||||||t-test, 1 sided||||
1700623|NCT00980057|3126576|Non-Inferiority|The non-inferiority margin is 15|||||<|0.0001|||||||t-test, 1 sided||||
1700624|NCT00980057|3126577|Superiority||||||<|0.0001|||||||t-test, 2 sided||||
1700625|NCT00980057|3126579|Superiority|The pre-specified minimum objective performance criteria was 0.82|||||<|0.0001|||||||t-test, 1 sided||||
1700626|NCT00980057|3126580|Non-Inferiority|The non-inferiority margin was 12%.||||||0.0002|||||||Farrington-Manning test of two ind. prop||||
1700627|NCT00979940|3126609|Superiority or Other|||||||0.97|||||||Chi-squared||||
1700628|NCT00979875|3126620|Superiority or Other||Least Square Mean Difference|-42.14|||<|0.0001|2-Sided|90.0|-56.53|-27.76||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.|||
1700629|NCT00979875|3126620|Superiority or Other||Least Square Mean Difference|-26.43|||<|0.0032|2-Sided|90.0|-40.81|-12.05||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.|||
1700630|NCT00979875|3126620|Superiority or Other||Least Square Mean Difference|-38.93|||<|0.0001|2-Sided|90.0|-53.31|-24.55||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.|||
1700631|NCT00979875|3126621|Superiority or Other||Geometric Least Squares Means Ratio|4.14|||<|0.0001|2-Sided|90.0|3.05|5.6||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.|||
1700657|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.302||0.9964||95.0|-0.68|0.68|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.|
1701676|NCT00966875|3128635|Superiority or Other|||||||0.191||||||P-value is for ACR50-NRI at Week 12.|Fisher Exact||||
1700632|NCT00979875|3126621|Superiority or Other||Geometric Least Squares Means Ratio|5.26|||<|0.0001|2-Sided|90.0|3.88|7.12||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.|||
1700633|NCT00979875|3126621|Superiority or Other||Geometric Least Squares Mean Ratio|2.08|||<|0.0001|2-Sided|90.0|1.7|2.55||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.|||
1700634|NCT00979459|3126678|Non-Inferiority or Equivalence|Administration of a single dose of two 40 mg MK-1006 FCT is similar to a single dose of four 20 mg MK-1006 DFC will be satisfied if the 90% confidence interval for the Cmax geometric mean ratio (FCT/DCF) is contained within (0.70, 1.43).|Geometric mean ratio|1.07|||||2-Sided|90.0|0.92|1.24|||||||
1700635|NCT00979459|3126679|Non-Inferiority or Equivalence|Administration of a single dose of two 40 mg MK-1006 FCT is similar to a single dose of four 20 mg MK-1006 DFC will be satisfied if the 90% confidence interval for the AUC(0 to infinity) geometric mean ratio (FCT/DCF) is contained within (0.70, 1.43).|Geometric mean ratio|0.93|||||2-Sided|90.0|0.86|0.99|||||||
1700636|NCT00979212|3126724|Superiority or Other|||||||0.96||||||One-sided test at significance level of 0.05|Fisher Exact|||Null hypothesis (H0) was that the experimental treatment was not effective vs the alternative hypothesis (HA) that it was. H0: OR ≤ 1 vs. HA: OR > 1, where odds ratio (OR)= [p2*(1- p1)]/ [p1*(1- p2)], p1 denotes the mediastinal clearance rate (MCR) on Induction chemoradiation; p2 denotes the MCR on Induction chemoradiation + panitumumab. Fisher’s exact test was used to compare the MCRs; the 95% confidence interval was calculated using Clopper-Pearson method. 97 patients were required.|
1700637|NCT00979121|3126742|Superiority or Other||Mean Difference (Final Values)|0.0||||0.96||95.0|-1.6|1.5|||ANCOVA|||Ventilator, ICU free, and organ failure free days were analyzed by analysis of variance, utilizing treatment assignment where applicable.|
1700638|NCT00979121|3126743|Superiority or Other||difference in % of pts alive at 60 days|4.0||||0.21|2-Sided|95.0|-2.3|10.2||The monitoring boundaries were designed to have a low probability of stopping for futility before 750 patients. The maximum sample size was 1000 patients. Efficacy stopping was based on mortality; futility stopping was based on mortality and VFDs.|Proc lifetest|Proc lifetest was used to calculate mortality mean and variance due to one subject lost to follow up who was censored.||Hospital mortality to day 60 was estimated using the Kaplan Meier estimate, with patients discharged home before day 60 considered alive at day 60. The analysis was stratified by co-enrolled treatment assignments for 81 patients also enrolled in a randomized clinical trial of two different nutritional strategies. A maximum of 1000 patients were to be enrolled, providing a 92% probability of rejecting the null hypothesis for the effect on mortality if a true difference in mortality was 9%.|
1700639|NCT00978757|3126750|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1700640|NCT00978341|3126802|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.103||0.8203||95.0|-0.22|0.27|||ANOVA|||Difference from placebo (including Baseline); Day 8: 6 hours post-dose.|
1700641|NCT00978341|3126802|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.072||0.3159||95.0|-0.09|0.24|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.|
1700642|NCT00978341|3126802|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.122||0.1881||95.0|-0.42|0.09|||ANOVA|||Difference from placebo (including Baseline); Day 8: 2 hours post-dose.|
1700643|NCT00978341|3126802|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.113||0.3035||95.0|-0.35|0.12|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.|
1700644|NCT00978341|3126802|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.143||0.6222||95.0|-0.37|0.23|||ANOVA|||Difference from placebo (including Baseline); Day 1: 6 hours post-dose.|
1700645|NCT00978341|3126802|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.09||0.4814||95.0|-0.26|0.13|||ANOVA|||Difference from placebo (including Baseline); Day 1: 4 hours post-dose.|
1700646|NCT00978341|3126802|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.054||0.7569||95.0|-0.14|0.1|||ANOVA|||Difference from placebo (including Baseline); Day 1: 2 hours post-dose.|
1700647|NCT00978341|3126803|Superiority or Other||Mean Difference (Final Values)|2.64|Standard Error of the Mean|12.123||0.8314||95.0|-24.0|29.28|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.|
1700648|NCT00978341|3126803|Superiority or Other||Mean Difference (Final Values)|12.58|Standard Error of the Mean|14.603||0.3981||95.0|-17.7|42.87|||ANOVA|||Difference from placebo (including Baseline); Day 8: pre-dose.|
1700649|NCT00978341|3126803|Superiority or Other||Mean Difference (Final Values)|5.39|Standard Error of the Mean|9.738||0.5919||95.0|-16.26|27.04|||ANOVA|||Difference from placebo (including Baseline); Day 1.|
1700650|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.48|Standard Error of the Mean|0.461||0.3163||95.0|-0.52|1.49|||ANOVA|||Difference from placebo (including Baseline); Day 8: 6 hours post-dose.|
1700651|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.48|Standard Error of the Mean|0.491||0.3624||95.0|-0.68|1.64|||ANOVA|||Difference from placebo (including Baseline); Day 8: 5 hours post-dose.|
1700652|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.205||0.6028||95.0|-0.34|0.56|||ANOVA|||Difference from placebo (including Baseline); Day 8: 4 hours post-dose.|
1700653|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.289||0.4213||95.0|-0.44|0.93|||ANOVA|||Difference from placebo (including Baseline); Day 8: 3 hours post-dose.|
1700654|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.355||0.1204||95.0|-0.19|1.39|||ANOVA|||Difference from placebo (including Baseline); Day 8: 2 hours post-dose.|
1700655|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.42|Standard Error of the Mean|0.223||0.1202||95.0|-0.15|0.99|||ANOVA|||Difference from placebo (including Baseline); Day 8: 1 hour post-dose.|
1700658|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.269||0.6394||95.0|-0.53|0.8|||ANOVA|||Difference from placebo (including Baseline); Day 1: 6 hours post-dose.|
1700659|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.269||0.4251||95.0|-0.42|0.88|||ANOVA|||Difference from placebo (including Baseline); Day 1: 5 hours post-dose.|
1700660|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.22||0.8321||95.0|-0.45|0.55|||ANOVA|||Difference from placebo (including Baseline); Day 1: 4 hours post-dose.|
1700661|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.3||0.1862||95.0|-1.18|0.29|||ANOVA|||Difference from placebo (including Baseline); Day 1: 3 hours post-dose.|
1700662|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.48||||0.147||95.0|-0.23|1.2|||ANOVA|||Difference from placebo (including Baseline); Day 1: 2 hours post-dose.|
1700663|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.215||0.4153||95.0|-0.33|0.7|||ANOVA|||Difference from placebo (including Baseline); Day 1: 1 hour post-dose.|
1700664|NCT00978341|3126804|Superiority or Other||Mean Difference (Final Values)|0.36|Standard Error of the Mean|0.386||0.3774||95.0|-0.54|1.27|||ANOVA|||Difference from placebo (including Baseline); Day 1: 0.5 hours post-dose.|
1700665|NCT00978341|3126805|Superiority or Other||Mean Difference (Final Values)|-22.51|Standard Error of the Mean|17.526||0.2293||95.0|-61.79|16.78|||ANOVA|||Difference from placebo; Day 8: 4 hours post-dose (including Baseline).|
1700666|NCT00978341|3126805|Superiority or Other||Mean Difference (Final Values)|4.52|Standard Error of the Mean|15.813||0.7807||95.0|-30.53|39.57|||ANOVA|||Difference from placebo; Day 8: pre-dose (including Baseline).|
1700667|NCT00978341|3126805|Superiority or Other||Mean Difference (Final Values)|-2.26|Standard Error of the Mean|19.06||0.9068||95.0|-41.78|37.27|||ANOVA|||Difference from placebo; Day 1: 4 hours post-dose (including Baseline).|
1700668|NCT00978341|3126806|Superiority or Other||Mean Difference (Final Values)|-1.33|Standard Error of the Mean|0.356||0.0108||95.0|-2.21|-0.44|||ANOVA|||Difference from placebo (including baseline); Day 8.|
1700669|NCT00978341|3126806|Superiority or Other||Mean Difference (Final Values)|-0.78|Standard Error of the Mean|0.638||0.282||95.0|-2.45|0.9|||ANOVA|||Difference from placebo (including baseline); Day 7.|
1700670|NCT00978341|3126806|Superiority or Other||Mean Difference (Final Values)|-1.16|Standard Error of the Mean|0.742||0.1326||95.0|-2.69|0.38|||ANOVA|||Difference from placebo; Day 6.|
1700671|NCT00978341|3126806|Superiority or Other||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.65||0.4589||95.0|-1.83|0.85|||ANOVA|||Difference from placebo; Day 5.|
1700672|NCT00978341|3126806|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.254||0.0697||95.0|-1.11|0.05|||ANOVA|||Difference from placebo (including baseline); Day 4.|
1700673|NCT00978341|3126806|Superiority or Other||Mean Difference (Final Values)|-1.04|Standard Error of the Mean|0.623||0.1065||95.0|-2.33|0.24|||ANOVA|||Difference from placebo (including baseline); Day 3.|
1700674|NCT00978341|3126806|Superiority or Other||Mean Difference (Final Values)|-0.92|Standard Error of the Mean|0.714||0.2101||95.0|-2.39|0.55|||ANOVA|||Difference from placebo (including baseline); Day 2. Combined analysis: values for the two patient groups were analyzed together using ANOVA and/or mixed models.|
1700675|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.354||0.8082||95.0|-0.87|0.69|||ANOVA|||Difference from placebo (including Baseline), Day 8: 48 hours post-dose.|
1700676|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.406||0.9884||95.0|-0.9|0.91|||ANOVA|||Difference from placebo (including Baseline), Day 8: 36 hours post-dose.|
1700677|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.78|Standard Error of the Mean|0.531||0.183||95.0|-2.01|0.45|||ANOVA|||Difference from placebo (including Baseline), Day 8: 24 hours post-dose.|
1700678|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.273||0.029||95.0|-1.29|-0.08|||ANOVA|||Difference from placebo (including Baseline), Day 8: 12 hours post-dose.|
1700679|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.394||0.5266||95.0|-1.13|0.62|||ANOVA|||Difference from placebo (including Baseline), Day 8: 10 hours post-dose.|
1700680|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.33|Standard Error of the Mean|0.419||0.446||95.0|-1.28|0.61|||ANOVA|||Difference from placebo (including Baseline), Day 8: 8 hours post-dose.|
1700681|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.71|Standard Error of the Mean|0.395||0.1078||95.0|-1.62|0.19|||ANOVA|||Difference from placebo (including Baseline), Day 8: 6 hours post-dose.|
1700682|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.293||0.9708||95.0|-0.67|0.65|||ANOVA|||Difference from placebo (including Baseline), Day 8: 5 hours post-dose.|
1700683|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.393||0.9024||95.0|-0.94|0.84|||ANOVA|||Difference from placebo (including baseline), Day 8: 4 hours post-dose.|
1700684|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.311||0.867||95.0|-0.64|0.74|||ANOVA|||Difference from placebo (including baseline), Day 8: 3 hours post-dose.|
1700685|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.189||0.9601||95.0|-0.44|0.42|||ANOVA|||Difference from placebo (including Baseline), Day 8: 2 hours post-dose.|
1700686|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-1.05|Standard Error of the Mean|0.82||0.215||95.0|-2.75|0.65|||ANOVA|||Difference from placebo (including Baseline), Day 8: 1 hour post-dose.|
1700687|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|0.553||0.2843||95.0|-2.2|0.84|||ANOVA|||Difference from placebo (including Baseline), Day 8: 0.5 hours post-dose.|
1700688|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.87|Standard Error of the Mean|0.619||0.1946||95.0|-2.29|0.54|||ANOVA|||Difference from placebo (including Baseline), Day 8: pre-dose.|
1701677|NCT00966875|3128635|Superiority or Other|||||||0.047||||||P-value is for ACR20-NRI at Week 12.|Fisher Exact||||
1700689|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-1.38|Standard Error of the Mean|0.615||0.0614||95.0|-2.84|0.09|||ANOVA|||Difference from placebo (including Baseline), Day 1: 12 hours post-dose.|
1700690|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-1.25|Standard Error of the Mean|0.637||0.0951||95.0|-2.79|0.29|||ANOVA|||Difference from placebo (including Baseline), Day 1: 10 hours post-dose.|
1700691|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.319||0.1531||95.0|-1.25|0.24|||ANOVA|||Difference from placebo (including Baseline), Day 1: 8 hours post-dose.|
1700692|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-1.55|Standard Error of the Mean|0.713||0.0396||95.0|-3.02|-0.08|||ANOVA|||Difference from placebo (including Baseline), Day 1: 6 hours post-dose.|
1700693|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-1.36|Standard Error of the Mean|0.715||0.0694||95.0|-2.83|0.12|||ANOVA|||Difference from placebo (including Baseline), Day 1: 5 hours post-dose.|
1700694|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.93|Standard Error of the Mean|0.694||0.1935||95.0|-2.36|0.5|||ANOVA|||Difference from placebo (including Baseline), Day 1: 4 hours post-dose.|
1700695|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.487||0.4034||95.0|-1.78|0.87|||ANOVA|||Difference from placebo (including Baseline) , Day 1: 3 hours post-dose.|
1700696|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.67|Standard Error of the Mean|0.454||0.1693||95.0|-1.67|0.33|||ANOVA|||Difference from placebo (including Baseline), Day 1: 2 hours post-dose.|
1700697|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.528||0.4811||95.0|-1.54|0.77|||ANOVA|||Difference from placebo (including Baseline), Day 1: 1 hour post-dose.|
1700698|NCT00978341|3126807|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.462||0.6797||95.0|-0.83|1.22|||ANOVA|||Difference from placebo (including Baseline), Day 1: 0.5 hours post-dose.|
1700699|NCT00978120|3126811|Superiority or Other|||||||0.032|||||||Fisher Exact||||
1700700|NCT00978120|3126812|Superiority or Other|||||||0.016|||||||Fisher Exact||||
1700701|NCT00978120|3126813|Superiority or Other|||||||0.006|||||||Fisher Exact||||
1700702|NCT00978120|3126814|Superiority or Other|||||||0.362|||||||Fisher Exact||||
1700703|NCT00978120|3126815|Superiority or Other|||||||0.173|||||||Fisher Exact||||
1700704|NCT00978120|3126816|Superiority or Other|||||||0.245|||||||Fisher Exact||||
1700705|NCT00978120|3126817|Superiority or Other|||||||0.02|||||||Fisher Exact||||
1700706|NCT00978120|3126818|Superiority or Other|||||||0.341|||||||Fisher Exact||||
1700707|NCT00978120|3126819|Superiority or Other|||||||0.004|||||||Fisher Exact||||
1700708|NCT00978120|3126820|Superiority or Other|||||||0.284|||||||Fisher Exact||||
1700709|NCT00978120|3126821|Superiority or Other|||||||0.12|||||||Fisher Exact||||
1700710|NCT00978120|3126822|Superiority or Other|||||||0.47|||||||Fisher Exact||||
1700711|NCT00978120|3126825|Superiority or Other|||||||0.05|||||||Fisher Exact||||
1700712|NCT00978120|3126826|Superiority or Other|||||||0.014|||||||Fisher Exact||||
1700713|NCT00978068|3126828|Superiority or Other||Hazard Ratio (HR)|0.41||||0.004|2-Sided|95.0|0.22|0.76|||Cox Proportional-Hazards|Adjustment for repeated measures in the same patient.|Group 1 represents the numerator in the hazard ratio. Group 2 represents the denominator in the hazard ratio.||
1700714|NCT00978068|3126829|Superiority or Other||Hazard Ratio (HR)|0.31||||0.004|2-Sided|95.0|0.14|0.68|||Cox Proportional-Hazards|Adjustment for repeated measures in same participant.|Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.||
1700715|NCT00978068|3126830|Superiority or Other||Hazard Ratio (HR)|0.71||||0.14|2-Sided|95.0|0.45|1.12|||Cox Proportional-Hazards|Adjustment for repeated measures in the same patient|Group 1 represents the numerator for the hazard ratio. Group 2 represents the denominator for the hazard ratio.||
1700716|NCT00978068|3126831|Superiority or Other||Incidence Rate Ratio|0.8||||0.87|2-Sided|95.0|0.06|11.16|||Negative Binomial Regression||Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.|We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.|
1700717|NCT00978068|3126832|Superiority or Other|||||||0.13|||||||Cox Proportional-Hazards||||
1700718|NCT00978068|3126833|Superiority or Other||Incidence Rate Ratio|0.59||||0.04|2-Sided|95.0|0.36|0.97|||Negative Binomial Regression||Group 1 represents the numerator for the rate ratio. Group 2 represents the denominator for the rate ratio.|We assumed that the incidence of malaria in Group 2 would be 0.70 episodes per person-year and estimated that we would need a sample of 300 participants for the study to have 80% power to show a 35% reduction in the incidence of malaria in Group 1, at a 2-sided significance level of 0.05. We then observed an incidence of malaria in Group 2 that was higher than anticipated (2.19 episodes/person-yr) and revised the sample size to 150 participants, who would be followed for at least 6 months.|
1700719|NCT00978029|3126843|Superiority or Other||Percent Difference|16.9||||0.078|2-Sided|95.0|0.01|33.83|||Fisher Exact||||
1700720|NCT00978029|3126843|Superiority or Other||Percent Difference|6.9||||0.486|2-Sided|95.0|-10.17|23.97|||Fisher Exact||||
1700721|NCT00977938|3126844|Superiority or Other||Risk Difference (RD)|1.03|||||2-Sided|95.0|-0.21|2.28|||||30-month DAPT vs. 12-month DAPT||
1700722|NCT00977938|3126845|Superiority or Other||Hazard Ratio (HR)|0.49|||||2-Sided|95.0|0.15|1.64|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.||
1700723|NCT00977938|3126846|Superiority or Other||Hazard Ratio (HR)|0.91|||||2-Sided|95.0|0.58|1.4|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis||
1700724|NCT00977938|3126847|Superiority or Other||Risk Difference (RD)|1.12||||0.706|2-Sided|95.0|-0.06|2.31|||Farrington-Manning|No formal hypothesis testing was done.|30-month DAPT vs. 12-month DAPT||
1700725|NCT00977938|3126848|Superiority or Other||Hazard Ratio (HR)|0.49||||0.478|2-Sided|95.0|0.15|1.64||This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|This analysis was not powered.|
1700726|NCT00977938|3126849|Superiority or Other||Hazard Ratio (HR)|0.92||||0.722|2-Sided|95.0|0.57|1.47||This analysis was not powered. P-value was stratified according to geographic region, thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|This analysis was not powered.|
1700727|NCT00977938|3126850|Superiority or Other||Risk Difference (RD)|0.86|||||2-Sided|95.0|0.24|1.48|||||30-month DAPT vs. 12-month DAPT||
1700728|NCT00977938|3126851|Superiority or Other||Hazard Ratio (HR)|0.45|||||2-Sided|95.0|0.29|0.69|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis||
1700729|NCT00977938|3126852|Superiority or Other||Hazard Ratio (HR)|0.82|||||2-Sided|95.0|0.7|0.97|||||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis||
1700730|NCT00977938|3126853|Non-Inferiority or Equivalence|Non-inferiority margin of 0.97% (0.0097)|Risk Difference (RD)|-1.05|||<|0.001|1-Sided|97.5||-0.27||One-sided P-value for non-inferiority|Nam and Kwon|P-value was computed for clustered matched pairs based on Nam and Kwon (2009).|Weighted RD and 1-sided 95% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).|The null hypothesis was that DAPT patients treated with DES would have stent thrombosis rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.|
1700731|NCT00977938|3126854|Non-Inferiority or Equivalence|Non-inferiority margin of 2.28% (0.0228)|Risk Difference (RD)|-1.82|||<|0.001|1-Sided|97.5||0.03||One-sided P-value for non-inferiority|Nam and Kwon|P-value was computed for clustered matched pairs based on Nam and Kwon (2009).|Weighted RD and 1-sided 97.5% upper CL were computed for clustered matched pairs based on Nam and Kwon (2009).|The null hypothesis was that DAPT patients treated with DES would have MACCE rate between 0 and 33 months post-index procedure that exceeds that of the control arm (patients treated with BMS) by at least a pre-specified absolute margin of δ.|
1700732|NCT00977938|3126855|Non-Inferiority or Equivalence|The primary safety analysis was a noninferiority analysis performed with the use of the Farrington–Manning risk-difference approach. Assuming an annualized rate for moderate or severe bleeding of 1.9% and an absolute noninferiority margin of 0.8%, at a one-sided alpha level of significance of 0.025, we calculated that a sample size of 9960 patients would give the study 80% power to detect noninferiority.|Risk Difference (RD)|0.96||||0.704|2-Sided|95.0|0.38|1.53||One-sided P-value for non-inferiority|Farrington-Manning||30-month DAPT vs. 12-month DAPT||
1700733|NCT00977938|3126856|Superiority or Other||Hazard Ratio (HR)|0.29|||<|0.001|2-Sided|95.0|0.17|0.48||P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg–Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.|
1700734|NCT00977938|3126857|Superiority or Other||Hazard Ratio (HR)|0.71|||<|0.001|2-Sided|95.0|0.59|0.85||P-value was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine received at the time of randomization, and presence or absence of risk factors for ST; P-value was adjudsted using the Benjamini Hochberg approach.|Log Rank||30-month DAPT vs. 12-month DAPT; HR was stratified according to geographic region (NA, EU, or AU and NZ), thienopyridine drug received at the time of randomization, and presence or absence of risk factors for stent thrombosis.|The primary efficacy analysis was a superiority analysis. We controlled the two-sided family-wise error rate of 0.05 across the two coprimary end points using the Hochberg–Benjamini method. With this method, the null hypothesis of randomized treatment equivalence is rejected if significance is achieved for both end points at a two-sided alpha level of 0.05 or for one end point at a two-sided alpha level of 0.025.|
1700735|NCT00977665|3126868|Superiority or Other||Hazard Ratio (HR)|1.189|||||2-Sided|95.0|0.646|2.186|||||||
1700736|NCT00977665|3126877|Superiority or Other||Mean Difference (Final Values)|-0.603||||0.6984|2-Sided|95.0|-3.677|2.47||A priori threshold for statistical significance is 0.05.|repeated measures model|Fixed effects: categorical week in trial by treatment interaction, center, and baseline UMSARS score.|||
1700737|NCT00977470|3126910|Equivalence|All enrolled patients will be included in the intent-to-treat efficacy analyses. Based on historical patients with EGFR mutations treated with gefitinib, we expect median progression-free survival on the erlotinib-alone arm to be approximately 9 months. This trial can detect a difference in proportions alive without progression at 9 months from 50% in the erlotinib arm to 77% in the erlotinib plus HCQ arm, using an alpha of 0.15 and power of 85%, using the two-sided Likelihood Ratio test.||||||0.28|||||||Log Rank||||
1700738|NCT00977314|3126933|Superiority or Other||Mean Difference (Final Values)|-2.5|Standard Deviation|1.0|<|0.001|||||||t-test, 2 sided|||The endpoint was the calculated difference between the HINT result for the unaided condition prior to the 30-day trial period (Day 1) and the HINT result using the SoundBite (aided) at the end of the 30-day trial period (Day 30).|
1700742|NCT00977197|3126938|Superiority or Other|||||||0.417|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.|||
1700743|NCT00977197|3126939|Superiority or Other|||||||0.024|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.|||
1700744|NCT00977197|3126940|Superiority or Other|||||||0.02|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.|||
1700745|NCT00977197|3126941|Superiority or Other|||||||0.35||||||Intent to treat analysis, not adjusted for age and gender.|Chi-squared||||
1700746|NCT00977197|3126942|Superiority or Other|||||||0.044|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.|||
1700747|NCT00977197|3126943|Superiority or Other|||||||0.049|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender, rank scale.|||
1700748|NCT00977197|3126944|Superiority or Other|||||||0.389|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender; rank scale.|||
1700749|NCT00977197|3126945|Superiority or Other|||||||0.009|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.|||
1700750|NCT00977197|3126946|Superiority or Other|||||||0.008|||||||ANCOVA|Intent to Treat analysis; adjusted for age and gender.|||
1700751|NCT00977106|3126996|Superiority or Other|||||||0.043|||||||Wilcoxon (Mann-Whitney)|||Change at Week 4|
1700752|NCT00977106|3126996|Superiority or Other|||||||0.137|||||||Wilcoxon (Mann-Whitney)|||Change at Week 1|
1700753|NCT00977106|3126997|Superiority or Other|||||||0.019|||||||Wilcoxon (Mann-Whitney)|||Change at Week 4|
1700754|NCT00977106|3126997|Superiority or Other|||||||0.692|||||||Wilcoxon (Mann-Whitney)|||Change at Week 1|
1700755|NCT00977106|3126999|Superiority or Other|||||||0.434||||||Between placebo and TCZ groups test (Equal Variances) at week 4|t-test, 1 sided||||
1700756|NCT00977106|3127001|Superiority or Other|||||||0.502|||||||Student t-test|Between-group test (equal variances)||Change at Week 4|
1700757|NCT00977106|3127003|Superiority or Other|||||||0.276|||||||Student t-test|Between-group test (unequal variances)||Change at Week 4|
1700758|NCT00977106|3127003|Superiority or Other|||||||0.377||||||Between-group test (equal variances)|Student t-test|||Change at Week 1|
1700759|NCT00977106|3127004|Superiority or Other|||||||0.472|||||||Chi-squared||||
1700760|NCT00977080|3127005|Superiority or Other|||||||1|||||||Fisher Exact||||
1700761|NCT00977080|3127005|Superiority or Other|||||||0.118|||||||Fisher Exact||||
1700762|NCT00977080|3127006|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1700763|NCT00977080|3127006|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1700764|NCT00977080|3127007|Superiority or Other|||||||0.01|||||||Cochran-Mantel-Haenszel||||
1700765|NCT00977080|3127008|Superiority or Other|||||||0.704|||||||Fisher Exact||||
1700766|NCT00977080|3127008|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1700767|NCT00977080|3127009|Superiority or Other|||||||0.239|||||||Fisher Exact||||
1700768|NCT00977080|3127009|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1700769|NCT00977080|3127010|Superiority or Other|||||||0.26||||||No adjustments were made for multiple comparisons between treatment groups since the study was designed to evaluate the primary outcome measure by testing a single hypothesis within each stratum independently.|Fisher Exact|||With a sample size of 49 participants in each treatment group in the oral stratum, a Fisher's exact test with a 0.050 2-sided significance level will have 81% power to detect a 30% difference in the percentage of participants who achieve iPTH between 150 and 300 pg/mL, assuming the cinacalcet percentage is 36% and the paricalcitol percentage is 66%.|
1700770|NCT00977080|3127010|Superiority or Other|||||||0.016||||||No adjustments were made for multiple comparisons between treatment groups since the study was designed to evaluate the primary outcome measure by testing a single hypothesis within each stratum independently.|Fisher Exact|||With a sample size of 49 participants in each treatment group in the IV stratum, a Fisher's exact test with a 0.050 2-sided significance level will have 81% power to detect a 30% difference in the percentage of participants who achieve iPTH between 150 and 300 pg/mL, assuming the cinacalcet percentage is 36% and the paricalcitol percentage is 66%.|
1700771|NCT00976937|3127043|Superiority or Other||Response rate difference|4.6|Standard Error of the Mean|3.28||0.1696|2-Sided|95.0|-1.84|11.0||Cochran-Mantel-Haenszel (CMH) test stratified by randomization strata of screening HbA1c (<8.0 or >=8.0%) and randomization strata of screening BMI (<35 or >=35 kg/m^2) was used.|Cochran-Mantel-Haenszel|||To demonstrate the superiority of lixisenatide over sitagliptin, 150 patients in each arm would provide a power of 90% with a 2-sided test at the 5% significance level, assuming the percentage of patients defined as responders on HbA1c (<7%) and weight (at least 5% loss) is 25% with lixisenatide and 10% with sitagliptin.|
1700772|NCT00976911|3127044|Superiority or Other||Difference in Response Rates|-4.8||||0.7339|2-Sided|95.0|-40.0|30.6|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 30|
1700773|NCT00976911|3127044|Superiority or Other||Difference in Response Rates|9.3||||0.579|2-Sided|95.0|-15.0|34.1|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 24|
1700774|NCT00976911|3127044|Superiority or Other||Difference in Response Rates|3.5||||0.8309|2-Sided|95.0|-14.0|20.9|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus at Week 16/18|
1700775|NCT00976911|3127044|Superiority or Other||Difference in Response Rates|8.8||||0.1859|2-Sided|95.0|-3.8|21.4|||Fisher Exact||95% CI was approximated with Hauck-Anderson continuity correction.|Comparison of responders at baseline versus Week 8/9|
1700776|NCT00976911|3127045|Superiority or Other|||||||0.089||||||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (<3 or 3-6 months).|Peto-Peto-Prentice||||
1700777|NCT00976911|3127045|Superiority or Other||Hazard Ratio (HR)|0.87||||0.2711|2-Sided|95.0|0.678|1.116||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (<3 or 3-6 months).|Log Rank||||
1700778|NCT00976911|3127045|Superiority or Other|||||||0.0715||||||Unstratified analysis|Peto-Peto-Prentice||||
1701678|NCT00966875|3128635|Superiority or Other|||||||0.033||||||P-value is for ACR20-NRI at Week 12.|Fisher Exact||||
1700779|NCT00976911|3127045|Superiority or Other||Hazard Ratio (HR)|0.833||||0.136|2-Sided|95.0|0.655|1.059||Unstratified analysis|Log Rank||||
1700780|NCT00976911|3127046|Superiority or Other||||||<|0.0001|||||||Peto-Peto-Prentice|Stratified analysis:Strata were chemotherapy selected, prior anti-angiogenic therapy, and platinum-free interval.|||
1700781|NCT00976911|3127046|Superiority or Other||||||<|0.0001|||||||Peto-Peto-Prentice|Unstratified analysis|||
1700782|NCT00976911|3127046|Superiority or Other||Hazard Ratio (HR)|0.46|||<|0.0001|2-Sided|95.0|0.366|0.577|||Log Rank|Unstratified analysis|||
1700783|NCT00976911|3127046|Superiority or Other||Hazard Ratio (HR)|0.379|||<|0.0001|2-Sided|95.0|0.296|0.485|||Log Rank||Stratified analysis:Strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (less than [<] 3 or 3-6 months). Cox regression model was used to determine the hazard ratio.||
1700784|NCT00976911|3127048|Superiority or Other|||||||0.0081|||||||Peto-Peto-Prentice||||
1700785|NCT00976911|3127048|Superiority or Other||Hazard Ratio (HR)|0.45||||0.0202|2-Sided|95.0|0.225|0.9||Unstratified analysis|Log Rank||Hazard ratio was estimated by unstratified Cox regression model.||
1700786|NCT00976911|3127049|Superiority or Other|||||||0.0007||||||Stratified analysis: The strata were chemotherapy selected (paclitaxel, PLD, or topotecan), prior anti-angiogenic therapy (yes or no), and platinum-free interval (<3 or 3-6 months).|Cochran-Mantel-Haenszel||||
1700787|NCT00976911|3127049|Superiority or Other|||||||0.001|||||||Pearson's chi-square|unstratified analysis|||
1700788|NCT00976911|3127049|Superiority or Other||Difference in Response Rates|15.7|||||2-Sided|95.0|6.5|24.8|||||||
1700789|NCT00976664|3127150|Superiority or Other|||||||0.0336|||||||Wilcoxon (Mann-Whitney)|Group differences in ODI for low back pain from randomization visit to 12-week visit were assessed using the Wilcoxon rank sums test.|||
1700790|NCT00976664|3127150|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)|Group differences in ODI for low back pain from randomization visit to 6-week visit were assessed using the Wilcoxon rank sums test.|||
1700791|NCT00976664|3127151|Superiority or Other|||||||0.3913|||||||Wilcoxon (Mann-Whitney)|Group differences in VAS for low back pain from randomization visit to 12-week visit were assessed via the Wilcoxon rank sums test.|||
1700792|NCT00976664|3127151|Superiority or Other|||||||0.0007|||||||Wilcoxon (Mann-Whitney)|Group differences in VAS for low back pain from randomization visit to 6-week visit were assessed via the Wilcoxon rank sums test.|||
1700793|NCT00976560|3127268|Superiority or Other||Mean Difference (Net)|-0.6|Standard Deviation|0.99|||2-Sided|95.0|-2.54|1.35|||||Prior distribution of N(-4.1, 6.4009) incorporated into the posterior for the treatment difference at Week 6. The presented Confidence Interval is Highest Probability Density (HPD).||Posterior probability of the treatment difference being greater than 1.6 points in favor of GW856553 7.5mg BID as compared to placebo at Week 6 is 15.46 and for 0 is 72.98 and for 2 is 7.87.
1700794|NCT00976521|3127269|Superiority or Other|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||The primary endpoint of infarct size at 30 days measured by cardiac MRI, was summarized using the median, IQR, minimum and maximum values, in each infusion group, comparing the pooled active infusion arm to the pooled control non-infusion arm with the Wilcoxon rank sum test in the ITT analysis set. Data was only analyzed in subjects completing the cardiac MRI study and for whom the imaging data was received and deemed analyzable by the core laboratory.|
1700795|NCT00976521|3127270|Superiority or Other|||||||0.034|||||||Wilcoxon (Mann-Whitney)|||The primary endpoint of infarct size at 30 days measured by cardiac MRI, was summarized using the median, IQR, minimum and maximum values, in each infusion group, comparing the pooled active infusion arm to the pooled control non-infusion arm with the Wilcoxon rank sum test in the ITT analysis set. Data was only analyzed in subjects completing the cardiac MRI study and for whom the imaging data was received and deemed analyzable by the core laboratory.|
1700796|NCT00976495|3127284|Superiority or Other||Mean Difference (Final Values)|7.31|Standard Error of the Mean|2.8135|||2-Sided|95.0|1.7|12.93|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.||
1700797|NCT00976495|3127284|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|2.7812|||2-Sided|95.0|-5.39|5.71|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.||
1700798|NCT00976495|3127285|Superiority or Other||Mean Difference (Final Values)|0.91|Standard Error of the Mean|2.5474|||2-Sided|95.0|-4.18|5.99|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.||
1700799|NCT00976495|3127285|Superiority or Other||Mean Difference (Final Values)|-4.38|Standard Error of the Mean|2.5072|||2-Sided|95.0|-9.38|0.63|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.||
1700800|NCT00976495|3127286|Superiority or Other||Mean Difference (Final Values)|3.26|Standard Error of the Mean|2.4112|||2-Sided|95.0|-1.55|8.08|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.||
1700801|NCT00976495|3127286|Superiority or Other||Mean Difference (Final Values)|-2.4|Standard Error of the Mean|2.3613|||2-Sided|95.0|-7.11|2.31|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.||
1700802|NCT00976495|3127287|Superiority or Other||Mean Difference (Final Values)|-7.62|Standard Error of the Mean|2.7068|||2-Sided|95.0|-12.87|-2.06|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.||
1700803|NCT00976495|3127287|Superiority or Other||Mean Difference (Final Values)|-8.07|Standard Error of the Mean|2.7177|||2-Sided|95.0|-13.34|-2.49|||||ANCOVA was applied. Given that this was a pilot study designed for exploratory analysis, formal statistical hypothesis testing was not performed.||
1701085|NCT00975195|3127455|Superiority or Other||Mean Difference (Net)|0.14|Standard Error of the Mean|1.48||0.9262|2-Sided|95.0|-2.77|3.04|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701533|NCT00968669|3128375|Superiority or Other|||||||0.628|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward|||
1700804|NCT00976456|3127289|Non-Inferiority or Equivalence|The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 – 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time Point.|Hazard Ratio (HR)|1.091||||0.3869|2-Sided|95.0|0.794|1.499|||Wilcoxon (Mann-Whitney)||||
1700805|NCT00976456|3127290|Non-Inferiority or Equivalence|The estimation was that in the pemetrexed-carboplatin plus bevacizumab Arm the median PFS will be 5.5 months. A median PFS of 4 months (5.5 – 27%) had been regarded non-inferior. Assuming the accrual period of 24 months and the whole study duration of 42 months, 246 patients had to be recruited. According to the fact, that the required statistical power of 80% will be reached by occurrence of altogether 227 events, the final analysis was done at this time point.|Hazard Ratio (HR)|1.29||||0.0583|2-Sided|95.0|0.989|1.682|||Wilcoxon (Mann-Whitney)||||
1700806|NCT00976391|3127303|Non-Inferiority or Equivalence|P-value from a one-sided t-test to test whether the difference of least square means (albiglutide – preprandial lispro insulin) is less than or equal to the pre-specified non-inferiority margin of 0.4%|Mean Difference (Net)|-0.16|||<|0.0001|2-Sided|95.0|-0.32|0.0|||t-test, 1 sided||||
1700807|NCT00975923|3127326|Superiority or Other||percentages|10.0|||<|5|2-Sided|95.0|||||Chi-squared||Power calculation used alpha = .05 and group size = 30.The estimated effect was a 50% decrease in infection rates for the Collaborative Group and from 10% to 15% decrease in the Tool Kit group.Power ranged from 82%-91% for testing group differences.|It was hypothesized that the Collaborative group would engage in more processes and tools than the Tool Kit group. Power was based on infection rates.|
1700808|NCT00975923|3127327|Superiority or Other||infection rates per device days|2.0|Standard Error of the Mean|0.05|<|0.05|2-Sided|95.0|1.0|3.0||p-value and confidence intervals|Regression, Linear|||Infection rates were analyzed using hierarchical negative binomial regression models to model infection rate changes over time and account for clustering of ICUs within hospitals and adjusting for baseline covariates. Power was calculated a priori with a 1-tailed alpha of 0.05 and group size of 30; a 50% decrease in infection rates in the Collaborative group and 15% for the Tool Kit group, yielding power ranging from 82% to 91% for testing group differences.|
1700809|NCT00975585|3127400|Superiority or Other||Mean Difference (Final Values)|-0.411|Standard Error of the Mean|0.124|||2-Sided|98.2|-0.411|-0.117|||||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by stie interaction as fixed effects, subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have less frequency of dryness than lotrafilcon B contact lenes after two weeks of wear.|
1700810|NCT00975585|3127401|Non-Inferiority or Equivalence|Margin = 0.5|Mean Difference (Final Values)|-0.068|Standard Error of the Mean|0.032|||2-Sided|98.2|-0.068|0.008|||||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior in bulbar redness to lotrafilcon B contact lenses after two weeks of wear.|
1700811|NCT00975585|3127402|Non-Inferiority or Equivalence|Margin = 0.5|Mean Difference (Final Values)|-0.123|Standard Error of the Mean|0.03|||2-Sided|98.2|-0.123|-0.051|||||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior in limbal redness 5 to lotrafilcon B contact lenses after two weeks of wear.|
1700812|NCT00975585|3127403|Superiority or Other||Mean Difference (Final Values)|0.098|Standard Error of the Mean|0.141|||2-Sided|97.46|-0.218|0.098|||||The mean difference is lotrafilcon B at 2 weeks minus lotrafilcon B at 4 weeks. Analysis adjusted for duration of wear, stie, duration of wear by site interaction as fixed effects, subject as random effects.|The alternative hypothesis is that lotrafilcon B contact lenses have a lower rating of overall comfort after 4 weeks of wear compared to after 2 weeks of wear.|
1700813|NCT00975585|3127404|Superiority or Other||Mean Difference (Final Values)|0.402|Standard Error of the Mean|0.127|||2-Sided|97.46|0.117|0.402|||||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have a higher rating of overall comfort than lotrafilcon B after two weeks of wear.|
1700814|NCT00975585|3127405|Non-Inferiority or Equivalence|Margin = 0.25|Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.005|||2-Sided|97.46|-0.021|-0.01|||||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses are non-inferior (less than or equal to)in visual acuity to lotrafilcon B contact lenses after two weeks of wear.|
1700815|NCT00975585|3127406|Non-Inferiority or Equivalence|Margin = 0.5|Mean Difference (Final Values)|-0.014|Standard Error of the Mean|0.02|||2-Sided|97.46|-0.058|0.031|||||The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis is adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.|The alternative hypothesis is that senofilcon A contact lenses have non-inferior (less than or equal to) average corneal staining than lotrafilcon B after two weeks of wear.|
1700816|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|2.5366|||<|0.0001|2-Sided|95.0|1.7578|3.3155|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700817|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|3.0576|||<|0.0001|2-Sided|95.0|2.2858|3.8294|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700818|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|2.7545|||<|0.0001|2-Sided|95.0|1.9912|3.5179|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700819|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|1.6645|||<|0.0001|2-Sided|95.0|0.8786|2.4503|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700820|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|2.1854|||<|0.0001|2-Sided|95.0|1.407|2.9638|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700821|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|1.8824|||<|0.0001|2-Sided|95.0|1.1094|2.6553|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700822|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|-0.497|||<|0.2152|2-Sided|95.0|-1.286|0.2921|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700823|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|0.024|||<|0.9519|2-Sided|95.0|-0.7608|0.8087|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700824|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|-0.2791|||<|0.4804|2-Sided|95.0|-1.0586|0.5004|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700825|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|-3.0336|||<|0.0001|2-Sided|95.0|-3.8085|-2.2587|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700826|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|-2.1614|||<|0.0001|2-Sided|95.0|-2.9373|-1.3856|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700827|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|-0.8818|||<|0.0011|2-Sided|95.0|-1.4042|-0.3594|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700828|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|-0.7238|||<|0.0065|2-Sided|95.0|-1.2418|-0.2059|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700829|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|-0.6351|||<|0.0153|2-Sided|95.0|-1.1466|-0.1236|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700830|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|-0.4011|||<|0.1355|2-Sided|95.0|-0.9291|0.127|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701534|NCT00968669|3128375|Superiority or Other|||||||0.828|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward|||
1700831|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|-0.2431|||<|0.3594|2-Sided|95.0|-0.7658|0.2796|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700832|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|-0.1544|||<|0.5576|2-Sided|95.0|-0.6737|0.3649|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700833|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|-0.0374|||<|0.8892|2-Sided|95.0|-0.5666|0.4919|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700834|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|0.1206|||<|0.6517|2-Sided|95.0|-0.4064|0.6476|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700835|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|0.2093|||<|0.4305|2-Sided|95.0|-0.3141|0.7327|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700836|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|0.8444|||<|0.0017|2-Sided|95.0|0.3238|1.365|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700837|NCT00975481|3127412|Superiority or Other||Mean Difference (Final Values)|0.3637|||<|0.1691|2-Sided|95.0|-0.1566|0.884|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700838|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-31.6728||||0.1386|2-Sided|95.0|-74.5352|11.1895|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700839|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-32.0907||||0.0827|2-Sided|95.0|-68.7519|4.5704|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700840|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-35.2566||||0.0832|2-Sided|95.0|-75.608|5.0948|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700841|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|10.4573||||0.5863|2-Sided|95.0|-29.0355|49.9502|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700842|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|10.0394||||0.6187|2-Sided|95.0|-31.4818|51.5606|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700843|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|6.8736||||0.6998|2-Sided|95.0|-29.8691|43.6163|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701679|NCT00966875|3128635|Superiority or Other|||||||0.058||||||P-value is for ACR20-NRI at Week 12.|Fisher Exact||||
1700844|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|11.1248||||0.5899|2-Sided|95.0|-31.3098|53.5595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700845|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|10.7069||||0.5492|2-Sided|95.0|-26.0358|47.4496|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700846|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|7.5411||||0.7068|2-Sided|95.0|-33.785|48.8672|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700847|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|42.7977||||0.0246|2-Sided|95.0|6.1059|79.4894|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700848|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|0.6675||||0.9728|2-Sided|95.0|-39.708|41.043|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For pseudoephedrine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700849|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-23.6378||||0.0003|2-Sided|95.0|-36.2802|-10.9954|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700850|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-32.4315|||<|0.0001|2-Sided|95.0|-44.925|-19.938|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700851|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-26.4672|||<|0.0001|2-Sided|95.0|-38.8298|-14.1046|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700852|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-19.1168|||<|0.0036|2-Sided|95.0|-31.8907|-6.3428|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700853|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-27.9105|||<|0.0001|2-Sided|95.0|-40.564|-15.257|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700854|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-21.9461|||<|0.0007|2-Sided|95.0|-34.5327|-9.3596|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700855|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|5.4722|||<|0.3999|2-Sided|95.0|-7.335|18.2795|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700856|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-3.3215|||<|0.6067|2-Sided|95.0|-16.0415|9.3985|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701680|NCT00966875|3128635|Superiority or Other|||||||0.07||||||P-value is for ACR20-NRI at Week 12.|Fisher Exact||||
1700857|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|2.6428|||<|0.6809|2-Sided|95.0|-10.0309|15.3165|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700858|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|29.11|||<|0.0001|2-Sided|95.0|16.4903|41.7298|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700859|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|24.589|||<|0.0002|2-Sided|95.0|12.0126|37.1654|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For THC, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700860|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-20.4385|||<|0.0222|2-Sided|95.0|-37.8861|-2.991|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700861|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-24.1835|||<|0.0069|2-Sided|95.0|-41.5832|-6.7838|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700862|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-32.4655|||<|0.0002|2-Sided|95.0|-49.2278|-15.7032|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700863|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-16.2261|||<|0.0759|2-Sided|95.0|-34.1785|1.7264|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700864|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-19.9711|||<|0.0299|2-Sided|95.0|-37.9541|-1.988|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700865|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-28.2531|||<|0.0019|2-Sided|95.0|-45.802|-10.7042|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700866|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|7.2936|||<|0.4177|2-Sided|95.0|-10.4975|25.0847|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700867|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|3.5486|||<|0.6945|2-Sided|95.0|-14.3397|21.437|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700868|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-4.7334|||<|0.5935|2-Sided|95.0|-22.2807|12.814|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700869|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|27.7321|||<|0.0021|2-Sided|95.0|10.3632|45.1011|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700870|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|23.5197|||<|0.0102|2-Sided|95.0|5.7096|41.3298|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For codeine/morphine, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700871|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-40.8794|||<|0.0001|2-Sided|95.0|-60.4726|-21.2862|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700872|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-51.2265|||<|0.0001|2-Sided|95.0|-70.8131|-31.6399|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700873|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-59.4297|||<|0.0001|2-Sided|95.0|-78.5162|-40.3433|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700874|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-36.6534|||<|0.0004|2-Sided|95.0|-56.7246|-16.5822|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700875|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-47.0005|||<|0.0001|2-Sided|95.0|-67.002|-26.9989|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700876|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-55.2037|||<|0.0001|2-Sided|95.0|-74.8113|-35.5961|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700877|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|0.792|||<|0.9375|2-Sided|95.0|-19.1777|20.7616|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700878|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-9.5551|||<|0.3458|2-Sided|95.0|-29.5573|10.4471|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700879|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-17.7583|||<|0.0744|2-Sided|95.0|-37.2956|1.7789|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700880|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|41.6714|||<|0.0001|2-Sided|95.0|22.2888|61.054|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700881|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|37.4454|||<|0.0003|2-Sided|95.0|17.7051|57.1857|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For benzodiazepines, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700882|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|51.6772|||<|0.0001|2-Sided|95.0|35.866|67.4884|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700883|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|53.9622|||<|0.0001|2-Sided|95.0|38.3293|69.5952|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700884|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|57.5565|||<|0.0001|2-Sided|95.0|42.0679|73.0451|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700885|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|46.5395|||<|0.0001|2-Sided|95.0|30.5968|62.4823|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700886|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|48.8246|||<|0.0001|2-Sided|95.0|33.0228|64.6264|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700887|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|52.4189|||<|0.0001|2-Sided|95.0|36.7157|68.1221|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700888|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|0.1573|||<|0.9846|2-Sided|95.0|-15.8609|16.1754|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700889|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|2.4423|||<|0.762|2-Sided|95.0|-13.4599|18.3446|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700890|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|6.0366|||<|0.4524|2-Sided|95.0|-9.7924|21.8657|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700891|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-51.5199|||<|0.0001|2-Sided|95.0|-67.2633|-35.7765|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700892|NCT00975481|3127413|Superiority or Other||Mean Difference (Final Values)|-46.3823|||<|0.0001|2-Sided|95.0|-62.1244|-30.6401|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For placebo, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI was obtained from the model.|
1700893|NCT00975481|3127414|Superiority or Other||Mean Difference (Final Values)|-44.3241|||<|0.0001|2-Sided|95.0|-57.5825|-31.0656|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700894|NCT00975481|3127414|Superiority or Other||Mean Difference (Final Values)|-55.2851|||<|0.0001|2-Sided|95.0|-68.3904|-42.1798|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700895|NCT00975481|3127414|Superiority or Other||Mean Difference (Final Values)|-51.421|||<|0.0001|2-Sided|95.0|-64.3974|-38.4445|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701535|NCT00968669|3128375|Superiority or Other|||||||0.435|||||||ANOVA|Missing mean ACQ scores at Day 92 was imputed by last observation carried forward|||
1700896|NCT00975481|3127414|Superiority or Other||Mean Difference (Final Values)|-40.2062|||<|0.0001|2-Sided|95.0|-53.589|-26.8234|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700897|NCT00975481|3127414|Superiority or Other||Mean Difference (Final Values)|-51.1672|||<|0.0001|2-Sided|95.0|-64.4276|-37.9069|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700898|NCT00975481|3127414|Superiority or Other||Mean Difference (Final Values)|-47.3031|||<|0.0001|2-Sided|95.0|-60.4869|-34.1193|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700899|NCT00975481|3127414|Superiority or Other||Mean Difference (Final Values)|6.3982|||<|0.3482|2-Sided|95.0|-7.0337|19.8301|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700900|NCT00975481|3127414|Superiority or Other||Mean Difference (Final Values)|-4.5629|||<|0.5002|2-Sided|95.0|-17.9006|8.7749|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700901|NCT00975481|3127414|Superiority or Other||Mean Difference (Final Values)|-0.6987|||<|0.9174|2-Sided|95.0|-13.9815|12.584|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700902|NCT00975481|3127414|Superiority or Other||Mean Difference (Final Values)|50.7222|||<|0.0001|2-Sided|95.0|37.5038|63.9407|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700903|NCT00975481|3127414|Superiority or Other||Mean Difference (Final Values)|46.6044|||<|0.0001|2-Sided|95.0|33.4091|59.7996|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700904|NCT00975481|3127415|Superiority or Other||Mean Difference (Final Values)|29.397|||<|0.0001|2-Sided|95.0|22.8946|35.8994|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700905|NCT00975481|3127415|Superiority or Other||Mean Difference (Final Values)|28.9963|||<|0.0001|2-Sided|95.0|22.5734|35.4192|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700906|NCT00975481|3127415|Superiority or Other||Mean Difference (Final Values)|34.469|||<|0.0001|2-Sided|95.0|28.1136|40.8244|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700907|NCT00975481|3127415|Superiority or Other||Mean Difference (Final Values)|23.4452|||<|0.0001|2-Sided|95.0|16.8772|30.0131|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700908|NCT00975481|3127415|Superiority or Other||Mean Difference (Final Values)|23.0445|||<|0.0001|2-Sided|95.0|16.5383|29.5506|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701139|NCT00973973|3127775|Superiority||LS Mean Difference|-0.27|Standard Error of the Mean|0.127||0.036|2-Sided|95.0|-0.52|-0.02|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change form baseline at week 4|
1700909|NCT00975481|3127415|Superiority or Other||Mean Difference (Final Values)|28.5172|||<|0.0001|2-Sided|95.0|22.0454|34.989|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700910|NCT00975481|3127415|Superiority or Other||Mean Difference (Final Values)|-3.1754|||<|0.344|2-Sided|95.0|-9.7855|3.4347|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700911|NCT00975481|3127415|Superiority or Other||Mean Difference (Final Values)|-3.5761|||<|0.2848|2-Sided|95.0|-10.159|3.0068|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700912|NCT00975481|3127415|Superiority or Other||Mean Difference (Final Values)|1.8966|||<|0.5685|2-Sided|95.0|-4.6607|8.454|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700913|NCT00975481|3127415|Superiority or Other||Mean Difference (Final Values)|-32.5724|||<|0.0001|2-Sided|95.0|-39.1073|-26.0375|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700914|NCT00975481|3127415|Superiority or Other||Mean Difference (Final Values)|-26.6205|||<|0.0001|2-Sided|95.0|-33.1192|-20.1219|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700915|NCT00975481|3127416|Superiority or Other||Mean Difference (Final Values)|-5.9611|||<|0.0001|2-Sided|95.0|-7.1812|-4.741|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700916|NCT00975481|3127416|Superiority or Other||Mean Difference (Final Values)|-6.0493|||<|0.0001|2-Sided|95.0|-7.2568|-4.8419|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700917|NCT00975481|3127416|Superiority or Other||Mean Difference (Final Values)|-6.2437|||<|0.0001|2-Sided|95.0|-7.4397|-5.0477|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700918|NCT00975481|3127416|Superiority or Other||Mean Difference (Final Values)|-4.3571|||<|0.0001|2-Sided|95.0|-5.5887|-3.1255|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700919|NCT00975481|3127416|Superiority or Other||Mean Difference (Final Values)|-4.4453|||<|0.0001|2-Sided|95.0|-5.6662|-3.2244|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700920|NCT00975481|3127416|Superiority or Other||Mean Difference (Final Values)|-4.6397|||<|0.0001|2-Sided|95.0|-5.8537|-3.4257|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700921|NCT00975481|3127416|Superiority or Other||Mean Difference (Final Values)|0.9372|||<|0.1373|2-Sided|95.0|-0.3024|2.1767|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701140|NCT00973973|3127777|Superiority||LS Mean Difference|-0.33|Standard Error of the Mean|0.1||0.0011|2-Sided|95.0|-0.53|-0.14|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8|
1700922|NCT00975481|3127416|Superiority or Other||Mean Difference (Final Values)|0.8489|||<|0.1738|2-Sided|95.0|-0.3784|2.0763|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700923|NCT00975481|3127416|Superiority or Other||Mean Difference (Final Values)|0.6545|||<|0.2917|2-Sided|95.0|-0.5676|1.8767|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700924|NCT00975481|3127416|Superiority or Other||Mean Difference (Final Values)|6.8983|||<|0.0001|2-Sided|95.0|5.6799|8.1167|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700925|NCT00975481|3127416|Superiority or Other||Mean Difference (Final Values)|5.2943|||<|0.0001|2-Sided|95.0|4.0783|6.5102|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700926|NCT00975481|3127417|Superiority or Other||Mean Difference (Final Values)|-3.465|||<|0.0001|2-Sided|95.0|-4.1583|-2.7717|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700927|NCT00975481|3127417|Superiority or Other||Mean Difference (Final Values)|-3.1802|||<|0.0001|2-Sided|95.0|-3.8656|-2.4947|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700928|NCT00975481|3127417|Superiority or Other||Mean Difference (Final Values)|-3.1592|||<|0.0001|2-Sided|95.0|-3.838|-2.4804|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700929|NCT00975481|3127417|Superiority or Other||Mean Difference (Final Values)|-1.2175|||<|0.0008|2-Sided|95.0|-1.9171|-0.5178|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700930|NCT00975481|3127417|Superiority or Other||Mean Difference (Final Values)|-0.9326|||<|0.0088|2-Sided|95.0|-1.6269|-0.2384|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700931|NCT00975481|3127417|Superiority or Other||Mean Difference (Final Values)|-0.9117|||<|0.0099|2-Sided|95.0|-1.6013|-0.222|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700932|NCT00975481|3127417|Superiority or Other||Mean Difference (Final Values)|0.036|||<|0.9197|2-Sided|95.0|-0.6686|0.7406|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700933|NCT00975481|3127417|Superiority or Other||Mean Difference (Final Values)|0.3208|||<|0.3678|2-Sided|95.0|-0.3808|1.0225|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700934|NCT00975481|3127417|Superiority or Other||Mean Difference (Final Values)|0.3418|||<|0.3347|2-Sided|95.0|-0.3559|1.0396|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701141|NCT00973973|3127777|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.082||0.0089|2-Sided|95.0|-0.38|-0.06|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4|
1700935|NCT00975481|3127417|Superiority or Other||Mean Difference (Final Values)|3.501|||<|0.0001|2-Sided|95.0|2.8073|4.1948|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700936|NCT00975481|3127417|Superiority or Other||Mean Difference (Final Values)|1.2535|||<|0.0005|2-Sided|95.0|0.5623|1.9446|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700937|NCT00975481|3127418|Superiority or Other||Mean Difference (Final Values)|-24.5693|||<|0.0001|2-Sided|95.0|-34.7614|-14.3772|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700938|NCT00975481|3127418|Superiority or Other||Mean Difference (Final Values)|-27.2502|||<|0.0001|2-Sided|95.0|-37.3224|-17.178|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700939|NCT00975481|3127418|Superiority or Other||Mean Difference (Final Values)|-29.1396|||<|0.0001|2-Sided|95.0|-39.1071|-19.1721|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700940|NCT00975481|3127418|Superiority or Other||Mean Difference (Final Values)|-13.0325|||<|0.0135|2-Sided|95.0|-23.3295|-2.7355|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700941|NCT00975481|3127418|Superiority or Other||Mean Difference (Final Values)|-15.7134|||<|0.0028|2-Sided|95.0|-25.9136|-5.5132|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700942|NCT00975481|3127418|Superiority or Other||Mean Difference (Final Values)|-17.6028|||<|0.0008|2-Sided|95.0|-27.7485|-7.4572|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700943|NCT00975481|3127418|Superiority or Other||Mean Difference (Final Values)|3.4279|||<|0.5128|2-Sided|95.0|-6.8972|13.7529|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700944|NCT00975481|3127418|Superiority or Other||Mean Difference (Final Values)|0.747|||<|0.8858|2-Sided|95.0|-9.5075|11.0015|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700945|NCT00975481|3127418|Superiority or Other||Mean Difference (Final Values)|-1.1425|||<|0.8254|2-Sided|95.0|-11.3591|9.0742|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700946|NCT00975481|3127418|Superiority or Other||Mean Difference (Final Values)|27.9971|||<|0.0001|2-Sided|95.0|17.8247|38.1696|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700947|NCT00975481|3127418|Superiority or Other||Mean Difference (Final Values)|16.4604|||<|0.0016|2-Sided|95.0|6.321|26.5998|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701142|NCT00973973|3127779|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.101||0.0066|2-Sided|95.0|-0.48|-0.08|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8|
1700948|NCT00975481|3127419|Superiority or Other||Mean Difference (Final Values)|-52.3018|||<|0.0001|2-Sided|95.0|-64.5427|-40.0609|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700949|NCT00975481|3127419|Superiority or Other||Mean Difference (Final Values)|-58.6906|||<|0.0001|2-Sided|95.0|-70.7965|-46.5847|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700950|NCT00975481|3127419|Superiority or Other||Mean Difference (Final Values)|-62.5926|||<|0.0001|2-Sided|95.0|-74.5881|-50.5971|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700951|NCT00975481|3127419|Superiority or Other||Mean Difference (Final Values)|-41.6455|||<|0.0001|2-Sided|95.0|-53.9964|-29.2946|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700952|NCT00975481|3127419|Superiority or Other||Mean Difference (Final Values)|-48.0343|||<|0.0001|2-Sided|95.0|-60.2801|-35.7885|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700953|NCT00975481|3127419|Superiority or Other||Mean Difference (Final Values)|-51.9363|||<|0.0001|2-Sided|95.0|-64.1108|-39.7618|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700954|NCT00975481|3127419|Superiority or Other||Mean Difference (Final Values)|5.1995|||<|0.4086|2-Sided|95.0|-7.1963|17.5954|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700955|NCT00975481|3127419|Superiority or Other||Mean Difference (Final Values)|-1.1893|||<|0.8488|2-Sided|95.0|-13.4954|11.1168|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700956|NCT00975481|3127419|Superiority or Other||Mean Difference (Final Values)|-5.0913|||<|0.4129|2-Sided|95.0|-17.3421|7.1595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700957|NCT00975481|3127419|Superiority or Other||Mean Difference (Final Values)|57.5013|||<|0.0001|2-Sided|95.0|45.3036|69.6991|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700958|NCT00975481|3127419|Superiority or Other||Mean Difference (Final Values)|46.845|||<|0.0001|2-Sided|95.0|34.6464|59.0436|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700959|NCT00975481|3127420|Superiority or Other||Mean Difference (Final Values)|-45.4546|||<|0.0001|2-Sided|95.0|-57.5459|-33.3633|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700960|NCT00975481|3127420|Superiority or Other||Mean Difference (Final Values)|-53.2403|||<|0.0001|2-Sided|95.0|-65.1923|-41.2882|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701143|NCT00973973|3127779|Superiority||LS Mean Difference|-0.21|Standard Error of the Mean|0.086||0.0163|2-Sided|95.0|-0.38|-0.04|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4|
1700961|NCT00975481|3127420|Superiority or Other||Mean Difference (Final Values)|-50.4567|||<|0.0001|2-Sided|95.0|-62.2925|-38.621|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700962|NCT00975481|3127420|Superiority or Other||Mean Difference (Final Values)|-41.6573|||<|0.0001|2-Sided|95.0|-53.86|-29.4546|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700963|NCT00975481|3127420|Superiority or Other||Mean Difference (Final Values)|-49.443|||<|0.0001|2-Sided|95.0|-61.5346|-37.3514|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700964|NCT00975481|3127420|Superiority or Other||Mean Difference (Final Values)|-46.6594|||<|0.0001|2-Sided|95.0|-58.6804|-34.6385|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700965|NCT00975481|3127420|Superiority or Other||Mean Difference (Final Values)|4.4225|||<|0.4768|2-Sided|95.0|-7.827|16.6719|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700966|NCT00975481|3127420|Superiority or Other||Mean Difference (Final Values)|-3.3632|||<|0.5857|2-Sided|95.0|-15.5264|8.8|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700967|NCT00975481|3127420|Superiority or Other||Mean Difference (Final Values)|-0.5797|||<|0.9248|2-Sided|95.0|-12.6918|11.5325|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700968|NCT00975481|3127420|Superiority or Other||Mean Difference (Final Values)|49.8771|||<|0.0001|2-Sided|95.0|37.8247|61.9295|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700969|NCT00975481|3127420|Superiority or Other||Mean Difference (Final Values)|46.0798|||<|0.0001|2-Sided|95.0|34.0453|58.1142|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700970|NCT00975481|3127421|Superiority or Other||Mean Difference (Final Values)|-4.576|||<|0.0001|2-Sided|95.0|-5.8438|-3.3081|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700971|NCT00975481|3127421|Superiority or Other||Mean Difference (Final Values)|-4.4495|||<|0.0001|2-Sided|95.0|-5.7031|-3.1959|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700972|NCT00975481|3127421|Superiority or Other||Mean Difference (Final Values)|-4.5228|||<|0.0001|2-Sided|95.0|-5.7651|-3.2805|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700973|NCT00975481|3127421|Superiority or Other||Mean Difference (Final Values)|-3.0688|||<|0.0001|2-Sided|95.0|-4.3484|-1.7891|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701370|NCT00972504|3127965|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|0.27|||2-Sided|95.0|-1.8|-0.8|||||||
1705473|NCT00911508|3136675|Superiority||Cox Proportional Hazard|0.76|||||2-Sided|95.0|0.33|1.72|||||||
1700974|NCT00975481|3127421|Superiority or Other||Mean Difference (Final Values)|-2.9423|||<|0.0001|2-Sided|95.0|-4.2101|-1.6745|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700975|NCT00975481|3127421|Superiority or Other||Mean Difference (Final Values)|-3.0156|||<|0.0001|2-Sided|95.0|-4.2754|-1.7558|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700976|NCT00975481|3127421|Superiority or Other||Mean Difference (Final Values)|0.0946|||<|0.8844|2-Sided|95.0|-1.1898|1.3791|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700977|NCT00975481|3127421|Superiority or Other||Mean Difference (Final Values)|0.2211|||<|0.7324|2-Sided|95.0|-1.054|1.4963|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700978|NCT00975481|3127421|Superiority or Other||Mean Difference (Final Values)|0.1478|||<|0.8184|2-Sided|95.0|-1.1217|1.4173|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700979|NCT00975481|3127421|Superiority or Other||Mean Difference (Final Values)|4.6706|||<|0.0001|2-Sided|95.0|3.4066|5.9346|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700980|NCT00975481|3127421|Superiority or Other||Mean Difference (Final Values)|3.1634|||<|0.0001|2-Sided|95.0|1.9014|4.4254|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700981|NCT00975481|3127422|Superiority or Other||Mean Difference (Final Values)|-20.0609|||<|0.0001|2-Sided|95.0|-25.0872|-15.0345|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700982|NCT00975481|3127422|Superiority or Other||Mean Difference (Final Values)|-21.4555|||<|0.0001|2-Sided|95.0|-26.423|-16.488|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700983|NCT00975481|3127422|Superiority or Other||Mean Difference (Final Values)|-19.5195|||<|0.0001|2-Sided|95.0|-24.4361|-14.603|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700984|NCT00975481|3127422|Superiority or Other||Mean Difference (Final Values)|-14.8053|||<|0.0001|2-Sided|95.0|-19.8822|-9.7283|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700985|NCT00975481|3127422|Superiority or Other||Mean Difference (Final Values)|-16.1999|||<|0.0001|2-Sided|95.0|-21.2294|-11.1704|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700986|NCT00975481|3127422|Superiority or Other||Mean Difference (Final Values)|-14.264|||<|0.0001|2-Sided|95.0|-19.266|-9.2619|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701371|NCT00972504|3127965|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.27|||2-Sided|95.0|-1.2|-0.1|||||||
1705474|NCT00911508|3136676|Superiority||Cox Proportional Hazard|0.87|||||2-Sided|95.0|0.51|1.51|||||||
1700987|NCT00975481|3127422|Superiority or Other||Mean Difference (Final Values)|-0.3325|||<|0.8975|2-Sided|95.0|-5.4245|4.7595|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700988|NCT00975481|3127422|Superiority or Other||Mean Difference (Final Values)|-1.7271|||<|0.5009|2-Sided|95.0|-6.7841|3.3299|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700989|NCT00975481|3127422|Superiority or Other||Mean Difference (Final Values)|0.2088|||<|0.9348|2-Sided|95.0|-4.8289|5.2466|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700990|NCT00975481|3127422|Superiority or Other||Mean Difference (Final Values)|19.7284|||<|0.0001|2-Sided|95.0|14.7131|24.7437|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700991|NCT00975481|3127422|Superiority or Other||Mean Difference (Final Values)|14.4728|||<|0.0001|2-Sided|95.0|9.4718|19.4737|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700992|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|10.0542|||<|0.0001|2-Sided|95.0|5.494|14.6144|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700993|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|9.5432|||<|0.0001|2-Sided|95.0|5.032|14.0544|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700994|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|10.4724|||<|0.0001|2-Sided|95.0|5.9992|14.9456|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700995|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|2.3476|||<|0.314|2-Sided|95.0|-2.2429|6.9381|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700996|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|1.8366|||<|0.4267|2-Sided|95.0|-2.7158|6.389|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700997|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|2.7658|||<|0.2287|2-Sided|95.0|-1.7552|7.2868|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700998|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|0.9175|||<|0.6954|2-Sided|95.0|-3.7022|5.5373|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1700999|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|0.4065|||<|0.8612|2-Sided|95.0|-4.1779|4.9909|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701536|NCT00968253|3128447|Superiority or Other||Maximum tolerated dose|5.0|||||2-Sided||||||||Maximum tolerated dose (MTD) of Everolimus measured in mg/day in combination with HyperCVAD||
1701000|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|1.3357|||<|0.5637|2-Sided|95.0|-3.2244|5.8958|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701001|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|-9.1367|||<|0.0001|2-Sided|95.0|-13.6684|-4.605|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701002|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|-1.4301|||<|0.5349|2-Sided|95.0|-5.9725|3.1123|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701003|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|-24.2994|||<|0.0001|2-Sided|95.0|-29.6361|-18.9626|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701004|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|-25.4114|||<|0.0001|2-Sided|95.0|-30.6869|-20.1358|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701005|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|-23.9313|||<|0.0001|2-Sided|95.0|-29.1559|-18.7066|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701006|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|-23.1916|||<|0.0001|2-Sided|95.0|-28.5768|-17.8064|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701007|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|-24.3036|||<|0.0001|2-Sided|95.0|-29.64|-18.9672|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701008|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|-22.8235|||<|0.0001|2-Sided|95.0|-28.1283|-17.5187|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701009|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|1.6863|||<|0.5387|2-Sided|95.0|-3.7203|7.0929|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701010|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|0.5743|||<|0.8329|2-Sided|95.0|-4.7941|5.9427|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701011|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|2.0544|||<|0.4489|2-Sided|95.0|-3.2911|7.3998|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701012|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|25.9857|||<|0.0001|2-Sided|95.0|20.667|31.3043|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701537|NCT00968227|3128449|Superiority|Paired t-test||||||0.001|||||||t-test, 2 sided||||
1701013|NCT00975481|3127423|Superiority or Other||Mean Difference (Final Values)|24.8779|||<|0.0001|2-Sided|95.0|19.5658|30.1899|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701014|NCT00975481|3127424|Superiority or Other||Mean Difference (Final Values)|-31.1439|||<|0.0001|2-Sided|95.0|-41.4754|-20.8124|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701015|NCT00975481|3127424|Superiority or Other||Mean Difference (Final Values)|-33.5552|||<|0.0001|2-Sided|95.0|-43.7675|-23.3429|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701016|NCT00975481|3127424|Superiority or Other||Mean Difference (Final Values)|-35.8134|||<|0.0001|2-Sided|95.0|-45.9257|-25.7012|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701017|NCT00975481|3127424|Superiority or Other||Mean Difference (Final Values)|-25.7374|||<|0.0001|2-Sided|95.0|-36.1651|-15.3096|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701018|NCT00975481|3127424|Superiority or Other||Mean Difference (Final Values)|-28.1487|||<|0.0001|2-Sided|95.0|-38.4812|-17.8161|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701019|NCT00975481|3127424|Superiority or Other||Mean Difference (Final Values)|-30.4069|||<|0.0001|2-Sided|95.0|-40.6795|-20.1343|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701020|NCT00975481|3127424|Superiority or Other||Mean Difference (Final Values)|-1.7283|||<|0.7447|2-Sided|95.0|-12.195|8.7383|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701021|NCT00975481|3127424|Superiority or Other||Mean Difference (Final Values)|-4.1396|||<|0.4326|2-Sided|95.0|-14.5328|6.2526|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701022|NCT00975481|3127424|Superiority or Other||Mean Difference (Final Values)|-6.3979|||<|0.2239|2-Sided|95.0|-16.7479|3.9521|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701023|NCT00975481|3127424|Superiority or Other||Mean Difference (Final Values)|29.4156|||<|0.0001|2-Sided|95.0|19.116|39.7151|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701024|NCT00975481|3127424|Superiority or Other||Mean Difference (Final Values)|24.009|||<|0.0001|2-Sided|95.0|13.7265|34.2916|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||Mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701025|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-11.7103||||0.0008|2-Sided|95.0|-18.5055|-4.9151|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701372|NCT00972322|3127980|Superiority or Other||Mean Difference (Final Values)|-15.34|Standard Error of the Mean|8.7||0.083|2-Sided|90.0|-29.87|-0.82|||Least Squares Means Difference||Placebo - MK-8245 on Day 28||
1701026|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-10.9356||||0.0016|2-Sided|95.0|-17.6548|-4.2165|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701027|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-14.2643|||<|0.0001|2-Sided|95.0|-20.9226|-7.606|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701028|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-13.7223|||<|0.0001|2-Sided|95.0|-20.572|-6.8727|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701029|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-12.9477|||<|0.0002|2-Sided|95.0|-19.7374|-6.158|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701030|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-16.2763|||<|0.0001|2-Sided|95.0|-23.0228|-9.5229|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701031|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-1.6335|||<|0.6399|2-Sided|95.0|-8.5177|5.2506|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701032|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-0.8589|||<|0.8042|2-Sided|95.0|-7.6927|5.975|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701033|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-4.1875|||<|0.2257|2-Sided|95.0|-10.989|2.6139|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701034|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|10.0768|||<|0.0038|2-Sided|95.0|3.3132|16.8403|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701035|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|12.0888|||<|0.0006|2-Sided|95.0|5.3225|18.8551|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701036|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-19.7524|||<|0.0001|2-Sided|95.0|-25.8485|-13.6563|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701037|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-22.7673|||<|0.0001|2-Sided|95.0|-28.7925|-16.7422||Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.|Mixed Models Analysis|||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701038|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-21.4554|||<|0.0001|2-Sided|95.0|-27.4199|-15.4908|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701622|NCT00966875|3128623|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701039|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-16.548|||<|0.0001|2-Sided|95.0|-22.7036|-10.3923|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701040|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-19.5629|||<|0.0001|2-Sided|95.0|-25.6616|-13.4642|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701041|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-18.2509|||<|0.0001|2-Sided|95.0|-24.3155|-12.1864|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701042|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|0.0908|||<|0.9769|2-Sided|95.0|-6.085|6.2667|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701043|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-2.9241|||<|0.3477|2-Sided|95.0|-9.0571|3.2089|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701044|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|-1.6121|||<|0.6029|2-Sided|95.0|-7.7209|4.4967|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701045|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|19.8432|||<|0.0001|2-Sided|95.0|13.7627|25.9238|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701046|NCT00975481|3127425|Superiority or Other||Mean Difference (Final Values)|16.6388|||<|0.0001|2-Sided|95.0|10.5727|22.7049|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701047|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|8.6513||||0.001|2-Sided|95.0|3.5552|13.7474|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701048|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|11.0663|||<|0.0001|2-Sided|95.0|6.0281|16.1045|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701049|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|10.8623|||<|0.0001|2-Sided|95.0|5.8712|15.8535|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701050|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|1.1113|||<|0.6697|2-Sided|95.0|-4.0285|6.2512|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701051|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|3.5264|||<|0.1733|2-Sided|95.0|-1.5676|8.6203|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701623|NCT00966875|3128623|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701052|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|3.3224|||<|0.1967|2-Sided|95.0|-1.7402|8.385|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701053|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|-0.3425|||<|0.8959|2-Sided|95.0|-5.5053|4.8204|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701054|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|2.0725|||<|0.4255|2-Sided|95.0|-3.0533|7.1984|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701055|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|1.8686|||<|0.4704|2-Sided|95.0|-3.2342|6.9713|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701056|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|-8.9938|||<|0.0006|2-Sided|95.0|-14.0695|-3.918|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701057|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|-1.4538|||<|0.572|2-Sided|95.0|-6.5274|3.6198|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emin, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701058|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|-23.4943|||<|0.0001|2-Sided|95.0|-29.244|-17.7445|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701059|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|-26.4618|||<|0.0001|2-Sided|95.0|-32.1455|-20.7782|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701060|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|-25.0418|||<|0.0001|2-Sided|95.0|-30.6705|-19.413|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701061|NCT00975481|3127426|Superiority or Other||Median Difference (Final Values)|-19.8414|||<|0.0001|2-Sided|95.0|-25.6435|-14.0393|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701062|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|-22.809|||<|0.0001|2-Sided|95.0|-28.5584|-17.0596|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701063|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|-21.3889|||<|0.0001|2-Sided|95.0|-27.1044|-15.6734|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701064|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|0.9683|||<|0.7431|2-Sided|95.0|-4.8567|6.7932|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701624|NCT00966875|3128623|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701065|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|-1.9993|||<|0.4957|2-Sided|95.0|-7.7832|3.7845|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701066|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|-0.5792|||<|0.8428|2-Sided|95.0|-6.3385|5.18|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701067|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|24.4625|||<|0.0001|2-Sided|95.0|18.7321|30.1929|||Mixed Models Analysis|Mixed-effect model was implemented with REML estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95% CI were obtained from the model.|
1701068|NCT00975481|3127426|Superiority or Other||Mean Difference (Final Values)|20.8096|||<|0.0001|2-Sided|95.0|15.0866|26.5327|||Mixed Models Analysis|Mixed-effect model was implemented with Restricted Maximum Likelihood (REML) estimation method and Kenward-Roger degrees of freedom algorithm.||For Emax, mixed-effect model was used which included treatment, period and sequence as fixed effects, baseline measurement as covariate where applicable, and participant nested within sequence as random effect. The estimates of adjusted mean differences and corresponding 95 percent (%) Confidence Interval (CI) were obtained from the model.|
1701069|NCT00975416|3127428|Superiority or Other|||||||0.6|||||||ANOVA|||Repeated measures anova to determine if oxytocin compared to placebo increased therpeutic alliance as measured by the working alliance inventory after 12 sessions of CBT.|
1701070|NCT00975416|3127428|Superiority or Other|||||||0.927|||||||ANOVA|||Repeated measures ANOVA to deterimine whether oxytocin increased compared to placebo measures of therapeutic alliance (as measured by the Helping alliance questionnaire) pre compared to post 12 sessions of CBT.|
1701071|NCT00975286|3127441|Superiority or Other||[Least squares (LS) mean difference|-0.32|Standard Error of the Mean|0.074|<|0.0001|2-Sided|95.0|-0.463|-0.171||Statistical testing: 2-sided at significance level=0.05. Analysis of covariance (ANCOVA) included treatment arms; randomization strata of Week -1 HbA1c (<8.0,>=8.0%) and TZD use (yes/no); country as fixed effects; baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 225 patients in each arm would provide a power of 98% (or 90%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.|
1701072|NCT00975221|3127442|Superiority or Other||LS Mean Treatment Difference|-22.79|Standard Error of the Mean|5.61|<|0.001|2-Sided|95.0|-34.01|-11.57|||ANCOVA|Analysis of covariance (ANCOVA) with baseline corrected serum calcium and baseline bisphosphonate included as covariates.|Treatment difference: cinacalcet-placebo||
1701073|NCT00975221|3127443|Superiority or Other||LS Mean Treatment Difference|-13.55|Standard Error of the Mean|1.34|<|0.001|2-Sided|95.0|-16.23|-10.88|||ANCOVA|Analysis of covariance (ANCOVA) with baseline corrected serum calcium and baseline bisphosphonate included as covariates.|Treatment difference: cinacalcet-placebo||
1701074|NCT00975221|3127444|Superiority or Other||CMH statistic|40.953|||<|0.001|||||||Cochran-Mantel-Haenszel||||
1701075|NCT00975221|3127445|Superiority or Other||Cochran-Mantel-Haenszel (CMH) statistic|39.866|||<|0.001|||||||Cochran-Mantel-Haenszel||||
1701076|NCT00975195|3127446|Superiority or Other||Mean Difference (Net)|-0.11|Standard Error of the Mean|0.05||0.0223|2-Sided|95.0|-0.21|-0.02|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701077|NCT00975195|3127447|Superiority or Other||Mean Difference (Net)|1.22|Standard Error of the Mean|0.614||0.0467|2-Sided|95.0|0.02|2.43|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701078|NCT00975195|3127448|Superiority or Other||Mean Difference (Net)|0.6|Standard Error of the Mean|0.845||0.4804|2-Sided|95.0|-1.06|2.25|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701079|NCT00975195|3127449|Superiority or Other||Mean Difference (Net)|1.35|Standard Error of the Mean|0.702||0.0551|2-Sided|95.0|-0.03|2.72|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701080|NCT00975195|3127450|Superiority or Other||Mean Difference (Net)|0.97|Standard Error of the Mean|0.728||0.1838|2-Sided|95.0|-0.46|2.4|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701081|NCT00975195|3127451|Superiority or Other||Mean Difference (Net)|-0.161|Standard Error of the Mean|0.045||0.0004|2-Sided|95.0|-0.249|-0.073|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701082|NCT00975195|3127452|Superiority or Other||Mean Difference (Net)|-0.044|Standard Error of the Mean|0.0255||0.0855|2-Sided|95.0|-0.094|0.006|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701083|NCT00975195|3127453|Superiority or Other||Mean Difference (Net)|-0.048|Standard Error of the Mean|0.0123|<|0.0001|2-Sided|95.0|-0.073|-0.024|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701084|NCT00975195|3127454|Superiority or Other||Mean Difference (Net)|2.64|Standard Error of the Mean|1.716||0.1241|2-Sided|95.0|-0.73|6.01|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1705475|NCT00911508|3136677|Superiority||Cox Proportional Hazard|0.94|||||2-Sided|95.0|0.53|1.68|||||||
1701086|NCT00975195|3127456|Superiority or Other||Mean Difference (Net)|-1.56|Standard Error of the Mean|1.669||0.349|2-Sided|95.0|-4.84|1.71|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701087|NCT00975195|3127457|Superiority or Other||Mean Difference (Net)|-1.03|Standard Error of the Mean|1.499||0.4914|2-Sided|95.0|-3.98|1.91|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701088|NCT00975195|3127458|Superiority or Other||Mean Difference (Net)|0.16|Standard Error of the Mean|0.06||0.0033|2-Sided|95.0|0.05|0.27|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701089|NCT00975195|3127459|Superiority or Other||Mean Difference (Net)|-3.53|Standard Error of the Mean|3.17||0.2663|2-Sided|95.0|-9.74|2.69|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701090|NCT00975195|3127460|Superiority or Other||Mean Difference (Net)|-0.013|Standard Error of the Mean|0.055||0.8137|2-Sided|95.0|-0.122|0.096|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701091|NCT00975195|3127461|Superiority or Other||Mean Difference (Net)|0.064|Standard Error of the Mean|0.034||0.0632|2-Sided|95.0|-0.004|0.131|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701092|NCT00975195|3127462|Superiority or Other||Mean Difference (Net)|-0.043|Standard Error of the Mean|0.0134||0.0014|2-Sided|95.0|-0.069|-0.017|||Restricted maximum likelihood|Repeated measures restricted maximum likelihood|Difference calculated as fluticasone withdrawal minus fluticasone maintenance|Week 52 visit|
1701093|NCT00975195|3127464|Superiority or Other|||||||0.3155|||||||Fisher Exact||||
1701094|NCT00975195|3127465|Superiority or Other||Rate ratio|1.05|Standard Error of the Mean|0.06||0.4342|2-Sided|95.0|0.93|1.18|||Regression, Negative binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance||
1701095|NCT00975195|3127466|Superiority or Other||Hazard Ratio (HR)|1.035||||0.5562|2-Sided|95.0|0.923|1.16|||Chi-squared||||
1701096|NCT00975195|3127467|Superiority or Other|||||||0.2083|||||||Fisher Exact||||
1701097|NCT00975195|3127468|Superiority or Other||Rate ratio|1.15|Standard Error of the Mean|0.13||0.2291|2-Sided|95.0|0.92|1.45|||Regression, Negative Binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance||
1701098|NCT00975195|3127469|Superiority or Other||Hazard Ratio (HR)|1.202||||0.0849|2-Sided|95.0|0.975|1.481|||Chi-squared|Wald's chi-square test|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance||
1701099|NCT00975195|3127470|Superiority or Other|||||||0.2269|||||||Fisher Exact||||
1701100|NCT00975195|3127471|Superiority or Other||Rate ratio|1.05|Standard Error of the Mean|0.06||0.4441|2-Sided|95.0|0.93|1.18|||Regression, Negative Binomial|Adjusted for log time at risk using log link function|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance||
1701101|NCT00975195|3127472|Non-Inferiority or Equivalence|Upper limit of 95% confidence interval (CI) <1.2 indicates non-inferiority of Fluticasone withdrawal compared with Fluticasone maintenance|Hazard Ratio (HR)|1.058||||0.3497|2-Sided|95.0|0.941|1.189||Two-sided p-value to test superiority of fluticasone maintenance over fluticasone withdrawal if non-inferiority shown.|Chi-squared|Wald's chi-square test|Ratio calculated as fluticasone withdrawal divided by fluticasone maintenance||
1701102|NCT00975143|3127475|Non-Inferiority or Equivalence|Pre-defined criterion for non-inferiority: lower bound of the 95% CI for the treatment difference > -10.|Proportion difference|-2.1|||>|0.05|2-Sided|95.0|-7.94|3.74|||Normal approximation||||
1701103|NCT00975143|3127476|Non-Inferiority or Equivalence|If the two co-primary endpoints were significant, a 95% 2 sided CI on the difference between treatments (CIP-Isotretinoin minus Isotretinoin) was calculated.|Proportion difference|-3.48|||>|0.05|2-Sided|95.0|-8.4|1.4|||Normal approximation|95% CI on difference in proportions (CIP-Isotretinoin minus Isotretinoin) was estimated using normal approximation.||The analysis of the secondary efficacy endpoint was based on observed cases only, with no imputation for missing values.|
1701104|NCT00975143|3127477|Non-Inferiority or Equivalence|Pre-defined criterion for non-inferiority: upper bound of the 95% CI for the treatment difference < 4.|LS Mean Difference|0.1382||||0.5077|2-Sided|95.0|-0.2712|0.5475||P values are from analysis of covariance (ANCOVA) controlling for Baseline total nodular lesion count, gender and analysis site.|ANCOVA|The 95% CI of the adjusted least square mean difference (CIP-ISOTRETINOIN minus Isotretinoin) was calculated using the ANCOVA model.||Change from Baseline was calculated as the post-Baseline value minus the Baseline value|
1701105|NCT00975000|3127654|Superiority or Other||Difference|-1.42||||0.846|2-Sided|95.0|-15.91|13.06|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in urine phosphorus between the 2 treatment groups (cinacalcet – placebo)||
1701106|NCT00975000|3127655|Superiority or Other||Difference|-117.21||||0.002|2-Sided|95.0|-189.88|-44.55|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in iPTH between the 2 treatment groups (cinacalcet – placebo)||
1701107|NCT00975000|3127656|Superiority or Other||Difference|-1.39|||<|0.001|2-Sided|95.0|-1.62|-1.16|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in corrected total calcium between the 2 treatment groups (cinacalcet – placebo)||
1701108|NCT00975000|3127657|Superiority or Other||Difference|-0.4||||0.842|2-Sided|95.0|-4.37|3.57|||ANCOVA|ANCOVA with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in mean eGFR between the 2 treatment groups (cinacalcet – placebo)||
1701109|NCT00975000|3127658|Superiority or Other||Difference|0.45|||<|0.001|2-Sided|95.0|0.26|0.64|||ANCOVA|Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the absolute change in mean serum phosphorus between the 2 treatment groups (cinacalcet – placebo)||
1701110|NCT00975000|3127659|Superiority or Other||Difference|1.41||||0.266|2-Sided|95.0|-1.1|3.93|||ANCOVA|Analysis of covariance (ANCOVA) with Baseline corrected total serum calcium group as a covariate.|Least square estimate for the difference in the percent change in BMD between the 2 treatment groups (cinacalcet – placebo)||
1701111|NCT00975000|3127660|Superiority or Other||Difference|75.44|||||2-Sided|95.0|63.83|87.05|||||Difference = Cinacalcet-Placebo||
1701112|NCT00975000|3127660|Superiority or Other||Odds Ratio (OR)|91.41|||||2-Sided|95.0|18.76|445.41|||||Odds ratio of Cinacalcet/Placebo||
1701113|NCT00975000|3127660|Superiority or Other||Chi-Square test statistic|66.437|||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by baseline corrected total serum calcium level (≤ 11.2 mg/dL and > 11.2 mg/dL)||The primary endpoint was tested at a significance level of 0.05.|
1701114|NCT00974974|3127662|Superiority or Other (legacy)||||||<|0.0001|||||||ANCOVA||||
1701115|NCT00974974|3127663|Superiority or Other (legacy)||||||<|0.0001|||||||ANCOVA||||
1701116|NCT00974311|3127712|Superiority or Other||Difference in Rate of Pain Palliation|38.2||||0.0079|2-Sided|95.0|19.4|57.0|||Cochran-Mantel-Haenszel|Stratified by baseline Eastern Cooperative Oncology Group performance status (0–1 vs. 2).|Confidence Interval based on standard normal approximation.||
1701117|NCT00974311|3127713|Superiority or Other||Hazard Ratio (HR)|0.248|||<|0.0001|2-Sided|95.0|0.204|0.303||Stratified by baseline ECOG performance status and mean Brief Pain Inventory – Short Form score (Question #3).|Log Rank||Hazard Ratio and 95% confidence interval are from Cox regression model.||
1701118|NCT00974311|3127714|Superiority or Other||Difference in Percentage of Participants|24.9|||<|0.0001|2-Sided|95.0|18.8|30.9|||Cochran-Mantel-Haenszel|Stratified by baseline ECOG performance status and mean Brief Pain Inventory – Short Form score (Question #3).|Confidence Interval based on standard normal approximation.||
1701119|NCT00974311|3127715|Superiority or Other||Hazard Ratio (HR)|0.69||||0.0001|2-Sided|95.0|0.566|0.835|||Log Rank|Stratified by baseline ECOG performance status and mean Brief Pain Inventory – Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.||
1701120|NCT00974311|3127716|Superiority or Other||Hazard Ratio (HR)|0.4|||<|0.0001|2-Sided|95.0|0.35|0.47|||Log Rank|Stratified by baseline ECOG performance status and mean Brief Pain Inventory – Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.||
1701121|NCT00974311|3127717|Superiority or Other||Hazard Ratio (HR)|0.63|||<|0.0001|2-Sided|95.0|0.53|0.75|||Log Rank|Stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status and mean Brief Pain Inventory – Short Form score (Question #3).|Hazard Ratio and 95% confidence interval are from Cox regression model.||
1701122|NCT00973973|3127759|Superiority||Difference|30.2||||0.0007|2-Sided|95.0|13.6|46.7|||Pearson chi-squared|||Comparison of response rates at week 8|
1701123|NCT00973973|3127759|Superiority||Difference|19.4||||0.0136|2-Sided|95.0|4.4|34.4|||Pearson chi-squared|||Comparison of response rates at week 4|
1701124|NCT00973973|3127761|Superiority||LS Mean Difference|-1.0|Standard Error of the Mean|0.26||0.0002|2-Sided|95.0|-1.5|-0.5|||ANOVA|||Comparison of Patient Global Impression of Change at week 8|
1701125|NCT00973973|3127761|Superiority||LS Mean Difference|-0.8|Standard Error of the Mean|0.23||0.0012|2-Sided|95.0|-1.2|-0.3|||ANOVA|||Comparison of Patient Global Impression of Change at week 4|
1701126|NCT00973973|3127763|Superiority||LS Mean Difference|-0.29|Standard Error of the Mean|0.125||0.024|2-Sided|95.0|-0.53|-0.04|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of induration score|
1701127|NCT00973973|3127763|Superiority||LS Mean Difference|-0.39|Standard Error of the Mean|0.143||0.0081|2-Sided|95.0|-0.67|-0.1|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of pelvic tenderness score|
1701128|NCT00973973|3127763|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.173||0.1052|2-Sided|95.0|-0.63|0.06|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of dyspareunia score|
1701129|NCT00973973|3127763|Superiority||LS Mean Difference|-0.36|Standard Error of the Mean|0.143||0.0139|2-Sided|95.0|-0.64|-0.07|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of non-menstrual pelvic pain score|
1701130|NCT00973973|3127763|Superiority||LS Mean Difference|-1.05|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.41|-0.69|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline in CPSSS component of dysmenorrhea score|
1701131|NCT00973973|3127763|Superiority||LS Mean Difference|-2.26|Standard Error of the Mean|0.505|<|0.0001|2-Sided|95.0|-3.26|-1.26|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of the change from baseline in CPSSS total score|
1701132|NCT00973973|3127765|Superiority||LS Mean Difference|-3.52|Standard Error of the Mean|1.938||0.072|2-Sided|95.0|-7.35|0.32|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8|
1701133|NCT00973973|3127765|Superiority||LS Mean Difference|-3.12|Standard Error of the Mean|1.821||0.0893|2-Sided|95.0|-6.72|0.49|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4|
1701134|NCT00973973|3127767|Superiority||LS Mean Difference|-6.35|Standard Error of the Mean|2.549||0.0141|2-Sided|95.0|-11.39|-1.3|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8|
1701135|NCT00973973|3127767|Superiority||LS Mean Difference|-6.21|Standard Error of the Mean|2.728||0.0244|2-Sided|95.0|-11.61|-0.81|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4|
1701136|NCT00973973|3127769|Superiority||LS Mean Difference|-12.44|Standard Error of the Mean|3.913||0.0019|2-Sided|95.0|-20.19|-4.7|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8|
1701137|NCT00973973|3127769|Superiority||LS Mean Difference|-9.84|Standard Error of the Mean|3.939||0.0137|2-Sided|95.0|-17.63|-2.05|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 4|
1701138|NCT00973973|3127775|Superiority||LS Mean Difference|-0.38|Standard Error of the Mean|0.137||0.007|2-Sided|95.0|-0.65|-0.11|||ANCOVA|ANCOVA model including baseline value as a covariate.||Comparison of change from baseline at week 8|
1701144|NCT00973973|3127781|Superiority||LS Mean Difference|-0.76|Standard Error of the Mean|0.152|<|0.0001|2-Sided|95.0|-1.06|-0.46|||ANCOVA|Analysis of covariance (ANCOVA) model, including baseline value as a covariate.||Comparison of change from baseline at week 8|
1701145|NCT00973973|3127781|Superiority||LS Mean Difference|-0.24|Standard Error of the Mean|0.107|<|0.0262|2-Sided|95.0|-0.45|-0.03|||ANCOVA|Analysis of covariance (ANCOVA) model including baseline value as a covariate.||Comparison of Change from Baseline at Week 4|
1701146|NCT00973921|3127782|Superiority or Other||Correlation coefficient|0.5||||0.0034|||||||Bland-Altman||||
1701147|NCT00973921|3127784|Superiority or Other||Correlation coefficient|0.74|||<|0.0001|||||||Bland Altman||||
1701148|NCT00973921|3127785|Superiority or Other||Proportion|1.0|||<|0.01|2-Sided|95.0|0.86|1.0|||Wilson|||The 95% confidence Interval (CI) of the primary outcome has been calculated using the Wilson method of estimating the CI of a single proportion|
1701149|NCT00973674|3127805|Superiority or Other (legacy)|||||||0.35|||||||t-test, 2 sided||||
1701150|NCT00973674|3127806|Superiority or Other (legacy)||Hazard Ratio (HR)|1.67||||0.033|2-Sided|95.0|0.74|3.77|||Log Rank||||
1701151|NCT00973674|3127807|Superiority or Other (legacy)|||||||0.99|||||||Barnard's unconditional Exact Test||||
1701152|NCT00973479|3127809|Superiority or Other||||||<|0.001|||||||ANOVA of van der Waerden scores||||
1701153|NCT00973479|3127810|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1701154|NCT00973479|3127811|Superiority or Other||||||<|0.001|||||||ANOVA of van der Waerden scores||||
1701155|NCT00973479|3127812|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1701156|NCT00973479|3127813|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1701157|NCT00973362|3127814|Superiority or Other||Prevalence(%)|10.3|||||2-Sided||||||||||
1701158|NCT00973362|3127814|Superiority or Other||NPV(%)|97.7|||||2-Sided|95.0|96.2|98.8|||||||
1701159|NCT00973362|3127814|Superiority or Other||PPV(%)|18.7|||||2-Sided|95.0|17.0|20.4|||||||
1701160|NCT00973362|3127814|Superiority or Other||Specificity(%)|55.8|||||2-Sided|95.0|52.3|59.3|||||||
1701161|NCT00973362|3127814|Superiority or Other||Sensitivity (%)|88.8|||||2-Sided|95.0|80.5|93.8|||||||
1701162|NCT00973362|3127815|Superiority or Other||Prevalence (%)|9.7|||||2-Sided||||||||||
1701163|NCT00973362|3127815|Superiority or Other||NPV|97.8|||||2-Sided|95.0|96.5|98.8|||||||
1701164|NCT00973362|3127815|Superiority or Other||PPV|20.1|||||2-Sided|95.0|18.1|22.0|||||||
1701165|NCT00973362|3127815|Superiority or Other||Specificty|62.9|||||2-Sided|95.0|59.6|66.0|||||||
1701166|NCT00973362|3127815|Superiority or Other||Sensitivity(%)|86.8|||||2-Sided|95.0|78.4|92.3|||||||
1701167|NCT00973362|3127816|Superiority or Other||Relative Risk|4.9|||||2-Sided|95.0|1.4|16.7|||||The relative risk of CIN2+ is defined as the [ absolute risk of FDA-Approved HPV DNA Assay (Positive Result) / absolute risk of FDA-Approved HPV DNA Assay (Negative Result) ] .||
1701168|NCT00973362|3127816|Superiority or Other||Prevalence (%)|2.4|||||2-Sided||||||||||
1701169|NCT00973362|3127816|Superiority or Other||Negative Predictive Value [NPV] (%)|99.2|||||2-Sided|95.0|98.1|99.8|||||||
1701170|NCT00973362|3127816|Superiority or Other||Positive Predictive Value [PPV] (%)|3.8|||||2-Sided|95.0|2.9|4.4|||||||
1701171|NCT00973362|3127816|Superiority or Other||Specificity (%)|48.7|||||2-Sided|95.0|45.2|52.2|||||||
1701172|NCT00973362|3127816|Superiority or Other||Sensitivity (%)|84.2|||||2-Sided|95.0|62.4|94.5|||||||
1701173|NCT00973362|3127817|Superiority or Other||Relative Risk|4.8|||||2-Sided|95.0|1.8|13.1|||||The relative risk of CIN2+ is defined as the [ absolute risk of APTIMA HPV (Positive Result) / absolute risk of APTIMA HPV (Negative Result) ] .||
1701174|NCT00973362|3127817|Superiority or Other||Prevalence (%)|2.4|||||2-Sided||||||||||
1701175|NCT00973362|3127817|Superiority or Other||Negative Predictive Value [NPV] (%)|99.0|||||2-Sided|95.0|98.1|99.6|||||||
1701176|NCT00973362|3127817|Superiority or Other||Positive Predictive Value [PPV] (%)|4.8|||||2-Sided|95.0|3.4|5.8|||||||
1701177|NCT00973362|3127817|Superiority or Other||Specificity (%)|62.6|||||2-Sided|95.0|59.2|65.9|||||||
1701178|NCT00973362|3127817|Superiority or Other||Sensitivity (%)|75.0|||||2-Sided|95.0|53.1|88.8|||||||
1701179|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.178|||||2-Sided|95.0|0.931|1.489|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701180|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.856|||||2-Sided|95.0|0.675|1.084|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint|
1701181|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.727|||||2-Sided|95.0|0.574|0.919|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint|
1701182|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.75|||||2-Sided|95.0|0.593|0.949|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701183|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.637|||||2-Sided|95.0|0.504|0.804|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701184|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.876|||||2-Sided|95.0|0.692|1.109|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint|
1705476|NCT00911508|3136678|Superiority||Cox Proportional Hazard|0.88|||||2-Sided|95.0|0.72|1.09|||||||
1701185|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.912|||||2-Sided|95.0|0.719|1.157|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701186|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.775|||||2-Sided|95.0|0.612|0.981|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint|
1701187|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.066|||||2-Sided|95.0|0.841|1.352|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint|
1701188|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.217|||||2-Sided|95.0|0.961|1.541|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint|
1701189|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.646|||||2-Sided|95.0|0.511|0.817|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint|
1701190|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.549|||||2-Sided|95.0|0.435|0.692|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint|
1701191|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.755|||||2-Sided|95.0|0.597|0.954|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint|
1701192|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.862|||||2-Sided|95.0|0.683|1.088|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701193|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.708|||||2-Sided|95.0|0.56|0.896|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701194|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.511|||||2-Sided|95.0|0.403|0.647|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701195|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.434|||||2-Sided|95.0|0.342|0.549|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701196|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at 43|0.597|||||2-Sided|95.0|0.47|0.757|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701197|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at 43|0.681|||||2-Sided|95.0|0.538|0.862|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701198|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at 43|0.56|||||2-Sided|95.0|0.441|0.71|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701199|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at 43|0.79|||||2-Sided|95.0|0.625|1.0|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701200|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.646|||||2-Sided|95.0|0.51|0.817|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701201|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.548|||||2-Sided|95.0|0.434|0.693|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701202|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.754|||||2-Sided|95.0|0.596|0.956|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint|
1701203|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.861|||||2-Sided|95.0|0.681|1.089|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint|
1701570|NCT00967330|3128543|Superiority or Other||LS Mean Difference|1.6126||||0.7219|2-Sided|95.0|-7.2953|10.5205|||ANOVA|||Social Functioning. ANOVA included all post-baseline data (Months 3 through 21).|
1701204|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.708|||||2-Sided|95.0|0.558|0.897|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701205|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|0.999|||||2-Sided|95.0|0.791|1.262|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701206|NCT00973349|3127826|Non-Inferiority or Equivalence|The 2-sided CIs were examined against a non-inferiority margin of 0.67|Geometric mean ratio at day 43|1.265|||||2-Sided|95.0|0.998|1.603|||||Pairwise Comparisons of GMTs (95% CI) Between Vaccination Groups at Day 43, on the pooled age groups.|Two-sided 95% CI around the point estimates were to be presented for each endpoint.|
1701207|NCT00973102|3127828|Superiority or Other (legacy)|||||||0.895|||||||t-test, 2 sided||||
1701208|NCT00973102|3127829|Superiority or Other (legacy)||Hazard Ratio (HR)|2.47||||0.252|2-Sided|95.0|1.16|5.25|||Barnard's unconditional Exact Test||||
1701209|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.597|||||2-Sided|95.0|2.646|4.89||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other|
1701210|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.56|||||2-Sided|95.0|1.886|3.474||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701211|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.712|||||2-Sided|95.0|0.524|0.966||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701212|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.718|||||2-Sided|95.0|0.529|0.975||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701213|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.2|||||2-Sided|95.0|0.147|0.271||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701214|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.281|||||2-Sided|95.0|0.207|0.38||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701215|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.31|||||2-Sided|95.0|2.436|4.496||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other|
1701216|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.92|||||2-Sided|95.0|0.677|1.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701373|NCT00972244|3127990|Superiority or Other||Risk Difference (RD)|7.7||||0.205|2-Sided|95.0|-2.0|19.5||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0|
1701625|NCT00966875|3128623|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701217|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|1.293|||||2-Sided|95.0|0.954|1.753||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701218|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|4.608|||||2-Sided|95.0|3.398|6.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701219|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.303|||||2-Sided|95.0|1.7|3.121||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701220|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.64|||||2-Sided|95.0|0.472|0.868||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701221|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.9|||||2-Sided|95.0|0.665|1.218||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701222|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.207|||||2-Sided|95.0|2.368|4.343||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701223|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.696|||||2-Sided|95.0|0.514|0.943||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other|
1701224|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67|Geometric Mean Ratio at day 29|0.463|||||2-Sided|95.0|0.341|0.628||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other|
1701225|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.129|||||2-Sided|95.0|0.095|0.174||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701226|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.181|||||2-Sided|95.0|0.134|0.245||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other|
1701227|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.645|||||2-Sided|95.0|0.476|0.873||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701228|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.14|||||2-Sided|95.0|0.103|0.189||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701229|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.201|||||2-Sided|95.0|0.149|0.272||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701230|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|2.513|||||2-Sided|95.0|1.846|3.421||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701231|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.699|||||2-Sided|95.0|0.513|0.95||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other|
1701232|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.982|||||2-Sided|95.0|0.722|1.334||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701233|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|3.499|||||2-Sided|95.0|2.577|4.751||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other|
1701234|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|0.759|||||2-Sided|95.0|0.559|1.031||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701235|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|1.091|||||2-Sided|95.0|0.804|1.481||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701236|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric Mean Ratio at day 29|5.428|||||2-Sided|95.0|4.0|7.365||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701237|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.407|||||2-Sided|95.0|0.88|2.249||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701238|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.312|||||2-Sided|95.0|0.831|2.071||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701239|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.932|||||2-Sided|95.0|0.583|1.492||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701240|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.662|||||2-Sided|95.0|0.414|1.056||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701241|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.47|||||2-Sided|95.0|0.293|0.754||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701242|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.504|||||2-Sided|95.0|0.316|0.805||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701243|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.576|||||2-Sided|95.0|0.987|2.516||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701244|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.12|||||2-Sided|95.0|0.689|1.821||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701245|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.202|||||2-Sided|95.0|0.754|1.915||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701246|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|2.383|||||2-Sided|95.0|1.474|3.851||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701247|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.273|||||2-Sided|95.0|0.798|2.03||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701248|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.905|||||2-Sided|95.0|0.561|1.46||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701249|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.97|||||2-Sided|95.0|0.611|1.541||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701250|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.924|||||2-Sided|95.0|1.193|3.102||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701251|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.807|||||2-Sided|95.0|0.5|1.304||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701252|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.631|||||2-Sided|95.0|0.398|1.002||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701253|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.449|||||2-Sided|95.0|0.279|0.722||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701254|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.481|||||2-Sided|95.0|0.306|0.758||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701255|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.954|||||2-Sided|95.0|0.596|1.528||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701256|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.4|||||2-Sided|95.0|0.25|0.641||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701257|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.496|||||2-Sided|95.0|0.31|0.794||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701258|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.203|||||2-Sided|95.0|0.745|1.943||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701259|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.855|||||2-Sided|95.0|0.524|1.396||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701260|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.917|||||2-Sided|95.0|0.568|1.481||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701261|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.818|||||2-Sided|95.0|1.119|2.956||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701262|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.763|||||2-Sided|95.0|0.468|1.245||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701263|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|0.945|||||2-Sided|95.0|0.583|1.533||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701264|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 387|1.906|||||2-Sided|95.0|1.177|3.087||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701265|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.615|||||2-Sided|95.0|1.115|2.339||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701266|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.656|||||2-Sided|95.0|1.15|2.385||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701267|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.025|||||2-Sided|95.0|0.714|1.473||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701268|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.684|||||2-Sided|95.0|0.473|0.99||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701269|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.424|||||2-Sided|95.0|0.294|0.61||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701270|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.413|||||2-Sided|95.0|0.288|0.592||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701374|NCT00972244|3127990|Superiority or Other||Risk Difference (RD)|3.2||||0.6203|2-Sided|95.0|-6.2|13.2||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0|
1701571|NCT00967330|3128543|Superiority or Other||LS Mean Difference|-1.8213||||0.6253|2-Sided|95.0|-9.155|5.5125|||ANOVA|||Cognitive Functioning. ANOVA included all post-baseline data (Months 3 through 21).|
1701271|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.634|||||2-Sided|95.0|1.128|2.366||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701272|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.012|||||2-Sided|95.0|0.701|1.46||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701273|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.987|||||2-Sided|95.0|0.688|1.416||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701274|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.388|||||2-Sided|95.0|1.658|3.438||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701275|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.324|||||2-Sided|95.0|0.915|1.917||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701276|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.82|||||2-Sided|95.0|0.568|1.184||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701277|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.8|||||2-Sided|95.0|0.558|1.147||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701278|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.935|||||2-Sided|95.0|1.347|2.78||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701279|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.811|||||2-Sided|95.0|0.562|1.169||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701280|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.553|||||2-Sided|95.0|0.382|0.801||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701281|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.342|||||2-Sided|95.0|0.237|0.494||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701282|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.334|||||2-Sided|95.0|0.233|0.479||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701283|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.808|||||2-Sided|95.0|0.561|1.165||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701284|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.338|||||2-Sided|95.0|0.235|0.487||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701285|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.418|||||2-Sided|95.0|0.289|0.603||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701286|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.451|||||2-Sided|95.0|1.0|2.105||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701287|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67|Geometric mean ratio at day 202|0.898|||||2-Sided|95.0|0.622|1.298||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701288|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.876|||||2-Sided|95.0|0.61|1.26||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701289|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.12|||||2-Sided|95.0|1.473|3.052||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701290|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|0.888|||||2-Sided|95.0|0.615|1.282||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701291|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|1.096|||||2-Sided|95.0|0.76|1.58||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701292|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 202|2.624|||||2-Sided|95.0|1.817|3.789||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701293|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.485|||||2-Sided|95.0|2.633|4.614||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701294|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.345|||||2-Sided|95.0|1.772|3.102||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701295|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.673|||||2-Sided|95.0|0.509|0.889||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701296|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.78|||||2-Sided|95.0|0.588|1.003||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701297|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.224|||||2-Sided|95.0|0.169|0.296||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701298|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.332|||||2-Sided|95.0|0.251|0.44||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701299|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.85|||||2-Sided|95.0|2.152|3.773||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701300|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.818|||||2-Sided|95.0|0.619|1.081||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701301|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.216|||||2-Sided|95.0|0.92|1.606||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701302|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.656|||||2-Sided|95.0|2.764|4.836||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701375|NCT00972244|3127990|Superiority or Other||Risk Difference (RD)|7.3||||0.2057|2-Sided|95.0|-2.3|18.8||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0|
1701572|NCT00967330|3128543|Superiority or Other||LS Mean Difference|-0.02278||||0.9949|2-Sided|95.0|-7.035|6.9895|||ANOVA|||Emotional Functioning. ANOVA included all post-baseline data (Months 3 through 21).|
1701303|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.149|||||2-Sided|95.0|1.624|2.843||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701304|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.616|||||2-Sided|95.0|0.466|1.815||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701305|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.916|||||2-Sided|95.0|0.694|1.211||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701306|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.756|||||2-Sided|95.0|2.083|3.647||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701307|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.754|||||2-Sided|95.0|0.57|0.997||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701308|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.504|||||2-Sided|95.0|0.381|0.668||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701309|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.145||||||95.0|0.109|0.191||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701310|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.215|||||2-Sided|95.0|0.163|0.284||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701311|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.647|||||2-Sided|95.0|0.489|0.856||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701312|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.177|||||2-Sided|95.0|0.134|0.234||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701313|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.235|||||2-Sided|95.0|0.178|0.31||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701314|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|2.509|||||2-Sided|95.0|1.891|3.33||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701315|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.72|||||2-Sided|95.0|0.544|0.954||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701316|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.07|||||2-Sided|95.0|0.808|1.417||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701317|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|3.219|||||2-Sided|95.0|2.43|4.264||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701318|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|0.88|||||2-Sided|95.0|0.665|1.166||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701319|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|1.168|||||2-Sided|95.0|0.881|1.547||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701320|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 43|4.975|||||2-Sided|95.0|3.757|6.589||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701321|NCT00972816|3127849|Non-Inferiority or Equivalence|A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|Geometric mean ratio at day 22|2.589|||||2-Sided|95.0|1.723|3.889||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701322|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.714|||||2-Sided|95.0|1.142|2.572||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701323|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.662|||||2-Sided|95.0|0.442|0.992||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701324|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.8|||||2-Sided|95.0|0.532|1.203||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other|
1701325|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.309|||||2-Sided|95.0|0.206|0.463||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701326|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.467|||||2-Sided|95.0|0.311|0.7||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701327|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|2.635|||||2-Sided|95.0|1.754|3.959||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701328|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.018|||||2-Sided|95.0|0.679|1.526||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701329|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.538|||||2-Sided|95.0|1.026|2.303||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701330|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|3.295|||||2-Sided|95.0|2.196|4.944||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701331|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.426|||||2-Sided|95.0|0.95|2.14||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701332|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.551|||||2-Sided|95.0|0.367|0.826||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701333|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.832|||||2-Sided|95.0|0.555|1.246||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701334|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.783|||||2-Sided|95.0|1.188|2.676||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701376|NCT00972244|3127990|Superiority or Other||Risk Difference (RD)|-0.2||||1|2-Sided|95.0|-9.1|7.6||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|Fisher Exact|||H0: proportion(treat) minus proportion(placebo) = 0 versus HA: proportion(treat) minus proportion(placebo) =/= 0|
1701573|NCT00967330|3128543|Superiority or Other||LS Mean Difference|-1.4704||||0.76|2-Sided|95.0|-10.9358|7.9951|||ANOVA|||Role Functioning. ANOVA included all post-baseline data (Months 3 through 21).|
1701335|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.541|||||2-Sided|95.0|0.361|0.811||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701336|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.436|||||2-Sided|95.0|0.29|0.655||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701337|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.168|||||2-Sided|95.0|0.112|0.252||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701338|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.254|||||2-Sided|95.0|0.17|0.381||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701339|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.545|||||2-Sided|95.0|0.363|0.818||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701340|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.165|||||2-Sided|95.0|0.11|0.248||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701341|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.306|||||2-Sided|95.0|0.204|0.458||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701342|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.742|||||2-Sided|95.0|1.156|2.626||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701343|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.673|||||2-Sided|95.0|0.448|1.012||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701344|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.017|||||2-Sided|95.0|0.676|1.528||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701345|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|2.178|||||2-Sided|95.0|1.449|3.276||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701346|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|0.661|||||2-Sided|95.0|0.44|0.994||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701347|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|1.222|||||2-Sided|95.0|0.813|1.838||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701348|NCT00972816|3127849|Non-Inferiority or Equivalence|For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.|Geometric mean ratio at day 22|3.998|||||2-Sided|95.0|2.659|6.009||||||A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.|
1701349|NCT00972595|3127901|Non-Inferiority or Equivalence|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.|Least-Squares Mean Ratio|0.99||||||90.0|0.93|1.05||||||"Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom~(U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the~United Kingdom (U.K.) taken orally"|
1701350|NCT00972595|3127902|Non-Inferiority or Equivalence|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.|Least-Squares Mean Ratio|0.98||||||90.0|0.93|1.03||||||Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally|
1701351|NCT00972504|3127962|Superiority or Other||Mean Difference (Final Values)|-1.07|Standard Error of the Mean|0.308||||95.0|-1.68|-0.46|||||||
1701352|NCT00972504|3127962|Superiority or Other||Mean Difference (Final Values)|-1.05|Standard Error of the Mean|0.305|||2-Sided|95.0|-1.65|-0.45|||||||
1701353|NCT00972504|3127962|Superiority or Other||Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.306|||2-Sided|95.0|-0.28|0.93|||||||
1701354|NCT00972504|3127963|Superiority or Other||Mean Difference (Final Values)|-2.792|Standard Error of the Mean|0.4224|||2-Sided|95.0|-3.626|-1.957|||||||
1701355|NCT00972504|3127963|Superiority or Other||Mean Difference (Final Values)|-1.76|Standard Error of the Mean|0.4172|||2-Sided|95.0|-2.584|-0.936|||||||
1701356|NCT00972504|3127963|Superiority or Other||Mean Difference (Final Values)|-1.041|Standard Error of the Mean|0.4194|||2-Sided|95.0|-1.87|-0.212|||||||
1701357|NCT00972504|3127964|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.07|||2-Sided|95.0|-0.5|-0.2|||||Comparison of Sneezing between Placebo and Cetirizine 10mg once daily.||
1701358|NCT00972504|3127964|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.07|||2-Sided|95.0|-0.4|-0.2|||||Comparison of Sneezing between Placebo and GSK835726 10mg once daily.||
1701359|NCT00972504|3127964|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.07|||2-Sided|95.0|-0.5|-0.2|||||Comparison of Sneezing between Placebo and GSK1004723 1000 µg once daily.||
1701360|NCT00972504|3127964|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.08|||2-Sided|95.0|-0.5|-0.2|||||Comparison of Nasal Itching between Placebo and Cetirizine 10 mg once daily.||
1701361|NCT00972504|3127964|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.08|||2-Sided|95.0|-0.5|-0.2|||||Comparison of Nasal Itching between Placebo and GSK835726 10 mg once daily.||
1701362|NCT00972504|3127964|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.08|||2-Sided|95.0|-0.4|-0.1|||||Comparison of Nasal Itching between Placebo and GSK1004723 1000 µg once daily.||
1701363|NCT00972504|3127964|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.08|||2-Sided|95.0|-0.6|-0.3|||||Comparison of Rhinorrhoea between Placebo and Cetirizine 10 mg once daily.||
1701364|NCT00972504|3127964|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.08|||2-Sided|95.0|-0.6|-0.2|||||Comparison of Rhinorrhoea between Placebo and GSK835726 10 mg once daily.||
1701365|NCT00972504|3127964|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.08|||2-Sided|95.0|-0.4|-0.1|||||Comparison of Rhinorrhoea between Placebo and GSK1004723 1000 µg once daily.||
1701366|NCT00972504|3127964|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.09|||2-Sided|95.0|-0.4|-0.1|||||Comparison of Nasal Blockage between Placebo and Cetirizine 10 mg once daily.||
1701367|NCT00972504|3127964|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.09|||2-Sided|95.0|-0.4|-0.1|||||Comparison of Nasal Blockage between Placebo and GSK835726 10 mg once daily.||
1701368|NCT00972504|3127964|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.09|||2-Sided|95.0|0.0|0.3|||||Comparison of Nasal Blockage between Placebo and GSK1004723 1000 µg once daily.||
1701369|NCT00972504|3127965|Superiority or Other||Mean Difference (Final Values)|-1.4|Standard Error of the Mean|0.27|||2-Sided|95.0|-1.9|-0.8|||||||
1701377|NCT00972244|3127991|Superiority or Other||Mean Difference (Final Values)|-41.37|Standard Error of the Mean|4.8358|<|0.0001|2-Sided|95.0|-50.9|-31.85||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1701378|NCT00972244|3127991|Superiority or Other||Mean Difference (Final Values)|-32.94|Standard Error of the Mean|4.7402|<|0.0001|2-Sided|95.0|-42.28|-23.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1701379|NCT00972244|3127991|Superiority or Other||Mean Difference (Final Values)|-29.42|Standard Error of the Mean|4.71|<|0.0001|2-Sided|95.0|-38.7|-20.14||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1701380|NCT00972244|3127991|Superiority or Other||Mean Difference (Final Values)|-26.08|Standard Error of the Mean|4.7589|<|0.0001|2-Sided|95.0|-35.45|-16.7||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a sequential closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1701381|NCT00972244|3127992|Superiority or Other||Mean Difference (Final Values)|-0.79|Standard Error of the Mean|0.1018|<|0.0001|2-Sided|95.0|-0.99|-0.59||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)|
1701382|NCT00972244|3127992|Superiority or Other||Mean Difference (Final Values)|-0.72|Standard Error of the Mean|0.099|<|0.0001|2-Sided|95.0|-0.92|-0.53||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)|
1701383|NCT00972244|3127992|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.1009|<|0.0001|2-Sided|95.0|-0.65|-0.26||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)|
1701384|NCT00972244|3127992|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.0987|<|0.0001|2-Sided|95.0|-0.67|-0.28||significant at alpha=0.015 (2-sided) applying Dunnett's adjustment. A sequential closed testing procedure was used to control Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) as fixed effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.015 applying Dunnett's adjustment, two-sided)|
1701385|NCT00972153|3127997|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.|
1701386|NCT00972153|3127998|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Descriptive statistics (means, medians, frequencies) were used to evaluate the distributions of variables. One-way analysis of variance and independent t-tests or Mann-Whitney U tests were used to compare patient and environmental characteristics between groups. Generalized estimating equations were used to evaluate the effects of group and other factors on airborne CFUs/cubic meter at the surgical site in each 10 minute interval.|
1701387|NCT00971750|3128028|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1701388|NCT00971750|3128030|Superiority or Other|||||||0.763|||||||Chi-squared||||
1701389|NCT00971633|3128038|Non-Inferiority or Equivalence|§ Study Primary Hypothesis: A single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet over-encapsulated is bioequivalent to a single dose of the U.S. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean rations (U.K. ZOFRAN tablet over-encapsulated/U.S. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.951|||||2-Sided|95.0|0.872|1.037|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.S. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally. Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally|
1701411|NCT00970632|3128127|Superiority or Other|||||||0.303||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) using rank transformed data.|||
1701412|NCT00970632|3128130|Superiority or Other|||||||0.014||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|ANOVA using rank transformed data.|||
1701390|NCT00971633|3128038|Non-Inferiority or Equivalence|Study Secondary Hypothesis: A single dose of U.K. ZOFRAN (ondansetron) 8-mg table over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K.) ZOFRAN tablet over-encapsulated/U.K. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.886|||||2-Sided|95.0|0.813|0.966|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.K. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally|
1701391|NCT00971633|3128039|Non-Inferiority or Equivalence|Study Primary Hypothesis: A single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet over-encapsulated is bioequivalent to a single dose of the U.S. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean rations (U.K. ZOFRAN tablet over-encapsulated/U.S. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.991|||||2-Sided|95.0|0.873|1.126|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.S. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally|
1701392|NCT00971633|3128039|Non-Inferiority or Equivalence|Study Secondary Hypothesis: A single dose of U.K. ZOFRAN (ondansetron) 8-mg table over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN tablet over-encapsulated/U.K. ZOFRAN tablet) of the area under the plasma concentration vs. time curve (AUC) from zero to infinity and maximum plasma concentration (Cmax) for ondansetron each lie within the interval 0.80 to 1.25.|Geometric Mean Ratio|0.904|||||2-Sided|95.0|0.796|1.028|||||Geometric Mean Ratio (Treatment OE U.K. tablet / Treatment U.K. tablet)|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally|
1701393|NCT00971620|3128044|Superiority or Other|||||||0.07|||||||Wilcoxon rank sum test||||
1701394|NCT00971620|3128046|Superiority or Other|||||||0.04|||||||Wilcoxon rank sum test||||
1701395|NCT00971620|3128047|Superiority or Other|||||||0.48|||||||Wilcoxon rank sum test||||
1701396|NCT00971620|3128048|Superiority or Other|||||||0.007|||||||WIlcoxon rank sum test||||
1701397|NCT00971620|3128049|Superiority or Other|||||||0.06|||||||Wilcoxon rank sum test||||
1701398|NCT00971620|3128051|Superiority or Other||Hodges-Lehmann|0.0||||0.7|2-Sided|95.0|-2.0|4.0|||Wilcoxon rank sum test||||
1701399|NCT00970944|3128107|Superiority or Other||Slope|-0.24|Standard Error of the Mean|0.088||0.007||95.0|-0.41|-0.07||The final analysis used a significance level of 0.045.|Mixed Models Analysis|Final analysis adjusted for early v. late enrollment relative to date of injury, baseline CRS-R rating category (MCS vs. VS), and site.||The planned sample size of 184 patients provided 80% power to detect a difference between the AH and placebo in the rate of Disability Rating Scale (DRS) score change of 0.3 points/week (1.22 DRS point mean difference by the end of the 4-week treatment interval). Two blinded interim analyses were conducted at 60 and 120 patients recruited using the O'Brien-Fleming boundary, with alpha levels of 0.0005 and 0.014. The final analysis used an alpha level of 0.045.|
1701400|NCT00970944|3128108|Superiority or Other|||||||0.045|||||||Mixed Models Analysis|||We will have 80% power to detect a one point difference in DRS score between the groups across the four week treatment window. With this sample size, we will be able to detect any unforeseen adverse events that have a prevalence of at least 2.5% in each group with 90% probability. With 92 patients per group we will be able to estimate the rate of adverse events to within ±10%.|
1701401|NCT00970853|3128109|Non-Inferiority or Equivalence|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.67|||||||t-test, 2 sided||||
1701402|NCT00970853|3128110|Non-Inferiority or Equivalence|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.61|||||||t-test, 2 sided||||
1701403|NCT00970853|3128111|Non-Inferiority or Equivalence|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.85|||||||t-test, 2 sided||||
1701404|NCT00970853|3128112|Non-Inferiority or Equivalence|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.34|||||||t-test, 2 sided||||
1701405|NCT00970853|3128113|Non-Inferiority or Equivalence|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.56|||||||t-test, 2 sided||||
1701406|NCT00970853|3128114|Non-Inferiority or Equivalence|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.4|||||||t-test, 2 sided||||
1701407|NCT00970853|3128115|Non-Inferiority or Equivalence|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.16|||||||t-test, 2 sided||||
1701408|NCT00970853|3128116|Non-Inferiority or Equivalence|In our original sample of 302, we had 80% power to detect significant differences of at least .5 standard deviation between groups.||||||0.99|||||||t-test, 2 sided||||
1701409|NCT00970853|3128117|Non-Inferiority or Equivalence|The original sample for this study (N=302) was sufficient for an 80% detection of differences in means of at least 1/2 standard deviation. This analysis presents the results of the follow-up of the original sample.||||||0.39||||||non-adjusted for multiple comparisons|t-test, 2 sided||||
1701410|NCT00970632|3128127|Superiority or Other|||||||0.146||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|ANOVA using rank transformed data.|||
1701470|NCT00969618|3128241|Superiority or Other||||||<|0.001|||||||Paired t-test||||
1701471|NCT00969618|3128242|Superiority or Other||||||<|0.001||||||P-value is for ADHD index subscale score.|Paired t-test||||
1701413|NCT00970632|3128130|Superiority or Other|||||||0.009||||||The p-value associated with median difference of changes from baseline to Week 12 endpoint between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANOVA|Analysis of variance (ANOVA) using rank transformed data.|||
1701414|NCT00970632|3128131|Superiority or Other||Difference in LS Means|-0.4||||0.699||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANCOVA||||
1701415|NCT00970632|3128131|Superiority or Other||Difference in LS Means|4.0|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|ANCOVA||||
1701416|NCT00970632|3128132|Superiority or Other||Median of Treatment Group Differences|-2.2||||0.457||||||The p-value associated with the testing for differences in medians between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 without adjustments for multiplicity.|Van Elteren Tests|P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.|||
1701417|NCT00970632|3128132|Superiority or Other||Median of Treatment Group Differences|-4.4||||0.005||||||The p-value associated with the testing for differences in medians between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Van Elteren Tests|P-values testing for differences of medians between placebo and active treatment were based on the Van Elteren test, stratifying by region.|||
1701418|NCT00970632|3128133|Superiority or Other|||||||0.452||||||The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate [total IPSS <20]; severe [total IPSS ≥20]).|||
1701419|NCT00970632|3128133|Superiority or Other|||||||0.004||||||The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and a stratification of baseline LUTS severity (moderate [total IPSS <20]; severe [total IPSS ≥20]).|||
1701420|NCT00970632|3128134|Superiority or Other|||||||0.114||||||The p-value associated with difference between tamsulosin versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate [total IPSS <20]; severe [total IPSS ≥20]).|||
1701421|NCT00970632|3128134|Superiority or Other|||||||0.001||||||The p-value associated with difference between tadalafil versus placebo treatment groups within the 7 response categories was assessed for significance at a level of 0.05 with no adjustment for multiplicity.|Cochran-Mantel-Haenszel|Analysis used data only from these treatment arms and stratification of baseline LUTS severity (moderate [total IPSS <20]; severe [total IPSS ≥20]).|||
1701422|NCT00970632|3128135|Superiority or Other||Difference in LS Means|-0.6||||0.026||95.0||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA||||
1701423|NCT00970632|3128135|Superiority or Other||Difference in LS Means|-0.8||||0.003||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA||||
1701424|NCT00970632|3128136|Superiority or Other||Difference in LS Means|-0.9|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA||||
1701425|NCT00970632|3128136|Superiority or Other||Difference in LS Means|-0.8|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA||||
1701426|NCT00970632|3128137|Superiority or Other||Difference in LS Means|-1.5||||0.005||||||The p-value associated with LS Mean difference of changes from baseline to Week 1 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA||||
1701427|NCT00970632|3128137|Superiority or Other||Difference in LS Means|-1.5||||0.003||||||The p-value associated with LS Mean difference of changes from baseline to Week 1 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA||||
1701428|NCT00970632|3128138|Superiority or Other||Difference in LS Means|-0.1||||0.546||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA||||
1701429|NCT00970632|3128138|Superiority or Other||Difference in LS Means|-0.3||||0.022||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA||||
1701430|NCT00970632|3128139|Superiority or Other||Difference in LS Means|-0.2||||0.118||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA||||
1701431|NCT00970632|3128139|Superiority or Other||Difference in LS Means|-0.2||||0.08||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA||||
1701432|NCT00970632|3128140|Superiority or Other||Difference in LS Means|-1.0||||0.026||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA||||
1701472|NCT00969618|3128242|Superiority or Other||||||<|0.001||||||P-value is for hyperactivity/impulsivity subscale score.|Paired t-test||||
1701433|NCT00970632|3128140|Superiority or Other||Difference in LS Means|-1.5|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA||||
1701434|NCT00970632|3128141|Superiority or Other||Difference in LS Means|-0.6||||0.055||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA||||
1701435|NCT00970632|3128141|Superiority or Other||Difference in LS Means|-0.6||||0.055||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tadalafil versus placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA||||
1701436|NCT00970632|3128142|Superiority or Other||Difference in LS Means|-2.3|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tamsulosin and placebo treatment groups was assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA||||
1701437|NCT00970632|3128142|Superiority or Other||Difference in LS Means|-2.2|||<|0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 4 between tadalafil and placebo treatment groups was assessed for significance at a level of 0.05.|ANCOVA||||
1701438|NCT00970632|3128143|Superiority or Other||Difference in LS Means|-1.5||||0.023||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 between tamsulosin and placebo treatment groups was secondary in nature and assessed for significance at a level of 0.05 with no adjustments for multiplicity.|ANCOVA||||
1701439|NCT00970632|3128143|Superiority or Other||Difference in LS Means|-2.1||||0.001||||||The p-value associated with LS Mean difference of changes from baseline to Week 12 endpoint between tadalafil and placebo treatment groups was for the primary comparison and assessed for significance at a level of 0.05.|ANCOVA||||
1701440|NCT00970307|3128182|Non-Inferiority|Criterion for evaluation of Non-inferiority: the upper limit of Standardized asymptotic 95% confidence interval lower or equal to 10% .|Difference in percentage|-0.72|||||2-Sided|95.0|-5.19|3.57|||||||
1701441|NCT00970307|3128183|Non-Inferiority|Criterion for evaluation of Non-inferiority: the upper limit of Standardised asymptotic 95% confidence interval lower or equal to 10% .|Difference in percentage|-0.76|||||2-Sided|95.0|-4.21|2.22|||||||
1701442|NCT00970281|3128187|Superiority or Other|||||||1||||||This is the p-value for Parkinsonism.|Fisher Exact||||
1701443|NCT00970281|3128188|Superiority or Other|||||||0.204||||||This is the p-value for the 24 hours after the first IM injection.|Fisher Exact||||
1701444|NCT00970281|3128188|Superiority or Other|||||||0.008||||||This is the p-value for the 2 hours after the first IM injection.|Fisher Exact||||
1701445|NCT00970281|3128188|Superiority or Other|||||||0.008||||||This is the p-value for the 1.5 hour after the first IM injection.|Fisher Exact||||
1701446|NCT00970281|3128188|Superiority or Other|||||||0.134||||||This is the p-value for the 1 hour after the first IM injection.|Fisher Exact||||
1701447|NCT00970281|3128188|Superiority or Other|||||||0.167||||||This is the p-value for the 0.5 hour after the first IM injection.|Fisher Exact||||
1701448|NCT00970281|3128189|Superiority or Other|||||||0.008|||||||Fisher Exact||||
1701449|NCT00970281|3128190|Superiority or Other|||||||0.008|||||||ANOVA||||
1701450|NCT00970281|3128191|Superiority or Other||||||<|0.001||||||This is the p-value for the 1.5 hour after first IM injection.|ANOVA||||
1701451|NCT00970281|3128191|Superiority or Other||||||<|0.001||||||This is the p-value for the 1 hour after first IM injection.|ANOVA||||
1701452|NCT00970281|3128191|Superiority or Other||||||<|0.001||||||This is the p-value for the 0.50 hour after first IM injection.|ANOVA||||
1701453|NCT00970281|3128191|Superiority or Other||||||<|0.009||||||This is the p-value for 0.25 hour after first IM injection.|ANOVA||||
1701454|NCT00970281|3128192|Superiority or Other||||||<|0.001||||||The p-value was based on an analysis of variance (ANOVA) model that included treatment and site as a factor.|ANOVA|||Sample size of at least 45 participants per group was necessary to verify decreases in PANSS-EC total score were significantly greater in olanzapine group than placebo group using a t-test with a power of 90% and a 2-sided significance level of 5%.|
1701455|NCT00969709|3128234|Superiority or Other||Least squares mean difference|-2.57||||0.0141|2-Sided|95.0|-4.62|-0.52|||Mixed Models Analysis|Mixed-effects model for repeated measures.|||
1701456|NCT00969709|3128234|Superiority or Other||least squares mean difference|-2.51||||0.0151|2-Sided|95.0|-4.54|-0.49|||Mixed Models Analysis|Mixed-effects model for repeated measures.|||
1701457|NCT00969709|3128234|Superiority or Other||Least squares mean difference|-1.41||||0.1687|2-Sided|95.0|-3.42|0.6|||Mixed Models Analysis|Mixed-effects model for repeated measures.|||
1701458|NCT00969709|3128235|Superiority or Other||Least squares mean difference|-4.86||||0.0005|2-Sided|95.0|-7.59|-2.12|||Mixed Models Analysis|Mixed-effects model for repeated measures.|||
1701459|NCT00969709|3128235|Superiority or Other||Least squares mean difference|-3.99||||0.0038|2-Sided|95.0|-6.69|-1.29|||Mixed Models Analysis|Mixed-effects model for repeated measures.|||
1701460|NCT00969709|3128235|Superiority or Other||Least squares mean difference|-3.23||||0.0186|2-Sided|95.0|-5.92|-0.54|||Mixed Models Analysis|Mixed-effects model for repeated measures.|||
1701461|NCT00969618|3128236|Superiority or Other|||||||0.384|||||||Paired t-test||||
1701462|NCT00969618|3128237|Superiority or Other||||||<|0.001||||||P-value is for metacognition subscale score.|Paired t-test||||
1701463|NCT00969618|3128237|Superiority or Other||||||<|0.001||||||P-value is for behavioral regulation subscale score.|Paired t-test||||
1701464|NCT00969618|3128237|Superiority or Other||||||<|0.001||||||P-value is for GEC subscale score.|Paired t-test||||
1701465|NCT00969618|3128238|Superiority or Other||||||<|0.001|||||||Paired t-test||||
1701466|NCT00969618|3128239|Superiority or Other|||||||0.2|||||||Paired t-test||||
1701467|NCT00969618|3128240|Superiority or Other||||||<|0.001||||||P-value is for metacognition subscale score.|Paired t-test||||
1701468|NCT00969618|3128240|Superiority or Other||||||<|0.001||||||P-value is for behavioral regulation subscale score.|Paired t-test||||
1701469|NCT00969618|3128240|Superiority or Other||||||<|0.001||||||P-value is GEC subscale score.|Paired t-test||||
1701475|NCT00969436|3128276|Non-Inferiority|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|2.77|||||2-Sided|95.0|-1.59|10.29||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.|
1701476|NCT00969436|3128276|Non-Inferiority|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||2-Sided|95.0|-2.48|5.02||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.|
1701477|NCT00969436|3128276|Non-Inferiority|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||2-Sided|95.0|-2.48|5.09||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.|
1701478|NCT00969436|3128276|Non-Inferiority|Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the 2-sided standardised asymptotic 95% confidence interval (CI) on the difference in the seroconversion rates between the 2 groups (Priorix/Priorix-Tetra Group minus Control Group) was ≥ -10%.|Difference in percentage|0.0|||||2-Sided|95.0|-2.46|5.09||||||Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.|
1701479|NCT00969436|3128276|Non-Inferiority|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|4.17|||||2-Sided|95.0|1.37|11.57||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.|
1701480|NCT00969436|3128276|Non-Inferiority|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||2-Sided|95.0|-2.51|5.02||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.|
1701481|NCT00969436|3128276|Non-Inferiority|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||2-Sided|95.0|-2.52|5.09||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.|
1701482|NCT00969436|3128276|Non-Inferiority|Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (Priorix-Tetra Group minus Control Group) was greater than or equal to (≥) -10%.|Difference in percentage|0.0|||||2-Sided|95.0|-2.52|5.09||||||Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.|
1701483|NCT00969150|3128300|Superiority or Other||Least squares mean difference|-0.54||||0.5625|2-Sided|95.0|-2.38|1.29|||Mixed Models Analysis|Mixed-effects model for repeated measures.|||
1701484|NCT00969150|3128301|Superiority or Other||Least squares mean difference|-1.49||||0.2492|2-Sided|95.0|-4.02|1.05|||Mixed Models Analysis|Mixed-effects model for repeated measures.|||
1701485|NCT00968812|3128344|Superiority or Other||Least-Squares Mean Difference|-0.18|Standard Error of the Mean|0.054|||2-Sided|95.0|-0.289|-0.078|||||||
1701486|NCT00968812|3128344|Superiority or Other||Least-Squares Mean Difference|-0.09|Standard Error of the Mean|0.054|||2-Sided|95.0|-0.2|0.01|||||||
1701487|NCT00968812|3128345|Superiority or Other||Least-Squares Mean Difference|-5.7|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-6.2|-5.1|||ANCOVA||||
1701488|NCT00968812|3128345|Superiority or Other||Least-Squares Mean Difference|-5.2|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|-5.7|-4.7|||ANCOVA||||
1701489|NCT00968812|3128346|Superiority or Other||Odds Ratio (OR)|0.09|||<|0.001|2-Sided|95.0|0.05|0.14|||Regression, Logistic||||
1701490|NCT00968812|3128346|Superiority or Other||Odds Ratio (OR)|0.1|||<|0.001|2-Sided|95.0|0.06|0.16|||Regression, Logistic||||
1701491|NCT00968812|3128347|Non-Inferiority or Equivalence|Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride|Least-Squares Mean Difference|-0.12|Standard Error of the Mean|0.05|||2-Sided|95.0|-0.217|-0.023||||||If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference [canagliflozin minus glimepiride] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.|
1701492|NCT00968812|3128347|Non-Inferiority or Equivalence|Power calculation: assuming a difference between canagliflozin and glimepiride of 0.0% and a common standard deviation of 1.0%, and using a 2-sample, 1-sided t-test with a Type I error rate of 0.0125, and assuming a drop-out rate of 35% in 52 weeks, it was estimated that approximately 427 patients per group would provide 90% power to demonstrate non-inferiority with the non-inferiority margin of 0.3, comparing canagliflozin with glimepiride.|Least-Squares Mean Difference|-0.01|Standard Error of the Mean|0.05|||2-Sided|95.0|-0.109|0.085||||||If the hypothesis of non-inferiority of canagliflozin to glimepiride at Week 52 was demonstrated (ie, upper bound of the 95% Confidence Interval of the treatment difference [canagliflozin minus glimepiride] was less than 0.3) and the upper bound was less than 0.0, the superiority of the canagliflozin dose relative to glimepiride would be concluded.|
1701493|NCT00968708|3128353|Non-Inferiority or Equivalence|If the upper bound of the confidence interval for the primary MACE composite was <1.0, then statistical superiority of alogliptin to placebo for the secondary MACE composite would be demonstrated.|Hazard Ratio (HR)|0.952|||||1-Sided|97.5||1.135|||||||
1701494|NCT00968708|3128354|Non-Inferiority or Equivalence|If after accrual of 550 participants with MACE events, the upper bound of a 1-sided repeated CI for the hazard ratio (alogliptin to placebo) was <1.0, superiority of alogliptin to placebo for the primary MACE composite would be concluded. If the upper bound of the 1-sided repeated CI for the hazard ratio of the primary MACE composite was <1.3 but ≥1.0 then non-inferiority but not superiority of alogliptin to placebo was to be concluded.|Hazard Ratio (HR)|0.965||||0.332|1-Sided|97.5||1.169||Stratified by endpoint renal function (defined as the last observed postbaseline renal function (normal renal function/mild renal impairment vs moderate/severe renal impairment including end-stage renal disease)) and geographic region.|Cox proportional hazards|||Stratified by endpoint renal function and geographic region|
1701495|NCT00968708|3128354|Non-Inferiority or Equivalence|If after accrual of 550 participants with MACE events, the upper bound of a 1-sided repeated CI for the hazard ratio (alogliptin to placebo) was <1.0, superiority of alogliptin to placebo for the primary MACE composite would be concluded. If the upper bound of the 1-sided repeated CI for the hazard ratio of the primary MACE composite was <1.3 but ≥1.0 then non-inferiority but not superiority of alogliptin to placebo was to be concluded.|Hazard Ratio (HR)|0.962||||0.315|1-Sided|97.5||1.16|||Cox proportional hazards|||Statistical analyses of the primary MACE composite endpoint was based on sequences of 1-sided repeated confidence intervals (CIs) to assess non-inferiority or statistical superiority with respect to the null hypotheses. Each sequence of repeated CIs was constructed using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%. Each sequence of 1-sided repeated CIs had a simultaneous coverage probability of 97.5%.|
1701496|NCT00968669|3128360|Superiority or Other|||||||0.574|||||||Fisher Exact|||Combined MEDI-528 dose groups versus placebo|
1701497|NCT00968669|3128361|Superiority or Other|||||||0.208|||||||Fisher Exact|||Combined MEDI-528 dose groups versus placebo|
1701498|NCT00968669|3128362|Superiority or Other|||||||0.968|||||||Two-sample t-test||||
1701499|NCT00968669|3128362|Superiority or Other|||||||0.847|||||||Two-sample t-test||||
1701500|NCT00968669|3128362|Superiority or Other|||||||0.409|||||||Two-sample t-test||||
1701501|NCT00968669|3128363|Superiority or Other|||||||0.224|||||||Two-sample t-test||||
1701502|NCT00968669|3128363|Superiority or Other|||||||0.756|||||||Two-sample t-test||||
1701503|NCT00968669|3128363|Superiority or Other|||||||0.837|||||||Two-sample t-test||||
1701504|NCT00968669|3128364|Superiority or Other||Hazard Ratio (HR)|0.887||||0.5184|||||||Log Rank|Stratified by atopic asthma status and steroid use|||
1701505|NCT00968669|3128364|Superiority or Other||Hazard Ratio (HR)|0.928||||0.5086|||||||Log Rank|Stratified by atopic asthma status and steroid use|||
1701506|NCT00968669|3128364|Superiority or Other||Hazard Ratio (HR)|0.952||||0.712|||||||Log Rank|Stratified by atopic asthma status and steroid use|||
1701507|NCT00968669|3128365|Superiority or Other||Hazard Ratio (HR)|0.909||||0.6182|||||||Log Rank|Stratified by atopic asthma status and steroid use|||
1701508|NCT00968669|3128365|Superiority or Other||Hazard Ratio (HR)|0.942||||0.6219|||||||Log Rank|Stratified by atopic asthma status and steroid use|||
1701509|NCT00968669|3128365|Superiority or Other||Hazard Ratio (HR)|0.955||||0.7171|||||||Log Rank|Stratified by atopic asthma status and steroid use|||
1701510|NCT00968669|3128366|Superiority or Other|||||||0.986|||||||Fisher Exact|||Combined MEDI-528 treatment was compared to placebo|
1701511|NCT00968669|3128367|Superiority or Other|||||||0.764|||||||Fisher Exact|||Combined MEDI-528 treatment was compared to placebo|
1701512|NCT00968669|3128368|Superiority or Other|||||||0.303|||||||ANOVA||||
1701513|NCT00968669|3128368|Superiority or Other|||||||0.29|||||||ANOVA||||
1701514|NCT00968669|3128368|Superiority or Other|||||||0.813|||||||ANOVA||||
1701515|NCT00968669|3128369|Superiority or Other||Hazard Ratio (HR)|0.955||||0.934|||||||Log Rank|Stratified by atopic asthma status and steroid use|||
1701516|NCT00968669|3128369|Superiority or Other||Hazard Ratio (HR)|0.467||||0.07|||||||Log Rank|Stratified by atopic asthma status and steroid use|||
1701517|NCT00968669|3128369|Superiority or Other||Hazard Ratio (HR)|1.162||||0.717|||||||Log Rank|Stratified by atopic asthma and steroid use|||
1701518|NCT00968669|3128370|Superiority or Other||Hazard Ratio (HR)|0.899||||0.863|||||||Log Rank|Stratified by atopic asthma status and steroid use|||
1701519|NCT00968669|3128370|Superiority or Other||Hazard Ratio (HR)|0.618||||0.395|||||||Log Rank|Stratified by atopic asthma status and steroid use|||
1701520|NCT00968669|3128370|Superiority or Other||Hazard Ratio (HR)|1.938||||0.144|||||||Log Rank|Stratified by atopic asthma and steroid use|||
1701521|NCT00968669|3128371|Superiority or Other|||||||1|||||||Fisher Exact||||
1701522|NCT00968669|3128371|Superiority or Other|||||||0.0811|||||||Fisher Exact||||
1701523|NCT00968669|3128371|Superiority or Other|||||||0.8475|||||||Fisher Exact||||
1701524|NCT00968669|3128372|Superiority or Other|||||||1|||||||Fisher Exact||||
1701525|NCT00968669|3128372|Superiority or Other|||||||0.4031|||||||Fisher Exact||||
1701526|NCT00968669|3128372|Superiority or Other|||||||0.1764|||||||Fisher Exact||||
1701527|NCT00968669|3128373|Superiority or Other|||||||1|||||||Pairwise Poisson Regression||||
1701538|NCT00967694|3128514|Superiority or Other||||||>|0.05|||||||Mixed Models Analysis|||A linear mixed effects model was used to assess change in IOP over time using time-points as the primary independent variable with significance set at p < 0.05. Power calculations showed that 20 subjects would allow detection of a 2.8-mmHg difference in IOP between any two time-points with 80% power assuming a standard deviation of 3.5 mmHg for IOP and a correlation between two time- points of 0.25|
1701539|NCT00967668|3128516|Superiority or Other||||||<|0.05|||||||Regression, Linear|Linear mixed-effects model with baseline, 3- and 12-month outcome values modeled as dependent variables||All participants were included in outcomes analyses using intention-to-treat principles. A linear mixed-effects model with baseline, 3- and 12-month outcome values modeled as dependent variables was used.This statistical approach allows the use of data from all participants as long as the dependent variable is available for at least one time point. Each subject was included as a random intercept to adjust for within-person correlations.|
1701540|NCT00967486|3128524|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1701541|NCT00967330|3128540|Superiority or Other||LS Mean Difference|-2.151||||0.2078|2-Sided|95.0|-5.4983|1.1963|||ANOVA|||KPS score. ANOVA included all post-baseline data (Months 3 through 21).|
1701542|NCT00967330|3128541|Superiority or Other||LS Mean Difference|-0.3128||||0.4717|2-Sided|95.0|-1.1658|0.5402|||ANOVA|||Total score. ANOVA included all post-baseline data (Months 3 through 21).|
1701543|NCT00967330|3128541|Superiority or Other||LS Mean Difference|-0.08037||||0.4464|2-Sided|95.0|-0.2875|0.1268|||ANOVA|||Language and construct ability. ANOVA included all post-baseline data (Months 3 through 21).|
1701544|NCT00967330|3128541|Superiority or Other||LS Mean Difference|-0.03782||||0.661|2-Sided|95.0|-0.2071|0.1315|||ANOVA|||Short-term verbal memory. ANOVA included all post-baseline data (Months 3 through 21).|
1701545|NCT00967330|3128541|Superiority or Other||LS Mean Difference|0.003262||||0.9836|2-Sided|95.0|-0.3092|0.3158|||ANOVA|||Calculations. ANOVA included all post-baseline data (Months 3 through 21).|
1701546|NCT00967330|3128541|Superiority or Other||LS Mean Difference|0.1429||||0.2608|2-Sided|95.0|-0.1065|0.3924|||ANOVA|||Repetitions required. ANOVA included all post-baseline data (Months 3 through 21).|
1701547|NCT00967330|3128541|Superiority or Other||LS Mean Difference|-0.02955||||0.0773|2-Sided|95.0|-0.06234|0.003241|||ANOVA|||Immediate recall. ANOVA included all post-baseline data (Months 3 through 21).|
1701548|NCT00967330|3128541|Superiority or Other||LS Mean Difference|-0.1933||||0.0817|2-Sided|95.0|-0.411|0.02438|||ANOVA|||Orientation to time and place. ANOVA included all post-baseline data (Months 3 through 21).|
1701549|NCT00967330|3128542|Superiority or Other||LS Mean Difference|0.469||||0.841|2-Sided|95.0|-4.1211|5.0591|||ANOVA|||Bladder control. ANOVA included all post-baseline data (Months 3 through 21).|
1701550|NCT00967330|3128542|Superiority or Other||LS Mean Difference|-1.0341||||0.7755|2-Sided|95.0|-8.1508|6.0827|||ANOVA|||Weakness of legs. ANOVA included all post-baseline data (Months 3 through 21).|
1701551|NCT00967330|3128542|Superiority or Other||LS Mean Difference|0.9807||||0.7491|2-Sided|95.0|-5.0373|6.9988|||ANOVA|||Itchy skin. ANOVA included all post-baseline data (Months 3 through 21).|
1701552|NCT00967330|3128542|Superiority or Other||LS Mean Difference|-4.5908||||0.2383|2-Sided|95.0|-12.2279|3.0464|||ANOVA|||Hair loss. ANOVA included all post-baseline data (Months 3 through 21).|
1701553|NCT00967330|3128542|Superiority or Other||LS Mean Difference|-3.4399||||0.3458|2-Sided|95.0|-10.6002|3.7204|||ANOVA|||Drowsiness. ANOVA included all post-baseline data (Months 3 through 21).|
1701554|NCT00967330|3128542|Superiority or Other||LS Mean Difference|-1.0054||||0.5997|2-Sided|95.0|-4.7654|2.7545|||ANOVA|||Seizures. ANOVA included all post-baseline data (Months 3 through 21).|
1701555|NCT00967330|3128542|Superiority or Other||LS Mean Difference|-8.3294||||0.0124|2-Sided|95.0|-14.855|-1.8037|||ANOVA|||Headaches. ANOVA included all post-baseline data (Months 3 through 21).|
1701556|NCT00967330|3128542|Superiority or Other||LS Mean Difference|-0.1009||||0.9706|2-Sided|95.0|-5.468|5.2663|||ANOVA|||Communication deficit. ANOVA included all post-baseline data (Months 3 through 21).|
1701557|NCT00967330|3128542|Superiority or Other||LS Mean Difference|1.1014||||0.686|2-Sided|95.0|-4.2449|6.4477|||ANOVA|||Motor dysfunction. ANOVA included all post-baseline data (Months 3 through 21).|
1701558|NCT00967330|3128542|Superiority or Other||LS Mean Difference|-1.1159||||0.6146|2-Sided|95.0|-5.4654|3.2336|||ANOVA|||Visual disorder. ANOVA included all post-baseline data (Months 3 through 21).|
1701559|NCT00967330|3128542|Superiority or Other||LS Mean Difference|-3.2699||||0.3613|2-Sided|95.0|-10.2983|3.7585|||ANOVA|||Future uncertainty. ANOVA included all post-baseline data (Months 3 through 21).|
1701560|NCT00967330|3128543|Superiority or Other||LS Mean Difference|-2.7295||||0.5201|2-Sided|95.0|-11.0727|5.6137|||ANOVA|||Financial Problems. ANOVA included all post-baseline data (Months 3 through 21).|
1701561|NCT00967330|3128543|Superiority or Other||LS Mean Difference|-6.1685||||0.0213|2-Sided|95.0|-11.4129|-0.9241|||ANOVA|||Diarrhoea. ANOVA included all post-baseline data (Months 3 through 21).|
1701562|NCT00967330|3128543|Superiority or Other||LS Mean Difference|-3.9375||||0.275|2-Sided|95.0|-11.0245|3.1495|||ANOVA|||Constipation. ANOVA included all post-baseline data (Months 3 through 21).|
1701563|NCT00967330|3128543|Superiority or Other||LS Mean Difference|-2.782||||0.4081|2-Sided|95.0|-9.3926|3.8282|||ANOVA|||Appetite loss. ANOVA included all post-baseline data (Months 3 through 21).|
1701564|NCT00967330|3128543|Superiority or Other||LS Mean Difference|-4.876||||0.2884|2-Sided|95.0|-13.9002|4.1482|||ANOVA|||Insomnia. ANOVA included all post-baseline data (Months 3 through 21).|
1701565|NCT00967330|3128543|Superiority or Other||LS Mean Difference|-3.2088||||0.3724|2-Sided|95.0|-10.2784|3.8608|||ANOVA|||Dyspnoea. ANOVA included all post-baseline data (Months 3 through 21).|
1701566|NCT00967330|3128543|Superiority or Other||LS Mean Difference|-9.095||||0.0354|2-Sided|95.0|-17.5629|-0.6271|||ANOVA|||Pain. ANOVA included all post-baseline data (Months 3 through 21).|
1701567|NCT00967330|3128543|Superiority or Other||LS Mean Difference|-4.196||||0.0485|2-Sided|95.0|-8.3635|-0.0285|||ANOVA|||Nausea/Vomiting. ANOVA included all post-baseline data (Months 3 through 21).|
1701568|NCT00967330|3128543|Superiority or Other||LS Mean Difference|-3.3449||||0.3287|2-Sided|95.0|-10.0739|3.3841|||ANOVA|||Fatigue. ANOVA included all post-baseline data (Months 3 through 21).|
1701569|NCT00967330|3128543|Superiority or Other||LS Mean Difference|3.4989||||0.2443|2-Sided|95.0|-2.4046|9.4023|||ANOVA|||Global Health Status /QoL. ANOVA included all post-baseline data (Months 3 through 21).|
1701574|NCT00967330|3128543|Superiority or Other||Least Square (LS) Mean Difference|2.1002||||0.4975|2-Sided|95.0|-3.9855|8.186|||ANOVA|||Physical Functioning. Analysis of variance (ANOVA) included all post-baseline data (Months 3 through 21).|
1701575|NCT00967330|3128545|Superiority or Other||Difference in response rate|-0.05||||0.38974|2-Sided|95.0|-0.18|0.07|||Fisher Exact|||Response rate based on participants with CR or PR at Month 6.|
1701576|NCT00967330|3128545|Superiority or Other||Difference in response rate|0.1||||0.18761|2-Sided|95.0|-0.02|0.23|||Fisher Exact|||Response rate based on participants with CR and PR at >4 weeks after RT.|
1701577|NCT00967330|3128545|Superiority or Other||Difference in response rate|0.25||||0.0021|2-Sided|95.0|0.12|0.38|||Fisher Exact|||Response rate based on participants with CR or PR at 4 weeks after RT.|
1701578|NCT00967330|3128545|Superiority or Other||Difference in response rate|0.0||||1|2-Sided|95.0|-0.08|0.08|||Fisher Exact|||The response rate based on participants with CR at Month 6.|
1701579|NCT00967330|3128545|Superiority or Other||Difference in response rate|0.09||||0.17923|2-Sided|95.0|0.0|0.17|||Fisher Exact|||The response rate based on participants with CR at >4 weeks after RT.|
1701580|NCT00967330|3128545|Superiority or Other||Difference in response rate|0.06||||0.34745|2-Sided|95.0|-0.02|0.14|||Fisher Exact|||Response rate based on participants with CR at 4 weeks after RT.|
1701581|NCT00967330|3128547|Superiority or Other||Hazard Ratio (HR)|0.963||||0.8283|2-Sided|95.0|0.684|1.354|||Chi-squared||||
1701582|NCT00967330|3128548|Superiority or Other||Hazard Ratio (HR)|0.588||||0.0012|2-Sided|95.0|0.423|0.817|||Chi-squared||||
1701583|NCT00967330|3128549|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1701584|NCT00967226|3128562|Superiority or Other||Mean Difference (Net)|0.06|Standard Deviation|0.05||0.77|||||||t-test, 2 sided|||intention to treat analysis|
1701585|NCT00966953|3128598|Superiority or Other|||||||0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1701586|NCT00966875|3128613|Superiority or Other|||||||0.105||||||P-value is for Week 12.|Fisher Exact||||
1701587|NCT00966875|3128613|Superiority or Other|||||||0.077||||||P-value is for Week 12.|Fisher Exact||||
1701588|NCT00966875|3128613|Superiority or Other|||||||0.393||||||P-value is for Week 12.|Fisher Exact||||
1701589|NCT00966875|3128613|Superiority or Other|||||||0.053||||||P-value is for Week 12.|Fisher Exact||||
1701590|NCT00966875|3128613|Superiority or Other|||||||0.03||||||P-value is for Week 12.|Fisher Exact||||
1701591|NCT00966875|3128613|Superiority or Other|||||||0.515||||||P-value is for Week 12.|Fisher Exact||||
1701592|NCT00966875|3128613|Superiority or Other|||||||0.538||||||P-value is for Week 12.|Fisher Exact||||
1701593|NCT00966875|3128615|Superiority or Other|||||||0.066||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701594|NCT00966875|3128615|Superiority or Other|||||||0.017||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701595|NCT00966875|3128615|Superiority or Other|||||||0.046||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701596|NCT00966875|3128615|Superiority or Other|||||||0.01||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701597|NCT00966875|3128615|Superiority or Other|||||||0.05||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701598|NCT00966875|3128615|Superiority or Other|||||||0.276||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701599|NCT00966875|3128615|Superiority or Other|||||||0.982||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701600|NCT00966875|3128617|Superiority or Other|||||||0.079||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701601|NCT00966875|3128617|Superiority or Other|||||||0.975||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701602|NCT00966875|3128617|Superiority or Other|||||||0.138||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701603|NCT00966875|3128617|Superiority or Other|||||||0.316||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701604|NCT00966875|3128617|Superiority or Other|||||||0.236||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701605|NCT00966875|3128617|Superiority or Other|||||||0.962||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701606|NCT00966875|3128617|Superiority or Other|||||||0.272||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701607|NCT00966875|3128619|Superiority or Other|||||||0.029||||||P-value is for Week 12.|ANCOVA||||
1701608|NCT00966875|3128619|Superiority or Other|||||||0.16||||||P-value is for Week 12.|ANCOVA||||
1701609|NCT00966875|3128619|Superiority or Other|||||||0.048||||||P-value is for Week 12.|ANCOVA||||
1701610|NCT00966875|3128619|Superiority or Other|||||||0.056||||||P-value is for Week 12.|ANCOVA||||
1701611|NCT00966875|3128619|Superiority or Other|||||||0.139||||||P-value is for Week 12.|ANCOVA||||
1701612|NCT00966875|3128619|Superiority or Other|||||||0.104||||||P-value is for Week 12.|ANCOVA||||
1701613|NCT00966875|3128619|Superiority or Other|||||||0.307||||||P-value is for Week 12.|ANCOVA||||
1701614|NCT00966875|3128621|Superiority or Other|||||||0.001||||||P-value is for Week 12.|Fisher Exact||||
1701615|NCT00966875|3128621|Superiority or Other|||||||0.006||||||P-value is for Week 12 LOCF.|Fisher Exact||||
1701616|NCT00966875|3128621|Superiority or Other|||||||0.002||||||P-value is for Week 12.|Fisher Exact||||
1701617|NCT00966875|3128621|Superiority or Other||||||<|0.001||||||P-value is for Week 12 LOCF.|Fisher Exact||||
1701618|NCT00966875|3128621|Superiority or Other||||||<|0.002||||||P-value is for Week 12 LOCF.|Fisher Exact||||
1701619|NCT00966875|3128621|Superiority or Other||||||<|0.076||||||P-value is for Week 12 LOCF.|Fisher Exact||||
1701620|NCT00966875|3128621|Superiority or Other||||||<|0.013||||||P-value is for Week 12 LOCF.|Fisher Exact||||
1701621|NCT00966875|3128623|Superiority or Other|||||||0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701626|NCT00966875|3128623|Superiority or Other||||||<|0.012||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701627|NCT00966875|3128623|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701628|NCT00966875|3128625|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701629|NCT00966875|3128625|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701630|NCT00966875|3128625|Superiority or Other||||||<|0.01||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701631|NCT00966875|3128625|Superiority or Other||||||<|0.013||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701632|NCT00966875|3128625|Superiority or Other||||||<|0.008||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701633|NCT00966875|3128625|Superiority or Other||||||<|0.131||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701634|NCT00966875|3128625|Superiority or Other||||||<|0.09||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701635|NCT00966875|3128627|Superiority or Other|||||||0.003||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701636|NCT00966875|3128627|Superiority or Other|||||||0.292||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701637|NCT00966875|3128627|Superiority or Other|||||||0.039||||||P-value is for Week 12..|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701638|NCT00966875|3128627|Superiority or Other|||||||0.331||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701639|NCT00966875|3128627|Superiority or Other|||||||0.03||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701640|NCT00966875|3128627|Superiority or Other|||||||0.865||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701641|NCT00966875|3128627|Superiority or Other|||||||0.778||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701642|NCT00966875|3128629|Superiority or Other|||||||0.005||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701643|NCT00966875|3128629|Superiority or Other|||||||0.365||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701644|NCT00966875|3128629|Superiority or Other|||||||0.055||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701645|NCT00966875|3128629|Superiority or Other|||||||0.042||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701646|NCT00966875|3128629|Superiority or Other|||||||0.006||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701647|NCT00966875|3128629|Superiority or Other|||||||0.315||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701648|NCT00966875|3128629|Superiority or Other|||||||0.247||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701649|NCT00966875|3128631|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701650|NCT00966875|3128631|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701651|NCT00966875|3128631|Superiority or Other||||||<|0.028||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701652|NCT00966875|3128631|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701653|NCT00966875|3128631|Superiority or Other||||||<|0.006||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701654|NCT00966875|3128631|Superiority or Other||||||<|0.023||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701655|NCT00966875|3128631|Superiority or Other||||||<|0.093||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701656|NCT00966875|3128633|Superiority or Other|||||||0.007||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701657|NCT00966875|3128633|Superiority or Other|||||||0.008||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701658|NCT00966875|3128633|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701659|NCT00966875|3128633|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701660|NCT00966875|3128633|Superiority or Other||||||<|0.004||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701661|NCT00966875|3128633|Superiority or Other||||||<|0.042||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701662|NCT00966875|3128633|Superiority or Other||||||<|0.017||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701663|NCT00966875|3128635|Superiority or Other|||||||0.112||||||P-value is for ACR70-NRI at Week 12.|Fisher Exact||||
1701664|NCT00966875|3128635|Superiority or Other|||||||0.696||||||P-value is for ACR70-NRI at Week 12.|Fisher Exact||||
1701665|NCT00966875|3128635|Superiority or Other|||||||0.039||||||P-value is for ACR70-NRI at Week 12.|Fisher Exact||||
1701666|NCT00966875|3128635|Superiority or Other|||||||0.199||||||P-value is for ACR70-NRI at Week 12.|Fisher Exact||||
1701667|NCT00966875|3128635|Superiority or Other|||||||0.039||||||P-value is for ACR70-NRI at Week 12.|Fisher Exact||||
1701668|NCT00966875|3128635|Superiority or Other|||||||0.033||||||P-value is for ACR70-NRI at Week 12.|Fisher Exact||||
1701669|NCT00966875|3128635|Superiority or Other|||||||0.388||||||P-value is for ACR70-NRI at Week 12.|Fisher Exact||||
1701670|NCT00966875|3128635|Superiority or Other|||||||0.102||||||P-value is for ACR50-NRI at Week 12.|Fisher Exact||||
1701671|NCT00966875|3128635|Superiority or Other|||||||0.039||||||P-value is for ACR50-NRI at Week 12.|Fisher Exact||||
1701672|NCT00966875|3128635|Superiority or Other|||||||0.026||||||P-value is for ACR50-NRI at Week 12.|Fisher Exact||||
1701681|NCT00966875|3128635|Superiority or Other|||||||0.001||||||P-value is for ACR20-NRI at Week 12.|Fisher Exact||||
1701682|NCT00966875|3128635|Superiority or Other|||||||0.306||||||P-value is for ACR20-NRI at Week 12.|Fisher Exact||||
1701683|NCT00966875|3128635|Superiority or Other|||||||0.227||||||P-value is for ACR20-NRI at Week 12.|Fisher Exact||||
1701684|NCT00966875|3128637|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701685|NCT00966875|3128637|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701686|NCT00966875|3128637|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701687|NCT00966875|3128637|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701688|NCT00966875|3128637|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701689|NCT00966875|3128637|Superiority or Other||||||<|0.004||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701690|NCT00966875|3128637|Superiority or Other||||||<|0.013||||||P-value is for Week 12.|ANCOVA|ANCOVA adjusted for treatment and baseline value.|||
1701691|NCT00966875|3128641|Superiority or Other|||||||0.047|||||||Fisher Exact||||
1701692|NCT00966875|3128641|Superiority or Other|||||||0.033|||||||Fisher Exact||||
1701693|NCT00966875|3128642|Superiority or Other|||||||0.031||||||A log transformed dose was used in the model.|Regression, Logistic||||
1701694|NCT00966719|3128652|Other||Risk Ratio (RR)|1.36||||0.6|2-Sided|95.0|0.58|3.15|||Fisher Exact||||
1701695|NCT00966719|3128653|Other||Risk Ratio (RR)|1.03||||0.77|2-Sided|95.0|0.83|1.27|||Fisher Exact||||
1701696|NCT00966719|3128654|Other||Risk Ratio (RR)|1.5||||0.09|2-Sided|95.0|0.95|2.38|||Fisher Exact||||
1701697|NCT00966719|3128655|Other||Risk Ratio (RR)|2.94||||0.32|2-Sided|95.0|0.32|27.3|||Fisher Exact||||
1701698|NCT00966719|3128656|Other||Risk Ratio (RR)|1.03||||0.78|2-Sided|95.0|0.85|1.26|||Fisher Exact||||
1701699|NCT00966719|3128657|Other||Risk Ratio (RR)|1.0||||1|2-Sided|95.0|0.91|1.1|||Fisher Exact||||
1701700|NCT00966719|3128658|Other||Risk Ratio (RR)|1.15||||1|2-Sided|95.0|0.44|3.02|||Fisher Exact||||
1701701|NCT00966719|3128659|Other||Risk Ratio (RR)|0.84||||0.4|2-Sided|95.0|0.56|1.24|||Fisher Exact||||
1701702|NCT00966550|3128663|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1701703|NCT00966433|3128669|Other||Mean Difference (Final Values)|-13.9||||0.0001|2-Sided|95.0|-18.88|-8.92|||t-test, 2 sided||||
1701704|NCT00966433|3128674|Other||Mean Difference (Final Values)|3.6||||0.0001|2-Sided|95.0|2.97|4.23|||t-test, 2 sided||||
1701705|NCT00966433|3128675|Other||Mean Difference (Final Values)|-8.2||||0.0051|2-Sided|95.0|-13.61|-2.79|||t-test, 2 sided||||
1701706|NCT00965718|3128733|Superiority or Other|||||||0.123||||||Global health status scores at baseline and final observation point were compared via a 2-sided t-test.|t-test, 2 sided||||
1701707|NCT00965562|3128737|Superiority or Other||Cohen's d effect size|0.32||||0.54|2-Sided||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 2 and 5 and changes in the placebo group between Visits 2 and 5, divided by the std dev in the placebo group at Visit 5||
1701708|NCT00965562|3128737|Superiority or Other||Cohen's d effect size|0.8||||0.04|2-Sided||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 2 and 5 and changes in the placebo group between Visits 2 and 5, divided by the std dev in the placebo group at Visit 5||
1701709|NCT00965562|3128737|Superiority or Other||Slope|-0.2||||0.54|2-Sided|95.0|-0.86|0.46|||Mixed Models Analysis||Slope represents average change in calcium group CGI Improvement scores as compared to placebo||
1701710|NCT00965562|3128737|Superiority or Other||Slope|-1.03||||0.04|2-Sided|95.0|-1.7|-0.35|||Mixed Models Analysis||Slope represents average change in fluoxetine group CGI Improvement scores as compared to placebo||
1701711|NCT00965562|3128738|Superiority or Other||Cohen's d effect size|0.18||||0.58|2-Sided||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5||
1701712|NCT00965562|3128738|Superiority or Other||Cohen's d effect size|2.08||||0.02|2-Sided||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5||
1701713|NCT00965562|3128738|Superiority or Other||Slope|0.06||||0.58|2-Sided|95.0|-0.16|0.28|||Mixed Models Analysis||Slope represents average change in calcium group DRSP scores as compared to placebo||
1701714|NCT00965562|3128738|Superiority or Other||Slope|-0.28||||0.02|2-Sided|95.0|-0.53|-0.04|||Mixed Models Analysis||Slope represents average change in fluoxetine group DRSP scores as compared to placebo||
1701715|NCT00965562|3128739|Superiority or Other||Cohen's d effect size|0.44||||0.36|2-Sided||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5||
1701716|NCT00965562|3128739|Superiority or Other||Cohen's d effect size|0.92||||0.07|2-Sided||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5||
1701717|NCT00965562|3128739|Superiority or Other||Slope|-0.17||||0.36|2-Sided|95.0|-0.54|0.2|||Mixed Models Analysis||Slope represents average change in calcium group CGI-S scores as compared to placebo||
1701718|NCT00965562|3128739|Superiority or Other||Slope|-0.35||||0.07|2-Sided|95.0|-0.73|0.03|||Mixed Models Analysis||Slope represents average change in fluoxetine group CGI-S scores as compared to placebo||
1701719|NCT00965562|3128740|Superiority or Other||Cohen's d effect size|0.37||||0.4|2-Sided||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5||
1701720|NCT00965562|3128740|Superiority or Other||Cohen's d effect size|1.06||||0.1|2-Sided||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5||
1701721|NCT00965562|3128740|Superiority or Other||Slope|-0.81||||0.4|2-Sided|95.0|-2.71|1.09|||Mixed Models Analysis||Slope represents average change in calcium group PMTS scores as compared to placebo||
1701722|NCT00965562|3128740|Superiority or Other||Slope|-1.63||||0.1|2-Sided|95.0|-3.6|0.34|||Mixed Models Analysis||Slope represents average change in fluoxetine group PMTS scores as compared to placebo||
1701723|NCT00965562|3128741|Superiority or Other||Cohen's d effect size|0.1||||0.94|2-Sided||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5||
1701724|NCT00965562|3128741|Superiority or Other||Cohen's d effect size|1.15||||0.07|2-Sided||||||Mixed Models Analysis||Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5||
1701725|NCT00965562|3128741|Superiority or Other||Slope|-0.1||||0.94|2-Sided|95.0|-2.85|2.65|||Mixed Models Analysis||Slope represents average change in calcium group IDS scores as compared to placebo||
1701726|NCT00965562|3128741|Superiority or Other||Slope|-2.63||||0.07|2-Sided|95.0|-5.51|0.24|||Mixed Models Analysis||Slope represents average change in fluoxetine group IDS score as compared to placebo||
1701727|NCT00965562|3128742|Superiority or Other|||||||0.04|||||||Chi-squared||||
1701728|NCT00965562|3128743|Superiority or Other|||||||0.005|||||||Chi-squared||||
1701729|NCT00965562|3128744|Superiority or Other|||||||0.09|||||||Chi-squared||||
1701730|NCT00965562|3128745|Superiority or Other|||||||0.06|||||||Chi-squared||||
1701731|NCT00965562|3128746|Superiority or Other|||||||0.05|||||||Chi-squared||||
1701732|NCT00965562|3128747|Superiority or Other|||||||0.15|||||||Chi-squared||||
1701733|NCT00965497|3128751|Superiority or Other||Mean Difference (Final Values)|95.0||||0.01|2-Sided|95.0|||||t-test, 2 sided|||There were 13 people that completed so there truly was no power to detect true differences; therefore only trends can be discussed.|
1701734|NCT00965458|3128756|Superiority or Other|||||||0.942||||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 104 mean HbA1C comparison|
1701735|NCT00965458|3128756|Superiority or Other|||||||0.746||||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 52 mean HbA1C comparison|
1701736|NCT00965458|3128757|Superiority or Other||||||<|0.001||||||P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups|Regression, Logistic|||Hypoglycemic Events Occurring from Week 52 to Week 104|
1701737|NCT00965458|3128757|Superiority or Other||||||<|0.001||||||P-value is from a poisson regression comparing the person-year adjusted event rates between the two treatment groups|Regression, Logistic|||Hypoglycemic Events Occurring from Baseline to Week 52|
1701738|NCT00965458|3128758|Superiority or Other|||||||0.002||||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 104 mean insulin use comparison|
1701739|NCT00965458|3128758|Superiority or Other|||||||0.02||||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change from baseline as the outcome variable|ANCOVA|||Week 52 mean insulin use comparison|
1701740|NCT00965458|3128759|Superiority or Other|||||||0.015||||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 104 AUC. Measuring range for C-peptide is 0.05-30 ng/mL|
1701741|NCT00965458|3128759|Superiority or Other|||||||0.065||||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 52 AUC. Measuring range for C-peptide is 0.05-30 ng/mL|
1701742|NCT00965458|3128760|Superiority or Other|||||||0.002||||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 104 AUC. Measuring range for C-peptide is 0.05-30 ng/mL|
1701743|NCT00965458|3128760|Superiority or Other|||||||0.019||||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome|ANCOVA|||Primary imputation method used for missing Week 52 AUC. Measuring range for C-peptide is 0.05-30 ng/mL|
1701744|NCT00965458|3128761|Superiority or Other|||||||0.065||||||P-value is for testing treatment effect using an analysis of covariance with baseline ln(AUC+1) as a covariate and change in ln(AUC+1) from baseline as the outcome variable.|ANCOVA|||Primary imputation method used for missing Month 12 AUC. Measuring range for C-peptide is 0.05-30 ng/mL.|
1701745|NCT00965250|3128809|Superiority or Other||||||<|0.0001|||||||Kaplan Meier||||
1701746|NCT00965250|3128810|Superiority or Other||||||<|0.0001|||||||Kaplan Meier||||
1701747|NCT00964886|3128842|Superiority or Other|||||||0.8|||||||ANCOVA|||This analysis compares outcomes for participants assigned at baseline to receive cognitive behavioral therapy or not to receive cognitive behavioral therapy (behavioral effect)|
1701748|NCT00964886|3128843|Superiority or Other|||||||0.6|||||||ANCOVA||||
1702090|NCT00958191|3129878|Superiority or Other|||||||0.0242|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 1 year|
1701749|NCT00964886|3128844|Superiority or Other|||||||0.84|||||||ANCOVA|Means are adjusted for baseline Roland and Morris scores.||In the intent-to-treat sample of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance (ANOVA) compared mean Roland and Morris scores at 12 weeks adjusted for mean baseline scores.|
1701750|NCT00964886|3128845|Superiority or Other|||||||0.7|||||||ANCOVA|||In an intent-to-treat analysis of all randomized participants assigned to experimental drug (desipramine) or active placebo (benztropine) an analysis of variance compared mean Descriptor Differential Scale scores at 12 weeks (or last observation carried forward) adjusted fro mean baseline score ( = ).|
1701751|NCT00964860|3128846|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.05||0.004|1-Sided|95.0||||a priori threshold for statistical significance = 0.05|ANCOVA||All treatment comparisons were 1-sided with the significance level set at 5%||
1701752|NCT00964860|3128847|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.05||0.001|1-Sided|95.0||||a priori threshold for statistical significance = 0.05|ANCOVA||All treatment comparisons were 1-sided with the significance level set at 5%. Units on the MGI Scale.||
1701753|NCT00964678|3128862|Superiority||||||>|0.05|||||||ANOVA||||
1701754|NCT00964678|3128863|Superiority||||||>|0.05||||||The threshold for statistical significance was p=0.05.|ANOVA||||
1701755|NCT00964678|3128864|Superiority|||||||0.028||||||The threshold for statistical significance was p=0.05.|ANOVA||||
1701756|NCT00964678|3128865|Superiority|||||||0.028||||||The threshold for statistical significance was p=0.05.|ANOVA||||
1701757|NCT00964496|3128869|Superiority or Other||Differences in proportions|0.464||||3.962e-05|2-Sided|95.0|0.28|0.649|||Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the cessation of bleeding.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the cessation of bleeding.~Comparisons were performed with the use of the chi-square test, Fisher’s exact test."|
1701758|NCT00964496|3128870|Superiority or Other||Mean Difference (Final Values)|1557.14|||<|0.01|2-Sided|95.0|1294.53|1819.76||P<0.05 was considered as statistical different, while P>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in total transfused red cell requirements at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in total transfused red cell requirements at 12 months.~Comparisons were performed with the use of the independent-samples t test."|
1701759|NCT00964496|3128871|Superiority or Other||Differences in proportions|-0.374||||0.00298881|2-Sided|95.0|-0.563|-0.185||P<0.05 was considered as statistical different, while P>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the participants dependent on blood transfusions.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the participants dependent on blood transfusions.~Comparisons were performed with the use of the chi-square test, Fisher’s exact test."|
1701760|NCT00964496|3128872|Superiority or Other||Mean Difference (Final Values)|4.4||||0.0002474|2-Sided|95.0|2.15|6.64||P<0.05 was considered as statistical different, while P>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in bleeding duration at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in bleeding duration at 12 months.~Comparisons were performed with the use of the independent-samples t test."|
1701761|NCT00964496|3128873|Superiority or Other||Mean Difference (Final Values)|7.95|||<|0.01|2-Sided|95.0|6.0|9.9||P<0.05 was considered as statistical different, while P>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in bleeding episodes at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in bleeding episodes at 12 months.~Comparisons were performed with the use of the independent-samples t test."|
1701762|NCT00964496|3128874|Superiority or Other||Mean Difference (Final Values)|-3.08|||<|0.001|2-Sided|95.0|-4.02|-2.13||P<0.05 was considered as statistical different, while P>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|t-test, 2 sided|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the change from baseline in hemoglobin level at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the change from baseline in hemoglobin level at 12 months.~Comparisons were performed with the use of the independent-samples t test."|
1701763|NCT00964496|3128875|Superiority or Other||Differences in proportions|0.677||||1.3e-07|2-Sided|95.0|0.547|0.807||P<0.05 was considered as statistical different, while P>0.05 was considered as no statistical significance between two groups. All reported P values are two-sided.|Fisher Exact|||"Null hypothesis (H0): Thalidomide 100 mg per day is equivalence to iron 400 mg per day with regard to the participants whose rebleeds decreased from baseline by ≥ 50% at 12 months.~Alternative hypothesis (Ha): Thalidomide 100 mg per day is non-equivalent to iron 400 mg per day with regard to the participants whose rebleeds decreased from baseline by ≥ 50% at 12 months.~Comparisons were performed with the use of the chi-square test, Fisher’s exact test."|
1701764|NCT00964431|3128877|Superiority or Other||Mean Difference (Net)|9.545|Standard Error of the Mean|1.8912|<|0.001|2-Sided|95.0|5.816|13.275|||ANCOVA||||
1701765|NCT00964366|3128880|Superiority or Other||||||>|0.05|||||||ANOVA||||
1701766|NCT00964366|3128881|Superiority or Other||||||>|0.05|||||||ANOVA||||
1701767|NCT00964366|3128882|Superiority or Other||||||<|0.05||||||Dapsone versus Clindamycin/BPO gel.|Dunn's Multiple Comparisons Test||||
1701768|NCT00964366|3128884|Superiority or Other||||||>|0.05|||||||Dunn's Multiple Comparisons Test||||
1702091|NCT00958191|3129878|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in SF-12 Phyiscal Component Score from preop to 5 year|
1701769|NCT00964119|3128958|Superiority or Other||||||<|0.05||||||P-value < .05 is the computed p-value for this measurement.|t-test, 2 sided|||PI and lead author left the institution before publishing data. Study has been closed and data files archived.|
1701770|NCT00963937|3128970|Superiority or Other||Percent Difference|-7.49||||0.345|2-Sided|95.0|-23.02|8.04||Multiplicity was not considered because the primary analysis included a single statistical comparison.|Chi-squared||Percent difference = sumatriptan pooled group minus the placebo group||
1701771|NCT00963807|3129015|Superiority or Other|||||||0.336|||||||t-test, 2 sided||||
1701772|NCT00963508|3129040|Superiority or Other|||||||0.0005|||||||t-test, 2 sided||||
1701773|NCT00963508|3129041|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1701774|NCT00963482|3129043|Superiority or Other||||||=|0||||||not adjusted for multiple comparisons due to only two groups p<.05, two-tailed|Chi-squared|||"H0: EG is equal in smoking quit rates compared to CG. H1: EG is superior in smoking quit rates compared to CG"|
1701775|NCT00962754|3129154|Non-Inferiority or Equivalence|non-inferiority since our hypothesis was that there would be no difference in outcome between the intervention and the control group.|Adjusted ratio of geometric means|1.0|||<|0.05|2-Sided|95.0|0.81|1.19||"log transformation of mean duration of hospitalization,difference between two groups expressed as ratio of geometric means for duration. 95% confidence intervals calculated using bootstrapping method.~correction by linear regression model"|t-test, 2 sided|||We calculated that 85 patients in each group would give a power in excess of 85% to detect a difference of two days or more in the geometric mean length of hospital stay with a two-sided significance level of 0.05.|
1701776|NCT00962585|3129246|Superiority or Other|||||||0.0381||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol groups combined versus Placebo: Change from Baseline at Week 4|||
1701777|NCT00962585|3129247|Superiority or Other|||||||0.7155|||||||Kruskal-Wallis|||All three S-equol treatment arms were aggregated and compared to placebo.|
1701778|NCT00962585|3129247|Superiority or Other|||||||0.7037||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4|||
1701779|NCT00962585|3129247|Superiority or Other|||||||0.26||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4|||
1701780|NCT00962585|3129247|Superiority or Other|||||||0.4352||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4|||
1701781|NCT00962585|3129248|Superiority or Other|||||||0.0097||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol groups combined versus Placebo: Change from Baseline at Week 4|||
1701782|NCT00962585|3129249|Superiority or Other|||||||0.0645|||||||Kruskal-Wallis|||All three S-equol treatment arms were aggregated and compared to placebo.|
1701783|NCT00962585|3129249|Superiority or Other|||||||0.0281||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4|||
1701784|NCT00962585|3129249|Superiority or Other|||||||0.0258||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance P <0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4|||
1701785|NCT00962585|3129249|Superiority or Other|||||||0.0475||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon Mann-Whitney test: S-equol treatment group versus Placebo: Percentage Change from Baseline at Week 4|||
1701786|NCT00962585|3129253|Superiority or Other||LS means difference|-22.74|||>|0.05|2-Sided|95.0|-67.44|21.96|||Pair-wise comparisons|||Week 4, Treatment Effect|
1701787|NCT00962585|3129253|Superiority or Other||LS means difference|7.8|||>|0.05|2-Sided|95.0|-36.7|52.29|||Pair-wise comparisons|||Week 4, Treatment Effect|
1701788|NCT00962585|3129253|Superiority or Other||LS means difference|22.12|||>|0.05|2-Sided|95.0|-23.56|67.8|||Pair-wise comparisons|||Week 4, Treatment Effect|
1701789|NCT00962585|3129253|Superiority or Other||LS means difference|-4.58|||>|0.05|2-Sided|95.0|-37.39|28.23|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701790|NCT00962585|3129253|Superiority or Other||LS means difference|3.61|||>|0.05|2-Sided|95.0|-29.12|36.34|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701791|NCT00962585|3129253|Superiority or Other||LS means difference|35.32|||>|0.05|2-Sided|95.0|1.75|68.9|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701792|NCT00962585|3129253|Superiority or Other||||||>|0.0681||||||P-value is adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Estradiol) = Baseline (Estradiol) + Treatment + Site + Weeks + Treatment x Weeks|||
1701793|NCT00962585|3129254|Superiority or Other||LS means difference|-2.88|||>|0.05|2-Sided|95.0|-9.05|3.28|||Pair-wise comparisons|||Week 4, Treatment Effect|
1701794|NCT00962585|3129254|Superiority or Other||LS means difference|-6.14|||>|0.05|2-Sided|95.0|-12.36|0.07|||Pair-wise comparisons|||Week 4, Treatment Effect|
1701795|NCT00962585|3129254|Superiority or Other||LS means difference|-0.31|||>|0.05|2-Sided|95.0|-6.73|6.11|||Pair-wise comparisons|||Week 4, Treatment Effect|
1701796|NCT00962585|3129254|Superiority or Other||LS means difference|-1.59|||>|0.05|2-Sided|95.0|-9.66|6.47|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701797|NCT00962585|3129254|Superiority or Other||LS means difference|-1.58|||>|0.05|2-Sided|95.0|-9.63|6.46|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701798|NCT00962585|3129254|Superiority or Other||LS means difference|-1.58|||>|0.05|2-Sided|95.0|-9.57|6.42|||Pair-wise comparisons|||Week 2, Treatment Effect|
1702101|NCT00958191|3129881|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in HHS from pre-op to 3 years|
1701799|NCT00962585|3129254|Superiority or Other||||||>|0.6375||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Vaginal Maturation Index) = Baseline (Vaginal Maturation Index) + Treatment + Site + Weeks + Treatment x Weeks||Vaginal maturation index = 0.2 x (% parabasal cells) + 0.6 x(% intermediate cells) + 1.0 x (% superficial cells)|
1701800|NCT00962585|3129255|Superiority or Other||LS means difference|-0.24|||>|0.05|2-Sided|95.0|-0.51|0.03|||Pair-wise comparisons|||Week 4, Treatment Effect|
1701801|NCT00962585|3129255|Superiority or Other||LS means difference|-0.13|||>|0.05|2-Sided|95.0|-0.4|0.14|||Pair-wise comparisons|||Week 4, Treatment Effect|
1701802|NCT00962585|3129255|Superiority or Other||LS means difference|-0.26|||>|0.05|2-Sided|95.0|-0.54|0.02|||Pair-wise comparisons|||Week 4, Treatment Effect|
1701803|NCT00962585|3129255|Superiority or Other||LS means difference|0.03|||>|0.05|2-Sided|95.0|-0.28|0.35|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701804|NCT00962585|3129255|Superiority or Other||LS means difference|-0.23|||>|0.05|2-Sided|95.0|-0.55|0.09|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701805|NCT00962585|3129255|Superiority or Other||LS means difference|-0.21|||>|0.05|2-Sided|95.0|-0.53|0.12|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701806|NCT00962585|3129255|Superiority or Other||||||>|0.2211||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05. Treatment effect averaged across Weeks 2 and 4.|Repeated measures ANCOVA|Mixed Model: (Vaginal pH) = Baseline (Vaginal pH) + Treatment + Site + Weeks + Treatment x Weeks|||
1701807|NCT00962585|3129256|Superiority or Other||LS means difference|-1.29|||>|0.05|2-Sided|95.0|-28.18|25.6|||Pair-wise comparisons|||Week 4, Treatment Effect|
1701808|NCT00962585|3129256|Superiority or Other||LS means difference|16.15|||>|0.05|2-Sided|95.0|-10.4|42.71|||Pair-wise comparisons|||Week 4, Treatment Effect|
1701809|NCT00962585|3129256|Superiority or Other||LS means difference|-1.69|||>|0.05|2-Sided|95.0|-28.68|25.3|||Pair-wise comparisons|||Week 4, Treatment Effect|
1701810|NCT00962585|3129256|Superiority or Other||LS means difference|-0.65|||>|0.05|2-Sided|95.0|-27.8|26.5|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701811|NCT00962585|3129256|Superiority or Other||LS means difference|8.73|||>|0.05|2-Sided|95.0|-18.19|35.65|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701812|NCT00962585|3129256|Superiority or Other||LS means difference|-16.14|||>|0.05|2-Sided|95.0|-43.29|11.01|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701813|NCT00962585|3129256|Superiority or Other||LS means difference|2.09|||>|0.05|2-Sided|95.0|-18.21|22.39|||Pair-wise comparisons|||Week 1, Treatment Effect|
1701814|NCT00962585|3129256|Superiority or Other||LS means difference|25.67|||<|0.05|2-Sided|95.0|5.64|45.69|||Pair-wise comparisons|||Week 1, Treatment Effect|
1701815|NCT00962585|3129256|Superiority or Other||LS means difference|-6.34|||>|0.05|2-Sided|95.0|-26.41|13.73|||Pair-wise comparisons|||Week 1, Treatment Effect|
1701816|NCT00962585|3129256|Superiority or Other||||||>|0.1609||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05. Treatment effect averaged across Weeks 1, 2 and 4.|Repeated measures ANCOVA|Mixed Model: Severity of VMS = Baseline (severity of VMS) + Treatment + Site + Weeks + Treatment x Weeks||Severity of VMS per week at each protocol visits = (Sum of scores of Mild, Moderate, Severe hot flushes)/(Current protocol visit date–Previous protocol visit date (days)) x 7, where severity of vasomotor symptoms are scored as: 1 = mild, 2 = moderate and 3 = severe.|
1701817|NCT00962585|3129257|Superiority or Other||LS means difference|0.91|||>|0.05|2-Sided|95.0|-10.77|12.58|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701818|NCT00962585|3129257|Superiority or Other||LS means difference|3.56|||>|0.05|2-Sided|95.0|-8.01|15.14|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701819|NCT00962585|3129257|Superiority or Other||LS means difference|-6.7|||>|0.05|2-Sided|95.0|-18.36|4.96|||Pair-wise comparisons|||Week 2, Treatment Effect|
1701820|NCT00962585|3129257|Superiority or Other||LS means difference|1.31|||>|0.05|2-Sided|95.0|-7.73|10.36|||Pair-wise comparisons|||Week 1, Treatment Effect|
1701821|NCT00962585|3129257|Superiority or Other||LS means difference|9.69|||<|0.05|2-Sided|95.0|0.79|18.6|||Pair-wise comparisons|||Week 1, Treatment Effect|
1701822|NCT00962585|3129257|Superiority or Other||LS means difference|-3.77|||>|0.05||95.0|-12.69|5.16|||Pair-wise comparisons|||Week 1, Treatment Effect|
1701823|NCT00962585|3129257|Superiority or Other||||||>|0.1217||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05. Treatment effect averaged across Weeks 1 and 2.|Repeated measures ANCOVA|"Mixed Model: MSVS = Baseline (MSVS) + Treatment + Site + Weeks + Treatment x Weeks~Difference Between Means: S-equol treatment group - Placebo"||# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7.|
1701824|NCT00962585|3129258|Superiority or Other||LS means difference|-1.63|||>|0.05|2-Sided|95.0|-13.41|10.15|||Pair-wise comparisons||||
1701825|NCT00962585|3129258|Superiority or Other||LS means difference|4.77|||>|0.05|2-Sided|95.0|-6.94|16.48|||Pair-wise comparisons||||
1701826|NCT00962585|3129258|Superiority or Other||LS means difference|-0.19|||>|0.05|2-Sided|95.0|-12.38|12.01|||Pair-wise comparisons||||
1701827|NCT00962585|3129258|Superiority or Other||||||>|0.7364||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05.|ANCOVA|"Model: Week 4 = Baseline (MSVS) + Treatment + Site~Difference Between Means: S-equol treatment group - Placebo"||"# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date–Previous protocol visit date (days)) x 7~1-week period = remaining days of the period since the last visit (i.e. period following first 7 days, as per CRF)"|
1701828|NCT00962585|3129259|Superiority or Other||LS means difference|0.94|||>|0.05|2-Sided|95.0|-10.16|12.04|||Pair-wise comparisons||||
1701829|NCT00962585|3129259|Superiority or Other||LS means difference|6.98|||>|0.05|2-Sided|95.0|-3.87|17.84|||Pair-wise comparisons||||
1701830|NCT00962585|3129259|Superiority or Other||LS means difference|1.13|||>|0.05|2-Sided|95.0|-10.06|12.32|||Pair-wise comparisons||||
1702092|NCT00958191|3129878|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in SF-12 Phyiscal Component Score from preop to 3 year|
1701831|NCT00962585|3129259|Superiority or Other||||||>|0.573||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was P <0.05.|ANCOVA|"Model (Analysis of covariance): Week 4 = Baseline (MSVS) + Treatment + Site~Difference Between Means: S-equol treatment group - Placebo"||"# of MSVS per week at each protocol visits = (# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)) x 7.~The ANCOVA procedure was used to test the following hypotheses:~H0: μ1 = μp versus HA: μ1 ≠ μp where μ1 and μp denote the mean frequency of MSVS (at Week 4 in case of primary efficacy endpoint), adjusted for Baseline MSVS values, in the treatment and placebo groups, respectively."|
1701832|NCT00962390|3129273|Superiority or Other||Mean Difference (Final Values)|0.1||||0.8185|2-Sided|95.0|-0.8|1.0||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect|
1701833|NCT00962390|3129273|Superiority or Other||Mean Difference (Final Values)|0.3||||0.4892|2-Sided|95.0|-0.5|1.1||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect|
1701834|NCT00962390|3129273|Superiority or Other||Mean Difference (Final Values)|0.3||||0.4678|2-Sided|95.0|-0.5|1.1||Statistical testing was 2-sided and the 5% significant level was used.|ANCOVA|The ANCOVA included Baseline as covariate and factors for treatment and site.|S-equol treatment group minus placebo group.|Week 4, Treatment Effect|
1701835|NCT00962104|3129279|Superiority or Other||Least Squares Mean Difference|-0.05||||0.87|2-Sided|95.0|-0.59|0.5||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA||||
1701836|NCT00962104|3129280|Superiority or Other||Least Squares Mean Difference|-0.05||||0.869|2-Sided|95.0|-0.71|0.6||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA||||
1701837|NCT00962104|3129281|Superiority or Other||||||<|0.001||||||Statistical significance was assessed using an analysis of variance (ANOVA) with term for treatment and country.|ANOVA||||
1701838|NCT00962104|3129282|Superiority or Other||Least Squares Mean Difference|-0.47|||<|0.001|2-Sided|95.0|-0.67|-0.27||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA||||
1701839|NCT00962104|3129283|Superiority or Other||Least Squares Mean Difference|-3.55||||0.153|2-Sided|95.0|-8.43|1.32||This is the p-value for the Raw Global Executive Composite Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA||||
1701840|NCT00962104|3129283|Superiority or Other||Least Squares Mean Difference|-1.62||||0.272|2-Sided|95.0|-4.52|1.28||This is the p-value for the Raw MI Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA||||
1701841|NCT00962104|3129283|Superiority or Other||Least Squares Mean Difference|-1.93||||0.092|2-Sided|95.0|-4.18|0.32||This is the p-value for the Raw Behavioral Regulation Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA||||
1701842|NCT00962104|3129284|Superiority or Other||Least Squares Mean Difference|-9.76|||<|0.001|2-Sided|95.0|-14.75|-4.78||This is the p-value for the Global Executive Composite Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA||||
1701843|NCT00962104|3129284|Superiority or Other||Least Squares Mean Difference|-6.29|||<|0.001|2-Sided|95.0|-9.28|-3.31||This is the p-value for the Raw MI score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA||||
1701844|NCT00962104|3129284|Superiority or Other||Least Squares Mean Difference|-3.59|||<|0.001|2-Sided|95.0|-5.73|-1.45||This is the p-value for the Raw Behavioral Regulation Index score. Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline value.|ANCOVA||||
1701845|NCT00962104|3129285|Superiority or Other||Least Squares Mean Difference|-6.18|||<|0.001|2-Sided|95.0|-8.21|-4.14|||Mixed Models Analysis||||
1701846|NCT00962104|3129286|Superiority or Other||Least Squares Mean Difference|-6.18|||<|0.001|2-Sided|95.0|-8.13|-4.22|||Mixed Models Analysis||||
1701847|NCT00962104|3129287|Superiority or Other||Least Squares Mean Difference|-1.82||||0.289|2-Sided|95.0|-5.2|1.56||Second gated secondary outcome measure. A gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 QoL measures. Treatments were compared stepwise until an outcome failed to be significant (p>0.05).|ANCOVA|Least Squares Mean difference between 2 treatment groups from Type III sum of squares analysis of covariance model:Change=treatment+country+baseline.|||
1701848|NCT00962104|3129288|Superiority or Other||Slope|4.76|||<|0.001|2-Sided|95.0|1.97|7.56||First gated secondary outcome measure. A gatekeeper strategy (Westfall and Krishen 2001) controlled experiment-wise type I error for 2 QoL measures. Treatments were compared stepwise until an outcome failed to be significant (p>0.05).|ANCOVA|Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline AAQoL total score.|||
1701849|NCT00962104|3129289|Superiority or Other||Least Squares Mean Difference|-5.78|||<|0.001|2-Sided|95.0|-7.66|-3.91||Statistical significance was assessed using an analysis of covariance (ANCOVA) with term for treatment, country, and baseline CAARS-Inv:SV 18-Item Total ADHD Symptom score .|ANCOVA||||
1701850|NCT00962091|3129294|Superiority or Other||Geometric mean ratio|0.94|||||2-Sided|90.0|0.68|1.32|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUC values (difference=Fed–Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.||
1701851|NCT00962091|3129295|Superiority or Other||Geometric mean ratio|1.04|||||2-Sided|90.0|0.8|1.34|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUClast values (difference=Fed–Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.||
1702093|NCT00958191|3129878|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in SF-12 Phyiscal Component Score from preop to 1 year|
1701852|NCT00962091|3129296|Superiority or Other||Geometric mean ratio|0.84|||||2-Sided|90.0|0.66|1.06|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 Cmax values (difference=Fed–Fasted). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.||
1701853|NCT00962091|3129302|Superiority or Other||Geometric mean ratio|1.38|||||2-Sided|90.0|1.08|1.78|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 AUClast values (difference=OS–PIC). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.||
1701854|NCT00962091|3129303|Superiority or Other||Geometric mean ratio|1.9|||||2-Sided|90.0|1.52|2.37|||||The CIs are calculated for the difference in the LS means of the ln-transformed Day 1 Cmax values (difference=OS–PIC). Antilogs of the confidence limits for the difference are taken to construct the CIs for the ratio of the geometric means.||
1701855|NCT00962013|3129312|Superiority or Other||||||<|0.0001|||||||Exact Binomial|||Post-surgery femoral stem crack/fracture rate compared to 21% (pre-specified in protocol based on literature rates) Femoral subsidence rate compared to 18% (pre-specified in protocol based on literature rates)|
1701856|NCT00962013|3129314|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from SF-36 Role-Physical pre-op score to 2 and 5 year scores|
1701857|NCT00962013|3129315|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from HHS pre-op to HHS 5 year|
1701858|NCT00962013|3129317|Non-Inferiority or Equivalence|non-inferiority margin is 7%||||||0.0136|||||||Exact Binomial|||This revision study will demonstrate a 5-year survivorship of the Restoration Modular system not seven percent worse than an expected 95% survival rate using a lower 95% one-sided confidence bound.|
1701859|NCT00962000|3129318|Non-Inferiority or Equivalence|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|0.035|Standard Error of the Mean|0.03103||||95.0|-0.029|0.099||||||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.|
1701860|NCT00962000|3129319|Non-Inferiority or Equivalence|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|-0.014|Standard Error of the Mean|0.01849|||2-Sided|95.0|-0.051|0.023||||||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.|
1701861|NCT00962000|3129320|Non-Inferiority or Equivalence|The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate.|Mean Difference (Final Values)|-0.024|Standard Error of the Mean|0.02217|||2-Sided|95.0|-0.064|0.024||||||Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.|
1701862|NCT00961805|3129327|Superiority or Other|||||||0.009||||||Differences in the behavior of the groups over time.|ANOVA||||
1701863|NCT00961805|3129328|Superiority or Other|||||||0.136||||||Differences in the behavior of the groups over time.|ANOVA||||
1701864|NCT00961805|3129329|Superiority or Other|||||||0.021||||||Differences in the behavior of the groups over time.|ANOVA||||
1701865|NCT00961805|3129330|Superiority or Other|||||||0.003||||||Differences in the behavior of the groups over time.|ANOVA||||
1701866|NCT00961805|3129331|Superiority or Other|||||||0.055||||||Differences in the behavior of the groups over time.|ANOVA||||
1701867|NCT00961805|3129332|Superiority or Other|||||||0.082||||||Differences in the behavior of the groups over time.|ANOVA||||
1701868|NCT00961805|3129333|Superiority or Other|||||||0.58||||||Differences in the behavior of the groups over time.|ANOVA||||
1701869|NCT00961805|3129334|Superiority or Other||||||<|0.001||||||Differences in the behavior of the groups over time.|ANOVA||||
1701870|NCT00961805|3129335|Superiority or Other|||||||0.131||||||Differences in the behavior of the groups over time.|ANOVA||||
1701871|NCT00961805|3129336|Superiority or Other|||||||0.146||||||Differences in the behavior of the groups over time.|ANOVA||||
1701872|NCT00961805|3129337|Superiority or Other||||||<|0.003||||||Differences in the behavior of the groups over time.|ANOVA||||
1701873|NCT00961805|3129338|Superiority or Other||||||<|0.001||||||Differences in the behavior of the groups over time.|ANOVA||||
1701874|NCT00961805|3129339|Superiority or Other||||||<|0.001||||||Differences in the behavior of the groups over time.|ANOVA|||"Sample size was calculated by visual analogue scale for pain (alpha error of 5%, beta error of 20% and standard deviation of 2). The sample was determined to contain 30 patients in each group. Ten additional patients were added to compensate possible losses.~Analysis was intention to treat using the LOCF technique."|
1701875|NCT00961662|3129345|Superiority or Other||Mean Difference (Net)|0.5|Standard Deviation|1.0|<|0.05|2-Sided|95.0|||||ANCOVA|||The HbA1c percent change at each study visit was calculated and then categorized as a binary response (i.e., responders and non-responders) for each subject based on the breakpoint to be used in the endpoint. Inferential statistics were prepared to compare the differences across the three treatments a using logistic regression model with the dose group and the HbA1c stratum included in the mode|
1701876|NCT00961636|3129348|Superiority or Other||||||<|0.001||||||The closed ordered testing procedure was applied to the efficacy hypotheses. If statistical significance was achieved for the primary hypothesis, then the secondary hypothesis was tested. All tests were performed at significance level 0.05.|Unconditional Miettinen and Nurminen||||
1702094|NCT00958191|3129879|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 5 years|
1701877|NCT00961636|3129349|Superiority or Other||||||<|0.001||||||The closed ordered testing procedure was applied to the efficacy hypotheses. If statistical significance was achieved for the primary hypothesis, then the secondary hypothesis was tested. All tests were performed at significance level 0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test was stratified by country|||
1701878|NCT00961532|3129352|Superiority or Other|||||||0.014|||||||t-test, 2 sided|||We tested the hypothesis that there would be a change from baseline to 60 minutes after the start of the desmopressin (DDAVP) infusion.|
1701879|NCT00961441|3129356|Superiority or Other||Point estimate for ratio|0.9914|||||2-Sided|90.0|0.811|1.2118||||||An ANOVA for log-transformed values has been used as the basis for calculation of point estimates and Confidence Intervals (CIs).|
1701880|NCT00961441|3129357|Superiority or Other||Point estimate for ratio|1.0271|||||2-Sided|90.0|0.8817|1.1964||||||An ANOVA for log-transformed values has been used as the basis for calculation of point estimates and Confidence Intervals (CIs).|
1701881|NCT00961415|3129361|Superiority or Other||Hazard Ratio (HR)|0.52|||<|0.001|2-Sided|95.0|0.38|0.7|||Log Rank||||
1701882|NCT00961415|3129362|Superiority or Other||Hazard Ratio (HR)|0.53||||0.006|2-Sided|95.0|0.34|0.84|||Log Rank||||
1701883|NCT00961415|3129364|Superiority or Other||Hazard Ratio (HR)|0.75||||0.23|2-Sided|95.0|0.47|1.2|||Log Rank||||
1701884|NCT00961415|3129365|Superiority or Other||Hazard Ratio (HR)|0.5|||<|0.001|2-Sided|95.0|0.37|0.69|||Log Rank||||
1701885|NCT00961350|3129370|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO and by baseline heartburn severity at randomization.||The proportion of subjects who had no heartburn at 6 months (regardless of the presence or absence of heartburn at baseline) was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|
1701886|NCT00961350|3129371|Superiority or Other|||||||0.002|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects discontinuing from the study due to NSAID-associated upper GI adverse events was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|
1701887|NCT00961350|3129372|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects with Treatment Success was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|
1701888|NCT00961350|3129373|Superiority or Other|||||||0.002|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects developing gastric ulcers and/or duodenal ulcers at 6 months was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|
1701889|NCT00961350|3129374|Superiority or Other||Proportions|3.8||||0.02||95.0|1.8|6.8|||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|The proportion is from the PA32540 treatment group.|The primary efficacy endpoint was the proportion of subjects with gastric ulcers throughout 6 months of treatment. The primary endpoint was analyzed with the CMH test stratified by NSAID use (COX-2/Other NSAID/No) at randomization. A sample size of 250 subjects/treatment would provide 86% power to detect the difference of 8% between EC aspirin 325 mg (13%) and PA32540 (5%) with a 2-sided significance of 5%; and, provides adequate power to test the key secondary endpoints in sequential order.|
1701890|NCT00960934|3129445|Superiority or Other||LS Mean Difference in Change From BL|4.02||||0.397|2-Sided|95.0|-5.31|13.36||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701891|NCT00960934|3129445|Superiority or Other||LS Mean Difference in Change From BL|12.87||||0.02|2-Sided|95.0|1.73|24.06||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701892|NCT00960934|3129445|Superiority or Other||LS Mean Difference in Change From BL|24.81|||<|0.001|2-Sided|95.0|12.39|37.33||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701893|NCT00960934|3129445|Superiority or Other||LS Mean Difference in Change From BL|41.41|||<|0.001|2-Sided|95.0|27.36|55.65||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701894|NCT00960934|3129445|Superiority or Other||LS Mean Difference in Change From BL|53.05|||<|0.001|2-Sided|95.0|37.83|68.53||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701895|NCT00960934|3129446|Superiority or Other||LS Mean Difference in Change From BL|8.39||||0.265|2-Sided|95.0|-3.4|20.21||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis||||
1701896|NCT00960934|3129446|Superiority or Other||LS Mean Difference in Change From BL|8.59||||0.265|2-Sided|95.0|-4.81|22.05||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis||||
1701897|NCT00960934|3129446|Superiority or Other||LS Mean Difference in Change From BL|20.68||||0.003|2-Sided|95.0|5.72|35.78||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis||||
1701898|NCT00960934|3129446|Superiority or Other||LS Mean Difference in Change From BL|39.66|||<|0.001|2-Sided|95.0|22.44|57.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis||||
1702095|NCT00958191|3129879|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 3 years|
1701899|NCT00960934|3129446|Superiority or Other||LS Mean Difference in Change From BL|56.77|||<|0.001|2-Sided|95.0|37.62|76.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis||||
1701900|NCT00960934|3129447|Superiority or Other||LS Mean Difference in Change From BL|5.46||||0.283|2-Sided|95.0|-3.39|14.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701901|NCT00960934|3129447|Superiority or Other||LS Mean Difference in Change From BL|6.31||||0.283|2-Sided|95.0|-3.81|16.45||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701902|NCT00960934|3129447|Superiority or Other||LS Mean Difference in Change From BL|10.45||||0.061|2-Sided|95.0|-0.37|21.3||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701903|NCT00960934|3129447|Superiority or Other||LS Mean Difference in Change From BL|23.38|||<|0.001|2-Sided|95.0|11.02|35.82||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701904|NCT00960934|3129447|Superiority or Other||LS Mean Difference in Change From BL|19.19|||<|0.001|2-Sided|95.0|7.42|31.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701905|NCT00960934|3129448|Superiority or Other||LS Mean Difference in Change From BL|-0.5||||0.937|2-Sided|95.0|-12.92|11.92||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis||||
1701906|NCT00960934|3129448|Superiority or Other||LS Mean Difference in Change From BL|9.02||||0.307|2-Sided|95.0|-5.85|23.95||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis||||
1701907|NCT00960934|3129448|Superiority or Other||LS Mean Difference in Change From BL|9.97||||0.307|2-Sided|95.0|-5.69|25.7||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis||||
1701908|NCT00960934|3129448|Superiority or Other||LS Mean Difference in Change From BL|20.57||||0.014|2-Sided|95.0|3.28|38.02||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis||||
1701909|NCT00960934|3129448|Superiority or Other||LS Mean Difference in Change From BL|34.26|||<|0.001|2-Sided|95.0|15.27|53.56||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis||||
1701910|NCT00960934|3129449|Superiority or Other||LS Mean Difference in Change From BL|5.72||||0.579||95.0|-8.62|20.1||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701911|NCT00960934|3129449|Superiority or Other||LS Mean Difference in Change From BL|8.44||||0.434|2-Sided|95.0|-7.09|24.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701912|NCT00960934|3129449|Superiority or Other||LS Mean Difference in Change From BL|-2.83||||0.642|2-Sided|95.0|-14.81|9.14||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701913|NCT00960934|3129449|Superiority or Other||LS Mean Difference in Change From BL|10.08||||0.357|2-Sided|95.0|-6.16|26.41||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701914|NCT00960934|3129449|Superiority or Other||LS Mean Difference in Change From BL|19.77||||0.02|2-Sided|95.0|2.26|37.46||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701915|NCT00960934|3129450|Superiority or Other||LS Mean Difference in Change From BL|0.51||||0.979|2-Sided|95.0|-2.34|3.37||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701916|NCT00960934|3129450|Superiority or Other||LS Mean Difference in Change From BL|-0.49||||0.979|2-Sided|95.0|-3.27|2.3||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701917|NCT00960934|3129450|Superiority or Other||LS Mean Difference in Change From BL|0.4||||0.979|2-Sided|95.0|-2.18|2.98||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701918|NCT00960934|3129450|Superiority or Other||LS Mean Difference in Change From BL|1.92||||0.363|2-Sided|95.0|-1.1|4.95||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1702096|NCT00958191|3129879|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in Harris Hip ROM score from pre-op to 1 year|
1701919|NCT00960934|3129450|Superiority or Other||LS Mean Difference in Change From BL|-0.37||||0.979|2-Sided|95.0|-2.73|1.99||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701920|NCT00960934|3129451|Superiority or Other||LS Mean Difference in Change From BL|-0.04||||0.997|2-Sided|95.0|-1.51|1.43||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701921|NCT00960934|3129451|Superiority or Other||LS Mean Difference in Change From BL|0.03||||0.997|2-Sided|95.0|-1.29|1.35||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701922|NCT00960934|3129451|Superiority or Other||LS Mean Difference in Change From BL|-0.52||||0.901|2-Sided|95.0|-2.17|1.13||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701923|NCT00960934|3129451|Superiority or Other||LS Mean Difference in Change From BL|-0.51||||0.901|2-Sided|95.0|-2.18|1.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701924|NCT00960934|3129451|Superiority or Other||LS Mean Difference in Change From BL|-0.43||||0.901|2-Sided|95.0|-2.03|1.17||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701925|NCT00960934|3129452|Superiority or Other||LS Mean Difference in Change From BL|-0.25||||0.961|2-Sided|95.0|-1.77|1.26||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701926|NCT00960934|3129452|Superiority or Other||LS Mean Difference in Change From BL|-0.11||||0.961|2-Sided|95.0|-1.45|1.24||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701927|NCT00960934|3129452|Superiority or Other||LS Mean Difference in Change From BL|0.66||||0.778|2-Sided|95.0|-1.01|2.33||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701928|NCT00960934|3129452|Superiority or Other||LS Mean Difference in Change From BL|-0.28||||0.961|2-Sided|95.0|-1.9|1.34||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701929|NCT00960934|3129452|Superiority or Other||LS Mean Difference in Change From BL|-0.35||||0.961|2-Sided|95.0|-2.0|1.31||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701930|NCT00960934|3129453|Superiority or Other||LS Mean Difference in Change From BL|0.16||||0.976|2-Sided|95.0|-0.76|1.08||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701931|NCT00960934|3129453|Superiority or Other||LS Mean Difference in Change From BL|0.02||||0.982|2-Sided|95.0|-0.75|0.78||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701932|NCT00960934|3129453|Superiority or Other||LS Mean Difference in Change From BL|0.53||||0.489|2-Sided|95.0|-0.43|1.49||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701933|NCT00960934|3129453|Superiority or Other||LS Mean Difference in Change From BL|-0.06||||0.982|2-Sided|95.0|-0.93|0.8||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701934|NCT00960934|3129453|Superiority or Other||LS Mean Difference in Change From BL|-0.17||||0.976|2-Sided|95.0|-1.12|0.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701935|NCT00960934|3129454|Superiority or Other||LS Mean Difference in Change From BL|-0.08||||0.999|2-Sided|95.0|-2.1|1.94||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701936|NCT00960934|3129454|Superiority or Other||LS Mean Difference in Change From BL|0.45||||0.959|2-Sided|95.0|-1.67|2.57||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701937|NCT00960934|3129454|Superiority or Other||LS Mean Difference in Change From BL|0.05||||0.999|2-Sided|95.0|-1.84|1.93||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701938|NCT00960934|3129454|Superiority or Other||LS Mean Difference in Change From BL|-0.01||||0.999|2-Sided|95.0|-1.69|1.68||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1702097|NCT00958191|3129880|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 5 years|
1701939|NCT00960934|3129454|Superiority or Other||LS Mean Difference in Change From BL|0.6||||0.933|2-Sided|95.0|-1.56|2.77||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701940|NCT00960934|3129455|Superiority or Other||LS Mean Difference in Change From BL|1.27||||0.287|2-Sided|95.0|-0.58|3.12||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701941|NCT00960934|3129455|Superiority or Other||LS Mean Difference in Change From BL|-0.48||||0.855|2-Sided|95.0|-2.23|1.27||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701942|NCT00960934|3129455|Superiority or Other||LS Mean Difference in Change From BL|0.16||||0.964|2-Sided|95.0|-1.27|1.59||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701943|NCT00960934|3129455|Superiority or Other||LS Mean Difference in Change From BL|-0.16||||0.964|2-Sided|95.0|-1.79|1.47||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701944|NCT00960934|3129455|Superiority or Other||LS Mean Difference in Change From BL|0.58||||0.849|2-Sided|95.0|-1.22|2.37||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701945|NCT00960934|3129456|Superiority or Other||LS Mean Difference in Change From BL|-0.28||||0.959|2-Sided|95.0|-1.6|1.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701946|NCT00960934|3129456|Superiority or Other||LS Mean Difference in Change From BL|-0.41||||0.915|2-Sided|95.0|-1.78|0.97||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701947|NCT00960934|3129456|Superiority or Other||LS Mean Difference in Change From BL|0.24||||0.959|2-Sided|95.0|-0.95|1.42||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701948|NCT00960934|3129456|Superiority or Other||LS Mean Difference in Change From BL|-0.02||||0.971|2-Sided|95.0|-1.08|1.04||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701949|NCT00960934|3129456|Superiority or Other||LS Mean Difference in Change From BL|0.24||||0.959|2-Sided|95.0|-1.03|1.51||The Type-I error rate over the multiple treatment dose comparisons were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701950|NCT00960934|3129458|Superiority or Other||Mean Difference (Final Values)|1.6||||0.321|2-Sided|95.0|-4.3|8.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701951|NCT00960934|3129458|Superiority or Other||Mean Difference (Final Values)|1.6||||0.313|2-Sided|95.0|-4.2|8.6|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701952|NCT00960934|3129458|Superiority or Other||Mean Difference (Final Values)|0.0|||>|0.999|2-Sided|95.0|-5.8|5.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701953|NCT00960934|3129458|Superiority or Other||Mean Difference (Final Values)|0.0|||>|0.999|2-Sided|95.0|-5.8|5.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701954|NCT00960934|3129458|Superiority or Other||Mean Difference (Final Values)|0.0|||>|0.999|2-Sided|95.0|-5.8|5.8|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701955|NCT00960934|3129459|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.313|2-Sided|95.0|-8.5|4.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1702012|NCT00959660|3129675|Superiority|||||||0.25||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Non-Bone Lean Mass|
1701956|NCT00960934|3129459|Superiority or Other||Mean Difference (Final Values)|8.1||||0.05|2-Sided|95.0|0.0|18.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701957|NCT00960934|3129459|Superiority or Other||Mean Difference (Final Values)|17.2||||0.001|2-Sided|95.0|7.7|28.7|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701958|NCT00960934|3129459|Superiority or Other||Mean Difference (Final Values)|35.9|||<|0.001|2-Sided|95.0|24.1|48.5|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701959|NCT00960934|3129459|Superiority or Other||Mean Difference (Final Values)|47.6|||<|0.001|2-Sided|95.0|34.9|60.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701960|NCT00960934|3129460|Superiority or Other||Mean Difference (Final Values)|4.6||||0.254|2-Sided|95.0|-4.1|14.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701961|NCT00960934|3129460|Superiority or Other||Mean Difference (Final Values)|29.1|||<|0.001|2-Sided|95.0|17.0|42.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701962|NCT00960934|3129460|Superiority or Other||Mean Difference (Final Values)|29.6|||<|0.001|2-Sided|95.0|17.6|42.4|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701963|NCT00960934|3129460|Superiority or Other||Mean Difference (Final Values)|53.1|||<|0.001|2-Sided|95.0|39.6|65.2|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701964|NCT00960934|3129460|Superiority or Other||Mean Difference (Final Values)|69.8|||<|0.001||95.0|56.5|80.0|||Miettinen and Nurminen Method|||The Miettinen and Nurminen Method was used to estimate the treatment differences between the active dose group and the placebo group by comparing the percentage of participants in the active dose group with the event vs. the percentage of participants in the placebo group with the event. An associated p-value and 95% confidence interval were calculated for this difference.|
1701965|NCT00960934|3129461|Superiority or Other||LS Mean Difference in Change From BL|0.16||||0.823|2-Sided|95.0|-1.17|1.5||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701966|NCT00960934|3129461|Superiority or Other||LS Mean Difference in Change From BL|0.93||||0.457|2-Sided|95.0|-0.75|2.61||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701967|NCT00960934|3129461|Superiority or Other||LS Mean Difference in Change From BL|0.35||||0.823|2-Sided|95.0|-1.14|1.84||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701968|NCT00960934|3129461|Superiority or Other||LS Mean Difference in Change From BL|1.12||||0.333|2-Sided|95.0|-0.6|2.83||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701969|NCT00960934|3129461|Superiority or Other||LS Mean Difference in Change From BL|0.56||||0.749|2-Sided|95.0|-1.04|2.16||The Type-I error rate over the multiple treatment dose comparisons for the areal BMD at lumbar spine endpoint were controlled by step-down Dunnett’s test at the primary time point of Month 6, at an alpha level of 0.05, two-sided.|Longitudinal Data Analysis Model||||
1701970|NCT00960869|3129462|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO and by baseline heartburn severity at randomization.||The proportion of subjects who had no heartburn at 6 months (regardless of the presence or absence of heartburn at baseline) was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|
1702013|NCT00959660|3129675|Superiority||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Non-Bone Lean Mass|
1701971|NCT00960869|3129463|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects discontinuing from the study due to NSAID-associated upper GI adverse events was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|
1701972|NCT00960869|3129464|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects with Treatment Success was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|
1701973|NCT00960869|3129465|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.||The cumulative proportion of subjects developing gastric ulcers and/or duodenal ulcers at 6 months was analyzed using the CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|
1701974|NCT00960869|3129466|Superiority or Other||proportions|2.7||||0.005|2-Sided|95.0|1.1|5.5|||Cochran-Mantel-Haenszel|CMH test stratified by NSAID use=COX-2, other NSAID, or NSAID use=NO at randomization.|The proportion is from the PA32540 treatment group.|The primary efficacy endpoint was the proportion of subjects with gastric ulcers throughout 6 months of treatment. The primary endpoint was analyzed with the CMH test stratified by NSAID use (COX-2/Other NSAID/No) at randomization. A sample size of 250 subjects/treatment would provide 86% power to detect the difference of 8% between EC aspirin 325 mg (13%) and PA32540 (5%) with a 2-sided significance of 5%; and, provides adequate power to test the key secondary endpoints in sequential order.|
1701975|NCT00960843|3129470|Superiority or Other|||||||0.0193|||||||t-test, 2 sided||||
1701976|NCT00960843|3129471|Superiority or Other|||||||0.0225|||||||t-test, 2 sided||||
1701977|NCT00960843|3129472|Superiority or Other|||||||0.052|||||||t-test, 2 sided|||Null hypothesis was no difference between arms. Original power calculation specified 24 per group and this was achieved under initial randomization. However, due to failure to follow protocol specified adjustment criteria, pressure and weight data from one site had to be excluded.|
1701978|NCT00960661|3129490|Non-Inferiority or Equivalence|Non inferiority was concluded if the upper limit of the 95% confidence interval (CI) for the treatment contrast (BET minus BBT) at week 30 was less than the non inferiority margin.|Mean Difference (Final Values)|-0.04||||0.6273|2-Sided|95.0|-0.18|0.11||The primary mixed-model repeated measures (MMRM) model included baseline HbA1c as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.|Mixed model repeated measures|||The primary objective is to test the hypothesis that BET is non inferior to BBT with respect to change in HbA1c from baseline to Week 30.|
1701979|NCT00960622|3129491|Superiority or Other||Mean Difference (Net)|0.6|Standard Deviation|8.5|<|0.05|2-Sided|95.0|-6.3|11.3|||t-test, 2 sided|||"Paired t-tests for inter-group differences between baseline and end-of-study measurements.Regression analysis, physiological correlates of statistically significant between-group changes.~P<0.05 chosen for statistical significance"|
1701980|NCT00960440|3129543|Superiority or Other||Percentage Difference|5.05|Standard Error of the Mean|2.57||0.0496|2-Sided|95.0|0.0|10.1||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.|
1701981|NCT00960440|3129543|Superiority or Other||Percentage Difference|9.53|Standard Error of the Mean|3.05||0.0017|2-Sided|95.0|3.54|15.51||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.|
1701982|NCT00960440|3129544|Superiority or Other||LS Mean Difference|-0.25|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.36|-0.15||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.|
1701983|NCT00960440|3129544|Superiority or Other||LS Mean Difference|-0.28|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.38|-0.17||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.|
1701984|NCT00960440|3129545|Superiority or Other||Percentage Difference|17.23|Standard Error of the Mean|5.7||0.0024|2-Sided|95.0|6.06|28.41||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.|
1701985|NCT00960440|3129545|Superiority or Other||Percentage Difference|23.69|Standard Error of the Mean|5.73|<|0.0001|2-Sided|95.0|12.45|34.92||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.|
1702014|NCT00959660|3129675|Superiority||||||<|0.001||||||Main effects analysis of Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Body Fat Mass|
1701986|NCT00960375|3129546|Superiority or Other|||||||0.685|||||||ANOVA|||This outcome was examined in the randomized sample. Abstinence was defined as self-reported no smoking in the last 7 days + expired CO ≤ 10 PPM. To assess difference in change between conditions, we tested the significance of the condition-by-time interaction using repeated measured mixed models with a random participant effect. Time was binary: post-treatment versus baseline. We used a logistic model for binary outcomes.|
1701987|NCT00960375|3129547|Superiority or Other|||||||0.489|||||||ANOVA|||Smoking reduction outcomes were examined in the randomized sample using data from baseline and post-treatment assessments. The variable examined was self-reported number of cigarettes smoked per day during the last 7 days. This variable was skewed so a natural log transformation was applied before linear mixed model analysis.|
1701988|NCT00960206|3129553|Superiority or Other|||||||0.206|||||||Fisher Exact|||Compare the # of cases at 10 years for having pain in their hip for all three groups|
1701989|NCT00960206|3129553|Superiority or Other|||||||0.6011|||||||Fisher Exact|||Compare the # of cases at 10 years satisfied with their total hip replacement for all three groups|
1701990|NCT00960206|3129555|Superiority or Other|||||||0.3701|||||||Fisher Exact|||To compare the # of cases at 10 years for those that have a HHS ≥ 80 to those that have < 80 for all three arms|
1701991|NCT00960206|3129556|Superiority or Other|||||||0.1657|||||||Log Rank|||To compare the Kaplan-Meier survivorship between the two systems|
1701992|NCT00960206|3129556|Superiority or Other|||||||0.0832|||||||Log Rank|||To compare the Kaplan-Meier survivorship between the two systems|
1701993|NCT00960115|3129571|Superiority or Other||Hazard Ratio (HR)|0.953||||0.828|2-Sided|95.0|0.614|1.479||This trial was not powered to demonstrate statistical significance of treatment differences with respect to a statistical test, i.e., the p value being lower than a significance level of alpha (α) = 0.05.|Log Rank||Cox proportional hazards regression model||
1701994|NCT00960076|3129572|Superiority or Other||Mean Difference (Net)|11.2||||0.0459|2-Sided|95.0|0.2|22.0|||ANCOVA||||
1701995|NCT00960076|3129573|Superiority or Other||Mean Difference (Net)|-13.18|Standard Error of the Mean|4.409|||2-Sided|95.0|-21.86|-4.5|||||||
1701996|NCT00960076|3129574|Superiority or Other||Mean Difference (Net)|-23.32|Standard Error of the Mean|7.128|||2-Sided|95.0|-37.36|-9.28|||||||
1701997|NCT00960076|3129575|Superiority or Other||Mean Difference (Net)|-0.52|Standard Error of the Mean|0.108|||2-Sided|95.0|-0.73|-0.31|||||||
1701998|NCT00959920|3129628|Superiority or Other||Median Difference (Final Values)|0.8||||0.42|2-Sided||||||t-test, 2 sided|||The null hypothesis is that patients for whom indwelling foley catheterization was employed will have their time to delivery interval reduced by 30 minutes.|
1701999|NCT00959907|3129629|Superiority or Other|||||||0.184|||||||t-test, 2 sided||||
1702000|NCT00959907|3129630|Superiority or Other|||||||0.739|||||||t-test, 2 sided||||
1702001|NCT00959907|3129630|Superiority or Other|||||||0.658|||||||t-test, 2 sided||||
1702002|NCT00959907|3129631|Superiority or Other|||||||0.832|||||||t-test, 2 sided||||
1702003|NCT00959764|3129657|Non-Inferiority or Equivalence|Same as Primary Outcome|Mean Difference (Net)|-18.09|Standard Deviation|47.53||0.0012||||||p-value not adjusted for multiple comparisons; a priori threshold for statistical significance was set at 0.05.|ANCOVA||oral calcitonin vs placebo|Same as Primary Outcome|
1702004|NCT00959764|3129658|Non-Inferiority or Equivalence|Same as for Primary Outcome|Mean Difference (Net)|-21.84|Standard Deviation|41.99||0.0006||||||P-value not adjusted for multiple comparisons; a priori threshold for significance was 0.05|ANCOVA|95% confidence interval not calculated||Same as for Primary Outcome|
1702005|NCT00959764|3129659|Non-Inferiority or Equivalence|"Assumed placebo-adjusted effect for both active treatment groups (% increase in BMD)was 1.56% and that the placebo adjusted effect for the rsCT tablets must be at least 0.5 times the placebo adjusted effect for the calcitonin nasal spray (active control treatment group). The null hypothesis to be tested was:~[Mean(oral) – Mean(placebo)] - 0.5 x [Mean(nasal) – Mean(placebo)] < 0. Reference Pigeot, et al. 2003"|Mean Difference (Net)|0.77|Standard Deviation|2.5||0.002|2-Sided|95.0|0.08|1.45||The P-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was <0.05|ANCOVA|||The overall analysis across groups was an Analysis of Covariance where the study was powered to 80% with an assumption of a standard deviation of 2.5% and a two-sided 5% level of significance. For each treatment group, the BMD at 48 weeks was compared with the BMD at baseline and a % increase was calculated (baseline = 0%). This difference was subjected to the t-test. Two-sided P-value is less than or equal to 0.05 and was not adjusted as multiple comparisons were not done.|
1702006|NCT00959699|3129672|Superiority or Other||Observed Difference|34.2||||0.0007|2-Sided|95.0|14.5|53.9||The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (< or >= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)|Cochran-Mantel-Haenszel|||The methodology for 95% CI is based on the asymptotic normal approximation to the binomial distribution|
1702007|NCT00959699|3129673|Superiority or Other||Strata-Adjusted Difference|33.7||||0.0008|2-Sided|95.0|14.1|53.3||The Cochran-Mantel-Haenszel p-value is adjusted for randomization strata of HCV-RNA (< or >= 800,000 IU/mL) and Cirrhosis/Fibrosis (Yes or No)|Cochran-Mantel-Haenszel|||The methodology for 95% Confidence Interval (CI) is based on a Modified Koch approach which adjusted for Randomization Strata of Cirrhosis/Fibrosis (Yes or No). The adjustment of randomization strata of HCV-RNA (< or >= 800,000 IU/mL) was not possible due to sparse data.|
1702008|NCT00959660|3129674|Superiority|||||||0.26||||||Main effects analysis of Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Skeletal Muscle|
1702009|NCT00959660|3129674|Superiority||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Skeletal Muscle|
1702010|NCT00959660|3129674|Superiority||||||<|0.26||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Subcutaneous Fat|
1702011|NCT00959660|3129674|Superiority||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Thigh Subcutaneous Fat|
1702015|NCT00959660|3129675|Superiority||||||<|0.001||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.||Total Body Fat Mass|
1702016|NCT00959660|3129676|Superiority|||||||0.43||||||Main effects analysis for Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.|||
1702017|NCT00959660|3129676|Superiority|||||||0.004||||||Main effects analyses with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.|||
1702018|NCT00959660|3129677|Superiority||||||<|0.001||||||Main effects analysis with Exercise vs. No Exercise.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.|||
1702019|NCT00959660|3129677|Superiority||||||<|0.001||||||Main effects analysis with Diet vs. No Diet.|ANCOVA|Least Square Mean at follow up adjusted for the following covariates: baseline measure of the outcome measure, sex, and beta blocker usage.|||
1702020|NCT00958919|3129706|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1702021|NCT00958919|3129707|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1702022|NCT00958919|3129708|Superiority or Other|||||||0.45|||||||t-test, 2 sided||||
1702023|NCT00958919|3129709|Superiority or Other||Mean Difference (Net)|4.0||||0.024|2-Sided|95.0|0.49|6.85|||t-test, 2 sided||||
1702024|NCT00958919|3129710|Superiority or Other||Mean Difference (Net)|5.0||||0.0004|2-Sided|95.0|2.69|9.38|||t-test, 2 sided||||
1702025|NCT00958880|3129712|Superiority or Other||Slope|0.03||||0.575||95.0|||||Regression, Linear||||
1702026|NCT00958880|3129713|Superiority or Other||Slope|10.46||||0.015||95.0|||||Regression, Linear||||
1702027|NCT00958789|3129731|Non-Inferiority|"For the primary efficacy hypothesis, H0, the total KSS change from preoperative to 2 years postoperative will be less than or equal to delta. The alternative hypothesis, Ha, will be that the total KSS change from preop to 2 years postoperative is greater than delta. When delta=63, the hypothesis will test for non-inferiority. When delta=70, the hypothesis will test for superiority.~H0: mean 2-year - mean preop less than or equal to delta. Ha: mean 2-year - mean preop greater than delta."|Mean Difference (Final Values)|70.7|||||1-Sided|95.0|64.43||||||||
1702028|NCT00958776|3129735|Superiority or Other|||||||0.758|||||||Cochran-Mantel-Haenszel|Analysis stratified by symptom onset prior to randomization, Baseline ICU status, need for supplemental oxygen at Baseline, influenza season and type.|||
1702029|NCT00958776|3129736|Superiority or Other|||||||0.768|||||||Cochran-Mantel-Haenszel|Analysis stratified by symptom onset prior to randomization, Baseline ICU status, need for supplemental oxygen at Baseline, influenza season and type.|||
1702030|NCT00958776|3129738|Superiority or Other||Hazard Ratio (HR)|1.1||||0.303|2-Sided|95.0|0.41|2.98|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio is calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at baseline, use of supplemental oxygen at baseline, influenza season, and influenza type.||
1702031|NCT00958776|3129740|Superiority or Other||Hazard Ratio (HR)|1.46||||0.747|2-Sided|95.0|0.92|2.32|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.||
1702032|NCT00958776|3129741|Superiority or Other||Hazard Ratio (HR)|0.88||||0.633|2-Sided|95.0|0.59|1.31|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.||
1702033|NCT00958776|3129742|Superiority or Other||Hazard Ratio (HR)|1.14||||0.558|2-Sided|95.0|0.75|1.72|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.||
1702034|NCT00958776|3129744|Superiority or Other||Hazard Ratio (HR)|1.03||||0.973|2-Sided|95.0|0.69|1.55|||Wilcoxon-Gehan statistic|Analysis stratified by duration of illness at randomization, ICU status and use of supplemental oxygen at Baseline, influenza season and type.|The hazard ratio was calculated using a Cox regression model with factors of duration of illness at randomization, ICU status at Baseline, use of supplemental oxygen at Baseline, influenza season, and influenza type.||
1702035|NCT00958568|3129769|Superiority or Other||LS Mean Difference|-1.57|Standard Error of the Mean|1.95||0.421|2-Sided|95.0|-5.42|2.27||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.|||
1702036|NCT00958568|3129770|Superiority or Other|||||||0.392||||||P-value is for suicidal ideation. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702037|NCT00958568|3129771|Superiority or Other||||||<|0.001||||||The threshold for statistical significance was 0.05.|Fisher Exact||||
1702038|NCT00958568|3129772|Superiority or Other||LS Mean Difference|3.92|Standard Error of the Mean|0.49|<|0.001|2-Sided|95.0|2.96|4.88||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.|||
1702039|NCT00958568|3129773|Superiority or Other|||||||0.072||||||P-value is for Normal/Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702098|NCT00958191|3129880|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 3 years|
1702040|NCT00958568|3129773|Superiority or Other|||||||0.344||||||P-value is for Normal to Impaired. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702041|NCT00958568|3129773|Superiority or Other|||||||1||||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702042|NCT00958568|3129773|Superiority or Other|||||||0.031||||||P-value is for Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702043|NCT00958568|3129774|Superiority or Other||LS Mean Difference|5.89|Standard Error of the Mean|1.87||0.002|2-Sided|95.0|2.22|9.56||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.|||
1702044|NCT00958568|3129775|Superiority or Other|||||||0.054||||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702045|NCT00958568|3129775|Superiority or Other|||||||0.014||||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702046|NCT00958568|3129775|Superiority or Other|||||||0.029||||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702047|NCT00958568|3129776|Superiority or Other||LS Mean Difference|13.27|Standard Error of the Mean|7.62||0.083|2-Sided|95.0|-1.72|28.26||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.|||
1702048|NCT00958568|3129777|Superiority or Other|||||||1||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702049|NCT00958568|3129778|Superiority or Other|||||||0.004||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702050|NCT00958568|3129779|Superiority or Other||LS Mean Difference|-3.73|Standard Error of the Mean|1.15||0.001|2-Sided|95.0|-5.99|-1.47||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.|||
1702051|NCT00958568|3129780|Superiority or Other|||||||0.458||||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702052|NCT00958568|3129780|Superiority or Other|||||||0.746||||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702053|NCT00958568|3129780|Superiority or Other|||||||0.139||||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702054|NCT00958568|3129781|Superiority or Other||LS Mean Difference|-1.57|Standard Error of the Mean|4.12||0.703|2-Sided|95.0|-9.69|6.54||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.|||
1702055|NCT00958568|3129782|Superiority or Other|||||||1||||||P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702056|NCT00958568|3129782|Superiority or Other|||||||1||||||P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702057|NCT00958568|3129782|Superiority or Other|||||||0.352||||||P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702058|NCT00958568|3129783|Superiority or Other||LS Mean Difference|-0.91|Standard Error of the Mean|4.47||0.839|2-Sided|95.0|-9.71|7.89||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.|||
1702059|NCT00958568|3129784|Superiority or Other|||||||1||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702060|NCT00958568|3129785|Superiority or Other|||||||0.248||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702061|NCT00958568|3129786|Superiority or Other|||||||1||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Fisher Exact||||
1702062|NCT00958568|3129787|Superiority or Other||LS Mean Difference|-1.94|Standard Error of the Mean|0.72||0.007|2-Sided|95.0|-3.36|-0.53||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment and country.|||
1702063|NCT00958568|3129790|Superiority or Other||LS Mean Difference|-0.34|Standard Error of the Mean|0.11||0.002|2-Sided|95.0|-0.55|-0.12||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.|||
1702099|NCT00958191|3129880|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in Harris Hip Pain Score from pre-op to 1 year|
1702064|NCT00958568|3129791|Superiority or Other||LS Mean Difference|-3.82|||<|0.001|2-Sided|95.0|-5.39|-2.24||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment and country.|||
1702065|NCT00958568|3129792|Superiority or Other||LS Mean Difference|-2.91|Standard Error of the Mean|0.78|<|0.001|2-Sided|95.0|-4.46|-1.36||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|t-test, 2 sided|The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.|||
1702066|NCT00958568|3129793|Superiority or Other|||||||0.047||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Remission rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.|||
1702067|NCT00958568|3129797|Superiority or Other||||||<|0.001||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank||||
1702068|NCT00958568|3129798|Superiority or Other|||||||0.831||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank||||
1702069|NCT00958568|3129799|Superiority or Other||||||<|0.001||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank||||
1702070|NCT00958568|3129800|Superiority or Other||||||<|0.001||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.|||
1702071|NCT00958568|3129801|Superiority or Other|||||||0.713||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.|||
1702072|NCT00958568|3129802|Superiority or Other||||||<|0.001||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.|||
1702073|NCT00958568|3129803|Superiority or Other||||||<|0.001||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.|||
1702074|NCT00958568|3129804|Superiority or Other||||||<|0.001||||||The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.|Log Rank|||Power estimate assumes approximately 1230 participants enter SPII. With a 60% drop-out/disqualification rate in SPII, then 492 participants enter SPIII. If 26% of participants drop out during SPIII, then 364 participants enter SPIV. Assuming 20% drop-out rate, 25% relapse rate on OFC and 40% relapse rate for fluoxetine (hazard ratio = 0.56), the log-rank test is 80% powered to detect a difference at a 2-sided 0.05 level. A total of 95 relapse events during SPIV should satisfy these assumptions.|
1702075|NCT00958360|3129847|Superiority or Other|||||||0.013|||||||t-test, 2 sided||||
1702076|NCT00958360|3129848|Superiority or Other|||||||0.013|||||||t-test, 2 sided||||
1702077|NCT00958360|3129849|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1702078|NCT00958360|3129850|Superiority or Other|||||||0.13|||||||t-test, 2 sided||||
1702079|NCT00958360|3129851|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1702080|NCT00958308|3129859|Superiority or Other||||||=|0|||||||Fisher Exact|||The sample size calculation was based on the incidence of AAD. A total of 255 patients was enrolled in order to obtain at least the required 225 evaluable patients.With expected AAD rates of at most 15% - 25% in the treatment groups; and 25% - 35% in the placebo group, these numbers were sufficient to detect the difference in the incidence of AAD between either of the treatment groups vs. placebo with a minimum of 86% statistical power.|
1702081|NCT00958217|3129873|Superiority or Other||Second order effect of time (2 slopes)|0.26|||<|0.05|2-Sided||||||Linear Mixed Effects Model|A logit link was used in this model|We gauged sampling error with 95% confidence bands.|Second statistical analysis evaluates trajectories of heavy drinking (<5 drinks on a given day) Analysis of heavy drinking was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of heavy drinking (5 or more drinks) on a particular day.|
1702082|NCT00958217|3129873|Superiority or Other||Second order effect of time (2 slopes)|0.43|||<|0.05|2-Sided|95.0|||||Linear Mixed Effects Model|A logit link was used in this model.|We gauged sampling error with 95% confidence bands.|Analysis of substance use was conducted using trajectories modeled as a dichotomous outcome using logit links to predict the probability of substance use (any alcohol or drug use) on a particular day.|
1702083|NCT00958217|3129874|Superiority or Other||Second order effect of time (2 slopes)|57.0|||<|0.05|2-Sided|95.0|||||Linear Mixed Effects Models||We gauged sampling error with 95% confidence bands.||
1702084|NCT00958217|3129875|Superiority or Other||2nd order effects of time (2 slope|33.0|||<|0.05|2-Sided|95.0||||P-values based on likelihood ratio tests for the significance of the first and second order trajectory parameters. Primary tests compared curvilinear trajectories of the two treatment groups.|Linear Mixed Effects Models||We gauged sampling error with 95% confidence bands.|Data analyses included comparison of mean scores and linear mixed effects models used to ascertain trajectories for depression symptoms.|
1702085|NCT00958191|3129877|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in LEAS Score from preop to 5 year|
1702086|NCT00958191|3129877|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in LEAS Score from preop to 3 year|
1702087|NCT00958191|3129877|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in LEAS Score from preop to 1 year|
1702088|NCT00958191|3129878|Superiority or Other|||||||0.1372|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 5 year|
1702089|NCT00958191|3129878|Superiority or Other|||||||0.0247|||||||Sign test|||Change in SF-12 Mental Component Score from preop to 3 year|
1702100|NCT00958191|3129881|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change in HHS from pre-op to 5 years|
1702102|NCT00958191|3129881|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in HHS from pre-op to 1 year|
1702103|NCT00958009|3129903|Superiority or Other||mean positive response|0.86|||||2-Sided|95.0|0.8|0.93|||||Confidence Interval calculated from normal approximation to the binomial. The primary objective was met if the lower bound of the 95% confidence interval is >0.50.||
1702104|NCT00957944|3129929|Non-Inferiority or Equivalence|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0289||||||90.0|0.9714|1.0899|||||Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).|
1702105|NCT00957944|3129930|Non-Inferiority or Equivalence|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0571||||||90.0|0.9903|1.1284|||||Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).|
1702106|NCT00957944|3129931|Non-Inferiority or Equivalence|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|1.0302||||||90.0|0.9693|1.0951|||||Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz), AUC(0-inf) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).|
1702107|NCT00957723|3129987|Superiority or Other||||||<|0.0001|||||||Sign test|||LEAS score change from preop to 1, 2, 3, 4, and 5 years|
1702108|NCT00957723|3129989|Superiority or Other|||||||0.0037|||||||Sign test|||SF36 Mental Component Score change from preop to 5 year|
1702109|NCT00957723|3129989|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 5 year|
1702110|NCT00957723|3129989|Superiority or Other||||||<|0.4905|||||||t-test, 2 sided|||SF36 Mental Component Score change from preop to 4 year|
1702111|NCT00957723|3129989|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 4 year|
1702112|NCT00957723|3129989|Superiority or Other||||||<|0.0393|||||||Sign test|||SF36 Mental Component Score change from preop to 3 year|
1702113|NCT00957723|3129989|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 3 year|
1702114|NCT00957723|3129989|Superiority or Other||||||<|0.0177|||||||Sign test|||SF36 Mental Component Score change from preop to 2 years|
1702115|NCT00957723|3129989|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||SF36 Physical Component Score change from preop to 2 years|
1702116|NCT00957723|3129989|Superiority or Other||||||<|0.0002|||||||Sign test|||SF36 Mental Component Score change from preop to 1 year|
1702117|NCT00957723|3129989|Superiority or Other||||||<|0.0001|||||||Sign test|||SF36 Physical Component Score change from preop to 1 year|
1702118|NCT00957723|3129991|Superiority or Other||||||<|0.0001|||||||Sign test|||Change from pre-op to 1, 2, and 5 year|
1702119|NCT00957723|3129992|Superiority or Other||||||<|0.0001|||||||Sign test|||Change from pre-op to 1 year, 2 year and 5 year|
1702120|NCT00957658|3130049|Superiority or Other|||||||0.0002|||||||Sign test|||Compare Wrist DXA T-score preop to 5 years|
1702121|NCT00957658|3130050|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Compare to historical control (n=94 hips): mean wear 5 years = 0.134 (0.078)|
1702122|NCT00957658|3130053|Superiority or Other||||||<|0.0001|||||||Sign test|||Compare LEAS score preop to 2 years and preop to 5 years|
1702123|NCT00957658|3130054|Superiority or Other|||||||0.0004|||||||t-test, 2 sided|||Compare SF-12 Mental Score preop to 5 years|
1702124|NCT00957658|3130054|Superiority or Other||||||<|0.0001|||||||Sign test|||Change in SF-12 Mental Score preop to 2 years|
1702125|NCT00957658|3130054|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Compare Pre-op SF-12 Physical Score preop to 2 year and preop to 5 year|
1702126|NCT00957658|3130055|Superiority or Other||||||<|0.0001|||||||Sign test|||Improvement from preop to 2 year and preop to 5 year|
1702127|NCT00957658|3130058|Non-Inferiority or Equivalence|Non-inferiority margin = 6%|||||<|0.0001|||||||Asymptotic WALD test|||Literature control = 96% with no aseptic loosening, intraop femoral fracture or thigh pain at 2 years|
1702128|NCT00957242|3130161|Superiority or Other||t-value|-0.48||||0.009|2-Sided|95.0|-0.84|-0.12|||Mixed Models Analysis||||
1702129|NCT00957242|3130162|Superiority or Other||t-value|0.05||||0.957|2-Sided|95.0|-1.67|1076.0|||Mixed Models Analysis||||
1702130|NCT00957242|3130163|Superiority or Other||t-value|-1.78||||0.27|2-Sided|95.0|-7.04|3048.0|||Mixed Models Analysis||||
1702131|NCT00957242|3130164|Superiority or Other||t-value|10.88||||0.7222|2-Sided|95.0|-49.57|71.34|||Mixed Models Analysis||||
1702132|NCT00957242|3130165|Superiority or Other||Hazard Ratio (HR)|0.91||||0.88|2-Sided|95.0|0.24|3.39|||Cox Proportional||||
1702133|NCT00957242|3130166|Superiority or Other||Hazard Ratio (HR)|3.24||||0.15|2-Sided|95.0|0.65|16.1|||Cox Proportional||||
1702134|NCT00957242|3130167|Superiority or Other||Hazard Ratio (HR)|2.25||||0.35|2-Sided|95.0|0.41|12.34|||Cox Proportional||||
1702135|NCT00957242|3130168|Superiority or Other||Hazard Ratio (HR)|2.47||||0.19|2-Sided|95.0|0.64|9.56|||Cox Proportional||||
1702136|NCT00957242|3130169|Superiority or Other||Hazard Ratio (HR)|2.06||||0.054|2-Sided|95.0|0.99|4.31|||Cox Proportional||||
1702137|NCT00957242|3130170|Superiority or Other||t-value|0.08||||0.083||95.0|-0.01|0.17|||Mixed Models Analysis||||
1702138|NCT00957242|3130171|Superiority or Other||Cox Proportional Hazard|5.03||||0.005|2-Sided|95.0|1.44|17.54|||Cox Proportional||||
1702171|NCT00955708|3130297|Other|Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.|Kaplan-Meier Rate|100.0|||||1-Sided|95.0|100.0|||||||The non-modified primary endpoint analysis initially included confirmed chronic LV lead related complications that result in permanent loss of therapy, invasive intervention, injury or death, and are deemed attributable to a structural lead failure by an independent Clinical Events Committee (CEC). These results are represented here.|
1702139|NCT00957242|3130172|Superiority or Other||Cox Proportional Hazard|1.32||||0.27|2-Sided|95.0|0.7|2.47|||Regression, Cox|Prespecified covariates in the model included an indicator variable for the treatment group and the DLCO measurement from the baseline assessment.|Warfarin vs. Placebo|The study was designed to have 90% power to detect a difference in 48-week event free rates of 70% for the warfarin group versus 50% for the placebo group. A total of at least 95 adjudicated primary endpoints were required to achieve 90% power with 2-sided, type I error rate of 0.05 and a 1:1 randomization ratio. These calculations yielded a requisite total sample size of 256.|
1702140|NCT00957021|3130182|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||LEAS score comparison from pre-op to 1, 2, 3, 4 and 5 years|
1702141|NCT00957021|3130184|Superiority or Other|||||||0.0018|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 5 year|
1702142|NCT00957021|3130184|Superiority or Other|||||||0.005|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 4 year|
1702143|NCT00957021|3130184|Superiority or Other|||||||0.0055|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 3 year|
1702144|NCT00957021|3130184|Superiority or Other|||||||0.0017|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 2 year|
1702145|NCT00957021|3130184|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||SF-36 Mental score comparison from pre-op to 1 year|
1702146|NCT00957021|3130184|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||SF-36 Physical score comparison from pre-op to 1, 2, 3, 4 and 5 years|
1702147|NCT00957021|3130185|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||KSS Pain/Motion and Function Score comparison from pre-op to 1, 2 and 5 year|
1702148|NCT00956930|3130196|Superiority or Other (legacy)||Hazard Ratio (HR)|0.122||||0.007|2-Sided|95.0|0.027|0.557|||Log Rank||||
1702149|NCT00956813|3130199|Superiority or Other|||||||0.089|||||||Kruskal-Wallis||||
1702150|NCT00956813|3130200|Superiority or Other|||||||0.497|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Sexually-related questions in the MENQOL form.|
1702151|NCT00956813|3130200|Superiority or Other|||||||0.238|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Physical-related questions in the MENQOL form.|
1702152|NCT00956813|3130200|Superiority or Other|||||||0.78|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for Psychosocial-related questions in the MENQOL form.|
1702153|NCT00956813|3130200|Superiority or Other|||||||0.19|||||||Kruskal-Wallis|||Testing the change in score from baseline to treatment completion for vasomotor-related questions in the MENQOL form.|
1702154|NCT00956813|3130201|Superiority or Other|||||||0.93|||||||Kruskal-Wallis||||
1702155|NCT00956813|3130203|Superiority or Other|||||||0.29|||||||t-test, 2 sided||||
1702156|NCT00956709|3130208|Superiority or Other|||||||0.0445|||||||Wilcoxon (Mann-Whitney)||||
1702157|NCT00956709|3130209|Superiority or Other|||||||0.3354|||||||Wilcoxon (Mann-Whitney)||||
1702158|NCT00956709|3130211|Superiority or Other|||||||0.56||||||Two patients in each group had incomplete block before sugery.|Wilcoxon (Mann-Whitney)||||
1702159|NCT00956631|3130215|Superiority or Other||Mean Difference (Final Values)|17.58|||<|0.0001|2-Sided|95.0|12.33|22.83|||t-test, 2 sided|||The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used. A hypothetical average improvement of zero was used.|
1702160|NCT00956631|3130216|Superiority or Other||Mean Difference (Final Values)|3.2|||<|0.0001|2-Sided|95.0|2.29|4.13|||t-test, 2 sided|||The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used throughout. A hypothetical average improvement of zero was used.|
1702161|NCT00955968|3130262|Superiority||Hazard Ratio (HR)|0.86||||0.1|2-Sided|95.0|0.72|1.03||5% alpha level and 2-sided test|Log Rank||||
1702162|NCT00955968|3130263|Superiority||Hazard Ratio (HR)|0.58|||<|0.001|2-Sided|95.0|0.42|0.8||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART||
1702163|NCT00955968|3130264|Superiority||Hazard Ratio (HR)|0.91||||0.71|2-Sided|95.0|0.54|1.52||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART||
1702164|NCT00955968|3130265|Superiority||Hazard Ratio (HR)|0.93||||0.79|2-Sided|95.0|0.54|1.6||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART||
1702165|NCT00955968|3130266|Superiority||Hazard Ratio (HR)|0.52||||0.44|2-Sided|95.0|0.09|2.81||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART||
1702166|NCT00955968|3130268|Superiority||Hazard Ratio (HR)|0.67||||0.66|2-Sided|95.0|0.11|4.01||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART||
1702167|NCT00955968|3130269|Superiority||Hazard Ratio (HR)|0.68||||0.54|2-Sided|95.0|0.19|2.4||5% alpha level and 2-sided test|Log Rank||HR reflects Continue HAART : Stop HAART||
1702168|NCT00955955|3130271|Superiority or Other||Mean Score Reduction|-5.6|Standard Deviation|5.7||0.05||95.0|||||SPCD|Sequential Parallel Comparison Design (SPCD)|These results reflect the mean score reduction for the pooled Deplin sample.|Hypothesis 1: There will be a statistically significant difference between the two groups in the degree of improvement, as measured by the change in the 17-item Hamilton Depression Rating Scale (HAM-D-17) score from baseline to endpoint, using the sequential parallel comparison design [51]; with a greater degree of reduction in HAM-D-17 scores in the 6(S)-5-MTHF 15 mg qd group than in the placebo group, with the change on placebo being estimated from Trials 1 and 2.|
1702169|NCT00955825|3130289|Superiority or Other||LS Mean difference vs. Placebo|-0.126||||0.0003||95.0|-0.194|-0.058|||ANCOVA||Relative LS Means difference (%) = - 28.24||
1702170|NCT00955747|3130290|Superiority or Other||Mean Difference (Net)|0.5|Standard Deviation|1.4|<|0.05|2-Sided|95.0|||||ANCOVA|||All tests will be two-tailed. Unless specified otherwise, p-values less than or equal to O.050, when rounded to four decimal places,will be considered statistically significant.|
1702222|NCT00955201|3130411|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702223|NCT00955201|3130411|Superiority|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702172|NCT00955708|3130297|Other|Primary endpoint was estimated using the Kaplan-Meier method. In addition, Greenwood's formula was used to calculate the lower one-sided 95% confidence bound.|Kaplan-Meier Rate|95.3|||||1-Sided|95.0|94.0||||||The lower one-sided 95% confidence bound was pre-specified to be greater than 92.5%.|The endpoint data reflected here is a modified primary endpoint analysis requested by the Food and Drug Administration early in the registry to include data that is related to the left ventricular lead function in a chronic setting.|
1702173|NCT00955305|3130383|Superiority or Other|||||||0.15||||||two sided p-value by Fisher's exact test|Fisher Exact||||
1702174|NCT00955305|3130384|Superiority or Other|||||||0.95||||||two-sided p-value by stratified log rank test stratified on the randomization stratification factors|Log Rank|Stratified log rank test stratified on the randomization stratification factors|||
1702175|NCT00955305|3130385|Superiority or Other|||||||0.33||||||one-sided p-value using stratified logrank test stratified on the randomization stratification factors|Log Rank|Stratified log rank test stratified on the randomization stratification factors|||
1702176|NCT00955279|3130386|Superiority or Other|||||||0.546|||||||Linear Contrast Test||||
1702177|NCT00955279|3130386|Superiority or Other|||||||0.451|||||||Linear Contrast Test||||
1702178|NCT00955279|3130387|Superiority or Other|||||||0.2772|||||||Fisher Exact||||
1702179|NCT00955279|3130387|Superiority or Other|||||||0.1931|||||||Fisher Exact||||
1702180|NCT00955279|3130388|Superiority or Other|||||||0.073|||||||Linear Contrasts Test||||
1702181|NCT00955279|3130388|Superiority or Other|||||||0.374|||||||Linear Contrasts Test||||
1702182|NCT00955279|3130389|Superiority or Other|||||||0.063|||||||Linear Contrasts Test||||
1702183|NCT00955279|3130389|Superiority or Other|||||||0.896|||||||Linear Contrasts Test||||
1702184|NCT00955279|3130390|Superiority or Other|||||||0.126|||||||ANCOVA||||
1702185|NCT00955279|3130390|Superiority or Other|||||||0.543|||||||ANCOVA||||
1702186|NCT00955253|3130397|Superiority|||||||0.013|||||||t-test, 2 sided|||between the placebo and guanfacine conditions|
1702187|NCT00955201|3130398|Superiority|||||||0.79|||||||ANOVA|||Comparison across groups at baseline.|
1702188|NCT00955201|3130399|Superiority|||||||0.42|||||||ANOVA|||Comparison across groups at baseline.|
1702189|NCT00955201|3130400|Superiority|||||||0.12|||||||ANOVA|||Comparison across groups at baseline.|
1702190|NCT00955201|3130401|Superiority|||||||0.77|||||||ANOVA|||Comparison across groups at baseline.|
1702191|NCT00955201|3130402|Superiority|||||||0.04|||||||ANOVA|||Comparison across groups at baseline.|
1702192|NCT00955201|3130403|Superiority|||||||0.45|||||||ANOVA|||Comparison across groups at baseline.|
1702193|NCT00955201|3130404|Superiority|||||||0.59|||||||ANOVA|||Comparison across groups at baseline.|
1702194|NCT00955201|3130406|Superiority|||||||0.7|||||||ANOVA|||Comparison across groups at baseline.|
1702195|NCT00955201|3130407|Superiority|||||||0.68|||||||ANOVA|||Comparison across groups at 24 wks.|
1702196|NCT00955201|3130407|Superiority|||||||0.53|||||||ANOVA|||Comparison across groups at 12 wks.|
1702197|NCT00955201|3130407|Superiority|||||||0.82|||||||ANOVA|||Comparison across groups at baseline.|
1702198|NCT00955201|3130407|Superiority|||||||0.76||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702199|NCT00955201|3130407|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702200|NCT00955201|3130407|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702201|NCT00955201|3130407|Superiority|||||||0.88||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702202|NCT00955201|3130408|Superiority|||||||0.38|||||||ANOVA|||Comparison across groups at 24 wks.|
1702203|NCT00955201|3130408|Superiority|||||||0.33|||||||ANOVA|||Comparison across groups at 12 wks.|
1702204|NCT00955201|3130408|Superiority|||||||0.62|||||||ANOVA|||Comparison across groups at baseline.|
1702205|NCT00955201|3130408|Superiority|||||||0.72||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702206|NCT00955201|3130408|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702207|NCT00955201|3130408|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702208|NCT00955201|3130408|Superiority|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702209|NCT00955201|3130409|Superiority|||||||0.59|||||||ANOVA|||Comparison across groups at baseline.|
1702210|NCT00955201|3130410|Superiority|||||||0.99|||||||Kruskal-Wallis|||Comparison across groups at 24-wks|
1702211|NCT00955201|3130410|Superiority|||||||0.6|||||||Kruskal-Wallis|||Comparison across groups at 12-wks|
1702212|NCT00955201|3130410|Superiority|||||||0.81|||||||Kruskal-Wallis|||Comparison across groups at baseline|
1702213|NCT00955201|3130410|Superiority|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time.|
1702214|NCT00955201|3130410|Superiority|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time|
1702215|NCT00955201|3130410|Superiority|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time|
1702216|NCT00955201|3130410|Superiority|||||||1||||||Dunn's multiple comparisons test:|Kruskal-Wallis|||Evaluate within group across time|
1702217|NCT00955201|3130411|Superiority|||||||0.37|||||||ANOVA|||Comparison across groups at 24-wks|
1702218|NCT00955201|3130411|Superiority|||||||0.55|||||||ANOVA|||Comparison across groups at 12-wks.|
1702219|NCT00955201|3130411|Superiority|||||||0.38|||||||ANOVA|||Comparison across groups at baseline.|
1702220|NCT00955201|3130411|Superiority|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702221|NCT00955201|3130411|Superiority|||||||0.88||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702224|NCT00955201|3130412|Superiority|||||||0.33|||||||ANOVA|||Comparison across groups at 24-wks.|
1702226|NCT00955201|3130412|Superiority|||||||0.58|||||||ANOVA|||Comparison across groups at baseline.|
1702227|NCT00955201|3130412|Superiority|||||||0.48||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702228|NCT00955201|3130412|Superiority|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702229|NCT00955201|3130412|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702230|NCT00955201|3130412|Superiority|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702231|NCT00955201|3130413|Superiority|||||||0.03|||||||ANOVA|||Comparison across groups at 24-wks.|
1702232|NCT00955201|3130413|Superiority|||||||0.41|||||||ANOVA|||Comparison across groups at 12-wks.|
1702233|NCT00955201|3130413|Superiority|||||||0.11|||||||ANOVA|||Comparison across groups at baseline.|
1702234|NCT00955201|3130413|Superiority|||||||0.05||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702235|NCT00955201|3130413|Superiority|||||||0.09||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702236|NCT00955201|3130413|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702237|NCT00955201|3130413|Superiority|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time|
1702238|NCT00955201|3130414|Superiority|||||||0.29|||||||ANOVA|||Comparison across groups at 24-wks.|
1702239|NCT00955201|3130414|Superiority|||||||0.59|||||||ANOVA|||Comparison across groups at 12-wks.|
1702240|NCT00955201|3130414|Superiority|||||||0.39|||||||ANOVA|||Comparison across groups at baseline.|
1702241|NCT00955201|3130414|Superiority|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702242|NCT00955201|3130414|Superiority|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702243|NCT00955201|3130414|Superiority|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702244|NCT00955201|3130414|Superiority|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702245|NCT00955201|3130415|Superiority|||||||0.22|||||||ANOVA|||Comparison across groups at 24wks.|
1702246|NCT00955201|3130415|Superiority|||||||0.72|||||||ANOVA|||Comparison across groups at 12 wks.|
1702247|NCT00955201|3130415|Superiority|||||||0.46|||||||ANOVA|||Comparison across groups at baseline.|
1702248|NCT00955201|3130415|Superiority|||||||0.89||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702249|NCT00955201|3130415|Superiority|||||||0.51||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702250|NCT00955201|3130415|Superiority|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702251|NCT00955201|3130415|Superiority|||||||0.87||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702252|NCT00955201|3130416|Superiority|||||||0.38|||||||ANOVA|||Comparison across groups at 24 wks.|
1702253|NCT00955201|3130416|Superiority|||||||0.48|||||||ANOVA|||Comparison across groups at 12 wks.|
1702254|NCT00955201|3130416|Superiority|||||||0.88|||||||ANOVA|||Comparison across groups at baseline.|
1702255|NCT00955201|3130416|Superiority|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702256|NCT00955201|3130416|Superiority|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702257|NCT00955201|3130416|Superiority|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702258|NCT00955201|3130416|Superiority|||||||0.84||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702259|NCT00955201|3130417|Superiority|||||||0.43|||||||ANOVA|||Comparison across groups at 24 wks.|
1702260|NCT00955201|3130417|Superiority|||||||0.47|||||||ANOVA|||Comparison across groups at 12 wks.|
1702261|NCT00955201|3130417|Superiority|||||||0.4||||||Tukey's multiple comparisons test:|ANOVA|||Comparison across groups at baseline.|
1702262|NCT00955201|3130417|Superiority|||||||0.55||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702263|NCT00955201|3130417|Superiority|||||||0.67||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702264|NCT00955201|3130417|Superiority|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702265|NCT00955201|3130417|Superiority|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702266|NCT00955201|3130418|Superiority|||||||0.01|||||||ANOVA|||Comparison across groups at 24 wks.|
1702267|NCT00955201|3130418|Superiority|||||||0.05|||||||ANOVA|||Comparison across groups at 12 wks.|
1702268|NCT00955201|3130418|Superiority|||||||0.14|||||||ANOVA|||Comparison across groups at baseline.|
1702269|NCT00955201|3130418|Superiority|||||||0.46||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702270|NCT00955201|3130418|Superiority|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702271|NCT00955201|3130418|Superiority|||||||0.36||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702272|NCT00955201|3130418|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702273|NCT00955201|3130419|Superiority|||||||0.14|||||||Kruskal-Wallis|||Comparison across groups at 24-wks|
1702274|NCT00955201|3130419|Superiority|||||||0.06|||||||Kruskal-Wallis|||Comparison across groups at 12-wks|
1702275|NCT00955201|3130419|Superiority|||||||0.96|||||||Kruskal-Wallis|||Comparison across groups at baseline|
1702276|NCT00955201|3130419|Superiority|||||||0.98||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time|
1702380|NCT00955201|3130434|Superiority|||||||0.8|||||||ANOVA|||Comparison across groups at baseline.|
1702277|NCT00955201|3130419|Superiority|||||||1||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time|
1702278|NCT00955201|3130419|Superiority|||||||0.01||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time|
1702279|NCT00955201|3130419|Superiority|||||||1||||||Dunn's multiple comparisons|Kruskal-Wallis|||Evaluate within group across time|
1702280|NCT00955201|3130420|Superiority|||||||0.59||||||ANOVA|ANOVA|||Comparison of pre- and post-test responses across groups at 24 wks.|
1702281|NCT00955201|3130420|Superiority|||||||0.51||||||ANOVA|ANOVA|||Comparison of pre- and post-test responses across groups at 12 wks.|
1702282|NCT00955201|3130420|Superiority|||||||0.2||||||ANOVA|ANOVA|||Comparison of pre- and post-responses across groups at baseline.|
1702283|NCT00955201|3130420|Superiority|||||||0.15||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.|
1702284|NCT00955201|3130420|Superiority|||||||0.36||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.|
1702285|NCT00955201|3130420|Superiority|||||||0.29||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.|
1702286|NCT00955201|3130420|Superiority|||||||0.03||||||Unpaired two-tailed t-test:|t-test, 2 sided|||Evaluate within group pre- and post-test responses across time.|
1702287|NCT00955201|3130421|Superiority|||||||0.92|||||||ANOVA|||Comparison across groups at 24-wks.|
1702288|NCT00955201|3130421|Superiority|||||||0.86|||||||ANOVA|||Comparison across groups at 12-wks.|
1702289|NCT00955201|3130421|Superiority|||||||0.96|||||||ANOVA|||Comparison across groups at baseline.|
1702290|NCT00955201|3130421|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702291|NCT00955201|3130421|Superiority|||||||0.84||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702292|NCT00955201|3130421|Superiority|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702293|NCT00955201|3130421|Superiority|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702294|NCT00955201|3130422|Superiority|||||||0.91|||||||ANOVA|||Comparison across groups at 24-wks.|
1702295|NCT00955201|3130422|Superiority|||||||0.94|||||||ANOVA|||Comparison across groups at 12-wks|
1702296|NCT00955201|3130422|Superiority|||||||0.98|||||||ANOVA|||Comparison across groups at baseline|
1702297|NCT00955201|3130422|Superiority|||||||0.9||||||Tukey's multiple comparisons test:|ANOVA|||Evaluate within group across time.|
1702298|NCT00955201|3130422|Superiority|||||||0.89||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702299|NCT00955201|3130422|Superiority|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702300|NCT00955201|3130422|Superiority|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702301|NCT00955201|3130423|Superiority|||||||0.63|||||||ANOVA|||Comparison across groups at 24-wks.|
1702302|NCT00955201|3130423|Superiority|||||||0.51|||||||ANOVA|||Comparison across groups at 12-wks|
1702303|NCT00955201|3130423|Superiority|||||||0.75|||||||ANOVA|||Comparison across groups at baseline|
1702304|NCT00955201|3130423|Superiority|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702305|NCT00955201|3130423|Superiority|||||||0.79||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702306|NCT00955201|3130423|Superiority|||||||0.53||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702307|NCT00955201|3130423|Superiority|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702308|NCT00955201|3130424|Superiority|||||||0.95|||||||ANOVA|||Comparison across groups at 24-wks.|
1702309|NCT00955201|3130424|Superiority|||||||0.42|||||||ANOVA|||Comparison across groups at 12-wks|
1702310|NCT00955201|3130424|Superiority|||||||0.26|||||||ANOVA|||Comparison across groups at baseline.|
1702311|NCT00955201|3130424|Superiority|||||||0.95||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702312|NCT00955201|3130424|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702313|NCT00955201|3130424|Superiority|||||||0.91||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702314|NCT00955201|3130424|Superiority|||||||0.83||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702315|NCT00955201|3130425|Superiority|||||||0.97|||||||ANOVA|||Comparison across groups at 24-wks|
1702316|NCT00955201|3130425|Superiority|||||||0.47|||||||ANOVA|||Comparison across groups at 12-wks.|
1702317|NCT00955201|3130425|Superiority|||||||0.5|||||||ANOVA|||Comparison across groups at baseline.|
1702318|NCT00955201|3130425|Superiority|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702319|NCT00955201|3130425|Superiority|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702320|NCT00955201|3130425|Superiority|||||||0.92||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702321|NCT00955201|3130425|Superiority|||||||0.81||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702322|NCT00955201|3130426|Superiority|||||||0.32|||||||ANOVA|||Comparison across groups at 24-wks|
1702323|NCT00955201|3130426|Superiority|||||||0.31|||||||ANOVA|||Comparison across groups at 12-wks|
1702324|NCT00955201|3130426|Superiority|||||||0.55|||||||ANOVA|||Comparison across groups at baseline.|
1702325|NCT00955201|3130426|Superiority|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702326|NCT00955201|3130426|Superiority|||||||0.82||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702327|NCT00955201|3130426|Superiority|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702328|NCT00955201|3130426|Superiority|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702329|NCT00955201|3130427|Superiority|||||||0.83|||||||ANOVA|||Comparison across groups at 24-wks|
1702330|NCT00955201|3130427|Superiority|||||||0.28|||||||ANOVA|||Comparison across groups at 12-wks|
1702331|NCT00955201|3130427|Superiority|||||||0.28|||||||ANOVA|||Comparison across groups at baseline|
1702332|NCT00955201|3130427|Superiority|||||||0.81||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702333|NCT00955201|3130427|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702334|NCT00955201|3130427|Superiority|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702335|NCT00955201|3130427|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702336|NCT00955201|3130428|Superiority|||||||0.75|||||||ANOVA|||Comparison across groups at 24-wks|
1702337|NCT00955201|3130428|Superiority|||||||0.37|||||||ANOVA|||Comparison across groups at 12-wks|
1702338|NCT00955201|3130428|Superiority|||||||0.16|||||||ANOVA|||Comparison across groups at baseline.|
1702339|NCT00955201|3130428|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702340|NCT00955201|3130428|Superiority|||||||0.96||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702341|NCT00955201|3130428|Superiority|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time.|
1702342|NCT00955201|3130428|Superiority|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702343|NCT00955201|3130429|Superiority|||||||0.94|||||||ANOVA|||Comparison across groups at 24-wks|
1702344|NCT00955201|3130429|Superiority|||||||0.51|||||||ANOVA|||Comparison across groups at 12-wks|
1702345|NCT00955201|3130429|Superiority|||||||0.38|||||||ANOVA|||Comparison across groups at baseline|
1702346|NCT00955201|3130429|Superiority|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702347|NCT00955201|3130429|Superiority|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702348|NCT00955201|3130429|Superiority|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702349|NCT00955201|3130429|Superiority|||||||0.91||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702350|NCT00955201|3130430|Superiority|||||||0.68|||||||ANOVA|||Comparison across groups at 24-wks|
1702351|NCT00955201|3130430|Superiority|||||||0.98|||||||ANOVA|||Comparison across groups at 12-wks|
1702352|NCT00955201|3130430|Superiority|||||||0.85|||||||ANOVA|||Comparison across groups at baseline|
1702353|NCT00955201|3130430|Superiority|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702354|NCT00955201|3130430|Superiority|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702355|NCT00955201|3130430|Superiority|||||||0.72||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702356|NCT00955201|3130430|Superiority|||||||0.99||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702357|NCT00955201|3130431|Superiority|||||||0.51|||||||ANOVA|||Comparison across groups at 24-wks|
1702358|NCT00955201|3130431|Superiority|||||||0.91|||||||ANOVA|||Comparison across groups at 12-wks|
1702359|NCT00955201|3130431|Superiority|||||||0.45|||||||ANOVA|||Comparison across groups at baseline|
1702360|NCT00955201|3130431|Superiority|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702361|NCT00955201|3130431|Superiority|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702362|NCT00955201|3130431|Superiority|||||||0.69||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702363|NCT00955201|3130431|Superiority|||||||0.94||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702364|NCT00955201|3130432|Superiority|||||||0.99|||||||ANOVA|||Comparison across groups at 24-wks|
1702365|NCT00955201|3130432|Superiority|||||||0.97|||||||ANOVA|||Comparison across groups at 12-wk|
1702366|NCT00955201|3130432|Superiority|||||||0.63|||||||ANOVA|||Comparison across groups at baseline|
1702367|NCT00955201|3130432|Superiority|||||||0.78||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702368|NCT00955201|3130432|Superiority|||||||0.97||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702369|NCT00955201|3130432|Superiority|||||||0.9||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702370|NCT00955201|3130432|Superiority|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702371|NCT00955201|3130433|Superiority|||||||0.22|||||||ANOVA|||Comparison across groups at 24-wks|
1702372|NCT00955201|3130433|Superiority|||||||0.45|||||||ANOVA|||Comparison across groups at 12-wks|
1702373|NCT00955201|3130433|Superiority|||||||0.7|||||||ANOVA|||Comparison across groups at baseline|
1702374|NCT00955201|3130433|Superiority|||||||0.98||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702375|NCT00955201|3130433|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702376|NCT00955201|3130433|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702377|NCT00955201|3130433|Superiority|||||||0.39||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702378|NCT00955201|3130434|Superiority|||||||0.31|||||||ANOVA|||Comparison across groups at 24-wk|
1702381|NCT00955201|3130434|Superiority|||||||0.93||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702382|NCT00955201|3130434|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702383|NCT00955201|3130434|Superiority|||||||1||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702384|NCT00955201|3130434|Superiority|||||||0.53||||||Tukey's multiple comparisons test:|ANOVA|||Evaluated within group across time|
1702385|NCT00955201|3130435|Superiority|||||||0.28|||||||ANOVA|||Comparison across groups at 24-wk|
1702386|NCT00955201|3130435|Superiority|||||||0.31|||||||ANOVA|||Comparison across groups at 12-wk|
1702387|NCT00955201|3130435|Superiority|||||||0.63|||||||ANOVA|||Comparison across groups at baseline|
1702388|NCT00955201|3130435|Superiority|||||||0.93||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time|
1702389|NCT00955201|3130435|Superiority|||||||0.96||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time|
1702390|NCT00955201|3130435|Superiority|||||||0.82||||||Tukey's multiple comparisons test|ANOVA|||Evaluated within group across time|
1702391|NCT00955201|3130435|Superiority|||||||0.49||||||Tukey's multiple comparisons test|ANOVA|Comparison to baseline values||Evaluated within group across time|
1702392|NCT00955110|3130436|Superiority or Other||Least Square Mean Difference|66.8|||<|0.001|2-Sided|95.0|53.9|79.7||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA||||
1702393|NCT00955110|3130436|Superiority or Other||Least Square Mean Difference|56.0|||<|0.001|2-Sided|95.0|43.1|68.9||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA||||
1702394|NCT00955110|3130436|Superiority or Other||Least Square Mean Difference|38.0|||<|0.001|2-Sided|95.0|25.2|50.8||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA||||
1702395|NCT00955110|3130436|Superiority or Other||Least Square Mean Difference|5.5|||<|0.395|2-Sided|95.0|-7.3|18.3||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA||||
1702396|NCT00955110|3130436|Superiority or Other||Least Square Mean Difference|-50.5|||<|0.001|2-Sided|95.0|-63.4|-37.5||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA||||
1702397|NCT00955110|3130436|Superiority or Other||Least Square Means Difference|-28.8|||<|0.001|2-Sided|95.0|-41.6|-16.0||A mixed-effect model for a crossover study was used, including treatment, period, treatment sequence and first-order carryover effect as fixed effects, pre-dose measurement as covariate, and subjects nested within treatment sequence as random effect.|ANCOVA||||
1702398|NCT00954707|3130453|Superiority or Other||Rate of non-cardiac death (%)|0.69|||||2-Sided|95.0|0.4|1.12|||||||
1702399|NCT00954707|3130454|Superiority or Other||Rate of cardiac death (%)|0.78|||||2-Sided|95.0|0.46|1.23|||||||
1702400|NCT00954707|3130455|Superiority or Other||Rate of major bleeding complications (%)|3.07|||||2-Sided|95.0|2.4|3.85|||||||
1702401|NCT00954707|3130456|Superiority or Other||Rate of ARC defined ST (%)|1.12|||||2-Sided|95.0|0.74|1.64|||||||
1702402|NCT00954707|3130457|Superiority or Other||Rate of protocol defined ST (%)|0.91|||||2-Sided|95.0|0.56|1.38|||||||
1702403|NCT00954707|3130458|Superiority or Other||Rate of MACE (%)|7.41|||||2-Sided|95.0|6.37|8.55|||||||
1702404|NCT00954707|3130459|Superiority or Other||Rate of Target vessel failure (%)|7.92|||||2-Sided|95.0|6.85|9.09|||||||
1702405|NCT00954707|3130460|Superiority or Other||Rate of Clinically-driven TVR (%)|5.8|||||2-Sided|95.0|4.87|6.81|||||||
1702406|NCT00954707|3130461|Superiority or Other||Rate of Clinically-driven TLR (%)|4.2|||||2-Sided|95.0|3.45|5.13|||||||
1702407|NCT00954707|3130462|Superiority or Other||Rate of procedure success (%)|97.7|||||2-Sided|95.0|97.0|98.2|||||||
1702408|NCT00954707|3130463|Superiority or Other||Rate of lesion success (%)|99.8|||||2-Sided|95.0|99.6|99.9|||||||
1702409|NCT00954707|3130464|Superiority or Other||Rate of device success (%)|98.0|||||2-Sided|95.0|97.4|98.4|||||||
1702410|NCT00954707|3130465|Superiority or Other||Rate of TLF at 12-month (%)|6.4|||||2-Sided|95.0|5.5|7.5|||||||
1702411|NCT00954538|3130467|Superiority or Other||LS Mean Difference|0.12|||||2-Sided|90.0|-0.04|0.27|||||Difference = AD group value - HE group value|A 90% confidence interval was calculated for the group difference (AD - HE) using the model results. As prespecified by the analysis plan, if the lower bound of the 90% confidence interval is above 0, then the hypothesis that [18F]MK-3328 can discriminate between AD patients and cognitively normal elderly controls as measured by regional tracer uptake following single IV doses of [18F]MK-3328 is supported.|
1702412|NCT00954538|3130468|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1702413|NCT00954447|3130475|Superiority or Other||Odds Ratio (OR)|4.327|||<|0.0001||95.0|2.221|8.43|||Regression, Logistic|Logistic regression of HbA1c < 6.5 percent at week 52|Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment|FAS with baseline HbA1c >= 6.5 percent (NCF); there are 615 available values for Placebo and 616 for Linagliptin 5mg|
1702414|NCT00954447|3130478|Superiority or Other||Mean Difference (Final Values)|-1.58|Standard Error of the Mean|0.53||0.0029||95.0|-2.61|-0.54|||ANCOVA||Linagliptin 5mg - Placebo||
1702415|NCT00954447|3130481|Superiority or Other||Mean Difference (Final Values)|-11.6|Standard Error of the Mean|2.49|<|0.0001||95.0|-16.49|-6.71|||ANCOVA||Linagliptin 5mg - Placebo||
1702416|NCT00954447|3130482|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.05|<|0.0001||95.0|-0.64|-0.43|||ANCOVA||Linagliptin 5mg - Placebo||
1702417|NCT00954447|3130483|Superiority or Other||Mean Difference (Final Values)|-0.55|Standard Error of the Mean|0.05|<|0.0001||95.0|-0.65|-0.45|||ANCOVA||Linagliptin 5mg - Placebo||
1702418|NCT00954447|3130484|Superiority or Other||Mean Difference (Final Values)|-0.57|Standard Error of the Mean|0.05|<|0.0001||95.0|-0.67|-0.47|||ANCOVA||Linagliptin 5mg - Placebo||
1702419|NCT00954447|3130485|Superiority or Other||Mean Difference (Final Values)|-0.67|Standard Error of the Mean|0.05|<|0.0001||95.0|-0.76|-0.57|||ANCOVA||Linagliptin 5mg - Placebo||
1702420|NCT00954447|3130486|Superiority or Other||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.04|<|0.0001||95.0|-0.69|-0.52|||ANCOVA||Linagliptin 5mg - Placebo||
1702421|NCT00954447|3130487|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.03|<|0.0001||95.0|-0.51|-0.39|||ANCOVA||Linagliptin 5mg - Placebo||
1702422|NCT00954447|3130489|Superiority or Other||Odds Ratio (OR)|2.935|||<|0.0001||95.0|1.949|4.419|||Regression, Logistic|Logistic regression of HbA1c < 7.0 percent at week 52|Linagliptin 5mg vs. Placebo OR adjusted for baseline HbA1c, categorical renal function impairment, concomitant OADs and treatment|FAS with baseline HbA1c >= 7.0 percent (NCF); there are 593 available values for Placebo and 595 for Linagliptin 5mg|
1702423|NCT00954447|3130490|Superiority or Other||Mean Difference (Final Values)|-0.65|Standard Error of the Mean|0.05|<|0.0001||95.0|-0.74|-0.55|||ANCOVA||Linagliptin 5mg - Placebo||
1702424|NCT00954421|3130491|Superiority or Other||Mean Difference (Net)|0.73|Standard Deviation|8.49||0.68||95.0|-4.96|6.42|||two-sided sign rank test|two sided sign rank test as pre-planned||The null hypothesis is that difference in change in Tremor Rating Scale (TRS) score from baseline to 6 months when VO is on and VIM is off, versus when VIM is on and VO is off, will be zero (i.e., that there will be no difference in effect between having exclusively VIM versus VO on)|
1702425|NCT00954421|3130491|Superiority or Other||Mean Difference (Net)|8.4|Standard Deviation|9.1||0.011|2-Sided|95.0|2.2|14.5||Sign rank test was pre-planned for P-value|Sign-Rank test||p-value assessed using sign rank test|The null hypothesis is that difference in change in Tremor Rating Scale (TRS) score from baseline to 6 months when both stimulators are on (VIM and VO), versus when both stimulators are off, will be zero (i.e., that there will be no difference in effect between having both stimulators on versus both stimulators off)|
1702426|NCT00954421|3130492|Superiority or Other||Mean Difference (Net)|-17.6|Standard Deviation|19.4||0.026|2-Sided|95.0|-30.61|-4.65|||two-sided sign-rank test||p-value assessed via sign-rank test (pre-planned method)|The null hypothesis is that the mean change in Tremor Rating Scale score from baseline to six months post-implant (with VIM and VO stimulators turned ON) will be zero|
1702427|NCT00954109|3130513|Superiority or Other||||||<|0.05|||||||t-test, 1 sided||||
1702428|NCT00954109|3130514|Superiority or Other||||||<|0.05|||||||t-test, 1 sided||||
1702429|NCT00953849|3130525|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|A Student’s t test was performed to determine significance of differences between each of two groups.|||
1702430|NCT00953849|3130526|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|A Student’s t test was performed to determine significance of differences between each of two groups.|||
1702431|NCT00953849|3130527|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|A Student’s t test was performed to determine significance of differences between each of two groups.|||
1702432|NCT00953849|3130528|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|A Student's t test was performed to determine significance of differences between each of two groups.|||
1702433|NCT00953745|3130529|Superiority or Other|||||||0.366|||||||t-test, 2 sided||||
1702434|NCT00953745|3130529|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1702435|NCT00953745|3130530|Superiority or Other|||||||0.029||||||paired t-test thresholded at cluster level significance of p=0.001; family-wise error multiple comparisons corrected|t-test, 1 sided|||A region of increased relative Fluorodopa (FDOPA) uptake in the right medial caudate was anticipated for the aripiprazole augmentation responders over the 6 weeks of augmentation treatment (Weeks 10-16).|
1702436|NCT00953719|3130532|Superiority or Other||Mean Difference (Net)|0.079||||0.952||95.0|||||Mixed Models Analysis|SAS PROC MIXED was used with an ante-dependence covariance structure.||A repeated measurements longitudinal model of Harris Hip scores was carried out to compare Harris Hip results between treatment groups across time.|
1702437|NCT00953719|3130538|Non-Inferiority or Equivalence|The prospectively planned primary endpoint analysis was a non-inferiority test of covariate adjusted 24 month or later Harris Hip score means with a 5 point non-inferiority margin. A prospective power analysis with an anticipated Harris Hip score standard deviation of 10.08 (for both treatment groups) indicated that sample sizes of 134 and 67 would provide approximately 95% statistical power for this non-inferiority test with a type 1 error rate of 5%.|Mean Difference (Final Values)|0.7|Standard Error of the Mean|1.24|<|0.001|1-Sided|95.0|-1.4||||ANCOVA||||
1702438|NCT00953706|3130548|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.5||0.7265|2-Sided|95.0|-1.1|0.7|||Mixed Models Analysis|||The analysis used the linear mixed model with treatment as fixed effects, visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group (< 18 years and ≥ 18 years) and percent predicted forced expiratory volume (FEV1) severity (< 70%, ≥ 70% to ≤ 90%, > 90%) at screening, with random intercept and random slope. Rate of change in the study period is the slope of weight versus time (days) multiplied by the number of days in the study period (112 days).|
1702439|NCT00953706|3130549|Superiority or Other||Mean Difference (Final Values)|-2.9|Standard Error of the Mean|1.4||0.0384|2-Sided|95.0|-5.6|-0.2|||Mixed Models Analysis|||Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable being absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous age and baseline value for age, sweat chloride, using unstructured covariance matrix.|
1702440|NCT00953706|3130550|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|2.1||0.5408|2-Sided|95.0|-2.9|5.6|||Mixed Models Analysis|||Analysis for the respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with the dependent variable being absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for for age and baseline value for CFQ-R score, using unstructured covariance matrix|
1702441|NCT00953706|3130551|Superiority or Other||Mean Difference (Final Values)|1.7|Standard Error of the Mean|1.2||0.1509|2-Sided|95.0|-0.6|4.1|||Mixed Models Analysis|||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit as fixed effects, and participant as a random effect, with adjustment for age and continuous baseline value of percent predicted FEV1.|
1702442|NCT00953680|3130552|Non-Inferiority or Equivalence|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.931||||||90.0|0.836|1.037||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule|
1702443|NCT00953680|3130553|Non-Inferiority or Equivalence|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.924||||||90.0|0.825|1.035||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule|
1702444|NCT00953680|3130554|Non-Inferiority or Equivalence|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.835||||||90.0|0.749|0.931||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100-mg tablet + HCTZ 12.5 mg capsule|
1702445|NCT00953680|3130555|Non-Inferiority or Equivalence|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.993||||||90.0|0.95|1.039||||||Least-Squares Mean Ratio (A/B); A= Single dose losartan 100 mg-HCTZ 12.5 mg combination tablet; B= Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule|
1702446|NCT00953654|3130558|Superiority or Other||||||<|0.05|||||||ANCOVA|The degrees of freedom were adjusted when the sphericity assumption was violated based on Mauchly's test.||Effects of RET and AET were compared to WL using a 3 condition by 3 time ANCOVA. An a priori statistical power analysis showed that a sample of 30 patients would provide a statistical power of .80 to detect a condition-by-time interaction for PSWQ scores assuming a two-tailed alpha value of 0.05, a correlation across repeated measures of 0.75 and a desire to detect a standardized effect size of 0.65.|
1702447|NCT00953199|3130597|Superiority or Other|||||||0.45||||||.05 was set as level of significance|Chi-squared|||We calculated the sample size to be 570 in each arm, providing 80% power, allocation 1:1, two-sided, alpha 0.05, withdrawal rate of 3% and a reduction in pancreatitis from 8% to 4%. Randomization is performed with permuted blocks of 20. Analysis is based on intention to treat.|
1702448|NCT00953147|3130614|Superiority or Other||Median Difference (Final Values)|0.42||||0.0122|2-Sided|95.0|0.12|0.72|||ANCOVA|||Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons|
1702449|NCT00953147|3130614|Superiority or Other||Mean Difference (Final Values)|0.58||||0.0014|2-Sided|95.0|0.25|0.92|||ANCOVA|||Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons|
1702450|NCT00953147|3130615|Superiority or Other||Mean Difference (Final Values)|0.54||||0.0005|2-Sided|95.0|0.24|0.84||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.|
1702451|NCT00953147|3130615|Superiority or Other||Mean Difference (Final Values)|0.69|||<|0.0001|2-Sided|95.0|0.35|1.04||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in iTNSS with a two-sided alpha level of 0.025.|
1702452|NCT00952822|3130648|Non-Inferiority or Equivalence|Bioequivalence limits of -0.223 to 0.223 in accordance with FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence; 2001.|Difference of Least-Squares Means|-0.016||||||90.0|-0.076|0.043|||||||
1702453|NCT00952822|3130649|Non-Inferiority or Equivalence|Bioequivalence limits of -0.223 to 0.223 in accordance with FDA Guidance for Industry: Statistical Approaches to Establishing Bioequivalence; 2001.|Difference of Least-Squares Means|-0.052||||||90.0|-0.117|0.012|||||||
1702454|NCT00952718|3130661|Superiority|||||||0.269|||||||Regression, Linear||||
1702455|NCT00952718|3130662|Superiority|||||||0.063|||||||Regression, Linear||||
1702456|NCT00952718|3130663|Superiority|||||||0.038||||||adjusted p for MEP by linear regression|Regression, Linear||||
1702457|NCT00952718|3130663|Superiority|||||||0.005||||||p-value for MIP was adjusted by linear regression model.|Regression, Linear||||
1702458|NCT00952705|3130691|Non-Inferiority or Equivalence|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Victoria GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj > 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Victoria post-dose GMT ratio: FluMist B/Victoria divided by Q/LAIV-BFS B/Victoria.|Ratio of geometric mean titers|0.97|||||2-Sided|95.0|0.87|1.1||||||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antigen measurements were calculated as: GMT = antilog^y (mean [log^y x]) where x was the assay result and y was the natural logarithm.|
1702459|NCT00952705|3130691|Non-Inferiority or Equivalence|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose B/Yamagata GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj > 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Yamagata post-dose GMT ratio: FluMist B/Yamagata divided by Q/LAIV-BFS B/Yamagata.|Ratio of geometric mean titers|0.9|||||2-Sided|95.0|0.79|1.02||||||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antigen measurements were calculated as: GMT = antilog^y (mean [log^y x]) where x was the assay result and y was the natural logarithm.|
1702482|NCT00952367|3130760|Superiority or Other||Odds Ratio (OR)|0.438|||<|0.019|2-Sided|95.0|0.221|0.871|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=5.538||Birth information, preterm birth vs full-term birth|
1702460|NCT00952705|3130691|Non-Inferiority or Equivalence|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H3N2 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj > 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H3N2 post-dose GMT ratio: (FluMist B/Yamagata A/H3N2 + FluMist B/Victoria A/H3N2) divided by Q/LAIV-BFS A/H3N2.|Ratio of geometric mean titers|0.93|||||2-Sided|95.0|0.85|1.0||||||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antigen measurements were calculated as: GMT = antilog^y (mean [log^y x]) where x was the assay result and y was the natural logarithm.|
1702461|NCT00952705|3130691|Non-Inferiority or Equivalence|The immune response of Q/LAIV-BFS was declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for the post dose A/H1N1 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj > 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H1N1 post-dose GMT ratio: (FluMist B/Yamagata A/H1N1 + FluMist B/Victoria A/H1N1) divided by Q/LAIV-BFS A/H1N1.|Ratio of geometric mean titers|0.95|||||2-Sided|95.0|0.87|1.03||||||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CIs for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antigen measurements were calculated as: GMT = antilog^y (mean [log^y x]) where x was the assay result and y was the natural logarithm.|
1702462|NCT00952653|3130694|Superiority or Other||ratio of adjusted geometric means|87.39|||||2-Sided|90.0|80.42|94.96|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference)|
1702463|NCT00952653|3130697|Superiority or Other||ratio of adjusted geometric means|72.1|||||2-Sided|90.0|66.04|78.72|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference)|
1702464|NCT00952653|3130698|Superiority or Other||ratio of adjusted geometric means|101.17|||||2-Sided|90.0|92.96|110.11|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction [that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam], where overall study power is to be based on the product of the individual powers of the parameters of interest.|
1702465|NCT00952653|3130699|Superiority or Other||ratio of adjusted geometric means|92.55|||||2-Sided|90.0|87.43|97.97|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction [that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam], where overall study power is to be based on the product of the individual powers of the parameters of interest.|
1702466|NCT00952653|3130700|Superiority or Other||ratio of adjusted geometric means|86.08|||||2-Sided|90.0|79.04|93.74|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction [that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam], where overall study power is to be based on the product of the individual powers of the parameters of interest.|
1702467|NCT00952653|3130701|Superiority or Other||ratio of adjusted geometric means|71.4|||||2-Sided|90.0|65.08|78.33|||||Values have been back-transformed from the log scale.|DVS SR + Midazolam (test) versus Midazolam (reference). Based on the sample size, this study has at least 85% power overall to demonstrate the lack of an interaction [that is, equivalence in both AUCinf and Cmax and both midazolam and 1-hydroxy midazolam], where overall study power is to be based on the product of the individual powers of the parameters of interest.|
1702468|NCT00952484|3130718|Superiority or Other|||||||0.0007||||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided||||
1702469|NCT00952484|3130719|Superiority or Other||||||<|0.0001||||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided||||
1702470|NCT00952484|3130720|Superiority or Other|||||||0.757||||||P-value testing whether the mean change from Baseline differs from Zero based on a Wilcoxon Signed-Rank test.|Wilcoxon Signed-Rank||||
1702471|NCT00952484|3130721|Superiority or Other|||||||0.7417||||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided||||
1702472|NCT00952484|3130722|Superiority or Other|||||||0.0789||||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided||||
1702473|NCT00952484|3130723|Superiority or Other|||||||0.0097||||||P-value testing whether the mean change from Baseline differs from Zero based on a t-test.|t-test, 2 sided||||
1702474|NCT00952484|3130724|Superiority or Other|||||||0.0007||||||P-value based on Wilcoxon rank sum test comparing the median RGI-C score for the asfotase alfa combined reporting group to the historical control group.|Wilcoxon (Mann-Whitney)||||
1702475|NCT00952367|3130760|Superiority or Other||Odds Ratio (OR)|0.666||||0.001|2-Sided|95.0|0.52|0.855|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=10.233||Whether have brothers or sisters, no vs yes|
1702476|NCT00952367|3130760|Superiority or Other||Odds Ratio (OR)|1.233||||0.122|2-Sided|95.0|0.439|3.464|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=2.395||Mother's education level, college/university vs postgraduate or above|
1702477|NCT00952367|3130760|Superiority or Other||Odds Ratio (OR)|1.907||||0.298|2-Sided|95.0|0.679|5.353|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.081||Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above|
1702478|NCT00952367|3130760|Superiority or Other||Odds Ratio (OR)|1.972||||0.193|2-Sided|95.0|0.699|5.562|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.691||Mother's education level, junior middle school vs graduate or above|
1702479|NCT00952367|3130760|Superiority or Other||Odds Ratio (OR)|1.793||||0.626|2-Sided|95.0|0.596|5.394|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.238||Mother's education level, elementary school vs graduate or above|
1702480|NCT00952367|3130760|Superiority or Other||Odds Ratio (OR)|2.137||||0.559|2-Sided|95.0|0.473|9.652|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.341||Mother's education level, illiteracy vs graduate or above|
1702481|NCT00952367|3130760|Superiority or Other||Odds Ratio (OR)|0.546|||<|0.001|2-Sided|95.0|0.423|0.703|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=21.938||Household register, local vs nonlocal|
1702483|NCT00952367|3130761|Superiority or Other||Odds Ratio (OR)|0.729||||0.064|2-Sided|95.0|0.522|1.018|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.432||Vaccination history of Hib, no vs yes|
1702484|NCT00952367|3130761|Superiority or Other||Odds Ratio (OR)|0.984||||0.056|2-Sided|95.0|0.968|1.0|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.648||Living space per capita, continuous variables|
1702485|NCT00952367|3130761|Superiority or Other||Odds Ratio (OR)|3.029||||0.077|2-Sided|95.0|0.412|22.292|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.131||Father's education level, college/university vs postgraduate or above|
1702486|NCT00952367|3130761|Superiority or Other||Odds Ratio (OR)|3.513||||0.179|2-Sided|95.0|0.474|26.03|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.807||Father's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above|
1702487|NCT00952367|3130761|Superiority or Other||Odds Ratio (OR)|4.83||||0.756|2-Sided|95.0|0.649|35.956|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.096||Father's education level, junior high school vs postgraduate or above|
1702488|NCT00952367|3130761|Superiority or Other||Odds Ratio (OR)|4.671||||0.778|2-Sided|95.0|0.537|40.608|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.079||Father's education level, elementary school vs postgraduate or above|
1702489|NCT00952367|3130761|Superiority or Other||Odds Ratio (OR)|92.229||||0.006|2-Sided|95.0|3.993|2130.5|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=7.438||Father's education level, illiteracy vs postgraduate or above|
1702490|NCT00952367|3130761|Superiority or Other||Odds Ratio (OR)|0.707||||0.038|2-Sided|95.0|0.42|1.191|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.316||Feeding manners within 6 months, mixed feeding vs pure formula milk feeding|
1702491|NCT00952367|3130761|Superiority or Other||Odds Ratio (OR)|1.182||||0.044|2-Sided|95.0|0.758|1.844|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.074||Feeding manners within 6 months, pure breast feeding vs pure formula milk feeding|
1702492|NCT00952367|3130761|Superiority or Other||Odds Ratio (OR)|0.666||||0.04|2-Sided|95.0|0.451|0.981|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.228||Household register, local vs nonlocal|
1702493|NCT00952367|3130761|Superiority or Other||Odds Ratio (OR)|0.255||||0.057|2-Sided|95.0|0.062|1.044|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.610||Birth information, preterm birth vs full-term birth|
1702494|NCT00952367|3130762|Superiority or Other||Odds Ratio (OR)|0.516|||<|0.001|2-Sided|95.0|0.4|0.666|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=25.960||Whether have brothers or sisters, no vs yes|
1702495|NCT00952367|3130762|Superiority or Other||Odds Ratio (OR)|0.58|||<|0.175|2-Sided|95.0|0.1|3.347|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.838|||
1702496|NCT00952367|3130762|Superiority or Other||Odds Ratio (OR)|1.06|||<|0.364|2-Sided|95.0|0.344|3.267|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.824||Family monthly income per capita, 5000 to 7999 RMB vs >=10000 RMB|
1702497|NCT00952367|3130762|Superiority or Other||Odds Ratio (OR)|1.983|||<|0.021|2-Sided|95.0|0.704|5.583|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=5.313||Family monthly income per capita, 2000 to 4999 RMB vs >=10000 RMB|
1702498|NCT00952367|3130762|Superiority or Other||Odds Ratio (OR)|2.089|||<|0.01|2-Sided|95.0|0.739|5.906|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=6.549||Family monthly income per capita, 600 to 1999 RMB vs >=10000 RMB|
1702499|NCT00952367|3130762|Superiority or Other||Odds Ratio (OR)|2.217|||<|0.043|2-Sided|95.0|0.719|6.831|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=4.095||Family monthly income per capita, <=600 RMB vs >=10000 RMB|
1702500|NCT00952367|3130762|Superiority or Other||Odds Ratio (OR)|1.306|||<|0.001|2-Sided|95.0|0.399|4.277|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=13.525||Mother's education level, college/university vs postgraduate or above|
1702501|NCT00952367|3130762|Superiority or Other||Odds Ratio (OR)|2.321|||<|0.662|2-Sided|95.0|0.71|7.589|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=0.191||Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above|
1702502|NCT00952367|3130762|Superiority or Other||Odds Ratio (OR)|3.064|||<|0.159|2-Sided|95.0|0.933|10.067|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=1.984||Mother's education level, junior middle school vs postgraduate or above|
1702503|NCT00952367|3130762|Superiority or Other||Odds Ratio (OR)|3.443|||<|0.102|2-Sided|95.0|1.001|11.843|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=2.671||Mother's education level, elementary school vs postgraduate or above|
1702504|NCT00952367|3130762|Superiority or Other||Odds Ratio (OR)|7.369|||<|0.006|2-Sided|95.0|1.672|32.479|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=7.524||Mother's education level, illiteracy vs postgraduate or above|
1702505|NCT00952367|3130762|Superiority or Other||Odds Ratio (OR)|0.793|||<|0.06|2-Sided|95.0|0.622|1.01|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=3.529||Household register, local vs nonlocal|
1702506|NCT00952367|3130762|Superiority or Other||Odds Ratio (OR)|1.641|||<|0.001|2-Sided|95.0|1.247|2.159|||Chi-squared|Degrees of freedom=1, Wald Chi-Square=12.514||Age of mother bearing, <=30 years vs >30 years|
1702507|NCT00952341|3130772|Superiority or Other|||||||0.001|||||||Regression, Logistic|||Adjusted by gender and concomitant chemotherapy.|
1702508|NCT00952341|3130773|Superiority or Other|||||||0.882|||||||Regression, Logistic|||Adjusted by gender and concomitant chemotherapy.|
1702509|NCT00952341|3130774|Superiority or Other|||||||0.003|||||||Regression, Logistic|||"Adjusted by gender and concomitant~chemotherapy."|
1702510|NCT00952341|3130775|Superiority or Other|||||||0.001|||||||Regression, Logistic|||"Adjusted by gender and concomitant chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."|
1702511|NCT00952341|3130776|Superiority or Other|||||||0.942|||||||Regression, Logistic|||"Adjusted by gender and concomitant chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."|
1702512|NCT00952341|3130777|Superiority or Other|||||||0.007|||||||Regression, Logistic|||"Adjusted by gender and concomitant~chemotherapy.~The apriori significance level was set at 0.05.~There was no adjustment for multiplicity."|
1702513|NCT00952289|3130798|Superiority or Other||||||<|0.0001|||||||Fisher Exact|||The primary endpoint analyzed with a 2-sided alpha of 0.05.|
1702514|NCT00952120|3130812|Superiority or Other|||||||0.8|||||||Regression, Logistic|robust standard errors were used to account for the multiple observations per patient|||
1702515|NCT00951912|3130819|Superiority or Other||Mean Difference (Net)|-106.2|Standard Error of the Mean|82.2|<|0.05|2-Sided|95.0|-305.1|92.8|||ANOVA||||
1702516|NCT00951912|3130819|Superiority or Other||Mean Difference (Net)|-3.8|Standard Error of the Mean|82.6|<|0.05|2-Sided|95.0|-203.7|196.1|||ANOVA||||
1702517|NCT00951912|3130819|Superiority or Other||Mean Difference (Net)|102.4|Standard Error of the Mean|83.4|<|0.05|2-Sided|95.0|-99.3|304.1|||ANOVA||||
1702518|NCT00951912|3130820|Superiority or Other||Mean Difference (Net)|-0.4503|Standard Error of the Mean|0.1163|<|0.05|2-Sided|95.0|-0.6804|-0.2202|||ANOVA||||
1702519|NCT00951912|3130820|Superiority or Other||Mean Difference (Net)|-0.606|Standard Error of the Mean|0.119|<|0.05|2-Sided|95.0|-0.8414|-0.3707|||ANOVA||||
1702520|NCT00951912|3130820|Superiority or Other||Mean Difference (Net)|-0.1557|Standard Error of the Mean|0.119|<|0.05||95.0|-0.3911|0.0796|||ANOVA||||
1702521|NCT00951912|3130821|Superiority or Other||Mean Difference (Net)|0.6635|Standard Error of the Mean|0.1121|<|0.05|2-Sided|95.0|0.4419|0.8851|||ANOVA||||
1702522|NCT00951912|3130821|Superiority or Other||Mean Difference (Net)|0.0282|Standard Error of the Mean|0.1156|<|0.05|2-Sided|95.0|-0.2003|0.2568|||ANOVA||||
1702523|NCT00951912|3130821|Superiority or Other||Mean Difference (Net)|-0.6353|Standard Error of the Mean|0.1146|<|0.05|2-Sided|95.0|-0.8617|-0.4089|||ANOVA||||
1702524|NCT00951912|3130822|Superiority or Other||Mean Difference (Net)|0.2451|Standard Error of the Mean|0.09648|<|0.05|2-Sided|95.0|0.0544|0.4358|||ANOVA||||
1702525|NCT00951912|3130822|Superiority or Other||Mean Difference (Net)|-0.1986|Standard Error of the Mean|0.09986|<|0.05|2-Sided|95.0|-0.3956|-0.0016|||ANOVA||||
1702526|NCT00951912|3130822|Superiority or Other||Mean Difference (Net)|-0.4437|Standard Error of the Mean|0.1001|<|0.05|2-Sided|95.0|-0.6416|-0.2458|||ANOVA||||
1702527|NCT00951912|3130823|Superiority or Other||Mean Difference (Net)|-2.7837|Standard Error of the Mean|4.1309|<|0.05|2-Sided|95.0|-12.7767|7.2092|||ANOVA||||
1702528|NCT00951912|3130823|Superiority or Other||Mean Difference (Net)|-0.7716|Standard Error of the Mean|4.1501|<|0.05|2-Sided|95.0|-10.8111|9.2679|||ANOVA||||
1702529|NCT00951912|3130823|Superiority or Other||Mean Difference (Net)|2.0122|Standard Error of the Mean|4.1686|<|0.05|2-Sided|95.0|-8.0721|12.0964|||ANOVA||||
1702530|NCT00951912|3130824|Superiority or Other||Mean Difference (Net)|-0.7909|Standard Error of the Mean|3.205|<|0.05|2-Sided|95.0|-8.5442|6.9624|||ANOVA||||
1702531|NCT00951912|3130824|Superiority or Other||Mean Difference (Net)|1.0276|Standard Error of the Mean|3.2199|<|0.05|2-Sided|95.0|-6.7619|8.817|||ANOVA||||
1702532|NCT00951912|3130824|Superiority or Other||Mean Difference (Net)|1.8185|Standard Error of the Mean|3.2343|<|0.05|2-Sided|95.0|-6.0057|9.6426|||ANOVA||||
1702533|NCT00951912|3130825|Superiority or Other||Mean ranks|1.031|||<|0.05|||||||Kruskal-Wallis||||
1702534|NCT00951912|3130826|Superiority or Other||Mean Difference (Net)|0.0439|Standard Error of the Mean|4.8669|<|0.05|2-Sided|95.0|-11.7296|11.8174|||ANOVA||||
1702535|NCT00951912|3130826|Superiority or Other||Mean Difference (Net)|3.4809|Standard Error of the Mean|4.8896|<|0.05|2-Sided|95.0|-8.3475|15.3092|||ANOVA||||
1702536|NCT00951912|3130826|Superiority or Other||Mean Difference (Net)|3.437|Standard Error of the Mean|4.9113|<|0.05|2-Sided|95.0|-8.444|15.318|||ANOVA||||
1702537|NCT00951912|3130827|Superiority or Other||Mean Ranks|2.169|||<|0.05|||||||Kruskal-Wallis||||
1702538|NCT00951912|3130828|Superiority or Other||Mean Ranks|1.895|||<|0.05|||||||Kruskal-Wallis||||
1702539|NCT00951912|3130829|Superiority or Other||Mean Rank|1.442|||<|0.05|||||||Kruskal-Wallis||||
1702540|NCT00951912|3130830|Superiority or Other||Median Difference (Net)|1.9689|Standard Error of the Mean|3.12126|<|0.05|2-Sided|95.0|-5.5817|9.5195|||ANOVA||||
1702541|NCT00951912|3130830|Superiority or Other||Odds Ratio, log|-0.9972|Standard Error of the Mean|3.13581|<|0.05|2-Sided|95.0|-8.583|6.5886|||ANOVA||||
1702542|NCT00951912|3130830|Superiority or Other||Mean Difference (Net)|-2.9661|Standard Error of the Mean|3.14977|<|0.05|2-Sided|95.0|-10.5857|4.6535|||ANOVA||||
1702543|NCT00951912|3130831|Superiority or Other||Mean Difference (Net)|-2.67485|Standard Error of the Mean|1.44646|<|0.05|2-Sided|95.0|-6.174|0.8243|||ANOVA||||
1702544|NCT00951912|3130831|Superiority or Other||Mean Difference (Net)|-2.68659|Standard Error of the Mean|1.4532|<|0.05|2-Sided|95.0|-6.202|0.8288|||ANOVA||||
1702545|NCT00951912|3130831|Superiority or Other||Mean Difference (Net)|-0.01174|Standard Error of the Mean|1.45967|<|0.05|2-Sided|95.0|-3.5428|3.5194|||ANOVA||||
1702546|NCT00951912|3130832|Superiority or Other||Mean Difference (Net)|2.4626|Standard Error of the Mean|4.1624|<|0.05|2-Sided|95.0|-7.6067|12.5318|||ANOVA||||
1702547|NCT00951912|3130832|Superiority or Other||Mean Difference (Net)|0.6929|Standard Error of the Mean|4.1818|<|0.05|2-Sided|95.0|-9.4232|10.8091|||ANOVA||||
1702548|NCT00951912|3130832|Superiority or Other||Mean Difference (Net)|-1.7696|Standard Error of the Mean|4.2|<|0.05|2-Sided|95.0|-11.9308|8.3916|||ANOVA||||
1702549|NCT00951912|3130833|Superiority or Other||Mean Difference (Net)|3.8823|Standard Error of the Mean|2.399|<|0.05|2-Sided|95.0|-1.9234|9.6881|||ANOVA||||
1702550|NCT00951912|3130833|Superiority or Other||Mean Difference (Net)|3.0842|Standard Error of the Mean|2.411|<|0.05|2-Sided|95.0|-2.7486|8.9171|||ANOVA||||
1702551|NCT00951912|3130833|Superiority or Other||Mean Difference (Net)|-0.7981|Standard Error of the Mean|2.422|<|0.05|2-Sided|95.0|-6.6569|5.0607|||ANOVA|||"Null hypothesis: There are no difference in the difference of changes in plasma glucose.~Power calculation: The sample size of 55 subjects per group provided about 90% power to detect a significant change in the FG concentration of 8 mg/dL (7%) by using a general assumption of a 2-tailed a level of 0.05 and allowing for a 20% withdrawal rate."|
1702552|NCT00951899|3130841|Superiority or Other|||||||0.3|||||||t-test, 2 sided|||Comparison of mean total GLP-1 concentration from baseline to 12 weeks in Placebo subjects|
1702553|NCT00951899|3130841|Superiority or Other|||||||0.0006||||||A P value < 0.05 was considered statistically significant|t-test, 2 sided|||Comparison of mean total GLP-1 concentration from baseline to 12 weeks in Colesevelam subjects|
1702554|NCT00951821|3130843|Superiority or Other||Slope|0.4||||0.75|2-Sided|95.0|-2.36|3.06|||Mixed Models Analysis||The statistic provided (0.4) is the difference in the change in BDI score from baseline to follow-up by treatment group.||
1702555|NCT00951821|3130844|Superiority or Other||Slope|-3.3||||0.46|2-Sided|95.0|-12.1|5.5||Effect sizes were also calculated due to small sample size|Mixed Models Analysis||The reported statistic (-3.3) is the difference in the change from baseline to follow-up between the two treatment arms, estimated in a mixed effect regression model.||
1702556|NCT00951808|3130845|Superiority or Other||optimal threshold level of sPLA2|48.0|Standard Deviation|5.0|||2-Sided|95.0|38.0|58.0|||||The optimal threshold level (TL) was determined to be the same for all analysis groups.|The optimal threshold level (TL), determined via receiver operating characteristic (ROC) curve analysis, maximizes the difference between the true positive rate (TPR) and the false positive rate (FPR). Since there is no corresponding analytic standard deviation (SD) for this value, we computed a robust SD based upon the interquartile range (IQR)/1.35 from a bootstrap sample of optimal TLs.|
1702557|NCT00951561|3130868|Non-Inferiority or Equivalence|The sample size calculation is performed in nQuery version 5.0 with the following stipulations: alpha is 0.05; response for both ibuprofen and Vipon is 85%; delta is 10%; no difference in response rates is expected between the two treatment arms, and power is 80%. This calculation is performed for an equivalence/non-inferiority primary analysis.|Difference in % of Uses from Mixed Model|-1.6|||<|0.05||95.0|||||Mixed Models Analysis||||
1702558|NCT00951496|3130876|Non-Inferiority or Equivalence (legacy)|Study was designed to provide 80% power when arm III reduced the true progression free survival event rate. 20% compared to arm I. Critical p value accounts for correlation between 2 primary hypotheses.|Hazard Ratio (HR)|0.99||||0.587|2-Sided|95.0|0.86|1.15||P value not adjusted for multiplicity. Significance threshold = 0.027 accounting for 2 correlated primary hypotheses.|Log Rank|Stratified by stage of disease and size of residual disease.|Progression free survival hazard of arm III to arm I. Adjusted for stage of disease and residual disease size.|P value from a log rank test comparing the progression free survival hazards of arm III to arm I.|
1702559|NCT00951496|3130876|Non-Inferiority or Equivalence (legacy)|Study was designed to provide 80% power when arm II reduces the progression free survival event rate 20%. The critical p-value accounts for correlation between 2 primary hypotheses.|Hazard Ratio (HR)|0.94||||0.341|2-Sided|95.0|0.81|1.09||P value not adjusted for multiplicity. Significance Threshold = 0.027|Log Rank|Stratified by stage of disease and size of residual disease.|Progression free survival of arm II relative to arm I. Adjusted for stage of disease and residual size.|P value.(an P value is used to determine statistical significance in a hypothesis test). from a stratified log rank test to assess equality of progression free survival hazards of arm II and arm I|
1702560|NCT00951483|3130877|Superiority or Other||z-score|-3.911|||<|0.001|2-Sided||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline PSS-14 score and end of treatment (i.e., 12 week) PSS-14 score.|
1702561|NCT00951483|3130878|Superiority or Other||z-score|-4.435|||<|0.001|2-Sided||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline BDI score and end of treatment (i.e., 12 week) BDI score.|
1702562|NCT00951483|3130879|Superiority or Other||z-score|-4.51|||<|0.001|2-Sided||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-A score and end of treatment (i.e., 12 week) HAM-A score.|
1702563|NCT00951483|3130880|Superiority or Other||z-score|-4.624|||<|0.001|2-Sided||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-21 score and end of treatment (i.e., 12 week) HAMD-21 score.|
1702564|NCT00951483|3130881|Superiority or Other||z-score|-4.627|||<|0.001|2-Sided||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-17 score and end of treatment (i.e., 12 week) HAMD-17 score.|
1702565|NCT00951483|3130882|Superiority or Other||z-score|-4.544|||<|0.001|2-Sided||||||Wilcoxon signed rank test|||The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-D-7 score and end of treatment (i.e., 12 week) HAM-D-7 score.|
1702566|NCT00951483|3130883|Superiority or Other||Standardized test statistic (z-score)|-2.65||||0.001|2-Sided||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that C-reactive protein (CRP) is no different between the experimental and healthy control cohorts at 12 weeks.|
1702567|NCT00951093|3130927|Superiority or Other||||||<|0.001|||||||Friedman´s test|followed by nonparametric pairwise multiple comparisons|||
1702568|NCT00951093|3130928|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons|||
1702569|NCT00951093|3130929|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons|||
1702570|NCT00951093|3130930|Superiority or Other||||||<|0.02|||||||Wilcoxon (Mann-Whitney)|followed by nonparametric pairwise multiple comparisons|||
1702571|NCT00951093|3130931|Superiority or Other||||||<|0.001|||||||Friedman´s test||||
1702572|NCT00951093|3130932|Superiority or Other|||||||0.002|||||||Friedman´s test|followed by nonparametric pairwise multiple comparisons|||
1702573|NCT00951093|3130933|Superiority or Other||||||<|0.001||||||P value adjusted for multiple comparisons|Friedman´s test|followed by nonparametric pairwise multiple comparisons|||
1702574|NCT00950937|3131018|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|Paired t-test was utilized to compare the two groups (HIV group and Control group)|||
1702575|NCT00950937|3131019|Superiority or Other||||||<|0.05|||||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences|||
1702576|NCT00950937|3131019|Superiority or Other||||||<|0.05|||||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences|||
1702577|NCT00950937|3131019|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.|||
1702578|NCT00950937|3131020|Superiority or Other||||||<|0.05|||||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences|||
1702579|NCT00950937|3131020|Superiority or Other||||||<|0.05|||||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences|||
1702580|NCT00950937|3131020|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.|||
1702755|NCT00949533|3131386|Superiority or Other|||||||1|||||||Fisher Exact|||Sore throat: statistical difference between 2 groups was based on fisher-exact test.|
1702581|NCT00950937|3131021|Superiority or Other||||||<|0.05|||||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences|||
1702582|NCT00950937|3131021|Superiority or Other||||||<|0.05|||||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences|||
1702583|NCT00950937|3131021|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.|||
1702584|NCT00950937|3131022|Superiority or Other||||||<|0.05|||||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences|||
1702585|NCT00950937|3131022|Superiority or Other||||||<|0.05|||||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences|||
1702586|NCT00950937|3131022|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.|||
1702587|NCT00950937|3131023|Superiority or Other||||||<|0.05|||||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences|||
1702588|NCT00950937|3131023|Superiority or Other||||||<|0.05|||||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences|||
1702589|NCT00950937|3131023|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.|||
1702590|NCT00950937|3131024|Superiority or Other||||||<|0.05|||||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences|||
1702591|NCT00950937|3131024|Superiority or Other||||||<|0.05|||||||Friedman Test|Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences|||
1702592|NCT00950937|3131024|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.|||
1702593|NCT00950859|3131047|Superiority or Other||percentage of participants|96.0||||||95.0|79.0|100.0|||||The estimated value represents the percentage of participants with HIV-1 RNA <400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.||
1702594|NCT00950859|3131047|Superiority or Other||percentage of participants|78.0|||||2-Sided|95.0|58.0|91.0|||||The estimated value represents the percentage of participants with HIV-1 RNA <400 c/mL or at least 0.7 log10 c/mL below their Baseline value at Day 11.||
1702595|NCT00950833|3131074|Non-Inferiority|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 23F.|GMC ratio for anti-23F|36.52|||||2-Sided|95.0|27.59|48.34||||||To demonstrate the immunological memory for anti-pneumococcal serotype 23F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.|
1702596|NCT00950833|3131074|Non-Inferiority|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 19F.|GMC ratio for anti-19F|9.25|||||2-Sided|95.0|7.29|11.74||||||To demonstrate the immunological memory for anti-pneumococcal serotype 19F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.|
1702597|NCT00950833|3131074|Non-Inferiority|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 18C.|GMC ratio for anti-18C|10.01|||||2-Sided|95.0|7.95|12.61||||||To demonstrate the immunological memory for anti-pneumococcal serotype 18C induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.|
1702598|NCT00950833|3131074|Non-Inferiority|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 14.|GMC ratio for anti-14|22.92|||||2-Sided|95.0|17.51|30.0||||||To demonstrate the immunological memory for anti-pneumococcal serotype 14 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.|
1702599|NCT00950833|3131074|Non-Inferiority|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 9V.|GMC ratio for anti-9V|14.1|||||2-Sided|95.0|11.21|17.75||||||To demonstrate the immunological memory for anti-pneumococcal serotype 9V induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.|
1702623|NCT00950300|3131247|Other||Hazard Ratio (HR)|0.98||||0.8651|2-Sided|95.0|0.74|1.29|||Log Rank||HR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).||
1702624|NCT00950300|3131250|Other||Odds Ratio (OR)|0.86|||||2-Sided|95.0|0.5|1.46|||||OR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).||
1702600|NCT00950833|3131074|Non-Inferiority|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 7F.|GMC ratio for anti-7F|4.75|||||2-Sided|95.0|3.9|5.78||||||To demonstrate the immunological memory for anti-pneumococcal serotype 7F induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.|
1702601|NCT00950833|3131074|Non-Inferiority|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 6B.|GMC ratio for anti-6B|28.81|||||2-Sided|95.0|22.54|36.81||||||To demonstrate the immunological memory for anti-pneumococcal serotype 6B induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.|
1702602|NCT00950833|3131074|Non-Inferiority|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 5.|GMC ratio for anti-5|13.47|||||2-Sided|95.0|10.96|16.55||||||To demonstrate the immunological memory for anti-pneumococcal serotype 5 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.|
1702603|NCT00950833|3131074|Non-Inferiority|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled SynflorixI+II Group over Synflorix Group) was higher than 1 for pneumococcal serotype 4.|GMC ratio for anti-4|2.86|||||2-Sided|95.0|2.38|3.45||||||To demonstrate the immunological memory for anti-pneumococcal serotype 4 induced following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.|
1702604|NCT00950833|3131074|Non-Inferiority|The immune memory would be demonstrated if the lower limit (LL) of the 95% confidence interval (CI) around the geometric mean concentration (GMC) ratios (Pooled Synflorix I+II Group over Synflorix III Group) was higher than 1 for pneumococcal serotype 1.|GMC ratio for anti-1|6.17|||||2-Sided|95.0|5.03|7.58||||||To demonstrate the immunological memory induced for anti-pneumococcal serotype 1 following primary vaccination in study 107017 (NCT00370318) and booster vaccination in study 107137 (NCT00496015) with the Synflorix™ vaccine, through evaluation of early antibody responses after an additional dose of Synflorix™ vaccine at 40-48 months of age, compared to the Synflorix III Group.|
1702605|NCT00950807|3131077|Superiority or Other||Mean Difference (Final Values)|0.105||||0.003|2-Sided|95.0|0.037|0.173|||Mixed Models Analysis||||
1702606|NCT00950807|3131077|Superiority or Other||Mean Difference (Final Values)|0.172|||<|0.001|2-Sided|95.0|0.101|0.242|||Mixed Models Analysis||||
1702607|NCT00950807|3131077|Superiority or Other||Mean Difference (Final Values)|0.134|||<|0.001|2-Sided|95.0|0.064|0.204|||Mixed Models Analysis||||
1702608|NCT00950807|3131077|Superiority or Other||Mean Difference (Final Values)|0.079|||<|0.03|2-Sided|95.0|0.008|0.151|||Mixed Models Analysis||||
1702609|NCT00950807|3131077|Superiority or Other||Mean Difference (Final Values)|0.186|||<|0.001|2-Sided|95.0|0.113|0.259|||Mixed Models Analysis||||
1702610|NCT00950807|3131077|Superiority or Other||Mean Difference (Final Values)|0.14|||<|0.001|2-Sided|95.0|0.074|0.205|||Mixed Models Analysis||||
1702611|NCT00950807|3131077|Superiority or Other||Mean Difference (Final Values)|0.095|||<|0.006|2-Sided|95.0|0.027|0.162|||Mixed Models Analysis||||
1702612|NCT00950807|3131077|Superiority or Other||Mean Difference (Final Values)|0.147|||<|0.001|2-Sided|95.0|0.077|0.216|||Mixed Models Analysis||||
1702613|NCT00950807|3131077|Superiority or Other||Mean Difference (Final Values)|0.128|||<|0.001|2-Sided|95.0|0.06|0.196|||Mixed Models Analysis||||
1702614|NCT00950755|3131094|Superiority or Other||percentage of participants|10.0|||||2-Sided|95.0|1.0|19.0|||||The estimated value represents the percentage of participants with confirmed PR.||
1702615|NCT00950755|3131095|Superiority or Other||percentage of participants|41.0|||||2-Sided|95.0|26.0|57.0|||||The estimated value represents the percentage of participants with confirmed CR + CCR.||
1702616|NCT00950755|3131096|Superiority or Other||percentage of participants|34.0|||||2-Sided|95.0|20.0|49.0|||||The estimated value represents the percentage of participants with confirmed CR.||
1702617|NCT00950755|3131097|Superiority or Other||percentage of participants|54.0|||||2-Sided|95.0|38.0|69.0|||||The estimated value represents the percentage of participants with confirmed response.||
1702618|NCT00950755|3131098|Superiority or Other||percentage of participants|76.0|||||2-Sided|95.0|62.0|89.0|||||The estimated value represents the percentage of participants with response.||
1702619|NCT00950664|3131117|Non-Inferiority or Equivalence|81 participants required to detect 5 difference in Tsui score, with 80% power. 20% drop out rate assumed, 102 participants needed. Alpha level of 0.05.||||||0.05|||||||Paired-t test||||
1702620|NCT00950599|3131237|Superiority or Other|||||||0.9888||||||Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort.|ANCOVA|ANCOVA Model: post-pre=pretreatment. Contrast Coefficients: -2, -1, 0, 1 2.|||
1702621|NCT00950599|3131238|Superiority or Other|||||||0.9888||||||A significance level of alpha = 0.05 was used for the trend test.|Kruskal-Wallis|ANCOVA Model: post-pre=pre treatment.||A test for log-linear trend across saxagliptin doses was performed using a linear contrast among the saxagliptin doses from an analysis of covariance (ANCOVA) model. The ANCOVA model was the same model used for the first secondary endpoint.|
1702622|NCT00950300|3131245|Other||Hazard Ratio (HR)|0.94||||0.7767|2-Sided|95.0|0.61|1.45|||Log Rank||HR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).||
1702625|NCT00950300|3131250|Other||Difference in response rates|-1.64|||||2-Sided|95.0|-7.4|4.2|||||The 95% CI for the difference in response (CR+PR) rates was calculated using the Anderson-Hauck continuity correction.||
1702626|NCT00950300|3131251|Other||Difference in response rates|5.01|||||2-Sided|95.0|-3.5|13.5|||||The 95% CI for the difference in response (tpCR) rates was calculated using the Anderson-Hauck continuity correction.||
1702627|NCT00950300|3131260|Other||Geometric mean ratio|1.55|||||2-Sided|90.0|1.45|1.64|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.|
1702628|NCT00950300|3131261|Other||Geometric mean ratio|1.55|||||2-Sided|90.0|1.46|1.64|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.|
1702629|NCT00950300|3131262|Other||Geometric mean ratio|1.51|||||2-Sided|90.0|1.4|1.63|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|Additional supportive analysis.|
1702630|NCT00950300|3131263|Non-Inferiority|Non-inferiority was concluded if the lower limit of the one-sided 97.5% CI was above -12.5% for the difference in response (pCR) rates.|Difference in response rates|4.7|||||1-Sided|97.5|-4.0||||||The one-sided 97.5% CI for the difference in response (pCR) rates was calculated using the Anderson-Hauck continuity correction.|Assuming pCR rates of at least 40% in both arms, 552 participants were necessary to conclude non-inferiority in pCR rate with a power of 80% using a one-sided 97.5% CI for the difference of the response rates and a non-inferiority margin of 12.5%.|
1702631|NCT00950300|3131264|Non-Inferiority|Non-inferiority was concluded if the lower limit of the 90% confidence interval (CI) was greater than or equal to (≥) 0.8 for the geometric mean ratio.|Geometric mean ratio|1.33|||||2-Sided|90.0|1.24|1.44|||||Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).|PK sample size calculations based on percentage of coefficient of variation (CV%) for Ctrough of trastuzumab from previous metastatic breast cancer (MBC) and early breast cancer (EBC) studies. Because pre-surgery situation was comparable to MBC setting, interpatient CV% of 60 percent (%) was assumed and 130 participants per arm (260 participants total) were needed to demonstrate Ctrough comparability with 80% power if the true means of the two formulations did not differ by greater than (>) 5%.|
1702632|NCT00949884|3131340|Superiority or Other||Mean Difference (Final Values)|-8.6|||<|0.0001|2-Sided|95.0|-12.5|-4.7|||ANCOVA|Treatment is a fixed effect and baseline blood pressure is a covariate.||Systolic blood pressure|
1702633|NCT00949884|3131340|Superiority or Other||Mean Difference (Final Values)|-4.3|||<|0.0009|2-Sided|95.0|-6.8|-1.8|||ANCOVA|Treatment is a fixed effect and baseline blood pressure is a covariate.||Diastolic blood pressure|
1702634|NCT00949884|3131341|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.0434|2-Sided|95.0|-5.0|-0.1|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure|
1702635|NCT00949884|3131341|Superiority or Other||Mean Difference (Final Values)|-2.8||||0.0279|2-Sided|95.0|-5.3|-0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure|
1702636|NCT00949884|3131341|Superiority or Other||Mean Difference (Final Values)|-3.2||||0.0767|2-Sided|95.0|-6.8|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure|
1702637|NCT00949884|3131341|Superiority or Other||Mean Difference (Final Values)|-3.5||||0.0552|2-Sided|95.0|-7.1|0.1|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure|
1702638|NCT00949884|3131341|Superiority or Other||Mean Difference (Final Values)|-2.6||||0.0497|2-Sided|95.0|-5.2|0.0|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure|
1702639|NCT00949884|3131341|Superiority or Other||Mean Difference (Final Values)|-3.0||||0.0249|2-Sided|95.0|-5.6|-0.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure|
1702640|NCT00949884|3131341|Superiority or Other||Mean Difference (Final Values)|-3.1||||0.1011|2-Sided|95.0|-6.9|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure|
1702641|NCT00949884|3131341|Superiority or Other||Mean Difference (Final Values)|-3.6||||0.062|2-Sided|95.0|-7.3|0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure|
1702642|NCT00949884|3131341|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.1778|2-Sided|95.0|-4.9|0.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure|
1702643|NCT00949884|3131341|Superiority or Other||Mean Difference (Final Values)|-2.3||||0.1328|2-Sided|95.0|-5.2|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure|
1702644|NCT00949884|3131341|Superiority or Other||Mean Difference (Final Values)|-2.3||||0.2701|2-Sided|95.0|-6.5|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure|
1702645|NCT00949884|3131341|Superiority or Other||Mean Difference (Final Values)|-2.8||||0.1895|2-Sided|95.0|-7.0|1.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure|
1702646|NCT00949884|3131342|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.2011|2-Sided|95.0|-3.7|0.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure|
1702647|NCT00949884|3131342|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.17|2-Sided|95.0|-3.8|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour diastolic blood pressure|
1702648|NCT00949884|3131342|Superiority or Other||Mean Difference (Final Values)|-1.8||||0.2558|2-Sided|95.0|-5.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure|
1702649|NCT00949884|3131342|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.2461|2-Sided|95.0|-5.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||6 hour systolic blood pressure|
1702650|NCT00949884|3131342|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.2314|2-Sided|95.0|-3.7|0.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure|
1702651|NCT00949884|3131342|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.1621|2-Sided|95.0|-3.9|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour diastolic blood pressure|
1702652|NCT00949884|3131342|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.3133|2-Sided|95.0|-5.0|1.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure|
1702653|NCT00949884|3131342|Superiority or Other||Mean Difference (Final Values)|-1.8||||0.2708|2-Sided|95.0|-5.1|1.4|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||4 hour systolic blood pressure|
1702654|NCT00949884|3131342|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.1799|2-Sided|95.0|-4.3|0.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure|
1702655|NCT00949884|3131342|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.1277|2-Sided|95.0|-4.5|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour diastolic blood pressure|
1702656|NCT00949884|3131342|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.3863|2-Sided|95.0|-5.1|2.0|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure|
1702657|NCT00949884|3131342|Superiority or Other||Mean Difference (Final Values)|-1.8||||0.3229|2-Sided|95.0|-5.4|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||2 hour systolic blood pressure|
1702658|NCT00949884|3131343|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.0942|2-Sided|95.0|-4.4|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure|
1702659|NCT00949884|3131343|Superiority or Other||Mean Difference (Final Values)|-2.1||||0.09|2-Sided|95.0|-4.5|0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure|
1702660|NCT00949884|3131343|Superiority or Other||Mean Difference (Final Values)|-3.0||||0.0926|2-Sided|95.0|-6.4|0.5|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure|
1702661|NCT00949884|3131343|Superiority or Other||Mean Difference (Final Values)|-3.0||||0.0988|2-Sided|95.0|-6.5|0.6|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure|
1702662|NCT00949884|3131343|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.0363|2-Sided|95.0|-4.7|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure|
1702663|NCT00949884|3131343|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.0324|2-Sided|95.0|-4.8|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure|
1702664|NCT00949884|3131343|Superiority or Other||Mean Difference (Final Values)|-3.5||||0.0345|2-Sided|95.0|-6.8|-0.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure|
1702665|NCT00949884|3131343|Superiority or Other||Mean Difference (Final Values)|-3.5||||0.0396|2-Sided|95.0|-6.8|-0.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure|
1702666|NCT00949884|3131344|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.4259|2-Sided|95.0|-3.0|1.3|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure|
1702667|NCT00949884|3131344|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.3929|2-Sided|95.0|-3.1|1.2|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime diastolic blood pressure|
1702668|NCT00949884|3131344|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.4039|2-Sided|95.0|-4.5|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure|
1702669|NCT00949884|3131344|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.4362|2-Sided|95.0|-4.4|1.9|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Nighttime systolic blood pressure|
1702670|NCT00949884|3131344|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.1654|2-Sided|95.0|-3.9|0.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure|
1702671|NCT00949884|3131344|Superiority or Other||Mean Difference (Final Values)|-1.8||||0.1197|2-Sided|95.0|-4.1|0.5|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime diastolic blood pressure|
1702672|NCT00949884|3131344|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.3653|2-Sided|95.0|-4.9|1.8|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure|
1702673|NCT00949884|3131344|Superiority or Other||Mean Difference (Final Values)|-1.8||||0.3104|2-Sided|95.0|-5.2|1.7|||ANCOVA|Treatment was a fixed effect and baseline mean daytime and nighttime ABPM blood pressure was a covariate.||Daytime systolic blood pressure|
1702674|NCT00949884|3131345|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.0177|2-Sided|95.0|-4.4|-0.4|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in diastolic blood pressure.|
1705477|NCT00911508|3136679|Superiority||Cox Proportional Hazard|0.83|||||2-Sided|95.0|0.74|0.93|||||||
1702675|NCT00949884|3131345|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.0175|2-Sided|95.0|-4.5|-0.4|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in diastolic blood pressure.|
1702676|NCT00949884|3131345|Superiority or Other||Mean Difference (Final Values)|-3.6||||0.0186|2-Sided|95.0|-6.6|-0.6|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in systolic blood pressure.|
1702677|NCT00949884|3131345|Superiority or Other||Mean Difference (Final Values)|-3.6||||0.0209|2-Sided|95.0|-6.6|-0.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 8 in systolic blood pressure.|
1702678|NCT00949884|3131346|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.2542|2-Sided|95.0|-3.0|0.8|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 4 in diastolic blood pressure.|
1702679|NCT00949884|3131346|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.2085|2-Sided|95.0|-3.2|0.7|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure is a covariate.||Change from baseline at week 4 in diastolic blood pressure.|
1702680|NCT00949884|3131346|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.3491|2-Sided|95.0|-4.4|1.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.||Change from baseline at week 4 in systolic blood pressure.|
1702681|NCT00949884|3131346|Superiority or Other||Mean Difference (Final Values)|-1.5||||0.325|2-Sided|95.0|-4.4|1.5|||ANCOVA|Treatment is a fixed effect and baseline mean 24-hour ABPM blood pressure as a covariate.||Change from baseline at week 4 in systolic blood pressure.|
1702682|NCT00949884|3131347|Superiority or Other|||||||0.0657|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of <120/80 mmHg|
1702683|NCT00949884|3131347|Superiority or Other|||||||0.0476|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of <120/80 mmHg|
1702684|NCT00949884|3131347|Superiority or Other|||||||0.0594|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of <130/80 mmHg|
1702685|NCT00949884|3131347|Superiority or Other|||||||0.0589|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates||Percentage of participants achieving blood pressure goal of <130/80 mmHg|
1702686|NCT00949884|3131347|Superiority or Other|||||||0.0063|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of <135/80 mmHg|
1702687|NCT00949884|3131347|Superiority or Other|||||||0.0047|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of <135/80 mmHg|
1702688|NCT00949884|3131347|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of <140/90 mmHg|
1702689|NCT00949884|3131347|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of <140/90 mmHg|
1702690|NCT00949884|3131347|Superiority or Other||||||<|0.0096|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of <80 mmHg|
1702691|NCT00949884|3131347|Superiority or Other||||||<|0.0061|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of <80 mmHg|
1702692|NCT00949884|3131347|Superiority or Other||||||<|0.0066|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of <85 mmHg|
1702693|NCT00949884|3131347|Superiority or Other||||||<|0.007|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of <85 mmHg|
1702694|NCT00949884|3131347|Superiority or Other||||||<|0.0003|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of <90 mmHg|
1702695|NCT00949884|3131347|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of <90 mmHg|
1702696|NCT00949884|3131347|Superiority or Other||||||<|0.0605|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <120 mmHg|
1702697|NCT00949884|3131347|Superiority or Other||||||<|0.0519|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <120 mmHg|
1702698|NCT00949884|3131347|Superiority or Other||||||<|0.028|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <130 mmHg|
1702699|NCT00949884|3131347|Superiority or Other||||||<|0.0347|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <130 mmHg|
1702756|NCT00949533|3131386|Superiority or Other|||||||0.284|||||||Chi-squared|||Rhinorrhea: statistical difference between 2 groups was based on chi-squared test.|
1702700|NCT00949884|3131347|Superiority or Other||||||<|0.0007|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <135 mmHg|
1702701|NCT00949884|3131347|Superiority or Other||||||<|0.0009|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <135 mmHg|
1702702|NCT00949884|3131347|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <140 mmHg|
1702703|NCT00949884|3131347|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <140 mmHg|
1702704|NCT00949884|3131348|Superiority or Other|||||||0.0012|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of <130/80 mmHg|
1702705|NCT00949884|3131348|Superiority or Other|||||||0.0023|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of <130/80 mmHg|
1702706|NCT00949884|3131348|Superiority or Other|||||||0.0004|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of <135/80 mmHg|
1702707|NCT00949884|3131348|Superiority or Other|||||||0.0005|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of <135/80 mmHg|
1702708|NCT00949884|3131348|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of <140/90 mmHg|
1702709|NCT00949884|3131348|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving blood pressure goal of <140/90 mmHg|
1702710|NCT00949884|3131348|Superiority or Other||||||<|0.0011|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of <80 mmHg|
1702711|NCT00949884|3131348|Superiority or Other||||||<|0.001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of <80 mmHg|
1702712|NCT00949884|3131348|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of <85 mmHg|
1702713|NCT00949884|3131348|Superiority or Other||||||<|0.0001||||||The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.|Regression, Logistic|||Percentage of participants achieving diastolic blood pressure goal of <85 mmHg|
1702714|NCT00949884|3131348|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of <90 mmHg|
1702715|NCT00949884|3131348|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving diastolic blood pressure goal of <90 mmHg|
1702716|NCT00949884|3131348|Superiority or Other||||||<|0.1646|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <120 mmHg|
1702717|NCT00949884|3131348|Superiority or Other||||||<|0.2755|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <120 mmHg|
1702718|NCT00949884|3131348|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <130 mmHg|
1702719|NCT00949884|3131348|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <130 mmHg|
1702720|NCT00949884|3131348|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <135 mmHg|
1702721|NCT00949884|3131348|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <135 mmHg|
1702722|NCT00949884|3131348|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <140 mmHg|
1702723|NCT00949884|3131348|Superiority or Other||||||<|0.0001|||||||Regression, Logistic|The p-value is from the logistic regression with treatment as the main effect and baseline SSBP or SDBP as covariates.||Percentage of participants achieving systolic blood pressure goal of <140 mmHg|
1702724|NCT00949884|3131349|Superiority or Other||Mean Difference (Final Values)|-1.5|Standard Error of the Mean|0.9||0.0979|2-Sided|95.0|-3.2|0.3|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.|||
1702754|NCT00949533|3131386|Superiority or Other|||||||1|||||||Fisher Exact|||Shortness of breath: statistical difference between 2 groups was based on fisher-exact test.|
1702725|NCT00949884|3131349|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.92||0.2312|2-Sided|95.0|-2.9|0.7|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.|||
1702726|NCT00949884|3131350|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.54||0.0783|2-Sided|95.0|-2.0|0.1|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.|||
1702727|NCT00949884|3131350|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.55||0.1121|2-Sided|95.0|-2.0|0.2|||ANCOVA|Treatment as a fixed effect and the seated cuff diastolic blood pressure value at week 4 (with last observation carried forward) as a covariate.|||
1702728|NCT00949884|3131352|Superiority or Other||Mean Difference (Final Values)|-2.7|Standard Error of the Mean|0.58|<|0.0001|2-Sided|95.0|-3.8|-1.5|||ANCOVA|ANCOVA model included treatment as a fixed effect and baseline blood pressure value as a covariate.|||
1702729|NCT00949884|3131353|Superiority or Other||Mean Difference (Final Values)|-3.9|Standard Error of the Mean|0.99||0.0001|2-Sided|95.0|-5.8|-1.9|||ANCOVA|The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.|||
1702730|NCT00949884|3131354|Superiority or Other||Mean Difference (Final Values)|-3.6|Standard Error of the Mean|0.88|<|0.0001|2-Sided|95.0|-5.3|-1.8|||ANCOVA|The ANCOVA model included treatment as a fixed effect and baseline SSBP as a covariate.|||
1702731|NCT00949884|3131355|Superiority or Other||Mean Difference (Final Values)|-2.5|Standard Error of the Mean|0.63|<|0.0001|2-Sided|95.0|-3.8|-1.3|||ANCOVA|The ANCOVA model included treatment as a fixed effect and the baseline DBP as a covariate.||Null hypothesis was that there was no difference in change in seated diastolic blood pressure from baseline to end of treatment. Sample size of 900, this study had 90% power to detect a true difference in mean change from baseline in mean trough SDBP of 2.0 mmHg for Combined Olmesartan vs Losartan.|
1702732|NCT00949715|3131356|Superiority or Other||Mean Difference (Net)|9.9||||0.9835||95.0||||Adjusting for age and gender|Wilcoxon (Mann-Whitney)|Rank Sum||Ho: The AT/AF burden in the RVS group is the same as the RVA group.|
1702733|NCT00949715|3131357|Superiority or Other||Mean Difference (Net)|-11.3||||0.1051|2-Sided|95.0|-25.1|2.4|||t-test, 2 sided|||Ho: Pacing at selective sites (RVS or RVA) has no different impact on LV end systolic volume|
1702734|NCT00949715|3131358|Superiority or Other||Mean Difference (Net)|-1.1||||0.7405|2-Sided|95.0|-7.6|5.5|||t-test, 2 sided|||Ho: Packing at selective RV sites (mid-Septum or apex) has no different impact on LVEF change from 2 weeks to 24 months.|
1702735|NCT00949715|3131359|Superiority or Other||Mean Difference (Final Values)|4.0||||0.2352|2-Sided|95.0|-2.7|10.8|||t-test, 2 sided|||HO: Pacing at selective RV sites (mid-septum or apex) has no different impact on the change in LVEF after 24 months follow-up. With 12% SD and 80 subjects in groups will have 90% power to detect an absolute difference in LVEF of 6.2% at 24 months follow-up at an alpha level of 0.05.|
1702736|NCT00949650|3131375|Superiority or Other||Hazard Ratio (HR)|0.826||||0.0427||95.0|0.618|1.104|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR<1 then favours Afatinib 40 mg.||
1702737|NCT00949650|3131375|Superiority or Other|||||||0.1882||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank||||
1702738|NCT00949650|3131376|Superiority or Other||Hazard Ratio (HR)|0.68||||0.0078||95.0|0.499|0.927|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR<1 then favours Afatinib 40 mg.||
1702739|NCT00949650|3131376|Superiority or Other|||||||0.0129||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank||||
1702740|NCT00949650|3131377|Superiority or Other||Hazard Ratio (HR)|0.589||||0.2133||95.0|0.401|0.866|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg vs. Pemetrexed/Cisplatin Chemotherapy, if HR<1 then favours Afatinib 40 mg.||
1702741|NCT00949650|3131377|Superiority or Other|||||||0.0062||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank||||
1702742|NCT00949650|3131380|Superiority or Other||Mean Difference (Final Values)|-9.82|||<|0.0001||95.0|-13.64|-5.99|||ANCOVA|Adjusted for baseline SoD, EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.||
1702743|NCT00949650|3131381|Superiority or Other||Hazard Ratio (HR)|0.88||||0.385||95.0|0.66|1.174|||Regression, Cox|Cox PH regression stratified by EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.||
1702744|NCT00949650|3131381|Superiority or Other|||||||0.7916||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank||||
1702745|NCT00949650|3131382|Superiority or Other||Odds Ratio (OR)|2.288||||0.0118||95.0|1.202|4.356|||Regression, Logistic|Logistic regression stratified for EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.||
1702746|NCT00949650|3131383|Superiority or Other||Odds Ratio (OR)|4.802|||<|0.0001||95.0|2.855|8.075|||Regression, Logistic|Logistic regression stratified for EGFR mutation group and race.|Afatinib 40 mg-Pemetrexed/Cisplatin Chemotherapy.||
1702747|NCT00949650|3131384|Superiority or Other||Hazard Ratio (HR)|0.576||||0.0002||95.0|0.426|0.778|||Regression, Cox|Cox Proportional Hazard (PH) regression stratified by epidermal growth factor receptor (EGFR) mutation group and race.|Afatinib 40 mg versus Pemetrexed/Cisplatin Chemotherapy.||
1702748|NCT00949650|3131384|Superiority or Other|||||||0.0002||||||Two-sided p-value from log-rank test stratified by EGFR mutation group and race.|Log Rank||||
1702749|NCT00949533|3131386|Superiority or Other|||||||0.106|||||||Fisher Exact|||Other: statistical difference between 2 groups was based on fisher-exact test.|
1702750|NCT00949533|3131386|Superiority or Other|||||||1|||||||Fisher Exact|||Vomiting: statistical difference between 2 groups was based on fisher-exact test.|
1702751|NCT00949533|3131386|Superiority or Other|||||||1|||||||Fisher Exact|||Conjunctivitis: statistical difference between 2 groups was based on fisher-exact test.|
1702752|NCT00949533|3131386|Superiority or Other|||||||0.593|||||||Fisher Exact|||Headache: statistical difference between 2 groups was based on fisher-exact test.|
1702753|NCT00949533|3131386|Superiority or Other|||||||0.487|||||||Fisher Exact|||Diarrhea: statistical difference between 2 groups was based on fisher-exact test.|
1705478|NCT00911508|3136680|Superiority||Cox Proportional Hazard|0.85|||||2-Sided|95.0|0.6|1.21|||||||
1702757|NCT00949533|3131386|Superiority or Other|||||||1|||||||Chi-squared|||Cough: statistical difference between 2 groups was based on chi-squared test.|
1702758|NCT00949533|3131387|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1702759|NCT00949533|3131388|Superiority or Other|||||||0.825|||||||Pearson Chi-Square||||
1702760|NCT00949234|3131401|Other||||||<|0.05|||||||Chi-squared|||There was no power calculation for this analysis. The study was mainly descriptive, but Chi-square tests were used to determine if there were differences between individuals who were retained at the 24 Week Follow-up visit from individuals who were not retained at the 24 Week Follow-up visit.|
1702761|NCT00948896|3131425|Superiority or Other||Protective Efficacy (%)|69.0|||<|0.001|2-Sided|95.0|53.0|80.0||Adjusted for age at randomization and incidence of malaria prior to randomization.|Negative Binomial Regression||Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.|
1702762|NCT00948896|3131425|Superiority or Other||Protective Efficacy (%)|49.0|||<|0.001|2-Sided|95.0|23.0|66.0||Adjusted for age at randomization and incidence of malaria prior to randomization.|Negative Binomial Regression||Adjusted for age at randomization and incidence of malaria prior to randomization. The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.|
1702763|NCT00948896|3131425|Superiority or Other||Protective Efficacy (%)|9.0|||<|0.065|2-Sided|95.0|-35.0|38.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|We assumed that the incidence of malaria would be 1.85 episodes per person year with TS based on a prior cohort study in the same area, and thus, that we would need to enroll 50 participants in each arm to detect a reduction in the incidence of malaria in either the monthly SP or DP arms (two-sided significance level 0.05) compared with the daily TS arm of 48% or greater with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.|
1702764|NCT00948896|3131426|Superiority or Other||Protective Efficacy (%)|58.0|||<|0.001|2-Sided|95.0|45.0|67.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.|
1702765|NCT00948896|3131426|Superiority or Other||Protective Efficacy (%)|28.0|||<|0.01|2-Sided|95.0|7.0|44.0|||Negative Binomial Regression||The no chemoprevention arm is the reference arm.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.|
1702766|NCT00948896|3131426|Superiority or Other||Protective Efficacy (%)|7.0|||<|0.57|2-Sided|95.0|-19.0|28.0|||Negative Binomial Regression||The no chemoprevention arm is the reference group.|The sample size was calculated to detect at least a 32% lower incidence of malaria in the DP arm compared to that in the TS arm. We assumed that the incidence of malaria would be 1.85 episodes per person-year with TS chemoprevention based on a prior cohort study in the same area, and thus we calculated that we would need to enroll 100 participants in each arm to detect our targeted protective efficacy with 80% power at 95% significance (two-sided), allowing for 10% loss to follow-up.|
1702767|NCT00948896|3131428|Superiority or Other||||||<|0.01||||||Daily TS arm compare with the no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the daily TS arm|
1702768|NCT00948896|3131428|Superiority or Other||||||<|0.05||||||Monthly DP arm compared with the no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of elevated temperature adverse events per PYAR between the control arm and the monthly DP arm|
1702769|NCT00948896|3131428|Superiority or Other||||||<|0.05||||||Monthly DP arm compared with no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the monthly DP arm|
1702770|NCT00948896|3131428|Superiority or Other||||||<|0.05||||||Monthly DP arm compared with no chemoprevention arm.|Negative Binomial Regression|||Null Hypothesis: Within HIV-exposed participants, there is no difference in the incidence of all grade 3-4 adverse events per PYAR between the control arm and the monthly DP arm.|
1702771|NCT00948896|3131428|Superiority or Other||||||<|0.05||||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of thrombocytopenia adverse events per PYAR between the control arm and the monthly DP arm.|
1702772|NCT00948896|3131428|Superiority or Other||||||<|0.01||||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of anemia adverse events per PYAR between the control arm and the monthly DP arm.|
1702773|NCT00948896|3131428|Superiority or Other||||||<|0.01||||||Monthly DP arm compared to No chemoprevention arm|Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of elevated temperature adverse events per PYAR between the control arm and the monthly DP arm.|
1702848|NCT00946998|3131637|Superiority||||||>|0.77||||||For comparison of dialysis initiation between groups.|Chi-squared||||
1702774|NCT00948896|3131428|Superiority or Other||||||<|0.0001|||||||Negative Binomial Regression|||Null Hypothesis: Within HIV-unexposed participants, there is no difference in the incidence of all grade 3-4 adverse events per PYAR between the control arm and the monthly DP arm.|
1702775|NCT00948818|3131443|Superiority or Other||Odds Ratio (OR)|1.93|||<|0.0001|2-Sided|95.0|1.4|2.66||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 6/12 Week APC + 1 Responders.~The power, adjusted for multiplicity, was expected to be 86% based on NCT00460811 (MCP-103-202) study data."|
1702776|NCT00948818|3131444|Superiority or Other||Odds Ratio (OR)|1.41||||0.0262|2-Sided|95.0|1.04|1.91||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week Abdominal Pain Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."|
1702777|NCT00948818|3131445|Superiority or Other||Odds Ratio (OR)|3.65|||<|0.0001|2-Sided|95.0|2.26|5.88||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week CSBM 3 + 1 Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."|
1702778|NCT00948818|3131447|Superiority or Other||Odds Ratio (OR)|2.6||||0.0004|2-Sided|95.0|1.51|4.47||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week APC 3 + 1 Responders.~The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data."|
1702779|NCT00948792|3131448|Superiority or Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in the change in post-transfusion platelet counts (30 minutes and 6 hours post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."|
1702780|NCT00948792|3131449|Superiority or Other|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in post-transfusion platelet counts (6-hour post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."|
1702781|NCT00948792|3131450|Superiority or Other|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||"The null hypothesis is that there would be no difference in post-transfusion platelet counts (30-minutes post-transfusion) between the two groups.~We opted to determine the number of transfusions that would be required to detect difference of 20,000 platelets/mm3 (with a standard deviation of 20,000). The number shown to demonstrate this was 44."|
1702782|NCT00948675|3131465|Superiority or Other (legacy)|||||||0.575|||||||Pearson Chi-square Test||||
1702783|NCT00948675|3131466|Superiority or Other (legacy)|||||||0.414|||||||Pearson Chi-square Test||||
1702784|NCT00948675|3131467|Superiority or Other (legacy)|||||||0.615|||||||Log Rank||||
1702785|NCT00948675|3131468|Superiority or Other (legacy)|||||||0.61|||||||Log Rank||||
1702786|NCT00948675|3131469|Superiority or Other (legacy)|||||||0.176|||||||Log Rank||||
1702787|NCT00948441|3131475|Superiority or Other|||||||0.012|||||||t-test, 2 sided|||matched pairs T test to compare infection rates during the two study periods|
1702788|NCT00947882|3131503|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.5757|2-Sided|95.0|-1.773|0.987||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."||
1702789|NCT00947882|3131503|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.7906|2-Sided|95.0|-1.576|1.2||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."||
1702790|NCT00947882|3131503|Superiority or Other||Mean Difference (Final Values)|0.42||||0.5469|2-Sided|95.0|-0.956|1.802||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."||
1702791|NCT00947882|3131503|Superiority or Other||Mean Difference (Final Values)|0.07||||0.909|2-Sided|95.0|-1.113|1.25||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."||
1702792|NCT00947882|3131503|Superiority or Other||Mean Difference (Final Values)|0.29||||0.6331|2-Sided|95.0|-0.9|1.477||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."||
1702793|NCT00947882|3131503|Superiority or Other||Mean Difference (Final Values)|0.11||||0.8511|2-Sided|95.0|-1.068|1.294||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline Qmax as covariate and treatment group, region (North America,Europe) and prostate volume stratum (<30 mL,≥30 mL) as factors.LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."||
1702844|NCT00947310|3131598|Superiority or Other||Hazard Ratio (HR)|0.45||||0.01|2-Sided|95.0|0.24|0.85|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1|
1702794|NCT00947882|3131504|Superiority or Other||Mean Difference (Final Values)|-1.97||||0.6089|2-Sided|95.0|-9.513|5.581||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."||
1702795|NCT00947882|3131504|Superiority or Other||Mean Difference (Final Values)|-1.22||||0.7502|2-Sided|95.0|-8.768|6.322||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."||
1702796|NCT00947882|3131504|Superiority or Other||Mean Difference (Final Values)|-2.2||||0.5652|2-Sided|95.0|-9.729|5.322||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 6.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."||
1702797|NCT00947882|3131504|Superiority or Other||Mean Difference (Final Values)|-4.28||||0.2548|2-Sided|95.0|-11.65|3.096||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."||
1702798|NCT00947882|3131504|Superiority or Other||Mean Difference (Final Values)|-3.24||||0.3876|2-Sided|95.0|-10.614|4.128||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."||
1702799|NCT00947882|3131504|Superiority or Other||Mean Difference (Final Values)|-2.76||||0.4607|2-Sided|95.0|-10.113|4.59||No adjustment for multiple comparisons was made. Unadjusted p-value of comparison vs. placebo at Month 3.|ANCOVA|ANCOVA with baseline TPV as covariate and treatment group, region (North America,Europe) and prostate volume stratum (<30 mL,≥30 mL) as factors. LOCF.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."||
1702800|NCT00947882|3131505|Superiority or Other||Odds Ratio (OR)|1.27||||0.4263|2-Sided|95.0|0.702|2.308||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 6."||
1702801|NCT00947882|3131505|Superiority or Other||Odds Ratio (OR)|1.2||||0.538|2-Sided|95.0|0.667|2.174||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 6."||
1702802|NCT00947882|3131505|Superiority or Other||Odds Ratio (OR)|1.49||||0.1946|2-Sided|95.0|0.816|2.717||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 6."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 6."||
1702803|NCT00947882|3131505|Superiority or Other||Odds Ratio (OR)|1.1||||0.7586|2-Sided|95.0|0.609|1.975||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 5."||
1702804|NCT00947882|3131505|Superiority or Other||Odds Ratio (OR)|1.2||||0.5494|2-Sided|95.0|0.664|2.16||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 5."||
1702805|NCT00947882|3131505|Superiority or Other||Odds Ratio (OR)|1.28||||0.4206|2-Sided|95.0|0.706|2.304||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 5."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 5."||
1702806|NCT00947882|3131505|Superiority or Other||Odds Ratio (OR)|1.38||||0.2742|2-Sided|95.0|0.774|2.464||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 4."||
1702807|NCT00947882|3131505|Superiority or Other||Odds Ratio (OR)|1.81||||0.049|2-Sided|95.0|1.003|3.283||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 4."||
1702808|NCT00947882|3131505|Superiority or Other||Odds Ratio (OR)|1.77||||0.0587|2-Sided|95.0|0.979|3.184||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 4."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 4."||
1702845|NCT00946998|3131637|Superiority||||||>|0.99||||||For comparison of bleeding requiring blood transfusion or hospitalization.|Chi-squared||||
1702846|NCT00946998|3131637|Superiority||||||>|0.5||||||For comparison of acute suicidal intent.|Chi-squared||||
1702809|NCT00947882|3131505|Superiority or Other||Odds Ratio (OR)|1.75||||0.0658|2-Sided|95.0|0.964|3.195||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 10 mg and Placebo at Month 3."||
1702810|NCT00947882|3131505|Superiority or Other||Odds Ratio (OR)|1.5||||0.1748|2-Sided|95.0|0.834|2.71||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 20 mg and Placebo at Month 3."||
1702811|NCT00947882|3131505|Superiority or Other||Odds Ratio (OR)|1.46||||0.2034|2-Sided|95.0|0.814|2.628||"Adjustments were made for treatment group, baseline IPSS, graphical region (North America and Europe) and baseline prostate size (<30 mL and ≥30 mL).~Unadjusted p-value of comparison vs. placebo at Month 3."|Regression, Logistic|No adjustment for multiple comparisons was made. LOCF.|"Odds ratio of treatment response between Degarelix 30 mg and Placebo at Month 3."||
1702812|NCT00947882|3131506|Superiority or Other||Mean Difference (Final Values)|-0.84||||0.3132||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (<30 mL and ≥30 mL), and region (North America and Europe) as factors.|
1702813|NCT00947882|3131506|Superiority or Other||Mean Difference (Final Values)|-1.24||||0.1736||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (<30 mL and ≥30 mL), and region (North America and Europe) as factors.|
1702814|NCT00947882|3131506|Superiority or Other||Mean Difference (Final Values)|-1.15||||0.1562||||||P-values based on Williams' extended trend test of comparison vs. placebo at Month 6. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 6."|ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (<30 mL and ≥30 mL), and region (North America and Europe) as factors.|
1702815|NCT00947882|3131506|Superiority or Other||Mean Difference (Final Values)|-0.95||||0.2782||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (<30 mL and ≥30 mL), and region (North America and Europe) as factors.|
1702816|NCT00947882|3131506|Superiority or Other||Mean Difference (Final Values)|-1.54||||0.1083||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 5. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (<30 mL and ≥30 mL), and region (North America and Europe) as factors.|
1702817|NCT00947882|3131506|Superiority or Other||Mean Difference (Final Values)|-1.14||||0.1941||||||P-values based on Williams' extended trend test of comparisons vs. placebo at Month 5. No adjustment for multiple comparison was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 5."|ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (<30 mL and ≥30 mL), and region (North America and Europe) as factors.|
1702818|NCT00947882|3131506|Superiority or Other||Mean Difference (Final Values)|-1.11||||0.1638||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (<30 mL and ≥30 mL), and region (North America and Europe) as factors.|
1702819|NCT00947882|3131506|Superiority or Other||Mean Difference (Final Values)|-1.97||||0.0231||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (<30 mL and ≥30 mL), and region (North America and Europe) as factors.|
1702820|NCT00947882|3131506|Superiority or Other||Mean Difference (Final Values)|-1.62||||0.0367||||||P-values based on Williams' extended trend test of comparison vs. placebo at Month 4. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 4."|ANCOVA of the change from baseline in IPSS at Months 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (<30 mL and ≥30 mL), and region (North America and Europe) as factors.|
1702821|NCT00947882|3131507|Superiority or Other||Mean Difference (Final Values)|-0.92||||0.2342||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 10 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (<30 mL and ≥30 mL), and region (North America and Europe) as factors.|
1702822|NCT00947882|3131507|Superiority or Other||Mean Difference (Final Values)|-1.44||||0.0865|2-Sided|||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 20 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (<30 mL and ≥30 mL), and region (North America and Europe) as factors.|
1702823|NCT00947882|3131507|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.0911||||||P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made.|Step-down, Williams' extended trend test|Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate.|"Treatment difference between Degarelix 30 mg and Placebo at Month 3."|Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (<30 mL and ≥30 mL), and region (North America and Europe) as factors.|
1702824|NCT00947765|3131521|Superiority or Other|||||||0.0064|||||||Wilcoxon (Mann-Whitney)||||
1702825|NCT00947765|3131522|Superiority or Other|||||||0.0058|||||||Wilcoxon (Mann-Whitney)||||
1702826|NCT00947765|3131523|Superiority or Other|||||||0.0184|||||||Wilcoxon (Mann-Whitney)||||
1702827|NCT00947765|3131524|Superiority or Other|||||||0.0127|||||||Wilcoxon (Mann-Whitney)||||
1702828|NCT00947765|3131525|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)||||
1702829|NCT00947765|3131526|Superiority or Other|||||||0.0022|||||||Wilcoxon (Mann-Whitney)||||
1702830|NCT00947765|3131527|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1702831|NCT00947765|3131528|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1702832|NCT00947661|3131531|Non-Inferiority or Equivalence|Analysis of covariance included treatment, site, and intraocular pressure group as a covariate. Two-sided 95% confidence interval for the difference between treatment groups in estimated mean change from baseline lease square means was computed for each time point. Non-inferiority of SPARC drug relative to Reference was established if: 95% confidence interval included 0, the upper limit of the 95% CI was <1.5, and upper limit of 95% CI was <1 at most (at least 7 of 12) time point.|||||<|0.01|||||||ANCOVA||||
1702833|NCT00947531|3131556|Superiority or Other||Mean Difference (Final Values)|-6.17|||<|0.0001||95.0|-8.22|-4.13||P-value obtained from the F-test statistic of Cerebrolysin versus Placebo as part of ANCOVA (analysis of covariance). No adjustment for multiple comparisons was needed. The overall significance level alpha was fixed at alpha = 0.05 (two-sided).|ANCOVA|The study was designed to show significant differences in each of the two primary variables. No adjustment for multiple comparisons was needed.||The null-hypothesis stated no difference between the two treatment groups. A sample size of 103 evaluable patients per treatment group was estimated to allow for the detection of a significant group difference of 4.1 points in ADAS-cog+ weak 24 change score (standard deviation [SD] 9.0) in favor of Cerebrolysin with a power of 90% and a probability level of alpha-level 0.025 (one-sided).|
1702834|NCT00947518|3131557|Superiority||||||<|0.05|||||||Chi-squared||||For comparison of categorical variables among the three groups, Chi2 test followed by Bonferroni’s correction was used.
1702835|NCT00947518|3131558|Superiority or Other|||||||0.06|||||||Chi-squared||||
1702836|NCT00947518|3131559|Superiority or Other|||||||0.46|||||||ANOVA||||
1702837|NCT00947518|3131560|Superiority or Other|||||||0.99|||||||Kruskal-Wallis||||
1702838|NCT00947427|3131562|Superiority or Other (legacy)|||||||0.86|||||||ANCOVA||||
1702839|NCT00947310|3131596|Superiority or Other||Hazard Ratio (HR)|0.24|||<|0.001|2-Sided|95.0|0.15|0.4|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1|
1702840|NCT00947310|3131596|Superiority or Other||Hazard Ratio (HR)|0.21|||<|0.001|2-Sided|95.0|0.13|0.34|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1|
1702841|NCT00947310|3131597|Superiority or Other||Hazard Ratio (HR)|1.09||||0.8|2-Sided|95.0|0.58|2.05|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1|
1702842|NCT00947310|3131597|Superiority or Other||Hazard Ratio (HR)|1.32||||0.39|2-Sided|95.0|0.71|2.47|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm B. Null Hypothesis was that HR = 1|
1702843|NCT00947310|3131598|Superiority or Other||Hazard Ratio (HR)|0.56||||0.06|2-Sided|95.0|0.3|1.02|||Regression, Cox|||Hazard ratios (HR) were calculated to compare Arm A vs Arm C. Null Hypothesis was that HR = 1|
1702847|NCT00946998|3131637|Superiority||||||>|0.99||||||Hospitalization other than dialysis initiation|Chi-squared||||
1702852|NCT00946998|3131640|Superiority|||||||0.86||||||Represents remission outcome.|Mixed Models Analysis||||
1702853|NCT00946998|3131640|Superiority|||||||0.28||||||Represents the response outcome.|Mixed Models Analysis||||
1702854|NCT00946998|3131641|Superiority|||||||0.82|||||||Mixed Models Analysis||||
1702855|NCT00946920|3131647|Non-Inferiority or Equivalence|The non-inferiority limit for the difference between treatments (degarelix versus goserelin acetate) was chosen to be -5 percentage points.|Kaplan-Meier estimate|79.6|||||2-Sided|95.0|75.6|83.7||||||The cumulative probability of testosterone ≤0.5 ng/mL from Day 3 to Day 364 was estimated by the Kaplan-Meier method. Only testosterone measurements taken at scheduled trial visits from Day 3 to Day 364 were included in the analysis. The hypothesis to test was the following: a non-inferiority assessment determined whether degarelix was non-inferior to goserelin with respect to the cumulative probability of testosterone ≤0.5 ng/mL from Day 3 to Day 364.|
1702856|NCT00946712|3131658|Other|||||||0.06|||||||Cochran-Mantel-Haenszel|A stratified Cochran-Mantel-Haenszel test was conducted.|||
1702857|NCT00946712|3131659|Other|||||||0.48|||||||Cochran-Mantel-Haenszel|A stratified Cochran-Mantel-Haenszel test was conducted.|||
1702858|NCT00946712|3131663|Other||Hazard Ratio (HR)|0.92||||0.4|2-Sided|95.0|0.75|1.12|||Log Rank|A stratified log rank test was used.|||
1702859|NCT00946712|3131664|Other||Hazard Ratio (HR)|0.93||||0.22|2-Sided|95.0|0.83|1.04|||Log Rank|A stratified log rank test was used.|||
1702860|NCT00946322|3131670|Superiority or Other|||||||0.177|||||||t-test, 2 sided|||Paired sample t-test|
1702861|NCT00946322|3131671|Superiority or Other|||||||0.027|||||||t-test, 2 sided|||Paired sample t-test|
1702862|NCT00946322|3131672|Superiority or Other|||||||0.001|||||||t-test, 2 sided|||Paired sample t-test|
1702863|NCT00946322|3131673|Superiority or Other|||||||0.009|||||||t-test, 2 sided|||Paired sample t-test|
1702864|NCT00946322|3131674|Superiority or Other|||||||0.482|||||||t-test, 2 sided|||Paired sample t-test|
1702865|NCT00946322|3131675|Superiority or Other|||||||0.043|||||||t-test, 2 sided|||Paired sample t-test|
1702866|NCT00946322|3131676|Superiority or Other|||||||0.022|||||||t-test, 2 sided|||Paired sample t-tests were used. Due to variable skewness, variables were logarithm-transformed to improve their distributions.|
1702867|NCT00946322|3131677|Superiority or Other|||||||0.028|||||||t-test, 2 sided|||Paired sample t-test|
1702868|NCT00946192|3131686|Other|||||||0.018|||||||Mixed Models Analysis||||
1702869|NCT00946192|3131687|Other|Least square means||||||0.039|||||||Mixed Models Analysis||||
1702870|NCT00946101|3131701|Superiority or Other||rate difference|16.7|||||2-Sided|95.0|5.9|25.2||||||The number of subjects who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).|
1702871|NCT00946101|3131702|Superiority or Other||rate difference|7.2|||||2-Sided|95.0|-5.8|15.1||||||The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).|
1702872|NCT00946101|3131703|Superiority or Other||rate difference|7.0|||||2-Sided|95.0|-6.1|14.7||||||The number of subjects who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).|
1702873|NCT00946101|3131712|Superiority or Other||rate difference|-6.4|||||2-Sided|95.0|-20.3|7.1||||||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|
1702874|NCT00946101|3131715|Superiority or Other||rate difference|-6.3|||||2-Sided|95.0|-19.7|6.1||||||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|
1702875|NCT00946101|3131718|Superiority or Other||rate difference|13.3|||||2-Sided|95.0|-0.4|25.7||||||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|
1702876|NCT00946101|3131721|Superiority or Other||rate difference|5.1|||||2-Sided|95.0|-8.4|17.6||||||Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compated following each dose. Exact two-sided 95% confidence intervals (Chan and Zhang, 1999) on the rate difference (Vaccine minus Placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|
1702877|NCT00946101|3131722|Superiority or Other||rate difference|17.5|||||2-Sided|95.0|5.5|27.1||||||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).|
1702878|NCT00946101|3131723|Superiority or Other||rate difference|4.9|||||2-Sided|95.0|-9.6|13.8||||||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).|
1702879|NCT00946101|3131724|Superiority or Other||rate difference|1.5|||||2-Sided|95.0|-12.8|9.8||||||The number of subjects who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo).|
1702901|NCT00945659|3131804|Superiority||Mean Difference (Net)|-0.77|Standard Deviation|3.26||0.81|2-Sided|95.0|-7.15|5.62|||Generalized Estimating Equestion||||
1702902|NCT00945659|3131805|Superiority||Mean Difference (Net)|-2.21|Standard Deviation|2.95||0.45|2-Sided|95.0|-8.01|3.57|||Generalized Estimating Equation||||
1702903|NCT00945659|3131805|Superiority||Mean Difference (Net)|0.31|Standard Deviation|3.37||0.93|2-Sided|95.0|-6.33|6.91|||Generalized Estimating Equation||||
1702880|NCT00946101|3131725|Non-Inferiority or Equivalence|For the calculation of the power to rule out a 10% increase of fever rate in vaccine recipients with 300 evaluable subjects (240 vaccine and 60 placebo recipients), it is assumed that the true fever rate in the monovalent vaccine group is 3.0% to 8.0%,and the true fever rate in placebo group is 0% to 3% lower than the fever rate in the vaccine group.|rate difference|0.0|||||2-Sided|95.0|-6.4|3.1||||||The rate of subjects with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the pre-specified equivalence criterion of 10% which corresponds to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference < 10%|
1702881|NCT00945945|3131759|Superiority or Other||Least Squares Mean Difference|0.34||||0.105|2-Sided|95.0|-0.07|0.75||P-value for Change from Baseline to Endpoint (BOCF).|ANCOVA|Main Effect Model: Change = Treatment + Pooled Investigator + Baseline (Type III sums of squares).|Least Squares Mean Difference = DLX30-PLA minus PLA-DLX60.||
1702882|NCT00945893|3131769|Superiority or Other||rate difference|2.4|||||2-Sided|95.0|-9.3|10.8||||||The number of participants who achieved a post Dose 2 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).|
1702883|NCT00945893|3131770|Superiority or Other||rate difference|-6.0|||||2-Sided|95.0|-23.5|5.3||||||The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).|
1702884|NCT00945893|3131771|Superiority or Other||rate difference|5.8|||||2-Sided|95.0|-7.7|13.8||||||The number of participants who achieved a post Dose 1 HAI titer greater than or equal to 32 against the H1N1 strain was compared based on the upper limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).|
1702885|NCT00945893|3131780|Non-Inferiority or Equivalence|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|2.0|||||2-Sided|95.0|-12.6|14.9|||||||
1702886|NCT00945893|3131783|Non-Inferiority or Equivalence|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|-0.5|||||2-Sided|95.0|-14.7|11.8|||||||
1702887|NCT00945893|3131786|Non-Inferiority or Equivalence|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|0.4|||||2-Sided|95.0|-13.9|14.5|||||||
1702888|NCT00945893|3131789|Non-Inferiority or Equivalence|Rates of solicited symptoms following each dose (Days 1 to 8 and Days 1 to 15) between the two treatment groups were compared following each dose. Exact two-sided 95% CIs (Chan and Zhang, 1999) on the rate difference (monovalent vaccine minus placebo) were constructed. There were no prespecified equivalence criteria for the secondary analyses.|Rate difference|10.0|||||2-Sided|95.0|-4.1|22.8|||||||
1702889|NCT00945893|3131790|Superiority or Other||rate difference|9.3|||||2-Sided|95.0|-0.8|16.3||||||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).|
1702890|NCT00945893|3131791|Superiority or Other||rate difference|6.1|||||2-Sided|95.0|-5.6|12.6||||||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the two-sided 95% exact CIs for the rate difference (Vaccine minus Placebo).|
1702891|NCT00945893|3131792|Superiority or Other||rate difference|2.5|||||2-Sided|95.0|-8.8|7.7||||||The number of participants who experienced a post-dose seroresponse was compared based on the upper limit of the limit of the two-sided 95% exact CI for the rate difference (Vaccine minus Placebo).|
1702892|NCT00945893|3131793|Non-Inferiority or Equivalence|The currently proposed study provided at least 99.9% power to rule out a rate increase of 10 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 3%. Power is also high if the true difference is slightly greater than zero and the true fever rate is ≤ 3%.|Rate difference|0.0|||||2-Sided|95.0|-6.0|1.9||||||The upper limit of the two-sided 95% CI was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): Rate Difference ≥ 10%, HA (alternative): Rate Difference < 10%|
1702893|NCT00945854|3131796|Superiority or Other||||||<|0.05|||||||ANCOVA||||
1702894|NCT00945750|3131799|Superiority or Other||Geometric Mean Ratio|1.12||||||90.0|1.02|1.24|||||||
1702895|NCT00945750|3131800|Superiority or Other||Geometric Mean Ratio|1.11||||||90.0|1.04|1.2|||||||
1702896|NCT00945750|3131801|Non-Inferiority or Equivalence|If the 90% CI for the Cmax geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.|Geometric Mean Ratio|1.03||||||90.0|0.93|1.14|||||||
1702897|NCT00945750|3131802|Non-Inferiority or Equivalence|If the 90% CI for the AUC geometric mean ratio (famotidine CT without water/famotidine FCT with water) is within the hypothesized interval (0.80 and 1.25), then the primary hypothesis of bioequivalence between CT without water and FCT with water is accepted.|Geometric Mean Ratio|1.01||||||90.0|0.94|1.09|||||||
1702898|NCT00945659|3131803|Superiority||Mean Difference (Net)|-1.16|Standard Deviation|2.85||0.68|2-Sided|95.0|-6.74|4.43|||Generalized Estimating Equation||||
1702899|NCT00945659|3131803|Superiority||Mean Difference (Net)|0.99|Standard Deviation|2.6||0.71|2-Sided|95.0|-4.11|6.08|||Generalized Estimating Equation||||
1702900|NCT00945659|3131804|Superiority||Mean Difference (Net)|0.99|Standard Deviation|2.63||0.72|2-Sided|95.0|-4.11|6.08|||Generalized Estimating Equation||||
1703078|NCT00943150|3132352|Superiority or Other|||||||0.67|||||||ANOVA|||CD68+ at 0 weeks|
1702904|NCT00945659|3131806|Superiority||Mean Difference (Net)|-3.01|Standard Deviation|2.54||0.24|2-Sided|95.0|-7.99|1.96|||Generalized Estimating Equation||||
1702905|NCT00945659|3131806|Superiority||Mean Difference (Net)|1.95|Standard Deviation|2.66||0.46|2-Sided|95.0|-3.26|7.15|||Generalized Estimating Equation||||
1702906|NCT00945659|3131807|Superiority||Mean Difference (Net)|-0.93|Standard Deviation|1.14||0.41|2-Sided|95.0|-3.17|1.3|||Generalized Estimating Equation||||
1702907|NCT00945659|3131807|Superiority||Mean Difference (Net)|0.72|Standard Deviation|1.31||0.58|2-Sided|95.0|-1.86|3.29|||Generalized Estimating Equation||||
1702908|NCT00945659|3131808|Superiority||Mean Difference (Net)|-0.39|Standard Deviation|1.38||0.78|2-Sided|95.0|-3.09|2.32|||Generalized Estimating Equation||||
1702909|NCT00945659|3131808|Superiority||Mean Difference (Net)|0.39|Standard Deviation|1.23||0.75|2-Sided|95.0|-2.02|2.79|||Generalized Estimating Equation||||
1702910|NCT00945659|3131809|Superiority||Mean Difference (Net)|-3.71|Standard Deviation|1.36||0.007|2-Sided|95.0|-6.38|-1.04|||Generalized Estimating Equation||||
1702911|NCT00945659|3131809|Superiority||Mean Difference (Net)|1.32|Standard Deviation|1.66||0.43|2-Sided|95.0|-1.94|4.56|||Generalized Estimating Equation||||
1702912|NCT00945659|3131810|Superiority||Mean Difference (Net)|-2.59|Standard Deviation|1.87||0.08|2-Sided|95.0|-5.5|0.32|||Generalized Estimating Equation||||
1702913|NCT00945659|3131810|Superiority||Mean Difference (Net)|1.17|Standard Deviation|1.47||0.43|2-Sided|95.0|-1.7|4.04|||Generalized Estimating Equation||||
1702914|NCT00945659|3131811|Superiority||Mean Difference (Net)|-1.22|Standard Deviation|13.81||0.93|2-Sided|95.0|-28.26|25.83|||Generalized Estimating Equation||||
1702915|NCT00945659|3131811|Superiority||Mean Difference (Net)|0.71|Standard Deviation|63.4||0.99|2-Sided|95.0|-123.56|124.97|||Generalized Estimating Equation||||
1702916|NCT00945659|3131812|Superiority||Mean Difference (Net)|-0.41|Standard Deviation|0.92||0.65|2-Sided|95.0|-2.22|1.39|||Generalized Estimating Equation||||
1702917|NCT00945659|3131812|Superiority||Mean Difference (Net)|0.4|Standard Deviation|0.86||0.64|2-Sided|95.0|-1.29|2.08|||Generalized Estimating Equation||||
1702918|NCT00945659|3131813|Superiority||Mean Difference (Net)|2.53|Standard Deviation|5.76||0.66|2-Sided|95.0|||||Generalized Estimating Equation||||
1702919|NCT00945659|3131813|Superiority||Generalized Estimating Equation|-3.45|Standard Deviation|4.98||0.49|2-Sided|95.0|-13.21|6.32|||Generalized Estimating Equation||||
1702920|NCT00945659|3131814|Superiority||Mean Difference (Net)|-0.82|Standard Deviation|5.47||0.88|2-Sided|95.0|-11.54|9.9|||Generalized Estimating Equation||||
1702921|NCT00945659|3131814|Superiority||Mean Difference (Net)|-10.05|Standard Deviation|4.72||0.03|2-Sided|95.0|-19.3|-0.81|||Generalized Estimating Equation||||
1702922|NCT00945659|3131815|Superiority||Mean Difference (Net)|-0.41|Standard Error of the Mean|0.19||0.03|2-Sided|95.0|-0.78|-0.04|||Generalized Estimating Equation||||
1702923|NCT00945659|3131815|Superiority||Mean Difference (Net)|-0.003|Standard Deviation|0.2||0.86|2-Sided|95.0|-0.43|0.36|||Generalized Estimating Equation||||
1702924|NCT00945321|3131831|Superiority or Other||Least-Squares Mean Ratio|1.4|||||2-Sided|90.0|1.16|1.68||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects|
1702925|NCT00945321|3131831|Superiority or Other||Least-Squares Mean Ratio|1.14|||||2-Sided|90.0|0.96|1.34||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects|
1702926|NCT00945321|3131831|Superiority or Other||Least-Squares Mean Ratio|1.04|||||2-Sided|95.0|0.86|1.25||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects|
1702927|NCT00945321|3131831|Superiority or Other||Least-Squares Mean Ratio|1.33|||||2-Sided|90.0|1.13|1.56||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects|
1702928|NCT00945321|3131832|Superiority or Other||Least-Squares Mean Ratio|1.43|||||2-Sided|90.0|1.16|1.75||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects|
1702929|NCT00945321|3131832|Superiority or Other||Least-Squares Mean Ratio|1.22|||||2-Sided|90.0|1.01|1.46||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects|
1702930|NCT00945321|3131832|Superiority or Other||Least-Squares Mean Ratio|1.08|||||2-Sided|90.0|0.88|1.32||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects|
1702931|NCT00945321|3131832|Superiority or Other||Least-Squares Mean Ratio|1.47|||||2-Sided|90.0|1.23|1.76||||||The effect of a standard high-fat breakfast and a standard light breakfast on aprepitant plasma pharmacokinetics (AUC0-∞ and Cmax) following a single 165 mg oral dose of aprepitant and following a single 185 mg oral dose of aprepitant will be estimated in healthy young adult subjects|
1702932|NCT00945321|3131832|Non-Inferiority or Equivalence|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|1.05|||<|0.001|2-Sided|95.0|0.96|1.15||Hochberg’s step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels|two one-sided tests|The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR>0.80 and GMR≥1.25 vs. GMR<1.25).|||
1702933|NCT00945321|3131832|Non-Inferiority or Equivalence|Equivalence Bounds of (0.80, 1.25).|Least-Squares Mean Ratio|0.93|||<|0.001|2-Sided|95.0|0.84|1.02||Hochberg’s step-up procedure was applied to preserve the overall alpha level for the primary hypothesis that involved comparison at two oral dose levels.|two one-sided tests|The P-value obtained was the maximum of two P-values from two one-sided tests (GMR (Oral/IV) ≤0.80 vs. GMR>0.80 and GMR≥1.25 vs. GMR<1.25).|||
1702934|NCT00945282|3131850|Superiority or Other|||||||0.6922||||||The p-value is the value for placebo, at Day 1 to Day 8|Mixed Models Analysis|||Placebo, Day 1 to Day 8|
1702935|NCT00945282|3131850|Superiority or Other||||||<|0.0001||||||The p-value is the value for GSK2248761 30 mg, at Day 1 to Day 8|Mixed Models Analysis|||Day 1 to Day 8|
1702936|NCT00945282|3131851|Superiority||Mean Difference (Final Values)|-0.413||||0.221|2-Sided|95.0|-1.173|0.347|||ANCOVA||||
1702937|NCT00945282|3131852|Superiority||Mean Difference (Final Values)|-0.932||||0.042|2-Sided|95.0|-1.812|-0.053|||ANCOVA||||
1702938|NCT00945100|3131884|Superiority or Other|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.|
1702939|NCT00945100|3131887|Superiority or Other|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||An Exact Wilcoxon rank sum test was used for the difference between treatment groups in the distribution of levels of change in Randot Preschool Stereoacuity from randomization to 10 weeks.|
1702940|NCT00945100|3131891|Superiority or Other|||||||0.12|||||||Fisher Exact|||Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the final exam.|
1702941|NCT00945100|3131893|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Fisher's exact test was used to compare the proportion of participants in each treatment group with a loss of 2 or more lines in the better of the initial test and retest (if indicated) fellow eye visual acuities at the 10-week exam.|
1702942|NCT00945100|3131901|Superiority or Other||Mean Difference (Net)|0.5|||||2-Sided|95.0|0.04|1.0|||||||
1702943|NCT00945100|3131903|Superiority or Other|||||||0.5|||||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within cause of amblyopia was assessed by including an interaction term between treatment group and amblyopia cause in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.|
1702944|NCT00945100|3131903|Superiority or Other|||||||0.37|||||||ANCOVA|||The treatment effect within amblyopic eye visual acuity at randomization was assessed by including an interaction term between treatment group and visual acuity in the ANCOVA model, adjusting for the main effects corresponding to the interaction term.|
1702945|NCT00945100|3131903|Superiority or Other|||||||0.49|||||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within age at randomization was assessed by including an interaction term between treatment group and age in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.|
1702946|NCT00945100|3131903|Superiority or Other|||||||0.89|||||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within race/ethnicity was assessed by including an interaction term between treatment group and race/ethnicity in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.|
1702947|NCT00945100|3131903|Superiority or Other|||||||0.04|||||||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The treatment effect within gender was assessed by including an interaction term between treatment group and gender in the ANCOVA model, adjusting for amblyopic eye visual acuity at randomization and main effects corresponding to the interaction term.|
1702948|NCT00945100|3131907|Superiority or Other||Mean Difference (Net)|0.6||||0.002|2-Sided|95.0|0.3|1.0|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.||The primary analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis was a 2-sided test for efficacy to test the null hypothesis of no treatment difference, assuming 90% power and a type I error rate of 5%.|
1702949|NCT00945100|3131909|Superiority or Other||Mean Difference (Net)|0.5||||0.01|2-Sided|95.0|0.1|1.0|||ANCOVA|The ANCOVA model included interocular difference at randomization as an adjustment covariate.|||
1702950|NCT00945100|3131910|Superiority or Other||Risk difference (unadjusted)|22.0||||0.003|2-Sided|95.0|8.0|35.0|||Regression, Logistic|The logistic regression model included amblyopic eye visual acuity at randomization as an adjustment covariate.|||
1702951|NCT00945035|3131914|Non-Inferiority or Equivalence|Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio [GMR] no less than 0.8 and no greater than 1.25).|Least-Squares Mean Ratio|1.03||||||90.0|0.95|1.11||||||Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction|
1702952|NCT00945035|3131915|Non-Inferiority or Equivalence|Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio [GMR] no less than 0.8 and no greater than 1.25).|Least-Squares Mean Ratio|1.02||||||90.0|0.97|1.07||||||Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction|
1702953|NCT00944710|3131923|Superiority or Other|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||The distribution of 12-week Randot Preschool Stereoacuity scores was compared between treatment groups using a Wilcoxon rank sum test.|
1702954|NCT00944710|3131924|Superiority or Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||The distribution of 12-week Randot Preschool Stereoacuity scores was compared between treatment groups using a Wilcoxon rank sum test.|
1703079|NCT00943150|3132352|Superiority or Other|||||||0.71|||||||ANOVA|||CD3+ at 6 weeks|
1702955|NCT00944710|3131933|Superiority or Other||Mean Difference (Net)|0.1||||0.55|2-Sided|95.0|-0.23|0.43|||ANCOVA|||A treatment group difference in fellow-eye visual acuity change at the 12-week exam was evaluated using an ANCOVA model, adjusting for the fellow-eye visual acuity at randomization.|
1702956|NCT00944710|3131941|Superiority or Other||Mean Difference (Net)|0.05||||0.12|2-Sided|95.0|-0.01|0.12|||ANCOVA|The ANCOVA model included amblyopic eye visual acuity at randomization as an adjustment covariate.|Positive values favor the Intensified Treatment group|The primary analysis was a treatment group comparison of the masked 10-week amblyopic eye visual acuity using an analysis of covariance (ANCOVA) model, adjusting for visual acuity at randomization. The analysis was a 2-sided test for efficacy to test the null hypothesis of no treatment difference, assuming 90% power and a type I error rate of 5%.|
1702957|NCT00944710|3131946|Superiority or Other||Risk Difference (RD)|1.0||||0.33|2-Sided|95.0|-10.0|30.0|||Binomial regression|adjusted for visual acuity at randomization|||
1702958|NCT00944671|3131950|Superiority or Other||Geometric Mean Ratio|1.03||||||90.0|0.93|1.14|||||||
1702959|NCT00944671|3131951|Superiority or Other||Geometric Mean Ratio|1.05||||||90.0|0.98|1.13|||||||
1702960|NCT00944671|3131952|Non-Inferiority or Equivalence|Assuming a true within subject variance for natural log Cmax of 0.017, there is a 0.999 probability that the 90% confidence interval for the true geometric mean ratio of Cmax for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.|Geometric Mean Ratio|1.03||||||90.0|0.93|1.13|||||||
1702961|NCT00944671|3131953|Non-Inferiority or Equivalence|Given a 3-period crossover design, assuming a true within subject variance for natural log AUC of 0.029, 24 subjects completing the study, and alpha = 0.05, there is a 0.995 probability that the 90% confidence interval for the true geometric mean ratio of AUC for (famotidine antacid combination EZ Chew tablet without water/ famotidine antacid combination tablet with water) will be contained in (0.80, 1.25), given that the true ratio is one.|Geometric Mean Ratio|1.05||||||90.0|0.98|1.13|||||||
1702962|NCT00944658|3131955|Superiority|||||||0.108|||||||ANCOVA|Rank Ancova|||
1702963|NCT00944658|3131956|Superiority|||||||0.58|||||||ANCOVA||||
1702964|NCT00944658|3131957|Superiority|||||||0.139|||||||ANCOVA||||
1702965|NCT00944645|3131958|Non-Inferiority or Equivalence|Primary research hypothesis IV: The Cmax of laropiprant following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of MK0524 Cmax is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|1.02||||||95.0|0.96|1.09||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"|
1702966|NCT00944645|3131959|Non-Inferiority or Equivalence|Primary research hypothesis III: The AUC0-infinity of laropiprant following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of MK0524 AUC0-∞ is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|1.0||||||95.0|0.95|1.05||||||"Group B: MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~Group A: MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"|
1702967|NCT00944645|3131960|Non-Inferiority or Equivalence|Primary research hypothesis II: The total urinary excretion of niacin and niacin metabolites following the administration of MK0524 (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of total urinary excretion of niacin and its metabolites is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|0.94||||||90.0|0.89|0.98||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"|
1702968|NCT00944645|3131961|Non-Inferiority or Equivalence|Primary research hypothesis I: The Cmax of nicotinuric acid (NUA) following the administration of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) tablets from 2 manufacturing sites is similar (i.e., the true GMR of NUA Cmax is contained within the bioequivalence interval (0.80, 1.25)).|Geometric Mean Ratio|0.98||||||90.0|0.93|1.03||||||"MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) tablet from new manufacturing site (Source 2)~MK0524A (1000 mg ER Niacin/20 mg MK-laropiprant) Phase III tablet (Source 1)"|
1702969|NCT00944450|3131968|Non-Inferiority or Equivalence|Pre-specified equivalence bounds = (0.80, 1.25) for Cmax geometric mean ratio (B/A)|Geometric Mean Ratio|1.07||||||90.0|0.94|1.22||||||100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)|
1702970|NCT00944450|3131969|Non-Inferiority or Equivalence|Pre-specified equivalence bounds = (0.80, 1.25) for AUC geometric mean ratio (B/A)|Geometric Mean Ratio|1.05||||||90.0|1.02|1.07||||||100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)|
1702971|NCT00943852|3132069|Superiority or Other||||||<|0.001||||||1-sided, alpha = 0.05|ANOVA|Fixed effects model with terms for subject, treatment and period|||
1702972|NCT00943852|3132070|Superiority or Other||||||<|0.001||||||1-sided, alpha = 0.05|ANOVA|Fixed effects model with terms for subject, treatment and period|||
1702973|NCT00943826|3132075|Superiority or Other||Hazard Ratio (HR)|0.61|||<|0.0001|2-Sided|95.0|0.53|0.71||Stratified by Region and RPA Class.|Log Rank||Stratified by Region and RPA Class.||
1702974|NCT00943826|3132076|Superiority or Other||Hazard Ratio (HR)|0.88||||0.0987|2-Sided|95.0|0.76|1.02|||Log Rank|Stratified by Region and RPA Class|Stratified by Region and RPA Class.||
1702975|NCT00943826|3132077|Superiority or Other||Hazard Ratio (HR)|0.64|||<|0.0001|2-Sided|95.0|0.55|0.74||Stratified by Region and Recursive partitioning analysis (RPA) Class|Log Rank||Stratified by Region and RPA Class.||
1702976|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.4|||||2-Sided|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58|
1702977|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.4|||||2-Sided|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58|
1702978|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.0|||||2-Sided|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 58|
1702979|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.4|||||2-Sided|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52|
1702980|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.3|||||2-Sided|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52|
1702981|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.0|||||2-Sided|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 52|
1702982|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.4|||||2-Sided|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45|
1702983|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.2|||||2-Sided|95.0|-0.7|1.1|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45|
1702984|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|-0.2|||||2-Sided|95.0|-1.1|0.5|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 45|
1702985|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.4|||||2-Sided|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33|
1702986|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.4|||||2-Sided|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33|
1702987|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.0|||||2-Sided|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 33|
1702988|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.2|||||2-Sided|95.0|-0.5|1.0|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31|
1702989|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.2|||||2-Sided|95.0|-0.6|1.0|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31|
1702990|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.0|||||2-Sided|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 31|
1702991|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.4|||||2-Sided|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18|
1702992|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.2|||||2-Sided|95.0|-0.7|1.1|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18|
1702993|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|-0.2|||||2-Sided|95.0|-1.1|0.5|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 18|
1702994|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.4|||||2-Sided|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16|
1702995|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.4|||||2-Sided|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16|
1702996|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.0|||||2-Sided|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 16|
1703080|NCT00943150|3132352|Superiority or Other|||||||0.02|||||||ANOVA|||CD3+ at 3 weeks|
1702997|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.4|||||2-Sided|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11|
1702998|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.4|||||2-Sided|95.0|-0.4|1.3|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11|
1702999|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.0|||||2-Sided|95.0|-0.7|0.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 11|
1703000|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.6|||||2-Sided|95.0|-0.4|1.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6|
1703001|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.5|||||2-Sided|95.0|-0.4|1.7|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6|
1703002|NCT00943722|3132114|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5)|Percentage Point Difference|0.0|||||2-Sided|95.0|-0.9|0.9|||||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 6|
1703003|NCT00943722|3132115|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.0|||<|0.001|2-Sided|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58|
1703004|NCT00943722|3132115|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.3|||<|0.001|2-Sided|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52|
1703005|NCT00943722|3132115|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.5|||<|0.001|2-Sided|95.0|-0.1|2.0|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45|
1703006|NCT00943722|3132115|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.3|||<|0.001|2-Sided|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33|
1703007|NCT00943722|3132115|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.3|||<|0.001|2-Sided|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31|
1703008|NCT00943722|3132115|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.3|||<|0.001|2-Sided|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18|
1703009|NCT00943722|3132115|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.0|||<|0.001|2-Sided|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16|
1703010|NCT00943722|3132115|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.0|||<|0.001|2-Sided|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11|
1703011|NCT00943722|3132115|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.1|||<|0.001|2-Sided|95.0|-0.7|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Males (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6|
1703012|NCT00943722|3132116|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.0|||<|0.001|2-Sided|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58|
1703013|NCT00943722|3132116|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.3|||<|0.001|2-Sided|95.0|-0.4|1.7|||Miettinen and Nurminen||9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52|
1703014|NCT00943722|3132116|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.4|||<|0.001|2-Sided|95.0|-0.6|1.8|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45|
1703015|NCT00943722|3132116|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.3|||<|0.001|2-Sided|95.0|-0.4|1.6|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33|
1703081|NCT00943150|3132352|Superiority or Other|||||||0.33|||||||ANOVA|||CD3+ at 0 weeks|
1703016|NCT00943722|3132116|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.3|||<|0.001|2-Sided|95.0|-0.4|1.7|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31|
1703017|NCT00943722|3132116|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.1|||<|0.001|2-Sided|95.0|-0.8|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18|
1703018|NCT00943722|3132116|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.0|||<|0.001|2-Sided|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16|
1703019|NCT00943722|3132116|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.0|||<|0.001|2-Sided|95.0|-0.7|1.2|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11|
1703020|NCT00943722|3132116|Non-Inferiority or Equivalence|Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5|Percentage Point Difference|0.1|||<|0.001|2-Sided|95.0|-0.8|1.5|||Miettinen and Nurminen||Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6|
1703021|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.12|||||2-Sided|95.0|1.0|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58|
1703022|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.07|||||2-Sided|95.0|0.96|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 58|
1703023|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.95|||||2-Sided|95.0|0.86|1.06|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 58|
1703024|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.03|||||2-Sided|95.0|0.92|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52|
1703025|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.95|||||2-Sided|95.0|0.85|1.07|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 52|
1703026|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.92|||||2-Sided|95.0|0.83|1.03|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 52|
1703027|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.24|||||2-Sided|95.0|1.08|1.42|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45|
1703028|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.04|||||2-Sided|95.0|0.91|1.18|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 45|
1703029|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.84|||||2-Sided|95.0|0.73|0.95|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 45|
1703030|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.01|||||2-Sided|95.0|0.9|1.12|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33|
1703031|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||2-Sided|95.0|0.94|1.17|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 33|
1703032|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||2-Sided|95.0|0.94|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 33|
1703033|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.02|||||2-Sided|95.0|0.9|1.15|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31|
1703034|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.02|||||2-Sided|95.0|0.91|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 31|
1703035|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||2-Sided|95.0|0.89|1.13|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 31|
1703082|NCT00943150|3132353|Superiority or Other||||||<|0.001|||||||Regression, Linear||||
1703191|NCT00939029|3132913|Superiority or Other||Odds Ratio (OR)|2.2||||0.087|2-Sided|90.0|0.8|6.0||1 tailed|Regression, Logistic||||
1703036|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.11|||||2-Sided|95.0|0.97|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18|
1703037|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.11|||||2-Sided|95.0|0.98|1.26|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 18|
1703038|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||2-Sided|95.0|0.89|1.14|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 18|
1703039|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.05|||||2-Sided|95.0|0.94|1.17|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16|
1703040|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|1.0|||||2-Sided|95.0|0.9|1.12|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 16|
1703041|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|0.96|||||2-Sided|95.0|0.86|1.06|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 16|
1703042|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.07|||||2-Sided|95.0|0.95|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11|
1703043|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.07|||||2-Sided|95.0|0.95|1.2|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 11|
1703044|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.0|||||2-Sided|95.0|0.9|1.11|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 11|
1703045|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.06|||||2-Sided|95.0|0.95|1.19|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6|
1703046|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0).|GMT ratio|1.03|||||2-Sided|95.0|0.93|1.16|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 3)|Anti-HPV 6|
1703047|NCT00943722|3132120|Non-Inferiority or Equivalence|equivalence requires that the two-sided 95% CI for the ratio of the GMTs be entirely contained within the interval (0.5, 2.0)|GMT ratio|0.97|||||2-Sided|95.0|0.88|1.08|||||GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 9- to 15-Year-Old Females (Lot 2)|Anti-HPV 6|
1703048|NCT00943722|3132121|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.66|||<|0.001|2-Sided|95.0|2.37|2.98||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58|
1703049|NCT00943722|3132121|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.47|||<|0.001|2-Sided|95.0|2.19|2.79||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 52|
1703050|NCT00943722|3132121|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|3.33|||<|0.001|2-Sided|95.0|2.89|3.84||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45|
1703051|NCT00943722|3132121|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.57|||<|0.001|2-Sided|95.0|2.29|2.88||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33|
1703052|NCT00943722|3132121|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.95|||<|0.001|2-Sided|95.0|2.6|3.34||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31|
1703053|NCT00943722|3132121|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|3.2|||<|0.001|2-Sided|95.0|2.8|3.65||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18|
1703097|NCT00943072|3132395|Superiority or Other||Least Square Mean|-487.1|||||||||||||The Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.||
1705479|NCT00911508|3136681|Superiority||Cox Proportional Hazard|0.86|||||2-Sided|95.0|0.65|1.15|||||||
1703054|NCT00943722|3132121|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.45|||<|0.001|2-Sided|95.0|2.19|2.74||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 16|
1703055|NCT00943722|3132121|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.1|||<|0.001|2-Sided|95.0|1.88|2.36||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11|
1703056|NCT00943722|3132121|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.31|||<|0.001|2-Sided|95.0|2.07|2.59||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old males (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6|
1703057|NCT00943722|3132122|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.18|||<|0.001|2-Sided|95.0|1.93|2.45||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 58|
1703058|NCT00943722|3132122|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.22|||<|0.001|2-Sided|95.0|1.97|2.51||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1|Anti-HPV 52|
1703059|NCT00943722|3132122|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.62|||<|0.001|2-Sided|95.0|2.27|3.03||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 45|
1703060|NCT00943722|3132122|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.1|||<|0.001|2-Sided|95.0|1.87|2.36||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 33|
1703061|NCT00943722|3132122|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.51|||<|0.001|2-Sided|95.0|2.21|2.85||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 31|
1703062|NCT00943722|3132122|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|2.44|||<|0.001|2-Sided|95.0|2.13|2.8||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 18|
1703063|NCT00943722|3132122|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|1.98|||<|0.001|2-Sided|95.0|1.77|2.22||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1|Anti-HPV 16|
1703064|NCT00943722|3132122|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% CI of GMT ratio be greater than 0.67|GMT ratio|1.83|||<|0.001|2-Sided|95.0|1.63|2.06||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 11|
1703065|NCT00943722|3132122|Non-Inferiority or Equivalence|non-inferiority requires that the lower bound of two-sided 95% confidence interval (CI) of GMT ratio be greater than 0.67|GMT ratio|1.9|||<|0.001|2-Sided|95.0|1.7|2.14||one-sided tests of non-inferiority conducted at the alpha=0.025 level|ANOVA|model with a response of log individual titers and a fixed effect for comparison group|GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 16- to 26-Year-Old Females (Lot 1)|Anti-HPV 6|
1703066|NCT00943579|3132188|Superiority or Other||||||>|0.05|||||||Chi-squared|||Chi-square analyses were used to assess CGI-I scores. there were no transformations.|
1703067|NCT00943319|3132234|Other||Median Disease Free Survival Time|172.0|||||2-Sided|95.0|85.0|436.0||||||Estimated median survival time|
1703068|NCT00943319|3132235|Other||Median Survival time|161.0|||||2-Sided|95.0|121.0|305.0|||||||
1703069|NCT00943150|3132346|Superiority or Other|||||||0.0412|||||||Exact Wilcoxon test||||
1703070|NCT00943150|3132347|Superiority or Other|||||||0.999|||||||Exact Wilcoxon test||||
1703071|NCT00943150|3132348|Superiority or Other|||||||0.4589|||||||Exact Wilcoxon test||||
1703072|NCT00943150|3132349|Superiority or Other|||||||0.59|||||||Exact Wilcoxon test|||Postoperative narcotic use comparison|
1703073|NCT00943150|3132349|Superiority or Other|||||||0.076|||||||Exact Wilcoxon test|||Intraoperative narcotic use comparison|
1703074|NCT00943150|3132350|Superiority or Other|||||||0.0898|||||||Exact Wilcoxon test||||
1703075|NCT00943150|3132351|Superiority or Other|||||||0.1128|||||||Exact Wilcoxon rank-sum test||||
1703076|NCT00943150|3132352|Superiority or Other|||||||0.48|||||||ANOVA|||CD68+ at 6 weeks|
1703077|NCT00943150|3132352|Superiority or Other|||||||0.01|||||||ANOVA|||CD68+ at 3 weeks|
1703083|NCT00943124|3132354|Non-Inferiority or Equivalence|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.92||||||90.0|0.89|0.94||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)|
1703084|NCT00943124|3132355|Non-Inferiority or Equivalence|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.77||||||90.0|0.72|0.82||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)|
1703085|NCT00943124|3132356|Non-Inferiority or Equivalence|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.08||||||90.0|1.02|1.14||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)|
1703086|NCT00943124|3132357|Non-Inferiority or Equivalence|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.02||||||90.0|0.99|1.04||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)|
1703087|NCT00943124|3132358|Non-Inferiority or Equivalence|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.92||||||90.0|0.87|0.97||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)|
1703088|NCT00943124|3132359|Non-Inferiority or Equivalence|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|0.97||||||90.0|0.93|1.0||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)|
1703089|NCT00943124|3132360|Non-Inferiority or Equivalence|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.11||||||90.0|1.05|1.16||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)|
1703090|NCT00943124|3132361|Non-Inferiority or Equivalence|Power: If the true geometric mean ratio (GMR MK0524B/Simvastatin + MK0524A) is 1.00 for all the eight primary endpoints, then a sample size of N=220 subjects provides this study with greater than 99.2% probability of observing the 90% confidence intervals (CIs) of all the eight endpoints to be contained within [0.80, 1.25], assuming nonnegative associations among the 8 endpoints.|Least-Squares Mean Ratio|1.14||||||90.0|1.09|1.2||||||Least-Squares Mean Ratio (Fixed Dose Combination (FDC)/Co-administration)|
1703091|NCT00943111|3132378|Non-Inferiority or Equivalence|The sample size for study was based on expected stability rates of 95% for the Imiglucerase group and 85% for the Eliglustat group, power of 85%, a one-sided significance level of 0.025, a non-inferiority margin of 25%, and a 20% non-evaluable/drop-out rate. Eliglustat was declared non-inferior to Imiglucerase if the lower-bound of the 95% confidence interval for the difference was within the non-inferiority margin of 25%.|Difference in Percentage Stable|-8.8|||||2-Sided|95.0|-17.6|4.2|||||||
1703092|NCT00943098|3132379|Non-Inferiority or Equivalence|The sample size calculation was based on a hypothesis of non-inferiority of Diclofenac HPBCD 75mg/ml s.c. versus Voltarol® 75mg/3ml i.m. with regard to the primary efficacy variable (PID at 1.5 hours after study drug administration). The clinically significant difference (delta) between groups was defined in 15 mm of pain intensity difference (a 30% decline from starting levels of pain intensity of 50 mm or greater on a 0 to 100 VAS).|Mean Difference (Final Values)|-0.51||||0.862|2-Sided|95.0|-6.23|5.22|||ANCOVA|||Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.|
1703093|NCT00943098|3132392|Non-Inferiority or Equivalence|The sample size calculation was based on a hypothesis of non-inferiority of Diclofenac HPBCD 75mg/ml s.c. versus Voltarol® 75mg/3ml i.m. with regard to the primary efficacy variable (PID at 1.5 hours after study drug administration). The clinically significant difference (delta) between groups was defined in 15 mm of pain intensity difference (a 30% decline from starting levels of pain intensity of 50 mm or greater on a 0 to 100 VAS).|Mean Difference (Final Values)|-0.71||||0.813|2-Sided|95.0|-6.62|5.2|||ANCOVA|||Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.|
1703094|NCT00943072|3132393|Superiority or Other||Least Square Mean|8.8|||||||||||||Least Square Mean indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.||
1703095|NCT00943072|3132393|Superiority or Other||Risk Difference (RD)|6.26||||0.0009|2-Sided|95.0|2.61|9.91|||ANCOVA||The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.||
1703096|NCT00943072|3132394|Superiority or Other||Risk Difference (RD)|-6.6||||0.0059|2-Sided|95.0|-12.2|-1.1|||Cochran-Mantel-Haenszel|CMH adjusted difference|The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.||
1706401|NCT00895531|3138579|Superiority|||||||0.95|||||||t-test, 2 sided||||
1703098|NCT00943072|3132395|Superiority or Other||Risk Difference (RD)|-311.9|||<|0.0001|2-Sided|95.0|-389.4|-234.4|||ANCOVA||The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group. 95% confidence interval is for the RD.||
1703099|NCT00943072|3132396|Superiority or Other||Least Square Mean|16.36|||||||||||||LS Mean indicates is the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.||
1703100|NCT00943072|3132396|Superiority or Other||Risk Difference (RD)|21.7|||<|0.0001|2-Sided|95.0|17.36|26.04|||ANCOVA||RD is the IAI group minus sham group. 95% confidence interval is for the RD.||
1703101|NCT00943072|3132397|Superiority or Other||Risk Difference (RD)|44.8|||<|0.0001|2-Sided|95.0|33.0|56.6||P-value for the primary endpoint was calculated using 2-sided Cochran-Mantel-Haenszel test adjusted by regions (North America vs. Rest of World) and baseline BCVA (BCVA > 20/200 and BCVA ≤ 20/200)|Cochran-Mantel-Haenszel|CMH adjusted difference|The Risk Difference (RD) indicates the difference between the IAI (EYLEA, VEGF Trap-Eye) Treatment group minus the Sham Treatment group.||
1703102|NCT00942890|3132425|Superiority or Other||||||<|0.05|||||||Regression, Linear||||
1703103|NCT00942890|3132431|Superiority or Other||Slope|0.9|Standard Error of the Mean|0.24|<|0.05|2-Sided||||||Mixed Models Analysis||||
1703104|NCT00942708|3132442|Other|Single group evaluation of change in PVR between 12 weeks and baseline (T-test for one group, 2-sided, p<0.05 considered significant)||||||0.09|||||||t-test, 1 sided||||
1703105|NCT00942604|3132443|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1703106|NCT00942604|3132444|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1703107|NCT00942448|3132456|Superiority or Other||Mean Difference (Final Values)|25.1|||<|0.001|2-Sided|95.0|18.4|31.7|||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."|
1703108|NCT00942448|3132456|Superiority or Other||Mean Difference (Final Values)|24.2|||<|0.001|2-Sided|95.0|17.6|30.8|||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."|
1703109|NCT00942448|3132469|Superiority or Other||Mean Difference (Final Values)|25.1||||0.001|2-Sided|95.0|18.4|31.7|||ANCOVA||||
1703110|NCT00942448|3132469|Superiority or Other||Mean Difference (Final Values)|24.2|||<|0.001|||||||ANCOVA|||"The sample size calculation was based on a hypothesis of superiority of diclofenac HPBCD s.c. 25mg/ml and 50 mg/ml compared to Placebo with regard to the primary efficacy variable (PID at 1.5 hours following drug administration).~A sample size of 60 in each group had 95% power to detect a difference between diclofenac HPBCD s.c. 25 mg/ml and placebo in means of 15 mm, assuming that the common standard deviation was 22.5 and using a two group t-test with a 0.05 two-sided significance level."|
1703111|NCT00942331|3132481|Superiority||Hazard Ratio (HR)|0.87||||0.1707|2-Sided|95.0|0.72|1.06|||Log Rank|Stratified log rank|||
1703112|NCT00942188|3132492|Superiority or Other (legacy)||LS Mean Difference|-0.221|||||2-Sided|95.0|-0.59|0.15|||||||
1703113|NCT00942188|3132492|Superiority or Other (legacy)||LS Mean Difference|-0.396|||||2-Sided|95.0|-0.79|0.0|||||||
1703114|NCT00942188|3132492|Superiority or Other (legacy)||LS Mean Difference|-0.267|||||2-Sided|95.0|-0.61|0.08|||||||
1703115|NCT00942188|3132492|Superiority or Other (legacy)||LS Mean Difference|-0.227|||||2-Sided|95.0|-0.59|0.13|||||||
1703116|NCT00942188|3132492|Superiority or Other (legacy)||LS Mean Difference|-0.369|||||2-Sided|95.0|-0.74|0.0|||||||
1703117|NCT00942188|3132492|Superiority or Other (legacy)||LS Mean Difference|-0.27|||||2-Sided|95.0|-0.59|0.05|||||||
1703118|NCT00942188|3132494|Superiority or Other (legacy)||LS Mean Difference|-1.635|||||2-Sided|95.0|-9.16|5.89|||||||
1703119|NCT00942188|3132494|Superiority or Other (legacy)||LS Mean Difference|-2.324|||||2-Sided|95.0|-10.21|5.56|||||||
1703120|NCT00942188|3132494|Superiority or Other (legacy)||LS Mean Difference|-2.995|||||2-Sided|95.0|-9.82|3.83|||||||
1703121|NCT00942188|3132495|Superiority or Other (legacy)||LS Mean Difference|-0.61|||||2-Sided|95.0|-1.76|0.54|||||||
1703122|NCT00942188|3132495|Superiority or Other (legacy)||LS Mean Difference|-1.252|||||2-Sided|95.0|-2.48|-0.03|||||||
1703123|NCT00942188|3132495|Superiority or Other (legacy)||LS Mean Difference|-0.854|||||2-Sided|95.0|-1.94|0.23|||||||
1703124|NCT00942175|3132497|Superiority or Other||||||<|0.0001||||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA||||
1703125|NCT00942175|3132497|Superiority or Other||||||<|0.001||||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA||||
1703126|NCT00942175|3132497|Superiority or Other||||||<|0.148||||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA||||
1703127|NCT00942175|3132497|Superiority or Other||||||<|0.004||||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA||||
1703128|NCT00942175|3132498|Superiority or Other||||||<|0.001||||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA||||
1703129|NCT00942175|3132498|Superiority or Other||||||<|0.001||||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA||||
1703130|NCT00942175|3132498|Superiority or Other||||||<|0.445||||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA||||
1703131|NCT00942175|3132498|Superiority or Other||||||<|0.035||||||From ANOVA models in which the least-square means between two regimens are compared.|ANOVA||||
1703132|NCT00942175|3132499|Superiority or Other||Mean Difference (Final Values)|11.4437|||||2-Sided|90.0|7.1791|15.7083|||||Included only participants with complete data for both regimens. Values are least squares mean difference.||
1703133|NCT00942175|3132499|Superiority or Other||Mean Difference (Final Values)|11.0407|||||2-Sided|90.0|6.5219|15.5595|||||Included only participants with complete data for both regimens. Values are least squares mean difference.||
1703134|NCT00942175|3132499|Superiority or Other||Mean Difference (Final Values)|2.0474|||||2-Sided|90.0|-0.8555|4.9503|||||Included only participants with complete data for both regimens. Values are least squares mean difference.||
1703135|NCT00942175|3132499|Superiority or Other||Mean Difference (Final Values)|4.1016|||||2-Sided|90.0|0.0348|8.1684|||||Included only participants with complete data for both regimens. Values are least squares mean difference.||
1703136|NCT00942175|3132500|Superiority or Other||Mean Difference (Final Values)|0.8389|||||2-Sided|90.0|0.644|1.0928|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.||
1703137|NCT00942175|3132500|Superiority or Other||Mean Difference (Final Values)|0.6943|||||2-Sided|90.0|0.6438|0.7487|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.||
1703138|NCT00942175|3132500|Superiority or Other||Mean Difference (Final Values)|0.9103|||||2-Sided|90.0|0.8567|0.9672|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.||
1703139|NCT00942175|3132500|Superiority or Other||Mean Difference (Final Values)|0.8573|||||2-Sided|90.0|0.802|0.9165|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.||
1703140|NCT00942175|3132501|Superiority or Other||Mean Difference (Final Values)|0.6783|||||2-Sided|90.0|0.5063|0.9087|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.||
1703141|NCT00942175|3132501|Superiority or Other||Mean Difference (Final Values)|0.5564|||||2-Sided|90.0|0.4877|0.6347|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.||
1703142|NCT00942175|3132501|Superiority or Other||Mean Difference (Final Values)|0.734|||||2-Sided|90.0|0.6516|0.8269|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.||
1703143|NCT00942175|3132501|Superiority or Other||Mean Difference (Final Values)|0.7|||||2-Sided|90.0|0.6106|0.8026|||||The mean difference refers to the point estimates of the relative bioavailability. With its confidence intervals, it was obtained from the ANOVA model on the natural logarithm transformed data.||
1703144|NCT00941668|3132595|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1703145|NCT00941668|3132596|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1703146|NCT00941603|3132608|Superiority or Other||Difference in percent|0.7||||0.68|2-Sided|95.0|-2.7|4.2|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|||
1703147|NCT00941603|3132608|Superiority or Other||Difference in percent|-1.4||||0.41|2-Sided|95.0|-4.9|2.0|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|||
1703148|NCT00941603|3132608|Superiority or Other||Difference in percent|-4.4||||0.01|2-Sided|95.0|-7.9|-1.0|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|||
1703149|NCT00941603|3132608|Superiority or Other||Difference in percent|-3.6||||0.04|2-Sided|95.0|-7.1|-0.2|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|||
1703150|NCT00941603|3132608|Superiority or Other||Difference in percent|-3.0||||0.09|2-Sided|95.0|-6.5|0.4|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|||
1703151|NCT00941603|3132609|Superiority or Other||Difference in percent|-0.4||||0.85|2-Sided|95.0|-4.0|3.3|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|||
1703152|NCT00941603|3132609|Superiority or Other||Difference in percent|-1.3||||0.48|2-Sided|95.0|-5.0|2.4|||ANOVA|LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|||
1703153|NCT00941603|3132609|Superiority or Other||Difference in percent|-5.7|||<|0.01|2-Sided|95.0|-9.4|-2.0|||ANOVA|||LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|
1703154|NCT00941603|3132609|Superiority or Other||Difference in percent|-3.1|||<|0.1|2-Sided|95.0|-6.7|0.6||LS means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|ANOVA||||
1703155|NCT00941603|3132609|Superiority or Other||Difference in percent|-3.5|||<|0.06|2-Sided|95.0|-7.2|0.2|||ANOVA|Least-square (LS) means and LS standard errors based on ANOVA model extracting effects due to treatment, gender, and primary diagnosis.|||
1703156|NCT00941304|3132622|Superiority or Other||LS Mean Difference|8.74||||0.0809|2-Sided|95.0|-1.11|18.56|||ANCOVA||||
1703157|NCT00941304|3132622|Superiority or Other||LS Mean Difference|6.26||||0.2183|2-Sided|95.0|-3.81|16.34|||ANCOVA||||
1703158|NCT00941304|3132622|Superiority or Other||LS Mean Difference|3.34||||0.4739|2-Sided|95.0|-5.94|12.62|||ANCOVA||||
1703159|NCT00940901|3132643|Superiority or Other|||||||0.55|||||||Fisher Exact||||
1703160|NCT00940901|3132644|Superiority or Other|||||||1|||||||Fisher Exact|||Null hypothesis: there would be no difference in the number of participants who experienced at least a 50% reduction in the frequency of priapic episodes between baseline and 8 weeks post intervention, between the sildenafil and placebo groups|
1703161|NCT00940875|3132648|Superiority or Other||Hazard Ratio (HR)|0.79||||0.5399|2-Sided|95.0|0.38|1.66|||Wald Test||The hazard ratio was estimated using the Cox regression model and stratified by ECOG PS, disease stage, histology, and smoking status.||
1703162|NCT00940875|3132648|Superiority or Other|||||||0.5393|||||||Log Rank|||Difference between treatment groups in OS|
1703163|NCT00940875|3132650|Superiority or Other||Difference in Response Rates|-13.46|||||2-Sided|95.0|-36.0|9.0|||||The 95% CI for difference of 2 rates was determined using the Hauck-Anderson method.|Week 16|
1703164|NCT00940875|3132650|Superiority or Other||Difference in Response Rates|-11.54|||||2-Sided|95.0|-40.3|17.2|||||The 95% CI for difference of 2 rates was determined using the Hauck-Anderson method.|Week 8|
1703165|NCT00940875|3132651|Superiority or Other||Hazard Ratio, log|1.3||||0.4805|2-Sided|95.0|0.63|2.68|||Wald Test||The hazard ratio was estimated using the Cox regression model and stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (PS), disease stage, histology, and smoking status.||
1703166|NCT00940875|3132651|Superiority or Other|||||||0.4798|||||||Log Rank|||Difference between treatment groups in PFS|
1703167|NCT00940875|3132652|Superiority or Other||Difference in Response Rates|-3.3|||||2-Sided|95.0|-17.5|10.9|||||The 95% CI for the difference of 2 rates was estimated using the Hauck-Anderson method.||
1703168|NCT00940771|3132660|Other|Friedman's test||||||0.075||||||a priori threshold for statistical significance 0.05|Friedman's test|3 degrees of freedom|||
1703169|NCT00940771|3132661|Other||Chi-square|1.0||||0.801|2-Sided||||||Friedman's test|3 degrees of freedom|1.0 is the actual calculated Chi-X value, not the p value.|The null hypothesis was that there was a difference. We were looking for no difference between before and after switch.|
1703170|NCT00940771|3132662|Other|Friedman's test with 3 df||||||0.356|||||||Friedman's Test|3 degrees of freedom|||
1703171|NCT00940771|3132663|Other|Post Hoc testing Post hoc Wilcoxon Signed Rank tests||||||0.007|||||||Wilcoxon Signed Rank|Z=-2.701||Nul lHypothesis that there is no difference between specific time points.|
1703172|NCT00940771|3132663|Other|Friedman's Test|Chi Square|12.3||||0.006|2-Sided||||||Friedman's Test|3 degrees of freedom.|||
1703173|NCT00940589|3132664|Superiority or Other||||||<|0.044|||||||ANCOVA||||
1703174|NCT00940589|3132665|Superiority or Other||||||<|0.045|||||||ANCOVA||||
1703175|NCT00940537|3132669|Superiority or Other|||||||0.93||||||The a priori threshold for statistical significance was set at p<0.05.|t-test, 2 sided|||The null hypothesis was that there would be no difference in T2 relaxation ratios for varying levels of intra-hepatic triglyceride (IHTG). Thus the medium (5 - 10%) and high (<10%) IHTG groups would not be statistically different with regard to average T2 ratio.|
1703176|NCT00940537|3132669|Superiority or Other||||||<|0.0001||||||The a priori threshold for statistical significance was p<0.05.|t-test, 2 sided|||null hypothesis was that the T2 ratio would not depend on level of intra-hepatic triglyceride (IHTG) and would be equal for the low (<5%) and high (>10%) IHTG categories.|
1703177|NCT00940537|3132669|Superiority or Other||||||<|0.006||||||This p-value compares the low IHTG (<5%) subjects to those with medium levels of IHTG (5 - 10%). The a priori threshold for statistical significance was p<0.05.|t-test, 2 sided|||null hypothesis was that the T2 ratio would not depend on level of intrahepatic triglyceride (IHTG) and would be equal for the low and medium IHTG categories.|
1703178|NCT00940537|3132670|Superiority or Other|||||||0.097||||||a priori threshhold for significance was set at p<0.05.|t-test, 2 sided|this was a paired t-test||As there was no a priori reason for the level of IHTG to impact this measurement we compared the pre and post-prandial results for all subjects whose data were of sufficient quality (N=12). These results are comparing the two categories of fasting and post-prandial. Null hypothesis was that there would be no difference in IHTG before and after a high fat, high carbohydrate meal.|
1703179|NCT00940290|3132710|Superiority or Other|||||||0.007|||||||Kruskal-Wallis|||After reading the clinical practice guideline, the median response from the four groups were compared using the Kruskal-Wallis statistic|
1703180|NCT00939874|3132757|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1703181|NCT00939731|3132786|Superiority or Other||Ratio of Adjusted Means|98.91|||||2-Sided|90.0|90.18|108.48||||||Natural log transformed Cmax of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CI for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1703182|NCT00939731|3132787|Superiority or Other||Ratio of Adjusted Means|92.43|||||2-Sided|90.0|84.86|100.68||||||Natural log transformed AUC (0-∞) of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1703183|NCT00939731|3132790|Superiority or Other||Ratio of Adjusted Means|92.61|||||2-Sided|90.0|84.84|101.09||||||Natural log transformed AUClast of PF-02341066 was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1703184|NCT00939640|3132801|Superiority|||||||0.02|||||||t-test, 2 sided||||
1703185|NCT00939640|3132802|Superiority|||||||0.006|||||||t-test, 2 sided||||
1703186|NCT00939640|3132807|Superiority or Other (legacy)|||||||0.02|||||||Wilcoxon matched-pairs tests||||
1703187|NCT00939640|3132808|Superiority or Other (legacy)|||||||0.17|||||||Wilcoxon matched-pairs||||
1703188|NCT00939562|3132816|Superiority or Other||Ratio|104.67||||||90.0|98.95|110.73|||||The adjusted mean differences and 90% CIs were exponentiated to provide the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Doxycycline carragenate=Reference, doxycycline monohydrate=Test.|Natural log transformed AUCinf was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).|
1703189|NCT00939562|3132817|Superiority or Other||Ratio|102.95||||||90.0|94.74|111.86|||||The adjusted mean differences and 90% confidence intervals (CIs) were exponentiated to provide the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios. Doxycycline carragenate=Reference, doxycycline monohydrate=Test.|Natural log transformed Cmax was analyzed using a mixed effects model (sequence, period and treatment were fixed effects and subject within sequence was a random effect).|
1703190|NCT00939107|3132902|Superiority or Other||Mean Difference (Net)|1.5|||>|0.05||95.0|0.2|2.8|||t-test, 2 sided||||
1703192|NCT00939029|3132914|Superiority or Other||Odds Ratio (OR)|4.1||||0.014|2-Sided|90.0|1.4|11.6||1 tailed|Regression, Logistic||||
1703193|NCT00939029|3132915|Superiority or Other||Odds Ratio (OR)|2.7||||0.05|2-Sided|90.0|1.0|7.5||1 tailed p-value|Regression, Logistic||||
1703194|NCT00939003|3132919|Superiority or Other|||||||0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.|||
1703195|NCT00939003|3132920|Superiority or Other|||||||0.003|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.|||
1703196|NCT00939003|3132921|Superiority or Other||||||<|0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.|||
1703197|NCT00939003|3132922|Superiority or Other|||||||0.027|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.|||
1703198|NCT00939003|3132923|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1703199|NCT00939003|3132926|Superiority or Other|||||||0.014|||||||Chi-squared||||
1703200|NCT00939003|3132927|Superiority or Other|||||||0.001|||||||ANCOVA|ANCOVA model adjusting for Baseline value with treatment as a factor.|||
1703201|NCT00939003|3132928|Superiority or Other|||||||0.001|||||||Chi-squared||||
1703202|NCT00939003|3132929|Superiority or Other|||||||0.004|||||||Chi-squared||||
1703203|NCT00939003|3132930|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1703204|NCT00938717|3132982|Superiority or Other||Odds Ratio (OR)|3.16|||<|0.0001|2-Sided|95.0|2.22|4.49||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 6/12 Week APC + 1 Responders.~The power, adjusted for multiplicity, was expected to be 86% based on NCT00460811 (MCP-103-202) study data."|
1703205|NCT00938717|3132983|Superiority or Other||Odds Ratio (OR)|2.62|||<|0.0001|2-Sided|95.0|1.91|3.6||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week Abdominal Pain Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.|
1703206|NCT00938717|3132984|Superiority or Other||Odds Ratio (OR)|4.19|||<|0.0001|2-Sided|95.0|2.5|7.03||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week CSBM 3 + 1 Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.|
1703207|NCT00938717|3132985|Superiority or Other||Odds Ratio (OR)|4.65|||<|0.0001|2-Sided|95.0|2.44|8.84||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null Hypothesis: There is no difference between the 290 μg dose and placebo groups in the proportion of 9/12 Week APC 3 + 1 Responders. The power, adjusted for multiplicity, was expected to be 93% based on NCT00460811 (MCP-103-202) study data.|
1703208|NCT00938340|3133065|Superiority or Other|||||||0.92||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703209|NCT00938340|3133065|Superiority or Other|||||||0.0085||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703210|NCT00938340|3133065|Superiority or Other|||||||0.0005||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703211|NCT00938340|3133065|Superiority or Other|||||||0.3||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703212|NCT00938340|3133065|Superiority or Other|||||||0.66||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703213|NCT00938340|3133065|Superiority or Other|||||||0.65||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703214|NCT00938340|3133065|Superiority or Other|||||||0.33||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703215|NCT00938340|3133065|Superiority or Other|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703216|NCT00938340|3133065|Superiority or Other|||||||0.71||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703217|NCT00938340|3133065|Superiority or Other|||||||0.99||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703218|NCT00938340|3133065|Superiority or Other|||||||0.57||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703219|NCT00938340|3133065|Superiority or Other|||||||0.0003||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703220|NCT00938340|3133065|Superiority or Other||||||<|0.0001||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703221|NCT00938340|3133065|Superiority or Other||||||<|0.48||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703222|NCT00938340|3133065|Superiority or Other||||||<|0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703223|NCT00938340|3133065|Superiority or Other||||||<|0.28||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703224|NCT00938340|3133065|Superiority or Other||||||<|0.0089||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703225|NCT00938340|3133065|Superiority or Other||||||<|0.007||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703226|NCT00938340|3133065|Superiority or Other||||||<|0.12||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703227|NCT00938340|3133065|Superiority or Other||||||<|0.91||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703228|NCT00938340|3133065|Superiority or Other||||||<|0.3||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703229|NCT00938340|3133065|Superiority or Other||||||<|0.98||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703230|NCT00938340|3133065|Superiority or Other||||||<|0.31||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703231|NCT00938340|3133065|Superiority or Other||||||<|0.59||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703232|NCT00938340|3133065|Superiority or Other||||||<|0.53||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703233|NCT00938340|3133065|Superiority or Other||||||<|0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703234|NCT00938340|3133065|Superiority or Other||||||<|0.0004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703235|NCT00938340|3133065|Superiority or Other||||||<|0.0011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703236|NCT00938340|3133065|Superiority or Other||||||<|0.21||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703237|NCT00938340|3133065|Superiority or Other||||||<|0.91||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.001667 is considered significant (30 comparisons).|Mixed Models Analysis||||
1703238|NCT00938340|3133065|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1703239|NCT00938340|3133066|Superiority or Other|||||||0.043||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703240|NCT00938340|3133066|Superiority or Other|||||||0.64||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703241|NCT00938340|3133066|Superiority or Other|||||||0.0087||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703242|NCT00938340|3133066|Superiority or Other|||||||0.037||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703243|NCT00938340|3133066|Superiority or Other|||||||0.99||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703244|NCT00938340|3133066|Superiority or Other|||||||0.007||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703245|NCT00938340|3133066|Superiority or Other|||||||0.011|||||||Mixed Models Analysis||||
1703246|NCT00938340|3133067|Superiority or Other|||||||0.62|||||||Mixed Models Analysis||||
1703247|NCT00938340|3133068|Superiority or Other|||||||0.44|||||||Mixed Models Analysis||||
1703248|NCT00938340|3133069|Superiority or Other||||||>|0.05|||||||Mixed Models Analysis||||
1703249|NCT00938340|3133070|Superiority or Other||||||>|0.05|||||||Mixed Models Analysis||||
1703250|NCT00938340|3133071|Superiority or Other||||||>|0.05|||||||Mixed Models Analysis||||
1703251|NCT00938340|3133072|Superiority or Other||||||>|0.05|||||||Mixed Models Analysis||||
1703252|NCT00938340|3133073|Superiority or Other|||||||0.53|||||||Mixed Models Analysis||||
1703253|NCT00938340|3133074|Superiority or Other|||||||0.074||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703254|NCT00938340|3133074|Superiority or Other|||||||0.22||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703255|NCT00938340|3133074|Superiority or Other|||||||0.002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703256|NCT00938340|3133074|Superiority or Other|||||||0.14||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703257|NCT00938340|3133074|Superiority or Other|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703258|NCT00938340|3133074|Superiority or Other|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703259|NCT00938340|3133074|Superiority or Other|||||||0.007|||||||Mixed Models Analysis||||
1703260|NCT00938340|3133075|Superiority or Other|||||||0.16||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703261|NCT00938340|3133075|Superiority or Other|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703262|NCT00938340|3133075|Superiority or Other|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703263|NCT00938340|3133075|Superiority or Other|||||||0.11||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703264|NCT00938340|3133075|Superiority or Other|||||||0.004||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703265|NCT00938340|3133075|Superiority or Other|||||||0.98||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703266|NCT00938340|3133075|Superiority or Other|||||||0.01|||||||Mixed Models Analysis||||
1703267|NCT00938340|3133076|Superiority or Other|||||||0.79|||||||Mixed Models Analysis||||
1703268|NCT00938340|3133077|Superiority or Other|||||||0.15||||||Main effect of treatment by timepoint|Mixed Models Analysis||||
1703269|NCT00938340|3133078|Superiority or Other|||||||0.0013||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703270|NCT00938340|3133078|Superiority or Other|||||||0.0002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703271|NCT00938340|3133078|Superiority or Other|||||||0.62||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703272|NCT00938340|3133078|Superiority or Other|||||||0.011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703273|NCT00938340|3133078|Superiority or Other|||||||0.35||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703274|NCT00938340|3133078|Superiority or Other|||||||0.15||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703275|NCT00938340|3133078|Superiority or Other||||||<|0.01|||||||Mixed Models Analysis||||
1703276|NCT00938340|3133079|Superiority or Other|||||||0.12||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703277|NCT00938340|3133079|Superiority or Other|||||||0.093||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703278|NCT00938340|3133079|Superiority or Other|||||||0.002||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703279|NCT00938340|3133079|Superiority or Other|||||||0.29||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703280|NCT00938340|3133079|Superiority or Other|||||||0.011||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703281|NCT00938340|3133079|Superiority or Other|||||||0.52||||||The Bonferroni adjustment was used to correct for multiple treatment comparisons; P < 0.0083 is considered significant (6 comparisons).|Mixed Models Analysis||||
1703282|NCT00938340|3133079|Superiority or Other|||||||0.012|||||||Mixed Models Analysis||||
1703283|NCT00938041|3133101|Superiority or Other||percentage of participants|25.0|||||2-Sided|95.0|10.0|40.0|||||The estimated value reflects the percentage of participants with confirmed complete response. Percentages are calculated using the number of participants in the ITT-Exposed Population as the denominator.||
1703284|NCT00938041|3133101|Superiority or Other||percentage of participants|25.0|||||2-Sided|95.0|10.0|40.0|||||The estimated value reflects the percentage of participants with complete response. Percentages are calculated using the number of participants in the ITT-Exposed Population as the denominator.||
1703285|NCT00937937|3133130|Superiority or Other (legacy)||6-month PFS estimate|0.07|||||2-Sided|95.0|0.03|0.15||||||6-month PFS estimate.|
1703286|NCT00937937|3133131|Superiority or Other (legacy)||1-year overall survival estimate|0.38|||||2-Sided|95.0|0.27|0.49||||||one-year overall survival estimate.|
1703287|NCT00937326|3133207|Superiority|||||||0.999||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703288|NCT00937326|3133207|Superiority|||||||0.993||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703583|NCT00936065|3133359|Superiority or Other|||||||0.1785|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703584|NCT00936065|3133359|Superiority or Other|||||||0.334|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703289|NCT00937326|3133207|Superiority|||||||0.979||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703290|NCT00937326|3133207|Superiority|||||||0.994||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703291|NCT00937326|3133208|Superiority|||||||0.998||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-percentage of beta cell function.|
1703292|NCT00937326|3133208|Superiority|||||||0.332||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-percentage of beta cell function.|
1703293|NCT00937326|3133208|Superiority|||||||0.622||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-percentage of beta cell function.|
1703294|NCT00937326|3133208|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-percentage of beta cell function.|
1703295|NCT00937326|3133208|Superiority|||||||0.671||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-percentage of beta cell function.|
1703296|NCT00937326|3133208|Superiority|||||||0.404||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-percentage of beta cell function.|
1703297|NCT00937326|3133208|Superiority|||||||0.753||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-percentage of beta cell function.|
1703298|NCT00937326|3133208|Superiority|||||||0.81||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-percentage of beta cell function.|
1703299|NCT00937326|3133209|Superiority|||||||0.763||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703300|NCT00937326|3133209|Superiority|||||||0.999||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703301|NCT00937326|3133209|Superiority|||||||0.989||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703302|NCT00937326|3133209|Superiority|||||||0.996||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703303|NCT00937326|3133210|Superiority|||||||0.86||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-IR.|
1703304|NCT00937326|3133210|Superiority|||||||0.916||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-IR.|
1703585|NCT00936065|3133359|Superiority or Other|||||||0.4636|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703586|NCT00936065|3133359|Superiority or Other|||||||0.1768|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703305|NCT00937326|3133210|Superiority|||||||0.887||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-IR.|
1703306|NCT00937326|3133210|Superiority|||||||0.877||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-IR.|
1703307|NCT00937326|3133210|Superiority|||||||0.989||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-IR.|
1703308|NCT00937326|3133210|Superiority|||||||0.548||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-IR.|
1703309|NCT00937326|3133210|Superiority|||||||0.999||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-IR.|
1703310|NCT00937326|3133210|Superiority|||||||0.992||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-IR.|
1703311|NCT00937326|3133211|Superiority|||||||0.645||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703312|NCT00937326|3133211|Superiority|||||||0.792||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703313|NCT00937326|3133211|Superiority|||||||0.08||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703314|NCT00937326|3133211|Superiority|||||||0.896||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703315|NCT00937326|3133212|Superiority|||||||0.313||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 28 for fructosamine.|
1703316|NCT00937326|3133212|Superiority|||||||0.699||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 28 for fructosamine.|
1703317|NCT00937326|3133212|Superiority|||||||0.164||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 28 for fructosamine.|
1703318|NCT00937326|3133212|Superiority|||||||0.845||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 28 for fructosamine.|
1703319|NCT00937326|3133212|Superiority|||||||0.155||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at Day 1 for fructosamine.|
1703320|NCT00937326|3133212|Superiority|||||||0.901||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at Day 1 for fructosamine.|
1703355|NCT00937326|3133214|Superiority|||||||0.404||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703321|NCT00937326|3133212|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at Day 1 for fructosamine.|
1703322|NCT00937326|3133212|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at Day 1 for fructosamine.|
1703323|NCT00937326|3133213|Superiority|||||||0.2583||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPI.|
1703324|NCT00937326|3133213|Superiority|||||||0.1253||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPI.|
1703325|NCT00937326|3133213|Superiority|||||||0.6452||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPI.|
1703326|NCT00937326|3133213|Superiority|||||||0.6483||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPI.|
1703327|NCT00937326|3133213|Superiority|||||||0.844||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPI.|
1703328|NCT00937326|3133213|Superiority|||||||0.324||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPI.|
1703329|NCT00937326|3133213|Superiority|||||||0.9637||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPI.|
1703330|NCT00937326|3133213|Superiority|||||||0.5997||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPI.|
1703331|NCT00937326|3133213|Superiority|||||||0.196||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI.|
1703332|NCT00937326|3133213|Superiority|||||||0.0564||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPI.|
1703333|NCT00937326|3133213|Superiority|||||||0.322||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPI.|
1703334|NCT00937326|3133213|Superiority|||||||0.5825||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI|
1703335|NCT00937326|3133213|Superiority|||||||0.7663||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPI.|
1703336|NCT00937326|3133213|Superiority|||||||0.2907||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPI.|
1703337|NCT00937326|3133213|Superiority|||||||0.7563||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPI.|
1703338|NCT00937326|3133213|Superiority|||||||0.4829||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPI.|
1703339|NCT00937326|3133213|Superiority|||||||0.2409||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPG.|
1703340|NCT00937326|3133213|Superiority|||||||0.5751||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPG.|
1703341|NCT00937326|3133213|Superiority|||||||0.1214||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPG.|
1703342|NCT00937326|3133213|Superiority|||||||0.9788||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPG.|
1703343|NCT00937326|3133213|Superiority|||||||0.5193||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPG.|
1703344|NCT00937326|3133213|Superiority|||||||0.3286||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPG.|
1703345|NCT00937326|3133213|Superiority|||||||0.1013||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPG.|
1703346|NCT00937326|3133213|Superiority|||||||0.2184||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPG.|
1703347|NCT00937326|3133213|Superiority|||||||0.0975||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 28 for PPG.|
1703348|NCT00937326|3133213|Superiority|||||||0.3369||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPG.|
1703349|NCT00937326|3133213|Other|||||||0.1361||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPG.|
1703350|NCT00937326|3133213|Superiority|||||||0.6711||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPG.|
1703351|NCT00937326|3133213|Superiority|||||||0.6001||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPG.|
1703352|NCT00937326|3133213|Superiority|||||||0.2741||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPG.|
1703353|NCT00937326|3133213|Superiority|||||||0.179||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPG.|
1703354|NCT00937326|3133213|Superiority|||||||0.206||||||No adjustments for covariates were made.|Wilcoxon test|||Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPG.|
1703524|NCT00937040|3133280|Superiority or Other|||||||0.008||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#08.|
1703356|NCT00937326|3133214|Superiority|||||||0.097||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703357|NCT00937326|3133214|Superiority|||||||0.197||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703358|NCT00937326|3133214|Superiority|||||||0.94||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703359|NCT00937326|3133215|Superiority|||||||0.966||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703360|NCT00937326|3133215|Superiority|||||||0.293||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703361|NCT00937326|3133215|Superiority|||||||0.119||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703362|NCT00937326|3133215|Superiority|||||||0.118||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.|||
1703363|NCT00937326|3133216|Superiority|||||||0.883||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 2 hour.|
1703364|NCT00937326|3133216|Superiority|||||||0.923||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 2 hour.|
1703365|NCT00937326|3133216|Superiority|||||||0.985||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 2 hour.|
1703366|NCT00937326|3133216|Superiority|||||||0.955||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 2 hour.|
1703367|NCT00937326|3133216|Superiority|||||||0.142||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 60 minutes.|
1703368|NCT00937326|3133216|Superiority|||||||0.184||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 60 minutes.|
1703369|NCT00937326|3133216|Superiority|||||||0.434||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 60 minutes.|
1703370|NCT00937326|3133216|Superiority|||||||0.765||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 60 minutes.|
1703371|NCT00937326|3133216|Superiority|||||||0.034||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 30 minutes.|
1703525|NCT00937040|3133281|Superiority or Other||||||<|0.001||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#07.|
1703587|NCT00936065|3133359|Superiority or Other|||||||0.4407|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703372|NCT00937326|3133216|Superiority|||||||0.254||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 30 minutes.|
1703373|NCT00937326|3133216|Superiority|||||||0.634||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 30 minutes.|
1703374|NCT00937326|3133216|Superiority|||||||0.464||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 30 minutes.|
1703375|NCT00937326|3133216|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 2 hour.|
1703376|NCT00937326|3133216|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 2 hour.|
1703377|NCT00937326|3133216|Superiority|||||||0.73||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 2 hour.|
1703378|NCT00937326|3133216|Superiority|||||||0.798||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 2 hour.|
1703379|NCT00937326|3133216|Superiority|||||||0.682||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 60 minutes.|
1703380|NCT00937326|3133216|Superiority|||||||0.997||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 60 minutes.|
1703381|NCT00937326|3133216|Superiority|||||||0.864||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 60 minutes.|
1703382|NCT00937326|3133216|Superiority|||||||0.87||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 60 minutes.|
1703383|NCT00937326|3133216|Superiority|||||||0.13||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 30 minutes.|
1703384|NCT00937326|3133216|Superiority|||||||0.989||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 30 minutes.|
1703385|NCT00937326|3133216|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 30 minutes.|
1703386|NCT00937326|3133216|Superiority|||||||0.809||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 30 minutes.|
1703526|NCT00937040|3133282|Superiority or Other||||||<|0.001||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#06.|
1703387|NCT00937326|3133217|Superiority|||||||0.983||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 2 hour for PPI.|
1703388|NCT00937326|3133217|Superiority|||||||0.756||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 2 hour for PPI.|
1703389|NCT00937326|3133217|Superiority|||||||0.876||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 2 hour for PPI.|
1703390|NCT00937326|3133217|Superiority|||||||0.999||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 2 hour for PPI.|
1703391|NCT00937326|3133217|Superiority|||||||0.142||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 60 minutes for PPI.|
1703392|NCT00937326|3133217|Superiority|||||||0.184||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 60 minutes for PPI.|
1703393|NCT00937326|3133217|Superiority|||||||0.434||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 60 minutes for PPI.|
1703394|NCT00937326|3133217|Superiority|||||||0.765||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 60 minutes for PPI.|
1703395|NCT00937326|3133217|Superiority|||||||0.413||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 30 minutes for PPI.|
1703396|NCT00937326|3133217|Superiority|||||||0.365||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 30 minutes for PPI.|
1703397|NCT00937326|3133217|Superiority|||||||0.733||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 30 minutes for PPI.|
1703398|NCT00937326|3133217|Superiority|||||||0.985||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 30 minutes for PPI.|
1703399|NCT00937326|3133217|Superiority|||||||0.96||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 2 hour for PPG.|
1703400|NCT00937326|3133217|Superiority|||||||0.805||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 2 hour for PPG.|
1703401|NCT00937326|3133217|Superiority|||||||0.191||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 2 hour for PPG.|
1703402|NCT00937326|3133217|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 2 hour for PPG.|
1703573|NCT00936065|3133357|Superiority or Other|||||||0.0927|||||||Fisher Exact|||Overall treatment difference at Week 2|
1706580|NCT00887341|3139539|Superiority or Other|||||||0.809|||||||Chi-squared|||Week 8|
1703403|NCT00937326|3133217|Superiority|||||||0.678||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 60 minutes for PPG.|
1703404|NCT00937326|3133217|Superiority|||||||0.852||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 60 minutes for PPG.|
1703405|NCT00937326|3133217|Superiority|||||||0.358||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 60 minutes for PPG.|
1703406|NCT00937326|3133217|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 60 minutes for PPG.|
1703407|NCT00937326|3133217|Superiority|||||||0.198||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day at 30 minutes for PPG.|
1703408|NCT00937326|3133217|Superiority|||||||0.996||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day at 30 minutes for PPG.|
1703409|NCT00937326|3133217|Superiority|||||||0.812||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day at 30 minutes for PPG.|
1703410|NCT00937326|3133217|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day at 30 minutes for PPG.|
1703411|NCT00937326|3133218|Superiority|||||||0.697||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 35.|
1703412|NCT00937326|3133218|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 35.|
1703413|NCT00937326|3133218|Superiority|||||||0.997||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 35.|
1703414|NCT00937326|3133218|Superiority|||||||0.986||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 35.|
1703415|NCT00937326|3133218|Superiority|||||||0.874||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 28.|
1703416|NCT00937326|3133218|Superiority|||||||0.999||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 28.|
1703417|NCT00937326|3133218|Superiority|||||||0.982||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 28.|
1703418|NCT00937326|3133218|Superiority|||||||0.982||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 28.|
1703419|NCT00937326|3133218|Superiority|||||||0.629||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 22.|
1703420|NCT00937326|3133218|Superiority|||||||0.999||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 22.|
1703421|NCT00937326|3133218|Superiority|||||||0.975||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 22.|
1703422|NCT00937326|3133218|Superiority|||||||0.405||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 22.|
1703423|NCT00937326|3133218|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 15.|
1703424|NCT00937326|3133218|Superiority|||||||0.971||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 15.|
1703425|NCT00937326|3133218|Superiority|||||||0.999||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 15.|
1703426|NCT00937326|3133218|Superiority|||||||0.685||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 15.|
1703427|NCT00937326|3133218|Superiority|||||||0.999||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 8.|
1703428|NCT00937326|3133218|Superiority|||||||0.982||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 8.|
1703429|NCT00937326|3133218|Superiority|||||||0.989||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 8.|
1703430|NCT00937326|3133218|Superiority|||||||0.989||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 8.|
1703431|NCT00937326|3133219|Superiority|||||||0.97||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 35 for FPI.|
1703432|NCT00937326|3133219|Superiority|||||||0.929||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 35 for FPI.|
1703433|NCT00937326|3133219|Superiority|||||||0.963||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 35 for FPI.|
1703434|NCT00937326|3133219|Superiority|||||||0.994||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 35 for FPI.|
1703435|NCT00937326|3133219|Superiority|||||||0.991||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 28 for FPI.|
1703436|NCT00937326|3133219|Superiority|||||||0.731||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 28 for FPI.|
1703437|NCT00937326|3133219|Superiority|||||||0.739||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 28 for FPI.|
1703438|NCT00937326|3133219|Superiority|||||||0.973||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 28 for FPI.|
1703439|NCT00937326|3133219|Superiority|||||||0.486||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 22 for FPI.|
1703440|NCT00937326|3133219|Superiority|||||||0.568||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 22 for FPI.|
1703441|NCT00937326|3133219|Superiority|||||||0.687||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 22 for FPI.|
1703442|NCT00937326|3133219|Superiority|||||||0.394||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 22 for FPI.|
1703443|NCT00937326|3133219|Superiority|||||||0.924||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 15 for FPI.|
1703444|NCT00937326|3133219|Superiority|||||||0.949||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 15 for FPI.|
1703445|NCT00937326|3133219|Superiority|||||||0.945||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 15 for FPI.|
1703446|NCT00937326|3133219|Superiority|||||||0.903||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 15 for FPI.|
1703447|NCT00937326|3133219|Superiority|||||||0.688||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 8 for FPI.|
1703448|NCT00937326|3133219|Superiority|||||||0.677||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 8 for FPI.|
1703449|NCT00937326|3133219|Superiority|||||||0.982||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 8 for FPI.|
1703450|NCT00937326|3133219|Superiority|||||||0.999||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 8 for FPI.|
1703574|NCT00936065|3133357|Superiority or Other|||||||0.9429|||||||Fisher Exact|||Overall treatment difference at Baseline|
1706581|NCT00887341|3139539|Superiority or Other|||||||0.121|||||||Chi-squared|||Week 4|
1703451|NCT00937326|3133220|Superiority|||||||0.907||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 35.|
1703452|NCT00937326|3133220|Superiority|||||||0.538||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 35.|
1703453|NCT00937326|3133220|Superiority|||||||0.822||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 35.|
1703454|NCT00937326|3133220|Superiority|||||||0.992||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 35.|
1703455|NCT00937326|3133220|Superiority|||||||0.285||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 28.|
1703456|NCT00937326|3133220|Superiority|||||||0.994||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 28.|
1703457|NCT00937326|3133220|Superiority|||||||0.656||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 28.|
1703458|NCT00937326|3133220|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 28.|
1703459|NCT00937326|3133220|Superiority|||||||0.235||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 22.|
1703460|NCT00937326|3133220|Superiority|||||||0.984||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 22.|
1703461|NCT00937326|3133220|Superiority|||||||0.316||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 22.|
1703462|NCT00937326|3133220|Superiority|||||||0.968||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 22.|
1703463|NCT00937326|3133220|Superiority|||||||0.344||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 15.|
1703464|NCT00937326|3133220|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 15.|
1703465|NCT00937326|3133220|Superiority|||||||0.954||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 15.|
1703575|NCT00936065|3133358|Superiority or Other|||||||0.1247|||||||Fisher Exact|||Overall treatment difference at Week 24|
1703576|NCT00936065|3133358|Superiority or Other|||||||0.1172|||||||Fisher Exact|||Overall treatment difference at Week 18|
1703466|NCT00937326|3133220|Superiority|||||||0.993||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 15.|
1703467|NCT00937326|3133220|Superiority|||||||0.809||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 8.|
1703468|NCT00937326|3133220|Superiority|||||||0.999||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 8.|
1703469|NCT00937326|3133220|Superiority|||||||0.818||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 8.|
1703470|NCT00937326|3133220|Superiority|||||||0.525||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 8.|
1703471|NCT00937326|3133221|Superiority|||||||0.108||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 35 for FPG.|
1703472|NCT00937326|3133221|Superiority|||||||0.603||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 35 for FPG.|
1703473|NCT00937326|3133221|Superiority|||||||0.989||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 35 for FPG.|
1703474|NCT00937326|3133221|Superiority|||||||1||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 35 for FPG.|
1703475|NCT00937326|3133221|Superiority|||||||0.775||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 28 for FPG.|
1703476|NCT00937326|3133221|Superiority|||||||0.393||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 28 for FPG.|
1703477|NCT00937326|3133221|Superiority|||||||0.196||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 28 for FPG.|
1703478|NCT00937326|3133221|Superiority|||||||0.552||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 28 for FPG.|
1703479|NCT00937326|3133221|Superiority|||||||0.732||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 22 for FPG.|
1703480|NCT00937326|3133221|Superiority|||||||0.7||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 22 for FPG.|
1703481|NCT00937326|3133221|Superiority|||||||0.075||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 22 for FPG.|
1703577|NCT00936065|3133358|Superiority or Other|||||||0.0635|||||||Fisher Exact|||Overall treatment difference at Week 12|
1703482|NCT00937326|3133221|Superiority|||||||0.966||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 22 for FPG.|
1703483|NCT00937326|3133221|Superiority|||||||0.939||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 15 for FPG.|
1703484|NCT00937326|3133221|Superiority|||||||0.961||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 15 for FPG.|
1703485|NCT00937326|3133221|Superiority|||||||0.843||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 15 for FPG.|
1703486|NCT00937326|3133221|Superiority|||||||0.85||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 15 for FPG.|
1703487|NCT00937326|3133221|Superiority|||||||0.999||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 2.0 g/day on Day 8 for FPG.|
1703488|NCT00937326|3133221|Superiority|||||||0.987||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 1.0 g/day on Day 8 for FPG.|
1703489|NCT00937326|3133221|Superiority|||||||0.581||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.5 g/day on Day 8 for FPG.|
1703490|NCT00937326|3133221|Superiority|||||||0.997||||||Analysis was performed using ANOVA with Dunnett’s test using the placebo group as the control, a 2-sided alpha of 0.05 was set as the significance threshold. No adjustments for covariates were made.|ANOVA|Dunnett’s test was used to control for inflation of alpha due to multiple comparisons, using the placebo group as the control.||Placebo versus SRT2104 0.25 g/day on Day 8 for FPG.|
1703491|NCT00937326|3133226|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|120.3|||||2-Sided|90.0|88.66|163.23|||||The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 2.0 g/day.|
1703492|NCT00937326|3133226|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|114.79|||||2-Sided|90.0|91.54|143.95|||||The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 1.0 g/day.|
1703493|NCT00937326|3133226|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|94.45|||||2-Sided|90.0|69.07|129.16|||||The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 0.5 g/day.|
1703494|NCT00937326|3133226|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|122.22|||||2-Sided|90.0|86.94|171.8|||||The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for Cmax of SRT2104 0.25 g/day.|
1703495|NCT00937326|3133227|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|117.73|||||2-Sided|90.0|85.14|162.79|||||The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 2.0 g/day.|
1703496|NCT00937326|3133227|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|167.09|||||2-Sided|90.0|120.73|231.25|||||The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 2.0 g/day.|
1703497|NCT00937326|3133227|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|114.46|||||2-Sided|90.0|85.56|153.11|||||The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1for AUC 0-infinity of SRT2104 1.0 g/day.|
1703498|NCT00937326|3133227|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|141.63|||||2-Sided|90.0|111.2|180.39|||||The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 1.0 g/day.|
1703578|NCT00936065|3133358|Superiority or Other|||||||0.2589|||||||Fisher Exact|||Overall treatment difference at Week 8|
1703579|NCT00936065|3133358|Superiority or Other|||||||0.5391|||||||Fisher Exact|||Overall treatment difference at Week 4|
1703499|NCT00937326|3133227|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Other|94.3|||||2-Sided|90.0|70.31|126.48|||||The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. The AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.5 g/day.|
1703500|NCT00937326|3133227|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|133.11|||||2-Sided|90.0|100.55|176.21|||||The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 0.5 g/day.|
1703501|NCT00937326|3133227|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|110.88|||||2-Sided|90.0|88.18|139.43|||||The difference in least squares means and corresponding CI were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI. AUC values included in the analysis were AUC 0-infinity on Day 1 and AUC 0-τ on Day 28.|Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.25 g/day.|
1703502|NCT00937326|3133227|Other|The analysis used an Estimation approach. No hypothesis testing was performed.|Ratio|168.4|||||2-Sided|90.0|123.87|228.94|||||The difference in least squares means and corresponding confidence interval (CI) were back-transformed to form ratio of geometric least squares means (Day 28/ Day 1) and CI.|Day 28 versus Day 1 for AUC 0-t of SRT2104 0.25 g/day.|
1703503|NCT00937326|3133251|Superiority|||||||0.4816||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 2.0 g/day in number of participants with any AE.|
1703504|NCT00937326|3133251|Superiority|||||||1||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 1.0 g/day in number of participants with any AE.|
1703505|NCT00937326|3133251|Superiority|||||||0.1147||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 0.5 g/day in number of participants with any AE.|
1703506|NCT00937326|3133251|Superiority|||||||0.4816||||||No adjustments for covariates were made.|Fisher Exact|||Placebo versus SRT2104 0.25 g/day in number of participants with any AE.|
1703507|NCT00937105|3133263|Superiority or Other||Hazard Ratio (HR)|5.22||||0.04|2-Sided|95.0|1.1|24.7|||Regression, Cox|Multivariate model adjusted for solution, gender and age|referent is no substantial CNS lid bioburden||
1703508|NCT00937105|3133264|Superiority or Other||Hazard Ratio (HR)|2.406||||0.1742|2-Sided|95.0|0.678|8.537||Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|Regression, Cox||referent is no substantial overall lid bioburden||
1703509|NCT00937105|3133265|Superiority or Other||Hazard Ratio (HR)|0.674||||0.5894|2-Sided|95.0|0.161|2.822|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no substantial case bioburden||
1703510|NCT00937105|3133266|Superiority or Other||Hazard Ratio (HR)|1.316||||0.7943|2-Sided|95.0|0.167|10.393|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no corneal staining||
1703511|NCT00937105|3133267|Superiority or Other||Hazard Ratio (HR)|1.737||||0.3923|2-Sided|95.0|0.49|6.156|||Regression, Cox|Univariate hazard ratio provided because non-significant finding did not enter into multivariate analyses|referent is no substantial lens bioburden|To determine if microbial contamination of lenses is a risk factor for CIE|
1703512|NCT00937105|3133268|Superiority or Other||Cumulative Probability of no-CIE|92.8|||||2-Sided|95.0|88.6|96.9||||||Cumulative Unadjusted Probability of Remaining Infiltrate Free in entire Cohort|
1703513|NCT00937040|3133269|Superiority or Other|||||||0.007||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint|
1703514|NCT00937040|3133270|Superiority or Other|||||||0.319||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint|
1703515|NCT00937040|3133271|Superiority or Other||||||<|0.001||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|||P-value for Change from baseline at endpoint|
1703516|NCT00937040|3133272|Superiority or Other|||||||0.284||||||P-value was determined by using the Cochran-Mantel-Haenszel (CMH) row mean scores controlling for center. Missing/unknown responses are not included in the p-value.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#16.|
1703517|NCT00937040|3133273|Superiority or Other|||||||0.092||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#15.|
1703518|NCT00937040|3133274|Superiority or Other|||||||0.016||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#14.|
1703519|NCT00937040|3133275|Superiority or Other|||||||0.003||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#13.|
1703520|NCT00937040|3133276|Superiority or Other||||||<|0.001||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#12.|
1703521|NCT00937040|3133277|Superiority or Other|||||||0.008||||||P-value was determined using CMH general association controlling for pooled center.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#11.|
1703522|NCT00937040|3133278|Superiority or Other||||||<|0.001||||||P-value was determined by using the Cochran-Mantel-Haenszel (CMH) row mean scores controlling for center.|Cochran-Mantel-Haenszel|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#10.|
1703523|NCT00937040|3133279|Superiority or Other|||||||0.372||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#09.|
1703580|NCT00936065|3133358|Superiority or Other|||||||0.1419|||||||Fisher Exact|||Overall treatment difference at Week 2|
1706582|NCT00887341|3139546|Superiority or Other|||||||0.238|||||||Chi-squared||||
1703527|NCT00937040|3133283|Superiority or Other|||||||0.631||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#05.|
1703528|NCT00937040|3133284|Superiority or Other|||||||0.324||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#04.|
1703529|NCT00937040|3133285|Superiority or Other|||||||0.348||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#03.|
1703530|NCT00937040|3133286|Superiority or Other|||||||0.206||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline score. Endpoint for extended day sites is the 4 hour timepoint and for other sites is the last non-missing value after baseline.|ANCOVA|P-value for Change from baseline at endpoint.||Gate-Keeper-Sequence-Number#02.|
1703531|NCT00937040|3133287|Superiority or Other||||||<|0.001||||||P-value was determined by using an ANCOVA model with factors treatment and pooled study center, and covariate baseline AISRS total score. Change from baseline to endpoint uses the latest non-missing score after baseline for each subject.|ANCOVA|P-value for Change from baseline at endpoint. Each outcome involved with gate-keeping will be numbered with a Gate-Keeper-Sequence-Number from 01-16.||Gate-Keeper-Sequence#01. The primary efficacy was tested at the 0.05 level of significance. To control the overall Type I error at 0.05, the secondary efficacy endpoints were tested in a fixed sequence if the preceding null hypothesis was rejected. No further hypotheses could be tested when the preceding null hypothesis was not rejected. All nominal p-values were presented even though the formal testing procedure stopped at the primary endpoint. No unqualified statements can be made.|
1703532|NCT00936975|3133288|Superiority or Other||Slope|32.3288|Standard Error of the Mean|14.6956||0.0278|2-Sided|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations||Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: %Change in Patlak Flux between timepoint 1 and 2 is the same for Normal and Tumor bones|
1703533|NCT00936975|3133288|Superiority or Other||Slope|0.0177|Standard Error of the Mean|0.0097||0.067|2-Sided|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations|Age was included in the model as a confounder|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|H0: Change Patlak Flux from TP1 to TP2 is the same in normal and tumor bones|
1703534|NCT00936975|3133288|Superiority or Other||Slope|0.0061|Standard Error of the Mean|0.0021||0.0033|2-Sided|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|GEE was used to model the change, accounting for 37 bones in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.||
1703535|NCT00936975|3133289|Superiority or Other||Slope|0.0205|Standard Error of the Mean|0.0128||0.1095|2-Sided|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized estimating equations|Age was included in the model as a confounder|Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: influx(Ki) is the same in normal and tumor bones|
1703536|NCT00936975|3133289|Superiority or Other||Slope|0.0017|Standard Error of the Mean|0.0027||0.53|2-Sided||||||Generalized Estimating Equation|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.||
1703537|NCT00936975|3133290|Superiority or Other||Slope|-0.0177|Standard Error of the Mean|0.0125||0.16|2-Sided|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.||
1703538|NCT00936975|3133291|Superiority or Other||Slope|6.98|Standard Error of the Mean|1.6943|<|0.001|2-Sided|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equations|Age was included in the model as a confounder|Estimated value is the slope of the Normal bone. Tumor Bone was used as reference category. GEEs, rather than a simple mean difference, were used to account for clustering and correlation of bone measurement values within a patient|H0: No difference in uptake b/w normal & tumor bones|
1703581|NCT00936065|3133358|Superiority or Other|||||||0.5377|||||||Fisher Exact|||Overall treatment difference at Baseline|
1703582|NCT00936065|3133359|Superiority or Other|||||||0.7428|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1708380|NCT00858247|3143271|Superiority or Other|||||||0.65|||||||ANCOVA||||
1703539|NCT00936975|3133291|Superiority or Other||Slope|0.33|Standard Error of the Mean|0.3274|<|0.32|2-Sided|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|Generalized Estimating Equation|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.||
1703540|NCT00936975|3133292|Superiority or Other||Slope|-0.0115|Standard Error of the Mean|0.0089||0.1945|2-Sided|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|GEE|GEE was used to model the change, accounting for 37 tumors in 12 patients measured at 2 time points.|GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|the difference in Patlak flux in tumor bone between baseline and 12 weeks, accounting for the fact that each participant could contribute more than one tumor bone.|
1703541|NCT00936975|3133293|Superiority or Other||Slope|-6.6084|Standard Error of the Mean|1.7644|<|0.001|2-Sided|||||GEEs were used to model the change in tumor uptake between baseline and 12 weeks. GEEs were used to adjust for the correlation of 37 tumors in 12 patients measured at 2 time points and to adjust for age as a confounder.|GEE||GEEs, rather than a simple mean difference, were used to account for the multiple (clustered) bone measurement values within a patient and to adjust for age so that appropriate SE estimates (and thus p-values) were produced.|This was an exploratory study and no a priori assumptions were employed.|
1703542|NCT00936897|3133298|Superiority or Other||Mean Difference (Net)|2.0|||<|0.0001|2-Sided|95.0|1.5|2.5|||ANCOVA||Denosumab - Ibandronate||
1703543|NCT00936897|3133299|Superiority or Other||Mean Difference (Net)|1.2|||<|0.0001|2-Sided|95.0|0.7|1.7|||ANCOVA||Denosumab - Ibandronate||
1703544|NCT00936897|3133300|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1703545|NCT00936897|3133301|Superiority or Other||Mean Difference (Net)|1.4|||<|0.0001|2-Sided|95.0|1.0|1.8|||ANCOVA||Denosumab - Ibandronate||
1703546|NCT00936884|3133302|Superiority or Other (legacy)||Odds Ratio (OR)|23.38|||<|0.0001|2-Sided|97.5|10.91|50.14||Comparison of the MNTX group and the placebo group in the proportion of subjects having a RFBM within 4 hours after each injection was performed by using a 2-sided Cochran-Mantel-Haenszel Chi square test at the alpha level of 0.025.|Chi-squared||||
1703547|NCT00936884|3133303|Superiority or Other (legacy)||Mean Difference (Final Values)|56.64|||<|0.0001|2-Sided|97.5|40.62|72.66||Comparison of the MNTX group and the placebo group was based on ANOVA model with the proportion of injections resulting in RFBM within 4 hours during the double-blind period as the dependent variable and the treatment group as the fixed effect. .|ANOVA||Estimated value is the difference in least squared means for MNTX vs. placebo (MNTX minus placebo). Based on the ANOVA model, there is 97.5% confidence that the difference between MNTX and placebo falls between the lower and upper limits presented.||
1703548|NCT00936884|3133304|Superiority or Other (legacy)||Odds Ratio (OR)|83.6|||<|0.0001|2-Sided|97.5|6.5|1074.7||Comparison of the MNTX group and the placebo group in the proportion of subjects having a RFBM within 4 hours after the first injection was performed by using a 2-sided Cochran-Mantel-Haenszel Chi square test at the alpha level of 0.025.|Chi-squared||||
1703549|NCT00936377|3133331|Superiority or Other|||||||0.64|||||||Wilcoxon (Mann-Whitney)||||
1703550|NCT00936377|3133331|Superiority or Other|||||||0.43|||||||Wilcoxon (Mann-Whitney)||||
1703551|NCT00936377|3133332|Superiority or Other|||||||0.95|||||||Wilcoxon (Mann-Whitney)||||
1703552|NCT00936377|3133332|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1703553|NCT00936377|3133333|Superiority or Other||||||<|0.05|||||||Repeated measures ANOVA||||
1703554|NCT00936377|3133334|Superiority or Other|||||||0.2|||||||Fisher Exact|||For bradycardia|
1703555|NCT00936377|3133334|Superiority or Other|||||||1|||||||Fisher Exact|||For bradycardia|
1703556|NCT00936377|3133334|Superiority or Other|||||||0.47|||||||Fisher Exact|||For hypotension|
1703557|NCT00936377|3133334|Superiority or Other|||||||1|||||||Fisher Exact|||For hypotension|
1703558|NCT00936377|3133335|Superiority or Other|||||||0.35||||||Percentage of CIWA scores rates as severe|Chi-squared, Corrected||||
1703559|NCT00936377|3133335|Superiority or Other|||||||0.18||||||Percentage of CIWA scores rates as severe|Chi-squared, Corrected|||Percentage of CIWA scores rates as severe|
1703560|NCT00936377|3133336|Superiority or Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1703561|NCT00936377|3133336|Superiority or Other|||||||0.066|||||||Wilcoxon (Mann-Whitney)||||
1703562|NCT00936377|3133337|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1703563|NCT00936377|3133337|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1703564|NCT00936377|3133338|Superiority or Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1703565|NCT00936377|3133338|Superiority or Other|||||||0.64|||||||Wilcoxon (Mann-Whitney)||||
1703566|NCT00936351|3133341|Superiority or Other||Mean Difference (Final Values)|2.21||||0.04|2-Sided||||||t-test, 2 sided||||
1703567|NCT00936221|3133348|Superiority or Other||Hazard Ratio (HR)|0.93||||0.3873|2-Sided|80.0|0.67|1.28||1-sided p-value|Regression, Cox|Cox model adjusting for treatment, WHO performance status, LDH, M status and tumour sub-type.||If the true hazard ratio (HR) is 0.57, 58 deaths provides at least 80% power to demonstrate a statistically significant difference for OS, assuming a 1-sided 10% significance level.|
1703568|NCT00936065|3133357|Superiority or Other|||||||0.0176|||||||Fisher Exact|||Overall treatment difference at Week 24|
1703569|NCT00936065|3133357|Superiority or Other|||||||0.0237|||||||Fisher Exact|||Overall treatment difference at Week 18|
1703570|NCT00936065|3133357|Superiority or Other|||||||0.0242|||||||Fisher Exact|||Overall treatment difference at Week 12|
1703571|NCT00936065|3133357|Superiority or Other|||||||0.1124|||||||Fisher Exact|||Overall treatment difference at Week 8|
1703572|NCT00936065|3133357|Superiority or Other|||||||0.0151|||||||Fisher Exact|||Overall treatment difference at Week 4|
1703588|NCT00936065|3133360|Superiority or Other|||||||0.3415|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703589|NCT00936065|3133360|Superiority or Other|||||||0.138|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703590|NCT00936065|3133360|Superiority or Other|||||||0.0337|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703591|NCT00936065|3133360|Superiority or Other|||||||0.0727|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703592|NCT00936065|3133360|Superiority or Other|||||||0.0084|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703593|NCT00936065|3133360|Superiority or Other|||||||0.0894|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703594|NCT00936065|3133361|Superiority or Other|||||||0.041|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703595|NCT00936065|3133361|Superiority or Other|||||||0.025|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703596|NCT00936065|3133361|Superiority or Other|||||||0.001|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703597|NCT00936065|3133361|Superiority or Other|||||||0.0104|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703598|NCT00936065|3133361|Superiority or Other|||||||0.1184|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703599|NCT00936065|3133361|Superiority or Other|||||||0.3402|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703600|NCT00936065|3133362|Superiority or Other|||||||0.0393|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703601|NCT00936065|3133362|Superiority or Other|||||||0.1241|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703602|NCT00936065|3133362|Superiority or Other|||||||0.0062|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703603|NCT00936065|3133362|Superiority or Other|||||||0.0899|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703604|NCT00936065|3133362|Superiority or Other|||||||0.0341|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703605|NCT00936065|3133362|Superiority or Other|||||||0.3355|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703606|NCT00936065|3133363|Superiority or Other|||||||0.0116|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703607|NCT00936065|3133363|Superiority or Other|||||||0.009|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703608|NCT00936065|3133363|Superiority or Other|||||||0.0424|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703609|NCT00936065|3133363|Superiority or Other|||||||0.201|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703610|NCT00936065|3133363|Superiority or Other|||||||0.145|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703611|NCT00936065|3133363|Superiority or Other|||||||0.0409|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703612|NCT00936065|3133364|Superiority or Other|||||||0.1982|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703613|NCT00936065|3133364|Superiority or Other|||||||0.2211|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703614|NCT00936065|3133364|Superiority or Other|||||||0.0445|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703615|NCT00936065|3133364|Superiority or Other|||||||0.0742|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703616|NCT00936065|3133364|Superiority or Other|||||||0.009|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703617|NCT00936065|3133364|Superiority or Other|||||||0.0202|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703618|NCT00936065|3133365|Superiority or Other|||||||0.3415|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703619|NCT00936065|3133365|Superiority or Other|||||||0.2073|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703620|NCT00936065|3133365|Superiority or Other|||||||0.0935|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703621|NCT00936065|3133365|Superiority or Other|||||||0.0946|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703622|NCT00936065|3133365|Superiority or Other|||||||0.0024|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703623|NCT00936065|3133365|Superiority or Other|||||||0.0512|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703624|NCT00936065|3133366|Superiority or Other|||||||0.0205|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703625|NCT00936065|3133366|Superiority or Other|||||||0.0475|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703626|NCT00936065|3133366|Superiority or Other|||||||0.0026|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703627|NCT00936065|3133366|Superiority or Other|||||||0.0383|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703628|NCT00936065|3133366|Superiority or Other|||||||0.0142|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703629|NCT00936065|3133366|Superiority or Other|||||||0.2691|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703630|NCT00936065|3133367|Superiority or Other|||||||0.3822|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703631|NCT00936065|3133367|Superiority or Other|||||||0.2293|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703632|NCT00936065|3133367|Superiority or Other|||||||0.5084|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703633|NCT00936065|3133367|Superiority or Other|||||||0.4753|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703634|NCT00936065|3133367|Superiority or Other|||||||0.404|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703635|NCT00936065|3133367|Superiority or Other|||||||0.476|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703636|NCT00936065|3133368|Superiority or Other|||||||0.4189|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703637|NCT00936065|3133368|Superiority or Other|||||||0.4976|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703638|NCT00936065|3133368|Superiority or Other|||||||0.6777|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703639|NCT00936065|3133368|Superiority or Other|||||||0.3837|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703640|NCT00936065|3133368|Superiority or Other|||||||0.4149|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703641|NCT00936065|3133368|Superiority or Other|||||||0.3287|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703642|NCT00936065|3133369|Superiority or Other|||||||0.549|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703643|NCT00936065|3133369|Superiority or Other|||||||0.2582|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703644|NCT00936065|3133369|Superiority or Other|||||||0.6085|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703645|NCT00936065|3133369|Superiority or Other|||||||0.435|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703646|NCT00936065|3133369|Superiority or Other|||||||0.4509|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703647|NCT00936065|3133369|Superiority or Other|||||||0.1144|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703648|NCT00936065|3133370|Superiority or Other|||||||0.8662|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703649|NCT00936065|3133370|Superiority or Other|||||||0.4765|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703650|NCT00936065|3133370|Superiority or Other|||||||0.5071|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703651|NCT00936065|3133370|Superiority or Other|||||||0.2199|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703652|NCT00936065|3133370|Superiority or Other|||||||0.7021|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703653|NCT00936065|3133370|Superiority or Other|||||||0.6904|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703654|NCT00936065|3133371|Superiority or Other|||||||0.0132|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703655|NCT00936065|3133371|Superiority or Other|||||||0.0096|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703656|NCT00936065|3133371|Superiority or Other|||||||0.0068|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703657|NCT00936065|3133371|Superiority or Other|||||||0.0127|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703658|NCT00936065|3133371|Superiority or Other|||||||0.0058|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703659|NCT00936065|3133371|Superiority or Other|||||||0.006|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703660|NCT00936065|3133372|Superiority or Other|||||||0.041|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703661|NCT00936065|3133372|Superiority or Other|||||||0.1553|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703662|NCT00936065|3133372|Superiority or Other|||||||0.0077|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703663|NCT00936065|3133372|Superiority or Other|||||||0.0711|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703664|NCT00936065|3133372|Superiority or Other|||||||0.098|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703665|NCT00936065|3133372|Superiority or Other|||||||0.0302|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703666|NCT00936065|3133373|Superiority or Other|||||||0.2094|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703667|NCT00936065|3133373|Superiority or Other|||||||0.1567|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703668|NCT00936065|3133373|Superiority or Other|||||||0.003|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703669|NCT00936065|3133373|Superiority or Other|||||||0.0606|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703670|NCT00936065|3133373|Superiority or Other|||||||0.1195|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703671|NCT00936065|3133373|Superiority or Other|||||||0.1774|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703672|NCT00936065|3133374|Superiority or Other|||||||0.2184|||||||Kruskal-Wallis|||Overall treatment difference at Week 24|
1703673|NCT00936065|3133374|Superiority or Other|||||||0.0603|||||||Kruskal-Wallis|||Overall treatment difference at Week 18|
1703674|NCT00936065|3133374|Superiority or Other|||||||0.0035|||||||Kruskal-Wallis|||Overall treatment difference at Week 12|
1703675|NCT00936065|3133374|Superiority or Other|||||||0.0109|||||||Kruskal-Wallis|||Overall treatment difference at Week 8|
1703676|NCT00936065|3133374|Superiority or Other|||||||0.0196|||||||Kruskal-Wallis|||Overall treatment difference at Week 4|
1703677|NCT00936065|3133374|Superiority or Other|||||||0.3112|||||||Kruskal-Wallis|||Overall treatment difference at Week 2|
1703678|NCT00936065|3133375|Superiority or Other|||||||0.0493|||||||ANCOVA|||Overall treatment difference at Week 24|
1703679|NCT00936065|3133375|Superiority or Other|||||||0.0685|||||||ANCOVA|||Overall treatment difference at Week 18|
1703680|NCT00936065|3133375|Superiority or Other|||||||0.0565|||||||ANCOVA|||Overall treatment difference at Week 12|
1703681|NCT00936065|3133375|Superiority or Other|||||||0.1578|||||||ANCOVA|||Overall treatment difference at Week 8|
1703682|NCT00936065|3133375|Superiority or Other|||||||0.0136|||||||ANCOVA|||Overall treatment difference at Week 4|
1703683|NCT00936065|3133375|Superiority or Other|||||||0.1229|||||||ANCOVA|||Overall treatment difference at Week 2|
1703684|NCT00936065|3133376|Superiority or Other|||||||0.0197|||||||ANCOVA|||Overall treatment difference at Week 24|
1703685|NCT00936065|3133376|Superiority or Other|||||||0.0062|||||||ANCOVA|||Overall treatment difference at Week 18|
1703686|NCT00936065|3133376|Superiority or Other|||||||0.0019|||||||ANCOVA|||Overall treatment difference at Week 12|
1703687|NCT00936065|3133376|Superiority or Other|||||||0.0146|||||||ANCOVA|||Overall treatment difference at Week 8|
1703688|NCT00936065|3133376|Superiority or Other|||||||0.0004|||||||ANCOVA|||Overall treatment difference at Week 4|
1703689|NCT00936065|3133376|Superiority or Other|||||||0.1079|||||||ANCOVA|||Overall treatment difference at Week 2|
1703690|NCT00936065|3133377|Superiority or Other|||||||0.0394|||||||ANCOVA|||Overall treatment difference at Week 24|
1703691|NCT00936065|3133377|Superiority or Other|||||||0.482|||||||ANCOVA|||Overall treatment difference at Week 18|
1703692|NCT00936065|3133377|Superiority or Other|||||||0.5678|||||||ANCOVA|||Overall treatment difference at Week 12|
1703693|NCT00936065|3133377|Superiority or Other|||||||0.0908|||||||ANCOVA|||Overall treatment difference at Week 8|
1703694|NCT00936065|3133377|Superiority or Other|||||||0.0292|||||||ANCOVA|||Overall treatment difference at Week 4|
1703695|NCT00936065|3133377|Superiority or Other|||||||0.1723|||||||ANCOVA|||Overall treatment difference at Week 2|
1703696|NCT00936065|3133378|Superiority or Other|||||||0.0539|||||||ANCOVA|||Overall treatment difference at Week 24|
1703697|NCT00936065|3133378|Superiority or Other|||||||0.0454|||||||ANCOVA|||Overall treatment difference at Week 18|
1703698|NCT00936065|3133378|Superiority or Other|||||||0.0034|||||||ANCOVA|||Overall treatment difference at Week 12|
1703699|NCT00936065|3133378|Superiority or Other|||||||0.0442|||||||ANCOVA|||Overall treatment difference at Week 8|
1703700|NCT00936065|3133378|Superiority or Other|||||||0.0019|||||||ANCOVA|||Overall treatment difference at Week 4|
1703701|NCT00936065|3133378|Superiority or Other|||||||0.1385|||||||ANCOVA|||Overall treatment difference at Week 2|
1703702|NCT00936065|3133379|Superiority or Other|||||||0.1205|||||||ANCOVA|||Overall treatment difference at Week 24|
1703703|NCT00936065|3133379|Superiority or Other|||||||0.0543|||||||ANCOVA|||Overall treatment difference at Week 18|
1703704|NCT00936065|3133379|Superiority or Other|||||||0.0241|||||||ANCOVA|||Overall treatment difference at Week 12|
1703705|NCT00936065|3133379|Superiority or Other|||||||0.0598|||||||ANCOVA|||Overall treatment difference at Week 8|
1703706|NCT00936065|3133379|Superiority or Other|||||||0.0003|||||||ANCOVA|||Overall treatment difference at Week 4|
1703707|NCT00936065|3133379|Superiority or Other|||||||0.0329|||||||ANCOVA|||Overall treatment difference at Week 2|
1703708|NCT00936065|3133380|Superiority or Other|||||||0.0058|||||||ANCOVA|||Overall treatment difference at Week 24|
1703709|NCT00936065|3133380|Superiority or Other|||||||0.0066|||||||ANCOVA|||Overall treatment difference at Week 18|
1703710|NCT00936065|3133380|Superiority or Other|||||||0.0006|||||||ANCOVA|||Overall treatment difference at Week 12|
1703711|NCT00936065|3133380|Superiority or Other|||||||0.0056|||||||ANCOVA|||Overall treatment difference at Week 8|
1703712|NCT00936065|3133380|Superiority or Other|||||||0.0102|||||||ANCOVA|||Overall treatment difference at Week 4|
1703713|NCT00936065|3133380|Superiority or Other|||||||0.0203|||||||ANCOVA|||Overall treatment difference at Week 2|
1703714|NCT00936065|3133381|Superiority or Other|||||||0.3536|||||||Log Rank|||Overall treatment difference|
1703715|NCT00936065|3133382|Superiority or Other|||||||0.0041|||||||Log Rank|||Overall treatment difference|
1703716|NCT00936065|3133383|Superiority or Other|||||||0.0448|||||||Log Rank|||Overall treatment difference|
1703717|NCT00936065|3133384|Superiority or Other|||||||0.0033|||||||Log Rank|||Overall treatment difference|
1703718|NCT00936065|3133385|Superiority or Other|||||||0.0031|||||||Fisher Exact|||Overall treatment difference at Week 24|
1703719|NCT00936065|3133385|Superiority or Other|||||||0.0055|||||||Fisher Exact|||Overall treatment difference at Week 18|
1703720|NCT00936065|3133385|Superiority or Other|||||||0.0063|||||||Fisher Exact|||Overall treatment difference at Week 12|
1703721|NCT00936065|3133385|Superiority or Other|||||||0.1081|||||||Fisher Exact|||Overall treatment difference at Week 8|
1703722|NCT00936065|3133385|Superiority or Other|||||||0.1119|||||||Fisher Exact|||Overall treatment difference at Week 4|
1703723|NCT00936065|3133385|Superiority or Other|||||||0.2971|||||||Fisher Exact|||Overall treatment difference at Week 2|
1703724|NCT00936065|3133385|Superiority or Other|||||||0.6061|||||||Fisher Exact|||Overall treatment difference at Baseline|
1703725|NCT00936065|3133386|Superiority or Other|||||||0.0374|||||||Fisher Exact|||Overall treatment difference at Week 24|
1703726|NCT00936065|3133386|Superiority or Other|||||||0.5038|||||||Fisher Exact|||Overall treatment difference at Week 18|
1703727|NCT00936065|3133386|Superiority or Other|||||||0.0272|||||||Fisher Exact|||Overall treatment difference at Week 12|
1703728|NCT00936065|3133386|Superiority or Other|||||||0.1961|||||||Fisher Exact|||Overall treatment difference at Week 8|
1703729|NCT00936065|3133386|Superiority or Other|||||||0.4763|||||||Fisher Exact|||Overall treatment difference at Week 4|
1703730|NCT00936065|3133386|Superiority or Other|||||||0.3103|||||||Fisher Exact|||Overall treatment difference at Week 2|
1703731|NCT00936065|3133387|Superiority or Other|||||||1|||||||Fisher Exact|||Overall treatment difference at Week 24|
1703732|NCT00936065|3133387|Superiority or Other|||||||1|||||||Fisher Exact|||Overall treatment difference at Week 18|
1703733|NCT00936065|3133387|Superiority or Other|||||||0.323|||||||Fisher Exact|||Overall treatment difference at Week 12|
1703734|NCT00936065|3133387|Superiority or Other|||||||1|||||||Fisher Exact|||Overall treatment difference at Week 8|
1703735|NCT00936065|3133388|Superiority or Other|||||||0.0366|||||||Fisher Exact|||Overall treatment difference Week 24|
1703736|NCT00936065|3133388|Superiority or Other|||||||0.0105|||||||Fisher Exact|||Overall treatment difference Week 18|
1703737|NCT00936065|3133388|Superiority or Other|||||||0.0004|||||||Fisher Exact|||Overall treatment difference Week 12|
1703738|NCT00936065|3133388|Superiority or Other|||||||0.0256|||||||Fisher Exact|||Overall treatment difference Week 8|
1703739|NCT00936065|3133388|Superiority or Other|||||||0.0229|||||||Fisher Exact|||Overall treatment difference Week 4|
1703740|NCT00936065|3133388|Superiority or Other|||||||1|||||||Fisher Exact|||Overall treatment difference Week 2|
1703741|NCT00936065|3133389|Superiority or Other|||||||0.0672|||||||Fisher Exact|||Overall treatment difference|
1703742|NCT00935818|3133397|Superiority or Other||Odds Ratio (OR)|1.4||||0.08|2-Sided|95.0|0.96|2.05|||Regression, Logistic|||Logistic Regression - adjusting for site|
1703743|NCT00935818|3133398|Superiority or Other||Odds Ratio (OR)|1.39||||0.11|2-Sided|95.0|0.93|2.07|||Regression, Logistic|||Logistic Regression - adjusting for study site|
1703744|NCT00935818|3133399|Superiority or Other||Odds Ratio (OR)|1.32||||0.14|2-Sided|95.0|0.91|1.91|||Regression, Logistic|||Logistic Regression adjusting for study site|
1704614|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.23||||0.6306|2-Sided||||||Cochran-Mantel-Haenszel|||Week 12|
1703745|NCT00935818|3133400|Superiority or Other||Odds Ratio (OR)|1.36||||0.09|2-Sided|95.0|0.95|1.93|||Regression, Logistic|||Logistic regression adjusted for study site|
1703746|NCT00935818|3133401|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1703747|NCT00935818|3133402|Superiority or Other||Odds Ratio (OR)|1.52||||0.03|2-Sided|95.0|1.04|2.22|||Regression, Logistic|||Logistic Regression - adjusting for study site|
1703748|NCT00935818|3133403|Superiority or Other||Odds Ratio (OR)|1.49||||0.03|2-Sided|95.0|1.05|2.12|||Regression, Logistic|||Logistic regression with covariate included for study site.|
1703749|NCT00935792|3133409|Other||||||||||||||||||Estimated maximum tolerated dose was 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
1703750|NCT00935766|3133411|Superiority or Other|||||||0.36|||||||Mixed Models Analysis||||
1703751|NCT00935766|3133412|Superiority or Other|||||||0.08|||||||Mixed Models Analysis||||
1703752|NCT00935766|3133413|Superiority or Other|||||||0.21|||||||Mixed Models Analysis||||
1703753|NCT00935701|3133414|Superiority or Other|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Total Stress|
1703754|NCT00935701|3133414|Superiority or Other|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Parent Domain Total|
1703755|NCT00935701|3133414|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Child Domain Total|
1703756|NCT00935701|3133415|Superiority or Other|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Total Disturbance|
1703757|NCT00935701|3133415|Superiority or Other|||||||0.31|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Daytime Sleepiness subscale|
1703758|NCT00935701|3133415|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Parasomnias subscale|
1703759|NCT00935701|3133415|Superiority or Other|||||||0.66|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Night Wakings subscale|
1703760|NCT00935701|3133415|Superiority or Other|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Anxiety subscale|
1703761|NCT00935701|3133415|Superiority or Other|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Duration subscale|
1703762|NCT00935701|3133415|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Sleep Onset Delay subscale|
1703763|NCT00935701|3133415|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Bedtime Resistance subscale|
1703764|NCT00935701|3133416|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Total|
1703765|NCT00935701|3133416|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Hyperactive-Impulsive subscale|
1703766|NCT00935701|3133416|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on DSM-IV Inattentive subscale|
1703767|NCT00935701|3133416|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Global Index Total|
1703768|NCT00935701|3133416|Superiority or Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Emotional Lability subscale|
1703769|NCT00935701|3133416|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Mean change in score from pre to post on Restless-Impulsive subscale|
1703770|NCT00935584|3133421|Superiority or Other||||||<|0.05|||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.|
1703771|NCT00935584|3133421|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.|
1703772|NCT00935584|3133422|Superiority or Other||||||<|0.05|||||||Wilcoxon signed rank test|||The null hypothesis is that there is no significant change in outcome from pre to post visit.|
1703773|NCT00935584|3133422|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in outcome from pre to post visit.|
1703774|NCT00935584|3133423|Superiority or Other||||||<|0.05|||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.|
1703775|NCT00935584|3133423|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.|
1703776|NCT00935584|3133424|Superiority or Other||||||>|0.05|||||||Wilcoxon signed rank test|||The null hypothesis is that there is no significant change in patient engagement from pre to post visit.|
1703777|NCT00935584|3133424|Superiority or Other||||||>|0.05|||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in patient engagement from pre to post visit.|
1703778|NCT00935584|3133425|Superiority or Other||||||>|0.05|||||||Wicoxon signed rank test|||The null hypothesis is that there is no significant change in outcome from pre to post visit.|
1703779|NCT00935584|3133425|Superiority or Other||||||>|0.05|||||||Mixed Models Analysis|||The null hypothesis is that there is no significant change in outcome from pre to post visit.|
1703780|NCT00935584|3133426|Superiority or Other||||||>|0.05|||||||Wilcoxon signed rank test|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.|
1703781|NCT00935584|3133426|Superiority or Other||||||>|0.05|||||||Mixed Models Analysis|||The null hypothesis states that there is no significant change in outcome from pre-intervention clinical visit (baseline) to post-intervention clinic visit.|
1703804|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|-4.7|||<|0.07||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 22:5n3|
1703782|NCT00935532|3133430|Superiority or Other||Geometric Least Squares Mean Ratio|1.0|Standard Error of the Mean|1.03||0.99|2-Sided|95.0|0.94|1.06|||ANCOVA|||Triglycerides data were logarithm-transformed and the change at endpoint to baseline, expressed as the ratio, was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline triglycerides as a covariate.|
1703783|NCT00935532|3133431|Superiority or Other||Least Squares Mean Difference|-0.28|Standard Error of the Mean|0.69||0.689|2-Sided|95.0|-1.64|1.09|||ANCOVA|||Change in HDL-C from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pre-treatment with SU as factors and baseline HDL-C as a covariate.|
1703784|NCT00935532|3133432|Superiority or Other||Least Squares Mean Difference|-7.89|Standard Error of the Mean|2.26|<|0.001|2-Sided|95.0|-12.33|-3.45|||ANCOVA|||Change in total cholesterol from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline total cholesterol as a covariate.|
1703785|NCT00935532|3133433|Superiority or Other||Least Squares Mean Difference|-2.01|Standard Error of the Mean|0.23|<|0.001|2-Sided|95.0|-2.46|-1.56|||ANCOVA|||Change in body weight from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline body weight as a covariate.|
1703786|NCT00935532|3133434|Superiority or Other||Least Squares Mean Difference|-5.28|Standard Error of the Mean|3.23||0.103|2-Sided|95.0|-11.62|1.07|||ANCOVA|||Change in FSG from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, background OAD, and presence/absence of pretreatment with SU as factors and baseline FSG as a covariate.|
1703787|NCT00935532|3133435|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Percentage of subjects achieving HbA1c<=6.5% at endpoint were compared between treatments using a CMH test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.|
1703788|NCT00935532|3133436|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Percentage of subjects achieving HbA1c<=7% at endpoint were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and presence/absence of pretreatment with SU served as the stratification factors.|
1703789|NCT00935532|3133437|Non-Inferiority or Equivalence|Noninferiority of exenatide QW to insulin glargine with respect to change in HbA1c was to be concluded if the upper limit of the 95% confidence interval (CI) for the treatment difference was less than 0.4%. Change in HbA1c from baseline to endpoint was analyzed using a LOCF ANCOVA model with treatment, baseline HbA1c stratum (<8.5%, >=8.5%), background OAD, and presence/absence of pretreatment with SU as factors and baseline HbA1c as a covariate.|Least Squares Mean Difference|-0.43|Standard Error of the Mean|0.08|<|0.001|2-Sided|95.0|-0.59|-0.26||No adjustments for multiplicity will be performed|ANCOVA|||The expected changes in HbA1c from baseline were considered to be the same between the groups, and the common standard deviation assumed to be 1.2%. Assuming a type I error of 0.025 (one-sided), a power of 0.9 and a noninferiority margin of 0.4%, 191 subjects per group would be necessary to confirm the noninferiority by the two-sample t-test. When the proportion of the subjects missing post-baseline data was assumed to be 10%, the target number of subjects were 420 in total (210 subjects/group).|
1703790|NCT00935493|3133438|Superiority or Other|||||||0.46|||||||Regression, Linear||||
1703791|NCT00935493|3133438|Superiority or Other|||||||0.65|||||||Regression, Linear||||
1703792|NCT00935493|3133439|Superiority or Other|||||||0.46|||||||Regression, Logistic||||
1703793|NCT00935493|3133439|Superiority or Other|||||||0.67|||||||Regression, Logistic||||
1703794|NCT00935493|3133440|Superiority or Other|||||||0.47|||||||Regression, Linear||||
1703795|NCT00935493|3133440|Superiority or Other|||||||0.06|||||||Regression, Linear||||
1703796|NCT00935259|3133453|Superiority or Other|||||||0.151|||||||Mixed Models Analysis|||Cholesterol ester c20:5n3 / c20:4n3|
1703797|NCT00935259|3133453|Superiority or Other|||||||0.247|||||||Mixed Models Analysis|||Cholesterol ester c20:4n6 / c20:3n6|
1703798|NCT00935259|3133455|Superiority or Other||Mean Difference (Final Values)|1.4|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Fed|
1703799|NCT00935259|3133455|Superiority or Other||Mean Difference (Final Values)|0.9|||<|0.027||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Fasted|
1703800|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|0.1||||0.833||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Triacylglycerol 20:3n9|
1703801|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|-240.8||||0.016||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Triacylglycerol 16:00|
1703802|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|-11.1|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylethanolamine 18:2n6|
1703803|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|-0.2|||<|0.769||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 22:5n6|
1703828|NCT00934596|3133543|Superiority or Other||Median Difference (Net)|57.0|||<|0.01||95.0|||||Wilcoxon (Mann-Whitney)||||
1703829|NCT00934544|3133554|Superiority or Other||Kaplan-Meir estimate|28.1|Standard Deviation|22.123|<|0.0001|2-Sided|95.0|21.3|36.6|||Cochran-Mantel-Haenszel||||
1703805|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|18.3|||<|0.419||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 20:4n6|
1703806|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|-11.8|||<|0.325||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 20:3n6|
1703807|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|-132.1|||<|0.007||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Phosphatidylcholine 18:2n6|
1703808|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|1.1|||<|0.152||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Lysophosphatidylcholine 20:4n6|
1703809|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|-2.5|||<|0.018||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 22:6n3|
1703810|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|0.0|||<|0.776||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 22:5n6|
1703811|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|0.1|||<|0.666||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 20:3n9|
1703812|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|-2.5|||<|0.217||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 20:3n6|
1703813|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|-4.5|||<|0.001||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 18:3n3|
1703814|NCT00935259|3133456|Superiority or Other||Mean Difference (Final Values)|-51.7|||<|0.014||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.||Cholesterol Ester 16:00|
1703815|NCT00935259|3133457|Superiority or Other||Mean Difference (Final Values)|-10.4|Standard Deviation|52.1||0.455||95.0||||Endpoint was analyzed as appropriate for a 2-period crossover model using a mixed model with fixed terms of period and treatment with participants as a random factor.|Mixed Models Analysis|An unstructured covariance and Kenward Roger degrees of freedom were assumed.|||
1703816|NCT00934947|3133472|Superiority|||||||0.48|||||||t-test, 2 sided||||
1703817|NCT00934947|3133473|Superiority|||||||0.32|||||||t-test, 2 sided||||
1703818|NCT00934947|3133474|Superiority|||||||0.36|||||||t-test, 2 sided||||
1703819|NCT00934921|3133476|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|95.9||||||90.0|89.5|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1703820|NCT00934921|3133477|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|95.2||||||90.0|88.8|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1703821|NCT00934921|3133478|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.1||||||90.0|91.2|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1703822|NCT00934843|3133509|Superiority or Other|||||||0.047|||||||ANCOVA|Analysis of variance/covariance models were used to test both unadjusted and multivariable relationships between treatment groups for diuresis.|||
1703823|NCT00934843|3133510|Superiority or Other|||||||0.052||||||Analysis of variance/covariance models were used to test both unadjusted and multivariable relationships between treatment groups for diuresis.|ANCOVA||||
1703824|NCT00934843|3133512|Superiority or Other|||||||0.43||||||A repeated measures analysis of variance framework was used for longitudinal analysis of inotrope score. In order to identify potential confounding variables, a variable was considered a relevant covariate and added into the model with a p ≤ 0.15.|ANCOVA||||
1703825|NCT00934843|3133513|Superiority or Other||Risk Ratio (RR)|0.78||||0.35|2-Sided|95.0|0.45|1.33|||Multivariate risk computation|||The current study was designed with an anticipated enrollment of 87 patients per treatment arm to achieve a statistical power of 80% (1- β) while controlling type I error at 0.05 (α) using a more conservative estimate of LCOS rate in the Single Dose MP group of 33%, and an incidence of LCOS in the Two Dose MP group of 15%.|
1703826|NCT00934596|3133535|Superiority or Other||Median Difference (Net)|17.0|||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)|||As data for these small groups were non-parametric the median and quartiles were used for comparison of groups by the Wilcoxon Rank Sum test.|
1703827|NCT00934596|3133540|Superiority or Other||Median Difference (Net)|72.0|||<|0.001||95.0|||||Wilcoxon (Mann-Whitney)||||
1703830|NCT00934180|3133560|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|101.0||||||90.0|95.2|108.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1703831|NCT00934180|3133561|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|101.0||||||90.0|95.3|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1703832|NCT00934180|3133562|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.0||||||90.0|95.1|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1703833|NCT00933933|3133573|Superiority or Other||Clinical Sensitivity|100.0|||||2-Sided|95.0|94.4|100.0|||||||
1703834|NCT00933933|3133573|Superiority or Other||Clinical Specificity|99.83|||||2-Sided|95.0|99.06|100.0|||||||
1703835|NCT00933933|3133574|Superiority or Other||Clinical Sensitivity|100.0|||||2-Sided|95.0|94.48|100.0|||||||
1703836|NCT00933933|3133574|Superiority or Other||Clinical Specificity|100.0|||||2-Sided|95.0|99.18|100.0|||||||
1703837|NCT00933933|3133575|Superiority or Other||Clinical Sensitivity|100.0|||||2-Sided|95.0|98.18|100.0|||||||
1703838|NCT00933933|3133575|Superiority or Other||Clinical Sensitivity|100.0|||||2-Sided|95.0|99.63|100.0|||||||
1703839|NCT00933933|3133575|Superiority or Other||Clinical Sensitivity|100.0|||||2-Sided|95.0|94.31|100.0|||||||
1703840|NCT00933933|3133576|Superiority or Other||Clinical Specificity|99.77|||||2-Sided|95.0|99.62|99.88|||||||
1703841|NCT00933543|3133607|Superiority or Other||Mean Difference (Net)|0.67||||0.8913|2-Sided|95.0|-9.09|10.43||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model, including center and baseline lesion count as a covariates||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)|
1703842|NCT00933543|3133608|Superiority or Other||Mean Difference (Net)|-3.92||||0.2969|2-Sided|95.0|-11.35|3.5||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model, including center and baseline lesion count as a covariates||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)|
1703843|NCT00933543|3133610|Superiority or Other||Odds Ratio (OR)|6.43||||0.0703|2-Sided|95.0|0.65|63.18||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)|
1703844|NCT00932893|3133743|Superiority or Other||Hazard Ratio (HR)|0.497|||<|0.0001||95.0|0.373|0.661|||Log Rank|||The p-value was obtained from 2-sided unstratified log-rank test. The hazard ratio and corresponding 95% CI from the Cox Proportional Hazards model were also presented.|
1703845|NCT00932893|3133749|Superiority or Other||Risk Ratio (RR)|1.697|||<|0.0001|2-Sided|95.0|1.368|2.103||Statistical significance: 2-sided at alpha=0.0004.|Cochran-Mantel-Haenszel|||P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.|
1703846|NCT00932893|3133750|Superiority or Other||Risk Ratio (RR)|1.502|||<|0.0001||95.0|1.297|1.741||Statistical significance: 2-sided at alpha=0.0004.|Cochran-Mantel-Haenszel|||P-value was obtained from CMH test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.|
1703847|NCT00932893|3133751|Superiority or Other||Risk Ratio (RR)|3.394|||<|0.0001||95.0|2.463|4.676||Statistical significance: 2-sided at alpha=0.025.|Cochran-Mantel-Haenszel|||P-value was obtained from Cochran-Mantel-Haenszel (CMH) test stratified by ECOG PS, brain metastases, and prior EGFR TKI treatment. The risk ratio and corresponding 95% CI from the stratified CMH test were also reported.|
1703848|NCT00932893|3133753|Superiority or Other||Hazard Ratio (HR)|0.854||||0.1145||95.0|0.661|1.104||Statistical significance: 1-sided at alpha=0.025|Log Rank|||P-value was obtained from 1-sided log-rank test stratified by ECOG PS score, brain metastases, and prior EGFR TKI treatment. The hazard ratio and corresponding 95% CI from the stratified Cox proportional hazards model were also presented.|
1703849|NCT00932893|3133754|Superiority or Other||Hazard Ratio (HR)|0.487|||<|0.0001||95.0|0.371|0.638||To control family-wise Type 1 error, a step-down procedure was applied in following order: PFS, objective response rate (ORR), overall survival (OS), and disease control rate (DCR). Statistical significance: 1-sided at alpha=0.025.|Log Rank|||P-value was obtained from 1-sided log-rank test stratified by Eastern Cooperative Oncology Group performance status (ECOG PS) score, brain metastases, and prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) treatment. The hazard ratio and corresponding 95% confidence interval (CI) from the stratified Cox Proportional Hazards model were also presented.|
1703850|NCT00932646|3133777|Superiority or Other||Mean Difference (Final Values)|0.155|Standard Error of the Mean|0.018|<|0.0001||95.0|0.119|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703851|NCT00932646|3133777|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.018|<|0.0001||95.0|0.084|0.157|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703852|NCT00932646|3133777|Superiority or Other||Mean Difference (Final Values)|0.118|Standard Error of the Mean|0.018|<|0.0001||95.0|0.082|0.154|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703853|NCT00932646|3133778|Superiority or Other||Mean Difference (Final Values)|0.148|Standard Error of the Mean|0.055||0.0076||95.0|0.04|0.256|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703854|NCT00932646|3133778|Superiority or Other||Mean Difference (Final Values)|0.139|Standard Error of the Mean|0.055||0.0118||95.0|0.031|0.247|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1704014|NCT00929695|3134148|Superiority or Other||Hazard Ratio (HR)|0.43|||||2-Sided|95.0|0.14|1.33|||||||
1704015|NCT00929695|3134156|Superiority or Other|||||||0.4|||||||t-test, 2 sided||||
1703855|NCT00932646|3133778|Superiority or Other||Mean Difference (Final Values)|0.132|Standard Error of the Mean|0.055||0.0163||95.0|0.024|0.239|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703856|NCT00932646|3133779|Superiority or Other||Mean Difference (Final Values)|0.338|Standard Error of the Mean|0.034|<|0.0001||95.0|0.271|0.405|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703857|NCT00932646|3133779|Superiority or Other||Mean Difference (Final Values)|0.302|Standard Error of the Mean|0.034|<|0.0001||95.0|0.236|0.369|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703858|NCT00932646|3133779|Superiority or Other||Mean Difference (Final Values)|0.299|Standard Error of the Mean|0.034|<|0.0001||95.0|0.233|0.365|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703859|NCT00932646|3133780|Superiority or Other||Mean Difference (Final Values)|0.229|Standard Error of the Mean|0.027|<|0.0001||95.0|0.176|0.281|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703860|NCT00932646|3133780|Superiority or Other||Mean Difference (Final Values)|0.202|Standard Error of the Mean|0.027|<|0.0001||95.0|0.15|0.255|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703861|NCT00932646|3133780|Superiority or Other||Mean Difference (Final Values)|0.206|Standard Error of the Mean|0.026|<|0.0001||95.0|0.155|0.258|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703862|NCT00932646|3133781|Superiority or Other||Mean Difference (Final Values)|0.223|Standard Error of the Mean|0.031|<|0.0001||95.0|0.162|0.284|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703863|NCT00932646|3133781|Superiority or Other||Mean Difference (Final Values)|0.157|Standard Error of the Mean|0.031|<|0.0001||95.0|0.096|0.218|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703864|NCT00932646|3133781|Superiority or Other||Mean Difference (Final Values)|0.161|Standard Error of the Mean|0.031|<|0.0001||95.0|0.101|0.222|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703865|NCT00932646|3133782|Superiority or Other||Mean Difference (Final Values)|0.235|Standard Error of the Mean|0.028|<|0.0001||95.0|0.179|0.291|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703866|NCT00932646|3133782|Superiority or Other||Mean Difference (Final Values)|0.246|Standard Error of the Mean|0.028|<|0.0001||95.0|0.19|0.302|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703867|NCT00932646|3133782|Superiority or Other||Mean Difference (Final Values)|0.251|Standard Error of the Mean|0.028|<|0.0001||95.0|0.195|0.306|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703868|NCT00932646|3133783|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.026||0.0026||95.0|0.028|0.132|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703869|NCT00932646|3133783|Superiority or Other||Mean Difference (Final Values)|0.103|Standard Error of the Mean|0.026||0.0001||95.0|0.051|0.155|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703870|NCT00932646|3133783|Superiority or Other||Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.026||0.0003||95.0|0.045|0.148|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703871|NCT00932646|3133784|Superiority or Other||Mean Difference (Final Values)|0.217|Standard Error of the Mean|0.02|<|0.0001||95.0|0.178|0.255|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703872|NCT00932646|3133784|Superiority or Other||Mean Difference (Final Values)|0.197|Standard Error of the Mean|0.02|<|0.0001||95.0|0.158|0.235|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703873|NCT00932646|3133784|Superiority or Other||Mean Difference (Final Values)|0.192|Standard Error of the Mean|0.019|<|0.0001||95.0|0.154|0.23|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703874|NCT00932646|3133785|Superiority or Other||Mean Difference (Final Values)|0.213|Standard Error of the Mean|0.019|<|0.0001||95.0|0.176|0.25|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703875|NCT00932646|3133785|Superiority or Other||Mean Difference (Final Values)|0.198|Standard Error of the Mean|0.019|<|0.0001||95.0|0.162|0.235|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703876|NCT00932646|3133785|Superiority or Other||Mean Difference (Final Values)|0.186|Standard Error of the Mean|0.019|<|0.0001||95.0|0.149|0.223|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703877|NCT00932646|3133786|Superiority or Other||Mean Difference (Final Values)|0.156|Standard Error of the Mean|0.016|<|0.0001||95.0|0.125|0.187|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1704016|NCT00929695|3134156|Superiority or Other|||||||0.08|||||||t-test, 2 sided||||
1703878|NCT00932646|3133786|Superiority or Other||Mean Difference (Final Values)|0.147|Standard Error of the Mean|0.016|<|0.0001||95.0|0.116|0.179|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703879|NCT00932646|3133786|Superiority or Other||Mean Difference (Final Values)|0.145|Standard Error of the Mean|0.016|<|0.0001||95.0|0.114|0.176|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703880|NCT00932646|3133787|Superiority or Other||Mean Difference (Final Values)|0.158|Standard Error of the Mean|0.017|<|0.0001||95.0|0.124|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703881|NCT00932646|3133787|Superiority or Other||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.017|<|0.0001||95.0|0.14|0.208|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703882|NCT00932646|3133787|Superiority or Other||Mean Difference (Final Values)|0.172|Standard Error of the Mean|0.017|<|0.0001||95.0|0.139|0.205|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703883|NCT00932321|3133835|Non-Inferiority or Equivalence|Primary hypothesis tested was the independence (lack of association) of mean number of IB days in Cycles 2-6 across treatment groups.||||||0.311|||||||Cochran-Mantel-Haenszel|Stratified by investigational site.|||
1703884|NCT00932113|3133872|Other||||||<|0.05|||||||ANOVA||||
1703885|NCT00932035|3133873|Superiority|||||||0.59|||||||Chi-squared||||
1703886|NCT00932035|3133874|Superiority|||||||0.5|||||||Fisher Exact||||
1703887|NCT00932035|3133875|Superiority|To achieve a power of 0.84, a sample size of 72 patients, evenly distributed is required. With 36 patients per group, a Fisher's exact test with a one-sided alpha of 0.05 will have a 84% power to detect the difference between the experimental group (axillary reverse mapping) of 5% or less and a control group (standard dissection) of 30% or more. Response estimates were chosen based on reported lymphedema rates.||||||0.45|||||||Fisher Exact||||
1703888|NCT00931632|3133939|Superiority or Other|||||||0.427|||||||Mantel Haenszel||||
1703889|NCT00931528|3133942|Superiority|||||||0.52|||||||t-test, 2 sided|Significance level = 0.05||Year 2|
1703890|NCT00931528|3133942|Superiority|||||||0.93|||||||t-test, 2 sided|Significance level = 0.05||Year 1|
1703891|NCT00931528|3133942|Superiority|||||||0.86|||||||t-test, 2 sided|Significance level = 0.05||Week 30|
1703892|NCT00931528|3133943|Superiority|||||||0.96|||||||t-test, 2 sided|Significance level = 0.05||Year 2|
1703893|NCT00931528|3133943|Superiority|||||||0.98|||||||t-test, 2 sided|Significance level = 0.05||Year 1|
1703894|NCT00931528|3133943|Superiority|||||||0.67|||||||t-test, 2 sided|Significance level = 0.05||Week 30|
1703895|NCT00931528|3133944|Superiority|||||||0.18|||||||t-test, 2 sided|Significance level = 0.05||Year 2|
1703896|NCT00931528|3133944|Superiority|||||||0.64|||||||t-test, 2 sided|Significance level = 0.05||Year 1|
1703897|NCT00931528|3133944|Superiority|||||||0.14|||||||t-test, 2 sided|Significance level = 0.05||Week 30|
1703898|NCT00931528|3133945|Superiority|||||||0.72|||||||t-test, 2 sided|Significance level = 0.05|||
1703899|NCT00931528|3133945|Superiority|||||||0.65|||||||t-test, 2 sided|Significance level = 0.05||Year 1|
1703900|NCT00931528|3133945|Superiority|||||||0.7|||||||t-test, 2 sided|Significance level = 0.05||Week 30|
1703901|NCT00931528|3133946|Superiority|||||||0.24|||||||t-test, 2 sided|Significance level = 0.05||Year 2|
1703902|NCT00931528|3133946|Superiority|||||||0.99|||||||t-test, 2 sided|Significance level = 0.05||Year 1|
1703903|NCT00931528|3133946|Superiority|||||||0.97|||||||t-test, 2 sided|Significance level = 0.05||Week 30|
1703904|NCT00931528|3133947|Superiority|||||||0.477|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.|
1703905|NCT00931528|3133947|Superiority|||||||0.5237|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.|
1703906|NCT00931528|3133947|Superiority|||||||0.0422|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.|
1703907|NCT00931528|3133947|Superiority|||||||0.5739|||||||Regression, Logistic|||Year 2: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.|
1703908|NCT00931528|3133947|Superiority|||||||0.1855|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [none] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.|
1703909|NCT00931528|3133947|Superiority|||||||0.102|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [none] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. RT method is reported here.|
1703910|NCT00931528|3133947|Superiority|||||||0.9501|||||||Regression, Logistic|||Year 1: Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [none] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, N stage, T stage, PSA.) The results for each explanatory variable are reported separately. Treatment arm is reported here.|
1703911|NCT00931528|3133947|Superiority|||||||0.58|||||||Chi-squared|2-sided significance level = 0.05||Year 2|
1703912|NCT00931528|3133947|Superiority|||||||0.93|||||||Chi-squared|2-sided significance level = 0.05||Year 1|
1703913|NCT00931528|3133948|Superiority|||||||0.0068|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX vs. N0)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. N Stage is reported here.|
1703914|NCT00931528|3133948|Superiority|||||||0.0467|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX vs. N0)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.) The results for each explanatory variable are reported separately. Age is reported here.|
1703915|NCT00931528|3133948|Superiority|||||||0.7908|||||||Regression, Linear|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX vs. N0)] were retained in the model. (Dropped pretreatment characteristics: ethnicity, Zubrod, T stage, PSA.)The results for each explanatory variable are reported separately. RT method is reported here.|
1703916|NCT00931528|3133948|Superiority|||||||0.2386|||||||Regression, Logistic|||Logistic regression using generalized estimating equations was performed modeling the probability of non-responders. Only treatment arm (Placebo vs. Tadalafil), age (> 65 vs. other), RT method (External RT vs. brachytherapy), and significant pretreatment characteristics [N stage (NX vs. N0)] were retained in the model. (Dropped: ethnicity, Zubrod, T stage, prostate-specific antigen (PSA).) The results for each explanatory variable are reported separately. Treatment arm is reported here.|
1703917|NCT00931528|3133948|Superiority or Other||Difference in percentages|5.0||||0.49|2-Sided|95.0|1.0|9.0|||Chi-squared|||Sample size calculations were based on the hypothesis that the use of tadalafil would statistically significant increase the proportion of patients maintaining spontaneous erectile function compared to the use of placebo. Based on a 2-sided Fisher exact test with alpha=0.05, 91 patients/arm would provide 80% statistical power to detect an increase from 20% to 40% in spontaneous erectile response at weeks 28-30. Although designed for the Fisher exact test, Chi-square was used and reported.|
1703918|NCT00931515|3133949|Superiority or Other|||||||1|||||||Fisher Exact||||
1703919|NCT00931385|3133968|Superiority or Other||Mean Difference (Final Values)|0.183|Standard Error of the Mean|0.034|<|0.0001||95.0|0.115|0.25|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703920|NCT00931385|3133968|Superiority or Other||Mean Difference (Final Values)|0.154|Standard Error of the Mean|0.034|<|0.0001||95.0|0.086|0.221|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703921|NCT00931385|3133968|Superiority or Other||Mean Difference (Final Values)|0.154|Standard Error of the Mean|0.034|<|0.0001||95.0|0.087|0.221|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703922|NCT00931385|3133969|Superiority or Other||Mean Difference (Final Values)|0.302|Standard Error of the Mean|0.036|<|0.0001||95.0|0.232|0.372|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703923|NCT00931385|3133969|Superiority or Other||Mean Difference (Final Values)|0.252|Standard Error of the Mean|0.036|<|0.0001||95.0|0.183|0.322|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703924|NCT00931385|3133969|Superiority or Other||Mean Difference (Final Values)|0.261|Standard Error of the Mean|0.035|<|0.0001||95.0|0.191|0.33|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703925|NCT00931385|3133970|Superiority or Other||Mean Difference (Final Values)|0.227|Standard Error of the Mean|0.028|<|0.0001||95.0|0.172|0.282|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703926|NCT00931385|3133970|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.028|<|0.0001||95.0|0.145|0.254|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703927|NCT00931385|3133970|Superiority or Other||Mean Difference (Final Values)|0.186|Standard Error of the Mean|0.028|<|0.0001||95.0|0.132|0.241|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1704017|NCT00929305|3134224|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1704018|NCT00929305|3134227|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1703928|NCT00931385|3133971|Superiority or Other||Mean Difference (Final Values)|0.251|Standard Error of the Mean|0.03|<|0.0001||95.0|0.191|0.311|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703929|NCT00931385|3133971|Superiority or Other||Mean Difference (Final Values)|0.171|Standard Error of the Mean|0.03|<|0.0001||95.0|0.112|0.231|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703930|NCT00931385|3133971|Superiority or Other||Mean Difference (Final Values)|0.147|Standard Error of the Mean|0.03|<|0.0001||95.0|0.087|0.207|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703931|NCT00931385|3133972|Superiority or Other||Mean Difference (Final Values)|0.203|Standard Error of the Mean|0.03|<|0.0001||95.0|0.144|0.262|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703932|NCT00931385|3133972|Superiority or Other||Mean Difference (Final Values)|0.229|Standard Error of the Mean|0.03|<|0.0001||95.0|0.17|0.287|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703933|NCT00931385|3133972|Superiority or Other||Mean Difference (Final Values)|0.226|Standard Error of the Mean|0.03|<|0.0001||95.0|0.167|0.284|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703934|NCT00931385|3133973|Superiority or Other||Mean Difference (Final Values)|0.133|Standard Error of the Mean|0.021|<|0.0001||95.0|0.092|0.175|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703935|NCT00931385|3133973|Superiority or Other||Mean Difference (Final Values)|0.113|Standard Error of the Mean|0.021|<|0.0001||95.0|0.072|0.155|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703936|NCT00931385|3133973|Superiority or Other||Mean Difference (Final Values)|0.106|Standard Error of the Mean|0.021|<|0.0001||95.0|0.064|0.147|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703937|NCT00931385|3133974|Superiority or Other||Mean Difference (Final Values)|0.218|Standard Error of the Mean|0.02|<|0.0001||95.0|0.178|0.257|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703938|NCT00931385|3133974|Superiority or Other||Mean Difference (Final Values)|0.166|Standard Error of the Mean|0.02|<|0.0001||95.0|0.127|0.206|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703939|NCT00931385|3133974|Superiority or Other||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.02|<|0.0001||95.0|0.135|0.214|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703940|NCT00931385|3133975|Superiority or Other||Mean Difference (Final Values)|0.198|Standard Error of the Mean|0.019|<|0.0001||95.0|0.16|0.236|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703941|NCT00931385|3133975|Superiority or Other||Mean Difference (Final Values)|0.164|Standard Error of the Mean|0.019|<|0.0001||95.0|0.127|0.202|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703942|NCT00931385|3133975|Superiority or Other||Mean Difference (Final Values)|0.164|Standard Error of the Mean|0.019|<|0.0001||95.0|0.126|0.201|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703943|NCT00931385|3133976|Superiority or Other||Mean Difference (Final Values)|0.156|Standard Error of the Mean|0.018|<|0.0001||95.0|0.122|0.191|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703944|NCT00931385|3133976|Superiority or Other||Mean Difference (Final Values)|0.137|Standard Error of the Mean|0.017|<|0.0001||95.0|0.103|0.172|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703945|NCT00931385|3133976|Superiority or Other||Mean Difference (Final Values)|0.128|Standard Error of the Mean|0.017|<|0.0001||95.0|0.094|0.163|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703946|NCT00931385|3133977|Superiority or Other||Mean Difference (Final Values)|0.172|Standard Error of the Mean|0.019|<|0.0001||95.0|0.135|0.209|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703947|NCT00931385|3133977|Superiority or Other||Mean Difference (Final Values)|0.127|Standard Error of the Mean|0.019|<|0.0001||95.0|0.091|0.164|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1703948|NCT00931385|3133977|Superiority or Other||Mean Difference (Final Values)|0.109|Standard Error of the Mean|0.019|<|0.0001||95.0|0.073|0.146|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703949|NCT00931385|3133978|Superiority or Other||Mean Difference (Final Values)|0.141|Standard Error of the Mean|0.018|<|0.0001||95.0|0.106|0.177|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Form 12 mcg bid minus Placebo||
1703950|NCT00931385|3133978|Superiority or Other||Mean Difference (Final Values)|0.148|Standard Error of the Mean|0.018|<|0.0001||95.0|0.113|0.183|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 10 mcg qd minus Placebo||
1704615|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.89||||0.8034|2-Sided||||||Cochran-Mantel-Haenszel|||Week 12|
1703951|NCT00931385|3133978|Superiority or Other||Mean Difference (Final Values)|0.148|Standard Error of the Mean|0.018|<|0.0001||95.0|0.113|0.183|||Mixed Models Analysis|Adjusted using a mixed model with center, treatment and period as fixed effects and patients within center as random effect.|Olo 5 mcg qd minus Placebo||
1703952|NCT00931359|3133981|Superiority or Other|||||||0.019|||||||ANOVA||||
1703953|NCT00931359|3133982|Superiority or Other||||||<|0.001|||||||ANOVA|Factors of treatment group and analysis center were considered|||
1703954|NCT00930982|3134025|Superiority or Other||Difference in Least square means|-2.368|Standard Error of the Mean|2.674|<|0.001||||||p-value should be < 0.023 (one-sided) for a significant result as an interim analysis was performed. Results based on the no-interaction model which was defined as primary analysis.|ANCOVA|Baseline cfu was covariate, treatment and pooled centers factors. As the p-value for interaction was 0.214, the no-interaction model is appropriate.|Least square mean Ciprofloxacin minus placebo|"Ho: CFU(EOT|Cipro) - CFU(baseline|Cipro) > CFU(EOT|Placebo) - CFU(baseline|Placebo) CFU = colony forming units EOT=End of treatment (Day 29) Sample size was based a difference of 1.2 log10 CFU/g between placebo and Ciprofloxacin and a standard deviation of 2 log10 CFU/g"|
1703955|NCT00930813|3134047|Superiority or Other|||||||0.016|||||||t-test, 2 sided|||The study required 100 subjects to provide 80% power to detect a clinically meaningful difference in late lumen loss of 15% of reference vessel diameter between treatment groups on the basis of a 2-sample Student t test with 2-sided alpha 0.05.|
1703956|NCT00930774|3134049|Superiority or Other|||||||0.05|||||||ANOVA||||
1703957|NCT00930774|3134049|Superiority or Other|||||||0.013|||||||ANOVA|df = 3,83; F=3.797|||
1703958|NCT00930774|3134050|Superiority or Other||||||<|0.05|||||||ANOVA||||
1703959|NCT00930774|3134050|Superiority or Other||||||<|0.001|||||||ANOVA|df = 3,83. F=6.343|||
1703960|NCT00930774|3134051|Superiority or Other|||||||0.302|||||||ANOVA|df = 3,83; F=1.236|||
1703961|NCT00930774|3134052|Superiority or Other|||||||0.757||||||df = 3,83; F=0.395|ANOVA||||
1703962|NCT00930774|3134053|Superiority or Other|||||||0.554||||||df = 3,83; F=0.701|ANOVA||||
1703963|NCT00930774|3134054|Superiority or Other|||||||0.983|||||||ANOVA|df = 3,83; F=0.054|||
1703964|NCT00930774|3134055|Superiority or Other|||||||0.835|||||||ANOVA|df = 3,83; F=0.286|||
1703965|NCT00930774|3134056|Superiority or Other|||||||0.527|||||||ANOVA|df = 3,83; F=0.748|||
1703966|NCT00930761|3134057|Superiority or Other||Risk Ratio (RR)|1.28||||0.09||95.0|0.95|1.71|||Chi-squared||||
1703967|NCT00930761|3134058|Superiority or Other||Risk Ratio (RR)|1.26||||0.03||95.0|1.01|1.57|||Chi-squared|||Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the first follow-up visit and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.|
1703968|NCT00930761|3134059|Superiority or Other||Risk Ratio (RR)|1.21||||0.13||95.0|0.73|5.66|||Chi-squared||||
1703969|NCT00930761|3134060|Superiority or Other||Risk Ratio (RR)|1.22||||0.06||95.0|0.99|1.51|||Chi-squared|||Null hypothesis: Music therapy does not increase the rate of maternal breastfeeding. Sample size: considering 75% as the expected rate at the time of the infant hospital discharge and an absolute difference of 30% between groups, 95% confidence level (5% alpha error) and 80% power (20% beta error), 94 subjects would need to be enrolled (47 in each study arm). Expecting a 7.5% loss after randomization, 101 was the total number of subjects considered necessary to conduct the study.|
1703970|NCT00930553|3134094|Superiority or Other||Percentage with SRD|13.89|||||2-Sided|95.0|8.47|22.33|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.||
1703971|NCT00930553|3134094|Superiority or Other||Percentage with SRD|16.92|||||2-Sided|95.0|9.75|28.47|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.||
1703972|NCT00930553|3134095|Superiority or Other||Percentage with SRD|42.46|||||2-Sided|95.0|37.08|48.28|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.||
1703973|NCT00930553|3134095|Superiority or Other||Percentage with SRD|32.69|||||2-Sided|95.0|26.96|39.28|||||The percentage and 95% CI of the participants with SRD are estimated by the Kaplan Meier method.||
1703974|NCT00930553|3134096|Superiority or Other||Percentage with SAD|11.99|||||2-Sided|95.0|7.63|18.58|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.||
1703975|NCT00930553|3134096|Superiority or Other||Percentage with SAD|20.42|||||2-Sided|95.0|14.67|28.03|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.||
1703976|NCT00930553|3134096|Superiority or Other||Percentage with SAD|7.95|||||2-Sided|95.0|4.48|13.9|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.||
1703977|NCT00930553|3134096|Superiority or Other||Percentage with SAD|9.35|||||2-Sided|95.0|5.54|15.56|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.||
1703978|NCT00930553|3134097|Superiority or Other||Percentage with SAD|29.69|||||2-Sided|95.0|25.42|34.49|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.||
1703979|NCT00930553|3134097|Superiority or Other||Percentage with SAD|22.33|||||2-Sided|95.0|18.33|27.06|||||The percentage and 95% CI of the participants with SAD are estimated by the Kaplan Meier method.||
1703980|NCT00929994|3134107|Superiority||||||>|0.05||||||A Bonferroni correction for multiple testing was used for post-hoc contrasts|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of MoCA was utilized between the 3 test times (-3, 0 and 6 months). A Bonferroni correction for multiple testing was used for post-hoc contrasts.|
1703981|NCT00929994|3134108|Superiority|||||||0.04||||||A Bonferroni correction for multiple testing was used for post-hoc contrasts.|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance with pairwise comparisons of CES-D was utilized between the 3 test times baseline, 3 and 6 months.|
1703982|NCT00929994|3134109|Superiority|||||||0.01|||||||t-test, 2 sided||||
1703983|NCT00929994|3134110|Superiority|||||||0.06|||||||t-test, 2 sided||||
1704616|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.81||||0.7747|2-Sided||||||Cochran-Mantel-Haenszel|||Week 6|
1703984|NCT00929994|3134110|Other||||||=|0||||||A Bonferroni correction for multiple testing was used for post hoc contrasts. Assumption of sphericity was met for all analyses determined by the Mauchley test of sphericity (all >.05).|ANOVA|||With 1 group and 3 test times, a repeated measures analysis of variance of 6MWD, was utilized between the 3 test times 0, 3, and 6 months). A Bonferroni correction for multiple testing was used for post hoc contrasts.|
1703985|NCT00929864|3134118|Superiority or Other||Difference from adalimumab|-12.2|||||2-Sided|95.0|-16.9|-7.6||||||Analysis for dsDNA at Day 729. Point estimate and 95% CI for treatment difference.|
1703986|NCT00929864|3134118|Superiority or Other||Difference from adalimumab|-9.6|||||2-Sided|95.0|-13.4|-5.7||||||Analysis for dsDNA at Day 365. Point estimate and 95% CI for treatment difference.|
1703987|NCT00929864|3134118|Superiority or Other||Difference from adalimumab|-8.4|||||2-Sided|95.0|-15.3|-1.5||||||Analysis for ANA at Day 729. Point estimate and 95% CI for treatment difference|
1703988|NCT00929864|3134118|Superiority or Other||Difference from adalimumab|-8.1|||||2-Sided|95.0|-13.9|-2.2||||||Analysis for ANA at Day 365. Point estimate and 95% CI for treatment difference.|
1703989|NCT00929864|3134119|Superiority or Other||Difference from adalimumab|-3.1|||||2-Sided|95.0|-7.13|0.92||||||Analysis for incidence rate of discontinuations (all cause) at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.|
1703990|NCT00929864|3134119|Superiority or Other||Difference from adalimumab|-0.52|||||2-Sided|95.0|-1.39|0.36||||||Analysis for incidence rate of opportunistic infections at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.|
1703991|NCT00929864|3134119|Superiority or Other||Difference from adalimumab|-1.24|||||2-Sided|95.0|-3.12|0.63||||||Analysis for incidence rate of Serious infections and infestations Adverse Events at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.|
1703992|NCT00929864|3134119|Superiority or Other||Difference from adalimumab|-1.91|||||2-Sided|95.0|-5.43|1.61||||||Analysis for incidence rate of SAE at 24 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.|
1703993|NCT00929864|3134120|Superiority or Other||Difference from adalimumab|-5.32|||||2-Sided|95.0|-12.06|1.41||||||Analysis for incidence rate of discontinuation for any cause at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.|
1703994|NCT00929864|3134120|Superiority or Other||Difference from adalimumab|0.0|||||2-Sided|95.0|-0.92|0.91||||||Analysis for incidence rate of Opportunistic Infections at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.|
1703995|NCT00929864|3134120|Superiority or Other||Difference from adalimumab|-0.67|||||2-Sided|95.0|-3.27|1.94||||||Analysis for incidence rate of Serious Infections and Infestations at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.|
1703996|NCT00929864|3134120|Superiority or Other||Difference from adalimumab|0.8|||||2-Sided|95.0|-4.51|6.11||||||Analysis for incidence rate of SAE at 12 months. Point estimate and 95% CI for treatment difference. Poisson distribution was used to construct the 95% CIs.|
1703997|NCT00929864|3134121|Superiority or Other||Difference from adalimumab at Day 729|0.9|||||2-Sided|95.0|-5.5|7.3||||||This analysis is for Day 729.|
1703998|NCT00929864|3134121|Superiority or Other||Difference from adalimumab at Day 365|-1.3|||||2-Sided|95.0|-6.5|3.9||||||This analysis is for Day 365.|
1703999|NCT00929864|3134122|Superiority or Other||Difference from adalimumab|-4.13|||||2-Sided|95.0|-6.55|-1.72||||||Analysis of incidence rate at 24 months. Point estimate and 95% CI. Poisson distribution was used to construct the 95% CIs.|
1704000|NCT00929864|3134123|Superiority or Other||Difference in proportions|-5.37||||0.006|2-Sided|95.0|-9.13|-1.62|||Chi-squared|||Analysis is p-value of difference in proportions. n=number of participants with event, N=number of participants at risk. Proportion = n/N. In order to maintain the overall type I error rate of 0.05 for testing both the primary non-inferiority hypothesis and the key secondary local injection site reaction (LISR) hypothesis, the LISR hypothesis was tested at the 5% significance level only after the primary non-inferiority hypothesis is established at the 5% level.|
1704001|NCT00929864|3134124|Non-Inferiority or Equivalence|Analysis tested for non-inferiority. Abatacept will be considered non-inferior to adalimumab if the upper limit of the 95% two-sided CI of difference in ACR20 response rates between the adalimumab arm and the abatacept arm is smaller than or equal to 12%. Estimate and 95% confidence interval (CI) for difference based on minimum risk weights method with randomization stratification of screening Disease Activity Score-28 (DAS28) c-reactive protein (CRP).|Difference from adalimumab at Day 365|1.8|||||2-Sided|95.0|-5.6|9.2||||||The null and alternative hypotheses are H0: T – C<= δ vs. Ha:T - C > δ, where T is the treatment effect of abatacept, C is the effect of active control (adalimumab),and δ is non-inferiority margin. Abatacept is defined as δ non-inferior to adalimumab when H0 is rejected. More specifically, if the lower bound of the 95% two-sided confidence interval for C-T is greater than δ,, then that Abatacept is δ non-inferior to adalimumab can be claimed.|
1704002|NCT00929773|3134126|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1704003|NCT00929773|3134127|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1704004|NCT00929773|3134128|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1704005|NCT00929773|3134129|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1704006|NCT00929773|3134130|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1704007|NCT00929773|3134131|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1704008|NCT00929734|3134132|Superiority or Other|||||||0.028||||||ANCOVA with natural logarithm of interleukin 6 (ln IL6)|ANCOVA||||
1704009|NCT00929734|3134133|Superiority or Other|||||||0.017||||||ANCOVA with natural logarithm of hs-CRP (ln hs-CRP)|ANCOVA||||
1704010|NCT00929734|3134134|Superiority or Other|||||||0.462|||||||ANCOVA||||
1704011|NCT00929734|3134135|Superiority or Other|||||||0.292|||||||ANCOVA||||
1704012|NCT00929695|3134145|Superiority or Other||Hazard Ratio (HR)|1.02||||0.95|2-Sided|95.0|0.6|1.74|||Regression, Cox||||
1704013|NCT00929695|3134147|Superiority or Other||Hazard Ratio (HR)|0.29||||0.009|2-Sided|95.0|0.12|0.74|||Regression, Cox||||
1704019|NCT00929240|3134231|Superiority or Other||Hazard Ratio (HR)|0.425|||<|0.0001|2-Sided|95.0|0.305|0.591||Unstratified analysis|Log Rank||Hazard ratio was determined using the cox regression model.||
1704020|NCT00929240|3134231|Superiority or Other||Hazard Ratio (HR)|0.383|||<|0.0001|2-Sided|95.0|0.266|0.551||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|Log Rank||Stratification variables are randomisation stratification parameters as of IVRS: ER status, Visceral metastasis (yes/no), Response to initial phase, LDH concentration level.||
1704021|NCT00929240|3134234|Superiority or Other||Hazard Ratio (HR)|0.516||||0.002|2-Sided|95.0|0.334|0.798||Unstratified analysis|Log Rank||||
1704022|NCT00929240|3134234|Superiority or Other||Hazard Ratio (HR)|0.425|||<|0.0003|2-Sided|95.0|0.263|0.685||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.|Log Rank||||
1704023|NCT00929240|3134236|Superiority or Other||Mean Difference (Final Values)|1.0||||0.58|2-Sided|95.0|-2.6|4.6|||Chi-squared||CIs with Hauck−Anderson adjustment for difference in rates of Bevacizumab+Capecitabine group to Bevacizumab only group.||
1704024|NCT00929240|3134237|Superiority or Other||Mean Difference (Final Values)|9.1||||0.113|2-Sided|95.0|-2.1|20.3|||Chi-squared||CIs with Hauck-Anderson adjustment for difference in rates of bevacizumab + capecitabine arm to bevacizumab alone arm.||
1704025|NCT00929240|3134238|Superiority or Other||Hazard Ratio (HR)|0.429|||<|0.0001|2-Sided|95.0|0.309|0.597|||Log Rank|Unstratified analysis|||
1704026|NCT00929240|3134238|Superiority or Other||Hazard Ratio (HR)|0.383|||<|0.0001|2-Sided|95.0|0.266|0.551||Stratified by interactive voice/Web response system (IVRS), estrogen receptor (ER) status, visceral metastasis (yes/no), response to initial phase, and lactate dehydrogenase (LDH) level.|Log Rank||Stratified by IVRS, ER status, visceral metastasis (yes/no), response to initial phase, and LDH level.||
1704027|NCT00929201|3134240|Non-Inferiority or Equivalence|The FMI sitagliptin/metformin 50/500 mg FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the Cmax for metformin [i.e., the true metformin Cmax GMR (sitagliptin/metformin 50/500 mg FDC tablet/ co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)].|Least-Squares Mean Ratio|0.95||||||90.0|0.93|0.98||||||Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets|
1704028|NCT00929201|3134241|Non-Inferiority or Equivalence|The FMI sitagliptin/metformin 50/500 mg FDC tablet and coadministration of corresponding doses of sitagliptin and metformin as individual tablets after consumption of a standard high-fat breakfast will be bioequivalent for metformin based on assessment of the AUC0-∞ for metformin [i.e., the true metformin AUC0-∞GMR (sitagliptin/metformin 50/500 mg FDC tablet/co-administration of sitagliptin and metformin as individual tablets will be contained within (0.80, 1.25)].|Least-Squares Mean Ratio|0.97||||||90.0|0.95|1.0||||||Least-Squares Mean Ratio calculated as Sitagliptin/Metformin 50/500 mg FDC tablet divided by Sitagliptin 50 mg and metformin 500 mg individual tablets|
1704029|NCT00928720|3134305|Superiority||Mean Difference (Final Values)|0.05||||0.045|2-Sided||||||Mixed Models Analysis||||
1704030|NCT00928694|3134310|Non-Inferiority or Equivalence|Bioequivalence bounds = (0.80, 1.25) Study Primary Hypothesis: Single 160 mg doses of the U.S. and UK formulations of fenofibrate following consumption of a standard breakfast are bioequivalent (the true GMRs [U.S./UK] for the AUC(0 to infinity) and Cmax of fenofibric acid after administration of the U.S. and UK formulations of fenofibrate with food are contained in the interval [0.80, 1.25]).|Geometric Mean Ratio|0.98||||||90.0|0.9|1.06|||||||
1704031|NCT00928694|3134311|Non-Inferiority or Equivalence|Bioequivalence bounds = (0.80, 1.25) Study Primary Hypothesis: Single 160 mg doses of the U.S. and UK formulations of fenofibrate following consumption of a standard breakfast are bioequivalent (the true geometric mean ratios (GMRs) [U.S./UK] for the AUC(0 to infinity) and maximum plasma concentration (Cmax) of fenofibric acid after administration of the U.S. and UK formulations of fenofibrate with food are contained in the interval [0.80, 1.25]).|Geometric Mean Ratio|0.96||||||90.0|0.9|1.02|||||||
1704032|NCT00928668|3134314|Superiority or Other||Mean Difference (Final Values)|2.645|Standard Error of the Mean|0.27|<|0.0001|2-Sided|95.0|2.11|3.181|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo||
1704033|NCT00928668|3134314|Superiority or Other||Mean Difference (Final Values)|2.114|Standard Error of the Mean|0.27|<|0.0001|2-Sided|95.0|1.578|2.65|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo||
1704034|NCT00928668|3134314|Superiority or Other||Mean Difference (Final Values)|1.825|Standard Error of the Mean|0.274|<|0.0001|2-Sided|95.0|1.281|2.369|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo||
1704035|NCT00928668|3134314|Superiority or Other||Mean Difference (Final Values)|1.229|Standard Error of the Mean|0.271|<|0.0001|2-Sided|95.0|0.692|1.766|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo||
1704036|NCT00928668|3134315|Superiority or Other||Mean Difference (Final Values)|4.22|Standard Error of the Mean|0.294|<|0.0001|2-Sided|95.0|3.637|4.803|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo||
1704037|NCT00928668|3134315|Superiority or Other||Mean Difference (Final Values)|3.327|Standard Error of the Mean|0.29|<|0.0001|2-Sided|95.0|2.752|3.902|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo||
1704038|NCT00928668|3134315|Superiority or Other||Mean Difference (Final Values)|2.474|Standard Error of the Mean|0.299|<|0.0001|2-Sided|95.0|1.822|3.066|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo||
1704039|NCT00928668|3134315|Superiority or Other||Mean Difference (Final Values)|1.907|Standard Error of the Mean|0.295|<|0.0001|2-Sided|95.0|1.322|2.492|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo||
1704040|NCT00928668|3134316|Superiority or Other||Mean Difference (Final Values)|4.208|Standard Error of the Mean|0.296|<|0.0001|2-Sided|95.0|3.622|4.794|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo||
1704041|NCT00928668|3134316|Superiority or Other||Mean Difference (Final Values)|3.549|Standard Error of the Mean|0.292|<|0.0001|2-Sided|95.0|2.971|4.127|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo||
1704042|NCT00928668|3134316|Superiority or Other||Mean Difference (Final Values)|2.38|Standard Error of the Mean|0.3|<|0.0001|2-Sided|95.0|1.785|2.975|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo||
1704043|NCT00928668|3134316|Superiority or Other||Mean Difference (Final Values)|2.025|Standard Error of the Mean|0.296|<|0.0001|2-Sided|95.0|1.437|2.613|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo||
1704044|NCT00928668|3134317|Superiority or Other||Mean Difference (Final Values)|4.224|Standard Error of the Mean|0.249|<|0.0001|2-Sided|95.0|3.731|4.717|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo||
1704045|NCT00928668|3134317|Superiority or Other||Mean Difference (Final Values)|3.56|Standard Error of the Mean|0.245|<|0.0001|2-Sided|95.0|3.074|4.046|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo||
1704046|NCT00928668|3134317|Superiority or Other||Mean Difference (Final Values)|2.636|Standard Error of the Mean|0.252|<|0.0001|2-Sided|95.0|2.135|3.136|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo||
1704047|NCT00928668|3134317|Superiority or Other||Mean Difference (Final Values)|2.139|Standard Error of the Mean|0.249|<|0.0001|2-Sided|95.0|1.645|2.633|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo||
1704048|NCT00928668|3134318|Superiority or Other||Mean Difference (Final Values)|2.984|Standard Error of the Mean|0.251|<|0.0001|2-Sided|95.0|2.486|3.483|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Form 20 mcg minus Placebo||
1704049|NCT00928668|3134318|Superiority or Other||Mean Difference (Final Values)|2.443|Standard Error of the Mean|0.248|<|0.0001|2-Sided|95.0|1.952|2.935|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 10 mcg minus Placebo||
1704050|NCT00928668|3134318|Superiority or Other||Mean Difference (Final Values)|1.711|Standard Error of the Mean|0.255|<|0.0001|2-Sided|95.0|1.205|2.217|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 5 mcg minus Placebo||
1704051|NCT00928668|3134318|Superiority or Other||Mean Difference (Final Values)|1.157|Standard Error of the Mean|0.252|<|0.0001|2-Sided|95.0|0.657|1.657|||Mixed Models Analysis|Adjusted using an analysis of variance with terms for centre, patients within centre, treatment and period (all as fixed effects)|Olo 2 mcg minus Placebo||
1704052|NCT00928434|3134365|Non-Inferiority or Equivalence|Non-inferiority was defined as a lower bound (LCL) of the 95% confidence interval for the difference between the intermittent and pooled continuous treatments, CADT, (intermittent – continuous) of greater than -12.5%.|Percentage difference|1.57|||||2-Sided|95.0|-0.19|3.33|||||||
1704053|NCT00928187|3134420|Superiority or Other|||||||0.13|||||||Chi-squared||||
1704054|NCT00928187|3134421|Superiority or Other|||||||0.26|||||||Chi-squared||||
1704055|NCT00928187|3134422|Superiority or Other|||||||0.001|||||||Chi-squared||||
1704056|NCT00928187|3134427|Non-Inferiority or Equivalence|Hypothesizing 80% efficacy at the 50 copies/mL VL threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.|difference in proportions|6.1|||||2-Sided|95.0|-4.5|16.7|||||||
1704057|NCT00928187|3134427|Non-Inferiority or Equivalence|Hypothesizing 80% efficacy at the 50 copies/mL Viral Load (VL) threshold in the control group at W48, we calculated a required sample size of 150 participants per group to show non-inferiority of ABC/ddI and DRV groups compared with control group in ITT analysis, with a non-inferiority margin of 15%, a power of 90% and a two-sided α of 5%.|differences in proportions|5.6|||||2-Sided|95.0|-5.1|16.4|||||||
1704058|NCT00928070|3134436|Superiority or Other||Median Difference (Final Values)|7.0|||<|0.0001|2-Sided|95.0|3.0|11.0||Statistical testing, two-sided, was done at 5% alpha level.|Van Elteren's test|||Change at Week 12: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.|
1704059|NCT00928070|3134436|Superiority or Other||Median Difference (Final Values)|4.0|||<|0.0021|2-Sided|95.0|0.0|8.0||Statistical testing, two-sided, was done at 5% alpha level.|Van Elteren's test|||Change at Week 4: Van Elteren's test adjusted by baseline PVR quartile was used to calculate p-value. The median difference was based on Hodges-Lehmann estimate.|
1704060|NCT00928070|3134437|Superiority or Other||Least squares mean difference|-0.18|Standard Error of the Mean|0.17||0.2788|2-Sided|95.0|-0.51|0.15||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||ANCOVA model with terms for treatment, center, centered baseline value, and centered baseline by treatment interaction.|
1704061|NCT00928070|3134439|Superiority or Other||||||<|0.0001||||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Not satisfied, neither dissatisfied nor satisfied, satisfied: CMH test with modified ridit scoring controlling for center was used.|
1704062|NCT00928070|3134440|Superiority or Other||Least squares mean difference|16.25|Standard Error of the Mean|2.96|<|0.0001|2-Sided|95.0|10.43|22.08||Statistical testing, two-sided, was done at 5% significance level.|ANOVA|||ANOVA model with treatment and center as factors was used to calculate p-value.|
1708381|NCT00858247|3143272|Superiority or Other|||||||0.8|||||||ANCOVA||||
1704063|NCT00928070|3134441|Superiority or Other||Least squares mean difference|5.53|Standard Error of the Mean|1.88||0.0034|2-Sided|95.0|1.84|9.23||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704064|NCT00928070|3134441|Superiority or Other||Least squares mean difference|2.35|Standard Error of the Mean|1.63||0.1497|2-Sided|95.0|-0.85|5.55||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704065|NCT00928070|3134441|Superiority or Other||Least squares mean difference|4.05|Standard Error of the Mean|2.1||0.0546|2-Sided|95.0|-0.08|8.17||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704066|NCT00928070|3134441|Superiority or Other||Least squares mean difference|5.32|Standard Error of the Mean|2.22||0.0169|2-Sided|95.0|0.96|9.67||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704067|NCT00928070|3134441|Superiority or Other||Least squares mean difference|9.04|Standard Error of the Mean|2.19|<|0.0001|2-Sided|95.0|4.75|13.33||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704068|NCT00928070|3134441|Superiority or Other||Least squares mean difference|5.79|Standard Error of the Mean|1.77|<|0.0012|2-Sided|95.0|2.31|9.28||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704069|NCT00928070|3134441|Superiority or Other||Least squares mean difference|2.46|Standard Error of the Mean|1.53|<|0.1087|2-Sided|95.0|-0.55|5.46||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704070|NCT00928070|3134441|Superiority or Other||Least squares mean difference|4.0|Standard Error of the Mean|2.01|<|0.0472|2-Sided|95.0|0.05|7.95||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704071|NCT00928070|3134441|Superiority or Other||Least squares mean difference|6.96|Standard Error of the Mean|2.13|<|0.0012|2-Sided|95.0|2.77|11.15||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704072|NCT00928070|3134441|Superiority or Other||Least squares mean difference|8.17|Standard Error of the Mean|2.08|<|0.0001|2-Sided|95.0|4.09|12.25||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704073|NCT00928070|3134443|Superiority or Other||Least squares mean difference|-7.6|Standard Error of the Mean|2.03||0.0002|2-Sided|95.0|-11.6|-3.61||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704074|NCT00928070|3134443|Superiority or Other||Least squares mean difference|-9.15|Standard Error of the Mean|1.88|<|0.0001|2-Sided|95.0|-12.85|-5.45||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704075|NCT00928070|3134445|Superiority or Other|||||||0.0021||||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Change at Week 12- deterioration, no change, minor improvement and major improvement: CMH test with modified ridit scoring controlling for center was used to calculate p-value.|
1704076|NCT00928070|3134445|Superiority or Other|||||||0.0009||||||Statistical testing, two-sided, was done at 5% alpha level.|Cochran-Mantel-Haenszel|||Change at Week 4- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for center was used to calculate p-value.|
1704077|NCT00928070|3134446|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.47||0.7437|2-Sided|95.0|-0.78|1.09||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 12: >2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=<2.5/day and >2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.|
1704078|NCT00928070|3134446|Superiority or Other||Mean Difference (Final Values)|-0.41|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.61|-0.21||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 12: =<2.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=<2.5/day and >2.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.|
1704079|NCT00928070|3134446|Superiority or Other||Mean Difference (Final Values)|0.45|Standard Error of the Mean|1.21|<|0.7089|2-Sided|95.0|-2.01|2.92||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 4: >3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=<3.5/day and >3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.|
1704099|NCT00928057|3134463|Superiority or Other||||||<|0.019||||||The threshold for statistical significance, or alpha, is 0.05.|t-test, 1 sided|||The null hypothesis is that the pain from the 4mm is the same or greater than the pain for the reference. The alternative hypothesis is that the pain from the 4mm is less than the pain for the reference.|
1704617|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.67||||0.5381|2-Sided||||||Cochran-Mantel-Haenszel|||Week 6|
1704080|NCT00928070|3134446|Superiority or Other||Mean Difference (Final Values)|-0.34|Standard Error of the Mean|0.11|<|0.0035|2-Sided|95.0|-0.56|-0.11||Statistical testing, two-sided, was done at 5% alpha level.|t-test, 2 sided|||Change at Week 4: =<3.5 undergarments- Protective undergarment usage was analyzed to compare treatments on separate subsets, based on baseline protective undergarment use (=<3.5/day and >3.5/day), using a 2 sample t-test. This method was applied because there was a statistically significant qualitative baseline by treatment interaction.|
1704081|NCT00928070|3134447|Superiority or Other||Least squares mean difference|-4.97|Standard Error of the Mean|1.17|<|0.0001|2-Sided|95.0|-7.27|-2.66||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704082|NCT00928070|3134447|Superiority or Other||Least squares mean difference|-4.67|Standard Error of the Mean|1.21|<|0.0001|2-Sided|95.0|-7.04|-2.3||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704083|NCT00928070|3134449|Superiority or Other|||||||0.001||||||Statistical testing, two-sided, was done at 5% significance level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.|
1704084|NCT00928070|3134450|Superiority or Other||Least squares mean difference|-0.29|Standard Error of the Mean|0.12||0.0189|2-Sided|95.0|-0.53|-0.05||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.|
1704085|NCT00928070|3134450|Superiority or Other||Least squares mean difference|-0.15|Standard Error of the Mean|0.13||0.2511|2-Sided|95.0|-0.39|0.1||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered Baseline value as a covariate was used to calculate p-value.|
1704086|NCT00928070|3134452|Superiority or Other||||||<|0.0001||||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.|
1704087|NCT00928070|3134452|Superiority or Other||||||<|0.0002||||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.|
1704088|NCT00928070|3134453|Superiority or Other||Least squares mean difference|-1.4|Standard Error of the Mean|0.35|<|0.0001|2-Sided|95.0|-2.1|-0.7||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704089|NCT00928070|3134453|Superiority or Other||Least squares mean difference|-1.1|Standard Error of the Mean|0.34|<|0.0014|2-Sided|95.0|-1.77|-0.43||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1704090|NCT00928070|3134455|Superiority or Other||||||<|0.0001||||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.|
1704091|NCT00928070|3134455|Superiority or Other||||||<|0.0001||||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.|
1704092|NCT00928070|3134456|Superiority or Other||Least squares mean difference|-0.84|Standard Error of the Mean|0.23||0.0003|2-Sided|95.0|-1.29|-0.39||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.|
1704093|NCT00928070|3134456|Superiority or Other||Least squares mean difference|-0.87|Standard Error of the Mean|0.24||0.0003|2-Sided|95.0|-1.35|-0.4||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline as a covariate was used to calculate p-value.|
1704094|NCT00928070|3134458|Superiority or Other|||||||0.0001||||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.|
1704095|NCT00928070|3134458|Superiority or Other||||||<|0.0001||||||Statistical testing, two-sided, was done at 5% alpha level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.|
1704096|NCT00928070|3134459|Superiority or Other||Least squares mean difference|-0.82|Standard Error of the Mean|0.23||0.0003|2-Sided|95.0|-1.27|-0.38||Statistical testing, two-sided, was done at 5% significance level.|ANCOVA|||ANCOVA model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.|
1704097|NCT00928070|3134460|Superiority or Other||Least squares mean difference|-0.65|Standard Error of the Mean|0.21||0.0018|2-Sided|95.0|-1.05|-0.24||Statistical testing, two-sided, was done at 5% alpha level.|ANCOVA|||Analysis of covariance (ANCOVA) model with terms for treatment, center, centered baseline, and centered baseline by treatment interaction was used to calculate p-value.|
1704098|NCT00928057|3134463|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||As described for the 4 vs. 5mm statistical analysis.|
1704100|NCT00928057|3134468|Non-Inferiority or Equivalence|"To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.~80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05."||||||0.878||||||The threshold for significance, or alpha, is 0.05.|ANOVA|The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.||"The effects of pen needle type on glycemic control were tested for statistical significance using ANOVA. The ANOVA model was used to calculate the % |∆ Fru|, with 95% confidence intervals."|
1704101|NCT00928057|3134468|Non-Inferiority or Equivalence|"To conclude equivalence for glycemic control, the average absolute percent change in fructosamine and 95% confidence interval had to be within 20%.~80 subjects were required to be in each insulin dose group (40 per PN arm) to provide 90% power for an equivalence with alpha=0.05."||||||0.506||||||The threshold for statistical significance, or alpha, is 0.05.|ANOVA|The ANOVA model has effects for subject, insulin dose group, investigator site and order of pen needle use.||"The effects of pen needle type on glycemic control were tested for statistical significance using analysis of variance (ANOVA). The ANOVA model was used to calculate the absolute percent (%)change in fructosamine (% |∆ Fru|), with 95 % confidence intervals."|
1704102|NCT00927862|3134509|Non-Inferiority or Equivalence|Based on power calculations and feasibility, the minimum recruitment target for the randomized, PG-guided comparison was set at 500 patients. All qualifying parallel control patients were included, anticipated to number ≥1000. For hypothesis 1, the power to exclude inferiority of the modified PG arm vs standard PG arm at a margin (delta) of 5% with 250 patients per group at a 2-sided alpha <0.05 is 87%, assuming a common standard deviation of 0.20.|Mean Difference (Final Values)|0.34|Standard Deviation|0.2|<|0.05|2-Sided|95.0||||Comparisons between groups for primary endpoints were made using the unpaired T-test.|t-test, 2 sided|||Comparisons between groups for primary endpoints were made using the unpaired T-test. All consented, randomized patients who were successfully genotyped and received at least one dose of warfarin with at least one post-dose INR were included in efficacy analyses (modified intention to treat [mITT]).|
1704103|NCT00927576|3134564|Non-Inferiority or Equivalence|Power analysis of controls (i.e., with z-score = 0) showed a 95% chance of detecting a p < 0.05 significance level for z-scores exceeding 0.54 in the mild TBI patient group..|z-score difference between groups|-0.3||||0.5|2-Sided|||||The P-value reflects the likelihood of detection a difference of the magnitude observed.|ANOVA|||The null hypothesis was that the mild TBI group would not differ in age-corrected z-score from that of a control subjects in the large control group.|
1704104|NCT00927576|3134564|Non-Inferiority or Equivalence|Power analysis of the results showed a 95% chance of finding a p<0.05 difference in 166 subjects and a 99% chance of finding a p <0.05 difference in 230 subjects in comparison of Group 1 controls and sTBI patients.|Difference in z-score, sTBI vs. controls|2.04|||<|0.001|2-Sided||||||ANOVA|for repeated measures with effect sizes (omega squared).||The null hypotheses was that the severe TBI group would not differ from the control group in SRT latencies.|
1704105|NCT00927472|3134568|Superiority or Other|||||||0.1527|||||||t-test, 2 sided||||
1704106|NCT00927472|3134569|Superiority or Other|||||||0.1088|||||||t-test, 2 sided||||
1704107|NCT00927472|3134570|Superiority or Other|||||||0.1059|||||||t-test, 2 sided||||
1704108|NCT00927472|3134571|Superiority or Other|||||||0.3817|||||||t-test, 2 sided||||
1704109|NCT00927472|3134572|Superiority or Other|||||||0.0012|||||||t-test, 2 sided||||
1704110|NCT00927472|3134573|Superiority or Other|||||||0.0003|||||||t-test, 2 sided||||
1704111|NCT00927472|3134574|Superiority or Other|||||||0.0002|||||||t-test, 2 sided||||
1704112|NCT00927472|3134575|Superiority or Other|||||||0.049|||||||t-test, 2 sided||||
1704113|NCT00927472|3134576|Superiority or Other|||||||0.3675|||||||t-test, 2 sided||||
1704114|NCT00927472|3134577|Superiority or Other|||||||0.0386|||||||t-test, 2 sided||||
1704115|NCT00927368|3134590|Superiority or Other||incremental cost, measured in dollars|50.0|||||2-Sided||||||||We calculated incremental cost, or the additional cost of stimulating needle + stimulating catheter to ultrasound alone.|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.|
1704116|NCT00927368|3134590|Superiority or Other||incremental cost, measured in dollars|36.0|||||2-Sided||||||||We estimated incremental cost, or additional cost of stimulating needle + catheter stimulation to stimulating needle alone.|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.|
1704117|NCT00927368|3134590|Superiority or Other||incremental cost, measured in dollars|14.0|||||2-Sided||||||||Incremental cost (additional cost of stimulating needle compared to ultrasound alone).|We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.|
1704118|NCT00927368|3134591|Superiority or Other||Mean Difference (Final Values)|67.0|||<|0.001|2-Sided|95.0|31.0|102.0|||ANOVA|||Stimulating catheter versus ultrasound guidance alone|
1704119|NCT00927368|3134591|Superiority or Other||Mean Difference (Final Values)|40.0|||<|0.01|2-Sided|95.0|6.0|75.0|||ANOVA|||Stimulating needle versus ultrasound guidance alone|
1704120|NCT00927368|3134591|Superiority or Other||||||<|0.11|||||||ANOVA|||Stimulating needle versus stimulating catheter.|
1704121|NCT00927368|3134592|Non-Inferiority or Equivalence|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|2.0||||0.02|2-Sided|95.0|-20.0|29.0||Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.|
1704181|NCT00927186|3134632|Superiority or Other|||||||0.002||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704182|NCT00927186|3134632|Superiority or Other|||||||0.979||||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704183|NCT00927186|3134633|Superiority or Other|||||||0.159||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1708382|NCT00858247|3143273|Superiority or Other|||||||0.95|||||||ANCOVA||||
1704122|NCT00927368|3134592|Non-Inferiority or Equivalence|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-2.0||||0.006|2-Sided|95.0|-22.0|25.0||Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating needle to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.|
1704123|NCT00927368|3134592|Non-Inferiority or Equivalence|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-3.0||||0.005|2-Sided|95.0|-24.0|23.0||Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.|
1704124|NCT00927368|3134592|Non-Inferiority or Equivalence|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|3.0||||0.03|2-Sided|95.0|-25.0|21.0||Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating catheter to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.|
1704125|NCT00927368|3134592|Non-Inferiority or Equivalence|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-5.0||||0.002|2-Sided|95.0|-25.0|21.0||Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating needle to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.|
1704126|NCT00927368|3134592|Non-Inferiority or Equivalence|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|5.0||||0.04|2-Sided|95.0|-17.0|34.0||Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for opioid was a linear regression model comparing stimulating catheter to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.|
1704127|NCT00927368|3134593|Non-Inferiority or Equivalence|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|0.28||||0.11|2-Sided|95.0|-0.16|0.72||Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.|
1704128|NCT00927368|3134593|Non-Inferiority or Equivalence|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-0.28|||<|0.001|2-Sided|95.0|-0.72|0.16||Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating needle to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.|
1704129|NCT00927368|3134593|Non-Inferiority or Equivalence|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean catheter is greater than 0.5 points).|Mean Difference (Final Values)|0.12|||<|0.02|2-Sided|95.0|-0.33|0.57||Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.|
1704130|NCT00927368|3134593|Non-Inferiority or Equivalence|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean catheter minus mean ultrasound alone is greater than 0.5 points).|Mean Difference (Final Values)|-0.12|||<|0.001|2-Sided|95.0|-0.57|0.33||Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating catheter to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.|
1704131|NCT00927368|3134593|Non-Inferiority or Equivalence|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).|Mean Difference (Final Values)|0.16|||<|0.03|2-Sided|95.0|-0.29|0.61||Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating catheter to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.|
1704184|NCT00927186|3134633|Superiority or Other|||||||0.906||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704132|NCT00927368|3134593|Non-Inferiority or Equivalence|Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).|Mean Difference (Final Values)|-0.16|||<|0.001|2-Sided|95.0|-0.61|0.29||Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.|t-test, 2 sided|||The primary analysis for pain was a linear regression model comparing stimulating needle to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.|
1704133|NCT00927186|3134603|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1704134|NCT00927186|3134604|Superiority or Other||||||<|0.001||||||P-value is for change from baseline at 6 months.|t-test, 2 sided||||
1704135|NCT00927186|3134604|Superiority or Other||||||<|0.001||||||P-value is for change from baseline at 3 months.|t-test, 2 sided||||
1704136|NCT00927186|3134604|Superiority or Other||||||<|0.001||||||P-value is for change from baseline at 1 month.|t-test, 2 sided||||
1704137|NCT00927186|3134605|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1704138|NCT00927186|3134606|Superiority or Other||||||<|0.001||||||P-value is for change from baseline at 6 months.|t-test, 2 sided||||
1704139|NCT00927186|3134606|Superiority or Other||||||<|0.001||||||P-value is for change from baseline at 3 months.|t-test, 2 sided||||
1704140|NCT00927186|3134606|Superiority or Other||||||<|0.001||||||P-value is for change from baseline at 1 month.|t-test, 2 sided||||
1704141|NCT00927186|3134607|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1704142|NCT00927186|3134608|Superiority or Other||||||<|0.001||||||P-value is for change from baseline at 6 months.|t-test, 2 sided||||
1704143|NCT00927186|3134608|Superiority or Other||||||<|0.001||||||P-value is for change from baseline at 3 months.|t-test, 2 sided||||
1704144|NCT00927186|3134608|Superiority or Other||||||<|0.001||||||P-value is for change from baseline at 1 month.|t-test, 2 sided||||
1704145|NCT00927186|3134609|Superiority or Other|||||||0.092||||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)||||
1704146|NCT00927186|3134609|Superiority or Other|||||||0.012||||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)||||
1704147|NCT00927186|3134610|Superiority or Other|||||||0.025|||||||Wilcoxon (Mann-Whitney)||||
1704148|NCT00927186|3134611|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1704149|NCT00927186|3134612|Superiority or Other|||||||0.268||||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)||||
1704150|NCT00927186|3134612|Superiority or Other|||||||0.027||||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)||||
1704151|NCT00927186|3134613|Superiority or Other|||||||0.079|||||||Wilcoxon (Mann-Whitney)||||
1704152|NCT00927186|3134614|Superiority or Other|||||||0.014|||||||Wilcoxon (Mann-Whitney)||||
1704153|NCT00927186|3134615|Superiority or Other|||||||0.039||||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)||||
1704154|NCT00927186|3134615|Superiority or Other||||||<|0.001||||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)||||
1704155|NCT00927186|3134616|Superiority or Other|||||||0.079|||||||Wilcoxon (Mann-Whitney)||||
1704156|NCT00927186|3134617|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1704157|NCT00927186|3134618|Superiority or Other|||||||0.006||||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)||||
1704158|NCT00927186|3134618|Superiority or Other||||||<|0.001||||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)||||
1704159|NCT00927186|3134619|Superiority or Other|||||||0.008|||||||Wilcoxon (Mann-Whitney)||||
1704160|NCT00927186|3134620|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1704161|NCT00927186|3134621|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1704162|NCT00927186|3134622|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1704163|NCT00927186|3134623|Superiority or Other|||||||0.896||||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)||||
1704164|NCT00927186|3134623|Superiority or Other|||||||0.536||||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)||||
1704165|NCT00927186|3134624|Superiority or Other|||||||0.906|||||||Wilcoxon (Mann-Whitney)||||
1704166|NCT00927186|3134625|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1704167|NCT00927186|3134626|Superiority or Other|||||||0.009||||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label at 24 months."|Fisher Exact||||
1704168|NCT00927186|3134626|Superiority or Other||||||<|0.001||||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label at 6 months."|Fisher Exact||||
1704169|NCT00927186|3134627|Superiority or Other|||||||0.033||||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label."|Fisher Exact||||
1704170|NCT00927186|3134628|Superiority or Other||||||<|0.001||||||"P-value is a comparison of No Label vs. Single, Double, Single and Double Label."|Fisher Exact||||
1704171|NCT00927186|3134629|Superiority or Other|||||||0.006||||||P-value is for dLS/BS at 24 months.|Wilcoxon (Mann-Whitney)||||
1704172|NCT00927186|3134629|Superiority or Other|||||||0.004||||||P-value is for sLS/BS at 24 months.|Wilcoxon (Mann-Whitney)||||
1704173|NCT00927186|3134629|Superiority or Other||||||<|0.001||||||P-value is for dLS/BS at 6 months.|Wilcoxon (Mann-Whitney)||||
1704174|NCT00927186|3134629|Superiority or Other||||||<|0.001||||||P-value is for sLS/BS at 6 months.|Wilcoxon (Mann-Whitney)||||
1704175|NCT00927186|3134630|Superiority or Other|||||||0.001||||||P-value is for dLS/BS.|Wilcoxon (Mann-Whitney)||||
1704176|NCT00927186|3134630|Superiority or Other|||||||0.006||||||P-value is for sLS/BS.|Wilcoxon (Mann-Whitney)||||
1704177|NCT00927186|3134631|Superiority or Other||||||<|0.001||||||P-value is for dLS/BS.|Wilcoxon (Mann-Whitney)||||
1704178|NCT00927186|3134631|Superiority or Other||||||<|0.001||||||P-value is for sLS/BS.|Wilcoxon (Mann-Whitney)||||
1704179|NCT00927186|3134632|Superiority or Other|||||||0.853||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704180|NCT00927186|3134632|Superiority or Other|||||||0.695||||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704185|NCT00927186|3134634|Superiority or Other|||||||0.052||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704186|NCT00927186|3134634|Superiority or Other|||||||0.154||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704187|NCT00927186|3134635|Superiority or Other|||||||0.139||||||-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704188|NCT00927186|3134635|Superiority or Other|||||||0.151||||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704189|NCT00927186|3134635|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704190|NCT00927186|3134635|Superiority or Other||||||<|0.022||||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704191|NCT00927186|3134636|Superiority or Other|||||||0.198||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704192|NCT00927186|3134636|Superiority or Other|||||||1||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704193|NCT00927186|3134637|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704194|NCT00927186|3134637|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704195|NCT00927186|3134638|Superiority or Other|||||||1||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704196|NCT00927186|3134638|Superiority or Other|||||||0.695||||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704197|NCT00927186|3134638|Superiority or Other|||||||0.12||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704198|NCT00927186|3134638|Superiority or Other|||||||0.647||||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704199|NCT00927186|3134639|Superiority or Other|||||||0.358||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704200|NCT00927186|3134639|Superiority or Other|||||||0.077||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704201|NCT00927186|3134640|Superiority or Other|||||||0.597||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704202|NCT00927186|3134640|Superiority or Other|||||||0.502||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704203|NCT00927186|3134641|Superiority or Other|||||||0.196||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704204|NCT00927186|3134641|Superiority or Other|||||||0.151||||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704205|NCT00927186|3134641|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704206|NCT00927186|3134641|Superiority or Other||||||<|0.049||||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704207|NCT00927186|3134642|Superiority or Other|||||||0.159||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704208|NCT00927186|3134642|Superiority or Other|||||||0.906||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704209|NCT00927186|3134643|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704210|NCT00927186|3134643|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704211|NCT00927186|3134644|Superiority or Other|||||||0.003||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704212|NCT00927186|3134644|Superiority or Other|||||||0.003||||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704213|NCT00927186|3134644|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704214|NCT00927186|3134644|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704215|NCT00927186|3134645|Superiority or Other|||||||0.016||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704216|NCT00927186|3134645|Superiority or Other|||||||0.05||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704217|NCT00927186|3134646|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704218|NCT00927186|3134646|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704219|NCT00927186|3134647|Superiority or Other|||||||0.025||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704220|NCT00927186|3134647|Superiority or Other|||||||0.039||||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704221|NCT00927186|3134647|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704222|NCT00927186|3134647|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704223|NCT00927186|3134648|Superiority or Other|||||||0.005||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704224|NCT00927186|3134648|Superiority or Other|||||||0.02||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704225|NCT00927186|3134649|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704226|NCT00927186|3134649|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704227|NCT00927186|3134650|Superiority or Other|||||||0.002||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704228|NCT00927186|3134650|Superiority or Other|||||||0.003||||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704229|NCT00927186|3134650|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704230|NCT00927186|3134650|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704231|NCT00927186|3134651|Superiority or Other|||||||0.002||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704232|NCT00927186|3134651|Superiority or Other|||||||0.002||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704233|NCT00927186|3134652|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704234|NCT00927186|3134652|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704235|NCT00927186|3134653|Superiority or Other|||||||0.002||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704236|NCT00927186|3134653|Superiority or Other|||||||0.002||||||P-value is for double labels (DL) and no labels (NL) at 24 months.|Wilcoxon (Mann-Whitney)||||
1704237|NCT00927186|3134653|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704238|NCT00927186|3134653|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL) and no labels (NL) at 6 months.|Wilcoxon (Mann-Whitney)||||
1704239|NCT00927186|3134654|Superiority or Other|||||||0.002||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704240|NCT00927186|3134654|Superiority or Other|||||||0.002||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704241|NCT00927186|3134655|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL), imputed single labels (ISL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704242|NCT00927186|3134655|Superiority or Other||||||<|0.001||||||P-value is for double labels (DL) and no labels (NL).|Wilcoxon (Mann-Whitney)||||
1704243|NCT00927186|3134656|Superiority or Other|||||||0.002||||||P-value is for 24 months.|Wilcoxon (Mann-Whitney)||||
1704244|NCT00927186|3134656|Superiority or Other||||||<|0.001||||||P-value is for 6 months.|Wilcoxon (Mann-Whitney)||||
1704245|NCT00927186|3134657|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1704246|NCT00927186|3134658|Superiority or Other||||||<|0.001||||||The pre-specified significance level 0.05 was used.|Wilcoxon (Mann-Whitney)||||
1704247|NCT00926887|3134690|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|df=102, t=-3.44|||
1704248|NCT00926887|3134694|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|t=-2.711; df=102; p<0.01|||
1704249|NCT00926887|3134697|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1704250|NCT00926848|3134698|Superiority||Mean Difference (Final Values)|0.8|||>|0.05|2-Sided||||||t-test, 2 sided||||
1704251|NCT00926848|3134699|Superiority||Mean Difference (Final Values)|0.3|||>|0.05|2-Sided||||||t-test, 2 sided||||
1704252|NCT00926848|3134700|Superiority||Mean Difference (Final Values)|0.6|||>|0.05|2-Sided||||||t-test, 2 sided||||
1704253|NCT00926848|3134701|Superiority||Mean Difference (Final Values)|0.3|||>|0.05|2-Sided||||||t-test, 2 sided||||
1704254|NCT00926848|3134702|Superiority||Mean Difference (Final Values)|6.6|||>|0.05|2-Sided||||||t-test, 2 sided||||
1704255|NCT00926848|3134703|Superiority||Mean Difference (Final Values)|4.0|||>|0.05|2-Sided||||||t-test, 2 sided||||
1704256|NCT00926796|3134705|Superiority or Other||Proportion of cured participants|99.5|||<|0.05|1-Sided|95.0|97.64||||Exact bionomial confidence limit|If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is <95% is rejected.|When the lower 95% confidence interval is above 95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly >=95%).|The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is <95%.|
1704257|NCT00926796|3134712|Superiority or Other||Proportion of cured participants|100.0|||<|0.05|1-Sided|95.0|98.53||||Exact binomial confidence limit|If the one-sided lower 95% confidence limit is greater than 95%, the null hypothesis of the microbiological efficacy estimate is <95% is rejected.|When the lower 95% confidence limit is >=95%, the alternative hypothesis is accepted (i.e., the microbiological cure estimate is significantly >=95%).|The null hypothesis is that the microbiological efficacy estimate (proportion of participants who are cured) is <95%.|
1704258|NCT00926783|3134717|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||The null hypothesis is that the total RF delivery times for both arms are equal. The alternative hypothesis is that the total RF delivery times are not equal. Due to the lack of literature data comparing these endpoints between two randomization groups, the sample size is not statistically powered to support statistical inferences.|
1704259|NCT00926783|3134718|Superiority or Other|||||||0.048||||||The p-value was based on Fisher's exact test. There were no adjustments for multiple comparisons.|Fisher Exact|||The null hypothesis is that rates of free from atrial arrhythmia for the two arms, Targeted and Generalized, are the same. The alternative hypothesis is that the rates are not the same. Due to the lack of literature data comparing these endpoints between two randomization groups, the sample size is not statistically powered to support statistical inferences.|
1704260|NCT00926536|3134723|Superiority or Other||Mean Difference (Net)|158.3||||0.017|2-Sided|||||Decrease in CD in C-arm CT +DSA group when compared to DSA only|Mixed Models Analysis||||
1704449|NCT00923260|3135220|Superiority or Other|||||||0.49|||||||t-test, 2 sided||||
1704261|NCT00926536|3134724|Superiority or Other||Mean Difference (Net)|71.6|||<|0.001|2-Sided|||||Decrease in DAP in C-arm CT +DSA group when compared to DSA only|Mixed Models Analysis||||
1704262|NCT00926497|3134725|Superiority or Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)||||
1704263|NCT00926497|3134725|Superiority or Other|||||||0.012|||||||t-test, 2 sided||||
1704264|NCT00926497|3134726|Superiority or Other|||||||0.002|||||||Fisher Exact|||The trial was designed to obtain a power of 90% to detect a 30% difference between the two groups in the duration of antibiotic therapy with an estimated standard deviation of 50%.|
1704265|NCT00926367|3134756|Superiority or Other||||||>|0.05||||||A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.|Dunn's Multiple Comparisons Test||||
1704266|NCT00926367|3134758|Superiority or Other||||||>|0.05|||||||Dunn's Multiple Comparisons Test|A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.|||
1704267|NCT00926328|3134759|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1704268|NCT00926328|3134760|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1704269|NCT00926289|3134761|Superiority or Other||||||<|0.0001|||||||Van Elteren test stratified for country|||T80+HCTZ25 versus T80 monotherapy|
1704270|NCT00926289|3134762|Superiority or Other||Odds Ratio (OR)|2.23|||<|0.0001||95.0|1.57|3.16|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy|
1704271|NCT00926289|3134763|Superiority or Other||Odds Ratio (OR)|2.62|||<|0.0001||95.0|1.7|4.04|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy|
1704272|NCT00926289|3134764|Superiority or Other||Odds Ratio (OR)|2.42|||<|0.0001||95.0|1.78|3.29|||Regression, Logistic|Adjustment for continuous covariate of baseline (DBP), treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy|
1704273|NCT00926289|3134765|Superiority or Other||Odds Ratio (OR)|2.39|||<|0.0001||95.0|1.76|3.26|||Regression, Logistic|Adjustment for continuous covariate of baseline (SBP), treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy|
1704274|NCT00926289|3134766|Superiority or Other||Odds Ratio (OR)|1.74||||0.0005||95.0|1.28|2.37|||Regression, Logistic|Adjustment for continuous covariate of baseline and fixed effect country||T80+HCTZ25 versus T80 monotherapy|
1704275|NCT00926289|3134767|Superiority or Other||Odds Ratio (OR)|2.02|||<|0.0001||95.0|1.48|2.76|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy|
1704276|NCT00926289|3134768|Superiority or Other||Odds Ratio (OR)|2.0|||<|0.0001||95.0|1.46|2.73|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy|
1704277|NCT00926289|3134769|Superiority or Other||Odds Ratio (OR)|2.19|||<|0.0001||95.0|1.6|3.01|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy|
1704278|NCT00926289|3134770|Superiority or Other||Odds Ratio (OR)|2.3|||<|0.0001||95.0|1.7|3.12|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy|
1704279|NCT00926289|3134771|Superiority or Other||Odds Ratio (OR)|2.36|||<|0.0001||95.0|1.74|3.21|||Regression, Logistic|Adjustment for continuous covariate of baseline, treatment and country as fixed effects.||T80+HCTZ25 versus T80 monotherapy|
1704280|NCT00926289|3134772|Superiority or Other||Mean Difference (Final Values)|-3.2|||<|0.0001||95.0|-4.5|-1.9|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy|
1704281|NCT00926289|3134773|Superiority or Other||Mean Difference (Final Values)|-6.8|||<|0.0001||95.0|-8.8|-4.7|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy|
1704282|NCT00926289|3134774|Superiority or Other||Mean Difference (Final Values)|-7.3|||<|0.0001||95.0|-9.3|-5.2|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy|
1704283|NCT00926289|3134775|Superiority or Other||Mean Difference (Final Values)|-8.5|||<|0.0001||95.0|-10.6|-6.4|||ANCOVA|Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction||T80+HCTZ25 versus T80 monotherapy|
1704284|NCT00926211|3134790|Non-Inferiority or Equivalence|Study was powered for the primary efficacy outcome.|Mean Difference (Final Values)|0.045|Standard Deviation|0.146|<|0.001|1-Sided|97.5|-0.004||||t-test, 1 sided|Paired t-test.||Paired data with each subject as their own control (treatment was randomly assigned to the left or right side of the scalp). Paired difference was analyzed.|
1704285|NCT00926211|3134791|Non-Inferiority or Equivalence|Initial planned sample size of 26 would provide approximately 90% power if the survival rate in the implanted transected follicles is at least 40%. Sample size used was 36 with 35 participants completing the 9 month study.|Mean Difference (Net)|-1.4|Standard Deviation|15.5||0.023|1-Sided|97.5||3.9||t-test comparison to the upper limit of the non-inferiority margin|t-test, 1 sided|Paired t-test compared to the non-inferiority margin of 4 follicles.|The number of implanted hairs surviving that were harvested using the computer assisted method was subtracted from the number of implanted hairs surviving that were harvested manually.|The hypothesis to be tested is one of non-inferiority. Tests of non-inferiority are one-sided tests and the significance level will be 0.025.|
1704286|NCT00926185|3134793|Superiority or Other||Treatment Effect|0.27||||0.1375|2-Sided|95.0|-0.06|0.6|||Dunnett’s test||Analysis of covariance model with treatment, baseline, and site.||
1704287|NCT00926185|3134793|Superiority or Other||Treatment Effect|0.2||||0.3585|2-Sided|95.0|-0.13|0.53|||Dunnett’s test||Analysis of covariance model with treatment, baseline, and site.||
1704288|NCT00926185|3134793|Superiority or Other||Treatment Effect|0.06||||0.9381|2-Sided|95.0|-0.26|0.39|||Dunnett’s test||Analysis of covariance model with treatment, baseline, and site.||
1704450|NCT00923260|3135221|Superiority or Other|||||||0.79|||||||t-test, 2 sided||||
1704289|NCT00926029|3134794|Superiority or Other|||||||0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1704290|NCT00926029|3134795|Superiority or Other|||||||0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1704291|NCT00926003|3134796|Superiority|||||||0.18|||||||ANCOVA|||Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ARV at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline|
1704292|NCT00926003|3134797|Superiority|||||||0.02|||||||ANCOVA|||Least Square Means from Longitudinal Model, Their Standard Errors by Trial Arm Adjusted for Age, Being on ART at Intake, Socioeconomic Score, Home Score, Recruitment Location, KABC Learning and Delayed Recall Scores at Baseline, and Outcome Score at Baseline|
1704293|NCT00925704|3134830|Superiority or Other|||||||0.305|||||||Wilcoxon (Hodges-Lehmann)|||Analysis for Tmax used the Hodges-Lehmann estimate for Wilcoxon's Signed Rank Test.|
1704294|NCT00925704|3134830|Superiority or Other|||||||0.039|||||||Wilcoxon (Hodges-Lehmann)|||Analysis for Tmax used the Hodges-Lehmann estimate for Wilcoxon's Signed Rank Test.|
1704295|NCT00925704|3134831|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.|
1704296|NCT00925704|3134831|Superiority or Other||||||<|0.313|||||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.|
1704297|NCT00925704|3134832|Superiority or Other|||||||0.024|||||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.|
1704298|NCT00925704|3134832|Superiority or Other|||||||0.171|||||||Mixed Models Analysis|||Exogenous calcitriol was analyzed using a mixed linear effects model. This model contained sequence group, period, and treatment as fixed effects. The subject within sequence effect was included as a random effect.|
1704299|NCT00925600|3134836|Superiority or Other||Risk Difference (RD)|-2.2|Standard Error of the Mean|2.8|||2-Sided|95.0|-7.6|3.3||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (< 3.0 at all sites [P, C, and NO] vs. ≥ 3.0 at any of these sites), age group (< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).|
1704300|NCT00925600|3134837|Superiority or Other||Risk Difference (RD)|-0.3|Standard Error of the Mean|2.9|||2-Sided|95.0|-5.9|5.3||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (< 3.0 at all sites [P, C, and NO] vs. ≥ 3.0 at any of these sites), age group (< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).|
1704301|NCT00925600|3134838|Superiority or Other||Risk Difference (RD)|-2.2|Standard Error of the Mean|2.1|||2-Sided|95.0|-6.4|2.0||||||The point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval was constructed using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (< 3.0 at all sites [P, C, and NO] vs. ≥ 3.0 at any of these sites), age group (< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).|
1704302|NCT00925600|3134839|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the upper bound of the 97.5% one-sided confidence interval, or equivalently upper bound of two-sided 95% confidence interval was less than the pre-specified non-inferiority bound of 10%.|Risk Difference (RD)|0.4|Standard Error of the Mean|3.4||0.0026|2-Sided|95.0|-6.3|7.2|||Mantel Haenszel|||The primary endpoint was summarized with the point estimate of absolute risk difference (difference in incidence rates, denosumab minus placebo) and the corresponding 95% confidence interval using the Mantel-Haenszel method adjusting for the stratification factors: baseline LOCS III status (< 3.0 at all sites [P, C, and NO] vs. ≥ 3.0 at any of these sites), age group (< 75, ≥ 75 years), and patient-reported history of cataract (yes/no).|
1704303|NCT00925587|3134893|Non-Inferiority or Equivalence|Non-inferiority margin -0.5 g/dL|Mean Difference (Final Values)|-0.188|Standard Error of the Mean|0.122|||2-Sided|95.0|-0.427|0.052|||||Darbepoetin alfa QM - Darbepoetin alfa Q2W|Power = 90% at sample size calculation|
1704304|NCT00925353|3134909|Superiority or Other||Actual lab results shown|1.0|||<|0.05||95.0|||||non-compartmental pharmacokinetic|The planned analysis was to estimate pharmacokinetic parameters. There were too few detectable values to be able to perform this analysis.||Null Hypothesis: Application of 4% lidocaine gel on the breasts and chest wall of healthy women occluded for one hour does not result in systemically toxic plasma concentrations of lidocaine or its principal metabolite, monoethylglycinexyliidie (MEGX), electrocardiogram changes, or adverse events.|
1704305|NCT00925301|3134910|Other||Difference LSMeans|-0.3||||0.0078|2-Sided|95.0|-0.6|-0.1||Significant at the 0.010 level|ANCOVA|||The change from Baseline in the average number of kidney ICs was analyzed using an ANCOVA model with covariate adjustment for the baseline value and factors for treatment group and the treatment by baseline interaction.|
1704306|NCT00925301|3134911|Other|Mixed effects model for repeated measures (MMRM) approach with fixed effects of treatment, time (Month 6 and Month 12), mutation type (amenable or non-amenable), time by treatment interaction, time by mutation type interaction, and the baseline value as a covariate. An unstructured covariance matrix to account for repeated measures within a participant was assumed.||||||0.014||||||Significant at the 0.050 level|MMRM||||
1704307|NCT00925301|3134914|Superiority||Difference|12.5||||0.2996|2-Sided|95.0|-13.4|37.3|||Cochran-Mantel-Haenszel|p-value from Cochran-Mantel-Haenszel test stratified by sex|The difference between the percentage of successes between migalastat and placebo treatment groups||
1704308|NCT00925288|3134916|Superiority or Other|||||||0.53|||||||Chi-squared|||comparison of differences in HPV DNA prevalence by study arm.|
1704309|NCT00925288|3134917|Superiority or Other|||||||0.6|||||||Chi-squared|||Completion rates compared in the 2 study arms|
1704618|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.82||||0.7582|2-Sided||||||Cochran-Mantel-Haenszel|||Week 6|
1704310|NCT00925288|3134918|Non-Inferiority or Equivalence|Since the standard schedule is at (0, 2, 6 months), and the modified schedule at (0, 3, 6 months), we will consider this a non-inferiority study. With 80% power, type 1 error of 0.05, standard deviations of 0.6, and an equivalence margin of 0.3, 64 women are needed per group to detect non-inferiority. Having 100 women in each study arm will yield over 94% power to detect non-inferiority of the modified schedule.|||||>|0.2|||||||Regression, Logistic|||The null hypothesis is that both schedules will provide an equivalent antibody response.|
1704311|NCT00924950|3134964|Superiority||Mean Difference (Final Values)|0.8571||||0.0008|2-Sided||||||t-test, 2 sided||||
1704312|NCT00924833|3134974|Superiority or Other||||||<|0.05||||||ANOVA with unpaired Student‘s t–test, Bonferroni correction. Bonferroni correction. p = 0.05.|ANOVA|||No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects.|
1704313|NCT00924833|3134977|Superiority or Other|||||||0.93||||||Within subjects effects. Time: p = 0.03. Time * treatment: p = 0.12.|ANOVA|||"Differences among groups, changes over time and interactions: two-way repeated measures ANOVA with unpaired Student‘s t–test, Bonferroni correction.~No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects."|
1704314|NCT00924833|3134978|Superiority or Other||||||<|0.05||||||P < 0.05. Bonferroni correction: p < 0.05 nebivolol versus carvedilol|ANOVA|||No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects.|
1704315|NCT00924833|3134979|Superiority or Other|||||||0.01||||||"Within subjects effects. Time: P < 0.01. Time * treatment: P=0.25~Bonferroni correction. Within the placebo, carvedilol and nebivolol group, p < 0.01 for Time 3 - Time 1, and Time 3 - Time 2."|ANOVA|||"Differences among groups, changes over time and interactions: two-way repeated measures ANOVA with unpaired Student‘s t–test, Bonferroni correction.~No previous studies have compared carvedilol, nebivolol, and placebo with respecto to exercise performance in hypobaric hypoxia. The sample size set for each treatment arm was defined on the basis of the sample size of previous investigations showing significant changes in exercise performance in normal subjects."|
1704316|NCT00924729|3134990|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1704317|NCT00924651|3134991|Other||Mean Difference (Final Values)|-0.01916|Standard Error of the Mean|0.1791||0.9148|2-Sided|95.0|-0.371|0.3327|||ANCOVA||||
1704318|NCT00924638|3134993|Superiority or Other||Hazard Ratio (HR)|1.37||||0.33|2-Sided|95.0|0.73|2.6|||Log Rank||A hazard ratio of < 1 indicates that the incidence rate of cardiovascular or stroke/TIA related hospitalization is lower in the Continuous Monitoring arm compared to the Control arm.||
1704319|NCT00924638|3134994|Superiority or Other|||||||0.11|||||||t-test, 2 sided||||
1704320|NCT00924638|3134995|Superiority or Other||Mean Difference (Final Values)|0.4|||||2-Sided|95.0|-2.3|3.1|||||A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the anti-arrhythmic drugs at the 12 months visit compared to the Control arm.||
1704321|NCT00924638|3134996|Superiority or Other||Mean Difference (Final Values)|8.8|||||2-Sided|95.0|2.8|14.8|||||A difference of greater than 0 means that a higher percentage of subjects in the Continuous Monitoring arm were using the OAC drugs at the 12 months visit compared to the Control arm.||
1704322|NCT00924638|3134997|Superiority or Other||Hazard Ratio (HR)|0.68||||0.25|2-Sided|95.0|0.35|1.32|||Log Rank||A hazard ratio of < 1 indicates that the incidence rate of recurrent stroke or TIA is lower in the Continuous Monitoring arm compared to the Control arm.||
1704323|NCT00924638|3134998|Superiority or Other||Hazard Ratio (HR)|7.3|||<|0.0001|2-Sided|95.0|2.6|20.8|||Log Rank||A hazard ratio of > 1 indicates that Continuous Monitoring is superior to Control in detecting AF.||
1704324|NCT00924638|3134999|Superiority or Other||Hazard Ratio (HR)|6.4||||0.0006|2-Sided|95.0|1.9|21.7|||Log Rank||A hazard ratio of > 1 indicates that Continuous Monitoring is superior to Control in detecting AF.||
1704325|NCT00924560|3135006|Superiority or Other||LS Mean Difference|-21.17|||||2-Sided|95.0|-44.08|1.74||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704326|NCT00924560|3135006|Superiority or Other||LS Mean Difference|-12.09|||||2-Sided|95.0|-34.99|10.81||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704327|NCT00924560|3135006|Superiority or Other||LS Mean Difference|-7.55|||||2-Sided|95.0|-25.65|10.55||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704328|NCT00924560|3135006|Superiority or Other||LS Mean Difference|-5.48|||||2-Sided|95.0|-23.57|12.61||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704329|NCT00924560|3135007|Superiority or Other||LS Mean Difference|0.0|||||2-Sided|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704330|NCT00924560|3135007|Superiority or Other||LS Mean Difference|0.0|||||2-Sided|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704331|NCT00924560|3135007|Superiority or Other||LS Mean Difference|0.0|||||2-Sided|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704332|NCT00924560|3135007|Superiority or Other||LS Mean Difference|0.0|||||2-Sided|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704510|NCT00922272|3135394|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.4364|2-Sided|95.0|-4.8|2.1|||ANCOVA|||Metacognition Index|
1704333|NCT00924560|3135008|Superiority or Other||LS Mean Difference|-0.14|||||2-Sided|95.0|-0.32|0.03||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704334|NCT00924560|3135008|Superiority or Other||LS Mean Difference|0.16|||||2-Sided|95.0|-0.01|0.34||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704335|NCT00924560|3135008|Superiority or Other||LS Mean Difference|-0.04|||||2-Sided|95.0|-0.2|0.11||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704336|NCT00924560|3135008|Superiority or Other||LS mean Difference|0.13|||||2-Sided|95.0|-0.03|0.28||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704337|NCT00924560|3135009|Superiority or Other||LS Mean Difference|0.0|||||2-Sided|0.95|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704338|NCT00924560|3135009|Superiority or Other||LS Mean Difference|0.01|||||2-Sided|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704339|NCT00924560|3135009|Superiority or Other||LS Mean Difference|0.0|||||2-Sided|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704340|NCT00924560|3135009|Superiority or Other||LS Mean Difference|0.0|||||2-Sided|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704341|NCT00924560|3135010|Superiority or Other||LS Mean Difference|-0.74|||||2-Sided|95.0|-1.05|-0.42||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704342|NCT00924560|3135010|Superiority or Other||LS Mean Difference|-0.07|||||2-Sided|95.0|-0.39|0.24||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704343|NCT00924560|3135010|Superiority or Other||LS mean Difference|-0.43|||||2-Sided|95.0|-0.68|-0.18||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704344|NCT00924560|3135010|Superiority or Other||LS Mean Difference|0.17|||||2-Sided|95.0|-0.08|0.42||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704345|NCT00924560|3135011|Superiority or Other||LS Mean Difference|-0.01|||||2-Sided|95.0|-0.02|-0.01||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704346|NCT00924560|3135011|Superiority or Other||LS Mean Difference|0.0|||||2-Sided|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 12. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704347|NCT00924560|3135011|Superiority or Other||LS Mean Difference|-0.01|||||2-Sided|95.0|-0.01|0.0||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704348|NCT00924560|3135011|Superiority or Other||LS Mean Difference|0.0|||||2-Sided|95.0|0.0|0.01||||||Comparison of Change from Baseline to Month 6. ANCOVA model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704349|NCT00924560|3135012|Non-Inferiority or Equivalence|28-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than -3%.|LS Mean Difference|-1.05|||||2-Sided|95.0|-1.49|-0.61|||||Difference = OC group minus the untreated control|The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704350|NCT00924560|3135012|Non-Inferiority or Equivalence|91-day levonorgestrel OC was declared to be non-inferior to the untreated control group if the lower bound of the 2-sided 95% confidence interval (CI) was greater than –3%.|LS Mean Difference|-0.23|||||2-Sided|95.0|-0.67|0.2|||||Difference = OC group minus the untreated control|The primary efficacy endpoint (percent change from baseline to 12 months in lumbar spine BMD) was analyzed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and chronological age, body weight, and Baseline value as covariates.|
1704351|NCT00924508|3135014|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline and post-treatment comparison|
1704352|NCT00924508|3135014|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline and post-treatment comparison|
1704353|NCT00924508|3135014|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Baseline and post-treatment comparison|
1704354|NCT00924482|3135015|Superiority or Other||Correlation Coefficient (R^2)|0.63||||||95.0|||||||||
1704355|NCT00924469|3135017|Superiority or Other||Adjusted mean ratio|0.17|||<|0.0001||90.0|0.098|0.289||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for DHT concentration at Week 12|
1704356|NCT00924469|3135020|Superiority or Other||Relative risk|2.744||||0.3427||90.0|1.018|5.015|||Cochran-Mantel-Haenszel|||Statistical Analysis 1 for CR at Week 24|
1704357|NCT00924469|3135021|Superiority or Other||Relative risk|1.131||||0.2319||90.0|0.956|1.337|||Cochran-Mantel-Haenszel|||Statistical Analysis 2 for PSA response at Week 24|
1704358|NCT00924469|3135021|Superiority or Other||Relative risk|25.533|||<|0.0001||90.0|4.989|130.68|||Cochran-Mantel-Haenszel|||Statistical Analysis 1 for PSA response at Week 12|
1704359|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|1.22||||0.2673||90.0|0.916|1.625||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 14 for serum delta-4-androstenedione concentration at Week 24|
1704360|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|0.42|||<|0.0001||90.0|0.29|0.615||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 13 for serum delta-4-androstenedione concentration at Week 12|
1704361|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|1.2|||<|0.7061||90.0|0.53|2.73|||ANCOVA|||Statistical Analysis 12 for serum DHEA-sulfate concentration at Week 24|
1704362|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|0.01|||<|0.0001||90.0|0.008|0.028||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 11 for serum DHEA-sulfate concentration at Week 12|
1704363|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|0.55|||<|0.1329||90.0|0.286|1.06||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 10 for serum DHEA-glucuronide concentration at Week 24|
1704364|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|0.1|||<|0.0001||90.0|0.055|0.189||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 9 for serum DHEA-glucuronide concentration at Week 12|
1704365|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|1.24|||<|0.5144||90.0|0.717|2.137||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 8 for serum DHEA concentration at Week 24|
1704366|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|0.04|||<|0.0001||90.0|0.023|0.073||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 7 for serum DHEA concentration at Week 12|
1704367|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|1.22|||<|0.2494||90.0|0.916|1.625||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 6 for serum androsterone concentration at Week 24|
1704368|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|0.42|||<|0.0003||90.0|0.29|0.615||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 5 for serum Androsterone concentration at Week 12|
1704369|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|0.84|||<|0.3965||90.0|0.589|1.188||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 4 for serum DHT concentration at Week 24|
1704370|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|0.75|||<|0.1515||90.0|0.54|1.044||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 3 for serum DHT concentration at Week 12|
1704371|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|0.84|||<|0.4364||90.0|0.571|1.225||Test for no difference of natural log transformed values between treatments was calculated using ANCOVA adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 2 for serum testosterone concentration at Week 24|
1704372|NCT00924469|3135022|Superiority or Other||Adjusted mean ratio|0.14|||<|0.0001||90.0|0.097|0.207||Test for no difference of natural log transformed values between treatments was calculated using analysis of covariance (ANCOVA) adjusting for Baseline risk factor and Baseline androgen.|ANCOVA|||Statistical Analysis 1 for serum testosterone concentration at Week 12|
1704373|NCT00924469|3135023|Superiority or Other||Adjusted mean ratio|0.79||||0.5767||90.0|0.398|1.581||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 4 for DHEA concentration at Week 24|
1704374|NCT00924469|3135023|Superiority or Other||Adjusted mean ratio|0.03|||<|0.0001||90.0|0.017|0.05||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 3 for DHEA concentration at Week 12|
1704375|NCT00924469|3135023|Superiority or Other||Adjusted mean ratio|1.13|||<|0.5061||90.0|0.828|1.554||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for androstenedione concentration at Week 24|
1704376|NCT00924469|3135023|Superiority or Other||Adjusted mean ratio|0.32|||<|0.0001||90.0|0.239|0.418||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for androstenedione concentration at Week 12|
1704377|NCT00924469|3135024|Superiority or Other||Adjusted mean ratio|0.82||||0.6639||90.0|0.386|1.746||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 2 for DHT concentration at Week 24|
1704378|NCT00924469|3135024|Superiority or Other||Adjusted mean ratio|1.43||||0.1423||90.0|0.956|2.145||Test for no difference of natural log transformed values between treatments was calculated using two-way ANOVA adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for testosterone concentration at Week 24|
1704379|NCT00924469|3135025|Superiority or Other||Adjusted mean ratio|0.61||||0.0216||90.0|0.429|0.865||Test for no difference of natural log transformed values between treatments was calculated using two-way analysis of variance (ANOVA) adjusting for Baseline risk factor.|ANOVA|||Statistical Analysis 1 for testosterone concentration at Week 12|
1704380|NCT00924313|3135043|Superiority|||||||0.407|||||||Spearman rank correlation||||
1704381|NCT00924313|3135045|Superiority|||||||0.55|||||||Spearman rank correlation||||
1704382|NCT00924313|3135048|Superiority|||||||0.65||||||The reported p-value is representative of the BPH high uptake level.|Spearman rank correlation||||
1704383|NCT00924313|3135048|Superiority||||||<|0.0001||||||The reported p-value is representative of the difference in levels of the histopathologic confirmed tumor and normal prostate tissue.|Spearman rank correlation||||
1704384|NCT00924170|3135073|Superiority||||||<|0.0001|||||||Kaplan Meier|||Published response duration of 15 patients with leukemic adult T cell leukemia treated with Alemtuzumab.|
1704385|NCT00923598|3135141|Equivalence|A method by Armitage et al was used, where by equivalence of treatments would be concluded if the 95% CI for the difference fell within the prespecified tolerated interval. Under these assumptions, a trial with 36 subjects (72 limbs) would correctly conclude there is no treatment difference with probability 80%, and incorrectly conclude equivalence when there is a difference of 20% with probability 5%.|Mean Difference (Final Values)|3.0||||0.05|2-Sided|95.0|-10.0|17.0|||Fisher Exact||||
1704386|NCT00923351|3135153|Superiority or Other|||||||0.043|||||||Fisher Exact||||
1704387|NCT00923260|3135158|Superiority or Other|||||||0.56|||||||t-test, 2 sided||||
1704388|NCT00923260|3135159|Superiority or Other|||||||0.72|||||||t-test, 2 sided||||
1704389|NCT00923260|3135160|Superiority or Other|||||||0.43|||||||t-test, 2 sided||||
1704390|NCT00923260|3135161|Superiority or Other|||||||0.57|||||||t-test, 2 sided||||
1704391|NCT00923260|3135162|Superiority or Other|||||||0.59|||||||t-test, 2 sided||||
1704392|NCT00923260|3135163|Superiority or Other|||||||0.52|||||||t-test, 2 sided||||
1704393|NCT00923260|3135164|Superiority or Other|||||||0.64|||||||t-test, 2 sided||||
1704394|NCT00923260|3135165|Superiority or Other|||||||0.32|||||||t-test, 2 sided||||
1704395|NCT00923260|3135166|Superiority or Other|||||||0.71|||||||t-test, 2 sided||||
1704396|NCT00923260|3135167|Superiority or Other|||||||0.08|||||||t-test, 2 sided||||
1704397|NCT00923260|3135168|Superiority or Other|||||||0.68|||||||t-test, 2 sided||||
1704398|NCT00923260|3135169|Superiority or Other|||||||0.72|||||||t-test, 2 sided||||
1704399|NCT00923260|3135170|Superiority or Other|||||||0.42|||||||t-test, 2 sided||||
1704400|NCT00923260|3135171|Superiority or Other|||||||0.64|||||||t-test, 2 sided||||
1704401|NCT00923260|3135172|Superiority or Other|||||||0.28|||||||t-test, 2 sided||||
1704402|NCT00923260|3135173|Superiority or Other|||||||0.87|||||||t-test, 2 sided||||
1704403|NCT00923260|3135174|Superiority or Other|||||||0.57|||||||t-test, 2 sided||||
1704404|NCT00923260|3135175|Superiority or Other|||||||0.74|||||||t-test, 2 sided||||
1704405|NCT00923260|3135176|Superiority or Other|||||||0.65|||||||t-test, 2 sided||||
1704406|NCT00923260|3135177|Superiority or Other|||||||0.55|||||||t-test, 2 sided||||
1704407|NCT00923260|3135178|Superiority or Other|||||||0.61|||||||t-test, 2 sided||||
1704408|NCT00923260|3135179|Superiority or Other|||||||0.85|||||||t-test, 2 sided||||
1704409|NCT00923260|3135180|Superiority or Other|||||||0.97|||||||t-test, 2 sided||||
1704410|NCT00923260|3135181|Superiority or Other|||||||0.44|||||||t-test, 2 sided||||
1704411|NCT00923260|3135182|Superiority or Other|||||||0.96|||||||t-test, 2 sided||||
1704412|NCT00923260|3135183|Superiority or Other|||||||0.99|||||||t-test, 2 sided||||
1704413|NCT00923260|3135184|Superiority or Other|||||||0.07|||||||t-test, 2 sided||||
1704414|NCT00923260|3135185|Superiority or Other|||||||0.035|||||||t-test, 2 sided||||
1704415|NCT00923260|3135186|Superiority or Other|||||||0.44|||||||t-test, 2 sided||||
1704416|NCT00923260|3135187|Superiority or Other|||||||0.4|||||||t-test, 2 sided||||
1704417|NCT00923260|3135188|Superiority or Other|||||||0.18|||||||t-test, 2 sided||||
1704418|NCT00923260|3135189|Superiority or Other|||||||0.16|||||||t-test, 2 sided||||
1704419|NCT00923260|3135190|Superiority or Other|||||||0.1|||||||t-test, 2 sided||||
1704420|NCT00923260|3135191|Superiority or Other|||||||0.18|||||||t-test, 2 sided||||
1704421|NCT00923260|3135192|Superiority or Other|||||||0.42|||||||t-test, 2 sided||||
1704422|NCT00923260|3135193|Superiority or Other|||||||0.21|||||||t-test, 2 sided||||
1704423|NCT00923260|3135194|Superiority or Other|||||||0.14|||||||t-test, 2 sided||||
1704424|NCT00923260|3135195|Superiority or Other|||||||0.038|||||||t-test, 2 sided||||
1704425|NCT00923260|3135196|Superiority or Other|||||||0.64|||||||t-test, 2 sided||||
1704426|NCT00923260|3135197|Superiority or Other|||||||0.67|||||||t-test, 2 sided||||
1704427|NCT00923260|3135198|Superiority or Other|||||||0.72|||||||t-test, 2 sided||||
1704428|NCT00923260|3135199|Superiority or Other|||||||0.74|||||||t-test, 2 sided||||
1704429|NCT00923260|3135200|Superiority or Other|||||||0.94|||||||t-test, 2 sided||||
1704430|NCT00923260|3135201|Superiority or Other|||||||0.75|||||||t-test, 2 sided||||
1704431|NCT00923260|3135202|Superiority or Other|||||||0.47|||||||t-test, 2 sided||||
1704432|NCT00923260|3135203|Superiority or Other|||||||0.39|||||||t-test, 2 sided||||
1704433|NCT00923260|3135204|Superiority or Other|||||||0.33|||||||t-test, 2 sided||||
1704434|NCT00923260|3135205|Superiority or Other|||||||0.65|||||||t-test, 2 sided||||
1704435|NCT00923260|3135206|Superiority or Other|||||||0.21|||||||t-test, 2 sided||||
1704436|NCT00923260|3135207|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1704437|NCT00923260|3135208|Superiority or Other|||||||0.92|||||||t-test, 2 sided||||
1704438|NCT00923260|3135209|Superiority or Other|||||||0.64|||||||t-test, 2 sided||||
1704439|NCT00923260|3135210|Superiority or Other|||||||0.2|||||||t-test, 2 sided||||
1704440|NCT00923260|3135211|Superiority or Other|||||||0.15|||||||t-test, 2 sided||||
1704441|NCT00923260|3135212|Superiority or Other|||||||0.01|||||||t-test, 2 sided||||
1704442|NCT00923260|3135213|Superiority or Other|||||||0.92|||||||t-test, 2 sided||||
1704443|NCT00923260|3135214|Superiority or Other|||||||0.81|||||||t-test, 2 sided||||
1704444|NCT00923260|3135215|Superiority or Other|||||||0.45|||||||t-test, 2 sided||||
1704445|NCT00923260|3135216|Superiority or Other|||||||0.76|||||||t-test, 2 sided||||
1704446|NCT00923260|3135217|Superiority or Other|||||||0.6|||||||t-test, 2 sided||||
1704447|NCT00923260|3135218|Superiority or Other|||||||0.86|||||||t-test, 2 sided||||
1704448|NCT00923260|3135219|Superiority or Other|||||||0.96|||||||t-test, 2 sided||||
1704451|NCT00923247|3135223|Superiority or Other|||||||0.01|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase I portion. To assess whether presence of vandetanib significantly altered bortezomib volume of distribution.|
1704452|NCT00923247|3135224|Superiority or Other|||||||0.016|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib clearance.|
1704453|NCT00923247|3135225|Superiority or Other|||||||0.44|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib half-life.|
1704454|NCT00923247|3135226|Superiority or Other|||||||0.052|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1 day 1 vs. cycle 3 day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib AUCinf (normalized to dose).|
1704455|NCT00923247|3135227|Superiority or Other|||||||0.019|||||||Mann-Whitney|(nonparametric unpaired t-test; assumed homoscedasticity)||Patients given bortezomib on cycle 1, day 1 vs. cycle 3, day 1. A paired analysis among same 14 patients on Phase 1 portion. To assess whether presence of vandetanib significantly altered bortezomib Cmax (normalized to dose).|
1704456|NCT00923091|3135269|Superiority or Other|||||||0.0503|||||||ANCOVA||||
1704457|NCT00923091|3135270|Superiority or Other|||||||0.01301|||||||ANCOVA||||
1704458|NCT00923091|3135270|Superiority or Other|||||||0.1301|||||||ANCOVA||||
1704459|NCT00923091|3135271|Superiority or Other|||||||0.4964|||||||Cochran-Mantel-Haenszel||||
1704460|NCT00923091|3135272|Superiority or Other|||||||0.2765|||||||ANCOVA||||
1704461|NCT00923091|3135273|Superiority or Other|||||||0.1135|||||||ANCOVA||||
1704462|NCT00923091|3135274|Superiority or Other|||||||0.2529|||||||Cochran-Mantel-Haenszel||||
1704463|NCT00923091|3135274|Superiority or Other|||||||0.2033|||||||Cochran-Mantel-Haenszel||||
1704464|NCT00923091|3135274|Superiority or Other|||||||0.0037|||||||Cochran-Mantel-Haenszel||||
1704465|NCT00923091|3135274|Superiority or Other|||||||0.2529|||||||Cochran-Mantel-Haenszel||||
1704466|NCT00923091|3135274|Superiority or Other|||||||0.0295|||||||Cochran-Mantel-Haenszel||||
1704467|NCT00923091|3135275|Superiority or Other|||||||0.0006|||||||ANCOVA||||
1704468|NCT00923091|3135275|Superiority or Other|||||||0.0034|||||||ANCOVA||||
1704469|NCT00923091|3135275|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1704470|NCT00923091|3135275|Superiority or Other||||||<|0.0008|||||||ANCOVA||||
1704471|NCT00923091|3135275|Superiority or Other||||||<|0.0006|||||||ANCOVA||||
1704472|NCT00923091|3135276|Superiority or Other|||||||0.0107|||||||ANCOVA||||
1704473|NCT00923091|3135276|Superiority or Other|||||||0.0071|||||||ANCOVA||||
1704474|NCT00923091|3135276|Superiority or Other|||||||0.008|||||||ANCOVA||||
1704475|NCT00923091|3135276|Superiority or Other|||||||0.0323|||||||ANCOVA||||
1704476|NCT00923091|3135276|Superiority or Other|||||||0.0071|||||||ANCOVA||||
1704477|NCT00923078|3135277|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.98||0.71|2-Sided|95.0|-2.32|1.58|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704478|NCT00923078|3135277|Superiority or Other||Mean Difference (Net)|-1.47|Standard Error of the Mean|0.97||0.13|2-Sided|95.0|-3.41|0.46|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704479|NCT00923078|3135277|Superiority or Other||Mean Difference (Net)|-1.1|Standard Error of the Mean|0.98||0.26|2-Sided|95.0|-3.06|0.85|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704480|NCT00923078|3135278|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|1.27||0.8|2-Sided|95.0|-2.85|2.22|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704481|NCT00923078|3135278|Superiority or Other||Mean Difference (Net)|-0.92|Standard Error of the Mean|1.27||0.47|2-Sided|95.0|-3.45|1.61|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704511|NCT00922272|3135394|Superiority or Other||Mean Difference (Final Values)|0.8||||0.6429|2-Sided|95.0|-2.6|4.1|||ANCOVA|||Behavioral Recognition Index|
1704482|NCT00923078|3135278|Superiority or Other||Mean Difference (Net)|-0.6|Standard Error of the Mean|1.27||0.63|2-Sided|95.0|-3.14|1.93|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704483|NCT00923078|3135279|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|1.04||0.57|2-Sided|95.0|-2.66|1.47|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704484|NCT00923078|3135279|Superiority or Other||Mean Difference (Net)|0.03|Standard Error of the Mean|1.03||0.98|2-Sided|95.0|-2.02|2.07|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704485|NCT00923078|3135279|Superiority or Other||Mean Difference (Net)|0.62|Standard Error of the Mean|1.04||0.55|2-Sided|95.0|-1.45|2.69|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704486|NCT00923078|3135280|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|1.55||0.84|2-Sided|95.0|-3.42|2.78|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704487|NCT00923078|3135280|Superiority or Other||Mean Difference (Net)|-3.24|Standard Error of the Mean|1.55|<|0.05|2-Sided|95.0|-6.34|-0.14|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704488|NCT00923078|3135280|Superiority or Other||Mean Difference (Net)|-2.92|Standard Error of the Mean|1.55|<|0.06|2-Sided|95.0|-6.02|0.18|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704489|NCT00923078|3135281|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.75||0.58|2-Sided|95.0|-1.93|1.08||Post-test scores following Auditory Cognitive Training as compared to Visual Cognitive Training, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704490|NCT00923078|3135281|Superiority or Other||Mean Difference (Net)|-2.45|Standard Error of the Mean|0.75||0.01|2-Sided|95.0|-3.95|-0.94||Post-test scores following Visual Cognitive Training as compared to baseline, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704491|NCT00923078|3135281|Superiority or Other||Mean Difference (Net)|-2.03|Standard Error of the Mean|0.75|<|0.01|2-Sided|95.0|-3.53|-0.52||Post-test scores following Auditory Cognitive Training as compared to baseline, tested at alpha = 0.05 (uncorrected).|Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704492|NCT00923078|3135282|Superiority or Other||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.295||0.59|2-Sided|95.0|-0.75|0.43|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704493|NCT00923078|3135282|Superiority or Other||Mean Difference (Net)|0.51|Standard Error of the Mean|0.295||0.09|2-Sided|95.0|-0.08|1.09|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704494|NCT00923078|3135282|Superiority or Other||Mean Difference (Net)|0.67|Standard Error of the Mean|0.295|<|0.05|2-Sided|95.0|0.08|1.25|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704495|NCT00923078|3135283|Superiority or Other||Mean Difference (Final Values)|-2.92|Standard Error of the Mean|1.02|<|0.01|2-Sided|95.0|-4.95|-0.9|||Mixed Models Analysis||contrast calculated as Auditory Training minus Visual Training|Null hypothesis is that there is no difference between post-training scores in Auditory vs. Visual Cognitive Training conditions. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704496|NCT00923078|3135283|Superiority or Other||Mean Difference (Net)|-0.72|Standard Error of the Mean|1.02|<|0.48|2-Sided|95.0|-2.75|1.31|||Mixed Models Analysis||contrast calculated as baseline minus Visual Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704497|NCT00923078|3135283|Other||Mean Difference (Net)|2.2|Standard Error of the Mean|1.02|<|0.05|2-Sided|95.0|0.17|4.23|||Mixed Models Analysis||contrast calculated as baseline minus Auditory Training|Null hypothesis is that there is no difference between baseline and post-training scores. Linear mixed models tested fixed effects of period (3 levels; baseline, post 4-weeks, post 8 weeks), condition (3 levels; baseline, Auditory Cognitive Training, Visual Cognitive Training) and the period x condition interaction. Final model parameters were selected according to Bayesian Information Criteria. Alpha=.05 (2-sided)|
1704498|NCT00922987|3135291|Superiority or Other||||||<|0.0001|||||||Signed Rank Test||||
1704499|NCT00922974|3135296|Superiority|||||||0.28|||||||t-test, 2 sided|||Assuming that the data are normally distributed, the two sample t-test assuming equal variances will be used to test the hypothesis at the one-sided 0.025 significance level. A mean difference of 7 points represents a clinically meaningful change (CMC). A difference of less than 7 points between the treatment arms will not be considered meaningful, even if it has statistical significance.|
1704500|NCT00922974|3135298|Superiority|||||||0.09||||||Two-sided significance level = 0.05|Chi-squared|||Percentage of patients with any adverse events.|
1704501|NCT00922974|3135298|Superiority|||||||0.93||||||Two-sided significance level = 0.05|Chi-squared|||Percentage of patients with treatment-related adverse events.|
1704502|NCT00922974|3135301|Superiority|||||||0.99|||||||Fisher Exact|||Based on the one-sided exact binomial test with α=0.025 and a 2:1 randomization, 228 patients would be required to detect a 40% improvement in the response rate from 51% (external beam radiation therapy) to 70% (Radiosurgery/SBRT) with a statistical power of 0.80.|
1704503|NCT00922636|3135366|Superiority or Other||Mean Difference (Final Values)|-6.44||||0.002||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.||Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.|
1704504|NCT00922636|3135366|Superiority or Other||Mean Difference (Final Values)|0.16||||0.938||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.||Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.|
1704505|NCT00922636|3135369|Superiority or Other||Mean Difference (Final Values)|-6.04||||0.006||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|The Least Squares (LS) Mean Value is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.|The LS Mean difference was computed as treatment minus placebo.||
1704506|NCT00922636|3135369|Superiority or Other||Mean Difference (Final Values)|-5.74||||0.008||95.0||||Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.|Mixed Models Analysis|The Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.|The LS Mean difference was computed as treatment minus placebo.||
1704507|NCT00922480|3135371|Non-Inferiority|Non-Inferiority||||||0.0001|||||||t-test, 2 sided|Paired t-test|||
1704508|NCT00922480|3135372|Non-Inferiority|Non-Inferiority||||||0.0001|||||||t-test, 2 sided|Paired t-test|||
1704509|NCT00922441|3135373|Other|Efficacy, Safety|||||<|0.05|||||||ANOVA|comparison between the groups|||
1704613|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.39||||0.4574|2-Sided||||||Cochran-Mantel-Haenszel|||Week 12|
1704512|NCT00922272|3135394|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.7418|2-Sided|95.0|-3.8|2.7|||ANCOVA|||Global Executive Composite|
1704513|NCT00922272|3135395|Superiority or Other|||||||0.0146|||||||t-test, 2 sided|||Metacognition Index|
1704514|NCT00922272|3135395|Superiority or Other|||||||0.0461|||||||t-test, 2 sided|||Behavioral Recognition Index|
1704515|NCT00922272|3135395|Superiority or Other|||||||0.0174|||||||t-test, 2 sided|||Global Executive Composite|
1704516|NCT00922272|3135396|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.3482|2-Sided|95.0|-3.5|1.3|||ANCOVA|||Financial Skills|
1704517|NCT00922272|3135396|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.6137|2-Sided|95.0|-4.1|2.4|||ANCOVA|||Communication Skills|
1704518|NCT00922272|3135396|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.4637|2-Sided|95.0|-5.3|2.4|||ANCOVA|||Total Skills|
1704519|NCT00922272|3135397|Superiority or Other|||||||0.0028|||||||t-test, 2 sided|||Financial Skills|
1704520|NCT00922272|3135397|Superiority or Other|||||||0.0002|||||||t-test, 2 sided|||Communication Skills|
1704521|NCT00922272|3135397|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Total Skills|
1704522|NCT00922272|3135398|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.0874|2-Sided|95.0|-5.4|0.4|||ANCOVA||||
1704523|NCT00922272|3135399|Superiority or Other|||||||0.4312|||||||t-test, 2 sided||||
1704524|NCT00922272|3135400|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.4347|2-Sided|95.0|-5.0|2.2|||ANCOVA||||
1704525|NCT00922272|3135401|Superiority or Other|||||||0.366|||||||t-test, 2 sided||||
1704526|NCT00922272|3135402|Superiority or Other||Mean Difference (Final Values)|2.8||||0.1072|2-Sided|95.0|-0.6|6.2|||ANCOVA||||
1704527|NCT00922272|3135403|Superiority or Other|||||||0.0307|||||||t-test, 2 sided||||
1704528|NCT00922272|3135410|Superiority or Other||Mean Difference (Final Values)|1.8||||0.1115|2-Sided|95.0|-0.4|3.9|||ANCOVA|||General Psychopathology subscale|
1704529|NCT00922272|3135410|Superiority or Other||Mean Difference (Final Values)|1.0||||0.1228|2-Sided|95.0|-0.3|2.3|||ANCOVA|||Negative subscale|
1704530|NCT00922272|3135410|Superiority or Other||Mean Difference (Final Values)|0.6||||0.1975|2-Sided|95.0|-0.3|1.5|||ANCOVA|||Positive subscale|
1704531|NCT00922272|3135411|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||General Psychopathology subscale|
1704532|NCT00922272|3135411|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Negative subscale|
1704533|NCT00922272|3135411|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Positive subscale|
1704534|NCT00922272|3135412|Superiority or Other||Mean Difference (Final Values)|0.1||||0.5723|2-Sided|95.0|-0.4|0.7|||ANCOVA|||Attention|
1704535|NCT00922272|3135412|Superiority or Other||Mean Difference (Final Values)|0.2||||0.4835|2-Sided|95.0|-0.3|0.7|||ANCOVA|||Anhedonia-Asociality|
1704536|NCT00922272|3135412|Superiority or Other||Mean Difference (Final Values)|0.1||||0.5215|2-Sided|95.0|-0.3|0.6|||ANCOVA|||Avolition-Apathy|
1704537|NCT00922272|3135412|Superiority or Other||Mean Difference (Final Values)|0.6||||0.0584|2-Sided|95.0|0.0|1.1|||ANCOVA|||Alogia|
1704538|NCT00922272|3135412|Superiority or Other||Mean Difference (Final Values)|0.0||||0.8771|2-Sided|95.0|-0.4|0.5|||ANCOVA|||Affective Flattening|
1704539|NCT00922272|3135413|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Attention|
1704540|NCT00922272|3135413|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Anhedonia-Asociality|
1704541|NCT00922272|3135413|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Avolition-Apathy|
1704542|NCT00922272|3135413|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Alogia|
1704543|NCT00922272|3135413|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Affective Flattening|
1704544|NCT00922272|3135414|Superiority or Other|||||||0.6705|||||||Fisher Exact||||
1704545|NCT00922272|3135415|Superiority or Other||Mean Difference (Final Values)|2.3||||0.4182|2-Sided|95.0|-3.4|8.1|||ANCOVA||||
1704546|NCT00922272|3135417|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1704547|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.04||||0.8002|2-Sided|95.0|-0.38|0.29|||ANCOVA|||Change at Week 100|
1704548|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.15||||0.3057|2-Sided|95.0|-0.14|0.43|||ANCOVA|||Change at Week 100|
1704549|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.2||||0.1862|2-Sided|95.0|-0.1|0.5|||ANCOVA|||Change at Week 100|
1704550|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.19||||0.2439|2-Sided|95.0|-0.13|0.5|||ANCOVA|||Change at Week 88|
1704551|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.12||||0.4725|2-Sided|95.0|-0.22|0.47|||ANCOVA|||Change at Week 88|
1704552|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.06||||0.7108|2-Sided|95.0|-0.36|0.25|||ANCOVA|||Change at Week 88|
1704553|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.08||||0.6449|2-Sided|95.0|-0.25|0.4|||ANCOVA|||Change at Week 76|
1704554|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.05||||0.7591|2-Sided|95.0|-0.37|0.27|||ANCOVA|||Change at Week 76|
1704555|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.12||||0.4076|2-Sided|95.0|-0.42|0.17|||ANCOVA|||Change at Week 76|
1704556|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.13||||0.4504|2-Sided|95.0|-0.21|0.47|||ANCOVA|||Change at Week 64|
1704557|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.01||||0.9762|2-Sided|95.0|-0.35|0.36|||ANCOVA|||Change at Week 64|
1704558|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.14||||0.4256|2-Sided|95.0|-0.47|0.2|||ANCOVA|||Change at Week 64|
1704559|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.19||||0.3101|2-Sided|95.0|-0.18|0.56|||ANCOVA|||Change at Week 52|
1704560|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.11||||0.6002|2-Sided|95.0|-0.29|0.5|||ANCOVA|||Change at Week 52|
1704561|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.09||||0.6172|2-Sided|95.0|-0.44|0.26|||ANCOVA|||Change at Week 52|
1704562|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.15||||0.3788|2-Sided|95.0|-0.19|0.49|||ANCOVA|||Change at Week 40|
1704563|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.11||||0.5427|2-Sided|95.0|-0.24|0.46|||ANCOVA|||Change at Week 40|
1704564|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.04||||0.7912|2-Sided|95.0|-0.36|0.27|||ANCOVA|||Change at Week 40|
1704565|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.02||||0.8881|2-Sided|95.0|-0.28|0.32|||ANCOVA|||Change at Week 28|
1704566|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.09||||0.5493|2-Sided|95.0|-0.21|0.39|||ANCOVA|||Change at Week 28|
1704567|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.07||||0.6214|2-Sided|95.0|-0.21|0.36|||ANCOVA|||Change at Week 28|
1704568|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.01||||0.9582|2-Sided|95.0|-0.23|0.22|||ANCOVA|||Change at Week 16|
1704569|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.08||||0.5016|2-Sided|95.0|-0.15|0.31|||ANCOVA|||Change at Week 16|
1704570|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.08||||0.4656|2-Sided|95.0|-0.14|0.3|||ANCOVA|||Change at Week 16|
1704571|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.06||||0.489|2-Sided|95.0|-0.22|0.11|||ANCOVA|||Change at Week 8|
1704572|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.08||||0.4393|2-Sided|95.0|-0.27|0.12|||ANCOVA|||Change at Week 8|
1704573|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.02||||0.816|2-Sided|95.0|-0.22|0.18|||ANCOVA|||Change at Week 8|
1704574|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.15||||0.0085|2-Sided|95.0|-0.27|-0.04|||ANCOVA|||Change at Week 4|
1704575|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.24|||<|0.001|2-Sided|95.0|-0.36|-0.11|||ANCOVA|||Change at Week 4|
1704576|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.08|||<|0.2259|2-Sided|95.0|-0.22|0.05|||ANCOVA|||Change at Week 4|
1704577|NCT00922207|3135422|Superiority or Other||LS Mean Difference|-0.08|||<|0.5003|2-Sided|95.0|-0.3|0.15|||ANCOVA|||Baseline|
1704578|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.13|||<|0.1867|2-Sided|95.0|-0.06|0.33|||ANCOVA|||Baseline|
1704579|NCT00922207|3135422|Superiority or Other||LS Mean Difference|0.21|||<|0.0649|2-Sided|95.0|-0.01|0.43|||ANCOVA|||Baseline|
1704580|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.71||||0.2655|2-Sided||||||Cochran-Mantel-Haenszel|||Week 100|
1704581|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.6||||0.0832|2-Sided||||||Cochran-Mantel-Haenszel|||Week 100|
1704582|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.84||||0.4606|2-Sided||||||Cochran-Mantel-Haenszel|||Week 100|
1704583|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.53||||0.0369|2-Sided||||||Cochran-Mantel-Haenszel|||Week 88|
1704584|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.52||||0.0283|2-Sided||||||Cochran-Mantel-Haenszel|||Week 88|
1704585|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.98||||0.8608|2-Sided||||||Cochran-Mantel-Haenszel|||Week 88|
1704586|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.7||||0.2145|2-Sided||||||Cochran-Mantel-Haenszel|||Week 76|
1704587|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.89||||0.6708|2-Sided||||||Cochran-Mantel-Haenszel|||Week 76|
1704588|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.26||||0.4389|2-Sided||||||Cochran-Mantel-Haenszel|||Week 76|
1704589|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.8||||0.4268|2-Sided||||||Cochran-Mantel-Haenszel|||Week 64|
1704590|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.65||||0.1588|2-Sided||||||Cochran-Mantel-Haenszel|||Week 64|
1704591|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.81||||0.5372|2-Sided||||||Cochran-Mantel-Haenszel|||Week 64|
1704592|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.08||||0.7268|2-Sided||||||Cochran-Mantel-Haenszel|||Week 52|
1704593|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.03||||0.906|2-Sided||||||Cochran-Mantel-Haenszel|||Week 52|
1704594|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.95||||0.901|2-Sided||||||Cochran-Mantel-Haenszel|||Week 52|
1704595|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.42||||0.2166|2-Sided||||||Cochran-Mantel-Haenszel|||Week 46|
1704596|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.84||||0.6094|2-Sided||||||Cochran-Mantel-Haenszel|||Week 46|
1704597|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.59||||0.091|2-Sided||||||Cochran-Mantel-Haenszel|||Week 46|
1704598|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.37||||0.3104|2-Sided||||||Cochran-Mantel-Haenszel|||Week 40|
1704599|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.89||||0.7167|2-Sided||||||Cochran-Mantel-Haenszel|||Week 40|
1704600|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.65||||0.182|2-Sided||||||Cochran-Mantel-Haenszel|||Week 40|
1704601|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.08||||0.7645|2-Sided||||||Cochran-Mantel-Haenszel|||Week 34|
1704602|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.75||||0.3804|2-Sided||||||Cochran-Mantel-Haenszel|||Week 34|
1704603|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.69||||0.2709|2-Sided||||||Cochran-Mantel-Haenszel|||Week 34|
1704604|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.37||||0.3154|2-Sided||||||Cochran-Mantel-Haenszel|||Week 28|
1704605|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.16||||0.6774|2-Sided||||||Cochran-Mantel-Haenszel|||Week 28|
1704606|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.84||||0.6214|2-Sided||||||Cochran-Mantel-Haenszel|||Week 28|
1704607|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.77||||0.0818|2-Sided||||||Cochran-Mantel-Haenszel|||Week 22|
1704608|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.16||||0.6702|2-Sided||||||Cochran-Mantel-Haenszel|||Week 22|
1704609|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.65||||0.2025|2-Sided|95.0|||||Cochran-Mantel-Haenszel|||Week 22|
1704610|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.26||||0.5263|2-Sided||||||Cochran-Mantel-Haenszel|||Week 16|
1704611|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.03||||0.9321|2-Sided||||||Cochran-Mantel-Haenszel|||Week 16|
1704612|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|0.81||||0.5824|2-Sided||||||Cochran-Mantel-Haenszel|||Week 16|
1704619|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.5||||0.6818|2-Sided||||||Cochran-Mantel-Haenszel|||Baseline|
1704620|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|2.11||||0.3939|2-Sided||||||Cochran-Mantel-Haenszel|||Baseline|
1704621|NCT00922207|3135423|Superiority or Other||Odds Ratio (OR)|1.41||||0.6921|2-Sided||||||Cochran-Mantel-Haenszel|||Baseline|
1704622|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.8||||0.4066|2-Sided|95.0|0.43|1.48|||Cochran-Mantel-Haenszel|||Week 100|
1704623|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.67||||0.2112|2-Sided|95.0|0.36|1.27|||Cochran-Mantel-Haenszel|||Week 100|
1704624|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.84||||0.5596|2-Sided|95.0|0.44|1.62|||Cochran-Mantel-Haenszel|||Week 100|
1704625|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.73||||0.2847|2-Sided|95.0|0.38|1.38|||Cochran-Mantel-Haenszel|||Week 88|
1704626|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.74||||0.3489|2-Sided|95.0|0.39|1.4|||Cochran-Mantel-Haenszel|||Week 88|
1704627|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|1.02||||0.998|2-Sided|95.0|0.52|1.98|||Cochran-Mantel-Haenszel|||Week 88|
1704628|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.68||||0.2073|2-Sided|95.0|0.36|1.27|||Cochran-Mantel-Haenszel|||Week 76|
1704629|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.57||||0.0904|2-Sided|95.0|0.3|1.08|||Cochran-Mantel-Haenszel|||Week 76|
1704630|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.84||||0.6148|2-Sided|95.0|0.43|1.64|||Cochran-Mantel-Haenszel|||Week 76|
1704631|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.72||||0.2674|2-Sided|95.0|0.38|1.38|||Cochran-Mantel-Haenszel|||Week 64|
1704632|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.7||||0.2919|2-Sided|95.0|0.37|1.35|||Cochran-Mantel-Haenszel|||Week 64|
1704633|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.97||||0.9861|2-Sided|95.0|0.49|1.9|||Cochran-Mantel-Haenszel|||Week 64|
1704634|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.69||||0.2362|2-Sided|95.0|0.36|1.34|||Cochran-Mantel-Haenszel|||Week 52|
1704635|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.69||||0.2576|2-Sided|95.0|0.35|1.34|||Cochran-Mantel-Haenszel|||Week 52|
1704636|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.99||||0.9584|2-Sided|95.0|0.5|1.99|||Cochran-Mantel-Haenszel|||Week 52|
1704637|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.75||||0.3882|2-Sided|95.0|0.36|1.53|||Cochran-Mantel-Haenszel|||Week 40|
1704638|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.79||||0.5|2-Sided|95.0|0.38|1.61|||Cochran-Mantel-Haenszel|||Week 40|
1704639|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|1.05||||0.8502|2-Sided|95.0|0.5|2.22|||Cochran-Mantel-Haenszel|||Week 40|
1704640|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.61||||0.2414|2-Sided|95.0|0.26|1.44|||Cochran-Mantel-Haenszel|||Week 28|
1704641|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.64||||0.305|2-Sided|95.0|0.27|1.52|||Cochran-Mantel-Haenszel|||Week 28|
1704642|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|1.05||||0.8796|2-Sided|95.0|0.41|2.66|||Cochran-Mantel-Haenszel|||Week 28|
1704643|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.76||||0.5818|2-Sided|95.0|0.29|2.03|||Cochran-Mantel-Haenszel|||Week 16|
1704644|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.59||||0.3192|2-Sided|95.0|0.2|1.69|||Cochran-Mantel-Haenszel|||Week 16|
1704645|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|0.77||||0.651|2-Sided|95.0|0.26|2.31|||Cochran-Mantel-Haenszel|||Week 16|
1704646|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|1.5||||0.5544|2-Sided|95.0|0.41|5.5|||Cochran-Mantel-Haenszel|||Week 8|
1704647|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|1.57||||0.5068|2-Sided|95.0|0.43|5.77|||Cochran-Mantel-Haenszel|||Week 8|
1704648|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|1.05||||0.9385|2-Sided|95.0|0.33|3.38|||Cochran-Mantel-Haenszel|||Week 8|
1704649|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|4.04||||0.1858|2-Sided|95.0|0.44|36.89|||Cochran-Mantel-Haenszel|||Week 4|
1704650|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|5.35||||0.0927|2-Sided|95.0|0.61|46.76|||Cochran-Mantel-Haenszel|||Week 4|
1704651|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|1.32||||0.7044|2-Sided|95.0|0.34|5.09|||Cochran-Mantel-Haenszel|||Week 4|
1704652|NCT00922207|3135425|Superiority or Other|||||||0.1761|||||||Cochran-Mantel-Haenszel|||Baseline|
1704653|NCT00922207|3135425|Superiority or Other|||||||0.0788|||||||Cochran-Mantel-Haenszel|||Baseline|
1704654|NCT00922207|3135425|Superiority or Other||Odds Ratio (OR)|1.59||||0.6107|2-Sided|95.0|0.26|9.71|||Cochran-Mantel-Haenszel|||Baseline|
1704655|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.4||||0.2752|2-Sided|95.0|-0.32|1.11|||ANCOVA|||Change at Week 100|
1704656|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.17||||0.6323|2-Sided|95.0|-0.53|0.88|||ANCOVA|||Change at Week 100|
1704657|NCT00922207|3135426|Superiority or Other||LS Mean Difference|-0.21||||0.5608|2-Sided|95.0|-0.92|0.5|||ANCOVA|||Change at Week 100|
1704658|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.9||||0.0113|2-Sided|95.0|0.21|1.6|||ANCOVA|||Change at Week 88|
1704659|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.52||||0.1371|2-Sided|95.0|-0.17|1.22|||ANCOVA|||Change at Week 88|
1704660|NCT00922207|3135426|Superiority or Other||LS Mean Difference|-0.36||||0.3183|2-Sided|95.0|-1.07|0.35|||ANCOVA|||Change at Week 88|
1704661|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.81||||0.0311|2-Sided|95.0|0.07|1.55|||ANCOVA|||Change at Week 76|
1704662|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.3||||0.4027|2-Sided|95.0|-0.41|1.01|||ANCOVA|||Change at Week 76|
1704663|NCT00922207|3135426|Superiority or Other||LS Mean Difference|-0.54||||0.1347|2-Sided|95.0|-1.24|0.17|||ANCOVA|||Change at Week 76|
1704664|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.72||||0.0412|2-Sided|95.0|0.03|1.41|||ANCOVA|||Change at Week 64|
1704665|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.23||||0.5045|2-Sided|95.0|-0.45|0.92|||ANCOVA|||Change at Week 64|
1704666|NCT00922207|3135426|Superiority or Other||LS Mean Difference|-0.49||||0.1599|2-Sided|95.0|-1.17|0.19|||ANCOVA|||Change at Week 64|
1704667|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.51||||0.1602|2-Sided|95.0|-0.2|1.23|||ANCOVA|||Change at Week 52|
1704668|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.57||||0.1122|2-Sided|95.0|-0.13|1.28|||ANCOVA|||Change at Week 52|
1704669|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.04||||0.9014|2-Sided|95.0|-0.65|0.74|||ANCOVA|||Change at Week 52|
1704670|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.3||||0.3585|2-Sided|95.0|-0.34|0.93|||ANCOVA|||Change at Week 40|
1704671|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.67||||0.0429|2-Sided|95.0|0.02|1.31|||ANCOVA|||Change at Week 40|
1704672|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.36||||0.2509|2-Sided|95.0|-0.26|0.98|||ANCOVA|||Change at Week 40|
1704673|NCT00922207|3135426|Superiority or Other||LS Mean Difference|-0.23||||0.4354|2-Sided|95.0|-0.82|0.35|||ANCOVA|||Change at Week 28|
1704674|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.51||||0.0943|2-Sided|95.0|-0.09|1.11|||ANCOVA|||Change at Week 28|
1704675|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.73||||0.0094|2-Sided|95.0|0.18|1.27|||ANCOVA|||Change at Week 28|
1704676|NCT00922207|3135426|Superiority or Other||LS Mean Difference|-1.65|||<|0.001|2-Sided|95.0|-2.15|-1.14|||ANCOVA|||Change at Week 16|
1704677|NCT00922207|3135426|Superiority or Other||LS Mean Difference|-0.02|||<|0.9557|2-Sided|95.0|-0.56|0.53|||ANCOVA|||Change at Week 16|
1704678|NCT00922207|3135426|Superiority or Other||LS Mean Difference|1.62|||<|0.001|2-Sided|95.0|1.16|2.08|||ANCOVA|||Change at Week 16|
1704679|NCT00922207|3135426|Superiority or Other||LS Mean Difference|-2.26|||<|0.001|2-Sided|95.0|-2.61|-1.9|||ANCOVA|||Change at Week 8|
1704680|NCT00922207|3135426|Superiority or Other||LS Mean Difference|-0.55|||<|0.0071|2-Sided|95.0|-0.95|-0.15|||ANCOVA|||Change at Week 8|
1704681|NCT00922207|3135426|Superiority or Other||LS Mean Difference|1.7|||<|0.001|2-Sided|95.0|1.34|2.06|||ANCOVA|||Change at Week 8|
1704682|NCT00922207|3135426|Superiority or Other||LS Mean Difference|-2.54|||<|0.001|2-Sided|95.0|-2.81|-2.27|||ANCOVA|||Change at Week 4|
1704683|NCT00922207|3135426|Superiority or Other||LS Mean Difference|-1.92|||<|0.001|2-Sided|95.0|-2.19|-1.65|||ANCOVA|||Change at Week 4|
1704684|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.62|||<|0.001|2-Sided|95.0|0.34|0.89|||ANCOVA|||Change at Week 4|
1704685|NCT00922207|3135426|Superiority or Other||LS Mean Difference|-0.1|||<|0.515|2-Sided|95.0|-0.42|0.21|||ANCOVA|||Baseline|
1704686|NCT00922207|3135426|Superiority or Other||LS Mean Difference|0.23|||<|0.1114|2-Sided|95.0|-0.05|0.52|||ANCOVA|||Baseline|
1704687|NCT00922207|3135426|Superiority or Other||Least Squares (LS) Mean Difference|0.34|||<|0.0353|2-Sided|95.0|0.02|0.66|||ANCOVA|||Baseline|
1704688|NCT00922207|3135427|Superiority or Other||Odds Ratio (OR)|0.74||||0.2916|2-Sided|95.0|0.39|1.38|||Cochran-Mantel-Haenszel||||
1704689|NCT00922207|3135427|Superiority or Other||Odds Ratio (OR)|0.66||||0.1977|2-Sided|95.0|0.35|1.26|||Cochran-Mantel-Haenszel||||
1704690|NCT00922207|3135427|Superiority or Other||Odds Ratio (OR)|0.9||||0.6853|2-Sided|95.0|0.46|1.75|||Cochran-Mantel-Haenszel||||
1704691|NCT00922194|3135428|Superiority or Other||Median Difference (Final Values)|-2.37|||<|0.05||95.0|-2.65|-2.08|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values|
1704692|NCT00922194|3135429|Superiority or Other||Median Difference (Final Values)|-2.97|||<|0.05||95.0|-3.57|-2.38|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values|
1704693|NCT00922194|3135430|Superiority or Other||Median Difference (Final Values)|-4.61|||<|0.05||95.0|-5.2|-3.8|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values|
1704694|NCT00922194|3135431|Superiority or Other||Median Difference (Final Values)|-0.014|||<|0.05||95.0|-0.02|0.001|||Wilcoxon paired sign rank-sum test|||Analysis of difference between 12 months or more and baseline values|
1704695|NCT00922194|3135432|Superiority or Other||Median Difference (Final Values)|-7.41|||<|0.05||95.0|-8.37|-6.47|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months and baseline values|
1704696|NCT00922194|3135433|Superiority or Other||Median Difference (Final Values)|-3.27|||<|0.05||95.0|-3.5|-3.0|||Wilcoxon paired signed rank-sum test|||Analysis of difference between 12 months or more and baseline values|
1704697|NCT00922194|3135434|Superiority or Other||Median Difference (Final Values)|-8.36|Standard Deviation|3.3|<|0.05||95.0|-9.03|-7.72|||Paired t test|||Analysis of difference between 12 months or more and baseline values|
1704698|NCT00921843|3135446|Superiority||||||<|0.05|||||||ANOVA||||
1704699|NCT00921687|3135447|Superiority or Other||Odds Ratio (OR)|1.12||||0.44||95.0|0.84|1.49|||Generalized Estimating Equation||Intervention clinic (vs control clinic)||
1704700|NCT00921687|3135448|Superiority or Other||Odds Ratio (OR)|1.53||||0.04|2-Sided|95.0|1.01|2.3|||Generalized Estimating Equation||Intervention clinic (vs control clinic)||
1704701|NCT00921557|3135467|Superiority or Other||||||>|0.99||||||Not adjusted for multiple comparisons|Fisher Exact|||Comparison of percentage of participants experiencing primary safety outcome|
1704702|NCT00921557|3135468|Superiority or Other||||||<|0.001||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||Comparison of percent change from baseline to week 48|
1704703|NCT00921557|3135468|Superiority or Other||||||<|0.001||||||Not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Comparison of percent change from baseline to week 24|
1704704|NCT00921024|3135481|Superiority or Other||Risk Difference (RD)|-7.1|||||2-Sided||||||||||
1704705|NCT00921024|3135482|Superiority or Other||Risk Difference (RD)|6.8|||||2-Sided||||||||||
1704706|NCT00920907|3135490|Superiority or Other||F-statistic|4.35|||<|0.0001|||||||F-test|numerator 10 degrees freedom, denominator 782 degrees freedom||Overall time effect. Null hypothesis of no mean ALC changes over time in either process group (treatment arm).|
1704760|NCT00918567|3135798|Superiority or Other (legacy)||Mean Difference (Final Values)|3.05|Standard Error of the Mean|1.7|<|0.05|2-Sided|||||Also tested marginal effects (p<.10)|Mixed Models Analysis||||
1704707|NCT00920907|3135490|Superiority or Other||omnibus conditional F-test|0.4|||<|0.85||||||Not corrected for multiple testing|F-test|numerator 5 degrees freedom, denominator 782 degrees freedom||Time-by-process interaction. Null hypothesis that the pattern of mean ALC values over time is the same for both processes.|
1704708|NCT00920907|3135495|Superiority or Other||Ratio of adjusted geometric mean|1.032|||||2-Sided|90.0|0.922|1.156||||||Biocomparability of ipilimumab Process C to ipilimumab Process B was to be concluded if the 90% confidence intervals (CIs) for the ratio of geometric means for ipilimumab Cmax were contained within 80% to 125%. Point estimates and 90% CIs were constructed for the ratio of geometric means (Process C/Process B) for ipilimumab Cmax.|
1704709|NCT00920907|3135499|Superiority or Other||Ratio of adjusted geometric mean|1.01|||||2-Sided|90.0|0.916|1.114||||||Biocomparability of ipilimumab Process C to ipilimumab Process B was concluded if the 90% confidence intervals (CIs) for the ratio of geometric means for Cmax were contained within 80% to 125%.|
1704710|NCT00920829|3135509|Superiority|||||||0.023|||||||Mixed Models Analysis|||This is a test of the main effect of medication, with a null hypothesis of no difference between Naltrexone and Placebo groups.|
1704711|NCT00920829|3135509|Superiority|||||||0.724|||||||Mixed Models Analysis|||A linear mixed model with unstructured variance/covariance matrices was used to evaluate the primary outcome measure.|
1704712|NCT00920816|3135524|Superiority or Other||Hazard Ratio (HR)|0.731|||||2-Sided|95.0|0.506|1.058||||||Second-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1) and prior treatment (sunitinib versus cytokine-containing regimen).|
1704713|NCT00920816|3135525|Superiority or Other||Hazard Ratio (HR)|0.767|||||2-Sided|95.0|0.559|1.053||||||First-line participants: hazard ratio was stratified by eastern cooperative oncology group (ECOG) performance status (0 versus 1).|
1704714|NCT00920686|3135539|Superiority or Other|||||||0.6407|||||||Log Rank||||
1704715|NCT00920426|3135594|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1704716|NCT00920426|3135595|Superiority or Other||Mean Difference (Net)|-1.804|||<|0.001|2-Sided|95.0|-2.173|-1.436||ANCOVA with treatment as fixed effect, and baseline HIV-1 RNA as covariate.|ANCOVA||||
1704717|NCT00920426|3135621|Superiority or Other||Mean Difference (Net)|-2.09|||<|0.001|2-Sided|95.0|-2.547|-1.632||Analysis of covariance (ANCOVA) with treatment as fixed effect, and Baseline HIV-1 RNA as covariate.|ANCOVA||||
1704718|NCT00920218|3135644|Superiority|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (>) 3.|Fold increase over Control|42.2|||<|0.0001|2-Sided|76.16|20.2|88.13|||Dunnett for multiple comparisons|||The null hypothesis was H0: Placebo-GSK 1437173A 1 Group/Placebo Group < 1.|
1704719|NCT00920218|3135644|Superiority|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of humoral response for GSK 1437173A F1 Group as compared to Placebo Group, is above (>) 3.|Fold increase over Control|74.41|||<|0.0001|2-Sided|76.16|33.12|167.17|||Dunnett for multiple comparisons|||The null hypothesis was H0: GSK 1437173A 1 Group/Placebo Group < 1.|
1704720|NCT00920218|3135645|Superiority|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of CMI response for Placebo-GSK 1437173A F1 Group as compared to Placebo Group, is above (>) 2.|Fold increase over Control|9.51|||<|0.0001|2-Sided|76.16|6.07|14.9|||Dunnett for multiple comparisons|||The null hypothesis was H0: Placebo-GSK 1437173A F1 Group/Placebo Group < 2.|
1704721|NCT00920218|3135645|Superiority|Criterion for superiority: The Lower Limit (LL) of the Confidence Interval (CI) of the ratio of geometric means, in terms of ceellular immune (CMI) response for GSK 1437173A F1 Group as compared to Placebo Group, is above (>) 2.|Fold increase over Control|32.31|||<|0.0001|2-Sided|76.16|20.65|50.54|||Dunnett for multiple comparisons|||The null hypothesis was H0: GSK 1437173A F1 Group/Placebo Group below (<) 1.|
1704722|NCT00919893|3135679|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||"Null hypothesis: Cernilton compared to placebo induces a better or the same outcome of symptomatic improvement in the pain domain of symptomatic Pelvic Pain Syndrome verified by the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI).~Power calculation: A power of 1-beta=0.8 was calculated."|
1704723|NCT00919802|3135695|Other|paired t-test comparison of change in VAR from baseline 6 hours after drug; a change in VAR score was calculated for each subject for each arm and compared using a paired t-test||||||0.7252|||||||t-test, 2 sided||||
1704724|NCT00919802|3135696|Other|||||||0.688|||||||t-test, 2 sided|||Global Response Assessment (GRA) scores were obtained 6 and 24 hours post oxytocin or saline administration.|
1704725|NCT00919724|3135699|Superiority or Other||Mean Difference (Final Values)|0.99|Standard Error of the Mean|0.6||0.1||||||Comparison between HIV-infected and HIV-uninfected groups. Comparison adjusted for age, gender, race, height, and brachial artery baseline diameter.|Regression, Linear||||
1704726|NCT00919711|3135700|Superiority or Other||Mean Difference (Net)|2.3|||<|0.0001|2-Sided|95.0|1.8|2.8|||ANCOVA||Denosumab - Risedronate||
1704727|NCT00919711|3135701|Superiority or Other||Mean Difference (Net)|1.4|||<|0.0001|2-Sided|95.0|0.9|1.8|||ANCOVA||Denosumab - Risedronate||
1704728|NCT00919711|3135702|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1704729|NCT00919711|3135703|Superiority or Other||Mean Difference (Net)|1.6|||<|0.0001|2-Sided|95.0|1.2|2.0|||ANCOVA||Denosumab - Risedronate||
1704730|NCT00919126|3135721|Superiority or Other||Mean Difference (Final Values)|0.7351||||0.0365|2-Sided|95.0|0.038|1.432||Pairwise comparison was performed using the Tukey's test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 70% in Oxygen minus Xenon 50% in Oxygen was assessed||
1704731|NCT00919126|3135721|Superiority or Other||Mean Difference (Final Values)|2.2905|||<|0.0001|2-Sided|95.0|1.57|3.011||Pairwise comparison performed using Tukey’s test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 50% in Oxygen minus Medical Air in Oxygen was assessed.||
1704761|NCT00918567|3135799|Superiority or Other (legacy)||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.2|<|0.05|2-Sided|||||Also tested marginal effects (p<.10)|Mixed Models Analysis||||
1704732|NCT00919126|3135721|Superiority or Other||Mean Difference (Final Values)|3.0256|||<|0.0001|2-Sided|95.0|2.328|3.724||Pairwise comparison performed using Tukey’s test.|ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.|The difference Xenon 70% in Oxygen minus Medical Air in Oxygen was assessed.||
1704733|NCT00919126|3135721|Superiority or Other||||||<|0.0001|||||||ANCOVA|The analysis of covariance was adjusted for quantity of propofol (mg) administered during the induction period, gender, type of surgery and centre.||The dose of propofol adjusted to BSA and maintenance duration was expected to be 4.0 mg/m².min in the control group, 2.8 mg/m².min in one xenon group and 3.0 mg/m².min in the other xenon group. With an expected common standard deviation of 2.0 mg/m².min, a type I error of 0.05 (two-sided) and a power of 0.80, the sample size required to show a statistically significant difference between the three groups was estimated to be 48 patients per group, resulting in a total of 144 randomised patients.|
1704734|NCT00918879|3135745|Superiority or Other||Mean Difference (Net)|8.8||||||95.0|-1.7|19.3|||||||
1704735|NCT00918879|3135746|Superiority or Other||Mean Difference (Net)|-0.57|Standard Error of the Mean|0.302||0.0623||95.0|-1.17|0.02|||ANCOVA|* Adjusted for baseline FPG|||
1704736|NCT00918879|3135747|Superiority or Other||Mean Difference (Net)|-10.19|Standard Error of the Mean|5.438||0.0623||95.0|-20.91|0.53|||ANCOVA|* Adjusted for baseline FPG|||
1704737|NCT00918879|3135748|Superiority or Other||Mean Difference (Net)|-0.46|Standard Error of the Mean|0.139||0.0011||95.0|-0.73|-0.18|||ANCOVA|* adjusted for baseline HbA1c|||
1704738|NCT00918749|3135754|Superiority or Other||LS Mean Difference|-2.825|Standard Error of the Mean|4.185||0.5006|2-Sided|90.0|-9.744|4.095|||ANOVA|Fixed effects for treatment and center.|||
1704739|NCT00918749|3135754|Superiority or Other||LS Mean Difference|1.269|Standard Error of the Mean|4.16||0.7606|2-Sided|90.0|-5.609|8.148|||ANOVA|Fixed effects for treatment and center.|||
1704740|NCT00918749|3135755|Superiority or Other||LS Mean Difference|4.926|Standard Error of the Mean|4.371||0.2613|2-Sided|90.0|-2.301|12.153|||ANOVA|Fixed effects for treatment and center.|||
1704741|NCT00918749|3135755|Superiority or Other||LS Mean Difference|4.966|Standard Error of the Mean|4.327||0.2527|2-Sided|90.0|-2.189|12.12|||ANOVA|Fixed effects for treatment and center.|||
1704742|NCT00918749|3135756|Superiority or Other||LS Mean Difference|4.842|Standard Error of the Mean|4.063||0.2349|2-Sided|90.0|-1.874|11.559|||ANOVA|Fixed effects for treatment and center.|||
1704743|NCT00918749|3135756|Superiority or Other||LS Mean Difference|3.108|Standard Error of the Mean|4.052||0.444|2-Sided|90.0|-3.59|9.807|||ANOVA|Fixed effects for treatment and center.|||
1704744|NCT00918749|3135757|Superiority or Other||LS Mean Difference|-0.914|Standard Error of the Mean|9.1||0.9201|2-Sided|90.0|-15.959|14.132|||ANOVA|Fixed effects for treatment and center.|||
1704745|NCT00918749|3135757|Superiority or Other||LS Mean Difference|5.505|Standard Error of the Mean|9.046||0.5436|2-Sided|90.0|-9.452|20.462|||ANOVA|Fixed effects for treatment and center.|||
1704746|NCT00918749|3135758|Superiority or Other||LS Mean Difference|-7.393|Standard Error of the Mean|6.126||0.2291|2-Sided|90.0|-17.522|2.737|||ANOVA|Fixed effects for treatment and center.|||
1704747|NCT00918749|3135758|Superiority or Other||LS Mean Difference|1.119|Standard Error of the Mean|6.093||0.8546|2-Sided|90.0|-8.956|11.193|||ANOVA|Fixed effects for treatment and center.|||
1704748|NCT00918749|3135759|Superiority or Other||LS Mean Difference|14.215|Standard Error of the Mean|9.343||0.1298|2-Sided|90.0|-1.23|29.659|||ANOVA|Fixed effects for treatment and center.|||
1704749|NCT00918749|3135759|Superiority or Other||LS Mean Difference|14.528|Standard Error of the Mean|9.28||0.1192|2-Sided|90.0|-0.813|29.868|||ANOVA|Fixed effects for treatment and center.|||
1704750|NCT00918749|3135760|Superiority or Other||LS Mean Difference|-10.787|Standard Error of the Mean|4.313||0.0133|2-Sided|90.0|-17.917|-3.657|||ANOVA|Fixed effects for treatment and center.|||
1704751|NCT00918749|3135760|Superiority or Other||LS Mean Difference|0.388|Standard Error of the Mean|4.269||0.9276|2-Sided|90.0|-6.67|7.447|||ANOVA|Fixed effects for treatment and center.|||
1704752|NCT00918749|3135761|Superiority or Other||LS Mean Difference|-0.218|Standard Error of the Mean|4.966||0.965|2-Sided|90.0|-8.427|7.991|||ANOVA|Fixed effects for treatment and center.|||
1704753|NCT00918749|3135761|Superiority or Other||LS Mean Difference|4.765|Standard Error of the Mean|4.952||0.3372|2-Sided|90.0|-3.421|12.952|||ANOVA|Fixed effects for treatment and center.|||
1704754|NCT00918749|3135762|Superiority or Other||LS Mean Difference|-12.197|Standard Error of the Mean|4.241||0.0045|2-Sided|90.0|-19.208|-5.185|||ANOVA|Fixed effects for treatment and center.|||
1704755|NCT00918749|3135762|Superiority or Other||LS Mean Difference|-3.598|Standard Error of the Mean|4.215||0.3946|2-Sided|90.0|-10.568|3.372|||ANOVA|Fixed effects for treatment and center.||A two group t-test with a 0.100 one-sided significance level would have 96% power to detect the difference between a risedronate 150 mg IRBB mean, µ1, of -46.000 and a risedronate 75 mg DRFB mean, µ2, of -29.900 (a difference in means of -16.100), assuming that the common SD was 28.000, with sample sizes of 60 per group, respectively. Estimates were based on Study 2005107 (35 mg DR once a week Phase 2 study). The sample size calculation was not adjusted for multiplicity.|
1704756|NCT00918736|3135769|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Previous report using 5 weekly injections, mean AOS score reduction is 2.6 with the SD of 1.8 in 75 patients. To test whether AOS reduction would be > 1 using pair t-test after 3 weekly injections, investigators need > 42 patients to give > 90% power to reject the null hypothesis-mean AOS score reduction <1 at 6 months, given that both the mean and standard deviation of AOS score reduction equal to 2. Considering possible dropout of participants, investigators decide to include 50 patients|
1704757|NCT00918567|3135795|Superiority or Other (legacy)||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.19|<|0.05|2-Sided|||||Also tested marginal effects (p<.10)|Mixed Models Analysis||||
1704758|NCT00918567|3135796|Superiority or Other (legacy)||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.15|<|0.05|2-Sided|||||Also tested marginal effect (p<.10)|Mixed Models Analysis||||
1704759|NCT00918567|3135797|Superiority or Other (legacy)||Mean Difference (Final Values)|0.08|Standard Error of the Mean|1.8|<|0.05|2-Sided|||||Also tested marginal effects (p<.10)|Mixed Models Analysis||||
1704793|NCT00918203|3135848|Superiority or Other||Hazard Ratio (HR)|1.04||||0.8731|2-Sided|95.0|0.68|1.57|||Log Rank||||
1704762|NCT00918567|3135800|Superiority or Other (legacy)||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.18|>|0.05|2-Sided|||||Also tested marginal effects defined as p<.10|Mixed Models Analysis||||
1704763|NCT00918567|3135801|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.07|<|0.05|2-Sided|||||also tested marginal effects defined as p<.10|Mixed Models Analysis||||
1704764|NCT00918567|3135802|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.09|<|0.05|2-Sided|||||Also estimated marginal effects defined as p<.10|Mixed Models Analysis||||
1704765|NCT00918567|3135803|Superiority or Other (legacy)||Mean Difference (Final Values)|0.27|Standard Error of the Mean|0.6|<|0.05|2-Sided|||||Also tested marginal effects defined as p<.10|Mixed Models Analysis||||
1704766|NCT00918567|3135804|Superiority or Other (legacy)||Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.51|<|0.05|2-Sided|||||Also examined marginal effects, defined as p<.10|Mixed Models Analysis||||
1704767|NCT00918567|3135805|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.22|Standard Error of the Mean|1.93|<|0.05|2-Sided|||||Also tested marginal effects defined as p < .10.|Mixed Models Analysis|Tukey-Kramer adjustments for post-hoc differences of least squares comparisons|||
1704768|NCT00918346|3135812|Non-Inferiority or Equivalence|The equivalence limit was set to 1.5 mmHg. Equivalence was shown if the two-sided 95% confidence interval for the difference (unpreserved-preserved) lay entirely within the equivalence range (-1.5 mmHg, 1.5 mmHg). Target sample size was 34 evaluable patients (40 randomized), assuming a standard deviation of 3.0 mmHg change in IOP, a power of 80%, an intra-class correlation coefficient of 0.60 and a twosided type I error rate of 5%.|Median Difference (Final Values)|-0.05||||0.83||95.0|-0.52|0.42|||ANCOVA|Baseline IOP a covariate|Analysis model used IOP measurements at four timepoints (at 8, 12, 16 and 20 o'clock) on Baseline and Week 4|H1 (the alternative hypothesis aimed to be proven): the unpreserved formulation is equivalent with the preserved formulation|
1704769|NCT00918346|3135813|Non-Inferiority or Equivalence|The equivalence limit was set to 1.5 mmHg. Equivalence was shown if the two-sided 95% confidence interval for the difference (unpreserved-preserved) lay entirely within the equivalence range (-1.5 mmHg, 1.5 mmHg). Target sample size was 34 evaluable patients (40 randomized), assuming a standard deviation of 3.0 mmHg change in IOP, a power of 80%, an intra-class correlation coefficient of 0.60 and a twosided type 1 error rate of 5%.|Mean Difference (Final Values)|0.01||||0.96||95.0|-0.46|0.49|||ANCOVA|Baseline IOP a covariate|Analysis model used IOP measurements at four timepoints (at 8, 12, 16 and 20 o'clock) on Baseline and Week 4.|H1 (the alternative hypothesis aimed to be proven): the unpreserved formulation is equivalent with the preserved formulation|
1704770|NCT00918333|3135825|Superiority or Other (legacy)||Maximum Tolerated Dose (mg)|40.0|||||2-Sided||||||||||
1704771|NCT00918255|3135830|Superiority or Other|||||||0.169|||||||Van Elteren test|Analyzed using Van Elteren test stratified by Hurley Stage.|||
1704772|NCT00918255|3135830|Superiority or Other|||||||0.014|||||||Van Elteren test|Analyzed using Van Elteren test stratified by Hurley Stage.|||
1704773|NCT00918255|3135830|Superiority or Other|||||||0.045||||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Van Elteren test||||
1704774|NCT00918255|3135831|Superiority or Other|||||||0.721|||||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.|||
1704775|NCT00918255|3135831|Superiority or Other|||||||0.02|||||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.|||
1704776|NCT00918255|3135831|Superiority or Other|||||||0.012||||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel||||
1704777|NCT00918255|3135832|Superiority or Other|||||||0.673|||||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.|||
1704778|NCT00918255|3135832|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.|||
1704779|NCT00918255|3135832|Superiority or Other|||||||1||||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel||||
1704780|NCT00918255|3135833|Superiority or Other|||||||0.32|||||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.|||
1704781|NCT00918255|3135833|Superiority or Other|||||||0.051|||||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.|||
1704782|NCT00918255|3135833|Superiority or Other|||||||0.044||||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel||||
1704783|NCT00918255|3135834|Superiority or Other|||||||0.097|||||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.|||
1704784|NCT00918255|3135834|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.|||
1704785|NCT00918255|3135834|Superiority or Other|||||||1||||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel||||
1704786|NCT00918255|3135835|Superiority or Other|||||||0.286|||||||ANCOVA|Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).|||
1704787|NCT00918255|3135835|Superiority or Other|||||||0.019|||||||ANCOVA|Analyzed using ANCOVA adjusting for Baseline Hurley Stage (I/II vs III).|||
1704788|NCT00918255|3135835|Superiority or Other|||||||0.062||||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|ANCOVA||||
1704789|NCT00918255|3135836|Superiority or Other|||||||0.252|||||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.|||
1704790|NCT00918255|3135836|Superiority or Other|||||||0.025|||||||Cochran-Mantel-Haenszel|Analyzed using CMH test stratified by Hurley Stage.|||
1704791|NCT00918255|3135836|Superiority or Other|||||||0.022||||||When this initial overall comparison of the 3 treatment groups was significant, pairwise comparisons of each adalimumab dose group versus placebo were performed.|Cochran-Mantel-Haenszel||||
1704792|NCT00918203|3135847|Superiority or Other|||||||0.4721|||||||Fisher Exact||||
1704794|NCT00918203|3135851|Superiority or Other||Hazard Ratio (HR)|1.29||||0.2133|2-Sided|95.0|0.86|1.93|||Log Rank||||
1704795|NCT00918138|3135854|Superiority or Other||Mean Difference (Final Values)|-5.7|Standard Error of the Mean|7.18|||2-Sided|95.0|-20.0|8.5|||||Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg||
1704796|NCT00918138|3135855|Superiority or Other||Mean Difference (Final Values)|-31.1|Standard Error of the Mean|11.8|||2-Sided|95.0|-54.6|-7.7|||||Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg.||
1704797|NCT00918138|3135856|Superiority or Other||Mean Difference (Final Values)|-10.8|Standard Error of the Mean|7.01||0.1278|2-Sided|95.0|-24.8|3.2||Comparison between saxagliptin 5 mg + metformin 1500 mg and metformin 2000 mg significant at alpha =0.05 according to sequential testing procedure|ANCOVA|Change from baseline to week 4 was analyzed with ANCOVA including treatment group, baseline value and country in the model|Estimate = adjusted mean change for saxagliptin 5 mg + metformin 1500 mg - adjusted mean change for metformin 2000 mg|With at least 36 participants per treatment group (72 total), there is 90% power to detect a difference of 18 mg/dL between the two treatment groups. Assuming approximately 20% of participants will discontinue without any valid post-randomization assessment at Week 4, a total of 90 participants (45 participants per treatment group) needed to be randomized.|
1704798|NCT00917644|3135869|Non-Inferiority or Equivalence|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%)|Ratio of adjusted geometric means|104.66||||||90.0|95.73|114.42|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Observed directly from data.|Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals were obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.|
1704799|NCT00917644|3135870|Non-Inferiority or Equivalence|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%). AUCinf method of determination includes AUClast calculated value.|Ratio of adjusted geometric means|98.72||||||90.0|94.41|103.23|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Log-linear trapezoidal method.|Natural log transformed AUClast was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence interval was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.|
1704800|NCT00917644|3135872|Non-Inferiority or Equivalence|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell wholly within (80%, 125%)|Ratio of adjusted geometric means|98.79||||||90.0|94.57|103.2|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Natural log transformed AUCinf was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Adjusted mean difference (Test-Ref) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL <=µT - µR <=θU); null hypothesis of inequivalence: (Ho: µT - µR <θL or µT - µR >θU).|
1704801|NCT00917579|3135875|Non-Inferiority or Equivalence|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell within (80%, 125%).|ratio of adjusted geometric means|91.41||||||90.0|83.39|100.2|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means.|Natural log transformed Cmax was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence intervals were obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.|
1704802|NCT00917579|3135876|Non-Inferiority or Equivalence|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both the AUCinf and Cmax fell within (80%, 125%). AUCinf method of determination includes AUC last calculated value.|ratio of adjusted geometric means|95.79||||||90.0|91.07|100.76|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. Log-linear trapezoidal method.|Natural log transformed AUClast was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Estimates of the adjusted mean differences (Test-Reference) and corresponding 90% confidence interval was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean (Test/Reference) and 90% confidence interval for the ratio.|
1704803|NCT00917579|3135877|Non-Inferiority or Equivalence|Bioequivalence of the two treatments was concluded if the 90% confidence intervals for the ratio of adjusted geometric means for both AUCinf and Cmax fell within (80%, 125%).|ratio of adjusted geometric means|95.34||||||90.0|91.33|99.52|||||Parameter estimate = ratio (%) (test/reference) of adjusted geometric means. AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Natural log transformed AUCinf was analyzed using a mixed effects model with sequence, period and treatment as fixed effects and subject within sequence as a random effect. Adjusted mean difference (Test-Ref) and 90% CI was obtained from the model and exponentiated to provide estimates of the ratio of adjusted geometric mean and 90% CI for the ratio. Alternative hypothesis of bioequivalence: (H1: θL <=µT - µR <=θU); null hypothesis of inequivalence: (Ho: µT - µR <θL or µT - µR >θU).|
1704804|NCT00917384|3135895|Superiority or Other (legacy)||Difference Between Arms|24.2|||<|0.0001|2-Sided|95.0|14.9|33.6|||Normal Approximation||||
1704805|NCT00917384|3135896|Superiority or Other (legacy)||Hazard Ratio (HR)|0.483|||<|0.0001|2-Sided|95.0|0.376|0.62|||Stratified Log-Rank Test|Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).|||
1704806|NCT00917384|3135897|Superiority or Other (legacy)||Hazard Ratio (HR)|0.776||||0.0473||95.0|0.603|0.998|||Stratified Log-Rank Test|Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).|||
1704807|NCT00917267|3135900|Superiority or Other||Geometic Least Squares Mean Ratio|0.99|Standard Error of the Mean|0.03||0.807|2-Sided|95.0|0.93|1.06|||Mixed Models Analysis|||TG data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using a MMRM ANCOVA model with treatment, baseline TG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.|
1704808|NCT00917267|3135901|Superiority or Other||Least Squares Mean Difference|0.37|Standard Error of the Mean|0.52||0.476|2-Sided|95.0|-0.65|1.38|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline HDL, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.|
1704809|NCT00917267|3135902|Superiority or Other||Least Squares Mean Difference|-1.31|Standard Error of the Mean|2.56||0.609|2-Sided|95.0|-6.33|3.71|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline TC, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.|
1704810|NCT00917267|3135903|Superiority or Other||Least Squares Mean Difference|0.82|Standard Error of the Mean|0.22|<|0.001|2-Sided|95.0|0.39|1.25|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline BW, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.|
1704811|NCT00917267|3135904|Superiority or Other||Least Squares Mean Difference|-16.67|Standard Error of the Mean|2.97|<|0.001|2-Sided|95.0|-22.5|-10.83|||Mixed Models Analysis|||MMRM ANCOVA model includes treatment, baseline FSG, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects.|
1704812|NCT00917267|3135905|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c target <=6.5% at Week 26 were compared between treatments using a CMH test, in which country and background OAD served as the stratification factors.|
1704813|NCT00917267|3135906|Superiority or Other|||||||0.003|||||||Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c target <=7% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which country and background OAD served as the stratification factors.|
1704814|NCT00917267|3135907|Non-Inferiority or Equivalence|Superiority of exenatide once weekly to exenatide twice daily concluded if upper limit of the 2-sided 95% confidence interval for treatment difference is <0; noninferiority concluded if upper limit is <0.4%.|Least Squares Mean Difference|-0.31|Standard Error of the Mean|0.09|<|0.001|2-Sided|95.0|-0.49|-0.14|||Mixed Models Analysis|||MMRM analysis of covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD, week of visit, and treatment-by-week interaction as fixed effects; and patient and error as random effects. Power: 306 patients per treatment group provides approximately 98% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.|
1704815|NCT00917124|3135909|Superiority or Other|||||||0.002|||||||Chi-squared, Corrected|||"Hypothesis: intraoperative monitoring of cerebral oxigenation with INVOS system will improve cognitive outcome of patients undergoing CABG procedure.~Sample size was determined assuming 50% incidence of cognitive impairment after cardiac surgery and possibility of decreasing that incidence to 30% using cerebral oximetry. Based on 0.8 power to detect a significant difference (p=0.05), 90 patients were required for each study group."|
1704816|NCT00916929|3135910|Superiority or Other||sensitivity|50.0|Standard Error of the Mean|5.0|||1-Sided|95.0|50.0|||||||"For each patient cohort, the hypothesis is formally expressed as follows:~H0: Sensitivity ≤ 50% Ha: Sensitivity > 50%~The desired outcome was to reject the null hypothesis at the 5% significance level. The null hypothesis is rejected at the 5% significance level if the 95% lower confidence limit (LCL) for sensitivity is greater than 50%."|
1704817|NCT00916929|3135911|Superiority or Other||rate per patient year of follow up|1.5||||||95.0||||||||"For each patient cohort, the hypothesis is formally expressed as follows:~H0: Expected False Positive Rate ≥1.5 per patient-year of follow-up Ha: Expected False Positive Rate <1.5 per patient-year of follow-up~The null hypothesis is rejected at the 5% significance level if the 95% upper confidence limit (UCL) for expected FPR is less than 1.5 per patient-year of follow-up."|
1704818|NCT00916721|3135914|Superiority or Other|||||||0.05|||||||Mixed Models Analysis|Multiple significance testing:we adjusted p-value by controlling the expected proportion of falsely rejected hypotheses:false discovery rate,Benjamini|||
1704819|NCT00916357|3136025|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve [AUC])|
1704820|NCT00916357|3136025|Superiority or Other||||||<|0.72||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve [AUC])|
1704821|NCT00916357|3136025|Superiority or Other||||||<|0.0001||||||Treatment comparison for Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 50% of exposure (area under the curve [AUC])|
1704822|NCT00916357|3136025|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve [AUC])|
1704823|NCT00916357|3136025|Superiority or Other||||||<|0.18||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve [AUC])|
1704824|NCT00916357|3136025|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Analysis for 10% of exposure (area under the curve [AUC])|
1704825|NCT00916357|3136027|Superiority or Other|||||||0.011||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance||||
1704964|NCT00915343|3136227|Superiority or Other||Mean difference|33.532||||0.0396|2-Sided|95.0|1.734|65.329|||Fisher's non-parametric permutation test||||
1704826|NCT00916357|3136027|Superiority or Other|||||||0.88||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704827|NCT00916357|3136027|Superiority or Other|||||||0.016||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704828|NCT00916357|3136028|Superiority or Other|||||||0.46||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) <70 milligrams per deciliter (mg/dL)|
1704829|NCT00916357|3136028|Superiority or Other|||||||0.41||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) <70 milligrams per deciliter (mg/dL)|
1704830|NCT00916357|3136028|Superiority or Other|||||||0.13||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) <70 milligrams per deciliter (mg/dL)|
1704831|NCT00916357|3136028|Superiority or Other|||||||0.02||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) >140 milligrams per deciliter (mg/dL)|
1704832|NCT00916357|3136028|Superiority or Other|||||||0.46||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) >140 milligrams per deciliter (mg/dL)|
1704833|NCT00916357|3136028|Superiority or Other|||||||0.099||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) >140 milligrams per deciliter (mg/dL)|
1704834|NCT00916357|3136028|Superiority or Other|||||||0.012||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) >160 milligrams per deciliter (mg/dL)|
1704835|NCT00916357|3136028|Superiority or Other|||||||0.47||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) >160 milligrams per deciliter (mg/dL)|
1704836|NCT00916357|3136028|Superiority or Other|||||||0.064||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Participants with blood glucose (BG) >160 milligrams per deciliter (mg/dL)|
1704837|NCT00916357|3136029|Superiority or Other|||||||0.0056||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance||||
1704838|NCT00916357|3136029|Superiority or Other|||||||0.82||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704839|NCT00916357|3136029|Superiority or Other|||||||0.01||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704840|NCT00916357|3136030|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance||||
1704841|NCT00916357|3136030|Superiority or Other||||||<|0.77||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704842|NCT00916357|3136030|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704843|NCT00916357|3136031|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance||||
1704844|NCT00916357|3136031|Superiority or Other||||||<|0.3||||||Treatment comparison for Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704845|NCT00916357|3136031|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humalog alone + Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704846|NCT00916357|3136032|Superiority or Other|||||||0.1||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance||||
1704847|NCT00916357|3136032|Superiority or Other|||||||0.0016||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704848|NCT00916357|3136032|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704849|NCT00916357|3136033|Superiority or Other|||||||0.0006||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance||||
1704850|NCT00916357|3136033|Superiority or Other|||||||0.48||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704851|NCT00916357|3136033|Superiority or Other|||||||0.0045||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704852|NCT00916357|3136034|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance||||
1704853|NCT00916357|3136034|Superiority or Other||||||<|0.18||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704854|NCT00916357|3136034|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance||||
1704855|NCT00916357|3136035|Superiority or Other|||||||0.031||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.|
1708383|NCT00858208|3143283|Superiority or Other|||||||0.2759|||||||paired t-test||||
1704856|NCT00916357|3136035|Superiority or Other|||||||0.6||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.|
1704857|NCT00916357|3136035|Superiority or Other|||||||0.095||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||Peak postprandial glucose (PPG) values.|
1704858|NCT00916357|3136035|Superiority or Other|||||||0.015||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.|
1704859|NCT00916357|3136035|Superiority or Other|||||||0.92||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.|
1704860|NCT00916357|3136035|Superiority or Other|||||||0.019||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||120 minutes after study drug injection.|
1704861|NCT00916357|3136035|Superiority or Other|||||||0.0031||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.|
1704862|NCT00916357|3136035|Superiority or Other|||||||0.93||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.|
1704863|NCT00916357|3136035|Superiority or Other|||||||0.0039||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||90 minutes after study drug injection.|
1704864|NCT00916357|3136035|Superiority or Other|||||||0.0001||||||Treatment comparison of Humalog + recombinant human hyaluronidase PH20 (rHuPH20) and Humulin-R + rHuPH20.|Repeated measures Analysis of Variance|||60 minutes after study drug injection.|
1704865|NCT00916357|3136035|Superiority or Other|||||||0.26||||||Treatment comparison of Humalog alone and Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||60 minutes after study drug injection.|
1704866|NCT00916357|3136035|Superiority or Other|||||||0.0034||||||Treatment comparison of Humalog alone and Humalog + recombinant human hyaluronidase PH20 (rHuPH20).|Repeated Measures Analysis of Variance|||60 minutes after study drug injection.|
1704867|NCT00916149|3136045|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the AEP score from pre to post time points in the levetiracetam treatment group|
1704868|NCT00916149|3136045|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the AEP score from pre to post time points in the no treatment group|
1704869|NCT00916149|3136046|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the NDDIE score from pre to post time points in the levetiracetam treatment group|
1704870|NCT00916149|3136046|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the NDDIE score from pre to post time points in the no treatment group|
1704871|NCT00916149|3136047|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the levetiracetam treatment group|
1704872|NCT00916149|3136047|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Reaction Time from pre to post time points in the no treatment group|
1704873|NCT00916149|3136048|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the levetiracetam treatment group|
1704874|NCT00916149|3136048|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Facial Recognition Accuracy score from pre to post time points in the no treatment group|
1704875|NCT00916149|3136049|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the levetiracetam treatment group|
1704876|NCT00916149|3136049|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Reaction Time from pre to post time points in the no treatment group|
1704877|NCT00916149|3136050|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the levetiracetam treatment group|
1704878|NCT00916149|3136050|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Recognition Accuracy score from pre to post time points in the no treatment group|
1704879|NCT00916149|3136051|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment group|
1704880|NCT00916149|3136051|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Reaction Time from pre to post time points in the no treatment group|
1704881|NCT00916149|3136052|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment group|
1704882|NCT00916149|3136052|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Non-verbal Working Memory Accuracy score from pre to post time points in the no treatment group|
1704883|NCT00916149|3136053|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the levetiracetam treatment group|
1704884|NCT00916149|3136053|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Reaction Time from pre to post time points in the no treatment group|
1704885|NCT00916149|3136054|Other|||||||0.039|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the levetiracetam treatment group|
1704886|NCT00916149|3136054|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Working Memory Accuracy score from pre to post time points in the no treatment group|
1708384|NCT00858208|3143284|Superiority or Other|||||||0.7625|||||||paired t-test|||Change at Month 24|
1704887|NCT00916149|3136055|Other|||||||0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Choice Reaction Time score from pre to post time points in the no treatment group|
1704888|NCT00916149|3136056|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Choice Accuracy score from pre to post time points in the no treatment group|
1704889|NCT00916149|3136057|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT reaction time from pre to post time points in the levetiracetam treatment group|
1704890|NCT00916149|3136057|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT reaction time from pre to post time points in the no treatment group|
1704891|NCT00916149|3136058|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT Accuracy score from pre to post time points in the levetiracetam treatment group|
1704892|NCT00916149|3136058|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CPT Accuracy score from pre to post time points in the no treatment group|
1704893|NCT00916149|3136059|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Symbol score from pre to post time points in the levetiracetam treatment group|
1704894|NCT00916149|3136059|Other||||||>|0.014|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Symbol score from pre to post time points in the no treatment group|
1704895|NCT00916149|3136060|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the levetiracetam treatment group|
1704896|NCT00916149|3136060|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Grooved Pegboard task from pre to post time points in the no treatment group|
1704897|NCT00916149|3136061|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Trails Test from pre to post time points in the levetiracetam treatment group|
1704898|NCT00916149|3136061|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in performance on the Trails Test from pre to post time points in the no treatment group|
1704899|NCT00916149|3136062|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Design Fluency score from pre to post time points in the levetiracetam treatment group|
1704900|NCT00916149|3136062|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Design Fluency score from pre to post time points in the no treatment group|
1704901|NCT00916149|3136063|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in Stroop performance from pre to post time points in the levetiracetam treatment group|
1704902|NCT00916149|3136063|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in Stroop performance from pre to post time points in the no treatment group|
1704903|NCT00916149|3136064|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Fluency score from pre to post time points in the levetiracetam treatment group|
1704904|NCT00916149|3136064|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Verbal Fluency score from pre to post time points in the no treatment group|
1704905|NCT00916149|3136065|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Span score from pre to post time points in the levetiracetam treatment group|
1704906|NCT00916149|3136065|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Digit Span score from pre to post time points in the no treatment group|
1704907|NCT00916149|3136066|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Spatial Span score from pre to post time points in the levetiracetam treatment group|
1704908|NCT00916149|3136066|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Spatial Span score from pre to post time points in the no treatment group|
1704909|NCT00916149|3136067|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the levetiracetam treatment group|
1704910|NCT00916149|3136067|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the Letter Number Sequencing score from pre to post time points in the no treatment group|
1704911|NCT00916149|3136068|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the QOLIE score from pre to post time points in the levetiracetam treatment group|
1704912|NCT00916149|3136069|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the levetiracetam treatment group|
1704913|NCT00916149|3136069|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Delayed Recall score from pre to post time points in the no treatment group|
1704914|NCT00916149|3136070|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the levetiracetam treatment group|
1704915|NCT00916149|3136070|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Total Learning score from pre to post time points in the no treatment group|
1704916|NCT00916149|3136071|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the levetiracetam treatment group.|
1704917|NCT00916149|3136071|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the BVMT-R Learning score from pre to post time points in the no treatment group.|
1704918|NCT00916149|3136072|Other|||||||0.045|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the levetiracetam treatment group.|
1704919|NCT00916149|3136072|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Long Delay score from pre to post time points in the no treatment group.|
1704920|NCT00916149|3136073|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the levetiracetam treatment group.|
1704921|NCT00916149|3136073|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Short Delay score from pre to post time points in the no treatment group.|
1704922|NCT00916149|3136074|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the levetiracetam treatment group.|
1704923|NCT00916149|3136074|Other||||||>|0.016|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Total Learning Score from pre to post time points in the no treatment group.|
1704924|NCT00916149|3136075|Other||||||>|0.05|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the levetiracetam group.|
1704925|NCT00916149|3136075|Other||||||>|0.005|||||||Wilcoxon Signed Ranks Test|||This analysis assessed the change in the CVLT Trial 1 Learning Score from pre to post time points in the no treatment group.|
1704926|NCT00916149|3136076|Other||||||>|0.05||||||For each group (levetiracetam and no treatment), the change in IEDs/hour from pre to post-intervention: p >0.05. The a priori threshold for statistical significance was p=0.05.|Wilcoxon Signed Ranks Test|||Change in frequency of IEDs/per hour was assessed for each group (levetiracetam and no treatment)|
1704927|NCT00916032|3136101|Superiority or Other|||||||0.162|||||||paired t-test done on the Log(AUC 0-48h)||||
1704928|NCT00916032|3136102|Superiority or Other|||||||0.103|||||||paired t-test done on the Log(AUC 0-48h)||||
1704929|NCT00916006|3136103|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1704930|NCT00916006|3136104|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1704931|NCT00915876|3136111|Superiority or Other||||||>|0.05|||||||ANOVA||||
1704932|NCT00915798|3136114|Superiority or Other||F|0.16||||0.69|2-Sided||||||ANOVA|Threshold for statistical significance p < 0.05||Occipital BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.|
1704933|NCT00915798|3136114|Superiority or Other||F|0.43||||0.51|2-Sided||||||ANOVA|Threshold for statistical significance p < 0.05||Parietal BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.|
1704934|NCT00915798|3136114|Superiority or Other||F|1.6||||0.22|2-Sided||||||ANOVA|Threshold for statistical significance p < 0.05||Frontal BOLD smoking versus nonsmoking in smokers with ADHD compared to control smokers.|
1704935|NCT00915798|3136114|Superiority or Other||F|211.2||||0.04|2-Sided||||||ANOVA|Threshold for statistical significance p < 0.05|Main effect for smoking status.|Occipital BOLD during abstinence in smokers and nonsmokers.|
1704936|NCT00915798|3136114|Superiority or Other||F|6.64||||0.012|2-Sided||||||ANOVA|Threshold for statistical significance p < 0.05|Diagnosis by smoking status interaction.|Parietal BOLD during abstinence in smokers and nonsmokers|
1704937|NCT00915798|3136114|Superiority or Other||F|0.56||||0.46|2-Sided||||||ANOVA|Threshold for statistical significance p < 0.05||Frontal BOLD during abstinence in smokers and nonsmokers|
1704938|NCT00915551|3136150|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1704939|NCT00915551|3136151|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1704940|NCT00915473|3136196|Superiority or Other|||||||0.47|||||||t-test, 2 sided||||
1704941|NCT00915473|3136197|Superiority or Other|||||||0.9|||||||t-test, 2 sided||||
1704942|NCT00915473|3136198|Superiority or Other|||||||0.47|||||||t-test, 2 sided|||At Least Mild Migraine Frequency|
1704943|NCT00915473|3136198|Superiority or Other|||||||0.52|||||||t-test, 2 sided|||At least Moderate Migraine Frequency|
1704944|NCT00915473|3136198|Superiority or Other|||||||0.52|||||||t-test, 2 sided|||Severe Migraine Frequency|
1704945|NCT00915473|3136199|Superiority or Other|||||||0.98|||||||Chi-squared||||
1704946|NCT00915343|3136212|Superiority or Other||Mean difference|-272.3||||0.0034|2-Sided||||||Wilcoxon Signed Rank test||||
1704947|NCT00915343|3136213|Superiority or Other||||||<|0.0001|||||||Sign test||||
1704948|NCT00915343|3136215|Superiority or Other||Mean difference|1.28|||||2-Sided||||||||||
1704949|NCT00915343|3136216|Superiority or Other|||||||0.2624|||||||Wilcoxon Signed Rank test||||
1704950|NCT00915343|3136217|Superiority or Other|||||||0.97|||||||Wilcoxon Signed Rank test||||
1704951|NCT00915343|3136218|Superiority or Other|||||||0.8676|||||||Wilcoxon Signed Rank test||||
1704952|NCT00915343|3136219|Superiority or Other||Mean difference|2.3||||0.0632|2-Sided||||||Fisher’s test|Fisher’s non-parametric two-sample permutation test|||
1704953|NCT00915343|3136220|Superiority or Other|||||||0.5982|||||||Wilcoxon Signed Rank test||||
1704954|NCT00915343|3136221|Superiority or Other||Mean difference|-2.9||||0.0823|2-Sided||||||Fisher’s|Fisher’s non-parametric two-sample permutation test|||
1704955|NCT00915343|3136222|Superiority or Other|||||||0.355|||||||Wilcoxon Signed Rank test|||Change From Baseline to 6 months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Mental Component Score|
1704956|NCT00915343|3136222|Superiority or Other|||||||0.8418|||||||Wilcoxon Signed Rank|||Change From Baseline to 6 months in Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical Component Score|
1704957|NCT00915343|3136223|Superiority or Other||Mean difference|0.9||||0.3405|2-Sided||||||Fisher’s test|Fisher’s non-parametric two-sample permutation test||Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Mental Component Score|
1704958|NCT00915343|3136223|Superiority or Other||Mean difference|-0.6||||0.3332|2-Sided||||||Fisher’s test|Fisher’s non-parametric two-sample permutation test||Comparison of Quality of Life (QoL) Assessed by Short Form-36 Survey (SF-36) For Physical Component Score|
1704959|NCT00915343|3136224|Superiority or Other|||||||1|||||||Sign test|||Investigator|
1704960|NCT00915343|3136224|Superiority or Other|||||||0.6072|||||||Sign test|||Patient|
1704961|NCT00915343|3136225|Superiority or Other||least square mean|-0.064||||0.4625|2-Sided|95.0|-0.235|0.107|||Fisher’s test|Fisher’s non||Investigator|
1704962|NCT00915343|3136225|Superiority or Other||least square mean|-0.078||||0.3767|2-Sided|95.0|-0.25|0.094|||Fisher’s test|Fisher’s non||Patient|
1704963|NCT00915343|3136226|Superiority or Other||Period-adjusted quotient|0.08||||0.1032|2-Sided|95.0|-0.017|0.177|||Fisher's non-parametric permutation test||||
1708385|NCT00858208|3143284|Superiority or Other|||||||0.0573|||||||paired t-test|||Change at Month 18|
1704965|NCT00915343|3136228|Superiority or Other||Period-adjusted quotient|6.098|||<|0.0001|2-Sided|95.0|2.94|12.646|||ANOVA||The quotient was defined as AUC Extrapolation for OD treatment divided by AUC Extrapolation for TID treatment.||
1704966|NCT00915343|3136229|Superiority or Other||Mean difference|-0.001||||0.0015|2-Sided|95.0|-0.001|0.0|||Fisher's non-parametric permutation test||||
1704967|NCT00915343|3136230|Superiority or Other||Mean difference|-0.055||||0.7827|2-Sided|95.0|-0.444|0.334|||Fisher's non-parametric permutation test||||
1704968|NCT00915343|3136231|Superiority or Other||Mean difference|-0.001|||<|0.0001|2-Sided|95.0|-0.002|-0.001|||Fisher's non-parametric permutation test||||
1704969|NCT00915343|3136232|Superiority or Other||Mean difference|-0.001|||<|0.0001|2-Sided|95.0|-0.001|0.0|||Fisher's non-parametric permutation test||||
1704970|NCT00915343|3136233|Superiority or Other||Period-adjusted quotient|1.053||||0.002|2-Sided|95.0|1.02|1.086|||ANOVA||The quotient was defined as AUC0-4h/dose for OD treatment divided by AUC0-4h/dose for TID treatment.||
1704971|NCT00915343|3136234|Superiority or Other||Period-adjusted quotient|0.885|||<|0.0001|2-Sided|95.0|0.844|0.926|||ANOVA||The quotient was defined as AUC0-10h/dose for OD treatment divided by AUC0-10h/dose for TID treatment.||
1704972|NCT00915343|3136235|Superiority or Other||Period-adjusted quotient|0.785|||<|0.0001|2-Sided|95.0|0.741|0.831|||ANOVA||The quotient was defined as AUC0-24h/dose for OD treatment divided by AUC0-24h/dose for TID treatment.||
1704973|NCT00915343|3136236|Superiority or Other||Period-adjusted quotient|0.79|||<|0.0001|2-Sided|95.0|0.734|0.851|||ANOVA||The quotient was defined as AUCtau/dose for OD treatment divided by AUCtau/dose for TID treatment.||
1704974|NCT00915343|3136237|Superiority or Other||Period-adjusted quotient|0.806|||<|0.0001|2-Sided|95.0|0.753|0.862|||ANOVA||The quotient was defined as AUCtau for OD treatment divided by AUCtau for TID treatment.||
1704975|NCT00915343|3136238|Superiority or Other||Period-adjusted quotient|1.069||||0.877|2-Sided|95.0|0.453|2.521|||ANOVA||The quotient was defined as AUC(24h-inf) for OD treatment divided by AUC(24h-inf) for TID treatment.|AUC(24h-inf)|
1704976|NCT00915343|3136238|Superiority or Other||Period-adjusted quotient|0.776|||<|0.0001|2-Sided|95.0|0.714|0.843|||ANOVA||The quotient was defined as AUC(0-inf) for OD treatment divided by AUC(0-inf) for TID treatment.|AUC(0-inf)|
1704977|NCT00915343|3136238|Superiority or Other||Period-adjusted quotient|0.412|||<|0.0001|2-Sided|95.0|0.338|0.504|||ANOVA||The quotient was defined as AUC10-24h for OD treatment divided by AUC10-24h for TID treatment.|AUC10-24h|
1704978|NCT00915343|3136238|Superiority or Other||Period-adjusted quotient|0.54|||<|0.0001|2-Sided|95.0|0.482|0.605|||ANOVA||The quotient was defined as AUC6-10h for OD treatment divided by AUC6-10h for TID treatment.|AUC6-10h|
1704979|NCT00915343|3136238|Superiority or Other||Period-adjusted quotient|0.695|||<|0.0001|2-Sided|95.0|0.632|0.765|||ANOVA||The quotient was defined as AUC4-10h for OD treatment divided by AUC4-10h for TID treatment.|AUC4-10h|
1704980|NCT00915343|3136238|Superiority or Other||Period-adjusted quotient|0.894|||<|0.0001|2-Sided|95.0|0.856|0.935|||ANOVA||The quotient was defined as AUC0-10h for OD treatment divided by AUC0-10h for TID treatment.|AUC0-10h|
1704981|NCT00915343|3136238|Superiority or Other||Period-adjusted quotient|0.588|||<|0.0003|2-Sided|95.0|0.446|0.775|||ANOVA||The quotient was defined as AUC12-24h for OD treatment divided by AUC12-24h for TID treatment.|AUC12-24h|
1704982|NCT00915343|3136238|Superiority or Other||Period-adjusted quotient|0.472|||<|0.0001|2-Sided|95.0|0.424|0.525|||ANOVA||The quotient was defined as AUC6-12h for OD treatment divided by AUC6-12h for TID treatment.|AUC6-12h|
1704983|NCT00915343|3136238|Superiority or Other||Period-adjusted quotient|0.617|||<|0.0001|2-Sided|95.0|0.563|0.675|||ANOVA||The quotient was defined as AUC4-12h for OD treatment divided by AUC4-12h for TID treatment.|AUC4-12h|
1704984|NCT00915343|3136238|Superiority or Other||Period-adjusted quotient|1.064|||<|0.0002|2-Sided|95.0|1.032|1.097|||ANOVA||The quotient was defined as AUC0-4h for OD treatment divided by AUC0-4h for TID treatment.|AUC0-4h|
1704985|NCT00915343|3136239|Superiority or Other||Mean difference|-13.8|||<|0.0001|2-Sided|95.0|-20.533|-7.067|||Fisher's non-parametric permutation test||||
1704986|NCT00915343|3136240|Superiority or Other||Mean difference|5.509||||0.0003|2-Sided|95.0|0.751|10.268|||Fisher's non-parametric permutation test||||
1704987|NCT00915343|3136241|Superiority or Other||Mean difference|0.049||||0.028|2-Sided|95.0|0.006|0.093|||Fisher's non-parametric permutation test||||
1704988|NCT00915343|3136242|Superiority or Other||Mean difference|-0.007||||0.6687|2-Sided|95.0|-0.038|0.024|||Fisher's non-parametric permutation test||||
1704989|NCT00915343|3136243|Superiority or Other||Mean difference|-1.042||||0.0714|2-Sided|95.0|-2.098|0.015|||Fisher's non-parametric permutation test||||
1704990|NCT00915343|3136244|Superiority or Other||Mean difference|0.27||||0.0214|2-Sided|95.0|0.028|0.512|||Fisher's non-parametric permutation test||||
1704991|NCT00915343|3136245|Superiority or Other||Mean difference|-108.306|||<|0.0001|2-Sided|95.0|-140.193|-76.42|||Fisher's non-parametric permutation test||||
1704992|NCT00915343|3136246|Superiority or Other||Mean difference|-148.015|||<|0.0001|2-Sided|95.0|-189.469|-106.561|||Fisher's non-parametric permutation test||||
1704993|NCT00915343|3136247|Superiority or Other||Mean difference|-65.782||||0.0033|2-Sided|95.0|-109.201|22.362|||Fisher's non-parametric permutation test||||
1704994|NCT00915343|3136248|Superiority or Other||Mean difference|-38.076|||<|0.0001|2-Sided|95.0|-50.276|25.876|||Fisher's non-parametric permutation test||||
1704995|NCT00915343|3136249|Superiority or Other||Mean difference|110.417||||0.0357|2-Sided|95.0|16.755|204.078|||Fisher's non-parametric permutation test||||
1704996|NCT00915343|3136250|Superiority or Other||Mean difference|-111.989|||<|0.0001|2-Sided|95.0|-133.98|89.999|||Fisher's non-parametric permutation test||||
1704997|NCT00915343|3136251|Superiority or Other||Period-adjusted quotient|0.806|||<|0.0001|2-Sided|95.0|0.753|0.862||Comparison of log S-cortisol AUC between OD and TID regimens was adjusted for both period effect and subject effect using generalized linear model (GLM) in statistical analysis system (SAS).|ANOVA||The quotient was defined as AUC0-24h for OD treatment divided by AUC0-24h for TID treatment.||
1705033|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.15|||<|0.001|2-Sided|95.0|2.09|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours|
1705034|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.64|||<|0.001|2-Sided|95.0|1.61|3.67||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours|
1704998|NCT00915148|3136275|Superiority or Other||||||<|0.01||||||the reported p-value corresponds with each log rank comparison|Log Rank|||"Kaplan Meier plots were used to compare time from a defined prolonged labor in the first stage to delivery for~women with fetal head-perineum distance ≤40 mm vs. women with distance >40 mm measured with 2D ultrasound.~women with angle of progression ≥110 degrees vs. women with angle <110 degrees measured with 2D ultrasound"|
1704999|NCT00915148|3136276|Superiority or Other||||||<|0.01||||||The reported p-value corresponds with each area under the ROC assessments|Chi-squared|||In a previous study we investigated women before induction of labor. Using 40 mm as cut-off level for fetal head – perineum distance, the Cesarean section rate in primiparous women was 7% in the group with a short distance and 27% in the group with a long distance. We assumed similar results, with alpha 0.05, power 0.8 and a ratio of 1 : 1 for the numbers of women with a long and short distance. We would need to include 110 women in the study.|
1705000|NCT00915018|3136278|Other||Hazard Ratio (HR)|0.449||||0.0036|2-Sided|95.0|0.259|0.78|||Log Rank||||
1705001|NCT00915018|3136279|Other||Risk Difference (RD)|-0.032||||0.236|2-Sided|95.0|-0.093|0.029|||Mantel Haenszel||||
1705002|NCT00915018|3136280|Other||Hazard Ratio (HR)|0.974||||0.8431|2-Sided|95.0|0.752|1.262|||Log Rank||||
1705003|NCT00915018|3136281|Other||Risk Difference (RD)|0.028||||0.5219|2-Sided|95.0|-0.048|0.105|||Mantel Haenszel||||
1705004|NCT00915018|3136282|Superiority||Hazard Ratio (HR)|1.015||||0.8934|2-Sided|95.0|0.813|1.269|||Log Rank||||
1705005|NCT00914810|3136320|Superiority or Other||Mean Difference (Net)|10.5|||<|0.0001|2-Sided|95.0|7.4|13.6|||t-test, 2 sided||||
1705006|NCT00914810|3136321|Superiority or Other||Mean Difference (Net)|0.3||||0.55|2-Sided|95.0|-0.8|1.5|||t-test, 2 sided||||
1705007|NCT00914589|3136326|Superiority or Other||Odds Ratio (OR)|0.9871||||0.9634||95.0|0.5673|1.7176||P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1705008|NCT00914589|3136326|Superiority or Other||Odds Ratio (OR)|1.0482||||0.8648||95.0|0.6095|1.8029||P values less than 0.05 are considered statistically significant in this study.|Regression, Logistic||||
1705009|NCT00914485|3136327|Superiority or Other|||||||0.03|||||||t-test, 1 sided|||Increase in mean, post-intervention versus baseline, across 18 providers and 369 patients.|
1705010|NCT00914069|3136358|Superiority or Other|||||||0.8|||||||Fisher Exact||||
1705011|NCT00914069|3136361|Superiority or Other|||||||0.05||||||Threshold for significance was p less than or equal to 0.05 by a one-tailed Fisher Exact Test.|Fisher Exact||||
1705012|NCT00913835|3136378|Superiority or Other (legacy)|||||||0.619|||||||Fisher Exact||||
1705013|NCT00913835|3136379|Superiority or Other (legacy)||Hazard Ratio (HR)|1.115||||0.6346|2-Sided|90.0|0.768|1.618|||Log Rank|Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.|||
1705014|NCT00913835|3136380|Superiority or Other (legacy)||Hazard Ratio (HR)|1.054||||0.8049|2-Sided|90.0|0.751|1.478|||Log Rank|Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.|||
1705015|NCT00913744|3136383|Superiority or Other||Difference in proportions|12.3||||0.262|2-Sided|95.0|-3.7|28.4|||Fisher Exact|P-value is from Fisher's exact test, comparing sham and ocriplasmin.|||
1705016|NCT00913627|3136389|Superiority or Other||Mean Difference (Final Values)|2.05|||<|0.001|2-Sided|95.0|1.58|2.52||p-value adjusted for baseline PSR and gender|ANOVA||||
1705017|NCT00913627|3136389|Superiority or Other||Mean Difference (Final Values)|2.39|||<|0.001|2-Sided|95.0|1.92|2.86||p-value adjusted for baseline PSR and gender|ANOVA||||
1705018|NCT00913627|3136389|Superiority or Other||Mean Difference (Final Values)|2.42|||<|0.001|2-Sided|95.0|1.94|2.89||p-value adjusted for baseline PSR and gender|ANOVA||||
1705019|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.19|||<|0.001|2-Sided|95.0|1.05|3.34||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours|
1705020|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|1.9|||<|0.001|2-Sided|95.0|0.75|3.05||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours|
1705021|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.02|||<|0.001|2-Sided|95.0|0.86|3.19||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours|
1705022|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.36|||<|0.001|2-Sided|95.0|1.25|3.47||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours|
1705023|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.45|||<|0.001|2-Sided|95.0|1.33|3.56||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours|
1705024|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.64|||<|0.001|2-Sided|95.0|1.51|3.76||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours|
1705025|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.26|||<|0.001|2-Sided|95.0|1.14|3.37||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours|
1705026|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.74|||<|0.001|2-Sided|95.0|1.62|3.85||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours|
1705027|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.7|||<|0.001|2-Sided|95.0|1.57|3.83||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours|
1705028|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.35|||<|0.001|2-Sided|95.0|1.28|3.42||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours|
1705029|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.99|||<|0.001|2-Sided|95.0|1.91|4.07||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours|
1705030|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.03|||<|0.001|2-Sided|95.0|1.94|4.12||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours|
1705031|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.4|||<|0.001|2-Sided|95.0|1.36|3.44||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours|
1705032|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.41|||<|0.001|2-Sided|95.0|2.36|4.46||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours|
1705576|NCT00910910|3136769|Superiority||Odds Ratio (OR)|0.66||||0.047|2-Sided|95.0|0.45|0.98|||Fisher Exact||||
1705035|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.57|||<|0.001|2-Sided|95.0|2.53|4.61||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours|
1705036|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.1|||<|0.001|2-Sided|95.0|2.06|4.15||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours|
1705037|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.59|||<|0.001|2-Sided|95.0|1.58|3.6||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours|
1705038|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.65|||<|0.001|2-Sided|95.0|2.64|4.66||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours|
1705039|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.19|||<|0.001|2-Sided|95.0|2.17|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours|
1705040|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.49|||<|0.001|2-Sided|95.0|1.49|3.48||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours|
1705041|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.51|||<|0.001|2-Sided|95.0|2.51|4.51||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours|
1705042|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.2|||<|0.001|2-Sided|95.0|2.19|4.21||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours|
1705043|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.67|||<|0.001|2-Sided|95.0|1.69|3.65||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours|
1705044|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.51|||<|0.001|2-Sided|95.0|2.52|4.49||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours|
1705045|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.54|||<|0.001|2-Sided|95.0|2.54|4.53||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours|
1705046|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.6|||<|0.001|2-Sided|95.0|1.65|3.54||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours|
1705047|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.84|||<|0.001|2-Sided|95.0|2.89|4.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours|
1705048|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.61|||<|0.001|2-Sided|95.0|2.65|4.56||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours|
1705049|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.8|||<|0.001|2-Sided|95.0|1.85|3.75||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours|
1705050|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.93|||<|0.001|2-Sided|95.0|2.98|4.89||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours|
1705051|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.75|||<|0.001|2-Sided|95.0|2.78|4.71||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours|
1705052|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.83|||<|0.001|2-Sided|95.0|1.91|3.75||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours|
1705053|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|4.0|||<|0.001|2-Sided|95.0|3.07|4.92||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours|
1705054|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|4.07|||<|0.001|2-Sided|95.0|3.14|5.01||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours|
1705055|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.98|||<|0.001|2-Sided|95.0|2.11|3.85||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours|
1705056|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|4.04|||<|0.001|2-Sided|95.0|3.17|4.92||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours|
1705057|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|4.25|||<|0.001|2-Sided|95.0|3.36|5.13||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours|
1705058|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.09|||<|0.001|2-Sided|95.0|2.24|3.93||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours|
1705059|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|4.09|||<|0.001|2-Sided|95.0|3.24|4.95||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours|
1705060|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|4.13|||<|0.001|2-Sided|95.0|3.27|4.99||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours|
1705061|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.72|||<|0.001|2-Sided|95.0|1.87|3.57||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours|
1705062|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.68|||<|0.001|2-Sided|95.0|2.82|4.53||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours|
1705063|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.57|||<|0.001|2-Sided|95.0|2.7|4.44||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours|
1705064|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.77|||<|0.001|2-Sided|95.0|1.92|3.63||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes|
1705065|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.42|||<|0.001|2-Sided|95.0|2.57|4.28||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes|
1705066|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|3.26|||<|0.001|2-Sided|95.0|2.39|4.12||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes|
1705067|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.16|||<|0.001|2-Sided|95.0|1.32|3.0||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes|
1705068|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.66|||<|0.001|2-Sided|95.0|1.81|3.51||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes|
1705069|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.64|||<|0.001|2-Sided|95.0|1.78|3.5||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes|
1705577|NCT00910910|3136770|Superiority||Odds Ratio (OR)|0.65||||0.032|2-Sided|95.0|0.44|0.96|||Fisher Exact||||
1705070|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|1.52|||<|0.001|2-Sided|95.0|0.74|2.31||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes|
1705071|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.03|||<|0.001|2-Sided|95.0|1.24|2.82||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes|
1705072|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|2.26|||<|0.001|2-Sided|95.0|1.46|3.06||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes|
1705073|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|1.01|||<|0.002|2-Sided|95.0|0.38|1.63||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes|
1705074|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|1.08|||<|0.001|2-Sided|95.0|0.45|1.71||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes|
1705075|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|1.32|||<|0.001|2-Sided|95.0|0.69|1.96||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes|
1705076|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|0.39|||<|0.048|2-Sided|95.0|0.0|0.78||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes|
1705077|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|0.44|||<|0.028|2-Sided|95.0|0.05|0.83||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes|
1705078|NCT00913627|3136390|Superiority or Other||Mean Difference (Final Values)|0.52|||<|0.011|2-Sided|95.0|0.12|0.91||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes|
1705079|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.32|||<|0.001|2-Sided|95.0|0.61|2.02||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours|
1705080|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.08|||<|0.003|2-Sided|95.0|0.38|1.79||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours|
1705081|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.25|||<|0.001|2-Sided|95.0|0.53|1.96||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours|
1705082|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.4|||<|0.001|2-Sided|95.0|0.72|2.08||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours|
1705083|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.42|||<|0.001|2-Sided|95.0|0.73|2.1||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours|
1705084|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.58|||<|0.001|2-Sided|95.0|0.88|2.27||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours|
1705085|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.38|||<|0.001|2-Sided|95.0|0.71|2.06||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours|
1705086|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.61|||<|0.001|2-Sided|95.0|0.94|2.29||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours|
1705087|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.64|||<|0.001|2-Sided|95.0|0.95|2.32||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours|
1705088|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.42|||<|0.001|2-Sided|95.0|0.78|2.07||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours|
1705089|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.78|||<|0.001|2-Sided|95.0|1.13|2.43||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours|
1705090|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.83|||<|0.001|2-Sided|95.0|1.17|2.49||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours|
1705091|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.44|||<|0.001|2-Sided|95.0|0.81|2.07||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours|
1705092|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.03|||<|0.001|2-Sided|95.0|1.39|2.66||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours|
1705093|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.9|||<|0.001|2-Sided|95.0|1.26|2.54||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours|
1705094|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.59|||<|0.001|2-Sided|95.0|0.98|2.2||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours|
1705095|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.13|||<|0.001|2-Sided|95.0|1.52|2.75||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours|
1705096|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.9|||<|0.001|2-Sided|95.0|1.28|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours|
1705097|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.56|||<|0.001|2-Sided|95.0|0.97|2.16||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours|
1705098|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.19|||<|0.001|2-Sided|95.0|1.59|2.79||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours|
1705099|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.94|||<|0.001|2-Sided|95.0|1.34|2.55||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours|
1705100|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.51|||<|0.001|2-Sided|95.0|0.91|2.11||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours|
1705101|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.12|||<|0.001|2-Sided|95.0|1.52|2.72||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours|
1705102|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.91|||<|0.001|2-Sided|95.0|1.3|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours|
1705103|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.63|||<|0.001|2-Sided|95.0|1.04|2.21||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours|
1705104|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.12|||<|0.001|2-Sided|95.0|1.53|2.7||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours|
1705499|NCT00910962|3136739|Superiority||Mean Difference (Final Values)|-0.23||||0.023|2-Sided|95.0|-0.44|-0.03|||Repeated measures ANCOVA||||
1705105|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.19|||<|0.001|2-Sided|95.0|1.59|2.78||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours|
1705106|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.57|||<|0.001|2-Sided|95.0|1.02|2.13||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours|
1705107|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.3|||<|0.001|2-Sided|95.0|1.74|2.85||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours|
1705108|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.22|||<|0.001|2-Sided|95.0|1.66|2.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours|
1705109|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.67|||<|0.001|2-Sided|95.0|1.11|2.23||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours|
1705110|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.37|||<|0.001|2-Sided|95.0|1.8|2.93||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours|
1705111|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.26|||<|0.001|2-Sided|95.0|1.69|2.83||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours|
1705112|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.71|||<|0.001|2-Sided|95.0|1.16|2.25||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours|
1705113|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.41|||<|0.001|2-Sided|95.0|1.87|2.96||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours|
1705114|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.47|||<|0.001|2-Sided|95.0|1.92|3.03||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours|
1705115|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.81|||<|0.001|2-Sided|95.0|1.29|2.33||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours|
1705116|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.45|||<|0.001|2-Sided|95.0|1.92|2.97||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours|
1705117|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.54|||<|0.001|2-Sided|95.0|2.01|3.07||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours|
1705118|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.88|||<|0.001|2-Sided|95.0|1.37|2.38||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours|
1705119|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.48|||<|0.001|2-Sided|95.0|1.97|2.99||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours|
1705120|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.5|||<|0.001|2-Sided|95.0|1.98|3.01||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours|
1705121|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.69|||<|0.001|2-Sided|95.0|1.18|2.21||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours|
1705122|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.22|||<|0.001|2-Sided|95.0|1.7|2.74||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours|
1705123|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.12|||<|0.001|2-Sided|95.0|1.59|2.64||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours|
1705124|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.68|||<|0.001|2-Sided|95.0|1.16|2.2||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes|
1705125|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|2.09|||<|0.001|2-Sided|95.0|1.57|2.61||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes|
1705126|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.99|||<|0.001|2-Sided|95.0|1.46|2.52||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes|
1705127|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.26|||<|0.001|2-Sided|95.0|0.75|1.78||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes|
1705128|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.57|||<|0.001|2-Sided|95.0|1.05|2.09||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes|
1705129|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.63|||<|0.001|2-Sided|95.0|1.11|2.16||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes|
1705130|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|0.9|||<|0.001|2-Sided|95.0|0.41|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes|
1705131|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.24|||<|0.001|2-Sided|95.0|0.75|1.74||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes|
1705132|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|1.41|||<|0.001|2-Sided|95.0|0.91|1.91||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes|
1705133|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|0.59|||<|0.004|2-Sided|95.0|0.19|0.98||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes|
1705134|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|0.61|||<|0.003|2-Sided|95.0|0.22|1.01||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes|
1705135|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|0.81|||<|0.001|2-Sided|95.0|0.41|1.22||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes|
1705136|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|0.21|||<|0.125|2-Sided|95.0|-0.06|0.48||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes|
1705137|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|0.22|||<|0.111|2-Sided|95.0|-0.05|0.49||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes|
1705138|NCT00913627|3136391|Superiority or Other||Mean Difference (Final Values)|0.29|||<|0.034|2-Sided|95.0|0.02|0.57||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes|
1705139|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.88|||<|0.001|2-Sided|95.0|0.42|1.33||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours|
1705867|NCT00906074|3137455|Superiority or Other|||||||1|||||||Chi-squared|Chi-squared Pearson||Immunosuppression/Corticosteroids|
1705140|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.82|||<|0.001|2-Sided|95.0|0.36|1.28||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours|
1705141|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.77|||<|0.001|2-Sided|95.0|0.31|1.24||p-value adjusted for baseline PSR and gender|ANOVA|||24 hours|
1705142|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.96|||<|0.001|2-Sided|95.0|0.52|1.4||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours|
1705143|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.03|||<|0.001|2-Sided|95.0|0.58|1.48||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours|
1705144|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.06|||<|0.001|2-Sided|95.0|0.61|1.51||p-value adjusted for baseline PSR and gender|ANOVA|||16 hours|
1705145|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.87|||<|0.001|2-Sided|95.0|0.42|1.33||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours|
1705146|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.12|||<|0.001|2-Sided|95.0|0.66|1.58||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours|
1705147|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.07|||<|0.001|2-Sided|95.0|0.6|1.53||p-value adjusted for baseline PSR and gender|ANOVA|||14 hours|
1705148|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.93|||<|0.001|2-Sided|95.0|0.49|1.36||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours|
1705149|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.21|||<|0.001|2-Sided|95.0|0.77|1.65||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours|
1705150|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.2|||<|0.001|2-Sided|95.0|0.75|1.64||p-value adjusted for baseline PSR and gender|ANOVA|||13 hours|
1705151|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.96|||<|0.001|2-Sided|95.0|0.53|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours|
1705152|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.39|||<|0.001|2-Sided|95.0|0.96|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours|
1705153|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.25|||<|0.001|2-Sided|95.0|0.81|1.68||p-value adjusted for baseline PSR and gender|ANOVA|||12 hours|
1705154|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.04|||<|0.001|2-Sided|95.0|0.61|1.48||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours|
1705155|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.44|||<|0.001|2-Sided|95.0|1.0|1.87||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours|
1705156|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.21|||<|0.001|2-Sided|95.0|0.77|1.64||p-value adjusted for baseline PSR and gender|ANOVA|||11 hours|
1705157|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.03|||<|0.001|2-Sided|95.0|0.6|1.45||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours|
1705158|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.46|||<|0.001|2-Sided|95.0|1.03|1.89||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours|
1705159|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.25|||<|0.001|2-Sided|95.0|0.82|1.68||p-value adjusted for baseline PSR and gender|ANOVA|||10 hours|
1705160|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.98|||<|0.001|2-Sided|95.0|0.56|1.39||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours|
1705161|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.39|||<|0.001|2-Sided|95.0|0.97|1.81||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours|
1705162|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.29|||<|0.001|2-Sided|95.0|0.87|1.71||p-value adjusted for baseline PSR and gender|ANOVA|||9 hours|
1705163|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.04|||<|0.001|2-Sided|95.0|0.63|1.46||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours|
1705164|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.39|||<|0.001|2-Sided|95.0|0.97|1.81||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours|
1705165|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.35|||<|0.001|2-Sided|95.0|0.93|1.77||p-value adjusted for baseline PSR and gender|ANOVA|||8 hours|
1705166|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.02|||<|0.001|2-Sided|95.0|0.62|1.43||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours|
1705167|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.55|||<|0.001|2-Sided|95.0|1.14|1.95||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours|
1705168|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.38|||<|0.001|2-Sided|95.0|0.97|1.79||p-value adjusted for baseline PSR and gender|ANOVA|||7 hours|
1705169|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.13|||<|0.001|2-Sided|95.0|0.72|1.53||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours|
1705170|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.56|||<|0.001|2-Sided|95.0|1.16|1.97||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours|
1705171|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.49|||<|0.001|2-Sided|95.0|1.08|1.9||p-value adjusted for baseline PSR and gender|ANOVA|||6 hours|
1705172|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.12|||<|0.001|2-Sided|95.0|0.73|1.52||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours|
1705173|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.58|||<|0.001|2-Sided|95.0|1.19|1.98||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours|
1705174|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.6|||<|0.001|2-Sided|95.0|1.2|2.0||p-value adjusted for baseline PSR and gender|ANOVA|||5 hours|
1705175|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.17|||<|0.001|2-Sided|95.0|0.81|1.54||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours|
1705176|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.6|||<|0.001|2-Sided|95.0|1.23|1.97||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours|
1705177|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.71|||<|0.001|2-Sided|95.0|1.33|2.08||p-value adjusted for baseline PSR and gender|ANOVA|||4 hours|
1705178|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.21|||<|0.001|2-Sided|95.0|0.85|1.57||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours|
1705179|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.61|||<|0.001|2-Sided|95.0|1.25|1.98||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours|
1705180|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.63|||<|0.001|2-Sided|95.0|1.26|2.0||p-value adjusted for baseline PSR and gender|ANOVA|||3 hours|
1705181|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.03|||<|0.001|2-Sided|95.0|0.67|1.38||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours|
1705182|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.46|||<|0.001|2-Sided|95.0|1.1|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours|
1705183|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.45|||<|0.001|2-Sided|95.0|1.09|1.82||p-value adjusted for baseline PSR and gender|ANOVA|||2 hours|
1705184|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.1|||<|0.001|2-Sided|95.0|0.74|1.45||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes|
1705185|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.33|||<|0.001|2-Sided|95.0|0.97|1.69||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes|
1705186|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.26|||<|0.001|2-Sided|95.0|0.9|1.63||p-value adjusted for baseline PSR and gender|ANOVA|||90 minutes|
1705187|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.9|||<|0.001|2-Sided|95.0|0.54|1.25||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes|
1705188|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.09|||<|0.001|2-Sided|95.0|0.73|1.44||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes|
1705189|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|1.01|||<|0.001|2-Sided|95.0|0.65|1.37||p-value adjusted for baseline PSR and gender|ANOVA|||60 minutes|
1705190|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.62|||<|0.001|2-Sided|95.0|0.3|0.94||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes|
1705191|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.79|||<|0.001|2-Sided|95.0|0.47|1.11||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes|
1705192|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.85|||<|0.001|2-Sided|95.0|0.52|1.17||p-value adjusted for baseline PSR and gender|ANOVA|||45 minutes|
1705193|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.42|||<|0.002|2-Sided|95.0|0.16|0.68||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes|
1705194|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.47|||<|0.001|2-Sided|95.0|0.2|0.73||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes|
1705195|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.51|||<|0.001|2-Sided|95.0|0.24|0.78||p-value adjusted for baseline PSR and gender|ANOVA|||30 minutes|
1705196|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.18|||<|0.024|2-Sided|95.0|0.02|0.34||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes|
1705197|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.22|||<|0.007|2-Sided|95.0|0.06|0.38||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes|
1705198|NCT00913627|3136392|Superiority or Other||Mean Difference (Final Values)|0.22|||<|0.008|2-Sided|95.0|0.06|0.38||p-value adjusted for baseline PSR and gender|ANOVA|||15 minutes|
1705199|NCT00913627|3136393|Superiority or Other||Goodman-Kruskal Gamma Statistic|0.89|||<|0.001|2-Sided|95.0|0.79|0.99||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||||
1705200|NCT00913627|3136393|Superiority or Other||Goodman-Kruskal Gamma Statistic|0.96|||<|0.001|2-Sided|95.0|0.91|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||||
1705201|NCT00913627|3136393|Superiority or Other||Goodman-Kruskal Gamma Statistic|0.93|||<|0.001|2-Sided|95.0|0.85|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||||
1705202|NCT00913627|3136394|Superiority or Other||Goodman-Kruskal Gamma Statistic|0.84|||<|0.001|2-Sided|95.0|0.7|0.98||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||||
1705203|NCT00913627|3136394|Superiority or Other||Goodman-Kruskal Gamma Statistic|0.95|||<|0.001|2-Sided|95.0|0.88|1.02||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||||
1705204|NCT00913627|3136394|Superiority or Other||Goodman-Kruskal Gamma Statistic|0.93|||<|0.001|2-Sided|95.0|0.85|1.01||p-value from CMH test with modified ridit scores, adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||||
1705205|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|58.86|||<|0.001|2-Sided|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes|
1705206|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|77.82|||<|0.001|2-Sided|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes|
1705207|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|69.33|||<|0.001|2-Sided|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes|
1705208|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|58.84|||<|0.001|2-Sided|95.0|42.34|75.35||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes|
1705209|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|81.2|||<|0.001|2-Sided|95.0|67.91|94.49||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes|
1705210|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|72.66|||<|0.001|2-Sided|95.0|57.48|87.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes|
1705211|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|57.03|||<|0.001|2-Sided|95.0|40.46|73.6||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes|
1705212|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|79.36|||<|0.001|2-Sided|95.0|65.68|93.05||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes|
1705213|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|72.66|||<|0.001|2-Sided|95.0|57.48|87.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes|
1705214|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|53.47|||<|0.001|2-Sided|95.0|36.57|70.37||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes|
1705215|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|72.16|||<|0.001|2-Sided|95.0|57.05|87.26||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes|
1705216|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|68.59|||<|0.001|2-Sided|95.0|52.81|84.38||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes|
1705217|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|50.19|||<|0.001|2-Sided|95.0|34.27|66.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes|
1705218|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|64.8|||<|0.001|2-Sided|95.0|50.01|79.59||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes|
1705219|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|64.78|||<|0.001|2-Sided|95.0|49.37|80.18||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes|
1705220|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|46.74|||<|0.001|2-Sided|95.0|31.89|61.58||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes|
1705221|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|53.83|||<|0.001|2-Sided|95.0|38.85|68.8||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes|
1705222|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|61.01|||<|0.001|2-Sided|95.0|46.12|75.89||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes|
1705223|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|27.87|||<|0.003|2-Sided|95.0|13.93|41.81||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes|
1705224|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|36.01|||<|0.001|2-Sided|95.0|21.24|50.78||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes|
1705225|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|47.72|||<|0.001|2-Sided|95.0|32.25|63.19||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes|
1705226|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|10.62|||<|0.129|2-Sided|95.0|-0.68|21.92||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes|
1705227|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|25.31|||<|0.007|2-Sided|95.0|11.35|39.28||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes|
1705228|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|24.58|||<|0.008|2-Sided|95.0|10.68|38.47||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes|
1705229|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|3.59|||<|0.303|2-Sided|95.0|-1.39|8.57||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes|
1705230|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|10.73|||<|0.069|2-Sided|95.0|2.54|18.91||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes|
1705231|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|9.13|||<|0.101|2-Sided|95.0|1.33|16.93||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes|
1705232|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|1.78|||<|0.469|2-Sided|95.0|-1.71|5.27||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes|
1705233|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|0.0|||<||2-Sided|95.0|0.0|0.0||||||15 minutes|
1705234|NCT00913627|3136395|Superiority or Other||CMH adjusted proportions|2.03|||<|0.434|2-Sided|95.0|-1.95|6.02||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes|
1705235|NCT00913627|3136396|Superiority or Other||Hazard Ratio, log|13.56|||<|0.001|2-Sided|95.0|4.85|37.89||p-value adjusted for gender and categorical baseline pain severity|Proportional hazards regression||||
1705236|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|58.86|||<|0.001|2-Sided|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes|
1705237|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|77.82|||<|0.001|2-Sided|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes|
1705238|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|69.33|||<|0.001|2-Sided|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||360 minutes|
1705239|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|58.86|||<|0.001|2-Sided|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes|
1705240|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|77.82|||<|0.001|2-Sided|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes|
1705241|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|69.33|||<|0.001|2-Sided|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||300 minutes|
1705242|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|58.86|||<|0.001|2-Sided|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes|
1705243|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|77.82|||<|0.001|2-Sided|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes|
1705500|NCT00910962|3136740|Superiority||Mean Difference (Final Values)|-14.67||||0.243|2-Sided|95.0|-39.52|10.18|||Repeated measures ANCOVA||||
1705244|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|69.33|||<|0.001|2-Sided|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||240 minutes|
1705245|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|58.86|||<|0.001|2-Sided|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes|
1705246|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|77.82|||<|0.001|2-Sided|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes|
1705247|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|69.33|||<|0.001|2-Sided|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||180 minutes|
1705248|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|58.86|||<|0.001|2-Sided|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes|
1705249|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|77.82|||<|0.001|2-Sided|95.0|63.57|92.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes|
1705250|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|69.33|||<|0.001|2-Sided|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||120 minutes|
1705251|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|58.86|||<|0.001|2-Sided|95.0|41.88|75.84||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes|
1705252|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|74.21|||<|0.001|2-Sided|95.0|59.29|89.14||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes|
1705253|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|69.33|||<|0.001|2-Sided|95.0|53.33|85.33||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||90 minutes|
1705254|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|51.85|||<|0.001|2-Sided|95.0|34.32|69.38||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes|
1705255|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|70.61|||<|0.001|2-Sided|95.0|55.16|86.05||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes|
1705256|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|67.64|||<|0.001|2-Sided|95.0|51.36|83.93||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||60 minutes|
1705257|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|50.2|||<|0.001|2-Sided|95.0|34.2|66.21||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes|
1705258|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|66.67|||<|0.001|2-Sided|95.0|51.56|81.78||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes|
1705259|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|57.39|||<|0.001|2-Sided|95.0|41.2|73.57||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||45 minutes|
1705260|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|36.8|||<|0.001|2-Sided|95.0|22.62|50.98||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes|
1705261|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|51.94|||<|0.001|2-Sided|95.0|37.15|66.73||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes|
1705262|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|48.65|||<|0.001|2-Sided|95.0|33.34|63.96||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||30 minutes|
1705263|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|5.39|||<|0.354|2-Sided|95.0|-4.62|15.4||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes|
1705264|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|16.39|||<|0.043|2-Sided|95.0|3.73|29.04||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes|
1705265|NCT00913627|3136397|Superiority or Other||CMH adjusted proportions|13.31|||<|0.08|2-Sided|95.0|1.26|25.36||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||15 minutes|
1705266|NCT00913627|3136398|Superiority or Other||Mean Difference (Final Values)|18.78|||<|0.001|2-Sided|95.0|13.19|24.38||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12|
1705267|NCT00913627|3136398|Superiority or Other||Mean Difference (Final Values)|25.66|||<|0.001|2-Sided|95.0|20.03|31.28||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12|
1705268|NCT00913627|3136398|Superiority or Other||Mean Difference (Final Values)|24.93|||<|0.001|2-Sided|95.0|19.24|30.61||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-12|
1705269|NCT00913627|3136398|Superiority or Other||Mean Difference (Final Values)|7.73|||<|0.001|2-Sided|95.0|4.87|10.59||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12|
1705270|NCT00913627|3136398|Superiority or Other||Mean Difference (Final Values)|10.59|||<|0.001|2-Sided|95.0|7.71|13.46||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12|
1705271|NCT00913627|3136398|Superiority or Other||Mean Difference (Final Values)|9.84|||<|0.001|2-Sided|95.0|6.93|12.75||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 8-12|
1705272|NCT00913627|3136398|Superiority or Other||Mean Difference (Final Values)|8.38|||<|0.001|2-Sided|95.0|5.76|11.0||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8|
1705273|NCT00913627|3136398|Superiority or Other||Mean Difference (Final Values)|11.64|||<|0.001|2-Sided|95.0|9.01|14.27||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8|
1705274|NCT00913627|3136398|Superiority or Other||Mean Difference (Final Values)|11.68|||<|0.001|2-Sided|95.0|9.02|14.34||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 4-8|
1705275|NCT00913627|3136398|Superiority or Other||Mean Difference (Final Values)|6.11|||<|0.001|2-Sided|95.0|4.46|7.75||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4|
1705276|NCT00913627|3136398|Superiority or Other||Mean Difference (Final Values)|7.99|||<|0.001|2-Sided|95.0|6.34|9.65||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4|
1705277|NCT00913627|3136398|Superiority or Other||Mean Difference (Final Values)|8.13|||<|0.001|2-Sided|95.0|6.45|9.8||p-value adjusted for baseline PSR and gender|ANOVA|||TOTPAR 0-4|
1705278|NCT00913627|3136399|Superiority or Other||Mean Difference (Final Values)|31.08|||<|0.001|2-Sided|95.0|21.63|40.53||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12|
1705279|NCT00913627|3136399|Superiority or Other||Mean Difference (Final Values)|42.66|||<|0.001|2-Sided|95.0|33.15|52.17||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12|
1705280|NCT00913627|3136399|Superiority or Other||Mean Difference (Final Values)|41.08|||<|0.001|2-Sided|95.0|31.48|50.69||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-12|
1705281|NCT00913627|3136399|Superiority or Other||Mean Difference (Final Values)|12.78|||<|0.001|2-Sided|95.0|7.97|17.59||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12|
1705282|NCT00913627|3136399|Superiority or Other||Mean Difference (Final Values)|17.65|||<|0.001|2-Sided|95.0|12.81|22.49||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12|
1705283|NCT00913627|3136399|Superiority or Other||Mean Difference (Final Values)|16.18|||<|0.001|2-Sided|95.0|11.29|21.07||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 8-12|
1705284|NCT00913627|3136399|Superiority or Other||Mean Difference (Final Values)|13.87|||<|0.001|2-Sided|95.0|9.44|18.3||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8|
1705285|NCT00913627|3136399|Superiority or Other||Mean Difference (Final Values)|19.32|||<|0.001|2-Sided|95.0|14.86|23.78||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8|
1705286|NCT00913627|3136399|Superiority or Other||Mean Difference (Final Values)|19.21|||<|0.001|2-Sided|95.0|14.71|23.71||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 4-8|
1705287|NCT00913627|3136399|Superiority or Other||Mean Difference (Final Values)|10.08|||<|0.001|2-Sided|95.0|7.33|12.83||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4|
1705288|NCT00913627|3136399|Superiority or Other||Mean Difference (Final Values)|13.24|||<|0.001|2-Sided|95.0|10.48|16.01||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4|
1705289|NCT00913627|3136399|Superiority or Other||Mean Difference (Final Values)|13.47|||<|0.001|2-Sided|95.0|10.68|16.27||p-value adjusted for baseline PSR and gender|ANOVA|||SPRID 0-4|
1705290|NCT00913627|3136400|Superiority or Other||Mean Difference (Final Values)|5.49|||<|0.001|2-Sided|95.0|3.62|7.36||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8|
1705291|NCT00913627|3136400|Superiority or Other||Mean Difference (Final Values)|7.68|||<|0.001|2-Sided|95.0|5.8|9.56||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8|
1705292|NCT00913627|3136400|Superiority or Other||Mean Difference (Final Values)|7.53|||<|0.001|2-Sided|95.0|5.63|9.43||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 4-8|
1705293|NCT00913627|3136400|Superiority or Other||Mean Difference (Final Values)|3.98|||<|0.001|2-Sided|95.0|2.83|5.12||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 0-4|
1705294|NCT00913627|3136400|Superiority or Other||Mean Difference (Final Values)|5.25|||<|0.001|2-Sided|95.0|4.09|6.4||p-value adjusted for baseline PSR and gender|ANOVA|||SPID 0-4|
1705295|NCT00913627|3136400|Superiority or Other||Mean Difference (Final Values)|5.34|||<|0.001|2-Sided|95.0|4.18|6.51||p-value adjusted for baseline PSR, and gender|ANOVA|||SPID 0-4|
1705296|NCT00913627|3136401|Superiority or Other||CMH adjusted proportions|-50.77|||<|0.001|2-Sided|95.0|-69.09|-32.45||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours|
1705297|NCT00913627|3136401|Superiority or Other||CMH adjusted proportions|-65.28|||<|0.001|2-Sided|95.0|-82.49|-48.07||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours|
1705298|NCT00913627|3136401|Superiority or Other||CMH adjusted proportions|-63.44|||<|0.001|2-Sided|95.0|-80.82|-46.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||12 hours|
1705299|NCT00913627|3136401|Superiority or Other||CMH adjusted proportions|-55.98|||<|0.001|2-Sided|95.0|-73.85|-38.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours|
1705300|NCT00913627|3136401|Superiority or Other||CMH adjusted proportions|-68.88|||<|0.001|2-Sided|95.0|-85.63|-54.14||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours|
1705301|NCT00913627|3136401|Superiority or Other||CMH adjusted proportions|-63.44|||<|0.001|2-Sided|95.0|-80.82|-46.06||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel|||11 hours|
1705302|NCT00913627|3136401|Superiority or Other||Cochran-Mantel-Haenszel (CMH)|-55.98|||<|0.001|2-Sided|95.0|-73.85|-38.11||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours|
1705303|NCT00913627|3136401|Superiority or Other||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|2-Sided|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours|
1705304|NCT00913627|3136401|Superiority or Other||Cochran-Mantel-Haenszel (CMH)|-66.79|||<|0.001|2-Sided|95.0|-83.98|-49.6||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|10 hours|
1705305|NCT00913627|3136401|Superiority or Other||Cochran-Mantel-Haenszel (CMH)|-57.79|||<|0.001|2-Sided|95.0|-75.43|-40.16||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours|
1705306|NCT00913627|3136401|Superiority or Other||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|2-Sided|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours|
1705307|NCT00913627|3136401|Superiority or Other||Cochran-Mantel-Haenszel (CMH)|-72.19|||<|0.001|2-Sided|95.0|-88.56|-55.83||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|9 hours|
1705308|NCT00913627|3136401|Superiority or Other||Cochran-Mantel-Haenszel (CMH)|-59.6|||<|0.001|2-Sided|95.0|-76.94|-42.27||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours|
1705309|NCT00913627|3136401|Superiority or Other||Cochran-Mantel-Haenszel (CMH)|-70.72|||<|0.001|2-Sided|95.0|-87.14|-54.3||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours|
1705310|NCT00913627|3136401|Superiority or Other||Cochran-Mantel-Haenszel (CMH)|-72.19|||<|0.001|2-Sided|95.0|-88.56|-55.83||p-value adjusted for baseline PSR and gender|Cochran-Mantel-Haenszel||CMH adjusted proportions|8 hours|
1705311|NCT00913627|3136404|Superiority or Other||Mean Difference (Final Values)|5.05|||<|0.001|2-Sided|95.0|3.04|7.06||p-value adjusted for baseline PSR and gender|ANOVA||||
1705312|NCT00913627|3136404|Superiority or Other||Mean Difference (Final Values)|7.06|||<|0.001|2-Sided|95.0|5.05|9.08||p-value adjusted for baseline PSR and gender|ANOVA||||
1705313|NCT00913627|3136404|Superiority or Other||Mean Difference (Final Values)|6.34|||<|0.001|2-Sided|95.0|4.3|8.38||p-value adjusted for baseline PSR and gender|ANOVA||||
1705314|NCT00913627|3136405|Superiority or Other||Mean Difference (Final Values)|12.3|||<|0.001|2-Sided|95.0|8.33|16.26||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA||||
1705315|NCT00913627|3136405|Superiority or Other||Mean Difference (Final Values)|17.0|||<|0.001|2-Sided|95.0|13.02|20.99||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA||||
1705316|NCT00913627|3136405|Superiority or Other||Mean Difference (Final Values)|16.16|||<|0.001|2-Sided|95.0|12.13|20.19||p-value adjusted for baseline pain severity rating (PSR) and gender|ANOVA||||
1705317|NCT00913510|3136412|Superiority or Other||Mean Difference (Net)|2.0||||1||||||The p-value is calculated to the fourth decimal place.|Wilcoxon (Mann-Whitney)|||"H0 : µt = µc versus H1 : µt ≠ µc µt = Exp. relative change of frequency of micturitions per day in test group µc = Exp. relative change of frequency of micturitions per day in control group.~Plan was to have 44 evaluable subjects (90% power) but power of the study was reduced by early termination. It cannot be concluded that there is no difference between the treatment groups due to insufficient power."|
1705318|NCT00913458|3136413|Superiority or Other||Mean Difference (Final Values)|-10.51||||0.0161|2-Sided|95.0|-19.0|-2.0|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705319|NCT00913458|3136413|Superiority or Other||Mean Difference (Final Values)|-19.62|||<|0.0001|2-Sided|95.0|-28.1|-11.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705320|NCT00913458|3136413|Superiority or Other||Mean Difference (Final Values)|-9.11|||<|0.0256|2-Sided|95.0|-17.1|-1.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705321|NCT00913458|3136415|Superiority or Other||Mean Difference (Final Values)|-12.56||||0.0713|2-Sided|95.0|-26.2|1.1|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705322|NCT00913458|3136415|Superiority or Other||Mean Difference (Final Values)|-16.57||||0.021|2-Sided|95.0|-30.6|-2.6|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705323|NCT00913458|3136415|Superiority or Other||Mean Difference (Final Values)|-4.01||||0.4664|2-Sided|95.0|-15.0|6.9|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705324|NCT00913458|3136417|Superiority or Other||Mean Difference (Final Values)|-9.85||||0.0621|2-Sided|95.0|-20.2|0.5|||Longitudinal statistical model|||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705325|NCT00913458|3136417|Superiority or Other||Mean Difference (Final Values)|-16.59||||0.0024|2-Sided|95.0|-27.1|-6.0|||Longitudinal statisitical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705326|NCT00913458|3136417|Superiority or Other||Mean Difference (Final Values)|-6.74||||0.1303|2-Sided|95.0|-15.5|2.0|||Longitudinal statistical model|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705327|NCT00913458|3136419|Superiority or Other||Mean Difference (Final Values)|-2.99||||0.6628|2-Sided|95.0|-16.6|10.6|||ANCOVA|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705328|NCT00913458|3136419|Superiority or Other||Mean Difference (Final Values)|-2.55||||0.713|2-Sided|95.0|-16.4|11.2|||ANCOVA|Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705329|NCT00913458|3136419|Superiority or Other||Mean Difference (Final Values)|0.44||||0.9338|2-Sided|95.0|-10.0|10.9|||ANCOVA||Values are based on a model with factors for Week 52 value, treatment, visit, and interaction of treatment and Week 52 value and treatment and visit.|Change from Week 52 to Week 91. The hyothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705330|NCT00913458|3136421|Superiority or Other||Mean Difference (Final Values)|-0.48||||0.2131|2-Sided|95.0|-1.0|0.0|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705331|NCT00913458|3136421|Superiority or Other||Mean Difference (Final Values)|-0.49||||0.2168|2-Sided|95.0|-1.0|0.0|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705370|NCT00913458|3136438|Superiority or Other||||||<|0.0001|||||||Paired t-test|||"Significance tests were based on paired t‑tests using a 2‑sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"|
1708386|NCT00858208|3143284|Superiority or Other|||||||0.1392|||||||paired t-test|||Change at Month 12|
1705332|NCT00913458|3136421|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.9652|2-Sided|95.0|-0.5|0.4|||ANCOVA|P-values for between-treatment comparisons are based on ANCOVA on ranks of change in score with ranks of Week 52 value as covariate.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705333|NCT00913458|3136423|Superiority or Other||Odds Ratio (OR)|1.84||||0.2141|2-Sided|95.0|0.7|4.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705334|NCT00913458|3136423|Superiority or Other||Odds Ratio (OR)|2.77||||0.0551|2-Sided|95.0|1.0|7.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705335|NCT00913458|3136423|Superiority or Other||Odds Ratio (OR)|1.51||||0.4717|2-Sided|95.0|0.5|4.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705336|NCT00913458|3136424|Superiority or Other||Mean Difference (Final Values)|-8.63||||0.0306|2-Sided|95.0|-16.4|-0.8|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705337|NCT00913458|3136424|Superiority or Other||Mean Difference (Final Values)|-14.14||||0.0004|2-Sided|95.0|-21.8|-6.5|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705338|NCT00913458|3136424|Superiority or Other||Mean Difference (Final Values)|-5.51||||0.1248|2-Sided|95.0|-12.6|1.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705339|NCT00913458|3136425|Superiority or Other||Mean Difference (Final Values)|-8.83||||0.0348|2-Sided|95.0|-17.0|-0.6|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705340|NCT00913458|3136425|Superiority or Other||Mean Difference (Final Values)|-13.19||||0.0016|2-Sided|95.0|-21.3|-5.1|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705341|NCT00913458|3136425|Superiority or Other||Mean Difference (Final Values)|-4.36||||0.2473|2-Sided|95.0|-11.8|3.1|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705342|NCT00913458|3136426|Superiority or Other||Mean Difference (Final Values)|-12.98||||0.0035|2-Sided|95.0|-21.5|-4.5|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705343|NCT00913458|3136426|Superiority or Other||Mean Difference (Final Values)|-21.64|||<|0.0001|2-Sided|95.0|-30.1|-13.2|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705344|NCT00913458|3136426|Superiority or Other||Mean Difference (Final Values)|-8.66|||<|0.0328|2-Sided|95.0|-16.6|-0.7|||Longitudinal statistical model|Values are based on a longitudinal statistical model with factors for Week 52 value, treatment, visit, and interaction of treatment.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705345|NCT00913458|3136427|Superiority or Other||Odds Ratio (OR)|3.42||||0.0111|2-Sided|95.0|1.3|8.8|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705346|NCT00913458|3136427|Superiority or Other||Odds Ratio (OR)|11.05|||<|0.0001|2-Sided|95.0|4.4|28.0|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705347|NCT00913458|3136427|Superiority or Other||Odds Ratio (OR)|3.23|||<|0.0017|2-Sided|95.0|1.6|6.7|||Regression, Logistic|Odds ratios, p-values, and 95% CIs are based on a logistic regression model with treatment as the only factor.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705348|NCT00913458|3136428|Superiority or Other||Odds Ratio (OR)|1.61||||0.3619|2-Sided|95.0|0.6|4.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705349|NCT00913458|3136428|Superiority or Other||Odds Ratio (OR)|12.18||||0.0166|2-Sided|95.0|1.6|94.2|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705371|NCT00913458|3136439|Superiority or Other||||||<|0.0001|||||||Paired t-test|||"Significance tests were based on paired t‑tests using a 2‑sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"|
1705350|NCT00913458|3136428|Superiority or Other||Odds Ratio (OR)|7.56||||0.0548|2-Sided|95.0|1.0|59.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705351|NCT00913458|3136429|Superiority or Other||Odds Ratio (OR)|2.1||||0.0676|2-Sided|95.0|0.9|4.7|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705352|NCT00913458|3136429|Superiority or Other||Odds Ratio (OR)|4.57||||0.0007|2-Sided|95.0|1.9|11.0|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705353|NCT00913458|3136429|Superiority or Other||Odds Ratio (OR)|2.17||||0.0788|2-Sided|95.0|0.9|5.2|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705354|NCT00913458|3136430|Superiority or Other||Odds Ratio (OR)|1.5||||0.3696|2-Sided|95.0|0.6|3.6|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705355|NCT00913458|3136430|Superiority or Other||Odds Ratio (OR)|3.22||||0.0064|2-Sided|95.0|1.4|7.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705356|NCT00913458|3136430|Superiority or Other||Odds Ratio (OR)|2.15||||0.0535|2-Sided|95.0|1.0|4.7|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705357|NCT00913458|3136431|Superiority or Other||Odds Ratio (OR)|1.91||||0.1189|2-Sided|95.0|0.8|4.3|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705358|NCT00913458|3136431|Superiority or Other||Odds Ratio (OR)|2.36||||0.0432|2-Sided|95.0|1.0|5.4|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705359|NCT00913458|3136431|Superiority or Other||Odds Ratio (OR)|1.23||||0.6152|2-Sided|95.0|0.5|2.8|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705360|NCT00913458|3136432|Superiority or Other||Odds Ratio (OR)|2.85||||0.0314|2-Sided|95.0|1.1|7.4|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705361|NCT00913458|3136432|Superiority or Other||Odds Ratio (OR)|2.19||||0.0934|2-Sided|95.0|0.9|5.5|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705362|NCT00913458|3136432|Superiority or Other||Odds Ratio (OR)|0.77||||0.5951|2-Sided|95.0|0.3|2.0|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705363|NCT00913458|3136433|Superiority or Other||Odds Ratio (OR)|4.87||||0.0031|2-Sided|95.0|1.7|13.9|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705364|NCT00913458|3136433|Superiority or Other||Odds Ratio (OR)|8.88||||0.0011|2-Sided|95.0|2.4|33.1|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705365|NCT00913458|3136433|Superiority or Other||Odds Ratio (OR)|1.83||||0.4075|2-Sided|95.0|0.4|7.6|||Longitudinal statistical model|Odds ratios and p-values are based on a longitudinal statistical model with factors for treatment, visit, and interaction of treatment and visit.||Change from Week 52 to Week 91. The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705366|NCT00913458|3136434|Superiority or Other||||||<|0.0001|||||||McNemar|||"P-value is from McNemar’s test for no change from baseline in response rate.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"|
1705367|NCT00913458|3136435|Superiority or Other||||||<|0.0001|||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"|
1705368|NCT00913458|3136436|Superiority or Other||||||<|0.0001|||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"|
1705369|NCT00913458|3136437|Superiority or Other||||||<|0.0001|||||||Paired t-test|||"Significance tests were based on paired t‑tests using a 2‑sided α=0.05.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"|
1705372|NCT00913458|3136440|Superiority or Other||||||<|0.0001|||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"|
1705373|NCT00913458|3136441|Superiority or Other||||||<|0.0001|||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"|
1705374|NCT00913458|3136442|Superiority or Other||||||<|0.0001|||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 week and final on therapy"|
1705375|NCT00913458|3136443|Superiority or Other||||||<|0.0001|||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~Week 2, 4, 8, 13, 26, 39, 52 and final on therapy"|
1705376|NCT00913458|3136444|Superiority or Other||||||<|0.0001|||||||Paired t-test|||"Significance tests were based on paired t‑tests using a 2‑sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"|
1705377|NCT00913458|3136445|Superiority or Other|||||||0.0005|||||||Paired t-test|||"Significance tests were based on paired t‑tests using a 2‑sided α=0.05.~Final on therapy"|
1705378|NCT00913458|3136445|Superiority or Other|||||||0.0002|||||||Paired t-test|||"Significance tests were based on paired t‑tests using a 2‑sided α=0.05.~Week 52"|
1705379|NCT00913458|3136445|Superiority or Other|||||||0.0027|||||||Paired t-test|||"Significance tests were based on paired t‑tests using a 2‑sided α=0.05.~Week 39"|
1705380|NCT00913458|3136445|Superiority or Other|||||||0.0053|||||||Paired t-test|||"Significance tests were based on paired t‑tests using a 2‑sided α=0.05.~Week 26"|
1705381|NCT00913458|3136445|Superiority or Other|||||||0.0063|||||||Paired t-test|||"Significance tests were based on paired t‑tests using a 2‑sided α=0.05.~Week 13"|
1705382|NCT00913458|3136446|Superiority or Other||||||<|0.0001|||||||Paired t-test|||"Significance tests were based on paired t‑tests using a 2‑sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"|
1705383|NCT00913458|3136447|Superiority or Other||||||<|0.0001|||||||Paired t-test|||"Significance tests were based on paired t‑tests using a 2‑sided α=0.05.~Week 13, 26, 39, 52 and final on therapy"|
1705384|NCT00913458|3136448|Superiority or Other|||||||0.0286|||||||Paired t-test|||"Significance tests were based on paired t‑tests using a 2‑sided α=0.05.~Final on therapy"|
1705385|NCT00913458|3136448|Superiority or Other|||||||0.1183|||||||Paired t-test|||"Significance tests were based on paired t‑tests using a 2‑sided α=0.05.~Week 52"|
1705386|NCT00913458|3136449|Superiority or Other||||||<|0.0001|||||||Binomial test|||"Binomial test-value tests the null hypothesis that the proportion is significantly different from 0.~End of Phase 1"|
1705387|NCT00913458|3136450|Superiority or Other||Odds Ratio (OR)|2.22||||0.0397|2-Sided|95.0|1.0|4.8||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Linear|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705388|NCT00913458|3136450|Superiority or Other||Odds Ratio (OR)|2.61||||0.0085|2-Sided|95.0|1.3|5.3||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Logistic|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705389|NCT00913458|3136450|Superiority or Other||Odds Ratio (OR)|5.8|||<|0.0001|2-Sided|95.0|2.7|12.5||The rate of sustained remission was analyzed using a logistic regression model with a 2-sided significance level of 5%.|Regression, Logistic|Values are based on a logistic regression model with treatment as the only factor.||The hypothesis of primary interest was the superiority of E25+MTX compared with PBO.|
1705390|NCT00913081|3136471|Superiority or Other|||||||0.5|||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow.|
1705391|NCT00913081|3136471|Superiority or Other|||||||0.8|||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow.|
1705392|NCT00913081|3136471|Superiority or Other|||||||0.5|||||||Mixed Models Analysis|||The null hypothesis is that quercetin, at any dose, does not attenuate niacin-induced increases in dermal blood flow. Because quercetin has not been used to inhibit flushing from niacin in humans, sample size could not be determined statistically. A sample size of 8 men and 8 women was expected to allow separate estimates of effect size, variability, and shape of distribution for men and women.|
1705393|NCT00912964|3136506|Superiority or Other||LS Mean Difference|-0.59||||0.007|2-Sided|95.0|-1.01|-0.16||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1705394|NCT00912964|3136506|Superiority or Other||LS Mean Difference|-0.33||||0.13|2-Sided|95.0|-0.76|0.1||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1705404|NCT00912964|3136511|Superiority or Other||LS Mean Difference|-0.47||||0.007|2-Sided|95.0|-0.82|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1705395|NCT00912964|3136507|Superiority or Other||LS Mean Difference|-0.39||||0.002|2-Sided|95.0|-0.69|-0.08||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1705396|NCT00912964|3136507|Superiority or Other||LS Mean Difference|-0.36||||0.004|2-Sided|95.0|-0.67|-0.05||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1705397|NCT00912964|3136508|Superiority or Other||LS Mean Difference|-0.14|||<|0.001|2-Sided|95.0|-0.22|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1705398|NCT00912964|3136508|Superiority or Other||LS mean Difference|-0.07|||<|0.083|2-Sided|95.0|-0.15|0.01||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1705399|NCT00912964|3136509|Superiority or Other||LS mean Difference|-0.37||||0.035|2-Sided|95.0|-0.71|-0.03||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1705400|NCT00912964|3136509|Superiority or Other||LS Difference|-0.18||||0.3|2-Sided|95.0|-0.53|0.16||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1705401|NCT00912964|3136510|Superiority or Other||LS Mean Difference|-0.51|||<|0.001|2-Sided|95.0|-0.85|-0.17||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1705402|NCT00912964|3136510|Superiority or Other||LS Mean Difference|-0.34|||<|0.039|2-Sided|95.0|-0.68|-0.01||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1705403|NCT00912964|3136511|Superiority or Other||LS Mean Difference|-0.42||||0.015|2-Sided|95.0|-0.76|-0.08||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1705426|NCT00911937|3136587|Superiority or Other||Least squares mean difference|3.42|Standard Error of the Mean|1.34||0.011|2-Sided|95.0|0.79|6.05||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Concern domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705405|NCT00912964|3136512|Superiority or Other||LS Mean Difference|12.4|||<|0.001|2-Sided|95.0|6.3|18.6||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1705406|NCT00912964|3136512|Superiority or Other||LS Mean Difference|4.6|||<|0.15|2-Sided|95.0|-1.6|10.8||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1705407|NCT00912964|3136513|Superiority or Other||LS Mean Difference|-0.42||||0.001|2-Sided|95.0|-0.76|-0.08||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1705408|NCT00912964|3136513|Superiority or Other||LS Mean Difference|-0.4||||0.005|2-Sided|95.0|-0.74|-0.06||The response variable for the stratified rank ANCOVA was standardized ranks on change from Baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 6 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (8 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1705409|NCT00912808|3136522|Superiority or Other|||||||0.27|||||||t-test, 2 sided|||Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.|
1705410|NCT00912808|3136523|Superiority or Other|||||||0.049|||||||t-test, 2 sided|||Means and standard deviations were calculated to describe the subject baseline characteristics. Paired t-tests evaluated the difference between baseline and end of treatment frequency of falls. Changes post-treatment from baseline in secondary measures were also compared between the donepezil and placebo phases with paired t-tests or Wilcoxon signed rank tests when data was nonparametric. SPSS was used for the analysis.|
1705411|NCT00912795|3136524|Superiority or Other||Risk Ratio (RR)|2.0|||||2-Sided|95.0|0.62|6.3|||||||
1705412|NCT00912795|3136525|Superiority or Other||Risk Ratio (RR)|2.5|||||2-Sided|95.0|0.81|7.5|||||||
1705413|NCT00912795|3136526|Superiority or Other||Risk Ratio (RR)|1.3|||||2-Sided|95.0|0.5|3.2|||||||
1705414|NCT00912795|3136527|Superiority or Other||Risk Ratio (RR)|2.0|||||2-Sided|95.0|0.62|6.3|||||||
1705415|NCT00912301|3136542|Superiority or Other|||||||0.01|||||||Dunnett's test|pairwise comparison high dose NaCDC against placebo|||
1705416|NCT00912301|3136542|Superiority or Other|||||||0.031|||||||Dunnett's test|pairwise comparison low dose NaCDC against placebo|||
1705417|NCT00912093|3136571|Superiority or Other||||||<|0.001|||||||Peto-Peto Wilcoxon||||
1705418|NCT00912093|3136572|Superiority or Other||||||<|0.001|||||||Peto-Peto Wilcoxon||||
1705419|NCT00912093|3136573|Superiority or Other|||||||0.012|||||||Peto Peto Wilcoxon||||
1705420|NCT00912093|3136574|Superiority or Other||||||<|0.001|||||||Peto-Peto Wilcoxon||||
1705421|NCT00912093|3136575|Superiority or Other||||||<|0.001|||||||Peto-Peto Wilcoxon||||
1705422|NCT00911937|3136587|Superiority or Other||Least squares mean difference|3.02|Standard Error of the Mean|1.17||0.01|2-Sided|95.0|0.72|5.32||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Total- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705423|NCT00911937|3136587|Superiority or Other||Least squares mean difference|1.86|Standard Error of the Mean|0.93||0.0458|2-Sided|95.0|0.03|3.68||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Social interaction domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705424|NCT00911937|3136587|Superiority or Other||Least squares mean difference|3.48|Standard Error of the Mean|1.51||0.0218|2-Sided|95.0|0.51|6.45||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Sleep domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705425|NCT00911937|3136587|Superiority or Other||Least squares mean difference|3.14|Standard Error of the Mean|1.35||0.02|2-Sided|95.0|0.5|5.79||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: Coping domain- ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705472|NCT00911508|3136674|Superiority||Cox Proportional Hazard|1.13|||||2-Sided|95.0|0.41|3.09|||||||
1705427|NCT00911937|3136589|Superiority or Other||Least squares mean difference|-4.37|Standard Error of the Mean|1.26||0.0006|2-Sided|95.0|-6.84|-1.89||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705428|NCT00911937|3136591|Superiority or Other||Least squares mean difference|-0.85|Standard Error of the Mean|4.22||0.8396|2-Sided|95.0|-9.14|7.44||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705429|NCT00911937|3136593|Superiority or Other||Least squares mean difference|1.32|Standard Error of the Mean|7.2||0.8547|2-Sided|95.0|-12.82|15.46||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705430|NCT00911937|3136595|Superiority or Other||Least squares mean difference|-2.43|Standard Error of the Mean|0.69||0.0004|2-Sided|95.0|-3.78|-1.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705431|NCT00911937|3136595|Superiority or Other||Least squares mean difference|-1.56|Standard Error of the Mean|0.63||0.0131|2-Sided|95.0|-2.79|-0.33||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705432|NCT00911937|3136597|Superiority or Other||Least squares mean difference|-0.73|Standard Error of the Mean|0.24||0.0027|2-Sided|95.0|-1.2|-0.25||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705433|NCT00911937|3136597|Superiority or Other||Least squares mean difference|-0.39|Standard Error of the Mean|0.24||0.1018|2-Sided|95.0|-0.85|0.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705434|NCT00911937|3136600|Superiority or Other||Least squares mean difference|-0.19|Standard Error of the Mean|0.15||0.2166|2-Sided|95.0|-0.48|0.11||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705435|NCT00911937|3136600|Superiority or Other||Least squares mean difference|-0.14|Standard Error of the Mean|0.17||0.3954|2-Sided|95.0|-0.47|0.19||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705436|NCT00911937|3136602|Superiority or Other||||||<|0.0001||||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.|
1705437|NCT00911937|3136602|Superiority or Other||||||<|0.0041||||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.|
1705438|NCT00911937|3136603|Superiority or Other||Least squares mean difference|-0.79|Standard Error of the Mean|0.24||0.0009|2-Sided|95.0|-1.25|-0.32||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705439|NCT00911937|3136603|Superiority or Other||Least squares mean difference|-0.59|Standard Error of the Mean|0.22||0.0072|2-Sided|95.0|-1.03|-0.16||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705440|NCT00911937|3136605|Superiority or Other|||||||0.0004||||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.|
1705441|NCT00911937|3136605|Superiority or Other|||||||0.0016||||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 4: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.|
1705442|NCT00911937|3136606|Superiority or Other||Least squares mean difference|-0.56|Standard Error of the Mean|0.17||0.0014|2-Sided|95.0|-0.9|-0.22||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705443|NCT00911937|3136606|Superiority or Other||Least squares mean difference|-0.45|Standard Error of the Mean|0.15||0.0026|2-Sided|95.0|-0.74|-0.16||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705444|NCT00911937|3136608|Superiority or Other|||||||0.0023||||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.|
1705445|NCT00911937|3136609|Superiority or Other||Least Squares mean difference|-0.19|Standard Error of the Mean|0.07||0.0112|2-Sided|95.0|-0.33|-0.04||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 12: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705446|NCT00911937|3136609|Superiority or Other||Least squares mean difference|-0.12|Standard Error of the Mean|0.07||0.0827|2-Sided|95.0|-0.25|0.01||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Change at Week 4: ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705447|NCT00911937|3136611|Superiority or Other|||||||0.0001||||||Statistical testing, two-sided, was done at alpha = 0.05 level.|Ranked ANCOVA|Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.||Change at Week 12: Ranked ANCOVA model with terms for treatment and center with ranked baseline value as a covariate was used to calculate p-value.|
1705448|NCT00911937|3136612|Superiority or Other||Least squares mean difference|-0.13|Standard Error of the Mean|0.07||0.0772|2-Sided|95.0|-0.27|0.01||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||ANCOVA model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705449|NCT00911937|3136613|Superiority or Other||Least squares mean difference|-0.22|Standard Error of the Mean|0.08||0.003|2-Sided|95.0|-0.37|-0.08||Statistical testing, two-sided, was done at alpha = 0.05 level.|ANCOVA|||Analysis of covariance (ANCOVA) model with terms for treatment and center with centered baseline value as a covariate was used to calculate p-value.|
1705450|NCT00911820|3136627|Superiority|||||||0.721|||||||Log Rank||||
1705451|NCT00911820|3136628|Superiority|||||||0.605|||||||Fisher Exact||||
1705452|NCT00911820|3136630|Superiority|||||||0.714|||||||Log Rank||||
1705453|NCT00911807|3136643|Superiority or Other||Mean Difference (Final Values)|-0.45||||0.6962||95.0|-2.719|1.819||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'.|
1705454|NCT00911807|3136643|Superiority or Other||Mean Difference (Final Values)|-1.08||||0.3434||95.0|-3.324|1.163||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'.|
1705455|NCT00911807|3136643|Superiority or Other||Mean Difference (Final Values)|-0.63||||0.583||95.0|-2.891|1.63||No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|t-test, 2 sided|Comparisons between all pair of means were performed with two-sample t-tests within the ANCOVA model.||Multiple testing of individual null hypotheses that control for the overall significance level alpha = 0.05 were performed by using the 'closed testing procedure'|
1705456|NCT00911807|3136643|Superiority or Other||Mean Square (Factor Treatment)|19.59||||0.6348||||||ANCOVA F-test. The study was designed to show significant differences in each of the two primary variables. No adjustment for multiple testing was needed and all tests were done with retention of the full two-sided alpha-level of 0.05.|ANCOVA|ANCOVA with the week 28 ADAS-cog+ change score as dependent variable and the ADAS-cog+ baseline score as a covariate.||The null-hypothesis stated no differences between the three treatment groups regarding the mean change from baseline in ADAS-cog+ at week 28. A sample size of approximately 60 evaluable patients per treatment arm was estimated to allow for the detection of a significant group difference of two points in ADAS-cog+ week 28 change score (standard deviation [SD] 3.3) between the three groups with a power of > 80% and a probability level of alpha = 0.05 (two-sided).|
1705457|NCT00911768|3136644|Non-Inferiority or Equivalence|A non-inferiority analysis was conducted. We just compared the difference of unstimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.|Mean Difference (Final Values)|-0.086|Standard Error of the Mean|0.035|<|0.05||95.0|-0.155|-0.017|||t-test, 2 sided||||
1705458|NCT00911768|3136645|Non-Inferiority or Equivalence|A non-inferiority analysis was conducted. We just compared the difference of stimulated salivary rates between both groups at 8 weeks, because there were no definition of the effective margin.|Mean Difference (Final Values)|-0.346|Standard Error of the Mean|0.116|<|0.05||95.0|-0.576|-0.115|||t-test, 2 sided||||
1705459|NCT00911768|3136646|Superiority or Other||Mean Difference (Final Values)|0.181|Standard Error of the Mean|0.416|<|0.05||95.0|-0.647|1.008|||t-test, 2 sided||||
1705460|NCT00911625|3136652|Superiority||Odds Ratio (OR)|0.438||||0.0828|2-Sided|95.0|0.172|1.114|||Regression, Logistic|||The null hypothesis is that there is no difference in the odds of experiencing at least one blood glucose level below 70 mg/dL between the two treatment cohorts.|
1705461|NCT00911625|3136653|Superiority||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|9.502||0.958|2-Sided|95.0|-19.341|18.341|||t-test, 2 sided|||The null hypothesis is that there is no difference between the two treatment cohorts on their average blood glucose level|
1705462|NCT00911612|3136657|Superiority or Other|||||||0.02|||||||ANCOVA|||An analysis of covariance was used to compare drug with placebo adjusting for BMI and 7 alpha HCO.|
1705463|NCT00911612|3136658|Superiority or Other|||||||0.22||||||Not adjusted since only one comparison was made.|ANCOVA|||An analysis of covariance was used to compare drug with placebo adjusting for baseline geometric center at 24 hours , BMI, and 7 alpha CHO.|
1705464|NCT00911508|3136669|Superiority||Mean Difference (Net)|-1.0|||<|0.001|2-Sided|95.0|-1.7|-0.4|||Mixed Models Analysis|||5 Year|
1705465|NCT00911508|3136669|Superiority||Mean Difference (Net)|-1.5|||<|0.001|2-Sided|95.0|-2.0|-1.1|||Mixed Models Analysis|||12 Month|
1705466|NCT00911508|3136670|Superiority||Mean Difference (Net)|-1.4||||0.001|2-Sided|95.0|-1.9|-0.9|||Mixed Models Analysis|||5 Year|
1705467|NCT00911508|3136670|Superiority||Mean Difference (Net)|-1.7||||0.001|2-Sided|95.0|-2.3|-1.2|||Mixed Models Analysis|||12 Month|
1705468|NCT00911508|3136671|Superiority||Mean Difference (Net)|3.4|||<|0.001|2-Sided|95.0|2.1|4.8|||Mixed Models Analysis|||5 Years|
1705469|NCT00911508|3136671|Superiority||Mean Difference (Net)|5.3|||<|0.001|2-Sided|95.0|3.7|6.9|||Mixed Models Analysis|||12 Month|
1705470|NCT00911508|3136672|Superiority||Cox Proportional Hazard|0.86|||||2-Sided|95.0|0.77|0.97|||||||
1705471|NCT00911508|3136673|Superiority||Cox Proportional Hazard|0.52|||||2-Sided|95.0|0.45|0.6|||||||
1705480|NCT00911300|3136704|Superiority or Other||Percentage of participants|0.5||||1|2-Sided|95.0|-2.0|3.1|||Fisher Exact||The estimated value is the absolute percent difference between Fondaparinux and UFH/VKA.||
1705481|NCT00911274|3136705|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|97.77|104.34|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705482|NCT00911274|3136706|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.3||||||90.0|97.84|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705483|NCT00911274|3136707|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.41||||||90.0|82.77|103.18|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705484|NCT00911170|3136709|Superiority or Other||Odds Ratio (OR)|0.27|||<|0.001|2-Sided|95.0|0.13|0.56|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR < 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.||
1705485|NCT00911170|3136710|Superiority or Other||Odds Ratio (OR)|0.18|||<|0.001||95.0|0.1|0.32|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR < 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.||
1705486|NCT00911170|3136711|Superiority or Other||Odds Ratio (OR)|0.66||||0.312||95.0|0.29|1.49|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR < 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.||
1705487|NCT00911170|3136712|Superiority or Other||Odds Ratio (OR)|1.06||||0.683|2-Sided|95.0|0.81|1.39|||Cochran-Mantel-Haenszel|The p-value is from the Cochran Mantel Haenszel (CMH) test adjusting for the randomization stratification factors.|Odds ratio (OR) adjusted for the randomization stratification factors. An OR > 1.0 indicates a higher event rate for the pegfilgrastim arm relative to the placebo arm.||
1705488|NCT00911170|3136713|Superiority or Other||Hazard Ratio (HR)|1.07||||0.502|2-Sided|95.0|0.88|1.29|||Log Rank|P-values are based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.||
1705489|NCT00911170|3136714|Superiority or Other||Hazard Ratio (HR)|1.05||||0.552|2-Sided|95.0|0.88|1.26|||Log Rank|P-values are based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.||
1705490|NCT00911170|3136715|Superiority or Other||Hazard Ratio (HR)|1.05||||0.704|2-Sided|95.0|0.81|1.36|||Log Rank|P-values based on the log-rank test statistic from the Kaplan-Meier survival analysis stratified by the 3 randomization factors.|Based on Cox proportional Hazard model stratified by chemotherapy regimen, region and disease status. A HR< 1.0 indicates a lower average event rate and a longer survival time for the pegfilgrastim arm relative to the placebo arm.||
1705491|NCT00911170|3136716|Superiority or Other||Odds Ratio (OR)|0.41||||0.014|2-Sided|95.0|0.19|0.86|||Cochran-Mantel-Haenszel|The p-value is adjusted for the randomization stratification factors (chemotherapy regimen, geographic region, disease stage).|Odds ratio adjusted for the randomization stratification factors. An OR < 1.0 indicates a lower event rate for the pegfilgrastim arm relative to the placebo arm.|The primary hypothesis was that the percentage of participants treated with study chemotherapy and bevacizumab who experience grade 3/4 febrile neutropenia (FN) would be lower in participants randomized to the pegfilgrastim arm compared to placebo arm. The study was designed to have at least 90% power at the 2-sided 0.05 significance level to detect a 6% difference in incidence of grade 3/4 FN from 9% to 3%, which is approximately a 66.7% relative reduction.|
1705492|NCT00910988|3136734|Superiority or Other|||||||0.57||||||This p-value corresponds to the 3 way interaction between time, drug (olanzapine vs ziprasidone), and order (drug first vs placebo first) and is not adjusted for multiple comparisons.|ANCOVA|||The null hypothesis is that olanzapine and ziprasidone would result in acute decreases in insulin sensitivity compared to placebo at adipose tissue, which was measured by evaluating the rate of appearance of labeled glycerol. The alternative hypothesis is that olanzapine, but not ziprasidone, would result in acute decreases in insulin sensitivity compared to placebo at adipose tissue.|
1705493|NCT00910988|3136737|Superiority or Other|||||||0.001||||||This p-value corresponds to the two way interaction between time and order and is not adjusted for multiple comparisons. The a priori threshold for statistical significance is alpha equal to 0.05. There was no 3 way interaction.|ANCOVA|Repeated measures ANCOVA with time as the repeated measure, drug assignment as a fixed factor, and order as a fixed factor.||The hypothesis being tested is whether there is a significant effect of one or both antipsychotics on whole body insulin sensitivity. Sample size was calculated using power calculations to detect significant effects of treatment on insulin sensitivity. Drug assignment is a 2-level fixed factor (olanzapine vs ziprasidone) as is order (drug first vs placebo first). Baseline of the dependent variable as well as baseline DEXA total fat were entered into the model as covariates.|
1705494|NCT00910962|3136738|Superiority||Mean Difference (Final Values)|-0.14||||0.047|2-Sided|95.0|-0.28|0.0|||Repeated measures ANCOVA||||
1705495|NCT00910962|3136738|Superiority||Mean Difference (Final Values)|-0.17||||0.036|2-Sided|95.0|-0.32|-0.01|||Repeated measures ANCOVA||||
1705496|NCT00910962|3136738|Superiority||Mean Difference (Final Values)|-0.11||||0.137|2-Sided|95.0|-0.26|0.04|||Repeated measures ANCOVA||||
1705497|NCT00910962|3136739|Superiority||Mean Difference (Final Values)|-0.24||||0.011|2-Sided|95.0|-0.42|-0.06|||Repeated measures ANCOVA||||
1705498|NCT00910962|3136739|Superiority||Mean Difference (Final Values)|-0.24||||0.021|2-Sided|95.0|-0.45|-0.04|||Repeated measures ANCOVA||||
1705501|NCT00910962|3136740|Superiority||Mean Difference (Final Values)|-7.13||||0.614|2-Sided|95.0|-35.22|20.96|||Repeated measures ANCOVA||||
1705502|NCT00910962|3136740|Superiority||Mean Difference (Final Values)|-22.21||||0.109|2-Sided|95.0|-49.51|5.09|||Repeated measures ANCOVA||||
1705503|NCT00910962|3136741|Superiority||Mean Difference (Final Values)|-16.52||||0.01|2-Sided|95.0|-28.91|-4.13|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For LVESV|
1705504|NCT00910962|3136741|Superiority||Mean Difference (Final Values)|-17.22||||0.016|2-Sided|95.0|-31.14|-3.29|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For LVESV|
1705505|NCT00910962|3136741|Superiority||Mean Difference (Final Values)|-15.82||||0.024|2-Sided|95.0|-29.51|-2.14|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For LVESV|
1705506|NCT00910962|3136741|Superiority||Mean Difference (Final Values)|-20.09||||0.021|2-Sided|95.0|-37.01|-3.18|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For LVEDV|
1705507|NCT00910962|3136741|Superiority||Mean Difference (Final Values)|-18.65||||0.053|2-Sided|95.0|-37.58|0.29|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For LVEDV|
1705508|NCT00910962|3136741|Superiority||Mean Difference (Final Values)|-21.53||||0.025|2-Sided|95.0|-40.27|-2.79|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For LVEDV|
1705509|NCT00910962|3136742|Superiority||Mean Difference (Final Values)|5.14||||0.039|2-Sided|95.0|0.28|10.0|||Repeated measures ANCOVA||||
1705510|NCT00910962|3136742|Superiority||Mean Difference (Final Values)|6.05||||0.029|2-Sided|95.0|0.63|11.47|||Repeated measures ANCOVA||||
1705511|NCT00910962|3136742|Superiority||Mean Difference (Final Values)|4.22||||0.124|2-Sided|95.0|-1.18|9.62|||Repeated measures ANCOVA||||
1705512|NCT00910962|3136743|Superiority||Mean Difference (Final Values)|-2.19||||0.096|2-Sided|95.0|-4.78|0.4|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12|
1705513|NCT00910962|3136743|Superiority||Mean Difference (Final Values)|-2.47||||0.093|2-Sided|95.0|-5.37|0.43|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12|
1705514|NCT00910962|3136743|Superiority||Mean Difference (Final Values)|-1.91||||0.184|2-Sided|95.0|-4.74|0.92|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12|
1705515|NCT00910962|3136743|Superiority||Mean Difference (Final Values)|-2.38||||0.126|2-Sided|95.0|-5.44|0.69|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Day 3-5 (visit 1)|
1705516|NCT00910962|3136743|Superiority||Mean Difference (Final Values)|-2.84||||0.106|2-Sided|95.0|-6.29|0.62|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Day 3-5 (visit 1)|
1705517|NCT00910962|3136743|Superiority||Mean Difference (Final Values)|-1.92||||0.254|2-Sided|95.0|-5.25|1.41|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Day 3-5 (visit 1)|
1705518|NCT00910962|3136744|Superiority||test to reference ratio|0.76||||0.04|2-Sided|95.0|0.6|0.98|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12|
1705519|NCT00910962|3136744|Superiority||test to reference ratio|0.81||||0.14|2-Sided|95.0|0.61|1.07|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12|
1705520|NCT00910962|3136744|Superiority||test to reference ratio|0.73||||0.03|2-Sided|95.0|0.55|0.96|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12|
1705521|NCT00910962|3136744|Superiority||test to reference ratio|0.92||||0.5|2-Sided|95.0|0.74|1.16|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For discharge/early withdrawal|
1705522|NCT00910962|3136744|Superiority||test to reference ratio|0.92||||0.52|2-Sided|95.0|0.72|1.18|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For discharge/early withdrawal|
1705523|NCT00910962|3136744|Superiority||test to reference ratio|0.93||||0.57|2-Sided|95.0|0.72|1.2|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For discharge/early withdrawal|
1705524|NCT00910962|3136745|Superiority||test to reference ratio|1.03||||0.76|2-Sided|95.0|0.84|1.27|||Repeated measures ANCOVA||||
1705525|NCT00910962|3136745|Superiority||test to reference ratio|1.08||||0.52|2-Sided|95.0|0.85|1.36|||Repeated measures ANCOVA||||
1705526|NCT00910962|3136745|Superiority||test to reference ratio|0.99||||0.92|2-Sided|95.0|0.78|1.25|||Repeated measures ANCOVA||||
1705527|NCT00910962|3136746|Superiority||test to reference ratio|1.05||||0.47|2-Sided|95.0|0.92|1.21|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 72 hours|
1705528|NCT00910962|3136746|Superiority||test to reference ratio|1.07||||0.39|2-Sided|95.0|0.92|1.25|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 72 hours|
1705529|NCT00910962|3136746|Superiority||test to reference ratio|1.04||||0.66|2-Sided|95.0|0.89|1.21|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 72 hours|
1705530|NCT00910962|3136747|Superiority||test to reference ratio|0.89||||0.246|2-Sided|95.0|0.73|1.09|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 12|
1705531|NCT00910962|3136747|Superiority||test to reference ratio|0.97||||0.824|2-Sided|95.0|0.78|1.22|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 12|
1705532|NCT00910962|3136747|Superiority||test to reference ratio|0.81||||0.068|2-Sided|95.0|0.65|1.02|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 12|
1705533|NCT00910962|3136747|Superiority||test to reference ratio|0.82||||0.075|2-Sided|95.0|0.65|1.02|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 2|
1705534|NCT00910962|3136747|Superiority||test to reference ratio|0.88||||0.315|2-Sided|95.0|0.68|1.13|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 2|
1705535|NCT00910962|3136747|Superiority||test to reference ratio|0.76||||0.031|2-Sided|95.0|0.59|0.98|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 2|
1705536|NCT00910962|3136747|Superiority||test to reference ratio|0.59|||<|0.001|2-Sided|95.0|0.48|0.73|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 24 hours|
1705537|NCT00910962|3136747|Superiority||test to reference ratio|0.64|||<|0.001|2-Sided|95.0|0.5|0.82|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 24 hours|
1705538|NCT00910962|3136747|Superiority||test to reference ratio|0.54|||<|0.001|2-Sided|95.0|0.43|0.69|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 24 hours|
1705539|NCT00910962|3136748|Superiority||test to reference ratio|1.64||||0.001|2-Sided|95.0|1.21|2.21|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 14|
1705540|NCT00910962|3136748|Superiority||test to reference ratio|1.69||||0.002|2-Sided|95.0|1.21|2.38|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 14|
1705541|NCT00910962|3136748|Superiority||test to reference ratio|1.58||||0.008|2-Sided|95.0|1.13|2.22|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 14|
1705542|NCT00910962|3136748|Superiority||test to reference ratio|0.89||||0.457|2-Sided|95.0|0.66|1.2|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 8|
1705543|NCT00910962|3136748|Superiority||test to reference ratio|0.99||||0.965|2-Sided|95.0|0.71|1.39|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 8|
1705544|NCT00910962|3136748|Superiority||test to reference ratio|0.8||||0.204|2-Sided|95.0|0.58|1.13|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 8|
1705545|NCT00910962|3136748|Superiority||test to reference ratio|0.83||||0.253|2-Sided|95.0|0.61|1.14|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 4|
1705546|NCT00910962|3136748|Superiority||test to reference ratio|0.9||||0.548|2-Sided|95.0|0.63|1.28|||ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 4|
1705547|NCT00910962|3136748|Superiority||test to reference ratio|0.78||||0.157|2-Sided|95.0|0.55|1.1|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 4|
1705548|NCT00910962|3136748|Superiority||test to reference ratio|0.7||||0.044|2-Sided|95.0|0.5|0.99|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For Week 2|
1705549|NCT00910962|3136748|Superiority||test to reference ratio|0.7||||0.075|2-Sided|95.0|0.48|1.04|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For Week 2|
1705550|NCT00910962|3136748|Superiority||test to reference ratio|0.7||||0.073|2-Sided|95.0|0.48|1.03|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For Week 2|
1705551|NCT00910962|3136748|Superiority||test to reference ratio|0.64||||0.015|2-Sided|95.0|0.45|0.92|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 72 hours|
1705552|NCT00910962|3136748|Superiority||test to reference ratio|0.6||||0.013|2-Sided|95.0|0.4|0.9|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 72 hours|
1705553|NCT00910962|3136748|Superiority||test to reference ratio|0.68||||0.059|2-Sided|95.0|0.45|1.01|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 72 hours|
1705554|NCT00910962|3136748|Superiority||test to reference ratio|0.51|||<|0.001|2-Sided|95.0|0.38|0.69|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 48 hours|
1705555|NCT00910962|3136748|Superiority||test to reference ratio|0.47|||<|0.001|2-Sided|95.0|0.33|0.65|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 48 hours|
1705556|NCT00910962|3136748|Superiority||test to reference ratio|0.56|||<|0.001|2-Sided|95.0|0.4|0.78|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 48 hours|
1705557|NCT00910962|3136748|Superiority||test to reference ratio|0.71|||<|0.003|2-Sided|95.0|0.57|0.89|||Repeated measures ANCOVA|||Placebo (P) vs A and B Combined (C): For 24 hours|
1705558|NCT00910962|3136748|Superiority||test to reference ratio|0.66|||<|0.001|2-Sided|95.0|0.52|0.85|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 15 mg followed by Losmapimod 7.5 mg (B): For 24 hours|
1705559|NCT00910962|3136748|Superiority||Test to reference ratio|0.77|||<|0.04|2-Sided|95.0|0.6|0.99|||Repeated measures ANCOVA|||Placebo (P) vs Losmapimod 7.5 mg (A): For 24 hours|
1705560|NCT00910962|3136749|Superiority||test to reference ratio|1.05||||0.65|2-Sided|95.0|0.84|1.32|||ANCOVA||||
1705561|NCT00910962|3136749|Superiority||test to reference ratio|1.08||||0.56|2-Sided|95.0|0.84|1.39|||ANCOVA||||
1705562|NCT00910962|3136749|Superiority||test to reference ratio|1.03||||0.83|2-Sided|95.0|0.8|1.32|||ANCOVA||||
1705563|NCT00910962|3136750|Superiority||test to treatment ratio|0.87||||0.317|2-Sided|95.0|0.66|1.14|||Repeated measures ANCOVA||||
1705564|NCT00910962|3136750|Superiority||test to reference ratio|0.95||||0.744|2-Sided|95.0|0.7|1.29|||Repeated measures ANCOVA||||
1705565|NCT00910962|3136750|Superiority||test to reference ratio|0.8||||0.151|2-Sided|95.0|0.59|1.09|||Repeated measures ANCOVA||||
1705566|NCT00910962|3136756|Superiority or Other||Hazard Ratio (HR)|0.89||||0.659|2-Sided|95.0|0.52|1.51|||Cox’ proportional hazards model||||
1705567|NCT00910962|3136756|Superiority or Other||Hazard Ratio (HR)|1.07||||0.8235|2-Sided|95.0|0.6|1.9|||Cox’ proportional hazards model||||
1705568|NCT00910962|3136756|Superiority or Other||Hazard Ratio (HR)|0.72||||0.299|2-Sided|95.0|0.39|1.34|||Cox’ proportional hazards model||||
1705569|NCT00910962|3136757|Superiority||Hazard Ratio (HR)|0.9||||0.6805|2-Sided|95.0|0.56|1.46|||Cox’ proportional hazards model||||
1705570|NCT00910962|3136757|Superiority||Hazard Ratio (HR)|1.02||||0.9318|2-Sided|95.0|0.6|1.74|||Cox’ proportional hazards model||||
1705571|NCT00910962|3136757|Superiority||Hazard Ratio (HR)|0.79||||0.411|2-Sided|95.0|0.46|1.38|||Cox’ proportional hazards model||||
1705572|NCT00910910|3136763|Superiority or Other||Cox Proportional Hazard|1.06||||0.709|2-Sided|90.0|0.83|1.34|||stratified log rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups||
1705573|NCT00910910|3136764|Superiority||Cox Proportional Hazard|1.03||||0.883|2-Sided|90.0|0.73|1.46|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.||
1705574|NCT00910910|3136767|Superiority||Cox Proportional Hazard|0.71||||0.149|2-Sided|90.0|0.48|1.05|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.||
1705575|NCT00910910|3136768|Superiority or Other||Hazard Ratio (HR)|0.94||||0.826|2-Sided|90.0|0.58|1.52|||Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups||
1705578|NCT00910910|3136773|Superiority||Cox Proportional Hazard|0.99||||0.967|2-Sided|90.0|0.76|1.29||The p-value is based on a stratified log-rank test|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|Stratification factors: Disease stage (Binet A or Binet B or Rai I or Rai II versus (VS) Binet C or Rai III or Rai IV); Presence of at least one of the co-morbidities Asparate transaminase (AST)/Alanine transaminase (ALT) ≥ 3.0 times Upper Limits of Normal (ULN,) Creatinine clearance ≥ 30 to < 60 mL/min, Yes VS No); Presence of at least one 11q deletion, 17p deletion, unmutated Immunoglobulin Heavy-chain Variable-region (IgVH) or Beta-2 Microglobulin (ß2M )> 4.0 mg/L (Yes versus No VS Unknown)|
1705579|NCT00910910|3136774|Superiority||Hazard Ratio (HR)|1.21||||0.323|2-Sided|90.0|0.88|1.66|||stratified log rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.|Stratification factors: Disease stage (Binet A or Binet B or Rai I or Rai II versus (VS) Binet C or Rai III or Rai IV); Presence of at least one of the co-morbidities Asparate transaminase (AST)/Alanine transaminase (ALT) ≥ 3.0 times Upper Limits of Normal (ULN,) Creatinine clearance ≥ 30 to < 60 mL/min, Yes VS No); Presence of at least one 11q deletion, 17p deletion, unmutated Immunoglobulin Heavy-chain Variable-region (IgVH) or Beta-2 Microglobulin (ß2M )> 4.0 mg/L (Yes versus No VS Unknown)|
1705580|NCT00910689|3136806|Superiority or Other||Mean Difference (Net)|1.1|Standard Deviation|2.83|>|0.03||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.|
1705581|NCT00910689|3136806|Superiority or Other||Mean Difference (Net)|0.8|Standard Deviation|2.45|>|0.08||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.|
1705582|NCT00910689|3136806|Superiority or Other||Mean Difference (Net)|0.3|Standard Deviation|2.85|>|0.56||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.|
1705583|NCT00910689|3136806|Superiority or Other||Mean Difference (Net)|5.6|Standard Deviation|2.99|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.|
1705584|NCT00910689|3136806|Superiority or Other||Mean Difference (Net)|6.7|Standard Deviation|3.29|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.|
1705585|NCT00910689|3136806|Superiority or Other||Mean Difference (Net)|6.4|Standard Deviation|3.0|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.|
1705586|NCT00910689|3136807|Superiority or Other||Mean Difference (Net)|0.2|Standard Deviation|1.68|>|0.21||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.|
1705587|NCT00910689|3136807|Superiority or Other||Mean Difference (Net)|0.2|Standard Deviation|1.34|>|0.33||95.0||||Bonerfoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.|
1705588|NCT00910689|3136807|Superiority or Other||Mean Difference (Net)|0.6|Standard Deviation|1.69|>|0.04||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.|
1705589|NCT00910689|3136807|Superiority or Other||Mean Difference (Net)|2.0|Standard Deviation|1.69|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.|
1705590|NCT00910689|3136807|Superiority or Other||Mean Difference (Net)|1.6|Standard Deviation|1.96|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.|
1705591|NCT00910689|3136807|Superiority or Other||Mean Difference (Net)|2.2|Standard Deviation|1.7|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.|
1705592|NCT00910689|3136808|Superiority or Other||Mean Difference (Net)|0.2|Standard Deviation|0.89|>|0.2|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.|
1705593|NCT00910689|3136808|Superiority or Other||Mean Difference (Net)|1.3|Standard Deviation|0.95|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.|
1705594|NCT00910689|3136808|Superiority or Other||Mean Difference (Net)|1.1|Standard Deviation|0.86|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Significant post-test contrast. Mean difference in change.|
1705595|NCT00910689|3136808|Superiority or Other||Mean Difference (Net)|0.2|Standard Deviation|0.67|>|0.05|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.|
1705596|NCT00910689|3136808|Superiority or Other||Mean Difference (Net)|0.0|Standard Deviation|0.79|>|0.83|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.|
1705597|NCT00910689|3136808|Superiority or Other||Mean Difference (Net)|1.3|Standard Deviation|0.77|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.|
1705598|NCT00910689|3136809|Superiority or Other||Mean Difference (Net)|0.1|Standard Deviation|2.38|>|0.87||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.|
1705599|NCT00910689|3136809|Superiority or Other||Mean Difference (Net)|4.5|Standard Deviation|1.83|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.|
1705600|NCT00910689|3136809|Superiority or Other||Mean Difference (Net)|5.9|Standard Deviation|2.03|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.|
1705868|NCT00906074|3137455|Superiority or Other|||||||0.289|||||||Chi-squared|Chi-squared Pearson||Diabetes mellitus|
1705601|NCT00910689|3136809|Superiority or Other||Mean Difference (Net)|1.4|Standard Deviation|1.67|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.|
1705602|NCT00910689|3136809|Superiority or Other||Mean Difference (Net)|6.0|Standard Deviation|2.41|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.|
1705603|NCT00910689|3136809|Superiority or Other||Mean Difference (Net)|1.5|Standard Deviation|2.18|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.|
1705604|NCT00910689|3136809|Superiority or Other||||||<|0.005||||||Post tests consisted of 6 pair wise contrasts: The first 3 contrasts compared each of the 3 additive treatments (Trial Arms 2, 3, 4) to OAT + PL (Trial arm 1); three additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure controlled the familywise type I error for the 6 contrasts at .05. Adjusted p=.0083.||Omnibus test:A mixed model with fixed effects for treatment, time (defined as the natural log of months), and the treatment-by-time interaction and pretreatment Migraine Specific Quality of Life scores as covariate was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects (using the PROC MIXED procedure in SAS statistical software, version 9; www. sas.com).A significant treatment by time interaction (p < .05, 2-tailed) was followed by post-tests|
1705605|NCT00910689|3136810|Superiority or Other||Mean Difference (Net)|0.6|Standard Deviation|1.43|>|0.02||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|||Post-test contrast. Mean difference in change.|
1705606|NCT00910689|3136810|Superiority or Other||Mean Difference (Net)|0.1|Standard Deviation|1.35|>|0.79||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.|
1705607|NCT00910689|3136810|Superiority or Other||Mean Difference (Net)|0.5|Standard Deviation|1.2|>|0.02|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.|
1705608|NCT00910689|3136810|Superiority or Other||Mean Difference (Net)|2.1|Standard Deviation|1.26|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.|
1705609|NCT00910689|3136810|Superiority or Other||Mean Difference (Net)|1.5|Standard Deviation|1.12|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.|
1705610|NCT00910689|3136810|Superiority or Other||Mean Difference (Net)|2.0|Standard Deviation|1.03|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.|
1705611|NCT00910689|3136810|Superiority or Other||||||<|0.03||||||6 pair wise contrasts were conducted: The first 3 contrasts compared each of the 3 additive treatments to OAT + PL. The 3 additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure was used to control the family wise type I error for the 6 post test contrasts at .05. Adjusted p =.0083.||Omnibus test:A mixed model with fixed effects for treatment, time (defined as the natural log of months), and the treatment-by-time interaction was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects (PROC MIXED, SAS 9).When the treatment by time interaction was significant (p < .05, 2-tailed)post-tests were conducted (see below).Details of significant post tests are reported as separate analyses.|
1705612|NCT00910689|3136811|Superiority or Other||Mean Difference (Net)|0.1|Standard Deviation|0.72|>|0.29|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.|
1705613|NCT00910689|3136811|Superiority or Other||Mean Difference (Net)|1.3|Standard Deviation|0.61|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 120.||Post-test contrast. Mean difference in change.|
1705614|NCT00910689|3136811|Superiority or Other||Mean Difference (Net)|1.1|Standard Deviation|0.69|<|0.001|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.|
1705615|NCT00910689|3136811|Superiority or Other||Mean Difference (Net)|0.0|Standard Deviation|0.59|>|0.98|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 106.||Post-test contrast. Mean difference in change.|
1705616|NCT00910689|3136811|Superiority or Other||Mean Difference (Net)|0.1|Standard Deviation|0.68|>|0.25|2-Sided|95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 108.||Post-test contrast. Mean difference in change.|
1705617|NCT00910689|3136811|Superiority or Other||Mean Difference (Net)|1.2|Standard Deviation|0.57|<|0.001||95.0||||Bonferoni adjusted critical value p = .0083.|t-test, 2 sided|Degrees of freedom = 1 and 122.||Post-test contrast. Mean difference in change.|
1705618|NCT00910689|3136811|Superiority or Other||||||<|0.01||||||Post tests consisted of 6 pair wise contrasts: The first 3 contrasts compared each of the 3 additive treatments (Trial Arms 2, 3, 4) to OAT + PL (Trial arm 1); 3 additional contrasts compared the 3 additive treatments to one another.|Mixed Models Analysis|A Bonferoni procedure was used to control the family-wise type I error for the 6 post test contrasts at .05. Adjusted p =.0083.||Omnibus Test: A mixed model with fixed effects for treatment,natural time(defined as natural log of months) and treatment-by-time interaction was used to obtain maximum likelihood estimates of missing values and to evaluate treatment effects(using the PROC MIXED procedure in SAS statistical software,version 9;www.sas.com). A significant treatment by time interaction(p < .05, 2-tailed) was followed by post-tests (see below). Details of significant post tests are reported as separate analyses.|
1705619|NCT00910663|3136812|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.35||||||90.0|100.51|106.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705620|NCT00910663|3136813|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.81||||||90.0|100.23|105.45|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705621|NCT00910663|3136814|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.01||||||90.0|90.01|104.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705622|NCT00910273|3136824|Superiority or Other||Mean Difference (Final Values)|0.89||||0.204|2-Sided|95.0|-0.52|2.3|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12|
1705623|NCT00910273|3136824|Superiority or Other||Mean Difference (Final Values)|0.34||||0.575|2-Sided|95.0|-0.89|1.57|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4|
1705624|NCT00910273|3136825|Superiority or Other||Mean Difference (Final Values)|-1.28||||0.048|2-Sided|95.0|-2.55|-0.01|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12|
1705625|NCT00910273|3136825|Superiority or Other||Mean Difference (Final Values)|-1.09||||0.041|2-Sided|95.0|-2.13|-0.05|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4|
1705626|NCT00910273|3136831|Superiority or Other||Mean Difference (Final Values)|-0.91||||0.029|2-Sided|95.0|-1.72|-0.1|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12|
1705627|NCT00910273|3136831|Superiority or Other||Mean Difference (Final Values)|-1.07||||0.003|2-Sided|95.0|-1.74|-0.4|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4|
1705628|NCT00910273|3136839|Superiority or Other||Mean Difference (Final Values)|-2.02||||0.021|2-Sided|95.0|-3.7|-0.33|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 12|
1705629|NCT00910273|3136839|Superiority or Other||Mean Difference (Final Values)|-1.77||||0.008|2-Sided|95.0|-3.05|-0.5|||Mixed Models Analysis||Adjusted mean difference (Etanercept-Placebo)|Week 4|
1705630|NCT00910273|3136844|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.592|2-Sided|95.0|-0.14|0.08|||ANCOVA|||Week 12; Internal Carotid Artery; Due to limited number of participants with visits after Week 12 analysis limited to Week 12|
1705631|NCT00910273|3136844|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.513|2-Sided|95.0|-0.13|0.07|||ANCOVA|||Week 12; Common Bulb; Due to limited number of participants with visits after Week 12 analysis limited to Week 12|
1705632|NCT00910273|3136844|Superiority or Other||Mean Difference (Final Values)|0.02||||0.65|2-Sided|95.0|-0.08|0.13|||ANCOVA|||Week 12; Common Carotid Artery; Due to limited number of participants with visits after Week 12 analysis limited to Week 12|
1705633|NCT00910273|3136845|Superiority or Other||Mean Difference (Final Values)|1.82||||0.476|2-Sided|95.0|-3.35|7.0|||Mixed Models Analysis||Analyses available for Week 4 only, due to limited number of participants for Week 24 to Week 52.|Week 4|
1705634|NCT00910273|3136846|Superiority or Other||Mean Difference (Final Values)|1.72||||0.608|2-Sided|95.0|-5.14|8.58|||Mixed Models Analysis|||"Null Hypothesis: No difference in Change in FMD at 12 weeks for Etanercept and placebo.~Alternative Hypothesis: Difference in Change in FMD at 12 weeks for Etanercept and placebo.~Sample size of 36 subjects per treatment arm was planned based on an expected difference of 0.9 in FMD (Standard Deviation [SD] 1.5), with 80% power and 5% significance level."|
1705635|NCT00910208|3136864|Superiority||||||<|0.001|||||||Fisher Exact||||
1705636|NCT00910208|3136865|Superiority|||||||0.99|||||||Fisher Exact||||
1705637|NCT00910208|3136866|Superiority|||||||0.033|||||||Chi-squared||||
1705638|NCT00910208|3136867|Superiority|||||||0.06|||||||ANOVA||||
1705639|NCT00910208|3136868|Superiority|||||||0.47|||||||Chi-squared||||
1705640|NCT00910208|3136869|Superiority|||||||0.82|||||||ANOVA||||
1705641|NCT00910091|3136870|Superiority or Other|||||||0.0484|||||||Kaplan-Meier Analysis||||
1705642|NCT00910091|3136871|Superiority or Other|||||||0.3078|||||||Kaplan-Meier Analysis||||
1705643|NCT00910091|3136872|Superiority or Other|||||||0.698|||||||Kaplan-Meier Analysis||||
1705644|NCT00910091|3136874|Superiority or Other|||||||0.0203|||||||Kaplan-Meier Analysis||||
1705645|NCT00910091|3136875|Superiority or Other|||||||0.1895|||||||Kaplan-Meier Analysis||||
1705646|NCT00909870|3136893|Superiority or Other||Difference in proportions|10.0||||0.0239||95.0||||Unadjusted|Chi-squared|Unadjusted||Pre-specified subgroup analysis of the primary endpoint|
1705647|NCT00909870|3136894|Superiority or Other||Median Difference (Final Values)|6.0||||0.4046||95.0||||This p-value did not meet the prespecified threshold for statistical significance of < 0.05|Log Rank||||
1705648|NCT00909870|3136895|Superiority or Other||Difference in proportions|6.5||||0.103|2-Sided|95.0||||This p-value did not meet the prespecified threshold for statistical significance of < 0.05|Chi-squared|Unadjusted||"H0: the proportion of responders in the Dermagraft group = the proportion of responders in the Control group.~HA: the proportion of responders in the Dermagraft group ≠ the proportion of responders in the Control group.~The proportion of responders in the Dermagraft group was compared with the proportion of responders in the control group using the uncorrected chi-square test for 2x2 contingency tables. The difference between the groups was expected to be 13%."|
1705649|NCT00909779|3136988|Non-Inferiority or Equivalence|"The study was powered under a one-sided alternative hypothesis, in which arformoterol is superior to placebo, with a hazard ratio of 0.80 or less. To achieve 80% power, it was necessary to observe 86 total events for the primary endpoint adjusted for interim analysis. Assuming an annual event proportion of 17.3% in the placebo group and 30% lost to follow-up, we anticipated to randomize approximately 900 subjects (450 per arm).~The non-inferiority margin for the hazard ratio is 1.4."|Hazard Ratio (HR)|0.606|||||2-Sided|95.0|0.425|0.864|||||Hazard ratio was calculated as arformoterol vs. placebo.|"The null hypothesis is: There is 40% or higher excess risk of the primary events in the arformoterol group relative to placebo (a constant hazard ratio of 1.4).~The primary analysis was a Cox proportional hazards regression model, with treatment group, baseline smoking status, sex, age, BMI, and baseline FEV1 as covariates. The hazard ratio and 90% two-sided confidence interval for the hazard ratio (adjusted for the interim analysis) comparing arformoterol to placebo were estimated."|
1705650|NCT00909753|3136989|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.5||||||90.0|85.0|96.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705869|NCT00906074|3137455|Superiority or Other|||||||0.053|||||||Chi-squared|Chi-squared Pearson||BMI(kg/mˆ2)>30|
1708387|NCT00858208|3143284|Superiority or Other|||||||0.297|||||||paired t-test|||Change at Month 6|
1705651|NCT00909753|3136990|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.4||||||90.0|83.1|98.3|||||Bioequivalence is established when 90% COnfidence Interval falls within 80-125.||
1705652|NCT00909753|3136991|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.0||||||90.0|91.3|98.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705653|NCT00909753|3136992|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|92.2||||||90.0|85.5|99.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705654|NCT00909753|3136993|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.5||||||90.0|85.5|95.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705655|NCT00909753|3136994|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.4||||||90.0|83.1|98.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705656|NCT00909753|3136995|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.5||||||90.0|92.2|98.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705657|NCT00909753|3136996|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.|Geometric Test/Ref Ratio x 100|92.5||||||90.0|85.8|99.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705658|NCT00909727|3136997|Superiority or Other||Mean Difference (Final Values)|2.8|Standard Error of the Mean|0.7||0.0002|2-Sided|95.0|1.3|4.2||P-value is for the treatment effect at Week 48 (obtained as a linear contrast of treatment at Day 336). There was no adjustment for multiple comparisons.|Mixed Models Analysis|||At Week 48: Analysis for this variable was based on a Linear Mixed Effect (LME) model with random intercept and random slope, treatment as a fixed effect, and visit (days on study) and treatment by visit interaction as random effects, with adjustment for categorical baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.|
1705659|NCT00909727|3136997|Superiority or Other||Mean Difference (Final Values)|1.9|Standard Error of the Mean|0.5||0.0004|2-Sided|95.0|0.9|2.9||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||At Week 24: Analysis for this variable was based on a Linear Mixed Effect (LME) model with dependent variable weight; treatment as a fixed effect; and intercept, visit, and treatment by visit interaction as random effects, with adjustment for baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.|
1705660|NCT00909727|3136998|Superiority or Other||Mean Difference (Final Values)|-53.5|Standard Error of the Mean|3.7|<|0.0001|2-Sided|95.0|-60.9|-46.0||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for sweat chloride and percent predicted forced expiratory volume in 1 second (FEV1), using unstructured covariance matrix.|
1705661|NCT00909727|3136998|Superiority or Other||Mean Difference (Final Values)|-54.3|Standard Error of the Mean|3.7|<|0.0001|2-Sided|95.0|-61.8|-46.8||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for sweat chloride and percent predicted forced expiratory volume in 1 second (FEV1), using unstructured covariance matrix.|
1705662|NCT00909727|3136999|Superiority or Other||Mean Difference (Final Values)|5.1|Standard Error of the Mean|3.3||0.1354|2-Sided|95.0|-1.6|11.8||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM), with the addition of the baseline domain score as a covariate.|
1705663|NCT00909727|3136999|Superiority or Other||Mean Difference (Final Values)|6.1|Standard Error of the Mean|3.7||0.1092|2-Sided|95.0|-1.4|13.5||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM), with the addition of the baseline domain score as a covariate.|
1705664|NCT00909727|3137000|Superiority or Other||Mean Difference (Final Values)|10.0|Standard Error of the Mean|2.7||0.0006|2-Sided|95.0|4.5|15.5||There was no adjustment for multiple comparisons.|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. no imputation of missing data was done.||Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint, a Mixed-Effects Model for Repeated Measures (MMRM). Estimates were obtained from MMRM with dependent variable absolute change from baseline, fixed effects for categorical visit & treatment group, & adjustment for the continuous baseline value of percent predicted FEV1, using unstructured covariance matrix.|
1705685|NCT00909545|3137015|Superiority or Other||Odds Ratio (OR)|0.3067|Standard Error of the Mean|1.1912||0.9448|2-Sided|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .|
1705730|NCT00909545|3137037|Superiority or Other||Mean Difference (Net)|-0.16|Standard Error of the Mean|0.11||0.1463|2-Sided|95.0|-0.38|0.06|||ANCOVA|||Change in Modified Hoehn & Yahr Scale of Isradipine CR 20mg/day arm is compared to placebo group.|
1705665|NCT00909727|3137001|Superiority or Other||Mean Difference (Final Values)|12.5|Standard Error of the Mean|2.9|<|0.0001|2-Sided|95.0|6.6|18.3||The primary endpoint and key secondary endpoints were tested in sequence. test 1: primary (α=0.05); test 2: using Hochberg's step-up procedure on weight (Wk 24) and sweat chloride (Wk 24)(α=0.05); test 3: CFQ-R respiratory domain score (Wk 24).|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. No imputation of missing data was done.||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit (Day 15, Week 8, Week 16, and Week 24) as fixed effects, and subject as a random effect, with adjustment for the continuous baseline value of percent predicted FEV1.|
1705666|NCT00909610|3137003|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|107.0||||||90.0|100.0|115.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705667|NCT00909610|3137004|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|101.0||||||90.0|92.2|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705668|NCT00909610|3137005|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|110.0||||||90.0|103.0|117.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705669|NCT00909610|3137006|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Mean|101.0||||||90.0|92.5|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705670|NCT00909610|3137007|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|105.0||||||90.0|100.0|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705671|NCT00909610|3137008|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|101.0||||||90.0|91.9|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705672|NCT00909610|3137009|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Ratio of the Geometric Mean|106.0||||||90.0|101.0|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705673|NCT00909610|3137010|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be applied to log-transformed AUC's and Cmax parameters.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|92.3|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125||
1705674|NCT00909545|3137011|Superiority or Other||Odds Ratio (OR)|2.2727|Standard Error of the Mean|1.2592||0.4694|2-Sided|95.0|0.1926|26.8124|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.|
1705675|NCT00909545|3137011|Superiority or Other||Odds Ratio (OR)|2.0833|Standard Error of the Mean|1.2576||0.5|2-Sided|95.0|0.1771|24.5057|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.|
1705676|NCT00909545|3137011|Superiority or Other||Odds Ratio (OR)|1.1364|Standard Error of the Mean|1.4444||0.7236|2-Sided|95.0|0.067|19.264|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Hypotension.|
1705677|NCT00909545|3137012|Superiority or Other||Odds Ratio (OR)|3.5714|Standard Error of the Mean|1.192||0.2746|2-Sided|95.0|0.3453|36.9408|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.|
1705678|NCT00909545|3137012|Superiority or Other||Odds Ratio (OR)|2.0833|Standard Error of the Mean|1.2576||0.5|2-Sided|95.0|0.1771|24.5057|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Back Pain.|
1705679|NCT00909545|3137013|Superiority or Other||Odds Ratio (OR)|0.3067|Standard Error of the Mean|1.1912||0.9448|2-Sided|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.|
1705680|NCT00909545|3137013|Superiority or Other||Odds Ratio (OR)|0.7302|Standard Error of the Mean|0.9616||0.7852|2-Sided|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Sinusitis.|
1705681|NCT00909545|3137014|Superiority or Other||Odds Ratio (OR)|0.5217|Standard Error of the Mean|1.2594||0.8673|2-Sided|95.0|0.0442|6.1537|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.|
1705682|NCT00909545|3137014|Superiority or Other||Odds Ratio (OR)|1.0|Standard Error of the Mean|1.0409||0.6951|2-Sided|95.0|0.13|7.6906|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.|
1705683|NCT00909545|3137014|Superiority or Other||Odds Ratio (OR)|0.5455|Standard Error of the Mean|1.2596||0.8589|2-Sided|95.0|0.0462|6.4433|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Diarrhoea.|
1705684|NCT00909545|3137015|Superiority or Other||Odds Ratio (OR)|0.3333|Standard Error of the Mean|1.1924||0.9351|2-Sided|95.0|0.0322|3.4459|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .|
1705729|NCT00909545|3137036|Superiority or Other||Mean Difference (Net)|-0.52|Standard Error of the Mean|1.4||0.7111|2-Sided|95.0|-3.3|2.26|||ANCOVA|||Change in Modified Schwab & England Independence Scale of Isradipine CR 5mg/day arm is compared to placebo group.|
1705686|NCT00909545|3137015|Superiority or Other||Odds Ratio (OR)|0.3485|Standard Error of the Mean|1.1919||0.9294|2-Sided|95.0|0.0337|3.6084|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dyspepsia .|
1705687|NCT00909545|3137016|Superiority or Other||Odds Ratio (OR)|0.5217|Standard Error of the Mean|1.2594||0.8673|2-Sided|95.0|0.0442|6.1537|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .|
1705688|NCT00909545|3137016|Superiority or Other||Odds Ratio (OR)|0.48|Standard Error of the Mean|1.2577||0.8824|2-Sided|95.0|0.0408|5.6461|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .|
1705689|NCT00909545|3137016|Superiority or Other||Odds Ratio (OR)|1.8|Standard Error of the Mean|0.9617||0.4402|2-Sided|95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Insomnia .|
1705690|NCT00909545|3137017|Superiority or Other||Odds Ratio (OR)|1.0|Standard Error of the Mean|1.0409||0.6951|2-Sided|95.0|0.13|7.6906|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.|
1705691|NCT00909545|3137017|Superiority or Other||Odds Ratio (OR)|1.8|Standard Error of the Mean|0.9617||0.4402|2-Sided|95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Somnolence.|
1705692|NCT00909545|3137018|Superiority or Other||Odds Ratio (OR)|1.0909|Standard Error of the Mean|1.0428||0.6641|2-Sided|95.0|0.1413|8.4197|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.|
1705693|NCT00909545|3137018|Superiority or Other||Odds Ratio (OR)|0.48|Standard Error of the Mean|1.2577||0.8824|2-Sided|95.0|0.0408|5.6461|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.|
1705694|NCT00909545|3137018|Superiority or Other||Odds Ratio (OR)|1.8|Standard Error of the Mean|0.9617||0.4402||95.0|0.2733|11.8558|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Depression.|
1705695|NCT00909545|3137019|Superiority or Other||Odds Ratio (OR)|5.9524|Standard Error of the Mean|1.1347||0.0953|2-Sided|95.0|0.6439|55.0272|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.|
1705696|NCT00909545|3137019|Superiority or Other||Odds Ratio (OR)|2.381|Standard Error of the Mean|1.2599||0.4532|2-Sided|95.0|0.2015|28.1366|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Tract Infection.|
1705697|NCT00909545|3137020|Superiority or Other||Odds Ratio (OR)|0.697|Standard Error of the Mean|0.9604||0.7996|2-Sided|95.0|0.1061|4.5779|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.|
1705698|NCT00909545|3137020|Superiority or Other||Odds Ratio (OR)|0.3067|Standard Error of the Mean|1.1912||0.9448|2-Sided|95.0|0.0297|3.1612|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.|
1705699|NCT00909545|3137020|Superiority or Other||Odds Ratio (OR)|0.7302|Standard Error of the Mean|0.9616||0.7852|2-Sided|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nausea.|
1705700|NCT00909545|3137021|Superiority or Other||Odds Ratio (OR)|1.7143|Standard Error of the Mean|0.9605||0.4609|2-Sided|95.0|0.2609|11.2639|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.|
1705701|NCT00909545|3137021|Superiority or Other||Odds Ratio (OR)|1.5652|Standard Error of the Mean|0.9584||0.5|2-Sided|95.0|0.2392|10.241|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.|
1705702|NCT00909545|3137021|Superiority or Other||Odds Ratio (OR)|0.5455|Standard Error of the Mean|1.2596||0.8589|2-Sided|95.0|0.0462|6.4433|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Fatigue.|
1705703|NCT00909545|3137022|Superiority or Other||Odds Ratio (OR)|1.5333|Standard Error of the Mean|0.8227||0.4534|2-Sided|95.0|0.3057|7.6897|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.|
1705704|NCT00909545|3137022|Superiority or Other||Odds Ratio (OR)|1.0|Standard Error of the Mean|0.8681||0.666|2-Sided|95.0|0.1824|5.482|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.|
1705705|NCT00909545|3137022|Superiority or Other||Odds Ratio (OR)|0.7302|Standard Error of the Mean|0.9616||0.7852|2-Sided|95.0|0.1109|4.8065|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Constipation.|
1705706|NCT00909545|3137023|Superiority or Other||Odds Ratio (OR)|1.5333|Standard Error of the Mean|0.8227||0.4534|2-Sided|95.0|0.3057|7.6897|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.|
1705707|NCT00909545|3137023|Superiority or Other||Odds Ratio (OR)|2.3|Standard Error of the Mean|0.7704||0.2327|2-Sided|95.0|0.5081|10.4105|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.|
1705708|NCT00909545|3137023|Superiority or Other||Odds Ratio (OR)|1.15|Standard Error of the Mean|0.8719||0.6049|2-Sided|95.0|0.2082|6.3508|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Headache.|
1705709|NCT00909545|3137024|Superiority or Other||Odds Ratio (OR)|2.4|Standard Error of the Mean|0.9174||0.2953|2-Sided|95.0|0.3975|14.4919|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.|
1705710|NCT00909545|3137024|Superiority or Other||Odds Ratio (OR)|4.4211|Standard Error of the Mean|0.8584||0.07|2-Sided|95.0|0.8217|23.7875|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.|
1705711|NCT00909545|3137024|Superiority or Other||Odds Ratio (OR)|2.5263|Standard Error of the Mean|0.9188||0.2756|2-Sided|95.0|0.4172|15.2975|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Nasopharyngitis.|
1705712|NCT00909545|3137025|Superiority or Other||Odds Ratio (OR)|0.9048|Standard Error of the Mean|0.6463||0.6823|2-Sided|95.0|0.2549|3.2112|||Fisher Exact|||One-sided Fisher's exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.|
1705713|NCT00909545|3137025|Superiority or Other||Odds Ratio (OR)|0.8143|Standard Error of the Mean|0.6419||0.7385|2-Sided|95.0|0.2314|2.8658|||Fisher Exact|||one-sided Fisher's exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.|
1705714|NCT00909545|3137025|Superiority or Other||Odds Ratio (OR)|0.754|Standard Error of the Mean|0.6715||0.7735|2-Sided|95.0|0.2022|2.812|||Fisher Exact|||one-sided Fisher's exact test will be used to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Dizziness.|
1705715|NCT00909545|3137026|Superiority or Other||Odds Ratio (OR)|50.0|Standard Error of the Mean|1.108|<|0.0001|2-Sided|95.0|5.7004|438.5694||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||Fisher’s exact test will be used to compare Isradipine CR 20mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.|
1705716|NCT00909545|3137026|Superiority or Other||Odds Ratio (OR)|15.625|Standard Error of the Mean|1.097|<|0.0024|2-Sided|95.0|1.8214|134.0403||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher’s exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||Fisher’s exact test will be used to compare Isradipine CR 10mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.|
1705717|NCT00909545|3137026|Superiority or Other||Odds Ratio (OR)|5.2632|Standard Error of the Mean|1.159|<|0.1384|2-Sided|95.0|0.5432|50.9977||The analysis of common AE of each active dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher’s exact tests. No adjustment will be made for multiple comparisons in these analyses.|Fisher Exact|||The analyses is to compare Isradipine CR 5mg group to the placebo group with regard to the proportion of subjects experiencing the adverse event of Oedema Peripheral.|
1705718|NCT00909545|3137033|Superiority or Other||Mean Difference (Net)|2.07|Standard Error of the Mean|1.83||0.26|2-Sided|95.0|-1.56|5.71|||ANCOVA|||Change in PDQ-39 of Isradipine CR 20mg/day arm is compared to placebo group.|
1705719|NCT00909545|3137033|Superiority or Other||Mean Difference (Net)|1.72|Standard Error of the Mean|1.86||0.356|2-Sided|95.0|-1.97|5.42|||ANCOVA|||Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.|
1705720|NCT00909545|3137033|Superiority or Other||Mean Difference (Net)|2.19|Standard Error of the Mean|1.8||0.2278|2-Sided|95.0|-1.4|5.79|||ANCOVA|||Change in PDQ-39 of Isradipine CR 5mg/day arm is compared to placebo group.|
1705721|NCT00909545|3137034|Superiority or Other||Mean Difference (Net)|-0.22|Standard Error of the Mean|0.57||0.7049|2-Sided|95.0|-1.36|0.92|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 20mg/day arm is compared to placebo group.|
1705722|NCT00909545|3137034|Superiority or Other||Mean Difference (Net)|-0.47|Standard Error of the Mean|0.56||0.4045|2-Sided|95.0|-1.59|0.65|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 10mg/day arm is compared to placebo group.|
1705723|NCT00909545|3137034|Superiority or Other||Mean Difference (Net)|-0.52|Standard Error of the Mean|0.56||0.3533|2-Sided|95.0|-1.64|0.59|||ANCOVA|||Change in Montreal Cognitive Assessment of Isradipine CR 5mg/day arm is compared to placebo group.|
1705724|NCT00909545|3137035|Superiority or Other||Mean Difference (Net)|2.02|Standard Error of the Mean|1.52||0.1336|2-Sided|95.0|-0.63|4.67|||ANCOVA|||Change in BDI-II of Isradipine CR 20mg/day arm is compared to placebo group.|
1705725|NCT00909545|3137035|Superiority or Other||Mean Difference (Net)|0.63|Standard Error of the Mean|1.36||0.6445|2-Sided|95.0|-2.07|3.33|||ANCOVA|||Change in BDI-II of Isradipine CR 10mg/day arm is compared to placebo group.|
1705726|NCT00909545|3137035|Superiority or Other||Mean Difference (Net)|2.5|Standard Error of the Mean|1.32||0.0608|2-Sided|95.0|-0.12|5.13|||ANCOVA|||Change in BDI-II of Isradipine CR 5mg/day arm is compared to placebo group.|
1705727|NCT00909545|3137036|Superiority or Other||Mean Difference (Net)|1.27|Standard Error of the Mean|1.4||0.3658|2-Sided|95.0|-1.51|4.05|||ANCOVA|||Change in Modified Schwab & England Independence Scale of Isradipine CR 20mg/day arm is compared to placebo group.|
1705728|NCT00909545|3137036|Superiority or Other||Mean Difference (Net)|1.35|Standard Error of the Mean|1.36||0.3237|2-Sided|95.0|-1.35|4.04|||ANCOVA|||Change in Modified Schwab & England Independence Scale of Isradipine CR 10mg/day arm is compared to placebo group.|
1705731|NCT00909545|3137037|Superiority or Other||Mean Difference (Net)|-0.15|Standard Error of the Mean|0.11||0.1755|2-Sided|95.0|-0.36|0.07|||ANCOVA|||Change in Modified Hoehn & Yahr Scale of Isradipine CR 10mg/day arm is compared to placebo group.|
1705732|NCT00909545|3137037|Superiority or Other||Mean Difference (Net)|-0.05|Standard Error of the Mean|0.11||0.6677|2-Sided|95.0|-0.27|0.17|||ANCOVA|||Change in Modified Hoehn & Yahr Scale of Isradipine CR 5mg/day arm is compared to placebo group.|
1705733|NCT00909545|3137038|Superiority or Other||Mean Difference (Net)|-0.64|Standard Error of the Mean|1.48||0.669|2-Sided|95.0|-3.58|2.31|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.|
1705734|NCT00909545|3137038|Superiority or Other||Mean Difference (Net)|-0.41|Standard Error of the Mean|1.46||0.7778|2-Sided|95.0|-3.3|2.48|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.|
1705735|NCT00909545|3137038|Superiority or Other||Mean Difference (Net)|-0.83|Standard Error of the Mean|1.5||0.579|2-Sided|95.0|-3.8|2.14|||ANCOVA|||Change in Motor UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.|
1705736|NCT00909545|3137039|Superiority or Other||Mean Difference (Net)|-0.74|Standard Error of the Mean|0.81||0.3674|2-Sided|95.0|-2.36|0.88|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.|
1705737|NCT00909545|3137039|Superiority or Other||Mean Difference (Net)|-0.51|Standard Error of the Mean|0.8||0.525|2-Sided|95.0|-2.09|1.07|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.|
1705738|NCT00909545|3137039|Superiority or Other||Mean Difference (Net)|0.6|Standard Error of the Mean|0.82||0.4648|2-Sided|95.0|-1.03|2.23|||ANCOVA|||Change in ADL UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.|
1705739|NCT00909545|3137040|Superiority or Other||Mean Difference (Net)|-0.27|Standard Error of the Mean|0.37||0.4675|2-Sided|95.0|-1.02|0.47|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 20mg/day arm is compared to placebo group.|
1705740|NCT00909545|3137040|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.37||1|2-Sided|95.0|-0.73|0.73|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 10mg/day arm is compared to placebo group.|
1705741|NCT00909545|3137040|Superiority or Other||Mean Difference (Net)|0.46|Standard Error of the Mean|0.38||0.2324|2-Sided|95.0|-0.3|1.22|||ANCOVA|||Change in Mental UPDRS subscale of Isradipine CR 5mg/day arm is compared to placebo group.|
1705742|NCT00909545|3137041|Superiority or Other||Odds Ratio (OR)|0.024|Standard Error of the Mean|1.1035|<|0.0001|2-Sided|95.0|0.0028|0.2087|||Fisher Exact|||The tolerability of 20mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher's exact tests. No adjustment will be made for multiple comparisons in these analyses.|
1705743|NCT00909545|3137041|Superiority or Other||Odds Ratio (OR)|0.1086|Standard Error of the Mean|0.1114|<|0.0248|2-Sided|95.0|0.0123|0.9591|||Fisher Exact|||The tolerability of 10mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher’s exact tests. No adjustment will be made for multiple comparisons in these analyses.|
1705744|NCT00909545|3137041|Superiority or Other||Odds Ratio (OR)|0.19|Standard Error of the Mean|1.1587|<|0.1383|2-Sided|95.0|0.0196|1.8411|||Fisher Exact|||The tolerability of 5mg/day dosage of isradipine CR will be compared with that of the placebo group using one-sided Fisher’s exact tests. No adjustment will be made for multiple comparisons in these analyses.|
1705745|NCT00909545|3137042|Superiority or Other||Mean Difference (Net)|-2.0|Standard Error of the Mean|2.01||0.322|2-Sided|95.0|-5.98|1.99||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 20mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 20mg/day arm is compared to placebo group.|
1705746|NCT00909545|3137042|Superiority or Other||Mean Difference (Net)|-1.1|Standard Error of the Mean|1.97||0.5761|2-Sided|95.0|-5.01|2.8||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 10mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 10mg/day arm is compared to placebo group.|
1705747|NCT00909545|3137042|Superiority or Other||Mean Difference (Net)|0.04|Standard Error of the Mean|2.03||0.9834|2-Sided|95.0|-3.99|4.07||P-values for efficacy outcomes will be one-sided test with alpha = 0.05|ANCOVA|Analysis of covariance is used, with terms representing assigned treatment group and baseline value of the measure in the model.|Least square mean(standard error) and 95% confidence intervals of the difference between Isradipine CR 5mg and placebo groups is estimated.|Change in UPDRS total score of Isradipine CR 5mg/day arm is compared to placebo group.|
1705748|NCT00909532|3137043|Superiority or Other||Mean Difference (Final Values)|2.7|Standard Error of the Mean|0.7||0.0001|2-Sided|95.0|1.3|4.1||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg’s step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05).|Mixed Models Analysis|||At Week 48: Analysis for this variable was based on a linear mixed effects (LME) model with treatment as a fixed effect and visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group and baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.|
1705749|NCT00909532|3137043|Superiority or Other||Mean Difference (Final Values)|2.8|Standard Error of the Mean|0.5|<|0.0001|2-Sided|95.0|1.8|3.7|||Mixed Models Analysis|There was no adjustment for multiple comparisons.||At Week 24: Analysis for this variable was based on a linear mixed effects (LME) model with treatment as a fixed effect, and intercept, visit (days on study) and treatment by visit interaction as random effects, with adjustment for age group and baseline percent predicted forced expiratory volume in 1 second (FEV1) severity.|
1705750|NCT00909532|3137044|Superiority or Other||Cox Proportional Hazard at 48 Weeks|0.46||||0.0012|2-Sided|95.0|0.28|0.73||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg’s step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05); test 3 using Hochberg’s on time to pulmonary exacerbation (Wk 48) and weight (Wk 48).|Regression, Cox|||Time to first pulmonary exacerbation through Week 48 was analyzed using Cox regression. The model included a covariate for treatment and adjustments for the age group and percent predicted forced expiratory volume in 1 second (FEV1) severity at baseline.|
1705751|NCT00909532|3137044|Superiority or Other||Cox Proportional Hazard at Week 24|0.4||||0.0016|2-Sided|95.0|0.23|0.71||There was no adjustment for multiple comparisons.|Regression, Cox|||Time to first pulmonary exacerbation through Week 24 was analyzed using Cox regression. The model included a covariate for treatment and adjustments for the age group and percent predicted forced expiratory volume in 1 second (FEV1) severity at baseline.|
1705752|NCT00909532|3137045|Superiority or Other||Mean Difference (Final Values)|-48.1|Standard Error of the Mean|1.7|<|0.0001|2-Sided|95.0|-51.5|-44.7||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, sweat chloride, and percent predicted FEV1, using unstructured covariance matrix.|
1705753|NCT00909532|3137045|Superiority or Other||Mean Difference (Final Values)|-47.9|Standard Error of the Mean|1.7|<|0.0001|2-Sided|95.0|-51.3|-44.5||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg’s step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05); test 3 using Hochberg’s on time to pulmonary exacerbation (Wk 48) and weight (Wk 48).|Mixed Models Analysis|||Through Week 24: Analysis for this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, sweat chloride, and percent predicted FEV1, using unstructured covariance matrix.|
1705754|NCT00909532|3137046|Superiority or Other||Mean Difference (Final Values)|8.6|Standard Error of the Mean|1.7|<|0.0001|2-Sided|95.0|5.3|11.9||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Through Week 48: Analysis for the CFQ-R respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from MMRM with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age,sweat chloride, and percent predicted FEV1,using unstructured covariance matrix.|
1705755|NCT00909532|3137046|Superiority or Other||Mean Difference (Final Values)|8.1|Standard Error of the Mean|1.7|<|0.0001|2-Sided|95.0|4.7|11.4||Analyzed in sequence: test 1, primary (α=0.05); test 2, using Hochberg’s step-up procedure on CFQ-R resp domain(Wk 24) and sweat chloride (Wk 24) (α=0.05).|Mixed Models Analysis|||Through Week 24: Analysis for the respiratory domain score endpoint was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for continuous baseline value for age, domain score, and percent predicted FEV1, using unstructured covariance matrix.|
1705756|NCT00909532|3137047|Superiority or Other||Mean Difference (Final Values)|10.5|Standard Error of the Mean|1.0|<|0.0001|2-Sided|95.0|8.5|12.5||There was no adjustment for multiple comparisons.|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation. No imputation of missing data was done.||Analysis of this variable was similar to that of the primary analysis of the primary efficacy endpoint. Estimates were obtained from Mixed-Effects Model for Repeated Measures (MMRM) with dependent variable absolute change from baseline, fixed effects for categorical visit and treatment group, and adjustment for the continuous baseline values of age and percent predicted forced expiratory volume in 1 second (FEV1),using unstructured covariance matrix.|
1705757|NCT00909532|3137048|Superiority or Other||Mean Difference (Final Values)|10.6|Standard Error of the Mean|1.0|<|0.0001|2-Sided|95.0|8.6|12.6||The primary and key secondary endpoints were analyzed using Hochberg’s step-up procedure: test 1, primary (α=0.05); test 2, CFQ-R resp domain (Wk24) and sweat chloride (Wk24)(α=0.05).|Mixed Models Analysis|Denominator degrees of freedom were estimated using the Kenward-Roger approximation.||The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit (Day 15, Week 8, Week 16, and Week 24) as fixed effects, and subject as a random effect, with adjustment for the continuous baseline values of age and percent predicted FEV1.|
1705758|NCT00909480|3137062|Non-Inferiority or Equivalence|Non-inferiority margin: 0.4%.|Mean Difference (Net)|0.3003||||||95.0|0.1427|0.458|||||||
1705759|NCT00909428|3137063|Superiority||Z-Score|2.803||||0.005|2-Sided||||||Wilcoxon signed rank test|||The null hypothesis is that there is no change from baseline maximal tolerated cystometric capacity following 30 days of treatment with daily 10mg solifenacin succinate.|
1705760|NCT00909220|3137072|Other|Hierarchical linear modeling (HLM) , an ordinary least square (OLS) regression-based analysis.|Slope|2.58|Standard Error of the Mean|0.75|<|0.05|2-Sided|95.0|1.22|2.77||The variation of slopes among participants for each variable were calculated. If significant, a second level of analysis focused on predictors of the variation was conducted.|Regression, Logistic|df = 31||A two-level hierarchical linear model assessing the effects of negativity bias and positivity offset at pre-treatment on the rate of depression severity (IDS-SR) over 16 weeks of treatment (time). First level units were 'weeks in BA treatment', with participants limited to those who attended five or more therapy sessions, resulting in a total of 421 treatment weeks for analysis. Second-level units were the 'subjects entering BA treatment'.|
1705761|NCT00909220|3137073|Other|Multiple regression analyses|beta|0.43|Standard Error of the Mean|6.75||0.02|2-Sided|||||p <0.05 a priori threshold for statistical significance.|Regression, Linear||||
1705762|NCT00909220|3137074|Superiority|ANCOVA|Mean Difference (Final Values)|0.39|Standard Error of the Mean|0.07|<|0.05|2-Sided|95.0|0.31|0.59|||ANCOVA|||ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-SR score at week 0) to estimate depression at the end of treatment (IDS-SR score at week 16).|
1705763|NCT00909220|3137075|Superiority||Mean Difference (Final Values)|0.42|Standard Error of the Mean|0.06||0.05|2-Sided|95.0|0.27|0.49|||ANCOVA|||ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-C score at week 0) to estimate depression at the end of treatment (IDS-C score at week 16).|
1705764|NCT00908960|3137090|Superiority or Other||Hazard Ratio (HR)|6.7||||0.06|2-Sided|95.0|1.03|43.17|||Fine and Gray regression||||
1705765|NCT00908895|3137113|Superiority or Other||Cox Proportional Hazard|90.0|Standard Deviation|10.0|<|0.05||95.0|80.0|100.0|||Chi-squared||||
1705766|NCT00908895|3137114|Superiority or Other||Cox Proportional Hazard|70.0|Standard Deviation|25.0|<|0.05||95.0|||||Chi-squared|||We assess that 15% is a significative strength difference. According to a 80% study power, a SD at 25% and a 20% lost to follow-up, we found 118 patients for the all study.|
1705767|NCT00908791|3137128|Superiority or Other||||||>|0.05|||||||Other||||
1705768|NCT00908791|3137129|Superiority or Other||||||>|0.05|||||||Other||||
1705769|NCT00908791|3137130|Superiority or Other|||||||0.62|||||||t-test, 2 sided||||
1705770|NCT00908791|3137131|Superiority or Other|||||||0.029|||||||Sign test|||The Sign-Rank test for paired data.|
1705771|NCT00908791|3137132|Superiority or Other|||||||0.48|||||||bowker's test of symmetry||||
1705772|NCT00908791|3137133|Superiority or Other|||||||0.41|||||||McNemar||||
1705773|NCT00908791|3137134|Superiority or Other|||||||0.003|||||||McNemar|exact McNemar test for paired binary data.|||
1705774|NCT00908544|3137168|Other|Changes (within PHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 84.|Mean Difference (Final Values)|-1.7|||<|0.01|2-Sided|95.0|-2.0|-1.4|||t-test, 1 sided||||
1705775|NCT00908544|3137168|Other|Changes (within CHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 84.|Mean Difference (Final Values)|0.2|||<|0.97|2-Sided|95.0|0.0|0.3|||t-test, 1 sided||||
1705776|NCT00908544|3137168|Other|Changes (within PHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 36.|Mean Difference (Final Values)|-1.7|||<|0.01|2-Sided|95.0|-2.0|-1.5|||t-test, 1 sided||||
1705777|NCT00908544|3137168|Other|Changes (within CHI Group) in HIV DNA in CD4+T cells from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at month 36.|Mean Difference (Final Values)|0.2|||<|0.99|2-Sided|95.0|0.0|0.4|||t-test, 1 sided||||
1705778|NCT00908544|3137169|Other|Changes (within PHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 84.|Mean Difference (Final Values)|-1.3|||<|0.01|2-Sided|95.0|-1.6|-1.0|||t-test, 1 sided||||
1705779|NCT00908544|3137169|Other|Changes (within CHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 84.|Mean Difference (Final Values)|0.12|||<|0.93|2-Sided|95.0|-0.1|0.3|||t-test, 1 sided||||
1705780|NCT00908544|3137169|Other|Changes (within PHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 36.|Mean Difference (Final Values)|-1.4|||<|0.01|2-Sided|95.0|-1.7|-1.1|||t-test, 1 sided||||
1705781|NCT00908544|3137169|Other|Changes (within CHI group) in HIV DNA in PBMC from Baseline (BL) will be tested for statistical significance using one-tailed paired t-test or Wilcoxon signed rank test as appropriate on distribution of data at months 36.|Mean Difference (Final Values)|0.2|||<|0.98|2-Sided|95.0|0.0|0.4|||t-test, 1 sided||||
1705782|NCT00908388|3137177|Superiority or Other|||||||0.006||||||(1-Posterior probability of meeting performance goal given the data)|Bayesian adaptive||||
1705783|NCT00908375|3137178|Superiority or Other||Median Difference (Final Values)|-16.0||||0.139|2-Sided|99.0|-42.0|16.0||The criterion for rejection of the null hypothesis (P < 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.|Wilcoxon (Mann-Whitney)||||
1705784|NCT00908375|3137179|Superiority or Other||Median Difference (Final Values)|-1.0||||0.282|2-Sided|99.0|-2.0|1.0||The criterion for rejection of the null hypothesis (P < 0.05) was adjusted for multiple applications of the test to the same data using the Bonferroni correction.|Wilcoxon (Mann-Whitney)||||
1705785|NCT00908375|3137180|Non-Inferiority or Equivalence|Sample size was determined based on the primary outcome variable, the VAS pain score at three weeks. Based on the results of the study of Siddall et al., group sample sizes of 19 and 19 achieve 82% power to detect a difference of 2.00 between the null hypothesis that both group means are 6.50 and the alternative hypothesis that the mean of pregabalin group is 4.50 with estimated group standard deviations of 2.10 and 2.10 and with a significance level of 0.05 using a two-sided two-sample t-test.|Median Difference (Final Values)|-2.0||||0.279|2-Sided|99.0|-6.0|3.0||The criterion for rejection of the null hypothesis (P < 0.05) was adjusted for multiple application of the test to the same data set using the Bonferroni correction.|Wilcoxon (Mann-Whitney)||||
1705786|NCT00908128|3137190|Non-Inferiority or Equivalence|Analyses of Variance (PROC MIXED) was performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|98.78||||||90.0|95.76|101.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705787|NCT00908128|3137191|Non-Inferiority or Equivalence|Analyses of Variance (PROC MIXED) was performed on log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|99.16||||||90.0|96.24|102.16|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705788|NCT00908128|3137192|Non-Inferiority or Equivalence|Analyses of Variance (PROC MIXED) was performed on lon-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|90.96||||||90.0|82.4|100.41|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705789|NCT00907907|3137240|Non-Inferiority or Equivalence|Analyses of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|99.91||||||90.0|95.99|103.98|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705790|NCT00907907|3137241|Non-Inferiority or Equivalence|Analyses of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|102.01||||||90.0|98.74|105.39|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705865|NCT00906074|3137455|Superiority or Other|||||||0.637|||||||Chi-squared|Chi-squared Pearson||Malnutrition (hypoalbuminemia)|
1705866|NCT00906074|3137455|Superiority or Other|||||||0.169|||||||Chi-squared|Chi-squared Pearson||Anemia (Hb<9gr/dL)|
1705791|NCT00907907|3137242|Non-Inferiority or Equivalence|Analysis of Variance (PROC MIXED) were performed on the log-transformed AUCt, AUCinf and Cmax parameters.|Geometric Test/Ref Ratio x 100|93.97||||||90.0|80.25|110.04|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705792|NCT00907881|3137246|Superiority or Other|||||||0.0002|||||||Regression, Linear|Pearson correlation coefficient|||
1705793|NCT00907296|3137293|Superiority||Hazard Ratio (HR)|1.04||||0.8488|2-Sided|95.0|0.68|1.59|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705794|NCT00907296|3137293|Superiority||Hazard Ratio (HR)|1.34||||0.1864|2-Sided|95.0|0.87|2.07|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705795|NCT00907296|3137293|Superiority||Hazard Ratio (HR)|1.14||||0.5578|2-Sided|95.0|0.74|1.75|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705796|NCT00907296|3137293|Superiority||Hazard Ratio (HR)|1.17||||0.4754|2-Sided|95.0|0.76|1.81|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705797|NCT00907296|3137293|Superiority||Hazard Ratio (HR)|0.8||||0.3225|2-Sided|95.0|0.52|1.24|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705798|NCT00907296|3137293|Superiority||Hazard Ratio (HR)|0.68||||0.0844|2-Sided|95.0|0.44|1.05|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705799|NCT00907296|3137293|Superiority||Hazard Ratio (HR)|1.27||||0.295|2-Sided|95.0|0.81|1.97|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705800|NCT00907296|3137293|Superiority||Hazard Ratio (HR)|1.0||||0.9958|2-Sided|95.0|0.65|1.53|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705801|NCT00907296|3137293|Superiority||Hazard Ratio (HR)|0.73||||0.1713|2-Sided|95.0|0.47|1.14|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705802|NCT00907296|3137296|Superiority||Hazard Ratio (HR)|1.0||||0.9952|2-Sided|95.0|0.65|1.53|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705803|NCT00907296|3137296|Superiority||Hazard Ratio (HR)|1.18||||0.4779|2-Sided|95.0|0.75|1.84|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705804|NCT00907296|3137296|Superiority||Hazard Ratio (HR)|1.11||||0.6204|2-Sided|95.0|0.73|1.7|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705805|NCT00907296|3137296|Superiority||Hazard Ratio (HR)|0.92||||0.7197|2-Sided|95.0|0.6|1.42|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1709132|NCT00852995|3144526|Superiority or Other|||||||0.027||||||Week 12|Cochran-Mantel-Haenszel||||
1705806|NCT00907296|3137296|Superiority||Hazard Ratio (HR)|0.97||||0.8819|2-Sided|95.0|0.63|1.49|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705807|NCT00907296|3137296|Superiority||Hazard Ratio (HR)|0.9||||0.6276|2-Sided|95.0|0.59|1.37|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705808|NCT00907296|3137296|Superiority||Hazard Ratio (HR)|1.0||||0.9958|2-Sided|95.0|0.64|1.58|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705809|NCT00907296|3137296|Superiority||Hazard Ratio (HR)|0.91||||0.6544|2-Sided|95.0|0.59|1.39|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705810|NCT00907296|3137296|Superiority||Hazard Ratio (HR)|0.82||||0.3598|2-Sided|95.0|0.53|1.26|||Cox proportional hazard model||A hazard ratio > 1 favors romosozumab.|The cause-specific hazard was modeled using a Cox proportional hazards model with 10 treatment groups as the independent variable, stratified by type of fracture and definitive fracture fixation (closed with reamed IM nail, Gustilo type I/II open with reamed IM nail, Gustilo type I/II open with unreamed IM nail) and adjusting for quality of surgical fixation.|
1705811|NCT00907153|3137307|Superiority||Mean Difference (Net)|-7.84||||0.46|2-Sided|95.0|-29.34|13.67|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705812|NCT00907153|3137308|Superiority||Mean Difference (Net)|1.56||||0.38|2-Sided|95.0|-2.08|5.2|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705813|NCT00907153|3137309|Superiority||Mean Difference (Net)|44.31|||<|0.001|2-Sided|95.0|27.13|61.48|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705814|NCT00907153|3137310|Superiority||Mean Difference (Net)|-3.15||||0.25|2-Sided|95.0|-8.7|2.41|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705815|NCT00907153|3137311|Superiority||Mean Difference (Net)|0.88||||0.88|2-Sided|95.0|-22.81|8.51|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705816|NCT00907153|3137312|Superiority||Mean Difference (Net)|10.24||||0.64|2-Sided|95.0|-34.61|55.08|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705817|NCT00907153|3137313|Superiority||Mean Difference (Net)|0.28||||0.98|2-Sided|95.0|-20.29|20.85|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705818|NCT00907153|3137314|Superiority||Median Difference (Net)|-1.93||||0.62|2-Sided|95.0|-10.12|6.26|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705819|NCT00907153|3137315|Superiority||Mean Difference (Net)|0.11||||0.99|2-Sided|95.0|-24.43|24.64|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705820|NCT00907153|3137316|Superiority||Mean Difference (Net)|3.08||||0.21|2-Sided|95.0|-1.84|7.99|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705821|NCT00907153|3137317|Superiority||Mean Difference (Net)|0.73||||0.96|2-Sided|95.0|-32.59|34.06|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705822|NCT00907153|3137318|Superiority||Mean Difference (Net)|-75.08||||0.09|2-Sided|95.0|-161.9|11.78|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705823|NCT00907153|3137319|Superiority||Mean Difference (Net)|-12.8||||0.39|2-Sided|95.0|-42.94|17.34|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705824|NCT00907153|3137320|Superiority||Mean Difference (Net)|13.84||||0.33|2-Sided|95.0|-210.29|37.98|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705825|NCT00907153|3137321|Superiority||Mean Difference (Net)|6.28||||0.22|2-Sided|95.0|-3.97|16.54|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705826|NCT00907153|3137322|Superiority||Mean Difference (Net)|-6.51||||0.02|2-Sided|95.0|-12.07|-0.96|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705827|NCT00907153|3137323|Superiority||Mean Difference (Net)|-3.65||||0.48|2-Sided|95.0|-14.32|7.02|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705828|NCT00907153|3137324|Superiority||Mean Difference (Net)|-1.14||||0.62|2-Sided|95.0|-5.89|3.62|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705829|NCT00907153|3137325|Superiority||Mean Difference (Net)|-0.017||||0.05|2-Sided|95.0|-0.034|0.0|||Regression, Linear|Model-based differences adjusted for oral contraceptive use and season.|||
1705830|NCT00907088|3137333|Superiority or Other|||||||0.42|||||||Chi-squared||||
1705831|NCT00906971|3137334|Non-Inferiority or Equivalence|Statistical analysis to compare the two groups at the end of the follow-up period with regard to the primary outcome measures was blind, by intention-to-treat, considering loss of follow-up as treatment failure. In such cases, at the end of the follow-up period, the frequency of fecal incontinence was recorded reported at the beginning of the study|||||>|0.05|||||||t-test, 1 sided|The Mann-Whitney test was used for numerical variables with non-normal distribution.|||
1705832|NCT00906971|3137335|Non-Inferiority or Equivalence|Statistical analysis to compare the two groups at the end of the follow-up period with regard to the primary outcome measures was blind, by intention-to-treat, considering loss of follow-up as treatment failure. In such cases, at the end of the follow-up period, the frequency of defecations was recorded.|||||<|0.05|||||||t-test, 1 sided|The Mann-Whitney test was used for numerical variables with non-normal distribution.|||
1705833|NCT00906789|3137353|Non-Inferiority or Equivalence|Given a continuous confidence score (0-100), the trapezoidal method was used to obtain the area under the LROC with bootstrapping at 10,000 iterations to obtain the 95% confidence interval (CI). Acceptance criteria for tests of non-inferiority and superiority were previously set at 95% CI upper bound of ΔAUCUA-SV less than δ=0.1 and δ=0, respectively. If the 95% CI upper bound difference of UA-SV is less than 0.1, then SV is non-inferior. If it is 0 or less than 0, then SV is superior.||||||0.05|||||||Bootstraping|||The sample size of 351 patients, in a 2:1 ratio of nodule absent to present patients was selected to provide 80% power to detect a difference in areas under the curve of 0.10 or greater. This sample size was calculated using PASS software (Hintze, 2008). Settings: • α = 0.025. • one-sided test • AUCA = 0.80 and AUCSV = 0.90.• 2:1 ratio of patients with nodules to those without • areas calculated for the entire curves • correlation 0.3* • discrete data. • standard deviation ratios of 1*.|
1705834|NCT00906698|3137362|Superiority or Other||Ratio of adjusted gMean|81.7|||||2-Sided|90.0|60.47|110.369|||||||
1705835|NCT00906698|3137363|Superiority or Other||Ratio of adjusted gMean|83.86|||||2-Sided|95.0|66.369|105.966|||||||
1705836|NCT00906698|3137364|Superiority or Other||Ratio of adjusted gMean|76.75|||||2-Sided|90.0|56.71|103.871|||||||
1705837|NCT00906698|3137365|Superiority or Other||Ratio of adjusted gMean|90.21|||||2-Sided|90.0|76.071|106.978|||||||
1705838|NCT00906698|3137368|Superiority or Other||Ratio of adjusted gMean|83.8|||||2-Sided|90.0|61.156|114.823|||||||
1705839|NCT00906698|3137369|Superiority or Other||Ratio of adjusted gMean|132.8|||||2-Sided|90.0|72.305|243.917|||||||
1705840|NCT00906698|3137370|Superiority or Other||Ratio of adjusted gMean|75.58|||||2-Sided|90.0|65.037|87.837|||||||
1705841|NCT00906698|3137371|Superiority or Other||Ratio of adjusted gMean|126.2|||||2-Sided|90.0|69.549|229.012|||||||
1705842|NCT00906503|3137381|Superiority or Other||Odds Ratio (OR)|1.3|Standard Deviation|1.6|||2-Sided|95.0|0.06|31.1|||||||
1705843|NCT00906399|3137385|Superiority or Other||Hazard Ratio (HR)|0.62||||0.0383|2-Sided|95.0|0.4|0.97||Based on Cox Proportional Hazards model, adjusted for baseline EDSS (< 4 versus ≥ 4) and age (< 40 versus ≥ 40 years).|Cox Proportion Hazards model||||
1705844|NCT00906399|3137385|Superiority or Other||Hazard Ratio (HR)|0.62||||0.038|2-Sided|95.0|0.4|0.97||Based on Cox Proportional Hazards model, adjusted for baseline EDSS (< 4 versus ≥ 4) and age (< 40 versus ≥ 40 years).|Cox Proportion Hazards model||||
1705845|NCT00906399|3137386|Superiority or Other||Hazard Ratio (HR)|0.61||||0.0003|2-Sided|95.0|0.47|0.8||Based on Cox proportion hazards model, adjusted for baseline EDSS (< 4 versus ≥ 4), age (<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).|Cox Proportion Hazards model||||
1705846|NCT00906399|3137386|Superiority or Other||Hazard Ratio (HR)|0.74||||0.02|2-Sided|95.0|0.57|0.95||Based on Cox proportion hazards model, adjusted for baseline EDSS (< 4 versus ≥ 4), age (<40 versus ≥ 40 years), baseline relapse rate, and baseline Gd enhancing lesions (presence versus absence).|Cox Proportion Hazards model||||
1705847|NCT00906399|3137387|Superiority or Other||Lesion Mean Ratio|0.33|||<|0.0001|2-Sided|95.0|0.27|0.4|||Negative Binomial Regression|Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.|||
1705848|NCT00906399|3137387|Superiority or Other||Lesion Mean Ratio|0.72|||<|0.0008|2-Sided|95.0|0.6|0.87|||Negative Binomial Regression|Lesion mean ratio (95% CI) and p-value based on negative binomial regression, adjusted for baseline number of T2 lesions.|||
1705849|NCT00906399|3137388|Superiority or Other||Rate Ratio|0.644||||0.0007|2-Sided|95.0|0.5|0.831|||Negative Binomial Regression|Based on negative binomial regression, with adjustment for baseline EDSS (< 4 versus ≥ 4), baseline relapse rate, age (< 40 versus ≥ 40).|||
1705850|NCT00906399|3137388|Superiority or Other||Rate Ratio|0.725||||0.0114|2-Sided|95.0|0.565|0.93|||Negative Binomial Regression|Based on negative binomial regression, with adjustment for baseline EDSS (< 4 versus ≥ 4), baseline relapse rate, age (< 40 versus ≥ 40 years).|||
1705851|NCT00906204|3137422|Superiority or Other|||||||0.85|||||||t-test, 2 sided||||
1705852|NCT00906204|3137423|Superiority or Other|||||||0.72|||||||Fisher Exact||||
1705853|NCT00906204|3137424|Superiority or Other|||||||0.78|||||||Log Rank||||
1705854|NCT00906204|3137425|Superiority or Other|||||||0.47|||||||Log Rank||||
1705855|NCT00906204|3137426|Superiority or Other|||||||0.35|||||||Log Rank||||
1705856|NCT00906204|3137427|Non-Inferiority or Equivalence|A one-sided alpha = 0.05, 85% power, an event rate of 0.70, equivalence margin of 0.20. Sample size = 75 patients per dose group, a total of 150 patients. Data analyzed will be counts of patients in each group who experience one or more component events of the primary endpoint during postoperative days one through seven. The DSMB requested an interim analysis after 80 patients and recommended ending the trial because the primary endpoint had been robustly reached.||||||0.64|||||||Fisher Exact|||The analysis compares the rates at which patients in each of the two groups cumulatively exceed the five composite endpoint thresholds. There are five safety outcomes monitored during the first seven post-transplantation days. The rates of observed vs. possible safety outcomes are compared.|
1705857|NCT00906178|3137428|Superiority or Other||Odds Ratio (OR)|0.7|||||2-Sided|95.0|0.37|1.3|||||||
1705858|NCT00906178|3137429|Superiority or Other||Odds Ratio (OR)|1.56|||||2-Sided|95.0|0.93|2.62|||||||
1705859|NCT00906178|3137430|Superiority or Other||Odds Ratio (OR)|1.01|||||2-Sided|95.0|0.62|1.65|||||||
1705860|NCT00906178|3137431|Superiority or Other||Odds Ratio (OR)|1.05|||||2-Sided|95.0|0.57|1.94|||||||
1705861|NCT00906074|3137447|Superiority or Other|||||||0.444|||||||Fisher Exact||||
1705862|NCT00906074|3137448|Superiority or Other|||||||0.156|||||||Chi-squared|Chi-squared Pearson|||
1705863|NCT00906074|3137453|Superiority or Other|||||||0.873|||||||Chi-squared|Chi-squared Pearson|||
1705864|NCT00906074|3137454|Superiority or Other|||||||1|||||||Chi-squared|Chi-squared Pearson|||
1705870|NCT00906074|3137455|Superiority or Other|||||||0.517|||||||Chi-squared|Chi-squared Pearson||Tobacco use|
1705871|NCT00906074|3137455|Superiority or Other|||||||0.881|||||||Chi-squared|Chi-squared Pearson||Neoplasm|
1705872|NCT00905840|3137459|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|36 month data Sulcus Bleeding Index|||
1705873|NCT00905840|3137459|Superiority or Other|||||||0.3667|||||||Wilcoxon (Mann-Whitney)|24 month data Sulcus Bleeding Index|||
1705874|NCT00905840|3137459|Superiority or Other|||||||0.9933|||||||Wilcoxon (Mann-Whitney)|12 month data Sulcus Bleeding Index|||
1705875|NCT00905840|3137459|Superiority or Other|||||||0.4312|||||||Wilcoxon (Mann-Whitney)|36 month data Plaque Index|||
1705876|NCT00905840|3137459|Superiority or Other|||||||0.7068|||||||Wilcoxon (Mann-Whitney)|24 month data Plaque index|||
1705877|NCT00905840|3137459|Superiority or Other|||||||0.3617||||||12 month data Plaque index|Wilcoxon (Mann-Whitney)||||
1705878|NCT00905840|3137460|Superiority or Other|||||||0.1573|||||||McNemar|||This analysis is up to 12 month.|
1705879|NCT00905840|3137461|Non-Inferiority or Equivalence|The analysis of the primary outcome variable, was based on a confirmatory non-inferiority test with a one-sided 97.5% confidence interval. The non-inferiority margin for a clinically relevant difference was set at 0.1 mm. For a sample size of st least 73, a paired t-test with a 0.0025 one-sided significant level was calculated to have 80% power to reject the hypothesis that the test is inferior to the standard.|Mean Difference (Final Values)|0.1||||0.025|2-Sided|97.5|0.1|0.3|||Student's t-test|||"Null hypothesis: Change of functional bone level at the test implant 12 month after surgery is more than 0.1 lower (inferior) than change of functional crestal bone level at the control implant 12 month after surgery.~H-1: Change of functional bone level at the tst implant 12 month after surgery is up to 0.1 lower, equal, or higher (not inferior) than change of functional crestal bone level at the control implant 12 month after surgery."|
1705880|NCT00905827|3137463|Superiority or Other|||||||0.01|||||||ANOVA|||Pairwise comparisons (ANOVA simple effect comparisons) adjusted for baseline scores|
1705881|NCT00905827|3137463|Superiority or Other||||||<|0.01|||||||ANOVA|||Pairwise comparisons (ANOVA simple effect comparisons) adjusted for baseline scores|
1705882|NCT00905606|3137485|Non-Inferiority or Equivalence|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|98.19||||||90.0|94.64|101.87|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705883|NCT00905606|3137486|Non-Inferiority or Equivalence|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|98.27||||||90.0|94.63|102.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705884|NCT00905606|3137487|Non-Inferiority or Equivalence|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA guidelines.|Ratio of the LS Mean (test/ref x 100)|93.91||||||90.0|85.42|103.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705885|NCT00905567|3137492|Non-Inferiority or Equivalence|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|96.43||||||90.0|||||||Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.||
1705886|NCT00905567|3137493|Non-Inferiority or Equivalence|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|96.62||||||90.0|||||||Bioequivalence is established when the Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.||
1705887|NCT00905567|3137494|Non-Inferiority or Equivalence|ANOVA was performed on ln-transformed AUC0-t, AUC0-72h, and Cmax. All analyses were performed according to FDA's guidleines.|Ratio of the Least Squares Mean|93.01||||||90.0|||||||Bioequivalence is established when Ratio of the Least Squares Mean (test/reference x 100) falls within 80-125.||
1705888|NCT00905489|3137515|Superiority or Other||Ratio NVP XR: NVP IR (%)|91.2|Standard Error of the Mean|1.05||0.008|2-Sided|90.0|83.47|99.64|||Mixed Models Analysis|Adjusted geometric means are estimated from the mixed model for intra-individual comparison.|||
1705889|NCT00905424|3137523|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.0852|2-Sided|90.0|-2.8|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA||||
1705890|NCT00905424|3137524|Superiority or Other||Mean Difference (Final Values)|-3.7||||0.1489|2-Sided|90.0|-8.0|0.5||The test was performed a priori at the significance level of 0.10|ANCOVA||||
1705891|NCT00905424|3137525|Superiority or Other||Mean Difference (Final Values)|2.3||||0.2079|2-Sided|90.0|-0.7|5.2||The test was performed a priori at the significance level of 0.10|ANCOVA|||Metacognition Index|
1705892|NCT00905424|3137525|Superiority or Other||Mean Difference (Final Values)|1.1||||0.559|2-Sided|90.0|-2.1|4.4||The test was performed a priori at the significance level of 0.10|ANCOVA|||Behavioral Regulation Index|
1705893|NCT00905424|3137525|Superiority or Other||Mean Difference (Final Values)|1.8||||0.2876|2-Sided|90.0|-1.0|4.7||The test was performed a priori at the significance level of 0.10|ANCOVA|||Global Executive Composite|
1705894|NCT00905424|3137528|Superiority or Other|||||||0.523|||||||Cochran-Mantel-Haenszel||||
1705895|NCT00905424|3137529|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.463|2-Sided|90.0|-3.1|1.2||The test was performed a priori at the significance level of 0.10|ANCOVA||||
1705896|NCT00905424|3137530|Superiority or Other||Mean Difference (Final Values)|0.9||||0.5182|2-Sided|90.0|-1.4|3.1||The test was performed a priori at the significance level of 0.10|ANCOVA||||
1705897|NCT00905424|3137531|Superiority or Other||Mean Difference (Final Values)|1.2||||0.4726|2-Sided|90.0|-1.6|4.0||The test was performed a priori at the significance level of 0.10|ANCOVA||||
1705898|NCT00905424|3137532|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.0774|2-Sided|90.0|-2.2|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA||||
1705899|NCT00905424|3137533|Superiority or Other||Mean Difference (Final Values)|-3.0||||0.092|2-Sided|90.0|-6.0|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA||||
1706032|NCT00904033|3137738|Other|||||||0.86|||||||ANCOVA|Main Effects Results only for No Exercise vs Exercise|||
1705900|NCT00905424|3137534|Superiority or Other||Mean Difference (Final Values)|-3.3||||0.0281|2-Sided|90.0|-5.8|-0.8||The test was performed a priori at the significance level of 0.10|ANCOVA|||Metacognition Index|
1705901|NCT00905424|3137534|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.1431|2-Sided|90.0|-4.3|0.3||The test was performed a priori at the significance level of 0.10|ANCOVA|||Behavioral Regulation Index|
1705902|NCT00905424|3137534|Superiority or Other||Mean Difference (Final Values)|-3.0||||0.0463|2-Sided|90.0|-5.4|-0.5||The test was performed a priori at the significance level of 0.10|ANCOVA|||Global Executive Composite|
1705903|NCT00905424|3137537|Superiority or Other|||||||0.2368|||||||Cochran-Mantel-Haenszel||||
1705904|NCT00905424|3137538|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.0573|2-Sided|90.0|-3.7|-0.3||The test was performed a priori at the significance level of 0.10|ANCOVA||||
1705905|NCT00905424|3137539|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.3091|2-Sided|90.0|-2.4|0.6||The test was performed a priori at the significance level of 0.10|ANCOVA||||
1705906|NCT00905424|3137540|Superiority or Other||Mean Difference (Final Values)|-2.3||||0.0902|2-Sided|90.0|-4.5|-0.1||The test was performed a priori at the significance level of 0.10|ANCOVA||||
1705907|NCT00905359|3137555|Non-Inferiority or Equivalence|t-test analysis performed using Multiple imputation and one-sided p-value testing non-inferiority of the percentage change from baseline at 10%. One-sided p-value is significant if <0.025 or the upper limit of the CI is less than 10%.||||||0.172|||||||t-test, 1 sided||||
1705908|NCT00905346|3137556|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|102.63||||||90.0|99.24|106.14|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705909|NCT00905346|3137557|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|102.92||||||90.0|99.88|106.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705910|NCT00905346|3137558|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (Test/Ref x 100)|98.39||||||90.0|94.36|102.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705911|NCT00905307|3137559|Superiority or Other||Relative Risk|0.63||||0.2133||95.0|0.3|1.34||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705912|NCT00905307|3137559|Superiority or Other||Relative Risk|0.61||||0.0946|2-Sided|95.0|0.33|1.1||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705913|NCT00905307|3137559|Superiority or Other||Relative Risk|0.67||||0.1854|2-Sided|95.0|0.36|1.23||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705914|NCT00905307|3137559|Superiority or Other||Relative Risk|0.82||||0.4492|2-Sided|95.0|0.49|1.38||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705915|NCT00905307|3137559|Superiority or Other||Relative risk|1.06||||0.854|2-Sided|95.0|0.59|1.88||Derived using CMH test stratified by trial center.|Cochran-Mantel-Haenszel|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705916|NCT00905307|3137560|Superiority or Other||Relative Risk|1.15||||0.3892|2-Sided|95.0|0.85|1.56|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705917|NCT00905307|3137560|Superiority or Other||Relative Risk|1.02||||0.867|2-Sided|95.0|0.78|1.34|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705918|NCT00905307|3137560|Superiority or Other||Relative Risk|0.91||||0.5271|2-Sided|95.0|0.66|1.25|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705971|NCT00904748|3137673|Non-Inferiority or Equivalence|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|97.84|||||2-Sided|90.0|91.56|104.56|||||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).|
1705919|NCT00905307|3137560|Superiority or Other||Relative Risk|1.19||||0.1501|2-Sided|95.0|0.95|1.48|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705920|NCT00905307|3137560|Superiority or Other||Relative Risk|0.89||||0.62|2-Sided|95.0|0.57|1.4|||Cochran-Mantel-Haenszel|CMH general association test controlling for study center will be applied to the analysis of response rate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705921|NCT00905307|3137561|Superiority or Other|||||||0.1149|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705922|NCT00905307|3137561|Superiority or Other|||||||0.1045|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705923|NCT00905307|3137561|Superiority or Other|||||||0.2739|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705924|NCT00905307|3137561|Superiority or Other|||||||0.1117|||||||Cochran-Mantel-Haenszel|The CMH row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705925|NCT00905307|3137561|Superiority or Other|||||||0.4008|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel (CMH) row mean scores differ test controlling for study center was applied to mean CGI-I score||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705926|NCT00905307|3137562|Superiority or Other||Treatment difference|-0.21||||0.2851|2-Sided|95.0|-0.59|0.18|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705927|NCT00905307|3137562|Superiority or Other||Treatment difference|-0.28||||0.0898|2-Sided|95.0|-0.6|0.04|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705928|NCT00905307|3137562|Superiority or Other||Treatment difference|-0.04||||0.8006|2-Sided|95.0|-0.37|0.28|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705929|NCT00905307|3137562|Superiority or Other||Treatment difference|-0.28||||0.0989|2-Sided|95.0|-0.6|0.05|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705930|NCT00905307|3137562|Superiority or Other||Treatment difference|0.38||||0.0685|2-Sided|95.0|-0.03|0.79|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in CGI-S score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705931|NCT00905307|3137563|Superiority or Other||Treatment difference|3.25||||0.1819|2-Sided|95.0|-1.53|8.03|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705932|NCT00905307|3137563|Superiority or Other||Treatment difference|3.86||||0.0596|2-Sided|95.0|-0.16|7.89|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1709133|NCT00852995|3144526|Superiority or Other|||||||0.024||||||Week 11|Cochran-Mantel-Haenszel||||
1705933|NCT00905307|3137563|Superiority or Other||Treatment difference|2.2||||0.2944|2-Sided|95.0|-1.92|6.32|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705934|NCT00905307|3137563|Superiority or Other||Treatment difference|3.8||||0.0664|2-Sided|95.0|-0.26|7.85|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PSP score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705935|NCT00905307|3137563|Superiority or Other||Treatment difference|-2.36||||0.3726|2-Sided|95.0|-7.57|2.85|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PSP score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705936|NCT00905307|3137564|Superiority or Other||Treatment difference|-0.15||||0.8611|2-Sided|95.0|-1.9|1.59|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705937|NCT00905307|3137564|Superiority or Other||Treatment difference|-0.73||||0.2777|2-Sided|95.0|-2.05|0.59|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705938|NCT00905307|3137564|Superiority or Other||Treatment difference|-0.35||||0.6074|2-Sided|95.0|-1.69|0.99|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705939|NCT00905307|3137564|Superiority or Other||Treatment difference|-0.61||||0.3701|2-Sided|95.0|-1.94|0.72|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705940|NCT00905307|3137564|Superiority or Other||Treatment difference|1.0||||0.2896|2-Sided|95.0|-0.86|2.86|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS negative subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705941|NCT00905307|3137565|Superiority or Other||Treatment difference|-1.79||||0.1111|2-Sided|95.0|-4.0|0.42|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705942|NCT00905307|3137565|Superiority or Other||Treatment difference|-1.24||||0.1764|2-Sided|95.0|-3.05|0.56|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705943|NCT00905307|3137565|Superiority or Other||Treatment difference|-0.13||||0.8879|2-Sided|95.0|-1.96|1.69|||ANCOVA|||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of -11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705944|NCT00905307|3137565|Superiority or Other||Treatment difference|-1.41||||0.1313|2-Sided|95.0|-3.24|0.42|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of −11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705945|NCT00905307|3137565|Superiority or Other||Treatment difference|1.61||||0.1807|2-Sided|95.0|-0.75|3.97|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of −11.5 points in the mean change from baseline in PANSS positive subscale score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705946|NCT00905307|3137566|Superiority or Other||Treatment difference|-3.64||||0.3074|2-Sided|95.0|-10.7|3.38|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate|||
1705972|NCT00904748|3137673|Non-Inferiority or Equivalence|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|99.12|||||2-Sided|90.0|92.76|105.93|||||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).|
1705947|NCT00905307|3137566|Superiority or Other||Treatment difference|4.62||||0.2263|2-Sided|95.0|-2.89|12.12|||ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of −11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705948|NCT00905307|3137566|Superiority or Other||Treatment difference|-3.86||||0.3293|2-Sided|95.0|-9.32|1.59||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of −11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705949|NCT00905307|3137566|Superiority or Other||Treatment difference|-1.44||||0.6066|2-Sided|95.0|-6.96|4.07||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of −11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test|
1705950|NCT00905307|3137566|Superiority or Other||Treatment difference|-4.7||||0.2846|2-Sided|95.0|-10.2|0.82||The Hochberg procedure using two-sided alpha of 0.05 was applied to control the type I error rate at 0.05 level (two-sided) due to multiple comparisons.|ANCOVA|With treatment and trial center as main effects, and baseline value as covariate||Sample size was determined to achieve at least 80% power at alpha level of 0.0167 (two-sided) to detect a difference of −11.5 points in the mean change from baseline in PANSS Total Score at week 6 (LOCF) between an individual OPC-34712 treatment group (except the 0.25 mg QD fixed dose group) and placebo using a two-sided z-test.|
1705951|NCT00905164|3137583|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|101.53||||||90.0|99.01|104.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705952|NCT00905164|3137584|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS mean (test/ref x 100)|100.13||||||90.0|97.6|102.72|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1705953|NCT00905164|3137585|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS mean (test/ref x 100)|99.5||||||90.0|94.27|105.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125||
1705954|NCT00904943|3137638|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|103.66||||||90.0|||||||Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.||
1705955|NCT00904943|3137639|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|102.35||||||90.0|||||||Bioequivalence is established when Ratio of the Least Squares Mean falls within 80-125.||
1705956|NCT00904943|3137640|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of the LS Mean (test/ref x 100)|104.27||||||90.0|||||||Bioequivalence is established when Ratio of the Mean falls within 80-125.||
1705957|NCT00904917|3137642|Superiority or Other|||||||0.037|||||||Regression, Linear||||
1705958|NCT00904917|3137644|Superiority or Other|||||||0.015|||||||t-test, 2 sided||||
1705959|NCT00904839|3137655|Superiority or Other||Difference|-5.0|||||2-Sided|95.0|-15.3|5.2|||||confidence interval includes 0, meaning that the null hypothesis (no difference between the 2 groups) cannot be rejected (i.e. pvalue > 0.05). The pvalue was not computed. Difference in Kaplan-Meier Resection Rates using Peto´s variance estimate.||
1705960|NCT00904839|3137660|Superiority or Other||Difference|-8.1|||||2-Sided|95.0|-27.8|11.5|||||Difference in Kaplan-Meier Progression-free Survival Rates at 9 Months using Peto´s variance estimate.||
1705961|NCT00904826|3137661|Superiority or Other|||||||0.0019|||||||Wilcoxon (Mann-Whitney)|||Comparison was between 3 months and baseline.|
1705962|NCT00904826|3137663|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Comparison is between 12 months and baseline.|
1705963|NCT00904826|3137663|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Comparison is between 9 months and baseline.|
1705964|NCT00904826|3137663|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Comparison is between 6 months and baseline|
1705965|NCT00904826|3137663|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Comparison is between 3 months and baseline.|
1705966|NCT00904826|3137663|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Comparison is between 6 weeks and baseline.|
1705967|NCT00904826|3137667|Superiority or Other|||||||0.0078|||||||Wilcoxon (Mann-Whitney)|||Comparison was made between baseline and after 12 months of treatment.|
1705968|NCT00904826|3137669|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Comparison between before treatment and one year after treatment.|
1705969|NCT00904748|3137672|Superiority or Other||Mean Difference (Final Values)|0.01|||||2-Sided|90.0|-0.27|0.28||||||Difference in Tmax between Test 2 study treatment (chewable with water) and reference study treatment (coated with water).|
1705970|NCT00904748|3137672|Superiority or Other||Mean Difference (Final Values)|0.18|||||2-Sided|90.0|-0.14|0.5||||||Difference in Tmax between Test 1 study treatment (chewable without water) and reference study treatment (coated with water).|
1706024|NCT00904150|3137730|Superiority or Other|||||||0.513|||||||Chi-squared|||Statistical analysis is of the distribution of PR PROGINS polymorphism frequencies between groups|
1705973|NCT00904748|3137674|Non-Inferiority or Equivalence|Percent of reference to detect for 2-1 tests and power = 20%.|ratio between geometric means|78.76|||||2-Sided|90.0|70.53|87.96|||||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).|
1705974|NCT00904748|3137674|Non-Inferiority or Equivalence|Percent of reference to detect for 2-1 tests and power = 20%.|ratio between geometric means|80.83|||||2-Sided|90.0|72.38|90.26|||||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).|
1705975|NCT00904748|3137675|Non-Inferiority or Equivalence|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|97.23|||||2-Sided|90.0|90.67|104.26|||||Estimated value = ratio (% reference).|Ratio between geometric means of Test 2 study treatment (chewable with water) and reference study treatment (coated with water).|
1705976|NCT00904748|3137675|Non-Inferiority or Equivalence|Percent of reference to detect for 2-1 tests and power = 20.0%.|ratio between geometric means|98.68|||||2-Sided|90.0|92.03|105.82|||||Estimated value = ratio (% reference).|Ratio between geometric means of Test 1 study treatment (chewable without water) and reference study treatment (coated with water).|
1705977|NCT00904670|3137678|Superiority or Other||LS mean difference|-1.12|Standard Error of the Mean|0.4||0.0087|2-Sided|95.0|-1.94|-0.3|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705978|NCT00904670|3137678|Superiority or Other||LS mean difference|-1.57|Standard Error of the Mean|0.41||0.0006|2-Sided|95.0|-2.4|-0.73|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705979|NCT00904670|3137678|Superiority or Other||LS mean difference|-2.7|Standard Error of the Mean|0.46|<|0.0001|2-Sided|95.0|-3.64|-1.76|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705980|NCT00904670|3137678|Superiority or Other||LS mean difference|-3.34|Standard Error of the Mean|0.38|<|0.0001|2-Sided|95.0|-4.11|-2.57|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705981|NCT00904670|3137678|Superiority or Other||LS mean difference|-2.94|Standard Error of the Mean|0.41|<|0.0001|2-Sided|95.0|-3.78|-2.1|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705982|NCT00904670|3137678|Superiority or Other||LS mean difference|-1.72|Standard Error of the Mean|0.35|<|0.0001|2-Sided|95.0|-2.43|-1.0|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705983|NCT00904670|3137679|Superiority or Other||LS mean difference|-1.34|Standard Error of the Mean|0.5||0.0105|2-Sided|95.0|-2.34|-0.33|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705984|NCT00904670|3137679|Superiority or Other||LS mean difference|-0.43|Standard Error of the Mean|0.45||0.3492|2-Sided|95.0|-1.34|0.49|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705985|NCT00904670|3137679|Superiority or Other||LS mean difference|-2.65|Standard Error of the Mean|0.65||0.0002|2-Sided|95.0|-3.97|-1.33|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705986|NCT00904670|3137679|Superiority or Other||LS mean difference|-3.89|Standard Error of the Mean|0.6|<|0.0001|2-Sided|95.0|-5.12|-2.67|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705987|NCT00904670|3137679|Superiority or Other||LS mean difference|-2.79|Standard Error of the Mean|0.48|<|0.0001|2-Sided|95.0|-3.76|-1.82|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706025|NCT00904033|3137731|Other|||||||0.92|||||||t-test, 2 sided||||
1706026|NCT00904033|3137732|Other|||||||0.38|||||||t-test, 2 sided||||
1706027|NCT00904033|3137733|Other|||||||0.84|||||||t-test, 2 sided||||
1705988|NCT00904670|3137679|Superiority or Other||LS mean difference|-1.8|Standard Error of the Mean|0.52|<|0.0014|2-Sided|95.0|-2.85|-0.74|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705989|NCT00904670|3137681|Superiority or Other||LS mean difference|20.69|Standard Error of the Mean|6.18||0.0019|2-Sided|95.0|8.17|33.22|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705990|NCT00904670|3137681|Superiority or Other||LS mean difference|14.86|Standard Error of the Mean|5.86||0.0155|2-Sided|95.0|3.0|26.73|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705991|NCT00904670|3137681|Superiority or Other||LS mean difference|35.46|Standard Error of the Mean|6.57|<|0.0001|2-Sided|95.0|22.14|48.78|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705992|NCT00904670|3137681|Superiority or Other||LS mean difference|45.77|Standard Error of the Mean|7.35|<|0.0001|2-Sided|95.0|30.89|60.65|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705993|NCT00904670|3137681|Superiority or Other||LS mean difference|37.1|Standard Error of the Mean|5.21|<|0.0001|2-Sided|95.0|26.54|47.66|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705994|NCT00904670|3137681|Superiority or Other||LS mean difference|25.61|Standard Error of the Mean|4.61|<|0.0001|2-Sided|95.0|16.26|34.96|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705995|NCT00904670|3137682|Superiority or Other||LS mean difference|-1.43|Standard Error of the Mean|0.53||0.0109|2-Sided|95.0|-2.51|-0.35|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705996|NCT00904670|3137682|Superiority or Other||LS mean difference|-1.26|Standard Error of the Mean|0.4||0.0035|2-Sided|95.0|-2.07|-0.44|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705997|NCT00904670|3137682|Superiority or Other||LS mean difference|-2.49|Standard Error of the Mean|0.41|<|0.0001|2-Sided|95.0|-3.33|-1.66|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705998|NCT00904670|3137682|Superiority or Other||LS mean difference|-2.95|Standard Error of the Mean|0.4|<|0.0001|2-Sided|95.0|-3.77|-2.13|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1705999|NCT00904670|3137682|Superiority or Other||LS mean difference|-2.66|Standard Error of the Mean|0.41|<|0.0001|2-Sided|95.0|-3.5|-1.82|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706000|NCT00904670|3137682|Superiority or Other||LS mean difference|-1.69|Standard Error of the Mean|0.33|<|0.0001|2-Sided|95.0|-2.36|-1.02|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706001|NCT00904670|3137683|Superiority or Other||LS mean difference|-0.88|Standard Error of the Mean|0.43||0.0491|2-Sided|95.0|-1.76|0.0|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706028|NCT00904033|3137734|Other|||||||0.16|||||||t-test, 2 sided||||
1706029|NCT00904033|3137735|Other||||||<|0.01|||||||ANCOVA||||
1706002|NCT00904670|3137683|Superiority or Other||LS mean difference|-0.54|Standard Error of the Mean|0.41||0.1977|2-Sided|95.0|-1.38|0.29|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706003|NCT00904670|3137683|Superiority or Other||LS mean difference|-1.49|Standard Error of the Mean|0.51||0.0055|2-Sided|95.0|-2.52|-0.47|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706004|NCT00904670|3137683|Superiority or Other||LS mean difference|-2.28|Standard Error of the Mean|0.54||0.0001|2-Sided|95.0|-3.37|-1.2|||ANOVA|||Hour 4: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706005|NCT00904670|3137683|Superiority or Other||LS mean difference|-1.59|Standard Error of the Mean|0.31|<|0.0001|2-Sided|95.0|-2.23|-0.95|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706006|NCT00904670|3137683|Superiority or Other||LS mean difference|-1.12|Standard Error of the Mean|0.38|<|0.0051|2-Sided|95.0|-1.88|-0.36|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706007|NCT00904670|3137684|Superiority or Other||LS mean difference|-4.77|Standard Error of the Mean|1.4||0.0016|2-Sided|95.0|-7.61|-1.94|||ANOVA|||Hour 12: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706008|NCT00904670|3137684|Superiority or Other||LS mean difference|-3.79|Standard Error of the Mean|1.11||0.0016|2-Sided|95.0|-6.04|-1.54|||ANOVA|||Hour 10: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706009|NCT00904670|3137684|Superiority or Other||LS mean difference|-9.33|Standard Error of the Mean|1.28|<|0.0001|2-Sided|95.0|-11.92|-6.75|||ANOVA|||Hour 8: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706010|NCT00904670|3137684|Superiority or Other||LS mean difference|-9.98|Standard Error of the Mean|1.02|<|0.0001|2-Sided|95.0|-12.04|-7.91|||ANOVA|||Hour 2: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706011|NCT00904670|3137684|Superiority or Other||LS mean difference|-6.32|Standard Error of the Mean|1.09|<|0.0001|2-Sided|95.0|-8.53|-4.11|||ANOVA|||Hour 0.75: Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706012|NCT00904670|3137685|Superiority or Other||Least Square (LS) mean difference|-12.46|Standard Error of the Mean|1.13|<|0.0001|2-Sided|95.0|-14.75|-10.17|||ANOVA|||Treatment comparisons for observed scores were assessed using linear models with sequence (Placebo/NWP06 and NWP06/Placebo), period, and treatment (NWP06 and Placebo) as fixed effects, and participant within sequence as a repeated effect with a compound symmetry correlation structure. A negative point difference indicated a positive effect of NWP06 over Placebo.|
1706013|NCT00904618|3137687|Superiority or Other|||||||0.0087|||||||Fisher Exact|||The test applies to the number of participants improved.|
1706014|NCT00904215|3137718|Superiority or Other||||||<|0.0001|||||||Student Paired t-test||||
1706015|NCT00904215|3137719|Superiority or Other||||||<|0.0001|||||||Student Paired t-test||||
1706016|NCT00904215|3137720|Superiority or Other||||||<|0.0001|||||||Student Paired t-test||||
1706017|NCT00904215|3137721|Superiority or Other||||||<|0.0001|||||||Student Paired t-test||||
1706018|NCT00904150|3137724|Superiority or Other||||||>|0.05|||||||t-test, 1 sided||||
1706019|NCT00904150|3137725|Superiority or Other||||||>|0.05|||||||t-test, 1 sided||||
1706020|NCT00904150|3137726|Superiority or Other|||||||0.18|||||||Chi-squared|||Statistical analysis is of the distribution of Estrogen receptor 1 C325G polymorphism frequencies between groups|
1706021|NCT00904150|3137727|Superiority or Other||Odds Ratio (OR)|0.69||||0.02462||95.0|0.49|0.95|||Chi-squared|||Analysis of distribution of SYNE1 genotype frequencies between groups|
1706022|NCT00904150|3137728|Superiority or Other||Odds Ratio (OR)|0.434||||0.002743||95.0|0.24|0.75|||Chi-squared|||Analysis of distribution of TNF genotype frequencies between groups|
1706023|NCT00904150|3137729|Superiority or Other|||||||0.75|||||||Chi-squared|||Statistical analysis is of the distribution of Estrogen receptor 1 G594a polymorphism frequencies between groups|
1706030|NCT00904033|3137736|Other|||||||0.49|||||||ANCOVA||||
1706033|NCT00903695|3137773|Superiority or Other|||||||0.34||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.06, t-test = -1.03"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).|
1706034|NCT00903695|3137774|Superiority or Other|||||||0.18||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 2.25, ttest = -1.5"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).|
1706035|NCT00903695|3137775|Superiority or Other|||||||0.71||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 0.15, t-test = 0.39"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).|
1706036|NCT00903695|3137776|Superiority or Other|||||||0.24||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.7, t-test = 1.3"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).|
1706037|NCT00903695|3137777|Superiority or Other|||||||0.27||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA: F-ratio = 1.5, t-test = -1.23"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).|
1706038|NCT00903695|3137778|Superiority or Other|||||||0.31||||||a priori threshold for statistical sginficance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA calculation: F-ratio=1.22, t-test=1.1"||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).|
1706039|NCT00903695|3137779|Superiority or Other|||||||0.8133||||||a priori threshold for statistical significance = 0.01 (multiple comparisons)|ANOVA|"DF = 6~ANOVA calculation: F-ratio = 0.06, t-test = -0.25."||ANOVA used to detect significant difference in test scores between baseline and end assessments, by study arm (nutriceutical vs placebo).|
1706040|NCT00903682|3137786|Superiority or Other||Difference in proportion of response|1.61|||||2-Sided|95.0|-12.0|15.23|||||Difference in proportion of response ETR minus EFV||
1706041|NCT00903682|3137787|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||The hypothesis is that the proportion of patients with at least 1 treatment-emergent Grade 1-4 neuropsychiatric adverse event, observed between Baseline through Week 12 and judged to be at least possibly drug-related, is significantly lower in the ETR arm than in the EFV arm. Assuming a significance level of 5%, a sample size of 75 subjects per arm would provide over 90% power to detect a 29% difference in treatment-emergent, drug-related Grade 1-4 neuropsychiatric adverse events.|
1706042|NCT00903448|3137816|Superiority or Other||Mean Difference (Final Values)|8.9|Standard Error of the Mean|2.1|<|0.0001|2-Sided|95.0||||The least squares treatment means, i.e. adjusted treatment means, and standard errors were computed from the analysis of variance models.|Mixed Models Analysis|||This study enrolled 40 subjects in order to complete a target of at least 30 evaluable subjects. For the purpose of determination of sample size, it was assumed that at least 30 subjects would have complete data for all 3 treatment periods. Assuming the true mean difference in % time that gastric pH > 4.0 between Prilosec OTC and Prevacid was at least 6.5, it was estimated that there would be at least 80% power to detect a treatment difference in 2-sided testing at the 5% significance level.|
1706043|NCT00903409|3137819|Superiority or Other||||||<|0.001||||||The difference between Non-switchers and Switchers in the percent change in non-HDL-C level from the end of the OM6 double-blind study (average of Weeks 6 and 8 for the statistical analysis) to 4 months of OM6X open-label treatment (Month 4).|Kruskal-Wallis||||
1706044|NCT00903331|3137842|Superiority or Other||Hazard Ratio (HR)|1.118||||0.7056|2-Sided|95.0|0.626|1.996|||Log Rank||||
1706045|NCT00903331|3137843|Superiority or Other||Median Difference (Net)|0.0||||0.9631|2-Sided|95.0|-0.09|0.08|||Wilcoxon Rank Sum|||The null hypothesis was that there was no difference between ACT-064922 and placebo for the change in FVC from baseline to the end of Period 1. The aim was to detect a placebo-corrected change in FVC of ≥ 0.1 L (Standard Deviation = 0.2 L) at a two-sided 0.05 type 1 error level and 80% power.|
1706046|NCT00903175|3137874|Non-Inferiority or Equivalence|Primary objective was to assess the non-inferiority of everolimus as compared to Sunitinib in terms of PFS-1L & was based on Bayesian methodology. If the estimated HR for PFS-1L had a value ≤ 1.1, non-inferiority of everolimus to Sunitinib would be declared. Non-inferiority of everolimus compared with Sunitinib as a first-line therapy was not achieved. The estimated HR for PFS-1L was 1.43 which did not satisfy the protocol-defined non-inferiority margin of a HR ≤ 1.1.|Hazard Ratio (HR)|1.43|||||2-Sided|95.0|1.15|1.77|||||||
1706047|NCT00903032|3137878|Non-Inferiority or Equivalence|Previously provided||||||0.003|||||||Chi-squared|||Unpaired t tests were used to compare continuous variables, and χ2 testswere used to compare categorical variables across the intervention and usual care. We used a log-rank test to compare the hazardof first hospitalization for MI, revascularization, or death.We used a Wilcoxon rank sum test to compare PDCs between study arms. For all other outcomes, χ2 tests and t testswere used for comparisons, as appropriate.|
1706048|NCT00902577|3137894|Other|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.72|||||2-Sided|95.0|0.55|0.89||||||nCBF provides a measure of vascular permeability and perfusion. Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.|
1706049|NCT00902577|3137894|Other|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.72|||||2-Sided|95.0|0.54|0.89||||||nRCBV provides a measure of tumor vasculature Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9.|
1706050|NCT00902577|3137894|Other|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.64|||||2-Sided|95.0|0.44|0.84||||||"Median ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of Median ktrans to predict PFS9."|
1706182|NCT00896363|3138343|Superiority or Other||Mean Difference (Net)|0.31|||||2-Sided|90.0|-0.93|1.56|||||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 1 mg on Day 14|
1706051|NCT00902577|3137894|Other|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.62|||||2-Sided|95.0|0.42|0.83||||||"mean ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of mean ktrans to predict PFS9."|
1706052|NCT00902577|3137894|Other|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.64|||||2-Sided|95.0|0.46|0.83||||||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."|
1706053|NCT00902577|3137894|Other|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.59|||||2-Sided|95.0|0.39|0.78||||||"T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."|
1706054|NCT00902577|3137894|Other|An Area Under the Curve (AUC) with a lower bound of at least 0.5 is considered statistically significant.|Area Under the Curve (AUC)|0.61|||||2-Sided|95.0|0.42|0.79||||||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.~Receiver Operating Characteristic(ROC) analysis was perform to determine the accuracy of this marker to predict PFS9."|
1706055|NCT00902577|3137894|Other||Odds Ratio (OR)|0.884||||0.1921|2-Sided|95.0|0.735|1.064|||Regression, Logistic|||Apparent Diffusion Coefficient (ADC) high values were modeled with a univariate Logistic regression model for PFS6|
1706056|NCT00902577|3137894|Other||Odds Ratio (OR)|0.855||||0.5069|2-Sided|95.0|0.539|1.357|||Regression, Logistic|||Apparent Diffusion Coefficient (ADC) low values were modeled with a univariate logistic regression model for PFS6|
1706057|NCT00902577|3137894|Other||Odds Ratio (OR)|0.821||||0.2642|2-Sided|95.0|0.58|1.161|||Regression, Logistic|||"cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF.~nCBF was modeled with a univariate logistic regression model for PFS6."|
1706058|NCT00902577|3137894|Other||Odds Ratio (OR)|0.744||||0.134|2-Sided|95.0|0.506|1.095|||Regression, Logistic|||"Relative cerebral blood volume (RCBV) maps were corrected for leakage effects and normalized to normal appearing white matter (nRCBV).~nRCBV was modeled with a univariate logistic regression model for PFS6."|
1706059|NCT00902577|3137894|Other||Odds Ratio (OR)|0.919||||0.6941|2-Sided|95.0|0.602|1.402|||Regression, Logistic|||"Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate logistic regression model for PFS6"|
1706060|NCT00902577|3137894|Other||Odds Ratio (OR)|0.993||||0.9554|2-Sided|95.0|0.775|1.273|||Regression, Logistic|||"Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Mean ktrans was modeled with a univariate logistic regression model for PFS6."|
1706061|NCT00902577|3137894|Other||Odds Ratio (OR)|0.957||||0.1566|2-Sided|95.0|0.9|1.017|||Regression, Logistic|||Hypoxic Volume (HV) was modeled with a logistic regression model for 6month progression free survival (PFS6) .|
1706062|NCT00902577|3137894|Other||Odds Ratio (OR)|0.991||||0.9836|2-Sided|95.0|0.403|2.434|||Regression, Logistic|||TBmax was modeled with a univariate logistic regression model for PFS6.|
1706063|NCT00902577|3137894|Other||Odds Ratio (OR)|0.682||||0.3253|2-Sided|95.0|0.318|1.463|||Regression, Logistic|||Logistic regression for SUVpeak to predict PFS6|
1706064|NCT00902577|3137894|Other||Hazard Ratio (HR)|1.18||||0.038|2-Sided|95.0|1.01|1.38|||Regression, Cox|||"cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion.~nCBF was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."|
1706065|NCT00902577|3137894|Other||Hazard Ratio (HR)|1.28||||0.0096|2-Sided|95.0|1.06|1.54|||Regression, Cox|||"Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for PFS time.~The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."|
1706066|NCT00902577|3137894|Other||Hazard Ratio (HR)|1.3||||0.021|2-Sided|95.0|1.04|1.63|||Regression, Cox|||"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."|
1706067|NCT00902577|3137894|Other||Hazard Ratio (HR)|1.1||||0.074|2-Sided|95.0|0.99|1.23|||Regression, Cox|||"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Mean ktrans was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."|
1706068|NCT00902577|3137894|Other||Hazard Ratio (HR)|1.01||||0.355|2-Sided|95.0|0.98|1.04|||Regression, Cox|||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Hypoxic Volume (HV) was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."|
1706069|NCT00902577|3137894|Other||Hazard Ratio (HR)|0.93||||0.72|2-Sided|95.0|0.61|1.4|||Regression, Cox|||T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for PFS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.|
1706213|NCT00895947|3138483|Superiority or Other|||||||0.61||||||Proportion of subjects in each group with a confirmed viral respiratory infection|Chi-squared||||
1706070|NCT00902577|3137894|Other||Hazard Ratio (HR)|1.24||||0.33|2-Sided|95.0|0.8|1.91|||Regression, Cox|||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.~This marker was modeled with a univariate Cox regression model for Progression Free Survival time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."|
1706071|NCT00902577|3137895|Other||Hazard Ratio (HR)|0.99||||0.9007|2-Sided|95.0|0.91|1.09|||Regression, Cox|||Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the higher ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.|
1706072|NCT00902577|3137895|Other||Hazard Ratio (HR)|1.0||||0.97|2-Sided|95.0|0.79|1.26|||Regression, Cox|||Apparent Diffusion Coefficient (ADC) measures water diffusion through tissue. Cerebral infarction leads to diffusion restriction resulting in a low ADC signal in the infarcted area. A double Gaussian mixed model was fit to the ADC histogram and the mean of the lower ADC curve, was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.|
1706073|NCT00902577|3137895|Other||Hazard Ratio (HR)|1.07||||0.51|2-Sided|95.0|0.88|1.29|||Regression, Cox|||cerebral blood flow (CBF) maps were was normalized to the mean of the region of interest (ROI) in normal appearing white matter to produce the nCBF and provide another measure of vascular permeability and perfusion nCBF was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.|
1706074|NCT00902577|3137895|Other||Hazard Ratio (HR)|1.11||||0.31|2-Sided|95.0|0.9|1.37|||Regression, Cox|||Relative cerebral blood volume (RCBV) maps, computed from the integral of ∆R2*(t), were corrected for leakage effects and normalized to normal appearing white matter (nRCBV); nRCBV provides a measure of tumor vasculature and was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported.|
1706075|NCT00902577|3137895|Other||Hazard Ratio (HR)|1.32||||0.045|2-Sided|95.0|1.01|1.72|||Regression, Cox||HR reported per 0.01 increase|"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Median ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model.~Median ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."|
1706076|NCT00902577|3137895|Other||Hazard Ratio (HR)|1.17||||0.024|2-Sided|95.0|1.02|1.34|||Regression, Cox||HR reported per 0.01 increase|"ktrans reflects the rate of gadolinium moves from plasma to extravascular extracellular space (predominantly though blood flow and capillary leakage).~Mean ktrans were computed using a matrix-based linearization method to fit tissue ∆R1(t) to the extended Tofts model Mean ktrans was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."|
1706077|NCT00902577|3137895|Other||Hazard Ratio (HR)|1.0||||0.9|2-Sided|0.97|0.97|1.03|||Regression, Cox|||"Hypoxia Volume (HV) depicts the volume of tumor that has crossed the threshold for hypoxia.~Hypoxic Volume (HV) was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported."|
1706078|NCT00902577|3137895|Other||Hazard Ratio (HR)|1.16||||0.5|2-Sided|95.0|0.75|1.81|||Regression, Cox|||T/Bmax is the pixel in the tumor region with the maximum tumor:blood ratio (T/Bmax) and T/Bmax depicts the magnitude of the hypoxia TBmax was modeled with a univariate Cox regression model for OS time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald's statistic are reported. The study was designed to enroll 46 evaluable participants to detect a log hazard ratio of 1.279 for TBmax with HV as a covariate with a 50% event rate|
1706079|NCT00902577|3137895|Other||Hazard Ratio (HR)|1.54||||0.048|2-Sided|95.0|1.0|2.36|||Regression, Cox|||"FMISO selectively binds to hypoxic tissues so that SUVpeak within a region provides a measure of tumor hypoxia.:~This marker was modeled with a univariate Cox regression model for overall survival (OS) time. The hazard ratio, along with its 95% confidence interval and the p-value based on Wald’s statistic are reported."|
1706080|NCT00902538|3137905|Superiority or Other|||||||0.0063|||||||ANCOVA||||
1706081|NCT00902538|3137906|Superiority or Other|||||||0.0253|||||||ANCOVA||||
1706082|NCT00902538|3137907|Superiority or Other|||||||0.0412|||||||ANCOVA||||
1706083|NCT00902538|3137908|Superiority or Other|||||||0.0451|||||||ANCOVA||||
1706084|NCT00902538|3137909|Superiority or Other|||||||0.1611|||||||ANCOVA||||
1706085|NCT00902538|3137910|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1706086|NCT00902538|3137910|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1706087|NCT00902538|3137911|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1706088|NCT00902538|3137911|Superiority or Other||||||<|0.0009|||||||ANCOVA||||
1706089|NCT00902538|3137912|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1706090|NCT00902538|3137912|Superiority or Other||||||<|0.1939|||||||Cochran-Mantel-Haenszel||||
1706091|NCT00902538|3137913|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1706092|NCT00902538|3137913|Superiority or Other||||||<|0.0425|||||||ANCOVA||||
1706093|NCT00902538|3137914|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1706094|NCT00902538|3137914|Superiority or Other||||||<|0.1187|||||||ANCOVA||||
1706095|NCT00902486|3137944|Other|||||||0.1236|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 10 mg QD versus placebo.|
1706096|NCT00902486|3137944|Other|||||||0.0437|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 7 mg QD versus placebo.|
1706097|NCT00902486|3137944|Other|||||||0.1978|||||||Fisher Exact|||Sensitivity analysis for pairwise comparisons of 4 mg QD versus placebo.|
1706214|NCT00895947|3138484|Superiority or Other|||||||0.89||||||Proportion of subjects in each group reporting one or more days they skipped a planned activity|Chi-squared||||
1706098|NCT00902486|3137944|Superiority or Other||Odds Ratio (OR)|2.17||||0.0619|2-Sided|95.0|0.77|6.15|||Cochran-Armitage trend test||LOGISTIC regression model for odds ratio estimates : LOGIT(Response 0/1) = Treatment + Biologics|The prespecified primary analysis for ACR 20 was the Cochran-Armitage trend test looking for a dose-response relationship. The treatment effect was also assessed using a logistic regression model including background therapy (more than 8 weeks of biologics or not) and treatment.|
1706099|NCT00902330|3137962|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Spearman correlation coefficients were computed for the biomarkers. P-Values shown are not adjusted for multiple comparisons. The a priori threshold for statistical significance was P less than 0.05. This information applies to all rows listed in the table.|
1706100|NCT00902161|3138016|Superiority or Other||Least Squared Mean Treatment Difference|32.0||||0.005|2-Sided|95.0|15.0|49.0||There was only 1 primary hypothesis, so no multiplicity adjustment was required.|A linear mixed effect (LME) model|||The p-value is for testing the null hypothesis that the difference on Rt(65) between the [MK-0893 1g + Propranolol] vs. [PBO + Propranolol] >=60 min. If p-value < 0.05, then the null hypothesis is rejected at the significance level of 0.05, thus supporting the primary hypothesis that the treatment difference is less than 60 minutes.|
1706101|NCT00901459|3138047|Superiority or Other||Mean Difference (Final Values)|0.95|Standard Error of the Mean|0.44||0.09|2-Sided|95.0|0.52|1.39||A Holm correction to p values was made to control for type 1 error.|t-test, 2 sided|df=13|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 10Hz sfg condition (frequency control)and the corresponding craving change in the 1Hz moc condition (location control).|A pairwise t-test was performed to contrast the location control rTMS condition with the frequency control condition.|
1706102|NCT00901459|3138047|Superiority or Other||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.4||0.49|2-Sided|95.0|-0.64|1.22|||t-test, 2 sided|df=13|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 1Hz sfg condition (active)and the corresponding craving change in the 1Hz moc condition (location control).|A pairwise t-test was performed to contrast the active rTMS condition with the location control condition.|
1706103|NCT00901459|3138047|Superiority or Other||Mean Difference (Final Values)|1.47|Standard Error of the Mean|0.44||0.014|2-Sided|95.0|0.51|2.43||A Holm correction to p values was made to control for type 1 error.|t-test, 2 sided|df=14|The parameter estimated is the difference in craving change between smoking cues and neutral cues in the 10Hz sfg condition (Frequency control)and the corresponding craving change in the 1Hz sfg condition (active).|A pairwise t-test was performed to contrast the active rTMS condition with the frequency control condition.|
1706104|NCT00900666|3138091|Superiority or Other|||||||0.896|||||||ANOVA||||
1706105|NCT00900666|3138092|Non-Inferiority or Equivalence|a priori power calculation suggested N=26 for each group.||||||0.761||||||p<0.05 threshold|ANOVA|Correlations with walking speed and time since injury were initially performed to determine whether ANCOVA would be be more appropriate.||ANOVA|
1706106|NCT00900627|3138093|Superiority or Other||Hazard Ratio (HR)|1.15||||0.607|2-Sided|95.0|0.67|2.01||Statistical significance threshold at this analysis was 5%|Cox proportional hazard model|Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer|The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio <1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.|
1706107|NCT00900627|3138094|Superiority or Other||Odds Ratio (OR)|2.02||||0.026|2-Sided|95.0|1.09|3.75||Statistical significance threshold at this analysis was 5%|Logistic Regression|Logistic reg. model with terms for treatment, prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test|The odds Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a odds ratio <1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.|
1706108|NCT00900627|3138095|Superiority or Other||Hazard Ratio (HR)|1.08||||0.679|2-Sided|95.0|0.76|1.52||Statistical significance threshold at this analysis was 5%|Cox Proportional Hazard model|Cox PH test with terms for treatment , prior taxane, hormone receptor status, prior chemotherapy for breast cancer and AZD8931 diagnostic test|The Hazard Ratio is for AZD8931 40mg + paclitaxel / Placebo + paclitaxel, ie a hazard ratio <1 favours AZD8931 40mg + paclitaxel|Originally, 166 patients were to be randomised to observe at least 133 progression events, based on HR=0.67, 80% power, 2-sided 5% significant level and a median of 6 months for the placebo arm. After 190 patients were randomised, the analysis was agreed to be performed at an similar level of maturity (70%) as originally planned (72%), after approximately 133 events.|
1706109|NCT00900627|3138096|Superiority or Other||Maximum Tolerated Dose|40.0|||||||||||||Dosing started at 160mg. Based on the data seen, 240mg with 33% patients with DLTs, 120mg with 50% patients with DLTs, 80mg with 33% of patients with DLTs and 40mg with 0% patients with DLTs, 40mg was deemed the maximum tolerated dose.|A tolerated dose was defined as one where ≤25% of the patients experienced a DLT. If a dose was tolerated, an increased dose was to be investigated in another group of 3-6 evaluable patients. A non-tolerated dose was defined as one where >25% of the patients experience a DLT. If a dose was non tolerated, a decreased/intermediate dose could be investigated in another group of 3-6 evaluable patients. The maximum tolerated dose was determined as the maximum dose level that was defined as tolerated.|
1706110|NCT00899548|3138164|Superiority||Hazard Ratio (HR)|1.7||||0.001|2-Sided|95.0|1.18|2.45|||Gehan|Distributions compared between using the Gehan test, which gives more weight to early differences.|||
1706111|NCT00899548|3138167|Other||Cox Proportional Hazard|1.19||||0.001|2-Sided|95.0|1.07|1.32|||Regression, Cox|||Hazard ratio|
1706112|NCT00899548|3138168|Superiority||Hazard Ratio (HR)|1.76||||0.0002|2-Sided|95.0|1.23|2.52|||Gehan|Distributions compared between using the Gehan test, which gives more weight to early differences.|||
1706215|NCT00895947|3138484|Superiority or Other|||||||0.24||||||Proportion of subjects in each group reporting one or more days they took cold/flu medication|Chi-squared||||
1706113|NCT00899470|3138179|Non-Inferiority or Equivalence|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.042|||||2-Sided|90.0|0.986|1.102|||||For AUC(INF) of metformin, the point estimate and 90% confidence interval (CI) were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log[AUC(INF)] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.|
1706114|NCT00899470|3138179|Non-Inferiority or Equivalence|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted ), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.029|||||2-Sided|90.0|0.973|1.088|||||For AUC(INF) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log[AUC(INF)] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.|
1706115|NCT00899470|3138180|Non-Inferiority or Equivalence|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.042|||||2-Sided|90.0|0.981|1.108|||||For AUC(0-T) of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log[AUC(0-T)] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.|
1706116|NCT00899470|3138180|Non-Inferiority or Equivalence|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of metformin. If 5% difference then 20 subjects provided 95% power to conclude BE with respect to AUC(INF) of metformin.|Geometric Mean Ratio, Test vs. Reference|1.024|||||2-Sided|90.0|0.964|1.088|||||For AUC(0-T) of metformin the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log[AUC(0-T)] of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.|
1706117|NCT00899470|3138181|Non-Inferiority or Equivalence|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin.|Geometric Mean Ratio, Test vs. Reference|1.034|||||2-Sided|90.0|0.962|1.111|||||For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.|
1706118|NCT00899470|3138181|Non-Inferiority or Equivalence|If no difference between bioavailabilities of metformin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted and fed), then 20 subjects provided 98% power to conclude BE with respect to Cmax of metformin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of metformin, respectively.|Geometric Mean Ratio, Test vs. Reference|1.009|||||2-Sided|90.0|0.939|1.084|||||For Cmax of metformin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.|
1706119|NCT00899470|3138183|Non-Inferiority or Equivalence|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Means Ratio Test vs. Reference|1.022|||||2-Sided|95.0|0.985|1.06|||||For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log[AUC(INF)] of saxagliptin and metformin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.|
1706133|NCT00899353|3138198|Superiority or Other||Mean Difference (Final Values)|11.1|Standard Error of the Mean|3.1||0.04|2-Sided|95.0|0.5|21.8|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α< 0.05.~Analysis based on High Initial NFkB Activation Expressers."|
1706120|NCT00899470|3138183|Non-Inferiority or Equivalence|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.027|||||2-Sided|90.0|0.99|1.066|||||For AUC(INF) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log[AUC(INF)] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.|
1706121|NCT00899470|3138184|Non-Inferiority or Equivalence|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Means Ratio|1.021|||||2-Sided|90.0|0.986|1.058|||||For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log[AUC(0-T)] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.|
1706122|NCT00899470|3138184|Non-Inferiority or Equivalence|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin. If 5% difference then 20 subjects provided 99% power to conclude BE with respect to AUC(INF) of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.029|||||2-Sided|90.0|0.993|1.066|||||For AUC(0-T) of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: geometric mean of the Reference formulation in fasted state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted and fed states, linear mixed model analysis was performed on log[AUC(0-T)] of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.|
1706123|NCT00899470|3138185|Non-Inferiority or Equivalence|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fed condition), then 20 subjects provided 97% power to conclude BE with respect to Cmax of saxagliptin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of saxagliptin.|Geometric Mean Ratio, Test vs Reference|0.999|||||2-Sided|90.0|0.929|1.075|||||For Cmax of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fed state: the geometric mean of the Reference formulation in fed state|To demonstrate BE of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fed state, linear mixed model analysis was performed on log(Cmax) of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.|
1706124|NCT00899470|3138185|Non-Inferiority or Equivalence|If no difference between bioavailabilities of saxagliptin from FDC tablet vs. co-administration of saxagliptin tablet and metformin (fasted condition), then 20 subjects provided 97% power to conclude BE with respect to Cmax of saxagliptin. If 5% difference then 20 subjects provided 93% power to conclude BE with respect to Cmax of saxagliptin.|Geometric Mean Ratio, Test vs. Reference|1.011|||||2-Sided|90.0|0.94|1.088|||||For Cmax of saxagliptin, the point estimate and 90% CI were calculated for the ratio of the geometric mean of the Test formulation in fasted state: the geometric mean of the Reference formulation in fasted state|To demonstrate bioequivalence (BE) of FDC tablets (Test) versus co-administration of saxagliptin and metformin IR tablets (Reference) formulations in fasted state, linear mixed model analysis was performed on log(Cmax) of saxagliptin. Factors in the model were sequence, period and treatment as fixed effects, and participant within sequence as a random effect.|
1706125|NCT00899392|3138189|Superiority or Other|||||||0.0053|||||||t-test, 2 sided||||
1706126|NCT00899392|3138190|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|paired|||
1706127|NCT00899392|3138191|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Mann Whitney Test-non parametric|
1706128|NCT00899392|3138192|Superiority or Other||||||<|0.0001||||||Student's t test|t-test, 2 sided||||
1706129|NCT00899353|3138198|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|1.2||0.98|2-Sided|95.0|-6.6|5.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."|
1706130|NCT00899353|3138198|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.3||0.98|2-Sided|95.0|-0.8|1.0|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."|
1706131|NCT00899353|3138198|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.7||0.88|2-Sided|95.0|-3.5|2.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."|
1706132|NCT00899353|3138198|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.4||1|2-Sided|95.0|-1.5|1.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α< 0.05.~Analysis based on Low Initial NFkB Activation Expressers."|
1706134|NCT00899353|3138198|Superiority or Other||Mean Difference (Final Values)|12.0|Standard Error of the Mean|2.8||0.03|2-Sided|95.0|1.6|22.3|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α< 0.05.~Analysis based on High Initial NFkB Activation Expressers."|
1706135|NCT00899353|3138198|Superiority or Other||Mean Difference (Final Values)|6.3|Standard Error of the Mean|3.1||0.32|2-Sided|95.0|-4.1|16.8|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α< 0.05.~Analysis based on High Initial NFkB Activation Expressers."|
1706136|NCT00899353|3138198|Superiority or Other||Mean Difference (Final Values)|5.3|Standard Error of the Mean|3.7||0.61|2-Sided|95.0|-6.5|17.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α< 0.05.~Analysis based on High Initial NFkB Activation Expressers."|
1706137|NCT00899353|3138198|Superiority or Other||Mean Difference (Final Values)|5.8|Standard Error of the Mean|2.4||0.17|2-Sided|95.0|-1.6|13.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α< 0.05.~Analysis based on global response."|
1706138|NCT00899353|3138198|Superiority or Other||Mean Difference (Final Values)|6.6|Standard Error of the Mean|2.3||0.08|2-Sided|95.0|-0.6|13.7|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α< 0.05.~Analysis based on global response."|
1706139|NCT00899353|3138198|Superiority or Other||Mean Difference (Final Values)|3.0|Standard Error of the Mean|2.5||0.75|2-Sided|95.0|-4.6|10.7|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α< 0.05.~Analysis based on global response."|
1706140|NCT00899353|3138198|Superiority or Other||Mean Difference (Final Values)|3.1|Standard Error of the Mean|2.7||0.78|2-Sided|95.0|-5.0|11.2|||ANOVA|Games-Howell Correction was applied to adjust for unequal variances, unequal sample size and for non-parametric distribution.||"Omnibus analysis. Statistical significance was determined by Games Howell Multiple Comparison test. Significance was determined as α< 0.05.~Analysis based on global response."|
1706141|NCT00898807|3138202|Superiority or Other||Odds Ratio (OR)|2.13||||0.007|2-Sided|95.0|1.23|3.69||All p-values are two-sided and p <0.05 was the threshold for statistical significance. No adjustments were made for multiple comparisons.|Proportional odds|estimated treatment effect from the proportional odds model|Positive numbers favors citalopram.|Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the CGIC proportional odds analysis, the study was designed to have power greater than 80% to detect a difference of 20% between citalopram and placebo in the proportions of patients who improve (or worsen).|
1706142|NCT00898807|3138203|Superiority or Other||Mean Difference (Net)|-0.93||||0.036|2-Sided|95.0|-1.8|-0.06||P-value was not adjusted for multiple comparisons. All p-values are two-sided and p<0.05 was the threshold for statistical significance.|Mixed Models Analysis|Mixed effects model w/ random intercept for patient, visit indicator, treatment by visit interactions and adjusted for baseline NBRS-A & cognition.|Negative numbers favor citalopram group.|Primary assessment of efficacy was based on intention-to-treat comparison of the difference in the NBRS-A scores at week 9 and comparison at week 9 for the CGIC. For the NBRS-A, the study was designed to have 85% power to detect a standardized difference at week 9 of 40% for citalopram compared to placebo at week 9.|
1706143|NCT00897715|3138224|Superiority or Other (legacy)|||||||0.01||||||0.05 is the a priori threshold for statistical significance|ANCOVA||||
1706144|NCT00897715|3138225|Superiority or Other (legacy)|||||||0.03||||||0.05 is the a priori threshold for statistical significance|ANCOVA|||For the primary specific aim, we will compare the mean percent change on hsCRP between the intervention arm and the placebo arm using linear regression. We anticipate that the intervention will conservatively decrease hsCRP by 54%; whereas, placebo will have no effect. Accordingly, we have estimated that we will need 24 subjects in the experimental arm and 24 controls to have an 80% power, with an alpha of 0.05 to detect the above mentioned effect size.|
1706145|NCT00897390|3138243|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.964|||||2-Sided|90.0|0.891|1.042||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)] and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.|
1706165|NCT00896389|3138318|Other|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05|||||||Chi-squared|Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.|
1706216|NCT00895947|3138484|Superiority or Other|||||||0.54||||||Proportion of subjects in each group reporting one or more days they visited the pharmacy|Chi-squared||||
1706146|NCT00897390|3138243|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.937|||||2-Sided|90.0|0.864|1.016||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)] and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.|
1706147|NCT00897390|3138244|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.974||||||90.0|0.92|1.032||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)] and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.|
1706148|NCT00897390|3138244|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.962||||||90.0|0.906|1.02||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)] and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.|
1706149|NCT00897390|3138245|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.966||||||90.0|0.915|1.02||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)] and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.|
1706150|NCT00897390|3138245|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.974|||||2-Sided|90.0|0.921|1.03||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)] and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.|
1706151|NCT00897390|3138248|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.987|||||2-Sided|90.0|0.9|1.083||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)] and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.|
1706152|NCT00897390|3138248|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.077|||||2-Sided|90.0|0.978|1.185||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)] and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.|
1706178|NCT00896363|3138342|Superiority or Other||Mean Difference (Net)|0.72|||||2-Sided|90.0|-0.94|2.37|||||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 1 mg on Day 14|
1706179|NCT00896363|3138343|Superiority or Other||Mean Difference (Net)|0.77|||||2-Sided|90.0|-0.93|2.48|||||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 3 mg on Day 42|
1706153|NCT00897390|3138249|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.992|||||2-Sided|90.0|0.962|1.022||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)] and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.|
1706154|NCT00897390|3138249|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.045|||||2-Sided|90.0|1.013|1.077||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)] and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.|
1706155|NCT00897390|3138251|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|0.988|||||2-Sided|90.0|0.958|1.019||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)] and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.|
1706156|NCT00897390|3138251|Non-Inferiority or Equivalence|Point estimates and 90% confidence intervals were calculated for the Arm B to Arm A and Arm D to Arm C ratios of geometric means for Cmax, AUC(INF) and AUC(0-T) of saxagliptin and metformin, respectively. Potency-corrected results were also provided. Bioequivalence will be concluded if the 90% confidence intervals for the test-to-reference ratios of geometric means are entirely contained within 80% to 125% for both Cmax and AUC(INF). No adjustments were made for multiplicity.|adjusted geometric mean|1.042|||||2-Sided|90.0|1.009|1.075||||||To demonstrate the bioequivalence of formulation (FDC tablet versus co-administration of separate saxagliptin tablet and metformin IR tablet) in the fasted and fed state, linear mixed model analyses were performed on log(Cmax), log[AUC(INF)] and log[AUC(0-T)] of saxagliptin and metformin, respectively. The factors in the model were sequence, period and treatment as fixed effects and subject within sequence as a random effect.|
1706157|NCT00896779|3138259|Superiority or Other|||||||0.06|||||||t-test, 2 sided||||
1706158|NCT00896779|3138259|Superiority or Other|||||||0.02|||||||t-test, 2 sided||||
1706159|NCT00896532|3138272|Superiority||LS Mean Difference from Placebo|8.5|||<|0.0001|2-Sided|95.0|7.3|9.8||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.|
1706160|NCT00896532|3138272|Superiority||LS Mean Difference from Placebo|7.4|||<|0.0001|2-Sided|95.0|6.1|8.7||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.|
1706161|NCT00896532|3138272|Superiority||LS Mean Difference from placebo|5.6|||<|0.0001|2-Sided|95.0|4.3|6.9||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.|
1706162|NCT00896532|3138272|Superiority||LS Mean Difference from Placebo|8.7|||<|0.0001|2-Sided|95.0|7.5|9.9||P-value is adjusted by the Hochberg procedure for comparisons to placebo.|Linear Mixed Effects Model|||A linear mixed effects model was fit with the percent change from baseline to months 3, 6 and 12 in BMD of the lumbar spine as the dependent variable and baseline BMD, machine type, interaction of baseline BMD and machine type, geographic region (Latin America, North America, Europe), visit, treatment regimen (categorical), interaction of treatment regimen and visit as the independent variables.|
1706163|NCT00896441|3138315|Other||||||<|0.006|||||||t-test, 2 sided|Single group t-test|||
1706164|NCT00896441|3138317|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|One sample t-test|||
1706180|NCT00896363|3138343|Superiority or Other||Mean Difference (Net)|0.66|||||2-Sided|90.0|-1.1|2.42|||||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 1 mg on Day 42|
1706181|NCT00896363|3138343|Superiority or Other||Mean Difference (Net)|0.51|||||2-Sided|90.0|-0.73|1.75|||||The point estimate was calculated as least square mean difference (net values) of BECH 6 scale|Comparison of placebo and GSK163090 3 mg on Day 14|
1706361|NCT00895583|3138560|Superiority or Other|||||||0.517||||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Month 24|
1706166|NCT00896389|3138319|Other|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.|
1706167|NCT00896389|3138320|Other|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.|
1706168|NCT00896389|3138321|Other|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.|
1706169|NCT00896389|3138322|Other|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.|
1706170|NCT00896389|3138323|Other|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.|
1706171|NCT00896389|3138324|Other|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.|
1706172|NCT00896389|3138325|Other|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35909607 genotype group and phenotypes collected in this study.|
1706173|NCT00896389|3138326|Other|Association between genotype and phenotype were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||<|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared||||
1706174|NCT00896389|3138327|Other|Association between genotypes and phenotypes were tested using a linear mixed model, coding genotype as an independent variable with an additive genetic effect, and including age, age^2, and sex as covariates in the model. All association analyses were run using the Mixed Models for Pedigree Analysis (MMAP) software program to account for the relatedness among study subjects. MMAP User Guide is available from http://edn.som.umaryland.edu/mmap/index.php.|||||>|0.05||||||Because no P-values less than 0.05 was observed, we did not adjust them for multiple comparison to avoid false positives.|Chi-squared|||Null hypothesis: There is no association between STK39 SNP rs35929607 genotype group and phenotypes collected in this study.|
1706175|NCT00896363|3138342|Superiority or Other||Mean Difference (Net)|0.81|||||2-Sided|90.0|-1.22|2.85|||||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 3 mg on Day 42|
1706176|NCT00896363|3138342|Superiority or Other||Mean Difference (Net)|0.84|||||2-Sided|90.0|-1.22|2.9|||||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 1 mg on Day 42|
1706177|NCT00896363|3138342|Superiority or Other||Mean Difference (Net)|-0.44|||||2-Sided|90.0|-2.1|1.21|||||The point estimate was calculated as least square mean difference (net values) of QIDS-SR scale|Comparison of placebo and GSK163090 3 mg on Day 14|
1706362|NCT00895583|3138560|Superiority or Other|||||||0.326||||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Month 12|
1706183|NCT00896363|3138344|Superiority or Other||Mean Difference (Net)|1.66|||||2-Sided|90.0|-1.81|5.13|||||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 3 mg on Day 42|
1706184|NCT00896363|3138344|Superiority or Other||Mean Difference (Net)|1.57|||||2-Sided|90.0|-2.01|5.14|||||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 1 mg on Day 42|
1706185|NCT00896363|3138344|Superiority or Other||Mean Difference (Net)|0.33|||||2-Sided|90.0|-2.12|2.78|||||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 3 mg on Day 14|
1706186|NCT00896363|3138344|Superiority or Other||Mean Difference (Net)|0.85|||||2-Sided|90.0|-1.62|3.32|||||The point estimate was calculated as least square mean difference (net values) of HAMD17|Comparison of placebo and GSK163090 1 mg on Day 14|
1706187|NCT00896337|3138408|Superiority or Other||9-month major adverse event rate|3.4|||<|0.0001|2-Sided|95.0|0.9|8.5||A one-sided exact-test was used to test the hypothesis that the primary endpoint rate in the Epic-treated cohort is less than the predefined performance goal of 17.0%.|One-sided exact-test|||MAE rate was compared to a predefined performance goal of 17.0%, based on literature-derived expected rate of 8.0% for iliac stenting plus a 9.0% margin. Study had 87% statistical power to show the MAE rate (accounting for 9-month attrition of <=15%) is less than the performance goal, assuming a 9-month MAE rate of 8.0%. If the exact one-sided 95% upper confidence bound of the observed rate is lower than the performance goal, the Epic stent would be considered to have acceptable performance.|
1706188|NCT00896298|3138409|Superiority|||||||0.0256|||||||Mixed Models Analysis||||
1706189|NCT00896298|3138410|Superiority|||||||0.68|||||||Mixed Models Analysis||||
1706190|NCT00896298|3138411|Superiority|||||||0.71|||||||Mixed Models Analysis||||
1706191|NCT00896298|3138412|Superiority|||||||0.2572|||||||Mixed Models Analysis||||
1706192|NCT00896233|3138415|Superiority or Other||ICC|0.94|||||2-Sided|90.0|0.88|1.0||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.|
1706193|NCT00896233|3138415|Superiority or Other||ICC|0.93|||||2-Sided|90.0|0.87|1.0||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.|
1706194|NCT00896233|3138415|Superiority or Other||ICC|0.88|||||2-Sided|90.0|0.78|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.|
1706195|NCT00896233|3138415|Superiority or Other||ICC|0.9|||||2-Sided|90.0|0.8|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.|
1706196|NCT00896233|3138416|Superiority or Other||ICC|0.86|||||2-Sided|90.0|0.75|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.|
1706197|NCT00896233|3138416|Superiority or Other||ICC|0.88|||||2-Sided|90.0|0.78|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Individual ROI.|
1706198|NCT00896233|3138416|Superiority or Other||ICC|0.85|||||2-Sided|90.0|0.71|0.98||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.|
1706199|NCT00896233|3138416|Superiority or Other||ICC|0.9|||||2-Sided|90.0|0.81|0.99||||||ICC for measures of liver stiffness obtained by MRE (i.e., average over all 4 slices of the maximum stiffness for each slice) with respect to repeatability (precision) of multiple MRE assessments. This pertains to the Common ROI.|
1706200|NCT00896051|3138455|Superiority or Other||Least Squares (LS) Means Ratio|0.99|||||2-Sided|90.0|0.81|1.21||||||Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)|
1706201|NCT00896051|3138456|Superiority or Other||Least Squares (LS) Means Ratio|1.05|||||2-Sided|90.0|0.86|1.27||||||Parameter: maximum plasma concentration (Cmax)|
1706202|NCT00896051|3138456|Superiority or Other||Least Squares (LS) Means Ratio|0.91|||||2-Sided|90.0|0.63|1.33||||||Parameter: Minimum plasma concentration (Cmin)|
1706203|NCT00896051|3138457|Superiority or Other||Least Squares (LS) Means Ratio|0.96|||||2-Sided|90.0|0.76|1.22||||||Parameter: area under the plasma concentration-time curve from time of intake to 24 hours after dosing (AUC24hr)|
1706204|NCT00896051|3138458|Superiority or Other||Least Squares (LS) Mean Ratio|0.96|||||2-Sided|90.0|0.8|1.16||||||Parameter: maximum plasma concentration (Cmax)|
1706205|NCT00896051|3138458|Superiority or Other||Least Squares (LS) Means Ratio|0.82|||||2-Sided|90.0|0.55|1.22||||||Parameter: minimum plasma concentration (Cmin)|
1706206|NCT00895947|3138482|Superiority or Other|||||||0.6||||||Proportion of subjects with moderate/severe afebrile acute respiratory illness during treatment|Chi-squared||||
1706207|NCT00895947|3138482|Superiority or Other|||||||0.03||||||Proportion of subjects with moderate/severe febrile acute respiratory illness during treatment|Chi-squared||||
1706208|NCT00895947|3138482|Superiority or Other|||||||0.06||||||Proportion of subjects meeting with moderate/severe acute respiratory illness during treatment|Chi-squared||||
1706209|NCT00895947|3138482|Superiority or Other|||||||0.54||||||Proportion of subjects meeting the definition of acute respiratory illness during treatment|Chi-squared||||
1706210|NCT00895947|3138483|Superiority or Other|||||||0.03||||||Proportion of subjects in each group with a moderate/severe viral respiratory infection other than influenza|Chi-squared||||
1706211|NCT00895947|3138483|Superiority or Other|||||||0.03||||||Proportion of subjects in each group with a moderate/severe influenza infection|Chi-squared||||
1706212|NCT00895947|3138483|Superiority or Other|||||||0.003||||||Proportion of subjects in each group with a moderate/severe viral respiratory infection|Chi-squared||||
1706217|NCT00895947|3138484|Superiority or Other|||||||1||||||Proportion of subjects in each group reporting one or more days they visited the doctor|Chi-squared||||
1706218|NCT00895947|3138484|Superiority or Other|||||||0.88||||||Proportion of subjects in each group reporting one or more days they missed work|Chi-squared||||
1706219|NCT00895947|3138484|Superiority or Other|||||||0.66||||||Proportion of subjects in each group reporting one or more days they felt sick|Chi-squared||||
1706220|NCT00895947|3138485|Superiority or Other|||||||0.32||||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to live personal life|Chi-squared||||
1706221|NCT00895947|3138485|Superiority or Other|||||||0.2||||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to interact with others|Chi-squared||||
1706222|NCT00895947|3138485|Superiority or Other|||||||0.2||||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work inside the home|Chi-squared||||
1706223|NCT00895947|3138485|Superiority or Other|||||||0.25||||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to work outside the home|Chi-squared||||
1706224|NCT00895947|3138485|Superiority or Other|||||||0.26||||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to perform daily activities|Chi-squared||||
1706225|NCT00895947|3138485|Superiority or Other|||||||0.48||||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to walk, climb stairs and exercise|Chi-squared||||
1706226|NCT00895947|3138485|Superiority or Other|||||||0.66||||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to breathe easily|Chi-squared||||
1706227|NCT00895947|3138485|Superiority or Other|||||||0.15||||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to sleep well|Chi-squared||||
1706228|NCT00895947|3138485|Superiority or Other|||||||0.39||||||Proportion of subjects reporting one of more days that cold/flu symptoms impacted ability to think clearly|Chi-squared||||
1706229|NCT00895947|3138486|Superiority or Other|||||||0.07||||||Proportion of subjects reporting moderate to severe sore throat|Chi-squared||||
1706230|NCT00895947|3138486|Superiority or Other|||||||0.04||||||Proportion of subjects reporting moderate to severe head congestion|Chi-squared||||
1706231|NCT00895947|3138486|Superiority or Other|||||||0.03||||||Proportion of subjects reporting moderate to severe feverishness|Chi-squared||||
1706232|NCT00895947|3138486|Superiority or Other|||||||0.16||||||Proportion of subjects reporting any cold/flu symptoms during treatment|Chi-squared||||
1706233|NCT00895947|3138487|Superiority or Other|||||||0.99||||||Comparison of ILI incidence in female subjects|Chi-squared||||
1706234|NCT00895947|3138487|Superiority or Other|||||||0.03||||||Comparison of ILI incidence in male subjects|Chi-squared||||
1706235|NCT00895947|3138487|Superiority or Other|||||||0.45||||||Comparison of ILI incidence in subjects not vaccinated against seasonal influenza prior to enrollment|Chi-squared||||
1706236|NCT00895947|3138487|Superiority or Other|||||||0.01||||||Comparison of ILI incidence in subjects vaccinated against seasonal influenza prior to enrollment.|Chi-squared||||
1706237|NCT00895947|3138487|Superiority or Other|||||||0.32||||||Comparison of ILI in subjects age < 50 at baseline|Chi-squared||||
1706238|NCT00895947|3138487|Superiority or Other|||||||0.01||||||Comparision of ILI incidence in subjects age 50 and older at baseline.|Chi-squared||||
1706239|NCT00895947|3138487|Superiority or Other|||||||0.25||||||Overall comparison of treatment groups for incidence of ILI|Chi-squared||||
1706240|NCT00895895|3138492|Superiority or Other||Odds Ratio (OR)|2.61||||0.037|2-Sided|95.0|1.06|6.42|||Regression, Logistic||||
1706241|NCT00895895|3138492|Superiority or Other||Odds Ratio (OR)|1.8||||0.216|2-Sided|95.0|0.71|4.55|||Regression, Logistic||||
1706242|NCT00895895|3138492|Superiority or Other||Odds Ratio (OR)|1.16||||0.77|2-Sided|95.0|0.42|3.19|||Regression, Logistic||||
1706243|NCT00895895|3138492|Superiority or Other||Odds Ratio (OR)|0.73||||0.581|2-Sided|95.0|0.24|2.22|||Regression, Logistic||||
1706244|NCT00895895|3138493|Superiority or Other||Mean Difference (Final Values)|-25.5||||0.422|2-Sided|95.0|-87.9|36.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706245|NCT00895895|3138493|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.991|2-Sided|95.0|-61.5|60.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706246|NCT00895895|3138493|Superiority or Other||Mean Difference (Final Values)|4.2||||0.894|2-Sided|95.0|-57.5|65.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706247|NCT00895895|3138493|Superiority or Other||Mean Difference (Final Values)|22.5||||0.481|2-Sided|95.0|-40.2|85.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706248|NCT00895895|3138494|Superiority or Other||Mean Difference (Final Values)|33.8||||0.378|2-Sided|95.0|-41.5|109.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706249|NCT00895895|3138494|Superiority or Other||Mean Difference (Final Values)|11.2||||0.766|2-Sided|95.0|-62.9|85.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706250|NCT00895895|3138494|Superiority or Other||Mean Difference (Final Values)|20.0||||0.598|2-Sided|95.0|-54.6|94.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706363|NCT00895583|3138560|Superiority or Other|||||||0.429||||||Alpha was unadjusted.|Fisher Exact|||Anti-hypertensives, Baseline|
1708388|NCT00858208|3143286|Superiority or Other|||||||0.2749|||||||paired t-test|||Change from baseline at Week 102|
1706251|NCT00895895|3138494|Superiority or Other||Mean Difference (Final Values)|71.2||||0.066|2-Sided|95.0|-4.7|147.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706252|NCT00895895|3138495|Superiority or Other||Mean Difference (Final Values)|-10.9||||0.633|2-Sided|95.0|-55.6|33.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706253|NCT00895895|3138495|Superiority or Other||Mean Difference (Final Values)|5.7||||0.797|2-Sided|95.0|-38.1|49.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706254|NCT00895895|3138495|Superiority or Other||Mean Difference (Final Values)|21.0||||0.352|2-Sided|95.0|-23.3|65.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706255|NCT00895895|3138495|Superiority or Other||Mean Difference (Final Values)|31.1||||0.175|2-Sided|95.0|-13.9|76.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706256|NCT00895895|3138496|Superiority or Other||Mean Difference (Final Values)|17.6||||0.578|2-Sided|95.0|-44.6|79.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706257|NCT00895895|3138496|Superiority or Other||Mean Difference (Final Values)|8.6||||0.783|2-Sided|95.0|-52.6|69.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706258|NCT00895895|3138496|Superiority or Other||Mean Difference (Final Values)|21.8||||0.488|2-Sided|95.0|-40.0|83.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706259|NCT00895895|3138496|Superiority or Other||Mean Difference (Final Values)|60.9||||0.056|2-Sided|95.0|-1.6|123.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706260|NCT00895895|3138497|Superiority or Other||Mean Difference (Final Values)|0.4||||0.525|2-Sided|95.0|-0.7|1.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706261|NCT00895895|3138497|Superiority or Other||Mean Difference (Final Values)|0.1||||0.893|2-Sided|95.0|-1.0|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706262|NCT00895895|3138497|Superiority or Other||Mean Difference (Final Values)|0.6||||0.264|2-Sided|95.0|-0.5|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706263|NCT00895895|3138497|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.032|2-Sided|95.0|-2.3|-0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706264|NCT00895895|3138498|Superiority or Other||Mean Difference (Final Values)|2.2||||0.386|2-Sided|95.0|-2.8|7.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706265|NCT00895895|3138498|Superiority or Other||Mean Difference (Final Values)|3.7||||0.139|2-Sided|95.0|-1.2|8.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706266|NCT00895895|3138498|Superiority or Other||Mean Difference (Final Values)|3.6||||0.145|2-Sided|95.0|-1.3|8.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706267|NCT00895895|3138498|Superiority or Other||Mean Difference (Final Values)|2.8||||0.267|2-Sided|95.0|-2.2|7.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706268|NCT00895895|3138499|Superiority or Other||Mean Difference (Final Values)|230.6||||0.505|2-Sided|95.0|-449.7|910.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706269|NCT00895895|3138499|Superiority or Other||Mean Difference (Final Values)|141.3||||0.676|2-Sided|95.0|-522.1|804.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706270|NCT00895895|3138499|Superiority or Other||Mean Difference (Final Values)|-926.6||||0.007|2-Sided|95.0|-1596.9|-256.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706271|NCT00895895|3138499|Superiority or Other||Mean Difference (Final Values)|-60.4||||0.861|2-Sided|95.0|-739.7|618.8|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706272|NCT00895895|3138500|Superiority or Other||Mean Difference (Final Values)|0.3||||0.543|2-Sided|95.0|-0.6|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706400|NCT00895583|3138578|Superiority or Other||Odds Ratio (OR)|0.7||||0.239|2-Sided|95.0|0.4|1.3||Two-sided alpha equals (=) 0.05.|Fisher Exact||||
1706273|NCT00895895|3138500|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.179|2-Sided|95.0|-1.4|0.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706274|NCT00895895|3138500|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.74|2-Sided|95.0|-1.0|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706275|NCT00895895|3138500|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.154|2-Sided|95.0|-1.5|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706276|NCT00895895|3138501|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.28|2-Sided|95.0|-4.0|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706277|NCT00895895|3138501|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.89|2-Sided|95.0|-2.7|2.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706278|NCT00895895|3138501|Superiority or Other||Mean Difference (Final Values)|0.0||||0.988|2-Sided|95.0|-2.6|2.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706279|NCT00895895|3138501|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.956|2-Sided|95.0|-2.7|2.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706280|NCT00895895|3138502|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.215|2-Sided|95.0|-3.0|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706281|NCT00895895|3138502|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.312|2-Sided|95.0|-2.7|0.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706282|NCT00895895|3138502|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.763|2-Sided|95.0|-2.1|1.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706283|NCT00895895|3138502|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.428|2-Sided|95.0|-2.6|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706284|NCT00895895|3138503|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.853|2-Sided|95.0|-1.3|1.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706285|NCT00895895|3138503|Superiority or Other||Mean Difference (Final Values)|0.5||||0.417|2-Sided|95.0|-0.7|1.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706286|NCT00895895|3138503|Superiority or Other||Mean Difference (Final Values)|0.2||||0.781|2-Sided|95.0|-1.0|1.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706287|NCT00895895|3138503|Superiority or Other||Mean Difference (Final Values)|0.5||||0.373|2-Sided|95.0|-0.6|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706288|NCT00895895|3138504|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.665|2-Sided|95.0|-0.8|0.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706289|NCT00895895|3138504|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.216|2-Sided|95.0|-1.1|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706290|NCT00895895|3138504|Superiority or Other||Mean Difference (Final Values)|0.0||||0.956|2-Sided|95.0|-0.7|0.6|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706291|NCT00895895|3138504|Superiority or Other||Mean Difference (Final Values)|0.0||||0.953|2-Sided|95.0|-0.7|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706292|NCT00895895|3138505|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.518|2-Sided|95.0|-1.3|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706293|NCT00895895|3138505|Superiority or Other||Mean Difference (Final Values)|0.2||||0.678|2-Sided|95.0|-0.8|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706294|NCT00895895|3138505|Superiority or Other||Mean Difference (Final Values)|0.2||||0.63|2-Sided|95.0|-0.8|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706295|NCT00895895|3138505|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.34|2-Sided|95.0|-1.5|0.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706296|NCT00895895|3138506|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.611|2-Sided|95.0|-0.4|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706297|NCT00895895|3138506|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.553|2-Sided|95.0|-0.4|0.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706298|NCT00895895|3138506|Superiority or Other||Mean Difference (Final Values)|0.0||||0.993|2-Sided|95.0|-0.3|0.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706299|NCT00895895|3138506|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.251|2-Sided|95.0|-0.5|0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706300|NCT00895895|3138507|Superiority or Other||Mean Difference (Final Values)|0.8||||0.785|2-Sided|95.0|-4.8|6.4|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706301|NCT00895895|3138507|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.712|2-Sided|95.0|-6.6|4.5|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706302|NCT00895895|3138507|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.886|2-Sided|95.0|-6.0|5.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706303|NCT00895895|3138507|Superiority or Other||Mean Difference (Final Values)|1.7||||0.553|2-Sided|95.0|-3.9|7.3|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706304|NCT00895895|3138508|Superiority or Other|||||||0.751|||||||Cochran-Mantel-Haenszel||||
1706305|NCT00895895|3138508|Superiority or Other|||||||0.087|||||||Cochran-Mantel-Haenszel||||
1706306|NCT00895895|3138508|Superiority or Other|||||||0.532|||||||Cochran-Mantel-Haenszel||||
1706307|NCT00895895|3138508|Superiority or Other|||||||0.682|||||||Cochran-Mantel-Haenszel||||
1706308|NCT00895895|3138508|Superiority or Other|||||||0.265|||||||Cochran-Mantel-Haenszel||||
1706309|NCT00895895|3138509|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.426|2-Sided|95.0|-4.1|1.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706310|NCT00895895|3138509|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.246|2-Sided|95.0|-4.6|1.2|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706311|NCT00895895|3138509|Superiority or Other||Mean Difference (Final Values)|-2.9||||0.054|2-Sided|95.0|-5.8|0.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706312|NCT00895895|3138509|Superiority or Other||Mean Difference (Final Values)|0.1||||0.931|2-Sided|95.0|-2.8|3.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706313|NCT00895895|3138510|Superiority or Other||Mean Difference (Final Values)|3.4||||0.06|2-Sided|95.0|-0.1|6.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706314|NCT00895895|3138510|Superiority or Other||Mean Difference (Final Values)|2.5||||0.16|2-Sided|95.0|-1.0|6.0|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706315|NCT00895895|3138510|Superiority or Other||Mean Difference (Final Values)|0.2||||0.91|2-Sided|95.0|-3.3|3.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706316|NCT00895895|3138510|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.367|2-Sided|95.0|-5.2|1.9|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706317|NCT00895895|3138511|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.258|2-Sided|95.0|-2.6|0.7|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706318|NCT00895895|3138511|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.52|2-Sided|95.0|-2.2|1.1|||Mixed Models Analysis|Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706319|NCT00895895|3138511|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.849|2-Sided|95.0|-1.8|1.5|||Mixed Models Analysis|Mixed Model with repeated measures: change equals (=) MMSE Japan baseline baseline * visit visit treatment treatment * visit.||Analysis of adjusted difference in change from baseline.|
1706320|NCT00895895|3138511|Superiority or Other||Mean Difference (Final Values)|0.7||||0.424|2-Sided|95.0|-1.0|2.3|||Mixed Models Analysis|Mixed Model with repeated measures: change=Mini Mental State Examination (MMSE) Japan baseline baseline times(*)visit visit treatment treatment*visit.||Analysis of adjusted difference in change from baseline.|
1706364|NCT00895583|3138561|Superiority or Other||Difference in Adjusted Means|0.37|Standard Error of the Mean|0.16||0.028|2-Sided|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||Triglycerides, Month 24|
1706321|NCT00895622|3138534|Other||Kappa statistic|0.79|||<|0.0001|2-Sided|95.0|0.71|0.87|||Z test|||"The Kappa (κ) coefficient was used to assess the measure of agreement between the reviewers. κ can be interpreted as follows (κ / Agreement):~< 0 / Less than chance agreement; 0.01-0.20 / Slight agreement; 0.21-0.40 / Fair agreement; 0.41-0.60 / Moderate agreement; 0.61-0.80 / Substantial agreement; 0.81-0.99 / Almost perfect agreement.~The asymptotic test of the null hypothesis: κ=0 will be performed using the Z-statistic to determine the strength of agreement."|
1706322|NCT00895583|3138542|Superiority or Other|||||||0.158|||||||Fisher Exact||||
1706323|NCT00895583|3138543|Superiority or Other|||||||0.276|||||||Fisher Exact||||
1706324|NCT00895583|3138544|Superiority or Other|||||||1|||||||Fisher Exact||||
1706325|NCT00895583|3138545|Superiority or Other|||||||0.129|||||||Fisher Exact||||
1706326|NCT00895583|3138546|Superiority or Other|||||||1||||||Alpha was unadjusted.|Fisher Exact|||Insulin (24-Month)|
1706327|NCT00895583|3138546|Superiority or Other|||||||0.386||||||Alpha was unadjusted.|Fisher Exact|||Non-insulin (24-Month)|
1706328|NCT00895583|3138546|Superiority or Other|||||||1||||||Alpha was unadjusted.|Fisher Exact|||Non-insulin (12-Month)|
1706329|NCT00895583|3138546|Superiority or Other|||||||1||||||Alpha was unadjusted.|Fisher Exact|||Insulin (12-Month)|
1706330|NCT00895583|3138547|Superiority or Other|||||||1||||||Alpha was unadjusted.|Fisher Exact|||New onset at 2 years (from On-Therapy Month 12 to On-Therapy Month 24)|
1706331|NCT00895583|3138547|Superiority or Other|||||||0.012||||||Alpha was unadjusted.|Fisher Exact|||New onset at 1 year (from baseline up to On-Therapy Month 12)|
1706332|NCT00895583|3138547|Superiority or Other|||||||0.025||||||Alpha was unadjusted.|Fisher Exact|||New onset (from baseline up to On-Therapy Month 24)|
1706333|NCT00895583|3138548|Superiority or Other||Difference in Adjusted Means|-0.22|Standard Error of the Mean|0.23||0.337|2-Sided|||||Alpha was unadjusted.|ANCOVA||||
1706334|NCT00895583|3138549|Superiority or Other||Difference in Adjusted Means|216.29|Standard Error of the Mean|198.84||0.279|2-Sided|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.|||
1706335|NCT00895583|3138550|Superiority or Other||Difference in Adjusted Means|0.08|Standard Error of the Mean|1.48||0.955|2-Sided|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.|||
1706336|NCT00895583|3138551|Superiority or Other||Difference in Adjusted Means|-0.56|Standard Error of the Mean|1.18||0.637|2-Sided|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.|||
1706337|NCT00895583|3138552|Superiority or Other||Difference in Adjusted Means|-0.45|Standard Error of the Mean|0.67||0.504|2-Sided|||||Alpha was unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.||
1706338|NCT00895583|3138553|Superiority or Other||Difference in Adjusted Means|10.02|Standard Error of the Mean|23.61||0.672|2-Sided|||||Alpha was unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.||
1706339|NCT00895583|3138554|Superiority or Other||Difference in Adjusted Means|-0.28|Standard Error of the Mean|0.25||0.265|2-Sided|||||Alpha is unadjusted.|ANCOVA||ANCOVA with treatment as a factor and baseline as a covariate.||
1706340|NCT00895583|3138555|Superiority or Other||Difference in Adjusted Means|0.0|Standard Error of the Mean|0.0||0.521|2-Sided|||||Alpha was unadjusted.|ANCOVA||||
1706341|NCT00895583|3138556|Superiority or Other|||||||0.685||||||Alpha was unadjusted.|Fisher Exact|||Off-Therapy Period, any treatment|
1706342|NCT00895583|3138556|Superiority or Other||||||<|0.001||||||Alpha was unadjusted.|Fisher Exact|||On-Therapy Period, any treatment|
1706343|NCT00895583|3138557|Superiority or Other||||||<|0.001||||||Alpha is unadjusted.|Fisher Exact||||
1706344|NCT00895583|3138558|Superiority or Other|||||||0.021||||||Alpha was unadjusted.|Fisher Exact|||Off-Therapy Period|
1706345|NCT00895583|3138558|Superiority or Other|||||||0.02||||||Alpha was unadjusted.|Fisher Exact|||On-Therapy Period|
1706346|NCT00895583|3138558|Superiority or Other|||||||1||||||Alpha was unadjusted.|Fisher Exact|||Pre-randomization|
1706347|NCT00895583|3138559|Superiority or Other||Treatment Ratio|1.77|||<|0.001|2-Sided|95.0|1.39|2.26||Alpha was unadjusted.|ANCOVA|ANCOVA model with change in the logarithmic Upr/Cr as dependent variable, treatment and logarithmic pre-randomization value as covariate.||Change from pre-randomization at Month 24; treatment ratio (SRC/TAC) in adjusted geometric mean fold-change from baseline.|
1706348|NCT00895583|3138559|Superiority or Other||Treatment Ratio|1.71|||<|0.001|2-Sided|95.0|1.38|2.11||Alpha was unadjusted.|ANCOVA|ANCOVA model with change in the logarithmic Upr/Cr as dependent variable, treatment and logarithmic pre-randomization value as covariate.||Change from pre-randomization at Month 12; treatment ratio (SRC/TAC) in adjusted geometric mean fold-change from baseline.|
1706349|NCT00895583|3138560|Superiority or Other|||||||0.723||||||Alpha was unadjusted.|Fisher Exact|||ESAs, Month 24|
1706350|NCT00895583|3138560|Superiority or Other|||||||0.086||||||Alpha was unadjusted.|Fisher Exact|||ESAs, Month 12|
1706351|NCT00895583|3138560|Superiority or Other|||||||0.26||||||Alpha was unadjusted.|Fisher Exact|||ESAs, Baseline|
1706352|NCT00895583|3138560|Superiority or Other|||||||0.802||||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Month 24|
1706353|NCT00895583|3138560|Superiority or Other|||||||0.9||||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Month 12|
1706354|NCT00895583|3138560|Superiority or Other|||||||0.033||||||Alpha was unadjusted.|Fisher Exact|||Lipid-lowering agents, Baseline|
1706355|NCT00895583|3138560|Superiority or Other|||||||0.423||||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Month 24|
1706356|NCT00895583|3138560|Superiority or Other|||||||0.566||||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Month 12|
1706357|NCT00895583|3138560|Superiority or Other|||||||0.498||||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (non-insulin), Baseline|
1706358|NCT00895583|3138560|Superiority or Other|||||||0.223||||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (insulin), Month 24|
1706359|NCT00895583|3138560|Superiority or Other|||||||1||||||Alpha was unadjusted.|Fisher Exact|||Diabetes agent (insulin), Month 12|
1706360|NCT00895583|3138560|Superiority or Other|||||||1||||||Alpha was unadjusted.|Fisher Exact|||Diabetes agents (insulin), Baseline|
1706365|NCT00895583|3138561|Superiority or Other||Difference in Adjusted Means|0.65|Standard Error of the Mean|0.13|<|0.001|2-Sided|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||Triglycerides, Month 12|
1706366|NCT00895583|3138561|Superiority or Other||Difference in Adjusted Means|0.42|Standard Error of the Mean|0.13|<|0.001|2-Sided|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||LDL-C, Month 24|
1706367|NCT00895583|3138561|Superiority or Other||Difference in Adjusted Means|0.49|Standard Error of the Mean|0.11|<|0.001|2-Sided|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||LDL-C, Month 12|
1706368|NCT00895583|3138561|Superiority or Other||Difference in Adjusted Means|-0.02|Standard Error of the Mean|0.05|<|0.735|2-Sided|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||HDL-C, Month 24|
1706369|NCT00895583|3138561|Superiority or Other||Difference in Adjusted Means|-0.01|Standard Error of the Mean|0.03|<|0.824|2-Sided|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||HDL-C, Month 12|
1706370|NCT00895583|3138561|Superiority or Other||Difference in Adjusted Mean|0.61|Standard Error of the Mean|0.14|<|0.001|2-Sided|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||TC, Month 24|
1706371|NCT00895583|3138561|Superiority or Other||Difference in Adjusted Means|0.81|Standard Error of the Mean|0.12|<|0.001|2-Sided|||||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate.||TC, Month 12|
1706372|NCT00895583|3138562|Superiority or Other|||||||1||||||Alpha was unadjusted.|Fisher Exact|||Month 24|
1706373|NCT00895583|3138562|Superiority or Other|||||||0.046||||||Alpha was unadjusted.|Fisher Exact|||Month 12|
1706374|NCT00895583|3138562|Superiority or Other|||||||0.284||||||Alpha was unadjusted.|Fisher Exact|||Baseline|
1706375|NCT00895583|3138563|Superiority or Other|||||||1||||||Alpha was unadjusted.|Fisher Exact|||Off-therapy Period|
1706376|NCT00895583|3138563|Superiority or Other|||||||1||||||Alpha was unadjusted.|Fisher Exact|||On-therapy Period|
1706377|NCT00895583|3138566|Superiority or Other|||||||0.02||||||Alpha was unadjusted.|Fisher Exact|||Month 24|
1706378|NCT00895583|3138566|Superiority or Other|||||||0.061||||||Alpha was unadjusted.|Fisher Exact|||Month 18|
1706379|NCT00895583|3138566|Superiority or Other|||||||0.067||||||Alpha was unadjusted.|Fisher Exact|||Month 12|
1706380|NCT00895583|3138566|Superiority or Other|||||||0.499||||||Alpha was unadjusted.|Fisher Exact|||Month 6|
1706381|NCT00895583|3138567|Superiority or Other|||||||0.215||||||Alpha was unadjusted.|Fisher Exact|||Post-randomization to Month 24 post-transplantation|
1706382|NCT00895583|3138567|Superiority or Other|||||||1||||||Alpha was unadjusted.|Fisher Exact|||Post-randomization to Month 12 Post-transplantation|
1706383|NCT00895583|3138568|Superiority or Other|||||||0.006||||||Alpha was unadjusted.|Fisher Exact||||
1706384|NCT00895583|3138569|Superiority or Other||LS Mean Difference|3.2|Standard Error of the Mean|5.8||0.582|2-Sided|95.0|-8.2|14.6||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 24|
1706385|NCT00895583|3138569|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|3.4||0.955|2-Sided|95.0|-6.8|6.4||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 18|
1706386|NCT00895583|3138569|Superiority or Other||LS Mean Difference|7.7|Standard Error of the Mean|3.3||0.023|2-Sided|95.0|1.1|14.3||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 12|
1706387|NCT00895583|3138569|Superiority or Other||LS Mean Difference|-3.9|Standard Error of the Mean|2.4||0.105|2-Sided|95.0|-8.6|0.8||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline serum creatinine as a covariate.||Change from randomization at Month 6|
1706388|NCT00895583|3138571|Superiority or Other||Slope difference (SRL-TAC)|-1.8||||0.131|2-Sided|95.0|-4.2|0.5|||Random coefficient model||Random coefficient model with GFR as the dependent variable and study day as the independent variable.|Slope difference (sirolimus [SRL] minus tacrolimus [TAC])|
1706389|NCT00895583|3138572|Superiority or Other||LS Mean Difference|0.7|Standard Error of the Mean|1.9||0.71|2-Sided|95.0|-3.0|4.4||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 24|
1706390|NCT00895583|3138572|Superiority or Other||LS Mean Difference|0.6|Standard Error of the Mean|1.7||0.722|2-Sided|95.0|-2.7|3.9||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 18|
1706391|NCT00895583|3138572|Superiority or Other||LS Mean Difference|-1.9|Standard Error of the Mean|1.5||0.215|2-Sided|95.0|-4.8|1.1||Alpha was unadjusted.|ANCOVA|ANCOVA with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 12|
1706392|NCT00895583|3138572|Superiority or Other||Least Squares (LS) Mean Difference|3.0|Standard Error of the Mean|1.3||0.019|2-Sided|95.0|0.5|5.5||Alpha was unadjusted.|ANCOVA|Analysis of covariance (ANCOVA) with treatment as a factor and baseline GFR as a covariate.||Change from randomization at Month 6|
1706393|NCT00895583|3138574|Superiority or Other||Odds Ratio (OR)|1.0||||1|2-Sided|95.0|0.6|1.8||Alpha was unadjusted.|Fisher Exact|||Month 24|
1706394|NCT00895583|3138574|Superiority or Other||Odds Ratio (OR)|0.8||||0.543|2-Sided|95.0|0.4|1.5||Alpha was unadjusted.|Fisher Exact|||Month 12|
1706395|NCT00895583|3138575|Superiority or Other||Odds Ratio (OR)|0.8||||0.33|2-Sided|95.0|0.4|1.3||Alpha was unadjusted.|Fisher Exact|||Month 24|
1706396|NCT00895583|3138575|Superiority or Other||Odds Ratio (OR)|0.6||||0.055|2-Sided|95.0|0.3|1.0||Alpha was unadjusted.|Fisher Exact|||Month 12|
1706397|NCT00895583|3138576|Superiority or Other||Odds Ratio (OR)|0.7||||0.298|2-Sided|95.0|0.4|1.2||Alpha was unadjusted.|Fisher Exact|||Month 24|
1706398|NCT00895583|3138576|Superiority or Other||Odds Ratio (OR)|0.8||||0.524|2-Sided|95.0|0.5|1.4||Alpha was unadjusted.|Fisher Exact|||Month 12|
1706399|NCT00895583|3138577|Superiority or Other||Odds Ratio (OR)|0.8||||0.422|2-Sided|95.0|0.5|1.4||Alpha was unadjusted.|Fisher Exact||||
1706402|NCT00894803|3138647|Superiority or Other||Odds Ratio (OR)|1.98||||0.22|2-Sided|95.0|0.67|5.88|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706403|NCT00894803|3138647|Superiority or Other||Odds Ratio (OR)|2.44||||0.07|2-Sided|95.0|0.9|6.64|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706404|NCT00894803|3138648|Superiority or Other||Odds Ratio (OR)|1.11||||0.82|2-Sided|95.0|0.46|2.67|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706405|NCT00894803|3138649|Superiority or Other||Odds Ratio (OR)|1.39||||0.55|2-Sided|95.0|0.47|4.07|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706406|NCT00894803|3138650|Superiority or Other||Odds Ratio (OR)|1.68||||0.31|2-Sided|95.0|0.61|4.99|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706407|NCT00894803|3138651|Superiority or Other||Odds Ratio (OR)|1.19||||0.73|2-Sided|95.0|0.44|3.24|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706408|NCT00894803|3138651|Superiority or Other||Odds Ratio (OR)|1.59||||0.3|2-Sided|95.0|0.65|3.88|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706409|NCT00894803|3138652|Superiority or Other||Odds Ratio (OR)|1.1||||0.85|2-Sided|95.0|0.4|3.02|||Regression, Logistic|adjusting for age, baseline NIHSS and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706410|NCT00894803|3138652|Superiority or Other||Odds Ratio (OR)|1.52||||0.35|2-Sided|95.0|0.63|3.67|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706411|NCT00894803|3138653|Superiority or Other||Odds Ratio (OR)|0.92||||0.99999|2-Sided|95.0|0.26|4.18|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706412|NCT00894803|3138654|Superiority or Other||Odds Ratio (OR)|1.29||||0.78|2-Sided|95.0|0.38|5.76|||Regression, Logistic|Exact methods used due t number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706413|NCT00894803|3138655|Superiority or Other||Odds Ratio (OR)|0.99||||0.99999|2-Sided|95.0|0.24|5.92|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706414|NCT00894803|3138656|Superiority or Other||Odds Ratio (OR)|0.99||||0.99999|2-Sided|95.0|0.24|5.92|||Regression, Logistic|Exact method used due to small number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706415|NCT00894803|3138657|Superiority or Other||Odds Ratio (OR)|1.38||||0.76||95.0|0.35|8.02|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706416|NCT00894803|3138658|Superiority or Other||Odds Ratio (OR)|0.15||||0.053|2-Sided|95.0|0.01|1.4|||Regression, Logistic|Exact method used due to number of responses|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706417|NCT00894803|3138660|Superiority or Other||Odds Ratio (OR)|1.37||||0.53|2-Sided|95.0|0.51|3.71|||Regression, Logistic|adjusting for age, baseline NIHSS score and time to IV rt-PA|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706418|NCT00894803|3138660|Superiority or Other||Odds Ratio (OR)|1.74||||0.23|2-Sided|95.0|0.7|4.31|||Regression, Logistic||Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706419|NCT00894803|3138661|Superiority or Other||Odds Ratio (OR)|0.15||||0.053|2-Sided|95.0|0.01|1.4|||Regression, Logistic|an exact logistic regression was used due to the number of events|Arm 2 (rt-PA and Eptifibitide) represents the numerator, Arm 1 (rt-PA only) the denominator||
1706420|NCT00894738|3138671|Superiority or Other||||||<|0.0001||||||The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.|ANCOVA|||The statistical analysis consisted of treatment group as a 2-level factor variable and DEXA total percent fat as a covariate. An interaction term between treatment group and DEXA total percent fat was also generated. Hepatic triglyceride content was the dependent variable. DEXA total percent fat was found to be significant while treatment group and the interaction between treatment group and DEXA total percent fat were not significant.|
1706421|NCT00894738|3138672|Superiority or Other|||||||0.49||||||The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.|ANCOVA|||The null hypothesis is that mean DEXA total percent fat is similar between the two groups of interest. The primary statistical model consisted of treatment group as a 2-level factor (AP-Treated Vs Non-AP Treated) and DEXA total percent fat as a covariate. Carotid intima-media thickness (CIMT) was the dependent variable.|
1706422|NCT00894699|3138673|Superiority or Other||||||<|0.001|||||||ANOVA||||
1706423|NCT00894699|3138673|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1706424|NCT00894556|3138696|Superiority or Other||||||<|0.001|||||||Generalized Linear Mixed Model (GLIMMIX)|An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.|||
1706425|NCT00894556|3138697|Superiority or Other||||||<|0.001|||||||Generalized Linear Mixed Model (GLIMMIX)|An unstructured covariance matrix was used to model the correlation among repeated measurements within patient.|||
1706426|NCT00894543|3138698|Superiority or Other|||||||0.001|||||||Regression, Linear||||
1706427|NCT00894543|3138699|Superiority or Other||||||<|0.001||||||P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).|Regression, Linear|Natural log transformations applied to hot flash frequencies for modeling assumptions.||Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.|
1708389|NCT00858208|3143286|Superiority or Other|||||||0.2749|||||||paired t-test|||Change from baseline at Week 96|
1706428|NCT00894543|3138703|Superiority or Other||||||<|0.001||||||P values from comparison of Escitalopram vs placebo in a linear model of the outcome as a function of intervention group and adjusted for race, clinical center, baseline outcome, and visit (week 4 or week 8).|Regression, Linear|Natural log transformations applied to hot flash frequencies for modeling assumptions.||Based on data from the Herbal Alternatives for Menopause (HALT) study, MsFLASH estimated that 90 women in each treatment group provide 90% power to detect a difference between drug and placebo with a 2-sided alpha of 0.025 to account for two primary outcomes of hot flash frequency and severity.|
1706429|NCT00894322|3138732|Superiority or Other||LS Mean Difference|-40.4|Standard Error of the Mean|12.8||0.0035|2-Sided|95.0|-66.5|-14.3|||ANOVA|treatment group and HbA1c stratum at screening were factors.|||
1706430|NCT00894322|3138733|Superiority or Other||LS Mean Difference|-1.03|Standard Error of the Mean|0.835||0.2285|2-Sided|95.0|-2.73|0.68|||ANOVA|treatment group and HbA1c stratum at screening were factors.||Least square mean (LS) mean, 95% confidence interval (CI) and p-value calculated for the changes in weight from baseline in participants in cohort 2 treated with exenatide with placebo as reference group.|
1706431|NCT00894322|3138734|Superiority or Other|||||||0.0033|||||||Cochran-Mantel-Haenszel|Adjusted for HbA1c strata at screening.|||
1706432|NCT00894322|3138735|Superiority or Other||Mean Difference (Final Values)|-0.95|Standard Error of the Mean|0.269||0.0013|2-Sided|95.0|-1.5|-0.4||Treatment group and HbA1c stratum at screening were factors. Placebo was reference group.|ANOVA||||
1706433|NCT00893789|3138805|Superiority or Other|||||||0.4401|||||||Pearson's chi-squared||||
1706434|NCT00893789|3138805|Superiority or Other|||||||0.2359|||||||Pearson's chi-squared||||
1706435|NCT00893789|3138805|Superiority or Other|||||||0.7884|||||||Pearson's chi-squared||||
1706436|NCT00893789|3138806|Superiority or Other|||||||0.001||||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||P-value for “Change from Baseline at Endpoint.”|
1706437|NCT00893789|3138806|Superiority or Other|||||||0.0514||||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||P-value for “Change from Baseline at Endpoint.”|
1706438|NCT00893789|3138806|Superiority or Other|||||||0.8336||||||The analyses performed were not done in accordance to the study protocol as the study was terminated early and therefore the analyses done were underpowered, no adjustments for multiple comparisons (or step-down analysis rules) were applied.|ANCOVA|||P-value for “Change from Baseline at Endpoint.”|
1706439|NCT00893763|3138810|Superiority or Other|||||||0.8656|||||||Regression, Logistic|||A logistic regression analysis was performed using the binary response variable of colonization or no colonization and dependent variables for group, length of intubation, and group-by-length-of-intubation interaction. The probability of a type 1 error ( a ) was set to 0.05.|
1706440|NCT00893763|3138810|Superiority or Other|||||||0.1763|||||||mixed effects linear model|||We compared groups in a single analytical model using a mixed effects linear model with CPIS as the response variable. For this model, group (CHX, control), day, group by day interaction, APACHE III score and hospital (VCU, USF) were modeled as fixed effects and subject was modeled as a random effect.|
1706441|NCT00893152|3138829|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1706442|NCT00892957|3138855|Superiority or Other|||||||0.545|||||||Likelihood ratio chi-square test||||
1706443|NCT00892957|3138856|Superiority or Other|||||||0.38|||||||Likelihood ratio chi-square test||||
1706444|NCT00892957|3138858|Superiority or Other|||||||0.158|||||||Likelihood ratio chi-square test||||
1706445|NCT00892957|3138859|Superiority or Other|||||||0.012|||||||Likelihood ratio chi-square test||||
1706446|NCT00892957|3138860|Superiority or Other|||||||0.001|||||||Likelihood ratio chi-square test||||
1706447|NCT00892957|3138861|Superiority or Other||||||<|0.0001|||||||Likelihood ratio chi-square test||||
1706448|NCT00892775|3138871|Non-Inferiority|Non-inferiority with respect to seroconversion rates for varicella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.|Difference in percentage|4.69|||||2-Sided|95.0|0.72|10.34|||||||
1706449|NCT00892775|3138871|Non-Inferiority|Non-inferiority with respect to seroconversion rates for rubella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.|Difference in percentage|-0.32|||||2-Sided|95.0|-1.78|2.08|||||||
1706450|NCT00892775|3138871|Non-Inferiority|Non-inferiority with respect to seroconversion rates for mumps 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.|Difference in percentage|-0.74|||||2-Sided|95.0|-6.14|5.58|||||||
1706451|NCT00892775|3138871|Non-Inferiority|Non-inferiority with respect to seroconversion rates for measles 42-56 days after vaccination was concluded if the lower limit of the 95% confidence interval around the difference in seroconversion rates between groups would be [–10%] or higher.|Difference in percentage|-0.64|||||2-Sided|95.0|-2.29|1.76|||||||
1706452|NCT00892723|3138872|Superiority or Other|||||||0.45||||||For this early phase study, no adjustments were used.|Wilcoxon (signed rank)|For this early phase study, no adjustments were used.|||
1706453|NCT00892723|3138872|Superiority or Other|||||||0.16|||||||Wilcoxon (signed rank)|For this early phase study, no adjustments were used.|||
1706454|NCT00892723|3138872|Superiority or Other|||||||0.079|||||||Wilcoxon (signed rank)|For this early phase study, no adjustments were used.|||
1706455|NCT00892723|3138872|Superiority or Other|||||||0.45||||||For this early phase study, no adjustments were used.|Wilcoxon (signed rank)||||
1706456|NCT00892723|3138872|Superiority or Other|||||||0.74||||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)||||
1706457|NCT00892723|3138872|Superiority or Other|||||||0.16|||||||Wilcoxon (signed rank)|For this early phase study, no adjustment was used.|||
1706458|NCT00892723|3138873|Superiority or Other|||||||0.9|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1709134|NCT00852995|3144526|Superiority or Other|||||||0.013||||||Week 11|Cochran-Mantel-Haenszel||||
1706459|NCT00892723|3138873|Superiority or Other|||||||0.21|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706460|NCT00892723|3138873|Superiority or Other|||||||0.65|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706461|NCT00892723|3138873|Superiority or Other|||||||0.33|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706462|NCT00892723|3138873|Superiority or Other|||||||0.32|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706463|NCT00892723|3138873|Superiority or Other|||||||0.56|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706464|NCT00892723|3138873|Superiority or Other|||||||0.68|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706465|NCT00892723|3138873|Superiority or Other|||||||0.14|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706466|NCT00892723|3138873|Superiority or Other|||||||0.94|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706467|NCT00892723|3138873|Superiority or Other|||||||0.73|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706468|NCT00892723|3138874|Superiority or Other|||||||0.71|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706469|NCT00892723|3138874|Superiority or Other|||||||0.23|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706470|NCT00892723|3138874|Superiority or Other|||||||0.82|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706471|NCT00892723|3138874|Superiority or Other|||||||0.23|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706472|NCT00892723|3138875|Superiority or Other|||||||0.91|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706473|NCT00892723|3138875|Superiority or Other|||||||0.11|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706474|NCT00892723|3138875|Superiority or Other|||||||0.86|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706475|NCT00892723|3138875|Superiority or Other|||||||0.87|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1706476|NCT00892606|3138884|Superiority|||||||0.0146|||||||ANOVA||||
1706477|NCT00892606|3138885|Superiority|||||||0.004|||||||ANOVA||||
1706478|NCT00892606|3138886|Superiority|||||||0.0072|||||||ANOVA||||
1706479|NCT00892437|3138887|Superiority or Other||Difference in LSM|47.0||||0.29|2-Sided|95.0|-41.0|134.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.||
1706480|NCT00892437|3138888|Superiority or Other||Difference in LSM|10.0||||0.78|2-Sided|95.0|-63.0|84.0||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.||
1706481|NCT00892437|3138889|Superiority or Other||Difference in LSM|-0.03||||0.82|2-Sided|95.0|-0.3|0.23||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in LSM and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.||
1706482|NCT00892437|3138890|Superiority or Other||Difference in least squares mean (LSM)|-0.02||||0.87|2-Sided|95.0|-0.25|0.22||P-values were obtained from an ANOVA model including baseline HIV-1 RNA category in the model.|ANOVA||The difference in least squares mean (LSM) and its 95% CI were computed using ANOVA model, including baseline HIV-1 RNA category in the model.||
1706483|NCT00892437|3138891|Non-Inferiority or Equivalence|The null hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than the response rate in ATV+RTV+FTC/TDF group; the alternative hypothesis was that the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group.|Difference in percentages|-8.3|||||2-Sided|95.0|-25.9|9.4|||||Difference in percentages of success and its 95% CI were calculated based on baseline HIV-1 RNA stratum-adjusted MH proportion.||
1706484|NCT00892437|3138892|Non-Inferiority or Equivalence|Null hypothesis: the response rate in the ATV+COBI+FTC/TDF group was at least 12% worse than in the ATV+RTV+FTC/TDF group; alternative hypothesis: the response rate in the ATV+COBI+FTC/TDF group was less than 12% worse than that in the ATV+RTV+FTC/TDF group. ATV+COBI+FTC/TDF was noninferior if the lower bound of the 2-sided 95% confidence interval (CI) of the baseline HIV-1 RNA stratum-weighted difference (COBI group – RTV group) in the response rate at Week 24 was greater than −12%.|Difference in percentages|-7.4|||||2-Sided|95.0|-24.6|9.9|||||Difference in percentages of success and its 95% confidence interval (CI) were calculated based on baseline HIV-1 RNA stratum-adjusted Mantel-Haenszel (MH) proportion.|A total planned sample size of 75 subjects had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA < 50 copies/mL at Week 24 if a response rate of 84% for both arms and a noninferiority margin of 0.12 were assumed.|
1706485|NCT00892177|3138896|Superiority|||||||0.6325|||||||Fisher Exact||||
1706486|NCT00892177|3138897|Superiority||Mean Difference (Final Values)|-0.223||||0.96|2-Sided||||||Mixed Models Analysis||The estimate is the net difference between Arm A and Arm B total score using information from all cycles. A negative value means that Arm A has a lower quality of life and a positive value means Arm A has a higher reported quality of life.||
1706487|NCT00892177|3138898|Superiority or Other (legacy)||Hazard Ratio (HR)|1.14||||0.52|2-Sided|95.0|0.76|1.7|||Kaplan Meier||||
1706488|NCT00892177|3138899|Superiority or Other (legacy)||Hazard Ratio (HR)|0.92||||0.7|2-Sided|95.0|0.61|1.4|||Kaplan Meier||||
1706489|NCT00892177|3138901|Superiority or Other (legacy)||Difference|0.1||||0.22|2-Sided|95.0|-0.052|0.262|||Chi-squared, Corrected||Difference in proportion||
1706490|NCT00892177|3138902|Superiority or Other (legacy)||Maximum Tolerated Dose (mg)|100.0|||||2-Sided||||||||||
1706491|NCT00891995|3138934|Superiority or Other|||||||0.4||||||One-sided p-value|ANCOVA|Adjusted for baseline A1c, age, gender and Diabetic ketoacidosis|||
1706492|NCT00891995|3138937|Superiority or Other|||||||0.49||||||One-sided p-value.|ANCOVA|Adjusted for baseline C-peptide AUC, age, gender and diabetic ketoacidosis.|||
1709135|NCT00852995|3144526|Superiority or Other|||||||0.044||||||Week 10|Cochran-Mantel-Haenszel||||
1706493|NCT00891930|3138968|Superiority or Other|||||||0.052||||||Exact test for a single proportion was performed with a null hypothesis of 1%.|Exact test||||
1706494|NCT00891878|3138977|Superiority|||||||0.45|||||||Fisher Exact||||
1706495|NCT00891878|3138978|Superiority|||||||0.43|||||||Log Rank||||
1706496|NCT00891462|3139009|Superiority or Other||Least Squares Mean Difference|0.124|||<|0.0001|2-Sided|95.0|0.08|0.16|||ANCOVA||||
1706497|NCT00891462|3139009|Superiority or Other||Least Squares Mean Difference|0.086|||<|0.0001|2-Sided|95.0|0.05|0.13|||ANCOVA||||
1706498|NCT00891436|3139010|Non-Inferiority or Equivalence|t-test showed no different between the 2 groups.|Mean Difference (Final Values)|2.0|Standard Error of the Mean|0.5|>|0.1||95.0|||||t-test, 2 sided||||
1706499|NCT00891436|3139010|Superiority or Other||Mean Difference (Final Values)|2.0|Standard Error of the Mean|0.5|>|0.1||95.0|||||t-test, 2 sided|||paired t-test was used for the data analysis|
1706500|NCT00891293|3139029|Superiority or Other||Median Difference (Net)|3.3|Standard Deviation|29.01||0.9999||95.0|-2.8|9.4|||ANOVA||Difference Between Percent Change from LOV111859/OM5 Baseline to LOV111860/OM5X End-of-Treatment and Percent Change from LOV111859/OM5 Baseline to LOV111821/OM5XX End-of-Treatment|For the MITT analysis, the method of last observation carried forward (LOCF) was applied. The LOCF is the value of a previous non-baseline visit (post-enrollment) carried forward to the subsequent visit, if missing.|
1706501|NCT00891202|3139043|Superiority or Other||Least Squares Mean Difference|-30.03|Standard Error of the Mean|3.35|<|0.0001|2-Sided|95.0|-36.82|-23.24|||ANCOVA|||Analysis was performed using analysis of covariance (ANCOVA) model fitted with treatment and baseline spleen severity (low spleen severity: spleen volume less than or equal to [<=] 20 multiples of normal spleen volume, high spleen severity: spleen volume greater than [>] 20 multiples of normal spleen volume).|
1706502|NCT00890981|3139107|Superiority or Other||Ratio of Denosumab to Placebo|1.2||||0.0079||95.0|1.0|1.3|||ANCOVA|||ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.|
1706503|NCT00890981|3139108|Superiority or Other||Ratio of Denosumab to Placebo|1.1||||0.0591||95.0|1.0|1.3|||ANCOVA|||ANCOVA based on the log transformed actual values with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.|
1706504|NCT00890981|3139109|Superiority or Other||Mean Difference (Final Values)|2.1||||0.0035||95.0|0.7|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.|
1706505|NCT00890981|3139110|Superiority or Other||Mean Difference (Final Values)|1.6||||0.0911||95.0|-0.3|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.|
1706506|NCT00890981|3139111|Superiority or Other||Mean Difference (Final Values)|2.1||||0.0184||95.0|0.4|3.8|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.|
1706507|NCT00890981|3139112|Superiority or Other||Mean Difference (Final Values)|3.9||||0.0067||95.0|1.1|6.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.|
1706508|NCT00890981|3139113|Superiority or Other||Mean Difference (Final Values)|0.4||||0.2897||95.0|-0.4|1.2|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.|
1706509|NCT00890981|3139114|Superiority or Other||Mean Difference (Final Values)|2.6||||0.0032||95.0|0.9|4.3|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.|
1706510|NCT00890981|3139115|Superiority or Other||Mean Difference (Final Values)|1.8||||0.0594||95.0|-0.1|3.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.|
1706511|NCT00890981|3139116|Superiority or Other||Mean Difference (Final Values)|0.7||||0.656||95.0|-2.5|4.0|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model includes linear, quadratic and cubic time terms but without treatment-by-time interaction.|
1706512|NCT00890981|3139117|Superiority or Other||Mean Difference (Final Values)|0.9||||0.0228||95.0|0.1|1.7|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms but without treatment-by-time interaction.|
1706542|NCT00887978|3139356|Superiority or Other||Hodges-Lehmann (H-L) estimate|0.0||||0.3|2-Sided|95.0|0.0|1.0|||Wilcoxon rank sum test||||
1706513|NCT00890981|3139118|Superiority or Other||Mean Difference (Final Values)|1.5||||0.1648||95.0|-0.6|3.5|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear time term but without treatment-by-time interaction.|
1706514|NCT00890981|3139119|Superiority or Other||Mean Difference (Final Values)|3.7||||0.0766||95.0|-0.4|7.8|||ANCOVA|||An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms with treatment-by-time interaction|
1706515|NCT00890825|3139130|Superiority or Other||Hazard Ratio (HR)|0.54||||0.0158|2-Sided|80.0|0.37|0.78||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.|Log Rank|Confidence interval (CI) used Greenwood's formula for the standard error of a survival estimate|A hazard ratio (HR) <1 favours AZD6244 75 mg bd+Docetaxel||
1706516|NCT00890825|3139131|Superiority or Other||Mean Difference (Final Values)|-26.0||||0.004|2-Sided|80.0|-38.34|-13.7||One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.|ANCOVA|LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status|(AZD6244 + Docetaxel) - (Placebo + Docetaxel)||
1706517|NCT00890825|3139132|Superiority or Other||LSmeans difference|-17.03||||0.004|2-Sided|80.0|-25.2|-8.86||One-sided p-value. The p-value is associated with the point estimate comparing AZD6244 + Docetaxel vs Placebo + Docetaxel on the outcome measure.|ANCOVA|LS means were adjusted for baseline tumour size, time from baseline scan to randomisation, WHO PS, gender, histology, and smoking status.|(AZD6244 + Docetaxel) - (Placebo + Docetaxel)||
1706518|NCT00890825|3139134|Superiority or Other||Odds Ratio (OR)|37.2|||<|0.0001|2-Sided|95.0|23.0|53.0||Two-sided P-value|Fisher Exact||||
1706519|NCT00890825|3139135|Superiority or Other||Hazard Ratio (HR)|0.58||||0.0138|2-Sided|80.0|0.42|0.79||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure.|Regression, Cox|The model allowed for the effect of treatment and included terms for WHO PS, gender, histology, and smoking status.|A Hazard Ratio (HR) < 1 favoured AZD6244 + Docetaxel||
1706520|NCT00890825|3139136|Superiority or Other||Hazard Ratio (HR)|0.8||||0.2069|2-Sided|80.0|0.56|1.14||One-sided p-value. The p-value is associated with the point estimate (e.g. HR comparing AZD6244 + Docetaxel vs Placebo + Docetaxel) on the outcome measure - Overall survival.|Regression, Cox|Analysis adjusted for the following covariates; WHO PS, gender, histology and smoking status|A Hazard Ratio less than 1 favoured AZD6244 + Docetaxel||
1706521|NCT00889707|3139214|Superiority or Other|||||||0.047||||||ANCOVA model with terms for treatment group, baseline total IPSS, baseline prostate volume, and baseline Qmax.|ANCOVA|Model with terms for treatment group, baseline total IPSS, baseline prostate volume, and baseline Qmax.|||
1706522|NCT00889707|3139215|Superiority or Other|||||||0.04||||||Test of superiority computed using an ANCOVA model with terms for treatment group, baseline total IPSS, and baseline prostate volume. Tested for 2-sided 0.05 level of statistical significance.|ANCOVA|ANCOVA model with terms for treatment group, baseline total IPSS, and baseline prostate volume.|||
1706523|NCT00889603|3139228|Superiority or Other||Mean Difference (Final Values)|1.97|||||2-Sided|95.0|1.69|2.25|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 24 from a repeated-measures mixed model including terms for baseline MMSE and Week.||
1706524|NCT00889603|3139228|Superiority or Other||Mean Difference (Final Values)|1.56|||||2-Sided|95.0|1.32|1.8|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 16 from a repeated-measures mixed model including terms for baseline MMSE and Week.||
1706525|NCT00889603|3139228|Superiority or Other||Mean Difference (Final Values)|0.92|||||2-Sided|95.0|0.75|1.08|||||LS Mean and 95% CI for change from baseline in MMSE Total to Week 8 from repeated-measures mixed model including terms for baseline MMSE and Week.||
1706526|NCT00889603|3139229|Superiority or Other||Mean Difference (Net)|1.92|||||2-Sided|95.0|1.65|2.2|||||Change from baseline in MMSE at LOCF analyzed using single-sample t-test; a 95% confidence interval (CI) was calculated for mean change at LOCF.||
1706527|NCT00889005|3139281|Superiority or Other|||||||0.927|||||||ANOVA||||
1706528|NCT00888940|3139286|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1706529|NCT00888849|3139287|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.21||0.7774|2-Sided|95.0|-0.2|0.6||Adjusted for multiplicity via Bonferroni-Holm procedure|ANOVA||||
1706530|NCT00888849|3139288|Superiority or Other||Mean Difference (Final Values)|2.9|Standard Error of the Mean|0.8||0.0008|2-Sided|95.0|1.4|4.5||Adjusted for multiplicity via Bonferroni-Holm procedure|ANOVA||||
1706531|NCT00888849|3139289|Superiority or Other||Mean Difference (Final Values)|-4.3|Standard Error of the Mean|7.69||0.7774|2-Sided|95.0|-19.4|10.9||Adjusted for multiplicity via the Bonferroni-Holm method|ANOVA||||
1706532|NCT00888459|3139308|Superiority or Other|||||||0.432|||||||Chi-squared||||
1706533|NCT00888238|3139330|Superiority or Other||Least Squares Mean|1.3|||<|0.001||90.0|1.08|1.52|||ANOVA||||
1706534|NCT00888238|3139331|Superiority or Other||Least Squares Mean|1.7|||<|0.001||90.0|1.47|1.93|||ANOVA||||
1706535|NCT00887978|3139346|Superiority or Other||Hodges-Lehmann Estimate|-2.0||||0.84||95.0|-25.0|22.0|||ANCOVA||||
1706536|NCT00887978|3139347|Superiority or Other||Hodges-Lehmann Estimate|3.0||||0.99|2-Sided|95.0|-23.0|28.0|||ANCOVA||||
1706537|NCT00887978|3139348|Superiority or Other||Hodges-Lehmann Estimate|10.0||||0.22|2-Sided|95.0|-10.0|31.0|||ANCOVA||||
1706538|NCT00887978|3139349|Superiority or Other||Hodges-Lehmann Estimate|28.0||||0.059|2-Sided|95.0|1.0|59.0|||ANCOVA||||
1706539|NCT00887978|3139350|Superiority or Other||Hodges-Lehman Estimate|4.0||||0.674|2-Sided|95.0|-16.0|24.0|||ANCOVA||||
1706540|NCT00887978|3139352|Superiority or Other||Hodges-Lehmann Estimate|15.0||||0.054|2-Sided|95.0|-1.0|29.0|||ANCOVA||||
1706541|NCT00887978|3139353|Superiority or Other||Hodges-Lehman Estimate|14.0||||0.058|2-Sided|95.0|0.0|28.0|||ANCOVA||||
1706543|NCT00887978|3139358|Superiority or Other||Hodges-Lehmann (H-L) estimate|0.0||||0.43|2-Sided|95.0|0.0|0.0||Imputation strategies were implemented for the 26 UT-15C subjects and 17 placebo subjects without values reported at Week 16.|Wilcoxon rank sum test||||
1706544|NCT00887978|3139359|Superiority or Other||Hodges-Lehmann (H-L) Estimate|0.0||||0.22|2-Sided|95.0|-1.0|0.0|||Wilcoxon rank sum test||||
1706545|NCT00887978|3139360|Superiority or Other|||||||1|||||||Fisher Exact||||
1706546|NCT00887978|3139361|Superiority or Other||Hodges-Lehmann (H-L)|10.0||||0.089|2-Sided|95.0|-2.0|22.0|||non-parametric ANCOVA|||Using an allocation ratio of 1:1 between UT-15C SR and placebo, a fixed sample size of approximately 266 subjects would provide at least 90% power at a significance level of 0.05 (two-sided hypothesis) to detect a 30 meter between-treatment difference in the change from Baseline in distance traversed during the 6-Minute Walk, assuming a standard deviation of 75 meters. A total sample size of approximately 300 subjects was determined to account for discontinuations during the enrollment period.|
1706547|NCT00887822|3139402|Superiority or Other||Difference in Disease Control Rates|0.45||||0.9426|2-Sided|95.0|-12.4|13.3|||Chi-squared||Approximate 95% CI for difference of two rates using Hauck-Anderson method||
1706548|NCT00887822|3139403|Superiority or Other||Hazard Ratio (HR)|0.53||||0.0462|2-Sided|95.0|0.29|1.0|||Log Rank|The difference in distribution of response between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.||
1706549|NCT00887822|3139404|Superiority or Other||Difference in Response Rates|7.02||||0.348|2-Sided|95.0|-8.3|22.4|||Chi-squared||Approximate 95% CI for difference of two rates using Hauck-Anderson method||
1706550|NCT00887822|3139405|Superiority or Other||Hazard Ratio (HR)|0.97||||0.8589|2-Sided|95.0|0.67|1.41|||Log Rank|The difference in distribution of disease progression between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.||
1706551|NCT00887822|3139407|Superiority or Other||Hazard Ratio (HR)|0.84||||0.3685|2-Sided|95.0|0.58|1.22|||Log Rank|The difference in distribution of progression-free survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.||
1706552|NCT00887822|3139409|Superiority or Other||Hazard Ratio (HR)|0.89||||0.4709|2-Sided|95.0|0.66|1.21|||Log Rank|The difference in distribution of progression-free survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox's proportional hazards model.||
1706553|NCT00887822|3139411|Superiority or Other||Hazard Ratio (HR)|1.03||||0.8636|2-Sided|95.0|0.75|1.41|||Log Rank|The difference in distribution of survival between the two treatment arms was tested with a two-sided unstratified log-rank test.|The hazard ratio between the two treatment arms was estimated with a univariate Cox’s proportional hazards model.||
1706554|NCT00887549|3139474|Superiority or Other||Hazard Ratio (HR)|1.015|||<|0.0001|2-Sided|95.0|1.008|1.021|||Regression, Cox|The Cox model, based upon participant level data, included PFS as dependent variable and TS score in the nucleus as independent variable.|||
1706555|NCT00887471|3139521|Superiority or Other|||||||1|||||||Fisher Exact|||The relationship of surgical group with postoperative AHI ≤ 5 was evaluated by exact conditional logistic regression, predicting AHI ≤ 5 from surgical group with subject pairs as strata.|
1706556|NCT00887471|3139522|Superiority or Other|||||||0.022||||||P value for the variances. The a priori threshold for statistical significance was P < .05.|Mixed Models Analysis|||A mixed linear model was constructed as described above. Variance was estimated separately for each group.|
1706557|NCT00887471|3139522|Superiority or Other|||||||0.59||||||A priori threshold for statistical significance was P<.05.|Mixed Models Analysis|||The relationship of surgical group with AHI change was evaluated by constructing a mixed linear model (MLM). The dependent variable was the logarithm of the ratio of postoperative AHI score to preoperative AHI score; this transformation was chosen in order to minimize skew of model residuals. Surgical group was introduced as a fixed factor; subject pairs constituted levels of a random blocking) factor.|
1706558|NCT00887354|3139531|Superiority or Other (legacy)||LS Mean|0.04|||<|0.0001|2-Sided|95.0|0.025|0.055|||Mixed Models Analysis||||
1706559|NCT00887341|3139536|Superiority or Other|||||||0.937|||||||Chi-squared|||Final Visit|
1706560|NCT00887341|3139536|Superiority or Other|||||||0.6|||||||Chi-squared|||Week 20|
1706561|NCT00887341|3139536|Superiority or Other|||||||0.184|||||||Chi-squared|||Week 16|
1706562|NCT00887341|3139536|Superiority or Other|||||||0.587|||||||Chi-squared|||Week 12|
1706563|NCT00887341|3139536|Superiority or Other|||||||0.97|||||||Chi-squared|||Week 8|
1706564|NCT00887341|3139537|Superiority or Other|||||||0.516|||||||Chi-squared|||Final Visit|
1706565|NCT00887341|3139537|Superiority or Other|||||||0.69|||||||Chi-squared|||Week 20|
1706566|NCT00887341|3139537|Superiority or Other|||||||0.68|||||||Chi-squared|||Week 16|
1706567|NCT00887341|3139537|Superiority or Other|||||||0.482|||||||Chi-squared|||Week 12|
1706568|NCT00887341|3139537|Superiority or Other|||||||0.786|||||||Chi-squared|||Week 8|
1706569|NCT00887341|3139537|Superiority or Other|||||||0.327|||||||Chi-squared|||Week 4|
1706570|NCT00887341|3139538|Superiority or Other|||||||0.504|||||||Chi-squared|||Final visit|
1706571|NCT00887341|3139538|Superiority or Other|||||||0.11|||||||Chi-squared|||Week 20|
1706572|NCT00887341|3139538|Superiority or Other|||||||0.509|||||||Chi-squared|||Week 16|
1706573|NCT00887341|3139538|Superiority or Other|||||||0.304|||||||Chi-squared|||Week 12|
1706574|NCT00887341|3139538|Superiority or Other|||||||0.387|||||||Chi-squared|||Week 8|
1706575|NCT00887341|3139538|Superiority or Other|||||||0.377|||||||Chi-squared|||Week 4|
1706576|NCT00887341|3139539|Superiority or Other|||||||0.451|||||||Chi-squared|||Final visit|
1706577|NCT00887341|3139539|Superiority or Other|||||||0.017|||||||Chi-squared|||Week 20|
1706578|NCT00887341|3139539|Superiority or Other|||||||0.339|||||||Chi-squared|||Week 16|
1706579|NCT00887341|3139539|Superiority or Other|||||||0.367|||||||Chi-squared|||Week 12|
1706583|NCT00887224|3139561|Superiority or Other||Mean Difference (Final Values)|7.62|||<|0.001|2-Sided|95.0|3.14|12.1||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Activity Impairment|
1706584|NCT00887224|3139561|Superiority or Other||Mean Difference (Final Values)|7.57|||<|0.001|2-Sided|95.0|3.33|11.8||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Activity Impairment|
1706585|NCT00887224|3139561|Superiority or Other||Mean Difference (Final Values)|8.48|||<|0.0187|2-Sided|95.0|1.43|15.53||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Work Productivity Loss|
1706586|NCT00887224|3139561|Superiority or Other||Mean Difference (Final Values)|7.48|||<|0.0402|2-Sided|95.0|0.34|14.61||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Work Productivity Loss|
1706587|NCT00887224|3139561|Superiority or Other||Mean Difference (Final Values)|8.24|||<|0.0129|2-Sided|95.0|1.77|14.71||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Presenteeism|
1706588|NCT00887224|3139561|Superiority or Other||Mean Difference (Final Values)|6.91|||<|0.0414|2-Sided|95.0|0.27|13.55||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Presenteeism|
1706589|NCT00887224|3139561|Superiority or Other||Mean Difference (Final Values)|-0.33|||<|0.9059|2-Sided|95.0|-5.91|5.24||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26 Absenteeism|
1706590|NCT00887224|3139561|Superiority or Other||Mean Difference (Final Values)|1.02|||<|0.6772|2-Sided|95.0|-3.82|5.87||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14 Absenteeism|
1706591|NCT00887224|3139562|Superiority or Other||Mean Difference (Final Values)|-2.32|||<|0.001|2-Sided|95.0|-3.29|-1.34||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26|
1706592|NCT00887224|3139562|Superiority or Other||Mean Difference (Final Values)|-2.14|||<|0.001|2-Sided|95.0|-3.03|-1.24||"P-value obtained from mixed model: change from baseline = baseline + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14|
1706593|NCT00887224|3139563|Superiority or Other||Adjusted odds ratio|2.85|||<|0.0001|2-Sided|95.0|1.93|4.2||Obtained from logistic regression analysis using Remission (Yes/No) at each time point as a response variable; logistic model with treatment and sites as factors and baseline HAM-D17 total score as covariate.|Regression, Logistic|||Wald 95% CI for adjusted odds ratio.|
1706594|NCT00887224|3139564|Superiority or Other||Mean Difference (Final Values)|1.27|||<|0.001|2-Sided|95.0|0.75|1.79||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26|
1706595|NCT00887224|3139564|Superiority or Other||Mean Difference (Final Values)|1.23|||<|0.001|2-Sided|95.0|0.7|1.76||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22|
1706596|NCT00887224|3139564|Superiority or Other||Mean Difference (Final Values)|1.3|||<|0.001|2-Sided|95.0|0.76|1.83||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18|
1706597|NCT00887224|3139564|Superiority or Other||Mean Difference (Final Values)|1.12|||<|0.001|2-Sided|95.0|0.66|1.58||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14|
1706598|NCT00887224|3139564|Superiority or Other||Mean Difference (Final Values)|1.08|||<|0.001|2-Sided|95.0|0.58|1.58||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10|
1706599|NCT00887224|3139564|Superiority or Other||Mean Difference (Final Values)|0.88|||<|0.001|2-Sided|95.0|0.43|1.32||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6|
1706600|NCT00887224|3139564|Superiority or Other||Mean Difference (Final Values)|0.89|||<|0.001|2-Sided|95.0|0.49|1.28||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4|
1706838|NCT00883779|3140001|Superiority or Other||Hazard Ratio (HR)|1.37|||=|0|2-Sided|95.0|0.92|2.03|||Log Rank|||OS in subgroup non-adenocarcinoma|
1706601|NCT00887224|3139564|Superiority or Other||Mean Difference (Final Values)|0.58|||<|0.0023|2-Sided|95.0|0.21|0.95||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3|
1706602|NCT00887224|3139564|Superiority or Other||Mean Difference (Final Values)|0.53|||<|0.0069|2-Sided|95.0|0.15|0.91||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2|
1706603|NCT00887224|3139564|Superiority or Other||Mean Difference (Final Values)|0.01|||<|0.9142|2-Sided|95.0|-0.24|0.27||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1|
1706604|NCT00887224|3139565|Superiority or Other||Mean Difference (Final Values)|2.35|||<|0.001|2-Sided|95.0|1.39|3.32||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26|
1706605|NCT00887224|3139565|Superiority or Other||Mean Difference (Final Values)|2.3|||<|0.001|2-Sided|95.0|1.31|3.3||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22|
1706606|NCT00887224|3139565|Superiority or Other||Mean Difference (Final Values)|1.95|||<|0.001|2-Sided|95.0|1.06|2.84||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18|
1706607|NCT00887224|3139565|Superiority or Other||Mean Difference (Final Values)|2.04|||<|0.001|2-Sided|95.0|1.23|2.86||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14|
1706608|NCT00887224|3139565|Superiority or Other||Mean Difference (Final Values)|1.68|||<|0.001|2-Sided|95.0|0.83|2.54||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10|
1706609|NCT00887224|3139565|Superiority or Other||Mean Difference (Final Values)|1.63|||<|0.001|2-Sided|95.0|0.86|2.39||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6|
1706610|NCT00887224|3139565|Superiority or Other||Mean Difference (Final Values)|1.39|||<|0.001|2-Sided|95.0|0.76|2.03||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4|
1706611|NCT00887224|3139565|Superiority or Other||Mean Difference (Final Values)|0.88|||<|0.0038|2-Sided|95.0|0.28|1.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3|
1706612|NCT00887224|3139565|Superiority or Other||Mean Difference (Final Values)|0.88|||<|0.0081|2-Sided|95.0|0.23|1.52||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2|
1706613|NCT00887224|3139565|Superiority or Other||Mean Difference (Final Values)|0.03|||<|0.8853|2-Sided|95.0|-0.41|0.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1|
1706614|NCT00887224|3139566|Superiority or Other||Mean Difference (Final Values)|0.44|||<|0.001|2-Sided|95.0|0.28|0.61||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 26|
1706615|NCT00887224|3139566|Superiority or Other||Mean Difference (Final Values)|0.43|||<|0.001|2-Sided|95.0|0.25|0.62||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 22|
1706616|NCT00887224|3139566|Superiority or Other||Mean Difference (Final Values)|0.33|||<|0.001|2-Sided|95.0|0.17|0.49||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 18|
1706617|NCT00887224|3139566|Superiority or Other||Mean Difference (Final Values)|0.33|||<|0.001|2-Sided|95.0|0.19|0.47||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 14|
1706618|NCT00887224|3139566|Superiority or Other||Mean Difference (Final Values)|0.28|||<|0.001|2-Sided|95.0|0.12|0.43||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 10|
1706645|NCT00885846|3139703|Non-Inferiority or Equivalence|Regression analysis performed for equal variance at baseline.||||||0.664|||||||Repeated ANOVA|degrees of freedom = 2||Power analysis suggested 27 participants, 9 in each group.|
1706619|NCT00887224|3139566|Superiority or Other||Mean Difference (Final Values)|0.25|||<|0.001|2-Sided|95.0|0.11|0.39||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 6|
1706620|NCT00887224|3139566|Superiority or Other||Mean Difference (Final Values)|0.17|||<|0.0064|2-Sided|95.0|0.05|0.29||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 4|
1706621|NCT00887224|3139566|Superiority or Other||Mean Difference (Final Values)|0.13|||<|0.0228|2-Sided|95.0|0.02|0.25||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 3|
1706622|NCT00887224|3139566|Superiority or Other||Mean Difference (Final Values)|0.09|||<|0.1046|2-Sided|95.0|-0.02|0.21||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 2|
1706623|NCT00887224|3139566|Superiority or Other||Mean Difference (Final Values)|0.0|||<|0.9627|2-Sided|95.0|-0.09|0.08||"P-value obtained from mixed model: change from baseline = baseline + site + treatment + visit + treatment*visit with Unstructured covariance structure."|Mixed Models Analysis|Mixed-effects model for repeated measures (MMRM).||Adjusted difference from placebo: Week 1|
1706624|NCT00887224|3139568|Superiority or Other||||||<|0.001||||||Significance declared if p-value ≤0.05. The estimated probability obtained via Kaplan-Meier estimate.|Log Rank||||
1706625|NCT00887159|3139580|Superiority or Other||Hazard Ratio (HR)|1.69||||0.01|2-Sided|95.0|1.13|2.52|||Regression, Cox||Hazard ratio was derived comparing the high CTCs group to the low CTCs group.||
1706626|NCT00887159|3139583|Superiority or Other||Hazard Ratio (HR)|0.99||||0.48|2-Sided|95.0|0.66|1.48||P-value is one-sided.|Regression, Cox||Hazard ratio was derived comparing Arm C to Arm A.|There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.|
1706627|NCT00887159|3139583|Superiority or Other||Hazard Ratio (HR)|0.98||||0.45|2-Sided|95.0|0.65|1.47||P-value is one-sided.|Regression, Cox||The hazard ratio was derived comparing Arm B to Arm A.|There are 2 primary comparisons and each involves comparing the experimental arms (B, C) to the control arm (A). Accrual goal was 54 patients per arm. With a 1-sided 0.1 level logrank test for each test, we have 90% power to detect a 42% reduction in the PFS hazard rate of 0.139 to 0.082 (corresponding to an improvement in median PFS of 5 months to 8.5 months) with 18-month accrual and 12-month follow-up; assuming exponential survival. For each test, 94 events are needed to achieve this power.|
1706628|NCT00886834|3139592|Superiority or Other|||||||0.64|||||||t-test, 2 sided||||
1706629|NCT00886613|3139658|Superiority or Other||Difference in proportions|0.06||||0.343|2-Sided|90.0|-0.17|0.28|||Chi-squared||Statistical analysis for dose 2||
1706630|NCT00886613|3139660|Superiority or Other||kappa coefficient of agreement|0.85||||0.564|2-Sided|90.0|0.72|0.99|||McNemar||The significance of the difference between the proportion of subjects with a positive skin test at 48 hours and the proportion of subjects with a positive skin test at 72 hours||
1706631|NCT00886587|3139668|Superiority or Other||Estimated Mean Difference|0.03||||0.9508|2-Sided|95.0|-0.9|0.96||The significance threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1706632|NCT00886587|3139669|Superiority or Other||Estimated Mean Difference|-0.06||||0.788|2-Sided|95.0|-0.47|0.36||The significance threshold level was 0.05 (two-sided).|ANCOVA|Treatment as a factor, baseline score as covariate.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1706633|NCT00886587|3139670|Superiority or Other||Estimated Mean Difference|0.35||||0.5431|2-Sided|95.0|-0.78|1.48||The significance level threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1706634|NCT00886587|3139671|Superiority or Other||Estimated Mean Difference|0.04||||0.9416|2-Sided|95.0|-1.09|1.17||The significance threshold level was 0.05 (two-sided).|Repeated measures ANCOVA|Treatment, visit number, and treatment-visit number interaction term as factors, with baseline score and age as covariates.||The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.|
1706635|NCT00886340|3139681|Superiority or Other|||||||0.08||||||controlled for site, income, race/ethnicity|Mixed Models Analysis|||pilot test, used 20% of sample required for a full test of the hypothesis|
1706636|NCT00886288|3139687|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1706637|NCT00886015|3139697|Superiority or Other||Odds Ratio (OR)|1.22|||||2-Sided|95.0|0.97|1.53|||||||
1706638|NCT00886015|3139698|Superiority or Other||Odds Ratio (OR)|0.62|||||2-Sided|95.0|0.35|1.1||||||Severe ECA compared with Normal|
1706639|NCT00886015|3139698|Superiority or Other||Odds Ratio (OR)|0.63|||||2-Sided|95.0|0.39|1.01||||||Moderate ECA compared with Normal|
1706640|NCT00886015|3139698|Superiority or Other||Odds Ratio (OR)|0.64|||||2-Sided|95.0|0.42|0.97||||||Mild ECA compared with Normal|
1706641|NCT00886015|3139699|Superiority or Other||Odds Ratio (OR)|0.65|||||2-Sided|95.0|0.44|0.98|||||||
1706642|NCT00886015|3139700|Superiority or Other||Odds Ratio (OR)|0.88|||||2-Sided|95.0|0.66|1.18|||||||
1706643|NCT00886015|3139701|Superiority or Other||Odds Ratio (OR)|0.67|||||2-Sided|95.0|0.46|0.98|||||||
1706644|NCT00886015|3139702|Superiority or Other||Odds Ratio (OR)|1.36|||||2-Sided|95.0|0.96|1.93|||||||
1706646|NCT00885755|3139714|Superiority or Other||Odds Ratio (OR)|0.083|||||2-Sided|95.0|0.004|1.945||||||Univariate logistic regression Odds ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H|
1706647|NCT00885755|3139714|Superiority or Other||Odds Ratio (OR)|1.0|||||2-Sided|95.0|0.053|18.915||||||Univariate logistic regressionOdds ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.|
1706648|NCT00885755|3139714|Superiority or Other||Odds Ratio (OR)|0.148|||||2-Sided|95.0|0.012|1.9||||||Univariate logistic regression Odds ratio (PI3K mutation status: WT versus M) for the biomarker PI3K Amino Acids.|
1706649|NCT00885755|3139714|Superiority or Other||Odds Ratio (OR)|0.857|||||2-Sided|95.0|0.091|8.075||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥median /< median) for the biomarker HER2.|
1706650|NCT00885755|3139714|Superiority or Other||Odds Ratio (OR)|1.875|||||2-Sided|95.0|0.15|23.396||||||Univariate logistic regression Odds ratio (Cytoplasm H-Score: ≥ median /< median) for the biomarker PTEN.|
1706651|NCT00885755|3139714|Superiority or Other||Odds Ratio (OR)|2.143|||||2-Sided|95.0|0.169|27.103||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥ median /<median) for the biomarker c-MET.|
1706652|NCT00885755|3139714|Superiority or Other||Odds Ratio (OR)|0.208|||||2-Sided|95.0|0.017|2.6||||||Univariate logistic regression Odds ratio (Membrane H-Score: ≥median /<median) for the biomarker IGF1R.|
1706653|NCT00885755|3139714|Superiority or Other||Odds Ratio (OR)|0.03|||||2-Sided|95.0|0.001|0.641||||||Univariate logistic regression Odds ratio (Positive / Negative) for the biomarker p95 HER 2.|
1706654|NCT00885755|3139722|Superiority or Other||Hazard Ratio (HR)|1.292|||||2-Sided|95.0|0.296|5.64||||||Univariate Cox regression Hazard ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H.|
1706655|NCT00885755|3139722|Superiority or Other||Hazard Ratio (HR)|0.956|||||2-Sided|95.0|0.098|9.319||||||Univariate Cox regression Hazard ratio (Phenotype: HH / RR) for the biomarker FC Gamma Receptor IIa R166H.|
1706656|NCT00885755|3139722|Superiority or Other||Hazard Ratio (HR)|0.576|||||2-Sided|95.0|0.067|4.968||||||Univariate Cox regression Hazard ratio (Phenotype: HH / HR) for the biomarker FC Gamma Receptor IIa R166H.|
1706657|NCT00885755|3139722|Superiority or Other||Hazard Ratio (HR)|1.732|||||2-Sided|95.0|0.235|12.783||||||Hazard ratio (Phenotype: VF / VV) for the biomarker FC Gamma Receptor IIIa F176V.|
1706658|NCT00885755|3139722|Superiority or Other||Hazard Ratio (HR)|1.666|||||2-Sided|95.0|0.298|9.305||||||Hazard ratio (Phenotype: FF / VV) for the biomarker FC Gamma Receptor IIIa F176V.|
1706659|NCT00885755|3139722|Superiority or Other||Hazard Ratio (HR)|0.957|||||2-Sided|95.0|0.172|5.336||||||Hazard ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.|
1706660|NCT00885755|3139722|Superiority or Other||Hazard Ratio (HR)|1.11|||||2-Sided|95.0|0.337|3.632||||||Univariate Cox regressionHazard ratio (Mutation Status: Wild type / Mutation) for the biomarker PI3K amino acids.|
1706661|NCT00885755|3139722|Superiority or Other||Hazard Ratio (HR)|0.81|||||2-Sided|95.0|0.242|2.733||||||Univariate Cox regression Hazard ratio (Membrane H-Score: < median / ≥median) for the biomarker HER2.|
1706662|NCT00885755|3139722|Superiority or Other||Hazard Ratio (HR)|0.57|||||2-Sided|95.0|0.183|1.768||||||Univariate Cox regression Hazard ratio (Cytoplasm H-Score: < median / ≥median) for the marker PTEN.|
1706663|NCT00885755|3139722|Superiority or Other||Hazard Ratio (HR)|0.82|||||2-Sided|95.0|0.268|2.514||||||Univariate Cox regression Hazard ratio (Membrane H-Score: < median / ≥median) for the biomarker c-met.|
1706664|NCT00885755|3139722|Superiority or Other||Hazard Ratio (HR)|1.18|||||2-Sided|95.0|0.394|3.518||||||Univariate Cox regressionHazard ratio (Membrane H-Score: <median / ≥median) for the biomarker IGF1R.|
1706665|NCT00885755|3139722|Superiority or Other||Hazard Ratio (HR)|0.46|||||2-Sided|95.0|0.12|1.79||||||Univariate Cox regression Hazard ratio (Positive / Negative) for the biomarker p95 HER2.|
1706666|NCT00885755|3139725|Superiority or Other||Hazard Ratio (HR)|1.073|||||2-Sided|95.0|0.274|4.199||||||Univariate Cox regression Hazard ratio (Phenotype: HR / RR) for the biomarker FC Gamma Receptor IIa R166H.|
1706667|NCT00885755|3139725|Superiority or Other||Hazard Ratio (HR)|0.743|||||2-Sided|95.0|0.082|6.72||||||Univariate Cox regression Hazard ratio (Phenotype: HH / RR) for the biomarker FC Gamma Receptor IIa R166H.|
1706668|NCT00885755|3139725|Superiority or Other||Hazard Ratio (HR)|0.576|||||2-Sided|95.0|0.067|4.968||||||Univariate Cox regression Hazard ratio (Phenotype: HH / HR) for the biomarker FC Gamma Receptor IIa R166H.|
1706669|NCT00885755|3139725|Superiority or Other||Hazard Ratio (HR)|1.732|||||2-Sided|95.0|0.235|12.783||||||Univariate Cox regression Hazard ratio (Phenotype: VF / VV) for the biomarker FC Gamma Receptor IIIa F176V.|
1706670|NCT00885755|3139725|Superiority or Other||Hazard Ratio (HR)|1.989|||||2-Sided|95.0|0.378|10.47||||||Univariate Cox regression Hazard ratio (Phenotype: FF / VV) for the biomarker FC Gamma Receptor IIIa F176V.|
1706671|NCT00885755|3139725|Superiority or Other||Hazard Ratio (HR)|1.183|||||2-Sided|95.0|0.226|6.197||||||Univariate Cox regression Hazard ratio (Phenotype: FF / VF) for the biomarker FC Gamma Receptor IIIa F176V.|
1706672|NCT00885755|3139725|Superiority or Other||Hazard Ratio (HR)|1.3|||||2-Sided|95.0|0.409|4.132||||||Univariate Cox regression Hazard ratio (Mutation Status: Wild type / Mutation) for the biomarker PI3K amino acids.|
1706673|NCT00885755|3139725|Superiority or Other||Hazard Ratio (HR)|1.09|||||2-Sided|95.0|0.377|3.16||||||Univariate Cox regression Hazard ratio (Membrane H-Score: < median / ≥median) for the biomarker HER2.|
1706674|NCT00885755|3139725|Superiority or Other||Hazard Ratio (HR)|0.49|||||2-Sided|95.0|0.164|1.453||||||Univariate Cox regression Hazard ratio (Cytoplasm H-Score: <median / ≥median) for the biomarker PTEN.|
1706675|NCT00885755|3139725|Superiority or Other||Hazard Ratio (HR)|0.86|||||2-Sided|95.0|0.306|2.425||||||Univariate Cox regression Hazard ratio (Membrane H-Score: <median / ≥median) for the biomarker c-MET.|
1706676|NCT00885755|3139725|Superiority or Other||Hazard Ratio (HR)|1.19|||||2-Sided|95.0|0.43|3.282||||||Univariate Cox regression: Hazard ratio (Membrane H-Score: <median / ≥median) for the biomarker IGF1R.|
1706677|NCT00885755|3139725|Superiority or Other||Hazard Ratio (HR)|0.41|||||2-Sided|95.0|0.109|1.535||||||Univariate Cox regression Hazard ratio (Positive / Negative) for the biomarker p95.|
1706678|NCT00885703|3139741|Superiority|||||||0.1766||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 2000mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.|
1709136|NCT00852995|3144526|Superiority or Other|||||||0.041||||||Week 10|Cochran-Mantel-Haenszel||||
1706679|NCT00885703|3139741|Superiority|||||||0.4828||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 1600mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.|
1706680|NCT00885703|3139741|Superiority|||||||0.0894||||||Analysis did not adjust for multiple comparisons.|Log Rank|||Comparison of survival from entry to week 24 between Fluconazole 1200mg arm and Ampho B arm. The null hypothesis is there is no difference in survival between these two arms.|
1706681|NCT00885703|3139742|Superiority|||||||0.019|||||||Kruskal-Wallis|||Comparison of change in quantitative CSF culture among 4 treatment arms. The null hypothesis is the 4 treatment arms have the same change in CSF culture from entry to week 2.|
1706682|NCT00885703|3139743|Superiority|||||||0.012|||||||Fisher Exact|||Among 4 treatment arms, comparison of three categorical groups: (CM negative, CM negative after switching treatment, and CM Positive/Died/Lost to Follow-up) at week 10. The null hypothesis is the 4 treatment arms have no differences at week 10.|
1706683|NCT00885703|3139744|Superiority|||||||0.0012||||||Analysis did not adjust for multiple comparisons.|Chi-squared|||Testing discontinuation of any dose Fluconazole (pooled by treatment and dose) versus discontinuation of Ampho B (pooled). The null hypothesis is the two treatments have the same proportion of discontinuation.|
1706684|NCT00885378|3139761|Superiority or Other||Standard Error of the Mean|-0.34||||0.0063|2-Sided|95.0|-0.58|-0.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo at Week 12(LOCF) was adjusted for baseline.|difference between week t value - baseline value = baseline value + treatment.||
1706685|NCT00885378|3139768|Superiority or Other||Mean Difference (Final Values)|13.8|||||2-Sided|95.0|3.0|24.7|||||Adjusted for baseline.||
1706686|NCT00885378|3139769|Superiority or Other||Mean Difference (Final Values)|13.2|||||2-Sided|95.0|1.1|25.4|||||Adjusted for baseline.||
1706687|NCT00885378|3139770|Superiority or Other||Mean Difference (Final Values)|-9.51|Standard Error of the Mean|6.162||0.1248|2-Sided|95.0|-21.68|2.66|||ANCOVA|ANCOVA model: post - pre = pretreatment.|Estimate = adjusted mean change for Saxagliptin - adjusted mean change for Placebo.||
1706688|NCT00885365|3139775|Superiority or Other|||||||0.128||||||A priori threshold for statistical significance is <= 0.050.|Cochran-Mantel-Haenszel|Test controlling for country.||Week 8|
1706689|NCT00885365|3139775|Superiority or Other|||||||0.692||||||A priori threshold for statistical significance is <= 0.050.|Cochran-Mantel-Haenszel|Test controlling for country.||Week 4|
1706690|NCT00885365|3139778|Superiority or Other||difference of least square means|0.04|Standard Error of the Mean|0.18||0.82|2-Sided|95.0|-0.31|0.39||A priori threshold for statistical significance is <= 0.050.|ANCOVA|treatment and country are fixed effects and baseline log10 bacterial load (CFU/g) value is a covariate||Analysis of Week 4 data|
1706691|NCT00885365|3139779|Superiority or Other||difference of least square means|0.04||||0.505|2-Sided|95.0|-0.08|0.15|||ANCOVA|||Analysis for Week 4|
1706692|NCT00885365|3139780|Superiority or Other||difference of least square means|0.51||||0.777|2-Sided|95.0|-3.06|4.09|||ANCOVA|||Analysis for Week 4|
1706693|NCT00885365|3139781|Superiority or Other||difference of least square means|-0.02||||0.693|2-Sided|95.0|-0.09|0.06|||ANCOVA|||Analysis for Week 4|
1706694|NCT00885365|3139782|Superiority or Other||difference of least square means|-0.55||||0.63|2-Sided|95.0|-2.78|1.69|||ANCOVA|||Analysis for Week 4|
1706695|NCT00885365|3139783|Superiority or Other||difference of least square means|-0.01||||0.634|2-Sided|95.0|-0.08|0.05|||ANCOVA|||Analysis for Week 4|
1706696|NCT00885365|3139785|Non-Inferiority or Equivalence|The non-inferiority is shown if the lower limit of the two-sided 95% confidence interval is above the non-inferiority margin set at -4.5%.|difference of least square means|-0.5||||0.64|2-Sided|95.0|-2.58|1.59|||ANCOVA|||Based on previous studies, the difference between reference and placebo after 4-week treatment is assumed to be about 12% and the non-inferiority margin safely placed at 4.5%. With a between-patient SD of 13.5% and estimated difference between treatments of zero, sample size of 143 per group allows a 80% power to show the non-inferiority of Bramitob® versus TOBI®. Accounting for an expected dropout rate of 11%, a minimum of 160 participants per group is required.|
1706697|NCT00885170|3139789|Superiority or Other||Difference in the Least Squares Means|-3.13||||0.376|2-Sided|95.0|-10.04|3.78|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.||
1706698|NCT00885170|3139790|Superiority or Other||Difference in the Least Squares Means|1.47||||0.835|2-Sided|95.0|-12.37|15.32|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.||
1706699|NCT00885170|3139791|Superiority or Other||Difference in the Least Squares Means|-5.91||||0.326|2-Sided|95.0|-17.66|5.85|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.||
1706700|NCT00885170|3139792|Superiority or Other||Difference in the Least Squares Means|1.38||||0.413|2-Sided|95.0|-1.91|4.67|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.||
1706701|NCT00885170|3139793|Superiority or Other||Difference in the Least Squares Means|0.11||||0.846|2-Sided|95.0|-0.95|1.16|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.||
1706702|NCT00885170|3139794|Superiority or Other||Difference in the Least Squares Means|24.01||||0.059|2-Sided|95.0|-0.93|48.94|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.||
1706796|NCT00884221|3139952|Superiority or Other||||||<|0.001|||||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Estradiol|
1706703|NCT00885170|3139795|Superiority or Other||Difference in the Least Squares Means|31.17||||0.011|2-Sided|95.0|7.13|55.21|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.||
1706704|NCT00885170|3139796|Superiority or Other||Difference in the Least Squares Means|12.82||||0.015|2-Sided|95.0|2.54|23.1|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.||
1706705|NCT00885170|3139797|Superiority or Other||Difference in the Least Squares Means|10.96||||0.186|2-Sided|95.0|-5.29|27.22|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.||
1706706|NCT00885170|3139798|Superiority or Other||Difference in the Least Squares Means|-46.29|||<|0.001|2-Sided|95.0|-61.43|-31.15|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.||
1706707|NCT00885170|3139799|Superiority or Other||Difference in the Least Squares Means|-47.04|||<|0.001|2-Sided|95.0|-62.4|-31.67|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.||
1706708|NCT00885170|3139800|Superiority or Other||Difference in the Least Squares Means|-5.82||||0.709|2-Sided|95.0|-36.29|24.65|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.||
1706709|NCT00885170|3139801|Superiority or Other||Difference in the Least Squares Means|10.16||||0.5|2-Sided|95.0|-19.39|39.72|||cLDA||Log-transformed baseline and post-baseline measurements up to Month 24, with fixed effects for treatment, time, duration of prior alendronate use, geographical region, the interaction of time-by-treatment and the time-by-factor interactions.||
1706710|NCT00885170|3139802|Superiority or Other||Difference in the Least Squares Means|0.38||||0.578|2-Sided|95.0|-0.96|1.72|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction||
1706711|NCT00885170|3139803|Superiority or Other||Difference in the Least Squares Means|0.22||||0.763|2-Sided|95.0|-1.23|1.67|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction||
1706712|NCT00885170|3139804|Superiority or Other||Difference in the Least Squares Means|0.8||||0.103|2-Sided|95.0|-0.16|1.77|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction||
1706713|NCT00885170|3139805|Superiority or Other||Difference in the Least Squares Means|2.57|||<|0.001|2-Sided|95.0|1.26|3.89|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction||
1706714|NCT00885170|3139806|Superiority or Other||Difference in the Least Squares Means|1.06||||0.023|2-Sided|95.0|0.15|1.98|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction||
1706715|NCT00885170|3139807|Superiority or Other||Difference in the Least Squares Means|2.7|||<|0.001|2-Sided|95.0|1.41|4.0|||cLDA||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction||
1706716|NCT00885170|3139808|Superiority or Other||Difference in the Least Squares Means|1.0||||0.142|2-Sided|95.0|-0.34|2.35|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction||
1706717|NCT00885170|3139809|Superiority or Other||Difference in the Least Squares Means|3.18||||0.002|2-Sided|95.0|1.19|5.17|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction||
1706718|NCT00885170|3139810|Superiority or Other||Difference in the least Squares Means|0.88||||0.166|2-Sided|95.0|-0.37|2.14|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction||
1706719|NCT00885170|3139811|Superiority or Other||Difference in the Percentage vs. Placebo|5.7|||||2-Sided|95.0|-0.4|12.6|||||Based on Miettinen & Nurminen method.||
1706720|NCT00885170|3139812|Superiority or Other||Difference in Percentages vs. Placebo|-5.5|||||2-Sided|95.0|-16.9|6.0|||||Based on Miettinen & Nurminen method.||
1706721|NCT00885170|3139813|Superiority or Other||Difference in the Least Squares Means|2.67|||<|0.001|2-Sided|95.0|1.17|4.17|||Constrained longitudinal data analysis||Baseline measurement and post-baseline percent changes from baseline, with fixed effects for treatment, time, duration of prior alendronate use (3-5 years, >5 years), geographic region, machine type (Lunar/Hologic) and treatment-by-time interaction|The primary hypothesis of the study was met if; in postmenopausal women previously treated with alendronate with low BMD, two years of treatment with odanacatib 50 mg significantly increased BMD at the femoral neck site compared to placebo (p-value < 0.001).|
1706722|NCT00885118|3139834|Superiority or Other||Mean Difference (Final Values)|-10.118|Standard Error of the Mean|4.137||0.0164|2-Sided|95.0|-18.339|-1.897|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo|
1706723|NCT00885118|3139834|Superiority or Other||Mean Difference (Final Values)|-15.642|Standard Error of the Mean|4.131||0.0003|2-Sided|95.0|-23.853|-7.432|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo|
1706724|NCT00885118|3139834|Superiority or Other||Mean Difference (Final Values)|-14.344|Standard Error of the Mean|3.966||0.0005|2-Sided|95.0|-22.225|-6.462|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo|
1706725|NCT00885118|3139834|Superiority or Other||Mean Difference (Final Values)|-8.869|Standard Error of the Mean|4.066||0.0318|2-Sided|95.0|-16.949|-0.789|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo|
1706726|NCT00885118|3139835|Superiority or Other||Mean Difference (Final Values)|11.015|Standard Error of the Mean|13.612||0.4206|2-Sided|95.0|-16.036|38.066|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo|
1706727|NCT00885118|3139835|Superiority or Other||Mean Difference (Final Values)|5.974|Standard Error of the Mean|13.289||0.6541|2-Sided|95.0|-20.434|32.382|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo|
1706728|NCT00885118|3139835|Superiority or Other||Mean Difference (Final Values)|30.576|Standard Error of the Mean|12.941||0.0203|2-Sided|95.0|4.859|56.293|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo|
1706729|NCT00885118|3139835|Superiority or Other||Mean Difference (Final Values)|22.668|Standard Error of the Mean|13.152||0.0883|2-Sided|95.0|-3.47|48.805|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo|
1706730|NCT00885118|3139836|Superiority or Other||Mean Difference (Final Values)|-136.341|Standard Error of the Mean|15.357|<|0.0001|2-Sided|95.0|-166.86|-105.823|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo|
1706731|NCT00885118|3139836|Superiority or Other||Mean Difference (Final Values)|-131.336|Standard Error of the Mean|15.354|<|0.0001|2-Sided|95.0|-161.848|-100.824|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo|
1706732|NCT00885118|3139836|Superiority or Other||Mean Difference (Final Values)|-109.48|Standard Error of the Mean|14.67|<|0.0001|2-Sided|95.0|-138.633|-80.327|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo|
1706733|NCT00885118|3139836|Superiority or Other||Mean Difference (Final Values)|-95.414|Standard Error of the Mean|15.388|<|0.0001|2-Sided|95.0|-125.995|-64.833|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo|
1706734|NCT00885118|3139837|Superiority or Other||Mean Difference (Final Values)|-1.257|Standard Error of the Mean|0.421||0.0037|2-Sided|95.0|-2.094|-0.419|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo|
1706735|NCT00885118|3139837|Superiority or Other||Mean Difference (Final Values)|-1.343|Standard Error of the Mean|0.416||0.0018|2-Sided|95.0|-2.171|-0.516|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo|
1706736|NCT00885118|3139837|Superiority or Other||Mean Difference (Final Values)|-0.379|Standard Error of the Mean|0.408||0.3544|2-Sided|95.0|-1.189|0.43|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo|
1706737|NCT00885118|3139837|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.414||0.2498|2-Sided|95.0|-1.302|0.343|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo|
1706738|NCT00885118|3139838|Superiority or Other||Mean Difference (Final Values)|-4.887|Standard Error of the Mean|1.076|<|0.0001|2-Sided|95.0|-7.048|-2.726|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo|
1706739|NCT00885118|3139838|Superiority or Other||Mean Difference (Final Values)|-4.036|Standard Error of the Mean|0.762|<|0.0001|2-Sided|95.0|-5.565|-2.508|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo|
1706740|NCT00885118|3139838|Superiority or Other||Mean Difference (Final Values)|-4.609|Standard Error of the Mean|0.756|<|0.0001||95.0|-6.126|-3.091|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo|
1706741|NCT00885118|3139838|Superiority or Other||Mean Difference (Final Values)|-4.192|Standard Error of the Mean|0.728|<|0.0001|2-Sided|95.0|-5.653|-2.731|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo|
1706742|NCT00885118|3139839|Superiority or Other||Mean Difference (Final Values)|-19.838|Standard Error of the Mean|18.13||0.2768|2-Sided|95.0|-55.869|16.192|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo|
1706743|NCT00885118|3139839|Superiority or Other||Mean Difference (Final Values)|-17.858|Standard Error of the Mean|17.903||0.3213|2-Sided|95.0|-53.438|17.721|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo|
1706744|NCT00885118|3139839|Superiority or Other||Mean Difference (Final Values)|5.984|Standard Error of the Mean|17.313||0.7305|2-Sided|95.0|-28.422|40.39|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo|
1706745|NCT00885118|3139839|Superiority or Other||Mean Difference (Final Values)|12.527|Standard Error of the Mean|17.755||0.4823|2-Sided|95.0|-22.757|47.811|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo|
1706746|NCT00885118|3139840|Superiority or Other||Mean Difference (Final Values)|-0.395|Standard Error of the Mean|0.131||0.0033|2-Sided|95.0|-0.654|-0.135|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo|
1706747|NCT00885118|3139840|Superiority or Other||Mean Difference (Final Values)|-0.429|Standard Error of the Mean|0.13||0.0014|2-Sided|95.0|-0.687|-0.17|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo|
1706956|NCT00880750|3140419|Superiority or Other||Median Difference (Final Values)|0.01||||||90.0|0.0|0.5|||||||
1706748|NCT00885118|3139840|Superiority or Other||Mean Difference (Final Values)|-0.296|Standard Error of the Mean|0.125||0.0203|2-Sided|95.0|-0.545|-0.047|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo|
1706749|NCT00885118|3139840|Superiority or Other||Mean Difference (Final Values)|-0.239|Standard Error of the Mean|0.13||0.0705|2-Sided|95.0|-0.498|-0.02|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo|
1706750|NCT00885118|3139841|Superiority or Other||Mean Difference (Final Values)|-28.34|Standard Error of the Mean|5.699|<|0.0001|2-Sided|95.0|-39.665|-17.015|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo|
1706751|NCT00885118|3139841|Superiority or Other||Mean Difference (Final Values)|-26.265|Standard Error of the Mean|5.785|<|0.0001|2-Sided|95.0|-37.762|-14.768|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo|
1706752|NCT00885118|3139841|Superiority or Other||Mean Difference (Final Values)|-22.487|Standard Error of the Mean|5.445|<|0.0001|2-Sided|95.0|-33.308|-11.665|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo|
1706753|NCT00885118|3139841|Superiority or Other||Mean Difference (Final Values)|-17.883|Standard Error of the Mean|5.861|<|0.003|2-Sided|95.0|-29.529|-6.236|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo|
1706754|NCT00885118|3139842|Superiority or Other||Mean Difference (Final Values)|-27.235|Standard Error of the Mean|4.202|<|0.0001|2-Sided|95.0|-35.586|-18.884|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo|
1706755|NCT00885118|3139842|Superiority or Other||Mean Difference (Final Values)|-26.208|Standard Error of the Mean|4.168|<|0.0001|2-Sided|95.0|-34.49|-17.925|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo|
1706756|NCT00885118|3139842|Superiority or Other||Mean Difference (Final Values)|-19.92|Standard Error of the Mean|4.025|<|0.0001|2-Sided|95.0|-27.919|-11.921|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo|
1706757|NCT00885118|3139842|Superiority or Other||Mean Difference (Final Values)|-12.68|Standard Error of the Mean|4.155|<|0.003|2-Sided|95.0|-20.936|-4.424|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 1mg minus placebo|
1706758|NCT00885118|3139843|Superiority or Other||Mean Difference (Final Values)|85620.348|Standard Error of the Mean|6610.091|<|0.0001|2-Sided|95.0|72484.181|98756.515|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 25mg minus placebo|
1706759|NCT00885118|3139843|Superiority or Other||Mean Difference (Final Values)|88589.764|Standard Error of the Mean|6544.604|<|0.0001|2-Sided|95.0|75583.738|101595.79|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 10mg minus placebo|
1706760|NCT00885118|3139843|Superiority or Other||Mean Difference (Final Values)|80964.677|Standard Error of the Mean|6303.82|<|0.0001|2-Sided|95.0|68437.16|93492.194|||ANCOVA|The baseline value was included as a continuous covariate||Difference calculated as empa 5mg minus placebo|
1706761|NCT00885118|3139843|Superiority or Other||Mean Difference (Final Values)|42828.482|Standard Error of the Mean|6487.174|<|0.0001|2-Sided|95.0|29936.586|55720.378|||ANCOVA|The baseline value was included as a continuous covariate.||Difference calculated as empa 1mg minus placebo|
1706762|NCT00885079|3139853|Superiority or Other||Mean Difference (Final Values)|-2.1|||<|0.05|||||||t-test, 2 sided||||
1706763|NCT00885079|3139854|Non-Inferiority or Equivalence|Non-inferiority for change from baseline in the FCS score was determined by comparing the non-inferiority margin (0.4) with the upper limit of the confidence interval of the difference between the 2 treatment groups.|Mean Difference (Final Values)|-0.9|Standard Deviation|2.1|<|0.05|2-Sided|95.0|-1.47|-0.24||An analysis of change from baseline of FCS was performed using t-test. The level of singnificanse was 5 % (2-sided).|t-test, 2 sided||||
1706764|NCT00884832|3139865|Superiority or Other|||||||0.082|||||||ANCOVA||||
1706765|NCT00884832|3139867|Superiority or Other|||||||0.047|||||||ANCOVA|||drug*group interactions|
1706766|NCT00884832|3139867|Superiority or Other|||||||0.018|||||||ANCOVA||||
1706767|NCT00884832|3139868|Superiority or Other||||||<|0.001|||||||ANCOVA|||Proportion of semi-formed and loose stools (Bristol Form 5-7) associated with diarrhea subgroup versus no diarrhea subgroup.|
1706768|NCT00884741|3139887|Superiority or Other|||||||0.42||||||Two-sided|Chi-squared||||
1706769|NCT00884741|3139888|Superiority or Other||Cox Proportional Hazard|0.79||||0.004|2-Sided|95.0|0.66|0.94||To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|Log Rank|||The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|
1706770|NCT00884741|3139889|Superiority or Other||Cox Proportional Hazard|1.13||||0.11|2-Sided|95.0|0.93|1.37||To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|Log Rank|||The trial was designed to concurrently provide 80% power for the detection of a 25% relative reduction in mortality hazard (hazard ratio .75) and 30% reduction in progression hazard (hazard ratio .70) for the addition of bevacizumab to temozolomide and radiation. To control for type I error in testing the co-primary endpoints, the significance criterion for OS was 0.023 (one-sided) and for PFS was 0.002 (one-sided).|
1706771|NCT00884273|3139928|Non-Inferiority or Equivalence|"Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.~If the Week 12 treatment assessment of prostate volume was missing the LOCF approach was used, i.e., the prostate volume value closest to and before Week 12 was used."|Mean Difference (Net)|2.24||||0.41|2-Sided|95.0|-3.1|7.58||PP.|ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.|
1709137|NCT00852995|3144526|Superiority or Other|||||||0.021||||||Week 09|Cochran-Mantel-Haenszel||||
1706772|NCT00884273|3139937|Non-Inferiority or Equivalence|"Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.~If the Week 12 treatment assessment of prostate volume was missing the LOCF approach was used, i.e., the prostate volume value closest to and before Week 12 was used."|Mean Difference (Final Values)|2.37||||0.36|2-Sided|95.0|-2.78|7.52||FAS.|ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.|
1706773|NCT00884221|3139938|Superiority or Other||Comparison of distributions|1.8||||0.686|2-Sided|95.0|-5.6|9.2|||Wilcoxon (Mann-Whitney)|A two-sided 95% confidence interval for the difference in cumulative live birth rates was made. The CI was based on a normal approximation.|Estimated value is difference between highly purified menotrophin and recombinant FSH, ITT analysis set||
1706774|NCT00884221|3139939|Superiority or Other||Comparison of distributions|0.398||||0.398|2-Sided|95.0|-3.6|9.1|||Wilcoxon (Mann-Whitney)|A two-sided 95% confidence interval for the difference in live birth rates was made. The CI was based on a normal approximation.|Estimated value is difference between highly purified menotrophin and recombinant FSH, ITT analysis set||
1706775|NCT00884221|3139940|Superiority or Other|||||||0.954|||||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status, inner cell mass grading and trophectoderm grading 5AA / 2pn|
1706776|NCT00884221|3139940|Superiority or Other|||||||0.958|||||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status, inner cell mass grading and trophectoderm grading 4AA / 2pn|
1706777|NCT00884221|3139940|Superiority or Other|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 5 / 2pn|
1706778|NCT00884221|3139940|Superiority or Other|||||||0.438|||||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 4 / 2pn|
1706779|NCT00884221|3139940|Superiority or Other|||||||0.412|||||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 3 / 2pn|
1706780|NCT00884221|3139940|Superiority or Other|||||||0.232|||||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 2 / 2pn|
1706781|NCT00884221|3139940|Superiority or Other|||||||0.406|||||||Wilcoxon (Mann-Whitney)|||Comparison between treatments groups of percentage of blastocysts with expansion and hatching status 1 / 2pn|
1706782|NCT00884221|3139941|Superiority or Other|||||||0.969|||||||Wilcoxon (Mann-Whitney)|Only participants who had oocytes retrieved were included in the analysis.|||
1706783|NCT00884221|3139942|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Only participants who underwent the oocyte retrieval procedure were included in the analysis||Treatments were compared using the Wilcoxon test for the average number of oocytes retrieved.|
1706784|NCT00884221|3139943|Superiority or Other|||||||0.285|||||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles >=17 mm on the last stimulation day|
1706785|NCT00884221|3139943|Superiority or Other|||||||0.728|||||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles 15-16 mm on the last stimulation day|
1706786|NCT00884221|3139943|Superiority or Other|||||||0.024|||||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles 12-14 mm on the last stimulation day|
1706787|NCT00884221|3139943|Superiority or Other|||||||0.025|||||||Wilcoxon (Mann-Whitney)|||Comparison between treatment groups of the average number of follicles >= 12 mm on the last stimulation day|
1706788|NCT00884221|3139944|Superiority or Other||||||<|0.001|||||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Testosterone|
1706789|NCT00884221|3139945|Superiority or Other|||||||0.009|||||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Sex hormone binding globulin|
1706790|NCT00884221|3139946|Superiority or Other|||||||0.047|||||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Prolactin|
1706791|NCT00884221|3139947|Non-Inferiority or Equivalence|The null hypothesis (H0) was tested against the alternative by constructing a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower-limit of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and it would be claimed that highly purified menotrophin was non-inferior to recombinant FSH with respect to ongoing pregnancy rate in a single fresh treatment cycle following a GnRH antagonist protocol.|Difference in pregnancy rates, PP|3.0||||0.387|2-Sided|95.0|-3.8|9.8||Since there was only one primary endpoint, no adjustment for multiplicity was needed for the primary analysis.|Sign test|A two-sided 95% confidence interval for the difference in ongoing pregnancy rates was made. The CI was based on a normal approximation.|Difference tested: highly purified menotrophin - recombinant FSH, PP|"The non-inferiority hypothesis to be tested for the primary endpoint was:~H0: π MENOPUR – π recombinant FSH ≤ -10.0% against the alternative H1: π MENOPUR – π recombinant FSH > -10.0%,~where π MENOPUR and π recombinant FSH denote the ongoing pregnancy rate after treatment with MENOPUR and recombinant FSH, respectively, in a single fresh treatment cycle following a GnRH antagonist protocol."|
1706792|NCT00884221|3139948|Superiority or Other|||||||0.63|||||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Progesterone|
1706793|NCT00884221|3139949|Superiority or Other||||||<|0.001|||||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Luteinizing hormone|
1706794|NCT00884221|3139950|Superiority or Other||||||<|0.001|||||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||Free Androgen Index|
1706795|NCT00884221|3139951|Superiority or Other||||||<|0.001|||||||Regression, Linear|Tests for treatment differences were based on log-transformed values and adjusted for baseline values||FSH|
1706797|NCT00884221|3139953|Non-Inferiority or Equivalence|The null hypothesis (H0) was tested against the alternative by constructing a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower-limit of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and it would be claimed that highly purified menotrophin was non-inferior to recombinant FSH with respect to ongoing pregnancy rate in a single fresh treatment cycle following a GnRH antagonist protocol.|Difference in pregnancy rates, ITT|2.2||||0.499|2-Sided|95.0|-4.2|8.6||Since there was only one primary endpoint, no adjustment for multiplicity was needed for the primary analysis.|Sign test|A two-sided 95% confidence interval for the difference in ongoing pregnancy rates was made. The CI was based on a normal approximation.|Difference tested: highly purified menotrophin-recombinant FSH, ITT analysis set|"The non-inferiority hypothesis to be tested for the primary endpoint was:~H0: π MENOPUR – π recombinant FSH ≤ -10.0% against the alternative H1: π MENOPUR – π recombinant FSH > -10.0%,~where π MENOPUR and π recombinant FSH denote the ongoing pregnancy rate after treatment with MENOPUR and recombinant FSH, respectively, in a single fresh treatment cycle following a GnRH antagonist protocol."|
1706798|NCT00884117|3139960|Superiority or Other|||||||0.2499|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible|
1706799|NCT00884117|3139961|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible|
1706800|NCT00884117|3139962|Superiority or Other|||||||0.4464|||||||Cochran-Mantel-Haenszel|||Resistant versus Susceptible|
1706801|NCT00884117|3139965|Superiority or Other||||||<|0.0001|||||||Pairwise Wilcoxon||||
1706802|NCT00884117|3139965|Superiority or Other||||||<|0.008|||||||Pairwise Wilcoxon||||
1706803|NCT00884117|3139965|Superiority or Other||||||<|0.0002|||||||Kruskal-Wallis||||
1706804|NCT00884117|3139966|Superiority or Other||||||<|0.0001|||||||Pairwise Wilcoxon||||
1706805|NCT00884117|3139966|Superiority or Other||||||<|0.008|||||||Pairwise Wilcoxon||||
1706806|NCT00884117|3139966|Superiority or Other||||||<|0.0005|||||||Kruskal-Wallis||||
1706807|NCT00884117|3139967|Superiority or Other|||||||0.03|||||||Pairwise Wilcoxon||||
1706808|NCT00884117|3139967|Superiority or Other|||||||0.009|||||||Pairwise Wilcoxon||||
1706809|NCT00884117|3139967|Superiority or Other|||||||0.015|||||||Kruskal-Wallis||||
1706810|NCT00884117|3139968|Superiority or Other||||||<|0.01|||||||Pairwise Wilcoxon||||
1706811|NCT00884117|3139968|Superiority or Other||||||<|0.01|||||||Pairwise Wilcoxon||||
1706812|NCT00884117|3139968|Superiority or Other||||||<|0.0001|||||||Kruskal-Wallis||||
1706813|NCT00884065|3139979|Superiority or Other||Mean Difference (Final Values)|3.08|Standard Error of the Mean|1.49|<|0.01|2-Sided|95.0|0.08|6.09|||t-test, 2 sided||||
1706814|NCT00884065|3139980|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|2.18|>|0.05|2-Sided|95.0|-3.81|5.01|||t-test, 2 sided||||
1706815|NCT00884065|3139981|Superiority or Other||Mean Difference (Final Values)|1.92|Standard Error of the Mean|1.72|>|0.05|2-Sided|95.0|-1.53|5.37|||t-test, 2 sided||||
1706816|NCT00884065|3139982|Superiority or Other||Mean Difference (Final Values)|7.24|Standard Error of the Mean|2.59|<|0.01|2-Sided|95.0|2.03|12.45|||t-test, 2 sided||||
1706817|NCT00884065|3139983|Superiority or Other||Mean Difference (Final Values)|11.4|Standard Error of the Mean|2.83|<|0.01||95.0|5.72|17.08|||t-test, 2 sided||||
1706818|NCT00884065|3139984|Superiority or Other||Mean Difference (Final Values)|-1.72|Standard Error of the Mean|4.08|>|0.05|2-Sided|95.0|-9.93|6.49|||t-test, 2 sided||||
1706819|NCT00884039|3139988|Superiority or Other|||||||0.57|||||||Fisher Exact||||
1706820|NCT00883779|3139989|Superiority or Other||Hazard Ratio (HR)|0.97||||0.913|2-Sided|95.0|0.6|1.59|||Log Rank||||
1706821|NCT00883779|3139990|Superiority or Other||Hazard Ratio, log|0.73|||=|0|2-Sided|95.0|0.59|0.9|||Log Rank||||
1706822|NCT00883779|3139992|Superiority or Other||Hazard Ratio (HR)|0.77|||=|0|2-Sided|95.0|0.61|0.96|||Log Rank||||
1706823|NCT00883779|3139994|Superiority or Other||Hazard Ratio (HR)|0.79|||=|0|2-Sided|95.0|0.63|0.99|||Log Rank||||
1706824|NCT00883779|3139996|Superiority or Other||Hazard Ratio (HR)|0.55|||<|0.0001|2-Sided|95.0|0.45|0.69|||Log Rank||||
1706825|NCT00883779|3139997|Superiority or Other||Hazard Ratio (HR)|0.32|||<|0.0001|2-Sided|95.0|0.21|0.5|||Log Rank||||
1706826|NCT00883779|3139998|Superiority or Other||Mean Difference (Final Values)|25.14|||<|0.0001|2-Sided|95.0|16.7|33.5|||Chi-squared|||Difference in objective response rates|
1706827|NCT00883779|3139999|Superiority or Other||Mean Difference (Final Values)|2.81|||=|0|2-Sided|95.0|-6.2|11.8|||Chi-squared|||Difference in non-progression response rates|
1706828|NCT00883779|3140001|Superiority or Other||Hazard Ratio (HR)|0.74|||=|0|2-Sided|95.0|0.4|1.36|||Log Rank|||OS of subgroup EGFR FISH negative|
1706829|NCT00883779|3140001|Superiority or Other||Hazard Ratio (HR)|0.32|||=|0|2-Sided|95.0|0.14|0.75|||Log Rank|||OS of subgroup EGFR FISH positive|
1706830|NCT00883779|3140001|Superiority or Other||Hazard Ratio (HR)|0.46|||=|0|2-Sided|95.0|0.21|1.05|||Log Rank|||OS in subgroup EGFR IHC negative|
1706831|NCT00883779|3140001|Superiority or Other||Hazard Ratio (HR)|0.58|||=|0|2-Sided|95.0|0.35|0.96|||Log Rank|||OS in EGFR IHC positive|
1706832|NCT00883779|3140001|Superiority or Other||Hazard Ratio (HR)|0.8|||=|0|2-Sided|95.0|0.59|1.08|||Log Rank|||OS in subgroup KRAS wild-type|
1706833|NCT00883779|3140001|Superiority or Other||Hazard Ratio (HR)|0.5|||=|0|2-Sided|95.0|0.19|1.28|||Log Rank|||OS in subgroup KRAS mutation|
1706834|NCT00883779|3140001|Superiority or Other||Hazard Ratio (HR)|0.78|||=|0|2-Sided|95.0|0.55|1.11|||Log Rank|||OS in subgroup EGFR wild-type|
1706835|NCT00883779|3140001|Superiority or Other||Hazard Ratio (HR)|0.72|||=|0|2-Sided|95.0|0.45|1.14|||Log Rank|||OS in subgroup EGFR mutation|
1706836|NCT00883779|3140001|Superiority or Other||Hazard Ratio (HR)|1.14|||=|0|2-Sided|95.0|0.87|1.5|||Log Rank|||OS in subgroup current/former smoker|
1706837|NCT00883779|3140001|Superiority or Other||Hazard Ratio (HR)|0.66|||=|0|2-Sided|95.0|0.49|0.89|||Log Rank|||OS in subgroup never smoked|
1708390|NCT00858208|3143286|Superiority or Other|||||||0.5692|||||||paired t-test|||Change from baseline at Week 90|
1706839|NCT00883779|3140001|Superiority or Other||Hazard Ratio (HR)|0.78|||=|0|2-Sided|95.0|0.62|0.98|||Log Rank|||OS in subgroup adenocarcinoma|
1706840|NCT00883779|3140001|Superiority or Other||Hazard Ratio (HR)|0.85|||=|0|2-Sided|95.0|0.7|1.04|||Log Rank|||OS in overall participants (FAS population)|
1706841|NCT00883779|3140002|Superiority or Other||Hazard Ratio (HR)|0.67|||=|0|2-Sided|95.0|0.37|1.22|||Log Rank|||PFS in subgroup EGFR FISH negative|
1706842|NCT00883779|3140002|Superiority or Other||Hazard Ratio (HR)|0.26|||=|0|2-Sided|95.0|0.11|0.64|||Log Rank|||PFS in subgroup EGFR FISH positive|
1706843|NCT00883779|3140002|Superiority or Other||Hazard Ratio (HR)|0.4|||=|0|2-Sided|95.0|0.18|0.88|||Log Rank|||PFS in subgroup EGFR IHC negative|
1706844|NCT00883779|3140002|Superiority or Other||Hazard Ratio (HR)|0.51|||=|0|2-Sided|95.0|0.31|0.86|||Log Rank|||PFS in subgroup EGFR IHC positive|
1706845|NCT00883779|3140002|Superiority or Other||Hazard Ratio (HR)|0.51|||<|0.0001|2-Sided|95.0|0.37|0.7|||Log Rank|||PFS in subgroup KRAS wild-type|
1706846|NCT00883779|3140002|Superiority or Other||Hazard Ratio (HR)|0.63|||=|0|2-Sided|95.0|0.25|1.58|||Log Rank|||PFS in subgroup KRAS mutation|
1706847|NCT00883779|3140002|Superiority or Other||Hazard Ratio (HR)|0.95|||=|0|2-Sided|95.0|0.67|1.34|||Log Rank|||PFS in subgroup EGFR wild-type|
1706848|NCT00883779|3140002|Superiority or Other||Hazard Ratio (HR)|0.21|||<|0.0001|2-Sided|95.0|0.12|0.35|||Log Rank|||PFS in subgroup EGFR mutation|
1706849|NCT00883779|3140002|Superiority or Other||Hazard Ratio (HR)|0.84|||=|0|2-Sided|95.0|0.64|1.1|||Log Rank|||PFS in former/current smoker subgroup|
1706850|NCT00883779|3140002|Superiority or Other||Hazard Ratio (HR)|0.39|||<|0.0001|2-Sided|95.0|0.28|0.53|||Log Rank|||PFS in never smoked subgroup|
1706851|NCT00883779|3140002|Superiority or Other||Hazard Ratio (HR)|0.9|||=|0|2-Sided|95.0|0.6|1.33|||Log Rank|||PFS in non-adenocarcinoma subgroup|
1706852|NCT00883779|3140002|Superiority or Other||Hazard Ratio (HR)|0.5|||<|0.0001|2-Sided|95.0|0.39|0.64|||Log Rank|||PFS in adenocarcinoma subgroup|
1706853|NCT00883779|3140004|Superiority or Other||Hazard Ratio (HR)|0.57|||<|0.0001|2-Sided|95.0|0.46|0.7|||Log Rank||||
1706854|NCT00883740|3140040|Superiority or Other||Mean Difference (Final Values)|25.44|||<|0.0001|2-Sided|95.0|15.03|35.86||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4|
1706855|NCT00883740|3140040|Superiority or Other||Mean Difference (Final Values)|26.79|||<|0.0001|2-Sided|95.0|15.37|38.21||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3|
1706856|NCT00883740|3140040|Superiority or Other||Mean Difference (Final Values)|29.4|||<|0.0001|2-Sided|95.0|18.59|40.21||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2|
1706857|NCT00883740|3140040|Superiority or Other||Mean Difference (Final Values)|24.82|||<|0.0001|2-Sided|95.0|13.25|36.4||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1|
1706858|NCT00883740|3140041|Superiority or Other||Mean Difference (Final Values)|-10.25||||0.0102|2-Sided|95.0|-18.01|-2.48||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4|
1706859|NCT00883740|3140041|Superiority or Other||Mean Difference (Final Values)|-13.23||||0.0085|2-Sided|95.0|-23.01|-3.46||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3|
1706860|NCT00883740|3140041|Superiority or Other||Mean Difference (Final Values)|-16.06||||0.0002|2-Sided|95.0|-24.24|-7.87||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2|
1706861|NCT00883740|3140041|Superiority or Other||Mean Difference (Final Values)|-18.27|||<|0.0001|2-Sided|95.0|-27.02|-9.52||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1|
1706862|NCT00883740|3140042|Superiority or Other||Mean Difference (Final Values)|-0.52||||0.0084|2-Sided|95.0|-0.9|-0.14||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4|
1706863|NCT00883740|3140042|Superiority or Other||Mean Difference (Final Values)|-0.59||||0.0014|2-Sided|95.0|-0.95|-0.24||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3|
1706864|NCT00883740|3140042|Superiority or Other||Mean Difference (Final Values)|-0.71||||0.0001|2-Sided|95.0|-1.06|-0.36||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2|
1706865|NCT00883740|3140042|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.0001|2-Sided|95.0|-1.02|-0.37||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1|
1706866|NCT00883740|3140043|Superiority or Other||Mean Difference (Final Values)|-6.18||||0.0081|2-Sided|95.0|-10.73|-1.64||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4|
1707012|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.52||||0.0606|2-Sided|95.0|-0.02|1.06|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 1|
1706867|NCT00883740|3140043|Superiority or Other||Mean Difference (Final Values)|-5.68||||0.2196|2-Sided|95.0|-14.81|3.44||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3|
1706868|NCT00883740|3140043|Superiority or Other||Mean Difference (Final Values)|-7.67||||0.0077|2-Sided|95.0|-13.27|-2.07||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2|
1706869|NCT00883740|3140043|Superiority or Other||Mean Difference (Final Values)|-7.66||||0.0001|2-Sided|95.0|-11.44|-3.89||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1|
1706870|NCT00883740|3140044|Superiority or Other||Mean Difference (Final Values)|0.89|||<|0.0001|2-Sided|95.0|0.51|1.26||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 4|
1706871|NCT00883740|3140044|Superiority or Other||Mean Difference (Final Values)|0.87|||<|0.0001|2-Sided|95.0|0.46|1.28||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 3|
1706872|NCT00883740|3140044|Superiority or Other||Mean Difference (Final Values)|1.14|||<|0.0001|2-Sided|95.0|0.76|1.53||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 2|
1706873|NCT00883740|3140044|Superiority or Other||Mean Difference (Final Values)|0.91|||<|0.0001|2-Sided|95.0|0.58|1.24||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 1|
1706874|NCT00883740|3140045|Superiority or Other||Mean Difference (Final Values)|-13.39||||0.0002|2-Sided|95.0|-20.36|-6.42||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 11|
1706875|NCT00883740|3140045|Superiority or Other||Mean Difference (Final Values)|-5.47||||0.1101|2-Sided|95.0|-12.2|1.26||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 5|
1706876|NCT00883740|3140046|Superiority or Other||Mean Difference (Final Values)|-18.81|||<|0.0001|2-Sided|95.0|-27.43|-10.2||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 11|
1706877|NCT00883740|3140046|Superiority or Other||Mean Difference (Final Values)|-8.13|||<|0.0591|2-Sided|95.0|-16.59|0.32||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Week 5|
1706878|NCT00883740|3140047|Superiority or Other||Mean Difference (Final Values)|2.14||||0.0024|2-Sided|95.0|0.78|3.5||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model||||
1706879|NCT00883740|3140048|Superiority or Other||Mean Difference (Final Values)|-5.44||||0.0199|2-Sided|95.0|-10.0|-0.88||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 4|
1706880|NCT00883740|3140048|Superiority or Other||Mean Difference (Final Values)|-6.83||||0.0004|2-Sided|95.0|-10.53|-3.13||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 3|
1706881|NCT00883740|3140048|Superiority or Other||Mean Difference (Final Values)|-6.0|||<|0.0001|2-Sided|95.0|-8.49|-3.51||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 2|
1706882|NCT00883740|3140048|Superiority or Other||Mean Difference (Final Values)|-1.25|||<|0.1106|2-Sided|95.0|-2.79|0.29||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Quarter 1|
1706883|NCT00883740|3140049|Superiority or Other||Mean Difference (Final Values)|-2.85||||0.0593|2-Sided|95.0|-5.82|0.11||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 8|
1706884|NCT00883740|3140049|Superiority or Other||Mean Difference (Final Values)|-2.59||||0.0366|2-Sided|95.0|-5.01|-0.16||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 7|
1706885|NCT00883740|3140049|Superiority or Other||Mean Difference (Final Values)|-3.89||||0.0024|2-Sided|95.0|-6.36|-1.41||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 6|
1706886|NCT00883740|3140049|Superiority or Other||Mean Difference (Final Values)|-3.01||||0.0065|2-Sided|95.0|-5.16|-0.86||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 5|
1707013|NCT00880399|3140461|Superiority or Other||Mean Difference (Net)|-0.48||||0.0275|2-Sided|95.0|-0.91|-0.05|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6|
1709138|NCT00852995|3144526|Superiority or Other|||||||0.029||||||Week 08|Cochran-Mantel-Haenszel||||
1706887|NCT00883740|3140049|Superiority or Other||Mean Difference (Final Values)|-3.52||||0.0002|2-Sided|95.0|-5.33|-1.71||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 4|
1706888|NCT00883740|3140049|Superiority or Other||Mean Difference (Final Values)|-2.44||||0.0009|2-Sided|95.0|-3.85|-1.03||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 3|
1706889|NCT00883740|3140049|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.0686|2-Sided|95.0|-2.29|0.09||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 2|
1706890|NCT00883740|3140049|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.3613|2-Sided|95.0|-1.07|0.39||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model|||Hour 1|
1706891|NCT00883740|3140050|Superiority or Other||Mean Difference (Final Values)|-7.18||||0.0447|2-Sided|95.0|-14.18|-0.17||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model||||
1706892|NCT00883740|3140051|Superiority or Other||Mean Difference (Final Values)|-1.53||||0.0008|2-Sided|95.0|-2.41|-0.66||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model||||
1706893|NCT00883740|3140052|Superiority or Other||Mean Difference (Final Values)|-2.41||||0.0135|2-Sided|95.0|-4.31|-0.51||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model||||
1706894|NCT00883740|3140053|Superiority or Other||Mean Difference (Final Values)|5.42|||<|0.0001|2-Sided|95.0|3.74|7.11||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model||||
1706895|NCT00883740|3140054|Superiority or Other||Mean Difference (Final Values)|25.54|||<|0.0001|2-Sided|95.0|17.48|33.61||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model||||
1706896|NCT00883740|3140055|Superiority or Other||Mean Difference (Final Values)|-1.81||||0.3841|2-Sided|95.0|-5.92|2.3||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model||||
1706897|NCT00883740|3140056|Superiority or Other||Mean Difference (Final Values)|-17.54|||<|0.0001|2-Sided|95.0|-23.29|-11.8||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model||||
1706898|NCT00883740|3140057|Superiority or Other||Mean Difference (Final Values)|-19.15|||<|0.0001|2-Sided|95.0|-26.69|-11.61||P-value is based on a linear mixed effects model including sequence, period, and treatment as fixed factors and participant within sequence and within participant error as random factors.|linear mixed effects model||||
1706899|NCT00883558|3140061|Non-Inferiority or Equivalence|Non-inferiority of INSULIN-PH20 NP to insulin lispro was supported if the upper limit of the one-sided 95% confidence interval for the difference in blood glucose between the treatments did not exceed 21.6 mg/dL.|LS Mean Difference|3.06||||0.3217|1-Sided|95.0||14.11|||Mixed Models Analysis|Adjustments included treatment, phase, and treatment sequence as fixed effects and participant within treatment sequence as a random effect.||A total of at least 40 participants were to be enrolled in the study, and 30 participants were expected to complete both treatment cycles. Assuming a standard deviation for blood glucose of 45 milligrams per deciliter (mg/dL) and a true difference between the treatments of 0 mg/dL, the study had approximately 80% power to show that INSULIN-PH20 NP was non-inferior to insulin lispro with respect to the overall two-hour postprandial blood glucose excursion.|
1706900|NCT00883337|3140080|Superiority or Other|||||||0.519||||||"Hochberg testing procedure:~a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons~a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value >0.05"|Log Rank|Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors||"Null hypothesis:~H1: No difference between Teriflunomide 14 mg and Rebif~H2: No difference between Teriflunomide 7 mg and Rebif"|
1706901|NCT00883337|3140080|Superiority or Other|||||||0.5953||||||"Hochberg testing procedure:~a-priori threshold for statistical significance ≤0.05 for the largest p-value of the 2 pair-wise comparisons~a-priori threshold for statistical significance ≤0.025 for the other p-value if the largest p-value >0.05"|Log Rank|Two-sided Log Rank test with the region of enrollment and baseline EDSS stratum as stratification factors||"The study was sized to detect a difference between Teriflunomide and Rebif groups in the time to failure at a significance level of 0.025 with a power of 81%.~Null hypothesis:~H1: No difference between Teriflunomide 14 mg and Rebif~H2: No difference between Teriflunomide 7 mg and Rebif"|
1706902|NCT00883129|3140145|Superiority or Other|||||||0.019||||||The threshold for statistical significance was a P-Value of </=0.05.|Log Rank|||A log-rank test was utilized to assess differences between the MMF and CYC treatment arms with respect to the time to withdrawal from study drug or meeting protocol-defined criteria for treatment failure.|
1706903|NCT00883129|3140146|Superiority or Other||||||<|0.05||||||The threshold for statistical significance was a P-Value of </=0.05.|Fisher Exact|The threshold for statistical significance was met only for the frequency of leukopenia and thrombocytopenia, but not for total SAE or death.||Fisher's Exact Test was utilized to compare the number of participants with a protocol-defined adverse event of interest, SAE or death between the MMF and CYC treatment arms.|
1707014|NCT00880399|3140461|Superiority or Other||Mean Difference (Net)|-0.31||||0.1362|2-Sided|95.0|-0.73|0.1|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6|
1706904|NCT00883129|3140147|Superiority or Other||||||>|0.05||||||The threshold for statistical significance was a P-Value of </=0.05.|Fisher Exact|||Based on the absolute difference between the value of the mRSS at baseline and at 24 months for each subject who returned for a 24-month assessment, a frequency distributions was prepared, stratified by treatment arm, to assess the relative distribution of subjects who either had improvements or worsening in the mRSS.|
1706905|NCT00883129|3140147|Superiority or Other||||||<|0.05||||||The threshold for statistical significance was a P-Value of </=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the modified Rodnan Skin Score for each treatment arm independently.|
1706906|NCT00883129|3140147|Superiority or Other||||||>|0.05||||||The threshold for statistical significance was a P-Value of </=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in modified Rodnan Skin Score (mRSS).|
1706907|NCT00883129|3140149|Superiority or Other||||||<|0.05||||||The threshold for statistical significance was a P-Value of </=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for dyspnea using the Transitional Dyspnea Index Score for each treatment arm independently.|
1706908|NCT00883129|3140149|Superiority or Other||||||>|0.05||||||The threshold for statistical significance was a P-Value of </=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in dyspnea as measured by the Transitional Dyspnea Index Score.|
1706909|NCT00883129|3140150|Superiority or Other||||||>|0.05||||||The threshold for statistical significance was a P-Value of </=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the Quantitative Lung Fibrosis Score for the whole lung (QLF-WL).|
1706910|NCT00883129|3140151|Superiority or Other||||||>|0.05||||||The threshold for statistical significance was a P-Value of </=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the DLCO %-predicted for each treatment arm independently.|
1706911|NCT00883129|3140151|Superiority or Other||||||<|0.001||||||The threshold for statistical significance was a P-Value of </=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the DLCO %-predicted.|
1706912|NCT00883129|3140152|Superiority or Other||||||>|0.05||||||The threshold for statistical significance was a P-Value of </=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the TLC %-predicted.|
1706913|NCT00883129|3140153|Superiority or Other|||||||0.55||||||The threshold for statistical significance was a P-Value of </=0.05.|Fisher Exact|||Based on the absolute difference between the value of FVC %-predicted at baseline and at 24 months for each subject who returned for a 24-month assessment, a frequency distributions was prepared, stratified by treatment arm, to assess the relative distribution of subjects who either had improvements or worsening in the FVC %-predicted.|
1706914|NCT00883129|3140153|Superiority or Other||||||<|0.05||||||The threshold for statistical significance was a P-Value of </=0.05.|Mixed Models Analysis|||The inferential joint model, as described for the primary analysis, was used to estimate the change from baseline to 24 months for the FVC %-predicted for each treatment arm independently.|
1706915|NCT00883129|3140153|Superiority or Other||||||<|0.24||||||The threshold for statistical significance was a P-Value of </=0.05.|Mixed Models Analysis|||A modified intention-to-treat inferential joint model combined a mixed-effects model for longitudinal outcomes and a survival model to handle non-ignorable missing data due to study dropout, treatment failure, or death, to assess the course over time, from baseline to 24 months, for the change in the FVC %-predicted. Covariates were %-predicted FVC, HRCT-defined extent of lung fibrosis in the lobe of maximum involvement, and terms for time-trend, treatment and treatment-time trend interactions.|
1706916|NCT00883116|3140156|Superiority or Other||Hazard Ratio (HR)|1.0||||0.8011|2-Sided|95.0|0.8|1.3|||Log Rank||||
1706917|NCT00883116|3140157|Superiority or Other||Hazard Ratio (HR)|1.3||||0.0397|2-Sided|95.0|1.0|1.7|||Log Rank||||
1706918|NCT00883103|3140158|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1706919|NCT00883051|3140187|Other|A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.|||||=|0|||||||Cochran-Armitage test for trend]||||
1706920|NCT00883051|3140188|Other|A hierarchical test procedure was applied only for analysis of the primary efficacy endpoint.|||||<|0.0001|||||||Cochran-Armitage test for trend||||
1706921|NCT00882921|3140206|Superiority or Other||Relative Risk|2.082||||0.2718|2-Sided|95.0|0.563|7.706|||Negative Binomial Model|||The groups compared are Ab+ (age adjusted) vs Ab- (age adjusted)|
1706922|NCT00882921|3140206|Superiority or Other||Relative Risk|2.873||||0.1309|2-Sided|95.0|0.731|11.296|||Negative Binomial Model|||The groups compared are Ab+ vs Ab-|
1706923|NCT00882908|3140220|Superiority or Other||Difference in proportions of SVRW72|18.9||||0.004|2-Sided|97.5|4.4|33.5|||Regression, Logistic||Difference in percentages of participants in the TMC435 150mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.|TMC/PR 150 mg 12 and 24 week treatment groups were pooled and the percentage of participants achieving SVRW72 was compared the percentage of participants achieving SVRW72 in the placebo treatment group.|
1707015|NCT00880399|3140461|Superiority or Other||Mean Difference (Net)|-0.29||||0.1311|2-Sided|95.0|-0.67|0.09|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4|
1706924|NCT00882908|3140220|Superiority or Other||Difference in proportions of SVRW72|13.0||||0.051|2-Sided|97.5|-1.9|28.0|||Regression, Logistic||Difference in percentages of participants in the TMC435 75mg and placebo groups with undetectable plasma Hepatitis C virus ribonucleic acid levels at end of treatment (EOT) and at Week 72 estimated from the logistic regression model.|TMC435 75 mg 12 and 24 week treatment groups were pooled and the percentage of participants acheiving SVRW72 were compared with the percentage of participants acheiving SVRW72 in the placebo treatment group.|
1706925|NCT00882687|3140270|Superiority or Other|||||||0.4326|||||||Wilcoxon rank-sum test||||
1706926|NCT00882687|3140270|Superiority or Other|||||||0.4222|||||||Wilcoxon rank-sum test||||
1706927|NCT00882687|3140270|Superiority or Other|||||||0.1773|||||||Wilcoxon rank-sum test||||
1706928|NCT00882687|3140271|Superiority or Other|||||||0.4709|||||||Wilcoxon rank-sum test||||
1706929|NCT00882687|3140271|Superiority or Other|||||||0.8988|||||||Wilcoxon rank-sum test||||
1706930|NCT00882687|3140271|Superiority or Other|||||||0.0578|||||||Wilcoxon rank-sum test||||
1706931|NCT00882687|3140272|Superiority or Other|||||||0.0404|||||||Wilcoxon rank-sum test||||
1706932|NCT00882687|3140272|Superiority or Other|||||||0.1493|||||||Wilcoxon rank-sum test||||
1706933|NCT00882687|3140272|Superiority or Other|||||||0.5846|||||||Wilcoxon rank-sum test||||
1706934|NCT00882687|3140273|Superiority or Other|||||||0.3324|||||||Wilcoxon rank-sum test||||
1706935|NCT00882687|3140273|Superiority or Other|||||||0.9144|||||||Wilcoxon rank-sum test||||
1706936|NCT00882687|3140273|Superiority or Other|||||||0.3235|||||||Wilcoxon rank-sum test||||
1706937|NCT00882115|3140310|Other||||||<|0.01|||||||ANOVA|Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.||Comparison waws made to the 6 hour minus baseline change in both control phase and intervention phase.|
1706938|NCT00882115|3140310|Other||||||<|0.001|||||||ANOVA|Data followed the normal distribution, therefore, a parametric repeated measure (mixed model) ANOVA model was used to compare means.||Comparison was made to the 24 h minus baseline change in both control phase and intervention phase.|
1706939|NCT00881894|3140323|Non-Inferiority or Equivalence|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9896||||||90.0|0.9179|1.0671||||||Bioequivalence testing by using the 90% Confidence Interval (CI).|
1706940|NCT00881894|3140324|Non-Inferiority or Equivalence|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9584||||||90.0|0.8861|1.0367|||||Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).|
1706941|NCT00881894|3140325|Non-Inferiority or Equivalence|If the 90% Confidence Interval for the ratio of geometric LS- Means is included within 0.8- 1.25, the patches are considered bioequivalent.|ratio of geometric LS- Means|0.9864||||||90.0|0.9103|1.0688|||||Bioequivalence is concluded if the 90% CIs for the ratio Treatment A/ Treatment B are fully included in the acceptance range from 0.8- 1.25 for AUC(0-tz) and Cmax.|Bioequivalence testing by using the 90% Confidence Interval (CI).|
1706942|NCT00881361|3140364|Superiority|||||||0.003|||||||t-test, 2 sided||||
1706943|NCT00880919|3140388|Superiority or Other|||||||0.015|||||||ANOVA|||Mean changes were calculated using each groups linear and quadratic effects|
1706944|NCT00880763|3140415|Superiority or Other||Difference in least squares mean|-1.6|||||2-Sided|95.0|-2.2|-1.1|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.||
1706945|NCT00880763|3140415|Superiority or Other||Difference in least squares mean|-1.9|||||2-Sided|95.0|-2.4|-1.3|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.||
1706946|NCT00880763|3140415|Superiority or Other||Difference in least squares mean|-1.8|||||2-Sided|95.0|-2.3|-1.2|||||Computed using a longitudinal data analysis model including treatment, time and the interaction of time by treatment, with a restriction of the same baseline mean across treatment groups.||
1706947|NCT00880763|3140416|Superiority or Other||Adjusted difference in percent|14.4|||||2-Sided|95.0|-3.3|36.1|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)||
1706948|NCT00880763|3140416|Superiority or Other||Adjusted difference in percent|14.6|||||2-Sided|95.0|-3.4|36.3|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)||
1706949|NCT00880763|3140416|Superiority or Other||Adjusted difference in percent|14.5|||||2-Sided|95.0|-2.5|36.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)||
1706950|NCT00880763|3140417|Superiority or Other||Adjusted difference in percent|4.8|||||2-Sided|95.0|-12.0|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)||
1706951|NCT00880763|3140417|Superiority or Other||Adjusted difference in percent|4.9|||||2-Sided|95.0|-12.4|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)||
1706952|NCT00880763|3140417|Superiority or Other||Adjusted difference in percent|4.8|||||2-Sided|95.0|-11.3|24.2|||||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not)||
1706953|NCT00880763|3140418|Superiority or Other||Adjusted difference in percent|55.4|||<|0.001|2-Sided|95.0|24.9|76.0|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).||
1706954|NCT00880763|3140418|Superiority or Other||Adjusted difference in percent|74.5|||<|0.001|2-Sided|95.0|47.6|89.0|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).||
1706955|NCT00880763|3140418|Superiority or Other||Adjusted difference in percent|65.1|||<|0.001|2-Sided|95.0|37.0|82.8|||Miettinen and Nurminen||Computed using Miettinen and Nurminen method adjusting the strata (participation of Intensive-pharmacokinetic cohort vs. not).||
1706957|NCT00880750|3140420|Superiority or Other||Ratio of geometric LS means|1.26||||||90.0|1.2|1.33||||||The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.|
1706958|NCT00880750|3140421|Superiority or Other||Ratio of geometric LS means|1.34||||||90.0|1.26|1.42||||||The LS means and associated SEs for granules and tablets as well as the difference between granules and tablets were determined. From the LS mean and SE of the difference, a 90% CI was constructed for the difference of the logs of granules and tablets. An exponential transformation was applied to the lower and upper limits of the CI. This created a point estimate and 90% CI for the ratio of LS means for granules to tablets.|
1706959|NCT00880750|3140422|Non-Inferiority or Equivalence|A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.40, 3.40).|Mean Difference (Final Values)|-1.98|||||2-Sided|90.0|-3.17|-0.8|||||||
1706960|NCT00880750|3140423|Non-Inferiority or Equivalence|A standard 90% confidence interval (CI) was constructed for the difference in least square means of the primary pharmacodynamic (PD) variable between the granules formulation and the reference chewable tablet formulation. A critical reference representing +/- 20% of the reference chewable tablet formulation least squares mean was constructed. PD equivalence was to be claimed if the 90% CI was completely contained within the critical reference range of (-3.47, 3.47).|Mean Difference (Final Values)|-1.35|||||2-Sided|90.0|-2.18|-0.51|||||||
1706961|NCT00880698|3140429|Superiority or Other||Risk Difference (RD)|65.1|||<|0.001|2-Sided|95.0|42.7|81.7||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for IgA in RotaTeq group minus Placebo group.|IgA|
1706962|NCT00880698|3140429|Superiority or Other||Risk Difference (RD)|51.4|||<|0.001|2-Sided|95.0|34.3|66.3||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for IgA in RotaTeq group minus Placebo group.|IgA|
1706963|NCT00880698|3140429|Superiority or Other||Risk Difference (RD)|11.7|||<|0.34|2-Sided|95.0|-12.0|35.5||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA P1 in RotaTeq group minus Placebo group.|SNA P1|
1706964|NCT00880698|3140429|Superiority or Other||Risk Difference (RD)|16.4|||<|0.024|2-Sided|95.0|-1.7|34.2||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA P1 in RotaTeq group minus Placebo group.|SNA P1|
1706965|NCT00880698|3140429|Superiority or Other||Risk Difference (RD)|58.6|||<|0.001|2-Sided|95.0|37.2|75.9||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G4 in RotaTeq group minus Placebo group.|SNA G4|
1706966|NCT00880698|3140429|Superiority or Other||Risk Difference (RD)|26.4|||<|0.001|2-Sided|95.0|8.0|42.9||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G4 in RotaTeq group minus Placebo group.|SNA G4|
1706967|NCT00880698|3140429|Superiority or Other||Risk Difference (RD)|29.4|||<|0.001|2-Sided|95.0|4.7|50.6||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G3 in RotaTeq group minus Placebo group.|SNA G3|
1706968|NCT00880698|3140429|Superiority or Other||Risk Difference (RD)|19.3|||<|0.001|2-Sided|95.0|0.9|36.4||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G3 in RotaTeq group minus Placebo group.|SNA G3|
1706969|NCT00880698|3140429|Superiority or Other||Risk Difference (RD)|14.2|||<|0.19|2-Sided|95.0|-10.6|36.7||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G2 in RotaTeq group minus Placebo group.|SNA G2|
1706970|NCT00880698|3140429|Superiority or Other||Risk Difference (RD)|7.1|||<|0.2|2-Sided|95.0|-11.3|24.8||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G2 in RotaTeq group minus Placebo group.|SNA G2|
1706971|NCT00880698|3140429|Superiority or Other||Risk Difference (RD)|49.8|||<|0.001|2-Sided|95.0|27.1|68.6||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 infected participants classified as responders for SNA G1 in RotaTeq group minus Placebo group.|SNA G1|
1706972|NCT00880698|3140429|Superiority or Other||Risk Difference (RD)|29.9|||<|0.001|2-Sided|95.0|11.5|46.1||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference (95% confidence interval) in percentage of HIV-1 uninfected participants classified as responders for SNA G1 in RotaTeq group minus Placebo group.|SNA G1|
1706973|NCT00880698|3140430|Superiority or Other||Risk Difference (RD)|0.7||||1|2-Sided|95.0|-21.0|23.4||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference and 95% confidence interval (RotaTeq minus Placebo) in percentage of HIV-infected participants experiencing a new grade >=3 adverse event||
1709139|NCT00852995|3144526|Superiority or Other|||||||0.014||||||Week 07|Cochran-Mantel-Haenszel||||
1706974|NCT00880698|3140430|Superiority or Other||Risk Difference (RD)|-3.1||||0.62|2-Sided|95.0|-20.6|14.8||The pre-specified significance level was 5%. No adjustments were made for multiple comparisons.|Fisher Exact||Difference and 95% confidence interval (RotaTeq minus Placebo) in percentage of HIV-uninfected participants experiencing a new grade >=3 adverse event||
1706975|NCT00880607|3140436|Other|||||||0.31|||||||Chi-squared||||
1706976|NCT00880607|3140437|Other|||||||0.07|||||||Chi-squared||||
1706977|NCT00880607|3140438|Other|||||||0.3|||||||Chi-squared||||
1706978|NCT00880607|3140439|Other|||||||0.08|||||||Chi-squared||||
1706979|NCT00880607|3140441|Other|Log-rank test in Kaplan-Meier used.||||||0.42|||||||Log Rank||||
1706980|NCT00880607|3140442|Other|Wilcoxon rank-sum test because the outcome variable was found to have a skewed distribution.|Median Difference (Final Values)|7.7||||0.27|2-Sided|95.0|-5.8|21.2||Hodges-Lehmanne estimation method|Wilcoxon (Mann-Whitney)||Hodges-Lehmanne estimation method||
1706981|NCT00880399|3140455|Superiority or Other||Mean Difference (Net)|-2.26||||0.0234|2-Sided|95.0|-4.22|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6|
1706982|NCT00880399|3140455|Superiority or Other||Mean Difference (Net)|-0.36||||0.714|2-Sided|95.0|-2.3|1.58|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6|
1706983|NCT00880399|3140455|Superiority or Other||Mean Difference (Net)|-0.58||||0.5206|2-Sided|95.0|-2.36|1.2|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4|
1706984|NCT00880399|3140455|Superiority or Other||Mean Difference (Net)|0.07||||0.9403|2-Sided|95.0|-1.71|1.85|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4|
1706985|NCT00880399|3140455|Superiority or Other||Mean Difference (Net)|0.6||||0.4106|2-Sided|95.0|-0.84|2.05|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2|
1706986|NCT00880399|3140455|Superiority or Other||Mean Difference (Net)|-0.17||||0.8195|2-Sided|95.0|-1.61|1.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2|
1706987|NCT00880399|3140455|Superiority or Other||Mean Difference (Net)|0.08||||0.894|2-Sided|95.0|-1.17|1.34|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1|
1706988|NCT00880399|3140455|Superiority or Other||Mean Difference (Net)|0.0||||0.9951|2-Sided|95.0|-1.26|1.25|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1|
1706989|NCT00880399|3140456|Superiority or Other||Mean Difference (Net)|0.64||||0.6766|2-Sided|95.0|-2.42|3.71|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6|
1706990|NCT00880399|3140456|Superiority or Other||Mean Difference (Net)|1.21||||0.4192|2-Sided|95.0|-1.76|4.19|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6|
1706991|NCT00880399|3140456|Superiority or Other||Mean Difference (Net)|0.75||||0.5984|2-Sided|95.0|-2.08|3.59|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4|
1706992|NCT00880399|3140456|Superiority or Other||Mean Difference (Net)|1.48||||0.285|2-Sided|95.0|-1.26|4.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4|
1706993|NCT00880399|3140456|Superiority or Other||Mean Difference (Net)|1.01||||0.4642|2-Sided|95.0|-1.73|3.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2|
1706994|NCT00880399|3140456|Superiority or Other||Mean Difference (Net)|1.05||||0.4327|2-Sided|95.0|-1.6|3.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2|
1706995|NCT00880399|3140456|Superiority or Other||Mean Difference (Net)|1.35||||0.2905|2-Sided|95.0|-1.17|3.86|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1|
1706996|NCT00880399|3140456|Superiority or Other||Mean Difference (Net)|2.2||||0.0735|2-Sided|95.0|-0.21|4.61|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1|
1706997|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.74||||0.0296|2-Sided|95.0|0.07|1.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 6|
1706998|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.65||||0.0562|2-Sided|95.0|-0.02|1.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 6|
1706999|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.77||||0.0141|2-Sided|95.0|0.16|1.39|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 4|
1707000|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|-0.03||||0.9305|2-Sided|95.0|-0.64|0.58|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 4|
1707001|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.58||||0.0418|2-Sided|95.0|0.02|1.15|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 2|
1707002|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.6||||0.0361||95.0|0.04|1.16|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 2|
1707003|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.7||||0.0108|2-Sided|95.0|0.16|1.24|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, RVS at Week 1|
1707004|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.39||||0.1484|2-Sided|95.0|-0.14|0.92|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, RVS at Week 1|
1707005|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.77||||0.0181|2-Sided|95.0|0.13|1.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 6|
1707006|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.66||||0.044|2-Sided|95.0|0.02|1.3|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 6|
1707007|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.82||||0.0078|2-Sided|95.0|0.22|1.42|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 4|
1707008|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.13||||0.6692|2-Sided|95.0|-0.47|0.72|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 4|
1707009|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.84||||0.0034|2-Sided|95.0|0.28|1.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 2|
1707010|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.94||||0.001|2-Sided|95.0|0.38|1.5|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SQ at Week 2|
1707011|NCT00880399|3140460|Superiority or Other||Mean Difference (Net)|0.69||||0.0132|2-Sided|95.0|0.15|1.24|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SQ at Week 1|
1707016|NCT00880399|3140461|Superiority or Other||Mean Difference (Net)|0.01||||0.9663|2-Sided|95.0|-0.36|0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4|
1707017|NCT00880399|3140461|Superiority or Other||Mean Difference (Net)|-0.25||||0.1389|2-Sided|95.0|-0.57|0.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2|
1707018|NCT00880399|3140461|Superiority or Other||Mean Difference (Net)|-0.11||||0.5022|2-Sided|95.0|-0.44|0.21|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2|
1707019|NCT00880399|3140461|Superiority or Other||Mean Difference (Net)|0.16||||0.6179|2-Sided|95.0|-0.47|0.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1|
1707020|NCT00880399|3140461|Superiority or Other||Mean Difference (Net)|-0.22||||0.4814|2-Sided|95.0|-0.83|0.39|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1|
1707021|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|2.9||||0.8497|2-Sided|95.0|-27.33|33.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 6|
1707022|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|-4.09||||0.7844|2-Sided|95.0|-33.55|25.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 6|
1707023|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|-1.67||||0.9132|2-Sided|95.0|-31.87|28.53|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 4|
1707024|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|2.15||||0.8861|2-Sided|95.0|-27.45|31.76|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 4|
1707025|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|-22.25||||0.0313|2-Sided|95.0|-42.49|-2.01|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 2|
1707026|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|-15.86||||0.122|2-Sided|95.0|-36.0|4.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 2|
1707027|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|-9.3||||0.3564|2-Sided|95.0|-29.11|10.52|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, WTSO at Week 1|
1707028|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|2.4||||0.8071|2-Sided|95.0|-16.95|21.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, WTSO at Week 1|
1707029|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|-3.25||||0.6471|2-Sided|95.0|-17.19|10.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 6|
1707030|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|6.84||||0.3345|2-Sided|95.0|-7.09|20.78|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 6|
1707031|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|-15.31||||0.0784|2-Sided|95.0|-32.37|1.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 4|
1707032|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|-10.71||||0.2157|2-Sided|95.0|-27.7|6.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 4|
1707033|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|-24.67||||0.0015|2-Sided|95.0|-39.86|-9.49|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 2|
1707034|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|-7.67||||0.3206|2-Sided|95.0|-22.85|7.5|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 2|
1707035|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|-23.9||||0.0026|2-Sided|95.0|-39.4|-8.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, SOL at Week 1|
1707036|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|-11.52||||0.1397|2-Sided|95.0|-26.83|3.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, SOL at Week 1|
1707037|NCT00880399|3140462|Superiority or Other||Mean Difference (Final Values)|11.47||||0.3974|2-Sided|95.0|-15.19|38.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 6|
1707038|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|4.48||||0.7412||95.0|-22.21|31.16|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 6|
1707039|NCT00880399|3140462|Superiority or Other||Median Difference (Net)|21.11||||0.1606|2-Sided|95.0|-8.43|50.64|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 4|
1707040|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|-17.51||||0.2419|2-Sided|95.0|-46.9|11.89|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 4|
1707041|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|13.52||||0.3127|2-Sided|95.0|-12.8|39.85|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 2|
1707042|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|8.12||||0.5439|2-Sided|95.0|-18.18|34.41|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 2|
1707043|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|27.36||||0.0332|2-Sided|95.0|2.2|52.52|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg, TST at Week 1|
1707044|NCT00880399|3140462|Superiority or Other||Mean Difference (Net)|4.45||||0.7246|2-Sided|95.0|-20.38|29.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg, TST at Week 1|
1707045|NCT00880399|3140463|Superiority or Other||Mean Difference (Net)|-2.34||||0.0202|2-Sided|95.0|-4.31|-0.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6|
1707046|NCT00880399|3140463|Superiority or Other||Mean Difference (Net)|-2.16||||0.0312|2-Sided|95.0|-4.12|-0.2|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6|
1707047|NCT00880399|3140463|Superiority or Other||Mean Difference (Net)|-1.15||||0.2048|2-Sided|95.0|-2.93|0.63|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4|
1707048|NCT00880399|3140463|Superiority or Other||Mean Difference (Net)|-1.22||||0.1757|2-Sided|95.0|-2.98|0.55|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4|
1707049|NCT00880399|3140463|Superiority or Other||Mean Difference (Net)|-0.56||||0.468|2-Sided|95.0|-2.09|0.96|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2|
1707050|NCT00880399|3140463|Superiority or Other||Mean Difference (Net)|-1.51||||0.0515|2-Sided|95.0|-3.03|0.01|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2|
1707051|NCT00880399|3140463|Superiority or Other||Mean Difference (Net)|0.02||||0.9814|2-Sided|95.0|-1.56|1.6|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1|
1707052|NCT00880399|3140463|Superiority or Other||Mean Difference (Net)|-0.48||||0.5473|2-Sided|95.0|-2.04|1.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1|
1707053|NCT00880399|3140464|Superiority or Other||Mean Difference (Net)|-0.49||||0.0059|2-Sided|95.0|-0.83|-0.14|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6|
1707054|NCT00880399|3140464|Superiority or Other||Mean Difference (Net)|-0.45||||0.0099|2-Sided|95.0|-0.79|-0.11|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6|
1707055|NCT00880399|3140464|Superiority or Other||Mean Difference (Net)|-0.46||||0.0014|2-Sided|95.0|-0.75|-0.18|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4|
1707056|NCT00880399|3140464|Superiority or Other||Mean Difference (Net)|-0.34||||0.0166|2-Sided|95.0|-0.62|-0.06|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4|
1707057|NCT00880399|3140464|Superiority or Other||Mean Difference (Net)|-0.22||||0.0348|2-Sided|95.0|-0.43|-0.02|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2|
1707058|NCT00880399|3140464|Superiority or Other||Mean Difference (Net)|-0.37||||0.0004|2-Sided|95.0|-0.58|-0.17|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2|
1707059|NCT00880399|3140464|Superiority or Other||Mean Difference (Net)|-0.09||||0.2639|2-Sided|95.0|-0.25|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1|
1707060|NCT00880399|3140464|Superiority or Other||Mean Difference (Net)|-0.09||||0.2523|2-Sided|95.0|-0.25|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1|
1707061|NCT00880399|3140465|Superiority or Other||Adjusted Odds Ratio|1.53||||0.2007|2-Sided|95.0|0.8|2.92|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 6|
1707062|NCT00880399|3140465|Superiority or Other||Adjusted Odds Ratio|1.77||||0.0806|2-Sided|95.0|0.93|3.37|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 6|
1707063|NCT00880399|3140465|Superiority or Other||Adjusted Odds Ratio|1.65||||0.1413|2-Sided|95.0|0.85|3.23|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 4|
1707064|NCT00880399|3140465|Superiority or Other||Adjusted Odds Ratio|1.87||||0.063|2-Sided|95.0|0.97|3.61|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 4|
1707065|NCT00880399|3140465|Superiority or Other||Adjusted Odds Ratio|1.8||||0.1862|2-Sided|95.0|0.75|4.3|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 2|
1707066|NCT00880399|3140465|Superiority or Other||Adjusted Odds Ratio|2.6||||0.0247|2-Sided|95.0|1.13|5.98|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 2|
1707067|NCT00880399|3140465|Superiority or Other||Adjusted Odds Ratio|0.77||||0.7084|2-Sided|95.0|0.2|2.97|||Regression, Logistic|||Placebo Vs Orvepitant 60 mg at Week 1|
1707068|NCT00880399|3140465|Superiority or Other||Adjusted Odds Ratio|2.14||||0.1731|2-Sided|95.0|0.72|6.4|||Regression, Logistic|||Placebo Vs Orvepitant 30 mg at Week 1|
1707069|NCT00880399|3140466|Superiority or Other||Mean Difference (Net)|-0.7||||0.0498|2-Sided|95.0|-1.4|0.0|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6|
1707070|NCT00880399|3140466|Superiority or Other||Mean Difference (Net)|-0.45||||0.195|2-Sided|95.0|-1.14|0.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6|
1707071|NCT00880399|3140466|Superiority or Other||Mean Difference (Net)|-0.59||||0.0587|2-Sided|95.0|-1.2|0.02|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4|
1707072|NCT00880399|3140466|Superiority or Other||Mean Difference (Net)|-0.32||||0.2937|2-Sided|95.0|-0.93|0.28|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4|
1707073|NCT00880399|3140466|Superiority or Other||Mean Difference (Net)|-0.44||||0.0928|2-Sided|95.0|-0.95|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2|
1707074|NCT00880399|3140466|Superiority or Other||Mean Difference (Net)|-0.44||||0.0898|2-Sided|95.0|-0.94|0.07|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2|
1707075|NCT00880399|3140466|Superiority or Other||Mean Difference (Net)|-0.21||||0.3476|2-Sided|95.0|-0.66|0.23|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1|
1707076|NCT00880399|3140466|Superiority or Other||Mean Difference (Net)|0.0||||0.9854|2-Sided|95.0|-0.45|0.44|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1|
1707077|NCT00880399|3140467|Superiority or Other||Mean Difference (Net)|-1.68||||0.0282|2-Sided|95.0|-3.17|-0.18|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6|
1707078|NCT00880399|3140467|Superiority or Other||Mean Difference (Net)|-1.29||||0.088|2-Sided|95.0|-2.78|0.19|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6|
1707079|NCT00880399|3140467|Superiority or Other||Mean Difference (Net)|-2.1||||0.0017|2-Sided|95.0|-3.4|-0.79|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4|
1707080|NCT00880399|3140467|Superiority or Other||Mean Difference (Net)|-1.69||||0.0107|2-Sided|95.0|-2.99|-0.4|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4|
1707081|NCT00880399|3140467|Superiority or Other||Mean Difference (Net)|-0.55||||0.3498|2-Sided|95.0|-1.71|0.61|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2|
1707082|NCT00880399|3140467|Superiority or Other||Mean Difference (Net)|-1.02||||0.082|2-Sided|95.0|-2.17|0.13|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2|
1707083|NCT00880399|3140467|Superiority or Other||Mean Difference (Net)|-0.66||||0.2116|2-Sided|95.0|-1.69|0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1|
1707084|NCT00880399|3140467|Superiority or Other||Mean Difference (Net)|-0.72||||0.1662|2-Sided|95.0|-1.74|0.3|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1|
1707085|NCT00880399|3140468|Superiority or Other||Mean Difference (Net)|-1.54||||0.0092||95.0|-2.69|-0.38|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 6|
1707086|NCT00880399|3140468|Superiority or Other||Mean Difference (Net)|-1.22||||0.0361|2-Sided|95.0|-2.37|-0.08|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 6|
1707087|NCT00880399|3140468|Superiority or Other||Mean Difference (Net)|-1.68||||0.001|2-Sided|95.0|-2.67|-0.69|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 4|
1707088|NCT00880399|3140468|Superiority or Other||Mean Difference (Net)|-1.29||||0.0104|2-Sided|95.0|-2.27|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 4|
1707089|NCT00880399|3140468|Superiority or Other||Mean Difference (Net)|-0.91||||0.023|2-Sided|95.0|-1.69|-0.13|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 2|
1707090|NCT00880399|3140468|Superiority or Other||Mean Difference (Net)|-1.04||||0.0092|2-Sided|95.0|-1.82|-0.26|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 2|
1707091|NCT00880399|3140468|Superiority or Other||Median Difference (Final Values)|-0.15||||0.6429|2-Sided|95.0|-0.79|0.49|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 60 mg at Week 1|
1707092|NCT00880399|3140468|Superiority or Other||Mean Difference (Net)|-0.09||||0.7859|2-Sided|95.0|-0.72|0.55|||Mixed Models Repeated Measures|||Placebo Vs Orvepitant 30 mg at Week 1|
1707093|NCT00880399|3140469|Superiority or Other||Hazard Ratio (HR)|1.66||||0.37|2-Sided|95.0|0.84|3.3|||Log Rank|||Placebo Vs Orvepitant 60 mg at Week 6|
1707094|NCT00880399|3140469|Superiority or Other||Hazard Ratio (HR)|1.6||||0.51|2-Sided|95.0|0.8|3.19|||Log Rank|||Placebo Vs Orvepitant 30 mg at Week 6|
1707095|NCT00880399|3140471|Superiority or Other||Mean Difference (Net)|-2.86||||0.0082|2-Sided|95.0|-4.97|-0.75|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 6|
1707096|NCT00880399|3140471|Superiority or Other||Mean Difference (Net)|-2.41||||0.0245|2-Sided|95.0|-4.5|-0.31|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 6|
1707097|NCT00880399|3140471|Superiority or Other||Mean Difference (Net)|-3.06||||0.001|2-Sided|95.0|-4.86|-1.25|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 4|
1707098|NCT00880399|3140471|Superiority or Other||Mean Difference (Net)|-2.22||||0.0152|2-Sided|95.0|-4.0|-0.43|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 4|
1707099|NCT00880399|3140471|Superiority or Other||Mean Difference (Net)|-1.84||||0.0141|2-Sided|95.0|-3.3|-0.37|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 2|
1707100|NCT00880399|3140471|Superiority or Other||Mean Difference (Net)|-1.89||||0.0111|2-Sided|95.0|-3.34|-0.43|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 2|
1707101|NCT00880399|3140471|Superiority or Other||Mean Difference (Net)|-1.15||||0.0586|2-Sided|95.0|-2.34|0.04|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 60 mg at Week 1|
1707102|NCT00880399|3140471|Superiority or Other||Mean Difference (Net)|-0.47||||0.4295|2-Sided|95.0|-1.65|0.7|||Mixed Models Repeated Measures|||Placebo Vs Orvepitatnt 30 mg at Week 1|
1707103|NCT00880334|3140474|Superiority or Other|||||||0.31|||||||Fisher Exact||||
1707104|NCT00880334|3140475|Superiority or Other|||||||0.56|||||||Fisher Exact||||
1707105|NCT00880334|3140476|Superiority or Other||Hazard Ratio (HR)|1.21||||0.873|2-Sided|95.0|0.81|1.79|||Log Rank||||
1707106|NCT00880334|3140478|Superiority or Other||Hazard Ratio (HR)|1.02||||0.939|2-Sided|95.0|0.69|1.49|||Log Rank|||The study was designed with 80% power to detect 60% improvement in median PFS from 18 to 28.8 weeks (Vandetanib+docetaxel/Placebo+docetaxel hazard ratio of 0.625) with the addition of Vandetanib while maintaining an overall significance level of 5% in a one-sided test. This assumed exponential distribution of events, accrual of 1.75 patients per week (7-8 patients per month) for 78 weeks with 34 weeks of additional follow-up (112 weeks total). Full information was 118 PFS events.|
1707107|NCT00880191|3140509|Superiority or Other|||||||0.3694|||||||Fisher Exact|||The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale, and no rescue agents.|
1707108|NCT00880191|3140510|Superiority or Other|||||||0.2344|||||||Fisher Exact|||Complete Responders by Arm - Days 2-6, the primary analysis utilizes Fisher’s exact test to compare the percentage of complete responders in each group (dex/gabapentin vs. dex/placebo), with complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder.|
1707109|NCT00880087|3140523|Superiority|||||||0.46|||||||Wilcoxon (Mann-Whitney)|"Test used the continuous (NOT categorized as reported above) neuropsychological scores, with Lowest Possible Score treated as lowest possible value."|||
1707110|NCT00880087|3140524|Superiority|||||||0.7|||||||Stratified Mann-Whitney Test|Test stratified by age category (<2 years, 2 to <12 years, or >=12 years), for continuous (NOT categorized as reported above) 1-year change in VABS-II|||As the (nonparametric) comparison treated 1-year deaths as worst possible outcomes and worst possible 1-year VABS-II as next worst possible outcomes, using change in VABS-II for other participants alive at 1 year, no relevant estimation of effect size is possible for this secondary outcome.
1707111|NCT00880087|3140525|Superiority||Risk Difference (RD)|2.8||||0.56|2-Sided|95.0|-8.0|13.7|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (<2 years, 2 to <12 years, or >=12 years)|||
1707112|NCT00880087|3140526|Superiority||Risk Difference (RD)|-2.6||||0.63|2-Sided|95.0|-14.5|9.2|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (<2 years, 2 to <12 years, or >=12 years)|||
1707113|NCT00880048|3140527|Superiority||Mean Difference (Net)|0.71||||0.4753|2-Sided|95.0|-1.24|2.66|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6|
1707114|NCT00880048|3140527|Superiority||Mean Difference (Net)|-0.55||||0.5796|2-Sided|95.0|-2.49|1.4|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6|
1707115|NCT00880048|3140527|Superiority||Mean Difference (Net)|0.06||||0.9434|2-Sided|95.0|-1.7|1.83|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4|
1707116|NCT00880048|3140527|Superiority||Mean Difference (Net)|-0.98||||0.2768|2-Sided|95.0|-2.75|0.79|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4|
1707117|NCT00880048|3140527|Superiority||Mean Difference (Net)|0.94||||0.241|2-Sided|95.0|-0.63|2.51|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2|
1707118|NCT00880048|3140527|Superiority||Mean Difference (Net)|-0.76||||0.3382|2-Sided|95.0|-2.33|0.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2|
1707119|NCT00880048|3140527|Superiority||Mean Difference (Net)|0.47||||0.4644|2-Sided|95.0|-0.79|1.73|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1|
1707120|NCT00880048|3140527|Superiority||Mean Difference (Net)|-0.97||||0.1301|2-Sided|95.0|-2.24|0.29|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1|
1707121|NCT00880048|3140528|Superiority||Odds Ratio (OR)|-0.67||||0.7026|2-Sided|95.0|-4.14|2.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6|
1707122|NCT00880048|3140528|Superiority||Mean Difference (Net)|-0.68||||0.6911|2-Sided|95.0|-4.06|2.7|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6|
1707123|NCT00880048|3140528|Superiority||Mean Difference (Net)|-0.71||||0.6428|2-Sided|95.0|-3.74|2.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4|
1707124|NCT00880048|3140528|Superiority||Mean Difference (Net)|0.19||||0.9008|2-Sided|95.0|-2.8|3.18|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4|
1707125|NCT00880048|3140528|Superiority||Mean Difference (Net)|0.92||||0.4828|2-Sided|95.0|-1.67|3.5|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2|
1707126|NCT00880048|3140528|Superiority||Mean Difference (Net)|2.44||||0.0594|2-Sided|95.0|-0.1|4.99|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2|
1707127|NCT00880048|3140528|Superiority||Mean Difference (Net)|-0.56||||0.602|2-Sided|95.0|-2.66|1.55|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1|
1707128|NCT00880048|3140528|Superiority||Mean Difference (Net)|1.03||||0.3241|2-Sided|95.0|-1.03|3.1|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1|
1707129|NCT00880048|3140531|Superiority||Odds Ratio (OR)|1.38||||0.4962|2-Sided|95.0|0.55|3.45|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 6|
1707130|NCT00880048|3140531|Superiority||Odds Ratio (OR)|2.3||||0.0507|2-Sided|95.0|1.0|5.32|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 6|
1707131|NCT00880048|3140531|Superiority||Odds Ratio (OR)|2.8||||0.0455|2-Sided|95.0|1.02|7.68|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 4|
1707132|NCT00880048|3140531|Superiority||Odds Ratio (OR)|2.35||||0.1009|2-Sided|95.0|0.85|6.49|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 4|
1707133|NCT00880048|3140531|Superiority||Odds Ratio (OR)|2.0||||0.355|2-Sided|95.0|0.46|8.63|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 2|
1707134|NCT00880048|3140531|Superiority||Odds Ratio (OR)|1.0||||0.9967|2-Sided|95.0|0.2|5.07|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 2|
1707135|NCT00880048|3140531|Superiority||Odds Ratio (OR)|0.54||||0.6227|2-Sided|95.0|0.05|6.13|||Regression, Logistic|||Placebo vs GW823296 60 mg: Week 1|
1707136|NCT00880048|3140531|Superiority||Odds Ratio (OR)|0.98||||0.9824|2-Sided|95.0|0.13|7.09|||Regression, Logistic|||Placebo vs GW823296 30 mg: Week 1|
1707137|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.71||||0.0472|2-Sided|95.0|0.01|1.41|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, refreshing value of sleep|
1707138|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.37||||0.2874|2-Sided|95.0|-0.31|1.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, refreshing value of sleep|
1707139|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.39||||0.2129|2-Sided|95.0|-0.22|1.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, refreshing value of sleep|
1707140|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.69||||0.0271|2-Sided|95.0|0.08|1.29|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, refreshing value of sleep|
1707141|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.65||||0.0247|2-Sided|95.0|0.08|1.22|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, refreshing value of sleep|
1707142|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.33||||0.2404|2-Sided|95.0|-0.22|0.89|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, refreshing value of sleep|
1707143|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.63||||0.0233|2-Sided|95.0|0.09|1.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, refreshing value of sleep|
1707144|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.34||||0.2147|2-Sided|95.0|-0.2|0.88|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, refreshing value of sleep|
1707145|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.32||||0.3503|2-Sided|95.0|-0.35|1.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, sleep quality|
1707146|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.56||||0.0956|2-Sided|95.0|-0.1|1.23|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, sleep quality|
1707147|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.42||||0.1675|2-Sided|95.0|-0.18|1.02|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, sleep quality|
1707148|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.73||||0.017|2-Sided|95.0|0.13|1.33|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, sleep quality|
1707149|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.5||||0.0873|2-Sided|95.0|-0.07|1.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, sleep quality|
1707150|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.42||||0.1443|2-Sided|95.0|-0.15|0.99|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, sleep quality|
1707151|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.72||||0.0111|2-Sided|95.0|0.17|1.27|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, sleep quality|
1707152|NCT00880048|3140532|Superiority||Mean Difference (Net)|0.59||||0.0344|2-Sided|95.0|0.04|1.14|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, sleep quality|
1707153|NCT00880048|3140533|Superiority||Mean Difference (Net)|-0.24||||0.2993|2-Sided|95.0|-0.7|0.22|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6|
1707154|NCT00880048|3140533|Superiority||Mean Difference (Net)|0.2||||0.3709|2-Sided|95.0|-0.24|0.64|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6|
1707155|NCT00880048|3140533|Superiority||Mean Difference (Net)|-0.4||||0.1259|2-Sided|95.0|-0.91|0.11|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4|
1707156|NCT00880048|3140533|Superiority||Mean Difference (Net)|-0.05||||0.8439|2-Sided|95.0|-0.55|0.45|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4|
1707157|NCT00880048|3140533|Superiority||Mean Difference (Net)|0.04||||0.8001|2-Sided|95.0|-0.3|0.39|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2|
1707158|NCT00880048|3140533|Superiority||Mean Difference (Net)|-0.25||||0.1442|2-Sided|95.0|-0.59|0.09|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2|
1707159|NCT00880048|3140533|Superiority||Mean Difference (Net)|-0.1||||0.6146|2-Sided|95.0|-0.47|0.28|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1|
1707160|NCT00880048|3140533|Superiority||Mean Difference (Net)|-0.57||||0.0024|2-Sided|95.0|-0.94|-0.21|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1|
1707161|NCT00880048|3140534|Superiority||Mean Difference (Net)|-17.1||||0.1054|2-Sided|95.0|-37.84|3.64|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, wake time after sleep onset|
1707162|NCT00880048|3140534|Superiority||Mean Difference (Net)|-14.51||||0.1561|2-Sided|95.0|-34.61|5.6|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, wake time after sleep onset|
1707163|NCT00880048|3140534|Superiority||Mean Difference (Net)|-9.44||||0.2134|2-Sided|95.0|-24.35|5.48|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, wake time after sleep onset|
1707164|NCT00880048|3140534|Superiority||Mean Difference (Net)|-2.5||||0.7387|2-Sided|95.0|-17.24|12.25|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, wake time after sleep onset|
1707165|NCT00880048|3140534|Superiority||Mean Difference (Net)|5.27||||0.5327|2-Sided|95.0|-11.35|21.89|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, wake time after sleep onset|
1707166|NCT00880048|3140534|Superiority||Mean Difference (Net)|1.89||||0.8195|2-Sided|95.0|-14.43|18.21|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, wake time after sleep onset|
1707167|NCT00880048|3140534|Superiority||Mean Difference (Net)|-16.15||||0.019|2-Sided|95.0|-29.61|-2.68|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, wake time after sleep onset|
1707168|NCT00880048|3140534|Superiority||Mean Difference (Net)|-17.19||||0.0108|2-Sided|95.0|-30.36|-4.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, wake time after sleep onset|
1707169|NCT00880048|3140534|Superiority||Mean Difference (Net)|-30.07||||0.0152|2-Sided|95.0|-54.29|-5.84|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, sleep onset latency|
1707170|NCT00880048|3140534|Superiority||Mean Difference (Net)|-28.58||||0.0177|2-Sided|95.0|-52.15|-5.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, sleep onset latency|
1707171|NCT00880048|3140534|Superiority||Mean Difference (Net)|-10.55||||0.2933|2-Sided|95.0|-30.26|9.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, sleep onset latency|
1707172|NCT00880048|3140534|Superiority||Mean Difference (Net)|-12.92||||0.1933|2-Sided|95.0|-32.43|6.59|||Mixed Models Repeated Measures|||Placebo va GW823296 30 mg: Week 4, sleep onset latency|
1707173|NCT00880048|3140534|Superiority||Mean Difference (Net)|1.75||||0.8707|2-Sided|95.0|-19.38|22.87|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, sleep onset latency|
1707174|NCT00880048|3140534|Superiority||Mean Difference (Net)|-12.45||||0.2373|2-Sided|95.0|-33.14|8.24|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, sleep onset latency|
1707175|NCT00880048|3140534|Superiority||Mean Difference (Net)|-25.49||||0.0052|2-Sided|95.0|-43.3|-7.68|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, sleep onset latency|
1707176|NCT00880048|3140534|Superiority||Mean Difference (Net)|-23.9||||0.0078|2-Sided|95.0|-41.46|-6.33|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, sleep onset latency|
1707177|NCT00880048|3140534|Superiority||Mean Difference (Net)|28.4||||0.0556|2-Sided|95.0|-0.69|57.5|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6, total sleep time|
1707178|NCT00880048|3140534|Superiority||Mean Difference (Net)|2.18||||0.8794|2-Sided|95.0|-26.1|30.46|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6, total sleep time|
1707179|NCT00880048|3140534|Superiority||Mean Difference (Net)|36.52||||0.0131|2-Sided|95.0|7.72|65.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4, total sleep time|
1707180|NCT00880048|3140534|Superiority||Mean Difference (Net)|30.87||||0.0344|2-Sided|95.0|2.29|59.45|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4, total sleep time|
1707181|NCT00880048|3140534|Superiority||Mean Difference (Net)|21.4||||0.125|2-Sided|95.0|-5.97|48.76|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2, total sleep time|
1707182|NCT00880048|3140534|Superiority||Mean Difference (Net)|7.62||||0.5773|2-Sided|95.0|-19.25|34.49|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2, total sleep time|
1707183|NCT00880048|3140534|Superiority||Mean Difference (Net)|33.21||||0.0179|2-Sided|95.0|5.76|60.65|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1, total sleep time|
1707184|NCT00880048|3140534|Superiority||Mixed effects repeated measures model|22.52||||0.103|2-Sided|95.0|-4.58|49.61|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1, total sleep time|
1707185|NCT00880048|3140535|Superiority||Mean Difference (Net)|-1.19||||0.2403|2-Sided|95.0|-3.18|0.8|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 6|
1707186|NCT00880048|3140535|Superiority||Mean Difference (Net)|-0.94||||0.3429|2-Sided|95.0|-2.89|1.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 6|
1707187|NCT00880048|3140535|Superiority||Mean Difference (Net)|-0.73||||0.4273|2-Sided|95.0|-2.53|1.07|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 4|
1707188|NCT00880048|3140535|Superiority||Mean Difference (Net)|-0.77||||0.3956|2-Sided|95.0|-2.54|1.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 4|
1707189|NCT00880048|3140535|Superiority||Mean Difference (Net)|-1.94||||0.0235|2-Sided|95.0|-3.62|-0.26|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 2|
1707190|NCT00880048|3140535|Superiority||Mean Difference (Net)|-1.4||||0.0963|2-Sided|95.0|-3.05|0.25|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2|
1707191|NCT00880048|3140535|Superiority||Mean Difference (Net)|-0.74||||0.3394|2-Sided|95.0|-2.27|0.78|||Mixed Models Repeated Measures|||Placebo vs GW823296 60 mg: Week 1|
1707192|NCT00880048|3140535|Superiority||Mean Difference (Net)|-1.57||||0.0421|2-Sided|95.0|-3.08|-0.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 1|
1707193|NCT00880048|3140536|Superiority||Mean Difference (Net)|-0.2||||0.2639|2-Sided|95.0|-0.55|0.15|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6|
1707194|NCT00880048|3140536|Superiority||Mean Difference (Net)|-0.38||||0.0313|2-Sided|95.0|-0.73|-0.03|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6|
1709140|NCT00852995|3144526|Superiority or Other|||||||0.011||||||Week 06|Cochran-Mantel-Haenszel||||
1707195|NCT00880048|3140536|Superiority||Mean Difference (Net)|-0.27||||0.088|2-Sided|95.0|-0.59|0.04|||Mixed Models Repeated Measures||Placebo vs GW823296 60mg: Week 4||
1707196|NCT00880048|3140536|Superiority||Mean Difference (Net)|-0.27||||0.0941|2-Sided|95.0|-0.58|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4|
1707197|NCT00880048|3140536|Superiority||Mean Difference (Net)|-0.2||||0.1458|2-Sided|95.0|-0.46|0.07|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2|
1707198|NCT00880048|3140536|Superiority||Mean Difference (Net)|-0.25||||0.0603|2-Sided|95.0|-0.51|0.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2|
1707199|NCT00880048|3140536|Superiority||Mean Difference (Net)|-0.27||||0.0107|2-Sided|95.0|-0.48|-0.06|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1|
1707200|NCT00880048|3140536|Superiority||Mean Difference (Net)|-0.15||||0.1472|2-Sided|95.0|-0.36|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1|
1707201|NCT00880048|3140537|Superiority||Odds Ratio (OR)|1.39||||0.3066|2-Sided|95.0|0.74|2.6|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 6|
1707202|NCT00880048|3140537|Superiority||Odds Ratio (OR)|1.44||||0.2408|2-Sided|95.0|0.78|2.65|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 6|
1707203|NCT00880048|3140537|Superiority||Odds Ratio (OR)|1.32||||0.3654|2-Sided|95.0|0.72|2.41|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 4|
1707204|NCT00880048|3140537|Superiority||Odds Ratio (OR)|1.13||||0.6895|2-Sided|95.0|0.62|2.07|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 4|
1707205|NCT00880048|3140537|Superiority||Odds Ratio (OR)|1.93||||0.1154|2-Sided|95.0|0.85|4.36|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 2|
1707206|NCT00880048|3140537|Superiority||Odds Ratio (OR)|2.91||||0.0067|2-Sided|95.0|1.34|6.3|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 2|
1707207|NCT00880048|3140537|Superiority||Odds Ratio (OR)|2.22||||0.1596|2-Sided|95.0|0.73|6.73|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 1|
1707208|NCT00880048|3140537|Superiority||Odds Ratio (OR)|2.83||||0.0562|2-Sided|95.0|0.97|8.22|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 1|
1707209|NCT00880048|3140538|Superiority||Mean Difference (Net)|-0.18||||0.5931|2-Sided|95.0|-0.86|0.49|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6|
1707210|NCT00880048|3140538|Superiority||Mean Difference (Net)|-0.32||||0.3399|2-Sided|95.0|-0.99|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6|
1707211|NCT00880048|3140538|Superiority||Mean Difference (Net)|-0.67||||0.0465|2-Sided|95.0|-1.33|-0.01|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4|
1707212|NCT00880048|3140538|Superiority||Mean Difference (Net)|-0.35||||0.287|2-Sided|95.0|-1.01|0.3|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4|
1707213|NCT00880048|3140538|Superiority||Mean Difference (Net)|-0.33||||0.2215|2-Sided|95.0|-0.86|0.2|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2|
1707214|NCT00880048|3140538|Superiority||Mean Difference (Net)|-0.15||||0.5605|2-Sided|95.0|-0.67|0.36|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2|
1707215|NCT00880048|3140538|Superiority||Mean Difference (Net)|-0.76||||0.002|2-Sided|95.0|-1.23|-0.28|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1|
1707216|NCT00880048|3140538|Superiority||Mean Difference (Net)|-0.28||||0.24|2-Sided|95.0|-0.75|0.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1|
1707217|NCT00880048|3140539|Superiority||Mean Difference (Net)|-1.41||||0.0794|2-Sided|95.0|-2.98|0.17|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6|
1707218|NCT00880048|3140539|Superiority||Mean Difference (Net)|-1.53||||0.0497|2-Sided|95.0|-3.06|0.0|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6|
1707219|NCT00880048|3140539|Superiority||Mean Difference (Net)|-1.86||||0.0103|2-Sided|95.0|-3.27|-0.44|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4|
1707220|NCT00880048|3140539|Superiority||Mean Difference (Net)|-1.58||||0.027|2-Sided|95.0|-2.97|-0.18|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4|
1707221|NCT00880048|3140539|Superiority||Mean Difference (Net)|-1.84||||0.0048|2-Sided|95.0|-3.12|-0.57|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2|
1707222|NCT00880048|3140539|Superiority||Mean Difference (Net)|-1.44||||0.0239|2-Sided|95.0|-2.68|-0.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2|
1707223|NCT00880048|3140539|Superiority||Mean Difference (Net)|-2.28|||<|0.0001|2-Sided|95.0|-3.36|-1.19|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1|
1707224|NCT00880048|3140539|Superiority||Mean Difference (Net)|-1.03|||<|0.0616|2-Sided|95.0|-2.11|0.05|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1|
1707225|NCT00880048|3140540|Superiority||Mean Difference (Net)|-0.52||||0.3627|2-Sided|95.0|-1.65|0.61|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6|
1707226|NCT00880048|3140540|Superiority||Mean Difference (Net)|-1.09||||0.055|2-Sided|95.0|-2.21|0.02|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6|
1707227|NCT00880048|3140540|Superiority||Mean Difference (Net)|-0.74||||0.15|2-Sided|95.0|-1.76|0.27|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4|
1707228|NCT00880048|3140540|Superiority||Mean Difference (Net)|-0.67||||0.1933|2-Sided|95.0|-1.67|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4|
1707229|NCT00880048|3140540|Superiority||Mean Difference (Net)|-0.62||||0.1407|2-Sided|95.0|-1.44|0.2|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2|
1707230|NCT00880048|3140540|Superiority||Mean Difference (Net)|-0.46||||0.2593|2-Sided|95.0|-1.27|0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 2|
1707231|NCT00880048|3140540|Superiority||Mean Difference (Net)|-0.81||||0.0155|2-Sided|95.0|-1.46|-0.16|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1|
1707232|NCT00880048|3140540|Superiority||Mean Difference (Net)|-0.69||||0.0362|2-Sided|95.0|-1.34|-0.04|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1|
1707233|NCT00880048|3140541|Superiority||Hazard Ratio (HR)|0.74||||0.35|2-Sided|95.0|0.36|1.54|||Log Rank||||
1707234|NCT00880048|3140541|Superiority||Hazard Ratio (HR)|0.98||||0.61|2-Sided|95.0|0.5|1.95|||Log Rank||||
1708391|NCT00858208|3143286|Superiority or Other|||||||0.7201|||||||paired t-test|||Change from baseline at Week 84|
1707235|NCT00880048|3140542|Superiority||Odds Ratio (OR)|1.15||||0.6916|2-Sided|95.0|0.58|2.25|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 6|
1707236|NCT00880048|3140542|Superiority||Odds Ratio (OR)|1.53||||0.1961|2-Sided|95.0|0.8|2.91|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 6|
1707237|NCT00880048|3140542|Superiority||Odds Ratio (OR)|1.47||||0.2554|2-Sided|95.0|0.76|2.86|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 4|
1707238|NCT00880048|3140542|Superiority||Odds Ratio (OR)|1.35||||0.379|2-Sided|95.0|0.69|2.64|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 4|
1707239|NCT00880048|3140542|Superiority||Odds Ratio (OR)|1.44||||0.4256|2-Sided|95.0|0.59|3.5|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 2|
1707240|NCT00880048|3140542|Superiority||Odds Ratio (OR)|1.52||||0.3395|2-Sided|95.0|0.64|3.61|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 2|
1707241|NCT00880048|3140542|Superiority||Odds Ratio (OR)|3.15||||0.0559|2-Sided|95.0|0.97|10.2|||Regression, Logistic|||Placebo vs GW823296 60mg: Week 1|
1707242|NCT00880048|3140542|Superiority||Odds Ratio (OR)|2.15||||0.2232|2-Sided|95.0|0.63|7.39|||Regression, Logistic|||Placebo vs GW823296 30mg: Week 1|
1707243|NCT00880048|3140543|Superiority or Other||Mean Difference (Net)|-0.76||||0.4713|2-Sided|95.0|-2.85|1.32|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 6|
1707244|NCT00880048|3140543|Superiority||Mean Difference (Net)|-1.67||||0.1122|2-Sided|95.0|-3.73|0.39|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 6|
1707245|NCT00880048|3140543|Superiority||Mean Difference (Net)|-2.03||||0.0369|2-Sided|95.0|-3.94|-0.12|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 4|
1707246|NCT00880048|3140543|Superiority||Mean Difference (Net)|-1.82||||0.0601|2-Sided|95.0|-3.71|0.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 4|
1707247|NCT00880048|3140543|Superiority||Mean Difference (Net)|-1.65||||0.0332|2-Sided|95.0|-3.16|-0.13|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 2|
1707248|NCT00880048|3140543|Superiority||Mean Difference (Net)|-1.57||||0.0394|2-Sided|95.0|-3.06|-0.08|||Mixed Models Repeated Measures|||Placebo vs GW823296 30 mg: Week 2|
1707249|NCT00880048|3140543|Superiority||Mean Difference (Net)|-2.26||||0.0006|2-Sided|95.0|-3.54|-0.98|||Mixed Models Repeated Measures|||Placebo vs GW823296 60mg: Week 1|
1707250|NCT00880048|3140543|Superiority||Mean Difference (Net)|-1.6||||0.0133|2-Sided|95.0|-2.87|-0.34|||Mixed Models Repeated Measures|||Placebo vs GW823296 30mg: Week 1|
1707251|NCT00879996|3140556|Superiority or Other||Odds Ratio (OR)|0.0|Standard Deviation|0.0|<|0.039|2-Sided|95.0|||||Fisher Exact|||Null hypothesis: methadone or buprenorphine treatment equally reduce illicit drug use.|
1707252|NCT00879996|3140557|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Deviation|0.0|<|0.665|2-Sided|95.0|||||ANOVA|||null-hypothesis: methadone and buprenorphine treatment are equally effective in reducing self-reported functioning at 6 months.|
1707253|NCT00879996|3140558|Superiority or Other||Mean Difference (Final Values)|0.2|||<|0.043||95.0|||||ANOVA|||Null hypothesis: Methadone treatment is as effective as buprenorphine treatment in reducing pain.|
1707254|NCT00879996|3140559|Superiority or Other||Hazard Ratio (HR)|0.9134||||0.77|2-Sided|95.0|0.4156|2.007|||Log Rank|||Null hypothesis: Methadone and buprenorphine treatment do not differ in treatment retention.|
1707255|NCT00879697|3140612|Superiority or Other||||||<|0.05|||||||ANOVA|||The effect of training in both groups were assessed by a 2-way ANOVA (Time x Group) for repeated measures. When significance was obtained, the Newman-Keuls post hoc test was used to identify the differences.|
1707256|NCT00879658|3140626|Superiority|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.231||||0.006|2-Sided|95.0|0.081|0.653||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic||||
1707257|NCT00879658|3140626|Superiority|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.24||||0.018|2-Sided|95.0|0.074|0.779||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic||||
1707258|NCT00879658|3140626|Superiority|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.214|||<|0.001|2-Sided|95.0|0.091|0.499||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic||||
1707259|NCT00879658|3140627|Superiority|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.504||||0.169|2-Sided|95.0|0.19|1.337||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic||||
1707260|NCT00879658|3140627|Superiority||lesion ratio|0.271||||0.019|2-Sided|95.0|0.091|0.807||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic|||Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|
1707261|NCT00879658|3140627|Superiority|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.052||||0.005|2-Sided|95.0|0.007|0.405||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic||||
1709141|NCT00852995|3144526|Superiority or Other|||||||0.017||||||Week 05|Cochran-Mantel-Haenszel||||
1707262|NCT00879658|3140627|Superiority|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.159||||0.005|2-Sided|95.0|0.044|0.578||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic||||
1707263|NCT00879658|3140627|Superiority|Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.|lesion ratio|0.129||||0.006|2-Sided|95.0|0.03|0.561||p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.|Regression, Logistic||||
1707264|NCT00879658|3140628|Superiority|||||||0.124||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic||||
1707265|NCT00879658|3140628|Superiority|||||||0.022||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic||||
1707266|NCT00879658|3140628|Superiority|||||||0.335||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic||||
1707267|NCT00879658|3140629|Superiority|||||||0.034||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic||||
1707268|NCT00879658|3140629|Superiority|||||||0.122||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic||||
1707269|NCT00879658|3140629|Superiority|||||||0.001||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic||||
1707270|NCT00879658|3140629|Superiority|||||||0.02||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic||||
1707271|NCT00879658|3140629|Superiority|||||||0.227||||||Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.|Regression, Logistic||||
1707272|NCT00879658|3140630|Superiority||lesion ratio|0.416||||0.139|2-Sided|95.0|0.13|1.331||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707273|NCT00879658|3140630|Superiority||lesion ratio|0.197||||0.001|2-Sided|95.0|0.074|0.527||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707274|NCT00879658|3140630|Superiority|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.161|||<|0.001|2-Sided|95.0|0.062|0.421||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic||||
1707275|NCT00879658|3140631|Superiority||lesion ratio|0.591||||0.142|2-Sided|95.0|0.292|1.193||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707276|NCT00879658|3140631|Superiority||lesion ratio|0.683||||0.485|2-Sided|95.0|0.234|1.991||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707277|NCT00879658|3140631|Superiority||lesion ratio|0.118|||<|0.001|2-Sided|95.0|0.034|0.409||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707278|NCT00879658|3140631|Superiority||lesion ratio|0.276|||<|0.005|2-Sided|95.0|0.112|0.676||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707279|NCT00879658|3140631|Superiority|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.259|||<|0.005|2-Sided|95.0|0.1|0.67||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic||||
1707320|NCT00879398|3140652|Superiority or Other||||||<|0.3078||||||Statistical significant level: 0.05|Chi-squared|||Comparison among Weight Categories: <50 kg, 50 to 60 kg, 60 to 70 kg, and ≥70 kg.|
1707321|NCT00879398|3140652|Superiority or Other||||||<|0.0289||||||Statistical significant level: 0.05|Chi-squared|||Male vs Female|
1707280|NCT00879658|3140632|Superiority||lesion ratio|0.173|||<|0.001|2-Sided|95.0|0.069|0.434||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707281|NCT00879658|3140632|Superiority||lesion ratio|0.18|||<|0.001|2-Sided|95.0|0.069|0.47||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707282|NCT00879658|3140632|Superiority|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.095|||<|0.001|2-Sided|95.0|0.033|0.273||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic||||
1707283|NCT00879658|3140633|Superiority||lesion ratio|0.555||||0.087|2-Sided|96.0|0.283|1.09||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707284|NCT00879658|3140633|Superiority||lesion ratio|0.454||||0.035|2-Sided|95.0|0.219|0.945||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707285|NCT00879658|3140633|Superiority||lesion ratio|0.154|||<|0.001|2-Sided|95.0|0.059|0.4||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707286|NCT00879658|3140633|Superiority||lesion ratio|0.396|||<|0.019|2-Sided|95.0|0.182|0.861||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707287|NCT00879658|3140633|Superiority|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|lesion ratio|0.279|||<|0.002|2-Sided|95.0|0.124|0.628||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic||||
1707288|NCT00879658|3140634|Superiority||lesion ratio|0.188|||<|0.001|2-Sided|95.0|0.07|0.509||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707289|NCT00879658|3140634|Superiority||lesion ratio|0.228|||<|0.005|2-Sided|95.0|0.081|0.641||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707290|NCT00879658|3140634|Superiority|Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|Lesion ratio|0.154|||<|0.001|2-Sided|95.0|0.063|0.376|||Regression, Logistic|new lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|||
1707291|NCT00879658|3140635|Superiority||lesion ratio|0.478||||0.062|2-Sided|95.0|0.22|1.037||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707292|NCT00879658|3140635|Superiority||lesion ratio|0.375||||0.021|2-Sided|95.0|0.163|0.86||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707293|NCT00879658|3140635|Superiority||lesion ratio|0.113|||<|0.001|2-Sided|95.0|0.036|0.358||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707294|NCT00879658|3140635|Superiority||lesion ratio|0.307|||<|0.012|2-Sided|95.0|0.123|0.771||new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.|Regression, Logistic|||Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707295|NCT00879658|3140635|Superiority||lesion ratio|0.138|||<|0.001|2-Sided|95.0|0.047|0.408|||Regression, Logistic|new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model||Pairwise treatment comparison between different BAF312 dose groups and placebo used a two-sided significance level of 5% without adjusting for multiplicity.|
1707296|NCT00879658|3140636|Other|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.266||||0.642|2-Sided|95.0|0.468|3.494||Proportions are estimated from the logistic regression model. - An odds ratio of > 1 indicates an increased odds in favor of the active treatment.|Regression, Logistic||||
1707322|NCT00879398|3140652|Superiority or Other||||||<|0.601||||||Statistical significant level: 0.05|Chi-squared|||Comparison among Age Categories: <50 years, 50 to 59 years, 60 to 69 years, 70 to 79 years, and ≥80 years.|
1709142|NCT00852995|3144526|Superiority or Other|||||||0.041||||||Week 04|Cochran-Mantel-Haenszel||||
1707297|NCT00879658|3140636|Other|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|4.12||||0.014|2-Sided|95.0|1.328|14.681||Proportions are estimated from the logistic regression model. - An odds ratio of > 1 indicates an increased odds in favor of the active treatment.|Regression, Logistic||||
1707298|NCT00879658|3140636|Other|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.996||||0.178|2-Sided|95.0|0.731|5.669|||Regression, Logistic|Proportions are estimated from the logistic regression model. - An odds ratio of > 1 indicates an increased odds in favor of the active treatment.|||
1707299|NCT00879658|3140637|Other|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.785||||0.668|2-Sided|95.0|0.253|2.392||"Proportions are estimated from the logistic regression model.~- An odds ratio of > 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic||||
1707300|NCT00879658|3140637|Other|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.509||||0.223|2-Sided|95.0|0.166|1.511||"Proportions are estimated from the logistic regression model.~- An odds ratio of > 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic||||
1707301|NCT00879658|3140637|Other|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.697||||0.454|2-Sided|95.0|0.438|8.296||"Proportions are estimated from the logistic regression model.~- An odds ratio of > 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic||||
1707302|NCT00879658|3140637|Other|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|1.745||||0.399|2-Sided|95.0|0.484|7.167||"Proportions are estimated from the logistic regression model.~- An odds ratio of > 1 indicates an increased odds in favor of the active treatment."|Regression, Logistic||||
1707303|NCT00879658|3140637|Other|Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.|Logistic regression model|0.915||||0.879|2-Sided|95.0|0.288|2.925|||Regression, Logistic|"Proportions are estimated from the logistic regression model.~- An odds ratio of > 1 indicates an increased odds in favor of the active treatment."|||
1707304|NCT00879658|3140638|Superiority||Negative binomial regression model|1.051||||0.899|2-Sided|95.0|0.486|2.273||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio <1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.|||
1707305|NCT00879658|3140638|Superiority||Negative binomial regression model|0.34||||0.041|2-Sided|95.0|0.121|0.956||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio <1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.|||
1707306|NCT00879658|3140638|Superiority||Negative binomial regression model|0.524||||0.148|2-Sided|95.0|0.219|1.257||Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio <1 favors active treatment.|Mixed Models Analysis|Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.|||An ARR-ratio <1 favors active treatment.
1707307|NCT00879398|3140652|Superiority or Other|||||||0.001||||||Statistical significant level: 0.05|Chi-squared|||Concurrent Medication: Yes vs Concurrent Medication: No|
1707308|NCT00879398|3140652|Superiority or Other|||||||0.5889||||||Statistical significant level: 0.05|Fisher Exact|||Total Administration Period <274 days vs Total Administration Period ≥ 274 days|
1707309|NCT00879398|3140652|Superiority or Other||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Completion vs Discontinuation|
1707310|NCT00879398|3140652|Superiority or Other||||||<|0.0239||||||Statistical significant level: 0.05|Fisher Exact|||Comparison among Daily Dose of Toviaz: 3 mg, 4 mg, >4 mg to <8 mg, and 8 mg.|
1707311|NCT00879398|3140652|Superiority or Other||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Comparison among Total Administration Period of Toviaz Subgroups: <2 months, 2 to 4 months, and ≥4 months.|
1707312|NCT00879398|3140652|Superiority or Other||||||<|1||||||Statistical significant level: 0.05|Fisher Exact|||Liver Disorder: Yes vs Liver Disorder: No|
1707313|NCT00879398|3140652|Superiority or Other||||||<|1||||||Statistical significant level: 0.05|Fisher Exact|||Kidney Disorder: Yes vs Kidney Disorder: No|
1707314|NCT00879398|3140652|Superiority or Other||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Medical History of Present Disease: Yes vs Medical History of Present Disease: No|
1707315|NCT00879398|3140652|Superiority or Other||||||<|0.1147||||||Statistical significant level: 0.05|Chi-squared|||Medical History of Past Disease: Yes vs Medical History of Past Disease: No|
1707316|NCT00879398|3140652|Superiority or Other||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Past OAB Treatment History: Yes vs Past OAB Treatment History: No|
1707317|NCT00879398|3140652|Superiority or Other||||||<|0.0001||||||Statistical significant level: 0.05|Chi-squared|||Comparison among Duration of Disease: <1 week, 1 to 8 weeks, 8 to 16 weeks, and ≥16 weeks.|
1707318|NCT00879398|3140652|Superiority or Other||||||<|0.0788||||||Statistical significant level: 0.05|Fisher Exact|||Allergic History: Yes vs Allergic History: No|
1707319|NCT00879398|3140652|Superiority or Other||||||<|0.9614||||||Statistical significant level: 0.05|Chi-squared|||Comparison among Height Categories: <160 cm, 160 to 170 cm, and ≥170 cm.|
1708392|NCT00858208|3143286|Superiority or Other|||||||0.7544|||||||paired t-test|||Change from baseline at Week 72|
1707323|NCT00879398|3140652|Superiority or Other||||||<|0.1319||||||Statistical significant level: 0.05|Chi-squared|||Geriatric Status: <65 years versus (vs) Geriatric Status: ≥65 years|
1707324|NCT00879398|3140654|Superiority or Other||||||<|0.0001||||||Statistical significant level: 0.05|t-test, 2 sided||||
1707325|NCT00879398|3140655|Superiority or Other||||||<|0.0001||||||Statistical significant level: 0.05|t-test, 2 sided||||
1707326|NCT00879398|3140656|Superiority or Other||||||<|0.0001||||||Statistical significant level: 0.05|t-test, 2 sided||||
1707327|NCT00879359|3140661|Superiority or Other||Hazard Ratio, log|92.0|||||2-Sided|95.0|64.0|99.0|||||||
1707328|NCT00879255|3140669|Non-Inferiority or Equivalence|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-5.56|||>|0.05|2-Sided|95.0|-16.26|5.14||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority test|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).||
1707329|NCT00879255|3140670|Non-Inferiority or Equivalence|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-4.76|||>|0.05|2-Sided|95.0|-11.65|2.13||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority design|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).||
1707330|NCT00879255|3140671|Non-Inferiority or Equivalence|We used a noninferiority design to test the hypothesis that VTC is noninferior to in-person treatment delivery. The noninferiority margin was determined to be 10 CAPS points. We analyzed means differences in CAPS scores between the two treatment conditions (VTC minus in-person) with positive values indicating greater reductions in VTC condition. Power was estimated to be 90% with alpha = .20, and a between-group difference equaling an effect size of d = .50 (estimated 10 CAPS points).|Mean Difference (Final Values)|-4.75|||>|0.05|2-Sided|95.0|-11.92|2.42||"The noninferiority margin is the maximum clinically meaningful amount by which VTC can be worse than the in-person delivery to allow for a conclusion of noninferiority (a priori set to 10 CAPS points)."|noninferiority analysis|We hypothesized that VTC is noninferior to in-person condition, which is supported if upper limit of 95% CI is less than preset noninferiority margin.|The noninferiority hypothesis would be supported if the 95% Confidence Interval of the difference in CAPS scores between the 2 conditions (VTC minus in-person scores) is less than the present noninferiority margin (10 CAPS points).||
1707331|NCT00879229|3140681|Superiority or Other||Mean Difference (Final Values)|-29.0|Standard Error of the Mean|67.0||0.696|2-Sided|95.0|-54.0|17.0||This is an exact Wilcoxon rank sum test p-value for testing equality of ambrisentan and placebo distributions.|Wilcoxon (Mann-Whitney)||||
1707332|NCT00879190|3140682|Superiority or Other|||||||0.6|||||||Fisher Exact||||
1707333|NCT00879190|3140683|Superiority or Other|||||||0.03|||||||Fisher Exact||||
1707334|NCT00879190|3140684|Superiority or Other|||||||1|||||||Fisher Exact||||
1707335|NCT00878826|3140745|Superiority or Other|||||||0.3|||||||Kruskal-Wallis|||at 32-34 weeks gestational age|
1707336|NCT00878826|3140745|Superiority or Other|||||||0.9|||||||Kruskal-Wallis|||at 24-28 weeks gestational age|
1707337|NCT00878826|3140745|Superiority or Other|||||||0.4|||||||Kruskal-Wallis|||at 14-18 weeks gestational age|
1707338|NCT00878709|3140771|Superiority||Hazard Ratio (HR)|0.73|||||2-Sided|95.0|0.51|1.04|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (<= 3 or >= 4) and ER/PgR status (positive or negative).|Time to distant recurrence (TTDR) in neratinib arm compared to placebo arm.|
1707339|NCT00878709|3140773|Superiority||Hazard Ratio (HR)|0.74|||||2-Sided|95.0|0.52|1.05|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (<= 3 or >= 4) and ER/PgR status (positive or negative).|Distant disease free survival (DDFS) in neratinib arm compared to placebo arm.|
1707340|NCT00878709|3140775|Superiority||Hazard Ratio (HR)|0.61|||||2-Sided|95.0|0.45|0.83|||||The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (<= 3 or >= 4) and ER/PgR status (positive or negative).|Disease-free survival including ductal carcinoma in situ (DFS-DCIS) in neratinib arm compared to placebo arm.|
1707341|NCT00878709|3140778|Superiority||Hazard Ratio (HR)|0.66||||0.008|2-Sided|95.0|0.49|0.9|||Log Rank|The Log-rank test is stratified by prior trastuzumab (concurrent or sequential), nodal status (<= 3 or >= 4) and ER/PgR status (positive or negative).|The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by prior trastuzumab (concurrent or sequential), nodal status (<= 3 or >= 4) and ER/PgR status (positive or negative).|Invasive disease-free survival (iDFS) in neratinib arm compared to placebo arm.|
1707342|NCT00878644|3140779|Superiority|||||||0.81|||||||Wilcoxon (Mann-Whitney)|"Test used the continuous (NOT categorized as reported above) neuropsychological scores, with Lowest Possible Score treated as lowest possible value."|||
1707601|NCT00873730|3141406|Superiority or Other|||||||0.5364|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Overall Spinal Pain.|
1707343|NCT00878644|3140780|Superiority|||||||0.13|||||||Stratified Mann-Whitney Test|Test stratified by age category (<2 years, 2 to <12 years, or >=12 years), for continuous (NOT categorized as reported above) 1-year change in VABS-II|||As the (nonparametric) comparison treated 1-year deaths as worst possible outcomes and worst possible 1-year VABS-II as next worst possible outcomes, using change in VABS-II for other participants alive at 1 year, no relevant estimation of effect size is possible for this secondary outcome.
1707344|NCT00878644|3140781|Superiority||Risk Difference (RD)|9.1||||0.13|2-Sided|95.0|-1.8|19.9|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (<2 years, 2 to <12 years, or >=12 years)|||
1707345|NCT00878644|3140782|Superiority||Risk Difference (RD)|7.3||||0.14|2-Sided|95.0|-1.5|16.1|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test was used adjusting for age category at time of randomization (<2 years, 2 to <12 years, or >=12 years)|||
1707346|NCT00878553|3140784|Superiority or Other||Mean Difference (Net)|0.74||||0.4835||95.0|||||ANOVA|2 degrees of freedom F-test||Half-Life (t1/2 in hours) of plasma zaleplon from each of 3 doses of SKP-1041|
1707347|NCT00878553|3140785|Superiority or Other||Mean Difference (Net)|1.28||||0.2281||95.0|||||ANOVA|F-test 2 degrees of freedom||AUC/Dose (ng*h/mL/mg)|
1707348|NCT00878553|3140786|Superiority or Other||Mean Difference (Net)|9.85||||0.0003||95.0|||||ANOVA|F-test 2 degrees of freedom||AUC ng*h/mL)|
1707349|NCT00878553|3140787|Superiority or Other||Mean Difference (Net)|2.24||||0.1193||95.0|||||ANOVA|F-test 2 degrees of freedom||Time (hour)post-dose of maximum plasma zaleplon concentration|
1707350|NCT00878553|3140788|Superiority or Other||Mean Difference (Net)|0.09||||0.9142||95.0|||||ANOVA|F-test two degrees of freedom||Cmax normalized per dose|
1707351|NCT00878553|3140789|Superiority or Other||Mean Difference (Net)|8.39||||0.0009|2-Sided||||||ANOVA|F-test 2 degrees of freedom||Cmax(ng/mL) [Maximum plasma zaleplon concentration]|
1707352|NCT00878553|3140790|Superiority or Other||Mean Difference (Net)|2.314|Standard Error of the Mean|2.058||0.2433|2-Sided|95.0|-1.586|6.214||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates an improvement.||
1707353|NCT00878553|3140790|Superiority or Other||Mean Difference (Net)|0.821|Standard Error of the Mean|2.422||0.6784|2-Sided|95.0|-3.08|4.722||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates an improvement.||
1707354|NCT00878553|3140790|Superiority or Other||Mean Difference (Net)|0.71|Standard Error of the Mean|1.818||0.719|2-Sided|95.0|-3.175|4.595||Adjusted mean differences were analyzed in a general linear model that used change from baseline as the response variable.|Mixed Models Analysis|The Model included effects for patient, period, sequence and treatment.|A positive mean change from baseline indicates improvement.||
1707355|NCT00878553|3140791|Superiority or Other||Mean Difference (Net)|-0.262|Standard Error of the Mean|0.237||0.3254|2-Sided|95.0|-0.787|0.263|||Mixed Models Analysis||A negative mean change from baseline indicates a worsening.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.|
1707356|NCT00878553|3140791|Superiority or Other||Mean Difference (Net)|0.165|Standard Error of the Mean|0.259||0.536|2-Sided|95.0|-0.36|0.69|||Mixed Models Analysis||A positive mean change from baseline indicates an improvement.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.|
1707357|NCT00878553|3140791|Superiority or Other||Mean Difference (Net)|0.45|Standard Error of the Mean|0.256||0.0914|2-Sided|95.0|-0.073|0.972|||Mixed Models Analysis||A positive mean change from baseline indicates an improvement.|The adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence and treatment.|
1707358|NCT00878553|3140792|Superiority or Other||Mean Difference (Net)|1.434|Standard Error of the Mean|1.626||0.2385|2-Sided|95.0|-0.958|3.826||Analysis included effects for patient, period, sequence and treatment.|Mixed Models Analysis||A positive mean difference from baseline indicates improvement.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.|
1707359|NCT00878553|3140792|Superiority or Other||Mean Difference (Net)|-1.912|Standard Error of the Mean|1.523||0.1167|2-Sided|95.0|-4.304|0.481||Analysis included effects for patient, period, sequence and treatment|Mixed Models Analysis||A negative mean difference from baseline indicates a worsening.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.|
1707360|NCT00878553|3140792|Superiority or Other||Mean Difference (Net)|0.56|Standard Error of the Mean|1.469||0.6433|2-Sided|95.0|-1.823|2.943||Analysis included effects for patient, period, sequence and treatment.|Mixed Models Analysis||A positive mean difference from baseline indicates improvement.|Adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable.|
1707361|NCT00878553|3140793|Superiority or Other||Mean Difference (Net)|-11.84|Standard Error of the Mean|4.936||0.0894|2-Sided|95.0|-25.522|1.842||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.|
1707383|NCT00877890|3140908|Superiority or Other||Least Squares Mean Difference|-16.0|Standard Error of the Mean|3.5|<|0.0001|2-Sided|95.0|-22.9|-9.1|||ANCOVA|||Analysis: Change in total cholesterol from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.|
1707362|NCT00878553|3140793|Superiority or Other||Mean Difference (Net)|1.365|Standard Error of the Mean|4.937||0.8441|2-Sided|95.0|-12.327|15.056||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A positive mean change from baseline indicates a worsening.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.|
1707363|NCT00878553|3140793|Superiority or Other||Mean Difference (Net)|-8.452|Standard Error of the Mean|0.219||0.219|2-Sided|95.0|-21.98|5.077||Mean (SEM) = adjusted mean change from baseline in each group (and standard error of the mean) and P value = P value for the comparison of the SEM of the active group with that of the placebo group.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Study was powered on the primary endpoint. Data for sWASO were sourced from Question 5 of the Morning Sleep Questionnaire. Its analysis follows a general linear model change from baseline as response variable including effects for patient, period, sequence, and treatment.|
1707364|NCT00878553|3140794|Superiority or Other||Mean Difference (Net)|-0.793|Standard Error of the Mean|0.244||0.0216|2-Sided|95.0|-1.467|-0.118||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustments for multiple testing were made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.|
1707365|NCT00878553|3140794|Superiority or Other||Mean Difference (Net)|-1.037|Standard Error of the Mean|0.244||0.0028|2-Sided|95.0|-1.712|-0.362||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.|
1707366|NCT00878553|3140794|Superiority or Other||Mean Difference (Net)|-0.562|Standard Error of the Mean|0.244||0.1005|2-Sided|95.0|-1.235|0.11||Adjusted mean differences were analyzed with a general linear model that used change from baseline as the response variable and included effects for patient, period,sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|This endpoint summarizes the number of times during Hours 3 7, after onset of persistent sleep, that there was a wake entry of at least 2 epochs duration. To be counted, each entry must have been separated by a sleep stage of 2, 3 4, or rapid eye movement.|
1707367|NCT00878553|3140795|Superiority or Other||Mean Difference (Net)|10.147|Standard Error of the Mean|2.402||0.003|2-Sided|95.0|3.498|16.796||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.|
1707368|NCT00878553|3140795|Superiority or Other||Mean Difference (Net)|10.425|Standard Error of the Mean|2.402||0.0023|2-Sided|95.0|3.775|17.075||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.|
1707369|NCT00878553|3140795|Superiority or Other||Mean Difference (Net)|8.831|Standard Error of the Mean|2.4||0.0092|2-Sided|95.0|2.208|15.454||All aspects of the study's primary endpoint were statistically significant, and no adjustment for multiple testing was made for secondary efficacy endpoints.|Mixed Models Analysis||A positive mean difference from baseline indicates an improvement.|The adjusted mean differences were analyzed by using a general linear model that used change from baseline as the response variable and included effects for patient, period, sequence, and treatment.|
1707370|NCT00878553|3140796|Superiority or Other||Mean Difference (Net)|-5.521|Standard Error of the Mean|2.757||0.1553|2-Sided|95.0|-13.154|2.113||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.|
1707371|NCT00878553|3140796|Superiority or Other||Mean Difference (Net)|-6.912|Standard Error of the Mean|2.757||0.0757|2-Sided|95.0|-14.546|0.722||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.|
1709143|NCT00852995|3144526|Superiority or Other|||||||0.017||||||Week 04|Cochran-Mantel-Haenszel||||
1707372|NCT00878553|3140796|Superiority or Other||Mean Difference (Net)|-5.604|Standard Error of the Mean|2.755||0.1476|2-Sided|95.0|-13.208|2.0||Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment.|Mixed Models Analysis|No adjustment for multiple testing was made for secondary efficacy endpoints.|A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.|
1707373|NCT00878553|3140797|Superiority or Other||Mean Difference (Net)|-9.153|Standard Error of the Mean|2.422||0.0077|2-Sided|95.0|-15.857|-2.448||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo.|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05.|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement|Literature-based estimates of WASO SD range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 20-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes.|
1707374|NCT00878553|3140797|Superiority or Other||Mean Difference (Net)|-9.98|Standard Error of the Mean|2.421||0.0037|2-Sided|95.0|-16.685|-3.275||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement|Literature-based estimates of WASO SD range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes|
1707375|NCT00878553|3140797|Superiority or Other||Mean Difference (Net)|-8.606|Standard Error of the Mean|2.42||0.0118|2-Sided|95.0|-15.284|-1.927||Change from baseline in mean WASO3-7 compared values for the 20-mg dose vs. placebo. If that comparison demonstrated superiority of the 20-mg dose, then results for the 15-mg dose vs. placebo were compared; if significant, then 10-mg vs. placebo|Mixed Models Analysis|This hierarchical, 2-sided testing procedure maintained the overall level of significance at approximately 0.05|Adjusted mean differences were analyzed via general linear model that used change from baseline as response variable and included effects for patient, period, sequence, and treatment. A negative mean change from baseline indicates an improvement.|Literature-based estimates of WASO (Wake After Sleep Onset) SD (Standard Deviation) range from 39 to 45 minutes. Null hypothesis: difference between mean WASO3-7 values for placebo and the 15-mg SKP-1041 dose level equals 0. By using a 2-sided, 1-sample t test at the 5% level of significance of this null hypothesis and an assumed SD of 45 minutes, a sample size of 54 completed patients was calculated to provide 90% power to detect a mean treatment difference of 20 minutes|
1707376|NCT00877929|3140899|Superiority or Other||Mean Difference (Final Values)|-4.9||||0.0001||95.0|-6.6|-3.2|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.|||
1707377|NCT00877929|3140900|Superiority or Other||Mean Difference (Final Values)|-6.1||||0.0001||95.0|-7.9|-4.3|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.|||
1707378|NCT00877929|3140901|Superiority or Other||Mean Difference (Final Values)|-6.6||||0.0001||95.0|-8.3|-4.9|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.|||
1707379|NCT00877929|3140902|Superiority or Other||Mean Difference (Final Values)|-7.1||||0.0001||95.0|-8.9|-5.4|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.|||
1707380|NCT00877929|3140903|Superiority or Other||Mean Difference (Final Values)|-6.1||||0.0001||95.0|-7.9|-4.2|||ANCOVA|Included effects of treatment, week and treatment-by-week interaction with covariate of baseline blood pressure and baseline-week interaction.|||
1707381|NCT00877890|3140906|Superiority or Other||Geometric Least Squares Mean Ratio|0.95|Standard Error of the Mean|0.043||0.2558|2-Sided|95.0|0.87|1.04|||ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day 1) , expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.|
1707382|NCT00877890|3140907|Superiority or Other||Least Squares Mean Difference|-1.2|Standard Error of the Mean|0.8||0.1251|2-Sided|95.0|-2.8|0.3|||ANCOVA|||Analysis: Change in HDL from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.|
1707405|NCT00877006|3140987|Superiority or Other|||||||0.0005||||||P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment group, region, preassigned standard treatment, and lymphoma type as factors and baseline value as the covariate.|ANCOVA|||The hypothesis of interest is superiority of BR over standard treatment.|
1707384|NCT00877890|3140909|Superiority or Other||Least Squares Mean Difference|0.3|Standard Error of the Mean|0.98||0.7717|2-Sided|95.0|-1.7|2.2|||ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the diastolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline diastolic blood pressure. Power: based on the primary measurement.|
1707385|NCT00877890|3140910|Superiority or Other||Least Squares Mean Difference|-1.8|Standard Error of the Mean|1.5||0.2367|2-Sided|95.0|-4.7|1.2|||ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the systolic blood pressure as a covariate. Null hypothesis: no difference between treatments in change from baseline systolic blood pressure. Power: based on the primary measurement.|
1707386|NCT00877890|3140911|Superiority or Other||Least Squares Mean Difference|-0.95|Standard Error of the Mean|0.487||0.0514|2-Sided|95.0|-1.91|0.01|||ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.|
1707387|NCT00877890|3140912|Superiority or Other|||||||0.0008||||||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of <7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of <=126 mg/dL) was performed.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving fasting plasma glucose target of <=126 mg/dL at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (<9% or >=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving fasting plasma glucose target. Power: based on the primary measurement.|
1707388|NCT00877890|3140913|Superiority or Other||Least Squares Mean Difference|-20.4|Standard Error of the Mean|5.57||0.0006|2-Sided|95.0|-31.4|-9.5||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of <7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of <=126 mg/dL) was performed.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 24 was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.|
1707389|NCT00877890|3140914|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target values of <=6.5% at Week 24 were compared between treatments using a CMH test, in which baseline HbA1c stratum (<9% or >=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.|
1707390|NCT00877890|3140915|Superiority or Other||||||<|0.0001||||||Multiplicity adjustment using Hochberg procedure for the 3 key secondary endpoints (i.e., percent to achieving HbA1c goal of <7%, change in fasting glucose, and percent of achieving fasting plasma glucose goal of <=126 mg/dL) was performed.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target value of <7% at Week 24 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (<9% or >=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.|
1707391|NCT00877890|3140916|Non-Inferiority or Equivalence|The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide once weekly and BYETTA, regulatory guidance, published literature, and statistical considerations.|Least Squares Mean Difference|-0.67|Standard Error of the Mean|0.138|<|0.0001|2-Sided|95.0|-0.94|-0.39|||ANOVA|Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors.||Superiority of exenatide once weekly to BYETTA if the upper limit of the 2-sided 95% CI for treatment difference (exenatide once weekly minus BYETTA) is <0; noninferiority if this upper limit is <0.4%. Power: Assuming 15% dropout rate with 206 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in exenatide once weekly and a common standard deviation of 1.1%.|
1707392|NCT00877799|3140935|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1707393|NCT00877799|3140936|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1707394|NCT00877799|3140937|Superiority or Other|||||||0.057|||||||t-test, 2 sided||||
1707395|NCT00877487|3140948|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1707396|NCT00877487|3140949|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1707397|NCT00877487|3140950|Superiority or Other||Mean Difference (Final Values)|-15.23|||<|0.0001|2-Sided|95.0|-19.1|-11.4|||ANCOVA||||
1707398|NCT00877058|3140964|Superiority or Other||Odds Ratio (OR)|0.58|||<|0.05|2-Sided|95.0|0.33|1.02|||Chi-squared||||
1707399|NCT00877058|3140964|Superiority or Other||Odds Ratio (OR)|0.55|||<|0.05|2-Sided|95.0|0.31|0.97|||Chi-squared||||
1707400|NCT00877058|3140965|Superiority or Other||Odds Ratio (OR)|1.28|||<|0.05|2-Sided|95.0|0.79|2.08|||Chi-squared||||
1707401|NCT00877058|3140965|Superiority or Other||Odds Ratio (OR)|1.56|||<|0.05|2-Sided|95.0|0.96|2.52|||Chi-squared||||
1707402|NCT00877058|3140966|Superiority or Other||Odds Ratio (OR)|0.4||||0.001|2-Sided|0.05|0.24|0.68|||Chi-squared||||
1707403|NCT00877058|3140966|Superiority or Other||Odds Ratio (OR)|0.27|||<|0.05|2-Sided|95.0|0.15|0.48|||Chi-squared||||
1707404|NCT00877006|3140986|Superiority||Hazard Ratio (HR)|0.99||||0.9677|2-Sided|95.0|0.58|1.68|||Log Rank|Stratified log-rank test by preassigned standard treatment and lymphoma type.|BR/RCHOP-RCVP||
1707507|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|32.0||||0.639|2-Sided|95.0|-105.6|169.6|||ANCOVA|||Statistical analysis of left lower lung region (RV) at Week 104.|
1707406|NCT00876928|3141002|Superiority or Other|||||||0.39|||||||ANOVA|||The null hypothesis is that there would be no difference in the changes in the Disposition Index between the 2 groups over the year.|
1707407|NCT00876928|3141003|Superiority or Other||Percent of patients developing diabetes|10.0||||0.61|2-Sided|95.0|8.0|12.0||A chi square test was used for the number of participants developing diabetes and a 2-way repeated measures ANOVA for the disposition index|Chi-squared||Primary outcome compared the number of participants developing diabetes after receiving vitamin D or placebo for one year. Secondary outcome compared changes in 2-way repeated measures ANOVA; therefore,no confidence intervals/dispersion parameters|Null hypothesis is that there is no effect of vitamin D on the development of diabetes in people with pre-diabetes and hypovitaminosis D. There were no published data when this trial was started on the effect of vitamin D in pre-diabetes making a power calculation difficult.|
1707408|NCT00876915|3141010|Superiority or Other||Hazard Ratio (HR)|7.019||||0.0252|2-Sided|95.0|1.236|131.632|||stratified Cox||||
1707409|NCT00876915|3141011|Superiority or Other||Hazard Ratio (HR)|0.695||||0.4795|2-Sided|95.0|0.235|1.89|||stratified Cox||||
1707410|NCT00876395|3141081|Superiority|||||||0.6382|||||||Exact Cochran-Mantel-Haenzel chi-square||||
1707411|NCT00876395|3141082|Superiority|||||||0.9573|||||||Exact Cochran-Mantel-Haenzel chi-square||||
1707412|NCT00876395|3141083|Superiority|||||||0.4085|||||||Exact Cochran-Mantel-Haenzel chi-square||||
1707413|NCT00876395|3141084|Superiority|||||||0.7276|||||||Exact Cochran-Mantel-Haenzel chi-square||||
1707414|NCT00876395|3141087|Superiority||Hazard Ratio (HR)|0.66||||0.0049|2-Sided|95.0|0.48|0.91|||Log Rank||||
1707415|NCT00876395|3141088|Superiority||Hazard Ratio (HR)|0.89||||0.1166|2-Sided|95.0|0.73|1.08|||Log Rank||||
1707416|NCT00876343|3141091|Superiority or Other||Mean Difference (Final Values)|-3.1|||<|0.001|2-Sided|95.0|-4.6|-1.5|||ANCOVA||||
1707417|NCT00876343|3141091|Superiority or Other||Mean Difference (Final Values)|-2.2|||<|0.006|2-Sided|95.0|-3.7|-0.6|||ANCOVA||||
1707418|NCT00876265|3141092|Non-Inferiority or Equivalence|If the 95% CI or the difference between LS mean (Belotero) and LS mean (Zyplast) lies entirely above –Δ, noninferiority of Belotero will be concluded (first step). If, in addition, the CI lies entirely above 0, superiority of Belotero over Zyplast will be concluded (second step).|Adjusted (LS) mean difference|0.048|Standard Error of the Mean|0.139||0.733|2-Sided|95.0|-0.228|0.323||Treatment term and all significant (p ≤ 0.10) covariate and covariate by treatment interactions will be retained in the final ANCOVA model. From the final ANCOVA model, adjusted (LS) means for Belotero and Zyplast was computed.|ANCOVA|||"The null, H0, and the alternative hypothesis, H1, are as follows:~H0(1): adjusted mean(dadj[i]) ≤ −Δ versus H1(1): adjusted mean(dadj[i]) > −Δ H0(2): adjusted mean(dadj[i]) ≤ 0 versus H1(2): adjusted mean(dadj[i]) > 0 The sample size calculation was based on the following assumptions: Type I error α = 0.025 (one sided); Power = 90%; Non-inferiority margin Δ = 0.25; Estimated common standard deviation (SD) = 0.75. Under these assumptions, a total of 100 evaluable subjects were needed."|
1707419|NCT00876018|3141112|Other|||||||0.678|||||||Mann Whitney U test||||
1707420|NCT00876018|3141112|Other|||||||0.143|||||||Mann Whitney U test||||
1707421|NCT00876018|3141113|Other|||||||0.903|||||||Mann Whitney U test||||
1707422|NCT00876018|3141113|Other|||||||0.153|||||||Mann Whitney U test||||
1707423|NCT00876018|3141114|Other|||||||0.003|||||||Mann Whitney U test||||
1707424|NCT00876018|3141114|Other|||||||0.002|||||||Mann Whitney U test||||
1707425|NCT00876018|3141115|Other|||||||0.147|||||||Mann Whitney U test||||
1707426|NCT00876018|3141115|Other|||||||0.004|||||||Mann Whitney U test||||
1707427|NCT00875797|3141126|Superiority or Other||percentage of survivers|80.0|||<|0.05||95.0||||p<0.05|Chi-squared, Corrected|2-degrees of freedom||Chi-square|
1707428|NCT00875797|3141127|Non-Inferiority or Equivalence|χ2 test|percentage of infection|20.0|Standard Deviation|10.0||0.05|2-Sided|95.0||||p<0.05|Chi-squared|2 degrees of freedom|||
1707429|NCT00875797|3141128|Non-Inferiority or Equivalence|t-test||||||0.05||||||p<0.05|t-test, 2 sided||||
1707430|NCT00875667|3141164|Superiority||Hazard Ratio (HR)|0.91||||0.558|2-Sided|95.0|0.67|1.25|||Log Rank||||
1707431|NCT00875667|3141165|Superiority||Hazard Ratio (HR)|0.89||||0.519|2-Sided|95.0|0.62|1.28|||Log Rank||||
1707432|NCT00875667|3141166|Superiority||Hazard Ratio (HR)|2.06|||<|0.004|2-Sided|95.0|1.24|3.42|||Log Rank||||
1707433|NCT00875667|3141167|Superiority||Hazard Ratio (HR)|3.91|||<|0.001|2-Sided|95.0|1.95|7.85|||Log Rank||||
1707434|NCT00875667|3141168|Superiority||Hazard Ratio (HR)|0.78||||0.095|2-Sided|95.0|0.58|1.05|||Log Rank||||
1707435|NCT00875667|3141169|Superiority||Hazard Ratio (HR)|0.74||||0.046|2-Sided|95.0|0.54|1.0|||Log Rank||||
1707436|NCT00875667|3141170|Superiority||Hazard Ratio (HR)|0.63||||0.003|2-Sided|95.0|0.46|0.86|||Log Rank||||
1707437|NCT00875667|3141171|Superiority||Hazard Ratio (HR)|0.62||||0.005|2-Sided|95.0|0.45|0.87|||Log Rank||||
1707438|NCT00875667|3141172|Superiority|||||||0.465|||||||Chi-squared||||
1707439|NCT00875667|3141173|Superiority|||||||0.313|||||||Chi-squared||||
1707440|NCT00875667|3141174|Superiority||Hazard Ratio (HR)|0.95||||0.875|2-Sided|95.0|0.52|1.74|||Log Rank||||
1707441|NCT00875667|3141175|Superiority||Hazard Ratio (HR)|0.7||||0.421|2-Sided|95.0|0.29|1.68|||Log Rank||||
1707442|NCT00875667|3141176|Superiority||||||<|0.001|||||||Chi-squared||||
1707443|NCT00875667|3141177|Superiority||||||<|0.001|||||||Chi-squared||||
1707444|NCT00875667|3141178|Superiority||Stratified Hazard Ratio|0.6||||0.003|2-Sided|95.0|0.43|0.85||Stratification factors were: time from diagnosis to first dose, time from last prior anti-lymphoma therapy to first dose, prior stem cell transplant, and MIPI at baseline|Stratified Log Rank Test||The weights are based on observed events at the time the third DMC meeting was held and based on the difference between observed and expected events at the time of the primary analysis.||
1707445|NCT00875667|3141179|Superiority||Stratified Hazard Ratio|0.63||||0.012|2-Sided|95.0|0.43|0.9||Stratification factors were: time from diagnosis to first dose, time from last prior anti-lymphoma therapy to first dose, prior stem cell transplant, and MIPI at baseline|Stratified Log Rank Test||||
1707598|NCT00873730|3141404|Superiority or Other|||||||0.6687|||||||Wilcoxon (Mann-Whitney)||||
1707446|NCT00875563|3141192|Non-Inferiority or Equivalence|An exact test method (Sidik K. 2003, Statistics in Medicine 22: 265-278) for matched controls was used, at a type I error rate of 0.05 and a non-inferiority margin of 10%. 38 pairs of patients were determined necessary, and the power was calculated to be 0.92.||||||0.02|||||||Exact test for matched pairs|||Patients treated with the Zenith® Fenestrated AAA Endovascular Graft were compared with matched patients treated with the Zenith® AAA Endovascular Graft.|
1707447|NCT00875277|3141263|Superiority|||||||0.089|||||||t-test, 2 sided||||
1707448|NCT00875277|3141263|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1707449|NCT00875277|3141263|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1707450|NCT00875277|3141263|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1707451|NCT00875277|3141263|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1707452|NCT00875277|3141263|Superiority||||||<|0.012|||||||t-test, 2 sided||||
1707453|NCT00875277|3141263|Superiority||||||<|0.009|||||||t-test, 2 sided||||
1707454|NCT00875277|3141263|Superiority||||||<|0.082|||||||t-test, 2 sided||||
1707455|NCT00875277|3141263|Superiority||||||<|0.035|||||||t-test, 2 sided||||
1707456|NCT00875277|3141263|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1707457|NCT00875277|3141263|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1707458|NCT00875277|3141263|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1707459|NCT00875277|3141263|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1707460|NCT00875277|3141263|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1707461|NCT00875277|3141263|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1707462|NCT00875212|3141264|Superiority or Other||Mean Difference (Final Values)|5.5|Standard Deviation|0.25||0.01||95.0|||||ANOVA|repeated measurements ANOVA|The difference of pH values between groups was above 1.0 unit.|The groups were compared by repeated measurements anova. There was no power calculation, but a pilot study to check the minimal number necessary of subjects in order to find a signifcant difference between interventions.|
1707463|NCT00875212|3141265|Superiority or Other||Median Difference (Final Values)|5.5|Standard Deviation|0.1||0.001||95.0|||||ANOVA|repeated-measurements ANOVA||The comparison was based on mean and median values of plaque pH in different moments of cariogenic challenge. The null hypothesis was that no diference between the groups wil be found. The test hypothesis was that the experimental dentifrice of CaGP-F would provide a better control of plaque pH after 14 days of use.|
1707464|NCT00875212|3141265|Superiority or Other||Median Difference (Final Values)|5.5|Standard Deviation|0.25||0.001||95.0|||||ANOVA|repeated measure anova|The median value of each parameter (pH baseline, minimal pH) was obtained and these values were compared between each group|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The null hyphothesis was no difference between pH values of the groups. The statistical analysis was by repeated measurements ANOVA.|
1707465|NCT00875017|3141266|Superiority or Other||LS Mean Difference|5.11||||0.612||95.0|-15.24|25.47|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.|
1707466|NCT00875017|3141266|Superiority or Other||LS Mean Difference|-15.56||||0.133||95.0|-36.11|4.99|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.|
1707467|NCT00875017|3141266|Superiority or Other||LS Mean Difference|-20.67||||0.049||95.0|-41.22|-0.13|||Mixed Models Analysis|||Net calcium absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.|
1707468|NCT00875017|3141267|Superiority or Other||LS Mean Difference|71.9|||<|0.001||95.0|40.03|103.77|||Mixed Models Analysis|||Phosphorus binding was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.|
1707469|NCT00875017|3141268|Superiority or Other||LS Mean Difference|-59.9|||<|0.001||95.0|-89.87|-29.93|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.|
1707470|NCT00875017|3141268|Superiority or Other||LS Mean Difference|-125.65|||<|0.001||95.0|-155.91|-95.39|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.|
1707471|NCT00875017|3141268|Superiority or Other||Least Squares (LS) Mean Difference|-65.75|||<|0.001||95.0|-96.01|-35.49|||Mixed Models Analysis|||Net phosphorus absorption was analysed using a mixed linear effect model with fixed effects for sequence group, period and treatment group. Subject within sequence effect was included as a random effect.|
1707472|NCT00874848|3141283|Superiority or Other|||||||0.2895|||||||Fisher Exact||||
1707473|NCT00874822|3141284|Superiority or Other||Percentage of Participants|19.0|Standard Error of the Mean|2.7|<|0.0001|2-Sided|95.0|13.6|24.4|||Chi-squared, Corrected|||"Ho: The Prevalence of obstructive sleep apnea in patients planning hip or knee arthroplasty will be no different using current screening techniques than it was in a historical control group.~The prevalence of OSA in the study population is hypothesized to be at least 10% higher than the best previous estimate of 6.7%. Employing a two-sided hypothesis test with α of 0.05 and power of 0.85 yields a sample size of 163."|
1707474|NCT00874731|3141292|Superiority or Other||Mean Difference (Final Values)|-1.5|||||2-Sided|95.0|-4.85|1.86|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.
1707475|NCT00874731|3141293|Superiority or Other||Mean Difference (Final Values)|3.89|||||2-Sided|95.0|0.6|7.17|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.
1707599|NCT00873730|3141405|Superiority or Other|||||||0.4969|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for the Patient Global Assessment.|
1707476|NCT00874731|3141294|Superiority or Other||Mean Difference (Final Values)|2.48|||||2-Sided|95.0|-0.8|5.76|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.
1707477|NCT00874731|3141295|Superiority or Other||Mean Difference (Final Values)|2.49|||||2-Sided|95.0|-0.79|5.78|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.
1707478|NCT00874731|3141296|Superiority or Other||Mean Difference (Final Values)|1.18|||||2-Sided|95.0|-2.1|4.47|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.
1707479|NCT00874731|3141297|Superiority or Other||Mean Difference (Final Values)|0.47|||||2-Sided|95.0|-2.85|3.79|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.
1707480|NCT00874731|3141298|Superiority or Other||Mean Difference (Final Values)|-1.18|||||2-Sided|95.0|-4.5|2.14|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.
1707481|NCT00874731|3141299|Superiority or Other||Mean Difference (Final Values)|-0.54|||||2-Sided|95.0|-3.83|2.74|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.
1707482|NCT00874731|3141302|Superiority or Other||Mean Difference (Final Values)|0.48|||||2-Sided|90.0|-2.8|3.76|||||Mean Difference in CFB = Ridaforolimus - Placebo||Mean difference and 90% confidence interval generated using a repeated measures mixed model that included treatment, time and treatment-by-time interaction as fixed factors and subject as random factor.
1707483|NCT00874497|3141323|Superiority or Other|||||||0.63||||||Fisher’s Exact test was used to determine whether the tetomilast and placebo groups differ in the proportion of participants who experienced Level 2 or higher COPD exacerbations during the study.|Fisher Exact|||Statistical analysis at Week 104|
1707484|NCT00874497|3141324|Superiority or Other|||||||0.5092|||||||Fisher Exact|||Statistical analysis for level III (hospital visit) at week 104.|
1707485|NCT00874497|3141324|Superiority or Other|||||||1|||||||Fisher Exact|||Statistical analysis for level II (physician visit) at week 104.|
1707486|NCT00874497|3141324|Superiority or Other|||||||1|||||||Fisher Exact|||Statistical analysis for level I (self management) at week 104.|
1707487|NCT00874497|3141326|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.717|2-Sided|95.0|-0.93|0.65|||ANCOVA|||Statistical analysis for mean prior daily sputum symptoms|
1707488|NCT00874497|3141326|Superiority or Other||Mean Difference (Final Values)|0.21||||0.549|2-Sided|95.0|-0.52|0.94|||ANCOVA|||Statistical analysis for mean prior daily cough symptoms|
1707489|NCT00874497|3141326|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.845|2-Sided|95.0|-0.77|0.64|||ANCOVA|||Statistical analysis for mean prior daily breath symptoms|
1707490|NCT00874497|3141327|Superiority or Other||Mean Difference (Final Values)|0.22||||0.155|2-Sided|95.0|-0.09|0.52|||ANCOVA|||Statistical analysis for sGaw|
1707491|NCT00874497|3141327|Superiority or Other||Mean Difference (Final Values)|-0.71||||0.074|2-Sided|95.0|-1.5|0.07|||ANCOVA|||Statistical analysis for sRaw|
1707492|NCT00874497|3141328|Superiority or Other||Mean Difference (Final Values)|0.6||||0.134|2-Sided|95.0|-0.19|1.4|||ANCOVA||||
1707493|NCT00874497|3141329|Superiority or Other||Mean Difference (Final Values)|-0.1835||||0.4661|2-Sided|95.0|-0.6892|0.3221|||ANCOVA||||
1707494|NCT00874497|3141330|Superiority or Other||Mean Difference (Final Values)|0.249||||0.1252|2-Sided|95.0|-0.073|0.571|||ANCOVA||||
1707495|NCT00874497|3141331|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.5843|2-Sided|95.0|-0.07|0.04|||ANCOVA||||
1707496|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|132.2||||0.524|2-Sided|95.0|-284.9|549.4|||ANCOVA|||Statistical analysis of whole lung region (TLC) at Week 104.|
1707497|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|64.9||||0.554|2-Sided|95.0|-155.5|285.3|||ANCOVA|||Statistical analysis of left whole lung region (TLC) at Week 104.|
1707498|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|62.2||||0.546|2-Sided|95.0|-145.1|269.5|||ANCOVA|||Statistical analysis of right whole lung region (TLC) at Week 104.|
1707499|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|23.3||||0.754|2-Sided|95.0|-126.0|172.6|||ANCOVA|||Statistical analysis of left lower lung region (TLC) at Week 104.|
1707500|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|51.5||||0.253|2-Sided|95.0|-38.4|141.4|||ANCOVA|||Statistical analysis of left upper lung region (TLC)at Week 104.|
1707501|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|10.7||||0.859|2-Sided|95.0|-110.7|132.1|||ANCOVA|||Statistical analysis of right lower lung region (TLC) at Week 104.|
1707502|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|9.9||||0.66|2-Sided|95.0|-35.3|55.0|||ANCOVA|||Statistical analysis of right middle lung region (TLC) at Week 104.|
1707503|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|50.7||||0.353|2-Sided|95.0|-58.5|159.9|||ANCOVA|||Statistical analysis of right upper lung region (TLC) at Week 104.|
1707504|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|187.6||||0.421|2-Sided|95.0|-279.6|654.8|||ANCOVA|||Statistical analysis of whole lung region (RV) at Week 104.|
1707505|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|85.2||||0.445|2-Sided|95.0|-138.8|309.2|||ANCOVA|||Statistical analysis of left whole lung region (RV) at Week 104.|
1707506|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|102.3||||0.408|2-Sided|95.0|-145.9|350.5|||ANCOVA|||Statistical analysis of right whole lung region (RV) at Week 104.|
1707508|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|62.6||||0.259|2-Sided|95.0|-48.1|173.2|||ANCOVA|||Statistical analysis of left upper lung region (RV) at Week 104.|
1707509|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|47.7||||0.445|2-Sided|95.0|-77.8|173.2|||ANCOVA|||Statistical analysis of right lower lung region (RV) at Week 104.|
1707510|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|-5.9||||0.781|2-Sided|95.0|-48.8|36.9|||ANCOVA|||Statistical analysis of right middle lung region (RV) at Week 104.|
1707511|NCT00874497|3141332|Superiority or Other||Mean Difference (Final Values)|77.9||||0.181|2-Sided|95.0|-38.0|193.8|||ANCOVA|||Statistical analysis of right upper lung region (RV) at Week 104.|
1707512|NCT00874497|3141333|Superiority or Other||Mean Difference (Final Values)|1156318.0||||0.251|2-Sided|95.0|-855009.0|3167645.0|||ANCOVA|||Statistical analysis of whole lung region of the lung at Week 104.|
1707513|NCT00874497|3141333|Superiority or Other||Mean Difference (Final Values)|589373.0||||0.247|2-Sided|95.0|-426928.0|1605673.0|||ANCOVA|||Statistical analysis of left whole region of the lung at Week 104.|
1707514|NCT00874497|3141333|Superiority or Other||Mean Difference (Final Values)|575882.0||||0.258|2-Sided|95.0|-439692.0|1591457.0|||ANCOVA|||Statistical analysis of right whole region of the lung at Week 104.|
1707515|NCT00874497|3141333|Superiority or Other||Mean Difference (Final Values)|294202.0||||0.325|2-Sided|95.0|-303329.0|891733.0|||ANCOVA|||Statistical analysis of left lower region of the lung at Week 104.|
1707516|NCT00874497|3141333|Superiority or Other||Mean Difference (Final Values)|362384.0||||0.141|2-Sided|95.0|-126518.0|851286.0|||ANCOVA|||Statistical analysis of left upper region of the lung at Week 104.|
1707517|NCT00874497|3141333|Superiority or Other||Mean Difference (Final Values)|247358.0||||0.322|2-Sided|95.0|-252728.0|747444.0|||ANCOVA|||Statistical analysis of right lower region of the lung at Week 104|
1707518|NCT00874497|3141333|Superiority or Other||Mean Difference (Final Values)|103036.0||||0.146|2-Sided|95.0|-37651.0|243723.0|||ANCOVA|||Statistical analysis of right middle region of the lung at Week 104|
1707519|NCT00874497|3141333|Superiority or Other||Mean Difference (Final Values)|351487.0||||0.22|2-Sided|95.0|-219976.0|922951.0|||ANCOVA|||Statistical analysis of right upper region of the lung at Week 104.|
1707520|NCT00874497|3141334|Superiority or Other||Mean Difference (Final Values)|-1.52||||0.438|2-Sided|95.0|-5.43|2.4|||ANCOVA|||Statistical analysis of whole region of the lung at Week 104.|
1707521|NCT00874497|3141334|Superiority or Other||Mean Difference (Final Values)|-1.93||||0.353|2-Sided|95.0|-6.09|2.23|||ANCOVA|||Statistical analysis of left whole region of the lung at Week 104.|
1707522|NCT00874497|3141334|Superiority or Other||Mean Difference (Final Values)|-1.27||||0.5|2-Sided|95.0|-5.03|2.5|||ANCOVA|||Statistical analysis of right whole region of the lung at Week 104.|
1707523|NCT00874497|3141334|Superiority or Other||Mean Difference (Final Values)|-0.83||||0.757|2-Sided|95.0|-6.26|4.59|||ANCOVA|||Statistical analysis of left lower region of the lung at Week 104.|
1707524|NCT00874497|3141334|Superiority or Other||Mean Difference (Final Values)|-2.94||||0.142|2-Sided|95.0|-6.92|1.03|||ANCOVA|||Statistical analysis of left upper region of the lung at Week 104.|
1707525|NCT00874497|3141334|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.598|2-Sided|95.0|-6.74|3.94|||ANCOVA|||Statistical analysis of right lower region of the lung at Week 104.|
1707526|NCT00874497|3141334|Superiority or Other||Mean Difference (Final Values)|-1.05||||0.463|2-Sided|95.0|-3.92|1.82|||ANCOVA|||Statistical analysis of right middle region of the lung at Week 104.|
1707527|NCT00874497|3141334|Superiority or Other||Mean Difference (Final Values)|-1.07||||0.519|2-Sided|95.0|-4.42|2.27|||ANCOVA|||Statistical analysis of right upper region of the lung at Week 104.|
1707528|NCT00874497|3141335|Superiority or Other||Mean Difference (Final Values)|-1.423||||0.469|2-Sided|95.0|-5.32|2.48|||ANCOVA|||LS Mean Difference between Tetomilast and Placebo at Week 104.|
1707529|NCT00874497|3141336|Superiority or Other||Mean Difference (Final Values)|2.05||||0.106|2-Sided|95.0|-0.46|4.56|||ANCOVA|||Statistical analysis of Whole Lung region of the Lung at Week 104.|
1707530|NCT00874497|3141336|Superiority or Other||Mean Difference (Final Values)|2.08||||0.122|2-Sided|95.0|-0.58|4.75|||ANCOVA|||Statistical analysis of Left Whole region of the Lung at Week 104.|
1707531|NCT00874497|3141336|Superiority or Other||Mean Difference (Final Values)|1.78||||0.16|2-Sided|95.0|-0.73|4.29|||ANCOVA|||Statistical analysis of Right Whole region of the Lung at Week 104.|
1707532|NCT00874497|3141336|Superiority or Other||Mean Difference (Final Values)|2.11||||0.162|2-Sided|95.0|-0.89|5.12|||ANCOVA|||Statistical analysis of Left Lower region of the Lung at Week 104.|
1707533|NCT00874497|3141336|Superiority or Other||Mean Difference (Final Values)|2.27||||0.102|2-Sided|95.0|-0.48|5.02|||ANCOVA|||Statistical analysis of Left Upper region of the Lung at Week 104.|
1707534|NCT00874497|3141336|Superiority or Other||Mean Difference (Final Values)|1.97||||0.163|2-Sided|95.0|-0.83|4.77|||ANCOVA|||Statistical analysis of Right Lower region of the Lung at Week 104.|
1707535|NCT00874497|3141336|Superiority or Other||Mean Difference (Final Values)|2.31||||0.067|2-Sided|95.0|-0.17|4.79|||ANCOVA|||Statistical analysis of Right Middle region of the Lung at Week 104.|
1707536|NCT00874497|3141336|Superiority or Other||Mean Difference (Final Values)|0.97||||0.436|2-Sided|95.0|-1.53|3.47|||ANCOVA|||Statistical analysis of Right Upper region of the Lung at Week 104.|
1707537|NCT00874497|3141338|Superiority or Other||Mean Difference (Final Values)|-1.374||||0.574|2-Sided|95.0|-6.23|3.48|||ANCOVA|||Statistical analysis of Left Whole region of the Lung at Week 104.|
1707538|NCT00874497|3141338|Superiority or Other||Mean Difference (Final Values)|-2.218||||0.244|2-Sided|95.0|-5.98|1.55|||ANCOVA|||Statistical analysis of Right Whole region of the Lung at Week 104.|
1707539|NCT00874497|3141338|Superiority or Other||Mean Difference (Final Values)|-1.225||||0.67|2-Sided|95.0|-6.94|4.48|||ANCOVA|||Statistical analysis of Left Lower region of the Lung at Week 104.|
1707540|NCT00874497|3141338|Superiority or Other||Mean Difference (Final Values)|-2.167||||0.362|2-Sided|95.0|-6.88|2.54|||ANCOVA|||Statistical analysis of Left Upper region of the Lung at Week 104.|
1707600|NCT00873730|3141405|Superiority or Other|||||||0.9426|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for the Physician Global Assessment.|
1707541|NCT00874497|3141338|Superiority or Other||Mean Difference (Final Values)|-2.176||||0.457|2-Sided|95.0|-7.98|3.63|||ANCOVA|||Statistical analysis of Right Lower region of the Lung at Week 104.|
1707542|NCT00874497|3141338|Superiority or Other||Mean Difference (Final Values)|-1.21||||0.46|2-Sided|95.0|-4.46|2.04|||ANCOVA|||Statistical analysis of Right Middle region of the Lung at Week 104.|
1707543|NCT00874497|3141338|Superiority or Other||Mean Difference (Final Values)|-2.904||||0.139|2-Sided|95.0|-6.77|0.97|||ANCOVA|||Statistical analysis of Right Upper region of the lung at Week 104.|
1707544|NCT00874497|3141339|Superiority or Other||Mean Difference (Final Values)|0.0824||||0.1761|2-Sided|95.0|-0.0378|0.2025||P-values are based on Analysis of Covariance (ANCOVA) model of the change FEV1 from baseline to the specified study week using treatment group and current smoking status as fixed effects and the baseline FEV1 value as a covariate.|ANCOVA|||Statistical analysis at Week 104.|
1707545|NCT00874276|3141340|Superiority or Other||Kendall's Tau B|-0.23|Standard Error of the Mean|0.23||0.42|2-Sided|95.0|-0.23|0.69|||Wilcoxon (Mann-Whitney)|||This is the same analysis as the previous, except we use the day 5 pharmacogenetics on the amount of time needed to clear one-half of dose of the drug. This is for the environmental dose. A positive (negative) Kendall's Tau is associated with the EGT allele being faster (slower) than lacking EGT in terms of metabolization of DCA.|
1707546|NCT00874276|3141341|Superiority or Other||Kendall's Tau-B|0.6|Standard Error of the Mean|0.127||0.023|2-Sided|95.0|0.35|0.85||This is the primary outcome, and there is no adjustment.|Wilcoxon (Mann-Whitney)|||We used a Wilcoxon test (and accompanying Kendal's Tau B) because these outcomes are outlier prone.|
1707547|NCT00874250|3141350|Superiority or Other||Proportion|0.98||||0.0024|2-Sided|95.0|0.895|0.996|||Binomial Test||||
1707548|NCT00874120|3141358|Superiority or Other||residual error term from the ANOVA|-0.5||||0.548|2-Sided|95.0|-2.0|1.1||P-value is based on an ANOVA model including sequence, subject within sequence, period and treatment as factors.|ANOVA||||
1707549|NCT00873912|3141374|Non-Inferiority or Equivalence|Based on similar fever rate with 300 evaluable subjects (240 vaccine and 60 placebo recipients), the study would provide at least 98% power to rule out a rate increase of 5 percentage points assuming the true difference between the treatment groups is zero and the true fever rate is ≤ 1.0%. Power would be lower if the true difference was different from zero.|rate difference|-1.3|||||2-Sided|95.0|-7.9|1.3||||||The percentage of subjects with fever was compared between the two treatment groups based on the upper limit of the two-sided 95% CIs for rate difference (monovalent vaccine minus placebo). The upper limit of the two-sided 95% CI was evaluated against the pre-specified equivalence criterion of 5 percentage points which corresponded to the following hypotheses: - H0 (null): rate difference ≥ 5 percentage points, - HA (alternative): rate difference < 5 percentage points.|
1707550|NCT00873873|3141376|Superiority or Other|||||||0.2|||||||ANOVA|||Is there a difference in airway wall thickness among the 4 groups?|
1707551|NCT00873860|3141377|Superiority or Other|||||||0.688||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank||||
1707552|NCT00873860|3141377|Superiority or Other|||||||0.992||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank||||
1707553|NCT00873860|3141377|Superiority or Other|||||||0.987||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank||||
1707554|NCT00873860|3141377|Superiority or Other|||||||0.847||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank||||
1707555|NCT00873860|3141377|Superiority or Other|||||||0.534||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank||||
1707556|NCT00873860|3141377|Superiority or Other|||||||0.546||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank||||
1707557|NCT00873860|3141378|Superiority or Other|||||||0.673||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test||||
1707558|NCT00873860|3141378|Superiority or Other|||||||0.9||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test||||
1707559|NCT00873860|3141378|Superiority or Other|||||||0.991||||||Day 1 to 169: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test||||
1707560|NCT00873860|3141378|Superiority or Other|||||||0.983||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test||||
1707561|NCT00873860|3141378|Superiority or Other|||||||0.492||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test||||
1707562|NCT00873860|3141378|Superiority or Other|||||||0.551||||||Day 1 to 92: P-value was calculated against placebo group from Van Elteren Test.|Van Elteren Test||||
1707563|NCT00873860|3141379|Superiority or Other|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact||||
1707564|NCT00873860|3141379|Superiority or Other|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact||||
1707565|NCT00873860|3141379|Superiority or Other|||||||1||||||Day 169: Fisher exact test was used for the analysis.|Fisher Exact||||
1707566|NCT00873860|3141379|Superiority or Other|||||||1||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact||||
1707567|NCT00873860|3141379|Superiority or Other|||||||0.6022||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact||||
1707568|NCT00873860|3141379|Superiority or Other|||||||1||||||Day 92: Fisher exact test was used for the analysis.|Fisher Exact||||
1707569|NCT00873860|3141384|Superiority or Other|||||||0.592||||||ACQ score <=0.75, Day 169: Fisher exact test was used to compare all arms.|Fisher Exact||||
1707570|NCT00873860|3141384|Superiority or Other|||||||0.934||||||ACQ score <=0.75, Day 92: Fisher exact test was used to compare all arms.|Fisher Exact||||
1709144|NCT00852995|3144527|Superiority or Other|||||||0.758||||||Visit 13|Cochran-Mantel-Haenszel||||
1707571|NCT00873860|3141391|Superiority or Other|||||||0.2108||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score >= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.|
1707572|NCT00873860|3141391|Superiority or Other|||||||0.3133||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score >= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.|
1707573|NCT00873860|3141391|Superiority or Other|||||||0.3234||||||Day 1 to 169: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score >= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.|
1707574|NCT00873860|3141391|Superiority or Other|||||||0.1664||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score >= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.|
1707575|NCT00873860|3141391|Superiority or Other|||||||0.317||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score >= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.|
1707576|NCT00873860|3141391|Superiority or Other|||||||0.4686||||||Day 1 to 92: P-value was calculated against placebo group from a stratified log-rank test with atopic asthma status and tertile of baseline mean ACQ score as the stratification factors.|Log Rank|||P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score >= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.|
1707577|NCT00873860|3141392|Superiority or Other|||||||0.224||||||Change at Day 92: p-value was based on ANOVA.|ANOVA||||
1707578|NCT00873860|3141392|Superiority or Other|||||||0.64||||||Change at Day 92: p-value was based on ANOVA.|ANOVA||||
1707579|NCT00873860|3141392|Superiority or Other|||||||0.573||||||Change at Day 92: p-value was based on analysis of variance (ANOVA).|ANOVA||||
1707580|NCT00873821|3141393|Superiority or Other||Mean Difference (Final Values)|40.83|||<|0.001|2-Sided|95.0|26.33|55.32|||Mixed Models Analysis|||Difference (placebo minus MK-0941) in change from baseline to Day 13|
1707581|NCT00873730|3141397|Superiority or Other|||||||0.7404|||||||Wilcoxon (Mann-Whitney)||||
1707582|NCT00873730|3141399|Superiority or Other|||||||0.7125|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Mental health.|
1707583|NCT00873730|3141399|Superiority or Other|||||||0.7998|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Emotional role limitations.|
1707584|NCT00873730|3141399|Superiority or Other|||||||0.8334|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Social functioning.|
1707585|NCT00873730|3141399|Superiority or Other|||||||0.3327|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Vitality.|
1707586|NCT00873730|3141399|Superiority or Other|||||||0.3123|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for General health.|
1707587|NCT00873730|3141399|Superiority or Other|||||||0.8558|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Bodily pain.|
1707588|NCT00873730|3141399|Superiority or Other|||||||0.9045|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Physical role limitations.|
1707589|NCT00873730|3141399|Superiority or Other|||||||0.3476|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Physical functioning.|
1707590|NCT00873730|3141400|Superiority or Other|||||||0.562|||||||Chi-squared|||Analysis provided for Anxiety/Depression.|
1707591|NCT00873730|3141400|Superiority or Other|||||||0.0461|||||||Chi-squared|||Analysis provided for Pain/Discomfort.|
1707592|NCT00873730|3141400|Superiority or Other|||||||0.429|||||||Chi-squared|||Analysis provided for Usual activities.|
1707593|NCT00873730|3141400|Superiority or Other|||||||0.8009|||||||Chi-squared|||Analysis provided for Self-care.|
1707594|NCT00873730|3141400|Superiority or Other|||||||0.2099|||||||Chi-squared|||Analysis provided for Mobility.|
1707595|NCT00873730|3141401|Superiority or Other|||||||0.156|||||||Wilcoxon (Mann-Whitney)||||
1707596|NCT00873730|3141402|Superiority or Other|||||||0.2772|||||||Wilcoxon (Mann-Whitney)||||
1707597|NCT00873730|3141403|Superiority or Other|||||||0.6739|||||||Wilcoxon (Mann-Whitney)||||
1707602|NCT00873730|3141406|Superiority or Other|||||||0.666|||||||Wilcoxon (Mann-Whitney)|||Analysis provided for Nocturnal Back Pain.|
1707603|NCT00873730|3141407|Superiority or Other|||||||0.7721|||||||Chi-squared||||
1707604|NCT00873730|3141408|Superiority or Other|||||||0.7481|||||||Chi-squared||||
1707605|NCT00873730|3141409|Superiority or Other|||||||0.3266|||||||Chi-squared||||
1707606|NCT00873730|3141410|Superiority or Other|||||||0.7564|||||||Chi-squared||||
1707607|NCT00873730|3141411|Superiority or Other|||||||0.9166|||||||Chi-squared||||
1707608|NCT00873730|3141412|Superiority or Other|||||||0.6031|||||||Chi-squared||||
1707609|NCT00872989|3141478|Superiority or Other||Hazard Ratio (HR)|1.25||||0.83|2-Sided|80.0|0.93|1.68|||Regression, Cox||||
1707610|NCT00872989|3141480|Superiority or Other||Hazard Ratio (HR)|0.99||||0.49|2-Sided|80.0|0.79|1.26|||Regression, Cox||||
1707611|NCT00872898|3141481|Superiority or Other||Least squares mean difference|0.0||||0.95|2-Sided|95.0|-1.2|1.1|||mixed-model for repeated measures||||
1707612|NCT00872898|3141482|Superiority or Other||Least squares mean difference|0.2||||0.7481|2-Sided|95.0|-0.9|1.2|||mixed-model for repeated measures||||
1707613|NCT00872898|3141483|Superiority or Other||Least squares mean difference|-0.2||||0.6889|2-Sided|95.0|-1.3|0.9|||mixed-model for repeated measures||||
1707614|NCT00872898|3141484|Superiority or Other||Least squares mean difference|1.4||||0.0201|2-Sided|95.0|0.2|2.5|||mixed-model for repeated measures||||
1707615|NCT00872898|3141485|Superiority or Other||Least squares mean difference|0.5||||0.4228|2-Sided|95.0|-0.7|1.6|||mixed-model for repeated measures||||
1707616|NCT00872898|3141486|Superiority or Other||Least squares mean difference|0.0||||0.9898|2-Sided|95.0|-1.3|1.3|||mixed-model for repeated measures||||
1707617|NCT00872898|3141487|Superiority or Other||Least squares mean difference|0.0||||0.9598|2-Sided|95.0|-1.3|1.3|||mixed-model for repeated measures||||
1707618|NCT00872898|3141488|Superiority or Other||Least squares mean difference|-0.3||||0.4679|2-Sided|95.0|-1.2|0.6|||mixed-model for repeated measures||||
1707619|NCT00872898|3141489|Superiority or Other||Least squares mean difference|-0.1||||0.9069|2-Sided|95.0|-1.3|1.1|||mixed-model for repeated measures||||
1707620|NCT00872898|3141490|Superiority or Other||Least squares mean difference|-0.2||||0.7|2-Sided|95.0|-1.5|1.0|||mixed-model for repeated measures||||
1707621|NCT00872898|3141491|Superiority or Other||Least squares mean difference|-0.8||||0.1344|2-Sided|95.0|-1.9|0.3|||mixed-model for repeated measures||||
1707622|NCT00872898|3141492|Superiority or Other||Least squares mean difference|-1.4||||0.1459|2-Sided|95.0|-3.2|0.5|||mixed-model for repeated measures||||
1707623|NCT00872898|3141493|Superiority or Other||Least squares mean difference|-0.1||||0.9781|2-Sided|95.0|-7.2|7.0|||mixed-model for repeated measures||||
1707624|NCT00872898|3141494|Superiority or Other||Least squares mean difference|-2.2||||0.1197|2-Sided|95.0|-4.9|0.6|||mixed-model for repeated measures||||
1707625|NCT00872833|3141496|Superiority or Other|||||||0.028|||||||Chi-squared||||
1707626|NCT00872833|3141497|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1707627|NCT00872521|3141514|Superiority or Other|||||||0.28|||||||Log Rank|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified|
1707628|NCT00872521|3141515|Superiority or Other|||||||0.01|||||||Log Rank|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified|
1707629|NCT00872521|3141516|Superiority or Other|||||||0.56|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified|
1707630|NCT00872521|3141517|Superiority or Other|||||||0.23|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified|
1707631|NCT00872521|3141518|Superiority or Other|||||||0.23|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified|
1707632|NCT00872521|3141519|Superiority or Other|||||||0.09|||||||Chi-squared|||Null Hypothesis: There is no difference in response rate between 1q21 amplified and 1q21 NOT amplified|
1707633|NCT00872430|3141520|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||All data were collected and entered before the opening of the codes of blinding of researchers. We used t test for paired samples and test for repeated measures linear regression for variables with more than two measures.With an improvement of 40% in the tea group and of 20% in the placebo group, with a power (1-ß) of 80% and a alpha error 0.05, it was necessary to include 32 points of comparison, which would be achieved with at least 16 patients, since it's a crossover study.|
1707634|NCT00872430|3141521|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1707635|NCT00872339|3141523|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1707636|NCT00872339|3141525|Superiority or Other|||||||0.45|||||||Chi-squared||||
1707637|NCT00872170|3141526|Superiority or Other|||||||0.96|||||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.|||
1707638|NCT00872170|3141527|Superiority or Other|||||||0.97|||||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.|||
1707639|NCT00872170|3141528|Superiority or Other|||||||0.18|||||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.|||
1707640|NCT00872170|3141529|Superiority or Other|||||||0.33|||||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.|||
1707641|NCT00872170|3141530|Superiority or Other|||||||0.04|||||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.|||
1707642|NCT00872170|3141531|Superiority or Other|||||||0.02|||||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.|||
1707643|NCT00872170|3141532|Superiority or Other|||||||0.05|||||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.|||
1709145|NCT00852995|3144527|Superiority or Other|||||||0.7735||||||Visit 13|Cochran-Mantel-Haenszel||||
1707644|NCT00872170|3141533|Superiority or Other|||||||0.02|||||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.|||
1707645|NCT00872170|3141534|Superiority or Other|||||||0.005|||||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.|||
1707646|NCT00872170|3141535|Superiority or Other|||||||0.04|||||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.|||
1707647|NCT00872170|3141536|Superiority or Other|||||||0.97|||||||Mixed Models Analysis|Linear mixed models with participant-specific intercepts and slopes controlled for time effects were used.||This study had 80% power at level alpha=0.05 to detect a 60 m change in 6MWT among N=10 participants, assuming a 60 m standard deviation for 12-week change.|
1707648|NCT00871975|3141541|Superiority or Other||Specificity (percent)|28.1|||||2-Sided||||||||We found a 28.1% specificity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.|A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.|
1707649|NCT00871975|3141541|Superiority or Other||Sensitivity (percent)|80.6|||||2-Sided||||||||We found an 80.6% sensitivity for detection of detrusor overactivity on Tetra-NIRS as compared to urodynamics.|A contingency table was used to compare presence or absence of an event (eg. detrusor overactivity) on the urodynamic tracing with interpretation of events on the Tetra-NIRS tracings.|
1707650|NCT00871871|3141542|Superiority or Other||Least squares mean difference|0.003|||>|0.5|2-Sided|90.0|-0.003|0.01|||ANOVA||||
1707651|NCT00871871|3141543|Superiority or Other||Least squares mean difference|0.0016|||>|0.5|2-Sided|90.0|-0.008|0.011|||ANOVA||||
1707652|NCT00871871|3141544|Superiority or Other||Least squares mean difference|0.004||||0.342|2-Sided|90.0|-0.023|0.014||one-sided, alpha = 0.05|ANOVA||||
1707653|NCT00871871|3141545|Superiority or Other||Least squares mean difference|0.54|||>|0.5|2-Sided|90.0|0.4|0.67|||ANCOVA||||
1707654|NCT00871871|3141546|Superiority or Other||Least squares mean difference|0.016||||0.13|2-Sided|90.0|-0.012|0.044||one-sided, alpha = 0.05|ANOVA||||
1707655|NCT00871871|3141547|Superiority or Other||Least squares mean difference|1.1|||>|0.5|2-Sided|90.0|0.86|1.34|||ANCOVA||||
1707656|NCT00871871|3141548|Superiority or Other||Least squares mean difference|-0.1||||0.067|2-Sided|90.0|-0.22|0.01||one-sided, alpha = 0.05|ANCOVA||||
1707657|NCT00871780|3141554|Superiority or Other||||||<|0.0001|||||||Spearman correlation|||Change from Baseline at Week 48|
1707658|NCT00871780|3141554|Superiority or Other||||||<|0.0001|||||||Spearman correlation|||Change from Baseline at Week 24|
1707659|NCT00871780|3141554|Superiority or Other||||||<|0.0001|||||||Spearman correlation|||Baseline|
1707660|NCT00871780|3141555|Superiority or Other|||||||0.0866|||||||Pearson Correlation|||Change from Baseline at Week 48|
1707661|NCT00871780|3141555|Superiority or Other|||||||0.0016|||||||Pearson Correlation|||Change from Baseline at Week 24|
1707662|NCT00871780|3141555|Superiority or Other||||||<|0.0001|||||||Pearson Correlation|||Baseline|
1707663|NCT00871780|3141556|Superiority or Other||||||<|0.0001|||||||Spearman correlation|||Change from Baseline at Week 48|
1707664|NCT00871780|3141556|Superiority or Other||||||<|0.0001|||||||Spearman correlation|||Change from Baseline at Week 24|
1707665|NCT00871780|3141556|Superiority or Other||||||<|0.0001|||||||Spearman correlation|||Baseline|
1707666|NCT00871780|3141557|Superiority or Other||||||<|0.0001|||||||Pearson Correlation|||Change from Baseline at Week 48|
1707667|NCT00871780|3141557|Superiority or Other||||||<|0.0001|||||||Pearson Correlation|||Change from Baseline at Week 24|
1707668|NCT00871780|3141557|Superiority or Other||||||<|0.0001|||||||Pearson Correlation|||Baseline|
1707669|NCT00871780|3141558|Superiority or Other||||||<|0.0001|||||||Spearman correlation|||Change from Baseline at Week 48|
1707670|NCT00871780|3141558|Superiority or Other||||||<|0.0001|||||||Spearman correlation|||Change from Baseline at Week 24|
1707671|NCT00871780|3141558|Superiority or Other||||||<|0.0001|||||||Spearman correlation|||Baseline|
1707672|NCT00871780|3141559|Superiority or Other||||||<|0.0001|||||||Pearson Correlation|||Change from Baseline at Week 48|
1707673|NCT00871780|3141559|Superiority or Other||||||<|0.0001|||||||Pearson Correlation|||Change from Baseline at Week 24|
1707674|NCT00871780|3141559|Superiority or Other||||||<|0.0001|||||||Pearson Correlation|||Baseline|
1707675|NCT00871780|3141560|Superiority or Other||||||<|0.0001|||||||Spearman correlation|||Change from Baseline at Week 48|
1707676|NCT00871780|3141560|Superiority or Other||||||<|0.0001|||||||Spearman correlation|||Change from Baseline at Week 24|
1707677|NCT00871780|3141560|Superiority or Other||||||<|0.0001|||||||Spearman correlation|||Baseline|
1707678|NCT00871780|3141561|Superiority or Other||||||<|0.0001|||||||Pearson Correlation|||Change from Baseline at Week 48|
1707679|NCT00871780|3141561|Superiority or Other||||||<|0.0001|||||||Pearson Correlation|||Change from Baseline at Week 24|
1707680|NCT00871780|3141561|Superiority or Other||||||<|0.0001|||||||Pearson Correlation|||Baseline|
1707681|NCT00871780|3141562|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed rank test|||Baseline, Week 48|
1707682|NCT00871780|3141562|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed rank test|||Baseline, Week 24|
1707683|NCT00871780|3141563|Superiority or Other|||||||0.0157|||||||Wilcoxon signed rank test|||Baseline, Week 48|
1707684|NCT00871780|3141563|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed rank test|||Baseline, Week 24|
1707685|NCT00871780|3141564|Superiority or Other|||||||0.0119|||||||Wilcoxon signed rank test|||Baseline, Week 48|
1707686|NCT00871780|3141564|Superiority or Other|||||||0.0148|||||||Wilcoxon signed rank test|||Baseline, Week 24|
1707687|NCT00871780|3141565|Superiority or Other|||||||0.0002|||||||Wilcoxon signed rank test|||Baseline, Week 48|
1707688|NCT00871780|3141565|Superiority or Other|||||||0.0003|||||||Wilcoxon signed rank test|||Baseline, Week 24|
1707689|NCT00871624|3141621|Other|||||||0.3|||||||Chi-squared||||
1708393|NCT00858208|3143286|Superiority or Other|||||||0.7765|||||||paired t-test|||Change from baseline at Week 66|
1707690|NCT00871624|3141622|Non-Inferiority or Equivalence|A difference in the mean four-point NIV intolerance score of 1 over the course of the study or between groups was considered through investigator consensus to be clinically meaningful. Assuming that the SD of NIV intolerance scores was 1 and that an alpha of 0.05 would be used for testing, it was determined that 18 subjects were needed in each group to achieve an 80% power.|Odds Ratio (OR)|1.44||||0.54|2-Sided|95.0|0.44|4.7|||Chi-squared||||
1707691|NCT00871572|3141623|Superiority or Other||Mean Difference (Final Values)|0.1||||0.726|2-Sided|95.0|-0.5|0.7|||ANCOVA||||
1707692|NCT00871572|3141623|Superiority or Other||Mean Difference (Final Values)|0.0||||0.864|2-Sided|95.0|-0.5|0.6|||ANCOVA||||
1707693|NCT00871572|3141623|Superiority or Other||Mean Difference (Final Values)|0.0||||0.919|2-Sided|95.0|-0.6|0.6|||ANCOVA||||
1707694|NCT00871572|3141624|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.634|2-Sided|95.0|-0.7|0.4|||ANCOVA||||
1707695|NCT00871572|3141624|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.476|2-Sided|95.0|-0.7|0.3|||ANCOVA||||
1707696|NCT00871572|3141624|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.523|2-Sided|95.0|-0.8|0.4|||ANCOVA||||
1707697|NCT00871572|3141625|Superiority or Other||Mean Difference (Final Values)|0.1||||0.297|2-Sided|95.0|-0.1|0.4|||ANCOVA||||
1707698|NCT00871572|3141625|Superiority or Other||Mean Difference (Final Values)|0.2||||0.191|2-Sided|95.0|-0.1|0.4|||ANCOVA||||
1707699|NCT00871572|3141625|Superiority or Other||Mean Difference (Final Values)|0.1||||0.365|2-Sided|95.0|-0.1|0.4|||ANCOVA||||
1707700|NCT00871572|3141626|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.657|2-Sided|95.0|-0.6|0.4|||ANCOVA||||
1707701|NCT00871572|3141626|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.426|2-Sided|95.0|-0.7|0.3|||ANCOVA||||
1707702|NCT00871572|3141626|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.584|2-Sided|95.0|-0.7|0.4|||ANCOVA||||
1707703|NCT00871572|3141627|Superiority or Other||Mean Difference (Final Values)|36218.98||||0.285|2-Sided|95.0|-30955.5|103393.46|||ANCOVA||||
1707704|NCT00871572|3141627|Superiority or Other||Mean Difference (Final Values)|5783.59||||0.8581|2-Sided|95.0|-58650.71|70217.89|||ANCOVA||||
1707705|NCT00871572|3141627|Superiority or Other||Mean Difference (Final Values)|18094.32||||0.6209|2-Sided|95.0|-54734.08|90922.71|||ANCOVA||||
1707706|NCT00871572|3141628|Superiority or Other||Mean Difference (Final Values)|18153.92||||0.0653|2-Sided|95.0|-1188.23|37496.06|||ANCOVA||||
1707707|NCT00871572|3141628|Superiority or Other||Mean Difference (Final Values)|5174.85||||0.5739|2-Sided|95.0|-13158.65|23508.35|||ANCOVA||||
1707708|NCT00871572|3141628|Superiority or Other||Mean Difference (Final Values)|8018.51||||0.45|2-Sided|95.0|-13104.14|29141.16|||ANCOVA||||
1707709|NCT00871572|3141629|Superiority or Other||Mean Difference (Final Values)|1.71||||0.1564|2-Sided|95.0|-0.67|4.1|||Mixed Models Analysis||||
1707710|NCT00871572|3141629|Superiority or Other||Mean Difference (Final Values)|2.03||||0.0791|2-Sided|95.0|-0.24|4.31|||Mixed Models Analysis||||
1707711|NCT00871572|3141629|Superiority or Other||Mean Difference (Final Values)|1.87||||0.1596|2-Sided|95.0|-0.75|4.49|||Mixed Models Analysis||||
1707712|NCT00871572|3141630|Superiority or Other||Mean Difference (Final Values)|107.26||||0.0101|2-Sided|95.0|26.29|188.22|||Mixed Models Analysis||||
1707713|NCT00871572|3141630|Superiority or Other||Mean Difference (Final Values)|89.68||||0.022|2-Sided|95.0|13.27|166.1|||Mixed Models Analysis||||
1707714|NCT00871572|3141630|Superiority or Other||Mean Difference (Final Values)|55.06||||0.2131|2-Sided|95.0|-32.24|142.37|||Mixed Models Analysis||||
1707715|NCT00871572|3141631|Superiority or Other||Mean Difference (Final Values)|24.25||||0.3658|2-Sided|95.0|-28.93|77.44|||Mixed Models Analysis||||
1707716|NCT00871572|3141631|Superiority or Other||Mean Difference (Final Values)|5.4||||0.8315|2-Sided|95.0|-45.12|55.93|||Mixed Models Analysis||||
1707717|NCT00871572|3141631|Superiority or Other||Mean Difference (Final Values)|25.62||||0.3815|2-Sided|95.0|-32.44|83.68|||Mixed Models Analysis||||
1707718|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-42.07||||0.0029|2-Sided|95.0|-69.13|-15.01||P-value is for Bedtime.|Mixed Models Analysis||||
1707719|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-46.5||||0.0006|2-Sided|95.0|-71.93|-21.07||P-value is for Bedtime.|Mixed Models Analysis||||
1707720|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-36.88||||0.0154|2-Sided|95.0|-66.43|-7.33||P-value is for Bedtime.|Mixed Models Analysis||||
1707721|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-39.56||||0.0065|2-Sided|95.0|-67.63|-11.48||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis||||
1707722|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-43.8||||0.0016|2-Sided|95.0|-70.42|-17.18||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis||||
1707723|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-39.82||||0.0118|2-Sided|95.0|-70.51|-9.13||P-value is for 2 Hours After Evening Meal.|Mixed Models Analysis||||
1707724|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-46.19||||0.0013|2-Sided|95.0|-73.57|-18.81||P-value is for Pre Evening Meal.|Mixed Models Analysis||||
1707725|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-54.45|||<|0.0001|2-Sided|95.0|-80.42|-28.48||P-value is for Pre Evening Meal.|Mixed Models Analysis||||
1707726|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-44.78|||<|0.0041|2-Sided|95.0|-74.79|-14.77||P-value is for Pre Evening Meal.|Mixed Models Analysis||||
1707727|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-22.56|||<|0.0729|2-Sided|95.0|-47.28|2.16||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis||||
1707728|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-15.65|||<|0.1896|2-Sided|95.0|-39.24|7.94||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis||||
1707729|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-28.48|||<|0.0389|2-Sided|95.0|-55.47|-1.49||P-value is for 2 Hours After Mid-Day Meal.|Mixed Models Analysis||||
1708394|NCT00858208|3143286|Superiority or Other|||||||0.434|||||||paired t-test|||Change from baseline at Week 60|
1707730|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-37.87|||<|0.0011|2-Sided|95.0|-59.98|-15.75||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis||||
1707731|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-33.15|||<|0.0024|2-Sided|95.0|-54.1|-12.21||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis||||
1707732|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-35.81|||<|0.0045|2-Sided|95.0|-60.1|-11.53||P-value is for Pre-Mid-Day Meal.|Mixed Models Analysis||||
1707733|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-7.2|||<|0.5774|2-Sided|95.0|-32.9|18.49||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis||||
1707734|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-8.2|||<|0.5045|2-Sided|95.0|-32.61|16.21||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis||||
1707735|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-6.42|||<|0.6513|2-Sided|95.0|-34.66|21.82||P-value is for 2 Hours After Morning Meal.|Mixed Models Analysis||||
1707736|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-39.32|||<|0.0001|2-Sided|95.0|-58.12|-20.53||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis||||
1707737|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-35.28|||<|0.0002|2-Sided|95.0|-53.08|-17.48||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis||||
1707738|NCT00871572|3141632|Superiority or Other||Mean Difference (Final Values)|-23.56|||<|0.0248|2-Sided|95.0|-44.03|-3.09||P-value is for Pre-Morning Meal (fasting).|Mixed Models Analysis||||
1707739|NCT00871572|3141635|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.715|2-Sided|95.0|-0.7|0.5|||ANCOVA||||
1707740|NCT00871572|3141635|Superiority or Other||Mean Difference (Final Values)|0.1||||0.681|2-Sided|95.0|-0.4|0.7|||ANCOVA||||
1707741|NCT00871572|3141635|Superiority or Other||Mean Difference (Final Values)|0.1||||0.814|2-Sided|95.0|-0.5|0.7|||ANCOVA||||
1707742|NCT00871572|3141636|Superiority or Other||Mean Difference (Final Values)|-466.83||||0.0068|2-Sided|95.0|-799.48|-134.18|||ANCOVA||||
1707743|NCT00871572|3141636|Superiority or Other||Mean Difference (Final Values)|-338.64||||0.0372|2-Sided|95.0|-656.55|-20.72|||ANCOVA||||
1707744|NCT00871572|3141636|Superiority or Other||Mean Difference (Final Values)|-124.56||||0.4978|2-Sided|95.0|-490.02|240.9|||ANCOVA||||
1707745|NCT00871572|3141637|Superiority or Other||Mean Difference (Final Values)|-2.41||||0.0594|2-Sided|95.0|-4.92|0.1|||Mixed Models Analysis||||
1707746|NCT00871572|3141637|Superiority or Other||Mean Difference (Final Values)|-1.86||||0.1245|2-Sided|95.0|-4.25|0.53|||Mixed Models Analysis||||
1707747|NCT00871572|3141637|Superiority or Other||Mean Difference (Final Values)|-1.62||||0.2565|2-Sided|95.0|-4.46|1.21|||Mixed Models Analysis||||
1707748|NCT00871572|3141638|Superiority or Other||Mean Difference (Final Values)|-0.76||||0.0514|2-Sided|90.0|-1.41|-0.12|||Mixed Models Analysis||||
1707749|NCT00871572|3141638|Superiority or Other||Mean Difference (Final Values)|-0.76||||0.0418|2-Sided|90.0|-1.37|-0.15|||Mixed Models Analysis||||
1707750|NCT00871572|3141638|Superiority or Other||Mean Difference (Final Values)|-0.94||||0.0296|2-Sided|90.0|-1.64|-0.23|||Mixed Models Analysis||||
1707751|NCT00871403|3141645|Superiority or Other||percent difference in response|-12.0||||0.2113|2-Sided|95.0|-30.6|7.2|||Binomial asymptotic||The estimated value is the percent difference in the response rate comparing Pazopanib 800 mg plus pemetrexed 500 mg/m^2 to Cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2.||
1707752|NCT00871403|3141648|Superiority or Other||Hazard Ratio (HR)|0.75||||0.2647|2-Sided|95.0|0.43|1.28|||Log Rank||The hazard ratios is estimated using a Pike estimator. The estimated value is the hazard ratio comparing Pazopanib 800 mg plus pemetrexed 500 mg/m^2 to Cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2.||
1707753|NCT00871351|3141653|Superiority or Other||||||<|0.0001|||||||Hochberg's method||||
1707754|NCT00871351|3141653|Superiority or Other||||||<|0.0003|||||||Hochberg's method||||
1707755|NCT00871351|3141654|Superiority or Other||Mean Difference (Net)|-26.5|||<|0.0001|2-Sided|95.0|-31.8|-21.2|||Hochberg's method||||
1707756|NCT00871351|3141654|Superiority or Other||Mean Difference (Net)|-10.6|||<|0.0001|2-Sided|95.0|-15.4|-5.8|||Hochberg's method||||
1707757|NCT00871234|3141699|Superiority or Other||Median Difference (Net)|0.03||||0.36||95.0|||||Wilcoxon signed-rank||||
1707758|NCT00871143|3141702|Superiority or Other||||||>|0.05||||||Bonferroni corrections were used|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.|
1707759|NCT00871143|3141702|Superiority or Other||||||>|0.05||||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).|
1707760|NCT00871143|3141702|Superiority or Other||||||<|0.05||||||Bonferroni corrections were used to reduce risk of type 1 error|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and 1 month follow up.|
1707761|NCT00871143|3141702|Superiority or Other||||||<|0.05||||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated-measures t tests were then used to determine where significant differences in BIQLI occurred between baseline and end of treatment (12 weeks).|
1707762|NCT00871143|3141702|Superiority or Other||||||<|0.05||||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on BIQLI scores.|
1707763|NCT00871143|3141703|Superiority or Other||||||>|0.05||||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.|
1707764|NCT00871143|3141703|Superiority or Other||||||>|0.05||||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.|
1707844|NCT00869206|3141916|Superiority||Mean Difference (Final Values)|0.7||||0.1|2-Sided|95.0|-0.3|1.7|||Cochran-Mantel-Haenszel||||
1707765|NCT00871143|3141703|Superiority or Other||||||>|0.05||||||Bonferroni corrections were implemented to reduce the risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up assessment.|
1707766|NCT00871143|3141703|Superiority or Other||||||<|0.01||||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 12 week assessment.|
1707767|NCT00871143|3141703|Superiority or Other||||||<|0.05||||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on GAD-7 scores.|
1707768|NCT00871143|3141704|Superiority or Other||||||>|0.05||||||Bonferroni corrections were used to reduce risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.|
1707769|NCT00871143|3141704|Superiority or Other||||||>|0.05||||||A Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).|
1707770|NCT00871143|3141704|Superiority or Other||||||>|0.05||||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to 2 month follow up.|
1707771|NCT00871143|3141704|Superiority or Other||||||<|0.05||||||Where more than 1 t test had been conducted on each variable, a Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences occurred from baseline to end of treatment (12 weeks).|
1707772|NCT00871143|3141704|Superiority or Other||||||>|0.05||||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the PHQ-9 score.|
1707773|NCT00871143|3141705|Superiority or Other||||||>|0.05||||||Bonferroni corrections were used to adjust for type 1 error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.|
1707774|NCT00871143|3141705|Superiority or Other||||||<|0.05||||||Bonferroni Correction was used in an attempt to reduce risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .|
1707775|NCT00871143|3141705|Superiority or Other||||||<|0.001||||||Bonferroni corrections were used to reduce risk of type 1 error|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 2 month follow up.|
1707776|NCT00871143|3141705|Superiority or Other||||||<|0.001||||||Bonferroni corrections were applied to decrease the risk of type I error.|t-test, 2 sided|||Repeated- measures t tests were used to determine where significant differences in AAI scores occurred from baseline to 12 week .|
1707777|NCT00871143|3141705|Superiority or Other||||||<|0.05||||||An alpha level of .05 (two-sided) was set.|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable of AAI scores.|
1707778|NCT00871143|3141706|Superiority or Other||||||>|0.05||||||Bonferroni corrections used to decrease risk of type I error|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and 1 month follow up.|
1707779|NCT00871143|3141706|Superiority or Other||||||>|0.05||||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and week 12.|
1707780|NCT00871143|3141706|Superiority or Other||||||>|0.05||||||Bonferonni corrections used to reduce risk of type I error|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and 1 month follow up.|
1707781|NCT00871143|3141706|Superiority or Other||||||<|0.01||||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in MADRS score between baseline and week 12.|
1707782|NCT00871143|3141706|Superiority or Other||||||>|0.05||||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||A Linear mixed model was conducted to determine the predictive value of treatment group and/or time on the outcome variable MADRS scores.|
1707783|NCT00871143|3141707|Superiority or Other||||||>|0.05||||||Bonferroni corrections were used to reduce risk of type I error|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 1 month follow up measures.|
1707784|NCT00871143|3141707|Superiority or Other||||||>|0.05||||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 12 week assessment measures and baseline and 1 month follow up measures.|
1707785|NCT00871143|3141707|Superiority or Other||||||<|0.001||||||Bonferroni corrections were implemented to adjust for type I error|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 1 month follow up.|
1707786|NCT00871143|3141707|Superiority or Other||||||<|0.01||||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||T-tests were used to investigate significant differences between baseline and 12 week measures|
1707787|NCT00871143|3141707|Superiority or Other||||||<|0.05||||||An alpha level of .05 was set (two-sided).|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.|
1707788|NCT00871143|3141708|Superiority or Other||||||<|0.05||||||Bonferroni correction was used to decrease risk of type I error|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and 1 month follow up|
1707789|NCT00871143|3141708|Superiority or Other||||||<|0.01||||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and week 12|
1707790|NCT00871143|3141708|Superiority or Other||||||<|0.001||||||Bonferroni corrections were used to reduce risk of Type 1 error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between between baseline and 1 month follow up|
1707791|NCT00871143|3141708|Superiority or Other||||||<|0.001||||||Bonferroni correction was used to decrease the risk of type I error.|t-test, 2 sided|||Investigating the difference in BDD YBOCS score between baseline and week 12|
1707792|NCT00871143|3141708|Superiority or Other||||||<|0.001||||||An alpha level of .05 (two-sided) was set.|Mixed Models Analysis|||Linear mixed models were conducted to determine the predictive value of treatment group and/or time on the outcome variable scores.|
1707793|NCT00871117|3141720|Non-Inferiority|Lower limit of the 95% CI for the GMT ratios of poliovirus type 3 antigens was ≥ 0.67.|Adjusted GMT ratio|0.84|||||2-Sided|95.0|0.71|1.01||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 3 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.|
1707794|NCT00871117|3141720|Non-Inferiority|Lower limit of the 95% CI for the GMT ratios of poliovirus type 2 antigens was ≥ 0.67.|Adjusted GMT ratio|0.83|||||2-Sided|95.0|0.7|0.99||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 2 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.|
1707795|NCT00871117|3141720|Non-Inferiority|Lower limit of the 95% CI for the GMT ratios for poliovirus type 1 antigens was ≥ 0.67.|Adjusted GMT ratio|0.91|||||2-Sided|95.0|0.76|1.1||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of poliovirus type 1 geometric mean titers (GMTs), one month after vaccination with DTaP-IPV vaccine.|
1707796|NCT00871117|3141721|Non-Inferiority|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to PRN, was ≥ -10%.|Difference in booster response rates|1.42|||||2-Sided|95.0|-0.32|4.08||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of pertactin (PRN) booster response one month after vaccination with DTaP-IPV vaccine.|
1707797|NCT00871117|3141721|Non-Inferiority|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to FHA was ≥ -10%.|Difference in booster response rates|-0.91|||||2-Sided|95.0|-3.59|1.39||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of filamentous hemagglutinin (FHA) booster response one month after vaccination with DTaP-IPV vaccine.|
1707798|NCT00871117|3141721|Non-Inferiority|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to PT was ≥ -10%|Difference in booster response rates|-0.76|||||2-Sided|95.0|-5.07|3.51||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of pertussis toxoid (PT) booster response one month after vaccination with DTaP-IPV vaccine.|
1707799|NCT00871117|3141722|Non-Inferiority|Lower limit of the standardized asymptotic 95% CI for the between-group differences in booster response to tetanus was ≥ -10%.|Difference in booster response rates|0.98|||||2-Sided|95.0|-1.99|4.26||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of tetanus (T) booster response one month after vaccination with DTaP-IPV vaccine.|
1707800|NCT00871117|3141722|Non-Inferiority|Lower limit of the standardized asymptotic 95% confidence interval (CI) for the between-group differences in booster response to diphtheria was greater than or equal to (≥)-10%.|Difference in booster response rates|0.01|||||2-Sided|95.0|-2.54|2.58||||||To demonstrate the non-inferiority of DTaP-IPV vaccine co-administered with Varicella and MMR vaccines compared to DTaP-IPV vaccine co-administered with MMR only in terms of diphtheria (D) booster response one month after vaccination with DTaP-IPV vaccine.|
1707801|NCT00871000|3141738|Non-Inferiority|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-T antibody concentrations ≥ 0.1 IU/mL was ≤ 10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals’ Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD’s Tetravac™ vaccine, in terms of seroprotection rates against tetanus, one month after vaccination.|
1707802|NCT00871000|3141738|Non-Inferiority|Criterion for evaluation of Non-inferiority: Upper limit (UL) of the standardised asymptotic 95% confidence interval (CI) on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL was lower than or equal to (≤) 10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals’ Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD’s Tetravac™ vaccine, in terms of seroprotection rates against diphtheria, one month after vaccination.|
1707803|NCT00871000|3141739|Non-Inferiority|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-polio type 3 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-2.61|2.72||||||To demonstrate that GSK Biologicals’ Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD’s Tetravac™ vaccine, in terms of seroprotection rates against polio type 3, one month after vaccination.|
1707804|NCT00871000|3141739|Non-Inferiority|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-polio type 2 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals’ Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD’s Tetravac™ vaccine, in terms of seroprotection rates against polio type 2, one month after vaccination.|
1707805|NCT00871000|3141739|Non-Inferiority|Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-polio type 1 antibody titers ≥ 8 was ≤ 10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-2.61|2.7||||||To demonstrate that GSK Biologicals’ Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD’s Tetravac™ vaccine, in terms of seroprotection rates against poliovirus type 1, one month after vaccination.|
1707806|NCT00870545|3141784|Superiority or Other|||||||0.1||||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 months, and 12 months)|
1707807|NCT00870545|3141785|Superiority or Other|||||||0.04||||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in scores over time (baseline, 6 months, and 12 months)|
1707808|NCT00870545|3141786|Superiority or Other|||||||0.26||||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 months, 12 months)|
1707809|NCT00870545|3141787|Superiority or Other||||||<|0.001||||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Change in scores measured across three time points (baseline, 6 and 12 months)|
1707810|NCT00870545|3141788|Superiority or Other|||||||0.2||||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Analysis was change in score over time (baseline, 6 and 12 months)|
1707811|NCT00870545|3141789|Superiority or Other|||||||0.003||||||P values less than or equal to .05 were considered statistically significant, and those between .05 and .10 were considered to document trends that approached, but did not attain, statistical significance.|Mixed Models Analysis|||Change in scores measured across three time points (baseline, 6 and 12 months)|
1707812|NCT00870467|3141798|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1707813|NCT00870467|3141799|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1707814|NCT00870467|3141800|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1707815|NCT00870467|3141801|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1707816|NCT00870467|3141802|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1707817|NCT00870467|3141803|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1707818|NCT00870363|3141810|Superiority or Other||||||>|0.05|||||||Kruskal-Wallis||||
1707819|NCT00870194|3141815|Superiority or Other|||||||1|||||||Fisher`s Exact Test||||
1707820|NCT00870194|3141816|Superiority or Other|||||||0.247|||||||Fisher`s Exact Test||||
1707821|NCT00870194|3141817|Superiority or Other|||||||0.498|||||||Fisher`s Exact Test||||
1707822|NCT00870194|3141818|Superiority or Other|||||||0.287|||||||Fisher`s Exact Test||||
1707823|NCT00870194|3141819|Superiority or Other|||||||0.888|||||||ANCOVA||||
1707824|NCT00870194|3141820|Superiority or Other|||||||0.622|||||||ANCOVA||||
1707825|NCT00870194|3141821|Superiority or Other|||||||0.269|||||||ANCOVA||||
1707826|NCT00870194|3141822|Superiority or Other|||||||0.055|||||||ANCOVA||||
1707827|NCT00870194|3141823|Superiority or Other|||||||0.207|||||||Mixed Model Repeated Measures||||
1707828|NCT00870194|3141824|Superiority or Other|||||||0.567|||||||Mixed Model Repeated Measures||||
1707829|NCT00870194|3141825|Superiority or Other|||||||0.095|||||||Mixed Model Repeated Measures||||
1707830|NCT00870194|3141826|Superiority or Other|||||||0.266|||||||Mixed Model Repeated Measures||||
1707831|NCT00870194|3141827|Superiority or Other|||||||0.038|||||||ANCOVA||||
1707832|NCT00870194|3141828|Superiority or Other|||||||0.48|||||||Fisher`s Exact Test||||
1707833|NCT00870194|3141829|Superiority or Other|||||||0.027|||||||Fisher`s Exact Test||||
1707834|NCT00870194|3141830|Superiority or Other|||||||0.038|||||||Fisher`s Exact Test||||
1707835|NCT00870194|3141831|Non-Inferiority or Equivalence|Non-inferiority margin of 0.4%|Least Square Mean Difference|0.3|Standard Error of the Mean|0.12||0.012|2-Sided|95.0|0.07|0.53|||Mixed Model Repeated Measures||Standard Error of the Least Square Mean|Power calculation: 80% assuming 200 patients (100 in each arm), no true difference and 1.0% standard deviation.|
1707836|NCT00870194|3141831|Non-Inferiority or Equivalence|Non-Inferiority Margin of 0.4%||||||0.012|||||||Mixed Model Repeated Measures||||
1707837|NCT00869622|3141865|Superiority or Other|||||||0.0229|||||||Fisher Exact||||
1707838|NCT00869557|3141882|Non-Inferiority or Equivalence|"A total sample size of 75 participants randomized in a 2:1 ratio had 26% power to evaluate noninferiority with respect to the response rate of HIV-1 RNA < 50 copies/mL at Week 24 if a response rate of 84% for both treatment groups and a noninferiority margin of 0.12 were assumed.~A total of 71 participants were enrolled in the study (4 fewer than planned)."|Difference in the response rates (%)|2.8|||||2-Sided|95.0|-14.5|20.1|||||The 95% confidence interval was computed using normal approximation stratified by baseline HIV-1 RNA stratum (≤ 100,000 or > 100,000 copies/mL).|The null hypothesis was that the response rate (proportion of participants with HIV-1 RNA < 50 copies/mL at Week 24) in the Stribild group was at least 12% worse than the response rate in Atripla group; the alternative hypothesis was that the response rate in the Stribild group was less than 12% worse than that in the Atripla group.|
1707839|NCT00869401|3141893|Superiority or Other (legacy)||Hazard Ratio (HR)|0.806||||0.183|2-Sided|95.0|0.59|1.11|||Log Rank||||
1707840|NCT00869401|3141895|Superiority or Other (legacy)||Hazard Ratio (HR)|0.79||||0.222|2-Sided|95.0|0.54|1.16||Using Logrank Test|Log Rank||||
1707841|NCT00869349|3141900|Superiority or Other||Mean Difference (Net)|1.8||||0.01|2-Sided|95.0|0.5|3.1||a priori threshold for statistical significance was <0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.|
1707842|NCT00869349|3141901|Superiority or Other||Mean Difference (Net)|-3.2||||0.01|2-Sided|95.0|-5.6|-0.8||a priori threshold for statistical significance was <0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.|
1707843|NCT00869349|3141902|Superiority or Other||Mean Difference (Net)|-0.6||||0.04|2-Sided|95.0|-1.1|0.0||a priori threshold for statistical significance was <0.05.|t-test, 2 sided|||Treatment effects are reported as mean between-group differences from baseline to 21 months using t-tests to determine the differential effect of the intervention versus the education group.|
1707845|NCT00869206|3141918|Superiority or Other||Slope|0.0016|Standard Error of the Mean|0.0034||0.64|2-Sided||||||Mixed Models Analysis|Adjusted for tumor type, baseline creatinine, prior SRE, prior bisphosphonates, age, gender, BSA, race, and baseline performance status|||
1707846|NCT00869206|3141919|Superiority or Other||Slope|-0.00394|Standard Error of the Mean|0.00962||0.68|2-Sided||||||Mixed Models Analysis|Model is adjusted for tumor type, baseline creatinine, prior SREs, prior bisphosphonates, age, gender, race, BSA, and baseline performance status|||
1707847|NCT00869206|3141920|Non-Inferiority or Equivalence|Based on the published data on the effect of a standard of dosing schedule of > zoledronic acid compared to placebo, we choose ∆= 7%, πT= 42%, and πS= 35%. With a total of 1230 eligible patients (615 per arm), the probability of rejecting the null hypothesis using a one-sided test is at most 0.05 (Type I error α) when θ≥ 7% and the probability of rejecting the null hypothesis (the power) is at least 82% when θ≤0|||||<=|0|||||||Cochran-Mantel-Haenszel||||
1707848|NCT00869128|3141929|Superiority or Other|||||||0.04|||||||ANOVA|The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.||ANOVA, The effect of Circadin was checked by means of 2 x 2 mixed design analysis of variance for repeated measurement.|
1707849|NCT00868790|3141946|Superiority or Other||LSM Difference|-3.9||||0.248|2-Sided|90.0|-10.2|2.3|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).|
1707850|NCT00868790|3141946|Superiority or Other||LSM Difference|7.8||||0.002|2-Sided|90.0|3.8|11.7|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).|
1707851|NCT00868790|3141946|Superiority or Other||LSM Difference|4.5||||0.06|2-Sided|90.0|0.6|8.4|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).|
1707852|NCT00868790|3141946|Superiority or Other||LSM Difference|-0.8||||0.742|2-Sided|90.0|-4.6|3.1|||LDA Model|||LDL-C values after log transformation were analyzed using a constrained LDA model that included terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). Percentage change from baseline in LDL-C after 4-week treatment was reported, after back-transformation using the delta method with an alpha-level of 0.10 (2-sided).|
1707853|NCT00868790|3141947|Superiority or Other||LSM Difference|-49.4|||<|0.001|2-Sided|90.0|-66.9|-31.8|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). The LDA-model test was conducted at alpha level=0.10 (two sided).|
1707854|NCT00868790|3141947|Superiority or Other||LSM Difference|-78.1|||<|0.001|2-Sided|90.0|-96.4|-59.8|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). The LDA-model test was conducted at alpha level=0.10 (two sided).|
1707855|NCT00868790|3141947|Superiority or Other||LSM Difference|-20.4|||<|0.063|2-Sided|90.0|-38.4|-2.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). The LDA-model test was conducted at alpha level=0.10 (two sided).|
1707856|NCT00868790|3141947|Superiority or Other||LSM Difference|-14.9|||<|0.174|2-Sided|90.0|-33.0|3.2|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). The LDA-model test was conducted at alpha level=0.10 (two sided).|
1707857|NCT00868790|3141948|Superiority or Other||LSM Difference|-20.0||||0.001|2-Sided|90.0|-30.0|-10.1|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). The LDA-model test was conducted at alpha level=0.10 (two sided).|
1707858|NCT00868790|3141948|Superiority or Other||LSM Difference|-36.0|||<|0.001|2-Sided|90.0|-42.0|-30.0|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). The LDA-model test was conducted at alpha level=0.10 (two sided).|
1707886|NCT00868296|3142012|Superiority or Other|||||||0.807||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in head circumference z-score.|
1707887|NCT00868296|3142012|Superiority or Other|||||||0.901||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in weight z-score.|
1707859|NCT00868790|3141948|Superiority or Other||LSM Difference|-21.8|||<|0.001|2-Sided|90.0|-27.8|-15.8|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). The LDA-model test was conducted at alpha level=0.10 (two sided).|
1707860|NCT00868790|3141948|Superiority or Other||LSM Difference|-11.5|||<|0.002|2-Sided|90.0|-17.5|-5.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). The LDA-model test was conducted at alpha level=0.10 (two sided).|
1707861|NCT00868790|3141949|Superiority or Other||LSM Difference|-34.9|||<|0.001|2-Sided|95.0|-44.8|-25.0|||LDA Model|Between-group difference (metformin-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). The LDA-model test was conducted at alpha level=0.10 (two sided).|
1707862|NCT00868790|3141949|Superiority or Other||LSM Difference|-23.4|||<|0.001|2-Sided|90.0|-34.5|-12.4|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). The LDA-model test was conducted at alpha level=0.10 (two sided).|
1707863|NCT00868790|3141949|Superiority or Other||Least Squares Mean (LSM) Difference|-17.2|||<|0.013|2-Sided|90.0|-28.3|-6.1|||LDA Model|Between-group difference (MK-3577-placebo) of LSM changes from BL to a given time point and 90% confidence intervals were estimated from LDA model.||Analysis based on an LDA model including terms for treatment, period, the interaction of treatment by period, prior antihyperglycemic therapy status (yes/no), and randomization stratum (participation in domiciled visits [yes/no]). The LDA-model test was conducted at alpha level=0.10 (two sided).|
1707864|NCT00868699|3141957|Superiority or Other||Mean Difference (Final Values)|-3.5|Standard Error of the Mean|1.01|<|0.001|||||||ANCOVA||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.||
1707865|NCT00868699|3141957|Superiority or Other||Mean Difference (Final Values)|-3.1|Standard Error of the Mean|1.05|<|0.003|||||||ANCOVA||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.||
1707866|NCT00868699|3141958|Superiority or Other||Mean Difference (Final Values)|-0.57|Standard Error of the Mean|0.143|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.||
1707867|NCT00868699|3141958|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.143|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.||
1707868|NCT00868699|3141959|Superiority or Other||Mean Difference (Final Values)|-4.6|Standard Error of the Mean|1.17|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.||
1707869|NCT00868699|3141959|Superiority or Other||Mean Difference (Final Values)|-4.6|Standard Error of the Mean|1.17|<|0.001|||||||Mixed Models Analysis||A negative difference in least square mean change from baseline between Lurasidone group and placebo indicates a greater improvement in the Lurasidone group over the placebo group.||
1707870|NCT00868530|3141984|Superiority or Other|||||||0.12|||||||t-test, 2 sided||||
1707871|NCT00868452|3141994|Superiority or Other||Mean Difference (Final Values)|-2.6|Standard Error of the Mean|1.01||0.012|||||||ANCOVA||||
1707872|NCT00868452|3141995|Superiority or Other||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|0.15||0.003|||||||Mixed Models Analysis||||
1707873|NCT00868452|3141996|Superiority or Other||Mean Difference (Final Values)|-3.6|Standard Error of the Mean|1.25||0.005|||||||Mixed Models Analysis||||
1707874|NCT00868439|3141997|Superiority or Other||||||=|0|||||||Fisher Exact||||
1707875|NCT00868439|3141998|Superiority or Other||||||=|0|||||||Fisher Exact||||
1707876|NCT00868439|3141999|Superiority or Other|||||||0.022|||||||Fisher Exact||||
1707877|NCT00868439|3142000|Superiority or Other||||||=|0|||||||Fisher Exact||||
1707878|NCT00868439|3142001|Superiority or Other||||||=|0|||||||Fisher Exact||||
1707879|NCT00868439|3142002|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1707880|NCT00868296|3142012|Superiority or Other|||||||0.006|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for head circumference z-score.|
1707881|NCT00868296|3142012|Superiority or Other|||||||0.892|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for head circumference z-score.|
1707882|NCT00868296|3142012|Superiority or Other|||||||0.04|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for weight z-score.|
1707883|NCT00868296|3142012|Superiority or Other|||||||0.347|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for weight z-score.|
1707884|NCT00868296|3142012|Superiority or Other|||||||0.016|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for length z-score.|
1707885|NCT00868296|3142012|Superiority or Other|||||||0.595|||||||t-test, 2 sided|paired||Final evaluation compared to baseline within group comparison for length z-score.|
1707936|NCT00867165|3142155|Superiority or Other||Difference in least-squares means|-27.71|||<|0.001|2-Sided|95.0|-31.7|-23.73|||ANCOVA||||
1707888|NCT00868296|3142012|Superiority or Other|||||||0.857||||||Analysis with treatment as factor; baseline as covariate|ANCOVA|||Between group comparison for change from baseline in length z-score.|
1707889|NCT00868166|3142043|Superiority|||||||0.56|||||||Stratified Log-Rank Test||||
1707890|NCT00868166|3142045|Superiority|||||||0.2|||||||Non-stratified Log-Rank Test||||
1707891|NCT00868166|3142045|Superiority|||||||0.21|||||||Stratified Log-Rank Test||||
1707892|NCT00868166|3142047|Superiority|||||||0.73|||||||Non-stratified Log-Rank Test||||
1707893|NCT00868166|3142047|Superiority|||||||0.83|||||||Stratified Log-Rank Test||||
1707894|NCT00868166|3142048|Superiority|||||||0.71|||||||Stratified Log-Rank Test||||
1707895|NCT00867451|3142102|Superiority or Other||||||<|0.05|||||||t-test, 1 sided||||
1707896|NCT00867165|3142115|Superiority or Other||Difference in least-squares means|24.05|||<|0.001|2-Sided|95.0|10.43|37.67|||ANCOVA||||
1707897|NCT00867165|3142116|Superiority or Other||Difference in least-squares means|36.7|||<|0.001|2-Sided|95.0|24.12|49.28|||ANCOVA||||
1707898|NCT00867165|3142117|Superiority or Other||Difference in least-squares means|26.29|||<|0.001|2-Sided|95.0|13.99|38.58|||ANCOVA||||
1707899|NCT00867165|3142118|Superiority or Other||Difference in least-squares means|20.01||||0.001|2-Sided|95.0|8.1|31.91|||ANCOVA||||
1707900|NCT00867165|3142119|Superiority or Other||Difference in least-squares means|-32.14|||<|0.001|2-Sided|95.0|-40.38|-23.9|||ANCOVA||||
1707901|NCT00867165|3142120|Superiority or Other||Difference in least-squares means|-28.74|||<|0.001|2-Sided|95.0|-34.89|-22.59|||ANCOVA||||
1707902|NCT00867165|3142121|Superiority or Other||Difference in least-squares means|-25.61|||<|0.001|2-Sided|95.0|-31.2|-20.02|||ANCOVA||||
1707903|NCT00867165|3142122|Superiority or Other||Difference in least-squares means|-18.35|||<|0.001|2-Sided|95.0|-24.7|-11.99|||ANCOVA||||
1707904|NCT00867165|3142123|Superiority or Other||Difference in least-squares means|-64.67|||<|0.001|2-Sided|95.0|-74.11|-55.23|||ANCOVA||||
1707905|NCT00867165|3142124|Superiority or Other||Difference in least-squares means|-62.6|||<|0.001|2-Sided|95.0|-68.54|-56.66|||ANCOVA||||
1707906|NCT00867165|3142125|Superiority or Other||Difference in least-squares means|-57.99|||<|0.001|2-Sided|95.0|-62.87|-53.11|||ANCOVA||||
1707907|NCT00867165|3142126|Superiority or Other||Difference in least-squares means|-49.48|||<|0.001|2-Sided|95.0|-54.83|-44.14|||ANCOVA||||
1707908|NCT00867165|3142127|Superiority or Other||Difference in least-squares means|-62.74||||0.001|2-Sided|95.0|-73.22|-52.26|||ANCOVA||||
1707909|NCT00867165|3142128|Superiority or Other||Difference in least-squares means|-61.02|||<|0.001|2-Sided|95.0|-67.51|-54.53|||ANCOVA||||
1707910|NCT00867165|3142129|Superiority or Other||Difference in least-squares means|-58.52|||<|0.001|2-Sided|95.0|-63.67|-53.38|||ANCOVA||||
1707911|NCT00867165|3142130|Superiority or Other||Difference in least-squares means|-49.61|||<|0.001|2-Sided|95.0|-55.36|-43.87|||ANCOVA||||
1707912|NCT00867165|3142131|Superiority or Other||Difference in least-squares means|17.27||||0.382|2-Sided|95.0|-20.46|55.0|||Constrained longitudinal data analysis||||
1707913|NCT00867165|3142132|Superiority or Other||Difference in least-squares means|-46.11||||0.116|2-Sided|95.0|-108.14|15.92|||Constrained longitudinal data analysis||||
1707914|NCT00867165|3142133|Superiority or Other||Difference in least-squares means|-19.28|||<|0.001|2-Sided|95.0|-23.87|-14.7|||ANCOVA||||
1707915|NCT00867165|3142134|Superiority or Other||Difference in least-squares means|-28.35|||<|0.001|2-Sided|95.0|-34.41|-22.29|||ANCOVA||||
1707916|NCT00867165|3142135|Superiority or Other||Difference in least-squares means|-29.31|||<|0.001|2-Sided|95.0|-35.71|-22.91|||ANCOVA||||
1707917|NCT00867165|3142136|Superiority or Other||Difference in least-squares means|-25.15|||<|0.001|2-Sided|95.0|-30.69|-19.62|||ANCOVA||||
1707918|NCT00867165|3142137|Superiority or Other||Difference in least-squares means|-24.5|||<|0.001|2-Sided|95.0|-29.88|-19.12|||ANCOVA||||
1707919|NCT00867165|3142138|Superiority or Other||Difference in least-squares means|-22.29|||<|0.001|2-Sided|95.0|-27.25|-17.34|||ANCOVA||||
1707920|NCT00867165|3142139|Superiority or Other||Difference in least-squares means|-23.48|||<|0.001|2-Sided|95.0|-29.0|-17.97|||ANCOVA||||
1707921|NCT00867165|3142140|Superiority or Other||Difference in least-squares means|-20.83|||<|0.001|2-Sided|95.0|-25.59|-16.07|||ANCOVA||||
1707922|NCT00867165|3142141|Superiority or Other||Difference in Least-squares mean|-19.76|||<|0.001|2-Sided|95.0|-24.7|-14.82|||ANCOVA||||
1707923|NCT00867165|3142142|Superiority or Other||Difference in least-squares means|-1.91||||0.373|2-Sided|95.0|-6.15|2.32|||ANCOVA||||
1707924|NCT00867165|3142143|Superiority or Other||Difference in least-squares means|-8.61||||0.149|2-Sided|95.0|-20.44|3.23|||Constrained longitudinal data analysis||||
1707925|NCT00867165|3142144|Superiority or Other||Difference in least-squares means|-15.19||||0.005|2-Sided|95.0|-26.05|-4.34|||Constrained longitudinal data analysis||||
1707926|NCT00867165|3142145|Superiority or Other||Difference in least-squares means|-9.73||||0.137|2-Sided|95.0|-22.73|3.27|||Constrained longitudinal data analysis||||
1707927|NCT00867165|3142146|Superiority or Other||Difference in least-squares means|-26.55|||<|0.001|2-Sided|95.0|-30.35|-22.75|||ANCOVA||||
1707928|NCT00867165|3142147|Superiority or Other||Difference in least-squares means|-24.61|||<|0.001|2-Sided|95.0|-28.06|-21.16|||ANCOVA||||
1707929|NCT00867165|3142148|Superiority or Other||Difference in least-squares means|-24.18|||<|0.001|2-Sided|95.0|-27.78|-20.58|||ANCOVA||||
1707930|NCT00867165|3142149|Superiority or Other||Difference in least-squares means|1.92||||0.501|2-Sided|95.0|-3.71|7.56|||ANCOVA||||
1707931|NCT00867165|3142150|Superiority or Other||Difference in least-squares means|0.53||||0.863|2-Sided|95.0|-5.59|6.66|||ANCOVA||||
1707932|NCT00867165|3142151|Superiority or Other||Difference in least-squares means|-0.95||||0.733|2-Sided|95.0|-6.46|4.55|||ANCOVA||||
1707933|NCT00867165|3142152|Superiority or Other||Difference in least-squares means|-21.37|||<|0.001|2-Sided|95.0|-24.67|-18.08|||ANCOVA||||
1707934|NCT00867165|3142153|Superiority or Other||Difference in least-squares means|-20.27|||<|0.001|2-Sided|95.0|-23.39|-17.15|||ANCOVA||||
1707935|NCT00867165|3142154|Superiority or Other||Difference in least-squares means|-20.09|||<|0.001|2-Sided|95.0|-23.3|-16.89|||ANCOVA||||
1707937|NCT00867165|3142156|Superiority or Other||Difference in least-square means|-23.94|||<|0.001|2-Sided|95.0|-27.49|-20.39|||ANCOVA||||
1707938|NCT00867165|3142157|Superiority or Other||Difference in least-squares means|-24.97|||<|0.001|2-Sided|95.0|-28.95|-20.99|||ANCOVA||||
1707939|NCT00867165|3142158|Superiority or Other||Difference in least-square means|-14.68||||0.021|2-Sided|95.0|-27.35|-2.0|||Constrained longitudinal data analysis||||
1707940|NCT00867165|3142159|Superiority or Other||Differrence in least-squares means|-25.75|||<|0.001|2-Sided|95.0|-29.59|-21.91|||ANCOVA||||
1707941|NCT00867165|3142160|Superiority or Other||Difference in least-square means|0.7||||0.807|2-Sided|95.0|-4.97|6.36|||ANCOVA||||
1707942|NCT00867165|3142161|Superiority or Other||Difference in least-squares means|-20.24|||<|0.001|2-Sided|95.0|-24.02|-16.45|||ANCOVA||||
1707943|NCT00867165|3142162|Superiority or Other||Difference in least-squares means|-20.92|||<|0.001|2-Sided|95.0|-24.2|-17.65|||ANCOVA||||
1707944|NCT00867165|3142163|Superiority or Other||Difference in least-squares means|-26.74|||<|0.001|2-Sided|95.0|-30.8|-22.69|||ANCOVA||||
1707945|NCT00867035|3142194|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Percentage of black colonies out of Total Viable Count cultured on anaerobe agar with lead acetate. Black colonies are those producing sulfides (H2S, MM)and creating black lead sulfide. Analyzed between groups. Groups compared at baseline and 1 week.|
1707946|NCT00867035|3142195|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Counts of colony forming units from swab of 1square centimeter area on tongue at 1 week cultured on anaerobe plates for 1 week analyzed between groups|
1707947|NCT00867035|3142196|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Concentrtations of MM in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test|
1707948|NCT00867035|3142197|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Concentrations of MM in mouth air at 4 hours analyzed between groups. Each time point was compared between groups by Students t test.|
1707949|NCT00867035|3142198|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Concentrations of MM in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test|
1707950|NCT00867035|3142199|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Concentrations of MM in mouth air at 1 hour analyzed between groups|
1707951|NCT00867035|3142200|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Concentrations of H2S in mouth air at 1 week analyzed between groups. Each time point was compared between groups by Students t test.|
1707952|NCT00867035|3142201|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Concentrations of H2S in mouth air at 4 hours analyzed between groups|
1707953|NCT00867035|3142202|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Concentrations of H2S in mouth air at 2 hours analyzed between groups. Each time point was compared between groups by Students t test.|
1707954|NCT00867035|3142203|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Concentrations of H2S in mouth air at 1 hour analyzed between groups.|
1707955|NCT00867035|3142204|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||baseline to 1 week|
1707956|NCT00867035|3142204|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||baseline to 4 hours|
1707957|NCT00867035|3142204|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||baseline to 2 hours|
1707958|NCT00867035|3142204|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||baseline to 1 week|
1707959|NCT00867035|3142204|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||baseline to 4 hours|
1707960|NCT00867035|3142204|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||baseline to 2 hours|
1707961|NCT00867035|3142204|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||mann whitney u to compare rosenberg score baseline to 1 hour|
1707962|NCT00867035|3142204|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Rosenberg scores compared baseline to 1 hour by Mann-Whitney U test.|
1707963|NCT00867009|3142205|Superiority or Other||Percentage of participants with response|59.6|||||2-Sided|80.0|53.06|65.94|||||||
1707964|NCT00867009|3142206|Superiority or Other||Percentage of participants with response|45.0|||||2-Sided|80.0|39.0|51.0|||||||
1707965|NCT00867009|3142207|Superiority or Other||Median number of months|5.82|||||2-Sided|80.0|4.4|6.7|||||||
1707966|NCT00867009|3142208|Superiority or Other||Percentage of participants with response|38.5|||||2-Sided|80.0|32.3|45.09|||||||
1707967|NCT00866788|3142234|Superiority or Other|||||||0.6504||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707968|NCT00866788|3142234|Superiority or Other|||||||0.162||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707969|NCT00866788|3142234|Superiority or Other|||||||0.7261||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707970|NCT00866788|3142235|Superiority or Other|||||||0.0449||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707971|NCT00866788|3142235|Superiority or Other|||||||0.1525||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707972|NCT00866788|3142235|Superiority or Other|||||||0.5507||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707973|NCT00866788|3142236|Superiority or Other|||||||0.0248||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707974|NCT00866788|3142236|Superiority or Other|||||||0.0003||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707975|NCT00866788|3142236|Superiority or Other|||||||0.1411||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707976|NCT00866788|3142237|Superiority or Other|||||||0.0558||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707977|NCT00866788|3142237|Superiority or Other|||||||0.0005||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707978|NCT00866788|3142237|Superiority or Other|||||||0.164||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707979|NCT00866788|3142238|Superiority or Other|||||||0.0473||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707980|NCT00866788|3142238|Superiority or Other|||||||0.0003||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707981|NCT00866788|3142238|Superiority or Other|||||||0.1601||||||The p-value was based on the van Elteren test (stratified by baseline weight ≥ 80 or < 80 kg).|van Elteren test||||
1707982|NCT00866697|3142279|Superiority or Other||Hazard Ratio (HR)|0.766||||0.0021|2-Sided|95.0|0.643|0.911||The P-value from the stratified log-rank test was adjusted for the two stratification factors.|Log Rank||The Hazard Ratio was estimated using a Pike estimator.||
1707983|NCT00866658|3142291|Superiority or Other||Least squares (LS) mean difference|-0.88|Standard Error of the Mean|0.118|<|0.0001|2-Sided|95.0|-1.116|-0.65||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c (<8.0, >=8.0%),sulfonylurea use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 145 patients in each arm would provide a power of 90% assuming common standard deviation of 1.3% with a 2-sided t test at 5% significance level.|
1707984|NCT00866619|3142357|Superiority|Point estimate of efficacy was adjusted for study site as stratification factor for the analysis. Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE > 0.|Vaccine efficacy|31.315|||<|0.0001|2-Sided|97.5|23.556|38.286|||Regression, Cox|||The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus [Hazard Ratio (HR) in GSK257049 [6-12W] Group (HR1) divided by HR in control Menjugate Comparator [6-12W] Group (HR2)]; i. e. 1 - (HR1/HR2).|
1707985|NCT00866619|3142358|Superiority|Criterion for success = lower limit (LL) of 97.5% confidence interval (CI) of VE > 0.|Vaccine efficacy|55.8|||<|0.0001|2-Sided|97.5|50.6|60.4|||Regression, Cox|||The analysis aimed to compare RfoCPFMI between groups over the Months 2.5-14 time period. Using RfoCFPMI, a Cox regression model was used to evaluate vaccine efficacy (VE) allowing for adjustment by factors. VE was calculated as 1 minus [Hazard Ratio (HR) in GSK257049 [5-17M] Group (HR1) divided by HR in control VeroRab Comparator [5-17M] Group (HR2)]; i. e. 1 - (HR1/HR2).|
1707986|NCT00866359|3142382|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.1||||0.0007|2-Sided|95.0|-1.7|-0.5|||ANCOVA||Based on an Ancova model for change from baseline with treatment group, gender and interaction of treatment group and gender as factors and the baseline value as a covariate.||
1707987|NCT00866359|3142383|Superiority or Other (legacy)||adjusted difference (percentage)|39.1|||<|0.0001|2-Sided|95.0|23.6|54.5|||Cochran-Mantel-Haenszel|Two-sided p-value was based on the CMH test adjusting for gender.|Adjusted difference in proportions = weighted average of treatment differences across gender with the CMH weights.||
1707988|NCT00866359|3142384|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.7||||0.0007|2-Sided|95.0|-2.7|-0.8|||ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.||
1707989|NCT00866359|3142387|Superiority or Other (legacy)||Mean Difference (Final Values)|-90.07|||<|0.0001|2-Sided|95.0|-125.32|-54.82||The last post-baseline observation was carried forward to Day 85 for participants who discontinued the study before Day 85. For participants who did not have Day 85 visit on the targeted date, the total AUC was adjusted by the actual study days.|ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.||
1707990|NCT00866359|3142390|Superiority or Other (legacy)||Least Squares mean difference|-26.8|||<|0.0001|2-Sided|95.0|-35.5|-18.0|||ANCOVA||Based on an analysis of covariance model for the oral ulcer pain VAS at Day 85, with treatment group and gender as factors and the baseline oral ulcer pain VAS as a covariate.||
1707991|NCT00866359|3142391|Superiority or Other (legacy)||Least Squares Mean Difference|-1.6|||<|0.0001|2-Sided|95.0|-2.4|-0.9|||ANCOVA||Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group and gender as factors and the baseline ulcer number as a covariate.||
1707992|NCT00866307|3142400|Superiority or Other (legacy)||Percentage|53.3|||||2-Sided|90.0|38.7|67.4||||||Per protocol, percentage receiving at least 8 doses is compared to a null fixed rate (<=42%). A 90% two-sided Agresti-Coull confidence interval will be constructed. Will reject null if lower bound of confidence interval is above 42%.|
1707993|NCT00866307|3142401|Superiority or Other (legacy)||Percentage|50.0|||||2-Sided|90.0|35.6|64.4||||||Per protocol, percentage of high risk-High patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy is compared to a null fixed rate (<=73%). A 90% two-sided Agresti-Coull confidence interval will be constructed and the lower bound examined. Will reject null if lower bound of confidence interval is above 73%.|
1707994|NCT00866294|3142407|Superiority or Other||Mean Difference (Net)|-2.4|||<|0.001|2-Sided|95.0|-3.8|-1.1||The hypothesis test was conducted with a two-sided significance level of 5% to show the superiority of paroxetine CR relative to placebo.|ANCOVA|The primary analysis was based on an ANCOVA with a model adjusting for baseline HAM-D total score and region (Japan and South Korea).|Mean difference = paroxetine CR minus placebo||
1707995|NCT00865709|3142442|Superiority or Other|||||||0.023||||||1-sided p-value from the Cochran-Mantel-Haenszel test, adjusting for the stratification factors of # metastatic sites and liver metastasis determined by Principal Investigator|Cochran-Mantel-Haenszel|||The proportion of subjects achieving overall response (CR or PR), when confirmation of response was not required, was estimated with a 95% confidence interval for each treatment group. The treatment groups were compared with respect to overall response rate using the Cochran-Mantel-Haenszel test, adjusting for the stratification factors.|
1708041|NCT00863798|3142610|Superiority or Other||Odds Ratio (OR)|1.123||||0.551|2-Sided|95.0|0.77|1.65|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.|
1709146|NCT00852995|3144527|Superiority or Other|||||||0.6786||||||Visit 13|Cochran-Mantel-Haenszel||||
1707996|NCT00865709|3142443|Superiority or Other||Hazard Ratio (HR)|0.829||||0.1437|2-Sided|95.0|0.586|1.174||1-sided p-value from stratified log-rank test, stratified by factors of # metastatic sites and liver metastasis determined by Principal Investigator|Log Rank||The relative risk (sorafenib to placebo) was estimated by the hazard ratio from stratified Cox regression with a 95% confidence interval.|A sample size of 120 PDs would provide a > 85% power at a target HR = 0.65 between sorafenib and matching placebo, with a 1-sided alpha = 0.10, for testing H0: HR ≥ 1 versus H1: HR < 1 based on the log-rank test. The test was conducted using the intent-to-treat (ITT) population (all subjects who were randomized).|
1707997|NCT00865709|3142445|Superiority or Other||Hazard Ratio (HR)|0.884||||0.2309|2-Sided|95.0|0.635|1.231||1-sided p-value from stratified log-rank test, stratified by factors of # metastatic sites and liver metastasis determined by Principal Investigator|Log Rank||The relative risk (sorafenib to placebo) was estimated by the hazard ratio from stratified Cox regression with a 95% confidence interval.|A sample size of 120 PFS events would provide a > 85% power at a target HR = 0.65 between sorafenib and matching placebo, with a 1-sided alpha = 0.10, for testing the null hypothesis H0: HR ≥ 1 versus the alternative hypothesis H1: HR < 1 based on the log-rank test. The test was conducted using the intent-to-treat (ITT) population, defined as all subjects who were randomized to treatment.|
1707998|NCT00865566|3142449|Other||Hazard Ratio (HR)|1.06||||0.783|2-Sided|95.0|0.71|1.58||Adjusted for ave, behavioral risk score, square of behavioral risk score, and BMI|Regression, Cox|Score test|HR is vaccine / placebo||
1707999|NCT00865566|3142450|Other||Hazard Ratio (HR)|1.02||||0.903|2-Sided|95.0|0.73|1.42||Score test|Regression, Cox|Adjusted for age, behavioral risk score, square of behavioral risk score, race, and BMI|HR is vaccine / placebo||
1708000|NCT00865566|3142451|Other||Cox Proportional Hazard|0.71|||<|0.001|2-Sided|95.0|0.6|0.84||Score test|Regression, Cox||HR is vaccine / placebo|Assess the association between treatment assignment and dropout|
1708001|NCT00865566|3142452|Other||Hazard Ratio (HR)|0.77||||0.05|2-Sided|95.0|0.59|1.0||Score test|Regression, Cox||HR is vaccine / placebo|Cox PH model to assess the association between treatment assignment and dropout|
1708002|NCT00865566|3142453|Other|Score test|Hazard Ratio (HR)|0.73|||<|0.001|2-Sided|95.0|0.63|0.84|||Regression, Cox||HR is vaccine / placebo|Cox proportional hazards model to assess the association between treatment assignment and dropout|
1708003|NCT00865345|3142457|Superiority or Other||Intercept from ANCOVA model|70.0|Standard Error of the Mean|2.0|<|0.05|2-Sided|95.0|60.0|100.0|||ANCOVA|null model ANOVA is used to calculate 95% CI around accuracy rate. Intercept was fit in the abscence of other predictors.|||
1708004|NCT00865306|3142459|Superiority or Other||||||<|0.01|||||||Chi-squared||||
1708005|NCT00865306|3142460|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1708006|NCT00865189|3142476|Superiority or Other|||||||0.906|||||||Binomial test|||This proportion was described for each treatment arm with a 95% CI and compared with the standard proportion of 10% (CI) using for each treatment arm.|
1708007|NCT00865189|3142476|Superiority or Other|||||||0.015|||||||Binomial test|||This proportion was described for each treatment arm with a 95% confidence interval (CI) and compared with the standard proportion of 10% (CI) for each treatment arm.|
1708008|NCT00864916|3142493|Superiority or Other||Mean Difference (Final Values)|-1.34||||0.52|||||||Regression, Linear||||
1708009|NCT00864682|3142515|Superiority or Other||||||<|0.008|||||||Chi-squared|Fisher's exact test after chi-squared|||
1708010|NCT00864682|3142516|Superiority or Other||||||<|0.0001|||||||Kruskal-Wallis|||Hypothesis: Lidocaine / propofol admixture would be superior to lidocaine pretreatment for attenuating propofol-induced injection pain. Sample size calculated to detect a difference of at least 2 VPS points; beta 0.8.|
1708011|NCT00864383|3142565|Non-Inferiority or Equivalence|Noninferiority was defined as a between-group difference of less than 6 percentage points in the upper boundary of the two-sided 97.5% Wald confidence interval for the proportion of patients with an unfavorable outcome.|Adjusted difference from control|11.4|||||2-Sided|97.5|6.7|16.1|||||Adjusted difference from control in rate of unfavorable outcome- percentage points||
1708012|NCT00864383|3142565|Non-Inferiority or Equivalence|Noninferiority was defined as a between-group difference of less than 6 percentage points in the upper boundary of the two-sided 97.5% Wald confidence interval for the difference in proportion of patients with an unfavorable outcome.|Adjusted difference in proportions|6.1|||||2-Sided|97.5|1.7|10.5|||||Adjusted difference from control in proportion of unfavorable outcome - percentage points||
1708013|NCT00864253|3142573|Superiority or Other (legacy)||Hazard Ratio (HR)|2.201||||0.057|2-Sided|95.0|0.959|5.053|||Log Rank||||
1708014|NCT00864253|3142574|Superiority or Other (legacy)||Response Rate Ratio|1.442||||0.004|2-Sided|95.0|1.123|1.582|||Chi-squared||||
1708015|NCT00864253|3142575|Superiority or Other (legacy)||Response Rate Ratio|1.305||||0.239|2-Sided|95.0|0.837|2.035|||Chi-squared||||
1708016|NCT00864253|3142576|Superiority or Other (legacy)||Hazard Ratio (HR)|0.845||||0.086|2-Sided|95.0|0.696|1.025|||Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.|||
1708017|NCT00864253|3142577|Superiority or Other (legacy)||Hazard Ratio (HR)|0.831||||0.094|2-Sided|99.9|0.578|1.196||At the time of the final PFS analysis, an interim analysis of survival was reported. The spending function allocated an alpha of 0.001 and 0.049 for the interim and final analysis, respectively, to preserve the overall Type I error at 0.050.|Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||For the participant survival, at the time at least 417 events are recorded, this sample size provides at least 80% power with a two-sided Type 1 error of 0.049 to reject the null hypothesis that the ABI-007/dacarbazine hazard ratio is equal to 1.0. This was based on a HR = 0.760. Proportional hazards were assumed.|
1708042|NCT00863798|3142610|Superiority or Other||Odds Ratio (OR)|1.182||||0.3893|2-Sided|95.0|0.81|1.73|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.|
1708043|NCT00863798|3142611|Superiority or Other||Odds Ratio (OR)|0.894||||0.6509|2-Sided|95.0|0.55|1.45|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.|
1708228|NCT00861757|3142847|Superiority or Other|||||||0.274||||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)||||
1708018|NCT00864253|3142578|Superiority or Other (legacy)||Hazard Ratio (HR)|0.792||||0.044|2-Sided|95.1|0.631|0.992||An interim safety review was performed by DMC. An alpha spending function was utilized to preserve the overall Type 1 error at 0.050. The spending function allocated alpha of 0.001 and 0.049 to the interim and final analyses of PFS, respectively.|Log Rank|The treatment difference was tested using the stratified log-rank test, stratified by metastatic stage, region, and baseline LDH.||Two hundred fifty-seven (257) patients were to be randomized to each treatment group for a total of 514 patients. This sample size was chosen to provide at least 80% power for the final analysis (with a two-sided type I error of 0.049) to reject the null hypothesis that the ABI 007/dacarbazine hazard ratio (HR) for PFS is equal to 1.0. This sample size calculation was based on estimates of HR = 0.750. Proportional hazards were assumed.|
1708019|NCT00864123|3142592|Superiority or Other||Mean Difference (Final Values)|3.0|Standard Deviation|1.1|<|0.05|2-Sided|95.0|||||ANOVA|||Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CGI-Severity) fixed-effects linear regression with time as the repeated measure. Cohen’s d was used to examine the magnitude of treatment effects.|
1708020|NCT00864123|3142593|Superiority or Other||Mean Difference (Final Values)|11.0|Standard Deviation|6.3|<|0.05||95.0|||||ANOVA|||Data were analyzed with separate 2 (site: Florida, MGH) by 2 (condition: CBT+DCS, CBT+Placebo) by 3 (time: pre-treatment, mid-treatment, post-treatment; Dependent variables: CY-BOCS Total Score) fixed-effects linear regression with time as the repeated measure. Cohen’s d was used to examine the magnitude of treatment effects.|
1708021|NCT00863798|3142603|Superiority or Other|||||||0.805|||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.|
1708022|NCT00863798|3142603|Superiority or Other|||||||0.154|||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.|
1708023|NCT00863798|3142603|Superiority or Other|||||||0.805|||||||Regression, Logistic|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.|
1708024|NCT00863798|3142603|Superiority or Other|||||||0.978|||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 10.|
1708025|NCT00863798|3142603|Superiority or Other|||||||0.805|||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 9.|
1708026|NCT00863798|3142603|Superiority or Other|||||||0.805|||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate was used at Week 8.|
1708027|NCT00863798|3142605|Superiority or Other||Odds Ratio (OR)|1.272||||0.2794|2-Sided|95.0|0.82|1.97|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.|
1708028|NCT00863798|3142605|Superiority or Other||Odds Ratio (OR)|0.8||||0.3097|2-Sided|95.0|0.52|1.23|||Regression, Linear|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.|
1708029|NCT00863798|3142606|Superiority or Other||Mean Difference (Final Values)|-0.77||||0.129|2-Sided|95.0|-1.75|0.22|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1708030|NCT00863798|3142606|Superiority or Other||Mean Difference (Final Values)|-1.54||||0.002|2-Sided|95.0|-2.53|-0.56|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1708031|NCT00863798|3142607|Superiority or Other||Mean Difference (Final Values)|0.22||||0.355|2-Sided|95.0|-0.24|0.68|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score."|
1708032|NCT00863798|3142607|Superiority or Other||Mean Difference (Final Values)|0.45||||0.056|2-Sided|95.0|-0.01|0.91|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score."|
1708033|NCT00863798|3142607|Superiority or Other||Mean Difference (Final Values)|0.27||||0.277|2-Sided|95.0|-0.22|0.76|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life and leisure activities component score."|
1708034|NCT00863798|3142607|Superiority or Other||Mean Difference (Final Values)|0.5||||0.045|2-Sided|95.0|0.01|0.98|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life and leisure activities component score."|
1708035|NCT00863798|3142607|Superiority or Other||Mean Difference (Final Values)|0.53||||0.027|2-Sided|95.0|0.06|1.0|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score."|
1708036|NCT00863798|3142607|Superiority or Other||Mean Difference (Final Values)|0.48||||0.043|2-Sided|95.0|0.02|0.95|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score."|
1708037|NCT00863798|3142607|Superiority or Other||Mean Difference (Final Values)|1.15||||0.096|2-Sided|95.0|-0.2|2.49|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score."|
1708038|NCT00863798|3142607|Superiority or Other||Mean Difference (Final Values)|1.46||||0.033|2-Sided|95.0|0.12|2.79|||ANCOVA|||"Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score."|
1708039|NCT00863798|3142609|Superiority or Other||Odds Ratio (OR)|1.085||||0.6679|2-Sided|95.0|0.75|1.57|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor.|
1708040|NCT00863798|3142609|Superiority or Other||Odds Ratio (OR)|1.442||||0.0536|2-Sided|95.0|0.99|2.09|||Regression, Logistic|||Analysis would be conducted with a logistic regression model with treatment as a factor.|
1708044|NCT00863798|3142611|Superiority or Other||Odds Ratio (OR)|1.236||||0.3667|2-Sided|95.0|0.78|1.96|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.|
1708045|NCT00863798|3142612|Superiority or Other||Odds Ratio (OR)|1.102||||0.6169|2-Sided|95.0|0.75|1.61|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.|
1708046|NCT00863798|3142612|Superiority or Other||Odds Ratio (OR)|1.254||||0.2415|2-Sided|95.0|0.86|1.83|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.|
1708047|NCT00863798|3142613|Superiority or Other||Mean Difference (Final Values)|0.44||||0.253|2-Sided|95.0|-0.32|1.2|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1708048|NCT00863798|3142613|Superiority or Other||Mean Difference (Final Values)|0.74||||0.054|2-Sided|95.0|-0.01|1.5|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1708049|NCT00863798|3142614|Superiority or Other||Mean Difference (Final Values)|0.89||||0.316|2-Sided|95.0|-0.85|2.64|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1708050|NCT00863798|3142614|Superiority or Other||Median Difference (Final Values)|1.41||||0.114|2-Sided|95.0|-0.34|3.16|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1708051|NCT00863798|3142615|Superiority or Other||Mean Difference (Final Values)|0.03||||0.757|2-Sided|95.0|-0.16|0.23|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1708052|NCT00863798|3142615|Superiority or Other||Mean Difference (Final Values)|0.15||||0.13|2-Sided|95.0|-0.04|0.35|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1708053|NCT00863798|3142616|Superiority or Other|||||||0.204||||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of `Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.|
1708054|NCT00863798|3142616|Superiority or Other|||||||0.076||||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of `Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.|
1708055|NCT00863798|3142617|Superiority or Other||Mean Difference (Final Values)|0.51||||0.421|2-Sided|95.0|-0.73|1.75||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.|
1708056|NCT00863798|3142617|Superiority or Other||Mean Difference (Final Values)|0.86||||0.175|2-Sided|95.0|-0.38|2.1||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare DVS SR 10 mg to placebo. The comparison was performed at the 0.05 level overall.|
1708057|NCT00863746|3142618|Superiority or Other|||||||0.9228||||||p-value for treatment effect equal to 0.|Mixed Models Analysis||||
1708058|NCT00863746|3142619|Superiority or Other|||||||0.1438||||||p-value for test of treatment effect equal to 0.|Mixed Models Analysis||||
1708059|NCT00863746|3142620|Superiority or Other|||||||0.8344||||||p-value for test of treatment effect equal to 0|Mixed Models Analysis||||
1708060|NCT00863746|3142621|Superiority or Other|||||||0.2948||||||p-value for test of treatment effect equal to 0|Mixed Models Analysis||||
1708061|NCT00863746|3142622|Superiority or Other|||||||0.3121||||||p-value for test of treatment effect equal to 0.|Mixed Models Analysis||||
1708062|NCT00863746|3142623|Superiority or Other||Hazard Ratio (HR)|0.542|||<|0.0001|2-Sided|95.0|0.4526|0.6492||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo|
1708063|NCT00863746|3142624|Superiority or Other||CMH-adjusted difference in proportions|0.039||||0.000876|2-Sided|95.0|0.0137|0.0642|||Cochran-Mantel-Haenszel|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment|||
1708064|NCT00863746|3142625|Superiority or Other||CMH-adjusted difference in proportions|0.2263|||<|1e-06|2-Sided|95.0|0.1575|0.2952|||Cochran-Mantel-Haenszel|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment|||
1708065|NCT00863746|3142626|Superiority or Other||Hazard Ratio (HR)|0.6068|||<|0.0001|2-Sided|95.0|0.5139|0.7165||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo|
1708066|NCT00863746|3142627|Superiority or Other||Hazard Ratio (HR)|0.9934||||0.4687|2-Sided|95.0|0.8409|1.1735||p-value of one-sided test (significance level 2.5%)|Log Rank|stratified by region, number of prior treatments, presence brain mets at baseline, prior EGFR inhibitor treatment||Test for superiority of Sorafenib over Placebo|
1708067|NCT00863655|3142640|Superiority or Other||Hazard Ratio (HR)|0.43|||<|0.0001|2-Sided|95.0|0.35|0.54|||Log Rank||||
1708068|NCT00863343|3142653|Superiority or Other||Specificity|0.997|||||2-Sided|95.0|0.98|1.0|||||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.||
1708069|NCT00863343|3142653|Superiority or Other||Sensitivity|0.79|||||2-Sided|95.0|0.6|0.9|||||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.||
1708070|NCT00863343|3142654|Superiority or Other||Specificity|0.997||||||95.0|0.98|1.0|||||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.||
1708071|NCT00863343|3142654|Superiority or Other||Sensitivity|0.88|||||2-Sided|95.0|0.7|0.96|||||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.||
1708072|NCT00863343|3142655|Superiority or Other||Specificity|0.997|||||2-Sided|95.0|0.98|1.0|||||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.||
1708073|NCT00863343|3142655|Superiority or Other||Sensitivity|0.81|||||2-Sided|95.0|0.63|0.92|||||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.||
1708074|NCT00863343|3142656|Superiority or Other||Specificity|0.987|||||2-Sided|95.0|0.97|0.99|||||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.||
1708075|NCT00863343|3142656|Superiority or Other||Sensitivity|0.82|||||2-Sided|95.0|0.59|0.94|||||Parameter dispersion type is not applicable. Sensitivity is the proportion of the actual positives that are correctly identified as such by the MSD test.||
1708076|NCT00863265|3142659|Equivalence||Mean Difference (Final Values)|7.0|||<|0.05|2-Sided|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal.|
1708077|NCT00863265|3142659|Equivalence||Mean Difference (Final Values)|28.0|||<|0.01|2-Sided|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that all groups are equal|
1708078|NCT00863265|3142659|Equivalence||Mean Difference (Final Values)|21.0|||<|0.01|2-Sided||||||ANOVA|||The hypothesis is that groups are equal.|
1708079|NCT00863265|3142660|Equivalence||Mean Difference (Final Values)|13.6|||<|0.01|2-Sided|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal.|
1708080|NCT00863265|3142660|Equivalence||Mean Difference (Final Values)|36.4|||<|0.01|2-Sided|||||Adjusted for multiple comparisons.|ANOVA|||Placebo vs. Ezetimibe Plus Phytosterols|
1708081|NCT00863265|3142660|Equivalence|Not applicable in this study.|Mean Difference (Final Values)|22.8|||<|0.01|2-Sided|||||Adjusted for multiple comparisons.|ANOVA|||The hypothesis is that groups are equal|
1708082|NCT00863265|3142661|Equivalence|The hypothesis is that groups are equal|Mean Difference (Final Values)|168.0|||<|0.01|2-Sided||||||ANOVA|||Ezetimibe vs. Ezetimibe Plus Phytosterols|
1708083|NCT00863265|3142661|Equivalence|The hypothesis is that groups are equal.|Mean Difference (Final Values)|457.0|||<|0.01|2-Sided||||||ANOVA|||Placebo vs. Ezetimibe Plus Phytosterols|
1708084|NCT00863265|3142661|Equivalence||Mean Difference (Final Values)|289.0|||<|0.01|2-Sided||||||ANOVA||The estimation parameter is the difference between the placebo group and the ezetimibe group.|Phytosterol Diet compared to Ezetimibe|
1708085|NCT00863109|3142671|Superiority or Other|||||||0.022|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in CLDQ-HCV Global domain|
1708086|NCT00863109|3142671|Superiority or Other|||||||0.009|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in Worry domain|
1708087|NCT00863109|3142671|Superiority or Other|||||||0.014|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in Emotional Function domain|
1708088|NCT00863109|3142672|Superiority or Other|||||||0.038|||||||Student´s t-test for paired samples|||Between-group comparison of change from baseline in MCS|
1708089|NCT00863109|3142673|Superiority or Other|||||||0.027|||||||Student´s t-test for paired samples|||Within-group comparison of Worry domain between BL Visit and WK72 Visit|
1708090|NCT00862979|3142688|Superiority|||||||0.008|||||||Wilcoxon (Mann-Whitney)||||
1708091|NCT00862979|3142690|Superiority||Mean Difference (Final Values)|-11.3|||<|0.0001|2-Sided|95.0|-16.5|-6.1|||ANCOVA|||Month 18|
1708092|NCT00862979|3142690|Superiority||Mean Difference (Final Values)|-14.0|||<|0.0001|2-Sided|95.0|-19.6|-8.3|||ANCOVA|||Month 12|
1708093|NCT00862979|3142692|Other|difference||||||0.002|||||||Fisher Exact|||Month 9 to Month 18|
1708094|NCT00862979|3142692|Other|difference||||||0.203|||||||Fisher Exact|||Month 6 to Month 9|
1708095|NCT00862979|3142693|Superiority||Mean Difference (Net)|-11.3|||<|0.0001|2-Sided|95.0|-16.5|-6.1|||ANCOVA||||
1708096|NCT00862940|3142694|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.46||0.602|2-Sided|95.0|-0.67|1.15||The p-value represents the difference from placebo for MMSE at Week 52 (MMRM).|MMRM||||
1708097|NCT00862940|3142695|Superiority or Other||Mean Difference (Final Values)|1.68|Standard Error of the Mean|0.79||0.034|2-Sided|95.0|0.13|3.23||The p-value represents the difference from placebo for COWAT at Week 52 (MMRM).|MMRM||||
1708098|NCT00862940|3142696|Superiority or Other||Adjusted mean difference|-3.5|Standard Error of the Mean|17.52||0.842|2-Sided|95.0|-38.04|31.04|||MMRM|||Mixed model repeated measurements (MMRM) with unstructured covariance including time, time-by-treatment, visit, pre-treatment HCV, and AChEI group.|
1708099|NCT00862940|3142697|Superiority or Other||Adjusted mean difference|-0.04|Standard Error of the Mean|1.3||0.9754|2-Sided|95.0|-2.6|2.52|||Mixed Models Analysis|||Linear mixed model relating direct change in brain volume (BBSI) to time and its interaction with treatment group. This model additionally includes a time-by-AChEI group interaction as a fixed effect.|
1708100|NCT00862849|3142703|Superiority or Other||LS Mean Difference|16.7||||0.0015|2-Sided|90.0|8.45|24.94||Treatment comparison for %AUC(0-30). Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed|||
1708179|NCT00862459|3142799|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Deviation|1.42||||95.0|-1.17|-0.42|||||||
1708180|NCT00862459|3142800|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Deviation|3.18||||95.0|-0.9|0.79|||||||
1709147|NCT00852995|3144527|Superiority or Other|||||||0.1144||||||Visit 13|Cochran-Mantel-Haenszel||||
1708101|NCT00862849|3142703|Superiority or Other||LS Mean Difference|26.47|||<|0.0001|2-Sided|90.0|18.22|34.71||Treatment comparison for %AUC(0-30). Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|Mixed Models Analysis|Analysis performed using mixed model with fixed effect for treatment. A compound symmetry covariance matrix among repeated measurements was assumed.|||
1708102|NCT00862823|3142713|Non-Inferiority or Equivalence|The sample size was determined so there was an 80% chance that a 90% pairwise interval for 2 equivalent formulations would satifsy the FDA criteria for AUC and Cmax of log (0.8), log (1.2).|Geometric Mean Ratio|0.97|||<|0.05||90.0||||Bioequivalent measurew were log-transformed|log transformation||||
1708103|NCT00862745|3142732|Superiority or Other||||||<|0.001||||||No adjustment for multiple comparisons, threshold for significance is P < .05|ANCOVA|Mean difference=Drug A minus Drug B||Null hypothesis: fesoterodine treatment is not associated with greater reduction in urgency incontinence frequency compared to placebo in women diagnosed using the 3IQ|
1708104|NCT00862654|3142737|Superiority or Other|||||||0.039|||||||Cochran-Mantel-Haenszel|Each test was two-sided, at the 0.050 significance level.||The primary efficacy criterion was analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, stratified by center (or analysis-center) after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. The p-value had to be inferior to 0.05 at week 4, in the ITT/LOCF population. PP analysis was also performed to assess the robustness of the results obtained in the ITT/LOCF population.|
1708105|NCT00862654|3142737|Superiority or Other||||||<|0.01|||||||Cochran-Mantel-Haenszel|Each test was two-sided, at the 0.050 significance level.||The primary efficacy criterion was analyzed by using the Cochran-Mantel-Haenszel (CMH) statistic, stratified by center (or analysis-center) after ridit transformation with the row mean difference statistics, testing the hypothesis of equality. The p-value had to be inferior to 0.05 at week 4, in the ITT/LOCF population. PP analysis was also performed to assess the robustness of the results obtained in the ITT/LOCF population.|
1708106|NCT00862641|3142739|Superiority or Other|||||||0.8085|||||||ANCOVA|||"P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model."|
1708107|NCT00862641|3142739|Superiority or Other|||||||0.9904|||||||ANCOVA|||"P-value applies to 'Change at Hour 2'~P-value based on ranked analysis of covariance with treatment and investigator site as main effects and baseline value as a covariate in the model."|
1708108|NCT00862641|3142740|Superiority or Other|||||||0.0289|||||||ANCOVA|||P-value applies to 'Change at Hour 2'|
1708109|NCT00862641|3142740|Superiority or Other|||||||0.2087|||||||ANCOVA|||P-value applies to 'Change at Hour 2'|
1708110|NCT00862641|3142741|Superiority or Other|||||||0.0258|||||||ANCOVA|||P-value applies to 'Change at Hour 2'|
1708111|NCT00862641|3142741|Superiority or Other|||||||0.0789|||||||ANCOVA|||P-value applies to 'Change at Hour 2'|
1708112|NCT00862641|3142742|Superiority or Other|||||||0.4385|||||||ANCOVA|||P-value applies to 'Change at Hour 2'|
1708113|NCT00862641|3142742|Superiority or Other|||||||0.0015|||||||ANCOVA|||P-value applies to 'Change at Hour 2'|
1708114|NCT00862641|3142743|Superiority or Other|||||||0.6189|||||||ANCOVA|||P-value applies to 'Change at Hour 2'|
1708115|NCT00862641|3142743|Superiority or Other|||||||0.0029|||||||ANCOVA|||P-value applies to 'Change at Hour 2'|
1708116|NCT00862641|3142746|Superiority or Other|||||||0.579|||||||Cochran-Mantel-Haenszel|Analysis of treatment effect was based on the CMH test stratified by investigative site. Sites with less than 15 subjects were pooled.|||
1708117|NCT00862641|3142746|Superiority or Other|||||||0.1451|||||||Cochran-Mantel-Haenszel|Analysis of treatment effect was based on the Cochran-Mantel Haenszel(CMH) test stratified by investigative site. Sites with <15 subjects were pooled.|||
1708118|NCT00862563|3142747|Superiority or Other|||||||0.3||||||p<0.01 is considered to be significant|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction.|
1708119|NCT00862563|3142747|Superiority or Other|||||||0.0025||||||p<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction.|
1708120|NCT00862563|3142747|Superiority or Other|||||||0.038||||||p<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Spatial Span scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.|
1708121|NCT00862563|3142748|Superiority or Other|||||||0.95||||||p<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group x time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction.|
1708122|NCT00862563|3142748|Superiority or Other||||||<|0.0001||||||p<0.01 is considered to be significant.|Mixed Models Analysis|p value shown is for the group X time interaction effect.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that age adjusted Digit Span scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction.|
1708123|NCT00862563|3142748|Superiority or Other||||||<|0.07||||||p<0.01 is considered to be significant|Mixed Models Analysis|p value is for the group x time interaction effect||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that Digit span scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.|
1708181|NCT00862459|3142800|Superiority or Other||Mean Difference (Final Values)|-0.069|Standard Deviation|2.92||||95.0|-0.825|0.69|||||||
1708182|NCT00862459|3142801|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Deviation|1.59||0.844|||||||t-test, 2 sided||||
1708124|NCT00862563|3142749|Superiority or Other|||||||0.36||||||p<0.01 is considered to be significant.|Mixed Models Analysis|The p value is for the group x time interaction effect for the comparison of the levetiracetam and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in significant treatment x time interaction|
1708125|NCT00862563|3142749|Superiority or Other|||||||0.01||||||p< 0.01 is considered to be significant.|Mixed Models Analysis|The p value shown is for the group x time interaction effect for the comparison of data from the topiramate and the placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in significant treatment x time interaction|
1708126|NCT00862563|3142749|Superiority or Other|||||||0.003||||||p<0.01 is considered to be significant.|Mixed Models Analysis|p value is for the group x time interaction effect for the paired comparison of COWAT-category data for the zonisamide and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Category scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.|
1708127|NCT00862563|3142750|Superiority or Other|||||||0.3||||||p<0.01 is considered to be significant.|Mixed Models Analysis|p value is for interaction effect for the comparison of data for the levetiracetam and placebo groups.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the levetiracetam as compared to the placebo group resulting in a significant treatment x time interaction.|
1708128|NCT00862563|3142750|Superiority or Other||||||<|0.0001||||||p<0.01 is considered to be significant|Mixed Models Analysis|p value is for group x time interaction term for the comparison of data for the topiramate and placebo group.||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the topiramate as compared to the placebo group resulting in a significant treatment x time interaction.|
1708129|NCT00862563|3142750|Superiority or Other||||||<|0.0001||||||p< 0.01 is considered to be significant.|Mixed Models Analysis|p value is for the group x time interaction term.`||Data were analyzed using two-way repeated measures mixed models analysis. It was hypothesized that COWAT-Letter Fluency scores would change towards a downward direction for the zonisamide as compared to the placebo group resulting in significant treatment x time interaction.|
1708130|NCT00862563|3142751|Superiority or Other||Difference between least squares means|-18.5|Standard Error of the Mean|8.2||0.026|2-Sided|||||p< 0.05 is considered to be significant|ANOVA|||.Comparison of Week 12 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis.Baseline values were used as covariates.|
1708131|NCT00862563|3142751|Superiority or Other||Difference between least squares means|-31.2|Standard Error of the Mean|8.1||0.0002|2-Sided|||||p<0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates.|
1708132|NCT00862563|3142751|Superiority or Other||Difference between least squares means|-19.3|Standard Deviation|8.0||0.017|2-Sided|||||p<0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis. Baseline values were used as covariates.|
1708133|NCT00862563|3142751|Superiority or Other||Difference between least squares means|-34.0|Standard Error of the Mean|9.2||0.0004|2-Sided|||||p<0.05 is considered to be significant.|ANOVA|||Week 12.Comparison of Week 12 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708134|NCT00862563|3142751|Superiority or Other||Difference between least squares means|-47.6|Standard Error of the Mean|9.1|<|0.0001|2-Sided|||||p<0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708135|NCT00862563|3142751|Superiority or Other||Difference between least squares means|-38.1|Standard Error of the Mean|9.0|<|0.0001|2-Sided|||||p< 0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and topiramate. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factors. Baseline values were used as covariates.|
1708136|NCT00862563|3142751|Superiority or Other||Difference between least square means|-16.3|Standard Error of the Mean|8.0|<|0.044|2-Sided|||||p< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708137|NCT00862563|3142751|Superiority or Other||Difference between least squares means|-24.1|Standard Error of the Mean|7.9|<|0.003|2-Sided||||||ANOVA|||Comparison of Week 11 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708183|NCT00862459|3142801|Superiority or Other||Mean Difference (Final Values)|0.59|Standard Deviation|1.49||0.003|||||||t-test, 2 sided|||2 sample t-test between the dose groups|
1708184|NCT00862251|3142804|Superiority or Other||Least Squares Mean Difference|4.69||||0.494|2-Sided|95.0|-8.73|18.1|||Longitudinal data analysis (LDA)||||
1708138|NCT00862563|3142751|Superiority or Other||Difference between least squares means|-22.5|Standard Error of the Mean|7.8|<|0.005|2-Sided|||||p<0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708139|NCT00862563|3142752|Superiority or Other||Difference between least squares means|-24.8|Standard Error of the Mean|10.3||0.018|2-Sided|||||p<0.05 is considered to be significant|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708140|NCT00862563|3142752|Superiority or Other||Difference between least squares means|-23.3|Standard Error of the Mean|10.2||0.025|2-Sided|||||p< 0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708141|NCT00862563|3142752|Superiority or Other||Difference between least squares means|-20.7|Standard Error of the Mean|10.0||0.04|2-Sided|||||p< 0.05 is considered to be significant|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and levetiracetam groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708142|NCT00862563|3142752|Superiority or Other||Difference between least squares means|-37.7|Standard Error of the Mean|9.3|<|0.0001|2-Sided|||||p<0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708143|NCT00862563|3142752|Superiority or Other||Difference between least squares means|-29.7|Standard Error of the Mean|9.2|<|0.0015|2-Sided|||||p< 0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708144|NCT00862563|3142752|Superiority or Other||Difference between least squares means|-33.0|Standard Error of the Mean|9.0|<|0.0004|2-Sided|||||p<0.05 is considered to be significant.|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and topiramate groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708145|NCT00862563|3142752|Superiority or Other||Difference between least squares means|-22.8|Standard Error of the Mean|9.9|<|0.24|2-Sided|||||p< 0.05 is considered to be significant|ANOVA|||Comparison of Week 12 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708146|NCT00862563|3142752|Superiority or Other||Difference between least squares means|-20.9|Standard Error of the Mean|9.8|<|0.036|2-Sided|||||p<0.05 is considered to be significant|ANOVA|||Comparison of Week 11 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708147|NCT00862563|3142752|Superiority or Other||Difference between least squares means|-24.4|Standard Error of the Mean|9.7|<|0.013|2-Sided|||||p< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 10 means for mean percent heavy drinking days obtained for the placebo and zonisamide groups Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708148|NCT00862563|3142753|Superiority or Other||Mean difference Week 12|3.65|Standard Error of the Mean|3.3||0.264|2-Sided|||||p< 0.05 is considered to be significant.|ANOVA|||Comparison of means for the levetiracetam and placebo groups for Week 12. Model generated least mean squares were used for this analysis.|
1708149|NCT00862563|3142753|Superiority or Other||Mean Difference Week 12|0.98|Standard Error of the Mean|3.6||0.784|2-Sided|||||p< 0.05 is considered to be significant.|ANOVA|||Comparison of means for the zonisamide and placebo group for Week 12. Mixed models generated means were used in this analysis.|
1708150|NCT00862563|3142753|Superiority or Other||Mean difference Week 12|8.9|Standard Error of the Mean|3.6||0.015|2-Sided|||||p< 0.05 is considered to be significant.|ANOVA|||Comparison between mean values obtained for the topiramate and placebo groups for Week 12. Model generated least mean squares were used for this analysis.|
1708151|NCT00862563|3142754|Superiority or Other||Difference between least squares means|-2.0|Standard Error of the Mean|1.2||0.1|2-Sided|||||p< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 12 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means s from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708185|NCT00862251|3142804|Superiority or Other||Least Squares Mean Difference|-2.78||||0.749|2-Sided|95.0|-19.88|14.32|||Longitudinal data analysis (LDA)||||
1708186|NCT00862251|3142805|Superiority or Other||Least Squares Mean Difference|-2.52||||0.175|2-Sided|95.0|-6.17|1.13|||Longitudinal data analysis (LDA)||||
1708270|NCT00861705|3142908|Superiority or Other (legacy)|||||||0.0029|||||||Chi-squared|Reported p-values are unadjusted and 1-sided|||
1708152|NCT00862563|3142754|Superiority or Other||Difference between least squares means|-2.9|Standard Error of the Mean|1.2||0.014|2-Sided|||||p< 0.05 is considered to be significant.|ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariate values.|
1708153|NCT00862563|3142754|Superiority or Other||Difference between least squares means|-1.64|Standard Error of the Mean|1.1||0.15|2-Sided|||||p<0.05 considered to be significant|ANOVA|||Comparison of Week 10 means for mean drinks per day obtained for the placebo and levetiracetam groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708154|NCT00862563|3142754|Superiority or Other||Difference between least squares means|-4.1|Standard Error of the Mean|1.2||0.0007|2-Sided||||||ANOVA|||Comparison of Week 12 means for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708155|NCT00862563|3142754|Superiority or Other||Difference between least squares means|-4.4|Standard Error of the Mean|1.1||0.0002|2-Sided||||||ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates. .|
1708156|NCT00862563|3142754|Superiority or Other||Difference between least squares means.|-3.4|Standard Error of the Mean|1.1||0.003|2-Sided|||||p<0.05 is considered as being significant.|ANOVA|||Comparison of Week 10 mean for mean drinks per day obtained for the placebo and topiramate groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates,|
1708157|NCT00862563|3142754|Superiority or Other||Difference between least squares means|-2.1|Standard Error of the Mean|1.2||0.07|2-Sided|||||p< 0.05 was considered to be significant.|Mixed Models Analysis|||Comparison of Week 12 mean for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708158|NCT00862563|3142754|Superiority or Other||Difference between least squares means|-3.0|Standard Error of the Mean|1.1||0.008|2-Sided|||||p< 0.05 was considered to be significant.|ANOVA|||Comparison of Week 11 means for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least squares means from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708159|NCT00862563|3142754|Superiority or Other||Difference between least squares means|-2.1|Standard Error of the Mean|1.1||0.06|2-Sided|||||p<0.05 considered to be significant|ANOVA|||Comparison of Week 10 means for mean drinks per day obtained for the placebo and zonisamide groups. Means used for the analysis are least means squares from a two-way repeated measures mixed models analysis, with Week (time) as the the within subject factor and treatment as the between group factor. Baseline values were used as covariates.|
1708160|NCT00862459|3142790|Superiority or Other||difference in accuracy|-5.29||||0.45||95.0|-18.83|8.24|||Chi-squared|adjusted for clustering|||
1708161|NCT00862459|3142790|Superiority or Other||difference in accuracy|18.46||||0.02||95.0|3.15|33.77|||Chi-squared|adjusted for clustering|||
1708162|NCT00862459|3142791|Superiority or Other||difference in accuracy|-18.37||||0.02||95.0|-33.6|-1.35|||Chi-squared|adjusted for clustering|||
1708163|NCT00862459|3142791|Superiority or Other||difference in accuracy|12.91||||0.07||95.0|-1.44|27.26|||Chi-squared|adjusted for clustering|||
1708164|NCT00862459|3142792|Superiority or Other||difference in accuracy|-10.75||||0.13||95.0|-24.41|2.9|||Chi-squared|adjusted for clustering|||
1708165|NCT00862459|3142792|Superiority or Other||difference in accuracy|24.63||||0.02||95.0|5.39|43.86|||Chi-squared|adjusted for clustering|||
1708166|NCT00862459|3142793|Superiority or Other||difference in accuracies|2.87||||0.55||95.0|-6.59|12.32|||Chi-squared|adjusted for clustering|||
1708167|NCT00862459|3142793|Superiority or Other||difference in accuracy|-6.13||||0.11||95.0|-13.73|1.48|||Chi-squared|adjusted for clustering|||
1708168|NCT00862459|3142794|Superiority or Other||difference in accuracies|-13.58||||0.02||95.0|-25.07|-2.09|||Chi-squared|adjusted for clustering|||
1708169|NCT00862459|3142794|Superiority or Other||difference in accuracy|13.43||||0.03||95.0|1.53|25.33|||Chi-squared|adjusted for clustering|||
1708170|NCT00862459|3142795|Superiority or Other||difference in accuracies|-10.75|Standard Error of the Mean|6.83||0.13||95.0|-24.41|2.9|||Chi-squared|adjusted for clustering|||
1708171|NCT00862459|3142795|Superiority or Other||accuracy difference|1.66|Standard Error of the Mean|6.29||0.8||95.0|-10.93|14.24|||Chi-squared|Adjusted for clustering|||
1708172|NCT00862459|3142796|Superiority or Other||Mean Difference (Final Values)|4.74|Standard Deviation|77.11||||95.0|-15.86|25.35|||||||
1708173|NCT00862459|3142796|Superiority or Other||Mean Difference (Final Values)|-17.54|Standard Deviation|76.45||||95.0|-37.11|2.02||||||difference in CNR between doses and confidence interval|
1708174|NCT00862459|3142797|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Deviation|0.76||||95.0|-0.1|0.31|||||||
1708175|NCT00862459|3142797|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Deviation|0.76||||95.0|-0.58|-0.18|||||||
1708176|NCT00862459|3142798|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Deviation|1.01||||95.0|-0.25|0.22|||||||
1708177|NCT00862459|3142798|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Deviation|0.86||||95.0|-0.619|-0.17|||||||
1708178|NCT00862459|3142799|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Deviation|1.57||||95.0|-0.44|0.41|||||||
1708187|NCT00862251|3142805|Superiority or Other||Least Squares Mean Difference|-8.91|||<|0.001|2-Sided|95.0|-13.36|-4.47|||Longitudinal data analysis (LDA)||||
1708188|NCT00862251|3142806|Superiority or Other||Least Squares Mean Difference|-0.22||||0.832|2-Sided|95.0|-2.27|1.83|||Longitudinal data analysis (LDA)||||
1708189|NCT00862251|3142806|Superiority or Other||Least Squares Mean Difference|1.57||||0.218|2-Sided|95.0|-0.93|4.06|||Longitudinal data analysis (LDA)||||
1708190|NCT00862251|3142807|Superiority or Other||Least Squares Mean Difference|-2.95||||0.041|2-Sided|95.0|-5.78|-0.12|||Longitudinal data analysis (LDA)||||
1708191|NCT00862251|3142807|Superiority or Other||Least Squares Mean Difference|-8.01|||<|0.001|2-Sided|95.0|-11.46|-4.56|||Longitudinal data analysis (LDA)||||
1708192|NCT00862251|3142808|Superiority or Other||Least Squares Mean Difference|-2.13||||0.371|2-Sided|95.0|-6.81|2.54|||Longitudinal data analysis (LDA)||||
1708193|NCT00862251|3142808|Superiority or Other||Least Squares Mean Difference|-11.45|||<|0.001|2-Sided|95.0|-17.16|-5.75|||Longitudinal data analysis (LDA)||||
1708194|NCT00862251|3142809|Superiority or Other||Least Squares Mean Difference|-1.83||||0.266|2-Sided|95.0|-5.05|1.4|||Longitudinal data analysis (LDA)||||
1708195|NCT00862251|3142809|Superiority or Other||Least Squares Mean Difference|-8.17|||<|0.001|2-Sided|95.0|-12.1|-4.23|||Longitudinal data analysis (LDA)||||
1708196|NCT00862251|3142810|Superiority or Other||Least Sqares Mean Difference|-2.56||||0.313|2-Sided|95.0|-7.53|2.41|||Longitudinal data analysis (LDA)||||
1708197|NCT00862251|3142810|Superiority or Other||Least Squares Mean Difference|-14.16|||<|0.001|2-Sided|95.0|-20.23|-8.1|||Longitudinal data analysis (LDA)||||
1708198|NCT00862251|3142811|Superiority or Other||Least Squares Mean Difference|-3.18||||0.078|2-Sided|95.0|-6.71|0.35|||Longitudinal data analysis (LDA)||||
1708199|NCT00862251|3142811|Superiority or Other||Least Squares Mean Difference|-11.62|||<|0.001|2-Sided|95.0|-15.93|-7.31|||Longitudinal data analysis (LDA)||||
1708200|NCT00862251|3142812|Superiority or Other||Least Sqares Mean Difference|-0.52||||0.675|2-Sided|95.0|-2.96|1.92|||Longitudinal data analysis (LDA)||||
1708201|NCT00862251|3142812|Superiority or Other||Least Squares Mean Difference|0.47||||0.756|2-Sided|95.0|-2.5|3.45|||Longitudinal data analysis (LDA)||||
1708202|NCT00862251|3142813|Superiority or Other||Least Squares Mean Difference|-2.16||||0.356|2-Sided|95.0|-6.75|2.43|||Longitudinal data analysis (LDA)||||
1708203|NCT00862251|3142813|Superiority or Other||Least Squares Mean Difference|-2.88||||0.316|2-Sided|95.0|-8.53|2.77|||Longitudinal data analysis (LDA)||||
1708204|NCT00862251|3142814|Superiority or Other||Least Squares Mean Difference|-2.63||||0.039|2-Sided|95.0|-5.13|-0.13|||Longitudinal data analysis (LDA)||||
1708205|NCT00862251|3142814|Superiority or Other||Least Squares Mean Difference|-8.33|||<|0.001|2-Sided|95.0|-11.38|-5.28|||Longitudinal data analysis (LDA)||||
1708206|NCT00862251|3142815|Superiority or Other||Odds Ratio (OR)|3.5|||<|0.001|2-Sided|95.0|1.9|6.6|||Regression, Logistic||||
1708207|NCT00862251|3142816|Superiority or Other||Odds Ratio (OR)|4.5|||<|0.001|2-Sided|95.0|2.3|8.5|||Regression, Logistic||||
1708208|NCT00862251|3142817|Superiority or Other||Odds Ratio (OR)|1.9|||<|0.001|2-Sided|95.0|1.3|2.6|||Regression, Logistic||||
1708209|NCT00862251|3142817|Superiority or Other||Odds Ratio (OR)|3.9|||<|0.001|2-Sided|95.0|2.5|6.2|||Regression, Logistic||||
1708210|NCT00862251|3142818|Superiority or Other||Percent Change in Least Squares Means|-3.81||||0.06|2-Sided|95.0|-7.78|0.17|||Longitudinal Data Analysis||||
1708211|NCT00862251|3142819|Superiority or Other||Percent change in least squares mean|-15.73|||<|0.001|2-Sided|95.0|-22.65|-8.81|||Longitudinal Data Analysis (LDA)||||
1708212|NCT00862251|3142820|Superiority or Other||Percent change in Least Square Means|-13.62|||<|0.001|2-Sided|95.0|-20.44|-6.79|||Longitudinal data analysis (LDA)||||
1708213|NCT00862251|3142821|Superiority or Other||Percent change in least-square means|-14.76|||<|0.001|2-Sided|95.0|-19.61|-9.91|||Longitudinal data analysis (LDA)||||
1708214|NCT00862121|3142831|Superiority or Other||Odds Ratio (OR)|0.212||||0.231|2-Sided|95.0|0.017|2.683|||Regression, Logistic|||The odds ratio (OR) for Baseline CDAI measures the effect of an increase of one unit on the outcome. The OR [95% CI] and p-value (likelihood-based) are for Pentasa versus placebo estimated in a logistic regression analysis including TREATMENT and CDAI at baseline as covariates. Power to demonstrate superiority of PENTASA Sachet 6 g/day over placebo in the primary efficacy analysis was 90% for a planned sample size of 255 participants per treatment arm (assuming 10% nonassessable participants).|
1708215|NCT00861757|3142845|Superiority or Other|||||||0.409|||||||Wilcoxon rank-sum test||||
1708216|NCT00861757|3142845|Superiority or Other|||||||0.838|||||||Wilcoxon rank-sum test||||
1708217|NCT00861757|3142845|Superiority or Other|||||||0.33|||||||Wilcoxon rank-sum test||||
1708218|NCT00861757|3142846|Superiority or Other|||||||0.278||||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test||||
1708219|NCT00861757|3142846|Superiority or Other|||||||0.054||||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test||||
1708220|NCT00861757|3142846|Superiority or Other|||||||0.005||||||This is the p value for diastolic blood pressure.|Wilcoxon rank-sum test||||
1708221|NCT00861757|3142846|Superiority or Other|||||||0.273||||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test||||
1708222|NCT00861757|3142846|Superiority or Other|||||||0.723||||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test||||
1708223|NCT00861757|3142846|Superiority or Other|||||||0.007||||||This is the p value for systolic blood pressure.|Wilcoxon rank-sum test||||
1708224|NCT00861757|3142847|Superiority or Other|||||||0.524||||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)||||
1708225|NCT00861757|3142847|Superiority or Other|||||||0.216||||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)||||
1708226|NCT00861757|3142847|Superiority or Other|||||||0.008||||||This is the p value for diastolic blood pressure.|Wilcoxon (Mann-Whitney)||||
1708227|NCT00861757|3142847|Superiority or Other|||||||0.538||||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)||||
1709148|NCT00852995|3144527|Superiority or Other|||||||0.2317||||||Visit 12|Cochran-Mantel-Haenszel||||
1708229|NCT00861757|3142847|Superiority or Other|||||||0.005||||||This is the p value for systolic blood pressure.|Wilcoxon (Mann-Whitney)||||
1708230|NCT00861757|3142848|Superiority or Other|||||||0.212|||||||Wilcoxon (Mann-Whitney)||||
1708231|NCT00861757|3142848|Superiority or Other|||||||0.51|||||||Wilcoxon (Mann-Whitney)||||
1708232|NCT00861757|3142848|Superiority or Other|||||||0.688|||||||Wilcoxon (Mann-Whitney)||||
1708233|NCT00861757|3142849|Superiority or Other|||||||0.456|||||||Wilcoxon (Mann-Whitney)||||
1708234|NCT00861757|3142849|Superiority or Other|||||||0.083|||||||Wilcoxon (Mann-Whitney)||||
1708235|NCT00861757|3142849|Superiority or Other|||||||0.412|||||||Wilcoxon (Mann-Whitney)||||
1708236|NCT00861757|3142850|Superiority or Other|||||||0.001||||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 0.2 mg Tamsulosin) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel||||
1708237|NCT00861757|3142850|Superiority or Other|||||||0.002||||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel||||
1708238|NCT00861757|3142850|Superiority or Other|||||||0.034||||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the CGI-I.|Cochran-Mantel-Haenszel||||
1708239|NCT00861757|3142851|Superiority or Other||||||<|0.001||||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (placebo vs 0.2 mg Tamsulosin) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel||||
1708240|NCT00861757|3142851|Superiority or Other||||||<|0.001||||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 5.0 mg Tadalafil) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel||||
1708241|NCT00861757|3142851|Superiority or Other||||||<|0.001||||||The p-value came from the Cochran-Mantel-Haenszel test to assess if there was any association between treatment (that is, placebo vs 2.5 mg Tadalafil) and 7 categories of the PGI-I.|Cochran-Mantel-Haenszel||||
1708242|NCT00861757|3142852|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.5||0.94|2-Sided|95.0|-1.1|1.0|||ANCOVA||||
1708243|NCT00861757|3142852|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.5||0.14|2-Sided|95.0|-1.8|0.3|||ANCOVA||||
1708244|NCT00861757|3142852|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.5||0.331|2-Sided|95.0|-1.6|0.5|||ANCOVA||||
1708245|NCT00861757|3142853|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.3||0.007|2-Sided|95.0|-1.4|-0.2|||ANCOVA||||
1708246|NCT00861757|3142853|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.3||0.393|2-Sided|95.0|-0.8|0.3|||ANCOVA||||
1708247|NCT00861757|3142853|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.3||0.201|2-Sided|95.0|-1.0|0.2|||ANCOVA||||
1708248|NCT00861757|3142854|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.9|-0.4|||ANCOVA||||
1708249|NCT00861757|3142854|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1|<|0.013|2-Sided|95.0|-0.6|-0.1|||ANCOVA||||
1708250|NCT00861757|3142854|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1|<|0.031|2-Sided|95.0|-0.6|0.0|||ANCOVA||||
1708251|NCT00861757|3142855|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.3||0.023|2-Sided|95.0|-1.1|-0.1||This is the p value for the Storage (Irritative) Score.|ANCOVA||||
1708252|NCT00861757|3142855|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.3||0.021|2-Sided|95.0|-1.1|-0.1||This is the p value for the Storage (Irritative) Score.|ANCOVA||||
1708253|NCT00861757|3142855|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.3||0.072|2-Sided|95.0|-1.0|0.0||This is the p value for the Storage (Irritative) Score.|ANCOVA||||
1708254|NCT00861757|3142855|Superiority or Other||Mean Difference (Final Values)|-1.9|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-2.7|-1.1||This is the p value for the Voiding (Obstructive) Score.|ANCOVA||||
1708255|NCT00861757|3142855|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.4|<|0.005|2-Sided|95.0|-1.9|-0.3||This is the p value for the Voiding (Obstructive) Score.|ANCOVA||||
1708256|NCT00861757|3142855|Superiority or Other||Mean Difference (Final Values)|-1.4|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-2.2|-0.6||This is the p value for the Voiding (Obstructive) Score.|ANCOVA||||
1708257|NCT00861757|3142856|Superiority or Other||Mean Difference (Final Values)|-2.5|Standard Error of the Mean|0.6|<|0.001|2-Sided|95.0|-3.7|-1.3|||ANCOVA||||
1708258|NCT00861757|3142856|Superiority or Other||Mean Difference (Final Values)|-1.7|Standard Error of the Mean|0.6|<|0.004|2-Sided|95.0|-2.9|-0.6|||ANCOVA||||
1708259|NCT00861757|3142856|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|0.6|<|0.003|2-Sided|95.0|-3.0|-0.6|||ANCOVA||||
1708260|NCT00861705|3142901|Superiority||Hazard Ratio (HR)|0.95|||||2-Sided|95.0|0.53|1.7|||||||
1708261|NCT00861705|3142901|Superiority||Hazard Ratio (HR)|1.24|||||2-Sided|95.0|0.72|2.16|||||||
1708262|NCT00861705|3142901|Superiority||Hazard Ratio (HR)|1.16|||||2-Sided|95.0|0.66|2.03|||||||
1708263|NCT00861705|3142902|Superiority||Cox Proportional Hazard|0.82|||||2-Sided|95.0|0.49|1.37|||||||
1708264|NCT00861705|3142902|Superiority||Cox Proportional Hazard|1.2|||||2-Sided|95.0|0.74|1.92|||||||
1708265|NCT00861705|3142902|Superiority||Cox Proportional Hazard|1.08|||||2-Sided|95.0|0.66|1.75|||||||
1708266|NCT00861705|3142903|Superiority||Cox Proportional Hazard|0.82|||||2-Sided|95.0|0.49|1.37|||||||
1708267|NCT00861705|3142903|Superiority||Cox Proportional Hazard|1.43|||||2-Sided|95.0|0.82|2.47|||||||
1708268|NCT00861705|3142903|Superiority||Cox Proportional Hazard|1.19|||||2-Sided|95.0|0.67|2.1|||||||
1708269|NCT00861705|3142907|Superiority or Other (legacy)|||||||0.057|||||||Chi-squared|Reported p-values are unadjusted and 1-sided|||
1709149|NCT00852995|3144527|Superiority or Other|||||||0.506||||||Visit 12|Cochran-Mantel-Haenszel||||
1708271|NCT00861705|3142909|Superiority or Other (legacy)|||||||0.0089|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in > 95% power.|
1708272|NCT00861705|3142910|Superiority or Other (legacy)|||||||0.0018|||||||Chi-squared|Reported p-values are unadjusted and 1-sided||The study was designed to detect an increase in the incidence of pCR from 35% in the control arm to 55% in the experimental arm using a 1-sided chi square test of proportions. With a target sample of 362 patients and assuming a 10% dropout rate, an overall assessable sample size of 326 patients resulted in > 95% power.|
1708273|NCT00861614|3142927|Superiority or Other||Hazard Ratio (HR)|0.25|||||2-Sided|95.0|0.02|4.0|||||Ipilimumab over placebo||
1708274|NCT00861614|3142929|Superiority or Other||Hazard Ratio (HR)|0.7|||||2-Sided|95.0|0.61|0.82|||||Ipilimumab over placebo||
1708275|NCT00861614|3142931|Superiority or Other||Hazard Ratio (HR)|0.83||||0.0127|2-Sided|95.0|0.71|0.96|||Log Rank||Ipilimumab over placebo||
1708276|NCT00861601|3142946|Superiority or Other|||||||0.0846||||||Onset of response at the higher dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.|||
1708277|NCT00861601|3142946|Superiority or Other|||||||0.0066||||||Saturation at the medium dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.|||
1708278|NCT00861601|3142946|Superiority or Other|||||||0.0116||||||Linearity. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.|||
1708279|NCT00861601|3142947|Superiority or Other|||||||0.0808||||||Onset of response at the higher dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.|||
1708280|NCT00861601|3142947|Superiority or Other|||||||0.0057||||||Saturation at the medium dose. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.|||
1708281|NCT00861601|3142947|Superiority or Other|||||||0.0104||||||Linearity. This analysis is based on each participants' change in platelet count.|ANCOVA|No adjustment for multiplicity was made because this analysis was exploratory.|||
1708282|NCT00861146|3142958|Superiority or Other (legacy)||||||<|0.001|||||||Chi-squared|df=1|||
1708283|NCT00861146|3142959|Superiority or Other (legacy)||mixed model regression analyses (F)|2.04|||>|0.15|||||||mixed model regression analyses|||Drinking outcomes assessed using the timeline follow-back were evaluated with mixed model regression analyses using maximum likelihood estimation. Time was measured in three monthly periods and treated as a repeated factor (due to the fixed time period between estimates).|
1708284|NCT00861146|3142960|Superiority or Other (legacy)||||||<|0.01|||||||Chi-squared|df = 1|||
1708285|NCT00860795|3142968|Superiority or Other|||||||0.61|||||||Regression, Linear||||
1708286|NCT00860795|3142969|Superiority or Other|||||||0.43|||||||Regression, Linear||||
1708287|NCT00860795|3142970|Superiority or Other|||||||0.51|||||||Regression, Linear||||
1708288|NCT00860795|3142972|Superiority or Other|||||||0.2|||||||Regression, Linear||||
1708289|NCT00860795|3142973|Superiority or Other|||||||0.72|||||||Regression, Linear||||
1708290|NCT00860795|3142974|Superiority or Other|||||||0.17|||||||Regression, Linear||||
1708291|NCT00860743|3142975|Superiority or Other|||||||0.2|||||||ANOVA||||
1708292|NCT00860743|3142976|Superiority or Other|||||||0.001||||||P values less than 0.05 are considered statistically significant in this study.|ANOVA||||
1708293|NCT00860470|3142979|Superiority or Other||Risk Ratio (RR)|0.98||||0.13|2-Sided|95.0|0.96|1.01|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.||
1708294|NCT00860470|3142980|Superiority or Other||Risk Ratio (RR)|0.88|||<|0.001|2-Sided|95.0|0.85|0.91|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.||
1708295|NCT00860470|3142981|Superiority or Other||Risk Ratio (RR)|0.87||||0.87|2-Sided|95.0|0.81|0.93|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.||
1708296|NCT00860470|3142982|Superiority or Other||Risk Ratio (RR)|0.73|||<|0.001|2-Sided|95.0|0.62|0.86|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.||
1708297|NCT00860470|3142983|Superiority or Other||Risk Ratio (RR)|0.75||||0.03|2-Sided|95.0|0.57|0.97|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.||
1708298|NCT00860470|3142984|Superiority or Other||Risk Ratio (RR)|0.85|||<|0.001|2-Sided|95.0|0.8|0.91|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.||
1708299|NCT00860470|3142985|Superiority or Other||Risk Ratio (RR)|0.89||||0.02|2-Sided|95.0|0.81|0.99|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.||
1708300|NCT00860470|3142986|Superiority or Other||Risk Ratio (RR)|0.81||||0.11|2-Sided|95.0|0.63|1.04|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.||
1708395|NCT00858208|3143286|Superiority or Other|||||||0.4718|||||||paired t-test|||Change from baseline at Week 54|
1708301|NCT00860470|3142987|Superiority or Other||Risk Ratio (RR)|0.98||||0.78|2-Sided|95.0|0.88|1.2|||Regression, Logistic||GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.||
1708302|NCT00860470|3142988|Superiority or Other||Risk Ratio (RR)|0.95||||0.36|2-Sided|95.0|0.86|1.06|||Regression, Logistic|Bonferroni-adjusted alpha=0.01 (for 5 comparisons)|GEE with log link function and exchangeable correlation was used to adjust confidence intervals for cluster randomised design; the iron-folic acid supplemented group was the referent.||
1708303|NCT00860405|3142998|Non-Inferiority or Equivalence|Assuming a coefficient of variation of 0.363 and a desired power of 90 % with a type I level of 2.5 %, N=11 patients per treatment group were needed. The power was calculated by means of the software SAS, version 9.1.3, PROC POWER. Nevertheless, more patients were required for the assessment of safety, therefore 2 × 30 patients were planned to be included in this study.|Ratio of LS-means|0.98|||||2-Sided|95.0|0.84|1.16|||||Considered ratio: μVoluven/μHSA = LS-mean of Voluven®/LS-mean of HSA 5%|The aim of the study was to prove equivalence, i.e. H0: μVoluven/μHSA ≤ 0.55 or μVoluven/μHSA ≥ 1.82 H1: 0.55 < μVoluven/μHSA < 1.82 where μVoluven was the mean infused volume of Voluven® and μHSA was the mean infused volume of HSA 5%.|
1708304|NCT00860262|3143033|Superiority or Other||Mean Difference (Final Values)|-3.3|Standard Error of the Mean|1.23||0.0077|2-Sided|95.0|-5.7|-0.9|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg||
1708305|NCT00860262|3143033|Superiority or Other||Mean Difference (Final Values)|-6.4|Standard Error of the Mean|1.23|<|0.0001|2-Sided|95.0|-8.8|-4.0|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg||
1708306|NCT00860262|3143034|Superiority or Other||Mean Difference (Final Values)|-4.6|Standard Error of the Mean|1.21||0.0001|2-Sided|95.0|-7.0|-2.3|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg||
1708307|NCT00860262|3143034|Superiority or Other||Mean Difference (Final Values)|-7.8|Standard Error of the Mean|1.2|<|0.0001|2-Sided|95.0|-10.2|-5.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg||
1708308|NCT00860262|3143035|Superiority or Other||Mean Difference (Final Values)|-4.8|Standard Error of the Mean|1.24||0.0001|2-Sided|95.0|-7.2|-2.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg||
1708309|NCT00860262|3143035|Superiority or Other||Mean Difference (Final Values)|-10.2|Standard Error of the Mean|1.24|<|0.0001|2-Sided|95.0|-12.6|-7.7|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg||
1708310|NCT00860262|3143036|Superiority or Other||Mean Difference (Final Values)|-4.8|Standard Error of the Mean|1.24||0.0001|2-Sided|95.0|-7.3|-2.4|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg||
1708311|NCT00860262|3143036|Superiority or Other||Mean Difference (Final Values)|-10.6|Standard Error of the Mean|1.25|<|0.0001|2-Sided|95.0|-13.1|-8.2|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus telmisartan 80 mg||
1708312|NCT00860262|3143037|Superiority or Other||Mean Difference (Final Values)|-4.4|Standard Error of the Mean|1.18||0.0002|2-Sided|95.0|-6.7|-2.1|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus amlodipine 10 mg||
1708313|NCT00860262|3143037|Superiority or Other||Mean Difference (Final Values)|-10.6|Standard Error of the Mean|1.18|<|0.0001|2-Sided|95.0|-12.9|-8.3|||Repeated measures ANCOVA||Difference calculated as T80+A10 minus Telmisartan 80 mg||
1708314|NCT00860249|3143038|Superiority or Other||||||<|0.017||||||We intended to use a Bonferroni calculation to adjust for multiple comparisons among study arms.|Chi-squared|||Please note that no analyses were performed as the trial was stopped due to low enrollment.|
1708315|NCT00860249|3143039|Superiority or Other||||||<|0.017||||||We used the Bonferroni calculation to adjust for the planned multiple comparisons among the three groups.|Chi-squared|||Please note that no analyses were performed as the trial was stopped due to low enrollment.|
1708316|NCT00860067|3143075|Non-Inferiority or Equivalence|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose B/Victoria GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj > 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Victoria post-dose GMT ratio: (FluMist B/Victoria) divided by (Q/LAIV B/Victoria).|Ratio of geometric means|0.92|||||2-Sided|95.0|0.82|1.03||||||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Victoria GMTs for the specified comparison. Geometric mean titers for the B/Victoria influenza antibody measurements were calculated as: GMT = antilog^e (mean [log^e x]) where x was the assay result and e was the natural logarithm.|
1708317|NCT00860067|3143075|Non-Inferiority or Equivalence|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose B/Yamagata GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj > 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the B/Yamagata post-dose GMT ratio: (FluMist B/Yamagata) divided by (Q/LAIV B/Yamagata).|Ratio of geometric mean|1.1|||||2-Sided|95.0|0.97|1.25||||||Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of B/Yamagata GMTs for the specified comparison. Geometric mean titers for the B/Yamagata influenza antibody measurements were calculated as: GMT = antilog^e (mean [log^e x]) where x was the assay result and e was the natural logarithm.|
1708318|NCT00860067|3143075|Non-Inferiority or Equivalence|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose A/H3N2 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj > 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H3N2 post-dose GMT ratio: (FluMist B/Yamagata A/H3N2 + FluMist B/Victoria A/H3N2) divided by Q/LAIV A/H3N2.|Ratio of geometric means|1.05|||||2-Sided|95.0|0.96|1.14||||||A/H3N2: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H3N2 GMTs for the specified comparison. Geometric mean titers for the A/H3N2 influenza antibody measurements were calculated as: GMT = antilog^e (mean [log^e x]) where x was the assay result and e was the natural logarithm.|
1708358|NCT00858442|3143249|Non-Inferiority or Equivalence|"Applies normality test of shapiro Wilks=0.822, P<0.001 in group without PRP, and in PRP group shapiro Wilks =0.910, P<0.017.~The data were no normally distributed, with equal variances (Test of levene, F=1.324, P>0.255)"|||||>|0.398|||||||Wilcoxon (Mann-Whitney)|Mean rank group without PRP= 28.88 Mean rank group with PRP= 26.31 Z value = -0.027|||
1708319|NCT00860067|3143075|Non-Inferiority or Equivalence|The immune response of Q/LAIV was to be declared noninferior to that of trivalent FluMist if the upper bound of the 95% CI for post dose A/H1N1 GMT ratio was ≤ 1.5. This corresponded to the statistical hypothesis of: Ho: Rj > 1.5 for any j and Ha: Rj ≤ 1.5 for all j, where Rj was the A/H1N1 post-dose GMT ratio: (FluMist B/Yamagata A/H1N1 + FluMist B/Victoria A/H1N1) divided by Q/LAIV A/H1N1.|Ratio of geometric mean|1.09|||||2-Sided|95.0|1.01|1.18||||||A/H1N1: Noninferior immune response was assessed by evaluating the upper bound of the 2-sided 95% CI for the ratio of A/H1N1 GMTs for the specified comparison. Geometric mean titers for the A/H1N1 influenza antibody measurements were calculated as: GMT = antilog^e (mean [log^e x]) where x was the assay result and e was the natural logarithm.|
1708320|NCT00860028|3143076|Superiority or Other|||||||0.03|||||||Fisher Exact||||
1708321|NCT00860028|3143077|Superiority or Other|||||||0.06|||||||General Linear Model||||
1708322|NCT00860028|3143078|Superiority or Other|||||||0.36|||||||Chi-squared||||
1708323|NCT00859976|3143083|Superiority|A superiority test was used to calculate the number of patients that are needed in order to show a difference between the bone mineral density surrounding BoneMaster coated cups compared to plasma HA sprayed cups.||||||0.457|||||||Wilcoxon (Mann-Whitney)|Change in bone mineral density, normalised to baseline levels.|||
1708324|NCT00859898|3143096|Superiority or Other||Mean Difference (Final Values)|-1.37|Standard Error of the Mean|0.3362|<|0.0001|2-Sided|95.0|-2.03|-0.71||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline value as a covariate||Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.|
1708325|NCT00859898|3143096|Superiority or Other||Mean Difference (Final Values)|-1.97|Standard Error of the Mean|0.3401|<|0.0001|2-Sided|95.0|-2.64|-1.3||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.|
1708326|NCT00859898|3143097|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.1817||0.0036|2-Sided|95.0|-0.89|-0.18||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.|
1708327|NCT00859898|3143097|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.1807||0.0133|2-Sided|95.0|-0.81|-0.09||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|: treatment group as an effect and the baseline HbA1c value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical testing was only performed if the dapagliflozin 10 mg plus metformin XR group was statistically significantly superior to both control groups for the primary efficacy endpoint. Tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.|
1708328|NCT00859898|3143098|Superiority or Other||Mean Difference (Final Values)|11.3|Standard Error of the Mean|4.73||0.0165|2-Sided|95.0|2.1|20.6||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).|
1708329|NCT00859898|3143098|Superiority or Other||Mean Difference (Final Values)|14.9|Standard Error of the Mean|4.598||0.0012|2-Sided|95.0|5.9|23.9||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).|
1708330|NCT00859898|3143099|Superiority or Other||Mean Difference (Final Values)|-11.6|Standard Error of the Mean|3.566||0.0012|2-Sided|95.0|-18.6|-4.6||two-sided significance level at α=0.05.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||When testing for superiority, significance is claimed only if dapagliflozin 10 mg is superior to metformin XR|
1708331|NCT00859898|3143099|Non-Inferiority or Equivalence|The non-inferiority of dapagliflozin 10 mg versus metformin XR was demonstrated when the upper limit of the two-sided 95% confidence interval of the difference in change FPG from baseline to Week 24 (LOCF) between dapagliflozin 10 mg and metformin XR was less than 15 mg/dL.|Mean Difference (Final Values)|-11.6|Standard Error of the Mean|3.566|||2-Sided|95.0|-18.6|-4.6|||||||
1708332|NCT00859898|3143099|Superiority or Other||Mean Difference (Final Values)|-25.5|Standard Error of the Mean|3.59|<|0.0001|2-Sided|95.0|-32.6|-18.5||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.|
1708333|NCT00859898|3143099|Superiority or Other||Mean Difference (Final Values)|-13.9|Standard Error of the Mean|3.558|<|0.0001|2-Sided|95.0|-20.9|-7.0||two-sided significance level at α=0.05. Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant.|ANCOVA|treatment group as an effect and the baseline value as a covariate.||A hierarchical closed testing procedure was implemented to control the familywise type I error rate related to this endpoint at the two-sided 0.05 level. Statistical tests were only performed for a given secondary endpoint if all previous sequential tests versus that treatment group were also significant.|
1708334|NCT00859898|3143100|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.1054||0.9144|2-Sided|95.0|-0.22|0.2||two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.||When testing for superiority, significance is claimed only if dapagliflozin 10 mg is superior to metformin XR|
1708335|NCT00859898|3143100|Non-Inferiority or Equivalence|The non-inferiority of dapagliflozin 10 mg versus metformin XR was demonstrated when the upper limit of the two-sided 95% confidence interval of the difference in change in HbA1c from baseline to Week 24 (LOCF) between dapagliflozin 10 mg and metformin XR was less than 0.35%.|Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.1054|||2-Sided|95.0|-0.22|0.2|||||||
1708336|NCT00859898|3143100|Superiority or Other||Mean Difference (Final Values)|-0.54|Standard Error of the Mean|0.1072|<|0.0001|2-Sided|95.0|-0.75|-0.33||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant. Two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.|||
1708337|NCT00859898|3143100|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.1056|<|0.0001|2-Sided|95.0|-0.74|-0.32||Dapagliflozin 10 mg plus metformin XR treatment group had to be superior to both monotherapy treatment groups to be considered significant. Two-sided significance level at α=0.05|ANCOVA|treatment group as an effect and the baseline HbA1c value as a covariate.|||
1708338|NCT00859833|3143101|Non-Inferiority or Equivalence|Power calculation for equivalence: SD for adenosine = 0.59, SD for regadenoson = 0.92, true difference between groups = 0.19. With n=28, DOF = 46. Power for equivalence (with alpha = 0.05) = 0.98585.|Mean Difference (Final Values)|0.2|Standard Deviation|0.7||0.3617|2-Sided|95.0|-0.6041|0.2241|||t-test, 2 sided|||Null hypothesis is that myocardial perfusion reserve (MPR) is not different when measured with adenosine or regadenoson in patients across a broad range of body sizes.|
1708339|NCT00859521|3143126|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.8||||||90.0|97.2|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1708340|NCT00859521|3143127|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.4||||||90.0|96.9|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1708341|NCT00859521|3143128|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.7||||||90.0|92.4|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1708342|NCT00859430|3143139|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.4||||||90.0|95.9|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1708343|NCT00859430|3143140|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|98.6||||||90.0|96.2|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1708344|NCT00859430|3143141|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|105.0||||||90.0|98.6|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1708345|NCT00859027|3143179|Other|||||||0.01|||||||ANOVA|||Between group difference of percent change for CTX|
1708346|NCT00859027|3143179|Other|||||||0.015|||||||ANOVA|||Between group difference of percent change for NTX|
1708347|NCT00859027|3143180|Other||||||<|0.01|||||||ANOVA|||Between group difference of percent change for total hip BMD|
1708348|NCT00859027|3143180|Other||||||<|0.01|||||||ANOVA|||Between group difference of percent change for the femoral neck BMD|
1708349|NCT00859027|3143180|Other||||||<|0.04|||||||One way ANOVA|||Percent change in lumbar spine BMD from baseline|
1708350|NCT00859027|3143180|Other||||||<|0.001|||||||One way ANOVA|||Percent change in total hip BMD from baseline|
1708351|NCT00859027|3143180|Other||||||<|0.004|||||||One way ANOVA|||Percent change in femoral neck BMD from baseline|
1708352|NCT00858780|3143211|Superiority or Other||Odds Ratio (OR)|4.2||||0.044|2-Sided|95.0|1.04|16.99|||GEE Model|||Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.|
1708353|NCT00858780|3143211|Superiority or Other||Odds Ratio (OR)|1.71||||0.362|2-Sided|95.0|0.54|5.41|||GEE Model|||Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.|
1708354|NCT00858780|3143211|Superiority or Other||Odds Ratio (OR)|7.17||||0.007|2-Sided|95.0|1.72|29.82|||GEE Model|||Analysis was performed using a generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.|
1708355|NCT00858702|3143212|Superiority or Other||||||<|0.001||||||No consideration for multiplicity|Fisher Exact||||
1708356|NCT00858702|3143213|Superiority or Other|||||||0.0566||||||No consideration for multiplicity|Fisher Exact||||
1708357|NCT00858702|3143214|Superiority or Other|||||||0.0158||||||No consideration for multiplicity|Fisher Exact||||
1708377|NCT00858247|3143268|Superiority or Other|||||||0.47|||||||ANCOVA||||
1708378|NCT00858247|3143269|Superiority or Other|||||||0.4|||||||ANCOVA||||
1708379|NCT00858247|3143270|Superiority or Other|||||||0.68|||||||ANCOVA||||
1708359|NCT00858442|3143250|Non-Inferiority or Equivalence|"Applies normality test of shapiro Wilks =0.972, P> 0.687 in group without PRP and in PRP group shapiro Wilks = 0.964, P > 0.410.~The data were normally distributed, with equal variances (Test of levene: F = 3.153, P> 0.082)"|Mean Difference (Final Values)|-0.27186|Standard Error of the Mean|0.50519|>|0.593|2-Sided|95.0|-1.28561|0.74189||Applies t-test for equality of means. t = -0.538 is obtained. p> 0.593|t-test, 2 sided||||
1708360|NCT00858442|3143251|Non-Inferiority or Equivalence|"Applies normality test of shapiro Wilks = 0.953, P> 0.449 in group without PRP and in PRP group shapiro Wilks=0.946, P > 0.259.~The data were normally distributed, with equal variances (Test of levene: F = 0.1234, P> 0.99)"|Mean Difference (Final Values)|-2.452|Standard Error of the Mean|2.452|>|0.1574|2-Sided|95.0|-7.332|2.428||Applies t-test for equality of means. t = -1.016 is obtained. p> 0.1574|t-test, 1 sided||||
1708361|NCT00858364|3143261|Other||Odds Ratio (OR)|0.758||||0.003|2-Sided|95.0|0.63|0.913|||Cochran-Mantel-Haenszel|Unstratified analysis|||
1708362|NCT00858364|3143261|Other||Odds Ratio (OR)|0.741||||0.003|2-Sided|95.0|0.61|0.901|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method adjusted for the randomization stratification factors (geographic region, histology, screening hemoglobin).|An odds ratio < 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.||
1708363|NCT00858364|3143263|Other||Odds Ratio (OR)|1.173||||0.078|2-Sided|95.0|0.982|1.401|||Cochran-Mantel-Haenszel|Unstratified analysis|||
1708364|NCT00858364|3143263|Other||Odds Ratio (OR)|1.173||||0.076|2-Sided|95.0|0.983|1.401|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel method adjusted for the randomization stratification factors (geographic region, histology, screening hemoglobin).|An odds ratio < 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.||
1708365|NCT00858364|3143265|Other||Odds Ratio (OR)|0.705|||<|0.001|2-Sided|95.0|0.574|0.866|||Regression, Logistic||An odds ratio < 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|As a sensitivity analysis a logistic regression analysis was conducted, stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin).|
1708366|NCT00858364|3143265|Superiority|If non-inferiority was declared for OS and PFS, superiority would be declared for the transfusion endpoint if the p-value from a two-sided test of significance using the Cochran-Mantel-Haenszel method was less than 0.05 in favor of the darbepoetin alfa group.|Odds Ratio (OR)|0.704|||<|0.001|2-Sided|95.0|0.573|0.864|||Cochran-Mantel-Haenszel||An odds ratio < 1.0 indicates a lower event rate for darbepoetin alfa relative to placebo.|The primary analysis of the incidence of a transfusion or hemoglobin ≤ 8.0 g/dL from day 29 to EOETP was based on the Cochran-Mantel-Haenszel method to test for treatment group differences while adjusting for the randomization stratification factors (geographic region, histology, and screening hemoglobin).|
1708367|NCT00858364|3143266|Other||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.88|1.05||||||To evaluate the potential effect of cross-in (participants in the placebo group who began treatment with an erythropoiesis-stimulating agent (ESA) at any point after randomization), a sensitivity analysis was conducted that included ESA use as a time-dependent covariate in a Cox regression model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin).|
1708368|NCT00858364|3143266|Superiority|||||||0.27|||||||Log Rank|Unstratified log rank test|||
1708369|NCT00858364|3143266|Superiority|If non-inferiority was demonstrated for both OS and PFS and superiority was demonstrated for the transfusion endpoint, superiority was then tested for both OS and PFS using the Hochberg procedure to adjust for multiplicity.||||||0.31|||||||Stratified log-rank test|Stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin).|||
1708370|NCT00858364|3143266|Non-Inferiority|If non-inferiority was declared for OS, non-inferiority would be declared for PFS if the upper confidence limit for the hazard ratio was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.95|||||2-Sided|95.0|0.87|1.04|||||A hazard ratio < 1.0 indicates a lower risk of death or progression for darbepoetin alfa relative to placebo.|As a sensitivity analysis, an unstratified Cox Proportional Hazard Model with treatment group as the only covariate was conducted.|
1708371|NCT00858364|3143266|Non-Inferiority|If non-inferiority was declared for OS, non-inferiority would be declared for PFS if the upper confidence limit for the hazard ratio was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.95|||||2-Sided|95.0|0.87|1.04|||||A hazard ratio < 1.0 indicates a lower risk of death or progression for darbepoetin alfa relative to placebo.|The primary analysis of PFS used a Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.|
1708372|NCT00858364|3143267|Other||Hazard Ratio (HR)|0.93|||||2-Sided|95.0|0.84|1.02||||||To evaluate the potential effect of cross-in (participants in the placebo group who began treatment with an erythropoiesis-stimulating agent (ESA) at any point after randomization), a sensitivity analysis was conducted that included ESA use as a time-dependent covariate in a Cox regression model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin).|
1708373|NCT00858364|3143267|Superiority|||||||0.047|||||||Log Rank|Unstratified log rank test|||
1708374|NCT00858364|3143267|Superiority|If non-inferiority was demonstrated for both OS and PFS and superiority was demonstrated for the transfusion endpoint, superiority was then tested for both OS and PFS using the Hochberg procedure to adjust for multiplicity.||||||0.07|||||||Stratified log-rank test|Stratified by the randomization stratification factors (geographic region, histology, screening hemoglobin)|||
1708375|NCT00858364|3143267|Non-Inferiority|Non-inferiority was declared if the upper confidence limit for the hazard ratio (darbepoetin alfa to placebo) was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.91|||||2-Sided|95.0|0.83|1.0|||||A hazard ratio < 1.0 indicates a lower risk of death for darbepoetin alfa relative to placebo.|As a sensitivity analysis, an unstratified Cox Proportional Hazard Model with treatment group as the only covariate was conducted.|
1708376|NCT00858364|3143267|Non-Inferiority|Non-inferiority was declared if the upper confidence limit for the hazard ratio (darbepoetin alfa to placebo) was less than 1.15 using a 1-sided significance level of 0.025.|Hazard Ratio (HR)|0.92|||||2-Sided|95.0|0.83|1.01|||||A hazard ratio < 1.0 indicates a lower risk of death for darbepoetin alfa relative to placebo.|The primary analysis used the Cox Proportional Hazard Model stratified by the randomization stratification factors (geographic region, histology, and screening hemoglobin), with treatment group as the only covariate.|
1708396|NCT00858208|3143286|Superiority or Other|||||||0.1684|||||||paired t-test|||Change from baseline at Week 48|
1708397|NCT00858208|3143286|Superiority or Other|||||||0.1854|||||||paired t-test|||Change from baseline at Week 42|
1708398|NCT00858208|3143286|Superiority or Other|||||||0.0278|||||||paired t-test|||Change from baseline at Week 36|
1708399|NCT00858208|3143286|Superiority or Other|||||||0.0264|||||||paired t-test|||Change from baseline at Week 30|
1708400|NCT00858208|3143286|Superiority or Other|||||||0.016|||||||paired t-test|||Change from baseline at Week 24|
1708401|NCT00858208|3143286|Superiority or Other|||||||0.0278|||||||paired t-test|||Change from baseline at Week 18|
1708402|NCT00858208|3143286|Superiority or Other|||||||0.0133|||||||paired t-test|||Change from baseline at Week 12|
1708403|NCT00858208|3143286|Superiority or Other|||||||0.0433|||||||paired t-test|||Change from baseline at Week 6|
1708404|NCT00858208|3143287|Superiority or Other|||||||0.0072|||||||paired t-test||||
1708405|NCT00857857|3143368|Superiority or Other||Mean Difference (Final Values)|1.79|Standard Error of the Mean|0.469|||2-Sided|95.0|0.84|2.75|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2[2] = 1).||
1708406|NCT00857857|3143368|Superiority or Other||Mean Difference (Final Values)|1.28|Standard Error of the Mean|0.45|||2-Sided|95.0|0.36|2.19|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2[2] = 1).||
1708407|NCT00857857|3143368|Superiority or Other||Mean Difference (Final Values)|0.27|Standard Error of the Mean|0.495|||2-Sided|95.0|-0.73|1.28|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2[2] = 1).||
1708408|NCT00857857|3143368|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.482|||2-Sided|95.0|-1.3|0.66|||||Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2[2] = 1).||
1708409|NCT00857857|3143378|Superiority or Other||Mean Difference (Net)|0.372|Standard Error of the Mean|0.0991|||2-Sided|95.0|0.172|0.572|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 14||
1708410|NCT00857857|3143378|Superiority or Other||Mean Difference (Net)|0.229|Standard Error of the Mean|0.0858|||2-Sided|95.0|0.057|0.402|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 13||
1708411|NCT00857857|3143378|Superiority or Other||Mean Difference (Net)|0.323|Standard Error of the Mean|0.0982|||2-Sided|95.0|0.125|0.52|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 7||
1708412|NCT00857857|3143378|Superiority or Other||Mean Difference (Net)|0.462|Standard Error of the Mean|0.0991|||2-Sided|95.0|0.262|0.662|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 14||
1708413|NCT00857857|3143378|Superiority or Other||Mean Difference (Net)|0.256|Standard Error of the Mean|0.0859|||2-Sided|95.0|0.083|0.429|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 13||
1708414|NCT00857857|3143378|Superiority or Other||Mean Difference (Net)|0.297|Standard Error of the Mean|0.0976|||2-Sided|95.0|0.1|0.493|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 7||
1708415|NCT00857857|3143378|Superiority or Other||Mean Difference (Net)|0.126|Standard Error of the Mean|0.1|||2-Sided|95.0|-0.076|0.327|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 14||
1708416|NCT00857857|3143378|Superiority or Other||Mean Difference (Net)|0.081|Standard Error of the Mean|0.0856|||2-Sided|95.0|-0.092|0.253|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 13||
1708417|NCT00857857|3143378|Superiority or Other||Mean Difference (Net)|0.33|Standard Error of the Mean|0.0979|||2-Sided|95.0|0.133|0.527|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 7||
1708418|NCT00857857|3143378|Superiority or Other||Mean Difference (Net)|0.144|Standard Error of the Mean|0.1026|||2-Sided|95.0|-0.062|0.351|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 14||
1708419|NCT00857857|3143378|Superiority or Other||Mean Difference (Net)|0.185|Standard Error of the Mean|0.0884|||2-Sided|95.0|0.007|0.363|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 13||
1708420|NCT00857857|3143378|Superiority or Other||Mean Difference (Net)|0.295|Standard Error of the Mean|0.1038||||95.0|0.086|0.503|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 7||
1708421|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.514|Standard Error of the Mean|0.1017||||95.0|0.308|0.719|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 hours||
1708422|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.522|Standard Error of the Mean|0.1076||||95.0|0.304|0.739|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9.5 hours||
1708423|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.559|Standard Error of the Mean|0.1177|||2-Sided|95.0|0.322|0.797|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9 hours||
1708424|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.593|Standard Error of the Mean|0.1297||||95.0|0.331|0.854|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8.5 hours||
1708425|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.556|Standard Error of the Mean|0.1174|||2-Sided|95.0|0.319|0.793|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8 hours||
1708426|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.424|Standard Error of the Mean|0.1336|||2-Sided|95.0|0.155|0.694|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7.5 hours||
1708427|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.367|Standard Error of the Mean|0.1168|||2-Sided|95.0|0.131|0.602|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7 hour||
1708428|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.361|Standard Error of the Mean|0.104|||2-Sided|95.0|0.151|0.571|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6.5 hours||
1708429|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.367|Standard Error of the Mean|0.1111|||2-Sided|95.0|0.143|0.591|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6 hours||
1708430|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.315|Standard Error of the Mean|0.0995|||2-Sided|95.0|0.114|0.516|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5.5 hours||
1708431|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.238|Standard Error of the Mean|0.0945|||2-Sided|95.0|0.047|0.429|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 hours||
1708432|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.249|Standard Error of the Mean|0.105|||2-Sided|95.0|0.038|0.461|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4.5 hours||
1708433|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.084|Standard Error of the Mean|0.0921|||2-Sided|95.0|-0.102|0.269|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4 hour||
1708434|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.091|Standard Error of the Mean|0.0876|||2-Sided|95.0|-0.085|0.268|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3.5 hours||
1708435|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|-0.027|Standard Error of the Mean|0.0821|||2-Sided|95.0|-0.192|0.139|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3 hours||
1708436|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.058|Standard Error of the Mean|0.0818|||2-Sided|95.0|-0.107|0.223|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2.5 hours||
1708437|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.127|Standard Error of the Mean|0.0974||||95.0|-0.07|0.323|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2 hours||
1708438|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.218|Standard Error of the Mean|0.1094|||2-Sided|95.0|-0.003|0.439|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1.5 hours||
1708439|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.342|Standard Error of the Mean|0.1254|||2-Sided|95.0|0.089|0.596|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1 hour||
1708440|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.38|Standard Error of the Mean|0.1398|||2-Sided|95.0|0.098|0.663|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 45 minutes||
1708441|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.488|Standard Error of the Mean|0.1303|||2-Sided|95.0|0.225|0.751|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 30 minutes||
1708442|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.573|Standard Error of the Mean|0.1481|||2-Sided|95.0|0.274|0.872|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 20 minutes||
1708443|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.499|Standard Error of the Mean|0.1484|||2-Sided|95.0|0.199|0.8|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 15 minutes||
1708444|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.494|Standard Error of the Mean|0.1273|||2-Sided|95.0|0.237|0.751|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 minutes||
1708445|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.348|Standard Error of the Mean|0.1056|||2-Sided|95.0|0.135|0.562|||||Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 minutes||
1708446|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.44|Standard Error of the Mean|0.0984|||2-Sided|95.0|0.241|0.639|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 hours||
1708447|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.414|Standard Error of the Mean|0.1042|||2-Sided|95.0|0.203|0.625|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 9.5 hours||
1708448|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.492|Standard Error of the Mean|0.1144|||2-Sided|95.0|0.261|0.723|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 9 hours||
1708449|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.509|Standard Error of the Mean|0.1264|||2-Sided|95.0|0.254|0.765|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 8.5 hours||
1708450|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.458|Standard Error of the Mean|0.1142|||2-Sided|95.0|0.227|0.688|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 8 hours||
1708451|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.372|Standard Error of the Mean|0.1306|||2-Sided|95.0|0.108|0.636|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 7.5 hours||
1708452|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.386|Standard Error of the Mean|0.1137|||2-Sided|95.0|0.157|0.616|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 7 hour||
1708453|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.283|Standard Error of the Mean|0.1011|||2-Sided|95.0|0.079|0.488|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 6.5 hours||
1708454|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.288|Standard Error of the Mean|0.1079|||2-Sided|95.0|0.07|0.506|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 6 hours||
1708455|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.178|Standard Error of the Mean|0.0967|||2-Sided|95.0|-0.018|0.373|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5.5 hours||
1708456|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.181|Standard Error of the Mean|0.0918|||2-Sided|95.0|-0.004|0.367|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 hours||
1708457|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.204|Standard Error of the Mean|0.1025|||2-Sided|95.0|-0.004|0.411|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 4.5 hours||
1708458|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.131|Standard Error of the Mean|0.09|||2-Sided|95.0|-0.051|0.313|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 4 hours||
1708459|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.074|Standard Error of the Mean|0.0855|||2-Sided|95.0|-0.099|0.247|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 3.5 hour||
1708460|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.046|Standard Error of the Mean|0.0801|||2-Sided|95.0|-0.116|0.208|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 3 hours||
1708461|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.027|Standard Error of the Mean|0.0805|||2-Sided|95.0|-0.136|0.19|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 2.5 hours||
1708462|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.116|Standard Error of the Mean|0.0947|||2-Sided|95.0|-0.075|0.308|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 2 hours||
1708463|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.204|Standard Error of the Mean|0.1059|||2-Sided|95.0|-0.01|0.418|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 1.5 hours||
1708464|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.227|Standard Error of the Mean|0.1216|||2-Sided|95.0|-0.019|0.473|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 1 hour||
1708465|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.294|Standard Error of the Mean|0.1355|||2-Sided|95.0|0.019|0.568|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 45 minutes||
1708466|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.219|Standard Error of the Mean|0.1262|||2-Sided|95.0|-0.036|0.474|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 30 minutes||
1708467|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.233|Standard Error of the Mean|0.1436|||2-Sided|95.0|-0.057|0.524|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 20 minutes||
1708468|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.255|Standard Error of the Mean|0.1445|||2-Sided|95.0|-0.038|0.548|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 15 minutes||
1708469|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.244|Standard Error of the Mean|0.1236|||2-Sided|95.0|-0.006|0.494|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 minutes||
1708470|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.221|Standard Error of the Mean|0.1036|||2-Sided|95.0|0.011|0.431|||||Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 minutes||
1708471|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.168|Standard Error of the Mean|0.1039|||2-Sided|95.0|-0.042|0.378|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 hours||
1708472|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.187|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.035|0.41|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 9.5 hours||
1708473|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.143|Standard Error of the Mean|0.1206|||2-Sided|95.0|-0.1|0.387|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 9 hours||
1708474|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.222|Standard Error of the Mean|0.1331|||2-Sided|95.0|-0.047|0.49|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 8.5 hours||
1708475|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.168|Standard Error of the Mean|0.1203|||2-Sided|95.0|-0.075|0.411|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 8 hours||
1708476|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.146|Standard Error of the Mean|0.1373|||2-Sided|95.0|-0.131|0.423|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 7.5 hours||
1708477|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.179|Standard Error of the Mean|0.1198|||2-Sided|95.0|-0.062|0.421|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 7 hour||
1708478|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.135|Standard Error of the Mean|0.1065|||2-Sided|95.0|-0.08|0.351|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 6.5 hours||
1708479|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.178|Standard Error of the Mean|0.1138|||2-Sided|95.0|-0.052|0.407|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 6 hours||
1708480|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|-0.007|Standard Error of the Mean|0.1019|||2-Sided|95.0|-0.213|0.199|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5.5 hours||
1708481|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.13|Standard Error of the Mean|0.0968|||2-Sided|95.0|-0.065|0.326|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 hours||
1708482|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.113|Standard Error of the Mean|0.1079|||2-Sided|95.0|-0.105|0.33|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 4.5 hours||
1708483|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|-0.005|Standard Error of the Mean|0.0947|||2-Sided|95.0|-0.196|0.186|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 4 hour||
1708484|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.02|Standard Error of the Mean|0.09|||2-Sided|95.0|-0.161|0.202|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 3.5 hours||
1708485|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|-0.04|Standard Error of the Mean|0.0843|||2-Sided|95.0|-0.211|0.13|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 3 hours||
1708486|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|-0.086|Standard Error of the Mean|0.0829|||2-Sided|95.0|-0.253|0.082|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 2.5 hours||
1708487|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|-0.148|Standard Error of the Mean|0.0998|||2-Sided|95.0|-0.35|0.053|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 2 hours||
1708488|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.017|Standard Error of the Mean|0.1118|||2-Sided|95.0|-0.209|0.244|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 1.5 hours||
1708489|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|-0.016|Standard Error of the Mean|0.1283|||2-Sided|95.0|-0.276|0.243|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 1 hour||
1708490|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.065|Standard Error of the Mean|0.143|||2-Sided|95.0|-0.224|0.354|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 45 minutes||
1708491|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.058|Standard Error of the Mean|0.1332|||2-Sided|95.0|-0.212|0.327|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 30 minutes||
1708492|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.094|Standard Error of the Mean|0.1494|||2-Sided|95.0|-0.208|0.396|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 20 minutes||
1708493|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.142|Standard Error of the Mean|0.1572|||2-Sided|95.0|-0.176|0.461|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 15 minutes||
1708494|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.051|Standard Error of the Mean|0.1303|||2-Sided|95.0|-0.213|0.314|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 minutes||
1708495|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.072|Standard Error of the Mean|0.1125|||2-Sided|95.0|-0.155|0.3|||||Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 minutes||
1708496|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.085|Standard Error of the Mean|0.1024|||2-Sided|95.0|-0.122|0.292|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 hours||
1709150|NCT00852995|3144527|Superiority or Other|||||||0.0194||||||Visit 12|Cochran-Mantel-Haenszel||||
1708497|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.175|Standard Error of the Mean|0.1085|||2-Sided|95.0|-0.044|0.394|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9.5 hours||
1708498|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.154|Standard Error of the Mean|0.1189|||2-Sided|95.0|-0.086|0.394|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9 hours||
1708499|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.244|Standard Error of the Mean|0.1313|||2-Sided|95.0|-0.021|0.509|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8.5 hours||
1708500|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.247|Standard Error of the Mean|0.1187|||2-Sided|95.0|0.007|0.487|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8 hours||
1708501|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.185|Standard Error of the Mean|0.1355|||2-Sided|95.0|-0.089|0.458|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7.5 hours||
1708502|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.222|Standard Error of the Mean|0.1181|||2-Sided|95.0|-0.017|0.461|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7 hour||
1708503|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.162|Standard Error of the Mean|0.1051|||2-Sided|95.0|-0.051|0.374|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6.5 hours||
1708504|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.212|Standard Error of the Mean|0.1122|||2-Sided|95.0|-0.015|0.438|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6 hours||
1708505|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.084|Standard Error of the Mean|0.1005|||2-Sided|95.0|-0.119|0.288|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5.5 hours||
1708506|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.149|Standard Error of the Mean|0.0955|||2-Sided|95.0|-0.044|0.342|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 hours||
1708507|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.139|Standard Error of the Mean|0.1065|||2-Sided|95.0|-0.076|0.354|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4.5 hours||
1708508|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|-0.027|Standard Error of the Mean|0.0934|||2-Sided|95.0|-0.215|0.162|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4 hour||
1708509|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.042|Standard Error of the Mean|0.0888|||2-Sided|95.0|-0.138|0.221|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3.5 hours||
1708510|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.027|Standard Error of the Mean|0.0832|||2-Sided|95.0|-0.141|0.196|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3 hours||
1708511|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.045|Standard Error of the Mean|0.0826|||2-Sided|95.0|-0.121|0.212|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2.5 hours||
1708512|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.096|Standard Error of the Mean|0.0985|||2-Sided|95.0|-0.103|0.295|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2 hours||
1708513|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.045|Standard Error of the Mean|0.1102|||2-Sided|95.0|-0.178|0.268|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1.5 hours||
1708514|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.046|Standard Error of the Mean|0.1265|||2-Sided|95.0|-0.21|0.301|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1 hour||
1708515|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.016|Standard Error of the Mean|0.141|||2-Sided|95.0|-0.269|0.302|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 45 minutes||
1708516|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|-0.011|Standard Error of the Mean|0.1313|||2-Sided|95.0|-0.277|0.254|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 30 minutes||
1708517|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.069|Standard Error of the Mean|0.1471|||2-Sided|95.0|-0.229|0.366|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 20 minutes||
1708518|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.024|Standard Error of the Mean|0.1526|||2-Sided|95.0|-0.285|0.333|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 15 minutes||
1708519|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.164|Standard Error of the Mean|0.1285|||2-Sided|95.0|-0.096|0.424|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 10 minutes||
1708520|NCT00857857|3143380|Superiority or Other||Mean Difference (Net)|0.021|Standard Error of the Mean|0.1086|||2-Sided|95.0|-0.199|0.24|||||Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 minutes||
1708521|NCT00857857|3143386|Superiority or Other||Ratio of adjusted geometric mean|0.45|Standard Error of the Mean|0.107|||2-Sided|95.0|0.36|0.55|||||||
1708522|NCT00857857|3143386|Superiority or Other||Ratio of adjusted geometric mean|0.59|Standard Error of the Mean|0.112|||2-Sided|95.0|0.47|0.74|||||||
1708523|NCT00857857|3143386|Superiority or Other||Ratio of adjusted geometric mean|0.66|Standard Error of the Mean|0.107|||2-Sided|95.0|0.53|0.82|||||||
1708524|NCT00857857|3143386|Superiority or Other||Ratio of adjusted geometric mean|0.71|Standard Error of the Mean|0.116|||2-Sided|95.0|0.56|0.9|||||||
1708525|NCT00857857|3143387|Superiority or Other||Mean Difference (Net)|0.35|Standard Error of the Mean|0.0978|||2-Sided|95.0|0.153|0.548|||||Comparison of Weighted Mean FEV1 between Placebo and fluticasone propionate 0.25 mg BID.||
1708526|NCT00857857|3143387|Superiority or Other||Mean Difference (Net)|0.18|Standard Error of the Mean|0.0945|||2-Sided|95.0|-0.011|0.371|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 3 mg.||
1708527|NCT00857857|3143387|Superiority or Other||Mean Difference (Net)|0.026|Standard Error of the Mean|0.0998|||2-Sided|95.0|-0.176|0.228|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 1 mg.||
1708528|NCT00857857|3143387|Superiority or Other||Mean Difference (Net)|0.054|Standard Error of the Mean|0.0984|||2-Sided|95.0|-0.145|0.253|||||Comparison of Weighted Mean FEV1 between Placebo and GW870086 0.25 mg.||
1708529|NCT00857857|3143387|Superiority or Other||Mean Difference (Net)|0.534|Standard Error of the Mean|0.1359|||2-Sided|95.0|0.26|0.809|||||Comparison of Minimum FEV1 between Placebo and fluticasone propionate 0.25 mg BID.||
1708530|NCT00857857|3143387|Superiority or Other||Mean Difference (Net)|0.239|Standard Error of the Mean|0.1319|||2-Sided|95.0|-0.028|0.506|||||Comparison of Minimum FEV1 between Placebo and GW870086 3 mg.||
1708659|NCT00855738|3144001|Superiority or Other|||||||0.7822|||||||t-test, 2 sided|||Month 3: p-value versus baseline.|
1708531|NCT00857857|3143387|Superiority or Other||Mean Difference (Net)|0.106|Standard Error of the Mean|0.1391|||2-Sided|95.0|-0.176|0.387|||||Comparison of Minimum FEV1 between Placebo and GW870086 1 mg.||
1708532|NCT00857857|3143387|Superiority or Other||Mean Difference (Net)|-0.025|Standard Error of the Mean|0.1372|||2-Sided|95.0|-0.302|0.253|||||Comparison of Minimum FEV1 between Placebo and GW870086 0.25 mg.||
1708533|NCT00857857|3143388|Superiority or Other||Mean Difference (Net)|0.404|Standard Error of the Mean|0.0966|||2-Sided|95.0|0.209|0.599|||||||
1708534|NCT00857857|3143388|Superiority or Other||Mean Difference (Net)|0.303|Standard Error of the Mean|0.0937|||2-Sided|95.0|0.113|0.492|||||||
1708535|NCT00857857|3143388|Superiority or Other||Mean Difference (Net)|0.154|Standard Error of the Mean|0.0988|||2-Sided|95.0|-0.046|0.354|||||||
1708536|NCT00857857|3143388|Superiority or Other||Mean Difference (Net)|0.21|Standard Error of the Mean|0.0975|||2-Sided|95.0|0.013|0.407|||||||
1708537|NCT00857857|3143389|Superiority or Other||Mean Difference (Net)|0.526|Standard Error of the Mean|0.1025|||2-Sided|95.0|0.319|0.733|||||||
1708538|NCT00857857|3143389|Superiority or Other||Mean Difference (Net)|0.456|Standard Error of the Mean|0.0993|||2-Sided|95.0|0.255|0.657|||||||
1708539|NCT00857857|3143389|Superiority or Other||Mean Difference (Net)|0.265|Standard Error of the Mean|0.1048|||2-Sided|95.0|0.053|0.477|||||||
1708540|NCT00857857|3143389|Superiority or Other||Mean Difference (Net)|0.24|Standard Error of the Mean|0.1033|||2-Sided|95.0|0.031|0.449|||||||
1708541|NCT00857766|3143403|Superiority or Other||Least squares analysis|127.0|Standard Error of the Mean|35.5|<|0.001||95.0|57.0|197.0|||ANCOVA||||
1708542|NCT00857766|3143404|Superiority or Other||Least squares analysis|-0.6|Standard Error of the Mean|0.86||0.469||95.0|-2.3|1.1|||ANCOVA||||
1708543|NCT00857766|3143405|Superiority or Other||Least squares (LS) mean difference|-0.42||||0.065||95.0|-0.88|0.03|||ANCOVA||LS mean difference is calculated as FSC 250/50 minus Placebo and is adjusted for treatment, investigator, sex, smoking status, age, body mass index (BMI), waist circumference, treatment by sex interaction, age by BMI interaction, and baseline value.||
1708544|NCT00857649|3143417|Superiority or Other||Mean Difference (Final Values)|0.9|Standard Error of the Mean|0.98||0.36|2-Sided|95.0|-1.03|2.83|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.|||
1708545|NCT00857649|3143418|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|0.75||0.017|2-Sided|95.0|-3.29|-0.32|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.|||
1708546|NCT00857649|3143419|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.13||0.734|2-Sided|95.0|-0.22|0.31|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.|||
1708547|NCT00857649|3143420|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.92||0.603|2-Sided|95.0|-2.3|1.34|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.|||
1708548|NCT00857649|3143421|Superiority or Other||Mean Difference (Final Values)|1.23|Standard Error of the Mean|1.52||0.418|2-Sided|95.0|-1.75|4.21|||ANCOVA|Centre and treatment as factors and baseline score as covariate. Estimate based on Least Squares.|||
1708549|NCT00857532|3143452|Superiority or Other|||||||0.8164|||||||Spearman's Rank Order Correlation|||"P-value for Phospho-Tau correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and phospho-tau."|
1708550|NCT00857532|3143452|Superiority or Other|||||||0.58|||||||Spearman's Rank Order Correlation|||"P-value for Tau correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and tau."|
1708551|NCT00857532|3143452|Superiority or Other|||||||0.0411|||||||Spearman's Rank Order Correlation|||"P-value for Amyloid beta correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and amyloid beta."|
1708552|NCT00857532|3143453|Superiority or Other|||||||0.041|||||||Spearman's Rank Order Correlation|||"P-value for DRS-2 Total correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 total score."|
1708553|NCT00857532|3143453|Superiority or Other|||||||0.152|||||||Spearman's Rank Order Correlation|||"P-value for Memory correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 memory score."|
1708554|NCT00857532|3143453|Superiority or Other|||||||0.266|||||||Spearman's Rank Order Correlation|||"P-value for Conceptualization correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 conceptualization score."|
1708555|NCT00857532|3143453|Superiority or Other|||||||0.364|||||||Spearman's Rank Order Correlation|||"P-value for Construction correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 construction score."|
1708556|NCT00857532|3143453|Superiority or Other|||||||0.077|||||||Spearman's Rank Order Correlation|||"P-value for Initiation/Perseveration correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 initiation/perseveration score."|
1708557|NCT00857532|3143453|Superiority or Other|||||||0.021|||||||Spearman's Rank Order Correlation|||"P-value for Attention correlation coefficient. Null hypothesis is that there is no correlation between florbetapir SUVR and DRS-2 attention score."|
1708558|NCT00857415|3143484|Superiority or Other||Specificity|100.0|||||2-Sided|95.0|91.0|100.0|||||95% CI calculated by Wilson score method|Proportion of subjects who had a negative scan based on majority of 3 blinded readers|
1708559|NCT00857415|3143485|Superiority or Other||Correlation coefficient|0.78|Standard Error of the Mean|0.194|<|0.0001|2-Sided|95.0|0.58|0.89||A one-sided test (rho > 0) was performed with a significance level of alpha=0.05 to assess a significant correlation.|Spearman's Rank Correlation test||Asymptotic standard error and 95 percent CI used Fisher z-transformation.|Spearman's Rank Order Correlation of the median semiquantitative read (three readers) and the quantitative IHC measurement of cortical amyloid plaque density averaged across six brain regions.|
1708588|NCT00856583|3143839|Superiority or Other||Hazard Ratio (HR)|1.35|||<|0.0001|2-Sided|95.0|1.28|1.43|||Cox Proportional Hazard|Adjusted: disease duration, time since last suicide attempt, last antipsychotic medication (a-/typicals/both), region, year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.|
1708560|NCT00857272|3143497|Non-Inferiority or Equivalence|Fifteen percent has been established as an acceptable non-inferiority margin for evaluation of investigational bowel preparations in previous studies of FDA approved preparations (e.g. NuLytely, MoviPrep).|Difference in success rates|-2.5||||0.005|2-Sided|95.0|-11.9|6.8|||Chi-squared|||"The primary endpoint of preparation success was tested using a non-inferiority test based upon the difference D=P1-P2,~Null Hypothesis H0: P1-P2<=D0 versus Alternative Hypothesis H1: P1-P2=D1>D0,~Where P1 is the % of patients with successful preps in the HalfLytely 5mg group and P2 is the % of patients with successful preps in the HalfLytely 10mg group and D0 is the acceptable margin of equivalence equal to an absolute margin of 15%."|
1708561|NCT00856999|3143527|Equivalence|Non-parametric test equivalent to the dependent t-test|||||<|0.0004|||||||Wilcoxon (Mann-Whitney)||||
1708562|NCT00856999|3143528|Equivalence|Non-parametric test equivalent to the dependent t-test|||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1708563|NCT00856986|3143558|Superiority or Other||Estimated treatment difference, LS mean|-0.51||||||95.0|-0.7|-0.31|||||The mean change in HbA1c from randomisation to week 52 was analysed including the values before intensification as LOCF for intensified subjects||
1708564|NCT00856986|3143559|Superiority or Other||Estimated Treatment Difference, LSMean|-0.41||||||95.0|-0.6|-0.21|||||The analysis values for intensified Lira 1.8 mg subjects were kept in the treatment group and the last observation carried forward (LOCF) method was applied.|The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5%.|
1708565|NCT00856986|3143560|Superiority or Other||Estimated Treatment Difference, LSMean|-0.52||||||95.0|-0.68|-0.36||||||The estimated treatment difference between Detemir+Lira 1.8 and Lira 1.8 as well as 95% confidence interval and p-value were calculated by an ANCOVA model with treatment, country and previous OAD as fixed factors and baseline value as covariate. The p-value reflects a two-sided test for the null hypothesis of no difference between the two treatment groups with a significance level of 5% and with the power of 90%.|
1708566|NCT00856973|3143580|Superiority or Other||LS Mean Treatment Difference|2.21|Standard Error of the Mean|3.91|>|0.05|2-Sided|97.5|-10.23|14.65|||ANCOVA|||This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment group.|
1708567|NCT00856973|3143580|Superiority or Other||LS Mean Treatment Difference|7.33|Standard Error of the Mean|3.91|>|0.05|2-Sided|97.5|-5.17|19.83|||ANCOVA|Bonferroni adjustment was use for multiple comparisons|Difference calculated as Eszopiclone minus placebo|This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment grou|
1708568|NCT00856934|3143581|Superiority or Other|||||||0.05|||||||ANOVA||||
1708569|NCT00856934|3143582|Superiority or Other|||||||0.05|||||||ANOVA||||
1708570|NCT00856843|3143793|Superiority or Other|||||||0.283|||||||Chi-squared||||
1708571|NCT00856843|3143794|Superiority or Other|||||||0.013|||||||Chi-squared||||
1708572|NCT00856843|3143795|Superiority or Other|||||||0.005|||||||Chi-squared||||
1708573|NCT00856843|3143796|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1708574|NCT00856843|3143797|Superiority or Other|||||||0.004|||||||Chi-squared||||
1708575|NCT00856843|3143798|Superiority or Other|||||||0.173|||||||Chi-squared||||
1708576|NCT00856843|3143799|Superiority or Other|||||||0.763|||||||Chi-squared||||
1708577|NCT00856843|3143800|Superiority or Other|||||||0.644|||||||Chi-squared||||
1708578|NCT00856843|3143801|Superiority or Other|||||||0.02|||||||Chi-squared||||
1708579|NCT00856843|3143802|Superiority or Other|||||||0.01|||||||Chi-squared||||
1708580|NCT00856843|3143803|Superiority or Other||Difference in success rates|8.8||||0.038|2-Sided|95.0|0.9|16.8|||Chi-squared||||
1708581|NCT00856661|3143830|Superiority or Other||Odds Ratio (OR)|1.12||||0.6146|2-Sided|95.0|0.72|1.75|||Regression, Logistic|||all patients treated, who had at least one valid post-baseline assessment of the mRS. As death is a valid outcome on the mRS, patients who died within 90 days after IMP administration were included|
1708582|NCT00856661|3143831|Superiority or Other||Odds Ratio (OR)|1.22||||0.5076|2-Sided|95.0|0.68|2.18|||Regression, Logistic|||All patients treated, who had at least one valid post-baseline assessment of the mRS and with a baseline NIHSS score of 8 to 24. If no assessment was available for last observation carried forward after baseline, the mRS score was set to 5 if the patient was known to be alive, or 6, if otherwise = dead.|
1708583|NCT00856661|3143832|Superiority or Other||Odds Ratio (OR)|0.98||||0.9401|2-Sided|95.0|0.59|1.62|||Regression, Logistic||||
1708584|NCT00856661|3143833|Superiority or Other||Odds Ratio (OR)|1.45||||0.229|2-Sided|95.0|0.79|2.64|||Regression, Logistic|If no assessment was available for last observation carried forward after baseline, the mRS score was set to 5 if alive, or 6, if otherwise = death||All patients who were treated and had at least one valid post-baseline assessment of the mRS. As death is a valid outcome on the mRS, patients who died within 90 days after IMP administration were included.|
1708585|NCT00856609|3143836|Other||Slope|-1.48||||0.05|2-Sided|95.0|-3.02|0.05|||ANCOVA||||
1708586|NCT00856609|3143837|Other||Slope|-24.0||||0.01|2-Sided|95.0|-89.7|41.4|||ANCOVA||||
1708587|NCT00856609|3143838|Other||Slope|-624.8||||0.01|2-Sided|95.0|-901.8|-347.8|||ANCOVA||||
1708630|NCT00856492|3143907|Superiority or Other|||||||0.019|||||||Chi-squared||||
1708631|NCT00856349|3143926|Superiority or Other||Increase in % on target (PR Logic)|3.2|||<|0.0001|||||||McNemar|||PR Logic: Discriminator to help determine if arrhythmia is ventricular or supraventricular in dual chamber ICDs and CRT-Ds.|
1708589|NCT00856583|3143840|Superiority or Other||Hazard Ratio (HR)|1.26||||0.04|2-Sided|95.0|1.01|1.57|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last antipsychotic medication (a-/typicals/both), region, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.|
1708590|NCT00856583|3143841|Superiority or Other||Hazard Ratio (HR)|0.67||||0.044|2-Sided|95.0|0.45|0.99|||Cox Proportional Hazard|Adjusted for: age, sex, duration of schizophrenia, time since last suicide attempt, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.|
1708591|NCT00856583|3143842|Superiority or Other||Hazard Ratio (HR)|0.93||||0.65|2-Sided|95.0|0.66|1.29|||Cox Proportional Hazard|Adjusted for: age, sex, duration of schizophrenia, time since last suicide attempt, year since start of enrollment.||The basis for the statistical analysis of time to 1st occurence of this secondary outcome was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.|
1708592|NCT00856583|3143843|Superiority or Other||Hazard Ratio (HR)|1.14||||0.59|2-Sided|95.0|0.7|1.85|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.|
1708593|NCT00856583|3143844|Superiority or Other||Hazard Ratio (HR)|0.66||||0.24|2-Sided|95.0|0.33|1.32|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.|
1708594|NCT00856583|3143845|Superiority or Other||Hazard Ratio (HR)|2.13||||0.081|2-Sided|95.0|0.91|4.98|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy).||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.|
1708595|NCT00856583|3143846|Superiority or Other||Hazard Ratio (HR)|0.715||||0.26|2-Sided|95.0|0.4|1.28|||Cox Proportional Hazard|Adjusted for: age, sex, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.|
1708596|NCT00856583|3143847|Superiority or Other||Hazard Ratio (HR)|0.72||||0.34|2-Sided|95.0|0.36|1.41|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.|
1708597|NCT00856583|3143848|Superiority or Other||Hazard Ratio (HR)|1.73||||0.29|2-Sided|95.0|0.63|4.78|||Cox Proportional Hazard|Adjusted for: age and sex.||The basis for the statistical analysis of time to 1st occurence of the secondary primary outcome (one patient in the risperidone group reported more than one occurrence of this event) was the null hypothesis of hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.|
1708598|NCT00856583|3143849|Superiority or Other||Hazard Ratio (HR)|2.84||||0.0022|2-Sided|95.0|1.45|5.55|||Cox Proportional Hazard|Adjusted: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), region, year since start of enrollment||The basis for the statistical analysis of this secondary outcome was the null hypothesis of mortality hazard ratio equal to 1 for the sertindole-treated patients versus risperidone-treated patients during the WRT+30 days period.|
1708599|NCT00856583|3143850|Non-Inferiority or Equivalence|If the upper limit of the 90% CI for the estimated all-cause mortality ratio was <1.5 (pre-specified), the null hypothesis was rejected. With this limit, 7,600 PYE were required to ensure 80% power at the 5% significance level of rejecting the null hypothesis when assuming a mortality of 2 deaths per 100 PYE. As the actual mortality was only about half that anticipated, more exposure was necessary and the duration of the study increased markedly.|Hazard Ratio (HR)|0.98|||<|0.05|2-Sided|90.0|0.684|1.405|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.|The hazard ratio is calculated as sertindole (numerator) versus risperidone (denominator).|The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the ORT period.|
1708600|NCT00856583|3143850|Non-Inferiority or Equivalence|If the upper limit of the 90% confidence interval (CI) for the estimated all-cause mortality ratio was <1.5 (pre-specified), the null hypothesis was rejected. With this limit, 7,600 patient years of exposure (PYE) were required to ensure 80% power at the 5% significance level of rejecting the null hypothesis when assuming a mortality of 2 deaths per 100 PYE. As the actual mortality was only about half that anticipated, more exposure was necessary and the duration of the study increased markedly.|Hazard Ratio (HR)|1.117|||<|0.05|2-Sided|90.0|0.831|1.5|||Cox Proportional Hazard|Adjusted for: age, sex, time since last suicide attempt, last previous antipsychotic treatment (mono-/polytherapy), year since start of enrollment.|The hazard ratio is calculated as sertindole (numerator) versus risperidone (denominator).|The basis for the statistical analysis of the first primary outcome was the null hypothesis of an excess mortality in sertindole-treated patients compared to the mortality in risperidone-treated patients for the WRT+30 days period.|
1708601|NCT00856557|3143851|Superiority or Other|||||||0.39|||||||Wilcoxon (Mann-Whitney)||||
1708602|NCT00856557|3143852|Superiority or Other|||||||0.99|||||||Wilcoxon (Mann-Whitney)||||
1708658|NCT00855738|3144001|Superiority or Other|||||||0.4471|||||||t-test, 2 sided|||Month 6: p-value versus baseline.|
1708603|NCT00856557|3143853|Superiority or Other||Odds Ratio, log|0.724|Standard Error of the Mean|0.346||0.036|2-Sided||||||Mixed Models Analysis|||Considering all encounters (n=179) of all physicians for who outcomes were measured (n=111) together, are encounters in which physicians contextualized the plan of care more likely to be associated with target health outcome achievement than encounters in which physicians did not, controlling for clustering of encounters within physicians. (Generalized logistic mixed model, with random intercept for physician)|
1708604|NCT00856557|3143853|Superiority or Other|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is equal distribution of proportion of successful encounters among groups|
1708605|NCT00856544|3143898|Superiority or Other||Percent difference|6.42||||0.0038|2-Sided|95.0|2.07|10.77||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.|
1708606|NCT00856544|3143898|Superiority or Other||Percent difference|10.63|||<|0.0001|2-Sided|95.0|5.8|15.45||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.|
1708607|NCT00856544|3143899|Superiority or Other||LS mean difference|-0.26|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.35|-0.16||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.|
1708608|NCT00856544|3143899|Superiority or Other||LS mean difference|-0.35|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.44|-0.26||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.|
1708609|NCT00856544|3143900|Superiority or Other||Percent Difference|21.52|||<|0.0001|2-Sided|95.0|12.39|30.65||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal Approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.|
1708610|NCT00856544|3143900|Superiority or Other||Percent difference|27.04|||<|0.0001|2-Sided|95.0|17.94|36.13||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.|
1708611|NCT00856518|3143901|Superiority or Other|||||||0.016|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Total SWAL-QOL score|||
1708612|NCT00856518|3143901|Superiority or Other|||||||0.004|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Fear domain|||
1708613|NCT00856518|3143901|Superiority or Other|||||||0.036|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Saliva domain|||
1708614|NCT00856518|3143901|Superiority or Other|||||||0.007|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Pharyngeal domain|||
1708615|NCT00856518|3143901|Superiority or Other|||||||0.016|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Mental Health domain|||
1708616|NCT00856518|3143901|Superiority or Other|||||||0.027|||||||Wilcoxon Signed Ranks Test|EMST arm post vs. pre-treatment comparison in Burden domain|||
1708617|NCT00856518|3143901|Superiority or Other|||||||0.031|||||||Wilcoxon Signed Ranks Test|Sham arm post vs. pre-treatment comparison in Mental Health domain|||
1708618|NCT00856518|3143901|Superiority or Other|||||||0.038|||||||Wilcoxon Signed Ranks Test|Sham arm post vs. pre-treatment comparison in Burden domain|||
1708619|NCT00856518|3143901|Superiority or Other||||||>|0.05||||||Sham arm post vs. pre-treatment comparison for the total SWAL-QOL score and subscale scores except for the Burden and Mental Health domains.|Wilcoxon Signed Ranks Test||||
1708620|NCT00856518|3143901|Superiority or Other||||||>|0.022|||||||Plum Ordinal Regression test|EMST arm vs. Sham arm group comparison of treatment response in Pharyngeal domain|||
1708621|NCT00856518|3143901|Superiority or Other||||||>|0.014|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response in Burden domain|||
1708622|NCT00856518|3143901|Superiority or Other||||||>|0.05|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response for total score and all subscale scores except for Burden and Pharyngeal domains|||
1708623|NCT00856518|3143901|Superiority or Other||||||>|0.05||||||EMST arm vs. Sham arm baseline total score and subscale score comparison|Wilcoxon (Mann-Whitney)||||
1708624|NCT00856518|3143903|Superiority or Other|||||||0.0019||||||Sham arm post vs. pre-MEP comparison|t-test, 2 sided||||
1708625|NCT00856518|3143903|Superiority or Other|||||||0.00042|||||||t-test, 2 sided|EMST arm post vs. pre-MEP comparison|||
1708626|NCT00856518|3143903|Superiority or Other|||||||0.946|||||||Plum Ordinal Regression Test|EMST arm vs. Sham arm group comparison of treatment response|||
1708627|NCT00856518|3143903|Superiority or Other|||||||0.899||||||EMST arm vs. Sham arm baseline MEP value comparison|Wilcoxon (Mann-Whitney)||||
1708628|NCT00856492|3143905|Superiority or Other|||||||0.71|||||||Log Rank||||
1708629|NCT00856492|3143906|Superiority or Other|||||||0.64|||||||Log Rank||||
1708632|NCT00856349|3143926|Superiority or Other||Increase in % on target (Wavelet)|9.5|||<|0.0001|||||||McNemar|||Wavelet: Discriminator to help determine if arrhythmia is ventricular or supraventricular in single chamber ICDs.|
1708633|NCT00856349|3143926|Superiority or Other||Increase in % on target (VF NID SP)|3.5|||<|0.0116|||||||McNemar|||VF NID SP: Number of intervals to detect (NID) an arrhythmia in the VF zone for secondary prevention (SP) patients.|
1708634|NCT00856349|3143926|Superiority or Other||Increase in % on target (VF NID PP)|9.0|||<|0.0001|||||||McNemar|||VF NID PP: Number of intervals to detect (NID) an arrhythmia in the VF zone for primary prevention (PP) patients.|
1708635|NCT00856349|3143926|Superiority or Other||Increase in % on target (SVT Limit)|6.8|||<|0.0001|||||||McNemar|||SVT (Supraventricular Tachycardia) Limit: The maximum cycle length that Wavelet and PR logic will be applied to arrhythmias.|
1708636|NCT00856349|3143926|Superiority or Other||Increase in % on target (LIA)|13.6|||<|0.0001|||||||McNemar|||LIA (Lead Integrity Alert): Uploadable algorithm with the ability to increase the time between a lead fracture and potential delivery of an unnecessary shock.|
1708637|NCT00856284|3143942|Non-Inferiority or Equivalence|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.09|||||1-Sided|98.75||0.035|||||||
1708638|NCT00856284|3143942|Non-Inferiority or Equivalence|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.13|||||1-Sided|98.75||-0.006||||||The null hypotheses were tested in a fixed order at the 1-sided 0.0125 significance level at Weeks 52 and 104, independently: H01: Alogliptin 25 mg was inferior in HbA1c change from Baseline vs glipizide. H02: Alogliptin 12.5 mg was inferior vs glipizide. H03: Alogliptin 25 mg was not superior vs glipizide. H04: Alogliptin 12.5 mg was not superior vs glipizide. Each subsequent null hypothesis was tested only if all previously tested null hypotheses were rejected with respect to Weeks 52 and 104.|
1708639|NCT00856284|3143948|Non-Inferiority or Equivalence|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.09|||||1-Sided|98.75||0.003|||||||
1708640|NCT00856284|3143948|Non-Inferiority or Equivalence|Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 25 mg and glipizide in HbA1c change from Baseline was less than 0.3%. If the null hypothesis H01 was rejected, then H02 was tested to show noninferiority of alogliptin 12.5 mg versus glipizide with a margin of 0.3%. Non-inferiority was met if the upper limit of the 1-sided 98.75% CI for the difference between alogliptin 12.5 mg and glipizide in HbA1c change from Baseline was less than 0.3%.|LS Mean Difference|-0.03|||||1-Sided|98.75||0.059||||||The null hypotheses were tested in a fixed order at the 1-sided 0.0125 significance level at Weeks 52 and 104, independently: H01: Alogliptin 25 mg was inferior in HbA1c change from Baseline vs glipizide. H02: Alogliptin 12.5 mg was inferior vs glipizide. H03: Alogliptin 25 mg was not superior vs glipizide. H04: Alogliptin 12.5 mg was not superior vs glipizide. Each subsequent null hypothesis was tested only if all previously tested null hypotheses were rejected with respect to Weeks 52 and 104.|
1708641|NCT00855933|3143983|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.066||0.126|2-Sided|95.0|-0.03|0.24||a priori threshold for statistical significance = 0.05|ANCOVA||2-sided with the significance level set at 5%||
1708642|NCT00855816|3143995|Superiority or Other|||||||0.27||||||A priori threshold for significance: p<.05.|Mixed Models Analysis|Mixed model based on intent to treat sample.||Null hypothesis: there will be no differences in PTSD hyperarousal symptom changes in individuals who did receive the experimental intervention vs. those who did not .|
1708643|NCT00855738|3143996|Superiority or Other|||||||1|||||||t-test, 2 sided|||Required admission to ICU: p-value versus baseline.|
1708644|NCT00855738|3143996|Superiority or Other|||||||1|||||||t-test, 2 sided|||Requirement of informal caregiver: p-value versus baseline.|
1708645|NCT00855738|3143996|Superiority or Other|||||||0.0708|||||||t-test, 2 sided|||Cessation of usual occupation: p-value versus baseline.|
1708646|NCT00855738|3143997|Superiority or Other|||||||0.3141|||||||t-test, 2 sided|||P-value versus baseline.|
1708647|NCT00855738|3143998|Superiority or Other|||||||0.0017|||||||t-test, 2 sided|||Number of visits to the emergency room because of epilepsy: p-value versus baseline.|
1708648|NCT00855738|3143998|Superiority or Other|||||||0.0226|||||||t-test, 2 sided|||Number of visits to a specialist because of epilepsy: p-value versus baseline.|
1708649|NCT00855738|3143999|Superiority or Other|||||||0.0863|||||||McNemar|||Month 6: p-value versus baseline.|
1708650|NCT00855738|3144000|Superiority or Other|||||||0.4869|||||||t-test, 2 sided|||Sleep problems (summary 9): p-value versus baseline.|
1708651|NCT00855738|3144000|Superiority or Other|||||||0.4204|||||||t-test, 2 sided|||Sleep problems (summary 6): p-value versus baseline.|
1708652|NCT00855738|3144000|Superiority or Other|||||||0.554|||||||t-test, 2 sided|||Somnolence: p-value versus baseline.|
1708653|NCT00855738|3144000|Superiority or Other|||||||0.0625|||||||t-test, 2 sided|||Adequacy: p-value versus baseline.|
1708654|NCT00855738|3144000|Superiority or Other|||||||0.0572|||||||t-test, 2 sided|||Quantity: p-value versus baseline.|
1708655|NCT00855738|3144000|Superiority or Other|||||||0.4253|||||||t-test, 2 sided|||Awake short of breath: p-value versus baseline.|
1708656|NCT00855738|3144000|Superiority or Other|||||||1|||||||t-test, 2 sided|||Snoring: p-value verus baseline.|
1708657|NCT00855738|3144000|Superiority or Other|||||||0.2452|||||||t-test, 2 sided|||Sleep disturbance: p-value versus baseline.|
1708660|NCT00855738|3144002|Superiority or Other|||||||0.0258|||||||t-test, 2 sided|||Overall quality of life: p-value versus baseline.|
1708661|NCT00855738|3144002|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Worry about seizures (impact of seizures): p-value versus baseline.|
1708662|NCT00855738|3144002|Superiority or Other||||||<|0.4635|||||||t-test, 2 sided|||Medication effects (physical/ mental): p-value versus baseline.|
1708663|NCT00855738|3144002|Superiority or Other||||||<|0.5609|||||||t-test, 2 sided|||Mental function: p-value versus baseline.|
1708664|NCT00855738|3144002|Superiority or Other||||||<|0.6162|||||||t-test, 2 sided|||Daily activities: p-value versus baseline.|
1708665|NCT00855738|3144002|Superiority or Other||||||<|0.6299|||||||t-test, 2 sided|||Emotions (mood): p-value versus baseline.|
1708666|NCT00855738|3144002|Superiority or Other||||||<|0.8284|||||||t-test, 2 sided|||Energy: p-value versus baseline.|
1708667|NCT00855738|3144003|Superiority or Other|||||||0.0433|||||||t-test, 2 sided|||Anxiety domain: P-value vs baseline.|
1708668|NCT00855738|3144003|Superiority or Other|||||||0.1797|||||||t-test, 2 sided|||Depression domain: P-value vs baseline.|
1708669|NCT00855738|3144014|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed Rank Test||||
1708670|NCT00855738|3144015|Superiority or Other||||||<|0.0001|||||||McNemar|||Month 6: p-value versus baseline.|
1708671|NCT00855738|3144015|Superiority or Other||||||<|0.0039|||||||McNemar|||Month 3: p-value versus baseline.|
1708672|NCT00855738|3144016|Superiority or Other||||||<|0.0001|||||||McNemar|||Month 6: >=75% reduction: p-value versus baseline.|
1708673|NCT00855738|3144016|Superiority or Other||||||<|0.0001|||||||McNemar|||Month 6: >=25% reduction: p-value versus baseline.|
1708674|NCT00855738|3144016|Superiority or Other||||||<|0.0001|||||||McNemar|||Month 3 >=75% reduction: p-value versus baseline.|
1708675|NCT00855738|3144016|Superiority or Other||||||<|0.0001|||||||McNemar|||Month 3 >=25% reduction: p-value versus baseline.|
1708676|NCT00855738|3144017|Superiority or Other||||||<|0.0001|||||||McNemar|||Month 6: p-value versus baseline.|
1708677|NCT00855738|3144017|Superiority or Other||||||<|0.0001|||||||McNemar|||Month 3: p-value versus baseline.|
1708678|NCT00855595|3144033|Superiority or Other (legacy)|||||||0.0903|||||||ANCOVA||||
1708679|NCT00855582|3144036|Superiority or Other|||||||0.186||||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Ranked ANOVA||||
1708680|NCT00855582|3144036|Superiority or Other|||||||0.027||||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Ranked ANOVA||||
1708681|NCT00855582|3144037|Superiority or Other||||||<|0.001||||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.|||
1708682|NCT00855582|3144037|Superiority or Other||||||<|0.001||||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.|||
1708683|NCT00855582|3144037|Superiority or Other||||||<|0.001||||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 2.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.|||
1708684|NCT00855582|3144037|Superiority or Other||||||<|0.001||||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for Question 1.|Regression, Logistic|Logistic regression model includes terms for treatment group, region and centered-baseline IIEF EF Domain score.|||
1708685|NCT00855582|3144038|Superiority or Other||||||<|0.001||||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.|||
1708686|NCT00855582|3144038|Superiority or Other||||||<|0.006||||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.|||
1708687|NCT00855582|3144039|Superiority or Other||||||<|0.001||||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.|||
1708688|NCT00855582|3144039|Superiority or Other||||||<|0.001||||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was adjusted for baseline LUTS severity.|||
1708689|NCT00855582|3144040|Superiority or Other||Mean Difference (Final Values)|28.4|Standard Error of the Mean|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708690|NCT00855582|3144040|Superiority or Other||Mean Difference (Final Values)|13.8|Standard Error of the Mean|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708691|NCT00855582|3144041|Superiority or Other||Mean Difference (Final Values)|29.7|Standard Error of the Mean|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708692|NCT00855582|3144041|Superiority or Other||Mean Difference (Final Values)|16.9|Standard Error of the Mean|3.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708746|NCT00855465|3144099|Superiority or Other|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.|
1708693|NCT00855582|3144042|Superiority or Other||Mean Difference (Final Values)|15.8|Standard Error of the Mean|2.4|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708694|NCT00855582|3144042|Superiority or Other||Mean Difference (Final Values)|12.1|Standard Error of the Mean|2.4|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708695|NCT00855582|3144043|Superiority or Other||Mean Difference (Final Values)|0.9|Standard Error of the Mean|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708696|NCT00855582|3144043|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708697|NCT00855582|3144044|Superiority or Other||Mean Difference (Final Values)|0.9|Standard Error of the Mean|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708698|NCT00855582|3144044|Superiority or Other||Mean Difference (Final Values)|0.7|Standard Error of the Mean|0.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708699|NCT00855582|3144045|Superiority or Other||Mean Difference (Final Values)|1.9|Standard Error of the Mean|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708700|NCT00855582|3144045|Superiority or Other||Mean Difference (Final Values)|1.5|Standard Error of the Mean|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708701|NCT00855582|3144046|Superiority or Other||Mean Difference (Final Values)|1.9|Standard Error of the Mean|0.2|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708702|NCT00855582|3144046|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|0.2|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708703|NCT00855582|3144047|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.082||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708704|NCT00855582|3144047|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.384||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708705|NCT00855582|3144048|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.075||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708706|NCT00855582|3144048|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.1||0.763||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708707|NCT00855582|3144049|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.3|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708708|NCT00855582|3144049|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.3|<|0.191||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708709|NCT00855582|3144050|Superiority or Other||Mean Difference (Final Values)|-1.4|Standard Error of the Mean|0.37|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708710|NCT00855582|3144050|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.38|<|0.23||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708747|NCT00855465|3144099|Superiority or Other||Mean Difference (Final Values)|0.13||||0.0002|2-Sided|95.0|0.06|0.21||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA||||
1708711|NCT00855582|3144051|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.23||0.011||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708712|NCT00855582|3144051|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.22|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708713|NCT00855582|3144051|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.24|<|0.325||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708714|NCT00855582|3144051|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.22|<|0.215||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708715|NCT00855582|3144052|Superiority or Other||Mean Difference (Final Values)|20.9|Standard Error of the Mean|2.9|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708716|NCT00855582|3144052|Superiority or Other||Mean Difference (Final Values)|24.5|Standard Error of the Mean|3.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708717|NCT00855582|3144052|Superiority or Other||Mean Difference (Final Values)|12.0|Standard Error of the Mean|3.0|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708718|NCT00855582|3144052|Superiority or Other||Mean Difference (Final Values)|16.1|Standard Error of the Mean|3.1|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708719|NCT00855582|3144053|Superiority or Other||Mean Difference (Final Values)|4.8|Standard Error of the Mean|0.71|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708720|NCT00855582|3144053|Superiority or Other||Mean Difference (Final Values)|5.0|Standard Error of the Mean|0.59|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708721|NCT00855582|3144053|Superiority or Other||Mean Difference (Final Values)|3.1|Standard Error of the Mean|0.71|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708722|NCT00855582|3144053|Superiority or Other||Mean Difference (Final Values)|3.1|Standard Error of the Mean|0.6|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708723|NCT00855582|3144054|Superiority or Other||Mean Difference (Final Values)|-2.1|Standard Error of the Mean|0.56|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708724|NCT00855582|3144054|Superiority or Other||Mean Difference (Final Values)|-2.9|Standard Error of the Mean|0.52|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708725|NCT00855582|3144054|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.57|<|0.169||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 8. Change= Week 8 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708954|NCT00853749|3144300|Superiority or Other||Difference in proportions (percentage)|2.7|||||2-Sided|95.0|-5.0|14.2||||||Comparison between treatments for common serotype 4|
1708726|NCT00855582|3144054|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.53|<|0.121||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons. P-value is for change from Baseline at Week 4. Change= Week 4 minus Baseline|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708727|NCT00855582|3144055|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|0.5|<|0.001||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708728|NCT00855582|3144055|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.51|<|0.226||95.0||||Statistical significance was assessed at an alpha level of 0.05 with no adjustments for multiple comparisons.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708729|NCT00855582|3144056|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.26||0.156||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708730|NCT00855582|3144057|Superiority or Other||Mean Difference (Final Values)|12.5|Standard Error of the Mean|2.85|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. Based on the results of prior tests under this procedure, the statistical significance of this hypothesis was not assessed.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708731|NCT00855582|3144058|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.26|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708732|NCT00855582|3144059|Superiority or Other||Mean Difference (Final Values)|19.7|Standard Error of the Mean|2.8|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0228 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708733|NCT00855582|3144060|Superiority or Other||Mean Difference (Final Values)|3.4|Standard Error of the Mean|0.67|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708734|NCT00855582|3144061|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.59||0.181||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708735|NCT00855582|3144062|Superiority or Other||Mean Difference (Final Values)|4.7|Standard Error of the Mean|0.66|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708736|NCT00855582|3144063|Superiority or Other||Median Difference (Final Values)|-2.3|Standard Error of the Mean|0.58|<|0.001||95.0||||Statistical significance was assessed using a Dunnett-Bonferroni gatekeeping procedure for multiple hypothesis testing. The pre-specified alpha level of 0.0271 was used.|ANCOVA|ANCOVA model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction.|||
1708737|NCT00855465|3144095|Superiority or Other|||||||0.116|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.|
1708738|NCT00855465|3144095|Superiority or Other||||||<|0.0001||||||Additional analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)||||
1708739|NCT00855465|3144095|Superiority or Other||Mean Difference (Final Values)|0.47|||<|0.0001|2-Sided|95.0|0.33|0.62||Exploratory testing. Primary analysis due to result of Shapiro-Wilk test.|ANCOVA|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis as for primary efficacy parameter.|
1708740|NCT00855465|3144096|Superiority or Other|||||||0.0231|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.|
1708741|NCT00855465|3144096|Superiority or Other||Mean Difference (Final Values)|-4.96|||<|0.0001|2-Sided|95.0|-6.75|-3.16||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA||||
1708742|NCT00855465|3144096|Superiority or Other||||||<|0.0001||||||Exploratory testing. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis as for primary efficacy parameter.|
1708743|NCT00855465|3144098|Superiority or Other|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.|
1708744|NCT00855465|3144098|Superiority or Other||Mean Difference (Final Values)|-5.76||||0.0165|2-Sided|95.0|-10.45|-1.06||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA||||
1708745|NCT00855465|3144098|Superiority or Other|||||||0.122||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg Dyspnea Score, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of 105 in case of death or clinical worsening without termination visit and with the last observed value otherwise.|
1708748|NCT00855465|3144099|Superiority or Other||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO FC, TTCW, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.Nominally significant only due to hierarchical testing.|Wilcoxon (Mann-Whitney)|||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of -0.594 in case of death or clinical worsening without termination visit and with the last observed value otherwise.|
1708749|NCT00855465|3144100|Superiority or Other|||||||0.0035||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Nominally significant only due to hierarchical testing.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of 10 in case of death or clinical worsening without termination visit and with the last observed value otherwise.|
1708750|NCT00855465|3144101|Superiority or Other||Risk Difference (RD)|-3.37||||0.1724|2-Sided|95.0|-8.72|1.99||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Log Rank|Test was stratified by region.|Based on Mantel-Haenszel estimate stratified by region.|"Test for difference of occurence of Any event."|
1708751|NCT00855465|3144102|Superiority or Other|||||||0.0026||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew or died before 16 weeks were imputed with a worst value of IV in case of clinical worsening without termination visit or measurement at that termination visit and with a worst value of V in case of death and with the last observed value otherwise.|
1708752|NCT00855465|3144103|Superiority or Other|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.|
1708753|NCT00855465|3144103|Superiority or Other||Mean Difference (Final Values)|-443.99||||0.0293|2-Sided|95.0|-842.95|-45.03||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA||||
1708754|NCT00855465|3144103|Superiority or Other||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.|
1708755|NCT00855465|3144104|Superiority or Other|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.|
1708756|NCT00855465|3144104|Superiority or Other||Mean Difference (Final Values)|-246.43|||<|0.0001|2-Sided|95.0|-303.33|-189.53||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA||||
1708757|NCT00855465|3144104|Superiority or Other||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|||Missing values at week 16 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.|
1708758|NCT00855465|3144105|Superiority or Other|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.|
1708759|NCT00855465|3144105|Superiority or Other||Mean Difference (Final Values)|45.69|||<|0.0001|2-Sided|95.0|24.74|66.63||Additional analysis, due to result of Shapiro-Wilk test.|ANCOVA||||
1708760|NCT00855465|3144105|Superiority or Other||||||<|0.0001||||||Prespecified significance level for all significance tests was 5%. Primary analysis, due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region.||Missing values for participants who withdrew/died before 16 weeks were imputed with a worst value of 0m in case of death/clinical worsening without termination visit and with the last observed value otherwise. Comparison was done using analysis of covariance (ANCOVA), with baseline 6MWD as a covariate and treatment group and region as main effects. The primary statistical method was the stratified Wilcoxon test if the Shapiro-Wilk test for normality of residuals was statistically significant.|
1708761|NCT00855413|3144111|Other|Spearman correlation|spearman correlation|-0.82|||<|0.005|2-Sided|||||R = -0.82|Spearman correlation|||Correlation between time (days) to HIV RNA suppression <200 copies/mL and total z score (mean) was assessed by Spearman correlation|Correlation between time (days) to HIV RNA suppression <200 copies/mL and total z score (mean) was assessed by Spearman correlation
1708762|NCT00855413|3144113|Other|one sided ANOVA.|Mean Difference (Final Values)|4.23|Standard Deviation|0.15||0.03|2-Sided|||||The degrees of freedom (df) for the within factor (number of visits - 1) was 2, and the second df is the error df of 17.|ANOVA|||An overall summary score of neurocognitive functioning was created by averaging all tests. Best available demographically corrected normative data were utilized to create z scores and then deficit scores for impairment ratings.Change in neurocognitive functioning was analyzed using a one sided repeated measures ANOVA with neurocognitive performance as the dependent variable (total z score) and time (visit) as the independent variable. Degrees of freedom were 2,17.|
1708763|NCT00855218|3144164|Superiority or Other||Hazard Ratio (HR)|0.621||||0.076||95.0|0.321|1.2|||Log Rank|stratified one sided (alpha=0.15), adjusted on region and AFP level at baseline|||
1708764|NCT00855218|3144165|Superiority or Other||Hazard Ratio (HR)|1.586||||0.999||95.0|1.2|2.096|||Log Rank|startified one-sided (alpha=0.15), adjusted for region and AFP level at baseline|||
1708765|NCT00855218|3144166|Superiority or Other||Hazard Ratio (HR)|0.898||||0.295||95.0|0.606|1.33|||Log Rank|stratified one-sided (alpha=0.15). adjusted for region and AFP level at baseline.|||
1708766|NCT00855218|3144167|Superiority or Other||Hazard Ratio (HR)|0.797||||0.072||95.0|0.588|1.08||stratified one-sided (alpha=0.15). adjusted for region and Alfa-fetoprotein (AFP) level at baseline.|Log Rank||||
1708782|NCT00855062|3144184|Superiority or Other||Slope|-0.026|Standard Error of the Mean|0.248||0.37|2-Sided|95.0|-0.512|0.46||The p-value was not adjusted for multiple comparisons.|Regression, Linear|||"The null hypothesis was that the 24-week changes of U NP Sum between the minocycline and placebo groups are the same.~The sample size calculation showed that 100 (50 participants in each group) were required to detect the clinically meaningful difference of 0.5 with 85% power, 0.05 Type I error, two-sample and two-sided test."|
1709151|NCT00852995|3144527|Superiority or Other|||||||0.2119||||||Visit 12|Cochran-Mantel-Haenszel||||
1708767|NCT00855166|3144168|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.4428||0.3105|2-Sided|95.0|-1.32|0.43||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1708768|NCT00855166|3144169|Superiority or Other||Mean Difference (Final Values)|-0.94|Standard Error of the Mean|0.6473||0.1521|2-Sided|95.0|-2.21|0.35||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1708769|NCT00855166|3144170|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.5652||0.7013|2-Sided|95.0|-0.89|1.34||Exploratory. Model including fixed categorical effects of treatment, week, treatment-by-week interaction, gender and rescue medication as well as continuous fixed covariates of baseline measurement and baseline measurement-by-week interaction.|Mixed Models Analysis|Percent change in BMD from baseline to week 102 evaluated via longitudinal repeated measures analysis using direct likelihood.|Natural logarithms of baseline and week 102 values were used.|H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1708770|NCT00855166|3144171|Superiority or Other||Risk Difference (RD)|26.3|Standard Error of the Mean|5.309|<|0.0001|2-Sided|95.0|15.9|36.7||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|Regression, Logistic|Based on methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline value and stratum (gender).||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0|
1708771|NCT00855166|3144172|Superiority or Other||Mean Difference (Final Values)|-1.48|Standard Error of the Mean|0.3731||0.0001|2-Sided|95.0|-2.22|-0.74||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1708772|NCT00855166|3144173|Superiority or Other||Mean Difference (Final Values)|-1.52|Standard Error of the Mean|0.6162||0.0143|2-Sided|95.0|-2.74|-0.31||Significant at alpha=0.05 (2-sided). Results of key secondary endpoints are interpreted using Hochberg's method|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1708773|NCT00855166|3144174|Superiority or Other||Mean Difference (Final Values)|-2.08|Standard Error of the Mean|0.3885|<|0.0001|2-Sided|95.0|-2.84|-1.31||Significant at alpha=0.05 (2-sided)|ANCOVA|with treatment group and stratum (gender) as effects and baseline value as covariate||H0: mean(treat) minus mean(placebo) = 0 versus the alternative HA: mean(treat) minus mean(placebo) =/= 0|
1708774|NCT00855062|3144175|Superiority or Other||Mean Difference (Net)|0.19|Standard Error of the Mean|1.79||0.915|2-Sided|95.0|-3.4|3.78||The p-value is not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CES-D and MSK scores.||The null hypothesis is that the mean 24-week change of CES-D score in the minocycline group is the same as the one in the placebo group.|
1708775|NCT00855062|3144176|Superiority or Other|||||||0.766||||||The p-value is not adjusted for multiple comparisons.|Kruskal-Wallis|The chi-square score was 0.024 and the degree of freedom was 1.||The null hypothesis is that the median log10-transformed HIV RNA viral loads in the minocycline group is the same as the one in the placebo group.|
1708776|NCT00855062|3144177|Superiority or Other||Odds Ratio (OR)|1.28|Standard Error of the Mean|0.82||0.764||95.0|0.26|6.34||The p-value is not adjusted for multiple comparisons.|Regression, Logistic|"The model was not adjusted for any covariate (due to small number of being better in both groups."||"The null hypothesis is that the percentage of being better at week 24 compared to baseline in the minocycline group is the same as the one in the placebo group."|
1708777|NCT00855062|3144178|Superiority or Other||Mean Difference (Net)|7.77|Standard Error of the Mean|32.51||0.813|2-Sided|95.0|-59.07|74.6||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CD4 counts.||The null hypothesis is that the mean 48-week change in CD4 cell counts in the minocycline group is the same as the one in the placebo group.|
1708778|NCT00855062|3144179|Superiority or Other||Mean Difference (Net)|8.11|Standard Error of the Mean|17.63||0.647|2-Sided|95.0|-27.23|43.45||The p-value is not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the baseline CD4 counts.||The null hypothesis is that the mean 24-week change of CD4 cell counts in the minocycline group is the same as the one in the placebo group.|
1708779|NCT00855062|3144180|Superiority or Other|||||||0.941||||||The p-value is not adjusted for multiple comparisons.|Log Rank|||The null hypothesis is that the 48-week survival curve for the first Grade ≥ 2 toxicity and/or sign and symptoms in the minocycline group is the same as the one in the placebo group.|
1708780|NCT00855062|3144181|Superiority or Other|||||||0.661||||||The p-value is not adjusted for multiple comparisons.|Log Rank|||The null hypothesis is that the survival curve for the first Grade ≥ 2 toxicity and/or sign and symptoms in the minocycline group is the same as the one in the placebo group.|
1708781|NCT00855062|3144182|Superiority or Other||Median Difference (Net)|0.053||||0.613|2-Sided|95.0|0.043|0.062||The p-value is not adjusted for multiple comparisons.|Fisher Exact|||"The null hypothesis is that the percentage of participants feeling better in the minocycline group after 24 week treatment is the same as the one in the placebo group."|
1708783|NCT00854906|3144194|Superiority or Other||Pearson's Correlation, r|-0.26||||0.216|||||||Pearson's Correlation|||A correlation was performed between ODSI questionnaire results and each participant's FTBUT.|
1709127|NCT00852995|3144524|Superiority or Other|||||||0.26|||||||ANCOVA|Kaplan-Meier Days to Closure|||
1709152|NCT00852995|3144527|Superiority or Other|||||||0.1114||||||Visit 11|Cochran-Mantel-Haenszel||||
1708784|NCT00854906|3144194|Non-Inferiority or Equivalence|The analysis will evaluate the association between OSDI with KTBUT.|Pearson's Correlation, r|-0.34||||0.093|1-Sided||||||Pearson's correlation|||A correlation was performed between ODSI questionnaire results and each participant's KTBUT.|
1708785|NCT00854906|3144195|Non-Inferiority or Equivalence|This was a pilot study. Therefore, no formal power analyses were performed.|Mean Difference (Final Values)|0.666|Standard Deviation|3.6||0.074|2-Sided|95.0|-0.069|1.401|||t-test, 2 sided|||The paired T-test was used to compare mean KTBUT and mean FTBUT.|
1708786|NCT00854607|3144198|Superiority or Other||Mean Difference (Final Values)|-0.27||||0.213|2-Sided|90.0|-0.83|0.29||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708787|NCT00854607|3144199|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.293|2-Sided|90.0|-0.63|0.32||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708788|NCT00854607|3144200|Superiority or Other||Mean Difference (Final Values)|0.65||||0.03|2-Sided|90.0|0.09|1.22||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708789|NCT00854607|3144201|Superiority or Other||Mean Difference (Final Values)|0.39||||0.109|2-Sided|90.0|-0.13|0.91||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708790|NCT00854607|3144202|Superiority or Other||Mean Difference (Final Values)|0.17||||0.078|2-Sided|90.0|-0.03|0.38||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708791|NCT00854607|3144203|Superiority or Other||Mean Difference (Final Values)|0.15||||0.071|2-Sided|90.0|-0.02|0.32||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708792|NCT00854607|3144204|Superiority or Other||Mean Difference (Final Values)|0.41||||0.159|2-Sided|90.0|-0.27|1.08||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708793|NCT00854607|3144205|Superiority or Other||Mean Difference (Final Values)|0.21||||0.285|2-Sided|90.0|-0.41|0.83||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708794|NCT00854607|3144206|Superiority or Other||Mean Difference (Final Values)|0.47||||0.054|2-Sided|90.0|-0.01|0.96||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708795|NCT00854607|3144207|Superiority or Other||Mean Difference (Final Values)|0.19||||0.127|2-Sided|90.0|-0.09|0.46||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708796|NCT00854607|3144208|Superiority or Other||Mean Difference (Final Values)|-0.32||||0.168|2-Sided|90.0|-0.87|0.23||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708797|NCT00854607|3144209|Superiority or Other||Mean Difference (Final Values)|0.03||||0.457|2-Sided|90.0|-0.42|0.47||One-Sided P-Value|t-test, 1 sided|||Mean Difference Between Non-Responders and Responders|
1708798|NCT00854607|3144210|Superiority or Other||Mean Difference (Final Values)|0.19||||0.101|2-Sided|90.0|-0.06|0.44||One-Sided P-Value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708799|NCT00854607|3144211|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.269|2-Sided|90.0|-0.65|0.3||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708800|NCT00854607|3144212|Superiority or Other||Mean Difference (Final Values)|0.28||||0.166|2-Sided|90.0|-0.2|0.77||One-Sided P-value|t-test, 1 sided|||Mean Difference between Non-Responders and Responders|
1708801|NCT00854594|3144214|Superiority or Other|||||||0.74|||||||t-test, 2 sided|||Null hypothesis: post-intervention efficacies will be equal in the two study arms.|
1708802|NCT00854594|3144215|Superiority or Other|||||||0.26|||||||t-test, 2 sided|||Null hypothesis: pre-intervention efficacies will be equal in the two study arms.|
1708803|NCT00854360|3144227|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.3||0.187|2-Sided|95.0|-0.99|0.19||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708804|NCT00854360|3144227|Superiority or Other||LS Mean Difference|0.02|Standard Error of the Mean|0.31||0.952|2-Sided|95.0|-0.58|0.62||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708805|NCT00854360|3144227|Superiority or Other||LS Mean Difference|0.04|Standard Error of the Mean|0.31||0.903|2-Sided|95.0|-0.64|0.57||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708806|NCT00854360|3144228|Superiority or Other||LS Mean Difference|-0.29|Standard Error of the Mean|0.23||0.195|2-Sided|95.0|-0.74|0.15||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708807|NCT00854360|3144228|Superiority or Other||LS Mean Difference|-0.06|Standard Error of the Mean|0.23||0.808|2-Sided|95.0|-0.39|0.5||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708952|NCT00853749|3144300|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 9V|
1708808|NCT00854360|3144228|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.23||0.989|2-Sided|95.0|-0.45|0.46||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708809|NCT00854360|3144229|Superiority or Other||LS Mean Difference|-0.39|Standard Error of the Mean|0.23||0.083|2-Sided|95.0|-0.84|0.05||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p<0.05.|
1708810|NCT00854360|3144229|Superiority or Other||LS Mean Difference|-0.11|Standard Error of the Mean|0.21||0.605|2-Sided|95.0|-0.53|0.31||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p<0.05.|
1708811|NCT00854360|3144229|Superiority or Other||LS Mean Difference|-0.07|Standard Error of the Mean|0.23||0.747|2-Sided|95.0|-0.52|0.37||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|ANCOVA|Results obtained from ANCOVA with treatment, baseline and center in the model.||A priori threshold for statistical significance is p<0.05.|
1708812|NCT00854360|3144230|Superiority or Other||LS Mean Difference|-0.83|Standard Error of the Mean|0.26||0.001|2-Sided|95.0|-1.33|-0.33||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708813|NCT00854360|3144230|Superiority or Other||LS Mean Difference|-0.4|Standard Error of the Mean|0.25||0.114|2-Sided|95.0|-0.9|0.1||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708814|NCT00854360|3144230|Superiority or Other||LS Mean Difference|-0.45|Standard Error of the Mean|0.26||0.082|2-Sided|95.0|-0.95|0.06||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708815|NCT00854360|3144231|Superiority or Other||LS Mean Difference|-0.6|Standard Error of the Mean|0.25||0.016|2-Sided|95.0|-1.09|-0.11||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated Measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708816|NCT00854360|3144231|Superiority or Other||LS Mean Difference|-0.22|Standard Error of the Mean|0.25||0.385|2-Sided|95.0|-0.7|0.27||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708817|NCT00854360|3144231|Superiority or Other||LS Mean Difference|-0.27|Standard Error of the Mean|0.25||0.278|2-Sided|95.0|-0.77|0.22||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708818|NCT00854360|3144232|Superiority or Other||LS Mean Difference|-0.63|Standard Error of the Mean|0.25||0.013|2-Sided|95.0|-1.13|-0.13||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708819|NCT00854360|3144232|Superiority or Other||LS Mean Difference|-0.29|Standard Error of the Mean|0.25||0.257|2-Sided|95.0|-0.78|0.21||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708820|NCT00854360|3144232|Superiority or Other||LS Mean Difference|-0.29|Standard Error of the Mean|0.26||0.255|2-Sided|95.0|-0.8|0.21||A multiplicity adjustment procedure was implemented which allowed for control of the Type I error within a particular treatment comparison, as well as within a particular endpoint, however it did not control the overall Type I error.|Repeated measures ANCOVA|The repeated measures ANCOVA included covariate adjustment for baseline, day, treatment, and the treatment by day interaction.||A priori threshold for statistical significance is p<0.05.|
1708953|NCT00853749|3144300|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 6B|
1708821|NCT00854308|3144234|Superiority or Other||Hazard Ratio (HR)|0.529||||0.0418|2-Sided|95.0|0.284|0.986|||Log Rank||The hazard ratio was estimated using Cox Regression and was stratified for smoking status, ECOG performance status and histology. The hazard ratio is relative to Placebo + Erlotinib.|The null hypothesis is that there is no difference in PFS between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have prolonged PFS compared with Placebo + Erlotinib.|
1708822|NCT00854308|3144235|Superiority or Other|||||||0.3671||||||P-value was stratified for smoking status, ECOG performance status and histology.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib|
1708823|NCT00854308|3144236|Superiority or Other|||||||0.7101||||||P-value was stratified for smoking status, ECOG performance status and histology.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference in Objective Response between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have better Objective Response compared with Placebo + Erlotinib.|
1708824|NCT00854308|3144237|Superiority or Other||Hazard Ratio (HR)|1.086||||0.6873|2-Sided|95.0|0.727|1.622|||Log Rank||The hazard ratio was estimated using Cox Regression and was stratified for smoking status, Eastern Cooperative Oncology Group (ECOG) performance status and histology. The hazard ratio is relative to Placebo + Erlotinib.|The null hypothesis is that there is no difference in PFS between MetMab + Erlotinib and Placebo + Erlotinib. The alternate hypothesis is that MetMab + Erlotinib would have prolonged PFS compared with Placebo + Erlotinib.|
1708825|NCT00854100|3144246|Superiority||Least Squares Mean Difference|-0.2||||0.167|2-Sided|95.0|-0.6|0.1|||ANCOVA||||
1708826|NCT00854100|3144246|Superiority||Least Squares Mean Difference|0.0||||0.918|2-Sided|95.0|-0.3|0.3|||ANCOVA||||
1708827|NCT00854100|3144247|Superiority||Least Squares Mean Difference|-1.8||||0.227|2-Sided|95.0|-4.8|1.1|||ANCOVA||||
1708828|NCT00854100|3144247|Superiority||Least Squares Mean Difference|0.5||||0.746|2-Sided|95.0|-2.4|3.4|||ANCOVA||||
1708829|NCT00853996|3144252|Other|||||||0.002||||||No adjustment for multiple comparisons. A priori threshold for statistical significance set at 0.05|Wilcoxon (Mann-Whitney)||||
1708830|NCT00853996|3144253|Other|||||||0.002||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at <0.05|Wilcoxon (Mann-Whitney)||||
1708831|NCT00853996|3144254|Other|||||||0.001||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at <0.05|Wilcoxon (Mann-Whitney)||||
1708832|NCT00853996|3144255|Other|||||||0.067||||||No adjustment for multiple comparisons. A priori threshold for statistical significance was set at <0.05.|Wilcoxon (Mann-Whitney)||||
1708833|NCT00853996|3144256|Other||||||<|0.001||||||No adjustment for multiple comparisons since this was primary endpoint. A priori threshold for statistical significance was set at <0.05.|Wilcoxon (Mann-Whitney)||||
1708834|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|1.88||||||90.0|-1.74|5.51||||||"12 hour post-dose for standing pulse rate~Vardenafil minus Placebo"|
1708835|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|5.08||||||90.0|1.45|8.7||||||"8 hour post-dose for standing pulse rate~Vardenafil minus Placebo"|
1708836|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|6.36||||||90.0|2.73|9.98||||||"6 hour post-dose for standing pulse rate~Vardenafil minus Placebo"|
1708837|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|4.05||||||90.0|0.43|7.67||||||"4 hour post-dose for standing pulse rate~Vardenafil minus Placebo"|
1708838|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|4.72||||||90.0|1.09|8.34||||||"3 hour post-dose for standing pulse rate~Vardenafil minus Placebo"|
1708839|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|5.02||||||90.0|1.4|8.65||||||"2.5 hour post-dose for standing pulse rate~Vardenafil minus Placebo"|
1708840|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|6.83||||||90.0|3.2|10.45||||||"2 hour post-dose for standing pulse rate~Vardenafil minus Placebo"|
1708841|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|7.33||||||90.0|3.7|10.95||||||"1.5 hour post-dose for standing pulse rate~Vardenafil minus Placebo"|
1708842|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|3.45||||||90.0|0.68|6.22||||||"12 hour post-dose for supine pulse rate~Vardenafil minus Placebo"|
1708843|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|4.12||||||90.0|1.34|6.89||||||"8 hour post-dose for supine pulse rate~Vardenafil minus Placebo"|
1708844|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|5.45||||||90.0|2.68|8.22||||||"6 hour post-dose for supine pulse rate~Vardenafil minus Placebo"|
1708845|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|2.06||||||90.0|-0.71|4.83||||||"4 hour post-dose for supine pulse rate~Vardenafil minus Placebo"|
1708846|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|2.89||||||90.0|0.12|5.67||||||"3 hour post-dose for supine pulse rate~Vardenafil minus Placebo"|
1708847|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|3.64||||||90.0|0.87|6.42||||||"2.5 hour post-dose for supine pulse rate~Vardenafil minus Placebo"|
1708848|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|5.51||||||90.0|2.73|8.28||||||"2 hour post-dose for supine pulse rate~Vardenafil minus Placebo"|
1708849|NCT00853840|3144273|Superiority or Other||Mean Difference (Final Values)|6.95||||||90.0|4.18|9.72||||||"1.5 hour post-dose for supine pulse rate~Vardenafil minus Placebo"|
1708850|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-2.26||||||90.0|-4.62|0.1||||||"12 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708851|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-0.27||||||90.0|-4.13|3.59||||||"12 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708852|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-3.26||||||90.0|-5.62|-0.9||||||"8 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708853|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-3.47||||||90.0|-7.33|0.39||||||"8 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708854|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-3.43||||||90.0|-5.79|-1.06||||||"6 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708855|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-2.3||||||90.0|-6.16|1.56||||||"6 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708856|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-1.09||||||90.0|-3.46|1.27||||||"4 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708857|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-2.05||||||90.0|-5.91|1.81||||||"4 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708858|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-3.65||||||90.0|-6.01|-1.29||||||"3 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708859|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-4.27||||||90.0|-8.13|-0.41||||||"3 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708860|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-6.65||||||90.0|-9.01|-4.29||||||"2.5 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708861|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-5.8||||||90.0|-9.66|-1.94||||||"2.5 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708862|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-5.79||||||90.0|-8.15|-3.42||||||"2 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708863|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-6.91||||||90.0|-10.77|-3.05||||||"2 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708864|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-3.93||||||90.0|-6.29|-1.56||||||"1.5 hour post-dose for standing diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708865|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-4.36||||||90.0|-8.22|-0.5||||||"1.5 hour post-dose for standing systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708866|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-2.32||||||90.0|-3.94|-0.7||||||"12 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708867|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-1.94||||||90.0|-4.63|0.76||||||"12 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708868|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-2.51||||||90.0|-4.13|-0.9||||||"8 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708869|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-4.22||||||90.0|-6.91|-1.52||||||"8 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708870|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-0.85||||||90.0|-2.47|0.77||||||"6 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708871|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-2.3||||||90.0|-4.99|0.39||||||"6 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708872|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-0.88||||||90.0|-2.49|0.74||||||"4 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708873|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-2.08||||||90.0|-4.77|0.62||||||"4 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708874|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-1.76||||||90.0|-3.38|-0.15||||||"3 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708875|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-2.05||||||90.0|-4.74|0.64||||||"3 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708876|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-3.82||||||90.0|-5.44|-2.2||||||"2.5 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708877|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-4.88||||||90.0|-7.58|-2.19||||||"2.5 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708878|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-2.96||||||90.0|-4.58|-1.34||||||"2 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708879|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-4.99||||||90.0|-7.69|-2.3||||||"2 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708880|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-1.93||||||90.0|-3.55|-0.31||||||"1.5 hour post-dose for supine diastolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708881|NCT00853840|3144274|Superiority or Other||Mean Difference (Final Values)|-1.11||||||90.0|-3.8|1.59||||||"1.5 hour post-dose for supine systolic BP~Vardenafil minus Placebo~A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose."|
1708882|NCT00853749|3144294|Superiority or Other|||||||0.628|||||||Fisher Exact|||Comparison between treatments for rash|
1708883|NCT00853749|3144294|Superiority or Other|||||||0.198|||||||Fisher Exact|||Comparison between treatments for decreased sleep|
1708884|NCT00853749|3144294|Superiority or Other|||||||0.233|||||||Fisher Exact|||Comparison between treatments for increased sleep|
1708885|NCT00853749|3144294|Superiority or Other|||||||0.543|||||||Fisher Exact|||Comparison between treatments for irritability|
1708886|NCT00853749|3144294|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for decreased appetite|
1708887|NCT00853749|3144294|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for fever ≥ 38 degrees C but ≤ 39 degrees C|
1708888|NCT00853749|3144295|Superiority or Other|||||||0.314|||||||Fisher Exact|||Comparison between treatments for severe swelling|
1708889|NCT00853749|3144295|Superiority or Other|||||||0.175|||||||Fisher Exact|||Comparison between treatments for moderate swelling|
1708890|NCT00853749|3144295|Superiority or Other|||||||0.294|||||||Fisher Exact|||Comparison between treatments for mild swelling|
1708891|NCT00853749|3144295|Superiority or Other|||||||0.202|||||||Fisher Exact|||Comparison between treatments for any swelling|
1708892|NCT00853749|3144295|Superiority or Other|||||||0.225|||||||Fisher Exact|||Comparison between treatments for severe redness|
1708893|NCT00853749|3144295|Superiority or Other|||||||0.283|||||||Fisher Exact|||Comparison between treatments for moderate redness|
1708894|NCT00853749|3144295|Superiority or Other|||||||0.52|||||||Fisher Exact|||Comparison between treatments for mild redness|
1708895|NCT00853749|3144295|Superiority or Other|||||||0.135|||||||Fisher Exact|||Comparison between treatments for any redness|
1708896|NCT00853749|3144295|Superiority or Other|||||||0.38|||||||Fisher Exact|||Comparison between treatments for significant tenderness|
1708897|NCT00853749|3144295|Superiority or Other|||||||0.253|||||||Fisher Exact|||Comparison between treatments for any tenderness|
1708898|NCT00853749|3144296|Superiority or Other||Ratio of GMCs|0.86|||||2-Sided|95.0|0.6|1.23|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708899|NCT00853749|3144296|Superiority or Other||Ratio of GMCs|0.89|||||2-Sided|95.0|0.61|1.28|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 7F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708900|NCT00853749|3144296|Superiority or Other||Ratio of GMCs|0.79|||||2-Sided|95.0|0.55|1.14|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6A: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708901|NCT00853749|3144296|Superiority or Other||Ratio of GMCs|0.36|||||2-Sided|95.0|0.25|0.51|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708902|NCT00853749|3144296|Superiority or Other||Ratio of GMCs|1.14|||||2-Sided|95.0|0.76|1.72|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 3: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708903|NCT00853749|3144296|Superiority or Other||Ratio of GMCs|0.27|||||2-Sided|95.0|0.18|0.4|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708904|NCT00853749|3144296|Superiority or Other||Ratio of GMCs|0.64|||||2-Sided|95.0|0.44|0.95|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708905|NCT00853749|3144296|Superiority or Other||Ratio of GMCs|0.84|||||2-Sided|95.0|0.56|1.27|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708906|NCT00853749|3144296|Superiority or Other||Ratio of GMCs|0.57|||||2-Sided|95.0|0.38|0.85|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 18C: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708907|NCT00853749|3144296|Superiority or Other||Ratio of GMCs|0.77|||||2-Sided|95.0|0.48|1.24|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 14: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708908|NCT00853749|3144296|Superiority or Other||Ratio of GMCs|0.58|||||2-Sided|95.0|0.45|0.75|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 9V: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708909|NCT00853749|3144296|Superiority or Other||Ratio of GMCs|0.71|||||2-Sided|95.0|0.44|1.15|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708910|NCT00853749|3144296|Superiority or Other||Ratio of GMCs|0.37|||||2-Sided|95.0|0.25|0.55|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 4: Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708911|NCT00853749|3144297|Superiority or Other||Ratio of GMTs|0.8|||||2-Sided|95.0|0.54|1.2|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708912|NCT00853749|3144297|Superiority or Other||Ratio of GMTs|0.7|||||2-Sided|95.0|0.48|1.14|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 7F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708913|NCT00853749|3144297|Superiority or Other||Ratio of GMTs|1.4|||||2-Sided|95.0|0.88|2.25|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6A: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708914|NCT00853749|3144297|Superiority or Other||Ratio of GMTs|0.4|||||2-Sided|95.0|0.21|0.63|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708915|NCT00853749|3144297|Superiority or Other||Ratio of GMTs|0.8|||||2-Sided|95.0|0.56|1.18|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 3: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708916|NCT00853749|3144297|Superiority or Other||Ratio of GMTs|0.2|||||2-Sided|95.0|0.12|0.32|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708917|NCT00853749|3144297|Superiority or Other||Ratio of GMTs|0.6|||||2-Sided|95.0|0.39|0.99|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708918|NCT00853749|3144297|Superiority or Other||Ratio of GMTs|1.1|||||2-Sided|95.0|0.72|1.56|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708919|NCT00853749|3144297|Superiority or Other||Ratio of GMTs|0.6|||||2-Sided|95.0|0.33|0.98|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures(PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 18C: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708920|NCT00853749|3144297|Superiority or Other||Ratio of GMTs|1.0|||||2-Sided|95.0|0.67|1.48|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 14: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1709153|NCT00852995|3144527|Superiority or Other|||||||0.4343||||||Visit 11|Cochran-Mantel-Haenszel||||
1708921|NCT00853749|3144297|Superiority or Other||Ratio of GMTs|1.0|||||2-Sided|95.0|0.51|1.81|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 9V: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708922|NCT00853749|3144297|Superiority or Other||Ratio of GMTs|1.0|||||2-Sided|95.0|0.68|1.38|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708923|NCT00853749|3144297|Superiority or Other||Ratio of GMTs|0.6|||||2-Sided|95.0|0.35|1.12|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 4: Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708924|NCT00853749|3144298|Superiority or Other||Ratio of geometric means|0.47|||||2-Sided|95.0|0.34|0.65|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 23F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708925|NCT00853749|3144298|Superiority or Other||Ratio of geometric means|0.88|||||2-Sided|95.0|0.61|1.27|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 19F: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708926|NCT00853749|3144298|Superiority or Other||Ratio of geometric means|0.44|||||2-Sided|95.0|0.29|0.67|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 6B: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708927|NCT00853749|3144298|Superiority or Other||Ratio of geometric means|0.32|||||2-Sided|95.0|0.23|0.44|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ((PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 5: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708928|NCT00853749|3144298|Superiority or Other||Ratio of geometric means|0.3|||||2-Sided|95.0|0.22|0.42|||||CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|Serotype 1: Ratio of geometric mean avidity (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).|
1708929|NCT00853749|3144299|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 19A|
1708930|NCT00853749|3144299|Superiority or Other||Difference in proportions (percentage)|-2.0|||||2-Sided|95.0|-11.3|7.7||||||Comparison between treatments for additional serotype 7F|
1708931|NCT00853749|3144299|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 6A|
1708932|NCT00853749|3144299|Superiority or Other||Difference in proportions (percentage)|0.7|||||2-Sided|95.0|-8.5|12.2||||||Comparison between treatments for additional serotype 5|
1708933|NCT00853749|3144299|Superiority or Other||Difference in proportions (percentage)|-2.0|||||2-Sided|95.0|-11.1|7.9||||||Comparison between treatments for additional serotype 3|
1708934|NCT00853749|3144299|Superiority or Other||Difference in proportions (percentage)|2.7|||||2-Sided|95.0|-5.0|14.2||||||Comparison between treatments for additional serotype 1|
1708935|NCT00853749|3144299|Superiority or Other||Difference in proportions (percentage)|-2.0|||||2-Sided|95.0|-10.8|8.1||||||Comparison between treatments for common serotype 23F|
1708936|NCT00853749|3144299|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.5|10.0||||||Comparison between treatments for common serotype 19F|
1708937|NCT00853749|3144299|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.4|10.0||||||Comparison between treatments for common serotype 18C|
1708938|NCT00853749|3144299|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 14|
1708939|NCT00853749|3144299|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 9V|
1708940|NCT00853749|3144299|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.5|9.7||||||Comparison between treatments for common serotype 6B|
1708941|NCT00853749|3144299|Superiority or Other||Difference in proportions (percentage)|0.8|||||2-Sided|95.0|-8.6|12.7||||||Comparison between treatments for common serotype 4|
1708942|NCT00853749|3144300|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 19A|
1708943|NCT00853749|3144300|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 7F|
1708944|NCT00853749|3144300|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 6A|
1708945|NCT00853749|3144300|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 5|
1708946|NCT00853749|3144300|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.3|9.5||||||Comparison between treatments for additional serotype 3|
1708947|NCT00853749|3144300|Superiority or Other||Difference in proportions (percentage)|2.7|||||2-Sided|95.0|-5.0|14.2||||||Comparison between treatments for additional serotype 1|
1708948|NCT00853749|3144300|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 23F|
1708949|NCT00853749|3144300|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.3|9.5||||||Comparison between treatments for common serotype 19F|
1708950|NCT00853749|3144300|Superiority or Other||Difference in proportions (percentage)|2.7|||||2-Sided|95.0|-5.0|14.2||||||Comparison between treatments for common serotype 18C|
1708951|NCT00853749|3144300|Superiority or Other||Difference in proportions (percentage)|0.0|||||2-Sided|95.0|-7.8|9.5||||||Comparison between treatments for common serotype 14|
1708955|NCT00853723|3144301|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.0005||||||Thre reported p-value correspond to the PTH group compared to the PTHrp 600 group at day 15|Kruskal-Wallis|the threshold for statistical significance was p=0.05|||
1708956|NCT00853723|3144301|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05||||||The reported p-value corresponds the PTH group on Day 15 compared to the PTHrP 400 group and to the PTHrP 600 group at Day 30 and Day 60|Kruskal-Wallis|The threshold for statistical significance was p=0.05|||
1708957|NCT00853723|3144302|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.005||||||the reported p-value corresponds to change from baseline in the PTHrP 400 group at Day 15,30, 60 and 90 and the PTH group at day 90.|Kruskal-Wallis|the threshold for statistical significance was p=0.05|||
1708958|NCT00853723|3144302|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate.|||||<|0.05||||||The reported p-value corresponds to an increase compared to baseline in the PTHrP 600 group at D15 and D30|F-test, one way analysis of variance|The threshold for stastistical significance was p=0.05|||
1708959|NCT00853723|3144303|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes|||||<|0.005||||||The reported p-value corresponds to the comparison of the PTHrP 400 group at Day 15 to the PTHrP 600 and PTH groups|Kruskal-Wallis|The threshold for statistical significance was p=0.05|||
1708960|NCT00853723|3144303|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05||||||The reported p value corresponds to an increased from baseline at all time points in all Arms/groups as well as to the increase in the in the PTHrP 400 group at Day 60 and 90 compared to the PTHrP 600 and PTH groups .|F-test, one way analysis of variance|the threshold for statistical significance was p=0.05|||
1708961|NCT00853723|3144304|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.005||||||The reported p-value corresponds to the increase from baseline to D90 in the PTHrP 400 group.|F-test, one way analysis of variance|the threshold for statistical significance was p=0.05|||
1708962|NCT00853723|3144305|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.0005||||||The reported p-value correspond to the PTH group on Day 15 compared to the PTHrP 400 group and Day 15 and 30 compared to the PTHrP 600 group.|Kruskal-Wallis|The threshold for statistical significance was p=0.05|||
1708963|NCT00853723|3144305|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.005||||||The reported p-value corresponds to the PTH group on Day 30 compared to the PTHrP 400 group and Day 60 compared to the PTHRp 600 group|Kruskal-Wallis|The threshold for statistical significance was p=0.05|||
1708964|NCT00853723|3144305|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05||||||The reported p-value corresponds to PTH group on Day 60 compared to the PTHrP 400|F-test, one way analysis of variance|The threshold for statistical significance was p=0.05|||
1708965|NCT00853723|3144306|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.0005||||||The reported p-value corresponds to change from baseline at Day 15 and 30 in the PTHrP 400 group and at Day 15 in the PTHrP 600 group|F-test, one way analysis of variance|The threshold for statistical significance was p=0.05|||
1708966|NCT00853723|3144307|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||>|0.05||||||The reported p-value corresponds with percent change from baseline in all Arms/groups|Kruskal-Wallis|The threshold for statistical significance was p=0.05|||
1708967|NCT00853723|3144308|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||>|0.05||||||The reported p-value corresponds with percent change from baseline in all Arms/groups|Kruskal-Wallis|The threshold for statistical signifcance was p=0.05|||
1709154|NCT00852995|3144527|Superiority or Other|||||||0.5488||||||Visit 11|Cochran-Mantel-Haenszel||||
1708968|NCT00853723|3144309|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05||||||The reported p-value corresponds with percent change from baseline in the PTHrP 400 group|Kruskal-Wallis|The threshold for stastistical significance was p=0.05|||
1708969|NCT00853723|3144310|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05||||||The reported p-value corresponds with percent change from baseline in PTHrP 400 and 600 groups.|Kruskal-Wallis|The threshold for stastistical significance was p=0.05|||
1708970|NCT00853723|3144311|Non-Inferiority or Equivalence|An equivalence test of means for the percentage change in PINP and CTX using two one-sided tests applied to data from the parallel group design with a sample size of 31 in the PTH(1-34) group and 62 in the combined PTHrP(1-36) group achieved 80% power at 2.5% significant level for two-sided hypothesis testing (adjusted for the hypothesis testing at two key endpoints).|||||<|0.05||||||The reported p-value corresponds with percent change from baseline at Day 60 and at Day 90 for the PTH group and at day 90 for the PTHrP 400 and PTHrP 600 groups .|Kruskal-Wallis||||
1708971|NCT00853723|3144312|Non-Inferiority or Equivalence|Power calculations for this study were determined considering the expected effects of PTHrP (1-36) relative to PTH (1-34) on the primary endpoints of P1NP and CTX after 3 months of treatment relative to baseline using previously published data as weel as anticipated attrition rate. See primary outcomes.|||||<|0.05||||||The reported p-value corresponds with percent change from baseline in all Arms/groups.|Kruskal-Wallis|The threshold for stasistical significance was p=0.05|||
1708972|NCT00853723|3144313|Non-Inferiority or Equivalence|An equivalence test of means for the percentage change in PINP and CTX using two one-sided tests applied to data from the parallel group design with a sample size of 31 in the PTH(1-34) group and 62 in the combined PTHrP(1-36) group achieved 80% power at 2.5% significant level for two-sided hypothesis testing (adjusted for the hypothesis testing at two key endpoints).|||||<|0.0005||||||The reported p-value corresponds with percent change from baseline by day 15 in all three arms.|Kruskal-Wallis||||
1708973|NCT00853671|3144314|Superiority or Other||||||<|0.0001|||||||Pearson Correlation|||Pearson Correlation|
1708974|NCT00853671|3144316|Superiority or Other||||||<|0.0001|||||||Pearson Correlation||||
1708975|NCT00853658|3144320|Superiority or Other||Hazard Ratio (HR)|0.99||||0.9118|2-Sided|95.0|0.9|1.1|||Regression, Cox|||(superiority)|
1708976|NCT00853658|3144320|Non-Inferiority or Equivalence|Pre-specified Non-inferiority margin 1.104 is used.|Hazard Ratio (HR)|0.99||||0.0368|2-Sided|95.0|0.9|1.1|||Regression, Cox||||
1708977|NCT00853658|3144320|Superiority or Other||Hazard Ratio (HR)|0.96||||0.4579|2-Sided|95.0|0.85|1.07|||Regression, Cox|||(superiority) Non-Diabetic patients|
1708978|NCT00853658|3144320|Superiority or Other||Hazard Ratio (HR)|0.93||||0.1724|2-Sided|95.0|0.85|1.03|||Regression, Cox|||(superiority)|
1708979|NCT00853593|3144333|Superiority or Other||One sample mean|2.4|Standard Deviation|1.9|||1-Sided|95.0||2.7|||||||
1708980|NCT00853593|3144339|Superiority or Other||One sample proportion|0.948|||||2-Sided|95.0|0.917|0.979|||||||
1708981|NCT00853593|3144340|Superiority or Other||One sample proportion|0.959|||||2-Sided|95.0|0.93|0.987|||||||
1708982|NCT00853593|3144341|Superiority or Other||One sample proportion|0.969|||||2-Sided|95.0|0.944|0.993|||||||
1708983|NCT00853593|3144342|Superiority or Other||One sample proportion|0.927|||||2-Sided|95.0|0.887|0.967|||||||
1708984|NCT00853593|3144343|Superiority or Other||One sample mean|2.3|Standard Deviation|2.0|||1-Sided|97.5||2.7|||||||
1708985|NCT00853593|3144344|Superiority or Other||One sample mean|1.6|Standard Deviation|1.4|||1-Sided|95.0||1.8|||||||
1708986|NCT00853593|3144345|Superiority or Other||One sample proportion|0.951|||||1-Sided|95.0|0.906||||||The Model 4396 lead will be considered safe if the proportion of subjects free of Model 4396 lead-related complications at one month post-implant is greater than 80% (i.e. the one sided 95% lower confidence bound must be at least 80%).||
1708987|NCT00853580|3144346|Superiority|||||||0.73|||||||ANCOVA||||
1708988|NCT00853580|3144347|Superiority|||||||0.3|||||||ANCOVA||||
1708989|NCT00853580|3144348|Superiority|||||||0.33|||||||ANCOVA||||
1708990|NCT00853580|3144349|Superiority|||||||0.5|||||||ANCOVA||||
1708991|NCT00853580|3144350|Superiority|||||||0.2|||||||ANCOVA||||
1708992|NCT00853580|3144351|Superiority|||||||0.25|||||||ANCOVA||||
1708993|NCT00853580|3144352|Superiority|||||||0.88|||||||ANCOVA||||
1708994|NCT00853580|3144353|Superiority|||||||0.18|||||||ANCOVA||||
1708995|NCT00853580|3144354|Superiority|||||||0.37|||||||ANCOVA||||
1708996|NCT00853580|3144355|Superiority|||||||0.09|||||||ANCOVA||||
1708997|NCT00853580|3144356|Superiority|||||||0.86|||||||ANCOVA||||
1708998|NCT00853580|3144357|Superiority|||||||0.49|||||||ANCOVA||||
1708999|NCT00853580|3144358|Superiority|||||||0.37|||||||ANCOVA||||
1709000|NCT00853580|3144359|Superiority|||||||0.9|||||||ANCOVA||||
1709001|NCT00853580|3144360|Superiority|||||||0.99|||||||ANCOVA||||
1709002|NCT00853580|3144361|Superiority|||||||0.33|||||||ANCOVA||||
1709003|NCT00853580|3144362|Superiority|||||||0.04|||||||ANCOVA||||
1709004|NCT00853580|3144363|Superiority|||||||0.86|||||||ANCOVA||||
1709005|NCT00853580|3144364|Superiority|||||||0.33|||||||ANCOVA||||
1709006|NCT00853580|3144365|Superiority|||||||0.51|||||||ANCOVA||||
1709007|NCT00853385|3144412|Superiority or Other||Percent difference|5.65||||0.0091|2-Sided|95.0|1.4|9.9||Statistical testing was done at 5% significance level (2-sided).|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.|
1709128|NCT00852995|3144524|Superiority or Other||Hazard Ratio (HR)|1.19||||0.53|2-Sided|95.0|0.69|2.05||This is the P-value for the Cox Hazard Ratio|Regression, Cox||||
1709008|NCT00853385|3144412|Superiority or Other||Percent difference|5.12||||0.0151|2-Sided|95.0|0.98|9.26||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.|
1709009|NCT00853385|3144412|Superiority or Other||Percent difference|11.41|||<|0.0001|2-Sided|95.0|6.08|16.73||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.|
1709010|NCT00853385|3144413|Superiority or Other||LS mean difference|-0.25|||<|0.0001|2-Sided|95.0|-0.37|-0.13||Statistical testing was done at 5% significance level (2-sided).|Mixed Models Analysis|||LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.|
1709011|NCT00853385|3144413|Superiority or Other||LS mean difference|-0.31|||<|0.0001|2-Sided|95.0|-0.43|-0.19||Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.|
1709012|NCT00853385|3144413|Superiority or Other||LS mean difference|-0.38|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|-0.5|-0.25||A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Least squares (LS) mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.|
1709013|NCT00853385|3144414|Superiority or Other||Percent difference|18.93||||0.0007|2-Sided|95.0|7.9|29.96||Statistical testing was done at 5% significance level (2-sided).|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.|
1709014|NCT00853385|3144414|Superiority or Other||Percent difference|23.22|||<|0.0001|2-Sided|95.0|12.16|34.29||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.|
1709015|NCT00853385|3144414|Superiority or Other||Percent difference|24.24|||<|0.0001|2-Sided|95.0|13.18|35.31||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.|
1709016|NCT00853242|3144427|Superiority or Other|||||||0.3724|||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.|
1709017|NCT00853242|3144427|Superiority or Other|||||||0.7944|||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.|
1709018|NCT00853242|3144427|Superiority or Other|||||||0.2647|||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.|
1709019|NCT00853242|3144428|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.|
1709020|NCT00853242|3144428|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.|
1709021|NCT00853242|3144428|Superiority or Other||||||<|0.0249|||||||Wilcoxon Rank Sum Tests|||Analysis was performed using Wilcoxon rank sum tests.|
1709022|NCT00853151|3144470|Superiority or Other|||||||0.809||||||p-value is for LY2428757 plus TT223 2 mg versus LY2428757 plus TT223 placebo.|Mixed Models Analysis|Model included treatment, baseline therapy, strata, visit, and treatment-by-visit interaction, and continuous fixed covariate of baseline HbA1c.|||
1709023|NCT00853151|3144470|Superiority or Other|||||||0.623||||||p-value is for LY2428757 plus TT223 3 mg versus LY2428757 plus TT223 placebo.|Mixed Models Analysis|Model included treatment, baseline therapy, strata, visit, and treatment-by-visit interaction, and continuous fixed covariate of baseline HbA1c.|||
1709024|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-8.84|Standard Error of the Mean|3.77||0.026|2-Sided|95.0|-16.54|-1.14|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709025|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-2.56|Standard Error of the Mean|3.8||0.506|2-Sided|95.0|-10.31|5.2|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709026|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-5.17|Standard Error of the Mean|3.77||0.18|2-Sided|95.0|-12.87|2.52|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709027|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-3.82|Standard Error of the Mean|3.65||0.303|2-Sided|95.0|-11.27|3.63|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709028|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-5.8|Standard Error of the Mean|3.79||0.136|2-Sided|95.0|-13.55|1.94|||Longitudinal analysis|||mPAP at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709129|NCT00852995|3144524|Superiority or Other|||||||0.59|||||||ANCOVA||||
1709155|NCT00852995|3144527|Superiority or Other|||||||0.1235||||||Visit 11|Cochran-Mantel-Haenszel||||
1709029|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-9.01|Standard Error of the Mean|3.68||0.02|2-Sided|95.0|-16.52|-1.5|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709030|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-0.34|Standard Error of the Mean|3.71||0.928|2-Sided|95.0|-7.91|7.23|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709031|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-6.01|Standard Error of the Mean|3.67||0.112|2-Sided|95.0|-13.51|1.49|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709032|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-4.85|Standard Error of the Mean|3.56||0.183|2-Sided|95.0|-12.12|2.42|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709033|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-1.3|Standard Error of the Mean|3.7||0.727|2-Sided|95.0|-8.86|6.25|||Longitudinal analysis|||mPAP at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709034|NCT00853112|3144480|Superiority or Other||Mean Difference (Final Values)|-8.17|Standard Error of the Mean|3.35||0.021|2-Sided|95.0|-15.01|-1.34|||Longitudinal analysis|||mPAP at Hour 2: Longitudinal analysis was used to analyze p-value and included baseline as a covariate.|
1709035|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-1.39|Standard Error of the Mean|3.38||0.684|2-Sided|95.0|-8.28|5.51|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709036|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-3.67|Standard Error of the Mean|3.34||0.28|2-Sided|95.0|-10.5|3.15|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709037|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-1.85|Standard Error of the Mean|3.24||0.573|2-Sided|95.0|-8.46|4.77|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709038|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-6.14|Standard Error of the Mean|3.37||0.079|2-Sided|95.0|-13.02|0.75|||Longitudinal analysis|||mPAP at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709039|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-8.01|Standard Error of the Mean|3.73||0.04|2-Sided|95.0|-15.63|-0.39|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709040|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-1.39|Standard Error of the Mean|3.76||0.714|2-Sided|95.0|-9.06|6.28|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709041|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-3.67|Standard Error of the Mean|3.73||0.332|2-Sided|95.0|-11.28|3.93|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709042|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-4.47|Standard Error of the Mean|3.61||0.225|2-Sided|95.0|-11.84|2.9|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709043|NCT00853112|3144480|Superiority or Other||Adjusted Mean Difference|-4.8|Standard Error of the Mean|3.75||0.21|2-Sided|95.0|-12.47|2.86|||Longitudinal analysis|||mPAP at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709044|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.25|Standard Error of the Mean|0.29||0.392|2-Sided|95.0|-0.34|0.84|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709045|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.24|Standard Error of the Mean|0.27||0.375|2-Sided|95.0|-0.31|0.8|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709046|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.19|Standard Error of the Mean|0.27||0.495|2-Sided|95.0|-0.37|0.74|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709047|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|-0.14|Standard Error of the Mean|0.28||0.603|2-Sided|95.0|-0.71|0.42|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709048|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.07|Standard Error of the Mean|0.28||0.818|2-Sided|95.0|-0.51|0.64|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709049|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.18|Standard Error of the Mean|0.3||0.546|2-Sided|95.0|-0.43|0.79|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709050|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.41|Standard Error of the Mean|0.28||0.157|2-Sided|95.0|-0.17|1.0|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709051|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.01|Standard Error of the Mean|0.29||0.966|2-Sided|95.0|-0.58|0.6|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709052|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|-0.16|Standard Error of the Mean|0.29||0.572|2-Sided|95.0|-0.75|0.42|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709053|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.09|Standard Error of the Mean|0.29||0.771|2-Sided|95.0|-0.52|0.69|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709130|NCT00852995|3144524|Superiority or Other||Hazard Ratio (HR)|1.83||||0.0212|2-Sided|95.0|1.09|3.04|||Regression, Cox||||
1709054|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.1|Standard Error of the Mean|0.34||0.772|2-Sided|95.0|-0.6|0.8|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709055|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.43|Standard Error of the Mean|0.33||0.203|2-Sided|95.0|-0.25|1.11|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709056|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|-0.03|Standard Error of the Mean|0.33||0.928|2-Sided|95.0|-0.7|0.64|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709057|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.04|Standard Error of the Mean|0.33||0.899|2-Sided|95.0|-0.63|0.72|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709058|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.29|Standard Error of the Mean|0.34||0.396|2-Sided|95.0|-0.4|0.99|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709059|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|-0.07|Standard Error of the Mean|0.29||0.823|2-Sided|95.0|-0.67|0.53|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709060|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.44|Standard Error of the Mean|0.28||0.128|2-Sided|95.0|-0.13|1.01|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709061|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.17|Standard Error of the Mean|0.28||0.535|2-Sided|95.0|-0.39|0.74|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709062|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.0|Standard Error of the Mean|0.28||0.999|2-Sided|95.0|-0.58|0.58|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709063|NCT00853112|3144481|Superiority or Other||Adjusted Mean Difference|0.24|Standard Error of the Mean|0.29||0.412|2-Sided|95.0|-0.35|0.83|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709064|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|29.58|Standard Error of the Mean|323.01||0.928|2-Sided|95.0|-629.62|688.79|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709065|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-27.96|Standard Error of the Mean|311.11||0.929|2-Sided|95.0|-663.31|607.38|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709066|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-176.74|Standard Error of the Mean|309.11||0.572|2-Sided|95.0|-808.1|454.63|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709067|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|240.17|Standard Error of the Mean|311.63||0.447|2-Sided|95.0|-395.81|876.14|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709068|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|265.51|Standard Error of the Mean|324.88||0.42|2-Sided|95.0|-397.45|928.48|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709069|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-185.64|Standard Error of the Mean|363.77||0.613|2-Sided|95.0|-927.54|556.27|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709070|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-369.57|Standard Error of the Mean|353.25||0.304|2-Sided|95.0|-1090.86|351.72|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709071|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-28.31|Standard Error of the Mean|355.47||0.937|2-Sided|95.0|-753.46|696.83|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709072|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|98.42|Standard Error of the Mean|350.87||0.781|2-Sided|95.0|-617.15|813.99|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709073|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|47.61|Standard Error of the Mean|365.43||0.897|2-Sided|95.0|-697.56|792.79|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709074|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-134.48|Standard Error of the Mean|355.5||0.708|2-Sided|95.0|-859.74|590.77|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709075|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-494.91|Standard Error of the Mean|344.72||0.161|2-Sided|95.0|-1199.04|209.21|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709076|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|174.2|Standard Error of the Mean|342.93||0.615|2-Sided|95.0|-526.41|874.81|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709077|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-2.87|Standard Error of the Mean|342.91||0.993|2-Sided|95.0|-702.41|696.67|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709078|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-115.64|Standard Error of the Mean|357.2||0.748|2-Sided|95.0|-844.24|612.96|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709131|NCT00852995|3144524|Superiority or Other|||||||0.0211||||||P-value for Kaplan-Meier Days to Closure|ANCOVA||||
1709079|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-75.24|Standard Error of the Mean|384.2||0.846|2-Sided|95.0|-858.19|707.71|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709080|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-457.16|Standard Error of the Mean|374.26||0.231|2-Sided|95.0|-1220.86|306.53|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709081|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-287.08|Standard Error of the Mean|372.6||0.447|2-Sided|95.0|-1047.59|473.42|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709082|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-164.96|Standard Error of the Mean|370.54||0.659|2-Sided|95.0|-920.05|590.12|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709083|NCT00853112|3144482|Superiority or Other||Adjusted Mean Difference|-328.1|Standard Error of the Mean|385.78||0.401|2-Sided|95.0|-1114.11|457.92|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709084|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-256.6|Standard Error of the Mean|224.88||0.263|2-Sided|95.0|-716.26|203.06|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709085|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-289.41|Standard Error of the Mean|211.69||0.182|2-Sided|95.0|-722.17|143.35|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709086|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-341.91|Standard Error of the Mean|204.65||0.106|2-Sided|95.0|-760.45|76.64|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709087|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|77.96|Standard Error of the Mean|199.85||0.699|2-Sided|95.0|-330.7|486.63|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709088|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-145.71|Standard Error of the Mean|218.5||0.51|2-Sided|95.0|-592.24|300.83|||Longitudinal analysis|||Change at Hour 4: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709089|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-326.55|Standard Error of the Mean|272.96||0.241|2-Sided|95.0|-885.12|232.02|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709090|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-275.35|Standard Error of the Mean|258.01||0.295|2-Sided|95.0|-803.57|252.88|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709091|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-265.94|Standard Error of the Mean|259.53||0.314|2-Sided|95.0|-796.15|264.28|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709092|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|18.0|Standard Error of the Mean|245.25||0.942|2-Sided|95.0|-484.46|520.47|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709093|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-86.72|Standard Error of the Mean|263.63||0.745|2-Sided|95.0|-625.87|452.42|||Longitudinal analysis|||Change at Hour 3: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709094|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-332.25|Standard Error of the Mean|255.93||0.205|2-Sided|95.0|-856.55|192.05|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709095|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-299.6|Standard Error of the Mean|241.63||0.225|2-Sided|95.0|-794.81|195.61|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709096|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-114.06|Standard Error of the Mean|244.95||0.645|2-Sided|95.0|-614.57|386.45|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709097|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|37.9|Standard Error of the Mean|229.23||0.87|2-Sided|95.0|-432.23|508.04|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709098|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-198.06|Standard Error of the Mean|247.62||0.43|2-Sided|95.0|-705.04|308.91|||Longitudinal analysis|||Change at Hour 2: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709099|NCT00853112|3144483|Superiority or Other||Mean Difference (Final Values)|-316.86|Standard Error of the Mean|261.58||0.235|2-Sided|95.0|-850.9|217.17|||Longitudinal analysis|||Hour 1: Longitudinal analysis was used to analyze p-value and included baseline as a covariate.|
1709100|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-342.29|Standard Error of the Mean|247.07||0.176|2-Sided|95.0|-846.9|162.32|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709101|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-376.61|Standard Error of the Mean|241.06||0.129|2-Sided|95.0|-869.53|116.31|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709102|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-97.65|Standard Error of the Mean|234.55||0.68|2-Sided|95.0|-577.02|381.72|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709103|NCT00853112|3144483|Superiority or Other||Adjusted Mean Difference|-269.32|Standard Error of the Mean|252.93||0.295|2-Sided|95.0|-785.39|246.76|||Longitudinal analysis|||Change at Hour 1: The analysis was performed using longitudinal analysis model with baseline as a covariate.|
1709104|NCT00853112|3144484|Superiority or Other||Adjusted Mean Difference|-61.2|Standard Error of the Mean|321.0||0.85|2-Sided|95.0|-716.8|594.4|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709105|NCT00853112|3144484|Superiority or Other||Adjusted Mean Difference|-325.6|Standard Error of the Mean|309.58||0.301|2-Sided|95.0|-957.8|306.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709106|NCT00853112|3144484|Superiority or Other||Adjusted Mean Difference|-82.6|Standard Error of the Mean|307.67||0.79|2-Sided|95.0|-711.0|545.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709107|NCT00853112|3144484|Superiority or Other||Adjusted Mean Difference|72.2|Standard Error of the Mean|309.69||0.817|2-Sided|95.0|-560.2|704.7|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709108|NCT00853112|3144484|Superiority or Other||Adjusted Mean Difference|-0.4|Standard Error of the Mean|322.8||0.999|2-Sided|95.0|-659.7|658.8|||ANCOVA|||The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709109|NCT00853112|3144485|Superiority or Other||Adjusted Mean Difference|-62.7|Standard Error of the Mean|314.15||0.843|2-Sided|95.0|-704.3|578.9|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709110|NCT00853112|3144485|Superiority or Other||Adjusted Mean Difference|-329.4|Standard Error of the Mean|302.97||0.286|2-Sided|95.0|-948.1|289.4|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709111|NCT00853112|3144485|Superiority or Other||Adjusted Mean Difference|-262.8|Standard Error of the Mean|301.1||0.39|2-Sided|95.0|-877.8|352.1|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709112|NCT00853112|3144485|Superiority or Other||Adjusted Mean Difference|75.2|Standard Error of the Mean|303.08||0.806|2-Sided|95.0|-543.8|694.1|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709113|NCT00853112|3144485|Superiority or Other||Mean Difference (Final Values)|51.1|Standard Error of the Mean|315.91||0.873|2-Sided|95.0|-594.1|696.3|||ANCOVA|||GR over 4 hours, SVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709114|NCT00853112|3144485|Superiority or Other||Adjusted Mean Difference|-278.0|Standard Error of the Mean|200.89||0.177|2-Sided|95.0|-688.3|132.2|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709115|NCT00853112|3144485|Superiority or Other||Adjusted Mean Difference|-334.7|Standard Error of the Mean|201.74||0.107|2-Sided|95.0|-746.7|77.3|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709116|NCT00853112|3144485|Superiority or Other||Adjusted Mean Difference|-435.7|Standard Error of the Mean|195.94||0.034|2-Sided|95.0|-835.9|-35.6|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709117|NCT00853112|3144485|Superiority or Other||Adjusted Mean Difference|-34.1|Standard Error of the Mean|190.99||0.86|2-Sided|95.0|-424.1|356.0|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using ANCOVA with baseline fitted as a covariate.|
1709118|NCT00853112|3144485|Superiority or Other||Adjusted Mean Difference|-195.3|Standard Error of the Mean|207.38||0.354|2-Sided|95.0|-618.8|228.3|||ANCOVA|||GR over 4 hours, PVRI: The analysis was performed using Analysis of Covariance (ANCOVA) with baseline fitted as a covariate.|
1709119|NCT00853112|3144486|Superiority or Other||Predicted Mean Difference|-379.4|Standard Deviation|73.61||0.974|2-Sided|95.0|-520.6|-238.8|||Bayesian 4-parameter Emax model|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. Posterior distribution was calculated and was used to calculate a probability (presented as p value) that the dose gives a difference of >=240 dyne*s*m^2/cm^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.|
1709120|NCT00853112|3144486|Superiority or Other||Predicted Mean Difference|-327.9|Standard Deviation|92.41||0.81|2-Sided|95.0|-492.9|-148.0|||Bayesian 4-parameter Emax model.|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of >=240 dyne*s*m^2/cm^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.|
1709121|NCT00853112|3144486|Superiority or Other||Predicted Mean Difference|-240.2|Standard Deviation|109.28||0.485|2-Sided|95.0|-444.8|-33.8|||Bayesian 4-parameter Emax model.|||The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of >=240 dyne*s*m^2/cm^5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.|
1709122|NCT00853112|3144486|Superiority or Other||Predicted Mean Difference|-170.6|Standard Deviation|107.84||0.25|2-Sided|95.0|-409.2|-7.1|||Bayesian 4-parameter Emax model.|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of >=240 dyne.s.m2/cm5 from placebo. The predicted means and SD were the posterior means and SD from the Bayesian analysis.|
1709123|NCT00853112|3144486|Superiority or Other||Predicted Mean Difference|-115.0|Standard Deviation|98.36||0.12|2-Sided|95.0|-371.5|-1.1|||Bayesian 4-parameter Emax model|||Change over 4 hours post-dose: The Bayesian 4-parameter Emax model was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of >=240 dyne*s*m^2/cm^5 from placebo. The predicted means and SD were the posterior means and standard deviation (SD) from the Bayesian analysis.|
1709124|NCT00852995|3144524|Superiority or Other||Hazard Ratio (HR)|1.64||||0.06|2-Sided|95.0|0.97|2.77||P-value for Cox Proportional Hazard Ratio|Regression, Cox||||
1709125|NCT00852995|3144524|Superiority or Other|||||||0.1||||||P-value for Kaplan Meier Days to Closure|ANCOVA||||
1709126|NCT00852995|3144524|Superiority or Other||Hazard Ratio (HR)|1.43||||0.19|2-Sided|95.0|0.84|2.44||This is the P-value for the Cox Proportional Hazard Ratio|Regression, Cox||||
1709156|NCT00852995|3144527|Superiority or Other|||||||0.5008||||||Visit 10|Cochran-Mantel-Haenszel||||
1709157|NCT00852995|3144527|Superiority or Other|||||||0.7146||||||Visit 10|Cochran-Mantel-Haenszel||||
1709158|NCT00852995|3144527|Superiority or Other|||||||0.59||||||Visit 10|Cochran-Mantel-Haenszel||||
1709159|NCT00852995|3144527|Superiority or Other|||||||0.6964||||||Visit 10|Cochran-Mantel-Haenszel||||
1709160|NCT00852995|3144527|Superiority or Other|||||||0.0288||||||Visit 09|Cochran-Mantel-Haenszel||||
1709161|NCT00852995|3144527|Superiority or Other|||||||0.0894||||||Visit 09|Cochran-Mantel-Haenszel||||
1709162|NCT00852995|3144527|Superiority or Other|||||||0.2031||||||Visit 09|Cochran-Mantel-Haenszel||||
1709163|NCT00852995|3144527|Superiority or Other|||||||0.0054||||||Visit 09|Cochran-Mantel-Haenszel||||
1709164|NCT00852995|3144527|Superiority or Other|||||||0.0413||||||Visit 08|Cochran-Mantel-Haenszel||||
1709165|NCT00852995|3144527|Superiority or Other|||||||0.208||||||Visit 08|Cochran-Mantel-Haenszel||||
1709166|NCT00852995|3144527|Superiority or Other|||||||0.07||||||Visit 08|Cochran-Mantel-Haenszel||||
1709167|NCT00852995|3144527|Superiority or Other|||||||0.0078||||||Visit 08|Cochran-Mantel-Haenszel||||
1709168|NCT00852995|3144527|Superiority or Other|||||||0.015||||||Visit 07|Cochran-Mantel-Haenszel||||
1709169|NCT00852995|3144527|Superiority or Other|||||||0.3749||||||Visit 07|Cochran-Mantel-Haenszel||||
1709170|NCT00852995|3144527|Superiority or Other|||||||0.749||||||Visit 07|Cochran-Mantel-Haenszel||||
1709171|NCT00852995|3144527|Superiority or Other|||||||0.2439||||||Visit 07|Cochran-Mantel-Haenszel||||
1709172|NCT00852995|3144527|Superiority or Other|||||||0.4618|||||||Cochran-Mantel-Haenszel||||
1709173|NCT00852995|3144527|Superiority or Other|||||||0.9008||||||Visit 06|Cochran-Mantel-Haenszel||||
1709174|NCT00852995|3144527|Superiority or Other|||||||0.8759||||||Visit 06|Cochran-Mantel-Haenszel||||
1709175|NCT00852995|3144527|Superiority or Other|||||||0.1024||||||Visit 06|Cochran-Mantel-Haenszel||||
1709176|NCT00852995|3144527|Superiority or Other|||||||0.2994||||||Visit 05|Cochran-Mantel-Haenszel||||
1709177|NCT00852995|3144527|Superiority or Other|||||||0.9574||||||Visit 05|Cochran-Mantel-Haenszel||||
1709178|NCT00852995|3144527|Superiority or Other|||||||0.8461||||||Visit 05|Cochran-Mantel-Haenszel||||
1709179|NCT00852995|3144527|Superiority or Other|||||||0.0387||||||Visit 05|Cochran-Mantel-Haenszel||||
1709180|NCT00852995|3144527|Superiority or Other|||||||0.2884||||||Visit 04|Cochran-Mantel-Haenszel||||
1709181|NCT00852995|3144527|Superiority or Other|||||||0.8743||||||Visit 04|Cochran-Mantel-Haenszel||||
1709182|NCT00852995|3144527|Superiority or Other|||||||0.8435||||||Visit 04|Cochran-Mantel-Haenszel||||
1709183|NCT00852995|3144527|Superiority or Other|||||||0.0466||||||Visit 04|Cochran-Mantel-Haenszel||||
1709184|NCT00852995|3144527|Superiority or Other|||||||0.9832||||||Visit 03|Cochran-Mantel-Haenszel||||
1709185|NCT00852995|3144527|Superiority or Other|||||||0.6881||||||Visit 03|Cochran-Mantel-Haenszel||||
1709186|NCT00852995|3144527|Superiority or Other|||||||0.7919||||||Visit 03|Cochran-Mantel-Haenszel||||
1709187|NCT00852995|3144527|Superiority or Other|||||||0.0787||||||Visit 03|Cochran-Mantel-Haenszel||||
1709188|NCT00852995|3144527|Superiority or Other|||||||0.232||||||Visit 02|Cochran-Mantel-Haenszel||||
1709189|NCT00852995|3144527|Superiority or Other|||||||0.5721||||||Visit 02|Cochran-Mantel-Haenszel||||
1709190|NCT00852995|3144527|Superiority or Other|||||||0.3839||||||Visit 02|Cochran-Mantel-Haenszel||||
1709191|NCT00852995|3144527|Superiority or Other|||||||0.0133||||||Visit 02|Cochran-Mantel-Haenszel||||
1709192|NCT00852995|3144528|Superiority or Other|||||||0.395||||||Treatment Week 12|ANCOVA||||
1709193|NCT00852995|3144528|Superiority or Other|||||||0.127||||||Treatment Week 11|ANCOVA||||
1709194|NCT00852995|3144528|Superiority or Other|||||||0.057||||||Treatment Week 10|ANCOVA||||
1709195|NCT00852995|3144528|Superiority or Other|||||||0.089||||||Treatment Week 09|ANCOVA||||
1709196|NCT00852995|3144528|Superiority or Other|||||||0.133||||||Treatment Week 08|ANCOVA||||
1709197|NCT00852995|3144528|Superiority or Other|||||||0.026||||||Treatment Week 07|ANCOVA||||
1709198|NCT00852995|3144528|Superiority or Other|||||||0.069||||||Treatment Week 06|ANCOVA||||
1709199|NCT00852995|3144528|Superiority or Other|||||||0.079||||||Treatment Week 05|ANCOVA||||
1709200|NCT00852995|3144528|Superiority or Other|||||||0.39||||||Treatment Week 04|ANCOVA||||
1709201|NCT00852995|3144528|Superiority or Other|||||||0.161||||||Treatment Week 03|ANCOVA||||
1709202|NCT00852995|3144528|Superiority or Other|||||||0.064||||||Treatment Week 02|ANCOVA||||
1709203|NCT00852995|3144528|Superiority or Other|||||||0.037||||||Treatment Week 01|ANCOVA||||
1709204|NCT00852995|3144530|Superiority or Other|||||||0.0295|||||||t-test, 2 sided||||
1709205|NCT00852995|3144530|Superiority or Other|||||||0.1586|||||||t-test, 2 sided||||
1709206|NCT00852995|3144530|Superiority or Other|||||||0.0899|||||||t-test, 2 sided||||
1709207|NCT00852995|3144530|Superiority or Other|||||||0.00028|||||||t-test, 2 sided||||
1709208|NCT00852969|3144531|Superiority or Other||Mean Difference (Net)|-2.48||||0.29|2-Sided|95.0|-7.2|2.24|||t-test, 2 sided||||
1709209|NCT00852969|3144532|Superiority or Other||Mean Difference (Net)|-1.69||||0.71|2-Sided|95.0|-10.79|7.41|||t-test, 2 sided||||
1709210|NCT00852761|3144554|Superiority or Other|||||||0.3001||||||P value on day 15.|Chi-squared||||
1709211|NCT00852761|3144554|Superiority or Other|||||||0.4858||||||P value on day 8.|Chi-squared||||
1709212|NCT00852761|3144555|Superiority or Other|||||||0.6715||||||This is the p value for day 3.|Chi-squared||||
1709213|NCT00852761|3144555|Superiority or Other|||||||0.7242||||||This is the p value for day 8.|Chi-squared||||
1709214|NCT00852761|3144555|Superiority or Other|||||||0.6715||||||This is the p value for day 15.|Chi-squared||||
1709215|NCT00852761|3144556|Superiority or Other|||||||0.5454||||||P value at day 8.|Chi-squared||||
1709216|NCT00852761|3144556|Superiority or Other|||||||0.1634||||||P value at day 3.|Chi-squared||||
1709217|NCT00852761|3144556|Superiority or Other|||||||0.1449||||||P value at day 15.|Chi-squared||||
1709218|NCT00852761|3144558|Superiority or Other|||||||0.0135||||||This is the p value for day 15|Chi-squared||||
1709219|NCT00852761|3144558|Superiority or Other|||||||0.7242||||||This is the result for the Day 8 analysis.|Chi-squared||||
1709220|NCT00852761|3144558|Superiority or Other|||||||0.3101||||||This is the result for the Day 3 analysis.|Chi-squared||||
1709221|NCT00852761|3144560|Superiority or Other|||||||0.0332||||||Data apply to Day 15.|Chi-squared||||
1709222|NCT00852761|3144561|Superiority or Other|||||||0.006||||||This is the result for the Day 15 analysis.|Chi-squared||||
1709223|NCT00852761|3144561|Superiority or Other|||||||0.006||||||This is the result for the Day 8 analysis.|Chi-squared||||
1709224|NCT00852761|3144561|Superiority or Other|||||||0.7298||||||This is the result for the Day 3 analysis.|Chi-squared||||
1709225|NCT00852761|3144562|Superiority or Other|||||||1||||||This is the result for the Day 8 analysis.|Chi-squared||||
1709226|NCT00852761|3144562|Superiority or Other|||||||0.7298||||||This is the result for the Day 3 analysis.|Chi-squared||||
1709227|NCT00852592|3144572|Superiority or Other||||||=|0|||||||ANOVA||||
1709228|NCT00852592|3144573|Superiority or Other||||||=|0|||||||ANOVA||||
1709229|NCT00852540|3144584|Superiority or Other||Percentage of participants|84.2|||||2-Sided|95.0|72.6|95.8|||||The estimated value is the percentage of participants achieving clinical response. Confidence intervals are not adjusted for multiplicity.||
1709230|NCT00852540|3144584|Superiority or Other||percentage of participants|56.9|||||2-Sided|95.0|45.5|68.4|||||The estimated value is the percentage of participants achieving clinical response. Confidence intervals are not adjusted for multiplicity.||
1709231|NCT00852202|3144597|Superiority|||||||0.2683|||||||ANCOVA||||
1709232|NCT00852202|3144597|Superiority|||||||0.3441|||||||ANCOVA||||
1709233|NCT00852202|3144598|Superiority|||||||0.9961|||||||ANCOVA||||
1709234|NCT00852202|3144598|Superiority|||||||0.7408|||||||ANCOVA||||
1709235|NCT00851890|3144617|Superiority or Other|||||||1||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact||||
1709236|NCT00851890|3144617|Superiority or Other|||||||0.209||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact||||
1709237|NCT00851890|3144618|Superiority or Other|||||||0.031||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact||||
1709238|NCT00851890|3144618|Superiority or Other|||||||0.473||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact||||
1709239|NCT00851890|3144618|Superiority or Other|||||||0.209||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact||||
1709240|NCT00851890|3144619|Superiority or Other|||||||0.138||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact||||
1709241|NCT00851890|3144619|Superiority or Other|||||||0.026||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact||||
1709242|NCT00851890|3144619|Superiority or Other|||||||0.026||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|Fisher Exact||||
1709243|NCT00851890|3144620|Superiority or Other|||||||0.014||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.|
1709244|NCT00851890|3144620|Superiority or Other|||||||0.005||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.|
1709245|NCT00851890|3144620|Superiority or Other|||||||0.01||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Final Visit time point.|
1709246|NCT00851890|3144620|Superiority or Other|||||||0.054||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.|
1709247|NCT00851890|3144620|Superiority or Other|||||||0.02||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.|
1709248|NCT00851890|3144620|Superiority or Other|||||||0.018||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||The statistical analysis represents the Day 28 time point.|
1709249|NCT00851890|3144627|Superiority or Other|||||||0.009||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided >95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.|
1709250|NCT00851890|3144627|Superiority or Other|||||||0.003||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided >95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.|
1709265|NCT00851721|3144704|Superiority or Other|||||||0.003|||||||Two-sample, two-sided t-test|||Spontaneous Non-Joint Bleeds|
1709266|NCT00851721|3144704|Superiority or Other|||||||0.0013|||||||Two-sample, two-sided t-test|||Spontaneous Joint Bleeds|
1709251|NCT00851890|3144627|Superiority or Other|||||||0.008||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided >95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.|
1709252|NCT00851890|3144628|Superiority or Other|||||||0.14||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided >95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.|
1709253|NCT00851890|3144628|Superiority or Other|||||||0.071||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided >95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.|
1709254|NCT00851890|3144628|Superiority or Other|||||||0.012||||||No adjustments were made for multiple comparisons and the pre-specified, two-sided significance level was 0.05.|ANCOVA|The treatment group was the factor and log10 baseline HCV RNA level was the covariate.||Eight participants per ABT-333 group and 12 participants in the placebo group provided >95% power to detect a 1.4 log10 difference with a common standard deviation of 0.7 log10 using a two-sided, non-paired t-test with a significance level of 0.05.|
1709255|NCT00851799|3144658|Superiority or Other||Difference in Change (%)|-0.21||||0.53|2-Sided|97.5|-0.98|0.55||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Regression, Linear||The difference in change in relative FMD (Cohort B - Cohort A and C); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.|The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and a RAL-containing regimen. However, in the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.|
1709256|NCT00851799|3144658|Superiority or Other||Difference in Change|0.24||||0.53|2-Sided|97.5|-0.63|1.11||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Regression, Linear||The difference in change in relative FMD (Cohort A: ATV/RTV+FTC/TDF - Cohort C: DRV/RTV+FTC/TDF); estimated by linear regression that adjusted for study entry BA diameter and screening HIV-1 RNA level and Framingham risk score stratification factors.|The study was designed to compare change from study entry to week 24 in brachial artery (BA) flow mediated dilation (FMD) between a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) and a RAL-containing regimen. However, in the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.|
1709257|NCT00851799|3144659|Superiority or Other||Difference in annual rate of change|1.9||||0.31|2-Sided|97.5|-2.4|6.2||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort C: DRV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.|
1709258|NCT00851799|3144659|Superiority or Other||Difference in annual rate of change|-2.8||||0.15|2-Sided|97.5|-7.0|1.5||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort B: RAL + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.|
1709259|NCT00851799|3144659|Superiority or Other||Difference in annual rate of change|-4.7||||0.013|2-Sided|97.5|-8.9|-0.4||Inference was assessed against a type I error of 2.5% to account for multiple comparisons.|Mixed Models Analysis||The difference in the rate of CIMT change (Cohort A: ATV/RTV + FTC/TDF - Cohort C: DRV/RTV + FTC/TDF) was estimated by mixed effects linear regression model that adjusted for screening HIV-1 RNA level and Framingham risk score stratification factors.|The primary hypothesis was that rate of change of CIMT would be faster over 144 weeks in participants initiating a RTV-boosted protease inhibitor-containing regimen (the pooled ATV/RTV and DRV/RTV groups) compared with a RAL-containing regimen. However, In the event of a significant difference between ATV/RTV and DRV/RTV groups, the study was designed to make all pairwise treatment group comparisons.|
1709260|NCT00851786|3144661|Superiority or Other||Mean Difference (Final Values)|0.57|Standard Error of the Mean|0.06|<|0.001|2-Sided|95.0|0.45|0.69||The p-value was adjusted for baseline gpELISA titer, measurement time (week 6 vs. week 12), CD4 stratum and age.|Linear mixed effect model|Natural log transformed gpELISA titers after one or two doses of vaccine was modeled.||Null hypothesis: VZV antibody titer measured by gpELISA, after 1 or 2 doses of ZOSTAVAX/placebo is the same between ZOSTAVAX arm and the placebo arm|
1709261|NCT00851721|3144695|Superiority or Other|||||||0.0067|||||||Mann-Whitney tests (Wilcoxon-Rank Sum)||||
1709262|NCT00851721|3144702|Superiority or Other|||||||0.0271|||||||Two-sample, two-sided t-test||||
1709263|NCT00851721|3144704|Superiority or Other|||||||0.9322|||||||Two-sample, two-sided t-test|||Traumatic Non-Joint Bleeds|
1709264|NCT00851721|3144704|Superiority or Other|||||||0.0254|||||||Two-sample, two-sided t-test|||Traumatic Joint Bleeds|
1709267|NCT00851721|3144704|Superiority or Other|||||||0.0227|||||||Two-sample, two-sided t-test|||Non-Joint Bleeds|
1709268|NCT00851721|3144704|Superiority or Other|||||||0.0006|||||||Two-sample, two-sided t-test|||Joint Bleeds|
1709269|NCT00851721|3144704|Superiority or Other|||||||0.0199|||||||Two-sample, two-sided t-test|||Traumatic Bleeds|
1709270|NCT00851721|3144704|Superiority or Other|||||||0.0008|||||||Two-sample, two-sided t-test|||Spontaneous Bleeds|
1709271|NCT00851721|3144706|Superiority or Other|||||||0.0003|||||||Two-sample, two-sided t-test|||H0: μ(on-demand) = μ(prophylaxis) Versus H1: μ(on-demand) ≠ μ(prophylaxis) (Where H0 implies no difference in mean bleeding episode rate between prophylaxis and on-demand treatment arms and H1 implies otherwise. This test was performed at a significance level of 5%, two-sided, two sample)|
1709272|NCT00850993|3144742|Other|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-2.63|||=|0|2-Sided|95.0|-4.97|-0.3|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.|
1709273|NCT00850993|3144742|Other|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-1.34|||=|0|2-Sided|95.0|-3.24|0.56|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.|
1709274|NCT00850993|3144742|Other|Pairwise comparison for Change from Baseline at 48 hours (Row 3) for Stannsoporfin treatment group versus placebo|LS Mean Difference|-1.81|||=|0|2-Sided|95.0|-3.71|0.09|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Analysis of covariance (ANCOVA) is conducted for TSB including treatment and gestational age as fixed effects and baseline TSB as a covariate. Least-squares means (LS means) and standard errors (SEM) are estimated for each treatment group and placebo. LS mean difference, 95% Confidence Interval, and p-value are estimated based on LS mean difference between each stannsoporfin group and placebo.|
1709275|NCT00850993|3144743|Other||LS Mean Difference|-14.93|||=|0|2-Sided|95.0|-30.31|0.44|||ANCOVA||||
1709276|NCT00850993|3144743|Other||LS Mean Difference|-10.02|||=|0|2-Sided|95.0|-22.61|2.58|||ANCOVA||||
1709277|NCT00850993|3144743|Other|Pairwise comparison for each Stannsoporfin treatment group versus placebo.|LS Mean Difference|-13.45|||=|0|2-Sided|95.0|-26.27|-0.62|||ANCOVA|||Last Observation Carry Forward (LOCF) is used to impute missing post-baseline TSB. Least-squares means are from an ANCOVA model for adjusted TSB with treatment and gestational age as fixed effects and baseline adjusted TSB as a covariate. TSB is calculated as [(TSB - Phototherapy(PT) threshold)/ PT threshold ] X 100%.|
1709278|NCT00850759|3144748|Superiority or Other||Slope|0.04|||<|0.05|2-Sided|95.0|||||ANOVA||||
1709279|NCT00850564|3144768|Superiority or Other|||||||0.61|||||||Paired t-test|||Paired t-test comparing insulin stimulated glucose uptake (M) between baseline and 2 week visits.|
1709280|NCT00850564|3144769|Superiority or Other||||||<|0.005|||||||Paired t-test|||Paired t-test comparing baseline and 2 week mean overnight growth hormone|
1709281|NCT00850174|3144801|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.8||||||90.0|97.5|102.15|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.||
1709282|NCT00850174|3144802|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.94||||||90.0|97.75|102.18|||||Results presented for informational purposes only, metabolite not subjected to bioequivalence criteria.||
1709283|NCT00850174|3144803|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|100.77||||||90.0|97.03|104.65|||||Results presented for informational purposes only; metabolite not subjected to Bioequivalence criteria.||
1709284|NCT00850174|3144804|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.19||||||90.0|98.78|105.71|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709285|NCT00850174|3144805|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.54||||||90.0|99.19|106.01|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709286|NCT00850174|3144806|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.48||||||90.0|88.98|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709287|NCT00850135|3144808|Superiority or Other|||||||0.035||||||p-Value for the correlation between AUC-110 and birth weight|correlation||||
1709288|NCT00850070|3144813|Superiority or Other||Mean Difference (Final Values)|-2.0|Standard Error of the Mean|0.9||0.05|||||||Mixed Models Analysis||||
1709289|NCT00850070|3144819|Superiority or Other||Mean Difference (Final Values)|2.0|||<|0.06|||||||Chi-squared||||
1709290|NCT00850070|3144820|Superiority or Other||Mean Difference (Final Values)|2.0|||<|0.35|||||||Chi-squared||Estimated value comparison was active treatment minus placebo.|Chi-square analyses were used to assess CGI-I scores. There were no transformations.|
1709291|NCT00849901|3144839|Superiority or Other|||||||0.999|||||||Mixed Models Analysis||||
1709292|NCT00849862|3144878|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|99.6||||||90.0|96.2|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709796|NCT00842153|3146178|Superiority or Other||||||<|0.1269||||||P-value for Week 1|Fisher Exact||||
1709293|NCT00849862|3144879|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|100.0||||||90.0|96.3|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709294|NCT00849862|3144880|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.2||||||90.0|85.0|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709295|NCT00849797|3144882|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.08||||||90.0|98.91|101.27|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.||
1709296|NCT00849797|3144883|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.29||||||90.0|98.96|101.64|||||Results presented for informational purposes only, metabolite not subjected to bioequivalence criteria.||
1709297|NCT00849797|3144884|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.5||||||90.0|95.66|100.48|||||Results presented for informational purposes only; metabolite not subjected to bioequivalence criteria.||
1709298|NCT00849797|3144885|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.74||||||90.0|96.71|100.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709299|NCT00849797|3144886|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.6||||||90.0|96.59|100.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709300|NCT00849797|3144887|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|90.86||||||90.0|85.47|96.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709301|NCT00849693|3144900|Superiority or Other|||||||0.193|||||||Mixed Models Analysis||||
1709302|NCT00849485|3144908|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|98.1|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709303|NCT00849485|3144909|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|99.9||||||90.0|97.6|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709304|NCT00849485|3144910|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Geometric Test/Ref Ratio x 100|98.0||||||90.0|94.5|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709305|NCT00849472|3144921|Superiority or Other||Percentage of participants|17.98|||||2-Sided|95.0|10.64|27.55|||||The estimated value (EV) represents the percentage of participants with pCR. Participants with missing data were excluded from the denominator (n=89; 4 participants with missing data) for the calculation of the EV.||
1709306|NCT00849108|3144951|Superiority or Other||SPECT specificity|0.836||||0.317|2-Sided|95.0|0.751|0.921||p-value for comparison of SPECT specificity for same reader|McNemar||no standard deviation for SPECT specificity||
1709307|NCT00849108|3144951|Superiority or Other||PET specificity|0.877||||0.317|2-Sided|95.0|0.801|0.952||p-value for comparison of PET specificity for same reader|McNemar||no standard deviation for PET specficity||
1709308|NCT00849108|3144953|Superiority or Other||Sensitivity|0.596||||0.02|2-Sided|95.0|0.463|0.73||p-value for sensitivity comparison for SPECT MPI for the same reader|McNemar||No standard deviation can be calculated for SPECT sensitivity||
1709309|NCT00849108|3144953|Superiority or Other||sensitivity|0.769||||0.02|2-Sided|95.0|0.655|0.884||P-Value for sensitivity comparison of PET MPI for the same reader|McNemar|two-sided McNemar test with 1 degree of freedom.|No standard deviation can be calculated for PET sensitivity||
1709310|NCT00849056|3144962|Superiority or Other||Mean Difference (Net)|-0.75|||<|0.0001|2-Sided|95.0|-0.95|-0.56|||ANCOVA||||
1709311|NCT00849017|3144976|Superiority or Other||Mean Difference (Net)|-1.04|||<|0.0001|2-Sided|95.0|-1.31|-0.77|||ANCOVA||||
1709312|NCT00849017|3144976|Superiority or Other||Mean Difference (Net)|-0.84|||<|0.0001|2-Sided|95.0|-1.11|-0.58|||ANCOVA||||
1709313|NCT00848965|3144983|Superiority or Other||Mean Difference (Final Values)|-1.9|Standard Error of the Mean|0.351|||2-Sided|95.0|-2.6|-1.19|||||Treatment difference is presented as the difference in the adjusted means for treatment versus placebo.||
1709314|NCT00848965|3144983|Superiority or Other||Mean Difference (Final Values)|-1.72|Standard Error of the Mean|0.305|||2-Sided|95.0|-2.33|-1.11|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.||
1709315|NCT00848965|3144983|Superiority or Other||Mean Difference (Final Values)|-1.55|Standard Error of the Mean|0.309|||2-Sided|95.0|-2.16|-0.93|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.||
1709316|NCT00848965|3144983|Superiority or Other||Mean Difference (Final Values)|-1.38|Standard Error of the Mean|0.35|||2-Sided|95.0|-2.08|-0.68|||||Treatment difference (FP minus placebo) is presented as the difference in the adjusted means for treatment versus placebo.||
1709334|NCT00848354|3145052|Superiority or Other||||||<|0.0021||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.|
1709797|NCT00841906|3146189|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1709317|NCT00848536|3145018|Non-Inferiority or Equivalence|The non-inferiority margin was 1.5 mmHg.|Median Difference (Final Values)|-0.2|Standard Error of the Mean|0.35|||2-Sided|95.0|-0.9|0.5|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was < 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.|
1709318|NCT00848536|3145019|Non-Inferiority or Equivalence|The non-inferiority margin was 1.5 mmHg.|Median Difference (Final Values)|-0.1|Standard Error of the Mean|0.35|||2-Sided|95.0|-0.8|0.6|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was < 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.|
1709319|NCT00848536|3145020|Non-Inferiority or Equivalence|The non-inferiority margin was 1.5 mmHg.|Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.35|||2-Sided|95.0|-0.9|0.5|||||Treatment group differences were calculated as the mean IOP in the Travoprost APS group minus the mean IOP in the Travatan group. Non-inferiority was demonstrated if the upper 95% CL of the between treatment difference in mean IOP was < 1.5 mmHg.|A hypothesis test was performed using a repeated measures analysis of variance model. For the test of non-inferiority, a two-sided 95% confidence intervals for the treatment group difference in mean IOP at each visit and time point was constructed based on analysis of variance.|
1709320|NCT00848484|3145035|Superiority or Other|||||||0.686||||||The Benjamini & Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among 5 secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence * time with a restriction of the same baseline mean across treatment sequences.|||
1709321|NCT00848484|3145036|Superiority or Other|||||||0.686||||||The Benjamini & Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|Wilcoxon (Mann-Whitney)|The repeated measures model included the terms site and sequence * time with a restriction of the same baseline mean across treatment sequences.|||
1709322|NCT00848484|3145037|Superiority or Other|||||||0.686||||||The Benjamini & Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among 5 secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence * time with a restriction of the same baseline mean across treatment sequences.|||
1709323|NCT00848484|3145038|Superiority or Other|||||||0.933||||||The Benjamini & Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence * time with a restriction of the same baseline mean across treatment sequences.|||
1709324|NCT00848484|3145039|Superiority or Other|||||||0.686||||||The Benjamini & Hochberg False Discovery Rate (FDR) approach at critical value 0.1 was used to adjust p-Values among five secondary cognition endpoints.|constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence * time with a restriction of the same baseline mean across treatment sequences.|||
1709325|NCT00848484|3145040|Superiority or Other|||||||0.277|||||||constrained Longitudinal Data Analysis|The repeated measures model included the terms site and sequence * time with a restriction of the same baseline mean across treatment sequences.|||
1709326|NCT00848354|3145050|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.|
1709327|NCT00848354|3145050|Superiority or Other||||||<|0.0073||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.|
1709328|NCT00848354|3145050|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.|
1709329|NCT00848354|3145051|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.|
1709330|NCT00848354|3145051|Superiority or Other||||||<|0.0007||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.|
1709331|NCT00848354|3145051|Superiority or Other||||||<|0.0062||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.|
1709332|NCT00848354|3145052|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.|
1709333|NCT00848354|3145052|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.|
1709820|NCT00841204|3146240|Other|||||||0.58|||||||Regression, Linear||||
1709335|NCT00848354|3145053|Superiority or Other|||||||0.0002||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.|
1709336|NCT00848354|3145053|Superiority or Other|||||||0.0013||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.|
1709337|NCT00848354|3145053|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.|
1709338|NCT00848354|3145054|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.|
1709339|NCT00848354|3145054|Superiority or Other||||||<|0.0036||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.|
1709340|NCT00848354|3145054|Superiority or Other||||||<|0.0066||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.|
1709341|NCT00848354|3145055|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.|
1709342|NCT00848354|3145055|Superiority or Other||||||<|0.073||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.|
1709343|NCT00848354|3145055|Superiority or Other||||||<|0.0061||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.|
1709344|NCT00848354|3145056|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 8, Week 16, and Week 24 - independently).|
1709345|NCT00848354|3145058|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.|
1709346|NCT00848354|3145058|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.|
1709347|NCT00848354|3145058|Superiority or Other||||||<|0.0005||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.|
1709348|NCT00848354|3145060|Superiority or Other|||||||0.0002||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.|
1709349|NCT00848354|3145060|Superiority or Other|||||||0.0264||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.|
1709350|NCT00848354|3145060|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.|
1709351|NCT00848354|3145062|Superiority or Other|||||||0.0003||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.|
1709352|NCT00848354|3145062|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.|
1709353|NCT00848354|3145062|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.|
1709515|NCT00847626|3145221|Superiority or Other||Mean Difference (Final Values)|-17.0|||<|0.001|2-Sided|95.0|-20.4|-13.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709354|NCT00848354|3145063|Superiority or Other|||||||0.0021||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.|
1709355|NCT00848354|3145063|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.|
1709356|NCT00848354|3145063|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.|
1709357|NCT00848354|3145063|Superiority or Other||||||<|0.0007||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.|
1709358|NCT00848354|3145063|Superiority or Other||||||<|0.0002||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.|
1709359|NCT00848354|3145063|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.|
1709360|NCT00848354|3145063|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.|
1709361|NCT00848354|3145065|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).|
1709362|NCT00848354|3145066|Superiority or Other|||||||0.0044||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.|
1709363|NCT00848354|3145067|Superiority or Other|||||||0.1975||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.|
1709364|NCT00848354|3145069|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).|
1709365|NCT00848354|3145071|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).|
1709366|NCT00848354|3145073|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).|
1709367|NCT00848354|3145075|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.|
1709368|NCT00848354|3145075|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.|
1709369|NCT00848354|3145075|Superiority or Other||||||<|0.0005||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.|
1709370|NCT00848354|3145075|Superiority or Other||||||<|0.0007||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.|
1709371|NCT00848354|3145075|Superiority or Other||||||<|0.0009||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.|
1709670|NCT00844805|3145601|Superiority or Other||Difference in Percentages|18.4|||=|0|2-Sided|95.0|2.5|34.3|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.||
1709372|NCT00848354|3145075|Superiority or Other||||||<|0.0007||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.|
1709373|NCT00848354|3145075|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.|
1709374|NCT00848354|3145077|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).|
1709375|NCT00848354|3145079|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).|
1709376|NCT00848354|3145081|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).|
1709377|NCT00848354|3145083|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).|
1709378|NCT00848354|3145085|Superiority or Other||Odds Ratio (OR)|5.73|||<|0.0001|2-Sided|95.0|3.4|9.65||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.|
1709379|NCT00848354|3145085|Superiority or Other||Odds Ratio (OR)|7.88|||<|0.0001|2-Sided|95.0|4.37|14.2||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.|
1709380|NCT00848354|3145085|Superiority or Other||Odds Ratio (OR)|5.7|||<|0.0001|2-Sided|95.0|3.23|10.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.|
1709381|NCT00848354|3145085|Superiority or Other||Odds Ratio (OR)|5.34|||<|0.0001|2-Sided|95.0|3.18|8.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.|
1709382|NCT00848354|3145085|Superiority or Other||Odds Ratio (OR)|4.96|||<|0.0001|2-Sided|95.0|3.05|8.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.|
1709383|NCT00848354|3145085|Superiority or Other||Odds Ratio (OR)|4.65|||<|0.0001|2-Sided|95.0|3.0|7.22||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.|
1709384|NCT00848354|3145085|Superiority or Other||Odds Ratio (OR)|3.67|||<|0.0001|2-Sided|95.0|2.35|5.73||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.|
1709385|NCT00848354|3145087|Superiority or Other||Odds Ratio (OR)|7.84|||<|0.0001|2-Sided|95.0|3.94|15.62||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.|
1709386|NCT00848354|3145087|Superiority or Other||Odds Ratio (OR)|8.38|||<|0.0001|2-Sided|95.0|3.86|18.17||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.|
1709387|NCT00848354|3145087|Superiority or Other||Odds Ratio (OR)|6.53|||<|0.0001|2-Sided|95.0|3.16|13.48||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.|
1709388|NCT00848354|3145087|Superiority or Other||Odds Ratio (OR)|5.25|||<|0.0001|2-Sided|95.0|2.63|10.47||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.|
1709389|NCT00848354|3145087|Superiority or Other||Odds Ratio (OR)|5.23|||<|0.0001|2-Sided|95.0|2.82|9.72||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.|
1709390|NCT00848354|3145087|Superiority or Other||Odds Ratio (OR)|4.01|||<|0.0001|2-Sided|95.0|2.36|6.8||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.|
1709391|NCT00848354|3145087|Superiority or Other||Odds Ratio (OR)|4.53|||<|0.0001|2-Sided|95.0|2.9|7.07||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.|
1709392|NCT00848354|3145089|Superiority or Other||Odds Ratio (OR)|6.51|||<|0.0001|2-Sided|95.0|3.72|11.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.|
1709393|NCT00848354|3145089|Superiority or Other||Odds Ratio (OR)|4.12|||<|0.0001|2-Sided|95.0|2.47|6.87||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.|
1709394|NCT00848354|3145089|Superiority or Other||Odds Ratio (OR)|3.06|||<|0.0001|2-Sided|95.0|1.85|5.05||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.|
1709395|NCT00848354|3145089|Superiority or Other||Odds Ratio (OR)|2.97|||<|0.0001|2-Sided|95.0|1.7|5.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.|
1709396|NCT00848354|3145089|Superiority or Other||Odds Ratio (OR)|2.84|||<|0.0007|2-Sided|95.0|1.5|5.36||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.|
1709397|NCT00848354|3145089|Superiority or Other||Odds Ratio (OR)|2.33|||<|0.0466|2-Sided|95.0|1.0|5.45||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.|
1709398|NCT00848354|3145089|Superiority or Other||Odds Ratio (OR)|7.4|||<|0.025|2-Sided|95.0|0.96|56.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.|
1709399|NCT00848354|3145091|Superiority or Other||Odds Ratio (OR)|9.18|||<|0.0001|2-Sided|95.0|3.61|23.32||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.|
1709400|NCT00848354|3145091|Superiority or Other||Odds Ratio (OR)|5.94|||<|0.0001|2-Sided|95.0|2.88|12.24||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.|
1709401|NCT00848354|3145091|Superiority or Other||Odds Ratio (OR)|4.3|||<|0.0001|2-Sided|95.0|1.99|9.29||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.|
1709402|NCT00848354|3145091|Superiority or Other||Odds Ratio (OR)|2.89|||<|0.0059|2-Sided|95.0|1.31|6.34||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.|
1709403|NCT00848354|3145091|Superiority or Other||Odds Ratio (OR)|2.53|||<|0.0388|2-Sided|95.0|1.02|6.26||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.|
1709404|NCT00848354|3145091|Superiority or Other||Odds Ratio (OR)|2.09|||<|0.4044|2-Sided|95.0|0.58|7.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.|
1709405|NCT00848354|3145091|Superiority or Other||||||<|0.3054||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.|
1709406|NCT00848354|3145093|Superiority or Other||Odds Ratio (OR)|6.51|||<|0.0001|2-Sided|95.0|3.72|11.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.|
1709407|NCT00848354|3145093|Superiority or Other||Odds Ratio (OR)|4.12|||<|0.0001|2-Sided|95.0|2.47|6.87||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.|
1709408|NCT00848354|3145093|Superiority or Other||Odds Ratio (OR)|3.06|||<|0.0001|2-Sided|95.0|1.85|5.05||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.|
1709409|NCT00848354|3145093|Superiority or Other||Odds Ratio (OR)|2.97|||<|0.0001|2-Sided|95.0|1.7|5.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.|
1709410|NCT00848354|3145093|Superiority or Other||Odds Ratio (OR)|2.84|||<|0.0007|2-Sided|95.0|1.5|5.36||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.|
1709411|NCT00848354|3145093|Superiority or Other||Odds Ratio (OR)|2.33|||<|0.0466|2-Sided|95.0|1.0|5.45||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.|
1709694|NCT00844519|3145730|Superiority or Other|||||||0.9||||||significant at p<0.05|t-test, 2 sided|||within-arm, pre-post change in FMD|
1709412|NCT00848354|3145093|Superiority or Other||Odds Ratio (OR)|7.4|||<|0.025|2-Sided|95.0|0.96|56.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.|
1709413|NCT00848354|3145095|Superiority or Other||Odds Ratio (OR)|6.05|||<|0.0001|2-Sided|95.0|3.5|10.47||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.|
1709414|NCT00848354|3145095|Superiority or Other||Odds Ratio (OR)|8.43|||<|0.0001|2-Sided|95.0|4.5|15.8||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.|
1709415|NCT00848354|3145095|Superiority or Other||Odds Ratio (OR)|7.15|||<|0.0001|2-Sided|95.0|3.91|13.09||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.|
1709416|NCT00848354|3145095|Superiority or Other||Odds Ratio (OR)|5.77|||<|0.0001|2-Sided|95.0|3.36|9.93||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.|
1709417|NCT00848354|3145095|Superiority or Other||Odds Ratio (OR)|5.21|||<|0.0001|2-Sided|95.0|3.15|8.61||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.|
1709418|NCT00848354|3145095|Superiority or Other||Odds Ratio (OR)|4.6|||<|0.0001|2-Sided|95.0|2.94|7.18||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.|
1709419|NCT00848354|3145095|Superiority or Other||Odds Ratio (OR)|4.25|||<|0.0001|2-Sided|95.0|2.74|6.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.|
1709420|NCT00848354|3145097|Superiority or Other||Odds Ratio (OR)|6.13|||<|0.0001|2-Sided|95.0|3.82|9.85||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.|
1709421|NCT00848354|3145097|Superiority or Other||Odds Ratio (OR)|4.4|||<|0.0001|2-Sided|95.0|2.8|6.9||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.|
1709422|NCT00848354|3145097|Superiority or Other||Odds Ratio (OR)|4.4|||<|0.0001|2-Sided|95.0|2.78|6.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.|
1709423|NCT00848354|3145097|Superiority or Other||Odds Ratio (OR)|3.2|||<|0.0001|2-Sided|95.0|2.02|5.06||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.|
1709424|NCT00848354|3145097|Superiority or Other||Odds Ratio (OR)|3.52|||<|0.0001|2-Sided|95.0|2.1|5.88||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.|
1709425|NCT00848354|3145097|Superiority or Other||Odds Ratio (OR)|3.87|||<|0.0001|2-Sided|95.0|1.98|7.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.|
1709426|NCT00848354|3145097|Superiority or Other||Odds Ratio (OR)|3.09|||<|0.0349|2-Sided|95.0|1.05|9.13||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.|
1709427|NCT00848354|3145099|Superiority or Other||Odds Ratio (OR)|6.45|||<|0.0001|2-Sided|95.0|3.67|11.33||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.|
1709428|NCT00848354|3145099|Superiority or Other||Odds Ratio (OR)|6.18|||<|0.0001|2-Sided|95.0|3.25|11.73||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.|
1709429|NCT00848354|3145099|Superiority or Other||Odds Ratio (OR)|5.81|||<|0.0001|2-Sided|95.0|3.15|10.74||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.|
1709430|NCT00848354|3145099|Superiority or Other||Odds Ratio (OR)|4.4|||<|0.0001|2-Sided|95.0|2.55|7.58||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.|
1709431|NCT00848354|3145099|Superiority or Other||Odds Ratio (OR)|5.0|||<|0.0001|2-Sided|95.0|2.98|8.41||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.|
1709432|NCT00848354|3145099|Superiority or Other||Odds Ratio (OR)|4.87|||<|0.0001|2-Sided|95.0|3.07|7.71||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.|
1709821|NCT00841204|3146241|Other||||||<|0.05|||||||Regression, Linear||||
1709433|NCT00848354|3145099|Superiority or Other||Odds Ratio (OR)|3.52|||<|0.0001|2-Sided|95.0|2.3|5.4||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.|
1709434|NCT00848354|3145101|Superiority or Other||Odds Ratio (OR)|6.59|||<|0.0001|2-Sided|95.0|3.87|11.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.|
1709435|NCT00848354|3145101|Superiority or Other||Odds Ratio (OR)|5.49|||<|0.0001|2-Sided|95.0|3.16|9.52||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.|
1709436|NCT00848354|3145101|Superiority or Other||Odds Ratio (OR)|5.58|||<|0.0001|2-Sided|95.0|3.19|9.76||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.|
1709437|NCT00848354|3145101|Superiority or Other||Odds Ratio (OR)|3.9|||<|0.0001|2-Sided|95.0|2.37|6.41||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.|
1709438|NCT00848354|3145101|Superiority or Other||Odds Ratio (OR)|3.99|||<|0.0001|2-Sided|95.0|2.5|6.38||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.|
1709439|NCT00848354|3145101|Superiority or Other||Odds Ratio (OR)|4.41|||<|0.0001|2-Sided|95.0|2.85|6.82||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.|
1709440|NCT00848354|3145101|Superiority or Other||Odds Ratio (OR)|3.15|||<|0.0001|2-Sided|95.0|2.04|4.86||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.|
1709441|NCT00848354|3145103|Superiority or Other||Odds Ratio (OR)|7.64|||<|0.0001|2-Sided|95.0|3.74|15.63||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.|
1709442|NCT00848354|3145103|Superiority or Other||Odds Ratio (OR)|6.86|||<|0.0001|2-Sided|95.0|3.0|15.72||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.|
1709443|NCT00848354|3145103|Superiority or Other||Odds Ratio (OR)|6.08|||<|0.0001|2-Sided|95.0|2.74|13.48||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.|
1709444|NCT00848354|3145103|Superiority or Other||Odds Ratio (OR)|4.57|||<|0.0001|2-Sided|95.0|2.27|9.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.|
1709445|NCT00848354|3145103|Superiority or Other||Odds Ratio (OR)|5.94|||<|0.0001|2-Sided|95.0|2.93|12.02||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.|
1709446|NCT00848354|3145103|Superiority or Other||Odds Ratio (OR)|4.99|||<|0.0001|2-Sided|95.0|2.91|8.55||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.|
1709447|NCT00848354|3145103|Superiority or Other||Odds Ratio (OR)|3.5|||<|0.0001|2-Sided|95.0|2.24|5.46||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.|
1709448|NCT00848354|3145104|Superiority or Other||Odds Ratio (OR)|7.79|||<|0.0001|2-Sided|95.0|3.49|17.39||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value.|
1709449|NCT00848354|3145105|Superiority or Other||Odds Ratio (OR)|6.23|||<|0.0001|2-Sided|95.0|3.88|10.0||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value.|
1709450|NCT00848354|3145107|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).|
1709451|NCT00848354|3145109|Superiority or Other||Odds Ratio (OR)|4.2|||<|0.0001|2-Sided|95.0|2.36|7.46||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.|
1709452|NCT00848354|3145109|Superiority or Other||Odds Ratio (OR)|3.65|||<|0.0001|2-Sided|95.0|2.02|6.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.|
1709453|NCT00848354|3145109|Superiority or Other||Odds Ratio (OR)|3.78|||<|0.0001|2-Sided|95.0|2.02|7.09||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.|
1709454|NCT00848354|3145109|Superiority or Other||Odds Ratio (OR)|5.69|||<|0.0001|2-Sided|95.0|2.39|13.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.|
1709455|NCT00848354|3145109|Superiority or Other||Odds Ratio (OR)|5.27|||<|0.0001|2-Sided|95.0|2.04|13.6||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.|
1709456|NCT00848354|3145109|Superiority or Other||Odds Ratio (OR)|3.58|||<|0.0392|2-Sided|95.0|1.04|12.3||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.|
1709457|NCT00848354|3145109|Superiority or Other||Odds Ratio (OR)|5.19|||<|0.1086|2-Sided|95.0|0.66|40.9||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.|
1709458|NCT00848354|3145111|Superiority or Other||Odds Ratio (OR)|4.94|||<|0.0001|2-Sided|95.0|3.13|7.78||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.|
1709459|NCT00848354|3145111|Superiority or Other||Odds Ratio (OR)|3.9|||<|0.0001|2-Sided|95.0|2.45|6.22||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.|
1709460|NCT00848354|3145111|Superiority or Other||Odds Ratio (OR)|3.91|||<|0.0001|2-Sided|95.0|2.46|6.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.|
1709461|NCT00848354|3145111|Superiority or Other||Odds Ratio (OR)|3.2|||<|0.0001|2-Sided|95.0|2.06|4.96||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.|
1709462|NCT00848354|3145111|Superiority or Other||Odds Ratio (OR)|2.9|||<|0.0001|2-Sided|95.0|1.9|4.43||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.|
1709463|NCT00848354|3145111|Superiority or Other||Odds Ratio (OR)|3.34|||<|0.0001|2-Sided|95.0|2.19|5.11||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.|
1709464|NCT00848354|3145111|Superiority or Other||Odds Ratio (OR)|3.84|||<|0.0001|2-Sided|95.0|2.37|6.21||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.|
1709465|NCT00848354|3145113|Superiority or Other||Odds Ratio (OR)|5.39|||<|0.0001|2-Sided|95.0|3.41|8.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.|
1709466|NCT00848354|3145113|Superiority or Other||Odds Ratio (OR)|3.82|||<|0.0001|2-Sided|95.0|2.46|5.93||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.|
1709467|NCT00848354|3145113|Superiority or Other||Odds Ratio (OR)|3.93|||<|0.0001|2-Sided|95.0|2.51|6.16||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.|
1709468|NCT00848354|3145113|Superiority or Other||Odds Ratio (OR)|4.1|||<|0.0001|2-Sided|95.0|2.57|6.53||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.|
1709469|NCT00848354|3145113|Superiority or Other||Odds Ratio (OR)|3.6|||<|0.0001|2-Sided|95.0|2.19|5.94||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.|
1709470|NCT00848354|3145113|Superiority or Other||Odds Ratio (OR)|4.99|||<|0.0001|2-Sided|95.0|2.62|9.49||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.|
1709471|NCT00848354|3145113|Superiority or Other||Odds Ratio (OR)|6.39|||<|0.0001|2-Sided|95.0|2.25|18.2||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Fisher Exact|||Fisher’s exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.|
1709472|NCT00848354|3145116|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).|
1709473|NCT00848354|3145117|Superiority or Other|||||||0.027||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model on ranks of change in mTSS with treatment group and center main effects and the Baseline rank as covariate was used to calculate p-value.|
1709516|NCT00847626|3145221|Superiority or Other||Mean Difference (Final Values)|-11.6|||<|0.001|2-Sided|95.0|-15.0|-8.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709474|NCT00848354|3145118|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for physical component at Week 24.|
1709475|NCT00848354|3145118|Superiority or Other||||||<|0.0002||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for mental component at Week 24.|
1709476|NCT00848354|3145118|Superiority or Other||||||<|0.0003||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for vitality domain at Week 24.|
1709477|NCT00848354|3145119|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|ANCOVA|||Analysis of covariance (ANCOVA) model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.|
1709478|NCT00848354|3145120|Superiority or Other||||||<|0.0001||||||Statistical testing was done at alpha = 0.05 level, two-sided, without any adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel chi-square test, stratified by country, was used to calculate p-value. Assuming ACR50 response at Week 24 to be 23% in the DMARD combination therapy group and 37% in the etanercept + methotrexate group, a study enrolling 276 participants assigned to etanercept + methotrexate and 138 participants assigned to DMARD combination therapy has 80% power to reject the null hypothesis of no difference in response rates testing at the type I error = 0.05 level.|
1709479|NCT00848250|3145121|Superiority|||||||0.41|||||||Fisher Exact||||
1709480|NCT00848250|3145122|Superiority|||||||0.47|||||||t-test, 2 sided|||P-value is for comparison of chest tube output at 24 hours|
1709481|NCT00848250|3145124|Superiority|||||||0.67|||||||ANOVA|Repeated measures|||
1709482|NCT00848250|3145125|Superiority|||||||0.02|||||||ANOVA|Repeated measures|||
1709483|NCT00848250|3145126|Superiority|||||||0.13|||||||ANOVA|Repeated measures|||
1709484|NCT00848250|3145127|Superiority|||||||0.03|||||||ANOVA||||
1709485|NCT00848211|3145134|Superiority or Other|||||||0.045|||||||ANOVA||||
1709486|NCT00848211|3145136|Superiority or Other|||||||0.008|||||||ANOVA||||
1709487|NCT00848198|3145144|Superiority or Other||Specificity|73.3|||||2-Sided|95.0|68.3|78.3|||||||
1709488|NCT00848198|3145144|Superiority or Other||Sensitivity|58.5|||||2-Sided|95.0|52.9|64.1|||||||
1709489|NCT00848198|3145145|Superiority or Other||Specificity|78.7|||||2-Sided|95.0|74.0|83.3|||||||
1709490|NCT00848198|3145145|Superiority or Other||Sensitivity|61.2|||||2-Sided|95.0|55.6|66.7|||||||
1709491|NCT00848198|3145146|Superiority or Other||Specificity|94.7|||||2-Sided|95.0|92.1|97.2|||||||
1709492|NCT00848198|3145146|Superiority or Other||Sensitivity|51.3|||||2-Sided|95.0|45.7|57.0|||||||
1709493|NCT00848198|3145147|Superiority or Other||Specificity|98.7|||||2-Sided|95.0|97.4|100.0|||||||
1709494|NCT00848198|3145147|Superiority or Other||Sensitivity|27.2|||||2-Sided|95.0|22.2|32.3|||||||
1709495|NCT00848198|3145148|Superiority or Other||Specificity|82.7|||||2-Sided|95.0|78.4|87.0|||||||
1709496|NCT00848198|3145148|Superiority or Other||Sensitivity|71.9|||||2-Sided|95.0|66.8|77.0|||||||
1709497|NCT00848198|3145149|Superiority or Other||Specificity|82.7|||||2-Sided|95.0|78.4|87.0|||||||
1709498|NCT00848198|3145149|Superiority or Other||Sensitivity|39.7|||||2-Sided|95.0|34.2|45.3|||||||
1709499|NCT00848198|3145150|Superiority or Other||Specificity|72.0|||||2-Sided|95.0|66.9|77.1|||||||
1709500|NCT00848198|3145150|Superiority or Other||Sensitivity|87.1|||||2-Sided|95.0|83.2|90.9|||||||
1709501|NCT00848185|3145151|Superiority or Other||||||<|0.001|||||||ANOVA|||ANOVA for three groups|
1709502|NCT00848172|3145154|Superiority or Other||||||=|0|||||||Mixed Models Analysis||||
1709503|NCT00848172|3145155|Superiority or Other||||||=|0|||||||Mixed Models Analysis||||
1709504|NCT00848120|3145159|Superiority or Other|||||||0.001|||||||ANOVA|||Week 24 versus baseline|
1709505|NCT00848120|3145160|Superiority or Other||||||<|0.001|||||||ANOVA|||Week 24 versus baseline|
1709506|NCT00848120|3145161|Superiority or Other||||||<|0.001|||||||ANOVA|||Week 24 versus baseline|
1709507|NCT00848081|3145170|Superiority or Other|||||||0.828|||||||ANOVA|P-value is from Type III sums of squares ANOVA on rank-transformed data; p-value is on change from baseline.|||
1709508|NCT00848081|3145171|Superiority or Other|||||||0.258||||||p-value is on change from baseline|ANOVA|The p-value is from Type III sums of squares ANOVA on rank-transformed data.|||
1709509|NCT00848081|3145172|Superiority or Other|||||||0.13||||||p-value is on change from baseline|ANCOVA|||The LS mean, standard error, 2-sided 95% confidence interval and p-value for the difference between placebo and tadalafil 5 mg are from an analysis of covariance (ANCOVA) model.|
1709510|NCT00848081|3145174|Superiority or Other|||||||0.403||||||1-sided test|Fisher Exact|||The p-value is from a one-sided Fisher's exact test with a significance level of 0.05. A total of 142 subjects per treatment arm would provide 91% power to detect the difference between a Group 1 proportion of 0.03 and a Group 2 proportion of 0.13.|
1709511|NCT00847912|3145181|Superiority or Other (legacy)||Hazard Ratio (HR)|1.01||||0.93|2-Sided|95.0|0.82|1.24|||Regression, Cox||||
1709512|NCT00847912|3145182|Superiority or Other (legacy)|||||||0.93|||||||Log Rank||||
1709513|NCT00847626|3145221|Superiority or Other||Mean Difference (Final Values)|-12.8|||<|0.001|2-Sided|95.0|-16.2|-9.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709514|NCT00847626|3145221|Superiority or Other||Mean Difference (Final Values)|-11.2|||<|0.001|2-Sided|95.0|-14.7|-7.8||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709695|NCT00844519|3145730|Superiority or Other|||||||0.17||||||significant at p<0.05|t-test, 2 sided|||within-arm, pre-post change in FMD|
1709517|NCT00847626|3145221|Superiority or Other||Mean Difference (Final Values)|-14.2|||<|0.001|2-Sided|95.0|-17.6|-10.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709518|NCT00847626|3145221|Superiority or Other||Mean Difference (Final Values)|-10.9|||<|0.001|2-Sided|95.0|-14.2|-7.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709519|NCT00847626|3145221|Superiority or Other||Mean Difference (Final Values)|-12.0|||<|0.001|2-Sided|95.0|-15.4|-8.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709520|NCT00847626|3145221|Superiority or Other||Mean Difference (Final Values)|-13.7|||<|0.001|2-Sided|95.0|-17.1|-10.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709521|NCT00847626|3145221|Superiority or Other||Mean Difference (Final Values)|-13.9|||<|0.001|2-Sided|95.0|-17.3|-10.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709522|NCT00847626|3145221|Superiority or Other||Mean Difference (Final Values)|-11.8|||<|0.001|2-Sided|95.0|-15.1|-8.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709523|NCT00847626|3145221|Superiority or Other||Mean Difference (Final Values)|-10.4|||<|0.001|2-Sided|95.0|-13.7|-7.0||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709524|NCT00847626|3145221|Superiority or Other||Mean Difference (Final Values)|-10.3|||<|0.001|2-Sided|95.0|-13.6|-7.0||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709525|NCT00847626|3145234|Superiority or Other||Mean Difference (Final Values)|-18.2|||<|0.001|2-Sided|95.0|-25.9|-10.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.|
1709526|NCT00847626|3145234|Superiority or Other||Mean Difference (Final Values)|-4.8|||<|0.255|2-Sided|95.0|-13.0|3.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.|
1709527|NCT00847626|3145235|Superiority or Other||Mean Difference (Final Values)|-16.0|||<|0.001|2-Sided|95.0|-19.4|-12.6||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709528|NCT00847626|3145235|Superiority or Other||Mean Difference (Final Values)|-12.8|||<|0.001|2-Sided|95.0|-16.3|-9.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709529|NCT00847626|3145235|Superiority or Other||Mean Difference (Final Values)|-16.2|||<|0.001|2-Sided|95.0|-19.7|-12.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709530|NCT00847626|3145235|Superiority or Other||Mean Difference (Final Values)|-13.5|||<|0.001|2-Sided|95.0|-17.0|-9.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709531|NCT00847626|3145235|Superiority or Other||Mean Difference (Final Values)|-17.2|||<|0.001|2-Sided|95.0|-20.6|-13.7||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709532|NCT00847626|3145235|Superiority or Other||Mean Difference (Final Values)|-14.0|||<|0.001|2-Sided|95.0|-17.5|-10.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709533|NCT00847626|3145235|Superiority or Other||Mean Difference (Final Values)|-13.0|||<|0.001|2-Sided|95.0|-16.5|-9.5||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709534|NCT00847626|3145235|Superiority or Other||Mean Difference (Final Values)|-15.8|||<|0.001|2-Sided|95.0|-19.3|-12.3||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709535|NCT00847626|3145235|Superiority or Other||Mean Difference (Final Values)|-12.4|||<|0.001|2-Sided|95.0|-15.8|-8.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709536|NCT00847626|3145235|Superiority or Other||Mean Difference (Final Values)|-15.7|||<|0.001|2-Sided|95.0|-19.2|-12.1||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709537|NCT00847626|3145235|Superiority or Other||Mean Difference (Final Values)|-9.9|||<|0.001|2-Sided|95.0|-13.4|-6.4||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709538|NCT00847626|3145235|Superiority or Other||Mean Difference (Final Values)|-12.7|||<|0.001|2-Sided|95.0|-16.2|-9.2||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed.|
1709539|NCT00847626|3145236|Superiority or Other||Mean Difference (Final Values)|-13.8|||<|0.001|2-Sided|95.0|-16.7|-10.9||Tested at 5% significance level.|ANCOVA|||ANCOVA using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.|
1709581|NCT00846768|3145380|Superiority or Other||Mean Difference (Final Values)|0.057|Standard Error of the Mean|0.027||0.0402||95.0|0.003|0.111|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid||
1709540|NCT00847626|3145236|Superiority or Other||Mean Difference (Net)|-13.0|||<|0.001|2-Sided|95.0|-15.8|-9.5||Tested at 5% significance level.|ANCOVA|||Analysis of covariance model (ANCOVA) using treatment as a fixed effect and baseline as a covariate was performed. Results for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD pool were obtained using contrast with coefficients of 0.5 for Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD and 0.5 for Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD from the ANCOVA model.|
1709541|NCT00847613|3145299|Superiority or Other||Percent difference|5.61||||0.0034|2-Sided|95.0|1.85|9.38||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.|
1709542|NCT00847613|3145299|Superiority or Other||Percent difference|14.4|||<|0.0001|2-Sided|95.0|9.44|19.36||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal approximation|||Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.|
1709543|NCT00847613|3145300|Superiority or Other||Least squares mean difference|-0.25|Standard Error of the Mean|0.05||0.0002|2-Sided|95.0|-0.34|-0.16||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in mTSS had to be statistically significant.|Mixed Models Analysis|||Change at Month 3: Least squares mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.|
1709544|NCT00847613|3145300|Superiority or Other||Least squares mean difference|-0.4|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.49|-0.31||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in mTSS had to be significant.|Mixed Models Analysis|||Change at Month 3: Least squares mean difference and corresponding 95% confidence interval (CI) was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.|
1709545|NCT00847613|3145301|Superiority or Other||Least squares mean difference|-0.34|Standard Error of the Mean|0.2||0.0792|2-Sided|95.0|-0.73|0.04||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Mixed Models Analysis|||Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.|
1709546|NCT00847613|3145301|Superiority or Other||Least squares mean difference|-0.4|Standard Error of the Mean|0.19||0.0376|2-Sided|95.0|-0.79|-0.02||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in ACR20 had to be significant.|Mixed Models Analysis|||Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.|
1709547|NCT00847613|3145302|Superiority or Other||Percent difference|26.13|||<|0.0001|2-Sided|95.0|17.28|34.97||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.|
1709548|NCT00847613|3145302|Superiority or Other||Percent difference|36.48|||<|0.0001|2-Sided|95.0|27.73|45.23||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.|
1709549|NCT00847587|3145303|Superiority or Other||Risk Difference (RD)|0.61|Standard Deviation|1.8|<|0.05|2-Sided|95.0|-1.3|2.5|||t-test, 2 sided||||
1709550|NCT00847587|3145304|Non-Inferiority or Equivalence|A noninferiority margin of 8 additional hours was chosen to be clinically relevant, as many common medical interventions (such as epidural anesthesia, cesarean delivery, labor induction, and general stress) have been reported to delay time to lactogenesis stage II by up to 12 hours.|Mean Difference (Final Values)|0.03|Standard Deviation|120.0|<|0.05|2-Sided|95.0|-10.6|7.7|||t-test, 2 sided|||It was assumed that both groups would have a mean of 54 hours to lactogenesis with a common standard deviation of 12 hours based on previous reports of lactogenesis in women with uncomplicated vaginal deliveries. Setting the noninferiority margin at 8 additional hours, using an alpha 0.05 level comparison, to achieve 80% power a sample size of n=34 evaluable subjects was required in each group. The calculation was performed using N Solution 2007 Professional Software.|
1709551|NCT00847405|3145314|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|103.25||||||90.0|98.35|108.41|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1709552|NCT00847405|3145315|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|102.81||||||90.0|97.95|107.91|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1709553|NCT00847405|3145316|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|103.64||||||90.0|95.93|111.97|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1709554|NCT00847288|3145323|Superiority or Other||Odds Ratio (OR)|1.44||||0.0001|2-Sided|95.0|1.2|1.74|||logistic GEE for repeated observations|||The probability of action taken in three months interval is evaluated using the generalized estimating equations (GEE) method under a logistic regression model. Univariate analysis is performed first for potential predictors and only those with a p-value less than 0.10 through univariate analysis are included in the multivariate model. Here we report the odds ratio of monthly arm against quarterly arm, adjusting for OptiVol crossing, new or chronic device, and AF or no AF.|
1709555|NCT00847288|3145325|Superiority or Other||Hazard Ratio (HR)|1.5||||0.0043|2-Sided|95.0|1.1|2.0||Cox proportional hazard model was fitted with the group effect and other key baseline variables. The p-value for the main group effect is 0.0043, with an estimated hazard ratio of 1.5, monthly vs quarterly.|Regression, Cox|||"Let TM and TQ denote the median survival time to initiation of clinical action in monthly and quarterly review groups respectively. Null Hypothesis (HO): The time to initiation of clinical action is not affected by review frequency (monthly versus quarterly): TM=TQ Alternative Hypothesis (HA): The time to initiation of clinical action is affected by review frequency (monthly versus quarterly): TM≠TQ~Cox proportional hazard model will be fitted to estimate the hazard ratio."|
1709556|NCT00847210|3145330|Superiority or Other||Ratio of the central values for dose-nor|1.168||||0.388|2-Sided|90.0|0.864|1.579|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-24) between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For Tmax, an ANOVA model was fitted that included fixed effect of age group (12-14 years and 15 17 years), regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P>0.05). Pairwise comparisons between regimens were conducted.|
1709557|NCT00847210|3145331|Superiority or Other||Ratio of the dose-normalized AUC(0-tlqc)|1.158||||0.402|2-Sided|90.0|0.864|1.551|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole AUC(0-tlqc) between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For Tmax, an ANOVA model was fitted that included fixed effect of age group (12-14 years and 15 17 years), regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P>0.05). Pairwise comparisons between regimens were conducted.|
1709558|NCT00847210|3145332|Superiority or Other||ratio of the central values for Cmax|1.21||||0.289|2-Sided|90.0|0.897|1.63|||ANOVA||Ninety percent confidence intervals for assessing the dose proportionality of dexlansoprazole pharmacokinetics between regimens were computed based on the frame work of ANOVA.|This study was not powered for any hypothesis testing. For natural logarithm of dose-normalized Cmax, an ANOVA model was fitted that included fixed effect of age group, regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. Site effect was tested in the model, and was not included in the final model if not statistically significant (P>0.05). Pairwise comparisons between regimens were conducted.|
1709559|NCT00847210|3145333|Superiority or Other|||||||0.095||||||There was no statistical significant difference (p-value >0.05) in Tmax between the 30 mg and 60 mg dose group. Both age group and site did not have statistically significant effects on Tmax.|ANOVA|||This study was not powered for any hypothesis testing. For Tmax, an analysis of variance (ANOVA) model was fitted that included fixed effect of age group, regimen and interaction of age group and regimen. If the interaction term was not statistically significant, it was not included in the final model. The site effect was also tested in the model, and was not included in the final model if it was not statistically significant (P>0.05). Pairwise comparisons between regimens were conducted.|
1709560|NCT00847197|3145334|Superiority or Other||Median Difference (Final Values)|-10.3|Standard Error of the Mean|8.6||0.02|2-Sided|95.0|-18.9|-1.9|||Wilcoxon's Rank Sum Test|The significance test was 2-tailed with α=0.05.||Triglycerides was analyzed by non-parametric methods with terms for treatment, gender and region. Specifically, the analysis of variance (ANOVA) model was applied to the Tukey’s normal scores of the percent change from baseline. The estimate of the difference in medians between MK1903 and the placebo groups utilizing the Hodges-Lehmann estimate and a distribution-free 95% CI for the difference based on Wilcoxon’s rank sum test was provided.|
1709561|NCT00847197|3145335|Superiority or Other||Mean Difference (Final Values)|4.6|Standard Error of the Mean|1.8||0.013|2-Sided|95.0|1.0|8.1||The significance test was 2-tailed with α=0.05.|Mixed Models Analysis|The test for the treatment difference in terms of percentage change from baseline to a given time point was done using the contrast statement.||For the analysis of percent change from baseline in LDL-C at study endpoint, a Longitudinal Analysis of Covariance (ANCOVA) method was used. The repeated measures model included terms for treatment, time (Day 15, 29), and the interaction of time-by-treatment. The analysis model also adjusted for baseline, baseline-by-time interaction, region and gender.|
1709562|NCT00847197|3145336|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|2.1||0.926|2-Sided|95.0|-3.9|4.3||The significance test was 2-tailed with α=0.05.|Mixed Models Analysis|The test for the treatment difference in terms of percentage change from baseline to a given time point was done using the contrast statement.||For the analysis of percent change from baseline in LDL-C at study endpoint, a Longitudinal Analysis of Covariance (ANCOVA) method was used. The repeated measures model included terms for treatment, time (Day 15, 29), and the interaction of time-by-treatment. The analysis model also adjusted for baseline, baseline-by-time interaction, region and gender.|
1709563|NCT00847145|3145353|Non-Inferiority or Equivalence|The specified cut-off level for the varicella vaccine antigen is ≥5 gp ELISA units/ml (seroprotection) to be greater than -10%.|Percentage group difference|-2.0|||||2-Sided|95.0|-11.0|7.0||||||The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of the subjects with antibody response greater than or equal to the specified cut-off value for varicella antigen was greater than -10%.|
1709647|NCT00844857|3145577|Superiority or Other|||||||0.667||||||P-value for Suicidal Behavior. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.|
1709564|NCT00847145|3145353|Non-Inferiority or Equivalence|The specified cut-off value for the vaccine antigen varicella is ≥1.25 gpELISA units/mL to be greater than -10%.|Percentage group difference|-1.0|||||2-Sided|95.0|-6.0|3.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for varicella antigen was greater than -10%.|
1709565|NCT00847145|3145353|Non-Inferiority or Equivalence|The specified cut-off level for the vaccine antigen rubella is ≥10 IU/mL to be greater than -10%.|Percentage group difference|-1.0|||||2-Sided|95.0|-4.0|1.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the rubella antigen(two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for rubella antigen was greater than -10%.|
1709566|NCT00847145|3145353|Non-Inferiority or Equivalence|The specified cut-off level for the vaccine antigen mumps is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody (Ab) units to be greater than -10%.|Percentage group difference|0.0|||||2-Sided|95.0|-5.0|5.0||||||The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B(2a), if for the mumps antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Mumps antigen was greater than -10%.|
1709567|NCT00847145|3145353|Non-Inferiority or Equivalence|The specified cut-off levels for the vaccine antigen measles is ≥255 mIU/mL to be greater than -10%.|Percentage group difference|-1.0|||||2-Sided|95.0|-5.0|2.0||||||The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the measles antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Measles antigen was greater than -10%.|
1709568|NCT00846885|3145362|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|105.0||||||90.0|101.0|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1709569|NCT00846885|3145363|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|106.0||||||90.0|102.0|111.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1709570|NCT00846885|3145364|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|110.0||||||90.0|103.0|117.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1709571|NCT00846768|3145378|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.04||0.0802||95.0|-0.009|0.149|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid||
1709572|NCT00846768|3145378|Superiority or Other||Mean Difference (Final Values)|-0.015|Standard Error of the Mean|0.039||0.6991||95.0|-0.093|0.063|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd||
1709573|NCT00846768|3145378|Superiority or Other||Mean Difference (Final Values)|0.066|Standard Error of the Mean|0.04||0.0985||95.0|-0.012|0.145|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid||
1709574|NCT00846768|3145378|Superiority or Other||Mean Difference (Final Values)|-0.004|Standard Error of the Mean|0.039||0.919||95.0|-0.082|0.074|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid||
1709575|NCT00846768|3145378|Superiority or Other||Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.04||0.6259||95.0|-0.097|0.059|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid||
1709576|NCT00846768|3145379|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.034||0.4891||95.0|-0.044|0.091|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid||
1709577|NCT00846768|3145379|Superiority or Other||Mean Difference (Final Values)|0.016|Standard Error of the Mean|0.034||0.6268||95.0|-0.05|0.083|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd||
1709578|NCT00846768|3145379|Superiority or Other||Mean Difference (Final Values)|0.092|Standard Error of the Mean|0.034||0.0078||95.0|0.025|0.159|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid||
1709579|NCT00846768|3145379|Superiority or Other||Mean Difference (Final Values)|0.068|Standard Error of the Mean|0.034||0.045||95.0|0.002|0.135|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid||
1709580|NCT00846768|3145379|Superiority or Other||Mean Difference (Final Values)|0.084|Standard Error of the Mean|0.034||0.0133||95.0|0.018|0.151|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid||
1709696|NCT00844480|3145732|Superiority|||||||0.03|||||||t-test, 2 sided||||
1709582|NCT00846768|3145380|Superiority or Other||Mean Difference (Final Values)|0.004|Standard Error of the Mean|0.027||0.8877||95.0|-0.05|0.057|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd||
1709583|NCT00846768|3145380|Superiority or Other||Mean Difference (Final Values)|0.026|Standard Error of the Mean|0.027||0.3386||95.0|-0.028|0.08|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid||
1709584|NCT00846768|3145380|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.027||0.2638||95.0|-0.084|0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid||
1709585|NCT00846768|3145380|Superiority or Other||Mean Difference (Final Values)|-0.027|Standard Error of the Mean|0.027||0.3291||95.0|-0.08|0.027|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid||
1709586|NCT00846768|3145381|Superiority or Other||Mean Difference (Final Values)|0.079|Standard Error of the Mean|0.032||0.0146||95.0|0.016|0.142|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid||
1709587|NCT00846768|3145381|Superiority or Other||Mean Difference (Final Values)|0.004|Standard Error of the Mean|0.032||0.9087||95.0|-0.059|0.066|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd||
1709588|NCT00846768|3145381|Superiority or Other||Mean Difference (Final Values)|-0.024|Standard Error of the Mean|0.032||0.4508||95.0|-0.087|0.039|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid||
1709589|NCT00846768|3145381|Superiority or Other||Mean Difference (Final Values)|-0.103|Standard Error of the Mean|0.032||0.0015||95.0|-0.165|-0.04|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid||
1709590|NCT00846768|3145381|Superiority or Other||Mean Difference (Final Values)|-0.099|Standard Error of the Mean|0.032||0.0023||95.0|-0.162|-0.036|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid||
1709591|NCT00846768|3145382|Superiority or Other||Mean Difference (Final Values)|0.032|Standard Error of the Mean|0.027||0.2444||95.0|-0.022|0.086|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid||
1709592|NCT00846768|3145382|Superiority or Other||Mean Difference (Final Values)|0.004|Standard Error of the Mean|0.027||0.8683||95.0|-0.049|0.058|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd||
1709593|NCT00846768|3145382|Superiority or Other||Mean Difference (Final Values)|0.073|Standard Error of the Mean|0.027||0.008||95.0|0.019|0.127|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid||
1709594|NCT00846768|3145382|Superiority or Other||Mean Difference (Final Values)|0.041|Standard Error of the Mean|0.027||0.1273||95.0|-0.012|0.095|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid||
1709595|NCT00846768|3145382|Superiority or Other||Mean Difference (Final Values)|0.046|Standard Error of the Mean|0.027||0.0917||95.0|-0.008|0.099|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid||
1709596|NCT00846768|3145383|Superiority or Other||Mean Difference (Final Values)|0.036|Standard Error of the Mean|0.02||0.0731||95.0|-0.003|0.075|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid||
1709597|NCT00846768|3145383|Superiority or Other||Mean Difference (Final Values)|-0.021|Standard Error of the Mean|0.02||0.2902||95.0|-0.06|0.018|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd||
1709598|NCT00846768|3145383|Superiority or Other||Mean Difference (Final Values)|0.015|Standard Error of the Mean|0.02||0.4553||95.0|-0.024|0.054|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid||
1709599|NCT00846768|3145383|Superiority or Other||Mean Difference (Final Values)|-0.021|Standard Error of the Mean|0.02||0.2875||95.0|-0.06|0.018|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid||
1709600|NCT00846768|3145383|Superiority or Other||Mean Difference (Final Values)|-0.042|Standard Error of the Mean|0.02||0.0353||95.0|-0.081|-0.003|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid||
1709601|NCT00846768|3145384|Superiority or Other||Mean Difference (Final Values)|0.042|Standard Error of the Mean|0.018||0.0175||95.0|0.008|0.077|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid||
1709602|NCT00846768|3145384|Superiority or Other||Mean Difference (Final Values)|-0.008|Standard Error of the Mean|0.017||0.6578||95.0|-0.042|0.027|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd||
1709603|NCT00846768|3145384|Superiority or Other||Mean Difference (Final Values)|0.062|Standard Error of the Mean|0.018||0.0006||95.0|0.027|0.097|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid||
1709604|NCT00846768|3145384|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.017||0.2597||95.0|-0.015|0.054|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid||
1709605|NCT00846768|3145384|Superiority or Other||Mean Difference (Final Values)|0.012|Standard Error of the Mean|0.017||0.4931||95.0|-0.023|0.047|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid||
1709606|NCT00846768|3145385|Superiority or Other||Mean Difference (Final Values)|0.035|Standard Error of the Mean|0.014||0.0129||95.0|0.007|0.062|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid||
1709607|NCT00846768|3145385|Superiority or Other||Mean Difference (Final Values)|-0.006|Standard Error of the Mean|0.014||0.6789||95.0|-0.033|0.021|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd||
1709608|NCT00846768|3145385|Superiority or Other||Mean Difference (Final Values)|0.022|Standard Error of the Mean|0.014||0.1161||95.0|-0.005|0.049|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid||
1709609|NCT00846768|3145385|Superiority or Other||Mean Difference (Final Values)|-0.013|Standard Error of the Mean|0.014||0.3444||95.0|-0.04|0.014|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid||
1709610|NCT00846768|3145385|Superiority or Other||Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.014||0.1753||95.0|-0.045|0.008|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid||
1709611|NCT00846768|3145386|Superiority or Other||Mean Difference (Final Values)|0.035|Standard Error of the Mean|0.015||0.0211||95.0|0.005|0.064|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid||
1709612|NCT00846768|3145386|Superiority or Other||Mean Difference (Final Values)|-0.006|Standard Error of the Mean|0.015||0.709||95.0|-0.035|0.024|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd||
1709613|NCT00846768|3145386|Superiority or Other||Mean Difference (Final Values)|-0.012|Standard Error of the Mean|0.015||0.4111||95.0|-0.041|0.017|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid||
1709614|NCT00846768|3145386|Superiority or Other||Mean Difference (Final Values)|-0.047|Standard Error of the Mean|0.015||0.0019||95.0|-0.076|-0.017|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid||
1709615|NCT00846768|3145386|Superiority or Other||Mean Difference (Final Values)|-0.052|Standard Error of the Mean|0.015||0.0006||95.0|-0.081|-0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid||
1709616|NCT00846768|3145387|Superiority or Other||Mean Difference (Final Values)|0.033|Standard Error of the Mean|0.015||0.0248||95.0|0.004|0.063|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg bid minus Olo 2 mcg bid||
1709617|NCT00846768|3145387|Superiority or Other||Mean Difference (Final Values)|-0.006|Standard Error of the Mean|0.015||0.7046||95.0|-0.034|0.023|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg qd||
1709618|NCT00846768|3145387|Superiority or Other||Mean Difference (Final Values)|0.054|Standard Error of the Mean|0.015||0.0003||95.0|0.025|0.083|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 2 mcg bid||
1709619|NCT00846768|3145387|Superiority or Other||Mean Difference (Final Values)|0.021|Standard Error of the Mean|0.015||0.1582||95.0|-0.008|0.05|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 5 mcg qd minus Olo 5 mcg bid||
1709620|NCT00846768|3145387|Superiority or Other||Mean Difference (Final Values)|0.015|Standard Error of the Mean|0.015||0.3011||95.0|-0.014|0.044|||Mixed Models Analysis|Means adjusted using a mixed effects model with treatment and period as fixed effects and period as repeated effect with patient as repeated subject.|Olo 10 mcg qd minus Olo 5 mcg bid||
1709621|NCT00846742|3145395|Superiority|||||||0.0003||||||Comparison of proportion of patients’ complete response rate between HOD99 (NCT number: NCT00145600) and HOD08|Exact Binominal Test|||The proportion of patients’ complete response rate was provided with a 95% confidence interval.|
1709622|NCT00846365|3145431|Superiority or Other||Mean Difference (Final Values)|-7.2|||<|0.001|2-Sided|95.0|-9.1|-5.2||Tested at the 0.05 significance level.|ANCOVA|||Statistical analysis for Week 8. ANOVA model with treatment as a fixed effect. Post-baseline p-values are obtained from an ANCOVA model with treatment as a fixed effect and baseline as a covariate.|
1709623|NCT00846365|3145431|Superiority or Other||Mean Difference (Final Values)|-5.6|||<|0.001|2-Sided|95.0|-7.5|-3.7||Tested at the 0.05 significance level.|ANCOVA|||Statistical analysis for Week 8. ANOVA model with treatment as a fixed effect. Post-baseline p-values are obtained from an ANCOVA model with treatment as a fixed effect and baseline as a covariate.|
1709624|NCT00846365|3145435|Superiority or Other||Median Difference (Final Values)|-7.2|||<|0.001|2-Sided|95.0|-9.6|-4.8||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.|
1709625|NCT00846365|3145435|Superiority or Other||Mean Difference (Final Values)|-6.1|||<|0.001|2-Sided|95.0|-8.5|-3.7||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.|
1709626|NCT00846365|3145436|Superiority or Other||Mean Difference (Final Values)|-6.7|||<|0.001|2-Sided|95.0|-9.1|-4.4||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||ANCOVA model with treatment as a fixed effect and Baseline as a covariate.|
1709627|NCT00846365|3145436|Superiority or Other||Mean Difference (Final Values)|-6.1|||<|0.001|2-Sided|95.0|-8.4|-3.8||Statistical significance was set at the 0.05 level per the predefined stepwise testing strategy used.|ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and Baseline as a covariate.|
1709628|NCT00845663|3145496|Non-Inferiority or Equivalence|Use of the 80-125 % bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|97.54||||||90.0|87.33|108.94|||||Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval|
1709629|NCT00845663|3145497|Non-Inferiority or Equivalence|Use of the 80-125% bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|97.7||||||90.0|89.06|107.19|||||Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval|
1709630|NCT00845663|3145498|Non-Inferiority or Equivalence|Use of the 80-125 % bioequivalence range. If 90% confidence interval for ratio of geometric LS Means (percent) is included within these limits, the devices are considered bioequivalent.|ratio of geometric LS Means (percent)|101.33||||||90.0|92.84|110.58|||||Ratio is Auto-injection device/Pre-filled syringe|Bioequivalence testing by using the 90% Confidence Interval|
1709631|NCT00845182|3145528|Superiority or Other||||||<|0.05|||||||ANOVA||||
1709632|NCT00845182|3145528|Superiority or Other||||||<|0.05|||||||ANCOVA||||
1709633|NCT00844857|3145566|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.|
1709634|NCT00844857|3145567|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.|
1709635|NCT00844857|3145568|Superiority or Other|||||||0.005||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.|
1709636|NCT00844857|3145569|Superiority or Other||||||<|0.001||||||P-value for Fasting Triglycerides. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.|
1709637|NCT00844857|3145569|Superiority or Other||||||<|0.001||||||P-value for Fasting Cholesterol. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.|
1709638|NCT00844857|3145569|Superiority or Other||||||<|0.98||||||P-value for Fasting Glucose. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.|
1709639|NCT00844857|3145570|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.|
1709640|NCT00844857|3145571|Superiority or Other|||||||0.05||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.|
1709641|NCT00844857|3145572|Superiority or Other|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.|
1709642|NCT00844857|3145573|Superiority or Other|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.|
1709643|NCT00844857|3145574|Superiority or Other|||||||0.066||||||The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.|
1709644|NCT00844857|3145575|Superiority or Other|||||||0.545||||||P-value for ADHDRS-IV-PI Total Score. The a priori threshold for statistical significance was 0.05. ANCOVA Model terms included baseline, country and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.|
1709645|NCT00844857|3145576|Superiority or Other|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.|
1709646|NCT00844857|3145577|Superiority or Other|||||||0.309||||||P-value for Suicidal Ideation or Behavior. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.|
1709669|NCT00844805|3145600|Superiority or Other||Difference in Percentages|8.4|||=|0|2-Sided|95.0|-6.0|22.8|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.||
1709648|NCT00844857|3145577|Superiority or Other|||||||0.309||||||P-value for Suicidal Ideation. The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.|
1709649|NCT00844857|3145578|Superiority or Other|||||||1||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.|
1709650|NCT00844857|3145579|Superiority or Other|||||||0.002||||||The a priori threshold for statistical significance was 0.05. ANCOVA (analysis of covariance) Model terms included baseline, country, and treatment.|ANCOVA|||Tested was the null hypothesis that there was no difference in mean changes from baseline to up to Week 8 between OFC and placebo.|
1709651|NCT00844857|3145580|Superiority or Other|||||||0.03||||||The a priori threshold for statistical significance was 0.05. MMRM terms included baseline, country, treatment, visit, and treatment*visit interaction|Mixed Models Analysis|||Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.|
1709652|NCT00844857|3145581|Superiority or Other|||||||0.527||||||The a priori threshold for statistical significance was 0.05. MMRM terms included baseline, country, treatment, visit, and treatment*visit interaction.|Mixed Models Analysis|||Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.|
1709653|NCT00844857|3145582|Superiority or Other|||||||0.007||||||The a priori threshold for statistical significance was 0.05. Ordinal Logistic Regression Model terms include baseline CDRS-R, baseline YMRS, and treatment.|Ordinal Logistic Regression|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.|
1709654|NCT00844857|3145583|Superiority or Other|||||||0.003||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.|
1709655|NCT00844857|3145584|Superiority or Other|||||||0.035||||||The a priori threshold for statistical significance was 0.05.|Fisher Exact|||Tested was the null hypothesis that there was no difference in proportions between OFC and placebo.|
1709656|NCT00844857|3145585|Superiority or Other|||||||0.003||||||The a priori threshold for statistical significance was 0.05. Mixed Model Repeated Measures Analysis (MMRM) terms included baseline, country, treatment, visit, and treatment * visit interaction.|Mixed Models Analysis|||"Tested was the null hypothesis that there was no difference in mean changes from baseline to Week 8 between OFC and placebo.~A conservative estimate of effect size of 0.4 was used in the sample size estimation for this study. A randomized ratio of 2:1 provided a 90% power with an effect size of 0.4."|
1709657|NCT00844844|3145587|Superiority or Other||Mean Difference (Final Values)|-0.78|||<|0.0001|2-Sided||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709658|NCT00844844|3145588|Superiority or Other||Percent of complete TMA response|76.0|||||2-Sided|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709659|NCT00844844|3145589|Superiority or Other||Percent of hematologic normalization|88.0|||||2-Sided|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709660|NCT00844844|3145590|Superiority or Other||Percent of platelet count normalization|88.0|||||2-Sided|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709661|NCT00844844|3145591|Superiority or Other||LS mean change from baseline|111.62|||<|0.0001|2-Sided|95.0|98.12|125.13|||ANOVA|Change from baseline was analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709662|NCT00844844|3145592|Superiority or Other||Mean Difference (Final Values)|-0.78|||<|0.0001|2-Sided||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709663|NCT00844844|3145593|Superiority or Other||Percent of complete TMA response|65.0|||||2-Sided|95.0|38.0|86.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709664|NCT00844844|3145594|Superiority or Other||Percent of hematologic normalization|76.0|||||2-Sided|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709665|NCT00844844|3145595|Superiority or Other||Percent of platelet count normalization|82.0|||||2-Sided|95.0|57.0|96.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709666|NCT00844844|3145596|Superiority or Other||LS mean change from baseline|65.18|||<|0.0001|2-Sided|95.0|37.01|93.36|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||With at least 12 patients enrolled and assuming a null hypothesis of no post-dose change from baseline in mean platelet count, the study had approximately 88% power to detect as statistically significant an effect size (mean change from baseline/standard deviation) of at least 1 when using a one sample t-test with a two-sided α=0.05. All analyses were based on the pooled data from the two protocols:C08-002A (adult) and C08-002B (Adolescent), a similar protocol, for patients <18 years with aHUS.|
1709667|NCT00844831|3145597|Other|||||||0.9|||||||Wilcoxon (Mann-Whitney)||||
1709668|NCT00844831|3145599|Superiority|||||||0.75|||||||t-test, 2 sided||||
1709794|NCT00842153|3146178|Superiority or Other|||||||0.0015||||||P-value for Week 4|Chi-squared||||
1709671|NCT00844805|3145602|Superiority or Other||Difference in Percentages|-5.0|||=|0|2-Sided|95.0|-14.5|4.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.||
1709672|NCT00844805|3145603|Superiority or Other||||||=|0|||||||Log Rank||||
1709673|NCT00844805|3145604|Superiority or Other||Difference in Percentages|0.0|||=|0|2-Sided|95.0|-6.8|6.8|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.||
1709674|NCT00844805|3145605|Superiority or Other||Difference in Percentages|-2.5|||=|0|2-Sided|95.0|-14.9|9.9|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.||
1709675|NCT00844805|3145606|Superiority or Other||Difference in Percentages|10.0|||=|0|2-Sided|95.0|-11.7|31.7|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.||
1709676|NCT00844805|3145607|Superiority or Other||Difference in Percentages|18.1|||=|0|2-Sided|95.0|10.7|25.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.||
1709677|NCT00844805|3145608|Superiority or Other||Difference in Percentages|21.7|||=|0|2-Sided|95.0|11.0|32.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.||
1709678|NCT00844805|3145609|Superiority or Other||Difference in Percentages|14.9|||=|0|2-Sided|95.0|-1.7|31.5|||Fisher Exact||The 95% CI for treatment differences were computed using Wilson's Method.||
1709679|NCT00844753|3145617|Superiority or Other|||||||0.95|||||||Chi-squared||||
1709680|NCT00844753|3145618|Superiority or Other|||||||0.47|||||||Chi-squared||||
1709681|NCT00844649|3145624|Superiority or Other (legacy)||Response Rate Ratio|3.19|||<|0.0001|2-Sided|95.0|2.178|4.662|||Chi-squared||Response rate ratio: albumin-bound paclitaxel + gemcitabine /gemcitabine alone|PA+G/PG = response rate ratio of albumin bound paclitaxel + gemcitabine / gemcitabine.|
1709682|NCT00844649|3145625|Superiority or Other (legacy)||Hazard Ratio (HR)|0.69|||<|0.0001|2-Sided|95.0|0.581|0.821||P-value was based on a stratified log-rank test by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis (yes vs no)|Stratified Log-rank Test||Hazard ratio of Albumin bound paclitaxel + gemcitabine / gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.||
1709683|NCT00844649|3145626|Superiority or Other (legacy)||Hazard Ratio (HR)|0.72|||<|0.0001|2-Sided|95.0|0.617|0.835||P-value was based on a stratified log-rank test stratified by randomization strata of geographic region (North America versus Others), Karnofsky performance score (70 to 80 versus 90 to 100), and presence of liver metastasis|Stratified Log-rank Test||Hazard ratio of Albumin bound paclitaxel + gemcitabine/gemcitabine alone. The associated hazard ratio and two-sided 95% confidence interval were estimated using a stratified Cox proportional hazard model.||
1709684|NCT00844545|3145639|Superiority or Other||Mean Difference (Final Values)|-0.78|||<|0.0001|2-Sided||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709685|NCT00844545|3145640|Superiority or Other||Percent of complete TMA response|76.0|||||2-Sided|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709686|NCT00844545|3145641|Superiority or Other||Percent of hematologic normalization|88.0|||||2-Sided|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709687|NCT00844545|3145642|Superiority or Other||Percent of platelet count normalization|88.0|||||2-Sided|95.0|64.0|99.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709688|NCT00844545|3145643|Superiority or Other||LS mean change from baseline|111.62|||<|0.0001|2-Sided|95.0|98.12|125.13|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709689|NCT00844545|3145644|Superiority or Other||Mean Difference (Final Values)|-0.78|||<|0.0001|2-Sided||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709690|NCT00844545|3145645|Superiority or Other||Percent of complete TMA response|65.0|||||2-Sided|95.0|38.0|86.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709691|NCT00844545|3145646|Superiority or Other||Percent of hematologic normalization|76.0|||||2-Sided|95.0|50.0|93.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709692|NCT00844545|3145647|Superiority or Other||Percent of platelet count normalization|82.0|||||2-Sided|95.0|57.0|96.0||||||All analyses were based on the pooled data from the two protocols: protocol C08-002A for adult patients with aHUS and protocol C08-002B, a similar protocol, for patients < 18 years of age for adolescent patients with aHUS.|
1709693|NCT00844545|3145648|Superiority or Other||LS mean change from baseline|65.18|||<|0.0001|2-Sided|95.0|37.01|93.36|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||With at least 12 patients enrolled and assuming a null hypothesis of no post-dose change from baseline in mean platelet count, the study had approximately 88% power to detect as statistically significant an effect size (mean change from baseline/standard deviation) of at least 1 when using a one sample t-test with a two-sided α=0.05. All analyses were based on the pooled data from the two protocols: C08-002A (adult) and C08-002B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709697|NCT00844428|3145734|Superiority or Other||Percent of platelet count normalization|90.0|||||2-Sided|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years|
1709698|NCT00844428|3145735|Superiority or Other||LS mean change from baseline|-3.68||||0.7307|2-Sided|95.0|-25.15|17.79|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709699|NCT00844428|3145736|Superiority or Other||Mean Difference (Final Values)|-0.29|||<|0.0001|2-Sided||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709700|NCT00844428|3145737|Superiority or Other||Percent of complete TMA response|55.0|||||2-Sided|95.0|32.0|77.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709701|NCT00844428|3145738|Superiority or Other||Percent of hematologic normalization|90.0|||||2-Sided|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709702|NCT00844428|3145739|Superiority or Other||Percent of TMA event-free responders|95.0|||||2-Sided|95.0|75.0|100.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709703|NCT00844428|3145740|Superiority or Other||Percent of platelet count normalization|90.0|||||2-Sided|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years|
1709704|NCT00844428|3145741|Superiority or Other||LS mean change from baseline|6.75||||0.5423|2-Sided|95.0|-15.73|29.23|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years|
1709705|NCT00844428|3145742|Superiority or Other||Median Difference (Final Values)|-0.29|||<|0.0001|2-Sided||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709706|NCT00844428|3145743|Superiority or Other||Percent of complete TMA response|25.0|||||2-Sided|95.0|9.0|49.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709707|NCT00844428|3145744|Superiority or Other||Percent of hematologic normalization|90.0|||||2-Sided|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709708|NCT00844428|3145745|Superiority or Other||Percent of TMA event-free responders|80.0|||||2-Sided|95.0|56.0|94.0||||||"With a total of 20 patients enrolled between both protocols and, assuming that the true expected probability of TMA Event-Free for eculizumab-treated patients is 40%, then the study had 93.5% power to detect a statistically significant difference. Up to approximately 30 patients were to be enrolled.~All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS."|
1709709|NCT00844376|3145760|Superiority or Other||ratio of adjusted geometric means|117.9||||||90.0|98.22|141.53|||||Natural log transformed Cmax was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for Cmax|
1709710|NCT00844376|3145761|Superiority or Other||ratio of adjusted geometric means|94.86||||||90.0|83.86|107.29|||||Natural log transformed AUClast was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUClast|
1709711|NCT00844376|3145762|Superiority or Other||ratio of adjusted geometric means|95.04||||||90.0|84.99|106.27|||||Natural log transformed AUCinf was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUCinf|
1709712|NCT00844376|3145763|Superiority or Other||ratio of adjusted geometric means|95.77||||||90.0|85.82|106.88|||||Natural log transformed AUC48 was analyzed using a mixed effect model with sequence, period and treatment as a fixed effect and subject within sequence as a random effect.|Ratio of adjusted means (test/reference), and 90% CI for ratio--for AUC48; restricted (residual) maximum likelihood (REML) method of estimation.|
1709713|NCT00844194|3145865|Superiority or Other||LSmean|-1.67|||<|0.0001|2-Sided|95.0|-2.3|-1.04|||ANCOVA||||
1709714|NCT00844194|3145865|Superiority or Other||LSmean|-1.49|||<|0.0001|2-Sided|95.0|-1.89|-1.1|||ANCOVA|with last observation carried forward (LOCF)|||
1709715|NCT00843856|3145881|Superiority|||||||0.7|||||||Fisher Exact||||
1709716|NCT00843492|3145944|Superiority or Other||Odds Ratio (OR)|0.3|||<|0.001|2-Sided|95.0|0.15|0.54|||Fisher Exact||||
1709717|NCT00843479|3145945|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1709718|NCT00843479|3145946|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1709719|NCT00843479|3145947|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1709720|NCT00843479|3145948|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1709721|NCT00843479|3145949|Superiority or Other||Mean Difference (Final Values)|1.25||||0.001||95.0|||||Wilcoxon (Mann-Whitney)||||
1709722|NCT00843479|3145950|Superiority or Other||Mean Difference (Final Values)|1.07||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1709723|NCT00843284|3145957|Superiority or Other||Mean Difference (Net)|-4.02|Standard Deviation|2.9|<|0.0001||95.0|-4.24|-3.8|||t-test, 2 sided|One sample t-test.||Change from baseline|
1709724|NCT00843284|3145958|Superiority or Other||Mean Difference (Net)|-4.16|Standard Deviation|2.52|<|0.0001||95.0|-4.35|-3.97|||t-test, 2 sided|One sample t-test||Change from Baseline; observational study|
1709725|NCT00843193|3145973|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.0537|2-Sided|95.0|-0.19|0.0|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 12|
1709726|NCT00843193|3145973|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.4231|2-Sided|95.0|-0.12|0.05|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 8|
1709727|NCT00843193|3145973|Superiority or Other||Mean Difference (Final Values)|0.01||||0.8987|2-Sided|95.0|-0.08|0.09|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 4|
1709728|NCT00843193|3145973|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.7693|2-Sided|95.0|-0.08|0.06|||ANCOVA|||Comparison between GSK679586 10 mg/kg and Placebo at Week 2|
1709729|NCT00843193|3145976|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.4672|2-Sided|95.0|-0.31|0.14|||ANCOVA|||Comparison between GSK679586 120 mg/kg and Placebo at Week 12|
1709730|NCT00843193|3145976|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.6156|2-Sided|95.0|-0.23|0.14|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 8|
1709731|NCT00843193|3145976|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.0193|2-Sided|95.0|-0.34|-0.03|||Mixed Model Repeated Measures analysis|||Comparison between GSK679586 10 mg/kg and Placebo at Week 4|
1709732|NCT00843193|3145976|Superiority or Other||Mean Difference (Final Values)|-0.11||||0.1955|2-Sided|95.0|-0.27|0.06|||ANCOVA|||Comparison between GSK679586 10 mg/kg and Placebo at Week 2|
1709733|NCT00843180|3145977|Superiority or Other||Mean Difference (Final Values)|5.8|Standard Deviation|0.0||0.7|2-Sided|95.0|-9.5|13.2|||t-test, 2 sided|unadjusted|95%CI is dispersion measure||
1709734|NCT00843180|3145978|Superiority or Other||Median Difference (Final Values)|-3.8|Standard Deviation|0.0||0.78|2-Sided|95.0|-31.9|24.3|||t-test, 2 sided||95% CI is dispersion parameter||
1709735|NCT00843180|3145979|Superiority or Other||Mean Difference (Final Values)|-2.38|Standard Deviation|0.0||0.29|2-Sided|95.0|-6.9|2.1||unadjusted|t-test, 2 sided||CI serves as dispersion measure||
1709736|NCT00843180|3145980|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Deviation|0.0||0.8|2-Sided|95.0|-5.4|4.2||unadjusted|t-test, 2 sided||this was a feasibility pilot study CI is descriptor of dispersion|comparison between groups by t-test|
1709737|NCT00843115|3145985|Superiority or Other|||||||0.0078|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"|||
1709738|NCT00843115|3145986|Superiority or Other|||||||0.0131|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"|||
1709739|NCT00843115|3145987|Superiority or Other|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"|||
1709740|NCT00843115|3145988|Superiority or Other|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"|||
1709741|NCT00843115|3145989|Superiority or Other|||||||0.8575|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF"|||
1709742|NCT00843115|3145990|Superiority or Other|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"|||
1709743|NCT00843115|3145991|Superiority or Other|||||||0.1779|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF."|||
1709744|NCT00843115|3145992|Superiority or Other|||||||0.0719|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12"|||
1709745|NCT00843115|3145993|Superiority or Other|||||||1|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12 LOCF."|||
1709746|NCT00843115|3145994|Superiority or Other|||||||0.7963|||||||McNemar|"McNemar's Test for paired proportions tested the difference between the proportion of subjects with Any problem at baseline versus Week 12."|||
1709747|NCT00843115|3145995|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.|||
1709748|NCT00843115|3145996|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.|||
1709749|NCT00843115|3145997|Superiority or Other|||||||0.0229|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero|||
1709750|NCT00843115|3145998|Superiority or Other|||||||0.0152|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.|||
1709751|NCT00843115|3145999|Superiority or Other|||||||0.0225|||||||Correlation coefficient||||
1709752|NCT00843115|3146000|Superiority or Other|||||||0.0713|||||||correlation coefficient||||
1709753|NCT00843115|3146001|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero|||
1709754|NCT00843115|3146002|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.|||
1709755|NCT00843115|3146003|Superiority or Other||||||<|0.0001|||||||correlation coefficient|p-value tests whether Pearson Product Correlation Coefficient is significantly different from zero|||
1709756|NCT00843115|3146004|Superiority or Other||||||<|0.0001|||||||correlation coefficient|P value tests whether Pearson Product Correlation Coefficient is significantly different from zero|||
1709757|NCT00843115|3146005|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero||Change from baseline in total score at Week 12 Last Observation Carried Forward|
1709758|NCT00843115|3146006|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|One sample t-test, testing whether mean change from baseline is significantly different from zero.||Change from baseline in total score at Week 12|
1709759|NCT00843115|3146007|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709760|NCT00843115|3146008|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709761|NCT00843115|3146009|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate @ 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709762|NCT00843115|3146010|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709763|NCT00843115|3146011|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709764|NCT00843115|3146012|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709765|NCT00843115|3146013|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709766|NCT00843115|3146014|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709767|NCT00843115|3146015|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709768|NCT00843115|3146016|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709769|NCT00843115|3146017|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709770|NCT00843115|3146018|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709771|NCT00843115|3146019|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709772|NCT00843115|3146020|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709773|NCT00843115|3146021|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709774|NCT00843115|3146022|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709795|NCT00842153|3146178|Superiority or Other||||||<|0.0001||||||P-value for Week 2|Chi-squared||||
1709775|NCT00843115|3146023|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709776|NCT00843115|3146024|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709777|NCT00843115|3146025|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5|
1709778|NCT00843115|3146026|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.|
1709779|NCT00843115|3146027|Superiority or Other||||||<|0.0001|||||||Binomial test of proportions|Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05||null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.|
1709780|NCT00843024|3146047|Superiority or Other||Mean Difference (Final Values)|0.13||||0.003|2-Sided|95.0|0.05|0.22||Adjusted for multiplicity according to the fixed-sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 85 mg/Naproxen 500 mg minus placebo||
1709781|NCT00843024|3146047|Superiority or Other||Mean Difference (Final Values)|0.16||||0.003|2-Sided|95.0|0.07|0.26||Adjusted for multiplicity according to the fixed-sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 30 mg/Naproxen180 mg minus placebo||
1709782|NCT00843024|3146047|Superiority or Other||Mean Difference (Final Values)|0.2||||0.003|2-Sided|95.0|0.09|0.3||Adjusted for multiplicity according to the fixed sequence testing strategy|Cochran-Mantel-Haenszel||Sumatriptan 10 mg/Naproxen 60 mg minus placebo||
1709783|NCT00842829|3146073|Non-Inferiority or Equivalence|Non-inferiority was established if the upper limit of the 90% CI was <8%.|Mean Difference (Net)|-6.3|||||1-Sided|95.0||1.4|||||The upper bound of the 2-sided 90% confidence interval is equivalent to the upper bound of the 1-sided 95% confidence interval.|Treatment comparison difference (100 mcg - 200 mcg)|
1709784|NCT00842712|3146080|Superiority or Other||Hazard Ratio (HR)|0.813||||0.2648|2-Sided|95.0|0.564|1.171|||Log Rank||||
1709785|NCT00842712|3146081|Superiority or Other||Hazard Ratio (HR)|0.909||||0.5912|2-Sided|95.0|0.642|1.286|||Log Rank||||
1709786|NCT00842712|3146082|Superiority or Other||Hazard Ratio (HR)|0.718||||0.0845|2-Sided|95.0|0.492|1.048|||Log Rank|||PFS Time: Independent read|
1709787|NCT00842530|3146092|Other|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|34.9|||||2-Sided|95.0|6.7|54.3||||||Vaccine efficacy: Day 0 up to end of Active Phase|
1709788|NCT00842530|3146092|Other|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|33.4|||||2-Sided|95.0|4.1|53.5||||||Vaccine efficacy: 28 days Post-Inj. 1 up to end of Active Phase|
1709789|NCT00842530|3146098|Superiority|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|35.3|||||2-Sided|95.0|3.3|56.5||||||Vaccine efficacy: 28 days Post-Inj. 2 up to end of Active Phase|
1709790|NCT00842530|3146098|Superiority|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|41.5|||||2-Sided|95.0|-38.4|74.9||||||Vaccine efficacy:- 28 days Post-Inj. 2 up to Inj. 3|
1709791|NCT00842530|3146099|Other|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|50.3|||||2-Sided|95.0|-585.0|96.4||||||Vaccine efficacy of against severe VCD (WHO 1999)|
1709792|NCT00842530|3146099|Other|The statistical methodology was based on the use of the two-sided 95% CI of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups. The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|75.2|||||2-Sided|95.0|-377.0|99.6||||||Vaccine efficacy against severe VCD (IDMC)|
1709793|NCT00842530|3146100|Superiority|The vaccine efficacy of the CYD dengue vaccine against severe VCD cases was considered significant only if the lower bound of its 95% CI was greater than 0%.|Vaccine efficacy (%)|30.2|||||2-Sided|95.0|-13.4|56.6||||||Vaccine efficacy of CYD dengue vaccine: The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups.|
1709798|NCT00841815|3146192|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.11||||||90.0|95.08|105.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709799|NCT00841815|3146193|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.94||||||90.0|95.6|106.58|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709800|NCT00841815|3146194|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|96.43||||||90.0|91.4|101.74|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709801|NCT00841698|3146213|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.83||||||90.0|89.96|99.96|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709802|NCT00841698|3146214|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.46||||||90.0|90.22|98.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709803|NCT00841698|3146215|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|97.34||||||90.0|91.67|103.35|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709804|NCT00841659|3146221|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|94.29||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.||
1709805|NCT00841659|3146222|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|93.58||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.||
1709806|NCT00841659|3146223|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of LS Means x 100|99.96||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.||
1709807|NCT00841542|3146230|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.22||||||90.0|93.87|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709808|NCT00841542|3146231|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.86||||||90.0|93.38|104.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709809|NCT00841542|3146232|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.19||||||90.0|94.2|102.34|||||Bioequivalence is established when 90% Confidence Interval falls withing 80 - 125||
1709810|NCT00841412|3146233|Superiority or Other||Odds Ratio (OR)|0.76|||<|0.05|2-Sided|95.0|0.59|0.96|||Mixed Models Analysis||The above results are for just one of multiple feeding assistance care process measures: proportion of meals during which residents received assistance to eat baseline to post intervention.||
1709811|NCT00841321|3146234|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.6||0.4||95.0|-1.3|0.8|||ANCOVA|||Community Integration Questionnaire|
1709812|NCT00841321|3146234|Superiority or Other||Mean Difference (Final Values)|0.8|Standard Error of the Mean|2.0||0.7||95.0|-3.2|4.8|||ANCOVA||Positive values indicate a beneficial effect from Ginkgo.|Multiple Sclerosis Neuropsychological Questionnaire|
1709813|NCT00841321|3146234|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|2.7||0.4|2-Sided|95.0|-5.7|4.7|||ANCOVA||Positive values indicate a beneficial effect from Ginkgo.|Perceived Deficits Questionnaire|
1709814|NCT00841321|3146235|Superiority or Other|||||||0.19|||||||MANCOVA|MANCOVA||MANCOVA for all four cognitive tests at exit adjusting for baseline. Individual ANOVAs were to follow if the multivariate test was significant.|
1709815|NCT00841321|3146235|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.15||0.5||95.0|-0.3|0.3||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||CVLT-II Delayed Recall Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.|
1709816|NCT00841321|3146235|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.1||0.5|2-Sided|95.0|-0.2|0.3||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||COWAT Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.|
1709817|NCT00841321|3146235|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.2||0.007|2-Sided|95.0|-0.9|-0.1||Not adjusted for multiple comparison. Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||Stroop Exit Z-score least square means difference adjusted for baseline.Positive values indicate a beneficial effect from treatment with Ginkgo.|
1709818|NCT00841321|3146235|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.15||0.1|2-Sided|95.0|-0.5|0.1||Nominal value. Per protocol univariate tests would only be considered significant in the multivariate test was significant.|ANCOVA|||PASAT Exit Z-score least square means difference adjusted for baseline. Positive values indicate a beneficial effect from treatment with Ginkgo.|
1709819|NCT00841204|3146239|Other|||||||0.12|||||||Regression, Linear||||
1709822|NCT00841204|3146242|Other|||||||0.386|||||||Wilcoxon (Mann-Whitney)||||
1709823|NCT00841204|3146243|Other|||||||0.0056|||||||Wilcoxon (Mann-Whitney)||||
1709824|NCT00840996|3146257|Superiority or Other||Mean Difference (Final Values)|4.6||||0.04|2-Sided|95.0|0.3|8.9|||Regression, Logistic||||
1709825|NCT00840996|3146258|Superiority or Other||Mean Difference (Final Values)|6.2||||0.002|2-Sided|95.0|2.3|10.0|||Regression, Linear||||
1709826|NCT00840996|3146259|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.15|2-Sided|95.0|-2.4|0.4|||Regression, Linear||||
1709827|NCT00840996|3146260|Superiority or Other||Odds Ratio (OR)|1.04||||0.44|2-Sided|95.0|0.94|1.14|||Regression, Logistic|||Vomiting - POD 2|
1709828|NCT00840996|3146260|Superiority or Other||Odds Ratio (OR)|0.91||||0.31|2-Sided|95.0|0.77|1.09|||Regression, Logistic|||Nausea - POD 2|
1709829|NCT00840996|3146261|Superiority or Other||Odds Ratio (OR)|0.91||||0.049|2-Sided|95.0|0.84|1.0|||Regression, Logistic||||
1709830|NCT00840996|3146262|Non-Inferiority or Equivalence|Non-inferiority margin: ratio of the geometric means not more than 1.3 greater (mean mg IV morphine equivalent not more than 30% greater ) than that of the other group|the ratio of the geometric means|0.8||||0.011|2-Sided|95.0|0.65|1.21||Noninferiority hypotheses were evaluated against a one-sided significance criterion of 0.025 [adjusting for testing in both directions: lidocaine vs. control and vs. control vs. lidocaine ]|Regression, Linear|Log-linear regression model was used; 0.1 mg added before taking the logarithm to accommodate the 2 patients who received 0 mg opioids.||Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .|
1709831|NCT00840996|3146263|Superiority or Other||Mean Difference (Final Values)|-0.8|||<|0.001|2-Sided|97.5|-1.23|-0.4||Test for superiority adjusted for 2 primary comparisons (2 outcomes)|Mixed Models Analysis|Llinear mixed-effects accounts for correlation exhibited by the repeated pain measurements on a given patient (spatial power correlation structure).||Postoperative analgesia was characterized using both pain scores and opioid consumption .We considered one of the groups to be better than the other on postoperative pain control with superiority on either outcome, in the presence of noninferiority on both outcomes. Thus, our primary hypothesis was assessed in a joint hypothesis testing framework .|
1709832|NCT00840879|3146264|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.76||||||90.0|93.31|102.42|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709833|NCT00840879|3146265|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|96.34||||||90.0|91.82|101.07|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709834|NCT00840879|3146266|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.15||||||90.0|90.96|105.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709835|NCT00840866|3146267|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.8||||||90.0|98.5|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1709836|NCT00840866|3146268|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.9||||||90.0|98.6|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1709837|NCT00840866|3146269|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|104.0||||||90.0|99.0|109.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1709838|NCT00840840|3146270|Non-Inferiority or Equivalence|ANOVA|Test/Reference Ratio of the mean x 100|100.17||||||90.0|91.95|109.13|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709839|NCT00840840|3146271|Non-Inferiority or Equivalence|ANOVA|Test/Reference Ratio of the mean x 100|101.48||||||90.0|94.73|108.71|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709840|NCT00840840|3146272|Non-Inferiority or Equivalence|ANOVA|Test/Reference Ratio of the mean x 100|99.68||||||90.0|92.41|107.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709841|NCT00840840|3146273|Non-Inferiority or Equivalence|ANOVA|Test/Reference Ratio of the mean x 100|102.94||||||90.0|101.08|104.83|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709842|NCT00840840|3146274|Non-Inferiority or Equivalence|ANOVA|Test/Reference Ratio of the mean x 100|103.05||||||90.0|101.25|104.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709843|NCT00840840|3146275|Non-Inferiority or Equivalence|ANOVA|Test/Reference Ratio of the mean x 100|101.45||||||90.0|97.71|105.33|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709861|NCT00840281|3146315|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|94.9|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%||
1709844|NCT00840658|3146286|Superiority|||||||0.013||||||P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).|Mixed Models Analysis|||Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the mean score IRI (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in the IRI but the control group will not.)|We used gamma regression for correlated data via GEE, with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final gamma regression models included the following main effects: Group, Visit, and Visit*Group interaction, with our primary interest in the Visit*Group interaction, as a significant p-value would be indicative of an intervention effect.
1709845|NCT00840658|3146287|Superiority|||||||0.036||||||P-value is for the Ciudad Juarez site and it corresponds to the interaction between group (Intervention vs. Control) and study visit (12-months vs. baseline).|Mixed Models Analysis|||Alternative hypothesis: There is a difference between the intervention and the control group with respect to the change in the odds of higher receptive needle sharing. (i.e., The interaction between study visit (baseline, 4-, 8-, and 12-months) and intervention group will be significant at 0.05 significance level. Over time, the intervention group will experience a significant decline in receptive needle sharing but the control group will not.)|To examine the receptive needle sharing outcome, we used ordinal logistic regression for correlated data via GEE with the correlation matrix estimated empirically from the data. The final analyses were stratified by site. The final ordinal logistic regression models included the following main effects: Group, Visit, and Visit*Group interaction, with our primary interest in the Visit*Group interaction, as a significant p-value would be indicative of an intervention effect.
1709846|NCT00840632|3146290|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.1||||||90.0|98.12|102.12|||||Informational Purposes Only||
1709847|NCT00840632|3146291|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.24||||||90.0|98.11|102.43|||||Informational Purposes Only||
1709848|NCT00840632|3146292|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|102.93||||||90.0|99.8|106.15|||||Informational Purposes Only||
1709849|NCT00840632|3146293|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.17||||||90.0|92.71|106.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709850|NCT00840632|3146294|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|100.35||||||90.0|92.08|109.36|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709851|NCT00840632|3146295|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|93.26||||||90.0|83.39|104.31|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709852|NCT00840476|3146296|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|104.33||||||90.0|99.16|109.76|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709853|NCT00840476|3146297|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|105.14||||||90.0|100.27|110.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709854|NCT00840476|3146298|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.26||||||90.0|93.12|107.95|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709855|NCT00840411|3146307|Non-Inferiority or Equivalence|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|87.2||||||90.0|81.0|93.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709856|NCT00840411|3146308|Non-Inferiority or Equivalence|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|86.5||||||90.0|80.1|93.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709857|NCT00840411|3146309|Non-Inferiority or Equivalence|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.0||||||90.0|93.3|107.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709858|NCT00840294|3146312|Superiority or Other|||||||0.33|||||||t-test, 2 sided||||
1709859|NCT00840281|3146313|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.7|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1709860|NCT00840281|3146314|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.6|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%||
1710433|NCT00833105|3147414|Superiority or Other|||||||0.343|||||||Mixed Models Analysis|Random subject effect|||
1709862|NCT00840216|3146316|Non-Inferiority or Equivalence|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|93.0||||||90.0|||||||Bioequivalence is established when ratio of the mean falls within 80-125.||
1709863|NCT00840216|3146317|Non-Inferiority or Equivalence|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|92.7||||||90.0|||||||Bioequivalence is established when ratio of the mean falls within 80-125.||
1709864|NCT00840216|3146318|Non-Inferiority or Equivalence|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|106.9||||||90.0|||||||Bioequivalence is established when the ratio of the mean falls within 80-125.||
1709865|NCT00840203|3146319|Non-Inferiority or Equivalence|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|95.6||||||90.0|86.1|106.0|||||Metabolite results presented for informational purposes only.||
1709866|NCT00840203|3146320|Non-Inferiority or Equivalence|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.6||||||90.0|86.7|110.0|||||Metabolite results presented for informational purposes only.||
1709867|NCT00840203|3146321|Non-Inferiority or Equivalence|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|98.3||||||90.0|91.5|106.0|||||Metabolite results presented for informational purposes only.||
1709868|NCT00840203|3146322|Non-Inferiority or Equivalence|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|94.0||||||90.0|83.0|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709869|NCT00840203|3146323|Non-Inferiority or Equivalence|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.3||||||90.0|82.8|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709870|NCT00840203|3146324|Non-Inferiority or Equivalence|Using the General Linear Model (GLM) procedure of SAS the bioequivalence of the test and reference products will be evaluated using average bioequivalence methodology for non-replicate crossover study design.|Geometric Test/Ref Ratio x 100|97.6||||||90.0|88.6|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709871|NCT00840099|3146330|Non-Inferiority or Equivalence|ANOVA|Test/Reference Ratio of the mean x 100|104.06||||||90.0|95.85|112.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709872|NCT00840099|3146331|Non-Inferiority or Equivalence|ANOVA|Ratio of the mean|104.15||||||90.0|96.35|112.58|||||Bioequivalence is established when 80% Confidence Interval falls within 80 - 125||
1709873|NCT00840099|3146332|Non-Inferiority or Equivalence|ANOVA|Test/Reference Ratio of the Mean x 100|100.47||||||90.0|93.28|108.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709874|NCT00840099|3146333|Non-Inferiority or Equivalence|ANOVA|Test/Reference Ratio of the mean x 100|102.75||||||90.0|100.62|104.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709875|NCT00840099|3146334|Non-Inferiority or Equivalence|ANOVA|Test/Reference Ratio of the mean x 100|102.79||||||90.0|100.69|104.94|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709876|NCT00840099|3146335|Non-Inferiority or Equivalence|ANOVA|Test/Reference Ratio of Means x 100|100.91||||||90.0|95.82|106.26|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709877|NCT00840073|3146338|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Least Squares Means|103.34||||||90.0|100.84|105.92|||||Informational Purposes Only||
1709878|NCT00840073|3146339|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.76||||||90.0|100.08|107.57|||||Informational Purposes Only||
1709879|NCT00840073|3146340|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|102.37||||||90.0|97.34|107.65|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709880|NCT00840073|3146341|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|103.81||||||90.0|96.72|111.41|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709881|NCT00840073|3146342|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.0||||||90.0|85.13|108.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709882|NCT00839982|3146364|Superiority|||||||0.03||||||Hypothesis: achieving CR provides an overall longer survival.|Chi-squared||||
1709883|NCT00839930|3146369|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|96.64||||||90.0|92.13|101.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709884|NCT00839930|3146370|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be performed on the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|96.14||||||90.0|91.04|101.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709885|NCT00839930|3146371|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be performed on the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|93.39||||||90.0|87.33|99.86|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710434|NCT00833105|3147415|Superiority or Other|||||||0.459|||||||Mixed Models Analysis|Random subject effect|||
1709886|NCT00839527|3146412|Non-Inferiority or Equivalence|The p-value is from a one-sided t-test testing at the 0.025 level of significance whether or not the difference of least square means (albiglutide - pioglitazone) is less than or equal to the pre-specified non-inferiority margin of 0.3%.|Mean Difference (Net)|0.25||||0.2685|2-Sided|95.0|0.1|0.4|||t-test, 1 sided||||
1709887|NCT00839527|3146412|Superiority or Other||Mean Difference (Net)|-0.87|||<|0.0001|2-Sided|95.0|-1.07|-0.68|||ANCOVA||||
1709888|NCT00839423|3146415|Superiority or Other||Difference %|22.33||||0.001|2-Sided|95.0|9.39|35.28||A nominal p-value is provided.|Fisher Exact||||
1709889|NCT00839423|3146415|Superiority or Other||Difference %|22.41||||0.001|2-Sided|95.0|9.74|35.07||A nominal p-value is provided.|Fisher Exact||||
1709890|NCT00839423|3146416|Superiority or Other||Difference %|23.34||||0.001|2-Sided|95.0|10.05|36.43||A nominal p-value is provided.|Fisher Exact||||
1709891|NCT00839423|3146416|Superiority or Other||Difference %|21.9||||0.002|2-Sided|95.0|8.89|34.92||A nominal p-value is provided.|Fisher Exact||||
1709892|NCT00839423|3146417|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.16||0.0003|2-Sided|95.0|-0.92|-0.27||A nominal p-value is provided.|ANCOVA||||
1709893|NCT00839423|3146417|Superiority or Other||Mean Difference (Final Values)|-0.58|Standard Error of the Mean|0.16||0.0003|2-Sided|95.0|-0.9|-0.27||A nominal p-value is provided.|ANCOVA||||
1709894|NCT00839423|3146418|Superiority or Other||Mean Difference (Final Values)|-0.95|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|-1.34|-0.56||A nominal p-value is provided.|ANCOVA||||
1709895|NCT00839423|3146418|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.19|<|0.0001|2-Sided|95.0|-1.28|-0.52||A nominal p-value is provided.|ANCOVA||||
1709896|NCT00839423|3146419|Superiority or Other||Mean Difference (Final Values)|-3.0|Standard Error of the Mean|1.02||0.0034|2-Sided|95.0|-5.01|-1.0||A nominal p-value is provided.|ANCOVA||||
1709897|NCT00839423|3146419|Superiority or Other||Mean Difference (Final Values)|-3.3|Standard Error of the Mean|1.0||0.0011|2-Sided|95.0|-5.27|-1.33||A nominal p-value is provided.|ANCOVA||||
1709898|NCT00839423|3146420|Superiority or Other||Mean Difference (Final Values)|-5.33|Standard Error of the Mean|1.25|<|0.0001|2-Sided|95.0|-7.79|-2.88||A nominal p-value is provided.|ANCOVA||||
1709899|NCT00839423|3146420|Superiority or Other||Mean Difference (Final Values)|-5.28|Standard Error of the Mean|1.22|<|0.0001|2-Sided|95.0|-7.69|-2.88||A nominal p-value is provided.|ANCOVA||||
1709900|NCT00839423|3146421|Superiority or Other||Mean Difference (Final Values)|0.54|Standard Error of the Mean|0.67||0.4142|2-Sided|95.0|-0.77|1.85||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA||||
1709901|NCT00839423|3146421|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.67||0.7489|2-Sided|95.0|-1.54|1.11||The hierarchical procedure meant that the above hypothesis was not tested since significance was not achieved for 10 mg at Week 1. A nominal p-value is provided.|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 5 mg Vortioxetine and placebo at Week 1."|
1709902|NCT00839423|3146421|Superiority or Other||Mean Difference (Final Values)|-0.82|Standard Error of the Mean|0.69||0.2377|2-Sided|95.0|-2.17|0.54||"The hierarchical procedure meant that the above hypothesis was tested at a 5% significance level since significance was achieved for both 10 and 5 mg at Week 6.~Since p-value was >0.05, hierarchically testing stopped here."|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 10 mg Vortioxetine and placebo at Week 1."|
1709903|NCT00839423|3146422|Superiority or Other||Mean Difference (Final Values)|-6.42|Standard Error of the Mean|1.38|<|0.0001|2-Sided|95.0|-9.13|-3.72||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA||||
1709904|NCT00839423|3146422|Superiority or Other||Mean Difference (Final Values)|-5.9|Standard Error of the Mean|1.39|<|0.0001|2-Sided|95.0|-8.64|-3.17||"The hierarchical hypothesis testing meant that comparison of 5 mg to placebo was performed at a 5% significance level since significance was achieved for the primary comparison of 10 mg to placebo.~Since p-value <0.05, hierarchically testing contd."|ANCOVA|||"The statistical model was ANCOVA of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 5 mg Vortioxetine and placebo at Week 6."|
1709905|NCT00839423|3146422|Superiority or Other||Mean Difference (Final Values)|-5.7|Standard Error of the Mean|1.42|<|0.0001|2-Sided|95.0|-8.49|-2.91||"A hierarchical hypothesis testing procedure was used. The comparison of 10 mg to placebo was primary.~Since p-value was <0.05, hierarchically testing continued."|ANCOVA|||"The statistical model was an analysis of covariance (ANCOVA) of the change from baseline in MADRS total score (FAS, LOCF) with treatment and centre as fixed factors and the baseline MADRS score as a covariate.~Null hypothesis: No difference between 10 mg Vortioxetine and placebo at Week 6.~With 96 patients in each treatment arm and a standard deviation of 9 points, the power to detect a true effect of 3.7 points on the MADRS total score at Week 6 will be 80%."|
1709906|NCT00839332|3146434|Superiority or Other||Bayesian Posterior Probability|0.333|||||2-Sided||||||||Inference about survival was made using a Bayesian posterior probability. The combination treatment would have been considered superior to gemcitabine alone if the posterior probability of superiority exceeded 0.8.||
1709907|NCT00839319|3146439|Superiority or Other||||||<|0.05|||||||ANOVA|Correlations between serum hormone levels and IT hormones, and between IT hormones were performed on 23 subjects in 4 groups using Spearmen technique.|||
1709908|NCT00839098|3146482|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1709909|NCT00839098|3146483|Superiority or Other||||||>|0.05||||||P values below 0.05 were considered statistically significant in this study.|Wilcoxon (Mann-Whitney)||||
1709910|NCT00839098|3146484|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1709911|NCT00839098|3146485|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1709912|NCT00839098|3146486|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)||||
1709913|NCT00839098|3146487|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1709914|NCT00839098|3146488|Superiority or Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1709915|NCT00839072|3146492|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUC∞ is between 80% and 125%.|Ratio of the mean|80.05|||||2-Sided|90.0|70.67|90.68|||||Trazodone Contramid® OAD/Desyrel®||
1709916|NCT00839072|3146493|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter AUCT is between 80% and 125%.|Ratio of the mean|78.55|||||2-Sided|90.0|69.7|88.51|||||Trazodone Contramid® OAD/Desyrel®||
1709917|NCT00839072|3146494|Non-Inferiority or Equivalence|Bioequivalence is established when the ratio of geometric Least Squares means (LS means) and confidence interval calculated from the exponential of the difference between the Test and Reference product for the ln-transformed parameter Cmax does not exceed 125%.|Ratio of the mean|59.66|||||2-Sided|90.0|50.99|69.81|||||Trazodone Contramid® OAD/Desyrel®||
1709918|NCT00838916|3146509|Superiority or Other|||||||0.1463||||||p-value is for superiority testing of albiglutide versus insulin glargine|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide – insulin glargine) is equal to zero.|||
1709919|NCT00838916|3146509|Non-Inferiority or Equivalence|To test whether the difference of least square means (albiglutide - insulin glargine) is equal to the pre-specified non-inferiority margin of 0.3%||||||0.0086||||||p-value is for non-inferiority testing of albiglutide versus insulin glargine|t-test, 1 sided||||
1709920|NCT00838916|3146509|Superiority or Other||Mean Difference (Net)|0.11|||||2-Sided|95.0|-0.04|0.27|||||||
1709921|NCT00838903|3146518|Superiority or Other|||||||0.0033||||||The p-value is for superiority testing of albiglutide versus glimepiride at 0.025 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide - glimepiride) is equal to zero.|||
1709922|NCT00838903|3146518|Superiority or Other|||||||0.0001||||||The p-value is for superiority testing of albiglutide versus sitagliptin at 0.025 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide – sitagliptin) is equal to zero.|||
1709923|NCT00838903|3146518|Non-Inferiority or Equivalence|To test whether the difference of least square means (albiglutide - glimepiride) is equal to the pre-specified non-inferiority margin of 0.3%.|||||<|0.0001||||||The p-value is for non-inferiority testing of albiglutide versus glimepiride at 0.0125 level.|t-test, 1 sided||||
1709924|NCT00838903|3146518|Non-Inferiority or Equivalence|To test whether the difference of least square means (albiglutide - sitagliptin) is equal to the pre-specified non-inferiority margin of 0.3%.|||||<|0.0001||||||The p-value is for non-inferiority testing of albiglutide versus sitagliptin at 0.0125 level.|t-test, 1 sided||||
1709925|NCT00838903|3146518|Superiority or Other||||||<|0.0001||||||The p-value is for superiority testing of albiglutide over placebo at 0.05 level.|t-test, 2 sided|The p-value is from a two-sided t-test to test whether the difference of least square means (albiglutide – placebo) is equal to zero|||
1709926|NCT00838903|3146518|Superiority or Other||Mean Difference (Net)|-0.27|||<||2-Sided|95.0|-0.45|-0.09|||||||
1709927|NCT00838903|3146518|Superiority or Other||Mean Difference (Net)|-0.35|||<||2-Sided|95.0|-0.53|-0.17|||||||
1709928|NCT00838903|3146518|Superiority or Other||Mean Difference (Net)|-0.91|||<||2-Sided|95.0|-1.16|-0.65|||||||
1709929|NCT00838682|3146521|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1709930|NCT00838682|3146522|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1709931|NCT00838682|3146523|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1709932|NCT00838682|3146524|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1709933|NCT00838682|3146525|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1709934|NCT00838682|3146526|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1709935|NCT00838630|3146527|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|95.7||||||90.0|91.52|100.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709936|NCT00838630|3146528|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be performed for log-transformed AUC0-t, AUC0-inf, and Cmax parameters.|Geometric Test/Ref Ratio x 100|94.37||||||90.0|90.47|98.43|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709937|NCT00838630|3146529|Non-Inferiority or Equivalence|Analysis of Variance (ANOVA) will be performed for the log-transformed AUC0-t, AUC0-inf and Cmax parameters.|Geometric Test/Ref Ratio x 100|98.27||||||90.0|92.32|104.61|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709938|NCT00838513|3146559|Superiority or Other||Percent of platelet count normalization|90.0|||||2-Sided|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years|
1709939|NCT00838513|3146560|Superiority or Other||LS mean change from baseline|-3.68||||0.7307|2-Sided|95.0|-25.15|17.79|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709940|NCT00838513|3146561|Superiority or Other||Median Difference (Final Values)|-0.29|||<|0.0001|2-Sided||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709941|NCT00838513|3146562|Superiority or Other||Percent of complete TMA response|55.0|||||2-Sided|95.0|32.0|77.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709942|NCT00838513|3146563|Superiority or Other||Percent of hematologic normalization|90.0|||||2-Sided|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1710435|NCT00833105|3147416|Superiority or Other|||||||0.299|||||||Mixed Models Analysis|Random subject effect|||
1713858|NCT00791258|3153450|Superiority or Other||Percentage|75.8|||||2-Sided|95.0|73.0|78.5|||||||
1709943|NCT00838513|3146564|Superiority or Other||Percent of TMA event-free responders|95.0|||||2-Sided|95.0|75.0|100.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709944|NCT00838513|3146565|Superiority or Other||Percent of platelet count normalization|90.0|||||2-Sided|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years|
1709945|NCT00838513|3146566|Superiority or Other||LS mean change from baseline|6.75||||0.5423|2-Sided|95.0|-15.73|29.23|||ANOVA|Change from baseline were analyzed using a repeated measurement ANOVA model with time and baseline as fixed effects and subject as a random effect.||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years|
1709946|NCT00838513|3146567|Superiority or Other||Median Difference (Final Values)|-0.29|||<|0.0001|2-Sided||||||Wilcoxon (Mann-Whitney)|||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709947|NCT00838513|3146568|Superiority or Other||Percent of complete TMA response|25.0|||||2-Sided|95.0|9.0|49.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709948|NCT00838513|3146569|Superiority or Other||Percent of hematologic normalization|90.0|||||2-Sided|95.0|68.0|99.0||||||All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS.|
1709949|NCT00838513|3146570|Superiority or Other||Percent of TMA event-free responders|80.0|||||2-Sided|95.0|56.0|94.0||||||"With a total of 20 patients enrolled between both protocols and, assuming that the true expected probability of TMA Event-Free for eculizumab-treated patients is 40%, then the study had 93.5% power to detect a statistically significant difference. Up to approximately 30 patients were to be enrolled.~All analyses were based on the pooled data from the two protocols: C08-003A (adult) and C08-003B (adolescent), a similar protocol, for patients <18 years with aHUS."|
1709950|NCT00838279|3146572|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.94||||||90.0|97.4|102.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709951|NCT00838279|3146573|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.78||||||90.0|99.09|104.55|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709952|NCT00838279|3146574|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.31||||||90.0|97.82|102.85|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709953|NCT00838136|3146585|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.76||||||90.0|98.6|102.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709954|NCT00838136|3146586|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.87||||||90.0|99.18|104.63|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709955|NCT00838136|3146587|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.23||||||90.0|99.88|102.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709956|NCT00837577|3146661|Superiority or Other||Least squares mean difference|-22.5|Standard Error of the Mean|3.8|<|0.001|2-Sided|95.0|-30.0|-15.0||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.|||
1709957|NCT00837577|3146662|Superiority or Other||Least squares mean difference|-51.3|Standard Error of the Mean|5.6|<|0.001|2-Sided|95.0|-62.3|-40.2||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.|||
1709958|NCT00837577|3146663|Superiority or Other||Least squares mean difference|-0.92|Standard Error of the Mean|0.09|<|0.001|2-Sided|95.0|-1.09|-0.75||Adjusted for other prior antihyperglycemic medications (absence, presence).|Longitudinal data analysis (LDA)|LDA model included both baseline and post-baseline measurements as response variables. P-value calculated using least squares mean.|||
1709959|NCT00837486|3146669|Superiority or Other||||||=|0||||||"one-sided P-value~per protocol responder rates: Active Group = 20.0%, Control Group = 14.3%"|Fisher Exact|||The study originally required a sample size of 208 subjects in order to have 90% power to detect a statistically significant difference between the responder rate of the active and control groups. With this 30-subject cohort, and only 29 subjects completing the blinded-treatment phase per protocol, the comparison of response rates was not adequately powered. The P-value is presented only to describe the outcomes of the two groups.|
1709960|NCT00837434|3146687|Superiority or Other|||||||0.3|||||||ANCOVA|P-value for testing treatment effect uses week 12 CD27+ switched memory as the outcome variable and adjusts for baseline CD27+ switched memory||Null Hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 does not differ between individuals treated with etanercept and those treated with adalimumab after adjusting for baseline CD27+ switched memory cells. Alt. hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 in individuals treated with etanercept is lower than in those treated with adalimumab after adjusting for baseline CD27+ switched memory cells.|
1710055|NCT00835588|3146911|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.3||||||90.0|93.4|101.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709961|NCT00836901|3146730|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.08||||||90.0|87.19|101.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709962|NCT00836901|3146731|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.44||||||90.0|87.83|101.54|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709963|NCT00836901|3146732|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|94.59||||||90.0|85.64|104.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709964|NCT00836901|3146733|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|97.64||||||90.0|96.12|99.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709965|NCT00836901|3146734|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|99.28||||||90.0|97.09|101.53|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709966|NCT00836901|3146735|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|97.7||||||90.0|93.19|102.43|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1709967|NCT00836810|3146741|Superiority|||||||0.88||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709968|NCT00836810|3146741|Superiority|||||||0.001||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709969|NCT00836810|3146741|Superiority|||||||0.003||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709970|NCT00836810|3146742|Superiority|||||||0.51||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709971|NCT00836810|3146742|Superiority|||||||0.002||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709972|NCT00836810|3146742|Superiority|||||||0.022||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709973|NCT00836810|3146743|Superiority|||||||0.57||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709974|NCT00836810|3146743|Superiority|||||||0.002||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709975|NCT00836810|3146743|Superiority|||||||0.007||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709976|NCT00836810|3146744|Superiority|||||||0.044||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709977|NCT00836810|3146744|Superiority|||||||0.0906||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709978|NCT00836810|3146744|Superiority or Other|||||||0.023||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709979|NCT00836810|3146745|Superiority||||||<|0.01||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709980|NCT00836810|3146745|Superiority||||||<|0.01||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709981|NCT00836810|3146745|Superiority||||||<|0.001|||||||t-test, 2 sided|A priori statistical significance set at P<0.05|||
1709982|NCT00836810|3146746|Superiority or Other||||||<|0.01||||||A priori statistical significance set as P<0.05|t-test, 2 sided||||
1709983|NCT00836810|3146746|Superiority||||||<|0.001||||||A priori statistical significance set at P<0.05|t-test, 2 sided||||
1709984|NCT00836810|3146746|Superiority||||||<|0.001||||||A priory test for statistical significance was P<0.05|t-test, 2 sided||||
1709985|NCT00836758|3146748|Superiority or Other|||||||0.007|||||||Wilcoxon (Mann-Whitney)||||
1709986|NCT00836719|3146753|Superiority or Other||Mean Difference (Final Values)|10.0|||<|0.01||95.0|3.4|16.2|||Mixed Models Analysis|Anisotropic power spatial covariance matrix with terms for time and the registered voxel. Kenward Rogers approx. for degrees of freedom.|Dependent variable: NAA. Main effect: visit. Covariates Cre, %GM, %WM, %CSF and %lesion in the voxel.|N-Acetylaspartate acid (NAA) levels were measured at baseline and exit (6 months). Voxels with less than 30% error in NAA and Creatine (Cre) were used.NAA, Cre and Proton Density were log transformed.|
1709987|NCT00836706|3146755|Non-Inferiority or Equivalence|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|88.4|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709988|NCT00836706|3146756|Non-Inferiority or Equivalence|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|88.7|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709989|NCT00836706|3146757|Non-Inferiority or Equivalence|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|101.0||||||90.0|85.2|120.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1709990|NCT00836693|3146758|Superiority or Other||||||<|0.0001||||||p-value is for Global Assessment Question GAQ2.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|Wilcoxon (Mann-Whitney)|||Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.|
1709991|NCT00836693|3146759|Superiority or Other||||||<|0.0001||||||p-value is for Global Assessment Questions GAQ1. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|Wilcoxon (Mann-Whitney)|||Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.|
1710206|NCT00834106|3147185|Superiority or Other||Vaccine efficacy|91.8|||||2-Sided|95.0|79.8|97.4|||||Vaccine efficacy = 100 * [1 - (incidence rate with V501 / incidence rate with placebo)].||
1709992|NCT00836693|3146760|Superiority or Other||Mean Difference (Final Values)|23.5|Standard Error of the Mean|4.96|<|0.001|2-Sided|95.0|13.7|33.2||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.|
1709993|NCT00836693|3146761|Superiority or Other||Mean Difference (Final Values)|24.5|Standard Error of the Mean|4.99|<|0.001|2-Sided|95.0|14.6|34.3||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.|
1709994|NCT00836693|3146762|Superiority or Other||Mean Difference (Final Values)|6.3|Standard Error of the Mean|2.22||0.0047|2-Sided|95.0|2.0|10.7||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Baseline = Visit 2; Endpoint = the last non-missing post-baseline value until Visit 5; Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.|
1709995|NCT00836693|3146763|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|0.3|<|0.001|2-Sided|95.0|0.7|1.9||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1709996|NCT00836693|3146764|Superiority or Other||Mean Difference (Final Values)|0.8|Standard Error of the Mean|0.37||0.0461|2-Sided|95.0|0.0|1.5||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1709997|NCT00836693|3146765|Superiority or Other||Mean Difference (Final Values)|0.7|Standard Error of the Mean|0.25||0.0089|2-Sided|95.0|0.2|1.1||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1709998|NCT00836693|3146766|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|0.29|<|0.001|2-Sided|95.0|0.7|1.9||p-value is for Week 12 Change.For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1709999|NCT00836693|3146767|Superiority or Other||Mean Difference (Final Values)|7.5|Standard Error of the Mean|4.07||0.0653|2-Sided|95.0|-0.5|15.6||p-value is for Overall Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1710000|NCT00836693|3146767|Superiority or Other||Mean Difference (Final Values)|11.0|Standard Error of the Mean|3.52||0.002|2-Sided|95.0|4.1|17.9||p-value is for Self-Esteem Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1710012|NCT00836472|3146803|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|94.08||||||90.0|89.6|98.77|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710001|NCT00836693|3146767|Superiority or Other||Mean Difference (Final Values)|9.9|Standard Error of the Mean|3.34||0.0034|2-Sided|95.0|3.3|16.5||p-value is for Confidence Domain (Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1710002|NCT00836693|3146767|Superiority or Other||Mean Difference (Final Values)|13.2|Standard Error of the Mean|3.36|<|0.001|2-Sided|95.0|6.6|19.8||p-value is for Sexual Relationship Domain(Change).For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1710003|NCT00836693|3146767|Superiority or Other||Mean Difference (Final Values)|11.7|Standard Error of the Mean|3.17|<|0.001|2-Sided|95.0|5.5|18.0||p-value is for Total (Change). For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1710004|NCT00836693|3146768|Superiority or Other||Mean Difference (Final Values)|20.0|Standard Error of the Mean|3.11|>|0.001|2-Sided|95.0|13.9|26.1||p-value is for Week 12 Change. For secondary endpoints, all tests of hypotheses were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANOVA|||The models included terms for baseline value of the efficacy variable,treatment group,country, and the baseline-by-treatment-group interaction.In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1710005|NCT00836693|3146769|Superiority or Other||Mean Difference (Final Values)|16.2|Standard Error of the Mean|3.37|<|0.001|2-Sided|95.0|9.5|22.8||P-value is for Week 12 change. For secondary endpoints, all tests of hypotheses (null hypothesis versus the alternative hypothesis) were performed as two-sided tests at the 0.05 significance level (α=0.05) unless otherwise stated.|ANCOVA|Change = Endpoint - Baseline.||The change from baseline to endpoint in morning erection percentages was analyzed with an ANCOVA model including terms for baseline value, treatment group, country, age and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1710006|NCT00836693|3146773|Superiority or Other||Mean Difference (Final Values)|18.0|Standard Error of the Mean|4.6|<|0.001|2-Sided|95.0|8.9|27.0||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1710007|NCT00836693|3146774|Superiority or Other||Mean Difference (Final Values)|11.7|Standard Error of the Mean|3.35|<|0.001|2-Sided|95.0|5.1|18.3||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1710008|NCT00836693|3146775|Superiority or Other||Mean Difference (Final Values)|3.9|Standard Error of the Mean|0.85|<|0.001|2-Sided|95.0|2.2|5.5||p-value is for Week 12 Change. The null hypothesis concerning tadalafil versus placebo was to be rejected if, and only if, the three primary hypotheses (H01, H02, and H03) were all rejected therefore no adjustments for multiple comparisons were made.|ANCOVA|Change = Endpoint - Baseline.||Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.|
1710009|NCT00836589|3146787|Non-Inferiority|"Estimated SAEFR at 5 years is 92.5% with a 5% non-inferiority margin (87.5%).~Type I error (alpha) is 0.05 (one-sided for non-inferiority).~Statistical power is 80%."||||||0.002|||||||Binomial Proportion||||
1710010|NCT00836472|3146801|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.01||||||90.0|92.18|100.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710011|NCT00836472|3146802|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.33||||||90.0|92.6|100.21|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710425|NCT00833105|3147406|Superiority or Other||||||<|0.001||||||No multiple comparison adjustment.|Wilcoxon Signed Rank Test||||
1710013|NCT00836472|3146804|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.52||||||90.0|94.44|102.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710014|NCT00836472|3146805|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.78||||||90.0|95.14|102.57|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710015|NCT00836472|3146806|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.41||||||90.0|88.43|105.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710016|NCT00836342|3146817|Superiority or Other|||||||0.09|||||||t-test, 2 sided||||
1710017|NCT00836342|3146818|Superiority or Other|||||||0.49|||||||t-test, 2 sided||||
1710018|NCT00836342|3146819|Superiority or Other|||||||0.31|||||||t-test, 2 sided|||Null hypothesis: There is no difference in mean carotenoid levels between subjects with a history of squamous cell carcinom and control subjects.|
1710019|NCT00836056|3146827|Non-Inferiority or Equivalence|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|95.96||||||90.0|90.77|101.46|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710020|NCT00836056|3146828|Non-Inferiority or Equivalence|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|96.77||||||90.0|91.4|102.46|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710021|NCT00836056|3146829|Non-Inferiority or Equivalence|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|97.75||||||90.0|91.5|104.42|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710022|NCT00836004|3146835|Non-Inferiority or Equivalence|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|97.17||||||90.0|92.14|102.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710023|NCT00836004|3146836|Non-Inferiority or Equivalence|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|96.23||||||90.0|90.62|102.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710024|NCT00836004|3146837|Non-Inferiority or Equivalence|Using GLM procedures in SAS, ANOVA (Analysis of Variance) will be performed on log-transformed AUC0-t, AUC0-inf and Cmax at the alpha level of 0.05.|Test/Ref Ratio of LS Means x 100|99.69||||||90.0|93.88|105.85|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710025|NCT00835991|3146838|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.44||||||90.0|93.71|99.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710026|NCT00835991|3146839|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05|Test/Ref Ratio of LS Means x 100|96.55||||||90.0|93.85|99.32|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710027|NCT00835991|3146840|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.05||||||90.0|94.31|104.02|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710028|NCT00835991|3146841|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.36||||||90.0|98.32|104.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710029|NCT00835991|3146842|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.63||||||90.0|97.59|103.76|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710030|NCT00835991|3146843|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|114.05||||||90.0|107.26|121.27|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710031|NCT00835978|3146861|Superiority or Other||Hazard Ratio (HR)|0.849||||0.2444|2-Sided|95.0|0.535|1.348|||Log Rank||||
1710032|NCT00835978|3146862|Superiority or Other||Risk Ratio (RR)|1.578||||0.0189|2-Sided|95.0|1.017|2.448||A priori defined threshold for statistical significance was: alpha=0.10 (one-sided)|Cochran-Mantel-Haenszel|||ORR for the 2 treatment arms was compared with the Cochran-Mantel-Haenszel test stratified by ECOG performance status. The relative risk ratio estimator was used to contrast the treatment effects on the endpoint. Both a point estimate and a 2-sided 95% CI were calculated using a normal approximation.|
1710033|NCT00835796|3146878|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.8||||||90.0|94.5|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710034|NCT00835796|3146879|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.7||||||90.0|94.0|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710035|NCT00835796|3146880|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|94.2|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710036|NCT00835705|3146888|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|104.26||||||90.0|95.76|113.52|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710037|NCT00835705|3146889|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.79||||||90.0|95.75|112.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710038|NCT00835705|3146890|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.16||||||90.0|95.33|111.64|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710039|NCT00835705|3146891|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.29||||||90.0|96.58|100.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710040|NCT00835705|3146892|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|98.43||||||90.0|96.71|100.18|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710041|NCT00835705|3146893|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Least Squares Means|103.03||||||90.0|98.4|107.88|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710042|NCT00835692|3146894|Non-Inferiority or Equivalence|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|93.5||||||90.0|89.5|97.7|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710043|NCT00835692|3146895|Non-Inferiority or Equivalence|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Means x 100|93.5||||||90.0|89.6|97.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710044|NCT00835692|3146896|Non-Inferiority or Equivalence|The pharmacokinetic parameters will be evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Test/Ref Ratio of LS Mean x 100|98.4||||||90.0|91.5|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710045|NCT00835666|3146901|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.4||||||90.0|94.9|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710046|NCT00835666|3146902|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.2||||||90.0|94.7|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710047|NCT00835666|3146903|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.5||||||90.0|92.6|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710048|NCT00835640|3146904|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|88.45||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.||
1710049|NCT00835640|3146905|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|87.87||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.||
1710050|NCT00835640|3146906|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|81.33||||||90.0|||||||To establish bioequivalence, the ratio of the mean must fall within 80-125.||
1710051|NCT00835614|3146907|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|92.2||||||90.0|90.4|94.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710052|NCT00835614|3146908|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|92.1||||||90.0|90.3|93.9|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710053|NCT00835614|3146909|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|90.9||||||90.0|87.5|94.4|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710054|NCT00835588|3146910|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|95.6||||||90.0|91.6|99.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710426|NCT00833105|3147407|Superiority or Other||||||<|0.005||||||No multiple comparison adjustment.|Wilcoxon Signed Rank Test||||
1710056|NCT00835588|3146912|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|88.8||||||90.0|82.7|95.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710057|NCT00835575|3146913|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|103.87||||||90.0|99.47|108.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710058|NCT00835575|3146914|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|103.59||||||90.0|99.13|108.25|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710059|NCT00835575|3146915|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.52||||||90.0|92.84|106.69|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710060|NCT00835549|3146916|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|98.7|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710061|NCT00835549|3146917|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|98.5|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710062|NCT00835549|3146918|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|98.6||||||90.0|94.8|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710063|NCT00835536|3146919|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|96.5||||||90.0|92.1|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710064|NCT00835536|3146920|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|93.1|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710065|NCT00835510|3146921|Non-Inferiority or Equivalence|The criteria for equivalence is that the 90% confidence interval for the difference in cure rate had to be between -20% to +20%.|Cure rate difference|-19.78||||||90.0|-30.27|-9.29|||||||
1710066|NCT00835510|3146926|Superiority or Other||||||<|0.0001|||||||Fisher Exact|two-sided|||
1710067|NCT00835510|3146926|Superiority or Other||||||<|0.0127|||||||Fisher Exact|two-sided|||
1710068|NCT00835497|3146927|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|93.0||||||90.0|88.8|97.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710069|NCT00835497|3146928|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|92.7||||||90.0|88.4|97.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710070|NCT00835497|3146929|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|88.9||||||90.0|83.5|94.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710071|NCT00835497|3146930|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|94.2|99.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710072|NCT00835497|3146931|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|94.2|99.9|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710073|NCT00835497|3146932|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|86.5||||||90.0|81.8|91.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710074|NCT00835484|3146933|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|101.39||||||90.0|95.89|107.2|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710427|NCT00833105|3147408|Superiority or Other||||||<|0.0001||||||No multiple comparison procedure|Wilcoxon Signed Rank Test||||
1710075|NCT00835484|3146934|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.8||||||90.0|95.1|106.84|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710076|NCT00835484|3146935|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|97.15||||||90.0|91.77|102.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710077|NCT00835406|3146936|Non-Inferiority or Equivalence|ANOVA will be performed on ln-transformed Ae0-35 and Rmax at the α level of 0.05.|Ratio of the mean|100.36||||||90.0|92.85|108.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710078|NCT00835406|3146937|Non-Inferiority or Equivalence|ANOVA will be performed on ln-transformed Ae0-36 and Rmax at the α level of 0.05.|Ratio of the mean|97.94||||||90.0|90.96|105.45|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710079|NCT00835380|3146939|Superiority or Other||Seroconversion Rate|99.0||||||95.0|89.0|99.0|||||||
1710080|NCT00835367|3146940|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|100.28||||||90.0|98.25|102.35|||||Metabolite presented for informational purposes only.||
1710081|NCT00835367|3146941|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.72||||||90.0|100.3|105.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710082|NCT00835367|3146942|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.74||||||90.0|100.35|105.19|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710083|NCT00835367|3146943|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|100.28||||||90.0|98.3|102.3|||||Metabolite presented for informational purposes only||
1710084|NCT00835367|3146944|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|95.85||||||90.0|92.54|99.27|||||Metabolite presented for informational purposes only.||
1710085|NCT00835367|3146945|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|91.79||||||90.0|84.83|99.32|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710086|NCT00835367|3146946|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|102.49||||||90.0|99.75|105.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710087|NCT00835367|3146947|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Slope|102.53||||||90.0|99.71|105.44|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710088|NCT00835367|3146948|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|101.84||||||90.0|98.22|105.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710089|NCT00835354|3146949|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|90.7||||||90.0|89.1|92.3|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710090|NCT00835354|3146950|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|90.5||||||90.0|88.9|92.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710091|NCT00835354|3146951|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|89.2||||||90.0|86.2|92.2|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710092|NCT00835276|3146960|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|91.47||||||90.0|85.32|98.07|||||To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.||
1710093|NCT00835276|3146961|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|91.47||||||90.0|85.15|98.26|||||To establish bioequivalence, the mean values for the test product differ by no more that 20% from the repective mean values for the reference listed product.||
1710436|NCT00833105|3147417|Superiority or Other||||||<|0.025|||||||Mixed Models Analysis|Random subject effect|||
1710094|NCT00835276|3146962|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|87.96||||||90.0|80.15|96.53|||||To establish bioequivalence, the mean values for the test product differ by no more than 20% from the respective mean values for the reference listed product.||
1710095|NCT00835263|3146963|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|102.14||||||90.0|100.06|104.26|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710096|NCT00835263|3146964|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.31||||||90.0|100.75|105.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710097|NCT00835263|3146965|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.23||||||90.0|100.78|105.73|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710098|NCT00835211|3146977|Non-Inferiority or Equivalence|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|96.5||||||90.0|87.7|106.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710099|NCT00835211|3146978|Non-Inferiority or Equivalence|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|95.6||||||90.0|86.9|105.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710100|NCT00835211|3146979|Non-Inferiority or Equivalence|Analyses of Variance (ANOVA) were performed on the log-transformed AUC0-t, AUCinf and Cmax. These analyses were performed using the SAS® procedure.|Test/Ref Ratio of LS Means x 100|97.5||||||90.0|87.8|108.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710101|NCT00835172|3147002|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.0||||||90.0|99.3|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710102|NCT00835172|3147003|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|96.8|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710103|NCT00835172|3147004|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|92.1|112.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710104|NCT00835146|3147006|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.3||||||90.0|93.3|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710105|NCT00835146|3147007|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|97.9||||||90.0|91.8|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710106|NCT00835081|3147013|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.8||||||90.0|97.4|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%||
1710107|NCT00835081|3147014|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.5|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%||
1710108|NCT00835081|3147015|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|95.9|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%||
1710109|NCT00835042|3147026|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|97.6|108.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1710110|NCT00835042|3147027|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|98.9||||||90.0|94.6|103.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1710111|NCT00835042|3147028|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|91.0||||||90.0|81.8|101.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1711152|NCT00824291|3148518|Superiority or Other||Mean Difference (Net)|2.12||||0.002|2-Sided|95.0|0.78|3.46|||ANCOVA||||
1710112|NCT00835042|3147029|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.3||||||90.0|96.7|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710113|NCT00835042|3147030|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.1||||||90.0|96.4|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710114|NCT00835042|3147031|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|105.0||||||90.0|99.3|111.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710115|NCT00835042|3147032|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.1||||||90.0|92.3|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710116|NCT00835042|3147033|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|98.9||||||90.0|92.2|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710117|NCT00835042|3147034|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|92.5||||||90.0|85.8|99.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710118|NCT00835003|3147043|Non-Inferiority or Equivalence|Power calculations estimated a sample size of 1272 women with an estimated proportion of 8% in the 39 weeks Group and 14% in the 38 weeks group|Risk Ratio (RR)|0.86||||0.31|2-Sided|95.0|0.65|1.15|||Chi-squared||||
1710119|NCT00834990|3147044|Non-Inferiority or Equivalence|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|103.17||||||90.0|98.5|108.05|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710120|NCT00834990|3147045|Non-Inferiority or Equivalence|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|101.68||||||90.0|96.79|106.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710121|NCT00834990|3147046|Non-Inferiority or Equivalence|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|103.41||||||90.0|97.13|110.08|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710122|NCT00834977|3147047|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|99.24||||||90.0|96.21|102.35|||||Metabolite presented for informational purposes only.||
1710123|NCT00834977|3147048|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|96.99||||||90.0|92.52|101.68|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710124|NCT00834977|3147049|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|97.2||||||90.0|92.82|101.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710125|NCT00834977|3147050|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Slope|99.43||||||90.0|96.48|102.46|||||Metabolite presented for informational purposes only.||
1710126|NCT00834977|3147051|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|95.69||||||90.0|90.54|101.14|||||Metabolite presented for informational purposes only.||
1710127|NCT00834977|3147052|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|98.72||||||90.0|86.95|112.09|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710128|NCT00834977|3147053|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|98.48||||||90.0|95.8|101.23|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710129|NCT00834977|3147054|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|99.38||||||90.0|96.63|102.22|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710130|NCT00834977|3147055|Non-Inferiority or Equivalence|Parametric analysis of variance (ANOVA)on AUC0-t, AUCinf and Cmax; geometric Confidence Intervals for AUC0-t, AUC0-inf and Cmax|Ratio of Least Squares Means|101.08||||||90.0|97.23|105.09|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710131|NCT00834964|3147056|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|100.52||||||90.0|97.3|103.84|||||Metabolite results were not subjected to bioequivalence criteria, results are presented for informational purposes only.||
1710132|NCT00834964|3147057|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.1||||||90.0|100.08|108.29|||||Metaboite results not subjected to bioequivalence criteria, results are presented for informational purposes only.||
1710133|NCT00834964|3147058|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.29||||||90.0|91.96|100.82|||||Metabolite results not subjected to bioequivalence criteria; results are presented for informational purposes only.||
1710134|NCT00834964|3147059|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|98.6||||||90.0|93.46|104.02|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710135|NCT00834964|3147060|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.7||||||90.0|94.74|104.92|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710136|NCT00834964|3147061|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|97.0||||||90.0|92.72|101.49|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710137|NCT00834873|3147074|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.11||||||90.0|90.45|102.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710138|NCT00834873|3147075|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.23||||||90.0|90.59|102.23|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710139|NCT00834873|3147076|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|94.77||||||90.0|85.04|105.61|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710140|NCT00834795|3147084|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.36||||||90.0|90.2|102.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710141|NCT00834795|3147085|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|96.27||||||90.0|90.34|102.59|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710142|NCT00834795|3147086|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|95.16||||||90.0|85.69|105.67|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710143|NCT00834756|3147087|Non-Inferiority or Equivalence|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.37||||||90.0|93.95|107.21|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710144|NCT00834756|3147088|Non-Inferiority or Equivalence|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.63||||||90.0|92.34|105.35|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710145|NCT00834756|3147089|Non-Inferiority or Equivalence|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|96.0||||||90.0|87.96|104.78|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710146|NCT00834743|3147090|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.05||||||90.0|90.57|108.32|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710147|NCT00834743|3147091|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.0||||||90.0|91.44|107.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710148|NCT00834743|3147092|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.49||||||90.0|90.65|109.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710149|NCT00834717|3147093|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.95||||||90.0|83.11|103.97|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710428|NCT00833105|3147409|Superiority or Other||||||<|0.05||||||No multiple comparison procedure performed|Wilcoxon Signed Rank Test||||
1710150|NCT00834717|3147094|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|92.57||||||90.0|82.8|103.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710151|NCT00834717|3147095|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|97.86||||||90.0|92.36|103.69|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710152|NCT00834652|3147105|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1710153|NCT00834639|3147106|Non-Inferiority or Equivalence|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|100.36||||||90.0|97.35|103.46|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710154|NCT00834639|3147107|Non-Inferiority or Equivalence|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|100.59||||||90.0|97.07|104.24|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710155|NCT00834639|3147108|Non-Inferiority or Equivalence|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Ratio of the T/R geometric mean x 100|97.36||||||90.0|93.68|101.18|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710156|NCT00834613|3147113|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|97.63||||||90.0|95.22|100.1|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710157|NCT00834613|3147114|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|97.63||||||90.0|95.21|100.11|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710158|NCT00834613|3147115|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|103.45||||||90.0|99.87|107.15|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710159|NCT00834587|3147116|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.1||||||90.0|96.5|101.8|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710160|NCT00834587|3147117|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.2||||||90.0|96.5|102.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710161|NCT00834587|3147118|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|101.7||||||90.0|97.3|106.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710162|NCT00834587|3147119|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.6||||||90.0|98.8|102.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710163|NCT00834587|3147120|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.7||||||90.0|98.8|102.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710164|NCT00834587|3147121|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|99.1||||||90.0|92.4|106.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710165|NCT00834574|3147122|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|101.0|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710166|NCT00834574|3147123|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|101.0|114.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710167|NCT00834574|3147124|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|97.2|110.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710168|NCT00834561|3147125|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|103.68||||||90.0|101.42|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710169|NCT00834561|3147126|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.07||||||90.0|101.33|106.89|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710170|NCT00834561|3147127|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|104.14||||||90.0|99.99|108.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710171|NCT00834535|3147128|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|96.57||||||90.0|92.8|100.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710172|NCT00834535|3147129|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|96.1||||||90.0|92.14|100.22|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710173|NCT00834535|3147130|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.83||||||90.0|93.98|108.17|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710174|NCT00834522|3147131|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|104.22||||||90.0|96.9|112.08|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710175|NCT00834522|3147132|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|104.37||||||90.0|97.04|112.25|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710176|NCT00834522|3147133|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|103.79||||||90.0|99.4|108.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710177|NCT00834444|3147137|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.7|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710178|NCT00834444|3147138|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.0||||||90.0|97.9|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710179|NCT00834444|3147139|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|96.9||||||90.0|87.8|107.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710180|NCT00834431|3147140|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|98.7||||||90.0|96.3|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710181|NCT00834431|3147141|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|98.6||||||90.0|96.2|101.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710182|NCT00834431|3147142|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|92.0||||||90.0|85.9|98.6|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710183|NCT00834418|3147143|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|95.2|109.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710184|NCT00834418|3147144|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|107.0||||||90.0|99.6|116.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710185|NCT00834405|3147145|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|107.0||||||90.0|100.0|115.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710186|NCT00834405|3147146|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-72 and Cmax.|Geometric Test/Ref Ratio x 100|106.0||||||90.0|98.0|114.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710187|NCT00834340|3147152|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|102.0||||||90.0|98.7|105.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710188|NCT00834340|3147153|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.5||||||90.0|94.0|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710189|NCT00834340|3147154|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|101.0||||||90.0|92.2|111.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710190|NCT00834275|3147163|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.3|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%||
1710191|NCT00834275|3147164|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|98.3|105.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%||
1710192|NCT00834275|3147165|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.0||||||90.0|94.0|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%||
1710193|NCT00834249|3147166|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|106.38||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational purposes only.||
1710194|NCT00834249|3147167|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|106.85||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational puposes only.||
1710195|NCT00834249|3147168|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|109.61||||||90.0|||||||Metabolite results not subjected to bioequivalence criteria, results are presented for informational purposes only.||
1710196|NCT00834249|3147169|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.71||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.||
1710197|NCT00834249|3147170|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|99.73||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.||
1710198|NCT00834249|3147171|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Test/Ref Ratio of LS Means x 100|101.73||||||90.0|||||||Bioequivalence is established when ratio of means falls within 80-125.||
1710199|NCT00834197|3147177|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|98.25||||||90.0|95.22|101.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710200|NCT00834197|3147178|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|98.17||||||90.0|94.82|101.65|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710201|NCT00834197|3147179|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.59||||||90.0|95.76|105.65|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710202|NCT00834132|3147181|Non-Inferiority or Equivalence|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|101.14||||||90.0|96.05|106.49|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710203|NCT00834132|3147182|Non-Inferiority or Equivalence|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|100.89||||||90.0|96.0|106.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710204|NCT00834132|3147183|Non-Inferiority or Equivalence|Using PROC GLM procedures in SAS, analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|94.81||||||90.0|84.77|106.04|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710205|NCT00834106|3147184|Superiority or Other||Vaccine efficacy|93.2|||||2-Sided|95.0|72.9|99.2|||||Vaccine efficacy = 100 * [1 - (incidence rate with V501 / incidence rate with placebo)].||
1710207|NCT00834106|3147191|Superiority or Other||Vaccine efficacy|100.0||||0.0072|2-Sided|95.0|32.3|100.0|||Exact test, 1-sided||Vaccine efficacy = 100 * [1 - (incidence rate with V501 / incidence rate with placebo)]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.||
1710208|NCT00834106|3147192|Superiority or Other||Vaccine efficacy|82.3|||||2-Sided|95.0|38.3|96.7|||||Vaccine efficacy = 100 * [1 - (incidence rate with V501 / incidence rate with placebo)]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.||
1710209|NCT00834106|3147193|Superiority or Other||Vaccine efficacy|76.0|||||2-Sided|95.0|43.7|91.1|||||Vaccine efficacy = 100 * [1 - (incidence rate with V501 / incidence rate with placebo)]. The pre-specified success criterion was that the lower bound of the 95% confidence interval for vaccine efficacy excludes 0%.||
1710210|NCT00834067|3147195|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|98.1|108.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1710211|NCT00834067|3147196|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|102.0||||||90.0|99.0|106.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1710212|NCT00834067|3147197|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|107.0||||||90.0|99.8|114.0|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1710213|NCT00834067|3147198|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|99.4|103.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710214|NCT00834067|3147199|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|99.1|102.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710215|NCT00834067|3147200|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|101.0||||||90.0|96.0|106.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710216|NCT00834067|3147201|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|103.0||||||90.0|99.7|107.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710217|NCT00834067|3147202|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|104.0||||||90.0|99.9|108.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710218|NCT00834067|3147203|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|96.7||||||90.0|90.1|104.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710219|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|1.686|Standard Error of the Mean|1.7306|||2-Sided|95.0|-1.937|5.308|||||"Mean difference= GSK249320 15 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112|
1710220|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|-0.357|Standard Error of the Mean|1.2918|||2-Sided|95.0|-3.074|2.359|||||"Mean difference= GSK249320 5 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112|
1710221|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|0.852|Standard Error of the Mean|1.5675|||2-Sided|95.0|-2.446|4.15|||||"Mean difference= GSK249320 1 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 140%, Visit 7 Day 112|
1710222|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|0.11|Standard Error of the Mean|1.6603|||2-Sided|95.0|-3.369|3.588|||||"Mean difference= GSK249320 15 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30|
1710223|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|-0.508|Standard Error of the Mean|1.2985|||2-Sided|95.0|-3.219|2.203|||||"Mean difference= GSK249320 5 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30|
1710224|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|1.631|Standard Error of the Mean|1.589|||2-Sided|95.0|-1.696|4.958|||||"Mean difference= GSK249320 1 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 140%, Visit 4 Day 30|
1710225|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|2.219|Standard Error of the Mean|1.4792|||2-Sided|95.0|-0.884|5.322|||||"Mean difference= GSK249320 15 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112|
1710226|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|-0.556|Standard Error of the Mean|1.0822|||2-Sided|95.0|-2.838|1.726|||||"Mean difference= GSK249320 5 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112|
1710227|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|0.686|Standard Error of the Mean|1.2689|||2-Sided|95.0|-1.996|3.367|||||"Mean difference= GSK249320 1 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 130%, Visit 7 Day 112|
1710228|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|-0.185|Standard Error of the Mean|1.5697|||2-Sided|95.0|-3.471|3.101|||||"Mean difference= GSK249320 15 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30|
1710229|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|-0.531|Standard Error of the Mean|1.2336|||2-Sided|95.0|-3.102|2.041|||||"Mean difference= GSK249320 5 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30|
1710230|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|1.556|Standard Error of the Mean|1.4588|||2-Sided|95.0|-1.494|4.607|||||"Mean difference= GSK249320 1 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 130%, Visit 4 Day 30|
1710231|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|2.063|Standard Error of the Mean|1.281|||2-Sided|95.0|-0.61|4.736|||||"Mean difference= GSK249320 15 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112|
1710232|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|-0.602|Standard Error of the Mean|0.934|||2-Sided|95.0|-2.56|1.356|||||"Mean difference= GSK249320 5 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112|
1710233|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|0.622|Standard Error of the Mean|0.9746|||2-Sided|95.0|-1.428|2.672|||||"Mean difference= GSK249320 1 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 120%, Visit 7 Day 112|
1710234|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|-0.184|Standard Error of the Mean|1.4796|||2-Sided|95.0|-3.279|2.91|||||"Mean difference= GSK249320 15 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30|
1710235|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|-0.231|Standard Error of the Mean|1.1762|||2-Sided|95.0|-2.681|2.219|||||"Mean difference= GSK249320 5 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30|
1710236|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|1.644|Standard Error of the Mean|1.2976|||2-Sided|95.0|-1.056|4.344|||||"Mean difference= GSK249320 1 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 120%, Visit 4 Day 30|
1710237|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|1.506|Standard Error of the Mean|0.757|||2-Sided|95.0|-0.064|3.077|||||"Mean difference= GSK249320 15 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 110%, Visit 7 Day 112|
1710238|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|-0.007|Standard Error of the Mean|0.564|||2-Sided|95.0|-1.183|1.168|||||"Mean difference= GSK249320 5 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit"|Stimulation Level 110%, Visit 7 Day 112|
1710239|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|0.806|Standard Error of the Mean|0.5862|||2-Sided|95.0|-0.42|2.031|||||"Mean difference= GSK249320 1 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 110%, Visit 7 Day 112|
1710240|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|-0.269|Standard Error of the Mean|1.0383|||2-Sided|95.0|-2.436|1.898|||||"Mean difference= GSK249320 15 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30|
1710241|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|-0.518|Standard Error of the Mean|0.8324|||2-Sided|95.0|-2.249|1.213|||||"Mean difference= GSK249320 5 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30|
1710242|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|1.156|Standard Error of the Mean|0.8652|||2-Sided|95.0|-0.65|2.961|||||"Mean difference= GSK249320 1 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 110%, Visit 4 Day 30|
1710243|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|0.416|Standard Error of the Mean|0.2602|||2-Sided|95.0|-0.132|0.965|||||"Mean difference= GSK249320 15 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112|
1710244|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|0.105|Standard Error of the Mean|0.1846|||2-Sided|95.0|-0.284|0.494|||||"Mean difference= GSK249320 5 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112|
1710245|NCT00833989|3147210|Superiority or Other||Median Difference (Net)|0.204|Standard Error of the Mean|0.1841|||2-Sided|95.0|-0.184|0.593|||||"Mean difference= GSK249320 1 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 100%, Visit 7 Day 112|
1710246|NCT00833989|3147210|Superiority or Other||Median Difference (Net)|-0.303|Standard Error of the Mean|0.3172|||2-Sided|95.0|-0.966|0.361|||||"Mean difference= GSK249320 15 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 100%, Visit 4 Day 30|
1710247|NCT00833989|3147210|Superiority or Other||Mean Difference (Net)|-0.31|Standard Error of the Mean|0.2637|||2-Sided|95.0|-0.862|0.241|||||"Mean difference= GSK249320 5 mg/kg – Placebo~Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline"|Stimulation Level 100%, Visit 4 Day 30|
1710248|NCT00833989|3147210|Superiority or Other||Median Difference (Net)|-0.289|Standard Error of the Mean|0.2639|||2-Sided|95.0|-0.841|0.264|||||Mean difference= GSK249320 1 mg/kg – Placebo Change from Baseline= Treatment + Visit + Treatment* Visit + Baseline|Stimulation Level 100%, Visit 4 Day 30|
1710249|NCT00833989|3147211|Superiority or Other||Mean Difference (Net)|-0.06|Standard Error of the Mean|1.486|||2-Sided|95.0|-3.09|2.98|||||"Mean difference= GSK249320 15 mg/kg – Placebo.~Day 90 GDS Score= Treatment+Day 5 GDS Score"|Placebo Vs GSK249320 15 mg/kg, Visit 6|
1710250|NCT00833989|3147211|Superiority or Other||Mean Difference (Net)|1.55|Standard Error of the Mean|1.347|||2-Sided|95.0|-1.2|4.3|||||"Mean difference= GSK249320 5 mg/kg – Placebo~Day 90 GDS Score= Treatment + Day 5 GDS Score"|Placebo Vs GSK249320 5 mg/kg, Visit 6|
1710251|NCT00833989|3147211|Superiority or Other||Mean Difference (Net)|-0.24|Standard Error of the Mean|1.408|||2-Sided|95.0|-3.12|2.63|||||"Mean difference= GSK249320 1 mg/kg – Placebo.~Day 90 GDS Score= Treatment + Day 5 GDS Score"|Placebo Vs GSK249320 1 mg/kg, Visit 6|
1710252|NCT00833989|3147212|Superiority or Other||Mean Difference (Net)|-1.15|Standard Error of the Mean|2.037|||2-Sided|95.0|-5.31|3.01|||||Mean difference= GSK249320 15 mg/kg – Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 15 mg/kg, Visit 6|
1710253|NCT00833989|3147212|Superiority or Other||Median Difference (Net)|-0.17|Standard Error of the Mean|1.856|||2-Sided|95.0|-3.96|3.62|||||Mean difference= GSK249320 5 mg/kg – Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 5 mg/kg, Visit 6|
1710254|NCT00833989|3147212|Superiority or Other||Mean Difference (Net)|-0.34|Standard Error of the Mean|1.849|||2-Sided|95.0|-4.12|3.43|||||Mean difference= GSK249320 1 mg/kg – Placebo Day 90 MoCA = Treatment + Day 5 MoCA|Placebo Vs GSK249320 1 mg/kg, Visit 6|
1710255|NCT00833989|3147213|Superiority or Other||Mean Difference (Net)|-7.49|Standard Error of the Mean|9.641|||2-Sided|95.0|-27.1|12.08|||||Mean difference= GSK249320 15 mg/kg – Placebo Barthel Total Score= Treatment + Visit + Treatment *Visit|Placebo Vs GSK249320 15 mg/kg, Visit 6|
1710256|NCT00833989|3147213|Superiority or Other||Mean Difference (Net)|11.56|Standard Error of the Mean|8.835|||2-Sided|95.0|-6.38|29.5|||||Mean difference= GSK249320 5 mg/kg – Placebo Barthel Total Score= Treatment + Visit + Treatment *Visit|Placebo Vs GSK249320 5 mg/kg, Visit 6|
1710257|NCT00833989|3147213|Superiority or Other||Mean Difference (Net)|15.71|Standard Error of the Mean|9.021|||2-Sided|95.0|-2.63|34.06|||||Mean difference= GSK249320 1 mg/kg – Placebo Barthel Total Score= Treatment + Visit + Treatment *Visit|Placebo Vs GSK249320 1 mg/kg, Visit 6|
1710258|NCT00833989|3147213|Superiority or Other||Mean Difference (Net)|11.79|Standard Error of the Mean|13.143|||2-Sided|95.0|-14.9|38.5|||||Mean difference= GSK249320 15 mg/kg – Placebo Barthel Total Score= Treatment + Visit + Treatment *Visit|Placebo Vs GSK249320 15 mg/kg, Visit 4|
1710259|NCT00833989|3147213|Superiority or Other||Mean Difference (Net)|20.99|Standard Error of the Mean|12.131|||2-Sided|95.0|-3.66|45.64|||||Mean difference= GSK249320 5 mg/kg – Placebo Barthel Total Score= Treatment + Visit + Treatment *Visit|Placebo Vs GSK249320 5 mg/kg, Visit 4|
1710260|NCT00833989|3147213|Superiority or Other||Mean Difference (Net)|19.46|Standard Error of the Mean|12.584|||2-Sided|95.0|-6.11|45.04|||||Mean difference= GSK249320 1 mg/kg – Placebo Barthel Total Score= Treatment + Visit + Treatment *Visit|Placebo Vs GSK249320 1 mg/kg, Visit 4|
1710261|NCT00833989|3147214|Superiority or Other||Median Difference (Net)|-0.37|Standard Error of the Mean|2.21|||2-Sided|95.0|-0.66|1.408|||||Mean difference= GSK249320 15 mg/kg – Placebo Change from Baseline = Treatment + Visit + Treatment * Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 6|
1710262|NCT00833989|3147214|Superiority or Other||Mean Difference (Net)|-0.37|Standard Error of the Mean|1.278|||2-Sided|95.0|-2.97|2.24|||||Mean difference= GSK249320 5 mg/kg – Placebo Change from Baseline = Treatment + Visit + Treatment * Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 6|
1710263|NCT00833989|3147214|Superiority or Other||Median Difference (Net)|-1.03|Standard Error of the Mean|1.278|||2-Sided|95.0|-3.64|1.57|||||Mean difference= GSK249320 1 mg/kg – Placebo Change from Baseline = Treatment + Visit + Treatment * Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 6|
1710264|NCT00833989|3147214|Superiority or Other||Median Difference (Net)|-0.92|Standard Error of the Mean|0.904|||2-Sided|95.0|-2.77|0.92|||||Mean difference= GSK249320 15 mg/kg – Placebo Change from Baseline = Treatment + Visit + Treatment * Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 4|
1710265|NCT00833989|3147214|Superiority or Other||Median Difference (Net)|-0.27|Standard Error of the Mean|0.834|||2-Sided|95.0|-1.98|1.44|||||Mean difference= GSK249320 5 mg/kg – Placebo Change from Baseline = Treatment + Visit + Treatment * Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 4|
1710266|NCT00833989|3147214|Superiority or Other||Mean Difference (Net)|-0.7|Standard Error of the Mean|0.868|||2-Sided|95.0|-2.47|1.08|||||Mean difference= GSK249320 1 mg/kg – Placebo Change from Baseline = Treatment + Visit + Treatment * Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 4|
1710267|NCT00833989|3147214|Superiority or Other||Mean Difference (Net)|-2.92|Standard Error of the Mean|0.933|||2-Sided|95.0|-4.83|-1.02|||||Mean difference= GSK249320 15 mg/kg – Placebo Change from Baseline = Treatment + Visit + Treatment * Visit + Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 3|
1710268|NCT00833989|3147214|Superiority or Other||Mean Difference (Net)|-0.19|Standard Error of the Mean|0.861|||2-Sided|95.0|-1.95|1.57|||||Mean difference= GSK249320 5 mg/kg – Placebo Change from Baseline = Treatment + Visit + Treatment * Visit + Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 3|
1710269|NCT00833989|3147214|Superiority or Other||Median Difference (Net)|-1.34|Standard Error of the Mean|0.896|||2-Sided|95.0|-3.17|0.49|||||Mean difference= GSK249320 1 mg/kg – Placebo Change from Baseline = Treatment + Visit + Treatment * Visit + Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 3|
1710270|NCT00833989|3147215|Superiority or Other|||||||0.5647|||||||Fisher Exact|||Visit 6|
1710271|NCT00833989|3147215|Superiority or Other|||||||0.926|||||||Fisher Exact|||Visit 4|
1710272|NCT00833989|3147216|Superiority or Other||Mean Difference (Net)|3.73|Standard Error of the Mean|4.396|||2-Sided|95.0|-5.22|12.69|||||"Mean difference= GSK249320 15 mg/kg – Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 7|
1710273|NCT00833989|3147216|Superiority or Other||Mean Difference (Net)|-2.58|Standard Error of the Mean|4.376|||2-Sided|95.0|-11.5|6.32|||||"Mean difference= GSK249320 5 mg/kg – Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 7|
1710274|NCT00833989|3147216|Superiority or Other||Mean Difference (Net)|3.04|Standard Error of the Mean|4.205|||2-Sided|95.0|-5.53|11.61|||||"Mean difference= GSK249320 1 mg/kg – Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 7|
1710275|NCT00833989|3147216|Superiority or Other||Median Difference (Net)|0.77|Standard Error of the Mean|4.28|||2-Sided|95.0|-7.97|9.5|||||"Mean difference= GSK249320 15 mg/kg – Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 6|
1710276|NCT00833989|3147216|Superiority or Other||Mean Difference (Net)|0.49|Standard Error of the Mean|4.235|||2-Sided|95.0|-8.15|9.12|||||"Mean difference= GSK249320 5 mg/kg – Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 6|
1710661|NCT00829413|3147901|Superiority or Other||Difference in Sensitivity (%)|75.6|||<|0.0001|2-Sided|95.0|67.9|83.3|||McNemar||||
1710277|NCT00833989|3147216|Superiority or Other||Mean Difference (Net)|3.46|Standard Error of the Mean|4.109|||2-Sided|95.0|-4.94|11.85|||||"Mean difference= GSK249320 1 mg/kg – Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 6|
1710278|NCT00833989|3147216|Superiority or Other||Mean Difference (Net)|1.44|Standard Error of the Mean|3.978|||2-Sided|95.0|-6.68|9.55|||||"Mean difference= GSK249320 15 mg/kg – Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 5|
1710279|NCT00833989|3147216|Superiority or Other||Median Difference (Net)|-2.35|Standard Error of the Mean|3.958|||2-Sided|95.0|-10.4|5.72|||||"Mean difference= GSK249320 5 mg/kg – Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 5|
1710280|NCT00833989|3147216|Superiority or Other||Mean Difference (Net)|2.05|Standard Error of the Mean|3.841|||2-Sided|95.0|-5.78|9.89|||||"Mean difference= GSK249320 1 mg/kg – Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 5|
1710281|NCT00833989|3147216|Superiority or Other||Mean Difference (Net)|4.56|Standard Error of the Mean|3.534|||2-Sided|95.0|-2.67|11.78|||||"Mean difference= GSK249320 15 mg/kg – Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 4|
1710282|NCT00833989|3147216|Superiority or Other||Mean Difference (Net)|-0.3|Standard Error of the Mean|3.55|||2-Sided|95.0|-7.56|6.96|||||"Mean difference= GSK249320 5 mg/kg – Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 4|
1710283|NCT00833989|3147216|Superiority or Other||Mean Difference (Net)|1.66|Standard Error of the Mean|3.42|||2-Sided|95.0|-5.33|8.65|||||"Mean difference= GSK249320 1 mg/kg – Placebo.~Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4|
1710284|NCT00833989|3147217|Superiority or Other||Mean Difference (Net)|-0.5|Standard Error of the Mean|7.328|||2-Sided|95.0|-15.4|14.39|||||Mean difference= GSK249320 15 mg/kg – Placebo Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 7|
1710285|NCT00833989|3147217|Superiority or Other||Mean Difference (Net)|3.52|Standard Error of the Mean|6.909|||2-Sided|95.0|-10.5|17.55|||||Mean difference= GSK249320 5 mg/kg – Placebo Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 7|
1710286|NCT00833989|3147217|Superiority or Other||Mean Difference (Net)|2.25|Standard Error of the Mean|6.953|||2-Sided|95.0|-11.9|16.4|||||Mean difference= GSK249320 1 mg/kg – Placebo Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 7|
1710287|NCT00833989|3147217|Superiority or Other||Median Difference (Net)|-0.95|Standard Error of the Mean|7.02|||2-Sided|95.0|-15.2|13.32|||||Mean difference= GSK249320 15 mg/kg – Placebo Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 6|
1710288|NCT00833989|3147217|Superiority or Other||Mean Difference (Net)|1.03|Standard Error of the Mean|6.595||||95.0|-12.4|14.43|||||Mean difference= GSK249320 5 mg/kg – Placebo Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 6|
1710289|NCT00833989|3147217|Superiority or Other||Median Difference (Net)|0.63|Standard Error of the Mean|6.664|||2-Sided|95.0|-12.9|14.18|||||Mean difference= GSK249320 1 mg/kg – Placebo Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 6|
1710290|NCT00833989|3147217|Superiority or Other||Mean Difference (Net)|-2.22|Standard Error of the Mean|6.82|||2-Sided|95.0|-16.1|11.68|||||Mean difference= GSK249320 15 mg/kg – Placebo Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 5|
1710291|NCT00833989|3147217|Superiority or Other||Mean Difference (Net)|2.05|Standard Error of the Mean|6.426|||2-Sided|95.0|-11.0|15.12|||||Mean difference= GSK249320 5 mg/kg – Placebo Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 5|
1710292|NCT00833989|3147217|Superiority or Other||Mean Difference (Net)|1.2|Standard Error of the Mean|6.504|||2-Sided|95.0|-12.1|14.45|||||Mean difference= GSK249320 1 mg/kg – Placebo Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 1 mg/kg, Visit 5|
1710293|NCT00833989|3147217|Superiority or Other||Mean Difference (Net)|4.85|Standard Error of the Mean|5.409|||2-Sided|95.0|-6.17|15.88|||||Mean difference= GSK249320 15 mg/kg – Placebo Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 15 mg/kg, Visit 4|
1710294|NCT00833989|3147217|Superiority or Other||Mean Difference (Net)|2.75|Standard Error of the Mean|5.157|||2-Sided|95.0|-7.75|13.26|||||Mean difference= GSK249320 5 mg/kg – Placebo Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline|Placebo Vs GSK249320 5 mg/kg, Visit 4|
1710295|NCT00833989|3147217|Superiority or Other||Mean Difference (Net)|0.13|Standard Error of the Mean|5.147|||2-Sided|95.0|-10.4|10.61|||||"Mean difference= GSK249320 1 mg/kg – Placebo~Affected Change from Baseline = Treatment + Visit + Treatment * Visit + Affected Baseline + Unaffected Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4|
1710296|NCT00833989|3147218|Superiority or Other||Median Difference (Net)|-10.07|Standard Error of the Mean|10.916|||2-Sided|95.0|-32.29|12.15|||||"Mean difference= GSK249320 15 mg/kg – Placebo~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment * Visit + Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 7|
1710297|NCT00833989|3147218|Superiority or Other||Mean Difference (Net)|5.03|Standard Error of the Mean|10.31|||2-Sided|95.0|-15.95|26.0|||||"Mean difference= GSK249320 5 mg/kg – Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment * Visit + Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 7|
1710662|NCT00829413|3147901|Superiority or Other||Difference in Sensitivity (%)|40.3|||<|0.0001|2-Sided|95.0|30.4|50.3|||McNemar||||
1710298|NCT00833989|3147218|Superiority or Other||Median Difference (Net)|-2.4|Standard Error of the Mean|10.04|||2-Sided|95.0|-22.87|18.07|||||"Mean difference= GSK249320 1 mg/kg – Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment * Visit + Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 7|
1710299|NCT00833989|3147218|Superiority or Other||Median Difference (Net)|-5.4|Standard Error of the Mean|7.376|||2-Sided|95.0|-20.41|9.6|||||"Mean difference= GSK249320 15 mg/kg – Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment * Visit + Baseline"|Placebo Vs GSK249320 15 mg/kg, Visit 4|
1710300|NCT00833989|3147218|Superiority or Other||Median Difference (Net)|9.86|Standard Error of the Mean|6.852|||2-Sided|95.0|-4.08|23.8|||||"Mean difference= GSK249320 5 mg/kg – Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment * Visit + Baseline"|Placebo Vs GSK249320 5 mg/kg, Visit 4|
1710301|NCT00833989|3147218|Superiority or Other||Mean Difference (Net)|-1.47|Standard Error of the Mean|7.047|||2-Sided|95.0|-15.81|12.86|||||"Mean difference= GSK249320 1 mg/kg – Placebo.~Change in Total Fugl-Meyer assessment= Treatment + Visit + Treatment * Visit + Baseline"|Placebo Vs GSK249320 1 mg/kg, Visit 4|
1710302|NCT00833989|3147219|Superiority or Other||Mean Difference (Net)|-3.11|Standard Error of the Mean|6.768|||2-Sided|95.0|-17.1|10.84|||||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 7|
1710303|NCT00833989|3147219|Superiority or Other||Mean Difference (Net)|5.89|Standard Error of the Mean|5.948|||2-Sided|95.0|-6.37|18.15|||||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7|
1710304|NCT00833989|3147219|Superiority or Other||Mean Difference (Net)|9.59|Standard Error of the Mean|6.134|||2-Sided|95.0|-3.07|22.24|||||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, visit 7|
1710305|NCT00833989|3147219|Superiority or Other||Mean Difference (Net)|-10.63|Standard Error of the Mean|5.959|||2-Sided|95.0|-22.9|1.6|||||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 6|
1710306|NCT00833989|3147219|Superiority or Other||Mean Difference (Net)|7.45|Standard Error of the Mean|5.198|||2-Sided|95.0|-3.22|18.13|||||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 6|
1710307|NCT00833989|3147219|Superiority or Other||Mean Difference (Net)|9.66|Standard Error of the Mean|5.351|||2-Sided|95.0|-1.34|20.66|||||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 6|
1710308|NCT00833989|3147219|Superiority or Other||Mean Difference (Final Values)|0.49|Standard Error of the Mean|6.195|||2-Sided|95.0|-12.2|13.21|||||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 5|
1710309|NCT00833989|3147219|Superiority or Other||Mean Difference (Net)|8.77|Standard Error of the Mean|5.411|||2-Sided|95.0|-2.35|19.89|||||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 5|
1710310|NCT00833989|3147219|Superiority or Other||Mean Difference (Net)|11.58|Standard Error of the Mean|5.631|||2-Sided|95.0|0.01|23.15|||||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 5|
1710311|NCT00833989|3147219|Superiority or Other||Median Difference (Final Values)|0.09|Standard Error of the Mean|5.47|||2-Sided|95.0|-11.1|11.24|||||Mean difference= GSK249320 GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 4|
1710312|NCT00833989|3147219|Superiority or Other||Mean Difference (Net)|8.47|Standard Error of the Mean|4.801|||2-Sided|95.0|-1.32|18.26|||||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 4|
1710313|NCT00833989|3147219|Superiority or Other||Mean Difference (Net)|9.56|Standard Error of the Mean|4.981|||2-Sided|95.0|-0.6|19.71|||||Mean difference =GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, visit 4|
1710314|NCT00833989|3147220|Superiority or Other||Mean Difference (Net)|0.17|Standard Error of the Mean|0.277|||2-Sided|95.0|-0.39|0.73|||||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7|
1710315|NCT00833989|3147220|Superiority or Other||Mean Difference (Net)|0.59|Standard Error of the Mean|0.242|||2-Sided|95.0|0.09|1.08|||||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 7|
1710316|NCT00833989|3147220|Superiority or Other||Mean Difference (Net)|0.61|Standard Error of the Mean|0.251|||2-Sided|95.0|0.1|1.12|||||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 7|
1710317|NCT00833989|3147220|Superiority or Other||Mean Difference (Net)|0.24|Standard Error of the Mean|0.259|||2-Sided|95.0|-0.29|0.77|||||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 6|
1710318|NCT00833989|3147220|Superiority or Other||Mean Difference (Net)|0.4|Standard Error of the Mean|0.225|||2-Sided|95.0|-0.06|0.86|||||Mean difference= GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 6|
1710319|NCT00833989|3147220|Superiority or Other||Mean Difference (Net)|0.63|Standard Error of the Mean|0.235|||2-Sided|95.0|0.15|1.11|||||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 6|
1710320|NCT00833989|3147220|Superiority or Other||Mean Difference (Net)|0.04|Standard Error of the Mean|0.319|||2-Sided|95.0|-0.61|0.69|||||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 5|
1710321|NCT00833989|3147220|Superiority or Other||Mean Difference (Net)|0.52|Standard Error of the Mean|0.279|||2-Sided|95.0|-0.05|1.09|||||Mean difference= GSK249320 5 mg/kg- Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 5|
1710322|NCT00833989|3147220|Superiority or Other||Mean Difference (Net)|0.35|Standard Error of the Mean|0.292|||2-Sided|95.0|-0.24|0.95|||||Mean difference= GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 5|
1710323|NCT00833989|3147220|Superiority or Other||Mean Difference (Net)|0.3|Standard Error of the Mean|0.246|||2-Sided|95.0|-0.2|0.8|||||Mean difference= GSK249320 15 mg/kg - Placebo|Placebo Vs GSK249320 15 mg/kg, Visit 4|
1710324|NCT00833989|3147220|Superiority or Other||Mean Difference (Net)|0.69|Standard Error of the Mean|0.214|||2-Sided|95.0|0.25|1.13|||||Mean difference = GSK249320 5 mg/kg - Placebo|Placebo Vs GSK249320 5 mg/kg, Visit 4|
1710325|NCT00833989|3147220|Superiority or Other||Mean Difference (Net)|0.45|Standard Error of the Mean|0.231|||2-Sided|95.0|-0.03|0.92|||||Mean difference = GSK249320 1 mg/kg - Placebo|Placebo Vs GSK249320 1 mg/kg, Visit 4|
1710326|NCT00833937|3147238|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.9||||||90.0|92.7|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710663|NCT00829413|3147901|Superiority or Other||Difference in Sensitivity (%)|37.8|||<|0.0001|2-Sided|95.0|27.4|48.2|||McNemar||||
1710327|NCT00833937|3147239|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.8||||||90.0|92.6|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710328|NCT00833937|3147240|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|99.7||||||90.0|93.9|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710329|NCT00833924|3147241|Superiority or Other||12-month Device Success Rate|97.3|||<|0.01|2-Sided|95.0|92.4|99.4|||Exact binomial test|||Null hypothesis: The 12-month device success for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (84%).|
1710330|NCT00833924|3147242|Superiority or Other||Rate of 30-day freedom from MAE|99.2|||<|0.01|2-Sided|95.0|95.4|100.0|||Exact binomial test|||Null hypothesis: The 30-day Freedom from MAE for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (88%).|
1710331|NCT00833898|3147244|Superiority or Other|||||||0.72||||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)||||
1710332|NCT00833898|3147244|Superiority or Other|||||||0.43||||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)||||
1710333|NCT00833898|3147245|Superiority or Other|||||||0.72||||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)||||
1710334|NCT00833898|3147245|Superiority or Other|||||||0.43||||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)||||
1710335|NCT00833898|3147246|Superiority or Other|||||||1||||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)||||
1710336|NCT00833898|3147246|Superiority or Other|||||||0.18||||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)||||
1710337|NCT00833898|3147247|Superiority or Other|||||||0.53|||||||Mixed Models Analysis||||
1710338|NCT00833898|3147248|Superiority or Other|||||||0.33||||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)||||
1710339|NCT00833898|3147248|Superiority or Other|||||||0.58||||||P-values represent separate wilcoxon paired sample signed rank test.|Wilcoxon (Mann-Whitney)||||
1710340|NCT00833898|3147249|Superiority or Other|||||||0.26|||||||Mixed Models Analysis||||
1710341|NCT00833898|3147250|Superiority or Other|||||||0.8|||||||Mixed Models Analysis||||
1710342|NCT00833898|3147251|Superiority or Other|||||||0.013|||||||Mixed Models Analysis||||
1710343|NCT00833898|3147252|Superiority or Other|||||||0.67|||||||Mixed Models Analysis||||
1710344|NCT00833898|3147253|Superiority or Other|||||||0.3|||||||Mixed Models Analysis||||
1710345|NCT00833898|3147254|Superiority or Other|||||||0.55|||||||Mixed Models Analysis||||
1710346|NCT00833898|3147255|Superiority or Other|||||||0.97|||||||Mixed Models Analysis||||
1710347|NCT00833898|3147256|Superiority or Other|||||||0.17|||||||Mixed Models Analysis||||
1710348|NCT00833898|3147257|Superiority or Other|||||||0.75|||||||Mixed Models Analysis||||
1710349|NCT00833898|3147258|Superiority or Other|||||||0.44|||||||Mixed Models Analysis||||
1710350|NCT00833898|3147259|Superiority or Other|||||||0.4|||||||Mixed Models Analysis||||
1710351|NCT00833898|3147260|Superiority or Other|||||||0.012|||||||Mixed Models Analysis||||
1710352|NCT00833898|3147261|Superiority or Other|||||||0.003|||||||Mixed Models Analysis||||
1710353|NCT00833898|3147262|Superiority or Other|||||||0.029|||||||Mixed Models Analysis||||
1710354|NCT00833898|3147263|Superiority or Other|||||||0.15|||||||Mixed Models Analysis||||
1710355|NCT00833898|3147264|Superiority or Other|||||||0.02|||||||Mixed Models Analysis||||
1710356|NCT00833833|3147270|Superiority or Other||Cox Proportional Hazard|0.85|||||2-Sided|95.0|0.57|1.29|||||||
1710357|NCT00833833|3147271|Superiority or Other|||||||0.07|||||||Wilcoxon (Mann-Whitney)||||
1710358|NCT00833833|3147272|Superiority or Other||Cox Proportional Hazard|6.25|||||2-Sided|95.0|0.84|46.66|||||||
1710359|NCT00833833|3147277|Superiority or Other||Cox Proportional Hazard|0.73|||||2-Sided|95.0|0.54|0.99||||||With a 12-month accrual period and 12-month follow-up after the study closed to accrual, assuming a 10% drop out rate, 96 participants in each treatment arm would have had 85% power to detect a hazard rate ratio of 1.67 using a one-sided log rank test with an overall significance level of 0.025 adjusted for one interim analysis) and a significance level of 0.0245 for the final analysis.|
1710360|NCT00833755|3147293|Superiority or Other|||||||0.004|||||||Kruskal-Wallis||||
1710361|NCT00833755|3147294|Superiority or Other|||||||0.552|||||||Kruskal-Wallis||||
1710362|NCT00833755|3147295|Superiority or Other|||||||0.274|||||||Kruskal-Wallis||||
1710363|NCT00833664|3147338|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.2||||||90.0|92.7|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710364|NCT00833664|3147339|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|107.6||||||90.0|104.7|110.6|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710365|NCT00833664|3147340|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.2||||||90.0|88.1|109.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710366|NCT00833638|3147341|Superiority or Other||Mean Difference (Final Values)|-25.11|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the percentages of successful intercourse attempts exist in participants who received tadalafil 2.5 mg in the double-blind treatment period and did not respond to treatment when comparing their percentage of succesful intercourse attempts between the double-blind treatment period and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."|
1710367|NCT00833638|3147342|Superiority or Other||Mean Difference (Final Values)|-18.16|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalfil 5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."|
1710368|NCT00833638|3147343|Superiority or Other||Mean Difference (Final Values)|-22.22|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalafil 2.5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 2.5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."|
1710369|NCT00833638|3147344|Superiority or Other||Mean Difference (Final Values)|-36.05|||<|0.001||95.0|||||t-test, 2 sided||the estimated mean difference shows changes in the double-blind treatment phase minus changes in the open label treatment phase|"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received placebo in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving placebo) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3."|
1710370|NCT00833638|3147345|Superiority or Other|||||||0.246||||||P-value for day <=1. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710371|NCT00833638|3147345|Superiority or Other|||||||0.008||||||P-value for day <=2. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710372|NCT00833638|3147345|Superiority or Other|||||||0.003||||||P-value for day <=3. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710373|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=4. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710374|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=5. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710375|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=6. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710376|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=7. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710377|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=8. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710378|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=9. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710379|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=10. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710429|NCT00833105|3147410|Superiority or Other||||||<|0.01|||||||Wilcoxon Signed-Rank|No multiple comparison procedure||Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.|
1710380|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=11. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710381|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=12. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710382|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=13. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710383|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=14. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710384|NCT00833638|3147345|Superiority or Other||||||<|0.038||||||P-value for day <=2. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710385|NCT00833638|3147345|Superiority or Other||||||<|0.009||||||P-value for day <=3. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710386|NCT00833638|3147345|Superiority or Other||||||<|0.002||||||P-value for day <=4. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710387|NCT00833638|3147345|Superiority or Other||||||<|0.002||||||P-value for day <=5. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710388|NCT00833638|3147345|Superiority or Other||||||<|0.002||||||P-value for day <=6. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710389|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=7. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710390|NCT00833638|3147345|Superiority or Other||||||<|0.002||||||P-value for day <=8. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710391|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=9. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710392|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=10. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710393|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=11. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710394|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=12. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710430|NCT00833105|3147411|Superiority or Other|||||||0.164|||||||Mixed Models Analysis|Random subject effect|||
1710395|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=13. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710396|NCT00833638|3147345|Superiority or Other||||||<|0.001||||||P-value for day <=14. No adjustment for multiplicity.|Regression, Logistic|Response = Treatment + Pooled Site + Severity of ED at Baseline.||"Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710397|NCT00833638|3147346|Superiority or Other|||||||0.046||||||No adjustment for multiplicity.|Log Rank|||"Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710398|NCT00833638|3147346|Superiority or Other|||||||0.301||||||No adjustment for multiplicity.|Log Rank|||"Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3."|
1710399|NCT00833638|3147347|Superiority or Other||Mean Difference (Final Values)|19.07|||<|0.001|2-Sided|95.0|11.4|26.75||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 5 mg."|
1710400|NCT00833638|3147347|Superiority or Other||Mean Difference (Final Values)|13.92|||<|0.001|2-Sided|95.0|6.3|21.55||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 2.5 mg."|
1710401|NCT00833638|3147348|Superiority or Other||Mean Difference (Final Values)|21.81|||<|0.001|2-Sided|95.0|13.94|29.67||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 5 mg."|
1710402|NCT00833638|3147348|Superiority or Other||Mean Difference (Final Values)|14.24|||<|0.001|2-Sided|95.0|6.42|22.06||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 2.5 mg."|
1710403|NCT00833638|3147349|Superiority or Other||Mean Difference (Final Values)|20.54|||<|0.001|2-Sided|95.0|13.07|28.01||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 5 mg."|
1710404|NCT00833638|3147349|Superiority or Other||Mean Difference (Final Values)|14.27|||<|0.001|2-Sided|95.0|6.83|21.71||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 2.5 mg."|
1710405|NCT00833638|3147350|Superiority or Other||Mean Difference (Final Values)|20.41|||<|0.001|2-Sided|95.0|13.5|27.31||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 5 mg."|
1710406|NCT00833638|3147350|Superiority or Other||Mean Difference (Final Values)|15.4|||<|0.001|2-Sided|95.0|8.51|22.29||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 2.5 mg."|
1710407|NCT00833638|3147351|Superiority or Other||Mean Difference (Final Values)|12.8|||<|0.001|2-Sided|95.0|6.48|19.12||No adjustment for multiplicity.|ANCOVA|Terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction were included.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 5 mg."|
1710408|NCT00833638|3147351|Superiority or Other||Mean Difference (Final Values)|12.03|||<|0.001|2-Sided|95.0|5.72|18.34||No adjustment for multiplicity.|ANCOVA|Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction were included.||"Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 2.5 mg."|
1710431|NCT00833105|3147412|Superiority or Other|||||||0.371|||||||Mixed Models Analysis|Random subject effect|||
1710432|NCT00833105|3147413|Superiority or Other|||||||0.951|||||||Mixed Models Analysis|Random subject effects|||
1710409|NCT00833638|3147352|Superiority or Other|||||||0.573||||||P-value for day <=1. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p>.025.|Regression, Logistic|||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.|
1710410|NCT00833638|3147352|Superiority or Other|||||||0.022||||||P-value for day <=2. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.|
1710411|NCT00833638|3147352|Superiority or Other|||||||0.019||||||P-value for day <=3. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.|
1710412|NCT00833638|3147352|Superiority or Other|||||||0.006||||||P-value for day <=4. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.|
1710413|NCT00833638|3147352|Superiority or Other|||||||0.086||||||P-value for day <=4. A fixed-sequence test was used within each dose group at each time point (days 4, 3, 2, 1) and adjusted for multiple dose-placebo comparisons using the Bonferroni method. Testing started on day 4 and stopped when p>.025.|Regression, Logistic|Model response = treatment + pooled site + severity of erectile dysfunction at baseline.||The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 2.5 mg and placebo as determined by the earliest day on which the cumulative percentage of subjects achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.|
1710414|NCT00833586|3147353|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|102.4||||||90.0|95.0|110.5|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710415|NCT00833586|3147354|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|98.9||||||90.0|82.7|118.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710416|NCT00833586|3147355|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Test/Ref Ratio of LS Means x 100|95.1||||||90.0|85.8|105.4|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710417|NCT00833560|3147358|Superiority or Other||Percentage of participants with response|87.7|||<|0.0001|2-Sided|95.0|83.6|91.0|||Two-sided binomial test||||
1710418|NCT00833560|3147359|Superiority or Other||Percentage of participants with response|85.4|||<|0.0001|2-Sided|95.0|81.5|88.8|||Two - sided binomial test||||
1710419|NCT00833521|3147362|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|96.8||||||90.0|90.7|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710420|NCT00833521|3147363|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|97.0||||||90.0|91.0|103.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710421|NCT00833521|3147364|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Ratio of Geometric Means|91.1||||||90.0|86.3|96.1|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710422|NCT00833248|3147403|Non-Inferiority or Equivalence|Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.|Mean Difference (Final Values)|-0.268||||0.9123|2-Sided|95.0|-5.05|4.52|||ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||PP analysis set. Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.|
1710423|NCT00833248|3147404|Non-Inferiority or Equivalence|Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets.|Mean Difference (Final Values)|-0.3||||0.8942|2-Sided|95.0|-4.74|4.14|||ANCOVA|The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis.||FAS. Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates.|
1710424|NCT00833105|3147405|Superiority or Other||||||<|0.001||||||No multiple comparisons adjustment.|Wilcoxon Signed Rank Test||||
1710437|NCT00833040|3147426|Superiority or Other||Mean Difference (Final Values)|17.3|Standard Error of the Mean|4.49|<|0.001||95.0|||||ANCOVA|||difference between the active and placebo groups|
1710438|NCT00833027|3147428|Superiority or Other||Mean Difference (Net)|-0.6|Standard Deviation|0.85|<|0.001|1-Sided|95.0|||||Student's T-test|Student’s T-test for paired samples|||
1710439|NCT00832650|3147463|Superiority or Other||LS Mean difference|0.051|||||2-Sided|95.0|-0.334|0.436|||||Least squares mean was calculated based on the ANCOVA model with treatment group as a fixed effect and baseline values, age and Body Mass Index (BMI) as covariates.|Null H10: μF8mg=μS10mg where μF8mg and μS10mg are means of GC24 for fesoterodine 8mg and solifenacin 10mg, respectively.|
1710440|NCT00832455|3147480|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|Change in PACQLQ score between Week 12 and baseline is statistically different than zero|||
1710441|NCT00832455|3147481|Superiority or Other||||||<|0.001|||||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of patient satisfaction at week 0 compared to week 12.|||
1710442|NCT00832455|3147482|Superiority or Other||||||<|0.001|||||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 8.|||
1710443|NCT00832455|3147482|Superiority or Other||||||<|0.001|||||||McNemar-Bowker|The McNemar-Bowker test is a statistical procedure used to compare the proportion of physician satisfaction at week 0 compared to week 12.|||
1710444|NCT00832455|3147484|Superiority or Other||||||<|0.001|||||||McNemar||||
1710445|NCT00832455|3147484|Superiority or Other||||||<|0.001|||||||McNemar||||
1710446|NCT00832377|3147495|Superiority or Other||||||<|0.0001||||||Week 12 8-HR IOP vs. baseline|paired t-test||||
1710447|NCT00832377|3147496|Superiority or Other||||||<|0.0001||||||Week 12 trough IOP vs. baseline|paired t-test||||
1710448|NCT00832377|3147497|Superiority or Other||||||<|0.0001||||||Week 12 peak IOP vs. baseline|paired t-test||||
1710449|NCT00832000|3147524|Superiority or Other||Mean Difference (Final Values)|10.4|Standard Error of the Mean|6.5||0.03|2-Sided|95.0|0.941|20.6|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710450|NCT00832000|3147524|Superiority or Other||Mean Difference (Final Values)|-0.351|Standard Deviation|6.5||0.9|2-Sided|95.0|-5.87|5.17|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710451|NCT00832000|3147525|Superiority or Other||Mean Difference (Final Values)|5.58|Standard Deviation|5.35|<|0.001|2-Sided|95.0|3.44|7.72|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710452|NCT00832000|3147526|Superiority or Other||Mean Difference (Final Values)|-2.69|Standard Deviation|3.44|<|0.001|2-Sided|95.0|-4.07|-1.3|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710453|NCT00832000|3147527|Superiority or Other||Mean Difference (Final Values)|1.69|Standard Deviation|12.6||0.5|2-Sided|95.0|-3.34|6.73|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710454|NCT00832000|3147528|Superiority or Other||Mean Difference (Final Values)|-0.464|Standard Deviation|0.516|<|0.001|2-Sided|95.0|-0.675|-0.254|||Wilcoxon (Mann-Whitney)||Residual standard deviation.|P value indicates significance level of the Wilcoxon test associated with mexiletine effect from the linear mixed effects model. The Wilcoxon test was substituted because the outcome is not continuous and therefore normality of the residuals is not satisfied. All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710455|NCT00832000|3147529|Superiority or Other||Mean Difference (Final Values)|-0.313|Standard Deviation|0.889|<|0.001|2-Sided|95.0|-0.602|-0.149|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710456|NCT00832000|3147530|Superiority or Other||Mean Difference (Final Values)|-0.33|Standard Deviation|1.083|<|0.001|2-Sided|95.0|-0.633|-0.142|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710457|NCT00832000|3147531|Superiority or Other||Mean Difference (Final Values)|-0.568|Standard Deviation|0.6|<|0.001|2-Sided|95.0|-0.812|-0.325|||Wilcoxon (Mann-Whitney)||Residual standard deviation.|P value indicates significance level of the Wilcoxon test associated with mexiletine effect from the linear mixed effects model. The Wilcoxon test was substituted because the outcome is not continuous and therefore normality of the residuals is not satisfied. All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710458|NCT00832000|3147532|Superiority or Other||Mean Difference (Final Values)|4.54|Standard Deviation|13.1||0.09|2-Sided|95.0|-0.68|9.75|||wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710459|NCT00832000|3147533|Superiority or Other||Mean Difference (Final Values)|-0.109|Standard Deviation|0.563|<|0.001|2-Sided|95.0|-0.177|-0.056|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710460|NCT00832000|3147534|Superiority or Other||Mean Difference (Final Values)|-0.918|Standard Deviation|1.29|<|0.001|2-Sided|95.0|-1.3|-0.532|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710461|NCT00832000|3147535|Superiority or Other||Mean Difference (Final Values)|-1.26|Standard Deviation|1.27|<|0.001|2-Sided|95.0|-1.67|-0.861|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710462|NCT00832000|3147536|Superiority or Other||Mean Difference (Final Values)|-1.63|Standard Deviation|1.19|<|0.001|2-Sided|95.0|-2.0|-1.26|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model. When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710463|NCT00832000|3147537|Superiority or Other||Mean Difference (Final Values)|-3.68|Standard Deviation|1.24||0.04||95.0|-3.85|-0.139|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model (n=57). When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710464|NCT00832000|3147537|Superiority or Other||Mean Difference (Final Values)|-1.68|Standard Deviation|1.24|<|0.001|2-Sided|95.0|-2.66|-0.706|||Wald||Residual standard deviation.|P value indicates significance level of the Wald test associated with mexiletine effect from the linear mixed effects model (n=57). When a carryover effect was detected, the significance level associated with the additive portion of the mexiletine effect (labeled period 1) is followed by the level associated with the interaction of mexiletine and period 2 (labeled period 2). All P values were 2-sided and .05 was considered the threshold of statistical significance.|
1710465|NCT00831779|3147544|Superiority or Other||Mean Difference (Final Values)|28.13|Standard Error of the Mean|14.4984||0.0598|2-Sided|95.0|-1.22|57.48||Secondary endpoint was tested following a sequential testing procedure at alpha=0.05|ANOVA||||
1710466|NCT00831779|3147545|Superiority or Other||Mean Difference (Final Values)|19.97|Standard Error of the Mean|7.4685||0.0059|2-Sided|95.0|5.75|36.1||Primary endpoint was tested at alpha=0.05|ANOVA||||
1710467|NCT00831441|3147568|Superiority or Other||Hazard Ratio (HR)|2.36|||<|0.0001|2-Sided|95.0|2.06|2.7|||Cox Proportional Hazard model||||
1710468|NCT00831441|3147569|Superiority or Other||Hazard Ratio (HR)|2.64|||<|0.0001|2-Sided|95.0|1.87|3.72|||Cox Proportional Hazard model||||
1710469|NCT00831441|3147570|Superiority or Other||Hazard Ratio (HR)|2.48|||<|0.0001|2-Sided|95.0|1.72|3.58|||Cox Proportional Hazard model||||
1710470|NCT00831441|3147571|Superiority or Other||Hazard Ratio (HR)|2.59||||0.0006|2-Sided|95.0|1.5|4.46|||Cox Proportional Hazard model|||A point estimate and two-sided 95% confidence interval (CI) for relative risk, as measured by the hazard ratio and a p-value for the test of equality of rates (HR = 1) was calculated.|
1710471|NCT00831441|3147572|Superiority or Other||Hazard Ratio (HR)|0.99||||0.8948|2-Sided|95.0|0.85|1.15|||Cox proportional hazard models||||
1710472|NCT00831441|3147573|Superiority or Other||Hazard Ratio (HR)|0.98||||0.8015|2-Sided|95.0|0.83|1.15|||Cox proportional hazard models||||
1710473|NCT00831441|3147574|Superiority or Other||Hazard Ratio (HR)|0.94||||0.4317|2-Sided|95.0|0.82|1.09|||Cox proportional hazard models||||
1710474|NCT00831441|3147575|Superiority or Other||Hazard Ratio (HR)|0.73||||0.1502|2-Sided|95.0|0.47|1.12|||Cox proportional hazard models||||
1710475|NCT00831441|3147576|Superiority or Other||Hazard Ratio (HR)|0.93||||0.5086|2-Sided|95.0|0.76|1.14|||Cox proportional hazard models||||
1710476|NCT00831441|3147577|Superiority or Other||Hazard Ratio (HR)|0.9||||0.6311|2-Sided|95.0|0.57|1.4|||Cox proportional hazard models||||
1710477|NCT00831441|3147578|Superiority or Other||Hazard Ratio (HR)|0.94||||0.6702|2-Sided|95.0|0.7|1.26|||Cox proportional hazard models||||
1710478|NCT00831441|3147579|Superiority or Other||Hazard Ratio (HR)|0.95||||0.5094|2-Sided|95.0|0.8|1.11|||Cox proportional hazard models|||A test of superiority at the one-sided α = 0.025 significance level for the primary efficacy outcome was performed.|
1710479|NCT00831389|3147590|Superiority or Other|||||||0.0176||||||p < 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of hypoglycemic events over 48 hour in-patient period for the OL and CL phases do not differ.|
1710480|NCT00831389|3147591|Superiority or Other|||||||0.021||||||p < 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is below euglycemic range for the OL and CL phases do not differ.|
1710481|NCT00831389|3147592|Superiority or Other|||||||0.6221||||||p < 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is above euglycemic range for the OL and CL phases do not differ.|
1710482|NCT00831389|3147593|Superiority or Other|||||||0.2036||||||p < 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median percentage of time PG is within euglycemic range for the OL and CL phases do not differ.|
1710483|NCT00831389|3147594|Superiority or Other|||||||0.791||||||p < 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median overnight nadir PG for the OL and CL arms do not differ.|
1710484|NCT00831389|3147595|Superiority or Other|||||||0.2256||||||p < 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median nadir PG immediately following exercise for the OL and CL study phases do not differ.|
1710485|NCT00831389|3147596|Superiority or Other|||||||0.0669||||||p < 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median peak post-prandial PG for the OL and CL study phases do not differ.|
1710486|NCT00831389|3147597|Superiority or Other|||||||0.25||||||p < 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of nocturnal hypoglycemic events following exercise for the OL and CL study phases do not differ.|
1710487|NCT00831389|3147598|Superiority or Other|||||||0.5||||||p < 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median tally of hypoglycemic events immediately following exercise for the OL and CL study phases do not differ.|
1710488|NCT00831389|3147599|Superiority or Other|||||||0.791||||||p < 0.05 is considered significant.|Wilcoxon (Mann-Whitney)|||Null hypothesis: Median change in PG concentration due to exercise for the OL and CL study phases do not differ.|
1710489|NCT00831272|3147607|Superiority or Other|||||||0.32|||||||Generalized Estimating Equation||||
1710490|NCT00831233|3147613|Superiority or Other||Mean Difference (Final Values)|-7.83||||0.1018|2-Sided|95.0|-17.3|1.64|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.|
1710491|NCT00831233|3147614|Superiority or Other||Mean Difference (Final Values)|12.2||||0.5984|2-Sided|95.0|-34.4|58.8|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.|
1710492|NCT00831233|3147614|Superiority or Other||Mean Difference (Final Values)|5.91||||0.8284|2-Sided|95.0|-49.1|60.9|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.|
1710493|NCT00831233|3147614|Superiority or Other||Mean Difference (Final Values)|15.2||||0.5627|2-Sided|95.0|-37.8|68.2|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.|
1710494|NCT00831233|3147615|Superiority or Other||Mean Difference (Final Values)|2.02||||0.3186|2-Sided|95.0|-2.04|6.08|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 12. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.|
1710495|NCT00831233|3147615|Superiority or Other||Mean Difference (Final Values)|1.46||||0.455|2-Sided|95.0|-2.46|5.38|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.|
1710496|NCT00831233|3147615|Superiority or Other||Mean Difference (Final Values)|-0.553||||0.8151|2-Sided|95.0|-5.33|4.22|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.|
1710497|NCT00831233|3147616|Superiority or Other||Mean Difference (Final Values)|-0.983||||0.6917|2-Sided|95.0|-5.98|4.02|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 8. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.|
1710498|NCT00831233|3147616|Superiority or Other||Mean Difference (Final Values)|-2.47||||0.2298|2-Sided|95.0|-6.58|1.64|||ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis for the FAS.||Week 4. Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.|
1710499|NCT00831233|3147617|Non-Inferiority or Equivalence|"The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.~If the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used."|Mean Difference (Final Values)|-5.88||||0.0398|2-Sided|95.0|-11.5|-0.291||PP analysis set.|ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.|
1710500|NCT00831233|3147617|Non-Inferiority or Equivalence|"The trial was positive if the treatment contrast of degarelix versus goserelin plus bicalutamide in adjusted (for baseline total IPSS, age, and country) mean change from baseline in total IPSS was statistically significantly smaller (two-sided at α=0.05 level) than Δ=3 points in both the FAS and the PP analysis set.~If the Week 12 treatment assessment of IPSS was missing the LOCF approach was used, i.e., the IPSS closest to and before Week 12 was used."|Mean Difference (Final Values)|-2.95||||0.1973|2-Sided|95.0|-7.51|1.61||FAS.|ANCOVA|The baseline score, age, and country were used as covariates and treatment was used as a factor in the analysis.||Estimates from analysis of variance with treatment and country as factors and age and baseline value as covariates.|
1710501|NCT00830960|3147647|Superiority or Other|||||||0.034|||||||Fisher Exact||||
1710502|NCT00830960|3147647|Superiority or Other|||||||0.683|||||||Fisher Exact||||
1710503|NCT00830960|3147647|Superiority or Other|||||||0.427|||||||Fisher Exact||||
1710504|NCT00830960|3147647|Superiority or Other|||||||0.255|||||||Fisher Exact||||
1710505|NCT00830960|3147654|Superiority or Other||LS mean difference in PRU|-51.0||||0.002|2-Sided|95.0|-83.0|-19.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710617|NCT00829868|3147840|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|100.0||||||90.0|96.2|104.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710506|NCT00830960|3147654|Superiority or Other||LS mean difference in PRU|-92.0|||<|0.0001|2-Sided|95.0|-123.0|-60.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710507|NCT00830960|3147654|Superiority or Other||LS mean difference in PRU|-110.0|||<|0.0001|2-Sided|95.0|-143.0|-76.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710508|NCT00830960|3147656|Superiority or Other||LS Mean Difference in Percent Inhibition|32.0|||<|0.0001|2-Sided|95.0|18.0|45.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710509|NCT00830960|3147656|Superiority or Other||LS Mean Difference in Percent Inhibition|11.0|||<|0.1898|2-Sided|95.0|-5.0|27.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710510|NCT00830960|3147656|Superiority or Other||LS Mean Difference in Percent Inhibition|28.0|||<|0.0005|2-Sided|95.0|13.0|44.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710511|NCT00830960|3147656|Superiority or Other||LS Mean Difference in Percent Inhibition|35.0|||<|0.0001|2-Sided|95.0|18.0|52.0||"P-value for 90 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710512|NCT00830960|3147656|Superiority or Other||LS Mean Difference in Percent Inhibition|37.0|||<|0.0001|2-Sided|95.0|24.0|50.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710513|NCT00830960|3147656|Superiority or Other||LS Mean Difference in Percent Inhibition|17.0|||<|0.0026|2-Sided|95.0|6.0|28.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710514|NCT00830960|3147656|Superiority or Other||LS Mean Difference in Percent Inhibition|32.0|||<|0.0001|2-Sided|95.0|21.0|42.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710515|NCT00830960|3147656|Superiority or Other||LS Mean Difference in Percent Inhibition|38.0|||<|0.0001|2-Sided|95.0|27.0|50.0||"P-value for 30 days post-LD~Linear mixed effects model: treatment, visit (30, 90 days during MD), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710516|NCT00830960|3147657|Superiority or Other||LS Mean Difference in Percent Inhibition|56.0|||<|0.0001|2-Sided|95.0|44.0|68.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710517|NCT00830960|3147657|Superiority or Other||LS Mean Difference in Percent Inhibition|48.0|||<|0.0001|2-Sided|95.0|36.0|59.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710518|NCT00830960|3147657|Superiority or Other||LS Mean Difference in Percent Inhibition|62.0|||<|0.0001|2-Sided|95.0|47.0|76.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710519|NCT00830960|3147657|Superiority or Other||LS Mean Difference in Percent Inhibition|49.0|||<|0.0001|2-Sided|95.0|36.0|61.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710655|NCT00829413|3147899|Superiority or Other||Difference in Accuracy (%)|75.6|||<|0.0001|2-Sided|95.0|67.9|83.3|||McNemar||||
1710520|NCT00830960|3147657|Superiority or Other||LS Mean Difference in Percent Inhibition|36.0|||<|0.0001|2-Sided|95.0|23.0|48.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710521|NCT00830960|3147657|Superiority or Other||LS Mean Difference in Percent Inhibition|51.0|||<|0.0001|2-Sided|95.0|36.0|66.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710522|NCT00830960|3147657|Superiority or Other||LS Mean Difference in Percent Inhibition|11.0|||<|0.0054|2-Sided|95.0|3.0|19.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710523|NCT00830960|3147657|Superiority or Other||LS Mean Difference in Percent Inhibition|9.0|||<|0.0647|2-Sided|95.0|-1.0|18.0||"P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710524|NCT00830960|3147657|Superiority or Other||LS Mean Difference in Percent Inhibition|15.0|||<|0.0072|2-Sided|95.0|4.0|27.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit (0.5 hours to 4 hours), treatment-by-visit interaction, gender, country as fixed effects, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710525|NCT00830960|3147658|Superiority or Other||LS Mean Difference in PRU|-100.0|||<|0.0001|2-Sided|95.0|-143.0|-57.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710526|NCT00830960|3147658|Superiority or Other||LS Mean Difference in PRU|-35.0|||<|0.0647|2-Sided|95.0|-72.0|2.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710527|NCT00830960|3147658|Superiority or Other||LS Mean Difference in PRU|-85.0|||<|0.0001|2-Sided|95.0|-121.0|-48.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710528|NCT00830960|3147658|Superiority or Other||LS Mean Difference in PRU|-113.0|||<|0.0001|2-Sided|95.0|-154.0|-73.0||"P-value for 90 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710529|NCT00830960|3147658|Superiority or Other||LS Mean Difference in PRU|-119.0|||<|0.0001|2-Sided|95.0|-166.0|-73.0||"P-value for 30 days. A linear mixed effects model including treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU was prasugrel - clopidogrel."|LS Mean Difference in PRU|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710530|NCT00830960|3147659|Superiority or Other||LS mean difference in PRU|-212.0|||<|0.0001|2-Sided|95.0|-259.0|-167.0||"P-value for 4 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710531|NCT00830960|3147659|Superiority or Other||LS mean difference in PRU|-171.0|||<|0.0001|2-Sided|95.0|-216.0|-125.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710532|NCT00830960|3147659|Superiority or Other||LS mean difference in PRU|-115.0|||<|0.0001|2-Sided|95.0|-156.0|-73.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710533|NCT00830960|3147659|Superiority or Other||LS mean difference in PRU|-160.0|||<|0.0001|2-Sided|95.0|-211.0|-110.0||"P-value for 2 hours post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710656|NCT00829413|3147899|Superiority or Other||Difference in Accuracy (%)|34.0|||<|0.0001|2-Sided|95.0|27.3|40.7|||McNemar||||
1710534|NCT00830960|3147659|Superiority or Other||LS mean difference in PRU|-68.0|||<|0.0004|2-Sided|95.0|-104.0|-32.0||"P-value for 30 minutes post-LD Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710535|NCT00830960|3147659|Superiority or Other||LS mean difference in PRU|-35.0|||<|0.0365|2-Sided|95.0|-68.0|-2.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel"|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710536|NCT00830960|3147659|Superiority or Other||LS mean difference in PRU|-57.0|||<|0.0058|2-Sided|95.0|-97.0|-17.0||"P-value for 30 minutes post-LD~Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate the denominator degrees of freedom for fixed effects. Invalid measurements were excluded.|||
1710537|NCT00830960|3147660|Superiority or Other||LS Mean Difference in PRU|-139.0|||<|0.0001|2-Sided|95.0|-177.0|-102.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.|||
1710538|NCT00830960|3147660|Superiority or Other||Least Square (LS) Mean Difference in PRU|-183.0|||<|0.0001|2-Sided|95.0|-229.0|-137.0||"Linear mixed effects model: treatment, visit, treatment-by-visit interaction, gender, country as fixed effects, baseline PRU as covariate, participant as random effect was used.~Difference in PRU = prasugrel - clopidogrel."|Mixed Models Analysis|Kenward-Roger method was used to estimate denominator degrees of freedom for fixed effects. Invalid measurements excluded.|||
1710539|NCT00830791|3147706|Superiority or Other||Geometric Mean Ratio|0.0|||||2-Sided|90.0|0.0|0.5|||||||
1710540|NCT00830791|3147707|Superiority or Other||Geometric Mean Ratio|0.0|||||2-Sided|90.0|0.0|0.5|||||||
1710541|NCT00830791|3147709|Superiority or Other||Geometric Mean Ratio|1.14||||0.505|2-Sided|90.0|0.81|1.6|||ANCOVA||The mean square error on a log scale for this comparison was 0.133.||
1710542|NCT00830791|3147711|Superiority or Other||Geometric Mean Ratio|1.63||||0.014|2-Sided|90.0|1.21|2.2|||ANCOVA||The mean square error on a log scale was 0.104 for this comparison.||
1710543|NCT00830791|3147712|Superiority or Other||Geometric Mean Ratio|0.95||||0.718|2-Sided|90.0|0.76|1.2|||ANCOVA||The mean square error on a log scale was 0.061 for this comparison.||
1710544|NCT00830791|3147713|Superiority or Other||Geometric Mean Ratio|0.74||||0.325|2-Sided|90.0|0.43|1.26|||ANCOVA||The mean square error on a log scale for this comparison was 0.322.||
1710545|NCT00830336|3147734|Non-Inferiority or Equivalence|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|107.04||||||90.0|99.96|114.62|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710546|NCT00830336|3147735|Non-Inferiority or Equivalence|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|105.84||||||90.0|99.33|112.77|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710547|NCT00830336|3147736|Non-Inferiority or Equivalence|The pharmacokinetic parameters were evaluated statistically by an analysis of variance (ANOVA) appropriate for the experimental design of this study.|Geometric Test/Ref Ratio x 100|103.08||||||90.0|95.41|111.37|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710548|NCT00830310|3147737|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.|
1710549|NCT00830310|3147738|Superiority or Other|||||||0.002|||||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.|
1710550|NCT00830310|3147739|Superiority or Other|||||||0.038|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.|
1710551|NCT00830310|3147740|Superiority or Other|||||||0.011|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.|
1710552|NCT00830310|3147741|Superiority or Other|||||||0.001|||||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.|
1710553|NCT00830310|3147742|Superiority or Other|||||||0.001|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.|
1710554|NCT00830310|3147743|Superiority or Other|||||||0.001|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.|
1710555|NCT00830310|3147744|Superiority or Other|||||||0.002|||||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.|
1710556|NCT00830310|3147745|Superiority or Other||||||<|0.001|||||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.|
1710557|NCT00830258|3147748|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|110.61||||||90.0|104.39|117.2|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710558|NCT00830258|3147749|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|110.45||||||90.0|104.31|116.96|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710559|NCT00830258|3147750|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|105.76||||||90.0|98.17|113.93|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1711153|NCT00824265|3148538|Superiority or Other|||||||0.0166|||||||Cochran-Mantel-Haenszel||||
1710560|NCT00830219|3147754|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|102.54||||||90.0|97.53|107.8|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710561|NCT00830219|3147755|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|102.3||||||90.0|97.56|107.27|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710562|NCT00830219|3147756|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|103.53||||||90.0|99.16|108.09|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710563|NCT00830206|3147757|Non-Inferiority or Equivalence|An analysis of variance (ANOVA) was performed on the pharmacokimetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|101.92||||||90.0|95.18|109.14|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710564|NCT00830206|3147758|Non-Inferiority or Equivalence|An analysis of variance (ANOVA) was performed on the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|100.85||||||90.0|94.48|107.65|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710565|NCT00830206|3147759|Non-Inferiority or Equivalence|An analysis of variance (ANOVA) was performed on the pharmacokinetic parameters using SAS® Software.|Geometric Test/Ref Ratio x 100|102.62||||||90.0|94.84|111.05|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710566|NCT00830167|3147760|Superiority or Other||Mean Difference (Final Values)|-6.19|Standard Error of the Mean|2.04||0.0013|2-Sided|95.0|-10.2|-2.18||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710567|NCT00830167|3147761|Superiority or Other||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.28||0.1561|2-Sided|95.0|-0.83|0.27||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710568|NCT00830167|3147762|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.25||0.0262|2-Sided|95.0|-0.97|0.01||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710569|NCT00830167|3147763|Superiority or Other||Mean Difference (Final Values)|2.64|Standard Error of the Mean|1.39||0.0287|2-Sided|95.0|-0.08|5.37||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710570|NCT00830167|3147764|Superiority or Other||Mean Difference (Final Values)|4.42|Standard Error of the Mean|1.72||0.0052|2-Sided|95.0|1.04|7.8||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710571|NCT00830167|3147765|Superiority or Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|1.92||0.548|2-Sided|95.0|-4.0|3.54||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710572|NCT00830167|3147766|Superiority or Other||Mean Difference (Final Values)|1.59|Standard Error of the Mean|1.94||0.2068|2-Sided|95.0|-2.23|5.41||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710573|NCT00830167|3147767|Superiority or Other||Mean Difference (Final Values)|1.83|Standard Error of the Mean|1.2||0.0648|2-Sided|95.0|-0.54|4.19||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710574|NCT00830167|3147768|Superiority or Other||Mean Difference (Final Values)|2.15|Standard Error of the Mean|1.5||0.077|2-Sided|95.0|-0.81|5.1||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710575|NCT00830167|3147769|Superiority or Other||Mean Difference (Final Values)|1.68|Standard Error of the Mean|1.84||0.1805|2-Sided|95.0|-1.93|5.29||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710576|NCT00830167|3147770|Superiority or Other||Mean Difference (Final Values)|4.29|Standard Error of the Mean|1.32||0.0006|2-Sided|95.0|1.7|6.88||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710657|NCT00829413|3147899|Superiority or Other||Difference in Accuracy (%)|21.6|||<|0.0001|2-Sided|95.0|14.1|29.2|||McNemar||||
1710658|NCT00829413|3147900|Superiority or Other||Difference in Specificity (%)|50.7|||<|0.0001|2-Sided|95.0|42.0|59.5|||McNemar||||
1710577|NCT00830167|3147771|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.2||0.4165|2-Sided|95.0|-0.44|0.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710578|NCT00830167|3147772|Superiority or Other||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.22||0.1011|2-Sided|95.0|-0.72|0.15||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710579|NCT00830167|3147773|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.22||0.2568|2-Sided|95.0|-0.57|0.29||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710580|NCT00830167|3147774|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|0.21||0.0023|2-Sided|95.0|-1.01|-0.18||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710581|NCT00830167|3147775|Superiority or Other||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.2||0.0075|2-Sided|95.0|-0.89|-0.1||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710582|NCT00830167|3147776|Superiority or Other||Mean Difference (Final Values)|-0.41|Standard Error of the Mean|0.21||0.0238|2-Sided|95.0|-0.81|0.0||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710583|NCT00830167|3147777|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.21||0.0729|2-Sided|95.0|-0.74|0.11||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710584|NCT00830167|3147778|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.21||0.4768|2-Sided|95.0|-0.42|0.4||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710585|NCT00830167|3147779|Superiority or Other||Mean Difference (Final Values)|-0.63|Standard Error of the Mean|0.25||0.0052|2-Sided|95.0|-1.12|-0.15||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710586|NCT00830167|3147780|Superiority or Other||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.16||0.0376|2-Sided|95.0|-0.59|0.03||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710587|NCT00830167|3147781|Superiority or Other||Mean Difference (Final Values)|-3.33|Standard Error of the Mean|1.52||0.0144|2-Sided|95.0|-6.31|-0.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710588|NCT00830167|3147782|Superiority or Other||Mean Difference (Final Values)|-0.73|Standard Error of the Mean|0.17|<|0.0001|2-Sided|95.0|-1.06|-0.4||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710589|NCT00830167|3147783|Superiority or Other||Odds Ratio (OR)|1.45||||0.0687|2-Sided|95.0|0.9|2.35||The analysis was conducted using 1-sided test with the significance level of 0.025.|Regression, Logistic|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710590|NCT00830167|3147784|Superiority or Other||Mean Difference (Final Values)|-2.99|Standard Error of the Mean|1.35||0.0137|2-Sided|95.0|-5.65|-0.33||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710591|NCT00830167|3147785|Superiority or Other||Mean Difference (Final Values)|11.31|Standard Error of the Mean|1.82||1|2-Sided|95.0|7.74|14.87||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710592|NCT00830167|3147786|Superiority or Other||Mean Difference (Final Values)|7.48|Standard Error of the Mean|1.99|<|0.0001|2-Sided|95.0|3.58|11.38||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710593|NCT00830167|3147787|Superiority or Other||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.09||0.0007|2-Sided|95.0|0.11|0.47||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710659|NCT00829413|3147900|Superiority or Other||Difference in Specificity (%)|28.6|||<|0.0001|2-Sided|95.0|19.7|37.5|||McNemar||||
1710594|NCT00830167|3147788|Superiority or Other||Mean Difference (Final Values)|-4.99|Standard Error of the Mean|1.92||0.0049|2-Sided|95.0|-8.77|-1.21||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710595|NCT00830167|3147789|Superiority or Other||Mean Difference (Final Values)|4.98|Standard Error of the Mean|1.88||0.9958|2-Sided|95.0|1.29|8.68||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710596|NCT00830167|3147790|Superiority or Other||Mean Difference (Final Values)|-9.48|Standard Error of the Mean|1.85|<|0.0001|2-Sided|95.0|-13.12|-5.85||The analysis was conducted using 1-sided test with the significance level of 0.025.|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710597|NCT00830167|3147791|Superiority or Other|||||||0.0078||||||The analysis was conducted using 2-sided test with the significance level of 0.05.|Chi-squared|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that there was a difference between the pregabalin and the placebo groups.|
1710598|NCT00830167|3147792|Superiority or Other||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|0.17||0.0046|2-Sided|95.0|-0.78|-0.11||The analysis was conducted using 1-sided test with the significance level of 0.025. Actual significance level was calculated based on O’Brien-Fleming type alpha spending function of Lan and DeMets (1983).|ANCOVA|||The null hypothesis was to assume that there was no difference between the pregabalin and placebo groups. The alternative was that the pregabalin group was superior to the placebo group.|
1710599|NCT00830037|3147821|Superiority or Other||Mean Difference (Net)|0.035||||0.83|2-Sided|95.0|-0.294|0.365||a = 0.05|Mixed Models Analysis|Wald test||The secondary analysis examined the mean change from baseline proteinuria (log protein to creatinine ratio) at 2 years. The between-groups difference in mean change from baseline is reported with a 95% confidence interval and the p-value from the Wald test.|
1710600|NCT00830037|3147822|Superiority or Other||Mean Difference (Net)|-0.35||||0.79|2-Sided|95.0|-2.9|2.3||a = 0.05|Mixed Models Analysis|Wald test||The analysis of the primary outcome was intention to treat, if the patient received at least one dose of the randomized drug (which was the case for each subject). A linear mixed model was used with GFR as the outcome variable. Fixed effects were indicator variables for time (treated as a continuous variable), treatment, and their interaction. Random effects were subject and time with unstructured covariance; statistical inference was made using the maximum likelihood estimator.|
1710601|NCT00830024|3147823|Non-Inferiority or Equivalence|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|95.89||||||90.0|91.67|100.31|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710602|NCT00830024|3147824|Non-Inferiority or Equivalence|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|95.94||||||90.0|91.76|100.3|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710603|NCT00830024|3147825|Non-Inferiority or Equivalence|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Geometric Test/Ref Ratio x 100|98.75||||||90.0|93.35|104.47|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710604|NCT00829998|3147826|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|102.0||||||90.0|97.1|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710605|NCT00829998|3147827|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|102.0||||||90.0|97.1|107.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710606|NCT00829998|3147828|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|97.4||||||90.0|89.4|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710607|NCT00829985|3147830|Superiority or Other||Treatment Effect|5.4||||0.09|2-Sided|95.0|-0.77|11.51|||Mixed Models Analysis||Estimated value and associated confidence interval represent the treatment effect: change in the extract group (4.0) minus change in the placebo group (-1.3).||
1710608|NCT00829985|3147831|Superiority or Other||Treatment Effect|0.37||||0.37|2-Sided|95.0|-4.89|12.99|||Mixed Models Analysis||Estimated value and associated confidence interval represent the treatment effect: change in the extract group (4.7) minus change in the placebo group (0.7).||
1710609|NCT00829985|3147832|Superiority or Other||Risk Ratio, log|1.13||||0.088|2-Sided|95.0|0.98|1.32|||Mixed Models Analysis||The estimated value and associated confidence interval represent the ratio of baseline-to-post-baseline change in the placebo group (denominator = 0.93) vs. the extract group (numerator = 1.06).||
1710610|NCT00829985|3147833|Superiority or Other||Risk Ratio, log|1.92|||<|0.0001|2-Sided|95.0|1.51|2.45|||Mixed Models Analysis||The estimated value and associated confidence interval represent the ratio of baseline-to-post-baseline change in the placebo group (denominator = 1.12) vs. the extract group (numerator = 2.16).||
1710611|NCT00829933|3147839|Superiority or Other||Cox Proportional Hazard|7.7|||||2-Sided|95.0|-2.7|18.1|||||||
1710612|NCT00829933|3147839|Superiority or Other||Cox Proportional Hazard|2.4|||||2-Sided|95.0|-7.6|12.3|||||||
1710613|NCT00829933|3147839|Superiority or Other|||||||0.32|||||||Chi-squared||||
1710614|NCT00829933|3147839|Superiority or Other||Cox Proportional Hazard|-1.5|||||2-Sided|95.0|-11.2|8.1|||||||
1710615|NCT00829933|3147839|Superiority or Other|||||||0.077|||||||Chi-squared||||
1710616|NCT00829933|3147839|Superiority or Other|||||||0.429|||||||Chi-squared|||For the incidence of bleeding events, paired comparison between the DU-176b groups was performed using the χ2 test.|
1710618|NCT00829868|3147841|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|101.0||||||90.0|97.5|106.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710619|NCT00829868|3147842|Non-Inferiority or Equivalence|Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.|Ratio of Geometric Means|109.0||||||90.0|99.3|120.0|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710620|NCT00829790|3147849|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|116.7||||||90.0|109.89|123.92|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710621|NCT00829790|3147850|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|117.16||||||90.0|110.44|124.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710622|NCT00829790|3147851|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|114.49||||||90.0|109.25|119.98|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710623|NCT00829764|3147852|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|98.46||||||90.0|94.78|102.28|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710624|NCT00829764|3147853|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|97.75||||||90.0|93.98|101.67|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710625|NCT00829764|3147854|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|93.52||||||90.0|88.49|98.83|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710626|NCT00829712|3147868|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.94||||||90.0|96.08|103.95|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710627|NCT00829712|3147869|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|99.05||||||90.0|95.08|103.19|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710628|NCT00829712|3147870|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.95||||||90.0|94.02|108.39|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710629|NCT00829673|3147873|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.5||||||90.0|97.09|104.03|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710630|NCT00829673|3147874|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.74||||||90.0|97.3|104.29|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710631|NCT00829673|3147875|Non-Inferiority or Equivalence|The ANOVA model containing factors for sequence of products, subjects within sequence, periods, and products was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|107.82||||||90.0|100.24|115.98|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710632|NCT00829621|3147876|Superiority or Other||||||=|0|||||||t-test, 1 sided||||
1710660|NCT00829413|3147900|Superiority or Other||Difference in Specificity (%)|7.9|||<|0.138|2-Sided|95.0|-2.4|18.2|||McNemar||||
1710633|NCT00829530|3147877|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.62||||||90.0|97.8|103.52|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1710634|NCT00829530|3147878|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|98.85||||||90.0|91.95|106.27|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1710635|NCT00829530|3147879|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|95.24||||||90.0|90.13|100.63|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710636|NCT00829530|3147880|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|94.96||||||90.0|89.77|100.45|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710637|NCT00829530|3147881|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|88.87||||||90.0|80.31|98.34|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710638|NCT00829504|3147882|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|102.1||||||90.0|95.64|109.0|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710639|NCT00829504|3147883|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|101.76||||||90.0|95.45|108.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710640|NCT00829504|3147884|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|100.16||||||90.0|95.5|105.04|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710641|NCT00829452|3147885|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|97.59||||||90.0|94.62|100.66|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1710642|NCT00829452|3147886|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|98.78||||||90.0|89.34|109.23|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1710643|NCT00829452|3147887|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|96.98||||||90.0|92.73|101.42|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710644|NCT00829452|3147888|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|95.34||||||90.0|90.82|100.09|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710645|NCT00829452|3147889|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|96.03||||||90.0|89.11|103.49|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710646|NCT00829426|3147891|Non-Inferiority or Equivalence|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Ratio of Geometric Means|93.92||||||90.0|91.47|96.44|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710647|NCT00829426|3147892|Non-Inferiority or Equivalence|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Ratio of Geometric Means|92.88||||||90.0|90.34|95.48|||||Bioequivalence is established when 90% Confidence Interval falls within 80 - 125||
1710648|NCT00829426|3147893|Non-Inferiority or Equivalence|An analysis of variance (ANOVA) was performed on each of the pharmacokinetic parameters using SAS® software.|Ratio of Geometric Means|102.56||||||90.0|98.74|106.52|||||Bioequivalence is established when 90% Confidence Interval falls withi 80-125.||
1710649|NCT00829413|3147897|Superiority or Other||||||<|0.0001|||||||Wald Test||||
1710650|NCT00829413|3147897|Superiority or Other||||||<|0.0001|||||||Wald Test||||
1710651|NCT00829413|3147897|Superiority or Other||||||<|0.0001|||||||Wald Test||||
1710652|NCT00829413|3147898|Superiority or Other||||||<|0.0001|||||||Wald Test||||
1710653|NCT00829413|3147898|Superiority or Other||||||<|0.0001|||||||Wald Test||||
1710654|NCT00829413|3147898|Superiority or Other||||||<|0.0001|||||||Wald Test||||
1710664|NCT00829387|3147902|Superiority or Other||Mean Difference (Final Values)|-4.16||||0.15|2-Sided|95.0|-9.86|1.55|||linear mixed model|||baseline to 36 weeks post-baseline|
1710665|NCT00829387|3147903|Superiority or Other||Mean Difference (Final Values)|-0.92||||0.03|2-Sided|95.0|-1.76|-0.07|||linear mixed model|||baseline to 36 weeks post-baseline|
1710666|NCT00829387|3147904|Superiority or Other||Mean Difference (Final Values)|0.01||||0.98|2-Sided|95.0|-1.03|1.06|||linear mixed model|||baseline to 12 weeks comparison|
1710667|NCT00829387|3147905|Superiority or Other||Mean Difference (Final Values)|-2.35||||0.31|2-Sided|95.0|-7.02|2.32|||Linear mixed model|||baseline to 12 weeks post-baseline|
1710668|NCT00829387|3147906|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.4|2-Sided|95.0|-1.15|0.47|||linear mixed model|||baseline to 36 weeks post-baseline|
1710669|NCT00829387|3147907|Superiority or Other||Median Difference (Final Values)|-0.39||||0.47|2-Sided|95.0|-1.47|0.69|||Linear mixed model||||
1710670|NCT00829309|3147908|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|96.3||||||90.0|85.34|108.66|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710671|NCT00829309|3147909|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|90.98||||||90.0|85.23|97.12|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710672|NCT00829309|3147910|Non-Inferiority or Equivalence|Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.|Geometric Test/Ref Ratio x 100|98.45||||||90.0|80.08|121.03|||||Bioequivalence is established when 90% Confidence Interval falls within 80-125.||
1710673|NCT00829244|3147919|Superiority or Other||Percent difference|0.6|||||2-Sided|95.0|-13.5|14.6|||||||
1710674|NCT00829244|3147920|Superiority or Other||Mean Difference (Final Values)|0.93|Standard Error of the Mean|0.78||0.235|2-Sided|95.0|-0.61|2.47|||ANOVA||||
1710675|NCT00829244|3147922|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|6.6||0.926|2-Sided|95.0|-12.3|13.6|||ANOVA||||
1710676|NCT00829244|3147924|Superiority or Other||Percent difference|3.6|||||2-Sided|95.0|-11.0|18.2|||||||
1710677|NCT00829244|3147926|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.2||0.933|2-Sided|95.0|-0.4|0.5|||ANOVA||||
1710678|NCT00829244|3147927|Superiority or Other||Mean Difference (Final Values)|-45.6|Standard Error of the Mean|4.12|<|0.001|2-Sided|95.0|-53.75|-37.46|||ANOVA||||
1710679|NCT00829244|3147928|Superiority or Other||Mean Difference (Final Values)|-511.37|Standard Error of the Mean|64.52|<|0.001|2-Sided|95.0|-638.78|-383.96|||ANOVA||||
1710680|NCT00829244|3147929|Superiority or Other||Mean Difference (Final Values)|-1.7|Standard Error of the Mean|0.8||0.037|2-Sided|95.0|-3.3|-0.1|||ANOVA|||The null hypothesis was that the difference between the mean number of oocytes [CONSORT calculator dosing – Standard dosing] was less than or equal to [=<] (-3). The alternate hypothesis was that the difference was greater than [>] (-3).|
1710681|NCT00829179|3147930|Superiority or Other||Difference in Mean|11.0|Standard Deviation|13.3||0.005||95.0|||||Sign test||||
1710682|NCT00829166|3147931|Superiority or Other||Hazard Ratio (HR)|0.796||||0.0121|2-Sided|95.0|0.667|0.951|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or >1), and visceral/ non-visceral disease.|
1710683|NCT00829166|3147933|Superiority or Other||Hazard Ratio (HR)|0.703|||<|0.0001|2-Sided|95.0|0.602|0.82|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or >1), and visceral/ non-visceral disease.|
1710684|NCT00829166|3147935|Superiority or Other||Difference in Clinical Benefit Rate|14.0|||||2-Sided|95.0|7.0|20.9|||||The 95% CI for the difference in clinical benefit rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the normal approximation method.||
1710685|NCT00829166|3147937|Superiority or Other||Difference in Objective Response Rates|12.7||||0.0002|2-Sided|95.0|6.0|19.4|||Mantel-Haenszel chi-squared test||The 95% CI for the difference in objective response rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the approximate normal method.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or >1), and visceral/ non-visceral disease.|
1710686|NCT00829166|3147938|Superiority or Other||Hazard Ratio (HR)|0.658|||<|0.0001|2-Sided|95.0|0.56|0.774|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or >1), and visceral/ non-visceral disease.|
1710687|NCT00829166|3147942|Superiority or Other||Hazard Ratio (HR)|0.749||||0.0003|2-Sided|95.0|0.639|0.877|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or >1), and visceral/ non-visceral disease.|
1710688|NCT00829166|3147944|Superiority or Other||Hazard Ratio (HR)|0.682||||0.0006|2-Sided|95.0|0.548|0.849|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or >1), and visceral/ non-visceral disease.|
1710689|NCT00829166|3147946|Superiority or Other||Hazard Ratio (HR)|0.65|||<|0.0001|2-Sided|95.0|0.549|0.771|||Log Rank||HR (relative to Lapatinib + Capecitabine) was estimated by Cox regression.|Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or greater than [>] 1), and visceral/ non-visceral disease.|
1710690|NCT00828711|3148012|Superiority or Other||Median Difference (Net)|-368.0||||0.007|2-Sided|95.0|||||Log Rank||MVI 200 - MVI 100|Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdraw consent prior to delivery will be censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.|
1710691|NCT00828711|3148014|Superiority or Other||Difference in Proportions|-22.09|||<|0.001|2-Sided|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100||
1710692|NCT00828711|3148015|Superiority or Other||Difference in Proportions|2.37||||0.65|2-Sided|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100||
1710693|NCT00828711|3148016|Superiority or Other||Difference in Proportions|-8.46||||0.153|2-Sided|95.0|||||Fisher Exact||MVI 200 - MVI 100||
1710694|NCT00828711|3148018|Superiority or Other||Median Difference (Net)|-563.0||||0.018|2-Sided|95.0|||||Log Rank||MVI 200 - MVI 100|Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.|
1710695|NCT00828711|3148019|Superiority or Other||Difference in Proportions|12.2||||0.057|2-Sided|95.0|||||Cochran-Mantel-Haenszel|Adjusted for site effect|MVI 200 - MVI 100|The primary objective of this study is to compare the efficacy of MVI 100 and MVI 200 based on the proportion of vaginal deliveries within 24 hours. A minimum sample size of approximately 120 subjects per arm would provide 84 subjects per arm with vaginal delivery, which would ensure >80% power (with two-sided alpha of 5%) to detect a 20% improvement in the proportion of women delivering vaginally within 24 hours|
1710696|NCT00828568|3148027|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1710697|NCT00828568|3148027|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1710698|NCT00828568|3148029|Non-Inferiority or Equivalence|The 90% confidence limit around the difference in proportion of patients considered a Treatment Success between test and reference products was calculated using Blackwelder’s method with Yate’s continuity correction. If the 90% confidence interval for the test to reference ratio for the primary endpoint was within -0.20 to +0.20, then the test product would have been declared therapeutically equivalent to the reference product.|Mean Difference (Final Values)|4.85||||||90.0|-5.37|15.08|||||||
1710699|NCT00828516|3148032|Superiority or Other||Mean Difference (Final Values)|1.32|Standard Deviation|0.94|<|0.001||95.0||||There will be no improvement in MYMOP profile score after 12 treatments|t-test, 2 sided||"MYMOP uses a 7-point scale, from 0 to 6, with 0 as good as it can be, and 6 as bad as it can be. Higher values represent a worse outcome."||
1710700|NCT00828516|3148033|Superiority or Other||Mean Difference (Final Values)|1.51|Standard Deviation|0.96|<|0.001||95.0||||This was not adjusted for multiple comparisons|t-test, 2 sided||"MYMOP uses a 7-point scale, from 0 to 6, with 0 as good as it can be, and 6 as bad as it can be. Higher values represent a worse outcome."|There will be no improvement in MYMOP profile score after 6 acupuncture treatments.|
1710701|NCT00828347|3148052|Superiority or Other|||||||0.036|||||||Fisher Exact||||
1710702|NCT00828321|3148053|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|97.45||||||90.0|94.66|100.32|||||This analysis was for informational purposes only and was not used to establish bioequivalence.||
1710703|NCT00828321|3148054|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|98.52||||||90.0|92.63|104.79|||||This analysis was for informational purposes and was not used to establish bioequivalence.||
1710704|NCT00828321|3148055|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|102.22||||||90.0|96.34|108.58|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710705|NCT00828321|3148056|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|102.22||||||90.0|96.21|108.6|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710706|NCT00828321|3148057|Non-Inferiority or Equivalence|The ANOVA model was utilized in comparing the effects between the test and reference products. Differences were declared statistically significant at the 5% level (p<0.05).|Ratio of the T/R geometric mean x 100|94.16||||||90.0|85.08|104.21|||||Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference and test product fall within the interval of 80-125%.||
1710707|NCT00828191|3148070|Superiority or Other||Risk Difference (RD)|-2.0||||0.62|2-Sided|95.0|-8.8|4.8|||Fisher Exact||||
1710708|NCT00828191|3148071|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|1.48||0.54|2-Sided|95.0|-7.6|4.0|||ANOVA||||
1710709|NCT00828191|3148072|Non-Inferiority or Equivalence|The null hypothesis (H0) was tested against the alternative by calculating a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower bound of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and the test group considered not inferior to the control treatment.|Difference in pregnancy rates|-2.5||||0.52|2-Sided|95.0|-9.4|4.4|||Fisher Exact|||"The non -inferiority hypothesis to be tested for the primary endpoint was that the ongoing pregnancy rate (oPR) in the test group (Pe)was lower than the oPR in the control group (Pc)against the alternative one that the oPR in the test group was equal to or higher than the oPR in the control group.~H0 : Pc>= Pe + d(-10%) H1 : Pc< Pe + d(-10%)"|
1710710|NCT00828178|3148074|Superiority or Other|||||||0.1801||||||This Statistical Analysis applies category SELENA-SLEDAI|t-test, 2 sided||||
1710711|NCT00828178|3148075|Superiority or Other|||||||0.87|||||||t-test, 2 sided|||Statistical analysis system (SAS) software was used (SAS Institute Inc. Cary, North Carolina, SAS 9.2). Baseline demographic and clinical characteristics were summarized using appropriate descriptive statistics and compared across treatment groups using Chi-square. Two-sample t tests were used in the statistical analysis of the FMD outcomes. ANCOVA was used to compare the groups with respect to changes in clinical variables adjusting for baseline values.|
1710712|NCT00828139|3148079|Superiority or Other||Hazard Ratio (HR)|1.51|||||2-Sided|90.0|1.08|2.1||||||Hazard Ratio was evaluated using log-rank test.|
1710713|NCT00828139|3148079|Superiority or Other||Hazard Ratio (HR)|1.32|||||2-Sided|90.0|0.91|1.92||||||Hazard Ratio was evaluated using a logrank test.|
1710714|NCT00828139|3148079|Superiority or Other||3-month PFS|0.1|||||2-Sided|90.0|0.04|0.2|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.|
1710715|NCT00828139|3148079|Superiority or Other||3-month PFS|0.27|||||2-Sided|90.0|0.18|0.39|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.|
1710716|NCT00828139|3148079|Superiority or Other||3-month PFS|0.15|||||2-Sided|90.0|0.07|0.27|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier.|
1710717|NCT00828139|3148079|Superiority or Other||3-month PFS|0.24|||||2-Sided|90.0|0.14|0.37|||||The estimated value corresponds to the probability of PFS at month 3.|3-month PFS was estimated using the method of Kaplan-Meier. The 3-month PFS estimated value corresponds to the probability of PFS at month 3.|
1710718|NCT00828061|3148088|Superiority or Other||Mean Difference (Final Values)|0.89||||0.537||95.0|-15.48|17.26||1-sided, alpha = 0.05|ANOVA||||
1710719|NCT00828061|3148089|Superiority or Other||Geometric Mean Fold Difference|0.07|||<|0.001||95.0|0.03|0.15||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.|||
1710720|NCT00828061|3148089|Superiority or Other||Geometric Mean Fold Difference|0.25|||<|0.002||95.0|0.12|0.54||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.|||
1710721|NCT00827983|3148093|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|1.33||0.85|2-Sided|95.0|-4.7|5.8|||t-test, 2 sided||||
1710722|NCT00827983|3148094|Superiority or Other||Risk Difference (RD)|-3.1||||0.37|2-Sided|95.0|-9.87|3.68|||Chi-squared||||
1710723|NCT00827983|3148095|Non-Inferiority or Equivalence|The null hypothesis (H0) was tested against the alternative by calculating a two-sided 95% confidence interval for the difference in ongoing pregnancy rates. If the lower bound of the 95% confidence interval was greater than the non-inferiority limit (-10.0%), the null hypothesis was rejected and the test group considered not inferior to the control treatment.|Difference in pregnancy rates|-3.1||||0.37|2-Sided|95.0|-9.9|3.7|||Chi-squared|||"The non -inferiority hypothesis to be tested for the primary endpoint was that the ongoing pregnancy rate (oPR) in the test group (Pe)was lower than the oPR in the control group (Pc)against the alternative one that the oPR in the test group was equal to or higher than the oPR in the control group.~H0 : Pc>= Pe + d(-10%) H1 : Pc< Pe + d(-10%)"|
1710724|NCT00827931|3148105|Superiority or Other|||||||0.701|||||||Fisher Exact|||Fisher’s exact test was used at 5% level of significance.|
1710725|NCT00827931|3148106|Superiority or Other||Mean Difference (Final Values)|-417.7|Standard Error of the Mean|152.51||0.01|2-Sided|95.0|-729.4|-106.1|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.|
1710726|NCT00827931|3148107|Superiority or Other||Mean Difference (Final Values)|-183.5|Standard Error of the Mean|239.19||0.452|2-Sided|95.0|-672.6|305.5|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.|
1710727|NCT00827931|3148108|Superiority or Other||Mean Difference (Final Values)|-83.6|Standard Error of the Mean|147.61||0.579|2-Sided|95.0|-386.5|219.3|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.|
1710728|NCT00827931|3148109|Superiority or Other||Mean Difference (Final Values)|-99.9|Standard Error of the Mean|131.99||0.46|2-Sided|95.0|-371.4|171.5|||t-test, 2 sided|||The null hypothesis applicable to the efficacy analyses was that there was no difference between tranexamic acid plus standard care compared to standard care alone. The alternative hypothesis was that there was a difference.|
1710729|NCT00827918|3148110|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.8567|2-Sided|95.0|-2.0|1.6|||Constrained longitudinal data analysis||||
1710730|NCT00827918|3148110|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.5953|2-Sided|95.0|-2.0|1.2|||Constrained longitudinal data analysis||||
1710731|NCT00827918|3148111|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.2406|2-Sided|95.0|-3.6|0.9|||Constrained longitudinal data analysis||||
1710732|NCT00827918|3148111|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9937|2-Sided|95.0|-2.0|2.0|||Constrained longitudinal data analysis||||
1710733|NCT00827918|3148112|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9486|2-Sided|95.0|-0.4|0.4|||Constrained longitudinal data analysis||||
1710734|NCT00827918|3148112|Superiority or Other||Mean Difference (Final Values)|0.0||||0.8199|2-Sided|95.0|-0.4|0.3|||Constrained longitudinal data analysis||||
1710735|NCT00827918|3148113|Superiority or Other||Odds Ratio (OR)|2.2||||0.0653|2-Sided|95.0|0.95|5.09|||Generalized linear mixed analysis model||||
1710736|NCT00827918|3148113|Superiority or Other||Odds Ratio (OR)|1.28||||0.4976|2-Sided|95.0|0.62|2.64|||Generalized linear mixed analysis model||||
1710737|NCT00827918|3148116|Superiority or Other||Mean Difference (Final Values)|-4.3||||0.2534|2-Sided|95.0|-11.7|3.1|||Difference in the Least Squares Mean||||
1710738|NCT00827918|3148116|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.859|2-Sided|95.0|-7.0|5.8|||Difference in the Least Squares Mean||||
1710739|NCT00827372|3148184|Superiority or Other|||||||0.0143|||||||t-test, 2 sided|||A Paired T-Test was used for the difference in the impedance ratio from the second baseline to cycle 2, day 1|
1710740|NCT00827372|3148185|Superiority or Other|||||||0.0061|||||||t-test, 2 sided|||A Paired T-Test was used to compare the IFP affected at first versus affected at last reading.|
1710767|NCT00826280|3148249|Superiority or Other||||||<|0.001||||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1711154|NCT00824265|3148539|Superiority or Other|||||||0.0003|||||||Cochran-Mantel-Haenszel||||
1710741|NCT00827372|3148186|Superiority or Other|||||||0.0658|||||||t-test, 2 sided|||With a sample size of 14 evaluable subjects, we will have 80% power to detect a change in excess arm volume of .8 standard deviations using a two-sided paired t-test. We will have 90% power to detect a difference of .9 standard deviations. A Paired T-Test was used to test the difference in arm volume from the second baseline measurement to Cycle 2 only.|
1710742|NCT00827242|3148189|Superiority or Other|||||||0.5||||||The p-value associates with mean difference of changes from baseline to 12 weeks between treatment groups for PVR volume. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ranked ANOVA||||
1710743|NCT00827242|3148192|Superiority or Other|||||||0.3||||||The p-value associates with mean difference of changes from baseline to 12 weeks between treatment groups for Qmax. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ranked ANOVA||||
1710744|NCT00827242|3148193|Superiority or Other||Mean Difference (Final Values)|4.7|Standard Error of the Mean|1.12|<|0.001||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IIEF-EF domain score. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA||||
1710745|NCT00827242|3148194|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|0.6||0.003||95.0||||The p-value associates with LS Mean difference of changes from baseline to 4 weeks between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA||||
1710746|NCT00827242|3148195|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.49||0.146||95.0||||The p-value associates with LS Mean difference of changes from baseline to 1 week between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA||||
1710747|NCT00827242|3148196|Superiority or Other|||||||0.009||||||The p-value associates with difference between treatment groups for the 7 response categories.|Cochran-Mantel-Haenszel|Results were adjusted for baseline LUTS severity (moderate [total IPSS < 20]; severe [total IPSS >= 20]|||
1710748|NCT00827242|3148197|Superiority or Other|||||||0.021||||||The p-value associates with difference between treatment groups for the 7 response categories.|Cochran-Mantel-Haenszel|Results were adjusted for baseline LUTS severity (moderate [total IPSS < 20]; severe [total IPSS >= 20]|||
1710749|NCT00827242|3148198|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.15||0.013||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS QoL Index. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA||||
1710750|NCT00827242|3148199|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.11||0.233||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS nocturia question. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA||||
1710751|NCT00827242|3148200|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.43||0.02||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS voiding subscore. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA||||
1710752|NCT00827242|3148201|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.3||0.002||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS storage subscore. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA||||
1710753|NCT00827242|3148202|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.3||0.057||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for BII. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA||||
1710754|NCT00827242|3148203|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.26||0.029||95.0||||The p-value associates with LS Mean difference of changes from baseline to 4 weeks between treatment groups for BII. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA||||
1710755|NCT00827242|3148204|Superiority or Other||Mean Difference (Final Values)|-1.9|Standard Error of the Mean|0.66||0.004||95.0||||The p-value associates with LS Mean difference of changes from baseline to 12 weeks between treatment groups for IPSS. Under the pre-specified fixed sequence testing procedure, the significance level of 0.05 is used for assessment.|ANCOVA||||
1710756|NCT00826943|3148229|Superiority or Other|||||||0.42|||||||Wilcoxon (Mann-Whitney)||||
1710757|NCT00826943|3148229|Superiority or Other|||||||0.54|||||||Wilcoxon (Mann-Whitney)||||
1710758|NCT00826943|3148229|Superiority or Other|||||||0.14||||||The threshold for significance was p < 0.05.|Wilcoxon (Mann-Whitney)||||
1710759|NCT00826943|3148230|Superiority or Other|||||||0.52||||||The threshold for significance was p < 0.05.|Wilcoxon (Mann-Whitney)||||
1710760|NCT00826943|3148230|Superiority or Other|||||||0.8||||||The threshold for significance was p < 0.05.|Wilcoxon (Mann-Whitney)||||
1710761|NCT00826943|3148230|Superiority or Other|||||||0.27||||||The threshold for significance was p < .05.|Wilcoxon (Mann-Whitney)||||
1710762|NCT00826943|3148231|Superiority or Other|||||||0.45|||||||Wilcoxon (Mann-Whitney)||||
1710763|NCT00826943|3148231|Superiority or Other|||||||0.11||||||The threshold for significance was p < 0.05.|Wilcoxon (Mann-Whitney)||||
1710764|NCT00826943|3148231|Superiority or Other|||||||0.03||||||The threshold for significance was p < 0.05.|Wilcoxon (Mann-Whitney)||||
1710765|NCT00826618|3148238|Superiority or Other|||||||0.0015|||||||t-test, 2 sided|||Compare final visual acuity to baseline visual acuity|
1710766|NCT00826280|3148249|Superiority or Other|||||||0.4246||||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710800|NCT00825916|3148293|Superiority or Other|||||||0.85||||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)||||
1710768|NCT00826280|3148249|Superiority or Other||||||<|0.001||||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710769|NCT00826280|3148249|Superiority or Other||||||<|0.001||||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710770|NCT00826280|3148250|Superiority or Other|||||||0.5654||||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710771|NCT00826280|3148250|Superiority or Other|||||||0.0016||||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710772|NCT00826280|3148250|Superiority or Other|||||||0.0089||||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710773|NCT00826280|3148250|Superiority or Other|||||||0.0037||||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710774|NCT00826280|3148251|Superiority or Other|||||||0.5902||||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710775|NCT00826280|3148251|Superiority or Other||||||<|0.001||||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710776|NCT00826280|3148251|Superiority or Other||||||<|0.0034||||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710777|NCT00826280|3148251|Superiority or Other||||||<|0.0011||||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710778|NCT00826280|3148252|Superiority or Other|||||||0.9328||||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710779|NCT00826280|3148252|Superiority or Other||||||<|0.001||||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710780|NCT00826280|3148252|Superiority or Other||||||<|0.001||||||The unadjusted P-Values for pairwise differences should be used for interpretation only if the treatment effect's P-Value ≤ 0.05.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710781|NCT00826280|3148252|Superiority or Other||||||<|0.001||||||P-Value is from the primary analysis using ANCOVA.|ANCOVA|||P-Value applies to 'Double-Blind - Baseline (Day 5 - Day 3)'.|
1710782|NCT00826202|3148263|Superiority or Other|||||||0.12|||||||Mixed Models Analysis|cohen's d=0.93|||
1710783|NCT00826202|3148264|Superiority or Other|||||||0.03|||||||Mixed Models Analysis|Cohen's d=0.68|||
1710784|NCT00826202|3148265|Superiority or Other|||||||0.056|||||||t-test, 2 sided|cohen's d=0.84|||
1710785|NCT00826202|3148266|Superiority or Other|||||||0.07|||||||Mixed Models Analysis|cohen's d= 0.67|||
1710786|NCT00826176|3148269|Non-Inferiority or Equivalence|Equivalence between the two subject populations was to be claimed in the event that the two-sided 95% confidence interval was entirely within the interval ranging from -60 to +60 seconds.|median difference (seconds)|49.0||||||95.0|30.0|72.0|||||The estimated median difference (Chinese minus Caucasian) in time to recovery of the T4/T1 ratio to 0.9.||
1710787|NCT00826176|3148269|Superiority or Other||upper limit of tolerance interval (min.)|3.2||||||95.0|||||||The tolerance interval (TI) refers to a fixed proportion (in this trial set to 95%) of the population with a stated confidence (in this trial, 95%). Efficacy was to be claimed in case the upper limit of TI was below the prespecified margin of 10 min.||
1710788|NCT00826176|3148269|Superiority or Other||upper limit of tolerance interval (min.)|6.4||||||95.0|||||||The tolerance interval (TI) refers to a fixed proportion (in this trial set to 95%) of the population with a stated confidence (in this trial, 95%). Efficacy was to be claimed in case the upper limit of TI was below the prespecified margin of 10 min.||
1710789|NCT00826111|3148279|Superiority or Other||Mean Difference (Final Values)|-1.7|Standard Error of the Mean|3.78||0.66|2-Sided|95.0|-10.31|6.91|||t-test, 2 sided||||
1710790|NCT00826111|3148280|Superiority or Other||Mean Difference (Net)|0.6|Standard Error of the Mean|4.06||0.89|2-Sided|95.0|-9.31|10.51|||t-test, 2 sided||||
1710791|NCT00826111|3148281|Superiority or Other||Mean Difference (Final Values)|7.35|Standard Error of the Mean|3.94||0.1|2-Sided|95.0|-1.76|16.46|||t-test, 2 sided||||
1710792|NCT00826111|3148282|Superiority or Other||Mean Difference (Final Values)|0.0056|Standard Error of the Mean|0.0042||0.21|2-Sided|95.0|-0.0037|0.1481|||t-test, 2 sided||||
1710793|NCT00826111|3148283|Superiority or Other||Mean Difference (Final Values)|0.0048|Standard Error of the Mean|0.005||0.37|2-Sided|95.0|-0.0077|0.0174|||t-test, 2 sided||||
1710794|NCT00826111|3148284|Superiority or Other||Mean Difference (Final Values)|0.71|Standard Error of the Mean|0.515||0.29|2-Sided|95.0|-1.35|2.77|||t-test, 2 sided||||
1710795|NCT00826111|3148285|Superiority or Other||Mean Difference (Final Values)|-0.0222|Standard Error of the Mean|0.0128||0.16|2-Sided|95.0|-0.58|0.0136|||t-test, 2 sided||||
1710796|NCT00826111|3148286|Superiority or Other||Mean Difference (Final Values)|-0.031|Standard Error of the Mean|0.112||0.79|2-Sided|95.0|-0.286|0.224|||t-test, 2 sided||||
1710797|NCT00826111|3148287|Superiority or Other||Mean Difference (Final Values)|0.0085|Standard Error of the Mean|0.0534||0.88|2-Sided|95.0|-0.139|0.0122|||t-test, 2 sided||||
1710798|NCT00826007|3148290|Superiority or Other||Odds Ratio (OR)|0.18|Standard Error of the Mean|0.36|<|0.001|2-Sided|95.0|0.09|0.18|||Regression, Logistic||||
1710799|NCT00825916|3148293|Superiority or Other|||||||0.83||||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)||||
1711229|NCT00822523|3148789|Superiority or Other||r value|0.4||||0.505|2-Sided||||||Spearman Correlation Test|||Month 4|
1710801|NCT00825916|3148293|Superiority or Other|||||||0.44||||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)||||
1710802|NCT00825916|3148293|Superiority or Other|||||||0.6||||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)||||
1710803|NCT00825916|3148293|Superiority or Other|||||||0.76||||||For this early phase study, no adjustment was used.|Wilcoxon (signed rank)||||
1710804|NCT00825916|3148293|Superiority or Other|||||||0.95|||||||Wilcoxon (signed rank)|For this early phase study, no adjustment was used.|||
1710805|NCT00825916|3148294|Superiority or Other|||||||0.69|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710806|NCT00825916|3148294|Superiority or Other|||||||0.92|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710807|NCT00825916|3148294|Superiority or Other|||||||0.63|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710808|NCT00825916|3148294|Superiority or Other|||||||0.76|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710809|NCT00825916|3148294|Superiority or Other|||||||0.59|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710810|NCT00825916|3148294|Superiority or Other|||||||0.95|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710811|NCT00825916|3148294|Superiority or Other|||||||0.83|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710812|NCT00825916|3148294|Superiority or Other|||||||0.15|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710813|NCT00825916|3148294|Superiority or Other|||||||0.98|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710814|NCT00825916|3148294|Superiority or Other|||||||0.34|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710815|NCT00825916|3148295|Superiority or Other|||||||1|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710816|NCT00825916|3148295|Superiority or Other|||||||0.69|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710817|NCT00825916|3148295|Superiority or Other|||||||0.59|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710818|NCT00825916|3148295|Superiority or Other|||||||0.74|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710819|NCT00825916|3148296|Superiority or Other|||||||0.49|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710820|NCT00825916|3148296|Superiority or Other|||||||0.92|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710821|NCT00825916|3148296|Superiority or Other|||||||0.086|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710822|NCT00825916|3148296|Superiority or Other|||||||0.078|||||||Wilcoxon (rank sum)|For this early phase study, no adjustment was used.|||
1710823|NCT00825825|3148297|Superiority or Other|||||||0.0241|||||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.|
1710824|NCT00825825|3148298|Superiority or Other|||||||6.33e-05|||||||Mixed Models Analysis|||This analysis is a comparison between the placebo and citalopram medication periods.|
1710825|NCT00825825|3148299|Superiority or Other|||||||0.00124|||||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and placebo medication periods.|
1710826|NCT00825825|3148300|Superiority or Other|||||||0.0279|||||||Mixed Models Analysis|||This analysis is a comparison between the citalopram and placebo medication periods.|
1710827|NCT00825825|3148301|Superiority or Other|||||||9.36e-06|||||||Mixed Models Analysis|||This analysis is a comparison between the citalopram and placebo medication periods.|
1710828|NCT00825825|3148302|Superiority or Other|||||||1.62e-05|||||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.|
1710829|NCT00825825|3148303|Superiority or Other|||||||0.000704|||||||Mixed Models Analysis|||This analysis is a comparison between the escitalopram and citalopram medication periods.|
1710830|NCT00825812|3148305|Non-Inferiority or Equivalence|Equivalence was considered if the 97.5% confidence interval (CI) for median difference in recovery time (T4/T1 ratio to 0.9) was within the pre-specified range of -60 to +60 seconds.|median difference (seconds)|7.0||||||97.5|-5.0|21.0|||||Estimated median difference (Chinese - Caucasian) in seconds for the time to recovery of the T4/T1 ratio to 0.9 (after sugammadex).|A key secondary analysis was the comparison for equivalence between Chinese subjects and Caucasian subjects.|
1710831|NCT00825812|3148305|Superiority or Other||ratio of geometric mean time to recovery|4.8||||||97.5|3.7|6.0|||||Ratio of time to recovery of 0.9 T4/T1 ratio (neostigmine time / sugammadex time).|A key secondary analysis was the comparison of the two treatments among Caucasian subjects.|
1710832|NCT00825812|3148305|Superiority or Other||ratio of geometric mean time to recovery|5.7||||||95.0|4.9|6.6|||||Ratio of time to recovery of 0.9 T4/T1 ratio (neostigmine time / sugammadex time).|The primary analysis was the comparison of the two treatments among Chinese subjects.|
1710833|NCT00825786|3148306|Superiority|||||||0.88|||||||ANCOVA||||
1710834|NCT00825786|3148307|Superiority|||||||0.15|||||||Log Rank||||
1710835|NCT00825786|3148308|Superiority|||||||0.34|||||||ANCOVA||||
1710836|NCT00825786|3148309|Superiority|||||||0.6|||||||ANCOVA||||
1710837|NCT00825786|3148310|Superiority|||||||0.66|||||||Log Rank||||
1710838|NCT00825786|3148311|Superiority|||||||0.02|||||||Log Rank||||
1710839|NCT00825786|3148312|Superiority||Hazard Ratio (HR)|0.71||||0.14|2-Sided|95.0|0.46|1.09|||Log Rank||group 2 vs. group 1 (sequential vs combined)||
1710840|NCT00825305|3148338|Non-Inferiority or Equivalence|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 42 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean (day 42)|-0.07|||||2-Sided|95.0|-0.72|0.58|||||Ratio of log2 mean (Zagreb/(Essen) on day 42||
1710867|NCT00824850|3148358|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.0|10.1||||||7vPnC serotype 6B: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710841|NCT00825305|3148338|Non-Inferiority or Equivalence|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 7 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean (day7)|-0.21|||||2-Sided|95.0|-0.77|0.35|||||Ratio of log2 means (Zagreb/Essen) on day 7||
1710842|NCT00825305|3148339|Non-Inferiority or Equivalence|The null hypothesis states that the Zagreb schedule is inferior to the Essen schedule in terms of day 14 antibody titers assuming no difference between the two schedules and the equivalence limit of 1.5 titer levels (log2).|ratio of log2 mean|-0.2|||||2-Sided|95.0|-0.81|0.4|||||Ratio of log2 mean (Zagreb/Essen) on day 14||
1710843|NCT00824850|3148357|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710844|NCT00824850|3148357|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.7|10.6||||||Additional serotype 7F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710845|NCT00824850|3148357|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710846|NCT00824850|3148357|Superiority or Other||difference in proportions|3.3|||||2-Sided|95.0|-8.6|17.2||||||Additional serotype 5: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710847|NCT00824850|3148357|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.4|10.3||||||Additional serotype 3: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710848|NCT00824850|3148357|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.0|10.1||||||Additional serotype 1: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710849|NCT00824850|3148357|Superiority or Other||difference in proportions|3.0|||||2-Sided|95.0|-9.1|16.6||||||7vPnC serotype 23F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710850|NCT00824850|3148357|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.1|10.5||||||7vPnC serotype 19F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710851|NCT00824850|3148357|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.0|10.1||||||7vPnC serotype 18C: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710852|NCT00824850|3148357|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.3||||||7vPnC serotype 14: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710853|NCT00824850|3148357|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710854|NCT00824850|3148357|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.2|10.6||||||7vPnC serotype 6B: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710855|NCT00824850|3148357|Superiority or Other||difference in proportions|-2.6|||||2-Sided|95.0|-13.9|8.0||||||7vPnC serotype 4: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710856|NCT00824850|3148358|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710857|NCT00824850|3148358|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.0|10.1||||||Additional serotype 7F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710858|NCT00824850|3148358|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.4|10.3||||||Additional serotype 6A: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710859|NCT00824850|3148358|Superiority or Other||difference in proportions|3.1|||||2-Sided|95.0|-9.3|17.0||||||Additional serotype 5: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710860|NCT00824850|3148358|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 3: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710861|NCT00824850|3148358|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.4|10.3||||||Additional serotype 1: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710862|NCT00824850|3148358|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.0|10.1||||||7vPnC serotype 23F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710863|NCT00824850|3148358|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710864|NCT00824850|3148358|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710865|NCT00824850|3148358|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.4|10.3||||||7vPnC serotype 14: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710866|NCT00824850|3148358|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710868|NCT00824850|3148358|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.2|10.9||||||7vPnC serotype 4: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710869|NCT00824850|3148361|Superiority or Other||ratio of geometric mean titers|0.9|||||2-Sided|95.0|0.46|1.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710870|NCT00824850|3148361|Superiority or Other||ratio of geometric mean titers|1.3|||||2-Sided|95.0|0.65|2.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710871|NCT00824850|3148361|Superiority or Other||ratio of geometric mean titers|1.4|||||2-Sided|95.0|0.8|2.36|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710872|NCT00824850|3148361|Superiority or Other||ratio of geometric mean titers|0.8|||||2-Sided|95.0|0.32|1.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710873|NCT00824850|3148361|Superiority or Other||ratio of geometric mean titers|1.1|||||2-Sided|95.0|0.69|1.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710874|NCT00824850|3148361|Superiority or Other||ratio of geometric mean titers|1.0|||||2-Sided|95.0|0.53|1.77|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710875|NCT00824850|3148361|Superiority or Other||ratio of geometric mean titers|1.4|||||2-Sided|95.0|0.68|2.81|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710876|NCT00824850|3148361|Superiority or Other||ratio of geometric mean titers|0.7|||||2-Sided|95.0|0.28|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710877|NCT00824850|3148361|Superiority or Other||ratio of geometric mean titers|1.1|||||2-Sided|95.0|0.64|1.91|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710878|NCT00824850|3148361|Superiority or Other||ratio of geometric mean titers|0.6|||||2-Sided|95.0|0.38|0.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710879|NCT00824850|3148361|Superiority or Other||ratio of geometric mean titers|0.9|||||2-Sided|95.0|0.54|1.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710880|NCT00824850|3148361|Superiority or Other||ratio of geometric mean titers|1.3|||||2-Sided|95.0|0.77|2.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710881|NCT00824850|3148361|Superiority or Other||ratio of geometric mean titers|0.7|||||2-Sided|95.0|0.35|1.27|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710882|NCT00824850|3148362|Superiority or Other||ratio of geometric mean titers|0.9|||||2-Sided|95.0|0.5|1.63|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710883|NCT00824850|3148362|Superiority or Other||ratio of geometric mean titers|1.1|||||2-Sided|95.0|0.73|1.7|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710884|NCT00824850|3148362|Superiority or Other||ratio of geometric mean titers|0.9|||||2-Sided|95.0|0.55|1.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710885|NCT00824850|3148362|Superiority or Other||ratio of geometric mean titers|0.9|||||2-Sided|95.0|0.36|2.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710886|NCT00824850|3148362|Superiority or Other||ratio of geometric mean titers|1.1|||||2-Sided|95.0|0.82|1.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1711043|NCT00824850|3148374|Superiority or Other||difference in proportions|2.9|||||2-Sided|95.0|-6.7|15.3||||||Additional serotype 1: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1710887|NCT00824850|3148362|Superiority or Other||ratio of geometric mean titers|1.3|||||2-Sided|95.0|0.75|2.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710888|NCT00824850|3148362|Superiority or Other||ratio of geometric mean titers|0.6|||||2-Sided|95.0|0.38|0.85|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710889|NCT00824850|3148362|Superiority or Other||ratio of geometric mean titers|0.6|||||2-Sided|95.0|0.32|1.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710890|NCT00824850|3148362|Superiority or Other||ratio of geometric mean titers|0.8|||||2-Sided|95.0|0.51|1.4|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710891|NCT00824850|3148362|Superiority or Other||ratio of geometric mean titers|0.8|||||2-Sided|95.0|0.56|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710892|NCT00824850|3148362|Superiority or Other||ratio of geometric mean titers|0.8|||||2-Sided|95.0|0.61|1.15|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 9V: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710893|NCT00824850|3148362|Superiority or Other||ratio of geometric mean titers|1.1|||||2-Sided|95.0|0.7|1.73|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 6B: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710894|NCT00824850|3148362|Superiority or Other||ratio of geometric mean titers|0.8|||||2-Sided|95.0|0.5|1.17|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 4: ratio of GMTs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710895|NCT00824850|3148363|Superiority or Other||ratio of geometric mean concentrations|1.11|||||2-Sided|95.0|0.75|1.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710896|NCT00824850|3148363|Superiority or Other||ratio of geometric mean concentrations|1.48|||||2-Sided|95.0|0.9|2.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710897|NCT00824850|3148363|Superiority or Other||ratio of geometric mean concentrations|1.88|||||2-Sided|95.0|1.05|3.35|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710898|NCT00824850|3148363|Superiority or Other||ratio of geometric mean concentrations|1.06|||||2-Sided|95.0|0.68|1.64|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710899|NCT00824850|3148363|Superiority or Other||ratio of geometric mean concentrations|1.44|||||2-Sided|95.0|0.89|2.34|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710900|NCT00824850|3148363|Superiority or Other||ratio of geometric mean concentrations|1.41|||||2-Sided|95.0|0.83|2.39|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710901|NCT00824850|3148363|Superiority or Other||ratio of geometric mean concentrations|1.62|||||2-Sided|95.0|0.97|2.73|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710902|NCT00824850|3148363|Superiority or Other||ratio of geometric mean concentrations|1.58|||||2-Sided|95.0|0.93|2.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710903|NCT00824850|3148363|Superiority or Other||ratio of geometric mean concentrations|0.9|||||2-Sided|95.0|0.51|1.56|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710904|NCT00824850|3148363|Superiority or Other||ratio of geometric mean concentrations|1.96|||||2-Sided|95.0|0.95|4.07|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710905|NCT00824850|3148363|Superiority or Other||ratio of geometric mean concentrations|1.68|||||2-Sided|95.0|1.13|2.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1711145|NCT00824291|3148511|Superiority or Other||Mean Difference (Net)|0.39||||0.145|2-Sided|95.0|-0.13|0.91|||ANCOVA||||
1710906|NCT00824850|3148363|Superiority or Other||ratio of geometric mean concentrations|3.13|||||2-Sided|95.0|1.84|5.32|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710907|NCT00824850|3148363|Superiority or Other||ratio of geometric mean concentrations|2.18|||||2-Sided|95.0|1.26|3.79|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710908|NCT00824850|3148364|Superiority or Other||ratio of geometric mean concentrations|1.06|||||2-Sided|95.0|0.67|1.66|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 19A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710909|NCT00824850|3148364|Superiority or Other||ratio of geometric mean concentrations|1.72|||||2-Sided|95.0|1.05|2.83|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 7F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710910|NCT00824850|3148364|Superiority or Other||ratio of geometric mean concentrations|1.81|||||2-Sided|95.0|0.98|3.34|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 6A: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710911|NCT00824850|3148364|Superiority or Other||ratio of geometric mean concentrations|0.9|||||2-Sided|95.0|0.54|1.52|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 5: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710912|NCT00824850|3148364|Superiority or Other||ratio of geometric mean concentrations|1.25|||||2-Sided|95.0|0.79|1.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 3: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710913|NCT00824850|3148364|Superiority or Other||ratio of geometric mean concentrations|1.7|||||2-Sided|95.0|0.96|3.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|Additional serotype 1: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710914|NCT00824850|3148364|Superiority or Other||ratio of geometric mean concentrations|0.83|||||2-Sided|95.0|0.48|1.43|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 23F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710915|NCT00824850|3148364|Superiority or Other||ratio of geometric mean concentrations|0.9|||||2-Sided|95.0|0.5|1.62|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 19F: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710916|NCT00824850|3148364|Superiority or Other||ratio of geometric mean concentrations|0.63|||||2-Sided|95.0|0.38|1.05|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 18C: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710917|NCT00824850|3148364|Superiority or Other||ratio of geometric mean concentrations|2.24|||||2-Sided|95.0|1.11|4.53|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 14: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710918|NCT00824850|3148364|Superiority or Other||ratio of geometric mean concentrations|1.85|||||2-Sided|95.0|1.25|2.75|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 9V: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710919|NCT00824850|3148364|Superiority or Other||ratio of geometric mean concentrations|2.95|||||2-Sided|95.0|1.78|4.9|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 6B: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710920|NCT00824850|3148364|Superiority or Other||ratio of geometric mean concentrations|1.97|||||2-Sided|95.0|1.31|2.95|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].|7vPnC serotype 4: ratio of GMCs for (7vPnC/13vPnC) relative to (MnCC/13vPnC).|
1710921|NCT00824850|3148365|Superiority or Other||geometric mean fold rise|44.8|||||2-Sided|95.0|21.31|94.01|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710922|NCT00824850|3148365|Superiority or Other||geometric mean fold rise|37.7|||||2-Sided|95.0|10.85|131.09|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710923|NCT00824850|3148365|Superiority or Other||geometric mean fold rise|269.8|||||2-Sided|95.0|105.09|692.6|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711146|NCT00824291|3148512|Superiority or Other||Mean Difference (Net)|2.44||||0.041|2-Sided|95.0|0.1|4.78|||ANCOVA||||
1711147|NCT00824291|3148513|Superiority or Other||Mean Difference (Net)|2.26||||0.035|2-Sided|95.0|0.16|4.37|||ANCOVA||||
1710924|NCT00824850|3148365|Superiority or Other||geometric mean fold rise|60.0|||||2-Sided|95.0|31.06|115.92|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710925|NCT00824850|3148365|Superiority or Other||geometric mean fold rise|8.7|||||2-Sided|95.0|5.21|14.4|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710926|NCT00824850|3148365|Superiority or Other||geometric mean fold rise|75.6|||||2-Sided|95.0|47.32|120.91|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710927|NCT00824850|3148365|Superiority or Other||geometric mean fold rise|91.7|||||2-Sided|95.0|36.25|232.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710928|NCT00824850|3148365|Superiority or Other||geometric mean fold rise|90.5|||||2-Sided|95.0|40.28|203.27|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710929|NCT00824850|3148365|Superiority or Other||geometric mean fold rise|205.5|||||2-Sided|95.0|70.04|602.78|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710930|NCT00824850|3148365|Superiority or Other||geometric mean fold rise|22.2|||||2-Sided|95.0|7.94|61.88|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710931|NCT00824850|3148365|Superiority or Other||geometric mean fold rise|67.8|||||2-Sided|95.0|18.45|249.02|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710932|NCT00824850|3148365|Superiority or Other||geometric mean fold rise|17.8|||||2-Sided|95.0|5.27|59.91|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710933|NCT00824850|3148365|Superiority or Other||geometric mean fold rise|170.2|||||2-Sided|95.0|22.24|1301.79|||||CI for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710934|NCT00824850|3148366|Superiority or Other||geometric mean fold rise|17.7|||||2-Sided|95.0|7.61|41.08|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710935|NCT00824850|3148366|Superiority or Other||geometric mean fold rise|76.4|||||2-Sided|95.0|21.63|270.02|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710936|NCT00824850|3148366|Superiority or Other||geometric mean fold rise|479.6|||||2-Sided|95.0|171.63|1339.96|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710937|NCT00824850|3148366|Superiority or Other||geometric mean fold rise|41.2|||||2-Sided|95.0|23.09|73.48|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710938|NCT00824850|3148366|Superiority or Other||geometric mean fold rise|11.1|||||2-Sided|95.0|6.64|18.52|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710939|NCT00824850|3148366|Superiority or Other||geometric mean fold rise|64.4|||||2-Sided|95.0|37.33|111.18|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710940|NCT00824850|3148366|Superiority or Other||geometric mean fold rise|18.7|||||2-Sided|95.0|6.82|51.39|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710941|NCT00824850|3148366|Superiority or Other||geometric mean fold rise|31.1|||||2-Sided|95.0|12.71|76.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710942|NCT00824850|3148366|Superiority or Other||geometric mean fold rise|102.1|||||2-Sided|95.0|32.0|325.4|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710943|NCT00824850|3148366|Superiority or Other||geometric mean fold rise|23.7|||||2-Sided|95.0|8.67|64.54|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710944|NCT00824850|3148366|Superiority or Other||geometric mean fold rise|151.4|||||2-Sided|95.0|42.01|545.84|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710945|NCT00824850|3148366|Superiority or Other||geometric mean fold rise|7.6|||||2-Sided|95.0|3.47|16.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710946|NCT00824850|3148366|Superiority or Other||geometric mean fold rise|281.7|||||2-Sided|95.0|76.65|1035.49|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710947|NCT00824850|3148367|Superiority or Other||geometric mean fold rise|61.5|||||2-Sided|95.0|28.73|131.76|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710948|NCT00824850|3148367|Superiority or Other||geometric mean fold rise|80.0|||||2-Sided|95.0|23.28|274.82|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710949|NCT00824850|3148367|Superiority or Other||geometric mean fold rise|438.1|||||2-Sided|95.0|169.52|1132.43|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710950|NCT00824850|3148367|Superiority or Other||geometric mean fold rise|78.2|||||2-Sided|95.0|41.38|147.8|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710951|NCT00824850|3148367|Superiority or Other||geometric mean fold rise|8.6|||||2-Sided|95.0|5.36|13.94|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710952|NCT00824850|3148367|Superiority or Other||geometric mean fold rise|66.5|||||2-Sided|95.0|41.8|105.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710953|NCT00824850|3148367|Superiority or Other||geometric mean fold rise|481.0|||||2-Sided|95.0|207.01|1117.69|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710954|NCT00824850|3148367|Superiority or Other||geometric mean fold rise|116.8|||||2-Sided|95.0|54.54|250.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710955|NCT00824850|3148367|Superiority or Other||geometric mean fold rise|226.9|||||2-Sided|95.0|79.81|645.29|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710956|NCT00824850|3148367|Superiority or Other||geometric mean fold rise|26.7|||||2-Sided|95.0|9.67|73.84|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710957|NCT00824850|3148367|Superiority or Other||geometric mean fold rise|61.9|||||2-Sided|95.0|18.83|203.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710958|NCT00824850|3148367|Superiority or Other||geometric mean fold rise|40.3|||||2-Sided|95.0|10.97|148.44|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMRFs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710959|NCT00824850|3148367|Superiority or Other||geometric mean fold rise|168.8|||||2-Sided|95.0|20.22|1409.76|||||CI for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710960|NCT00824850|3148368|Superiority or Other||geometric mean fold rise|24.6|||||2-Sided|95.0|11.3|53.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710961|NCT00824850|3148368|Superiority or Other||geometric mean fold rise|116.9|||||2-Sided|95.0|33.28|410.33|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710962|NCT00824850|3148368|Superiority or Other||geometric mean fold rise|536.5|||||2-Sided|95.0|212.04|1357.19|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710963|NCT00824850|3148368|Superiority or Other||geometric mean fold rise|61.7|||||2-Sided|95.0|32.75|116.34|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710964|NCT00824850|3148368|Superiority or Other||geometric mean fold rise|10.3|||||2-Sided|95.0|6.8|15.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710965|NCT00824850|3148368|Superiority or Other||geometric mean fold rise|78.1|||||2-Sided|95.0|50.42|120.94|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710966|NCT00824850|3148368|Superiority or Other||geometric mean fold rise|32.1|||||2-Sided|95.0|11.99|85.81|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710967|NCT00824850|3148368|Superiority or Other||geometric mean fold rise|48.7|||||2-Sided|95.0|23.27|101.97|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710968|NCT00824850|3148368|Superiority or Other||geometric mean fold rise|93.9|||||2-Sided|95.0|30.99|284.31|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710969|NCT00824850|3148368|Superiority or Other||geometric mean fold rise|37.4|||||2-Sided|95.0|13.71|102.31|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710970|NCT00824850|3148368|Superiority or Other||geometric mean fold rise|156.4|||||2-Sided|95.0|48.72|501.86|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710971|NCT00824850|3148368|Superiority or Other||geometric mean fold rise|11.7|||||2-Sided|95.0|5.2|26.1|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710972|NCT00824850|3148368|Superiority or Other||geometric mean fold rise|201.8|||||2-Sided|95.0|55.11|739.05|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710973|NCT00824850|3148369|Superiority or Other||geometric mean fold rise|1.95|||||2-Sided|95.0|1.59|2.39|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710974|NCT00824850|3148369|Superiority or Other||geometric mean fold rise|2.87|||||2-Sided|95.0|2.19|3.77|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710975|NCT00824850|3148369|Superiority or Other||geometric mean fold rise|2.04|||||2-Sided|95.0|1.51|2.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710976|NCT00824850|3148369|Superiority or Other||geometric mean fold rise|1.3|||||2-Sided|95.0|1.05|1.61|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710977|NCT00824850|3148369|Superiority or Other||geometric mean fold rise|1.32|||||2-Sided|95.0|1.11|1.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710978|NCT00824850|3148369|Superiority or Other||geometric mean fold rise|3.79|||||2-Sided|95.0|2.8|5.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710979|NCT00824850|3148369|Superiority or Other||geometric mean fold rise|2.82|||||2-Sided|95.0|2.08|3.83|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710980|NCT00824850|3148369|Superiority or Other||geometric mean fold rise|2.73|||||2-Sided|95.0|2.08|3.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710981|NCT00824850|3148369|Superiority or Other||geometric mean fold rise|4.92|||||2-Sided|95.0|3.34|7.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710982|NCT00824850|3148369|Superiority or Other||geometric mean fold rise|6.61|||||2-Sided|95.0|4.31|10.15|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710983|NCT00824850|3148369|Superiority or Other||geometric mean fold rise|2.02|||||2-Sided|95.0|1.63|2.49|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710984|NCT00824850|3148369|Superiority or Other||geometric mean fold rise|2.37|||||2-Sided|95.0|1.78|3.16|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710985|NCT00824850|3148369|Superiority or Other||geometric mean fold rise|8.36|||||2-Sided|95.0|4.5|15.56|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710986|NCT00824850|3148370|Superiority or Other||geometric mean fold rise|1.9|||||2-Sided|95.0|1.6|2.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710987|NCT00824850|3148370|Superiority or Other||geometric mean fold rise|3.41|||||2-Sided|95.0|2.42|4.82|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710988|NCT00824850|3148370|Superiority or Other||geometric mean fold rise|3.6|||||2-Sided|95.0|2.39|5.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710989|NCT00824850|3148370|Superiority or Other||geometric mean fold rise|1.67|||||2-Sided|95.0|1.3|2.14|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710990|NCT00824850|3148370|Superiority or Other||geometric mean fold rise|1.63|||||2-Sided|95.0|1.3|2.05|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710991|NCT00824850|3148370|Superiority or Other||geometric mean fold rise|4.23|||||2-Sided|95.0|2.79|6.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710992|NCT00824850|3148370|Superiority or Other||geometric mean fold rise|4.21|||||2-Sided|95.0|2.86|6.19|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710993|NCT00824850|3148370|Superiority or Other||geometric mean fold rise|2.54|||||2-Sided|95.0|1.78|3.62|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710994|NCT00824850|3148370|Superiority or Other||geometric mean fold rise|4.22|||||2-Sided|95.0|2.86|6.23|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710995|NCT00824850|3148370|Superiority or Other||geometric mean fold rise|17.57|||||2-Sided|95.0|11.11|27.79|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710996|NCT00824850|3148370|Superiority or Other||geometric mean fold rise|3.86|||||2-Sided|95.0|2.93|5.09|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710997|NCT00824850|3148370|Superiority or Other||geometric mean fold rise|5.01|||||2-Sided|95.0|3.5|7.16|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710998|NCT00824850|3148370|Superiority or Other||geometric mean fold rise|15.86|||||2-Sided|95.0|9.16|27.46|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1710999|NCT00824850|3148371|Superiority or Other||geometric mean fold rise|3.27|||||2-Sided|95.0|2.49|4.28|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711000|NCT00824850|3148371|Superiority or Other||geometric mean fold rise|5.32|||||2-Sided|95.0|3.65|7.75|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711001|NCT00824850|3148371|Superiority or Other||geometric mean fold rise|4.46|||||2-Sided|95.0|3.09|6.45|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711002|NCT00824850|3148371|Superiority or Other||geometric mean fold rise|1.93|||||2-Sided|95.0|1.43|2.6|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711003|NCT00824850|3148371|Superiority or Other||geometric mean fold rise|1.56|||||2-Sided|95.0|1.3|1.86|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711004|NCT00824850|3148371|Superiority or Other||geometric mean fold rise|7.58|||||2-Sided|95.0|5.36|10.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711005|NCT00824850|3148371|Superiority or Other||geometric mean fold rise|9.0|||||2-Sided|95.0|5.91|13.72|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711006|NCT00824850|3148371|Superiority or Other||geometric mean fold rise|8.98|||||2-Sided|95.0|6.21|12.97|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711007|NCT00824850|3148371|Superiority or Other||geometric mean fold rise|13.68|||||2-Sided|95.0|8.94|20.92|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711008|NCT00824850|3148371|Superiority or Other||geometric mean fold rise|23.46|||||2-Sided|95.0|13.17|41.79|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711009|NCT00824850|3148371|Superiority or Other||geometric mean fold rise|2.78|||||2-Sided|95.0|2.16|3.57|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711010|NCT00824850|3148371|Superiority or Other||geometric mean fold rise|5.7|||||2-Sided|95.0|3.9|8.33|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711011|NCT00824850|3148371|Superiority or Other||geometric mean fold rise|19.68|||||2-Sided|95.0|9.99|38.77|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711012|NCT00824850|3148372|Superiority or Other||geometric mean fold rise|3.02|||||2-Sided|95.0|2.23|4.1|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711013|NCT00824850|3148372|Superiority or Other||geometric mean fold rise|7.2|||||2-Sided|95.0|4.95|10.48|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711014|NCT00824850|3148372|Superiority or Other||geometric mean fold rise|7.7|||||2-Sided|95.0|4.77|12.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711015|NCT00824850|3148372|Superiority or Other||geometric mean fold rise|2.1|||||2-Sided|95.0|1.52|2.9|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711016|NCT00824850|3148372|Superiority or Other||geometric mean fold rise|1.68|||||2-Sided|95.0|1.37|2.07|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711017|NCT00824850|3148372|Superiority or Other||geometric mean fold rise|11.1|||||2-Sided|95.0|6.98|17.64|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711018|NCT00824850|3148372|Superiority or Other||geometric mean fold rise|6.85|||||2-Sided|95.0|4.51|10.42|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711019|NCT00824850|3148372|Superiority or Other||geometric mean fold rise|4.56|||||2-Sided|95.0|2.87|7.26|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711020|NCT00824850|3148372|Superiority or Other||geometric mean fold rise|7.91|||||2-Sided|95.0|4.92|12.73|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711021|NCT00824850|3148372|Superiority or Other||geometric mean fold rise|71.09|||||2-Sided|95.0|40.74|124.08|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711022|NCT00824850|3148372|Superiority or Other||geometric mean fold rise|5.58|||||2-Sided|95.0|4.06|7.67|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711023|NCT00824850|3148372|Superiority or Other||geometric mean fold rise|11.34|||||2-Sided|95.0|8.49|15.13|||||CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711024|NCT00824850|3148372|Superiority or Other||geometric mean fold rise|29.47|||||2-Sided|95.0|17.61|49.33|||||Confidence intervals (CI) for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.|7vPnC serotype 4: Geometric mean fold rises (GMFRs) were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.|
1711025|NCT00824850|3148373|Superiority or Other||difference in proportions|-2.6|||||2-Sided|95.0|-13.9|7.6||||||Additional serotype 19A: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711026|NCT00824850|3148373|Superiority or Other||difference in proportions|3.0|||||2-Sided|95.0|-6.8|15.8||||||Additional serotype 7F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711027|NCT00824850|3148373|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711028|NCT00824850|3148373|Superiority or Other||difference in proportions|1.2|||||2-Sided|95.0|-14.8|18.2||||||Additional serotype 5: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711029|NCT00824850|3148373|Superiority or Other||difference in proportions|-2.6|||||2-Sided|95.0|-13.9|8.0||||||Additional serotype 3: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711030|NCT00824850|3148373|Superiority or Other||difference in proportions|2.9|||||2-Sided|95.0|-7.1|15.0||||||Additional serotype 1: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711031|NCT00824850|3148373|Superiority or Other||difference in proportions|3.0|||||2-Sided|95.0|-9.1|16.6||||||7vPnC serotype 23F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711032|NCT00824850|3148373|Superiority or Other||difference in proportions|-2.8|||||2-Sided|95.0|-16.8|10.1||||||7vPnC serotype 19F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711033|NCT00824850|3148373|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.0|10.1||||||7vPnC serotype 18C: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711034|NCT00824850|3148373|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.3||||||7vPnC serotype 14: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711035|NCT00824850|3148373|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711036|NCT00824850|3148373|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.2|10.6||||||7vPnC serotype 6B: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711037|NCT00824850|3148373|Superiority or Other||difference in proportions|-2.6|||||2-Sided|95.0|-13.9|8.0||||||7vPnC serotype 4: difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.|
1711038|NCT00824850|3148374|Superiority or Other||difference in proportions|-2.6|||||2-Sided|95.0|-13.9|7.6||||||Additional serotype 19A: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711039|NCT00824850|3148374|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.0|10.1||||||Additional serotype 7F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711040|NCT00824850|3148374|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.4|10.3||||||Additional serotype 6A: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711041|NCT00824850|3148374|Superiority or Other||difference in proportions|0.9|||||2-Sided|95.0|-15.0|17.6||||||Additional serotype 5: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711042|NCT00824850|3148374|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 3: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711044|NCT00824850|3148374|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.0|10.1||||||7vPnC serotype 23F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711045|NCT00824850|3148374|Superiority or Other||difference in proportions|-2.6|||||2-Sided|95.0|-13.9|8.0||||||7vPnC serotype 19F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711046|NCT00824850|3148374|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711047|NCT00824850|3148374|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.4|10.3||||||7vPnC serotype 14: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711048|NCT00824850|3148374|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.4|10.3||||||7vPnC serotype 9V: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711049|NCT00824850|3148374|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.0|10.1||||||7vPnC serotype 6B: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711050|NCT00824850|3148374|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-10.2|10.9||||||7vPnC serotype 4: difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided confidence interval.|
1711051|NCT00824850|3148375|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711052|NCT00824850|3148375|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 7F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711053|NCT00824850|3148375|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711054|NCT00824850|3148375|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 5: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711055|NCT00824850|3148375|Superiority or Other||difference in proportions|6.9|||||2-Sided|95.0|-7.4|23.4||||||Additional serotype 3: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711056|NCT00824850|3148375|Superiority or Other||difference in proportions|2.9|||||2-Sided|95.0|-6.9|14.9||||||Additional serotype 1: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711057|NCT00824850|3148375|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||7vPnC serotype 23F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711058|NCT00824850|3148375|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711059|NCT00824850|3148375|Superiority or Other||difference in proportions|3.1|||||2-Sided|95.0|-9.3|17.0||||||7vPnC serotype 18C: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711060|NCT00824850|3148375|Superiority or Other||difference in proportions|5.7|||||2-Sided|95.0|-4.2|19.2||||||7vPnC serotype 14: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711061|NCT00824850|3148375|Superiority or Other||difference in proportions|2.9|||||2-Sided|95.0|-6.9|14.9||||||7vPnC serotype 9V: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711062|NCT00824850|3148375|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||7vPnC serotype 6B: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711063|NCT00824850|3148375|Superiority or Other||difference in proportions|9.0|||||2-Sided|95.0|-5.6|25.5||||||7vPnC serotype 4: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711064|NCT00824850|3148376|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 19A: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711065|NCT00824850|3148376|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 7F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711066|NCT00824850|3148376|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 6A: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711067|NCT00824850|3148376|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 5: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711068|NCT00824850|3148376|Superiority or Other||difference in proportions|-2.2|||||2-Sided|95.0|-15.7|10.9||||||Additional serotype 3: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711069|NCT00824850|3148376|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||Additional serotype 1: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711148|NCT00824291|3148514|Superiority or Other||Mean Difference (Net)|0.23||||0.04|2-Sided|95.0|0.01|0.44|||ANCOVA||||
1711070|NCT00824850|3148376|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||7vPnC serotype 23F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711071|NCT00824850|3148376|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.4|10.3||||||7vPnC serotype 19F: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711072|NCT00824850|3148376|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||7vPnC serotype 18C: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711073|NCT00824850|3148376|Superiority or Other||difference in proportions|2.9|||||2-Sided|95.0|-6.9|14.9||||||7vPnC serotype 14: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711074|NCT00824850|3148376|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||7vPnC serotype 9V: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711075|NCT00824850|3148376|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||7vPnC serotype 6B: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711076|NCT00824850|3148376|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-9.5|10.0||||||7vPnC serotype 4: difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval.|
1711077|NCT00824720|3148388|Superiority or Other||least square mean difference|-1.11|Standard Deviation|3.5||0.4711|||||||ANCOVA||The mean difference was calculated as low dose minus placebo.|The alternative hypothesis is that the low dose was different from placebo.|
1711078|NCT00824720|3148388|Superiority or Other||least square mean difference|-0.22|Standard Deviation|2.3||0.9737|||||||ANCOVA||Mean difference was calculated as high dose minus placebo.|The alternative hypothesis was that the high dose was different from the placebo.|
1711079|NCT00824616|3148397|Superiority or Other||Proportions|5.9||||0.537|2-Sided|95.0|-13.7|25.4|||Miettinen & Nurminen method|||Between-treatment difference (MK-0941 group minus Placebo group) in the percentage of participants who experienced one or more episodes of hypoglycemia.|
1711080|NCT00824616|3148398|Superiority or Other||Mean Difference (Net)|-0.11||||0.745|2-Sided|95.0|-0.81|0.58|||Longitudinal Data Analysis (LDA) model||||
1711081|NCT00824564|3148399|Superiority or Other|||||||0.241|||||||Fisher Exact|||Fisher’s exact test at 5% level of significance was used as the event rate was low and the expected count for any cell in the (unstratified) 2*2 contingency table was less than 5.|
1711082|NCT00824564|3148400|Superiority or Other||Least square means difference|0.11|Standard Error of the Mean|0.276||0.686|2-Sided|95.0|-0.44|0.66|||Mixed Models Analysis|||For change at day 4/ET post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.|
1711083|NCT00824564|3148400|Superiority or Other||Least square means difference|0.2|Standard Error of the Mean|0.249||0.413|2-Sided|95.0|-0.29|0.7|||Mixed Models Analysis|||For change at day 2 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.|
1711084|NCT00824564|3148400|Superiority or Other||Least square means difference|0.14|Standard Error of the Mean|0.244||0.569|2-Sided|95.0|-0.35|0.63|||Mixed Models Analysis|||For change at day 1 post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.|
1711085|NCT00824564|3148400|Superiority or Other||Least square means difference|0.1|Standard Error of the Mean|0.255||0.682|2-Sided|95.0|-0.4|0.61|||Mixed Models Analysis|||For change at 1 hour post-surgery, a MMRM approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.|
1711086|NCT00824564|3148400|Superiority or Other||Least square means difference|0.37|Standard Error of the Mean|0.295||0.208|2-Sided|95.0|-0.21|0.96|||Mixed Models Analysis|||For change at end of surgery, a Mixed Model Repeated Measures (MMRM) approach was used to relate the dependent (outcome) variable and independent (treatment, time point, and treatment-by-time point interaction as factors and baseline value as co-variate) variables taking into account the within-participant correlation arising from the repeated measurements.|
1711087|NCT00824564|3148401|Superiority or Other|||||||0.714|||||||Chi-squared|||Chi-square test was used at 5% level of significance.|
1711088|NCT00824564|3148402|Superiority or Other||Mean Difference (Final Values)|25.2|Standard Error of the Mean|132.1||0.849|2-Sided|95.0|-238.2|288.6|||t-test, 2 sided|||The mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.|
1711089|NCT00824564|3148403|Superiority or Other||Mean Difference (Final Values)|-22.7|Standard Error of the Mean|15.16||0.139|2-Sided|95.0|-52.9|7.5|||t-test, 2 sided|||For 24 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.|
1711090|NCT00824564|3148403|Superiority or Other||Mean Difference (Final Values)|-6.8|Standard Error of the Mean|4.2||0.119|2-Sided|95.0|-15.4|1.8|||t-test, 2 sided|||For 8 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.|
1711149|NCT00824291|3148515|Superiority or Other|||||||0.002|||||||Cochran-Mantel-Haenszel||||
1711091|NCT00824564|3148403|Superiority or Other||Mean Difference (Final Values)|-6.8|Standard Error of the Mean|3.24||0.045|2-Sided|95.0|-13.4|-0.1|||t-test, 2 sided|||For 4 hour post-surgery, the mean difference with associated SE, and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.|
1711092|NCT00824564|3148403|Superiority or Other||Mean Difference (Final Values)|-9.3|Standard Error of the Mean|5.57||0.109|2-Sided|95.0|-20.7|2.2|||t-test, 2 sided|||For 1 hour post-surgery, the mean difference with associated SE and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.|
1711093|NCT00824564|3148404|Superiority or Other||Mean Difference (Final Values)|24.0|Standard Error of the Mean|32.78||0.466|2-Sided|95.0|-41.3|89.3|||t-test, 2 sided|||The mean difference with associated SE and corresponding 95% CI for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.|
1711094|NCT00824564|3148405|Superiority or Other||Mean Difference (Final Values)|-55.5|Standard Error of the Mean|58.63||0.348|2-Sided|95.0|-172.7|61.7|||t-test, 2 sided|||The mean difference with associated standard error (SE), and corresponding 95% confidence interval (CI) for the comparisons of tranexamic acid plus standard of care against Standard of care was presented along with the p-value for the test. Two-sample t-test was performed at 5% level of significance.|
1711095|NCT00824512|3148432|Superiority or Other (legacy)|||||||0.9133||||||No multiplicity adjustment performed for this study and all statistical tests are two-sided at the 5% significance level.|Non parametric ANCOVA on the rank test|The baseline value was used as a covariate.|||
1711096|NCT00824473|3148434|Superiority or Other|||||||0.01|||||||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||change from baseline|
1711097|NCT00824473|3148435|Superiority or Other||Mean Difference (Final Values)|-0.9284|Standard Error of the Mean|0.2741|<|0.001||95.0|-1.47|-0.39|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||reflective TOSS change in baseline|
1711098|NCT00824473|3148436|Superiority or Other||Mean Difference (Final Values)|-1.3947|Standard Error of the Mean|0.3391|<|0.001||95.0|-2.06|-0.73|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Overall change from baseline|
1711099|NCT00824473|3148437|Superiority or Other||Mean Difference (Final Values)|-0.6063|Standard Error of the Mean|0.1697|<|0.001||95.0|-0.94|-0.27|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.|||
1711100|NCT00824473|3148438|Superiority or Other||Mean Difference (Final Values)|-1.4286|Standard Error of the Mean|0.351|<|0.001||95.0|-2.12|-0.74|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Overall change from baseline|
1711101|NCT00824434|3148456|Superiority or Other||Percent Post-procedure Incomplete Apposi|5.7|||<|0.0001|1-Sided|95.0||11.6|||One-sided exact binomial test|||A one-sided 95% Clopper-Pearson upper confidence bound was derived and tested to determine if the outcome was less than a prespecified performance goal based on historical XIENCE V/PROMUS post-procedure incomplete apposition data from the SPIRIT III study (34.4%).|
1711102|NCT00824434|3148457|Superiority or Other||Mean In-stent Late Loss in WH Lesions|0.17|||<|0.0001|1-Sided|95.0||0.22|||t-test, 1 sided|||The Student t-test was used to compare the outcome to a prespecified performance goal of 0.44 mm based on an historical TAXUS Express workhorse 9-month in-stent late loss (0.41 mm) value plus delta (0.03 mm)|
1711103|NCT00824408|3148485|Superiority or Other||Hazard Ratio (HR)|1.081||||0.396|2-Sided|95.0|0.599|1.949|||Log Rank||||
1711104|NCT00824408|3148485|Superiority or Other||Hazard Ratio (HR)|1.073||||0.8406|2-Sided|95.0|0.538|2.14|||Log Rank||||
1711105|NCT00824408|3148486|Superiority or Other|||||||0.2596|||||||Fisher Exact||||
1711106|NCT00824408|3148486|Superiority or Other||||||>|0.9999|||||||Fisher Exact||||
1711107|NCT00824408|3148487|Superiority or Other||Hazard Ratio (HR)|1.141||||0.2804|2-Sided|95.0|0.735|1.771|||Log Rank|||Hazard ratio and 95% CI from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg/m2; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).|
1711108|NCT00824408|3148487|Superiority or Other||Hazard Ratio (HR)|2.045||||0.003|2-Sided|95.0|1.271|3.292|||Log Rank|||Hazard ratio and 95% confidence interval (CI) from Cox proportional-hazards regression model, stratified by histology (Nonsquamous vs. NOS). P-value from log-rank test stratified by histology (one-sided for volasertib 300 mg + pemetrexed 500 mg/m2 vs. pemetrexed 500 mg; two-sided for volasertib 300 mg vs. pemetrexed 500 mg/m2).|
1711109|NCT00824382|3148494|Superiority or Other||Mean Difference (Final Values)|-0.387|Standard Error of the Mean|0.148||0.0095||95.0|-0.678|-0.095|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1711110|NCT00824382|3148494|Superiority or Other||Mean Difference (Final Values)|-0.454|Standard Error of the Mean|0.151||0.0029||95.0|-0.752|-0.156|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1711111|NCT00824382|3148494|Superiority or Other||Mean Difference (Final Values)|-0.191|Standard Error of the Mean|0.149||0.2016||95.0|-0.485|0.103|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1711112|NCT00824382|3148495|Superiority or Other||Mean Difference (Final Values)|37.191|Standard Error of the Mean|5.489|<|0.0001||95.0|26.386|47.996|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1711113|NCT00824382|3148495|Superiority or Other||Mean Difference (Final Values)|30.955|Standard Error of the Mean|5.635|<|0.0001||95.0|19.861|42.049|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1711150|NCT00824291|3148516|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1711151|NCT00824291|3148517|Superiority or Other||Mean Difference (Net)|1.33||||0.067|2-Sided|95.0|-0.09|2.76|||ANCOVA||||
1711114|NCT00824382|3148495|Superiority or Other||Mean Difference (Final Values)|29.052|Standard Error of the Mean|5.534|<|0.0001||95.0|18.159|39.946|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1711115|NCT00824382|3148496|Superiority or Other||Mean Difference (Final Values)|36.678|Standard Error of the Mean|5.431|<|0.0001||95.0|25.987|47.369|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1711116|NCT00824382|3148496|Superiority or Other||Mean Difference (Final Values)|29.383|Standard Error of the Mean|5.574|<|0.0001||95.0|18.41|40.357|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1711117|NCT00824382|3148496|Superiority or Other||Mean Difference (Final Values)|27.256|Standard Error of the Mean|5.476|<|0.0001||95.0|16.477|38.036|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1711118|NCT00824382|3148497|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.038|<|0.0001||95.0|0.115|0.265|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1711119|NCT00824382|3148497|Superiority or Other||Mean Difference (Final Values)|0.176|Standard Error of the Mean|0.039|<|0.0001||95.0|0.1|0.252|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1711120|NCT00824382|3148497|Superiority or Other||Mean Difference (Final Values)|0.082|Standard Error of the Mean|0.039|<|0.0348||95.0|0.006|0.159|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1711121|NCT00824382|3148498|Superiority or Other||Mean Difference (Final Values)|0.217|Standard Error of the Mean|0.038|<|0.0001||95.0|0.142|0.292|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1711122|NCT00824382|3148498|Superiority or Other||Mean Difference (Final Values)|0.216|Standard Error of the Mean|0.039|<|0.0001||95.0|0.14|0.293|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1711123|NCT00824382|3148498|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|0.039|<|0.0045||95.0|0.035|0.188|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1711124|NCT00824382|3148499|Superiority or Other||Least Squares Mean for the difference|0.226|Standard Error of the Mean|0.05|<|0.0001||95.0|0.129|0.324|||ANCOVA|||Olodaterol 10mcg - Placebo|
1711125|NCT00824382|3148499|Superiority or Other||Least Squares Mean for the difference|0.242|Standard Error of the Mean|0.05|<|0.0001||95.0|0.142|0.341|||ANCOVA|||Olodaterol 5mcg - Placebo|
1711126|NCT00824382|3148499|Superiority or Other||Least Squares Mean for the difference|0.253|Standard Error of the Mean|0.05|<|0.0001||95.0|0.155|0.351|||ANCOVA|||Olodaterol 2mcg - Placebo|
1711127|NCT00824382|3148500|Superiority or Other||Least Squares Mean for the difference|0.233|Standard Error of the Mean|0.047|<|0.0001||95.0|0.141|0.325|||ANCOVA|||Olodaterol 10mcg - Placebo|
1711128|NCT00824382|3148500|Superiority or Other||Least Squares Mean for the difference|0.25|Standard Error of the Mean|0.047|<|0.0001||95.0|0.156|0.343|||ANCOVA|||Olodaterol 5mcg - Placebo|
1711129|NCT00824382|3148500|Superiority or Other||Least Squares Mean for the difference|0.253|Standard Error of the Mean|0.047|<|0.0001||95.0|0.16|0.345|||ANCOVA|||Olodaterol 2mcg - Placebo|
1711130|NCT00824382|3148501|Superiority or Other||Least Squares Mean for the difference|0.187|Standard Error of the Mean|0.042|<|0.0001||95.0|0.103|0.27|||ANCOVA|||Olodaterol 10mcg - Placebo|
1711131|NCT00824382|3148501|Superiority or Other||Least Squares Mean for the difference|0.191|Standard Error of the Mean|0.043|<|0.0001||95.0|0.106|0.276|||ANCOVA|||Olodaterol 5mcg - Placebo|
1711132|NCT00824382|3148501|Superiority or Other||Least Squares Mean for the difference|0.191|Standard Error of the Mean|0.043|<|0.0001||95.0|0.107|0.275|||ANCOVA|||Olodaterol 2mcg - Placebo|
1711133|NCT00824382|3148502|Superiority or Other||Least Squares Mean for the difference|0.196|Standard Error of the Mean|0.023|<|0.0001||95.0|0.151|0.24|||ANCOVA|||Olodaterol 10mcg - Placebo|
1711134|NCT00824382|3148502|Superiority or Other||Least Squares Mean for the difference|0.202|Standard Error of the Mean|0.023|<|0.0001||95.0|0.157|0.247|||ANCOVA|||Olodaterol 5mcg - Placebo|
1711135|NCT00824382|3148502|Superiority or Other||Least Squares Mean for the difference|0.146|Standard Error of the Mean|0.023|<|0.0001||95.0|0.101|0.191|||ANCOVA|||Olodaterol 2mcg - Placebo|
1711136|NCT00824382|3148503|Superiority or Other||Least Squares Mean for the difference|0.193|Standard Error of the Mean|0.022|<|0.0001||95.0|0.15|0.236|||ANCOVA|||Olodaterol 10mcg - Placebo|
1711137|NCT00824382|3148503|Superiority or Other||Least Squares Mean for the difference|0.197|Standard Error of the Mean|0.022|<|0.0001||95.0|0.154|0.241|||ANCOVA|||Olodaterol 5mcg - Placebo|
1711138|NCT00824382|3148503|Superiority or Other||Least Squares Mean for the difference|0.138|Standard Error of the Mean|0.022|<|0.0001||95.0|0.095|0.182|||ANCOVA|||Olodaterol 2mcg - Placebo|
1711139|NCT00824382|3148504|Superiority or Other||Mean Difference (Final Values)|0.157|Standard Error of the Mean|0.021|<|0.0001||95.0|0.115|0.199|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1711140|NCT00824382|3148504|Superiority or Other||Mean Difference (Final Values)|0.141|Standard Error of the Mean|0.022|<|0.0001||95.0|0.098|0.184|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1711141|NCT00824382|3148504|Superiority or Other||Mean Difference (Final Values)|0.081|Standard Error of the Mean|0.021|<|0.0002||95.0|0.039|0.124|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1711142|NCT00824382|3148505|Superiority or Other||Least Squares Mean for the difference|0.132|Standard Error of the Mean|0.02|<|0.0001||95.0|0.092|0.172|||ANCOVA|||Olodaterol 10mcg - Placebo|
1711143|NCT00824382|3148505|Superiority or Other||Least Squares Mean for the difference|0.132|Standard Error of the Mean|0.021|<|0.0001||95.0|0.091|0.172|||ANCOVA|||Olodaterol 5mcg - Placebo|
1711144|NCT00824382|3148505|Superiority or Other||Least Squares Mean for the difference|0.091|Standard Error of the Mean|0.02|<|0.0001||95.0|0.051|0.131|||ANCOVA|||Olodaterol 2mcg - Placebo|
1711155|NCT00824265|3148542|Superiority or Other|Participants who took anti-cancer therapies|Hazard Ratio (HR)|0.67||||0.0109|2-Sided|95.0|0.48|0.94|||Log Rank||||
1711156|NCT00824265|3148542|Superiority or Other|Participants in the ITT population|Hazard Ratio (HR)|0.77||||0.1143|2-Sided|95.0|0.55|1.08|||Log Rank||||
1711157|NCT00824265|3148543|Superiority or Other||Hazard Ratio (HR)|0.63||||0.0036|2-Sided|95.0|0.45|0.87|||Log Rank||||
1711158|NCT00824265|3148544|Superiority or Other||Hazard Ratio (HR)|0.77||||0.0878|2-Sided|95.0|0.56|1.05|||Log Rank||||
1711159|NCT00824265|3148545|Superiority or Other||Hazard Ratio (HR)|1.08||||0.449|2-Sided|95.0|0.85|1.37|||Log Rank||||
1711160|NCT00824265|3148546|Superiority or Other||Hazard Ratio (HR)|0.8||||0.1427|2-Sided|95.0|0.59|1.09|||Log Rank||||
1711161|NCT00824265|3148547|Superiority or Other||Hazard Ratio (HR)|0.67||||0.0032|2-Sided|95.0|0.51|0.88|||Log Rank||||
1711162|NCT00824005|3148562|Superiority or Other||Mean Difference (Net)|-0.7|Standard Error of the Mean|8.4||0.7|2-Sided|95.0|-4.78|3.36|||t-test, 2 sided|||Difference in the change between the two groups|
1711163|NCT00824005|3148563|Superiority or Other||Difference in the incidence rates|-0.047|Standard Error of the Mean|0.044||0.47|2-Sided|95.0|-0.133|0.039|||t-test, 2 sided|||The difference in the incidence of major adverse cardiac events between the two groups over time. (Incidence rate)|
1711164|NCT00824005|3148564|Superiority or Other||Mean Difference (Net)|9.5|Standard Deviation|31.2||0.198|2-Sided|95.0|-5.03|23.93|||t-test, 2 sided|||Change in the difference of end diastolic volume between the two groups over time.|
1711165|NCT00824005|3148565|Superiority or Other||Mean Difference (Net)|-34.7|Standard Deviation|176.0||0.55|2-Sided|95.0|-150.0|80.0|||t-test, 2 sided|||Difference in the change in BNP(reg) between cell and placebo group|
1711166|NCT00824005|3148566|Superiority or Other||Mean Difference (Net)|104.0|Standard Deviation|409.0||0.302|2-Sided|95.0|-95.0|303.0|||t-test, 2 sided|||Change in six minute walk distance|
1711167|NCT00824005|3148567|Superiority or Other||Difference in the proportion of particip|0.04|Standard Deviation|0.045||0.28|2-Sided|95.0|-0.01|0.09|||Chi-squared|||Difference in the change in anti-anginal meds across groups|
1711168|NCT00824005|3148568|Superiority or Other||Mean Difference (Net)|-0.176|Standard Error of the Mean|0.845||0.361|2-Sided|95.0|-0.56|0.21|||t-test, 2 sided|||Difference in the change in NYHA score between the two groups|
1711169|NCT00824005|3148569|Superiority or Other||Mean Difference (Net)|-0.25|Standard Deviation|0.784||0.227|2-Sided|95.0|-0.66|0.16|||t-test, 2 sided|||Change in average improvement in Canadian Class Score over time between the two groups.|
1711170|NCT00824005|3148570|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.5||0.471|2-Sided|95.0|-0.3|0.14|||t-test, 2 sided|||Difference in the change between the two groups|
1711171|NCT00824005|3148573|Superiority or Other||Mean Difference (Net)|-1.2|Standard Error of the Mean|22.3||0.835|2-Sided|95.0|-12.5|10.1||Is the change in percent reversible defect the same between the two groups|t-test, 2 sided|||Change in percent of the defect that is reversible|
1711172|NCT00824005|3148574|Superiority or Other||Mean Difference (Net)|1.0|Standard Error of the Mean|23.9||0.856|2-Sided|95.0|-10.05|12.07|||t-test, 2 sided|||Change in the difference of end systolic volume over time.|
1711173|NCT00824005|3148575|Superiority or Other||Mean Difference (Net)|1.0|Standard Error of the Mean|2.9||0.169|2-Sided|95.0|-0.42|2.34||No adjustment for multiple comparisons|t-test, 2 sided|||Compare the change in the cell group to the change in the placebo group.|
1711174|NCT00823901|3148590|Superiority or Other|||||||0.15|||||||t-test, 2 sided||||
1711175|NCT00823836|3148652|Non-Inferiority or Equivalence|Non-inferiority of ropinirole PR/XR tablets to ropinirole IR tablets was assessed with a non-inferiority margin of 2.5.|Median Difference (Net)|0.34||||0.702|2-Sided|95.0|-1.41|2.09||Analysis of covariance (ANCOVA) model: value of change from Week 0 at Week 24 = treatment group + Week 0 value|ANCOVA||||
1711176|NCT00823823|3148654|Superiority or Other|||||||1|||||||Chi-squared|||The frequency of loss of reduction during the study period was compared across casting groups using a two-sided chi-square test with alpha = 0.05.|
1711177|NCT00823719|3148674|Superiority or Other||percentage of participants|61.0|||||2-Sided|95.0|47.4|73.5|||||The estimated value represents the percentage of participants with OR for participants receiving Total Ofatumumab + Chemotherapy treatment.||
1711178|NCT00823719|3148674|Superiority or Other||percentage of participants|55.0|||||2-Sided|95.0|36.4|71.9|||||The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + ICE treatment.||
1711179|NCT00823719|3148674|Superiority or Other||percentage of participants|69.0|||||2-Sided|95.0|48.2|85.7|||||The estimated value represents the percentage of participants with OR for participants receiving Ofatumumab + DHAP treatment.||
1711180|NCT00823303|3148684|Non-Inferiority or Equivalence|On the basis of prior published reports, we estimated a 5% rate of hypercalcemia with paricalcitol and a 30% rate with calcitriol. To have a 90% power to detect a difference at the P=0.05 confidence level, 42 patients per group were needed. Assuming a 30% dropout rate over the course of the study, we planned to randomize 110 patients.||||||0.36|||||||Fisher Exact||||
1711181|NCT00823264|3148685|Superiority or Other|||||||0.049|||||||Wilcoxon (Mann-Whitney)||||
1711182|NCT00823212|3148724|Non-Inferiority or Equivalence|A 2-group Farrington-Manning test was used to test the 1-sided hypothesis of non-inferiority in differences with a non-inferiority margin of 3.5%. A p value <0.05 would indicate non-inferiority and correspond to the upper limit of the 1-sided 95% confidence interval of the difference not exceeding 3.5%.|Difference in percent of participants|0.5||||0.001|1-Sided|95.0||2.13|||Farrington-Manning test||The standard error for the difference was estimated according to the Farrington-Manning test.|Study had 89% statistical power to demonstrate non-inferiority for target lesion failure (TLF, accounting for an expected 1-year attrition rate of 5%), assuming a 1-year TLF rate of 5.5% for both stents.|
1711230|NCT00822523|3148789|Superiority or Other||r value|0.7||||0.188|2-Sided||||||Spearman Correlation Test|||Day 14|
1711231|NCT00822523|3148789|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Day 4|
1711232|NCT00822523|3148790|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Month 4|
1711233|NCT00822523|3148790|Superiority or Other||r value|0.7||||0.188|2-Sided||||||Spearman Correlation Test|||Day 14|
1711183|NCT00823134|3148733|Other|The number of events found per category (PSG and ApneaLink Plus recording) will be compared. Events are Apneas and Hypopneas per hour of sleep, measured as Apnea-Hypopnea-Index (AHI), Apnea-Index (AI), Obstructive AI, Central AI, Hypopnea-Index (HI) and Oxygen Desaturation Index (ODI).|Correlation coefficient (Bland-Altman)|0.75|||||2-Sided|||||||||Per recording, the number of events found per category with PSG and ApneaLink Plus will be compared. As a summary, all PSG values and all ApneaLink Plus values per category will be collected in one graph (Bland-Altmann Plot). The correlation coefficient will be calculated per category. A correlation of >75% will be seen as threshold for validity.|
1711184|NCT00823134|3148734|Other||Mean Difference (Final Values)|2.8|Standard Deviation|4.7||0.021|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1711185|NCT00823082|3148737|Superiority or Other|||||||0.7489|||||||Hodges-Lehmann test||||
1711186|NCT00823082|3148738|Superiority or Other|||||||0.9574|||||||Hodges-Lehmann||||
1711187|NCT00823082|3148739|Superiority or Other|||||||0.6218|||||||Fisher Exact|||ICU discharge visit|
1711188|NCT00823082|3148739|Superiority or Other|||||||1|||||||Fisher Exact|||Follow-up visit|
1711189|NCT00823082|3148740|Superiority or Other|||||||0.4936|||||||Fisher Exact||||
1711190|NCT00823082|3148741|Superiority or Other|||||||0.446|||||||Fisher Exact||||
1711191|NCT00823082|3148742|Superiority or Other|||||||0.2705|||||||ANCOVA|||Units of platelets|
1711192|NCT00823082|3148742|Superiority or Other|||||||0.7453|||||||ANCOVA|||Units of fresh frozen plasma|
1711193|NCT00823082|3148742|Superiority or Other|||||||0.7433|||||||ANCOVA|||Number of units of packed red blood cells|
1711194|NCT00823082|3148743|Superiority or Other|||||||0.0209|||||||ANCOVA||||
1711195|NCT00823082|3148744|Superiority or Other|||||||0.0004|||||||Fisher Exact||||
1711196|NCT00823082|3148745|Superiority or Other|||||||1|||||||Fisher Exact||||
1711197|NCT00823082|3148746|Superiority or Other|||||||0.3897|||||||Hodges-Lehmann test||||
1711198|NCT00823082|3148747|Superiority or Other|||||||0.487|||||||Fisher Exact|||ICU discharge visit|
1711199|NCT00823082|3148748|Superiority or Other|||||||1|||||||Fisher Exact|||ICU discharge visit|
1711200|NCT00823082|3148748|Superiority or Other|||||||0.1211|||||||Fisher Exact|||Follow-up visit|
1711201|NCT00823082|3148749|Superiority or Other|||||||0.6115|||||||Fisher Exact|||At ICU discharge visit|
1711202|NCT00823082|3148750|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1711203|NCT00823082|3148751|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1711204|NCT00823043|3148754|Superiority or Other|||||||0.69|||||||t-test, 2 sided||||
1711205|NCT00823043|3148755|Superiority or Other|||||||0.75|||||||t-test, 2 sided||||
1711206|NCT00823043|3148756|Superiority or Other|||||||0.024|||||||t-test, 2 sided||||
1711207|NCT00823043|3148757|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1711208|NCT00822900|3148769|Superiority or Other||Risk Ratio (RR)|3.03|||||2-Sided|95.0|1.96|4.66|||||A risk ratio (equivalent to the relative risk) of more than 1.00 indicating more events in the progesterone group than in the placebo group.||
1711209|NCT00822900|3148771|Superiority or Other||Hazard Ratio (HR)|1.19|||||2-Sided|95.0|0.86|1.63|||||A hazard ratio of more than 1.00 indicating higher hazard of death from the progesterone group than in the placebo group.|The Cox proportional hazards model is used to compare these curves after adjustment for age, sex and injury severity.|
1711210|NCT00822900|3148772|Superiority or Other||Risk Ratio (RR)|0.95||||0.35|2-Sided|95.0|0.85|1.06|||Regression, Generalized linear|Adjusting for injury severity, sex, and age. the binomial distribution with the log link is used to estimate treatment effect as relative risk.|A risk ratio (equivalent to the relative risk) of less than 1.00 indicating fewer favorable outcomes in the progesterone group than in the placebo group.|Test of null hypothesis (equal proportions of subjects with favorable outcome in progesterone and placebo arms) versus alternative hypothesis (unequal proportions of subjects with favorable outcome in progesterone and placebo arms). Standard multiple imputation methods are used to account for missing data. The primary outcome measure is based on the stratified dichotomy approach.|
1711211|NCT00822523|3148783|Superiority or Other||r value|0.4||||0.505|2-Sided||||||Spearman Correlation Test|||Month 4|
1711212|NCT00822523|3148783|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Day 14|
1711213|NCT00822523|3148783|Superiority or Other||r value|0.99|||<|0.0001|2-Sided||||||Spearman Correlation Test|||Day 4|
1711214|NCT00822523|3148784|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Month 4|
1711215|NCT00822523|3148784|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Day 14|
1711216|NCT00822523|3148784|Superiority or Other||r value|0.99|||<|0.0001|2-Sided||||||Spearman Correlation Test|||Day 4|
1711217|NCT00822523|3148785|Superiority or Other||r value|0.5||||0.391|2-Sided||||||Spearman Correlation Test|||Month 4|
1711218|NCT00822523|3148785|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Day 14|
1711219|NCT00822523|3148785|Superiority or Other||r value|0.99|||<|0.0001|2-Sided||||||Spearman Correlation Test|||Day 4|
1711220|NCT00822523|3148786|Superiority or Other||r value|0.7||||0.188|2-Sided||||||Spearman Correlation Test|||Month 4|
1711221|NCT00822523|3148786|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Day 14|
1711222|NCT00822523|3148786|Superiority or Other||r value|0.99|||<|0.0001|2-Sided||||||Spearman Correlation Test|||Day 4|
1711223|NCT00822523|3148787|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Month 4|
1711224|NCT00822523|3148787|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Day 14|
1711225|NCT00822523|3148787|Superiority or Other||r value|0.99|||<|0.0001|2-Sided||||||Spearman Correlation Test|||Day 4|
1711226|NCT00822523|3148788|Superiority or Other||r value|0.8||||0.104|2-Sided||||||Spearman Correlation Test|||Month 4|
1711227|NCT00822523|3148788|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Day 14|
1711228|NCT00822523|3148788|Superiority or Other||r value|0.99|||<|0.0001|2-Sided||||||Spearman Correlation Test|||Day 4|
1714098|NCT00786864|3154190|Superiority or Other||||||p<|0|||||||ANCOVA||||
1711234|NCT00822523|3148790|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Day 4|
1711235|NCT00822523|3148791|Superiority or Other||r value|0.5||||0.391|2-Sided||||||Spearman Correlation Test|||Month 4|
1711236|NCT00822523|3148791|Superiority or Other||r value|0.7||||0.188|2-Sided||||||Spearman Correlation Test|||Day 14|
1711237|NCT00822523|3148791|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Day 4|
1711238|NCT00822523|3148792|Superiority or Other||r value|0.7||||0.188|2-Sided||||||Spearman Correlation Test|||Month 4|
1711239|NCT00822523|3148792|Superiority or Other||r value|0.7||||0.188|2-Sided||||||Spearman Correlation Test|||Day 14|
1711240|NCT00822523|3148792|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Day 4|
1711241|NCT00822523|3148793|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Month 4|
1711242|NCT00822523|3148793|Superiority or Other||r value|0.7||||0.188|2-Sided||||||Spearman Correlation Test|||Day 14|
1711243|NCT00822523|3148793|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Day 4|
1711244|NCT00822523|3148795|Superiority or Other||r value|0.8||||0.104|2-Sided||||||Spearman Correlation Test|||Month 4|
1711245|NCT00822523|3148795|Superiority or Other||r value|0.7||||0.188|2-Sided||||||Spearman Correlation Test|||Day 14|
1711246|NCT00822523|3148795|Superiority or Other||r value|0.9||||0.0374|2-Sided||||||Spearman Correlation Test|||Day 4|
1711247|NCT00822523|3148797|Superiority or Other|||||||0.2088|||||||Repeated measure ANOVA|||"Repeated measure ANOVA assessing percent change in force from baseline for day 14 and 21 by treatment arm.~H0: There is no significant different in percent change in force by treatment arm HA: There is a significant different in percent change in force by treatment arm"|
1711248|NCT00822523|3148797|Superiority or Other|||||||0.995|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing percent change (from baseline) in force for contrast of day 14 and day 21 H0: There is no difference in percent change in force between day 14 and day 21 HA: There is a difference in percent change in force between day 14 and day 21|
1711249|NCT00822523|3148798|Superiority or Other|||||||0.178|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing change in baseline force by treatment arm. H0: There is no difference in mean baseline force by treatment arm HA: There is a difference in mean baseline force by treatment arm|
1711250|NCT00822523|3148798|Superiority or Other|||||||0.636|||||||Repeated measure ANOVA|||Repeated measure ANOVA assessing change in the three baseline force measurements H0: There no significant difference in the three baseline force measurements HA: There is a significant difference in the three baseline force measurements|
1711251|NCT00822523|3148799|Superiority or Other|||||||0.589|||||||t-test, 2 sided|||Two sample t-test comparing baseline and month 4 H0: There is no change in mean force between baseline and month 4 HA: There is change in mean force between baseline and month 4|
1711252|NCT00822523|3148799|Superiority or Other|||||||0.292|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 21 H0: There is no change in mean force between baseline and day 21 HA: There is change in mean force between baseline and day 21|
1711253|NCT00822523|3148799|Superiority or Other|||||||0.256|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 14 H0: There is no change in mean force between baseline and day 14 HA: There is change in mean force between baseline and day 14|
1711254|NCT00822523|3148799|Superiority or Other|||||||0.234|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 4 H0: There is no change in mean force between baseline and day 4 HA: There is change in mean force between baseline and day 4|
1711255|NCT00822523|3148799|Superiority or Other|||||||0.787|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 2 H0: There is no change in mean force between baseline and day 2 HA: There is change in mean force between baseline and day 2|
1711256|NCT00822523|3148799|Superiority or Other|||||||0.61|||||||t-test, 2 sided|||Two sample t-test comparing baseline and day 1 H0: There is no change in mean force between baseline and day 1 HA: There is change in mean force between baseline and day 1|
1711257|NCT00822510|3148800|Superiority or Other|||||||0.01|||||||ANOVA||||
1711258|NCT00822510|3148801|Superiority or Other|||||||0.71|||||||ANOVA||||
1711259|NCT00822510|3148802|Superiority or Other|||||||0.001|||||||ANOVA||||
1711260|NCT00822510|3148803|Superiority or Other|||||||0.001|||||||ANOVA||||
1711261|NCT00822510|3148804|Superiority or Other|||||||0.79|||||||ANOVA||||
1711262|NCT00822510|3148806|Superiority or Other||||||<|0.05|||||||ANOVA||||
1711263|NCT00822328|3148813|Superiority or Other||||||<|0.05|||||||ANOVA|||Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).|
1711264|NCT00822328|3148815|Superiority or Other||||||<|0.05|||||||ANOVA|||Bacterial colonies were counted for study group and placebo group on week 0, 1, 2, 3, 4, 5, 6. Significant differences between both experimental groups at the same time were determined with one-way ANOVA (significance level p = 0.05).|
1711265|NCT00822172|3148835|Superiority|||||||0.65|||||||two-sample equal-variances t-test||||
1711266|NCT00822172|3148836|Superiority|||||||0.048|||||||two-sample equal-variances t-test||||
1711267|NCT00822172|3148837|Superiority|||||||0.076|||||||two-sample equal-variances t-test||||
1711268|NCT00821678|3148875|Superiority or Other||Odds Ratio (OR)|7.9|||<|0.001|2-Sided|95.0|3.2|19.6|||Mixed Models Analysis||||
1711269|NCT00821678|3148876|Superiority or Other||Odds Ratio, log|0.86||||0.65|2-Sided|95.0|0.46|1.62|||Mixed Models Analysis||||
1711270|NCT00821678|3148879|Superiority or Other||Slope|2.67||||0.02|2-Sided|95.0|0.45|4.91|||Mixed Models Analysis||||
1711271|NCT00821678|3148880|Superiority or Other||Mean Difference (Final Values)|0.18||||0.48|2-Sided|95.0|-0.33|0.7|||t-test, 2 sided||||
1711272|NCT00821678|3148881|Superiority or Other||Slope|-0.25||||0.001|2-Sided|95.0|-0.4|-0.1|||Mixed Models Analysis||||
1711273|NCT00821678|3148882|Superiority or Other||Slope|-3.81||||0.002|2-Sided|95.0|-6.19|-1.43|||Mixed Models Analysis||||
1711416|NCT00818662|3149268|Superiority or Other||Difference in least-square means|0.0||||0.988||95.0|-1.5|1.5|||ANCOVA||||
1711274|NCT00821587|3148886|Superiority or Other||||||<|0.05||||||We hypothesize that subjects on CsA are more likely to achieve undetectable viral level in patients receiving antiviral therapy for recurrent HCV after Liver Transplant|Chi-squared|||We hypothesize that subjects on CsA are more likely to achieve undetectable viral levels after liver transplant. Comparisons between the two groups (Undetectable viral level vs. Detectable viral level) were performed with Pearson Chi-square tests or Fisher’s exact test for categorical variables, and Mann–Whitney U test for continuous variables.|
1711275|NCT00821509|3148887|Superiority or Other||ratio of proportions|0.933||||0.04|||||||proportion test|||According to the null hypothesis the proportion of weeks with an onset of an infectious disease period in neither of the intervention arms was different from that of control. No in advance power calculations were done.|
1711276|NCT00821509|3148888|Superiority or Other||ratio of proportions|1.03||||0.004|||||||proportion test|The test was carried out using the proportions calculated from the number of sick-leave episodes over the number o total follow-up weeks in each arm||According to the null hypothesis the proportion of weeks with an onset of days-off period in neither of the intervention arms was different from that of control. No in advance power calculations were done.|
1711277|NCT00821119|3148899|Superiority or Other||Risk Ratio (RR)|1.06|Standard Error of the Mean|0.18|<|0.05|2-Sided|95.0|0.62|1.78|||risk ratio (RR)|||The study was not powered for this outcome. However this analysis was done with this limitation|
1711278|NCT00821119|3148900|Superiority or Other||Risk Ratio (RR)|0.7|Standard Error of the Mean|0.16||0.05|2-Sided|95.0|0.48|1.14|||risk ratio (RR)|||Based on previous data from our NICU, 40 - 45% of our preterm infants administered early NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.|
1711279|NCT00821119|3148901|Superiority or Other||Risk Ratio (RR)|0.7|Standard Error of the Mean|0.16|<|0.05|2-Sided|95.0|0.48|1.14|||risk ratio (RR)|||"Based on previous data from our NICU, 40 - 45% of our preterm infants administered early NCPAP for RDS needed intubation and mechanical ventilation within the first 72h of life. We estimated a 20% absolute reduction in the need of using ETT ventilation with the early use of NIPPV. A sample size of 100 infants per group was calculated with a power of 80% and an alpha error of 5%.~The analysis was performed according to the intention-to-treat principle."|
1711280|NCT00820755|3148923|Superiority or Other||Hazard Ratio (HR)|0.774||||0.0622||95.0|0.613|0.976|||Log Rank|||Exploratory analysis to test the null hypothesis of no difference between maintenance therapy regimen. Model is adjusted by histology (IVRS) and tumor response status at the end of combination therapy (‘CR or PR’ versus ‘other’).|
1711281|NCT00820755|3148925|Superiority or Other||Hazard Ratio, log|0.959||||0.1265|2-Sided|95.0|0.736|1.25|||Log Rank|||Exploratory analysis to test the null hypothesis of no difference between maintenance therapy regimen. Model is adjusted by histology (interactive voice response system [IVRS]) and tumor response status at the end of combination therapy (‘complete response [CR] or partial response [PR]’ versus ‘other’).|
1711282|NCT00820664|3148928|Superiority or Other||Least Squares Mean|0.19||||0.032||95.0|0.02|1.0||1-sided, alpha=0.05|ANOVA|A one-way ANOVA model with term treatment was fit to the square root transformed response.|||
1711283|NCT00820664|3148928|Superiority or Other||Least Squares Mean|0.49|||<|0.001||95.0|0.31|1.0||1-sided, alpha=0.05|ANOVA|A one-way ANOVA model with term treatment was fit to the square root transformed response.|||
1711284|NCT00820573|3148930|Superiority or Other|||||||0.05|||||||ANOVA||||
1711285|NCT00820573|3148931|Superiority or Other|||||||0.05|||||||ANOVA|||ANOVA|
1711286|NCT00820573|3148932|Superiority or Other||||||<|0.05|||||||ANOVA|||multivariate analysis was performed to compare results amongst all four groups|
1711287|NCT00820573|3148933|Superiority or Other||||||<|0.05|||||||ANOVA|||"A general unstructured variance-covariance matrix (ANOVA) was applied for measurements at different periods. Between-group comparisons after 6 wks of treatment were assessed using the ANOVA model at alpha=0.05 (two-sided).~16 subjects provide ~90% power to detect difference in EGP of 0.28 mg/kg.min (95% CI = 0.17 mg/kg.min)."|
1711288|NCT00820248|3148941|Superiority||Cox Proportional Hazard|0.89||||0.66|2-Sided|95.0|0.54|1.48|||Log Rank||hazard ratio for panitumumab vs cisplatin||
1711289|NCT00820248|3148942|Superiority||Hazard Ratio (HR)|0.95||||0.83|2-Sided|95.0|0.6|1.5|||Regression, Cox||Hazard ratio of panitumumab vs cisplatin|The log rank test stratified by the stratification factors at randomization was used to compare the difference in PFS between two treatment arms.|
1711290|NCT00820222|3148952|Superiority||Odds Ratio (OR)|0.9016||||0.6106|2-Sided|95.0|0.6315|1.2866|||Fisher Exact|||Comparison for Clinical Benefit|
1711291|NCT00820222|3148953|Superiority||Odds Ratio (OR)|0.7984||||0.2731|2-Sided|95.0|0.5407|1.1771|||Fisher Exact|||Comparison for Overall Response (CR+PR)|
1711292|NCT00820222|3148954|Superiority||Hazard Ratio (HR)|1.34||||0.095|2-Sided|95.0|0.95|1.9|||Log Rank||A HR > 1 indicates a higher risk for lapatinib+capecitabine compared with trastuzumab+capecitabine.||
1711293|NCT00820222|3148956|Superiority||Hazard Ratio (HR)|1.3||||0.021|2-Sided|95.0|1.04|1.64|||Log Rank||A HR > 1 indicates a higher risk for lapatinib+capecitabine compared with trastuzumab+capecitabine.||
1711294|NCT00820222|3148957|Superiority or Other||Odds Ratio (OR)|0.65||||0.36|2-Sided|95.0|0.26|1.63|||Odds Ratio||The Odds Ratio is based on a logistic regression model. The P-value for the test of Odds Ratio is 1.||
1711295|NCT00820027|3148968|Other|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.04|||||2-Sided|95.0|0.89|1.23|||||A ratio <1 indicates a beneficial effect of Etoricoxib.||
1711296|NCT00820027|3148968|Other|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.01|||||2-Sided|95.0|0.85|1.18|||||A ratio <1 indicates a beneficial effect of Etoricoxib.||
1711297|NCT00820027|3148968|Other|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|Between-Treatment Ratio|1.05|||||2-Sided|95.0|0.89|1.23|||||A ratio <1 indicates a beneficial effect of Etoricoxib.||
1711417|NCT00818662|3149269|Superiority or Other||Difference in least-square means|-1.3||||0.41||95.0|-4.5|1.9|||ANCOVA||||
1711298|NCT00820027|3148969|Non-Inferiority|Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.|Mean Difference (Final Values)|-0.1|||||2-Sided|95.0|-0.42|0.22|||||||
1711299|NCT00820027|3148969|Non-Inferiority|Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.|Difference in Least Squares Mean|-0.04|||||2-Sided|95.0|-0.36|0.27|||||||
1711300|NCT00820027|3148970|Other||Difference in Percent|1.8||||0.684|2-Sided|95.0|-7.0|10.6|||Miettinen & Nurminen||||
1711301|NCT00820027|3148970|Other||Difference in Percent|5.5||||0.349|2-Sided|95.0|-5.9|17.2|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg|
1711302|NCT00820027|3148970|Other||Difference in Percent|-1.6||||0.718|2-Sided|95.0|-10.5|7.3|||Miettinen & Nurminen||||
1711303|NCT00820027|3148970|Other||Difference in Percent|0.2||||0.965|2-Sided|95.0|-8.7|9.0|||Miettinen & Nurminen||||
1711304|NCT00820027|3148970|Other||Difference in Percent|-5.5||||0.349|2-Sided|95.0|-17.2|5.9|||Miettinen & Nurminen||||
1711305|NCT00820027|3148970|Other||Difference in Percent|-7.2||||0.222||95.0|-18.8|4.2|||Miettinen & Nurminen||||
1711306|NCT00820027|3148970|Other||Difference in Percent|-5.3||||0.365|2-Sided|95.0|-17.0|6.0|||Miettinen & Nurminen||||
1711307|NCT00820027|3148971|Other||Difference in Percent|-2.3||||0.113|2-Sided|95.0|-5.8|0.6|||Miettinen & Nurminen||||
1711308|NCT00820027|3148971|Other||Difference in Percent|-0.1||||0.971|2-Sided|95.0|-3.9|5.7|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg|
1711309|NCT00820027|3148971|Other||Difference in Percent|-1.8||||0.184|2-Sided|95.0|-5.2|1.0|||Miettinen & Nurminen||||
1711310|NCT00820027|3148971|Other||Difference in Percent|0.5||||0.786|2-Sided|95.0|-3.2|4.2|||Miettinen & Nurminen||||
1711311|NCT00820027|3148971|Other||Difference in Percent|0.1||||0.971|2-Sided|95.0|-5.7|3.9|||Miettinen & Nurminen||||
1711312|NCT00820027|3148971|Other||Difference in Percent|-1.8||||0.278|2-Sided|95.0|-7.4|1.4|||Miettinen & Nurminen||||
1711313|NCT00820027|3148971|Other||Difference in Percent|0.5||||0.806|2-Sided|95.0|-5.3|4.5|||Miettinen & Nurminen||||
1711314|NCT00820027|3148972|Other||Difference in Percent|0.8||||0.437|2-Sided|95.0|-1.7|3.6|||Miettinen & Nurminen||||
1711315|NCT00820027|3148972|Other||Difference in Percent|2.3||||0.227|2-Sided|95.0|-1.3|8.4|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg|
1711316|NCT00820027|3148972|Other||Difference in Percent|-0.1||||0.965|2-Sided|95.0|-3.0|2.8|||Miettinen & Nurminen||||
1711317|NCT00820027|3148972|Other||Difference in Percent|-0.9||||0.415|2-Sided|95.0|-3.7|1.6|||Miettinen & Nurminen||||
1711318|NCT00820027|3148972|Other||Difference in Percent|-2.3||||0.227|2-Sided|95.0|-8.4|1.3|||Miettinen & Nurminen||||
1711319|NCT00820027|3148972|Other||Difference in Percent|-2.3||||0.209|2-Sided|95.0|-8.4|1.2|||Miettinen & Nurminen||||
1711320|NCT00820027|3148972|Other||Difference in Percent|-3.2||||0.054|2-Sided|95.0|-9.2|0.1|||Miettinen & Nurminen||||
1711321|NCT00820027|3148973|Other||Difference in Percent|-0.5||||0.309|2-Sided|95.0|-2.5|1.2|||Miettinen & Nurminen||||
1711322|NCT00820027|3148973|Other||Difference in Percent|0.0|||>|0.999|2-Sided|95.0|-1.7|3.8|||Miettinen & Nurminen|||Placebo vs. Ibuprofen 1800 mg|
1711323|NCT00820027|3148973|Superiority||Difference in Percent|0.0|||>|0.999|2-Sided|95.0|-1.7|1.7|||Miettinen & Nurminen||||
1711324|NCT00820027|3148973|Other||Difference in Percent|0.5|||>|0.316|2-Sided|95.0|-1.3|2.5|||Miettinen & Nurminen||||
1711325|NCT00820027|3148973|Other||Difference in Percent|0.0|||>|0.999|2-Sided|95.0|-3.8|1.7|||Miettinen & Nurminen||||
1711326|NCT00820027|3148973|Other||Difference in Percent|0.0|||>|0.999|2-Sided|95.0|-3.8|1.7|||Miettinen & Nurminen||||
1711327|NCT00820027|3148973|Other||Difference in Percent|0.5|||>|0.506|2-Sided|95.0|-3.3|2.5|||Miettinen & Nurminen||||
1711328|NCT00820027|3148974|Superiority||Between-Treatment Ratio|0.66|||<|0.001|2-Sided|95.0|0.54|0.82|||ANOVA|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|A ratio <1 indicates a beneficial effect of Etoricoxib.||
1711329|NCT00820027|3148974|Superiority||Between-Treatment Ratio|0.69|||<|0.001|2-Sided|95.0|0.56|0.85|||ANOVA|Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|A ratio <1 indicates a beneficial effect of Etoricoxib.||
1711330|NCT00820027|3148975|Superiority||Difference in Least Squares Mean|-0.54||||0.009|2-Sided|95.0|-0.95|-0.14|||LDA|Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|||
1711331|NCT00820027|3148975|Superiority||Difference in Least Squares Mean|-0.49||||0.018|2-Sided|95.0|-0.89|-0.08|||longitudinal data analysis (LDA)|Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.|||
1711332|NCT00819780|3148986|Superiority or Other||Odds Ratio (OR)|1.05||||1|2-Sided|95.0|0.52|2.15|||Stratified exact test|Stratified by prior exposure to oxaliplatin|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.||
1711333|NCT00819780|3148987|Superiority or Other||Odds Ratio (OR)|1.08||||0.9426|2-Sided|95.0|0.55|2.12|||Stratified exact test|Stratified by prior exposure to oxaliplatin|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.||
1711334|NCT00819780|3148988|Superiority or Other||Cox Proportional Hazard|0.465||||0.0235|2-Sided|95.0|0.239|0.902|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio < 1.0 favors panitumumab||
1711335|NCT00819780|3148989|Superiority or Other||Cox Proportional Hazard|0.606||||0.0934|2-Sided|95.0|0.337|1.088|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant Oxaliplatin therapy|A hazard ratio < 1.0 favors panitumumab||
1711418|NCT00818662|3149269|Superiority or Other||Difference in least-square means|-0.6||||0.695||95.0|-3.6|2.4|||ANCOVA||||
1711336|NCT00819780|3148990|Superiority or Other||Cox Proportional Hazard|0.579||||0.0083|2-Sided|95.0|0.386|0.869|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio < 1.0 favors panitumumab||
1711337|NCT00819780|3148991|Superiority or Other||Cox Proportional Hazard|0.651||||0.0286|2-Sided|95.0|0.444|0.956|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio < 1.0 favors panitumumab||
1711338|NCT00819780|3148994|Superiority or Other||Cox Proportional Hazard|0.874||||0.3861|2-Sided|95.0|0.645|1.185|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio < 1.0 favors panitumumab||
1711339|NCT00819780|3148996|Superiority or Other||Odds Ratio (OR)|1.19||||0.5497|2-Sided|95.0|0.72|1.95|||Stratified exact test|Stratified by prior adjuvant oxaliplatin therapy|The odds ratio is defined as the odds of having an objective response in the panitumumab plus mFOLFOX6 arm relative to the odds in the bevacizumab plus mFOLFOX6 arm.||
1711340|NCT00819780|3148997|Superiority or Other||Cox Proportional Hazard|0.723||||0.1386|2-Sided|95.0|0.47|1.111|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio < 1.0 favors panitumumab||
1711341|NCT00819780|3148998|Superiority or Other||Cox Proportional Hazard|0.871||||0.3531|2-Sided|95.0|0.651|1.166|||Stratified Cox proportional hazards|The Cox proportional hazard model is stratified by prior adjuvant oxaliplatin therapy|A hazard ratio < 1.0 favors panitumumab||
1711342|NCT00819741|3149016|Non-Inferiority or Equivalence|"If non-inferiority was shown (that was if H0 was rejected), then superiority of repaglinide and metformin combination therapy compared to repaglinide monotherapy would be claimed if the upper limit of the 95% CI for the difference was lower than 0%.~The non-inferiority margin for HbA1c was set to 0.4%."|Estimated treatment difference, LS Mean|-0.302|Standard Error of the Mean|0.0096||||95.0|-0.491|-0.114||||||"The non-inferiority margin for HbA1c was set to 0.4%.~The null hypothesis (H0) was:~H0: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment – HbA1c of repaglinide monotherapy after 16 weeks of treatment ≥0.4%~Against the alternative hypothesis (H1):~H1: HbA1c of repaglinide + metformin therapy after 16 weeks of treatment – HbA1c of repaglinide monotherapy after 16 weeks of treatment <0.4%"|
1711343|NCT00819507|3149041|Superiority||Median Difference (Final Values)|14.35|||<|0.01|2-Sided||||||t-test, 2 sided||||
1711344|NCT00819507|3149042|Superiority||Mean Difference (Final Values)|6.01|||<|0.01|2-Sided||||||t-test, 2 sided||||
1711345|NCT00819390|3149073|Superiority or Other|||||||0.247||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Wilcoxon (Mann-Whitney)|No other adjustments.||Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.|
1711346|NCT00819390|3149073|Superiority or Other|||||||0.428||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance used for the two-sided test was 0.05.|Wilcoxon (Mann-Whitney)|No other adjustments||Null hypothesis: There is no difference between the two arms/groups with respect to change in percent CD8 HLA-DR+/CD38+ from baseline to week 12.|
1711347|NCT00819286|3149074|Superiority or Other||Mean Difference (Final Values)|0.0||||0.93||95.0|||||t-test, 1 sided|||Plates vs Wires|
1711348|NCT00819286|3149075|Superiority or Other|||||||0.01|||||||t-test, 2 sided|||6 Month CT Scores (Plates vs Wires)|
1711349|NCT00819286|3149075|Superiority or Other||Mean Difference (Final Values)|0.0||||0.003|2-Sided|95.0|||||t-test, 2 sided|||3 Month CT Scores (Plates vs Wires)|
1711350|NCT00819234|3149106|Superiority or Other||LS Mean|-5.52|Standard Error of the Mean|2.887||0.0595|2-Sided|95.0|-11.27|0.23|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons|
1711351|NCT00819234|3149106|Superiority or Other||LS Mean|-6.55|Standard Error of the Mean|2.681||0.0168|2-Sided|95.0|-11.89|-1.21|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons|
1711352|NCT00819234|3149106|Superiority or Other||LS Mean Difference|-7.23|Standard Error of the Mean|2.863||0.0135|2-Sided|95.0|-12.93|-1.54|||t-test, 2 sided|||Treatment comparisons between each active treatment and placebo. Statistical tests performed two-sided at a significance level of α = 0.05. The null hypothesis tested was that there is no difference between each active treatment and the placebo treatment. The primary analysis did not incorporate any adjustment for multiple comparisons.|
1711353|NCT00819156|3149124|Superiority or Other|||||||0.429|||||||Log Rank||||
1711354|NCT00819156|3149125|Superiority or Other|||||||0.165|||||||Log Rank||||
1711355|NCT00819156|3149126|Superiority or Other|||||||0.0933|||||||Log Rank||||
1711356|NCT00819156|3149127|Superiority or Other||Percentage|93.0||||||95.0|78.0|99.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.||
1711357|NCT00819156|3149127|Superiority or Other||Percentage|91.0||||||95.0|76.0|98.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.||
1711358|NCT00819156|3149127|Superiority or Other||Percentage|93.0||||||95.0|78.0|99.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.||
1711359|NCT00819156|3149127|Superiority or Other||Percentage|87.0||||||95.0|70.0|96.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.||
1711360|NCT00819156|3149127|Superiority or Other||Percentage|94.0||||||95.0|79.0|99.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.||
1714099|NCT00786864|3154191|Superiority or Other||||||p<|0|||||||ANCOVA||||
1711361|NCT00819156|3149127|Superiority or Other||Percentage|83.0||||||95.0|65.0|94.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 3. The 95% Confidence Interval was calculated with the Clopper-Pearson method.||
1711362|NCT00819156|3149128|Superiority or Other||Percentage|93.0||||||95.0|77.0|99.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.||
1711363|NCT00819156|3149128|Superiority or Other||Percentage|94.0||||||95.0|80.0|99.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.||
1711364|NCT00819156|3149128|Superiority or Other||Percentage|97.0||||||95.0|83.0|100.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.||
1711365|NCT00819156|3149128|Superiority or Other||Percentage|97.0||||||95.0|84.0|100.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.||
1711366|NCT00819156|3149128|Superiority or Other||Percentage|91.0||||||95.0|75.0|98.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.||
1711367|NCT00819156|3149128|Superiority or Other||Percentage|70.0||||||95.0|51.0|85.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter at Day 28. The 95% Confidence Interval was calculated with the Clopper-Pearson method.||
1711368|NCT00819156|3149129|Superiority or Other||Percentage|100.0||||||95.0|93.0|100.0|||||The estimated value is the percentage of patients with Testosterone (T) <=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T <=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.||
1711369|NCT00819156|3149129|Superiority or Other||Percentage|96.0||||||95.0|86.0|100.0|||||The estimated value is the percentage of patients with Testosterone (T) <=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T <=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.||
1711370|NCT00819156|3149129|Superiority or Other||Percentage|92.0||||||95.0|80.0|98.0|||||The estimated value is the percentage of patients with Testosterone (T) <=0.5 nanograms (ng)/milliliter (mL) from Day 28 to Day 364 for Patients With T <=0.5 ng/mL at Day 28. The 95% Confidence Interval was calculated by the Clopper-Pearson method.||
1711371|NCT00819156|3149130|Superiority or Other||Percentage|92.0||||||95.0|74.0|99.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.||
1711372|NCT00819156|3149130|Superiority or Other||Percentage|90.0||||||95.0|73.0|98.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.||
1711373|NCT00819156|3149130|Superiority or Other||Percentage|90.0||||||95.0|73.0|98.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.||
1711374|NCT00819156|3149130|Superiority or Other||Percentage|96.0||||||95.0|81.0|100.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.||
1711375|NCT00819156|3149130|Superiority or Other||Percentage|84.0||||||95.0|64.0|95.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.||
1711376|NCT00819156|3149130|Superiority or Other||Percentage|61.0||||||95.0|41.0|78.0|||||The estimated value is the percentage of patients with Testosterone <=0.5 nanograms/milliliter from Day 28 to Day 364. The 95% Confidence Interval was calculated by the Clopper-Pearson method.||
1711377|NCT00819091|3149131|Superiority or Other||Least Squares Mean Difference|-14.5|Standard Error of the Mean|5.6||0.0105||95.0|-25.5|-3.4|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo|
1711378|NCT00819091|3149132|Superiority or Other||Least Squares Mean Difference|-5.9|Standard Error of the Mean|4.6||0.197||95.0|-14.9|3.1|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo|
1711379|NCT00819091|3149133|Superiority or Other||Least Squares Mean Difference|-0.47||||0.0002||95.0|-0.716|-0.226|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo|
1711380|NCT00819091|3149134|Superiority or Other||Least Squares Mean Difference|-0.5|||<|0.0001||95.0|-0.72|-0.276|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo|
1711381|NCT00819091|3149135|Superiority or Other||Least Squares Mean Difference|-0.41|||<|0.0001||95.0|-0.585|-0.23|||Mixed Models Analysis|MMRM with treatment, number oral anti-diabetic drugs, week within patients, week-treatment interaction and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo|
1711382|NCT00819091|3149136|Superiority or Other||Odds Ratio (OR)|5.125||||0.0001||95.0|2.747|9.562|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo|
1711383|NCT00819091|3149137|Superiority or Other||Odds Ratio (OR)|2.653||||0.2431||95.0|0.515|13.652|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo|
1711384|NCT00819091|3149138|Superiority or Other||Odds Ratio (OR)|6.466||||0.0065||95.0|1.684|24.825|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo|
1711385|NCT00819091|3149139|Superiority or Other||Least Squares Mean Difference|-6.4|Standard Error of the Mean|5.5||0.2406||95.0|-17.2|4.3|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo|
1711419|NCT00818662|3149270|Superiority or Other||Difference in least-square means|-1.1||||0.4||95.0|-3.6|1.4|||ANCOVA||||
1711386|NCT00819091|3149140|Superiority or Other||Least Squares Mean Difference|-0.47|Standard Error of the Mean|0.12|<|0.0001||95.0|-0.7|-0.24|||ANCOVA|ANCOVA model includes treatment and number of prior oral anti-diabetic drug as fixed classification effects and baseline HbA1c as a linear covariate||Linagliptin 5.0 mg versus placebo|
1711387|NCT00819052|3149170|Superiority or Other||Mean Difference (Final Values)|-4.64||||0.7587||95.0|-34.34|25.05|||ANCOVA|Means adjusted for background ARV (Antiretroviral) stratum|||
1711388|NCT00819052|3149183|Non-Inferiority or Equivalence|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -12%|Cochran's statistic|1.0||||||95.0|-4.3|6.2|||||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.||
1711389|NCT00818883|3149227|Superiority or Other||Mean Difference (Final Values)|-2.6|||<|0.001|2-Sided|95.0|-4.1|-1.1||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.|
1711390|NCT00818883|3149227|Superiority or Other||Mean Difference (Final Values)|-3.8|||<|0.001|2-Sided|95.0|-5.5|-2.1||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.|
1711391|NCT00818883|3149228|Superiority or Other||Mean Difference (Final Values)|-4.2|||<|0.001|2-Sided|95.0|-6.4|-2.0||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.|
1711392|NCT00818883|3149228|Superiority or Other||Mean Difference (Final Values)|-5.8|||<|0.001|2-Sided|95.0|-8.4|-3.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.|
1711393|NCT00818883|3149229|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.006|2-Sided|95.0|-4.2|-0.7||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.|
1711394|NCT00818883|3149229|Superiority or Other||Mean Difference (Final Values)|-4.3|||<|0.001|2-Sided|95.0|-6.3|-2.3||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.|
1711395|NCT00818883|3149230|Superiority or Other||Mean Difference (Final Values)|-4.2||||0.001|2-Sided|95.0|-6.8|-1.7||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.|
1711396|NCT00818883|3149230|Superiority or Other||Mean Difference (Final Values)|-7.3|||<|0.001|2-Sided|95.0|-10.5|-4.2||Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.|
1711397|NCT00818883|3149231|Superiority or Other||Mean Difference (Final Values)|-2.7|||<|0.001|2-Sided|95.0|-4.1|-1.3||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.|
1711398|NCT00818883|3149231|Superiority or Other||Mean Difference (Final Values)|-3.7|||<|0.001|2-Sided|95.0|-5.2|-2.2||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.|
1711399|NCT00818883|3149232|Superiority or Other||Mean Difference (Final Values)|-5.0|||<|0.001||95.0|-7.5|-2.5||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||ANCOVA model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 10 data.|
1711400|NCT00818883|3149232|Superiority or Other||Mean Difference (Final Values)|-5.6|||<|0.001|2-Sided|95.0|-8.3|-2.9||Overall type I error rate controlled using stepwise testing procedure. First treatment test done at Week 6. If statistically significant at significance level of 5%, then treatment comparison at Week 10 was performed. Tested at 5% significance level.|ANCOVA|||Analysis of Covariance (ANCOVA) model with treatment group as a fixed effect and baseline value as a covariate was performed using Week 6 data.|
1711401|NCT00818766|3149244|Superiority or Other|||||||0.25|||||||Fisher Exact||||
1711402|NCT00818766|3149245|Superiority or Other|||||||0.25|||||||Fisher Exact||||
1711403|NCT00818766|3149247|Superiority or Other|||||||0.49|||||||Fisher Exact||||
1711404|NCT00818766|3149248|Superiority or Other||Risk Difference (RD)|-3.4||||0.21|2-Sided|95.0|-8.3|1.6|||Fisher Exact||||
1711405|NCT00818766|3149249|Superiority or Other||Risk Difference (RD)|-0.93||||0.77|2-Sided|95.0|-6.1|4.3|||Fisher Exact||||
1711406|NCT00818766|3149250|Superiority or Other||Risk Difference (RD)|-4.3||||0.26||95.0|-11.3|2.7|||Fisher Exact||||
1711407|NCT00818753|3149255|Superiority or Other||Odds Ratio (OR)|1.5||||||95.0|0.13|16.82||||||Dabigatran 150mg BID vs Heparin|
1711408|NCT00818753|3149255|Superiority or Other||Odds Ratio (OR)|1.0||||||95.0|0.08|12.76||||||Dabigatran 110mg BID vs Heparin|
1711409|NCT00818662|3149265|Superiority or Other||Difference in least-square means|-0.2||||0.351||95.0|-0.5|0.2|||ANCOVA||||
1711410|NCT00818662|3149265|Superiority or Other||Difference in least-square means|-0.1||||0.588||95.0|-0.4|0.2|||ANCOVA||||
1711411|NCT00818662|3149266|Superiority or Other||Difference in least-square means|-1.6||||0.892||95.0|-25.4|22.1|||ANCOVA||||
1711412|NCT00818662|3149266|Superiority or Other||Difference in least-square means|-15.2||||0.191||95.0|-38.0|7.7|||ANCOVA||||
1711413|NCT00818662|3149267|Superiority or Other||Difference in least-square means|-2.1||||0.7||95.0|-13.1|8.8|||ANCOVA||||
1711414|NCT00818662|3149267|Superiority or Other||Difference in least-square means|-1.5||||0.783||95.0|-12.2|9.2|||ANCOVA||||
1711415|NCT00818662|3149268|Superiority or Other||Difference in least-square means|0.4||||0.555||95.0|-1.0|1.9|||ANCOVA||||
1711420|NCT00818662|3149270|Superiority or Other||Difference in least-square means|1.5||||0.238||95.0|-1.0|4.0|||ANCOVA||||
1711421|NCT00818662|3149271|Superiority or Other||Difference in least-square means|0.1||||0.744||95.0|-0.4|0.6|||ANCOVA||||
1711422|NCT00818662|3149271|Superiority or Other||Difference in least-square means|0.4||||0.173||95.0|-0.2|0.9|||ANCOVA||||
1711423|NCT00818662|3149272|Superiority or Other||Difference in least-square means|0.0||||0.998||95.0|-0.6|0.6|||ANCOVA||||
1711424|NCT00818662|3149272|Superiority or Other||Difference in least-square means|0.4||||0.167||95.0|-0.2|1.0|||ANCOVA||||
1711425|NCT00818662|3149273|Superiority or Other||Difference in least-square means|-1.0||||0.123||95.0|-2.2|0.3|||ANCOVA||||
1711426|NCT00818662|3149273|Superiority or Other||Difference in least-square means|-1.1||||0.096||95.0|-2.3|0.2|||ANCOVA||||
1711427|NCT00818662|3149274|Superiority or Other||Difference in least-square means|1.1||||0.094||95.0|-0.2|2.3|||ANCOVA||||
1711428|NCT00818662|3149274|Superiority or Other||Difference in least-square means|1.1||||0.093||95.0|-0.2|2.3|||ANCOVA||||
1711429|NCT00818662|3149275|Superiority or Other||Difference in least-square means|2.5||||0.075||95.0|-0.3|5.3|||ANCOVA||||
1711430|NCT00818662|3149275|Superiority or Other||Difference in least-square means|0.7||||0.64||95.0|-2.1|3.4|||ANCOVA||||
1711431|NCT00818662|3149276|Superiority or Other||Difference in least-square means|-1.4||||0.331||95.0|-4.3|1.5|||ANCOVA||||
1711432|NCT00818662|3149276|Superiority or Other||Difference in least-square means|1.9||||0.206||95.0|-1.0|4.8|||ANCOVA||||
1711433|NCT00818662|3149277|Superiority or Other||Difference in least-square means|0.0||||0.766||95.0|-0.2|0.3|||Mixed Models Analysis||||
1711434|NCT00818662|3149277|Superiority or Other||Difference in least-square means|-0.1||||0.66||95.0|-0.3|0.2|||Mixed Models Analysis||||
1711435|NCT00818662|3149278|Superiority or Other||Difference in least-square means|0.3||||0.028||95.0|0.0|0.5|||Mixed Models Analysis||||
1711436|NCT00818662|3149278|Superiority or Other||Difference in least-square means|0.1||||0.306||95.0|-0.1|0.3|||Mixed Models Analysis||||
1711437|NCT00818662|3149279|Superiority or Other||Difference in least-square means|-0.2||||0.851||95.0|-2.3|1.9|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)||
1711438|NCT00818662|3149279|Superiority or Other||Difference in least-square means|0.3||||0.778||95.0|-1.8|2.4|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADCS-ADL and education level (in years)||
1711439|NCT00818662|3149280|Superiority or Other||Difference in least-square means|0.8||||0.319||95.0|-0.8|2.4|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)||
1711440|NCT00818662|3149280|Superiority or Other||Difference in least-square means|-0.7||||0.368||95.0|-2.3|0.8|||ANCOVA||Estimated within a ANCOVA model accounting for the fixed effect of treatment, E4 allele of apolipoprotein E carrier status, and for the continuous covariates age at baseline, baseline ADAS-Cog and education level (in years)||
1711441|NCT00818662|3149281|Superiority or Other||Difference in least-square means|-0.9||||0.602||95.0|-4.3|2.5|||ANCOVA||Results combined from 100 imputations from estimates & standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, & continuous covariates age at baseline, baseline ADAS-Cog & education level||
1711442|NCT00818662|3149281|Superiority or Other||Difference in least-square means|0.4||||0.812||95.0|-2.9|3.7|||ANCOVA||Results combined from 100 imputations from estimates & standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, & continuous covariates age at baseline, baseline ADAS-Cog & education level||
1711443|NCT00818662|3149282|Superiority or Other||Difference in least-square means|0.7||||0.53||95.0|-1.6|3.0|||ANCOVA||Results combined from 100 imputations from estimates & standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, & continuous covariates age at baseline, baseline ADAS-Cog & education level||
1711444|NCT00818662|3149282|Superiority or Other||Difference in least-square means|-0.8||||0.476||95.0|-3.1|1.5|||ANCOVA||Results combined from 100 imputations from estimates & standard errors from 100 ANCOVA results for fixed effect of treatment, E4 allele of apolipoprotein E carrier status, & continuous covariates age at baseline, baseline ADAS-Cog & education level||
1711445|NCT00818623|3149288|Superiority or Other|||||||0.131|||||||Log Rank||||
1711446|NCT00818623|3149289|Superiority or Other|||||||0.033|||||||Log Rank||||
1711447|NCT00818623|3149290|Superiority or Other|||||||0.0866|||||||Log Rank||||
1711448|NCT00818623|3149291|Superiority or Other||Percentage of participants castrated|70.4||||||95.0|49.4|83.9||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.|
1711449|NCT00818623|3149291|Superiority or Other||Percentage of participants castrated|50.0||||||95.0|29.1|67.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.|
1711450|NCT00818623|3149291|Superiority or Other||Percentage of participants castrated|82.0||||||95.0|58.8|92.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.|
1711451|NCT00818623|3149291|Superiority or Other||Percentage of participants castrated|49.4||||||95.0|28.3|67.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.|
1711452|NCT00818623|3149291|Superiority or Other||Percentage of participants castrated|83.3||||||95.0|61.5|93.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.|
1711453|NCT00818623|3149291|Superiority or Other||Percentage of participants castrated|32.7||||||95.0|8.3|60.6||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.|
1711454|NCT00818623|3149291|Superiority or Other||Percentage of participants castrated|38.1||||||95.0|12.1|64.3||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.|
1711455|NCT00818623|3149291|Superiority or Other||Percentage of participants castrated|45.8||||||95.0|25.6|64.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 84 days.|
1711456|NCT00818623|3149291|Superiority or Other|||||||0.0031|||||||Kruskal-Wallis||||
1711457|NCT00818623|3149292|Superiority or Other||Percentage of participants castrated|88.9||||||95.0|69.4|96.3||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.|
1711458|NCT00818623|3149292|Superiority or Other||Percentage of participants castrated|62.5||||||95.0|40.3|78.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.|
1711459|NCT00818623|3149292|Superiority or Other||Percentage of participants castrated|95.7||||||95.0|72.9|99.4||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.|
1711460|NCT00818623|3149292|Superiority or Other||Percentage of participants castrated|75.0||||||95.0|52.6|87.9||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.|
1711461|NCT00818623|3149292|Superiority or Other||Percentage of participants castrated|100.0||||||95.0|85.8|100.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.|
1711462|NCT00818623|3149292|Superiority or Other||Percentage of participants castrated|54.5||||||95.0|22.9|78.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.|
1711463|NCT00818623|3149292|Superiority or Other||Percentage of participants castrated|66.7||||||95.0|33.7|86.0||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.|
1711464|NCT00818623|3149292|Superiority or Other||Percentage of participants castrated|87.5||||||95.0|66.1|95.8||||||Percentage of participants castrated (testosterone ≤0.5 ng/mL) for at least 28 days.|
1711465|NCT00818623|3149292|Superiority or Other|||||||0.0014|||||||Kruskal-Wallis||||
1711466|NCT00818623|3149293|Superiority or Other|||||||5.86e-05|||||||Log Rank||||
1711467|NCT00818454|3149307|Superiority or Other|||||||0.0003|||||||Mixed Models Analysis|Adjusted for baseline, period, week, and treatment by week interaction|||
1711468|NCT00818454|3149308|Superiority or Other|||||||0.0001|||||||Mixed Models Analysis|Adjusted for baseline, period, week, and treatment by week interaction|||
1711469|NCT00818454|3149309|Non-Inferiority or Equivalence|Enter additional comments here, if non-inferiority or equivalence analysis||||||0.6787|||||||MMRM ANCOVA||||
1711470|NCT00818454|3149310|Superiority or Other|||||||0.3631|||||||MMRM ANCOVA||||
1711471|NCT00818454|3149311|Superiority or Other|||||||0.6591|||||||MMRM ANCOVA||||
1711472|NCT00818454|3149312|Superiority or Other|||||||0.5098|||||||MMRM ANCOVA||||
1711473|NCT00818454|3149313|Superiority or Other|||||||0.8278|||||||MMRM ANCOVA||||
1711474|NCT00818454|3149314|Superiority or Other|||||||0.159|||||||MMRM ANCOVA||||
1711475|NCT00818454|3149315|Superiority or Other||||||<|0.0001|||||||MMRM ANCOVA||||
1711476|NCT00818454|3149316|Superiority or Other||||||<|0.0001|||||||MMRM ANCOVA||||
1711477|NCT00818324|3149331|Superiority or Other||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 52.|t-test, 2 sided||||
1711478|NCT00818324|3149331|Superiority or Other||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 28.|t-test, 2 sided||||
1711479|NCT00818324|3149331|Superiority or Other||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 4.|t-test, 2 sided||||
1711480|NCT00818324|3149331|Superiority or Other||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 2.|t-test, 2 sided||||
1711481|NCT00818324|3149332|Superiority or Other||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 52.|t-test, 2 sided||||
1711482|NCT00818324|3149332|Superiority or Other||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 28.|t-test, 2 sided||||
1711483|NCT00818324|3149332|Superiority or Other||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 4.|t-test, 2 sided||||
1711484|NCT00818324|3149332|Superiority or Other||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 2|t-test, 2 sided||||
1711485|NCT00818246|3149348|Superiority or Other||Mean Difference (Final Values)|13.4|Standard Error of the Mean|2.8|<|0.0001|||||||ANCOVA|analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.||Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.|
1711486|NCT00818246|3149349|Superiority or Other||Mean Difference (Final Values)|0.605|Standard Error of the Mean|0.09|<|0.001|||||||ANCOVA||||
1711487|NCT00818246|3149350|Superiority or Other||Mean Difference (Final Values)|14.94|Standard Error of the Mean|2.68|<|0.0001|||||||ANCOVA|analysis of covariance (ANCOVA) was used to assess statistical differences between the LED-treated and untreated sides taking into account Age.||Sample sizes and power calculations were generated according to the primary outcome measures of the study. In order to have a 98% chance of detecting as significant (at the two sided 5% level) a 10% difference between the treated and untreated/control sides in the Ra and Rz post-treatment improvement, with an assumed standard deviation of 10, 33 subjects were required. To account for an 80% per protocol completion rate, the planned number of patients to be enrolled was 40.|
1711488|NCT00818207|3149351|Superiority or Other||Odds Ratio (OR)|1.14||||0.4551|2-Sided|95.0|0.81|1.62||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.|
1711489|NCT00818207|3149352|Superiority or Other||Odds Ratio (OR)|1.72|||<|0.0001|2-Sided|95.0|1.35|2.2||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.|
1711623|NCT00813150|3150064|Superiority or Other||Hazard Ratio (HR)|0.85||||0.645|2-Sided|95.0|0.41|1.73|||Regression, Cox||||
1711490|NCT00818207|3149353|Superiority or Other||Odds Ratio (OR)|1.19||||0.4388|2-Sided|95.0|0.76|1.87||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 52 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.|
1711491|NCT00818207|3149353|Superiority or Other||Odds Ratio (OR)|1.25||||0.2979|2-Sided|95.0|0.82|1.9||p-value was not adjusted for multiple comparisons.|Regression, Logistic|||Week 39 odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.|
1711492|NCT00818207|3149354|Superiority or Other||Odds Ratio (OR)|1.68||||0.0018|2-Sided|95.0|1.21|2.33|||Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.|
1711493|NCT00818207|3149355|Superiority or Other||Odds Ratio (OR)|1.64||||0.0007|2-Sided|95.0|1.23|2.18|||Regression, Logistic|||Odds ratios and p-values were obtained from a logistic regression model including the main effects of intervention and pooled center.|
1711494|NCT00817843|3149363|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.295||0.766||95.0|||||ANOVA|||"Between treatment difference in the change in FMD from the fasting to the post-fat load state.~Null hypothesis was that combination therapy (simvastatin/ezetimibe) would protect the FMD in the post-fat load phase and would therefore be associated with a smaller drop in FMD~Power calculation was based on the results from a pilot study. To detect a 1.0% difference between treatments with a SD of 2.7% and a power of 90% (alfa 0.05, two tailed) 80 evaluable patients were needed."|
1711495|NCT00817336|3149390|Superiority||Cohen's d|0.41||||0.41|2-Sided||||||Mixed Models Analysis||||
1711496|NCT00817336|3149391|Superiority or Other||Cohen's d|0.41||||0.31|2-Sided||||||Mixed Models Analysis||||
1711497|NCT00817336|3149392|Superiority||Cohen's d|2.3||||0.001|2-Sided||||||Mixed Models Analysis||||
1711498|NCT00817336|3149393|Superiority or Other||Cohen's d|0.8||||0.02|2-Sided||||||Mixed Models Analysis||||
1711499|NCT00817063|3149410|Superiority||Mean Difference (Net)|0.497||||0.089|2-Sided|95.0|-0.077|1.071||The analysis of covariance model includes treatment, age at Baseline, gender, menopausal status of females, baseline BMD score and duration of treatment exposure (<12weeks, >=12 weeks) as covariates.|ANCOVA|||Femur BMD|
1711500|NCT00817063|3149410|Superiority||Mean Difference (Net)|0.489||||0.179|2-Sided|95.0|-0.226|1.204||The analysis of covariance model includes treatment, age at Baseline, gender, menopausal status of females, baseline BMD score and duration of treatment exposure (<12weeks, >=12 weeks) as covariates.|ANCOVA|||Lumbar Spine BMD|
1711501|NCT00817063|3149419|Superiority||||||<|0.001|||||||Log Rank||||
1711502|NCT00817063|3149420|Superiority|||||||0.068|||||||Log Rank||||
1711503|NCT00817063|3149421|Superiority|||||||0.047|||||||Log Rank||||
1711504|NCT00817063|3149422|Superiority||Mean Difference (Net)|-22.36|||<|0.001|2-Sided|95.0|-31.0|-13.73|||Kruskal-Wallis||||
1711505|NCT00817063|3149423|Superiority||Difference in Percentage|25.5|||<|0.001|2-Sided|95.0|18.7|32.3|||Chi-squared, Corrected||||
1711506|NCT00817063|3149423|Superiority||Odds Ratio (OR)|4.05|||<|0.001|2-Sided|95.0|2.71|6.07|||Chi-squared, Corrected||||
1711507|NCT00817063|3149424|Superiority||Mean Difference (Net)|-24.13|||<|0.001|2-Sided|95.0|-30.4|-17.85|||Kruskal-Wallis||||
1711508|NCT00817063|3149425|Superiority||Difference in Percentage|24.8|||<|0.001|2-Sided|95.0|18.0|31.7|||Chi-squared, Corrected||||
1711509|NCT00817063|3149425|Superiority||Odds Ratio (OR)|3.78|||<|0.001|2-Sided|95.0|2.55|5.62|||Chi-squared, Corrected||||
1711510|NCT00816829|3149434|Superiority or Other|||||||0.401|||||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.|
1711511|NCT00816829|3149435|Superiority or Other|||||||0.264|||||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.|
1711512|NCT00816829|3149436|Superiority or Other|||||||0.333|||||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.|
1711513|NCT00816829|3149437|Superiority or Other|||||||0.521|||||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.|
1711514|NCT00816829|3149438|Superiority or Other|||||||0.533|||||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.|
1711515|NCT00816829|3149439|Superiority or Other|||||||0.114|||||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.|
1711516|NCT00816829|3149440|Superiority or Other|||||||0.199|||||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.|
1711517|NCT00816829|3149441|Superiority or Other|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Comparison between groups was performed using Wilcoxon Test on data at one month after the start of the treatment.|
1711518|NCT00816829|3149442|Superiority or Other|||||||0.203|||||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.|
1711519|NCT00816829|3149443|Superiority or Other|||||||0.048|||||||ANCOVA|||Comparison between groups was performed using an ANCOVA on log-transformed data at one month after the start of the treatment.|
1711520|NCT00816556|3149457|Superiority or Other|||||||0.02|||||||ANOVA|||Week 2 vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.|
1711521|NCT00816556|3149457|Superiority or Other|||||||0.32|||||||ANOVA|||Baseline vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.|
1711522|NCT00816556|3149457|Superiority or Other|||||||0.007|||||||ANOVA|||Baseline vs. week 2: P-value for the global F-test testing for all treatment arm effects equal.|
1711523|NCT00816556|3149458|Superiority or Other|||||||0.58|||||||ANOVA|||Week 2 vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.|
1711524|NCT00816556|3149458|Superiority or Other|||||||0.99|||||||ANOVA|||Baseline vs. week 12: P-value for the global F-test testing for all treatment arm effects equal.|
1711624|NCT00813150|3150065|Superiority or Other||Hazard Ratio (HR)|0.71||||0.196|2-Sided|95.0|0.43|1.19|||Regression, Cox||||
1711525|NCT00816556|3149458|Superiority or Other|||||||0.33|||||||ANOVA|||Baseline vs. week 2: P-value for the global F-test testing for all treatment arm effects equal.|
1711526|NCT00816556|3149459|Superiority or Other|||||||0.67|||||||ANOVA|||Burning bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.|
1711527|NCT00816556|3149459|Superiority or Other|||||||0.46|||||||ANOVA|||Burning severity: P-value for the global F-test testing for all treatment arm effects equal.|
1711528|NCT00816556|3149459|Superiority or Other|||||||0.27|||||||ANOVA|||Itching bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.|
1711529|NCT00816556|3149459|Superiority or Other|||||||0.37|||||||ANOVA|||Itching severity: P-value for the global F-test testing for all treatment arm effects equal.|
1711530|NCT00816556|3149459|Superiority or Other|||||||0.22|||||||ANOVA|||Dryness bothersomeness: P-value for the global F-test testing for all treatment arm effects equal.|
1711531|NCT00816556|3149459|Superiority or Other|||||||0.42|||||||ANOVA|||Dryness severity: P-value for the global F-test testing for all treatment arm effects equal.|
1711532|NCT00816023|3149509|Superiority or Other|||||||0.474|||||||Jonckheere-Terpstra||||
1711533|NCT00815776|3149523|Superiority or Other|||||||0.2995||||||From the pilot study, 50 subjects (CID arm) and 25 (exercise arm) were required for at least 80% power to detect a difference in the mean reduction in CMI scores between arms if muPassive is less than approximately 70% of that in the CID arm.|t-test, 2 sided|||A significant p-value for the treatment group effect would indicate that the CID group and Exercise group were significantly different, based on results of a two-sided t test for difference in means, with alpha=0.5, and allowing for unequal sample sizes.|
1711534|NCT00815776|3149524|Non-Inferiority or Equivalence|Safety analyses were performed on the ITT population.||||||0.688|||||||t-test, 1 sided|||Safety analyses were performed on the ITT population. The safety of the CID was characterized by the proportion of subjects with all serious and non-serious study-related adverse events and Unanticipated Adverse Device Events (UADEs). In addition, summaries of the onset, duration, severity, treatment relatedness, and outcome of all adverse events were reported.|
1711535|NCT00815776|3149525|Non-Inferiority or Equivalence|The unadjusted reductions are straight arithmetic averages and are supplied for informational purposes only. The pooled variance is calculated from the unadjusted standard deviations, and the t statistic is calculated as described in Laster (2003) using an average sample size of 54 and 106 degrees of freedom.|||||<|0.0096|||||||student's t-test with 2n-2 DoF|||The LS means were used to calculate the test statistic for non-inferiority of the CID to the traditional splint device. The null hypothesis was that the reduction of CMI score for the CID is less than 80% of the reduction in the splint group. A significant p-value(< 0.05) would reject this null hypothesis in favor of the alternative hypothesis that the CID demonstrated a reduction of at least 80% of that seen in the splint group.|
1711536|NCT00815191|3149608|Non-Inferiority or Equivalence|Non-inferiority delta of 0.5°C|Mean Difference (Final Values)|0.091|||<|0.0001|2-Sided|95.0|-0.139|0.321|||ANOVA|Repeated measures ANOVA|||
1711537|NCT00814801|3149650|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.6089|2-Sided|95.0|-1.3|0.8|||Least Square Means||||
1711538|NCT00814801|3149650|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.3141|2-Sided|95.0|-1.6|0.5|||Least Square Means||||
1711539|NCT00814801|3149651|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.7942|2-Sided|95.0|-0.8|0.6|||Least Square Means||||
1711540|NCT00814801|3149651|Superiority or Other||Mean Difference (Final Values)|0.1||||0.8419|2-Sided|95.0|-0.6|0.8|||Least Square Means||||
1711541|NCT00814801|3149652|Superiority or Other||Mean Difference (Final Values)|0.5||||0.6207|2-Sided|95.0|-1.5|2.4|||Least Square Means||||
1711542|NCT00814801|3149652|Superiority or Other||Mean Difference (Final Values)|1.8||||0.0774|2-Sided|95.0|-0.2|3.7|||Least Square Means||||
1711543|NCT00814801|3149654|Superiority or Other||Mean Difference (Final Values)|-2.59|||<|0.0001|2-Sided|95.0|-3.74|-1.44|||Least Square Means||||
1711544|NCT00814801|3149654|Superiority or Other||Mean Difference (Final Values)|-1.49|||<|0.0113|2-Sided|95.0|-2.64|-0.34|||Least Square Means||||
1711545|NCT00814775|3149658|Superiority or Other||Cox Proportional Hazard|0.76||||0.45|2-Sided|95.0|0.38|1.54|||Regression, Cox||CTrach vs. Fastrach||
1711546|NCT00814775|3149659|Superiority or Other||Hazard Ratio (HR)|1.14||||0.72|2-Sided|95.0|0.55|2.37|||Regression, Cox||CTrach vs. Fastrach||
1711547|NCT00814580|3149710|Superiority or Other|||||||0.0109||||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers|Cochran-Mantel-Haenszel||||
1711548|NCT00814580|3149711|Superiority or Other|||||||0.0481||||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel||||
1711549|NCT00814580|3149712|Superiority or Other|||||||0.1618||||||Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel||||
1711550|NCT00814580|3149713|Superiority or Other||Least square mean difference|-35.6|Standard Error of the Mean|37.45||0.3427|2-Sided|95.0|-109.3|38.1||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA||||
1711551|NCT00814580|3149714|Superiority or Other||Least square mean difference|-1.3|Standard Error of the Mean|18.53||0.9441|2-Sided|95.0|-37.8|35.2||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA||||
1711552|NCT00814580|3149715|Superiority or Other||Least square mean difference|1.0|Standard Error of the Mean|12.09||0.9367|2-Sided|95.0|-22.8|24.8||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA||||
1711553|NCT00814580|3149716|Superiority or Other||Least square mean difference|-26.3|Standard Error of the Mean|16.16||0.1051|2-Sided|95.0|-58.1|5.5||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA||||
1711554|NCT00814580|3149717|Superiority or Other||Least square mean difference|-10.3|Standard Error of the Mean|8.34||0.2179|2-Sided|95.0|-26.7|6.1||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA||||
1711555|NCT00814580|3149718|Superiority or Other||Least square mean difference|-5.6|Standard Error of the Mean|5.53||0.3097|2-Sided|95.0|-16.5|5.3||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA||||
1711556|NCT00814580|3149719|Superiority or Other||Least square mean difference|-9.3|Standard Error of the Mean|28.13||0.7405|2-Sided|95.0|-64.7|46.0||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA||||
1711557|NCT00814580|3149720|Superiority or Other||Least square mean difference|6.6|Standard Error of the Mean|9.34||0.4811|2-Sided|95.0|-11.8|25.0||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA||||
1711558|NCT00814580|3149721|Superiority or Other|||||||0.2158||||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel||||
1711559|NCT00814580|3149722|Superiority or Other|||||||0.4498||||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel||||
1711560|NCT00814580|3149723|Superiority or Other|||||||0.2633||||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel||||
1711561|NCT00814580|3149724|Superiority or Other|||||||0.9078||||||Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.|Cochran-Mantel-Haenszel||||
1711562|NCT00814580|3149725|Superiority or Other|||||||0.8524|||||||Log Rank||||
1711563|NCT00814580|3149726|Superiority or Other|||||||0.7306|||||||Log Rank||||
1711564|NCT00814580|3149727|Non-Inferiority or Equivalence|Primary hypothesis test for non-inferiority of tapentadol IR over oxycodone IR required that upper limit of 95% CI for LS mean difference (oxycodone IR minus tapentadol IR) was less than the inferiority margin (< 72). If the upper limit was less than 0 then tapentadol IR was superior to oxycodone IR for SPID over 3 days at a 5% level of significance.|Least square mean difference|9.0|Standard Error of the Mean|14.2||0.5265|2-Sided|95.0|-18.9|36.9||Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.|ANCOVA|||Tapentadol IR versus Oxycodone IR|
1711565|NCT00814320|3149842|Superiority or Other||Poisson|0.025|||<|0.0001|1-Sided|99.0||0.046||Testing the null hypothesis of 1 VASBI/year against a one-sided alternative at the 0.01 level of statistical significance.|Poisson|||For SC Administration of IGIV, 10%, with rHuPH20 after ramp-up, only|
1711566|NCT00814307|3149885|Superiority or Other||Percent difference|1.31||||0.6193|2-Sided|95.0|-3.85|6.46||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.|
1711567|NCT00814307|3149885|Superiority or Other||Percent difference|5.24||||0.0728|2-Sided|95.0|-0.49|10.96||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.|Normal Approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.|
1711568|NCT00814307|3149886|Superiority or Other||Least squares mean difference|-0.31|||<|0.0001|2-Sided|95.0|-0.43|-0.2||A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and comparison of 5 mg to placebo in ACR20 had to be statistically significant.|Linear mixed effect model|||p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.|
1711569|NCT00814307|3149886|Superiority or Other||Least squares mean difference|-0.38|||<|0.0001|2-Sided|95.0|-0.5|-0.27||A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in ACR20 had to be significant.|Linear mixed effect model|||p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.|
1711570|NCT00814307|3149887|Superiority or Other||Percent difference|33.08|||<|0.0001|2-Sided|95.0|23.04|43.13||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.|
1711571|NCT00814307|3149887|Superiority or Other||Percent difference|39.04|||<|0.0001|2-Sided|95.0|29.12|48.95||A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.|Normal approximation|||Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.|
1711572|NCT00814138|3149902|Superiority or Other||Mean Difference (Final Values)|-3.3||||0.09|2-Sided|95.0|-7.1|0.5|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.|
1711573|NCT00814138|3149903|Superiority or Other||Mean Difference (Final Values)|-1.5||||0.21|2-Sided|95.0|-3.7|0.8|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.|
1711574|NCT00814138|3149904|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.82|2-Sided|95.0|-7.2|5.4|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.|
1711575|NCT00814138|3149905|Superiority or Other||Mean Difference (Final Values)|-2.2||||0.28|2-Sided|95.0|-6.3|1.8|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.|
1711576|NCT00814138|3149906|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.29|2-Sided|95.0|-4.9|1.5|||t-test, 2 sided|||If a study participant terminated, their last results were pulled forward.|
1711577|NCT00814138|3149907|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.26|2-Sided|95.0|-9.7|5.8|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.|
1711578|NCT00814138|3149908|Superiority or Other||Mean Difference (Final Values)|-488.0||||0.26|2-Sided|95.0|-2443.4|1467.3|||Wilcoxon (Mann-Whitney)|||If a study participant terminated, their last results were pulled forward.|
1711579|NCT00813995|3149913|Superiority or Other||||||<|0.001||||||Pairwise comparison|ANCOVA||||
1711580|NCT00813943|3149927|Superiority or Other||Hazard Ratio (HR)|0.858||||0.3771|2-Sided|95.0|0.612|1.204||P-value is not adjusted for multiple testing.|Log Rank||||
1711581|NCT00813943|3149927|Superiority or Other||Hazard Ratio (HR)|0.686||||0.0328|2-Sided|95.0|0.484|0.972||P-value is not adjusted for multiple testing.|Log Rank||||
1711582|NCT00813917|3149928|Superiority or Other|||||||0.126||||||For this randomized phase II we used a one sided test with a false positive(type I error)rate of 0.20 to assess whether additional studies of the experimental arm are warranted.|Chi-squared|1 sided||Data were compared between treatment groups using Chi Square test.|
1711583|NCT00813709|3150000|Superiority or Other|||||||0.629|||||||Log Rank||||
1711584|NCT00813709|3150000|Superiority or Other|||||||0.263|||||||Log Rank||||
1711585|NCT00813709|3150000|Superiority or Other|||||||0.205|||||||Log Rank||||
1711586|NCT00813709|3150001|Superiority or Other||Hazard Ratio (HR)|0.993||||0.941|2-Sided|95.0|0.654|1.51|||Log Rank||||
1711587|NCT00813709|3150001|Superiority or Other||Hazard Ratio (HR)|0.573||||0.006|2-Sided|95.0|0.391|0.839|||Log Rank||||
1711588|NCT00813709|3150001|Superiority or Other||Hazard Ratio (HR)|0.555||||0.002|2-Sided|95.0|0.378|0.816|||Log Rank||||
1711589|NCT00813488|3150017|Superiority or Other||Odds Ratio (OR)|1.3334|||<|0.0001|2-Sided|95.0|1.2|1.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.|
1711590|NCT00813488|3150018|Superiority or Other||Odds Ratio (OR)|1.6033|||<|0.0001|2-Sided|95.0|1.4|1.8|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.|
1711591|NCT00813488|3150019|Superiority or Other||Odds Ratio (OR)|1.059||||0.8444|2-Sided|95.0|0.6|1.9|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1711592|NCT00813488|3150020|Superiority or Other||Odds Ratio (OR)|1.5826||||0.0074|2-Sided|95.0|1.1|2.2|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1711593|NCT00813488|3150021|Superiority or Other||Odds Ratio (OR)|1.5118||||0.0012||95.0|1.2|1.9|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1711594|NCT00813488|3150022|Superiority or Other||Odds Ratio (OR)|1.4269||||0.0038|2-Sided|95.0|1.1|1.8|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1711595|NCT00813488|3150023|Superiority or Other||Odds Ratio (OR)|1.1366||||0.4253|2-Sided|95.0|0.8|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1711596|NCT00813488|3150024|Superiority or Other||Odds Ratio (OR)|0.986||||0.9567|2-Sided|95.0|0.6|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1711597|NCT00813488|3150025|Superiority or Other||Odds Ratio (OR)|0.8434||||0.5777|2-Sided|95.0|0.5|1.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1711598|NCT00813488|3150026|Superiority or Other||Odds Ratio (OR)|1.3722||||0.3099|2-Sided|95.0|0.7|2.5|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1711599|NCT00813488|3150027|Superiority or Other||Odds Ratio (OR)|1.5828||||0.0372|2-Sided|95.0|1.0|2.4|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1711600|NCT00813488|3150028|Superiority or Other||Odds Ratio (OR)|1.5745||||0.0007|2-Sided|95.0|1.2|2.0|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1711601|NCT00813488|3150029|Superiority or Other||Odds Ratio (OR)|1.2544||||0.0407|2-Sided|95.0|1.0|1.6|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1711602|NCT00813488|3150030|Superiority or Other||Odds Ratio (OR)|1.0704||||0.6545|2-Sided|95.0|0.8|1.4|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1711621|NCT00813319|3150056|Superiority or Other||||||>|0.05|||||||Chi-squared|||This comparison is for participants in the Girls OnGuard/HPV Awareness condition compared to the General Health Promotion condition|
1711622|NCT00813150|3150063|Superiority or Other|||||||0.814|||||||Fisher Exact||||
1711603|NCT00813488|3150031|Superiority or Other||Odds Ratio (OR)|1.1464||||0.7012|2-Sided|95.0|0.6|2.3|||Generalized Estimating Equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1711604|NCT00813488|3150033|Superiority or Other||Mean Difference (Final Values)|0.74|Standard Error of the Mean|0.2|<|0.0001||95.0|0.58|0.9||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA||||
1711605|NCT00813488|3150034|Superiority or Other|||||||0.0018|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.|||
1711606|NCT00813488|3150035|Superiority or Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.|||
1711607|NCT00813488|3150036|Superiority or Other|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.|||
1711608|NCT00813488|3150037|Superiority or Other|||||||0.0443|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.|||
1711609|NCT00813488|3150038|Superiority or Other|||||||0.0981|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.|||
1711610|NCT00813488|3150039|Superiority or Other|||||||0.5575|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.|||
1711611|NCT00813488|3150040|Superiority or Other||Mean Difference (Final Values)|0.82|||<|0.0001|2-Sided|95.0|0.55|1.1|||ANOVA||||
1711612|NCT00813488|3150041|Superiority or Other||Mean Difference (Final Values)|0.37|||<|0.0001|2-Sided|95.0|0.25|0.5|||ANOVA||||
1711613|NCT00813488|3150048|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.15||0.0002|2-Sided|95.0|0.08|0.27||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.|
1711614|NCT00813488|3150049|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|0.18|0.37||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.|
1711615|NCT00813488|3150050|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|0.21|0.4||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID30 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.|
1711616|NCT00813488|3150051|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.05||0.0106|2-Sided|95.0|0.01|0.11||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.|
1711617|NCT00813488|3150052|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.02||0.2242|2-Sided|95.0|-0.01|0.05||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.|
1711618|NCT00813488|3150053|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.09||0.0004|2-Sided|95.0|0.06|0.2|||Mixed effects ANOVA crossover model|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.|
1711619|NCT00813319|3150054|Superiority or Other||||||=|0|||||||Chi-squared|Degrees of freedom = 2||This comparison is for total doses received (26 in Girls OnGuard/HPV Awareness condition compared to 17 in General Health Promotion condition)|
1711620|NCT00813319|3150055|Superiority or Other||||||=|0|||||||Chi-squared||||
1711625|NCT00813150|3150066|Superiority or Other||Hazard Ratio (HR)|0.71||||0.196|2-Sided|95.0|0.43|1.19|||Regression, Cox|||Null Hypothesis: The (median) time to progression is equal in both treatment groups|
1711626|NCT00812981|3150091|Non-Inferiority or Equivalence|Non-inferiority was defined as the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio of HI antibodies against the A/Indonesia/05/2005 strain between the two groups (1562902A CP Group over 1562902A NP Group), being below (<) 2.0.|Adjusted GMT ratio|0.84|||||2-Sided|95.0|0.71|0.99||||||Difference in adjusted GMT ratio for HI antibodies: To demonstrate that the NP 1562902A vaccine was non-inferior to the CP 1562902A vaccine, with respect to HI antibody GMT against the A/Indonesia/05/2005 strain, 42 days following vaccination.|
1711627|NCT00812929|3150135|Superiority||Hazard Ratio (HR)|6.07|||||2-Sided|95.0|2.9|12.71|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours|
1711628|NCT00812929|3150135|Superiority||Hazard Ratio (HR)|2.03|||||2-Sided|95.0|1.07|3.87|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours|
1711629|NCT00812929|3150135|Superiority||Hazard Ratio (HR)|3.6|||||2-Sided|95.0|2.0|6.48|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours|
1711630|NCT00812929|3150135|Superiority||Hazard Ratio (HR)|1.91|||||2-Sided|95.0|1.0|3.64|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours|
1711631|NCT00812929|3150135|Superiority||Hazard Ratio (HR)|5.49|||||2-Sided|95.0|2.75|10.94|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours|
1711632|NCT00812929|3150135|Superiority||Hazard Ratio (HR)|2.09|||||2-Sided|95.0|1.19|3.69|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours|
1711633|NCT00812929|3150135|Superiority||Hazard Ratio (HR)|1.67|||||2-Sided|95.0|0.86|3.25|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours|
1711634|NCT00812929|3150135|Superiority||Hazard Ratio (HR)|1.93|||||2-Sided|95.0|1.01|3.66|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours|
1711635|NCT00812929|3150135|Superiority||Hazard Ratio (HR)|1.42|||||2-Sided|95.0|0.81|2.48|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours|
1711636|NCT00812929|3150135|Superiority||Hazard Ratio (HR)|1.78|||||2-Sided|95.0|0.93|3.43|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|24 Hours|
1711637|NCT00812929|3150135|Superiority||Hazard Ratio (HR)|1.1|||||2-Sided|95.0|0.59|2.06|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|9.5 Hours|
1711638|NCT00812929|3150135|Superiority||Hazard Ratio (HR)|1.25|||||2-Sided|95.0|0.71|2.21|||||Hazard ratio = ratio of likelihood of recovery at any time on active treatment vs placebo|2 Hours|
1711639|NCT00812929|3150136|Superiority||Mean Difference (Net)|1.72|Standard Error of the Mean|0.872|||2-Sided|95.0|0.0|3.44|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours|
1711640|NCT00812929|3150136|Superiority||Mean Difference (Net)|2.11|Standard Error of the Mean|0.877|||2-Sided|95.0|0.38|3.84|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours|
1711641|NCT00812929|3150136|Superiority||Mean Difference (Net)|3.17|Standard Error of the Mean|1.169|||2-Sided|95.0|0.86|5.48|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours|
1711642|NCT00812929|3150136|Superiority||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.874|||2-Sided|95.0|-1.83|1.62|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours|
1711643|NCT00812929|3150136|Superiority||Mean Difference (Net)|3.3|Standard Error of the Mean|0.879|||2-Sided|95.0|1.57|5.03|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours|
1711644|NCT00812929|3150136|Superiority||Mean Difference (Net)|1.51|Standard Error of the Mean|1.171|||2-Sided|95.0|-0.8|3.82|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours|
1711645|NCT00812929|3150136|Superiority||Mean Difference (Net)|0.18|Standard Error of the Mean|0.873|||2-Sided|95.0|-1.55|1.9|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours|
1711646|NCT00812929|3150136|Superiority||Mean Difference (Net)|1.22|Standard Error of the Mean|0.878|||2-Sided|95.0|-0.51|2.95|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours|
1711647|NCT00812929|3150136|Superiority||Mean Difference (Net)|1.12|Standard Error of the Mean|1.169|||2-Sided|95.0|-1.19|3.43|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours|
1711648|NCT00812929|3150136|Superiority||Mean Difference (Net)|0.9|Standard Error of the Mean|0.873|||2-Sided|95.0|-0.82|2.63|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|24 Hours|
1711649|NCT00812929|3150136|Superiority||Mean Difference (Net)|0.07|Standard Error of the Mean|0.878|||2-Sided|95.0|-1.66|1.8|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|9.5 Hours|
1711650|NCT00812929|3150136|Superiority||Mean Difference (Net)|0.94|Standard Error of the Mean|1.17|||2-Sided|95.0|-1.37|3.25|||||Estimates and 95% confidence intervals for treatment difference between each active dose and placebo for each challenge time point were calculated.|2 Hours|
1711651|NCT00812929|3150137|Superiority||Mean Difference (Net)|2.27|Standard Error of the Mean|1.245|||2-Sided|95.0|-0.19|4.73||||||9.5 Hours|
1711652|NCT00812929|3150137|Superiority||Mean Difference (Net)|6.3|Standard Error of the Mean|1.637|||2-Sided|95.0|3.06|9.54||||||2 Hours|
1711653|NCT00812929|3150137|Superiority||Mean Difference (Net)|3.49|Standard Error of the Mean|1.248|||2-Sided|95.0|1.02|5.95||||||9.5 Hours|
1711654|NCT00812929|3150137|Superiority||Mean Difference (Net)|2.79|Standard Error of the Mean|1.639|||2-Sided|95.0|-0.45|6.03||||||2 Hours|
1711655|NCT00812929|3150137|Superiority||Mean Difference (Net)|0.76|Standard Error of the Mean|1.247|||2-Sided|95.0|-1.7|3.22||||||9.5 Hours|
1711656|NCT00812929|3150137|Superiority||Mean Difference (Net)|2.6|Standard Error of the Mean|1.637|||2-Sided|95.0|-0.64|5.84||||||2 Hours|
1711657|NCT00812929|3150137|Superiority||Mean Difference (Net)|0.12|Standard Error of the Mean|1.247|||2-Sided|95.0|-2.34|2.58||||||9.5 Hours|
1711658|NCT00812929|3150137|Superiority||Mean Difference (Net)|2.52|Standard Error of the Mean|1.638|||2-Sided|95.0|-0.72|5.75||||||2 Hours|
1711659|NCT00812929|3150138|Superiority||Mean Difference (Net)|2.53|Standard Error of the Mean|1.438|||2-Sided|95.0|-0.31|5.37|||||||
1711660|NCT00812929|3150138|Superiority||Mean Difference (Net)|0.33|Standard Error of the Mean|1.441|||2-Sided|95.0|-2.52|3.18|||||||
1711661|NCT00812929|3150138|Superiority||Mean Difference (Net)|0.53|Standard Error of the Mean|1.44|||2-Sided|95.0|-2.32|3.37|||||||
1711662|NCT00812929|3150138|Superiority||Mean Difference (Net)|1.29|Standard Error of the Mean|1.44|||2-Sided|95.0|-1.56|4.13|||||||
1711663|NCT00812877|3150146|Superiority or Other||Hazard Ratio (HR)|2.35||||0.046|2-Sided|95.0|1.19|4.66||A clustered permutation test with 10,000 random permutations based on the log rank test statistic was used for the primary treatment comparison to account for censoring and to ensure proper test size given the number of practices.|Log Rank||A confirmatory analysis, adjusted for patient, dentist, and tooth characteristics, and follow-up time, was performed using marginal proportional hazards regression with robust standard error estimates accounting for clustering by practice.||
1711664|NCT00812838|3150147|Superiority|||||||0.0286||||||Threshold for statistical significance is <0.05|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.|
1711665|NCT00812838|3150148|Superiority|||||||0.8566||||||Threshold for statistical significance was <0.05|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.|
1711666|NCT00812838|3150149|Superiority|||||||0.0166||||||This applies to 100 units of Botulinum Toxin Type A arm vs the Normal saline arm|t-test, 2 sided|||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.|
1711667|NCT00812838|3150150|Superiority|||||||0.3009||||||This applies to 100 units of Botulinum Toxin Type A arm vs the Normal saline arm|t-test, 2 sided|||"This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.~This analysis pertains to both categories"|
1711668|NCT00812838|3150151|Superiority|||||||0.5154||||||This will be a pilot study; it was assessed that 10 subjects in each arm, for a total of 20 subjects, will allow us to determine if the therapy is effective. To allow for screen failures, 45 subjects are planned for screening.|t-test, 2 sided||||
1711669|NCT00812812|3150156|Superiority or Other||Mean Difference (Net)|-4.6||||0.198|2-Sided|95.0|-11.7|2.5|||ANCOVA||Mean difference was estimated as paroxetine minus placebo.||
1711670|NCT00812461|3150189|Superiority or Other||Ratio to placebo|0.92||||0.049|2-Sided|95.0|0.84|1.0|||[Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 222 participants in the placebo group and 205 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Logtransformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.|
1711671|NCT00812461|3150190|Superiority or Other||Ratio to placebo|0.96||||0.529|2-Sided|95.0|0.86|1.08|||[Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 224 participants in the placebo group and 207 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Logtransformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.|
1711672|NCT00812461|3150191|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.11||0.111|2-Sided|95.0|-0.38|0.04|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 225 participants in the placebo group and 203 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.|
1711673|NCT00812461|3150192|Superiority or Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.11||0.029|2-Sided|95.0|-0.44|-0.02|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 225 participants in the placebo group and 203 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.|
1711674|NCT00812461|3150193|Superiority or Other||Odds Ratio (OR)|0.92||||0.63|2-Sided|95.0|0.67|1.27|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.|
1711735|NCT00811577|3150327|Superiority or Other|||||||0.37||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1714100|NCT00786864|3154192|Superiority or Other||||||p<|0|||||||ANCOVA||||
1711675|NCT00812461|3150194|Superiority or Other||Mean Difference (Final Values)|-4.95|Standard Error of the Mean|2.89||0.088|2-Sided|95.0|-10.63|0.73|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 229 participants in the placebo group and 212 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."|
1711676|NCT00812461|3150195|Superiority or Other||Mean Difference (Final Values)|-1.72|Standard Error of the Mean|0.68||0.012|2-Sided|95.0|-3.07|-0.38|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 229 participants in the placebo group and 212 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."|
1711677|NCT00812006|3150223|Superiority or Other||||||<|0.001||||||Nominal p-value was adjusted under Benjamini and Hochberg’s false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|A compound-symmetry covariance matrix was used to model the correlation among repeated measurements within a patient, due to a convergence issue.|||
1711678|NCT00812006|3150224|Superiority or Other||||||<|0.001||||||Nominal p-value was adjusted under Benjamini and Hochberg’s falsediscovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.|||
1711679|NCT00812006|3150225|Superiority or Other||||||<|0.001||||||Nominal p-value was adjusted under Benjamini and Hochberg’s false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.|||
1711680|NCT00812006|3150226|Superiority or Other||||||<|0.001||||||Nominal p-value was adjusted under Benjamini and Hochberg’s false discovery rate procedure for the multiple secondary endpoints at α=0.1 significance level.|Generalized Linear Mixed Model|A compound-symmetry covariance matrix was used to model the correlation among repeated measurements within a patient, due to a convergence issue.|||
1711681|NCT00812006|3150227|Superiority or Other||||||<|0.001|||||||Generalized Linear Mixed Model|An unstructured covariance matrix was used to model the correlation among repeated measurements within a patient.|||
1711682|NCT00811954|3150245|Non-Inferiority or Equivalence|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|9.2|||||2-Sided|97.5|5.5|12.9||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm C) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm C) in 96 week probability of tolerability failure with 97.5% confidence interval.|
1711683|NCT00811954|3150245|Non-Inferiority or Equivalence|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|3.6|||||2-Sided|97.5|1.4|5.8||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm C and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm C - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.|
1711684|NCT00811954|3150245|Non-Inferiority or Equivalence|Although the study was not specifically powered to be able to detect equivalence, equivalence was declared if the 97.5% confidence interval difference in the cumulative probability of the tolerability endpoint by 96 weeks was entirely contained within +/-10 percentage points.|Cumulative incidence difference|12.8|||||2-Sided|97.5|9.4|16.1||||||Treatment comparison was made using the methods of Gray. Inference regarding comparisons of the treatment groups (arm A and arm B) with respect to equivalence was made based on the two-sided 97.5% confidence intervals of differences (arm A - arm B) in 96 week probability of tolerability failure with 97.5% confidence interval.|
1711685|NCT00811954|3150246|Non-Inferiority or Equivalence|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|-2.2|||||2-Sided|97.5|-6.7|2.3||||||Treatment comparison was made using the difference (arm A - arm C) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.|
1711686|NCT00811954|3150246|Non-Inferiority or Equivalence|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|5.6|||||2-Sided|97.5|1.3|9.9||||||Treatment comparison was made using the difference (arm C - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.|
1711687|NCT00811954|3150246|Non-Inferiority or Equivalence|Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.|Cumulative probability difference|3.4|||||2-Sided|97.5|-0.7|7.4||||||Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.|
1714101|NCT00786864|3154193|Superiority or Other||||||p=|0|||||||ANCOVA||||
1711688|NCT00811941|3150247|Superiority or Other||Ratio to placebo|0.88||||0.037|2-Sided|95.0|0.79|0.99|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 259 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.|
1711689|NCT00811941|3150248|Superiority or Other||Ratio to placebo|0.78||||0.001|2-Sided|95.0|0.67|0.9|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 98 participants in the placebo group and 259 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.|
1711690|NCT00811941|3150249|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.12||0.029||95.0|-0.5|-0.03|||Adjusted change from Baseline to Week 52||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 95 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment by- time interactions were also included in the model. An unstructured covariance matrix was used.|
1711691|NCT00811941|3150250|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.11||0.056|2-Sided|95.0|-0.44|0.01|||Adjusted change from Baseline to Week 52||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 95 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.|
1711692|NCT00811941|3150251|Superiority or Other||Odds Ratio (OR)|1.01||||0.976|2-Sided|95.0|0.67|1.52|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.|
1711693|NCT00811941|3150252|Superiority or Other||Mean Difference (Final Values)|-6.47|Standard Error of the Mean|3.07||0.036|2-Sided|95.0|-12.53|-0.42|||Adjusted change from Baseline - Month 13||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.|
1711694|NCT00811941|3150253|Superiority or Other||Mean Difference (Final Values)|-1.57|Standard Error of the Mean|0.65||0.017|2-Sided|95.0|-2.85|-0.29|||Adjusted change from Baseline - Month 13||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 97 participants in the placebo group and 258 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.|
1711695|NCT00811941|3150254|Superiority or Other||Ratio to placebo|0.99||||0.916|2-Sided|95.0|0.9|1.1|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 108 participants in the placebo group and 318 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.|
1711696|NCT00811941|3150255|Superiority or Other||Ratio to placebo|0.93||||0.273|2-Sided|95.0|0.83|1.05|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 108 participants in the placebo group and 319 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the logtransformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.|
1711697|NCT00811941|3150256|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.11||0.217|2-Sided|95.0|-0.36|0.08|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 104 participants in the placebo group and 306 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment by- time interactions were also included in the model. An unstructured covariance matrix was used.|
1711698|NCT00811941|3150257|Superiority or Other||Mean Difference (Final Values)|-0.18|Standard Error of the Mean|0.09||0.046|2-Sided|95.0|-0.37|0.0|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 104 participants in the placebo group and 306 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.|
1711699|NCT00811941|3150258|Superiority or Other||Odds Ratio (OR)|0.92||||0.689|2-Sided|95.0|0.59|1.41|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values were imputed using individual-patient predicted values of TAC derived from the MMRM model.|
1711754|NCT00811252|3150380|Superiority or Other||Mean Difference (Final Values)|-0.56|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-0.82|-0.31||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA||||
1711700|NCT00811941|3150259|Superiority or Other||Mean Difference (Final Values)|-3.47|Standard Error of the Mean|2.9||0.232|2-Sided|95.0|-9.17|2.23|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 110 participants in the placebo group and 320 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."|
1711701|NCT00811941|3150260|Superiority or Other||Mean Difference (Final Values)|-0.88|Standard Error of the Mean|0.62||0.16|2-Sided|95.0|-2.1|0.35|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 110 participants in the placebo group and 320 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. Null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-13); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."|
1711702|NCT00811928|3150264|Superiority or Other||Percentage of Participants|5.98|||||2-Sided|95.0|2.4|11.9|||||All-Cause Mortality Rate is the percentage of participants with mortality from any cause.||
1711703|NCT00811928|3150264|Superiority or Other||Percentage of Participants|2.56|||||2-Sided|95.0|0.5|7.3|||||All-Cause Mortality Rate is the percentage of participants with mortality from any cause.||
1711704|NCT00811928|3150265|Superiority or Other||Percentage of Participants|41.88|||||2-Sided|95.0|32.8|51.4|||||IFI Incidence for the Fluconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)*100%||
1711705|NCT00811928|3150265|Superiority or Other||Percentage of Participants|31.62|||||2-Sided|95.0|23.3|40.9|||||IFI Incidence for the Posaconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)*100%.||
1711706|NCT00811928|3150268|Superiority or Other||Percentage of Participants|13.68|||||2-Sided|95.0|8.0|21.3|||||IFI Incidence for the Fluconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)*100%||
1711707|NCT00811928|3150268|Superiority or Other||Percentage of Participants|4.27|||||2-Sided|95.0|1.4|9.7|||||IFI Incidence for the Posaconazole group = (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)*100%||
1711708|NCT00811928|3150269|Non-Inferiority or Equivalence|The upper limit of the 95% Confidence Interval for the difference in incidence defined as (# of participants affected with proven or probable IFI/ # of participants in the FAS population at risk)*100% (posaconazole minus fluconazole) had to be < 4 in order to be considered non-inferior. IFI occurred: proven+probable|Difference for the incidence|-5.88|||||2-Sided|95.0|-12.21|0.25|||||Posaconazole minus fluconazole||
1711709|NCT00811733|3150298|Superiority or Other||percentage of participants|64.0|||||2-Sided|95.0|40.7|82.8|||||The estimated value represents the percentage of participants with OR.||
1711710|NCT00811733|3150298|Superiority or Other||percentage of participants|33.0|||||2-Sided|95.0|11.8|61.6|||||The estimated value represents the percentage of participants with OR.||
1711711|NCT00811733|3150299|Superiority or Other||percentage of participants|68.0|||||2-Sided|95.0|45.1|86.1|||||The estimated value represents the percentage of participants with OR.||
1711712|NCT00811733|3150299|Superiority or Other||percentage of participants|47.0|||||2-Sided|95.0|21.3|73.4|||||The estimated value represents the percentage of participants with OR.||
1711713|NCT00811720|3150300|Superiority or Other||Ratio to placebo|0.9||||0.011|2-Sided|95.0|0.84|0.98|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 209 participants in the placebo group and 158 participants in the nalmefene group.|Log-transformed ALAT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time and treatment-by-time interactions were included in the model. An unstructured covariance matrix was used.|
1711714|NCT00811720|3150301|Superiority or Other||Ratio to placebo|0.88||||0.009|2-Sided|95.0|0.8|0.97|||Adjusted values||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 211 participants in the placebo group and 158 participants in the nalmefene group.|Log-transformed GGT values were analysed using an MMRM model with the log-transformed Baseline value as a covariate, and site, sex, time in weeks, and treatment as fixed effects. Log-transformed Baseline value-by-time interaction and treatment-by-time interaction were included in the model. An unstructured covariance matrix was used.|
1711715|NCT00811720|3150302|Superiority or Other||Mean Difference (Final Values)|-0.34|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.53|-0.15|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.|MMRM model with the Baseline CGI-S score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline CGI-S score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used.|
1711716|NCT00811720|3150303|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.57|-0.16|||Adjusted change from Baseline to Week 24||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 210 participants in the placebo group and 152 participants in the nalmefene group.|MMRM model with the Baseline score as a covariate, and site, sex, time in weeks, and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model; an unstructured covariance matrix was used.|
1711717|NCT00811720|3150304|Superiority or Other||Odds Ratio (OR)|0.7||||0.039|2-Sided|95.0|0.5|0.98|||Adjusted Odds Ratio (OR) response|||The analysis of RSDRL used a logistic regression (LREG) model, with country, sex, Baseline DRL, and treatment as fixed effects, and missing values imputed as non-response.|
1711718|NCT00811720|3150305|Superiority or Other||Mean Difference (Final Values)|-10.96|Standard Error of the Mean|2.98|<|0.001|2-Sided|95.0|-16.81|-5.11|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."|
1711719|NCT00811720|3150306|Superiority or Other||Mean Difference (Final Values)|-2.33|Standard Error of the Mean|0.75||0.002|2-Sided|95.0|-3.81|-0.85|||Adjusted change from Baseline to Month 6||The Number of Participants Analyzed is participants with efficacy measurement available at this endpoint, that is, 213 participants in the placebo group and 152 participants in the nalmefene group.|"The primary hypothesis concerned the treatment effect at Month 6. The null hypothesis of no difference in treatment effect was tested against the alternative hypothesis that there was a difference in treatment effect.~MMRM model with the Baseline score as a covariate; site, sex, time in months (Month 1-6); and treatment as fixed effects. The Baseline score-by-time and treatment-by-time interactions were also included in the model. An unstructured covariance matrix was used."|
1711720|NCT00811577|3150324|Superiority or Other|||||||0.41|||||||Wilcoxon (signed rank)|||A regression analysis was run to compare alpha-SMA between 3 mg and 10 mg AZX100 and placebo, adjusted for the subject’s gender and age. GEE regression in SAS/STAT PROC GENMOD was used because it properly handled the correlations among the three observations for each subject.|
1711721|NCT00811577|3150324|Superiority or Other|||||||0.44|||||||Wilcoxon (signed rank)|||A regression analysis was run to compare alpha-SMA between 3 mg and 10 mg AZX100 and placebo, adjusted for the subject’s gender and age. GEE regression in SAS/STAT PROC GENMOD was used because it properly handled the correlations among the three observations for each subject.|
1711722|NCT00811577|3150325|Superiority or Other|||||||0.62||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.|
1711723|NCT00811577|3150325|Superiority or Other|||||||0.095||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.|
1711724|NCT00811577|3150325|Superiority or Other|||||||0.68||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.|
1711725|NCT00811577|3150325|Superiority or Other|||||||0.069||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.|
1711726|NCT00811577|3150325|Superiority or Other|||||||0.66||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.|
1711727|NCT00811577|3150325|Superiority or Other|||||||0.086||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Agreement between the two rater evaluations was assessed by tabulating the difference of the two ratings. Statistical methods for paired data were used to compare the two dosages of AZX100 to placebo.|
1711728|NCT00811577|3150326|Superiority or Other|||||||0.46||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1711729|NCT00811577|3150326|Superiority or Other|||||||0.3||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1711730|NCT00811577|3150326|Superiority or Other|||||||0.89||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1711731|NCT00811577|3150326|Superiority or Other|||||||0.69||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1711732|NCT00811577|3150326|Superiority or Other|||||||0.14||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1711733|NCT00811577|3150326|Superiority or Other|||||||0.16||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1711734|NCT00811577|3150327|Superiority or Other|||||||0.43||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1711755|NCT00811252|3150381|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-0.88|-0.32||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA||||
1711736|NCT00811577|3150327|Superiority or Other|||||||0.83||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1711737|NCT00811577|3150327|Superiority or Other|||||||0.05||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1711738|NCT00811577|3150327|Superiority or Other|||||||0.75||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1711739|NCT00811577|3150327|Superiority or Other|||||||0.77||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1711740|NCT00811577|3150327|Superiority or Other|||||||0.15||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1711741|NCT00811577|3150327|Superiority or Other|||||||0.87||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Statistical analysis included line plots of paired differences vs. time, univariate p-values from Wilcoxon signed rank tests, and repeated measures regression models in SAS/STAT PROC GENMOD.|
1711742|NCT00811577|3150328|Superiority or Other|||||||0.22||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.|
1711743|NCT00811577|3150328|Superiority or Other|||||||0.96||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.|
1711744|NCT00811577|3150328|Superiority or Other|||||||0.08||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.|
1711745|NCT00811577|3150328|Superiority or Other|||||||0.47||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using a 100 mm VAS scale, each photograph was assessed by two raters, who, in an end-of-study session, were presented with photographs in their longitudinal sequence, but blinded as to dosage group. These data were used for an inter-rater concordance analysis and also to compare the placebo, 3 and 10 mg dosages.|
1711746|NCT00811577|3150329|Superiority or Other|||||||0.8||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.|
1711747|NCT00811577|3150329|Superiority or Other|||||||0.61||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.|
1711748|NCT00811577|3150329|Superiority or Other|||||||0.56||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.|
1711749|NCT00811577|3150329|Superiority or Other|||||||0.57||||||For this early phase study, multiple comparisons adjustments were not used.|Wilcoxon (signed rank)|||Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates.|
1711750|NCT00811382|3150352|Superiority|||||||0.97|||||||Wilcoxon (Mann-Whitney)||||
1711751|NCT00811252|3150377|Superiority or Other||Odds Ratio (OR)|0.47||||0.009|2-Sided|95.0|0.27|0.83||A nominal p-value is provided. No correction for multiplicity was made.|Regression, Logistic||||
1711752|NCT00811252|3150378|Superiority or Other||Odds Ratio (OR)|0.43||||0.0008|2-Sided|95.0|0.26|0.7||A nominal p-value is provided. No correction for multiplicity was made.|Regression, Logistic||||
1711753|NCT00811252|3150379|Superiority or Other||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|0.23||0.0552|2-Sided|95.0|-0.88|0.01||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA||||
1711756|NCT00811252|3150382|Superiority or Other||Mean Difference (Final Values)|-2.35|Standard Error of the Mean|0.74||0.0015|2-Sided|95.0|-3.8|-0.91||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA||||
1711757|NCT00811252|3150383|Superiority or Other||Mean Difference (Final Values)|-4.29|Standard Error of the Mean|1.03|<|0.0001|2-Sided|95.0|-6.32|-2.26||A nominal p-value is provided. No correction for multiplicity was made.|ANCOVA||||
1711758|NCT00811252|3150384|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.56||0.7971|2-Sided|95.0|-0.95|1.24||A nominal p-value is provided.|ANCOVA||||
1711759|NCT00811252|3150384|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.55||0.4482|2-Sided|95.0|-1.49|0.66||A nominal p-value is provided.|ANCOVA||||
1711760|NCT00811252|3150385|Superiority or Other||Mean Difference (Final Values)|-1.25|Standard Error of the Mean|0.72||0.0827|2-Sided|95.0|-2.65|0.16||A nominal p-value is provided.|ANCOVA||||
1711761|NCT00811252|3150385|Superiority or Other||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.7||0.6879|2-Sided|95.0|-1.67|1.1||A nominal p-value is provided.|ANCOVA||||
1711762|NCT00811252|3150386|Superiority or Other||Mean Difference (Final Values)|-3.3|Standard Error of the Mean|0.86||0.0002|2-Sided|95.0|-4.99|-1.6||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA||||
1711763|NCT00811252|3150386|Superiority or Other||Mean Difference (Final Values)|-1.06|Standard Error of the Mean|0.85||0.2134|2-Sided|95.0|-2.72|0.61||Since p-value >0.05, hierarchically testing stopped here.|ANCOVA||||
1711764|NCT00811252|3150387|Superiority or Other||Mean Difference (Final Values)|-4.22|Standard Error of the Mean|0.96|<|0.0001|2-Sided|95.0|-6.1|-2.34||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA||||
1711765|NCT00811252|3150387|Superiority or Other||Mean Difference (Final Values)|-2.13|Standard Error of the Mean|0.94|<|0.024|2-Sided|95.0|-3.98|-0.28||Since p-value <0.05, hierarchically testing continued|ANCOVA||A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.|As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1711766|NCT00811252|3150388|Superiority or Other||Mean Difference (Final Values)|-5.48|Standard Error of the Mean|1.03|<|0.0001|2-Sided|95.0|-7.5|-3.46||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA||||
1711767|NCT00811252|3150388|Superiority or Other||Mean Difference (Final Values)|-3.32|Standard Error of the Mean|1.01|<|0.0011|2-Sided|95.0|-5.31|-1.34||Since p-value <0.05, hierarchically testing continued|ANCOVA||A statistical testing strategy was defined a priori for a single dose of vortioxetine that was tested versus placebo in the primary and key secondary efficacy analyses.|As soon as an endpoint was non-significant at the 0.05 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1711768|NCT00811187|3150389|Superiority|[Not Specified]|Mean Difference (Net)|-2.03|||<|0.001|2-Sided||||||Regression, Linear||Treatment pain difference= Lidocaine (0.97) - Placebo (3.00).|A sample size calculation and power analysis was conducted using PS Power and Sample Size Calculations 2.1.30 (Vanderbilt University, Department of Biostatistics, Nashville, TN) to determine necessary sample size.|
1711769|NCT00810888|3150448|Superiority|||||||0.25|||||||Kruskal-Wallis|||Groups 1 and 2 only the spot positive subjects randomized to interventional drug or placebo|
1711770|NCT00810888|3150449|Other|A Kappa test of overall agreement was used|Kappa|0.77|||||2-Sided|95.0|0.61|0.93|||||A kappa of >0.75 is considered excellent agreement||
1711771|NCT00810888|3150450|Superiority|||||||0.58|||||||Fisher Exact||||
1711772|NCT00810888|3150451|Superiority|||||||0.47|||||||Fisher Exact||||
1711773|NCT00810888|3150452|Superiority||Specificity|94.2||||0.004|2-Sided|95.0|85.6|98.1|||Fisher Exact||||
1711774|NCT00810888|3150453|Superiority||Sensitivity|38.5||||0.004|2-Sided|95.0|17.6|64.6|||Fisher Exact||||
1711775|NCT00810888|3150454|Superiority|||||||0.66|||||||Fisher Exact|||Only the randomized subjects will be compared|
1711776|NCT00810888|3150455|Superiority|||||||1||||||not adjusted for multiple comparisons as a prior hypothesis critical value <0.05|Fisher Exact|||Fisher's exact test|
1711777|NCT00810771|3150458|Superiority or Other|||||||0.35|||||||Chi-squared||||
1711778|NCT00810771|3150459|Superiority or Other|||||||0.576|||||||Chi-squared||||
1711779|NCT00810771|3150460|Superiority or Other|||||||0.186|||||||Chi-squared||||
1711780|NCT00810771|3150461|Superiority or Other|||||||0.002|||||||Chi-squared||||
1711781|NCT00810771|3150462|Superiority or Other|||||||0.671|||||||Chi-squared||||
1711782|NCT00810771|3150463|Superiority or Other|||||||0.873|||||||Chi-squared||||
1711783|NCT00810693|3150468|Superiority or Other|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.|
1711784|NCT00810693|3150468|Superiority or Other||Mean Difference (Final Values)|-6.17||||0.0009|2-Sided|95.0|-9.79|-2.54||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA||||
1711785|NCT00810693|3150468|Superiority or Other|||||||0.0019||||||"Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO FC, TTCW, Borg scale, EQ5D, LPH.~Primary analysis due to result of Shapiro-Wilk test. Nominally significant only due to hierarchical testing."|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy.||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 105 in case of death or clinical worsening without termination visit and with the last observed value otherwise.|
1711786|NCT00810693|3150469|Superiority or Other|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.|
1711787|NCT00810693|3150469|Superiority or Other||Mean Difference (Final Values)|0.06||||0.0197|2-Sided|95.0|0.01|0.11||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA||||
1711808|NCT00810407|3150515|Superiority or Other|||||||0.428|||||||Cochran-Armitage (EXACT)|||The factor tested was “age”. The null hypothesis was that there was no ordinal trend in the number of participants with treatment-related adverse events across the age at baseline.|
1711883|NCT00810199|3150599|Superiority or Other|||||||0.0287|||||||Wald Chi-square|Asymptotic test; parameter estimate is zero.||Week 24|
1711788|NCT00810693|3150469|Superiority or Other|||||||0.0663||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy.||Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of -0.594 in case of death or clinical worsening without termination visit and with the last observed value otherwise.|
1711789|NCT00810693|3150470|Superiority or Other|||||||0.0022||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 10 in case of death or clinical worsening without termination visit and with the last observed value otherwise.|
1711790|NCT00810693|3150471|Superiority or Other||Risk Difference (RD)|-5.2||||0.0046|2-Sided|95.0|-9.85|-0.55||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Log Rank|Test was stratified by region and therapy naive/add-on therapy|Based on Mantel-Haenszel estimate stratified by region and therapy naive/add-on therapy.|"The test is for difference of occurence of Any event."|
1711791|NCT00810693|3150472|Superiority or Other|||||||0.0033||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of IV in case of clinical worsening without termination visit or measurement at that termination visit and with a worst value of V in case of death and with the last observed value otherwise.|
1711792|NCT00810693|3150473|Superiority or Other|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.|
1711793|NCT00810693|3150473|Superiority or Other||Mean Difference (Final Values)|-431.81||||0.0157|2-Sided|95.0|-781.52|-82.1||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA||||
1711794|NCT00810693|3150473|Superiority or Other||||||<|0.0001||||||"Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.~Primary analysis due to result of Shapiro-Wilk test."|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.|
1711795|NCT00810693|3150474|Superiority or Other|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.|
1711796|NCT00810693|3150474|Superiority or Other||Mean Difference (Final Values)|-225.72|||<|0.0001|2-Sided|95.0|-281.37|-170.08||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA||||
1711797|NCT00810693|3150474|Superiority or Other||||||<|0.0001||||||Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, TTCW, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.|
1711798|NCT00810693|3150475|Superiority or Other|||||||0.0001|||||||Shapiro-Wilk|||Shapiro-Wilk test for normality of ANCOVA residuals.|
1711799|NCT00810693|3150475|Superiority or Other||Mean Difference (Final Values)|35.78|||<|0.0001|2-Sided|95.0|20.06|51.51||Additional analysis due to result of Shapiro-Wilk test.|ANCOVA||||
1711800|NCT00810693|3150475|Superiority or Other||||||<|0.0001||||||Prespecified significance level for all significance tests was 5%. Primary analysis due to result of Shapiro-Wilk test.|Wilcoxon (Mann-Whitney)|Test was stratified by region and therapy naive/add-on therapy||Missing values for participants who withdrew/died before 12 weeks were imputed with worst value of 0m in case of death or clinical worsening without termination visit and with last observed value otherwise. Comparison was done using ANCOVA, with baseline 6MWD as a covariate and treatment group, region and treatment naive/add-on therapy as main effects. The primary statistical method was the stratified Wilcoxon test if the Shapiro-Wilk test for normality of residuals was statistically significant|
1711801|NCT00810615|3150479|Superiority or Other||Risk Ratio (RR)|1.0||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with four or more significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.|
1711802|NCT00810615|3150480|Superiority or Other||Risk Ratio (RR)|1.1111||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with three significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.|
1711803|NCT00810615|3150481|Superiority or Other||Risk Ratio (RR)|1.1||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with two significant events (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.|
1711804|NCT00810615|3150482|Superiority or Other||Risk Ratio (RR)|0.5455||||||||||||||Relative Risk of Improvement in 2.4 ATA group vs. Sham in subjects with one significant event (blast or impact resulting in concussion symptoms) per Concussion History. PCL-M with significant improvement defined as a score decrease 10 or more.|
1711805|NCT00810615|3150494|Superiority or Other|||||||0.05|||||||ANCOVA|A repeated measures model was designed so as to incorporate the adjust for the repeated (dependent) measures within individuals over time.||ANCOVA, baseline measurement was considered as a covariate and group (sham or 2.4 ATA), treatment (15 treatments, 30 treatments, and 6 weeks) as well as the interaction between group and treatment were considered as the independent variables.|
1711806|NCT00810602|3150497|Superiority or Other||Percent Cumulative Incidence of GVHD|16.0|||||2-Sided|95.0|8.0|30.0|||||||
1711807|NCT00810602|3150499|Superiority or Other||Percent Cumulative Incidence of GVHD|22.0|||||2-Sided|95.0|13.0|36.0||||||Hypothesis: The addition of vorinostat will reduce the incidence of grade 2-4 acute graft versus host disease (GVHD) to 25% or lower by day 100.|
1712194|NCT00807742|3151007|Superiority or Other||Odds Ratio (OR)|0.91||||0.772|2-Sided|95.0|0.49|1.7|||Chi-squared||||
1711809|NCT00810407|3150515|Superiority or Other|||||||0.587|||||||Fisher Exact|||"The factor tested was age. The null hypothesis was that there was no association between age of participants and the number of participants with treatment-related adverse events."|
1711810|NCT00810407|3150516|Superiority or Other||||||<|0.001|||||||Fisher Exact|||"The factor tested was gender. The null hypothesis was that there was no association between gender and the number of participants with treatment-related adverse events."|
1711811|NCT00810407|3150517|Superiority or Other||||||<|0.001|||||||Fisher Exact|||"The factor tested was diagnosis. The null hypothesis was that there was no association between diagnosis and the number of participants with treatment-related adverse events."|
1711812|NCT00810368|3150523|Superiority or Other|||||||0.5|||||||t-test, 2 sided||||
1711813|NCT00810368|3150524|Superiority or Other|||||||0.5|||||||t-test, 2 sided||||
1711814|NCT00810368|3150525|Superiority or Other|||||||0.5|||||||t-test, 2 sided||||
1711815|NCT00810368|3150527|Superiority or Other|||||||0.6|||||||t-test, 2 sided||||
1711816|NCT00810368|3150527|Superiority or Other|||||||0.0018|||||||t-test, 2 sided||||
1711817|NCT00810368|3150528|Superiority or Other|||||||0.018||||||Using Fisher's Exact Test, we determined whether there was a significant difference in the number of participants complaining of IBS symptoms.|Fisher Exact|2 by 2 Fisher's Exact Test|||
1711818|NCT00810368|3150529|Superiority or Other|||||||0.4|||||||t-test, 2 sided||||
1711819|NCT00810368|3150529|Superiority or Other|||||||0.3||||||2-tailed paired Student's t-tests between Week 0 and Week 12 responses (above) were anticipated to show significant benefits with carnosine treatment but no change with placebo. There were no corrections for multiple comparisons in the reported data.|t-test, 2 sided|Paired t-test||Description of Power Calculation: The planned sample size completing each arm was based on individual incremental improvements in the primary outcomes of : A) CFS Severity Scores (Baraniuk et al., Annals Allergy Astma Immunol, 1998), B) Instantaneous Fatigue (Kim et al. Journal of Rehab Res Dev, 2010), and C) increased accuracy of 4/35 letters for 2 back working memory task (Owen, Human Brain Mapping, 2005).|
1711820|NCT00810303|3150535|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.|
1711821|NCT00810303|3150535|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.|
1711822|NCT00810303|3150536|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.|
1711823|NCT00810303|3150537|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.|
1711824|NCT00810303|3150538|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.|
1711825|NCT00810303|3150538|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.|
1711826|NCT00810303|3150539|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe with single dose treatment of efavirenz.|
1711827|NCT00810303|3150539|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.|
1711828|NCT00810303|3150540|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe with chronic treatment of efavirenz and free ezetimibe alone.|
1711829|NCT00810303|3150540|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.|
1711830|NCT00810303|3150541|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetics of efavirenz with chronic treatment of ezetimibe.|
1711831|NCT00810303|3150541|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.|
1711832|NCT00810303|3150542|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetics of efavirenz with chronic treatment of ezetimibe.|
1711833|NCT00810303|3150543|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.|
1711834|NCT00810303|3150544|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz with chronic treatment of ezetimibe.|
1711835|NCT00810303|3150544|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.|
1711836|NCT00810303|3150545|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz with chronic treatment of ezetimibe.|
1711837|NCT00810303|3150546|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between steady state pharmakokinetic of efavirenz with chronic treatment of ezetimibe and the single dose pharmakokinetic of efavirenz without chronic treatment of ezetimibe.|
1711838|NCT00810303|3150548|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.|
1711882|NCT00810199|3150599|Superiority or Other|||||||0.224|||||||Wald Chi-square|Asymptotic test; parameter estimate is zero.||Week 52|
1711839|NCT00810303|3150549|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Paired Wilcoxon-test between free ezetimibe alone and free ezetimibe with single dose treatment of efavirenz.|
1711840|NCT00810264|3150574|Non-Inferiority|The primary safety endpoint 1 hypothesis was evaluated by performing an exact, non-inferiority test comparing a binomial proportion (overall SAEFR at 5 years) to 92.5%, with a non-inferiority delta of 5%.|||||<|0.0001|||||||Binomial Proportion||||
1711841|NCT00810199|3150576|Superiority or Other|||||||0.0734|||||||Log Rank||||
1711842|NCT00810199|3150577|Superiority or Other|||||||0.0096|||||||Log Rank||||
1711843|NCT00810199|3150578|Superiority or Other|||||||0.1695|||||||Log Rank||||
1711844|NCT00810199|3150579|Superiority or Other||Adjusted Mean Difference (Wald CI)|-2.11||||0.6027|2-Sided|95.0|-10.07|5.85|||ANCOVA|The analysis of covariance model included treatment group, region and baseline DAS28 (≤ 5.5 and > 5.5) as fixed factors.|||
1711845|NCT00810199|3150580|Superiority or Other||Adjusted Mean Difference (Wald CI)|5.22||||0.111|2-Sided|95.0|-1.2|11.64|||ANCOVA|The analysis of covariance model included treatment group, region and baseline DAS28 (≤ 5.5 and > 5.5) as fixed factors.|||
1711846|NCT00810199|3150582|Superiority or Other|||||||0.1671|||||||Wilcoxon (Mann-Whitney)||||
1711847|NCT00810199|3150582|Superiority or Other|||||||0.197|||||||Wilcoxon (Mann-Whitney)|||Week 52|
1711848|NCT00810199|3150582|Superiority or Other|||||||0.2652|||||||Wilcoxon (Mann-Whitney)|||Week 24|
1711849|NCT00810199|3150583|Superiority or Other||Difference|-1.48||||0.5188|2-Sided|95.0|-6.59|3.62|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and > 5.5).|||
1711850|NCT00810199|3150584|Superiority or Other||Difference|-2.91||||0.0496||95.0|-5.86|0.05|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and > 5.5).|||
1711851|NCT00810199|3150585|Superiority or Other|||||||0.1695|||||||Log Rank|||Week 104|
1711852|NCT00810199|3150585|Superiority or Other||Difference|6.75||||0.0694|2-Sided|95.0|-1.02|14.52|||Cochran-Mantel-Haenszel|Stratified by region and categorical baseline DAS28 (≤ 5.5 and > 5.5).||Week 52|
1711853|NCT00810199|3150586|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.0372|2-Sided|95.0|-0.56|-0.02||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104|
1711854|NCT00810199|3150586|Superiority or Other||Mean Difference (Final Values)|-0.33||||0.0012|2-Sided|95.0|-0.54|-0.13||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52|
1711855|NCT00810199|3150586|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.0441|2-Sided|95.0|-0.25|0.0||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24|
1711856|NCT00810199|3150587|Superiority or Other||Mean Difference (Final Values)|-0.32||||0.0778|2-Sided|95.0|-0.67|0.04||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104|
1711857|NCT00810199|3150587|Superiority or Other||Mean Difference (Final Values)|0.06||||0.8147|2-Sided|95.0|-0.45|0.57||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52|
1711858|NCT00810199|3150587|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.7095|2-Sided|95.0|-0.23|0.16||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24|
1711859|NCT00810199|3150588|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.0342|2-Sided|95.0|-1.16|-0.05||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 104|
1711860|NCT00810199|3150588|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.3611|2-Sided|95.0|-0.88|0.32||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 52|
1711861|NCT00810199|3150588|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.2034|2-Sided|95.0|-0.43|0.09||Baseline x-ray and DAS28 as covariates and treatment group and region as fixed effects.|ANCOVA|||Week 24|
1711862|NCT00810199|3150589|Superiority or Other|||||||0.1448|||||||Wilcoxon (Mann-Whitney)|||Week 52|
1711863|NCT00810199|3150589|Superiority or Other|||||||0.9323|||||||Wilcoxon (Mann-Whitney)|||Week 24|
1711864|NCT00810199|3150590|Superiority or Other|||||||0.681|||||||Wilcoxon (Mann-Whitney)|||Week 52|
1711865|NCT00810199|3150590|Superiority or Other|||||||0.6067|||||||Wilcoxon (Mann-Whitney)|||Week 24|
1711866|NCT00810199|3150591|Superiority or Other|||||||0.7706|||||||Wilcoxon (Mann-Whitney)|||Week 52|
1711867|NCT00810199|3150591|Superiority or Other|||||||0.5186|||||||Wilcoxon (Mann-Whitney)|||Week 24|
1711868|NCT00810199|3150592|Superiority or Other|||||||0.0308|||||||Wilcoxon (Mann-Whitney)|||Week 52|
1711869|NCT00810199|3150592|Superiority or Other|||||||0.9655|||||||Wilcoxon (Mann-Whitney)|||Week 24|
1711870|NCT00810199|3150593|Superiority or Other|||||||0.8841|||||||Wilcoxon (Mann-Whitney)|||Week 52|
1711871|NCT00810199|3150593|Superiority or Other|||||||0.2451||||||P-value is from a 2-sided, Wilcoxon rank-sum test of no difference between the 2 treatment groups in change from baseline.|Wilcoxon (Mann-Whitney)|||Week 24|
1711872|NCT00810199|3150594|Superiority or Other|||||||0.2931|||||||Wilcoxon (Mann-Whitney)|||Week 52|
1711873|NCT00810199|3150594|Superiority or Other|||||||0.3113|||||||Wilcoxon (Mann-Whitney)|||Week 24|
1711874|NCT00810199|3150595|Superiority or Other|||||||0.7179|||||||Wilcoxon (Mann-Whitney)|||Week 52|
1711875|NCT00810199|3150595|Superiority or Other|||||||0.9095|||||||Wilcoxon (Mann-Whitney)|||Week 24|
1711876|NCT00810199|3150596|Superiority or Other|||||||0.8843|||||||Wilcoxon (Mann-Whitney)|||Week 52|
1711877|NCT00810199|3150596|Superiority or Other|||||||0.7776||||||P-value is from a 2-sided, Wilcoxon rank-sum test of no difference between the 2 treatment groups in change from baseline.|Wilcoxon (Mann-Whitney)|||Week 24|
1711878|NCT00810199|3150597|Superiority or Other|||||||0.1181|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 52|
1711879|NCT00810199|3150597|Superiority or Other|||||||0.0019|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 24|
1711880|NCT00810199|3150598|Superiority or Other|||||||0.3918|||||||Wilcoxon (Mann-Whitney)|||Week 52|
1711881|NCT00810199|3150598|Superiority or Other|||||||0.0497|||||||Wilcoxon (Mann-Whitney)|||Week 24|
1711884|NCT00810199|3150600|Superiority or Other||Odds Ratio (OR)|1.482||||0.0258||95.0|1.048|2.095||Stratified by region and baseline DAS28 (≤ 5.5 and > 5.5).|Cochran-Mantel-Haenszel||||
1711885|NCT00810199|3150600|Superiority or Other||Odds Ratio (OR)|1.49||||0.0245|2-Sided|95.0|1.053|2.109|||Regression, Logistic|Logistic regression including treatment, region and baseline DAS28.|Odds ratio is for Tocilizumab + Methotrexate relative to Tocilizumab + Placebo.||
1711886|NCT00810199|3150601|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.0008|2-Sided|95.0|-0.41|-0.11|||ANCOVA|Baseline DAS28 as a covariate.|||
1711887|NCT00810199|3150602|Superiority or Other|||||||0.2217|||||||Log Rank||||
1711888|NCT00810199|3150603|Superiority or Other|||||||0.8526|||||||Log Rank||||
1711889|NCT00810199|3150604|Superiority or Other|||||||0.7176|||||||Log Rank||||
1711890|NCT00810199|3150605|Superiority or Other|||||||0.1018|||||||Log Rank||||
1711891|NCT00810199|3150606|Superiority or Other|||||||0.2546|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 104|
1711892|NCT00810199|3150606|Superiority or Other|||||||0.6528|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 52|
1711893|NCT00810199|3150606|Superiority or Other|||||||0.8369|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 24|
1711894|NCT00810199|3150607|Superiority or Other|||||||0.2168|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 104|
1711895|NCT00810199|3150607|Superiority or Other|||||||0.9976|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 52|
1711896|NCT00810199|3150607|Superiority or Other|||||||0.6775|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 24|
1711897|NCT00810199|3150608|Superiority or Other|||||||0.1243|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 104|
1711898|NCT00810199|3150608|Superiority or Other|||||||0.2215|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 52|
1711899|NCT00810199|3150608|Superiority or Other|||||||0.2969|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 24|
1711900|NCT00810199|3150609|Superiority or Other|||||||0.0963|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 104|
1711901|NCT00810199|3150609|Superiority or Other|||||||0.6212|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 52|
1711902|NCT00810199|3150609|Superiority or Other|||||||0.8742|||||||Cochran-Mantel-Haenszel|Region and baseline DAS28 (≤5.5 and >5.5) included as stratification variables.||Week 24|
1711903|NCT00810199|3150610|Superiority or Other||Odds Ratio (OR)|1.27||||0.1894|2-Sided|95.0|0.889|1.814||Logistic regression including treatment , region and baseline DAS28.|Regression, Logistic|Odds ratio is for Tocilizumab + Methotrexate relative to Tocilizumab + Placebo.|||
1711904|NCT00810199|3150610|Superiority or Other||Odds Ratio (OR)|1.26||||0.2055|2-Sided|95.0|0.882|1.799||Cochran-Mantel-Haenszel test stratified by region and baseline DAS28 (≤5.5 and >5.5).|Cochran-Mantel-Haenszel||||
1711905|NCT00810108|3150611|Non-Inferiority or Equivalence|The geometric mean and 90% confidence interval assessed whether the crushed and whole tablet administration AUCs were equivalent.|Ratio of Crushed/Whole Tablet AUC|0.55|||<|0.05|2-Sided|90.0|0.45|0.69|||t-test, 2 sided|||Lopinavir AUC was compared between whole tablet and crushed tablet administration by using a ratio of crushed/whole AUC.|
1711906|NCT00810069|3150624|Superiority or Other||Survival rate difference|-0.07||||0.116|2-Sided|95.0|-0.16|0.02||P-value is for comparison of early intervention versus delayed intervention as a function of survival rate over a 12 week period (Week 4 through Week 16).|Kaplan-Meier analysis|P-value for comparison of rates is based on normal approximation using Greenwood's estimation for standard error.||Survival function estimated over a 12 week period (Week 4 through Week 16): analysis of early intervention versus delayed intervention strategies|
1711907|NCT00810069|3150625|Superiority or Other|||||||0.075||||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan-Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies||Kaplan-Meier estimates (weeks): analysis of early intervention versus delayed intervention strategies|
1711908|NCT00810069|3150626|Superiority or Other||LS Mean|0.06|Standard Error of the Mean|0.81||0.937|2-Sided|95.0|-1.52|1.65||P-value for Week 16: Analysis for early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16|
1711909|NCT00810069|3150626|Superiority or Other||LS Mean|-0.68|Standard Error of the Mean|0.74||0.36|2-Sided|95.0|-2.13|0.78||P-value for Week 12: Analysis for early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12|
1711910|NCT00810069|3150626|Superiority or Other||LS Mean|-0.37|Standard Error of the Mean|0.7||0.597|2-Sided|95.0|-1.74|1.0||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8|
1711911|NCT00810069|3150627|Superiority or Other||LS Mean|0.01|Standard Error of the Mean|0.03||0.792|2-Sided|95.0|-0.05|0.06||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16|
1712027|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.|
1715136|NCT00772031|3156255|Superiority or Other||Odds Ratio (OR)|1.0||||||95.0|0.5|2.02|||||||
1711912|NCT00810069|3150627|Superiority or Other||LS Mean|-0.04|Standard Error of the Mean|0.02||0.071|2-Sided|95.0|-0.09|0.0||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12|
1711913|NCT00810069|3150627|Superiority or Other||LS Mean|-0.05|Standard Error of the Mean|0.02||0.021|2-Sided|95.0|-0.1|-0.01||P-value for Week 8: Analysis of early versus delayed intervention LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8|
1711914|NCT00810069|3150628|Superiority or Other||LS Mean|-0.04|Standard Error of the Mean|0.2||0.856|2-Sided|95.0|-0.43|0.36||P-value for Week 16: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16|
1711915|NCT00810069|3150628|Superiority or Other||LS Mean|0.09|Standard Error of the Mean|0.19||0.618|2-Sided|95.0|-0.27|0.46||P-value for Week 12: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12|
1711916|NCT00810069|3150628|Superiority or Other||LS Mean|0.14|Standard Error of the Mean|0.17||0.401|2-Sided|95.0|-0.19|0.47||P-value for Week 8: Analysis of early intervention versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8|
1711917|NCT00810069|3150629|Superiority or Other||LS Mean|-0.15|Standard Error of the Mean|0.23||0.51|2-Sided|95.0|-0.61|0.3||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline scores and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16|
1711918|NCT00810069|3150629|Superiority or Other||LS Mean|-0.19|Standard Error of the Mean|0.23||0.393|2-Sided|95.0|-0.63|0.25||P-value for Week 14: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 14|
1711919|NCT00810069|3150629|Superiority or Other||LS Mean|-0.29|Standard Error of the Mean|0.21||0.169|2-Sided|95.0|-0.71|0.12||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12|
1711920|NCT00810069|3150629|Superiority or Other||LS Mean|-0.15|Standard Error of the Mean|0.2||0.445|2-Sided|95.0|-0.55|0.24||P-value for Week 10: analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 10|
1711921|NCT00810069|3150629|Superiority or Other||LS Mean|-0.5|Standard Error of the Mean|0.19||0.01|2-Sided|95.0|-0.87|-0.12||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8|
1711922|NCT00810069|3150629|Superiority or Other||LS Mean|-0.62|Standard Error of the Mean|0.19||0.001|2-Sided|95.0|-0.98|-0.25||P-value for Week 6: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 6|
1711923|NCT00810069|3150630|Superiority or Other||LS Mean|0.0|Standard Error of the Mean|0.1||0.994|2-Sided|95.0|-0.2|0.2||P-value for Week 16: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 16|
1711924|NCT00810069|3150630|Superiority or Other||LS Mean|-0.13|Standard Error of the Mean|0.1||0.181|2-Sided|95.0|-0.33|0.06||P-value for Week 14: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 14|
1711925|NCT00810069|3150630|Superiority or Other||LS Mean|-0.16|Standard Error of the Mean|0.1||0.086|2-Sided|95.0|-0.35|0.02||P-value for Week 12: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interactions, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 12|
1711926|NCT00810069|3150630|Superiority or Other||LS Mean|-0.19|Standard Error of the Mean|0.09||0.044|2-Sided|95.0|-0.37|0.0||P-value for Week 10: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 10|
1712028|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.|
1711927|NCT00810069|3150630|Superiority or Other||LS Mean|-0.11|Standard Error of the Mean|0.09||0.208|2-Sided|95.0|-0.29|0.06||P-value for Week 8: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed Models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by-visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 8|
1711928|NCT00810069|3150630|Superiority or Other||LS Mean|-0.04|Standard Error of the Mean|0.09||0.624|2-Sided|95.0|-0.22|0.13||P-value for Week 6: Analysis of early versus delayed intervention strategies LS Mean/Estimate|Mixed Models Analysis|Mixed models repeated measures with fixed effects for strategy, country, visit, strategy-by-visit interaction, baseline score and baseline-by visit||Repeated Measurements Analysis: Early Intervention versus Delayed Intervention Strategy at Week 6|
1711929|NCT00810069|3150631|Superiority or Other|||||||0.597||||||P-value is for early intervention versus delayed intervention strategies.|Kaplan-Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies||Analysis of early intervention strategy versus delayed intervention strategy|
1711930|NCT00810069|3150632|Superiority or Other|||||||0.947||||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan Meier analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies.||Analysis of early intervention strategy versus delayed intervention strategy|
1711931|NCT00810069|3150633|Superiority or Other||survival rate difference|0.02||||0.653|2-Sided|95.0|-0.06|0.1||P-value is for comparison of early intervention versus delayed intervention as a function of survival rate over a 12 week period (Week 4 through Week 16).|Kaplan Meier analysis|P-value for comparison of rates is based on normal approximation using Greenwood's estimation for standard error.||Survival function estimated over a 12 week period (Week 4 through Week 16): analysis of early intervention versus delayed intervention strategies|
1711932|NCT00810069|3150634|Superiority or Other|||||||0.213||||||P-value is for early intervention strategy versus delayed intervention strategy.|Kaplan-Meier Analysis|Kaplan-Meier analysis with Wilcoxon test to compare strategies.||Kaplan-Meier Estimates (weeks): analysis of early intervention versus delayed intervention strategies|
1711933|NCT00810043|3150635|Superiority or Other|||||||0.36|||||||Chi-squared||||
1711934|NCT00810043|3150636|Superiority or Other|||||||0.144|||||||t-test, 2 sided||||
1711935|NCT00810043|3150637|Superiority or Other|||||||0.486|||||||t-test, 2 sided||||
1711936|NCT00810043|3150638|Superiority or Other|||||||0.889|||||||t-test, 2 sided||||
1711937|NCT00810043|3150639|Superiority or Other|||||||0.349|||||||t-test, 2 sided|||Posterior VBH gained by postural reduction|
1711938|NCT00810043|3150639|Superiority or Other|||||||0.62|||||||t-test, 2 sided|||Middle VBH gained by postural reduction|
1711939|NCT00810043|3150639|Superiority or Other|||||||0.9|||||||t-test, 2 sided|||Anterior VBH gained by postural reduction|
1711940|NCT00810043|3150641|Superiority or Other|||||||0.166|||||||t-test, 2 sided|||Posterior VBH restored|
1711941|NCT00810043|3150641|Superiority or Other|||||||0.578|||||||t-test, 2 sided|||Middle VBH restored|
1711942|NCT00810043|3150641|Superiority or Other|||||||0.402|||||||t-test, 2 sided|||Anterior VBH restored|
1711943|NCT00810043|3150642|Superiority or Other|||||||0.165|||||||t-test, 2 sided|||Posterior vertebral body height restoration as a percent (Post-procedure change from baseline)|
1711944|NCT00810043|3150642|Superiority or Other|||||||0.643|||||||t-test, 2 sided|||Middle vertebral body height restoration as a percent (Post-procedure change from baseline)|
1711945|NCT00810043|3150642|Superiority or Other|||||||0.43|||||||t-test, 2 sided|||Anterior vertebral body height restoration as a percent (Post-procedure change from baseline)|
1711946|NCT00809965|3150643|Superiority or Other||Hazard Ratio (HR)|0.88||||0.07|2-Sided|95.0|0.78|1.01|||Log Rank||Based upon the Cox proportional hazards model||
1711947|NCT00809965|3150643|Superiority or Other||Hazard Ratio (HR)|0.84||||0.011|2-Sided|95.0|0.73|0.96|||Log Rank||Based upon the Cox proportional hazards model||
1711948|NCT00809965|3150644|Superiority or Other||Hazard Ratio (HR)|0.89||||0.081|2-Sided|95.0|0.78|1.01|||Log Rank||Based upon the Cox proportional hazards model||
1711949|NCT00809965|3150644|Superiority or Other||Hazard Ratio (HR)|0.92||||0.185|2-Sided|95.0|0.8|1.04|||Log Rank||Based upon the Cox proportional hazards model||
1711950|NCT00809965|3150645|Superiority or Other||Hazard Ratio (HR)|0.95||||0.508|2-Sided|95.0|0.83|1.1|||Log Rank||Based upon the Cox proportional hazards model||
1711951|NCT00809965|3150645|Superiority or Other||Hazard Ratio (HR)|0.93||||0.32|2-Sided|95.0|0.81|1.07|||Log Rank||Based upon the Cox proportional hazards model||
1711952|NCT00809965|3150646|Superiority or Other||Hazard Ratio (HR)|0.84||||0.025|2-Sided|95.0|0.73|0.98|||Log Rank||Based on the Cox proportional hazards model||
1711953|NCT00809965|3150646|Superiority or Other||Hazard Ratio (HR)|0.83||||0.016|2-Sided|95.0|0.72|0.97|||Log Rank||Based on the Cox proportional hazards model||
1711954|NCT00809965|3150647|Superiority or Other||Hazard Ratio (HR)|0.85||||0.028|2-Sided|95.0|0.73|0.98|||Log Rank||Based upon the Cox proportional hazards model||
1711955|NCT00809965|3150647|Superiority or Other||Hazard Ratio (HR)|0.84||||0.02|2-Sided|95.0|0.72|0.97|||Log Rank||Based upon the Cox proportional hazards model||
1711956|NCT00809926|3150648|Superiority or Other||Least Square Mean Difference|-4.9||||0.006|2-Sided|95.0|-8.37|-1.42|||ANCOVA||||
1711957|NCT00809926|3150649|Superiority or Other||Least Square Mean Difference|-8.7||||0.004|2-Sided|95.0|-14.38|-2.93|||ANCOVA||||
1711958|NCT00809926|3150650|Superiority or Other||Least Square Mean Difference|-3.1||||0.04|2-Sided|95.0|-6.02|-0.14|||GENMOD|Based on a generalized estimating equations using SAS procedure GENMOD.|||
1711959|NCT00809926|3150651|Superiority or Other||Least Square Mean Difference|-3.4||||0.028|2-Sided|95.0|-6.34|-0.37|||ANCOVA||||
1711960|NCT00809926|3150654|Superiority or Other||Difference|11.6||||0.018|2-Sided|95.0|2.0|21.33|||Cochran-Mantel-Haenszel||||
1711961|NCT00809926|3150655|Superiority or Other||Difference|8.1||||0.101|2-Sided|95.0|-1.56|17.67|||Cochran-Mantel-Haenszel||||
1711962|NCT00809926|3150656|Superiority or Other||Least Square Mean Difference|-0.2||||0.79|2-Sided|95.0|-1.93|1.47|||ANCOVA||||
1711963|NCT00809926|3150657|Superiority or Other||Least Square Mean Difference|-1.6||||0.295|2-Sided|95.0|-4.61|1.4|||ANCOVA||||
1711964|NCT00809757|3150690|Superiority or Other||Mean Difference (Final Values)|-0.15|||||2-Sided|95.0|-1.08|0.771|||||Difference is Levalbuterol UDV minus Levalbuterol MDI|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.|
1711965|NCT00809757|3150690|Superiority or Other||Mean Difference (Final Values)|-0.69|||||2-Sided|95.0|-1.714|0.335|||||Difference is Levalbuterol UDV minus Levalbuterol MDI|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations|
1711966|NCT00809757|3150690|Superiority or Other||Mean Difference (Final Values)|-0.54|||||2-Sided|95.0|-1.412|0.342|||||Difference is Placebo MDI minus Levalbuterol UDV|195 subjects were randomized in order to achieve 150 subjects completing the study. The sample size was set based on FDA requirements, and was outside of statistical considerations.|
1711967|NCT00809523|3150706|Superiority or Other|||||||0.014|||||||t-test, 2 sided||||
1711968|NCT00809523|3150707|Superiority or Other|||||||0.007|||||||t-test, 2 sided|||Data were analyzed at the follow up timepoint (4 weeks) to test for differences between the experimental groups.|
1711969|NCT00809445|3150715|Superiority or Other||||||<|0.0001||||||a-priori threshold for statistical significance is .05|Chi-squared|chi-square = 428.2466, Df=2|||
1711970|NCT00809445|3150716|Superiority or Other|||||||0.044||||||a priori threshold for significance was .05|Chi-squared|Note that this is a 3 by 3 chi-square: the 3 conditions by discontinued sharing needles /no change in sharing needles/initiated sharing needles|||
1711971|NCT00809445|3150717|Superiority or Other||Incidence rate ratio (IRR)|1.03||||0.81|2-Sided|97.5|0.84|1.26||a-priori threshold for statistical significance is .025|Generalized estimating equations (GEE)||Numerator is the HIV rapid test and counseling arm Denominator is the HIV rapid test and info arm|"The data analysis information presented is for the comparison of the 2 on-site testing groups.~Hypothesis: HIV rapid test and counseling group will have fewer unprotected sexual acts than will HIV rapid test and info group"|
1711972|NCT00809445|3150717|Superiority or Other||incidence rate raios (IRR)|1.04||||0.39|2-Sided|97.5|0.95|1.14||a-priori threshold for statistical significance is .025|generalized estimating equations (GEE)||Numerator includes the two HIV rapid testing groups Denominator is the HIV testing referral group|Hypothesis: The HIV rapid testing arms would have a lower rate of unprotected sexual episodes than the HIV testing referral arm. Thus there is one comparison: HIV rapid test & counseling+HIV rapid test and info versus HIV testing referral.|
1711973|NCT00809445|3150718|Superiority or Other||Risk Ratio (RR)|4.52|||<|0.001|2-Sided|97.5|3.57|5.72||a-prior threshold for statistical significance is .025|Cochran-Mantel-Haenszel||The numerator is the two HIV rapid testing arms The denominator is the HIV testing referral arm|Hypothesis: The HIV rapid testing arms would have a higher rate of HIV testing than the HIV testing referral arm. Thus there is one comparison: HIV rapid test & counseling+HIV rapid test and info versus HIV testing referral.|
1711974|NCT00809146|3150754|Superiority or Other|||||||0.11|||||||t-test, 2 sided||||
1711975|NCT00809146|3150755|Superiority or Other|||||||0.09|||||||t-test, 2 sided||||
1711976|NCT00809146|3150757|Superiority or Other||Risk Ratio (RR)|1.99|||||2-Sided|95.0|0.3|10.7|||||||
1711977|NCT00809146|3150758|Superiority or Other||Risk Ratio (RR)|0.92|||||2-Sided|95.0|0.42|1.98|||||||
1711978|NCT00809146|3150759|Superiority or Other||Risk Ratio (RR)|1.08|||||2-Sided|95.0|0.74|1.56||||||All participants were included in this analysis of rate of recurrence because this is the most clinically relevant denominator, although, by definition, only participants who stopped could have recurrent seizures.|
1711979|NCT00809146|3150760|Superiority or Other||Risk Ratio (RR)|0.79|||||2-Sided|95.0|0.65|0.95|||||||
1711980|NCT00809146|3150761|Superiority or Other||Risk Ratio (RR)|0.88|||||2-Sided|95.0|0.79|0.98|||||||
1711981|NCT00809146|3150762|Superiority or Other||Risk Ratio (RR)|0.98|||||2-Sided|95.0|0.7|1.34|||||||
1711982|NCT00809146|3150763|Non-Inferiority or Equivalence|Assay sensitivity established by extensive review of lorazepam efficacy data. Noninferiority margin of 10% established by both clinical and statistical reasoning.|Risk Difference (RD)|0.1|||<|0.001|2-Sided|95.0|0.04|0.16|||one-sided z statistic|||The null hypothesis of inferiority was tested with a one-sided z statistic. Sample size was estimated assuming independent proportions, 2 interim analyses, 70% control event rate; 90% power; a noninferiority margin of 10%; and a 1-sided test with type I error probability of 0.025. A sample size of 890 (445 per treatment group) was inflated by 15% (1024 subjects) to account for inadvertent repeated enrollment of the same subjects. Repeated enrollments of the same subject were not analyzed.|
1711983|NCT00809094|3150794|Superiority or Other||Mean Difference (Net)|0.21||||0.14|2-Sided|95.0|-0.07|0.48|||t-test, 2 sided|||Null hypothesis: there will be no difference in the change in human neutrophil activity measured from baseline to end of the study (24 weeks)|
1711984|NCT00808665|3150816|Superiority|||||||0.36|||||||Wilcoxon (Mann-Whitney)||||
1711985|NCT00808639|3150819|Superiority or Other||Pathologic response rate|49.0|||||2-Sided|80.0|38.0|61.0||||||This study used a Simon’s optimal two-stage design. Of 39 eligible patients, if 18 achieved PaR, the treatment would be declared effective. A two-sided 80% CI was estimated considering the two-stage design based on Atkinson and Brown methods.|
1711986|NCT00808470|3150879|Superiority or Other|||||||0.24|||||||t-test, 2 sided|||1 week after exposure|
1711987|NCT00808470|3150879|Superiority or Other|||||||0.86|||||||t-test, 2 sided|||1 day after exposure|
1711988|NCT00808470|3150879|Superiority or Other|||||||0.36|||||||t-test, 2 sided|||3 hours, 15 minutes after exposure|
1711989|NCT00808470|3150879|Superiority or Other|||||||0.51|||||||t-test, 2 sided|||2 Hours 15 minutes after exposure|
1711990|NCT00808470|3150879|Superiority or Other|||||||0.39|||||||t-test, 2 sided|||1 hour and 15 minutes after exposure|
1711991|NCT00808470|3150879|Superiority or Other|||||||0.58|||||||t-test, 2 sided|||15 minutes after exposure|
1711992|NCT00808340|3150899|Non-Inferiority or Equivalence|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.2281|Standard Error of the Mean|0.2243|||2-Sided|97.5|-0.6767|0.2206|||||The mean difference is calculated as senofilcon A multifocal prod minus balafilcon A multifocal.|Alternativie hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.|
1712029|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.|
1711993|NCT00808340|3150899|Non-Inferiority or Equivalence|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.3304|Standard Error of the Mean|0.2243|||2-Sided|97.5|-0.779|0.1183|||||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hyposthesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.|
1711994|NCT00808340|3150900|Non-Inferiority or Equivalence|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.06765|Standard Error of the Mean|0.02656|||2-Sided|97.5|-0.1198|-0.01553|||||The mean difference is calculated as senfilcon A multifocal prod minus balafilcon A multifocal.|Alternative hypothesis is senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.|
1711995|NCT00808340|3150900|Non-Inferiority or Equivalence|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.02941|Standard Error of the Mean|0.02656|||2-Sided|97.5|-0.08153|0.02271|||||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.|
1711996|NCT00808340|3150901|Non-Inferiority or Equivalence|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.4608|Standard Error of the Mean|0.1464|||2-Sided|97.5|-0.7502|-0.1714|||||The mean difference was calculated as senofilcon A multifocal prod minus balafilcon A multifocal.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.|
1711997|NCT00808340|3150901|Non-Inferiority or Equivalence|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.04083|Standard Error of the Mean|0.1464|||2-Sided|97.5|-0.2485|0.3302|||||The mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.|
1711998|NCT00808340|3150902|Non-Inferiority or Equivalence|Non-inferiority margin = -0.5|Mean Difference (Final Values)|-0.3693|Standard Error of the Mean|0.1464|||2-Sided|97.5|-0.6587|-0.07996|||||The mean difference was calculated as balafilcon A multifocal minus senofilcon A multifocal prod.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to balafilcon A multifocal.|
1711999|NCT00808340|3150902|Non-Inferiority or Equivalence|Non-inferiority margin = -0.5.|Mean Difference (Final Values)|-0.1249|Standard Error of the Mean|0.1464|||2-Sided|97.5|-0.4143|0.1644|||||Mean difference is calculated as senofilcon A multifocal prod minus senofilcon A multifocal test.|Alternative hypothesis is that senofilcon A multifocal prod is non-inferior to senofilcon A multifocal test.|
1712000|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.|
1712001|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.|
1712002|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.|
1712003|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.|
1712004|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.|
1712005|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.|
1712006|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.|
1712007|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.|
1712008|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.|
1712009|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.|
1712010|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.|
1712011|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.|
1712012|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.|
1712013|NCT00808132|3150920|Superiority or Other||||||<|0.769|||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.|
1712014|NCT00808132|3150920|Superiority or Other||||||<|1|||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.|
1712015|NCT00808132|3150920|Superiority or Other||||||<|0.77|||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.|
1712016|NCT00808132|3150920|Superiority or Other||||||<|0.199|||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.|
1712017|NCT00808132|3150920|Superiority or Other||||||<|0.66|||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.|
1712018|NCT00808132|3150920|Superiority or Other||||||<|1|||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.|
1712019|NCT00808132|3150920|Superiority or Other||||||<|0.299|||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.|
1712020|NCT00808132|3150920|Superiority or Other||||||<|0.3|||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.|
1712021|NCT00808132|3150920|Superiority or Other||||||<|0.551|||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.|
1712022|NCT00808132|3150920|Superiority or Other||||||<|0.848|||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.|
1712023|NCT00808132|3150920|Superiority or Other||||||<|0.61|||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.|
1712024|NCT00808132|3150920|Superiority or Other||||||<|0.531|||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.|
1712025|NCT00808132|3150920|Superiority or Other||||||<|0.317|||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.|
1712026|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.|
1712030|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.|
1712031|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.|
1712032|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.|
1712033|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.|
1712034|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.|
1712035|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.|
1712036|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.|
1712037|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.|
1712038|NCT00808132|3150920|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.|
1712039|NCT00808132|3150920|Superiority or Other||||||<|1|||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.|
1712040|NCT00808132|3150920|Superiority or Other||||||<|0.226|||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.|
1712041|NCT00808132|3150920|Superiority or Other||||||<|1|||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.|
1712042|NCT00808132|3150920|Superiority or Other||||||<|0.014|||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.|
1712043|NCT00808132|3150920|Superiority or Other||||||<|0.065|||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.|
1712044|NCT00808132|3150920|Superiority or Other||||||<|1|||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.|
1712045|NCT00808132|3150920|Superiority or Other||||||<|0.285|||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.|
1712046|NCT00808132|3150920|Superiority or Other||||||<|0.689|||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.|
1712047|NCT00808132|3150920|Superiority or Other||||||<|0.307|||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.|
1712048|NCT00808132|3150920|Superiority or Other||||||<|0.425|||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.|
1712049|NCT00808132|3150920|Superiority or Other||||||<|0.087|||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.|
1712050|NCT00808132|3150920|Superiority or Other||||||<|0.868|||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.|
1712051|NCT00808132|3150920|Superiority or Other||||||<|0.624|||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.|
1712052|NCT00808132|3150921|Superiority or Other|||||||0.071|||||||ANCOVA|||Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712053|NCT00808132|3150921|Superiority or Other|||||||0.428|||||||ANCOVA|||Sexual function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712054|NCT00808132|3150921|Superiority or Other|||||||0.055|||||||ANCOVA|||Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712055|NCT00808132|3150921|Superiority or Other|||||||0.698|||||||ANCOVA|||Physical function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712056|NCT00808132|3150921|Superiority or Other|||||||0.493|||||||ANCOVA|||Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712057|NCT00808132|3150921|Superiority or Other|||||||0.68|||||||ANCOVA|||Psychosocial function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712058|NCT00808132|3150921|Superiority or Other||||||<|0.001|||||||ANCOVA|||Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712059|NCT00808132|3150921|Superiority or Other||||||<|0.001|||||||ANCOVA|||Vasomotor function: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712060|NCT00808132|3150923|Superiority or Other||LS Mean Difference|0.09||||0.477|2-Sided|95.0|-0.15|0.32|||ANCOVA|||Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712061|NCT00808132|3150923|Superiority or Other||LS Mean Difference|-0.07||||0.55|2-Sided|95.0|-0.32|0.17|||ANCOVA|||Sleep quantity: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712062|NCT00808132|3150923|Superiority or Other||LS Mean Difference|-2.48||||0.19|2-Sided|95.0|-6.2|1.23|||ANCOVA|||Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712063|NCT00808132|3150923|Superiority or Other||LS Mean Difference|-1.97||||0.308|2-Sided|95.0|-5.76|1.82|||ANCOVA|||Sleep problem index II: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712064|NCT00808132|3150923|Superiority or Other||LS Mean DIfference|-2.15||||0.254|2-Sided|95.0|-5.86|1.55|||ANCOVA|||Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712065|NCT00808132|3150923|Superiority or Other||LS Mean Difference|-1.35||||0.482|2-Sided|95.0|-5.12|2.42|||ANCOVA|||Sleep problem index I: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712066|NCT00808132|3150923|Superiority or Other||LS Mean Difference|2.84||||0.345|2-Sided|95.0|-3.07|8.75|||ANCOVA|||Sleep adequacy: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712067|NCT00808132|3150923|Superiority or Other||LS Mean Difference|2.76||||0.368|2-Sided|95.0|-3.26|8.78|||ANOVA|||Sleep adequacy: Month 3, ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712191|NCT00807742|3151004|Superiority||Odds Ratio (OR)|0.76||||0.49|2-Sided|95.0|0.36|1.65|||Chi-squared||||
1712068|NCT00808132|3150923|Superiority or Other||LS Mean DIfference|0.83||||0.665|2-Sided|95.0|-2.94|4.6|||ANCOVA|||Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712069|NCT00808132|3150923|Superiority or Other||LS Mean Difference|0.01||||0.996|2-Sided|95.0|-3.85|3.87|||ANCOVA|||Somnolence: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712070|NCT00808132|3150923|Superiority or Other||LS Mean Difference|-2.17||||0.218|2-Sided|95.0|-5.63|1.29|||ANCOVA|||ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712071|NCT00808132|3150923|Superiority or Other||LS Mean Difference|-0.63||||0.726|2-Sided|95.0|-4.15|2.9|||ANCOVA|||ASoB: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712072|NCT00808132|3150923|Superiority or Other||LS Mean Difference|-2.67||||0.247|2-Sided|95.0|-7.19|1.85|||ANOVA|||Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712073|NCT00808132|3150923|Superiority or Other||LS Mean Difference|-3.15||||0.18|2-Sided|95.0|-7.76|1.46|||ANCOVA|||Snoring: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712074|NCT00808132|3150923|Superiority or Other||LS Mean Difference|-3.84||||0.127|2-Sided|95.0|-8.78|1.1|||ANCOVA|||Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712075|NCT00808132|3150923|Superiority or Other||LS Mean Difference|-2.93||||0.253|2-Sided|95.0|-7.96|2.1|||ANCOVA|||Sleep disturbance: ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712076|NCT00808132|3150924|Superiority or Other|||||||0.791|||||||Cochran-Mantel-Haenszel|||Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712077|NCT00808132|3150924|Superiority or Other|||||||0.912|||||||Cochran-Mantel-Haenszel|||Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712078|NCT00808132|3150924|Superiority or Other|||||||0.892|||||||Cochran-Mantel-Haenszel|||Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712079|NCT00808132|3150924|Superiority or Other|||||||0.36|||||||Cochran-Mantel-Haenszel|||Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712080|NCT00808132|3150924|Superiority or Other|||||||0.23|||||||Cochran-Mantel-Haenszel|||Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712081|NCT00808132|3150924|Superiority or Other|||||||0.058|||||||Cochran-Mantel-Haenszel|||Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712082|NCT00808132|3150924|Superiority or Other|||||||0.258|||||||Cochran-Mantel-Haenszel|||Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712083|NCT00808132|3150924|Superiority or Other|||||||0.798|||||||Cochran-Mantel-Haenszel|||Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712084|NCT00808132|3150924|Superiority or Other|||||||0.906|||||||Cochran-Mantel-Haenszel|||Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712085|NCT00808132|3150924|Superiority or Other|||||||0.142|||||||Cochran-Mantel-Haenszel|||Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712086|NCT00808132|3150924|Superiority or Other|||||||0.1|||||||Cochran-Mantel-Haenszel|||Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712087|NCT00808132|3150924|Superiority or Other|||||||0.361|||||||Cochran-Mantel-Haenszel|||Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712088|NCT00808132|3150924|Superiority or Other|||||||0.641|||||||Cochran-Mantel-Haenszel|||Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712089|NCT00808132|3150924|Superiority or Other|||||||0.666|||||||Cochran-Mantel-Haenszel|||Week 49-52: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712090|NCT00808132|3150924|Superiority or Other|||||||0.644|||||||Cochran-Mantel-Haenszel|||Week 45-48: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712091|NCT00808132|3150924|Superiority or Other|||||||0.407|||||||Cochran-Mantel-Haenszel|||Week 41-44: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712092|NCT00808132|3150924|Superiority or Other|||||||0.391|||||||Cochran-Mantel-Haenszel|||Week 37-40: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712093|NCT00808132|3150924|Superiority or Other|||||||0.453|||||||Cochran-Mantel-Haenszel|||Week 33-36: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712094|NCT00808132|3150924|Superiority or Other|||||||0.03|||||||Cochran-Mantel-Haenszel|||Week 29-32: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712095|NCT00808132|3150924|Superiority or Other|||||||0.473|||||||Cochran-Mantel-Haenszel|||Week 25-28: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712096|NCT00808132|3150924|Superiority or Other|||||||0.81|||||||Cochran-Mantel-Haenszel|||Week 21-24: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712097|NCT00808132|3150924|Superiority or Other|||||||0.892|||||||Cochran-Mantel-Haenszel|||Week 17-20: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712098|NCT00808132|3150924|Superiority or Other|||||||0.446|||||||Cochran-Mantel-Haenszel|||Week 13-16: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712099|NCT00808132|3150924|Superiority or Other|||||||0.698|||||||Cochran-Mantel-Haenszel|||Week 9-12: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712100|NCT00808132|3150924|Superiority or Other|||||||0.821|||||||Cochran-Mantel-Haenszel|||Week 5-8: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712101|NCT00808132|3150924|Superiority or Other|||||||0.546|||||||Cochran-Mantel-Haenszel|||Week 1-4: Cochran-Mantel-Haenszel test was stratified by baseline value.|
1712102|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712103|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712104|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712105|NCT00808132|3150926|Superiority or Other||||||<|0.0016|||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712106|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712107|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712108|NCT00808132|3150926|Superiority or Other||||||<|0.0043|||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712109|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712110|NCT00808132|3150926|Superiority or Other||||||<|0.0046|||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712111|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||P1NP: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712112|NCT00808132|3150926|Superiority or Other||||||<|0.0029|||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712113|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||P1NP: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712114|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712115|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712116|NCT00808132|3150926|Superiority or Other||||||<|0.0012|||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712117|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712118|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712119|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712120|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712121|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712122|NCT00808132|3150926|Superiority or Other||||||<|0.0024|||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712123|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||C-Telopeptide: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712124|NCT00808132|3150926|Superiority or Other||||||<|0.1058|||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712125|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||C-Telopeptide: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712126|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712127|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712128|NCT00808132|3150926|Superiority or Other||||||<|0.0016|||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712129|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712130|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712131|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712132|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712133|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712134|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712135|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||Osteocalcin: Month 12, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712136|NCT00808132|3150926|Superiority or Other||||||<|0.0074|||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712137|NCT00808132|3150926|Superiority or Other||||||<|0.001|||||||ANCOVA|||Osteocalcin: Month 6, ANCOVA model was used with treatment and region as factors, and baseline as covariate.|
1712138|NCT00808132|3150927|Superiority or Other||LS Mean Difference|-0.13||||0.651|2-Sided|95.0|-0.696|0.436|||ANCOVA|||ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712139|NCT00808132|3150927|Superiority or Other||LS Mean Difference|-0.06||||0.832|2-Sided|95.0|-0.632|0.509|||ANCOVA|||ANCOVA model was used with treatment and region as factors and baseline as a covariate.|
1712140|NCT00808132|3150928|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1712141|NCT00808132|3150928|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1712142|NCT00808132|3150928|Superiority or Other||||||<|0.765|||||||Fisher Exact||||
1712143|NCT00808132|3150928|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1712144|NCT00808132|3150928|Superiority or Other||||||<|0.138|||||||Fisher Exact||||
1712145|NCT00808132|3150929|Superiority or Other||LS Mean Difference|1.6|||<|0.001|2-Sided|95.0|1.164|2.044|||ANCOVA|||Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.|
1712146|NCT00808132|3150929|Superiority or Other||LS Mean Difference|1.56|||<|0.001|2-Sided|95.0|1.152|1.962|||ANCOVA|||Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.|
1712147|NCT00808132|3150929|Superiority or Other||LS Mean Difference|1.21|||<|0.001|2-Sided|95.0|0.756|1.671|||ANCOVA|||Month 12: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.|
1712148|NCT00808132|3150929|Superiority or Other||LS Mean Difference|1.32|||<|0.001|2-Sided|95.0|0.901|1.742|||ANCOVA|||Month 6: ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.|
1712149|NCT00808132|3150930|Superiority or Other||LS Mean Difference|1.19|||<|0.001|2-Sided|95.0|0.556|1.83|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.|
1712150|NCT00808132|3150930|Superiority or Other||LS Mean Difference|0.8|||<|0.017|2-Sided|95.0|0.139|1.47|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.|
1712151|NCT00808132|3150931|Superiority or Other||LS Mean Difference|1.87|||<|0.001|2-Sided|95.0|1.209|2.533|||ANCOVA|||ANCOVA model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.|
1712152|NCT00808132|3150931|Superiority or Other||Least Squares (LS) Mean Difference|1.51|||<|0.001|2-Sided|95.0|0.822|2.201|||ANCOVA|||Analysis of covariance (ANCOVA) model was used with treatment and region as main effects and baseline BMD and years since menopause as covariates.|
1712153|NCT00808067|3150938|Superiority or Other||Hazard Ratio (HR)|0.93||||0.2241||95.0|0.82|1.05|||Regression, Cox||||
1712154|NCT00808067|3150939|Superiority or Other||Hazard Ratio (HR)|1.06||||0.5052|2-Sided|95.0|0.89|1.27|||Regression, Cox||||
1712155|NCT00808067|3150940|Superiority or Other||Hazard Ratio (HR)|1.1||||0.2371|2-Sided|95.0|0.94|1.29|||Regression, Cox||||
1712156|NCT00808067|3150941|Superiority or Other||Hazard Ratio (HR)|1.09||||0.5119|2-Sided|95.0|0.84|1.42|||Regression, Cox||||
1712157|NCT00808067|3150948|Superiority or Other||Hazard Ratio (HR)|0.77||||0.0055|2-Sided|95.0|0.64|0.93|||Regression, Cox||||
1712158|NCT00808028|3150953|Superiority or Other||||||<|0.0001|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712159|NCT00808028|3150953|Superiority or Other||||||<|0.0001|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712160|NCT00808028|3150953|Superiority or Other||||||<|0.0036|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712161|NCT00808028|3150953|Superiority or Other||||||>|0.9999|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712162|NCT00808028|3150953|Superiority or Other||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712163|NCT00808028|3150953|Superiority or Other||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712164|NCT00808028|3150953|Superiority or Other||||||<|0.0004|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712165|NCT00808028|3150953|Superiority or Other||||||>|0.9999|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712166|NCT00808028|3150954|Superiority or Other|||||||0.0244|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712167|NCT00808028|3150954|Superiority or Other|||||||0.0225|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712168|NCT00808028|3150954|Superiority or Other|||||||0.0392|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712169|NCT00808028|3150954|Superiority or Other||||||>|0.9999|||||||Binomial Distribution|||Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712192|NCT00807742|3151005|Superiority or Other||Odds Ratio (OR)|0.94||||0.812|2-Sided|95.0|0.54|1.62|||Chi-squared||||
1712193|NCT00807742|3151006|Superiority or Other||Odds Ratio (OR)|1.03||||0.91|2-Sided|95.0|0.6|1.77|||Chi-squared||||
1712170|NCT00808028|3150954|Superiority or Other||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712171|NCT00808028|3150954|Superiority or Other||||||<|0.0001|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712172|NCT00808028|3150954|Superiority or Other||||||<|0.0007|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712173|NCT00808028|3150954|Superiority or Other||||||>|0.9999|||||||Binomial Distribution|||Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.|
1712174|NCT00807846|3150980|Superiority or Other||Mean Difference (Final Values)|-0.102||||0.2|2-Sided|95.0|-0.257|0.053|||Chi-squared||Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.|The number of participants with at least a 30% improvement in participant's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.|
1712175|NCT00807846|3150981|Superiority or Other||Mean Difference (Final Values)|-0.402||||0.897|2-Sided|95.0|-6.5|5.69|||ANCOVA|||Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.|
1712176|NCT00807846|3150982|Superiority or Other||Mean Difference (Final Values)|-0.061||||0.392|2-Sided|95.0|-0.202|0.079|||Chi-squared||Mean Difference (Final Values) indicates difference in incidence (proportion) between treatments.|The number of subjects with at least a 30% improvement in Parent/Guardian's Global Assessment of Overall Well-Being was compared between the two treatment groups using a chi-square test. A 95% CI for the difference in incidence between groups was also computed.|
1712177|NCT00807846|3150983|Superiority or Other||Mean Difference (Final Values)|3.033||||0.303|2-Sided|95.0|-2.76|8.82|||ANCOVA|||Change from Baseline to Week 6 was analyzed using ANCOVA model as well with treatment and Baseline value as a covariate. The LS mean change from Baseline was compared between treatment groups and an appropriate p-value and 95% CI for the difference between the two treatment groups was generated. This analysis was conducted using a two-sided test with α=0.05.|
1712178|NCT00807846|3150984|Superiority or Other||Mean Difference (Final Values)|-0.179||||0.815|2-Sided|95.0|-1.69|1.33|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline blood pressure as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.|
1712179|NCT00807846|3150985|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.776|2-Sided|95.0|-1.3|1.74|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.|
1712180|NCT00807846|3150986|Superiority or Other||Mean Difference (Final Values)|-1.207||||0.106|2-Sided|95.0|-2.67|0.26|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.|
1712181|NCT00807846|3150987|Superiority or Other||Mean Difference (Final Values)|1.837||||0.027|2-Sided|95.0|0.21|3.46|||ANCOVA|||"For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in blood pressure was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates.~Secondary analyses were conducted using a two-sided test with α=0.05."|
1712182|NCT00807846|3150988|Superiority or Other||Mean Difference (Final Values)|1.088||||0.148|2-Sided|95.0|-0.39|2.57|||ANCOVA|||For secondary analyses, 95% CIs for the differences across treatment groups (celecoxib – naproxen) in the mean change from baseline were generated. The change from baseline in BP was analyzed using an ANCOVA model with terms for treatment, baseline height, weight, age and baseline BP as covariates. Secondary analyses were conducted using a two-sided test with α=0.05.|
1712183|NCT00807846|3150989|Superiority or Other||Mean Difference (Final Values)|1.1||||0.274|2-Sided|90.0|-0.56|2.76|||ANCOVA|||The primary analysis was based on 90% confidence interval (CI) for the difference across treatment groups (celecoxib – naproxen) in mean change from baseline in SBP. Change from Baseline in BP was analyzed using analysis of covariance (ANCOVA) with model terms for treatment with baseline height, baseline weight, baseline age, and baseline SBP as covariates. No formal hypothesis testing was applied to the primary analysis.|
1712184|NCT00807742|3150997|Superiority or Other||Effect Size d|-0.17||||0.199|2-Sided|95.0|-0.42|0.09|||t-test, 2 sided||||
1712185|NCT00807742|3150998|Superiority or Other||Effect Size d|-0.16||||0.202|2-Sided|95.0|-0.4|0.08|||t-test, 2 sided||||
1712186|NCT00807742|3150999|Superiority or Other||Effect Size d|-0.25||||0.069|2-Sided|95.0|-0.46|0.02|||t-test, 2 sided||||
1712187|NCT00807742|3151000|Superiority or Other||Effect Size d|-0.37||||0.001|2-Sided|95.0|-0.59|-0.15|||t-test, 2 sided||||
1712188|NCT00807742|3151001|Superiority||Odds Ratio (OR)|0.96||||0.876|2-Sided|95.0|0.58|1.6|||Chi-squared||||
1712189|NCT00807742|3151002|Superiority||Odds Ratio (OR)|1.19||||0.499|2-Sided|95.0|0.72|1.97|||Chi-squared||||
1712190|NCT00807742|3151003|Superiority||Odds Ratio (OR)|1.19||||0.511|2-Sided|95.0|0.67|2.06|||Chi-squared||||
1712195|NCT00807742|3151008|Superiority or Other||Odds Ratio (OR)|1.48||||0.402|2-Sided|95.0|0.59|3.72|||Chi-squared||||
1712196|NCT00807742|3151009|Superiority||Effect Size d|-0.15||||0.249|2-Sided|95.0|-0.4|0.11|||t-test, 2 sided||||
1712197|NCT00807742|3151010|Superiority||Effect Size d|-0.12||||0.148|2-Sided|95.0|-0.57|0.33|||t-test, 2 sided||||
1712198|NCT00807742|3151011|Superiority||Effect Size d|-0.15||||0.199|2-Sided|95.0|-0.38|0.08|||t-test, 2 sided||||
1712199|NCT00807742|3151012|Superiority||Effect Size d|-0.49|||<|0.001|2-Sided|95.0|-0.71|-0.27|||t-test, 2 sided||||
1712200|NCT00807742|3151013|Superiority or Other||Odds Ratio (OR)|2.08||||0.298|2-Sided|95.0|0.51|8.45|||Chi-squared||||
1712201|NCT00807742|3151014|Superiority or Other||Odds Ratio (OR)|2.03||||0.32|2-Sided|95.0|0.49|8.23|||Chi-squared||||
1712202|NCT00807742|3151015|Superiority or Other||Odds Ratio (OR)|1.81||||0.29|2-Sided|95.0|0.57|2.63|||Chi-squared||||
1712203|NCT00807742|3151016|Superiority or Other||Odds Ratio (OR)|1.22||||0.606|2-Sided|95.0|0.57|2.63|||Chi-squared||||
1712204|NCT00807248|3151053|Superiority or Other||Mean Difference (Final Values)|-0.71|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-0.97|-0.45|||ANCOVA||||
1712205|NCT00807248|3151053|Superiority or Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-0.88|-0.36|||ANCOVA||||
1712206|NCT00807248|3151053|Superiority or Other||Mean Difference (Final Values)|-0.76|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|-1.02|-0.5|||ANCOVA||||
1712207|NCT00807248|3151054|Superiority or Other||Mean Difference (Final Values)|-0.72|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-0.99|-0.44|||ANCOVA||||
1712208|NCT00807248|3151054|Superiority or Other||Mean Difference (Final Values)|-0.54|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-0.82|-0.26|||ANCOVA||||
1712209|NCT00807248|3151054|Superiority or Other||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-0.89|-0.34|||ANCOVA||||
1712210|NCT00807248|3151055|Superiority or Other||Mean Difference (Final Values)|-1.38|Standard Error of the Mean|0.32|<|0.0001|2-Sided|95.0|-2.0|-0.76|||ANCOVA||||
1712211|NCT00807248|3151055|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.32|<|0.0006|2-Sided|95.0|-1.72|-0.48|||ANCOVA||||
1712212|NCT00807248|3151055|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.31|<|0.0002|2-Sided|95.0|-1.82|-0.58|||ANCOVA||||
1712213|NCT00807248|3151056|Superiority or Other||Mean Difference (Final Values)|-1.29|Standard Error of the Mean|0.32|<|0.0001|2-Sided|95.0|-1.92|-0.66|||ANCOVA||||
1712214|NCT00807248|3151056|Superiority or Other||Mean Difference (Final Values)|-1.05|Standard Error of the Mean|0.33|<|0.0013|2-Sided|95.0|-1.69|-0.41|||ANCOVA||||
1712215|NCT00807248|3151056|Superiority or Other||Mean Difference (Final Values)|-1.09|Standard Error of the Mean|0.32|<|0.0007|2-Sided|95.0|-1.72|-0.46|||ANCOVA||||
1712216|NCT00807248|3151057|Superiority or Other||Mean Difference (Final Values)|-1.26|Standard Error of the Mean|0.31|<|0.0001|2-Sided|95.0|-1.87|-0.65|||ANCOVA||||
1712217|NCT00807248|3151057|Superiority or Other||Mean Difference (Final Values)|-1.11|Standard Error of the Mean|0.31|<|0.0004|2-Sided|95.0|-1.72|-0.5|||ANCOVA||||
1712218|NCT00807248|3151057|Superiority or Other||Mean Difference (Final Values)|-1.25|Standard Error of the Mean|0.31|<|0.0001|2-Sided|95.0|-1.85|-0.64|||ANCOVA||||
1712219|NCT00807248|3151058|Superiority or Other||Mean Difference (Final Values)|-3.61|Standard Error of the Mean|0.77|<|0.0001|2-Sided|95.0|-5.13|-2.1|||ANCOVA||||
1712220|NCT00807248|3151058|Superiority or Other||Mean Difference (Final Values)|-2.64|Standard Error of the Mean|0.77|<|0.0006|2-Sided|95.0|-4.15|-1.14|||ANCOVA||||
1712221|NCT00807248|3151058|Superiority or Other||Mean Difference (Final Values)|-3.09|Standard Error of the Mean|0.77|<|0.0001|2-Sided|95.0|-4.59|-1.58|||ANCOVA||||
1712222|NCT00807248|3151059|Superiority or Other||Mean Difference (Final Values)|-5.27|Standard Error of the Mean|1.09|<|0.0001|2-Sided|95.0|-7.41|-3.13|||ANCOVA||||
1712223|NCT00807248|3151059|Superiority or Other||Mean Difference (Final Values)|-4.46|Standard Error of the Mean|1.09|<|0.0001|2-Sided|95.0|-6.6|-2.32|||ANCOVA||||
1712224|NCT00807248|3151059|Superiority or Other||Mean Difference (Final Values)|-4.98|Standard Error of the Mean|1.09|<|0.0001|2-Sided|95.0|-7.13|-2.84|||ANCOVA||||
1712225|NCT00807248|3151060|Superiority or Other||Mean Difference (Final Values)|-6.0|Standard Error of the Mean|1.24|<|0.0001|2-Sided|95.0|-8.43|-3.56|||ANCOVA||||
1712226|NCT00807248|3151060|Superiority or Other||Mean Difference (Final Values)|-5.09|Standard Error of the Mean|1.24|<|0.0001|2-Sided|95.0|-7.53|-2.66|||ANCOVA||||
1712227|NCT00807248|3151060|Superiority or Other||Mean Difference (Final Values)|-5.55|Standard Error of the Mean|1.24|<|0.0001|2-Sided|95.0|-7.98|-3.11|||ANCOVA||||
1712228|NCT00807248|3151061|Superiority or Other||Mean Difference (Final Values)|0.47|Standard Error of the Mean|0.96||0.6227|2-Sided|95.0|-1.41|2.35|||ANCOVA||||
1712229|NCT00807248|3151061|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.96||0.6405|2-Sided|95.0|-2.34|1.44|||ANCOVA||||
1712230|NCT00807092|3151077|Superiority or Other||Mean Difference (Net)|-0.012|Standard Error of the Mean|0.038||0.7544||95.0|-0.088|0.064||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate|Blood glucose below 2.5 mmol/l|"The null hypothesis (H0) was:~H0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment–Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment–Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours"|
1712231|NCT00807092|3151077|Superiority or Other||Mean Difference (Net)|-0.054|Standard Error of the Mean|0.128||0.671||95.0|-0.307|0.198||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of duration of hypoglycaemic events as covariate|Blood glucose below 3.5 mmol/l|"The null hypothesis (H0) was:~H0: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment–Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment =0 hours against the alternative hypothesis(H1): H1: Duration of Hypoglycaemic Events Based on CGMS of BIAsp 30 after 6 weeks of treatment–Duration of Hypoglycaemic Events Based on CGMS of BHI 30 after 6 weeks of treatment≠0 hours"|
1712232|NCT00807092|3151078|Superiority or Other||Mean Difference (Net)|0.02|Standard Error of the Mean|0.113||0.8598||95.0|-0.243|0.243||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of HbA1c as covariate||"The null hypothesis (H0) was:~H0: Change in HbA1c of BIAsp 30 after 6 weeks of treatment–Change in HbA1c of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in HbA1c of BIAsp 30 after 6 weeks of treatment–Change in HbA1c of BHI 30 after 6 weeks of treatment≠0%"|
1712233|NCT00807092|3151079|Superiority or Other||Mean Difference (Net)|0.328|Standard Error of the Mean|0.577||0.5706||95.0|-0.813|1.468||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of GA as covariate||"The null hypothesis (H0) was:~H0: Change in GA of BIAsp 30 after 6 weeks of treatment–Change in GA of BHI 30 after 6 weeks of treatment =0 % against the alternative hypothesis(H1): H1: Change in GA of BIAsp 30 after 6 weeks of treatment–Change in GA of BHI 30 after 6 weeks of treatment≠0 %"|
1712234|NCT00807092|3151080|Superiority or Other||Mean Difference (Net)|0.187|Standard Error of the Mean|0.371||0.6149||95.0|-0.547|0.921||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (visit 2) value of mean MAGE as covariate||The full analysis set using LOCF (Last Observation Carried Forward) consists of all randomised subjects who had been exposed to at least one dose of the trial products.|
1712235|NCT00807092|3151081|Superiority or Other||Mean Difference (Net)|0.29||||0.313||95.0|-0.28|0.85||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Average|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment–Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment–Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712236|NCT00807092|3151081|Superiority or Other||Mean Difference (Net)|-0.05||||0.922||95.0|-1.16|1.05||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Dinner|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment–Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment–Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712237|NCT00807092|3151081|Superiority or Other||Mean Difference (Net)|0.05||||0.933||95.0|-1.12|1.22||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Lunch|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment–Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment–Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712238|NCT00807092|3151081|Superiority or Other||Mean Difference (Net)|0.99||||0.062||95.0|-0.05|2.04||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of prandial BG increment as covariate|Breakfast|"For each endpoint of Prandial Blood Glucose Increment :The null hypothesis (H0) was:~H0: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment–Change in prandial BG increment of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in prandial BG increment of BIAsp 30 after 6 weeks of treatment–Change in prandial BG increment of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712239|NCT00807092|3151082|Superiority or Other||Mean Difference (Net)|0.27||||0.274||95.0|-0.22|0.75||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Average|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712240|NCT00807092|3151082|Superiority or Other||Mean Difference (Net)|0.77||||0.008||95.0|0.21|1.33||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|3 AM|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712241|NCT00807092|3151082|Superiority or Other||Mean Difference (Net)|0.19||||0.643||95.0|-0.61|0.99||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Bedtime|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712242|NCT00807092|3151082|Superiority or Other||Mean Difference (Net)|-0.47||||0.326||95.0|-1.42|0.48||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after dinner|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712243|NCT00807092|3151082|Superiority or Other||Mean Difference (Net)|-0.27||||0.581||95.0|-1.23|0.69||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Before dinner|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712256|NCT00807014|3151100|Superiority or Other||||||<|0.001||||||Analysis of covariance (ANCOVA) model was used with terms for baseline value, treatment, and center. Treatment-by-center interaction was not included.|ANCOVA||||
1712257|NCT00806988|3151103|Other|||||||0.83|||||||Chi-squared||||
1712244|NCT00807092|3151082|Superiority or Other||Mean Difference (Net)|0.17||||0.747||95.0|-0.86|1.19||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after lunch|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712245|NCT00807092|3151082|Superiority or Other||Mean Difference (Net)|0.27||||0.5||95.0|-0.53|1.08||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|Before lunch|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712246|NCT00807092|3151082|Superiority or Other||Mean Difference (Net)|1.23||||0.026||95.0|0.15|2.31||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of BG as covariate|2 hours after breakfast|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712247|NCT00807092|3151082|Superiority or Other||Mean Difference (Net)|0.11||||0.676||95.0|-0.41|0.63||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 2) value of BG as covariate|Before breakfast|"For each endpoint of SMBG :The null hypothesis (H0) was:~H0: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in BG of BIAsp 30 after 6 weeks of treatment–Change in BG of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712248|NCT00807092|3151083|Superiority or Other||Mean Difference (Net)|0.495|Standard Error of the Mean|0.247||0.0472||95.0|0.006|0.984||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate||"The null hypothesis (H0) was:~H0: Change in FPG of BIAsp 30 after 6 weeks of treatment–Change in FPG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in FPG of BIAsp 30 after 6 weeks of treatment–Change in FPG of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712249|NCT00807092|3151085|Superiority or Other||Mean Difference (Net)|0.448|Standard Error of the Mean|0.261||0.0891||95.0|-0.069|0.964||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; baseline (week 0) value of mean FBG as covariate||"The null hypothesis (H0) was:~H0: Change in mean FBG of BIAsp 30 after 6 weeks of treatment–Change in mean FBG of BHI 30 after 6 weeks of treatment =0 mmol/L against the alternative hypothesis(H1): H1: Change in mean FBG of BIAsp 30 after 6 weeks of treatment–Change in mean FBG of BHI 30 after 6 weeks of treatment≠0 mmol/L"|
1712250|NCT00807092|3151086|Superiority or Other||Mean Difference (Net)|-0.749||||0.3093||95.0|-2.2|0.703||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Dinner|"Null hypothesis and alternative hypothesis for dinner:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for dinner after 6 weeks of treatment–Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment =0 mol*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for dinner after 6 weeks of treatment–Change in mean IAUC(0-4h) of BHI 30 for dinner after 6 weeks of treatment≠0 mol*h/L"|
1712251|NCT00807092|3151086|Superiority or Other||Mean Difference (Net)|-0.318|Standard Error of the Mean|1.216||0.794||95.0|-2.724|2.087||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Lunch|"Null hypothesis and alternative hypothesis for lunch:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for lunch after 6 weeks of treatment–Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment =0 mol*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for lunch after 6 weeks of treatment–Change in mean IAUC(0-4h) of BHI 30 for lunch after 6 weeks of treatment≠0 mol*h/L"|
1712252|NCT00807092|3151086|Superiority or Other||Mean Difference (Net)|1.178|Standard Error of the Mean|1.0||0.2412||95.0|-0.802|3.157||A statistical significant threshold p<0.05|ANCOVA|Treatment and strata as factors; corresponding baseline (week 0) value of mean IAUC(0-4h) as covariate (breakfast/lunch/dinner)|Breakfast|"Null hypothesis and alternative hypothesis for breakfast:~The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment–Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment =0 mol*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4h) of BIAsp 30 for breakfast after 6 weeks of treatment–Change in mean IAUC(0-4h) of BHI 30 for breakfast after 6 weeks of treatment≠0 mol*h/L"|
1712253|NCT00807092|3151087|Superiority or Other||Mean Difference (Net)|-0.013|Standard Error of the Mean|0.666||||95.0|-1.332|1.306|||||BIAsp 30 – BHI 30|"The null hypothesis (H0) was:~H0: Change in mean IAUC(0-4hours) of BIAsp 30 after 6 weeks of treatment–Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment greater than or equal to 0 mol*h/L against the alternative hypothesis(H1): H1: Change in mean IAUC (0-4hours) of BIAsp 30 after 6 weeks of treatment–Change in mean IAUC(0-4hours) of BHI 30 after 6 weeks of treatment less than 0 mol*h/L"|
1712254|NCT00807040|3151088|Other|We used the log-rank test to compare rates of death from baseline to 2 years.|Hazard Ratio (HR)|0.79||||0.39|2-Sided|95.0|0.46|1.35|||Log Rank||||
1712255|NCT00807040|3151089|Other|We tested this hypothesis in an intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level. This analysis accommodated nonignorable missing LVESVI outcomes owing to the death of patients by assigning deceased patients the worst ranks in order on the basis of the time of death. We used multiple imputation for data that were missing for reasons other than death to calculate the 12-month LVESVI on the assumption that the data were missing at random.||||||0.18|||||||Wilcoxon (Mann-Whitney)|||The trial was designed with a power of 90% to detect a between-group difference of 15 ml per square meter in the LVESVI from baseline to 12 months. We assumed a baseline LVESVI of 100 ml per square meter, improvements of 20 ml per square meter in the repair group and 35 ml per square meter in the replacement group, and equal 1-year mortality of 10 to 20% in the two groups. The primary null hypothesis was that there would be no between-group difference in the LVESVI at 12 months.|
1712258|NCT00806988|3151104|Other|An intention-to-treat analysis using a two-tailed Wilcoxon rank-sum test, at a 0.05 alpha level was used. This analysis accommodated missing LVESVI outcomes owing to death by assigning deceased patients the worst ranks in order according to the time of death. In the case of data that were missing for reasons other than death, we used multiple imputation to calculate the 12-month LVESVI on the assumption that the data were missing at random.||||||0.61|||||||Wilcoxon (Mann-Whitney)|||The primary null hypothesis was that there would be no significant between-group difference in the LVESVI at 12 months.|
1712259|NCT00806819|3151107|Superiority or Other||Hazard Ratio (HR)|1.01||||0.8929|2-Sided|95.0|0.84|1.23|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of pain. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs >= 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).|
1712260|NCT00806819|3151107|Superiority or Other||Hazard Ratio (HR)|0.93||||0.4264|2-Sided|95.0|0.77|1.12|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of dyspnoea. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs >=1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).|
1712261|NCT00806819|3151107|Superiority or Other||Hazard Ratio (HR)|0.83||||0.1181|2-Sided|95.0|0.66|1.05|||Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of cough. HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs >=1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|
1712262|NCT00806819|3151108|Superiority or Other||Hazard Ratio (HR)|0.93||||0.5068|2-Sided|95.0|0.74|1.16|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).|
1712263|NCT00806819|3151109|Superiority or Other|||||||0.0565||||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the investigator's assessment|
1712264|NCT00806819|3151109|Superiority or Other|||||||0.1558||||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the central independent review|
1712265|NCT00806819|3151111|Superiority or Other||Odds Ratio (OR)|1.29||||0.1071|2-Sided|95.0|0.95|1.75||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio >1 indicates a benefit to nintedanib|Analysis based on investigator's assessment|
1712266|NCT00806819|3151111|Superiority or Other||Odds Ratio (OR)|1.37||||0.0387|2-Sided|95.0|1.02|1.85||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio >1 indicates a benefit to nintedanib|Analysis based on the central independent review|
1712267|NCT00806819|3151114|Superiority or Other||Odds Ratio (OR)|1.15||||0.518|2-Sided|95.0|0.75|1.76||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio >1 indicates a benefit to nintedanib|Analysis based on the investigator's assessment|
1712268|NCT00806819|3151114|Superiority or Other||Odds Ratio (OR)|1.1||||0.7279|2-Sided|95.0|0.65|1.85||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio >1 indicates a benefit to nintedanib|Analysis based on the central independent review|
1712269|NCT00806819|3151115|Superiority or Other||Hazard Ratio (HR)|0.86||||0.0865|2-Sided|95.0|0.73|1.02|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|
1712270|NCT00806819|3151116|Superiority or Other||Hazard Ratio (HR)|0.84||||0.0506|2-Sided|95.0|0.7|1.0|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|
1712271|NCT00806819|3151117|Superiority or Other||Hazard Ratio (HR)|1.01||||0.894|2-Sided|95.0|0.85|1.21|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).|
1712272|NCT00806819|3151118|Superiority or Other||Hazard Ratio (HR)|0.83||||0.0435|2-Sided|95.0|0.7|0.99|||Regression, Cox||HR below 1 favors nintedanib|HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no).|
1712273|NCT00806624|3151130|Superiority or Other||difference in percentage|-5.6|||||2-Sided|95.0|-19.3|8.2|||||||
1712274|NCT00806624|3151130|Superiority or Other||difference in percentages|-9.1|||||2-Sided|95.0|-22.4|4.5|||||||
1712275|NCT00806624|3151130|Superiority or Other||difference in percentages|-3.5|||||2-Sided|95.0|-16.2|9.4|||||||
1712276|NCT00806585|3151132|Superiority or Other||Difference in least squares means|-0.32||||0.045|2-Sided|95.0|-0.63|-0.01|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712277|NCT00806585|3151132|Superiority or Other||Difference in least squares means|-0.22||||0.095|2-Sided|95.0|-0.48|0.04|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712318|NCT00806260|3151194|Non-Inferiority or Equivalence|non inferiority|Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.04|||2-Sided|95.0|-0.13|0.05||||||at 6 hr timepoint|
1712278|NCT00806585|3151132|Superiority or Other||Difference in least sqaures means|-0.28||||0.035|2-Sided|95.0|-0.54|-0.02|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712279|NCT00806585|3151132|Superiority or Other||Difference in least squares means|-0.18||||0.152|2-Sided|95.0|-0.44|0.07|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712280|NCT00806585|3151133|Superiority or Other||Difference in least squares means|-2.2||||0.008|2-Sided|95.0|-3.7|-0.6|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712281|NCT00806585|3151133|Superiority or Other||Diffference in least squares means|-1.3||||0.066|2-Sided|95.0|-2.6|0.1|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712282|NCT00806585|3151133|Superiority or Other||Difference in least squares means|-2.0||||0.004|2-Sided|95.0|-3.3|-0.6|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712283|NCT00806585|3151133|Superiority or Other||Difference in least squares means|-1.9||||0.006|2-Sided|95.0|-3.2|-0.5|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712284|NCT00806585|3151134|Superiority or Other||Difference in least squares means|0.8||||0.854|2-Sided|95.0|-7.6|9.2|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect|||
1712285|NCT00806585|3151134|Superiority or Other||Difference in least squares means|-0.9||||0.793|2-Sided|95.0|-7.6|5.8|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect|||
1712286|NCT00806585|3151134|Superiority or Other||Difference in least squares means|1.8||||0.597|2-Sided|95.0|-5.0|8.7|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect|||
1712287|NCT00806585|3151134|Superiority or Other||Difference in least squares means|-1.4||||0.684|2-Sided|95.0|-8.3|5.5|||ANCOVA|Fixed effects for treatment baseline, stratification, time, interaction of time by stratification and treatments factors and a random subject effect|||
1712288|NCT00806585|3151135|Superiority or Other||Difference in least squares means|6.7|||<|0.001|2-Sided|95.0|3.0|10.4|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712289|NCT00806585|3151135|Superiority or Other||Difference in least squares means|5.2|||<|0.006|2-Sided|95.0|1.5|8.9|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712290|NCT00806585|3151135|Superiority or Other||Difference in least squares means|6.1|||<|0.001|2-Sided|95.0|2.4|9.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712291|NCT00806585|3151135|Superiority or Other||Difference in least squares means|-7.0|||<|0.001|2-Sided|95.0|-10.7|-3.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712292|NCT00806585|3151135|Superiority or Other||Difference in least squares means|-0.4|||<|0.821|2-Sided|95.0|-3.5|2.7|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712293|NCT00806585|3151135|Superiority or Other||Difference in least squares means|-1.8|||<|0.246|2-Sided|95.0|-4.9|1.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712294|NCT00806585|3151135|Superiority or Other||Difference in least squares means|-0.9|||<|0.543|2-Sided|95.0|-4.0|2.1|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712295|NCT00806585|3151136|Superiority or Other||Difference in least squares means|1.9||||0.108|2-Sided|95.0|-0.4|4.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712296|NCT00806585|3151136|Superiority or Other||Difference in least squares means|2.0||||0.088|2-Sided|95.0|-0.3|4.4|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712297|NCT00806585|3151136|Superiority or Other||Difference in least squares means|1.0||||0.393|2-Sided|95.0|-1.3|3.3|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712298|NCT00806585|3151136|Superiority or Other||Difference in least squares means|-2.1||||0.074|2-Sided|95.0|-4.5|0.2|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712299|NCT00806585|3151136|Superiority or Other||Difference in least squares means|-0.2||||0.829|2-Sided|95.0|-2.2|1.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712319|NCT00806260|3151194|Non-Inferiority or Equivalence|non inferiority|Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.03|||2-Sided|95.0|-0.08|0.06||||||at 2 hr timepoint|
1712300|NCT00806585|3151136|Superiority or Other||Difference in least squares means|-0.1||||0.919|2-Sided|95.0|-2.1|1.9|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712301|NCT00806585|3151136|Superiority or Other||Difference in least squares means|-1.1||||0.253|2-Sided|95.0|-3.1|0.8|||Constrained longitudinal data analysis|Model included terms for treatment, stratification factor, time, interaction of time by stratification factor and the interaction of time by treatment|||
1712302|NCT00806416|3151166|Non-Inferiority or Equivalence|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and a tablet containing 2800 IU vitamin D3, the geometric mean ratio (GMR) for AUC0-120 hr and Cmax, corrected for predose concentration, of the combination tablet/2800 IU vitamin D3 only tablet were contained within [0.80,1.25].|least-squares mean for Cmax|0.89||||||90.0|0.84|0.95||||||If the true GMR ratios for AUC and Cmax for 70 mg alendronate/vitamin D3 combination tablet with respect to 2800 IU vitamin D3 alone were 1.00 then a sample of N=28 provided >99% probability of yielding a 90% CI for both AUC0-120 hr and Cmax GMRs within the interval of [0.80, 1.25]. The within-subject standard deviation of 0.14 ln ng•hr/mL for AUC0-120 hr (ng•hr/mL) and 0.14 ng/mL for Cmax was obtained from another phase 1 study.|
1712303|NCT00806416|3151167|Non-Inferiority or Equivalence|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and a tablet containing 2800 IU vitamin D3, the geometric mean ratio (GMR) for AUC0-120 hr and Cmax, corrected for predose concentration, of the combination tablet/2800 IU vitamin D3 only tablet were contained within [0.80,1.25].|Least square mean ratio for AUC0-120 hr|0.88||||||90.0|0.81|0.95||||||If the true GMRs for AUC and Cmax for 70 mg alendronate/vitamin D3 combination tablet with respect to 2800 IU vitamin D3 alone were 1.00 then a sample size=28 provided >99% probability of yielding a 90% CI for both AUC(0-120 hr) and Cmax GMRs within the interval of [0.80, 1.25]. The within-subject standard deviation of 0.14 ln ng•hr/mL for AUC(0-120 hr) (ng•hr/mL) and 0.14 ng/mL for Cmax was obtained from another phase 1 study.|
1712304|NCT00806416|3151168|Non-Inferiority or Equivalence|Administration of a 70 mg alendronate/2800 IU vitamin D3 final market combination tablet and the 70 mg alendronate market tablet, the GMR of the combination tablet/alendronate only tablet are contained within [0.80,1.25].|Least square mean ratio|1.03||||||90.0|0.91|1.17||||||If the true geometric mean ratio (GMR) for total urinary excretion of alendronate of 70 mg alendronate/vitamin D3 combination tablet with respect to alendronate alone is 1.00 then a sample size =208 provided 99% probability of yielding a 90% CI for the total urinary excretion GMR within the interval of [0.80, 1.25]. These calculations were based on the observed-pooled within-subject standard deviation (log scale) of 0.521 obtained from earlier Phase 1 studies.|
1712305|NCT00806403|3151169|Superiority or Other|||||||0.21|||||||Fisher Exact||||
1712306|NCT00806403|3151170|Superiority or Other|||||||0.5|||||||Fisher Exact||||
1712307|NCT00806403|3151171|Superiority or Other|||||||0.04|||||||Fisher Exact|||Null hypothesis:there is no difference in number of patients with TIMI 3 flow at 5-7 days after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 65% reduction of failure to achive TIMI 3 flow (30% failure in thrombolysis group and 10% failure in Primary PCI group). With a power of 90% and a significance level of 0.05 (2-sided test), a total of 180 patients would be required.|
1712308|NCT00806403|3151172|Superiority or Other|||||||1|||||||Fisher Exact||||
1712309|NCT00806403|3151173|Superiority or Other|||||||0.56|||||||Fisher Exact|||Null hypothesis:there is no difference in ST resolution at 120 minutes after inclusion between thrombolysis and primary PCI. The power calculation was based on the aim to prove a 50% reduction of failure to achive at least a 50% ST resolution (40% failure in thrombolysis group and 20% failure in Primary PCI group). With a power of 80% and a significance level of 0.05 (2-sided test), a total of 166 patients would be required.|
1712310|NCT00806351|3151180|Superiority or Other||Risk Difference|-36.4|||||2-Sided|95.0|-90.6|31.9||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.|
1712311|NCT00806351|3151185|Superiority or Other||Risk Difference|-50.0|||||2-Sided|95.0|-97.5|55.0||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.|
1712312|NCT00806351|3151186|Superiority or Other||Risk Difference|-40.0|||||2-Sided|95.0|-97.5|63.9||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.|
1712313|NCT00806351|3151187|Superiority or Other||Risk Difference|-27.3|||||2-Sided|95.0|-80.9|40.3||||||The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.|
1712314|NCT00806351|3151188|Superiority or Other||Risk Difference|-27.3|||||2-Sided|95.0|-80.9|40.3||||||The 95 percent confidence interval (95% CI) was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.|
1712315|NCT00806286|3151192|Superiority|Two-sided p-value is calculated by dividing the square of the treatment group difference on the log-log scale by the standard error of the difference and referring the result to the standard normal distribution.|Mean Difference (Final Values)|-25.5|||<|0.0001|2-Sided||||||Z-test||The estimated value represents the difference in treatments (%).||
1712316|NCT00806286|3151193|Superiority||Cox Proportional Hazard|1.579||||0.0499|2-Sided|95.0|1.0|2.5|||Regression, Cox||||
1712317|NCT00806286|3151193|Superiority||Mean Difference (Final Values)|-23.2|||<|0.0001|2-Sided|||||Two-sided p-value is calculated by dividing the square of the treatment group difference on the log-log scale by the standard error of the difference and referring the result to the standard normal distribution.|Z-test||The estimated value represents the difference in treatments (%).||
1712320|NCT00806260|3151194|Non-Inferiority or Equivalence|non inferiority test|Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.05|||2-Sided|95.0|-0.18|0.04||||||at 6 hr timepoint|
1712321|NCT00806260|3151194|Non-Inferiority or Equivalence|non-inferiority|Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.06|||2-Sided|95.0|-0.17|0.07||||||at 2 hr timepoint|
1712322|NCT00806260|3151195|Non-Inferiority or Equivalence|step-down test|Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.06|||1-Sided|90.0|-0.03|||||||at alcohol level 0.04%|
1712323|NCT00806260|3151195|Non-Inferiority or Equivalence|step down test|Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.05|||1-Sided|90.0|0.12|||||||at alcohol level 0.07%|
1712324|NCT00806260|3151195|Non-Inferiority or Equivalence|step down test|Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.07|||1-Sided|90.0|0.21|||||||at alcohol level 0.10%|
1712325|NCT00806195|3151206|Non-Inferiority or Equivalence|The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines – PRoutine Vaccines) was <5%.|Mean Difference (Final Values)|0.3|||||2-Sided|95.0|-0.8|1.3||||||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was <5%.|
1712326|NCT00806195|3151206|Non-Inferiority or Equivalence|The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines – PRoutine Vaccines) was ≥5%.|Mean Difference (Final Values)|0.4|||||2-Sided|95.0|-0.9|1.5||||||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was <5%.|
1712327|NCT00806195|3151207|Non-Inferiority or Equivalence|The null hypothesis associated with the safety objective was that the upper limit of the two-sided 95% CI for this difference in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days after any vaccination (PMenACWY+Routine Vaccines–PRoutine Vaccines) was ≥ 6%.|Mean Difference (Final Values)|3.0|||||2-Sided|95.0|-0.8|6.4||||||MenACWY-CRM 197 administered concomitantly with routine vaccines was considered noninferior to routine vaccines alone with respect to severe systemic reactions if the upper limit of the 2-sided 95% CI of the difference (MenACWY-CRM197 vaccine plus routine vaccines group minus routine vaccines only group) in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days (days 1-7) after any vaccination was <6%.|
1712328|NCT00806026|3151219|Superiority or Other||LS mean difference|-0.55|Standard Error of the Mean|0.287||0.0553|2-Sided|95.0|-1.12|0.01||This analysis was not included in the step-down procedure (if p<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.|
1712329|NCT00806026|3151219|Superiority or Other||LS mean difference|-0.43|Standard Error of the Mean|0.282||0.1242|2-Sided|95.0|-0.99|0.12||This analysis was not included in the step-down procedure (if p<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.|
1712330|NCT00806026|3151219|Superiority or Other||LS mean difference|-1.0|Standard Error of the Mean|0.28||0.0004|2-Sided|95.0|-1.55|-0.45||This analysis was step 9 in a step-down procedure (if p<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze limb pain-VAS with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.|
1712331|NCT00806026|3151221|Superiority or Other||LS mean difference|-7.9|Standard Error of the Mean|3.69||0.0354|2-Sided|95.0|-15.2|-0.5||This analysis was not included in the step-down procedure (if p<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.|
1712332|NCT00806026|3151221|Superiority or Other||LS mean difference|2.4|Standard Error of the Mean|3.78||0.5299|2-Sided|95.0|-5.1|9.9||This analysis was not included in the step-down procedure (if p<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.|
1712333|NCT00806026|3151221|Superiority or Other||LS mean difference|-1.5|Standard Error of the Mean|3.93||0.7073|2-Sided|95.0|-9.3|6.3||This analysis was step 8 in a step-down procedure (if p<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze RLS-NDI with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.|
1712351|NCT00805870|3151257|Superiority or Other||Mean Difference (Net)|-1.845|Standard Error of the Mean|1.417|>|0.05|2-Sided|95.0|-4.823|1.132|||ANOVA|||Null hypothesis is that there is no difference in the amount of force applied to the quadriceps to elicit pain or discomfort between the fish oil and control groups.|
1712334|NCT00806026|3151227|Superiority or Other||LS mean difference|-4.57|Standard Error of the Mean|4.318||0.2906|2-Sided|95.0|-13.05|3.91||This analysis was not included in the step-down procedure (if p<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.|
1712335|NCT00806026|3151227|Superiority or Other||LS mean difference|-1.07|Standard Error of the Mean|4.408||0.8075|2-Sided|95.0|-9.73|7.58||This analysis was not included in the step-down procedure (if p<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.|
1712336|NCT00806026|3151227|Superiority or Other||LS mean difference|-17.25|Standard Error of the Mean|4.332|<|0.0001|2-Sided|95.0|-25.76|-8.74||This analysis was step 7 in a step-down procedure (if p<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze SSQ-Subjective WASO score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.|
1712337|NCT00806026|3151229|Superiority or Other|||||||0.0012||||||This analysis was step 3 in a step-down procedure (if p<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Log Rank|||For pramipexole 0.5 mg versus pregabalin 300 mg: Stratified log rank test by block (40 weeks versus 52 weeks of active treatment) was used to calculate p-value.|
1712338|NCT00806026|3151229|Superiority or Other|||||||0.0826||||||This analysis was step 6 in a step-down procedure (if p<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Log Rank|||For pramipexole 0.25 mg versus pregabalin 300 mg: Stratified log rank test by block (40 weeks versus 52 weeks of active treatment) was used to calculate p-value.|
1712339|NCT00806026|3151230|Superiority or Other|||||||0.0022||||||This analysis was not included in the step-down procedure (if p<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pramipexole 0.5 mg versus placebo: CMH test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.|
1712340|NCT00806026|3151230|Superiority or Other|||||||0.4393||||||This analysis was not included in the step-down procedure (if p<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pramipexole 0.25 mg versus placebo: CMH test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.|
1712341|NCT00806026|3151230|Superiority or Other||||||<|0.0001||||||This analysis was step 2 in a step-down procedure (if p<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Cochran-Mantel-Haenszel|||For pregabalin 300 mg versus placebo: Cochran-Mantel-Haenszel (CMH) test stratified by geographical region (US or EU) was used to analyze CGI-I responder status.|
1712342|NCT00806026|3151231|Superiority or Other||LS mean difference|-3.2|Standard Error of the Mean|0.67|<|0.0001|2-Sided|95.0|-4.5|-1.9||This analysis was not included in the step-down procedure (if p<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.5 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.|
1712343|NCT00806026|3151231|Superiority or Other||LS mean difference|-0.6|Standard Error of the Mean|0.68|<|0.3603|2-Sided|95.0|-2.0|0.7||This analysis was not included in the step-down procedure (if p<0.05, then continue to next step) to control Type I error. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pramipexole 0.25 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region (US or EU), treatment, week and treatment by week interaction as fixed effects.|
1712344|NCT00806026|3151231|Superiority or Other||Least squares (LS) mean difference|-4.5|Standard Error of the Mean|0.67|<|0.0001|2-Sided|95.0|-5.9|-3.2||This analysis was step 1 in a step-down procedure (if p<0.05, then continue to next step) used to control the Type I error rate. This procedure was stopped at Step 6. The analysis was done at a significance level of alpha = 0.05, 2-sided.|Mixed Models Analysis|Spatial power covariance structure was used.||For pregabalin 300 mg versus placebo: Mixed model analysis was used to analyze RLS symptom severity score with baseline value, region [United states (US) or European union (EU)], treatment, week and treatment by week interaction as fixed effects.|
1712345|NCT00805935|3151254|Superiority or Other|||||||0.483|||||||Fisher Exact|||Comparing Progesterone vaginal insert to Progesterone in oil within the follitropin beta treatment group.|
1712346|NCT00805935|3151254|Superiority or Other|||||||0.481|||||||Fisher Exact|||Comparing Progesterone vaginal insert to Progesterone in oil within the menotropin treatments arms.|
1712347|NCT00805935|3151254|Superiority or Other|||||||1|||||||Fisher Exact||||
1712348|NCT00805935|3151254|Superiority or Other|||||||1|||||||Fisher Exact||||
1712349|NCT00805870|3151255|Superiority or Other||Mean Difference (Net)|0.022|Standard Error of the Mean|0.188|>|0.05|2-Sided|95.0|-0.374|0.417|||ANOVA|||The null hypothesis is that there is no difference in interleukin-6 concentration between the fish oil and control groups.|
1712350|NCT00805870|3151256|Superiority or Other||Mean Difference (Net)|-57.015|Standard Error of the Mean|47.093|>|0.05|2-Sided|95.0|-156.373|42.344|||ANOVA|||Null hypothesis is that there is no difference in creatine kinase activity between the fish oil and the control groups.|
1712498|NCT00804570|3151472|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.77||||0.409|2-Sided|95.0|-2.62|1.07||P-value is for supine systolic blood pressure.|Mixed Models Analysis||||
1712352|NCT00805870|3151258|Superiority or Other||Mean Difference (Net)|8.271|Standard Error of the Mean|26.298|>|0.05|2-Sided|95.0|-63.521|46.978|||ANOVA|||Null hypothesis is that no difference is observed in quadriceps muscle strength between the fish oil and control groups.|
1712353|NCT00805792|3151260|Superiority or Other||||||<|0.001|||||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).|
1712354|NCT00805792|3151261|Superiority or Other||||||<|0.001|||||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).|
1712355|NCT00805792|3151262|Superiority or Other||||||<|0.001|||||||Regression, Linear|||The statistical significance of the change was assessed by the P value associated with estimated regression coefficient (beta coefficient or slope).|
1712356|NCT00805740|3151275|Superiority or Other||Risk Difference (RD)|-6.1|||||2-Sided|95.0|-39.0|27.9||||||The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.|
1712357|NCT00805740|3151277|Superiority or Other||Risk Difference (RD)|12.1|||||2-Sided|95.0|-23.3|47.3||||||6-week follow-up: The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.|
1712358|NCT00805740|3151277|Superiority or Other||Risk Difference (RD)|21.6|||||2-Sided|95.0|-13.6|55.6||||||2-week follow-up: The 95% CI was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.|
1712359|NCT00805740|3151278|Superiority or Other||Risk Difference (RD)|21.8|||||2-Sided|95.0|-12.3|53.3||||||The 95 percent (%) confidence interval (CI) was calculated using method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.|
1712360|NCT00805207|3151370|Other||||||>|0.1|||||||Tukey test||||
1712361|NCT00805207|3151370|Other||||||>|0.1|||||||Tukey test||||
1712362|NCT00805207|3151370|Other||||||<|0.01|||||||Tukey test||||
1712363|NCT00805207|3151370|Other||||||<|0.01|||||||Tukey test||||
1712364|NCT00805207|3151370|Other||||||<|0.05||||||P value is the group by treatment interaction from the ANOVA|ANOVA||||
1712365|NCT00805207|3151370|Other||||||<|0.96||||||P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA|ANOVA||||
1712366|NCT00805207|3151370|Other||||||<|0.01||||||P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA|ANOVA||||
1712367|NCT00805207|3151370|Other||||||<|0.001|||||||t-test, 2 sided||||
1712368|NCT00805207|3151371|Other|||||||0.8|||||||Wilcoxon (Mann-Whitney)||||
1712369|NCT00805207|3151372|Other|||||||0.23|||||||ANCOVA||||
1712370|NCT00805207|3151372|Other|||||||0.53|||||||ANCOVA||||
1712371|NCT00805207|3151372|Other||||||<|0.05|||||||ANCOVA||||
1712372|NCT00805207|3151372|Other||||||<|0.94|||||||t-test, 2 sided||||
1712373|NCT00805207|3151373|Other|||||||0.57|||||||ANCOVA||||
1712374|NCT00805207|3151373|Other|||||||0.87|||||||ANCOVA||||
1712375|NCT00805207|3151373|Other||||||<|0.05|||||||ANCOVA||||
1712376|NCT00805207|3151373|Other||||||<|0.82|||||||t-test, 2 sided||||
1712377|NCT00805207|3151373|Other||||||<|0.31|||||||t-test, 2 sided||||
1712378|NCT00805207|3151374|Other|||||||0.98||||||P value is the group by treatment interaction from the ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA|||
1712379|NCT00805207|3151374|Other|||||||0.26||||||P-value is the main effect of group (i.e., Testosterone, Progesterone, Estrogen and Control) from ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA|||
1712380|NCT00805207|3151374|Other|||||||0.88||||||P-value is the main effect of treatment (i.e., Before vs. After) from ANOVA|ANOVA|VLDL-TG secretion rates were skewed and log transformed prior to performing ANOVA|||
1712381|NCT00805207|3151374|Other|||||||0.7|||||||t-test, 2 sided||||
1712382|NCT00805207|3151374|Other|||||||0.85|||||||t-test, 2 sided||||
1712383|NCT00805194|3151377|Superiority or Other||Hazard Ratio (HR)|0.95||||0.4373|2-Sided|95.0|0.82|1.09||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs >= 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of pain|
1712384|NCT00805194|3151377|Superiority or Other||Hazard Ratio (HR)|1.05||||0.5203|2-Sided|95.0|0.91|1.2||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs >=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of dyspnoea|
1712385|NCT00805194|3151377|Superiority or Other||Hazard Ratio (HR)|0.9||||0.1858|2-Sided|95.0|0.77|1.05||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs >=1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib|Analysis evaluating the time to deterioration of cough|
1712386|NCT00805194|3151378|Superiority or Other||Hazard Ratio (HR)|1.03||||0.7282|2-Sided|95.0|0.87|1.21||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat.had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib||
1712499|NCT00804570|3151475|Superiority or Other (legacy)||Mean Difference (Final Values)|0.46||||0.633|2-Sided|95.0|-1.44|2.36|||Mixed Models Analysis||||
1713763|NCT00791765|3153291|Superiority or Other||||||<|0.0001|||||||van Elteren's test|Stratified by baseline body mass index group|||
1712387|NCT00805194|3151379|Superiority or Other||||||<|0.0001||||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the investigator's assessment|
1712388|NCT00805194|3151379|Superiority or Other||||||<|0.0001||||||P-value generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|ANOVA|||Analysis based on the central independent review|
1712389|NCT00805194|3151381|Superiority or Other||Odds Ratio (OR)|1.64|||<|0.0001|2-Sided|95.0|1.31|2.05||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio >1 indicates a benefit to nintedanib|Analysis based on investigator's assessment|
1712390|NCT00805194|3151381|Superiority or Other||Odds Ratio (OR)|1.68|||<|0.0001|2-Sided|95.0|1.35|2.09||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio >1 indicates a benefit to nintedanib|Analysis based on the central independent review|
1712391|NCT00805194|3151384|Superiority or Other||Odds Ratio (OR)|1.41||||0.0761|2-Sided|95.0|0.96|2.08||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio >1 indicates a benefit to nintedanib|Analysis based on the investigator's assessment|
1712392|NCT00805194|3151384|Superiority or Other||Odds Ratio (OR)|1.34||||0.3067|2-Sided|95.0|0.76|2.39||Odds ratio and p-value are obtained from logistic regression model adjusted for baseline ECOG PS (0 vs 1)|Regression, Logistic||An odds ratio >1 indicates a benefit to nintedanib|Analysis based on the central independent review|
1712393|NCT00805194|3151385|Superiority or Other||Hazard Ratio (HR)|0.82||||0.0012|2-Sided|95.0|0.73|0.93||HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib||
1712394|NCT00805194|3151386|Superiority or Other||Hazard Ratio (HR)|0.85||||0.007|2-Sided|95.0|0.75|0.96||HR, CI and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||HR below 1 favors nintedanib||
1712395|NCT00805194|3151387|Superiority or Other||Hazard Ratio (HR)|0.94||||0.272|2-Sided|95.0|0.83|1.05||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||The overall alpha level followed a Lan-DeMets spending function with O’Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05. HR below 1 favors nintedanib|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and <9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for all patients."|
1712396|NCT00805194|3151387|Superiority or Other||Hazard Ratio (HR)|0.83||||0.0359|2-Sided|95.0|0.7|0.99||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||"The overall alpha level followed a Lan-DeMets spending function with O’Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.~HR below 1 favors nintedanib"|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and <9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for patients with adenocarcinoma."|
1712397|NCT00805194|3151387|Superiority or Other||Hazard Ratio (HR)|0.75||||0.0073|2-Sided|95.0|0.6|0.92||HR, CI and p-value obtained from the prop. hazards model stratified by baseline ECOG PS (0 vs 1 - one pat. had 2), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|Regression, Cox||"The overall alpha level followed a Lan-DeMets spending function with O’Brien-Fleming shape parameter to preserve an overall 2-sided alpha level of 0.05.~HR below 1 favors nintedanib"|"Hierarchical testing was tested in a fixed sequence of statistical hypotheses in (1) patients with adenocarcinoma and <9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been rejected.~Overall survival for patients with adenocarcinoma and <9 months since start of first line therapy."|
1712398|NCT00805194|3151388|Superiority or Other||Hazard Ratio (HR)|0.79||||0.0019|2-Sided|95.0|0.68|0.92|||Regression, Cox||Hazard Ratio (HR) below 1 favors nintedanib|HR, Confidence Interval (CI) and p-value obtained from the proportional hazards model stratified by baseline ECOG PS (0 vs 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no)|
1712399|NCT00804986|3151409|Superiority or Other||Difference in mean change from baseline|-2.01||||0.0013||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712400|NCT00804986|3151409|Superiority or Other||Difference in mean change from baseline|-0.44||||0.4771||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712401|NCT00804986|3151409|Superiority or Other||Difference in mean change from baseline|-1.53||||0.0123||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712402|NCT00804986|3151409|Superiority or Other||Difference in mean change from baseline|-0.26||||0.6736||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712403|NCT00804986|3151409|Superiority or Other||Difference in mean change from baseline|-0.16||||0.8003||95.0||||p-value represents change from baseline to Week 12 for fasting weight, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712404|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.27||||0.062||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712405|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.12||||0.439||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712406|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.32||||0.029||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712407|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.04||||0.799||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712408|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.12||||0.403||95.0||||p-value represents change from baseline to Week 12 for fasting total cholesterol, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712409|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.21||||0.105||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712410|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.04||||0.792||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712411|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.21||||0.094||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712412|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.14||||0.277||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712413|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.04||||0.738||95.0||||p-value represents change from baseline to Week 12 for fasting LDL, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712414|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|0.01||||0.762||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712415|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.04||||0.42||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712416|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.03||||0.464||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712417|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.04||||0.401||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712418|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|0.01||||0.781||95.0||||p-value represents change from baseline to Week 12 for fasting HDL, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712419|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.09||||0.647||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 17.6 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712420|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.09||||0.648||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 12.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712421|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|-0.13||||0.506||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 6.2 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712422|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|0.31||||0.104||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 2.0 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712423|NCT00804986|3151410|Superiority or Other||Difference in mean change from baseline|0.08||||0.693||95.0||||p-value represents change from baseline to Week 12 for fasting triglycerides, 0.5 mg treatment arm in comparison to placebo|ANCOVA|ANCOVA: baseline and treatment|||
1712424|NCT00804986|3151413|Superiority or Other||Difference in mean change from baseline|-7786.69|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712425|NCT00804986|3151413|Superiority or Other||Difference in mean change from baseline|-6116.19|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712426|NCT00804986|3151413|Superiority or Other||Difference in mean change from baseline|-5547.95|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712427|NCT00804986|3151413|Superiority or Other||Difference in mean change from baseline|-1471.04|||<|0.3026||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712500|NCT00804570|3151476|Superiority or Other (legacy)||Mean Difference (Final Values)|0.77||||0.297|2-Sided|95.0|-0.68|2.22|||Mixed Models Analysis||||
1712428|NCT00804986|3151413|Superiority or Other||Difference in mean change from baseline|-1131.85|||<|0.4193||95.0||||p-value represents change from baseline to Week 12 total glucose AUC for 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712429|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-53.16|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712430|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-40.74|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712431|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-38.17|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712432|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-35.77|||<|0.0008||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712433|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-24.02|||<|0.0199||95.0||||p-value represents change from baseline to Week 12 for prior to bed glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712434|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-49.9|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712435|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-29.59|||<|0.004||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712436|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-35.19|||<|0.0004||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712437|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-21.13|||<|0.0413||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, visit, treatment and visit by treatment interaction as fixed effects|||
1712438|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-11.84|||<|0.2468||95.0||||p-value represents change from baseline to Week 12 for 2 hours post dinner glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712439|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-46.26|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712440|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-40.34|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712441|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-38.55|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712442|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-34.26|||<|0.0002||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712443|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-24.69|||<|0.006||95.0||||p-value represents change from baseline to Week 12 for prior to dinner glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712444|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-43.47|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712445|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-24.66|||<|0.0101||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712446|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-33.13|||<|0.0003||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712447|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-12.49|||<|0.1938||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712448|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-6.41|||<|0.503||95.0||||p-value represents change from baseline to Week 12 for 2 hours post lunch glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712449|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-40.36|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712450|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-36.07|||<|0.0002||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712451|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-39.41|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712452|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-21.91|||<|0.0221||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712453|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-20.21|||<|0.0335||95.0||||p-value represents change from baseline to Week 12 for prior to lunch glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712454|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-51.38|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712455|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-43.05|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712456|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-42.49|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712457|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-29.72|||<|0.0072||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712458|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-5.32|||<|0.6279||95.0||||p-value represents change from baseline to Week 12 for 2 hours post breakfast glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712459|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-35.25|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712460|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-30.45|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712461|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-32.52|||<|0.0001||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712462|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-19.48|||<|0.0029||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712463|NCT00804986|3151414|Superiority or Other||Difference in mean change from baseline|-4.54|||<|0.4848||95.0||||p-value represents change from baseline to Week 12 for fasting glucose, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712464|NCT00804986|3151417|Superiority or Other||Difference in mean change from baseline|-6.02||||0.221||95.0||||p-value represents change from baseline to Week 12 for how full, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712465|NCT00804986|3151417|Superiority or Other||Difference in mean change from baseline|-8.05||||0.105||95.0||||p-value represents change from baseline to Week 12 for how full, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712466|NCT00804986|3151417|Superiority or Other||Difference in mean change from baseline|-4.45||||0.357||95.0||||p-value represents change from baseline to Week 12 for how full, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712467|NCT00804986|3151417|Superiority or Other||Difference in mean change from baseline|-7.4||||0.135||95.0||||p-value represents change from baseline to Week 12 for how full, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712468|NCT00804986|3151417|Superiority or Other||Difference in mean change from baseline|2.89||||0.561||95.0||||p-value represents change from baseline to Week 12 for how full, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712469|NCT00804986|3151417|Superiority or Other||Difference in mean change from baseline|2.84||||0.508||95.0||||p-value represents change from baseline to Week 12 for hunger, 17.6 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712501|NCT00804570|3151477|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.04||||0.856|2-Sided|95.0|-0.49|0.4||P-value is for goal related to alcohol use.|ANCOVA||||
1712470|NCT00804986|3151417|Superiority or Other||Difference in mean change from baseline|3.3||||0.446||95.0||||p-value represents change from baseline to Week 12 for hunger, 12.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712471|NCT00804986|3151417|Superiority or Other||Difference in mean change from baseline|0.45||||0.914||95.0||||p-value represents change from baseline to Week 12 for hunger, 6.2 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712472|NCT00804986|3151417|Superiority or Other||Difference in mean change from baseline|3.36||||0.436||95.0||||p-value represents change from baseline to Week 12 for hunger, 2.0 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712473|NCT00804986|3151417|Superiority or Other||Difference in mean change from baseline|1.93||||0.655||95.0||||p-value represents change from baseline to Week 12 for hunger, 0.5 mg treatment arm in comparison to placebo|Mixed Models Analysis|Mixed effects model: baseline, treatment, visit, treatment-by-visit interaction|||
1712474|NCT00804986|3151418|Superiority or Other||Difference in mean change from baseline|-1.24|||<|0.0001|2-Sided|95.0|-1.59|-0.88||p-value represents change from baseline to Week 12 HbA1c for 17.6 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction|||
1712475|NCT00804986|3151418|Superiority or Other||Difference in mean change from baseline|-1.28|||<|0.0001|2-Sided|95.0|-1.64|-0.93||p-value represents change from baseline to Week 12 HbA1c for 12.0 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction|||
1712476|NCT00804986|3151418|Superiority or Other||Difference in mean change from baseline|-1.11|||<|0.0001|2-Sided|95.0|-1.46|-0.76||p-value represents change from baseline to Week 12 HbA1c for 6.2 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction|||
1712477|NCT00804986|3151418|Superiority or Other||Difference in mean change from baseline|-0.67|||<|0.0003|2-Sided|95.0|-1.02|-0.31||p-value represents change from baseline to week 12 HbA1c for 2.0 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction|||
1712478|NCT00804986|3151418|Superiority or Other||Difference in mean change from baseline|-0.47|||<|0.0109|2-Sided|95.0|-0.83|-0.11||p-value represents change from baseline to Week 12 HbA1c for 0.5 mg treatment arm in comparison to placebo with values <0.05 considered to be statistically significant.|Mixed Models Analysis|Mixed effects model: baseline HbA1c, metformin use, treatment, visit, treatment-by-visit interaction|||
1712479|NCT00804908|3151436|Superiority or Other||||||=|0|||||||Stratified log-rank|||Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; >1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.|
1712480|NCT00804908|3151436|Superiority or Other||||||=|0|||||||Stratified log-rank|||Comparisons between treatment groups were performed using a Comparisons between treatment groups were performed using a log-rank test stratified by baseline lactate dehydrogenase (LDH) status (0 to 1 ULN; >1 to ≤ 2 ULN) and history of previously treated brain metastases (with, without). Hochberg testing procedure for multiplicity adjustment.|
1712481|NCT00804843|3151438|Superiority or Other||Least Square Mean Difference|3.64||||0.898|2-Sided|90.0|-1.09|8.36|||ANOVA||||
1712482|NCT00804843|3151439|Superiority or Other||Least Square Mean Difference|0.27||||0.811|2-Sided|90.0|-0.24|0.78|||ANOVA||||
1712483|NCT00804687|3151447|Superiority or Other||Least Squares Mean difference|-3.905|Standard Error of the Mean|2.277||0.0895|2-Sided|95.0|-8.424|0.614|||Linear mixed model||||
1712484|NCT00804687|3151447|Superiority or Other||Least Squares Mean difference|4.699|Standard Error of the Mean|2.289||0.0428||95.0|0.155|9.243|||Linear mixed model||||
1712485|NCT00804687|3151447|Superiority or Other||Least Squares Mean difference|8.604|Standard Error of the Mean|2.267||0.0003||95.0|4.104|13.104|||Linear mixed model||||
1712486|NCT00804687|3151448|Superiority or Other||Least Squares Mean difference|-0.066|Standard Error of the Mean|0.07||0.3513|2-Sided|95.0|-0.206|0.075|||Linear mixed model||||
1712487|NCT00804687|3151448|Superiority or Other||Least Squares Mean difference|-0.195|Standard Error of the Mean|0.067||0.0043||95.0|-0.328|-0.063|||Linear mixed model||||
1712488|NCT00804687|3151448|Superiority or Other||Least Squares Mean difference|-0.126|Standard Error of the Mean|0.066||0.0602||95.0|-0.258|0.006|||Linear mixed model||||
1712489|NCT00804570|3151464|Superiority or Other (legacy)||Mean Difference (Final Values)|0.57|||<|0.001|2-Sided|95.0|0.24|0.9|||Mixed Models Analysis||||
1712490|NCT00804570|3151466|Superiority or Other (legacy)||Mean Difference (Final Values)|0.74||||0.077|2-Sided|95.0|-0.08|1.57|||Mixed Models Analysis||||
1712491|NCT00804570|3151467|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.31||||0.4|2-Sided|95.0|-1.05|0.42||P-value is for orthostatic diastolic blood pressure.|Mixed Models Analysis||||
1712492|NCT00804570|3151467|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.69||||0.235|2-Sided|95.0|-1.82|0.45||P-value is for orthostatic systolic blood pressure.|Mixed Models Analysis||||
1712493|NCT00804570|3151468|Superiority or Other (legacy)|||||||0.002|||||||Fisher Exact||||
1712494|NCT00804570|3151469|Superiority or Other (legacy)|||||||0.122|||||||Fisher Exact||||
1712495|NCT00804570|3151470|Superiority or Other (legacy)||Mean Difference (Final Values)|-2.08||||0.081|2-Sided|95.0|-4.41|0.26|||Mixed Models Analysis||||
1712496|NCT00804570|3151471|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.53||||0.456|2-Sided|95.0|-1.93|0.87|||Mixed Models Analysis||||
1712497|NCT00804570|3151472|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.45||||0.452|2-Sided|95.0|-1.63|0.73||P-value is for supine diastolic blood pressure.|Mixed Models Analysis||||
1712502|NCT00804570|3151477|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.48||||0.19|2-Sided|95.0|-1.2|0.24||P-value is for difficulty to quit and remain abstinent.|ANCOVA||||
1712503|NCT00804570|3151477|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.2||||0.545|2-Sided|95.0|-0.85|0.45||P-value is for expectation of success in quitting alcohol.|ANCOVA||||
1712504|NCT00804570|3151477|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.48||||0.69|2-Sided|95.0|-1.01|0.04||P-value is for desire to stop drinking at this time.|ANCOVA||||
1712505|NCT00804570|3151478|Superiority or Other (legacy)||Mean Difference (Final Values)|1.25||||0.142|2-Sided|95.0|-0.42|2.92|||ANCOVA||||
1712506|NCT00804570|3151479|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.44||||0.185|2-Sided|95.0|-1.1|0.21|||Mixed Models Analysis||||
1712507|NCT00804570|3151480|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.32||||0.392|2-Sided|95.0|-1.05|0.41|||Mixed Models Analysis||||
1712508|NCT00804570|3151481|Superiority or Other (legacy)||GMR over Baseline relative to placebo|0.94||||0.012|2-Sided|95.0|0.89|0.99|||Mixed Models Analysis||||
1712509|NCT00804570|3151482|Superiority or Other (legacy)||GMR over Baseline relative to placebo|0.96||||0.103|2-Sided|95.0|0.91|1.01|||Mixed Models Analysis||||
1712510|NCT00804570|3151483|Superiority or Other (legacy)||GMR over Baseline relative to placebo|0.9||||0.001|2-Sided|95.0|0.85|0.96|||Mixed Models Analysis||||
1712511|NCT00804570|3151484|Superiority or Other (legacy)||Mean Difference (Final Values)|-3.01||||0.034|2-Sided|95.0|-5.8|-0.22|||Mixed Models Analysis||||
1712512|NCT00804570|3151485|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.68||||0.318|2-Sided|95.0|-2.03|0.66|||Mixed Models Analysis||||
1712513|NCT00804570|3151486|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.44||||0.199|2-Sided|95.0|-1.12|0.23|||Mixed Models Analysis||||
1712514|NCT00804570|3151487|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.4||||0.249|2-Sided|95.0|-1.07|0.28|||Mixed Models Analysis||||
1712515|NCT00804570|3151488|Superiority or Other (legacy)||Mean Difference (Final Values)|5.37||||0.051|2-Sided|95.0|-0.02|10.77|||Mixed Models Analysis||||
1712516|NCT00804570|3151489|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.71||||0.013|2-Sided|95.0|-1.27|-0.15|||Mixed Models Analysis||||
1712517|NCT00804570|3151490|Superiority or Other (legacy)||Mean Difference (Final Values)|-4.3||||0.12|2-Sided|95.0|-9.72|1.13|||Mixed Models Analysis||||
1712518|NCT00804193|3151495|Non-Inferiority or Equivalence|90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald’s method with Yates’ continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).|Difference in Percentage of Participants|4.0||||0.001|2-Sided|90.0|-4.6|14.24|||Wald's method Yates' continuity cor||The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.||
1712519|NCT00804193|3151496|Non-Inferiority or Equivalence|90% CI was constructed for the difference in the Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald’s method with Yates’ continuity correction. Bioequivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20).|Difference in Percentage of Participants|1.0||||0.001|2-Sided|90.0|-7.08|9.24|||Wald's method with Yates' continuity cor||The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.||
1712520|NCT00804193|3151497|Non-Inferiority or Equivalence|90% CI was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald’s method with Yates’ continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% CI was contained within the interval -0.20 to +0.20 (-20% to +20%).|Difference in Percentage of Participants|9.0|||||2-Sided|90.0|-0.69|18.85|||||The sample size for this study was calculated assuming that both active treatments would have equivalent success proportions of at least 55% and the Vehicle would have a success proportion no greater than 25%.||
1712521|NCT00803959|3151500|Superiority or Other|||||||0.19||||||P-values was not adjusted for multiple comparisons and the a priori threshold for statistical significance was set at alpha = 0.05.|Chi-squared|Chi-squared test had 1 df and no adjustments.||Null hypothesis is that the proportion having a positive provocative stress test at 12 months was the same in both treatment arms.|
1712522|NCT00803959|3151501|Superiority or Other|||||||0.28||||||P-value was not adjusted for multiple comparisons and the a priori threshold for statistical significance was alpha = 0.05.|t-test, 2 sided|T test had 1 df and assumed equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ according to mean overall patient satisfaction score at 12 months.|
1712523|NCT00803959|3151502|Superiority or Other|||||||0.51|||||||Chi-squared|Chi-squared test had 1 df and no adjustments.||Null hypothesis is that the 2 arms do not differ in the proportion of women who score moderate or severe on the PGI-S at 12 months|
1712524|NCT00803959|3151503|Superiority or Other|||||||0.51|||||||t-test, 2 sided|The t test had 1 df and assumed equal variance; no evidence of different variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in PGI-S score.|
1712525|NCT00803959|3151504|Superiority or Other|||||||0.02||||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|T test had 1 df assuming equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in SF-12 scores.|
1712526|NCT00803959|3151505|Superiority or Other|||||||0.49||||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05|t-test, 2 sided|T test had 1 df and assumed equal variance; no evidence of different variances was found.||Null hypothesis is that the 2 arms do not differ according to mean change in IIQ score.|
1712551|NCT00803712|3151541|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.|||
1713781|NCT00791648|3153333|Superiority or Other (legacy)|||||||0.56|||||||Wilcoxon (Mann-Whitney)||||
1712527|NCT00803959|3151506|Superiority or Other|||||||0.19||||||P-value not adjusted for multiple comparisons and a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|The t test had 1 df and assumed equal variances; no evidence of different variances was found.||Null hypothesis is that the two arms do not differ according to change in MESA urgency score.|
1712528|NCT00803959|3151507|Superiority or Other|||||||0.5||||||P-value not adjusted for multiple comparisons; a priori threshold was alpha = 0.05.|t-test, 2 sided|The t test had 1 df assuming equal variances; no evidence of unequal variances was found.||Null hypothesis is that the 2 arms do not differ in change in MESA stress score.|
1712529|NCT00803959|3151508|Superiority or Other|||||||0.4||||||P-value was not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.|t-test, 2 sided|Test was 1 df t-test assuming equal variances; no evidence to the contrary was found.||Null hypothesis is that the 2 arms do not differ according to change in ISI score.|
1712530|NCT00803959|3151509|Superiority or Other|||||||0.68||||||P-value is not adjusted for multiple comparisons; a priori threshold for statistical significance was set at alpha = 0.05.|t-test, 2 sided|One df t test assumed equal variance; no evidence was found to the contrary.||Null hypothesis is that the two arms do not differ according to change in UDI score.|
1712531|NCT00803959|3151510|Superiority or Other|||||||0.68||||||P-value not adjusted for multiple comparisons; a priori threshold for statistical significance set at alpha = 0.05.|Chi-squared|No adjustments made; 1 degree of freedom test.||"Null hypothesis is that there is no difference in the proportion responding very much better or much better on the Patient Global Impression of Improvement at the 12 month visit."|
1712532|NCT00803959|3151511|Superiority or Other|||||||0.63||||||The p-value is not adjusted for multiple comparisons. Alpha level is considered to be 0.05.|Chi-squared|No adjustments were made; test had 1 degree of freedom.||Null hypothesis is that the two groups will not differ in the percent meeting 70% reduction in Urogenital Distress Inventory score.|
1712533|NCT00803959|3151512|Non-Inferiority or Equivalence|The investigators selected the 11% noninferiority margin on the basis of clinical judgement that it was a reasonable threshold for a trade-off between a decrease in the rate of successful treatment and the potential benefits of eliminating UDS studies from preoperative assessment. To minimize bias toward noninferiority, only women treated per protocol (e.g. who underwent the randomly assigned evaluation) were considered in the primary outcome analysis (ITT analysis considered secondary).|Difference in success % (UDS - no UDS)|-0.3|||||2-Sided|95.0|-7.5|6.9|||||Point estimates of success percentage are calculated as 200/259= 77.2% for Office Evaluation Only and 203/264 = 76.9% for Urodynamic Testing arm.|The null hypothesis was that the no UDS group was non-inferior to those in the UDS group. Assuming a significance level of 5% and a true success rate in each group of 70% with a noninferiority margin of 11 percentage points, we needed to enroll 270 women/group to have 80% power for determining whether the results in the no UDS group were non inferior to those in the UDS group. Assuming a 10% dropout rate, a sample of 300 women per group was required.|
1712534|NCT00803790|3151513|Superiority or Other||Least Square Mean Ratio|0.94|||||2-Sided|90.0|0.88|1.0||||||"Least squares mean ratio for Cmax for vitamin D following administration of combination tablet and vitamin D alone.~No correction for endogenous Vitamin D concentration pre-treatment was made in the analysis."|
1712535|NCT00803790|3151514|Superiority or Other||Least Square Mean Ratio|0.94|||||2-Sided|90.0|0.89|1.0||||||Least squares mean ratio for AUC 0-80 hr for vitamin D following administration of combination tablet and vitamin D alone. No correction for endogenous Vitamin D concentration pre-treatment was made in the analysis.|
1712536|NCT00803790|3151515|Superiority or Other||least square mean ratio|1.01|||||2-Sided|90.0|0.92|1.11|||||||
1712537|NCT00803751|3151521|Superiority or Other|||||||0.0004|||||||t-test, 2 sided||||
1712538|NCT00803751|3151522|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1712539|NCT00803751|3151523|Superiority or Other|||||||0.002|||||||t-test, 2 sided||||
1712540|NCT00803751|3151524|Superiority or Other|||||||0.36|||||||t-test, 2 sided||||
1712541|NCT00803751|3151525|Superiority or Other|||||||0.45|||||||Fisher Exact||||
1712542|NCT00803751|3151526|Superiority or Other|||||||0.17|||||||Fisher Exact||||
1712543|NCT00803738|3151527|Non-Inferiority or Equivalence|A 90% confidence interval was constructed on the difference in the clinical cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||2-Sided|90.0|-1.35|16.88|||||||
1712544|NCT00803738|3151528|Non-Inferiority or Equivalence|A 90% confidence interval was constructed on the difference in the mycological cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald's method with Yates' continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-20% to +20%).|proportion of subjects in trtmt groups|0.05|||||2-Sided|90.0|-4.66|11.49|||||||
1712545|NCT00803738|3151529|Non-Inferiority or Equivalence|For the primary clinical equivalence analysis, a 90% confidence interval was constructed on the difference in the therapeutic cure rates between the Test Product and Reference Product at the Test-of-Cure visit (Visit 3). The interval was calculated using Wald’s method with Yates’ continuity correction. Clinical equivalence was established if this 90% confidence interval was contained within the interval –0.20 to +0.20 (–20% to +20%).|proportion of subjects in trtmt groups|0.05|||||2-Sided|90.0|-4.3|15.02|||||||
1712546|NCT00803712|3151536|Superiority or Other|||||||0.7518|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.|||
1712547|NCT00803712|3151537|Superiority or Other|||||||0.3546|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.|||
1712548|NCT00803712|3151538|Superiority or Other|||||||0.071|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.|||
1712549|NCT00803712|3151539|Superiority or Other|||||||0.0085|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline serum phosphorus.|||
1712550|NCT00803712|3151540|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.|||
1713782|NCT00791648|3153334|Superiority or Other (legacy)|||||||0.75|||||||Pearson x2||||
1712552|NCT00803712|3151542|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium.|||
1712553|NCT00803712|3151543|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata and baseline corrected serum calcium|||
1712554|NCT00803712|3151544|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata.|||
1712555|NCT00803712|3151545|Superiority or Other|||||||0.004|||||||ANCOVA|Analysis was adjusted for randomization strata. Due to distributional properties of the data, analysis was performed on log-transformed data|||
1712556|NCT00803712|3151546|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata.|||
1712557|NCT00803712|3151547|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis was adjusted for randomization strata. Due to distributional properties of the data, analysis was performed on log-transformed data|||
1712558|NCT00803712|3151548|Superiority or Other|||||||0.4436|||||||Cochran-Mantel-Haenszel||||
1712559|NCT00803712|3151549|Superiority or Other|||||||0.3298|||||||Cochran-Mantel-Haenszel||||
1712560|NCT00803712|3151550|Superiority or Other|||||||0.0611|||||||Cochran-Mantel-Haenszel||||
1712561|NCT00803712|3151551|Superiority or Other|||||||0.0003|||||||Cochran-Mantel-Haenszel||||
1712562|NCT00803712|3151552|Superiority or Other|||||||0.952|||||||Cochran-Mantel-Haenszel||||
1712563|NCT00803712|3151553|Superiority or Other|||||||0.091|||||||Cochran-Mantel-Haenszel||||
1712564|NCT00803712|3151554|Superiority or Other|||||||0.4304|||||||Cochran-Mantel-Haenszel||||
1712565|NCT00803712|3151555|Superiority or Other|||||||0.0875|||||||Cochran-Mantel-Haenszel||||
1712566|NCT00803712|3151556|Superiority or Other|||||||0.2386||||||Multiplicity adjusted p-value is presented, adjusted using the Dubey and Armitage-Parmer method|Cochran-Mantel-Haenszel||||
1712567|NCT00803712|3151557|Superiority or Other|||||||0.0139||||||Adjusted p-value is presented. P-value is adjusted using Dubey and Armitage-Parmer method of adjusting for multiple comparisons|Cochran-Mantel-Haenszel||||
1712568|NCT00803712|3151558|Superiority or Other|||||||0.0002||||||Multiplicity adjusted p-value is presented, adjusted using the Dubey and Armitage-Parmer method|Cochran-Mantel-Haenszel||||
1712569|NCT00803712|3151559|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Hypothesis to be tested: the proportion of participants achieving the specified PTH target of ≥ 30% reduction in PTH from baseline will be greater in the cinacalcet plus low dose active vitamin D group than in the control group during the efficacy assessment phase at month 6 (weeks 22 to 26).|
1712570|NCT00803595|3151579|Superiority or Other||Median Difference (Final Values)|-2.7||||0.344|2-Sided|95.0|-9.1|3.1||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.|
1712571|NCT00803595|3151579|Superiority or Other||Median Difference (Final Values)|0.6||||0.981|2-Sided|95.0|-5.8|5.7||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.|
1712572|NCT00803595|3151579|Superiority or Other||Median Difference (Final Values)|3.3||||0.318|2-Sided|95.0|-2.8|9.1||2-sided P value without adjustments for multiple testing.|Generalized Wilcoxon test|||Null hypothesis was that there was no difference in the time for return to normal axillary temperature.|
1712573|NCT00803595|3151580|Non-Inferiority or Equivalence|A noninferiority margin of 18 hours was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.|Median Difference (Final Values)|12.2||||0.104|2-Sided|95.0|-1.5|17.2|||Generalized Wilcoxon test|||This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not >18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.|
1712574|NCT00803595|3151580|Superiority or Other||Median Difference (Final Values)|-12.8||||0.038|2-Sided|95.0|-18.2|-0.4||2-sided p-value without adjustments for multiple testing|Generalized Wilcoxon Test|||Null hypothesis was that there was no difference in the time to illness alleviation|
1712575|NCT00803595|3151580|Non-Inferiority or Equivalence|A noninferiority margin of 18 hours (h) was set to assure the superiority of laninamivir octanoate over a putative placebo. A meta-analysis using 3 placebo-controlled trials reported that the difference between the median time to illness alleviation in the placebo and oseltamivir groups was 33.1 h and the 95% confidence interval ranged from 19.1 to 47.1 h. From this, a margin that was less than the lower limit of this 95% CI was selected.|Median Difference (Final Values)|-0.6||||0.748|2-Sided|95.0|-9.9|6.9||2-sided p-value without adjustments for multiple testing|Generalized Wilcoxon Test|||This trial was designed to confirm the efficacy of laninamivir octanoate by showing that the median time to illness alleviation in patients treated with laninamivir octanoate was not >18 hours longer than that in patients treated with oseltamivir. Sample size of 300 patients in each group was determined to achieve a power of at least 80% to show noninferiority at both dose levels of laninamivir octanoate with use of a Monte Carlo simulation.|
1712576|NCT00803452|3151592|Superiority|||||||0.001|||||||t-test, 2 sided||||
1712577|NCT00803361|3151598|Superiority or Other||Mean Difference (Final Values)|-0.83||||0.068|2-Sided|95.0|-1.72|0.06||p-value is for Change from Baseline|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712578|NCT00803361|3151599|Superiority or Other||Mean Difference (Final Values)|-7.15||||0.011|2-Sided|95.0|-12.64|-1.66||p-value is for Pain During Waking Hours, Past Week, Change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712579|NCT00803361|3151599|Superiority or Other||Mean Difference (Final Values)|-3.67||||0.145|2-Sided|95.0|-8.61|1.28||p-value is for Pain Interference, Daily Activities, Change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712609|NCT00803114|3151642|Superiority or Other|||||||0.8||||||Fisher's exact test result did not reveal statistically significant differences between expected and real frequencies in any of the categories.|Fisher Exact||||
1712580|NCT00803361|3151599|Superiority or Other||Mean Difference (Final Values)|-2.93||||0.26|2-Sided|95.0|-8.06|2.19||p-value is for Severity of Shoulder Pain, Past Week, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712581|NCT00803361|3151599|Superiority or Other||Mean Difference (Final Values)|-6.03||||0.025|2-Sided|95.0|-11.3|-0.76||p-value is for Severity of Back Pain, Past Week, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712582|NCT00803361|3151599|Superiority or Other||Mean Difference (Final Values)|-1.21||||0.66|2-Sided|95.0|-6.64|4.22||p-value is for Severity of Headaches, Past Week, Change.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline|||
1712583|NCT00803361|3151599|Superiority or Other||Mean Difference (Final Values)|-5.32||||0.063|2-Sided|95.0|-10.93|0.3||p-value is for Severity of Overall Pain, Past Week, Change|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline|||
1712584|NCT00803361|3151600|Superiority or Other||Mean Difference (Final Values)|-1.62||||0.083|2-Sided|95.0|-3.46|0.21||p-value is for Global Functional Impairment Total Score - change|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712585|NCT00803361|3151600|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.087|2-Sided|95.0|-1.14|0.08||p-value is for symptoms disrupted family life - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712586|NCT00803361|3151600|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.14|2-Sided|95.0|-1.16|0.17||p-value is for symptoms disrupted social/leisure - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712587|NCT00803361|3151600|Superiority or Other||Mean Difference (Final Values)|-0.61||||0.076|2-Sided|95.0|-1.29|0.06||p-value is for symptoms have disrupted your work/schoolwork - change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712588|NCT00803361|3151601|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.22|2-Sided|95.0|-0.67|0.16||p-value is for Mean Interference Score, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712589|NCT00803361|3151601|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.186|2-Sided|95.0|-0.85|0.17||p-value is for Interference of Pain, Enjoyment of Life, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712590|NCT00803361|3151601|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.731|2-Sided|95.0|-0.63|0.44||p-value is for Interference of Pain, Sleep, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712591|NCT00803361|3151601|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.395|2-Sided|95.0|-0.59|0.24||p-value is for Interference of Pain, Relations with Others, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712592|NCT00803361|3151601|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.367|2-Sided|95.0|-0.71|0.26||p-value is for Interference of Pain, Normal Work, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712593|NCT00803361|3151601|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.149|2-Sided|95.0|-0.72|0.11||p-value is for Interference of Pain,Walking Ability, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712594|NCT00803361|3151601|Superiority or Other||Mean Difference (Final Values)|-0.31||||0.252|2-Sided|95.0|-0.83|0.22||p-value is for Interference of Pain, Mood, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712595|NCT00803361|3151601|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.101|2-Sided|95.0|-0.87|0.08||p-value is for Interference of Pain, General Activity, Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712596|NCT00803361|3151601|Superiority or Other||Mean Difference (Final Values)|-0.69||||0.002|2-Sided|95.0|-1.14|-0.25||p-value is for Severity of Pain Right Now Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712597|NCT00803361|3151601|Superiority or Other||Mean Difference (Final Values)|-0.52||||0.012|2-Sided|95.0|-0.93|-0.11||p-value is for Severity of Average Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712598|NCT00803361|3151601|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.014|2-Sided|95.0|-0.75|-0.09||p-value is for Severity of Least Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712599|NCT00803361|3151601|Superiority or Other||Mean Difference (Final Values)|-0.41||||0.125|2-Sided|95.0|-0.93|0.11||p-value is for Severity of Worst Pain Change.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712600|NCT00803361|3151602|Superiority or Other||Mean Difference (Final Values)|-0.44||||0.004|2-Sided|95.0|-0.74|-0.15|||ANOVA||||
1712601|NCT00803361|3151603|Superiority or Other||Mean Difference (Final Values)|-2.56||||0.024|2-Sided|95.0|-4.78|-0.34||p-value is for Change from Baseline|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712602|NCT00803361|3151604|Superiority or Other||Mean Difference (Final Values)|-1.62||||0.006|2-Sided|95.0|-2.76|-0.48||p-value is for Change from Baseline.|ANCOVA|Change = Treatment + Pooled Investigator + Baseline|||
1712603|NCT00803270|3151615|Superiority or Other||difference of proportions|0.45|Standard Error of the Mean|0.21||0.08|2-Sided|95.0|0.03|0.87||Fisher's Exact Test of equality of percent meeting optimal outcome.|Fisher Exact||||
1712604|NCT00803270|3151616|Superiority or Other||Difference of proportions|0.08|Standard Error of the Mean|0.19||0.99|2-Sided|95.0|-0.28|0.44|||Fisher Exact||||
1712605|NCT00803244|3151617|Superiority or Other||LS Mean difference vs. Placebo|-0.09||||0.0401|2-Sided|95.0|-0.18|0.0|||ANCOVA||Relative LS Means difference (%) = -19.7||
1712606|NCT00803244|3151618|Superiority or Other||Difference in LS Means|-0.49||||0.2344||95.0|-1.3|0.32|||ANCOVA||||
1712607|NCT00803205|3151637|Superiority||Mean Difference (Final Values)|2.754|Standard Error of the Mean|1.78124||0.1235|2-Sided|95.0|-0.756|6.264||The p-value is the LS-mean for the comparison between active treatment and placebo. The level of significance was 0.04998.|Mixed Models Analysis|||Least squares (LS) mean estimates based on mixed model for repeated measures (Weeks 8, 16, 24, 32, 40 and 48) of relative change in percent-predicted FEV1 as the dependent variable; independent variables including Baseline percent-predicted FEV1, treatment, visit, interactions between treatment and visit and between Baseline percent-predicted FEV1 and visit; and stratification factors of Baseline age, Baseline inhaled antibiotics, and Baseline percent-predicted FEV1.|
1712608|NCT00803205|3151638|Superiority|||||||0.3264|||||||ANOVA||||
1712656|NCT00800683|3151887|Superiority or Other||Mean Difference (Final Values)|4.37|Standard Error of the Mean|8.27||0.5984||95.0|-12.02|20.75|||ANCOVA||||
1712610|NCT00803114|3151643|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|0.3||0.05||95.0|0.7|1.8|||t-test, 2 sided|degrees of freedom 212|Difference in VAS score when compared to the baseline group, subjects receiving epidural morphine||
1712611|NCT00803114|3151644|Superiority or Other||Mean Difference (Final Values)|-4.0|Standard Error of the Mean|0.8||0.05||95.0|-5.7|-2.3|||t-test, 2 sided|degrees of freedom 226|The epidural morphine group represents the baseline of comparison for difference in means, with the placebo group requiring additional analgesics earlier.||
1712612|NCT00803114|3151645|Superiority or Other||Risk Ratio (RR)|0.22||||0.05||95.0|0.12|0.41|||Fisher Exact||Relative risk describes the risk of requiring additional analgesics in the first 24 hours postpartum with the denominator being the arm which received placebo.|Relative risk ratio estimation with 95% CI using exact methods|
1712613|NCT00803101|3151651|Non-Inferiority or Equivalence|"The non-inferiority margin was −(minus)10%. If the lower limit of the 2-sided 95% CI was >–10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated ‘effective’ in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 80 participants."|Difference in effective hemostasis (%)|45.3|||||2-Sided|95.0|31.9|56.4||||||The analysis of rapid decrease of the INR was via calculation of the 95% CI for the difference (Beriplex minus plasma) in the percentage of participants with INR ≤ 1.3 at 30 minutes after the end of infusion.|
1712614|NCT00803101|3151652|Non-Inferiority or Equivalence|"The non-inferiority margin was −(minus)10%. If the lower limit of the 2-sided 95% CI was >–10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated ‘effective’ in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 80 participants."|Difference in effective hemostasis (%)|14.3|||||2-Sided|95.0|2.8|25.8||||||The analysis of hemostatic efficacy was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.|
1712615|NCT00803049|3151667|Superiority or Other||Hazard Ratio (HR)|1.02||||0.8763|2-Sided|95.0|0.767|1.357||Threshold for significance at 0.05 level.|Log Rank||Teriflunomide 7 mg/7 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.|
1712616|NCT00803049|3151667|Superiority or Other||Hazard Ratio (HR)|0.79||||0.1866|2-Sided|95.0|0.559|1.117||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 14 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.|
1712617|NCT00803049|3151667|Superiority or Other||Hazard Ratio (HR)|0.961||||0.8017|2-Sided|95.0|0.678|1.362||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 7 mg vs. Teriflunomide 7 mg/7 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.|
1712618|NCT00803049|3151668|Superiority or Other||Hazard Ratio (HR)|0.963||||0.8271|2-Sided|95.0|0.736|1.26||Threshold for significance at 0.05 level.|Log Rank||Teriflunomide 7 mg/7 mg vs. Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.|
1712619|NCT00803049|3151668|Superiority or Other||Hazard Ratio (HR)|0.825||||0.3039|2-Sided|95.0|0.591|1.152||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 14 mg vs.Teriflunomide 14 mg/14 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.|
1712620|NCT00803049|3151668|Superiority or Other||Hazard Ratio (HR)|0.824||||0.2079|2-Sided|95.0|0.602|1.128||Threshold for significance at 0.05 level.|Log Rank||Placebo/Teriflunomide 7 mg vs. Teriflunomide 7 mg/7 mg|Analysis was performed using Log-rank test with treatment, EDSS strata at baseline and region as covariates. Estimation was performed using Cox proportional hazard model with treatment, EDSS strata at baseline and region as covariates.|
1712621|NCT00802997|3151677|Superiority or Other|||||||0.035|||||||t-test, 2 sided||||
1712622|NCT00802841|3151725|Superiority or Other|||||||0.3106|||||||Fisher Exact||||
1712623|NCT00802737|3151738|Superiority or Other||proportion of responders|1.0|||||2-Sided|95.0|0.03|1.0|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.||
1712624|NCT00802737|3151738|Superiority or Other||proportion of responders|0.18|||||2-Sided|95.0|0.02|0.52|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.||
1712625|NCT00802737|3151738|Superiority or Other||proportion of responders|0.24|||||2-Sided|95.0|0.07|0.5|||||Two-sided 95% exact confidence intervals were calculated based on the binomial distribution. The estimated value was calculated using the number of responders (CR+nPR+PR) as the numerator and the total number of par. in the group as the denominator.||
1712626|NCT00802685|3151739|Superiority or Other||Odds Ratio (OR)|0.953||||0.8|2-Sided|95.0|0.393|2.309|||Cochran-Mantel-Haenszel|||null hypothesis: The proportion of subjects on O2 at 36 wk PMA will be equal between treatment arms.|
1712627|NCT00802685|3151740|Superiority or Other||Median Difference (Final Values)|4.0|Standard Deviation|8.0||0.858|2-Sided|95.0|4.0|36.0|||Wilcoxon (Mann-Whitney)|||Null hypothesis: Oxygen duration (days) during the first 28 days will be equal between treatment arms.|
1712657|NCT00800683|3151888|Superiority or Other||Mean Difference (Final Values)|-9.24|Standard Error of the Mean|8.8||0.2954||95.0|-26.67|8.18|||ANCOVA||||
1713859|NCT00790907|3153533|Superiority or Other||Odds Ratio (OR)|0.8||||0.267|2-Sided|95.0|0.54|1.19|||Regression, Logistic||||
1712628|NCT00802672|3151743|Non-Inferiority or Equivalence|For the primary efficacy analysis, a 90% confidence interval was constructed for the difference in the Therapeutic Success rates between the Test Product and Reference Product at Visit 4/Week 6 (Follow-Up). The interval was calculated using Wald’s method with Yates’ continuity correction. Therapeutic equivalence (bioequivalence) was established if this 90% confidence interval was contained within the interval -0.20 to +0.20 (-0.20% to +0.20%)|Mean Difference (Final Values)|1.0|||||2-Sided|90.0|-17.61|2.45|||||||
1712629|NCT00802529|3151751|Superiority or Other|||||||0.128||||||P-value for Drug x Time interaction.|ANOVA|Time: 5 degrees of freedom (Baseline, 1, 2, 6, 12 and 24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)|||
1712630|NCT00802529|3151752|Superiority or Other|||||||0.964||||||P-value for Drug x Time interaction.|ANOVA|Time: 6 degrees of freedom (Baseline, 1, 2, 6, 12, 18 and 24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)|||
1712631|NCT00802529|3151753|Superiority or Other|||||||0.271||||||P-value for Drug x Time interaction.|ANOVA|Time: 2 degrees of freedom (Baseline vs 18-24 months) Drug: 2 degrees of freedom (Gentamicin vs steroid)|||
1712632|NCT00802464|3151779|Other||Fold increase|1.31|||||2-Sided|95.0|1.12|1.54||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.|
1712633|NCT00802464|3151779|Other||Fold increase|2.44|||||2-Sided|95.0|2.02|2.97||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.|
1712634|NCT00802464|3151779|Other||Fold increase|3.21|||||2-Sided|36.0|2.64|3.9||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.|
1712635|NCT00802464|3151780|Other||Fold increase|1.4|||||2-Sided|95.0|1.17|1.68||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 2 Group.|
1712636|NCT00802464|3151780|Other||Fold increase|3.36|||||2-Sided|95.0|2.72|4.17||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 2 Group over GSK1437173A Formulation 3 Group.|
1712637|NCT00802464|3151780|Other||Fold increase|4.72|||||2-Sided|95.0|3.81|5.85||||||Fold increase in anti-gE antibody concentrations for GSK1437173A Formulation 1 Group over GSK1437173A Formulation 3 Group.|
1712638|NCT00802464|3151781|Other||Fold increase|1.3|||||2-Sided|95.0|1.09|1.56||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.|
1712639|NCT00802464|3151781|Other||Fold increase|1.63|||||2-Sided|95.0|1.28|2.07||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.|
1712640|NCT00802464|3151781|Other||Fold increase|2.12|||||2-Sided|95.0|1.67|2.69||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.|
1712641|NCT00802464|3151782|Other||Fold increase|1.3|||||2-Sided|95.0|1.07|1.58||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 2 Group.|
1712642|NCT00802464|3151782|Other||Fold increase|4.02|||||2-Sided|95.0|3.0|5.4||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 2 over GSK1437173A Formulation 3 Group.|
1712643|NCT00802464|3151782|Other||Fold increase|5.21|||||2-Sided|95.0|3.89|6.98||||||Fold increase in frequency of gE-specific CD4+ T-cells secreting at least 2 different immunological activation markers among IFN-γ, IL-2, TNF-α and CD40L for GSK1437173A Formulation 1 over GSK1437173A Formulation 3 Group.|
1712644|NCT00802438|3151783|Other|Summaries of log-transformed data were back-transformed to the original scale and reported as geometric mean with 95% confidence interval or median within 1st and 3rd quartiles. Outcomes are summarized using least squares means with 95% confidence intervals or median with 1st and 3rd quartiles.||||||0.01|||||||t-test, 2 sided||||
1712645|NCT00802438|3151784|Other||||||<|0.0001||||||A two-sided p-value<0.05 was considered significant. Analyses were conducted using SAS version 9.4 (SAS Institute, Cary, NC.).|t-test, 2 sided|||Summaries of log-transformed data were back-transformed to the original scale and reported as geometric mean with 95% confidence interval or median within 1st and 3rd quartiles. Outcomes are summarized using least squares means with 95% confidence intervals or median with 1st and 3rd quartiles.|
1712646|NCT00802412|3151785|Superiority or Other||Hazard Ratio (HR)|1.3||||0.45|2-Sided|95.0|0.66|2.55|||Regression, Cox||||
1712647|NCT00802412|3151785|Superiority or Other||Odds Ratio (OR)|1.6||||0.51|2-Sided|95.0|0.4|6.5|||Regression, Logistic||||
1712648|NCT00802204|3151804|Other||||||<|0.05|||||||t-test, 2 sided|||Paired t-test to compare baseline and post-diet outcome measures|
1712649|NCT00802204|3151804|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|describe.....||Baseline outcome measurements are compared between lean and obese. Baseline and post outcome measurements are compared for the obese who completed VLCD|
1712650|NCT00801983|3151825|Superiority or Other||||||>|0.05|||||||GEE|||Subjects were compared across keyboard types - The percentage of subjects with MSD when using the alternative keyboard were compared to the % of subjects with MSD when they were using the typical keyboard|
1712651|NCT00801684|3151841|Superiority or Other||||||<|0.0001|||||||ANCOVA|||The difference between the active treatment was compared to placebo. For a null hypothesis, the difference would equal 0 (zero).|
1712652|NCT00801632|3151847|Superiority or Other|||||||0.215||||||P-value based on a paired t-test comparing baseline creatinine level with the level at study completion/participant termination.|t-test, 2 sided|The test describes whether the average of the difference is different from zero.|||
1712653|NCT00801632|3151849|Superiority or Other||Percentage of Participants|60.0|||||2-Sided|95.0|14.7|94.7|||||Clopper-Pearson used to derive confidence interval||
1712654|NCT00800683|3151885|Superiority or Other||Mean Difference (Final Values)|1.34|Standard Error of the Mean|8.17||0.8698||95.0|-14.84|17.52|||ANCOVA||||
1712655|NCT00800683|3151886|Superiority or Other||Mean Difference (Final Values)|7.07|Standard Error of the Mean|8.53||0.4085||95.0|-9.82|23.96|||ANCOVA||||
1712658|NCT00800683|3151889|Superiority or Other||Mean Difference (Final Values)|4.42|Standard Error of the Mean|7.92||0.5781||95.0|-11.28|20.12|||ANCOVA||||
1712659|NCT00800683|3151890|Superiority or Other||Mean Difference (Final Values)|-10.72|Standard Error of the Mean|8.09||0.1878||95.0|-26.74|5.31|||ANCOVA||||
1712660|NCT00800683|3151891|Superiority or Other||Mean Difference (Final Values)|-2.24|Standard Error of the Mean|8.19||0.7848||95.0|-18.47|13.98|||ANCOVA||||
1712661|NCT00800683|3151892|Superiority or Other||Mean Difference (Final Values)|-1.73|Standard Error of the Mean|11.43||0.8802||95.0|-24.36|20.91|||ANCOVA||||
1712662|NCT00800683|3151893|Superiority or Other||Odds Ratio (OR)|0.816||||0.8927|2-Sided|95.0|0.042|15.756|||Regression, Logistic|||Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearance|
1712663|NCT00800683|3151894|Superiority or Other||Odds Ratio (OR)|0.103||||0.2225||95.0|0.003|3.978|||Regression, Logistic|||Linagliptin vs Placebo. The odds-ratio is based on a logistic regression model including baseline HbA1c, previous anti-diabetic medication and creatinine clearance|
1712664|NCT00800683|3151895|Superiority or Other|||||||0.1199||||||P−value calculated using a Fisher’s exact Test.|Fisher Exact||||
1712665|NCT00800683|3151896|Superiority or Other||Mean Difference (Final Values)|-0.73|Standard Error of the Mean|0.15|<|0.0001||95.0|-1.02|-0.44|||ANCOVA||||
1712666|NCT00800683|3151897|Superiority or Other||Median Difference (Final Values)|-0.64|Standard Error of the Mean|0.16|<|0.0001||95.0|-0.96|-0.33|||ANCOVA||||
1712667|NCT00800683|3151898|Superiority or Other||Mean Difference (Final Values)|-0.75|Standard Error of the Mean|0.16|<|0.0001||95.0|-1.06|-0.44|||ANCOVA||||
1712668|NCT00800683|3151899|Superiority or Other||Mean Difference (Final Values)|-0.72|Standard Error of the Mean|0.17|<|0.0001||95.0|-1.05|-0.39|||ANCOVA||||
1712669|NCT00800683|3151900|Superiority or Other||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|0.14|<|0.0001||95.0|-0.96|-0.41|||ANCOVA||||
1712670|NCT00800683|3151901|Superiority or Other||Median Difference (Final Values)|-0.61|Standard Error of the Mean|0.14|<|0.0001||95.0|-0.9|-0.33|||ANCOVA||||
1712671|NCT00800683|3151902|Superiority or Other||Mean Difference (Final Values)|-0.72|Standard Error of the Mean|0.16|<|0.0001||95.0|-1.03|-0.41|||ANCOVA||||
1712672|NCT00800683|3151903|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.15|<|0.0001||95.0|-0.89|-0.31|||ANCOVA|||For patients who received rescue medication during the course of the trial, the Oracle Clinical (OC) technique was utilised for all efficacy endpoints and the values were set to missing after the rescue medication was administered.|
1712673|NCT00800254|3151930|Superiority or Other||||||<|0.003|||||||ANCOVA||||
1712674|NCT00800254|3151932|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1712675|NCT00799903|3151940|Superiority||Hazard Ratio (HR)|1.01||||0.87|2-Sided|95.0|0.9|1.13||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox||||
1712676|NCT00799903|3151941|Superiority||Hazard Ratio (HR)|0.96||||0.397|2-Sided|95.0|0.88|1.05||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox||||
1712677|NCT00799903|3151942|Superiority||Hazard Ratio (HR)|1.01||||0.92|2-Sided|95.0|0.81|1.27||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox||||
1712678|NCT00799903|3151943|Superiority||Hazard Ratio (HR)|0.89||||0.108|2-Sided|95.0|0.77|1.03||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox||||
1712679|NCT00799903|3151944|Superiority||Hazard Ratio (HR)|0.96||||0.594|2-Sided|95.0|0.83|1.11||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox||||
1712680|NCT00799903|3151945|Superiority||Hazard Ratio (HR)|0.91||||0.019|2-Sided|95.0|0.84|0.98||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox||||
1712681|NCT00799903|3151946|Superiority||Hazard Ratio (HR)|0.9||||0.045|2-Sided|95.0|0.82|1.0||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox||||
1712682|NCT00799903|3151947|Superiority||Hazard Ratio (HR)|0.94||||0.199|2-Sided|95.1|0.85|1.03||Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio < 1 indicates a lower risk with this treatment compared to Placebo.|Regression, Cox||||
1712683|NCT00799708|3151963|Superiority or Other||Mean Difference (Final Values)|0.38||||0.12|2-Sided|90.0|-0.16|0.92|||ANCOVA||||
1712684|NCT00799708|3151964|Superiority or Other|||||||0.166|||||||ANOVA||||
1712685|NCT00799708|3151964|Superiority or Other|||||||0.345|||||||ANOVA||||
1712686|NCT00799617|3151972|Superiority||Mean Difference (Net)|0.83|||<|0.001|2-Sided|95.0|0.48|1.39||The P-value for the significance of the treatment effect was determined by a linear mixed model for continuous outcomes with a random intercept for participant.|Mixed Models Analysis||Intent-to-treat analysis by a linear mixed effects model adjusted for balancing factors.||
1712687|NCT00799617|3151973|Superiority||Mean Difference (Net)|-5.51||||0.14|2-Sided|95.0|-12.91|1.88||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.|
1713405|NCT00795600|3152759|Superiority or Other||Mean Difference (Final Values)|-1151.0|Standard Error of the Mean|810.48||0.162||95.0|-2780.0|477.33|||ANCOVA||||
1712688|NCT00799617|3151974|Superiority||Mean Difference (Net)|-0.12||||0.89|2-Sided|95.0|-1.89|1.65||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.|
1712689|NCT00799617|3151975|Superiority||Mean Difference (Final Values)|-0.28||||0.24|2-Sided|95.0|-0.76|0.19||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis||The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors.|A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.|
1712690|NCT00799617|3151976|Superiority||Mean Difference (Final Values)|0.56||||0.27|2-Sided|95.0|-0.45|1.58||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear||||
1712691|NCT00799617|3151977|Superiority||Mean Difference (Final Values)|0.07||||0.052|2-Sided|95.0|-0.01|1.36||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear||||
1712692|NCT00799617|3151978|Superiority||Mean Difference (Final Values)|1.2||||0.01|2-Sided|95.0|0.25|2.09||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear||||
1712693|NCT00799617|3151979|Superiority||Mean Difference (Final Values)|1.0|||<|0.001|2-Sided|95.0|0.5|1.4||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear||||
1712694|NCT00799617|3151980|Superiority||Mean Difference (Final Values)|1.0||||0.005|2-Sided|95.0|0.3|1.7||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear||||
1712695|NCT00799617|3151981|Superiority||Mean Difference (Final Values)|1.8|||<|0.001|2-Sided|95.0|1.1|2.6||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear||||
1712696|NCT00799617|3151982|Superiority||Mean Difference (Final Values)|5.7|||<|0.001|2-Sided|95.0|4.3|7.2||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear||||
1712697|NCT00799617|3151983|Superiority||Mean Difference (Final Values)|8.5|||<|0.001|2-Sided|95.0|6.0|10.9||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear||||
1712698|NCT00799617|3151984|Superiority||Mean Difference (Final Values)|7.1|||<|0.001|2-Sided|95.0|5.3|809.0||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear||||
1712699|NCT00799617|3151985|Superiority||Mean Difference (Final Values)|1.3|||<|0.001|2-Sided|95.0|0.8|1.7|||Regression, Linear|||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|
1712700|NCT00799617|3151986|Superiority||Mean Difference (Final Values)|1.0|||<|0.001|2-Sided|95.0|0.5|1.5||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear||||
1712701|NCT00799617|3151987|Superiority||Median Difference (Final Values)|1.5|||<|0.001|2-Sided|95.0|0.9|2.0||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear||||
1712702|NCT00799617|3151988|Superiority||Mean Difference (Final Values)|4.2|||<|0.001|2-Sided|95.0|3.2|5.3||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear||||
1712703|NCT00799617|3151989|Superiority||Mean Difference (Final Values)|2.9|||<|0.001|2-Sided|95.0|2.1|3.7||"Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.~The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors."|Regression, Linear||||
1712704|NCT00799617|3151990|Superiority||Mean Difference (Final Values)|-27.0||||0.31|2-Sided|95.0|-80.0|26.0||Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.||
1712748|NCT00799409|3152058|Superiority or Other||LS Mean Difference|-0.03||||0.0965|2-Sided|95.0|-0.06|0.01||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712705|NCT00799617|3151991|Superiority||Mean Difference (Final Values)|47.0||||0.006|2-Sided|95.0|13.0|80.0||Determined by linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.||
1712706|NCT00799617|3151992|Superiority or Other||Mean Difference (Net)|-0.72||||0.004|2-Sided|95.0|-1.2|-0.23||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Treatment Effect||||
1712707|NCT00799617|3151993|Superiority or Other||Mean Difference (Net)|-0.49|||<|0.001|2-Sided|95.0|-0.79|-0.19||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Treatment Effect||||
1712708|NCT00799617|3151994|Superiority or Other||Mean Difference (Net)|0.47||||0.04|2-Sided|95.0|0.02|0.92||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis||||
1712709|NCT00799617|3151995|Superiority or Other||Mean Difference (Net)|2.41||||0.03|2-Sided|95.0|0.31|4.5||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis||||
1712710|NCT00799617|3151996|Superiority||Mean Difference (Net)|1.21||||0.06|2-Sided|95.0|-0.04|2.46||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis||||
1712711|NCT00799617|3151997|Superiority||Mean Difference (Net)|2.75||||0.03|2-Sided|95.0|0.2|5.29||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis||||
1712712|NCT00799617|3151998|Superiority||Odds Ratio (OR)|1.34||||0.15|2-Sided|95.0|0.9|2.0||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis||||
1712713|NCT00799617|3151999|Superiority||Mean Difference (Final Values)|4.09||||0.28|2-Sided|95.0|-3.0|11.18||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis||||
1712714|NCT00799617|3152000|Superiority||Median Difference (Net)|2.64|||<|0.001|2-Sided|95.0|1.68|3.61||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors|||
1712715|NCT00799617|3152001|Superiority||Mean Difference (Net)|2.93|||<|0.001|2-Sided|95.0|2.13|3.74||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors|||
1712716|NCT00799617|3152002|Superiority|Dichotomous hemoglobin response is an increase of 1g/dL or more from baseline.|Odds Ratio (OR)|31.5||||0.002|2-Sided|95.0|3.7|277.8||The P-value for the significance of the treatment effect was determined by a logistic mixed model with a random intercept for participant.|Mixed Models Analysis|The statistical analysis was intent-to-treat by a logistic mixed effects model adjusted for balancing factors.|||
1712717|NCT00799617|3152003|Superiority||Mean Difference (Net)|-0.07||||0.88|2-Sided|95.0|-0.92|0.79||The estimated difference and P-value were determined by a linear mixed-model with a random effect for participants using outcomes at month 6 and month 12.|Mixed Models Analysis|||"A positive estimated difference indicates greater increases, smaller decreases, or both for the testosterone group compared with the placebo group.~The difference is the mean difference in the change from baseline to 6 months to 12 months in participants allocated to testosterone vs placebo adjusted for balancing factors."|
1712718|NCT00799617|3152004|Superiority||Mean Difference (Final Values)|6.8|||<|0.001|2-Sided|95.0|4.8|8.7||Treatment effect is the mean difference in the change from baseline between testosterone and placebo arms.The P-Value for the significance of the treatment effect was determined by multivariable linear regression adjusted for balancing factors.|Regression, Linear||||
1712719|NCT00799617|3152005|Superiority||Mean Difference (Final Values)|41.0||||0.003|2-Sided|95.0|14.0|67.0||Determined by a linear mixed model with all balancing factors and baseline outcome value as covariates and a random effect for participant.|Regression, Linear||Mean difference in change from baseline for participants assigned to testosterone v. placebo, with adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, PDE5 inhibitors, baseline outcome.||
1712720|NCT00799617|3152006|Superiority||Odds Ratio (OR)|1.23||||0.3|2-Sided|95.0|0.83|1.84||The p value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis||||
1712721|NCT00799617|3152007|Superiority||Odds Ratio (OR)|1.42||||0.2|2-Sided|95.0|0.83|2.45||The P value for the treatment effect was determined with the use of a logistic mixed model with a random effect for participant for dichotomous outcomes and a linear mixed model with a random effect for participant for continuous outcomes.|Mixed Models Analysis|||The treatment effect for dichotomous outcomes is the odds ratio for achieving the outcome versus not achieving the outcome among men assigned to testosterone versus those assigned to placebo.|
1712749|NCT00799409|3152059|Superiority or Other||LS Mean Difference|-0.04||||0.0371|2-Sided|95.0|-0.08|0.0||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712722|NCT00799617|3152008|Superiority||Mean Difference (Net)|0.58|||<|0.001|2-Sided|95.0|0.38|0.78||The p value for the treatment effect was determined with the use of a linear mixed model with a random effect for participant.|Mixed Models Analysis|Adjustment for balancing factors: baseline testosterone, age, site, trial participation, use of antidepressants, use of PDE5 inhibitors|||
1712723|NCT00799487|3152025|Superiority or Other (legacy)||LS Mean Difference|0.03||||0.1368|2-Sided|95.0|-0.01|0.08||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712724|NCT00799487|3152026|Superiority or Other (legacy)||LS Mean Difference|-0.03||||0.1466|2-Sided|95.0|-0.07|0.01||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712725|NCT00799487|3152027|Superiority or Other (legacy)||LS Mean Difference|-0.04||||0.3486|2-Sided|95.0|-0.12|0.04||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712726|NCT00799487|3152028|Superiority or Other (legacy)||LS Mean DIfference|0.0||||0.9729|2-Sided|95.0|-0.09|0.09||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712727|NCT00799487|3152029|Superiority or Other (legacy)||LS Mean Difference|-0.02||||0.4245|2-Sided|95.0|-0.09|0.04||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712728|NCT00799487|3152030|Superiority or Other (legacy)||LS Mean Difference|-0.05||||0.1768|2-Sided|95.0|-0.13|0.02||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712729|NCT00799487|3152031|Superiority or Other (legacy)||LS Mean Difference|-0.07||||0.0051|2-Sided|95.0|-0.12|-0.02||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712730|NCT00799487|3152032|Superiority or Other (legacy)||LS Mean Difference|-0.08||||0.0012|2-Sided|95.0|-0.14|-0.03||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712731|NCT00799487|3152033|Superiority or Other (legacy)||LS Mean Difference|-35.3||||0.004|2-Sided|95.0|-58.89|-11.71||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712732|NCT00799487|3152034|Superiority or Other (legacy)||LS Mean Difference|-0.09||||0.6642|2-Sided|95.0|-0.53|0.34||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712733|NCT00799487|3152035|Superiority or Other (legacy)||LS Mean Difference|-5.38||||0.0101|2-Sided|95.0|-9.43|-1.33||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712734|NCT00799487|3152036|Superiority or Other (legacy)||LS Mean Difference|-3.52||||0.0015|2-Sided|95.0|-5.64|-1.4||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712735|NCT00799487|3152037|Superiority or Other (legacy)||LS Mean Difference|-2.51||||0.2321|2-Sided|95.0|-6.67|1.65||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712736|NCT00799487|3152038|Superiority or Other (legacy)||LS Mean Difference|-0.26||||0.2335|2-Sided|95.0|-0.7|0.17||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712737|NCT00799487|3152039|Superiority or Other (legacy)||LS Mean Difference|-14.37||||0.0002|2-Sided|95.0|-21.52|-7.23||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712738|NCT00799487|3152040|Superiority or Other (legacy)||LS Mean Difference|-0.84||||0.0955|2-Sided|95.0|-1.84|0.15||P-values were determined by using a general linear mixed model. Finger Windows Forwards was the first non-significant p-value in the gatekeeper sequence.|Mixed Models Analysis|Testing of additional endpoints in the sequence was still performed without any unqualified statements about the individual statistical significance.|Placebo minus Concerta||
1712739|NCT00799487|3152041|Superiority or Other (legacy)||LS Mean Difference|-1.13||||0.0297|2-Sided|95.0|-2.15|-0.12||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712740|NCT00799487|3152042|Superiority or Other (legacy)||LS Mean Difference|-30.33|||<|0.0001|2-Sided|95.0|-39.29|-21.37||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712741|NCT00799487|3152043|Superiority or Other (legacy)||LS Mean Difference|-17.58|||<|0.0001|2-Sided|95.0|-23.72|-11.45||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712742|NCT00799487|3152044|Superiority or Other (legacy)||LS Mean Difference|-3.51|||<|0.0001|2-Sided|95.0|-4.27|-2.74||P-values were determined by using a general linear mixed model.|Mixed Models Analysis||Placebo minus Concerta||
1712743|NCT00799487|3152045|Superiority or Other (legacy)||LS Mean Difference|9.5|||<|0.0001|2-Sided|95.0|6.9|12.0||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta||
1712744|NCT00799487|3152046|Superiority or Other (legacy)||LS Mean Difference|4.5|||<|0.0001|2-Sided|95.0|3.2|5.8||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta||
1712745|NCT00799487|3152047|Superiority or Other (legacy)||LS Mean Difference|5.0|||<|0.0001|2-Sided|95.0|3.4|6.6||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta||
1712746|NCT00799487|3152048|Superiority or Other (legacy)||LS Mean Difference|-28.0|||<|0.0001|2-Sided|95.0|-35.1|-20.8||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta||
1712747|NCT00799487|3152049|Superiority or Other (legacy)||LS Mean Difference|-27.3|||<|0.0001|2-Sided|95.0|-34.4|-20.2||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis||Placebo minus Concerta||
1712750|NCT00799409|3152060|Superiority or Other||LS Mean Difference|-0.09||||0.0043|2-Sided|95.0|-0.15|-0.03||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712751|NCT00799409|3152061|Superiority or Other||LS Mean Difference|-0.1||||0.0151|2-Sided|95.0|-0.19|-0.02||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712752|NCT00799409|3152062|Superiority or Other||LS Mean Difference|0.0||||0.998|2-Sided|95.0|-0.08|0.08||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712753|NCT00799409|3152063|Superiority or Other||LS Mean Difference|-0.02||||0.6262|2-Sided|95.0|-0.09|0.05||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712754|NCT00799409|3152064|Superiority or Other||LS Mean Difference|-0.02||||0.4625|2-Sided|95.0|-0.07|0.03||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712755|NCT00799409|3152065|Superiority or Other||LS Mean Difference|-0.08||||0.0002|2-Sided|95.0|-0.13|-0.04||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712756|NCT00799409|3152066|Superiority or Other||LS Mean Difference|-39.55||||0.0002|2-Sided|95.0|-59.7|-19.39||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712757|NCT00799409|3152067|Superiority or Other||LS Mean Difference|-0.02||||0.9195|2-Sided|95.0|-0.37|0.33||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712758|NCT00799409|3152068|Superiority or Other||LS Mean Difference|-5.76||||0.0092|2-Sided|95.0|-10.04|-1.47||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712759|NCT00799409|3152069|Superiority or Other||LS Mean Difference|-4.75||||0.0001|2-Sided|95.0|-6.96|-2.53||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712760|NCT00799409|3152070|Superiority or Other||LS Mean Difference|-6.49||||0.0038|2-Sided|95.0|-10.81|-2.17||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712761|NCT00799409|3152071|Superiority or Other||LS Mean Difference|-0.25||||0.2653|2-Sided|95.0|-0.7|0.2||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712762|NCT00799409|3152072|Superiority or Other||LS Mean Difference|-6.3||||0.1091|2-Sided|95.0|-14.05|1.44||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712763|NCT00799409|3152073|Superiority or Other||LS Mean Difference|-1.32||||0.0057|2-Sided|95.0|-2.25|-0.4||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712764|NCT00799409|3152074|Superiority or Other||LS Mean Difference|-0.93||||0.18|2-Sided|95.0|-1.69|-0.16||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712765|NCT00799409|3152075|Superiority or Other||LS Mean Difference|-22.45|||<|0.0001|2-Sided|95.0|-27.43|-17.47||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712766|NCT00799409|3152076|Superiority or Other||LS Means Difference|-16.03|||<|0.0001|2-Sided|95.0|-19.99|-12.06||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712767|NCT00799409|3152077|Superiority or Other||LS Means Difference|-3.16|||<|0.0001|2-Sided|95.0|-3.72|-2.59||P-Values were determined by using a general linear mixed model.|ANCOVA||Placebo minus CONCERTA||
1712768|NCT00799409|3152078|Superiority or Other||LS Mean Difference|11.0|||<|0.0001|2-Sided|95.0|8.7|13.3||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA||
1712769|NCT00799409|3152079|Superiority or Other||LS Mean Difference|5.1|||<|0.0001|2-Sided|95.0|3.8|6.5||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA||
1712770|NCT00799409|3152080|Superiority or Other||LS Mean Difference|5.9|||<|0.0001|2-Sided|95.0|4.3|7.4||P-Values are determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score.|Mixed Models Analysis|P-Values at each timepoint are determined by using contrast statements in the repeated measures mixed model.|Placebo minus CONCERTA||
1712771|NCT00799409|3152081|Superiority or Other||LS Mean Difference|-28.3|||<|0.0001|2-Sided|95.0|-34.4|-22.2||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score adjusted by Hochberg's step up procedure|Mixed Models Analysis||Placebo minus CONCERTA||
1712772|NCT00799409|3152082|Superiority or Other||LS Mean Difference|-28.6|||<|0.0001|2-Sided|95.0|-35.0|-22.3||P-values were determined by using a repeated measures mixed model with actual value as the dependent variable with terms for treatment, time, treatment by time interaction, period, sequence, and baseline score adjusted by Hochberg's step up procedure|Mixed Models Analysis||Placebo minus CONCERTA||
1712773|NCT00799266|3152098|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|-0.04||||0.5165|2-Sided|95.0|-0.17|0.09|||ANCOVA|||2nd metacarpal cortical width at Month 12|
1712774|NCT00799266|3152099|Other|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.45||||0.9652|2-Sided|0.9652|0.01|999.99||0.45 (<0.01, >999.99)|Regression, Logistic|||Reduction in Pain at Month 12|
1712775|NCT00799266|3152099|Other|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.52||||0.6019|2-Sided|95.0|0.04|6.22|||Regression, Logistic|||Reduction in Pain at Month 9|
1713403|NCT00795600|3152757|Superiority or Other||Mean Difference (Final Values)|-110.4|Standard Error of the Mean|368.69||0.766||95.0|-851.3|630.51|||ANCOVA||||
1712776|NCT00799266|3152099|Other|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|999.99||||0.522|2-Sided|95.0|0.01|999.99||>999.99 (<0.01, >999.99)|Regression, Logistic|||Reduction in Pain at Month 6|
1712777|NCT00799266|3152099|Other|Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.|Odds Ratio (OR)|0.45||||0.5226|2-Sided|95.0|0.04|5.2|||Regression, Logistic|||Reduction in Pain at Month 3|
1712778|NCT00799266|3152100|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|-0.018||||0.318|2-Sided|95.0|-0.055|0.019|||ANCOVA|||Vertebral morphometry at Month 12|
1712779|NCT00799266|3152101|Other|The number and percentage of patients with new vertebral fractures at Month 12 were presented by treatment group and between-treatment differences were evaluated using Fisher’s exact test.||||||0.2258|||||||Fisher Exact|||New vertebral fractures at Month 12|
1712780|NCT00799266|3152102|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|-1.837||||0.184|2-Sided|95.0|-4.103|0.429|||ANCOVA|||Serum TRAP-5b at Month 12|
1712781|NCT00799266|3152102|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|-1.874||||0.2178|2-Sided|95.0|-3.931|0.182|||ANCOVA|||Serum TRAP-5b at Month 6|
1712782|NCT00799266|3152103|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|-27.574||||0.0002|2-Sided|95.0|-39.037|-16.111|||ANCOVA|||Serum NTX at Month 12|
1712783|NCT00799266|3152103|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|-20.938||||0.0254|2-Sided|95.0|-33.766|-8.11|||ANCOVA|||Serum NTX at Month 6|
1712784|NCT00799266|3152104|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|-20.435||||0.0215|2-Sided|95.0|-33.96|-6.909|||ANCOVA|||Serum BSAP at Month 12|
1712785|NCT00799266|3152104|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|-11.223||||0.2129|2-Sided|95.0|-22.595|0.149|||ANCOVA|||Serum BSAP at Month 6|
1712786|NCT00799266|3152105|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|-381.132||||0.0049|2-Sided|95.0|-565.416|-196.848|||ANCOVA|||Serum P1NP at Month 12|
1712787|NCT00799266|3152105|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|-211.782||||0.0631|2-Sided|95.0|-363.765|-59.8|||ANCOVA|||Serum P1NP at Month 6|
1712788|NCT00799266|3152106|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|80.741||||0.2634|2-Sided|95.0|-65.602|227.084|||ANCOVA|||Total Body BMC at Month 12|
1712789|NCT00799266|3152106|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|34.058||||0.3827|2-Sided|95.0|-45.385|113.502|||ANCOVA|||Total Body BMC at Month 6|
1712790|NCT00799266|3152107|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|2.155||||0.234|2-Sided|95.0|-1.488|5.798|||ANCOVA|||Lumbar Spine BMC at Month 12|
1712791|NCT00799266|3152107|Other|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|1.979||||0.0409|2-Sided|95.0|0.089|3.869|||ANCOVA|||Lumbar Spine BMC at Month 6|
1712792|NCT00799266|3152108|Superiority|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|0.29||||0.1322|2-Sided|95.0|-0.094|0.673|||ANCOVA|||Lumbar Spine BMD Z-score at Month 6|
1712793|NCT00799266|3152109|Superiority|Difference in least squares (LS) = LS mean for the zoledronic acid group—LS mean for the placebo group.|Difference in LS mean|0.414||||0.0392|2-Sided|95.0|0.022|0.806|||ANCOVA|||Lumbar Spine BMD Z-score at Month 12|
1712794|NCT00798967|3152114|Superiority or Other||||||<|0.001|||||||ANCOVA|||Last Dosing Visit|
1712795|NCT00798967|3152115|Superiority or Other|||||||0.002||||||Cochran-Mantel-Haenszel (CMH) test adjusted for the randomization stratification variable (<= 6 or > 6 L/week of PN at baseline)|Cochran-Mantel-Haenszel||||
1712796|NCT00798707|3152123|Superiority or Other|||||||0.72|||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).|
1712797|NCT00798707|3152123|Superiority or Other|||||||0.72|||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 10 (or ET + 2 weeks).|
1712798|NCT00798707|3152123|Superiority or Other|||||||0.72|||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).|
1712799|NCT00798707|3152123|Superiority or Other|||||||0.72|||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 9 (or ET + 1 week).|
1712800|NCT00798707|3152123|Superiority or Other|||||||0.847|||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).|
1712801|NCT00798707|3152123|Superiority or Other|||||||0.847|||||||t-test, 2 sided|||To address the multiplicity effect inherent in these comparisons, adjusted p-values based on the false discovery rate were used at Week 8 (or ET).|
1712802|NCT00798707|3152125|Superiority or Other||Odds Ratio (OR)|1.165||||0.6397|2-Sided|95.0|0.61|2.21|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.|
1712803|NCT00798707|3152125|Superiority or Other||Odds Ratio (OR)|0.951||||0.8758|2-Sided|95.0|0.51|1.78|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment and gender as factors and baseline sexual dysfunction status as a covariate.|
1713754|NCT00791921|3153259|Superiority or Other||||||<|0.05|||||||Regression, Logistic||||
1712804|NCT00798707|3152126|Superiority or Other||Mean Difference (Final Values)|-0.63||||0.15|2-Sided|95.0|-1.48|0.23|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1712805|NCT00798707|3152126|Superiority or Other||Mean Difference (Final Values)|-0.81||||0.066|2-Sided|95.0|-1.67|0.05|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1712806|NCT00798707|3152127|Superiority or Other||Mean Difference (Final Values)|0.43||||0.689|2-Sided|95.0|-1.76|2.62|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score|
1712807|NCT00798707|3152127|Superiority or Other||Mean Difference (Final Values)|1.29||||0.538|2-Sided|95.0|-2.98|5.57|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for family life/home responsibilities component score.|
1712808|NCT00798707|3152127|Superiority or Other||Mean Difference (Final Values)|0.35||||0.104|2-Sided|95.0|-0.07|0.78|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.|
1712809|NCT00798707|3152127|Superiority or Other||Mean Difference (Final Values)|0.41||||0.064|2-Sided|95.0|-0.02|0.84|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for social life component score.|
1712810|NCT00798707|3152127|Superiority or Other||Mean Difference (Final Values)|0.35||||0.109|2-Sided|95.0|-0.08|0.77|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.|
1712811|NCT00798707|3152127|Superiority or Other||Mean Difference (Final Values)|0.3||||0.176|2-Sided|95.0|-0.13|0.73|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for work/studies component score.|
1712812|NCT00798707|3152127|Superiority or Other||Median Difference (Final Values)|1.06||||0.078|2-Sided|95.0|-0.12|2.24|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.|
1712813|NCT00798707|3152127|Superiority or Other||Mean Difference (Final Values)|1.09||||0.073|2-Sided|95.0|-0.1|2.29|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate for total score.|
1712814|NCT00798707|3152129|Superiority or Other||Odds Ratio (OR)|1.372||||0.0888|2-Sided|95.0|0.95|1.97|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor.|
1712815|NCT00798707|3152129|Superiority or Other||Odds Ratio (OR)|1.158||||0.4313|2-Sided|95.0|0.8|1.67|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor.|
1712816|NCT00798707|3152130|Superiority or Other||Odds Ratio (OR)|1.827||||0.0022|2-Sided|95.0|1.24|2.69|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.|
1712817|NCT00798707|3152130|Superiority or Other||Odds Ratio (OR)|1.277||||0.2232|2-Sided|95.0|0.86|1.89|||Regression, Logistic|||Analysis was conducted with a logistic regression model with treatment as a factor and baseline MADRS score as a covariate.|
1712818|NCT00798707|3152131|Superiority or Other||Odds Ratio (OR)|1.474||||0.0852|2-Sided|95.0|0.95|2.29|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.|
1712819|NCT00798707|3152131|Superiority or Other||Odds Ratio (OR)|0.878||||0.5929|2-Sided|95.0|0.54|1.41|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.|
1712820|NCT00798707|3152132|Superiority or Other||Odds Ratio (OR)|1.591||||0.0154|2-Sided|95.0|1.09|2.32|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.|
1712821|NCT00798707|3152132|Superiority or Other||Odds Ratio (OR)|1.363||||0.1099|2-Sided|95.0|0.93|1.99|||Regression, Logistic|||Analysis was conducted using a logistic regression model with treatment as a factor and baseline HAM-D17 score as a covariate.|
1712822|NCT00798707|3152133|Superiority or Other||Median Difference (Final Values)|0.72||||0.048|2-Sided|95.0|0.01|1.43|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1712823|NCT00798707|3152133|Superiority or Other||Mean Difference (Final Values)|0.09||||0.802|2-Sided|95.0|-0.62|0.8|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1712824|NCT00798707|3152134|Superiority or Other||Mean Difference (Final Values)|2.06||||0.016|2-Sided|95.0|0.39|3.73|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1712825|NCT00798707|3152134|Superiority or Other||Mean Difference (Final Values)|1.0||||0.242|2-Sided|95.0|-0.68|2.68|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1712826|NCT00798707|3152135|Superiority or Other||Mean Difference (Final Values)|0.21||||0.038|2-Sided|95.0|0.01|0.41|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1712827|NCT00798707|3152135|Superiority or Other||Mean Difference (Final Values)|0.19||||0.066|2-Sided|95.0|-0.01|0.39|||ANCOVA|||Analysis was conducted using ANCOVA on the change from baseline with treatment as a factor and corresponding baseline value as a covariate.|
1712848|NCT00798434|3152186|Superiority or Other||Mean Difference (Final Values)|5.39|Standard Error of the Mean|1.44|<|0.0002|2-Sided|95.0|2.57|8.22|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Coping Subscale at Week 12; LOCF|
1712876|NCT00798161|3152231|Superiority or Other||Mean Difference (Final Values)|-50.8|Standard Error of the Mean|23.8||0.0373||95.0|-98.5|-3.1|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712828|NCT00798707|3152136|Superiority or Other|||||||0.028||||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure.p-Value obtained for the alternative hypothesis of `Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.|
1712829|NCT00798707|3152136|Superiority or Other|||||||0.16||||||In this case, multiplicity arising from testing key secondary hypotheses in both doses was controlled by a Hochberg step-up procedure. p-Value obtained for the alternative hypothesis of `Row mean scores differences'.|Cochran-Mantel-Haenszel|||Each DVS SR dose was separately compared to placebo. To control the study-wise type I error rate across the primary and the key secondary endpoints, as well as across the 2 active dose arms, testing of the key secondary hypothesis occurred only when both active doses were superior to placebo on the primary endpoint.|
1712830|NCT00798707|3152137|Superiority or Other||Mean Difference (Final Values)|1.5||||0.016|2-Sided|95.0|0.28|2.72||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.|
1712831|NCT00798707|3152137|Superiority or Other||Mean Difference (Final Values)|0.47||||0.452|2-Sided|95.0|-0.75|1.69||A Hochberg step-up procedure was used to control for the multiplicity associated with multiple active dose arms.|ANCOVA|||An analysis of covariance (ANCOVA) model with treatment and as a factor and the baseline HAM-D17 total score as a covariate was used to compare each DVS SR dose to placebo. The comparison was performed at the 0.05 level overall.|
1712832|NCT00798694|3152143|Superiority|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||"Null Hypothesis: There is no significant difference in tear break-up time between the group New to Meds and the group Currently on Xalatan at two months."|
1712833|NCT00798434|3152182|Superiority or Other||Mean Difference (Final Values)|0.0016|Standard Error of the Mean|0.0125||0.8959|2-Sided|95.0|-0.0229|0.0262|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline single utility score|||
1712834|NCT00798434|3152183|Superiority or Other||Mean Difference (Final Values)|-10.19|Standard Error of the Mean|5.12||0.0532|2-Sided|95.0|-20.53|0.15|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Severity of Urinary Symptoms; LOCF|
1712835|NCT00798434|3152183|Superiority or Other||Mean Difference (Final Values)|4.46|Standard Error of the Mean|6.82||0.5167|2-Sided|95.0|-9.3|18.23|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Sleep/Energy; LOCF|
1712836|NCT00798434|3152183|Superiority or Other||Mean Difference (Final Values)|-6.07|Standard Error of the Mean|6.88||0.3831|2-Sided|95.0|-19.96|7.83|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Emotions; LOCF|
1712837|NCT00798434|3152183|Superiority or Other||Mean Difference (Final Values)|-11.11|Standard Error of the Mean|8.38||0.2013|2-Sided|95.0|-28.71|6.49|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Personal Relationships; LOCF|
1712838|NCT00798434|3152183|Superiority or Other||Mean Difference (Final Values)|3.26|Standard Error of the Mean|6.8||0.6344|2-Sided|95.0|-10.47|16.99|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Social Limitations; LOCF|
1712839|NCT00798434|3152183|Superiority or Other||Mean Difference (Final Values)|-3.81|Standard Error of the Mean|8.39||0.6523|2-Sided|95.0|-20.74|13.12|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Physical Limitations; LOCF|
1712840|NCT00798434|3152183|Superiority or Other||Mean Difference (Final Values)|-5.85|Standard Error of the Mean|9.28||0.5321|2-Sided|95.0|-24.58|12.88|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Role Limitations; LOCF|
1712841|NCT00798434|3152183|Superiority or Other||Mean Difference (Final Values)|-6.29|Standard Error of the Mean|8.63||0.4698|2-Sided|95.0|-23.7|11.11|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||Incontinence Impact; LOCF|
1712842|NCT00798434|3152183|Superiority or Other||Mean Difference (Final Values)|4.18|Standard Error of the Mean|4.12||0.3163|2-Sided|95.0|-4.13|12.49|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total domain score||General Health Perception; LOCF|
1712843|NCT00798434|3152184|Superiority or Other||Odds Ratio (OR)|2.881|||<|0.0001|2-Sided|95.0|2.045|4.058||Analysis determined the odds of responding on the OAB-S scale (OAB medication expectation) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.|Regression, Logistic|Covariates were treatment, study center, dosing time and age category||LOCF|
1712844|NCT00798434|3152185|Superiority or Other||Odds Ratio (OR)|3.537|||<|0.001|2-Sided|95.0|2.281|5.484||Analysis determined the odds of responding on the OAB-S scale (satisfaction with OAB control) for Fesoterodine versus placebo, where a responder was defined as a response of 'satisfied' or better on all 7 questions at week 12.|Regression, Logistic|Covariates were treatment, study center, dosing time and age category||LOCF|
1712845|NCT00798434|3152186|Superiority or Other||Mean Difference (Final Values)|2.51|Standard Error of the Mean|1.03||0.0152|2-Sided|95.0|0.49|4.53|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Social Subscale at Week 12; LOCF|
1712846|NCT00798434|3152186|Superiority or Other||Mean Difference (Final Values)|4.09|Standard Error of the Mean|1.38||0.0032|2-Sided|95.0|1.38|6.81|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Sleep Subscale at Week 12; LOCF|
1712847|NCT00798434|3152186|Superiority or Other||Mean Difference (Final Values)|5.39|Standard Error of the Mean|1.29|<|0.0001|2-Sided|95.0|2.84|7.93|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline HRQL subscale score||Concern Subscale at Week 12; LOCF|
1712875|NCT00798161|3152231|Superiority or Other||Mean Difference (Final Values)|-73.9|Standard Error of the Mean|22.7||0.0018||95.0|-119.3|-28.6|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712849|NCT00798434|3152187|Superiority or Other||Mean Difference (Final Values)|4.48|Standard Error of the Mean|1.14|<|0.0001|2-Sided|95.0|2.24|6.73|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline total health-related quality of life (HRQL) score.||Week 12 LOCF|
1712850|NCT00798434|3152188|Superiority or Other||Mean Difference (Final Values)|-7.12|Standard Error of the Mean|1.29|<|0.0001|2-Sided|95.0|-9.65|-4.59|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline symptom/bother score||Week 12 LOCF|
1712851|NCT00798434|3152190|Superiority or Other||Odds Ratio (OR)|1.916||||0.0009|2-Sided|95.0|1.305|2.811||Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as an increase of 1 or more points in difference of scores relative to baseline.|Regression, Logistic|Covariates were treatment, study center, dosing time, age category, and baseline PPUS category||LOCF|
1712852|NCT00798434|3152194|Superiority or Other||Odds Ratio (OR)|2.506|||<|0.0001|2-Sided|95.0|1.767|3.556||Logistic regression determined the odds of improvement versus no improvement in PPBC score, where improvement was defined as a negative change from baseline.|Regression, Logistic|Covariates were treatment, study center, dosing time, age category, and baseline PPBC category||Week 12 LOCF|
1712853|NCT00798434|3152197|Superiority or Other||Odds Ratio (OR)|3.096|||<|0.0001|2-Sided|95.0|2.181|4.395|||Regression, Logistic|Covariates were treatment, study center, dosing time, and age category||Week 12 LOCF|
1712854|NCT00798434|3152198|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.03||0.2039|2-Sided|95.0|-0.08|0.02|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of powders per 24 hours||Powder at Week 12 LOCF|
1712855|NCT00798434|3152198|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.03||0.0909|2-Sided|95.0|-0.12|0.01|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of creams per 24 hours||Creams at Week 12 LOCF|
1712856|NCT00798434|3152198|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.11||0.023|2-Sided|95.0|-0.47|-0.04|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of pads per 24 hours||Incontinence pads at Week 12 LOCF|
1712857|NCT00798434|3152199|Superiority or Other||Odds Ratio (OR)|1.515||||0.1113|2-Sided|95.0|0.909|2.528||Logistic regression determined the odds of improvement versus no improvement in dryness, where improvement was defined as dry at both weeks 8 and 12 relative to baseline incontinence.|Regression, Logistic|Covariates were treatment, study center, dosing time, and age category||LOCF|
1712858|NCT00798434|3152200|Superiority or Other||Mean Difference (Final Values)|-4.7|Standard Error of the Mean|0.81|<|0.0001|2-Sided|95.0|-6.3|-3.1|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and daily sum rating of USS at baseline||Week 12 LOCF|
1712859|NCT00798434|3152201|Superiority or Other||Median Difference (Final Values)|0.0||||0.0218|2-Sided|95.0|0.0|0.0|||2-sided Van Elteren's test|||Week 12 LOCF|
1712860|NCT00798434|3152202|Superiority or Other||Hodges-Lehman estimate|0.0||||0.1005|2-Sided|95.0|0.0|0.0||The protocol-defined analysis (ANOVA, parametric) not presented because normality assumptions were not met, instead an alternative analysis (Van-Elteren'ts test, non-parametric) as defined in the statistical analysis plan presented.|Van-Elteren's Test||Hodges-Lehman estimate of median treatment difference and CI|Week 12 LOCF|
1712861|NCT00798434|3152203|Superiority or Other||Median Difference (Final Values)|-9.52||||0.0012|2-Sided|95.0|-9.52|-9.09|||2-sided Van Elteren's test|||Week 12 LOCF|
1712862|NCT00798434|3152204|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.08||0.0026|2-Sided|95.0|-0.4|-0.09|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of night-time micturitions||Week 12 LOCF|
1712863|NCT00798434|3152205|Superiority or Other||Median Difference (Final Values)|-7.31|||<|0.0001|2-Sided|95.0|-7.4|-7.19|||2-sided Van Elteren's test|||Week 12 LOCF|
1712864|NCT00798434|3152206|Superiority or Other||Mean Difference (Final Values)|-0.98|Standard Error of the Mean|0.18|<|0.0001|2-Sided|95.0|-1.33|-0.64|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline number of micturitions||Week 12 LOCF|
1712865|NCT00798434|3152207|Superiority or Other||Median Difference (Final Values)|0.0||||0.0005|2-Sided|95.0|0.0|0.0|||2-sided Van Elteren's test||Hodges-Lehman estimate of median treatment difference and CI|Week 12 LOCF|
1712866|NCT00798434|3152208|Superiority or Other||Mean Difference (Final Values)|-0.85|Standard Error of the Mean|0.22||0.0001|2-Sided|95.0|-1.28|-0.42|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline severe urgency episodes||Week 12 LOCF|
1712867|NCT00798434|3152209|Superiority or Other||Median Difference (Final Values)|-14.44|||<|0.0001|2-Sided|95.0|-14.67|-14.25|||2-sided Van Elteren's test||Hodges-Lehman estimate of median treatment difference and confidence interval (CI)|Week 12 LOCF|
1712868|NCT00798434|3152210|Superiority or Other||Mean Difference (Final Values)|-1.54|Standard Error of the Mean|0.29|<|0.0001|2-Sided|95.0|-2.12|-0.97|||ANCOVA|Covariates were treatment, study center, dosing time, age category, and baseline urgency episodes.||Based on a 2-sided t-test (5% significance). Null hypothesis: no difference in mean change in mean micturition-related urgency episodes per 24 hours at Week 12 for the 2 groups. Last observation carried forward (LOCF) method used for statistical analyses of the FAS (change from baseline to Week 12).|
1712869|NCT00798317|3152219|Superiority or Other||Odds Ratio (OR)|5.13|||<|0.001|2-Sided|95.0|1.97|17.0||Comparing placebo and ocriplasmin|Fisher Exact||||
1712870|NCT00798174|3152227|Superiority|The null hypothesis was that the azygos coil does not reduce the DFT. (A reduced DFT is superiority).||||||0.103||||||Threshold for significance is 0.05.|t-test, 2 sided|Paired t-test||"The null hypothesis is that there is no difference between the DFT using the azygos coil vs. the standard configuration.~Paired t-test (two-tailed), used due to construction of study with DFT determined in both configurations in each patient, yields p=0.103"|
1712871|NCT00798161|3152228|Superiority or Other||Odds Ratio (OR)|0.598||||0.2617|2-Sided|95.0|0.244|1.467|||Regression, Logistic||||
1712872|NCT00798161|3152228|Superiority or Other||Odds Ratio (OR)|0.42||||0.049|2-Sided|95.0|0.177|0.996|||Regression, Logistic||||
1712873|NCT00798161|3152228|Superiority or Other||Odds Ratio (OR)|0.274||||0.0151|2-Sided|95.0|0.096|0.779|||Regression, Logistic||||
1712874|NCT00798161|3152228|Superiority or Other||Odds Ratio (OR)|0.326||||0.0445|2-Sided|95.0|0.109|0.973|||Regression, Logistic||||
1712877|NCT00798161|3152231|Superiority or Other||Mean Difference (Final Values)|-22.0|Standard Error of the Mean|22.1||0.3234||95.0|-66.2|22.2|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712878|NCT00798161|3152231|Superiority or Other||Mean Difference (Final Values)|-3.2|Standard Error of the Mean|22.7||0.8893||95.0|-48.5|42.2|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712879|NCT00798161|3152232|Superiority or Other||Odds Ratio (OR)|6.529|||<|0.0001||95.0|3.724|11.445|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712880|NCT00798161|3152232|Superiority or Other||Odds Ratio (OR)|3.622|||<|0.0001||95.0|2.153|6.093|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712881|NCT00798161|3152232|Superiority or Other||Odds Ratio (OR)|2.382|||<|0.0027||95.0|1.352|4.196|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712882|NCT00798161|3152232|Superiority or Other||Odds Ratio (OR)|3.181|||<|0.0001||95.0|1.903|5.316|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712883|NCT00798161|3152234|Superiority or Other||Odds Ratio (OR)|11.947|||<|0.0001||95.0|4.314|33.08|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712884|NCT00798161|3152234|Superiority or Other||Odds Ratio (OR)|4.521|||<|0.0053||95.0|1.564|13.069|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712885|NCT00798161|3152234|Superiority or Other||Odds Ratio (OR)|3.521|||<|0.0004||95.0|1.747|7.094|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712886|NCT00798161|3152234|Superiority or Other||Odds Ratio (OR)|3.465|||<|0.0102||95.0|1.342|8.943|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712887|NCT00798161|3152236|Superiority or Other||Odds Ratio (OR)|17.094|||<|0.0001||95.0|8.238|35.471|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712888|NCT00798161|3152236|Superiority or Other||Odds Ratio (OR)|4.854|||<|0.0001||95.0|2.363|9.973|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712889|NCT00798161|3152236|Superiority or Other||Odds Ratio (OR)|4.163|||<|0.0001||95.0|2.343|7.397|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712890|NCT00798161|3152236|Superiority or Other||Odds Ratio (OR)|2.372|||<|0.0062||95.0|1.278|4.402|||Regression, Logistic|The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication.||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712891|NCT00798161|3152237|Superiority or Other||Mean Difference (Final Values)|-39.0|Standard Error of the Mean|4.9|<|0.0001||95.0|-48.5|-29.4|||ANCOVA|||Linagliptin 5 mg vs. Linagliptin 2.5 mg with Metformin 1000 mg|
1712892|NCT00798161|3152237|Superiority or Other||Mean Difference (Final Values)|-25.4|Standard Error of the Mean|4.9|<|0.0001||95.0|-35.0|-15.9|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712893|NCT00798161|3152237|Superiority or Other||Mean Difference (Final Values)|-17.9|Standard Error of the Mean|4.9|<|0.0003||95.0|-27.4|-8.3|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712894|NCT00798161|3152237|Superiority or Other||Mean Difference (Final Values)|-20.9|Standard Error of the Mean|4.8|<|0.0001||95.0|-30.4|-11.4|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712895|NCT00798161|3152238|Superiority or Other||Mean Difference (Final Values)|-41.5|Standard Error of the Mean|4.7|<|0.0001||95.0|-50.8|-32.2|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712896|NCT00798161|3152238|Superiority or Other||Mean Difference (Final Values)|-27.8|Standard Error of the Mean|4.7|<|0.0001||95.0|-37.1|-18.5|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712897|NCT00798161|3152238|Superiority or Other||Mean Difference (Final Values)|-18.0|Standard Error of the Mean|4.8|<|0.0002||95.0|-27.4|-8.7|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712898|NCT00798161|3152238|Superiority or Other||Mean Difference (Final Values)|-14.4|Standard Error of the Mean|4.7|<|0.0024||95.0|-23.7|-5.1|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712899|NCT00798161|3152239|Superiority or Other||Mean Difference (Final Values)|-37.6|Standard Error of the Mean|4.5|<|0.0001||95.0|-46.4|-28.8|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712900|NCT00798161|3152239|Superiority or Other||Mean Difference (Final Values)|-27.9|Standard Error of the Mean|4.5|<|0.0001||95.0|-36.7|-19.1|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712901|NCT00798161|3152239|Superiority or Other||Mean Difference (Final Values)|-16.8|Standard Error of the Mean|4.5|<|0.0002||95.0|-25.6|-7.9|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712902|NCT00798161|3152239|Superiority or Other||Mean Difference (Final Values)|-17.9|Standard Error of the Mean|4.5|<|0.0001||95.0|-26.7|-9.1|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712903|NCT00798161|3152240|Superiority or Other||Mean Difference (Final Values)|-25.6|Standard Error of the Mean|4.1|<|0.0001||95.0|-33.6|-17.6|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712904|NCT00798161|3152240|Superiority or Other||Mean Difference (Final Values)|-21.5|Standard Error of the Mean|4.1|<|0.0001||95.0|-29.5|-13.4|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712905|NCT00798161|3152240|Superiority or Other||Mean Difference (Final Values)|-16.8|Standard Error of the Mean|4.1|<|0.0001||95.0|-24.9|-8.8|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712906|NCT00798161|3152240|Superiority or Other||Mean Difference (Final Values)|-14.9|Standard Error of the Mean|4.1|<|0.0003||95.0|-22.9|-6.8|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712907|NCT00798161|3152241|Superiority or Other||Mean Difference (Final Values)|-40.8|Standard Error of the Mean|5.0|<|0.0001||95.0|-50.6|-31.0|||ANCOVA|||Linagliptin 5mg vs. linagliptin 2.5mg with metformin 1000mg|
1712908|NCT00798161|3152241|Superiority or Other||Mean Difference (Final Values)|-24.6|Standard Error of the Mean|5.0|<|0.0001||95.0|-34.4|-14.8|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712909|NCT00798161|3152241|Superiority or Other||Mean Difference (Final Values)|-17.2|Standard Error of the Mean|5.0|<|0.0006||95.0|-27.1|-7.3|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712910|NCT00798161|3152241|Superiority or Other||Mean Difference (Final Values)|-17.4|Standard Error of the Mean|5.0|<|0.0005||95.0|-27.2|-7.6|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712911|NCT00798161|3152242|Superiority or Other||Mean Difference (Final Values)|-1.08|Standard Error of the Mean|0.11|<|0.0001||95.0|-1.3|-0.86|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712912|NCT00798161|3152242|Superiority or Other||Mean Difference (Final Values)|-0.72|Standard Error of the Mean|0.11|<|0.0001||95.0|-0.94|-0.49|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712913|NCT00798161|3152242|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.11|<|0.0001||95.0|-0.69|-0.26|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712914|NCT00798161|3152242|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.11|<|0.0001||95.0|-0.73|-0.29|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712915|NCT00798161|3152243|Superiority or Other||Mean Difference (Final Values)|-0.95|Standard Error of the Mean|0.1|<|0.0001||95.0|-1.16|-0.75|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712916|NCT00798161|3152243|Superiority or Other||Mean Difference (Final Values)|-0.71|Standard Error of the Mean|0.11|<|0.0001||95.0|-0.92|-0.51|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712917|NCT00798161|3152243|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.63|-0.22|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712918|NCT00798161|3152243|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.72|-0.31|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712919|NCT00798161|3152244|Superiority or Other||Mean Difference (Final Values)|-0.64|Standard Error of the Mean|0.08|<|0.0001||95.0|-0.79|-0.48|||ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712920|NCT00798161|3152244|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.08|<|0.0001||95.0|-0.65|-0.35|||ANCOVA|||Linagliptin 5mg vs Linagliptin 2.5mg with metformin 500mg|
1712921|NCT00798161|3152244|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.08|<|0.0001||95.0|-0.53|-0.23|||ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712922|NCT00798161|3152244|Superiority or Other||Mean Difference (Final Values)|-0.41|Standard Error of the Mean|0.08|<|0.0001||95.0|-0.56|-0.26|||ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712923|NCT00798161|3152245|Superiority or Other||Mean Difference (Final Values)|-1.14|Standard Error of the Mean|0.11|<|0.0001||95.0|-1.36|-0.92||hierarchical testing, no adjustment of p-values|ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712924|NCT00798161|3152245|Superiority or Other||Mean Difference (Final Values)|-0.77|Standard Error of the Mean|0.11|<|0.0001||95.0|-0.99|-0.55||hierarchical testing, no adjustment of p-values|ANCOVA|||Linagliptin 5mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712925|NCT00798161|3152245|Superiority or Other||Median Difference (Final Values)|-0.51|Standard Error of the Mean|0.11|<|0.0001||95.0|-0.73|-0.3||hierarchical testing, no adjustment of p-values|ANCOVA|||Metformin 1000mg vs. Linagliptin 2.5mg with Metformin 1000mg|
1712926|NCT00798161|3152245|Superiority or Other||Mean Difference (Final Values)|-0.58|Standard Error of the Mean|0.11|<|0.0001||95.0|-0.79|-0.36||hierarchical testing, no adjustment of p-values|ANCOVA|||Metformin 500mg vs. Linagliptin 2.5mg with Metformin 500mg|
1712927|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|1.28||||0.0662|2-Sided|95.0|0.98|1.67||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.|
1712928|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|0.9||||0.4903|2-Sided|95.0|0.66|1.22||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.|
1712929|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|0.89||||0.5111|2-Sided|95.0|0.63|1.26||Cochran-Mantel-Haenszel general association test controlling for study center.|Chi-squared, Corrected|||Week 14 values presented here.|
1712930|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|1.47||||0.0118|2-Sided|95.0|1.09|1.98||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.|
1712931|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|1.13||||0.4435|2-Sided|95.0|0.83|1.56||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.|
1712932|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|1.09||||0.6611|2-Sided|95.0|0.74|1.61||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.|
1712933|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|1.34||||0.0832|2-Sided|95.0|0.97|1.86||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.|
1712934|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|1.06||||0.7469|2-Sided|95.0|0.74|1.52||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.|
1712935|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|1.09||||0.7064|2-Sided|95.0|0.72|1.63||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.|
1712936|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|1.17||||0.3837|2-Sided|95.0|0.83|1.64||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.|
1712937|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|1.03||||0.8945|2-Sided|95.0|0.71|1.49||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.|
1712938|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|1.06||||0.8007|2-Sided|95.0|0.69|1.61||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.|
1712939|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|0.88||||0.553|2-Sided|95.0|0.59|1.32||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.|
1712940|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|0.68||||0.093|2-Sided|95.0|0.43|1.08||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.|
1712941|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|0.95||||0.8323|2-Sided|95.0|0.59|1.53||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.|
1712942|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|0.93||||0.8118|2-Sided|95.0|0.53|1.63||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.|
1712943|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|0.8||||0.4971|2-Sided|95.0|0.43|1.49||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.|
1712944|NCT00797966|3152254|Superiority or Other||Ratio of Response Rate|0.98||||0.9462|2-Sided|95.0|0.52|1.84||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.|
1712945|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|1.7||||0.0525|2-Sided|95.0|0.98|2.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.|
1712946|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|1.13||||0.667|2-Sided|95.0|0.65|1.99||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.|
1712947|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|1.62||||0.1254|2-Sided|95.0|0.87|3.02||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.|
1712948|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|0.99||||0.9602|2-Sided|95.0|0.55|1.76||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.|
1712949|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|1.16||||0.5846|2-Sided|95.0|0.69|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.|
1712950|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|1.24||||0.4997|2-Sided|95.0|0.65|2.34||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.|
1712951|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|1.77||||0.0522|2-Sided|95.0|0.98|3.17||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.|
1712952|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|0.96||||0.9115|2-Sided|95.0|0.49|1.88||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.|
1712953|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|1.82||||0.084|2-Sided|95.0|0.93|3.58||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.|
1712954|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|1.19||||0.5898|2-Sided|95.0|0.64|2.24|||Cochran-Mantel-Haenszel|||Week 11 values presented here.|
1712955|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|0.96||||0.9035|2-Sided|95.0|0.52|1.77||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.|
1712956|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|1.06||||0.8807|2-Sided|95.0|0.51|2.2||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.|
1712957|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|1.07||||0.8615|2-Sided|95.0|0.53|2.15||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.|
1712958|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|0.61||||0.2339|2-Sided|95.0|0.28|1.35||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.|
1712959|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|0.83||||0.6986|2-Sided|95.0|0.32|2.18||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.|
1712960|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|0.39||||0.2259|2-Sided|95.0|0.08|1.87||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.|
1712961|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|0.43||||0.2653|2-Sided|95.0|0.1|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.|
1712962|NCT00797966|3152255|Superiority or Other||Ratio of Remission Rate|0.59||||0.5791|2-Sided|95.0|0.09|3.9||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.|
1712963|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|1.74||||0.008|2-Sided|95.0|1.14|2.65||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.|
1714821|NCT00778258|3155387|Superiority or Other|||||||0.077||||||Correlation = -0.27|Spearman Correlation|||Month 36 Comparison|
1712964|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|1.02||||0.9463|2-Sided|95.0|0.64|1.62||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.|
1712965|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|1.29||||0.3254|2-Sided|95.0|0.79|2.12||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.|
1712966|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|1.39||||0.1614|2-Sided|95.0|0.86|2.25||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.|
1712967|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|1.27||||0.299|2-Sided|95.0|0.81|2.0||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.|
1712968|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|1.27||||0.3968|2-Sided|95.0|0.72|2.23||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.|
1712969|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|2.02||||0.0063|2-Sided|95.0|1.2|3.41||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.|
1712970|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|1.27||||0.4358|2-Sided|95.0|0.7|2.31||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.|
1712971|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|2.35||||0.0035|2-Sided|95.0|1.32|4.18||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.|
1712972|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|1.31||||0.3135|2-Sided|95.0|0.78|2.21||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.|
1712973|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|1.14||||0.6375|2-Sided|95.0|0.67|1.94||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.|
1712974|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|1.35||||0.3441|2-Sided|95.0|0.74|2.44||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.|
1712975|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|1.06||||0.869|2-Sided|95.0|0.54|2.1||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.|
1712976|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|0.92||||0.8264|2-Sided|95.0|0.46|1.85||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.|
1712977|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|0.78||||0.6051|2-Sided|95.0|0.3|2.05||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.|
1712978|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|0.32||||0.0553|2-Sided|95.0|0.1|1.07||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.|
1712979|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|0.94||||0.8812|2-Sided|95.0|0.42|2.1||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.|
1712980|NCT00797966|3152256|Superiority or Other||Ratio of Response Rate|0.49||||0.3007|2-Sided|95.0|0.12|1.93||Cochran-Mantel-Haenszel general association test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.|
1712981|NCT00797966|3152257|Superiority or Other|||||||0.0183||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.|
1712982|NCT00797966|3152257|Superiority or Other|||||||0.6741||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.|
1712983|NCT00797966|3152257|Superiority or Other|||||||0.8441||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 14 values presented here.|
1712984|NCT00797966|3152257|Superiority or Other|||||||0.0672||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.|
1712985|NCT00797966|3152257|Superiority or Other|||||||0.231||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.|
1712986|NCT00797966|3152257|Superiority or Other|||||||0.9574||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 13 values presented here.|
1712987|NCT00797966|3152257|Superiority or Other|||||||0.0709||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.|
1712988|NCT00797966|3152257|Superiority or Other|||||||0.6105||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.|
1712989|NCT00797966|3152257|Superiority or Other|||||||0.8719||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 12 values presented here.|
1712990|NCT00797966|3152257|Superiority or Other|||||||0.3108||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.|
1712991|NCT00797966|3152257|Superiority or Other|||||||0.6969||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.|
1712992|NCT00797966|3152257|Superiority or Other|||||||0.8524||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 11 values presented here.|
1712993|NCT00797966|3152257|Superiority or Other|||||||0.254||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.|
1714822|NCT00778258|3155387|Superiority or Other|||||||0.156||||||Correlation = -0.20|Spearman Correlation|||Month 24 Comparison|
1712994|NCT00797966|3152257|Superiority or Other|||||||0.5964||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.|
1712995|NCT00797966|3152257|Superiority or Other|||||||0.6131||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 10 values presented here.|
1712996|NCT00797966|3152257|Superiority or Other|||||||0.4012||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.|
1712997|NCT00797966|3152257|Superiority or Other|||||||0.8838||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.|
1712998|NCT00797966|3152257|Superiority or Other|||||||0.3998||||||Cochran-Mantel-Haenszel row mean scores differ test controlling for study center.|Cochran-Mantel-Haenszel|||Week 9 values presented here.|
1712999|NCT00797966|3152258|Superiority or Other||Mean Difference (Final Values)|-1.36||||0.0919|2-Sided|95.0|-2.95|0.22|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.||
1713000|NCT00797966|3152258|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.9479|2-Sided|95.0|-1.66|1.55|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.||
1713001|NCT00797966|3152258|Superiority or Other||Mean Difference (Final Values)|-0.54||||0.5953|2-Sided|95.0|-2.54|1.46|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.||
1713002|NCT00797966|3152264|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.0161|2-Sided|95.0|-1.2|-0.12|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.||
1713003|NCT00797966|3152264|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.4902|2-Sided|95.0|-0.73|0.35|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.||
1713004|NCT00797966|3152264|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.4954|2-Sided|95.0|-0.86|0.42|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.||
1713005|NCT00797966|3152265|Superiority or Other||Mean Difference (Final Values)|1.54||||0.407|2-Sided|95.0|-2.1|5.17|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.||
1713006|NCT00797966|3152265|Superiority or Other||Mean Difference (Final Values)|0.61||||0.7412|2-Sided|95.0|-3.02|4.24|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.||
1713007|NCT00797966|3152265|Superiority or Other||Mean Difference (Final Values)|1.68||||0.449|2-Sided|95.0|-2.67|6.02|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.||
1713008|NCT00797966|3152266|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.0064|2-Sided|95.0|-0.6|-0.1|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.||
1713009|NCT00797966|3152266|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.4193|2-Sided|95.0|-0.35|0.15|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo.||
1713010|NCT00797966|3152266|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.4166|2-Sided|95.0|-0.43|0.18|||ANCOVA||Treatment difference = difference in adjusted mean change: OPC-34712 - placebo||
1713011|NCT00797966|3152267|Superiority or Other||Mean Difference (Final Values)|-2.14||||0.0303|2-Sided|95.0|-4.08|-0.21|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg’s procedure for handling the two primary efficacy comparisons.|
1713012|NCT00797966|3152267|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.7037|2-Sided|95.0|-2.3|1.55|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg’s procedure for handling the two primary efficacy comparisons.|
1713013|NCT00797966|3152267|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.6551|2-Sided|95.0|-2.87|1.81|||ANCOVA|||The planned sample size of 120 participants per arm will yield 80% power to detect the treatment effects at a 2-tailed significance level of 0.025. The 0.025 significance level corresponds to the second level of Hochberg’s procedure for handling the two primary efficacy comparisons.|
1713014|NCT00797797|3152277|Superiority or Other||Least Square Mean Difference|-14.35|||||2-Sided|95.0|-18.99|-9.71||||||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.|
1713015|NCT00797797|3152278|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||The responder rates between 'No Treatment Added' and 'Milnacipran Added' groups were compared using a logistic regression model.|
1713016|NCT00797732|3152280|Superiority|||||||0.17|||||||Wilcoxon (Mann-Whitney)||||
1713017|NCT00797277|3152306|Non-Inferiority or Equivalence|There was no previous study comparing these 2 treatments. We hypothesized that the mean difference between the 2 treatments would be small.|Mean Difference (Final Values)|1.0|||<|0.05|||||||t-test, 2 sided|||we hypothesized that there would be no statistical significant difference between the 2 groups in the primary outcome.|
1713018|NCT00797225|3152326|Superiority||LS Mean Difference|-0.47|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.66|-0.28|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713019|NCT00797225|3152326|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.1|<|0.0222|2-Sided|95.0|-0.42|-0.03|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713313|NCT00796614|3152493|Superiority or Other|||||||1|||||||Fisher Exact|||Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.|
1713020|NCT00797225|3152326|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.1|<|0.1319|2-Sided|95.0|-0.34|0.04|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713021|NCT00797225|3152326|Superiority||LS Mean Difference|-0.54|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.73|-0.35|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713022|NCT00797225|3152326|Superiority||LS Mean Difference|-0.43|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.62|-0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713023|NCT00797225|3152326|Superiority||-0.33|-0.33|Standard Error of the Mean|0.1|<|0.0007|2-Sided|95.0|-0.52|-0.14|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713024|NCT00797225|3152326|Superiority||LS Mean Difference|-0.38|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.57|-0.19|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713025|NCT00797225|3152326|Superiority||LS Mean Difference|-0.32|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.51|-0.13|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713026|NCT00797225|3152326|Superiority||LS Mean Difference|-0.32|Standard Error of the Mean|0.1|<|0.0011|2-Sided|95.0|-0.51|-0.13|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713027|NCT00797225|3152327|Superiority||LS Mean Difference|-0.79|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-1.02|-0.56|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713028|NCT00797225|3152327|Superiority||LS Mean Difference|-0.52|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.76|-0.29|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713029|NCT00797225|3152327|Superiority||LS Mean Difference|-0.41|Standard Error of the Mean|0.12|<|0.0005|2-Sided|95.0|-0.65|-0.18|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713030|NCT00797225|3152327|Superiority||LS Mean Difference|-0.82|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-1.04|-0.59|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713031|NCT00797225|3152327|Superiority||LS mean Difference|-0.64|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.87|-0.4|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713032|NCT00797225|3152327|Superiority||LS Mean Difference|-0.46|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.69|-0.23|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713033|NCT00797225|3152327|Superiority||LS Mean Difference|-0.48|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.71|-0.25|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713034|NCT00797225|3152327|Superiority||LS mean Difference|-0.5|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.73|-0.27|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713035|NCT00797225|3152327|Superiority||LS Mean Difference|-0.47|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|-0.69|-0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean dysmenorrhea scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713036|NCT00797225|3152328|Superiority||LS Mean Difference|-0.25|Standard Error of the Mean|0.08||0.0023|2-Sided|95.0|-0.41|-0.09|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713037|NCT00797225|3152328|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.08||0.6122|2-Sided|95.0|-0.2|0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713038|NCT00797225|3152328|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.08||0.5879|2-Sided|95.0|-0.21|0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713039|NCT00797225|3152328|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.08||0.0008|2-Sided|95.0|-0.44|-0.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713040|NCT00797225|3152328|Superiority||LS Mean Difference|-0.17|Standard Error of the Mean|0.08||0.0387|2-Sided|95.0|-0.33|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713041|NCT00797225|3152328|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.08||0.0556|2-Sided|95.0|-0.32|0.0|||Mixed-effects Repeated Measures Model]|||Analysis at Week 8. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713042|NCT00797225|3152328|Superiority||LS Mean Difference|-0.22|Standard Error of the Mean|0.08||0.0069|2-Sided|95.0|-0.38|-0.06|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713043|NCT00797225|3152328|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.08||0.0609|2-Sided|95.0|-0.31|0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713044|NCT00797225|3152328|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.08||0.0453|2-Sided|95.0|-0.33|0.0|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean non-menstrual pelvic pain scores was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713045|NCT00797225|3152329|Superiority||LS Mean Difference|-2.32|Standard Error of the Mean|0.48|<|0.0001|2-Sided|95.0|-3.26|-1.38|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713046|NCT00797225|3152329|Superiority||LS mean Difference|-1.38|Standard Error of the Mean|0.48|<|0.0046|2-Sided|95.0|-2.33|-0.43|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713094|NCT00796666|3152413|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|1.58|||2-Sided|95.0|-3.09|3.18|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|Baseline to Week 12|
1713047|NCT00797225|3152329|Superiority||LS Mean Difference|-0.95|Standard Error of the Mean|0.48|<|0.0509|2-Sided|95.0|-1.89|0.0|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713048|NCT00797225|3152329|Superiority||LS Mean Difference|-2.73|Standard Error of the Mean|0.48|<|0.0001|2-Sided|95.0|-3.67|-1.79|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713049|NCT00797225|3152329|Superiority||LS Mean Difference|-2.07|Standard Error of the Mean|0.48|<|0.0001|2-Sided|95.0|-3.01|-1.12|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713050|NCT00797225|3152329|Superiority||LS Mean Difference|-1.34|Standard Error of the Mean|0.48|<|0.0054|2-Sided|95.0|-2.28|-0.4|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713051|NCT00797225|3152329|Superiority||LS Mean Difference|-1.28|Standard Error of the Mean|0.47|<|0.0073|2-Sided|95.0|-2.21|-0.35|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713052|NCT00797225|3152329|Superiority||LS Mean Difference|-1.63|Standard Error of the Mean|0.47|<|0.0006|2-Sided|95.0|-2.56|-0.7|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713053|NCT00797225|3152329|Superiority||LS Mean Difference|-1.62|Standard Error of the Mean|0.48|<|0.0007|2-Sided|95.0|-2.56|-0.69|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly peak value of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713054|NCT00797225|3152330|Superiority||LS Mean Difference|-0.59|Standard Error of the Mean|0.29||0.0451|2-Sided|95.0|-1.17|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713055|NCT00797225|3152330|Superiority||LS Mean Difference|-0.25|Standard Error of the Mean|0.29||0.4022|2-Sided|95.0|-0.83|0.33|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713056|NCT00797225|3152330|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.29||0.6904|2-Sided|95.0|-0.7|0.46|||Mixed-effects Repeated Measures Model|||Analysis at Week 12. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713057|NCT00797225|3152330|Superiority||LS Mean Difference|-0.63|Standard Error of the Mean|0.28||0.028|2-Sided|95.0|-1.19|-0.07|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713058|NCT00797225|3152330|Superiority||LS Mean Difference|-0.65|Standard Error of the Mean|0.28||0.0239|2-Sided|95.0|-1.21|-0.09|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713059|NCT00797225|3152330|Superiority||LS Mean Difference|-0.33|Standard Error of the Mean|0.29||0.2563|2-Sided|95.0|-0.89|0.24|||Mixed-effects Repeated Measures Model|||Analysis at Week 8. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1714823|NCT00778258|3155387|Superiority or Other|||||||0.002||||||Correlation = -0.34|Spearman Correlation|||Month 12 Comparison|
1713060|NCT00797225|3152330|Superiority||LS Mean Difference|-0.59|Standard Error of the Mean|0.24||0.0159|2-Sided|95.0|-1.08|-0.11|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713061|NCT00797225|3152330|Superiority||LS Mean Difference|-0.65|Standard Error of the Mean|0.24||0.008|2-Sided|95.0|-1.13|-0.17|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713062|NCT00797225|3152330|Superiority||LS Mean Difference|-0.49|Standard Error of the Mean|0.25||0.0464|2-Sided|95.0|-0.98|-0.01|||Mixed-effects Repeated Measures Model|||Analysis at Week 4. The change from baseline in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed using a mixed-effects repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for participant, the baseline-by-time interaction and the baseline value as a covariate.|
1713063|NCT00797108|3152343|Superiority or Other||Clinical Cure Difference|25.0|||||2-Sided|80.0|-13.1|57.9||||||Two-sided 80% CI for the difference in the clinical cure response rates between treatement group and the comparator was formed using the exact methods.|
1713064|NCT00797108|3152343|Superiority or Other||Clinical Cure Difference|27.5|||||2-Sided|80.0|-4.0|55.3||||||Two-sided 80% confidence interval (CI) for the difference in the clinical cure response rates between treatement group and the comparator was formed using the exact methods.|
1713065|NCT00796991|3152364|Superiority or Other|||||||0.22||||||P-values were not corrected for multiple testing. F Statistic = 1.41|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.|
1713066|NCT00796991|3152364|Superiority or Other|||||||0.85||||||P-values were not corrected for multiple testing. F Statistic =0.39|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.|
1713067|NCT00796991|3152364|Superiority or Other|||||||0.37||||||P-values were not corrected for multiple testing. F Statistic =1.08|conditional F-test|5 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in the given pair of treatment groups.|
1713068|NCT00796991|3152364|Superiority or Other|||||||0.5||||||P-values were not corrected for multiple testing. F Statistic =0.94|Omnibus conditional F-test|10 Degrees Freedom (DF) in numerator and 335 DF in denominator.||null hypothesis that the pattern of mean ALC values over time is the same in all treatment groups. Test of overall time-by-treatment interaction used an omnibus conditional F-test.|
1713069|NCT00796991|3152364|Superiority or Other|||||||0.027||||||p-value was not corrected for multiple testing. F-statistic = 1.86.|conditional F test|15 degrees freedom (DF) in numerator and 335 DF in denominator.||null hypothesis of no mean ALC changes over time in any treatment group. Conditional F-tests were used to test for mean ALC changes over time in each treatment arm and the difference between treatment arms in the pattern of change in ALC over time.|
1713070|NCT00796991|3152370|Superiority or Other||Adjusted geometric mean ratio|0.982|||||2-Sided|90.0|0.7981|1.208||||||Estimated effect of dacarbazine on ipilimumab AUC: linear model was applied to ipilimumab log(AUC(0-21d)) data from Week 7 (Day 43) PK measurements in second and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination relative to ipilimumab alone.|
1713071|NCT00796991|3152370|Superiority or Other||Adjusted geometric mean ratio|0.934|||||2-Sided|90.0|0.768|1.136||||||Estimated effect of paclitaxel/carboplatin on ipilimumab AUC: linear model was applied to ipilimumab log(AUC(0-21d)) data from Week 7 (Day 43) PK measurements in first and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the 3 drug combination relative to ipilimumab alone.|
1713072|NCT00796991|3152370|Superiority or Other||Adjusted geometric mean ratio|0.97|||||2-Sided|90.0|0.891|1.056||||||Estimated effect of ipilimumab on AUC(INF) for AIC. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).|
1713073|NCT00796991|3152370|Superiority or Other||Adjusted geometric mean ratio|0.912|||||2-Sided|90.0|0.757|1.099||||||Estimated effect of ipilimumab on dacarbazine AUC(INF). Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).|
1713074|NCT00796991|3152370|Superiority or Other||Geometric mean ratio|1.068|||||2-Sided|90.0|0.954|1.196||||||Estimated effect of ipilimumab on paclitaxel AUC(INF). Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the paclitaxel/carboplatin/ipilimumab combination (Day 43) relative to paclitaxel/carboplatin alone (Day 1).|
1713075|NCT00796991|3152374|Superiority or Other||Adjusted geometric mean ratio|0.982|||||2-Sided|90.0|0.798|1.208||||||Estimated effect of dacarbazine on ipilimumab Cmax: linear model was applied to ipilimumab log(Cmax) data from Week 7 (Day 43) PK measurements in second and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination relative to ipilimumab alone.|
1714824|NCT00778258|3155387|Superiority or Other|||||||0.033||||||Correlation = -0.18|Spearman Correlation|||Baseline Comparison|
1713076|NCT00796991|3152374|Superiority or Other||Adjusted geometric mean ratio|0.934||||||90.0|0.768|1.136||||||Estimated effect of paclitaxel/carboplatin on ipilimumab Cmax: linear model was applied to ipilimumab log(Cmax)) data from Week 7 (Day 43) PK measurements in first and third arms with treatment arm as a fixed effect. Point estimates and 90% CIs for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the 3 drug combination relative to ipilimumab alone.|
1713077|NCT00796991|3152374|Superiority or Other||Adjusted geometric mean ratio|1.058|||||2-Sided|90.0|0.974|1.15||||||Estimated effect of ipilimumab on AIC Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).|
1713078|NCT00796991|3152374|Superiority or Other||Adjusted geometric mean ratio|1.027|||||2-Sided|90.0|0.848|1.243||||||Estimated effect of ipilimumab on dacarbazine Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the dacarbazine, ipilimumab combination (Day 43) relative to dacarbazine alone (Day 1).|
1713079|NCT00796991|3152374|Superiority or Other||Adjusted geometric mean ratio|0.963|||||2-Sided|90.0|0.794|1.168||||||Estimated effect of ipilimumab on paclitaxel Cmax. Point estimates and 90% confidence intervals (CIs) for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale for the paclitaxel/carboplatin/ipilimumab combination (Day 43) relative to paclitaxel/carboplatin alone (Day 1)|
1713080|NCT00796926|3152381|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1713081|NCT00796822|3152383|Superiority|There was no formal power calculation for this outcome measure as the study was powered on the primary outcome measure.|Median Difference (Net)|149.1|Standard Deviation|151.8||0.03|2-Sided|95.0|16.4|281.9|||t-test, 2 sided||||
1713082|NCT00796822|3152384|Superiority or Other||Mean Difference (Net)|-0.87|Standard Deviation|1.09||0.44|2-Sided|95.0|-1.53|3.28|||t-test, 2 sided|||The sample size was determined based on a two-sample, independent, two-tailed t-test with 5% type I error. Using the results from our pilot trial, we conservatively estimated a predicted absolute change in FMD of 3.5% with PTX (assuming no change with placebo) and we assumed a common standard deviation of 2.6%. A sample size of 10 per group was estimated to provide at least 80% power to detect this effect size. Allowing for a 20% dropout rate, we planned to recruit 13 subjects per group.|
1713083|NCT00796666|3152410|Superiority or Other|||||||0.0179||||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|ANCOVA|||Baseline to Week 12|
1713084|NCT00796666|3152410|Superiority or Other||Mean Difference (Final Values)|2.14|Standard Error of the Mean|0.85|||2-Sided|95.0|0.46|3.82|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|Baseline to Week 12|
1713085|NCT00796666|3152410|Superiority or Other||Mean Difference (Final Values)|-0.33|Standard Error of the Mean|0.86|||2-Sided|95.0|-2.05|1.38|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Physical Health Score as a covariate.|Baseline to Week 12|
1713086|NCT00796666|3152411|Superiority or Other|||||||0.2897||||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|ANCOVA|||Baseline to Week 12|
1713087|NCT00796666|3152411|Superiority or Other||Mean Difference (Final Values)|2.71|Standard Error of the Mean|1.18|||2-Sided|95.0|0.37|5.05|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|Baseline to Week 12|
1713088|NCT00796666|3152411|Superiority or Other||Mean Difference (Final Values)|1.18|Standard Error of the Mean|1.21|||2-Sided|95.0|-1.21|3.58|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Composite Mental Health Score as a covariate.|Baseline to Week 12|
1713089|NCT00796666|3152412|Superiority or Other|||||||0.2087||||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|ANCOVA|||Baseline to Week 12|
1713090|NCT00796666|3152412|Superiority or Other||Mean Difference (Final Values)|3.66|Standard Error of the Mean|1.43|||2-Sided|95.0|0.82|6.5|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|Baseline to Week 12|
1713091|NCT00796666|3152412|Superiority or Other||Mean Difference (Final Values)|1.44|Standard Error of the Mean|1.54|||2-Sided|95.0|-1.61|4.5|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Mental Health Score as a covariate.|Baseline to Week 12|
1713092|NCT00796666|3152413|Superiority or Other|||||||0.2161||||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|ANCOVA|||Baseline to Week 12|
1713093|NCT00796666|3152413|Superiority or Other||Mean Difference (Final Values)|2.27|Standard Error of the Mean|1.46|||2-Sided|95.0|-0.62|5.16|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitation Due to Emotional Problems Score as a covariate.|Baseline to Week 12|
1713095|NCT00796666|3152414|Superiority or Other|||||||0.1582||||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|ANCOVA|||Baseline to Week 12|
1713096|NCT00796666|3152414|Superiority or Other||Mean Difference (Final Values)|2.73|Standard Error of the Mean|1.31|||2-Sided|95.0|0.14|5.32|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|Baseline to Week 12|
1713097|NCT00796666|3152414|Superiority or Other||Mean Difference (Final Values)|0.45|Standard Error of the Mean|1.4|||2-Sided|95.0|-2.33|3.23|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Social Functioning Score as a covariate.|Baseline to Week 12|
1713098|NCT00796666|3152415|Superiority or Other|||||||0.0136||||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|ANCOVA|||Baseline to Week 12|
1713099|NCT00796666|3152415|Superiority or Other||Mean Difference (Final Values)|4.09|Standard Error of the Mean|1.19|||2-Sided|95.0|1.74|6.45|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|Baseline to Week 12|
1713100|NCT00796666|3152415|Superiority or Other||Mean Difference (Final Values)|0.44|Standard Error of the Mean|1.28|||2-Sided|95.0|-2.1|2.97|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Vitality Score as a covariate.|Baseline to Week 12|
1713101|NCT00796666|3152416|Superiority or Other|||||||0.0324||||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline General Health Score as a covariate.|ANCOVA|||Baseline to Week 12|
1713102|NCT00796666|3152416|Superiority or Other||Mean Difference (Final Values)|2.65|Standard Error of the Mean|1.09|||2-Sided|95.0|0.48|4.82|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline General Health Score as a covariate.|Baseline to Week 12|
1713103|NCT00796666|3152416|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|1.17|||2-Sided|95.0|-2.57|2.06|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FCvas fixed effects and baseline General Health Score as a covariate.|Baseline to Week 12|
1713104|NCT00796666|3152417|Superiority or Other|||||||0.0624||||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|ANCOVA|||Baseline to Week 12|
1713105|NCT00796666|3152417|Superiority or Other||Mean Difference (Final Values)|2.24|Standard Error of the Mean|1.34|||2-Sided|95.0|-0.41|4.9|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|Baseline to Week 12|
1713106|NCT00796666|3152417|Superiority or Other||Mean Difference (Final Values)|-0.87|Standard Error of the Mean|1.46|||2-Sided|95.0|-3.78|2.04|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Bodily Pain Score as a covariate.|Baseline to Week 12|
1713107|NCT00796666|3152418|Superiority or Other|||||||0.0244||||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|ANCOVA|||Baseline to Week 12|
1713108|NCT00796666|3152418|Superiority or Other||Mean Difference (Final Values)|1.99|Standard Error of the Mean|1.19|||2-Sided|95.0|-0.38|4.35|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|Baseline to Week 12|
1713109|NCT00796666|3152418|Superiority or Other||Mean Difference (Final Values)|-1.36|Standard Error of the Mean|1.29|||2-Sided|95.0|-3.92|1.2|||||LS mean based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Role Limitations Due to Physical Health Problems Score as a covariate.|Baseline to Week 12|
1713110|NCT00796666|3152419|Superiority or Other|||||||0.0094||||||P-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|ANCOVA|||Baseline to Week 12|
1713111|NCT00796666|3152419|Superiority or Other||Mean Difference (Final Values)|2.33|Standard Error of the Mean|1.02|||2-Sided|95.0|0.31|4.36|||||Least squared (LS) mean and p-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|Baseline to Week 12|
1713112|NCT00796666|3152419|Superiority or Other||Mean Difference (Final Values)|-0.97|Standard Error of the Mean|1.09|||2-Sided|95.0|-3.13|1.2|||||Least squared (LS) mean and p-value based on analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO FC as fixed effects and baseline Physical Functioning Score as a covariate.|Baseline to Week 12|
1713113|NCT00796666|3152420|Superiority or Other|||||||0.8223||||||Missing values at Week 12 and Week 24 were imputed with the last non-missing WHO FC based on the last observation carried forward (LOCF) method.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test used modified ridit scores and the p-value corresponding to the ANCOVA (row mean scores) statistic was reported.||Baseline to Week 12|
1713114|NCT00796666|3152421|Superiority or Other|||||||0.0049||||||P-value was based on the analysis of covariance on change from baseline with B1321003 treatment, B1321001 (NCT00795639) treatment, B1321003 Baseline WHO Functional Class (FC) as fixed effects and baseline 6 Minute Walk Distance (6MWD) as a covariate.|ANCOVA|||Baseline to Week 12|
1713115|NCT00796666|3152422|Superiority or Other||Cox Proportional Hazard|0.8616||||0.5416|2-Sided|95.0|0.602|1.233|||Log Rank||||
1713404|NCT00795600|3152758|Superiority or Other||Mean Difference (Final Values)|-2.747|Standard Error of the Mean|1.788||0.131||95.0|-6.34|0.846|||ANCOVA||||
1713116|NCT00796653|3152423|Superiority or Other||Mean Difference (Net)|0.355|Standard Error of the Mean|0.226||0.1166|2-Sided|95.0|-0.088|0.799|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455–1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Form 12mcg minus placebo|
1713117|NCT00796653|3152423|Superiority or Other||Mean Difference (Net)|0.525|Standard Error of the Mean|0.226||0.0203|2-Sided|95.0|0.082|0.967|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455–1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 10 mcg minus placebo|
1713118|NCT00796653|3152423|Superiority or Other||Mean Difference (Final Values)|0.509|Standard Error of the Mean|0.23||0.027|2-Sided|95.0|0.058|0.96|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455–1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 5mcg minus placebo|
1713119|NCT00796653|3152426|Superiority or Other||Incidence rate ratio|0.9761|Standard Error of the Mean|0.1747||0.8925||95.0|0.6869|1.387|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo||
1713120|NCT00796653|3152426|Superiority or Other||Incidence rate ratio|0.7842|Standard Error of the Mean|0.1449||0.1887||95.0|0.5456|1.1271|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo||
1713121|NCT00796653|3152426|Superiority or Other||Incidence rate ratio|0.744|Standard Error of the Mean|0.1389||0.1136||95.0|0.5158|1.0733|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo||
1713122|NCT00796653|3152427|Superiority or Other||Incidence rate ratio|1.0403|Standard Error of the Mean|0.3681||0.9112||95.0|0.5194|2.0832|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo||
1713123|NCT00796653|3152427|Superiority or Other||Incidence rate ratio|1.0078|Standard Error of the Mean|0.356||0.9824||95.0|0.5038|2.016|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo||
1713124|NCT00796653|3152427|Superiority or Other||Incidence rate ratio|0.7925|Standard Error of the Mean|0.2952||0.5326||95.0|0.3814|1.6464|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo||
1713125|NCT00796653|3152428|Superiority or Other||Incidence rate ratio|1.0631|Standard Error of the Mean|0.1748||0.7098||95.0|0.7699|1.468|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo||
1713126|NCT00796653|3152428|Superiority or Other||Incidence rate ratio|0.8631|Standard Error of the Mean|0.1451||0.3814||95.0|0.6205|1.2005|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo||
1713127|NCT00796653|3152428|Superiority or Other||Incidence rate ratio|0.785|Standard Error of the Mean|0.1342||0.1571||95.0|0.5613|1.0979|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo||
1713128|NCT00796653|3152429|Superiority or Other||Hazard Ratio (HR)|0.903|Standard Error of the Mean|0.16||0.5795||95.0|0.637|1.279|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum||
1713129|NCT00796653|3152429|Superiority or Other||Hazard Ratio (HR)|0.791|Standard Error of the Mean|0.143||0.2006||95.0|0.555|1.126|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum||
1713130|NCT00796653|3152429|Superiority or Other||Hazard Ratio (HR)|0.807|Standard Error of the Mean|0.146||0.2494||95.0|0.566|1.15|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum||
1713131|NCT00796653|3152430|Superiority or Other||Hazard Ratio (HR)|0.803|Standard Error of the Mean|0.281||0.5466||95.0|0.405|1.593|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum||
1713132|NCT00796653|3152430|Superiority or Other||Hazard Ratio (HR)|0.947|Standard Error of the Mean|0.316||0.8594||95.0|0.493|1.82|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum||
1713133|NCT00796653|3152430|Superiority or Other||Hazard Ratio (HR)|0.685|Standard Error of the Mean|0.249||0.2942||95.0|0.336|1.399|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum||
1713134|NCT00796653|3152431|Superiority or Other||Hazard Ratio (HR)|0.922|Standard Error of the Mean|0.15||0.6404||95.0|0.67|1.267|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum||
1713135|NCT00796653|3152431|Superiority or Other||Hazard Ratio (HR)|0.872|Standard Error of the Mean|0.141||0.4071||95.0|0.634|1.198|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum||
1713136|NCT00796653|3152431|Superiority or Other||Hazard Ratio (HR)|0.802|Standard Error of the Mean|0.133||0.1946||95.0|0.58|1.111|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum||
1713398|NCT00795600|3152752|Superiority or Other||Mean Difference (Final Values)|-1.585|Standard Error of the Mean|1.854||0.397||95.0|-5.31|2.141|||ANCOVA||||
1713137|NCT00796653|3152432|Superiority or Other||Mean Difference (Final Values)|0.167|Standard Error of the Mean|0.323||0.6044||95.0|-0.466|0.8|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713138|NCT00796653|3152432|Superiority or Other||Mean Difference (Final Values)|0.718|Standard Error of the Mean|0.323||0.0258||95.0|0.087|1.348|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713139|NCT00796653|3152432|Superiority or Other||Mean Difference (Final Values)|0.397|Standard Error of the Mean|0.322||0.2176||95.0|-0.234|1.027|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713140|NCT00796653|3152433|Superiority or Other||Mean Difference (Final Values)|0.114|Standard Error of the Mean|0.322||0.722||95.0|-0.516|0.745|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713141|NCT00796653|3152433|Superiority or Other||Mean Difference (Final Values)|0.481|Standard Error of the Mean|0.321||0.1341||95.0|-0.148|1.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713142|NCT00796653|3152433|Superiority or Other||Mean Difference (Final Values)|0.313|Standard Error of the Mean|0.32||0.3287||95.0|-0.315|0.941|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713143|NCT00796653|3152434|Superiority or Other||Mean Difference (Final Values)|0.309|Standard Error of the Mean|0.319||0.3335||95.0|-0.317|0.934|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713144|NCT00796653|3152434|Superiority or Other||Mean Difference (Final Values)|0.354|Standard Error of the Mean|0.318||0.2666||95.0|-0.271|0.978|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713145|NCT00796653|3152434|Superiority or Other||Mean Difference (Final Values)|0.49|Standard Error of the Mean|0.318||0.1235||95.0|-0.134|1.113|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713146|NCT00796653|3152435|Superiority or Other||Mean Difference (Final Values)|0.534|Standard Error of the Mean|0.314||0.0888||95.0|-0.081|1.15|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713147|NCT00796653|3152435|Superiority or Other||Mean Difference (Final Values)|0.492|Standard Error of the Mean|0.312||0.1142||95.0|-0.119|1.103|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713148|NCT00796653|3152435|Superiority or Other||Mean Difference (Final Values)|0.425|Standard Error of the Mean|0.311||0.1714||95.0|-0.184|1.035|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713149|NCT00796653|3152436|Superiority or Other||Mean Difference (Final Values)|0.419|Standard Error of the Mean|0.311||0.1777||95.0|-0.191|1.029|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713150|NCT00796653|3152436|Superiority or Other||Mean Difference (Final Values)|0.667|Standard Error of the Mean|0.31||0.0312||95.0|0.06|1.274|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713151|NCT00796653|3152436|Superiority or Other||Mean Difference (Final Values)|0.662|Standard Error of the Mean|0.308||0.0319||95.0|0.057|1.267|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713152|NCT00796653|3152437|Superiority or Other||Mean Difference (Final Values)|0.464|Standard Error of the Mean|0.307||0.1314||95.0|-0.139|1.066|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713153|NCT00796653|3152437|Superiority or Other||Mean Difference (Final Values)|0.706|Standard Error of the Mean|0.306||0.0211||95.0|0.106|1.307|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713154|NCT00796653|3152437|Superiority or Other||Mean Difference (Final Values)|0.437|Standard Error of the Mean|0.305||0.1524||95.0|-0.162|1.036|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713155|NCT00796653|3152438|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.1||0.7413||95.0|-0.2|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo||
1713156|NCT00796653|3152438|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.0814||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo||
1713157|NCT00796653|3152438|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.5707||95.0|-0.3|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo||
1713399|NCT00795600|3152753|Superiority or Other||Mean Difference (Final Values)|-0.278|Standard Error of the Mean|0.746||0.711||95.0|-1.778|1.221|||ANCOVA||||
1713158|NCT00796653|3152439|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.0144||95.0|-0.4|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo||
1713159|NCT00796653|3152439|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.0122||95.0|-0.4|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo||
1713160|NCT00796653|3152439|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.0555||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo||
1713161|NCT00796653|3152440|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0053||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo||
1713162|NCT00796653|3152440|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0038||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo||
1713163|NCT00796653|3152440|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.0388||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo||
1713164|NCT00796653|3152441|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0041||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo||
1713165|NCT00796653|3152441|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.0196||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo||
1713166|NCT00796653|3152441|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.0164||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo||
1713167|NCT00796653|3152442|Superiority or Other||Mean Difference (Final Values)|-0.541|Standard Error of the Mean|0.256||0.0347|2-Sided|95.0|-1.042|-0.039|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use|
1713168|NCT00796653|3152442|Superiority or Other||Mean Difference (Final Values)|-0.616|Standard Error of the Mean|0.254||0.0155|2-Sided|95.0|-1.115|-0.117|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use|
1713169|NCT00796653|3152442|Superiority or Other||Mean Difference (Final Values)|-0.424|Standard Error of the Mean|0.254||0.0959|2-Sided|95.0|-0.922|0.075|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use|
1713170|NCT00796653|3152442|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.153||0.0364|2-Sided|95.0|-0.62|-0.02|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use|
1713171|NCT00796653|3152442|Superiority or Other||Mean Difference (Final Values)|-0.365|Standard Error of the Mean|0.0163||0.0163|2-Sided|95.0|-0.662|-0.067|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use|
1713172|NCT00796653|3152442|Superiority or Other||Mean Difference (Final Values)|-0.278|Standard Error of the Mean|0.152||0.0674|2-Sided|95.0|-0.576|0.02|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use|
1713173|NCT00796653|3152442|Superiority or Other||Mean Difference (Final Values)|-0.222|Standard Error of the Mean|0.122||0.0685|2-Sided|95.0|-0.461|0.017|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use|
1713174|NCT00796653|3152442|Superiority or Other||Mean Difference (Final Values)|-0.266|Standard Error of the Mean|0.121||0.0284|2-Sided|95.0|-0.504|-0.028|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use|
1713175|NCT00796653|3152442|Superiority or Other||Mean Difference (Final Values)|-0.153|Standard Error of the Mean|0.121||0.2057|2-Sided|95.0|-0.391|-0.084|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use|
1713176|NCT00796653|3152443|Superiority or Other||Mean Difference (Final Values)|15.816|Standard Error of the Mean|4.475||0.0004|2-Sided|95.0|7.032|24.599|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use|
1713177|NCT00796653|3152443|Superiority or Other||Mean Difference (Final Values)|22.875|Standard Error of the Mean|4.444|<|0.0001|2-Sided|95.0|14.153|31.596|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use|
1713178|NCT00796653|3152443|Superiority or Other||Mean Difference (Final Values)|17.4|Standard Error of the Mean|4.463|<|0.0001|2-Sided|95.0|8.64|26.16|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use|
1713179|NCT00796653|3152443|Superiority or Other||Mean Difference (Final Values)|14.249|Standard Error of the Mean|4.454|<|0.0014|2-Sided|95.0|5.506|22.991|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use|
1713180|NCT00796653|3152443|Superiority or Other||Mean Difference (Final Values)|20.871|Standard Error of the Mean|4.44|<|0.0001|2-Sided|95.0|12.158|29.584|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use|
1713181|NCT00796653|3152443|Superiority or Other||Mean Difference (Final Values)|13.707|Standard Error of the Mean|4.435|<|0.0021|2-Sided|95.0|5.004|22.411|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use|
1714825|NCT00778258|3155388|Superiority or Other|||||||0.5|||||||Kruskal-Wallis||||
1713182|NCT00796653|3152444|Superiority or Other||Mean Difference (Final Values)|0.192|Standard Error of the Mean|0.039|<|0.0001||95.0|0.115|0.269|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713183|NCT00796653|3152444|Superiority or Other||Mean Difference (Final Values)|0.214|Standard Error of the Mean|0.039|<|0.0001||95.0|0.138|0.291|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713184|NCT00796653|3152444|Superiority or Other||Mean Difference (Final Values)|0.188|Standard Error of the Mean|0.039|<|0.0001||95.0|0.111|0.265|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713185|NCT00796653|3152445|Superiority or Other||Mean Difference (Final Values)|0.207|Standard Error of the Mean|0.039|<|0.0001||95.0|0.132|0.283|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713186|NCT00796653|3152445|Superiority or Other||Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.038|<|0.0001||95.0|0.105|0.256|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713187|NCT00796653|3152445|Superiority or Other||Mean Difference (Final Values)|0.182|Standard Error of the Mean|0.039|<|0.0001||95.0|0.106|0.258|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713188|NCT00796653|3152446|Superiority or Other||Mean Difference (Final Values)|0.265|Standard Error of the Mean|0.038|<|0.0001||95.0|0.191|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713189|NCT00796653|3152446|Superiority or Other||Mean Difference (Final Values)|0.226|Standard Error of the Mean|0.038|<|0.0001||95.0|0.151|0.3|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713190|NCT00796653|3152446|Superiority or Other||Mean Difference (Final Values)|0.215|Standard Error of the Mean|0.038|<|0.0001||95.0|0.141|0.289|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713191|NCT00796653|3152447|Superiority or Other||Mean Difference (Final Values)|0.254|Standard Error of the Mean|0.038|<|0.0001||95.0|0.18|0.328|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713192|NCT00796653|3152447|Superiority or Other||Mean Difference (Final Values)|0.221|Standard Error of the Mean|0.037|<|0.0001||95.0|0.148|0.295|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713193|NCT00796653|3152447|Superiority or Other||Mean Difference (Final Values)|0.247|Standard Error of the Mean|0.038|<|0.0001||95.0|0.174|0.321|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713194|NCT00796653|3152448|Superiority or Other||Mean Difference (Final Values)|0.248|Standard Error of the Mean|0.037|<|0.0001||95.0|0.175|0.321|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713195|NCT00796653|3152448|Superiority or Other||Mean Difference (Final Values)|0.229|Standard Error of the Mean|0.037|<|0.0001||95.0|0.156|0.302|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713196|NCT00796653|3152448|Superiority or Other||Mean Difference (Final Values)|0.233|Standard Error of the Mean|0.037|<|0.0001||95.0|0.16|0.306|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713197|NCT00796653|3152449|Superiority or Other||Mean Difference (Final Values)|0.038|Standard Error of the Mean|0.038||0.3147||95.0|-0.036|0.112|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713198|NCT00796653|3152449|Superiority or Other||Mean Difference (Final Values)|0.101|Standard Error of the Mean|0.038||0.0073||95.0|0.027|0.175|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713199|NCT00796653|3152449|Superiority or Other||Mean Difference (Final Values)|0.081|Standard Error of the Mean|0.038||0.0307||95.0|0.008|0.155|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713200|NCT00796653|3152450|Superiority or Other||Mean Difference (Final Values)|0.053|Standard Error of the Mean|0.037||0.1598||95.0|-0.021|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713201|NCT00796653|3152450|Superiority or Other||Mean Difference (Final Values)|0.121|Standard Error of the Mean|0.037||0.0013||95.0|0.047|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713202|NCT00796653|3152450|Superiority or Other||Mean Difference (Final Values)|0.087|Standard Error of the Mean|0.037||0.02||95.0|0.014|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713309|NCT00796614|3152492|Superiority or Other|||||||0.744|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713203|NCT00796653|3152451|Superiority or Other||Mean Difference (Final Values)|0.042|Standard Error of the Mean|0.037||0.2573||95.0|-0.031|0.115|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713204|NCT00796653|3152451|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.037||0.0601||95.0|-0.003|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713205|NCT00796653|3152451|Superiority or Other||Mean Difference (Final Values)|0.087|Standard Error of the Mean|0.037||0.019||95.0|0.014|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713206|NCT00796653|3152452|Superiority or Other||Mean Difference (Final Values)|0.038|Standard Error of the Mean|0.037||0.2982||95.0|-0.034|0.111|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713207|NCT00796653|3152452|Superiority or Other||Mean Difference (Final Values)|0.063|Standard Error of the Mean|0.037||0.0863||95.0|-0.009|0.135|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713208|NCT00796653|3152452|Superiority or Other||Mean Difference (Final Values)|0.066|Standard Error of the Mean|0.037||0.0718||95.0|-0.006|0.139|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713209|NCT00796653|3152453|Superiority or Other||Mean Difference (Final Values)|0.078|Standard Error of the Mean|0.037||0.0339||95.0|0.006|0.149|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713210|NCT00796653|3152453|Superiority or Other||Mean Difference (Final Values)|0.121|Standard Error of the Mean|0.036||0.0009||95.0|0.05|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713211|NCT00796653|3152453|Superiority or Other||Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.037||0.0077||95.0|0.026|0.169|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713212|NCT00796653|3152454|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.036||0.0023||95.0|0.039|0.181|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713213|NCT00796653|3152454|Superiority or Other||Mean Difference (Final Values)|0.102|Standard Error of the Mean|0.036||0.0046||95.0|0.032|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713214|NCT00796653|3152454|Superiority or Other||Mean Difference (Final Values)|0.103|Standard Error of the Mean|0.036||0.0045||95.0|0.032|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713215|NCT00796653|3152455|Superiority or Other||Mean Difference (Final Values)|0.099|Standard Error of the Mean|0.036||0.0056||95.0|0.029|0.169|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713216|NCT00796653|3152455|Superiority or Other||Mean Difference (Final Values)|0.115|Standard Error of the Mean|0.036||0.0012||95.0|0.045|0.185|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713217|NCT00796653|3152455|Superiority or Other||Mean Difference (Final Values)|0.127|Standard Error of the Mean|0.036||0.0004||95.0|0.057|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713218|NCT00796653|3152456|Superiority or Other||Mean Difference (Final Values)|0.082|Standard Error of the Mean|0.035||0.0212||95.0|0.012|0.151|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713219|NCT00796653|3152456|Superiority or Other||Mean Difference (Final Values)|0.143|Standard Error of the Mean|0.035|<|0.0001||95.0|0.073|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713220|NCT00796653|3152456|Superiority or Other||Mean Difference (Final Values)|0.088|Standard Error of the Mean|0.035|<|0.0133||95.0|0.018|0.157|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713221|NCT00796653|3152457|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.037|<|0.0001||95.0|0.148|0.292|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713222|NCT00796653|3152457|Superiority or Other||Mean Difference (Final Values)|0.237|Standard Error of the Mean|0.037|<|0.0001||95.0|0.166|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713223|NCT00796653|3152457|Superiority or Other||Mean Difference (Final Values)|0.218|Standard Error of the Mean|0.037|<|0.0001||95.0|0.146|0.29|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713400|NCT00795600|3152754|Superiority or Other||Mean Difference (Final Values)|0.116|Standard Error of the Mean|1.909||0.952||95.0|-3.721|3.953|||ANCOVA||||
1713224|NCT00796653|3152458|Superiority or Other||Mean Difference (Final Values)|0.241|Standard Error of the Mean|0.036|<|0.0001||95.0|0.17|0.312|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713225|NCT00796653|3152458|Superiority or Other||Mean Difference (Final Values)|0.213|Standard Error of the Mean|0.036|<|0.0001||95.0|0.142|0.283|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713226|NCT00796653|3152458|Superiority or Other||Mean Difference (Final Values)|0.199|Standard Error of the Mean|0.036|<|0.0001||95.0|0.128|0.27|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713227|NCT00796653|3152459|Superiority or Other||Mean Difference (Final Values)|0.275|Standard Error of the Mean|0.036|<|0.0001||95.0|0.205|0.345|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713228|NCT00796653|3152459|Superiority or Other||Mean Difference (Final Values)|0.247|Standard Error of the Mean|0.035|<|0.0001||95.0|0.177|0.317|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713229|NCT00796653|3152459|Superiority or Other||Mean Difference (Final Values)|0.229|Standard Error of the Mean|0.036|<|0.0001||95.0|0.159|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713230|NCT00796653|3152460|Superiority or Other||Mean Difference (Final Values)|0.281|Standard Error of the Mean|0.035|<|0.0001||95.0|0.212|0.35|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713231|NCT00796653|3152460|Superiority or Other||Mean Difference (Final Values)|0.249|Standard Error of the Mean|0.035|<|0.0001||95.0|0.18|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713232|NCT00796653|3152460|Superiority or Other||Mean Difference (Final Values)|0.251|Standard Error of the Mean|0.035|<|0.0001||95.0|0.182|0.32|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713233|NCT00796653|3152461|Superiority or Other||Mean Difference (Final Values)|0.266|Standard Error of the Mean|0.035|<|0.0001||95.0|0.198|0.334|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713234|NCT00796653|3152461|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.035|<|0.0001||95.0|0.182|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713235|NCT00796653|3152461|Superiority or Other||Mean Difference (Final Values)|0.231|Standard Error of the Mean|0.035|<|0.0001||95.0|0.162|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713236|NCT00796653|3152462|Superiority or Other||Mean Difference (Final Values)|0.118|Standard Error of the Mean|0.02|<|0.0001||95.0|0.078|0.158|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713237|NCT00796653|3152462|Superiority or Other||Mean Difference (Final Values)|0.126|Standard Error of the Mean|0.02|<|0.0001||95.0|0.086|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713238|NCT00796653|3152462|Superiority or Other||Mean Difference (Final Values)|0.112|Standard Error of the Mean|0.02|<|0.0001||95.0|0.071|0.152|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713239|NCT00796653|3152463|Superiority or Other||Mean Difference (Final Values)|0.143|Standard Error of the Mean|0.02|<|0.0001||95.0|0.104|0.183|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713240|NCT00796653|3152463|Superiority or Other||Mean Difference (Final Values)|0.151|Standard Error of the Mean|0.02|<|0.0001||95.0|0.112|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713241|NCT00796653|3152463|Superiority or Other||Mean Difference (Final Values)|0.123|Standard Error of the Mean|0.02|<|0.0001||95.0|0.084|0.163|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713242|NCT00796653|3152464|Superiority or Other||Mean Difference (Final Values)|0.164|Standard Error of the Mean|0.02|<|0.0001||95.0|0.125|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713243|NCT00796653|3152464|Superiority or Other||Mean Difference (Final Values)|0.168|Standard Error of the Mean|0.02|<|0.0001||95.0|0.129|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713244|NCT00796653|3152464|Superiority or Other||Mean Difference (Final Values)|0.141|Standard Error of the Mean|0.02|<|0.0001||95.0|0.103|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713310|NCT00796614|3152492|Superiority or Other|||||||0.1373|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713245|NCT00796653|3152465|Superiority or Other||Mean Difference (Final Values)|0.176|Standard Error of the Mean|0.02|<|0.0001||95.0|0.137|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713246|NCT00796653|3152465|Superiority or Other||Mean Difference (Final Values)|0.181|Standard Error of the Mean|0.02|<|0.0001||95.0|0.143|0.22|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713247|NCT00796653|3152465|Superiority or Other||Mean Difference (Final Values)|0.168|Standard Error of the Mean|0.02|<|0.0001||95.0|0.13|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713248|NCT00796653|3152466|Superiority or Other||Mean Difference (Final Values)|0.153|Standard Error of the Mean|0.019|<|0.0001||95.0|0.115|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713249|NCT00796653|3152466|Superiority or Other||Mean Difference (Final Values)|0.178|Standard Error of the Mean|0.019|<|0.0001||95.0|0.14|0.216|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713250|NCT00796653|3152466|Superiority or Other||Mean Difference (Final Values)|0.161|Standard Error of the Mean|0.019|<|0.0001||95.0|0.122|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713251|NCT00796653|3152467|Superiority or Other||Mean Difference (Final Values)|0.036|Standard Error of the Mean|0.019||0.0664||95.0|-0.002|0.074|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713252|NCT00796653|3152467|Superiority or Other||Mean Difference (Final Values)|0.059|Standard Error of the Mean|0.019||0.0024||95.0|0.021|0.097|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713253|NCT00796653|3152467|Superiority or Other||Mean Difference (Final Values)|0.044|Standard Error of the Mean|0.019||0.0228||95.0|0.006|0.082|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713254|NCT00796653|3152468|Superiority or Other||Mean Difference (Final Values)|0.056|Standard Error of the Mean|0.019||0.0035||95.0|0.019|0.094|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713255|NCT00796653|3152468|Superiority or Other||Mean Difference (Final Values)|0.084|Standard Error of the Mean|0.019|<|0.0001||95.0|0.047|0.122|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713256|NCT00796653|3152468|Superiority or Other||Mean Difference (Final Values)|0.062|Standard Error of the Mean|0.019|<|0.0014||95.0|0.024|0.099|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713257|NCT00796653|3152469|Superiority or Other||Mean Difference (Final Values)|0.048|Standard Error of the Mean|0.019||0.0117||95.0|0.011|0.086|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713258|NCT00796653|3152469|Superiority or Other||Mean Difference (Final Values)|0.073|Standard Error of the Mean|0.019||0.0002||95.0|0.035|0.11|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713259|NCT00796653|3152469|Superiority or Other||Mean Difference (Final Values)|0.062|Standard Error of the Mean|0.019||0.0012||95.0|0.025|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713260|NCT00796653|3152470|Superiority or Other||Mean Difference (Final Values)|0.051|Standard Error of the Mean|0.019||0.0067||95.0|0.014|0.088|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713261|NCT00796653|3152470|Superiority or Other||Mean Difference (Final Values)|0.086|Standard Error of the Mean|0.019|<|0.0001||95.0|0.049|0.122|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713262|NCT00796653|3152470|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.019|<|0.0085||95.0|0.013|0.087|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713263|NCT00796653|3152471|Superiority or Other||Mean Difference (Final Values)|0.065|Standard Error of the Mean|0.019||0.0005||95.0|0.028|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713264|NCT00796653|3152471|Superiority or Other||Mean Difference (Final Values)|0.093|Standard Error of the Mean|0.019|<|0.0001||95.0|0.057|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713265|NCT00796653|3152471|Superiority or Other||Mean Difference (Final Values)|0.059|Standard Error of the Mean|0.019|<|0.0017||95.0|0.022|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713311|NCT00796614|3152493|Superiority or Other|||||||0.4977|||||||Fisher Exact|||Patient responded to tamsulosin-high dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.|
1713266|NCT00796653|3152472|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.018||0.0001||95.0|0.034|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713267|NCT00796653|3152472|Superiority or Other||Mean Difference (Final Values)|0.104|Standard Error of the Mean|0.018|<|0.0001||95.0|0.068|0.141|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713268|NCT00796653|3152472|Superiority or Other||Mean Difference (Final Values)|0.084|Standard Error of the Mean|0.018|<|0.0001||95.0|0.048|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713269|NCT00796653|3152473|Superiority or Other||Mean Difference (Final Values)|0.049|Standard Error of the Mean|0.018||0.0071||95.0|0.013|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713270|NCT00796653|3152473|Superiority or Other||Mean Difference (Final Values)|0.119|Standard Error of the Mean|0.018|<|0.0001||95.0|0.083|0.155|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713271|NCT00796653|3152473|Superiority or Other||Mean Difference (Final Values)|0.069|Standard Error of the Mean|0.018|<|0.0002||95.0|0.033|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713272|NCT00796653|3152474|Superiority or Other||Mean Difference (Final Values)|0.129|Standard Error of the Mean|0.02|<|0.0001||95.0|0.091|0.168|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713273|NCT00796653|3152474|Superiority or Other||Mean Difference (Final Values)|0.141|Standard Error of the Mean|0.02|<|0.0001||95.0|0.103|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713274|NCT00796653|3152474|Superiority or Other||Mean Difference (Final Values)|0.118|Standard Error of the Mean|0.02|<|0.0001||95.0|0.08|0.156|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713275|NCT00796653|3152475|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.019|<|0.0001||95.0|0.133|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713276|NCT00796653|3152475|Superiority or Other||Mean Difference (Final Values)|0.175|Standard Error of the Mean|0.019|<|0.0001||95.0|0.138|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713277|NCT00796653|3152475|Superiority or Other||Mean Difference (Final Values)|0.145|Standard Error of the Mean|0.019|<|0.0001||95.0|0.108|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713278|NCT00796653|3152476|Superiority or Other||Mean Difference (Final Values)|0.184|Standard Error of the Mean|0.019|<|0.0001||95.0|0.148|0.221|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713279|NCT00796653|3152476|Superiority or Other||Mean Difference (Final Values)|0.192|Standard Error of the Mean|0.019|<|0.0001||95.0|0.155|0.228|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713280|NCT00796653|3152476|Superiority or Other||Mean Difference (Final Values)|0.172|Standard Error of the Mean|0.019|<|0.0001||95.0|0.136|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713281|NCT00796653|3152477|Superiority or Other||Mean Difference (Final Values)|0.162|Standard Error of the Mean|0.019|<|0.0001||95.0|0.126|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713282|NCT00796653|3152477|Superiority or Other||Mean Difference (Final Values)|0.193|Standard Error of the Mean|0.019|<|0.0001||95.0|0.157|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713283|NCT00796653|3152477|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.019|<|0.0001||95.0|0.123|0.196|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713284|NCT00796653|3152478|Superiority or Other||Mean Difference (Final Values)|-1.248|Standard Error of the Mean|0.976||0.2009|2-Sided|95.0|-3.161|0.665|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Form 12 mcg minus placebo|
1713285|NCT00796653|3152478|Superiority or Other||Mean Difference (Final Values)|-3.434|Standard Error of the Mean|0.973||0.0004|2-Sided|95.0|-5.343|-1.525|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Olo 10 mcg minus placebo|
1713286|NCT00796653|3152478|Superiority or Other||Mean Difference (Final Values)|-2.846|Standard Error of the Mean|0.972||0.0034|2-Sided|95.0|-4.751|-0.94|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect||Olo 5 mcg minus placebo|
1713312|NCT00796614|3152493|Superiority or Other|||||||0.4925|||||||Fisher Exact|||Patient responded to tamsulosin-medium dose (Right Kidney) was compared to placebo. Fisher's exact test was used for this analysis.|
1713287|NCT00796653|3152479|Superiority or Other||Mean Difference (Final Values)|-3.158|Standard Error of the Mean|1.35||0.0194||95.0|-5.806|-0.511|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713288|NCT00796653|3152479|Superiority or Other||Mean Difference (Final Values)|-2.489|Standard Error of the Mean|1.341||0.0636||95.0|-5.119|0.141|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713289|NCT00796653|3152479|Superiority or Other||Mean Difference (Final Values)|-2.625|Standard Error of the Mean|1.333||0.0491||95.0|-5.241|-0.01|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713290|NCT00796653|3152480|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|1.395||0.9365||95.0|-2.625|2.848|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713291|NCT00796653|3152480|Superiority or Other||Mean Difference (Final Values)|-1.09|Standard Error of the Mean|1.391||0.4336||95.0|-3.818|1.639|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713292|NCT00796653|3152480|Superiority or Other||Mean Difference (Final Values)|-0.352|Standard Error of the Mean|1.385||0.7995||95.0|-3.068|2.365|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713293|NCT00796653|3152481|Superiority or Other||Mean Difference (Final Values)|-1.416|Standard Error of the Mean|1.365||0.2995||95.0|-4.093|1.261|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713294|NCT00796653|3152481|Superiority or Other||Mean Difference (Final Values)|-3.524|Standard Error of the Mean|1.354||0.0094||95.0|-6.18|-0.867|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713295|NCT00796653|3152481|Superiority or Other||Mean Difference (Final Values)|-3.15|Standard Error of the Mean|1.349||0.0197||95.0|-5.796|-0.503|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713296|NCT00796653|3152482|Superiority or Other||Mean Difference (Final Values)|0.602|Standard Error of the Mean|0.316||0.0572||95.0|-0.019|1.222|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713297|NCT00796653|3152482|Superiority or Other||Mean Difference (Final Values)|0.419|Standard Error of the Mean|0.314||0.1818||95.0|-0.196|1.035|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713298|NCT00796653|3152482|Superiority or Other||Mean Difference (Final Values)|0.402|Standard Error of the Mean|0.314||0.1999||95.0|-0.213|1.018|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713299|NCT00796653|3152483|Superiority or Other||Mean Difference (Final Values)|0.042|Standard Error of the Mean|0.019||0.027||95.0|0.005|0.08|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713300|NCT00796653|3152483|Superiority or Other||Mean Difference (Final Values)|0.069|Standard Error of the Mean|0.019||0.0003||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713301|NCT00796653|3152483|Superiority or Other||Mean Difference (Final Values)|0.053|Standard Error of the Mean|0.019||0.0055||95.0|0.015|0.09|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713302|NCT00796653|3152484|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.019|<|0.0001||95.0|0.112|0.188|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713303|NCT00796653|3152484|Superiority or Other||Mean Difference (Final Values)|0.154|Standard Error of the Mean|0.019|<|0.0001||95.0|0.116|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713304|NCT00796653|3152484|Superiority or Other||Mean Difference (Final Values)|0.129|Standard Error of the Mean|0.019|<|0.0001||95.0|0.091|0.167|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713305|NCT00796614|3152491|Superiority or Other|||||||0.5045|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713306|NCT00796614|3152491|Superiority or Other|||||||0.8244|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713307|NCT00796614|3152491|Superiority or Other|||||||0.0808|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713308|NCT00796614|3152492|Superiority or Other|||||||0.7703|||||||ANCOVA|||ANCOVA model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1714979|NCT00774397|3155855|Superiority or Other||||||<|0.0213||||||P-value based on Fisher’s exact test (2-sided)|Fisher Exact||||
1713314|NCT00796614|3152493|Superiority or Other|||||||0.636|||||||Regression, Logistic|||Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713315|NCT00796614|3152493|Superiority or Other|||||||0.9231|||||||Regression, Logistic|||Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713316|NCT00796614|3152493|Superiority or Other|||||||0.9669|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713317|NCT00796614|3152494|Superiority or Other|||||||0.8626|||||||Regression, Logistic|||Patient responded to tamsulosin-High dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use,and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713318|NCT00796614|3152494|Superiority or Other|||||||0.4774|||||||Regression, Logistic|||Patient responded to tamsulosin-Medium dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713319|NCT00796614|3152494|Superiority or Other|||||||0.5545|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Right Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713320|NCT00796614|3152494|Superiority or Other|||||||0.7674|||||||Regression, Logistic|||Patient responded to tamsulosin-high dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713321|NCT00796614|3152494|Superiority or Other|||||||0.8724|||||||Regression, Logistic|||Patient responded to tamsulosin-medium dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713322|NCT00796614|3152494|Superiority or Other|||||||0.5672|||||||Regression, Logistic|||Patient responded to tamsulosin-low dose (Left Kidney) was compared to placebo. Logistic regression model was used with age group, anti-cholinergic use, and geographic region as covariates. On treatment (OT) analyses approach was used.|
1713323|NCT00796614|3152495|Superiority or Other|||||||0.6709|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.|
1713324|NCT00796614|3152495|Superiority or Other|||||||0.0658|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.|
1713325|NCT00796614|3152495|Superiority or Other|||||||0.4359|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.|
1713326|NCT00796614|3152496|Superiority or Other|||||||0.6265|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.|
1713327|NCT00796614|3152496|Superiority or Other|||||||0.2676|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.|
1713328|NCT00796614|3152496|Superiority or Other|||||||0.3097|||||||ANCOVA|||ANCOVA model was used with covariates of age group, anti-cholinergic use at baseline and geographic region. On treatment (OT) analyses approach was used.|
1713329|NCT00796614|3152497|Superiority or Other|||||||0.9436|||||||Cochran−Armitage trend test|||A test of trend across the four treatment groups was performed as a secondary analysis in the proportion of responders across the dose levels using Cochran−Armitage trend test.|
1713330|NCT00796614|3152497|Superiority or Other||Odds Ratio (OR)|1.41||||0.5209|2-Sided|95.0|0.5|3.97|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.|
1713331|NCT00796614|3152497|Superiority or Other||Odds Ratio (OR)|0.59||||0.343|2-Sided|95.0|0.2|1.76|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.|
1713332|NCT00796614|3152497|Superiority or Other||Odds Ratio (OR)|1.38||||0.5388|2-Sided|95.0|0.5|3.8|||Regression, Logistic|||Logistic regression model was used with treatment variable and three covariates: age group, concomitant use of anti-cholinergic medication and geographic region. The first two covariates were used in the stratification of the randomisation. On treatment (OT) analyses approach was used.|
1713333|NCT00796445|3152532|Non-Inferiority|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature.|Hazard Ratio (HR)|0.918||||0.5419|2-Sided|95.0|0.698|1.207|||Regression, Cox|||At Follow-up analysis (up to Year 5)|
1713334|NCT00796445|3152532|Non-Inferiority|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.|Hazard Ratio (HR)|1.094||||0.5385|2-Sided|95.0|0.821|1.457|||Regression, Cox|||At Follow-up analysis (up to Year 5)|
1713335|NCT00796445|3152532|Non-Inferiority|The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement|Hazard Ratio (HR)|1.023||||0.7534|2-Sided|95.0|0.89|1.175|||Regression, Cox|||At Follow-up analysis (up to Year 5)|
1713401|NCT00795600|3152755|Superiority or Other||Mean Difference (Final Values)|0.491|Standard Error of the Mean|0.695||0.483||95.0|-0.906|1.888|||ANCOVA||||
1713336|NCT00796445|3152533|Non-Inferiority|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population without the potentially favorable gene expression signature|Hazard Ratio (HR)|0.915||||0.5375|2-Sided|95.0|0.691|1.212|||Regression, Cox|||At Final analysis (Month 30)|
1713337|NCT00796445|3152533|Non-Inferiority|The aim of this analysis was to demonstrate the clinical efficacy in terms of DFS of the recMAGE-A3 + AS15 ASCI compared to placebo in the population presenting the potentially favorable gene expression signature.|Hazard Ratio (HR)|1.111||||0.4821|2-Sided|95.0|0.828|1.491|||Regression, Cox|||At Final analysis (Month 30)|
1713338|NCT00796445|3152533|Non-Inferiority|The aim of this analysis was to demonstrate the clinical efficacy in terms of disease-free survival (DFS) of recMAGE-A3 + AS15 ASCI compared to placebo in the overall study population of patients with completely resected stage III cutaneous melanoma with macroscopic lymph node involvement.|Hazard Ratio (HR)|1.013||||0.8566|2-Sided|95.0|0.879|1.169|||Regression, Cox|||At Final analysis (Month 30)|
1713339|NCT00796367|3152537|Superiority or Other||Odds Ratio (OR)|1.35|Standard Error of the Mean|0.32||0.2169|2-Sided|95.0|0.84|2.15|||Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)|
1713340|NCT00796367|3152537|Superiority or Other||Odds Ratio (OR)|6.99|Standard Error of the Mean|1.68|<|0.0001|2-Sided|95.0|4.36|11.19||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)|
1713341|NCT00796367|3152537|Superiority or Other||Odds Ratio (OR)|9.4|Standard Error of the Mean|1.97|<|0.0001|2-Sided|95.0|6.24|14.16||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)|
1713342|NCT00796367|3152538|Superiority or Other||Mean Difference (Final Values)|1.19|Standard Error of the Mean|0.76||0.1189|2-Sided|95.0|-0.31|2.68||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)|
1713343|NCT00796367|3152538|Superiority or Other||Mean Difference (Final Values)|7.52|Standard Error of the Mean|0.799|<|0.0001|2-Sided|95.0|5.95|9.09||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)|
1713344|NCT00796367|3152538|Superiority or Other||Mean Difference (Final Values)|8.71|Standard Error of the Mean|0.673|<|0.0001|2-Sided|95.0|7.39|10.03||Intersection-union method applied in a step-down testing approach|ANCOVA|||No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)|
1713345|NCT00796224|3152548|Superiority or Other||Ratio of Geometric means (percent)|183.14||||||90.0|124.61|269.14|||||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 72 hours postdose|
1713346|NCT00796224|3152548|Superiority or Other||Ratio of Geometric means (percent)|189.35||||||90.0|129.76|276.3|||||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 48 hours postdose|
1713347|NCT00796224|3152548|Superiority or Other||Ratio of Geometric means (percent)|173.01||||||90.0|111.45|268.55|||||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 24 hours postdose|
1713348|NCT00796224|3152548|Superiority or Other||Ratio of Geometric means (percent)|174.41||||||90.0|110.07|276.36|||||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 8 hours postdose|
1713349|NCT00796224|3152548|Superiority or Other||Ratio of Geometric means (percent)|164.93||||||90.0|103.78|262.12|||||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 4 hours postdose|
1713350|NCT00796224|3152548|Superiority or Other||Ratio of Geometric means (percent)|100.07||||||90.0|57.91|172.92|||||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 3 hours postdose|
1713351|NCT00796224|3152548|Superiority or Other||Ratio of Geometric means (percent)|50.57||||||90.0|25.24|101.3|||||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 2 hours postdose|
1713352|NCT00796224|3152548|Superiority or Other||Ratio of Geometric means (percent)|65.44||||||90.0|23.56|181.77|||||Ratio (percent) = Test/Reference multiplied by 100|Serum Concentration 1 hour postdose|
1713353|NCT00796224|3152550|Superiority or Other||Ratio of Geometric Means|91.63||||||90.0|56.21|149.38|||||||
1713354|NCT00796224|3152552|Superiority or Other||Ratio of Geometric Means|157.98||||||90.0|98.87|252.44||||||Test (60 mg/kg Azithromycin ER)/ Reference (30 mg/kg Azithromycin IR)|
1713355|NCT00796003|3152568|Superiority or Other||Overall Response Rate|26.5|Standard Error of the Mean|7.6|<|0.0001|2-Sided|90.0|14.6|41.6|||Binomial test|one-tailed 5% level at a significance level||Null Hypothesis: Overall Remission Rate = 5%|
1713356|NCT00795821|3152664|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|||
1713357|NCT00795821|3152666|Superiority or Other||||||<|0.001||||||P-value for change in supine diastolic blood pressure|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|||
1713358|NCT00795821|3152666|Superiority or Other||||||<|0.002||||||P-value for change in supine systolic blood pressure|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|||
1713359|NCT00795821|3152668|Superiority or Other|||||||0.737||||||P-value for suicidal ideation|Fisher Exact||||
1713360|NCT00795821|3152670|Superiority or Other|||||||0.189||||||P-value for participants reporting prescribed medication|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.|||
1713361|NCT00795821|3152670|Superiority or Other|||||||0.495||||||P-value for participants reporting other diagnostic tests|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.|||
1713362|NCT00795821|3152670|Superiority or Other|||||||0.868||||||P-value for participants reporting use of specialist|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.|||
1713363|NCT00795821|3152670|Superiority or Other|||||||0.261||||||P-value for participants reporting use of primary doctor|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test controlling for investigator.|||
1713402|NCT00795600|3152756|Superiority or Other||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|1.662||0.716||95.0|-3.949|2.729|||ANCOVA||||
1713364|NCT00795821|3152672|Superiority or Other|||||||0.024||||||P-value for Fatigue Interference with Daily Activities|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|||
1713365|NCT00795821|3152672|Superiority or Other|||||||0.008||||||P-value for Severity of Overall Fatigue|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|||
1713366|NCT00795821|3152674|Superiority or Other|||||||0.009|||||||ANCOVA|Model terms included treatment, investigator, and baseline score.|||
1713367|NCT00795821|3152676|Superiority or Other|||||||0.003|||||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|||
1713368|NCT00795821|3152678|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|||
1713369|NCT00795821|3152680|Superiority or Other|||||||0.002|||||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|||
1713370|NCT00795821|3152682|Superiority or Other|||||||0.056|||||||ANCOVA|Model terms included treatment, investigator, and baseline score.|||
1713371|NCT00795821|3152684|Superiority or Other|||||||0.007|||||||ANCOVA|Model terms included treatment, investigator, and baseline score.|||
1713372|NCT00795821|3152686|Superiority or Other|||||||0.002|||||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|||
1713373|NCT00795821|3152688|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|||
1713374|NCT00795821|3152690|Superiority or Other||||||<|0.001||||||To control for multiple comparisons, the analysis of this secondary outcome measure was pre-specified as a gated secondary objective. As the primary hypothesis was statistically significant, this hypothesis was tested at the 0.05 significance level.|Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|||
1713375|NCT00795821|3152692|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Model terms included treatment, investigator, visit, treatment-by-visit, baseline score, and baseline-by-visit.|||
1713376|NCT00795769|3152693|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided|||Twelve patients (24%) had a greater than two-point increase in MAT score for nausea from baseline by the end of their infusion. That rate compares to the FHCRC historic rate of 58% (p <0.0001). PMID: 21372706 reference for historical data at FHCRC|
1713377|NCT00795769|3152693|Superiority or Other||||||<|0.03|||||||t-test, 1 sided|||18% n=9 of the patients vomited compared to the FHCRC historic rate of 28%. p=0.03. PMID: 21372706 reference for historical data at FHCRC.|
1713378|NCT00795704|3152697|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1713379|NCT00795704|3152699|Superiority or Other|||||||0.079|||||||t-test, 2 sided||||
1713380|NCT00795639|3152706|Superiority or Other|||||||0.2908||||||Significance tests of WHO Functional Class performed using the Cochran-Mantel-Haenszel (CMH) test, stratified by Baseline 6MWD (less than 310 meters and greater than or equal to 310 meters) and PAH Etiology (Connective Tissue Disease and others).|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores, and the p-value corresponding to ANCOVA (row mean scores) statistics were used.||Week 12|
1713381|NCT00795639|3152707|Superiority or Other||Mean Difference (Final Values)|14.0||||0.0104|2-Sided|95.0|3.0|26.0||Significance test performed using non-parametric analysis of covariance controlling for Baseline 6MWD and PAH etiology and PAH not secondary to a connective tissue disease (other).|ANCOVA||Missing value at Week 12 assigned as zero if the subject had a predefined clinical worsening event, otherwise, missing value at Week 12 imputed with the last non-missing 6MWD based on LOCF.||
1713382|NCT00795600|3152710|Superiority or Other||Mean Difference (Final Values)|1.726|Standard Error of the Mean|6.173||0.781||95.0|-10.71|14.167|||ANCOVA||||
1713383|NCT00795600|3152711|Superiority or Other||Mean Difference (Final Values)|2.062|Standard Error of the Mean|2.168||0.346||95.0|-2.3|6.423|||ANCOVA||||
1713384|NCT00795600|3152712|Superiority or Other||Mean Difference (Final Values)|0.466|Standard Error of the Mean|1.386||0.738||95.0|-2.319|3.25|||ANCOVA||||
1713385|NCT00795600|3152713|Superiority or Other||Mean Difference (Final Values)|-0.546|Standard Error of the Mean|1.283||0.673||95.0|-3.123|2.032|||ANCOVA||||
1713386|NCT00795600|3152714|Superiority or Other||Mean Difference (Final Values)|-0.629|Standard Error of the Mean|0.967||0.518||95.0|-2.572|1.313|||ANCOVA||||
1713387|NCT00795600|3152741|Superiority or Other||Mean Difference (Final Values)|-1.918|Standard Error of the Mean|4.332||0.66||95.0|-10.65|6.813|||ANCOVA||||
1713388|NCT00795600|3152742|Superiority or Other||Mean Difference (Final Values)|-10.92|Standard Error of the Mean|17.46||0.535||95.0|-46.03|24.182|||ANCOVA||||
1713389|NCT00795600|3152743|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.266||0.628||95.0|-0.663|0.403|||ANCOVA||||
1713390|NCT00795600|3152744|Superiority or Other||Mean Difference (Final Values)|-1.777|Standard Error of the Mean|3.719||0.635||95.0|-9.254|5.7|||ANCOVA||||
1713391|NCT00795600|3152745|Superiority or Other||Mean Difference (Final Values)|-0.021|Standard Error of the Mean|0.041||0.607||95.0|-0.105|0.062|||ANCOVA||||
1713392|NCT00795600|3152746|Superiority or Other||Mean Difference (Final Values)|-0.789|Standard Error of the Mean|3.85||0.839||95.0|-8.525|6.947|||ANCOVA||||
1713393|NCT00795600|3152747|Superiority or Other||Mean Difference (Final Values)|0.004|Standard Error of the Mean|0.034||0.902||95.0|-0.064|0.073|||ANCOVA||||
1713394|NCT00795600|3152748|Superiority or Other||Mean Difference (Final Values)|-4.59|Standard Error of the Mean|4.776||0.341||95.0|-14.19|5.007|||ANCOVA||||
1713395|NCT00795600|3152749|Superiority or Other||Mean Difference (Final Values)|-4.961|Standard Error of the Mean|13.007||0.705||95.0|-31.1|21.178|||ANCOVA||||
1713396|NCT00795600|3152750|Superiority or Other||Mean Difference (Final Values)|-5.061|Standard Error of the Mean|6.216||0.42||95.0|-17.55|7.43|||ANCOVA||||
1713397|NCT00795600|3152751|Superiority or Other||Mean Difference (Final Values)|-8.916|Standard Error of the Mean|10.985||0.421||95.0|-30.99|13.159|||ANCOVA||||
1713406|NCT00795600|3152760|Superiority or Other||Mean Difference (Final Values)|-0.178|Standard Error of the Mean|2.732||0.948||95.0|-5.668|5.313|||ANCOVA||||
1713407|NCT00795600|3152761|Superiority or Other||Mean Difference (Final Values)|288.21|Standard Error of the Mean|766.41||0.709||95.0|-1252.0|1828.4|||ANCOVA||||
1713408|NCT00795600|3152762|Superiority or Other||Mean Difference (Final Values)|192.81|Standard Error of the Mean|515.4||0.71||95.0|-844.0|1229.7||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.|
1713409|NCT00795600|3152763|Superiority or Other||Mean Difference (Final Values)|196.36|Standard Error of the Mean|498.7||0.696||95.0|-805.8|1198.5||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.|
1713410|NCT00795600|3152764|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|3.478||0.948||95.0|-7.588|6.407||H01: Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.|
1713411|NCT00795600|3152765|Superiority or Other||Mean Difference (Final Values)|-0.645|Standard Error of the Mean|3.364||0.849||95.0|-7.404|6.114||H01 (hypothesis): Micro detemir = micro NPH against the alternative H01: Microl detemir ≠ micro NPH.|ANCOVA|||The primary objective and endpoint of the trial was to compare the change in trunk fat mass (g) between insulin detemir versus insulin NPH at baseline and at week 26. A standard deviation of 5% was chosen based on a previous trial. A difference in trunk fat mass of 5% was considered clinically relevant also according to this trial.|
1713412|NCT00795535|3152766|Superiority or Other||||||<|0.15||||||To avoid overfitting the models, only predictors with p<0.15 were included in the final models.|Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to compare continuous predictors, whereas chi-square tests were used to compare dichotomized predictors between those with and without serious injury. Test characteristics (specificity and positive/negative predictive values) of continuous predictors were reported based on threshold values chosen for a minimum of 80% of sensitivity. Multiple logistic regression models were used to examine the marginal effect of each predictor.|
1713413|NCT00795210|3152782|Superiority or Other|||||||0.42|||||||ANOVA||||
1713414|NCT00795210|3152783|Superiority or Other|||||||0.01|||||||Kruskal-Wallis|||Kruskal-Wallis Test for overall difference between groups|
1713415|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|2.68||||||90.0|-1.37|6.73||||||Inferential analysis at 24 hour post-dose|
1713416|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|0.11||||||90.0|-3.94|4.17||||||Inferential analysis at 12 hour post-dose|
1713417|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|1.1||||||90.0|-2.95|5.15||||||Inferential analysis at 8 hour post-dose|
1713418|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|-2.19||||||90.0|-6.24|1.87||||||Inferential analysis at 4 hour post-dose|
1713419|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|-14.39||||||90.0|-18.44|-10.33||||||Inferential analysis at 2 hour post-dose|
1713420|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|-12.19||||||90.0|-16.24|-8.13||||||Inferential analysis at 1 hour post-dose|
1713421|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|-3.49||||||90.0|-7.54|0.57||||||Inferential analysis at 0.5 hour post-dose|
1713422|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|-0.59||||||90.0|-4.64|3.47||||||Inferential analysis at 24 hour post-dose|
1713423|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|-2.29||||||90.0|-6.34|1.77||||||Inferential analysis at 12 hour post-dose|
1713424|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|-5.64||||||90.0|-9.69|-1.58||||||Inferential analysis at 8 hour post-dose|
1713425|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|-0.92||||||90.0|-4.97|3.13||||||Inferential analysis at 4 hour post-dose|
1713426|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|-5.75||||||90.0|-9.81|-1.7||||||Inferential analysis at 2 hour post-dose|
1713427|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|-7.45||||||90.0|-11.51|-3.4||||||Inferential analysis at 1 hour post-dose|
1713428|NCT00795145|3152791|Superiority or Other||Mean Difference (Final Values)|-1.49||||||90.0|-5.54|2.57||||||Inferential analysis at 0.5 hour post-dose|
1713429|NCT00795145|3152792|Superiority or Other||Mean Difference (Final Values)|6.52||||||90.0|4.35|8.69||||||Inferential analysis at 24 hour post-dose|
1713430|NCT00795145|3152792|Superiority or Other||Mean Difference (Final Values)|7.05||||||90.0|4.87|9.22||||||Inferential analysis at 12 hour post-dose|
1713431|NCT00795145|3152792|Superiority or Other||Mean Difference (Final Values)|9.4||||||90.0|7.23|11.58||||||Inferential analysis at 8 hour post-dose|
1713432|NCT00795145|3152792|Superiority or Other||Mean Difference (Final Values)|9.84||||||90.0|7.67|12.01||||||Inferential analysis at 4 hour post-dose|
1713433|NCT00795145|3152792|Superiority or Other||Mean Difference (Final Values)|10.27||||||90.0|8.1|12.44||||||Inferential analysis at 2 hour post-dose|
1713434|NCT00795145|3152792|Superiority or Other||Mean Difference (Final Values)|6.83||||||90.0|4.66|9.0||||||Inferential analysis at 1 hour post-dose|
1713435|NCT00795145|3152792|Superiority or Other||Mean Difference (Final Values)|3.27||||||90.0|1.1|5.44||||||Inferential analysis at 0.5 hour post-dose|
1713436|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|1.8||||||90.0|-0.37|3.97||||||Inferential analysis at 24 hour post-dose|
1715872|NCT00764478|3157483|Superiority or Other|||||||0.0809|||||||Cochran-Mantel-Haenszel|||Day 7|
1713437|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|1.47||||||90.0|-0.7|3.64||||||Inferential analysis at 12 hour post-dose|
1713438|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|1.13||||||90.0|-1.04|3.3||||||Inferential analysis at 8 hour post-dose|
1713439|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|3.47||||||90.0|1.3|5.64||||||Inferential analysis at 4 hour post-dose|
1713440|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|-7.51||||||90.0|-9.68|-5.34||||||Inferential analysis at 2 hour post-dose|
1713441|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|-1.78||||||90.0|-3.95|0.39||||||Inferential analysis at 1 hour post-dose|
1713442|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|2.49||||||90.0|0.32|4.66||||||Inferential analysis at 0.5 hour post-dose|
1713443|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|-0.64||||||90.0|-2.81|1.53||||||Inferential analysis at 24 hour post-dose|
1713444|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|1.01||||||90.0|-1.16|3.18||||||Inferential analysis at 12 hour post-dose|
1713445|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|-1.37||||||90.0|-3.54|0.8||||||Inferential analysis at 8 hour post-dose|
1713446|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|0.4||||||90.0|-1.77|2.57||||||Inferential analysis at 4 hour post-dose|
1713447|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|-5.53||||||90.0|-7.7|-3.36||||||Inferential analysis at 2 hour post-dose|
1713448|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|-2.96||||||90.0|-5.13|-0.79||||||Inferential analysis at 1 hour post-dose|
1713449|NCT00795145|3152793|Superiority or Other||Mean Difference (Final Values)|1.47||||||90.0|-0.7|3.64||||||Inferential analysis at 0.5 hour post-dose|
1713450|NCT00794677|3152816|Superiority or Other||Mean Difference (Net)|-21.353|Standard Error of the Mean|2.22|<|1e-07||95.0|||||ANOVA||Percent change was calculated relative to the value at the end of the 2-week placebo run in period, which was either 3-weeks (for measurements made at the end of the first period) or 9 week earlier (for those made at the end of the second period).||
1713451|NCT00794677|3152817|Superiority or Other||Mean Difference (Net)|5.397|Standard Error of the Mean|1.893||0.009||95.0|||||ANOVA||Percent change was calculated relative to the value at the end of the 2-week placebo run in period, which was either 3-weeks (for measurements made at the end of the first period) or 9 week earlier (for those made at the end of the second period).||
1713452|NCT00794677|3152818|Superiority or Other||Mean Difference (Net)|-21.846|Standard Error of the Mean|2.866|<|1e-07||95.0|||||ANOVA||Percent change was calculated relative to the value at the end of the 2-week placebo run in period, which was either 3-weeks (for measurements made at the end of the first period) or 9 week earlier (for those made at the end of the second period).||
1713453|NCT00794677|3152819|Superiority or Other||Mean Difference (Net)|-15.412|Standard Error of the Mean|1.569|<|0.0001||95.0|||||ANOVA||Percent change was calculated relative to the value at the end of the 2-week placebo run in period, which was either 3-weeks (for measurements made at the end of the first period) or 9 week earlier (for those made at the end of the second period).||
1713454|NCT00794677|3152820|Superiority or Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.14||0.3||95.0|||||ANOVA||||
1713455|NCT00794677|3152821|Superiority or Other||Mean Difference (Final Values)|0.209|Standard Error of the Mean|0.47||0.67||95.0|||||ANOVA||||
1713456|NCT00794677|3152822|Superiority or Other||Mean Difference (Final Values)|-0.048|Standard Error of the Mean|0.089||0.6||95.0|||||ANOVA||||
1713457|NCT00794677|3152823|Superiority or Other||Mean Difference (Final Values)|-0.273|Standard Error of the Mean|0.102||0.01||95.0|||||ANOVA||||
1713458|NCT00794677|3152824|Superiority or Other||Mean Difference (Final Values)|-0.252|Standard Error of the Mean|0.112||0.03||95.0|||||ANOVA|||Statistical significance was determined for a standard two-period crossover design using JMP software (Version 5.0, SAS Institute. Cary, NC).|
1713459|NCT00794664|3152826|Superiority or Other|||||||0.647||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided||||
1713460|NCT00794664|3152828|Superiority or Other|||||||0.278||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided||||
1713461|NCT00794664|3152830|Superiority or Other||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test||||
1713462|NCT00794664|3152832|Superiority or Other||||||<|0.032||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided||||
1713463|NCT00794664|3152834|Superiority or Other||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided||||
1713464|NCT00794664|3152836|Superiority or Other|||||||0.034||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided||||
1713465|NCT00794664|3152838|Superiority or Other||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in total cholesterol at PET).|t-test, 2 sided||||
1713466|NCT00794664|3152840|Superiority or Other||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in Apo B at PET).|t-test, 2 sided||||
1713467|NCT00794664|3152842|Superiority or Other||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided||||
1713468|NCT00794664|3152844|Superiority or Other||||||<|0.001||||||Statistical significance was concluded if p≤0.05|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C was approximately 22%. With 15 patients in the control group and 30 patients in the mipomersen-treated group, this study would have at least 80% power to detect a 20 percentage point difference between the 2 treatment groups. Enrollment was to be conducted such that at least 51 patients were randomized to allow for potential exclusions from an analysis set.|
1713469|NCT00794040|3152940|Superiority||Mean Difference (Final Values)|1.02||||0.598|2-Sided|95.0|-4.23|2.19||priori threshold p<0.05|Multilevel growth curve model||||
1713470|NCT00794040|3152941|Superiority||Mean Difference (Final Values)|0.02||||0.993|2-Sided|95.0|-4.76|4.8||priori threshold p<0.05|Multilevel growth curve model||||
1713471|NCT00794040|3152942|Superiority||Mean Difference (Final Values)|4.72||||0.124|2-Sided|95.0|-1.3|10.74||priori threshold p<0.05|Wilcoxon (Mann-Whitney)||||
1713472|NCT00794040|3152943|Superiority||Mean Difference (Final Values)|-0.62||||0.085|2-Sided|95.0|-1.32|0.09||priori threshold <0.05|Multilevel growth curve model||||
1713473|NCT00794040|3152944|Superiority||Odds Ratio (OR)|11.7||||0.006|2-Sided|95.0|2.0|68.16||priori threshold p<0.05|Multilevel growth curve model||||
1713474|NCT00793624|3153001|Superiority or Other||Mean Difference (Final Values)|0.355|Standard Error of the Mean|0.226||0.1166||95.0|-0.088|0.799|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455–1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Form 12mcg minus placebo|
1713475|NCT00793624|3153001|Superiority or Other||Mean Difference (Final Values)|0.525|Standard Error of the Mean|0.226||0.0203||95.0|0.082|0.967||See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455–1497(2004)|pattern mixture model||"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 10 mcg minus placebo|
1713476|NCT00793624|3153001|Superiority or Other||Mean Difference (Final Values)|0.509|Standard Error of the Mean|0.23||0.027||95.0|0.058|0.96|||pattern mixture model|See Hogan, et. al. Hogan JW, Roy J, Korkontzelou C Tutorial in biostatistics:handling drop-out in longitudinal studies. Stat Med 23,1455–1497(2004)|"Based on a pattern mixture model with four patterns based on time of dropout (i.e., day of last observed data)~1) day 43 or day 85, 2) day 127 or day 169, 3) day 225 or day 281, 4) day 337"|Olo 5mcg minus placebo|
1713477|NCT00793624|3153004|Superiority or Other||Incidence rate ratio|0.781|Standard Error of the Mean|0.1516||0.2033||95.0|0.5336|1.1433|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo||
1713478|NCT00793624|3153004|Superiority or Other||Incidence rate ratio|1.0733|Standard Error of the Mean|0.1957||0.6983||95.0|0.7503|1.5352|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo||
1713479|NCT00793624|3153004|Superiority or Other||Incidence rate ratio|1.1621|Standard Error of the Mean|0.2075||0.4002||95.0|0.8187|1.6497|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo||
1713480|NCT00793624|3153005|Superiority or Other||Incidence rate ratio|1.0289|Standard Error of the Mean|0.6013||0.9611||95.0|0.3268|3.2395|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo||
1713481|NCT00793624|3153005|Superiority or Other||Incidence rate ratio|2.3877|Standard Error of the Mean|1.3119||0.1135||95.0|0.8122|7.0194|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo||
1713482|NCT00793624|3153005|Superiority or Other||Incidence rate ratio|1.8821|Standard Error of the Mean|1.0358||0.2508||95.0|0.6391|5.543|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo||
1713483|NCT00793624|3153006|Superiority or Other||Incidence rate ratio|0.8968|Standard Error of the Mean|0.1575||0.5354||95.0|0.6353|1.2659|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Form 12 mcg minus Placebo||
1713484|NCT00793624|3153006|Superiority or Other||Incidence rate ratio|1.222|Standard Error of the Mean|0.2039||0.2297||95.0|0.8808|1.6954|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo||
1713485|NCT00793624|3153006|Superiority or Other||Incidence rate ratio|1.2521|Standard Error of the Mean|0.2064||0.1729||95.0|0.906|1.7304|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo||
1713486|NCT00793624|3153007|Superiority or Other||Hazard Ratio (HR)|0.735|Standard Error of the Mean|0.143||0.1097||95.0|0.502|1.076|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum||
1713487|NCT00793624|3153007|Superiority or Other||Hazard Ratio (HR)|1.017|Standard Error of the Mean|0.184||0.9423||95.0|0.714|1.448|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum||
1713488|NCT00793624|3153007|Superiority or Other||Hazard Ratio (HR)|1.101|Standard Error of the Mean|0.195||0.5577||95.0|0.778|1.557|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum||
1713489|NCT00793624|3153008|Superiority or Other||Hazard Ratio (HR)|1.346|Standard Error of the Mean|0.664||0.5538||95.0|0.512|3.538|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum||
1713490|NCT00793624|3153008|Superiority or Other||Hazard Ratio (HR)|1.743|Standard Error of the Mean|0.817||0.2274||95.0|0.695|4.369|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum||
1713491|NCT00793624|3153008|Superiority or Other||Hazard Ratio (HR)|1.818|Standard Error of the Mean|0.841||0.191||95.0|0.734|4.503|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum||
1713492|NCT00793624|3153009|Superiority or Other||Hazard Ratio (HR)|0.854|Standard Error of the Mean|0.15||0.3589||95.0|0.605|1.205|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Form 12 mcg to placebo across stratum||
1715873|NCT00764478|3157483|Superiority or Other|||||||0.0128|||||||Cochran-Mantel-Haenszel|||Day 4|
1713493|NCT00793624|3153009|Superiority or Other||Hazard Ratio (HR)|1.186|Standard Error of the Mean|0.195||0.3023||95.0|0.859|1.636|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum||
1713494|NCT00793624|3153009|Superiority or Other||Hazard Ratio (HR)|1.162|Standard Error of the Mean|0.19||0.3424||95.0|0.843|1.603|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum||
1713495|NCT00793624|3153010|Superiority or Other||Mean Difference (Final Values)|0.107|Standard Error of the Mean|0.353||0.7618||95.0|-0.584|0.798|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713496|NCT00793624|3153010|Superiority or Other||Mean Difference (Final Values)|0.383|Standard Error of the Mean|0.352||0.2755||95.0|-0.306|1.073|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713497|NCT00793624|3153010|Superiority or Other||Mean Difference (Final Values)|0.095|Standard Error of the Mean|0.348||0.785||95.0|-0.587|0.777|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713498|NCT00793624|3153011|Superiority or Other||Mean Difference (Final Values)|-0.377|Standard Error of the Mean|0.352||0.5099||95.0|-1.068|0.314|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713499|NCT00793624|3153011|Superiority or Other||Mean Difference (Final Values)|-0.065|Standard Error of the Mean|0.351||0.8534||95.0|-0.753|0.623|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713500|NCT00793624|3153011|Superiority or Other||Mean Difference (Final Values)|-0.112|Standard Error of the Mean|0.347||0.7459||95.0|-0.793|0.568|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713501|NCT00793624|3153012|Superiority or Other||Mean Difference (Final Values)|0.234|Standard Error of the Mean|0.349||0.503||95.0|-0.451|0.919|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713502|NCT00793624|3153012|Superiority or Other||Mean Difference (Final Values)|-0.034|Standard Error of the Mean|0.348||0.9227||95.0|-0.717|0.649|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713503|NCT00793624|3153012|Superiority or Other||Mean Difference (Final Values)|0.166|Standard Error of the Mean|0.345||0.6309||95.0|-0.511|0.842|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713504|NCT00793624|3153013|Superiority or Other||Mean Difference (Final Values)|0.023|Standard Error of the Mean|0.345||0.9462||95.0|-0.653|0.7|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713505|NCT00793624|3153013|Superiority or Other||Mean Difference (Final Values)|0.434|Standard Error of the Mean|0.344||0.2073||95.0|-0.24|1.107|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713506|NCT00793624|3153013|Superiority or Other||Mean Difference (Final Values)|0.232|Standard Error of the Mean|0.342||0.4895||95.0|-0.439|0.902|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713507|NCT00793624|3153014|Superiority or Other||Mean Difference (Final Values)|0.394|Standard Error of the Mean|0.343||0.2507||95.0|-0.278|1.066|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713508|NCT00793624|3153014|Superiority or Other||Mean Difference (Final Values)|0.543|Standard Error of the Mean|0.341||0.1109||95.0|-0.125|1.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713509|NCT00793624|3153014|Superiority or Other||Mean Difference (Final Values)|0.381|Standard Error of the Mean|0.34||0.2625||95.0|-0.285|1.047|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713510|NCT00793624|3153015|Superiority or Other||Mean Difference (Final Values)|0.758|Standard Error of the Mean|0.338||0.0252||95.0|0.094|1.421|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713511|NCT00793624|3153015|Superiority or Other||Mean Difference (Final Values)|0.664|Standard Error of the Mean|0.336||0.0484||95.0|0.005|1.324|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713512|NCT00793624|3153015|Superiority or Other||Mean Difference (Final Values)|0.571|Standard Error of the Mean|0.335||0.0882||95.0|-0.085|1.227|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713513|NCT00793624|3153016|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.1006||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo||
1713854|NCT00791258|3153447|Superiority or Other||Median Difference (Net)|-14.6|||<|0.0001|2-Sided|95.0|-15.4|-13.8|||t-test, 1 sided|||4 week analysis|
1713514|NCT00793624|3153016|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.0584||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo||
1713515|NCT00793624|3153016|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.4105||95.0|-0.3|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo||
1713516|NCT00793624|3153017|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.1332||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo||
1713517|NCT00793624|3153017|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.0447||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo||
1713518|NCT00793624|3153017|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.032||95.0|-0.4|0.0|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo||
1713519|NCT00793624|3153018|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0121||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo||
1713520|NCT00793624|3153018|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.6|-0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo||
1713521|NCT00793624|3153018|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1|<|0.0021||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo||
1713522|NCT00793624|3153019|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0017||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Form 12 mcg minus Placebo||
1713523|NCT00793624|3153019|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0073||95.0|-0.5|-0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 10 mcg qd minus Placebo||
1713524|NCT00793624|3153019|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.1||0.0003||95.0|-0.6|-0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects, patient as random effect|Olo 5 mcg qd minus Placebo||
1713525|NCT00793624|3153020|Superiority or Other||Mean Difference (Final Values)|-0.473|Standard Error of the Mean|0.266||0.0758|2-Sided|95.0|-0.994|0.049|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use|
1713526|NCT00793624|3153020|Superiority or Other||Mean Difference (Final Values)|-0.902|Standard Error of the Mean|0.267||0.0008|2-Sided|95.0|-1.426|-0.378|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use|
1713527|NCT00793624|3153020|Superiority or Other||Mean Difference (Final Values)|-0.991|Standard Error of the Mean|0.269||0.0002|2-Sided|95.0|-1.518|-0.464|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daily (24h) rescue use|
1713528|NCT00793624|3153020|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.169||0.0391|2-Sided|95.0|-0.683|-0.018|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use|
1713529|NCT00793624|3153020|Superiority or Other||Mean Difference (Final Values)|-0.58|Standard Error of the Mean|0.17||0.0007|2-Sided|95.0|-0.914|-0.247|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use|
1713530|NCT00793624|3153020|Superiority or Other||Mean Difference (Final Values)|-0.602|Standard Error of the Mean|0.171||0.0005|2-Sided|95.0|-0.939|-0.266|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean nighttime rescue use|
1713531|NCT00793624|3153020|Superiority or Other||Mean Difference (Final Values)|-0.147|Standard Error of the Mean|0.132||0.2677|2-Sided|95.0|-0.406|0.113|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use|
1713532|NCT00793624|3153020|Superiority or Other||Mean Difference (Final Values)|-0.327|Standard Error of the Mean|0.133||0.0141|2-Sided|95.0|-0.587|-0.066|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use|
1713533|NCT00793624|3153020|Superiority or Other||Mean Difference (Final Values)|-0.403|Standard Error of the Mean|0.133||0.0026|2-Sided|95.0|-0.665|-0.141|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for weekly mean daytime rescue use|
1713534|NCT00793624|3153021|Superiority or Other||Mean Difference (Final Values)|17.873|Standard Error of the Mean|4.548|<|0.0001|2-Sided|95.0|8.947|26.799|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR|
1713535|NCT00793624|3153021|Superiority or Other||Mean Difference (Final Values)|18.471|Standard Error of the Mean|4.579|<|0.0001|2-Sided|95.0|9.484|27.458|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR|
1713536|NCT00793624|3153021|Superiority or Other||Mean Difference (Final Values)|17.721|Standard Error of the Mean|4.606|<|0.0001|2-Sided|95.0|8.68|26.762|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean evening PEFR|
1713537|NCT00793624|3153021|Superiority or Other||Mean Difference (Final Values)|17.642|Standard Error of the Mean|4.601|<|0.0001|2-Sided|95.0|8.61|26.673|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR|
1713855|NCT00791258|3153448|Superiority or Other||Percentage|84.8|||||2-Sided|95.0|82.4|87.0||||||20 week analysis|
1713538|NCT00793624|3153021|Superiority or Other||Mean Difference (Final Values)|14.999|Standard Error of the Mean|4.611|<|0.0012||95.0|5.949|24.049|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR|
1713539|NCT00793624|3153021|Superiority or Other||Mean Difference (Final Values)|15.067|Standard Error of the Mean|4.639|<|0.0012|2-Sided|95.0|5.962|24.173|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.||Comparison for Weekly mean morning PEFR|
1713540|NCT00793624|3153022|Superiority or Other||Mean Difference (Final Values)|0.223|Standard Error of the Mean|0.042|<|0.0001||95.0|0.141|0.304|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713541|NCT00793624|3153022|Superiority or Other||Mean Difference (Final Values)|0.178|Standard Error of the Mean|0.041|<|0.0001||95.0|0.096|0.259|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713542|NCT00793624|3153022|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.041|<|0.0003||95.0|0.07|0.231|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713543|NCT00793624|3153023|Superiority or Other||Mean Difference (Final Values)|0.217|Standard Error of the Mean|0.041|<|0.0001||95.0|0.137|0.298|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713544|NCT00793624|3153023|Superiority or Other||Mean Difference (Final Values)|0.207|Standard Error of the Mean|0.041|<|0.0001||95.0|0.127|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713545|NCT00793624|3153023|Superiority or Other||Mean Difference (Final Values)|0.173|Standard Error of the Mean|0.041|<|0.0001||95.0|0.092|0.253|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713546|NCT00793624|3153024|Superiority or Other||Mean Difference (Final Values)|0.256|Standard Error of the Mean|0.041|<|0.0001||95.0|0.177|0.336|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713547|NCT00793624|3153024|Superiority or Other||Mean Difference (Final Values)|0.238|Standard Error of the Mean|0.041|<|0.0001||95.0|0.159|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713548|NCT00793624|3153024|Superiority or Other||Mean Difference (Final Values)|0.188|Standard Error of the Mean|0.04|<|0.0001||95.0|0.108|0.267|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713549|NCT00793624|3153025|Superiority or Other||Mean Difference (Final Values)|0.265|Standard Error of the Mean|0.04|<|0.0001||95.0|0.187|0.344|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713550|NCT00793624|3153025|Superiority or Other||Mean Difference (Final Values)|0.231|Standard Error of the Mean|0.04|<|0.0001||95.0|0.153|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713551|NCT00793624|3153025|Superiority or Other||Mean Difference (Final Values)|0.209|Standard Error of the Mean|0.04|<|0.0001||95.0|0.131|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713552|NCT00793624|3153026|Superiority or Other||Mean Difference (Final Values)|0.283|Standard Error of the Mean|0.04|<|0.0001||95.0|0.205|0.361|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713553|NCT00793624|3153026|Superiority or Other||Mean Difference (Final Values)|0.206|Standard Error of the Mean|0.04|<|0.0001||95.0|0.128|0.284|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713554|NCT00793624|3153026|Superiority or Other||Mean Difference (Final Values)|0.186|Standard Error of the Mean|0.04|<|0.0001||95.0|0.108|0.264|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713555|NCT00793624|3153027|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.041||0.5511||95.0|-0.055|0.104|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713556|NCT00793624|3153027|Superiority or Other||Mean Difference (Final Values)|0.058|Standard Error of the Mean|0.04||0.1532||95.0|-0.022|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713557|NCT00793624|3153027|Superiority or Other||Mean Difference (Final Values)|0.059|Standard Error of the Mean|0.04||0.1394||95.0|-0.019|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713558|NCT00793624|3153028|Superiority or Other||Mean Difference (Final Values)|0.067|Standard Error of the Mean|0.04||0.0965||95.0|-0.012|0.147|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713559|NCT00793624|3153028|Superiority or Other||Mean Difference (Final Values)|0.059|Standard Error of the Mean|0.04||0.142||95.0|-0.02|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713560|NCT00793624|3153028|Superiority or Other||Mean Difference (Final Values)|0.083|Standard Error of the Mean|0.04||0.0385||95.0|0.004|0.162|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713561|NCT00793624|3153029|Superiority or Other||Mean Difference (Final Values)|0.058|Standard Error of the Mean|0.04||0.1492||95.0|-0.021|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713562|NCT00793624|3153029|Superiority or Other||Mean Difference (Final Values)|0.064|Standard Error of the Mean|0.04||0.1076||95.0|-0.014|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713563|NCT00793624|3153029|Superiority or Other||Mean Difference (Final Values)|0.061|Standard Error of the Mean|0.04||0.127||95.0|-0.017|0.139|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713564|NCT00793624|3153030|Superiority or Other||Mean Difference (Final Values)|0.019|Standard Error of the Mean|0.04||0.6328||95.0|-0.059|0.098|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713565|NCT00793624|3153030|Superiority or Other||Mean Difference (Final Values)|0.082|Standard Error of the Mean|0.04||0.0399||95.0|0.004|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713566|NCT00793624|3153030|Superiority or Other||Mean Difference (Final Values)|0.056|Standard Error of the Mean|0.04||0.1603||95.0|-0.022|0.134|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713567|NCT00793624|3153031|Superiority or Other||Mean Difference (Final Values)|0.004|Standard Error of the Mean|0.04||0.9267||95.0|-0.074|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713568|NCT00793624|3153031|Superiority or Other||Mean Difference (Final Values)|0.018|Standard Error of the Mean|0.04||0.6487||95.0|-0.06|0.096|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713569|NCT00793624|3153031|Superiority or Other||Mean Difference (Final Values)|0.007|Standard Error of the Mean|0.039||0.8674||95.0|-0.071|0.084|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713570|NCT00793624|3153032|Superiority or Other||Mean Difference (Final Values)|0.086|Standard Error of the Mean|0.039||0.0294||95.0|0.009|0.163|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713571|NCT00793624|3153032|Superiority or Other||Mean Difference (Final Values)|0.105|Standard Error of the Mean|0.039||0.0076||95.0|0.028|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713572|NCT00793624|3153032|Superiority or Other||Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.039||0.0136||95.0|0.02|0.173|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713573|NCT00793624|3153033|Superiority or Other||Mean Difference (Final Values)|0.136|Standard Error of the Mean|0.039||0.0005||95.0|0.06|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713574|NCT00793624|3153033|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.039||0.0007||95.0|0.055|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713575|NCT00793624|3153033|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.039||0.0043||95.0|0.035|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713576|NCT00793624|3153034|Superiority or Other||Mean Difference (Final Values)|0.085|Standard Error of the Mean|0.039||0.029||95.0|0.009|0.16|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713577|NCT00793624|3153034|Superiority or Other||Mean Difference (Final Values)|0.077|Standard Error of the Mean|0.039||0.0455||95.0|0.002|0.153|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713578|NCT00793624|3153034|Superiority or Other||Mean Difference (Final Values)|0.068|Standard Error of the Mean|0.039||0.0781||95.0|-0.008|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713579|NCT00793624|3153035|Superiority or Other||Mean Difference (Final Values)|0.243|Standard Error of the Mean|0.039|<|0.0001||95.0|0.166|0.32|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713580|NCT00793624|3153035|Superiority or Other||Mean Difference (Final Values)|0.203|Standard Error of the Mean|0.039|<|0.0001||95.0|0.126|0.28|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713856|NCT00791258|3153448|Superiority or Other||Percentage|71.3|||||2-Sided|95.0|68.3|74.1||||||12 week analysis|
1713581|NCT00793624|3153035|Superiority or Other||Mean Difference (Final Values)|0.179|Standard Error of the Mean|0.039|<|0.0001||95.0|0.103|0.256|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713582|NCT00793624|3153036|Superiority or Other||Mean Difference (Final Values)|0.242|Standard Error of the Mean|0.039|<|0.0001||95.0|0.166|0.318|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713583|NCT00793624|3153036|Superiority or Other||Mean Difference (Final Values)|0.215|Standard Error of the Mean|0.039|<|0.0001||95.0|0.139|0.291|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713584|NCT00793624|3153036|Superiority or Other||Mean Difference (Final Values)|0.182|Standard Error of the Mean|0.039|<|0.0001||95.0|0.107|0.258|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713585|NCT00793624|3153037|Superiority or Other||Mean Difference (Final Values)|0.276|Standard Error of the Mean|0.039|<|0.0001||95.0|0.201|0.352|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713586|NCT00793624|3153037|Superiority or Other||Mean Difference (Final Values)|0.254|Standard Error of the Mean|0.038|<|0.0001||95.0|0.179|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713587|NCT00793624|3153037|Superiority or Other||Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.038|<|0.0001||95.0|0.135|0.285|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713588|NCT00793624|3153038|Superiority or Other||Mean Difference (Final Values)|0.31|Standard Error of the Mean|0.038|<|0.0001||95.0|0.235|0.384|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713589|NCT00793624|3153038|Superiority or Other||Mean Difference (Final Values)|0.249|Standard Error of the Mean|0.038|<|0.0001||95.0|0.175|0.324|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713590|NCT00793624|3153038|Superiority or Other||Mean Difference (Final Values)|0.236|Standard Error of the Mean|0.038|<|0.0001||95.0|0.161|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713591|NCT00793624|3153039|Superiority or Other||Mean Difference (Final Values)|0.307|Standard Error of the Mean|0.038|<|0.0001||95.0|0.233|0.381|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713592|NCT00793624|3153039|Superiority or Other||Mean Difference (Final Values)|0.235|Standard Error of the Mean|0.038|<|0.0001||95.0|0.161|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713593|NCT00793624|3153039|Superiority or Other||Mean Difference (Final Values)|0.223|Standard Error of the Mean|0.038|<|0.0001||95.0|0.149|0.297|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713594|NCT00793624|3153040|Superiority or Other||Mean Difference (Final Values)|0.162|Standard Error of the Mean|0.023|<|0.0001||95.0|0.117|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713595|NCT00793624|3153040|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.023|<|0.0001||95.0|0.095|0.184|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713596|NCT00793624|3153040|Superiority or Other||Mean Difference (Final Values)|0.139|Standard Error of the Mean|0.023|<|0.0001||95.0|0.095|0.183|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713597|NCT00793624|3153041|Superiority or Other||Mean Difference (Final Values)|0.167|Standard Error of the Mean|0.022|<|0.0001||95.0|0.123|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713598|NCT00793624|3153041|Superiority or Other||Mean Difference (Final Values)|0.167|Standard Error of the Mean|0.022|<|0.0001||95.0|0.112|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713599|NCT00793624|3153041|Superiority or Other||Mean Difference (Final Values)|0.148|Standard Error of the Mean|0.022|<|0.0001||95.0|0.104|0.191|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713600|NCT00793624|3153042|Superiority or Other||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.022|<|0.0001||95.0|0.13|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713601|NCT00793624|3153042|Superiority or Other||Mean Difference (Final Values)|0.159|Standard Error of the Mean|0.022|<|0.0001||95.0|0.116|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713755|NCT00791921|3153260|Superiority or Other||||||<|0.05|||||||Regression, Logistic|||For ACR20 responder rate at Week 12, comparison between the CDP870 200 mg group and the placebo group was performed.|
1713602|NCT00793624|3153042|Superiority or Other||Mean Difference (Final Values)|0.165|Standard Error of the Mean|0.022|<|0.0001||95.0|0.122|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713603|NCT00793624|3153043|Superiority or Other||Mean Difference (Final Values)|0.182|Standard Error of the Mean|0.022|<|0.0001||95.0|0.139|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713604|NCT00793624|3153043|Superiority or Other||Mean Difference (Final Values)|0.152|Standard Error of the Mean|0.022|<|0.0001||95.0|0.109|0.195|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713605|NCT00793624|3153043|Superiority or Other||Mean Difference (Final Values)|0.166|Standard Error of the Mean|0.022|<|0.0001||95.0|0.124|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713606|NCT00793624|3153044|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.022|<|0.0001||95.0|0.148|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713607|NCT00793624|3153044|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.022|<|0.0001||95.0|0.108|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713608|NCT00793624|3153044|Superiority or Other||Mean Difference (Final Values)|0.177|Standard Error of the Mean|0.022|<|0.0001||95.0|0.135|0.22|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713609|NCT00793624|3153045|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.02|<|0.0001||95.0|0.04|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713610|NCT00793624|3153045|Superiority or Other||Mean Difference (Final Values)|0.059|Standard Error of the Mean|0.021|<|0.0069||95.0|0.018|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713611|NCT00793624|3153045|Superiority or Other||Mean Difference (Final Values)|0.068|Standard Error of the Mean|0.021|<|0.0011||95.0|0.027|0.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713612|NCT00793624|3153046|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.021||0.2579||95.0|-0.017|0.065|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713613|NCT00793624|3153046|Superiority or Other||Mean Difference (Final Values)|0.037|Standard Error of the Mean|0.021||0.0808||95.0|-0.004|0.078|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713614|NCT00793624|3153046|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.021||0.0537||95.0|-0.001|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713615|NCT00793624|3153047|Superiority or Other||Mean Difference (Final Values)|0.044|Standard Error of the Mean|0.021||0.0339||95.0|0.003|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713616|NCT00793624|3153047|Superiority or Other||Mean Difference (Final Values)|0.049|Standard Error of the Mean|0.021||0.0175||95.0|0.009|0.09|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713617|NCT00793624|3153047|Superiority or Other||Mean Difference (Final Values)|0.047|Standard Error of the Mean|0.021||0.0237||95.0|0.006|0.087|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713618|NCT00793624|3153048|Superiority or Other||Mean Difference (Final Values)|0.042|Standard Error of the Mean|0.021||0.0426||95.0|0.001|0.082|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713619|NCT00793624|3153048|Superiority or Other||Mean Difference (Final Values)|0.045|Standard Error of the Mean|0.02||0.0276||95.0|0.005|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713620|NCT00793624|3153048|Superiority or Other||Mean Difference (Final Values)|0.065|Standard Error of the Mean|0.02||0.0016||95.0|0.025|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713621|NCT00793624|3153049|Superiority or Other||Mean Difference (Final Values)|0.059|Standard Error of the Mean|0.02||0.0037||95.0|0.019|0.1|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713622|NCT00793624|3153049|Superiority or Other||Mean Difference (Final Values)|0.075|Standard Error of the Mean|0.02||0.0002||95.0|0.035|0.114|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713783|NCT00791518|3153337|Superiority or Other||Least squares mean difference|0.9||||||95.0|-0.2|2.1|||||Least squares mean differences are calculated as <50% group minus >=50% group and was adjusted for Investigator.||
1713623|NCT00793624|3153049|Superiority or Other||Mean Difference (Final Values)|0.083|Standard Error of the Mean|0.02|<|0.0001||95.0|0.043|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713624|NCT00793624|3153050|Superiority or Other||Mean Difference (Final Values)|0.079|Standard Error of the Mean|0.02|<|0.0001||95.0|0.039|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713625|NCT00793624|3153050|Superiority or Other||Mean Difference (Final Values)|0.078|Standard Error of the Mean|0.02|<|0.0001||95.0|0.038|0.117|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713626|NCT00793624|3153050|Superiority or Other||Mean Difference (Final Values)|0.086|Standard Error of the Mean|0.02|<|0.0001||95.0|0.047|0.125|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713627|NCT00793624|3153051|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.02|<|0.0001||95.0|0.04|0.119|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713628|NCT00793624|3153051|Superiority or Other||Mean Difference (Final Values)|0.079|Standard Error of the Mean|0.02|<|0.0001||95.0|0.04|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713629|NCT00793624|3153051|Superiority or Other||Mean Difference (Final Values)|0.087|Standard Error of the Mean|0.02|<|0.0001||95.0|0.048|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713630|NCT00793624|3153052|Superiority or Other||Mean Difference (Final Values)|0.172|Standard Error of the Mean|0.021|<|0.0001||95.0|0.13|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713631|NCT00793624|3153052|Superiority or Other||Mean Difference (Final Values)|0.146|Standard Error of the Mean|0.021|<|0.0001||95.0|0.105|0.188|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713632|NCT00793624|3153052|Superiority or Other||Mean Difference (Final Values)|0.145|Standard Error of the Mean|0.021|<|0.0001||95.0|0.103|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713633|NCT00793624|3153053|Superiority or Other||Mean Difference (Final Values)|0.185|Standard Error of the Mean|0.021|<|0.0001||95.0|0.144|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713634|NCT00793624|3153053|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.021|<|0.0001||95.0|0.129|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713635|NCT00793624|3153053|Superiority or Other||Mean Difference (Final Values)|0.178|Standard Error of the Mean|0.021|<|0.0001||95.0|0.137|0.219|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713636|NCT00793624|3153054|Superiority or Other||Mean Difference (Final Values)|0.192|Standard Error of the Mean|0.021|<|0.0001||95.0|0.152|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713637|NCT00793624|3153054|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.021|<|0.0001||95.0|0.119|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713638|NCT00793624|3153054|Superiority or Other||Mean Difference (Final Values)|0.176|Standard Error of the Mean|0.021|<|0.0001||95.0|0.136|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713639|NCT00793624|3153055|Superiority or Other||Mean Difference (Final Values)|0.206|Standard Error of the Mean|0.02|<|0.0001||95.0|0.166|0.246|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713640|NCT00793624|3153055|Superiority or Other||Mean Difference (Final Values)|0.166|Standard Error of the Mean|0.02|<|0.0001||95.0|0.126|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713641|NCT00793624|3153055|Superiority or Other||Mean Difference (Final Values)|0.186|Standard Error of the Mean|0.02|<|0.0001||95.0|0.146|0.226|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713642|NCT00793624|3153056|Superiority or Other||Mean Difference (Final Values)|-1.248|Standard Error of the Mean|0.976||0.2009||95.0|-3.161|0.665|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 10 mcg qd minus Placebo|
1713643|NCT00793624|3153056|Superiority or Other||Mean Difference (Final Values)|-3.434|Standard Error of the Mean|0.973||0.0004||95.0|-5.343|-1.525|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo|
1713756|NCT00791817|3153263|Superiority or Other||Mean Difference (Net)|1.3897|||||2-Sided|90.0|1.1998|1.6097|||||Confidence Interval is on the Ratio of Fed to Fasted|values are Geometric Means and Confidence Intervals are on the Ratio of Fed to Fasted|
1713644|NCT00793624|3153056|Superiority or Other||Mean Difference (Final Values)|-2.846|Standard Error of the Mean|0.972||0.0034||95.0|-4.751|-0.94|||Mixed Models Analysis||Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo|
1713645|NCT00793624|3153057|Superiority or Other||Mean Difference (Final Values)|0.016|Standard Error of the Mean|1.426||0.9913||95.0|-2.782|2.814|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713646|NCT00793624|3153057|Superiority or Other||Mean Difference (Final Values)|-3.565|Standard Error of the Mean|1.427||0.0126||95.0|-6.364|-0.767|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713647|NCT00793624|3153057|Superiority or Other||Mean Difference (Final Values)|-1.871|Standard Error of the Mean|1.419||0.1878||95.0|-4.655|0.914|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713648|NCT00793624|3153058|Superiority or Other||Mean Difference (Final Values)|-1.754|Standard Error of the Mean|1.386||0.2061||95.0|-4.474|0.966|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713649|NCT00793624|3153058|Superiority or Other||Mean Difference (Final Values)|-5.144|Standard Error of the Mean|1.386||0.0002||95.0|-7.864|-2.425|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713650|NCT00793624|3153058|Superiority or Other||Mean Difference (Final Values)|-2.785|Standard Error of the Mean|1.387||0.045||95.0|-5.507|-0.063|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713651|NCT00793624|3153059|Superiority or Other||Mean Difference (Final Values)|-0.952|Standard Error of the Mean|1.396||0.4954||95.0|-3.691|1.787|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713652|NCT00793624|3153059|Superiority or Other||Mean Difference (Final Values)|-3.394|Standard Error of the Mean|1.4||0.0155||95.0|-6.141|-0.648|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713653|NCT00793624|3153059|Superiority or Other||Mean Difference (Final Values)|-2.442|Standard Error of the Mean|1.401||0.0816||95.0|-5.19|0.307|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713654|NCT00793624|3153060|Superiority or Other||Mean Difference (Final Values)|-0.288|Standard Error of the Mean|0.346||0.5099||95.0|-0.908|0.451|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713655|NCT00793624|3153060|Superiority or Other||Mean Difference (Final Values)|0.022|Standard Error of the Mean|0.345||0.9494||95.0|-0.656|0.699|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713656|NCT00793624|3153060|Superiority or Other||Mean Difference (Final Values)|0.188|Standard Error of the Mean|0.343||0.5843||95.0|-0.485|0.86|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713657|NCT00793624|3153061|Superiority or Other||Mean Difference (Final Values)|0.054|Standard Error of the Mean|0.021||0.0088||95.0|0.014|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713658|NCT00793624|3153061|Superiority or Other||Mean Difference (Final Values)|0.085|Standard Error of the Mean|0.021|<|0.0001||95.0|0.044|0.125|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713659|NCT00793624|3153061|Superiority or Other||Mean Difference (Final Values)|0.078|Standard Error of the Mean|0.021|<|0.0002||95.0|0.037|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713660|NCT00793624|3153062|Superiority or Other||Mean Difference (Final Values)|0.177|Standard Error of the Mean|0.021|<|0.0001||95.0|0.136|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Form 12 mcg minus Placebo||
1713661|NCT00793624|3153062|Superiority or Other||Mean Difference (Final Values)|0.165|Standard Error of the Mean|0.021|<|0.0001||95.0|0.124|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1713662|NCT00793624|3153062|Superiority or Other||Mean Difference (Final Values)|0.151|Standard Error of the Mean|0.021|<|0.0001||95.0|0.11|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1713663|NCT00793611|3153063|Superiority or Other|||||||0.009|||||||t-test, 2 sided|||intent to treat|
1713664|NCT00793611|3153064|Superiority or Other|||||||0.17|||||||t-test, 2 sided|||intent to treat.|
1713757|NCT00791778|3153285|Superiority or Other||Hazard Ratio (HR)|1.49||||0.84|2-Sided|95.0|0.69|3.23|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization.|Sorafenib compared to Placebo||
1713784|NCT00791518|3153338|Superiority or Other||Least squares mean difference|0.7||||||95.0|-0.4|1.7|||||Least squares mean differences are calculated as <80% group minus >=80% group and was adjusted for Investigator.||
1713665|NCT00793611|3153065|Superiority or Other||Mean Difference (Net)|0.2||||0.07|||||||t-test, 2 sided|19 degrees of freedom||ITT between group differences in change scores compared for behavioral therapy and hypnotherapy groups. Power analysis: This is a pilot study underpowered find between group differences based on our power analysis(a 20% difference between groups would require 88 women, assuming 80% power and α=0.05 based on Freeman's study cited later). The purpose of this pilot study is to evaluate the feasibility of the larger study and determine the appropriate control intervention and outcomes|
1713666|NCT00793455|3153088|Superiority or Other||Rate Ratio|1.5|||<|0.05|2-Sided|95.0|1.03|2.2|||Chi-squared|||Same as primary outcome.|
1713667|NCT00793455|3153089|Superiority or Other||Rate Ratio|3.1|||<|0.05|2-Sided|95.0|1.5|6.2|||Chi-squared|||We compared the outcomes in the intervention and control groups using rate ratios and chi square test at 3 and 6 months, a 2 sided test with a p value < .05 was used to determine significance. The study was powered to detect a 10-percentage point difference in screening completion between intervention and control groups if the control rate of completion as 20% or less with 80% power.|
1713668|NCT00793325|3153134|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at three years and SGA at baseline.|
1713669|NCT00793325|3153134|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at two years and SGA at baseline.|
1713670|NCT00793325|3153134|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the height SD score for calendar age between SGA at one year and SGA at baseline.|
1713671|NCT00793325|3153135|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at three years and SGA at baseline.|
1713672|NCT00793325|3153135|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the null hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at two years and SGA at baseline.|
1713673|NCT00793325|3153135|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that there is no difference in the mean value of the change in the growth rate SD score for calendar age between SGA at one year and SGA at baseline.|
1713674|NCT00793325|3153136|Superiority or Other||||||=|0|||||||Chi-squared|||"The risk factor tested was Concomitant Drug(s). The null hypothesis is that there is no difference between With Concomitant Drug(s) and Without Concomitant Drug(s) in the frequency of treatment related adverse events."|
1713675|NCT00793325|3153137|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Renal Impairment. The null hypothesis is that there is no difference between With Renal Impairment and Without Renal Impairment in the frequency of treatment related adverse events."|
1713676|NCT00793325|3153138|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Hepatic Function Disorder. The null hypothesis is that there is no difference between with Hepatic Function Disorder and without Hepatic Function Disorder in the frequency of treatment related adverse events."|
1713677|NCT00793325|3153139|Superiority or Other||||||=|0|||||||Chi-squared|||"The risk factor tested was Complication(s). The null hypothesis is that there is no difference between With complication(s) and Without complication(s)in the frequency of treatment related adverse events."|
1713678|NCT00793325|3153140|Superiority or Other||||||=|0|||||||Chi-squared|||"The risk factor tested was Past history of any disease. The null hypothesis is that there is no difference between With past history of any disease and Without past history any disease in the frequency of treatment related adverse events."|
1713679|NCT00793325|3153141|Superiority or Other||||||=|0|||||||Cochran-Armitage Exact|||"The risk factor tested was Severity. The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of severity."|
1713680|NCT00793325|3153141|Superiority or Other||||||=|0|||||||Chi-squared|||"The risk factor tested was Severity. The null hypothesis is that there is no association between mild, moderate and severe in the frequency of treatment related adverse events."|
1713681|NCT00793325|3153142|Superiority or Other||||||=|0|||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of treatment related adverse events."|
1713682|NCT00793325|3153143|Superiority or Other||||||=|0|||||||Chi-squared|||"The risk factor tested was Age. The null hypothesis is that there is no difference between <15 years and >=15 years in the frequency of treatment related adverse events."|
1713683|NCT00792935|3153157|Superiority or Other||Proportions|-7.7||||0.361|2-Sided|95.0|-23.6|8.7|||Miettinen & Nurminen method.||The estimated value represents the difference in percentages, MK-0941 minus Glimepiride.||
1713684|NCT00792935|3153158|Superiority or Other||Mean Difference (Final Values)|0.9|Standard Error of the Mean|4.4||0.847|2-Sided|95.0|-7.9|9.6|||Constrained longitudinal analysis|||Using a standard deviation of 23.5 mg/dL, a sample size of at least 65 participants per treatment group would be required to have an 80% power to detect a true difference of 12.5 mg/dL between MK-0941 and glimepiride as measured by change from baseline in 24-hour WMG at Week 6.|
1713685|NCT00792922|3153159|Superiority||Mean Difference (Final Values)|2.4||||0.6|2-Sided|95.0|-7.7|12.5|||Regression, Linear|||"This is the statistical analysis for Niger:~We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of trachoma."|
1713686|NCT00792922|3153159|Superiority||Median Difference (Final Values)|-4.6||||0.2|2-Sided|95.0|-11.1|1.9|||Regression, Linear|||"This is the statistical analysis for Niger:~We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection."|
1713687|NCT00792922|3153159|Superiority|For each community using the baseline observed prevalence, treatment arm and parameters estimated from square root transformed model we estimated predicted prevalence.For each arm we average estimated prevalences.The difference in the adjusted mean prevalence for enhanced arm and standard arm was then calculated.In order to derive the confidence intervals for the adjusted difference, we repeated Steps 1 to 4 for 1000 bootstrap samples.The median of the adjusted mean differences were reported.|Mean Difference (Final Values)|2.6||||0.73|2-Sided|95.0|-0.3|5.3|||Ordinary least squares linear regression|||"This is the analysis done in Tanzania:~Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.~Here we are looking at the prevalence of trachoma"|
1713688|NCT00792922|3153159|Superiority|Predicted prevalence was estimated in each community using the baseline observed prevalence, treatment arm & parameters estimated from square root transformed model.For each arm estimated prevalences were averaged.Difference in adjusted mean prevalence for enhanced arm and standard arm was calculated.For confidence intervals for adjusted difference,steps 1 to 4 for 1000 bootstrap samples were repeated.Median of adjusted mean differences, corresponding 2.5 % & 97.5 % percentiles were reported.|Mean Difference (Final Values)|1.4||||0.22|2-Sided|95.0|-1.0|3.8|||Regression, Linear|||"This is analysis done in Tanzania:~Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection."|
1713689|NCT00792701|3153190|Superiority or Other (legacy)||Correlation Coefficient|0.39||||0.0003|2-Sided||||||Chi-squared|||Comparing RRM1 levels and ERCC1 levels between all patients.|
1713690|NCT00792701|3153193|Other|Correlation|Correlation Coefficient|0.39||||0.003|2-Sided||||||t-test, 2 sided||||
1713691|NCT00792688|3153198|Superiority or Other|||||||0.0331|||||||Wilcoxon (Mann-Whitney)||||
1713692|NCT00792688|3153198|Superiority or Other|||||||0.0062|||||||Wilcoxon (Mann-Whitney)||||
1713693|NCT00792636|3153200|Superiority or Other||Hazard Ratio (HR)|1.18|||||2-Sided|95.0|0.88|1.6|||||||
1713694|NCT00792636|3153200|Superiority or Other||Hazard Ratio (HR)|0.88|||||2-Sided|95.0|0.65|1.21|||||||
1713695|NCT00792636|3153201|Superiority or Other||Hazard Ratio (HR)|1.36|||||2-Sided|95.0|1.01|1.83|||||||
1713696|NCT00792636|3153201|Superiority or Other||Hazard Ratio (HR)|1.14|||||2-Sided|95.0|0.84|1.54|||||||
1713697|NCT00792636|3153202|Superiority or Other||Odds Ratio (OR)|1.6|||||2-Sided|95.0|0.6|4.2|||||||
1713698|NCT00792636|3153202|Superiority or Other||Odds Ratio (OR)|1.4|||||2-Sided|95.0|0.5|3.7|||||||
1713699|NCT00792636|3153203|Superiority or Other||Odds Ratio (OR)|2.8|||||2-Sided|95.0|0.3|25.6|||||||
1713700|NCT00792636|3153203|Superiority or Other||Odds Ratio (OR)|1.0|||||2-Sided|95.0|0.1|13.6|||||||
1713701|NCT00792636|3153204|Superiority or Other||Odds Ratio (OR)|1.3|||||2-Sided|95.0|0.7|2.2|||||||
1713702|NCT00792636|3153204|Superiority or Other||Odds Ratio (OR)|1.0|||||2-Sided|95.0|0.6|1.7|||||||
1713703|NCT00792636|3153205|Superiority or Other||Odds Ratio (OR)|1.5|||||2-Sided|95.0|0.9|2.6|||||||
1713704|NCT00792636|3153205|Superiority or Other||Odds Ratio (OR)|1.5|||||2-Sided|95.0|0.9|2.6|||||||
1713705|NCT00792636|3153210|Superiority or Other||Least-squares mean|0.8|||||2-Sided|95.0|-0.9|2.5|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure||
1713706|NCT00792636|3153210|Superiority or Other||Least-squares mean|0.3|||||2-Sided|95.0|-1.7|2.2|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure||
1713707|NCT00792636|3153211|Superiority or Other||Least-squares mean|0.5|||||2-Sided|95.0|-1.2|2.2|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure||
1713708|NCT00792636|3153211|Superiority or Other||Least-squares mean|0.4|||||2-Sided|95.0|-1.6|2.4|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure||
1713709|NCT00792636|3153212|Superiority or Other||Least-squares mean|-1.5|||||2-Sided|95.0|-2.6|-0.3|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure||
1713710|NCT00792636|3153212|Superiority or Other||Least-squares mean|-2.1|||||2-Sided|95.0|-3.4|-0.8|||||Systolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure||
1713711|NCT00792636|3153213|Superiority or Other||Least-squares mean|-0.7|||||2-Sided|95.0|-2.0|0.6|||||Diastolic blood pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure||
1713712|NCT00792636|3153213|Superiority or Other||Least-squares mean|-1.9|||||2-Sided|95.0|-3.4|-0.4|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure||
1713713|NCT00792636|3153213|Superiority or Other||Least-squares mean|-0.9|||||2-Sided|95.0|-2.2|0.3|||||Diastolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure||
1713714|NCT00792636|3153213|Superiority or Other||Least-squares mean|-1.7|||||2-Sided|95.0|-3.2|-0.3|||||Systolic Blood Pressure. The following covariates were used in this analysis: Age, Gender, Baseline migraines per month, Baseline blood pressure||
1713715|NCT00792610|3153224|Superiority or Other||Risk Difference (RD)|0.1|Standard Deviation|0.05|<|0.05||95.0|0.05|0.15|||t-test, 2 sided|||Chi-square analysis and Fischer’s exact test were used for comparing group proportions between seropositive and seronegative participants. GMT and their 95% confidence intervals were also calculated using the software developed by Kirkman, T.W. (18) An ANOVA test was performed to compare the difference of the three groups at one, six and seven months categorized by the anti-HBs titers at 7-10 days after the booster.|
1713758|NCT00791778|3153286|Superiority or Other||Hazard Ratio (HR)|1.43||||0.951|2-Sided|95.0|0.93|2.2|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization|Sorafenib compared to Placebo||
1713716|NCT00792298|3153233|Superiority or Other||LS Mean Difference: Week 4|-20.2||||0.019|2-Sided|95.0|-37.0|-3.4|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713717|NCT00792298|3153233|Superiority or Other||LS Mean Difference: Night 1|-19.1||||0.02|2-Sided|95.0|-35.1|-3.0|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713718|NCT00792298|3153233|Superiority or Other||LS Mean Difference: Week 4|-24.6||||0.003|2-Sided|95.0|-41.0|-8.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713719|NCT00792298|3153233|Superiority or Other||LS Mean Difference: Night 1|-17.4||||0.03|2-Sided|95.0|-33.1|-1.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713720|NCT00792298|3153233|Superiority or Other||LS Mean Difference: Week 4|-15.7||||0.063|2-Sided|95.0|-32.3|0.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713721|NCT00792298|3153233|Superiority or Other||LS Mean Difference: Night 1|-31.0|||<|0.001|2-Sided|95.0|-46.9|-15.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713722|NCT00792298|3153233|Superiority or Other||LS Mean Difference: Week 4|-19.6|||<|0.024|2-Sided|95.0|-36.6|-2.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713723|NCT00792298|3153233|Superiority or Other||LS Mean Difference: Night 1|-22.3|||<|0.007|2-Sided|95.0|-38.3|-6.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713724|NCT00792298|3153234|Superiority or Other||LS Mean Difference: Week 4|-2.3||||0.644|2-Sided|95.0|-12.2|7.5|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713725|NCT00792298|3153234|Superiority or Other||LS Mean Difference: Night 1|-3.4||||0.577|2-Sided|95.0|-15.6|8.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713726|NCT00792298|3153234|Superiority or Other||LS Mean Difference: Week 4|-22.3|||<|0.001|2-Sided|95.0|-32.3|-12.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713759|NCT00791778|3153287|Superiority or Other||Hazard Ratio (HR)|1.09||||0.655|2-Sided|95.0|0.72|1.63|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.10 stratified by the same factors as randomization|Sorafenib compared to Placebo|Sample size based on the primary efficacy endpoint of PFS. Clinically meaningful improvement defined as 65% increase in median PFS. With one-sided alpha of 0.10, power of 90% and a randomization ratio of 1:1 between Sorafenib and Placebo, a total of 105 PFS events were required.|
1713727|NCT00792298|3153234|Superiority or Other||LS Mean Difference: Night 1|-9.4|||<|0.13|2-Sided|95.0|-21.5|2.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713728|NCT00792298|3153234|Superiority or Other||LS Mean Difference: Week 4|-3.8|||<|0.459|2-Sided|95.0|-13.8|6.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713729|NCT00792298|3153234|Superiority or Other||LS Mean Difference: Night 1|-23.1|||<|0.001|2-Sided|95.0|-35.3|-10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713730|NCT00792298|3153234|Superiority or Other||LS Mean Difference: Week 4|-9.5|||<|0.068|2-Sided|95.0|-19.7|0.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713731|NCT00792298|3153234|Superiority or Other||LS Mean Difference: Night 1|-25.4|||<|0.001|2-Sided|95.0|-37.7|-13.1|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713732|NCT00792298|3153235|Superiority or Other||LS Mean Difference: Week 4|-21.4||||0.001|2-Sided|95.0|-34.2|-8.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713733|NCT00792298|3153235|Superiority or Other||LS Mean Difference: Night 1|-21.2|||<|0.001|2-Sided|95.0|-33.5|-8.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713734|NCT00792298|3153235|Superiority or Other||LS Mean Difference: Week 4|-28.1|||<|0.001|2-Sided|95.0|-41.0|-15.1|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713735|NCT00792298|3153235|Superiority or Other||LS Mean Difference: Night 1|-24.7|||<|0.001|2-Sided|95.0|-37.1|-12.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713736|NCT00792298|3153235|Superiority or Other||LS Mean Difference: Week 4|-33.2|||<|0.001|2-Sided|95.0|-46.3|-20.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713737|NCT00792298|3153235|Superiority or Other||LS Mean Difference: Night 1|-33.9|||<|0.001|2-Sided|95.0|-46.4|-21.5|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713760|NCT00791765|3153288|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided test with modified ridit scores stratified by baseline body mass index group|||
1713761|NCT00791765|3153289|Superiority or Other||||||<|0.0001|||||||2-sided pairwise van Elteren's test|Stratified by baseline body mass index group||Comparison of week 24 outcome to week 12 outcome (see Outcome Measure 1)|
1713762|NCT00791765|3153290|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by baseline body mass index group|||
1713738|NCT00792298|3153235|Superiority or Other||LS Mean Difference: Week 4|-28.9|||<|0.001|2-Sided|95.0|-42.1|-15.7|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713739|NCT00792298|3153235|Superiority or Other||LS Mean Difference: Night 1|-36.8|||<|0.001|2-Sided|95.0|-49.4|-24.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713740|NCT00792298|3153236|Superiority or Other||LS Mean Difference: Week 4|4.7||||0.003|2-Sided|95.0|1.6|7.8|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713741|NCT00792298|3153236|Superiority or Other||LS Mean Difference: Night 1|5.2||||0.002|2-Sided|95.0|1.9|8.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713742|NCT00792298|3153236|Superiority or Other||LS Mean Difference: Week 4|10.4|||<|0.001|2-Sided|95.0|7.2|13.6|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713743|NCT00792298|3153236|Superiority or Other||LS Mean Difference: Night 1|7.6|||<|0.001|2-Sided|95.0|4.2|11.0|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713744|NCT00792298|3153236|Superiority or Other||LS Mean Difference: Week 4|7.8|||<|0.001|2-Sided|95.0|4.6|10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713745|NCT00792298|3153236|Superiority or Other||LS Mean Difference: Night 1|10.8|||<|0.001|2-Sided|95.0|7.4|14.2|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713746|NCT00792298|3153236|Superiority or Other||LS Mean Difference: Week 4|7.6|||<|0.001|2-Sided|95.0|4.4|10.9|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713747|NCT00792298|3153236|Superiority or Other||LS Mean Difference: Night 1|12.9|||<|0.001|2-Sided|95.0|9.5|16.3|||Mixed Models Analysis|||A fixed sequential testing procedure assessed statistical significance, beginning with the highest dose. The comparison of suvorexant vs placebo had to be significant at α=0.05 at both Night 1 and Week 4 in order to assess statistical significance of the comparison of suvorexant vs placebo for the next highest dose. If a non-significant result was observed at either time point, the differences between suvorexant and placebo for SE was considered nonsignificant for this and all lower doses.|
1713748|NCT00792116|3153238|Non-Inferiority or Equivalence|||||||0.05|||||||ANCOVA|Repeated Measures|||
1713749|NCT00792116|3153239|Non-Inferiority or Equivalence|||||||0.05|||||||ANCOVA|Repeated Measures|||
1713750|NCT00791999|3153250|Superiority or Other||||||<|0.05||||||Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.|Regression, Logistic||||
1713751|NCT00791999|3153251|Superiority or Other||||||<|0.025||||||Wald p-values(vs. placebo) for the comparison of the treatment groups have been calculated using logistic regression with factors for treatment.|Regression, Logistic|||For ACR20 responder rate at Week 12, treatment comparisons versus placebo for the two CDP870 dose groups, the CDP870 200 mg group the CDP870 400 mg, were performed. The ACR20 responder rate in the CDP870 100 mg group was used for the secondary analysis.|
1713752|NCT00791973|3153252|Superiority or Other|||||||0.14|||||||Wilcoxon signed-rank test||||
1713753|NCT00791973|3153253|Superiority or Other|||||||0.33|||||||Wilcoxon signed-rank test||||
1713764|NCT00791661|3153311|Superiority or Other||Difference in least squares mean|-59.4|||<|0.001|2-Sided|90.0|-75.1|-43.7||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 170 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.|
1713765|NCT00791661|3153311|Superiority or Other||Difference in least squares mean|-43.9|||<|0.001|2-Sided|90.0|-60.8|-27.0||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 140 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.|
1713766|NCT00791661|3153311|Superiority or Other||Difference in least squares mean|-15.3|||<|0.099|2-Sided|90.0|-30.5|-0.1||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 100 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.|
1713767|NCT00791661|3153311|Superiority or Other||Difference in least squares mean|-57.6|||<|0.001|2-Sided|90.0|-73.3|-41.9||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 80 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.|
1713768|NCT00791661|3153311|Superiority or Other||Difference in least squares mean|-28.9|||<|0.026|2-Sided|90.0|-49.9|-7.9|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for placebo fed minus LS mean for placebo.||
1713769|NCT00791661|3153311|Superiority or Other||Difference in least squares mean|12.3|||<|0.114|2-Sided|90.0|-0.5|25.2|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|Difference in least squares mean (LS mean) was calculated as LS mean for MK-1006 60 mg minus LS mean for MK-1006 60 mg fed.||
1713770|NCT00791661|3153311|Superiority or Other||Difference in least squares mean|-19.7|||<|0.147|2-Sided|90.0|-42.2|2.7|||Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg fed minus LS mean for placebo fed.||
1713771|NCT00791661|3153311|Superiority or Other||Diffrence in least squares mean|-36.3|||<|0.001|2-Sided|90.0|-52.0|-20.5||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.|
1713772|NCT00791661|3153311|Superiority or Other||Difference in least squares mean|-25.7|||<|0.007|2-Sided|90.0|-40.9|-10.5||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 45 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.|
1713773|NCT00791661|3153311|Superiority or Other||Difference in least squares mean|-16.6|||<|0.079|2-Sided|90.0|-32.2|-1.1||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 30 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.|
1713774|NCT00791661|3153311|Superiority or Other||Difference in least squares mean|-8.1|||<|0.368|2-Sided|90.0|-23.0|6.8||A step down procedure starting with the highest tolerated dose was implemented.|Mixed Models Analysis|Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.|The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 15 mg minus LS mean for placebo.|At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.|
1713775|NCT00791661|3153315|Superiority or Other||Geometric mean ratio (fed/fasted)|0.81||||||95.0|||||||||
1713776|NCT00791661|3153317|Superiority or Other||Geometric mean ratio (fed/fasted)|0.92||||||95.0|||||||||
1713777|NCT00791648|3153329|Superiority or Other (legacy)|||||||0.39|||||||Wilcoxon (Mann-Whitney)||||
1713778|NCT00791648|3153330|Superiority or Other (legacy)|||||||0.06|||||||Wilcoxon (Mann-Whitney)||||
1713779|NCT00791648|3153331|Superiority or Other (legacy)|||||||0.11|||||||Wilcoxon (Mann-Whitney)||||
1713780|NCT00791648|3153332|Superiority or Other (legacy)|||||||0.71|||||||Wilcoxon (Mann-Whitney)||||
1713785|NCT00791518|3153343|Superiority or Other||Least squares mean difference|0.3||||||95.0|0.2|0.4|||||Least squares mean differences are calculated as <50% group minus >=50% group and was adjusted for Investigator.||
1713786|NCT00791518|3153344|Superiority or Other||Least squares mean difference|0.2||||||95.0|0.1|0.4|||||Least squares mean differences are calculated as <80% group minus >=80% group and are adjusted for Investigator.||
1713787|NCT00791479|3153369|Superiority or Other||Mean Difference (Final Values)|-0.11||||1||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713788|NCT00791479|3153369|Superiority or Other||Mean Difference (Final Values)|0.27||||0.975||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713789|NCT00791479|3153369|Superiority or Other||Mean Difference (Final Values)|1.04||||0.247||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713790|NCT00791479|3153369|Superiority or Other||Mean Difference (Final Values)|1.19||||0.14||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713791|NCT00791479|3153369|Superiority or Other|||||||0.009||||||A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.|
1713792|NCT00791479|3153369|Superiority or Other|||||||0.969||||||A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.|
1713793|NCT00791479|3153377|Superiority or Other|||||||0.329||||||A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.|
1713794|NCT00791479|3153377|Superiority or Other|||||||0.45||||||A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.|
1713795|NCT00791479|3153378|Superiority or Other|||||||0.036||||||A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.|
1713796|NCT00791479|3153378|Superiority or Other||||||<|0.001||||||A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.|
1713797|NCT00791479|3153379|Superiority or Other||Mean Difference (Final Values)|-38.67|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713798|NCT00791479|3153379|Superiority or Other||Mean Difference (Final Values)|-36.34|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713799|NCT00791479|3153379|Superiority or Other||Mean Difference (Final Values)|-26.09|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713800|NCT00791479|3153379|Superiority or Other||Mean Difference (Final Values)|-9.65|||<|0.378||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713801|NCT00791479|3153379|Superiority or Other||||||<|0.001||||||A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.|
1713802|NCT00791479|3153379|Superiority or Other||||||<|0.001||||||A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.|
1713803|NCT00791479|3153380|Superiority or Other||||||<|0.001||||||Treatment comparison of glycosylated hemoglobin (HbA1c) levels ≤6.5%.|Cochran-Armitage trend test|The Cochran-Armitage trend test included the placebo arm.|||
1713804|NCT00791479|3153380|Superiority or Other||||||<|0.001||||||Treatment comparison of glycosylated hemoglobin (HbA1c) levels <7.0%.|Cochran-Armitage trend test|The Cochran-Armitage trend test included the placebo arm.|||
1713805|NCT00791479|3153381|Superiority or Other||Mean Difference (Final Values)|-33.71|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713806|NCT00791479|3153381|Superiority or Other||Mean Difference (Final Values)|-29.96|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713807|NCT00791479|3153381|Superiority or Other||Mean Difference (Final Values)|-26.53|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713808|NCT00791479|3153381|Superiority or Other||Mean Difference (Final Values)|-7.81|||<|0.456||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713809|NCT00791479|3153381|Superiority or Other||||||<|0.001||||||A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.|
1713810|NCT00791479|3153381|Superiority or Other||||||<|0.001||||||A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.|
1713811|NCT00791479|3153382|Superiority or Other||||||<|0.001||||||Treatment comparison at Week 8. A priori threshold for statistical significance was P<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.|
1713812|NCT00791479|3153382|Superiority or Other||||||<|0.001||||||Treatment comparison at Week 8. A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.|
1713813|NCT00791479|3153382|Superiority or Other||||||<|0.023||||||Treatment comparison at Week 4. A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.|
1713814|NCT00791479|3153382|Superiority or Other||||||<|0.001||||||Treatment comparison at Week 4. A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.|
1713815|NCT00791479|3153383|Superiority or Other||Mean Difference (Final Values)|-1.04|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713853|NCT00791258|3153447|Superiority or Other||Mean Difference (Net)|-16.6|||<|0.0001|2-Sided|95.0|-17.7|-15.7|||t-test, 1 sided|||8 week analysis|
1713816|NCT00791479|3153383|Superiority or Other||Mean Difference (Final Values)|-1.04|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713817|NCT00791479|3153383|Superiority or Other||Mean Difference (Final Values)|-0.89|||<|0.001||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713818|NCT00791479|3153383|Superiority or Other||Mean Difference (Final Values)|-0.37|||<|0.069||||||An adjustment for multiplicity was performed when comparing the individual doses to placebo using a Dunnett's test.|Mixed Models Analysis||||
1713819|NCT00791479|3153383|Superiority or Other||||||<|0.001||||||A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response without placebo.|
1713820|NCT00791479|3153383|Superiority or Other||||||<|0.001||||||A priori threshold for statistical significance was p<0.05.|Mixed Models Analysis|||Test of log linear dose response with placebo.|
1713821|NCT00791258|3153433|Superiority or Other||Mean Difference (Net)|-11.3|||<|0.0001|2-Sided|95.0|-12.6|-10.0|||t-test, 1 sided|||Diastolic blood pressure - last 6 hours of dose|
1713822|NCT00791258|3153433|Superiority or Other||Mean Difference (Net)|-11.6|||<|0.0001|2-Sided|95.0|-12.9|-10.2|||t-test, 1 sided|||Diastolic blood pressure - last 4 hours of dose|
1713823|NCT00791258|3153433|Superiority or Other||Mean Difference (Net)|-12.3|||<|0.0001|2-Sided|95.0|-13.8|-10.8|||t-test, 1 sided|||Diastolic blood pressure - last 2 hours of dose|
1713824|NCT00791258|3153433|Superiority or Other||Mean Difference (Net)|-11.1|||<|0.0001|2-Sided|95.0|-12.4|-9.8|||t-test, 1 sided|||Mean nighttime diastolic blood pressure|
1713825|NCT00791258|3153433|Superiority or Other||Mean Difference (Net)|-15.0|||<|0.0001|2-Sided|95.0|-16.2|-13.8|||t-test, 1 sided|||Mean daytime diastolic blood pressure|
1713826|NCT00791258|3153433|Superiority or Other||Mean Difference (Net)|-13.3|||<|0.0001|2-Sided|95.0|-14.4|-12.2|||t-test, 1 sided|||24-hour mean diastolic blood pressure|
1713827|NCT00791258|3153433|Superiority or Other||Mean Difference (Net)|-17.9|||<|0.0001|2-Sided|95.0|-19.7|-16.0|||t-test, 1 sided|||Systolic blood pressure - last 6 hours of dose|
1713828|NCT00791258|3153433|Superiority or Other||Mean Difference (Net)|-18.2|||<|0.0001|2-Sided|95.0|-20.2|-16.3|||t-test, 1 sided|||Systolic blood pressure - last 4 hours of dose|
1713829|NCT00791258|3153433|Superiority or Other||Mean Difference (Net)|-19.6|||<|0.0001|2-Sided|95.0|-21.7|-17.4|||t-test, 1 sided|||Systolic blood pressure - last 2 hours of dose|
1713830|NCT00791258|3153433|Superiority or Other||Mean Difference (Net)|-17.5|||<|0.0001|2-Sided|95.0|-19.4|-15.6|||t-test, 1 sided|||Mean nighttime systolic blood pressure|
1713831|NCT00791258|3153433|Superiority or Other||Mean Difference (Net)|-23.2|||<|0.0001|2-Sided|95.0|-25.1|-21.4|||t-test, 1 sided|||Mean daytime systolic blood pressure|
1713832|NCT00791258|3153433|Superiority or Other||Mean Difference (Net)|-21.0|||<|0.0001|2-Sided|95.0|-22.6|-19.3|||t-test, 1 sided|||24-hour mean systolic blood pressure|
1713833|NCT00791258|3153434|Superiority or Other||Mean Difference (Net)|-7.7|||<|0.0001||95.0|-8.8|-6.6|||t-test, 1 sided|||diastolic blood pressure during last 6 hours of dose|
1713834|NCT00791258|3153434|Superiority or Other||Mean Difference (Net)|-8.0|||<|0.0001|2-Sided|95.0|-9.2|-6.8|||t-test, 1 sided|||diastolic blood pressure during last 4 hours of dose|
1713835|NCT00791258|3153434|Superiority or Other||Mean Difference (Net)|-8.6|||<|0.0001||95.0|-10.0|-7.2|||t-test, 1 sided|||diastolic blood pressure during last 2 hours of dose|
1713836|NCT00791258|3153434|Superiority or Other||Mean Difference (Net)|-7.6|||<|0.0001|2-Sided|95.0|-8.8|-6.4|||t-test, 1 sided|||Mean nighttime diastolic blood pressure|
1713837|NCT00791258|3153434|Superiority or Other||Mean Difference (Net)|-10.6|||<|0.0001|2-Sided|95.0|-11.7|-9.6|||t-test, 1 sided|||Mean daytime diastolic blood pressure|
1713838|NCT00791258|3153434|Superiority or Other||Mean Difference (Net)|-9.4|||<|0.0001||95.0|-10.3|-8.5|||t-test, 1 sided|||Mean 24-hour diastolic blood pressure|
1713839|NCT00791258|3153434|Superiority or Other||Mean Difference (Net)|-12.6|||<|0.0001|2-Sided|95.0|-14.3|-10.9|||t-test, 1 sided|||systolic blood pressure during last 6 hours of dose|
1713840|NCT00791258|3153434|Superiority or Other||Mean Difference (Net)|-13.0|||<|0.0001|2-Sided|95.0|-14.7|-11.2|||t-test, 1 sided|||systolic blood pressure during last 4 hours of dose|
1713841|NCT00791258|3153434|Superiority or Other||Mean Difference (Net)|-13.6|||<|0.0001|2-Sided|95.0|-15.7|-11.6|||t-test, 1 sided|||systolic blood pressure during last 2 hours of dose|
1713842|NCT00791258|3153434|Superiority or Other||Mean Difference (Net)|-12.5|||<|0.0001|2-Sided|95.0|-14.1|-10.8|||t-test, 1 sided|||Mean nighttime systolic blood pressure|
1713843|NCT00791258|3153434|Superiority or Other||Mean Difference (Net)|-16.3|||<|0.0001|2-Sided|95.0|-17.8|-14.8|||t-test, 1 sided|||Mean daytime systolic blood pressure|
1713844|NCT00791258|3153434|Superiority or Other||Mean Difference (Net)|-14.8|||<|0.0001|2-Sided|95.0|-16.2|-13.4|||t-test, 1 sided|||Mean 24-hour systolic blood pressure|
1713845|NCT00791258|3153446|Superiority or Other||Mean Difference (Net)|-14.5||||0.0001|2-Sided|95.0|-15.1|-13.8|||t-test, 1 sided|||20 week analysis|
1713846|NCT00791258|3153446|Superiority or Other||Mean Difference (Net)|-14.6|||<|0.0001|2-Sided|95.0|-15.2|-14.0|||t-test, 1 sided|||16 week analysis|
1713847|NCT00791258|3153446|Superiority or Other||Mean Difference (Net)|-11.9|||<|0.0001|2-Sided|95.0|-12.5|-11.4|||t-test, 1 sided|||12 week analysis|
1713848|NCT00791258|3153446|Superiority or Other||Mean Difference (Net)|-9.1|||<|0.0001|2-Sided|95.0|-9.7|-8.5|||t-test, 1 sided|||8 week analysis|
1713849|NCT00791258|3153446|Superiority or Other||Mean Difference (Net)|-8.1|||<|0.0001|2-Sided|95.0|-8.6|-7.6|||t-test, 1 sided|||4 week analysis|
1713850|NCT00791258|3153447|Superiority or Other||Mean Difference (Net)|-26.8|||<|0.0001|2-Sided|95.0|-27.8|-25.7|||t-test, 1 sided|||20 week analysis|
1713851|NCT00791258|3153447|Superiority or Other||Mean Difference (Net)|-26.0|||<|0.0001|2-Sided|95.0|-27.0|-25.0|||t-test, 1 sided|||16 week analysis|
1713852|NCT00791258|3153447|Superiority or Other||Mean Difference (Net)|-21.8|||<|0.0001|2-Sided|95.0|-22.7|-20.9|||t-test, 1 sided|||12 week analysis|
1713857|NCT00791258|3153449|Superiority or Other||Percentage|84.3|||||2-Sided|95.0|81.8|86.5|||||||
1713860|NCT00790842|3153548|Other|Recommended phase 2 dose for Group C|Lenalidomide dose in mg/day|25.0|||||2-Sided||||||||Because no dose limiting toxicities were observed, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance < 30 mL/min who are receiving dialysis|Recommended phase 2 dose for Group C|
1713861|NCT00790842|3153548|Other|Recommended phase 2 dose for patients in Group B|Dose in milligrams/day|25.0|||||2-Sided||||||||Because no dose limiting toxicities were noted, the recommended phase 2 dose of lenalidomide is 25 mg/day for patients with creatinine clearance < 30 mL/minute who are not on dialysis|Recommended phase 2 dose for patients in Group B|
1713862|NCT00790842|3153548|Other|Recommended Phase 2 dose for Group A|Dose in milligrams per day|25.0|||||2-Sided||||||||Because no dose limiting toxicities were noted, the recommended phase 2 dose for patients with creatinine clearance of 30 to 60 mL/min is 25 mg/day|Recommended Phase 2 dose for Group A|
1713863|NCT00790400|3153615|Superiority or Other||||||<|0.0001|||||||Clopper-Pearson||||
1713864|NCT00790335|3153616|Superiority||Mean Difference (Net)|-0.46|Standard Error of the Mean|0.23||0.05|2-Sided||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|||
1713865|NCT00790335|3153617|Superiority||Mean Difference (Net)|-0.53|Standard Error of the Mean|0.23||0.02|2-Sided||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|||
1713866|NCT00790335|3153618|Superiority||Mean Difference (Net)|-0.34|Standard Error of the Mean|0.15||0.03|2-Sided||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|||
1713867|NCT00790335|3153619|Superiority||Mean Difference (Net)|-0.33|Standard Error of the Mean|0.14||0.02|2-Sided||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|||
1713868|NCT00790335|3153620|Superiority||Mean Difference (Net)|4.2|Standard Error of the Mean|2.39||0.08|2-Sided||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No significant difference in the change from baseline to 24 months between the two treatment arms.||
1713869|NCT00790335|3153621|Superiority||Mean Difference (Net)|0.0|Standard Error of the Mean|1.16||0.99|2-Sided||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No difference was observed in the degree of change from baseline to 24 months in the two treatment groups.||
1713870|NCT00790335|3153622|Superiority||Mean Difference (Net)|1.13|Standard Error of the Mean|1.26||0.37|2-Sided||||||Regression, Linear|Adjusted by extent of thrombus and clinical center|No significant difference was seen in the degree of change from baseline to 24 months between the two treatment arms.||
1713871|NCT00790335|3153623|Superiority||Mean Difference (Net)|-0.55|Standard Error of the Mean|0.26||0.03|2-Sided||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm||
1713872|NCT00790335|3153624|Superiority||Mean Difference (Net)|-1.06|Standard Error of the Mean|0.24|<|0.001|2-Sided||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm||
1713873|NCT00790335|3153625|Superiority||Mean Difference (Net)|-0.56|Standard Error of the Mean|0.23||0.01|2-Sided||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm||
1713874|NCT00790335|3153626|Superiority||Mean Difference (Net)|-0.95|Standard Error of the Mean|0.21|<|0.001|2-Sided||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm||
1713875|NCT00790335|3153627|Superiority||Mean Difference (Net)|-1.06|Standard Error of the Mean|0.38||0.005|2-Sided||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm||
1713876|NCT00790335|3153628|Superiority||Mean Difference (Net)|-1.12|Standard Error of the Mean|0.31|<|0.001|2-Sided||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm||
1713877|NCT00790335|3153629|Superiority||Mean Difference (Net)|-1.17|Standard Error of the Mean|0.28|<|0.001|2-Sided||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm||
1713878|NCT00790335|3153630|Superiority||Mean Difference (Net)|-1.22|Standard Error of the Mean|0.31|<|0.001|2-Sided||||||Regression, Linear|Piecewise linear-regression growth-curve models with adjustment for extent of DVT, clinical center) and pre-specified baseline co-variates|Lower (better) mean scores in the PCDT Arm||
1713879|NCT00790335|3153631|Superiority||Risk Ratio (RR)|0.89||||0.83|2-Sided|95.0|0.33|2.44|||Cochran-Mantel-Haenszel||||
1713880|NCT00790335|3153633|Superiority||Risk Ratio (RR)|1.47||||0.09|2-Sided|95.0|0.94|2.29|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm||
1713881|NCT00790335|3153634|Superiority||Risk Ratio (RR)|1.53||||0.5|2-Sided|95.0|0.44|5.28|||Cochran-Mantel-Haenszel||Numerator = PCDT Arm; Denominator = Control Arm||
1713882|NCT00790335|3153635|Superiority||Risk Ratio (RR)|1.26||||0.25|2-Sided|95.0|0.85|1.89|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm||
1713883|NCT00790335|3153636|Superiority||Risk Ratio (RR)|2.64||||0.03|2-Sided|95.0|1.04|6.68|||Cochran-Mantel-Haenszel||Numerator = PCDT Arm; Denominator = Control Arm. Bleeding was more frequent in the PCDT Arm.||
1713884|NCT00790335|3153637|Superiority||Risk Ratio (RR)|1.52||||0.23|2-Sided|95.0|0.76|3.01|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm||
1713885|NCT00790335|3153638|Superiority||Risk Ratio (RR)|6.18||||0.049|2-Sided|95.0|0.78|49.2|||Cochran-Mantel-Haenszel||Numerator: PCDT Arm; Denominator: Control Arm. More major bleeding was observed in the PCDT Arm.||
1713886|NCT00790335|3153639|Superiority||Risk Ratio (RR)|0.73||||0.04|2-Sided|95.0|0.54|0.98|||Cochran-Mantel-Haenszel|Adjusted by extent of DVT and clinical center|Numerator: PCDT Arm; Denominator: Control Arm||
1713887|NCT00790335|3153640|Superiority||Risk Ratio (RR)|0.94||||0.39|2-Sided|95.0|0.8|1.09|||Cochran-Mantel-Haenszel|Adjusted for thrombus extent and clinical center|No statistically significant difference was seen.||
1713888|NCT00790335|3153641|Superiority||Risk Ratio (RR)|0.58||||0.38|2-Sided|95.0|0.17|1.98|||Cochran-Mantel-Haenszel|Adjusted by extent of thrombus and clinical center|Numerator: PCDT Arm; Denominator: Control Arm. No statistically significant difference was seen.||
1713889|NCT00790335|3153642|Superiority||Risk Ratio (RR)|0.96||||0.56|2-Sided|95.0|0.82|1.11|||Cochran-Mantel-Haenszel|Adjusted for extent of DVT and for clinical center|Numerator: PCDT Arm; Denominator: Control Arm. Primary outcome = no statistically significant difference between the two arms.||
1713890|NCT00790205|3153653|Superiority or Other||Hazard Ratio (HR)|0.72|||<|0.001|2-Sided|95.0|0.68|0.77|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.|||
1713891|NCT00790205|3153654|Superiority or Other||Hazard Ratio (HR)|0.7|||<|0.001|2-Sided|95.0|0.65|0.75|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.|||
1713892|NCT00790205|3153655|Superiority or Other||Hazard Ratio (HR)|0.7|||<|0.001|2-Sided|95.0|0.63|0.79|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.|||
1713893|NCT00790205|3153656|Superiority or Other||Hazard Ratio (HR)|0.69|||<|0.001|2-Sided|95.0|0.61|0.77|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.|||
1713894|NCT00790205|3153663|Superiority or Other||Hazard Ratio (HR)|1.0||||0.983|2-Sided|95.0|0.83|1.2|||Cox proportional hazards model|Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.|
1713895|NCT00790205|3153664|Superiority or Other||Hazard Ratio (HR)|0.98||||0.858|2-Sided|95.0|0.81|1.19|||Cox proportional hazards model|Model stratified by region with treatment group and history of CHF at baseline as explanatory variables.||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in CHF cases requiring hospitalization was assessed by the hazard ratio between the Sitagliptin and Placebo groups.|
1713896|NCT00790205|3153665|Superiority or Other||Hazard Ratio (HR)|1.01||||0.875|2-Sided|95.0|0.9|1.14|||Cox proportional hazards model|||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.|
1713897|NCT00790205|3153666|Superiority or Other||Hazard Ratio (HR)|1.06||||0.435|2-Sided|95.0|0.91|1.24|||Cox proportional hazards model|||Hazard Ratio of Sitagliptin/Placebo: The between-treatment difference in mortality due to all causes was assessed by the hazard ratio between the Sitagliptin and Placebo groups.|
1713898|NCT00790205|3153667|Non-Inferiority or Equivalence|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.99|||<|0.001|2-Sided|95.0|0.89|1.1|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.|||
1713899|NCT00790205|3153668|Non-Inferiority or Equivalence|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.99|||<|0.001|2-Sided|95.0|0.89|1.11|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.|||
1713900|NCT00790205|3153669|Non-Inferiority or Equivalence|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.98|||<|0.001|2-Sided|95.0|0.89|1.08|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.|||
1713901|NCT00790205|3153670|Non-Inferiority or Equivalence|Hazard Ratio of Sitagliptin/Placebo: the between-treatment difference in time to the first primary composite CV outcome measure was assessed by the hazard ratio between the sitagliptin and placebo groups. The confidence interval for the hazard ratio was computed and compared to 1.30, the non-inferiority margin.|Hazard Ratio (HR)|0.98|||<|0.001|2-Sided|95.0|0.88|1.09|||Cox proportional hazards model|Model stratified by region with treatment group only as explanatory variable.|||
1713902|NCT00790192|3153671|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis||||
1713903|NCT00790192|3153672|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis||||
1713904|NCT00790062|3153680|Superiority or Other||Risk Ratio (RR)|1.0||||0.67|2-Sided|95.0|0.63|1.59|||ANCOVA||||
1713905|NCT00790036|3153688|Superiority or Other||Hazard Ratio (HR)|0.66|||||2-Sided|95.0|0.41|1.07|||||||
1713906|NCT00790036|3153689|Superiority or Other||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.52|1.09|||||||
1713907|NCT00790036|3153690|Superiority or Other||Hazard Ratio (HR)|0.92||||0.276|2-Sided|95.0|0.69|1.22||P-value was obtained from the one-sided unstratified log rank test.|Log Rank||||
1713908|NCT00790023|3153716|Superiority or Other||Mean Difference (Final Values)|0.6||||0.0005|2-Sided|95.0|0.27|0.94|||ANCOVA|||Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons|
1713909|NCT00790023|3153716|Superiority or Other||Mean Difference (Final Values)|0.61||||0.0004|2-Sided|95.0|0.28|0.95|||ANCOVA|||Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons|
1713910|NCT00790023|3153717|Superiority or Other||Mean Difference (Final Values)|1.0|||<|0.0001|2-Sided|95.0|0.63|1.37|||ANCOVA|||Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons|
1713911|NCT00790023|3153717|Superiority or Other||Mean Difference (Final Values)|0.87|||<|0.0001|2-Sided|95.0|0.5|1.25|||ANCOVA|||Dmitrienko’s tree-structured gatekeeping method was used for multiple comparisons|
1714000|NCT00789074|3153912|Superiority or Other||||||<|0.04||||||F=2.92|ANOVA|Changes were compared using repeated measures analysis of variance|||
1714001|NCT00789074|3153913|Superiority or Other||||||<|0.001||||||F=16.60|ANOVA|Changes were compared using repeated measures analysis of variance|||
1714002|NCT00789074|3153914|Superiority or Other||||||<|0.001|||||||ANOVA|Changes were compared using repeated measures analysis of variance|||
1713912|NCT00790023|3153718|Superiority or Other||Mean Difference (Final Values)|1.08|||<|0.0001|2-Sided|95.0|0.7|1.45||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.|
1713913|NCT00790023|3153718|Superiority or Other||Mean Difference (Final Values)|0.94|||<|0.0001|2-Sided|95.0|0.57|1.32||The p-value from primary outcome was adjusted at alpha=0.025.|ANCOVA|||The null hypothesis is that there is no difference in primary outcome when compare active to placebo group. The alternative hypothesis is that there is a difference in primary outcome when compare active to placebo group. It was estimated that 200 subjects per group will provide at least 85% power to detect a difference between treatment groups of 0.7 in the change from baseline in rTNSS with a two-sided alpha level of 0.025.|
1713914|NCT00789880|3153728|Superiority or Other|||||||0.3||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.|
1713915|NCT00789880|3153728|Superiority or Other|||||||0.2||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in lesional skin of psoriatic participants differs by treatment group.|
1713916|NCT00789880|3153729|Superiority or Other|||||||0.7||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.|
1713917|NCT00789880|3153730|Superiority or Other|||||||0.5||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in non-lesional skin of AD participants differs by treatment group.|
1713918|NCT00789880|3153730|Superiority or Other|||||||0.2||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in IL-13 mRNA expression in lesional skin of AD participants differs by treatment group.|
1713919|NCT00789880|3153731|Superiority or Other|||||||1||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.|
1713920|NCT00789880|3153731|Superiority or Other|||||||0.4||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in lesional skin of psoriatic participants differs by treatment group.|
1713921|NCT00789880|3153732|Superiority or Other|||||||0.4||||||P-value is not adjusted for multiple comparisons.|ANOVA|||Testing whether change in HBD-3 mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.|
1713922|NCT00789880|3153733|Superiority or Other|||||||0.2|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in HBD-3 mRNA expression in non-lesional skin of AD participants differs by treatment group.|
1713923|NCT00789880|3153733|Superiority or Other|||||||0.8|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in HBD-3 mRNA expression in lesional skin of AD participants differs by treatment group.|
1713924|NCT00789880|3153734|Superiority or Other|||||||0.2|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in CAMP mRNA expression in non-lesional skin of psoriatic participants differs by treatment group.|
1713925|NCT00789880|3153734|Superiority or Other|||||||0.4|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether change in CAMP mRNA expression in lesional skin of psoriatic participants differs by treatment group.|
1713926|NCT00789880|3153735|Superiority or Other|||||||0.3|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP mRNA expression in non-lesional skin of Non-AD participants differs by treatment group.|
1713927|NCT00789880|3153736|Superiority or Other|||||||0.12|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP mRNA expression in non-lesional skin of AD participants differs by treatment group.|
1713928|NCT00789880|3153736|Superiority or Other|||||||0.7|||||||ANOVA|P-value is not adjusted for multiple comparisons.||Testing whether the change in CAMP expression in lesional skin of AD participants differs by treatment group.|
1713929|NCT00789867|3153737|Other|||||||0.003|||||||Kruskal-Wallis||||
1713930|NCT00789867|3153738|Other|||||||0.22|||||||Kruskal-Wallis||||
1713931|NCT00789867|3153739|Other|||||||0.08|||||||Kruskal-Wallis||||
1713932|NCT00789867|3153740|Other|||||||0.06|||||||Kruskal-Wallis||||
1713933|NCT00789867|3153741|Other|||||||0.22|||||||Kruskal-Wallis||||
1713934|NCT00789867|3153742|Other|||||||0.0002|||||||Kruskal-Wallis||||
1713935|NCT00789854|3153771|Superiority or Other|||||||0.4368||||||Adjustment for multiplicity was done, alpha = 0.025|ANCOVA|Superiority testing of primary outcome showed no significant difference in the Modified Intention To Treat (ITT) population||The null hypothesis was that the quetiapine XR mono treatment was not different from the add-on lithium treatment. The power calculation was done for the primary non-inferior analysis. This superiority analysis was only done if the non-inferior analysis was successful.|
1713936|NCT00789854|3153771|Superiority or Other|||||||0.0489||||||Adjustment for multiplicity was done, alpha = 0.025|ANCOVA|Superiority testing of primary outcome showed no significant difference in the Modified Intention To Treat (ITT) population||The null hypothesis was that the add-on quetiapine XR treatment was not different to the add-on lithium treatment. The power calculation was done for the primary non-inferior analysis. This superiority analysis was only done if the non-inferior analysis was successful.|
1713937|NCT00789854|3153772|Non-Inferiority or Equivalence|"The non-inferiority margin for differences was set to 3 units in the MADRS total score.~A power set to 80% and using a Bonferroni-adjusted one-sided alpha* = alpha/3 = 0.0083 yields a planned sample size of 192 patients per study group. With a drop out of 4% a total of 600 randomized patients were required to obtain 192 efficacy evaluable patients per treatment group."|Mean Difference (Final Values)|-1.639||||||97.5|-3.24|1.312||||||Quetiapine XR mono was tested versus add-on lithium for non-inferiority. The null hypothesis was that the quetiapine XR mono treatment was non-inferior to add-on lithium.|
1714003|NCT00789074|3153915|Superiority or Other|||||||0.14|||||||ANOVA||||
1714980|NCT00774397|3155855|Superiority or Other||||||<|0.0537||||||P-value based on Fisher’s exact test (2-sided)|Fisher Exact||||
1713938|NCT00789854|3153772|Non-Inferiority or Equivalence|"The non-inferiority margin for differences was set to 3 units in the MADRS total score.~A power set to 80% and using a Bonferroni-adjusted one-sided alpha* = alpha/3 = 0.0083 yields a planned sample size of 192 patients per study group. With a drop out of 4% a total of 600 randomized patients were required to obtain 192 efficacy evaluable patients per treatment group."|Mean Difference (Final Values)|-2.322||||||97.5|-4.6|-0.05||||||Add-on quetiapine XR was tested versus add-on lithium for non-inferiority. The null hypothesis was that the add-on quetiapine treatment was non-inferior to add-on lithium.|
1713939|NCT00789815|3153784|Superiority or Other|||||||0.05|||||||Chi-squared||||
1713940|NCT00789815|3153785|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1713941|NCT00789815|3153786|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the global tolerance of patients in study is worse than that in the control group.|
1713942|NCT00789815|3153787|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1713943|NCT00789815|3153788|Superiority or Other|||||||0.05|||||||Chi-squared||||
1713944|NCT00789815|3153789|Superiority or Other|||||||0.05|||||||Chi-squared||||
1713945|NCT00789815|3153790|Superiority or Other|||||||0.05|||||||Chi-squared|||The null hypothesis: the incidence of hypotension during FB in patients of study group is higher than that in the control group.|
1713946|NCT00789815|3153791|Non-Inferiority or Equivalence|A preliminary study was performed to determine the sample size before this trial. 15 and 15 patients undergoing FB received BIS-guided propofol sedation and clinical-judged midazolam sedation, respectively. The incidences of hypoxemia were 0.33 and 0.20, respectively. The selected sample size of 225 in each group will yield 90% power for detecting a clinically meaningful difference of 0.13 at the 5.0% level of significance. To allow for 10% missing data, we recruited 250 patients per group.||||||0.05|||||||Chi-squared|||"The null hypothesis: the incidence of hypoxemia occured during FB with BIS-guided propofol infusion is higher than that with clinical-judged midazolam administration.~Power calculation is described below."|
1713947|NCT00789802|3153795|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1713948|NCT00789802|3153795|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1713949|NCT00789750|3153803|Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.73||0.8862|2-Sided|95.0|-1.5|1.3|||ANCOVA|||Treatment difference = Colesevelam - Placebo|
1713950|NCT00789750|3153804|Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.11||0.0653|2-Sided|95.0|-0.4|0.0|||ANCOVA|||Treatment difference = Colesevelam - Placebo|
1713951|NCT00789750|3153805|Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|1.77||0.7286|2-Sided|95.0|-4.1|2.9|||ANCOVA|||Treatment difference = Colesevelam - Placebo|
1713952|NCT00789750|3153806|Other||Mean Difference (Final Values)|-8.8|Standard Error of the Mean|1.52|<|0.0001|2-Sided|95.0|-11.75|-5.78|||ANCOVA|||Treatment difference = Colesevelam - Placebo|
1713953|NCT00789750|3153807|Other||Mean Difference (Final Values)|3.4|Standard Error of the Mean|0.93||0.0003|2-Sided|95.0|1.58|5.23|||ANCOVA|||Treatment difference = Colesevelam - Placebo|
1713954|NCT00789750|3153808|Other||Median Difference (Final Values)|11.3|Standard Error of the Mean|67.01||0.0004|2-Sided|95.0|5.3|17.5|||ANCOVA||The treatment difference and its 95% confidence interval are estimated using the Hodges-Lehmann estimator and Moses method. The parameter dispersion Type is actually IQR of the Median Difference.|Treatment difference = Colesevelam - Placebo|
1713955|NCT00789750|3153809|Other||Mean Difference (Final Values)|-9.8|Standard Error of the Mean|1.85|<|0.0001|2-Sided|95.0|-13.44|-6.16|||ANCOVA|||Treatment difference = Colesevelam - Placebo|
1713956|NCT00789750|3153810|Other||Mean Difference (Final Values)|1.8|Standard Error of the Mean|1.31||0.1652|2-Sided|95.0|-0.75|4.39|||ANCOVA|||Treatment difference = Colesevelam - Placebo|
1713957|NCT00789750|3153811|Other||Mean Difference (Final Values)|-16.4|Standard Error of the Mean|2.15|<|0.001|2-Sided|95.0|-20.62|-12.18|||ANCOVA|||Treatment difference = Colesevelam - Placebo|
1713958|NCT00789750|3153812|Other||||||<|0.001|||||||ANCOVA||||
1713959|NCT00789750|3153813|Other|||||||0.132|||||||Cochran-Mantel-Haenszel||||
1713960|NCT00789750|3153814|Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1713961|NCT00789750|3153815|Other|||||||0.0003|||||||Cochran-Mantel-Haenszel||||
1713962|NCT00789750|3153816|Other||Mean Difference (Final Values)|-14.7|Standard Error of the Mean|3.68|<|0.0001|2-Sided|95.0|-21.93|-7.49|||ANCOVA|||Treatment difference = Colesevelam - Placebo|
1713963|NCT00789750|3153817|Other|||||||0.012|||||||Cochran-Mantel-Haenszel||||
1713964|NCT00789750|3153818|Other||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|0.077|<|0.001|2-Sided|95.0|-0.51|-0.2|||ANCOVA|||Treatment difference = Colesevelam - Placebo|
1713965|NCT00789750|3153819|Other||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.056||0.0002|2-Sided|95.0|-0.32|-0.1|||ANCOVA|||Treatment difference = Colesevelam - Placebo|
1713966|NCT00789750|3153820|Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.037|<|0.001|2-Sided|95.0|-0.24|-0.1|||ANCOVA|||Treatment difference = Colesevelam - Placebo|
1713967|NCT00789750|3153821|Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.084|<|0.001|2-Sided|95.0|-0.49|-0.16|||ANCOVA|||Treatment difference = Colesevelam - Placebo|
1713968|NCT00789737|3153828|Superiority or Other||||||<|1e-05|||||||ANCOVA||||
1713969|NCT00789737|3153833|Superiority or Other|||||||0.0373|||||||ANCOVA||||
1713970|NCT00789737|3153834|Superiority or Other|||||||0.0369|||||||ANCOVA|||least squares mean; 80% power to detect a 0.3% change|
1713971|NCT00789724|3153843|Superiority or Other|||||||0.033|||||||ANOVA||||
1713972|NCT00789698|3153847|Non-Inferiority or Equivalence|This is a non-inferiority analysis. Lurasidone will be declared as effective as quetiapine XR in preventing relapse if the upper bound of a 2-sided 95% confidence limit for the hazard ration of lurasidone vs. quetiapine is no greater than an equivalence hazard ratio margin of 1.93.|Hazard Ratio (HR)|0.728|||||2-Sided|95.0|0.41|1.295||||||Comparison of time to relapse of psychotic symptoms between LUR-LUR and QXR-QXR as analyzed using the Cox proportional-hazards model.|
1713973|NCT00789672|3153856|Superiority or Other||Mean Difference (Final Values)|-2.0|Standard Deviation|4.7|||2-Sided|95.0|-6.0|1.0||||||Given this was pilot study, no formal sample size estimates were calculated.|
1713974|NCT00789373|3153887|Superiority or Other||Hazard Ratio (HR)|0.78||||0.0195|2-Sided|95.0|0.64|0.96||The predefined alpha for the final analysis of OS is 0.0498 for the unadjusted log-rank test.|Log Rank||Unadjusted HR from Cox model with treatment as the only cofactor.|Type 1 (alpha) error was controlled for the analyses of both PFS and OS in order to maintain an overall two-sided alpha level of 0.05 using a statistical gatekeeping and alpha spending scheme. The unconditional statistical power of the final OS analysis was 93%.|
1713975|NCT00789373|3153888|Superiority or Other||Hazard Ratio (HR)|0.64||||0.0002|2-Sided|95.0|0.51|0.81|||Log Rank||||
1713976|NCT00789373|3153889|Superiority or Other||Hazard Ratio (HR)|0.62||||6e-05|2-Sided|95.0|0.49|0.79|||Log Rank|||900 patients were planned to be enrolled in order to randomize 558 pts to maintenance therapy. This trial was powered for the primary endpoint, PFS (90% power, assuming 238 events with 52% censoring and a PFS Hazard Ratio (HR)=0.65, alpha=0.05). This trial was also powered for a secondary endpoint, OS (93% power, assuming 390 events with 30% censoring and an OS HR=0.70). Alpha was controlled for both a preliminary analysis (alpha=0.0001) and final analysis of OS (alpha=0.0499).|
1713977|NCT00789360|3153890|Other||Maximum LS mean change difference|-0.154|||||2-Sided|90.0|-0.29|-0.019|||||Greatest difference occurred at 9 hours after Dose 1||
1713978|NCT00789360|3153891|Other||Maximum LS mean change difference|0.0917|||||2-Sided|90.0|-0.028|0.212|||||Maximum difference occurred at 10 hours|The largest treatment difference (Loxapine - Placebo) in change in FEV1 from baseline by spirometry|
1713979|NCT00789321|3153892|Superiority or Other||Least Squares Mean|39.0||||0.001||95.0|17.9|60.1|||ANCOVA|Change from baseline in systolic blood pressure included as covariate|||
1713980|NCT00789321|3153893|Superiority or Other||Least Squares Mean|-11.7||||0.001||90.0|-18.1|-5.4|||ANCOVA|Change from baseline in systolic blood pressure included as covariate|||
1713981|NCT00789191|3153897|Superiority or Other||Mean Difference (Final Values)|-1.8||||||95.0|-2.26|-1.34|||||COMB-SITA Difference. Before breakfast the following day||
1713982|NCT00789191|3153897|Superiority or Other||Mean Difference (Final Values)|-1.17||||||95.0|-1.84|-0.49|||||COMB-SITA Difference. At 03:00 a.m.||
1713983|NCT00789191|3153897|Superiority or Other||Mean Difference (Final Values)|-1.04||||||95.0|-1.88|-0.2|||||COMB-SITA Difference. Bedtime||
1713984|NCT00789191|3153897|Superiority or Other||Median Difference (Final Values)|-0.88||||||95.0|-1.75|-0.02|||||COMB-SITA Difference. 120 minutes after start of dinner||
1713985|NCT00789191|3153897|Superiority or Other||Median Difference (Final Values)|-0.77||||||95.0|-1.58|0.05|||||COMB-SITA Difference. Before dinner||
1713986|NCT00789191|3153897|Superiority or Other||Mean Difference (Final Values)|-1.3||||||95.0|-2.05|-0.56|||||COMB-SITA Difference. 120 minutes after start of lunch||
1713987|NCT00789191|3153897|Superiority or Other||Mean Difference (Final Values)|-1.02||||||95.0|-1.69|-0.35|||||COMB-SITA Difference. Before lunch||
1713988|NCT00789191|3153897|Superiority or Other||Mean Difference (Final Values)|-1.64||||||95.0|-2.4|-0.89|||||COMB-SITA Difference. 120 minutes after start of breakfast||
1713989|NCT00789191|3153897|Superiority or Other||Mean Difference (Final Values)|-2.01||||||95.0|-2.5|-1.51|||||COMB-SITA Difference. Before breakfast||
1713990|NCT00789191|3153901|Superiority or Other||Mean Difference (Final Values)|-2.45||||0.001||95.0|-3.01|-1.88||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.|||
1713991|NCT00789191|3153902|Superiority or Other||Mean Difference (Final Values)|0.84||||0.109||95.0|-0.19|1.88||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.|||
1713992|NCT00789191|3153903|Superiority or Other||Mean Difference (Final Values)|0.28||||0.121||95.0|-0.07|0.63||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p<0.05.|ANCOVA|An analysis of covariance (ANCOVA) was used; baseline was included as covariate and treatment, stratification and country was included as factors.|||
1713993|NCT00789191|3153904|Superiority or Other||Odds Ratio (OR)|2.07||||0.135||95.0|0.8|5.37||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p<0.05.|Regression, Logistic||Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate|Null hypothesis: Odds ratio is equal to one.|
1713994|NCT00789191|3153905|Superiority or Other||Odds Ratio (OR)|2.23||||0.063||95.0|0.96|5.2||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.|
1713995|NCT00789191|3153906|Superiority or Other||Odds Ratio (OR)|2.47||||0.008||95.0|1.26|4.81||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.|
1713996|NCT00789191|3153907|Superiority or Other||Odds Ratio (OR)|3.2||||0.001||95.0|1.65|6.19||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p<0.05.|Regression, Logistic|Treatment group comparison using logistic regression model incl.treatment,stratification factor, country as fixed effects, baseline HbA1c as covariate||Null hypothesis: Odds ratio is equal to one.|
1713997|NCT00789191|3153908|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.001||95.0|-0.77|-0.33||No corrections to adjust for multiplicity were performed. Statistical significance threshold was p<0.05.|ANCOVA|Analysis of covariance (ANCOVA) was used; baseline HbA1c was included as covariate and treatment, stratification and country was included as factors||Null hypothesis: Difference between mean HbA1c in the two treatment arms is equal to zero. Power calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%|
1713998|NCT00789074|3153910|Superiority or Other|||||||0.97|||||||ANOVA|Changes were compared using repeated measures analysis of variance|||
1713999|NCT00789074|3153911|Superiority or Other|||||||0.02|||||||ANOVA|Changes were compared using repeated measures analysis of variance|||
1714004|NCT00789035|3153925|Superiority or Other||Mean Difference (Final Values)|-0.72|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-0.94|-0.5||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 25mg minus placebo||
1714005|NCT00789035|3153925|Superiority or Other||Mean Difference (Final Values)|-0.57|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-0.8|-0.35||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 10mg minus placebo||
1714006|NCT00789035|3153925|Superiority or Other||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.11|<|0.0001|2-Sided|95.0|-0.74|-0.29||No formal testing so adjustment for multiple comparisons was not necessary.|ANCOVA|Based on ANCOVA with terms for baseline, treatment, number of previous anti-diabetic medications and country.|Difference calculated as empa 5mg minus placebo||
1714007|NCT00788957|3153938|Superiority or Other||Difference in median time|1.5|||||2-Sided|95.0|-1.7|2.9|||||||
1714008|NCT00788957|3153938|Superiority or Other||Difference in median time|1.5|||||2-Sided|95.0|-0.3|2.8|||||||
1714009|NCT00788957|3153939|Superiority or Other||Difference in median time|1.5|||||2-Sided|95.0|-1.6|2.9|||||||
1714010|NCT00788957|3153939|Superiority or Other||Difference in median time|1.5|||||2-Sided|95.0|-0.6|2.8|||||||
1714011|NCT00788957|3153940|Superiority or Other||Risk Difference (RD)|5.0|||||2-Sided|95.0|-16.0|25.0|||||||
1714012|NCT00788957|3153940|Superiority or Other||Risk Difference (RD)|15.0|||||2-Sided|95.0|-6.0|34.0|||||||
1714013|NCT00788957|3153943|Superiority or Other||Posterior Mean odds ratio (OR)|1.281||||0.6336|2-Sided|95.0|0.478|2.726|||Posterior probability of OR > 1||An odds ratio value greater than 1 implies a higher ORR for the respective combination therapy relative to panitumumab alone.|The posterior distribution of the odds ratio for an ORR was used to assess whether rilotumumab and/or ganitumab in combination with panitumumab has a higher ORR compared to panitumumab alone. A 95% credible region was calculated for the odds ratio. The posterior probability of the odds ratio being > 1 is reported as the P-value.|
1714014|NCT00788957|3153943|Superiority or Other||Posterior Mean odds ratio (OR)|2.003||||0.9318|2-Sided|95.0|0.84|4.243|||Posterior probability of OR > 1||An odds ratio value greater than 1 implies a higher ORR for the respective combination therapy relative to panitumumab alone.|"The posterior distribution of the odds ratio for an ORR was used to assess whether rilotumumab and/or ganitumab in combination with panitumumab has a higher ORR compared to panitumumab alone. A 95% credible region was calculated for the odds ratio.~The posterior probability of the odds ratio being > 1 is reported as the P-value."|
1714015|NCT00788957|3153943|Superiority or Other||Posterior Mean Difference in ORR|2.5|||||2-Sided|95.0|-10.6|16.4||||||The posterior mean difference in ORR and the 95% credible region for the difference in the ORR between panitumumab + ganitumab compared to panitumumab alone.|
1714016|NCT00788957|3153943|Superiority or Other||Posterior Mean Difference in ORR|10.9|||||2-Sided|95.0|-2.9|26.2||||||The posterior mean difference in ORR and the 95% credible region for the difference in the ORR between panitumumab + rilotumumab compared to panitumumab alone.|
1714017|NCT00788957|3153943|Superiority or Other||Posterior Mean|21.1|||||2-Sided|95.0|11.3|32.9||||||For the primary analysis of objective response rate (ORR) for Part 2, a Beta(6.3, 33.7) and Beta(1.1, 5.9) was used as priors for panitumumab alone and combination regimens in calculating the posterior distribution of the ORR for each respective treatment group. The posterior mean and 95% credible region are reported.|
1714018|NCT00788957|3153943|Superiority or Other||Posterior Mean|29.4|||||2-Sided|95.0|18.3|42.4||||||For the primary analysis of objective response rate (ORR) for Part 2, a Beta(6.3, 33.7) and Beta(1.1, 5.9) was used as priors for panitumumab alone and combination regimens in calculating the posterior distribution of the ORR for each respective treatment group. The posterior mean and 95% credible region are reported.|
1714019|NCT00788957|3153943|Superiority or Other||Posterior Mean|18.5|||||2-Sided|95.0|11.2|27.0||||||For the primary analysis of objective response rate (ORR) for Part 2, a Beta(6.3, 33.7) and Beta(1.1, 5.9) was used as priors for panitumumab alone and combination regimens in calculating the posterior distribution of the ORR for each respective treatment group. The posterior mean and 95% credible region are reported.|
1714020|NCT00788827|3153954|Other||||||<|0.05|||||||Mixed Models Analysis|||Each participants Hba1c (%) lab result was analysed pre and post stem cell infusion to achieve 2 mean readings per participant.|
1714021|NCT00788710|3153960|Superiority or Other||||||<|0.001|||||||ANOVA||||
1714022|NCT00788710|3153960|Superiority or Other||||||<|0.001|||||||ANOVA||||
1714023|NCT00788710|3153961|Superiority or Other||||||<|0.001|||||||ANOVA||||
1714024|NCT00788710|3153961|Superiority or Other||||||<|0.001|||||||ANOVA||||
1714025|NCT00788710|3153962|Superiority or Other||||||<|0.001|||||||ANOVA||||
1714026|NCT00788710|3153962|Superiority or Other||||||<|0.001|||||||ANOVA||||
1714027|NCT00788697|3153966|Superiority or Other|||||||0.761|||||||Wald Test||||
1714028|NCT00788697|3153966|Superiority or Other||||||<|0.0001|||||||Wald Test||||
1714029|NCT00788697|3153966|Superiority or Other||||||<|0.0001|||||||Wald Test||||
1714030|NCT00788697|3153967|Superiority or Other|||||||0.0004|||||||Wald Test||||
1714031|NCT00788697|3153967|Superiority or Other||||||<|0.0001|||||||Wald Test||||
1714032|NCT00788697|3153967|Superiority or Other||||||<|0.0001|||||||Wald Test||||
1714033|NCT00788697|3153968|Superiority or Other||Difference in Accuracy (%)|4.2||||0.3173|2-Sided|95.0|-4.0|12.3|||McNemar||||
1714034|NCT00788697|3153968|Superiority or Other||Difference in Accuracy (%)|39.2|||<|0.0001|2-Sided|95.0|31.3|47.1|||McNemar||||
1714035|NCT00788697|3153968|Superiority or Other||Difference in Accuracy (%)|28.8|||<|0.0001|2-Sided|95.0|20.5|37.0|||McNemar||||
1714036|NCT00788697|3153969|Superiority or Other||Difference in Specificity (%)|29.3|||<|0.0001|2-Sided|95.0|19.7|38.9|||McNemar||||
1714037|NCT00788697|3153969|Superiority or Other||Difference in Specificity (%)|60.3|||<|0.0001|2-Sided|95.0|50.5|70.2|||McNemar||||
1714038|NCT00788697|3153969|Superiority or Other||Difference in Specificity (%)|47.4|||<|0.0001|2-Sided|95.0|37.4|57.4|||McNemar||||
1714039|NCT00788697|3153970|Superiority or Other||Difference in Sensitivity (%)|-19.4||||0.0016|2-Sided|95.0|-30.9|-7.8|||McNemar||||
1714040|NCT00788697|3153970|Superiority or Other||Difference in Sensitivity (%)|19.4||||0.0011|2-Sided|95.0|8.3|30.5|||McNemar||||
1714041|NCT00788697|3153970|Superiority or Other||Difference in Sensitivity (%)|11.3||||0.0754|2-Sided|95.0|-1.0|23.6|||McNemar||||
1714042|NCT00788593|3153973|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1714043|NCT00788593|3153973|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1714044|NCT00788593|3153974|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1714045|NCT00788593|3153974|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1714046|NCT00788593|3153975|Superiority or Other||Least Square (LS) Mean Difference|1.023||||0.228|2-Sided|95.0|-0.656|2.701|||ANCOVA|||Treatment difference and 95 percent (%) confidence interval (CI) was based on LS mean from analysis of covariance (ANCOVA) which included participant as random effect, treatment, period and sequence as fixed effects, and placebo baseline CFA value as covariate.|
1714047|NCT00788073|3154013|Superiority or Other||Mean Difference (Final Values)|1.0||||0.008||95.0|||||ANCOVA||||
1714048|NCT00788073|3154014|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.05|||||||ANCOVA||||
1714049|NCT00787930|3154017|Non-Inferiority or Equivalence|Exploratory analyses|t-stat estimated value|1.47|Standard Deviation|6.56||0.091|1-Sided|95.0|0.0|||no adjustment for multiple analyses|t-test, 1 sided|missing values: 5 df=7|||
1714050|NCT00787930|3154018|Non-Inferiority or Equivalence|Exploratory hypothesis|t-stat estimated value|1.52|Standard Deviation|8.2||0.081|1-Sided|95.0|0.0||||t-test, 1 sided|missing values: 6 df=7|||
1714051|NCT00787930|3154019|Superiority or Other|||||||0.6056||||||No adjustment for multiple comparisons|Chi-squared|df=1|||
1714052|NCT00787930|3154020|Superiority or Other|||||||1|||||||Chi-squared|df=1|||
1714053|NCT00787930|3154021|Superiority or Other||||||>|0.05||||||a priori threshold for significance was 0.05|Chi-squared||||
1714054|NCT00787800|3154042|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1714055|NCT00787800|3154044|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1714056|NCT00787800|3154046|Superiority or Other|||||||1|||||||Log Rank||||
1714057|NCT00787254|3154105|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1714058|NCT00787254|3154106|Superiority or Other|||||||0.4028|||||||Wilcoxon (Mann-Whitney)||||
1714059|NCT00787254|3154107|Superiority or Other|||||||0.2503|||||||Wilcoxon (Mann-Whitney)||||
1714060|NCT00787254|3154108|Superiority or Other|||||||0.1571|||||||Wilcoxon (Mann-Whitney)||||
1714061|NCT00787254|3154110|Superiority or Other|||||||0.4344|||||||t-test, 2 sided||||
1714062|NCT00787254|3154111|Superiority or Other|||||||0.3117|||||||Wilcoxon (Mann-Whitney)||||
1714063|NCT00787254|3154112|Superiority or Other|||||||0.7223|||||||Wilcoxon (Mann-Whitney)||||
1714064|NCT00787254|3154113|Superiority or Other|||||||0.5328|||||||Wilcoxon (Mann-Whitney)||||
1714065|NCT00787254|3154115|Superiority or Other|||||||0.1522|||||||Wilcoxon (Mann-Whitney)||||
1714066|NCT00787254|3154116|Superiority or Other|||||||0.7121|||||||Wilcoxon (Mann-Whitney)||||
1714067|NCT00787254|3154117|Superiority or Other|||||||0.3046|||||||Wilcoxon (Mann-Whitney)||||
1714068|NCT00787254|3154118|Superiority or Other|||||||0.0703|||||||Wilcoxon (Mann-Whitney)||||
1714069|NCT00787254|3154120|Superiority or Other|||||||0.2008|||||||Wilcoxon (Mann-Whitney)||||
1714070|NCT00787254|3154121|Superiority or Other|||||||0.9566|||||||Wilcoxon (Mann-Whitney)||||
1714071|NCT00787254|3154122|Superiority or Other|||||||0.7244|||||||Wilcoxon (Mann-Whitney)||||
1714072|NCT00787254|3154123|Superiority or Other|||||||0.8262|||||||Wilcoxon (Mann-Whitney)||||
1714073|NCT00787254|3154125|Superiority or Other|||||||0.7325|||||||Wilcoxon (Mann-Whitney)||||
1714074|NCT00787254|3154126|Superiority or Other|||||||0.0355|||||||Wilcoxon (Mann-Whitney)||||
1714075|NCT00787254|3154127|Superiority or Other|||||||0.4599|||||||Wilcoxon (Mann-Whitney)||||
1714076|NCT00787254|3154128|Superiority or Other|||||||0.698|||||||Wilcoxon (Mann-Whitney)||||
1714077|NCT00787254|3154130|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1714078|NCT00787254|3154131|Superiority or Other|||||||0.7794|||||||Wilcoxon (Mann-Whitney)||||
1714079|NCT00787254|3154132|Superiority or Other|||||||0.5099|||||||Wilcoxon (Mann-Whitney)||||
1714080|NCT00787254|3154133|Superiority or Other|||||||0.206|||||||Wilcoxon (Mann-Whitney)||||
1714081|NCT00787254|3154135|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1714082|NCT00787254|3154136|Superiority or Other|||||||0.8811|||||||Wilcoxon (Mann-Whitney)||||
1714083|NCT00787254|3154137|Superiority or Other|||||||0.6607|||||||Wilcoxon (Mann-Whitney)||||
1714084|NCT00787254|3154138|Superiority or Other|||||||0.4788|||||||Wilcoxon (Mann-Whitney)||||
1714085|NCT00787254|3154139|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1714086|NCT00787254|3154141|Superiority or Other|||||||0.2363|||||||Wilcoxon (Mann-Whitney)||||
1714087|NCT00787254|3154142|Superiority or Other|||||||0.0068|||||||Wilcoxon (Mann-Whitney)||||
1714088|NCT00787254|3154143|Superiority or Other|||||||0.0161|||||||Wilcoxon (Mann-Whitney)||||
1714089|NCT00787254|3154144|Superiority or Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)||||
1714090|NCT00787254|3154146|Superiority or Other|||||||0.9836|||||||Wilcoxon (Mann-Whitney)||||
1714091|NCT00787254|3154147|Superiority or Other|||||||0.0652|||||||Wilcoxon (Mann-Whitney)||||
1714092|NCT00787254|3154148|Superiority or Other|||||||0.0041|||||||Wilcoxon (Mann-Whitney)||||
1714093|NCT00787254|3154149|Superiority or Other|||||||0.0002|||||||Wilcoxon (Mann-Whitney)||||
1714094|NCT00787254|3154150|Superiority or Other||Hazard Ratio (HR)|0.251|||<|0.0001|2-Sided|95.0|0.14|0.4499|||Log Rank||||
1714095|NCT00787189|3154163|Superiority or Other (legacy)||||||<|0.0005|||||||Fisher Exact||||
1714096|NCT00786994|3154188|Superiority or Other|||||||0.83|||||||Mantel Haenszel|||B vs. C/D|
1714097|NCT00786994|3154188|Superiority or Other|||||||0.6|||||||Mantel Haenszel|||A vs C/D|
1714102|NCT00786799|3154209|Superiority or Other||Mean Difference (Net)|2.3|Standard Deviation|6.1||0.4|||||||t-test, 2 sided|||The null hypothesis is that the mean change in Aberrant Behavior Checklist Hyperactivity subscale (ABC-H) score is the same for both groups.|
1714103|NCT00786487|3154233|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1714104|NCT00786487|3154233|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1714105|NCT00786188|3154269|Superiority or Other|||||||0.0364||||||Week 8 severity|Reapeated measures analysis||||
1714106|NCT00786188|3154269|Superiority or Other|||||||0.0644||||||Week 4 severity|Reapeated measures analysis||||
1714107|NCT00786188|3154270|Superiority or Other|||||||0.0541||||||Week 8 frequency|Reapeated measures analysis||||
1714108|NCT00786188|3154270|Superiority or Other|||||||0.0177||||||Week 4 frequency|Repeated measures analysis||||
1714109|NCT00785928|3154284|Superiority or Other|||||||0.03||||||P-value for IgA. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714110|NCT00785928|3154284|Superiority or Other|||||||0.025||||||P-value for IgA. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714111|NCT00785928|3154284|Superiority or Other|||||||0.061||||||P-value for IgA. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714112|NCT00785928|3154284|Superiority or Other|||||||0.053||||||P-value for IgA. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714113|NCT00785928|3154284|Superiority or Other|||||||0.677||||||P-value for IgA. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714114|NCT00785928|3154284|Superiority or Other|||||||0.944||||||P-value for IgA. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714115|NCT00785928|3154284|Superiority or Other|||||||0.017||||||P-value for IgM. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714116|NCT00785928|3154284|Superiority or Other|||||||0.004||||||P-value for IgM. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714117|NCT00785928|3154284|Superiority or Other|||||||0.023||||||P-value for IgM. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714118|NCT00785928|3154284|Superiority or Other|||||||0.152||||||P-value for IgM. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714119|NCT00785928|3154284|Superiority or Other|||||||0.909||||||P-value for IgM. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714120|NCT00785928|3154284|Superiority or Other|||||||0.447||||||P-value for IgM. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714121|NCT00785928|3154284|Superiority or Other|||||||0.85||||||P-value for IgG. Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714122|NCT00785928|3154284|Superiority or Other|||||||0.34||||||P-value for IgG. Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714123|NCT00785928|3154284|Superiority or Other|||||||0.225||||||P-value for IgG. Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714124|NCT00785928|3154284|Superiority or Other|||||||0.882||||||P-value for IgG. Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714125|NCT00785928|3154284|Superiority or Other|||||||0.84||||||P-value for IgG. Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714126|NCT00785928|3154284|Superiority or Other|||||||0.901||||||P-value for IgG. Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with standardized rank outcome variable, treatment as the fixed factor, and standardized rank baseline value as a covariate.|ANCOVA||||
1714127|NCT00785928|3154285|Superiority or Other|||||||0.035||||||Pairwise (2-sided) comparisons of 120 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA||||
1714128|NCT00785928|3154285|Superiority or Other|||||||0.734||||||Pairwise (2-sided) comparisons of 60 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA||||
1714129|NCT00785928|3154285|Superiority or Other|||||||0.005||||||Pairwise (2-sided) comparisons of 30 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA||||
1714130|NCT00785928|3154285|Superiority or Other|||||||0.025||||||Pairwise (2-sided) comparisons of 10 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA||||
1714131|NCT00785928|3154285|Superiority or Other|||||||0.038||||||Pairwise (2-sided) comparisons of 3 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA||||
1714132|NCT00785928|3154285|Superiority or Other|||||||0.236||||||Pairwise (2-sided) comparisons of 1 mg LY2127399 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable treatment as the fixed factor and the standardized rank baseline value as a covariate.|ANCOVA||||
1714133|NCT00785928|3154288|Superiority or Other|||||||0.045||||||P-value for mental health component. Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA||||
1714134|NCT00785928|3154288|Superiority or Other|||||||0.821||||||P-value for mental health component. Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA||||
1714135|NCT00785928|3154288|Superiority or Other|||||||0.507||||||P-value for mental health component. Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA||||
1714136|NCT00785928|3154288|Superiority or Other|||||||0.647||||||P-value for mental health component. Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA||||
1714137|NCT00785928|3154288|Superiority or Other|||||||0.953||||||P-value for mental health component. Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA||||
1714138|NCT00785928|3154288|Superiority or Other|||||||0.569||||||P-value for mental health component. Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA||||
1714139|NCT00785928|3154288|Superiority or Other|||||||0.98||||||P-value for physical health component. Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA||||
1714140|NCT00785928|3154288|Superiority or Other|||||||0.01||||||P-value for physical health component. Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA||||
1714141|NCT00785928|3154288|Superiority or Other|||||||0.832||||||P-value for physical health component. Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA||||
1714142|NCT00785928|3154288|Superiority or Other|||||||0.304||||||P-value for physical health component. Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA||||
1714143|NCT00785928|3154288|Superiority or Other|||||||0.539||||||P-value for physical health component. Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA||||
1714144|NCT00785928|3154288|Superiority or Other|||||||0.562||||||P-value for physical health component. Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and baseline value as the covariate.|ANCOVA||||
1714145|NCT00785928|3154289|Superiority or Other|||||||0.037||||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA||||
1714146|NCT00785928|3154289|Superiority or Other|||||||0.243||||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA||||
1714147|NCT00785928|3154289|Superiority or Other|||||||0.127||||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA||||
1714148|NCT00785928|3154289|Superiority or Other|||||||0.091||||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA||||
1714149|NCT00785928|3154289|Superiority or Other|||||||0.826||||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA||||
1714150|NCT00785928|3154289|Superiority or Other|||||||0.833||||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as the covariate.|ANCOVA||||
1714151|NCT00785928|3154290|Superiority or Other|||||||0.456||||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA||||
1714152|NCT00785928|3154290|Superiority or Other|||||||0.317||||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA||||
1714153|NCT00785928|3154290|Superiority or Other|||||||0.242||||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA||||
1714154|NCT00785928|3154290|Superiority or Other|||||||0.143||||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA||||
1714155|NCT00785928|3154290|Superiority or Other|||||||0.085||||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA||||
1714156|NCT00785928|3154290|Superiority or Other|||||||0.952||||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using ranked analysis of covariance (ANCOVA) with the standardized rank outcome variable, treatment as the fixed factor, and the standardized rank baseline value as a covariate.|ANCOVA||||
1714157|NCT00785928|3154291|Superiority or Other|||||||0.472||||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714158|NCT00785928|3154291|Superiority or Other|||||||0.054||||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714159|NCT00785928|3154291|Superiority or Other|||||||0.646||||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714160|NCT00785928|3154291|Superiority or Other|||||||0.992||||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714161|NCT00785928|3154291|Superiority or Other|||||||0.575||||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714162|NCT00785928|3154291|Superiority or Other|||||||0.88||||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714163|NCT00785928|3154292|Superiority or Other|||||||0.012||||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714164|NCT00785928|3154292|Superiority or Other|||||||0.708||||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714165|NCT00785928|3154292|Superiority or Other|||||||0.266||||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714166|NCT00785928|3154292|Superiority or Other|||||||0.406||||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714167|NCT00785928|3154292|Superiority or Other|||||||0.352||||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714168|NCT00785928|3154292|Superiority or Other|||||||0.969||||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714169|NCT00785928|3154293|Superiority or Other|||||||0.073||||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714170|NCT00785928|3154293|Superiority or Other|||||||0.522||||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714171|NCT00785928|3154293|Superiority or Other|||||||0.737||||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714172|NCT00785928|3154293|Superiority or Other|||||||0.752||||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714173|NCT00785928|3154293|Superiority or Other|||||||0.311||||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714174|NCT00785928|3154293|Superiority or Other|||||||0.583||||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714826|NCT00778258|3155389|Superiority or Other|||||||0.32||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Tregs|
1714175|NCT00785928|3154294|Superiority or Other|||||||0.066||||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714176|NCT00785928|3154294|Superiority or Other|||||||0.893||||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714177|NCT00785928|3154294|Superiority or Other|||||||0.619||||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714178|NCT00785928|3154294|Superiority or Other|||||||0.549||||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714179|NCT00785928|3154294|Superiority or Other|||||||0.393||||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714180|NCT00785928|3154294|Superiority or Other|||||||0.746||||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714181|NCT00785928|3154295|Superiority or Other|||||||0.091||||||This p-value is from a 2-sided comparison of 120 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared||||
1714182|NCT00785928|3154295|Superiority or Other|||||||0.489||||||This p-value is from a 2-sided comparison of 60 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared||||
1714183|NCT00785928|3154295|Superiority or Other|||||||0.304||||||This p-value is from a 2-sided comparison of 30 mg LY2127399 versus placebo using a Chi-square test for the 3 levels of EULAR response (good, moderate, no).|Chi-squared||||
1714184|NCT00785928|3154295|Superiority or Other|||||||1||||||This p-value is from 2-sided comparison of 10 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact||||
1714185|NCT00785928|3154295|Superiority or Other|||||||1||||||This p-value is from 2-sided comparison of 3 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact||||
1714186|NCT00785928|3154295|Superiority or Other|||||||0.875||||||This p-value is from 2-sided comparison of 1 mg LY2127399 versus placebo using Fisher's exact test for the 3 levels of EULAR response (good, moderate, no).|Fisher Exact||||
1714187|NCT00785928|3154296|Superiority or Other|||||||0.048||||||Pairwise comparison (1-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714188|NCT00785928|3154296|Superiority or Other|||||||0.271||||||Pairwise comparison (1-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714189|NCT00785928|3154296|Superiority or Other|||||||0.357||||||Pairwise comparison (1-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714190|NCT00785928|3154296|Superiority or Other|||||||0.278||||||Pairwise comparison (1-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714191|NCT00785928|3154296|Superiority or Other|||||||0.874||||||Pairwise comparison (1-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714192|NCT00785928|3154296|Superiority or Other|||||||0.457||||||Pairwise comparison (1-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714193|NCT00785928|3154297|Superiority or Other|||||||0.133||||||Pairwise comparison (2-sided) of 120 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714194|NCT00785928|3154297|Superiority or Other|||||||0.944||||||Pairwise comparison (2-sided) of 60 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714195|NCT00785928|3154297|Superiority or Other|||||||0.645||||||Pairwise comparison (2-sided) of 30 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714196|NCT00785928|3154297|Superiority or Other|||||||0.367||||||Pairwise comparison (2-sided) of 10 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714197|NCT00785928|3154297|Superiority or Other|||||||0.696||||||Pairwise comparison (2-sided) of 3 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714198|NCT00785928|3154297|Superiority or Other|||||||0.671||||||Pairwise comparison (2-sided) of 1 mg LY2123799 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714199|NCT00785928|3154298|Superiority or Other|||||||0.289||||||Pairwise comparison (2-sided) of 120 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714200|NCT00785928|3154298|Superiority or Other|||||||0.754||||||Pairwise comparison (2-sided) of 60 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714201|NCT00785928|3154298|Superiority or Other|||||||0.633||||||Pairwise comparison (2-sided) of 30 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714202|NCT00785928|3154298|Superiority or Other|||||||0.568||||||Pairwise comparison (2-sided) of 10 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714203|NCT00785928|3154298|Superiority or Other|||||||0.16||||||Pairwise comparison (2-sided) of 3 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714204|NCT00785928|3154298|Superiority or Other|||||||0.623||||||Pairwise comparison (2-sided) of 1 mg LY2127399 versus placebo using contrast statements within an analysis of covariance (ANCOVA) model with treatment as the fixed factor and the baseline value as a covariate.|ANCOVA||||
1714205|NCT00785928|3154299|Superiority or Other||ED95|118.5||||0.005||95.0||||This p-value is for estimated dose level of the smallest dose, in milligrams (mg), that achieves at least 95% of the maximal efficacy (ED95) of the ACR20 and is based on the comparisons that the ED95 yields a higher fitted response rate than placebo.|Linear-quadratic regression model|This is the ED95 in mg.|||
1714206|NCT00785928|3154299|Superiority or Other|||||||0.044||||||This is the p-value for the fitted ACR20 response rate and is based on the dose-response regression model and comes from the joint test of linear and quadratic dose response (response=dose+dose^2) from the likelihood ratio test.|Linear-quadratic regression model||||
1714207|NCT00785928|3154300|Superiority or Other||ED95|119.0||||0.042||95.0||||This is the p-value for the estimated dose level of the smallest dose, in milligrams (mg), that achieves at least 95% of the maximal efficacy (ED95) and is based on the comparisons that the ED95 yields a higher fitted response rate than placebo.|Linear-quadratic regression model|This is ED95 in mg.|||
1714208|NCT00785928|3154300|Superiority or Other|||||||0.059||||||This is p-value for the fitted ACR50 response rate and is based on the dose-response regression model and comes from the joint test of linear and quadratic dose response (response=dose+dose^2) from the likelihood ratio test.|Linear-quadratic regression model||||
1714209|NCT00785785|3154303|Superiority or Other||Hazard Ratio (HR)|1.466||||0.0081|2-Sided|95.0|1.104|1.945|||Hazard Ratio||||
1714210|NCT00785291|3154353|Superiority or Other (legacy)||Hazard Ratio (HR)|1.28||||0.038|2-Sided|95.0|1.01|1.61||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).|Log Rank||||
1714211|NCT00785291|3154353|Superiority or Other (legacy)||Hazard Ratio (HR)|1.17||||0.2|2-Sided|95.0|0.92|1.47||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).|Log Rank||||
1714212|NCT00785291|3154357|Superiority or Other (legacy)||Hazard Ratio (HR)|1.55|||<|0.0001|2-Sided|95.0|1.28|1.87||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.|Log Rank|||Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.|
1714213|NCT00785291|3154357|Superiority or Other (legacy)||Hazard Ratio (HR)|1.2|||<|0.054|2-Sided|95.0|1.0|1.45||Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.|Log Rank|||Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.|
1714214|NCT00785044|3154361|Superiority or Other|Analysis was performed using the null hypothesis for the AUC stated as: H0: θ ≤A versus H1: θ >A, where the AUC (θ) value was: ‘A’ selected based on the diagnostic utility desired from the use of myocardial 123 I-mIBG uptake measured using H/M ratio. A smooth parametric model of the ROC curve was fitted to the data. The AUC for the resulting model was calculated and 95% confidence interval for the AUC was reported. The hypothesis was tested using the Z-statistics at ‘A’ at level of 0.70.|Mean|0.581|||<|0.001|2-Sided|95.0|0.532|0.63||At 0.05 level of significance.|Z-statistic|||"Analysis was performed on all HF participants from both groups AdreView™ - HF Group (With No Adverse Cardiac Events) and AdreView™ - HF Group (With Adverse Cardiac Events) based on H/M ratio."|
1714215|NCT00784810|3154401|Non-Inferiority or Equivalence|As above.|Mean Difference (Net)|0.44|Standard Error of the Mean|1.19||0.002|1-Sided|90.0|-5.65||||Mixed Models Analysis|||To achieve a study with 80% power at the 1-sided 5% significance level, for the purposes of demonstrating non inferiority, a sample size of 98 subjects per treatment group was required, i.e. a total of 196 subjects completing the study.|
1714216|NCT00784784|3154402|Superiority or Other||Odds Ratio (OR)|0.23||||0.25|2-Sided|95.0|0.01|4.8|||Fisher Exact|||That in a year with mismatch between influenza vaccine antigen and infecting H3N2 strain, seasonal (10-13 weeks) antiviral prophylaxis in adults will provide better protection from symptomatic influenza infection than trivalent inactivated split virus influenza vaccine.|
1714217|NCT00784719|3154439|Superiority or Other||Median|16.0|||||2-Sided|80.0|15.0|30.0|||||||
1714218|NCT00784719|3154439|Superiority or Other||Median|15.0|||||2-Sided|80.0|8.0|43.0|||||||
1714219|NCT00784719|3154439|Superiority or Other||Median|9.0|||||2-Sided|80.0|8.0|15.0|||||||
1714220|NCT00784719|3154439|Superiority or Other||Median|9.5|||||2-Sided|80.0|8.0|15.0|||||||
1714221|NCT00784719|3154439|Superiority or Other||Median|15.0|||||2-Sided|80.0|15.0|27.0|||||||
1714222|NCT00784719|3154439|Superiority or Other||Median|8.5|||||2-Sided|80.0|8.0|27.0|||||||
1714223|NCT00784719|3154439|Superiority or Other||Median|15.0|||||2-Sided|80.0|9.0|28.0|||||||
1714827|NCT00778258|3155389|Superiority or Other|||||||0.59|||||||Kruskal-Wallis|||Analysis on Tregs|
1714224|NCT00784719|3154441|Superiority or Other||Median|57.0|||||2-Sided|80.0|29.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved >=10 mm Schirmer test score in this reporting group, for the analysis.||||||
1714225|NCT00784719|3154441|Superiority or Other||Median|58.0|||||2-Sided|80.0|58.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved >=10 mm Schirmer test score in this reporting group, for the analysis.||||||
1714226|NCT00784719|3154441|Superiority or Other||Median|59.0|||||2-Sided|80.0|57.0||Upper limit of 80% CI was not estimable as there were insufficient number of participants, who achieved >=10 mm Schirmer test score in this reporting group, for the analysis.||||||
1714227|NCT00784654|3154448|Superiority or Other|||||||0.726|||||||Cochran-Mantel-Haenszel||||
1714228|NCT00784654|3154451|Superiority or Other||Mean Difference (Final Values)|-0.19|||<|0.001|2-Sided|95.0|-0.26|-0.11|||ANCOVA||||
1714229|NCT00784654|3154452|Superiority or Other||||||<|0.001|||||||t-test, 1 sided||||
1714230|NCT00784654|3154453|Superiority or Other||Mean Difference (Final Values)|6.5|||<|0.001|2-Sided|95.0|3.5|9.5|||ANCOVA||||
1714231|NCT00784654|3154454|Superiority or Other||||||<|0.001|||||||t-test, 1 sided||||
1714232|NCT00784654|3154458|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1714233|NCT00784654|3154461|Superiority or Other||Mean Difference (Final Values)|-12.6|||<|0.001|2-Sided|95.0|-15.4|-9.8|||ANCOVA||||
1714234|NCT00784654|3154462|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1714235|NCT00784654|3154463|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1714236|NCT00784563|3154464|Superiority or Other|||||||0.057|||||||Wilcoxon (Mann-Whitney)||||
1714237|NCT00784563|3154465|Superiority or Other|||||||0.037|||||||Regression, Linear||||
1714238|NCT00784563|3154466|Superiority or Other||||||=|0|||||||t-test, 2 sided||||
1714239|NCT00784563|3154467|Superiority or Other|||||||0.003|||||||Regression, Linear|Adjusted for change in total daily equivalent levodopa dose|||
1714240|NCT00784563|3154468|Superiority or Other|||||||0.002|||||||Regression, Linear||||
1714241|NCT00784563|3154469|Superiority or Other|||||||0.006|||||||Regression, Linear||||
1714242|NCT00784563|3154470|Superiority or Other||||||<|0.001|||||||Regression, Linear||||
1714243|NCT00784563|3154471|Superiority or Other|||||||0.07||||||unadjusted p-value=0.009|Regression, Linear||||
1714244|NCT00784563|3154472|Superiority or Other|||||||0.271|||||||Regression, Linear||||
1714245|NCT00784563|3154473|Superiority or Other|||||||0.029|||||||Regression, Linear||||
1714246|NCT00784563|3154474|Superiority or Other||||||<|0.001|||||||Regression, Linear||||
1714247|NCT00784563|3154475|Superiority or Other||||||<|0.001||||||Because all treatment arms were designed to deliver a similar average aerobic intensity, we planned to pool a priori all completers from the Continuous and Interval Training Arms for analysis.|Regression, Linear|||Sample size was estimated using 80% power to detect an effect size of 0.66 SD in VO2max (estimated improvement=10% /estimated SD of change=15%) within each arm at alpha=0.05 and an attrition rate of 25%.|
1714248|NCT00784550|3154476|Superiority or Other|||||||0.879|||||||ANCOVA|Dyspnea domain|||
1714249|NCT00784550|3154476|Superiority or Other|||||||0.394||||||Emotional function domain|ANCOVA||||
1714250|NCT00784550|3154476|Superiority or Other|||||||0.47||||||Fatigue domain|ANCOVA||||
1714251|NCT00784550|3154476|Superiority or Other|||||||0.069||||||Mastery domain|ANCOVA||||
1714252|NCT00784550|3154477|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1714253|NCT00784550|3154478|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1714254|NCT00784550|3154479|Superiority or Other|||||||0.006|||||||ANCOVA||||
1714255|NCT00784550|3154480|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1714256|NCT00784550|3154481|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1714257|NCT00784277|3154522|Superiority or Other||Difference in Least-Squares Means|1.6|Standard Error of the Mean|0.45|<|0.001||95.0|0.72|2.5||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.||
1714258|NCT00784277|3154522|Superiority or Other||Difference in Least-Squares Means|2.2|Standard Error of the Mean|0.45|<|0.001||95.0|1.34|3.12||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.||
1714259|NCT00784277|3154522|Superiority or Other||Difference in Least-Squares Means|3.1|Standard Error of the Mean|0.46|<|0.001||95.0|2.22|4.01||P-value is adjusted for multiplicity for comparison against Oxycodone using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline value as covariate.|The 95% confidence interval is unadjusted for multiplicity.||
1714260|NCT00784277|3154523|Superiority or Other||Difference in Least-Squares Means|63.4|Standard Error of the Mean|20.23||0.004||95.0|23.67|103.13||P-value is adjusted for multiplicity for comparison against placebo using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline pain intensity score as covariate.|The 95% confidence interval is unadjusted for multiplicity.||
1714261|NCT00784277|3154523|Superiority or Other||Difference in Least-Squares Means|55.1|Standard Error of the Mean|20.37||0.007||95.0|15.11|95.13||P-value is adjusted for multiplicity for comparison against placebo using Hochberg's test.|ANCOVA|The model includes treatment and pooled center as factors and baseline pain intensity score as covariate.|The 95% confidence interval is unadjusted for multiplicity.||
1714262|NCT00784225|3154538|Superiority||Cox Proportional Hazard|1.08||||0.58|2-Sided|95.0|0.83|1.41|||Regression, Cox||||
1714263|NCT00784225|3154538|Superiority||Cox Proportional Hazard|0.84||||0.19|2-Sided|95.0|0.64|1.09|||Regression, Cox||||
1714264|NCT00784225|3154539|Superiority||Cox Proportional Hazard|0.99||||0.98|2-Sided|95.0|0.35|2.82|||Regression, Cox|||Statistical analysis for number of participants with advanced AMD in SEE sites during pill-taking for vitamin E|
1714782|NCT00780026|3155177|Equivalence|If the p-value for the means is > 0.05 between the groups then they will be deemed equivalent.||||||0.384|||||||Wilcoxon (Mann-Whitney)||||
1714265|NCT00784225|3154539|Superiority||Cox Proportional Hazard|2.5||||0.12|2-Sided|95.0|0.79|7.98|||Regression, Cox|||Statistical analysis for number of participants with advanced AMD in SEE sites during pill-taking for selenium|
1714266|NCT00784225|3154540|Superiority||Cox Proportional Hazard|1.02||||0.81|2-Sided|95.0|0.84|1.25|||Regression, Cox||||
1714267|NCT00784225|3154540|Superiority||Cox Proportional Hazard|0.91||||0.37|2-Sided|95.0|0.75|1.11|||Regression, Cox||||
1714268|NCT00784225|3154541|Superiority||Cox Proportional Hazard|0.75||||0.51|2-Sided|95.0|0.31|1.77|||Regression, Cox|||Statistical analysis for number of participants with visually significant AMD in SEE sites during pill-taking for vitamin E|
1714269|NCT00784225|3154541|Superiority||Cox Proportional Hazard|0.75||||0.52|2-Sided|95.0|0.32|1.79|||Regression, Cox|||Statistical analysis for number of participants with visually significant AMD in SEE sites during pill-taking for selenium|
1714270|NCT00784134|3154549|Superiority or Other|||||||0.376|||||||t-test, 2 sided||||
1714271|NCT00784134|3154550|Superiority or Other|||||||0.224|||||||t-test, 2 sided||||
1714272|NCT00784134|3154551|Superiority or Other|||||||0.551|||||||t-test, 2 sided||||
1714273|NCT00784134|3154552|Superiority or Other|||||||0.882|||||||t-test, 2 sided||||
1714274|NCT00784134|3154553|Superiority or Other|||||||0.224|||||||t-test, 2 sided||||
1714275|NCT00784134|3154554|Superiority or Other|||||||0.255|||||||t-test, 2 sided||||
1714276|NCT00784134|3154555|Superiority or Other|||||||0.634|||||||t-test, 2 sided||||
1714277|NCT00784134|3154556|Superiority or Other|||||||0.478|||||||t-test, 2 sided||||
1714278|NCT00784134|3154557|Superiority or Other|||||||0.65|||||||t-test, 2 sided||||
1714279|NCT00784134|3154558|Superiority or Other|||||||0.312|||||||t-test, 2 sided||||
1714280|NCT00784134|3154559|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)||||
1714281|NCT00784134|3154560|Superiority or Other||Odds Ratio (OR)|0.93||||0.783|2-Sided|95.0|0.57|1.52||Adjusted generalized ordered logit model odds ratios for eGOS scores of Upper Severe Disability or worse versus Moderate Disability + Good Recovery; Alteplase versus Saline|Generalized Ordered Logit Model||||
1714282|NCT00784134|3154560|Superiority or Other||Odds Ratio (OR)|1.42||||0.336|2-Sided|95.0|0.7|2.89||Adjusted generalized ordered logit model odds ratios for eGOS scores of Moderate Disability or worse versus Good Recovery; Alteplase versus Saline|Generalized Ordered Logit Model||||
1714283|NCT00784134|3154560|Superiority or Other||Odds Ratio (OR)|1.54||||0.064|2-Sided|95.0|0.98|2.43||Adjusted Multivariable Logit Model comparing eGOS scores of Upper Severe Disability or greater versus Lower Severe Disability and worse; Alteplase versus Saline|Multivariable Logit Model||||
1714284|NCT00784134|3154560|Superiority or Other||Risk Difference (RD)|0.075||||0.087|2-Sided|95.0|-0.011|0.16||Analysis of dichotomous eGOS, comparing Upper Severe Disability scores to Lower Severe Disability scores|Chi-squared||||
1714285|NCT00784134|3154561|Superiority or Other|||||||0.312|||||||Wilcoxon (Mann-Whitney)||||
1714286|NCT00784134|3154562|Superiority or Other||Risk Difference (RD)|0.059||||0.394|2-Sided|95.0|-0.076|0.194|||Chi-squared||||
1714287|NCT00784134|3154563|Superiority or Other||Risk Difference (RD)|0.014||||0.812|2-Sided|95.0|-0.098|0.126|||Chi-squared||||
1714288|NCT00784134|3154564|Superiority or Other||Risk Difference (RD)|0.0066||||0.949|2-Sided|95.0|-0.197|0.211|||Chi-squared||||
1714289|NCT00784134|3154565|Superiority or Other||Risk Difference (RD)|0.087||||0.191|2-Sided|95.0|-0.043|0.218|||Chi-squared||||
1714290|NCT00784134|3154566|Superiority or Other||Risk Difference (RD)|0.033||||0.625|2-Sided|95.0|-0.165|0.099|||Chi-squared||||
1714291|NCT00784134|3154567|Superiority or Other||Risk Difference (RD)|0.019||||0.808|2-Sided|95.0|-0.132|0.169|||Chi-squared||||
1714292|NCT00784134|3154568|Superiority or Other||Risk Difference (RD)|0.015||||0.775|2-Sided|95.0|-0.09|0.121|||Chi-squared||||
1714293|NCT00784134|3154569|Superiority or Other||Risk Difference (RD)|0.032||||0.587|2-Sided|95.0|-0.085|0.151|||Chi-squared||||
1714294|NCT00784134|3154570|Superiority or Other||Risk Difference (RD)|0.02||||0.773|2-Sided|95.0|-0.113|0.152|||Chi-squared||||
1714295|NCT00784134|3154571|Superiority or Other||Risk Difference (RD)|0.016||||0.781|2-Sided|95.0|-0.096|0.128|||Chi-squared||||
1714296|NCT00784134|3154572|Superiority or Other||Risk Difference (RD)|0.064||||0.41|2-Sided|95.0|-0.088|0.217|||Chi-squared||||
1714297|NCT00784134|3154573|Superiority or Other||Hazard Ratio (HR)|0.6||||0.006|2-Sided|95.0|0.41|0.86|||Cox Proportional Hazards Model|Adjusted Cox Proportional Hazards Model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).|||
1714298|NCT00784134|3154574|Superiority or Other||Risk Difference (RD)|-0.144||||0.0017|2-Sided|95.0|-0.23|-0.057|||Fisher Exact||||
1714299|NCT00784134|3154575|Superiority or Other||Risk Difference (RD)|0.004||||0.811|2-Sided|95.0|-0.028|0.036|||Fisher Exact||||
1714300|NCT00784134|3154576|Superiority or Other||Risk Difference (RD)|0.004||||0.771|2-Sided|95.0|-0.022|0.03|||Fisher Exact||||
1714301|NCT00784134|3154577|Superiority or Other||Risk Difference (RD)|-0.035||||0.202|2-Sided|95.0|-0.084|0.014|||Fisher Exact||||
1714302|NCT00784134|3154578|Superiority or Other||Risk Difference (RD)|-0.055||||0.055|2-Sided|95.0|-0.111|0.008|||Fisher Exact||||
1714303|NCT00784134|3154579|Superiority or Other|||||||0.152|||||||Chi-squared||||
1714304|NCT00784134|3154580|Superiority or Other|||||||0.105|||||||Chi-squared||||
1714305|NCT00784134|3154581|Superiority or Other|||||||0.592|||||||Chi-squared||||
1714306|NCT00784134|3154582|Superiority or Other|||||||0.784|||||||Chi-squared||||
1714307|NCT00784134|3154583|Superiority or Other|||||||0.795|||||||Chi-squared||||
1714308|NCT00784134|3154584|Superiority or Other|||||||0.501|||||||Chi-squared||||
1714309|NCT00784134|3154585|Superiority or Other|||||||0.45|||||||Generalized Linear Models||||
1714310|NCT00784134|3154586|Superiority or Other|||||||0.098|||||||Kruskal-Wallis||||
1714311|NCT00784134|3154587|Superiority or Other|||||||0.771|||||||Kruskal-Wallis||||
1714312|NCT00784134|3154588|Superiority or Other||||||<|0.001|||||||AUC/ Logit Model||||
1714313|NCT00784134|3154589|Superiority or Other|||||||0.0056|||||||Log Rank||||
1714314|NCT00784134|3154590|Superiority or Other||Odds Ratio (OR)|1.01||||0.964|2-Sided|95.0|0.62|1.64|||Generalized Estimating Equation Model|Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||Logit mRS scores 0-3 at 180 days|
1714315|NCT00784134|3154590|Superiority or Other||Odds Ratio (OR)|1.26||||0.384|2-Sided|95.0|0.75|2.1|||Generalized Estimating Equation Model|Generalized estimating equation model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).||Logit mRS scores 0-3 at 30 days|
1714316|NCT00784134|3154591|Superiority or Other||Odds Ratio (OR)|1.18||||0.428|2-Sided|95.0|0.78|1.8||Random effects model with site as random effect adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).|Random Effects Model||||
1714317|NCT00784134|3154592|Superiority or Other||Odds Ratio (OR)|1.23||||0.35|2-Sided|95.0|0.8|1.9||Multivariable logit model adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical).|Multivariable Logit Model||||
1714318|NCT00784134|3154592|Superiority or Other||Risk Difference (RD)|0.026||||0.552|2-Sided|95.0|-0.059|0.111|||Chi-squared||||
1714319|NCT00784134|3154593|Superiority or Other||Odds Ratio (OR)|0.44|||<|0.001|2-Sided|95.0|0.28|0.71||The same generalized ordered logit model, adjusting for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical), compares odds ratio for mRS score greater than 5 versus mRS score equal or less than 5 (dead versus alive).|Generalized ordered Logit Model||||
1714320|NCT00784134|3154593|Superiority or Other||Odds Ratio (OR)|0.89|||<|0.484|2-Sided|95.0|0.63|1.25||Generalized ordered logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume (categorical) compares odds ratio for mRS score > K v. <= K for K = 1 - 4; Alt v. Sal.|Generalized ordered Logit Model||||
1714321|NCT00784134|3154594|Superiority or Other||Odds Ratio (OR)|1.18||||0.465|2-Sided|95.0|0.75|1.87||Multivariable logit model adjusted for age, GCS, thalamus, stability ICH volume and stability IVH volume.|Multivariable Logit Model||||
1714322|NCT00784134|3154594|Superiority or Other||Risk Difference (RD)|0.027||||0.554|2-Sided|95.0|-0.062|0.115|||Chi-squared||||
1714323|NCT00784095|3154595|Superiority or Other||Mean Difference (Final Values)|2.4|||||2-Sided|95.0|-1.9|6.7||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks.|
1714324|NCT00784095|3154595|Superiority or Other||Mean Difference (Final Values)|-0.6|||||2-Sided|95.0|-4.8|3.7||||||Intervention (Preparation and Completion) versus True Control at 8 weeks|
1714325|NCT00784095|3154596|Superiority or Other||Mean Difference (Final Values)|-1.1|||||2-Sided|95.0|-5.1|3.0||||||Intervention versus Attention Control at 8 weeks.|
1714326|NCT00784095|3154596|Superiority or Other||Mean Difference (Final Values)|-0.6|||||2-Sided|95.0|-4.5|3.4||||||Intervention (Preparation and Completion) versus True Control at 8 weeks|
1714327|NCT00784095|3154597|Superiority or Other||Mean Difference (Final Values)|-3.6|||||2-Sided|95.0|-8.2|1.0||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks|
1714328|NCT00784095|3154597|Superiority or Other||Mean Difference (Final Values)|-1.6|||||2-Sided|95.0|-6.2|2.9||||||Intervention (Preparation and Completion) versus True Control at 8 weeks|
1714329|NCT00784095|3154598|Superiority or Other||Mean Difference (Final Values)|-1.1|||||2-Sided|95.0|-5.6|3.3||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks|
1714330|NCT00784095|3154598|Superiority or Other||Mean Difference (Final Values)|1.2|||||2-Sided|95.0|-3.2|5.6||||||Intervention (Preparation and Completion) versus True Control at 8 weeks|
1714331|NCT00784095|3154599|Superiority or Other||Mean Difference (Final Values)|1.8|||||2-Sided|95.0|-1.1|4.7||||||Intervention (Preparation and Completion) versus Attention Control at 8 weeks|
1714332|NCT00784095|3154599|Superiority or Other||Mean Difference (Final Values)|2.9||||0.047|2-Sided|95.0|0.04|5.7|||Mixed Models Analysis|||Intervention (Preparation and Completion) versus True Control at 8 weeks|
1714333|NCT00783718|3154715|Superiority or Other||Risk Difference (RD)|31.4|||<|0.0001|2-Sided|95.0|16.6|46.2||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.|
1714334|NCT00783718|3154715|Superiority or Other||Risk Difference (RD)|17.6|||<|0.012|2-Sided|95.0|3.9|31.3||P-value based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.|
1714335|NCT00783718|3154716|Superiority or Other||Risk Difference (RD)|15.3||||0.0009|2-Sided|95.0|6.2|24.4||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.|
1714407|NCT00783198|3154777|Superiority or Other||Mean Difference (Final Values)|-1.8||||0.0003|2-Sided|95.0|-2.78|-0.82|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1714336|NCT00783718|3154716|Superiority or Other||Risk Difference (RD)|11.8||||0.0079|2-Sided|95.0|3.1|20.5||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.|
1714337|NCT00783718|3154717|Superiority or Other||Risk Difference (RD)|36.3|||<|0.0001|2-Sided|95.0|24.4|48.3||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.|
1714338|NCT00783718|3154717|Superiority or Other||Risk Difference (RD)|32.0|||<|0.0001|2-Sided|95.0|20.3|43.8||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.|
1714339|NCT00783718|3154718|Superiority or Other||Risk Difference (RD)|28.5|||<|0.0001|2-Sided|95.0|16.7|40.3||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.|
1714340|NCT00783718|3154718|Superiority or Other||Risk Difference (RD)|32.8|||<|0.0001|2-Sided|95.0|20.8|44.7||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.|
1714341|NCT00783718|3154719|Superiority or Other||Risk Difference (RD)|16.1||||0.0012||95.0|6.4|25.9||P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.|
1714342|NCT00783718|3154720|Superiority or Other||Risk Difference (RD)|11.5||||0.0009|2-Sided|95.0|4.7|18.3||P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel|||To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.|
1714343|NCT00783718|3154721|Superiority or Other||Risk Difference (RD)|29.1|||<|0.0001|2-Sided|95.0|17.9|40.4||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was > 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.|
1714344|NCT00783718|3154721|Superiority or Other||Risk Difference (RD)|26.1|||<|0.0001|2-Sided|95.0|14.9|37.2||P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.|Cochran-Mantel-Haenszel|||The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was > 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.|
1714552|NCT00782418|3154899|Superiority or Other||Least Squares Mean|2.32|||<|0.001||90.0|1.57|3.06|||ANOVA|1-sided, alpha=0.05|||
1714345|NCT00783718|3154722|Superiority or Other||Risk Difference (RD)|21.7|||<|0.0001|2-Sided|95.0|11.6|31.7|||Cochran-Mantel-Haenszel|||The primary comparison of the Induction Phase was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level, with stratification according to the stratification factors (concomitant use of oral corticosteroids and previous exposure to tumor necrosis factor alpha (TNFα) antagonists or concomitant immunomodulator [6-mercaptopurine or azathioprine] use).|
1714346|NCT00783705|3154723|Superiority or Other|||||||0.52|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker SFTPD level between arms.|
1714347|NCT00783705|3154724|Superiority or Other|||||||0.46|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC18 level between arms.|
1714348|NCT00783705|3154725|Superiority or Other|||||||0.91|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker Nitrotyrosine level between arms.|
1714349|NCT00783705|3154726|Superiority or Other|||||||0.55|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker MPO level between arms.|
1714350|NCT00783705|3154727|Superiority or Other|||||||0.74|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CCL-2 level between arms.|
1714351|NCT00783705|3154728|Superiority or Other|||||||0.22|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker IL-6 level between arms.|
1714352|NCT00783705|3154729|Superiority or Other|||||||0.8|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CRP level between arms.|
1714353|NCT00783705|3154730|Superiority or Other|||||||0.35|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC-16 level between arms.|
1714354|NCT00783705|3154731|Superiority or Other|||||||0.06|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker Total Glutathione level between arms.|
1714355|NCT00783705|3154732|Superiority or Other|||||||0.22|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker SFTPD level between arms.|
1714356|NCT00783705|3154733|Superiority or Other|||||||0.63|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC18 level between arms.|
1714357|NCT00783705|3154734|Superiority or Other|||||||0.06|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker MPO level between arms.|
1714358|NCT00783705|3154735|Superiority or Other|||||||0.58|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CCL-2 level between arms.|
1714359|NCT00783705|3154736|Superiority or Other|||||||0.03|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker IL-6 level between arms.|
1714360|NCT00783705|3154737|Superiority or Other|||||||0.1|||||||Wilcoxon Rank-Sum|||Comparison of the median difference in biomarker CC-16 level between arms.|
1714361|NCT00783705|3154741|Superiority or Other||Odds Ratio (OR)|1.4||||0.39|2-Sided|95.0|0.7|3.0|||Generalized estimating equation model|||Generalized estimating equation model on lesions (progressive disease vs. complete response/stable disease) was used to account for intra-patient correlation in the lesion-specific analysis.|
1714362|NCT00783692|3154743|Superiority or Other||Risk Difference (RD)|2.0||||0.6413|2-Sided|95.0|-6.3|10.2||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.|
1714363|NCT00783692|3154743|Superiority or Other||Risk Difference (RD)|7.2||||0.1036|2-Sided|95.0|-1.5|16.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.|
1714364|NCT00783692|3154744|Superiority or Other||Risk Difference (RD)|12.9||||0.045|2-Sided|95.0|0.3|25.5||P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.|
1714365|NCT00783692|3154744|Superiority or Other||Risk Difference (RD)|15.9||||0.0154|2-Sided|95.0|3.0|28.7||P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.|
1714783|NCT00780026|3155178|Superiority or Other|||||||0.999|||||||Fisher Exact||||
1714366|NCT00783692|3154745|Superiority or Other||Risk Difference (RD)|15.3||||0.0053|2-Sided|95.0|4.6|26.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.|
1714367|NCT00783692|3154745|Superiority or Other||Risk Difference (RD)|13.4||||0.0132|2-Sided|95.0|2.8|24.0||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.|
1714368|NCT00783692|3154746|Superiority or Other|||||||0.9288||||||Wilcoxon Rank Sum test on the CRP change from baseline values (two-sided).|Wilcoxon (Mann-Whitney)|||If at least 1 of the primary endpoints was significant, the sequential Hochberg procedure was to be used to test the secondary endpoint for significance at the 0.05% level.|
1714369|NCT00783692|3154747|Superiority or Other||Risk Difference (RD)|14.7||||0.0042|2-Sided|95.0|4.6|24.7||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both p-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the p-values for the 2 dose comparisons was > 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.|
1714370|NCT00783692|3154747|Superiority or Other||Risk Difference (RD)|17.4||||0.0007|2-Sided|95.0|7.3|27.5||CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both p-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the p-values for the 2 dose comparisons was > 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.|
1714371|NCT00783692|3154748|Superiority or Other||Risk Difference (RD)|5.7||||0.2322|2-Sided|95.0|-3.6|15.0||P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints was > 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither primary was declared significant, no further testing was to be conducted.|
1714372|NCT00783692|3154749|Superiority or Other||Risk Difference (RD)|7.8||||0.0206|2-Sided|95.0|1.2|14.3||P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).|Cochran-Mantel-Haenszel||Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo|The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints was > 0.05, the other p-value was to be tested at the 0.025 level and declared significant only if the p-value was ≤ 0.025. If neither primary was declared significant, no further testing was to be conducted.|
1714373|NCT00783432|3154752|Superiority or Other|||||||0.725||||||This P-Value is for Month 12/ET|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.|
1714374|NCT00783432|3154752|Superiority or Other|||||||0.319||||||This P-Value is for Month 9|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.|
1714375|NCT00783432|3154752|Superiority or Other|||||||0.168||||||This P-Value is for Month 6|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.|
1714553|NCT00782418|3154899|Superiority or Other||Least Squares Mean|0.95|||<|0.001||90.0|0.66|1.24|||ANOVA|1-sided, alpha=0.05|||
1714376|NCT00783432|3154752|Superiority or Other|||||||0.991||||||This P-Value is for Month 3|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.|
1714377|NCT00783432|3154752|Superiority or Other|||||||0.327||||||This P-Value if for Month 1|ANCOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.|
1714378|NCT00783432|3154752|Superiority or Other|||||||0.368||||||This is the Baseline P-Value|ANOVA|||Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.|
1714379|NCT00783263|3154766|Superiority or Other||Mean Difference (Final Values)|-1.08||||0.861|2-Sided|95.0|-13.13|10.97|||Longitudinal Data Analysis|||hs-C-Reactive Protein|
1714380|NCT00783263|3154766|Superiority or Other||Mean Difference (Final Values)|-7.54|||<|0.001|2-Sided|95.0|-11.25|-3.83|||Longitudinal Data Analysis|||Apolipoprotein B/Apo A-I|
1714381|NCT00783263|3154766|Superiority or Other||Mean Difference (Final Values)|-1.82|||<|0.102|2-Sided|95.0|-3.99|0.36|||Longitudinal Data Analysis|||Apolipoprotein A-I (Apo A-I)|
1714382|NCT00783263|3154766|Superiority or Other||Mean Difference (Final Values)|-9.41|||<|0.001|2-Sided|95.0|-12.74|-6.08|||Longitudinal Data Analysis|||Apolipoprotein B (Apo B)|
1714383|NCT00783263|3154766|Superiority or Other||Mean Difference (Final Values)|-9.52|||<|0.001|2-Sided|95.0|-15.3|-3.75|||Longitudinal Data Analysis|||Non-HDL Cholestrol/HDL Cholesterol|
1714384|NCT00783263|3154766|Superiority or Other||Mean Difference (Final Values)|-6.45|||<|0.002|2-Sided|95.0|-10.53|-2.36|||Longitudinal Data Analysis|||Total Cholesterol/HDL Cholesterol|
1714385|NCT00783263|3154766|Superiority or Other||Mean Difference (Final Values)|-13.25|||<|0.001|2-Sided|95.0|-18.36|-8.13|||Longitudinal Data Analysis|||LDL Cholesterol/HDL Cholesterol|
1714386|NCT00783263|3154766|Superiority or Other||Mean Difference (Final Values)|-11.98|||<|0.001|2-Sided|95.0|-16.1|-7.86|||Longitudinal Data Analysis|||Non High-Density Liproprotein Cholesterol|
1714387|NCT00783263|3154766|Superiority or Other||Mean Difference (Final Values)|-2.15|||<|0.111|2-Sided|95.0|-4.79|0.49|||Longitudinal Data Analysis|||High-Density Lipoprotein Cholesterol|
1714388|NCT00783263|3154766|Superiority or Other||Mean Difference (Final Values)|-3.1|||<|0.306|2-Sided|95.0|-9.04|2.84|||Longitudinal Data Analysis|||Triglycerides (mg/dL)|
1714389|NCT00783263|3154766|Superiority or Other||Mean Difference (Final Values)|-8.65|||<|0.001|2-Sided|95.0|-11.59|-5.71|||Longitudinal Data Analysis|||Total Cholesterol (mg/dL)|
1714390|NCT00783263|3154767|Superiority or Other||Odds Ratio (OR)|11.4|||<|0.001|2-Sided|95.0|5.2|24.8|||Logistic Regression|||Stratum II|
1714391|NCT00783263|3154767|Superiority or Other||Odds Ratio (OR)|5.1|||<|0.001|2-Sided|95.0|2.2|11.8|||Logistic Regression|||Stratum I|
1714392|NCT00783263|3154768|Superiority or Other||Odds Ratio (OR)|8.0|||<|0.001|2-Sided|95.0|4.6|14.0|||Logistic Regression||||
1714393|NCT00783263|3154769|Superiority or Other||Odds Ratio (OR)|6.5|||<|0.001|2-Sided|95.0|3.4|12.3|||Logistic Regression|Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: <100, 100-<130, >=130 mg/dL).|||
1714394|NCT00783263|3154769|Superiority or Other||Odds Ratio (OR)|3.1|||<|0.001|2-Sided|95.0|1.7|5.8|||Logistic Regression|Logistic Regression included terms for treatment and baseline LDL-C category (3 levels: <100, 100-<130, >=130 mg/dL).|||
1714395|NCT00783263|3154770|Superiority or Other||Odds Ratio (OR)|4.5|||<|0.001|2-Sided|95.0|2.9|6.9|||Logistic Regression|Logistic Regression included terms for treatment, stratum and baseline LDL-C category (3 levels: <100, 100-<130, ≥130 mg/dL).|||
1714396|NCT00783263|3154771|Superiority or Other||Mean Difference (Final Values)|-17.46|||<|0.001|2-Sided|95.0|-23.92|-10.99|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.|||
1714397|NCT00783263|3154771|Superiority or Other||Mean Difference (Final Values)|-12.31|||<|0.001|2-Sided|95.0|-18.95|-5.67|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time and the interaction of time by treatment.|||
1714398|NCT00783263|3154772|Superiority or Other||Mean Difference (Final Values)|-15.25|||<|0.001|2-Sided|95.0|-19.89|-10.6|||Longitudinal Data Analysis (LDA)|Longitudinal Data Analysis was based on a constrained LDA model with terms for treatment, time, stratum and the interaction of time by treatment.|||
1714399|NCT00783224|3154773|Superiority or Other|||||||0.0001|||||||ANCOVA||||
1714400|NCT00783224|3154773|Superiority or Other|||||||0.0001|||||||ANCOVA||||
1714401|NCT00783198|3154774|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.0001|2-Sided|95.0|-1.95|-0.64|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1714402|NCT00783198|3154774|Superiority or Other||Mean Difference (Final Values)|-0.98||||0.0039|2-Sided|95.0|-1.65|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1714403|NCT00783198|3154775|Superiority or Other||Mean Difference (Final Values)|-0.82||||0.0125|2-Sided|95.0|-1.46|-0.18|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1714404|NCT00783198|3154775|Superiority or Other||Mean Difference (Final Values)|-0.46||||0.1686|2-Sided|95.0|-1.11|0.19|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1714405|NCT00783198|3154776|Superiority or Other||Mean Difference (Final Values)|-0.94||||0.0144|2-Sided|95.0|-1.7|-0.19|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1714406|NCT00783198|3154776|Superiority or Other||Mean Difference (Final Values)|-0.78||||0.0472|2-Sided|95.0|-1.54|-0.01|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1714408|NCT00783198|3154777|Superiority or Other||Mean Difference (Final Values)|-1.09||||0.032|2-Sided|95.0|-2.08|-0.09|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1714409|NCT00783198|3154778|Superiority or Other||Mean Difference (Final Values)|-2.24||||0.0002|2-Sided|95.0|-3.41|-1.07|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1714410|NCT00783198|3154778|Superiority or Other||Mean Difference (Final Values)|-1.76||||0.0039|2-Sided|95.0|-2.95|-0.57|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1714411|NCT00783094|3154790|Superiority or Other|||||||0.212|||||||Wilcoxin rank-sum||||
1714412|NCT00783094|3154790|Superiority or Other|||||||0.06|||||||Wilcoxin rank-sum||||
1714413|NCT00783094|3154791|Superiority or Other|||||||0.426|||||||Wilcoxin rank-sum test||||
1714414|NCT00783094|3154791|Superiority or Other|||||||0.428|||||||Wilcoxin rank-sum test||||
1714415|NCT00783094|3154792|Superiority or Other|||||||0.149|||||||Wilcoxin rank-sum test||||
1714416|NCT00783094|3154792|Superiority or Other|||||||0.606|||||||Wilcoxin rank-sum test||||
1714417|NCT00783094|3154793|Superiority or Other|||||||0.173||||||P-Value for diastolic blood pressure.|Wilcoxin rank-sum test||||
1714418|NCT00783094|3154793|Superiority or Other|||||||0.705||||||P-Value for diastolic blood pressure.|Wilcoxin rank-sum test||||
1714419|NCT00783094|3154793|Superiority or Other|||||||0.127||||||P-Value for systolic blood pressure.|Wilcoxin rank sum test||||
1714420|NCT00783094|3154793|Superiority or Other|||||||0.342||||||P-Value for systolic blood pressure.|Wilcoxin rank-sum test||||
1714421|NCT00783094|3154796|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.4||0.094|2-Sided|95.0|-1.6|0.1|||ANCOVA|With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.||
1714422|NCT00783094|3154796|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.4||0.147|2-Sided|95.0|-1.5|0.2|||ANCOVA|With effects for treatment, BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.||
1714423|NCT00783094|3154797|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.2||0.8|2-Sided|95.0|-0.4|0.3|||ANCOVA|With effects for treatment, BPH severity(moderate/severe), prior alpha blocker use (yes/no), and baseline value.|||
1714424|NCT00783094|3154797|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.2||0.904|2-Sided|95.0|-0.4|0.3|||ANCOVA|with effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.||
1714425|NCT00783094|3154798|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.022|2-Sided|95.0|-0.6|0.0|||ANCOVA|With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.||
1714426|NCT00783094|3154798|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.249|2-Sided|95.0|-0.4|0.1|||ANCOVA|With effects for treatment,BPH severity (moderate/severe), prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.||
1714427|NCT00783094|3154799|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.4||0.033|2-Sided|95.0|-1.7|-0.1|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.||
1714428|NCT00783094|3154799|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.4||0.228|2-Sided|95.0|-1.3|0.3|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo||
1714429|NCT00783094|3154800|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.2||0.487|2-Sided|95.0|-0.6|0.3|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.||
1714430|NCT00783094|3154800|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.2||0.356|2-Sided|95.0|-0.7|0.2|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo.||
1714431|NCT00783094|3154801|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.6||0.062|2-Sided|95.0|-2.2|0.1|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no) and baseline value.|Least Squares Mean Difference = Tadalafil 5 mg - Placebo.||
1714432|NCT00783094|3154801|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.6||0.201|2-Sided|95.0|-1.8|0.4|||ANCOVA|With effects for treatment, prior alpha blocker use (yes/no), and baseline value.|Least Squares Mean Difference = Tadalafil 2.5 mg - Placebo||
1714433|NCT00782509|3154837|Superiority or Other||Incidence rate ratio|1.3373|Standard Error of the Mean|0.2901||0.1807|2-Sided|95.0|0.8735|2.0474|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo||
1714434|NCT00782509|3154837|Superiority or Other||Incidence rate ratio|1.2846|Standard Error of the Mean|0.2803||0.2514|2-Sided|95.0|0.837|1.9717|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo||
1714435|NCT00782509|3154838|Superiority or Other||Incidence rate ratio|1.1273|Standard Error of the Mean|0.5028||0.7883|2-Sided|95.0|0.4696|2.7064|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo||
1714436|NCT00782509|3154838|Superiority or Other||Incidence rate ratio|1.0314|Standard Error of the Mean|0.4664||0.9455|2-Sided|95.0|0.4244|2.5063|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo||
1714437|NCT00782509|3154839|Superiority or Other||Incidence rate ratio|1.2822|Standard Error of the Mean|0.2403||0.1853|2-Sided|95.0|0.8874|1.8527|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo||
1714438|NCT00782509|3154839|Superiority or Other||Incidence rate ratio|1.188|Standard Error of the Mean|0.2251||0.3637|2-Sided|95.0|0.8188|1.7234|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo||
1714439|NCT00782509|3154840|Superiority or Other||Hazard Ratio (HR)|1.344|Standard Error of the Mean|0.273||0.1437|2-Sided|95.0|0.902|2.002|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum||
1714440|NCT00782509|3154840|Superiority or Other||Hazard Ratio (HR)|1.09|Standard Error of the Mean|0.233||0.669|2-Sided|95.0|0.717|1.657|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum||
1714441|NCT00782509|3154841|Superiority or Other||Hazard Ratio (HR)|0.958|Standard Error of the Mean|0.408||0.9304|2-Sided|95.0|0.415|2.209|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum||
1714442|NCT00782509|3154841|Superiority or Other||Hazard Ratio (HR)|1.05|Standard Error of the Mean|0.438||0.9035|2-Sided|95.0|0.463|2.38|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum||
1714443|NCT00782509|3154842|Superiority or Other||Hazard Ratio (HR)|1.241|Standard Error of the Mean|0.222||0.2344|2-Sided|95.0|0.873|1.763|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum||
1714444|NCT00782509|3154842|Superiority or Other||Hazard Ratio (HR)|0.993|Standard Error of the Mean|0.187||0.9853|2-Sided|95.0|0.687|1.436|||Log Rank|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum||
1714445|NCT00782509|3154843|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0089||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo||
1714446|NCT00782509|3154843|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.1313||95.0|-0.4|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum,visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo||
1714447|NCT00782509|3154844|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0015||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo||
1714448|NCT00782509|3154844|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.018||95.0|-0.5|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo||
1714449|NCT00782509|3154845|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0169||95.0|-0.5|0.0|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo||
1714450|NCT00782509|3154845|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0028||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo||
1714451|NCT00782509|3154846|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.1||0.0008||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo||
1714452|NCT00782509|3154846|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0122||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo||
1714453|NCT00782509|3154847|Superiority or Other||Mean Difference (Final Values)|-1.278|Standard Error of the Mean|0.249|<|0.0001|2-Sided|95.0|-1.767|-0.789|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714454|NCT00782509|3154847|Superiority or Other||Mean Difference (Final Values)|-0.837|Standard Error of the Mean|0.252|<|0.001|2-Sided|95.0|-1.333|-0.342|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714455|NCT00782509|3154848|Superiority or Other||Mean Difference (Final Values)|-0.76|Standard Error of the Mean|0.155|<|0.0001||95.0|-1.065|-0.456|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714456|NCT00782509|3154848|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.157|<|0.0077|2-Sided|95.0|-0.729|-0.111|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714457|NCT00782509|3154849|Superiority or Other||Mean Difference (Final Values)|-0.513|Standard Error of the Mean|0.125|<|0.0001|2-Sided|95.0|-0.76|-0.267|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714458|NCT00782509|3154849|Superiority or Other||Mean Difference (Final Values)|-0.416|Standard Error of the Mean|0.127|<|0.0011|2-Sided|95.0|-0.665|-0.167|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714459|NCT00782509|3154850|Superiority or Other||Mean Difference (Final Values)|20.653|Standard Error of the Mean|5.132|<|0.0001|2-Sided|95.0|10.574|30.731|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714460|NCT00782509|3154850|Superiority or Other||Mean Difference (Final Values)|12.456|Standard Error of the Mean|5.201|<|0.0169|2-Sided|95.0|2.242|22.67|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714461|NCT00782509|3154851|Superiority or Other||Mean Difference (Final Values)|20.934|Standard Error of the Mean|4.894|<|0.0001|2-Sided|95.0|11.323|30.545|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714462|NCT00782509|3154851|Superiority or Other||Mean Difference (Final Values)|13.36|Standard Error of the Mean|4.959|<|0.0072|2-Sided|95.0|3.622|23.099|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714463|NCT00782509|3154852|Superiority or Other||Mean Difference (Final Values)|0.156|Standard Error of the Mean|0.048||0.0013||95.0|0.061|0.25|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo||
1714464|NCT00782509|3154852|Superiority or Other||Mean Difference (Final Values)|0.142|Standard Error of the Mean|0.047||0.0028||95.0|0.049|0.235|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo||
1714465|NCT00782509|3154853|Superiority or Other||Mean Difference (Final Values)|0.211|Standard Error of the Mean|0.037|<|0.0001||95.0|0.138|0.285|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714466|NCT00782509|3154853|Superiority or Other||Mean Difference (Final Values)|0.207|Standard Error of the Mean|0.037|<|0.0001||95.0|0.133|0.28|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714467|NCT00782509|3154854|Superiority or Other||Mean Difference (Final Values)|0.206|Standard Error of the Mean|0.037|<|0.0001||95.0|0.133|0.279|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714468|NCT00782509|3154854|Superiority or Other||Mean Difference (Final Values)|0.226|Standard Error of the Mean|0.037|<|0.0001||95.0|0.153|0.299|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714469|NCT00782509|3154855|Superiority or Other||Mean Difference (Final Values)|0.209|Standard Error of the Mean|0.037|<|0.0001||95.0|0.137|0.281|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714470|NCT00782509|3154855|Superiority or Other||Mean Difference (Final Values)|0.226|Standard Error of the Mean|0.037|<|0.0001||95.0|0.154|0.298|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714471|NCT00782509|3154856|Superiority or Other||Mean Difference (Final Values)|0.251|Standard Error of the Mean|0.037|<|0.0001||95.0|0.179|0.323|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714472|NCT00782509|3154856|Superiority or Other||Mean Difference (Final Values)|0.268|Standard Error of the Mean|0.037|<|0.0001||95.0|0.196|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714473|NCT00782509|3154857|Superiority or Other||Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.036|<|0.0001||95.0|0.139|0.281|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714474|NCT00782509|3154857|Superiority or Other||Mean Difference (Final Values)|0.225|Standard Error of the Mean|0.036|<|0.0001||95.0|0.153|0.296|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714475|NCT00782509|3154858|Superiority or Other||Mean Difference (Final Values)|0.333|Standard Error of the Mean|0.036|<|0.0001||95.0|0.263|0.403|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714476|NCT00782509|3154858|Superiority or Other||Mean Difference (Final Values)|0.332|Standard Error of the Mean|0.036|<|0.0001||95.0|0.261|0.403|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714477|NCT00782509|3154859|Superiority or Other||Mean Difference (Final Values)|0.062|Standard Error of the Mean|0.038||0.0994||95.0|-0.012|0.136|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714478|NCT00782509|3154859|Superiority or Other||Mean Difference (Final Values)|0.046|Standard Error of the Mean|0.038||0.2249||95.0|-0.028|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714479|NCT00782509|3154860|Superiority or Other||Mean Difference (Final Values)|0.069|Standard Error of the Mean|0.038||0.0662||95.0|-0.005|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714480|NCT00782509|3154860|Superiority or Other||Mean Difference (Final Values)|0.042|Standard Error of the Mean|0.038||0.268||95.0|-0.032|0.115|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714481|NCT00782509|3154861|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.038||0.9426||95.0|-0.076|0.071|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714482|NCT00782509|3154861|Superiority or Other||Mean Difference (Final Values)|0.038|Standard Error of the Mean|0.037||0.311||95.0|-0.036|0.111|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714483|NCT00782509|3154862|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.037||0.0596||95.0|-0.003|0.144|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714484|NCT00782509|3154862|Superiority or Other||Mean Difference (Final Values)|0.045|Standard Error of the Mean|0.037||0.2312||95.0|-0.029|0.118|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714485|NCT00782509|3154863|Superiority or Other||Mean Difference (Final Values)|0.033|Standard Error of the Mean|0.037||0.37||95.0|-0.039|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714486|NCT00782509|3154863|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.037||0.1808||95.0|-0.023|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714487|NCT00782509|3154864|Superiority or Other||Mean Difference (Final Values)|0.048|Standard Error of the Mean|0.037||0.1917||95.0|-0.024|0.12|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714488|NCT00782509|3154864|Superiority or Other||Mean Difference (Final Values)|0.032|Standard Error of the Mean|0.037||0.3821||95.0|-0.04|0.105|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714489|NCT00782509|3154865|Superiority or Other||Mean Difference (Final Values)|0.118|Standard Error of the Mean|0.037||0.0013||95.0|0.046|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714490|NCT00782509|3154865|Superiority or Other||Mean Difference (Final Values)|0.094|Standard Error of the Mean|0.037||0.0106||95.0|0.022|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714491|NCT00782509|3154866|Superiority or Other||Mean Difference (Final Values)|0.087|Standard Error of the Mean|0.036||0.0172||95.0|0.015|0.158|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714492|NCT00782509|3154866|Superiority or Other||Mean Difference (Final Values)|0.059|Standard Error of the Mean|0.037||0.104||95.0|-0.012|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714493|NCT00782509|3154867|Superiority or Other||Mean Difference (Final Values)|0.218|Standard Error of the Mean|0.036|<|0.0001||95.0|0.148|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714494|NCT00782509|3154867|Superiority or Other||Mean Difference (Final Values)|0.217|Standard Error of the Mean|0.036|<|0.0001||95.0|0.147|0.288|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714495|NCT00782509|3154868|Superiority or Other||Mean Difference (Final Values)|0.219|Standard Error of the Mean|0.035|<|0.0001||95.0|0.15|0.289|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714496|NCT00782509|3154868|Superiority or Other||Mean Difference (Final Values)|0.241|Standard Error of the Mean|0.036|<|0.0001||95.0|0.171|0.311|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714497|NCT00782509|3154869|Superiority or Other||Mean Difference (Final Values)|0.245|Standard Error of the Mean|0.035|<|0.0001||95.0|0.176|0.314|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714498|NCT00782509|3154869|Superiority or Other||Mean Difference (Final Values)|0.239|Standard Error of the Mean|0.035|<|0.0001||95.0|0.17|0.308|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714499|NCT00782509|3154870|Superiority or Other||Mean Difference (Final Values)|0.246|Standard Error of the Mean|0.035|<|0.0001||95.0|0.178|0.315|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714500|NCT00782509|3154870|Superiority or Other||Mean Difference (Final Values)|0.263|Standard Error of the Mean|0.035|<|0.0001||95.0|0.195|0.332|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714501|NCT00782509|3154871|Superiority or Other||Mean Difference (Final Values)|0.226|Standard Error of the Mean|0.035|<|0.0001||95.0|0.159|0.294|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714502|NCT00782509|3154871|Superiority or Other||Mean Difference (Final Values)|0.242|Standard Error of the Mean|0.035|<|0.0001||95.0|0.174|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714503|NCT00782509|3154872|Superiority or Other||Mean Difference (Final Values)|0.333|Standard Error of the Mean|0.034|<|0.0001||95.0|0.265|0.4|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714504|NCT00782509|3154872|Superiority or Other||Mean Difference (Final Values)|0.331|Standard Error of the Mean|0.035|<|0.0001||95.0|0.263|0.399|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714505|NCT00782509|3154873|Superiority or Other||Mean Difference (Final Values)|0.157|Standard Error of the Mean|0.019|<|0.0001||95.0|0.12|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714554|NCT00782418|3154899|Superiority or Other||Least Squares Mean|1.6|||<|0.001||90.0|1.29|1.92||1-sided, alpha=0.05|ANOVA||||
1714506|NCT00782509|3154873|Superiority or Other||Mean Difference (Final Values)|0.155|Standard Error of the Mean|0.019|<|0.0001||95.0|0.118|0.192|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714507|NCT00782509|3154874|Superiority or Other||Mean Difference (Final Values)|0.135|Standard Error of the Mean|0.019|<|0.0001||95.0|0.098|0.171|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714508|NCT00782509|3154874|Superiority or Other||Mean Difference (Final Values)|0.164|Standard Error of the Mean|0.019|<|0.0001||95.0|0.128|0.201|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714509|NCT00782509|3154875|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.018|<|0.0001||95.0|0.094|0.166|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714510|NCT00782509|3154875|Superiority or Other||Mean Difference (Final Values)|0.144|Standard Error of the Mean|0.018|<|0.0001||95.0|0.108|0.18|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714511|NCT00782509|3154876|Superiority or Other||Mean Difference (Final Values)|0.166|Standard Error of the Mean|0.018|<|0.0001||95.0|0.13|0.202|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714512|NCT00782509|3154876|Superiority or Other||Mean Difference (Final Values)|0.172|Standard Error of the Mean|0.018|<|0.0001||95.0|0.136|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714513|NCT00782509|3154877|Superiority or Other||Mean Difference (Final Values)|0.147|Standard Error of the Mean|0.018|<|0.0001||95.0|0.111|0.182|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714514|NCT00782509|3154877|Superiority or Other||Mean Difference (Final Values)|0.155|Standard Error of the Mean|0.018|<|0.0001||95.0|0.119|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714515|NCT00782509|3154878|Superiority or Other||Mean Difference (Final Values)|0.177|Standard Error of the Mean|0.018|<|0.0001||95.0|0.142|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714516|NCT00782509|3154878|Superiority or Other||Mean Difference (Final Values)|0.168|Standard Error of the Mean|0.018|<|0.0001||95.0|0.132|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714517|NCT00782509|3154879|Superiority or Other||Mean Difference (Final Values)|0.071|Standard Error of the Mean|0.019||0.0002||95.0|0.033|0.108|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714518|NCT00782509|3154879|Superiority or Other||Mean Difference (Final Values)|0.068|Standard Error of the Mean|0.019||0.0004||95.0|0.031|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714519|NCT00782509|3154880|Superiority or Other||Mean Difference (Final Values)|0.072|Standard Error of the Mean|0.019||0.0002||95.0|0.034|0.109|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714520|NCT00782509|3154880|Superiority or Other||Mean Difference (Final Values)|0.062|Standard Error of the Mean|0.019||0.0012||95.0|0.025|0.099|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714521|NCT00782509|3154881|Superiority or Other||Mean Difference (Final Values)|0.027|Standard Error of the Mean|0.019||0.1614||95.0|-0.011|0.064|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714522|NCT00782509|3154881|Superiority or Other||Mean Difference (Final Values)|0.058|Standard Error of the Mean|0.019||0.0024||95.0|0.02|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714523|NCT00782509|3154882|Superiority or Other||Mean Difference (Final Values)|0.058|Standard Error of the Mean|0.019||0.002||95.0|0.021|0.095|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714524|NCT00782509|3154882|Superiority or Other||Mean Difference (Final Values)|0.069|Standard Error of the Mean|0.019||0.0003||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714525|NCT00782509|3154883|Superiority or Other||Mean Difference (Final Values)|0.044|Standard Error of the Mean|0.019||0.0186||95.0|0.007|0.081|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714526|NCT00782509|3154883|Superiority or Other||Mean Difference (Final Values)|0.069|Standard Error of the Mean|0.019||0.0002||95.0|0.032|0.106|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714784|NCT00780026|3155179|Superiority or Other|||||||0.505||||||P value for viral infection|Chi-squared||||
1714924|NCT00775684|3155637|Superiority||||||>|0.1|||||||t-test, 1 sided||||
1714527|NCT00782509|3154884|Superiority or Other||Mean Difference (Final Values)|0.085|Standard Error of the Mean|0.018|<|0.0001||95.0|0.049|0.121|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714528|NCT00782509|3154884|Superiority or Other||Mean Difference (Final Values)|0.073|Standard Error of the Mean|0.018|<|0.0001||95.0|0.037|0.11|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714529|NCT00782509|3154885|Superiority or Other||Mean Difference (Final Values)|0.065|Standard Error of the Mean|0.018||0.0005||95.0|0.028|0.101|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714530|NCT00782509|3154885|Superiority or Other||Mean Difference (Final Values)|0.053|Standard Error of the Mean|0.018||0.0043||95.0|0.017|0.089|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714531|NCT00782509|3154886|Superiority or Other||Mean Difference (Final Values)|0.158|Standard Error of the Mean|0.013|<|0.0001||95.0|0.123|0.193|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714532|NCT00782509|3154886|Superiority or Other||Mean Difference (Final Values)|0.161|Standard Error of the Mean|0.018|<|0.0001||95.0|0.127|0.196|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714533|NCT00782509|3154887|Superiority or Other||Mean Difference (Final Values)|0.136|Standard Error of the Mean|0.018|<|0.0001||95.0|0.102|0.171|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714534|NCT00782509|3154887|Superiority or Other||Mean Difference (Final Values)|0.165|Standard Error of the Mean|0.018|<|0.0001||95.0|0.131|0.2|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714535|NCT00782509|3154888|Superiority or Other||Mean Difference (Final Values)|0.161|Standard Error of the Mean|0.017|<|0.0001||95.0|0.127|0.195|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714536|NCT00782509|3154888|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.017|<|0.0001||95.0|0.135|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714537|NCT00782509|3154889|Superiority or Other||Mean Difference (Final Values)|0.152|Standard Error of the Mean|0.017|<|0.0001||95.0|0.119|0.186|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714538|NCT00782509|3154889|Superiority or Other||Mean Difference (Final Values)|0.163|Standard Error of the Mean|0.017|<|0.0001||95.0|0.13|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714539|NCT00782509|3154890|Superiority or Other||Mean Difference (Final Values)|0.171|Standard Error of the Mean|0.017|<|0.0001||95.0|0.138|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714540|NCT00782509|3154890|Superiority or Other||Mean Difference (Final Values)|0.164|Standard Error of the Mean|0.017|<|0.0001||95.0|0.131|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714541|NCT00782509|3154891|Superiority or Other||Mean Difference (Final Values)|0.089|Standard Error of the Mean|0.027||0.0011||95.0|0.036|0.143|||Mixed Models Analysis|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo||
1714542|NCT00782509|3154891|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.027|<|0.0001||95.0|0.057|0.162|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo||
1714543|NCT00782509|3154892|Superiority or Other||Mean Difference (Final Values)|0.048|Standard Error of the Mean|0.019||0.0095||95.0|0.012|0.085|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714544|NCT00782509|3154892|Superiority or Other||Mean Difference (Final Values)|0.047|Standard Error of the Mean|0.019||0.0116||95.0|0.011|0.084|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714545|NCT00782509|3154893|Superiority or Other||Mean Difference (Final Values)|0.143|Standard Error of the Mean|0.017|<|0.0001||95.0|0.11|0.177|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714546|NCT00782509|3154893|Superiority or Other||Mean Difference (Final Values)|0.151|Standard Error of the Mean|0.017|<|0.0001||95.0|0.116|0.185|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714547|NCT00782418|3154897|Superiority or Other||Least Squares Mean|246.6|||<|0.001||90.0|160.9|323.3|||ANOVA|1-side, alpha = 0.05|||
1714548|NCT00782418|3154897|Superiority or Other||Least Squares Mean|545.0|||<|0.001||90.0|451.4|638.7|||ANOVA|1-side, alpha = 0.05|||
1714549|NCT00782418|3154898|Superiority or Other||Least Squares Mean|16.4|||<|0.001||90.0|12.6|20.1|||ANOVA|1-side, alpha = 0.05|||
1714550|NCT00782418|3154898|Superiority or Other||Least Squares Mean|23.1|||<|0.001||90.0|19.2|27.0|||ANOVA|1-side, alpha = 0.05|||
1714551|NCT00782418|3154899|Superiority or Other||Least Squares Mean|1.38|||<|0.001||90.0|0.64|2.12|||ANOVA|1-sided, alpha = 0.05|||
1714555|NCT00782340|3154913|Superiority or Other|||||||0.327||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the this endpoint was not positive, no additional statistical analyses will be performed on secondary endpoints.|Fisher Exact||||
1714556|NCT00782340|3154914|Superiority or Other||||||<|0.001||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.|||
1714557|NCT00782340|3154915|Superiority or Other|||||||0.009||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.|||
1714558|NCT00782340|3154916|Superiority or Other|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at baseline.|||
1714559|NCT00782340|3154917|Superiority or Other|||||||0.01||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model including a factor for randomized treatment along with the OHSA composite value at randomization as a covariate.|||
1714560|NCT00782340|3154918|Superiority or Other|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHDAS composite score as a co-variate.|||
1714561|NCT00782340|3154919|Superiority or Other|||||||0.003||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors.|ANCOVA|ANCOVA model that includes treatment as a factor and baseline OHQ composite score as a co-variate.|||
1714562|NCT00782288|3154926|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Baseline,Treatment and Recovery periods were compared to determine if changes from baseline differed between placebo and the two digitoxin doses.|
1714563|NCT00782288|3154932|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Measures were compared between Baseline, Treatment & Recovery periods to determine if changes from baseline differed between placebo and the two digitoxin dose levels. Kruskal-Wallis equity of population rank test was performed on the changes Day 28 minus Day 1. To compare the change from baseline to treatment period between the two arms, a Wilcoxon rank sum test was performed. To determine whether induced sputum Il-8 returned to baseline at the final visit, a one sample sign test was performed.|
1714564|NCT00782275|3154935|Superiority|||||||0.081|||||||exact binomial test|||The regimen was evaluated against an historical control with null and alternative 4-month PFS rates of 50% and 70%, respectively. With the final sample size of 40 eligible patients and using the same operating characteristics (alpha and beta 10%), the decision rule changes such that if 25 or more patients of 40 are alive and progression-free at 4 months then this regimen is considered promising.|
1714565|NCT00782210|3154938|Superiority or Other||Incidence rate ratio|0.8485|Standard Error of the Mean|0.1686||0.4086|2-Sided|95.0|0.5743|1.2535|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo||
1714566|NCT00782210|3154938|Superiority or Other||Incidence rate ratio|0.8081|Standard Error of the Mean|0.163||0.2911|2-Sided|95.0|0.5438|1.2008|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo||
1714567|NCT00782210|3154939|Superiority or Other||Incidence rate ratio|1.1211|Standard Error of the Mean|0.4103||0.755|2-Sided|95.0|0.5464|2.3003|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo||
1714568|NCT00782210|3154939|Superiority or Other||Incidence rate ratio|0.655|Standard Error of the Mean|0.2664||0.2985|2-Sided|95.0|0.2947|1.4556|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo||
1714569|NCT00782210|3154940|Superiority or Other||Incidence rate ratio|0.8456|Standard Error of the Mean|0.1467||0.3342|2-Sided|95.0|0.6015|1.1889|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 10 mcg qd minus Placebo||
1714570|NCT00782210|3154940|Superiority or Other||Incidence rate ratio|0.7815|Standard Error of the Mean|0.138||0.1631|2-Sided|95.0|0.5524|1.1054|||Negative binomial regression|Regression of treatment effect using tiotropium strata as a covariate, a log link function and log(exposure) as offset.|Olo 5 mcg qd minus Placebo||
1714571|NCT00782210|3154941|Superiority or Other||Hazard Ratio (HR)|0.811|Standard Error of the Mean|0.153||0.257|2-Sided|95.0|0.561|1.174|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum||
1714572|NCT00782210|3154941|Superiority or Other||Hazard Ratio (HR)|0.739|Standard Error of the Mean|0.142||0.1194|2-Sided|95.0|0.506|1.078|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum||
1714573|NCT00782210|3154942|Superiority or Other||Hazard Ratio (HR)|1.01|Standard Error of the Mean|0.342||0.9792|2-Sided|95.0|0.521|1.961|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum||
1714574|NCT00782210|3154942|Superiority or Other||Hazard Ratio (HR)|0.656|Standard Error of the Mean|0.247||0.2754|2-Sided|95.0|0.313|1.374|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum||
1714575|NCT00782210|3154943|Superiority or Other||Hazard Ratio (HR)|0.799|Standard Error of the Mean|0.133||0.1701|2-Sided|95.0|0.576|1.107|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 10 mcg qd to placebo across stratum||
1714576|NCT00782210|3154943|Superiority or Other||Hazard Ratio (HR)|0.728|Standard Error of the Mean|0.124||0.0658|2-Sided|95.0|0.522|1.016|||Regression, Cox|Model included a stratification factor for tiotropium use stratum and a covariate for treatment group|Comparison of Olo 5 mcg qd to placebo across stratum||
1714577|NCT00782210|3154944|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0031||95.0|-0.6|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo||
1714578|NCT00782210|3154944|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0109||95.0|-0.5|-0.1|||Mixed Models Analysis|Model included treatment, tiotropium stratum,visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo||
1714579|NCT00782210|3154945|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo||
1714580|NCT00782210|3154945|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo||
1714581|NCT00782210|3154946|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.6|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo||
1714582|NCT00782210|3154946|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.7|-0.2|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo||
1714583|NCT00782210|3154947|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.7|-0.3|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 10 mcg qd minus Placebo||
1714584|NCT00782210|3154947|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.7|-0.3|||Mixed Models Analysis|Model included treatment, tiotropium stratum, visit and treatment-by-visit interaction as fixed effects, patient as random.|Olo 5 mcg qd minus Placebo||
1714585|NCT00782210|3154948|Superiority or Other||Mean Difference (Final Values)|-1.435|Standard Error of the Mean|0.354|<|0.0001|2-Sided|95.0|-2.13|-0.74|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714586|NCT00782210|3154948|Superiority or Other||Mean Difference (Final Values)|-1.104|Standard Error of the Mean|0.354|<|0.0019|2-Sided|95.0|-1.799|-0.409|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714587|NCT00782210|3154949|Superiority or Other||Mean Difference (Final Values)|-0.792|Standard Error of the Mean|0.202||0.0001|2-Sided|95.0|-1.189|-0.394|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714588|NCT00782210|3154949|Superiority or Other||Mean Difference (Final Values)|-0.582|Standard Error of the Mean|0.202||0.0041|2-Sided|95.0|-0.979|-0.185|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714589|NCT00782210|3154950|Superiority or Other||Mean Difference (Final Values)|-0.648|Standard Error of the Mean|0.182||0.0004|2-Sided|95.0|-1.005|-0.291|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714590|NCT00782210|3154950|Superiority or Other||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.182||0.0045|2-Sided|95.0|-0.878|-0.162|||ANCOVA|non−MMRM ANCOVA models with treatment, tiotropium strata and baseline as fixed effects.|||
1714591|NCT00782210|3154951|Superiority or Other||Mean Difference (Final Values)|14.56|Standard Error of the Mean|4.226||0.0006|2-Sided|95.0|6.259|22.86|||ANCOVA|non−MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.|||
1714592|NCT00782210|3154951|Superiority or Other||Mean Difference (Final Values)|17.186|Standard Error of the Mean|4.245|<|0.0001|2-Sided|95.0|8.849|25.523|||ANCOVA|non−MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.|||
1714593|NCT00782210|3154952|Superiority or Other||Mean Difference (Final Values)|15.457|Standard Error of the Mean|4.248||0.0003|2-Sided|95.0|7.114|23.8|||ANCOVA|non−MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.|||
1714594|NCT00782210|3154952|Superiority or Other||Mean Difference (Final Values)|13.357|Standard Error of the Mean|4.253||0.0018|2-Sided|95.0|5.005|21.709|||ANCOVA|non−MMRM ANCOVA models by week, with treatment, tiotropium strata and baseline as fixed effects.|||
1714595|NCT00782210|3154953|Superiority or Other||Mean Difference (Final Values)|0.249|Standard Error of the Mean|0.061|<|0.0001||95.0|0.128|0.37|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo||
1714596|NCT00782210|3154953|Superiority or Other||Mean Difference (Final Values)|0.302|Standard Error of the Mean|0.061|<|0.0001||95.0|0.181|0.422|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo||
1714597|NCT00782210|3154954|Superiority or Other||Mean Difference (Final Values)|0.26|Standard Error of the Mean|0.041|<|0.0001||95.0|0.181|0.34|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714598|NCT00782210|3154954|Superiority or Other||Mean Difference (Final Values)|0.247|Standard Error of the Mean|0.04|<|0.0001||95.0|0.168|0.327|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714599|NCT00782210|3154955|Superiority or Other||Mean Difference (Final Values)|0.232|Standard Error of the Mean|0.04|<|0.0001||95.0|0.154|0.311|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714600|NCT00782210|3154955|Superiority or Other||Mean Difference (Final Values)|0.232|Standard Error of the Mean|0.04|<|0.0001||95.0|0.153|0.31|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714601|NCT00782210|3154956|Superiority or Other||Mean Difference (Final Values)|0.26|Standard Error of the Mean|0.04|<|0.0001||95.0|0.183|0.338|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714602|NCT00782210|3154956|Superiority or Other||Mean Difference (Final Values)|0.251|Standard Error of the Mean|0.04|<|0.0001||95.0|0.174|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714603|NCT00782210|3154957|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.039|<|0.0001||95.0|0.203|0.358|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714604|NCT00782210|3154957|Superiority or Other||Mean Difference (Final Values)|0.251|Standard Error of the Mean|0.039|<|0.0001||95.0|0.174|0.328|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714605|NCT00782210|3154958|Superiority or Other||Mean Difference (Final Values)|0.292|Standard Error of the Mean|0.039|<|0.0001||95.0|0.216|0.368|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714606|NCT00782210|3154958|Superiority or Other||Mean Difference (Final Values)|0.264|Standard Error of the Mean|0.039|<|0.0001||95.0|0.188|0.341|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714607|NCT00782210|3154959|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.039|<|0.0001||95.0|0.225|0.376|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714608|NCT00782210|3154959|Superiority or Other||Mean Difference (Final Values)|0.263|Standard Error of the Mean|0.039|<|0.0001||95.0|0.187|0.339|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714609|NCT00782210|3154960|Superiority or Other||Mean Difference (Final Values)|0.115|Standard Error of the Mean|0.038||0.0025||95.0|0.04|0.19|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714610|NCT00782210|3154960|Superiority or Other||Mean Difference (Final Values)|0.094|Standard Error of the Mean|0.038||0.0134||95.0|0.019|0.168|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714611|NCT00782210|3154961|Superiority or Other||Mean Difference (Final Values)|0.154|Standard Error of the Mean|0.038|<|0.0001||95.0|0.08|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714612|NCT00782210|3154961|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.038|<|0.0006||95.0|0.057|0.205|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714613|NCT00782210|3154962|Superiority or Other||Mean Difference (Final Values)|0.123|Standard Error of the Mean|0.038||0.0011||95.0|0.049|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714614|NCT00782210|3154962|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.038||0.0154||95.0|0.018|0.165|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714615|NCT00782210|3154963|Superiority or Other||Mean Difference (Final Values)|0.123|Standard Error of the Mean|0.037||0.001||95.0|0.05|0.197|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714616|NCT00782210|3154963|Superiority or Other||Mean Difference (Final Values)|0.083|Standard Error of the Mean|0.037||0.0261||95.0|0.01|0.156|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714617|NCT00782210|3154964|Superiority or Other||Mean Difference (Final Values)|0.162|Standard Error of the Mean|0.037|<|0.0001||95.0|0.089|0.235|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714618|NCT00782210|3154964|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.037|<|0.0005||95.0|0.057|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714619|NCT00782210|3154965|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.037|<|0.0001||95.0|0.088|0.233|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714620|NCT00782210|3154965|Superiority or Other||Mean Difference (Final Values)|0.115|Standard Error of the Mean|0.037|<|0.0019||95.0|0.043|0.187|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714621|NCT00782210|3154966|Superiority or Other||Mean Difference (Final Values)|0.141|Standard Error of the Mean|0.036||0.0001||95.0|0.069|0.213|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714622|NCT00782210|3154966|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.037||0.0003||95.0|0.059|0.203|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714785|NCT00780026|3155179|Superiority or Other|||||||0.585||||||P value for transplant incision wound|Chi-squared||||
1714786|NCT00780026|3155179|Superiority or Other|||||||0.298||||||P-value for fungal infection|Chi-squared||||
1714623|NCT00782210|3154967|Superiority or Other||Mean Difference (Final Values)|0.184|Standard Error of the Mean|0.036|<|0.0001||95.0|0.113|0.255|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714624|NCT00782210|3154967|Superiority or Other||Mean Difference (Final Values)|0.147|Standard Error of the Mean|0.036|<|0.0001||95.0|0.076|0.218|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714625|NCT00782210|3154968|Superiority or Other||Mean Difference (Final Values)|0.271|Standard Error of the Mean|0.038|<|0.0001||95.0|0.196|0.346|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714626|NCT00782210|3154968|Superiority or Other||Mean Difference (Final Values)|0.244|Standard Error of the Mean|0.038|<|0.0001||95.0|0.169|0.319|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714627|NCT00782210|3154969|Superiority or Other||Mean Difference (Final Values)|0.254|Standard Error of the Mean|0.038|<|0.0001||95.0|0.18|0.329|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714628|NCT00782210|3154969|Superiority or Other||Mean Difference (Final Values)|0.235|Standard Error of the Mean|0.038|<|0.0001||95.0|0.161|0.309|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714629|NCT00782210|3154970|Superiority or Other||Mean Difference (Final Values)|0.292|Standard Error of the Mean|0.037|<|0.0001||95.0|0.219|0.366|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714630|NCT00782210|3154970|Superiority or Other||Mean Difference (Final Values)|0.275|Standard Error of the Mean|0.037|<|0.0001||95.0|0.201|0.348|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714631|NCT00782210|3154971|Superiority or Other||Mean Difference (Final Values)|0.293|Standard Error of the Mean|0.037|<|0.0001||95.0|0.22|0.366|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714632|NCT00782210|3154971|Superiority or Other||Mean Difference (Final Values)|0.254|Standard Error of the Mean|0.037|<|0.0001||95.0|0.181|0.327|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714633|NCT00782210|3154972|Superiority or Other||Mean Difference (Final Values)|0.327|Standard Error of the Mean|0.037|<|0.0001||95.0|0.255|0.399|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714634|NCT00782210|3154972|Superiority or Other||Mean Difference (Final Values)|0.296|Standard Error of the Mean|0.037|<|0.0001||95.0|0.224|0.368|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714635|NCT00782210|3154973|Superiority or Other||Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.037|<|0.0001||95.0|0.258|0.401|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714636|NCT00782210|3154973|Superiority or Other||Mean Difference (Final Values)|0.288|Standard Error of the Mean|0.037|<|0.0001||95.0|0.216|0.359|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714637|NCT00782210|3154974|Superiority or Other||Mean Difference (Final Values)|0.163|Standard Error of the Mean|0.021|<|0.0001||95.0|0.121|0.205|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714638|NCT00782210|3154974|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.021|<|0.0001||95.0|0.128|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714639|NCT00782210|3154975|Superiority or Other||Mean Difference (Final Values)|0.151|Standard Error of the Mean|0.021|<|0.0001||95.0|0.11|0.192|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714640|NCT00782210|3154975|Superiority or Other||Mean Difference (Final Values)|0.175|Standard Error of the Mean|0.021|<|0.0001||95.0|0.134|0.216|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714641|NCT00782210|3154976|Superiority or Other||Mean Difference (Final Values)|0.165|Standard Error of the Mean|0.021|<|0.0001||95.0|0.124|0.206|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714642|NCT00782210|3154976|Superiority or Other||Mean Difference (Final Values)|0.164|Standard Error of the Mean|0.021|<|0.0001||95.0|0.123|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714643|NCT00782210|3154977|Superiority or Other||Mean Difference (Final Values)|0.172|Standard Error of the Mean|0.021|<|0.0001||95.0|0.132|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714717|NCT00781937|3155056|Superiority or Other||Treatment Contrast|-5.86|||<|0.0001||95.0|-7.3|-4.43||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714644|NCT00782210|3154977|Superiority or Other||Mean Difference (Final Values)|0.172|Standard Error of the Mean|0.021|<|0.0001||95.0|0.132|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714645|NCT00782210|3154978|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.02|<|0.0001||95.0|0.15|0.23|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714646|NCT00782210|3154978|Superiority or Other||Mean Difference (Final Values)|0.177|Standard Error of the Mean|0.02|<|0.0001||95.0|0.137|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714647|NCT00782210|3154979|Superiority or Other||Mean Difference (Final Values)|0.171|Standard Error of the Mean|0.02|<|0.0001||95.0|0.131|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714648|NCT00782210|3154979|Superiority or Other||Mean Difference (Final Values)|0.155|Standard Error of the Mean|0.02|<|0.0001||95.0|0.115|0.194|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714649|NCT00782210|3154980|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.019|<|0.0001||95.0|0.053|0.129|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714650|NCT00782210|3154980|Superiority or Other||Mean Difference (Final Values)|0.092|Standard Error of the Mean|0.019|<|0.0001||95.0|0.055|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714651|NCT00782210|3154981|Superiority or Other||Mean Difference (Final Values)|0.105|Standard Error of the Mean|0.019|<|0.0001||95.0|0.068|0.143|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714652|NCT00782210|3154981|Superiority or Other||Mean Difference (Final Values)|0.107|Standard Error of the Mean|0.019|<|0.0001||95.0|0.069|0.145|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714653|NCT00782210|3154982|Superiority or Other||Mean Difference (Final Values)|0.085|Standard Error of the Mean|0.019|<|0.0001||95.0|0.048|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714654|NCT00782210|3154982|Superiority or Other||Mean Difference (Final Values)|0.092|Standard Error of the Mean|0.019|<|0.0001||95.0|0.054|0.13|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714655|NCT00782210|3154983|Superiority or Other||Mean Difference (Final Values)|0.089|Standard Error of the Mean|0.019|<|0.0001||95.0|0.051|0.126|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714656|NCT00782210|3154983|Superiority or Other||Mean Difference (Final Values)|0.086|Standard Error of the Mean|0.019|<|0.0001||95.0|0.049|0.123|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714657|NCT00782210|3154984|Superiority or Other||Mean Difference (Final Values)|0.101|Standard Error of the Mean|0.019|<|0.0001||95.0|0.064|0.138|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714658|NCT00782210|3154984|Superiority or Other||Mean Difference (Final Values)|0.098|Standard Error of the Mean|0.019|<|0.0001||95.0|0.061|0.135|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714659|NCT00782210|3154985|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.019|<|0.0001||95.0|0.054|0.127|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714660|NCT00782210|3154985|Superiority or Other||Mean Difference (Final Values)|0.095|Standard Error of the Mean|0.019|<|0.0001||95.0|0.059|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714661|NCT00782210|3154986|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|0.018|<|0.0001||95.0|0.075|0.147|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714662|NCT00782210|3154986|Superiority or Other||Mean Difference (Final Values)|0.095|Standard Error of the Mean|0.018|<|0.0001||95.0|0.059|0.131|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714663|NCT00782210|3154987|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.02|<|0.0001||95.0|0.131|0.208|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714664|NCT00782210|3154987|Superiority or Other||Mean Difference (Final Values)|0.173|Standard Error of the Mean|0.019|<|0.0001||95.0|0.134|0.211|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714787|NCT00780026|3155179|Superiority or Other|||||||0.841||||||P value for Bacterial infection|Chi-squared||||
1714788|NCT00779870|3155190|Superiority|||||||0.8|||||||t-test, 2 sided||||
1714665|NCT00782210|3154988|Superiority or Other||Mean Difference (Final Values)|0.161|Standard Error of the Mean|0.019|<|0.0001||95.0|0.123|0.199|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714666|NCT00782210|3154988|Superiority or Other||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.019|<|0.0001||95.0|0.136|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714667|NCT00782210|3154989|Superiority or Other||Mean Difference (Final Values)|0.167|Standard Error of the Mean|0.019|<|0.0001||95.0|0.13|0.204|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714668|NCT00782210|3154989|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.019|<|0.0001||95.0|0.133|0.207|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714669|NCT00782210|3154990|Superiority or Other||Mean Difference (Final Values)|0.192|Standard Error of the Mean|0.019|<|0.0001||95.0|0.156|0.229|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714670|NCT00782210|3154990|Superiority or Other||Mean Difference (Final Values)|0.181|Standard Error of the Mean|0.019|<|0.0001||95.0|0.144|0.217|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714671|NCT00782210|3154991|Superiority or Other||Mean Difference (Final Values)|0.175|Standard Error of the Mean|0.019|<|0.0001||95.0|0.139|0.212|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714672|NCT00782210|3154991|Superiority or Other||Mean Difference (Final Values)|0.165|Standard Error of the Mean|0.019|<|0.0001||95.0|0.128|0.201|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714673|NCT00782210|3154992|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.031|<|0.0001||95.0|0.108|0.229|||Mixed Models Analysis|Treatment, tiotropium stratum and baseline as fixed effects|Olo 10 mcg qd minus Placebo||
1714674|NCT00782210|3154992|Superiority or Other||Mean Difference (Final Values)|0.173|Standard Error of the Mean|0.031|<|0.0001||95.0|0.113|0.233|||ANCOVA|Treatment, tiotropium stratum and baseline as fixed effects|Olo 5 mcg qd minus Placebo||
1714675|NCT00782210|3154993|Superiority or Other||Mean Difference (Final Values)|0.101|Standard Error of the Mean|0.019|<|0.0001||95.0|0.064|0.137|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714676|NCT00782210|3154993|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.019|<|0.0001||95.0|0.054|0.128|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714677|NCT00782210|3154994|Superiority or Other||Mean Difference (Final Values)|0.176|Standard Error of the Mean|0.019|<|0.0001||95.0|0.139|0.214|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 10 mcg qd minus Placebo||
1714678|NCT00782210|3154994|Superiority or Other||Mean Difference (Final Values)|0.172|Standard Error of the Mean|0.019|<|0.0001||95.0|0.135|0.209|||Mixed Models Analysis|Mixed effects model with trt,tio stratum,visit,trt-by-visit as fixed effects,baseline, baseline-by-visit as fixed covariates, patient as random effect|Olo 5 mcg qd minus Placebo||
1714679|NCT00782184|3154995|Superiority or Other||Difference in Least Squares Means|2.68||||0.785|2-Sided|95.0|-16.5|21.86|||LDA Model||||
1714680|NCT00782184|3154996|Superiority or Other||Difference in Least Squares Means|-12.91|||<|0.001|2-Sided|95.0|-18.31|-7.52|||LDA Model||||
1714681|NCT00782184|3154997|Superiority or Other||Difference in Least Squares Means|5.25|||<|0.001|2-Sided|95.0|2.44|8.06|||LDA Model||||
1714682|NCT00782184|3154998|Superiority or Other||Difference in Least Squares Means|-7.69||||0.002|2-Sided|95.0|-12.5|-2.88|||LDA Model||||
1714683|NCT00782184|3154999|Superiority or Other||Difference in Least Squares Means|-13.21|||<|0.001|2-Sided|95.0|-19.83|-6.59|||LDA Model||||
1714684|NCT00782184|3155000|Superiority or Other||Difference in Least Squares Means|-10.02|||<|0.001|2-Sided|95.0|-14.96|-5.08|||LDA Model||||
1714685|NCT00782184|3155001|Superiority or Other||Difference in Least Squares Means|-16.1|||<|0.001|2-Sided|95.0|-22.77|-9.44|||LDA Model||||
1714686|NCT00782184|3155002|Superiority or Other||Difference in Least Squares Means|-11.62|||<|0.001|2-Sided|95.0|-17.32|-5.92|||LDA Model||||
1714687|NCT00782184|3155003|Superiority or Other||Difference in Least Squares Means|2.48||||0.211|2-Sided|95.0|-1.41|6.37|||LDA Model||||
1714688|NCT00782184|3155004|Superiority or Other||Difference in Least Squares Means|2.13||||0.593|2-Sided|95.0|-5.67|9.93|||LDA Model||||
1714689|NCT00782184|3155005|Superiority or Other||Difference in Least Squares Means|-8.24|||<|0.001|2-Sided|95.0|-12.5|-3.97|||LDA Model||||
1714690|NCT00782184|3155006|Superiority or Other||Odds Ratio (OR)|3.5|||<|0.001|2-Sided|95.0|2.0|6.0|||Regression, Logistic||||
1714691|NCT00782184|3155007|Superiority or Other||Odds Ratio (OR)|6.7|||<|0.001|2-Sided|95.0|3.3|13.9|||Regression, Logistic||||
1714692|NCT00782184|3155008|Superiority or Other||Difference in Least Squares Means|-15.0|||<|0.001|2-Sided|95.0|-21.15|-8.84|||Longitudinal Data Analysis (LDA) Model||||
1714693|NCT00782184|3155009|Superiority or Other||Odds Ratio (OR)|8.4|||<|0.001|2-Sided|95.0|3.4|21.0|||Regression, Logistic|||COMPARISON BETWEEN GROUPS FOR NUMBER OF PARTICIPANTS REACHING LDL-C GOAL OF <70 MG/DL|
1714694|NCT00782067|3155030|Other|Single arm study|||||<|0.001||||||Null hypothesis: ORR <= 30% Alternative hypothesis: ORR >= 50%|Exact Binomial Test||||Exact Binomial 95% Confidence Interval
1714789|NCT00779870|3155190|Superiority|||||||0.06|||||||t-test, 2 sided||||
1714695|NCT00781963|3155031|Superiority||Mean Difference (Final Values)|-2.4|Standard Error of the Mean|0.55|<|0.001|2-Sided|95.0|-3.5|-1.3|||Mixed Models Analysis||The parameter estimate is the improvement in PSQI score from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.||
1714696|NCT00781963|3155032|Superiority||Mean Difference (Final Values)|-1.4|Standard Error of the Mean|0.97||0.15|2-Sided|95.0|-3.3|0.5|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency (from wrist actigraphy) from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.||
1714697|NCT00781963|3155033|Superiority||Mean Difference (Final Values)|6.7|Standard Error of the Mean|2.36||0.005|2-Sided|95.0|2.0|11.3|||Mixed Models Analysis||The parameter estimate is the improvement in sleep efficiency from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.||
1714698|NCT00781963|3155034|Superiority||Mean Difference (Final Values)|-37.0|Standard Error of the Mean|12.9||0.004|2-Sided|95.0|-62.2|-11.7|||Mixed Models Analysis||The parameter estimate is the improvement in total wake time from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.||
1714699|NCT00781963|3155035|Superiority||Mean Difference (Final Values)|-10.2|Standard Error of the Mean|8.2||0.21|2-Sided|95.0|-26.3|5.9|||Mixed Models Analysis||The parameter estimate is the improvement in wake after sleep onset from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.||
1714700|NCT00781963|3155036|Superiority||Mean Difference (Final Values)|-15.8|Standard Error of the Mean|6.6|<|0.001|2-Sided|95.0|-28.7|-3.0|||Mixed Models Analysis||The parameter estimate is the improvement in sleep onset latency from baseline to 6-month follow-up for CBT-I group versus the same improvement in the control group.||
1714701|NCT00781937|3155041|Superiority or Other||Treatment Contrast|-0.27|||<|0.0001||95.0|-0.33|-0.21||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714702|NCT00781937|3155042|Superiority or Other||Treatment Contrast|-1.85||||0.0147||95.0|-3.34|-0.37||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714703|NCT00781937|3155043|Superiority or Other||Treatment Contrast|-0.38|||<|0.0001||95.0|-0.5|-0.26||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714704|NCT00781937|3155044|Superiority or Other||Treatment Contrast|-0.1||||0.0053||95.0|-0.16|-0.03||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714705|NCT00781937|3155045|Superiority or Other||Treatment Contrast|2.35||||0.3689||95.0|-2.79|7.49||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714706|NCT00781937|3155046|Superiority or Other||Treatment Contrast|-2.05|||<|0.0001||95.0|-2.53|-1.57||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714707|NCT00781937|3155047|Superiority or Other||Treatment Contrast|-3.5|||<|0.0001||95.0|-4.84|-2.15||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714708|NCT00781937|3155048|Superiority or Other||Odds Ratio (OR)|0.64||||0.1199||95.0|0.36|1.12||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, and stratification factor(s) as fixed effects and metabolic status and weight at baseline as covariates.|||
1714709|NCT00781937|3155049|Superiority or Other||Treatment Contrast|-13.01||||0.0141||95.0|-23.4|-2.64||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714710|NCT00781937|3155050|Superiority or Other||Treatment Contrast|-0.11||||0.1149||95.0|-0.24|0.03||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714711|NCT00781937|3155051|Superiority or Other||Treatment Contrast|-0.09||||0.1098||95.0|-0.2|0.02||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714712|NCT00781937|3155052|Superiority or Other||Treatment Contrast|-0.11||||0.031||95.0|-0.2|-0.01||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714713|NCT00781937|3155053|Superiority or Other||Treatment Contrast|0.97||||0.1968||95.0|-0.51|2.45||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714714|NCT00781937|3155054|Superiority or Other||Treatment Contrast|-0.34||||0.6386||95.0|-1.74|1.07||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||Analysis is of treatment contrast, change in diastolic blood pressure.|
1714715|NCT00781937|3155054|Superiority or Other||Treatment Contrast|-2.72||||0.0068||95.0|-4.69|-0.76||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||Analysis is of treatment contrast, change in systolic blood pressure.|
1714716|NCT00781937|3155055|Superiority or Other||Treatment Contrast|-4.23|||<|0.0001||95.0|-6.04|-2.43||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.|||
1714820|NCT00778258|3155386|Superiority or Other||||||<|0.01|||||||Chi-squared|||36 Month Comparison|
1714718|NCT00781937|3155057|Superiority or Other||Odds Ratio (OR)|6.02|||<|0.0001||95.0|3.65|9.92||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.|||
1714719|NCT00781937|3155058|Superiority or Other||Odds Ratio (OR)|5.86|||<|0.0001||95.0|3.12|10.98||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.|||
1714720|NCT00781937|3155060|Superiority or Other||Odds Ratio (OR)|0.09|||<|0.0001||95.0|0.03|0.26||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.|||
1714721|NCT00781937|3155061|Superiority or Other||Odds Ratio (OR)|5.3|||<|0.0001||95.0|2.79|10.08||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.|||
1714722|NCT00781937|3155062|Superiority or Other||Odds Ratio (OR)|3.86|||<|0.0001||95.0|2.44|6.09||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.|
1714723|NCT00781937|3155063|Superiority or Other||Odds Ratio (OR)|4.82|||<|0.0001||95.0|3.01|7.71||Two sided, conducted at a 5% significance level|Regression, Logistic|The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.|
1714724|NCT00781937|3155064|Superiority or Other||Treatment Contrast|-6.06|||<|0.0001||95.0|-7.5|-4.62||Two sided, conducted at a 5% significance level|ANCOVA|The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.||The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3) and the hypotheses of equality between liraglutide and placebo for each were tested in a hierarchical manner; i.e. a conclusion of liraglutide superiority for a given co-primary endpoint could be drawn only if all preceding hypotheses of equality in the hierarchy had been rejected.|
1714725|NCT00781859|3155078|Superiority or Other||Odds Ratio (OR)|2.56||||0.003|2-Sided|95.0|1.32|5.24||comparing placebo and ocriplasmin|Fisher Exact||||
1714726|NCT00781768|3155079|Superiority||Odds Ratio (OR)|2.3|||<|0.001|2-Sided||||||Chi-squared|||The null hypothesis is that there will be a higher proportion of complete responders among those subjects receiving the combination therapy.|
1714727|NCT00781456|3155090|Superiority or Other|||||||0.709|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the 91-day treatment period.|
1714728|NCT00781456|3155090|Superiority or Other|||||||0.018|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the third month of treatment.|
1714729|NCT00781456|3155090|Superiority or Other|||||||0.361|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the second month of treatment.|
1714730|NCT00781456|3155090|Superiority or Other|||||||0.457|||||||Cochran-Mantel-Haenszel|||Comparison of percentage of participants requiring rescue medication during the first month of treatment.|
1714731|NCT00781456|3155091|Superiority or Other||Odds Ratio, log|-0.4||||0.119|2-Sided|95.0|-0.9|0.1|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the third month of treatment|
1714732|NCT00781456|3155091|Superiority or Other||Odds Ratio, log|-0.26||||0.249|2-Sided|95.0|-0.71|0.19|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the second month of treatment|
1714733|NCT00781456|3155091|Superiority or Other||Odds Ratio, log|-0.04||||0.853|2-Sided|95.0|-0.71|0.19|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the first month of treatment|
1714734|NCT00781456|3155091|Superiority or Other||Odds Ratio, log|-0.19||||0.182|2-Sided|95.0|-0.47|0.09|||ANCOVA|Treatment comparison was performed using an analysis of covariance model with baseline average migraine severity and center as covariates.|91-day Levonogestrel Oral Contraceptive versus placebo.|Comparison of change from Baseline in migraine severity during the 91-day treatment period.|
1714735|NCT00781456|3155092|Superiority or Other||Odds Ratio, log|-0.14|Standard Error of the Mean|0.52||0.788|2-Sided|95.0|-1.16|0.88||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with >=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the third month of treatment.|
1714751|NCT00781391|3155101|Non-Inferiority or Equivalence|If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.|Hazard Ratio (HR)|1.13||||0.0074|2-Sided|97.5|0.955|1.336|||Cox proportional hazards model|||Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.|
1714736|NCT00781456|3155092|Superiority or Other||Odds Ratio, log|0.5|Standard Error of the Mean|0.44||0.256|2-Sided|95.0|-0.36|1.37||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with >=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the second month of treatment|
1714737|NCT00781456|3155092|Superiority or Other||Odds Ratio, log|0.31|Standard Error of the Mean|0.44||0.479|2-Sided|95.0|-0.55|1.17||No adjustment for multiple comparisons was performed.|Regression, Logistic|Logistic regression model with terms of treatment, baseline weekly migraine frequency and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with >=50% reduction in migraine frequency during the treatment period.|Comparison of percentage of participants with a reduction of 50% or more in migraine frequency during the first month of treatment.|
1714738|NCT00781456|3155093|Superiority or Other||Odds Ratio, log|0.02|Standard Error of the Mean|0.43||0.954|2-Sided|95.0|-0.82|0.87|||Regression, Logistic|Logistic regression model with terms of treatment, weekly baseline migraine frequency, and center included in the model.|91-day Levonogestrel Oral Contraceptive versus placebo. Treatment Difference was estimated using logistic regression for the proportion of participants with >=50% reduction in migraine frequency during the treatment period.||
1714739|NCT00781391|3155094|Superiority or Other||Cox Proportional Hazard|0.62|||<|0.0001|2-Sided|95.0|0.575|0.666|||Regression, Cox|||Major or Clinically Relevant Non-Major, low dose vs. warfarin|
1714740|NCT00781391|3155094|Superiority or Other||Cox Proportional Hazard|0.86|||<|0.0001|2-Sided|95.0|0.8|0.918|||Regression, Cox|||Major or Clinically Relevant Non-Major, high dose vs. warfarin|
1714741|NCT00781391|3155094|Superiority or Other||Cox Proportional Hazard|0.47|||<|0.0001|2-Sided|95.0|0.406|0.548|||Regression, Cox|||"All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period.~The HR, two-sided CI, and p-value for pairwise comparisons versus Warfarin are based on the Cox regression model with counting process approach for on-treatment including treatment and the two stratification factors as covariates: the dichotomized CHADS2 score and the dichotomized dose-adjustment factor"|
1714742|NCT00781391|3155094|Superiority or Other||Cox Proportional Hazard|0.8|||<|0.0009|2-Sided|95.0|0.707|0.914|||Regression, Cox|||All Major Adjudicated Bleeding Events, Safety Analysis Set On-treatment period|
1714743|NCT00781391|3155095|Superiority or Other||Hazard Ratio (HR)|0.9||||0.0168|2-Sided|95.0|0.823|0.981|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.|
1714744|NCT00781391|3155096|Superiority or Other||Hazard Ratio (HR)|0.89||||0.0109|2-Sided|95.0|0.806|0.972|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.|
1714745|NCT00781391|3155097|Superiority or Other||Hazard Ratio (HR)|0.87||||0.0053|2-Sided|95.0|0.786|0.959|||Log Rank|||the time to first event was estimated by a KM estimate and was compared between the edoxaban 60 mg group and the warfarin group using a log-rank test at a pairwise comparison significance level of α=0.01.|
1714746|NCT00781391|3155098|Superiority or Other||Hazard Ratio (HR)|0.87||||0.081|2-Sided|99.0|0.709|1.068|||Log Rank|||The superiority analysis included the ITT analysis set|
1714747|NCT00781391|3155099|Non-Inferiority or Equivalence|"In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.~If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group."|Hazard Ratio (HR)|1.13||||0.0084|2-Sided|97.5|0.958|1.34|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.|
1714748|NCT00781391|3155099|Non-Inferiority or Equivalence|"In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.~If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group."|Hazard Ratio (HR)|0.86|||<|0.0001|2-Sided|97.5|0.72|1.032|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on-treatment and overall study period, although mITT on-treatment was considered primary.|
1714749|NCT00781391|3155100|Non-Inferiority or Equivalence|The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.|Hazard Ratio (HR)|1.08||||0.0064|2-Sided|97.5|0.878|1.32|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.|
1714750|NCT00781391|3155100|Non-Inferiority or Equivalence|The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively|Hazard Ratio (HR)|0.79|||<|0.0001|2-Sided|97.5|0.634|0.989|||Cox proportional hazards model|||The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.|
1714778|NCT00780026|3155173|Superiority or Other|||||||0.999|||||||Fisher Exact||||
1714779|NCT00780026|3155174|Superiority or Other|||||||0.137||||||This is the p value for Biliary Stricture|Chi-squared||||
1714780|NCT00780026|3155174|Superiority or Other|||||||0.826||||||P value for bile leak|Chi-squared||||
1714752|NCT00781391|3155101|Non-Inferiority or Equivalence|If the upper limit of this CI of the hazard ratio was below 1.38, then non-inferiority to warfarin was considered established for the edoxaban treatment group.|Hazard Ratio (HR)|0.86|||<|0.0001|2-Sided|97.5|0.719|1.029|||Cox proportional hazards model|||Non-inferiority or equivalence analysis; Non-inferiority analysis. The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary.|
1714753|NCT00781391|3155102|Non-Inferiority or Equivalence|The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary|Hazard Ratio (HR)|1.07||||0.0055|2-Sided|97.5|0.874|1.314||Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.|Cox proportional hazards model|||The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.|
1714754|NCT00781391|3155102|Non-Inferiority or Equivalence|The non-inferiority analysis included the mITT and PP analysis sets for both the on treatment and overall study period, although mITT on-treatment was considered primary|Hazard Ratio (HR)|0.79|||<|0.0001|2-Sided|97.5|0.632|0.985||Two stratification factor covariates: 1) CHADS2 score 2) dose-adjustment factor. If upper limit of CI of HR was below 1.38, then non-inferiority to warfarin was established for group.|Cox proportional hazards model|||The primary efficacy endpoint, time to the first occurrence of stroke/SEE, was first compared concurrently between each of the 2 edoxaban groups and warfarin group using the mITT Analysis Set in the on-treatment period for non-inferiority. In order to control the study-wise type-I error rate of two-sided α=0.05 for non-inferiority, each of these 2 comparisons were performed at the statistical significance level of two-sided α=0.025, respectively.|
1714755|NCT00781079|3155108|Superiority||Z test if ref coeff is diff than 0|0.03||||0.98|2-Sided||||||Regression, Linear||||
1714756|NCT00781079|3155109|Superiority||Z test if reg coeff is diff than 0|-0.16||||0.87|2-Sided||||||Regression, Linear||||
1714757|NCT00781079|3155110|Superiority||Z test if reg coeff is diff from 0|0.56||||0.58|2-Sided||||||Regression, Linear||||
1714758|NCT00781079|3155111|Superiority or Other|||||||0.05||||||Models included site, age, race, ethnicity. This is the calculated p value.|Regression, Linear|||comparisons between the PS and Usual Care groups were completed with a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.|
1714759|NCT00781079|3155112|Superiority||Z tests if Reg coeff are diff from 0|-0.58||||0.56|2-Sided||||||Regression, Linear||||
1714760|NCT00781079|3155113|Superiority or Other|||||||0.5||||||Models included site, age, race, ethnicity.|Regression, Linear|||comparisons between the PS and Usual Care groups were completed with a regression testing the interaction of group (PS vs Usual Care) and time (baseline vs follow-up) for the outcome measure. The measure was analyzed with mixed effect hierarchical regressions which accounted for the nesting of site under treatment, subjects within sites, and subjects over time.|
1714761|NCT00780962|3155114|Superiority||Percentage Difference|0.6|||>|0.5|2-Sided|95.0|-4.8|6.0|||Wald|||"The study was powered to find a 10% absolute risk reduction in the rate of contrast-induced nephropathy (a=.05, 90% power). We initially estimated the need for 600 patients and repowered to 800 patients after the 1st interim analysis. The study was halted for futility at the 2nd interim analysis.~Reported here 357 (89.4%) of the 399 enrolled subjects who completed a second blood draw at the time the study closed."|
1714762|NCT00780741|3155118|Superiority or Other||Mean Difference (Final Values)|-3.0|||<|0.0001|2-Sided|95.0|-4.0|-1.8|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the average months of symptoms in immediate group minus average months of symptoms in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.||
1714763|NCT00780741|3155119|Superiority or Other||Mean Difference (Net)|-139.0||||0.24|2-Sided|95.0|-377.0|94.0|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the average cost in immediate group minus average cost in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.||
1714764|NCT00780741|3155120|Superiority or Other||Mean Difference (Final Values)|0.1||||0.09|2-Sided|95.0|-0.01|0.21|||Point estimate on mean difference|Bootstrap sampling with replacement (N=10,000) was used to calculate the 95% confidence interval.|Mean difference calculated as the proportion with success in immediate group minus proportion with success in deferred group. 95% confidence interval obtained using bootstrap sampling with replacement.||
1714765|NCT00780572|3155123|Superiority or Other||Cox Proportional Hazard|0.9396||||0.668|2-Sided|95.0|0.7068|1.249|||Regression, Cox||||
1714766|NCT00780403|3155151|Superiority or Other||||||<|0.0001||||||Statistical tests were performed at the significance level of 5%, without multiplicity adjustment.|Mainland-Gart Test|The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.||The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.|
1714767|NCT00780338|3155153|Superiority or Other|||||||0.02||||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.|
1714781|NCT00780026|3155175|Superiority or Other|||||||0.401|||||||Fisher Exact||||
1715874|NCT00764478|3157483|Superiority or Other|||||||0.0692|||||||Cochran-Mantel-Haenszel|||Day 4|
1714768|NCT00780338|3155154|Superiority or Other|||||||0.61||||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|
1714769|NCT00780338|3155155|Superiority or Other|||||||0||||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.|
1714770|NCT00780338|3155156|Superiority or Other|||||||0.65||||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|
1714771|NCT00780338|3155157|Superiority or Other|||||||0.45||||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|
1714772|NCT00780338|3155158|Superiority or Other|||||||0||||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.|
1714773|NCT00780338|3155159|Superiority or Other|||||||0.01||||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.|
1714774|NCT00780338|3155160|Superiority or Other|||||||0.09||||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||Mirroring the intent-to-treat analysis (but comparing AGTO users to AGTO non users instead), we fitted a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time.|
1714775|NCT00780338|3155161|Superiority or Other|||||||0.61||||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|
1714776|NCT00780338|3155163|Superiority or Other|||||||0.58||||||The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|Linear Growth Models|||We first conducted an intent-to-treat analysis by fitting a model with two sets of random effects, one for matched coalitions and one with random intercepts and linear functions of time to account for trajectories of repeated observations within respondent. The model included three fixed effect terms: group (AGTO vs. control), time (Baseline=0 years, Mid=1 year, Post=2 years), and an interaction between group and time. We report the interaction p value here.|
1714777|NCT00780234|3155167|Other||Regression model parameter (α1)|-0.4|Standard Error of the Mean|0.63||0.53|2-Sided|95.0|-1.68|0.89|||Regression, Linear|The estimates of treatment effect were adjusted for baseline histology values.||"The hypotheses tested were:~H0: α1 = 0 vs H1: α1 ~= 0"|The hypothesis test was a 2-sided t-test of the effect of group (i.e. the difference between the pioglitazone and placebo groups). The general form of the model is Y = α0 + α1GROUP + α2BASELINE. Y represents the 6-month value of the dependent variable (summary of the histology), GROUP represents a classification variable for the treatment group (1=pioglitazone, 2=placebo), BASELINE represents the value of the outcome measure at baseline, and α0, α1 and α2 represent the parameter estimates from the general linear model. The test of the difference between groups will be the formal test of significance of the α1 parameter.
1714790|NCT00779402|3155284|Other||Hazard Ratio (HR)|0.997||||0.65|2-Sided|95.0|0.693|1.433|||Log Rank|Log Rank Test (two sided) stratified by Gleason Score and Radiation Therapy|||
1714791|NCT00779246|3155296|Superiority or Other||Odds Ratio (OR)|1.1|||>|0.05|2-Sided|95.0|0.5|2.9|||Regression, Logistic|||Null hypothesis was that ASC and CHG would be no different in preventing acquisition of MRSA.|
1714792|NCT00779116|3155301|Superiority or Other||||||<|0.0001||||||Statistical tests were performed atthe significance level of 5%, without multiplicity adjustment.|Mainland-Gart Test|The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.||The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.|
1714793|NCT00778869|3155339|Superiority or Other||||||<|0.05|||||||Student t-test||||
1714794|NCT00778830|3155343|Superiority or Other||Odds Ratio (OR)|1.3176|||||2-Sided|95.0|0.8078|2.1491|||||||
1714795|NCT00778648|3155357|Superiority or Other|||||||0.023|||||||ANOVA||||
1714796|NCT00778622|3155368|Superiority or Other|||||||0.6546||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided||||
1714797|NCT00778622|3155368|Superiority or Other|||||||0.2507||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided||||
1714798|NCT00778622|3155368|Superiority or Other|||||||0.021||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in TG at Week 16 was dependent variable, BMI was fixed main effect, baseline TG was covariate.|||
1714799|NCT00778622|3155369|Superiority or Other|||||||0.4071||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided||||
1714800|NCT00778622|3155369|Superiority or Other|||||||0.4066||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided||||
1714801|NCT00778622|3155369|Superiority or Other|||||||0.1431||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in HDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline HDL-C was covariate.|||
1714802|NCT00778622|3155370|Superiority or Other|||||||0.1295||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided||||
1714803|NCT00778622|3155370|Superiority or Other|||||||0.0526||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided||||
1714804|NCT00778622|3155370|Superiority or Other|||||||0.4508||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in LDL-C at Week 16 was dependent variable, BMI was fixed main effect, baseline LDL-C was covariate.|||
1714805|NCT00778622|3155371|Superiority or Other|||||||0.0422||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided||||
1714806|NCT00778622|3155371|Superiority or Other|||||||0.008||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity. For lipids, no comparison between overweight and obese was performed.|t-test, 2 sided||||
1714807|NCT00778622|3155371|Superiority or Other|||||||0.0305||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in TC at Week 16 was dependent variable, BMI was fixed main effect, baseline TC was covariate.|||
1714808|NCT00778622|3155372|Superiority or Other|||||||0.9145||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided||||
1714809|NCT00778622|3155372|Superiority or Other|||||||0.5305||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided||||
1714810|NCT00778622|3155372|Superiority or Other|||||||0.4696||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided||||
1714811|NCT00778622|3155372|Superiority or Other|||||||0.4614||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in FPG at Week 16 was dependent variable, BMI was fixed main effect, baseline FPG was covariate.|||
1714812|NCT00778622|3155373|Superiority or Other|||||||0.3589||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided||||
1714813|NCT00778622|3155373|Superiority or Other|||||||0.0232||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided||||
1714814|NCT00778622|3155373|Superiority or Other|||||||0.1984||||||Interpretation of two-by-two comparison based on 2-sided 5% significance level without correction for multiplicity.|t-test, 2 sided||||
1714815|NCT00778622|3155373|Superiority or Other|||||||0.0806||||||Interpretation based on 2-sided 5% significance level.|ANCOVA|Change from baseline in HbA1c at Week 16 was dependent variable, BMI was fixed main effect, baseline HbA1c was covariate.||"Standard deviation assumed for changes from baseline in HbA1c maximally was 1.0 across the baseline BMI subgroups. 97 participants in a single subgroup would be sufficient to estimate mean change in HbA1c with precision of 0.20% within the subgroup. Given number of baseline BMI subgroups and no correction for reason of multiplicity was made to the 95% CI within each BMI subgroup, total sample size calculated as 291. Sample size used the method CI for mean for one group in nQuery Advisor v6.0."|
1714816|NCT00778336|3155382|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion > 0.|||
1714817|NCT00778336|3155382|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion > 0.|||
1714818|NCT00778336|3155382|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion > 0.|||
1714819|NCT00778336|3155382|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Alternative hypothesis is change in occlusion > 0.|||
1714828|NCT00778258|3155389|Superiority or Other|||||||0.22||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Max Basophil Assessment|
1714829|NCT00778258|3155389|Superiority or Other|||||||0.01|||||||Kruskal-Wallis|||Analysis on Max Basophil Assessment|
1714830|NCT00778258|3155390|Superiority or Other||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Cow’s Milk IgE|
1714831|NCT00778258|3155390|Superiority or Other||||||<|0.01|||||||Kruskal-Wallis|||Analysis on Cow’s Milk IgE|
1714832|NCT00778258|3155390|Superiority or Other||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Casein IgE|
1714833|NCT00778258|3155390|Superiority or Other||||||<|0.01|||||||Kruskal-Wallis|||Analysis on Casein IgE|
1714834|NCT00778258|3155390|Superiority or Other||||||<|0.01||||||Null hypothesis is that correlation = 0|Spearman Correlation|||Analysis on Betalactoglobulin IgE|
1714835|NCT00778258|3155390|Superiority or Other||||||<|0.01|||||||Kruskal-Wallis|||Analysis on Betalactoglobulin|
1714836|NCT00778258|3155391|Superiority or Other|||||||0.01||||||Null hypothesis is that correlation = 0|Spearman’s Correlation||||
1714837|NCT00778258|3155391|Superiority or Other|||||||0.09|||||||Kruskal-Wallis||||
1714838|NCT00778258|3155392|Superiority or Other|||||||0.41|||||||Chi-squared||||
1714839|NCT00778258|3155393|Superiority or Other|||||||0.33|||||||Chi-squared|||Comparison at 36 Months|
1714840|NCT00778258|3155393|Superiority or Other|||||||0.17|||||||Chi-squared|||Comparison at 24 Months|
1714841|NCT00778258|3155393|Superiority or Other|||||||0.14|||||||Chi-squared|||Comparison at 12 Months|
1714842|NCT00778258|3155394|Superiority or Other||Odds Ratio, log|0.81||||0.62|2-Sided|95.0|0.34|1.91|||Chi-squared|||Progression comparison at 24 Months|
1714843|NCT00778258|3155394|Superiority or Other||Odds Ratio, log|1.13||||0.78|2-Sided|95.0|0.48|2.68|||Chi-squared|||Progression comparison at 12 Months|
1714844|NCT00778258|3155395|Superiority or Other||Odds Ratio, log|0.77||||0.58|2-Sided|95.0|0.31|1.93|||Regression, Logistic||||
1714845|NCT00778102|3155400|Superiority or Other||Difference in Response Rate (CR or PR)|18.9||||0.0612|2-Sided|95.0|-2.1|40.0|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with confirmed best overall response of CR or PR.|
1714846|NCT00778102|3155407|Superiority or Other||Difference in Response Rate|-4.8||||0.7817|2-Sided|95.0|-43.0|33.5|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with complete or major histopathological response.|
1714847|NCT00778102|3155410|Superiority or Other||Difference in Resection Rate|12.3||||0.2707|2-Sided|95.0|-11.0|35.5|||Chi-squared||Confidence interval calculated for difference based on Hauck-Anderson method.|Difference between groups in the collective percentage of participants with R0, R1, or R2.|
1714848|NCT00777803|3155433|Non-Inferiority or Equivalence|A two-sided 95% Newcombe confidence interval for proportions (paired data) was applied. The lower bound of the Newcombe-Wilson confidence interval of the difference in response rates between groups was compared to the non-inferiority margin of -15%.|difference of response rates|0.7|||||2-Sided|95.0|-3.2|7.1|||||Difference of response rates = response rate in IncobotulinumtoxinA (Xeomin®/Bocouture®) - response rate in OnabotulinumtoxinA (Vistabel®)|Null Hypothesis: Response rate of IncobotulinumtoxinA (Xeomin®/Bocouture®) minus the response rate of OnabotulinumtoxinA (Vistabel®) is lower or equal -15% (non-inferiority margin).|
1714849|NCT00777608|3155445|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|1.3||0.401|2-Sided|90.0|-2.6|1.9|||ANOVA||Statistical analysis for Week 12||
1714850|NCT00777608|3155445|Superiority or Other||Mean Difference (Final Values)|0.8|Standard Error of the Mean|1.4||0.285|2-Sided|90.0|-1.5|3.1|||ANOVA||||
1714851|NCT00777608|3155445|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|1.0||0.324|2-Sided|90.0|-1.2|2.2|||ANOVA||Statistical analysis for Week 4||
1714852|NCT00777608|3155446|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.1||0.226|2-Sided|90.0|-0.2|0.09|||ANOVA||Statistical analysis for Week 12||
1714853|NCT00777608|3155446|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.09||0.143|2-Sided|90.0|-0.3|0.06|||ANOVA||Statistical analysis for Week 8||
1714854|NCT00777608|3155446|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.09||0.041|2-Sided|90.0|-0.3|-0.008|||ANOVA||Statistical analysis for Week 2||
1714855|NCT00777608|3155447|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.231|2-Sided|90.0|-0.2|0.08|||ANOVA||||
1714856|NCT00777491|3155456|Superiority||Odds Ratio (OR)|0.493||||0.3|2-Sided|95.0|0.129|1.881||Two-sided significance level of 0.05|Regression, Logistic|Univariate analysis|Reference arm = 5-FU and Cisplatin + BID Irradiation||
1714857|NCT00777491|3155459|Other|There was no formal comparison of the two treatment arms.||||||||||||||||The confidence interval of the rate was calculated by Clopper-Pearson’s exact binomial confidence intervals methods with one-sided type I error of 0.1. The study required 32 analyzable patients in each arm, which would warrant a 10% chance of observing a percentage of patients without distant metastasis by 3 years of less than 75% if the true rate was 86%. With the actual number of evaluable patients, the study instead warrants a 13-14% chance.|If the percentage of patients without distant metastasis by 3 years for either arm was greater than or equal to 75%, then it would be strongly considered as a potential arm in a subsequent phase III study, assuming treatment delivery and adverse events (AEs) were acceptable. If both arms met the criteria, then the treatment arm with less toxicity would be chosen.
1714858|NCT00777205|3155478|Superiority or Other||Slope|-0.08|||||2-Sided|95.0|-3.31|3.16|||||||
1714859|NCT00777205|3155479|Superiority or Other||Slope|-0.039|||<|0.05|2-Sided|95.0|-2.66|1.89|||Mixed Models Analysis||||
1714860|NCT00777205|3155480|Superiority or Other||Slope|0.81|||<|0.05|2-Sided|95.0|-0.93|2.55|||Mixed Models Analysis||||
1714861|NCT00777205|3155481|Superiority or Other||Slope|-0.39|||<|0.05|2-Sided|95.0|-2.03|1.24|||Mixed Models Analysis||||
1714862|NCT00777205|3155482|Superiority or Other||Slope|0.22|||<|0.05|2-Sided|95.0|-1.57|2.01|||Mixed Models Analysis||||
1715875|NCT00764478|3157483|Superiority or Other|||||||0.0005|||||||Cochran-Mantel-Haenszel|||Day 2|
1714863|NCT00777101|3155500|Non-Inferiority|Non-inferiority of neratinib vs lapatinib + capecitabine was to be concluded if the upper limit of the 95% confidence interval (CI) for the hazard ratio was 1.15 or less.|Hazard Ratio (HR)|1.19||||0.231|2-Sided|95.0|0.89|1.6|||Log Rank|The log-rank test comparing treatment groups is stratified by region.|The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by region.||
1714864|NCT00777088|3155508|Non-Inferiority or Equivalence|The rate of complete IA occlusion without major parent artery stenosis exceeds 50% with a posterior probability >0.975.|||||<|0.001|||||||Bayesian||||
1714865|NCT00777088|3155509|Non-Inferiority|The cumulative rate of ipsilateral stroke or neurologic death is not ≥ 20% at 180-day clinical follow-up and the cumulative rate of ipsilateral stroke or neurovascular death is not ≥ 25% at 5-year clinical follow-up|||||<|0.001|||||||Bayesian||||
1714866|NCT00777023|3155534|Superiority or Other||Mean Difference (Net)|-0.29|Standard Error of the Mean|0.1||0.0026|2-Sided|97.5|-0.51|-0.07||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12|
1714867|NCT00777023|3155534|Superiority or Other||Mean Difference (Net)|-0.21|Standard Error of the Mean|0.1||0.028|2-Sided|97.5|-0.43|0.0||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 12|
1714868|NCT00777023|3155535|Superiority or Other||Mean Difference (Net)|-0.28|Standard Error of the Mean|0.08||0.0003|2-Sided|97.5|-0.45|-0.11||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4|
1714869|NCT00777023|3155535|Superiority or Other||Mean Difference (Net)|-0.15|Standard Error of the Mean|0.08||0.0608|2-Sided|97.5|-0.32|-0.03||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at SDW 4|
1714870|NCT00777023|3155536|Superiority or Other||Mean Difference (Net)|-1.12|Standard Error of the Mean|0.51||0.0281|2-Sided|97.5|-2.26|0.02||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12|
1714871|NCT00777023|3155536|Superiority or Other||Mean Difference (Net)|-1.56|Standard Error of the Mean|0.51||0.0024|2-Sided|97.5|-2.72|-0.41||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 12|
1714872|NCT00777023|3155537|Superiority or Other||Mean Difference (Net)|-1.51|Standard Error of the Mean|0.52||0.004|2-Sided|97.5|-2.69|-0.33||P value for pairwise test of difference of least square mean change from baseline between G-ER 1800 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4|
1714873|NCT00777023|3155537|Superiority or Other||Mean Difference (Net)|-1.61|Standard Error of the Mean|0.53||0.0024|2-Sided|97.5|-2.8|-0.42||P value for pairwise test of difference of least square mean change from baseline between G-ER 1200 mg and placebo groups based on F test of type III analysis.|ANCOVA|||Null hypothesis: no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at SDW 4|
1714874|NCT00776984|3155542|Superiority or Other||Odds Ratio (OR)|1.68||||0.0001|2-Sided|95.0|1.28|2.21||Calculated as 2*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 48 weeks|
1714875|NCT00776984|3155542|Superiority or Other||Odds Ratio (OR)|1.32||||0.0427|2-Sided|95.0|1.01|1.73||Calculated as 2*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 24 weeks|
1714876|NCT00776984|3155543|Superiority or Other||Mean Difference (Final Values)|-0.263|Standard Error of the Mean|0.189||0.1664||95.0|-0.635|0.11||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714877|NCT00776984|3155544|Superiority or Other||Mean Difference (Final Values)|0.012|Standard Error of the Mean|0.028||0.6632||95.0|-0.043|0.067||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714878|NCT00776984|3155545|Superiority or Other||Mean Difference (Final Values)|-0.133|Standard Error of the Mean|0.069||0.0533||95.0|-0.267|0.002||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714879|NCT00776984|3155546|Superiority or Other||Mean Difference (Final Values)|-0.199|Standard Error of the Mean|0.067||0.003||95.0|-0.33|-0.068||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714880|NCT00776984|3155547|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.08||0.0803||95.0|-0.017|0.296||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714975|NCT00774397|3155855|Superiority or Other||||||<|0.0001||||||P-value based on Fisher’s exact test (2-sided)|Fisher Exact||||
1714976|NCT00774397|3155855|Superiority or Other||||||<|0.0001||||||P-value based on Fisher’s exact test (2-sided)|Fisher Exact||||
1714881|NCT00776984|3155548|Superiority or Other||Mean Difference (Final Values)|0.178|Standard Error of the Mean|0.078||0.0225||95.0|0.025|0.331||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714882|NCT00776984|3155549|Superiority or Other||Odds Ratio (OR)|0.85||||0.8129||95.0|0.29|2.46||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo||
1714883|NCT00776984|3155550|Superiority or Other||Risk Ratio (RR)|0.95|Standard Error of the Mean|0.23||0.8503||95.0|0.59|1.54||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo.||
1714884|NCT00776984|3155551|Superiority or Other||Hazard Ratio (HR)|0.84||||0.7188||95.0|0.33|2.14||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.||
1714885|NCT00776984|3155552|Superiority or Other||Odds Ratio (OR)|0.88||||0.5481||95.0|0.58|1.32||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo||
1714886|NCT00776984|3155553|Superiority or Other||Odds Ratio (OR)|0.57||||0.004||95.0|0.38|0.84||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95 percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo||
1714887|NCT00776984|3155554|Superiority or Other||Risk Ratio (RR)|0.96|Standard Error of the Mean|0.15||0.7906||95.0|0.71|1.3||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo||
1714888|NCT00776984|3155555|Superiority or Other||Risk Ratio (RR)|0.8|Standard Error of the Mean|0.11||0.1007||95.0|0.61|1.04||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo||
1714889|NCT00776984|3155556|Superiority or Other||Hazard Ratio (HR)|0.89||||0.4788||95.0|0.65|1.23||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.||
1714890|NCT00776984|3155557|Superiority or Other||Mean Difference (Final Values)|1.197|Standard Error of the Mean|0.741||0.1073||95.0|-0.261|2.655||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714891|NCT00776984|3155558|Superiority or Other||Mean Difference (Final Values)|0.137|Standard Error of the Mean|0.032|<|0.0001||95.0|0.074|0.2||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714892|NCT00776984|3155559|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.03||0.0027||95.0|0.031|0.149||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714893|NCT00776984|3155560|Superiority or Other||Mean Difference (Final Values)|32.453|Standard Error of the Mean|5.044|<|0.0001||95.0|22.532|42.374||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714894|NCT00776984|3155561|Superiority or Other||Mean Difference (Final Values)|20.654|Standard Error of the Mean|4.807|<|0.0001||95.0|11.199|30.108||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714895|NCT00776984|3155562|Superiority or Other||Mean Difference (Final Values)|0.109|Standard Error of the Mean|0.041||0.0074||95.0|0.029|0.189||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714896|NCT00776984|3155563|Superiority or Other||Mean Difference (Final Values)|0.071|Standard Error of the Mean|0.042||0.0933||95.0|-0.012|0.153||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714897|NCT00776984|3155564|Superiority or Other||Mean Difference (Final Values)|0.114|Standard Error of the Mean|0.044||0.0088||95.0|0.029|0.2||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714898|NCT00776984|3155565|Superiority or Other||Mean Difference (Final Values)|0.138|Standard Error of the Mean|0.031|<|0.0001||95.0|0.078|0.199||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714899|NCT00776984|3155566|Superiority or Other||Mean Difference (Final Values)|0.092|Standard Error of the Mean|0.03||0.0026||95.0|0.032|0.151||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714900|NCT00776984|3155567|Superiority or Other||Mean Difference (Final Values)|0.152|Standard Error of the Mean|0.033|<|0.0001||95.0|0.087|0.217||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714901|NCT00776984|3155568|Superiority or Other||Mean Difference (Final Values)|0.109|Standard Error of the Mean|0.04||0.0063||95.0|0.031|0.187||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714977|NCT00774397|3155855|Superiority or Other||||||<|0.0001||||||P-value based on Fisher’s exact test (2-sided)|Fisher Exact||||
1715876|NCT00764478|3157483|Superiority or Other|||||||0.0104|||||||Cochran-Mantel-Haenszel|||Day 2|
1714902|NCT00776984|3155569|Superiority or Other||Mean Difference (Final Values)|0.143|Standard Error of the Mean|0.03|<|0.0001||95.0|0.084|0.202||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714903|NCT00776984|3155570|Superiority or Other||Mean Difference (Final Values)|0.106|Standard Error of the Mean|0.041||0.0099||95.0|0.025|0.186||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714904|NCT00776984|3155571|Superiority or Other||Mean Difference (Final Values)|0.094|Standard Error of the Mean|0.042||0.0275||95.0|0.01|0.177||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714905|NCT00776984|3155572|Superiority or Other||Hazard Ratio (HR)|0.79||||0.0343||||||Confirmatory only if previous hypotheses for each of the 2 twin studies had been successful, significance level of alpha=0.05 (2-sided). A pre-specified interim analysis was performed. Cui et al (Biometrics,1999) was used to calculate the p-value.|Regression, Cox|Parameter estimates of Cox proportional hazard model regression regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.||
1714906|NCT00776984|3155573|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|0.03||0.0002||95.0|0.053|0.169||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714907|NCT00776984|3155574|Superiority or Other||Mean Difference (Final Values)|0.154|Standard Error of the Mean|0.032|<|0.0001||95.0|0.091|0.217||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1714908|NCT00776919|3155585|Superiority or Other||||||<|0.001||||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA||||
1714909|NCT00776919|3155585|Superiority or Other||||||<|0.032||||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA||||
1714910|NCT00776919|3155585|Superiority or Other||||||<|0.001||||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA||||
1714911|NCT00776919|3155586|Superiority or Other||||||<|0.001||||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA||||
1714912|NCT00776919|3155586|Superiority or Other||||||<|0.102||||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA||||
1714913|NCT00776919|3155586|Superiority or Other||||||<|0.001||||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA||||
1714914|NCT00776919|3155587|Superiority or Other||||||<|0.001||||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA||||
1714915|NCT00776919|3155587|Superiority or Other||||||<|0.015||||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA||||
1714916|NCT00776919|3155587|Superiority or Other||||||<|0.001||||||Based on an analysis of covariance (ANCOVA) with factors of treatment, center, and interaction of treatment-center. If the treatment-center interaction was not significant at the 0.1 level, this interaction was excluded from the ANCOVA model.|ANCOVA||||
1714917|NCT00776919|3155588|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1714918|NCT00776919|3155588|Superiority or Other||||||<|0.016|||||||Cochran-Mantel-Haenszel||||
1714919|NCT00776919|3155588|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1714920|NCT00776789|3155589|Superiority or Other||Odds Ratio (OR)|2.5||||0.001||95.0|1.6|6.3|||Wilcoxon (Mann-Whitney)||||
1714921|NCT00776789|3155590|Superiority or Other||Odds Ratio (OR)|2.5||||0||95.0|1.4|4.3|||Wilcoxon (Mann-Whitney)|||Exclusive breast feeding at 48 hours was 95% (19 out of 20 partcipants were exclusively breast feeding)in the skin-to-skin contact group vs. 38.1% in the control group|
1714922|NCT00776789|3155591|Superiority or Other|||||||0.4|||||||Wilcoxon (Mann-Whitney)||||
1714923|NCT00775983|3155623|Non-Inferiority or Equivalence|Power: We assumed a standard deviation of five minutes based on historical clinic data for surgical abortions during this gestational duration range, a non-inferiority margin of five minutes, and a 10% potential attrition rate to power the study for a non-inferiority hypothesis. Thirty participants in each arm gave us 95% power to conclude non-inferiority of same day Dilapan-S compared to overnight laminaria with respect to procedure time of surgical abortions between 14-18 weeks gestation.|Mean Difference (Final Values)|2.1|||||2-Sided|97.5|-0.3|4.5||||||Null Hypothesis: A surgical abortion performed between 14-18 weeks gestation performed after the cervix has been prepared with same-day Dilapan-S is inferior with respect to procedure time, which is specifically outside a five minute margin of non-inferiority, when compared to procedures during the same gestational duration range performed after the cervix has been prepared overnight with laminaria.|
1714925|NCT00775684|3155638|Superiority||||||>|0.1|||||||t-test, 1 sided|||To determine if exenatide or sitagliptin induced significant changes from baseline, the change for each measure (Δ = final - baseline) for each group was compared with the change in the glimepiride group using independent Student t tests|
1714926|NCT00775684|3155639|Superiority||||||>|0.1|||||||t-test, 1 sided|||Within group changes over 6 months (delta= final - baseline) were compared.|
1714927|NCT00775684|3155640|Superiority||||||<|0.05|||||||t-test, 2 sided|||Repeated measure (baseline and 6 months)|
1714928|NCT00775684|3155640|Superiority||||||=|0|||||||t-test, 2 sided|||Student t test|
1714929|NCT00775658|3155643|Superiority|Sample size determined that 18 participants would provide 80% power to detect a 20% difference with a significance level of 0.05.||||||0.09|||||||Wilcoxon (Mann-Whitney)||||
1714930|NCT00775658|3155644|Superiority or Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||Before the study, we determined that a sample size of 18 would be adequate to detect a 20% difference in wheal and flare areas with 80% power and a significance level of 0.05.|
1714931|NCT00775645|3155649|Superiority|||||||0.46|||||||Regression, Linear|Adjusted for randomization stratification factors.|||
1714932|NCT00775645|3155650|Superiority or Other||Mean Difference (Final Values)|1.3||||0.2|2-Sided|95.0|-0.7|3.3|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.|||
1714933|NCT00775645|3155651|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.92|2-Sided|95.0|-3.0|2.7|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.|||
1714934|NCT00775645|3155652|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.17|2-Sided|95.0|-2.2|0.4|||Regression, Linear|Linear regression model adjusted for baseline score, taxane regiment, and age.|||
1714935|NCT00775463|3155670|Superiority or Other||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.1|2-Sided|95.0|-1.0|0.0||P value for Total Pain Rating Index Score|Wilcoxon (Mann-Whitney)|||P value for Total Pain Rating Index Score|
1714936|NCT00775463|3155670|Superiority or Other||Hodges-Lehmann Estimate of Treatment Ef|-0.6||||0.18|2-Sided|95.0|-1.6|0.3||P value for Pain VAS|Wilcoxon (Mann-Whitney)|||P value for Pain VAS|
1714937|NCT00775463|3155670|Superiority or Other||Hodges-Lehmann Estimate of Treatment Eff|-1.0||||0.54|2-Sided|95.0|-3.0|2.0||P value for Total Pain Rating Index Score|Wilcoxon (Mann-Whitney)|||P value for Total Pain Rating Index Score|
1714938|NCT00775463|3155671|Superiority or Other||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.68|2-Sided|95.0|0.0|1.0|||Wilcoxon (Mann-Whitney)|||he difference between treatment groups for the change from Baseline and at Week 20 in the mRSS was tested using the Wilcoxon rank-sum test.|
1714939|NCT00775463|3155673|Superiority or Other||Hodges-Lehmann Estimate of Treatment Eff|-1.0||||0.47|2-Sided|95.0|-4.0|2.0||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The difference between treatment groups for the change from Baseline in CHFS Score were tested using the Wilcoxon rank-sum test.|
1714940|NCT00775463|3155674|Superiority or Other||Hodges-Lehmann Estimate of Treatment Eff|-9.3||||0.04|2-Sided|95.0|-18.0|0.0||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The VAS-global assessments were recorded in centimeters, with possible values ranging from 0.0 to 15.0. The recorded value was divided by 15, then multiplied by 100 to convert it to the VAS-Global scale, with values ranging from 0 (no disease activity) to 100 (very severe disease). The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.|
1714941|NCT00775463|3155675|Superiority or Other||Hodges-Lehmann Estimate of Treatment Eff|-9.3||||0.12|2-Sided|95.0|-21.3|2.7||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The VAS-global assessments were recorded in centimeters, with possible values ranging from 0.0 to 15.0. The recorded value was divided by 15, then multiplied by 100 to convert it to the VAS-Global scale, with values ranging from 0 (no disease activity) to 100 (very severe disease). The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.|
1714942|NCT00775463|3155676|Superiority or Other||Hodges-Lehmann Estimate of Treatment Eff|-0.4||||0.31|2-Sided|95.0|-1.4|0.4||Analyses of secondary endpoints were descriptive in nature, no adjustments for multiplicity were made. P-values are for the purpose of describing the random imbalance between treatment groups and not to test formal hypotheses.|Wilcoxon (Mann-Whitney)|||The difference between treatment groups for the change from Baseline was tested using the Wilcoxon rank-sum test.|
1714943|NCT00775463|3155677|Superiority or Other||Hodges-Lehmann Estimate of Treatment Eff|0.0||||0.2|2-Sided|95.0|-1.0|0.0|||Cochran-Mantel-Haenszel|||A Cochran-Mantel Haenszel mean score test was used on the standardized reverse mid-ranks (overall reverse ranks divided by the number of ranks +1, or modified ridit scores; largely negative changes had ranks near 1 and largely positive changes had ranks near 0)of the residuals from an ordinary least squares regression with change in net ulcer burden at Week 20 as a linear function of Baseline PDEI or prostacyclin use (binary variable:Yes/No) and net ulcer burden at Baseline(continuous variable).|
1714944|NCT00775203|3155749|Superiority or Other|||||||0.0119|||||||ANCOVA|ANCOVA with treatment and study center as categorical factors and HAMD-17 baseline as covariate.||The primary null hypothesis for the HAMD-17 total score is that there is no difference between the Trazodone Contramid® OAD group and the placebo group at Week 8. A sample size of 133 in each group will have 90% power to detect a difference in the absolute mean Hamilton Rating Scale for Depression (HAMD-17) change from baseline of 3.0 units assuming that the common standard deviation is 7.5 using a two-group t-test with a 0.05 two-sided significance level.|
1714945|NCT00775021|3155769|Non-Inferiority or Equivalence|Margin = -0.5|Mean Difference (Final Values)|0.2489|Standard Error of the Mean|0.168|||2-Sided|98.7|-0.1301|0.2489|||||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etaflicon A contact lenses have equal to or higher ratings of ease of handling than nelfilcon A contact lenses.|
1714978|NCT00774397|3155855|Superiority or Other||||||<|0.0001||||||P-value based on Fisher’s exact test (2-sided)|Fisher Exact||||
1714946|NCT00775021|3155770|Non-Inferiority or Equivalence|Margin = -0.5|Mean Difference (Final Values)|-0.1088|Standard Error of the Mean|0.1741|||2-Sided|98.7|-0.5016|-0.1088|||||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etafilcon A contact lenses will have equal or higher ratings of initial comfort than nelfilcon A contact lenses.|
1714947|NCT00775021|3155771|Non-Inferiority or Equivalence|Margin = -0.5|Mean Difference (Final Values)|0.4001|Standard Error of the Mean|0.1799|||2-Sided|98.7|-0.0055|0.4001|||||The mean difference is calculated as etafilcon A minus nelfilcon A.|The alternative hypothesis is that etafilcon A contact lenses have equal to or higher comfort ratings at the end of the day than nelfilcon A.|
1714948|NCT00775021|3155772|Superiority or Other||Mean Difference (Final Values)|-0.108|Standard Error of the Mean|0.07768|||2-Sided|98.7|-0.108|0.06501|||||Mean difference calculated etafilcon A minus nelfilcon A. Analysis adjusted for lens type, period, lens by period interaction, gender, lens by gender interaction as fixed effects, subject nested within site and eye within subject as random effect.|The alternative hypothesis is that eyes that wore etafilcon A contact lenses will have less inferior region corneal staining than eyes that wore nelfilcon A contact lenses.|
1714949|NCT00775021|3155773|Non-Inferiority or Equivalence|Margin = -0.5|Mean Difference (Final Values)|0.2334|Standard Error of the Mean|0.1618|||2-Sided|95.0|-0.03501|0.2334|||||The mean difference is calculated as etafilconA minus nelfilcon A. Analysis is adjusted for lens type, period, lens type by period interaction, gender, lens type by gender interaction as fixed effects, subject nested within site as random effect.|The alternative hypothesis is that etafilcon A contact lenses will have equal to ro higher ratings of overall comfort than nelfilcon A contact lenses.|
1714950|NCT00774930|3155790|Superiority or Other|||||||0.2544|||||||ANCOVA|ANCOVA included treatment group and 2 stratification variables at randomisation as factors and average frequency of diarrhoea per day during Screening|||
1714951|NCT00774930|3155791|Superiority or Other|||||||0.0165|||||||ANCOVA|This analysis does not include any imputation for the early roll over subjects|||
1714952|NCT00774852|3155792|Superiority or Other|||||||0.99|||||||Chi-squared|Pearson’s||Comparison of groups for Tetanus Toxoid vaccines|
1714953|NCT00774852|3155792|Superiority or Other|||||||0.43|||||||Chi-squared|Pearson’s||Comparison of groups for Pneumococcal vaccines|
1714954|NCT00774852|3155793|Superiority or Other|||||||0.74||||||P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.|ANCOVA||||
1714955|NCT00774852|3155793|Superiority or Other|||||||0.79||||||P-value compares actual values between experimental and control groups at Week 52 and is derived from two-sided t-test from and ANCOVA model that adjusts for baseline values.|ANCOVA||||
1714956|NCT00774852|3155798|Superiority or Other||||||>|0.99|||||||Chi-squared|Pearson’s||Comparison of groups with at least one non-renal flare|
1714957|NCT00774852|3155798|Superiority or Other||||||>|0.99|||||||Chi-squared|Pearson’s||Comparison of groups with at least one non-renal flare|
1714958|NCT00774852|3155798|Superiority or Other||||||>|0.61|||||||Chi-squared|Pearson’s||Comparison of groups with renal flare|
1714959|NCT00774852|3155798|Superiority or Other||||||>|0.23|||||||Chi-squared|Pearson’s||Comparison of groups with renal flare|
1714960|NCT00774852|3155800|Superiority or Other||||||>|0.99|||||||Chi-squared|Two-sided Pearson’s chi-squared test||Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.|
1714961|NCT00774852|3155801|Superiority or Other||||||>|0.99|||||||Chi-squared|Two-sided Pearson’s chi-squared test||Comparison of Participants across groups who had negative anti-dsDNA at Week 104. Baseline is defined as the last measurement taken on or prior to the first day of dosing. Analysis is performed on participants with available data.|
1714962|NCT00774852|3155806|Superiority or Other|||||||0.54|||||||Chi-squared|Two-sided Pearson’s chi-square test|||
1714963|NCT00774852|3155807|Superiority or Other|||||||0.72|||||||Chi-squared|Two-sided Pearson’s chi-square test|||
1714964|NCT00774852|3155807|Superiority or Other|||||||0.54|||||||Chi-squared|Two-sided Pearson’s chi-square test|||
1714965|NCT00774852|3155808|Superiority or Other|||||||0.99|||||||Chi-squared|Two-sided Pearson's chi-square test|||
1714966|NCT00774852|3155809|Superiority or Other|||||||0.85|||||||Chi-squared|Two-sided Pearson's chi-square test|||
1714967|NCT00774800|3155811|Superiority or Other||Least Squares Means Difference|-62.46||||0.0018|||||||ANOVA|Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.|
1714968|NCT00774800|3155811|Superiority or Other||Least Squares Means Difference|-18.33|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.|
1714969|NCT00774800|3155812|Superiority or Other||Geometric Least Squares Means Ratio|1.66|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.|
1714970|NCT00774800|3155812|Superiority or Other||Geometric Least Squares Means Ratio|1.35|||<|0.0057||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.|
1714971|NCT00774800|3155813|Superiority or Other||Geometric Least Squares Means Ratio|3.06|||<|0.0001||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.|
1714972|NCT00774800|3155813|Superiority or Other||Geometric Least Squares Means Ratio|1.54|||<|0.0011||||||Statistical testing was considered exploratory, with no adjustment for inflation of Type 1 error due to multiplicity of testing.|ANOVA|||Due to the exploratory nature of this study, the sample size is not based on a formal calculation.|
1714973|NCT00774579|3155823|Superiority|||||||0.1|||||||t-test, 2 sided||||
1714974|NCT00774579|3155824|Superiority|||||||0.6|||||||t-test, 2 sided||||
1714981|NCT00773734|3155996|Superiority or Other (legacy)||Difference in LS Means|0.1||||0.9528|2-Sided|95.0|-2.2|2.3|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.|||
1714982|NCT00773734|3155996|Superiority or Other (legacy)||Difference in LS Means|1.3||||0.2424|2-Sided|95.0|-0.9|3.6|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.|||
1714983|NCT00773734|3155996|Superiority or Other (legacy)||Difference in LS Means|0.6||||0.6097|2-Sided|95.0|-1.6|2.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.|||
1714984|NCT00773734|3155997|Superiority or Other (legacy)||Difference in LS Means|3.6||||0.0045|2-Sided|95.0|1.1|6.1|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.|||
1714985|NCT00773734|3155997|Superiority or Other (legacy)||Difference in LS Means|3.5||||0.0068|2-Sided|95.0|1.0|6.0|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.|||
1714986|NCT00773734|3155997|Superiority or Other (legacy)||Difference in LS Means|3.3||||0.0078|2-Sided|95.0|0.9|5.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.|||
1714987|NCT00773734|3155999|Superiority or Other (legacy)||Difference in LS Means|-2.6||||0.0047|2-Sided|95.0|-4.3|-0.8|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.|||
1714988|NCT00773734|3155999|Superiority or Other (legacy)||Difference in LS Means|-4.1|||<|0.0001|2-Sided|95.0|-5.9|-2.3|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.|||
1714989|NCT00773734|3155999|Superiority or Other (legacy)||Difference in LS Means|-1.3|||<|0.1322|2-Sided|95.0|-3.1|0.4|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate.|||
1714990|NCT00773734|3156001|Superiority or Other (legacy)||LS Mean Difference|-42.4|||<|0.0001|2-Sided|95.0|-55.2|-29.5||Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate|ANCOVA||||
1714991|NCT00773734|3156001|Superiority or Other (legacy)||LS Mean Difference|-29.9|||<|0.0001|2-Sided|95.0|-42.9|-17.0|||ANCOVA|based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate|||
1714992|NCT00773734|3156001|Superiority or Other (legacy)||LS Mean Difference|-20.2|||<|0.002|2-Sided|95.0|-33.0|-7.5|||ANCOVA|Based on an analysis of covariance model with treatment group as a factor and the baseline value as a covariate|||
1714993|NCT00773734|3156005|Superiority or Other (legacy)||Risk Difference (RD)|21.1||||0.0011|2-Sided|95.0|8.8|33.4|||Chi-squared||||
1714994|NCT00773734|3156005|Superiority or Other (legacy)||Risk Difference (RD)|12.4||||0.0402|2-Sided|95.0|0.6|24.1|||Chi-squared||||
1714995|NCT00773734|3156005|Superiority or Other (legacy)||Risk Difference (RD)|-2.2||||0.6541|2-Sided|95.0|-11.7|7.3|||Chi-squared||||
1714996|NCT00773734|3156007|Superiority or Other (legacy)||LS Mean Difference|-32.9|||<|0.0001|2-Sided|95.0|-44.0|-21.7|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.|||
1714997|NCT00773734|3156007|Superiority or Other (legacy)||LS Mean Difference|-25.1|||<|0.0001|2-Sided|95.0|-36.4|-13.9|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.|||
1714998|NCT00773734|3156007|Superiority or Other (legacy)||Least Square Mean Difference|-13.7|||<|0.0156|2-Sided|95.0|-24.8|-2.6|||ANCOVA|Analysis of covariance model with treatment group as a factor and the baseline value as a covariate.|||
1714999|NCT00773734|3156012|Superiority or Other (legacy)||Risk Difference (RD)|10.2||||0.0051|2-Sided|95.0|3.2|17.2|||Chi-squared||||
1715000|NCT00773734|3156012|Superiority or Other (legacy)||Risk Difference (RD)|8.1||||0.0158|2-Sided|95.0|1.6|14.5|||Chi-squared||||
1715001|NCT00773734|3156012|Superiority or Other (legacy)||Risk Difference (RD)|3.4||||0.1776|2-Sided|95.0|-1.5|8.2|||Chi-squared||||
1715002|NCT00773734|3156014|Superiority or Other (legacy)||Risk Difference (RD)|35.2|||<|0.0001|2-Sided|95.0|21.6|48.9|||Chi-squared||||
1715003|NCT00773734|3156014|Superiority or Other (legacy)||Risk Difference (RD)|22.1|||<|0.0023|2-Sided|95.0|8.3|36.0|||Chi-squared||||
1715004|NCT00773734|3156014|Superiority or Other (legacy)||Risk Difference (RD)|13.2|||<|0.059|2-Sided|95.0|-0.4|26.8|||Chi-squared||||
1715005|NCT00773734|3156016|Superiority or Other (legacy)||Risk Difference (RD)|35.2|||<|0.0001|2-Sided|95.0|23.9|46.6|||Chi-squared||||
1715006|NCT00773734|3156016|Superiority or Other (legacy)||Risk Difference (RD)|23.1|||<|0.0001|2-Sided|95.0|12.4|33.7|||Chi-squared||||
1715007|NCT00773734|3156016|Superiority or Other (legacy)||Risk Difference (RD)|5.6|||<|0.1846|2-Sided|95.0|-2.6|13.7|||Chi-squared||||
1715008|NCT00773513|3156021|Non-Inferiority|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.91||||0.0048|2-Sided|95.0|0.74|1.12|||Regression, Cox||||
1715009|NCT00773513|3156022|Non-Inferiority|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.94||||0.0459|2-Sided|95.0|0.7|1.25|||Regression, Cox||||
1715010|NCT00773513|3156023|Non-Inferiority|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|0.95||||0.0219|2-Sided|95.0|0.76|1.19|||Regression, Cox||||
1715011|NCT00773513|3156024|Non-Inferiority|The critical alpha level for the non-inferiority test was 0.025|Hazard Ratio (HR)|1.06||||0.0166|2-Sided|95.0|0.94|1.19|||Regression, Cox||||
1715012|NCT00773513|3156025|Non-Inferiority|The critical alpha level for the non-inferiority test was 0.025.|Hazard Ratio (HR)|1.03||||0.0039|2-Sided|95.0|0.93|1.15|||Regression, Cox||The pre-specified upper non-inferiority limit was 95% CI <1.20.||
1715013|NCT00773461|3156033|Superiority or Other||Mean Difference (Final Values)|-0.42|||<|0.0001|2-Sided|95.0|-0.56|-0.28|||ANCOVA||||
1715014|NCT00773461|3156034|Superiority or Other||Mean Difference (Final Values)|12.956|||<|0.0001|2-Sided|95.0|9.125|16.786|||ANCOVA||||
1715015|NCT00773461|3156035|Superiority or Other||Mean Difference (Final Values)|-68.3||||0.0599|2-Sided|95.0|-139.5|2.9|||ANCOVA||||
1715016|NCT00773461|3156036|Superiority or Other||Mean Difference (Final Values)|3.8||||0.0003|2-Sided|95.0|1.8|5.9|||ANCOVA||||
1715017|NCT00773461|3156038|Superiority or Other||Mean Difference (Final Values)|-39.2|||<|0.0001|2-Sided|95.0|-44.7|-33.7|||ANCOVA||||
1715018|NCT00773461|3156039|Superiority or Other||Mean Difference (Final Values)|-1.7384|||<|0.0001|2-Sided|95.0|-2.1464|-1.3303|||ANCOVA||||
1715019|NCT00773461|3156040|Superiority or Other||Mean Difference (Final Values)|-19.0|||<|0.0001|2-Sided|95.0|-25.2|-12.7|||ANCOVA||||
1715020|NCT00773461|3156041|Superiority or Other||Mean Difference (Final Values)|-19.3|||<|0.0001|2-Sided|95.0|-24.5|-14.0|||ANCOVA||||
1715021|NCT00773461|3156042|Superiority or Other||Mean Difference (Final Values)|-19.1|||<|0.0001|2-Sided|95.0|-25.3|-12.9|||ANCOVA||||
1715022|NCT00773461|3156043|Superiority or Other||Mean Difference (Final Values)|-8.7|||<|0.0001|2-Sided|95.0|-11.3|-6.1||p value was calculated using the difference between core set values of the two arms.|ANCOVA|||Placebo + DMARDs Vs Tocilizumab + DMARDs analysis for Tender Joint Count|
1715023|NCT00773461|3156043|Superiority or Other||Mean Difference (Final Values)|-4.7|||<|0.0001|2-Sided|95.0|-6.6|-2.8||p value was calculated using the difference between core set values of the two arms.|ANCOVA|||Placebo + DMARDs Vs Tocilizumab + DMARDs analysis for Swollen Joint Count|
1715024|NCT00773461|3156045|Superiority or Other|||||||0.0345||||||Comparison of ACR 70 responders in placebo and Tocilizumab groups|Cochran-Mantel-Haenszel||||
1715025|NCT00773461|3156045|Superiority or Other||||||<|0.0001||||||Comparison of ACR 50 responders in placebo and Tocilizumab groups|Cochran-Mantel-Haenszel||||
1715026|NCT00773461|3156046|Superiority or Other||||||<|0.0001||||||ITT Population (Sensitivity)|Cochran-Mantel-Haenszel||||
1715027|NCT00773461|3156046|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1715028|NCT00773370|3156063|Superiority or Other||Slope|15.193|Standard Deviation|7.553||0.051|2-Sided|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA||||
1715029|NCT00773370|3156063|Superiority or Other||Slope|15.49|Standard Deviation|6.19||0.02|2-Sided|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA||||
1715030|NCT00773370|3156063|Superiority or Other||Slope|0.296|Standard Deviation|9.77||0.98|2-Sided||||||ANOVA|||Random effects ANOVA with random intercept and random slope was used to compare the time course of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|
1715031|NCT00773370|3156064|Superiority or Other||Slope|0.031|Standard Deviation|0.057||0.59|2-Sided|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time|
1715032|NCT00773370|3156064|Superiority or Other||Slope|0.033|Standard Deviation|0.054||0.54|2-Sided|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time|
1715033|NCT00773370|3156064|Superiority or Other||Difference between slopes|0.002|Standard Deviation|0.078||0.98|2-Sided|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA||||
1715034|NCT00773370|3156065|Superiority or Other||Slope|0.029|Standard Deviation|0.187||0.88|2-Sided|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time|
1715035|NCT00773370|3156065|Superiority or Other||Slope|0.215|Standard Deviation|0.175||0.225|2-Sided|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time|
1715036|NCT00773370|3156065|Superiority or Other||Difference between slopes|0.186|Standard Deviation|0.256||0.47|2-Sided|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA||||
1715037|NCT00773370|3156066|Superiority or Other||Slope|6.52|Standard Deviation|5.13||0.218|2-Sided|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time|
1715038|NCT00773370|3156066|Superiority or Other||Slope|14.95|Standard Deviation|4.92|<|0.004|2-Sided|||||Random effects ANOVA, random intercept, random slope estimating within group change (slope) over time|ANOVA|||Within group change over time|
1715039|NCT00773370|3156066|Superiority or Other||difference between slopes|8.43|Standard Deviation|7.17|<|0.25|2-Sided|||||Random effects ANOVA with random intercept and random slope compared the time course (slopes) of change in our outcome measures across three time points: baseline, three, and six-months in our two experimental groups--APA-stroke and Sittercise.|ANOVA||||
1715040|NCT00773279|3156074|Non-Inferiority or Equivalence|"A two-sided 95 % Confidence Interval (CI) for the treatment difference, PDS290 minus FlexPen, in HbA1c after 12 weeks of treatment. PDS290 was to be declared non-inferior to FlexPen® if the upper limit of that CI would be less than the non-inferiority margin 0.40 % (absolute)."|Mean Difference (Final Values)|-0.047|Standard Error of the Mean|0.04||||95.0|-0.127|0.032||||||The null hypothesis is that PDS290 be not non-inferior to FlexPen® with respect to HbA1c after 12 weeks of treatment; non-inferiority margin is 0.4 % (absolute).|
1715041|NCT00773175|3156081|Superiority|||||||0.0007||||||CMH test controlling for center|Cochran-Mantel-Haenszel||||
1715042|NCT00773175|3156082|Superiority|||||||0.0247|||||||Wilcoxon (Mann-Whitney)||||
1715043|NCT00773175|3156088|Superiority|||||||0.0275||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 6|||
1715044|NCT00773175|3156088|Superiority|||||||0.0852||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 5|||
1715045|NCT00773175|3156088|Superiority|||||||0.1302||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 4|||
1715046|NCT00773175|3156088|Superiority||||||<|0.0001||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 2|||
1715047|NCT00773175|3156088|Superiority||||||<|0.2012||||||CMH test controlling for Center|Cochran-Mantel-Haenszel|Question 1|||
1715048|NCT00773175|3156089|Superiority||||||<|0.0001||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Degree of difficulty|||
1715049|NCT00773175|3156089|Superiority||||||<|0.0033||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Effectiveness|||
1715050|NCT00773175|3156090|Superiority|||||||0.2323||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 4|||
1715051|NCT00773175|3156090|Superiority|||||||0.6861||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 3|||
1715052|NCT00773175|3156090|Superiority|||||||0.0004||||||CMH test controlling for center|Cochran-Mantel-Haenszel|Question 2|||
1715053|NCT00773175|3156090|Superiority|||||||0.0685||||||Cochran-Mantel-Haenszel (CMH) test controlling for center|Cochran-Mantel-Haenszel|Question 1|||
1715054|NCT00773175|3156092|Superiority||Mean Difference (Net)|-1.0||||0.6208|2-Sided|95.0|-4.8|2.9|||ANOVA|From ANOVA model with center and treatment as factors|Treatment difference = SC minus IV||
1715055|NCT00773175|3156093|Superiority||Mean Difference (Final Values)|-0.4||||0.0658|2-Sided|95.0|-0.9|0.0|||ANOVA|From Analysis of Variance (ANOVA) model with center and treatment as factors.|Treatment difference = SC minus IV.||
1715056|NCT00773175|3156094|Superiority||Mean Difference (Final Values)|0.2|||||2-Sided|95.0|0.1|0.3|||||Treatment difference = SC minus IV||
1715057|NCT00773175|3156105|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-1.3|||||2-Sided|95.0|-3.4|0.8|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only||
1715058|NCT00773175|3156105|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-0.4|||||2-Sided|95.0|-2.8|1.9|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay||
1715059|NCT00773175|3156106|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|2.2|||||2-Sided|95.0|-0.2|4.7|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only||
1715060|NCT00773175|3156106|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|2.9|||||2-Sided|95.0|0.3|5.5|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay||
1715061|NCT00773175|3156108|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-40.2|||||2-Sided|95.0|-77.3|-3.1|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only||
1715062|NCT00773175|3156108|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-30.1|||||2-Sided|95.0|-69.5|9.4|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay||
1715063|NCT00773175|3156109|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-40.2|||||2-Sided|95.0|-77.3|-3.1|||||Treatment difference: subcutaneous minus intravenous; Emergency department stay only||
1715064|NCT00773175|3156109|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-30.1|||||2-Sided|95.0|-69.5|9.4|||||Treatment difference: subcutaneous minus intravenous; Emergency department plus hospital stay||
1715065|NCT00773175|3156113|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|24.6||||0.0314|2-Sided|95.0|-54.0|103.2||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous||
1715066|NCT00773175|3156113|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-67.0||||0.5035|2-Sided|95.0|-220.6|86.7||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous||
1715067|NCT00773175|3156115|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-58.6||||0.5469|2-Sided|95.0|-137.5|20.3||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous||
1715068|NCT00773175|3156115|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-174.7||||0.8915|2-Sided|95.0|-340.3|-9.1||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous||
1715069|NCT00773175|3156116|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|24.0||||0.0325|2-Sided|95.0|-54.6|102.7||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department stay only|Treatment difference: subcutaneous minus intravenous||
1715070|NCT00773175|3156116|Non-Inferiority|Subcutaneous administration would not be deemed as inferior if the volume infused subcutaneous is ≥85% of the volume infused intravenously.|Mean Difference (Final Values)|-67.5||||0.5064|2-Sided|95.0|-221.2|86.2||P-value for the test of the null hypothesis that the volume delivered via a hylenex-facilitated subcutaneous infusion was ≤85% of the volume delivered intravenously.|ANOVA|Emergency department plus hospital stay|Treatment difference: subcutaneous minus intravenous||
1715071|NCT00772967|3156121|Superiority or Other||Mean Difference (Final Values)|-1.07||||0.007||90.0|-1.77|-0.37||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk|||
1715072|NCT00772967|3156121|Superiority or Other||Mean Difference (Final Values)|-0.875||||0.019||90.0|-1.56|-0.19||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk|||
1715073|NCT00772967|3156122|Superiority or Other||Mean Difference (Final Values)|-1.15||||0.003||90.0|-1.81|-0.49||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk|||
1715074|NCT00772967|3156122|Superiority or Other||Mean Difference (Final Values)|-0.658||||0.052||90.0|-1.32|0.01||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk|||
1715075|NCT00772967|3156123|Superiority or Other||Mean Difference (Final Values)|-1.03||||0.001||90.0|-1.54|-0.53||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk|||
1715076|NCT00772967|3156123|Superiority or Other||Mean Difference (Final Values)|-0.518||||0.048||90.0|-1.03|-0.01||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk|||
1715077|NCT00772967|3156124|Superiority or Other||Mean Difference (Final Values)|-0.804||||0.043||90.0|-1.57|-0.04||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk|||
1715078|NCT00772967|3156124|Superiority or Other||Mean Difference (Final Values)|-0.611||||0.089||90.0|-1.36|0.14||1-sided, alpha = 0.05|ANCOVA|Baseline measurement included as covariate: Time-weighted average pain intensity during pretreatment walk|||
1715079|NCT00772941|3156129|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The risk factor tested was antipsychotics as a concomitant drug. The null hypothesis is that there is no difference between Varenicline with and without antipsychotics as a concomitant drug in the efficacy of Varenicline."|
1715080|NCT00772941|3156130|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The risk factor tested was prolonged administration after 12 weeks. The null hypothesis is that there is no difference between administration prolonged after 12 weeks and administration not prolonged after 12 weeks in the efficacy of Varenicline."|
1715081|NCT00772941|3156131|Superiority or Other||||||<|0.001|||||||Cochran-Armitage|||"The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no linear trend in the efficacy of Varenicline across increasing levels of tobacco consumption per day."|
1715082|NCT00772941|3156131|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Tobacco consumption per day. The null hypothesis is that there is no association between Tobacco consumption per day and the efficacy of Varenicline."|
1715083|NCT00772941|3156132|Superiority or Other||||||<|0.001|||||||Cochran-Armitage|||"The risk factor tested was Weight at Baseline. The null hypothesis is that there is no linear trend in the frequency of Treatment Related Adverse Events across increasing levels of Weight at Baseline."|
1715084|NCT00772941|3156132|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Weight at Baseline. The null hypothesis is that there is no association between Weight at Baseline and the frequency of Treatment Related Adverse Events."|
1715085|NCT00772941|3156133|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The risk factor tested was concomitant therapies. The null hypothesis is that there is no difference between Varenicline with and without concomitant therapies in the frequency of Treatment Related Adverse Events."|
1715086|NCT00772941|3156134|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The risk factor tested was concomitant drugs. The null hypothesis is that there is no difference between Varenicline with and without concomitant drugs in the frequency of Treatment Related Adverse Events."|
1715087|NCT00772941|3156135|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Chronic obstructive pulmonary disease as a complication. The null hypothesis is that there is no difference between Varenicline with and without Chronic obstructive pulmonary disease as a complication in the frequency of Treatment Related Adverse Events."|
1715088|NCT00772941|3156136|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Age. The null hypothesis is that there is no difference between <65 years and >=65 years in the frequency of Treatment Related Adverse Events."|
1715089|NCT00772941|3156137|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of Treatment Related Adverse Events."|
1715090|NCT00772603|3156175|Superiority or Other||||||=|0|||||||Fisher Exact|||Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.|
1715091|NCT00772603|3156175|Superiority or Other||||||=|0|||||||Fisher Exact|||Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Maintenance Period were made by means of Fisher's exact test for the ITT population.|
1715092|NCT00772603|3156176|Superiority or Other||||||=|0|||||||Fisher Exact|||Pairwise comparisons of OXC XR 1200mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher's exact test for the ITT population.|
1715093|NCT00772603|3156176|Superiority or Other||||||=|0|||||||Fisher Exact|||Pairwise comparisons of OXC XR 2400mg/day vs. placebo seizure-free rates during the Treatment Phase were made by means of Fisher’s exact test for the ITT population.|
1715094|NCT00772603|3156177|Superiority or Other||Odds Ratio (OR)|1.67|||=|0||95.0|0.95|2.937|||Regression, Logistic|||The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.|
1715095|NCT00772603|3156177|Superiority or Other||Odds Ratio (OR)|1.983|||=|0|2-Sided|95.0|1.126|3.494|||Regression, Logistic|||The treatment response was analyzed using a logistic regression model with treatment group as a factor and country (or cluster), age, sex, and baseline seizure frequency per 28 days as explanatory variables.|
1715115|NCT00772538|3156199|Superiority or Other||Risk Ratio (RR)|0.71|Standard Error of the Mean|0.09||0.0102||95.0|0.55|0.92||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo||
1715137|NCT00772031|3156256|Superiority or Other||Odds Ratio (OR)|1.44|||||2-Sided|95.0|0.75|2.78|||||||
1715877|NCT00764478|3157484|Superiority or Other|||||||0.003|||||||Cochran-Mantel-Haenszel|||Day 21|
1715096|NCT00772603|3156178|Superiority or Other||Median Difference (Net)|-3.3|||=|0|2-Sided|95.0|-16.2|9.7||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.|
1715097|NCT00772603|3156178|Superiority or Other||Median Difference (Net)|-33.0|||=|0|2-Sided|95.0|-33.0|-6.3||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(M) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.|
1715098|NCT00772603|3156179|Superiority or Other||Median Difference (Net)|-10.3|||=|0|2-Sided|95.0|-22.3|1.2||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 24% to 32% between placebo and 1200mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.|
1715099|NCT00772603|3156179|Superiority or Other||Median Difference (Net)|-18.3|||=|0|2-Sided|95.0|-30.4|-5.8||P values reported are not adjusted for multiple comparisons. To preserve the overall Type I error-rate at 0.050, a step-up Hochberg procedure was used for the pair-wise comparisons.|Wilcoxon (Mann-Whitney)|||A Wilcoxon rank-sum test was used to test the hypothesis of equal median reduction in PCH(T) from baseline between SPN-804 and placebo. The sample size of 120 patients per treatment arm provides over 95% power to detect a difference of 31% to 42% between placebo and 2400mg SPN-804 at a two-sided 0.025 level for an overall Type I error rate of 0.050.|
1715100|NCT00772590|3156180|Superiority or Other||||||<|0.01|||||||ANOVA||||
1715101|NCT00772538|3156186|Superiority or Other||Odds Ratio (OR)|1.68||||0.0001|2-Sided|95.0|1.28|2.21||Calculated as 2*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 48 weeks|
1715102|NCT00772538|3156186|Superiority or Other||Odds Ratio (OR)|1.32||||0.0427|2-Sided|95.0|1.01|1.73||Calculated as 2*one-sided-p-value in the direction corresponding to testing the null hypothesis|Fisher Exact||Tio R5 / Placebo|Comparison at 24 weeks|
1715103|NCT00772538|3156187|Superiority or Other||Mean Difference (Final Values)|-0.092|Standard Error of the Mean|0.172||0.5927||95.0|-0.43|0.246||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715104|NCT00772538|3156188|Superiority or Other||Mean Difference (Final Values)|-0.001|Standard Error of the Mean|0.024||0.9807||95.0|-0.048|0.047||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715105|NCT00772538|3156189|Superiority or Other||Mean Difference (Final Values)|-0.121|Standard Error of the Mean|0.067||0.0727||95.0|-0.253|0.011||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715106|NCT00772538|3156190|Superiority or Other||Mean Difference (Final Values)|-0.126|Standard Error of the Mean|0.066||0.0586||95.0|-0.256|0.005||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715107|NCT00772538|3156191|Superiority or Other||Mean Difference (Final Values)|0.038|Standard Error of the Mean|0.075||0.6099||95.0|-0.109|0.185||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715108|NCT00772538|3156192|Superiority or Other||Mean Difference (Final Values)|0.042|Standard Error of the Mean|0.074||0.5714||95.0|-0.103|0.186||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715109|NCT00772538|3156193|Superiority or Other||Odds Ratio (OR)|0.74||||0.633||95.0|0.25|2.13||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo||
1715110|NCT00772538|3156194|Superiority or Other||Risk Ratio (RR)|0.87|Standard Error of the Mean|0.21||0.5538||95.0|0.54|1.39||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo||
1715111|NCT00772538|3156195|Superiority or Other||Hazard Ratio (HR)|0.76||||0.5604||95.0|0.3|1.92||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium||
1715112|NCT00772538|3156196|Superiority or Other||Odds Ratio (OR)|0.65||||0.0561||95.0|0.42|1.01||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo||
1715113|NCT00772538|3156197|Superiority or Other||Odds Ratio (OR)|0.59||||0.0065||95.0|0.4|0.88||Significance level of alpha=0.05 (two-sided).|Fisher Exact|Exact 95percent confidence interval by Clopper and Pearson.|Tio R5 vs Placebo||
1715114|NCT00772538|3156198|Superiority or Other||Risk Ratio (RR)|0.64|Standard Error of the Mean|0.1||0.0062||95.0|0.46|0.88||Significance level of alpha=0.05 (two-sided).|Poisson Regression|Parameter estimates of Poisson regression model. Log exposure was used as offset and adjusted for overdispersion.|Tio R5 - Placebo||
1715135|NCT00772031|3156253|Superiority or Other||Mean Difference (Net)|-0.28|Standard Deviation|3.75||0.91||95.0|||||ANCOVA||||
1715116|NCT00772538|3156200|Superiority or Other||Hazard Ratio (HR)|0.7||||0.0499||95.0|0.49|1.0||Significance level of alpha=0.05 (two-sided).|Regression, Cox|Parameter estimates of Cox proportional hazard model regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.||
1715117|NCT00772538|3156201|Superiority or Other||Mean Difference (Final Values)|0.283|Standard Error of the Mean|0.736||0.7012||95.0|-1.165|1.731||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715118|NCT00772538|3156202|Superiority or Other||Mean Difference (Final Values)|0.124|Standard Error of the Mean|0.029|<|0.0001||95.0|0.068|0.181||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715119|NCT00772538|3156203|Superiority or Other||Mean Difference (Final Values)|0.117|Standard Error of the Mean|0.028|<|0.0001||95.0|0.061|0.173||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715120|NCT00772538|3156204|Superiority or Other||Mean Difference (Final Values)|23.267|Standard Error of the Mean|4.699|<|0.0001||95.0|14.027|32.507||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715121|NCT00772538|3156205|Superiority or Other||Mean Difference (Final Values)|22.293|Standard Error of the Mean|4.584|<|0.0001||95.0|13.279|31.308||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715122|NCT00772538|3156206|Superiority or Other||Mean Difference (Final Values)|0.122|Standard Error of the Mean|0.041||0.0027||95.0|0.042|0.201||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715123|NCT00772538|3156207|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|0.04||0.0063||95.0|0.031|0.19||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715124|NCT00772538|3156208|Superiority or Other||Mean Difference (Final Values)|0.125|Standard Error of the Mean|0.043||0.0039||95.0|0.04|0.21||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715125|NCT00772538|3156209|Superiority or Other||Mean Difference (Final Values)|0.073|Standard Error of the Mean|0.032||0.0247||95.0|0.009|0.136||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715126|NCT00772538|3156210|Superiority or Other||Mean Difference (Final Values)|0.042|Standard Error of the Mean|0.032||0.1896||95.0|-0.021|0.104||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715127|NCT00772538|3156211|Superiority or Other||Mean Difference (Final Values)|0.073|Standard Error of the Mean|0.034||0.0347||95.0|0.005|0.14||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715128|NCT00772538|3156212|Superiority or Other||Mean Difference (Final Values)|0.098|Standard Error of the Mean|0.04||0.0139||95.0|0.02|0.176||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715129|NCT00772538|3156213|Superiority or Other||Mean Difference (Final Values)|0.086|Standard Error of the Mean|0.032||0.0067||95.0|0.024|0.149||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715130|NCT00772538|3156214|Superiority or Other||Mean Difference (Final Values)|0.136|Standard Error of the Mean|0.04||0.0007||95.0|0.058|0.214||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715131|NCT00772538|3156215|Superiority or Other||Mean Difference (Final Values)|0.089|Standard Error of the Mean|0.043||0.0362||95.0|0.006|0.173||Significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715132|NCT00772538|3156216|Superiority or Other||Hazard Ratio (HR)|0.79||||0.0343||||||Confirmatory only if previous hypotheses for each of the 2 twin studies had been successful, significance level of alpha=0.05 (2-sided). A pre-specified interim analysis was performed. Cui et al (Biometrics,1999) was used to calculate the p-value.|Regression, Cox|Parameter estimates of Cox proportional hazard model regression regarding. Only treatment was fitted as an effect in the model.|If HR is below 1 then favours tiotropium.||
1715133|NCT00772538|3156217|Superiority or Other||Mean Difference (Final Values)|0.088|Standard Error of the Mean|0.031||0.005||95.0|0.027|0.149||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|REML-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715134|NCT00772538|3156218|Superiority or Other||Mean Difference (Final Values)|0.086|Standard Error of the Mean|0.034||0.011||95.0|0.02|0.152||Step-wise testing for co-primary endpoints, confirmatory only if previous hypotheses had been successful, significance level of alpha=0.05 (two-sided).|Mixed Models Analysis|Restricted maximum likelihood (REML)-based repeated measures approach (MMRM).|Tio R5 - Placebo. Means are adjusted for treatment, centre, visit, baseline, treatment*visit and baseline*visit.||
1715138|NCT00772031|3156257|Superiority or Other||Mean Difference (Net)|0.3|Standard Error of the Mean|0.97||0.77|2-Sided|95.0|-1.8|2.4|||ANCOVA|covariate adjustments: study site, baseline mod-to-sev 28-day headache-rate, topiramate use, medication overuse, and anti-depressive medications use.|Topiramate plus placebo mean reduction minus topiramate plus propranolol reduction|The study was designed to enroll 250 subjects to provide at least 90% power to detect a 3-day difference and 87% power to detect a 2.5-day difference in 28-day moderate-to-severe headache rate reductions at six months, assuming a type I error rate of 0.05, a two-sided test, a 10% loss to follow-up and a standard deviation of within-person change in days with headache of six.|
1715139|NCT00772005|3156317|Superiority or Other|||||||0.9464|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715140|NCT00772005|3156317|Superiority or Other|||||||0.0144|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715141|NCT00772005|3156317|Superiority or Other|||||||0.822|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715142|NCT00772005|3156318|Superiority or Other|||||||0.104|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715143|NCT00772005|3156318|Superiority or Other|||||||0.0068|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715144|NCT00772005|3156318|Superiority or Other|||||||0.733|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715145|NCT00772005|3156319|Superiority or Other|||||||0.5013|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715146|NCT00772005|3156319|Superiority or Other|||||||0.0021|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715147|NCT00772005|3156319|Superiority or Other|||||||0.9705|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715148|NCT00772005|3156320|Superiority or Other|||||||0.6867|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715149|NCT00772005|3156320|Superiority or Other|||||||0.4531|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715150|NCT00772005|3156320|Superiority or Other|||||||0.8457|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715151|NCT00772005|3156321|Superiority or Other|||||||0.3368|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715152|NCT00772005|3156321|Superiority or Other|||||||0.6091|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715153|NCT00772005|3156321|Superiority or Other|||||||0.761|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715154|NCT00772005|3156322|Superiority or Other|||||||0.7283|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715155|NCT00772005|3156322|Superiority or Other|||||||0.8299|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715156|NCT00772005|3156322|Superiority or Other|||||||0.4305|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715157|NCT00772005|3156323|Superiority or Other|||||||0.5644|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715158|NCT00772005|3156323|Superiority or Other|||||||0.0739|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715159|NCT00772005|3156323|Superiority or Other|||||||0.2518|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715160|NCT00772005|3156324|Superiority or Other|||||||0.6907|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715161|NCT00772005|3156324|Superiority or Other|||||||0.3003|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715162|NCT00772005|3156324|Superiority or Other|||||||0.4164|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715163|NCT00772005|3156325|Superiority or Other|||||||0.9235|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715164|NCT00772005|3156325|Superiority or Other|||||||0.0953|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715165|NCT00772005|3156325|Superiority or Other|||||||0.3355|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715166|NCT00772005|3156326|Superiority or Other|||||||0.6652|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715167|NCT00772005|3156326|Superiority or Other|||||||0.0262|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715168|NCT00772005|3156326|Superiority or Other|||||||0.6597|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715169|NCT00772005|3156327|Superiority or Other|||||||0.4213|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715170|NCT00772005|3156327|Superiority or Other|||||||0.8783|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715171|NCT00772005|3156327|Superiority or Other|||||||0.4646|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715172|NCT00772005|3156328|Superiority or Other|||||||0.7322|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715173|NCT00772005|3156328|Superiority or Other|||||||0.027|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715174|NCT00772005|3156328|Superiority or Other|||||||0.3686|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715175|NCT00772005|3156329|Superiority or Other|||||||0.9562|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715176|NCT00772005|3156329|Superiority or Other|||||||0.8243|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715177|NCT00772005|3156329|Superiority or Other|||||||0.4874|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715178|NCT00772005|3156330|Superiority or Other|||||||0.4424|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715179|NCT00772005|3156330|Superiority or Other|||||||0.7474|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715180|NCT00772005|3156330|Superiority or Other|||||||0.6059|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715878|NCT00764478|3157484|Superiority or Other|||||||0.0147|||||||Cochran-Mantel-Haenszel|||Day 21|
1715181|NCT00772005|3156331|Superiority or Other|||||||0.5439|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715182|NCT00772005|3156331|Superiority or Other|||||||0.8469|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715183|NCT00772005|3156331|Superiority or Other|||||||0.3466|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715184|NCT00772005|3156332|Superiority or Other|||||||0.9739|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715185|NCT00772005|3156332|Superiority or Other|||||||0.9783|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715186|NCT00772005|3156332|Superiority or Other|||||||0.6042|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715187|NCT00772005|3156333|Superiority or Other|||||||0.6955|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715188|NCT00772005|3156333|Superiority or Other|||||||0.4204|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715189|NCT00772005|3156333|Superiority or Other|||||||0.6487|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715190|NCT00772005|3156334|Superiority or Other|||||||0.8811|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715191|NCT00772005|3156334|Superiority or Other|||||||0.5464|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715192|NCT00772005|3156334|Superiority or Other|||||||0.9812|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715193|NCT00772005|3156335|Superiority or Other|||||||0.9144|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715194|NCT00772005|3156335|Superiority or Other|||||||0.5378|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715195|NCT00772005|3156335|Superiority or Other|||||||0.8115|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715196|NCT00772005|3156336|Superiority or Other|||||||0.9764|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715197|NCT00772005|3156336|Superiority or Other|||||||0.4701|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715198|NCT00772005|3156336|Superiority or Other|||||||0.9093|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715199|NCT00772005|3156337|Superiority or Other|||||||0.9343|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715200|NCT00772005|3156337|Superiority or Other|||||||0.5443|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715201|NCT00772005|3156337|Superiority or Other|||||||0.6885|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715202|NCT00772005|3156338|Superiority or Other|||||||0.7455|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715879|NCT00764478|3157484|Superiority or Other|||||||0.0048|||||||Cochran-Mantel-Haenszel|||Day 14|
1715203|NCT00772005|3156338|Superiority or Other|||||||0.1732|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715204|NCT00772005|3156338|Superiority or Other|||||||0.5195|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715205|NCT00772005|3156339|Superiority or Other|||||||0.4092|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715206|NCT00772005|3156339|Superiority or Other|||||||0.5239|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715207|NCT00772005|3156339|Superiority or Other|||||||0.5676|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715208|NCT00772005|3156340|Superiority or Other|||||||0.8655|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715209|NCT00772005|3156340|Superiority or Other|||||||0.6246|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715210|NCT00772005|3156340|Superiority or Other|||||||0.4022|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715211|NCT00772005|3156341|Superiority or Other|||||||0.6504|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715212|NCT00772005|3156341|Superiority or Other|||||||0.4294|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715213|NCT00772005|3156341|Superiority or Other|||||||0.1878|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715214|NCT00772005|3156342|Superiority or Other|||||||0.0946|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715215|NCT00772005|3156342|Superiority or Other|||||||0.5324|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715216|NCT00772005|3156342|Superiority or Other|||||||0.069|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715217|NCT00772005|3156343|Superiority or Other|||||||0.4585|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715218|NCT00772005|3156343|Superiority or Other|||||||0.5179|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715219|NCT00772005|3156343|Superiority or Other|||||||0.7056|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715220|NCT00772005|3156344|Superiority or Other|||||||0.1491|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715221|NCT00772005|3156344|Superiority or Other|||||||0.9178|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715222|NCT00772005|3156344|Superiority or Other|||||||0.9565|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715223|NCT00772005|3156345|Superiority or Other|||||||0.1576|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715224|NCT00772005|3156345|Superiority or Other|||||||0.5761|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715880|NCT00764478|3157484|Superiority or Other|||||||0.0866|||||||Cochran-Mantel-Haenszel|||Day 14|
1715225|NCT00772005|3156345|Superiority or Other|||||||0.7612|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715226|NCT00772005|3156346|Superiority or Other|||||||0.4848|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715227|NCT00772005|3156346|Superiority or Other|||||||0.9116|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715228|NCT00772005|3156346|Superiority or Other|||||||0.9258|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715229|NCT00772005|3156347|Superiority or Other|||||||0.0463|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715230|NCT00772005|3156347|Superiority or Other|||||||0.6043|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715231|NCT00772005|3156347|Superiority or Other|||||||0.3547|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715232|NCT00772005|3156348|Superiority or Other|||||||0.372|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715233|NCT00772005|3156348|Superiority or Other|||||||0.1737|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715234|NCT00772005|3156348|Superiority or Other|||||||0.167|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715235|NCT00772005|3156349|Superiority or Other|||||||0.0647|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715236|NCT00772005|3156349|Superiority or Other|||||||0.1475|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715237|NCT00772005|3156349|Superiority or Other|||||||0.2681|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715238|NCT00772005|3156350|Superiority or Other|||||||0.0083|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715239|NCT00772005|3156350|Superiority or Other|||||||0.3056|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715240|NCT00772005|3156350|Superiority or Other|||||||0.1715|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715241|NCT00772005|3156351|Superiority or Other|||||||0.4753|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715242|NCT00772005|3156351|Superiority or Other|||||||0.6597|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715243|NCT00772005|3156351|Superiority or Other|||||||0.2425|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715244|NCT00772005|3156352|Superiority or Other|||||||0.3125|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715245|NCT00772005|3156352|Superiority or Other|||||||0.6211|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715246|NCT00772005|3156352|Superiority or Other|||||||0.2318|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715881|NCT00764478|3157484|Superiority or Other|||||||0.0021|||||||Cochran-Mantel-Haenszel|||Day 7|
1715247|NCT00772005|3156353|Superiority or Other|||||||0.0328|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715248|NCT00772005|3156353|Superiority or Other|||||||0.5859|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715249|NCT00772005|3156353|Superiority or Other|||||||0.9871|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715250|NCT00772005|3156354|Superiority or Other|||||||0.6493|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715251|NCT00772005|3156354|Superiority or Other|||||||0.3777|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715252|NCT00772005|3156354|Superiority or Other|||||||0.403|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715253|NCT00772005|3156355|Superiority or Other|||||||0.3973|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715254|NCT00772005|3156355|Superiority or Other|||||||0.5879|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715255|NCT00772005|3156355|Superiority or Other|||||||0.9786|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715256|NCT00772005|3156356|Superiority or Other|||||||0.8112|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715257|NCT00772005|3156356|Superiority or Other|||||||0.687|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715258|NCT00772005|3156356|Superiority or Other|||||||0.8116|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715259|NCT00772005|3156357|Superiority or Other|||||||0.3406|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715260|NCT00772005|3156357|Superiority or Other|||||||0.2538|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715261|NCT00772005|3156357|Superiority or Other|||||||0.4607|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715262|NCT00772005|3156358|Superiority or Other|||||||0.063|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715263|NCT00772005|3156358|Superiority or Other|||||||0.1352|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715264|NCT00772005|3156358|Superiority or Other|||||||0.5722|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715265|NCT00772005|3156359|Superiority or Other|||||||0.1455|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715266|NCT00772005|3156359|Superiority or Other|||||||0.7814|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715267|NCT00772005|3156359|Superiority or Other|||||||0.9642|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715268|NCT00772005|3156360|Superiority or Other|||||||0.1348|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715882|NCT00764478|3157484|Superiority or Other|||||||0.0583|||||||Cochran-Mantel-Haenszel|||Day 7|
1715269|NCT00772005|3156360|Superiority or Other|||||||0.3773|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715270|NCT00772005|3156360|Superiority or Other|||||||0.1292|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715271|NCT00772005|3156361|Superiority or Other|||||||0.0146|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715272|NCT00772005|3156361|Superiority or Other|||||||0.0419|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715273|NCT00772005|3156361|Superiority or Other|||||||0.1348|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715274|NCT00772005|3156362|Superiority or Other|||||||0.1181|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715275|NCT00772005|3156362|Superiority or Other|||||||0.227|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715276|NCT00772005|3156362|Superiority or Other|||||||0.0194|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715277|NCT00772005|3156363|Superiority or Other|||||||0.058|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715278|NCT00772005|3156363|Superiority or Other|||||||0.0617|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715279|NCT00772005|3156363|Superiority or Other|||||||0.3045|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715280|NCT00772005|3156364|Superiority or Other|||||||0.7865|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715281|NCT00772005|3156364|Superiority or Other|||||||0.5827|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715282|NCT00772005|3156364|Superiority or Other|||||||0.6076|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715283|NCT00772005|3156365|Superiority or Other|||||||0.4846|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715284|NCT00772005|3156365|Superiority or Other|||||||0.6157|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715285|NCT00772005|3156365|Superiority or Other|||||||0.8594|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715286|NCT00772005|3156366|Superiority or Other|||||||0.6097|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715287|NCT00772005|3156366|Superiority or Other|||||||0.4814|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715288|NCT00772005|3156366|Superiority or Other|||||||0.9193|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715289|NCT00772005|3156367|Superiority or Other|||||||0.3127|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715290|NCT00772005|3156367|Superiority or Other|||||||0.4503|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715883|NCT00764478|3157484|Superiority or Other|||||||0.028|||||||Cochran-Mantel-Haenszel|||Day 4|
1715291|NCT00772005|3156367|Superiority or Other|||||||0.7472|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715292|NCT00772005|3156368|Superiority or Other|||||||0.3152|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715293|NCT00772005|3156368|Superiority or Other|||||||0.6637|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715294|NCT00772005|3156368|Superiority or Other|||||||0.8695|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715295|NCT00772005|3156369|Superiority or Other|||||||0.5895|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715296|NCT00772005|3156369|Superiority or Other|||||||0.9428|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715297|NCT00772005|3156369|Superiority or Other|||||||0.9337|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715298|NCT00772005|3156370|Superiority or Other|||||||0.5489|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715299|NCT00772005|3156370|Superiority or Other|||||||0.8679|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715300|NCT00772005|3156370|Superiority or Other|||||||0.6378|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715301|NCT00772005|3156371|Superiority or Other|||||||0.1795|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715302|NCT00772005|3156371|Superiority or Other|||||||0.891|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715303|NCT00772005|3156371|Superiority or Other|||||||0.5879|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715304|NCT00772005|3156372|Superiority or Other|||||||0.3183|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715305|NCT00772005|3156372|Superiority or Other|||||||0.7522|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715306|NCT00772005|3156372|Superiority or Other|||||||0.5312|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715307|NCT00772005|3156373|Superiority or Other|||||||0.9748|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715308|NCT00772005|3156373|Superiority or Other|||||||0.2543|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715309|NCT00772005|3156373|Superiority or Other|||||||0.1914|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715310|NCT00772005|3156374|Superiority or Other|||||||0.4483|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715311|NCT00772005|3156374|Superiority or Other|||||||0.4446|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715312|NCT00772005|3156374|Superiority or Other|||||||0.5544|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715884|NCT00764478|3157484|Superiority or Other|||||||0.1264|||||||Cochran-Mantel-Haenszel|||Day 4|
1715313|NCT00772005|3156375|Superiority or Other|||||||0.4378|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715314|NCT00772005|3156375|Superiority or Other|||||||0.8777|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715315|NCT00772005|3156375|Superiority or Other|||||||0.632|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715316|NCT00772005|3156376|Superiority or Other|||||||0.189|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715317|NCT00772005|3156376|Superiority or Other|||||||0.9355|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715318|NCT00772005|3156376|Superiority or Other|||||||0.2076|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715319|NCT00772005|3156377|Superiority or Other|||||||0.5002|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715320|NCT00772005|3156377|Superiority or Other|||||||0.4866|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715321|NCT00772005|3156377|Superiority or Other|||||||0.7649|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715322|NCT00772005|3156378|Superiority or Other|||||||0.1507|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715323|NCT00772005|3156378|Superiority or Other|||||||0.664|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715324|NCT00772005|3156378|Superiority or Other|||||||0.0974|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715325|NCT00772005|3156379|Superiority or Other|||||||0.1342|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715326|NCT00772005|3156379|Superiority or Other|||||||0.4457|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715327|NCT00772005|3156379|Superiority or Other|||||||0.261|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715328|NCT00772005|3156380|Superiority or Other|||||||0.1566|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715329|NCT00772005|3156380|Superiority or Other|||||||0.7411|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715330|NCT00772005|3156380|Superiority or Other|||||||0.5989|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715331|NCT00772005|3156381|Superiority or Other|||||||0.1426|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715332|NCT00772005|3156381|Superiority or Other|||||||0.6028|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715333|NCT00772005|3156381|Superiority or Other|||||||0.584|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715334|NCT00772005|3156382|Superiority or Other|||||||0.2129|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715885|NCT00764478|3157484|Superiority or Other|||||||0.0771|||||||Cochran-Mantel-Haenszel|||Day 2|
1715335|NCT00772005|3156382|Superiority or Other|||||||0.194|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715336|NCT00772005|3156382|Superiority or Other|||||||0.3536|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715337|NCT00772005|3156383|Superiority or Other|||||||0.5674|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715338|NCT00772005|3156383|Superiority or Other|||||||0.8335|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715339|NCT00772005|3156383|Superiority or Other|||||||0.9472|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715340|NCT00772005|3156384|Superiority or Other|||||||0.9035|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715341|NCT00772005|3156384|Superiority or Other|||||||0.949|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715342|NCT00772005|3156384|Superiority or Other|||||||0.2476|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715343|NCT00772005|3156385|Superiority or Other|||||||0.604|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715344|NCT00772005|3156385|Superiority or Other|||||||0.4543|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715345|NCT00772005|3156385|Superiority or Other|||||||0.7599|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715346|NCT00772005|3156386|Superiority or Other|||||||0.9808|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715347|NCT00772005|3156386|Superiority or Other|||||||0.2418|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715348|NCT00772005|3156386|Superiority or Other|||||||0.6759|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715349|NCT00772005|3156387|Superiority or Other|||||||0.2959|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715350|NCT00772005|3156387|Superiority or Other|||||||0.0807|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715351|NCT00772005|3156387|Superiority or Other|||||||0.4608|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715352|NCT00772005|3156388|Superiority or Other|||||||0.015|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715353|NCT00772005|3156388|Superiority or Other|||||||0.0104|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715354|NCT00772005|3156388|Superiority or Other|||||||0.2981|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715355|NCT00772005|3156389|Superiority or Other|||||||0.0625|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715356|NCT00772005|3156389|Superiority or Other|||||||0.2003|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715886|NCT00764478|3157484|Superiority or Other|||||||0.0377|||||||Cochran-Mantel-Haenszel|||Day 2|
1715357|NCT00772005|3156389|Superiority or Other|||||||0.3825|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715358|NCT00772005|3156390|Superiority or Other|||||||0.2655|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715359|NCT00772005|3156390|Superiority or Other|||||||0.5106|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715360|NCT00772005|3156390|Superiority or Other|||||||0.9577|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715361|NCT00772005|3156391|Superiority or Other|||||||0.7061|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715362|NCT00772005|3156391|Superiority or Other|||||||0.8374|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715363|NCT00772005|3156391|Superiority or Other|||||||0.9769|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715364|NCT00772005|3156392|Superiority or Other|||||||0.319|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715365|NCT00772005|3156392|Superiority or Other|||||||0.9373|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715366|NCT00772005|3156392|Superiority or Other|||||||0.8228|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715367|NCT00772005|3156393|Superiority or Other|||||||0.2343|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715368|NCT00772005|3156393|Superiority or Other|||||||0.2233|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715369|NCT00772005|3156393|Superiority or Other|||||||0.6115|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715370|NCT00772005|3156394|Superiority or Other|||||||0.2447|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715371|NCT00772005|3156394|Superiority or Other|||||||0.3345|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715372|NCT00772005|3156394|Superiority or Other|||||||0.6948|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715373|NCT00772005|3156395|Superiority or Other|||||||0.0883|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715374|NCT00772005|3156395|Superiority or Other|||||||0.9748|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715375|NCT00772005|3156395|Superiority or Other|||||||0.8835|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715376|NCT00772005|3156396|Superiority or Other|||||||0.0926|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715377|NCT00772005|3156396|Superiority or Other|||||||0.349|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715378|NCT00772005|3156396|Superiority or Other|||||||0.3316|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715887|NCT00764478|3157485|Superiority or Other|||||||0.0025|||||||Cochran-Mantel-Haenszel|||Day 21|
1715379|NCT00772005|3156397|Superiority or Other|||||||0.038|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715380|NCT00772005|3156397|Superiority or Other|||||||0.3528|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715381|NCT00772005|3156397|Superiority or Other|||||||0.2664|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715382|NCT00772005|3156398|Superiority or Other|||||||0.0309|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715383|NCT00772005|3156398|Superiority or Other|||||||0.8715|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715384|NCT00772005|3156398|Superiority or Other|||||||0.8455|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715385|NCT00772005|3156399|Superiority or Other|||||||0.0192|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715386|NCT00772005|3156399|Superiority or Other|||||||0.6004|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715387|NCT00772005|3156399|Superiority or Other|||||||0.1459|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715388|NCT00772005|3156400|Superiority or Other|||||||0.6271|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715389|NCT00772005|3156400|Superiority or Other|||||||0.358|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715390|NCT00772005|3156400|Superiority or Other|||||||0.454|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715391|NCT00772005|3156410|Superiority or Other|||||||0.4999|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715392|NCT00772005|3156410|Superiority or Other|||||||0.8961|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715393|NCT00772005|3156410|Superiority or Other|||||||0.8124|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715394|NCT00772005|3156411|Superiority or Other|||||||0.7395|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715395|NCT00772005|3156411|Superiority or Other|||||||0.6642|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715396|NCT00772005|3156411|Superiority or Other|||||||0.3547|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715397|NCT00772005|3156412|Superiority or Other|||||||0.5415|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715398|NCT00772005|3156412|Superiority or Other|||||||0.6173|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715399|NCT00772005|3156412|Superiority or Other|||||||0.9797|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715400|NCT00772005|3156413|Superiority or Other|||||||0.9528|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715888|NCT00764478|3157485|Superiority or Other|||||||0.0525|||||||Cochran-Mantel-Haenszel|||Day 21|
1715401|NCT00772005|3156413|Superiority or Other|||||||0.3604|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715402|NCT00772005|3156413|Superiority or Other|||||||0.996|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715403|NCT00772005|3156414|Superiority or Other|||||||0.3052|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715404|NCT00772005|3156414|Superiority or Other|||||||0.0706|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715405|NCT00772005|3156414|Superiority or Other|||||||0.2091|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715406|NCT00772005|3156415|Superiority or Other|||||||0.0327|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715407|NCT00772005|3156415|Superiority or Other|||||||0.0096|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715408|NCT00772005|3156415|Superiority or Other|||||||0.3651|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715409|NCT00772005|3156416|Superiority or Other|||||||0.0084|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715410|NCT00772005|3156416|Superiority or Other|||||||0.0328|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715411|NCT00772005|3156416|Superiority or Other|||||||0.0524|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715412|NCT00772005|3156417|Superiority or Other|||||||0.266|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715413|NCT00772005|3156417|Superiority or Other|||||||0.2958|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715414|NCT00772005|3156417|Superiority or Other|||||||0.8847|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715415|NCT00772005|3156418|Superiority or Other|||||||0.2424|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715416|NCT00772005|3156418|Superiority or Other|||||||0.9704|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715417|NCT00772005|3156418|Superiority or Other|||||||0.5612|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715418|NCT00772005|3156419|Superiority or Other|||||||0.4016|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715419|NCT00772005|3156419|Superiority or Other|||||||0.4014|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715420|NCT00772005|3156419|Superiority or Other|||||||0.7768|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715421|NCT00772005|3156420|Superiority or Other|||||||0.1591|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715422|NCT00772005|3156420|Superiority or Other|||||||0.3195|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715889|NCT00764478|3157485|Superiority or Other|||||||0.0009|||||||Cochran-Mantel-Haenszel|||Day 14|
1715423|NCT00772005|3156420|Superiority or Other|||||||0.4291|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715424|NCT00772005|3156421|Superiority or Other|||||||0.1097|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715425|NCT00772005|3156421|Superiority or Other|||||||0.5129|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715426|NCT00772005|3156421|Superiority or Other|||||||0.7093|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715427|NCT00772005|3156422|Superiority or Other|||||||0.0598|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715428|NCT00772005|3156422|Superiority or Other|||||||0.1137|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715429|NCT00772005|3156422|Superiority or Other|||||||0.0619|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715430|NCT00772005|3156423|Superiority or Other|||||||0.0063|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715431|NCT00772005|3156423|Superiority or Other|||||||0.0431|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715432|NCT00772005|3156423|Superiority or Other|||||||0.0713|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715433|NCT00772005|3156424|Superiority or Other|||||||0.0039|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715434|NCT00772005|3156424|Superiority or Other|||||||0.2597|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715435|NCT00772005|3156424|Superiority or Other|||||||0.3275|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715436|NCT00772005|3156425|Superiority or Other|||||||0.0327|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715437|NCT00772005|3156425|Superiority or Other|||||||0.4582|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715438|NCT00772005|3156425|Superiority or Other|||||||0.1894|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715439|NCT00772005|3156426|Superiority or Other|||||||0.6688|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715440|NCT00772005|3156426|Superiority or Other|||||||0.562|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715441|NCT00772005|3156426|Superiority or Other|||||||0.7596|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715442|NCT00772005|3156427|Superiority or Other|||||||0.9766|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715443|NCT00772005|3156427|Superiority or Other|||||||0.6995|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715444|NCT00772005|3156427|Superiority or Other|||||||0.8514|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value and 95% CI for the treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1715890|NCT00764478|3157485|Superiority or Other|||||||0.2401|||||||Cochran-Mantel-Haenszel|||Day 14|
1715445|NCT00771914|3156431|Superiority or Other||Mean Difference (Final Values)|30.0||||0.03|2-Sided|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from both Aspirin and Lovaza compared to Placebo.|
1715446|NCT00771914|3156431|Superiority or Other||Mean Difference (Final Values)|-8.0||||0.49|2-Sided|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from Lovaza compared to Placebo.|
1715447|NCT00771914|3156431|Superiority or Other||Median Difference (Final Values)|12.0||||0.31|2-Sided|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from Aspirin compared to Placebo.|
1715448|NCT00771914|3156431|Superiority or Other||Mean Difference (Final Values)|0.0||||0|2-Sided|95.0||||The analyses were not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The Wilcoxon Signed-Rank Test was used to determine significant differences between the closure time effect (clotting)in seconds from baseline compared to four hours after placebo.|
1715449|NCT00771667|3156506|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for induction dose and clinical remission status at Week 6.|||
1715450|NCT00771667|3156507|Superiority or Other|||||||0.029||||||Testing for Week-22 clinical remission was performed if the comparison of 6-mg/kg ustekinumab with placebo was positive for the primary endpoint.|Cochran-Mantel-Haenszel|The CMH test chi-square test, stratified by IV induction dose and clinical remission status at Week 6.|||
1715451|NCT00771667|3156508|Superiority or Other|||||||0.105|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715452|NCT00771667|3156508|Superiority or Other|||||||0.081|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715453|NCT00771667|3156508|Superiority or Other|||||||0.074|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715454|NCT00771667|3156509|Superiority or Other|||||||0.006|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715455|NCT00771667|3156509|Superiority or Other|||||||0.007|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715456|NCT00771667|3156509|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715457|NCT00771667|3156510|Superiority or Other|||||||0.035|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715458|NCT00771667|3156510|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715459|NCT00771667|3156510|Superiority or Other||||||<|0.008|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715460|NCT00771667|3156511|Superiority or Other|||||||0.196|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715461|NCT00771667|3156511|Superiority or Other|||||||0.206|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715462|NCT00771667|3156511|Superiority or Other|||||||0.682|||||||Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715463|NCT00771667|3156512|Superiority or Other|||||||0.021||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715464|NCT00771667|3156512|Superiority or Other|||||||0.057||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715465|NCT00771667|3156512|Superiority or Other|||||||0.005||||||A fixed sequence testing procedure was employed to control the type I error rate at 0.05 level for the primary endpoint, beginning with the highest dose.|Cochran-Mantel-Haenszel|The CMH test is controlling for anti-TNF status.|||
1715466|NCT00771537|3156536|Superiority or Other||Marginal Means|2.47|Standard Error of the Mean|0.036|<|0.91|2-Sided|95.0|2.4|2.54|||ANOVA||There was no significant effect for the 2-sided major message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-Way Analysis of Variance|
1715467|NCT00771537|3156536|Superiority or Other||Marginal Means|2.51|Standard Error of the Mean|0.036|<|0.25|2-Sided|95.0|2.44|2.58|||ANOVA|degrees of freedom = (1,1028)|There was no significant effect for the 2-sided trivial message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-Way Analysis of Variance|
1715468|NCT00771537|3156536|Superiority or Other||Marginal Means|2.49|Standard Error of the Mean|0.037|<|0.6|2-Sided|95.0|2.42|2.56|||ANOVA|Degrees of freedom = (1,978)|There was no significant effect for the 1-sided message compared to the control group on Willingness to Participate in an HIV vaccine clinical trial.|One-way Analysis of Variance|
1715469|NCT00771537|3156537|Superiority or Other||Odds Ratio (OR)|0.92|Standard Error of the Mean|0.176||0.63|2-Sided|95.0|0.65|1.3|||Regression, Logistic||Women in the 2-sided major group were no different in rates of accepting HIV testing (83.9%) than women in the control group (87.4%)||
1715470|NCT00771537|3156537|Superiority or Other||Odds Ratio (OR)|0.75|Standard Error of the Mean|0.17||0.1|2-Sided|95.0|0.54|1.04|||Regression, Logistic||Women in the 2-sided trivial group were no different in their acceptance rate of HIV testing (81.3%) than women in the control group (87.4%).||
1715471|NCT00771537|3156537|Superiority or Other||Odds Ratio (OR)|0.69|Standard Error of the Mean|0.17||0.05|2-Sided|95.0|0.5|0.96|||Regression, Logistic||Women in the 1-sided message group accepted testing at a lower rate (79.4%) than those in the control group (87.4%).||
1715509|NCT00770653|3156618|Superiority or Other||Mean Difference (Final Values)|-0.2355||||0.9464|2-Sided|95.0|-7.1253|6.6543|||ANCOVA||||
1715510|NCT00770653|3156619|Superiority or Other||Mean Difference (Final Values)|3.1292||||0.7486|2-Sided|95.0|-17.0109|23.2693|||ANCOVA||||
1715511|NCT00770653|3156620|Superiority or Other||Mean Difference (Final Values)|-17.9479||||0.1012|2-Sided|95.0|-39.4331|3.5373|||ANCOVA||||
1715512|NCT00770653|3156621|Superiority or Other||Mean Difference (Final Values)|-0.1311||||0.1167|2-Sided|95.0|-0.2951|0.0329|||ANCOVA||||
1715472|NCT00771264|3156554|Superiority or Other|||||||0.05||||||P-values <0.05 were considered statistically significant.|t-test, 2 sided|Mean values were analyzed for significant change using a 2-sided paired t-test and proportions were analyzed using chi-square methodology.||Mean values were analyzed for significant change using a 2-sided paired t test and proportions were analyzed using chi-square methodology. Median values were analyzed using a Wilcoxon signed rank test with p<0.05 considered statistically significant. A sample size estimate of 214 subjects, 107 per arm, was calculated using a 2-sided Fisher’s exact binomial test based on an estimated 60% responder rate in the PTNS group and a 40% in the sham group with a 5% significance level and 80% power.|
1715473|NCT00771173|3156557|Superiority or Other|||||||0.745|||||||t-test, 2 sided|||The independent samples t-test was used to test the null hypothesis that the mean VAS score for the active treatment cohort (i.e., those receiving pyridium) was no different than the mean VAS score for those receiving placebo.|
1715474|NCT00770991|3156560|Superiority or Other|||||||0.043|||||||Wilcoxon (Mann-Whitney)||||
1715475|NCT00770991|3156561|Superiority or Other|||||||0.016|||||||Chi-squared||||
1715476|NCT00770991|3156562|Superiority or Other|||||||0.065|||||||Wilcoxon (Mann-Whitney)|||All patients received BRB suppositories and were pooled for the analysis comparing baseline and end of study polyp counts.|
1715477|NCT00770874|3156567|Superiority||Hazard Ratio (HR)|0.62|||<|0.001|2-Sided|95.0|0.48|0.8|||Log Rank||||
1715478|NCT00770874|3156568|Superiority||Hazard Ratio (HR)|0.84||||0.125|2-Sided|95.0|0.67|1.05|||Log Rank||||
1715479|NCT00770861|3156569|Superiority or Other|||||||0.001|||||||ANCOVA||||
1715480|NCT00770861|3156570|Superiority or Other||||||<|0.0001|||||||ANCOVA|Between–treatment comparison of efficacy was performed by ANCOVA, with treatment, baseline BMI, center as factors & baseline value as a covariate.||H0 - There was no difference in BP reduction between Neb and Placebo. The efficacy analyses were based on the ITT population for the double-blind treatment phase. The LOCF was used to impute missing postbaseline values. Sensitivity analyses were based on observed cases for all efficacy parameters. All statistical tests were two-sided hypothesis tests performed at the 5% level of significance for main effects. All confidence intervals were two-sided 95% confidence intervals.|
1715481|NCT00770809|3156577|Superiority or Other (legacy)|||||||0.072||||||Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).|Log Rank||||
1715482|NCT00770809|3156577|Superiority or Other (legacy)|||||||0.13||||||Participants were stratified by clinical stage (II vs III) and hormone receptor status (positive/negative).|Log Rank||||
1715483|NCT00770653|3156592|Superiority or Other||Mean Difference (Final Values)|2.4181||||0.1165|2-Sided|95.0|-0.6561|5.4922|||ANCOVA||||
1715484|NCT00770653|3156593|Superiority or Other||Mean Difference (Final Values)|2.1346||||0.1363|2-Sided|95.0|-0.7338|5.0031|||ANCOVA||||
1715485|NCT00770653|3156594|Superiority or Other||Mean Difference (Final Values)|2.1718||||0.1013|2-Sided|95.0|-0.466|4.8097|||ANCOVA||||
1715486|NCT00770653|3156595|Superiority or Other||Mean Difference (Final Values)|2.5394||||0.0509|2-Sided|95.0|-0.0114|5.0901|||ANCOVA||||
1715487|NCT00770653|3156596|Superiority or Other||Mean Difference (Final Values)|2.9712||||0.0264|2-Sided|95.0|0.3863|5.5562|||ANCOVA||||
1715488|NCT00770653|3156597|Superiority or Other||Mean Difference (Final Values)|3.2345||||0.0055|2-Sided|95.0|1.0675|5.4016|||ANCOVA||||
1715489|NCT00770653|3156598|Superiority or Other||Mean Difference (Final Values)|2.5263||||0.0002|2-Sided|95.0|1.3832|3.6695|||ANCOVA||||
1715490|NCT00770653|3156599|Superiority or Other||Mean Difference (Final Values)|0.9935||||0.1761|2-Sided|95.0|-0.4843|2.4712|||ANCOVA||||
1715491|NCT00770653|3156600|Superiority or Other||Mean Difference (Final Values)|0.0009||||0.0817|2-Sided|95.0|-30.1139|1.8578|||ANCOVA||||
1715492|NCT00770653|3156601|Superiority or Other||Mean Difference (Final Values)|-2.4205||||0.0138|2-Sided|95.0|-4.3207|-0.5202|||ANCOVA||||
1715493|NCT00770653|3156602|Superiority or Other||Mean Difference (Final Values)|28.0794||||0.585|2-Sided|95.0|-95.6468|151.8057|||ANCOVA||||
1715494|NCT00770653|3156603|Superiority or Other||Mean Difference (Final Values)|-367.2639||||0.2203|2-Sided|95.0|-964.3923|229.8646|||ANCOVA||||
1715495|NCT00770653|3156604|Superiority or Other||Mean Difference (Final Values)|28.3988||||0.523|2-Sided|95.0|-60.7193|117.5169|||ANCOVA||||
1715496|NCT00770653|3156605|Superiority or Other||Mean Difference (Final Values)|-9.9728||||0.5058|2-Sided|95.0|-39.9915|20.0459|||ANCOVA||||
1715497|NCT00770653|3156606|Superiority or Other||Mean Difference (Final Values)|-24.8589||||0.7186|2-Sided|95.0|-163.3229|113.6052|||ANCOVA||||
1715498|NCT00770653|3156607|Superiority or Other||Mean Difference (Final Values)|-151.4477||||0.1979|2-Sided|95.0|-386.2256|83.3302|||ANCOVA||||
1715499|NCT00770653|3156608|Superiority or Other||Mean Difference (Final Values)|-29.9516||||0.3517|2-Sided|95.0|-94.1999|34.2967|||ANCOVA||||
1715500|NCT00770653|3156609|Superiority or Other||Fisher Exact|-3.33||||0.2895|2-Sided|95.0|-14.83|8.39|||Fisher Exact|||The number and percentage of participants with a calculated compliance >80% and <120% are presented for both treatment groups. In addition, the p-values of Fisher's exact test, the two-sided 95% confidence intervals for the percentage of patients per treatment group and for the difference between the treatment groups are provided.|
1715501|NCT00770653|3156610|Superiority or Other||Mean Difference (Final Values)|-0.8832||||0.3279|2-Sided|95.0|-2.6571|0.8906|||ANCOVA||||
1715502|NCT00770653|3156611|Superiority or Other||Mean Difference (Final Values)|-2.4903||||0.0929|2-Sided|95.0|-5.3979|0.4172|||ANCOVA||||
1715503|NCT00770653|3156612|Superiority or Other||Mean Difference (Final Values)|-0.8847|||<|0.0001|2-Sided|95.0|-1.3067|-0.4627|||ANCOVA||||
1715504|NCT00770653|3156613|Superiority or Other||Mean Difference (Final Values)|-0.8323||||0.4131|2-Sided|95.0|-2.8312|1.1665|||ANCOVA||||
1715505|NCT00770653|3156614|Superiority or Other||Mean Difference (Final Values)|6.3161|||<|0.0001|2-Sided|95.0|5.0994|7.5329|||ANCOVA||||
1715506|NCT00770653|3156615|Superiority or Other||Mean Difference (Final Values)|1.0707||||0.7799|2-Sided|95.0|-6.4665|8.6079|||ANCOVA||||
1715507|NCT00770653|3156616|Superiority or Other||Mean Difference (Final Values)|-4.5039|||<|0.0001|2-Sided|95.0|-6.4222|-2.5855|||ANCOVA||||
1715508|NCT00770653|3156617|Superiority or Other||Mean Difference (Final Values)|0.1574||||0.0807|2-Sided|95.0|-0.0193|0.3341|||ANCOVA||||
1715891|NCT00764478|3157485|Superiority or Other|||||||0.0017|||||||Cochran-Mantel-Haenszel|||Day 7|
1715513|NCT00770653|3156622|Superiority or Other||Mean Difference (Final Values)|3.267||||0.0018|2-Sided|95.0|1.2264|5.3076|||ANCOVA||Deviation from the normal distribution assumption was detected for original and rank-transformed data for all time-points due to p-value of Shapiro-Wilk test, indicating the normal distribution assumption might be distrusted for HDL-cholesterol data.||
1715514|NCT00770653|3156623|Superiority or Other||Mean Difference (Final Values)|3.267||||0.0018|2-Sided|95.0|1.2264|5.3076|||ANCOVA|||Null hypothesis (H0) = mean increase of HDL after 24 weeks of treatment of Pio/Met group ≤ the mean increase in the Gli/Met group. Alternate hypothesis (H1) = mean increase of HDL after 24 weeks of treatment of Pio/Met group > the mean increase in the Gli/Met group. The relevant clinical effect size to detect with adequate power was 0.35. With this assumption, a one sided t-test with a type I error rate had 80% power to reject the H0 for the H1 when the sample size was 130 patients per group.|
1715515|NCT00770562|3156630|Superiority or Other|||||||0.015|||||||Fisher Exact||||
1715516|NCT00770562|3156631|Superiority or Other|||||||0.001|||||||Fisher Exact||||
1715517|NCT00770562|3156632|Superiority or Other|||||||0.004|||||||Fisher Exact||||
1715518|NCT00770432|3156640|Superiority or Other|||||||0.0595|||||||Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel adjusted for study site (the smallest study sites were pooled according to a pre-specified rule).|||
1715519|NCT00770367|3156642|Non-Inferiority or Equivalence|Equivalence.|Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.05||0.37|2-Sided||||||t-test, 2 sided|||A twosample comparison of mean treatment differences conducted using a pre-determined significance level of alpha level <0.05. 2 a comparison of means for NOx levels at 12 weeks b/w groups. 3 on the change F2-isoprostanes at 12 weeks b/w groups.|
1715520|NCT00770328|3156651|Superiority|||||||0.0114|||||||Wilcoxon (Mann-Whitney)||||
1715521|NCT00770328|3156652|Superiority|||||||0.0005|||||||Wilcoxon (Mann-Whitney)||||
1715522|NCT00770315|3156653|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.0058|2-Sided|95.0|-1.89|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715523|NCT00770315|3156653|Superiority or Other||Mean Difference (Final Values)|-1.08||||0.0053|2-Sided|95.0|-1.84|-0.32|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715524|NCT00770315|3156653|Superiority or Other||Mean Difference (Final Values)|-0.51||||0.19|2-Sided|95.0|-1.26|0.25|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715525|NCT00770315|3156654|Superiority or Other||Mean Difference (Final Values)|-0.96||||0.0021|2-Sided|95.0|-1.57|-0.35|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715526|NCT00770315|3156654|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.1914|2-Sided|95.0|-0.99|0.2|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715527|NCT00770315|3156654|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.2622|2-Sided|95.0|-0.93|0.25|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715528|NCT00770315|3156655|Superiority or Other||Mean Difference (Final Values)|-0.94||||0.0118|2-Sided|95.0|-1.67|-0.21|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715529|NCT00770315|3156655|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.1695|2-Sided|95.0|-1.21|0.21|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715530|NCT00770315|3156655|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.4781|2-Sided|95.0|-0.96|0.45|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715531|NCT00770315|3156656|Superiority or Other||Mean Difference (Final Values)|-1.92||||0.0003|2-Sided|95.0|-2.95|-0.88|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715532|NCT00770315|3156656|Superiority or Other||Mean Difference (Final Values)|-1.28||||0.0125|2-Sided|95.0|-2.29|-0.28|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715533|NCT00770315|3156656|Superiority or Other||Mean Difference (Final Values)|-0.88||||0.0878|2-Sided|95.0|-1.88|0.13|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715534|NCT00770315|3156657|Superiority or Other||Mean Difference (Final Values)|-2.04||||0.0015|2-Sided|95.0|-3.3|-0.79|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715535|NCT00770315|3156657|Superiority or Other||Mean Difference (Final Values)|-1.58||||0.0113|2-Sided|95.0|-2.8|-0.36|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715536|NCT00770315|3156657|Superiority or Other||Mean Difference (Final Values)|-0.76||||0.2192|2-Sided|95.0|-1.98|0.45|||ANOVA||ANOVA model with baseline asthmatic condition, pollen region and treatment group as fixed effects||
1715537|NCT00770289|3156659|Superiority or Other||Pearson's correlation coefficient|0.765|||<|0.0001|2-Sided|95.0|0.736|0.791||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson’s correlation coefficient was used to evaluate compatibility between the questionnaires.|
1715538|NCT00770289|3156659|Superiority or Other||Pearson's correlation coefficient|0.797|||<|0.0001|2-Sided|95.0|0.771|0.82||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.|
1715539|NCT00770289|3156659|Superiority or Other||Pearson's correlation coefficient|0.899|||<|0.0001|2-Sided|95.0|0.886|0.911||The statistical testing was done at alpha = 0.05.|Pearson's correlation|||Change from baseline at Week 12: Pearson's correlation coefficient was used to evaluate compatibility between the questionnaires.|
1715540|NCT00770211|3156671|Superiority or Other||Difference response rate|0.48|Standard Error of the Mean|0.037|<|0.0001|2-Sided|95.0|0.4|0.56|||Fisher Exact|||The efficacy of the treatment was confirmed, if H0 was rejected at a given alpha of 5%, that means if the two sided p-value is ≤ 0.05. Power of 90%|
1715541|NCT00770146|3156673|Superiority or Other|||||||0.032||||||No adjustments were made for tertiary parameters.|t-test, 2 sided||||
1715542|NCT00770146|3156675|Superiority or Other||||||<|0.001||||||No adjustments were made for tertiary parameters.|t-test, 2 sided||||
1715543|NCT00770146|3156677|Superiority or Other||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)||||
1715544|NCT00770146|3156679|Superiority or Other||||||<|0.001||||||No adjustments were made for tertiary parameters.|t-test, 2 sided||||
1715545|NCT00770146|3156681|Superiority or Other|||||||0.977||||||No adjustments were made for tertiary parameters.|t-test, 2 sided||||
1715546|NCT00770146|3156683|Superiority or Other||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)||||
1715547|NCT00770146|3156685|Superiority or Other||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon (Mann-Whitney)||||
1715548|NCT00770146|3156687|Superiority or Other||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided||||
1715549|NCT00770146|3156689|Superiority or Other||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon (Mann-Whitney)||||
1715550|NCT00770146|3156691|Superiority or Other||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|Wilcoxon (Mann-Whitney)|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With at least 20 patients in the control group and 40 patients in the mipomersen-treated group, this study would have at least 90% power to detect a 20% difference between the 2 groups.|
1715551|NCT00770029|3156700|Superiority or Other||Difference response rate|0.6|Standard Error of the Mean|0.036|<|0.0001|2-Sided|95.0|0.52|0.68|||Fisher Exact|||The efficacy of the treatment was confirmed if H0 was rejected at a given α of 5%, that means if the two sided p-value was ≤0.05. Power of 90%|
1715552|NCT00769704|3156712|Superiority or Other||Hazard Ratio (HR)|0.3||||0.005|2-Sided|95.0|0.13|0.73||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio < 1.0 indicates a longer response interval for talimogene laherparepvec relative to GM-CSF.||
1715553|NCT00769704|3156713|Superiority or Other||Hazard Ratio (HR)|0.42|||<|0.0001|2-Sided|95.0|0.32|0.54||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio < 1.0 indicates a longer average time to treatment failure for talimogene laherparepvec relative to GM-CSF.||
1715554|NCT00769704|3156714|Superiority or Other||Hazard Ratio (HR)|0.62||||0.202|2-Sided|95.0|0.3|1.3||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio > 1.0 indicates a a higher average response onset rate for talimogene laherparepvec relative to GM-CSF.||
1715555|NCT00769704|3156715|Superiority or Other||Hazard Ratio (HR)|0.4||||0.0868|2-Sided|95.0|0.14|1.18||Descriptive|Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio < 1.0 indicates a longer average duration of response for talimogene laherparepvec relative to GM-CSF.||
1715556|NCT00769704|3156716|Superiority or Other||Treatment Difference|20.8|||<|0.0001|2-Sided|95.0|14.4|27.1||Descriptive|Fisher Exact||||
1715557|NCT00769704|3156717|Superiority or Other||Hazard Ratio (HR)|0.79||||0.0511|2-Sided|95.0|0.62|1.0|||Log Rank||The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio < 1.0 indicates a lower average death rate and a longer overall survival for talimogene laherparepvec relative to GM-CSF.|The primary method for analysis of overall survival was an unadjusted log-rank test. Testing of overall survival was conditional on a statistically significance difference in the primary endpoint of durable response. Success was defined as a p-value ≤ 0.05.|
1715558|NCT00769704|3156718|Superiority or Other||Treatment Difference|14.1|||<|0.0001|2-Sided|95.0|9.3|19.0|||Fisher Exact|||The null hypothesis was that there was no difference in the durable response rate between the talimogene laherparepvec and control arms. Study success was defined as the rejection of this hypothesis such that talimogene laherparepvec was found to be superior to GM-CSF using the 2-sided Fisher’s exact test, with a p-value of ≤ 0.0488.|
1715559|NCT00769392|3156742|Other|||||||0.17|||||||single factor analysis of variance|||A comparison of discomfort of all 4 anesthesia intervention agents used in this study using mean pain scores.|
1715560|NCT00769392|3156743|Other|||||||0.28|||||||single factor analysis of variance|||A comparison of injection discomfort using mean pain scores for all 4 anesthesia intervention agents used in this study.|
1715561|NCT00769314|3156745|Superiority or Other|||||||0.0022||||||p-value < 0.05 considered significant|Chi-squared||||
1715562|NCT00769314|3156746|Superiority or Other|||||||0.6045||||||p-value < 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 14 timepoint|
1715563|NCT00769314|3156746|Superiority or Other|||||||0.3303||||||p-value < 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 7 timepoint|
1715564|NCT00769314|3156746|Superiority or Other|||||||0.0078||||||p-value < 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at the Day 5 timepoint|
1715565|NCT00769314|3156746|Superiority or Other|||||||0.1824||||||p-value < 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at Day 3 timepoint|
1715566|NCT00769314|3156746|Superiority or Other|||||||0.5695||||||p-value < 0.05 considered significant|Wilcoxon (Mann-Whitney)|||Analysis conducted between treatment groups at Day 1 timepoint.|
1715567|NCT00769314|3156747|Superiority or Other|||||||0.0271||||||p-value < 0.05 considered significant|Chi-squared||||
1715568|NCT00769314|3156748|Superiority or Other|||||||0.0412||||||p-value < 0.05 considered significant|Log Rank||||
1715569|NCT00769314|3156749|Superiority or Other|||||||0.015||||||p-value < 0.05 considered significant|Log Rank||||
1715570|NCT00769314|3156750|Superiority or Other|||||||0.8005||||||p-value < 0.05 considered significant|Log Rank||||
1715571|NCT00769314|3156751|Superiority or Other|||||||0.0098||||||p-value < 0.05 considered significant|Log Rank||||
1715572|NCT00769314|3156752|Superiority or Other|||||||0.0033||||||p-value < 0.05 considered significant|Log Rank||||
1715573|NCT00769314|3156753|Superiority or Other|||||||0.0683||||||p-value < 0.05 considered significant|Log Rank||||
1715574|NCT00769314|3156754|Superiority or Other||Treatment difference|0.0685||||0.0419|2-Sided|95.0|0.0025|0.1339||p-value < 0.05 considered significant|Chi-squared||Treatment difference was the proportion of patients with aborted lesions in the acyclovir Lauriad group minus the proportion of patients with aborted lesions in the placebo group.||
1715575|NCT00769132|3156757|Superiority or Other (legacy)||Geometric least-squares mean ratio|0.64||||||90.0|0.57|0.72|||||||
1715576|NCT00769132|3156757|Superiority or Other (legacy)||Geometric least-squares mean ratio|0.62||||||90.0|0.55|0.7|||||||
1715577|NCT00769132|3156757|Superiority or Other (legacy)||Geometric least-squares mean ratio|0.58||||||90.0|0.51|0.65|||||||
1715578|NCT00769132|3156757|Superiority or Other (legacy)||Geometric least-squares mean ratio|0.56||||||90.0|0.49|0.63|||||||
1715579|NCT00769132|3156757|Superiority or Other (legacy)||Geometric least-squares mean ratio|0.9||||||90.0|0.8|1.01|||||||
1715580|NCT00769132|3156757|Superiority or Other (legacy)||Geometric least-squares mean ratio|1.04||||||90.0|0.92|1.17|||||||
1715581|NCT00769132|3156758|Superiority or Other (legacy)||Geometric least-squares mean ratio|1.02||||||90.0|0.83|1.25|||||||
1715582|NCT00769132|3156758|Superiority or Other (legacy)||Geometric least-squares mean ratio|0.91||||||90.0|0.74|1.12|||||||
1715583|NCT00769132|3156758|Superiority or Other (legacy)||Geometric least-squares mean ratio|0.89||||||90.0|0.72|1.09|||||||
1715584|NCT00769132|3156758|Superiority or Other (legacy)||Geometric least-squares mean ratio|0.8||||||90.0|0.65|0.98|||||||
1715585|NCT00769132|3156758|Superiority or Other (legacy)||Geometric least-squares mean ratio|0.87||||||90.0|0.71|1.07|||||||
1715586|NCT00769132|3156758|Non-Inferiority or Equivalence (legacy)|Two treatments are comparable if the geometric mean ratio is contained within the interval [0.50-2.00].|Geometric least-squares mean ratio|1.12||||||90.0|0.9|1.38||||||The endpoint is the urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. The point estimate and 90% confidence intervals (CIs) were calculated for the geometric mean ratio (GMR) [Treatment A/B] of the urine levels of 11-dTxB2 on Day 7.|
1715587|NCT00769067|3156779|Superiority or Other||Hazard Ratio (HR)|0.822||||0.252|2-Sided|95.0|0.587|1.151||2-Sided.|Log Rank|Adjusted by stratification factors: EGFR status, KRAS status and baseline ECOG performance status.|The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.|HR and its 95% confidence interval were estimated from stratified Cox Regression and 2-sided p-value was based on the stratified log-rank test with EGFR status, KRAS status and baseline ECOG as stratification factors.|
1715588|NCT00769067|3156782|Superiority or Other|||||||0.011||||||2-Sided.|Chi-squared|Unadjusted.|||
1715589|NCT00769067|3156783|Superiority or Other||Hazard Ratio (HR)|0.657||||0.012|2-Sided|95.0|0.472|0.914||2-Sided.|Log Rank|Adjusted for the stratification factors: EGFR status, KRAS status and baseline ECOG performance status.|The estimated HR was for the Dacomitinib arm versus the Erlotinib arm.|"Total 128 events (progression/death) provided 80% power to detect a hazard ratio (HR) of 1.45 (Erlotinib versus Dacomitinib arm) with 1-sided alpha=0.10.This represented a 45% improvement in true median PFS.~HR and 95% confidence interval estimated from stratified Cox Regression;2-sided p-value was based on stratified log-rank test with epidermal growth factor receptor (EGFR) status, Kirsten Rat Sarcoma status (KRAS), baseline Eastern Cooperative Oncology Group (ECOG) as stratification factors"|
1715590|NCT00769015|3156790|Superiority or Other||Mean Difference (Final Values)|1.62||||0.68|2-Sided|95.0|-5.94|9.17|||Least squares mean||||
1715591|NCT00769015|3156791|Superiority or Other||Mean Difference (Final Values)|1.39||||0.68|2-Sided|95.0|-4.04|6.82|||Least squares mean||||
1715592|NCT00769015|3156792|Superiority or Other||Mean Difference (Final Values)|-2.02||||0.68|2-Sided|95.0|-9.8|5.76|||Least squares mean||||
1715593|NCT00769015|3156793|Superiority or Other||Mean Difference (Final Values)|2.42||||0.34|2-Sided|95.0|-2.58|7.41|||Least squares mean||||
1715594|NCT00769015|3156794|Superiority or Other||Change in least squares mean|3.47||||0.68|2-Sided|95.0|-12.22|5.29|||Mixed Models Analysis||||
1715595|NCT00769015|3156795|Superiority or Other||Mean Difference (Net)|-0.81||||0.75|2-Sided|95.0|-5.92|4.3|||Linear Mixed effects model||||
1715596|NCT00769015|3156796|Superiority or Other||Risk Ratio (RR)|0.54||||0.067|2-Sided|95.0|0.27|1.06||Mantel-Haenszel chi-square test. The p-value refers to the overall test of between group differences in rates of depression.|Mantel Haenszel||||
1715597|NCT00768755|3156834|Superiority or Other||Risk Ratio (RR)|1.512||||0.0665|2-Sided|95.0|0.87|2.626|||Cochran-Mantel-Haenszel|||P-value was calculated using CMH test stratified by ECOG performance status (0 or 1) and gender (male or female).|
1715598|NCT00768755|3156834|Superiority or Other||Risk Ratio (RR)|1.753||||0.0143|2-Sided|95.0|1.047|2.935|||Cochran-Mantel-Haenszel|||P-value was calculated using Cochran-Mantel-Haenszel (CMH) test stratified by ECOG performance status (0 or 1) and gender (male or female).|
1715599|NCT00768755|3156835|Superiority or Other||Hazard Ratio (HR)|1.449||||0.9392|2-Sided|95.0|0.919|2.285|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.|
1715600|NCT00768755|3156835|Superiority or Other||Hazard Ratio (HR)|1.046||||0.5785|2-Sided|95.0|0.648|1.69|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.|
1715601|NCT00768755|3156836|Superiority or Other||Hazard Ratio (HR)|0.947||||0.3565|2-Sided|95.0|0.58|1.546|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by ECOG performance status (0 or 1) and gender (male or female). HR: the stratified Cox model was fitted, using the same stratification variables as above.|
1715625|NCT00768261|3156909|Other|||||||0.009|||||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."|
1715892|NCT00764478|3157485|Superiority or Other|||||||0.02|||||||Cochran-Mantel-Haenszel|||Day 7|
1715602|NCT00768755|3156836|Superiority or Other||Hazard Ratio (HR)|0.831||||0.3037|2-Sided|95.0|0.508|1.36|||Log Rank|One-sided log-rank test at alpha = 0.20 significance level was used.||P-value was calculated using 1-sided log rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1) and gender (male or female). Hazard ratio (HR): the stratified Cox model was fitted, using the same stratification variables as above.|
1715603|NCT00768716|3156837|Other|||||||0.003|||||||ANOVA||||
1715604|NCT00768716|3156838|Other||||||<|0.0001|||||||ANOVA||||
1715605|NCT00768716|3156839|Other||||||<|0.0001|||||||ANOVA||||
1715606|NCT00768716|3156841|Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)||||
1715607|NCT00768716|3156842|Other|||||||0.42|||||||Wilcoxon (Mann-Whitney)||||
1715608|NCT00768716|3156843|Other|||||||0.52|||||||Wilcoxon (Mann-Whitney)||||
1715609|NCT00768651|3156865|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||The sample size of 8 was determined to provide a 95% confidence interval expected width of 0.62 for the proportion of subjects who become insulin independent with treatment. Four of eight subjects (50%) would have to achieve insulin independence in order to reject the null hypothesis with 85% power and one sided alpha of 0.025. Statistical significance was set at 5%. Mean values were computed using Student's t-test while medians were compared using Wilcoxon's test.|
1715610|NCT00768560|3156878|Superiority or Other||Mean Difference (Final Values)|3.29||||||90.0|1.76|4.82|||||80 mg OD minus 40 mg BID|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.|
1715611|NCT00768560|3156878|Superiority or Other||Mean Difference (Final Values)|-0.68||||||90.0|-2.21|0.85|||||80 mg OD minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.|
1715612|NCT00768560|3156878|Superiority or Other||Mean Difference (Final Values)|-3.97||||||90.0|-5.5|-2.44|||||40 mg BID minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in DBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.|
1715613|NCT00768560|3156878|Superiority or Other||Mean Difference (Final Values)|9.75||||||90.0|6.83|12.67|||||80 mg OD minus 40 mg BID|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.|
1715614|NCT00768560|3156878|Superiority or Other||Mean Difference (Final Values)|0.06||||||90.0|-2.87|2.98|||||80 mg OD minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the ANOVA model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.|
1715615|NCT00768560|3156878|Superiority or Other||Mean Difference (Final Values)|-9.69||||||90.0|-12.62|-6.77|||||40 mg BID minus 40 mg OD|The point estimate and 90% confidence interval of the difference of changes in SBP from baseline was estimated by using the analysis of variance (ANOVA) model including the terms: group, subject within a group, dosage and administration and stage as fixed effects.|
1715616|NCT00768521|3156879|Superiority or Other||Mean Difference (Final Values)|1.63||||0.422||90.0|-11.5|16.71||1-sided, alpha = 0.05|ANCOVA|Baseline used as covariate.|||
1715617|NCT00768521|3156880|Superiority or Other||Mean Difference (Final Values)|23.18||||0.008||90.0|7.58|41.06||1-sided, alpha = 0.05|ANCOVA|Baseline used as covariate.|Primary Hypothesis: Tolterodine LA 4 mg is superior to placebo with respect to change from baseline in maximum cystometric capacity at 4 hours post Dose 7 (i.e., steady state). The expected treatment effect is targeted at 40 mL.||
1715618|NCT00768300|3156888|Superiority or Other||Point estimate|0.5||||0.793|2-Sided|95.0|0.0|1.0||The p-value was based on a Wilcoxon rank sum test stratified by baseline pulmonary hypertension (Yes/No) and surgical lung biopsy was performed with definite or probable UIP based on core pathology review (Yes/No).|Wilcoxon (Mann-Whitney)||The point estimate and 95% confidence interval were based on the Hodges-Lehmann Estimate of treatment effect||
1715619|NCT00768300|3156891|Superiority or Other||Point estimate|16.0||||0.15|2-Sided|95.0|-5.0|37.0||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.||
1715620|NCT00768300|3156892|Superiority or Other||Point estimate|2.85||||0.25|2-Sided|95.0|-2.2|7.9||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and its 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.||
1715621|NCT00768300|3156893|Superiority or Other||Point estimate|4.29||||0.086|2-Sided|95.0|-0.805|9.376||P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.|Van Elteren test||The point estimate and 95% confidence interval (CI) were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.||
1715622|NCT00768300|3156895|Superiority or Other||Hazard Ratio (HR)|1.74||||0.01|2-Sided|95.0|1.14|2.66||P-value was based on a stratified log-rank test with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable usual interstitial pneumonia (UIP) based on core pathology review.|Log Rank||The hazard ratio was based on a stratified Cox proportional hazards model with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable UIP based on core pathology review.||
1715623|NCT00768261|3156909|Other|||||||0.0288|||||||Repeated Measures ANOVA|||RM-ANOVA on hippocampal volume slope|
1715624|NCT00768261|3156909|Other|||||||0.3|||||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."|
1715797|NCT00764868|3157420|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test of LDX at baseline and 52 weeks|||
1715626|NCT00768261|3156909|Other|||||||0.066|||||||ANOVA|||"There would be a treatment effect on the changes of hippocampal measures over time.~Repeated measures ANOVA on hippocampal volume slopes with hemisphere as a within-subject repeated factor, and treatment group as the main effect."|
1715627|NCT00768261|3156910|Other|||||||0.095|||||||ANOVA|df= 3,92|||
1715628|NCT00768053|3156954|Superiority or Other||||||<|0.001|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Coping NRS value|
1715629|NCT00768053|3156954|Superiority or Other||||||<|0.043|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value|
1715630|NCT00768053|3156954|Superiority or Other||||||<|0.029|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value|
1715631|NCT00768053|3156954|Superiority or Other||||||<|0.153|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Sleep NRS value|
1715632|NCT00768053|3156954|Superiority or Other||||||<|0.895|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value|
1715633|NCT00768053|3156954|Superiority or Other||||||<|0.052|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value|
1715634|NCT00768053|3156954|Superiority or Other||||||<|0.001|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Pain NRS value|
1715635|NCT00768053|3156955|Superiority or Other||||||<|0.001|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Coping NRS value|
1715636|NCT00768053|3156955|Superiority or Other||||||<|0.025|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Emotional well-being NRS value|
1715637|NCT00768053|3156955|Superiority or Other||||||<|0.351|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Physical well-being NRS value|
1715638|NCT00768053|3156955|Superiority or Other||||||<|0.035|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Sleep NRS value|
1715639|NCT00768053|3156955|Superiority or Other||||||<|0.837|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Fatigue NRS value|
1715640|NCT00768053|3156955|Superiority or Other||||||<|0.001|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Functional disability NRS value|
1715641|NCT00768053|3156955|Superiority or Other||||||<|0.001|||||||paired t-test|A non significant test (p-value ≥ 0.05) would indicate the component had a significant influence to the global EULAR-RAID score.||Comparison of change from baseline between EULAR-RAID score and Pain NRS value|
1715642|NCT00768053|3156956|Superiority or Other||||||<|0.001|||||||t-test for the Pearson correlation|||Time-normalized average|
1715643|NCT00768053|3156957|Superiority or Other||||||<|0.001|||||||t-test for the Pearson correlation|||Week 12|
1715644|NCT00768053|3156958|Superiority or Other||||||<|0.001|||||||t-test for the Pearson correlation|||Week 4|
1715645|NCT00768053|3156959|Superiority or Other||||||<|0.001|||||||t-test for the Pearson correlation|||Time-normalized average|
1715646|NCT00768053|3156960|Superiority or Other||||||<|0.001|||||||t-test for the Pearson correlation|||Week 12|
1715647|NCT00768053|3156961|Superiority or Other||||||<|0.001|||||||t-test for the Pearson correlation|||Week 4|
1715648|NCT00768053|3156963|Superiority or Other||standard error of measurement|0.65|||||2-Sided|95.0|0.57|0.75||||||Standardized response mean: standard error of measurement|
1715649|NCT00768053|3156963|Superiority or Other|||||||0||||||F test for H0: ICC = 0|F test|||Intraclass correlation coefficient (ICC)|
1715650|NCT00767819|3156970|Superiority|The lower limit of the confidence interval was used to support the decision in favor of p0 or p1: if the lower limit of the confidence interval overlapped p0, the hypothesis that p is greater than or equal to p1 could be rejected; on the other side, if the lower limit of the confidence interval excluded p0, the hypothesis that p is greater than or equal to p1 could be accepted.|percentage of participants|40.5||||0.1|2-Sided|80.0|29.5|52.4|||Clopper-Person confidence interval||||
1715651|NCT00767806|3156972|Superiority or Other|||||||0.68||||||p-value is for difference between duloxetine and placebo in pulse rate - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of pulse rate during 12 weeks of treatment.|
1715652|NCT00767806|3156974|Superiority or Other|||||||0.562||||||p-value is for difference between placebo and duloxetine groups in change of diastolic blood pressure|ANOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of diastolic blood pressure during 12 weeks of treatment.|
1715725|NCT00767039|3157044|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).|
1715653|NCT00767806|3156974|Superiority or Other|||||||0.329||||||p-value is for difference between placebo and duloxetine groups in change of systolic blood pressure|ANOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of systolic blood pressure during 12 weeks of treatment.|
1715654|NCT00767806|3156975|Superiority or Other|||||||0.019||||||p-value is for difference between duloxetine and placebo in total protein - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of total protein during 12 weeks of treatment.|
1715655|NCT00767806|3156976|Superiority or Other|||||||0.024||||||p-value is for difference between duloxetine and placebo in creatinine - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of creatinine during 12 weeks of treatment.|
1715656|NCT00767806|3156977|Superiority or Other|||||||0.039||||||p-value for difference between duloxetine and placebo in aspartate aminotransferase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of aspartate aminotransferase during 12 weeks of treatment.|
1715657|NCT00767806|3156978|Superiority or Other|||||||0.013||||||p-value is for difference between duloxetine and placebo in alanine aminotransferase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Alanine Aminotransferase during 12 weeks of treatment.|
1715658|NCT00767806|3156979|Superiority or Other|||||||0.004||||||p-value is for difference between duloxetine and placebo in alkaline phosphatase - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of alkaline phosphatase during 12 weeks of treatment.|
1715659|NCT00767806|3156980|Superiority or Other|||||||0.031||||||p-value is for difference between duloxetine and placebo in albumin - change|ANOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of Albumin during 12 weeks of treatment.|
1715660|NCT00767806|3156981|Superiority or Other|||||||0.01||||||p-value is for difference between placebo and duloxetine groups in uric acid - change|ANOVA|Change Variable = Treatment + Investigator (Type III sums of squares). Rank-transformed change was used as change variable in the ANOVA model.||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of uric acid during 12 weeks of treatment.|
1715661|NCT00767806|3156983|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.007|2-Sided|95.0|-0.1|-0.02||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Activity Impairment score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Activity Impairment score during 12 weeks of treatment.|
1715662|NCT00767806|3156983|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.557|2-Sided|95.0|-0.09|0.05||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Work Productivity Loss score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Work Productivity Loss score during 12 weeks of treatment.|
1715663|NCT00767806|3156983|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.374|2-Sided|95.0|-0.09|0.03||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Presenteeism score|ANCOVA|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Presenteeism score during 12 weeks of treatment.|
1715664|NCT00767806|3156983|Superiority or Other||Mean Difference (Final Values)|0.02||||0.461|2-Sided|95.0|-0.03|0.06||p-value is for difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Absenteeism score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Work Productivity and Activity Impairment Instrument (WPAI) - Absenteeism score during 12 weeks of treatment.|
1715665|NCT00767806|3156984|Superiority or Other||Mean Difference (Final Values)|0.05||||0.002|2-Sided|95.0|0.02|0.08||p-value is for difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United States population-based index score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United States population-based index score during 12 weeks of treatment.|
1715666|NCT00767806|3156984|Superiority or Other||Mean Difference (Final Values)|0.07|||<|0.001|2-Sided|95.0|0.03|0.12||p-value is for difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United Kingdom population-based Index score|ANCOVA|Main Effect Model: Change = Treatment + Investigator (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the European Quality of Life Questionnaire - 5 Dimension - United Kingdom population-based Index score during 12 weeks of treatment.|
1715667|NCT00767806|3156985|Superiority or Other||Mean Difference (Final Values)|4.1||||0.022|2-Sided|95.0|0.59|7.6||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Vitality Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Vitality Transformed score during 12 weeks of treatment.|
1715668|NCT00767806|3156985|Superiority or Other||Mean Difference (Final Values)|4.0||||0.03|2-Sided|95.0|0.38|7.61||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Social Functioning Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Social Functioning Transformed score during 12 weeks of treatment.|
1715726|NCT00767039|3157045|Superiority or Other||Risk Ratio (RR)|0.43|||<|0.05|2-Sided|95.0|0.19|0.95|||Mantel Haenszel||||
1715669|NCT00767806|3156985|Superiority or Other||Mean Difference (Final Values)|1.91||||0.383|2-Sided|95.0|-2.39|6.21||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Physical Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Physical Transformed score during 12 weeks of treatment.|
1715670|NCT00767806|3156985|Superiority or Other||Mean Difference (Final Values)|2.43||||0.227|2-Sided|95.0|-1.52|6.37||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Emotional Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Role-Emotional Transformed score during 12 weeks of treatment.|
1715671|NCT00767806|3156985|Superiority or Other||Mean Difference (Final Values)|3.5||||0.058|2-Sided|95.0|-0.12|7.12||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Physical Functioning Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Physical Functioning Transformed score during 12 weeks of treatment.|
1715672|NCT00767806|3156985|Superiority or Other||Mean Difference (Final Values)|2.58||||0.101|2-Sided|95.0|-0.5|5.67||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey General Health Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey General Health Transformed score during 12 weeks of treatment.|
1715673|NCT00767806|3156985|Superiority or Other||Mean Difference (Final Values)|4.88|||<|0.001|2-Sided|95.0|2.15|7.61||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Health Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Health Transformed score during 12 weeks of treatment.|
1715674|NCT00767806|3156985|Superiority or Other||Mean Difference (Final Values)|4.58|||<|0.016|2-Sided|95.0|0.86|8.3||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Bodily Pain Transformed score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Bodily Pain Transformed score during 12 weeks of treatment.|
1715675|NCT00767806|3156985|Superiority or Other||Mean Difference (Final Values)|2.24|||<|0.01|2-Sided|95.0|0.53|3.96||p-value is for difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Component score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the SF-36 Health Survey Mental Component score during 12 weeks of treatment.|
1715676|NCT00767806|3156985|Superiority or Other||Mean Difference (Final Values)|1.24|||<|0.168|2-Sided|95.0|-0.53|3.02||p-value is for difference between placebo and duloxetine groups in change of the 36-SF Health Survey Physical Component score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the 36-SF Health Survey Physical Component score during 12 weeks of treatment.|
1715677|NCT00767806|3156986|Superiority or Other||Mean Difference (Final Values)|-4.0||||0.001|2-Sided|95.0|-6.41|-1.6||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Total Mood Disturbance score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Total Mood Disturbance score during 12 weeks of treatment.|
1715678|NCT00767806|3156986|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.006|2-Sided|95.0|-0.98|-0.17||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Confusion-Bewilderment score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Confusion-Bewilderment score during 12 weeks of treatment.|
1715679|NCT00767806|3156986|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.469|2-Sided|95.0|-0.93|0.43||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Fatigue-Inertia score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Fatigue-Inertia score during 12 weeks of treatment.|
1715680|NCT00767806|3156986|Superiority or Other||Mean Difference (Final Values)|1.13||||0.003|2-Sided|95.0|0.38|1.88||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Vigor-Activity score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Vigor-Activity score during 12 weeks of treatment.|
1715681|NCT00767806|3156986|Superiority or Other||Mean Difference (Final Values)|-0.92|||<|0.001|2-Sided|95.0|-1.46|-0.37||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Anger-Hostility score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Anger-Hostility score during 12 weeks of treatment.|
1715757|NCT00766090|3157163|Superiority or Other||Mean Difference (Final Values)|0.108|||<|0.001|2-Sided|95.0|0.064|0.153|||ANCOVA||||
1715798|NCT00764868|3157422|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test of LDX at baseline and 52 weeks|||
1715799|NCT00764751|3157439|Superiority||Mean Difference (Final Values)|-17.1||||0.07|2-Sided|95.0|-36.0|1.9|||Paired t-test||||
1715682|NCT00767806|3156986|Superiority or Other||Mean Difference (Final Values)|-0.39|||<|0.133|2-Sided|95.0|-0.9|0.12||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Depression-Dejection subscore|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Depression-Dejection subscore during 12 weeks of treatment.|
1715683|NCT00767806|3156986|Superiority or Other||Mean Difference (Final Values)|-0.88|||<|0.001|2-Sided|95.0|-1.38|-0.37||p-value is for difference between placebo and duloxetine groups in change of the Profile of Mood States Tension-Anxiety subscore|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Profile of Mood States Tension-Anxiety subscore during 12 weeks of treatment.|
1715684|NCT00767806|3156987|Superiority or Other||Mean Difference (Final Values)|-0.47||||0.255|2-Sided|95.0|-1.28|0.34||p-value is for difference between placebo and duloxetine groups in change of the Roland Morris Disability Questionnaire total score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Roland Morris Disability Questionnaire total score during 12 weeks of treatment.|
1715685|NCT00767806|3156988|Superiority or Other||Mean Difference (Final Values)|-0.31||||0.011|2-Sided|95.0|-0.56|-0.07||p-value is for difference between placebo and duloxetine groups Patient's Global Impression of Improvement endpoint value|ANCOVA|Main Effect Model: PGI-I=Treatment+Investigator+Baseline(Type III sums of squares). PGI-Severity score from baseline visit was used as the baseline.||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups Patient's Global Impression of Improvement endpoint value during 12 weeks of treatment.|
1715686|NCT00767806|3156989|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.077|2-Sided|95.0|-0.33|0.02||p-value is for difference between placebo and duloxetine groups in change of the Clinical Global Impression of Severity score|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Clinical Global Impression of Severity score after 12 weeks of treatment.|
1715687|NCT00767806|3156990|Superiority or Other|||||||0.013||||||p-value is for difference between duloxetine and placebo groups in the empirical overall cumulated distribution of the percentage pain reduction|Kolnogorov-Smirnov test|||Tested was the null hypothesis that there is no difference between duloxetine and placebo groups in the empirical cumulated distribution of the percentage pain reduction.|
1715688|NCT00767806|3156991|Superiority or Other|||||||0.082||||||p-value is difference between duloxetine and placebo in number of patients who achieve criteria described in null hypothesis|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a >=30% reduction of the Brief Pain Inventory (BPI) average pain severity rating from baseline to endpoint and baseline to earlier visit than last visit and maintains a >=20% reduction of BPI average pain rating from baseline at every visit.|
1715689|NCT00767806|3156992|Superiority or Other|||||||0.006||||||p-value is for number of patients who achieve a >=50% reduction of the Brief Pain Inventory average pain severity rating - difference between placebo and duloxetine|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a >=50% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.|
1715690|NCT00767806|3156993|Superiority or Other|||||||0.108||||||p-value is for number of patients who achieve a >=30% reduction of the Brief Pain Inventory average pain severity rating - difference between placebo and duloxetine|Fisher Exact|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in number of patients who achieve a >=30% reduction of the Brief Pain Inventory average pain severity rating after 12 weeks of treatment.|
1715691|NCT00767806|3156994|Superiority or Other||Mean Difference (Final Values)|-0.52||||0.004|2-Sided|95.0|-0.87|-0.17||p-value is for weekly 24-hour night pain score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour night pain score during 12 weeks of treatment.|
1715692|NCT00767806|3156994|Superiority or Other||Mean Difference (Final Values)|-0.71|||<|0.001|2-Sided|95.0|-1.08|-0.33||p-value is for weekly 24-hour worst pain score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour worst pain score during 12 weeks of treatment.|
1715693|NCT00767806|3156994|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.001|2-Sided|95.0|-1.05|-0.35||p-value is for weekly 24-hour average pain rating score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the weekly 24-hour average pain rating score during 12 weeks of treatment.|
1715694|NCT00767806|3156995|Superiority or Other||Mean Difference (Final Values)|-0.58|||<|0.001|2-Sided|95.0|-0.92|-0.25||P-value is for BPI average interference score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory average interference score during 12 weeks of treatment.|
1715695|NCT00767806|3156995|Superiority or Other||Mean Difference (Final Values)|-0.57|||<|0.005|2-Sided|95.0|-0.96|-0.18||P-value is for BPI interference with enjoyment of life score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with enjoyment of life score during 12 weeks of treatment.|
1715696|NCT00767806|3156995|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.002|2-Sided|95.0|-1.13|-0.27||P-value is for BPI interference with sleep score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with sleep score during 12 weeks of treatment.|
1715697|NCT00767806|3156995|Superiority or Other||Mean Difference (Final Values)|-0.57|||<|0.001|2-Sided|95.0|-0.92|-0.22||P-value is for BPI interference with relations to others - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with relations to others score during 12 weeks of treatment.|
1715698|NCT00767806|3156995|Superiority or Other||Mean Difference (Final Values)|-0.51|||<|0.012|2-Sided|95.0|-0.9|-0.11||P-value is for BPI interference with normal work - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with normal work score during 12 weeks of treatment.|
1715699|NCT00767806|3156995|Superiority or Other||Mean Difference (Final Values)|-0.46|||<|0.02|2-Sided|95.0|-0.84|-0.07||P-value is for BPI interference with walking ability - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with walking ability score during 12 weeks of treatment.|
1715700|NCT00767806|3156995|Superiority or Other||Mean Difference (Final Values)|-0.71|||<|0.001|2-Sided|95.0|-1.09|-0.34||P-value is for BPI interference with mood score - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with mood score during 12 weeks of treatment.|
1715701|NCT00767806|3156995|Superiority or Other||Mean Difference (Final Values)|-0.75|||<|0.001|2-Sided|95.0|-1.16|-0.35||P-value is for BPI interference with general activity - change|ANCOVA|Main Effect Model: Change = Treatment + Investigator + Baseline (Type III sums of squares)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory interference with general activity score during 12 weeks of treatment.|
1715702|NCT00767806|3156995|Superiority or Other||Mean Difference (Final Values)|-0.86|||<|0.001|2-Sided|95.0|-1.25|-0.46||P-value is for BPI severity of pain right now - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of pain right now score during 12 weeks of treatment.|
1715703|NCT00767806|3156995|Superiority or Other||Mean Difference (Final Values)|-0.49|||<|0.006|2-Sided|95.0|-0.85|-0.14||P-value is for BPI severity of least pain - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of least pain score during 12 weeks of treatment.|
1715704|NCT00767806|3156995|Superiority or Other||Mean Difference (Final Values)|-0.68|||<|0.002|2-Sided|95.0|-1.12|-0.25||P-value is for BPI severity of worst pain - change|ANCOVA|Main effect model: Change = Treatment + Investigator + Baseline (Type III sums of square)||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory severity of worst pain score during 12 weeks of treatment.|
1715705|NCT00767806|3156996|Superiority or Other|||||||0.001|||||||Mixed Models Analysis|||Tested was the null hypothesis that there is no difference between placebo and duloxetine groups in change of the Brief Pain Inventory 24-hour average pain score after 12 weeks of treatment.|
1715706|NCT00767572|3157001|Superiority or Other||||||>|0.05||||||Significance threshold p<0.05|t-test, 2 sided|||Null hypothesis: pre-post brachial artery diameter changes do not differ between placebo and atorvastatin|
1715707|NCT00767520|3157017|Superiority or Other||Hazard Ratio (HR)|0.82||||0.148|||||||Un-stratified log-rank test||||
1715708|NCT00767325|3157033|Superiority or Other||Mean Difference (Final Values)|-4.8|Standard Error of the Mean|0.473|||2-Sided|95.0|-5.8|-3.9|||||Day 169||
1715709|NCT00767325|3157033|Superiority or Other||Mean Difference (Final Values)|-4.8|Standard Error of the Mean|0.492|||2-Sided|95.0|-5.8|-3.8|||||Day 141||
1715710|NCT00767325|3157033|Superiority or Other||Mean Difference (Final Values)|-4.5|Standard Error of the Mean|0.472|||2-Sided|95.0|-5.4|-3.5|||||Day 113||
1715711|NCT00767325|3157033|Superiority or Other||Mean Difference (Final Values)|-3.8|Standard Error of the Mean|0.454|||2-Sided|95.0|-4.7|-2.9|||||Day 85||
1715712|NCT00767325|3157033|Superiority or Other||Mean Difference (Final Values)|-3.2|Standard Error of the Mean|0.393|||2-Sided|95.0|-4.0|-2.4|||||Day 57||
1715713|NCT00767325|3157033|Superiority or Other||Mean Difference (Final Values)|-2.9|Standard Error of the Mean|0.384|||2-Sided|95.0|-3.7|-2.1|||||Day 43||
1715714|NCT00767325|3157033|Superiority or Other||Mean Difference (Final Values)|-2.4|Standard Error of the Mean|0.383|||2-Sided|95.0|-3.2|-1.7|||||Day 29||
1715715|NCT00767325|3157033|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|0.308|||2-Sided|95.0|-2.0|-0.7|||||Day 15||
1715716|NCT00767325|3157033|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.282|||2-Sided|95.0|-1.2|-0.1|||||Day 7||
1715717|NCT00767039|3157036|Superiority or Other||Risk Ratio (RR)|1.48|||>|0.05|2-Sided|90.0|0.84|2.63|||Mantel Haenszel||||
1715718|NCT00767039|3157037|Superiority or Other||Risk Ratio (RR)|1.44|||>|0.05|2-Sided|95.0|0.71|2.89|||Mantel Haenszel||||
1715719|NCT00767039|3157038|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1715720|NCT00767039|3157039|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).|
1715721|NCT00767039|3157040|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).|
1715722|NCT00767039|3157041|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1715723|NCT00767039|3157042|Superiority or Other||Risk Ratio (RR)|2.38|||<|0.01|2-Sided|95.0|1.29|4.38|||Mantel Haenszel||||
1715724|NCT00767039|3157043|Superiority or Other||Risk Ratio (RR)|0.49|||<|0.05|2-Sided|95.0|0.25|0.96|||Mantel Haenszel||||
1715727|NCT00767039|3157046|Superiority or Other||||||<|0.05||||||Tested null hypothesis. T-test and Generalized Linear Model was used to assess respiratory support parameters (mean airway pressure and percent fraction of inspiratory oxygen x mean airway pressure).|t-test, 2 sided|||Respiratory support were compared using a t-test for individual time points and Generalized Linear Model to account for correlations among repeated measures. Patient who survive >/= 3 days were included in the analysis.|
1715728|NCT00767000|3157051|Superiority or Other||Least Squares Mean Difference|6.7||||0.321||95.0|-6.6|20.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14|
1715729|NCT00767000|3157051|Superiority or Other||Least Squares Mean Difference|-9.3||||0.169||95.0|-22.6|4.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14|
1715730|NCT00767000|3157051|Superiority or Other||Least Squares Mean Difference|10.3||||0.121||95.0|-2.7|23.2|||Constrained longitudinal model|||Analysis for change from baseline to Week 14|
1715731|NCT00767000|3157051|Superiority or Other||Least Squares Mean Difference|1.8||||0.791||95.0|-11.6|15.2|||Constrained longitudinal model|||Analysis for change from baseline to Week 14|
1715732|NCT00767000|3157052|Superiority or Other||Least Squares Mean Difference|-36.9|||<|0.001||95.0|-55.9|-17.9|||Constrained longitudinal model|||Analysis for change from baseline to Week 14|
1715733|NCT00767000|3157052|Superiority or Other||Least Squares Mean Difference|-35.0|||<|0.001||95.0|-54.0|-16.0|||Constrained longitudinal model|||Analysis for change from baseline to Week 14|
1715734|NCT00767000|3157052|Superiority or Other||Least Squares Mean Difference|-26.7|||<|0.005||95.0|-45.4|-8.1|||Constrained longitudinal model|||Analysis for change from baseline to Week 14|
1715735|NCT00767000|3157052|Superiority or Other||Least Squares Mean Difference|-36.6|||<|0.001||95.0|-55.6|-17.5|||Constrained longitudial model|||Analysis for change from baseline to Week 14|
1715736|NCT00767000|3157053|Superiority or Other||Least Squares Mean Difference|-0.75|||<|0.001||95.0|-1.04|-0.46|||Constrained longitudinal model|||Analysis for change from baseline to Week 14|
1715737|NCT00767000|3157053|Superiority or Other||Least Squares Mean Difference|-0.81|||<|0.001||95.0|-1.1|-0.53|||Contrained longitudinal model|||Analysis for change from baseline to Week 14|
1715738|NCT00767000|3157053|Superiority or Other||Least Squares Mean Difference|-0.64|||<|0.001||95.0|-0.93|-0.36|||Constrained longitudinal model|||Analysis for change from baseline to Week 14|
1715739|NCT00767000|3157053|Superiority or Other||Least Squares Mean Difference|-0.51|||<|0.001||95.0|-0.8|-0.22|||Constrained longitudinal model|||Analysis for change from baseline to Week 14|
1715740|NCT00766506|3157104|Superiority or Other||Odds Ratio (OR)|1.72||||0.163|2-Sided|95.0|0.8|3.7|||Chi-squared|||NSAID's: P-value was calculated using Chi‐squared test.|
1715741|NCT00766506|3157104|Superiority or Other||Odds Ratio (OR)|1.61||||0.23|2-Sided|95.0|0.74|3.53|||Chi-squared|||Paracetamol: P-value was calculated using Chi‐squared test.|
1715742|NCT00766506|3157106|Superiority or Other||Odds Ratio (OR)|5.0||||0.029|2-Sided|95.0|1.04|24.03|||Chi-squared||||
1715743|NCT00766506|3157107|Superiority or Other|||||||0.836|||||||Log Rank|P-value was calculated from a log-rank test stratified for surgery type.|||
1715744|NCT00766506|3157108|Superiority or Other|||||||0.342|||||||Log Rank|P-value was calculated from a log-rank test stratified for surgery type.|||
1715745|NCT00766506|3157109|Superiority or Other||Odds Ratio (OR)|1.81||||0.131|2-Sided|95.0|0.84|3.92|||Mantel Haenszel|P-value was calculated from a Mantel-Haenszel Chi-Squared test.|||
1715746|NCT00766506|3157110|Superiority or Other||Least square mean difference|-0.52|||<|0.001|2-Sided|95.0|-0.74|-0.3|||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.|Least square mean difference = Least square mean value for Fentanyl IONSYS group minus Least square mean value for Morphine IV PCA group||
1715747|NCT00766506|3157111|Superiority or Other|||||||0.136|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At study discontinuation or withdrawal|
1715748|NCT00766506|3157111|Superiority or Other|||||||0.299|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At Hour 48|
1715749|NCT00766506|3157111|Superiority or Other|||||||0.219|||||||ANCOVA|P-value was calculated from ANCOVA, with centre, surgery type and treatment included as covariates in the analysis.||At Hour 24|
1715750|NCT00766506|3157112|Superiority or Other||Least square mean difference|-2.23|||<|0.001|2-Sided|95.0|-2.55|-1.91|||ANCOVA|P-value was calculated from analysis of covariance (ANCOVA), with centre, surgery type and treatment included as covariates in the analysis.|Least square mean difference = Least square mean value for Fentanyl IONSYS group minus Least square mean value for Morphine IV PCA group||
1715751|NCT00766493|3157117|Superiority or Other||Proportion|0.043|Standard Error of the Mean|0.013||0.0001|2-Sided|95.0|0.021|0.077||Reject H0 if z<-1.96, or 1-sided p<0.025.|One Sample Binomial|Significance test was based on a one-sample normal approximation to the binomial test.|The 2-sided 95% CI is reported for descriptive purposes; the statistical hypothesis test is 1-sided.|"This study is designed to test the primary null hypothesis that the composite MAE outcome of all death, stroke, and/or MI when using the GORE Embolic Filter is equal to or higher than a Performance Goal (PG) of 6.4% established from published carotid stenting studies utilizing distal embolic protection, versus the alternative hypothesis that the composite MAE outcome is less than the performance goal.~The sample size was calculated based on 80% power and a 1-sided Type I error rate of 0.025."|
1715752|NCT00766467|3157120|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)||||
1715753|NCT00766090|3157163|Superiority or Other||Mean Difference (Final Values)|0.132|||<|0.001|2-Sided|95.0|0.059|0.205|||ANCOVA||||
1715754|NCT00766090|3157163|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the lower limit of the confidence interval (0.025, 1-sided significance level) for the mean difference in trough FEV1 of FF 200 µg OD versus FF 100 µg BID was greater than -110 milliliters.|Mean Difference (Final Values)|0.011|||<|0.641|2-Sided|95.0|-0.035|0.056|||ANCOVA||||
1715755|NCT00766090|3157163|Superiority or Other||Mean Difference (Final Values)|0.087|||<|0.02|2-Sided|95.0|0.014|0.161|||ANCOVA||||
1715756|NCT00766090|3157163|Superiority or Other||Mean Difference (Final Values)|0.098|||<|0.001|2-Sided|95.0|0.054|0.142|||ANCOVA||||
1715758|NCT00766051|3157164|Superiority or Other||Mean Difference (Net)|2.8|Standard Deviation|4.3|<|0.03|1-Sided|95.0||4.54|||t-test, 1 sided||An increase in this test scale score means an increase in the parents' perception of their infants' easiness during caregiving.|Parent pre-post one sided t test on the Easiness Scale of the Mother and Baby Scales in how parents percieve their interactions (alert-responsiveness, mood) with their infant and infant sleep patterns .|
1715759|NCT00766051|3157165|Superiority or Other||Mean Difference (Net)|3.6|Standard Deviation|5.2|<|0.02|1-Sided|95.0||6.7|||t-test, 1 sided||An increase in this test scale score means more parent confidence.|"Parent pre-post one sided t test of parents' global confidence, measured parental confidence in feeding, handling, and interacting with their infant."|
1715760|NCT00766051|3157166|Superiority or Other||Slope|0.275|||<|0.01|||||||Mixed Models Analysis|This correlation is between the intervention groups' initial level of relaxation and final level of relaxation during the oral feeding period.||Pearson Correlation, 2-tailed|
1715761|NCT00766051|3157167|Superiority or Other||Mean Difference (Net)|8.0|Standard Error of the Mean|1.76|<|0.005|2-Sided|95.0|5.0|11.0||The P value is not adjusted for multiple comparisons or for statistical significance|t-test, 2 sided|||The expected outcome was that infants in the intervention group would exhibit significantly less number of days to attain oral feeding.|
1715762|NCT00765895|3157180|Superiority or Other (legacy)|||||||0.86|||||||Mantel Haenszel|Stratified by clinic|||
1715763|NCT00765882|3157188|Superiority or Other||Odds Ratio (OR)|4.22|||<|0.0001|2-Sided|95.0|2.2|8.1||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 290-μg dose and those taking placebo.~The power, adjusted for multiplicity, was expected to be 96% based on study NCT00460811 (MCP-103-202) data."|
1715764|NCT00765882|3157188|Superiority or Other||Odds Ratio (OR)|2.93|||<|0.0012|2-Sided|95.0|1.5|5.72||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 145-μg dose and those taking placebo.~The power, adjusted for multiplicity, was expected to be 90% based on study NCT00402337 (MCP-103-201) data."|
1715765|NCT00765843|3157189|Superiority or Other|||||||0.93|||||||ANOVA|||three months comparisons|
1715766|NCT00765843|3157189|Superiority or Other|||||||0.21|||||||ANOVA|||one month comparisons|
1715767|NCT00765843|3157189|Superiority or Other|||||||0.78|||||||ANOVA|||baseline comparisons|
1715768|NCT00765817|3157190|Superiority or Other|||||||0.486|||||||Fisher Exact||||
1715769|NCT00765817|3157191|Superiority or Other|||||||0.666|||||||Negative binomial regression model||||
1715770|NCT00765817|3157192|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1715771|NCT00765817|3157193|Superiority or Other|||||||0.011|||||||ANCOVA||||
1715772|NCT00765817|3157194|Superiority or Other|||||||0.07|||||||ANCOVA||||
1715773|NCT00765817|3157195|Superiority or Other|||||||0.026|||||||ANCOVA||||
1715774|NCT00765817|3157196|Superiority or Other|||||||0.226|||||||ANCOVA||||
1715775|NCT00765817|3157197|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1715776|NCT00765817|3157198|Superiority or Other|||||||0.933|||||||ANCOVA||||
1715777|NCT00765817|3157199|Superiority or Other|||||||0.745|||||||ANCOVA||||
1715778|NCT00765817|3157200|Superiority or Other|||||||0.063|||||||ANCOVA||||
1715779|NCT00765817|3157201|Superiority or Other|||||||0.203|||||||ANCOVA||||
1715780|NCT00765817|3157203|Superiority or Other|||||||0.174|||||||ANCOVA||||
1715781|NCT00765817|3157204|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1715782|NCT00765817|3157205|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1715783|NCT00765817|3157206|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1715784|NCT00765648|3157223|Superiority or Other|||||||0.11|||||||Wilcoxon (Mann-Whitney)||||
1715785|NCT00765648|3157224|Superiority or Other|||||||0.18|||||||Chi-squared||||
1715786|NCT00765648|3157225|Superiority or Other|||||||0.38|||||||Chi-squared||||
1715787|NCT00765648|3157226|Superiority or Other|||||||0.76|||||||Wilcoxon (Mann-Whitney)||||
1715788|NCT00765648|3157227|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1715789|NCT00765648|3157228|Superiority or Other||Risk Difference (RD)|-9.3||||0.04|2-Sided|95.0|-18.0|-0.6|||Chi-squared||||
1715790|NCT00765388|3157234|Superiority or Other|||||||0.48|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products|||
1715791|NCT00765388|3157235|Superiority or Other|||||||0.55|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products|||
1715792|NCT00765388|3157236|Superiority or Other|||||||0.64|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products|||
1715793|NCT00765388|3157237|Superiority or Other|||||||0.4|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference inthe multinomial distributions defined by products|||
1715794|NCT00765388|3157239|Superiority or Other|||||||0.92|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products|||
1715795|NCT00765388|3157241|Superiority or Other|||||||0.96|||||||Regression, Logistic|An ordinal logistic regression model. The null hypothesis tested is that there is no difference in the multinomial distributions defined by products|||
1715796|NCT00765193|3157257|Superiority or Other||Odds Ratio (OR)|2.36|||<|0.01||95.0|2.12|2.62|||Regression, Logistic|||The primary outcomes were the calculation of the absolute and relative risks of missing a skin cancer when TBSE is not performed, as well as the number of patients needed to examine by TBSE to find a skin cancer. The secondary outcome was to assess the magnitude of false-positive results obtained by TBSE|
1715800|NCT00764751|3157439|Superiority||Mean Difference (Final Values)|15.4|||=|0|2-Sided|95.0|5.6|25.0|||Paired t-test||||
1715801|NCT00764660|3157448|Superiority or Other||Difference in LS Means|-9.17||||0.05|2-Sided|95.0|-18.27|-0.07|||cLDA Model||cLDA Model with terms for treatment, pooled centers, assessment by treatment interaction.||
1715802|NCT00764660|3157449|Superiority or Other||Difference in LS Means|-3.1||||0.51|2-Sided|95.0|-12.35|6.15|||cLDA Model||cLDA Model with terms for treatment, pooled centers, assessment by treatment interaction.||
1715803|NCT00764660|3157450|Superiority or Other||Difference in LS Means|2.88||||0.54|2-Sided|95.0|-6.3|12.06|||Contrained Longitudinal Data Analysis||Constrained Longitudinal Data Analysis (cLDA) Model with terms for treatment, pooled centers, assessment by treatment interaction.||
1715804|NCT00764660|3157453|Superiority or Other||Odds Ratio (OR)|1.5||||0.34|2-Sided|95.0|0.65|3.43|||Regression, Logistic|An Odds Ratio (SCH 900435/Placebo) >1 means SCH 900435 has a higher probability of achieving complete abstinence.|||
1715805|NCT00764660|3157454|Superiority or Other||Difference in LS Means|-2.1||||0.59|2-Sided|95.0|-9.9|5.7|||Repeated Measures Model|Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.|||
1715806|NCT00764660|3157455|Superiority or Other||Hazard Ratio (HR)|1.31||||0.26|2-Sided|95.0|0.81|2.12||Model with factors treatment and pooled centers as stratum.|Kaplan-Meier||||
1715807|NCT00764660|3157456|Superiority or Other||Odds Ratio (OR)|0.96||||0.81|2-Sided|95.0|0.71|1.31|||Chi-squared|ZINB Distribution with terms for treatment and region|||
1715808|NCT00764660|3157457|Superiority or Other||Odds Ratio (OR)|0.87||||0.52|2-Sided|95.0|0.57|1.33|||Chi-squared|Zero Inflated Negative Binomial (ZINB) Distribution with terms for treatment and region|||
1715809|NCT00764660|3157458|Superiority or Other||Difference in Least Squares (LS) Means|-1.9||||0.3|2-Sided|95.0|-5.5|1.7|||Repeated Measures Model||Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.||
1715810|NCT00764660|3157459|Superiority or Other||Difference in LS Means|2.4||||0.41|2-Sided|95.0|-3.4|8.2|||Repeated Measures Model||Repeated Measures Model with factors for treatment, pooled centers, assessment and assessment by treatment interaction.||
1715811|NCT00764517|3157462|Other||Hazard Ratio (HR)|0.42||||0.011|2-Sided|95.0|0.21|0.84|||Log Rank||||
1715812|NCT00764517|3157463|Other||Hazard Ratio (HR)|0.33||||0.002|2-Sided|95.0|0.16|0.69|||Log Rank||||
1715813|NCT00764478|3157474|Superiority or Other||LS means difference|-0.9|Standard Error of the Mean|0.41||0.035|2-Sided|95.0|-1.7|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21|
1715814|NCT00764478|3157474|Superiority or Other||LS means difference|-1.1|Standard Error of the Mean|0.41||0.0054|2-Sided|95.0|-2.0|-0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1715815|NCT00764478|3157474|Superiority or Other||LS means difference|-0.9|Standard Error of the Mean|0.37||0.0123|2-Sided|95.0|-1.6|-0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14|
1715816|NCT00764478|3157474|Superiority or Other||LS means difference|-1.2|Standard Error of the Mean|0.36||0.0006|2-Sided|95.0|-2.0|-0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1715817|NCT00764478|3157474|Superiority or Other||LS means difference|-0.6|Standard Error of the Mean|0.33||0.0791|2-Sided|95.0|-1.2|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7|
1715818|NCT00764478|3157474|Superiority or Other||Least Square (LS) means difference|-1.0|Standard Error of the Mean|0.32||0.0019|2-Sided|95.0|-1.7|-0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1715819|NCT00764478|3157475|Superiority or Other||LS means difference|-1.1|Standard Error of the Mean|0.41||0.0096|2-Sided|95.0|-1.9|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21|
1715820|NCT00764478|3157475|Superiority or Other||LS means difference|-1.2|Standard Error of the Mean|0.4||0.0037|2-Sided|95.0|-2.0|-0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1715821|NCT00764478|3157475|Superiority or Other||LS means difference|-0.8|Standard Error of the Mean|0.39||0.0342|2-Sided|95.0|-1.6|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14|
1715822|NCT00764478|3157475|Superiority or Other||LS means difference|-0.7|Standard Error of the Mean|0.39||0.0861|2-Sided|95.0|-1.4|0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1715823|NCT00764478|3157475|Superiority or Other||LS means difference|-0.8|Standard Error of the Mean|0.34||0.0146|2-Sided|95.0|-1.5|-0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7|
1715824|NCT00764478|3157475|Superiority or Other||Least Square (LS) means difference|-0.9|Standard Error of the Mean|0.33||0.0101|2-Sided|95.0|-1.5|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1715825|NCT00764478|3157476|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.39||0.5615|2-Sided|95.0|-1.0|0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21|
1715826|NCT00764478|3157476|Superiority or Other||LS means difference|-0.5|Standard Error of the Mean|0.38||0.1969|2-Sided|95.0|-1.3|0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1715827|NCT00764478|3157476|Superiority or Other||LS means difference|-0.6|Standard Error of the Mean|0.37||0.0982|2-Sided|95.0|-1.3|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14|
1715828|NCT00764478|3157476|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.36||0.3683|2-Sided|95.0|-1.0|0.4|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1715829|NCT00764478|3157476|Superiority or Other||LS means difference|-0.6|Standard Error of the Mean|0.29||0.0589|2-Sided|95.0|-1.1|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7|
1715830|NCT00764478|3157476|Superiority or Other||Least Square (LS) means difference|-0.4|Standard Error of the Mean|0.29||0.2191|2-Sided|95.0|-0.9|0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1715831|NCT00764478|3157477|Superiority or Other||LS means difference|0.3|Standard Error of the Mean|0.38||0.5122|2-Sided|95.0|-0.5|1.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21|
1715832|NCT00764478|3157477|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.38||0.98|2-Sided|95.0|-0.7|0.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1715833|NCT00764478|3157477|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.34||0.7295|2-Sided|95.0|-0.6|0.8|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14|
1715871|NCT00764478|3157483|Superiority or Other|||||||0.026|||||||Cochran-Mantel-Haenszel|||Day 7|
1715834|NCT00764478|3157477|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.34||0.9109|2-Sided|95.0|-0.6|0.7|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1715835|NCT00764478|3157477|Superiority or Other||LS means difference|-0.4|Standard Error of the Mean|0.32||0.2754|2-Sided|95.0|-1.0|0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7|
1715836|NCT00764478|3157477|Superiority or Other||Least Square (LS) means difference|-0.1|Standard Error of the Mean|0.32||0.7746|2-Sided|95.0|-0.7|0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1715837|NCT00764478|3157478|Superiority or Other||LS means difference|-1.3|Standard Error of the Mean|0.48||0.0078|2-Sided|95.0|-2.2|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21|
1715838|NCT00764478|3157478|Superiority or Other||LS means difference|-0.9|Standard Error of the Mean|0.47||0.0531|2-Sided|95.0|-1.8|0.0|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1715839|NCT00764478|3157478|Superiority or Other||LS means difference|-0.9|Standard Error of the Mean|0.47||0.0514|2-Sided|95.0|-1.8|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14|
1715840|NCT00764478|3157478|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.46||0.9522|2-Sided|95.0|-0.9|0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1715841|NCT00764478|3157478|Superiority or Other||LS means difference|-0.6|Standard Error of the Mean|0.4||0.1684|2-Sided|95.0|-1.3|0.2|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7|
1715842|NCT00764478|3157478|Superiority or Other||Least Square (LS) means difference|-0.5|Standard Error of the Mean|0.4||0.1883|2-Sided|95.0|-1.3|0.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1715843|NCT00764478|3157479|Superiority or Other||LS means difference|-2.0|Standard Error of the Mean|0.85||0.0196|2-Sided|95.0|-3.7|-0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21|
1715844|NCT00764478|3157479|Superiority or Other||LS means difference|-2.6|Standard Error of the Mean|0.84||0.0022|2-Sided|95.0|-4.3|-0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1715845|NCT00764478|3157479|Superiority or Other||LS means difference|-2.2|Standard Error of the Mean|0.8||0.0064|2-Sided|95.0|-3.8|-0.6|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14|
1715846|NCT00764478|3157479|Superiority or Other||LS means difference|-2.1|Standard Error of the Mean|0.79||0.0083|2-Sided|95.0|-3.6|-0.5|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1715847|NCT00764478|3157479|Superiority or Other||LS means difference|-1.2|Standard Error of the Mean|0.65||0.0622|2-Sided|95.0|-2.5|0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7|
1715848|NCT00764478|3157479|Superiority or Other||Least Square (LS) means difference|-1.9|Standard Error of the Mean|0.64||0.0033|2-Sided|95.0|-3.2|-0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1715849|NCT00764478|3157480|Superiority or Other||LS means difference|-1.5|Standard Error of the Mean|0.51||0.0031|2-Sided|95.0|-2.5|-0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21|
1715850|NCT00764478|3157480|Superiority or Other||LS means difference|-1.1|Standard Error of the Mean|0.51||0.0258|2-Sided|95.0|-2.1|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1715851|NCT00764478|3157480|Superiority or Other||LS means difference|-1.1|Standard Error of the Mean|0.52||0.0398|2-Sided|95.0|-2.1|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14|
1715852|NCT00764478|3157480|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.51||0.6885|2-Sided|95.0|-1.2|0.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1715853|NCT00764478|3157480|Superiority or Other||LS means difference|-1.4|Standard Error of the Mean|0.42||0.0011|2-Sided|95.0|-2.2|-0.5|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7|
1715854|NCT00764478|3157480|Superiority or Other||Least Square (LS) means difference|-1.0|Standard Error of the Mean|0.41||0.012|2-Sided|95.0|-1.8|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1715855|NCT00764478|3157481|Superiority or Other||LS means difference|0.3|Standard Error of the Mean|0.39||0.3917|2-Sided|95.0|-0.4|1.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21|
1715856|NCT00764478|3157481|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.38||0.9654|2-Sided|95.0|-0.8|0.7|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1715857|NCT00764478|3157481|Superiority or Other||LS means difference|0.1|Standard Error of the Mean|0.33||0.7879|2-Sided|95.0|-0.6|0.7|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14|
1715858|NCT00764478|3157481|Superiority or Other||LS means difference|0.0|Standard Error of the Mean|0.32||0.9751|2-Sided|95.0|-0.6|0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1715859|NCT00764478|3157481|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.31||0.283|2-Sided|95.0|-0.9|0.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7|
1715860|NCT00764478|3157481|Superiority or Other||Least Square (LS) means difference|0.0|Standard Error of the Mean|0.3||0.9808|2-Sided|95.0|-0.6|0.6|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1715861|NCT00764478|3157482|Superiority or Other||LS means difference|-3.2|Standard Error of the Mean|1.43||0.0247|2-Sided|95.0|-6.1|-0.4|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 21|
1715862|NCT00764478|3157482|Superiority or Other||LS means difference|-3.8|Standard Error of the Mean|1.41||0.0081|2-Sided|95.0|-6.6|-1.0|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 21|
1715863|NCT00764478|3157482|Superiority or Other||LS means difference|-3.2|Standard Error of the Mean|1.35||0.0177|2-Sided|95.0|-5.9|-0.6|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14|
1715864|NCT00764478|3157482|Superiority or Other||LS means difference|-2.4|Standard Error of the Mean|1.33||0.0743|2-Sided|95.0|-5.0|0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1715865|NCT00764478|3157482|Superiority or Other||LS means difference|-2.9|Standard Error of the Mean|1.08||0.0068|2-Sided|95.0|-5.0|-0.8|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7|
1715866|NCT00764478|3157482|Superiority or Other||Least Square (LS) means difference|-3.0|Standard Error of the Mean|1.06||0.0056|2-Sided|95.0|-5.1|-0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1715867|NCT00764478|3157483|Superiority or Other|||||||0.0141|||||||Cochran-Mantel-Haenszel|||Day 21|
1715868|NCT00764478|3157483|Superiority or Other|||||||0.396|||||||Cochran-Mantel-Haenszel|||Day 21|
1715869|NCT00764478|3157483|Superiority or Other|||||||0.0077|||||||Cochran-Mantel-Haenszel|||Day 14|
1715870|NCT00764478|3157483|Superiority or Other|||||||0.2576|||||||Cochran-Mantel-Haenszel|||Day 14|
1715893|NCT00764478|3157485|Superiority or Other|||||||0.0588|||||||Cochran-Mantel-Haenszel|||Day 4|
1715894|NCT00764478|3157485|Superiority or Other|||||||0.1213|||||||Cochran-Mantel-Haenszel|||Day 4|
1715895|NCT00764478|3157485|Superiority or Other|||||||0.072|||||||Cochran-Mantel-Haenszel|||Day 2|
1715896|NCT00764478|3157485|Superiority or Other|||||||0.0147|||||||Cochran-Mantel-Haenszel|||Day 2|
1715897|NCT00764478|3157486|Superiority or Other|||||||0.0012|||||||ANCOVA|||Day 21|
1715898|NCT00764478|3157486|Superiority or Other|||||||0.0061|||||||ANCOVA|||Day 21|
1715899|NCT00764478|3157486|Superiority or Other|||||||0.0032|||||||ANCOVA|||Day 14|
1715900|NCT00764478|3157486|Superiority or Other|||||||0.0196|||||||ANCOVA|||Day 14|
1715901|NCT00764478|3157486|Superiority or Other|||||||0.0049|||||||ANCOVA|||Day 7|
1715902|NCT00764478|3157486|Superiority or Other|||||||0.0696|||||||ANCOVA|||Day 7|
1715903|NCT00764478|3157486|Superiority or Other|||||||0.8686|||||||ANCOVA|||Day 4|
1715904|NCT00764478|3157486|Superiority or Other|||||||0.5222|||||||ANCOVA|||Day 4|
1715905|NCT00764478|3157486|Superiority or Other|||||||0.7891|||||||ANCOVA|||Day 2|
1715906|NCT00764478|3157486|Superiority or Other|||||||0.9708|||||||ANCOVA|||Day 2|
1715907|NCT00764478|3157487|Superiority or Other|||||||0.0139|||||||ANCOVA|||Day 21|
1715908|NCT00764478|3157487|Superiority or Other|||||||0.064|||||||ANCOVA|||Day 21|
1715909|NCT00764478|3157487|Superiority or Other|||||||0.0613|||||||ANCOVA|||Day 14|
1715910|NCT00764478|3157487|Superiority or Other|||||||0.311|||||||ANCOVA|||Day 14|
1715911|NCT00764478|3157487|Superiority or Other|||||||0.0059|||||||ANCOVA|||Day 7|
1715912|NCT00764478|3157487|Superiority or Other|||||||0.0387|||||||ANCOVA|||Day 7|
1715913|NCT00764478|3157487|Superiority or Other|||||||0.0002|||||||ANCOVA|||Day 4|
1715914|NCT00764478|3157487|Superiority or Other|||||||0.0007|||||||ANCOVA|||Day 4|
1715915|NCT00764478|3157487|Superiority or Other|||||||0.0026|||||||ANCOVA|||Day 2|
1715916|NCT00764478|3157487|Superiority or Other|||||||0.0005|||||||ANCOVA|||Day 2|
1715917|NCT00764478|3157488|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.15||0.0376|2-Sided|95.0|-0.6|0.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14|
1715918|NCT00764478|3157488|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.14||0.1086|2-Sided|95.0|-0.5|0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1715919|NCT00764478|3157488|Superiority or Other||LS means difference|-0.4|Standard Error of the Mean|0.13||0.0031|2-Sided|95.0|-0.6|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7|
1715920|NCT00764478|3157488|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.12||0.0061|2-Sided|95.0|-0.6|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1715921|NCT00764478|3157488|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.1||0.004|2-Sided|95.0|-0.5|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 4|
1715922|NCT00764478|3157488|Superiority or Other||LS means difference|-0.4|Standard Error of the Mean|0.1||0.0004|2-Sided|95.0|-0.6|-0.2|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4|
1715923|NCT00764478|3157488|Superiority or Other||LS means difference|-0.2|Standard Error of the Mean|0.07||0.0076|2-Sided|95.0|-0.3|-0.1|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 2|
1715924|NCT00764478|3157488|Superiority or Other||LS means difference|-0.3|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|-0.4|-0.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 2|
1715925|NCT00764478|3157489|Superiority or Other|||||||0.0021|||||||ANCOVA|||Day 21|
1715926|NCT00764478|3157489|Superiority or Other|||||||0.0112|||||||ANCOVA|||Day 21|
1715927|NCT00764478|3157489|Superiority or Other|||||||0.0045|||||||ANCOVA|||Day 7|
1715928|NCT00764478|3157489|Superiority or Other|||||||0.0019|||||||ANCOVA|||Day 7|
1715929|NCT00764478|3157491|Superiority or Other|||||||0.1151|||||||Cochran-Mantel-Haenszel||||
1715930|NCT00764478|3157491|Superiority or Other|||||||0.2912|||||||Cochran-Mantel-Haenszel||||
1715931|NCT00764478|3157492|Superiority or Other|||||||0.2496|||||||Cochran-Mantel-Haenszel|||Day 14|
1715932|NCT00764478|3157492|Superiority or Other|||||||0.4858|||||||Cochran-Mantel-Haenszel|||Day 14|
1715933|NCT00764478|3157492|Superiority or Other|||||||0.0841|||||||Cochran-Mantel-Haenszel|||Day 7|
1715934|NCT00764478|3157492|Superiority or Other|||||||0.0194|||||||Cochran-Mantel-Haenszel|||Day 7|
1715935|NCT00764478|3157492|Superiority or Other|||||||0.0011|||||||Cochran-Mantel-Haenszel|||Day 4|
1715936|NCT00764478|3157492|Superiority or Other|||||||0.0011|||||||Cochran-Mantel-Haenszel|||Day 4|
1715937|NCT00764478|3157492|Superiority or Other|||||||0.1001|||||||Cochran-Mantel-Haenszel|||Day 2|
1715938|NCT00764478|3157492|Superiority or Other|||||||0.2922|||||||Cochran-Mantel-Haenszel|||Day 2|
1715939|NCT00764478|3157493|Superiority or Other||LS means difference|-3.1|Standard Error of the Mean|1.37||0.0238|2-Sided|95.0|-5.8|-0.4|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 14|
1715940|NCT00764478|3157493|Superiority or Other||LS means difference|-1.8|Standard Error of the Mean|1.35||0.1907|2-Sided|95.0|-4.4|0.9|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 14|
1715941|NCT00764478|3157493|Superiority or Other||LS means difference|-4.2|Standard Error of the Mean|1.13||0.0002|2-Sided|95.0|-6.4|-2.0|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 7|
1715942|NCT00764478|3157493|Superiority or Other||LS means difference|-3.5|Standard Error of the Mean|1.12||0.0021|2-Sided|95.0|-5.7|-1.3|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 7|
1715943|NCT00764478|3157493|Superiority or Other||LS means difference|-3.7|Standard Error of the Mean|0.92|<|0.0001|2-Sided|95.0|-5.5|-1.9|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 4|
1715944|NCT00764478|3157493|Superiority or Other||LS means difference|-3.6|Standard Error of the Mean|0.91|<|0.0001|2-Sided|95.0|-5.4|-1.8|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 4|
1715945|NCT00764478|3157493|Superiority or Other||LS means difference|-2.9|Standard Error of the Mean|0.79|<|0.0003|2-Sided|95.0|-4.4|-1.3|||MMRM||Asenapine 10 mg BID minus Placebo BID|Day 2|
1716151|NCT00762411|3157838|Superiority or Other|||||||0.622|||||||Mixed Models Analysis||||
1715946|NCT00764478|3157493|Superiority or Other||Least Square (LS) means difference|-2.7|Standard Error of the Mean|0.78|<|0.0007|2-Sided|95.0|-4.2|-1.1|||MMRM||Asenapine 5 mg BID minus Placebo BID|Day 2|
1715947|NCT00764478|3157494|Superiority or Other|||||||0.4274||||||Overall adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|Cochran-Mantel-Haenszel||||
1715948|NCT00764478|3157494|Superiority or Other|||||||0.5352||||||Overall adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|Cochran-Mantel-Haenszel||||
1715949|NCT00764478|3157495|Superiority or Other||LS means difference|-0.5|Standard Error of the Mean|0.16||0.0052|2-Sided|95.0|-0.9|-0.2||Adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|MMRM||Asenapine 10 mg BID minus Placebo BID||
1715950|NCT00764478|3157495|Superiority or Other||LS means difference|-0.5|Standard Error of the Mean|0.16||0.01|2-Sided|95.0|-0.8|-0.2||Adjusted p-value from Hochberg's method for testing two secondary efficacy hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID||
1715951|NCT00764478|3157496|Superiority or Other||LS means difference|-4.0|Standard Error of the Mean|1.43||0.01|2-Sided|95.0|-6.9|-1.2||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary hypotheses|MMRM||Asenapine 10 mg BID minus Placebo BID||
1715952|NCT00764478|3157496|Superiority or Other||Least Square (LS) means difference|-3.5|Standard Error of the Mean|1.41||0.0136|2-Sided|95.0|-6.3|-0.7||Adjusted p-value from graphical approach to control Type 1 error rate among primary and secondary hypotheses|MMRM||Asenapine 5 mg BID minus Placebo BID||
1715953|NCT00763971|3157516|Superiority or Other||difference in LS means|-0.2|||<|0.001|2-Sided|95.0|-0.3|-0.1|||ANCOVA||||
1715954|NCT00763971|3157516|Superiority or Other||difference in LS means|-0.3|||<|0.001|2-Sided|95.0|-0.4|-0.2|||ANCOVA||||
1715955|NCT00763971|3157517|Superiority or Other||difference in LS means|7.3|||<|0.001|2-Sided|95.0|4.6|10.0|||ANCOVA||||
1715956|NCT00763971|3157517|Superiority or Other||difference in LS means|8.8|||<|0.001|2-Sided|95.0|6.1|11.5|||ANCOVA||||
1715957|NCT00763971|3157519|Superiority or Other||difference in LS means|-15.1|||<|0.001|2-Sided|95.0|-19.3|-10.9|||ANCOVA||||
1715958|NCT00763971|3157519|Superiority or Other||difference in LS means|-21.3|||<|0.001|2-Sided|95.0|-25.5|-17.0|||ANCOVA||||
1715959|NCT00763971|3157520|Superiority or Other||difference in percentages|46.2|||<|0.001|2-Sided|95.0|34.6|57.7|||Cochran-Mantel-Haenszel||||
1715960|NCT00763971|3157520|Superiority or Other||difference in percentages|63.6|||<|0.001|2-Sided|95.0|53.0|74.1|||Cochran-Mantel-Haenszel||||
1715961|NCT00763971|3157521|Superiority or Other||difference in LS means|-13.0|||<|0.001|2-Sided|95.0|-15.9|-10.2|||ANCOVA||||
1715962|NCT00763971|3157521|Superiority or Other||difference in LS means|-18.6|||<|0.001|2-Sided|95.0|-21.5|-15.7|||ANCOVA||||
1715963|NCT00763919|3157525|Superiority or Other|||||||0.12|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.|
1715964|NCT00763919|3157526|Superiority or Other|||||||0.562|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.|
1715965|NCT00763919|3157527|Superiority or Other|||||||0.002|||||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.|
1715966|NCT00763919|3157528|Superiority or Other|||||||0.078|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.|
1715967|NCT00763919|3157529|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.|
1715968|NCT00763919|3157530|Superiority or Other|||||||0.072|||||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.|
1715969|NCT00763919|3157531|Superiority or Other|||||||0.096|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.|
1715970|NCT00763919|3157532|Superiority or Other|||||||0.003|||||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.|
1715971|NCT00763919|3157533|Superiority or Other|||||||0.101|||||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.|
1715972|NCT00763919|3157534|Superiority or Other|||||||0.246|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.|
1715973|NCT00763919|3157535|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.|
1715974|NCT00763919|3157536|Superiority or Other|||||||0.827|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.|
1715975|NCT00763919|3157537|Superiority or Other|||||||0.001|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.|
1715976|NCT00763919|3157538|Superiority or Other|||||||0.001|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.|
1715977|NCT00763919|3157539|Superiority or Other|||||||0.001|||||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.|
1715978|NCT00763919|3157540|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.|
1715979|NCT00763919|3157541|Superiority or Other|||||||0.044|||||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.|
1715980|NCT00763919|3157542|Superiority or Other|||||||0.042|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 6 months and baseline equals zero.|
1715981|NCT00763919|3157543|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||The null hypothesis is that the mean difference between 3 months and baseline equals zero.|
1715982|NCT00763919|3157544|Superiority or Other||||||<|0.001|||||||Sign test|||The null hypothesis is that the median difference between 3 months and baseline equals zero.|
1715983|NCT00763919|3157545|Superiority or Other||||||<|0.001|||||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.|
1715984|NCT00763919|3157546|Superiority or Other|||||||0.01|||||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.|
1715985|NCT00763919|3157547|Superiority or Other||||||<|0.001|||||||Sign test|||The null hypothesis is that the median difference between 6 months and baseline equals zero.|
1715986|NCT00763815|3157602|Superiority or Other||Least Squares (LS) Mean Difference|-0.56|Standard Error of the Mean|0.088|<|0.0001|2-Sided|95.0|-0.731|-0.386||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms; randomization strata of screening HbA1c (<8.0, >=8.0%), metformin use (yes, no); country as fixed effects; baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 300 patients in lixisenatide arm and 150 patients in placebo arm would provide a power of 96% (or 86%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.|
1715987|NCT00763698|3157605|Superiority or Other||Objective Performance Criteria|80.0|||||1-Sided|97.5|2.5||||||||
1715988|NCT00763698|3157606|Superiority or Other||Objective Performance Criteria|80.0|||||1-Sided|95.0|5.0|||||||The objective performance criteria established for freedom from left ventricular lead related complications at 3 months was greater than 80%. At least 80% of the patients were required to be free from left venticular lead related complications at 3 months.|
1715989|NCT00763451|3157618|Superiority or Other||Least squares (LS) mean difference|-0.49|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.67|-0.317||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|Threshold for significance at 0,05 level||"To detect a difference of 0.5% (or 0.4%) in absolute change from baseline in HbA1c at Week 24 between 1 lixisenatide arm and placebo (combined), 150 patients per group would provide a power of 91% (or 75%) assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.~Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (<8.0,>=8.0%) and screening BMI (<30,>=30 kg/m^2), country as fixed effects, baseline HbA1c as covariate."|
1715990|NCT00763451|3157618|Superiority or Other||Least squares (LS) mean difference|-0.41|Standard Error of the Mean|0.089|<|0.0001|2-Sided|95.0|-0.583|-0.232||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|Threshold for significance at 0,05 level||"To detect a difference of 0.5% (or 0.4%) in absolute change from baseline in HbA1c at Week 24 between 1 lixisenatide arm and placebo (combined), 150 patients per group would provide a power of 91% (or 75%) assuming common standard deviation of 1.3% with 2-sided test at 5% significance level.~Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (<8.0,>=8.0%) and screening BMI (<30,>=30 kg/m^2), country as fixed effects, baseline HbA1c as covariate."|
1715991|NCT00763269|3157641|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1715992|NCT00763269|3157642|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1715993|NCT00763269|3157643|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1715994|NCT00763269|3157644|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1715995|NCT00763256|3157645|Superiority or Other|||||||0.05|||||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.|
1715996|NCT00763256|3157646|Superiority or Other|||||||0.05|||||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.|
1715997|NCT00763256|3157647|Superiority or Other|||||||0.05|||||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.|
1715998|NCT00763256|3157648|Superiority or Other|||||||0.05|||||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.|
1715999|NCT00763256|3157649|Superiority or Other|||||||0.05|||||||t-test, 2 sided|||The null hypothesis states that there is no difference between groups.|
1716000|NCT00763243|3157650|Superiority or Other||Mean Difference (Final Values)|-0.67|Standard Deviation|2.5||0.4|2-Sided|95.0|-2.59|1.26|||t-test, 2 sided|t(8)=0.89||6 Month Follow Up period from pretraining|
1716001|NCT00763243|3157650|Superiority or Other||Mean Difference (Final Values)|-0.89|Standard Deviation|2.98||0.4|2-Sided|95.0|-3.17|1.4|||t-test, 2 sided|t(8)=0.90||1 Month Follow Up Period from Pretraining|
1716002|NCT00763243|3157650|Superiority or Other||Mean Difference (Final Values)|-1.78|Standard Deviation|2.17||0.039|2-Sided|95.0|-3.44|-0.11|||t-test, 2 sided|t(8)=2.46||Training Period - Pretraining to Post-Training Visit|
1716003|NCT00763243|3157650|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Deviation|1.86||0.729|2-Sided|95.0|-1.2|1.65|||t-test, 2 sided|t(8)=0.36||Waiting period - no treatment|
1716004|NCT00763243|3157651|Superiority or Other||Mean Difference (Final Values)|0.78|Standard Deviation|2.28||0.34|2-Sided|95.0|-0.97|2.53|||t-test, 2 sided|t(8)=1.02||6 month follow up change from pre-training|
1716005|NCT00763243|3157651|Superiority or Other||Mean Difference (Final Values)|2.11|Standard Deviation|3.06||0.072|2-Sided|95.0|-0.24|4.46|||t-test, 2 sided|t(8)=2.07||1 Month Follow Up change from pre-training|
1716006|NCT00763243|3157651|Superiority or Other||Mean Difference (Final Values)|2.44|Standard Deviation|1.81||0.004|2-Sided|95.0|1.05|3.84|||t-test, 2 sided|t(8)=4.05||Change during training period|
1716007|NCT00763243|3157651|Superiority or Other||Mean Difference (Final Values)|1.33|Standard Deviation|2.24||0.11|2-Sided|95.0|-0.39|3.05|||t-test, 2 sided|t(8)=1.79||Change during waiting period of no intervention|
1716008|NCT00763243|3157652|Superiority or Other||Mean Difference (Final Values)|0.33|Standard Deviation|1.12||0.4|2-Sided|95.0|-0.53|1.19|||t-test, 2 sided|t(8)=0.89||Change from pretraining to 6 month follow up|
1716009|NCT00763243|3157652|Superiority or Other||Mean Difference (Final Values)|1.78|Standard Deviation|1.86||0.021|2-Sided|95.0|0.35|3.2|||t-test, 2 sided|t(8)=2.87||Change from pre-training through follow-up period|
1716010|NCT00763243|3157652|Superiority or Other||Mean Difference (Final Values)|1.67|Standard Deviation|1.0|<|0.001|2-Sided|95.0|0.9|2.44|||t-test, 2 sided|t(8)=5.0||Change during the training period|
1716011|NCT00763243|3157652|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Deviation|2.17|<|0.766|2-Sided|95.0|-1.44|1.89|||t-test, 2 sided|t(8)=0.31||Change during waiting period (no intervention); no change was hypothesized|
1716012|NCT00763048|3157662|Superiority or Other|||||||0.05|||||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.|
1716013|NCT00763048|3157663|Superiority or Other|||||||0.05|||||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.|
1716014|NCT00763048|3157664|Superiority or Other|||||||0.05|||||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.|
1716015|NCT00763048|3157665|Superiority or Other|||||||0.05|||||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.|
1716016|NCT00763048|3157666|Superiority or Other|||||||0.05|||||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.|
1716017|NCT00763048|3157667|Superiority or Other|||||||0.05|||||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.|
1716018|NCT00763048|3157668|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.|
1716019|NCT00763048|3157669|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.|
1716020|NCT00763048|3157670|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|||The null hypothesis states that there is no difference between groups.|
1716021|NCT00762996|3157680|Superiority or Other||Mean Difference (Final Values)|0.4757|Standard Error of the Mean|0.2505||||95.0|0.05563|0.4757|||||Mean difference is etafilcon A minus omafilcon A.||
1716022|NCT00762996|3157681|Non-Inferiority or Equivalence|"margin +/- 0.5 logMar lines~The range of non-inferiority for this value is 0.50 thus +/- 0.50 is considered non-inferior to the 0.0 mark.~logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal."|Mean Difference (Final Values)|0.005287|Standard Error of the Mean|0.00976||||95.0|-0.01389|0.2447|||||logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.|Null Hypothesis: etafilcon A is greater than or equal to omafilcon A.|
1716023|NCT00762853|3157691|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716024|NCT00762762|3157694|Superiority or Other|||||||0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716025|NCT00762762|3157695|Superiority or Other|||||||0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716026|NCT00762762|3157696|Superiority or Other|||||||0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716027|NCT00762762|3157697|Superiority or Other|||||||0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716028|NCT00762762|3157698|Superiority or Other|||||||0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716029|NCT00762619|3157702|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716030|NCT00762619|3157703|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716031|NCT00762619|3157704|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716032|NCT00762619|3157705|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716033|NCT00762619|3157706|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716034|NCT00762619|3157707|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716035|NCT00762619|3157708|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716036|NCT00762619|3157709|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716037|NCT00762619|3157710|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716038|NCT00762619|3157711|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716039|NCT00762619|3157712|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716040|NCT00762619|3157713|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716041|NCT00762619|3157714|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716042|NCT00762619|3157715|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716043|NCT00762619|3157716|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716044|NCT00762619|3157717|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716045|NCT00762619|3157718|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716046|NCT00762619|3157719|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716047|NCT00762619|3157720|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716048|NCT00762619|3157721|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716049|NCT00762619|3157722|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716050|NCT00762619|3157723|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716051|NCT00762619|3157724|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716052|NCT00762619|3157725|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716053|NCT00762619|3157726|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716054|NCT00762619|3157727|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716055|NCT00762619|3157728|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716056|NCT00762619|3157729|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716057|NCT00762619|3157730|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716058|NCT00762619|3157731|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716059|NCT00762619|3157732|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716060|NCT00762619|3157733|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716061|NCT00762619|3157734|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716062|NCT00762619|3157735|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716063|NCT00762619|3157736|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716064|NCT00762619|3157737|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716065|NCT00762619|3157738|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716066|NCT00762619|3157739|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716067|NCT00762619|3157740|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716068|NCT00762619|3157741|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716069|NCT00762619|3157742|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716070|NCT00762619|3157743|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716071|NCT00762619|3157744|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716072|NCT00762619|3157745|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716073|NCT00762619|3157746|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716074|NCT00762619|3157747|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716075|NCT00762619|3157748|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716076|NCT00762619|3157749|Superiority or Other|||||||0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716077|NCT00762619|3157750|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716078|NCT00762619|3157751|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716079|NCT00762619|3157752|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716080|NCT00762619|3157753|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716081|NCT00762619|3157754|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716082|NCT00762619|3157755|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716083|NCT00762619|3157756|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716084|NCT00762619|3157757|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716085|NCT00762619|3157758|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716086|NCT00762619|3157759|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716087|NCT00762619|3157760|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716088|NCT00762619|3157761|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716089|NCT00762619|3157762|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716090|NCT00762619|3157763|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716091|NCT00762619|3157764|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716092|NCT00762619|3157765|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716093|NCT00762619|3157766|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716094|NCT00762619|3157767|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716095|NCT00762619|3157768|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716096|NCT00762619|3157769|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716097|NCT00762528|3157772|Superiority or Other||||||<|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716098|NCT00762528|3157773|Superiority or Other||||||<|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716099|NCT00762528|3157774|Superiority or Other||||||<|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716100|NCT00762528|3157775|Superiority or Other||||||<|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716101|NCT00762528|3157776|Superiority or Other||||||<|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716102|NCT00762528|3157777|Superiority or Other||||||<|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716103|NCT00762528|3157778|Superiority or Other||||||<|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716104|NCT00762528|3157779|Superiority or Other||||||<|0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716105|NCT00762515|3157780|Superiority or Other||||||<|0.05|||||||ANCOVA|baseline to be used a factor||The null hypothesis states that there is no difference between groups.|
1716106|NCT00762515|3157781|Superiority or Other||||||<|0.05|||||||ANCOVA|baseline is used a factor||The null hypothesis states that there is no difference between groups.|
1716107|NCT00762476|3157786|Superiority or Other|||||||0.3451|||||||Poisson regression||||
1716108|NCT00762476|3157787|Superiority or Other||||||>|0.5|||||||Poisson regression||||
1716109|NCT00762476|3157788|Superiority or Other||||||>|0.5|||||||Poisson regression||||
1716110|NCT00762463|3157793|Superiority or Other||LS Mean Difference|-1.44|Standard Error of the Mean|2.221||0.5183|2-Sided|95.0|-5.82|2.94|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716111|NCT00762463|3157795|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|1.81||0.7003|2-Sided|95.0|-4.3|2.9|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716112|NCT00762463|3157797|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.14||0.534|2-Sided|95.0|-0.2|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716113|NCT00762463|3157797|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|0.13||0.2202|2-Sided|95.0|-0.1|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716114|NCT00762463|3157797|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.11||0.878|2-Sided|95.0|-0.2|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716115|NCT00762463|3157799|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.95||0.7529|2-Sided|95.0|-1.6|2.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716116|NCT00762463|3157799|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.98||0.7749|2-Sided|95.0|-1.6|2.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716117|NCT00762463|3157799|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.87||0.9641|2-Sided|95.0|-1.7|1.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716118|NCT00762463|3157801|Superiority or Other||LS Mean Difference|4.0|Standard Error of the Mean|2.76||0.1464|2-Sided|95.0|-1.4|9.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716119|NCT00762463|3157801|Superiority or Other||LS Mean Difference|2.5|Standard Error of the Mean|2.74||0.3574|2-Sided|95.0|-2.9|7.9|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716120|NCT00762463|3157801|Superiority or Other||LS Mean Difference|4.3|Standard Error of the Mean|2.67||0.1111|2-Sided|95.0|-1.0|9.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716121|NCT00762463|3157804|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.22||0.1559|2-Sided|95.0|-0.1|0.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716122|NCT00762463|3157804|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|0.21||0.2729|2-Sided|95.0|-0.2|0.6|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716123|NCT00762463|3157804|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.2||0.6335|2-Sided|95.0|-0.3|0.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716124|NCT00762463|3157806|Superiority or Other||LS Mean Difference|0.3|Standard Error of the Mean|0.2||0.179|2-Sided|95.0|-0.1|0.7|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716125|NCT00762463|3157806|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.2||0.5916|2-Sided|95.0|-0.3|0.5|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716126|NCT00762463|3157806|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.18||0.9358|2-Sided|95.0|-0.3|0.4|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716127|NCT00762463|3157808|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.08||0.6522|2-Sided|95.0|-0.1|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716128|NCT00762463|3157808|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.07||0.3427|2-Sided|95.0|-0.1|0.2|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716129|NCT00762463|3157808|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.07||0.5945|2-Sided|95.0|-0.2|0.1|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716130|NCT00762463|3157810|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.09||0.1502|2-Sided|95.0|-0.05|0.29|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 6. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716131|NCT00762463|3157810|Superiority or Other||LS Mean Difference|0.2|Standard Error of the Mean|0.08||0.0426|2-Sided|95.0|0.01|0.31|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716132|NCT00762463|3157810|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.08||0.8938|2-Sided|95.0|-0.15|0.17|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716133|NCT00762463|3157812|Superiority or Other||LS Mean Difference|2.6|Standard Error of the Mean|2.62||0.3223|2-Sided|95.0|-2.6|7.8|||ANCOVA|Change from baseline was analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 4. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716134|NCT00762463|3157812|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|2.5||0.7849|2-Sided|95.0|-5.6|4.2|||ANCOVA|Change from baseline analyzed using ANCOVA with treatment group and investigational centers as factors and baseline value as a covariate.||Change from baseline to Week 2. The p-value is for the null hypothesis test H0: u1=u2 vs. H1: u1 is not equal to u2.|
1716135|NCT00762463|3157814|Non-Inferiority or Equivalence|LS mean difference calculated as LS mean change for Celecoxib 200 mg once daily minus LS mean change for Diclofenac SR 75 mg once daily. Non-inferiority was declared if the upper bound of the 95% confidence interval was <10 mm.|LS Mean Difference|3.3|Standard Error of the Mean|2.79||0.0085|2-Sided|95.0|-2.2|8.8|||ANCOVA|Analysis of covariance (ANCOVA); factors: treatment group and study center; covariate: baseline Patient’s Assessment of Global Pain Intensity score.||"Null hypothesis: Least Squares (LS) mean difference between Celecoxib 200 mg once daily versus Diclofenac SR 75 mg once daily on change in Global Pain Intensity from baseline to Week 6 was at least 10 mm. Corresponding alternative hypothesis: This difference was <10 mm.~For the non-inferiority test, power was 80% and significance level was 0.025 (1-sided)."|
1716136|NCT00762450|3157815|Superiority or Other|||||||0.05|||||||ANOVA|paired t-tests||The null hypothesis states that there is no difference between groups.|
1716137|NCT00762411|3157817|Superiority or Other|||||||0.893|||||||Mixed Models Analysis||||
1716138|NCT00762411|3157818|Superiority or Other|||||||0.805|||||||Mixed Models Analysis||||
1716139|NCT00762411|3157819|Superiority or Other|||||||0.417|||||||ANCOVA||||
1716140|NCT00762411|3157820|Superiority or Other|||||||0.318|||||||ANCOVA||||
1716141|NCT00762411|3157821|Superiority or Other|||||||0.437|||||||Mixed Models Analysis||||
1716142|NCT00762411|3157822|Superiority or Other|||||||0.929|||||||Mixed Models Analysis||||
1716143|NCT00762411|3157831|Superiority or Other|||||||0.117|||||||ANCOVA||||
1716144|NCT00762411|3157832|Superiority or Other|||||||0.326|||||||ANCOVA||||
1716145|NCT00762411|3157833|Superiority or Other|||||||0.772||||||This is the p-value for the Left Hippocampal Volume.|ANCOVA||||
1716146|NCT00762411|3157833|Superiority or Other|||||||0.101||||||This is the p-value for the Right Hippocampal Volume.|ANCOVA||||
1716147|NCT00762411|3157834|Superiority or Other|||||||0.426|||||||ANCOVA||||
1716148|NCT00762411|3157835|Superiority or Other|||||||0.009|||||||ANCOVA||||
1716149|NCT00762411|3157836|Superiority or Other|||||||0.632|||||||Mixed Models Analysis||||
1716150|NCT00762411|3157837|Superiority or Other|||||||0.178|||||||Mixed Models Analysis||||
1716152|NCT00762411|3157839|Superiority or Other|||||||0.673|||||||ANCOVA||||
1716153|NCT00762411|3157840|Superiority or Other|||||||0.477|||||||Mixed Models Analysis||||
1716154|NCT00762411|3157841|Superiority or Other|||||||0.294|||||||Mixed Models Analysis||||
1716155|NCT00762411|3157842|Superiority or Other|||||||0.199|||||||Mixed Models Analysis||||
1716156|NCT00762411|3157843|Superiority or Other|||||||0.567|||||||Mixed Models Analysis||||
1716157|NCT00762411|3157844|Superiority or Other|||||||0.959|||||||Mixed Models Analysis||||
1716158|NCT00762411|3157845|Superiority or Other|||||||0.56|||||||Mixed Models Analysis||||
1716159|NCT00762385|3157846|Superiority or Other||Mean Difference (Final Values)|0.2726|Standard Error of the Mean|0.1064||||98.3|0.04553|0.2726|||||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.|
1716160|NCT00762385|3157847|Superiority or Other||Mean Difference (Final Values)|0.00556|Standard Error of the Mean|0.02287||||98.3|-0.04297|0.00556|||||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.|
1716161|NCT00762385|3157848|Superiority or Other||Mean Difference (Final Values)|0.03164|Standard Error of the Mean|0.1247||||98.3|-0.2346|0.03164|||||Mean difference is galyfilcon A minus comfilcon A.|Results is overall lens effect with time as a covariate.|
1716162|NCT00762372|3157852|Non-Inferiority|Fisher's exact test||||||1|||||||Fisher Exact||||
1716163|NCT00762372|3157854|Non-Inferiority|Fisher's exact test||||||0.3113|||||||Fisher Exact||||
1716164|NCT00762372|3157858|Non-Inferiority|Two-sample t-test||||||0.0001|||||||t-test, 2 sided||||
1716165|NCT00762372|3157859|Non-Inferiority|"Adjusted means of time from the end of study drug inhalation to extubation in the BLM-240 N2O group and sevoflurane group, which were obtained by analysis of covariance with surgical site and surgery time as covariates, were used to verify the non-inferiority of BLM-240 to the comparator sevoflurane, with a delta = 1.0 (minute) and significance level alpha = 2.5% (one-sided)."||||||0.15|||||||t-test, 2 sided||||
1716166|NCT00762372|3157860|Non-Inferiority|Time to extubation = treatment group + surgical site +surgery time|Mean Difference (Final Values)|-4.6|Standard Error of the Mean|1.0|||2-Sided|95.0|-6.6|-2.7|||||||
1716167|NCT00762359|3157869|Superiority or Other|||||||0.4497|||||||Wilcoxon (Mann-Whitney)||||
1716168|NCT00762359|3157870|Superiority or Other|||||||0.9015|||||||Wilcoxon (Mann-Whitney)||||
1716169|NCT00762359|3157871|Superiority or Other|||||||0.6818|||||||Wilcoxon (Mann-Whitney)||||
1716170|NCT00762359|3157872|Superiority or Other|||||||0.2604|||||||Wilcoxon (Mann-Whitney)||||
1716171|NCT00762359|3157874|Superiority or Other|||||||0.4484|||||||Wilcoxon (Mann-Whitney)||||
1716172|NCT00762359|3157875|Superiority or Other|||||||0.4718|||||||Wilcoxon (Mann-Whitney)||||
1716173|NCT00762359|3157876|Superiority or Other|||||||0.4496|||||||Wilcoxon (Mann-Whitney)||||
1716174|NCT00762359|3157877|Superiority or Other|||||||0.6175|||||||Wilcoxon (Mann-Whitney)||||
1716175|NCT00762359|3157879|Superiority or Other|||||||0.145|||||||Wilcoxon (Mann-Whitney)||||
1716176|NCT00762359|3157880|Superiority or Other|||||||0.3128|||||||Wilcoxon (Mann-Whitney)||||
1716177|NCT00762359|3157881|Superiority or Other|||||||0.0141|||||||Wilcoxon (Mann-Whitney)||||
1716178|NCT00762359|3157882|Superiority or Other|||||||0.2694|||||||Wilcoxon (Mann-Whitney)||||
1716179|NCT00762359|3157884|Superiority or Other|||||||0.1229|||||||Wilcoxon (Mann-Whitney)||||
1716180|NCT00762359|3157885|Superiority or Other|||||||0.0059|||||||Wilcoxon (Mann-Whitney)||||
1716181|NCT00762359|3157886|Superiority or Other|||||||0.0046|||||||Wilcoxon (Mann-Whitney)||||
1716182|NCT00762359|3157887|Superiority or Other|||||||0.0204|||||||Wilcoxon (Mann-Whitney)||||
1716183|NCT00762359|3157889|Superiority or Other|||||||0.7619|||||||Wilcoxon (Mann-Whitney)||||
1716184|NCT00762359|3157890|Superiority or Other|||||||0.7382|||||||Wilcoxon (Mann-Whitney)||||
1716185|NCT00762359|3157891|Superiority or Other|||||||0.5485|||||||Wilcoxon (Mann-Whitney)||||
1716186|NCT00762359|3157892|Superiority or Other|||||||0.8604|||||||Wilcoxon (Mann-Whitney)||||
1716187|NCT00762359|3157894|Superiority or Other|||||||0.1862|||||||Wilcoxon (Mann-Whitney)||||
1716188|NCT00762359|3157895|Superiority or Other|||||||0.8813|||||||Wilcoxon (Mann-Whitney)||||
1716189|NCT00762359|3157896|Superiority or Other|||||||0.34|||||||Wilcoxon (Mann-Whitney)||||
1716190|NCT00762359|3157897|Superiority or Other|||||||0.7054|||||||Wilcoxon (Mann-Whitney)||||
1716191|NCT00762359|3157899|Superiority or Other|||||||0.2688|||||||Wilcoxon (Mann-Whitney)||||
1716192|NCT00762359|3157900|Superiority or Other|||||||0.8678|||||||Wilcoxon (Mann-Whitney)||||
1716193|NCT00762359|3157901|Superiority or Other|||||||0.805|||||||Wilcoxon (Mann-Whitney)||||
1716194|NCT00762359|3157902|Superiority or Other|||||||0.6148|||||||Wilcoxon (Mann-Whitney)||||
1716195|NCT00762359|3157903|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1716196|NCT00762359|3157905|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1716197|NCT00762359|3157906|Superiority or Other|||||||0.0025|||||||Wilcoxon (Mann-Whitney)||||
1716198|NCT00762359|3157907|Superiority or Other|||||||0.0006|||||||Wilcoxon (Mann-Whitney)||||
1716199|NCT00762359|3157908|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1716200|NCT00762359|3157910|Superiority or Other|||||||0.0433|||||||Wilcoxon (Mann-Whitney)||||
1716201|NCT00762359|3157911|Superiority or Other|||||||0.0079|||||||Wilcoxon (Mann-Whitney)||||
1716202|NCT00762359|3157912|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1716203|NCT00762359|3157913|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1716204|NCT00762359|3157914|Superiority or Other||Hazard Ratio (HR)|0.0989|||<|0.0001|2-Sided|95.0|0.0425|0.23|||Log Rank||||
1716205|NCT00762320|3157915|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|df=7|||
1716206|NCT00762320|3157920|Superiority or Other||||||=|0|||||||t-test, 2 sided|df=4|||
1716207|NCT00762268|3157925|Other|||||||0.05|||||||Chi-squared||||
1716208|NCT00762268|3157926|Other|||||||0.05|||||||Chi-squared|||Change from intake scores.|
1716209|NCT00762268|3157927|Superiority or Other|||||||1|||||||Regression, Linear||||
1716210|NCT00762177|3157932|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716211|NCT00762177|3157933|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716212|NCT00762177|3157934|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716213|NCT00762177|3157935|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716214|NCT00762177|3157936|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716215|NCT00762177|3157937|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716216|NCT00762177|3157938|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716217|NCT00762177|3157939|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716218|NCT00762177|3157940|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716219|NCT00762177|3157941|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716220|NCT00762177|3157942|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716221|NCT00762177|3157943|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716222|NCT00762177|3157944|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716223|NCT00762177|3157945|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716224|NCT00762177|3157946|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716225|NCT00762177|3157947|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716226|NCT00762177|3157948|Superiority or Other|||||||0.05|||||||ANCOVA|||the tongue will be scrapped 5 times with the edge of a tongue depressor. The depressor is vortex in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar|
1716227|NCT00762177|3157949|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716228|NCT00762177|3157950|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716229|NCT00762177|3157951|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716230|NCT00762177|3157952|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716231|NCT00762177|3157953|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716232|NCT00762177|3157954|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716233|NCT00762177|3157955|Superiority or Other|||||||0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716234|NCT00762073|3157964|Superiority or Other|||||||0.8987||||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA||||
1716235|NCT00762073|3157964|Superiority or Other|||||||0.9787||||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA||||
1716236|NCT00762073|3157964|Superiority or Other|||||||0.4197||||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA||||
1716237|NCT00762073|3157965|Superiority or Other|||||||0.1532||||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA||||
1716238|NCT00762073|3157965|Superiority or Other|||||||0.8894||||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA||||
1716239|NCT00762073|3157965|Superiority or Other|||||||0.6729||||||p-values comparing percent change from Baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA||||
1716240|NCT00762073|3157966|Superiority or Other|||||||0.3215||||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic||||
1716241|NCT00762073|3157966|Superiority or Other|||||||0.9258||||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic||||
1716242|NCT00762073|3157966|Superiority or Other|||||||0.3444||||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic||||
1716243|NCT00762073|3157967|Superiority or Other|||||||0.1235||||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic||||
1716244|NCT00762073|3157967|Superiority or Other|||||||0.9363||||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic||||
1716245|NCT00762073|3157967|Superiority or Other|||||||0.3769||||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic||||
1716246|NCT00762073|3157968|Superiority or Other|||||||0.001||||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA||||
1716247|NCT00762073|3157968|Superiority or Other|||||||0.0264||||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA||||
1716248|NCT00762073|3157968|Superiority or Other|||||||0.1095||||||p-values comparing each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate|ANCOVA||||
1716249|NCT00762073|3157969|Superiority or Other||||||<|0.0001||||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA||||
1716250|NCT00762073|3157969|Superiority or Other||||||<|0.0208||||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA||||
1716251|NCT00762073|3157969|Superiority or Other||||||<|0.0108||||||p-values comparing percent change from baseline for each active treatment group to placebo were determined by an ANCOVA model with treatment and age strata as main effects and baseline as a covariate.|ANCOVA||||
1716252|NCT00762073|3157970|Superiority or Other||||||<|0.0001||||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic||||
1716253|NCT00762073|3157970|Superiority or Other||||||<|0.004||||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic||||
1716254|NCT00762073|3157970|Superiority or Other||||||<|0.4959||||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic||||
1716255|NCT00762073|3157971|Superiority or Other|||||||0.0001||||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic||||
1716256|NCT00762073|3157971|Superiority or Other|||||||0.009||||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic||||
1716257|NCT00762073|3157971|Superiority or Other|||||||0.1786||||||p-values were determined by a logistic regression analysis with treatment (all four groups) and age group as main effects.|Regression, Logistic||||
1716258|NCT00762073|3157972|Superiority or Other||Odds Ratio (OR)|15.009||||0.0174|2-Sided|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic||||
1716259|NCT00762073|3157972|Superiority or Other||Odds Ratio (OR)|18.86||||0.0092|2-Sided|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic||||
1716260|NCT00762073|3157972|Superiority or Other||Odds Ratio (OR)|2.239||||0.5282|2-Sided|||||p-values comparing each active treatment group to placebo were determined by a logistic regression analysis with treatment (all four groups) and age as main effects.|Regression, Logistic||||
1716261|NCT00762034|3157973|Superiority or Other||Hazard Ratio (HR)|0.859||||0.455|2-Sided|95.0|0.575|1.281||p-value for FR-α Membrane Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox||||
1716262|NCT00762034|3157973|Superiority or Other||Hazard Ratio (HR)|0.96||||0.905|2-Sided|95.0|0.49|1.88||p-value for FR-α Membrane Positive (H score > 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox||||
1716263|NCT00762034|3157973|Superiority or Other||Hazard Ratio (HR)|0.592||||0.06|2-Sided|95.0|0.342|1.023||p-value for FR-α Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox||||
1716264|NCT00762034|3157973|Superiority or Other||Hazard Ratio (HR)|0.97||||0.891|2-Sided|95.0|0.622|1.511||p-value for FR-α Cytoplasm Positive (H score > 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox||||
1716265|NCT00762034|3157974|Superiority or Other||Hazard Ratio (HR)|0.969||||0.915|2-Sided|95.0|0.54|1.738||p-value is for TS Nucleus Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox||||
1716266|NCT00762034|3157974|Superiority or Other||Hazard Ratio (HR)|0.759||||0.2|2-Sided|95.0|0.498|1.157||p-value is for TS Nucleus Positive (H score > 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox||||
1716267|NCT00762034|3157974|Superiority or Other||Hazard Ratio (HR)|0.521||||0.287|2-Sided|95.0|0.157|1.729||p-value is for TS Cytoplasm Negative (H score = 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox||||
1716268|NCT00762034|3157974|Superiority or Other||Hazard Ratio (HR)|0.927||||0.673|2-Sided|95.0|0.654|1.316||p-value is for TS Cytoplasm Positive (H score > 0) comparing treatment arms and was not adjusted for multiple comparisons.|Regression, Cox||||
1716269|NCT00762034|3157975|Superiority or Other||Hazard Ratio (HR)|0.48|||<|0.001|2-Sided|95.0|0.338|0.681||p-value was not adjusted for multiple comparisons.|Regression, Cox||||
1716270|NCT00762034|3157989|Superiority or Other||||||<|0.001||||||p-value for FACT/GOG-Ntx TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis||||
1716271|NCT00762034|3157989|Superiority or Other||||||<|0.001||||||p-value for FACT/GOG-Ntx Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis||||
1716272|NCT00762034|3157990|Superiority or Other|||||||0.978||||||p-value for FACT-L TOI; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis||||
1716273|NCT00762034|3157990|Superiority or Other|||||||0.815||||||p-value for FACT-L Total; Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis||||
1716274|NCT00762034|3157991|Superiority or Other|||||||0.667||||||Mixed Model Analysis has treatment, baseline, time point, and treatment by timepoint interaction as fixed effects.|Mixed Models Analysis||||
1716275|NCT00762034|3157996|Superiority or Other||Hazard Ratio (HR)|0.79||||0.006|2-Sided|95.0|0.67|0.94|||Log Rank||||
1716276|NCT00762034|3157997|Superiority or Other||Hazard Ratio (HR)|0.83||||0.01206|2-Sided|95.0|0.71|0.96|||Log Rank||||
1716277|NCT00762034|3157998|Superiority or Other|||||||0.20892|||||||Fisher Exact||||
1716278|NCT00762034|3157999|Superiority or Other|||||||0.72997|||||||Fisher Exact||||
1716279|NCT00762034|3158000|Superiority or Other||Hazard Ratio (HR)|1.0||||0.94896|2-Sided|95.0|0.86|1.16|||Log Rank||||
1716280|NCT00761969|3158005|Superiority or Other||||||<|0.001|||||||Log Rank|||Survival, major-event-free survival and event-free survival of patients with PAD and control subjects was estimated by the Kaplan-Meier method and compared by the log-rank test. The numbers of non-fatal events and revascularization procedures (which could be more than one per person) were compared using the Poisson regression – the outcome being the number of events per person-year.|
1716281|NCT00761930|3158008|Superiority or Other||||||<|0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716282|NCT00761930|3158009|Superiority or Other||||||<|0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716283|NCT00761930|3158010|Superiority or Other||||||<|0.05|||||||ANCOVA|||The null hypothesis states that there is no difference between groups.|
1716284|NCT00761813|3158015|Superiority|||||||0.05|||||||Chi-squared||||
1716285|NCT00761813|3158016|Superiority||Cox Proportional Hazard|0.83|||||2-Sided|95.0|0.63|1.09|||||||
1716286|NCT00761631|3158038|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||2-Sided|95.0|0.91|1.28||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).|
1716287|NCT00761631|3158038|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.6|||||2-Sided|95.0|0.53|0.76||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).|
1716288|NCT00761631|3158038|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||2-Sided|95.0|1.05|1.67||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).|
1716289|NCT00761631|3158038|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||2-Sided|95.0|0.53|0.89||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).|
1716290|NCT00761631|3158038|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.6|||||2-Sided|95.0|0.48|0.67||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).|
1716291|NCT00761631|3158038|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||2-Sided|95.0|1.36|2.13||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).|
1716292|NCT00761631|3158038|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||2-Sided|95.0|0.97|1.42||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).|
1716293|NCT00761631|3158038|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||2-Sided|95.0|1.15|1.86||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).|
1716294|NCT00761631|3158038|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.7|||||2-Sided|95.0|0.59|0.86||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).|
1716295|NCT00761631|3158038|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||2-Sided|95.0|1.19|1.76||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).|
1716296|NCT00761631|3158038|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||2-Sided|95.0|0.8|1.12||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).|
1716297|NCT00761631|3158038|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||2-Sided|95.0|0.78|1.15||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).|
1716298|NCT00761631|3158038|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||2-Sided|95.0|1.24|1.8||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC Group 4 – 13vPnC Group 3).|
1717253|NCT00744380|3160318|Superiority or Other|||||||0.07|||||||Fisher Exact|||For delirium, new onset|
1716299|NCT00761137|3158140|Superiority or Other|||||||0.6|||||||ANOVA|||Primary outcome was analyzed by a mixed-effects ANOVA model employing “subject” as a random factor as well as “visit” and “treatment” as fixed factors. Intention-to-treat (ITT) sample was analyzed. Unweighted means and their 95% Confidence Interval (CI) are reported, which represent treatment group means adjusted for the effect of visit and removing the intra-subject variability. For all analyses, significance level was set at 5%.|
1716300|NCT00761085|3158141|Superiority||||||<|0.05|||||||ANOVA||||
1716301|NCT00761085|3158142|Other|No statistical comparisons||||||||||||||||"No statistical comparisons of methadone concentration in patients receiving methadone vs not receiving methadone (children or adults).~No statistical comparisons of methadone concentration in children vs adults"|No statistical comparisons
1716302|NCT00760877|3158152|Superiority or Other||Odds Ratio (OR)|2.096||||0.1083|2-Sided|95.0|0.766|5.738|||Cochran-Mantel-Haenszel||||
1716303|NCT00760747|3158161|Superiority or Other||Least square mean differences at week 2|-0.1|Standard Error of the Mean|1.4||0.927|2-Sided|95.0|-2.9|2.6|||Mixed Models Analysis||||
1716304|NCT00760747|3158166|Superiority or Other||Least square mean differences at week 10|0.0|Standard Error of the Mean|0.2||0.898|2-Sided|95.0|-0.4|0.4|||Mixed Models Analysis||||
1716305|NCT00760747|3158167|Superiority or Other||Least square mean differences at week 10|0.1|Standard Error of the Mean|0.2||0.526|2-Sided|95.0|-0.3|0.6|||Mixed Models Analysis||||
1716306|NCT00760747|3158168|Superiority or Other||Least square mean differences at week 10|0.2|Standard Error of the Mean|0.3||0.517|2-Sided|95.0|-0.3|0.7|||Mixed Models Analysis||||
1716307|NCT00760747|3158169|Superiority or Other||Least square mean differences at week 10|0.2|Standard Error of the Mean|0.2||0.456|2-Sided|95.0|-0.3|0.7|||Mixed Models Analysis||||
1716308|NCT00760747|3158170|Superiority or Other||Least square mean differences at week 10|-0.7|Standard Error of the Mean|1.7||0.692|2-Sided|95.0|-4.0|2.6|||Mixed Models Analysis||||
1716309|NCT00760513|3158223|Superiority||Mean Difference (Net)|-0.03||||0.9|2-Sided|95.0|-0.4|0.3||A priori threshold for statistical significance p </=0.05|Regression, Linear|Adjusted for baseline measurement.||There was no power calculation for this end point.|
1716310|NCT00760513|3158224|Superiority||Mean Difference (Net)|-0.001||||1|2-Sided|95.0|-0.3|0.3||A priori p value threshold </=0.5|Regression, Linear|Adjusted for baseline||Based on the available evidence at the time, we assumed that a 0.6-1.0 unit change in fibrosis score might be clinically significant (Hepatology 2008 Feb;47(2):455-460). Consequently, to detect a minimum 0.6 unit change in score (e.g. 9.0 at baseline and 8.4 at the end of the study) with an SD of 1.0, 100 participants would provide >80% power at the 5% significance level, and with a 15% drop out of participants there would also be >80% power to detect this effect.|
1716311|NCT00760513|3158225|Superiority||Mean Difference (Net)|-1.7||||0.48|2-Sided|95.0|-6.3|3.0||The a priori threshold for statistical significance = P</=0.05|Regression, Linear|Adjusted for baseline value of liver fat percentage||We estimated that a 20% decrease in liver fat with Omacor treatment, assuming a sigma of 0.3, and an alpha of 0.05; with 91 participants completing our trial, we had 86% power to detect a 20% change in liver fat (two tailed test) (see HEPATOLOGY 2014;60:1211-1221).|
1716312|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.012||||0.7647|2-Sided|95.0|-0.0698|0.093||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Precuneus|
1716313|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.008||||0.8191|2-Sided|95.0|-0.0843|0.0678||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_Thalamus|
1716314|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.085||||0.2186|2-Sided|95.0|-0.2262|0.0565||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_S1|
1716315|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.057||||0.3379|2-Sided|95.0|-0.0659|0.1795||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_Putamen|
1716316|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.0||||0.9958|2-Sided|95.0|-0.1398|0.1391||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_Premotor|
1716317|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.065||||0.5668|2-Sided|95.0|-0.3019|0.1722||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Superior Temporal|
1716318|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.002||||0.949|2-Sided|95.0|-0.0815|0.0767||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_Precuneus_base|
1716319|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.0||||0.9929|2-Sided|95.0|-0.0885|0.0893||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_Precuneus|
1716320|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.081||||0.3136|2-Sided|95.0|-0.2484|0.0856||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_Posterior Cingulate|
1716321|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.052||||0.4605|2-Sided|95.0|-0.0956|0.2004||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_pIns|
1716322|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.087||||0.0813|2-Sided|95.0|-0.0123|0.1863||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_pIns|
1716323|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.022||||0.6544|2-Sided|95.0|-0.0829|0.1278||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L_PAG|
1716324|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.01||||0.9182|2-Sided|95.0|-0.1912|0.2109||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_Orbito Front|
1716325|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.012||||0.7752|2-Sided|95.0|-0.0991|0.0754||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_Mid Temporal Pole|
1716326|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.094||||0.1562|2-Sided|95.0|-0.2296|0.0407||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_Mid Front_DLPFC|
1716327|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.013||||0.8656|2-Sided|95.0|-0.1699|0.1446||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_Mid Insula|
1716328|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.044||||0.6851|2-Sided|95.0|-0.2697|0.1824||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_Insula_base|
1716329|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.027||||0.5822|2-Sided|95.0|-0.1303|0.0761||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_IPL_base|
1716330|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.023||||0.572|2-Sided|95.0|-0.061|0.1062||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_BA23_base|
1716331|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.153||||0.0968|2-Sided|95.0|-0.3365|0.0313||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_Amygdala|
1716332|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.078||||0.2376|2-Sided|95.0|-0.0573|0.2127||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_anIns|
1716333|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.105||||0.1369|2-Sided|95.0|-0.2481|0.0378||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||R_DLPFC|
1716334|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.127||||0.2823|2-Sided|95.0|-0.3704|0.1165||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L_S2|
1716335|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.044||||0.4443|2-Sided|95.0|-0.0752|0.1624||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L_Putamen|
1716336|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.027||||0.467|2-Sided|95.0|-0.0496|0.1028||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L_Precuneus|
1716337|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.049||||0.4291|2-Sided|95.0|-0.1792|0.0806||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L_Posterior Cingulate|
1716338|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.0||||0.994|2-Sided|95.0|-0.0855|0.0848||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Posterior Insula|
1716339|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.003||||0.9551|2-Sided|95.0|-0.1047|0.0992||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||PAG|
1716340|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.168||||0.2099|2-Sided|95.0|-0.1065|0.4434||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L_Orbito Front|
1716341|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.02||||0.72|2-Sided|95.0|-0.0964|0.1361||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L_Mid Temporal Pole|
1716342|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.111||||0.3813|2-Sided|95.0|-0.3745|0.1524||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L_Mid Insula|
1716343|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.025||||0.4609|2-Sided|95.0|-0.0947|0.0452||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L_DLPFC|
1716344|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.077||||0.0758|2-Sided|95.0|-0.1642|0.0092||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L_Cerebellum|
1716345|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.081||||0.2369|2-Sided|95.0|-0.2228|0.0599||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L_Amygdala|
1716346|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.029||||0.5151|2-Sided|95.0|-0.064|0.1219||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||L_anIns|
1716376|NCT00760214|3158266|Superiority or Other||Mean Difference (Final Values)|-3.43||||0.029|2-Sided|95.0|-6.5|-0.36||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716347|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.072||||0.2987|2-Sided|95.0|-0.2161|0.0714||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||BA40|
1716348|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|-0.079||||0.5181|2-Sided|95.0|-0.3356|0.1771||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||BA22|
1716349|NCT00760474|3158244|Superiority or Other||Least Squares (LS) Mean difference|0.032||||0.6347|2-Sided|95.0|-0.1081|0.1714||Significance was set at p <0.05.|Mixed Models Analysis|Mixed-effect repeated measure model included participant as a random effect; treatment, visit as fixed effects.||Anterior Cingulate|
1716350|NCT00760474|3158245|Superiority or Other|||||||0.309||||||Significance was set at p <0.05.|t-test, 2 sided|||Glx/Cr anterior insula|
1716351|NCT00760474|3158245|Superiority or Other|||||||0.897||||||Significance was set at p <0.05.|t-test, 2 sided|||Glx/Cr anterior insula|
1716352|NCT00760474|3158245|Superiority or Other|||||||0.937|||||||t-test, 2 sided|Significance was set at p <0.05.||Gln/Cr anterior insula|
1716353|NCT00760474|3158245|Superiority or Other|||||||0.96|||||||t-test, 2 sided|Significance was set at p <0.05.||Gln/Cr anterior insula|
1716354|NCT00760474|3158245|Superiority or Other|||||||0.154||||||Significance was set at p <0.05.|t-test, 2 sided|||Glu/Cr anterior insula|
1716355|NCT00760474|3158245|Superiority or Other|||||||0.809||||||Significance was set at p <0.050.|t-test, 2 sided|||Glu/Cr anterior insula|
1716356|NCT00760474|3158245|Superiority or Other||Mean Difference (Final Values)|0.029|Standard Deviation|0.308||0.708||||||Significance was set at p <0.05.|t-test, 2 sided||Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glx/Cr posterior insula|
1716357|NCT00760474|3158245|Superiority or Other||Mean Difference (Final Values)|-0.116|Standard Deviation|0.177||0.016|||||||t-test, 2 sided|Significance was set at p <0.05.|Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glx/Cr posterior insula|
1716358|NCT00760474|3158245|Superiority or Other|||||||0.809|||||||t-test, 2 sided|Significance was set at p <0.05.||Gln/Cr posterior insula|
1716359|NCT00760474|3158245|Superiority or Other|||||||0.306|||||||t-test, 2 sided|Significance was set at p <0.05.||Gln/Cr posterior insula|
1716360|NCT00760474|3158245|Superiority or Other|||||||0.436||||||Significance was set at p <0.05.|t-test, 2 sided|||Glu/Cr posterior insula|
1716361|NCT00760474|3158245|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Deviation|0.157||0.083||||||Significance was set at p <0.05.|t-test, 2 sided||Mean difference between the pre-dose (baseline) and post-dose values calculated as post-dose minus pre-dose (post minus pre).|Glu/Cr posterior insula|
1716362|NCT00760214|3158259|Superiority or Other||Mean Difference (Final Values)|-5.32|||<|0.001|2-Sided|95.0|-7.81|-2.82||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716363|NCT00760214|3158259|Superiority or Other||Mean Difference (Final Values)|-5.68|||<|0.001|2-Sided|95.0|-8.19|-3.17||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716364|NCT00760214|3158260|Superiority or Other||Mean Difference (Final Values)|-8.2|||<|0.001|2-Sided|95.0|-11.46|-4.95||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716365|NCT00760214|3158260|Superiority or Other||Mean Difference (Final Values)|-8.87|||<|0.001|2-Sided|95.0|-12.15|-5.6||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716366|NCT00760214|3158261|Superiority or Other||Mean Difference (Final Values)|-3.77|||<|0.001|2-Sided|95.0|-5.89|-1.65||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716367|NCT00760214|3158261|Superiority or Other||Mean Difference (Final Values)|-3.01|||<|0.006|2-Sided|95.0|-5.15|-0.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716368|NCT00760214|3158262|Superiority or Other||Mean Difference (Final Values)|-5.82|||<|0.001|2-Sided|95.0|-8.96|-2.67||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716369|NCT00760214|3158262|Superiority or Other||Mean Difference (Final Values)|-5.95|||<|0.001|2-Sided|95.0|-9.12|-2.77||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716370|NCT00760214|3158263|Superiority or Other||Mean Difference (Final Values)|-2.98||||0.003|2-Sided|95.0|-4.93|-1.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716371|NCT00760214|3158263|Superiority or Other||Mean Difference (Final Values)|-2.64||||0.008|2-Sided|95.0|-4.6|-0.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716372|NCT00760214|3158264|Superiority or Other||Mean Difference (Final Values)|-4.26||||0.004|2-Sided|95.0|-7.18|-1.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716373|NCT00760214|3158264|Superiority or Other||Mean Difference (Final Values)|-4.53||||0.003|2-Sided|95.0|-7.46|-1.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716374|NCT00760214|3158265|Superiority or Other||Mean Difference (Final Values)|-2.42||||0.022|2-Sided|95.0|-4.49|-0.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716375|NCT00760214|3158265|Superiority or Other||Mean Difference (Final Values)|-2.06||||0.052|2-Sided|95.0|-4.15|0.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716377|NCT00760214|3158266|Superiority or Other||Mean Difference (Final Values)|-3.77||||0.017|2-Sided|95.0|-6.87|-0.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716378|NCT00760214|3158267|Superiority or Other||Mean Difference (Final Values)|-3.06||||0.001|2-Sided|95.0|-4.89|-1.24||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716379|NCT00760214|3158267|Superiority or Other||Mean Difference (Final Values)|-2.77||||0.003|2-Sided|95.0|-4.61|-0.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716380|NCT00760214|3158268|Superiority or Other||Mean Difference (Final Values)|-4.47||||0.002|2-Sided|95.0|-7.27|-1.66||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716381|NCT00760214|3158268|Superiority or Other||Mean Difference (Final Values)|-4.82|||<|0.001|2-Sided|95.0|-7.64|-2.01||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716382|NCT00760214|3158269|Superiority or Other||Mean Difference (Final Values)|-5.66|||<|0.001|2-Sided|95.0|-7.21|-4.12||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716383|NCT00760214|3158269|Superiority or Other||Mean Difference (Final Values)|-5.31|||<|0.001|2-Sided|95.0|-6.85|-3.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented.|ANCOVA||||
1716384|NCT00760214|3158270|Superiority or Other||Mean Difference (Final Values)|-9.03|||<|0.001|2-Sided|95.0|-11.66|-6.39||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1716385|NCT00760214|3158270|Superiority or Other||Mean Difference (Final Values)|-8.41|||<|0.001|2-Sided|95.0|-11.04|-5.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1716386|NCT00759954|3158280|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p < 0.05.|mean ratio|98.1|||<|0.05||90.0|94.2|102.1|||ANOVA||||
1716387|NCT00759954|3158281|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p < 0.05.|mean ratio|95.82|||<|0.05||90.0|92.93|98.8|||ANOVA|Analysis of Variance for the log-transformed AUC. The 90% confidence interval for the ratio of AUC(Test)/AUC(Ref) is provided.|||
1716388|NCT00759954|3158283|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated. The Wilcoxon signed rank test was used for a nonparametric comparison of Tmax values and a significant difference was defined a priori as p < 0.05.|mean ratio|97.19|||<|0.05||90.0|91.31|103.45|||ANOVA||||
1716389|NCT00759915|3158288|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|96.5||||||90.0|92.3|100.97|||||||
1716390|NCT00759915|3158289|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|100.91||||||90.0|96.96|105.0|||||||
1716391|NCT00759915|3158291|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|109.98||||||90.0|100.1|120.8|||||||
1716392|NCT00759902|3158292|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|102.9||||||90.0|99.3|106.5|||||||
1716393|NCT00759902|3158293|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.7||||||90.0|98.5|104.9|||||||
1716394|NCT00759902|3158295|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|123.0||||||90.0|112.9|134.1|||||||
1716395|NCT00759772|3158309|Superiority||||||<|0.01||||||Calculated p-value.|t-test, 2 sided||||
1716396|NCT00759759|3158310|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.3||||||90.0|96.2|106.7|||||||
1716397|NCT00759759|3158311|Non-Inferiority or Equivalence|ANOVA performed on the ratio of geometric means|mean ratio|101.1||||||90.0|96.9|105.4||||||Statistical analysis of ln-transformed plasma morphine AUClast|
1716398|NCT00759759|3158313|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|90.46||||||90.0|82.9|98.7||||||ANOVA of ln-transformed plasma morphine Cmax|
1716435|NCT00758836|3158422|Superiority or Other||Proportion difference|20.4|||<|0.001|2-Sided|90.0|12.6|28.2|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.|||
1717254|NCT00744380|3160318|Superiority or Other||||||>|0.1|||||||Fisher Exact|||For tachycardia|
1716399|NCT00759681|3158315|Non-Inferiority or Equivalence|Safety was evaluated using non-inferiority hypothesis evaluating the proportion of cases with any instance of sign. bleeding, neurological deficit or immune/inflammatory allergic response. Safety based on one-tailed, 0.05 alpha, with equivalence limit set at 15%.|Mean Difference (Final Values)|-0.135|Standard Error of the Mean|0.0671||0.05|1-Sided|95.0||-0.003|||Exact binomial confidence limit|Safety: 95% confidence limits of the difference between groups, and ensuring that the upper limit of the difference was less than or equal to 15%.|The cumulative incidence of safety endpoints for the Investigational Treatment group was an average of 13.5% less than for the Control group.|The mean difference is equivalent to the proportion of Investigational Device patients minus the proportion of Control patients experiencing any instance of significant bleeding, neurological deficit or immune/inflammatory allergic response.|
1716400|NCT00759681|3158316|Superiority or Other||Mean Difference (Final Values)|0.208|Standard Error of the Mean|0.0538||0.05|2-Sided|95.0|0.103|0.314|||Exact binomial confidence limit|Effectiveness: 95% confidence limits of the difference between groups, and ensuring that the lower limit of the difference was greater than 10%.||Effectiveness was evaluated using a superiority hypothesis, comparing treatment sites with regards to the proportion achieving immediate suture line sealing between the groups. Effectiveness was based on a two-tailed, 0.05 hypothesis test, with a minimum effect size set at 10%. The mean difference in the proportion of sites achieving immediate suture line sealing was compared between the Control and Investigation Device groups.|
1716401|NCT00759564|3158351|Superiority or Other||Percent Geometric Mean Ratio|735.77|||||2-Sided|90.0|523.56|1034.0||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716402|NCT00759564|3158351|Superiority or Other||Percent Geometric Mean Ratio|353.26|||||2-Sided|90.0|267.57|466.39||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716403|NCT00759564|3158351|Superiority or Other||Percent Geometric Mean Ratio|209.55|||||2-Sided|90.0|158.72|276.66||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716404|NCT00759564|3158352|Superiority or Other||Percent Geometric Mean Ratio|742.68|||||2-Sided|90.0|529.59|1041.5||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716405|NCT00759564|3158352|Superiority or Other||Percent Geometric Mean Ratio|353.0|||||2-Sided|90.0|267.83|465.25||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716406|NCT00759564|3158352|Superiority or Other||Percent Geometric Mean Ratio|209.31|||||2-Sided|90.0|158.81|275.87||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716407|NCT00759564|3158354|Superiority or Other||Percent Geometric Mean Ratio|285.05|||||2-Sided|90.0|221.8|366.33||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716408|NCT00759564|3158354|Superiority or Other||Percent Geometric Mean Ratio|226.28|||||2-Sided|90.0|184.36|277.72||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716409|NCT00759564|3158354|Superiority or Other||Percent Geometric Mean Ratio|134.86|||||2-Sided|90.0|109.88|165.52||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716410|NCT00759564|3158356|Superiority or Other||Percent Geometric Mean Ratio|110.12|||||2-Sided|90.0|89.84|134.98||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716411|NCT00759564|3158356|Superiority or Other||Percent Geometric Mean Ratio|248.38|||||2-Sided|90.0|202.98|303.94||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1717255|NCT00744380|3160318|Superiority or Other||||||>|0.1|||||||Chi-squared, Corrected|||For bradycardia|
1716412|NCT00759564|3158356|Superiority or Other||Percent Geometric Mean Ratio|168.14|||||2-Sided|90.0|137.4|205.75||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUCinf for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716413|NCT00759564|3158357|Superiority or Other||Percent Geometric Mean Ratio|107.13|||||2-Sided|90.0|88.06|130.32||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716414|NCT00759564|3158357|Superiority or Other||Percent Geometric Mean Ratio|246.76|||||2-Sided|90.0|202.11|301.27||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716415|NCT00759564|3158357|Superiority or Other||Percent Geometric Mean Ratio|167.59|||||2-Sided|90.0|137.27|204.61||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed AUClast for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716416|NCT00759564|3158359|Superiority or Other||Percent Geometric Mean Ratio|58.4|||||2-Sided|90.0|48.16|70.83||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for severe renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716417|NCT00759564|3158359|Superiority or Other||Percent Geometric Mean Ratio|163.51|||||2-Sided|90.0|139.72|191.34||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for moderate renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716418|NCT00759564|3158359|Superiority or Other||Percent Geometric Mean Ratio|124.71|||||2-Sided|90.0|106.57|145.94||||||A one-way ANOVA model with group as a fixed effect was used to compare the natural log transformed Cmax for mild renal impairment group (Test) to normal renal function group (Reference). The adjusted mean differences and 90% confidence intervals (CIs) for the differences were exponentiated to provide estimates of the ratio of adjusted geometric means (Test/Reference) and 90% CIs for the ratios.|
1716419|NCT00759356|3158371|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.7||||||90.0|95.9|107.9|||||||
1716420|NCT00759356|3158372|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|mean ratio|101.5||||||90.0|95.6|107.9|||||||
1716421|NCT00759356|3158374|Non-Inferiority or Equivalence|The 90% confidence intervals for the ratios (test/reference) of the least squares means of the non-transformed parameters Cmax, AUClast, AUCinf, Tmax, λz, and T1/2, were calculated.|Mean ratio|109.8||||||90.0|95.3|126.5|||||||
1716422|NCT00759187|3158385|Superiority or Other||||||<|0.05||||||Two way Anova general linear model (subject and treatment as factors)|ANOVA||||
1716423|NCT00759174|3158386|Superiority or Other||Odds Ratio (OR)|3.61|||<|0.001|2-Sided|95.0|1.7|7.69|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.|
1716424|NCT00759174|3158387|Superiority or Other||Odds Ratio (OR)|2.36||||0.003|2-Sided|95.0|1.33|4.19|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.|
1716425|NCT00759174|3158388|Superiority or Other||Odds Ratio (OR)|2.15||||0.033|2-Sided|95.0|1.06|4.34|||Conditional logistic regression|||Conditional logistic regression was stratified by participant.|
1716426|NCT00759161|3158394|Superiority or Other||||||<|0.001|||||||2-sided sign test||||
1716427|NCT00759031|3158405|Superiority or Other|||||||0.05|||||||ANOVA|||The null hypothesis states that there is no difference between groups.|
1716428|NCT00758836|3158421|Superiority or Other||Proportion difference|34.7|||<|0.001|2-Sided|90.0|25.3|43.4|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.|||
1716429|NCT00758836|3158421|Superiority or Other||Proportion difference|5.2|||<|0.362|2-Sided|90.0|-4.2|14.5|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.|||
1716430|NCT00758836|3158421|Superiority or Other||Proportion difference|6.1|||<|0.265|2-Sided|90.0|-2.9|14.9|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.|||
1716431|NCT00758836|3158421|Superiority or Other||Proportion difference|39.9|||<|0.001|2-Sided|90.0|30.5|48.5|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.|||
1716432|NCT00758836|3158421|Superiority or Other||Proportion difference|40.8|||<|0.001|2-Sided|90.0|31.9|49.0|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.|||
1716433|NCT00758836|3158422|Superiority or Other||Proportion difference|7.7||||0.182|2-Sided|90.0|-1.8|17.1|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.|||
1716434|NCT00758836|3158422|Superiority or Other||Proportion differenece|4.2||||0.449|2-Sided|90.0|-5.0|13.3|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.|||
1716436|NCT00758836|3158422|Superiority or Other||Proportion difference|27.7|||<|0.001|2-Sided|90.0|19.6|35.8|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomal distribution stratified by baseline severity.|||
1716437|NCT00758836|3158422|Superiority or Other||Proportion difference|24.5|||<|0.001|2-Sided|90.0|16.7|32.2|||Miettinen and Nurminen|Miettinen and Nurminen method for independent binomial distribution stratified by baseline severity.|||
1716438|NCT00758680|3158444|Superiority or Other||LS Mean Difference on Last Dosing Day|92.3|||<|0.001|2-Sided|95.0|67.56|117.04|||Mixed Effect Model||||
1716439|NCT00758680|3158444|Superiority or Other||LS Mean Difference on Last Dosing Day|37.63|||<|0.015|2-Sided|95.0|12.58|62.68|||Mixed Effect Model||||
1716440|NCT00758602|3158450|Superiority or Other|||||||1|||||||Fisher Exact||||
1716441|NCT00758602|3158451|Superiority or Other|||||||0.4586|||||||Fisher Exact||||
1716442|NCT00758602|3158452|Superiority or Other|||||||1|||||||Log Rank||||
1716443|NCT00758602|3158454|Superiority or Other|||||||1|||||||Fisher Exact|||Death, 12 months post-transplant|
1716444|NCT00758602|3158454|Superiority or Other|||||||0.6812|||||||Fisher Exact|||Acute rejection, 12 months post-transplant|
1716445|NCT00758602|3158454|Superiority or Other|||||||0.6812|||||||Fisher Exact|||Acute rejection, 6 months post-transplant|
1716446|NCT00758602|3158455|Superiority or Other||LS Mean difference|-1.5977||||0.7949|2-Sided|95.0|-13.77|10.58||p-value, LS mean difference, and 95% CI based on ANCOVA model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.|ANCOVA||||
1716447|NCT00758602|3158456|Superiority or Other||LS Mean difference|0.6581||||0.0813|2-Sided|95.0|-0.08|1.4||p-value, least squares (LS) mean difference, and 95% confidence interval (CI) based on analysis of covariance (ANCOVA) model with treatment, center, and the treatment-by-center interaction as fixed effects, and the donor age as a covariate.|ANCOVA||||
1716448|NCT00758563|3158475|Superiority or Other|||||||0.05|||||||ANOVA||||
1716449|NCT00758498|3158486|Superiority or Other|||||||0.8112|||||||ANOVA||||
1716450|NCT00758498|3158486|Superiority or Other|||||||0.1038|||||||ANOVA||||
1716451|NCT00758498|3158487|Superiority or Other|||||||0.3539|||||||ANOVA||||
1716452|NCT00758498|3158487|Superiority or Other|||||||0.9595|||||||ANOVA||||
1716453|NCT00758498|3158488|Superiority or Other|||||||0.004|||||||ANOVA||||
1716454|NCT00758498|3158488|Superiority or Other|||||||0.8262|||||||ANOVA||||
1716455|NCT00758498|3158490|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is from an ANCOVA with treatment as a factor and the baseline value as a covariate|||
1716456|NCT00758498|3158490|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons are from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|||
1716457|NCT00758498|3158491|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on ANCOVA with treatment as a factor and the baseline value as a covariate|||
1716458|NCT00758498|3158491|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate|||
1716459|NCT00758498|3158492|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on ANCOVA with treatment as factor and baseline value as a covariate|||
1716460|NCT00758498|3158492|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as factor and baseline value as a covariate.|||
1716461|NCT00758498|3158498|Superiority or Other|||||||0.0033|||||||ANCOVA|Analysis of treatment comparisons was based on ANCOVA with treatment as a factor and the baseline as a covariate|||
1716462|NCT00758498|3158498|Superiority or Other|||||||0.0022|||||||ANCOVA|Analysis of treatment comparisons is based on analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate|||
1716463|NCT00758498|3158499|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis of treatment comparisons is based on an ANCOVA with treatment as a factor and baseline value as a covariate|||
1716464|NCT00758498|3158499|Superiority or Other||||||<|0.0001||||||Analysis of treatment comparisons is based on an analysis of variance (ANCOVA) with treatment as a factor and the baseline value as covariate|ANCOVA||||
1716465|NCT00758498|3158500|Superiority or Other||||||<|0.0001|||||||ANCOVA|Analysis by ANCOVA with treatment as a factor and the baseline value as a covariate|||
1716466|NCT00758498|3158500|Superiority or Other||||||<|0.0012|||||||ANCOVA|Treatment comparisons made use of an analysis of covariance (ANCOVA) analysis with treatment as a factor and baseline value as a covariate|||
1716467|NCT00758498|3158501|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1716468|NCT00758498|3158501|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1716469|NCT00758498|3158502|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.0441|2-Sided|95.0|-0.5|-0.05|||ANCOVA||||
1716470|NCT00758498|3158502|Superiority or Other||Mean Difference (Final Values)|0.0||||0.8341|2-Sided|95.0|-0.2|0.25|||ANOVA||||
1716471|NCT00758498|3158503|Superiority or Other||Mean Difference (Final Values)|6.9|||<|0.0001|2-Sided|95.0|6.06|7.69|||ANCOVA|Treatment was a factor and baseline value was a co-variate|||
1716472|NCT00758498|3158503|Superiority or Other||Mean Difference (Final Values)|2.9|||<|0.0001|2-Sided|95.0|2.07|3.71|||ANCOVA|Treatment was a factor and baseline value was a co-variate|||
1716473|NCT00758394|3158522|Superiority or Other||||||<|0.05||||||Two way Anova general linear model (subject and treatment as factors). Multiple comparison completed to determine differences between groups.|ANOVA|||The null hypothesis states that there is no difference between groups.|
1716474|NCT00758290|3158524|Superiority or Other|||||||0.05|||||||ANOVA||||
1716521|NCT00757237|3158665|Superiority or Other|||||||0.0025||||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for IV antipseudomonal antibiotics for respiratory events.|
1716475|NCT00758264|3158541|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup Y (rSBA-MenY) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|0.0|||||2-Sided|95.0|-2.18|4.6||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup Y (rSBA-MenY).|
1716476|NCT00758264|3158541|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup W-135 (rSBA-MenW-135) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|1.25|||||2-Sided|95.0|-0.94|6.76||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup W-135 (rSBA-MenW-135).|
1716477|NCT00758264|3158541|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup C (rSBA-MenC) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|0.68|||||2-Sided|95.0|-2.11|6.22||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup C (rSBA-MenC).|
1716478|NCT00758264|3158541|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference in percentage of subjects with serum bactericidal antibody using baby rabbit complement against Neisseria meningitides serogroup A (rSBA-MenA) titer ≥ 1:8 (Nimenrix + Synflorix Group minus Nimenrix Group) is ≥ -10%.|Difference in percentage|1.93|||||2-Sided|95.0|-1.09|8.15||||||Demonstration of non-inferiority of Nimenrix conjugate vaccine when co-administered with Synflorix vaccine versus Nimenrix conjugate vaccine given alone (Synflorix vaccine was administered 1 month later) in terms of serum bactericidal assay using rabbit complement against Neisseria meningitides serogroup A (rSBA-MenA).|
1716479|NCT00758264|3158542|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (>) 0.5.|Adjusted GMC ratio|1.07|||||2-Sided|95.0|0.83|1.38||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 23F antibody concentrations.|
1716480|NCT00758264|3158542|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (>) 0.5.|Adjusted GMC ratio|0.86|||||2-Sided|95.0|0.68|1.08||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 19F antibody concentrations.|
1716481|NCT00758264|3158542|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (>) 0.5.|Adjusted GMC ratio|0.52|||||2-Sided|95.0|0.41|0.67||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 18C antibody concentrations.|
1716482|NCT00758264|3158542|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (>) 0.5.|Adjusted GMC ratio|0.98|||||2-Sided|95.0|0.78|1.23||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 14 antibody concentrations.|
1716483|NCT00758264|3158542|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (>) 0.5.|Adjusted GMC ratio|0.94|||||2-Sided|95.0|0.78|1.14||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 9V antibody concentrations.|
1716484|NCT00758264|3158542|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (>) 0.5.|Adjusted GMC ratio|1.0|||||2-Sided|95.0|0.84|1.2||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 7F antibody concentrations.|
1716485|NCT00758264|3158542|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (>) 0.5.|Adjusted GMC ratio|0.84|||||2-Sided|95.0|0.66|1.07||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 6B antibody concentrations.|
1716486|NCT00758264|3158542|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (>) 0.5.|Adjusted GMC ratio|0.9|||||2-Sided|95.0|0.74|1.1||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 5 antibody concentrations.|
1716487|NCT00758264|3158542|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (>) 0.5.|Adjusted GMC ratio|1.03|||||2-Sided|95.0|0.84|1.26||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 4 antibody concentrations.|
1716488|NCT00758264|3158542|Non-Inferiority|Non-inferiority was demonstrated if the lower limit (LL) of the 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Nimenrix +Synflorix Group and the Synflorix Group (Nimenrix + Synflorix Group over Synflorix Group) is above (>) 0.5.|Adjusted GMC ratio|0.87|||||2-Sided|95.0|0.72|1.05||||||Demonstration of non-inferiority of Synflorix vaccine when co-administered with Nimenrix conjugate vaccine versus Synflorix vaccine given alone (Nimenrix conjugate vaccine was administered 1 month later) in terms of anti-pneumococcal serotype 1 antibody concentrations.|
1716489|NCT00758069|3158555|Superiority or Other||Least-squares Mean Difference|-12.9|||<|0.001||95.0|-20.4|-5.4||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval||
1716490|NCT00758069|3158555|Superiority or Other||Least-squares Mean Difference|-19.3|||<|0.001||95.0|-26.6|-11.9||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval||
1716491|NCT00758069|3158556|Superiority or Other||Least-squares Mean Difference|-19.5|||<|0.001||95.0|-28.0|-11.1||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval||
1716492|NCT00758069|3158556|Superiority or Other||Least-squares Mean Difference|-25.9|||<|0.001||95.0|-34.2|-17.5||No multiplicity adjustment among the pairwise comparisons of sitagliptin against placebo|ANCOVA|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used for pairwise comparison|ANCOVA model with terms of treatment as a factor and baseline value as a covariate was used to estimate difference of two groups and its 95% confidence interval||
1716493|NCT00758043|3158563|Non-Inferiority or Equivalence|Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).|Odds Ratio, log|0.94|||||2-Sided|95.0|0.49|1.82|||||||
1716494|NCT00758043|3158563|Non-Inferiority or Equivalence|Estimated by evaluating the treatment differences in the SVR at Week 72 planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of 10.5%).|Difference in Proportion|-0.5|||||2-Sided|95.0|-7.7|6.8|||||||
1716495|NCT00758043|3158564|Non-Inferiority or Equivalence|Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).|Difference in proportions|2.0|||||2-Sided|95.0|-4.3|8.2||||||SVR24 was defined as below the limit of quantitation at 24 weeks after the planned end of treatment. For subjects who had missing data at week 24 after the planned end of treatment, the week 12 data or the last follow-up time point after week 12 was carried forward for determining SVR24.|
1716496|NCT00758043|3158564|Non-Inferiority or Equivalence|Estimated by evaluating the treatment differences in the SVR24planned rates (T12PR24/eRVR+ minus T12PR48/eRVR+) and the 95% CI for these groups (the entire 2 sided CI is to the right of the predefined non-inferiority margin of -10.5%).|Difference in proportions|4.5|||||2-Sided|95.0|-2.1|11.1||||||Primary efficacy analysis was based on CI estimates (using the normal approximation, confidence limits were constructed for the difference in proportions) to rule out the inferiority of the T12/PR24/eRVR+ treatment regimen relative to the T12/PR48/eRVR+ treatment regimen. SVR24 was defined as undetectable HCV RNA at end of treatment through 24 weeks after the last planned dose.|
1716497|NCT00757822|3158585|Superiority or Other||||||>|0.55|||||||FREQ Procedure|||Comparisons of both arms at 2-6 weeks.|
1716498|NCT00757822|3158585|Superiority or Other||||||>|0.29|||||||FREQ procedure|||Comparison of both group responses at 24-48 hours.|
1716499|NCT00757822|3158586|Superiority or Other||||||>|0.1|||||||FREQ procedure|||Comparisons of both arms at 2-6 weeks; null hypothesis: dronabinol is not superior to ondansetron in patient satisfaction|
1716500|NCT00757822|3158586|Superiority or Other||||||>|0.75|||||||FREQ Procedure|||Comparisons at 24-48 hr post-surgery. Null hypothesis: dronabinol is not superior to ondansetron in patient satisfaction.|
1716501|NCT00757822|3158587|Superiority or Other||||||>|0.37|||||||Fisher Exact||||
1716502|NCT00757822|3158588|Superiority or Other||||||>|0.9|||||||Fisher Exact||||
1716503|NCT00757822|3158589|Superiority or Other||||||=|0|||||||Wilcoxon Rank-Sum test||||
1716504|NCT00757822|3158590|Superiority or Other||Difference in Percentages|7.7|||>|0.55|2-Sided|90.0|-12.1|13.3|||Fisher Exact||||
1716505|NCT00757822|3158591|Superiority or Other||||||>|0.92|||||||Fisher Exact|One-sided Fisher's Exact test was performed comparing the percentage of subjects with at least one VAS score > 0. (Marinol>Ondansetron).|||
1716506|NCT00757822|3158592|Superiority or Other||Difference in Percentages|4.6|||>|0.76|2-Sided|90.0|-9.5|18.6|||Fisher Exact|||The incidence of PON per arm will be determined and expressed as a percentage of the total patients per arm. Treatment efficacy will be measured as the percentage-point decrease in PON in the treatment arm (Marinol) compared to the standard therapy arm (ondansetron). Null hypothesis: Marinol treatment is not superior to ondansetron treatment. We will test the statistical significance with Fisher's Exact test at a significance level of 0.05|
1716507|NCT00757601|3158637|Non-Inferiority or Equivalence|"To assess the effect of food at the 30 mg dose, a point estimate was constructed for the geometric mean ratio for the fed/fasted states (GMR[fed/fasted]) of MK1006 Cmax.~The GMR (fed/fasted) was calculated using the geometric mean Cmax of the fed state divided by the geometric mean Cmax fasted state.~A GMR (fed/fasted) point estimate value within 20% of unity (1.00) was considered consistent with an absence of a clinically significant food effect."|Geometric Mean Ratio (fed/fasted)|1.14||||||95.0||||||||A linear mixed-effect model was used to estimate the geometric mean Cmax for MK1006 at every dose level.|
1716508|NCT00757601|3158638|Non-Inferiority or Equivalence|"To assess the effect of food at the 30 mg dose, a point estimate was constructed for the geometric mean ratio for the fed/fasted states (GMR[fed/fasted]) of MK1006 AUC (0-∞).~The GMR (fed/fasted) was calculated using the geometric mean AUC (0-∞) of the fed state divided by the geometric mean AUC (0-∞) fasted state.~A GMR (fed/fasted) point estimate value within 20% of unity (1.00) was considered consistent with an absence of a clinically significant food effect."|Geometric Mean Ratio (fed/fasted)|1.03||||||95.0||||||||A linear mixed-effect model was used to estimate the geometric mean AUC (0-∞) for MK1006 at every dose level.|
1716509|NCT00757588|3158648|Superiority or Other||Mean Difference (Final Values)|-3.3|Standard Error of the Mean|1.16|||2-Sided|95.0|-5.6|-1.1|||||ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use||
1716510|NCT00757588|3158650|Superiority or Other||Mean Difference (Final Values)|-4.02|Standard Error of the Mean|4.732||0.3958|2-Sided|95.0|-13.32|5.28||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use||
1716511|NCT00757588|3158651|Superiority or Other||Mean Difference (Final Values)|-23.0|Standard Error of the Mean|7.24||0.0016|2-Sided|95.0|-37.2|-8.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use||
1716512|NCT00757588|3158652|Superiority or Other||Mean Difference (Final Values)|-3829.8|Standard Error of the Mean|1165.99||0.0011|2-Sided|95.0|-6122.4|-1537.1||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use||
1716513|NCT00757588|3158653|Superiority or Other||Mean Difference (Final Values)|-0.41|Standard Error of the Mean|0.089|<|0.0001|2-Sided|95.0|-0.59|-0.24||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment + metformin use||
1716514|NCT00757237|3158658|Superiority or Other|||||||0.0004||||||No adjustments were made for multiple comparisons.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to need for inhaled and/or IV antipseudomonal antibiotics for respiratory events.|
1716515|NCT00757237|3158659|Superiority or Other|||||||0.004||||||No adjustments were made for multiple comparisons.|negative binomial regression method|||Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory events requiring IV and/or inhaled antipseudomonal antibiotics (other than randomized treatment) from Day 0 to Day 168 (end of study).|
1716516|NCT00757237|3158660|Superiority or Other|||||||0.044||||||No adjustments were made for multiple comparisons.|negative binomial regression method|||Null hypothesis: there was no difference between AZLI and TIS treatment groups in the total number of respiratory hospitalizations from Day 0 to Day 168 (end of study).|
1716517|NCT00757237|3158661|Superiority or Other||Mean Difference (Final Values)|-14.12||||0.0097||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the global satisfaction results of the TSQM at Week 20 (Day 140).|
1716518|NCT00757237|3158662|Superiority or Other||Mean Difference (Final Values)|-4.13||||0.0189||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the average actual change in respiratory symptoms at the end of each treatment course (Weeks 4, 12, and 20).|
1716519|NCT00757237|3158663|Superiority or Other||Mean Difference (Final Values)|-5.61||||0.0048||0.0||||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, Day 0 CFQ-R RSS score, and previous inhaled tobramycin use.|Treatment difference refers to TIS-AZLI.|Null hypothesis: there was no difference between AZLI and TIS treatment groups in change from baseline in CFQ-R RSS scores at Day 28.|
1716520|NCT00757237|3158664|Superiority or Other|||||||0.1114||||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|Log Rank|||Null hypothesis: there was no difference between AZLI and TIS treatment groups with respect to time to first respiratory hospitalization.|
1716542|NCT00756002|3158803|Superiority or Other|||||||0.111||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716522|NCT00757237|3158666|Superiority or Other||Mean Difference (Final Values)|-3.47||||0.0002||||||Secondary endpoints were tested sequentially to control the Type I error rate based on the closed testing procedure. Given the significance of the coprimary endpoints and previous secondary endpoint, this endpoint was also tested at the 0.05 level.|MMRM analysis|MMRM analysis included treatment, Day 0 FEV1 percent predicted, visit, treatment, and treatment/visit interaction for all participants.|Treatment difference refers to TIS-AZLI|Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses in the stratum of subjects having >=84 days of inhaled tobramycin use in the previous 12 months.|
1716523|NCT00757237|3158667|Non-Inferiority or Equivalence|The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.|Mean Difference (Final Values)|-9.5|||<|0.0001|2-Sided|95.0|-13.86|-5.14||Secondary endpoints were tested sequentially by the closed testing procedure initiated by the significance of the primary endpoints. Given the coprimary endpoints were met at the 0.05 level, this non-inferiority endpoint was tested at the 0.05 level.|ANCOVA|ANCOVA model included treatment and Day 0 FEV1 percent predicted.|Treatment difference refers to TIS-AZLI.|Null hypothesis: AZLI was inferior to TIS by more than 4% in terms of the participant means in relative change of FEV1 percent predicted at Day 28 among all participants having >= 84 days of inhaled tobramycin use in the previous 12 months.|
1716524|NCT00757237|3158668|Superiority or Other||Mean Difference (Final Values)|-2.7||||0.0023||||||Based on the Benjamini & Hochberg method, superiority at Weeks 4, 12, and 20 of actual change in FEV1 percent predicted was tested at the 0.05 level, given the significance of the coprimary endpoint (p<0.05).|MMRM analysis|MMRM analysis included Day 0 FEV1 percent predicted, previous inhaled tobramycin use, treatment, visit, and treatment/visit interaction.|Treatment difference refers to TIS-AZLI.|"Null hypothesis: there was no difference between AZLI and TIS treatment groups in the mean actual change of FEV1 percent predicted across 3 treatment courses among all participants.~With 120 subjects per treatment group, there was at least 90% power at a 5% significance level to detect differences based upon actual change from baseline in FEV1 percent predicted (3.61%, 2.98%, 2.32%) between AZLI and TIS at Weeks 4, 12, and 20 with a common standard deviation of 9%."|
1716525|NCT00757237|3158669|Non-Inferiority or Equivalence|The treatment difference (TIS-AZLI) and standard error from the ANCOVA model were used to compute the two-sided 95% confidence interval. If the 95% upper boundary was less than the pre-specified non-inferiority margin of 4%, then the null hypothesis was rejected.|Mean Difference (Final Values)|-7.8||||0.0001|2-Sided|95.0|-11.73|-3.86||Based on the Benjamini & Hochberg method, non-inferiority at Day 28 for relative change in FEV1 percent predicted was assessed at the 0.05 level, given the significance of the coprimary endpoint (p<0.05).|ANCOVA|ANCOVA model included treatment, Day 0 FEV1 percent predicted, and previous inhaled tobramycin use for all participants.|Treatment difference refers to TIS-AZLI.|Null hypothesis: AZLI was inferior to TIS by more than 4% in the mean relative change of FEV1 percent predicted at Day 28. With 120 subjects per treatment group there was at least 85% power to declare noninferiority based on relative change from baseline at Day 28 in FEV1 percent predicted using the upper bound of a 2-tailed 95% CI for the difference in means with a noninferiority margin of 4, assuming a common standard deviation of 18% and true difference in means [TIS-AZLI] of -3.2%.|
1716526|NCT00756938|3158692|Superiority or Other||Slope|1.81||||0.643|2-Sided|95.0|-5.9|9.51|||ANCOVA|Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage|||
1716527|NCT00756938|3158693|Superiority or Other||Slope|1.22||||0.753|2-Sided|95.0|-6.45|8.9|||ANCOVA|Analysis of covariance (ANCOVA) model with terms for dose, weight (as a continuous covariate) and presence of co-morbidities/end organ damage|||
1716528|NCT00756613|3158708|Equivalence|T-test comparing between the two groups of treatment using the average score of last two surveys.|Mean Difference (Final Values)|1.61||||0.172|2-Sided|95.0|||||t-test, 2 sided||||
1716529|NCT00756613|3158710|Equivalence|The equivalence margin is 20% reduction of intensive treatment group versus standard treatment group.|Cox Proportional Hazard|0.9||||0.48|2-Sided|95.0|0.67|1.2|||Regression, Cox||||
1716530|NCT00756613|3158711|Equivalence|The equivalence margin is expected 20% reduction for the intensive treatment group compared to the standard treatment group.|Cox Proportional Hazard|1.02||||0.81|2-Sided|95.0|0.88|1.18|||Regression, Cox||||
1716531|NCT00756613|3158712|Equivalence|We considered a 20% reduction in primary events to be a reasonable goal of intensive glycemic control over the anticipated 15-year study time period. This effect size was chosen by taking into consideration both the probability of observing an effect of that size given the level of achieved A1c separation, and the perceived value to the patient of this level of benefit relative to the risk and burden of intensive glycemic control.|Cox Proportional Hazard|0.91||||0.24|2-Sided|95.0|0.78|1.06|||Regression, Cox|||To determine the long term effects of intensive glycemic control in type 2 diabetes on major cardiovascular events.|
1716532|NCT00756275|3158782|Superiority or Other||Mean Difference (Final Values)|-0.56|Standard Error of the Mean|1.72||0.75|2-Sided|95.0|-3.98|2.87|||t-test, 2 sided||||
1716533|NCT00756275|3158783|Superiority or Other|||||||0.18|||||||Chi-squared||||
1716534|NCT00756275|3158784|Superiority or Other|||||||0.72|||||||Chi-squared||||
1716535|NCT00756275|3158785|Superiority or Other|||||||0.31|||||||Chi-squared||||
1716536|NCT00756275|3158786|Superiority or Other|||||||0.57|||||||Chi-squared||||
1716537|NCT00756275|3158787|Superiority or Other||Mean Difference (Final Values)|7.39|Standard Error of the Mean|8.1||0.36|2-Sided|95.0|-8.73|23.52|||t-test, 2 sided||||
1716538|NCT00756275|3158788|Superiority or Other||Mean Difference (Final Values)|-7.98|Standard Error of the Mean|8.38||0.34|2-Sided|95.0|-24.64|8.68|||t-test, 2 sided||||
1716539|NCT00756275|3158789|Superiority or Other||Odds Ratio (OR)|2.9||||0.3|2-Sided|95.0|0.58|14.5|||Fisher Exact||||
1716540|NCT00756275|3158790|Superiority or Other||Mean Difference (Final Values)|-1.59|Standard Error of the Mean|2.36||0.5|2-Sided|95.0|-6.29|3.11|||t-test, 2 sided||||
1716541|NCT00756275|3158791|Superiority or Other||Odds Ratio (OR)|4.33|||<|0.05|2-Sided|95.0|0.91|20.56|||Chi-squared||||
1717256|NCT00744380|3160318|Superiority or Other||||||>|0.1|||||||Chi-squared, Corrected|||For hypotension|
1716543|NCT00756002|3158804|Superiority or Other|||||||0.003||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716544|NCT00756002|3158805|Superiority or Other|||||||0.028||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716545|NCT00756002|3158806|Superiority or Other|||||||0.097||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716546|NCT00756002|3158807|Superiority or Other|||||||0.015||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716547|NCT00756002|3158808|Superiority or Other|||||||0.591||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716548|NCT00756002|3158809|Superiority or Other|||||||0.929||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716549|NCT00756002|3158810|Superiority or Other|||||||0.814||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716550|NCT00756002|3158811|Superiority or Other|||||||0.04||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716551|NCT00756002|3158812|Superiority or Other|||||||0.004||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716552|NCT00756002|3158813|Superiority or Other|||||||0.001||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716553|NCT00756002|3158814|Superiority or Other|||||||0.004||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716554|NCT00756002|3158815|Superiority or Other|||||||0.005||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716555|NCT00756002|3158816|Superiority or Other|||||||0.099||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716556|NCT00756002|3158817|Superiority or Other|||||||0.228||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716557|NCT00756002|3158818|Superiority or Other|||||||0.665||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716558|NCT00756002|3158819|Superiority or Other|||||||0.422||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716559|NCT00756002|3158820|Superiority or Other|||||||0.785||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716560|NCT00756002|3158821|Superiority or Other||||||<|0.001||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716561|NCT00756002|3158822|Superiority or Other||||||<|0.001||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716562|NCT00756002|3158823|Superiority or Other||||||<|0.001||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1717257|NCT00744380|3160319|Superiority or Other|||||||0.17|||||||Chi-squared|||For pain scores|
1716563|NCT00756002|3158824|Superiority or Other||||||<|0.001||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716564|NCT00756002|3158825|Superiority or Other||||||<|0.001||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716565|NCT00756002|3158826|Superiority or Other||||||<|0.001||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716566|NCT00756002|3158827|Superiority or Other||||||<|0.001||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.|||
1716567|NCT00756002|3158828|Superiority or Other||||||<|0.001||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.|||
1716568|NCT00756002|3158829|Superiority or Other||||||<|0.001||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with the Baseline value as a covariate.|||
1716569|NCT00756002|3158830|Superiority or Other|||||||0.006||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716570|NCT00756002|3158831|Superiority or Other|||||||0.002||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716571|NCT00756002|3158832|Superiority or Other|||||||0.01||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716572|NCT00756002|3158833|Superiority or Other|||||||0.005||||||P-values for differences are obtained using t-tests from the ANCOVA model of the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716573|NCT00756002|3158834|Superiority or Other|||||||0.043||||||LS means from ANCOVA model with effects for treatment & pooled center, with Baseline as a covariate. P-values from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA||||
1716574|NCT00756002|3158835|Superiority or Other||||||<|0.001||||||LS means from ANCOVA model with effects for treatment & pooled center, with Baseline as a covariate. P-values from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA||||
1716575|NCT00756002|3158836|Superiority or Other||||||<|0.001||||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716576|NCT00756002|3158837|Superiority or Other||||||<|0.001||||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716577|NCT00756002|3158838|Superiority or Other||||||<|0.001||||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716578|NCT00756002|3158839|Superiority or Other||||||<|0.001||||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716579|NCT00756002|3158840|Superiority or Other||||||<|0.001||||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716580|NCT00756002|3158841|Superiority or Other||||||<|0.001||||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716581|NCT00756002|3158842|Superiority or Other||||||<|0.001||||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716582|NCT00756002|3158843|Superiority or Other||||||<|0.001||||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716583|NCT00756002|3158844|Superiority or Other|||||||0.003||||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||One subject did not have postsleep questionnaire data on day 2; however, had polysomnography data recorded. Analysis was based on LOCF data.|
1716584|NCT00756002|3158845|Superiority or Other||||||<|0.001||||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716585|NCT00756002|3158846|Superiority or Other||||||<|0.001||||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.|||
1716586|NCT00756002|3158847|Superiority or Other||||||<|0.001||||||P-values are from t-tests of the ANCOVA model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|ANCOVA|Least Squares (LS) means from ANCOVA model with effects for treatment and pooled center, with Baseline as a covariate.||One subject did not have postsleep questionnaire data on day 2; however, had polysomnography data recorded. Analysis was based on LOCF data.|
1716587|NCT00755937|3158849|Superiority or Other||Percentage (no inferential test)|72.1|||||||||||||||
1716588|NCT00755937|3158850|Superiority or Other||Percentage (no inferential test)|64.8|||||||||||||||
1716589|NCT00755937|3158851|Superiority or Other||Percentage (no inferential test)|60.3|||||||||||||||
1716590|NCT00755937|3158852|Superiority or Other||Percentage (no inferential test)|72.1|||||||||||||||
1716591|NCT00755937|3158853|Superiority or Other||percentage (no inferential test)|72.5|||||||||||||||
1716592|NCT00755937|3158854|Superiority or Other||Percentage (no inferential test)|66.3|||||||||||||||
1716593|NCT00755846|3158858|Superiority or Other||Mean Difference (Final Values)|-12.5|Standard Error of the Mean|21.06||0.554||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716594|NCT00755846|3158858|Superiority or Other||Mean Difference (Final Values)|23.1|Standard Error of the Mean|21.06||0.274||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716595|NCT00755846|3158858|Superiority or Other||Mean Difference (Final Values)|-19.0|Standard Error of the Mean|20.62||0.358||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716596|NCT00755846|3158858|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|21.77||0.982||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716597|NCT00755846|3158858|Superiority or Other||Mean Difference (Final Values)|-11.0|Standard Error of the Mean|20.74||0.597||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716598|NCT00755846|3158858|Superiority or Other||Mean Difference (Final Values)|-4.0|Standard Error of the Mean|16.37||0.809||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716599|NCT00755846|3158859|Superiority or Other||Mean Difference (Final Values)|-9.4|Standard Error of the Mean|22.03||0.672||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716735|NCT00755807|3158895|Superiority or Other|||||||0.047||||||P-value is for treatment comparison of change from baseline on Bicarbonate, HCO3. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.|||
1716600|NCT00755846|3158859|Superiority or Other||Mean Difference (Final Values)|8.5|Standard Error of the Mean|21.94||0.697||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716601|NCT00755846|3158859|Superiority or Other||Mean Difference (Final Values)|-9.0|Standard Error of the Mean|21.73||0.679||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716602|NCT00755846|3158859|Superiority or Other||Mean Difference (Final Values)|11.5|Standard Error of the Mean|22.85||0.616||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716603|NCT00755846|3158859|Superiority or Other||Mean Difference (Final Values)|-12.8|Standard Error of the Mean|21.85||0.557||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716604|NCT00755846|3158859|Superiority or Other||Mean Difference (Final Values)|-2.2|Standard Error of the Mean|17.17||0.897||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline triglycerides as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in triglycerides. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716605|NCT00755846|3158860|Superiority or Other||Mean Difference (Final Values)|11.1|Standard Error of the Mean|5.16||0.033||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716606|NCT00755846|3158860|Superiority or Other||Mean Difference (Final Values)|11.0|Standard Error of the Mean|5.14||0.034||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716607|NCT00755846|3158860|Superiority or Other||Mean Difference (Final Values)|13.0|Standard Error of the Mean|4.98||0.009||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716608|NCT00755846|3158860|Superiority or Other||Mean Difference (Final Values)|8.6|Standard Error of the Mean|5.26||0.103||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716685|NCT00755807|3158882|Superiority or Other||||||<|0.001||||||P-value is for test of mean change from extension phase baseline to endpoint (Week 18). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline* Week, where participant was treated as a random effect.|||
1716736|NCT00755807|3158898|Superiority or Other|||||||1||||||This is the P-value for Physician Decision.|Fisher Exact||||
1717522|NCT00737672|3160969|Superiority or Other|||||||1|||||||Fisher Exact|Two-tailed.|||
1716609|NCT00755846|3158860|Superiority or Other||Mean Difference (Final Values)|17.6|Standard Error of the Mean|5.06|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716610|NCT00755846|3158860|Superiority or Other||Mean Difference (Final Values)|12.3|Standard Error of the Mean|4.03|<|0.003||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716611|NCT00755846|3158861|Superiority or Other||Mean Difference (Final Values)|5.2|Standard Error of the Mean|5.51||0.351||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716612|NCT00755846|3158861|Superiority or Other||Mean Difference (Final Values)|2.5|Standard Error of the Mean|5.45||0.645||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716613|NCT00755846|3158861|Superiority or Other||Mean Difference (Final Values)|7.4|Standard Error of the Mean|5.4||0.169||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716614|NCT00755846|3158861|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|5.66||0.867||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716615|NCT00755846|3158861|Superiority or Other||Mean Difference (Final Values)|9.7|Standard Error of the Mean|5.46||0.076||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716616|NCT00755846|3158861|Superiority or Other||Mean Difference (Final Values)|4.8|Standard Error of the Mean|4.31||0.269||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline LDL cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in LDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716617|NCT00755846|3158862|Superiority or Other||Mean Difference (Final Values)|1.2|Standard Error of the Mean|1.22||0.34||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716686|NCT00755807|3158882|Superiority or Other||||||<|0.001||||||P-value is for test of mean change from extension phase baseline to endpoint (Week 17). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline* Week, where participant was treated as a random effect.|||
1716737|NCT00755807|3158898|Superiority or Other|||||||1||||||This is the P-value for Lack of Efficacy.|Fisher Exact||||
1716618|NCT00755846|3158862|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|1.22||0.749||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716619|NCT00755846|3158862|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|1.19||0.628||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716620|NCT00755846|3158862|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|1.28||0.906||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716621|NCT00755846|3158862|Superiority or Other||Mean Difference (Final Values)|2.3|Standard Error of the Mean|1.2||0.052||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716622|NCT00755846|3158862|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.95||0.617||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716623|NCT00755846|3158863|Superiority or Other||Mean Difference (Final Values)|0.9|Standard Error of the Mean|1.06||0.418||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716624|NCT00755846|3158863|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|1.06||0.627||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716625|NCT00755846|3158863|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|1.05||0.348||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716626|NCT00755846|3158863|Superiority or Other||Mean Difference (Final Values)|-1.4|Standard Error of the Mean|1.11||0.22||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716687|NCT00755807|3158882|Superiority or Other||||||<|0.001||||||P-value is for test of mean change from extension phase baseline to endpoint (Week 16). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline* Week, where participant was treated as a random effect.|||
1716738|NCT00755807|3158898|Superiority or Other|||||||1||||||This is the P-value for Subject Decision.|Fisher Exact||||
1717523|NCT00737672|3160972|Superiority or Other|||||||0.035|||||||Log Rank||||
1716627|NCT00755846|3158863|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|1.05||0.742||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716628|NCT00755846|3158863|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.83||0.689||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HDL cholesterol as covariates.|Positive mean treatment difference indicates larger increase from baseline (more positive change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HDL cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716629|NCT00755846|3158864|Superiority or Other||Mean Difference (Final Values)|6.0|Standard Error of the Mean|6.32||0.34||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716630|NCT00755846|3158864|Superiority or Other||Mean Difference (Final Values)|10.3|Standard Error of the Mean|6.27||0.103||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716631|NCT00755846|3158864|Superiority or Other||Mean Difference (Final Values)|6.4|Standard Error of the Mean|6.13||0.299||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716632|NCT00755846|3158864|Superiority or Other||Mean Difference (Final Values)|7.3|Standard Error of the Mean|6.47||0.258||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716633|NCT00755846|3158864|Superiority or Other||Mean Difference (Final Values)|14.6|Standard Error of the Mean|6.14||0.018||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716634|NCT00755846|3158864|Superiority or Other||Mean Difference (Final Values)|8.9|Standard Error of the Mean|4.88||0.069||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716635|NCT00755846|3158865|Superiority or Other||Mean Difference (Final Values)|1.4|Standard Error of the Mean|6.94||0.843||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716688|NCT00755807|3158882|Superiority or Other||||||<|0.001||||||P-value is for test of mean change from extension phase baseline to endpoint (Week 15). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline* Week, where participant was treated as a random effect.|||
1716739|NCT00755807|3158898|Superiority or Other|||||||0.622||||||This is the P-value for Protocol Violation.|Fisher Exact||||
1716636|NCT00755846|3158865|Superiority or Other||Mean Difference (Final Values)|1.5|Standard Error of the Mean|6.86||0.825||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716637|NCT00755846|3158865|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|6.79||0.851||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716638|NCT00755846|3158865|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|7.13||0.901||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716639|NCT00755846|3158865|Superiority or Other||Mean Difference (Final Values)|6.4|Standard Error of the Mean|6.8||0.346||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716640|NCT00755846|3158865|Superiority or Other||Mean Difference (Final Values)|1.9|Standard Error of the Mean|5.37||0.718||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline total cholesterol as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in total cholesterol. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716641|NCT00755846|3158866|Superiority or Other||Mean Difference (Final Values)|-7.5|Standard Error of the Mean|8.47||0.378||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716642|NCT00755846|3158866|Superiority or Other||Mean Difference (Final Values)|-17.5|Standard Error of the Mean|8.48||0.04||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716643|NCT00755846|3158866|Superiority or Other||Mean Difference (Final Values)|-24.1|Standard Error of the Mean|8.26||0.004||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716644|NCT00755846|3158866|Superiority or Other||Mean Difference (Final Values)|-20.1|Standard Error of the Mean|8.73||0.022||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716689|NCT00755807|3158882|Superiority or Other||||||<|0.001||||||P-value is for test of mean change from extension phase baseline to endpoint (Week 14). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline* Week, where participant was treated as a random effect.|||
1716740|NCT00755807|3158898|Superiority or Other|||||||0.012||||||This is the P-value for Adverse Event (AE).|Fisher Exact||||
1716645|NCT00755846|3158866|Superiority or Other||Mean Difference (Final Values)|-12.5|Standard Error of the Mean|8.35||0.136||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716646|NCT00755846|3158866|Superiority or Other||Mean Difference (Final Values)|-16.3|Standard Error of the Mean|6.6||0.014||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716647|NCT00755846|3158867|Superiority or Other||Mean Difference (Final Values)|-11.7|Standard Error of the Mean|7.45||0.117||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716648|NCT00755846|3158867|Superiority or Other||Mean Difference (Final Values)|-20.7|Standard Error of the Mean|7.44||0.006||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716649|NCT00755846|3158867|Superiority or Other||Mean Difference (Final Values)|-22.1|Standard Error of the Mean|7.33||0.003||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716650|NCT00755846|3158867|Superiority or Other||Mean Difference (Final Values)|-23.8|Standard Error of the Mean|7.71||0.002||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716651|NCT00755846|3158867|Superiority or Other||Mean Difference (Final Values)|-19.2|Standard Error of the Mean|7.37||0.01||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716652|NCT00755846|3158867|Superiority or Other||Mean Difference (Final Values)|-19.5|Standard Error of the Mean|5.85|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline fasting fructosamine as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting fructosamine. The treatment effect will be evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716653|NCT00755846|3158868|Superiority or Other||Mean Difference (Final Values)|-16.3|Standard Error of the Mean|9.07||0.073||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716690|NCT00755807|3158882|Superiority or Other||||||<|0.001||||||P-value is for test of mean change from extension phase baseline to endpoint (Week 13). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline* Week, where participant was treated as a random effect.|||
1716741|NCT00755807|3158898|Superiority or Other|||||||0.244||||||This is the P-value for Discontinuation Due to Any Reason.|Fisher Exact||||
1716654|NCT00755846|3158868|Superiority or Other||Mean Difference (Final Values)|-13.6|Standard Error of the Mean|9.09||0.136||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716655|NCT00755846|3158868|Superiority or Other||Mean Difference (Final Values)|-35.5|Standard Error of the Mean|8.88|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716656|NCT00755846|3158868|Superiority or Other||Mean Difference (Final Values)|-24.6|Standard Error of the Mean|9.2|<|0.008||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716657|NCT00755846|3158868|Superiority or Other||Mean Difference (Final Values)|-29.4|Standard Error of the Mean|8.91|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716658|NCT00755846|3158868|Superiority or Other||Mean Difference (Final Values)|-23.9|Standard Error of the Mean|7.05|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between all doses of alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716659|NCT00755846|3158869|Superiority or Other||Mean Difference (Final Values)|-12.2|Standard Error of the Mean|8.56||0.156||95.0||||No multiplicity adjustments|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716660|NCT00755846|3158869|Superiority or Other||Mean Difference (Final Values)|-16.4|Standard Error of the Mean|8.57||0.057||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716661|NCT00755846|3158869|Superiority or Other||Mean Difference (Final Values)|-29.4|Standard Error of the Mean|8.38|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716662|NCT00755846|3158869|Superiority or Other||Mean Difference (Final Values)|-22.8|Standard Error of the Mean|8.68|<|0.009||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716663|NCT00755846|3158869|Superiority or Other||Mean Difference (Final Values)|-30.5|Standard Error of the Mean|8.4|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG. The treatment effect was evaluated as a contrast of each dose of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1717965|NCT00729326|3162686|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1716664|NCT00755846|3158869|Superiority or Other||Mean Difference (Final Values)|-22.2|Standard Error of the Mean|6.65|<|0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration, and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in fasting plasma glucose (FPG). The treatment effect was evaluated as a contrast of all doses of alogliptin versus placebo and was evaluated inferentially with a 2-sided t-test at the 0.05 significance level.|
1716665|NCT00755846|3158870|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.136||0.321||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.|
1716666|NCT00755846|3158870|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.137||0.008||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.|
1716667|NCT00755846|3158870|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.134||0.005||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.|
1716668|NCT00755846|3158870|Superiority or Other||Mean Difference (Final Values)|-0.34|Standard Error of the Mean|0.138||0.016||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.|
1716669|NCT00755846|3158870|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.134||0.017||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.|
1716670|NCT00755846|3158870|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.106||0.004||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.|
1716671|NCT00755846|3158871|Superiority or Other||Mean Difference (Final Values)|-0.18|Standard Error of the Mean|0.173||0.307||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.|
1716691|NCT00755807|3158882|Superiority or Other||||||<|0.001||||||P-value is for test of mean change from extension phase baseline to endpoint (Week 12). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline* Week, where participant was treated as a random effect.|||
1716692|NCT00755807|3158882|Superiority or Other||||||<|0.001||||||P-value is for test of mean change from extension phase baseline to endpoint (Week 11). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline* Week, where participant was treated as a random effect.|||
1716672|NCT00755846|3158871|Superiority or Other||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.174||0.003||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.|
1716673|NCT00755846|3158871|Superiority or Other||Mean Difference (Final Values)|-0.55|Standard Error of the Mean|0.17||0.001||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.|
1716674|NCT00755846|3158871|Superiority or Other||Mean Difference (Net)|-0.42|Standard Error of the Mean|0.176||0.017||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.|
1716675|NCT00755846|3158871|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.171||0.004||95.0||||A step-down sequential approach was used to test the hypothesis that the treatment coefficient in the model is 0 for each of the five individual active treatment groups vs. placebo.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and BMI, diabetes duration, and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance level has 90% power to detect a treatment difference (each active dose versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.|
1716676|NCT00755846|3158871|Superiority or Other||Mean Difference (Final Values)|-0.43|Standard Error of the Mean|0.135||0.001||95.0||||No multiplicity adjustments.|ANCOVA|Treatment and prior antidiabetic treatment as class effects and body mass index (BMI), diabetes duration and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c. With at least 234 patients, a two-group t-test with a 0.05 two-sided significance has at least 98% power to detect a treatment difference (all active versus placebo) in HbA1c change from baseline as small as 0.55%, assuming a common standard deviation of 0.7%.|
1716677|NCT00755807|3158872|Superiority or Other|||||||0.151||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on weight.|||
1716678|NCT00755807|3158873|Superiority or Other|||||||0.032||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on pulse rate.|||
1716679|NCT00755807|3158874|Superiority or Other|||||||0.182||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on systolic blood pressure.|||
1716680|NCT00755807|3158874|Superiority or Other|||||||0.32||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on diastolic blood pressure.|||
1716681|NCT00755807|3158875|Superiority or Other|||||||0.036||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on total protein.|||
1716682|NCT00755807|3158876|Superiority or Other|||||||0.042||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on sodium.|||
1716683|NCT00755807|3158877|Superiority or Other|||||||0.035||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon signed rank test of mean change from extension phase baseline to endpoint on monocytes.|||
1716684|NCT00755807|3158881|Superiority or Other|||||||0.706||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|1-sample t-test of mean change from extension phase baseline to endpoint on BDI-II Question #9 score for all participants who entered extension phase.|||
1716714|NCT00755807|3158886|Superiority or Other||||||<|0.001||||||The P-value is for the BPI for Mean Interference Score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI for Mean Interference score.|||
1716693|NCT00755807|3158882|Superiority or Other||||||<|0.001||||||P-value is for test of mean change from extension phase baseline to endpoint (Week 10). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline* Week, where participant was treated as a random effect.|||
1716694|NCT00755807|3158882|Superiority or Other||||||<|0.001||||||P-value is for test of mean change from extension phase baseline to endpoint (Week 9). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline* Week, where participant was treated as a random effect.|||
1716695|NCT00755807|3158882|Superiority or Other||||||<|0.001||||||P-value is for test of mean change from extension phase baseline to endpoint (Week 8). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|MMRM Model: Change from Baseline = Baseline + Investigator + Week + Baseline* Week, where participant was treated as a random effect.|||
1716696|NCT00755807|3158882|Superiority or Other||||||<|0.524||||||P-value is for test of mean change from extension phase baseline to endpoint (Week 7). P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM) Model: Change from Baseline=Baseline+Investigator+Week+Baseline*Week; participant was treated as random effect.|||
1716697|NCT00755807|3158884|Superiority or Other|||||||0.381||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Satisfaction with Sexual Function Subsection score.|||
1716698|NCT00755807|3158884|Superiority or Other|||||||0.016||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Change in Health Subsection score.|||
1716699|NCT00755807|3158884|Superiority or Other|||||||0.942||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Cognitive Function Subsection score.|||
1716700|NCT00755807|3158884|Superiority or Other|||||||0.253||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Emotional Problems score.|||
1716701|NCT00755807|3158884|Superiority or Other|||||||0.007||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Emotional Well-being Subsection score.|||
1716702|NCT00755807|3158884|Superiority or Other|||||||0.061||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Overall Quality Of Life Subsection score.|||
1716703|NCT00755807|3158884|Superiority or Other|||||||0.27||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Distress Subsection score.|||
1716704|NCT00755807|3158884|Superiority or Other|||||||0.051||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Social Function Subsection score.|||
1716705|NCT00755807|3158884|Superiority or Other|||||||0.637||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Sexual Function Subsection score.|||
1716706|NCT00755807|3158884|Superiority or Other||||||<|0.001||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Pain Subsection score.|||
1716707|NCT00755807|3158884|Superiority or Other||||||<|0.858||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Role Limitation Due to Physical Problems Subsection score.|||
1716708|NCT00755807|3158884|Superiority or Other||||||<|0.008||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Energy Subsection score.|||
1716709|NCT00755807|3158884|Superiority or Other||||||<|0.025||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Health Perceptions Subsection score.|||
1716710|NCT00755807|3158884|Superiority or Other||||||<|0.002||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Subsection score.|||
1716711|NCT00755807|3158884|Superiority or Other||||||<|0.054||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Mental Health Composite Section score.|||
1716712|NCT00755807|3158884|Superiority or Other||||||<|0.002||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on MSQOL Physical Health Composite Section score.|||
1716713|NCT00755807|3158885|Superiority or Other||||||<|0.001||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on CGI-S score for all participants who entered extension phase.|||
1717258|NCT00744380|3160319|Superiority or Other|||||||0.75|||||||Chi-squared, Corrected|||For Riker scores|
1716715|NCT00755807|3158886|Superiority or Other||||||<|0.001||||||The P-value is for the BPI-I for Enjoyment of Life. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Enjoyment Of Life score.|||
1716716|NCT00755807|3158886|Superiority or Other||||||<|0.001||||||The P-value is for the BPI-I for Sleep. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Sleep score.|||
1716717|NCT00755807|3158886|Superiority or Other||||||<|0.001||||||The P-value is for the BPI-I for Relations With Others. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from baseline to endpoint on BPI-I for Relations With Others score.|||
1716718|NCT00755807|3158886|Superiority or Other||||||<|0.001||||||The P-value is for the BPI-I for Normal Work. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Normal Work score.|||
1716719|NCT00755807|3158886|Superiority or Other||||||<|0.001||||||The P-value is for the BPI-I for Walking Ability. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Walking Ability score.|||
1716720|NCT00755807|3158886|Superiority or Other||||||<|0.001||||||The P-value is for the BPI-I for Mood. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for Mood score.|||
1716721|NCT00755807|3158886|Superiority or Other||||||<|0.001||||||The P-value is for BPI-I for General Activity. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-I for General Activity score.|||
1716722|NCT00755807|3158886|Superiority or Other||||||<|0.001||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Pain Right Now score.|||
1716723|NCT00755807|3158886|Superiority or Other||||||<|0.001||||||The P-value is for BPI-S for Average Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Average Pain score.|||
1716724|NCT00755807|3158886|Superiority or Other||||||<|0.001||||||The P-value is for BPI-S for Least Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Least Pain score.|||
1716725|NCT00755807|3158886|Superiority or Other||||||<|0.001||||||The P-value is for BPI-S for Worst Pain. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean change from extension phase baseline to endpoint on BPI-S for Worst Pain.|||
1716726|NCT00755807|3158887|Superiority or Other||||||<|0.001||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|t-test, 2 sided|One-sample t-test of mean PGI-I score at 18 weeks for all participants who entered extension phase.|||
1716727|NCT00755807|3158888|Superiority or Other||Mean Difference (Final Values)|0.77||||0.003|2-Sided|95.0|0.27|1.26||P-value is for treatment comparison of change from baseline on weight. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716728|NCT00755807|3158889|Superiority or Other||Mean Difference (Final Values)|-1.55||||0.16|2-Sided|95.0|-3.7|0.61||P-value is for treatment comparison of change from baseline on pulse rate. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716729|NCT00755807|3158890|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.787|2-Sided|95.0|-3.32|2.52||P-value is for treatment comparison of change from baseline on systolic blood pressure. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716730|NCT00755807|3158890|Superiority or Other||Mean Difference (Final Values)|-0.86||||0.322|2-Sided|95.0|-2.55|0.84||P-value is for treatment comparison of change from baseline on diastolic blood pressure. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716731|NCT00755807|3158891|Superiority or Other|||||||0.025||||||P-value is for treatment comparison of change from baseline on uric acid. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.|||
1716732|NCT00755807|3158892|Superiority or Other|||||||0.007||||||P-value is for treatment comparison of change from baseline on inorganic phosphorus. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.|||
1716733|NCT00755807|3158893|Superiority or Other|||||||0.034||||||P-value is for treatment comparison of change from baseline on platelet count. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from baseline = Treatment + Investigator.|||
1716734|NCT00755807|3158894|Superiority or Other|||||||0.033||||||P-value is for treatment comparison of change from baseline on creatinine. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Model: Rank-transformed change from Baseline = Treatment + Investigator.|||
1717259|NCT00744380|3160320|Superiority or Other|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||For fentanyl|
1716742|NCT00755807|3158899|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.662|2-Sided|95.0|-0.06|0.04||P-value is for treatment comparison of change from baseline on BDI-II Question #9 score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716743|NCT00755807|3158900|Superiority or Other|||||||0.002||||||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures model:Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment*Week+Baseline*Week; participant=random effect.|||
1716744|NCT00755807|3158901|Superiority or Other|||||||0.494||||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Acts during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact||||
1716745|NCT00755807|3158901|Superiority or Other|||||||0.494||||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Behavior during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact||||
1716746|NCT00755807|3158901|Superiority or Other|||||||0.119||||||P-value is for treatment comparison in number of participants with CSSR-S Suicidal Ideation during first 6 weeks of acute treatment. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Fisher Exact||||
1716747|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|-4.02||||0.27|2-Sided|95.0|-11.18|3.14||P-value is for treatment comparison of change from baseline on MSQOL Satisfaction with Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine||
1716748|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|-1.98||||0.504|2-Sided|95.0|-7.81|3.85||P-value is for treatment comparison of change from baseline on MSQOL Change in Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine||
1716749|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|-0.81||||0.664|2-Sided|95.0|-4.49|2.86||P-value is for treatment comparison of change from baseline on MSQOL Cognitive Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716750|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|-4.9||||0.283|2-Sided|95.0|-13.88|4.08||P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Emotional Problems score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716751|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.733|2-Sided|95.0|-4.08|2.88||P-value is for treatment comparison of change from baseline on MSQOL Emotional Well-being Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716752|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|1.77||||0.306|2-Sided|95.0|-1.63|5.17||P-value is for treatment comparison of change from baseline on MSQOL Overall Quality Of Life Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716753|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|0.38||||0.867|2-Sided|95.0|-4.1|4.87||P-value is for treatment comparison of change from baseline on MSQOL Health Distress Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716754|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|1.96||||0.374|2-Sided|95.0|-2.37|6.28||P-value is for treatment comparison of change from baseline on MSQOL Social Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716755|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.948|2-Sided|95.0|-5.77|5.39||P-value is for treatment comparison of change from baseline on MSQOL Sexual Function Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716756|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|-3.58||||0.108|2-Sided|95.0|-7.94|0.79||P-value is for treatment comparison of change from baseline on MSQOL Pain Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716757|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|-3.14||||0.441|2-Sided|95.0|-11.14|4.87||P-value is for treatment comparison of change from baseline on MSQOL Role Limitation Due to Physical Problems Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716775|NCT00755807|3158904|Superiority or Other||Mean Difference (Final Values)|0.66||||0.016|2-Sided|95.0|0.12|1.2||P-value is for BPI Severity for Worst Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716758|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.991|2-Sided|95.0|-4.07|4.02||P-value is for treatment comparison of change from baseline on MSQOL Energy Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716759|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.973|2-Sided|95.0|-3.58|3.46||P-value is for treatment comparison of change from baseline on MSQOL Health Perceptions Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716760|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|-0.69||||0.72|2-Sided|95.0|-4.51|3.12||P-value is for treatment comparison of change from baseline on MSQOL Physical Health Subsection score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716761|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|-1.22||||0.512|2-Sided|95.0|-4.87|2.44||P-value is for treatment comparison of change from baseline on MSQOL Mental Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716762|NCT00755807|3158902|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.5|2-Sided|95.0|-3.9|1.91||P-value is for treatment comparison of change from baseline on MSQOL Physical Health Composite Section score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716763|NCT00755807|3158903|Superiority or Other||Mean Difference (Final Values)|0.23||||0.041|2-Sided|95.0|0.01|0.45||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716764|NCT00755807|3158904|Superiority or Other||Mean Difference (Final Values)|0.45||||0.067|2-Sided|95.0|-0.03|0.94||P-value is for BPI Mean Interference score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716765|NCT00755807|3158904|Superiority or Other||Mean Difference (Final Values)|0.17||||0.582|2-Sided|95.0|-0.45|0.79||P-value is for BPI Interference for Enjoyment Of Life score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716766|NCT00755807|3158904|Superiority or Other||Mean Difference (Final Values)|0.41||||0.148|2-Sided|95.0|-0.15|0.97||P-value is for BPI Interference for Sleep score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716767|NCT00755807|3158904|Superiority or Other||Mean Difference (Final Values)|0.5||||0.077|2-Sided|95.0|-0.06|1.05||P-value is for BPI Interference for Relations With Others score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716768|NCT00755807|3158904|Superiority or Other||Mean Difference (Final Values)|0.33||||0.291|2-Sided|95.0|-0.28|0.93||P-value is for BPI Interference for Normal Work score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716769|NCT00755807|3158904|Superiority or Other||Mean Difference (Final Values)|0.55||||0.089|2-Sided|95.0|-0.08|1.19||P-value is for BPI Interference for Walking Ability score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716770|NCT00755807|3158904|Superiority or Other||Mean Difference (Final Values)|0.66||||0.034|2-Sided|95.0|0.05|1.27||P-value is for BPI Interference for Mood score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716771|NCT00755807|3158904|Superiority or Other||Mean Difference (Final Values)|0.52||||0.083|2-Sided|95.0|-0.07|1.11||P-value is for BPI Interference for General Activity score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716772|NCT00755807|3158904|Superiority or Other||Mean Difference (Final Values)|0.89||||0.001|2-Sided|95.0|0.36|1.43||P-value is for BPI Severity for Pain Right Now score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716773|NCT00755807|3158904|Superiority or Other||Mean Difference (Final Values)|0.52||||0.03|2-Sided|95.0|0.05|0.99||P-value is for BPI Severity for Average Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1716774|NCT00755807|3158904|Superiority or Other||Mean Difference (Final Values)|0.48||||0.043|2-Sided|95.0|0.02|0.95||P-value is for BPI Severity for Least Pain score. P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|Model: Change from Baseline = Treatment + Investigator + Baseline Value.|The mean difference is for placebo - duloxetine.||
1717260|NCT00744380|3160320|Superiority or Other|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||For all midazolam|
1716776|NCT00755807|3158905|Superiority or Other||Mean Difference (Final Values)|0.21||||0.121|2-Sided|95.0|-0.06|0.49||P-values are not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANOVA|Analysis of Variance (ANOVA) Model: PGI improvement at Endpoint = Treatment + Investigator.|The mean difference is for placebo - duloxetine.||
1716777|NCT00755807|3158906|Superiority or Other|||||||0.165||||||P-value is for 50% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact||||
1716778|NCT00755807|3158906|Superiority or Other|||||||0.024||||||P-value is for the 30% Reduction (BOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact||||
1716779|NCT00755807|3158906|Superiority or Other|||||||0.246||||||P-value is for 50% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact||||
1716780|NCT00755807|3158906|Superiority or Other|||||||0.027||||||P-value is for the 30% Reduction (LOCF). P-values were not adjusted for multiple comparisons; a priori threshold for statistical significance was 0.05.|Fisher Exact||||
1716781|NCT00755807|3158907|Superiority or Other|||||||0.001||||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed model repeated measures (MMRM):Change from Baseline=Baseline+Treatment+Investigator+Week+Treatment*Week+Baseline*Week,participant random effect.||Null hypothesis: no difference between duloxetine and placebo on pain severity reduction as measured by weekly mean of the daily 24-hour average pain scores in participants assessed at 6 weeks. Sample size is determined using 2-sided t-test with significance level of 0.05, and 5% of randomized participants without post-baseline data due to very early discontinuation. With 119 participants per arm, study has approximately 80% power to detect an effect size of 0.375 on treatment group difference.|
1716782|NCT00755755|3158908|Superiority or Other||Median Difference (Final Values)|-18.2||||0.006|2-Sided|95.0|-33.0|-5.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p values doubled (threshold was 0.05) and confidence intervals adjusted.|Wilcoxon (Mann-Whitney)|Use of the Van Elteren extension to the Wilcoxon rank-sum test with adjustment for randomization strata|Hodges-Lehmann point estimator with corresponding Moses confidence interval.||
1716783|NCT00755755|3158908|Superiority or Other||Median Difference (Final Values)|-22.6||||0.002|2-Sided|95.0|-36.1|-8.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p-values doubled (threshold was 0.05) and confidence intervals adjusted.|Wilcoxon (Mann-Whitney)|Use of the Van Elteren extension to the Wilcoxon rank-sum test with adjustment for randomization strata|Hodges-Lehmann point estimator with corresponding Moses confidence interval.||
1716784|NCT00755755|3158909|Superiority or Other||Difference in proportions|73.7|||<|0.001|2-Sided|95.0|56.2|84.0||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p values doubled (threshold was 0.05) and confidence intervals adjusted|Cochran-Mantel-Haenszel|Adjustment for randomization strata|Confidence intervals with the use of Newcombe-Wilson score method (uncorrected)||
1716785|NCT00755755|3158909|Superiority or Other||Difference in proportions|72.7|||<|0.001|2-Sided|95.0|55.1|83.2||As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p-values doubled (threshold was 0.05) and confidence intervals adjusted|Cochran-Mantel-Haenszel|Adjustment for randomization strata|Confidence intervals with the use of Newcombe-Wilson score method (uncorrected)||
1716786|NCT00755417|3158912|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.0468|2-Sided|97.5|-0.42|0.03||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 12.|
1716787|NCT00755417|3158912|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.0433|2-Sided|97.5|-0.43|0.02||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 12.|
1716788|NCT00755417|3158913|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.08|<|0.0001|2-Sided|97.5|-0.51|-0.14||Based on the F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 4.|
1716789|NCT00755417|3158913|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.08|<|0.0016|2-Sided|97.5|-0.44|-0.08||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dosing Week 4.|
1716790|NCT00755417|3158914|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.41||0.1975|2-Sided|97.5|-1.46|0.4||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 12.|
1716791|NCT00755417|3158914|Superiority or Other||Mean Difference (Final Values)|-0.56|Standard Error of the Mean|0.42||0.183|2-Sided|97.5|-1.49|0.38||Based on F test of type III analysis.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 12|
1716792|NCT00755417|3158915|Superiority or Other||Mean Difference (Final Values)|-1.51|Standard Error of the Mean|0.38|<|0.0001|2-Sided|97.5|-2.35|-0.66||Based on F test of type III analysis|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 4.|
1716793|NCT00755417|3158915|Superiority or Other||Mean Difference (Final Values)|-0.96|Standard Error of the Mean|0.38|<|0.0117|2-Sided|97.5|-1.81|-0.11||Based on F test of type III analysis for pairwise comparison at 0.025 level.|ANCOVA|Included treatment and center factors and baseline value as a covariate, tested at the pairwise 0.025 level.||Null hypothesis was that there were no treatment differences relative to placebo in mean change from baseline in average daily number of moderate or severe hot flashes at stable dosing Week 4|
1716794|NCT00755326|3158918|Superiority|||||||0.05|||||||t-test, 2 sided||||
1716795|NCT00755222|3158930|Superiority or Other|||||||0.095|||||||ANOVA||||
1716796|NCT00755222|3158931|Superiority or Other|||||||0.442|||||||ANOVA||||
1716797|NCT00755222|3158932|Superiority or Other|||||||0.164|||||||ANOVA||||
1716798|NCT00755222|3158933|Superiority or Other|||||||0.046|||||||ANOVA||||
1716799|NCT00755222|3158934|Superiority or Other|||||||0.001|||||||ANOVA||||
1716800|NCT00755196|3158936|Superiority or Other|||||||0.23|||||||2-sided sign test||||
1716801|NCT00755131|3158937|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1716802|NCT00755131|3158938|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1716803|NCT00755131|3158939|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Sample size determination was based on a t-test assuming a normal distribution with non-equal variance with the mean and standard deviation for the experimental group (postinfarction patients) of HMGB1 levels equal to 15 ± 7 and 2 ± 1 ng/dl for the control group derived from a previous study, respectively. The required sample size was calculated to be 30 subjects per group to detect on the size of one SD with α value of 0.05 (two-sided) and power (1 – β) of 0.8.|
1716804|NCT00755105|3158940|Superiority or Other||||||<|0.05|||||||ANOVA||||
1716805|NCT00755040|3158944|Superiority||Odds Ratio (OR)|1.11|||>|0.99|2-Sided|95.0|||||Fisher Exact||||
1716806|NCT00754845|3158951|Superiority||||||<|0.01|||||||Mixed Models Analysis||||
1716807|NCT00754845|3158952|Superiority||Hazard Ratio (HR)|0.97||||0.83|2-Sided|95.0|0.73|1.28|||Log Rank||||
1716808|NCT00754845|3158953|Superiority|||||||0.007|||||||Log Rank||||
1716809|NCT00754845|3158954|Superiority||Hazard Ratio (HR)|0.66||||0.01|2-Sided|95.0|0.48|0.91|||Log Rank|Stratified by the stratification factors at randomization|||
1716810|NCT00754741|3158960|Superiority or Other|||||||0.998|||||||Chi-squared||||
1716811|NCT00754741|3158960|Superiority or Other|||||||0.419|||||||Chi-squared||||
1716812|NCT00754741|3158961|Superiority or Other|||||||0.856|||||||ANOVA||||
1716813|NCT00754741|3158961|Superiority or Other|||||||0.952|||||||ANOVA||||
1716814|NCT00754741|3158962|Superiority or Other|||||||0.733|||||||ANOVA||||
1716815|NCT00754741|3158962|Superiority or Other|||||||0.779|||||||ANOVA||||
1716816|NCT00754741|3158963|Superiority or Other|||||||0.369|||||||ANOVA||||
1716817|NCT00754741|3158963|Superiority or Other|||||||0.469|||||||ANOVA||||
1716818|NCT00754741|3158964|Superiority or Other|||||||0.443|||||||ANOVA||||
1716819|NCT00754741|3158964|Superiority or Other|||||||0.573|||||||ANOVA||||
1716820|NCT00754741|3158965|Superiority or Other|||||||0.115|||||||ANOVA||||
1716821|NCT00754741|3158965|Superiority or Other|||||||0.971|||||||ANOVA||||
1716822|NCT00754741|3158966|Superiority or Other|||||||0.283|||||||ANOVA||||
1716823|NCT00754741|3158966|Superiority or Other|||||||0.829|||||||ANOVA||||
1716824|NCT00754741|3158967|Superiority or Other|||||||0.399|||||||ANOVA||||
1716825|NCT00754741|3158967|Superiority or Other|||||||0.671|||||||ANOVA||||
1716826|NCT00754741|3158968|Superiority or Other|||||||0.968|||||||ANOVA||||
1716827|NCT00754741|3158968|Superiority or Other|||||||0.291|||||||ANOVA||||
1716828|NCT00754741|3158969|Superiority or Other|||||||0.714|||||||Chi-squared||||
1716829|NCT00754741|3158969|Superiority or Other|||||||0.134|||||||Chi-squared||||
1716830|NCT00754741|3158970|Superiority or Other|||||||0.849|||||||ANOVA||||
1716831|NCT00754741|3158970|Superiority or Other|||||||0.881|||||||ANOVA||||
1716832|NCT00754741|3158971|Superiority or Other|||||||0.53|||||||ANOVA||||
1716833|NCT00754741|3158971|Superiority or Other|||||||0.667|||||||ANOVA||||
1716834|NCT00754741|3158972|Superiority or Other|||||||0.084|||||||ANOVA||||
1716835|NCT00754741|3158972|Superiority or Other|||||||0.38|||||||ANOVA||||
1716836|NCT00754741|3158973|Superiority or Other|||||||0.285|||||||ANOVA||||
1716837|NCT00754741|3158973|Superiority or Other|||||||0.763|||||||ANOVA||||
1716838|NCT00754624|3158980|Superiority or Other||Slope|-0.311|||||2-Sided|95.0|-0.454|-0.168||||||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed DLco data to estimate the annual rate of decline. The model included terms for baseline DLco and time (in years) of DLco measurements. Missing pulmonary functions were not imputed.|
1716839|NCT00754624|3158981|Superiority or Other||Slope|-0.058|||||2-Sided|95.0|-0.072|-0.043||||||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed FVC data to estimate the annual rate of decline. The model included terms for baseline FVC and time (in years) of FVC measurements. Missing pulmonary functions were not imputed.|
1716840|NCT00754624|3158982|Superiority or Other||Slope|-0.048|||||2-Sided|95.0|-0.059|-0.037||||||A random coefficient model with a random intercept and slope associated with each subject, was fitted (using the PROC MIXED procedure in SAS) to the observed FEV1 data to estimate the annual rate of decline. The model included terms for baseline FEV1 and time (in years) of FEV1 measurements. Missing pulmonary functions were not imputed.|
1716841|NCT00754559|3159027|Superiority or Other||||||<|0.001|||||||Exact Binomial Test|||Null hypothesis: Proportion of participants reaching LDAS (≤ 3.2) at Week 24 equals (=) expected proportion of 42%.|
1716842|NCT00754546|3159029|Superiority or Other|||||||0.038|||||||t-test, 2 sided|||Arformoterol versus normal saline with cycle exercise|
1716843|NCT00754546|3159029|Superiority or Other|||||||0.024|||||||t-test, 2 sided|||Comparing arformoterol with placebo with treadmill exercise|
1717966|NCT00729326|3162687|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1716844|NCT00754546|3159029|Superiority or Other||||||<|0.05|||||||ANOVA|||"ANOVA was used to examine the interaction between mode of exercise and treatment effect.~Twenty patients were considered adequate to provide a power of 85% with an alpha of 0.05."|
1716845|NCT00754494|3159038|Superiority or Other|||||||0.083|||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|
1716846|NCT00754494|3159038|Superiority or Other|||||||0.03|||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|
1716847|NCT00754494|3159038|Superiority or Other|||||||0.654|||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|
1716848|NCT00754494|3159039|Superiority or Other|||||||0.261|||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|
1716849|NCT00754494|3159039|Superiority or Other|||||||0.03|||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|
1716850|NCT00754494|3159039|Superiority or Other|||||||0.651|||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|
1716851|NCT00754494|3159040|Superiority or Other|||||||0.233|||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|
1716852|NCT00754494|3159040|Superiority or Other|||||||0.085|||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|
1716853|NCT00754494|3159040|Superiority or Other|||||||0.369|||||||General Linear Model|||A log-transformation of total EGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median total EGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|
1716854|NCT00754494|3159041|Superiority or Other|||||||0.855|||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|
1716855|NCT00754494|3159041|Superiority or Other|||||||0.125|||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|
1716856|NCT00754494|3159041|Superiority or Other|||||||0.762|||||||General Linear Model|||A log-transformation of pEGFR was utilized in primary analyses because of the highly skewed distribution observed in this outcome. The general linear model was used to estimate and compare the relative change in median pEGFR with adjustment for actin as a normalizing factor. The estimated relative change (post:pre) in the median, corresponding 95% confidence interval, and p-value for testing the null hypothesis of equal medians comparing pre- and post-measurements were reported.|
1716857|NCT00754442|3159046|Superiority or Other (legacy)|||||||0.003|||||||t-test, 2 sided|||The null hypothesis is that there is no statistical difference between patients and controls at 8 hrs|
1716858|NCT00754442|3159046|Superiority or Other (legacy)|||||||0.002|||||||t-test, 2 sided|||The null hypothesis is that there is no statistical difference between patients and controls at 4 hours|
1716859|NCT00754442|3159046|Superiority or Other (legacy)|||||||0.1||||||see above|t-test, 2 sided|95%||The null hypothesis is that there is no statistical difference between patients and controls at baseline|
1716860|NCT00754390|3159047|Superiority or Other|||||||0.09|||||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium and dietary phytate do not affect zinc absorption. Eight women were required to detect a difference in zinc absorption of 7 percentage points with a power of 90%, alpha level of 0.05.|
1716861|NCT00754390|3159047|Superiority or Other|||||||0.0002|||||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary Phytate does not affect zinc absorption|
1716862|NCT00754390|3159047|Superiority or Other|||||||0.17|||||||Mixed Models Analysis|||Two-way mixed model analysis of variance was used to test for main effect of dietary calcium and phytate and their interaction. Null Hypothesis: Dietary calcium does not affect zinc absorption|
1716863|NCT00754377|3159048|Superiority or Other|||||||0.001|||||||t-test, 2 sided||||
1716864|NCT00754377|3159049|Superiority or Other|||||||0.02|||||||t-test, 2 sided||||
1716865|NCT00754156|3159080|Non-Inferiority or Equivalence|Equivalence analysis|||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1716866|NCT00754065|3159207|Superiority or Other||F-statistic|9.3218||||0.0024||||||Comparison of EV/DNG vs. EE/NGM|ANOVA|||2-way ANOVA model with treatment and pain strata (headache and pelvic pain) as factors|
1716867|NCT00753935|3159216|Superiority|||||||0.005|||||||Wilcoxon rank-sum||||
1716868|NCT00753688|3159252|Superiority or Other||Hazard Ratio (HR)|0.39|||<|0.001|2-Sided|95.0|0.25|0.6||Stratified two-sided log rank p-value for other STS histologies|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).||
1716869|NCT00753688|3159252|Superiority or Other||Hazard Ratio (HR)|0.43|||<|0.005|2-Sided|95.0|0.19|0.98||Stratified two-sided log rank p-value for synovial sarcoma|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).||
1716870|NCT00753688|3159252|Superiority or Other||Hazard Ratio (HR)|0.37|||<|0.001|2-Sided|95.0|0.23|0.6||Stratified two-sided log rank p-value for leiomyosarcoma|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).||
1716871|NCT00753688|3159256|Superiority or Other||Hazard Ratio (HR)|0.86||||0.256|2-Sided|95.0|0.67|1.12||Stratified two-sided log rank p-value|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).||
1716872|NCT00753688|3159257|Superiority or Other||Hazard Ratio (HR)|0.35|||<|0.001|2-Sided|95.0|0.26|0.48||Stratified two-sided log rank p-value|Log Rank||The HR was adjusted for World Health Organization (WHO) performance status scale (0 versus 1 at Baseline) and number of prior lines of systemic treatment for advanced disease (0/1 versus 2+).||
1716873|NCT00753623|3159278|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1716874|NCT00753545|3159279|Superiority or Other (legacy)||Hazard Ratio (HR)|1.16||||0.38|2-Sided|95.0|0.83|1.64|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR < 1 favours olaparib|
1716875|NCT00753545|3159280|Superiority or Other (legacy)||Hazard Ratio (HR)|1.08||||0.67|2-Sided|95.0|0.75|1.56|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR < 1 favours olaparib|
1716876|NCT00753545|3159281|Superiority or Other (legacy)||Hazard Ratio (HR)|1.23||||0.22|2-Sided|95.0|0.88|1.71|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR < 1 favours olaparib|
1716877|NCT00753545|3159285|Superiority or Other (legacy)||Hazard Ratio (HR)|0.35|||<|1e-05|2-Sided|95.0|0.25|0.47|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR < 1 favours olaparib|
1716878|NCT00753545|3159289|Superiority or Other (legacy)||Difference in LS means|-27.1||||0.03185|2-Sided|95.0|-51.9|-2.4|||ANCOVA|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||LS mean < 0 favours olaparib|
1716879|NCT00753545|3159293|Superiority or Other (legacy)||Hazard Ratio (HR)|0.73||||0.02|2-Sided|95.0|0.55|0.95|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR < 1 favours olaparib|
1716880|NCT00753545|3159294|Superiority or Other (legacy)||Hazard Ratio (HR)|0.35|||<|1e-05|2-Sided|95.0|0.25|0.49|||Regression, Cox|The model includes factors for treatment, ethnic descent, platinum sensitivity and response to final platinum therapy.||HR < 1 favours olaparib|
1716881|NCT00753506|3159300|Superiority or Other||F|1.59|||>|0.1|2-Sided|95.0|||||ANOVA|||Repeated measures analaysis of variance|
1716882|NCT00752908|3159396|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1716883|NCT00752895|3159397|Superiority or Other|||||||0.82||||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Negative binomial regression||||
1716884|NCT00752895|3159398|Superiority or Other|||||||0.295||||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Negative binomial regression||||
1716885|NCT00752791|3159405|Superiority or Other||Mean change from Baseline|0.1|||||2-Sided|95.0|-0.24|0.44|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.||
1716886|NCT00752726|3159407|Superiority or Other||Adjusted Mean Difference|1.66|Standard Error of the Mean|1.542||0.2847|2-Sided|95.0|-1.4|4.72||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean difference was adjusted for the treatment, baseline value and center effects using an ANCOVA model.|Adjusted mean difference was calculated as placebo minus orlistat.|The null hypothesis considered no difference in the change from baseline to week 24 between the treatment groups.|
1717967|NCT00729326|3162688|Superiority or Other|||||||0.766|||||||ANCOVA||||
1716887|NCT00752726|3159408|Superiority or Other||Adjusted Mean Difference|783.8|Standard Error of the Mean|726.54||0.28|2-Sided|95.0|-657.3|2224.9||P-value was not adjusted for multiple comparisons|ANCOVA|Mean change was adjusted for the treatment, baseline total calories expended and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.|
1716888|NCT00752726|3159409|Superiority or Other||Adjusted Mean Difference|-0.023|Standard Error of the Mean|0.0232||0.3235|2-Sided|95.0|-0.069|0.023||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline liver fat and center effects, using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.|
1716889|NCT00752726|3159411|Superiority or Other||Adjusted Mean Difference|1.7|Standard Error of the Mean|0.974||0.085|2-Sided|95.0|-0.24|3.63||P-value was not adjusted for multiple comparisons|ANCOVA|Mean change was adjusted for the treatment, baseline waist circumference and center effects, using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.|
1716890|NCT00752726|3159412|Superiority or Other||Adjusted Mean Difference|1.47|Standard Error of the Mean|0.704||0.039|2-Sided|95.0|0.07|2.87||P-value was not adjusted for multiple comparisons|ANCOVA|Mean was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was evaluated.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.|
1716891|NCT00752726|3159413|Superiority or Other||Adjusted Mean Difference|1.642|Standard Error of the Mean|0.7174||0.0242|2-Sided|95.0|0.219|3.065||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline total fat mass and center effects using an ANCOVA model.|Adjusted mean difference between placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.|
1716892|NCT00752726|3159414|Superiority or Other||Adjusted Mean Difference|1.99|Standard Error of the Mean|0.881||0.026|2-Sided|95.0|0.25|3.74||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline weight and center effects, using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.|
1716893|NCT00752726|3159415|Superiority or Other||Adjusted Mean Difference|0.172|Standard Error of the Mean|0.0834||0.0415|2-Sided|95.0|0.007|0.337||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for the treatment, baseline VAT and center effects using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined.|The null hypothesis considered no difference in the change from baseline to week 12 between the two treatment groups.|
1716894|NCT00752726|3159416|Superiority or Other||Adjusted Mean Difference|0.263|Standard Error of the Mean|0.115||0.0244|2-Sided|95.0|0.035|0.491||P-value was not adjusted for multiple comparisons.|ANCOVA|Mean change was adjusted for treatment, baseline VAT and center effect using an ANCOVA model.|Adjusted mean difference between Placebo group and Orlistat group was determined. For this primary analysis, only one statistical test was performed and therefore, no multiple comparison adjustment was done.|The null hypothesis considered no difference in the change from baseline to week 24 between the two treatment groups.|
1716895|NCT00752622|3159422|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to Week 54 of the Observational Phase.|
1716896|NCT00752622|3159422|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to Week 30 of the Observational Phase.|
1716897|NCT00752622|3159422|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Comparison of Infliximab from Induction baseline to evaluation Week 10.|
1716898|NCT00752609|3159430|Superiority or Other||Mean change from baseline|0.49|||||2-Sided|95.0|0.26|0.71|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.||
1716899|NCT00752609|3159430|Superiority or Other||Mean change from baseline|-0.42|||||2-Sided|95.0|-0.65|-0.19|||||A two-sided 95% CI of the estimated mean change from Baseline in hemoglobin was derived from the t-distribution.||
1716900|NCT00752089|3159467|Superiority or Other||Adjusted mean difference|1857.355|||<|0.0001|2-Sided|95.0|1371.637|2343.072||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period and fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1716901|NCT00752089|3159467|Superiority or Other||Adjusted mean difference|2106.113|||<|0.0001|2-Sided|95.0|1620.906|2591.32||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1716902|NCT00752089|3159467|Superiority or Other||Adjusted mean difference|248.758|||<|0.3164||95.0|-245.962|743.478||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included tratment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1716903|NCT00752089|3159467|Superiority or Other||Adjusted mean difference|1784.675|||<|0.0001||95.0|1296.044|2273.306||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1716968|NCT00749944|3159690|Superiority or Other||Odds Ratio (OR)|0.8|||||2-Sided|95.0|0.4|1.7|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716904|NCT00752089|3159467|Superiority or Other||Adjusted mean difference|-72.68|||<|0.7718||95.0|-574.398|429.039||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1716905|NCT00752089|3159467|Superiority or Other||Adjusted mean difference|-321.438|||<|0.199|2-Sided|95.0|-818.118|175.242||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1716906|NCT00752089|3159468|Superiority or Other||Adjusted mean difference|18.909|||<|0.0001|2-Sided|95.0|11.036|26.783||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1716907|NCT00752089|3159468|Superiority or Other||Adjusted mean difference|21.054|||<|0.0001|2-Sided|95.0|13.189|28.919||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1716908|NCT00752089|3159468|Superiority or Other||Adjusted mean difference|2.145|||<|0.5927|2-Sided|95.0|-5.874|10.164||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1716909|NCT00752089|3159468|Superiority or Other||Adjusted mean difference|22.2|||<|0.0001|2-Sided|95.0|14.28|30.12||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1716910|NCT00752089|3159468|Superiority or Other||Adjusted mean difference|3.291|||<|0.4194|2-Sided|95.0|-4.84|11.421||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1716911|NCT00752089|3159468|Superiority or Other||Adjusted mean difference|1.146|||<|0.7756|2-Sided|95.0|-6.904|9.196||No adjustment for multiple comparisons were made as the primary comparison was pre-defined.|ANOVA|The model included treatment and period as fixed and participant as random factors.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided.|
1716912|NCT00751881|3159497|Superiority or Other||Hazard ratio reduction (%)|4.5||||0.762|2-Sided|95.0||||"Step down approach:~S1 tested only if both comparisons on the primary outcome measure were statistically significant~S2 tested only if the comparison S1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative reduction in the hazard rate with teriflunomide 7 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)||
1716913|NCT00751881|3159497|Superiority or Other||Hazard ratio reduction (%)|31.5||||0.0442|2-Sided|95.0||||"Step down approach:~S1 tested only if both comparisons on the primary outcome measure were statistically significant~S2 tested only if the comparison S1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative reduction in the hazard rate with teriflunomide 14 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|"Null hypothesis:~S1: No difference between teriflunomide 14 mg and placebo~S2: No difference between teriflunomide 7 mg and placebo~The study was also sized to have 75% power to detect a 37% hazard ratio reduction in time to disability progression with teriflunomide compared to placebo."|
1716914|NCT00751881|3159498|Superiority or Other||Relative Risk Reduction (%)|22.3||||0.0183|2-Sided|95.0||||"Step down approach used to adjust for multiplicity:~H1 tested first~H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with teriflunomide 7 mg compared to placebo||
1716915|NCT00751881|3159498|Superiority or Other||Relative risk reduction (%)|36.3||||0.0001|2-Sided|95.0||||"Step down approach used to adjust for multiplicity:~H1 tested first~H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with teriflunomide 14 mg compared to placebo|"Null hypothesis:~H1: No difference between teriflunomide 14 mg and placebo~H2: No difference between teriflunomide 7 mg and placebo~The study was sized to have 94% power to detect a 25% relative risk reduction in ARR with teriflunomide compared to placebo at a 2-sided 0.05 significance level."|
1716916|NCT00751348|3159550|Non-Inferiority|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-VZV was above -10%.|Difference in percentage|-1.06|||<|0.05|2-Sided|95.0|-3.07|1.44||The P-value for all reactogenicity comparisons was below (<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-varicella zoster virus (anti-VZV) seroconversion rates.|
1717261|NCT00744380|3160320|Superiority or Other|||||||0.25|||||||Wilcoxon (Mann-Whitney)|||For open label midazolam|
1716917|NCT00751348|3159550|Non-Inferiority|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-rubella was above -10%.|Difference in percentage|-0.34|||<|0.05|2-Sided|95.0|-1.88|2.06||The P-value for all reactogenicity comparisons was below (<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-rubella seroconversion rates.|
1716918|NCT00751348|3159550|Non-Inferiority|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-mumps was above -10%.|Difference in percentage|-5.34|||<|0.05|2-Sided|95.0|-10.4|0.38||The P-value for all reactogenicity comparisons was below (<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-mumps seroconversion rates.|
1716919|NCT00751348|3159550|Non-Inferiority|Criterion for evaluation of non-inferiority: the lower limit (LL) of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Priorix-Tetra Group minus Priorix+Varilrix Group) in seroconversion rate for anti-measles was above -10%.|Difference in percentage|-1.36|||<|0.05|2-Sided|95.0|-3.77|1.66||The P-value for all reactogenicity comparisons was below (<) 0.05.|Fisher Exact|||Non-inferiority of Priorix-Tetra® vaccine vs Priorix™ and Varilrix™ administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-measles seroconversion rates.|
1716920|NCT00751179|3159558|Superiority or Other||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.|
1716921|NCT00751179|3159560|Superiority or Other||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.|
1716922|NCT00751179|3159562|Superiority or Other||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.|
1716923|NCT00751179|3159563|Superiority or Other||||||<|0.0001||||||Significance level was set at 0.05.|ANOVA|||Treatment comparison was between the change from baseline in potassium level post-rocuronium dose versus post-succinylcholine dose, using a one way ANOVA model, with treatment as the term in the model.|
1716924|NCT00751114|3159575|Superiority or Other||adjusted mean difference|-0.59|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.77|-0.42||An analysis of covariance (ANCOVA) was performed, with the HbA1c change from baseline to last on-treatment measurement as dependent variable, treatment as fixed effect and the corresponding baseline HbA1c value as covariate|ANCOVA||Difference (Insulin glargine - Sitagliptin)|"H0: no difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~H1: difference between insulin glargine mean HbA1c change and sitagliptin mean HbA1c change~Assuming:~Estimated standard deviation of the change in HbA1c of 1.3%~Expected mean difference to be detected of 0.4%~Alpha risk of 5% (two-sided)~Power of 90%~Equal sample size in each treatment group (1:1 randomization)~A total number of 446 evaluable patients (223 in each group) was required"|
1716925|NCT00750867|3159622|Superiority or Other|||||||0.025||||||The P-Value was obtained by comparing the UMSARS-II scores at final visit and at baseline.|ANOVA||||
1716926|NCT00750867|3159622|Superiority or Other|||||||0.0128||||||The P-Value was obtained by comparing the UMSARS-I scores at final visit and at baseline.|ANOVA||||
1716927|NCT00750438|3159632|Superiority|||||||0.549|||||||Regression, Linear||||
1716928|NCT00750438|3159632|Superiority|||||||0.644|||||||t-test, 2 sided||||
1716929|NCT00750438|3159632|Superiority|||||||0.372|||||||t-test, 2 sided||||
1716930|NCT00750438|3159633|Superiority|||||||0.027|||||||Regression, Linear||||
1716931|NCT00750438|3159633|Superiority|||||||0.723|||||||t-test, 2 sided|||Baseline to 24 weeks|
1716932|NCT00750438|3159633|Superiority|||||||0.001|||||||t-test, 2 sided|||Baseline to 24 weeks|
1716933|NCT00750438|3159634|Superiority|||||||0.036|||||||Regression, Linear||||
1716934|NCT00750438|3159635|Superiority|||||||0.099|||||||Regression, Linear||||
1716935|NCT00750438|3159635|Superiority|||||||0.062|||||||t-test, 2 sided|||Baseline to 24 weeks|
1716936|NCT00750438|3159635|Superiority|||||||0.559|||||||t-test, 2 sided|||Baseline and 24 weeks|
1716937|NCT00750438|3159636|Superiority|||||||0.972|||||||Regression, Linear||||
1716938|NCT00750373|3159641|Superiority or Other||Hazard Ratio (HR)|0.1|||<|0.05|2-Sided|95.0|||||Fisher Exact|||We estimated that a sample size of 74 patients would provide 80% power to detect a significant difference with respect to the primary end point at the 2-sided significance level of 0.05, assuming that the in-hospital event rate would be 23% in the conventional treatment group and 3% in the early surgery group.|
1716939|NCT00750152|3159673|Superiority or Other||one-sided p-value from CMH test|0.001||||0.025|1-Sided|95.0|||||Cochran-Mantel-Haenszel|The CMH test after stratification by site compared the proportion of complete cure in NAFT-500 to that of placebo to evaluate its superiority.||"In order to compare complete cure rate in the NAFT-500 group with that in the placebo group, the following one-sided null and alternate hypotheses will be tested:~H0: p1 <= p0~Ha: p1 > p0 where p0 and p1 denote the proportion of subjects with complete cure in the placebo and NAFT-500 groups, respectively."|
1716940|NCT00750139|3159675|Superiority or Other|||||||0.001||||||The second primary efficacy analyses will use the Cochran-Mantel-Haenszel (CMH) test after stratification by pooled clinical site. The test will be conducted with the FAS at a one-sided level of significance of α = 0.025|Cochran-Mantel-Haenszel|||"The second primary efficacy hypotheses tests are:~H02: p2 ≤ P02 vs. H2: P2 > p02 where p02 and p2 are denote proportions of complete cure in the placebo 4wks and Naftin 1% groups, respectively"|
1716969|NCT00749944|3159690|Superiority or Other||Odds Ratio (OR)|0.8|||||2-Sided|95.0|0.4|1.8|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716941|NCT00750139|3159675|Superiority or Other|||||||0.01||||||The first primary efficacy analyses will use the Cochran-Mantel-Haenszel (CMH) test after stratification by pooled clinical site. The test will be conducted with the FAS at a one-sided level of significance of α = 0.025.|Cochran-Mantel-Haenszel|||"The first primary efficacy hypotheses tests are:~H01: p1 ≤ p01 vs. H1: p1 > p01 where p01 and p1 denote the proportions of complete cure in the placebo 2wks and NAFT-500 groups, respectively."|
1716942|NCT00750061|3159676|Superiority or Other|||||||0.137|||||||Wilcoxon (Mann-Whitney)|||VAS change (M6 - D0)|
1716943|NCT00750061|3159676|Superiority or Other|||||||0.013|||||||Wilcoxon (Mann-Whitney)|||VAS change (Wk6 - D0)|
1716944|NCT00750061|3159676|Superiority or Other|||||||0.168|||||||Wilcoxon (Mann-Whitney)|||FIM change (M6 - D0)|
1716945|NCT00750061|3159676|Superiority or Other|||||||0.257|||||||Wilcoxon (Mann-Whitney)|||FIM change (Wk6 - D0)|
1716946|NCT00750061|3159677|Superiority or Other|||||||0.582|||||||Wilcoxon (Mann-Whitney)|||change motor score (m6-d0)|
1716947|NCT00750061|3159677|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|||change motor score (wk6-d0)|
1716948|NCT00750061|3159677|Superiority or Other|||||||0.32|||||||Wilcoxon (Mann-Whitney)|||change pin-prick score (m6-d0)|
1716949|NCT00750061|3159677|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|||change pin-prick score (wk6-d0)|
1716950|NCT00750061|3159677|Superiority or Other|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||change light touch score (m6-d0)|
1716951|NCT00750061|3159677|Superiority or Other|||||||0.343|||||||Wilcoxon (Mann-Whitney)|||change light touch score (wk6-d0)|
1716952|NCT00749996|3159678|Superiority or Other||Mean Difference (Net)|-1.36||||0.719|2-Sided|95.0|-8.8|6.08|||t-test, 2 sided|||The null-hypothesis(Ho: Δ ODI DIAM = Δ ODI Control) will be tested against the alternative hypothesis (HA: Δ ODI DIAM ≠ Δ ODI Control). Δ ODI DIAM = average change in the ODI (12 months - baseline) in the DIAM treated patient group and Δ VAS Control =average change in the ODI in the Control group.|
1716953|NCT00749996|3159679|Superiority or Other||Mean Difference (Net)|-0.61||||0.228|2-Sided|95.0|-1.59|0.38|||t-test, 2 sided|||The null-hypothesis: Ho: Δ VAS DIAM = Δ VAS Control will be tested against the alternative hypothesis:HA: Δ VAS DIAM ≠ Δ VAS Control.Where Δ is the average decrease in VAS score (baseline - 6 months). A minimal sample size of 240 analyzable patients is required to demonstrate with 80% power a difference in back pain reduction that is significant at the 95% level, comparing DIAM and Control groups. 268 patients will be enroll to allow of up to 10% attrition.|
1716954|NCT00749944|3159686|Superiority or Other||Odds Ratio (OR)|2.1|||||2-Sided|95.0|0.2|23.6|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716955|NCT00749944|3159687|Superiority or Other||Odds Ratio (OR)|1.0|||||2-Sided|95.0|0.3|3.7|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716956|NCT00749944|3159687|Superiority or Other||Odds Ratio (OR)|0.5|||||2-Sided|95.0|0.0|5.7|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716957|NCT00749944|3159687|Superiority or Other||Odds Ratio (OR)|0.5|||||2-Sided|95.0|0.0|5.7|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716958|NCT00749944|3159687|Superiority or Other||Odds Ratio (OR)|1.0|||||2-Sided|95.0|0.3|3.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716959|NCT00749944|3159687|Superiority or Other||Odds Ratio (OR)|0.5|||||2-Sided|95.0|0.0|5.6|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716960|NCT00749944|3159687|Superiority or Other||Odds Ratio (OR)|0.5|||||2-Sided|95.0|0.0|5.6|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716961|NCT00749944|3159689|Superiority or Other||Odds Ratio (OR)|1.2|||||2-Sided|95.0|0.5|2.8|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716962|NCT00749944|3159689|Superiority or Other||Odds Ratio (OR)|1.2|||||2-Sided|95.0|0.6|2.7|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716963|NCT00749944|3159689|Superiority or Other||Odds Ratio (OR)|1.0|||||2-Sided|95.0|0.5|2.3|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716964|NCT00749944|3159689|Superiority or Other||Odds Ratio (OR)|1.1|||||2-Sided|95.0|0.5|2.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716965|NCT00749944|3159689|Superiority or Other||Odds Ratio (OR)|1.0|||||2-Sided|95.0|0.4|2.2|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716966|NCT00749944|3159689|Superiority or Other||Odds Ratio (OR)|0.9|||||2-Sided|95.0|0.4|1.9|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716967|NCT00749944|3159689|Superiority or Other||Odds Ratio (OR)|0.9|||||2-Sided|95.0|0.3|2.3|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1717262|NCT00744380|3160321|Superiority or Other|||||||0.8|||||||Wilcoxon (Mann-Whitney)||||
1717968|NCT00729326|3162689|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1716970|NCT00749944|3159690|Superiority or Other||Odds Ratio (OR)|0.7|||||2-Sided|95.0|0.3|1.6|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716971|NCT00749944|3159690|Superiority or Other||Odds Ratio (OR)|0.8|||||2-Sided|95.0|0.4|1.6|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716972|NCT00749944|3159690|Superiority or Other||Odds Ratio (OR)|0.9|||||2-Sided|95.0|0.4|1.8|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716973|NCT00749944|3159690|Superiority or Other||Odds Ratio (OR)|0.9|||||2-Sided|95.0|0.4|2.0|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716974|NCT00749944|3159690|Superiority or Other||Odds Ratio (OR)|1.6|||||2-Sided|95.0|0.5|4.9|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716975|NCT00749944|3159691|Superiority or Other||Odds Ratio (OR)|2.1|||||2-Sided|95.0|0.8|5.3|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716976|NCT00749944|3159691|Superiority or Other||Odds Ratio (OR)|2.3|||||2-Sided|95.0|0.8|6.8|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716977|NCT00749944|3159691|Superiority or Other||Odds Ratio (OR)|1.6|||||2-Sided|95.0|0.5|5.0|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716978|NCT00749944|3159691|Superiority or Other||Odds Ratio (OR)|1.8|||||2-Sided|95.0|0.7|4.4|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716979|NCT00749944|3159691|Superiority or Other||Odds Ratio (OR)|1.9|||||2-Sided|95.0|0.7|5.3|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716980|NCT00749944|3159691|Superiority or Other||Odds Ratio (OR)|1.3|||||2-Sided|95.0|0.5|3.9|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716981|NCT00749944|3159692|Superiority or Other||Odds Ratio (OR)|1.2|||||2-Sided|95.0|0.4|3.2|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716982|NCT00749944|3159692|Superiority or Other||Odds Ratio (OR)|2.2|||||2-Sided|95.0|0.5|9.2|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716983|NCT00749944|3159692|Superiority or Other||Odds Ratio (OR)|1.8|||||2-Sided|95.0|0.4|7.8|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716984|NCT00749944|3159692|Superiority or Other||Odds Ratio (OR)|1.4|||||2-Sided|95.0|0.5|3.9|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716985|NCT00749944|3159692|Superiority or Other||Odds Ratio (OR)|3.0|||||2-Sided|95.0|0.7|11.8|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716986|NCT00749944|3159692|Superiority or Other||Odds Ratio (OR)|2.5|||||2-Sided|95.0|0.6|10.4|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716987|NCT00749944|3159693|Superiority or Other||Odds Ratio (OR)|0.6|||||2-Sided|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716988|NCT00749944|3159693|Superiority or Other||Odds Ratio (OR)|0.7|||||2-Sided|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716989|NCT00749944|3159693|Superiority or Other||Odds Ratio (OR)|0.7|||||2-Sided|95.0|0.3|1.4|||||Cochran-Mantel-Haenszel|Period BC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716990|NCT00749944|3159693|Superiority or Other||Odds Ratio (OR)|1.0|||||2-Sided|95.0|0.4|2.2|||||Cochran-Mantel-Haenszel|Period AE: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716991|NCT00749944|3159693|Superiority or Other||Odds Ratio (OR)|0.9|||||2-Sided|95.0|0.4|2.1|||||Cochran-Mantel-Haenszel|Period AD: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716992|NCT00749944|3159693|Superiority or Other||Odds Ratio (OR)|0.8|||||2-Sided|95.0|0.4|1.7|||||Cochran-Mantel-Haenszel|Period AC: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1716993|NCT00749944|3159693|Superiority or Other||Odds Ratio (OR)|1.4|||||2-Sided|95.0|0.6|3.3|||||Cochran-Mantel-Haenszel|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo. Subjects' worst scores observed in a given period were compared with the threshold criterion for analysis.|
1717524|NCT00737672|3160973|Non-Inferiority or Equivalence|One-sided test of non-inferior proportions with delta = 0.15.|||||<|0.001|||||||Z-test|One-sided.|||
1716994|NCT00749944|3159694|Superiority or Other||Difference (change from baseline)|-0.07|||||2-Sided|95.0|-0.22|8.0|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.|
1716995|NCT00749944|3159694|Superiority or Other||Difference (change from baseline)|-0.16|||||2-Sided|95.0|-0.42|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.|
1716996|NCT00749944|3159694|Superiority or Other||Difference (change from baseline)|-0.19|||||2-Sided|95.0|-0.4|0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.|
1716997|NCT00749944|3159694|Superiority or Other||Difference (change from baseline)|-0.04|||||2-Sided|95.0|-0.2|0.13|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.|
1716998|NCT00749944|3159694|Superiority or Other||Difference (change from baseline)|-0.04|||||2-Sided|95.0|-0.29|0.22|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.|
1716999|NCT00749944|3159694|Superiority or Other||Difference (change from baseline)|-0.02|||||2-Sided|95.0|-0.19|0.14|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.|
1717000|NCT00749944|3159694|Superiority or Other||Difference (change from baseline)|0.12|||||2-Sided|95.0|-0.05|0.28|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717001|NCT00749944|3159695|Superiority or Other||Difference (change from baseline)|-0.02|||||2-Sided|95.0|-0.08|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.|
1717002|NCT00749944|3159695|Superiority or Other||Difference (change from baseline)|0.06|||||2-Sided|95.0|0.01|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.|
1717003|NCT00749944|3159695|Superiority or Other||Difference (change from baseline)|-0.01|||||2-Sided|95.0|-0.15|0.13|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.|
1717004|NCT00749944|3159695|Superiority or Other||Difference (change from baseline)|-0.01|||||2-Sided|95.0|-0.07|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.|
1717005|NCT00749944|3159695|Superiority or Other||Difference (change from baseline)|0.05|||||2-Sided|95.0|-0.04|0.14|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.|
1717006|NCT00749944|3159695|Superiority or Other||Difference (change from baseline)|-0.02|||||2-Sided|95.0|-0.12|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.|
1717007|NCT00749944|3159695|Superiority or Other||Difference (change from baseline)|-0.02|||||2-Sided|95.0|-0.12|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717008|NCT00749944|3159696|Superiority or Other||Difference (change from baseline|-0.27|||||2-Sided|95.0|-0.57|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.|
1717009|NCT00749944|3159696|Superiority or Other||Difference (change from baseline|-0.08|||||2-Sided|95.0|-0.5|0.34|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.|
1717010|NCT00749944|3159696|Superiority or Other||Difference (change from baseline|-0.45|||||2-Sided|95.0|-0.83|-0.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.|
1717011|NCT00749944|3159696|Superiority or Other||Difference (change from baseline|-0.35|||||2-Sided|95.0|-0.61|-0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.|
1717012|NCT00749944|3159696|Superiority or Other||Difference (change from baseline|-0.14|||||2-Sided|95.0|-0.47|0.2|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.|
1717013|NCT00749944|3159696|Superiority or Other||Difference (change from baseline|-0.44|||||2-Sided|95.0|-0.69|-0.19|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.|
1717014|NCT00749944|3159696|Superiority or Other||Difference (change from baseline|-0.3|||||2-Sided|95.0|-0.58|-0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717015|NCT00749944|3159697|Superiority or Other||Difference (change from baseline)|-0.05|||||2-Sided|95.0|-0.17|0.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.|
1717016|NCT00749944|3159697|Superiority or Other||Difference (change from baseline)|-0.05|||||2-Sided|95.0|-0.21|0.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.|
1717017|NCT00749944|3159697|Superiority or Other||Difference (change from baseline)|0.05|||||2-Sided|95.0|-0.17|0.27|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.|
1717018|NCT00749944|3159697|Superiority or Other||Difference (change from baseline)|-0.08|||||2-Sided|95.0|-0.2|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.|
1717019|NCT00749944|3159697|Superiority or Other||Difference (change from baseline)|-0.05|||||2-Sided|95.0|-0.15|0.04|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.|
1717020|NCT00749944|3159697|Superiority or Other||Difference (change from baseline)|-0.02|||||2-Sided|95.0|-0.15|0.12|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.|
1717021|NCT00749944|3159697|Superiority or Other||Difference (change from baseline)|-0.06|||||2-Sided|95.0|-0.2|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717022|NCT00749944|3159698|Superiority or Other||Difference (change from baseline)|-0.05|||||2-Sided|95.0|-0.11|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.|
1717023|NCT00749944|3159698|Superiority or Other||Difference (change from baseline)|-0.03|||||2-Sided|95.0|-0.14|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.|
1717024|NCT00749944|3159698|Superiority or Other||Difference (change from baseline)|-0.08|||||2-Sided|95.0|-0.22|0.06|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.|
1717025|NCT00749944|3159698|Superiority or Other||Difference (change from baseline)|-0.01|||||2-Sided|95.0|-0.08|0.05|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.|
1717026|NCT00749944|3159698|Superiority or Other||Difference (change from baseline)|0.03|||||2-Sided|95.0|-0.04|0.11|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.|
1717027|NCT00749944|3159698|Superiority or Other||Difference (change from baseline)|0.0|||||2-Sided|95.0|-0.08|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.|
1717028|NCT00749944|3159698|Superiority or Other||Difference (change from baseline)|0.05|||||2-Sided|95.0|-0.03|0.12|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717029|NCT00749944|3159699|Superiority or Other||Difference (change from baseline)|-0.1|||||2-Sided|95.0|-0.17|-0.03|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.|
1717030|NCT00749944|3159699|Superiority or Other||Difference (change from baseline)|-0.1|||||2-Sided|95.0|-0.21|0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.|
1717031|NCT00749944|3159699|Superiority or Other||Difference (change from baseline)|-0.14|||||2-Sided|95.0|-0.27|-0.01|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.|
1717032|NCT00749944|3159699|Superiority or Other||Difference (change from baseline)|-0.05|||||2-Sided|95.0|-0.11|0.02|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.|
1717033|NCT00749944|3159699|Superiority or Other||Difference (change from baseline)|0.02|||||2-Sided|95.0|-0.06|0.09|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.|
1717034|NCT00749944|3159699|Superiority or Other||Difference (change from baseline)|-0.01|||||2-Sided|95.0|-0.11|0.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.|
1717035|NCT00749944|3159699|Superiority or Other||Difference (change from baseline)|0.08|||||2-Sided|95.0|-0.04|0.19|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717036|NCT00749944|3159700|Superiority or Other||Difference (change from baseline)|-0.43|||||2-Sided|95.0|-1.78|0.92|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.|
1717037|NCT00749944|3159700|Superiority or Other||Difference (change from baseline)|-0.74|||||2-Sided|95.0|-2.81|1.33|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.|
1717038|NCT00749944|3159700|Superiority or Other||Difference (change from baseline)|-0.94|||||2-Sided|95.0|-2.23|0.36|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.|
1717039|NCT00749944|3159700|Superiority or Other||Difference (change from baseline)|0.29|||||2-Sided|95.0|-1.57|2.15|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.|
1717040|NCT00749944|3159700|Superiority or Other||Difference (change from baseline)|0.06|||||2-Sided|95.0|-2.47|2.6|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.|
1717041|NCT00749944|3159700|Superiority or Other||Difference (change from baseline)|0.08|||||2-Sided|95.0|-1.54|1.71|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.|
1717042|NCT00749944|3159700|Superiority or Other||Difference (change from baseline)|0.41|||||2-Sided|95.0|-1.09|1.9|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717043|NCT00749944|3159703|Superiority or Other||Difference (change from baseline)|0.13|||||2-Sided|95.0|-0.14|0.4|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.|
1717044|NCT00749944|3159703|Superiority or Other||Difference (change from baseline)|0.17|||||2-Sided|95.0|-0.44|0.78|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.|
1717045|NCT00749944|3159703|Superiority or Other||Difference (change from baseline)|0.04|||||2-Sided|95.0|-0.4|0.48|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.|
1717046|NCT00749944|3159703|Superiority or Other||Difference (change from baseline)|0.08|||||2-Sided|95.0|-0.17|0.34|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.|
1717047|NCT00749944|3159703|Superiority or Other||Difference (change from baseline)|0.1|||||2-Sided|95.0|-0.37|0.58|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.|
1717048|NCT00749944|3159703|Superiority or Other||Difference (change from baseline)|0.02|||||2-Sided|95.0|-0.25|0.29|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.|
1717049|NCT00749944|3159703|Superiority or Other||Difference (change from baseline)|0.0|||||2-Sided|95.0|-0.26|0.27|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717050|NCT00749944|3159704|Superiority or Other||Difference (change from baseline)|1.13|||||2-Sided|95.0|-0.7|2.96|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.|
1717051|NCT00749944|3159704|Superiority or Other||Difference (change from baseline)|2.1|||||2-Sided|95.0|-2.6|6.79|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.|
1717052|NCT00749944|3159704|Superiority or Other||Difference (change from baseline)|0.61|||||2-Sided|95.0|-0.85|2.07|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.|
1717053|NCT00749944|3159704|Superiority or Other||Difference (change from baseline)|0.5|||||2-Sided|95.0|-1.18|2.18|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.|
1717054|NCT00749944|3159704|Superiority or Other||Difference (change from baseline)|1.49|||||2-Sided|95.0|-1.94|4.91|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.|
1717055|NCT00749944|3159704|Superiority or Other||Difference (change from baseline)|0.11|||||2-Sided|95.0|-0.96|1.17|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.|
1717056|NCT00749944|3159704|Superiority or Other||Difference (change from baseline)|-0.35|||||2-Sided|95.0|-1.76|1.06|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717057|NCT00749944|3159705|Superiority or Other||Difference (change from baseline)|-0.08|||||2-Sided|95.0|-0.91|0.75|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.|
1717058|NCT00749944|3159705|Superiority or Other||Difference (change from baseline)|-0.03|||||2-Sided|95.0|-1.57|1.51|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.|
1717059|NCT00749944|3159705|Superiority or Other||Difference (change from baseline)|0.5|||||2-Sided|95.0|-0.94|1.95|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.|
1717060|NCT00749944|3159705|Superiority or Other||Difference (change from baseline)|0.14|||||2-Sided|95.0|-0.62|0.9|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.|
1717061|NCT00749944|3159705|Superiority or Other||Difference (change from baseline)|0.09|||||2-Sided|95.0|-1.08|1.25|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.|
1717062|NCT00749944|3159705|Superiority or Other||Difference (change from baseline)|0.53|||||2-Sided|95.0|-0.39|1.46|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.|
1717063|NCT00749944|3159705|Superiority or Other||Difference (change from baseline)|0.27|||||2-Sided|95.0|-0.55|1.08|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717064|NCT00749944|3159706|Superiority or Other||Difference (change from baseline)|-0.09|||||2-Sided|95.0|-0.86|0.68|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BE: Difference varenicline versus placebo.|
1717065|NCT00749944|3159706|Superiority or Other||Difference (change from baseline)|-0.43|||||2-Sided|95.0|-1.69|0.82|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BD: Difference varenicline versus placebo.|
1717066|NCT00749944|3159706|Superiority or Other||Difference (change from baseline)|0.58|||||2-Sided|95.0|-0.79|1.96|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period BC: Difference varenicline versus placebo.|
1717067|NCT00749944|3159706|Superiority or Other||Difference (change from baseline)|0.03|||||2-Sided|95.0|-0.68|0.73|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AE: Difference varenicline versus placebo.|
1717068|NCT00749944|3159706|Superiority or Other||Difference (change from baseline)|-0.22|||||2-Sided|95.0|-1.16|0.71|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AD: Difference varenicline versus placebo.|
1717069|NCT00749944|3159706|Superiority or Other||Difference (change from baseline)|0.44|||||2-Sided|95.0|-0.46|1.35|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|Period AC: Difference varenicline versus placebo.|
1717070|NCT00749944|3159706|Superiority or Other||Difference (change from baseline)|0.22|||||2-Sided|95.0|-0.66|1.1|||||Mixed Models Analysis included baseline, treatment (fixed effect), subject (random effect), week (fixed effect), and interaction of treatment-by-week.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717071|NCT00749944|3159707|Superiority or Other||Difference (change from baseline)|-0.12|||||2-Sided|95.0|-0.58|0.34|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.|
1717072|NCT00749944|3159707|Superiority or Other||Difference (change from baseline)|0.1|||||2-Sided|95.0|-0.44|0.63|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.|
1717073|NCT00749944|3159707|Superiority or Other||Difference (change from baseline)|0.09|||||2-Sided|95.0|-0.41|0.59|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.|
1717074|NCT00749944|3159707|Superiority or Other||Difference (change from baseline)|0.02|||||2-Sided|95.0|-0.37|0.41|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.|
1717075|NCT00749944|3159707|Superiority or Other||Difference (change from baseline)|0.21|||||2-Sided|95.0|-0.23|0.65|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.|
1717076|NCT00749944|3159707|Superiority or Other||Difference (change from baseline)|0.21|||||2-Sided|95.0|-0.17|0.58|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.|
1717077|NCT00749944|3159707|Superiority or Other||Difference (change from baseline)|0.23|||||2-Sided|95.0|-0.2|0.65|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717078|NCT00749944|3159708|Superiority or Other||Difference (change from baseline)|0.1|||||2-Sided|95.0|-0.65|0.85|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.|
1717079|NCT00749944|3159708|Superiority or Other||Difference (change from baseline)|-0.08|||||2-Sided|95.0|-0.91|0.76|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.|
1717080|NCT00749944|3159708|Superiority or Other||Difference (change from baseline)|0.59|||||2-Sided|95.0|-0.19|1.37|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.|
1717081|NCT00749944|3159708|Superiority or Other||Difference (change from baseline)|0.26|||||2-Sided|95.0|-0.46|0.99|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.|
1717082|NCT00749944|3159708|Superiority or Other||Difference (change from baseline)|0.18|||||2-Sided|95.0|-0.55|0.92|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.|
1718342|NCT00721799|3163759|Other||Hazard Ratio (HR)|0.81||||0.58|2-Sided||||||Regression, Cox||||
1717083|NCT00749944|3159708|Superiority or Other||Difference (change from baseline)|0.54|||||2-Sided|95.0|-0.17|1.25|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.|
1717084|NCT00749944|3159708|Superiority or Other||Difference (change from baseline)|0.52|||||2-Sided|95.0|-0.29|1.32|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717085|NCT00749944|3159709|Superiority or Other||Difference (change from baseline)|1.09|||||2-Sided|95.0|-1.8|3.97|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.|
1717086|NCT00749944|3159709|Superiority or Other||Difference (change from baseline)|-0.01|||||2-Sided|95.0|-3.32|3.3|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.|
1717087|NCT00749944|3159709|Superiority or Other||Difference (change from baseline)|1.95|||||2-Sided|95.0|-0.36|4.26|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.|
1717088|NCT00749944|3159709|Superiority or Other||Difference (change from baseline)|-0.98|||||2-Sided|95.0|-3.67|1.7|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.|
1717089|NCT00749944|3159709|Superiority or Other||Difference (change from baseline)|-2.15|||||2-Sided|95.0|-5.19|0.89|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.|
1717090|NCT00749944|3159709|Superiority or Other||Difference (change from baseline)|-0.19|||||2-Sided|95.0|-2.47|2.08|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.|
1717091|NCT00749944|3159709|Superiority or Other||Difference (change from baseline)|-0.82|||||2-Sided|95.0|-3.07|1.43|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717092|NCT00749944|3159710|Superiority or Other||Difference (change from baseline)|0.38|||||2-Sided|95.0|-0.12|0.88|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BE: Difference varenicline versus placebo.|
1717093|NCT00749944|3159710|Superiority or Other||Difference (change from baseline)|0.88|||||2-Sided|95.0|0.05|1.7|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period BD: Difference varenicline versus placebo.|
1717094|NCT00749944|3159710|Superiority or Other||Difference (change from baseline)|0.52|||||2-Sided|95.0|-0.06|1.09|||||Mixed Models Analysis included baseline, t (fixed), subject (random), time (fixed), d (fixed), and interactions for t-by-time, t-by-d, time-by-d and t-by-time-by-d.|Period BC: Difference varenicline versus placebo.|
1717095|NCT00749944|3159710|Superiority or Other||Difference (change from baseline)|0.83|||||2-Sided|95.0|0.14|1.52|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AE: Difference varenicline versus placebo.|
1717096|NCT00749944|3159710|Superiority or Other||Difference (change from baseline)|1.24|||||2-Sided|95.0|0.39|2.08|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AD: Difference varenicline versus placebo.|
1717097|NCT00749944|3159710|Superiority or Other||Difference (change from baseline)|0.85|||||2-Sided|95.0|0.16|1.54|||||Mixed Models Analysis included baseline, t (fixed), subject (random), d (fixed), and interaction for t-by-d.|Period AC: Difference varenicline versus placebo.|
1717098|NCT00749944|3159710|Superiority or Other||Difference (change from baseline)|0.85|||||2-Sided|95.0|-0.02|1.72|||||Mixed Models Analysis included baseline, treatment (t; fixed), subject (random), day (d; fixed), and interaction for t-by-d.|There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717099|NCT00749944|3159711|Superiority or Other||Difference (change from baseline)|0.09|||||2-Sided|95.0|-0.47|0.65||||||Period BE: Difference varenicline versus placebo.|
1717100|NCT00749944|3159711|Superiority or Other||Difference (change from baseline)|0.39|||||2-Sided|95.0|-0.28|1.06||||||Period BD: Difference varenicline versus placebo.|
1717101|NCT00749944|3159711|Superiority or Other||Difference (change from baseline)|0.48|||||2-Sided|95.0|-0.09|1.05||||||Period BC: Difference varenicline versus placebo.|
1717102|NCT00749944|3159711|Superiority or Other||Difference (change from baseline)|0.43|||||2-Sided|95.0|-0.19|1.05||||||Period AE: Difference varenicline versus placebo.|
1717103|NCT00749944|3159711|Superiority or Other||Difference (change from baseline)|0.66|||||2-Sided|95.0|0.02|1.3||||||Period AD: Difference varenicline versus placebo.|
1717104|NCT00749944|3159711|Superiority or Other||Difference (change from baseline)|0.73|||||2-Sided|95.0|0.18|1.29||||||Period AC: Difference varenicline versus placebo.|
1717105|NCT00749944|3159711|Superiority or Other||Difference (change from baseline)|0.62|||||2-Sided|95.0|0.0|1.24||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717106|NCT00749944|3159712|Superiority or Other||Difference (change from baseline)|0.23|||||2-Sided|95.0|-0.26|0.72||||||Period BE: Difference varenicline versus placebo.|
1717107|NCT00749944|3159712|Superiority or Other||Difference (change from baseline)|0.22|||||2-Sided|95.0|-0.48|0.92||||||Period BD: Difference varenicline versus placebo.|
1717108|NCT00749944|3159712|Superiority or Other||Difference (change from baseline)|0.1|||||2-Sided|95.0|-0.58|0.78||||||Period BC: Difference varenicline versus placebo.|
1717109|NCT00749944|3159712|Superiority or Other||Difference (change from baseline)|0.44|||||2-Sided|95.0|-0.18|1.06||||||Period AE: Difference varenicline versus placebo.|
1717110|NCT00749944|3159712|Superiority or Other||Difference (change from baseline)|0.48|||||2-Sided|95.0|-0.26|1.22||||||Period AD: Difference varenicline versus placebo.|
1717111|NCT00749944|3159712|Superiority or Other||Difference (change from baseline)|0.41|||||2-Sided|95.0|-0.24|1.07||||||Period AC: Difference varenicline versus placebo.|
1717112|NCT00749944|3159712|Superiority or Other||Difference (change from baseline)|0.62|||||2-Sided|95.0|-0.15|1.39||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717113|NCT00749944|3159713|Superiority or Other||Difference (change from baseline)|-0.37|||||2-Sided|95.0|-1.37|0.63|||||Mixed Models Analysis|Period BE: Difference varenicline versus placebo.|
1717114|NCT00749944|3159713|Superiority or Other||Difference (change from baseline)|0.03|||||2-Sided|95.0|-1.18|1.24||||||Period BD: Difference varenicline versus placebo.|
1717115|NCT00749944|3159713|Superiority or Other||Difference (change from baseline)|-0.43|||||2-Sided|95.0|-1.35|0.5|||||Mixed Models Analysis|Period BC: Difference varenicline versus placebo.|
1717116|NCT00749944|3159713|Superiority or Other||Difference (change from baseline)|0.5|||||2-Sided|95.0|-0.52|1.53||||||Period AE: Difference varenicline versus placebo.|
1717117|NCT00749944|3159713|Superiority or Other||Difference (change from baseline)|0.92|||||2-Sided|95.0|-0.27|2.11||||||Period AD: Difference varenicline versus placebo.|
1717118|NCT00749944|3159713|Superiority or Other||Difference (change from baseline)|0.46|||||2-Sided|95.0|-0.5|1.43||||||Period AC: Difference varenicline versus placebo.|
1717119|NCT00749944|3159713|Superiority or Other||Difference (change from baseline)|0.72|||||2-Sided|95.0|-0.33|1.77||||||There was no hypothesis testing or power calculation in this study. Period AB: Difference varenicline versus placebo.|
1717120|NCT00749931|3159714|Superiority or Other||Relative reduction|0.47||||0.002|||||||Fisher Exact||||
1717121|NCT00749931|3159715|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1717122|NCT00749775|3159722|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at last evaluation date does not differ from that at baseline.|
1717123|NCT00749775|3159722|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 12 weeks does not differ from that at baseline.|
1717124|NCT00749775|3159722|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 8 weeks does not differ from that at baseline.|
1717125|NCT00749775|3159722|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean diastolic blood pressure at 4 weeks does not differ from that at baseline.|
1717126|NCT00749775|3159723|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at last evaluation date does not differ from that at baseline.|
1717127|NCT00749775|3159723|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 12 weeks does not differ from that at baseline.|
1717128|NCT00749775|3159723|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 8 weeks does not differ from that at baseline.|
1717129|NCT00749775|3159723|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|A one-sided paired t-test was performed to test the hypothesis.||The null hypothesis is that the mean systolic blood pressure at 4 weeks does not differ from that at baseline.|
1717130|NCT00749606|3159736|Superiority or Other||||||<|0.01|||||||Mixed Models Analysis|Mixed linear models analyzed within-subject variation in repeated measures over time. Intention to treat analysis used 5 imputations for missing data.|||
1717131|NCT00749580|3159738|Superiority or Other|||||||0.935|||||||Fisher Exact||||
1717132|NCT00749515|3159740|Other|||||||0.104|||||||t-test, 2 sided||||
1717133|NCT00749515|3159741|Other|||||||0.062|||||||t-test, 2 sided||||
1717134|NCT00749515|3159742|Other|||||||0.178|||||||t-test, 2 sided||||
1717135|NCT00749515|3159743|Other|||||||0.275|||||||t-test, 2 sided||||
1717136|NCT00749515|3159744|Other||||||<|0.001|||||||t-test, 2 sided||||
1717137|NCT00749190|3159782|Superiority or Other||Mean Difference (Final Values)|-0.64|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.84|-0.43||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 50 mg minus placebo||
1717138|NCT00749190|3159782|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.91|-0.5||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 25 mg minus placebo||
1717139|NCT00749190|3159782|Superiority or Other||Mean Difference (Final Values)|-0.71|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.91|-0.51||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 10 mg minus placebo||
1717140|NCT00749190|3159782|Superiority or Other||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.1|<|0.0002|2-Sided|95.0|-0.59|-0.18||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 5 mg minus placebo||
1717141|NCT00749190|3159782|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.1|<|0.0226|2-Sided|95.0|-0.44|-0.03||P-values are regarded as descriptive, adjustment for multiple testing was not necessary.|ANCOVA|Based on ANCOVA with terms for treatment, number of previously used anti-diabetic medications, country and baseline.|Difference calculated as empagliflozin 1 mg minus placebo||
1717142|NCT00748189|3159874|Non-Inferiority or Equivalence|Comparability of dose-normalized PAAM AUC(0-6) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-6)/Dose|0.89|||||2-Sided|90.0|0.72|1.1|||||Ratio of AUC(0-6)/Dose is the ratio of dose-normalized PAAM AUC(0-6) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).||
1718343|NCT00721799|3163760|Other||C-statistic|0.58||||0.46|2-Sided||||||Regression, Cox||||
1717143|NCT00748189|3159874|Non-Inferiority or Equivalence|Comparability of dose-normalized chlorambucil AUC(0-inf) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-inf)/Dose|1.11|||||2-Sided|90.0|0.82|1.5|||||Ratio of AUC(0-inf)/Dose is the ratio of dose-normalized chlorambucil AUC(0-inf) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).||
1717144|NCT00748189|3159874|Non-Inferiority or Equivalence|Comparability of dose-normalized chlorambucil AUC(0-6) values with ofatumumab in current study and without ofatumumab in prior study|Ratio of AUC(0-6)/Dose|1.04|||||2-Sided|90.0|0.77|1.4|||||Ratio of AUC(0-6)/Dose is the ratio of dose-normalized chlorambucil AUC(0-6) values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).||
1717145|NCT00748189|3159875|Non-Inferiority or Equivalence|Comparability of dose-normalized PAAM Cmax values with ofatumumab in current study and without ofatumumab in prior study|Ratio of Cmax/Dose|0.79|||||2-Sided|90.0|0.63|0.99|||||Ratio of Cmax/Dose is the ratio of dose-normalized PAAM Cmax values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).||
1717146|NCT00748189|3159875|Non-Inferiority or Equivalence|Comparability of dose-normalized chlorambucil Cmax values with ofatumumab in current study and without ofatumumab in prior study|Ratio of Cmax/Dose|0.71|||||2-Sided|90.0|0.53|0.94|||||Ratio of Cmax/Dose is the ratio of dose-normalized chlorambucil Cmax values when given with ofatumumab in the current study and without ofatumumab in the prior study (LEUA1001).||
1717147|NCT00748189|3159888|Other||Hazard Ratio (HR)|0.88||||0.363|2-Sided|95.0|0.65|1.17|||Log Rank||hazard ratios are obtained using the Pike estimator. A hazard ratio <1 indicates a lower risk with O+CHL treatment compared with chlorambucil||
1717148|NCT00748189|3159891|Superiority or Other||Hazard Ratio (HR)|0.57|||<|0.001|2-Sided|95.0|0.45|0.72|||Log Rank||Hazard ratios are obtained using the Pike estimator.||
1717149|NCT00748098|3159918|Superiority or Other||Adjusted mean difference versus placebo|-3.07||||0.002|2-Sided|95.0|-5.04|-1.1|||ANCOVA|Estimates were obtained using an ANCOVA model with period, group center, and treatment as fixed effects and participant as a random effect.|||
1717150|NCT00748098|3159919|Superiority or Other||Adjusted mean difference versus placebo|-26.0|||<|0.0001|2-Sided|95.0|-35.64|-16.36|||ANCOVA|Estimates were obtained using an ANCOVA model with period, group center, and treatment as fixed effects and participant as a random effect.|||
1717151|NCT00748072|3159922|Superiority or Other||Risk Ratio (RR)|0.45||||0.01|2-Sided|95.0|0.24|0.85|||Chi-squared|||The sample size was calculated by the difference in post-biopsy bleeding complications. Since the presence of bleeding was demonstrated in about 30-40 % in our previous observational study, we hypothesized a reduction risk of 0.50 and an absolute reduction of risk from 0.40 to 0.20. The sample size of the study for a power of 0.80 and a significance level <0.05 was calculated in 158 patients.|
1717152|NCT00747747|3159927|Superiority or Other||Frequency|0.0|||<|0.05|||||||Chi-squared|||Null hypotheis: no difference among the groups.|
1717153|NCT00747747|3159932|Superiority or Other||Frequency|0.0|||<|0.05|||||||Chi-squared|||Null hypothesis: no difference among groups.|
1717154|NCT00747617|3159938|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis||||
1717155|NCT00747565|3159939|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||ETDRS line scores used for statistical comparisons with mean Snellen values reported above.|
1717156|NCT00747344|3159973|Superiority or Other||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 65kg vs > 65 kg) as factors in the model.||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.|
1717157|NCT00747344|3159974|Superiority or Other||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel|Stratified by baseline weight (≤ 65 kg vs > 65 kg).||Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.|
1717158|NCT00747344|3159975|Superiority or Other||||||<|0.001||||||The study was designed to maintain a Type I error of 0.05 or less for the primary analysis.|Cochran-Mantel-Haenszel|Stratified by baseline weight (≤ 65 kg vs > 65 kg).||Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. With 120 subjects (60 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight (<=65kg vs > 65 kg). For all the scenarios evaluated, the power was > 99% at a significance level of 0.05.|
1717159|NCT00746954|3160001|Superiority or Other|||||||0.45|||||||ANOVA|||Comparisons among groups|
1717160|NCT00746941|3160010|Superiority or Other|||||||0.9086|||||||Student’s t-test||||
1717161|NCT00746941|3160011|Superiority or Other|||||||0.7132|||||||Student’s t-test||||
1717162|NCT00746863|3160014|Superiority or Other|||||||0.435||||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher’s exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|
1717163|NCT00746863|3160015|Superiority or Other|||||||0.258||||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher’s exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|
1717164|NCT00746863|3160016|Superiority or Other|||||||0.4756|||||||Chi-squared|||Chi square was performed to compared the two groups and the patient's ability to pass their voiding trial prior to discharge|
1717263|NCT00744263|3160324|Superiority or Other|||||||0.455|||||||Fisher Exact|||Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.|
1717165|NCT00746863|3160017|Superiority or Other|||||||0.0923||||||Adjusted for multiple comparisions|Wilcoxon (Mann-Whitney)|||A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.|
1717166|NCT00746863|3160018|Superiority or Other|||||||0.0251||||||A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A 2.0 cm difference on a 10.0 cm VAS scale was clinically significant. Assuming a power of 80% to detect a 2.0 difference on scores between groups, standard deviation of 2.2, an α of 0.05, then, 21 patients would be needed in each group for a total of 42 subjects. A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.|
1717167|NCT00746564|3160053|Superiority or Other||percentage of inappropriate recordings|63.2|||||2-Sided|95.0|48.1|76.2|||||||
1717168|NCT00746564|3160054|Superiority or Other||percentage of inappropriate recordings|86.2|||||2-Sided|95.0|79.4|91.0|||||||
1717169|NCT00746564|3160055|Superiority or Other||percentage of interpretable recording|92.3|||||2-Sided|95.0|91.9|92.6||||||"The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject was calculated as follows:~Duration of interpretable recording / Total duration of recording time"|
1717170|NCT00746564|3160056|Superiority or Other||percentage of interpretable recording|99.2|||||2-Sided|95.0|98.5|100.0||||||"The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject as follows:~Duration (sec) of interpretable recording / Total duration of recording time (sec)"|
1717171|NCT00746564|3160057|Superiority or Other||Percentage of recordings|85.0|||||2-Sided|95.0|78.3|91.7||||||"The positive predictive value (PPV) was calculated for each recording and for each subject during Hand to Hand and Hand to Shoulder Maneuvers as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"|
1717172|NCT00746564|3160058|Superiority or Other||percentage of recording|77.1|||||2-Sided|95.0|65.9|88.4||||||"The positive predictive value (PPV) was calculated for each recording and for each subject for the in-clinic recording during the treadmill exercise as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"|
1717173|NCT00746564|3160059|Superiority or Other||percentage of recordings|98.9|||||2-Sided|95.0|96.7|100.0||||||"The positive predictive value (PPV) was calculated for each recording and for each subject during the in-clinic recording at rest as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recording / Total amount of time (sec) R waves were recorded by device during in-clinic recording"|
1717174|NCT00746564|3160060|Superiority or Other||percentage of recordings|98.0|||||2-Sided|95.0|95.5|100.0||||||"The sensitivity was calculated for each recording and for each subject during the hand to hand and hand to shoulder maneuvers as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"|
1717175|NCT00746564|3160061|Superiority or Other||percentage of clinical recordings|98.1|||||2-Sided|95.0|95.7|100.0||||||"The sensitivity was calculated for each recording during the treadmill test and for each subject as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"|
1717176|NCT00746564|3160062|Superiority or Other||percentage of recordings|100.0|||||2-Sided|95.0|100.0|100.0||||||"The sensitivity was calculated for each recording and for each subject as follows:~Amount of time (sec) R waves recorded on surface ECG were detected on in-clinic recordings/Total amount of time (sec) R waves were recorded on surface ECG"|
1717177|NCT00746356|3160071|Non-Inferiority or Equivalence|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|0.0028|Standard Deviation|0.2852||0.0001|1-Sided|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was <0.25 volts.|
1717178|NCT00746356|3160072|Non-Inferiority or Equivalence|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|-0.0556|Standard Deviation|0.0824||0.0001|1-Sided|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met, a value of 2.5% were used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was <0.25 volts.|
1717179|NCT00746356|3160073|Non-Inferiority or Equivalence|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|-0.0625|Standard Deviation|0.0948||0.0001|1-Sided|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was <0.25 volts.|
1717216|NCT00744978|3160194|Superiority or Other||Mean Difference (Final Values)|0.02||||0.2799|2-Sided|95.0|-0.02|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717525|NCT00737672|3160974|Superiority or Other|||||||0.008||||||P-value was calculated using Kaplan-Meier methodology with 24-month follow-up data.|Log Rank||||
1717180|NCT00746356|3160074|Non-Inferiority or Equivalence|Sample size was calculated for an 80% power to reject the null hypothesis at 1.67% significance level.|Mean Difference (Final Values)|0.0066|Standard Deviation|0.3103|<|0.0001|1-Sided|95.0|-0.25|||P-value was adjusted for multiple efficacy endpoints. If all three primary effectiveness endpoints were met a value of 5% was used, if two were met a value of 2.5% was used, and if one was met a value of 1.67% was used.|t-test, 1 sided|If the data is not normally distributed, then the Wilcoxon signed rank test will be used to perform the two one-sided testing.||The null hypothesis was rejected at significance level 1.67% if the mean difference between the automatic test and the manual test was <0.25 volts.|
1717181|NCT00746252|3160082|Other|||||||0.495||||||Threshold of significance is p<.05|t-test, 2 sided|||Comparison of mean weight gain between groups.|
1717182|NCT00745901|3160097|Superiority or Other|||||||0.003|||||||Fisher Exact||||
1717183|NCT00745901|3160098|Superiority or Other|||||||0.012|||||||Fisher Exact||||
1717184|NCT00745901|3160099|Superiority or Other|||||||0.816|||||||Fisher Exact||||
1717185|NCT00745901|3160100|Superiority or Other|||||||0.002|||||||Fisher Exact||||
1717186|NCT00745901|3160101|Superiority or Other|||||||0.003|||||||Fisher Exact||||
1717187|NCT00745901|3160102|Superiority or Other|||||||0.912|||||||Fisher Exact||||
1717188|NCT00745901|3160103|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1717189|NCT00745901|3160104|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1717190|NCT00745901|3160105|Superiority or Other|||||||0.006|||||||Wilcoxon (Mann-Whitney)||||
1717191|NCT00745901|3160106|Superiority or Other|||||||0.0033|||||||Wilcoxon (Mann-Whitney)||||
1717192|NCT00745901|3160107|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1717193|NCT00745901|3160108|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1717194|NCT00745901|3160109|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1717195|NCT00745901|3160110|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1717196|NCT00745901|3160111|Superiority or Other|||||||0.0013|||||||Wilcoxon (Mann-Whitney)||||
1717197|NCT00745901|3160112|Superiority or Other|||||||0.0031|||||||Wilcoxon (Mann-Whitney)||||
1717198|NCT00745901|3160113|Superiority or Other|||||||0.0006|||||||Wilcoxon (Mann-Whitney)||||
1717199|NCT00745901|3160114|Superiority or Other|||||||0.005|||||||Wilcoxon (Mann-Whitney)||||
1717200|NCT00745901|3160115|Superiority or Other|||||||0.0715|||||||Wilcoxon (Mann-Whitney)||||
1717201|NCT00745901|3160116|Superiority or Other|||||||0.9698|||||||Wilcoxon (Mann-Whitney)||||
1717202|NCT00745849|3160119|Superiority|||||||0.45|||||||t-test, 2 sided||||
1717203|NCT00745823|3160125|Superiority or Other||Mean Difference (Net)|13.56|||||2-Sided|95.0|-7.29|34.4|||||||
1717204|NCT00745823|3160126|Superiority or Other||Mean Difference (Final Values)|0.3|||||2-Sided|95.0|-1.3|2.0|||||||
1717205|NCT00745823|3160127|Superiority or Other||Mean Difference (Final Values)|-0.2|||||2-Sided|95.0|-5.0|4.6|||||||
1717206|NCT00745823|3160128|Non-Inferiority or Equivalence|The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.|Mean Difference (Final Values)|-5.1||||0.011|2-Sided|95.0|-9.29|-1.06|||Miettinen and Nurminen||||
1717207|NCT00745823|3160129|Non-Inferiority or Equivalence|The 800 mg q.d. dosage was considered non-inferior to 400 mg b.i.d. if the lower bound of the 2-sided exact 95% CI for difference in response rate remained above -10%.|Mean Difference (Final Values)|-5.7||||0.044|2-Sided|95.0|-10.7|-0.83|||Miettinen and Nurminen||||
1717208|NCT00745498|3160144|Superiority or Other||||||<|0.05|||||||Chi-squared|||With study power of 80%, a significance level of 0.05, and the assumption that IVB injection will decrease postoperative VH incidence from 35% to 10%, a sample size of 40 patients for each group was calculated.|
1717209|NCT00745251|3160169|Superiority or Other||Mean Difference (Final Values)|-6.05|Standard Error of the Mean|1.64||0.0006|2-Sided|95.0|-9.37|-2.74|||ANCOVA||||
1717210|NCT00745251|3160170|Superiority or Other||Mean Difference (Final Values)|-14.86|Standard Error of the Mean|5.95||0.0084|1-Sided|95.0||-4.84|||ANCOVA||||
1717211|NCT00744978|3160189|Superiority or Other||Mean Difference (Final Values)|0.0||||0.8525|2-Sided|95.0|-0.02|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717212|NCT00744978|3160190|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.4974|2-Sided|95.0|-0.03|0.01||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717213|NCT00744978|3160191|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.2245|2-Sided|95.0|-0.03|0.01||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717214|NCT00744978|3160192|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.5008|2-Sided|95.0|-0.05|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717215|NCT00744978|3160193|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9675|2-Sided|95.0|-0.03|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo aAnalyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717217|NCT00744978|3160195|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.545|2-Sided|95.0|-0.07|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717218|NCT00744978|3160196|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.6632|2-Sided|95.0|-0.06|0.04||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717219|NCT00744978|3160197|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9109|2-Sided|95.0|-0.05|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717220|NCT00744978|3160198|Superiority or Other||Mean Difference (Final Values)|-1.31||||0.6251|2-Sided|95.0|-6.58|3.96||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717221|NCT00744978|3160199|Superiority or Other||Mean Difference (Final Values)|-4.15||||0.1173|2-Sided|95.0|-9.34|1.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717222|NCT00744978|3160200|Superiority or Other||Mean Difference (Final Values)|-1.53||||0.5588|2-Sided|95.0|-6.68|3.62||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Week 1: difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717223|NCT00744978|3160201|Superiority or Other||Mean Difference (Final Values)|0.0||||0.7226|2-Sided|95.0|-0.03|0.02||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717224|NCT00744978|3160202|Superiority or Other||Mean Difference (Final Values)|0.02||||0.083|2-Sided|95.0|0.0|0.05||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717225|NCT00744978|3160203|Superiority or Other||Mean Difference (Final Values)|0.0||||0.8811|2-Sided|95.0|-0.02|0.03||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717226|NCT00744978|3160204|Superiority or Other||Mean Difference (Final Values)|1.28||||0.0468|2-Sided|95.0|0.02|2.53||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717227|NCT00744978|3160205|Superiority or Other||Mean Difference (Final Values)|0.68||||0.2852|2-Sided|95.0|-0.57|1.92||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717228|NCT00744978|3160206|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9745|2-Sided|95.0|-0.26|0.27|||ANCOVA|||Difference from placebo analyzed using a mixed effects linear model with subject (nested within sequence) as a random effect, and stratum, site, period, sequence, and treatment as fixed effects.|
1717229|NCT00744978|3160207|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.4339|2-Sided|95.0|-1.3|0.56||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717230|NCT00744978|3160208|Superiority or Other||Mean Difference (Final Values)|0.59||||0.2092|2-Sided|95.0|-0.33|1.5||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717231|NCT00744978|3160209|Superiority or Other||Mean Difference (Final Values)|0.55||||0.2465|2-Sided|95.0|-0.39|1.49||ANCOVA model using unstructured covariance structure; tested using a nominal 5% Type I error rate; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717252|NCT00744380|3160317|Superiority or Other|||||||0.015|||||||Wilcoxon (Mann-Whitney)|||Median number of experiences remembered|
1717232|NCT00744978|3160210|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.3873|2-Sided|95.0|-1.37|0.53||ANCOVA model using unstructured covariance structure; Type I error rate for primary hypothesis was 5%; no adjustments made for multiplicity.|ANCOVA|||Difference from placebo. Analyzed using a mixed effects longitudinal linear model with subject (nested within sequence) as a random effect and fixed effects stratum, site, period, sequence, treatment, week, and treatment by week.|
1717233|NCT00744627|3160285|Superiority or Other||LS Mean Difference|8.78|Standard Error of the Mean|2.774||0.002|2-Sided|95.0|3.32|14.25||SF-36 social functioning subscore was the last endpoint to be tested in the hierarchical testing sequence.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||Results presented are for the number of participants at week 8 only.|
1717234|NCT00744627|3160286|Superiority or Other||LS Mean Difference|-5.1|Standard Error of the Mean|1.267|<|0.001|2-Sided|95.0|-7.61|-2.6||Pre-specified sequential statistical testing procedure indicates that when p-value <0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|||
1717235|NCT00744627|3160287|Superiority or Other||Odds Ratio (OR)|2.393|||<|0.001|2-Sided|95.0|1.496|3.83||Pre-specified sequential statistical testing procedure indicates that when p-value <0.05, hierarchical testing continues.|Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.|||
1717236|NCT00744627|3160288|Superiority or Other||LS Mean Difference|-1.96|Standard Error of the Mean|0.901||0.031|2-Sided|95.0|-3.74|-0.18||Pre-specified sequential statistical testing procedure indicates that when p-value <0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|||
1717237|NCT00744627|3160289|Superiority or Other||LS Mean Difference|-0.46|Standard Error of the Mean|0.138|<|0.001|2-Sided|95.0|-0.73|-0.19||Pre-specified sequential statistical testing procedure indicates that when p-value <0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.|||
1717238|NCT00744627|3160290|Superiority or Other||LS Mean Difference|-2.3|Standard Error of the Mean|0.555|<|0.001|2-Sided|95.0|-3.39|-1.2||Pre-specified sequential statistical testing procedure indicates that when p-value <0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis|||
1717239|NCT00744627|3160291|Superiority or Other||LS Mean Difference|-3.81|Standard Error of the Mean|0.981|<|0.001|2-Sided|95.0|-5.74|-1.88||Pre-specified sequential statistical testing procedure indicates that when p-value <0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values were from a MMRM with Baseline-by-week, center, week and week-by-treatment as factors in the analysis.||P-values were tested at the 5% level of significance (ie, statistical significance if P<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.|
1717240|NCT00744523|3160298|Superiority or Other||proportion of the primary endpoint|2.7|Standard Error of the Mean|5.0|<|0.05|1-Sided|95.0||5.2|||t-test, 1 sided||"Parameter Dispersion Type of Standard Error of the mean is meant to state that 'mean is the mean of proportions in the sense of a central-limit theorem"|The ARMOUR trial tested the null hypothesis that the MACCE rate was greater than or equal to the Performance Goal (PG) of 13% versus the alternative hypothesis that the true MACCE rate was less than the PG. The sample size was calculated based on 90% power and a Type I error rate of 0.05 (one-sided). The Performance Goal was calculated from results of carotid artery stenting trials that utilized embolic protection devices (EPD).|
1717241|NCT00744497|3160307|Superiority or Other||Odds Ratio (OR)|0.791|||||2-Sided|95.0|0.594|1.052||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for of experimental to control group.|
1717242|NCT00744497|3160308|Superiority or Other||Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.79|1.01||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.|
1717243|NCT00744497|3160309|Superiority or Other||Hazard Ratio (HR)|0.92|||||2-Sided|95.0|0.82|1.05||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.|
1717244|NCT00744497|3160310|Superiority or Other||Odds Ratio (OR)|1.28|||||2-Sided|95.0|0.93|1.763||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for experimental to control group.|
1717245|NCT00744497|3160311|Superiority or Other||Hazard Ratio (HR)|0.81|||||2-Sided|95.0|0.64|1.02||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The hazard ratio is presented for experimental to control group.|
1717246|NCT00744497|3160312|Superiority or Other||Odds Ratio (OR)|0.935|||||2-Sided|95.0|0.688|1.271||||||Since superiority of the dasatinib treatment group was not demonstrated for Overall Survival, secondary endpoints were not tested. The odds ratio is presented for experimental to control group.|
1717247|NCT00744497|3160313|Superiority or Other||Hazard Ratio (HR)|0.99||||0.9009|2-Sided|95.53|0.87|1.13||An interim analysis on survival was performed and the final test was corrected for multiplicity.|Log Rank|||Confidence intervals for median overall survival calculated using Brookmeyer and Crowley method. Compared survival in arms by 2-sided, alpha=0.0447 level, log-rank test, stratified by bisphosphonate intake (yes/no) and urinary N-telopeptide category (<60 vs ≥60 nmol/mmol creatinine) defined at randomization. Null hypothesis was survival equal in both arms. Power calculations were that ≥858 deaths would lead to ≥90% power at 5% level for rejecting null hypothesis, given true hazard ratio of 0.8.|
1717248|NCT00744380|3160314|Superiority or Other||||||>|0.1|||||||t-test, 2 sided|||For depression|
1717249|NCT00744380|3160314|Superiority or Other||||||>|0.1|||||||t-test, 2 sided|||For anxiety|
1717250|NCT00744380|3160315|Superiority or Other|||||||0.029|||||||t-test, 2 sided||||
1717251|NCT00744380|3160316|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1717264|NCT00744263|3160325|Superiority or Other|||||||0.979|||||||Fisher Exact|||Fisher exact test, 2-sided, was used to calculate the p-value for the difference between vaccine groups in percentages of participants.|
1717265|NCT00744263|3160328|Superiority or Other||Vaccine Efficacy|75.0||||0.0005|2-Sided|95.0|41.43|90.78|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.|
1717266|NCT00744263|3160329|Superiority or Other||Vaccine Efficacy|45.0||||0.0067|2-Sided|95.2|14.21|65.31|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1-(proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.|
1717267|NCT00744263|3160330|Superiority or Other||Vaccine Efficacy|45.56||||0.0006|2-Sided|95.2|21.82|62.49|||Clopper-Pearson method|||Vaccine efficacy against first event expressed as percentage. Vaccine efficacy = 1 - (proportion of participants who received 13vPnC with confirmed VT-CAP relative to those who received placebo). p-value and confidence intervals were derived using Clopper-Pearson method. The null hypothesis was vaccine efficacy = 0.|
1717268|NCT00744211|3160333|Equivalence|Chi-square tests for differences between groups.||||||0.015||||||P-value is associated with the hematological/lymphatic adverse event.|Chi-squared||||
1717269|NCT00744211|3160334|Superiority or Other||||||<|0.05|||||||ANOVA||||
1717270|NCT00744211|3160335|Superiority or Other|||||||0.001||||||Pairwise tests of individual groups means were compared by adjusted probabilities (Bonferroni method).|ANOVA||||
1717271|NCT00744211|3160336|Superiority or Other||||||<|0.05||||||p<0.05; Pairwise tests of individual groups means were compared by adjusted probabilities (Bonferroni method).|ANOVA||||
1717272|NCT00744042|3160342|Superiority or Other|||||||0.0039||||||Testing whether median change in rickets severity from Baseline to Week 24, measured by RGI-C at Week 24, is from zero.|Wilcoxon signed-rank test|The last post-baseline observation carry forward method is used; patients with no post-baseline assessments were imputed as having no change.||One treatment group|
1717273|NCT00743483|3160382|Superiority or Other|||||||0.2179|||||||t-test, 2 sided||||
1717274|NCT00743197|3160404|Non-Inferiority or Equivalence|0|Other|0.0|Standard Deviation|0.0||||||||||||0|
1717275|NCT00743106|3160407|Superiority||ratio of geometric mean|0.98||||0.78|2-Sided|95.0|0.79|1.19|||Mixed Models Analysis|||We assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on PODs 1-4). A linear mixed effects model was used to assess the main effect of fenoldopam on the postoperative log-transformed (base 2) serum creatinine, adjusting for baseline serum creatinine.|
1717276|NCT00743106|3160408|Superiority or Other||Mean Difference (Final Values)|-11.0||||0.15|2-Sided|95.0|-31.0|9.0|||Wilcoxon (Mann-Whitney)||The mean decrease in GFR was an estimated 11% less for fenoldopam than for placebo (interim-adjusted 95% confidence interval 9% more, 31% less).||
1717277|NCT00742859|3160439|Other||Hazard Ratio (HR)|0.551||||0.022|2-Sided|95.0|0.332|0.914|||Log Rank|||Betrixaban 80mg compared to Warfarin|
1717278|NCT00742859|3160439|Other||Hazard Ratio (HR)|0.767||||0.308|2-Sided|95.0|0.481|1.22|||Log Rank|||Betrixaban 60mg compared to Warfarin|
1717279|NCT00742859|3160439|Other||Hazard Ratio (HR)|0.508||||0.011|2-Sided|95.0|0.301|0.856|||Log Rank|||Betrixaban 40mg compared to Warfarin|
1717280|NCT00742859|3160440|Other||Hazard Ratio (HR)|0.755||||0.712|2-Sided|95.0|0.239|2.39|||Log Rank|||Betrixaban 80mg compared to Warfarin|
1717281|NCT00742859|3160440|Other||Hazard Ratio (HR)|0.711||||0.546|2-Sided|95.0|0.225|2.24|||Log Rank|||Betrixaban 60mg compared to Warfarin|
1717282|NCT00742859|3160440|Other||Hazard Ratio (HR)|0.14||||0.035|2-Sided|95.0|0.017|1.14|||Log Rank|||Betrixaban 40mg compared to Warfarin|
1717283|NCT00742508|3160469|Superiority or Other||Mean Difference (Net)|-0.34|Standard Error of the Mean|0.133|||2-Sided|95.0|-0.71|0.03|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.||
1717284|NCT00742508|3160469|Superiority or Other||Mean Difference (Net)|-1.42|Standard Error of the Mean|5.249|||2-Sided|95.0|-16.0|13.15|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the PDmin assessment.||
1717285|NCT00742508|3160469|Superiority or Other||Mean Difference (Net)|-10.0|Standard Error of the Mean|3.749|||2-Sided|95.0|-20.41|0.41|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the PDmax assessment.||
1717286|NCT00742508|3160469|Superiority or Other||Mean Difference (Net)|-3.11|Standard Error of the Mean|4.686|||2-Sided|95.0|-16.12|9.89|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Sleeping assessment.||
1717287|NCT00742508|3160469|Superiority or Other||Mean Difference (Net)|-2.99|Standard Error of the Mean|3.047|||2-Sided|95.0|-11.45|5.47|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Waking assessment.||
1717288|NCT00742508|3160469|Superiority or Other||Mean Difference (Net)|-4.14|Standard Error of the Mean|3.665|||2-Sided|95.0|-14.32|6.03|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Night assessment.||
1717289|NCT00742508|3160469|Superiority or Other||Mean Difference (Net)|-1.98|Standard Error of the Mean|3.209|||2-Sided|95.0|-10.89|6.94|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Afternoon assessment.||
1717290|NCT00742508|3160469|Superiority or Other||Mean Difference (Net)|-5.27|Standard Error of the Mean|2.962|||2-Sided|95.0|-13.5|2.95|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Morning assessment.||
1717291|NCT00742508|3160469|Superiority or Other||Mean Difference (Net)|-3.99|Standard Error of the Mean|3.187|||2-Sided|95.0|-12.84|4.86|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the 24 h assessment.||
1717292|NCT00742508|3160470|Superiority or Other||Mean Difference (Net)|-0.12|Standard Error of the Mean|0.152|||2-Sided|95.0|-0.54|0.3|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.||
1717293|NCT00742508|3160470|Superiority or Other||Mean Difference (Net)|1.1|Standard Error of the Mean|5.297|||2-Sided|95.0|-13.61|15.8|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the PDmin assessment.||
1717294|NCT00742508|3160470|Superiority or Other||Mean Difference (Net)|-7.46|Standard Error of the Mean|8.902|||2-Sided|95.0|-32.17|17.26|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the PDmax assessment.||
1717295|NCT00742508|3160470|Superiority or Other||Mean Difference (Net)|18.06|Standard Error of the Mean|1.694|||2-Sided|95.0|13.36|22.76|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Sleeping assessment.||
1717296|NCT00742508|3160470|Superiority or Other||Mean Difference (Net)|-3.45|Standard Error of the Mean|4.08|||2-Sided|95.0|-14.78|7.88|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Waking assessment.||
1717297|NCT00742508|3160470|Superiority or Other||Mean Difference (Net)|9.74|Standard Error of the Mean|6.07|||2-Sided|95.0|-7.11|26.59|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Night assessment.||
1717298|NCT00742508|3160470|Superiority or Other||Mean Difference (Net)|-4.93|Standard Error of the Mean|3.885|||2-Sided|95.0|-15.71|5.86|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Afternoon assessment.||
1717299|NCT00742508|3160470|Superiority or Other||Mean Difference (Net)|-0.56|Standard Error of the Mean|6.265|||2-Sided|95.0|-17.95|16.84|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Morning assessment.||
1717300|NCT00742508|3160470|Superiority or Other||Mean Difference (Net)|2.21|Standard Error of the Mean|4.833|||2-Sided|95.0|-11.2|15.63|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the 24 h assessment.||
1717301|NCT00742508|3160490|Superiority or Other||Mean Difference (Net)|-0.24|Standard Error of the Mean|0.142|||2-Sided|95.0|-0.63|0.15|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the PDmax/PDmin assessment.||
1717302|NCT00742508|3160490|Superiority or Other||Mean Difference (Net)|8.31|Standard Error of the Mean|7.194|||2-Sided|95.0|-11.67|28.28|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the PDmin assessment.||
1717303|NCT00742508|3160490|Superiority or Other||Mean Difference (Net)|-0.45|Standard Error of the Mean|10.62||||95.0|-29.94|29.03|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the PDmax assessment.||
1717304|NCT00742508|3160490|Superiority or Other||Mean Difference (Net)|25.04|Standard Error of the Mean|4.281|||2-Sided|95.0|13.16|36.93|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Sleeping assessment.||
1717305|NCT00742508|3160490|Superiority or Other||Mean Difference (Net)|0.4|Standard Error of the Mean|3.79|||2-Sided|95.0|-10.12|10.92|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Waking assessment.||
1717306|NCT00742508|3160490|Superiority or Other||Mean Difference (Net)|14.21|Standard Error of the Mean|6.361|||2-Sided|95.0|-3.45|31.87|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Night assessment.||
1717307|NCT00742508|3160490|Superiority or Other||Mean Difference (Net)|-1.92|Standard Error of the Mean|3.645|||2-Sided|95.0|-12.04|8.2|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Afternoon assessment.||
1717308|NCT00742508|3160490|Superiority or Other||Median Difference (Net)|7.55|Standard Error of the Mean|5.849|||2-Sided|95.0|-8.68|23.79|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the Morning assessment.||
1717309|NCT00742508|3160490|Superiority or Other||Mean Difference (Net)|9.38|Standard Error of the Mean|5.449|||2-Sided|95.0|-5.75|24.51|||||The mean treatment difference is calculated as SK&F-105517-D minus CRV-IR for the 24 h assessment.||
1717310|NCT00742391|3160505|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel||||
1717311|NCT00742391|3160506|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1717312|NCT00742274|3160510|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1717313|NCT00742209|3160531|Superiority or Other||Adjusted mean difference versus placebo|0.3||||0.579|2-Sided|95.0|-0.6|1.1||A combination of a sequential method and the Hochberg procedure has been used to maintain the overall experiment-size alphas level of 0.05 for the comparison of GEn vs. placebo.|ANCOVA|An ANCOVA model with baseline number of MHD and IHS Headache Classification for presence or absence of aura as covariates was used.|Adjusted mean difference versus placebo||
1717314|NCT00741936|3160548|Superiority or Other||||||<|0.05|||||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.|||
1717315|NCT00741936|3160549|Superiority or Other||||||<|0.05|||||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.|||
1717316|NCT00741936|3160550|Superiority or Other||||||<|0.05|||||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.|||
1717317|NCT00741936|3160551|Superiority or Other||||||<|0.05|||||||Paired-samples t-test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.|||
1717318|NCT00741936|3160552|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1717319|NCT00741936|3160553|Superiority or Other|||||||0|||||||simple percentage||||
1717320|NCT00741936|3160554|Superiority or Other||||||<|0.05|||||||Chi-squared|Chi-squared test from Crosstabs analysis was implemented between two treatment groups in each time frame.|||
1717321|NCT00741936|3160555|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline.|||
1717322|NCT00741936|3160556|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline|||
1717323|NCT00741936|3160557|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|T-Tests were implemented: 1) between two groups of each time frame; 2) between each treatment group of each time frame and its baseline.|||
1717324|NCT00741936|3160558|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1717325|NCT00741819|3160562|Superiority or Other|||||||0.001|||||||Wilcoxon signed-rank test||||
1717326|NCT00741819|3160564|Superiority or Other||Mean Difference (Final Values)|19.9|Standard Deviation|21.5|<|0.001||95.0|||||Wilcoxon signed rank test||Effectiveness score, change from Baseline to Week 12||
1717327|NCT00741819|3160564|Superiority or Other||Mean Difference (Final Values)|20.0|Standard Deviation|23.7|<|0.001||95.0|||||Wilcoxon signed-rank test||Global Satisfaction, change from Baseline to Week 12||
1717328|NCT00741819|3160564|Superiority or Other||Mean Difference (Final Values)|38.3|Standard Deviation|25.9|<|0.001||95.0|||||Wilcoxon signed-rank test||Convenience Score, change from Baseline to Week 12||
1717329|NCT00741819|3160564|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Deviation|21.3|<|0.895||95.0|||||Wilcoxon signed-rank test||Side-Effects Score, change from Baseline to Week 12||
1717330|NCT00741819|3160565|Superiority or Other||Mean Difference (Final Values)|-6.4|Standard Deviation|7.7|<|0.001|||||||Wilcoxon signed rank test||Analysis based on Total CAMPHOR Score.||
1717331|NCT00741819|3160566|Superiority or Other||Median Difference (Final Values)|16.0|Standard Deviation|35.9|<|0.001||95.0|||||Wilcoxon signed rank test]||Change in 6MWD from Baseline was calculated for patients still remaining on study at Week 12.|Analysis of endpoints was descriptive in nature. Numeric endpoints for post-baseline assessments were compared to Baseline using Wilcoxon signed rank test, and p-values were calculated for descriptive purposes; no formal hypothesis testing was planned.|
1717332|NCT00741390|3160579|Superiority or Other|||||||0.004|||||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.|
1717333|NCT00741390|3160579|Superiority or Other|||||||0.761|||||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.|
1717334|NCT00741390|3160579|Superiority or Other|||||||0.002|||||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.|
1717335|NCT00741390|3160579|Superiority or Other|||||||0.001|||||||Fisher Exact|One proportion two-sided test; p=50%||Analysis consisted of a one proportion test for the 1st device in the lancing pair being preferred, out of the total number of times that a preference was stated. Note: lancing pairs in which no preference was stated or where data were missing were excluded from analysis. The null hypothesis for the one proportion test was that the 1st device in the lancing pair was preferred 50% of the times.|
1717336|NCT00741390|3160580|Superiority or Other||Mean Difference (Net)|4.9||||0.017||95.0|1.14|4.9|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.|||
1717337|NCT00741390|3160581|Superiority or Other||Mean Difference (Net)|0.23||||0.46||95.0|-3.57|0.23|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.|||
1717338|NCT00741390|3160581|Superiority or Other||Mean Difference (Net)|8.55||||0.003||95.0|3.63|8.55|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.|||
1717339|NCT00741390|3160581|Superiority or Other||Mean Difference (Net)|10.84|||<|0.001||95.0|6.8|10.84|||ANOVA|A general linear model with subject as a random effect and order within a pair as a fixed effect was fit to each study group.|||
1717340|NCT00741390|3160582|Superiority or Other||Percentage|100.0||||||95.0|95.13|100.0|||||||
1717341|NCT00741390|3160582|Superiority or Other||Percentage|100.0||||||95.0|95.36|100.0|||||||
1717342|NCT00741390|3160582|Superiority or Other||Percentage|100.0||||||95.0|97.61|100.0|||||||
1717343|NCT00741390|3160582|Superiority or Other||Percentage|100.0||||||95.0|98.79|100.0|||||||
1717344|NCT00741390|3160582|Superiority or Other||Percentage|99.59||||||95.0|98.09|99.59|||||||
1717345|NCT00741286|3160585|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1717346|NCT00741286|3160586|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||To determine between-group differences of changes in the PIs at 14 and 90 days from the baseline study.|
1717347|NCT00741286|3160586|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||A linear mixed model for a repeated measures covariance pattern model with unstructured covariances within subjects was used. Two fixed effects were included: 1 between-subjects treatment effect (group: cilostazol, control) and 1 within-subject time effect (time: baseline, 14 days, 90 days). A possible difference in treatment across 14- and 90-day follow-up was analyzed by time x treatment interactions.|
1717348|NCT00741156|3160597|Superiority or Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)||||
1717349|NCT00741026|3160618|Superiority or Other|||||||0.017|||||||Wilcoxon Sign-rank||||
1717350|NCT00741026|3160619|Superiority or Other|||||||0.0184|||||||Wilcoxon Sign-rank||||
1717351|NCT00741026|3160620|Superiority or Other|||||||0.0166|||||||Wilcoxon Sign-rank||||
1717352|NCT00741026|3160621|Superiority or Other|||||||0.0105|||||||Wilcoxon Sign-rank||||
1717353|NCT00741026|3160622|Superiority or Other|||||||0.0203|||||||Wilcoxon Signed-rank||||
1717354|NCT00741013|3160624|Superiority or Other||||||<|0.05||||||Only a single statistical analysis was performed upon completion of the study.|ANOVA|||One-way analysis of variance was performed to determine whether lovastatin or rhAPC effectively reduced endotoxin-induced lung inflammation.|
1717355|NCT00740870|3160633|Superiority||Kaplan-Meier Rate|74.2|||<|0.0001|1-Sided|95.0|67.1||||Z test||||
1717356|NCT00740857|3160634|Superiority or Other||||||<|0.001|||||||proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.|||
1717357|NCT00740857|3160635|Superiority or Other||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.|||
1717358|NCT00740857|3160636|Superiority or Other||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.|||
1717359|NCT00740857|3160637|Superiority or Other||||||<|0.001|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.|
1717360|NCT00740857|3160637|Superiority or Other||||||<|0.056|||||||ANOVA|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes|
1717361|NCT00740857|3160638|Superiority or Other||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.|||
1717362|NCT00740857|3160639|Superiority or Other||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60, 90, 120, 180, 240, 300 and 360 minute individual time points all have the same P-value score.|
1717363|NCT00740857|3160639|Superiority or Other||||||<|0.041|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes|
1717364|NCT00740857|3160640|Superiority or Other||||||<|0.001|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||The 30, 45, 60....|
1717365|NCT00740857|3160640|Superiority or Other||||||<|0.118|||||||ANOVA|With treatment, baseline Pain Severity Rating (PSR), and gender terms.||15 minutes|
1717366|NCT00740857|3160641|Superiority or Other||||||<|0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.|||
1717367|NCT00740857|3160641|Superiority or Other||||||<|0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.|||
1717368|NCT00740857|3160641|Superiority or Other||||||<|0.001|||||||Proportional hazards model|Adjusted with treatment, baseline Pain Severity Rating (PSR), and gender terms.|||
1717369|NCT00740831|3160642|Superiority or Other||Median Difference (Net)|-29.9|||<|0.001|2-Sided|95.0|-42.0|-16.6||Since planned analyses involved comparisons of 2 doses of PGL4001 vs GnRH-agonist, a Bonferroni correction was used and p values were doubled (p-value threshold was 0.05) and confidence intervals were similarly adjusted|Cochran-Mantel-Haenszel|Analysed via a Cochran-Mantel-Haenszel test, controlling for strata|||
1717370|NCT00740831|3160642|Superiority or Other||Mean Difference (Net)|-28.3|||<|0.001|2-Sided|95.0|-40.6|-14.6||Since planned analyses involved comparisons of 2 doses of PGL4001 vs GnRH-agonist, a Bonferroni correction was used and p values were doubled (p-value threshold was 0.05) and confidence intervals were similarly adjusted|Cochran-Mantel-Haenszel|Analysed via a Cochran-Mantel-Haenszel test, controlling for strata|||
1717371|NCT00740831|3160643|Superiority or Other||Mean Difference (Net)|-29.9|||<|0.001|2-Sided|95.0|-42.0|-16.6||Since comparisons of 2 doses of ulipristal acetate vs GnRH-agonist, Bonferroni correction was used, p values were doubled (p-value threshold was 0.05) and CI adjusted|Cochran-Mantel-Haenszel|Analysed via Cochran-Mantel-Haenszel test, controlling for strata|||
1717372|NCT00740831|3160643|Superiority or Other||Mean Difference (Net)|-28.3|||<|0.001|2-Sided|95.0|-40.6|-14.6||Since comparisons of 2 doses of ulipristal acetate vs GnRH-agonist, Bonferroni correction was used, p values were doubled (p-value threshold was 0.05) and CI adjusted|Cochran-Mantel-Haenszel|Analysed via Cochran-Mantel-Haenszel test, controlling for strata|||
1717373|NCT00740831|3160644|Non-Inferiority or Equivalence|Non-inferiority|Mean Difference (Final Values)|0.049|||||2-Sided|95.0|-0.043|0.14|||||As comparison of 2 doses of PGL4001 vs GnRH-agonist, Bonneferroni correction used to adjust confidence intervals||
1717374|NCT00740831|3160644|Non-Inferiority or Equivalence|Non-inferiority|Mean Difference (Final Values)|0.089|||||2-Sided|95.0|-0.003|0.181|||||As comparison of 2 doses of PGL4001 vs GnRH-agonist, Bonneferroni correction used to adjust confidence intervals||
1717375|NCT00740831|3160645|Non-Inferiority or Equivalence|Non-inferiority analysis based on the use of one-sided confidence intervals, using 2.5% level of statistical significance.|Difference in proportions|8.8|||||1-Sided|97.5|0.4||||||Newcombe-Wilson method for CI. Percentage in B minus percentage in C needed to be greater than non-inferiority margin of -20%.|As comparison involved two doses of PGL4001 vs GnRH-agonist, Bonferroni correction used to adjust confidence intervals.|
1717376|NCT00740831|3160645|Non-Inferiority or Equivalence|Non-inferiority analysis based on the use of one-sided confidence intervals, using 2.5% level of statistical significance.|Difference in proportions|1.2|||||1-Sided|97.5|-9.3||||||Newcombe-Wilson method for CI. Percentage in A minus percentage in C needed to be greater than non-inferiority margin of -20%.|As comparison involved two doses of PGL4001 vs GnRH-agonist, Bonferroni correction used to adjust confidence intervals.|
1717377|NCT00740727|3160650|Superiority or Other||% subjects with next-day EASI site pain|0.0||||||97.5|0.0|18.5||||||This analysis reports the number of subjects (of 18 possible) who experienced pain, as assessed on next-day follow-up (24 hours after EASI infusion), at the a priori-defined level of at least 3 on a 10-point pain scale.|
1717378|NCT00740727|3160651|Superiority or Other||% of subjects with infusion pain|11.1||||||95.0|1.4|34.7||||||This analysis reports the number of subjects (of 18 possible) who experienced pain, during EASI placement or infusion, at the a priori-defined level of at least 3 on a 10-point pain scale.|
1717379|NCT00740714|3160654|Superiority or Other||Odds Ratio (OR)|9999.98|Standard Error of the Mean|0.0196|<|0.05|2-Sided|95.0|2.51|9999.99|||Fisher Exact||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717380|NCT00740714|3160655|Superiority or Other||Odds Ratio (OR)|9999.98|Standard Error of the Mean|0.0197|<|0.05|2-Sided|95.0|0.48|9999.99|||Fisher Exact||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717381|NCT00740714|3160656|Superiority or Other||Odds Ratio (OR)|1.33|Standard Error of the Mean|0.0198|<|0.05|2-Sided|95.0|0.55|3.24|||Fisher Exact||Odds ratio of >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717526|NCT00737672|3160977|Superiority or Other|||||||0.475|||||||Log Rank||||
1717527|NCT00737672|3160980|Superiority or Other|||||||0.53|||||||Log Rank||||
1717382|NCT00740714|3160657|Superiority or Other||Odds Ratio (OR)|2.26|Standard Error of the Mean|0.0196|<|0.05|2-Sided|95.0|0.64|8.01|||Fisher Exact||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717383|NCT00740714|3160658|Superiority or Other||Odds Ratio (OR)|0.53|Standard Error of the Mean|0.0197|<|0.05|2-Sided|95.0|0.25|1.12|||Fisher Exact||Odds ration >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717384|NCT00740714|3160659|Superiority or Other||Odds Ratio (OR)|9999.98|Standard Error of the Mean|0.0196|<|0.05|2-Sided|95.0|2.77|9999.99|||Fisher Exact||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717385|NCT00740714|3160660|Superiority or Other||Odds Ratio (OR)|0.71|Standard Error of the Mean|0.0197|<|0.05|2-Sided|95.0|0.31|1.62|||Fisher Exact||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717386|NCT00740714|3160661|Superiority or Other||Odds Ratio (OR)|2.44|Standard Error of the Mean|0.0197|<|0.05|2-Sided|95.0|0.69|8.58|||Fisher Exact||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717387|NCT00740714|3160662|Superiority or Other||Odds Ratio (OR)|0.78|Standard Error of the Mean|0.0197|<|0.05|2-Sided|95.0|0.36|1.7|||Fisher Exact||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717388|NCT00740714|3160663|Superiority or Other||Odds Ratio (OR)|0.69|Standard Error of the Mean|0.0197|<|0.05|2-Sided|95.0|0.31|1.52|||Fisher Exact||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717389|NCT00740714|3160664|Superiority or Other||Odds Ratio (OR)|2.8|Standard Error of the Mean|0.0197|<|0.05|2-Sided|95.0|0.81|9.72|||Fisher Exact||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717390|NCT00740714|3160665|Superiority or Other||Odds Ratio (OR)|1.5|Standard Error of the Mean|0.0199|<|0.05|2-Sided|95.0|0.66|3.41|||Fisher Exact||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717391|NCT00740714|3160666|Superiority or Other||Odds Ratio (OR)|0.91|Standard Error of the Mean|0.02|<|0.05|2-Sided|95.0|0.46|1.79|||ANCOVA||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717392|NCT00740714|3160667|Superiority or Other||Odds Ratio (OR)|1.65|Standard Error of the Mean|0.0198|<|0.05|2-Sided|95.0|0.65|4.2|||Fisher Exact||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717393|NCT00740714|3160668|Superiority or Other||Odds Ratio (OR)|1.49|Standard Error of the Mean|0.0198|<|0.05|2-Sided|95.0|0.62|3.57|||Fisher Exact||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subject experiencing a particular adverse experience|
1717394|NCT00740714|3160669|Superiority or Other||Odds Ratio (OR)|1.26|Standard Error of the Mean|0.0199|<|0.05|2-Sided|95.0|0.57|2.8|||Fisher Exact||Odds ratio >1 indicates a higher frequency in active treatment group.|All adverse experiences were tabulated by treatment group, severity and perceived relationship to study medication. Fisher's exact test was used to compare active treatment arms to the placebo arm with regard to the proportion of subjects experiencing a particular adverse experience.|
1717395|NCT00740714|3160670|Superiority or Other||Slope|2.126|Standard Error of the Mean|1.269||0.096|2-Sided|95.0|-0.382|4.633|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the placebo group.|
1717430|NCT00739973|3160733|Superiority or Other||Least Square Mean Difference|-2.63|Standard Error of the Mean|0.92||0.004|2-Sided|95.0|-4.42|-0.83|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717792|NCT00733304|3161955|Superiority||Mean Difference (Net)|2.42|Standard Error of the Mean|18.996|||2-Sided|95.0|-35.5|40.33||||||Month 5 versus Screening visit|
1717396|NCT00740714|3160670|Superiority or Other||Slope|0.631|Standard Error of the Mean|0.608||0.3006|2-Sided|95.0|-0.569|1.831|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 1200 mg/day.|
1717397|NCT00740714|3160670|Superiority or Other||Slope|0.245|Standard Error of the Mean|0.451||0.5889|2-Sided|95.0|-0.647|1.136|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for the treatment group of Coenzyme Q10 2400 mg/day.|
1717398|NCT00740714|3160670|Superiority or Other||Slope|0.536|Standard Error of the Mean|0.282||0.0577|2-Sided|95.0|-0.018|1.091|||ANOVA|The ANOVA is using UPDRS worsening as outcome, Change of CoQ10 level as predictor, adjusting for site and baseline UPDRS score.||The analysis will be using the actual change of plasma levels of CoQ10(from final visit to baseline) as predictors of UPDRS worsening. Correlation of UPDRS worsening with plasma levels of CoQ10 will be calculated for all treatment groups.|
1717399|NCT00740714|3160671|Superiority or Other||Mean Difference (Net)|0.04|Standard Error of the Mean|0.05||0.239||95.0|-0.04|0.14||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided. with a Bonferroni-adjustd significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assess with scatter and residual plots and ITT.||Change from Baseline visit to 16-month visit on Hoehn & Yahr will be analyzed using ANCOVA in the same way as for the primary outcome variable.|
1717400|NCT00740714|3160671|Superiority or Other||Mean Difference (Net)|0.04|Standard Error of the Mean|0.04||0.3445|2-Sided|97.5|-0.04|0.13||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Hoehn & Yahr Score will be analyzed using ANCOVA in the same way as for the primary outcome variable.|
1717401|NCT00740714|3160672|Superiority or Other||Mean Difference (Net)|-0.74|Standard Error of the Mean|1.16||0.671|2-Sided|95.0|-3.34|1.87||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable|
1717402|NCT00740714|3160672|Superiority or Other||Mean Difference (Net)|0.49|Standard Error of the Mean|1.14||0.671|2-Sided|97.5|-2.09|3.06||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Symbol Digit Modalities Test will be analyzed using ANCOVA in the same way as for the primary outcome variable.|
1717403|NCT00740714|3160673|Superiority or Other||Mean Difference (Net)|-0.51|Standard Error of the Mean|1.19||0.667|2-Sided|95.0|-3.2|2.17||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.|
1717404|NCT00740714|3160673|Superiority or Other||Mean Difference (Net)|0.6383|Standard Error of the Mean|1.18||0.6383|2-Sided|97.5|-2.1|3.21||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on PD Quality of Life Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.|
1717405|NCT00740714|3160674|Superiority or Other||Mean Difference (Net)|-0.02|Standard Error of the Mean|0.07||0.7627|2-Sided|95.0|-0.17|0.13||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-Adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plats and ITT.||Change from Baseline Visit to 16-month visit on Modified Rankin will be analyzed using ANCOVA in the same way as for the primary outcome variable.|
1717406|NCT00740714|3160674|Superiority or Other||Mean Difference (Net)|-0.09|Standard Error of the Mean|0.06|<|0.1615|2-Sided|97.5|-0.25|0.06||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Modified Rankin Scale will be analyzed using ANCOVA in the same way as for the primary outcome variable.|
1717431|NCT00739973|3160734|Superiority or Other||Least Square Mean Difference|-6.26|Standard Error of the Mean|0.89|<|0.001|2-Sided|95.0|-8.0|-4.51|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717793|NCT00733304|3161955|Superiority||Mean Difference (Net)|-9.92|Standard Error of the Mean|18.996|||2-Sided|95.0|-47.83|28.0||||||Month 4 versus Screening visit|
1717407|NCT00740714|3160675|Superiority or Other||Mean Difference (Net)|-0.87|Standard Error of the Mean|0.85||0.306||95.0|-2.79|1.04||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month on Modified Schwab & England will be analyzed using ANCOVA in the same way as for the primary outcome variable.|
1717408|NCT00740714|3160675|Superiority or Other||Mean Difference (Net)|-0.22|Standard Error of the Mean|0.84||0.7943|2-Sided|97.5|-2.12|1.68||The primary analysis compares each active treatment arm to the placebo arm. P-Values for efficacy outcomes are 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|COCF is used for missing data and those lost to follow up. Outliers and non-compliant patients are assessed with scatter and residual plots and ITT.||Change from Baseline Visit to 16-month visit on Modified Schwab & England will be analyzed using ANCOVA in the same way as for the primary outcome variable.|
1717409|NCT00740714|3160676|Superiority or Other||Mean Difference (Net)|1.09|Standard Error of the Mean|0.86|>|0.025|2-Sided|95.0|-0.85|3.03||The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|||ANCOVA is used with the change in total UPDRS of Coenzyme Q10 2400 mg/day arm compared to placebo group.|
1717410|NCT00740714|3160676|Superiority or Other||Mean Difference (Net)|0.59|Standard Error of the Mean|0.85|>|0.025|2-Sided|97.5|-1.33|2.51||The primary analysis compares each active treatment arm to the placebo arm. P-values for efficacy outcomes will be 2-sided, with a Bonferroni-adjusted significance level of .025 used to preserve the overall alpha level for the 2 comparisons at .05.|ANCOVA|||ANCOVA is used with the change in total UPDRS of Coenzyme Q10 1200 mg/day arm compared to placebo group.|
1717411|NCT00740207|3160691|Superiority or Other||Mean Difference (Final Values)|-10.0||||1|2-Sided|95.0|-28.6|8.6|||Fisher Exact|||Paired t-test to compare difference in percentage between the number of participants requiring repeat injections|
1717412|NCT00740207|3160692|Superiority or Other||Mean Difference (Final Values)|-40.0||||0.1698|2-Sided|95.0|-79.2|-0.8|||Fisher Exact|||Paired t-test to compare the difference in percentage between the portions of patients who had motion artifacts.|
1717413|NCT00740207|3160693|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.7142|2-Sided|95.0|-1.3|0.9|||t-test, 2 sided|||Paired t-test to compare difference between the investigational product's mean change from predose to postdose|
1717414|NCT00740051|3160697|Superiority or Other||Odds Ratio (OR)|2.801||||0.0046||95.0|1.374|5.711||No adjustment of p-values|Regression, Logistic|||Linagliptin versus Placebo|
1717415|NCT00740051|3160698|Superiority or Other||Odds Ratio (OR)|3.285||||0.1281||95.0|0.71|15.196||No adjustment of p-values|Regression, Logistic|||Linagliptin vs. Placebo|
1717416|NCT00740051|3160699|Superiority or Other||Odds Ratio (OR)|2.576||||0.0374||95.0|1.057|6.279||No adjustment of p-values|Regression, Logistic|||Linagliptin versus Placebo|
1717417|NCT00740051|3160700|Superiority or Other||Mean Difference (Final Values)|-20.5|Standard Error of the Mean|5.4||0.0002||95.0|-31.1|-9.9||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo|
1717418|NCT00740051|3160701|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.14|<|0.0001||95.0|-0.88|-0.32||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo. The primary analysis performed at the interim was re-run at the end of the study to accommodate changes made to the final study database.|
1717419|NCT00740051|3160702|Superiority or Other||Mean Difference (Final Values)|-0.57|Standard Error of the Mean|0.14|<|0.0001||95.0|-0.86|-0.29||No adjustment of p-values|ANCOVA|||Linagliptin versus Placebo|
1717420|NCT00739999|3160720|Superiority or Other||Atorvastatin CL/F based on 70 kg BW|699.0|||||2-Sided|95.0|570.0|881.0||||||Atorvastatin apparent clearance (CL/F) was described as a function of body weight using an allometric equation. The estimated parameter given is an extrapolation of the model for participants who weigh 70 kg.|
1717421|NCT00739973|3160724|Superiority or Other||Least Square Mean Difference|-16.4|Standard Error of the Mean|1.43|<|0.001|2-Sided|95.0|-19.21|-13.6|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717422|NCT00739973|3160725|Superiority or Other||Least Square Mean Difference|-2.16|Standard Error of the Mean|1.47||0.143|2-Sided|95.0|-5.04|0.73|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717423|NCT00739973|3160726|Superiority or Other||Least Square Mean Difference|-7.82|Standard Error of the Mean|1.43|<|0.001|2-Sided|95.0|-10.63|-5.02|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717424|NCT00739973|3160727|Superiority or Other||Least Square Mean Difference|-15.03|Standard Error of the Mean|1.45|<|0.001|2-Sided|95.0|-17.88|-12.2|||ANCOVA||||
1717425|NCT00739973|3160728|Superiority or Other||Least Square Mean Difference|-6.0|Standard Error of the Mean|1.48|<|0.001|2-Sided|95.0|-8.9|-3.11|||ANCOVA|A two-way analysis of covariance model with treatment and region asntwo factors, and the baseline as a covariate.|||
1717426|NCT00739973|3160729|Superiority or Other||Least Square Mean Difference|-6.45|Standard Error of the Mean|1.45|<|0.001|2-Sided|95.0|-9.29|-3.62|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717427|NCT00739973|3160730|Superiority or Other||Least Square Mean Difference|-17.08|Standard Error of the Mean|1.44|<|0.001||95.0|-19.91|-14.3|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717428|NCT00739973|3160731|Superiority or Other||Least Square Mean Difference|-2.83|Standard Error of the Mean|1.48||0.056|2-Sided|95.0|-5.73|-0.07|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717429|NCT00739973|3160732|Superiority or Other||Least Square Mean Difference|-11.1|Standard Error of the Mean|0.89|<|0.001|2-Sided|95.0|-12.85|-9.35|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717879|NCT00730405|3162374|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717432|NCT00739973|3160735|Superiority or Other||Least Square Mean Difference|-9.64|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-11.41|-7.87|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717433|NCT00739973|3160736|Superiority or Other||Least Square Mean Difference|-3.98|Standard Error of the Mean|0.92|<|0.001|2-Sided|95.0|-5.78|-2.18|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717434|NCT00739973|3160737|Superiority or Other||Least Square Mean Difference|-4.79|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-6.56|-3.03|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717435|NCT00739973|3160738|Superiority or Other||Least Square Mean Difference|-10.81|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-12.57|-9.05|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717436|NCT00739973|3160739|Superiority or Other||Least Sqaure Mean Difference|-2.33|Standard Error of the Mean|0.92||0.011|2-Sided|95.0|-4.14|-0.53|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717437|NCT00739973|3160740|Superiority or Other||Least Square Mean Difference|-8.17|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-9.94|-6.4|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717438|NCT00739973|3160741|Superiority or Other||Least Square Mean Difference|-8.63|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-10.39|-6.87|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717439|NCT00739973|3160742|Superiority or Other||Least Square Mean Difference|-2.98|Standard Error of the Mean|0.91||0.001|2-Sided|95.0|-4.77|-1.19|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717440|NCT00739973|3160743|Superiority or Other||Least Square Mean Difference|-6.0|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-7.77|-4.22|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717441|NCT00739973|3160744|Superiority or Other||Least Square Mean Difference|-13.2|Standard Error of the Mean|1.45|<|0.001|2-Sided|95.0|-16.04|-10.4|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717442|NCT00739973|3160745|Superiority or Other||Least Square Mean Difference|-13.85|Standard Error of the Mean|1.44|<|0.001|2-Sided|95.0|-16.68|-11.0|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717443|NCT00739973|3160746|Superiority or Other||Least Square mean Difference|-4.82|Standard Error of the Mean|1.47||0.001|2-Sided|95.0|-7.7|-1.94|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717444|NCT00739973|3160747|Superiority or Other||Least Square Mean Difference|-9.97|Standard Error of the Mean|1.45|<|0.001|2-Sided|95.0|-12.81|-7.12|||ANCOVA|A two-way analysis of covariance model with treatment and region as two factors, and the baseline as a covariate.|||
1717445|NCT00739752|3160781|Superiority||Risk Ratio (RR)|1.16|||<|0.01|2-Sided|95.0|1.05|1.28|||Regression, Poisson|||The 3 vaccine-recommended groups were compared with the 3 vaccine-offered groups using poisson regression.|
1717446|NCT00739752|3160781|Superiority||Risk Ratio (RR)|1.17|||<|0.01|2-Sided|95.0|1.06|1.31|||Regression, Poisson|||Groups receiving any framed interventions (gain-framed or loss-framed) were compared to those in the two non-framed control groups.|
1717447|NCT00739752|3160781|Superiority||Risk Ratio (RR)|0.99|||=|0|2-Sided|95.0|0.88|1.12|||Regression, Poisson|||The two gain-framed groups were compared to the two loss-framed groups using poisson regression.|
1717448|NCT00739674|3160782|Superiority or Other|||||||0.212|||||||Log Rank||||
1717449|NCT00739674|3160783|Superiority or Other|||||||0.026|||||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.|||
1717450|NCT00739674|3160784|Superiority or Other|||||||0.262|||||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.|||
1717451|NCT00739674|3160785|Superiority or Other|||||||0.064|||||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.|||
1717452|NCT00739674|3160786|Superiority or Other|||||||0.158|||||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.|||
1717453|NCT00739674|3160787|Superiority or Other|||||||0.058|||||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.|||
1717454|NCT00739674|3160788|Superiority or Other|||||||0.507|||||||Regression, Linear|Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.|||
1717455|NCT00739674|3160789|Superiority or Other|||||||0.434|||||||Fisher Exact||||
1717456|NCT00739674|3160790|Superiority or Other|||||||0.122|||||||Fisher Exact||||
1717457|NCT00739674|3160791|Superiority or Other|||||||0.092|||||||Fisher Exact||||
1717458|NCT00739674|3160792|Superiority or Other|||||||0.118|||||||Fisher Exact||||
1717459|NCT00739648|3160796|Superiority or Other||Mean Difference (Final Values)|-12.3||||0.9464|2-Sided|90.0|-24.9|0.26|||Mixed Models Analysis||||
1717460|NCT00739648|3160797|Superiority or Other||Median Difference (Final Values)|-15.2||||0.9768|2-Sided|90.0|-27.8|-2.66|||Mixed Models Analysis||||
1717461|NCT00739648|3160799|Superiority or Other||Odds Ratio (OR)|1.09||||0.7282|2-Sided|90.0|0.86|1.39|||Regression, Linear|negative binomial regression model|||
1717462|NCT00739336|3160813|Superiority or Other||||||<|0.01|||||||Mixed Models Analysis|||Piecewise linear multilevel models with multiple observations nested within each participant were used. Random components (intercept, slope) were introduced into the model to account for dependence among measurements within a participant and assessed by nested model comparisons using the deviance statistic (difference in –2LL).|
1717686|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|3.4|||<|0.001|2-Sided|95.0|2.4|5.0||Comparison of HbA1c <7.0% at 104 weeks.|Regression, Logistic||||
1717463|NCT00739297|3160815|Superiority or Other||Difference in Least-Squares Means|0.08||||||95.0|0.01|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717464|NCT00739297|3160815|Superiority or Other||Difference in Least-Squares Means|0.07||||||95.0|-0.02|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717465|NCT00739297|3160815|Superiority or Other||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.1|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717466|NCT00739297|3160815|Superiority or Other||Difference in Least-Squares Means|0.09||||||95.0|0.01|0.17|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717467|NCT00739297|3160815|Superiority or Other||Difference in Least-Squares Means|0.04||||||95.0|-0.03|0.1|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717468|NCT00739297|3160816|Superiority or Other||Difference in Least-Squares Means|0.08||||||95.0|0.01|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717469|NCT00739297|3160816|Superiority or Other||Difference in Least-Squares Means|0.06||||||95.0|-0.03|0.14|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717470|NCT00739297|3160816|Superiority or Other||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717471|NCT00739297|3160816|Superiority or Other||Difference in Least-Squares Means|0.07||||||95.0|0.0|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717472|NCT00739297|3160816|Superiority or Other||Difference in Least-Squares Means|0.06||||||95.0|-0.01|0.12|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717473|NCT00739297|3160817|Superiority or Other||Difference in Least-Squares Means|0.19||||||95.0|0.04|0.34|||||Repeated measures model with terms for treatment (Albuterol/Placebo), dose, treatment-by-dose interaction and baseline FEV1||
1717474|NCT00739297|3160818|Superiority or Other||Difference in Least-Squares Means|0.08||||||95.0|0.04|0.13|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717475|NCT00739297|3160818|Superiority or Other||Difference in Least-Squares Means|0.05||||||95.0|-0.01|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717476|NCT00739297|3160818|Superiority or Other||Difference in Least-Squares Means|0.06||||||95.0|0.02|0.11|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717477|NCT00739297|3160818|Superiority or Other||Difference in Least-Squares Means|0.1||||||95.0|0.04|0.15|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717478|NCT00739297|3160818|Superiority or Other||Difference in Least-Squares Means|0.04||||||95.0|-0.01|0.08|||||Mixed effects model with terms for treatment (including dose of montelukast), period and baseline covariate.||
1717479|NCT00739102|3160819|Superiority or Other||Major adverse event rate (%)|14.4|||||2-Sided|95.0|10.2|19.5|||||||
1717480|NCT00739102|3160822|Superiority or Other||Index Limb Ischemia Rate (%)|8.4||||||95.0|||||||||
1717481|NCT00739102|3160823|Superiority or Other||Primary safety endpoint rate (%)|100.0|||<|0.001|2-Sided|95.0|98.2|100.0|||Agresti-Coull method|||The null hypothesis to be tested was Ho: P = 0.88 against Ha: P > 0.88, where 0.88 was the Objective Performance Criteria (OPC).|
1717482|NCT00739102|3160824|Superiority or Other||Index Limb Ischemia Rate (%)|5.6||||||95.0|||||||||
1717483|NCT00739102|3160825|Superiority or Other||Stent Fracture Rate (%)|1.5|||||2-Sided|95.0|0.3|4.4|||||||
1717484|NCT00739102|3160826|Superiority or Other||Clinically Driven TVR Rate (%)|13.6|||||2-Sided|95.0|9.5|18.6|||||||
1717485|NCT00739102|3160827|Superiority or Other||Clinically Driven TVR Rate (%)|0.0|||||2-Sided|95.0|0.0|1.5|||||||
1717486|NCT00739102|3160828|Superiority or Other||Index Limb Amputation Rate (%)|0.0|||||2-Sided|95.0|0.0|1.5|||||||
1717487|NCT00739102|3160829|Superiority or Other||Death Rate (%)|2.1|||||2-Sided|95.0|0.7|4.9|||||||
1717488|NCT00739102|3160831|Superiority or Other||Proportion - 12-month patency rate|0.665|Standard Error of the Mean|0.032||0.437|2-Sided|95.0|0.6|0.725||The observed rate of primary patency at 12 month was 66.5% (143/215) with a lower 95% confidence interval of 60.0%.|Agresti-Coull method||The 95% confidence intervals and the standard error were calculated using the Agresti-Coull method|The null hypothesis to be tested was Ho: P = 0.66 against Ha: P > 0.66, where 0.66 was the Objective Performance Criteria (OPC). A sample size of 212 subjects was required to achieve 90% power to reject the 66% 12-months patency rate at a one-sided 2.5% significance level when the unknown true patency is at 76%.|
1717489|NCT00738894|3160841|Superiority|This is the second of two primary outcomes for this study. Assumptions for power calculations: expected proportion of brain infarct is 3-7 times the clinical stroke rate; expected brain infarct proportion for medical management 14.5% (2.9% clinical stroke x 5); expected brain infarct for device closure 6.5% (55% risk reduction); 597 subjects (10% attrition from 664) provides 73% power with 1-sided alpha = 0.0125 (based conservatively on a Bonferroni adjustment of alpha/2).|Risk Difference (RD)|0.056||||0.024|2-Sided|95.0|0.003|0.108||1-sided p-value was adjusted for multiplicity with 1st primary outcome using Dubey and Armitage-Parmer (D/AP) procedure.|z-test, 1-sided||Unadjusted for multiplicity.|"Test null hypothesis of equal or higher proportion with brain infarct for device closure compared to medical management.~H0: Pm - Pd ≤ 0, versus H1: Pm - Pd > 0, where Pd and Pm are true proportions of subjects with brain infarct for the device closure and medical management arms.~Significance threshold (1-sided alpha) = 0.025."|
1717518|NCT00738062|3160929|Superiority or Other|||||||0.438|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.|||
1717519|NCT00737711|3160965|Superiority or Other||||||<|0.0001||||||Paired t-test was used to estimation of p-value.|t-test, 2 sided||||
1717520|NCT00737672|3160967|Superiority or Other||||||<|0.001|||||||Fisher Exact|Two-tailed.|||
1717521|NCT00737672|3160968|Superiority or Other||||||<|0.001|||||||Fisher Exact|Two-tailed.|||
1717490|NCT00738894|3160842|Superiority|This is the first of two primary outcomes for this study. Assumptions for power calculations: expected event free for medical management 92% at 24 months; expected event free for device closure 96.4% at 24 months (55% risk reduction); 664 subjects randomly assigned 2:1 to device closure or medical management provides 80% power with 15% attrition (over 5 years) and 1-sided alpha = 0.024 to allow for interim analysis (interim analysis later rescinded from plan).|Hazard Ratio (HR)|0.23||||0.001|2-Sided|95.0|0.09|0.62||1-sided p-value was adjusted for multiplicity with 2nd primary outcome using Dubey and Armitage-Parmer (D/AP) procedure.|Log Rank||Hazard ratio (test/control) obtained from Cox proportional hazards model with treatment arm as sole explanatory variable, the exponentiated coefficient of which provided the hazard ratio. Unadjusted for multiplicity.|"Test null hypothesis of equal or lower recurrent stroke-free survivorship for device closure compared to medical management.~H0: Sd(t) ≤ Sm(t) for all t, versus H1: Sd(t) > Sm(t) for all t, where Sd(t) and Sm(t) are true Kaplan-Meier product-limit survivor functions for the device closure and medical management arms and t is time from randomization to event or censoring.~Event-free subjects were censored at time of last follow-up. Significance threshold (1-sided alpha) = 0.025."|
1717491|NCT00738699|3160850|Superiority or Other||Difference|-7.4||||0.0399|2-Sided|95.0|-14.1|-0.7||Compared the ratio of complete or partial responders in the two arms. Stratified by route of administration for first line therapy and geographic region as specified at baseline.|Cochran-Mantel-Haenszel||(FAR + Paclitaxel) minus (Placebo + Paclitaxel). Confidence interval based on a normal approximation to the binomial distribution.||
1717492|NCT00738699|3160851|Superiority or Other||Cox Proportional Hazard|1.11||||0.7568|2-Sided|95.0|0.83|1.48||One-sided log rank test stratified by route of administration for primary chemotherapy and geographic region.|Log Rank||Stratified as described above||
1717493|NCT00738699|3160852|Superiority or Other||Cox Proportional Hazard|1.13||||0.836|2-Sided|95.0|0.88|1.46||One-sided log rank test stratified by route of administration for primary chemotherapy (intraperitoneal vs intravenous) and geographic region (North America, Europe, and other participating countries).|Log Rank||Stratified as described above.||
1717494|NCT00738543|3160867|Non-Inferiority or Equivalence|The minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL.|||||<|0.05||||||Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.|Kruskal-Wallis|2 degrees of freedom corrected for ties||The null hypothesis established that the 3 medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used. The alpha level for significance was established at 5%. A minimal sample of 20 volunteers was calculated for a power of 80%, and bilateral error of 5%.|
1717495|NCT00738543|3160869|Non-Inferiority or Equivalence|A minimal sample of 20 volunteers was calculated to to find a difference of 200 CFU/mL, with a power of 80% and bilateral error of 5%.|||||<|0.05||||||Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.|Kruskal-Wallis|2 degrees of freedom corrected for ties||The null hypothesis established that the three medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used.|
1717496|NCT00738530|3160872|Superiority or Other||Difference in response rates|19.9|||<|0.0001|2-Sided|95.0|13.2|26.6|||Chi-squared||||
1717497|NCT00738530|3160873|Superiority or Other||Hazard Ratio (HR)|0.78||||0.0023|2-Sided|95.0|0.66|0.92|||Log Rank||||
1717498|NCT00738530|3160875|Superiority or Other||Hazard Ratio (HR)|0.73||||0.0002|2-Sided|95.0|0.62|0.86|||Log Rank||||
1717499|NCT00738530|3160876|Superiority or Other||Hazard Ratio (HR)|0.75||||0.0004|2-Sided|95.0|0.64|0.88|||Log Rank||||
1717500|NCT00738530|3160878|Superiority or Other||Hazard Ratio (HR)|0.91||||0.336|2-Sided|95.0|0.76|1.1|||Log Rank||||
1717501|NCT00738400|3160882|Superiority or Other||Mean Difference (Final Values)|-27.33|||<|0.0001||95.0|-37.24|-17.43|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint|
1717502|NCT00738400|3160883|Superiority or Other||Mean Difference (Final Values)|-15.57||||0.0003||95.0|-23.8|-7.34|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint|
1717503|NCT00738400|3160884|Superiority or Other|||||||0.0004|||||||Mantel Haenszel|||Mantel-Haenszel Test|
1717504|NCT00738400|3160885|Superiority or Other||Mean Difference (Final Values)|-26.16|||<|0.0001||95.0|-37.48|-14.83|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint|
1717505|NCT00738400|3160886|Superiority or Other||Mean Difference (Final Values)|-20.71|||<|0.0001||95.0|-30.66|-10.76|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint|
1717506|NCT00738400|3160887|Superiority or Other||Mean Difference (Final Values)|-6.76|||<|0.0001||95.0|-9.03|-4.49|||ANCOVA|||ANCOVA, baseline covariate, endpoint week 8 or LOCF. Factors: treatment, pooled centers. Ls mean at endpoint|
1717507|NCT00738374|3160890|Superiority or Other|||||||0.2712|||||||Log Rank||||
1717508|NCT00738374|3160906|Superiority or Other|||||||0.0795|||||||Chi-squared||||
1717509|NCT00738374|3160907|Superiority or Other|||||||0.0008|||||||Chi-squared|||Analysis compared responders and non-responders.|
1717510|NCT00738062|3160921|Superiority or Other|||||||0.33|||||||Fisher Exact||||
1717511|NCT00738062|3160922|Superiority or Other|||||||0.252|||||||Fisher Exact||||
1717512|NCT00738062|3160923|Superiority or Other|||||||0.873|||||||Fisher Exact||||
1717513|NCT00738062|3160924|Superiority or Other|||||||0.708|||||||Fisher Exact||||
1717514|NCT00738062|3160925|Superiority or Other|||||||0.251|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.|||
1717515|NCT00738062|3160926|Superiority or Other|||||||0.286|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Item 1 value at randomization.|||
1717516|NCT00738062|3160927|Superiority or Other|||||||0.198|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHSA Composite value at baseline.|||
1717517|NCT00738062|3160928|Superiority or Other|||||||0.554|||||||Mantel Haenszel|Mantel-Haenszel statistic comparing treatment groups based on rank statistics adjusted for the covariate OHDAS Composite value at randomization.|||
1717528|NCT00737568|3160998|Superiority or Other|||||||0.43||||||The p-value for the two-sided Cochran-Mantel-Haenszel test was controlled for strata (HBeAg status and ALT level).|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference between the FTC/TDF and TDF treatment groups. The alternative hypothesis is that there is a difference between the FTC/TDF and TDF treatment groups. These hypotheses were evaluated using a Cochran-Mantel-Haenszel (CMH) test, controlling for randomization strata, with the missing = failure method in which participants with missing data were considered to have failed to achieve the endpoint.|
1717529|NCT00737464|3161039|Superiority or Other||Mean Difference (Final Values)|0.52|||||2-Sided||||||||||
1717530|NCT00737204|3161050|Superiority or Other||||||>=|0|||||||Paired t-tests|||Null hypothesis: CD4 levels for both the Armodafinil and Placebo groups will not change significantly between baseline and week 4.|
1717531|NCT00737204|3161051|Superiority or Other|||||||0.01|||||||ANCOVA|||Repeated measure analysis|
1717532|NCT00737204|3161052|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1717533|NCT00737178|3161053|Superiority or Other|||||||0.24|||||||Chi-squared||||
1717534|NCT00737178|3161055|Superiority or Other||||||<|0.01|||||||Chi-squared||||
1717535|NCT00737100|3161063|Superiority or Other||Odds Ratio (OR)|0.72||||0.5565||95.0|0.33|1.59|||Regression, Logistic|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo|
1717536|NCT00737100|3161063|Superiority or Other||Odds Ratio (OR)|0.79||||0.8515||95.0|0.37|1.72|||Regression, Logistic|Covariates of treatment and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo|
1717537|NCT00737100|3161064|Superiority or Other||Mean Difference (Final Values)|0.05||||0.1418||95.0|-0.02|0.12|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo|
1717538|NCT00737100|3161064|Superiority or Other||Mean Difference (Final Values)|0.01||||0.7414||95.0|-0.06|0.08|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo|
1717539|NCT00737100|3161065|Superiority or Other||Mean Difference (Final Values)|5.34||||0.0073||95.0|1.45|9.23|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo|
1717540|NCT00737100|3161065|Superiority or Other||Mean Difference (Final Values)|4.19||||0.0363||95.0|0.27|8.11|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo|
1717541|NCT00737100|3161066|Superiority or Other||Mean Difference (Final Values)|1.19||||0.2199||95.0|-0.72|3.11|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo|
1717542|NCT00737100|3161066|Superiority or Other||Mean Difference (Final Values)|0.85||||0.3857||95.0|-1.08|2.79|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo|
1717543|NCT00737100|3161067|Superiority or Other||Mean Difference (Final Values)|3.12||||0.0023||95.0|1.12|5.12|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo|
1717544|NCT00737100|3161067|Superiority or Other||Mean Difference (Final Values)|1.83||||0.0756||95.0|-0.19|3.86|||Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo|
1717545|NCT00737100|3161068|Superiority or Other||Mean Difference (Final Values)|2.22||||0.0179||95.0|0.38|4.06||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo|
1717546|NCT00737100|3161068|Superiority or Other||Mean Difference (Final Values)|2.24||||0.0184||95.0|0.38|4.11||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo|
1717547|NCT00737100|3161069|Superiority or Other||Mean Difference (Final Values)|3.39||||0.0001||95.0|1.67|5.12||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 5.0 microgram dose versus placebo|
1717548|NCT00737100|3161069|Superiority or Other||Mean Difference (Final Values)|2.94||||0.001||95.0|1.19|4.7||Comment for p-value: Hierarchical testing was applied. Comparison of 2.5 dose to be performed only if superiority of tiotropium 5.0 dose compared to placebo was shown for both primary endpoints.|Mixed Models Analysis|Adjusted for baseline, center, visit and age group||Comparison of Tiotropium 2.5 microgram dose versus placebo|
1717549|NCT00737061|3161070|Superiority or Other||Pregnancy Prevention Rate|98.4||||||95.0|96.9|99.1||||||"2-sided Confidence Interval~No hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment)."|
1717550|NCT00737061|3161070|Superiority or Other||Pregnancy Prevention Rate|98.4||||||95.0|97.2|100.0||||||"1-sided Confidence Interval.~No hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment)."|
1717551|NCT00737061|3161080|Superiority or Other||Pregnancy Prevention Rate|98.9||||||95.0|97.6|99.5||||||2-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 2-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).|
1717552|NCT00737061|3161080|Superiority or Other||Pregnancy Prevention Rate|98.9||||||95.0|97.9|100.0||||||1-sided confidence interval. No statistical hypothesis testing was performed. Confidence interval represents a 1-sided confidence interval for the pregnancy prevention rate in the EASE Trial. 95% confidence interval derived using Kaplan Meier methods (log-log with PETO adjustment).|
1717880|NCT00730405|3162374|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717553|NCT00737048|3161092|Superiority or Other||Mean Difference (Final Values)|-4.3|Standard Deviation|7.99|<|0.0001|||||||Fisher Least Signiﬁcant Diﬀerence Method|||Statistical Analysis 2 for Total pain relief based on numerical rating scale score|
1717554|NCT00737048|3161092|Superiority or Other||Mean Difference (Final Values)|-5.3|Standard Deviation|8.06|<|0.0001|||||||Fisher Least Signiﬁcant Diﬀerence Method|||Statistical Analysis 1 for Total pain relief based on numerical rating scale score|
1717555|NCT00736996|3161093|Superiority or Other||||||<|0.05|||||||Regression, Linear|||The mean change with EET was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.|
1717556|NCT00736996|3161093|Superiority or Other||||||<|0.05|||||||Regression, Linear|||The mean change with PIO was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.|
1717557|NCT00736996|3161094|Superiority or Other||||||<|0.05|||||||Regression, Linear|||The mean change with EET was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.|
1717558|NCT00736996|3161094|Superiority or Other||||||<|0.05|||||||Regression, Linear|||The mean change with PIO was compared with the mean change with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline level of the outcome variable.|
1717559|NCT00736996|3161095|Superiority or Other||||||<|0.0125||||||Statistical significance was defined as a 2-sided p-value < 0.0125 (=0.05/4) to adjust for multiple comparisons.|Regression, Linear|||The mean change in domain score with EET was compared with the mean change in domain score with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline domain score.|
1717560|NCT00736996|3161095|Superiority or Other||||||<|0.0125||||||Statistical significance was defined as a 2-sided p-value < 0.0125 (=0.05/4) to adjust for multiple comparisons.|Regression, Linear|||The mean change in domain score with PIO was compared with the mean change in domain score with Placebo in a linear regression conditioned on the stratification categories (MCI subtype and number of APOE ε4 alleles) and the baseline domain score.|
1717561|NCT00736879|3161130|Superiority or Other||Mean Difference (Final Values)|-1.47|Standard Error of the Mean|0.8238|||2-Sided|95.0|-3.09|0.16||||||Following a sequential testing procedure, this comparison was not statistically tested, ie, the previous comparison did not meet the criterion for statistical significance.|
1717562|NCT00736879|3161130|Superiority or Other||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.8154|||2-Sided|95.0|-2.22|0.99||||||Following a sequential testing procedure, this comparison was not statistically tested, ie, the previous comparison did not meet the criterion for statistical significance.|
1717563|NCT00736879|3161130|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.7954||0.3163|2-Sided|95.0|-2.37|0.77||Test was performed at alpha=0.05.|ANCOVA||||
1717564|NCT00736879|3161131|Superiority or Other||Percent Difference|14.5|Standard Error of the Mean|8.069||0.0726|2-Sided|95.0|-1.3|30.3||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).|
1717565|NCT00736879|3161131|Superiority or Other||Percent Difference|8.8|Standard Error of the Mean|7.65||0.2512|2-Sided|95.0|-6.2|23.8||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).|
1717566|NCT00736879|3161131|Superiority or Other||percent difference|18.9|Standard Error of the Mean|7.38||0.0157|2-Sided|95.0|3.6|34.3||Test was performed at alpha=0.05.|Regression, Logistic|Logistic regression based on the methodology of Zhang, Tsiatis and Davidian and Tsiatis, Davidian, Zhang and Lu, with adjustment for baseline HbA1c.||The probability of response was modeled using a logistic regression model with baseline HbA1c as the covariate. Treatment group estimates of response rate were then obtained by integrating each group's modeled probability of response over the observed distribution of baseline covariate (combined across groups).|
1717567|NCT00736879|3161132|Superiority or Other||Mean Difference (Final Values)|-60.6|Standard Error of the Mean|9.1796|<|0.0001|2-Sided|95.0|-78.67|-42.5||Test was performed at alpha=0.05.|ANCOVA||||
1717568|NCT00736879|3161132|Superiority or Other||Mean Difference (Final Values)|-48.1|Standard Error of the Mean|9.1963|<|0.0001|2-Sided|95.0|-66.27|-30.03||Test was performed at alpha=0.05.|ANCOVA||||
1717569|NCT00736879|3161132|Superiority or Other||Mean Difference (Final Values)|-42.1|Standard Error of the Mean|8.8681|<|0.0001|2-Sided|95.0|-59.56|-24.61||Test was performed at alpha=0.05.|ANCOVA||||
1717570|NCT00736879|3161133|Superiority or Other||Mean Difference (Final Values)|-32.6|Standard Error of the Mean|5.962|<|0.0001|2-Sided|95.0|-44.3|-20.8||Test was performed at alpha=0.05.|ANCOVA||||
1717571|NCT00736879|3161133|Superiority or Other||Mean Difference (Final Values)|-25.7|Standard Error of the Mean|5.816|<|0.0001|2-Sided|95.0|-37.2|-14.3||Test was performed at alpha=0.05.|ANCOVA||||
1717572|NCT00736879|3161133|Superiority or Other||Mean Difference (Final Values)|-15.1|Standard Error of the Mean|5.859|<|0.0103|2-Sided|95.0|-26.7|-3.6||Test was performed at alpha=0.05.|ANCOVA||||
1717573|NCT00736879|3161134|Superiority or Other||Mean Difference (Final Values)|-1.73|Standard Error of the Mean|0.5598||0.0022|2-Sided|95.0|-2.83|-0.63||Test was performed at alpha=0.05.|ANCOVA||||
1717574|NCT00736879|3161134|Superiority or Other||Mean Difference (Final Values)|-1.68|Standard Error of the Mean|0.5474||0.0024|2-Sided|95.0|-2.76|-0.6||Test was performed at alpha=0.05.|ANCOVA||||
1717687|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|2.7|||<|0.001|2-Sided|95.0|1.8|3.9||Comparison of HbA1c <7.0% at 52 weeks.|Regression, Logistic||||
1717575|NCT00736879|3161134|Superiority or Other||Mean Difference (Final Values)|-1.73|Standard Error of the Mean|0.5481||0.0018|2-Sided|95.0|-2.81|-0.65||Test was performed at alpha=0.05.|ANCOVA|||By applying sequential testing procedure, the testing was performed since the primary endpoint was significant.|
1717576|NCT00736879|3161135|Superiority or Other||Mean Difference (Final Values)|-0.84|Standard Error of the Mean|0.171|<|0.0001|2-Sided|95.0|-1.17|-0.5|||ANCOVA|Tested at alpha=0.019 applying Dunnett’s adjustment.|||
1717577|NCT00736879|3161135|Superiority or Other||Mean Difference (Final Values)|-0.74|Standard Error of the Mean|0.1679|<|0.0001|2-Sided|95.0|-1.07|-0.41|||ANCOVA|Tested at alpha=0.019 applying Dunnett’s adjustment.|||
1717578|NCT00736879|3161135|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.1672|<|0.0001|2-Sided|95.0|-1.02|-0.37||Tested at alpha=0.019 applying Dunnett’s adjustment|ANCOVA||||
1717579|NCT00736853|3161158|Superiority or Other||Hazard Ratio (HR)|0.377||||0.0001|2-Sided|95.0|0.221|0.641|||Log Rank|Stratified Log-rank test with the target disease as the stratification factor|||
1717580|NCT00736840|3161159|Non-Inferiority or Equivalence|Sample size was calculated to enable the testing of both study hypotheses (together) with at least 80% power. Our best estimate of sensitivity of the HIS diagnosis in the population, was 0.9 and its specificity 0.79. Requiring a power of 90% for each of the hypotheses and a 5% level of significance, to test the null hypotheses 173 cirrhotic and 241 non-cirrhotic subjects were needed.Therefore a total of at least 414 subjects were required.|AUC ROC|0.785|Standard Error of the Mean|0.0485|<|0.0001|2-Sided|95.0|0.737|0.834|||Regression, Logistic||||
1717581|NCT00736840|3161160|Non-Inferiority or Equivalence|Provided above|Sensitivity|0.74|Standard Error of the Mean|0.0363||0.0924|2-Sided|95.0|0.6607|0.8809|||Exact binomial test|||The null hypothesis was sensitivity lower than 0.8. We assumed a sensitivity of 0.89 and required a power of 90% to test the hypothesis at a 5% level of significance, and calculated that 173 cirrhotic and 241 non-cirrhotic subjects were needed (for a one-sample binomial test of outcome versus constant).|
1717582|NCT00736645|3161162|Other|||||||0.9727|||||||Wilcoxon (Mann-Whitney)||||
1717583|NCT00736645|3161162|Other|||||||0.7504|||||||Wilcoxon (Mann-Whitney)||||
1717584|NCT00736645|3161162|Other|||||||0.2609|||||||Wilcoxon (Mann-Whitney)||||
1717585|NCT00736645|3161163|Other|||||||0.3463|||||||Wilcoxon (Mann-Whitney)||||
1717586|NCT00736645|3161163|Other|||||||0.8994|||||||Wilcoxon (Mann-Whitney)||||
1717587|NCT00736645|3161163|Other|||||||0.5137|||||||Wilcoxon (Mann-Whitney)||||
1717588|NCT00736255|3161228|Superiority or Other|||||||0.54|||||||Chi-squared|||"Null Hypothesis:LDX and NRT will not facilitate smoking cessation compared to NRT and placebo.~Alternate Hypothesis: LDX and NRT will facilitate smoking cessation compared to NRT and placebo.~This is a one tailed, proof of concept study so there is no formal power analysis, however if we see a signal for treatment effect, we would like to do further investigation by conducting a separate trial."|
1717589|NCT00736229|3161239|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Median time (hours) to steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.|
1717590|NCT00736229|3161239|Superiority or Other||||||<|0.8|||||||Wilcoxon (Mann-Whitney)|||Median time (hours) to steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.|
1717591|NCT00736229|3161239|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||Median Time (Hrs) to steady state was evaluated across the three groups (exenatide, moderate and intensive) with a Kruskal-Wallis test.|
1717592|NCT00736229|3161240|Superiority or Other|||||||0.15||||||Comparison of Median Glucose Values between Exenatide and Moderate Groups.|Wilcoxon (Mann-Whitney)|||Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Moderate study groups using a Wilcoxon Rank Sum tests.|
1717593|NCT00736229|3161240|Superiority or Other||||||<|0.001||||||Comparison of Median Glucose Values between Exenatide and Intensive Groups.|Wilcoxon (Mann-Whitney)|||Median Glucose Values (mg/dl) after steady state were evaluated between the Exenatide and Intensive study groups using a Wilcoxon Rank Sum tests.|
1717594|NCT00736229|3161240|Superiority or Other||||||<|0.001||||||Comparison for the difference in Median glucose values during steady state across all three groups.|Kruskal-Wallis|||Median Glucose Values (mg/dl) after steady state were evaluated across the three groups (Exenatide,Moderate and Intensive) with a Kruskal-Wallis test.|
1717595|NCT00736125|3161253|Superiority||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1717596|NCT00736125|3161254|Equivalence|nonparametric data were analyzed using Mann Whitney U Tests|||||>|0.05|||||||t-test, 2 sided||||
1717597|NCT00735787|3161361|Superiority or Other|||||||0.014|||||||Fisher Exact|||The primary null hypothesis for this study was that there was no difference in the proportion of subjects that achieved PGA clear or almost clear at Week 16 between the adalimumab and placebo groups. Analysis was done using a two-sided Fisher's exact test at alpha level=0.05.|
1717598|NCT00735709|3161382|Superiority or Other||Odds Ratio (OR)|1.753||||0.062|2-Sided|95.0|0.973|3.158|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1717599|NCT00735709|3161382|Superiority or Other||Odds Ratio (OR)|2.056||||0.015|2-Sided|95.0|1.15|3.673|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1717600|NCT00735709|3161382|Superiority or Other||Odds Ratio (OR)|1.951||||0.026|2-Sided|95.0|1.082|3.517|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline MADRS score.|||
1717601|NCT00735709|3161383|Superiority or Other||LS Mean Difference|-4.13||||0.004|2-Sided|95.0|-6.9|-1.37|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|||
1717602|NCT00735709|3161383|Superiority or Other||LS Mean Difference|-4.47||||0.002|2-Sided|95.0|-7.32|-1.62|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|||
1717603|NCT00735709|3161383|Superiority or Other||LS Mean Difference|-4.59||||0.001|2-Sided|95.0|-7.34|-1.84|||Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|||
1717604|NCT00735709|3161384|Superiority or Other||Odds Ratio (OR)|3.018|||<|0.001|2-Sided|95.0|1.799|5.063|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo||
1717605|NCT00735709|3161384|Superiority or Other||Odds Ratio (OR)|2.739|||<|0.001|2-Sided|95.0|1.631|4.598|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo||
1717606|NCT00735709|3161384|Superiority or Other||Odds Ratio (OR)|3.348|||<|0.001|2-Sided|95.0|1.995|5.618|||Regression, Logistic|Regression with explanatory variables for treatment and Baseline HAM-D24 score.|Odds ratio versus placebo.||
1717607|NCT00735709|3161385|Superiority or Other||LS Mean Difference|-0.47|||<|0.001|2-Sided|95.0|-0.72|-0.23|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|||
1717608|NCT00735709|3161385|Superiority or Other||LS Mean Difference|-0.47|||<|0.001|2-Sided|95.0|-0.71|-0.22|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|||
1717609|NCT00735709|3161385|Superiority or Other||LS Mean Difference|-0.55|||<|0.001|2-Sided|95.0|-0.8|-0.3|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|||
1717610|NCT00735709|3161386|Superiority or Other||LS Mean Difference|-0.05||||0.963|2-Sided|95.0|-2.03|1.94|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|||
1717611|NCT00735709|3161386|Superiority or Other||LS Mean Difference|-1.11||||0.263|2-Sided|95.0|-3.07|0.84|||Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|||
1717612|NCT00735709|3161386|Superiority or Other||LS Mean Difference|-1.54||||0.135|2-Sided|95.0|-3.56|0.48||Pre-specified sequential statistical testing procedure indicates that when p-value >0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|||
1717613|NCT00735709|3161387|Superiority or Other||LS Mean Difference|-3.52|||<|0.001|2-Sided|95.0|-5.57|-1.47||This treatment arm is not in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|||
1717614|NCT00735709|3161387|Superiority or Other||LS Mean Difference|-4.12|||<|0.001|2-Sided|95.0|-6.17|-2.08||Hierarchical testing stopped at SDS total score at Week 8 in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.|||
1717615|NCT00735709|3161387|Superiority or Other||LS Mean Difference|-4.93|||<|0.001|2-Sided|95.0|-6.99|-2.86||Pre-specified sequential statistical testing procedure indicates that when p-value <0.05, hierarchical testing continues.|Mixed model for repeated measurements|P-values are from an MMRM model with Baseline-by-week, center, week, and week-by-treatment as factors in the analysis.||All statistical tests were 2-sided with the estimated P-values at the 5% level of significance. To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.|
1717616|NCT00735670|3161397|Superiority or Other||REML|-0.31||||0.725|2-Sided|95.0|-0.48|-0.15||Comparison of venlafaxine vs. placebo on change of PHQ-9 over time controlling for baseline PHQ-9 score.|Mixed Models Analysis|||A linear mixed model (LMM) analysis was used and included a random intercept effect based on lowest Akaike’s Information Criterion values when we compared three random coefficient models (intercept, slope and intercept and slope). To examine whether allocation group influenced the effect of time and baseline PHQ-9 sore on the trajectory of PHQ-9 scores, we included two interaction terms (time by allocation group and baseline PHQ-9 score by allocation group).|
1717617|NCT00735670|3161398|Superiority or Other|||||||0.445|||||||Fisher Exact||||
1717618|NCT00735371|3161431|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1717619|NCT00735371|3161431|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1717620|NCT00735371|3161431|Superiority or Other||||||<|0.0235|||||||Cochran-Mantel-Haenszel||||
1717621|NCT00735371|3161432|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1717622|NCT00735371|3161432|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1717623|NCT00735371|3161432|Superiority or Other||||||<|0.0056|||||||ANCOVA||||
1717624|NCT00735072|3161437|Superiority or Other|||||||0.014|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there will be no difference in the week 24 change in %activated CD8+ T cells between arms. Assuming a standard deviation as high as 3.5% and a Type I error of 5%, with 21 subjects in each treatment arm we would have 80% statistical power to detect a mean 3 percentage-point difference in the percent of activated CD8+ T cells between the active drug and placebo groups.|
1717625|NCT00734747|3161503|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1717626|NCT00734656|3161510|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||null hypothesis - A single 4 mg dose of dutasteride does not reduce serum 3a-androstanediol glucuronide levels|
1717627|NCT00734656|3161511|Superiority or Other|||||||0.17|||||||Mixed Models Analysis|||null hypothesis: dutasteride pre-treatment does not reduce the stimulating effect of alcohol|
1717628|NCT00734656|3161512|Superiority or Other|||||||0.01|||||||Mixed Models Analysis|||null hypothesis: dutasteride pre-treatment does not reduce the sedative effect of alcohol|
1717629|NCT00734656|3161513|Superiority or Other|||||||0.28|||||||t-test, 2 sided|||null hypothesis - dutasteride does not affect blood alcohol following standardized dose of alcohol (0.8 gr/kg)|
1717630|NCT00734604|3161517|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.06||0.637|2-Sided|95.0|-0.14|0.09||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model||||
1717631|NCT00734604|3161517|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.06||0.07|2-Sided|95.0|-0.01|0.22||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model||||
1717632|NCT00734604|3161518|Superiority or Other||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.07|<|0.001|2-Sided|95.0|-0.43|-0.16||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model||||
1717633|NCT00734604|3161518|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.07|<|0.001|2-Sided|95.0|-0.65|-0.37||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model||||
1717634|NCT00734604|3161519|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.06||0.722|2-Sided|95.0|-0.15|0.1||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model||||
1717635|NCT00734604|3161519|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.06||0.002|2-Sided|95.0|0.07|0.32||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model||||
1717636|NCT00734604|3161520|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.08||0.367|2-Sided|95.0|-0.08|0.23||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in LS Means.|Generalized Linear Mixed Model||||
1717637|NCT00734604|3161520|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.08||0.403|2-Sided|95.0|-0.09|0.22||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in LS Means.|Generalized Linear Mixed Model||||
1717638|NCT00734604|3161521|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|1.04||0.212|2-Sided|95.0|-3.35|0.74||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717639|NCT00734604|3161521|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|1.05||0.915|2-Sided|95.0|-1.95|2.17||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717640|NCT00734604|3161523|Superiority or Other||Mean Difference (Final Values)|-3.55|Standard Error of the Mean|1.27||0.006|2-Sided|95.0|-6.05|-1.04||p-value is for the difference between Tadalafil OaD and Tadalafil PRN change in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717641|NCT00734604|3161523|Superiority or Other||Mean Difference (Final Values)|3.66|Standard Error of the Mean|1.27||0.004|2-Sided|95.0|1.16|6.17||p-value is for the difference between Tadalafil PRN and Sildenafil PRN change in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717642|NCT00734604|3161524|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.11||0.046|2-Sided|95.0|-0.44|0.0||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717643|NCT00734604|3161524|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.11||0.055|2-Sided|95.0|-0.44|0.0||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717644|NCT00734604|3161525|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-0.78|-0.23||p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test||||
1717645|NCT00734604|3161525|Superiority or Other||Mean Difference (Final Values)|-0.64|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-0.91|-0.36||p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717646|NCT00734604|3161526|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.01|<|0.001|2-Sided|95.0|0.06|0.12||p-value is for difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717647|NCT00734604|3161526|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.01|<|0.001|2-Sided|95.0|0.03|0.09||p-value is for difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717648|NCT00734604|3161527|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.29||0.007|2-Sided|95.0|-1.37|-0.22||p-value is for the difference between Tadalafil OaD and Tadalafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717649|NCT00734604|3161527|Superiority or Other||Mean Difference (Final Values)|-0.85|Standard Error of the Mean|0.3||0.004|2-Sided|95.0|-1.43|-0.27||p-value is for the difference between Tadalafil OaD and Sildenafil PRN Change from Baseline in LS Means.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717650|NCT00734604|3161528|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.03|<|0.001|2-Sided|95.0|-0.2|-0.08||p-value is for the difference between Tadalafil OaD and Tadalafil PRN in Change from Baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717651|NCT00734604|3161528|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.03|<|0.001|2-Sided|95.0|-0.36|-0.25||p-value is for the difference between Tadalafil OaD and Sildenafil PRN in Change from Baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717652|NCT00734604|3161529|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.03||0.395|2-Sided|95.0|-0.03|0.07||p-value is for difference between Tadalafil OaD and Tadalafil PRN in change from baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717653|NCT00734604|3161529|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.03|<|0.001|2-Sided|95.0|0.1|0.2||p-value is for difference between Tadalafil OaD and Sildenafil PRN change from baseline in LS Mean.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717654|NCT00734604|3161530|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.04||0.872|2-Sided|95.0|-0.06|0.08||p-value is for difference in Pairs Sexual Self-Confidence Domain Score LS Mean and Change from Baseline between Tadalafil OaD and Tadalafil PRN Population|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|LS Mean difference = Tadalafil OaD-Tadalafil PRN||
1717655|NCT00734604|3161531|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.04||0.001|2-Sided|95.0|0.04|0.19||p-value is for difference in LS Means change from baseline between tadalafil OaD and Sildenafil PRN.|t-test|Kenward-Roger approximation was used for denominator degrees of freedom in the mixed model.|||
1717656|NCT00734591|3161532|Superiority or Other||Exact method|3.75|||||2-Sided|95.0|1.01|20.68|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.||
1717657|NCT00734591|3161533|Superiority or Other||Cox Proportional Hazard|0.81|||||2-Sided|95.0|0.6|1.1|||||||
1717658|NCT00734591|3161534|Superiority or Other||Exact method|2.29|||||2-Sided|95.0|0.37|24.01|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.||
1717659|NCT00734591|3161535|Superiority or Other||Exact method|2.81|||||2-Sided|95.0|0.5|28.46|||||Incidence density ratio confidence interval derived from exact methods utilizing exact binomial limits and ratio of exposures.||
1717660|NCT00734578|3161536|Superiority or Other|||||||0.502||||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.|
1717661|NCT00734578|3161536|Superiority or Other|||||||0.971||||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.|
1717662|NCT00734578|3161537|Superiority or Other||Placebo-adjusted difference in LS mean|-4.7||||0.002||95.0|-7.6|-1.7||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.|
1717663|NCT00734578|3161537|Superiority or Other||Placebo-adjusted difference in LS mean|-5.1|||<|0.001||95.0|-8.0|-2.2||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.|
1717664|NCT00734578|3161538|Superiority or Other||Placebo-adjusted difference in LS mean|-2.2||||0.003||95.0|-3.6|-0.7||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.|
1717665|NCT00734578|3161538|Superiority or Other||Placebo-adjusted difference in LS mean|-2.4||||0.001||95.0|-3.9|-0.9||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.|
1717666|NCT00734578|3161539|Superiority or Other||||||<|0.001||||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.|
1717667|NCT00734578|3161539|Superiority or Other||||||<|0.001||||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.|
1717668|NCT00734578|3161540|Superiority or Other||Placebo-adjusted difference in LS mean|-3.0|||<|0.001||95.0|-4.5|-1.5||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.|
1717669|NCT00734578|3161540|Superiority or Other||Placebo-adjusted difference in LS mean|-2.4|||<|0.002||95.0|-4.0|-0.9||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.|
1717670|NCT00734578|3161541|Superiority or Other||Placebo-adjusted difference in LS mean|-2.6|||<|0.001||95.0|-4.0|-1.1||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.|
1717671|NCT00734578|3161541|Superiority or Other||Placebo-adjusted difference in LS mean|-1.7|||<|0.019||95.0|-3.2|-0.3||No adjustments for multiple comparisons.|ANCOVA|||Not powered for secondary outcome measures.|
1717672|NCT00734578|3161542|Superiority or Other||||||<|0.001||||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.|
1717673|NCT00734578|3161542|Superiority or Other||||||<|0.013||||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.|
1717674|NCT00734578|3161543|Superiority or Other|||||||0.003||||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.|
1717675|NCT00734578|3161543|Superiority or Other|||||||0.024||||||No adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||Not powered for secondary outcome measures.|
1717676|NCT00734578|3161544|Superiority or Other||Placebo-adjusted difference in LS mean|-5.3|||<|0.001||95.0|-8.3|-2.3||Both SPD503 groups were compared with placebo using Dunnett's adjustment. Each treatment comparison was evaluated at the 0.05 significance level (Dunnett's adjusted).|ANCOVA|||The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.|
1717677|NCT00734578|3161544|Superiority or Other||Placebo-adjusted difference in LS mean|-4.5|||<|0.002||95.0|-7.5|-1.4||Both SPD503 groups were compared with placebo using Dunnett's adjustment. Each treatment comparison was evaluated at the 0.05 significance level (Dunnett's adjusted).|ANCOVA|||The null hypothesis stated that there was no difference between SPD503 AM or placebo and that there was no difference between SPD503 PM or placebo. 90% power was needed to detect an effect size of at least 0.4 between either SPD503 group and placebo.|
1717678|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|2.4|||<|0.001|2-Sided|95.0|1.5|3.7||Comparison of HbA1c ≤6.5% at 104 weeks.|Regression, Logistic||||
1717679|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|5.2|||<|0.001|2-Sided|95.0|3.4|7.9||Comparison of HbA1c ≤6.5% at 104 weeks.|Regression, Logistic||||
1717680|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|2.3|||<|0.001|2-Sided|95.0|1.5|3.5||Comparison of HbA1c ≤6.5% at 52 weeks.|Regression, Logistic||||
1717681|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|4.4|||<|0.001|2-Sided|95.0|2.9|6.8||Comparison of HbA1c ≤6.5% at 52 weeks.|Regression, Logistic||||
1717682|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|2.3|||<|0.005|2-Sided|95.0|1.3|4.1||Comparison of HbA1c ≤6.5 at 26 weeks.|Regression, Logistic||||
1717683|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|5.0|||<|0.001|2-Sided|95.0|2.8|8.8||Comparison of HbA1c ≤6.5% at 26 weeks.|Regression, Logistic||||
1717684|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|11.5|||<|0.001|2-Sided|95.0|6.5|20.4||Comparison of HbA1c ≤6.5% at 26 weeks.|Regression, Logistic||||
1717685|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|2.3|||<|0.001|2-Sided|95.0|1.6|3.3||Comparison of HbA1c <7.0% at 104 weeks.|Regression, Logistic||||
1717881|NCT00730405|3162374|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717688|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|4.0|||<|0.001|2-Sided|95.0|2.7|5.9||Comparison of HbA1c <7.0% at 52 weeks.|Regression, Logistic||||
1717689|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|3.0|||<|0.001|2-Sided|95.0|1.8|4.8||Comparison of HbA1c <7.0% at 26 weeks.|Regression, Logistic||||
1717690|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|8.6|||<|0.001|2-Sided|95.0|5.2|14.3||Comparison of HbA1c <7.0% at 26 weeks.|Regression, Logistic||||
1717691|NCT00734474|3161581|Superiority or Other||Odds Ratio (OR)|11.3|||<|0.001|2-Sided|95.0|6.8|18.8||Comparison of HbA1c <7.0% at 26 weeks.|Regression, Logistic||||
1717692|NCT00734474|3161582|Superiority or Other||LS Mean Difference|-0.54||||0.256|2-Sided|95.0|-1.48|0.4||Comparison at 104 weeks.|Mixed Models Analysis||||
1717693|NCT00734474|3161582|Superiority or Other||LS Mean Difference|-1.36||||0.005|2-Sided|95.0|-2.3|-0.42||Comparison at 104 weeks.|Mixed Models Analysis||||
1717694|NCT00734474|3161582|Superiority or Other||LS Mean Difference|-0.59||||0.128|2-Sided|95.0|-1.36|0.17||Comparison at 52 weeks.|Mixed Models Analysis||||
1717695|NCT00734474|3161582|Superiority or Other||LS Mean Difference|-1.46|||<|0.001|2-Sided|95.0|-2.23|-0.69||Comparison at 52 weeks.|Mixed Models Analysis||||
1717696|NCT00734474|3161582|Superiority or Other||LS Mean Difference|-0.25|||<|0.512|2-Sided|95.0|-1.01|0.5||Comparison at 26 weeks.|Mixed Models Analysis||||
1717697|NCT00734474|3161582|Superiority or Other||LS Mean Difference|-0.58|||<|0.133|2-Sided|95.0|-1.34|0.18||Comparison at 26 weeks.|Mixed Models Analysis||||
1717698|NCT00734474|3161582|Superiority or Other||LS Mean Difference|-1.69|||<|0.001|2-Sided|95.0|-2.45|-0.93||Comparison at 26 weeks.|Mixed Models Analysis||||
1717699|NCT00734474|3161584|Superiority or Other||LS Mean Difference|-0.64||||0.054|2-Sided|95.0|-1.29|0.01||Comparison at 104 weeks.|ANCOVA||||
1717700|NCT00734474|3161584|Superiority or Other||LS Mean Difference|-1.14|||<|0.001|2-Sided|95.0|-1.78|-0.49||Comparison at 104 weeks.|ANCOVA||||
1717701|NCT00734474|3161584|Superiority or Other||LS Mean Difference|-1.07|||<|0.001|2-Sided|95.0|-1.65|-0.48||Comparison at 52 weeks.|ANCOVA||||
1717702|NCT00734474|3161584|Superiority or Other||LS Mean Difference|-1.5|||<|0.001|2-Sided|95.0|-2.08|-0.92||Comparison at 52 weeks.|ANCOVA||||
1717703|NCT00734474|3161584|Superiority or Other||LS Mean Difference|0.02|||<|0.953|2-Sided|95.0|-0.54|0.58||Comparison at 26 weeks.|ANCOVA||||
1717704|NCT00734474|3161584|Superiority or Other||LS Mean Difference|-1.16|||<|0.001|2-Sided|95.0|-1.73|-0.6||Comparison at 26 weeks.|ANCOVA||||
1717705|NCT00734474|3161584|Superiority or Other||LS Mean Difference|-1.7|||<|0.001|2-Sided|95.0|-2.27|-1.14||Comparison at 26 weeks.|ANCOVA||||
1717706|NCT00734474|3161586|Superiority or Other||LS Mean Difference|21.28||||0.039|2-Sided|95.0|1.03|41.53||Comparison at 104 weeks.|Mixed Models Analysis||||
1717707|NCT00734474|3161586|Superiority or Other||LS Mean Difference|11.07||||0.291|2-Sided|95.0|-9.49|31.64||Comparison at 104 weeks.|Mixed Models Analysis||||
1717708|NCT00734474|3161586|Superiority or Other||LS Mean Difference|8.77||||0.273|2-Sided|95.0|-6.94|24.47||Comparison at 52 weeks.|Mixed Models Analysis||||
1717709|NCT00734474|3161586|Superiority or Other||LS Mean Difference|6.38||||0.43|2-Sided|95.0|-9.49|22.26||Comparison at 52 weeks.|Mixed Models Analysis||||
1717710|NCT00734474|3161586|Superiority or Other||LS Mean Difference|15.41||||0.167|2-Sided|95.0|-6.47|37.29||Comparison at 26 weeks.|Mixed Models Analysis||||
1717711|NCT00734474|3161586|Superiority or Other||LS Mean Difference|17.08||||0.121|2-Sided|95.0|-4.54|38.69||Comparison at 26 weeks.|Mixed Models Analysis||||
1717712|NCT00734474|3161586|Superiority or Other||LS Mean Difference|18.51||||0.095|2-Sided|95.0|-3.25|40.28||Comparison at 26 weeks.|Mixed Models Analysis||||
1717713|NCT00734474|3161587|Superiority or Other||LS Mean Difference|-0.92|||<|0.001|2-Sided|95.0|-1.33|-0.51||Comparison at 104 weeks.|Mixed Models Analysis||||
1717714|NCT00734474|3161587|Superiority or Other||LS Mean Difference|-1.51|||<|0.001|2-Sided|95.0|-1.93|-1.1||Comparison at 104 weeks.|Mixed Models Analysis||||
1717715|NCT00734474|3161587|Superiority or Other||LS Mean Difference|-0.73|||<|0.001|2-Sided|95.0|-1.07|-0.39||Comparison at 52 weeks.|Mixed Models Analysis||||
1717716|NCT00734474|3161587|Superiority or Other||LS Mean Difference|-1.47|||<|0.001|2-Sided|95.0|-1.82|-1.13||Comparison at 52 weeks.|Mixed Models Analysis||||
1717717|NCT00734474|3161587|Superiority or Other||LS Mean Difference|-0.48|||<|0.012|2-Sided|95.0|-0.86|-0.11||Comparison at 26 weeks.|Mixed Models Analysis||||
1717718|NCT00734474|3161587|Superiority or Other||LS Mean Difference|-1.48|||<|0.001|2-Sided|95.0|-1.85|-1.1||Comparison at 26 weeks.|Mixed Models Analysis||||
1717719|NCT00734474|3161587|Superiority or Other||LS Mean Difference|-1.89|||<|0.001|2-Sided|95.0|-2.27|-1.51|||Mixed Models Analysis|Comparison at 26 weeks.|||
1717720|NCT00734474|3161589|Superiority or Other||LS Mean Difference|-0.39|||<|0.001|2-Sided|95.0|-0.56|-0.22||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis|
1717721|NCT00734474|3161589|Superiority or Other||LS Mean Difference|-0.67|||<|0.001|2-Sided|95.0|-0.84|-0.5||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis|
1717722|NCT00734474|3161589|Non-Inferiority or Equivalence|Family-wise Type I error rate controlled by applying gatekeeping strategy.|LS Mean Difference|-0.39|||<|0.001|2-Sided|95.0|-0.56|-0.22||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA||||
1717723|NCT00734474|3161589|Non-Inferiority or Equivalence|Family-wise Type I error rate was controlled by applying a gatekeeping strategy.|LS Mean Difference|-0.67|||<|0.001|2-Sided|95.0|-0.84|-0.5||Comparison at 104 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA||||
1717724|NCT00734474|3161589|Superiority or Other||LS Mean Difference|-0.64|||<|0.001|2-Sided|95.0|-0.81|-0.48||Comparison at 26 weeks. One-sided raw p-value with no adjustment for multiplicity.|ANCOVA||||
1717725|NCT00734474|3161589|Superiority or Other||LS Mean Difference|-1.05|||<|0.001|2-Sided|95.0|-1.21|-0.88||Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis|
1717726|NCT00734474|3161589|Superiority or Other||LS Mean Difference|-1.26|||<|0.001|2-Sided|95.0|-1.42|-1.09||Comparison at 26 weeks. P-value adjusted for multiplicity based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis|
1717727|NCT00734474|3161591|Superiority or Other||LS Mean Difference|-0.47|||<|0.001|2-Sided|95.0|-0.63|-0.31||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis|
1717728|NCT00734474|3161591|Superiority or Other||LS Mean Difference|-0.71|||<|0.001|2-Sided|95.0|-0.87|-0.55||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Superiority analysis|
1717729|NCT00734474|3161591|Non-Inferiority or Equivalence|Family-wise Type I error rate was controlled by applying a gatekeeping strategy.|LS Mean Difference|-0.47|||<|0.001|2-Sided|95.0|-0.63|-0.31||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Power was estimated at approximately 89% based on a simulation study using the “most likely” pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used.|
1717730|NCT00734474|3161591|Non-Inferiority or Equivalence|Family-wise Type I error rate was controlled by applying gatekeeping strategies.|LS Mean Difference|-0.71|||<|0.001|2-Sided|95.0|-0.87|-0.55||P-value is adjusted for multiplicity, based on tree-gatekeeping strategy. To determine significance, p-value is compared to the family-wise 1-sided Type I error of 0.025. The confidence interval is not adjusted for multiplicity.|ANCOVA|||Power was estimated at approximately 89% based on a simulation study using the “most likely” pharmacodynamic model, assuming a 20% drop out rate (missing completely at random) at 52 weeks and enrollment of 5 participants per week. A predictive power calculation was planned to select either 263 or 333 as the minimum total sample size needed (sum of Stage 1 and 2) per arm. If the predictive power of the higher LY2189265 dose based on 263 participants in total exceeded 85%, then 263 would be used.|
1717731|NCT00734162|3161671|Superiority or Other||||||<|0.001||||||A p-value of < 0.05 was considered statistically significant.|Cochran-Mantel-Haenszel|||Analysis is the difference between treatment groups in the proportion of participants who met the outcome measure criterion, controlling for randomization age group.|
1717732|NCT00734071|3161705|Superiority or Other||LS Mean Difference|1.02|Standard Error of the Mean|2.951||0.731|2-Sided|95.0|-4.79|6.83||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements||||
1717733|NCT00734071|3161706|Superiority or Other||LS Mean Difference|-0.01|Standard Error of the Mean|1.558||0.995|2-Sided|95.0|-3.09|3.07||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements||||
1717734|NCT00734071|3161707|Superiority or Other||Odds Ratio (OR)|1.131||||0.602|2-Sided|95.0|0.713|1.795|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.|||
1717735|NCT00734071|3161708|Superiority or Other||LS Mean Difference|0.33|Standard Error of the Mean|0.866||0.703|2-Sided|95.0|-1.38|2.04||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements||||
1717736|NCT00734071|3161709|Superiority or Other||LS Mean Difference|0.0|Standard Error of the Mean|0.141||0.984|2-Sided|95.0|-0.27|0.28||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P<0.05). No adjustments for multiplicity were made.|Mixed model for repeated measurements||||
1717737|NCT00734071|3161710|Superiority or Other||LS Mean Difference|-0.22|Standard Error of the Mean|0.542||0.685|2-Sided|95.0|-1.29|0.85||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|||Statistical tests were 2-sided and results were presented with 95% confidence intervals with the estimated P-values at the 5% level of significance (ie, statistical significance if P<0.05).|
1717738|NCT00734071|3161711|Superiority or Other||LS Mean Difference|0.59|Standard Error of the Mean|0.911||0.518|2-Sided|95.0|-1.2|2.38||Pre-specified sequential statistical testing procedure indicates that when p-value >0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|||P-values were tested at the 5% level of significance (ie, statistical significance if P<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.|
1717739|NCT00734032|3161714|Superiority||Ratio|0.326|||<|0.001|2-Sided|95.0|0.284|0.375|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 160 mg. Dunnett adjustment was used for comparison of each dose group to placebo.||
1717791|NCT00733304|3161955|Superiority||Mean Difference (Net)|9.05|Standard Error of the Mean|20.931|||2-Sided|95.0|-33.09|51.2||||||Month 1 versus Screening visit|
1717740|NCT00734032|3161714|Superiority||Ratio|0.421|||<|0.001|2-Sided|95.0|0.367|0.483|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 80 mg. Dunnett adjustment was used for comparison of each dose group to placebo.||
1717741|NCT00734032|3161714|Superiority||Ratio|0.514|||<|0.001|2-Sided|95.0|0.449|0.59|||ANCOVA||The point estimate was calculated as adjusted geometric mean ratio of placebo and SB-480848 40 mg. Dunnett adjustment was used for comparison of each dose group to placebo.||
1717742|NCT00733980|3161730|Superiority or Other||Mean Difference (Net)|0.1167||||0.932|2-Sided|80.0|-1.6387|1.8722|||ANCOVA||||
1717743|NCT00733980|3161731|Superiority or Other||Mean Difference (Net)|3.4466||||0.361|2-Sided|80.0|-1.3986|8.2917|||ANCOVA||||
1717744|NCT00733980|3161732|Superiority or Other||Logistic Model|0.9211||||0.8156|2-Sided|80.0|0.5863|1.4471|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 6/ Early withdrawal|
1717745|NCT00733980|3161732|Superiority or Other||Odds Ratio (OR)|0.7347||||0.4088|2-Sided|80.0|0.4554|1.1853|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 4|
1717746|NCT00733980|3161732|Superiority or Other||Odds Ratio (OR)|0.6359||||0.3588|2-Sided|80.0|0.3378|1.1968|||Logistic Model|||GSK561679 350 mg Vs Placebo, Week 2|
1717747|NCT00733980|3161736|Superiority or Other||Mean Difference (Net)|0.7283||||0.55|2-Sided|80.0|-0.8353|2.292|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6|
1717748|NCT00733980|3161736|Superiority or Other||Mean Difference (Net)|1.6473||||0.116|2-Sided|80.0|0.3078|2.9868|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4|
1717749|NCT00733980|3161736|Superiority or Other||Mean Difference (Net)|1.0524||||0.249|2-Sided|80.0|-0.1194|2.2243|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2|
1717750|NCT00733980|3161736|Superiority or Other||Mean Difference (Net)|0.644||||0.355|2-Sided|80.0|-0.2498|1.5378|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1|
1717751|NCT00733980|3161737|Superiority or Other||Mean Difference (Net)|-0.6273||||0.801|2-Sided|80.0|-3.8337|2.5791|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6|
1717752|NCT00733980|3161737|Superiority or Other||Mean Difference (Net)|0.8107||||0.721|2-Sided|80.0|-2.1036|3.7251|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4|
1717753|NCT00733980|3161737|Superiority or Other||Mean Difference (Net)|-0.3242||||0.867|2-Sided|80.0|-2.8165|2.1681|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 3|
1717754|NCT00733980|3161737|Superiority or Other||Mean Difference (Net)|-0.2538||||0.889|2-Sided|80.0|-2.5922|2.0846|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2|
1717755|NCT00733980|3161737|Superiority or Other||Mean Difference (Net)|-1.9866||||0.181|2-Sided|80.0|-3.8876|-0.0856|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1|
1717756|NCT00733980|3161738|Superiority or Other||Mean Difference (Net)|0.6327||||0.599|2-Sided|80.0|-0.9135|2.1789|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 6|
1717757|NCT00733980|3161738|Superiority or Other||Mean Difference (Net)|1.5363||||0.156|2-Sided|80.0|0.1485|2.9241|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 4|
1717758|NCT00733980|3161738|Superiority or Other||Mean Difference (Net)|0.7638||||0.409|2-Sided|80.0|-0.4243|1.9519|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 2|
1717759|NCT00733980|3161738|Superiority or Other||Mean Difference (Net)|0.9495||||0.209|2-Sided|80.0|-0.0185|1.9175|||Mixed Models Analysis|||GSK561679 350 mg Vs Placebo, Week 1|
1717760|NCT00733980|3161739|Superiority or Other||Mean Difference (Net)|0.9413||||0.095|2-Sided|80.0|0.2203|1.6624|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 4|
1717761|NCT00733980|3161739|Superiority or Other||Mean Difference (Net)|0.4299||||0.386|2-Sided|80.0|-0.2063|1.0661|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 2|
1717762|NCT00733980|3161739|Superiority or Other||Mean Difference (Net)|-0.0169||||0.966|2-Sided|80.0|-0.5231|0.4893|||Mixed Models Analysis|||GSK561679 Vs Placebo, Week 1|
1717763|NCT00733980|3161740|Superiority or Other||Mean Difference (Net)|0.2479||||0.703||80.0|-0.5887|1.0846|||Mixed-Model Repeated-Measure analysis||||
1717764|NCT00733499|3161775|Other|||||||0.9813|||||||t-test, 2 sided||||
1717765|NCT00733499|3161776|Other|||||||0.0485|||||||t-test, 2 sided||||
1717766|NCT00733499|3161777|Other|||||||0.9637|||||||t-test, 2 sided||||
1717767|NCT00733499|3161778|Other|||||||0.9042|||||||t-test, 2 sided||||
1717768|NCT00733499|3161779|Other|||||||0.1076|||||||t-test, 2 sided||||
1717769|NCT00733499|3161780|Other|||||||0.6896|||||||t-test, 2 sided||||
1717770|NCT00733499|3161781|Other|||||||0.0062|||||||Wilcoxon (Mann-Whitney)||||
1717771|NCT00733499|3161782|Other|||||||0.2935|||||||t-test, 2 sided||||
1717772|NCT00733499|3161784|Other|||||||0.4776|||||||t-test, 2 sided||||
1717773|NCT00733499|3161785|Other|||||||0.2116|||||||t-test, 2 sided||||
1717774|NCT00733499|3161786|Other|||||||0.8955|||||||t-test, 2 sided||||
1717775|NCT00733499|3161787|Other|||||||0.3317|||||||t-test, 2 sided||||
1717776|NCT00733499|3161788|Other|||||||0.8007|||||||t-test, 2 sided||||
1717777|NCT00733499|3161789|Other|||||||0.4779|||||||t-test, 2 sided||||
1717778|NCT00733499|3161790|Other|||||||0.6801|||||||Wilcoxon (Mann-Whitney)||||
1717779|NCT00733499|3161791|Other|||||||0.0883|||||||t-test, 2 sided||||
1717780|NCT00733499|3161792|Other|||||||0.0327|||||||t-test, 2 sided||||
1717781|NCT00733499|3161793|Other|||||||0.0629|||||||t-test, 2 sided||||
1717782|NCT00733499|3161794|Other|||||||0.0513|||||||t-test, 2 sided||||
1717783|NCT00733499|3161795|Other|||||||0.3549|||||||t-test, 2 sided||||
1717784|NCT00733499|3161796|Other|||||||0.5312|||||||t-test, 2 sided||||
1717785|NCT00733499|3161797|Other|||||||0.549|||||||t-test, 2 sided||||
1717786|NCT00733499|3161798|Other|||||||0.9478|||||||t-test, 2 sided||||
1717787|NCT00733304|3161955|Superiority||Mean Difference (Net)|-2.16|Standard Error of the Mean|21.757|||2-Sided|95.0|-45.83|41.51||||||Month 5 versus Screening visit|
1717788|NCT00733304|3161955|Superiority||Mean Difference (Net)|-16.82|Standard Error of the Mean|22.183|||2-Sided|95.0|-61.28|27.63||||||Month 4 versus Screening visit|
1717789|NCT00733304|3161955|Superiority||Mean Difference (Net)|15.39|Standard Error of the Mean|21.757|||2-Sided|95.0|-28.28|59.06||||||Month 3 versus Screening visit|
1717790|NCT00733304|3161955|Superiority||Mean Difference (Net)|-1.24|Standard Error of the Mean|21.29|||2-Sided|95.0|-44.05|41.57||||||Month 2 versus Screening visit|
1717794|NCT00733304|3161955|Superiority||Mean Difference (Net)|-5.11|Standard Error of the Mean|17.958|||2-Sided|95.0|-41.08|30.86||||||Month 3 versus Screening visit|
1717795|NCT00733304|3161955|Superiority||Mean Difference (Net)|-1.21|Standard Error of the Mean|17.177|||2-Sided|95.0|-35.73|33.31||||||Month 2 versus Screening visit|
1717796|NCT00733304|3161955|Superiority||Mean Difference (Net)|8.28|Standard Error of the Mean|16.899|||2-Sided|95.0|-25.72|42.29||||||For Month 1 versus Screening visit|
1717797|NCT00733304|3161956|Superiority||Mean Difference (Net)|-4.03|Standard Error of the Mean|1.74|||2-Sided|95.0|-7.53|0.53||||||Month 5 versus screening visit|
1717798|NCT00733304|3161956|Superiority||Mean Difference (Net)|-4.15|Standard Error of the Mean|1.672|||2-Sided|95.0|-7.52|-0.78||||||Month 2 versus screening visit|
1717799|NCT00733304|3161956|Superiority||Mean Difference (Net)|-3.8|Standard Error of the Mean|1.659|||2-Sided|95.0|-7.13|-0.46||||||Month 5 versus screening visit|
1717800|NCT00733304|3161956|Superiority||Mean Difference (Net)|-0.43|Standard Error of the Mean|1.362|||2-Sided|95.0|-3.18|2.31||||||Month 2 versus screening visit|
1717801|NCT00733226|3161985|Superiority or Other||Mean Difference (Final Values)|-1.22|Standard Error of the Mean|0.82||0.452|2-Sided|95.0|-2.87|0.42||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)||||
1717802|NCT00733226|3161986|Superiority or Other||Median Difference (Final Values)|-0.25|Standard Error of the Mean|0.14||0.195|2-Sided|95.0|-0.55|0.03||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)||||
1717803|NCT00733226|3161987|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.22||0.11|2-Sided|95.0|-0.77|0.11||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)||||
1717804|NCT00733226|3161988|Superiority or Other||Median Difference (Final Values)|-2.11|Standard Error of the Mean|0.41|<|0.001|2-Sided|95.0|-2.94|-1.27|||Wilcoxon (Mann-Whitney)|P value was not need to adjusted for multiple comparisons|||
1717805|NCT00733226|3161989|Superiority or Other||Mean Difference (Final Values)|-2.08|Standard Error of the Mean|0.49|<|0.001|2-Sided|95.0|-3.06|-1.01||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)||||
1717806|NCT00733226|3161990|Superiority or Other||Mean Difference (Final Values)|-2.15|Standard Error of the Mean|0.52||0.05|2-Sided|95.0|-3.2|-1.1||P value was not need to adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||The sample size was computed to prove that a 30% decrease of the rate of virus provoked wheezing attacks in the OM-85 group compared with placebo is statistically significant. Approximately 29 analyzable participants in each group were required, with α=0.05 and β=0.10 (ie, with a power of 90%), respectively. The difference of 30% was taken from both pilot study and clinical experience. Sample size estimation was performed by using NCSS and PASS 2000 software.|
1717807|NCT00733135|3161996|Superiority or Other||||||<|0.05|||||||GEE||||
1717808|NCT00733005|3162001|Superiority or Other|||||||0.019|||||||ANCOVA||||
1717809|NCT00733005|3162002|Superiority or Other|||||||0.102|||||||ANCOVA||||
1717810|NCT00732758|3162052|Superiority or Other|||||||0.35|||||||t-test, 2 sided||||
1717811|NCT00732758|3162053|Superiority or Other|||||||0.66|||||||t-test, 2 sided||||
1717812|NCT00732758|3162054|Superiority or Other|||||||0.51|||||||t-test, 2 sided|unadjusted p-values|||
1717813|NCT00732758|3162055|Superiority or Other|||||||0.003|||||||ANCOVA|adjusting for baseline 25(OH)D, race, BMI, diet vitamin D, gender, pubertal status, and sunlight exposure.|||
1717814|NCT00732615|3162068|Superiority or Other||Odds Ratio (OR)|0.879||||0.747|2-Sided|95.0|0.402|1.922||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the second secondary endpoint reached statistical significance.|Cochran-Mantel-Haenszel|||The null hypothesis is that the percentages of subjects with any reported clinical symptoms for the two treatment arms are the same.|
1717815|NCT00732615|3162069|Superiority or Other||Odds Ratio (OR)|11.711|||<|0.001|2-Sided|95.0|2.619|52.363||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the first secondary endpoint reached statistical significance.|Cochran-Mantel-Haenszel|||The null hypothesis is that there is no difference between the proportions of subjects (who achieved this secondary endpoint) from the two treatment arms.|
1717816|NCT00732615|3162070|Superiority or Other||||||<|0.001||||||Following fixed sequence test procedure described in the primary endpoint section, statistical hypothesis testing was conducted for this secondary endpoint after the testing for the primary endpoint reached statistical significance.|ANCOVA|ANCOVA analysis conducted using percentage change from baseline as dependent variable, treatment as factor, and baseline calcium dose as covariate.||The null hypothesis is that there is no difference between the percentage changes from baseline for the two treatment arms.|
1717817|NCT00732615|3162071|Superiority or Other||Treatment difference|52.3|||<|0.001|2-Sided|95.0|40.6|64.0||A fixed sequence test procedure was used to control the study level type I error. Order of test sequence started with the primary efficacy endpoint and proceeded to the 3 secondary efficacy endpoints, in the order defined in the protocol.|Fisher Exact|The 2-sided Fisher’s Exact test was utilized to test for difference between NPSP558 and the placebo treatment groups.|The above two sided asymptotic 95% confidence interval is based on normal approximation.|The null hypothesis is that the % of subjects meeting primary efficacy endpoint criteria are the same for both tmt arms. The sample size was determined based on the assumption that 40% and 10% of subjects for NPSP558 and pbo arms would meet the endpt criteria, respectively. Based on 2-tailed test, alpha of 0.05 and 2-to-1 randomization ratio, 84 (56 NPSP558, 28 pbo) subjects who completing the study would achieve 80% statistical power. Adjusted for dropouts, planned enrollment was 110 subjects.|
1717818|NCT00732472|3162095|Superiority or Other||Mean Difference (Final Values)|7.06|Standard Error of the Mean|2.642|||2-Sided|95.0|1.57|12.54|||||Day 7, WM||
1717819|NCT00732472|3162095|Superiority or Other||Mean Difference (Final Values)|6.16|Standard Error of the Mean|2.282|||2-Sided|95.0|1.51|10.81|||||Day 1, WM||
1717820|NCT00732472|3162095|Superiority or Other||Mean Difference (Final Values)|-2.51|Standard Error of the Mean|2.378|||2-Sided|95.0|-7.48|2.45|||||Day 7, WM||
1717821|NCT00732472|3162095|Superiority or Other||Mean Difference (Final Values)|2.33|Standard Error of the Mean|2.182|||2-Sided|95.0|-2.12|6.77|||||Day 1, WM||
1717822|NCT00732472|3162095|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|2.52|||2-Sided|95.0|-5.09|5.4|||||Day 7, WM||
1717823|NCT00732472|3162095|Superiority or Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|2.243|||2-Sided|95.0|-4.8|4.34|||||Day 1, WM||
1717824|NCT00732472|3162095|Superiority or Other||Mean Difference (Final Values)|8.7|Standard Error of the Mean|3.079|||2-Sided|95.0|2.34|15.05|||||Day 7, Max HR||
1717825|NCT00732472|3162095|Superiority or Other||Mean Difference (Final Values)|7.49|Standard Error of the Mean|2.899|||2-Sided|95.0|1.59|13.39|||||Day 1, Max HR||
1717826|NCT00732472|3162095|Superiority or Other||Mean Difference (Final Values)|-2.25|Standard Error of the Mean|2.729|||2-Sided|95.0|-7.89|3.39|||||Day 7, Max HR||
1717827|NCT00732472|3162095|Superiority or Other||Mean Difference (Final Values)|3.27|Standard Error of the Mean|2.772|||2-Sided|95.0|-2.37|8.91|||||Day 1, Max HR||
1717828|NCT00732472|3162095|Superiority or Other||Mean Difference (Final Values)|1.25|Standard Error of the Mean|2.922|||2-Sided|95.0|-4.78|7.28|||||Day 7, Max HR||
1717829|NCT00732472|3162095|Superiority or Other||Mean Difference (Final Values)|2.26|Standard Error of the Mean|2.777|||2-Sided|95.0|-3.39|7.91|||||Day 1, Max HR||
1717830|NCT00732381|3162099|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1717831|NCT00732381|3162100|Superiority or Other|||||||0.006|||||||ANCOVA||||
1717832|NCT00732199|3162123|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1717833|NCT00732199|3162124|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1717834|NCT00732199|3162125|Superiority or Other||||||<|0.05|||||||ANOVA|Compares control vs hypoxia trials vs recovery post-hypoxia|||
1717835|NCT00732199|3162126|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||T- test was conducted to compare the 2 groups.|
1717836|NCT00731822|3162193|Superiority or Other||Least Squares Mean Difference|0.6|||||2-Sided|95.0|-3.9|5.1|||||||
1717837|NCT00731783|3162194|Superiority or Other||Odds Ratio (OR)|0.43||||0.02|2-Sided|95.0|0.22|0.86|||Fisher Exact||||
1717838|NCT00731783|3162195|Superiority or Other||Odds Ratio (OR)|0.39||||0.008|2-Sided|95.0|0.2|0.77|||Fisher Exact||||
1717839|NCT00731783|3162196|Superiority or Other||Odds Ratio (OR)|0.42||||0.02|2-Sided|95.0|0.21|0.85|||Fisher Exact||||
1717840|NCT00731783|3162197|Superiority or Other||Odds Ratio (OR)|0.52||||0.12|2-Sided|95.0|0.23|1.16|||Fisher Exact||||
1717841|NCT00731783|3162198|Superiority or Other||Odds Ratio (OR)|1.59||||0.28|2-Sided|95.0|0.77|3.28|||Fisher Exact||||
1717842|NCT00731783|3162199|Superiority or Other||Odds Ratio (OR)|0.77||||0.49|2-Sided|95.0|0.39|1.52|||Fisher Exact||||
1717843|NCT00731783|3162200|Superiority or Other||Odds Ratio (OR)|2.17||||0.05|2-Sided|95.0|1.03|4.55|||Fisher Exact||||
1717844|NCT00731783|3162201|Superiority or Other||Odds Ratio (OR)|1.03||||1|2-Sided|95.0|0.54|1.97|||Fisher Exact||||
1717845|NCT00731692|3162223|Superiority or Other||Cox Proportional Hazard|0.95||||0.544|2-Sided|95.0|0.8|1.12|||Regression, Cox||||
1717846|NCT00731679|3162224|Superiority or Other (legacy)|||||||0.005|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.|||
1717847|NCT00731679|3162225|Superiority or Other (legacy)|||||||0.01|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.|||
1717848|NCT00731614|3162235|Superiority or Other (legacy)|||||||0.322|||||||Repeated Measure ANOVA|||Conducted a repeated measures ANOVA comparing CBT+mirror retraining with Supportive Therapy across 11 time points. The primary hypothesis was a group by time interaction. Due to missing data, a total of 9 and 14 participants, respectively could be included in analyses.|
1717849|NCT00731133|3162260|Superiority or Other||Slope|-0.373|Standard Error of the Mean|0.2196||0.05|2-Sided|95.0|-0.8075|0.0615|||Mixed Models Analysis|7,24||Open label study testing changes in amphetamine use over time (i.e., slope).|
1717850|NCT00731133|3162261|Superiority or Other||Slope|2.6466|Standard Error of the Mean|0.9016||0.05|2-Sided|95.0|0.7858|4.5073|||Mixed Models Analysis|7,24||Open-label study testing for change in side-effects ratings over time (i.e., slope).|
1717851|NCT00731120|3162271|Superiority or Other||LS Mean Difference|-0.81|Standard Error of the Mean|0.791||0.306|2-Sided|95.0|-2.36|0.74||Pre-specified sequential statistical testing procedure indicates that when p-value >0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.|||
1717852|NCT00731120|3162271|Superiority or Other||LS Mean Difference|-0.87|Standard Error of the Mean|0.803||0.279|2-Sided|95.0|-2.45|0.71||Hierarchical testing stopped at 10 mg versus placebo for HAM-A total score at Week 8 in the testing sequence, a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-A as a covariate.||P-values were tested at the 5% significance level (ie, statistical significance if P<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 2.5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.|
1717853|NCT00730756|3162337|Superiority or Other|||||||0.845|||||||ANCOVA|Center, baseline eosinophils, baseline symptom score, age, and gender were included as covariates in all efficacy analyses.|||
1717854|NCT00730691|3162352|Superiority or Other||LS Mean Difference|-4.54|Standard Error of the Mean|1.425||0.002|2-Sided|95.0|-7.34|-1.73|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717855|NCT00730691|3162352|Superiority or Other||LS Mean Difference|-1.61|Standard Error of the Mean|1.397||0.25|2-Sided|95.0|-4.36|1.14|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717856|NCT00730691|3162352|Superiority or Other||LS Mean Difference|-2.26|Standard Error of the Mean|1.353||0.096|2-Sided|95.0|-4.92|0.4|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717882|NCT00730405|3162375|Superiority or Other||Mean Difference (Net)|-3.22|Standard Error of the Mean|0.58|<|0.001|||||||ANOVA||||
1717857|NCT00730691|3162352|Superiority or Other||LS Mean Difference|-2.5|Standard Error of the Mean|1.346||0.064|2-Sided|95.0|-5.15|0.14|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717858|NCT00730691|3162353|Superiority or Other||Odds Ratio (OR)|1.427||||0.124|2-Sided|95.0|0.907|2.246|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.|||
1717859|NCT00730691|3162353|Superiority or Other||Odds Ratio (OR)|1.114||||0.641|2-Sided|95.0|0.709|1.749|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.|||
1717860|NCT00730691|3162353|Superiority or Other||Odds Ratio (OR)|1.016||||0.945|2-Sided|95.0|0.643|1.605|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.|||
1717861|NCT00730691|3162353|Superiority or Other||Odds Ratio (OR)|1.114||||0.641|2-Sided|95.0|0.709|1.75|||Regression, Logistic|Logistic regression with explanatory variables for treatment and Baseline HAM-A score.|||
1717862|NCT00730691|3162354|Superiority or Other||LS Mean Difference|-2.57|Standard Error of the Mean|0.781||0.001|2-Sided|95.0|-4.1|-1.03|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717863|NCT00730691|3162354|Superiority or Other||LS Mean Difference|-0.94|Standard Error of the Mean|0.736||0.204|2-Sided|95.0|-2.38|0.51|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717864|NCT00730691|3162354|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|0.754||0.511|2-Sided|95.0|-1.98|0.98|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717865|NCT00730691|3162354|Superiority or Other||LS Mean Difference|0.35|Standard Error of the Mean|0.765||0.652|2-Sided|95.0|-1.16|1.85|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717866|NCT00730691|3162355|Superiority or Other||LS Mean Difference|-0.44|Standard Error of the Mean|0.133||0.001|2-Sided|95.0|-0.7|-0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717867|NCT00730691|3162355|Superiority or Other||LS Mean Difference|-0.09|Standard Error of the Mean|0.13||0.491|2-Sided|95.0|-0.34|0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717868|NCT00730691|3162355|Superiority or Other||LS Mean Difference|-0.08|Standard Error of the Mean|0.129||0.533|2-Sided|95.0|-0.33|0.17|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717869|NCT00730691|3162355|Superiority or Other||LS Mean Difference|-0.11|Standard Error of the Mean|0.129||0.407|2-Sided|95.0|-0.36|0.15|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717870|NCT00730691|3162356|Superiority or Other||LS mean Difference|-1.54|Standard Error of the Mean|0.527||0.004|2-Sided|95.0|-2.58|-0.5|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717871|NCT00730691|3162356|Superiority or Other||LS Mean Difference|-1.09|Standard Error of the Mean|0.517||0.036|2-Sided|95.0|-2.1|-0.07||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717872|NCT00730691|3162356|Superiority or Other||LS Mean Difference|-0.24|Standard Error of the Mean|0.51||0.643|2-Sided|95.0|-1.24|0.77||Hierarchical testing stopped at the primary endpoint in the testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717873|NCT00730691|3162356|Superiority or Other||LS Mean Difference|0.11|Standard Error of the Mean|0.511||0.83|2-Sided|95.0|-0.89|1.11|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717874|NCT00730691|3162357|Superiority or Other||LS Mean Difference|-2.6|Standard Error of the Mean|0.869||0.003|2-Sided|95.0|-4.3|-0.89|||Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.|||
1717875|NCT00730691|3162357|Superiority or Other||LS Mean Difference|-0.39|Standard Error of the Mean|0.848||0.642|2-Sided|95.0|-2.06|1.27||Pre-specified sequential statistical testing procedure indicates that when p-value >0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.|
1717876|NCT00730691|3162357|Superiority or Other||LS Mean Difference|-0.3|Standard Error of the Mean|0.843||0.719|2-Sided|95.0|-1.96|1.35||Pre-specified sequential statistical testing procedure indicates that when p-value >0.025, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 10 mg and 5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.025, the testing procedure stopped for all subsequent endpoints.|
1717877|NCT00730691|3162357|Superiority or Other||LS Mean Difference|-0.96|Standard Error of the Mean|0.843||0.255|2-Sided|95.0|-2.62|0.69||This treatment arm is not in the pre-specified testing sequence, a nominal p-value is provided.|Mixed model for repeated measurements|P-values are from an MMRM model with week, Baseline score-by-week and treatment-by-week interaction as factors.||P-values were tested at the 5% level of significance (ie, statistical significance if P<0.05) comparing each of the 3 doses of vortioxetine to placebo.|
1717878|NCT00730405|3162374|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717883|NCT00730405|3162375|Superiority or Other||Mean Difference (Net)|-4.44|Standard Error of the Mean|0.57|<|0.001|||||||ANOVA||||
1717884|NCT00730405|3162375|Superiority or Other||Mean Difference (Net)|-5.71|Standard Error of the Mean|0.57|<|0.001|||||||ANOVA||||
1717885|NCT00730405|3162375|Superiority or Other||Mean Difference (Net)|-6.1|Standard Error of the Mean|0.57|<|0.001|||||||ANOVA||||
1717886|NCT00730405|3162376|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717887|NCT00730405|3162376|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717888|NCT00730405|3162376|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717889|NCT00730405|3162376|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717890|NCT00730405|3162377|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717891|NCT00730405|3162377|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717892|NCT00730405|3162377|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717893|NCT00730405|3162377|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717894|NCT00730405|3162378|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717895|NCT00730405|3162378|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717896|NCT00730405|3162378|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717897|NCT00730405|3162378|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717898|NCT00730405|3162379|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717899|NCT00730405|3162379|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717900|NCT00730405|3162379|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717901|NCT00730405|3162379|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1717902|NCT00730132|3162430|Superiority or Other||Mean Difference (Final Values)|-3.81773|Standard Error of the Mean|1.88425||0.107|2-Sided|95.0|-8.2523|0.6169|||Games-Howell|||New Statin compared to Ezetimibe|
1717903|NCT00730132|3162430|Superiority or Other||Mean Difference (Final Values)|-5.24911|Standard Error of the Mean|1.97821||0.023|2-Sided|95.0|-9.9072|-0.591|||Games-Howell|||Statin Dose Titration compared to Ezetimibe|
1717904|NCT00730132|3162430|Superiority or Other||Mean Difference (Final Values)|-1.43138|Standard Error of the Mean|2.01009||0.756|2-Sided|95.0|-6.1604|3.2977|||Games-Howell|||Statin Dose Titration compared to New Statin|
1717905|NCT00730132|3162430|Superiority or Other||Mean Difference (Final Values)|32.0665|Standard Deviation|15.5901||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)|
1717906|NCT00730132|3162430|Superiority or Other||Mean Difference (Final Values)|28.2488|Standard Deviation|20.78727||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)|
1717907|NCT00730132|3162430|Superiority or Other||Mean Difference (Final Values)|26.8174|Standard Deviation|19.85205||||95.0||||||||Descriptive statistics of relative (%) change in LDL-C levels by the end of the study (Visit 2) compared to Baseline (Visit 1)|
1717908|NCT00730132|3162431|Superiority or Other||Mean Difference (Final Values)|-2.93883|Standard Error of the Mean|1.38286||0.086|2-Sided|95.0|-6.1948|0.3171|||Games-Howell|||New Statin compared to Ezetimibe|
1717909|NCT00730132|3162431|Superiority or Other||Mean Difference (Final Values)|-5.74811|Standard Error of the Mean|1.56351||0.001|2-Sided|95.0|-9.4298|-2.0664|||Games-Howell|||Statin Dose Titration compared to Ezetimbe|
1717910|NCT00730132|3162431|Superiority or Other||Mean Difference (Final Values)|-2.80928|Standard Error of the Mean|1.48621||0.143|2-Sided|95.0|-6.307|0.6884|||Games-Howell|||Statin Dose Titration compared to New Statin|
1717911|NCT00730132|3162431|Superiority or Other||Mean Difference (Final Values)|22.8181|Standard Deviation|14.03545||||95.0||||||||Descriptive statistics of relative (%) change in TC from baseline at Visit 2|
1717912|NCT00730132|3162431|Superiority or Other||Mean Difference (Final Values)|20.0|Standard Deviation|15.662||||95.0||||||||Descriptive statistics of relative (%) change in TC from baseline at Visit 2|
1717913|NCT00730132|3162431|Superiority or Other||Mean Difference (Final Values)|25.757|Standard Deviation|12.30606||||95.0||||||||Descriptive statistics of relative (%) change in TC levels from Baseline at Visit 2|
1717914|NCT00730132|3162432|Superiority or Other||||||<|0.001||||||Chi square, continuity corrected. Asymptotic significance.|McNemar|||Significance of paired changes in the number of patients who achieved LDL-C target levels on Visit 2, for each treatment group comparison|
1717915|NCT00730132|3162433|Superiority or Other|||||||0.007|||||||Pearson Chi-Square|||Significance of the differences in the number of patients per group who achieved goal TC levels on Visit 2.|
1717916|NCT00730028|3162442|Superiority or Other||Mean Difference (Final Values)|-10.4||||0.0145|2-Sided|95.0|-18.7|-2.0||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.|
1717917|NCT00730028|3162442|Superiority or Other||Mean Difference (Final Values)|-15.9|||<|0.0001|2-Sided|95.0|-24.0|-7.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.|
1717918|NCT00730028|3162442|Superiority or Other||Mean Difference (Final Values)|-5.6|||<|0.1552|2-Sided|95.0|-13.2|2.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.|
1717919|NCT00730028|3162442|Superiority or Other||Mean Difference (Final Values)|-5.4|||<|0.1815|2-Sided|95.0|-13.6|2.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.|
1717920|NCT00730028|3162443|Superiority or Other||Mean Difference (Final Values)|-11.1||||0.0046|2-Sided|95.0|-19.0|-3.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.|
1717921|NCT00730028|3162443|Superiority or Other||Mean Difference (Final Values)|-15.5|||<|0.0001|2-Sided|95.0|-23.0|-8.0||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.|
1717922|NCT00730028|3162443|Superiority or Other||Mean Difference (Final Values)|-4.4|||<|0.1666|2-Sided|95.0|-10.9|2.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.|
1717923|NCT00730028|3162443|Superiority or Other||Mean Difference (Final Values)|-5.7|||<|0.1505|2-Sided|95.0|-13.3|1.9||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.|
1717924|NCT00730028|3162444|Superiority or Other||Mean Difference (Final Values)|-7.5||||0.0507|2-Sided|95.0|-15.2|0.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.|
1717925|NCT00730028|3162444|Superiority or Other||Mean Difference (Final Values)|-6.6||||0.0838|2-Sided|95.0|-14.3|1.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.|
1717926|NCT00730028|3162444|Superiority or Other||Mean Difference (Final Values)|0.9||||0.8302|2-Sided|95.0|-6.4|8.2||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.|
1717927|NCT00730028|3162444|Superiority or Other||Mean Difference (Final Values)|-5.7||||0.1381|2-Sided|95.0|-13.1|1.8||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.|
1717928|NCT00730028|3162445|Superiority or Other||Mean Difference (Final Values)|-9.2||||0.0017|2-Sided|95.0|-15.3|-3.1||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.|
1717929|NCT00730028|3162445|Superiority or Other||Mean Difference (Final Values)|-6.0||||0.0593|2-Sided|95.0|-12.4|0.5||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.|
1717930|NCT00730028|3162445|Superiority or Other||Mean Difference (Final Values)|3.3||||0.2141|2-Sided|95.0|-2.0|8.5||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess.|
1717931|NCT00730028|3162445|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.7707|2-Sided|95.0|-7.1|5.3||Adjustments for multiple comparisons were not made for secondary efficacy outcome measures.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess.|
1717932|NCT00730028|3162446|Superiority or Other||Mean Difference (Final Values)|-12.9||||0.0008|2-Sided|95.0|-20.8|-5.0||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.|
1717933|NCT00730028|3162446|Superiority or Other||Mean Difference (Final Values)|-14.2||||0.0001|2-Sided|95.0|-22.0|-6.4||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.|
1717934|NCT00730028|3162446|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.7324|2-Sided|95.0|-8.4|5.7||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.|
1717935|NCT00730028|3162446|Superiority or Other||Mean Difference (Final Values)|-2.6||||0.52|2-Sided|95.0|-10.2|4.9||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.|
1717964|NCT00729326|3162685|Superiority or Other|||||||0.117|||||||ANCOVA||||
1717936|NCT00730028|3162449|Superiority or Other||Mean Difference (Final Values)|-12.2||||0.0002|2-Sided|95.0|-19.1|-5.4||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus TMP-SMX.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.|
1717937|NCT00730028|3162449|Superiority or Other||Mean Difference (Final Values)|-12.4|||<|0.0001|2-Sided|95.0|-19.2|-5.6||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of Placebo minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.|
1717938|NCT00730028|3162449|Superiority or Other||Mean Difference (Final Values)|-0.2|||<|1|2-Sided|95.0|-5.4|5.1||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: After successful surgical drainage, placebo, Clindamycin, and TMP-SMX have equal rates of cure in the treatment of limited abscess at the TOC visit.|
1717939|NCT00730028|3162449|Superiority or Other||Mean Difference (Final Values)|-1.2|||<|0.7688|2-Sided|95.0|-7.6|5.1||Adjustments for multiple comparisons were made using a Bonferroni correction.|Fisher Exact||The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.|Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.|
1717940|NCT00730015|3162457|Superiority or Other||Odds Ratio (OR)|7.21|||<|0.0001|2-Sided|95.0|3.14|16.59||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 290-μg dose and those taking placebo. The power, adjusted for multiplicity, was expected to be greater than 96% based on study NCT00402337(MCP-103-201) data.|
1717941|NCT00730015|3162457|Superiority or Other||Odds Ratio (OR)|7.72|||<|0.0001|2-Sided|95.0|3.41|17.47||The p-value is still less than 0.05 after adjusting multiplicity using a serial gatekeeping multiple comparison procedure.|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference in the proportion of 12-week CSBM overall responders between patients taking the 145-μg dose and those taking placebo. The power, adjusted for multiplicity, was expected to be at least 90% based on study NCT00402337(MCP-103-201) data.|
1717942|NCT00729924|3162489|Superiority or Other|||||||0.43||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||We explored post-hoc whether the ratio of the 4-hour CSF concentration value to the 2-hour plasma concentration differs between participants with ABCB1 C/C and T/T genotypes.|
1717943|NCT00729924|3162490|Superiority or Other|||||||0.43||||||The p-value is not adjusted for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The hypothesis was that the ratio of the 4-hour CSF concentration value to the partial plasma area-under-the-curve 0-4h value would differ between participants with ABCB1 C/C and T/T genotypes.|
1717944|NCT00729859|3162500|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Deviation|0.0075||0.28|2-Sided|95.0|0.005|0.035|||paired t-test|||p value for the difference = 0.28|
1717945|NCT00729781|3162525|Superiority or Other||Percent of subjects with improvement|15.6|||>|0.99|1-Sided|97.5|0.05||||One-sided, binomial exact test||||
1717946|NCT00729781|3162526|Superiority or Other||Percent of subjects with improvement|57.8||||0.19|1-Sided|97.5|42.2||||One-sided, binomial exact test|||This study had two independent primary endpoints (cosmetic and functional improvement). Therefore, the assumed type I error rate for each was 2.5% in order to maintain an overall 5% type I error rate. For each endpoint, the percent of subjects with improvement of the total number implanted was to be compared to a rate of 50% using a one-sided, binomial exact test. If the p-value was < 0.025, the objective would have been met.|
1717947|NCT00729690|3162527|Superiority or Other|||||||0.9361|||||||ANOVA||||
1717948|NCT00729690|3162528|Superiority or Other|||||||0.4321|||||||ANOVA||||
1717949|NCT00729690|3162529|Superiority or Other|||||||0.7596|||||||ANOVA||||
1717950|NCT00729690|3162530|Superiority or Other|||||||0.4742|||||||ANOVA|||For 1st 24 hours NRS AUC Pain scores|
1717951|NCT00729677|3162534|Superiority or Other|||||||0.05|||||||ANOVA||||
1717952|NCT00729651|3162536|Superiority or Other||Odds Ratio (OR)|0.02|||<|0.0001||95.0|0.01|0.04|||Cochran-Mantel-Haenszel|It was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.|Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects’ proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.||
1717953|NCT00729651|3162537|Superiority or Other|||||||0.0091|||||||ANCOVA|Least squares mean is mean of serum PTH percentage changes adjusted serum PTH level at baseline.|||
1717954|NCT00729651|3162538|Superiority or Other||Odds Ratio (OR)|0.02|||<|0.0001||95.0|0.0|0.08|||Cochran-Mantel-Haenszel|Primary efficacy endpoint was analyzed by a Cochran-Mantel-Haenszel test with baseline vitamin D level as covariate.|Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects’ proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.||
1717955|NCT00729521|3162549|Superiority or Other||Incident Rate Ratio|0.91|Standard Deviation|1.0|<|0.05|2-Sided|95.0|0.88|0.94|||Mixed Models Analysis|Mixed Effected Poisson Model Regression|Comparison group is the control arm.||
1717956|NCT00729521|3162549|Superiority or Other||Incidence Rate Ratio|0.92|Standard Deviation|1.0|<|0.05|2-Sided|95.0|0.88|0.95|||Mixed Models Analysis|Mixed Effects Poisson Regression|Comparison group is the control arm.||
1717957|NCT00729326|3162678|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1717958|NCT00729326|3162679|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1717959|NCT00729326|3162680|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1717960|NCT00729326|3162681|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1717961|NCT00729326|3162682|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1717962|NCT00729326|3162683|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1717963|NCT00729326|3162684|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1717969|NCT00729326|3162690|Superiority or Other||||||<|0.001||||||The p-values were not adjusted. The primary measure was change in 24-hour glucose without multiplicity adjustments for other analyses.|ANCOVA|Analyses for continuous variables adjusted for treatment, period, sequence, baseline of the continuous variable.Analysis method was Grizzle's model.||Null hypothesis: The 24-hour average glucose for exenatide was greater than or equal to that for sitagliptin after 4 weeks of treatment. The primary objective was to compare exenatide with sitagliptin on the time-averaged glucose during the 24-hour inpatient periods after 4 weeks of treatment.|
1717970|NCT00729183|3162692|Superiority or Other||Difference in LS Means|-9.07||||0.225|2-Sided|95.0|-23.69|5.56|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-P1NP (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline [Randomization], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo.|
1717971|NCT00729183|3162692|Superiority or Other||Difference in LS Means|-25.34|||<|0.001|2-Sided|95.0|-37.77|-12.92|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-P1NP (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline [Randomization], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo.|
1717972|NCT00729183|3162693|Superiority or Other||Difference in LS Means|-45.59|||<|0.001|2-Sided|95.0|-62.22|-28.96|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-CTx (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline [Randomization], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo|
1717973|NCT00729183|3162693|Superiority or Other||Difference in LS Means|-54.03|||<|0.001|2-Sided|95.0|-64.81|-43.26|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain geometric LS mean percent change from BL in s-CTx (back-transformation of the log-transformed fraction from BL) and its 95% CI. The model, applied on all time points during treatment (Baseline [Randomization], Month 6, Month 12, Month 18, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo|
1717974|NCT00729183|3162694|Superiority or Other||Difference in LS Means|9.38|||<|0.001|2-Sided|95.0|6.98|11.77|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo|
1717975|NCT00729183|3162694|Superiority or Other||Difference in LS Means|5.68|||<|0.001|2-Sided|95.0|3.77|7.58|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo|
1717976|NCT00729183|3162695|Superiority or Other||Difference in LS Means|11.46|||<|0.001|2-Sided|95.0|8.96|13.97|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo|
1717977|NCT00729183|3162695|Superiority or Other||Difference in LS Means|8.01|||<|0.001|2-Sided|95.0|6.03|9.99|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo|
1717978|NCT00729183|3162696|Superiority or Other||Difference in LS Means|1.22||||0.013|2-Sided|95.0|0.27|2.18|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo|
1717979|NCT00729183|3162696|Superiority or Other||Difference in LS Means|0.16||||0.697|2-Sided|95.0|-0.63|0.95|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo|
1717980|NCT00729183|3162697|Superiority or Other||Difference in LS Means|2.7|||<|0.001|2-Sided|95.0|1.62|3.78|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo|
1717981|NCT00729183|3162697|Superiority or Other||Difference in LS Means|1.71|||<|0.001|2-Sided|95.0|0.69|2.73|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo|
1717982|NCT00729183|3162698|Superiority or Other||Difference in LS Means|1.7|||<|0.001|2-Sided|95.0|0.97|2.43|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo|
1717983|NCT00729183|3162698|Superiority or Other||Difference in LS Means|0.71|||<|0.03|2-Sided|95.0|0.07|1.35|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo|
1717984|NCT00729183|3162699|Superiority or Other||Difference in LS Means|5.48|||<|0.001|2-Sided|95.0|4.08|6.89|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo|
1717985|NCT00729183|3162699|Superiority or Other||Difference in LS Means|2.19|||<|0.001|2-Sided|95.0|1.09|3.29|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo|
1717986|NCT00729183|3162700|Superiority or Other||Difference in LS Means|3.81|||<|0.001|2-Sided|95.0|2.69|4.93|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo|
1717987|NCT00729183|3162700|Superiority or Other||Difference in LS Means|1.48|||<|0.001|2-Sided|95.0|0.6|2.35|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo|
1717988|NCT00729183|3162701|Superiority or Other||Difference in LS Means|3.32|||<|0.001|2-Sided|95.0|2.39|4.26|||LDA|||MONTH 24: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 24 = Odancatib 50 mg minus Placebo|
1717989|NCT00729183|3162701|Superiority or Other||Difference in LS Means|1.57|||<|0.001|2-Sided|95.0|0.88|2.25|||LDA|||MONTH 12: A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and baseline value as covariate. The weighted LS mean is based on the described model. Difference in LS Means at Month 12 = Odancatib 50 mg minus Placebo|
1717990|NCT00729183|3162702|Superiority or Other||Difference in LS Means|5.39|||<|0.001|2-Sided|95.0|4.36|6.42|||LDA|||A longitudinal ANCOVA model was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% CI. The model, applied on all time points during treatment (Screening Visit [Baseline], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. The weighted LS mean is based on the described model. Difference in LS Means = Odancatib 50 mg minus Placebo.|
1717991|NCT00729183|3162703|Superiority or Other||Difference in Percentage|4.4|||||2-Sided|95.0|-3.2|12.3||||||Estimated difference (versus Placebo) and CI were based on the Miettinen & Nurminen method.|
1717992|NCT00729183|3162704|Superiority or Other||Difference in Percentage|-2.2|||||2-Sided|95.0|-12.3|7.9||||||Estimated difference (versus Placebo) and CI were based on the Miettinen & Nurminen method.|
1717993|NCT00729183|3162705|Superiority or Other||Difference in LS Means|3.49|||<|0.001|2-Sided|95.0|2.66|4.32|||Longitudinal Data Analysis (LDA) Model|||A longitudinal ANCOVA was used to obtain an estimate of the between-treatment difference in aBMD together with its 95% confidence interval (CI). The model, applied on all time points during treatment (Screening Visit [BL], Month 6, Month 12, Month 24), included treatment, region, time and interaction between treatment and time as fixed effects, and BL value as covariate. The weighted Least Squares (LS) mean is based on the described model. Difference in LS Means = Odancatib 50 mg minus Placebo.|
1717994|NCT00728988|3162718|Superiority or Other||Mean Difference (Final Values)|-58.22||||0.4741|2-Sided|95.0|-218.12|101.68|||ANOVA|||30 days post-PCI: difference (% change).|
1717995|NCT00728988|3162718|Superiority or Other||Mean Difference (Final Values)|50.58||||0.7436|2-Sided|95.0|-253.42|354.58|||ANOVA|||24 hours post-PCI: difference (% change).|
1717996|NCT00728988|3162718|Superiority or Other||Mean Difference (Final Values)|-29.53||||0.7554|2-Sided|95.0|-215.87|156.81|||ANOVA|||8 hours post-PCI: difference (% change).|
1717997|NCT00728988|3162719|Superiority or Other||Mean Difference (Final Values)|0.7||||0.616|2-Sided|95.0|-10.3|11.5|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.|
1717998|NCT00728988|3162719|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.827|2-Sided|95.0|-5.8|3.6|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.|
1717999|NCT00728988|3162719|Superiority or Other||Mean Difference (Final Values)|-2.7||||0.529|2-Sided|95.0|-9.6|4.3|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.|
1718000|NCT00728988|3162720|Superiority or Other||Mean Difference (Final Values)|0.1||||1|2-Sided|95.0|-10.7|10.9|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.|
1718001|NCT00728988|3162720|Superiority or Other||Mean Difference (Final Values)|5.3||||0.392|2-Sided|95.0|-6.1|16.7|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.|
1718002|NCT00728988|3162720|Superiority or Other||Mean Difference (Final Values)|4.9||||0.425|2-Sided|95.0|-6.2|15.9|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.|
1718003|NCT00728988|3162721|Superiority or Other||Mean Difference (Final Values)|1.3||||0.236|2-Sided|95.0|-9.6|12.0|||Fisher Exact|||30 days post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. Fisher's exact test was applied because the expected frequency of biomarker elevation was less than 5.|
1718004|NCT00728988|3162721|Superiority or Other||Mean Difference (Final Values)|-3.3||||0.518|2-Sided|95.0|-12.1|5.5|||Chi-squared, Corrected|||24 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.|
1718005|NCT00728988|3162721|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.631|2-Sided|95.0|-10.1|5.4|||Chi-squared, Corrected|||8 hours post-PCI: difference (%) in proportions. Null hypothesis = no difference in proportions of the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.|
1718006|NCT00728988|3162722|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.7896|2-Sided|95.0|-9.7|6.5|||Chi-squared, Corrected||Difference of incidence = atorvastatin minus usual care .|Treatment difference (%). Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.|
1718007|NCT00728988|3162723|Superiority or Other||Mean Difference (Final Values)|0.4||||1|2-Sided|95.0|-5.6|6.3|||Chi-squared, Corrected||Difference of incidence = atorvastatin minus usual care.|Treatment difference (%). Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.|
1718008|NCT00728988|3162724|Superiority or Other|||||||0.8494|||||||Log Rank|Survival analysis: Kaplan-Meier log rank test.||MACE-free survival up to Day 30. A censoring variable with a value of 1 denoted that the subject had the event and 0 indicated that the subject was censored. A log-rank test was applied to investigate any differences on the survival distribution function between two treatment groups.|
1718009|NCT00728988|3162724|Superiority or Other||Odds Ratio (OR)|0.96||||0.9|2-Sided|95.0|0.4887|1.8836|||Regression, Logistic|||Adjusted odds ratio: model includes treatment group and potential confounding covariates age, gender, country, non-ST elevation myocardial infarction, LVEF <=40, and use of beta-blockers, ACE-inhibitors, angiotension receptor blockers, calcium channel antagonists, and diuretics. Reference group = usual care.|
1718010|NCT00728988|3162724|Superiority or Other||Odds Ratio (OR)|0.93||||0.8|2-Sided|95.0|0.5104|1.6846|||Regression, Logistic|||Unadjusted odds ratio and 95% confidence interval calculated by including treatment group as the only covariate in the logistic regression model. Reference group = usual care.|
1718011|NCT00728988|3162724|Superiority or Other||Mean Difference (Final Values)|1.0||||0.9158|2-Sided|95.0|-7.2|9.2|||Chi-squared, Corrected||Difference of incidence = usual care minus atorvastatin.|Myocardial Infarction: treatment difference. Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.|
1718012|NCT00728988|3162724|Superiority or Other||Mean Difference (Final Values)|0.0||||1|2-Sided|95.0|-10.7|10.7|||Fisher Exact||Confidence limits were calculated by the exact unconditional inference. Difference of incidence = usual care minus atorvastatin.|Death: treatment difference. Null hypothesis = no difference between the incidence rates in two groups. Fisher’s exact test was applied because the expected frequency of events was less than 5.|
1718013|NCT00728988|3162724|Superiority or Other||Mean Difference (Final Values)|1.0||||0.9237|2-Sided|95.0|-7.3|9.3|||Chi-squared, Corrected||95% confidence interval for the true difference in the incidence of MACE between the two treatment groups. Difference of incidence = usual care minus atorvastatin.|Total MACE: treatment difference. Null hypothesis = no difference between the incidence rates in the two groups. A 5% two-sided continuity adjusted Chi-square test was applied.|
1718014|NCT00728910|3162737|Superiority or Other||||||<|0.0005|||||||Mixed Models Analysis||||
1718015|NCT00728910|3162737|Superiority or Other||||||<|0.0005|||||||Mixed Models Analysis|||Null hypothesis was that sequential addition of fibrate and niacin to baseline atorvastatin therapy would have no effect on post-prandial triglyceride levels following an oral fat load|
1718016|NCT00728910|3162738|Superiority or Other||||||>|0.5|||||||Mixed Models Analysis|||The null hypothesis was that sequential addition of fibrate and niacin to baseline atorvastatin therapy would have no effect on apo-A1 production rates|
1718017|NCT00728910|3162739|Superiority or Other||||||>|0.5|||||||Mixed Models Analysis|||Null hypothesis was that the sequential addition of a fibrate and niacin to baseline atorvastatin therapy would not have any effect on apo-AI catabolism.|
1718018|NCT00728689|3162759|Superiority or Other|||||||0.8581|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. A parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms.|
1718019|NCT00728689|3162760|Superiority or Other|||||||0.0422|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, Cmax was analyzed on a log scale, to assess bioequivalence between Form I and Form V.|
1718020|NCT00728689|3162761|Superiority or Other|||||||0.0997|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, AUC0-∞ was analyzed on a log scale, to assess bioequivalence between Form I and Form V.|
1718021|NCT00728689|3162762|Superiority or Other|||||||0.0048|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. Firstly, a parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms. Secondly, AUC0-τ was analyzed on a log scale, to assess bioequivalence between Form I and Form V.|
1718022|NCT00728689|3162763|Superiority or Other|||||||0.4591|||||||ANOVA|||A sample size of 12 subjects was chosen to provide a statistical power of 80% to detect a 25% difference of the Form V mean between the Form I and Form V doses at the 0.05 level (2-sided) for this crossover design. A parametric (normal theory) general linear model was applied and an ANOVA for a 2-way crossover design was employed to examine the differences among the 2 forms.|
1718023|NCT00728481|3162773|Superiority or Other|||||||0.76|||||||Fisher Exact|||Comparison between arms for a symptomatic response|
1718024|NCT00728481|3162778|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison between arms for a histologic response|
1718025|NCT00728416|3162798|Superiority or Other||Difference in LS Means|-1.27|||<|0.001|2-Sided|95.0|-1.72|-0.83|||ANCOVA|||The change from Baseline in average AM/PM PRIOR TNSS over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM TNSS as covariates.|
1718026|NCT00728416|3162799|Superiority or Other||Difference in LS Means|-0.31|||<|0.001|2-Sided|95.0|-0.43|-0.19|||ANCOVA|||The change from Baseline in average AM/PM PRIOR nasal congestion score over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM PRIOR Nasal Congestion Score as covariates.|
1718027|NCT00728182|3162803|Superiority or Other||Relative Risk|1.3||||0.18|2-Sided|95.0|0.95|1.7|||Chi-squared||||
1718028|NCT00728182|3162804|Superiority or Other||Relative Risk|1.5||||0.02|2-Sided|95.0|1.1|2.0|||Chi-squared||||
1718029|NCT00728182|3162805|Superiority or Other|||||||0.015|||||||ANCOVA||||
1718030|NCT00728182|3162806|Superiority or Other||Adjusted Incidence Rate Ratio|0.36||||0.046|2-Sided|95.0|0.17|0.75|||Generalized linear model||||
1718031|NCT00728182|3162807|Superiority or Other||Adjusted Incidence Rate Ratio|0.36||||0.027|2-Sided|95.0|0.17|0.73|||Adjusted Incidence Rate Ratio||||
1718032|NCT00728182|3162808|Superiority or Other|||||||0.023|||||||ANCOVA||||
1718033|NCT00728182|3162809|Superiority or Other||Relative Risk|1.0||||1|2-Sided|95.0|0.9|1.1|||Chi-squared|||Comparison of the number of patients with mRS scores of 0-2 at Day 30 for NA-1 and placebo treated groups.|
1718034|NCT00728182|3162810|Superiority or Other||Relative Risk|1.0||||0.43|2-Sided|95.0|0.9|1.1|||Chi-squared|||Number of patients obtaining a score on the NIHSS of 0-1 at Day 30.|
1718035|NCT00728182|3162811|Superiority or Other|||||||0.306|||||||ANCOVA|Data were cubic root transformed and modelled with multiple linear regresion.||Comparison of the summed volume of new ischemic lesions on DWI.|
1718036|NCT00728182|3162812|Superiority or Other||Adjusted Incidence Rate Ratio|0.59||||0.048|2-Sided|95.0|0.42|0.83|||Generalized linear model|With log link and negative binomial distribution.||Comparison of the total number of new FLAIR lesions in the NA-1 versus placebo treated groups.|
1718037|NCT00728182|3162813|Superiority or Other||Adjusted Incidence Rate Ratio|0.53||||0.018|2-Sided|95.0|0.38|0.74|||Generalized linear model|With log link and negative bnomial distribution.||Comparison of the total number of new ischemic lesions on DWI for NA-1 versus placebo treated groups.|
1718038|NCT00728182|3162814|Superiority or Other|||||||0.445|||||||ANCOVA|Data were cubic root transformed and modelled with multiple linear regression.||Comparison of the summed volume of new FLAIR lesions in the NA-1 and placebo treated groups.|
1718039|NCT00727857|3162825|Superiority or Other||Mean Difference (Final Values)|-8.76|||<|0.0001||95.0|-12.36|-5.16|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718040|NCT00727857|3162825|Superiority or Other||Mean Difference (Final Values)|-5.9|||<|0.0009||95.0|-9.36|-2.44|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718041|NCT00727857|3162825|Superiority or Other||Mean Difference (Final Values)|2.86|||<|0.1217||95.0|-0.76|6.48|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718131|NCT00727506|3162917|Superiority or Other|||||||0.008||||||P-value is an approximate normal test for the six month time point.|z-test||||
1718042|NCT00727857|3162826|Superiority or Other||Mean Difference (Final Values)|-3.47||||0.1001||95.0|-7.61|0.67|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718043|NCT00727857|3162826|Superiority or Other||Mean Difference (Final Values)|-2.41||||0.2346||95.0|-6.38|1.57|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718044|NCT00727857|3162826|Superiority or Other||Mean Difference (Final Values)|1.06||||0.615||95.0|-3.09|5.21|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718045|NCT00727857|3162827|Superiority or Other||Mean Difference (Final Values)|0.02||||0.974||95.0|-0.99|1.03|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718046|NCT00727857|3162827|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.6169||95.0|-1.22|0.72|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718047|NCT00727857|3162827|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.609||95.0|-1.28|0.75|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718048|NCT00727857|3162828|Superiority or Other||Mean Difference (Final Values)|3.59|||<|0.0001||95.0|1.81|5.36|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718049|NCT00727857|3162828|Superiority or Other||Mean Difference (Final Values)|2.44|||<|0.0052||95.0|0.73|4.15|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718050|NCT00727857|3162828|Superiority or Other||Mean Difference (Final Values)|-1.15|||<|0.2069||95.0|-2.93|0.64|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718051|NCT00727857|3162829|Superiority or Other||Mean Difference (Final Values)|-12.29||||0.0002||95.0|-18.65|-5.93|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718052|NCT00727857|3162829|Superiority or Other||Mean Difference (Final Values)|-8.52||||0.0063||95.0|-14.63|-2.42|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718053|NCT00727857|3162829|Superiority or Other||Mean Difference (Final Values)|3.76||||0.2466||95.0|-2.61|10.14|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718054|NCT00727857|3162830|Superiority or Other||Mean Difference (Final Values)|3.6|||<|0.0001||95.0|2.59|4.61|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718055|NCT00727857|3162830|Superiority or Other||Mean Difference (Final Values)|1.97|||<|0.0001||95.0|1.01|2.94|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718056|NCT00727857|3162830|Superiority or Other||Mean Difference (Final Values)|-1.63|||<|0.0017||95.0|-2.64|-0.62|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718057|NCT00727857|3162831|Superiority or Other||Mean Difference (Final Values)|-1.71|||<|0.0001||95.0|-2.53|-0.89|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718058|NCT00727857|3162831|Superiority or Other||Mean Difference (Final Values)|-1.43|||<|0.0004||95.0|-2.22|-0.64|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718059|NCT00727857|3162831|Superiority or Other||Mean Difference (Final Values)|0.28|||<|0.5044||95.0|-0.54|1.1|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718060|NCT00727857|3162832|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.0593||95.0|-1.02|0.02|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718061|NCT00727857|3162832|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.4617||95.0|-0.69|0.31|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718062|NCT00727857|3162832|Superiority or Other||Mean Difference (Final Values)|0.31||||0.2384||95.0|-0.21|0.83|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718063|NCT00727857|3162833|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.0076||95.0|-0.14|-0.02|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718344|NCT00721799|3163760|Other||Hazard Ratio (HR)|0.83||||0.63|2-Sided||||||Regression, Cox||||
1718064|NCT00727857|3162833|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.1487||95.0|-0.1|0.02|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718065|NCT00727857|3162833|Superiority or Other||Mean Difference (Final Values)|0.04||||0.1986||95.0|-0.02|0.1|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718066|NCT00727857|3162834|Superiority or Other||Mean Difference (Final Values)|1.42||||0.0004||95.0|0.64|2.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718067|NCT00727857|3162834|Superiority or Other||Mean Difference (Final Values)|0.34||||0.3682||95.0|-0.41|1.1|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718068|NCT00727857|3162834|Superiority or Other||Mean Difference (Final Values)|-1.08||||0.0072||95.0|-1.86|-0.29|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718069|NCT00727857|3162835|Superiority or Other||Mean Difference (Final Values)|111.4||||0.0008||95.0|46.8|175.9|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718070|NCT00727857|3162835|Superiority or Other||Mean Difference (Final Values)|111.7||||0.0004||95.0|49.7|173.7|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718071|NCT00727857|3162835|Superiority or Other||Mean Difference (Final Values)|0.3||||0.9922||95.0|-64.4|65.1|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718072|NCT00727857|3162836|Superiority or Other||Mean Difference (Final Values)|142.3||||0.0006||95.0|61.3|223.3|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718073|NCT00727857|3162836|Superiority or Other||Mean Difference (Final Values)|140.3||||0.0004||95.0|62.5|218.0|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718074|NCT00727857|3162836|Superiority or Other||Mean Difference (Final Values)|-2.1||||0.9604||95.0|-83.3|79.2|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718075|NCT00727857|3162837|Superiority or Other||Mean Difference (Final Values)|30.6||||0.0005||95.0|13.4|47.8|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718076|NCT00727857|3162837|Superiority or Other||Mean Difference (Final Values)|28.5||||0.0008||95.0|12.0|45.0|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718077|NCT00727857|3162837|Superiority or Other||Mean Difference (Final Values)|-2.2||||0.804||95.0|-19.4|15.0|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718078|NCT00727857|3162838|Superiority or Other||Mean Difference (Final Values)|-6.2||||0.2124||95.0|-16.0|3.6|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718079|NCT00727857|3162838|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.8463||95.0|-10.3|8.5|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718080|NCT00727857|3162838|Superiority or Other||Mean Difference (Final Values)|5.3||||0.2894||95.0|-4.5|15.1|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718081|NCT00727857|3162839|Superiority or Other||Mean Difference (Final Values)|-97.3|||<|0.0001||95.0|-133.4|-61.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718082|NCT00727857|3162839|Superiority or Other||Mean Difference (Final Values)|-77.6|||<|0.0001||95.0|-112.4|-42.8|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718083|NCT00727857|3162839|Superiority or Other||Mean Difference (Final Values)|19.7|||<|0.2849||95.0|-16.5|55.9|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718084|NCT00727857|3162840|Superiority or Other||Mean Difference (Final Values)|-0.39|||<|0.0001||95.0|-0.53|-0.25|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718085|NCT00727857|3162840|Superiority or Other||Mean Difference (Final Values)|-0.34|||<|0.0001||95.0|-0.48|-0.21|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718086|NCT00727857|3162840|Superiority or Other||Mean Difference (Final Values)|0.05|||<|0.5023||95.0|-0.09|0.19|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718087|NCT00727857|3162841|Superiority or Other||Mean Difference (Final Values)|40.9||||0.2369||95.0|-26.9|108.7|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718088|NCT00727857|3162841|Superiority or Other||Mean Difference (Final Values)|64.2||||0.0531||95.0|-0.9|129.3|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718089|NCT00727857|3162841|Superiority or Other||Mean Difference (Final Values)|23.4||||0.4999||95.0|-44.6|91.4|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with a term for treatment and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718090|NCT00727857|3162842|Superiority or Other||Mean Difference (Final Values)|3.75||||0.3753||95.0|-4.56|12.07|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718091|NCT00727857|3162842|Superiority or Other||Mean Difference (Final Values)|4.16||||0.3082||95.0|-3.86|12.19|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718092|NCT00727857|3162842|Superiority or Other||Mean Difference (Final Values)|0.41||||0.9231||95.0|-7.94|8.76|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718093|NCT00727857|3162843|Superiority or Other||Mean Difference (Final Values)|-3.79||||0.728||95.0|-7.93|0.35|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718094|NCT00727857|3162843|Superiority or Other||Mean Difference (Final Values)|-8.1|||<|0.0001||95.0|-12.08|-4.12|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718095|NCT00727857|3162843|Superiority or Other||Mean Difference (Final Values)|-4.31|||<|0.0423||95.0|-8.48|-0.15|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718096|NCT00727857|3162844|Superiority or Other||Mean Difference (Final Values)|-7.46||||0.0119||95.0|-13.26|-1.66|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718097|NCT00727857|3162844|Superiority or Other||Mean Difference (Final Values)|-2.56||||0.367||95.0|-8.14|3.01|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718098|NCT00727857|3162844|Superiority or Other||Mean Difference (Final Values)|4.9||||0.0993||95.0|-0.93|10.72|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718099|NCT00727857|3162845|Superiority or Other||Mean Difference (Final Values)|-7.51|||<|0.0001||95.0|-10.9|-4.12|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718100|NCT00727857|3162845|Superiority or Other||Mean Difference (Final Values)|-3.78|||<|0.0233||95.0|-7.05|-0.52|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718101|NCT00727857|3162845|Superiority or Other||Mean Difference (Final Values)|3.73|||<|0.0324||95.0|0.31|7.14|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718102|NCT00727857|3162846|Superiority or Other||Mean Difference (Final Values)|-9.5|||<|0.0001||95.0|-11.1|-7.9|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718103|NCT00727857|3162846|Superiority or Other||Mean Difference (Final Values)|-8.1|||<|0.0001||95.0|-9.6|-6.5|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718104|NCT00727857|3162846|Superiority or Other||Mean Difference (Final Values)|1.4|||<|0.0806||95.0|-0.2|3.1|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718105|NCT00727857|3162847|Superiority or Other||Median Difference (Final Values)|8.33||||0.1053||95.0|-1.77|18.07|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.|
1718106|NCT00727857|3162847|Superiority or Other||Median Difference (Final Values)|12.81||||0.0265||95.0|2.88|22.24|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.|
1718132|NCT00727506|3162917|Superiority or Other|||||||0.148||||||P-value is from an approximate normal test for the 6 month time point.|z-test||||
1718107|NCT00727857|3162847|Superiority or Other||Median Difference (Final Values)|4.88||||0.5963||95.0|-4.71|13.97|||ANCOVA||The estimate of the median percent change from baseline and 95% confidence intervals were based on the Hodges-Lehmann method and the distribution-free confidence interval.|Nonparametric ANCOVA based on Tukey's normal rank transformation with a term for treatment and the baseline value as a covariate.|
1718108|NCT00727857|3162848|Superiority or Other||Mean Difference (Final Values)|0.989||||0.1094||95.0|-0.223|2.201|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718109|NCT00727857|3162848|Superiority or Other||Mean Difference (Final Values)|1.619||||0.0067||95.0|0.452|2.785|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718110|NCT00727857|3162848|Superiority or Other||Mean Difference (Final Values)|0.629||||0.3158||95.0|-0.602|1.861|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718111|NCT00727857|3162849|Superiority or Other||Mean Difference (Final Values)|2.2||||0.0435||95.0|0.06|4.33|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718112|NCT00727857|3162849|Superiority or Other||Mean Difference (Final Values)|2.93||||0.0047||95.0|0.9|4.95|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718113|NCT00727857|3162849|Superiority or Other||Mean Difference (Final Values)|0.73||||0.5074||95.0|-1.43|2.88|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718114|NCT00727857|3162850|Superiority or Other||Mean Difference (Final Values)|-2.6||||0.5981||95.0|-12.5|7.2|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718115|NCT00727857|3162850|Superiority or Other||Mean Difference (Final Values)|15.1||||0.0021||95.0|5.5|24.7|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718116|NCT00727857|3162850|Superiority or Other||Mean Difference (Final Values)|17.8||||0.0005||95.0|7.8|27.7|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718117|NCT00727857|3162851|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.8919||95.0|-0.37|0.33|||ANCOVA||Mean Difference = Pioglitazone - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718118|NCT00727857|3162851|Superiority or Other||Mean Difference (Final Values)|0.84|||<|0.0001||95.0|0.5|1.18|||ANCOVA||Mean Difference = Pioglitazone & metformin - metformin|One-way ANCOVA with treatment as a factor and the baseline value as a covariate. LS mean change and LS mean of the treatment difference reported.|
1718119|NCT00727857|3162851|Superiority or Other||Mean Difference (Final Values)|0.86|||<|0.0001||95.0|0.51|1.22|||ANCOVA||Mean Difference = Pioglitazone & metformin - pioglitazone|One-way Analysis of Covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.|
1718120|NCT00727558|3162878|Superiority or Other||Mean Difference (Final Values)|-0.2469|Standard Error of the Mean|0.04448||||97.47|-0.2469|-0.1599|||||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A by having a lower level of inferior region corneal staining|
1718121|NCT00727558|3162879|Superiority or Other||Mean Difference (Final Values)|0.132|Standard Error of the Mean|0.1648||||98.7|-0.2375|0.132|||||Mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A|
1718122|NCT00727558|3162880|Superiority or Other||Mean Difference (Final Values)|0.6735|Standard Error of the Mean|0.1563||||98.7|0.213|0.6735|||||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A|
1718123|NCT00727558|3162881|Superiority or Other||Mean Difference (Final Values)|0.3875|Standard Error of the Mean|0.2054||||98.7|0.03714|0.3875|||||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A.|
1718124|NCT00727558|3162882|Superiority or Other||Median Difference (Final Values)|0.3968|Standard Error of the Mean|0.1548||||98.7|0.04983|0.3968|||||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A|
1718125|NCT00727558|3162883|Superiority or Other||Mean Difference (Final Values)|-0.1734|Standard Error of the Mean|0.03555||||97.47|-0.1734|-0.1037|||||Mean difference is narafilcon A minus nelfilcon A|Alternative hypothesis: narafilcon A is superior to nelfilcon A.|
1718126|NCT00727558|3162884|Superiority or Other||Mean Difference (Final Values)|0.554|Standard Error of the Mean|0.1943||||97.47|0.1721|0.554|||||The mean difference is narafilcon A minus nelfilcon A.|Alternative hypothesis: narafilcon A is superior to nelfilcon A|
1718127|NCT00727506|3162914|Superiority or Other||Cox Proportional Hazard|1.392||||0.2044|2-Sided|95.0|0.841|2.301|||Log Rank|||Hazard ratio was calculated from Cox proportional hazard model stratified by age class (<=50 vs. >50 years old) and baseline KPS score (70, 80 vs. 90, 100). P-value was two-sided from log-rank test stratified by the same variables.|
1718128|NCT00727506|3162914|Superiority or Other||Cox Proportional Hazard|1.78||||0.032|2-Sided|95.0|1.088|2.912|||Log Rank|||Hazard ratio was calculated from Cox proportional hazard model stratified by age class (<=50 vs. >50 years old) and baseline Karnofsky Performance Scale (KPS) score (70, 80 vs. 90, 100). P-value was two-sided from log-rank test stratified by the same variables.|
1718129|NCT00727506|3162915|Superiority or Other|||||||0.1954|||||||Fisher Exact||||
1718130|NCT00727506|3162915|Superiority or Other|||||||1|||||||Fisher Exact||||
1718133|NCT00727246|3162945|Other|||||||0.329|||||||ANOVA|A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores between groups and CDP-Choline or placebo||A repeated measure ANOVA was completed to evaluate potential differences in cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo.|
1718134|NCT00727246|3162946|Other|||||||0.85|||||||ANOVA|A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores between groups and CDP-Choline or placebo||A repeated measures ANOVA was completed to evaluate differences in cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. A mean index score created as a composite cognitive performance across domains (higher t-score = higher cognition). Purpose was to serve as a measure of overall cognitive functioning for data analysis.|
1718135|NCT00727194|3162951|Superiority or Other (legacy)||Median Difference (Final Values)|-6.57||||0.2292|2-Sided|95.0|-17.87|4.73||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Negative Inspiratory Force|
1718136|NCT00727194|3162951|Superiority or Other (legacy)||Mean Difference (Net)|0.0||||1|2-Sided|95.0|-4.35|4.35||No multiple comparisons or multiplicity adjustments were conducted.|paired t test|||Negative Inspiratory Force|
1718137|NCT00727194|3162951|Superiority or Other (legacy)||Median Difference (Net)|-10.57||||0.3391|2-Sided|95.0|-33.71|12.56||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Forced Vital Capacity|
1718138|NCT00727194|3162951|Superiority or Other (legacy)||Mean Difference (Net)|3.25||||0.3377|2-Sided|95.0|-3.94|10.44||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Forced Vital Capacity|
1718139|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|5.55||||0.4151|2-Sided|95.0|-8.77|19.87||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Mental Component Score|
1718140|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|-2.92||||0.1505|2-Sided|95.0|-7.1|1.26||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Mental Component Score|
1718141|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|-6.23||||0.2226|2-Sided|95.0|-16.79|4.32||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Physical Component Score|
1718142|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|1.07||||0.6807|2-Sided|95.0|-4.57|6.72||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Physical Component Score|
1718143|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|17.86||||0.1519|2-Sided|95.0|-7.57|43.29||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Mental Health|
1718144|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|0.42||||0.9007|2-Sided|95.0|-6.83|7.67||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Mental Health|
1718145|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|5.95||||0.7422|2-Sided|95.0|-32.58|44.48||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Role Emotional|
1718146|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|-11.81||||0.1701|2-Sided|95.0|-29.6|5.99||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Role Emotional|
1718147|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|-16.07||||0.1966|2-Sided|95.0|-41.68|9.54||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Social Functioning|
1718148|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|-11.46||||0.0716|2-Sided|95.0|-24.13|1.21||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Social Functioning|
1718149|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|-2.68||||0.8085|2-Sided|95.0|-26.24|20.88||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Vitality|
1718150|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|4.17||||0.2474|2-Sided|95.0|-3.39|11.72||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Vitality|
1718151|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|7.43||||0.5073|2-Sided|95.0|-16.26|31.11||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||General Health|
1718152|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|7.17||||0.0578|2-Sided|95.0|-0.29|14.62||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||General Health|
1718153|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|-14.86||||0.2406|2-Sided|95.0|-41.08|11.36||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Bodily Pain|
1718154|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|-9.42||||0.1311|2-Sided|95.0|-22.18|3.34||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Bodily Pain|
1718155|NCT00727194|3162952|Superiority or Other (legacy)||Median Difference (Net)|-7.14||||0.691|2-Sided|95.0|-45.36|31.08||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Role Physical|
1718156|NCT00727194|3162952|Superiority or Other (legacy)||Median Difference (Net)|3.13||||0.7319|2-Sided|95.0|-16.64|22.89||No multiple comparisons or multiplicity adjustments were conducted.|Paired t-test|||Role Physical|
1718157|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|-7.86||||0.5931|2-Sided|95.0|-39.05|23.33||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided|||Physical Functioning|
1718158|NCT00727194|3162952|Superiority or Other (legacy)||Mean Difference (Net)|0.83||||0.919|2-Sided|95.0|-16.94|18.6||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test|||Physical Functioning|
1718159|NCT00727194|3162953|Superiority or Other (legacy)||Mean Difference (Net)|-3.57||||0.041|2-Sided|95.0|-6.97|-0.17||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided||||
1718160|NCT00727194|3162953|Superiority or Other (legacy)||Mean Difference (Net)|-1.58||||0.1873|2-Sided|95.0|-4.08|0.91||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test||||
1718161|NCT00727194|3162954|Superiority or Other (legacy)|||||||0.0606||||||No multiple comparisons or multiplicity adjustments were conducted.|Chi-squared||||
1718162|NCT00727194|3162954|Superiority or Other (legacy)|||||||1||||||No multiple comparisons or multiplicity adjustments were conducted.|Chi-squared||||
1718163|NCT00727194|3162955|Superiority or Other (legacy)||Mean Difference (Net)|-4.71||||0.117|2-Sided|95.0|-10.8|1.37||No multiple comparisons or multiplicity adjustments were conducted.|t-test, 2 sided||||
1718164|NCT00727194|3162955|Superiority or Other (legacy)||Mean Difference (Net)|-4.25||||0.0144|2-Sided|95.0|-7.45|-1.05||No multiple comparisons or multiplicity adjustments were conducted.|paired t-test||||
1718165|NCT00727090|3162964|Non-Inferiority or Equivalence|Equivalence|||||<|0.05|||||||t-test, 2 sided|||Null Hypothesis: Change in serum sodium from baseline is not different between groups|
1718166|NCT00727064|3162965|Superiority or Other|||||||0.427|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.|||
1718167|NCT00727064|3162966|Superiority or Other|||||||0.081|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.|||
1718168|NCT00727064|3162967|Superiority or Other|||||||0.018|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.|||
1718169|NCT00727064|3162968|Superiority or Other|||||||0.004|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.|||
1718170|NCT00727064|3162969|Superiority or Other||||||<|0.001|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.|||
1718171|NCT00727064|3162970|Superiority or Other||||||<|0.001|||||||ANOVA|PM compared to EM using least squares geometric means. Analysis of variance with phenotype and sequence as factors.|||
1718172|NCT00726713|3163008|Superiority or Other||||||=|0|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||HADS Depression, Change from BL, Week 24|
1718173|NCT00726713|3163011|Superiority or Other||||||=|0||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||SF-36 MCS, Change from BL, Week 24|
1718174|NCT00726713|3163012|Superiority or Other||||||=|0|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total Homocysteine, Change from BL, Week 24|
1718175|NCT00726713|3163012|Superiority or Other||||||=|0||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Homocysteine, Change from BL, Week 16|
1718176|NCT00726713|3163012|Superiority or Other||||||=|0|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total MMA, Change from BL, Week 24|
1718177|NCT00726713|3163012|Superiority or Other||||||=|0|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Total MMA, Change from Baseline Week 16|
1718178|NCT00726713|3163012|Superiority or Other||||||=|0||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Folate, Change from BL, Week 24|
1718179|NCT00726713|3163012|Superiority or Other||||||=|0||||||Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes|Mixed Models Analysis|||Total Folate, Change from BL, Week 16|
1718180|NCT00726713|3163013|Superiority or Other||||||=|0|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 16|
1718181|NCT00726713|3163014|Superiority or Other||||||=|0|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 24|
1718182|NCT00726713|3163014|Superiority or Other||||||=|0|||||||Mixed Models Analysis|Generalized linear mixed models were used to assess baseline for continuous and discrete outcomes||Change from Baseline, Week 16|
1718183|NCT00726622|3163034|Non-Inferiority or Equivalence (legacy)|Assuming a baseline rate of 90% oncologic success for the open resection arm, the sample size provided 80% power to declare non-inferiority if oncologic success rates were truly identical, using a 1-sided z score with α = .10 for falsely declaring non-inferiority when the true oncologic success rate for laparoscopic resection was 84%. Calculations were based on a 2-sample binomial non-inferiority calculation with a 90% success rate for the control group and a 6% non-inferiority margin.||||||0.41|||||||Wilcoxon (Mann-Whitney)||||
1718184|NCT00725985|3163076|Superiority or Other||Hazard Ratio (HR)|0.496|||<|0.0001|2-Sided|95.0|0.389|0.631||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test||||
1718185|NCT00725985|3163076|Superiority or Other||Hazard Ratio (HR)|0.425|||<|0.0001|2-Sided|95.0|0.331|0.546||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test||||
1718186|NCT00725985|3163077|Superiority or Other||Hazard Ratio (HR)|0.327|||<|0.0001|2-Sided|95.0|0.21|0.509||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test||||
1718187|NCT00725985|3163077|Superiority or Other||Hazard Ratio (HR)|0.381|||<|0.0001|2-Sided|95.0|0.249|0.584||The treatment effect was also assessed by hazard ratios using the Cox's proportional hazards model.|two-sided Wald test||||
1718188|NCT00725920|3163080|Superiority or Other|||||||0.0076|||||||t-test, 2 sided||||
1718189|NCT00725725|3163105|Superiority or Other||Mean Difference (Final Values)|-6.1867||||0.0256|2-Sided|95.0|-11.5864|-0.7869|||Mixed Models Analysis||||
1718190|NCT00725725|3163105|Superiority or Other||Mean Difference (Final Values)|-1.2766||||0.6516|2-Sided|95.0|-6.9269|4.3738|||Mixed Models Analysis||||
1718191|NCT00725725|3163106|Superiority or Other||Mean Difference (Final Values)|1.526||||0.5488|2-Sided|95.0|-3.5495|6.6015|||Mixed Models Analysis||||
1718192|NCT00725725|3163106|Superiority or Other||Mean Difference (Final Values)|0.7296||||0.7895|2-Sided|95.0|-4.7291|6.1883|||Mixed Models Analysis||||
1718193|NCT00725725|3163107|Superiority or Other||Mean Difference (Final Values)|2.0291||||0.661|2-Sided|95.0|-7.2132|11.2714|||Mixed Models Analysis||||
1718345|NCT00721799|3163761|Other||C-statistic|0.7||||0.05|2-Sided||||||Regression, Cox||||
1718194|NCT00725725|3163107|Superiority or Other||Mean Difference (Final Values)|-1.2502||||0.8073|2-Sided|95.0|-11.4963|8.9958|||Mixed Models Analysis||||
1718195|NCT00725725|3163108|Superiority or Other||Mean Difference (Final Values)|2.0417||||0.3765|2-Sided|95.0|-2.5526|6.636|||Mixed Models Analysis||||
1718196|NCT00725725|3163108|Superiority or Other||Mean Difference (Final Values)|0.3456||||0.8894|2-Sided|95.0|-4.6211|5.3124|||Mixed Models Analysis||||
1718197|NCT00725725|3163112|Superiority or Other||Mean Difference (Final Values)|3.1317||||0.0844|2-Sided|95.0|-0.4518|6.7152|||Mixed Models Analysis||||
1718198|NCT00725725|3163112|Superiority or Other||Mean Difference (Final Values)|2.3356||||0.2683|2-Sided|95.0|-1.8933|6.5644|||Mixed Models Analysis||||
1718199|NCT00725725|3163113|Superiority or Other||Mean Difference (Final Values)|-0.4414||||0.777|2-Sided|95.0|-3.5952|2.7124|||Mixed Models Analysis||||
1718200|NCT00725725|3163113|Superiority or Other||Mean Difference (Final Values)|-1.8246||||0.3597|2-Sided|95.0|-5.8307|2.1815|||Mixed Models Analysis||||
1718201|NCT00725725|3163114|Superiority or Other||Mean Difference (Final Values)|1.2667||||0.3515|2-Sided|95.0|-1.4665|4.0|||Mixed Models Analysis||||
1718202|NCT00725725|3163114|Superiority or Other||Mean Difference (Final Values)|1.5299||||0.3934|2-Sided|95.0|-2.0781|5.138|||Mixed Models Analysis||||
1718203|NCT00725491|3163152|Superiority or Other||||||<|0.001|||||||Cochran-Whitehead||||
1718204|NCT00725270|3163179|Superiority or Other||eta sq|0.157||||0.203|2-Sided||||||Mixed Models Analysis||||
1718205|NCT00725270|3163180|Superiority or Other|||||||0.812|||||||Mixed Models Analysis|||Repeated Measures ANOVA was run on the Positive Symptom Scale of the Brief Psychiatric Rating Scale, using Baseline and Day 9 ratings. Below is the medication * time interaction.|
1718206|NCT00725101|3163199|Superiority or Other|||||||0.05||||||P-value for NSAID use.|Regression, Logistic||||
1718207|NCT00725101|3163199|Superiority or Other|||||||0.021||||||P-value for pregabalin use.|Regression, Logistic||||
1718208|NCT00725101|3163199|Superiority or Other|||||||0.026||||||P-value for GAD-7 score.|Regression, Logistic||||
1718209|NCT00725101|3163200|Superiority or Other||||||<|0.0001||||||P-value for number of medications participants were taking.|Regression, Logistic||||
1718210|NCT00725101|3163200|Superiority or Other||||||<|0.0001||||||P-value for use of NSAIDs.|Regression, Logistic||||
1718211|NCT00725101|3163200|Superiority or Other||||||<|0.0064||||||P-value for use of opioids.|Regression, Logistic||||
1718212|NCT00725101|3163200|Superiority or Other||||||<|0.0001||||||P-value for other specialty versus PCP.|Regression, Logistic||||
1718213|NCT00725101|3163200|Superiority or Other||||||<|0.0001||||||P-value for Rheumatology versus PCP.|Regression, Logistic||||
1718214|NCT00725101|3163200|Superiority or Other||||||<|0.0028||||||P-value for female physicians.|Regression, Logistic||||
1718215|NCT00725101|3163200|Superiority or Other||||||<|0.0074||||||P-value for age over 65.|Regression, Logistic||||
1718216|NCT00725075|3163214|Superiority or Other||Mean Change From Baseline|-0.08||||0.966|2-Sided|95.0|-3.91|3.74|||ANCOVA|ANCOVA model with the baseline value as covariate and with treatment group and center as fixed factors||Comparison of Mean Change in Baseline: Least Squared Estimates with Statistical Inference.|
1718217|NCT00725075|3163214|Superiority or Other||Mean Change From Baseline|-2.26||||0.267|2-Sided|95.0|-6.25|1.74|||ANCOVA|ANCOVA model with the baseline value as covariate and with treatment group and center as fixed factors||Comparison of Mean Change in Baseline: Least Squared Estimates with Statistical Inference.|
1718218|NCT00724945|3163238|Non-Inferiority or Equivalence|The non-inferiority margin is -0.5.|Mean Difference (Final Values)|0.07407|Standard Error of the Mean|0.1279||||97.5|-0.1797|0.07407|||||Mean difference was calculated as senofilcon A multifocal minus balafilcon A multifocal.|Alternative hypothesis: senofilcon A multifocal lens will have subjective vision that is non-inferior to balafilcon A multifocal.|
1718219|NCT00724945|3163239|Superiority or Other||Least Square Mean|0.02711|Standard Error of the Mean|0.008816||||97.5|0.02711|0.04445||||||Alternative hypothesis: senofilcon A multifocal lens would be better than or equal to 0.17 logMAR units.|
1718220|NCT00724945|3163240|Superiority or Other||Least Square Mean|-0.08591|Standard Error of the Mean|0.008816||||95.0|-0.08591|-0.06857||||||Alternative hypothesis: senofilcon A multifocal would be better than or equal to 0.1 logMAR units.|
1718221|NCT00724932|3163265|Superiority or Other||Geometric Mean Ratio (Final Values)|2.9|||<|0.0001|2-Sided|95.0|2.5|3.4||The p-value is not adjusted for multiplicity.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.8 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.8 was calculated using a two-way ANOVA model adjusted for treatment group and trial site.|
1718222|NCT00724932|3163273|Superiority or Other||Geometric Mean Ratio (Final Values)|2.5|||<|0.0001|2-Sided|95.0|2.1|2.8||The p-value is not adjusted for multiplicity.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.7 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.7 was calculated using a two-way ANOVA model adjusted for treatment group and trial site.|
1718223|NCT00724932|3163274|Superiority or Other||Geometric Mean Ratio (Final Values)|3.4|||<|0.0001|2-Sided|95.0|2.8|4.1||Testing was performed using a two-sided test at the 0.05 significance level. There was only one primary comparison, therefore no adjustment for multiplicity was required.|ANOVA||Sugammadex is the numerator and neostigmine the denominator. The estimated value for the geometric mean ratio presents how many times the geometric mean time to recovery of the T4/T1 ratio to 0.9 was faster with sugammadex compared to neostigmine.|To evaluate the efficacy of sugammadex compared to neostigmine, the ratio of the geometric means of time to recovery of the T4/T1 ratio to 0.9 was calculated using a two-way analysis of variance (ANOVA) model adjusted for treatment group and trial site.|
1718224|NCT00724750|3163369|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1718225|NCT00724750|3163370|Superiority or Other|||||||0.02|||||||Mixed Models Analysis||||
1718226|NCT00724750|3163371|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1718227|NCT00724750|3163373|Non-Inferiority or Equivalence|The non-inferiority margin was 5%/day.||||||0.19||||||The rate of change for the 2 groups was compared by testing the treatment-by-time interaction.|Mixed Models Analysis||||
1718228|NCT00724750|3163374|Non-Inferiority or Equivalence|The non-inferiority margin was 5%/day. For 80% power and a significance (alpha) level of 0.05; and assuming a common standard deviation of 9%, 41 subjects per group were needed.||||||0.6||||||The rate of change for the 2 groups was compared by testing the treatment-by-time interaction in the model.|Mixed Models Analysis||||
1718229|NCT00724711|3163388|Non-Inferiority or Equivalence|"This study was designed to show noninferiority (change of < 12%) in regard of proportions of responders (TLOVR) at Week 48.~With 170 subjects in each group, the lower limit of observed one-sided 97.5% confidence interval was expected to be greater than −0.120 with 80% power when the proportion of responders in both treatment groups is 0.820 (82%) at Week 48.~312 subjects were enrolled, representing 8% less than planned (n = 340). As a result, power to claim non-inferiority decreased to 78%."|Difference in percentages between groups|3.0|||||2-Sided|95.0|-5.1|11.2||||||"Null hypothesis: The TVD group is at least 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA < 200 copies/mL through Week 48 (“responder rate”, as defined by the TLOVR algorithm)~Alternative hypothesis: The TVD group is less than 12% worse than the ABC/3TC group with respect to the percentage of subjects maintaining HIV-1 RNA < 200 copies/mL through Week 48 (“responder rate”, as defined by the TLOVR algorithm)"|
1718230|NCT00724594|3163390|Other|||||||0.014|||||||t-test, 2 sided||||
1718231|NCT00724594|3163391|Other|||||||0.072|||||||t-test, 2 sided|||correcting for gestational age at birth|
1718232|NCT00724594|3163392|Other|||||||0.9|||||||t-test, 2 sided|||Infant cohort: NAC versus control H0= prothrombin time will not be different in the infants after NAC or saline|
1718233|NCT00724594|3163392|Other|||||||0.9||||||not significant|t-test, 2 sided|||Maternal cohort: NAC versus control l H0= PT will not be different in mothers after NAC or saline|
1718234|NCT00724594|3163393|Other|||||||0.9|||||||t-test, 2 sided|||Preterm infant cohort: NAC vs control H0= there will be no difference in resisitive index in MCA after N-acetylcysteine or saline in preterm cohort|
1718235|NCT00724594|3163393|Other|||||||0.9||||||not significant|t-test, 2 sided|||Term infant cohort : NAC vs control H0= there will be no difference in resistive index in Middle Cerebral Artery after N-acetylcysteine or saline in the term cohort.|
1718236|NCT00724503|3163402|Superiority||Hazard Ratio (HR)|0.75|||<|0.05|2-Sided|95.0|||||Log Rank|||A sample size of at least 450 patients for the SIRFLOX study was estimated to be needed to detect an increase in the median PFS at any site from 9.4 months to 12.5 months with 80% power and 95% confidence. Taking into account the number of patients who might receive the alternative treatment or lack of imaging data, the sample size was increased to 530. The Null hypothesis is no difference between the treatment arms with respect to PFS.|
1718237|NCT00724503|3163403|Superiority||Hazard Ratio (HR)|0.93||||0.551|2-Sided|95.0|0.77|1.12|||Log Rank|||The null hypothesis tested for the primary efficacy endpoint is rate of progression (months) of SIRT/FOLFOX treatment versus FOLFOX is equal for both groups. The two-sided alternative hypothesis tested with 95% confidence is PFS rate for SIRT/FOLFOX treatment lower to that of FOLFOX.|
1718238|NCT00724152|3163428|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|||Null hypothesis: The Cognitive Behavioral Therapy group would not demonstrate decreased distress at post-treatment as compared to the Tinnitus Education group on the primary outcome measure (THI) between pre-treatment and post-treatment.|
1718239|NCT00724126|3163429|Superiority or Other (legacy)|||||||0.02|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.|||
1718240|NCT00724126|3163430|Superiority or Other (legacy)|||||||0.03|||||||Regression, Logistic|The p-value was obtained from a logistic regression model with fixed effects for treatment arm and analysis center.|||
1718241|NCT00723957|3163445|Superiority or Other||Hazard Ratio (HR)|1.1|||||1-Sided|90.0||1.4|||||Overall population||
1718242|NCT00723957|3163445|Superiority or Other||Hazard Ratio (HR)|0.7|||||1-Sided|90.0||0.9|||||β3T- subgroup||
1718243|NCT00723957|3163445|Superiority or Other||Hazard Ratio (HR)|1.6|||||1-Sided|90.0||2.1|||||β3T+ subgroup||
1718244|NCT00723957|3163451|Superiority or Other|||||||0.316|||||||Log Rank|||P-value is 1-sided|
1718245|NCT00723957|3163451|Superiority or Other||Hazard Ratio (HR)|0.92|||||1-Sided|90.0||1.15|||||||
1718246|NCT00723957|3163452|Superiority or Other|||||||0.175|||||||Log Rank|||P-value is 1-sided|
1718247|NCT00723957|3163452|Superiority or Other||Hazard Ratio (HR)|0.78|||||1-Sided|90.0||1.1|||||||
1718248|NCT00723957|3163453|Superiority or Other|||||||0.5735|||||||Log Rank|||P-value is 1-sided|
1718249|NCT00723957|3163453|Superiority or Other||Hazard Ratio (HR)|1.04|||||1-Sided|90.0||1.41|||||||
1718250|NCT00723554|3163512|Superiority or Other||Mean Difference (Net)|11.0|||<|0.0001|2-Sided|95.0|6.5|15.6|||t-test, 2 sided|||Comparison of the change in percentage of complete doses delivered from Period I (PD-6) to Period II (PD-15)|
1718251|NCT00723554|3163516|Superiority or Other||Mean Difference (Net)|0.5|||<|0.001|2-Sided|95.0|0.2|0.7|||t-test, 2 sided|||Comparison of the change in average number of daily doses from Period I (PD-6) to Period II (PD-15)|
1718252|NCT00723554|3163520|Superiority or Other||Mean Difference (Net)|-0.2||||0.59|2-Sided|95.0|-1.0|0.6|||t-test, 2 sided|||Comparison of the change in average number of days of dosing from Period I (PD-6) to Period II (PD-15)|
1718253|NCT00723554|3163524|Superiority or Other||Mean Difference (Net)|-6.1|||<|0.001|2-Sided|95.0|-6.9|-5.4|||t-test, 2 sided|||Comparison of the change in average inhalation times from Period I (PD-6) to Period II (PD-15)|
1718254|NCT00723528|3163547|Superiority or Other||||||<|0.0001||||||Fisher's exact test (using Holm's method)|Fisher Exact||||
1718255|NCT00723528|3163557|Superiority or Other||||||<|0.0001||||||2-sample t-test (using Holm's method)|t-test, 2 sided||||
1718256|NCT00723528|3163558|Superiority or Other||||||<|0.0001||||||Fisher's exact test (using Holm's method)|Fisher Exact||||
1718284|NCT00722137|3163711|Superiority or Other||Hazard Ratio (HR)|0.5|||<|0.001|2-Sided|95.0|0.38|0.65|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio < 1 indicates an advantage for VcR-CAP.||
1718257|NCT00723489|3163559|Superiority or Other||Mean Difference (Final Values) Day 30|-0.4||||0.045|2-Sided|95.0|-0.7|-0.01||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) – Mean (Non-AD)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing|
1718258|NCT00723489|3163560|Superiority or Other||Mean Difference (Final Values) Day 30|0.04||||0.82|2-Sided|95.0|-0.3|0.4||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) – Mean (Non-AD)|This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC –(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing|
1718259|NCT00723489|3163561|Superiority or Other||Mean Difference (Final Values) Day 30|-0.3||||0.036|2-Sided|95.0|-0.5|-0.02||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) – Mean (Non-AD)|Participants who did not seroconvert were excluded from this analysis (2 TC-(AD) and 5 TC-(Non-AD)). T-cell data from 4 TC-(AD) and 3 TC-(Non-AD) subjects was excluded due to problems with sample processing|
1718260|NCT00723489|3163562|Superiority or Other||Mean Difference (Final Values) Day 30|0.1||||0.48|2-Sided|95.0|-0.1|0.3||P-value is not adjusted for multiple comparisons.|Mixed Models Analysis||Mean (AD) – Mean (Non-AD)|This analysis excludes 1 SC-(AD) participant who did not seroconvert. Only participants who had peripheral blood T-cell samples collected from Day 0 to Day 30 as specified in the Outcome Measure Time Frame were included in analysis (1 SC –(Non-AD) participant was excluded). T-cell data from 3 SC-(Non-AD) and 1 SC-(AD) participant was excluded due to problems with sample processing|
1718261|NCT00723489|3163563|Superiority or Other|||||||0.43||||||P-value is not adjusted for multiple comparisons.|Fisher Exact||||
1718262|NCT00723489|3163564|Superiority or Other|||||||0.24||||||P-value is not adjusted for multiple comparisons.|Fisher Exact||||
1718263|NCT00723489|3163565|Superiority or Other||Mean Difference (Final Values)|0.1||||0.66|2-Sided|95.0|-0.2|0.3||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) – Mean (Non-AD)||
1718264|NCT00723489|3163566|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.1|2-Sided|95.0|-0.5|0.05||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) – Mean (Non-AD)||
1718265|NCT00723489|3163567|Superiority or Other||Mean Difference (Final Values)|0.02||||0.86|2-Sided|95.0|-0.2|0.2||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) – Mean (Non-AD)||
1718266|NCT00723489|3163568|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.86|2-Sided|95.0|-0.3|0.2||P-value is not adjusted for multiple comparisons.|ANOVA||Mean (AD) – Mean (Non-AD)||
1718267|NCT00723450|3163590|Superiority or Other|||||||0.0717|||||||Log Rank|A stratified log rank test was performed where the stratification factor was the index mood state at Screen visit.|||
1718268|NCT00723229|3163620|Superiority|Adjusted for period effects.|Risk Ratio (RR)|0.5|||<|0.001|2-Sided|95.0|0.4|0.6|||Regression, Poisson|||Among HIV seropositive individuals.|
1718269|NCT00723229|3163620|Superiority|Adjusted for period effects.|Risk Ratio (RR)|0.05|||<|0.001|2-Sided|95.0|0.03|0.08|||Regression, Poisson|||Among HIV seronegative individuals.|
1718270|NCT00723229|3163620|Superiority or Other||Incidence Risk Ratio|0.2|||<|0.001|2-Sided|95.0|0.17|0.25|||Regression, poisson|Adjusted for period effects.||The trial had 80% power to detect a 35% reduction in genital shedding rates for acyclovir 400 mg twice daily.|
1718271|NCT00723073|3163647|Superiority or Other|||||||0.11|||||||Fisher Exact||||
1718272|NCT00723073|3163648|Superiority or Other|||||||0.22|||||||Fisher Exact||||
1718273|NCT00723073|3163651|Superiority or Other|||||||0.66|||||||Chi-squared||||
1718274|NCT00723073|3163652|Superiority or Other||Risk Ratio (RR)|0.57|Standard Deviation|1.0||0.57|2-Sided|95.0|0.1|3.37|||Fisher Exact||||
1718275|NCT00723073|3163653|Superiority or Other||Risk Ratio (RR)|1.12|Standard Deviation|1.0||0.48|2-Sided|95.0|0.61|2.07|||Fisher Exact||||
1718276|NCT00723073|3163654|Superiority or Other||Risk Ratio (RR)|0.93|Standard Deviation|1.0|>|0.99|2-Sided|95.0|0.44|1.97|||Fisher Exact||||
1718277|NCT00723073|3163655|Superiority or Other||Risk Ratio (RR)|1.0|Standard Deviation|1.0|>|0.99|2-Sided|95.0|0.38|2.7|||Fisher Exact||||
1718278|NCT00723073|3163656|Superiority or Other||Risk Ratio (RR)|0.99|Standard Deviation|1.0||0.96|2-Sided|95.0|0.89|1.1|||Fisher Exact||||
1718279|NCT00722566|3163686|Non-Inferiority or Equivalence|Assuming ORRs are 35.5% for both SC and IV, one-sided alpha level of 0.025, and approximately 80% power, approximately 216 subjects (144 SC:72 IV) are needed to show non-inferiority of SC to IV VELCADE.|ORR_SQ - 0.6 ORR_IV|16.8||||0.00201|2-Sided|95.0|6.1|27.1|||Farrrington and Manning|CONOR P. FARRINGTON AND GODFREY MANNING STATISTICS IN MEDICINE, VOL. 9, 1447-1454(1990).||In this trial, non-inferiority is defined as retaining 60% of the IV (active control) treatment effect as measured by ORR. The non-inferiority hypothesis can be stated as: H0: ORRSC – 0.60 ORRIV <0 vs. H1: ORRSC – 0.60 ORRIV ≥0 (non-inferiority).|
1718280|NCT00722137|3163707|Superiority or Other||Hazard Ratio (HR)|0.8||||0.173|2-Sided|95.0|0.59|1.1|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio < 1 indicates an advantage for VcR-CAP.||
1718281|NCT00722137|3163708|Superiority or Other||Odds Ratio (OR)|1.688|||<|0.007|2-Sided|95.0|1.148|2.481|||Cochran-Mantel-Haenszel Chi-Square||Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) > 1 indicates an advantage for VcR-CAP.||
1718282|NCT00722137|3163709|Superiority or Other||Odds Ratio (OR)|1.428||||0.275|2-Sided|95.0|0.749|2.722|||Cochran-Mantel-Haenszel Chi-Square||Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and Stage of Disease as stratification factors. An odds ratio (OR) > 1 indicates an advantage for VcR-CAP.||
1718283|NCT00722137|3163710|Superiority or Other||Hazard Ratio (HR)|0.5|||=|0|2-Sided|95.0|0.38|0.65|||Log Rank||||
1718340|NCT00721799|3163758|Other||Hazard Ratio (HR)|0.94||||0.89|2-Sided||||||Regression, Cox||||
1718341|NCT00721799|3163759|Other||C-statistic|0.6||||0.36|2-Sided||||||Regression, Cox||||
1718285|NCT00722137|3163713|Superiority or Other||Hazard Ratio (HR)|0.58|||<|0.001|2-Sided|95.0|0.45|0.74|||Log Rank|Based on Log rank test stratified with IPI risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio < 1 indicates an advantage for VcR-CAP.||
1718286|NCT00722137|3163714|Superiority or Other||Hazard Ratio (HR)|0.63|||<|0.001|2-Sided|95.0|0.5|0.79|||Log Rank|Based on Log rank test stratified with International Prognostic Index (IPI) risk and stage of disease.|Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio < 1 indicates an advantage for VcR-CAP.||
1718287|NCT00722124|3163715|Superiority or Other|||||||0.826|||||||Fisher Exact|1 sided||Data were compared between treatment groups using Fisher's Exact test.|
1718288|NCT00722124|3163715|Superiority or Other|||||||0.615|||||||Fisher Exact|1 sided||Data were compared between treatment groups using Fisher's Exact test.|
1718289|NCT00721955|3163733|Superiority||||||<|0.0001||||||-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA||||
1718290|NCT00721955|3163733|Superiority|LS mean was used in the primary efficacy analysis|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA||||
1718291|NCT00721955|3163734|Superiority|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA||||
1718292|NCT00721955|3163734|Superiority|LS mean was used in the primary efficacy analysis|||||<|0.0001||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA||||
1718293|NCT00721799|3163735|Other||C-statistic|0.63||||0.24|2-Sided||||||Regression, Cox||||
1718294|NCT00721799|3163735|Other||Hazard Ratio (HR)|1.56||||0.2|2-Sided||||||Regression, Cox||||
1718295|NCT00721799|3163736|Other||C-statistic|0.56||||0.63|2-Sided||||||Regression, Cox||||
1718296|NCT00721799|3163736|Other||Hazard Ratio (HR)|1.35||||0.36|2-Sided||||||Regression, Cox||||
1718297|NCT00721799|3163737|Other||C-statistic|0.52||||0.87|2-Sided||||||Regression, Cox||||
1718298|NCT00721799|3163737|Other||Hazard Ratio (HR)|1.05||||0.9|2-Sided||||||Regression, Cox||||
1718299|NCT00721799|3163738|Other||C-statistic|0.59||||0.46|2-Sided||||||Regression, Cox||||
1718300|NCT00721799|3163738|Other||Hazard Ratio (HR)|1.38||||0.37|2-Sided||||||Regression, Cox||||
1718301|NCT00721799|3163739|Other||C-statistic|0.59||||0.46|2-Sided||||||Regression, Cox||||
1718302|NCT00721799|3163739|Other||Hazard Ratio (HR)|1.51||||0.26|2-Sided||||||Regression, Cox||||
1718303|NCT00721799|3163740|Other||C-statistic|0.74||||0.03|2-Sided||||||Regression, Cox||||
1718304|NCT00721799|3163740|Other||Hazard Ratio (HR)|2.39|||<|0.01|2-Sided||||||Regression, Cox||||
1718305|NCT00721799|3163741|Other||C-statistic|0.48||||0.88|2-Sided||||||Regression, Cox||||
1718306|NCT00721799|3163741|Other||Hazard Ratio (HR)|1.32||||0.4|2-Sided||||||Regression, Cox||||
1718307|NCT00721799|3163742|Other||C-statistic|0.71||||0.11|2-Sided||||||Regression, Cox||||
1718308|NCT00721799|3163742|Other||Hazard Ratio (HR)|0.81||||0.67|2-Sided||||||Regression, Cox||||
1718309|NCT00721799|3163743|Other||C-statistic|0.63||||0.28|2-Sided||||||Regression, Cox||||
1718310|NCT00721799|3163743|Other||Hazard Ratio (HR)|0.74||||0.48|2-Sided||||||Regression, Cox||||
1718311|NCT00721799|3163744|Other||C-statistic|0.61||||0.35|2-Sided||||||Regression, Cox||||
1718312|NCT00721799|3163744|Other||Hazard Ratio (HR)|0.78||||0.55|2-Sided||||||Regression, Cox||||
1718313|NCT00721799|3163745|Other||C-statistic|0.74||||0.03|2-Sided||||||Regression, Cox||||
1718314|NCT00721799|3163745|Other||Hazard Ratio (HR)|2.99|||<|0.01|2-Sided||||||Regression, Cox||||
1718315|NCT00721799|3163746|Other||C-statistic|0.45||||0.68|2-Sided||||||Regression, Cox||||
1718316|NCT00721799|3163746|Other||Hazard Ratio (HR)|1.11||||0.76|2-Sided||||||Regression, Cox||||
1718317|NCT00721799|3163747|Other||C-statistic|0.48||||0.84|2-Sided||||||Regression, Cox||||
1718318|NCT00721799|3163747|Other||Hazard Ratio (HR)|1.03||||0.92|2-Sided||||||Regression, Cox||||
1718319|NCT00721799|3163748|Other||C-statistic|0.82|||<|0.01|2-Sided||||||Regression, Cox||||
1718320|NCT00721799|3163748|Other||Hazard Ratio (HR)|3.01|||<|0.01|2-Sided||||||Regression, Cox||||
1718321|NCT00721799|3163749|Other||C-statistic|0.74||||0.04|2-Sided||||||Regression, Cox||||
1718322|NCT00721799|3163749|Other||Hazard Ratio (HR)|0.36||||0.06|2-Sided||||||Regression, Cox||||
1718323|NCT00721799|3163750|Other||Hazard Ratio (HR)|0.72||||0.06|2-Sided||||||Regression, Cox||||
1718324|NCT00721799|3163750|Other||Hazard Ratio (HR)|0.42||||0.09|2-Sided||||||Regression, Cox||||
1718325|NCT00721799|3163751|Other||C-statistic|0.64||||0.18|2-Sided||||||Regression, Cox||||
1718326|NCT00721799|3163751|Other||Hazard Ratio (HR)|1.56||||0.17|2-Sided||||||Regression, Cox||||
1718327|NCT00721799|3163752|Other||C-statistic|0.54||||0.69|2-Sided||||||Regression, Cox||||
1718328|NCT00721799|3163752|Other||Hazard Ratio (HR)|1.3||||0.41|2-Sided||||||Regression, Cox||||
1718329|NCT00721799|3163753|Other||C-statistic|0.48||||0.84|2-Sided||||||Regression, Cox||||
1718330|NCT00721799|3163753|Other||Hazard Ratio (HR)|1.0||||0.99|2-Sided||||||Regression, Cox||||
1718331|NCT00721799|3163754|Other||C-statistic|0.62||||0.27|2-Sided||||||Regression, Cox||||
1718332|NCT00721799|3163754|Other||Hazard Ratio (HR)|1.49||||0.24|2-Sided||||||Regression, Cox||||
1718333|NCT00721799|3163755|Other||C-statistic|0.63||||0.25|2-Sided||||||Regression, Cox||||
1718334|NCT00721799|3163755|Other||Hazard Ratio (HR)|1.58||||0.18|2-Sided||||||Regression, Cox||||
1718335|NCT00721799|3163756|Other||C-statistic|0.69||||0.07|2-Sided||||||Regression, Cox||||
1718336|NCT00721799|3163756|Other||Hazard Ratio (HR)|2.01||||0.01|2-Sided||||||Regression, Cox||||
1718337|NCT00721799|3163757|Other||C-statistic|0.47||||0.8|2-Sided||||||Regression, Cox||||
1718338|NCT00721799|3163757|Other||Hazard Ratio (HR)|1.29||||0.43|2-Sided||||||Regression, Cox||||
1718339|NCT00721799|3163758|Other||C-statistic|0.59||||0.42|2-Sided||||||Regression, Cox||||
1718346|NCT00721799|3163761|Other||Hazard Ratio (HR)|2.25||||0.01|2-Sided||||||Regression, Cox||||
1718347|NCT00721799|3163762|Other||C-statistic|0.45||||0.66|2-Sided||||||Regression, Cox||||
1718348|NCT00721799|3163762|Other||Hazard Ratio (HR)|1.11||||0.78|2-Sided||||||Regression, Cox||||
1718349|NCT00721799|3163763|Other||C-statistic|0.52||||0.88|2-Sided||||||Regression, Cox||||
1718350|NCT00721799|3163763|Other||Hazard Ratio (HR)|1.12||||0.73|2-Sided||||||Regression, Cox||||
1718351|NCT00721799|3163764|Other||C-statistic|0.74||||0.02|2-Sided||||||Regression, Cox||||
1718352|NCT00721799|3163764|Other||Hazard Ratio (HR)|2.44|||<|0.01|2-Sided||||||Regression, Cox||||
1718353|NCT00721799|3163765|Other||C-statistic|0.75||||0.02|2-Sided||||||Regression, Cox||||
1718354|NCT00721799|3163765|Other||Hazard Ratio (HR)|0.42||||0.05|2-Sided||||||Regression, Cox||||
1718355|NCT00721799|3163766|Other||C-statistic|0.73||||0.04|2-Sided||||||Regression, Cox||||
1718356|NCT00721799|3163766|Other||Hazard Ratio (HR)|0.47||||0.08|2-Sided||||||Regression, Cox||||
1718357|NCT00721734|3163787|Superiority or Other||Slope|-0.607||||0.4114|2-Sided|95.0|-2.129|0.914|||Regression, Linear|||"In order to estimate a possible effect of renal function, the relationship between the clearance of carfilzomib and creatinine clearance (CrCl) was explored using a mixed-effects model that included CrCl.~The slope of the regression of CL as a function of CrCL at Cycle 1, Day 1 was evaluated using a linear regression model that included CrCL as continuous variables (excluding the hemodialysis group)."|
1718358|NCT00721409|3163843|Superiority or Other (legacy)||Mean Difference (Final Values)|0.5||||0.4427|2-Sided|95.0|-0.7|1.6||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.|
1718359|NCT00721409|3163843|Superiority or Other (legacy)||Mean Difference (Final Values)|0.4||||0.563|2-Sided|95.0|-1.0|1.9||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Interference Scale.|
1718360|NCT00721409|3163843|Superiority or Other (legacy)||Mean Difference (Final Values)|0.4||||0.3346|2-Sided|95.0|-0.5|1.3||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Interference Scale.|
1718361|NCT00721409|3163844|Superiority or Other (legacy)||Mean Difference (Final Values)|0.5||||0.4012|2-Sided|95.0|-0.6|1.5||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.|
1718362|NCT00721409|3163844|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.3||||0.7125|2-Sided|95.0|-1.8|1.2||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.|
1718363|NCT00721409|3163844|Superiority or Other (legacy)||Mean Difference (Final Values)|0.2||||0.69|2-Sided|95.0|-0.7|1.0||P-values are based on 2-sample t-test.|t-test, 2 sided|||Statistical analysis presented above is for Pain Severity Scale.|
1718364|NCT00721409|3163845|Superiority or Other (legacy)||Hazard Ratio (HR)|0.486||||0.003|2-Sided|95.0|0.288|0.822||1-sided p-value is from unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above. Kaplan-Meier method was applied for median and 95% CI.|
1718365|NCT00721409|3163845|Superiority or Other (legacy)||Hazard Ratio (HR)|0.299|||<|0.0001|2-Sided|95.0|0.156|0.572||1-sided p-value is from unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above. Kaplan-Meier method was applied for median and 95% CI.|
1718366|NCT00721409|3163845|Superiority or Other (legacy)||Hazard Ratio (HR)|0.399|||<|0.0001|2-Sided|95.0|0.265|0.601||1-sided p-value is from the stratified log-rank test (α =0.10).|Log Rank|||Kaplan-Meier method was applied for median and 95% CI. Hazard ratio was based on assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of palbociclib + letrozole.|
1718367|NCT00721409|3163846|Superiority or Other (legacy)||Odds Ratio (OR)|2.55||||0.0442|2-Sided|95.0|0.89|7.7||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.|
1718368|NCT00721409|3163846|Superiority or Other (legacy)||Odds Ratio (OR)|4.18||||0.0065|2-Sided|95.0|1.3|13.9||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.|
1718369|NCT00721409|3163846|Superiority or Other (legacy)||Odds Ratio (OR)|3.18||||0.0009|2-Sided|95.0|1.48|6.98||1-sided p-value is from the stratified exact test (1-sided, α =0.10).|Cochran-Mantel-Haenszel|||CBR CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio >1 means better response in favor of palbociclib + letrozole arm.|
1718370|NCT00721409|3163848|Superiority or Other (legacy)||Odds Ratio (OR)|1.72||||0.1631|2-Sided|95.0|0.65|4.54||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.|
1718371|NCT00721409|3163848|Superiority or Other (legacy)||Odds Ratio (OR)|2.34||||0.118|2-Sided|95.0|0.65|8.66||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.|
1718372|NCT00721409|3163848|Superiority or Other (legacy)||Odds Ratio (OR)|1.93||||0.0471|2-Sided|95.0|0.91|4.08||1-sided p-value is from the stratified exact test (1-sided, α =0.10)|Cochran-Mantel-Haenszel|||Objective Response CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio >1 means better response in favor of palbociclib + letrozole arm.|
1718373|NCT00721409|3163849|Superiority or Other (legacy)||Odds Ratio (OR)|1.14||||0.4515|2-Sided|95.0|0.48|2.76||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.|
1718374|NCT00721409|3163849|Superiority or Other (legacy)||Odds Ratio (OR)|2.37||||0.0849|2-Sided|95.0|0.74|7.84||Chi-square test was used (1-sided, α=0.10)|Chi-squared|||Unstratified analysis was presented above. Exact CI was based on Clopper-Pearson method.|
1718375|NCT00721409|3163849|Superiority or Other (legacy)||Odds Ratio (OR)|1.5||||0.1347|2-Sided|95.0|0.76|2.97||1-sided p-value is from the stratified exact test (1-sided, α =0.10)|Cochran-Mantel-Haenszel|||Objective Response CI was calculated using the exact Clopper-Pearson method. The stratified analysis presented above was based on CMH test stratified by Part. An Odds Ratio >1 means better response in favor of palbociclib + letrozole arm.|
1718376|NCT00721409|3163850|Superiority or Other (legacy)||Hazard Ratio (HR)|0.935||||0.3875|2-Sided|95.0|0.59|1.48||1-sided p-value from the unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above.|
1718377|NCT00721409|3163850|Superiority or Other (legacy)||Hazard Ratio (HR)|0.837||||0.2803|2-Sided|95.0|0.458|1.527||1-sided p-value from the unstratified log-rank test (α=0.10).|Log Rank|||Unstratified analysis was presented above.|
1718378|NCT00721409|3163850|Superiority or Other (legacy)||Hazard Ratio (HR)|0.897||||0.2812|2-Sided|95.0|0.623|1.294||1-sided p-value from the log-rank test stratified by Part (α = 0.10).|Log Rank|||Stratified analysis was presented above. Hazard ratio was assuming proportional hazards, a hazard ratio less than 1 indicated a reduction in hazard rate in favor of palbociclib + letrozole.|
1718379|NCT00721409|3163863|Superiority or Other (legacy)||Hazard Ratio (HR)|0.508||||0.0046|2-Sided|95.0|0.303|0.853||1-sided p-value from the log-rank test.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Unstratified analysis was presented above.|
1718380|NCT00721409|3163863|Superiority or Other (legacy)||Hazard Ratio (HR)|0.299|||<|0.0001|2-Sided|95.0|0.156|0.572||1-sided p-value from the log-rank test.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Unstratified analysis was presented above.|
1718381|NCT00721409|3163863|Superiority or Other (legacy)||Hazard Ratio (HR)|0.488|||<|0.0004|2-Sided|95.0|0.319|0.748||1-sided p-value from the log-rank test stratified by stratification factors per randomization and Part.|Log Rank|||The primary hypothesis to be tested was H0: λ=1 versus. HA: λ<1, where λ was the palbociclib plus letrozole:letrozole alone hazard ratio (HR). A HR less than 1 indicates a reduction in hazard rate in favor of Palbociclib + Letrozole. Stratified analysis was presented above.|
1718382|NCT00721396|3163867|Non-Inferiority or Equivalence|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-1.0|||||2-Sided|95.0|-4.0|2.0||||||Non-inferiority of immune responses against Pertussis antigen PT when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.|
1718383|NCT00721396|3163867|Non-Inferiority or Equivalence|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-2.0|||||2-Sided|95.0|-7.0|2.0||||||Non-inferiority of immune responses against Pertussis antigen pertactin antigen when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.|
1718384|NCT00721396|3163867|Non-Inferiority or Equivalence|Group B+R234 was to be considered non-inferior to Group R234 if the 2-sided 95% lower confidence limit of this difference at 30 days after the last injection was greater than -10% for each of the antigens of the routine vaccinations.|Difference %(B+R234 minus R234)|-1.0|||||2-Sided|95.0|-5.0|4.0||||||Non-inferiority of immune responses against Pertussis antigen FHA when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.|
1718385|NCT00721396|3163872|Non-Inferiority or Equivalence|Immune response of Group B+R234 was considered non-inferior to response of Group R234, if at one month after the third injection the 2-sided 95% lower confidence limit for the difference in the percentage of subjects with antibody response greater than the pre-specified cut off of for tetanus toxoid (≥0.1 IU/mL) was >-10%.|Difference %(B+R234 minus R234)|0.0|||||2-Sided|95.0|-1.0|2.0||||||Non-inferiority of immune response to Tetanus antigens when routine vaccines are administered concomitantly with rMen+OMV NZ vaccine.|
1718386|NCT00721396|3163872|Non-Inferiority or Equivalence|Immune response of Group B+R234 was considered non-inferior to response of Group R234, if at one month after the third injection the 2-sided 95% lower confidence limit for the difference in the percentage of subjects with antibody response greater than the pre-specified cut off of for diphtheria (≥0.1 IU/mL) was >-10%.|Difference %(B+R234 minus R234)|0.0|||||2-Sided|95.0|-1.0|2.0||||||Non-inferiority of immune responses against Diphtheria antigen when routine vaccine was administered concomitantly with rMenB+OMV NZ vaccine to when only routine vaccines were administered.|
1718387|NCT00721396|3163873|Non-Inferiority or Equivalence|Immune response of Group B+R246 was considered non-inferior to response of Group B246_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence limit of the difference in the percentage of subjects with hSBA titer ≥5 was greater than -10% for each of the 3 strains.|Difference % (B+R246 minus B246_R357)|-8.0|||||2-Sided|95.0|-12.0|-4.0||||||Non-inferiority of immune responses against NZ98/254 strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.|
1718388|NCT00721396|3163873|Non-Inferiority or Equivalence|Immune response of Group B+R246 was considered non-inferior to response of Group B246_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence limit of the difference in the percentage of subjects with hSBA titer ≥5 was greater than -10% for each of the 3 strains.|Difference %(B+R246 minus B246_R357)|0.0|||||2-Sided|95.0|-1.0|1.0||||||Non-inferiority of immune responses against 5/99 strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.|
1718389|NCT00721396|3163873|Non-Inferiority or Equivalence|Immune response of Group B+R246 was considered non-inferior to response of Group B246_R357, if at one month after the third rMenB+OMV NZ injection the 2-sided 95% lower confidence interval of the difference in the percentage of subjects with hSBA titer ≥1:5 was greater than -10% for each of the 3 strains.|Difference % (B+R246 minus B246_R357)|0.0|||||2-Sided|95.0|-1.0|1.0||||||Non-inferiority of immune responses against 44/76-SL strain when rMenB+OMV NZ vaccine was administered concomitantly with routine infant vaccines as compared to when rMenB+OMV NZ vaccine and routine vaccines were given separately.|
1718390|NCT00721175|3163910|Superiority or Other||Mean Difference (Final Values)|-0.278744|Standard Error of the Mean|0.0929622||0.004|2-Sided|95.0|-0.4609466|-0.0965414|||Two-sample test of proportion||||
1718391|NCT00721175|3163912|Superiority or Other|||||||0.0021|||||||Log Rank||||
1718827|NCT00713609|3164944|Superiority or Other||||||<|0.255||||||For TC|ANCOVA||||
1718392|NCT00721175|3163913|Superiority or Other||Mean Difference (Final Values)|-0.2407407|Standard Error of the Mean|0.0920078||0.011|2-Sided|95.0|-0.4210726|-0.0604089|||Two-sample test of proportion||||
1718393|NCT00721136|3163928|Other|||||||||||||||||Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.|Continuous variables were expressed as mean ± standard deviation and analyzed using Student's t-test and Mann-Whitney U-test in cases of nonparametric distribution. Categorical variables were expressed as numbers or percentages and analyzed with two-tailed Fisher's exact test or χ2-test as appropriate. Data were analyzed on an intention-to-treat basis using STATA 10.1 (College Station, TX). A two-tailed alpha of 0.05 was considered statistically significant.
1718394|NCT00721110|3163942|Superiority or Other||Mean Difference (Final Values)|0.3||||0.59|2-Sided|97.5|-1.8|2.57||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine was compared to nonketamine on mean VRS fatigue score using a t test.|
1718395|NCT00721110|3163942|Superiority or Other||Mean Difference (Final Values)|0.03||||0.96|2-Sided|97.5|-2.14|2.2||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine was compared to nonlidocaine on mean VRS fatigue score using a t test.|
1718396|NCT00721110|3163943|Superiority or Other||Risk Ratio (RR)|0.07||||0.44|2-Sided|97.5|-0.22|0.38|||Chi-squared|||Ketamine versus nonketamine on postoperative day 1 vomiting assessed using Pearson chi square test.|
1718397|NCT00721110|3163943|Superiority or Other||Risk Ratio (RR)|0.06||||0.52|2-Sided|97.5|-0.23|0.36||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on postoperative day 1 vomiting assessed using a Pearson chi square test.|
1718398|NCT00721110|3163943|Superiority or Other||Risk Ratio (RR)|-0.06||||0.71|2-Sided|97.5|-0.31|0.19||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Ketamine versus nonketamine on PACU (postoperative care unit) vomiting assessed using a Pearson chi square test.|
1718399|NCT00721110|3163943|Superiority or Other||Risk Ratio (RR)|-0.13||||0.26|2-Sided|97.5|-0.38|0.12||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on PACU (postoperative care unit) vomiting assessed using Pearson chi square test.|
1718400|NCT00721110|3163943|Superiority or Other||Risk Ratio (RR)|0.03||||0.79|2-Sided|97.5|-0.34|0.41||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Ketamine versus nonketamine on POD 1(first postoperative day) nausea assessed using Pearson chi square test.|
1718401|NCT00721110|3163943|Superiority or Other||Risk Ratio (RR)|0.06||||0.61|2-Sided|97.5|-0.31|0.44||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared|||Lidocaine versus nonlidocaine on POD 1 (first postoperative day) nausea assessed using Pearson chi square test.|
1718402|NCT00721110|3163943|Superiority or Other||Risk Ratio (RR)|0.02||||0.87|2-Sided|97.5|-0.32|0.36||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared||Numinator: ketamine; denominator: nonketamine|Ketamine versus nonketamine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.|
1718403|NCT00721110|3163943|Superiority or Other||Risk Ratio (RR)|0.06||||0.58|2-Sided|97.5|-0.28|0.41||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Chi-squared||numerator: lidocaine; denominator: control|Lidocaine versus nonlidocaine on PACU (postoperative care unit) nausea assessed using Pearson chi square test.|
1718404|NCT00721110|3163944|Superiority or Other||Median Difference (Final Values)|0.0||||0.79|2-Sided|97.5|-5.0|8.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.|
1718405|NCT00721110|3163944|Superiority or Other||Median Difference (Final Values)|2.5||||0.3|2-Sided|97.5|-5.0|10.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative day 2 opioid consumption was assessed using a Wilcoxon rank sum test.|
1718406|NCT00721110|3163944|Superiority or Other||Median Difference (Final Values)|-3.0||||0.66|2-Sided|97.5|-19.0|14.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.|
1718407|NCT00721110|3163944|Superiority or Other||Median Difference (Final Values)|2.5||||0.76|2-Sided|97.5|-13.0|21.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative day 1 opioid consumption was assessed using a Wilcoxon rank sum test.|
1718423|NCT00720759|3163984|Superiority or Other||Slope|0.83|Standard Error of the Mean|8.54|<|0.05|2-Sided|95.0|||||Regression, Linear|||A general linear model was employed. The independent variables were baseline WMFT score, treatment (condensed vs distributed), treatment (d-cycloserine vs placebo), and treatment interaction effect. The dependent measure was WMFT score at 3 months post treatment.|
1718408|NCT00721110|3163944|Superiority or Other||Median Difference (Final Values)|-4.0||||0.22|2-Sided|97.5|-15.0|4.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.|
1718409|NCT00721110|3163944|Superiority or Other||Median Difference (Final Values)|-3.0||||0.28|2-Sided|97.5|-15.0|5.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on postoperative care unit opioid consumption was assessed using a Wilcoxon rank sum test.|
1718410|NCT00721110|3163944|Superiority or Other||Median Difference (Final Values)|-2.0||||0.27|2-Sided|97.5|-10.0|5.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Ketamine versus nonketamine on intraoperative opioid consumption was assessed using a Wilcoxon rank sum test.|
1718411|NCT00721110|3163944|Superiority or Other||Median Difference (Final Values)|0.0||||0.63|2-Sided|97.5|-7.0|7.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|Wilcoxon (Mann-Whitney)|||Lidocaine versus nonlidocaine on intraoperative opioid consumption was assessed using the Wilcoxon rank sum test.|
1718412|NCT00721110|3163945|Superiority or Other||Mean Difference (Final Values)|0.3||||0.47|2-Sided|97.5|-1.1|1.8||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative day 2 pain severity was assessed using a t test.|
1718413|NCT00721110|3163945|Superiority or Other||Mean Difference (Final Values)|0.3||||0.55|2-Sided|97.5|-1.1|1.7||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on postoperative day 2 pain severity was assessed using a t test.|
1718414|NCT00721110|3163945|Superiority or Other||Mean Difference (Final Values)|0.1||||0.79|2-Sided|97.5|-1.4|1.7||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative day 1 pain severity was assessed using a t test.|
1718415|NCT00721110|3163945|Superiority or Other||Median Difference (Final Values)|0.6||||0.2|2-Sided|97.5|-0.9|2.2||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on postoperative day 1 pain severity assessed using a t test.|
1718416|NCT00721110|3163945|Superiority or Other||Mean Difference (Final Values)|0.3||||0.56|2-Sided|97.5|-1.4|2.0||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine versus nonketamine on postoperative care unit discharge pain severity was assessed using a t test.|
1718417|NCT00721110|3163945|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.11|2-Sided|97.5|-2.5|0.8||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Lidocaine versus nonlidocaine on pain severity at postoperative care unit discharge was assessed using a t test.|
1718418|NCT00721110|3163945|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.54|2-Sided|97.5|-2.8|1.9||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Ketamine compared to placebo at PACU admit using a t test|
1718419|NCT00721110|3163945|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.2|2-Sided|97.5|-3.3|1.3||97.5% confidence intervals (CIs) adjusted for group sequential design (using confidence coefficient of 2.97) to maintain the overall α of 0.025 for each intervention and 0.05 for the trial.|t-test, 2 sided|||Groups compared on VRS scores at PACU admit using a t test.|
1718420|NCT00721110|3163946|Superiority or Other||Mean Difference (Final Values)|-11.0||||0.54|2-Sided|97.5|-65.0|44.0||97.5% confidence interval adjusted for group sequential design (using confidence coefficient of 2.97) to maintain theoverall α of 0.025 for each primary intervention and 0.05 for the trial.|ANCOVA|Adjusted for baseline 6-minute walk distance||The effect of ketamine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.|
1718421|NCT00721110|3163946|Superiority or Other||Mean Difference (Final Values)|0.93||||0.96|2-Sided|97.5|-52.0|54.0||Significant if P < 0.003 for efficacy and P > 0.5311 for futility; 97.5% confidence intervals adjusted for group sequential design to maintain the overall alpha of 0.025 for each primary intervention.|ANCOVA|Adjusted for baseline 6-minute walk distance||The effect of lidocaine on 6-minute walk distance on the 2nd postoperative morning was assessed using analysis of covariance. We expected the control group's mean 6-minute walk distance to be 300 meters with a standard deviation (SD) of about 20% of the mean for each group. Assuming a correlation of 0.5 between baseline and 2nd postoperative day, a maximum 128 total patients (32 for each group) was needed to have 80% power at the 0.025 significance level to detect effects of 36 meters or more.|
1718422|NCT00720941|3163964|Non-Inferiority or Equivalence (legacy)|Non-inferiority is defined as excluding a difference of greater than 25% in the hazards. The upper limit of the 95% confidence interval must be <1.25.|Hazard Ratio (HR)|1.0466|||||2-Sided|95.0|0.8982|1.2195|||||The HR is estimated by the Cox regression model using treatment stratification factors as covariates. The HR is adjusted for Karnofsky Performance Scale scores, prior nephrectomy, and Baseline levels of lactate dehydrogenase (<=1.5xULN, >1.5xULN).||
1718424|NCT00720499|3164000|Superiority or Other||Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.08||0.8096|2-Sided|95.0|-0.178|0.14|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718425|NCT00720499|3164000|Superiority or Other||Mean Difference (Final Values)|-0.005|Standard Error of the Mean|0.089||0.9557|2-Sided|95.0|-0.181|0.171|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718426|NCT00720499|3164001|Superiority or Other||Mean Difference (Final Values)|-0.114|Standard Error of the Mean|0.116||0.3269|2-Sided|95.0|-0.342|0.115|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for treatment, centre, patient within centre and period (all effects fixed).|
1718427|NCT00720499|3164002|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.09||0.6542|2-Sided|95.0|-0.218|0.137|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718428|NCT00720499|3164002|Superiority or Other||Mean Difference (Final Values)|-0.002|Standard Error of the Mean|0.09||0.9822|2-Sided|95.0|-0.18|0.176|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718429|NCT00720499|3164002|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.086||0.1647|2-Sided|95.0|-0.29|0.05|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718430|NCT00720499|3164002|Superiority or Other||Mean Difference (Final Values)|0.011|Standard Error of the Mean|0.08||0.8901|2-Sided|95.0|-0.147|0.169|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718431|NCT00720499|3164003|Superiority or Other||Mean Difference (Final Values)|-1.039|Standard Error of the Mean|2.478||0.6757|2-Sided|95.0|-5.944|3.865|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718432|NCT00720499|3164003|Superiority or Other||Mean Difference (Final Values)|1.695|Standard Error of the Mean|2.498||0.4988|2-Sided|95.0|-3.251|6.64|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718433|NCT00720499|3164003|Superiority or Other||Mean Difference (Final Values)|1.393|Standard Error of the Mean|2.738||0.6118|2-Sided|95.0|-4.027|6.813|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718434|NCT00720499|3164003|Superiority or Other||Mean Difference (Final Values)|3.303|Standard Error of the Mean|2.585||0.2037|2-Sided|95.0|-1.813|8.418|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718435|NCT00720499|3164004|Superiority or Other||Mean Difference (Final Values)|1.654|Standard Error of the Mean|2.543||0.5166|2-Sided|95.0|-3.379|6.686|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 4. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718436|NCT00720499|3164004|Superiority or Other||Mean Difference (Final Values)|0.653|Standard Error of the Mean|2.294||0.7765|2-Sided|95.0|-3.888|5.194|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 3. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718437|NCT00720499|3164004|Superiority or Other||Mean Difference (Final Values)|1.339|Standard Error of the Mean|2.342||0.5686|2-Sided|95.0|-3.296|5.973|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Week 2. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718438|NCT00720499|3164004|Superiority or Other||Mean Difference (Final Values)|1.119|Standard Error of the Mean|2.177||0.6081|2-Sided|95.0|-3.19|5.429|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test week 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718439|NCT00720499|3164005|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|4.655||0.8808|2-Sided|95.0|-9.914|8.514|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718440|NCT00720499|3164006|Superiority or Other||Mean Difference (Final Values)|3.099|Standard Error of the Mean|3.134||0.3245|2-Sided|95.0|-3.1|9.298|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718441|NCT00720499|3164006|Superiority or Other||Mean Difference (Final Values)|6.48|Standard Error of the Mean|3.559||0.0709|2-Sided|95.0|-0.56|13.52|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718442|NCT00720499|3164006|Superiority or Other||Mean Difference (Final Values)|-0.179|Standard Error of the Mean|2.342||0.9391|2-Sided|95.0|-4.812|4.454|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718443|NCT00720499|3164007|Superiority or Other||Mean Difference (Final Values)|1.552|Standard Error of the Mean|2.67||0.562|2-Sided|95.0|-3.729|6.833|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718444|NCT00720499|3164007|Superiority or Other||Mean Difference (Final Values)|6.311|Standard Error of the Mean|3.156||0.0475|2-Sided|95.0|0.07|12.553|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718445|NCT00720499|3164007|Superiority or Other||Mean Difference (Final Values)|0.984|Standard Error of the Mean|2.038||0.6299|2-Sided|95.0|-3.046|5.015|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718446|NCT00720499|3164008|Superiority or Other||Mean Difference (Final Values)|0.046|Standard Error of the Mean|0.043||0.2875|2-Sided|95.0|-0.039|0.13|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718447|NCT00720499|3164009|Superiority or Other||Mean Difference (Final Values)|0.035|Standard Error of the Mean|0.03||0.2485|2-Sided|95.0|-0.024|0.094|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718448|NCT00720499|3164010|Superiority or Other||Mean Difference (Final Values)|0.029|Standard Error of the Mean|0.027||0.2914|2-Sided|95.0|-0.025|0.082|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718449|NCT00720499|3164010|Superiority or Other||Mean Difference (Final Values)|0.037|Standard Error of the Mean|0.026||0.1583|2-Sided|95.0|-0.014|0.088|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718450|NCT00720499|3164010|Superiority or Other||Mean Difference (Final Values)|0.001|Standard Error of the Mean|0.015||0.9384|2-Sided|95.0|-0.029|0.032|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)|
1718451|NCT00720499|3164012|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.028||0.718|2-Sided|95.0|-0.046|0.066|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718452|NCT00720499|3164012|Superiority or Other||Mean Difference (Final Values)|0.032|Standard Error of the Mean|0.031||0.2944|2-Sided|95.0|-0.029|0.094|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718453|NCT00720499|3164013|Superiority or Other||Mean Difference (Final Values)|0.007|Standard Error of the Mean|0.038||0.8473|2-Sided|95.0|-0.067|0.082|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718454|NCT00720499|3164014|Superiority or Other||Mean Difference (Final Values)|0.004|Standard Error of the Mean|0.015||0.7906|2-Sided|95.0|-0.026|0.034|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718455|NCT00720499|3164015|Superiority or Other||Mean Difference (Final Values)|0.007|Standard Error of the Mean|0.018||0.7139|2-Sided|95.0|-0.029|0.042|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)|
1718456|NCT00720499|3164015|Superiority or Other||Mean Difference (Final Values)|0.022|Standard Error of the Mean|0.019||0.2408|2-Sided|95.0|-0.015|0.058|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)|
1718457|NCT00720499|3164015|Superiority or Other||Mean Difference (Final Values)|-0.007|Standard Error of the Mean|0.01||0.5339|2-Sided|95.0|-0.027|0.014|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)|
1718458|NCT00720499|3164016|Superiority or Other||Mean Difference (Final Values)|-0.001|Standard Error of the Mean|0.014||0.9368|2-Sided|95.0|-0.029|0.027|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test day 29. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)|
1718459|NCT00720499|3164016|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.016||0.211|2-Sided|95.0|-0.011|0.051|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 15. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed)|
1718460|NCT00720499|3164016|Superiority or Other||Mean Difference (Final Values)|0.005|Standard Error of the Mean|0.008||0.5198|2-Sided|95.0|-0.01|0.021|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Test Day 1. Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718461|NCT00720499|3164018|Superiority or Other||Mean Difference (Final Values)|0.023|Standard Error of the Mean|0.019||0.2425|2-Sided|95.0|-0.015|0.061|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718462|NCT00720499|3164019|Superiority or Other||Mean Difference (Final Values)|-0.002|Standard Error of the Mean|0.017||0.8937|2-Sided|95.0|-0.035|0.031|||ANCOVA||Difference calculated as Olo 5 µg + Tio 5 µg minus Olo 2 µg + Tio 5 µg|Based on a ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).|
1718463|NCT00720434|3164032|Superiority or Other||Adjusted Mean Difference|0.12833||||0.8891|2-Sided|95.0|-1.73676|1.99342|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.|
1718572|NCT00718549|3164324|Superiority||Odds Ratio (OR)|0.844||||0.826|2-Sided|95.0|0.161|3.681|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes|
1718464|NCT00720434|3164032|Superiority or Other||Adjusted Mean Difference|-1.02865||||0.2839|2-Sided|95.0|-2.95573|0.89844|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.|
1718465|NCT00720434|3164032|Superiority or Other||Adjusted Mean Difference|-0.90032||||0.3321|2-Sided|95.0|-2.76711|0.96648|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.|
1718466|NCT00720434|3164032|Superiority or Other||Adjusted Mean Difference|-1.46325||||0.1368|2-Sided|95.0|-3.41898|0.49248|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.|
1718467|NCT00720434|3164032|Superiority or Other||Adjusted Mean Difference|-2.4919||||0.0142|2-Sided|95.0|-4.44619|-0.5376|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.|
1718468|NCT00720434|3164032|Superiority or Other||Adjusted Mean Difference|-2.36357||||0.0131|2-Sided|95.0|-4.19228|-0.53485|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.|
1718469|NCT00720434|3164035|Superiority or Other||Difference in Proportions|-0.2|||||2-Sided|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718470|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.0|||||2-Sided|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718471|NCT00720434|3164035|Superiority or Other||Difference in Proportions|-0.2|||||2-Sided|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718472|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.0|||||2-Sided|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718473|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.0|||||2-Sided|95.0|-0.507|0.507||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718474|NCT00720434|3164035|Superiority or Other||Difference in Proportions|-0.2|||||2-Sided|95.0|-0.6191|0.2811||||||Week 72: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718475|NCT00720434|3164035|Superiority or Other||Difference in Proportions|-0.2|||||2-Sided|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718476|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.0|||||2-Sided|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718477|NCT00720434|3164035|Superiority or Other||Difference in Proportions|-0.2|||||2-Sided|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718478|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.0|||||2-Sided|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718479|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.0|||||2-Sided|95.0|-0.507|0.507||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718480|NCT00720434|3164035|Superiority or Other||Difference in Proportions|-0.2|||||2-Sided|95.0|-0.6191|0.2811||||||Week 60: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718481|NCT00720434|3164035|Superiority or Other||Difference in Proportions|-0.15|||||2-Sided|95.0|-0.5729|0.3149||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718482|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.125|||||2-Sided|95.0|-0.4024|0.6049||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718483|NCT00720434|3164035|Superiority or Other||Difference in Proportions|-0.025||||||95.0|-0.4769|0.4336||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718484|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.125|||||2-Sided|95.0|-0.4024|0.6049||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718485|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.25|||||2-Sided|95.0|-0.2913|0.696||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718486|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.1|||||2-Sided|95.0|-0.3728|0.5414||||||Week 48: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718487|NCT00720434|3164035|Superiority or Other||Difference in Proportions|-0.075|||||2-Sided|95.0|-0.5144|0.388||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718573|NCT00718549|3164324|Superiority||Odds Ratio (OR)|4.2||||0.233|2-Sided|95.0|0.484|89.588|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive|
1718488|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.25|||||2-Sided|95.0|-0.2913|0.696||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718489|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.175|||||2-Sided|95.0|-0.2934|0.5917||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718490|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.125|||||2-Sided|95.0|-0.4024|0.6049||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718491|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.375|||||2-Sided|95.0|-0.1732|0.7797||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718492|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.3|||||2-Sided|95.0|-0.1836|0.6931||||||Week 12: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718493|NCT00720434|3164035|Superiority or Other||Difference in Proportions|-0.15|||||2-Sided|95.0|-0.5729|0.3149||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718494|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.125||||||95.0|-0.4024|0.6049||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718495|NCT00720434|3164035|Superiority or Other||Difference in Proportions|-0.025|||||2-Sided|95.0|-0.4769|0.4336||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718496|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.625|||||2-Sided|95.0|0.0871|0.9191||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718497|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.75|||||2-Sided|95.0|0.233|0.969||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718498|NCT00720434|3164035|Superiority or Other||Difference in Proportions|0.6|||||2-Sided|95.0|0.1565|0.8785||||||Week 4: The difference in proportions between treatment groups presented along with 95% CI, were based on exact method for small samples from the binomial distribution.|
1718499|NCT00720434|3164036|Superiority or Other||Adjusted Mean Difference|0.12833||||0.8891|2-Sided|95.0|-1.73676|1.99342|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.|
1718500|NCT00720434|3164036|Superiority or Other||Adjusted Mean Difference|-1.02865||||0.2839|2-Sided|95.0|-2.95573|0.89844|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.|
1718501|NCT00720434|3164036|Superiority or Other||Adjusted Mean Difference|-0.90032||||0.3321|2-Sided|95.0|-2.76711|0.96648|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.|
1718502|NCT00720434|3164036|Superiority or Other||Adjusted Mean Difference|-1.46325||||0.1368|2-Sided|95.0|-3.41898|0.49248|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.|
1718503|NCT00720434|3164036|Superiority or Other||Adjusted Mean Difference|-2.4919||||0.0142|2-Sided|95.0|-4.44619|-0.5376|||ANCOVA|||An ANCOVA model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95% CI were calculated.|
1718504|NCT00720434|3164036|Superiority or Other||Adjusted Mean Difference|-2.36357||||0.0131|2-Sided|95.0|-4.19228|-0.53485|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to compare differences among treatments. Independent variables included treatment and log-transformed baseline HCV viral load. Adjusted mean difference and corresponding 95 percentage (%) confidence interval (CI) were calculated.|
1718505|NCT00720382|3164037|Superiority or Other|||||||0.037|||||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from Baseline to Month 12/Early Term|
1718506|NCT00720382|3164037|Superiority or Other|||||||0.181|||||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 9|
1718507|NCT00720382|3164037|Superiority or Other|||||||0.111|||||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 6|
1718508|NCT00720382|3164037|Superiority or Other|||||||0.206|||||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 3|
1718509|NCT00720382|3164037|Superiority or Other|||||||0.971|||||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Change from baseline to Month 1|
1718510|NCT00720382|3164037|Superiority or Other|||||||0.783|||||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate||Overall baseline score|
1718511|NCT00720278|3164063|Superiority or Other||Mean Difference (Final Values)|-2.432|Standard Deviation|0.4145|<|0.001||95.0|-3.24|-1.62|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14|
1718512|NCT00720278|3164063|Superiority or Other||Mean Difference (Final Values)|-1.376|Standard Deviation|0.418|<|0.001||95.0|-2.2|-0.56|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14|
1718513|NCT00720278|3164064|Superiority or Other||Mean Difference (Final Values)|-2.668|Standard Deviation|0.4735|<|0.001||95.0|-3.6|-1.74|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14|
1718514|NCT00720278|3164064|Superiority or Other||Mean Difference (Final Values)|-1.78|Standard Deviation|0.479|<|0.001||95.0|-2.72|-0.84|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14|
1718515|NCT00720278|3164065|Superiority or Other||Mean Difference (Final Values)|-3.0|Standard Deviation|0.465|<|0.001||95.0|-3.91|-2.09|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14|
1718516|NCT00720278|3164065|Superiority or Other||Mean Difference (Final Values)|-2.06|Standard Deviation|0.47|<|0.001||95.0|-2.98|-1.14|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 14|
1718517|NCT00720226|3164066|Superiority|||||||0.55|||||||t-test, 2 sided|||Participants with 5-35% emphysema at baseline|
1718518|NCT00720226|3164067|Superiority|||||||0.06|||||||t-test, 2 sided|||Participants demonstrating 5-35% emphysema on baseline CT scan|
1718519|NCT00720213|3164084|Superiority or Other||Mean Difference (Final Values)|3.98|Standard Deviation|8.03||0.0054|2-Sided|95.0|1.44|6.51|||Wilcoxon Signed Rank test|||Each participant was treated with the BiPAP autoSV2 (ASV2) and autoSV Advanced (ASV3) on two separate nights; therefore, the data were analyzed as paired samples. Depending on normality, each endpoint was analyzed with either a paired t-test or the nonparametric Wilcoxon Signed Ranks test. All comparisons were 2-sided conducted at a 5% level of significance.|
1718520|NCT00720122|3164085|Superiority or Other||Mean Difference (Final Values)|-0.00558|Standard Error of the Mean|0.00653||0.4|2-Sided|95.0|-0.0081|0.0193|||Paired t-test|||A paired t-test was performed. The null hypothesis was that bone density would decrease over 6 months in females with anorexia nervosa, as observed in life course studies.|
1718521|NCT00720109|3164087|Superiority or Other (legacy)||percentage|10.5|||=|0|2-Sided|90.0|5.3|19.3|||Binomial Test||The pre-specified threshold for the estimated percentage of MRD positivity at End Consolidation was set to 16%. Results show an upper bound on the (Agresti-Coull) confidence interval of 19.3%.||
1718522|NCT00720109|3164088|Superiority or Other (legacy)||Percentage|40.7|||<|0.001|2-Sided|90.0|30.8|51.4|||Chi-squared|Chi-squared test equivalent to Z-test of proportions.||The a priori plan was to compare MRD positivity rate with that on a prior study, AALL0031 (n=72 Cohorts 1-5 of AALL0031 with 71% MRD positive). Out of 59 patients with end-Induction MRD on AALL0622, 40.7% were MRD positive. Per protocol, rates will be compared with a 2 sample Z-test of proportions, 1-sided test, alpha=5%.|
1718523|NCT00720057|3164095|Superiority or Other||||||<|0.001|||||||Log Rank||||
1718524|NCT00720057|3164096|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1718525|NCT00720057|3164097|Superiority or Other||||||<|0.001|||||||Log Rank|||The statistics are from the Kaplan-Meier method. The median for naproxen treatment arm was not estimable from Kaplan-Meier method, therefore it is presented as the maximum value from the full range.|
1718526|NCT00720057|3164098|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1718527|NCT00720057|3164099|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1718528|NCT00720057|3164100|Superiority or Other||||||<|0.001|||||||ANCOVA|||The treatment differences between the two groups were tested each at the 5% two-sided significant level using a hierarchal testing procedure to control the overall type 1 error. SPID16-24 was eligible for testing only after a statistically significant difference between the two arms with respect to SPID0-24 was observed. The SPIDs were analyzed via ANCOVA model with treatment and trial site as fixed effects and baseline pain intensity score as the covariate.|
1718529|NCT00719862|3164111|Superiority or Other|||||||0.051|||||||ANOVA|||Change from baseline|
1718530|NCT00719862|3164112|Superiority or Other||Mean Difference (Final Values)|-0.7395|Standard Deviation|0.3305||0.025||95.0|-1.39|-0.09|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline|
1718531|NCT00719862|3164113|Superiority or Other||Mean Difference (Final Values)|-0.8617|Standard Deviation|0.3803||0.023||95.0|-1.61|-0.12|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.|||
1718532|NCT00719862|3164114|Superiority or Other||Median Difference (Final Values)|-0.2987|Standard Deviation|0.1881||0.112||95.0|-0.67|0.07|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.|||
1718533|NCT00719862|3164115|Superiority or Other||Mean Difference (Final Values)|-1.05|Standard Deviation|0.3782||0.005||95.0|-1.8|-0.31|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.|||
1718534|NCT00719615|3164157|Superiority or Other||||||<|0.05||||||Only risk factors significant at the 0.10 level in univariate analysis were included in the multivariate model.|Fisher Exact|||Patient characteristics for each group were assessed using descriptive statistics, including medians, range, frequencies, and proportions. Categorical outcomes were compared between the 3 groups using a Fisher's exact test. A logistic regression modeling procedure was used to compare the odds of a low vitamin D levels between patient groups while adjusting for other risk factors: gender, age, BMI, season, and TNM staging.|
1718535|NCT00719576|3164159|Superiority||||||<|0.001||||||KOOS other symptoms p-value <0.001|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.|
1718536|NCT00719576|3164159|Superiority||||||<|0.029||||||KOOS knee-related quality of life p-value 0.029|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.|
1718537|NCT00719576|3164159|Superiority||||||<|0.001||||||KOOS activities of daily living p-value <0.001|ANCOVA|||Analysis of covariance was conducted with treatment and center as fixed effects and Baseline subscale as covariate, conducted at α = 0.05 level of significance. Last observation carried forward was used for missing data imputation.|
1718574|NCT00718549|3164324|Superiority||Odds Ratio (OR)|4.0||||0.097|2-Sided|95.0|0.901|28.158|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin >/= Median Value versus Beta-2-Microglobulin <Median Value|
1718538|NCT00719576|3164161|Superiority|||||||0.016||||||KOOS Response Rate: a participant is regarded as a responder for KOOS if a 10-point improvement in both KOOS Pain and Function (SRA) scores was achieved with respect to Baseline. Otherwise, the patient is regarded as a nonresponder.|Cochran-Mantel-Haenszel|p-value was calculated for response categories ‘Responded’ and ‘Not responded’ using a Cochran-Mantel-Haenszel χ2 Test stratified by Center||Differences between groups were tested by the Cochran-Mantel-Haenszel chi-squared test stratified by center for responders.|
1718539|NCT00719576|3164162|Superiority|||||||0.92|||||||Cochran-Mantel-Haenszel|Cochran-Mantel Haenszel Row Mean Score Chi-Square||Differences between groups were tested by the Cochran-Mantel-Haenszel row mean score chi-squared test for defect fill.|
1718540|NCT00719576|3164163|Superiority or Other (legacy)|||||||0.717||||||Differences between groups were tested using analysis of variance|ANOVA|ANOVA with terms for treatment and center|||
1718541|NCT00719576|3164164|Superiority|The Wilks lambda test statistic and associated single P value from the MANOVA model were used to test the statistical significance of the difference in the co–primary endpoint between MACI and microfracture.||||||0.001|||||||MANOVA|||The changes from Baseline to Week 104 in KOOS Pain and Function (SRA) scores (co-primary efficacy parameter) were analyzed with a multivariate analysis of variance (MANOVA) model, with the last observation carried forward (LOCF) method for handling missing data. Terms included in the model are treatment and center as class variables and baseline KOOS pain and Function (SRA) as continuous covariates.|
1718542|NCT00719563|3164177|Superiority or Other|||||||0.0737|||||||Wilcoxon Rank Sum||||
1718543|NCT00719355|3164185|Superiority or Other||Mean Difference (Final Values)|1.4|Standard Deviation|3.65||0.109||95.0|||||ANCOVA|Repeated measures ANCOVA was used with intent to treat analysis. The co-variant was age.|||
1718544|NCT00719355|3164186|Superiority or Other||Mean Difference (Final Values)|6.25|Standard Deviation|14.4||0.033|2-Sided|95.0||||A priori level of significance was set at p <0.05.|ANCOVA|Repeated-measures ANCOVA using intent-to-treat procedures, was used for the primary outcome variable. Analyses were adjusted for age.||Observed power for our primary analysis was 0.64.|
1718545|NCT00719329|3164187|Superiority or Other||Prevalence Rate Ratio|0.57|||||2-Sided|95.0|0.53|0.63|||||Prevalence Ratio Ratio - Comparing Multiple Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group|
1718546|NCT00719329|3164187|Superiority or Other||Prevalence Rate Ratio|0.92|||||2-Sided|95.0|0.89|0.96|||||Prevalence Rate Ratio - Comparing Single Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group|
1718547|NCT00719329|3164188|Superiority or Other||Prevalence Rate Ratio|0.61|||||2-Sided|95.0|0.57|0.65|||||Prevalence Rate Ratio - Comparing Multiple Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group|
1718548|NCT00719329|3164188|Superiority or Other||Prevalence Rate Ratio|0.78|||||2-Sided|95.0|0.74|0.82|||||Prevalence Ratio Ratio - Comparing Single Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group|
1718549|NCT00719329|3164189|Superiority or Other||Prevalence Rate Ratio|0.71|||||2-Sided|95.0|0.66|0.77|||||Prevalence Rate Ratio - Comparing Multiple CHX Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group|
1718550|NCT00719329|3164189|Superiority or Other||Prevalence Rate Ratio|0.75|||||2-Sided|95.0|0.7|0.81|||||Prevalence Rate Ratio - Comparing Single CHX Cleansing to Dry Cord Care|Comparison of colonization prevalence, relative to dry cord care group|
1718551|NCT00719186|3164209|Superiority or Other|||||||0.007|||||||Chi-squared||||
1718552|NCT00718718|3164275|Superiority or Other|||||||0.148|||||||Cochran-Mantel-Haenszel||||
1718553|NCT00718718|3164276|Superiority or Other||||||<|0.001|||||||Van Der Waerden ANOVA||||
1718554|NCT00718718|3164276|Superiority or Other||||||<|0.001|||||||Van Der Waerden ANOVA||||
1718555|NCT00718718|3164276|Superiority or Other||||||<|0.001|||||||Van Der Waerden ANOVA||||
1718556|NCT00718718|3164276|Superiority or Other||||||<|0.001|||||||Van Der Waerden ANOVA||||
1718557|NCT00718718|3164276|Superiority or Other||||||<|0.001|||||||Van Der Waerden ANOVA||||
1718558|NCT00718718|3164277|Superiority or Other|||||||0.104|||||||Cochran-Mantel-Haenszel||||
1718559|NCT00718718|3164277|Superiority or Other|||||||0.026|||||||Cochran-Mantel-Haenszel||||
1718560|NCT00718718|3164277|Superiority or Other|||||||0.052|||||||Cochran-Mantel-Haenszel||||
1718561|NCT00718718|3164277|Superiority or Other|||||||0.026|||||||Cochran-Mantel-Haenszel||||
1718562|NCT00718549|3164323|Superiority||Odds Ratio (OR)|1.0||||1|2-Sided|95.0|0.099|22.791|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV|
1718563|NCT00718549|3164323|Superiority||Odds Ratio (OR)|1.0||||1|2-Sided|95.0|0.076|24.621|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes|
1718564|NCT00718549|3164323|Superiority||Odds Ratio (OR)|1.5||||0.691|2-Sided|95.0|0.212|13.563|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes|
1718565|NCT00718549|3164323|Superiority||Odds Ratio (OR)|0.667||||0.691|2-Sided|95.0|0.074|4.722|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes|
1718566|NCT00718549|3164323|Superiority||Odds Ratio (OR)|2.333||||0.486|2-Sided|95.0|0.201|29.008|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive|
1718567|NCT00718549|3164323|Superiority||Odds Ratio (OR)|3.2||||0.338|2-Sided|95.0|0.375|69.479|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin >/= Median Value versus Beta-2-Microglobulin <Median Value|
1718568|NCT00718549|3164323|Superiority||Odds Ratio (OR)|1.3||||0.796|2-Sided|95.0|0.147|9.222|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male|
1718569|NCT00718549|3164323|Superiority||Odds Ratio (OR)|1.923||||0.591|2-Sided|95.0|0.225|41.751|||Regression, Logistic|||Univariate Comparison: Age <60 years versus Age >/=60 years|
1718570|NCT00718549|3164324|Superiority||Odds Ratio (OR)|0.727||||0.794|2-Sided|95.0|0.08|15.779|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes|
1718571|NCT00718549|3164324|Superiority||Odds Ratio (OR)|1.067||||0.933|2-Sided|95.0|0.246|5.581|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes|
1718828|NCT00713609|3164944|Superiority or Other||||||<|0.149||||||For TC|ANCOVA||||
1718575|NCT00718549|3164324|Superiority||Odds Ratio (OR)|0.694||||0.623|2-Sided|95.0|0.138|2.8|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male|
1718576|NCT00718549|3164324|Superiority||Odds Ratio (OR)|0.528||||0.357|2-Sided|95.0|0.131|2.114|||Regression, Logistic|||Univariate Comparison: Age <60 years versus Age >/=60 years|
1718577|NCT00718549|3164325|Superiority||Odds Ratio (OR)|0.75||||0.776|2-Sided|95.0|0.103|6.572|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes|
1718578|NCT00718549|3164325|Superiority||Odds Ratio (OR)|0.361||||0.396|2-Sided|95.0|0.017|2.971|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes|
1718579|NCT00718549|3164325|Superiority||Odds Ratio (OR)|0.154||||0.216|2-Sided|95.0|0.005|4.405|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 17p No versus Yes|
1718580|NCT00718549|3164325|Superiority||Odds Ratio (OR)|0.857||||0.882|2-Sided|95.0|0.093|6.636|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive|
1718581|NCT00718549|3164325|Superiority||Odds Ratio (OR)|1.0||||1|2-Sided|95.0|0.164|8.102|||Regression, Logistic|||Univariate Comparison: ZAP-70 Expression Negative versus Positive|
1718582|NCT00718549|3164325|Superiority||Odds Ratio (OR)|0.635||||0.595|2-Sided|95.0|0.117|3.73|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin >/= Median Value versus Beta-2-Microglobulin <Median Value|
1718583|NCT00718549|3164325|Superiority||Odds Ratio (OR)|1.68||||0.655|2-Sided|95.0|0.229|34.486|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV|
1718584|NCT00718549|3164325|Superiority||Odds Ratio (OR)|0.667||||0.657|2-Sided|95.0|0.086|3.653|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male|
1718585|NCT00718549|3164325|Superiority||Odds Ratio (OR)|1.31||||0.768|2-Sided|95.0|0.237|10.189|||Regression, Logistic|||Univariate Comparison: Age <60 years versus Age >/=60 years|
1718586|NCT00718549|3164326|Superiority||Odds Ratio (OR)|0.957||||0.961|2-Sided|95.0|0.173|7.275|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 12q No versus Yes|
1718587|NCT00718549|3164326|Superiority||Odds Ratio (OR)|1.668||||0.375|2-Sided|95.0|0.566|5.649|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 11q No versus Yes|
1718588|NCT00718549|3164326|Superiority||Odds Ratio (OR)|1.88||||0.199|2-Sided|95.0|0.719|5.012|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 13q No versus Yes|
1718589|NCT00718549|3164326|Superiority||Odds Ratio (OR)|0.932||||0.936|2-Sided|95.0|0.186|6.839|||Regression, Logistic|||Univariate Comparison: Cytogenetic abnormality 17p No versus Yes|
1718590|NCT00718549|3164326|Superiority||Odds Ratio (OR)|0.921||||0.887|2-Sided|95.0|0.287|2.851|||Regression, Logistic|||Univariate Comparison: CD38 Expression Negative versus Positive|
1718591|NCT00718549|3164326|Superiority||Odds Ratio (OR)|8.809||||0.04|2-Sided|95.0|1.655|163.316|||Regression, Logistic|||Univariate Comparison: ZAP-70 Expression Negative versus Positive|
1718592|NCT00718549|3164326|Superiority||Odds Ratio (OR)|0.374||||0.045|2-Sided|95.0|0.137|0.957|||Regression, Logistic|||Univariate Comparison: Beta-2-Microglobulin >/= Median Value versus Beta-2-Microglobulin <Median Value|
1718593|NCT00718549|3164326|Superiority||Odds Ratio (OR)|0.465||||0.121|2-Sided|95.0|0.177|1.242|||Regression, Logistic|||Univariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV|
1718594|NCT00718549|3164326|Superiority||Odds Ratio (OR)|0.552||||0.26|2-Sided|95.0|0.183|1.488|||Regression, Logistic|||Univariate Comparison: Sex: Female versus Male|
1718595|NCT00718549|3164326|Superiority||Odds Ratio (OR)|0.982||||0.969|2-Sided|95.0|0.393|2.531|||Regression, Logistic|||Univariate Comparison: Age <60 years versus Age >/=60 years|
1718596|NCT00718549|3164327|Superiority||Hazard Ratio (HR)|0.288||||0.397|2-Sided|95.0|0.016|5.122|||Cox’s proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 12q No versus Yes|
1718597|NCT00718549|3164327|Superiority||Hazard Ratio (HR)|2.621||||0.463|2-Sided|95.0|0.2|34.422|||Cox’s proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 11q No versus Yes|
1718598|NCT00718549|3164327|Superiority||Hazard Ratio (HR)|0.438||||0.733|2-Sided|95.0|0.004|50.334|||Cox’s proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 13q No versus Yes|
1718599|NCT00718549|3164327|Superiority||Hazard Ratio (HR)|8.373||||0.426|2-Sided|95.0|0.045|1568.717|||Cox’s proportional hazards model|||Multivariate Comparison: Cytogenetic abnormality 17p No versus Yes|
1718600|NCT00718549|3164327|Superiority||Hazard Ratio (HR)|0.197||||0.134|2-Sided|95.0|0.024|1.647|||Cox’s proportional hazards model|||Multivariate Comparison: CD38 Expression Negative versus Positive|
1718601|NCT00718549|3164327|Superiority||Hazard Ratio (HR)|0.21||||0.417|2-Sided|95.0|0.005|9.1|||Cox’s proportional hazards model|||Multivariate Comparison: ZAP-70 Expression Negative versus Positive|
1718602|NCT00718549|3164327|Superiority||Hazard Ratio (HR)|26.275||||0.048|2-Sided|95.0|1.036|666.708|||Cox’s proportional hazards model|||Multivariate Comparison: Beta-2-Microglobulin >/= Median Value versus Beta-2-Microglobulin <Median Value|
1718603|NCT00718549|3164327|Superiority||Hazard Ratio (HR)|2.282||||0.728|2-Sided|95.0|0.022|240.864|||Cox’s proportional hazards model|||Multivariate Comparison: Rai Stage: I or II versus Rai Stage: III or IV|
1718604|NCT00718549|3164327|Superiority||Hazard Ratio (HR)|0.068||||0.128|2-Sided|95.0|0.002|2.158|||Cox’s proportional hazards model|||Multivariate Comparison: Sex: Female versus Male|
1718605|NCT00718549|3164327|Superiority||Hazard Ratio (HR)|0.769||||0.752|2-Sided|95.0|0.151|3.92|||Cox’s proportional hazards model|||Multivariate Comparison: Age <60 years versus Age >/=60 years|
1718606|NCT00718549|3164328|Superiority||Odds Ratio (OR)|0.625||||0.634|2-Sided|95.0|0.073|4.114|||Regression, Logistic|||Week 129: Univariate comparison|
1718607|NCT00718549|3164329|Superiority||Odds Ratio (OR)|3.654||||0.155|2-Sided|95.0|0.674|28.337|||Regression, Logistic|||Week 129: Univariate Comparison|
1718608|NCT00718549|3164330|Superiority||Hazard Ratio (HR)|0.052||||0.111|2-Sided|95.0|0.001|1.972|||Cox’s proportional hazards model|||Multivariate Comparison|
1718609|NCT00718549|3164330|Superiority||Hazard Ratio (HR)|0.418||||0.033||95.0|0.187|0.933|||Cox's proportional hazards regression|||Univariate comparison|
1718610|NCT00718549|3164330|Superiority|||||||0.028|||||||Log Rank||||
1718829|NCT00713609|3164944|Superiority or Other||||||<|0.618||||||For TC|ANCOVA||||
1718611|NCT00718510|3164335|Other|||||||0.55|||||||ANOVA|||Null hypothesis is that there was no difference in change of CDSS ratings between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time).|
1718612|NCT00718510|3164336|Other|||||||0.46|||||||ANOVA|||Null hypothesis is that there was no difference in change of CGI ratings between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time).|
1718613|NCT00718510|3164337|Other||||||<|0.05||||||General Psychopathology Subscale Score|ANOVA|F(1,11)=5.03||Null hypothesis is that there was no difference in change of PANSS between L-arginine and Placebo. A two-factor ANOVA was used across all subjects with the within-subject factor being the treatment phase (L-arginine first/Placebo second or Placebo first/L-arginine second) and the between-subject factor being the day of treatment (time). A sample size of 14 patients was needed to give 90% power to detect a 4 point difference on the PANSS. This included a drop-out rate of about 10%.|
1718614|NCT00718315|3164339|Superiority or Other|||||||0.308|||||||Kruskal-Wallis||||
1718615|NCT00718315|3164340|Superiority or Other|||||||0.087|||||||Kruskal-Wallis||||
1718616|NCT00718315|3164341|Superiority or Other|||||||0.066|||||||Kruskal-Wallis||||
1718617|NCT00718315|3164342|Superiority or Other|||||||0.179|||||||Chi-squared||||
1718618|NCT00718315|3164343|Superiority or Other|||||||0.108|||||||Chi-squared||||
1718619|NCT00718315|3164344|Superiority or Other|||||||0.199|||||||Chi-squared||||
1718620|NCT00718315|3164345|Superiority or Other|||||||0.095|||||||Log Rank||||
1718621|NCT00718315|3164347|Superiority or Other|||||||0.986||||||Test for Binomial Ratio, where H0: P >=61%; Ha: P < 61% (One-tailed Test)|t-test, 1 sided||||
1718622|NCT00718315|3164347|Superiority or Other|||||||0.933||||||Test for Binomial Ratio, where H0: P >=61%; Ha: P < 61% (One-tailed Test)|t-test, 1 sided||||
1718623|NCT00718315|3164347|Superiority or Other|||||||0.481||||||Test for Binomial Ratio, where H0: P >=61%; Ha: P < 61% (One-tailed Test)|t-test, 1 sided||||
1718624|NCT00718237|3164353|Superiority or Other||Vaccine Efficacy (1-Relative Risk [RR])|100.0|||<|0.001|2-Sided|95.0|55.4|100.0||Hypothesis: Efficacy >0%. Based on p< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.||
1718625|NCT00718237|3164354|Superiority or Other||Vaccine Efficacy (1-Relative Risk [RR])|74.5|||<|0.001|2-Sided|95.0|39.9|90.6||Hypothesis: Efficacy >0%. Based on p< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.||
1718626|NCT00718237|3164355|Superiority or Other||Vaccine Efficacy (1-Relative Risk [RR])|80.2|||<|0.001|2-Sided|95.0|47.4|94.1||Hypothesis: Efficacy >0%. Based on p< 1/(1+k); p = proportion of participants with outcome in vaccine group relative to total number of subjects with outcome; k = ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact Conditional Test|Exact Conditional Test based on Binomial Distribution|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group, adjusted for the ratio of the follow-up period in each group.||
1718627|NCT00718094|3164367|Superiority|||||||0.03|||||||Fisher Exact||||
1718628|NCT00718081|3164369|Superiority or Other||Mean Difference (Final Values)|24.62|Standard Error of the Mean|4.86|<|0.001|1-Sided|95.0|||||ANCOVA||||
1718629|NCT00718081|3164369|Superiority or Other||Mean Difference (Final Values)|19.48|Standard Error of the Mean|4.92|<|0.001|1-Sided|95.0|||||ANCOVA||||
1718630|NCT00718042|3164373|Superiority or Other||Percentage|99.1|||||2-Sided|95.0|97.4|99.8|||||||
1718631|NCT00718042|3164376|Superiority or Other||Point estimate|100.0|||||2-Sided|95.0|96.7|100.0|||||||
1718632|NCT00718042|3164378|Superiority or Other||Specificity|99.86|||||2-Sided|95.0|99.79|99.91|||||Numerator = All blood donors tested nonreactive from all True Negative blood donors (16,223) Denominator = All True Negative blood donors (16,246) True Negative excludes donor specimens positive by supplemental testing (3)||
1718633|NCT00717977|3164401|Superiority or Other||||||<|0.001||||||Adjusted for device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.|
1718634|NCT00717977|3164402|Superiority or Other|||||||0.04||||||Adjusted for CGM device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.|
1718635|NCT00717977|3164403|Superiority or Other|||||||0.009||||||Adjusted for CGM device type. Age was analyzed as continuous.|Regression, Linear|||The associations of mean sensor glucose and glucose variability measures with age were assessed using least-squares regression models adjusting for device type.|
1718636|NCT00717314|3164440|Superiority or Other|||||||1|||||||ANCOVA||||
1718637|NCT00717314|3164441|Superiority or Other|||||||0.764|||||||ANCOVA|ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment*study center as factors.||Change from Baseline at Week 52|
1718638|NCT00717314|3164441|Superiority or Other|||||||0.267||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment*study center as factors.|ANCOVA|||Change from Baseline at Week 40|
1718639|NCT00717314|3164441|Superiority or Other|||||||0.334||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment*study center as factors.|ANCOVA|||Change from Baseline at Week 28|
1718640|NCT00717314|3164441|Superiority or Other|||||||0.616||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment*study center as factors.|ANCOVA|||Change from Baseline at Week 16|
1718641|NCT00717314|3164442|Superiority or Other||Mean Difference (Final Values)|0.11|||||2-Sided|95.0|-5.342|5.561|||||||
1718642|NCT00717314|3164443|Superiority or Other|||||||0.432||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment*study center as factors.|ANCOVA|||Change from Baseline at Week 40|
1718643|NCT00717314|3164443|Superiority or Other|||||||0.722||||||ANCOVA model with calculated creatinine clearance at baseline as covariate, and study center and treatment*study center as factors.|ANCOVA|||Change from Baseline at Week 28|
1718644|NCT00717314|3164443|Superiority or Other|||||||0.685||||||Analysis of covariance (ANCOVA) model with calculated creatinine clearance at baseline as covariate, and study center and treatment*study center as factors.|ANCOVA|||Change from Baseline at Week 16|
1718645|NCT00717314|3164443|Superiority or Other|||||||0.374|||||||ANOVA|||Between group comparison at Baseline|
1718646|NCT00717314|3164446|Superiority or Other|||||||0.494|||||||ANOVA||||
1718647|NCT00717197|3164495|Superiority or Other||Percentage|21.7|Standard Error of the Mean|7.27|||2-Sided|95.0|7.46|43.7|||||||
1718648|NCT00717093|3164496|Superiority or Other||Odds Ratio (OR)|1.42||||0.0919|2-Sided|95.0|0.94|2.13||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine was imputed as negative|Odds ratio obtained from a logistic regression model including the main effects of treatment and center|Week 26|
1718649|NCT00717093|3164496|Superiority or Other||Odds Ratio (OR)|2.28|||<|0.0001|2-Sided|95.0|1.52|3.41||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine was imputed as negative|Odds ratio obtained from a logistic regression model including the main effects of treatment and center|Week 12|
1718650|NCT00717093|3164497|Superiority or Other||Odds Ratio (OR)|1.77||||0.0063|2-Sided|95.0|1.17|2.67|||Regression, Logistic|Missing salivary cotinine values were imputed as negative.|||
1718651|NCT00717093|3164498|Superiority or Other||Odds Ratio (OR)|1.7||||0.0118|2-Sided|95.0|1.12|2.58||p-value obtained from a logistic regression model including the main effects of treatment and center|Regression, Logistic|Missing salivary cotinine values were imputed as negative|Odds Ratio obtained from a logistic regression model including the main effects of treatment and center|Week 26|
1718652|NCT00717093|3164499|Superiority or Other||Odds Ratio (OR)|2.39|||<|0.0001|2-Sided|95.0|1.59|3.58||p-values obtained from logistic regression model including main effects of treatment and center|Regression, Logistic|Missing salivary cotinine values imputed as negative|Odds ratio obtained from logistic regression model including main effects of treatment and center||
1718653|NCT00717067|3164508|Superiority or Other||ratio of adjusted geometric means|323.91||||||90.0|174.32|601.88||||||Ratio (%) test (severe) / reference (normal).|
1718654|NCT00717067|3164510|Superiority or Other||ratio of adjusted geometric means|238.73||||||90.0|106.83|533.48||||||Ratio (%) test (severe) / reference (normal).|
1718655|NCT00717067|3164510|Superiority or Other||ratio of adjusted geometric means|70.9||||||90.0|47.83|105.1||||||Ratio (%) test (moderate) / reference (normal).|
1718656|NCT00717067|3164510|Superiority or Other||ratio of adjusted geometric means|121.01||||||90.0|83.15|176.13||||||Ratio (%) test (mild) / reference (normal).|
1718657|NCT00717067|3164511|Superiority or Other||ratio of adjusted geometric means|115.95||||||90.0|82.23|163.5||||||Ratio (%) test (moderate) / reference (normal).|
1718658|NCT00717067|3164511|Superiority or Other||ratio of adjusted geometric means|151.99||||||90.0|109.53|210.92||||||Ratio (%) test (mild) / reference (normal).|
1718659|NCT00717067|3164512|Superiority or Other||ratio of adjusted geometric means|322.23||||||90.0|171.97|603.78||||||Ratio (%) test (severe) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.|
1718660|NCT00717067|3164512|Superiority or Other||ratio of adjusted geometric means|88.31||||||90.0|61.97|125.83||||||Ratio (%) test (moderate) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.|
1718661|NCT00717067|3164512|Superiority or Other||ratio of adjusted geometric means|129.17||||||90.0|92.16|181.04||||||Ratio (%) test (mild) / reference (normal). AUClast was calculated using the log-linear trapezoidal method.|
1718662|NCT00716859|3164536|Superiority or Other|||||||0.3315|||||||Cochran-Mantel-Haenszel|P-value from a Cochran-Mantel-Haenszel chi-square test stratified by baseline diagnosis (PCG vs non-PCG).|||
1718663|NCT00716859|3164541|Superiority or Other||Mean Difference (Net)|0.4085|||||2-Sided|95.0|-1.1|2.67|||||||
1718664|NCT00716859|3164542|Superiority or Other||Mean Difference (Net)|1.62|||||2-Sided|95.0|-1.0|4.25|||||||
1718665|NCT00716859|3164543|Superiority or Other||Mean Difference (Net)|0.68|||||2-Sided|95.0|-1.66|3.02|||||||
1718666|NCT00716859|3164544|Non-Inferiority or Equivalence|If lower limit of 95% Confidence Interval (CI) for treatment difference is above non-inferiority margin, then non-inferiority concluded. If lower limit of 95% CI for treatment difference is above non-inferiority margin and above zero, then superiority concluded. The difference and 95% CI of the difference in IOP reduction (Week 12) was computed from an analysis of covariance (ANCOVA) model with treatment and baseline diagnosis as factors and baseline IOP as covariate.|Mean Difference (Net)|1.46|||||2-Sided|95.0|-0.81|3.74||||||Null hypothesis: latanoprost inferior to timolol (0.5 percent [%] optionally 0.25% for participants younger than 3 years). Power calculation: assuming common standard deviation (7 mmHg), 110 participants have 84% power to demonstrate latanoprost not inferior to timolol within 3 mmHg margin, assuming latanoprost has 1 mmHg reduction more than timolol in mean change from baseline IOP.|
1718667|NCT00716482|3164575|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|Kruskal-Wallis one-way ANOVA. Kruskal-Wallis was performed once to get p-values for all of the 9 categories at once.||Null hypothesis: no variance of similarity exists between the three groups|
1718680|NCT00716482|3164576|Superiority or Other||Median elasticity ratio specificity|0.649|||<|0.006|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median elasticity ratio.~Null hypothesis is that there is no difference between the two tests."|
1718668|NCT00716482|3164576|Superiority or Other||Max. color scale sensitivity, aggressive|0.986||||0.21|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).~Null hypothesis is that there is no difference between the two tests."|
1718669|NCT00716482|3164576|Superiority or Other||Max.color scale sensitivity,conservative|0.997||||0.008|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).~Null hypothesis is that there is no difference between the two tests."|
1718670|NCT00716482|3164576|Superiority or Other||median elasticity ratio sensitivity|0.983||||0.083|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median elasticity ratio.~Null hypothesis is that there is no difference between the two tests."|
1718671|NCT00716482|3164576|Superiority or Other||diameter ratio sensitivity|0.99||||0.025|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image diameter ratio.~Null hypothesis is that there is no difference between the two tests."|
1718672|NCT00716482|3164576|Superiority or Other||median mean elasticity value sensitivity|0.986||||0.046|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median mean elasticity value.~Null hypothesis is that there is no difference between the two tests."|
1718673|NCT00716482|3164576|Superiority or Other||max. elasticity sensitivity,aggressive|0.972|||>|0.99|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."|
1718674|NCT00716482|3164576|Superiority or Other||elasticity homegeneity,conservative,sens|0.99|||>|0.025|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05~Overall sensitivity = 99.0%"|McNemar|||"Elastography image sensitivity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."|
1718675|NCT00716482|3164576|Superiority or Other||elasticity homogeneity,aggressive,sensit|0.962|||>|0.37|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).~Null hypothesis is that there is no difference between the two tests."|
1718676|NCT00716482|3164576|Superiority or Other||Lesion homogeneity sens, conservative|0.969|||>|0.74|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image sensitivity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).~Null hypothesis is that there is no difference between the two tests."|
1718677|NCT00716482|3164576|Superiority or Other||Lesion shape sensitivity|0.979|||>|0.48|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in sensitivity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image lesion shape.~Null hypothesis is that there is no difference between the two tests."|
1718678|NCT00716482|3164576|Superiority or Other||Max. color scale specificity, aggressive|0.785|||<|0.001|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05~Overall specificity = 78.5%"|McNemar|||"Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue, or light blue).~Null hypothesis is that there is no difference between the two tests."|
1718679|NCT00716482|3164576|Superiority or Other||Max.color scale specificity,conservative|0.703|||<|0.001|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of color using a six-point color scale of maximum elasticity in the mass and surrounding parenchyma using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if the max stiffness on the color overlay SW elastographic image was red; BIRADS 4a mass downgraded to BIRADS 3' if the max stiffness on the color overlay SW elastographic image was black to dark blue).~Null hypothesis is that there is no difference between the two tests."|
1718681|NCT00716482|3164576|Superiority or Other||Diameter ratio specificity|0.512|||<|0.006|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image diameter ratio.~Null hypothesis is that there is no difference between the two tests."|
1718682|NCT00716482|3164576|Superiority or Other||median mean elasticity value specificity|0.626|||<|0.18|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image median mean elasticity value.~Null hypothesis is that there is no difference between the two tests."|
1718683|NCT00716482|3164576|Superiority or Other||Max. elasticity specificity, aggressive|0.774|||<|0.001|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the maximum elasticity using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kPa(7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 80 kPa (5.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."|
1718684|NCT00716482|3164576|Superiority or Other||Max. elasticity specificity,conservative|0.657|||<|0.001|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the maximum elasticity using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if maximum elasticity was 160 kiloPascals (kPa) (7.3 m/sec) or more; BIRADS 4a mass downgraded to BIRADS 3' if the maximum elasticity was 30 kPa (3.2 m/sec) or less).~Null hypothesis is that there is no difference between the two tests."|
1718685|NCT00716482|3164576|Superiority or Other||Lesion homogeneity spec, agressive|0.785|||<|0.001|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using aggressive strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very or reasonably homogeneous).~Null hypothesis is that there is no difference between the two tests."|
1718686|NCT00716482|3164576|Superiority or Other||Lesion homogeneity spec, conservative|0.714|||<|0.001|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||"Elastography image specificity of the homogeneity of elasticity with the lesion and surrounding tissue using conservative strategy (BIRADS 3 mass upgraded to BIRADS 4a' if they were not homogeneous on the color overlay SW elastographic image; BIRADS 4a mass downgraded to BIRADS 3' if they were very homogeneous).~Null hypothesis is that there is no difference between the two tests."|
1718687|NCT00716482|3164576|Superiority or Other||Specificity of lesion shape|0.694|||<|0.001|2-Sided|95.0||||"P-value was that to test the null hypothesis that there is no change in specificity with addition of the ShearWave elastographic feature.~Significance threshold P-value = 0.05"|McNemar|||Null hypothesis is that there is no difference between the two tests.|
1718688|NCT00716144|3164680|Superiority or Other|||||||0.03|||||||Cochran-Armitage Trend Test|||At Visit 8|
1718689|NCT00716144|3164680|Superiority or Other|||||||0.721|||||||Cochran-Armitage Trend Test|||At Visit 7|
1718690|NCT00716144|3164680|Superiority or Other|||||||0.55|||||||Cochran-Armitage Trend Test|||At Visit 5|
1718691|NCT00716144|3164680|Superiority or Other|||||||0.673|||||||Cochran-Armitage Trend Test|||At Visit 4|
1718692|NCT00716144|3164680|Superiority or Other|||||||1|||||||Cochran-Armitage Trend Test|||At Visit 3|
1718693|NCT00716144|3164682|Superiority or Other|||||||0.019|||||||Cochran-Armitage Trend Test|||At Visit 8|
1718694|NCT00716144|3164682|Superiority or Other|||||||0.034|||||||Cochran-Armitage Trend Test|||At Visit 7|
1718695|NCT00716144|3164682|Superiority or Other|||||||0.042|||||||Cochran-Armitage Trend Test|||At Visit 6|
1718696|NCT00716144|3164682|Superiority or Other|||||||0.463|||||||Cochran-Armitage Trend Test|||At Visit 5|
1718697|NCT00716144|3164682|Superiority or Other|||||||0.604|||||||Cochran-Armitage Trend Test|||At Visit 4|
1718698|NCT00716144|3164682|Superiority or Other|||||||1|||||||Cochran-Armitage Trend Test|||At Visit 3|
1718699|NCT00716144|3164683|Superiority or Other|||||||0.884|||||||Cochran-Armitage Trend Test||||
1718700|NCT00716092|3164684|Superiority or Other||Mean Difference (Final Values)|22.7|Standard Error of the Mean|18.6||0.223||95.0|-14.0|59.5|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.|
1718701|NCT00716092|3164685|Superiority or Other||Mean Difference (Final Values)|5.2|Standard Error of the Mean|4.3||0.2281||95.0|-3.3|13.8|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.|
1718702|NCT00716092|3164686|Superiority or Other||Mean Difference (Final Values)|2.8|Standard Error of the Mean|2.7||0.313||95.0|-2.7|8.2|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.|
1718703|NCT00716092|3164687|Superiority or Other||Mean Difference (Final Values)|6.0|Standard Error of the Mean|3.9||0.1274||95.0|-1.7|13.8|||ANCOVA|These measured values and statistical analysis come from a mixed model containing all three treatment groups, and adjusted as already described.||BI 1356 minus Sitagliptin. This analysis comparing BI1356 to Sitagliptin was conducted as an exploratory analysis at the time of analysing the study data. The study was not powered for such a comparison.|
1718704|NCT00716092|3164688|Superiority or Other||Mean Difference (Final Values)|-106.5|Standard Error of the Mean|20.3|<|0.0001||95.0|-147.0|-66.0|||ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo|
1718705|NCT00716092|3164689|Superiority or Other||Mean Difference (Final Values)|-10.8|Standard Error of the Mean|4.8||0.0283||95.0|-20.4|-1.2|||ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo|
1718706|NCT00716092|3164690|Superiority or Other||Mean Difference (Final Values)|18.1|Standard Error of the Mean|2.9|<|0.0001||95.0|12.4|23.9||There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) will be considered descriptive.|ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo|
1718707|NCT00716092|3164691|Superiority or Other||Mean Difference (Final Values)|-19.9|Standard Error of the Mean|4.0|<|0.0001||95.0|-28.0|-11.9||There was no adjustment for multiple primary endpoints, however a hierarchy approach to control for the Type-I error was used. If the endpoint WMG was not successful, any analysis of the GLP-1 (AUEC 0-24h) was to be considered descriptive.|ANCOVA|The primary analyses are based upon a model containing only BI1356 and Placebo. Sitagliptin values come from a different model containing all 3 groups||BI1356 minus Placebo|
1718708|NCT00715962|3164695|Superiority or Other||||||<|0.05|||||||ANCOVA||||
1718709|NCT00715962|3164696|Superiority or Other||||||<|0.05|||||||Fisher Exact|Fisher's exact test used as the rate of falling was low.|||
1718710|NCT00715884|3164723|Superiority or Other||Difference between event rates|0.47||||0.668|2-Sided|95.0|-1.72|1.96|||Fisher Exact||||
1718711|NCT00715884|3164724|Superiority or Other||Difference between event rates|0.0||||1|2-Sided|95.0|-2.14|1.28|||Fisher Exact||||
1718712|NCT00715884|3164725|Superiority or Other||Difference between event rates|-0.92||||0.341|2-Sided|95.0|-3.56|0.6|||Fisher Exact||||
1718713|NCT00715884|3164726|Superiority or Other||Difference between event rates|0.49||||0.801|2-Sided|95.0|-2.73|2.91|||Fisher Exact||||
1718714|NCT00715884|3164727|Superiority or Other||Difference between event rates|0.24||||1|2-Sided|95.0|-1.92|1.63|||Fisher Exact||||
1718715|NCT00715884|3164728|Superiority or Other||Difference between event rates|0.24||||1|2-Sided|95.0|-5.61|5.43|||Fisher Exact||||
1718716|NCT00715884|3164729|Superiority or Other||Difference between event rates|5.17||||0.17|2-Sided|95.0|-2.03|10.83|||Fisher Exact||||
1718717|NCT00715884|3164730|Superiority or Other||Difference between event rates|11.56||||0.14|2-Sided|95.0|-3.73|24.64|||Fisher Exact||||
1718718|NCT00715884|3164731|Superiority or Other||Difference between event rates|2.59||||0.2|2-Sided|95.0|-1.35|5.85|||Fisher Exact||||
1718719|NCT00715884|3164732|Superiority or Other||Difference between event rates|2.83||||0.166|2-Sided|95.0|-1.28|6.26|||Fisher Exact||||
1718720|NCT00715884|3164733|Superiority or Other||Difference between event rates|2.35||||0.22|2-Sided|95.0|-1.24|5.28|||Fisher Exact||||
1718721|NCT00715884|3164734|Superiority or Other||Difference between event rates|2.11||||0.203|2-Sided|95.0|-0.84|4.48|||Fisher Exact||||
1718722|NCT00715884|3164735|Superiority or Other||Difference between event rates|-1.3||||0.407|2-Sided|95.0|-3.5|1.4|||Fisher Exact||||
1718723|NCT00715884|3164736|Superiority or Other||Difference between event rates|0.7||||0.724|2-Sided|95.0|-2.2|4.2|||Fisher Exact||||
1718724|NCT00715884|3164737|Superiority or Other||Difference between event rates|13.8|||<|0.001|2-Sided|95.0|9.2|18.9|||Fisher Exact||||
1718725|NCT00715884|3164738|Superiority or Other||Difference between event rates|-0.4||||0.549|2-Sided|95.0|-1.3|1.0|||Fisher Exact||||
1718726|NCT00715884|3164739|Non-Inferiority or Equivalence|The null inferiority hypothesis was that the upper limit of the 95% confidence interval is equal or greater than the non-inferiority margin 5%. The alternative non-inferiority hypothesis for this study assumed that the upper limit of the 95% confidence interval would be less than the non-inferiority margin 5%.|Difference between TLF rates|2.58|||||1-Sided|95.0||5.55||||||Sample sizes of 1,061 from the ELITE™ group and 531 from the CYPHER® group were planned to achieve 90 percent power at a 2.5 percent significance level using an one-sided equivalence test, assuming a 10 percent TLF rate in each group and the maximum allowable rate difference between the groups being 5 percent. The total sample size was increased to 1,770 patients to account for an approximately 90 percent compliance to clinical follow-up.|
1718727|NCT00715728|3164755|Non-Inferiority|The non-inferiority margin is defined as 0.5 °C. Non-inferiority at the 0.025 significance level will be claimed if the lower limit of the 95% confidence interval is higher than the -0.5 °C.|Mean Difference (Final Values)|-0.12||||0.018|2-Sided|95.0|-0.37|0.14||P-value was adjusted for preoperative oral temperature and ASA physical status.|t-test, 1 sided||Non-inferiority will be established, at the 0.025 significance level, if the lower limit of a 95% confidence interval for the difference is above -0.5 °C.|Null hypothesis is the Hot dog resistive heating system is inferior to the Bair Hugger forced air system. Mean difference (95% CI) of the intraoperative TWA temperature between the groups (resistive heating versus forced-air) will be adjusting for preoperative oral temperature and ASA physical status.|
1718728|NCT00715728|3164756|Equivalence|Our primary outcome was the rate of core rewarming during the surgery. Groups were compared on mean rewarming rate in a linear mixed effects regression model with within-subject change of core temperature over time as random effect. Using those model results, equivalence on the mean rate of rewarming for the resistive and warm air systems was assessed with the 2 one-tailed tests equivalence testing approach and equivalence delta of 0.2 degrees C/hours.|||||<|0.001||||||Two 1-tailed tests were conducted. P-value for lower delta was 0.91. Equivalence will be claimed if p-values for upper and lower delta are both lower than 0.05 ⁄ 2 = 0.025.|t-test, 1 sided|||A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.|
1718823|NCT00713609|3164943|Superiority or Other|||||||0.02|||||||Cochran-Mantel-Haenszel||||
1718729|NCT00715728|3164756|Equivalence|Our primary outcome was the rate of core rewarming during the surgery. Groups were compared on mean rewarming rate in a linear mixed effects regression model with within-subject change of core temperature over time as random effect. Using those model results, equivalence on the mean rate of rewarming for the resistive and warm air systems was assessed with the 2 one-tailed tests equivalence testing approach and equivalence delta of 0.2 degrees C/hours.|||||<|0.91||||||Two 1-tailed tests were conducted. P-value for lower delta was 0.91. Equivalence will be claimed if p-values for upper and lower delta are both lower than 0.05 ⁄ 2 = 0.025.|t-test, 1 sided|"Two 1-tailed tests were conducted to assess equivalence. See  Type of Statistical Test."||A total of 46 patients (23 per group) were needed to have 90% power to demonstrate equivalence of the two warming methods on final intra-operative temperature at the 0.05 significance level using the 2 one-tailed tests equivalence testing technique and an equivalence region of 0.5 degrees C per hour, assuming a SD of 0.5 degrees C/hour for each group and zero true difference.|
1718730|NCT00715676|3164759|Superiority or Other||Mean Difference (Net)|0.582||||||90.0|0.573|0.591|||||||
1718731|NCT00715676|3164759|Superiority or Other||Mean Difference (Net)|0.173||||||90.0|0.164|0.181|||||||
1718732|NCT00715676|3164760|Superiority or Other|||||||0.124|||||||ANOVA||||
1718733|NCT00715676|3164760|Superiority or Other|||||||0.928|||||||ANOVA||||
1718734|NCT00715676|3164761|Superiority or Other|||||||0.523|||||||ANOVA||||
1718735|NCT00715676|3164761|Superiority or Other|||||||0.395|||||||ANOVA||||
1718736|NCT00715676|3164762|Superiority or Other|||||||0.173|||||||ANOVA||||
1718737|NCT00715676|3164762|Superiority or Other|||||||0.778|||||||ANOVA||||
1718738|NCT00715676|3164763|Superiority or Other|||||||0.243||||||The Hochberg method was used to compare dose groups to placebo and control the Type 1 error rate.|ANOVA|||A sample size of 49 per treatment group was calculated to have at least 90% power to detect a 2% or greater increase over placebo assuming the following: (1) a standard deviation of the percent change of 2.75% (2) a dropout rate of 30%, and (3) one-sided 0.05 level of significance|
1718739|NCT00715676|3164763|Superiority or Other|||||||0.641||||||The Hochberg method was used to compare dose groups to placebo and control the Type 1 error rate.|ANOVA|||A sample size of 49 per treatment group was calculated to have at least 90% power to detect a 2% or greater increase over placebo assuming the following: (1) a standard deviation of the percent change of 2.75% (2) a dropout rate of 30%, and (3) one-sided 0.05 level of significance|
1718740|NCT00715624|3164779|Superiority or Other||Least squares (LS) mean difference|-0.36|Standard Error of the Mean|0.096||0.0002|2-Sided|95.0|-0.55|-0.174||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (<8.0, >=8.0%), metformin use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|To control type I error, a step-down procedure described by Hochberg and Tomhane was applied.||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 300 patients in lixisenatide arm and 150 in placebo arm would provide a power of 96% (or 86%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.|
1718741|NCT00715429|3164793|Superiority or Other (legacy)|||||||0.27||||||Daily cramp rate at baseline& on treatment, were calculated as % of each subjects total # of cramps, for comparison among subjects. Change in % cramp rates from baseline to treatment was computed for each subject in vit D and placebo groups.|t-test, 2 sided|T test was used to compare the change in % cramp rate from baseline to treatment for each subject in each treatment group.|||
1718742|NCT00715117|3164819|Superiority or Other|||||||1|||||||Fisher Exact|||Double vision|
1718743|NCT00715117|3164819|Superiority or Other|||||||1|||||||Fisher Exact|||Papules, rash|
1718744|NCT00715117|3164819|Superiority or Other|||||||1|||||||Fisher Exact|||Flushed ears|
1718745|NCT00715117|3164819|Superiority or Other|||||||1|||||||Fisher Exact|||Fatigue|
1718746|NCT00715117|3164819|Superiority or Other|||||||1|||||||Fisher Exact|||Hair loss|
1718747|NCT00715117|3164819|Superiority or Other|||||||1|||||||Fisher Exact|||Nausea|
1718748|NCT00715117|3164819|Superiority or Other|||||||1|||||||Fisher Exact|||Decreased appetite|
1718749|NCT00715117|3164819|Superiority or Other|||||||1|||||||Fisher Exact|||Headaches|
1718750|NCT00715117|3164819|Superiority or Other|||||||1|||||||Fisher Exact|||Twitching|
1718751|NCT00715117|3164819|Superiority or Other|||||||0.45|||||||Fisher Exact|||Unusual dreams|
1718752|NCT00715117|3164819|Superiority or Other|||||||1|||||||Fisher Exact|||Sleep disturbance|
1718753|NCT00715117|3164820|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Body Image|
1718754|NCT00715117|3164820|Superiority or Other||||||>|0.035||||||Systemic symptoms|t-test, 2 sided||||
1718755|NCT00715117|3164820|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Emotional well-being|
1718756|NCT00715117|3164820|Superiority or Other||||||>|0.035|||||||t-test, 2 sided|||Social well-being|
1718757|NCT00715117|3164820|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Bowel symptoms|
1718758|NCT00715117|3164821|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1718759|NCT00715117|3164821|Superiority or Other||||||>|0.005|||||||t-test, 2 sided||||
1718760|NCT00715104|3164822|Superiority or Other|||||||0.048||||||P value is based on the treatment effect in the mixed model|Mixed Models Analysis|Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.|
1718761|NCT00715104|3164823|Superiority or Other|||||||0.95||||||P value is based on the treatment effect in the mixed model|Mixed Models Analysis|Mixed model includes randomization group, visit, and randomization group × visit interaction, with subject as a random effect.||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.|
1718824|NCT00713609|3164943|Superiority or Other|||||||0.132|||||||Cochran-Mantel-Haenszel||||
1718825|NCT00713609|3164943|Superiority or Other|||||||0.922|||||||Cochran-Mantel-Haenszel||||
1718826|NCT00713609|3164944|Superiority or Other||||||<|0.001||||||For TC|ANCOVA||||
1718762|NCT00715104|3164824|Superiority or Other|||||||0.249||||||P value compares 72 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.|
1718763|NCT00715104|3164824|Superiority or Other|||||||0.432||||||P value compares 48 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.|
1718764|NCT00715104|3164824|Superiority or Other|||||||0.086||||||P value compares 24 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.|
1718765|NCT00715104|3164825|Superiority or Other|||||||0.699||||||P value compares 72 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.|
1718766|NCT00715104|3164825|Superiority or Other|||||||0.191||||||P value compares 48 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.|
1718767|NCT00715104|3164825|Superiority or Other|||||||0.667||||||P value compares 24 week post-RP to pre-booster (12 weeks post RP)|Mixed Models Analysis|||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach to allow for a varying number of follow-up measurements. The ranked data were used in the statistical model.|
1718768|NCT00715104|3164826|Superiority or Other|||||||0.173||||||P value is for the visit effect in the mixed model|Mixed Models Analysis|Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.||Repeated measure analysis of variance (ANOVA) methods with a mixed model approach was used. The ranked data were used in the statistical model.|
1718769|NCT00715104|3164827|Superiority or Other||||||<|0.001||||||P value is for the visit effect in the mixed model|Mixed Models Analysis|Randomization groups, visits (up to 12-weeks Post-RP), and randomization groups × visits interaction were included in the mixed model.||The change over time was evaluated by using repeated measure analysis of variance (ANOVA) methods with a mixed model approach. The ranked data were used in the statistical model.|
1718770|NCT00715104|3164828|Superiority or Other||% subjects with 2-fold increase|83.8|||<|0.001|2-Sided|95.0|69.3|98.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.|
1718771|NCT00715104|3164828|Superiority or Other||% subjects with 2-fold increase|29.7|||<|0.036|2-Sided|95.0|11.7|47.7||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.|
1718772|NCT00715104|3164828|Superiority or Other||% subjects with 2-fold increase|35.1|||<|0.002|2-Sided|95.0|16.3|53.9||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD8+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD8+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.|
1718773|NCT00715104|3164829|Superiority or Other||% subjects with 2-fold increase|79.4|||<|0.001|2-Sided|95.0|62.8|96.0||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.|
1718774|NCT00715104|3164829|Superiority or Other||% subjects with 2-fold increase|32.4|||<|0.014|2-Sided|95.0|13.1|51.6||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.|
1718775|NCT00715104|3164829|Superiority or Other||% subjects with 2-fold increase|20.6|||<|1|2-Sided|95.0|4.0|37.2||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD4+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD4+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.|
1718776|NCT00715104|3164830|Superiority or Other||% Subjects with 2-fold increase|70.3|||<|0.001|2-Sided|95.0|52.3|88.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.|
1718777|NCT00715104|3164830|Superiority or Other||% Subjects with 2-fold increase|18.9|||<|1|2-Sided|95.0|3.5|34.3||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.|
1718778|NCT00715104|3164830|Superiority or Other||% Subjects with 2-fold increase|16.2|||<|1|2-Sided|95.0|1.7|30.7||Bonferroni-adjusted p-values will be reported to alleviate the multiple testing problem; pbon = minimum of p*3 and 1 (p = the nominal p-value from the test, pbon = the Bonferroni-adjusted p-value). Confidence intervals will be adjusted similarly.|Chi-squared|||A 2-fold increase in CD3+ T cell counts from biopsy to post-RP was considered a positive response. The number of infiltrating CD3+ T cells/μm2 was coded as binary with each subject categorized as having at least a 2-fold increase from baseline or not. One sample Chi-square test for a binary response, with a null hypothesis of 15% was implemented. The tests were done using post-treatment post-RP benign tissue, tumor tissue, and tumor interface compared to the biopsy benign tissue.|
1718779|NCT00715078|3164831|Non-Inferiority or Equivalence|Cohort C is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval for the ratio of Cohort C vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is >0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of <20% in upregulation ratios may not be clinically significant.|the ratio of geometric means|0.907||||0.1443|2-Sided|90.0|0.813|1.013|||ANOVA|||The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).|
1718780|NCT00715078|3164831|Non-Inferiority or Equivalence|Cohort B is considered non-inferior to Cohort A if the lower limit of the 90% confidence interval (CI) for the ratio of Cohort B vs. Cohort A in the geometric mean of cumulative CD54 upregulation ratio is >0.8. The use of one-sided CI is based on an assumption that a higher concentration will correspond to a higher CD54 upregulation ratio. The use of 0.8 as margin is based on the assumption that a relative difference of <20% in upregulation ratios may not be clinically significant.|ratio of geometric means (GeoMean)|1.046||||0.5019|2-Sided|90.0|0.936|1.168|||ANOVA|||The sample size determination is based on a standard deviation of 0.45 for the log transformed CD54 upregulation ratio estimated from previous studies assuming there is no difference in central values between the two compared cohorts. A sample size of 38 subjects per cohort will provide 70% power for the non-inferiority test for the two pairwise comparisons (Cohort B vs. Cohort A and Cohort C vs. Cohort A).|
1718781|NCT00714688|3164844|Superiority or Other||Difference in Least-Squares Means|-4.4|Standard Error of the Mean|1.83||0.016||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.|
1718782|NCT00714688|3164844|Superiority or Other||Difference in Least-Squares Means|-4.2|Standard Error of the Mean|1.86||0.023||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.|
1718783|NCT00714688|3164845|Superiority or Other|||||||0.002||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender and country were used as factors and age was used as a covariate.|||
1718784|NCT00714688|3164845|Superiority or Other|||||||0.052||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender and country were used as factors and age was used as a covariate.|||
1718785|NCT00714688|3164846|Superiority or Other||||||<|0.001||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model has been performed on ranked data. Treatment, gender & country were used as factors and baseline value & age were used as covariates.||Statistical analysis of change from baseline at endpoint.|
1718786|NCT00714688|3164846|Superiority or Other||||||<|0.216||||||Comparison with placebo was performed without multiplicity adjustment.|ANCOVA|The ANCOVA model was performed on ranked data. Treatment, gender & country were used as factors and baseline value & age were used as covariates.||Statistical analysis of change from baseline at endpoint.|
1718787|NCT00714688|3164847|Superiority or Other||Difference in Least-Squares Means|-4.9|Standard Error of the Mean|1.5||0.002||95.0|-8.22|-1.55||The p value was adjusted for multiplicity via Dunnett's test procedure.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.|
1718788|NCT00714688|3164847|Superiority or Other||Difference in Least-Squares Means|-2.7|Standard Error of the Mean|1.51||0.136||95.0|-6.04|0.67||The p value was adjusted for multiplicity via Dunnett's test procedure.|ANCOVA|Treatment, gender and country were used as factors and baseline value and age were used as covariates.||Statistical analysis of change from baseline at endpoint.|
1718789|NCT00714493|3164851|Superiority or Other||||||<|0.001|||||||Wilcoxon signed rank test||||
1718790|NCT00714493|3164852|Superiority or Other||||||<|0.001|||||||Wilcoxon signed rank test||||
1718791|NCT00714233|3164902|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Paired t-test to analyze BMI at baseline and 24 weeks|
1718792|NCT00714051|3164909|Superiority or Other|||||||0.45|||||||Chi-squared|||The number of participants who fell on the tripping trial in each group were compared using Chi-square analysis|
1718793|NCT00713830|3164925|Superiority or Other||Least squares (LS) mean difference|-0.74|Standard Error of the Mean|0.063|<|0.0001|2-Sided|95.0|-0.867|-0.621||Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (<8.0, >=8.0%), metformin use (yes, no), country as fixed effects, baseline HbA1c as covariate.|ANCOVA|||To detect a difference of 0.5% (or 0.4%) in change from baseline to Week 24 in HbA1c between lixisenatide and placebo, 570 patients in lixisenatide arm and 285 in placebo arm would provide a power of 99% (or 98%) assuming common standard deviation of 1.3% with a 2-sided test at 5% significance level.|
1718794|NCT00713817|3164927|Superiority or Other||Odds Ratio (OR)|1.557||||0.603|2-Sided|95.0|0.293|8.261|||Regression, Logistic|||The two treatment groups were compared using ordinal logistic regression and the proportional odds model. The model incorporated the parent Randomised Controlled Trials (RCTs). The interaction between treatment group and parent RCTs was investigated, but was dropped from the model if found to have little influence. The test was performed at the 10% significance level. The final model was then treatment group and parent RCTs, i.e. the treatment effect was adjusted for parent RCTs baseline.|
1718795|NCT00713817|3164928|Superiority or Other||Estimate mean treatment difference|-0.08||||0.902|2-Sided|95.0|-1.45|1.29|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.|
1718796|NCT00713817|3164929|Superiority or Other||Estimated mean treatment difference|-7.14||||0.54|2-Sided|95.0|-39.7|9.62|||Hodges-Lehmann|||The difference in loss of response cumulative distribution functions between treatments was assessed using the Wilcoxon test with an estimate of the median difference between groups in response level (percent change from baseline) provided by the Hodges-Lehmann estimator.|
1718797|NCT00713817|3164930|Superiority or Other||Chi-square|0.048||||0.826||95.0|||||Log Rank|||Time to treatment failure was analysed using Kaplan-Meier Survival analysis methodology. The difference in loss of response cumulative distribution function between treatments was assessed using the Hodges-Lehmann estimate.|
1718798|NCT00713817|3164931|Superiority or Other||Estimated mean treatment difference|4.62||||0.296|2-Sided|95.0|-4.51|13.75|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.|
1718799|NCT00713817|3164932|Superiority or Other||Estimated mean treatment difference|0.89||||0.273|2-Sided|95.0|-0.78|2.56|||ANCOVA|||The two groups were compared using Analysis of Covariance (ANCOVA) with baseline severity as a covariate and study centre group and treatment group as factors. Due to the low power of the test for interaction the test was performed at the 10% level of significance and a 95% confidence interval (CI) was presented for the difference between treatments.|
1718800|NCT00713648|3164940|Superiority or Other||Mean (Lambda)|0.048||||||95.0|0.0094|0.2501|||||Mean (Lambda) refer to the estimate of the annualised bleeding rate||
1718801|NCT00713609|3164941|Superiority or Other|||||||0.005|||||||Cochran-Mantel-Haenszel||||
1718802|NCT00713609|3164941|Superiority or Other|||||||0.063|||||||Cochran-Mantel-Haenszel||||
1718803|NCT00713609|3164941|Superiority or Other|||||||0.312|||||||Cochran-Mantel-Haenszel||||
1718804|NCT00713609|3164941|Superiority or Other|||||||0.279|||||||Cochran-Mantel-Haenszel||||
1718805|NCT00713609|3164941|Superiority or Other|||||||0.652|||||||Cochran-Mantel-Haenszel||||
1718806|NCT00713609|3164942|Superiority or Other||||||<|0.001||||||For TC|ANCOVA||||
1718807|NCT00713609|3164942|Superiority or Other||||||<|0.085||||||For TC|ANCOVA||||
1718808|NCT00713609|3164942|Superiority or Other||||||<|0.291||||||For TC|ANCOVA||||
1718809|NCT00713609|3164942|Superiority or Other||||||<|0.62||||||For TC|ANCOVA||||
1718810|NCT00713609|3164942|Superiority or Other||||||<|0.006||||||For TC|ANCOVA||||
1718811|NCT00713609|3164942|Superiority or Other||||||<|0.001||||||For NILC|ANCOVA||||
1718812|NCT00713609|3164942|Superiority or Other||||||<|0.288||||||For NILC|ANCOVA||||
1718813|NCT00713609|3164942|Superiority or Other||||||<|0.465||||||For NILC|ANCOVA||||
1718814|NCT00713609|3164942|Superiority or Other||||||<|0.776||||||For NILC|ANCOVA||||
1718815|NCT00713609|3164942|Superiority or Other||||||<|0.001||||||For NILC|ANCOVA||||
1718816|NCT00713609|3164942|Superiority or Other||||||<|0.001||||||For ILC|ANCOVA||||
1718817|NCT00713609|3164942|Superiority or Other||||||<|0.084||||||For ILC|ANCOVA||||
1718818|NCT00713609|3164942|Superiority or Other||||||<|0.177||||||For ILC|ANCOVA||||
1718819|NCT00713609|3164942|Superiority or Other||||||<|0.504||||||For ILC|ANCOVA||||
1718820|NCT00713609|3164942|Superiority or Other||||||<|0.504||||||For ILC|ANCOVA||||
1718821|NCT00713609|3164943|Superiority or Other|||||||0.009|||||||Cochran-Mantel-Haenszel||||
1718822|NCT00713609|3164943|Superiority or Other|||||||0.706|||||||Cochran-Mantel-Haenszel||||
1718830|NCT00713609|3164944|Superiority or Other||||||<|0.006||||||For TC|ANCOVA||||
1718831|NCT00713609|3164944|Superiority or Other||||||<|0.001||||||For NILC|ANCOVA||||
1718832|NCT00713609|3164944|Superiority or Other||||||<|0.552||||||For NILC|ANCOVA||||
1718833|NCT00713609|3164944|Superiority or Other||||||<|0.175||||||For NILC|ANCOVA||||
1718834|NCT00713609|3164944|Superiority or Other||||||<|0.803||||||For NILC|ANCOVA||||
1718835|NCT00713609|3164944|Superiority or Other||||||<|0.001||||||For NILC|ANCOVA||||
1718836|NCT00713609|3164944|Superiority or Other||||||<|0.001||||||For ILC|ANCOVA||||
1718837|NCT00713609|3164944|Superiority or Other||||||<|0.075||||||For ILC|ANCOVA||||
1718838|NCT00713609|3164944|Superiority or Other||||||<|0.281||||||For ILC|ANCOVA||||
1718839|NCT00713609|3164944|Superiority or Other||||||<|0.467||||||For ILC|ANCOVA||||
1718840|NCT00713609|3164944|Superiority or Other||||||<|0.692||||||For ILC|ANCOVA||||
1718841|NCT00713310|3164966|Superiority or Other||High-Low Dose Difference Success Rates|1.4||||0.8193|2-Sided|95.0|-20.2|23.0|||Cochran-Mantel-Haenszel|||A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.|
1718842|NCT00713310|3164967|Superiority or Other||High-Low Dose Difference Success Rates|-1.1||||0.924|2-Sided|95.0|-22.7|20.5|||Cochran-Mantel-Haenszel|||A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.|
1718843|NCT00712920|3165002|Superiority or Other|||||||0.04|||||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate|||
1718844|NCT00712920|3165002|Superiority or Other|||||||0.292|||||||ANCOVA|ANCOVA was used as a model containing treatment group and site as fixed effects with the baseline value used as covariate|||
1718845|NCT00712920|3165003|Superiority or Other||Mean Difference (Final Values)|-1.1252|Standard Deviation|0.3649||0.002||95.0|-1.84|-0.41|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 28|
1718846|NCT00712920|3165003|Superiority or Other||Mean Difference (Final Values)|-0.4394|Standard Deviation|0.3631||0.226||95.0|-1.15|0.27|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline to Day 28|
1718847|NCT00712920|3165004|Superiority or Other||Mean Difference (Final Values)|-0.7925|Standard Deviation|0.3935||0.044||95.0|-1.56|-0.02|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.|||
1718848|NCT00712920|3165004|Superiority or Other||Mean Difference (Final Values)|-0.6419|Standard Deviation|0.3924||0.102||95.0|-1.41|0.13|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.|||
1718849|NCT00712920|3165005|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.08||95.0|-1.5|0.1|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.|||
1718850|NCT00712920|3165005|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.03||95.0|-1.7|-0.1|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.|||
1718851|NCT00712725|3165006|Superiority or Other||||||<|0.001||||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response SPF 2-24 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.|||
1718852|NCT00712725|3165007|Superiority or Other|||||||0.007||||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Nausea at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.|||
1718853|NCT00712725|3165008|Superiority or Other||||||<|0.001||||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Phonophobia at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.|||
1718854|NCT00712725|3165009|Superiority or Other||||||<|0.001||||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with Absence of Photophobia at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.|||
1718855|NCT00712725|3165010|Superiority or Other||||||<|0.001||||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with binary response PR at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.|||
1718856|NCT00712725|3165011|Superiority or Other||||||<|0.001||||||p-value constructed from trend test of dose response, by testing the slope of the MK3207 dose covariate (all dose groups included) in a generalized linear regression model with PF at 2 hours postdose as the dependent variable.|Generalized linear regression model|Model adjusted for geographic region (US, ex-US), baseline severity (moderate, severe), treatment and age (continuous), using identity link function.|||
1718875|NCT00711971|3165084|Superiority or Other|||||||0.19|||||||ANOVA||||
1718876|NCT00711971|3165085|Superiority or Other|||||||0.39|||||||ANOVA||||
1718968|NCT00711477|3165220|Superiority or Other||Mean Difference (Final Values)|0.7|||||2-Sided|90.0|0.5|0.9|||||||
1718857|NCT00712673|3165031|Superiority or Other||LS mean difference|-0.37|Standard Error of the Mean|0.088|<|0.0001|2-Sided|95.0|-0.54|-0.193||Stepwise testing procedure applied to control type 1 error: lixisenatide (morning) compared with placebo (combined), if found statistically significant, then lixisenatide (evening) compared with placebo (combined).|ANCOVA|||To detect 0.5%(or 0.4%) difference between 1 lixisenatide arm and placebo(combined), 225 patients in lixisenatide arm, 170 in placebo(combined) would provide a power of 97% (or 87%) assuming common standard deviation=1.3% with 2-sided test at 5% significance. Statistical testing:2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c(<8.0,>=8.0%),BMI(<30,>=30 kg/m^2),country as fixed effects, baseline HbA1c as covariate.|
1718858|NCT00712673|3165031|Superiority or Other||Least squares (LS) mean difference|-0.48|Standard Error of the Mean|0.088|<|0.0001|2-Sided|95.0|-0.657|-0.312||Stepwise testing procedure applied to control type 1 error: lixisenatide (morning) compared with placebo (combined), if found statistically significant, then lixisenatide (evening) compared with placebo (combined).|ANCOVA|||To detect 0.5%(or 0.4%) difference between 1 lixisenatide arm and placebo(combined), 225 patients in lixisenatide arm, 170 in placebo(combined) would provide a power of 97% (or 87%) assuming common standard deviation=1.3% with 2-sided test at 5% significance. Statistical testing:2-sided at significance level=0.05. Analysis of co-variance(ANCOVA)included treatment arms, randomization strata of screening HbA1c(<8.0,>=8.0%),BMI(<30,>=30 kg/m^2),country as fixed effects, baseline HbA1c as covariate.|
1718859|NCT00712179|3165062|Superiority or Other|||||||0.94|||||||Mixed Models Analysis|||Null Hypothesis: Modification of paretic leg loading and movement by the therapist will have significant effect on EMG pattern of non-paretic leg.|
1718860|NCT00712179|3165062|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Null Hypothesis: Modification of non-paretic leg loading and movement by the therapist will have no effect on EMG pattern of paretic leg.|
1718861|NCT00712179|3165062|Superiority or Other||||||<|0.073|||||||Mixed Models Analysis|||Null Hypothesis: Walking at fastest comfortable speeds with different amount of body weight supports will not affect the EMG pattern.|
1718862|NCT00712179|3165062|Superiority or Other||||||<|0.16|||||||Mixed Models Analysis|||Null Hypothesis: Walking at different speeds with 30% body weight support will have no effect on EMG pattern.|
1718863|NCT00712179|3165062|Superiority or Other||||||<|0.84|||||||Mixed Models Analysis|||Null Hypothesis: Walking at self selected speed at 0%, 15% and 30% of body weight support will have no effect on EMG pattern|
1718864|NCT00712179|3165062|Superiority or Other||||||<|0.981|||||||Mixed Models Analysis|||Null Hypothesis: Walking at different speeds with 15% body weight support will have no effect on EMG pattern.|
1718865|NCT00712166|3165063|Superiority or Other||Mean Difference (Final Values)|2.73||||0.021|2-Sided|95.0|0.42|5.04||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model includes treatment, baseline FEV1 % predicted, and age group (<18, >=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in % change from baseline in FEV1 % predicted at Day 28.|
1718866|NCT00712166|3165064|Superiority or Other||Mean Difference (Final Values)|-1.21||||0.016|2-Sided|95.0|-2.2|-0.23||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline log10 CFU, and age group (<18, >=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the log10 CFU at Day 28.|
1718867|NCT00712166|3165067|Superiority or Other|||||||0.122||||||No adjustments were made for multiple comparisons.|Fisher Exact|A participant with multiple hospitalizations was counted only once.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in proportion of participants hospitalized.|
1718868|NCT00712166|3165068|Superiority or Other||||||>|0.999||||||No adjustments were made for multiple comparisons.|Fisher Exact|A participant with multiple usage was counted only once.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants using additional (nonprotocol-specified) antipseudomonal antibiotics during study.|
1718869|NCT00712166|3165069|Superiority or Other||Mean Difference (Final Values)|2.47||||0.256||95.0|-1.81|6.76||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA included: treatment, baseline CFQ-R Physical Function Domain score and age (<18, >=18 years). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R physical functioning domain score at Day 28.|
1718870|NCT00712166|3165070|Superiority or Other||Mean Difference (Final Values)|0.1||||0.965|2-Sided|95.0|-4.56|4.76||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment, baseline CFQ-R RSS and age group (<18 years, >=18 years). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R RSS score at Day 42.|
1718871|NCT00712166|3165071|Superiority or Other||Mean Difference (Final Values)|3.37||||0.133|2-Sided|95.0|-1.04|7.78||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA included terms: treatment, baseline CFQ-R RSS, age group (<18, >=18 years). Treatment differences were calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in the CFQ-R RSS score at Day 14.|
1718872|NCT00712166|3165072|Superiority or Other||Mean Difference (Final Values)|1.8||||0.433|2-Sided|95.0|-2.83|6.44||"The primary endpoint analysis was based on a two-sided test with an 0.05 a priori threshold for statistical significance.~A gate-keeper approach was established a priori to control the type 1 error rate, however, the primary endpoint was not met."|ANCOVA|ANCOVA included: treatment, baseline CFQ-R RSS, age group (<18, >=18 years). Denominator degrees of freedom computed with Satterthwaite approximation.||"Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 28.~At the 5% significance level (i.e., α = 0.05) using a two-sided significance test, a sample size of 70 participants per treatment group provided at least 90% power to detect a 10 point difference between groups in the mean change from baseline at Day 28 in the CFQ-R RSS score, assuming a common standard deviation (SD) of 17.5."|
1718873|NCT00711971|3165082|Superiority or Other|||||||0.54|||||||ANOVA||||
1718874|NCT00711971|3165083|Superiority or Other||||||<|0.01|||||||ANOVA||||
1718877|NCT00711971|3165086|Superiority or Other||||||<|0.001|||||||ANOVA|Kruskal-Wallis test was used for outliers; Tukey multiple comparisons test was also used.|||
1718878|NCT00711971|3165087|Superiority or Other|||||||0.81|||||||ANOVA||||
1718879|NCT00711971|3165088|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1718880|NCT00711971|3165089|Superiority or Other|||||||0.32|||||||Fisher Exact|||Operative vaginal delivery|
1718881|NCT00711971|3165089|Superiority or Other|||||||0.88|||||||Fisher Exact|||Spontaneous vaginal delivery|
1718882|NCT00711971|3165089|Superiority or Other|||||||0.08|||||||Fisher Exact|||Cesarean section|
1718883|NCT00711971|3165089|Superiority or Other|||||||0.2|||||||Fisher Exact|||Induced labor|
1718884|NCT00711971|3165089|Superiority or Other|||||||0.12|||||||Fisher Exact|||Hypertension or preeclampsia|
1718885|NCT00711971|3165089|Superiority or Other|||||||0.06|||||||Fisher Exact|||Gestational diabetes mellitus|
1718886|NCT00711971|3165090|Superiority or Other|||||||0.56|||||||ANOVA|||BDI score at 6-8 weeks postpartum|
1718887|NCT00711971|3165090|Superiority or Other|||||||0.51|||||||ANOVA|||Significance for BDI at 34-36 weeks gestation|
1718888|NCT00711971|3165090|Superiority or Other|||||||0.29|||||||ANOVA|||Significance for the BDI test at 26-28 weeks|
1718889|NCT00711880|3165093|Superiority or Other||Estimated mean treatment difference|29.03||||0.001||95.0|13.39|44.67|||Fisher Exact|||The proportion of subjects who considered their condition ‘Very Much Improved’, ‘Much Improved’ or ‘Minimally Improved’ was compared between treatment groups for each question, using Fisher’s Exact Test.|
1718890|NCT00711880|3165095|Superiority or Other||Estimated mean treatment difference|32.26|||<|0.001|2-Sided|95.0|16.4|48.12|||Fisher Exact|||The proportion of subjects who considered their condition ‘Very Much Improved’, ‘Much Improved’ or ‘Minimally Improved’ was compared between treatment groups for each question, using Fisher’s Exact Test.|
1718891|NCT00711880|3165096|Superiority or Other||Estimated mean treatment difference|-0.08||||0.962|2-Sided|95.0|-3.56|3.39|||ANCOVA|||The change in word list generation test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline word list generation test score as a covariate.|
1718892|NCT00711880|3165097|Superiority or Other||Estimated mean treatment difference|1.28||||0.656|2-Sided|95.0|-4.47|7.04|||ANCOVA|||The change in paced auditory serial addition task score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline paced auditory serial addition task test score as a covariate.|
1718893|NCT00711880|3165098|Superiority or Other||Estimated mean treatment difference|-2.15||||0.158|2-Sided|95.0|-5.15|0.85|||ANCOVA|||The change in symbol digit modalities test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline symbol digit modalities test score as a covariate.|
1718894|NCT00711880|3165099|Superiority or Other||Estimated mean treatment difference|0.53||||0.214|2-Sided|95.0|-0.31|1.38|||ANCOVA|||The change in 10/36 spatial recall test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline 10/36 spatial recall test score as a covariate.|
1718895|NCT00711880|3165100|Superiority or Other||Estimated mean treatment difference|0.02||||0.924|2-Sided|95.0|-0.46|0.5|||ANCOVA|||The change in selective reminding test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline selective reminding test score as a covariate.|
1718896|NCT00711880|3165101|Superiority or Other||Estimated mean treatment difference|-0.75||||0.483|2-Sided|95.0|-2.84|1.35|||ANCOVA|||The change in total General Health Questionnaire score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total General Health Questionnaire score as a covariate.|
1718897|NCT00711880|3165102|Superiority or Other||Estimated mean treatment difference|12.73||||0.144|2-Sided|95.0|-4.4|29.85|||ANCOVA|||The change in Static Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Static Allodynia Test score as a covariate.|
1718898|NCT00711880|3165103|Superiority or Other||Estimated mean treatment difference|-0.82||||0.042|2-Sided|95.0|-1.6|-0.03|||ANCOVA|||The change in Dynamic Allodynia Test score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline Dynamic Allodynia Test score as a covariate.|
1718899|NCT00711880|3165104|Superiority or Other||Estimated mean treatment difference|-5.85||||0.003|2-Sided|95.0|-9.62|-2.09|||ANCOVA|||The change in total Pain Disability Index scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline total Pain Disability Index score as a covariate.|
1718900|NCT00711880|3165105|Superiority or Other||Estimated mean treatment difference|-0.43||||0.001|2-Sided|95.0|-0.67|-0.19|||ANCOVA|||The change in sleep disturbance scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and mean baseline sleep disturbance score as a covariate.|
1718901|NCT00711880|3165106|Superiority or Other||Estimated mean treatment difference|-8.03||||0.007|2-Sided|95.0|-13.83|-2.23|||ANCOVA|||The change in Neuropathic Pain Scale scores was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Neuropathic Pain Scale score as a covariate.|
1718902|NCT00711880|3165107|Superiority or Other||Estimated mean treatment difference|-0.96||||0.004|2-Sided|95.0|-1.59|-0.32|||ANCOVA|||The change in Numerical Rating Scale Peripheral Neuropathic Pain scores was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale Peripheral Neuropathic Pain score as a covariate.|
1718903|NCT00711867|3165108|Non-Inferiority or Equivalence|The non-inferiority margin was defined as -0.5 C.|Mean Difference (Final Values)|-0.34||||||95.0|-0.55|-0.14||||||H0: Mu_VH - Mu_BH <= -0.5 C.|
1718904|NCT00711711|3165118|Superiority or Other|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P<.05.|
1719113|NCT00709852|3165530|Superiority or Other||Difference|0.5||||0.6547|||||||McNemar||||
1718905|NCT00711711|3165119|Superiority or Other|||||||0.51|||||||Wilcoxon (Mann-Whitney)|||All outcomes and control variables were compared between the treatment and the control group at each time point using the Wilcoxon rank-sum test or the chi-square test, as appropriate. The change in swelling from second day to seventh day, that is, during the treatment period, was compared using the Wilcoxon signed-rank test. The significance level was set at P<.05.|
1718906|NCT00711646|3165120|Superiority or Other||Estimated mean treatment difference|3.86||||0.054|2-Sided|95.0|-0.06|7.78|||ANCOVA|||The change in mean Motricity Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Motricity Index score as a covariate.|
1718907|NCT00711646|3165122|Superiority or Other||Estimated mean treatment difference|8.46||||0.349|2-Sided|95.0|-6.74|23.66|||Fisher Exact|||The proportion of subjects who considered their condition ‘Very Much Improved’, ‘Much Improved’ or ‘Minimally Improved’ was compared between treatment groups using Fisher’s Exact Test.|
1718908|NCT00711646|3165123|Superiority or Other||Estimated mean treatment difference|1.3||||0.766|2-Sided|95.0|-7.47|10.07|||ANCOVA|||The change in mean Motricity Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Motricity Index score as a covariate.|
1718909|NCT00711646|3165124|Superiority or Other||Estimated mean treatment difference|-0.17||||0.141|2-Sided|95.0|-0.39|0.06|||ANCOVA|||The change in mean spasm frequency score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline spasm frequency score as a covariate.|
1718910|NCT00711646|3165125|Superiority or Other||Estimated mean treatment difference|-0.11||||0.218|2-Sided|95.0|-0.29|0.07|||ANCOVA|||The change in mean Ashworth Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Ashworth Scale score as a covariate.|
1718911|NCT00711646|3165126|Superiority or Other||Estimated mean treatment difference|-0.517||||0.048|2-Sided|95.0|-1.029|-0.004|||ANCOVA|||The change in mean 11-point Numerical Rating Scale spasticity score was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline 11-point Numerical Rating Scale spasticity score as a covariate.|
1718912|NCT00711516|3165158|Superiority or Other||Mean Difference (Net)|-25.1||||0.1305|2-Sided|95.0|-58.2|8.0|||ANCOVA||||
1718913|NCT00711516|3165159|Superiority or Other||Median Difference (Net)|-145.8||||0.8997|2-Sided|95.0|-3151.0|1006.5|||Wilcoxon (Mann-Whitney)||||
1718914|NCT00711516|3165160|Superiority or Other||Median Difference (Net)|-82.8||||0.5284|2-Sided|95.0|-788.0|165.5|||Wilcoxon (Mann-Whitney)||||
1718915|NCT00711516|3165161|Superiority or Other||Median Difference (Net)|1.0||||1|2-Sided|95.0|-1069.0|426.0|||Wilcoxon (Mann-Whitney)||||
1718916|NCT00711516|3165162|Superiority or Other||Median Difference (Net)|-323.5||||0.9282|2-Sided|95.0|-9311.0|2375.5|||Wilcoxon (Mann-Whitney)||||
1718917|NCT00711516|3165163|Superiority or Other||Median Difference (Net)|13.855||||0.1825||95.0|-15.357|25.714|||Wilcoxon (Mann-Whitney)||||
1718918|NCT00711516|3165164|Superiority or Other||Median Difference (Net)|0.108||||0.8711|2-Sided|95.0|-14.341|5.498|||Wilcoxon (Mann-Whitney)||||
1718919|NCT00711516|3165165|Superiority or Other||Median Difference (Net)|4.792||||0.5163|2-Sided|95.0|-30.631|16.19|||Wilcoxon (Mann-Whitney)||||
1718920|NCT00711516|3165166|Superiority or Other||Median Difference (Net)|4.841||||0.7053|2-Sided|95.0|-27.778|19.313|||Wilcoxon (Mann-Whitney)||||
1718921|NCT00711516|3165175|Superiority or Other|||||||0.0135|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.|||
1718922|NCT00711516|3165175|Superiority or Other|||||||0.901|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.|||
1718923|NCT00711516|3165176|Superiority or Other|||||||0.156|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.|||
1718924|NCT00711516|3165176|Superiority or Other|||||||0.7813|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.|||
1718925|NCT00711516|3165177|Superiority or Other|||||||0.9642|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.|||
1718926|NCT00711516|3165177|Superiority or Other|||||||0.917|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.|||
1718927|NCT00711516|3165178|Superiority or Other||||||<|0.0001|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.|||
1718928|NCT00711516|3165178|Superiority or Other||||||<|0.603|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.|||
1718929|NCT00711516|3165179|Superiority or Other|||||||0.8876|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.|||
1718930|NCT00711516|3165179|Superiority or Other|||||||0.0692|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's Z-transformation.|||
1718931|NCT00711516|3165180|Superiority or Other|||||||0.1634|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.|||
1718932|NCT00711516|3165180|Superiority or Other|||||||0.1169|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.|||
1718933|NCT00711516|3165181|Superiority or Other|||||||0.5671|||||||Pearson's Correlation Coefficient||||
1718934|NCT00711516|3165181|Superiority or Other|||||||0.2727|||||||Pearson's Correlation Coefficient||||
1718935|NCT00711516|3165182|Superiority or Other|||||||0.0754|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.|||
1718936|NCT00711516|3165182|Superiority or Other|||||||0.0573|||||||Pearson's Correlation Coefficient|The SAS CORR procedure was used to analyze the activation performance relationships. All estimations are based on Fisher's z-transformation.||Pearson's correlation coefficient was used to assess the relationship between fMRI variable and performance on the 2-back working memory test|
1718937|NCT00711516|3165183|Superiority or Other||Median Difference (Net)|11.825||||0.4738|2-Sided|95.0|-12.601|37.987|||Wilcoxon (Mann-Whitney)||||
1718938|NCT00711516|3165184|Superiority or Other||Median Difference (Net)|1.282||||0.8861|2-Sided|95.0|-11.46|14.77|||Wilcoxon (Mann-Whitney)||||
1718939|NCT00711516|3165185|Superiority or Other||Median Difference (Net)|0.086||||1|2-Sided|95.0|-19.195|25.043|||Wilcoxon (Mann-Whitney)||||
1718940|NCT00711516|3165186|Superiority or Other||Median Difference (Net)|-4.026||||0.7382|2-Sided|95.0|-21.684|19.98|||Wilcoxon (Mann-Whitney)||||
1718941|NCT00711516|3165187|Superiority or Other||Mean Difference (Net)|6.2||||0.1246|2-Sided|95.0|-1.8|14.3||P-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as a covariate.|ANCOVA||||
1718942|NCT00711516|3165188|Superiority or Other|||||||0.7343|||||||Fisher Exact||||
1718943|NCT00711516|3165189|Superiority or Other||Mean Difference (Net)|-2.9||||0.0499|2-Sided|95.0|-5.8|0.0||Nominal P-value for treatment comparison is from an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline value as covariate.|ANCOVA|||Hierarchical testing procedure was used to control the studywise error rate at 0.05. If treatment was statistically significant on the primary variable, the key secondary variable would be claimed as significant if p-value was <= 0.05. If primary and key secondary variables were significant subsequent secondary variables following the order presented here would be claimed as significant if their p-values were <= 0.05. If any were >0.05 subsequent p-values would be reported as nominal p-values.|
1718944|NCT00711516|3165190|Superiority or Other||Median Difference (Net)|-0.2||||0.0609|2-Sided|95.0|-0.3|0.0|||Wilcoxon (Mann-Whitney)||||
1718945|NCT00711516|3165191|Superiority or Other||Median Difference (Net)|0.0||||0.1704|2-Sided|95.0|-0.1|0.0|||Wilcoxon (Mann-Whitney)||||
1718946|NCT00711516|3165192|Superiority or Other||Median Difference (Net)|6410.3||||0.0193|2-Sided|95.0|1064.7|12087.3|||Wilcoxon (Mann-Whitney)||||
1718947|NCT00711516|3165193|Superiority or Other||Median Difference (Net)|-335.5||||0.4544|2-Sided|95.0|-1270.7|723.3|||Wilcoxon (Mann-Whitney)||||
1718948|NCT00711516|3165194|Superiority or Other||Median Difference (Net)|0.0||||0.9619|2-Sided|95.0|-18.0|17.0|||Wilcoxon (Mann-Whitney)||||
1718949|NCT00711516|3165195|Superiority or Other||Median Difference (Net)|4.0||||0.6103|2-Sided|95.0|-13.0|19.0|||Wilcoxon (Mann-Whitney)||||
1718950|NCT00711516|3165196|Superiority or Other||Median Difference (Net)|0.0||||0.7115|2-Sided|95.0|-8.0|9.0|||Wilcoxon (Mann-Whitney)||||
1718951|NCT00711516|3165197|Superiority or Other||Median Difference (Net)|0.0||||0.2456|2-Sided|95.0|-8.0|0.0|||Wilcoxon (Mann-Whitney)||||
1718952|NCT00711516|3165198|Superiority or Other||Median Difference (Net)|252.8||||0.6907|2-Sided|95.0|-1066.5|1523.8|||Wilcoxon (Mann-Whitney)||||
1718953|NCT00711516|3165199|Superiority or Other||Median Difference (Net)|90.1||||0.861|2-Sided|95.0|-806.7|707.0|||Wilcoxon (Mann-Whitney)||||
1718954|NCT00711516|3165200|Superiority or Other||Median Difference (Net)|78.9||||0.5774|2-Sided|95.0|-157.8|311.3|||Wilcoxon (Mann-Whitney)||||
1718955|NCT00711516|3165201|Superiority or Other||Median Difference (Net)|53.2||||0.1661|2-Sided|95.0|-17.8|136.1|||Wilcoxon (Mann-Whitney)|||The statistical hypothesis for this key secondary efficacy variable was to be tested using the same model as specified for the primary objective efficacy variable (ANCOVA, ANOVA, and Wilcoxon as appropriate). All statistical tests were 2 tailed at the 0.05 level of significance.|
1718956|NCT00711516|3165202|Superiority or Other||Median Difference (Net)|-241.8||||0.7382|2-Sided|95.0|-2470.0|2102.3||The hierarchical testing procedure was employed to control the studywise error rate at 0.05.|Wilcoxon (Mann-Whitney)|The assumption of normality was violated (p-value ≤0.05), therefore the treatment comparison was made using a Wilcoxon rank-sum test.||Using the standardized difference of 1.10, 28 evaluable patients (14 per treatment group) were required to provide 80% power while controlling the 2-sided, Type 1 error rate at 0.05. With an estimated 25% attrition rate, a total of 38 patients (19 per group) were planned. First analyzed using ANCOVA,the residuals were used to test for normality using Shapiro-Wilk; normality was violated therefore treatment comparison used the Wilcoxon rank sum.|
1718957|NCT00711477|3165209|Superiority or Other||Mean Difference (Final Values)|0.44|||||2-Sided|90.0|0.31|0.57|||||||
1718958|NCT00711477|3165210|Superiority or Other||Mean Difference (Final Values)|1.3|||||2-Sided|90.0|0.95|1.65|||||||
1718959|NCT00711477|3165211|Superiority or Other||Mean Difference (Final Values)|0.99|||||2-Sided|90.0|0.74|1.24|||||||
1718960|NCT00711477|3165212|Superiority or Other||Median Difference (Final Values)|0.75|||||2-Sided|90.0|0.5|1.0|||||||
1718961|NCT00711477|3165213|Superiority or Other||Mean Difference (Final Values)|0.6|||||2-Sided|90.0|0.4|0.8|||||||
1718962|NCT00711477|3165214|Superiority or Other||Mean Difference (Net)|-9.4||||0.16||95.0|-22.7|3.89|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline|||
1718963|NCT00711477|3165215|Superiority or Other||Mean Difference (Net)|-2.48||||0.102|2-Sided|95.0|-5.48|0.51|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline|||
1718964|NCT00711477|3165216|Superiority or Other||Mean Difference (Net)|-1.36||||0.094|2-Sided|95.0|-2.96|0.24|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline|||
1718965|NCT00711477|3165217|Superiority or Other||Mean Difference (Net)|-1.64||||0.139|2-Sided|95.0|-3.84|0.56|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline|||
1718966|NCT00711477|3165218|Superiority or Other||Mean Difference (Net)|-0.4||||0.744|2-Sided|95.0|-2.87|2.07|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline|||
1718967|NCT00711477|3165219|Superiority or Other||Mean Difference (Net)|-0.56||||0.38|2-Sided|95.0|-1.83|0.72|||ANCOVA|Type III sums of squares from ANCOVA model: Treatment and Baseline|||
1718969|NCT00711269|3165245|Superiority|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.6||||0.292|2-Sided|95.0|-4.6|1.4|||ANOVA||||
1718970|NCT00711269|3165245|Superiority|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.2||||0.847|2-Sided|95.0|-2.7|2.2|||ANOVA||||
1718971|NCT00711269|3165245|Superiority|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.4||||0.251|2-Sided|95.0|-3.9|1.0|||ANOVA||||
1718972|NCT00711269|3165246|Superiority|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.352|2-Sided|95.0|-2.3|0.8|||ANOVA||||
1718973|NCT00711269|3165246|Superiority|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.256|2-Sided|95.0|-2.0|0.5|||ANOVA||||
1718974|NCT00711269|3165246|Superiority|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.7||||0.289|2-Sided|95.0|-2.0|0.6|||ANOVA||||
1718975|NCT00711269|3165247|Superiority|One-way Analysis of variance (ANOVA)|LS Mean difference|-2.3||||0.016|2-Sided|95.0|-4.1|-0.4|||ANOVA||||
1718976|NCT00711269|3165247|Superiority|One-way Analysis of variance (ANOVA)|LS Mean difference|-0.8||||0.287|2-Sided|95.0|-2.3|0.7|||ANOVA||||
1718977|NCT00711269|3165247|Superiority|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.4||||0.069|2-Sided|95.0|-2.9|0.1|||ANOVA||||
1718978|NCT00711269|3165248|Superiority|Maximum Contrast Method||||||0.235||||||Contrast Factors (Placebo, SM-13496 40-mg, SM-13496 80-mg): (-1, 0, 1) Adjusted P Value: 0.298|Maximum Contrast Method|Contrast (Placebo, SM-13496 40-mg, SM-13496 80-mg):(-2, 1, 1) Raw P Value: 0.108 Adjusted P Value: 0.145|||
1718979|NCT00711269|3165248|Superiority|One-way Analysis of variance (ANOVA)|LS Mean difference|-4.6||||0.122|2-Sided|95.0|-10.5|1.2|||ANOVA||||
1718980|NCT00711269|3165248|Superiority|One-way Analysis of variance (ANOVA)|LS Mean difference|-1.8||||0.462|2-Sided|95.0|-6.6|3.0|||ANOVA||||
1718981|NCT00711269|3165248|Superiority|One-way Analysis of Variance (ANOVA)|LS Mean difference|-3.5||||0.149|2-Sided|95.0|-8.4|1.3|||ANOVA||[Not specified]||
1718982|NCT00711009|3165359|Non-Inferiority or Equivalence|The exact 95% confidence interval for the difference in response rates (LPV/r + RAL minus LPV/r + FTC/TDF) was used to assess non-inferiority. The LPV/r+RAL arm was considered non-inferior to the LPV/r+FTC/TDF arm because the lower limit of the confidence interval was >/= -20%. Because the LPV/r+RAL arm was considered non-inferior based on the 20% margin, the results were assessed on a more rigorous 12% margin (-12%), as prespecified.|Diff. in Percentage of Subj. Responding|-1.6||||0.85|2-Sided|95.0|-12.0|8.8|||exact binomial method|||The null hypothesis was that the response rate for the LPV/r + RAL arm was more than 20% lower than the response rate for the LPV/r + FTC/TDF arm. The planned sample size of 100 participants per treatment group provided 90% power to conclude that the LPV/r + RAL arm was non-inferior to the control arm, based on a non-inferiority margin of –20% (with a type I error rate of 0.05).|
1718983|NCT00710840|3165377|Superiority or Other|||||||0.41||||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided||||
1718984|NCT00710840|3165378|Superiority or Other|||||||0.48||||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided||||
1718985|NCT00710840|3165379|Superiority or Other|||||||0.92||||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided||||
1718986|NCT00710840|3165380|Superiority or Other|||||||0.07||||||Difference in the change from Preop to 4 weeks Postop|t-test, 2 sided|||The primary outcome, difference in quadriceps torque between intervention (TKA Min) and Control TKA at 4 weeks, was tested using an analysis of covariance model. Confirmatory measures were evaluated at 4 and 12 weeks after surgery in the same way. Baseline characteristics of the treatment groups were compared using 2-sample t tests for continuous measures or a χ2 test for independent proportions for categorical measures. A 2-sided α level of .05 was designated for statistical significance.|
1718987|NCT00710749|3165388|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed rank test||||
1718988|NCT00710749|3165388|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed rank test||||
1718989|NCT00710749|3165388|Superiority or Other||||||<|0.44|||||||Wilcoxon signed rank test||||
1718990|NCT00710684|3165398|Superiority or Other||Mean Difference (Net)|0.4||||0.268|2-Sided|95.0|-0.3|1.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48|
1718991|NCT00710684|3165398|Superiority or Other||Mean Difference (Net)|-0.1||||0.782|2-Sided|95.0|-1.0|0.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48|
1718992|NCT00710684|3165398|Superiority or Other||Mean Difference (Net)|0.4||||0.134|2-Sided|95.0|-0.1|1.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24|
1718993|NCT00710684|3165398|Superiority or Other||Mean Difference (Net)|0.0||||0.962|2-Sided|95.0|-0.6|0.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24|
1718994|NCT00710684|3165399|Superiority or Other||Mean Difference (Net)|1.9||||0.088|2-Sided|95.0|-0.3|4.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48|
1718995|NCT00710684|3165399|Superiority or Other||Mean Difference (Net)|0.5||||0.705|2-Sided|95.0|-1.9|2.9|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48|
1718996|NCT00710684|3165399|Superiority or Other||Mean Difference (Net)|1.9||||0.037|2-Sided|95.0|0.1|3.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36|
1718997|NCT00710684|3165399|Superiority or Other||Mean Difference (Net)|-0.1||||0.944|2-Sided|95.0|-2.1|2.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo ate Week 36|
1718998|NCT00710684|3165399|Superiority or Other||Mean Difference (Net)|2.0||||0.024|2-Sided|95.0|0.3|3.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24|
1719114|NCT00709852|3165531|Superiority or Other||Difference|19.4||||0.0004|||||||McNemar||||
1719115|NCT00709852|3165532|Superiority or Other||Difference|6.5||||0.0006|||||||McNemar||||
1718999|NCT00710684|3165399|Superiority or Other||Mean Difference (Net)|1.4||||0.11|2-Sided|95.0|-0.3|3.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24|
1719000|NCT00710684|3165399|Superiority or Other||Mean Difference (Net)|1.7||||0.019|2-Sided|95.0|0.3|3.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12|
1719001|NCT00710684|3165399|Superiority or Other||Mean Difference (Net)|0.6||||0.396|2-Sided|95.0|-0.8|2.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12|
1719002|NCT00710684|3165400|Superiority or Other||Mean Difference (Net)|2.6||||0.161|2-Sided|95.0|-1.0|6.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48|
1719003|NCT00710684|3165400|Superiority or Other||Mean Difference (Net)|-2.1||||0.292|2-Sided|95.0|-6.0|1.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48|
1719004|NCT00710684|3165400|Superiority or Other||Mean Difference (Net)|2.1||||0.238|2-Sided|95.0|-1.4|5.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36|
1719005|NCT00710684|3165400|Superiority or Other||Mean Difference (Net)|-0.9||||0.634|2-Sided|95.0|-4.4|2.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36|
1719006|NCT00710684|3165400|Superiority or Other||Mean Difference (Net)|0.6||||0.596|2-Sided|95.0|-1.7|3.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12|
1719007|NCT00710684|3165400|Superiority or Other||Mean Difference (Net)|-1.3||||0.337|2-Sided|95.0|-4.0|1.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12|
1719008|NCT00710684|3165401|Superiority or Other||Mean Difference (Net)|-0.1||||0.787|2-Sided|95.0|-0.5|0.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48|
1719009|NCT00710684|3165401|Superiority or Other||Mean Difference (Net)|0.3||||0.19|2-Sided|95.0|-0.2|0.8|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48|
1719010|NCT00710684|3165401|Superiority or Other||Mean Difference (Net)|-0.2||||0.336|2-Sided|95.0|-0.6|0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36|
1719011|NCT00710684|3165401|Superiority or Other||Mean Difference (Net)|0.2||||0.439|2-Sided|95.0|-0.3|0.6|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36|
1719012|NCT00710684|3165401|Superiority or Other||Mean Difference (Net)|-0.3||||0.018|2-Sided|95.0|-0.5|-0.1|||MMRM|||SB-742457 35 mg versus placebo at Week 12|
1719013|NCT00710684|3165401|Superiority or Other||Mean Difference (Net)|-0.1||||0.387|2-Sided|95.0|-0.4|0.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12|
1719014|NCT00710684|3165402|Superiority or Other||Mean Difference (Net)|-1.6||||0.024|2-Sided|95.0|-3.1|-0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 48|
1719015|NCT00710684|3165402|Superiority or Other||Mean Difference (Net)|-0.1||||0.925|2-Sided|95.0|-1.6|1.5|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 48|
1719016|NCT00710684|3165402|Superiority or Other||Mean Difference (Net)|-1.2||||0.057|2-Sided|95.0|-2.5|0.0|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 36|
1719017|NCT00710684|3165402|Superiority or Other||Mean Difference (Net)|0.0||||0.947|2-Sided|95.0|-1.3|1.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 36|
1719018|NCT00710684|3165402|Superiority or Other||Mean Difference (Net)|-1.3||||0.006|2-Sided|95.0|-2.2|-0.4|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 12|
1719019|NCT00710684|3165402|Superiority or Other||Mean Difference (Net)|-0.2||||0.631|2-Sided|95.0|-1.2|0.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 12|
1719020|NCT00710684|3165403|Superiority or Other||Mean Difference (Net)|-0.5||||0.776|2-Sided|95.0|-3.6|2.7|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24|
1719021|NCT00710684|3165403|Superiority or Other||Mean Difference (Net)|-2.4||||0.174|2-Sided|95.0|-5.8|1.1|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24|
1719022|NCT00710684|3165404|Superiority or Other||Mean Difference (Net)|-0.1||||0.462|2-Sided|95.0|-0.5|0.2|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35 mg versus placebo at Week 24|
1719023|NCT00710684|3165404|Superiority or Other||Mean Difference (Net)|-0.1||||0.711|2-Sided|95.0|-0.4|0.3|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15 mg versus placebo at Week 24|
1719024|NCT00710684|3165405|Superiority or Other||Mean Difference (Net)|-1.5||||0.012|2-Sided|95.0|-2.7|-0.3|||MMRM|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 35mg versus placebo at Week 24|
1719116|NCT00709852|3165533|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|-1.6||||||95.0|-10.1|6.9|||||||
1719025|NCT00710684|3165405|Superiority or Other||Mean Difference (Net)|-0.7||||0.279|2-Sided|95.0|-1.9|0.5|||mixed model for repeated measures (MMRM)|The MMRM model included fixed categorical terms for treatment, visit, treatment by visit interaction and country.||SB-742457 15mg versus placebo at Week 24|
1719026|NCT00710593|3165410|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1719027|NCT00710593|3165411|Superiority or Other||Odds Ratio (OR)|1.05||||0.0012|2-Sided|95.0|1.0|1.1|||Regression, Logistic||||
1719028|NCT00710593|3165412|Superiority or Other||Odds Ratio (OR)|1.04||||0.0004|2-Sided|95.0|1.02|1.1|||Regression, Logistic||||
1719029|NCT00710593|3165413|Superiority or Other||Overall aquisition rate|8.1||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact||||
1719030|NCT00710593|3165414|Superiority or Other||Overall aquisition rate|6.3||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact||||
1719031|NCT00710593|3165415|Superiority or Other||Overall aquistion rate|3.6||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact||||
1719032|NCT00710593|3165416|Superiority or Other||Overall aquisition rate|8.3||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact||||
1719033|NCT00710593|3165417|Superiority or Other||Overall aquisition rate|4.5||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact||||
1719034|NCT00710593|3165418|Superiority or Other||Overall aquisition rate|2.0||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact||||
1719035|NCT00710593|3165419|Superiority or Other||Overall aquisition rate|1.6||||1||95.0||||P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|Fisher Exact||||
1719036|NCT00710593|3165420|Superiority or Other||Overall aquisition rate|7.9||||1||95.0|||||Fisher Exact|P-value is from the Fisher's Exact test to compare the proportion of HPV positive between two study groups.|||
1719037|NCT00710593|3165428|Superiority or Other||% of participants with at least 1 event|46.7||||0.8305|2-Sided|||||The p-value is to test the proportions of subjects with at least one event among Group B during the study at Entry, Week 8 and Week 24 after vaccine was administered.|Chi-squared, Corrected||||
1719038|NCT00710593|3165428|Superiority or Other||% of participants with at least 1 event|49.3||||0.8305|2-Sided|95.0||||The p-value is to test the proportions of subjects with at least one event among Group A during the study at Entry, Week 8 and Week 24 after vaccine was administered.|Chi-squared, Corrected||||
1719039|NCT00710593|3165429|Superiority or Other||% of participants who were responders|92.5||||0.0006|2-Sided|95.0|83.4|97.5|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.|
1719040|NCT00710593|3165430|Superiority or Other||% of participants who were responders|96.1||||0.0427|2-Sided|95.0|86.5|99.5|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.|
1719041|NCT00710593|3165431|Superiority or Other||% of participants who were responders|96.8||||0.0534|2-Sided|95.0|89.0|99.9|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.|
1719042|NCT00710593|3165432|Superiority or Other||% of participants who were responders|97.5||||0.1613|2-Sided|95.0|86.8|99.9|||Fisher Exact|||Historical comparison group can be referenced in: Villa et al. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18; Vaccine 24 (2006):5571-5583. PMID 16753240.|
1719043|NCT00710554|3165435|Superiority or Other||Estimated mean treatment difference|-0.38||||0.112|2-Sided|95.0|-0.85|0.09|||ANCOVA|||The model used for the analysis of the end of study value was an ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The null hypothesis was one of no difference between treatments.|
1719044|NCT00710554|3165436|Superiority or Other||Median Difference (Final Values)|-0.75|Standard Error of the Mean|2.459||0.76|2-Sided|95.0|-5.6|4.09|||ANCOVA|||The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.|
1719045|NCT00710554|3165437|Superiority or Other||Estimated mean treatment difference|-0.01||||0.617|2-Sided|95.0|-0.06|0.04|||ANCOVA|||The change from baseline in mean EuroQol-5D score was compared between treatment groups and centres using ANCOVA. The model included treatment and centre groups as factors and baseline mean usage as a covariate.|
1719046|NCT00710554|3165438|Superiority or Other||Estimated mean treatment difference|-0.25||||0.288|2-Sided|95.0|-0.72|0.21|||ANCOVA|||The change from baseline in mean Brief Pain Inventory (short form) score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.|
1719047|NCT00710554|3165439|Superiority or Other||Odds Ratio (OR)|1.762||||0.023|2-Sided|95.0|1.08|2.88|||Regression, Logistic|||The two treatment groups were compared using ordinal logistic regression and the proportional odds model. The initial model incorporated treatment and centre group as factors. The odds ratio together with its 95% CI and associated p-value are presented.|
1719048|NCT00710554|3165440|Superiority or Other||Estimated mean treatment difference|-0.14||||0.233|2-Sided|95.0|-0.37|0.09|||ANCOVA|||The change in the punctate allodynia pain threshold force from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.|
1719049|NCT00710554|3165441|Superiority or Other||Estimated mean treatment difference|0.08||||0.795|2-Sided|95.0|-0.52|0.68|||ANCOVA|||The change in the dynamic allodynia pain score from baseline to the end of treatment was analysed using ANCOVA with the baseline value as a covariate and country and treatment group as factors.|
1720027|NCT00699907|3167268|Superiority or Other||||||>|0.0006|||||||Wilcoxon Rank Sum Test||||
1719050|NCT00710554|3165442|Superiority or Other||Estimated mean treatment difference|-0.83||||0.007|2-Sided|95.0|-1.43|-0.23|||ANCOVA|||The change from baseline score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.|
1719051|NCT00710554|3165443|Superiority or Other||Estimated mean treatment difference|-2.86||||0.198|2-Sided|95.0|-7.22|1.5|||ANCOVA|||The change from baseline in mean Neuropathic Pain Scale score was compared between treatment groups and centres using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.|
1719052|NCT00710554|3165444|Superiority or Other||estimated mean treatment difference|-0.34||||0.139|2-Sided|95.0|-0.79|0.11|||ANCOVA|||The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. Due to the low power of the test for interaction, the test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.|
1719053|NCT00710424|3165445|Superiority or Other||Odds Ratio (OR)|0.857||||0.521|2-Sided|95.0|0.537|1.37|||Regression, Logistic|||The numbers of responders were to be analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio.|
1719054|NCT00710424|3165448|Superiority or Other||estimated mean treatment difference|-0.17||||0.41|2-Sided|95.0|-0.59|0.24|||ANCOVA|||The model used for the analysis of the end of study value was ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments. A negative difference in adjusted means indicates an improvement in favour of Sativex.|
1719055|NCT00710424|3165449|Superiority or Other||Median Difference (Final Values)|-0.01|Standard Error of the Mean|0.021||0.523|2-Sided|95.0|-0.06|0.03|||ANCOVA|||The change from baseline in weighted health state index score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline symptom score as a covariate.|
1719056|NCT00710424|3165450|Superiority or Other||estimated mean treatment difference|-0.05||||0.841|2-Sided|95.0|-0.51|0.42|||ANCOVA|||The change from baseline in mean brief pain inventory (short form) composite score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.|
1719057|NCT00710424|3165451|Superiority or Other||Odds Ratio (OR)|1.301||||0.219|2-Sided|95.0|0.855|1.981|||Regression, Logistic|||In the analysis of Subject Global Impression of Change, the two treatment groups were compared using ordinal logistic regression and the proportional odds model. The model incorporated centre group as a factor.|
1719058|NCT00710424|3165452|Superiority or Other||Estimated mean treatment difference|-0.45||||0.139|2-Sided|95.0|-1.04|0.15|||ANCOVA|||The change from baseline in mean sleep quality numerical rating scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.|
1719059|NCT00710424|3165453|Superiority or Other||Estimated mean treatment difference|0.37|Standard Error of the Mean|2.153||0.865|2-Sided|95.0|-3.87|4.61|||ANCOVA|||The change from baseline in mean neuropathic pain scale scale score at the end of treatment was to be compared between treatment groups using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.|
1719060|NCT00710424|3165454|Superiority or Other||estimated treatment effect|-0.12||||0.634|2-Sided|95.0|-0.6|0.36|||ANCOVA||A negative difference in treatment effect indicates an improvement in pain in favour of Sativex.|The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.|
1719061|NCT00710021|3165467|Superiority or Other|||||||0.1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Cochran-Mantel-Haenszel|Note that none of the Grade 3 or above events were considered by the investigators to be related to study treatment.|||
1719062|NCT00710021|3165468|Superiority or Other|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719063|NCT00710021|3165469|Superiority or Other|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719064|NCT00710021|3165470|Superiority or Other|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719065|NCT00710021|3165471|Superiority or Other|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719066|NCT00710021|3165472|Superiority or Other|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719067|NCT00710021|3165473|Superiority or Other|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719068|NCT00710021|3165474|Superiority or Other|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719069|NCT00710021|3165475|Superiority or Other|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719070|NCT00710021|3165476|Superiority or Other|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719071|NCT00710021|3165477|Superiority or Other|||||||0.62||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline SELENA-SLEDAI score.|||
1719072|NCT00710021|3165478|Superiority or Other|||||||1||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719073|NCT00710021|3165479|Superiority or Other|||||||0.86||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719074|NCT00710021|3165480|Superiority or Other|||||||0.65||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.|||
1719075|NCT00710021|3165481|Superiority or Other|||||||0.59||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C4 level.|||
1719076|NCT00710021|3165482|Superiority or Other|||||||0.67||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.|||
1719077|NCT00710021|3165483|Superiority or Other|||||||0.96||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline serum C3 level.|||
1719078|NCT00710021|3165484|Superiority or Other|||||||0.014||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.|||
1719079|NCT00710021|3165485|Superiority or Other|||||||0.29||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Mx1 expression.|||
1719080|NCT00710021|3165486|Superiority or Other|||||||0.05||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.|||
1719081|NCT00710021|3165487|Superiority or Other|||||||0.28||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifi44 expression.|||
1719082|NCT00710021|3165488|Superiority or Other|||||||0.019||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.|||
1719083|NCT00710021|3165489|Superiority or Other|||||||0.31||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|F-tests derived from the GLM|The test was for the comparison of pooled Vitamin D versus Placebo after adjustment for baseline Ifit1 expression.|||
1719084|NCT00710021|3165490|Superiority or Other|||||||0.12||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719085|NCT00710021|3165491|Superiority or Other|||||||0.047||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719086|NCT00710021|3165492|Superiority or Other|||||||0.038||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719087|NCT00710021|3165493|Superiority or Other|||||||0.53||||||The p-value compares the Placebo with the pooled Vitamin D treatment group.|Fisher Exact||||
1719088|NCT00709956|3165501|Superiority or Other||Difference in least squares mean|-1.5||||0.7883|2-Sided|95.0|-12.3|9.4||If the primary endpoint reaches significance, treatment effect of the secondary endpoint is determined at a 2-sided nominal of 0.05. Since hierarchy of the endpoints to be tested has been predefined, no correction for multiple testing will be applied|Generalized linear model|Subject (sequence), treatment, and period as fixed effect||With a sample size of at least 63 patients and based on the assumptions on the primary endpoint (normal distribution, SD of the difference of 30 m) the study was designed to detect a significant treatment effect with 90% power, assuming a difference exceeding 12.5 m between the mean values of the 6MWD following the iloprost power 15 treatment and the one following the placebo treatment.|
1719089|NCT00709852|3165505|Superiority or Other||Mean Difference (Final Values)|2.4|Standard Deviation|26.6|||||||||||||
1719090|NCT00709852|3165506|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Deviation|1.06|||||||||||||
1719091|NCT00709852|3165508|Superiority or Other||||||<|0.0001||||||for all three readers|t-test, 2 sided||||
1719092|NCT00709852|3165509|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Deviation|0.39|||||||||||||
1719093|NCT00709852|3165510|Superiority or Other||Mean Difference (Final Values)|0.73|Standard Deviation|0.89|<|0.0001|||||||paired t test||||
1719094|NCT00709852|3165511|Superiority or Other||Mean Difference (Final Values)|0.76|Standard Deviation|0.93|<|0.0001|||||||paired t test||||
1719095|NCT00709852|3165512|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Deviation|0.48|||||||||||||
1719096|NCT00709852|3165513|Superiority or Other||Mean Difference (Final Values)|0.57|Standard Deviation|0.58|<|0.0001|||||||paired t test||||
1719097|NCT00709852|3165514|Superiority or Other||Mean Difference (Final Values)|0.57|Standard Deviation|0.56|<|0.0001|||||||paired t test||||
1719098|NCT00709852|3165515|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|0.5||||||95.0|-0.5|1.5|||||||
1719099|NCT00709852|3165516|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|1.1||||||95.0|-1.0|3.2|||||||
1719100|NCT00709852|3165517|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|0.7||||||95.0|-0.3|1.6|||||||
1719101|NCT00709852|3165518|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|0.0||||||95.0|-1.4|1.4|||||||
1719102|NCT00709852|3165519|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|6.5||||||95.0|1.5|11.4|||||||
1719103|NCT00709852|3165520|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|2.1||||||95.0|0.2|3.9|||||||
1719104|NCT00709852|3165521|Superiority or Other||Difference|1.0||||0.1573|||||||McNemar||||
1719105|NCT00709852|3165522|Superiority or Other||Difference|20.4|||<|0.0001|||||||McNemar||||
1719106|NCT00709852|3165523|Superiority or Other||Difference|7.2|||<|0.0001|||||||McNemar||||
1719107|NCT00709852|3165524|Superiority or Other||Difference|0.5||||0.7055|||||||McNemar||||
1719108|NCT00709852|3165525|Superiority or Other||Difference|12.9||||0.0186|||||||McNemar||||
1719109|NCT00709852|3165526|Superiority or Other||Difference|4.5||||0.0236|||||||McNemar||||
1719110|NCT00709852|3165527|Superiority or Other||Difference|1.5||||0.0833|||||||McNemar||||
1719111|NCT00709852|3165528|Superiority or Other||Difference|21.5|||<|0.0001|||||||McNemar||||
1719112|NCT00709852|3165529|Superiority or Other||Difference|7.9|||<|0.0001|||||||McNemar||||
1719117|NCT00709852|3165534|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|0.5||||||95.0|-2.7|3.6|||||||
1719118|NCT00709852|3165535|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|0.0||||||95.0|-3.1|3.1|||||||
1719119|NCT00709852|3165536|Superiority or Other||Difference|1.6||||0.763|||||||McNemar||||
1719120|NCT00709852|3165537|Superiority or Other||Difference|13.1||||0.0001|||||||McNemar||||
1719121|NCT00709852|3165538|Superiority or Other||Difference|10.5||||0.0002|||||||McNemar||||
1719122|NCT00709852|3165539|Superiority or Other||Difference|0.0||||1|||||||McNemar||||
1719123|NCT00709852|3165540|Superiority or Other||Difference|13.6|||<|0.0001|||||||McNemar||||
1719124|NCT00709852|3165541|Superiority or Other||Difference|10.5||||0.0002|||||||McNemar||||
1719125|NCT00709852|3165542|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|0.7||||||95.0|-0.3|1.6|||||||
1719126|NCT00709852|3165543|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|-0.4||||||95.0|-3.8|2.9|||||||
1719127|NCT00709852|3165544|Superiority or Other||Difference|9.2|||<|0.0001|||||||McNemar||||
1719128|NCT00709852|3165545|Superiority or Other||Difference|6.8||||0.0039|||||||McNemar||||
1719129|NCT00709852|3165546|Superiority or Other||Difference|9.9|||<|0.0001|||||||McNemar||||
1719130|NCT00709852|3165547|Superiority or Other||Difference|6.2||||0.0082|||||||McNemar||||
1719131|NCT00709852|3165548|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.05||||||95.0|0.006|0.098||||||analysis for internal morphology|
1719132|NCT00709852|3165548|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.1||||||95.0|0.03|0.161||||||analysis for border delineation|
1719133|NCT00709852|3165548|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.1||||||95.0|0.042|0.153||||||analysis for contrast enhancement|
1719134|NCT00709852|3165549|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01||||||95.0|-0.015|0.035||||||analysis for internal morphology|
1719135|NCT00709852|3165549|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|-0.01||||||95.0|-0.04|0.02||||||analysis for border delineation|
1719136|NCT00709852|3165549|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03||||||95.0|-0.009|0.065||||||analysis for contrast enhancement|
1719137|NCT00709852|3165550|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01|Standard Deviation|0.59||||95.0|-0.049|0.078|||||||
1719138|NCT00709852|3165551|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03||||||95.0|0.003|0.055||||||analysis for internal morphology|
1719139|NCT00709852|3165551|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04||||||95.0|0.003|0.071||||||analysis for border delineation|
1719140|NCT00709852|3165551|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.06||||||95.0|0.03|0.096||||||analysis for contrast enhancement|
1719141|NCT00709852|3165552|Superiority or Other||Mean Difference (Final Values)|0.51|Standard Deviation|1.01|<|0.0001||||||for internal morphology|paired t test||||
1719142|NCT00709852|3165552|Superiority or Other||Mean Difference (Final Values)|0.65|Standard Deviation|1.27|<|0.0001||||||for border delineation|paired t test||||
1719143|NCT00709852|3165553|Superiority or Other||Mean Difference (Final Values)|0.63|Standard Deviation|0.49|<|0.0001||||||for internal morphology|paired t test||||
1719144|NCT00709852|3165553|Superiority or Other||Mean Difference (Final Values)|0.78|Standard Deviation|0.61|<|0.0001||||||for border delineation|paired t test||||
1719145|NCT00709852|3165554|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.28|Standard Deviation|3.39||||95.0|-0.087|0.641|||||||
1719146|NCT00709852|3165555|Superiority or Other||Mean Difference (Final Values)|0.58|Standard Deviation|0.63|<|0.0001||||||for internal morphology|paired t test||||
1719147|NCT00709852|3165555|Superiority or Other||Mean Difference (Final Values)|0.71|Standard Deviation|0.76|<|0.0001||||||for border delineation|paired t test||||
1719148|NCT00709852|3165556|Superiority or Other||Mean Difference (Final Values)|0.56|Standard Deviation|0.97|<|0.0001||||||for internal morphology|paired t test||||
1719149|NCT00709852|3165556|Superiority or Other||Mean Difference (Final Values)|0.74|Standard Deviation|1.26|<|0.0001||||||for border delineation|paired t test||||
1719150|NCT00709852|3165557|Superiority or Other||Mean Difference (Final Values)|0.64|Standard Deviation|0.5|<|0.0001||||||for internal morphology|paired t test||||
1719151|NCT00709852|3165557|Superiority or Other||Mean Difference (Final Values)|0.77|Standard Deviation|0.64|<|0.0001||||||for border delineation|paired t test||||
1719152|NCT00709852|3165558|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.29|Standard Deviation|3.21||||95.0|-0.053|0.636|||||||
1719153|NCT00709852|3165559|Superiority or Other||Mean Difference (Final Values)|0.61|Standard Deviation|0.61|<|0.0001||||||for internal morphology|paired t test||||
1719154|NCT00709852|3165559|Superiority or Other||Mean Difference (Final Values)|0.74|Standard Deviation|0.78|<|0.0001||||||for border delineation|paired t test||||
1719155|NCT00709852|3165560|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|8.3||||||95.0|-0.9|17.6|||||||
1719156|NCT00709852|3165561|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|3.6||||||95.0|-5.9|13.1|||||||
1719157|NCT00709852|3165562|Non-Inferiority or Equivalence|noninferiority margin = -10%|Difference in percentages|8.9|||||2-Sided|95.0|-0.5|18.4|||||||
1719158|NCT00709852|3165562|Superiority or Other||Difference in percentages|15.8|||||||||||||for BR3||
1719159|NCT00709852|3165562|Superiority or Other||Difference in percentages|-0.9|||||||||||||for BR2||
1719160|NCT00709852|3165562|Superiority or Other||Difference in percentages|8.3|||||||||||||for BR1||
1719161|NCT00709852|3165563|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.01|Standard Deviation|5.7||||95.0|-0.601|0.622|||||||
1719904|NCT00702468|3166876|Superiority or Other||Odds Ratio (OR)|0.335||||0.013|2-Sided|90.0|0.162|0.691|||Chi-squared||||
1719162|NCT00709852|3165564|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.03|Standard Deviation|0.29||||95.0|-0.006|0.059||||||analysis for internal morphology|
1719163|NCT00709852|3165564|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04|Standard Deviation|0.41||||95.0|-0.009|0.082||||||analysis for border delineation|
1719164|NCT00709852|3165564|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.04|Standard Deviation|0.33||||95.0|0.0004|0.078||||||analysis for contrast enhancement|
1719165|NCT00709852|3165565|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.16|Standard Deviation|6.44|||2-Sided|95.0|-0.532|0.851|||||||
1719166|NCT00709852|3165566|Superiority or Other||Mean Difference (Final Values)|0.58|Standard Deviation|0.41|<|0.0001||||||for internal morphology|paired t test||||
1719167|NCT00709852|3165566|Superiority or Other||Mean Difference (Final Values)|0.56|Standard Deviation|0.48|<|0.0001||||||for border delineation|paired t test||||
1719168|NCT00709852|3165566|Superiority or Other||Mean Difference (Final Values)|1.24|Standard Deviation|0.53|<|0.0001||||||for contrast enhancement|paired t test||||
1719169|NCT00709852|3165567|Superiority or Other||Mean Difference (Final Values)|0.42|Standard Deviation|0.83|<|0.0001||||||for internal morphology|paired t test||||
1719170|NCT00709852|3165567|Superiority or Other||Mean Difference (Final Values)|0.44|Standard Deviation|1.07|<|0.0001||||||for border delineation|paired t test||||
1719171|NCT00709852|3165567|Superiority or Other||Mean Difference (Final Values)|0.78|Standard Deviation|1.06|<|0.0001||||||for contrast enhancement|paired t test||||
1719172|NCT00709852|3165568|Superiority or Other||Mean Difference (Final Values)|0.39|Standard Deviation|0.96|<|0.0001||||||for internal morphology|paired t test||||
1719173|NCT00709852|3165568|Superiority or Other||Mean Difference (Final Values)|0.33|Standard Deviation|0.97|<|0.0001||||||for border delineation|paired t test||||
1719174|NCT00709852|3165568|Superiority or Other||Mean Difference (Final Values)|0.69|Standard Deviation|0.95|<|0.0001||||||for contrast enhancement|paired t test||||
1719175|NCT00709852|3165569|Superiority or Other||Mean Difference (Final Values)|0.48|Standard Deviation|1.11|<|0.0001||||||for internal morphology|paired t test||||
1719176|NCT00709852|3165569|Superiority or Other||Mean Difference (Final Values)|0.54|Standard Deviation|1.44|<|0.0001||||||for border delineation|paired t test||||
1719177|NCT00709852|3165569|Superiority or Other||Mean Difference (Final Values)|0.89|Standard Deviation|1.29|<|0.0001||||||for contrast enhancement|paired t test||||
1719178|NCT00709852|3165570|Superiority or Other||Mean Difference (Final Values)|0.44|Standard Deviation|0.82|<|0.0001||||||for internal morphology|paired t test||||
1719179|NCT00709852|3165570|Superiority or Other||Mean Difference (Final Values)|0.52|Standard Deviation|1.26|<|0.0001||||||for border delineation|paired t test||||
1719180|NCT00709852|3165570|Superiority or Other||Mean Difference (Final Values)|0.83|Standard Deviation|1.16|<|0.0001||||||for contrast enhancement|paired t test||||
1719181|NCT00709852|3165571|Superiority or Other||Mean Difference (Final Values)|0.76|Standard Deviation|0.22|<|0.0001||||||for internal morphology|paired t test||||
1719182|NCT00709852|3165571|Superiority or Other||Mean Difference (Final Values)|0.72|Standard Deviation|0.23|<|0.0001||||||for border delineation|paired t test||||
1719183|NCT00709852|3165571|Superiority or Other||Mean Difference (Final Values)|1.7|Standard Deviation|0.3|<|0.0001||||||for contrast enhancement|paired t test||||
1719184|NCT00709852|3165572|Superiority or Other||Mean Difference (Final Values)|0.43|Standard Deviation|0.32|<|0.0001||||||for internal morphology|paired t test||||
1719185|NCT00709852|3165572|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Deviation|0.33|<|0.0001||||||for border delineation|paired t test||||
1719186|NCT00709852|3165572|Superiority or Other||Mean Difference (Final Values)|1.36|Standard Deviation|0.33|<|0.0001||||||for contrast enhancement|paired t test||||
1719187|NCT00709852|3165573|Superiority or Other||Mean Difference (Final Values)|1.1|Standard Deviation|0.39|<|0.0001||||||for internal morphology|paired t test||||
1719188|NCT00709852|3165573|Superiority or Other||Mean Difference (Final Values)|0.86|Standard Deviation|0.46|<|0.0001||||||for border delineation|paired t test||||
1719189|NCT00709852|3165573|Superiority or Other||Mean Difference (Final Values)|2.13|Standard Deviation|0.62|<|0.0001||||||for contrast enhancement|paired t test||||
1719190|NCT00709852|3165574|Superiority or Other||Mean Difference (Final Values)|0.77|Standard Deviation|0.38|<|0.0001||||||for internal morphology|paired t test||||
1719191|NCT00709852|3165574|Superiority or Other||Mean Difference (Final Values)|0.81|Standard Deviation|0.37|<|0.0001||||||for border delineation|paired t test||||
1719192|NCT00709852|3165574|Superiority or Other||Mean Difference (Final Values)|1.62|Standard Deviation|0.3|<|0.0001||||||for contrast enhancement|paired t test||||
1719193|NCT00709852|3165575|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.17|Standard Deviation|5.68|||2-Sided|95.0|-0.439|0.78||||||AR|
1719194|NCT00709852|3165575|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.56|Standard Deviation|4.07|||2-Sided|95.0|0.125|1.0||||||BR 3|
1719195|NCT00709852|3165575|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|-0.44|Standard Deviation|12.38|||2-Sided|95.0|-1.772|0.885||||||BR 2|
1719196|NCT00709852|3165575|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.39|Standard Deviation|5.51|||2-Sided|95.0|-0.199|0.984||||||BR 1|
1719197|NCT00709852|3165576|Superiority or Other||Mean Difference (Final Values)|0.61|Standard Deviation|0.42|<|0.0001||||||for internal morphology|paired t test||||
1719198|NCT00709852|3165576|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Deviation|0.53|<|0.0001||||||for border delineation|paired t test||||
1719199|NCT00709852|3165576|Superiority or Other||Mean Difference (Final Values)|1.29|Standard Deviation|0.56|<|0.0001||||||for contrast enhancement|paired t test||||
1719200|NCT00709852|3165577|Superiority or Other||Mean Difference (Final Values)|0.41|Standard Deviation|0.52|<|0.0001||||||for internal morphology|paired t test||||
1720016|NCT00699907|3167263|Superiority or Other|||||||0.005|||||||Wilcoxon Rank Sum Test||||
1719201|NCT00709852|3165577|Superiority or Other||Mean Difference (Final Values)|0.43|Standard Deviation|0.5|<|0.0001||||||for border delineation|paired t test||||
1719202|NCT00709852|3165577|Superiority or Other||Mean Difference (Final Values)|1.06|Standard Deviation|0.51|<|0.0001||||||for contrast enhancement|paired t test||||
1719203|NCT00709852|3165578|Superiority or Other||Mean Difference (Final Values)|0.82|Standard Deviation|0.61|<|0.0001||||||for internal morphology|paired t test||||
1719204|NCT00709852|3165578|Superiority or Other||Median Difference (Final Values)|0.72|Standard Deviation|0.78|<|0.0001||||||for border delineation|paired t test||||
1719205|NCT00709852|3165578|Superiority or Other||Mean Difference (Final Values)|1.59|Standard Deviation|0.77|<|0.0001||||||for contrast enhancement|paired t test||||
1719206|NCT00709852|3165579|Superiority or Other||Mean Difference (Final Values)|0.62|Standard Deviation|0.47|<|0.0001||||||for internal morphology|paired t-test||||
1719207|NCT00709852|3165579|Superiority or Other||Mean Difference (Final Values)|0.67|Standard Deviation|0.66|<|0.0001||||||for border delineation|paired t-test||||
1719208|NCT00709852|3165579|Superiority or Other||Mean Difference (Final Values)|1.26|Standard Deviation|0.61|<|0.0001||||||for contrast enhancement|paired t-test||||
1719209|NCT00709761|3165587|Superiority or Other||percentage of participants|53.0||||||95.0|40.7|66.0|||||The estimation parameter represents the percentage of participants experiencing either a CR or a PR.||
1719210|NCT00709735|3165588|Superiority||Mean Difference (Final Values)|-12.7|||||2-Sided|95.0|-27.4|1.9|||||Non-Reactivation Propranolol (NRP) - Reactivation Propranolol (RP)||
1719211|NCT00709735|3165589|Superiority||Mean Difference (Final Values)|-13.0|||||2-Sided|95.0|-30.0|4.0|||||Non-Reactivation Propranolol (NRP) - Reactivation Propranolol (RP)||
1719212|NCT00709618|3165600|Superiority or Other||percentage of participants|41.0|||||2-Sided|95.0|26.4|55.4|||||The estimated value respresents the percentage of participants with a complete response or a partial response.||
1719213|NCT00709228|3165617|Superiority or Other||simple proportion|0.097|||||2-Sided|95.0|0.06|0.15|||||||
1719214|NCT00709111|3165678|Superiority or Other|||||||0.97||||||The p-value is one-sided with a nominal level of 0.05.|Wilcoxon signed-rank, 1-sided|||The change in CD4+ T-cell count from baseline to week 24 was compared against the null hypothesis of change <20 cells/mm^3. The study was powered to yield 80% power to show that there was >=20 cells/mm^3 increase in CD4+ T-cell count assuming an underlying change in CD4+ T-cell counts induced by MVC of 50 cells/mm^3, a standard deviation of 60 cells/mm^3 around the mean CD4+ T-cell count change, 10% lost-to-follow-up or premature MVC discontinuation rate, and one-sided type 1 error of 0.05.|
1719215|NCT00709098|3165679|Superiority or Other||Mean group difference|-5.1|||<|0.0001|2-Sided|95.0|-7.0|-3.1|||t-test, 2 sided||||
1719216|NCT00708721|3165698|Other||Maximum Tolerated Dose|1.0|||||2-Sided||||||||Based on cytopenias observed at day 10 (Phase 1 trial only), and the Phase II dose was determined to be 1 mg per day for 7 consecutive days given on a 28 day cycle.||
1719217|NCT00708643|3165753|Superiority or Other||Mean Difference (Final Values)|-0.241|Standard Error of the Mean|1.6975|||2-Sided|98.75|-0.241|4.0043|||||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides lower levels of corneal staining than the habitual lens.|
1719218|NCT00708643|3165754|Superiority or Other||Mean Difference (Final Values)|-0.8625|Standard Error of the Mean|2.3407|||2-Sided|98.75|-0.8625|5.0524|||||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides a lower level of tarsal hyperemia than the habitual lens.|
1719219|NCT00708643|3165755|Superiority or Other||Mean Difference (Final Values)|1.2596|Standard Error of the Mean|1.1873|||2-Sided|98.75|1.2596|4.2599|||||The mean difference is calculated as narafilcon A minus the habitual lens.||
1719220|NCT00708643|3165756|Superiority or Other||Mean Difference (Final Values)|0.2228|Standard Error of the Mean|1.7002|||2-Sided|99.0|0.2228|4.6564|||||The mean difference is calculated as narafilcon A minus the habitual lens.|The alternative hypothesis is that narafilcon A provides a lowe level of upper lid margin staining than the habitual lens.|
1719221|NCT00708643|3165757|Superiority or Other||Mean Difference (Final Values)|-0.0804|Standard Error of the Mean|0.7605|||2-Sided|99.0|-0.0804|1.8821|||||The mean difference is calculated as narafilcon A minus habitual lens.|The alternative hypothesis is that narafilcon A provides better comfort than the habitual lens by having a lower rating on the scale.|
1719222|NCT00708643|3165758|Superiority or Other||Mean Difference (Final Values)|-3.0047|Standard Error of the Mean|2.2863|||2-Sided|98.75|-3.0047|2.7153|||||The mean difference is calculated as narafilcon A minus the habitual lens.|The alternative hypothesis is that narafilcon A will provide a lower level of limbal hyperemia than the habitual lens.|
1719223|NCT00708552|3165778|Superiority||Mean Difference (Net)|0.3||||0.48|2-Sided|95.0|-0.5|1.1|||Mixed model repeated measures|||Total Independence Score, Placebo Vs Donepezil at Week 24|
1719224|NCT00708552|3165778|Superiority||Mean Difference (Net)|0.2||||0.598|2-Sided|95.0|-0.6|1.0|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-35mg at Week 24|
1719225|NCT00708552|3165778|Superiority||Mean Difference (Net)|0.1||||0.72|2-Sided|95.0|-0.6|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-15mg at Week 24|
1719226|NCT00708552|3165778|Superiority||Mean Difference (Net)|0.3||||0.346|2-Sided|95.0|-0.3|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs Donepezil at Week 12|
1719227|NCT00708552|3165778|Superiority||Mean Difference (Net)|0.3||||0.378|2-Sided|95.0|-0.4|0.9|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-35mg at Week 12|
1719228|NCT00708552|3165778|Superiority||Mean Difference (Net)|0.0||||0.972|2-Sided|95.0|-0.7|0.6|||Mixed model repeated measures|||Total Independence Score, Placebo Vs SB-742457-15mg at Week 12|
1719229|NCT00708552|3165778|Superiority||Mean Difference (Net)|-0.1||||0.92|2-Sided|95.0|-1.9|1.7|||Mixed model repeated measures|||Instrumental Score, Placebo Vs Donepezil at Week 24|
1719230|NCT00708552|3165778|Superiority||Mean Difference (Net)|-0.3||||0.752|2-Sided|95.0|-2.0|1.5|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-35mg at Week 24|
1719231|NCT00708552|3165778|Superiority||Mean Difference (Net)|-0.4||||0.636|2-Sided|95.0|-2.1|1.3|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-15mg at Week 24|
1720017|NCT00699907|3167263|Superiority or Other|||||||0.006|||||||Wilcoxon Rank Sum Test||||
1719232|NCT00708552|3165778|Superiority||Mean Difference (Net)|0.2||||0.802|2-Sided|95.0|-1.3|1.6|||Mixed model repeated measures|||Instrumental Score, Placebo Vs Donepezil at Week 12|
1719233|NCT00708552|3165778|Superiority||Mean Difference (Net)|0.0||||0.946|2-Sided|95.0|-1.3|1.4|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-35mg at Week 12|
1719234|NCT00708552|3165778|Superiority||Mean Difference (Net)|-0.8||||0.292|2-Sided|95.0|-2.2|0.7|||Mixed model repeated measures|||Instrumental Score, Placebo Vs SB-742457-15mg at Week 12|
1719235|NCT00708552|3165778|Superiority||Mean Difference (Net)|-0.1||||0.726|2-Sided|95.0|-0.7|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs Donepezil at Week 24|
1719236|NCT00708552|3165778|Superiority||Mean Difference (Net)|0.1||||0.774|2-Sided|95.0|-0.5|0.7|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-35mg at Week 24|
1719237|NCT00708552|3165778|Superiority||Mean Difference (Net)|0.0||||0.91|2-Sided|95.0|-0.6|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-15mg at Week 24|
1719238|NCT00708552|3165778|Superiority||Mean Difference (Net)|0.3||||0.14|2-Sided|95.0|-0.1|0.8|||Mixed model repeated measures|||Basic Score, Placebo Vs Donepezil at Week 12|
1719239|NCT00708552|3165778|Superiority||Mean Difference (Net)|0.2||||0.5|2-Sided|95.0|-0.4|0.8|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-35mg at Week 12|
1719240|NCT00708552|3165778|Superiority||Mean Difference (Net)|0.0||||0.869|2-Sided|95.0|-0.5|0.5|||Mixed model repeated measures|||Basic Score, Placebo Vs SB-742457-15mg at Week 12|
1719241|NCT00708552|3165779|Superiority||Mean Difference (Net)|0.8||||0.044|2-Sided|95.0|0.0|1.6|||ANCOVA|||MMSE Total score, Placebo Vs Donepezil at Week 24|
1719242|NCT00708552|3165779|Superiority||Mean Difference (Net)|0.3||||0.505|2-Sided|95.0|-0.5|1.1|||ANCOVA|||MMSE Total score, Placebo Vs SB-742457-35mg at Week 24|
1719243|NCT00708552|3165779|Superiority||Mean Difference (Net)|0.0||||0.966|2-Sided|95.0|-0.8|0.8|||ANCOVA|||MMSE Total score, Placebo Vs SB-742457-15mg at Week 24|
1719244|NCT00708552|3165780|Superiority||Mean Difference (Net)|0.3||||0.429|2-Sided|95.0|-0.4|1.0|||ANCOVA|||CSDD Total score, Placebo Vs Donepezil at Week 24|
1719245|NCT00708552|3165780|Superiority||Mean Difference (Net)|0.2||||0.523|2-Sided|95.0|-0.5|0.9|||ANCOVA|||CSDD Total score, Placebo Vs SB-742457-35mg at Week 24|
1719246|NCT00708552|3165780|Superiority||Mean Difference (Net)|-0.2||||0.594|2-Sided|95.0|-0.9|0.5|||ANCOVA|||CSDD Total score, Placebo Vs SB-742457-15mg at Week 24|
1719247|NCT00708552|3165781|Superiority||Mean Difference (Net)|-0.1||||0.896|2-Sided|95.0|-2.3|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs Donepezil at Week 24|
1719248|NCT00708552|3165781|Superiority||Median Difference (Net)|-0.1||||0.919|2-Sided|95.0|-2.2|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-35mg at Week 24|
1719249|NCT00708552|3165781|Superiority||Mean Difference (Net)|-0.3||||0.723|2-Sided|95.0|-2.3|1.6|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-15mg at Week 24|
1719250|NCT00708552|3165781|Superiority||Mean Difference (Net)|0.6||||0.506|2-Sided|95.0|-1.1|2.2|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs Donepezil at Week 12|
1719251|NCT00708552|3165781|Superiority||Mean Difference (Net)|0.3||||0.725|2-Sided|95.0|-1.4|2.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-35mg at Week 12|
1719252|NCT00708552|3165781|Superiority||Mean Difference (Net)|-0.7||||0.417|2-Sided|95.0|-2.4|1.0|||Mixed model repeated measures|||ADCS-ADL Total score, Placebo Vs SB-742457-15mg at Week 12|
1719253|NCT00708552|3165782|Superiority||Mean Difference (Net)|-0.3||||0.082|2-Sided|95.0|-0.5|0.0|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ Total score, Placebo Vs Donepezil at Week 12|
1719254|NCT00708552|3165782|Superiority||Mean Difference (Net)|0.1||||0.55|2-Sided|95.0|-0.2|0.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ Total score, Placebo Vs SB-742457-35mg at Week 12|
1719255|NCT00708552|3165782|Superiority||Mean Difference (Net)|0.1||||0.369|2-Sided|95.0|-0.2|0.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on CIBIC+ score, Placebo Vs SB-742457-15mg at Week 12|
1719256|NCT00708552|3165783|Superiority||Mean Difference (Net)|-0.1||||0.245|2-Sided|95.0|-0.4|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ Total score, Placebo Vs Donepezil at Week 12|
1719257|NCT00708552|3165783|Superiority||Mean Difference (Net)|-0.1||||0.413|2-Sided|95.0|-0.4|0.2|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ Total score, Placebo Vs SB-742457-35mg at Week 12|
1719258|NCT00708552|3165783|Superiority||Mean Difference (Net)|0.1||||0.671|2-Sided|95.0|-0.2|0.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CIBIC+ score, Placebo Vs SB-742457-15mg at Week 12|
1719259|NCT00708552|3165784|Superiority||Mean Difference (Net)|4.7||||0.011|2-Sided|95.0|1.1|8.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs Donepezil at Week 12|
1719260|NCT00708552|3165784|Superiority||Mean Difference (Net)|-0.4||||0.848|2-Sided|95.0|-4.0|3.3|||Mixed Models Analysis|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 12|
1719261|NCT00708552|3165784|Superiority||Mean Difference (Net)|-3.6||||0.053|2-Sided|95.0|-7.3|0.0|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 12|
1719262|NCT00708552|3165784|Superiority||Mean Difference (Net)|-1.2||||0.088|2-Sided|95.0|-2.7|0.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 12|
1719263|NCT00708552|3165784|Superiority||Mean Difference (Net)|-0.2||||0.826|2-Sided|95.0|-1.7|1.4|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 12|
1719264|NCT00708552|3165784|Superiority||Mean Difference (Net)|0.1||||0.908|2-Sided|95.0|-1.5|1.7|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 12|
1719265|NCT00708552|3165785|Superiority||Mean Difference (Net)|4.2||||0.021|2-Sided|95.0|0.6|7.7|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs Donepezil at Week 12|
1719298|NCT00708552|3165793|Superiority||Mean Difference (Net)|2.0||||0.282|2-Sided|95.0|-1.7|5.7|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs Donepezil at Week 24|
1719266|NCT00708552|3165785|Superiority||Mean Difference (Net)|3.1||||0.086|2-Sided|95.0|-0.4|6.7|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 12|
1719267|NCT00708552|3165785|Superiority||Mean Difference (Net)|-0.8||||0.676|2-Sided|95.0|-4.7|3.0|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 12|
1719268|NCT00708552|3165785|Superiority||Mean Difference (Net)|0.1||||0.924|2-Sided|95.0|-1.2|1.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 12|
1719269|NCT00708552|3165785|Superiority||Mean Difference (Net)|0.1||||0.918|2-Sided|95.0|-1.3|1.4|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 12|
1719270|NCT00708552|3165785|Superiority||Mean Difference (Net)|0.2||||0.798|2-Sided|95.0|-1.1|1.5|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 12|
1719271|NCT00708552|3165786|Superiority||Mean Difference (Net)|3.4||||0.031|2-Sided|95.0|0.3|6.4|||Mixed model repeated measures|||RBANS total score, Placebo Vs Donepzil at Week 12|
1719272|NCT00708552|3165786|Superiority||Mean Difference (Net)|0.9||||0.57|2-Sided|95.0|-2.2|4.0|||Mixed model repeated measures|||RBANS total score, Placebo Vs SB-742457-35mg at Week 12|
1719273|NCT00708552|3165786|Superiority||Mean Difference (Net)|-1.9||||0.257|2-Sided|95.0|-5.2|1.4|||Mixed model repeated measures|||RBANS total score, Placebo Vs SB-742457-15mg at Week 12|
1719274|NCT00708552|3165787|Superiority||Mean Difference (Net)|-0.2||||0.059|2-Sided|95.0|-0.4|0.0|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs Donepzil at Week 12|
1719275|NCT00708552|3165787|Superiority||Mean Difference (Net)|0.0||||0.927|2-Sided|95.0|-0.2|0.2|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-35mg at Week 12|
1719276|NCT00708552|3165787|Superiority||Mean Difference (Net)|0.1||||0.32|2-Sided|95.0|-0.1|0.3|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-15mg at Week 12|
1719277|NCT00708552|3165788|Superiority||Mean Difference (Net)|-0.5||||0.443|2-Sided|95.0|-1.6|0.7|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs Donepzil at Week 12|
1719278|NCT00708552|3165788|Superiority||Mean Difference (Net)|-0.1||||0.833|2-Sided|95.0|-1.4|1.1|||Mixed Models Analysis|||ADAS-Cog Total Score, Placebo Vs SB-742457-35mg at Week 12|
1719279|NCT00708552|3165788|Superiority||Mean Difference (Net)|0.1||||0.847|2-Sided|95.0|-1.1|1.4|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-15mg at Week 12|
1719280|NCT00708552|3165789|Superiority||Mean Difference (Net)|-0.3||||0.166|2-Sided|95.0|-0.6|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs Donepezil at Week 24|
1719281|NCT00708552|3165789|Superiority||Mean Difference (Final Values)|-0.1||||0.495|2-Sided|95.0|-0.5|0.2|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs SB-742457-35mg at Week 24|
1719282|NCT00708552|3165789|Superiority||Mean Difference (Final Values)|0.2||||0.295|2-Sided|95.0|-0.2|0.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+, Placebo Vs SB-742457-15mg at Week 24|
1719283|NCT00708552|3165790|Superiority||Mean Difference (Final Values)|-0.2||||0.145|2-Sided|95.0|-0.5|0.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs Donepezil at Week 24|
1719284|NCT00708552|3165790|Superiority||Mean Difference (Final Values)|-0.1||||0.733|2-Sided|95.0|-0.4|0.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs SB-742457-35mg at Week 24|
1719285|NCT00708552|3165790|Superiority||Mean Difference (Final Values)|0.2||||0.146|2-Sided|95.0|-0.1|0.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on CBIC+ score, Placebo Vs SB-742457-15mg at Week 24|
1719286|NCT00708552|3165791|Superiority||Mean Difference (Net)|2.7||||0.246|2-Sided|95.0|-1.9|7.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs Donepezil at Week 24|
1719287|NCT00708552|3165791|Superiority||Mean Difference (Net)|-1.1||||0.667|2-Sided|95.0|-5.9|3.8|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 24|
1719288|NCT00708552|3165791|Superiority||Mean Difference (Net)|-2.1||||0.41|2-Sided|95.0|-7.0|2.9|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 24|
1719289|NCT00708552|3165791|Superiority||Mean Difference (Net)|-0.1||||0.921|2-Sided|95.0|-1.9|1.7|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 24|
1719290|NCT00708552|3165791|Superiority||Mean Difference (Net)|1.3||||0.216|2-Sided|95.0|-0.7|3.2|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 24|
1719291|NCT00708552|3165791|Superiority||Mean Difference (Net)|1.5||||0.138|2-Sided|95.0|-0.5|3.6|||Mixed model repeated measures|||Baseline MMSE score of 10-20 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 24|
1719292|NCT00708552|3165792|Superiority||Mean Difference (Net)|2.4||||0.27|2-Sided|95.0|-1.9|6.8|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs Donepezil at Week 24|
1719293|NCT00708552|3165792|Superiority||Mean Difference (Net)|-1.5||||0.545|2-Sided|95.0|-6.2|3.3|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-35mg at Week 24|
1719294|NCT00708552|3165792|Superiority||Mean Difference (Net)|-1.1||||0.655|2-Sided|95.0|-5.7|3.6|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on RBANS Total score, Placebo Vs SB-742457-15mg at Week 24|
1719295|NCT00708552|3165792|Superiority||Mean Difference (Net)|0.4||||0.63|2-Sided|95.0|-1.1|1.9|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs Donepezil at Week 24|
1719296|NCT00708552|3165792|Superiority||Mean Difference (Net)|1.0||||0.281|2-Sided|95.0|-0.8|2.8|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-35mg at Week 24|
1719297|NCT00708552|3165792|Superiority||Mean Difference (Net)|1.4||||0.096|2-Sided|95.0|-0.3|3.1|||Mixed model repeated measures|||Baseline MMSE score of 16-26 on ADAS-Cog Total score, Placebo Vs SB-742457-15mg at Week 24|
1720018|NCT00699907|3167264|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test||||
1719299|NCT00708552|3165793|Superiority||Mean Difference (Net)|-2.1||||0.305|2-Sided|95.0|-6.1|1.9|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs SB-742457-35mg at Week 24|
1719300|NCT00708552|3165793|Superiority||Mean Difference (Net)|-1.6||||0.423|2-Sided|95.0|-5.6|2.3|||Mixed model repeated measures|||RBANS Total Score, Placebo Vs SB-742457-15mg at Week 24|
1719301|NCT00708552|3165794|Superiority||Mean Difference (Net)|-0.3||||0.049|2-Sided|95.0|-0.6|0.0|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs Donepezil at Week 24|
1719302|NCT00708552|3165794|Superiority||Mean Difference (Net)|-0.1||||0.394|2-Sided|95.0|-0.4|0.2|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-35mg at Week 24|
1719303|NCT00708552|3165794|Superiority||Mean Difference (Net)|0.2||||0.254|2-Sided|95.0|-0.1|0.5|||Mixed model repeated measures|||CIBIC+ Score, Placebo Vs SB-742457-15mg at Week 24|
1719304|NCT00708552|3165795|Superiority||Mean Difference (Net)|-0.2||||0.821|2-Sided|95.0|-1.6|1.2|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs Donepezil at Week 24|
1719305|NCT00708552|3165795|Superiority||Mean Difference (Net)|0.7||||0.41|2-Sided|95.0|-0.9|2.3|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-35mg at Week 24|
1719306|NCT00708552|3165795|Superiority||Mean Difference (Net)|1.1||||0.159|2-Sided|95.0|-0.4|2.7|||Mixed model repeated measures|||ADAS-Cog Total Score, Placebo Vs SB-742457-15mg at Week 24|
1719307|NCT00708526|3165796|Superiority or Other|||||||0.039|||||||t-test, 2 sided|||The effect of the use of hypercapnia and increased ventilation on the time to recovery events was compared using multivariate analysis of variance with the Hotelling’s two sample T2.-test and the two-tailed unpaired t-test; individual comparisons were by Bonferroni adjusted two tailed unpaired t-tests. The data was tested for normality before identifying statistical significance.|
1719308|NCT00708526|3165797|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|A Bonferroni correction was used.||We compared times for discharge criteria after general anesthesia with and without the QED.|
1719309|NCT00708500|3165800|Superiority or Other||Treatment Difference|45.1|||<|0.0001||95.0|33.4|56.8|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.||
1719310|NCT00708500|3165800|Superiority or Other||Treatment Difference|39.1|||<|0.0001||95.0|27.2|51.0|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.||
1719311|NCT00708500|3165801|Superiority or Other||Treatment Difference|45.2|||<|0.0001||95.0|33.7|56.8|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.||
1719312|NCT00708500|3165801|Superiority or Other||Treatment Difference|37.4|||<|0.0001||95.0|25.7|49.1|||Cochran-Mantel-Haenszel||Difference in percentage of participants who achieved SVR: experimental minus control.||
1719313|NCT00708461|3165802|Superiority or Other (legacy)||Mean Difference (Net)|0.125|Standard Error of the Mean|0.1202||0.36|2-Sided|95.0|-0.21|0.46||Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates. 95% confidence intervals and p-values derived from t-statistics with 4 degrees of freedom, reflecting the group-randomized design.|ANCOVA|Adjusted for age, educational attainment, race/ethnicity, and smoking status as individual, fixed-effect covariates.||"The null hypothesis was no effect of the environmental intervention. The following power assumptions were made:~Intraclass correlation (ICC) of 0.016, estimated from an earlier study~Variance of 118 kg, estimated from an earlier study~Cohort N=400~15% attrition (by turnover) Using the external control and a worksite correlation of 0.2 gives a detectable difference of about 1.5 kg or 3 lb, or an effect size of 0.14. The effect size using internal control is 0.20."|
1719314|NCT00708435|3165812|Non-Inferiority or Equivalence|"The non-inferiority margin was −(minus)10%. If the lower limit of the 2-sided 95% CI was >-10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated ‘effective’ in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."|Difference in the decrease of INR (%)|52.6|||||2-Sided|95.0|39.4|65.9|||||Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI for the difference (Beriplex minus plasma) in the % of subjects with a rapid decrease of the INR.|The analysis of the percentage of participants who had a rapid decrease of the INR was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with a rapid decrease of the INR.|
1719315|NCT00708435|3165813|Non-Inferiority or Equivalence|"The non-inferiority margin was −(minus)10%. If the lower limit of the 2-sided 95% CI was >–10%, then the null-hypothesis was rejected and it was concluded that Beriplex was non-inferior to plasma.~The sample size estimation assumed that hemostatic efficacy would be rated ‘effective’ in 85% of participants in the plasma group and 90% of participants in the Beriplex group. The power to show non-inferiority with these assumptions was greater than 80% for two treatment groups of 83 participants."|Difference in effective hemostasis (%)|7.1|||||2-Sided|95.0|-5.8|19.9|||||Both primary endpoints had to be non-inferior for Beriplex to be non-inferior. There is no P-value as non-inferiority was assessed via the 95% CI calculation for the difference (Beriplex minus plasma) in the % of subjects with effective hemostasis.|The analysis of hemostatic efficacy was via calculation of the 95% confidence interval (CI) for the difference (Beriplex minus plasma) in the percentage of participants with effective hemostasis.|
1719316|NCT00708305|3165816|Superiority or Other||Median Difference (Final Values)|0.03||||0.0012|2-Sided|95.0|0.01|0.04||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719317|NCT00708305|3165816|Superiority or Other||Median Difference (Final Values)|0.05|||<|0.0001|2-Sided|95.0|0.03|0.07|||Wilcoxon Signed Rank Test|No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1720019|NCT00699907|3167264|Superiority or Other||||||>|0.005|||||||Wilcoxon Rank Sum Test||||
1719318|NCT00708305|3165816|Superiority or Other||Median Difference (Final Values)|0.03|||<|0.0107|2-Sided|95.0|0.01|0.06||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719319|NCT00708305|3165816|Superiority or Other||Median Difference (Final Values)|0.04|||<|0.0001|2-Sided|95.0|0.03|0.06||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719320|NCT00708305|3165816|Superiority or Other||Median Difference (Final Values)|0.02|||<|0.0726|2-Sided|95.0|0.0|0.04||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719321|NCT00708305|3165816|Superiority or Other||Median Difference (Final Values)|-0.01|||<|0.4309|2-Sided|95.0|-0.03|0.01||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719322|NCT00708305|3165817|Superiority or Other||Median Difference (Final Values)|0.07|||<|0.0001|2-Sided|95.0|0.04|0.1||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719323|NCT00708305|3165817|Superiority or Other||Median Difference (Final Values)|0.12|||<|0.0001|2-Sided|95.0|0.08|0.2||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719324|NCT00708305|3165817|Superiority or Other||Median Difference (Final Values)|0.08|||<|0.0005|2-Sided|95.0|0.03|0.15||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719325|NCT00708305|3165817|Superiority or Other||Median Difference (Final Values)|0.1|||<|0.0001|2-Sided|95.0|0.07|0.14||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719326|NCT00708305|3165817|Superiority or Other||Median Difference (Final Values)|0.03|||<|0.0531|2-Sided|95.0|0.0|0.07||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719327|NCT00708305|3165817|Superiority or Other||Median Difference (Final Values)|-0.04|||<|0.0783|2-Sided|95.0|-0.08|0.0||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719328|NCT00708305|3165818|Superiority or Other||Median Difference (Final Values)|0.18|||<|0.0001|2-Sided|95.0|0.12|0.25||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719329|NCT00708305|3165818|Superiority or Other||Median Difference (Final Values)|0.34|||<|0.0001|2-Sided|95.0|0.22|0.51||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719330|NCT00708305|3165818|Superiority or Other||Median Difference (Final Values)|0.11|||<|0.0023|2-Sided|95.0|0.04|0.22||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719331|NCT00708305|3165818|Superiority or Other||Median Difference (Final Values)|0.24|||<|0.0001|2-Sided|95.0|0.16|0.38||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719332|NCT00708305|3165818|Superiority or Other||Median Difference (Final Values)|0.04|||<|0.1756|2-Sided|95.0|-0.02|0.12||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719333|NCT00708305|3165818|Superiority or Other||Median Difference (Final Values)|-0.02|||<|0.6865|2-Sided|95.0|-0.13|0.08||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719334|NCT00708305|3165819|Superiority or Other||Median Difference (Final Values)|0.37|||<|0.0001|2-Sided|95.0|0.26|0.56||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719335|NCT00708305|3165819|Superiority or Other||Median Difference (Final Values)|0.91|||<|0.0001|2-Sided|95.0|0.58|1.35||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719336|NCT00708305|3165819|Superiority or Other||Median Difference (Final Values)|0.36|||<|0.0001|2-Sided|95.0|0.15|0.68||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signal Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719337|NCT00708305|3165819|Superiority or Other||Median Difference (Final Values)|0.91|||<|0.0001|2-Sided|95.0|0.58|1.56||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719338|NCT00708305|3165819|Superiority or Other||Median Difference (Final Values)|0.4|||<|0.0003|2-Sided|95.0|0.15|0.71||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719339|NCT00708305|3165819|Superiority or Other||Median Difference (Final Values)|0.08|||<|0.5545|2-Sided|95.0|-0.22|0.47||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719340|NCT00708305|3165820|Superiority or Other||Median Difference (Final Values)|1.01|||<|0.0001|2-Sided|95.0|0.73|1.35||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719341|NCT00708305|3165820|Superiority or Other||Median Difference (Final Values)|2.1|||<|0.0001|2-Sided|95.0|1.5|2.74||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719342|NCT00708305|3165820|Superiority or Other||Median Difference (Final Values)|0.75|||<|0.0001|2-Sided|95.0|0.41|1.27||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719343|NCT00708305|3165820|Superiority or Other||Median Difference (Final Values)|3.01|||<|0.0001|2-Sided|95.0|2.06|4.05||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments. Tests were 2-sided.|
1719344|NCT00708305|3165820|Superiority or Other||Median Difference (Final Values)|1.36|||<|0.0001|2-Sided|95.0|0.69|2.36||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719345|NCT00708305|3165820|Superiority or Other||Median Difference (Final Values)|0.83|||<|0.0151|2-Sided|95.0|0.12|1.72||No adjustments for multiple comparisons were made as the primary comparison was pre-defined.|Wilcoxon Signed Rank Test||Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Statistical tests were 2-sided at 5% significance level.|
1719346|NCT00708305|3165821|Superiority or Other||Adjusted Mean Difference|0.95|||<|0.0001|2-Sided|95.0|0.74|1.16||No adjustment was made for multiple comparisons as the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.|
1719372|NCT00708162|3165866|Superiority or Other||Difference in percentages|-2.9|||||2-Sided|95.0|-10.2|4.4|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.||
1720020|NCT00699907|3167265|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test||||
1719347|NCT00708305|3165821|Superiority or Other||Adjusted Mean Difference|1.44|||<|0.0001|2-Sided|95.0|1.23|1.65||No adjustment was made for multiple comparisons because the comparison was predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.|
1719348|NCT00708305|3165821|Superiority or Other||Adjusted Mean Difference|0.49|||<|0.0001||95.0|0.28|0.7||No adjustment was made for multiple comparisons because the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.|
1719349|NCT00708305|3165821|Superiority or Other||Adjusted Mean Difference|1.44|||<|0.0001||95.0|1.23|1.65||No adjustment was made for multiple comparisons because the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments, being compared. Tests were 2 sided at 5% significance levels.|
1719350|NCT00708305|3165821|Superiority or Other||Adjusted Mean DIfference|0.49|||<|0.0001|2-Sided|95.0|0.28|0.7||No adjustment was made for multiple comparisons as the comparisons were predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments being compared. Tests were 2 sided at 5% significance levels.|
1719351|NCT00708305|3165822|Superiority or Other||Adjusted Mean Difference|0.0||||0.9762||95.0|-0.21|0.2||No adjustment was made for multiple comparisons as the primary comparison was predefined.|ANCOVA|The model included mean baseline fluoride level for treatment period (covariate), treatment and period as fixed and subject was random factor.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis is no difference between treatments in comparison. Tests were 2-sided at 5% significance levels.|
1719352|NCT00708227|3165826|Superiority|||||||0.06|||||||ANOVA||||
1719353|NCT00708227|3165827|Superiority|||||||0.15|||||||ANOVA||||
1719354|NCT00708227|3165828|Superiority|||||||0.27|||||||ANOVA||||
1719355|NCT00708201|3165846|Superiority or Other||Percent difference|-6.94||||0.0946|2-Sided|95.0|-14.5|0.62|||Fisher Exact||Percent difference = alvimopan − placebo.||
1719356|NCT00708201|3165847|Superiority or Other||Percent difference|25.2|||<|0.0001|2-Sided||||||Fisher Exact||Percent difference = alvimopan − placebo|Statistical analysis for day of surgery (Day 0) through PSD 7 is presented.|
1719357|NCT00708201|3165848|Superiority or Other||Percent difference|27.05|||<|0.0001|2-Sided||||||Fisher Exact||Percent difference = alvimopan − placebo|Statistical analysis for day of surgery (Day 0) through PSD 7 is presented.|
1719358|NCT00708201|3165849|Superiority or Other||Percent difference|-20.71|||<|0.001|2-Sided||||||Fisher Exact||Percent difference = alvimopan − placebo|Statistical analysis for overall POM is presented.|
1719359|NCT00708201|3165850|Superiority or Other||Relative Risk|1.38|||<|0.01|2-Sided|95.0|1.12|1.71|||Fisher Exact||This is the relative risk for being a responder (alvimopan/placebo).||
1719360|NCT00708201|3165851|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1719361|NCT00708201|3165852|Superiority or Other||Mean Difference (Final Values)|-22.4|||<|0.001|2-Sided|95.0|-35.0|-9.9|||Log Rank||||
1719362|NCT00708201|3165853|Superiority or Other||Mean Difference (Final Values)|-24.7|||<|0.001|2-Sided|95.0|-37.8|-11.5|||Log Rank||||
1719363|NCT00708201|3165854|Superiority or Other||Hazard Ratio (HR)|1.773|||<|0.0001|2-Sided|95.0|1.359|2.311|||Wald’s Chi-Square||||
1719364|NCT00708175|3165858|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.64|2-Sided|95.0|-0.91|0.56||P-value is from a 1-way ANCOVA with treatment group as a factor and the Month 12 BMD value as a covariate. There were no multiplicity adjustments.|ANCOVA||||
1719365|NCT00708175|3165859|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.17|2-Sided|95.0|-1.33|0.24||P-value is from a 1-way ANCOVA with treatment group as a factor and baseline BMD as a covariate. There were no multiplicity adjustments.|ANCOVA|||The sample size was calculated using a precision approach to estimate the difference between the pioglitazone and placebo treatment groups in the percent change from baseline in BMD.|
1719366|NCT00708162|3165860|Superiority or Other||Difference in cells/mm^3|7.0|||||2-Sided|95.0|-25.0|39.0|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).||
1719367|NCT00708162|3165861|Superiority or Other||Difference in cells/mm^3|-9.0|||||2-Sided|95.0|-33.0|16.0|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).||
1719368|NCT00708162|3165862|Superiority or Other||Difference in log10 copies/mL|0.05|||||2-Sided|95.0|-0.12|0.22|||||The difference in LSM and its 95% CI were obtained using ANOVA adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).||
1719369|NCT00708162|3165863|Superiority or Other||Difference in log10 copies/mL|0.01|||||2-Sided|95.0|-0.16|0.19|||||The difference in least squares means (LSM) and its 95% CI were obtained using an analysis of variance model (ANOVA) adjusting for baseline HIV-1 RNA level and class of the second agent (NRTI or other classes).||
1719370|NCT00708162|3165864|Superiority or Other||Difference in percentages|-1.7|||||2-Sided|95.0|-8.8|5.5|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.||
1719371|NCT00708162|3165865|Superiority or Other||Difference in percentages|-2.0|||||2-Sided|95.0|-8.6|4.7|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.||
1719373|NCT00708162|3165867|Superiority or Other||Difference in percentages|0.2|||||2-Sided|95.0|-6.9|7.3|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.||
1719374|NCT00708162|3165872|Superiority or Other||Difference in percentages|-0.5|||||2-Sided|95.0|-7.9|6.8|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.||
1719375|NCT00708162|3165873|Superiority or Other||Difference in percentages|2.2|||||2-Sided|95.0|-5.0|9.3|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.||
1719376|NCT00708162|3165874|Superiority or Other||Difference in percentages|0.9|||||2-Sided|95.0|-6.4|8.2|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.||
1719377|NCT00708162|3165875|Superiority or Other||Difference in percentages|0.9|||||2-Sided|95.0|-6.0|7.7|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.||
1719378|NCT00708162|3165876|Non-Inferiority or Equivalence|Null hypothesis: the EVG arm was at least 10% worse than the RAL arm with respect to percentage of participants achieving and maintaining HIV-1 RNA < 50 copies/mL through Week 48; alternative hypothesis: the EVG arm was less than 10% worse than the RAL arm.|Difference in percentages|2.6|||||2-Sided|95.0|-4.6|9.9|||||The difference in percentages and its 95% CI were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using MH proportions and normal approximation.||
1719379|NCT00708162|3165877|Non-Inferiority or Equivalence|Null hypothesis: the EVG group was at least 10% worse than the RAL group with respect to percentage of participants achieving and maintaining HIV-1 RNA < 50 copies/mL through Week 48; alternative hypothesis: the EVG group was less than 10% worse than the RAL group.|Difference in percentages|1.1|||||2-Sided|95.0|-6.0|8.2|||||The difference in percentages and its 95% confidence interval (CI) were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using Mantel-Haenszel (MH) proportions and normal approximation.|The planned sample size of 700 HIV-1 infected participants, (350 in each group) was estimated to provide at least 85% power to establish noninferiority in the percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL through Week 48. For sample size and power computation, it was assumed that both elvitegravir and raltegravir arms have a response rate of 0.74, that a noninferiority margin was 0.10, and that the significance level of the test was 1-sided 0.025 level.|
1719380|NCT00708123|3165878|Superiority or Other||Adjusted Mean Difference|244.62||||0.0024|2-Sided|95.0|87.62|401.61||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719381|NCT00708123|3165878|Superiority or Other||Adjusted Mean Difference|650.8|||<|0.0001|2-Sided|95.0|493.61|808.0||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719382|NCT00708123|3165878|Superiority or Other||Adjusted Mean Difference|897.5|||<|0.0001|2-Sided|95.0|739.92|1055.08||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors treatment, period and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719383|NCT00708123|3165878|Superiority or Other||Adjusted Mean Difference|847.55|||<|0.0001|2-Sided|95.0|690.54|1004.55||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719384|NCT00708123|3165878|Superiority or Other||Adjusted Mean Difference|652.89|||<|0.0001|2-Sided|95.0|495.05|810.72||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719385|NCT00708123|3165878|Superiority or Other||Adjusted Mean Difference|602.93|||<|0.0001|2-Sided|95.0|445.97|759.9||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719386|NCT00708123|3165878|Superiority or Other||Mean Difference (Final Values)|-406.19|||<|0.0001|2-Sided|95.0|-564.0|-248.37||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719387|NCT00708123|3165878|Superiority or Other||Adjusted Mean Difference|-49.96|||<|0.5328|2-Sided|95.0|-207.62|107.71||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719388|NCT00708123|3165878|Superiority or Other||Adjusted Mean Difference|246.7|||<|0.0024|2-Sided|95.0|88.3|405.1||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719389|NCT00708123|3165878|Superiority or Other||Adjusted Mean Difference|196.74|||<|0.0148|2-Sided|95.0|38.89|354.6||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments. Tests were 2-sided at 5% significance level.|
1719390|NCT00708123|3165879|Superiority or Other||Adjusted Mean DIfference|2.93||||0.0986|2-Sided|95.0|-0.55|6.41||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719391|NCT00708123|3165879|Superiority or Other||Adjusted Mean Difference|7.52|||<|0.0001|2-Sided|95.0|4.04|11.01||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719392|NCT00708123|3165879|Superiority or Other||Adjusted Mean Difference|-4.59|||<|0.0104|2-Sided|95.0|-8.1|-1.09||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719393|NCT00708123|3165879|Superiority or Other||Adjusted Mean Difference|11.5|||<|0.0001|2-Sided|95.0|8.01|14.98||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject (random effect).|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719394|NCT00708123|3165879|Superiority or Other||Adjusted Mean Difference|8.57|||<|0.0001|2-Sided|95.0|5.09|12.05||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719395|NCT00708123|3165879|Superiority or Other||Adjusted Mean Difference|13.19|||<|0.0001|2-Sided|95.0|9.69|16.68||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719396|NCT00708123|3165879|Superiority or Other||Adjusted Mean Difference|10.26|||<|0.0001|2-Sided|95.0|6.76|13.76||No adjustments made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719397|NCT00708123|3165879|Superiority or Other||Adjusted Mean DIfference|-1.69|||<|0.3413|2-Sided|95.0|-5.19|1.8||No adjustment was made for multiple comparisons as the primary comparisons were pre-defined.|ANOVA|ANOVA with factors for treatment, study period, and subject as random effect|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719398|NCT00708123|3165880|Superiority or Other||Adjusted mean difference|5.66||||0.0017|2-Sided|95.0|2.15|9.18||No adjustment was made for multiple comparisons as primary comparisons were pre-defined.|ANOVA|The analysis included factors as treatment, period and subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719399|NCT00708123|3165880|Superiority or Other||Adjusted mean difference|3.97||||0.0265|2-Sided|95.0|0.47|7.48||No adjustment was made for multiple comparisons as primary comparisons were pre-defined.|ANOVA|The analysis included factors treatment, period and subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis was no difference between treatments being compared. Tests were 2-sided at 5% significance level.|
1719400|NCT00708110|3165905|Superiority or Other||Mean Difference (Final Values)|-2.48|||<|0.001|2-Sided|95.0|-2.94|-2.02|||ANCOVA||||
1719401|NCT00708110|3165905|Superiority or Other||Mean Difference (Final Values)|-2.04|||<|0.001|2-Sided|95.0|-2.52|-1.55|||ANCOVA||||
1719402|NCT00708110|3165905|Superiority or Other||Mean Difference (Final Values)|-1.54|||<|0.001|2-Sided|95.0|-2.0|-1.07|||ANCOVA||||
1719403|NCT00708097|3165906|Superiority or Other||Adjusted Mean Difference|1175.62|||<|0.0001|2-Sided|95.0|869.15|1482.1||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719404|NCT00708097|3165906|Superiority or Other||Adjusted Mean Difference|1237.58|||<|0.0001|2-Sided|95.0|931.46|1543.7|||ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719405|NCT00708097|3165906|Superiority or Other||Adjusted Mean Difference|61.96|||<|0.6874|2-Sided|95.0|-241.25|365.17||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719406|NCT00708097|3165906|Superiority or Other||Adjusted Mean Difference|1827.19|||<|0.0001|2-Sided|95.0|1519.78|2134.6||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719407|NCT00708097|3165906|Superiority or Other||Adjusted Mean Difference|651.57|||<|0.0001|2-Sided|95.0|346.44|956.7||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719408|NCT00708097|3165906|Superiority or Other||Adjusted Mean Difference|589.61|||<|0.0002|2-Sided|95.0|285.31|893.92|||ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719409|NCT00708097|3165906|Superiority or Other||Adjusted Mean Difference|1813.29|||<|0.0001|2-Sided|95.0|1503.03|2123.54||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719410|NCT00708097|3165906|Superiority or Other||Adjusted Mean Difference|637.67|||<|0.0001|2-Sided|95.0|330.3|945.03||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719411|NCT00708097|3165906|Superiority or Other||Adjusted Mean Difference|575.71|||<|0.0003|2-Sided|95.0|268.24|883.17||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719412|NCT00708097|3165906|Superiority or Other||Adjusted Mean Difference|-13.9|||<|0.9293|2-Sided|95.0|-322.47|294.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719413|NCT00708097|3165907|Superiority or Other||Adjusted Mean Difference|115.58||||0.0289|2-Sided|95.0|12.02|219.13||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719414|NCT00708097|3165907|Superiority or Other||Adjusted Mean Difference|61.55||||0.2432|2-Sided|95.0|-42.14|165.24||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719415|NCT00708097|3165907|Superiority or Other||Adjusted Mean Difference|54.03||||0.3003|2-Sided|95.0|-48.56|156.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719475|NCT00707746|3166025|Superiority or Other|||||||0.005||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided||||
1719476|NCT00707746|3166027|Superiority or Other||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided||||
1719416|NCT00708097|3165907|Superiority or Other||Adjusted Mean Difference|224.48|||<|0.0001|2-Sided|95.0|120.51|328.46||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719417|NCT00708097|3165907|Superiority or Other||Adjusted Mean Difference|162.93|||<|0.0021|2-Sided|95.0|59.68|266.18||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719418|NCT00708097|3165907|Superiority or Other||Adjusted Mean Difference|108.91|||<|0.0382|2-Sided|95.0|5.98|211.83||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719419|NCT00708097|3165907|Superiority or Other||Adjusted Mean Difference|222.47|||<|0.0001|2-Sided|95.0|117.58|327.36||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719420|NCT00708097|3165907|Superiority or Other||Adjusted Mean Difference|160.92|||<|0.0026|2-Sided|95.0|56.96|264.88||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719421|NCT00708097|3165907|Superiority or Other||Adjusted Mean Difference|106.9|||<|0.044|2-Sided|95.0|2.92|210.87||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719422|NCT00708097|3165907|Superiority or Other||Adjusted Mean Difference|-2.01|||<|0.9697|2-Sided|95.0|-106.34|102.32||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a positive difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to EFU. Statistical tests were 2-sided with a significance level of 0.05.|
1719423|NCT00708097|3165908|Superiority or Other||Adjusted Mean Difference|16.05|||<|0.0001|2-Sided|95.0|11.36|20.74||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719424|NCT00708097|3165908|Superiority or Other||Adjusted Mean Difference|20.03|||<|0.0001|2-Sided|95.0|15.35|24.7||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719425|NCT00708097|3165908|Superiority or Other||Adjusted Mean Difference|3.98|||<|0.0925|2-Sided|95.0|-0.66|8.61||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719426|NCT00708097|3165908|Superiority or Other||Adjusted Mean Difference|24.97|||<|0.0001|2-Sided|95.0|20.27|29.66||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719427|NCT00708097|3165908|Superiority or Other||Adjusted Mean Difference|8.92|||<|0.0002|2-Sided|95.0|4.24|13.59||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719477|NCT00707746|3166029|Superiority or Other||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided||||
1719428|NCT00708097|3165908|Superiority or Other||Adjusted Mean Difference|4.94|||<|0.0373|2-Sided|95.0|0.29|9.59||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719429|NCT00708097|3165908|Superiority or Other||Adjusted Mean Difference|23.52|||<|0.0001|2-Sided|95.0|18.79|28.25||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719430|NCT00708097|3165908|Superiority or Other||Adjusted Mean Difference|7.47|||<|0.002|2-Sided|95.0|2.78|12.16||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719431|NCT00708097|3165908|Superiority or Other||Adjusted Mean Difference|3.5|||<|0.1433|2-Sided|95.0|-1.2|8.19||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719432|NCT00708097|3165908|Superiority or Other||Adjusted Mean Difference|-1.45|||<|0.5451|2-Sided|95.0|-6.15|3.26||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719433|NCT00708097|3165909|Superiority or Other||Adjusted Mean Difference|-27.87|||<|0.0001|2-Sided|95.0|-34.84|-20.89||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719434|NCT00708097|3165909|Superiority or Other||Adjusted Mean Difference|-27.25|||<|0.0001|2-Sided|95.0|-34.2|-20.3||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719435|NCT00708097|3165909|Superiority or Other||Adjusted Mean Difference|0.62|||<|0.8599|2-Sided|95.0|-6.28|7.51||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719436|NCT00708097|3165909|Superiority or Other||Adjusted Mean Difference|-27.06|||<|0.0001|2-Sided|95.0|-34.03|-20.08||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719437|NCT00708097|3165909|Superiority or Other||Adjusted Mean Difference|0.81|||<|0.8188|2-Sided|95.0|-6.14|7.76||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719438|NCT00708097|3165909|Superiority or Other||Adjusted Mean Difference|0.19|||<|0.9567|2-Sided|95.0|-6.71|7.09||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719439|NCT00708097|3165909|Superiority or Other||Adjusted Mean Difference|-25.07|||<|0.0001|2-Sided|95.0|-32.09|-18.06||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719586|NCT00706641|3166185|Superiority or Other|||||||0.2|||||||paired t-test||||
1720021|NCT00699907|3167265|Superiority or Other||||||>|0.01|||||||Wilcoxon Rank Sum Test||||
1719440|NCT00708097|3165909|Superiority or Other||Adjusted Mean Difference|2.79|||<|0.4306|2-Sided|95.0|-4.18|9.77||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719441|NCT00708097|3165909|Superiority or Other||Adjusted Mean Difference|2.17|||<|0.5387|2-Sided|95.0|-4.79|9.14||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719442|NCT00708097|3165910|Superiority or Other||Adjusted Mean Difference|1.98||||0.5757|2-Sided|95.0|-5.0|8.97||No adjustment made for multiple comparisons as the primary comparison was pre-specified.|ANOVA|ANOVA with factors for treatment and period with subject as a random effect.|Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.|Null hypothesis considered population means of the treatments in comparison, to be equal with respect to percent SMH. Statistical tests were 2-sided with a significance level of 0.05.|
1719443|NCT00708071|3165916|Superiority or Other||Difference in proportions|0.182||||0.014|2-Sided|95.0|0.04|0.34|||McNemar's test of paired proportions|Alpha = 5%|Difference in Proportions = (Number of SoC Participants with Hematoma/Seroma) - (Number of FS VH S/D 4 Participants with Hematoma/Seroma)||
1719444|NCT00708071|3165918|Superiority or Other|||||||0.001|||||||two-sided paired t-test|alpha = 5%|||
1719445|NCT00708071|3165921|Superiority or Other|||||||0.699|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719446|NCT00708071|3165922|Superiority or Other|||||||1|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719447|NCT00708071|3165923|Superiority or Other|||||||0.661|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719448|NCT00708071|3165924|Superiority or Other|||||||0.324||||||alpha = 10%|Two-sided Wilcoxon paired sample tests||||
1719449|NCT00708071|3165925|Superiority or Other|||||||0.521|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719450|NCT00708071|3165926|Superiority or Other|||||||1|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719451|NCT00708071|3165927|Superiority or Other|||||||0.688|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719452|NCT00708071|3165928|Superiority or Other|||||||0.625|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719453|NCT00708071|3165929|Superiority or Other|||||||0.688||||||Two-sided Wilcoxon paired sample tests|Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719454|NCT00708071|3165930|Superiority or Other|||||||0.234|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719455|NCT00708071|3165931|Superiority or Other|||||||0.388|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719456|NCT00708071|3165932|Superiority or Other|||||||0.754|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719457|NCT00708071|3165934|Superiority or Other|||||||0.715|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719458|NCT00708071|3165935|Superiority or Other|||||||0.247|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719459|NCT00708071|3165936|Superiority or Other|||||||0.501|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719460|NCT00708071|3165937|Superiority or Other|||||||0.833|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719461|NCT00708071|3165938|Superiority or Other|||||||0.103|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719462|NCT00708071|3165939|Superiority or Other|||||||0.645|||||||Two-sided Wilcoxon paired sample tests|alpha = 10%|||
1719463|NCT00708071|3165940|Superiority or Other||Difference in proportions|0.038|||||2-Sided|90.0|-0.17|0.24|||||Difference in proportions = SoC – FS VH S/D 4||
1719464|NCT00708071|3165941|Superiority or Other||Difference in proportions|0.0|||||2-Sided|90.0|-0.21|0.21|||||Difference in proportions = SoC – FS VH S/D 4||
1719465|NCT00708071|3165942|Superiority or Other||Difference in proportions|-0.032|||||2-Sided|90.0|-0.24|0.18|||||Difference in proportions = SoC – FS VH S/D 4||
1719466|NCT00708071|3165943|Superiority or Other||Difference in proportions|0.111|||||2-Sided|90.0|-0.11|0.32|||||Difference in proportions = SoC – FS VH S/D 4||
1719467|NCT00708071|3165944|Superiority or Other||Difference in proportions|0.31|||||2-Sided|90.0|0.12|0.48|||||Difference in proportions = SoC – FS VH S/D 4||
1719468|NCT00708071|3165945|Superiority or Other||Difference in Proportions|0.25||||0.143||95.0|-0.04|0.49|||McNemar||Difference in Proportions = SoC - FS VH S/D 4||
1719469|NCT00707993|3165971|Superiority or Other||Mean Difference (Final Values)|-0.05|||||1-Sided|97.5||0.13||||||Primary null hypothesis: the average Week 52 HbA1c change from Baseline for alogliptin is inferior to that for glipizide (1-sided 97.5% CI [alpha=0.025] compared to non-inferiority margin of 0.4%). If the primary null hypothesis was rejected (non-inferiority demonstrated), an additional comparison for statistical superiority of alogliptin was performed. The CI was re-evaluated; statistical superiority declared if the upper limit was < 0%.|
1719470|NCT00707746|3166015|Superiority or Other|||||||0.079||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided||||
1719471|NCT00707746|3166017|Superiority or Other|||||||0.784||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided||||
1719472|NCT00707746|3166019|Superiority or Other||||||<|0.001||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided||||
1719473|NCT00707746|3166021|Superiority or Other|||||||0.006||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided||||
1719474|NCT00707746|3166023|Superiority or Other||||||<|0.001||||||Statistical significance was concluded if p ≤0.05. No further adjustments were made for tertiary parameters.|t-test, 2 sided||||
1719478|NCT00707746|3166031|Superiority or Other||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|Wilcoxon signed rank sum||||
1719479|NCT00707746|3166034|Superiority or Other||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|t-test, 2 sided|||It was estimated that the standard deviation of the percent change in LDL-C was 20%. A sample size of 30 patients was planned for this study: 20 patients in the mipomersen group and 10 patients in the placebo group. A 2-sided t-test with an alpha level of 0.05 was expected to provide ≥90% power to detect a 30% difference in LDL-C percent reduction between the 2 groups (35% reduction for the mipomersen group and 5% reduction for the placebo group).|
1719480|NCT00707577|3166038|Superiority||||||<|0.05|||||||Regression, Linear|random effects regression models for panel data adjusted for clustering within team|||
1719481|NCT00707447|3166041|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1719482|NCT00707447|3166042|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1719483|NCT00707447|3166043|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1719484|NCT00707447|3166044|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1719485|NCT00707447|3166045|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1719486|NCT00707447|3166046|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1719487|NCT00707447|3166047|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1719488|NCT00707447|3166048|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1719489|NCT00707447|3166049|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||independent t-tests for between group comparisons, dependent t-tests for within group comparisons|
1719490|NCT00707447|3166050|Superiority or Other||||||<|0.05||||||There was only one primary outcome variable, thus no adjustments for multiple comparisons were made.|t-test, 2 sided|||independent t-tests for between group comparisons, dependent t-tests for within group comparisons|
1719491|NCT00707239|3166053|Superiority or Other|||||||0.192||||||Statistical testing was done at 5% alpha.|ANOVA|||ICU stay: One−way ANOVA with treatment as factor was used to calculate p-value.|
1719492|NCT00707239|3166053|Superiority or Other|||||||0.484||||||Statistical testing was done at 5% alpha.|ANOVA|||Hospital stay: One−way ANOVA with treatment as factor was used to calculate p-value.|
1719493|NCT00707239|3166053|Superiority or Other|||||||0.245||||||Statistical testing was done at 5% alpha.|ANOVA|||Intravenous antibiotic treatment: One−way analysis of variance (ANOVA) with treatment as factor was used to calculate p-value.|
1719494|NCT00707239|3166057|Superiority or Other||Odds Ratio (OR)|1.0054||||0.836|2-Sided|95.0|0.956|1.06|||Regression, Logistic|||Statistical analysis was carried out between categories, cure and failure/indeterminate.|
1719495|NCT00707239|3166058|Superiority or Other||Odds Ratio (OR)|0.84644||||0.356|2-Sided|95.0|0.593|1.21|||Regression, Logistic|||Statistical analysis was carried out between categories, experienced vomiting and did not experience vomiting.|
1719496|NCT00707239|3166058|Superiority or Other||Odds Ratio (OR)|1.0479||||0.78|2-Sided|95.0|0.754|1.46|||Regression, Logistic|||Statistical analysis was carried out between categories, experienced nausea and did not experience nausea.|
1719497|NCT00707239|3166064|Superiority or Other|||||||1||||||Statistical testing was done at 5% alpha.|Fisher Exact|||p-value was calculated using 2-tail Fischer's exact test.|
1719498|NCT00707239|3166065|Superiority or Other|||||||1||||||Statistical testing was done at 5% alpha.|Fisher Exact|||p-value was calculated using 2-tail Fischer's exact test.|
1719499|NCT00707239|3166066|Superiority or Other|||||||0.39||||||Statistical testing was done at 5% alpha.|Fisher Exact|||Vomiting: p-value was calculated using 2-tail Fischer's exact test.|
1719500|NCT00707239|3166066|Superiority or Other|||||||0.527||||||Statistical testing was done at 5% alpha.|Fisher Exact|||Nausea: p-value was calculated using 2-tail Fischer's exact test.|
1719501|NCT00707239|3166067|Superiority or Other||Risk Difference (RD)|0.0|||||2-Sided|70.0|-23.8|20.9||||||Eradication: CI was calculated using the Wilson score method, with continuity correction. Microbiological response (rates of eradication) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.|
1719502|NCT00707239|3166067|Superiority or Other||Risk Difference (RD)|-18.5|||||2-Sided|70.0|-39.6|4.2||||||Eradication: CI was calculated using the Wilson score method, with continuity correction. Microbiological response (rates of eradication) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.|
1719503|NCT00707239|3166070|Superiority or Other||Risk Difference (RD)|18.5|||||2-Sided|70.0|4.3|31.8||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.|
1719504|NCT00707239|3166070|Superiority or Other||Risk Difference (RD)|-0.2|||||2-Sided|70.0|-14.3|14.0||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.|
1719505|NCT00707239|3166071|Superiority or Other||Risk Difference (RD)|10.0|||||2-Sided|70.0|-6.1|24.8||||||Cure: CI was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70% CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.|
1719506|NCT00707239|3166071|Superiority or Other||Risk Difference (RD)|-5.4|||||2-Sided|70.0|-21.6|10.9||||||Cure: Confidence interval (CI) was calculated using the Wilson score method, with continuity correction. Clinical response (rates of cure) by using a 2-sided 70 percent (%) CI for the true difference in efficacy (tigecycline regimen minus imipenem/cilastatin regimen) was calculated. Statistical testing was done at 15% alpha.|
1719587|NCT00706641|3166188|Superiority or Other|||||||0.003|||||||paired t-test|||Tumor samples from 20 patients were analyzed for expression of pSFK. A paired t-Test was used to calculate the significance of the difference in expression levels before and after treatment.|
1719507|NCT00707057|3166074|Superiority or Other||||||<|0.0001||||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Overall relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.|
1719508|NCT00707057|3166074|Superiority or Other||||||<|0.0001||||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Maximum relief scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 4 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.|
1719509|NCT00707057|3166074|Superiority or Other||||||<|0.0001||||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation scores for dose 4 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 4 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.|
1719510|NCT00707057|3166075|Superiority or Other||||||<|0.0001||||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Overall relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide overall relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.|
1719511|NCT00707057|3166075|Superiority or Other||||||<|0.0001||||||P-value from ANCOVA with terms for treatment, gender and basee pain score categories.|ANCOVA|||Maximum relief scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide maximum relief of dose 3 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief.|
1719512|NCT00707057|3166075|Superiority or Other||||||<|0.0001||||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation scores for dose 3 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics. The subjects were to provide global evaluation of dose 3 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief.|
1719513|NCT00707057|3166076|Superiority or Other||||||<|0.0001||||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||"Overall relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide overall relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief."|
1719514|NCT00707057|3166076|Superiority or Other||||||<|0.0001||||||P-value from ANCOVA with terms for treatment, gender and baseline pain scores categories.|ANCOVA|||"Maximum relief scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide maximum relief scores for dose 2 study medication on an 11-point pain intensity numerical rating scale (PI-NRS)in response to pain relief."|
1719515|NCT00707057|3166076|Superiority or Other||||||<|0.0001||||||P- value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||"Global evaluation scores for dose 2 were summarized by descriptive statistics. Only non-missing values are used for the summary statistics.~The subjects were to provide global evaluation of dose 2 study medication using a range that went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)in response to pain relief."|
1719516|NCT00707057|3166077|Superiority or Other||||||<|0.0001||||||P-value from ANCOVA with terms for treatment, gender and baseline pain score categories.|ANCOVA|||Global evaluation for dose 1, either at the time of rescue or at dose 2 whichever came first were summarized by descriptive statistics based on non-missing data. The range went from 0 (Very poor) to 10 (Excellent) units on an 11-point Pain Intensity Numerical Rating Scale (PI-NRS).|
1719517|NCT00707057|3166078|Superiority or Other||||||<|0.0001|||||||ANCOVA|||The pain relief and PID scores at individual time points were summarized by descriptive statistics. The test and reference were compared at each individual time point at 24, 36 and 48 hours.|
1719518|NCT00707057|3166079|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||The proportions of subjects who rescued at or prior to hour 8, hour 10, and hour 12 were reported and 95% confidence intervals for the corresponding parameters were calculated.|
1719519|NCT00707057|3166080|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1719520|NCT00707057|3166081|Superiority or Other||||||<|0.0001|||||||ANCOVA|With terms for treatment, gender, and baseline pain score categories stratified as ≤7 and >7.||The PID at each time point prior to dose 2 was derived by substracting the pain intensity from the base line pain intensity, so that a higher value was indicative of a greater improvement. Time weighted SPID for each specified interval was derived by first multiplying each PID score by the time from the previous time point, and adding them together for each scheduled time point within the time interval. Time weighted TOTPAR for ech specified interval was similarly derived.|
1719521|NCT00707057|3166082|Superiority or Other||||||<|0.0001||||||Estimated Confidence Interval: 95%Method: Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel||||
1719522|NCT00707057|3166082|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1719523|NCT00707057|3166083|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1719524|NCT00707057|3166084|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.|
1719525|NCT00707057|3166085|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Time to confirmed first perceptible relief was defined as the time to first perceptible relief, provided that the subject also stopped the second stopwatch indicating meaningful relief. For those who failed to achieve confirmed first perceptible and/or meaningful relief, a censored time was assigned.|
1719588|NCT00706628|3166202|Superiority or Other||Slope|1.4823|Standard Error of the Mean|0.149|||2-Sided|95.0|1.1754|1.7892|||||||
1719526|NCT00707057|3166086|Superiority or Other||||||<|0.0017|||||||ANCOVA|||The null versus alternative hypothesis regarding the durability of analgesic efficacy using the PID scores at 24, 36, and 48 hours.An individual subject was to achieve the 2-point reduction at all 3 terminal time points in order to be defined as responder.|
1719527|NCT00707057|3166087|Superiority or Other||||||<|0.0001|||||||ANCOVA|||The null versus alternative hypothesis regarding the analgesic efficacy using the SPID 8-12 was compared between the 2 treatment groups using an analysis of covariance (ANCOVA)model with each subject's outcome being his/her SPID 8-12 as the dependent variable in the ANCOVA model with terms for gender, treatment, and baseline pain score categories (stratified as ≤7 and >7).|
1719528|NCT00707031|3166096|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the upper limit of the 2-sided 95% confidence interval of the difference between lixisenatide and exenatide on mITT population was <=0.4%.|Least squares (LS) mean difference|0.17|Standard Error of the Mean|0.067|||2-Sided|95.0|0.033|0.297||||||To detect that upper confidence limit of 2-sided 95% confidence interval for least square (LS) mean difference between the 2 arms do not exceed 0.4% HbA1c, 300 patients per group would provide 96% power assuming a standard deviation of 1.3 and true difference in HbA1c between the 2 arms as 0.|
1719529|NCT00706979|3166099|Superiority or Other||Risk Ratio (RR)|1.2||||0.3|2-Sided|95.0|0.9|1.6|||Regression, Logistic|||A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate for 7 days of abstinence at the six month follow-up.|
1719530|NCT00706979|3166100|Superiority or Other||Risk Ratio (RR)|1.3||||0.004|2-Sided|95.0|1.1|1.5|||Regression, Logistic|||A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate for the primary outcome of any 24hr quit attempt.|
1719531|NCT00706979|3166101|Superiority or Other||Risk Ratio (RR)|1.3||||0.09|2-Sided|95.0|1.0|1.7|||Regression, Logistic|||A logistic regression model was used to examine the secondary hypothesis that NRT-enhanced PQAs would yield a higher rate of 7 days of abstinence at some point during the study.|
1719532|NCT00706979|3166102|Superiority or Other||Risk Ratio (RR)|1.2||||0.008|2-Sided|95.0|1.1|1.4|||Regression, Logistic|||A logistic regression model was used to examine the primary hypothesis that NRT-enhanced PQAs would yield a higher rate of any ever-occurring quit attempt.|
1719533|NCT00706901|3166117|Non-Inferiority or Equivalence|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.67|||||||Zero-hurdle Poisson model||||
1719534|NCT00706901|3166117|Non-Inferiority or Equivalence|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.||||||0.17|||||||Zero inflated Poisson model||||
1719535|NCT00706901|3166118|Non-Inferiority or Equivalence|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.02|||||||Zero-hurdle Poisson model||||
1719536|NCT00706901|3166118|Non-Inferiority or Equivalence|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.|||||<|0.0001|||||||Zero inflated Poisson model||||
1719537|NCT00706901|3166119|Non-Inferiority or Equivalence|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.0001|||||||Zero-hurdle Poisson model||||
1719538|NCT00706901|3166119|Non-Inferiority or Equivalence|Zero inflated Poisson model with random intercept to account for correlation between repeated measurement of the responses within subjects was conducted.|||||<|0.01|||||||Zero inflated Poisson model||||
1719539|NCT00706901|3166120|Non-Inferiority or Equivalence|A generalized linear mixed model with correlated errors to account for correlation between repeated measurements of the response within subjects was conducted.||||||0.47|||||||Mixed Models Analysis||||
1719540|NCT00706901|3166120|Non-Inferiority or Equivalence|To examine differences between GMI and TCC on SECs, a two-component Weibull mixture model for effectively dealing with zero-heavy continuous data was conducted.||||||0.04|||||||Weibull mixture model||||
1719541|NCT00706901|3166121|Non-Inferiority or Equivalence|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.0002|||||||Zero-hurdle Poisson model||||
1719542|NCT00706901|3166121|Non-Inferiority or Equivalence|A Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.01|||||||Zero inflated Poisson model||||
1719543|NCT00706901|3166122|Non-Inferiority or Equivalence|Zero-hurdle Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.||||||0.02|||||||zero-hurdle Poisson model||||
1719544|NCT00706901|3166122|Non-Inferiority or Equivalence|Zero-inflated Poisson model with random intercept to account for correlation between repeated measurements of the responses within subjects was conducted.|||||<|0.01|||||||Zero inflated Poisson model||||
1719545|NCT00706849|3166124|Superiority or Other|||||||0.207||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)||||
1719546|NCT00706849|3166126|Superiority or Other|||||||0.004||||||No adjustments were made for tertiary parameters.|t-test, 2 sided||||
1719547|NCT00706849|3166128|Superiority or Other||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)||||
1719548|NCT00706849|3166130|Superiority or Other|||||||0.023||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)||||
1719549|NCT00706849|3166132|Superiority or Other||||||<|0.001||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)||||
1719550|NCT00706849|3166134|Superiority or Other|||||||0.042||||||No adjustments were made for tertiary parameters.|Wilcoxon (Mann-Whitney)||||
1719551|NCT00706849|3166136|Superiority or Other||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided||||
1719589|NCT00706628|3166204|Superiority or Other|||||||0.0863|||||||Fisher Exact||||
1719590|NCT00706628|3166204|Superiority or Other|||||||0.0577|||||||Fisher Exact||||
1719552|NCT00706849|3166138|Superiority or Other||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided||||
1719553|NCT00706849|3166140|Superiority or Other||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided||||
1719554|NCT00706849|3166142|Superiority or Other||||||<|0.001||||||Statistical significance was concluded if p ≤ 0.05.|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With 20 patients in the control group and 40 patients in the mipomersen-treated group, this study would have at least 90% power to detect a 20% difference between the 2 treatment groups.|
1719555|NCT00706823|3166144|Superiority or Other||Odds Ratio (OR)|8.11||||0.03|2-Sided|95.0|1.1|58.6|||Regression, Logistic||||
1719556|NCT00706823|3166146|Superiority or Other|||||||0.22|||||||t-test, 2 sided||||
1719557|NCT00706823|3166148|Superiority or Other|||||||0.22|||||||Fisher Exact||||
1719558|NCT00706823|3166149|Superiority or Other|||||||0.02|||||||t-test, 2 sided||||
1719559|NCT00706719|3166171|Superiority or Other|||||||0.109|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).|
1719560|NCT00706719|3166171|Superiority or Other|||||||0.003|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.|
1719561|NCT00706719|3166171|Superiority or Other|||||||0.015|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.|
1719562|NCT00706719|3166171|Superiority or Other|||||||0.008|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.|
1719563|NCT00706719|3166172|Superiority or Other|||||||0.808|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).|
1719564|NCT00706719|3166172|Superiority or Other|||||||0.004|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.|
1719565|NCT00706719|3166172|Superiority or Other|||||||0.013|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.|
1719566|NCT00706719|3166172|Superiority or Other|||||||0.705|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.|
1719567|NCT00706719|3166173|Superiority or Other|||||||0.054|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).|
1719568|NCT00706719|3166173|Superiority or Other|||||||0.488|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.|
1719569|NCT00706719|3166173|Superiority or Other|||||||0.612|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.|
1719570|NCT00706719|3166173|Superiority or Other|||||||0.88|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.|
1719571|NCT00706719|3166174|Superiority or Other|||||||0.26|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).|
1719572|NCT00706719|3166174|Superiority or Other|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Month 6.|
1719573|NCT00706719|3166174|Superiority or Other|||||||0.0067|||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Month 3.|
1719574|NCT00706719|3166174|Superiority or Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Comparison of Group A and B observed values at Baseline.|
1719575|NCT00706719|3166175|Superiority or Other|||||||0.0024|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Follow-up (Month 7).|
1719576|NCT00706719|3166175|Superiority or Other|||||||0.009|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 6.|
1719577|NCT00706719|3166175|Superiority or Other|||||||0.006|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Month 3.|
1719578|NCT00706719|3166175|Superiority or Other|||||||0.118|||||||t-test, 2 sided|||Comparison of Group A and B observed values at Baseline.|
1719579|NCT00706654|3166180|Superiority or Other|||||||0.1097|||||||z-statistics||||
1719580|NCT00706654|3166180|Superiority or Other|||||||0.37|||||||z-statistics||||
1719581|NCT00706654|3166181|Superiority or Other|||||||0.0001|||||||z-statistics||||
1719582|NCT00706654|3166181|Superiority or Other|||||||0.875|||||||z-statistics||||
1719583|NCT00706654|3166183|Superiority or Other||Mean Difference (Final Values)|-14.68||||0.0006|2-Sided|95.0|-23.09|-6.27||Once non-inferiority was declared, superiority of depot 300/400 mg over depot 25/50 mg was tested by the difference between the proportion of subjects experiencing impending relapse by the end of Week 26 (2-sided 0.05 significance level z-statistic).|z-statistics|The same method was used to compare IM depot 300 or 400 mg with IM depot 25 or 50 mg in the estimated proportion of subjects with impending relapse.||For the superiority comparison (assay sensitivity analysis) of IM depot 300 or 400 mg to IM depot 25 or 50 mg, on a 2:1 randomization, sample sizes of 260 and 130, respectively, were calculated to provide about 95% power at the 0.05 significance level (2-sided). A superiority margin of 17% was assumed.|
1719584|NCT00706654|3166183|Non-Inferiority or Equivalence|The test of non-inferiority of was performed using a 95% confidence interval (CI, 2-sided) for the difference in the estimated percentage of patients meeting exacerbation of psychotic symptoms/impending relapse criteria by the end of Week 26. Non-inferiority was considered confirmed if the upper bound of the 2-sided 95% CI was below the predefined margin, 11.5%.|Mean Difference (Final Values)|-0.64||||0.7871|2-Sided|95.0|-5.26|3.99|||z-statistics||The 95% CI of the difference in proportions of subjects with impending relapse events between aripiprazole IM depot 300 or 400 mg mg and oral aripiprazole were provided using the pooled SE with assumption of normality of the estimated difference.|Sample sizes were estimated to achieve 93% power for the primary non-inferiority 2-sided comparison at 0.05 significance using large sample normal approximations for the distribution of the difference in binomial proportions. The assumed proportion of impending relapse at or before Week 26 for the oral aripiprazole 10-30 mg arm was 18% and the predefined non-inferiority margin was 11.5%. The sample size was projected to be 260 each for the IM depot 300 or 400 mg and oral 10-30 mg arms.|
1719585|NCT00706641|3166184|Superiority or Other|||||||0.42|||||||paired t-test||||
1719591|NCT00706433|3166237|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719592|NCT00706433|3166238|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719593|NCT00706433|3166239|Superiority or Other|||||||0.3208|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719594|NCT00706433|3166240|Superiority or Other|||||||0.308|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719595|NCT00706433|3166241|Superiority or Other|||||||0.8096|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719596|NCT00706433|3166242|Superiority or Other|||||||0.2908|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719597|NCT00706433|3166243|Superiority or Other|||||||0.3832|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719598|NCT00706433|3166244|Superiority or Other|||||||0.7153|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719599|NCT00706433|3166245|Superiority or Other|||||||0.4814|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719600|NCT00706433|3166246|Superiority or Other|||||||0.0963|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719601|NCT00706433|3166247|Superiority or Other|||||||0.623|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719602|NCT00706433|3166248|Superiority or Other|||||||0.0865|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719603|NCT00706433|3166249|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719604|NCT00706433|3166250|Superiority or Other|||||||0.4235|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719605|NCT00706433|3166251|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719606|NCT00706433|3166251|Superiority or Other|||||||0.0146||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719607|NCT00706433|3166251|Superiority or Other|||||||0.0097||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719608|NCT00706433|3166251|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719609|NCT00706433|3166251|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719610|NCT00706433|3166251|Superiority or Other|||||||0.0245||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719611|NCT00706433|3166251|Superiority or Other|||||||0.0006|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719612|NCT00706433|3166252|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719613|NCT00706433|3166252|Superiority or Other|||||||0.0005||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719614|NCT00706433|3166252|Superiority or Other|||||||0.0004||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719615|NCT00706433|3166252|Superiority or Other|||||||0.0686||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719616|NCT00706433|3166252|Superiority or Other|||||||0.0576||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719617|NCT00706433|3166252|Superiority or Other|||||||0.0255||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719618|NCT00706433|3166252|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719619|NCT00706433|3166253|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719620|NCT00706433|3166253|Superiority or Other|||||||0.0886||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719621|NCT00706433|3166253|Superiority or Other|||||||0.0947||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719622|NCT00706433|3166253|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719623|NCT00706433|3166253|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719624|NCT00706433|3166253|Superiority or Other|||||||0.1261||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719625|NCT00706433|3166253|Superiority or Other|||||||0.0463|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719626|NCT00706433|3166254|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719627|NCT00706433|3166255|Superiority or Other|||||||0.239|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719628|NCT00706433|3166256|Superiority or Other|||||||0.9372||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719629|NCT00706433|3166256|Superiority or Other|||||||0.0022||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719630|NCT00706433|3166256|Superiority or Other|||||||0.002||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719631|NCT00706433|3166256|Superiority or Other|||||||0.0245||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719632|NCT00706433|3166256|Superiority or Other|||||||0.0176||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719633|NCT00706433|3166256|Superiority or Other|||||||0.4091||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719634|NCT00706433|3166256|Superiority or Other|||||||0.0008|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719635|NCT00706433|3166257|Superiority or Other|||||||0.8848|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719636|NCT00706433|3166258|Superiority or Other|||||||0.4575|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719637|NCT00706433|3166259|Superiority or Other|||||||0.0892|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719638|NCT00706433|3166260|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719639|NCT00706433|3166260|Superiority or Other|||||||0.0015||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719640|NCT00706433|3166260|Superiority or Other|||||||0.0012||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719641|NCT00706433|3166260|Superiority or Other|||||||0.0045||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719642|NCT00706433|3166260|Superiority or Other|||||||0.0045||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719643|NCT00706433|3166260|Superiority or Other|||||||0.5313||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719644|NCT00706433|3166260|Superiority or Other|||||||0.0002|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719645|NCT00706433|3166261|Superiority or Other|||||||0.1728|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719646|NCT00706433|3166262|Superiority or Other|||||||0.4753|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719647|NCT00706433|3166263|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719648|NCT00706433|3166263|Superiority or Other|||||||0.0254||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719649|NCT00706433|3166263|Superiority or Other|||||||0.0183||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719650|NCT00706433|3166263|Superiority or Other|||||||0.2207||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719651|NCT00706433|3166263|Superiority or Other|||||||0.3173||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719652|NCT00706433|3166263|Superiority or Other|||||||0.0939||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719653|NCT00706433|3166263|Superiority or Other|||||||0.0064|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719654|NCT00706433|3166264|Superiority or Other|||||||0.5838|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719655|NCT00706433|3166265|Superiority or Other|||||||0.1594|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719656|NCT00706433|3166266|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719657|NCT00706433|3166266|Superiority or Other|||||||0.2039||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719658|NCT00706433|3166266|Superiority or Other|||||||0.1573||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719659|NCT00706433|3166266|Superiority or Other|||||||0.0233||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719660|NCT00706433|3166266|Superiority or Other|||||||0.0179||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719661|NCT00706433|3166266|Superiority or Other|||||||0.2252||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719662|NCT00706433|3166266|Superiority or Other|||||||0.0165|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719663|NCT00706433|3166267|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719664|NCT00706433|3166268|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719665|NCT00706433|3166269|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719666|NCT00706433|3166270|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719667|NCT00706433|3166271|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719668|NCT00706433|3166272|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719669|NCT00706433|3166273|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719670|NCT00706433|3166274|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719671|NCT00706433|3166275|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719672|NCT00706433|3166276|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719673|NCT00706433|3166277|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719674|NCT00706433|3166278|Superiority or Other|||||||0.343|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719675|NCT00706433|3166279|Superiority or Other|||||||0.4378|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719676|NCT00706433|3166280|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719677|NCT00706433|3166281|Superiority or Other|||||||0.1319||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719678|NCT00706433|3166281|Superiority or Other|||||||0.0103||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719898|NCT00702468|3166869|Superiority or Other||Odds Ratio (OR)|18.55||||0.0011|2-Sided|90.0|3.942|118.773|||Regression, Logistic||||
1719679|NCT00706433|3166281|Superiority or Other|||||||0.1835||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719680|NCT00706433|3166281|Superiority or Other|||||||0.2804||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719681|NCT00706433|3166281|Superiority or Other|||||||0.447||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719682|NCT00706433|3166281|Superiority or Other|||||||0.0564||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719683|NCT00706433|3166281|Superiority or Other|||||||0.0301|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719684|NCT00706433|3166282|Superiority or Other|||||||0.548|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719685|NCT00706433|3166283|Superiority or Other|||||||0.0728|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719686|NCT00706433|3166284|Superiority or Other|||||||0.4965|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719687|NCT00706433|3166285|Superiority or Other|||||||0.782|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719688|NCT00706433|3166286|Superiority or Other|||||||0.526||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719689|NCT00706433|3166286|Superiority or Other|||||||0.0089||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719690|NCT00706433|3166286|Superiority or Other|||||||0.0019||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719691|NCT00706433|3166286|Superiority or Other|||||||0.0513||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719692|NCT00706433|3166286|Superiority or Other|||||||0.0209||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719693|NCT00706433|3166286|Superiority or Other|||||||0.6116||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719694|NCT00706433|3166286|Superiority or Other|||||||0.0047|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719695|NCT00706433|3166287|Superiority or Other|||||||0.6907|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719696|NCT00706433|3166288|Superiority or Other|||||||0.9886|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719697|NCT00706433|3166289|Superiority or Other|||||||0.0781||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719698|NCT00706433|3166289|Superiority or Other|||||||0.2142||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719699|NCT00706433|3166289|Superiority or Other|||||||0.0029||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719700|NCT00706433|3166289|Superiority or Other|||||||0.7426||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719701|NCT00706433|3166289|Superiority or Other|||||||0.0395||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719702|NCT00706433|3166289|Superiority or Other|||||||0.5818||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719703|NCT00706433|3166289|Superiority or Other|||||||0.0317|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719704|NCT00706433|3166290|Superiority or Other|||||||0.4321|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719705|NCT00706433|3166291|Superiority or Other|||||||0.2544|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719706|NCT00706433|3166292|Superiority or Other|||||||0.97||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719899|NCT00702468|3166870|Superiority or Other||Odds Ratio (OR)|4.562||||0.017|2-Sided|90.0|1.585|13.997|||Regression, Logistic||||
1719707|NCT00706433|3166292|Superiority or Other||||||<|0.0001||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719708|NCT00706433|3166292|Superiority or Other||||||<|0.0001||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719709|NCT00706433|3166292|Superiority or Other||||||<|0.0003||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719710|NCT00706433|3166292|Superiority or Other||||||<|0.0005||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719711|NCT00706433|3166292|Superiority or Other||||||<|0.4143||||||Not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719712|NCT00706433|3166292|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719713|NCT00706433|3166293|Superiority or Other|||||||0.1489|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719714|NCT00706433|3166294|Superiority or Other|||||||0.8387|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719715|NCT00706433|3166295|Superiority or Other|||||||0.3916|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719716|NCT00706433|3166296|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719717|NCT00706433|3166297|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719718|NCT00706433|3166298|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719719|NCT00706433|3166299|Superiority or Other|||||||0.308|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719720|NCT00706433|3166300|Superiority or Other|||||||0.3666|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719721|NCT00706433|3166301|Superiority or Other|||||||0.8679|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719722|NCT00706433|3166302|Superiority or Other|||||||0.5812|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719723|NCT00706433|3166303|Superiority or Other|||||||0.4096|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719724|NCT00706433|3166304|Superiority or Other|||||||0.4754|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719725|NCT00706433|3166305|Superiority or Other|||||||0.5759|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.|
1719726|NCT00706433|3166306|Superiority or Other|||||||0.3416|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates|
1719727|NCT00706433|3166307|Superiority or Other|||||||0.7228|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Null hypothesis: equal success rates.|
1719728|NCT00706433|3166308|Superiority or Other|||||||0.1103|||||||ANCOVA|Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.||Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments|
1719729|NCT00706433|3166310|Superiority or Other||||||>|0.1|||||||ANOVA|Rank transformed data.||Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments|
1719730|NCT00706433|3166311|Superiority or Other||||||>|0.1|||||||ANOVA|Rank transformed data.||Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatments|
1719731|NCT00706433|3166312|Superiority or Other|||||||0.7975|||||||Cochran-Mantel-Haenszel|Stratified by study center.||Null hypothesis: equal success rates.|
1719732|NCT00706433|3166313|Superiority or Other|||||||0.768|||||||ANCOVA|Rank ANCOVA with baseline total inflammatory lesion counts serving as the covariate.||Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatments|
1719733|NCT00706121|3166356|Superiority or Other (legacy)||Risk Ratio (RR)|1.03||||0.38|2-Sided|95.0|0.96|1.1|||Log binomial regression||||
1719734|NCT00706121|3166357|Superiority or Other (legacy)||Risk Ratio (RR)|0.91||||0.24|2-Sided|95.0|0.77|1.07|||Log binomial regression||||
1719735|NCT00706121|3166359|Superiority or Other (legacy)||Risk Ratio (RR)|0.92||||0.32|2-Sided|95.0|0.78|1.08|||Log binomial regression||||
1719736|NCT00706121|3166360|Superiority or Other (legacy)||Risk Ratio (RR)|0.96||||0.96|2-Sided|95.0|0.9|1.02|||Log binomial regression||||
1719737|NCT00705783|3166400|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1719738|NCT00705783|3166401|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1719739|NCT00705783|3166402|Superiority or Other||Mean Difference (Final Values)|-1.36||||0.0001|2-Sided|95.0|-2.04|-0.67|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.|||
1719740|NCT00705783|3166403|Superiority or Other||Mean Difference (Final Values)|-3.82|||<|0.0001|2-Sided|95.0|-4.72|-2.91|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.||Positive Subscale Score|
1719741|NCT00705783|3166404|Superiority or Other||Mean Difference (Final Values)|-0.52|||<|0.0001|2-Sided|95.0|-0.7|-0.35|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.|||
1719742|NCT00705783|3166405|Superiority or Other||Mean Difference (Final Values)|-10.11|||<|0.0001|2-Sided|95.0|-12.68|-7.54|||ANCOVA|The ANCOVA included treatment as a term and baseline as a covariate.|||
1719743|NCT00705783|3166406|Superiority or Other|||||||0.1756|||||||Chi-squared||||
1719744|NCT00705783|3166407|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1719745|NCT00705783|3166408|Superiority or Other||||||<|0.0001||||||The alpha levels for this key secondary Outcome Measure were the same as used for the primary Outcome Measure.|Chi-squared||||
1719746|NCT00705783|3166409|Superiority or Other||Hazard Ratio (HR)|0.199|||<|0.0001|2-Sided|95.0|0.125|0.317|||Log Rank||Aripiprazole depot/placebo depot|Based on 6-month IR rates of 55% for placebo and 35% for aripiprazole, sample sizes were estimated to achieve 90% power to detect a hazard ratio of 0.54 and to preserve an overall nominal alpha level of 0.05 (2-sided), allowing for 2 interim looks at 50% and 75% of events. Assuming that each subject was followed for 12 months after randomization and allowing for a 25% loss to follow-up, the projected total number of subjects to be randomly assigned to treatment in the trial was 225.|
1719747|NCT00705757|3166410|Superiority or Other|||||||0.851|||||||ANOVA|||One way ANOVA of cheek/face|
1719748|NCT00705757|3166410|Superiority or Other|||||||0.23|||||||ANOVA|||One way ANOVA of Lower Lid|
1719749|NCT00705757|3166410|Superiority or Other|||||||0.769|||||||ANOVA|||One way ANOVA of Upper Lid|
1719750|NCT00705679|3166417|Superiority or Other|||||||0.004|||||||Fisher Exact|Two-sided Fisher's Exact Test.|||
1719751|NCT00705679|3166418|Superiority or Other||Hazard Ratio (HR)|1.04||||0.81|2-Sided|95.0|0.73|1.49||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.|
1719752|NCT00705679|3166421|Superiority or Other||Hazard Ratio (HR)|1.49||||0.07|2-Sided|95.0|0.97|2.29||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.|
1719753|NCT00705679|3166424|Superiority or Other||Hazard Ratio (HR)|0.85||||0.37|2-Sided|95.0|0.61|1.21||The two-sided test a priori threshold for statistical significance is 0.05 against an alternative of 0% effectiveness for estimated effectiveness levels between 33.3% and 50.0%.|Regression, Cox|The Cox proportional-hazards model was stratified by site.|A ratio less than 1 indicates a lower rate of HIV infection in the active arm compared to the placebo arm. A ratio more than 1 indicates a higher rate of HIV infection in the active arm compared to the placebo arm.|The null hypothesis is that the active product will be no more than 25% effective. The trial was designed so that 94 events per pairwise comparison are needed to detect 55% effectiveness while ruling out a lower effectiveness of 25% with 90% power and a false-positive error rate of 0.0025.|
1719754|NCT00705536|3166454|Superiority or Other|||||||0.0067||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA||||
1719755|NCT00705536|3166454|Superiority or Other|||||||0.5589||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA||||
1719756|NCT00705536|3166456|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA||||
1719757|NCT00705536|3166456|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humalog alone and Humalog +rHuPH20 using a pairwise t-test.|ANOVA||||
1719758|NCT00705536|3166457|Superiority or Other|||||||0.0004||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA||||
1719759|NCT00705536|3166457|Superiority or Other|||||||0.0401||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA||||
1719760|NCT00705536|3166458|Superiority or Other|||||||0.3019||||||Treatment comparison for Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA||||
1719761|NCT00705536|3166459|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA||||
1719762|NCT00705536|3166459|Superiority or Other||||||<|0.0002||||||Treatment comparison for Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA||||
1719763|NCT00705536|3166460|Superiority or Other|||||||0.0105||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA||||
1719764|NCT00705536|3166460|Superiority or Other|||||||0.0059||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA||||
1719765|NCT00705536|3166461|Superiority or Other||||||<|0.0001||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA||||
1719766|NCT00705536|3166461|Superiority or Other||||||<|0.0003||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA||||
1719767|NCT00705536|3166462|Superiority or Other|||||||0.0002||||||Treatment comparison of Humulin-R alone and Humulin-R + rHuPH20 using a pairwise t-test.|ANOVA||||
1719768|NCT00705536|3166462|Superiority or Other|||||||0.0006||||||Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test.|ANOVA||||
1719769|NCT00705523|3166464|Superiority or Other|||||||0.1|||||||Regression, Logistic|beta=-0.67, exp(beta)=0.51, chi-squared(1) = 0.2.71||Self-reported drinking results, as gathered by the TLFB, were compared by the generalized estimating equations (GEE) (Diggle et al., 1994), using Poisson models for counts of drinking and heavy drinking days, and logistic regression models for absence/presence binary indicators of drinking. In the GEE model, the pre-treatment of the response was included as a covariate, together with the treatment group indicator, and a linear time effect.|
1719770|NCT00705432|3166469|Superiority or Other||The difference in SVR|27.2||||0.0107|2-Sided|95.0|9.0|45.3|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).|||
1719771|NCT00705432|3166469|Superiority or Other||The difference in SVR|21.3||||0.0366|2-Sided|95.0|2.3|40.2|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for the baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).|||
1719772|NCT00705432|3166469|Superiority or Other||The difference in SVR rates|29.1|||<|0.0001|2-Sided|95.0|21.5|36.8|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).|||
1719773|NCT00705432|3166469|Superiority or Other||The difference in SVR rates|27.5|||<|0.0001|2-Sided|95.0|19.2|35.2|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).|||
1719774|NCT00705432|3166470|Superiority or Other||The difference in SVR|29.7||||0.0035|2-Sided|95.0|12.2|47.1|||Cochran-Mantel Haenszel Chi-square|Adjustments were made for the baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).|||
1719775|NCT00705432|3166470|Superiority or Other||The difference in SVR|19.2||||0.044|2-Sided|95.0|1.6|36.9|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for the baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).|||
1719776|NCT00705432|3166470|Superiority or Other||The difference in SVR|28.3|||<|0.0001|2-Sided|95.0|20.8|35.8|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).|||
1719777|NCT00705432|3166470|Superiority or Other||The difference in SVR|26.6|||<|0.0001|2-Sided|95.0|19.1|34.1|||Cochran-Mantel Haenszel Chi-square test|Adjustments were made for for baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).|||
1719778|NCT00705406|3166475|Superiority or Other|||||||0.306|||||||Cochran-Mantel-Haenszel|P-value is based on the Cochran-Mantel-Haenszel general association test controlling for smoking status and hemisphere of enrollment.|||
1719779|NCT00705406|3166476|Superiority or Other|||||||0.885|||||||Wilcoxon-Gehan test statistic|P-values are from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.|||
1719780|NCT00705406|3166477|Superiority or Other|||||||0.421|||||||van Elteren test|P-value is based on van Elteren test controlling for smoking status and hemisphere of enrollment.|||
1719781|NCT00705406|3166478|Superiority or Other||||||>|0.05|||||||van Elteren test|P-value for comparisons at all time points. P-value was based on the van Elteren test controlling for smoking status and hemisphere of enrollment.|||
1719782|NCT00705406|3166479|Superiority or Other||Hazard Ratio (HR)|0.927||||0.222|2-Sided|95.0|0.723|1.188|||Wilcoxon-Gehan test statistic|P-value is from a Wilcoxon-Gehan test statistic controlling for smoking status and hemisphere of enrollment.|Hazard Ratio and corresponding 95% CI are based the Cox Regression Model including parameters for treatment, controlling for smoking status and hemisphere of enrollment.||
1719783|NCT00705341|3166495|Superiority or Other|||||||0.65|||||||Regression, Linear|||Log-linear generalized estimating equation (GEE) models were used to assess the dose effect on PC20.|
1719784|NCT00705289|3166496|Superiority or Other||Mean Baseline DAS28 Raw Score|5.3|Standard Deviation|1.16||||95.0|5.1|5.5||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA who failed or did not tolerate another anti-TNF; prior to infliximab therapy)|
1719785|NCT00705289|3166496|Superiority or Other||Mean Baseline DAS28 Raw Score|5.2|Standard Deviation|1.14||||95.0|5.1|5.3||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with established RA not treated with anti-TNF; prior to infliximab therapy)|
1719786|NCT00705289|3166496|Superiority or Other||Mean Baseline DAS28 Raw Score|5.3|Standard Deviation|1.16||||95.0|5.0|5.5||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (subjects with early RA, not treated with anti-TNF; prior to infliximab therapy)|
1719787|NCT00705289|3166496|Superiority or Other||Mean Baseline DAS28 Raw Score|5.2|Standard Deviation|1.15||||95.0|5.1|5.3||||||Relationship between Baseline DAS28 and previous anti-TNF therapy (all subjects, prior to infliximab therapy)|
1719788|NCT00705289|3166497|Superiority or Other||||||<|0.0001|||||||ANOVA|Relationship between DAS28 and Country of Residence was based on a 1-way ANOVA calculated as P-value.||Relationship between baseline DAS28 and country of residence (prior to infliximab therapy)|
1719789|NCT00705289|3166498|Superiority or Other|||||||0.7152|||||||ANOVA|The association between Baseline DAS28 and gender is based on a one-way Anova.||Relationship between baseline DAS28 and gender (prior to infliximab therapy)|
1719790|NCT00705289|3166499|Superiority or Other||Pearson Product Moment Correlation|-0.01||||0.7991||95.0|||||Test for non-zero correlation|||Relationship between baseline DAS28 and time since diagnosis (prior to infliximab therapy)|
1719791|NCT00705289|3166500|Superiority or Other||Pearson Product Moment Correlation|0.1402||||0.0003|||||||Test for non-zero correlation|||Relationship between baseline DAS28 and age (prior to infliximab therapy)|
1719792|NCT00705016|3166519|Superiority or Other||Hazard Ratio (HR)|2.6||||0.007|2-Sided|95.0|1.3|5.21||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model||||
1719793|NCT00705016|3166519|Superiority or Other||Hazard Ratio (HR)|1.3||||0.391|2-Sided|95.0|0.71|2.39||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model||||
1720022|NCT00699907|3167266|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test||||
1719794|NCT00705016|3166520|Superiority or Other||Hazard Ratio (HR)|1.73||||0.007|2-Sided|95.0|1.16|2.57||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model||||
1719795|NCT00705016|3166520|Superiority or Other||Hazard Ratio (HR)|1.23||||0.294|2-Sided|95.0|0.84|1.81||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model||||
1719796|NCT00705016|3166521|Superiority or Other||Odds Ratio (OR)|0.668||||0.347|2-Sided|95.0|0.287|1.555||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel||||
1719797|NCT00705016|3166521|Superiority or Other||Odds Ratio (OR)|1.396||||0.476|2-Sided|95.0|0.551|3.539||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel||||
1719798|NCT00705016|3166522|Superiority or Other||Odds Ratio (OR)|0.671||||0.317|2-Sided|95.0|0.307|1.465||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel||||
1719799|NCT00705016|3166522|Superiority or Other||Odds Ratio (OR)|1.595||||0.205|2-Sided|95.0|0.776|3.276||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cochran-Mantel-Haenszel||||
1719800|NCT00705016|3166523|Superiority or Other||Hazard Ratio (HR)|1.04||||0.878|2-Sided|95.0|0.66|1.63|||Cox proportional hazards model||||
1719801|NCT00705016|3166523|Superiority or Other||Hazard Ratio (HR)|0.94||||0.8|2-Sided|95.0|0.61|1.47||Secondary analyses of efficacy were performed to support the results of the primary analysis and considered as purely exploratory and no adjustment for multiplicity has been done.|Cox proportional hazards model||||
1719802|NCT00705016|3166524|Superiority or Other||Hazard Ratio (HR)|1.55||||0.054|2-Sided|95.0|0.99|2.43||The Type I error was not taken into account, since the sample size calculation is based on selection theory.|Cox proportional hazards model|Stratification factor: Karnofsky performance status (KPS) <80/>=80||Sample size of 177 subjects was estimated such that the treatment group with the best PFS result had a 90% probability of emerging as the one with the smaller observed log HR, if there was an underlying difference of 2.2 months between the arms in the median PFS (7.8 months in the best group and 5.6 months in the other 2 groups). It was assumed that the accrual and follow-up time would take 1 year each, and that the drop-out rate was 8%.|
1719803|NCT00705016|3166524|Superiority or Other||Hazard Ratio (HR)|1.03||||0.885|2-Sided|95.0|0.67|1.59||The Type I error was not taken into account, since the sample size calculation is based on selection theory.|Cox proportional hazards model|Stratification factor: Karnofsky performance status (KPS) <80/>=80||Sample size of 177 subjects was estimated such that the treatment group with the best PFS result had a 90% probability of emerging as the one with the smaller observed log Hazard ratio (HR), if there was an underlying difference of 2.2 months between the arms in the median PFS (7.8 months in the best group and 5.6 months in the other 2 groups). It was assumed that the accrual and follow-up time would take 1 year each, and that the drop-out rate was 8%.|
1719804|NCT00704912|3166534|Superiority or Other|||||||0.22|||||||GEE||||
1719805|NCT00704912|3166534|Superiority or Other|||||||0.001|||||||GEE||||
1719806|NCT00704912|3166534|Superiority or Other|||||||0.08|||||||GEE||||
1719807|NCT00704912|3166534|Superiority or Other||Odds Ratio (OR)|0.7||||0.18|2-Sided|95.0|0.4|1.2|||GEE||End of intervention compared to baseline|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.|
1719808|NCT00704912|3166534|Superiority or Other||Odds Ratio (OR)|2.5||||0.001|2-Sided|95.0|1.4|4.3|||GEE||End of intervention compared to baseline|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.|
1719809|NCT00704912|3166534|Superiority or Other||Odds Ratio (OR)|1.2||||0.6|2-Sided|95.0|0.6|2.2|||GEE||End of intervention compared to baseline.|Comparing change in prevalence of metabolic syndrome from baseline to the end of intervention.|
1719810|NCT00704912|3166535|Superiority or Other||Difference in Mean Change|-0.1||||0.92|2-Sided|95.0|-1.3|1.2|||Mixed Models Analysis||Lifestyle vs. Combined||
1719811|NCT00704912|3166535|Superiority or Other||Difference in Mean Change|-5.0|||<|0.0001|2-Sided|95.0|-6.2|-3.7|||Mixed Models Analysis||Combined vs. OCP||
1719812|NCT00704912|3166535|Superiority or Other||Difference in Mean Change|-5.0|||<|0.0001|2-Sided|95.0|-6.3|-3.8|||Mixed Models Analysis||Lifestyle vs. OCP||
1719813|NCT00704912|3166536|Superiority or Other||Risk Ratio (RR)|0.9||||0.28|2-Sided|95.0|0.7|1.1|||Log-binomial model||||
1719814|NCT00704912|3166536|Superiority or Other||Risk Ratio (RR)|1.5||||0.002|2-Sided|95.0|1.1|1.9|||Log-binomial model||||
1719815|NCT00704912|3166536|Superiority or Other||Risk Ratio (RR)|1.3||||0.06|2-Sided|95.0|1.0|1.7|||Log-binomial model||||
1719816|NCT00704912|3166537|Superiority or Other||Risk Ratio (RR)|1.1||||0.82|2-Sided|95.0|0.5|2.1|||Log-binomial model||||
1719817|NCT00704912|3166537|Superiority or Other||Risk Ratio (RR)|2.3||||0.08|2-Sided|95.0|0.9|6.1|||Log-binomial model||||
1719818|NCT00704912|3166537|Superiority or Other||Risk Ratio (RR)|2.5||||0.06|2-Sided|95.0|1.0|6.6|||Log-binomial model||||
1719819|NCT00704405|3166570|Superiority or Other||Adjusted difference in percentage|35.8|||||2-Sided|95.0|15.5|53.4|||||Adjusted difference subtracts the percentage of PBO patients (36.6%) with undetectable HCV RNA at Week 48 and stratifies by prior treatment response.||
1719820|NCT00704405|3166571|Superiority or Other||Adjusted difference in percentage|76.1|||||2-Sided|95.0|60.1|86.7|||||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.||
1719821|NCT00704405|3166571|Superiority or Other||Adjusted difference in percentage|82.6|||||2-Sided|95.0|69.5|90.2|||||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.||
1719822|NCT00704405|3166572|Superiority or Other||Adjusted difference in percentage|47.3|||<|0.001|2-Sided|95.0|29.2|63.2|||Miettinen and Nurminen||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.||
1719823|NCT00704405|3166575|Superiority or Other||Adjusted difference in percentage|59.0|||<|0.001|2-Sided|95.0|40.2|73.4|||Miettinen and Nurminen||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.||
1719824|NCT00704405|3166575|Superiority or Other||Adjusted difference in percentage|64.4|||<|0.001|2-Sided|95.0|45.2|78.3|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.||
1719825|NCT00704405|3166575|Superiority or Other||Adjusted difference in percentage|53.6|||<|0.001|2-Sided|95.0|34.5|69.1|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.||
1719826|NCT00704379|3166581|Superiority or Other||Hazard Ratio (HR)|3.6|||<|0.05|2-Sided|95.0|1.1|16.2|||Log Rank||||
1719827|NCT00704340|3166583|Superiority or Other|||||||0.619|||||||t-test, 2 sided||||
1719828|NCT00704340|3166584|Superiority or Other|||||||0.681|||||||t-test, 2 sided||||
1719829|NCT00704340|3166585|Superiority or Other|||||||0.613|||||||t-test, 2 sided|||The sample size was selected to provide sufficient precision for 95% confidence intervals for the incidence of neurosurgical complications in each arm. The sample size was selected so that the half-width of the normal approximation-based intervals would be no more than 0.05 percentage points. This requires a sample size of 114 evaluable patients in each arm. To allow for loss to follow-up, the sample size was increased to 125 randomized patients in each treatment arm, or a total of 250 patients.|
1719830|NCT00704184|3166586|Superiority or Other||Difference in LS Means|-2.7|||||2-Sided|95.0|-3.3|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.||
1719831|NCT00704184|3166586|Superiority or Other||Difference in LS Means|-2.7|||||2-Sided|95.0|-3.4|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.||
1719832|NCT00704184|3166586|Superiority or Other||Difference in LS Means|-2.7|||||2-Sided|95.0|-3.4|-2.0|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.||
1719833|NCT00704184|3166586|Superiority or Other||Difference in Least Squares (LC) Means|-2.5|||||2-Sided|95.0|-3.2|-1.8|||||The difference in LS Means reflects the mean decrease from baseline in HCV RNA between vaniprevir and placebo at Week 4.||
1719834|NCT00704184|3166587|Superiority or Other||Adjusted difference|10.7|||||2-Sided|95.0|-11.4|34.6|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).||
1719835|NCT00704184|3166587|Superiority or Other||Adjusted difference|16.9|||||2-Sided|95.0|-4.0|40.2|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).||
1719836|NCT00704184|3166587|Superiority or Other||Adjusted difference|16.2|||||2-Sided|95.0|-2.2|39.5|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).||
1719837|NCT00704184|3166587|Superiority or Other||Adjusted difference|16.9|||||2-Sided|95.0|-4.0|40.2|||||Adjusted difference subtracts the percentage of placebo responders (83.3%) and stratifies by HCV genotype (1a vs. non-1a).||
1719838|NCT00704184|3166588|Superiority or Other||Adjusted difference|5.4|||||2-Sided|95.0|-16.5|28.4|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).||
1719839|NCT00704184|3166588|Superiority or Other||Adjusted difference|11.2|||||2-Sided|95.0|-9.7|33.8|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).||
1719840|NCT00704184|3166588|Superiority or Other||Adjusted difference|10.8|||||2-Sided|95.0|-7.6|33.2|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).||
1719841|NCT00704184|3166588|Superiority or Other||Adjusted difference|11.2|||||2-Sided|95.0|-9.7|33.8|||||Adjusted difference subtracts the percentage of placebo responders (88.9%) and stratifies by HCV genotype (1a vs. non-1a).||
1719842|NCT00704184|3166591|Superiority or Other||Adjusted difference in %|77.8|||<|0.001|2-Sided|95.0|49.2|91.3|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3) and stratifies by HCV genotype (1a vs. non-1a).||
1719843|NCT00704184|3166591|Superiority or Other||Adjusted difference in %|63.3|||<|0.001|2-Sided|95.0|32.8|82.7|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).||
1719844|NCT00704184|3166591|Superiority or Other||Adjusted difference in %|73.6|||<|0.001|2-Sided|95.0|46.0|88.6|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).||
1719845|NCT00704184|3166591|Superiority or Other||Adjusted difference in %|69.3|||<|0.001|2-Sided|95.0|40.3|86.7|||Miettinen and Nurminen method||Adjusted difference subtracts the percentage of placebo responders (5.3%) and stratifies by HCV genotype (1a vs. non-1a).||
1719846|NCT00704171|3166592|Superiority or Other|||||||0.013||||||For subgroup with pre-randomization air leak grade of 2 or 3|Fisher Exact||||
1719847|NCT00704171|3166592|Superiority or Other|||||||0.53||||||For subgroup with pre-randomization air leak grade of 1|Fisher Exact||||
1719848|NCT00704171|3166593|Superiority or Other|||||||0.292|||||||2-sample t-test||||
1719849|NCT00704171|3166594|Superiority or Other|||||||0.559|||||||2-sample t-test||||
1719850|NCT00704171|3166595|Superiority or Other|||||||0.79|||||||Kaplan-Meier|Kaplan-Meier method was used to obtain estimated median times for each treatment group and the log-rank test was used to compare the two treatments.|||
1719851|NCT00704171|3166596|Superiority or Other||||||<|0.001|||||||Fisher Exact|two-sided|||
1719900|NCT00702468|3166871|Superiority or Other||treatment difference|-0.64||||0.271|2-Sided|90.0|-1.6|0.33|||ANCOVA||A negative difference indicates the comparison is in favour of Sativex||
1719852|NCT00704171|3166597|Superiority or Other|||||||0.257|||||||Fisher Exact|||Primary objective was to demonstrate superiority of PleuraSeal as an adjunct compared to standard of care alone. Tissue closure rates for the treatment and control groups were assumed to be 0.40 and 0.15, respectively. To achieve 80 percent power (alpha=0.05, 2-tailed, Fisher's Exact Test) required 112 completed subjects. To account for potential subject withdrawals, an additional 8 subjects were to be enrolled for a total of 120 randomized subjects (approx. 60 per treatment group).|
1719853|NCT00704132|3166598|Superiority or Other||Difference in Least-Squares Mean|-111.0|||<|0.001||95.0|-158.0|-63.9|||ANCOVA||Sitagliptin minus Placebo||
1719854|NCT00703963|3166602|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p < 0.05.|
1719855|NCT00703963|3166603|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p < 0.05.|
1719856|NCT00703963|3166604|Superiority or Other|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Statistical significance was defined as p < 0.05.|
1719857|NCT00703820|3166651|Superiority||Odds Ratio (OR)|1.87||||0.035|2-Sided|95.0|1.03|3.41||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.0429 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.|Cochran-Mantel-Haenszel|The p-value was computed using an exact, risk-group stratified, two-sided test.|The odds ratio is defined as the ratio of the odds that a Clofarabine+Cytarabine patient is MRD positive to the odds that a Cytarabine+Daunorubicin+Etoposide patient is MRD positive.|The study was designed to test the null hypothesis that Cytarabine+Daunorubicin+Etoposide and Clofarabine+Cytarabine result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 240 MRD-evaluable patients in a 5-stage Haybittle-Peto group sequential design gives 80% power at the 5% level to detect an odds ratio of 2.5. The design was developed using East statistical software.|
1719858|NCT00703508|3166685|Superiority or Other|||||||0.1586||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p < 0.05.|Regression, Linear||||
1719859|NCT00703508|3166685|Superiority or Other|||||||0.0311||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p < 0.05.|Regression, Linear||||
1719860|NCT00703508|3166685|Superiority or Other|||||||0.118||||||Ovulation rate vs Matsuda Index post-treatment, threshold for statistical significance = p < 0.05.|Regression, Linear||||
1719861|NCT00703508|3166685|Superiority or Other|||||||0.4698||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p<0.05|Regression, Linear||||
1719862|NCT00703508|3166685|Superiority or Other|||||||0.074||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p<0.05|Regression, Linear||||
1719863|NCT00703508|3166685|Superiority or Other|||||||0.0234||||||Ovulation rate vs Testosterone post-treatment, threshold for statistical significance = p<0.05|Regression, Linear||||
1719864|NCT00703326|3166712|Superiority or Other (legacy)|||||||0.539||||||P-value is for end of therapy. Analysis of covariance (ANCOVA) adjusted for baseline score was used to compare the 2 treatment arms.|ANCOVA||||
1719865|NCT00703326|3166713|Superiority or Other (legacy)||Hazard Ratio (HR)|0.84||||0.15|2-Sided|95.0|0.67|1.06|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.||
1719866|NCT00703326|3166714|Superiority or Other (legacy)||Odds Ratio (OR)|1.33||||0.027||95.0|1.03|1.71|||Stratified Cochran-Mantel-Haenszel(SCMH)|SCMH used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|Stratified odds ratio was calculated considering the IWRS stratification factors.||
1719867|NCT00703326|3166715|Superiority or Other (legacy)||Hazard Ratio (HR)|0.85||||0.033|2-Sided|95.0|0.73|0.99|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.||
1719868|NCT00703326|3166716|Superiority or Other (legacy)||Hazard Ratio (HR)|1.01||||0.915|2-Sided|95.0|0.83|1.23||The gate-keeping strategy used to control overall type 1 error 0.05 (2-sided) or 0.025 (1-sided) to analyze progression-free survival (PFS) and OS. At final PFS analysis only if primary PFS test was significant would analysis of OS be inferential.|Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.||
1719869|NCT00703326|3166717|Superiority or Other (legacy)||Hazard Ratio (HR)|0.88||||0.077|2-Sided|95.0|0.75|1.01|||Stratified Log Rank (SLR)|SLR used Interactive Web Response System (IWRS) factors: prior taxane therapy, visceral metastasis, hormone receptor status and geographical regions.|HR with 95% confidence interval (CI) was estimated using a stratified Cox proportional hazards regression model using the IWRS stratification factors.||
1719870|NCT00703261|3166718|Superiority or Other|||||||0.195|||||||cLDA||||
1719871|NCT00703261|3166719|Superiority or Other||Percent Reduction|4.5||||0.088|2-Sided|90.0|-1.0|9.6|||cLDA||||
1719872|NCT00703261|3166719|Superiority or Other|||||||0.277|||||||cLDA||||
1719873|NCT00703261|3166719|Superiority or Other|||||||0.006|||||||cLDA|||Constrained longitudinal data analysis (cLDA)|
1719901|NCT00702468|3166872|Superiority or Other||Slope|-1.78||||0.81|2-Sided|90.0|-14.52|10.96|||ANCOVA||Negative difference indicates the comparison is in favour of Sativex|It is important to emphasise that only four placebo subjects were included in the analysis and 11 of the Sativex subjects - this sample size is too small for a meaningful comparison between treatments. The reason for not including some of the data in this analysis is that a number of the subjects who withdrew early from the study restarted their own Sativex before the assessment was done.|
1719902|NCT00702468|3166874|Superiority or Other||Treatment difference|0.53||||0.86|2-Sided|90.0|-4.68|5.74|||ANCOVA||||
1719903|NCT00702468|3166875|Superiority or Other||Estimated treatment difference|-0.21||||0.72|2-Sided|90.0|-1.22|0.79|||ANCOVA||Negative difference indicates the comparison is in favour of Sativex||
1719874|NCT00703118|3166738|Superiority or Other||Difference in percentage of response|49.8|||<|0.001|2-Sided|95.0|39.9|59.7||Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure|Regression, Logistic|Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate|Difference in percentage of response was estimated through the logistic regression model.|Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48 or T12(DS)/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12(DS)/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.|
1719875|NCT00703118|3166738|Superiority or Other||Difference in percentage of response|46.8|||<|0.001|2-Sided|95.0|36.8|56.7||Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure|Regression, Logistic|Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate|Difference in percentage of response was estimated through the logistic regression model.|Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.|
1719876|NCT00702949|3166772|Superiority or Other|||||||0.007|||||||t-test, 2 sided|||Comparing the median percent change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.|
1719877|NCT00702949|3166774|Superiority or Other|||||||0.009|||||||t-test, 2 sided|||Comparing the median percent change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.|
1719878|NCT00702949|3166775|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||Comparing the median numerical change from baseline on hot flash score for Pregabalin 75 Mg with the Placebo.|
1719879|NCT00702949|3166778|Superiority or Other|||||||0.007|||||||t-test, 2 sided|||Comparing the median numerical change from baseline on hot flash score for Pregabalin 150 Mg with the Placebo.|
1719880|NCT00702845|3166805|Non-Inferiority or Equivalence|Equivalence margins of -3 and +5 were applied for the difference in the mean number of oocytes between the treatment groups. Org 36286 treatment was considered equivalent to the reference treatment (recFSH) if the two-sided 95% confidence interval of the difference was between -3 and +5 oocytes.|Mean Difference (Final Values)|2.5|||<|0.001|2-Sided|95.0|1.2|3.9|||ANOVA||||
1719881|NCT00702715|3166816|Non-Inferiority or Equivalence|For the secondary endpoint no equivalence margin was specified (i.e., no formal null-hypothesis was specified); the median difference and associated 95% CI were to further characterize the efficacy of severe renal impaired subjects and controls.|Median Difference (Final Values)|60.0|||||2-Sided|95.0|31.0|103.0|||||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)||
1719882|NCT00702715|3166817|Non-Inferiority or Equivalence|For the secondary endpoint no equivalence margin was specified (i.e., no formal null-hypothesis was specified); the median difference and associated 95% CI were to further characterize the efficacy of severe renal impaired subjects and controls.|Median Difference (Final Values)|68.0|||||2-Sided|95.0|36.0|120.0|||||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)||
1719883|NCT00702715|3166818|Non-Inferiority or Equivalence|The 95% confidence interval for the estimated median treatment difference in recovery time must have fallen entirely within the pre-specified interval between -60 sec to +60 sec in order to claim equivalence|Median Difference (Final Values)|78.0|||||2-Sided|95.0|36.0|143.0|||||Estimated median treatment difference (severe renal impairment minus normal renal function) in recovery time (seconds)||
1719884|NCT00702689|3166821|Superiority or Other (legacy)|||||||0.29|||||||t-test, 2 sided||||
1719885|NCT00702689|3166822|Superiority or Other (legacy)|||||||0.47|||||||t-test, 2 sided||||
1719886|NCT00702689|3166824|Superiority or Other (legacy)|||||||0.011|||||||Paired t-test||||
1719887|NCT00702650|3166836|Superiority or Other||||||<|0.0001||||||p-value for Mental Component Score based on a one-sample t-test comparing Day 120 and Baseline values.|t-test, 2 sided||||
1719888|NCT00702650|3166836|Superiority or Other||||||<|0.0254||||||p-value for Physical Component Score based on a one-sample t-test comparing Day 120 and Baseline values.|t-test, 2 sided||||
1719889|NCT00702650|3166837|Superiority or Other||||||<|0.0001||||||P-value is for Negative Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided||||
1719890|NCT00702650|3166837|Superiority or Other||||||<|0.0001||||||P-value is for Positive Mood based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided||||
1719891|NCT00702650|3166837|Superiority or Other||||||<|0.0001||||||P-value is for Erection Maintained for Satisfactory Duration based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided||||
1719892|NCT00702650|3166837|Superiority or Other||||||<|0.0001||||||P-value is for Overall Sexual Activity Score based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided||||
1719893|NCT00702650|3166837|Superiority or Other||||||<|0.0001||||||P-value is for Sexual Desire based on a two-sided, paired t-test comparing the Baseline and the Day 120 scores.|t-test, 2 sided||||
1719894|NCT00702650|3166842|Superiority or Other||||||<|0.001|||||||One-Sample Binomial (Wald) test, 2-sided||||
1719895|NCT00702546|3166854|Superiority or Other||Risk Difference (RD)|-9.4|||||2-Sided|95.0|-19.5|0.7||||||Treatment groups were compared with a generalized linear model for the cumulative ongoing pregnancy rate including covariates treatment group, age class (< 32 yrs vs. ≥ 32 yrs), planned IVF treatment (IVF vs. ICSI) and region (Europe vs. Asia).|
1719896|NCT00702507|3166867|Superiority or Other||Percentage of participants|29.2|||||2-Sided|95.0|22.4|36.7|||||Percentage of participants with overall cure at the test-of-cure visit (Day 14) of the initial episode for participants in the MITT Population||
1719897|NCT00702468|3166868|Superiority or Other||Odds Ratio (OR)|3.444||||0.1151|2-Sided|90.0|0.948|13.718|||Regression, Logistic||||
1719905|NCT00702273|3166931|Non-Inferiority or Equivalence|Non-inferiority margin of -8%|Risk Difference (RD)|2.4|||||2-Sided|95.0|-2.6|7.4||||||Treatment groups were compared with a generalized linear model including covariates treatment group, age class and region.|
1719906|NCT00702143|3166941|Superiority or Other|||||||0.0003|||||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR|
1719907|NCT00702143|3166941|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR|
1719908|NCT00702143|3166941|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis of variance contrast P value testing for difference in the mean cortical SUVR|
1719909|NCT00702143|3166941|Superiority or Other||||||<|0.0001|||||||ANOVA|||Analysis of variance P value testing for an overall difference in the mean cortical SUVR between the clinical diagnostic groups.|
1719910|NCT00702143|3166943|Superiority or Other|||||||0.0014|||||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups|
1719911|NCT00702143|3166943|Superiority or Other||||||<|0.0001|||||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups|
1719912|NCT00702143|3166943|Superiority or Other||||||<|0.0002|||||||Fisher Exact|||Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups|
1719913|NCT00701935|3166944|Superiority or Other||Ratio|3.28|Standard Error of the Mean|2.63||0.1388|2-Sided|95.0|0.68|15.77||p-values were not adjusted for multiple comparisons.|Regression, Linear|Generalized linear model was used with the assumption of an underlying Poisson distribution and the logarithm of exposure (years) as offset variable.||Event rate per subject year was calculated for each subject : (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last post-baseline visit date - baseline visit date.|
1719914|NCT00701935|3166945|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.048||0.7915|2-Sided|95.0|-0.08|0.11||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline HDL cholesterol|||
1719915|NCT00701935|3166946|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.279||0.4007|2-Sided|95.0|-0.8|0.33||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline triglycerides|||
1719916|NCT00701935|3166947|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.248||0.4145|2-Sided|95.0|-0.71|0.3||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline total cholesterol|||
1719917|NCT00701935|3166950|Superiority or Other||Mean Difference (Final Values)|-2.21|Standard Error of the Mean|0.725||0.0035|2-Sided|95.0|-3.66|-0.76||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline body weight.|||
1719918|NCT00701935|3166951|Superiority or Other||Mean Difference (Final Values)|-1.39|Standard Error of the Mean|0.491||0.0073|2-Sided|95.0|-2.38|-0.4||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline fasting plasma glucose.|||
1719919|NCT00701935|3166953|Superiority or Other||Mean Difference (Final Values)|-0.88|Standard Error of the Mean|0.155|<|0.0001|2-Sided|95.0|-1.19|-0.57||p-values were not adjusted for multiple comparisons.|ANCOVA|ANCOVA analysis included the following factors: treatment, gender, investigator and baseline HbA1c|||
1719920|NCT00701935|3166954|Superiority or Other||Mean Difference (Final Values)|-3.71|Standard Error of the Mean|2.687||0.1755|2-Sided|95.0|-9.15|1.73||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline subcutaneous abdominal fat.|||
1719921|NCT00701935|3166955|Superiority or Other||Mean Difference (Final Values)|-2.07|Standard Error of the Mean|3.193||0.5207|2-Sided|95.0|-8.53|4.39||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline total abdominal fat.|||
1719922|NCT00701935|3166956|Superiority or Other||Mean Difference (Final Values)|-0.98|Standard Error of the Mean|4.432||0.8252|2-Sided|95.0|-9.92|7.95||p-values were not adjusted for multiple comparisons.|ANCOVA|The ANCOVA model includes terms of treatment, gender, investigator and baseline abdominal visceral fat.||"The power calculation is based on a two-sided t-test and significance level of 0.05.~Hypotheses for sample size:~Power: 80% Drop-out rate: 20% Difference in the percentage change in abdominal visceral fat from baseline to 6 months between exenatide and placebo: 10% Common standard deviation: 15%~94 patients are needed to attain the 37 patients randomized and analyzed in each group."|
1719923|NCT00701727|3166977|Superiority or Other|||||||0.95|||||||t-test, 2 sided||||
1719924|NCT00701727|3166978|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1719925|NCT00701727|3166979|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1719926|NCT00701727|3166980|Superiority or Other|||||||0.12|||||||t-test, 2 sided||||
1719927|NCT00701727|3166981|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1719928|NCT00701727|3166982|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1719929|NCT00701727|3166983|Superiority or Other|||||||0.019|||||||t-test, 2 sided||||
1719930|NCT00701441|3167006|Superiority or Other|||||||0.02||||||We only consider tests in the hypothesized direction conclusive, so testing is conservative from that perspective. However, we used no correction for multiple testing when declaring significance|t-test, 2 sided|||For comparing pre- versus post-treatment, paired t tests were used. For each variable and comparison, we tested at the 0.05 level with double-sided P values.|
1719931|NCT00701441|3167007|Superiority or Other|||||||0.02||||||For comparing pre versus post, paired t tests were used. We considered tests in the hypothesized direction conclusive|t-test, 2 sided|For each comparison, we tested at the 0.05 level with double-sided P values. We used no correction for multiple testing when declaring significance.||Flow mediated dilation = [(average maximum dilation post cuff deflation - average baseline diameter)/ average baseline diameter]100|
1719932|NCT00701389|3167013|Superiority or Other||Difference in Least Squares Means|1.2|||||2-Sided|90.0|-0.2|2.7||||||sumatriptan placebo/600 mg telcagepant minus sumatriptan placebo/telcagepant placebo|
1720023|NCT00699907|3167266|Superiority or Other||||||>|0.037|||||||Wilcoxon Rank Sum Test||||
1719933|NCT00701389|3167014|Non-Inferiority or Equivalence|If the upper bound of the 90% CI is less than 5 mmHg, the primary hypothesis would be supported.|Difference in Least Squares Means|1.5|||||2-Sided|90.0|0.0|3.0||||||100 mg sumatriptan/600 mg telcagepant minus 100 mg sumatriptan/telcagepant placebo|
1719934|NCT00701363|3167023|Superiority or Other|||||||0.0103|||||||t-test, 2 sided|||Difference in baseline IGF-1 levels between 108 subjects with normalized IGF-1 levels at week 24 (A+B+C) and 14 subjects with uncontrolled IGF-1 levels at week 24.|
1719935|NCT00701363|3167024|Superiority or Other|||||||0.017|||||||t-test, 2 sided||||
1719936|NCT00701363|3167024|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1719937|NCT00701363|3167024|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1719938|NCT00701363|3167024|Superiority or Other||||||<|0.0009|||||||t-test, 2 sided||||
1719939|NCT00701363|3167025|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1719940|NCT00701363|3167025|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1719941|NCT00701363|3167025|Superiority or Other||||||<|0.0013|||||||ANCOVA|||One subject (Group B) had missing IGF-1 value at Week 48. One subject (Group A) had missing IGF-1 value at Baseline.|
1719942|NCT00701090|3167048|Superiority or Other||Odds Ratio (OR)|0.67|||||2-Sided|95.0|0.47|0.95|||||The parameter estimate and 95% CI represent the odds of having A1C <6.5% at Week 30 in the Sitagliptin group vs. the Glimepiride group, computed using a logistic regression model controlling for treatment, country and baseline A1C.||
1719943|NCT00701090|3167049|Superiority or Other||Odds Ratio (OR)|0.65|||||2-Sided|95.0|0.47|0.9|||||The parameter estimate and 95% CI represent the odds of having A1C <7.0% at Week 30 in the Sitagliptin group vs. the Glimepiride group, computed using a logistic regression model controlling for treatment, country and baseline A1C.||
1719944|NCT00701090|3167050|Superiority or Other||Mean Difference (Net)|-2.0|Standard Deviation|2.9|<|0.001|2-Sided|95.0|-2.3|-1.6|||ANCOVA|Model terms: treatment, country, and baseline.|ANCOVA model terms: treatment, country, and baseline.||
1719945|NCT00701090|3167051|Superiority or Other||Risk Difference (RD)|-15.0|||<|0.001|2-Sided|95.0|-19.3|-10.9|||Miettinen &Nurminen method||Miettinen &Nurminen method was used for the 95% confidence interval||
1719946|NCT00701090|3167052|Superiority or Other||Mean Difference (Net)|2.9|Standard Deviation|28.8|||2-Sided|95.0|-0.9|6.7|||||ANCOVA model terms: treatment, country, and baseline.||
1719947|NCT00701090|3167053|Non-Inferiority or Equivalence|The pre-specified non-inferiority margin was 0.4%, i.e., Sitagliptin was declared non-inferior to glimepiride if the upper limit of the two-sided 95% confidence interval for the between group difference (sitagliptin minus glimepiride) was less than 0.4%|Mean Difference (Net)|0.07|Standard Deviation|0.7|||2-Sided|95.0|-0.03|0.16|||||ANCOVA model with terms: treatment, country, and baseline HbA1c.||
1719948|NCT00700999|3167067|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Deviation|1.78||0.869|2-Sided|95.0|-0.84|0.99|||t-test, 2 sided||||
1719949|NCT00700999|3167067|Superiority or Other||Mean Difference (Final Values)|-0.92|Standard Deviation|0.9||0.001|2-Sided|95.0|-1.38|-0.45|||t-test, 2 sided||||
1719950|NCT00700817|3167144|Superiority or Other||Change within treatment group|-0.45|Standard Deviation|0.9||0.0001||95.0|-0.67|-0.23||Multiple comparisons is not applicable.|paired t-test|The analysis is not a controlled comparison, and there are no adjustments||The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.|
1719951|NCT00700817|3167144|Superiority or Other||Change within treatment group|-0.24|Standard Deviation|0.7||0.006||95.0|-0.41|-0.07||Multiple comparisons is not applicable.|paired t-test|The analysis is not a controlled comparison, and there are no adjustments||The t-test was performed to examine whether the change in HbA1c from week 52 to week 78 were different from 0 within each treatment group.|
1719952|NCT00700817|3167146|Non-Inferiority or Equivalence|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated Treatment Difference, LS Mean|-0.4||||0.0001||95.0|-0.59|-0.22||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).|Lira 1.2 - Sita|ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.|
1719953|NCT00700817|3167146|Non-Inferiority or Equivalence|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated Treatment Difference, LS Mean|-0.63||||0.0001||95.0|-0.81|-0.44||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).|Lira 1.8 - Sita|ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate.|
1719954|NCT00700817|3167147|Non-Inferiority or Equivalence|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.34||||0.0001||95.0|-0.51|-0.16||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).||ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority. Liraglutide 1.2 mg versus sitagliptin only tested if liraglutide 1.8 mg was superior to sitagliptin.|
1719955|NCT00700817|3167147|Non-Inferiority or Equivalence|Non-inferiority concluded if upper confidence interval of test was below 0.4%. Superiority concluded if upper limit of confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.6||||0.0001||95.0|-0.77|-0.43||Multiple comparisons not applicable due to the hieracheal testing.|ANCOVA|Adjusted for treatment and country (fixed effects) and baseline HbA1c (covariate).||ANCOVA with treatment and country as fixed effects and baseline HbA1c as covariate. Hieracheal testing of non-inferiority followed by superiority.|
1719956|NCT00700804|3167148|Superiority or Other||Mean Difference (Final Values)|9.7|Standard Deviation|2.5||0.05|||||||Mixed Models Analysis|Effects of calcium (Ca), protein & their interaction were tested using repeated measures analysis of variance (subjects nested under High or Low Ca)|Reported analysis is the main effect of Calcium (High vs Low) from the Mixed Model Analysis which averages across the two levels of dietary protein. The main effect of protein and the calcium x protein interaction were not statistically significant.||
1720024|NCT00699907|3167267|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test||||
1720025|NCT00699907|3167267|Superiority or Other||||||>|0.009|||||||Wilcoxon Rank Sum Test||||
1719957|NCT00700752|3167150|Superiority or Other||Mean Difference (Final Values)|1.1636|Standard Error of the Mean|0.1887|||2-Sided|95.0|0.789|1.1636|||||The mean difference is calculated as senofilcon A minus balafilcon A.|Alternative hypothesis is senofilcon A is superior to balafilcon A for comfort.|
1719958|NCT00700622|3167175|Non-Inferiority or Equivalence|A sample size of 92 subjects in each group was required to complete the trial. Approximately 230 subjects were to be randomized to achieve 184 completers (assuming a 20% dropout rate). This would have provided 80% power for a noninferiority design to test the difference of a 4-month change in HbA1c levels between treatment groups, assuming the upper noninferiority margins Δ of 0.5% with a standard deviation of 1.2 and a 1-sided alpha of 0.025.|Mean Difference (Net)|-0.07|Standard Error of the Mean|0.119|||2-Sided|95.0|-0.31|0.17|||||||
1719959|NCT00700570|3167176|Superiority or Other|||||||0.001|||||||Fisher Exact||||
1719960|NCT00700570|3167178|Superiority or Other|||||||0.1341|||||||Log Rank||||
1719961|NCT00700427|3167184|Superiority or Other|||||||0.006|||||||ANCOVA||||
1719962|NCT00700427|3167185|Superiority or Other|||||||0.006|||||||ANCOVA||||
1719963|NCT00700427|3167186|Superiority or Other||||||<|0.001||||||P-value for Total ADHD Symptom Imputed Score.|ANCOVA||||
1719964|NCT00700427|3167186|Superiority or Other||||||<|0.001||||||P-value for Inattention Subscale Imputed Score.|ANCOVA||||
1719965|NCT00700427|3167186|Superiority or Other||||||<|0.001||||||P-value for Hyperactivity/Impulsivity Subscale Imputed Score.|ANCOVA||||
1719966|NCT00700427|3167186|Superiority or Other||||||<|0.001||||||P-value for ADHD Imputed (Attributed) Index Score.|ANCOVA||||
1719967|NCT00700427|3167187|Superiority or Other|||||||0.003||||||P-value for Total ADHD Symptom Imputed Score.|ANCOVA||||
1719968|NCT00700427|3167187|Superiority or Other|||||||0.009||||||P-value for Inattention Subscale Imputed Score.|ANCOVA||||
1719969|NCT00700427|3167187|Superiority or Other|||||||0.002||||||P-value for Hyperactivity/Impulsivity Subscale Imputed Score.|ANCOVA||||
1719970|NCT00700427|3167187|Superiority or Other||||||<|0.001||||||P-value for ADHD Imputed (Attributed) Index Score.|ANCOVA||||
1719971|NCT00700427|3167188|Superiority or Other|||||||0.002|||||||ANCOVA||||
1719972|NCT00700427|3167190|Superiority or Other|||||||0.001|||||||Fisher Exact||||
1719973|NCT00700180|3167214|Superiority or Other||Hazard Ratio (HR)|1.16||||0.312|2-Sided|95.0|0.87|1.53|||Log Rank||||
1719974|NCT00700180|3167216|Superiority or Other||Hazard Ratio (HR)|1.07||||0.7587|2-Sided|95.0|0.68|1.69|||Log Rank||||
1719975|NCT00700180|3167218|Superiority or Other||Mean Difference (Final Values)|1.75||||0.6148|2-Sided|95.0|-8.2|11.7|||Cochran-Mantel-Haenszel||Approximate 95% CI for difference of two rates using Hauck-Anderson method||
1719976|NCT00700180|3167219|Superiority or Other||Difference in Responses Rates|9.34||||0.1737|2-Sided|95.0|-2.4|21.0|||Cochran-Mantel-Haenszel||Approximate 95% Confidence Interval (CI) for difference of two rates using Hauck-Anderson method.||
1719977|NCT00700180|3167220|Superiority or Other||Hazard Ratio (HR)|1.01||||0.9454|2-Sided|95.0|0.78|1.31|||Log Rank||||
1719978|NCT00700180|3167222|Superiority or Other||Odds Ratio (OR)|1.44||||0.1758|2-Sided|95.0|0.85|2.45||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGFR-2 (high versus low)|
1719979|NCT00700180|3167222|Superiority or Other||Odds Ratio (OR)|0.77||||0.3193|2-Sided|95.0|0.46|1.29||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGFR-1 (high versus low)|
1719980|NCT00700180|3167222|Superiority or Other||Odds Ratio (OR)|1.22||||0.4601|2-Sided|95.0|0.72|2.09||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||VEGF A (high versus low)|
1719981|NCT00700180|3167222|Superiority or Other||Odds Ratio (OR)|1.16||||0.6761|2-Sided|95.0|0.58|2.33||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||PlGF (high versus low)|
1719982|NCT00700180|3167222|Superiority or Other||Odds Ratio (OR)|1.09||||0.7478|2-Sided|95.0|0.64|1.85||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||ICAM (high versus low)|
1719983|NCT00700180|3167222|Superiority or Other||Odds Ratio (OR)|1.81||||0.0285|2-Sided|95.0|1.06|3.08||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||E-selectin (high versus low)|
1719984|NCT00700180|3167222|Superiority or Other||Odds Ratio (OR)|1.07||||0.8127|2-Sided|95.0|0.63|1.8||Multiple logistic regression model with treatment, biomarker level (dichotomized) and baseline prognostic factors as covariates.|Regression, Logistic|||bFGF (high versus low)|
1719985|NCT00700102|3167228|Superiority or Other|||||||0.4315|||||||Cochran-Mantel-Haenszel||||
1719986|NCT00700102|3167228|Superiority or Other||Mean Difference (Final Values)|1.5||||0.3113|2-Sided|95.0|-1.5|4.5|||Chi-squared||||
1719987|NCT00700102|3167229|Superiority or Other||Hazard Ratio (HR)|0.68|||<|0.0001|2-Sided|95.0|0.59|0.78|||Log Rank||||
1719988|NCT00700102|3167231|Superiority or Other||Hazard Ratio (HR)|0.9||||0.1713|2-Sided|95.0|0.77|1.05|||Log Rank|||Kaplan Meier Estimate|
1719989|NCT00700102|3167232|Superiority or Other||Hazard Ratio (HR)|0.81||||0.0062|2-Sided|95.0|0.69|0.94|||Log Rank||||
1719990|NCT00699998|3167250|Superiority or Other|||||||0.53||||||p-value is for the comparison of angina frequency at at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA||||
1719991|NCT00699998|3167250|Superiority or Other|||||||0.63||||||p-value is for the comparison of physical limitations at 24 months. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA||||
1719992|NCT00699998|3167250|Superiority or Other|||||||0.72||||||p-value is for the comparison of angina frequency at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA||||
1720026|NCT00699907|3167268|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test||||
1719993|NCT00699998|3167250|Superiority or Other|||||||0.5||||||p-value is for the comparison of physical limitations at baseline. p-values are from a regression model with treatment group and the respective baseline quality-of-life measure as predictors.|ANCOVA||||
1719994|NCT00699998|3167252|Superiority or Other||Geometric Ratio Estimate|1.033||||0.802|2-Sided|95.0|0.803|1.329||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.||
1719995|NCT00699998|3167252|Superiority or Other||Geometric Ratio Estimate|1.096||||0.458|2-Sided|95.0|0.859|1.399||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.||
1719996|NCT00699998|3167252|Superiority or Other||Geometric Ratio Estimate|1.057||||0.346|2-Sided|95.0|0.942|1.187||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.||
1719997|NCT00699998|3167252|Superiority or Other||Geometric Ratio Estimate|1.018||||0.727|2-Sided|95.0|0.919|1.129||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.||
1719998|NCT00699998|3167253|Superiority or Other||Geometric Ratio Estimate|1.066||||0.545|2-Sided|95.0|0.867|1.31||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.||
1719999|NCT00699998|3167253|Superiority or Other||Geometric Ratio Estimate|1.138||||0.098|2-Sided|95.0|0.977|1.325||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.||
1720000|NCT00699998|3167253|Superiority or Other||Geometric Ratio Estimate|1.01||||0.844|2-Sided|95.0|0.916|1.113||p-value is for the 6 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 6 month comparison.||
1720001|NCT00699998|3167253|Superiority or Other||Geometric Ratio Estimate|0.982||||0.631|2-Sided|95.0|0.91|1.059||p-value is for the 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Geometric Ratio Estimate is for the 30 day comparison.||
1720002|NCT00699998|3167254|Superiority or Other||Mean Difference (Final Values)|-46.264|||<|0.001|2-Sided|95.0|-69.061|-23.468||p-value is for the 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) is for the 12 month comparison.||
1720003|NCT00699998|3167254|Superiority or Other||Mean Difference (Final Values)|-48.413|||<|0.001|2-Sided|95.0|-63.718|-33.108||p-value is for 30 day comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) is for the 30 day comparison.||
1720004|NCT00699998|3167254|Superiority or Other||Mean Difference (Final Values)|-104.475|||<|0.001|2-Sided|95.0|-115.383|-93.566||p-value is for 12 month comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) for 12 month comparison.||
1720005|NCT00699998|3167254|Superiority or Other||Mean Difference (Final Values)|-100.208|||<|0.001|2-Sided|95.0|-107.872|-92.545||p-value is for Day 30 comparison. ANCOVA Model: Measurement = treatment + baseline value + clopidogrel status at randomization.|ANCOVA||Estimated Mean Difference (Final Values) for Day 30 comparison||
1720006|NCT00699998|3167255|Superiority or Other||Hazard Ratio (HR)|1.017||||0.831|2-Sided|95.0|0.862|1.2||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.||
1720007|NCT00699998|3167255|Superiority or Other||Hazard Ratio (HR)|0.928||||0.27|2-Sided|95.0|0.81|1.063||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.||
1720008|NCT00699998|3167256|Superiority or Other||Hazard Ratio (HR)|1.029||||0.719|2-Sided|95.0|0.869|1.218||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.||
1720009|NCT00699998|3167256|Superiority or Other||Hazard Ratio (HR)|0.941||||0.353|2-Sided|95.0|0.826|1.073||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.||
1720010|NCT00699998|3167257|Superiority or Other||Hazard Ratio (HR)|0.998||||0.99|2-Sided|95.0|0.833|1.195||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.||
1720011|NCT00699998|3167257|Superiority or Other||Hazard Ratio (HR)|0.94||||0.388|2-Sided|95.0|0.812|1.088|||Log Rank|Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.||
1720012|NCT00699998|3167258|Superiority or Other||Hazard Ratio (HR)|1.029||||0.731|2-Sided|95.0|0.865|1.225||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.||
1720013|NCT00699998|3167258|Superiority or Other||Hazard Ratio (HR)|0.915||||0.21|2-Sided|95.0|0.793|1.055||Two-sided p-value based on a log-rank test stratified by clopidogrel status at randomization.|Log Rank||HR and two-sided 95% CI derived using Cox proportional hazards model with treatment and clopidogrel status at randomization as fixed effects.||
1720014|NCT00699907|3167262|Superiority or Other|||||||0.005|||||||Wilcoxon Rank Sum Test||||
1720015|NCT00699907|3167262|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum Test||||
1720028|NCT00699907|3167269|Superiority or Other|||||||0.005|||||||Wilcoxon Rank Sum Test||||
1720029|NCT00699907|3167269|Superiority or Other|||||||0.01|||||||Wilcoxon Rank Sum Test||||
1720030|NCT00699907|3167270|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test||||
1720031|NCT00699907|3167270|Superiority or Other||||||>|0.012|||||||Wilcoxon Rank Sum Test||||
1720032|NCT00699816|3167276|Superiority or Other||Hazard Ratio (HR)|0.19||||0.02|2-Sided|95.0|0.04|0.87|||Log Rank||||
1720033|NCT00699816|3167277|Superiority or Other||Hazard Ratio (HR)|0.21||||0.008|2-Sided|95.0|0.06|0.75|||Log Rank||||
1720034|NCT00699816|3167278|Superiority or Other||Hazard Ratio (HR)|0.63||||0.01|2-Sided|95.0|0.43|0.94|||Log Rank||||
1720035|NCT00699751|3167295|Superiority or Other||Hazard Ratio (HR)|0.69||||0.00187|2-Sided|95.0|0.546|0.873||Time to Marked Deterioration of ECOG PS|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Marked Deterioration of ECOG PS, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720036|NCT00699751|3167296|Superiority or Other||Hazard Ratio (HR)|0.727||||0.00932|2-Sided|95.0|0.571|0.925||Time to Other Cancer Treatment|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Other Cancer Treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720037|NCT00699751|3167297|Superiority or Other||Hazard Ratio (HR)|0.68||||0.14486|2-Sided|95.0|0.404|1.145||Time to Spinal Cord Compression|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Spinal Cord Compression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720038|NCT00699751|3167298|Superiority or Other||Hazard Ratio (HR)|0.949||||0.89567|2-Sided|95.0|0.435|2.07||Time to Surgical Intervention|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Surgical Intervention, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists|
1720039|NCT00699751|3167299|Superiority or Other||Hazard Ratio (HR)|0.847||||0.53277|2-Sided|95.0|0.504|1.426||Time to Pathological Bone Fracture|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Pathological Bone Fracture, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists|
1720040|NCT00699751|3167300|Superiority or Other||Hazard Ratio (HR)|0.344||||0.00191|2-Sided|95.0|0.17|0.695||stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to Receiving Radio-isotope, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists|
1720041|NCT00699751|3167301|Superiority or Other||Hazard Ratio (HR)|0.639||||8e-05|2-Sided|95.0|0.511|0.8||Time to External Beam Radiotherapy|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to EBRT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists|
1720042|NCT00699751|3167302|Superiority or Other||Hazard Ratio (HR)|0.657||||0.00012|2-Sided|95.0|0.529|0.814||Time to first Skeletal Related Event (SRE)|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to first SRE, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists|
1720043|NCT00699751|3167303|Superiority or Other||||||<|0.001||||||Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720044|NCT00699751|3167304|Superiority or Other|||||||0.009||||||Percentage change from baseline in PSA at EOT|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline in PSA at EOT, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720045|NCT00699751|3167305|Superiority or Other|||||||0.004||||||Maximum Percentage Decrease from Baseline up to Week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage Decrease from Baseline up to Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720303|NCT00696410|3167833|Superiority or Other|||||||0.33|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)|
1720046|NCT00699751|3167306|Superiority or Other|||||||0.16||||||Percentage change from baseline in PSA at Week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline in PSA at Week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720047|NCT00699751|3167307|Superiority or Other|||||||0.005||||||Confirmed PSA Response(>=50%)|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed PSA Response(>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720048|NCT00699751|3167307|Superiority or Other|||||||0.002||||||>=50% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of >=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720049|NCT00699751|3167307|Superiority or Other||||||<|0.001||||||>=30% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of >=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720050|NCT00699751|3167308|Superiority or Other|||||||0.032||||||Confirmed PSA Response(>=50%)|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed PSA Response(>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720051|NCT00699751|3167308|Superiority or Other|||||||0.106||||||>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of >=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720052|NCT00699751|3167308|Superiority or Other||||||<|0.001||||||>=30% reduction in blood level|Cochran-Mantel-Haenszel|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of >=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720053|NCT00699751|3167309|Superiority or Other||Hazard Ratio (HR)|0.643|||<|1e-05|2-Sided|95.0|0.539|0.768||Time to Prostate Specific Antigen (PSA) progression|Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of Time to PSA progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720054|NCT00699751|3167310|Superiority or Other||||||<|0.001||||||Maximum Percentage decrease from baseline during the 24 week treatment|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage decrease from baseline during the 24 week treatment, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720055|NCT00699751|3167311|Superiority or Other||||||<|0.001||||||Percentage change from baseline|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720056|NCT00699751|3167312|Superiority or Other||||||<|0.001||||||Maximum Percentage decrease from baseline to week 12|ANCOVA|Adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Maximum Percentage decrease from baseline to week 12, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720057|NCT00699751|3167313|Superiority or Other||||||<|0.001||||||Percentage Change from Baseline|ANCOVA|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Percentage change from baseline, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720058|NCT00699751|3167314|Superiority or Other||||||<|0.001||||||Total ALP normalization|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Total ALP normalization, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720059|NCT00699751|3167315|Superiority or Other||||||<|0.001||||||Confirmed Total ALP Response (>=50%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720060|NCT00699751|3167315|Superiority or Other||||||<|0.001||||||>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of >=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720061|NCT00699751|3167315|Superiority or Other||||||<|0.001||||||>=30% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of >=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720062|NCT00699751|3167316|Superiority or Other||||||<|0.001||||||Confirmed Total ALP Response (>=50%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (>=50%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720063|NCT00699751|3167316|Superiority or Other||||||<|0.001||||||Confirmed Total ALP Response (>=30%)|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of Confirmed Total ALP Response (>=30%), is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720064|NCT00699751|3167316|Superiority or Other||||||<|0.001||||||>=50% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of >=50% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720065|NCT00699751|3167316|Superiority or Other||||||<|0.001||||||>=30% reduction in blood level|Cochran-Mantel-Haenszel|adjusting for the binary stratification factors, total ALP, current use of Bisphosphonates and prior use of Docetaxel.||The null hypothesis for the comparison of >=30% reduction in blood level, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720066|NCT00699751|3167317|Superiority or Other||Hazard Ratio (HR)|0.169|||<|1e-05|2-Sided|95.0|0.131|0.22|||Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of time to total ALP progression, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720067|NCT00699751|3167318|Superiority or Other||Hazard Ratio (HR)|0.691||||5e-05|2-Sided|95.0|0.578|0.827|||Log Rank|Stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The hazard ratio (Alpharadin:Placebo) is from a Cox proportional hazards model stratified by total ALP, current use of bisphosphonates and prior use of Docetaxel.|The null hypothesis for the comparison of overall survival, and also for the secondary endpoints, is that there is no difference between Alpharadin and placebo for that endpoint; the alternative hypothesis is that a difference exists.|
1720068|NCT00699660|3167323|Superiority or Other||Slope|47.3|Standard Error of the Mean|18.86||0.012|2-Sided|||||0.05 level based on a two tailed test.|Regression, Linear|Covariates included years of experience, use of template, use of tests, age, education, study site.||Estimates of the influence on total time and tests of statistical significance were derived from multilevel mixed-effects linear regression (xtmixed in Stata)|
1720069|NCT00699660|3167324|Superiority or Other||||||>|0.05||||||Descriptive statistics on mean and standard deviation.|t-test, 2 sided||||
1720070|NCT00699660|3167325|Superiority or Other||||||<|0.01|||||||Regression, Logistic||||
1720071|NCT00699660|3167326|Superiority or Other||||||<|0.001||||||Comparison of CAPS/WHODAS vs Nonstructured Interview study arms: linear and logistic mixed effects regression with clinical examiner stratified by study group as a random effect and study group as a fixed effect.|Regression, Linear|Covariates included experience, use of template,tests,reviewing records,age,education, study site,reviewer, and expert reviewer by group interaction.||Our sample size calculation yielded 466 for a power of 0.80 to detect a 10% absolute difference in sensitivity and adjusted for intraclass correlation. The number of covariates in regression models was limited to ensure the effective sample size remained ten times greater than the degrees of freedom in the model.|
1720072|NCT00699608|3167341|Superiority or Other||Mean Difference (Final Values)|-0.99||||0.267||95.0|-2.74|0.76|||ANCOVA|ANCOVA used (fixed effects: adjusted period baseline, participant baseline, age, gender, period and treatment group; random effect: participant).|||
1720073|NCT00699374|3167368|Superiority or Other||Hazard Ratio (HR)|1.13||||0.8459|2-Sided|95.0|0.98|1.31||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE and tumor invasion condition|Log Rank||||
1720074|NCT00699374|3167369|Superiority or Other||Hazard Ratio (HR)|1.13||||0.8857|2-Sided|95.0|0.99|1.3||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior TACE, and tumor invasion condition|Log Rank||||
1720075|NCT00699374|3167370|Superiority or Other||Hazard Ratio (HR)|1.31||||0.9993|2-Sided|95.0|1.14|1.5||One-sided p-value based on stratified log-rank test controlling the effects of geographic region, prior transarterial chemoembolization (TACE) and tumor invasion condition.|Log Rank||||
1720076|NCT00698997|3167420|Other|Non- equivalence.|slope difference|1.01||||0.03|2-Sided||||||Mixed Models Analysis|||We used a generalized linear mixed model (GLMM). Change-over-Time was modeled as a linear within-subject effect of time across all observed data for each participant. We fit splines to manage the differing lengths of time in parent-training versus direct treatment. In all analyses, site was included as a categorical covariate to account for potential differences. Effect sizes were reported following Cohen’s recommendations as f2.|
1720077|NCT00698932|3167421|Superiority or Other||Median Difference (Net)|17.0|||<|0.0001||95.0|8.9|24.9|||ANCOVA||||
1720078|NCT00698932|3167422|Superiority or Other||Mean Difference (Net)|-3280.0|Standard Error of the Mean|980.0||0.001||95.0|-5214.0|-1345.0|||ANCOVA|*adjusted for baseline PPG AUC|||
1720079|NCT00698932|3167423|Superiority or Other||Median Difference (Net)|-182.0|Standard Error of the Mean|54.4||0.001||95.0|-289.0|-74.0|||ANCOVA|*adjusted for baseline PPG AUC|||
1720080|NCT00698932|3167424|Superiority or Other||Mean Difference (Net)|-13.12|Standard Error of the Mean|3.053|<|0.0001||95.0|-19.12|-7.13|||ANCOVA|*adjusted for baseline FPG|||
1720081|NCT00698932|3167425|Superiority or Other||Mean Difference (Net)|-0.73|Standard Error of the Mean|0.17|<|0.0001||95.0|-1.06|-0.39|||ANCOVA|*adjusted for baseline FPG|||
1720082|NCT00698932|3167426|Superiority or Other||Mean Difference (Net)|-0.5|Standard Error of the Mean|0.079|<|0.0001||95.0|-0.65|-0.34|||ANCOVA|*adjusted for baseline HbA1c|||
1720083|NCT00698685|3167447|Superiority or Other||actuarial probability of engraftment|70.0||||||95.0|||||||Actuarial probability of engraftment at day +100 is calculated according to the product-limit estimate method.||
1720084|NCT00698516|3167464|Superiority or Other||Greenwood variance|65.0|Standard Error of the Mean|7.07||0.017|2-Sided|95.0|49.3|76.9||Historical data in target population showed 3-month PFS rates of <=50%. Oral topotecan with IV bevacizumab would provide clinically meaningful improvement in 3-month PFS if it could demonstrate a 40% improvement relative to the historical data.|Z statistic|Z statistic was used to reject the null hypothesis provided Z>=1.65, where Z = (KM estimate at 3 months – null hypothesis value [50%])/Greenwood SE.|||
1720085|NCT00698451|3167466|Superiority or Other||Percentage|72.2||||0.05|2-Sided|95.0|58.4|83.5|||Exact Binomial Distribution||||
1720086|NCT00698035|3167472|Superiority or Other|||||||0.0061||||||Significant at p<0.05|t-test, 2 sided|||Difference in petechiae between baseline and week 12|
1720087|NCT00698035|3167472|Superiority or Other||||||<|0.001||||||Significant at p<0.05|t-test, 2 sided|||Differences in rugae, pallor, mucosal thinning, and dryness from baseline to 12 weeks|
1720088|NCT00698035|3167472|Superiority or Other||||||<|0.001||||||Significant at p<0.05|t-test, 2 sided|||Differences in rugae, pallor, petechiae, mucosal thinning and dryness between baseline and week 12|
1720089|NCT00698035|3167473|Superiority or Other|||||||0.139||||||Significant at p<0.05|t-test, 2 sided|||Change in SS from Baseline to Week 12|
1720090|NCT00698035|3167473|Superiority or Other|||||||0.004||||||Significant at p<0.05|t-test, 2 sided|||Change in SS from Baseline to Week 12|
1720091|NCT00698035|3167474|Superiority or Other||||||<|0.001||||||Significant at p<0.05|t-test, 2 sided|||Change in SD from BL to W12|
1720092|NCT00698035|3167474|Superiority or Other||||||<|0.0228||||||Significant at p<0.05|t-test, 2 sided|||Change in SI from BL to W12|
1720093|NCT00698035|3167474|Superiority or Other||||||<|0.001||||||Significant at p<0.05|t-test, 2 sided|||Change in SD from BL to W12|
1720094|NCT00698035|3167474|Superiority or Other||||||<|0.021||||||Significant at p<0.05|t-test, 2 sided|||Change in SI from BL to W12|
1720095|NCT00698035|3167477|Superiority or Other||||||>|0.05||||||singificant at p<0.05|t-test, 2 sided|||Comparison of week 4 estradiol between LC/MS and RIA|
1720096|NCT00698035|3167477|Superiority or Other||||||>|0.05||||||Significant at p<0.05|t-test, 2 sided|||Comparison of baseline estradiol between LC/MS and RIA|
1720097|NCT00697619|3167495|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1720098|NCT00697619|3167495|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1720099|NCT00697619|3167495|Superiority or Other||||||<|0.37|||||||Wilcoxon (Mann-Whitney)||||
1720100|NCT00697515|3167532|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1720101|NCT00697515|3167533|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1720102|NCT00697515|3167535|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1720103|NCT00697515|3167536|Superiority or Other||||||<|0.0001|||||||Prescott's Test||||
1720104|NCT00697515|3167539|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1720105|NCT00697515|3167540|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1720106|NCT00697515|3167541|Superiority or Other||||||<|0.0001|||||||ANOVA|||14.0 hours post-dose|
1720107|NCT00697515|3167541|Superiority or Other||||||<|0.0001|||||||ANOVA|||12.0 hours post-dose|
1720108|NCT00697515|3167541|Superiority or Other||||||<|0.0001|||||||ANOVA|||10.0 hours post-dose|
1720109|NCT00697515|3167541|Superiority or Other||||||<|0.0001|||||||ANOVA|||8.0 hours post-dose|
1720110|NCT00697515|3167541|Superiority or Other||||||<|0.0001|||||||ANOVA|||4.0 hours post-dose|
1720111|NCT00697515|3167541|Superiority or Other||||||<|0.0031|||||||ANOVA|||2.0 hours post-dose|
1720112|NCT00697515|3167541|Superiority or Other||||||<|0.0001|||||||ANOVA|||Over the treatment day|
1720113|NCT00697515|3167542|Superiority or Other||||||<|0.0001|||||||ANOVA|||14.0 hours post-dose|
1720114|NCT00697515|3167542|Superiority or Other||||||<|0.0001|||||||ANOVA|||12.0 hours post-dose|
1720115|NCT00697515|3167542|Superiority or Other||||||<|0.0001|||||||ANOVA|||10.0 hours post-dose|
1720116|NCT00697515|3167542|Superiority or Other||||||<|0.0001|||||||ANOVA|||8.0 hours post-dose|
1720117|NCT00697515|3167542|Superiority or Other||||||<|0.0001|||||||ANOVA|||4.0 hours post-dose|
1720118|NCT00697515|3167542|Superiority or Other||||||<|0.001|||||||ANOVA|||2.0 hours post-dose|
1720119|NCT00697515|3167542|Superiority or Other||||||<|0.0001|||||||ANOVA|||Average over the treatment day|
1720120|NCT00697515|3167543|Superiority or Other||||||<|0.0001|||||||ANOVA|||14.0 hours post-dose|
1720121|NCT00697515|3167543|Superiority or Other||||||<|0.0001|||||||ANOVA|||12.0 hours post-dose|
1720122|NCT00697515|3167543|Superiority or Other||||||<|0.0001|||||||ANOVA|||10.0 hours post-dose|
1720123|NCT00697515|3167543|Superiority or Other||||||<|0.0001|||||||ANOVA|||8.0 hours post-dose|
1720124|NCT00697515|3167543|Superiority or Other||||||<|0.0001|||||||ANOVA|||4.0 hours post-dose|
1720125|NCT00697515|3167543|Superiority or Other||||||<|0.0017|||||||ANOVA|||2.0 hours post-dose|
1720126|NCT00697515|3167544|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1720127|NCT00697190|3167599|Non-Inferiority or Equivalence|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.06|||2-Sided|97.5|-0.2|0.02|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.|
1720128|NCT00697190|3167600|Non-Inferiority or Equivalence|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.07|||2-Sided|97.5|-0.23|0.05|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.|
1720129|NCT00697190|3167601|Non-Inferiority or Equivalence|Non-inferiority margin = 0.33|Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.07|||2-Sided|97.5|-0.12|0.14|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in papillary conjunctivitis.|
1720250|NCT00696436|3167809|Superiority or Other||Mean Difference (Final Values)|0.17||||0.821|2-Sided|95.0|-1.3|1.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720130|NCT00697190|3167602|Non-Inferiority or Equivalence|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.34|Standard Error of the Mean|0.1|||2-Sided|97.5|-0.54|-0.15|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.|
1720131|NCT00697190|3167603|Non-Inferiority or Equivalence|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.07|||2-Sided|97.5|-0.34|-0.08|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.|
1720132|NCT00697190|3167604|Non-Inferiority or Equivalence|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.13|||2-Sided|97.5|-0.27|0.26|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival staining.|
1720133|NCT00697190|3167605|Non-Inferiority or Equivalence|Non-inferior margin = 0.33|Median Difference (Final Values)|0.17|Standard Error of the Mean|0.08||||97.5|0.02|0.33|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.|
1720134|NCT00697190|3167606|Non-Inferiority or Equivalence|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.08|||2-Sided|97.5|-0.26|0.08|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.|
1720135|NCT00697190|3167607|Non-Inferiority or Equivalence|Non-inferiority margin = 0.33|Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.07|||2-Sided|97.5|0.04|0.32|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in corneal staining.|
1720136|NCT00697190|3167608|Non-Inferiority or Equivalence|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.1|||2-Sided|97.5|-0.25|0.14|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.|
1720137|NCT00697190|3167609|Non-Inferiority or Equivalence|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.06|||2-Sided|97.5|-0.16|0.07|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.|
1720138|NCT00697190|3167610|Non-Inferiority or Equivalence|Non-inferior margin = 0.33|Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.08|||2-Sided|97.5|-0.25|0.04|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in limbal hyperemia.|
1720139|NCT00697190|3167611|Non-Inferiority or Equivalence|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.08|||2-Sided|97.5|-0.23|0.1|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.|
1720140|NCT00697190|3167612|Non-Inferiority or Equivalence|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.04|||2-Sided|97.5|-0.1|0.06|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.|
1720141|NCT00697190|3167613|Non-Inferiority or Equivalence|Non-inferiority margin = 0.33|Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.09|||2-Sided|97.5|-0.29|0.04|||||The mean difference is calculated as senofilcon A toric minus galyfilcon A toric.|Alternative hypothesis is that senoflicon A toric is non-inferior to galyfilcon A toric in conjunctival hyperemia.|
1720142|NCT00696878|3167706|Superiority or Other||Percentage with immunogenicity|0.0|||||1-Sided|95.0||1.5|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 3|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.|
1720143|NCT00696878|3167706|Superiority or Other||Percentage with immunogenicity|0.0|||||1-Sided|95.0||0.8|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 2|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.|
1720144|NCT00696878|3167706|Superiority or Other||Percentage with immunogenicity|0.0|||||1-Sided|95.0||0.4|||||Provided limit is upper 1-sided 95% confidence limit for study population for percentage of participants with clinically relevant immunogenicity, after Cycle 1|During sample size determination, the upper limit of the one-sided 95% confidence interval for the population incidence of immunogenicity, if no immunogenicity is observed, was calculated. If no immunogenicity is observed in the projected 150 participants who receive corifollitropin alfa during 3 COS cycles, then the upper limit for the population is 2%. For the projected 300 participants who receive corifollitropin alfa during 2 COS cycles, the upper limit for the population is 1%.|
1720145|NCT00696800|3167728|Non-Inferiority or Equivalence|Equivalence margins of -3 and +5 were applied for the difference in number of oocytes. If the 95% confidence interval of the difference exceeded -3 or +5 oocytes, then Corifollitropin Alfa treatment was not considered equivalent to the reference treatment (recFSH).|Mean Difference (Final Values)|1.2||||0.001|2-Sided|95.0|0.5|1.9||Treatment groups were formally compared including covariates treatment group, age and center.|ANOVA||||
1720251|NCT00696436|3167809|Superiority or Other||Mean Difference (Final Values)|-2.28||||0.003|2-Sided|95.0|-3.8|-0.76||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720146|NCT00696800|3167729|Non-Inferiority or Equivalence|Treatment groups were formally compared with a generalized linear model for the ongoing pregnancy rate which included factors for treatment group, age at randomization, and region. A pre-defined non-inferiority margin of 8% was applied.|Risk Difference (RD)|1.1|||||2-Sided|95.0|-3.8|5.9|||||||
1720147|NCT00696787|3167730|Superiority or Other||Adjusted mean|-0.55||||0.317|2-Sided|95.0|-1.64|0.54|||ANCOVA||||
1720148|NCT00696787|3167730|Superiority or Other||Adjusted mean|-0.35||||0.51|2-Sided|95.0|-1.42|0.71|||ANCOVA||||
1720149|NCT00696787|3167731|Superiority or Other||Adjusted mean|-0.28||||0.604|2-Sided|95.0|-1.33|0.77|||ANCOVA||||
1720150|NCT00696787|3167731|Superiority or Other||Adjusted mean|-0.38||||0.471|2-Sided|95.0|-1.42|0.66|||ANCOVA||||
1720151|NCT00696774|3167732|Superiority or Other||Mean Difference (Final Values)|-4.59|||||2-Sided|95.0|-6.65|-2.54|||||Least Squares Mean Difference = Responders - Non-Responders.|Week 8|
1720152|NCT00696774|3167732|Superiority or Other||Mean Difference (Final Values)|-5.88|||||2-Sided|95.0|-7.75|-4.02|||||Least Squares Mean Difference = Responders - Non-Responders.|Week 4|
1720153|NCT00696774|3167733|Superiority or Other||Mean Difference (Final Values)|10.48|||||2-Sided|95.0|4.72|16.24|||||Least Squares Mean Difference = Responders - Non-Responders.|Week 8|
1720154|NCT00696774|3167733|Superiority or Other||Mean Difference (Final Values)|15.05|||||2-Sided|95.0|10.63|19.47|||||Least Squares Mean Difference = Responders - Non-Responders.|Week 4|
1720155|NCT00696774|3167734|Superiority or Other||Mean Difference (Final Values)|1.36|||||2-Sided|95.0|-0.69|3.42|||||Least Squares Mean Difference = Responders - Non-Responders.|Week 8|
1720156|NCT00696774|3167734|Superiority or Other||Mean Difference (Final Values)|0.81|||||2-Sided|95.0|-0.99|2.6|||||Least Squares Mean Difference = Responders - Non-Responders.|Week 4|
1720157|NCT00696774|3167735|Superiority or Other||Mean Difference (Final Values)|-0.49|||||2-Sided|95.0|-0.81|-0.18|||||Least Squares Mean Difference = Responders - Non-Responders.||
1720158|NCT00696774|3167736|Superiority or Other||Mean Difference (Final Values)|-0.42|||||2-Sided|95.0|-1.08|-0.24|||||Least Squares Mean Difference = Responders - Non-Responders.||
1720159|NCT00696774|3167737|Superiority or Other||Mean Difference (Final Values)|-1.13|||||2-Sided|95.0|-1.42|-0.84|||||Least Squares Mean Difference = Responders - Non-Responders.||
1720160|NCT00696774|3167738|Superiority or Other||Mean Difference (Final Values)|-4.42|||||2-Sided|95.0|-6.04|-2.8|||||Least Squares Mean Difference = Responders - Non-Responders.||
1720161|NCT00696774|3167739|Superiority or Other||Mean Difference (Final Values)|-0.97|||||2-Sided|95.0|-1.31|-0.63|||||Least Squares Mean Difference = Responders - Non-Responders.||
1720162|NCT00696774|3167740|Superiority or Other||Mean Difference (Final Values)|-1.88|||||2-Sided|95.0|-2.45|-1.3|||||Least Squares Mean Difference = Responders - Non-Responders.||
1720163|NCT00696774|3167741|Superiority or Other||Mean Difference (Final Values)|-2.22|||||2-Sided|95.0|-2.89|-1.54|||||Least Squares Mean Difference = Responders - Non-Responders.||
1720164|NCT00696774|3167742|Superiority or Other||Mean Difference (Final Values)|-3.29|||||2-Sided|95.0|-4.1|-2.48|||||Least Squares Mean Difference = Responders - Non-Responders.||
1720165|NCT00696774|3167743|Superiority or Other||Mean Difference (Final Values)|-2.47|||||2-Sided|95.0|-3.13|-1.81|||||Least Squares Mean Difference = Responders - Non-Responders.||
1720166|NCT00696774|3167744|Superiority or Other||Mean Difference (Final Values)|-5.85|||||2-Sided|95.0|-7.34|-4.36|||||Least Squares Mean Difference = Responders - Non-Responders.||
1720167|NCT00696774|3167746|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.005|2-Sided|95.0|-1.12|-0.2|||Adjusted Repeated Measures Analysis|Model terms: baseline score & CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit & response-by-visit|Least Squares Mean Difference = Responders - Non-Responders.||
1720168|NCT00696761|3167747|Superiority or Other||||||<|0.05|||||||Kruskal-Wallis|||The Kruskal-Wallis test, analysis of variance, and the Wilcoxon signed rank-sum test were used to compare changes from baseline to endpoint after treatment.|
1720169|NCT00696761|3167749|Superiority or Other||||||<|0.05|||||||Kruskal-Wallis||||
1720170|NCT00696709|3167750|Other||Difference in Percentage|0.0|||||2-Sided|95.0|-10.8|6.0|||||Miettinen & Nurminen||
1720171|NCT00696709|3167750|Other||Difference in Percentage|0.0|||||2-Sided|95.0|-10.8|5.7|||||Miettinen & Nurminen||
1720172|NCT00696709|3167751|Other||Difference in Percentage|1.6||||0.469|2-Sided|95.0|-9.2|8.8|||Miettinen & Nurminen||||
1720173|NCT00696709|3167751|Other||Difference in Percentage|1.6||||0.48|2-Sided|95.0|-9.3|8.4|||Miettinen & Nurminen||||
1720174|NCT00696709|3167752|Other||Difference in Percentage|4.1|||||2-Sided|95.0|-16.9|24.9|||||Miettinen & Nurminen||
1720175|NCT00696709|3167752|Other||Difference in Percentage|-4.7|||||2-Sided|95.0|-25.3|16.1|||||Miettinen & Nurminen||
1720176|NCT00696709|3167753|Other||Difference in Percentage|40.4|||<|0.001|2-Sided|95.0|19.6|57.0|||Miettinen & Nurminen||||
1720177|NCT00696709|3167753|Other||Difference in Percentage|35.9|||<|0.001|2-Sided|95.0|15.2|52.6|||Miettinen & Nurminen||||
1720178|NCT00696709|3167754|Other||Difference in Percentage|1.6|||||2-Sided|95.0|-9.2|8.8|||||Miettinen & Nurminen||
1720179|NCT00696709|3167754|Other||Difference in Percentage|0.0|||||2-Sided|95.0|-10.8|5.7|||||Miettinen & Nurminen||
1720180|NCT00696709|3167755|Other|The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is >1.0.|||||<|0.0001|||||||Longitudinal data analysis (LDA)|LDA with log-transformed VZV responses at each visit as response variables and visit as covariate.|||
1720181|NCT00696709|3167756|Other||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is >1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.|||
1720182|NCT00696709|3167757|Other||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is >1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.|||
1720183|NCT00696709|3167758|Other||||||<|0.0001||||||The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is >1.0.|Longitudinal regression (LR)|Calculated based on LR model (adjusting for pre-vaccination immunogenicity level and incomplete data) with visit as covariate.|||
1720184|NCT00696657|3167796|Other||Estimated treatment differences|-0.68|||||2-Sided|95.0|-0.97|-0.4||||||The comparison sequence should be read as “Liraglutide 1.2 mg – Placebo”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720185|NCT00696657|3167796|Other||Estimated treatment differences|0.59|||||2-Sided|95.0|0.31|0.88||||||The comparison sequence should be read as “Semaglutide 0.1 mg – Liraglutide 1.2 mg”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720186|NCT00696657|3167796|Other||Estimated treatment differences|0.28|||||2-Sided|95.0|-0.02|0.57||||||The comparison sequence should be read as “Semaglutide 0.2 mg – Liraglutide 1.2 mg”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720187|NCT00696657|3167796|Other||Estimated treatment differences|0.08|||||2-Sided|95.0|-0.22|0.37||||||The comparison sequence should be read as “Semaglutide 0.4 mg – Liraglutide 1.2 mg”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720188|NCT00696657|3167796|Other||Estimated treatment differences|-0.29|||||2-Sided|95.0|-0.58|0.01||||||The comparison sequence should be read as “Semaglutide 0.8 mg – Liraglutide 1.2 mg”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720189|NCT00696657|3167796|Other||Estimated treatment differences|-0.27|||||2-Sided|95.0|-0.56|0.02||||||The comparison sequence should be read as “Semaglutide 0.8 mg (with titration) – Liraglutide 1.2 mg”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720190|NCT00696657|3167796|Other||Estimated treatment differences|-0.51|||||2-Sided|95.0|-0.8|-0.22||||||The comparison sequence should be read as “Semaglutide 1.6 mg (with titration) – Liraglutide 1.2 mg”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720191|NCT00696657|3167796|Other||Estimated treatment differences|-0.84|||||2-Sided|95.0|-1.12|-0.56||||||The comparison sequence should be read as “Liraglutide 1.8 mg – Placebo ”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720192|NCT00696657|3167796|Other||Estimated treatment differences|0.75|||||2-Sided|95.0|0.48|1.03||||||The comparison sequence should be read as “Semaglutide 0.1 mg – Liraglutide 1.8 mg”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720193|NCT00696657|3167796|Other||Estimated treatment differences|0.44|||||2-Sided|95.0|0.15|0.73||||||The comparison sequence should be read as “Semaglutide 0.2 mg – Liraglutide 1.8 mg”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720194|NCT00696657|3167796|Other||Estimated treatment differences|0.24|||||2-Sided|95.0|-0.05|0.52||||||The comparison sequence should be read as “Semaglutide 0.4 mg – Liraglutide 1.8 mg”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720195|NCT00696657|3167796|Other||Estimated treatment differences|-0.13|||||2-Sided|95.0|-0.42|0.16||||||The comparison sequence should be read as “Semaglutide 0.8 mg – Liraglutide 1.8 mg”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720196|NCT00696657|3167796|Other||Estimated treatment differences|-0.11|||||2-Sided|95.0|-0.39|0.18||||||The comparison sequence should be read as “Semaglutide 0.8 mg (with titration) – Liraglutide 1.8 mg”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720197|NCT00696657|3167796|Other||Estimated treatment differences|-0.35|||||2-Sided|95.0|-0.64|-0.06||||||The comparison sequence should be read as “Semaglutide 1.6 mg (with titration) – Liraglutide 1.8 mg”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720198|NCT00696657|3167796|Superiority||Estimated treatment differences|-0.09||||0.9772|2-Sided|95.0|-0.46|0.28|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||The comparison sequence should be read as “Semaglutide 0.1 mg – Placebo”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720199|NCT00696657|3167796|Superiority||Estimated treatment differences|-0.41||||0.0324|2-Sided|95.0|-0.79|-0.02|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||The comparison sequence should be read as “Semaglutide 0.2 mg – Placebo”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720200|NCT00696657|3167796|Superiority||Estimated treatment differences|-0.61||||0.0002|2-Sided|95.0|-0.98|-0.23|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||The comparison sequence should be read as “Semaglutide 0.4 mg – Placebo”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720201|NCT00696657|3167796|Superiority||Estimated treatment differences|-0.97|||<|0.0001|2-Sided|95.0|-1.35|-0.59|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||The comparison sequence should be read as “Semaglutide 0.8 mg – Placebo”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720202|NCT00696657|3167796|Superiority||Estimated treatment differences|-0.95|||<|0.0001|2-Sided|95.0|-1.33|-0.57|||ANOVA|CIs for treatment differences versus placebo are based on Dunnett's method.||The comparison sequence should be read as “Semaglutide 0.8 mg (with titration) – Placebo”. The estimates are from an ANOVA model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720252|NCT00696436|3167809|Superiority or Other||Mean Difference (Final Values)|-0.72||||0.341|2-Sided|95.0|-2.21|0.77||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720203|NCT00696657|3167796|Superiority||Estimated treatment differences|-1.19|||<|0.0001|2-Sided|95.0|-1.58|-0.8|||ANOVA|Confidence interval (CIs) for treatment differences versus placebo are based on Dunnett's method.||The comparison sequence should be read as “Semaglutide 1.6 mg (with titration) – Placebo”. The estimates are from an analysis of variance (ANOVA) model with treatment, country and previous treatment as fixed effects and baseline HbA1c as covariate.|
1720204|NCT00696618|3167797|Superiority or Other||||||<|0.05|||||||mulit-level analysis||||
1720205|NCT00696618|3167798|Superiority or Other||||||<|0.05|||||||multi-level||||
1720206|NCT00696618|3167799|Superiority or Other||||||<|0.05||||||Adjusted for multiple comparisons.|multi-level|||Nine research participants provided the ability to detect an effect size of 1.25 standard deviation units relative to the mean with 80% power using two-sided, 5% alpha in a paired analysis. The Baseline condition (no intervention) was assigned a value of 1 and geometric mean ratios with 95% confidence intervals for each intervention were calculated relative to baseline.|
1720207|NCT00696436|3167802|Superiority or Other||Odds Ratio (OR)|1.23||||0.234|2-Sided|95.0|0.87|1.73||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720208|NCT00696436|3167802|Superiority or Other||Odds Ratio (OR)|1.19||||0.317|2-Sided|95.0|0.85|1.66||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720209|NCT00696436|3167802|Superiority or Other||Odds Ratio (OR)|1.44||||0.036|2-Sided|95.0|1.02|2.02||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720210|NCT00696436|3167802|Superiority or Other||Odds Ratio (OR)|1.39||||0.056|2-Sided|95.0|0.99|1.94||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720211|NCT00696436|3167802|Superiority or Other||Odds Ratio (OR)|4.43|||<|0.001|2-Sided|95.0|2.73|7.19||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720212|NCT00696436|3167802|Superiority or Other||Odds Ratio (OR)|5.18|||<|0.001|2-Sided|95.0|3.2|8.41||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720213|NCT00696436|3167803|Superiority or Other||Odds Ratio (OR)|1.19||||0.381|2-Sided|95.0|0.81|1.74||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720214|NCT00696436|3167803|Superiority or Other||Odds Ratio (OR)|1.08||||0.695|2-Sided|95.0|0.74|1.58||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720215|NCT00696436|3167803|Superiority or Other||Odds Ratio (OR)|1.34||||0.132|2-Sided|95.0|0.92|1.97||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720216|NCT00696436|3167803|Superiority or Other||Odds Ratio (OR)|1.22||||0.306|2-Sided|95.0|0.83|1.8||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720217|NCT00696436|3167803|Superiority or Other||Odds Ratio (OR)|2.91|||<|0.001|2-Sided|95.0|1.86|4.54||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720218|NCT00696436|3167803|Superiority or Other||Odds Ratio (OR)|3.29|||<|0.001|2-Sided|95.0|2.1|5.15||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720219|NCT00696436|3167804|Superiority or Other||Odds Ratio (OR)|1.37||||0.071|2-Sided|95.0|0.97|1.92||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720220|NCT00696436|3167804|Superiority or Other||Odds Ratio (OR)|1.35||||0.08|2-Sided|95.0|0.96|1.89||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720221|NCT00696436|3167804|Superiority or Other||Odds Ratio (OR)|1.46||||0.029|2-Sided|95.0|1.04|2.06||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720222|NCT00696436|3167804|Superiority or Other||Odds Ratio (OR)|1.45||||0.032|2-Sided|95.0|1.03|2.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720223|NCT00696436|3167804|Superiority or Other||Odds Ratio (OR)|4.66|||<|0.001|2-Sided|95.0|2.94|7.37||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720224|NCT00696436|3167804|Superiority or Other||Odds Ratio (OR)|4.98|||<|0.001|2-Sided|95.0|3.15|7.88||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value was presented.|Regression, Logistic||||
1720225|NCT00696436|3167805|Superiority or Other||Mean Difference (Final Values)|-2.46||||0.008|2-Sided|95.0|-4.27|-0.66||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720226|NCT00696436|3167805|Superiority or Other||Mean Difference (Final Values)|-0.44||||0.625|2-Sided|95.0|-2.2|1.32||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720227|NCT00696436|3167805|Superiority or Other||Mean Difference (Final Values)|-2.39||||0.01|2-Sided|95.0|-4.2|-0.57||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720228|NCT00696436|3167805|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.691|2-Sided|95.0|-2.14|1.42||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720229|NCT00696436|3167805|Superiority or Other||Mean Difference (Final Values)|-7.99|||<|0.001|2-Sided|95.0|-10.1|-5.88||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720230|NCT00696436|3167805|Superiority or Other||Mean Difference (Final Values)|-7.91|||<|0.001|2-Sided|95.0|-10.03|-5.79||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720231|NCT00696436|3167806|Superiority or Other||Mean Difference (Final Values)|-3.32||||0.007|2-Sided|95.0|-5.72|-0.93||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720232|NCT00696436|3167806|Superiority or Other||Mean Difference (Final Values)|-0.82||||0.494|2-Sided|95.0|-3.16|1.53||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720233|NCT00696436|3167806|Superiority or Other||Mean Difference (Final Values)|-4.24|||<|0.001|2-Sided|95.0|-6.65|-1.83||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720234|NCT00696436|3167806|Superiority or Other||Mean Difference (Final Values)|-1.74|||<|0.149|2-Sided|95.0|-4.1|0.62||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720235|NCT00696436|3167806|Superiority or Other||Mean Difference (Final Values)|-11.91|||<|0.001|2-Sided|95.0|-14.72|-9.11||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720236|NCT00696436|3167806|Superiority or Other||Mean Difference (Final Values)|-12.84|||<|0.001|2-Sided|95.0|-15.66|-10.02||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720237|NCT00696436|3167807|Superiority or Other||Mean Difference (Final Values)|-1.74||||0.024|2-Sided|95.0|-3.25|-0.22||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720238|NCT00696436|3167807|Superiority or Other||Mean Difference (Final Values)|-1.34||||0.076|2-Sided|95.0|-2.82|0.14||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720239|NCT00696436|3167807|Superiority or Other||Mean Difference (Final Values)|-2.71|||<|0.001|2-Sided|95.0|-4.24|-1.19||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720240|NCT00696436|3167807|Superiority or Other||Mean Difference (Final Values)|-2.31|||<|0.002|2-Sided|95.0|-3.81|-0.82||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720241|NCT00696436|3167807|Superiority or Other||Mean Difference (Final Values)|-9.17|||<|0.001|2-Sided|95.0|-10.94|-7.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720242|NCT00696436|3167807|Superiority or Other||Mean Difference (Final Values)|-10.14|||<|0.001|2-Sided|95.0|-11.92|-8.36||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720243|NCT00696436|3167808|Superiority or Other||Mean Difference (Final Values)|-3.59|||<|0.001|2-Sided|95.0|-5.72|-1.46||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720244|NCT00696436|3167808|Superiority or Other||Mean Difference (Final Values)|-1.8|||<|0.091|2-Sided|95.0|-3.88|0.29||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720245|NCT00696436|3167808|Superiority or Other||Mean Difference (Final Values)|-5.11|||<|0.001|2-Sided|95.0|-7.26|-2.97||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720246|NCT00696436|3167808|Superiority or Other||Mean Difference (Final Values)|-3.32|||<|0.002|2-Sided|95.0|-5.42|-1.22||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720247|NCT00696436|3167808|Superiority or Other||Mean Difference (Final Values)|-13.93|||<|0.001|2-Sided|95.0|-16.42|-11.43||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720248|NCT00696436|3167808|Superiority or Other||Mean Difference (Final Values)|-15.45|||<|0.001|2-Sided|95.0|-17.96|-12.94||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720249|NCT00696436|3167809|Superiority or Other||Mean Difference (Final Values)|-1.39||||0.071|2-Sided|95.0|-2.89|0.12||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720253|NCT00696436|3167809|Superiority or Other||Mean Difference (Final Values)|-7.75|||<|0.001|2-Sided|95.0|-9.52|-5.99||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720254|NCT00696436|3167809|Superiority or Other||Mean Difference (Final Values)|-8.64|||<|0.001|2-Sided|95.0|-10.42|-6.87||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720255|NCT00696436|3167810|Superiority or Other||Mean Difference (Final Values)|-2.62||||0.018|2-Sided|95.0|-4.79|-0.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720256|NCT00696436|3167810|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.72|2-Sided|95.0|-2.51|1.73||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720257|NCT00696436|3167810|Superiority or Other||Mean Difference (Final Values)|-3.65||||0.001|2-Sided|95.0|-5.84|-1.46||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720258|NCT00696436|3167810|Superiority or Other||Mean Difference (Final Values)|-1.42||||0.194|2-Sided|95.0|-3.56|0.72||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720259|NCT00696436|3167810|Superiority or Other||Mean Difference (Final Values)|-11.97|||<|0.001|2-Sided|95.0|-14.51|-9.43||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720260|NCT00696436|3167810|Superiority or Other||Mean Difference (Final Values)|-13.0|||<|0.001|2-Sided|95.0|-15.56|-10.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720261|NCT00696436|3167811|Superiority or Other||Mean Difference (Final Values)|-1.73||||0.017|2-Sided|95.0|-3.15|-0.3||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720262|NCT00696436|3167811|Superiority or Other||Mean Difference (Final Values)|-1.14||||0.107|2-Sided|95.0|-2.53|0.25||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720263|NCT00696436|3167811|Superiority or Other||Mean Difference (Final Values)|-2.57|||<|0.001|2-Sided|95.0|-4.0|-1.14||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720264|NCT00696436|3167811|Superiority or Other||Mean Difference (Final Values)|-1.99|||<|0.006|2-Sided|95.0|-3.39|-0.58||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720265|NCT00696436|3167811|Superiority or Other||Mean Difference (Final Values)|-8.96|||<|0.001|2-Sided|95.0|-10.63|-7.3||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720266|NCT00696436|3167811|Superiority or Other||Mean Difference (Final Values)|-9.81|||<|0.001|2-Sided|95.0|-11.48|-8.13||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720267|NCT00696436|3167812|Superiority or Other||Mean Difference (Final Values)|-3.47|||<|0.001|2-Sided|95.0|-5.49|-1.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720268|NCT00696436|3167812|Superiority or Other||Mean Difference (Final Values)|-1.57|||<|0.119|2-Sided|95.0|-3.55|0.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720269|NCT00696436|3167812|Superiority or Other||Mean Difference (Final Values)|-4.76|||<|0.001|2-Sided|95.0|-6.8|-2.73||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720270|NCT00696436|3167812|Superiority or Other||Mean Difference (Final Values)|-2.86|||<|0.005|2-Sided|95.0|-4.85|-0.87||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720271|NCT00696436|3167812|Superiority or Other||Mean Difference (Final Values)|-13.63|||<|0.001|2-Sided|95.0|-15.99|-11.27||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720272|NCT00696436|3167812|Superiority or Other||Mean Difference (Final Values)|-14.92|||<|0.001|2-Sided|95.0|-17.3|-12.54||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720273|NCT00696436|3167813|Superiority or Other||Mean Difference (Final Values)|-1.86||||0.017|2-Sided|95.0|-3.39|-0.33||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720274|NCT00696436|3167813|Superiority or Other||Mean Difference (Final Values)|-0.87||||0.257|2-Sided|95.0|-2.39|0.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720275|NCT00696436|3167813|Superiority or Other||Mean Difference (Final Values)|-3.17|||<|0.001|2-Sided|95.0|-4.69|-1.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720276|NCT00696436|3167813|Superiority or Other||Mean Difference (Final Values)|-2.18|||<|0.005|2-Sided|95.0|-3.69|-0.67||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720277|NCT00696436|3167813|Superiority or Other||Mean Difference (Final Values)|-6.21|||<|0.001|2-Sided|95.0|-8.03|-4.39||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720278|NCT00696436|3167813|Superiority or Other||Mean Difference (Final Values)|-7.51|||<|0.001|2-Sided|95.0|-9.33|-5.69||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720551|NCT00692198|3168200|Superiority or Other||Hazard Ratio (HR)|0.94||||0.52|2-Sided|95.0|0.79|1.12|||Log Rank||||
1720279|NCT00696436|3167814|Superiority or Other||Mean Difference (Final Values)|-1.56||||0.02|2-Sided|95.0|-2.88|-0.24||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720280|NCT00696436|3167814|Superiority or Other||Mean Difference (Final Values)|-0.91||||0.166|2-Sided|95.0|-2.19|0.38||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720281|NCT00696436|3167814|Superiority or Other||Mean Difference (Final Values)|-2.35|||<|0.001|2-Sided|95.0|-3.67|-1.02||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720282|NCT00696436|3167814|Superiority or Other||Mean Difference (Final Values)|-1.7|||<|0.011|2-Sided|95.0|-2.99|-0.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720283|NCT00696436|3167814|Superiority or Other||Mean Difference (Final Values)|-8.58|||<|0.001|2-Sided|95.0|-10.12|-7.04||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720284|NCT00696436|3167814|Superiority or Other||Mean Difference (Final Values)|-9.36|||<|0.001|2-Sided|95.0|-10.91|-7.81||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented.|ANCOVA||||
1720285|NCT00696436|3167815|Superiority or Other||Mean Difference (Final Values)|-5.07|||<|0.001|2-Sided|95.0|-7.73|-2.42||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA||||
1720286|NCT00696436|3167815|Superiority or Other||Mean Difference (Final Values)|-3.18|||<|0.018|2-Sided|95.0|-5.81|-0.55||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA||||
1720287|NCT00696436|3167815|Superiority or Other||Mean Difference (Final Values)|-5.43|||<|0.001|2-Sided|95.0|-8.09|-2.78||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA||||
1720288|NCT00696436|3167815|Superiority or Other||Mean Difference (Final Values)|-3.54|||<|0.008|2-Sided|95.0|-6.17|-0.92||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA||||
1720289|NCT00696436|3167815|Superiority or Other||Mean Difference (Final Values)|-14.55|||<|0.001|2-Sided|95.0|-17.71|-11.4||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA||||
1720290|NCT00696436|3167815|Superiority or Other||Mean Difference (Final Values)|-14.92|||<|0.001|2-Sided|95.0|-18.07|-11.76||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA||||
1720291|NCT00696436|3167816|Superiority or Other||Mean Difference (Final Values)|-3.2||||0.001|2-Sided|95.0|-5.12|-1.27||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA||||
1720292|NCT00696436|3167816|Superiority or Other||Mean Difference (Final Values)|-1.43||||0.136|2-Sided|95.0|-3.31|0.45||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA||||
1720293|NCT00696436|3167816|Superiority or Other||Mean Difference (Final Values)|-4.31|||<|0.001|2-Sided|95.0|-6.25|-2.37||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA||||
1720294|NCT00696436|3167816|Superiority or Other||Mean Difference (Final Values)|-2.54|||<|0.009|2-Sided|95.0|-4.44|-0.64||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA||||
1720295|NCT00696436|3167816|Superiority or Other||Mean Difference (Final Values)|-13.16|||<|0.001|2-Sided|95.0|-15.41|-10.91||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA||||
1720296|NCT00696436|3167816|Superiority or Other||Mean Difference (Final Values)|-14.27|||<|0.001|2-Sided|95.0|-16.54|-12.01||Postbaseline P-value was from ANCOVA with treatment as a factor and baseline value as a covariate. Unadjusted p-value was presented. Overall 0.05 level of significance for multiple comparisons was controlled using stepwise testing procedure.|ANCOVA||||
1720297|NCT00696410|3167830|Superiority or Other|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)|
1720298|NCT00696410|3167830|Superiority or Other|||||||0.92|||||||Sign test|||p value represents test of paired (within patient) difference|
1720299|NCT00696410|3167831|Superiority or Other|||||||0.39|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)|
1720300|NCT00696410|3167831|Superiority or Other|||||||0.48|||||||Sign test|||p value represents test of paired (within patient) difference|
1720301|NCT00696410|3167832|Superiority or Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)|
1720302|NCT00696410|3167832|Superiority or Other|||||||0.69|||||||Sign test|||p value represents test of paired (within patient) difference|
1720304|NCT00696410|3167833|Superiority or Other|||||||0.71|||||||Sign test|||p value represents test of paired (within patient) difference|
1720305|NCT00696410|3167834|Superiority or Other|||||||0.022|||||||Wilcoxon (Mann-Whitney)|||p value tests difference between the marker in CHF patients at time 0 and Health Controls (between group)|
1720306|NCT00696410|3167834|Superiority or Other|||||||0.068|||||||Wilcoxon (Mann-Whitney)|||p value represents test of paired (within patient) difference|
1720307|NCT00696384|3167839|Superiority or Other||Mean Difference (Final Values)|-12.38|||<|0.001|2-Sided|95.0|-15.47|-9.29||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Includes participants with both a double-blind baseline and postbaseline value.|ANCOVA||||
1720308|NCT00696384|3167840|Superiority or Other||Mean Difference (Final Values)|-7.78|||<|0.001|2-Sided|95.0|-9.78|-5.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Includes participants with both a double-blind baseline and postbaseline value.|ANCOVA||||
1720309|NCT00696241|3167843|Superiority or Other||Odds Ratio (OR)|1.2||||0.276|2-Sided|95.0|0.86|1.68||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720310|NCT00696241|3167843|Superiority or Other||Odds Ratio (OR)|0.9||||0.537|2-Sided|95.0|0.64|1.26||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720311|NCT00696241|3167843|Superiority or Other||Odds Ratio (OR)|0.81||||0.217|2-Sided|95.0|0.58|1.13||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720312|NCT00696241|3167843|Superiority or Other||Odds Ratio (OR)|6.75|||<|0.001|2-Sided|95.0|3.96|11.48||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720313|NCT00696241|3167843|Superiority or Other||Odds Ratio (OR)|5.04|||<|0.001|2-Sided|95.0|2.96|8.58||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720314|NCT00696241|3167843|Superiority or Other||Odds Ratio (OR)|4.53|||<|0.001|2-Sided|95.0|2.66|7.72||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720315|NCT00696241|3167844|Superiority or Other||Odds Ratio (OR)|1.02||||0.928|2-Sided|95.0|0.68|1.52||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720316|NCT00696241|3167844|Superiority or Other||Odds Ratio (OR)|0.91||||0.628|2-Sided|95.0|0.61|1.35||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720317|NCT00696241|3167844|Superiority or Other||Odds Ratio (OR)|0.76||||0.177|2-Sided|95.0|0.52|1.13||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720318|NCT00696241|3167844|Superiority or Other||Odds Ratio (OR)|3.81|||<|0.001|2-Sided|95.0|2.41|6.02||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720319|NCT00696241|3167844|Superiority or Other||Odds Ratio (OR)|3.39|||<|0.001|2-Sided|95.0|2.15|5.35||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720320|NCT00696241|3167844|Superiority or Other||Odds Ratio (OR)|2.86|||<|0.001|2-Sided|95.0|1.82|4.48||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720321|NCT00696241|3167845|Superiority or Other||Odds Ratio (OR)|1.15||||0.402|2-Sided|95.0|0.83|1.62||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720322|NCT00696241|3167845|Superiority or Other||Odds Ratio (OR)|0.88||||0.449|2-Sided|95.0|0.63|1.23||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720323|NCT00696241|3167845|Superiority or Other||Odds Ratio (OR)|0.79||||0.173|2-Sided|95.0|0.57|1.11||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720324|NCT00696241|3167845|Superiority or Other||Odds Ratio (OR)|6.53|||<|0.001|2-Sided|95.0|3.95|10.79||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720325|NCT00696241|3167845|Superiority or Other||Odds Ratio (OR)|4.97|||<|0.001|2-Sided|95.0|3.01|8.2||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720326|NCT00696241|3167845|Superiority or Other||Odds Ratio (OR)|4.48|||<|0.001|2-Sided|95.0|2.71|7.39||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1720327|NCT00696241|3167846|Superiority or Other||Mean Difference (Final Values)|-1.11||||0.196|2-Sided|95.0|-2.8|0.57||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720328|NCT00696241|3167846|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.672|2-Sided|95.0|-2.05|1.32||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720329|NCT00696241|3167846|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.642|2-Sided|95.0|-2.09|1.29||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720330|NCT00696241|3167846|Superiority or Other||Mean Difference (Final Values)|-7.55|||<|0.001|2-Sided|95.0|-9.64|-5.47||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720331|NCT00696241|3167846|Superiority or Other||Mean Difference (Final Values)|-6.8|||<|0.001|2-Sided|95.0|-8.89|-4.72||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720332|NCT00696241|3167846|Superiority or Other||Mean Difference (Final Values)|-6.84|||<|0.001|2-Sided|95.0|-8.93|-4.75||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720333|NCT00696241|3167847|Superiority or Other||Mean Difference (Final Values)|-2.33||||0.054|2-Sided|95.0|-4.7|0.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720334|NCT00696241|3167847|Superiority or Other||Mean Difference (Final Values)|-1.29||||0.285|2-Sided|95.0|-3.66|1.08||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720335|NCT00696241|3167847|Superiority or Other||Mean Difference (Final Values)|-1.05||||0.385|2-Sided|95.0|-3.43|1.33||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720336|NCT00696241|3167847|Superiority or Other||Mean Difference (Final Values)|-12.21|||<|0.001|2-Sided|95.0|-15.15|-9.28||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720337|NCT00696241|3167847|Superiority or Other||Mean Difference (Final Values)|-11.18|||<|0.001|2-Sided|95.0|-14.11|-8.24||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720338|NCT00696241|3167847|Superiority or Other||Mean Difference (Final Values)|-10.94|||<|0.001|2-Sided|95.0|-13.88|-8.0||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720339|NCT00696241|3167848|Superiority or Other||Mean Difference (Final Values)|-1.02||||0.161|2-Sided|95.0|-2.44|0.41||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720340|NCT00696241|3167848|Superiority or Other||Mean Difference (Final Values)|-0.77||||0.29|2-Sided|95.0|-2.19|0.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720341|NCT00696241|3167848|Superiority or Other||Mean Difference (Final Values)|0.14||||0.845|2-Sided|95.0|-1.29|1.57||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720342|NCT00696241|3167848|Superiority or Other||Mean Difference (Final Values)|-8.41|||<|0.001|2-Sided|95.0|-10.17|-6.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720343|NCT00696241|3167848|Superiority or Other||Mean Difference (Final Values)|-8.16|||<|0.001|2-Sided|95.0|-9.92|-6.4||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720344|NCT00696241|3167848|Superiority or Other||Mean Difference (Final Values)|-7.25|||<|0.001|2-Sided|95.0|-9.02|-5.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720345|NCT00696241|3167849|Superiority or Other||Mean Difference (Final Values)|-2.1||||0.059|2-Sided|95.0|-4.28|0.08||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720346|NCT00696241|3167849|Superiority or Other||Mean Difference (Final Values)|-0.98||||0.378|2-Sided|95.0|-3.16|1.2||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720347|NCT00696241|3167849|Superiority or Other||Mean Difference (Final Values)|0.35||||0.75|2-Sided|95.0|-1.83|2.54||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720348|NCT00696241|3167849|Superiority or Other||Mean Difference (Final Values)|-13.81|||<|0.001|2-Sided|95.0|-16.51|-11.11||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720349|NCT00696241|3167849|Superiority or Other||Mean Difference (Final Values)|-12.68|||<|0.001|2-Sided|95.0|-15.38|-9.98||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720350|NCT00696241|3167849|Superiority or Other||Mean Difference (Final Values)|-11.35|||<|0.001|2-Sided|95.0|-14.05|-8.64||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720351|NCT00696241|3167850|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.818|2-Sided|95.0|-1.63|1.29||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720769|NCT00689117|3168529|Superiority or Other|||||||0.671|||||||Cochran-Mantel-Haenszel||||
1720352|NCT00696241|3167850|Superiority or Other||Mean Difference (Final Values)|-0.27||||0.712|2-Sided|95.0|-1.74|1.19||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720353|NCT00696241|3167850|Superiority or Other||Mean Difference (Final Values)|0.64||||0.394|2-Sided|95.0|-0.83|2.1||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720354|NCT00696241|3167850|Superiority or Other||Mean Difference (Final Values)|-6.84|||<|0.001|2-Sided|95.0|-8.65|-5.03||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720355|NCT00696241|3167850|Superiority or Other||Mean Difference (Final Values)|-6.94|||<|0.001|2-Sided|95.0|-8.75|-5.13||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720356|NCT00696241|3167850|Superiority or Other||Mean Difference (Final Values)|-6.03|||<|0.001|2-Sided|95.0|-7.84|-4.21||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720357|NCT00696241|3167851|Superiority or Other||Mean Difference (Final Values)|-1.21||||0.267|2-Sided|95.0|-3.35|0.93||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720358|NCT00696241|3167851|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.811|2-Sided|95.0|-2.4|1.88||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720359|NCT00696241|3167851|Superiority or Other||Mean Difference (Final Values)|1.03||||0.346|2-Sided|95.0|-1.12|3.18||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720360|NCT00696241|3167851|Superiority or Other||Mean Difference (Final Values)|-12.38|||<|0.001|2-Sided|95.0|-15.03|-9.73||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720361|NCT00696241|3167851|Superiority or Other||Mean Difference (Final Values)|-11.43|||<|0.001|2-Sided|95.0|-14.07|-8.78||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720362|NCT00696241|3167851|Superiority or Other||Mean Difference (Final Values)|-10.13|||<|0.001|2-Sided|95.0|-12.79|-7.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720363|NCT00696241|3167852|Superiority or Other||Mean Difference (Final Values)|-1.05||||0.126|2-Sided|95.0|-2.39|0.3||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720364|NCT00696241|3167852|Superiority or Other||Mean Difference (Final Values)|-0.62||||0.369|2-Sided|95.0|-1.96|0.73||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720365|NCT00696241|3167852|Superiority or Other||Mean Difference (Final Values)|0.11||||0.877|2-Sided|95.0|-1.24|1.45||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720366|NCT00696241|3167852|Superiority or Other||Mean Difference (Final Values)|-8.28|||<|0.001|2-Sided|95.0|-9.94|-6.61||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720367|NCT00696241|3167852|Superiority or Other||Mean Difference (Final Values)|-7.84|||<|0.001|2-Sided|95.0|-9.51|-6.18||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720368|NCT00696241|3167852|Superiority or Other||Mean Difference (Final Values)|-7.12|||<|0.001|2-Sided|95.0|-8.79|-5.45||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720369|NCT00696241|3167853|Superiority or Other||Mean Difference (Final Values)|-2.22||||0.034|2-Sided|95.0|-4.28|-0.16||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720370|NCT00696241|3167853|Superiority or Other||Mean Difference (Final Values)|-1.01||||0.334|2-Sided|95.0|-3.07|1.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720371|NCT00696241|3167853|Superiority or Other||Mean Difference (Final Values)|0.16||||0.879|2-Sided|95.0|-1.9|2.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720372|NCT00696241|3167853|Superiority or Other||Mean Difference (Final Values)|-13.41|||<|0.001|2-Sided|95.0|-15.97|-10.86||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720373|NCT00696241|3167853|Superiority or Other||Mean Difference (Final Values)|-12.2|||<|0.001|2-Sided|95.0|-14.75|-9.65||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720374|NCT00696241|3167853|Superiority or Other||Mean Difference (Final Values)|-11.03|||<|0.001|2-Sided|95.0|-13.59|-8.48||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720375|NCT00696241|3167854|Superiority or Other||Mean Difference (Final Values)|-1.51||||0.044|2-Sided|95.0|-2.98|-0.04||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720376|NCT00696241|3167854|Superiority or Other||Mean Difference (Final Values)|0.04||||0.956|2-Sided|95.0|-1.43|1.52||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720377|NCT00696241|3167854|Superiority or Other||Mean Difference (Final Values)|0.09||||0.908|2-Sided|95.0|-1.39|1.56||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720578|NCT00689936|3168430|Superiority or Other (legacy)||Odds Ratio (OR)|2.62||||0.00043|2-Sided|95.0|1.55|4.45|||Fisher Exact||||
1720378|NCT00696241|3167854|Superiority or Other||Mean Difference (Final Values)|-8.62|||<|0.001|2-Sided|95.0|-10.42|-6.82||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720379|NCT00696241|3167854|Superiority or Other||Mean Difference (Final Values)|-7.07|||<|0.001|2-Sided|95.0|-8.87|-5.27||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720380|NCT00696241|3167854|Superiority or Other||Mean Difference (Final Values)|-7.02|||<|0.001|2-Sided|95.0|-8.83|-5.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720381|NCT00696241|3167855|Superiority or Other||Mean Difference (Final Values)|-0.87||||0.172|2-Sided|95.0|-2.13|0.38||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720382|NCT00696241|3167855|Superiority or Other||Mean Difference (Final Values)|-0.64||||0.319|2-Sided|95.0|-1.89|0.62||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720383|NCT00696241|3167855|Superiority or Other||Mean Difference (Final Values)|0.27||||0.679|2-Sided|95.0|-0.99|1.52||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720384|NCT00696241|3167855|Superiority or Other||Mean Difference (Final Values)|-7.92|||<|0.001|2-Sided|95.0|-9.47|-6.36||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720385|NCT00696241|3167855|Superiority or Other||Mean Difference (Final Values)|-7.68|||<|0.001|2-Sided|95.0|-9.24|-6.13||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720386|NCT00696241|3167855|Superiority or Other||Mean Difference (Final Values)|-6.78|||<|0.001|2-Sided|95.0|-8.34|-5.22||P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1720387|NCT00696241|3167856|Superiority or Other||Mean Difference (Final Values)|-2.71||||0.043|2-Sided|95.0|-5.34|-0.09||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1720388|NCT00696241|3167856|Superiority or Other||Mean Difference (Final Values)|0.4||||0.768|2-Sided|95.0|-2.24|3.03||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1720389|NCT00696241|3167856|Superiority or Other||Mean Difference (Final Values)|0.59||||0.662|2-Sided|95.0|-2.05|3.22||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1720390|NCT00696241|3167856|Superiority or Other||Mean Difference (Final Values)|-15.53|||<|0.001|2-Sided|95.0|-18.74|-12.31||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1720391|NCT00696241|3167856|Superiority or Other||Mean Difference (Final Values)|-12.42|||<|0.001|2-Sided|95.0|-15.64|-9.2||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1720392|NCT00696241|3167856|Superiority or Other||Mean Difference (Final Values)|-12.23|||<|0.001|2-Sided|95.0|-15.45|-9.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1720393|NCT00696241|3167857|Superiority or Other||Mean Difference (Final Values)|-2.06||||0.038|2-Sided|95.0|-4.0|-0.12||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1720394|NCT00696241|3167857|Superiority or Other||Mean Difference (Final Values)|-0.92||||0.352|2-Sided|95.0|-2.87|1.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1720395|NCT00696241|3167857|Superiority or Other||Mean Difference (Final Values)|0.4||||0.687|2-Sided|95.0|-1.55|2.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1720396|NCT00696241|3167857|Superiority or Other||Mean Difference (Final Values)|-13.21|||<|0.001|2-Sided|95.0|-15.62|-10.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1720397|NCT00696241|3167857|Superiority or Other||Mean Difference (Final Values)|-12.08|||<|0.001|2-Sided|95.0|-14.48|-9.67||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1720398|NCT00696241|3167857|Superiority or Other||Mean Difference (Final Values)|-10.75|||<|0.001||95.0|-13.17|-8.34||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1720446|NCT00695097|3167969|Superiority or Other|||||||0.25||||||P < 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (Baseline)compared to post-treatment (follow-up) CD3 cell density|
1720399|NCT00696020|3167878|Superiority or Other||Mean Difference (Final Values)|18.893|Standard Error of the Mean|7.844||0.0166|2-Sided|95.0|3.458|34.329|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720400|NCT00696020|3167878|Superiority or Other||Mean Difference (Final Values)|19.817|Standard Error of the Mean|7.759||0.0111|2-Sided|95.0|4.549|35.084|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720401|NCT00696020|3167878|Superiority or Other||Mean Difference (Final Values)|13.106|Standard Error of the Mean|7.704||0.0899|2-Sided|95.0|-2.055|28.267|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720402|NCT00696020|3167879|Superiority or Other||Mean Difference (Final Values)|0.035|Standard Error of the Mean|0.048||0.4654|2-Sided|95.0|-0.06|0.13|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720403|NCT00696020|3167879|Superiority or Other||Mean Difference (Final Values)|0.048|Standard Error of the Mean|0.048||0.3171|2-Sided|95.0|-0.046|0.143|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720404|NCT00696020|3167879|Superiority or Other||Mean Difference (Final Values)|0.044|Standard Error of the Mean|0.048||0.3517|2-Sided|95.0|-0.049|0.138|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720405|NCT00696020|3167881|Superiority or Other||Mean Difference (Final Values)|29.357|Standard Error of the Mean|7.105|<|0.0001|2-Sided|95.0|15.379|43.335|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720406|NCT00696020|3167881|Superiority or Other||Mean Difference (Final Values)|18.695|Standard Error of the Mean|6.981|<|0.0078|2-Sided|95.0|4.961|32.43|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720407|NCT00696020|3167881|Superiority or Other||Mean Difference (Final Values)|23.414|Standard Error of the Mean|7.057|<|0.001|2-Sided|95.0|9.529|37.3|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720408|NCT00696020|3167882|Superiority or Other||Mean Difference (Final Values)|0.265|Standard Error of the Mean|0.06|<|0.0001|2-Sided|95.0|0.147|0.383|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720409|NCT00696020|3167882|Superiority or Other||Mean Difference (Final Values)|0.204|Standard Error of the Mean|0.059|<|0.0007|2-Sided|95.0|0.087|0.32|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720410|NCT00696020|3167882|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.06|<|0.0296|2-Sided|95.0|0.013|0.249|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720411|NCT00696020|3167883|Superiority or Other||Mean Difference (Final Values)|0.144|Standard Error of the Mean|0.033|<|0.0001|2-Sided|95.0|0.08|0.209|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720412|NCT00696020|3167883|Superiority or Other||Mean Difference (Final Values)|0.082|Standard Error of the Mean|0.032|<|0.012|2-Sided|95.0|0.018|0.146|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720413|NCT00696020|3167883|Superiority or Other||Mean Difference (Final Values)|0.088|Standard Error of the Mean|0.033|<|0.0079|2-Sided|95.0|0.023|0.152|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720414|NCT00696020|3167884|Superiority or Other||Mean Difference (Final Values)|27.793|Standard Error of the Mean|6.859|<|0.0001|2-Sided|95.0|14.298|41.287|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720415|NCT00696020|3167884|Superiority or Other||Mean Difference (Final Values)|19.743|Standard Error of the Mean|6.739|<|0.0036|2-Sided|95.0|6.484|33.002|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720416|NCT00696020|3167884|Superiority or Other||Mean Difference (Final Values)|22.867|Standard Error of the Mean|6.813|<|0.0009|2-Sided|95.0|9.462|36.272|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720417|NCT00696020|3167885|Superiority or Other||Mean Difference (Final Values)|0.238|Standard Error of the Mean|0.056|<|0.0001|2-Sided|95.0|0.128|0.349|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720418|NCT00696020|3167885|Superiority or Other||Mean Difference (Final Values)|0.183|Standard Error of the Mean|0.055|<|0.0011|2-Sided|95.0|0.074|0.292|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720419|NCT00696020|3167885|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.056|<|0.0332|2-Sided|95.0|0.01|0.23|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720420|NCT00696020|3167886|Superiority or Other||Mean Difference (Final Values)|0.128|Standard Error of the Mean|0.031|<|0.0001|2-Sided|95.0|0.066|0.189|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720421|NCT00696020|3167886|Superiority or Other||Mean Difference (Final Values)|0.086|Standard Error of the Mean|0.031|<|0.0056|2-Sided|95.0|0.025|0.146|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720422|NCT00696020|3167886|Superiority or Other||Mean Difference (Final Values)|0.088|Standard Error of the Mean|0.031|<|0.0048|2-Sided|95.0|0.027|0.149|||ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720447|NCT00695019|3167970|Superiority or Other|||||||0.005|||||||Chi-squared||||
1720423|NCT00696020|3167887|Superiority or Other||Mean Difference (Final Values)|26.954|Standard Error of the Mean|6.805|<|0.0001|2-Sided|95.0|13.565|40.343|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720424|NCT00696020|3167887|Superiority or Other||Mean Difference (Final Values)|18.769|Standard Error of the Mean|6.687|<|0.0053|2-Sided|95.0|5.613|31.924|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720425|NCT00696020|3167887|Superiority or Other||Mean Difference (Final Values)|22.357|Standard Error of the Mean|6.76|<|0.001|2-Sided|95.0|9.057|35.657|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720426|NCT00696020|3167888|Superiority or Other||Mean Difference (Final Values)|0.239|Standard Error of the Mean|0.056|<|0.0001|2-Sided|95.0|0.13|0.349|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720427|NCT00696020|3167888|Superiority or Other||Mean Difference (Final Values)|0.184|Standard Error of the Mean|0.055|<|0.0009|2-Sided|95.0|0.076|0.292|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720428|NCT00696020|3167888|Superiority or Other||Mean Difference (Final Values)|0.116|Standard Error of the Mean|0.056|<|0.0384|2-Sided|95.0|0.006|0.225|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720429|NCT00696020|3167889|Superiority or Other||Mean Difference (Final Values)|0.125|Standard Error of the Mean|0.03|<|0.0001|2-Sided|95.0|0.066|0.185|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720430|NCT00696020|3167889|Superiority or Other||Mean Difference (Final Values)|0.079|Standard Error of the Mean|0.03|<|0.0086|2-Sided|95.0|0.02|0.138|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720431|NCT00696020|3167889|Superiority or Other||Mean Difference (Final Values)|0.085|Standard Error of the Mean|0.03|<|0.0052|2-Sided|95.0|0.026|0.145|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720432|NCT00696020|3167890|Superiority or Other||Mean Difference (Final Values)|0.117|Standard Error of the Mean|0.047||0.0125|2-Sided|95.0|0.025|0.209|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed)|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720433|NCT00696020|3167890|Superiority or Other||Mean Difference (Final Values)|0.099|Standard Error of the Mean|0.046||0.0321|2-Sided|95.0|0.009|0.189|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720434|NCT00696020|3167890|Superiority or Other||Mean Difference (Final Values)|0.002|Standard Error of the Mean|0.047||0.9573|2-Sided|95.0|-0.089|0.094|||ANCOVA|terms for baseline, treatment, centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720435|NCT00696020|3167891|Superiority or Other||Mean Difference (Final Values)|0.055|Standard Error of the Mean|0.026||0.038|2-Sided|95.0|0.003|0.107||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720436|NCT00696020|3167891|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.026||0.0224|2-Sided|95.0|0.009|0.111||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720437|NCT00696020|3167891|Superiority or Other||Mean Difference (Final Values)|0.042|Standard Error of the Mean|0.026||0.1163|2-Sided|95.0|-0.01|0.093||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720438|NCT00696020|3167892|Superiority or Other||Mean Difference (Final Values)|0.057|Standard Error of the Mean|0.027||0.0337|2-Sided|95.0|0.004|0.11||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|10 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720439|NCT00696020|3167892|Superiority or Other||Mean Difference (Final Values)|0.033|Standard Error of the Mean|0.027||0.2133|2-Sided|95.0|-0.019|0.085||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|5 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720440|NCT00696020|3167892|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.027||0.3791|2-Sided|95.0|-0.029|0.076||Type I error was controlled by a closed stepwise procedure.|ANCOVA|terms for baseline, treatment, and centre (centre random, all other effects fixed).|2 µg Olodaterol + 5 µg Tiotropium minus 5 µg Tiotropium.||
1720441|NCT00695565|3167944|Superiority or Other||Mean Difference (Net)|-1.2||||0.014|2-Sided|95.0|||||Mixed Models Analysis|||"Each subject was screened for responsiveness of nociceptors in the skin to a capsaicin stimulus (rated on 0-10 pain scale; 0=no pain and 10=worst possible pain). The interaction term composed of treatment assignment and capsaicin threshold was examined at the prespecified alpha level of 0.1.~This analysis includes subjects with a capsaicin rating of ≥ 2. Thirty (30) subjects in the Placebo group and 33 subjects in the active Clonidine Topical Gel (ARC-4558) group had capsaicin scores ≥ 2."|
1720442|NCT00695565|3167944|Superiority or Other||Mean Difference (Net)|-0.5||||0.168|2-Sided|95.0|||||Mixed Models Analysis|||This analysis does not take into account the subjects' screening capsaicin response (measure of nociceptor function).|
1720443|NCT00695097|3167969|Superiority or Other|||||||0.62||||||P < 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (baseline) compared to post-treatment (follow-up) CD20 cell density|
1720444|NCT00695097|3167969|Superiority or Other|||||||0.054||||||P < 0.05 threshold of significance|t-test, 2 sided|||pretreatment (baseline) compared to post-treatment (follow-up) biopsy CD20 cell density|
1720445|NCT00695097|3167969|Superiority or Other|||||||0.46||||||P < 0.05 threshold of significance|t-test, 2 sided|||Pretreatment (Baseline) compared to post-treatment (follow-up) CD3 cell density|
1720448|NCT00695019|3167970|Superiority or Other|||||||0.03|||||||Chi-squared||||
1720449|NCT00695019|3167971|Superiority or Other|||||||0.21|||||||Kruskal-Wallis|||Fibrotest provides an estimate of liver fibrosis based on the values of 5 serum markers. Scores range from 0 to 1 with higher scores indicating a greater level of liver fibrosis. A negative change in Fibrotest score is therefore deemed to indicate improvement (reduction in fibrosis), while a positive change indicates worsening condition.|
1720450|NCT00695019|3167972|Superiority or Other|||||||0.0023||||||Analysis not adjusted to account for baseline differences between the groups.|Kruskal-Wallis||||
1720451|NCT00695019|3167973|Superiority or Other|||||||0.72|||||||Chi-squared||||
1720452|NCT00695019|3167974|Superiority or Other|||||||0.3|||||||Kruskal-Wallis||||
1720453|NCT00695019|3167975|Superiority or Other|||||||0.77|||||||Kruskal-Wallis||||
1720454|NCT00695019|3167976|Superiority or Other|||||||0.48|||||||Chi-squared||||
1720455|NCT00695019|3167977|Superiority or Other|||||||0.61|||||||Chi-squared||||
1720456|NCT00694707|3167978|Superiority or Other||Least squares mean difference|-0.8|||<|0.0001|2-Sided|95.0|-1.1|-0.6|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.|||
1720457|NCT00694707|3167978|Superiority or Other||Least squares mean difference|-0.6|||<|0.0001|2-Sided|95.0|-0.9|-0.4|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.|||
1720458|NCT00694707|3167978|Superiority or Other||Least squares mean difference|-0.5|||<|0.0003|2-Sided|95.0|-0.7|-0.2|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.|||
1720459|NCT00694707|3167978|Superiority or Other||Least squares mean difference|-0.4|||<|0.004|2-Sided|95.0|-0.6|-0.1|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline CGI-S score as the covariate.|||
1720460|NCT00694707|3167979|Superiority or Other||Least squares mean difference|-15.0|||<|0.0001|2-Sided|95.0|-19.4|-10.8|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.|||
1720461|NCT00694707|3167979|Superiority or Other||Least squares mean difference|-10.4|||<|0.0001|2-Sided|95.0|-14.6|-6.2|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.|||
1720462|NCT00694707|3167979|Superiority or Other||Least squares mean difference|-8.8|||<|0.0001|2-Sided|95.0|-13.1|-4.6|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.|||
1720463|NCT00694707|3167979|Superiority or Other||Least squares mean difference|-7.5|||<|0.0005|2-Sided|95.0|-11.8|-3.3|||ANCOVA|The analysis of covariance (ANCOVA) included treatment group and study center as factors and the Baseline PANSS total score as the covariate.|||
1720464|NCT00694564|3167983|Non-Inferiority or Equivalence|No power calculation was calculated as this was a pilot study to determine such parameters.||||||0.004|||||||MANOVA||||
1720465|NCT00694369|3167994|Superiority or Other|||||||0.007||||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.|||
1720466|NCT00694369|3167994|Superiority or Other|||||||0.014||||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.|||
1720467|NCT00694369|3167994|Superiority or Other|||||||0.161||||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used, and the nominal p-value for 90-mg dose comparison was not reported.|||
1720468|NCT00694369|3167994|Superiority or Other||||||<|0.001||||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)|||
1720469|NCT00694369|3167994|Superiority or Other||||||<|0.001||||||0.05 critical level was used.|stratified Wilcoxon rank sum test|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant).|||
1720470|NCT00694369|3167995|Superiority or Other||Difference in LS Means|6.75||||||95.0|4.53|8.97|||||Difference in LS Means (acetaminophen 2400 mg/codeine 240 mg minus placebo)||
1720471|NCT00694369|3167995|Superiority or Other||Difference in LS Means|10.59||||||95.0|8.72|12.47|||||Difference in LS Means (ibuprofen 2400 mg minus placebo)||
1720472|NCT00694369|3167995|Superiority or Other||Difference in LS Means|-0.38||||||95.0|-1.8|1.05|||||Difference in LS Means (etoricoxib 120 mg minus etoricoxib 90 mg)||
1720473|NCT00694369|3167995|Non-Inferiority or Equivalence|Non-inferiority bound (etoricoxib minus acetaminophen/codeine) is -2.41.|Difference in LS Means|4.27||||||95.0|2.61|5.94|||||Difference in LS Means (etoricoxib minus acetaminophen/codeine)||
1720474|NCT00694369|3167995|Non-Inferiority or Equivalence|Non-inferiority bound (etoricoxib minus cetaminophen/codeine) is -2.41.|Difference in LS Means|3.9||||||95.0|2.04|5.76|||||Difference in LS Means (etoricoxib minus acetaminophen/codeine)||
1720475|NCT00694369|3167995|Non-Inferiority or Equivalence|Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.|Difference in LS Means|0.43||||||95.0|-0.73|1.6|||||Difference in LS Means (etoricoxib minus ibuprofen)||
1720476|NCT00694369|3167995|Non-Inferiority or Equivalence|Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.|Difference in LS Means|0.06||||||95.0|-1.37|1.48|||||Difference in Least squares means (LS Means) (etoricoxib minus ibuprofen)||
1720477|NCT00694369|3167995|Superiority or Other||||||<|0.001||||||0.05 critical level was used.|ANOVA|Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)|||
1720478|NCT00694369|3167995|Superiority or Other||||||<|0.001||||||0.05 critical level was used.|ANOVA|"Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value~for 120-mg dose comparison is significant)."|||
1720479|NCT00694122|3168052|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1720480|NCT00694122|3168056|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1720547|NCT00692198|3168195|Superiority or Other|||||||0.73|||||||t-test, 2 sided||||
1720548|NCT00692198|3168196|Superiority or Other||Rate ratio|1.08||||0.12|2-Sided|95.0|0.98|1.19|||Fisher Exact||Rate ratio, LTOT vs No LTOT||
1720481|NCT00694122|3168057|Superiority or Other||Mean Difference (Final Values)|277.9|Standard Error of the Mean|164.9|<|0.05|2-Sided|95.0|-75.9|631.6|||t-test, 2 sided|No adjustments were made. T-test type: Paired samples t-test (df=14) was performed using 15 within subject differences.|The comparative measures was defined as (mean AUC of glargine (Lantus)) minus (mean AUC of NPH).||
1720482|NCT00694070|3168082|Non-Inferiority or Equivalence|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} < Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 90%, with n=51, critical number is 43. With this critical value and sample size, the power to reject Ho is approximately 93.57%."||||||0.0309|||||||Exact binomial test||||
1720483|NCT00694070|3168083|Non-Inferiority or Equivalence|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} < Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 95%, with n=51, critical number is 47. With this critical value and sample size, the power to reject Ho is approximately 88.96%."||||||0.0309|||||||Exact binomial test||||
1720484|NCT00694070|3168084|Non-Inferiority or Equivalence|"The null and alternative hypotheses for these tests will have the form:~Ho: Pr{Success} < Po vs. Ha: Pr{Success} ≥ Po. Critical values for numbers of successes were computed to give approximately a 90% chance of rejecting Ho in favor of the alternative (non-inferiority) if the true probability of success is at least Po. For Po = 80%, with n=51, critical number is 38. With this critical value and sample size, the power to reject Ho is approximately 87.43%."||||||0.0421|||||||Exact binomial test||||
1720485|NCT00693992|3168088|Superiority|||||||0.8393|||||||Fisher Exact||||
1720486|NCT00693992|3168089|Superiority|||||||0.0061|||||||Fisher Exact||||
1720487|NCT00693992|3168091|Superiority or Other||Hazard Ratio (HR)|0.98||||0.89|2-Sided|95.0|0.73|1.31|||Log Rank||||
1720488|NCT00693992|3168092|Superiority or Other||Hazard Ratio (HR)|0.62||||0.0006|2-Sided|95.0|0.47|0.82|||Log Rank||||
1720489|NCT00693498|3168112|Other|||||||0.29||||||for POD#2 assessment|Wald-Wolf||||
1720490|NCT00693498|3168112|Other||||||<|0.03||||||the reported value is for POD#1 assessment|Wald Wolfowitz||||
1720491|NCT00693303|3168132|Superiority or Other|||||||0.27|||||||t-test, 2 sided||||
1720492|NCT00693225|3168137|Superiority or Other|||||||1|||||||Fisher Exact||||
1720493|NCT00692913|3168142|Superiority or Other||Difference in Least Squares Mean|-8.07|||<|0.001||95.0|-11.94|-4.21|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|||
1720494|NCT00692913|3168143|Superiority or Other||Difference in Least Squares Means|-8.35||||0.001||95.0|-13.19|-3.54|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|||
1720495|NCT00692913|3168144|Superiority or Other||Difference of falls (falls/patient-year)|0.03|Standard Error of the Mean|0.08||0.675||95.0|-0.12|0.19|||Zero-Inflated Poisson Regression|Adjusted by the terms for treatment, baseline 25(OH) D level stratum, age, and region and offset variable of log (total patient-years in the study).|||
1720496|NCT00692913|3168145|Superiority or Other||Least Squares Mean Difference|0.82||||0.035||95.0|0.06|1.58|||Traditional Longitudinal data analysis|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|FOSAVANCE minus Referred-Care. Analysis was for Total Hip.||
1720497|NCT00692913|3168145|Superiority or Other||Least Squares Mean Difference|1.01||||0.047||95.0|0.01|2.0|||Traditional Longitudinal data analysis|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|FOSAVANCE minus Referred-Care. Analysis was for Lumbar Spine.||
1720498|NCT00692913|3168146|Superiority or Other||Odds Ratio (OR)|0.21|||<|0.001||95.0|0.13|0.35|||Regression, Logistic|The logistic regression model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|||
1720499|NCT00692913|3168147|Superiority or Other||Difference in Least-squares mean|-7.07|||<|0.001||95.0|-10.95|-3.2|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|||
1720500|NCT00692913|3168148|Superiority or Other||Difference in Least-squares means|-9.7|||<|0.001||95.0|-14.49|-4.93|||Longitudinal Data Analysis Model|The model was adjusted by baseline 25-hydroxyvitamin D level stratum, age, and region.|||
1720501|NCT00692913|3168149|Superiority or Other||Odds Ratio (OR)|0.2|||<|0.001||95.0|0.12|0.35|||Regression, Logistic|The logistic regression model was adjusted by baseline 25-hydroxyvitamin D (25(OH)D) level stratum, age, and region.|||
1720502|NCT00692770|3168150|Superiority or Other||Hazard Ratio (HR)|1.56|||||2-Sided|95.0|1.206|2.018|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.||
1720503|NCT00692770|3168151|Superiority or Other||Hazard Ratio (HR)|1.747|||||2-Sided|95.0|1.407|2.17|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.||
1720504|NCT00692770|3168152|Superiority or Other||Hazard Ratio (HR)|1.562|||||2-Sided|95.0|1.241|1.965|||||Significance of the biomarker main effect (RFS) and its corresponding hazard ratio estimate (HR) with 95% CI were reported. HR was expressed as high/low biomarker levels.||
1720505|NCT00692770|3168153|Superiority or Other||Mean Difference (Final Values)|2.5|||<|0.0001|2-Sided|95.0|1.4|3.6|||ANCOVA|||An ANCOVA model was used to estimate the mean difference in the timeadjusted AUC between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the FACT-G score. Statistical tests were performed with a 2 sided type I error of 5%.|
1720506|NCT00692770|3168154|Superiority or Other||Mean Difference (Final Values)|5.1|||<|0.0001|2-Sided|95.0|3.5|6.7|||ANCOVA|||An ANCOVA model was used to estimate the mean difference in the timeadjusted AUC between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the FACT-HEP score. Statistical tests were performed with a 2 sided type I error of 5%.|
1720549|NCT00692198|3168198|Superiority or Other||Rate ratio|1.01||||0.81|2-Sided|95.0|0.91|1.13|||Fisher Exact||Rate ratio, LTOT vs No LTOT||
1720507|NCT00692770|3168155|Superiority or Other||Mean Difference (Final Values)|2.978|||<|0.0001|2-Sided|95.0|1.797|4.159|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to estimate the mean difference in the timeadjusted Area Under Curve (AUC) between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the EQ-5D VAS score. Statistical tests were performed with a 2 sided type I error of 5%.|
1720508|NCT00692770|3168156|Superiority or Other||Mean Difference (Final Values)|0.039|||<|0.0001|2-Sided|95.0|0.025|0.052|||ANCOVA|||An analysis of covariance (ANCOVA) model was used to estimate the mean difference in the timeadjusted Area Under Curve (AUC) between the two treatment groups, with covariates for baseline scores and stratification factors. To test the treatment effect, a mixed linear model (random coefficient model) was used for the EQ-5D index score. Statistical tests were performed with a 2 sided type I error of 5%.|
1720509|NCT00692770|3168157|Superiority or Other||Hazard Ratio (HR)|0.995|||=|0|2-Sided|95.0|0.761|1.3||One-sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank||||
1720510|NCT00692770|3168158|Superiority or Other||Hazard Ratio (HR)|0.891|||=|0|2-Sided|95.0|0.735|1.081||One sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank||||
1720511|NCT00692770|3168159|Superiority or Other||Hazard Ratio (HR)|0.94|||=|0|2-Sided|95.0|0.78|1.134||One sided P-value was stratified by region, risk of recurrence and previous curative treatment.|Log Rank||||
1720512|NCT00692406|3168163|Superiority or Other||Mean Difference (Final Values)|0.121|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.|
1720513|NCT00692406|3168164|Superiority or Other||Mean Difference (Final Values)|-0.0372|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.|
1720514|NCT00692406|3168165|Superiority or Other||Mean Difference (Final Values)|0.0096|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.|
1720515|NCT00692406|3168166|Superiority or Other||Mean Difference (Final Values)|-0.0489|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.|
1720516|NCT00692406|3168167|Superiority or Other||Mean Difference (Final Values)|0.1432|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.|
1720517|NCT00692406|3168168|Superiority or Other||Mean Difference (Final Values)|-0.0253|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.|
1720518|NCT00692406|3168169|Superiority or Other||Mean Difference (Final Values)|0.1167|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.|
1720519|NCT00692406|3168170|Superiority or Other||Mean Difference (Final Values)|-0.0023|||<|0.001||95.0|||||ANOVA|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.|
1720520|NCT00692341|3168171|Superiority or Other||Ratio of adjusted geometric means|128.76|||||2-Sided|90.0|75.62|219.25||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Cmaxu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720521|NCT00692341|3168171|Superiority or Other||Ratio of adjusted geometric means|106.82|||||2-Sided|90.0|58.22|195.99||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed Cmaxu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720522|NCT00692341|3168172|Superiority or Other||Ratio of adjusted geometric means|200.6|||||2-Sided|90.0|106.68|377.2||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUClastu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720523|NCT00692341|3168172|Superiority or Other||Adjusted ratio of geometric means|111.65|||||2-Sided|90.0|54.35|229.37||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUClastu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720524|NCT00692341|3168173|Superiority or Other||Ratio of adjusted geometric means|196.92|||||2-Sided|90.0|105.23|368.49||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞)u of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720525|NCT00692341|3168173|Superiority or Other||Ratio of adjusted geometric means|109.38|||||2-Sided|90.0|53.54|223.47||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞)u of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720550|NCT00692198|3168199|Superiority or Other||Hazard Ratio (HR)|0.9||||0.53|2-Sided|95.0|0.64|1.25|||Log Rank||Hazard ratio, LTOT vs No LTOT||
1720764|NCT00689117|3168528|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1720526|NCT00692341|3168174|Superiority or Other||Ratio of adjusted geometric means|76.06|||||2-Sided|90.0|41.41|139.73||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Vzu/F of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720527|NCT00692341|3168174|Superiority or Other||Ratio of adjusted geometric means|103.09|||||2-Sided|90.0|51.53|206.22||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed Vzu/F of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720528|NCT00692341|3168175|Superiority or Other||Ratio of adjusted geometric means|50.78|||||2-Sided|90.0|27.14|95.03||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed CLu/F of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720529|NCT00692341|3168175|Superiority or Other||Ratio of adjusted geometric means|91.43|||||2-Sided|90.0|44.75|186.79||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed CLu/F of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720530|NCT00692341|3168176|Superiority or Other||Ratio of adjusted geometric means|100.86|||||2-Sided|90.0|55.58|183.02||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed fu of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720531|NCT00692341|3168176|Superiority or Other||Ratio of adjusted geometric means|73.78|||||2-Sided|90.0|37.4|145.56||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed fu of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720532|NCT00692341|3168181|Superiority or Other||Ratio of adjusted geometric means|198.9|||||2-Sided|90.0|98.47|401.74||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUClast of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720533|NCT00692341|3168181|Superiority or Other||Ratio of adjusted geometric means|78.14|||||2-Sided|90.0|38.68|157.82||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUClast of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720534|NCT00692341|3168182|Superiority or Other||Ratio of adjusted geometric means|195.25|||||2-Sided|90.0|99.49|383.18||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞) of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720535|NCT00692341|3168182|Superiority or Other||Ratio of adjusted geometric means|78.34|||||2-Sided|90.0|39.92|153.75||||||For mild hepatic impairment, ANOVA was used to compare natural log transformed AUC (0 - ∞) of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720536|NCT00692341|3168183|Superiority or Other||Ratio of adjusted geometric means|127.67|||||2-Sided|90.0|70.9|229.91||||||For moderate hepatic impairment, ANOVA was used to compare natural log transformed Cmax of axitinib (AG-013736) between the control group (normal hepatic function) and moderate hepatic impairment. The point estimates and CIs on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (moderate hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720537|NCT00692341|3168183|Superiority or Other||Ratio of adjusted geometric means|88.61|||||2-Sided|90.0|49.2|159.56||||||For mild hepatic impairment, analysis of variance (ANOVA) was used to compare natural log transformed Cmax of axitinib (AG-013736) between the control group (normal hepatic function) and mild hepatic impairment. The point estimates and confidence intervals (CIs) on the log-scale were back transformed to provide estimates of the ratio of adjusted geometric means (mild hepatic impairment/normal hepatic function) and 90% CIs for the ratios.|
1720538|NCT00692211|3168186|Superiority or Other||Odds Ratio (OR)|1.56||||0.01|2-Sided|95.0|1.04|2.32||Not adjusted for multiple comparisons, a priori threshold of 0.05|Regression, Logistic|||Study powered to detect 10% difference in proportion of screening adherence based on alpha of 0.05, beta 0.20.|
1720539|NCT00692198|3168187|Superiority or Other|||||||0.21|||||||t-test, 2 sided||||
1720540|NCT00692198|3168188|Superiority or Other|||||||0.37|||||||t-test, 2 sided||||
1720541|NCT00692198|3168189|Superiority or Other||Risk Ratio (RR)|2.09|||||2-Sided|95.0|0.54|8.0|||||Relative risk, LTOT vs No LTOT||
1720542|NCT00692198|3168190|Superiority or Other|||||||0.41|||||||t-test, 2 sided||||
1720543|NCT00692198|3168191|Superiority or Other|||||||0.28|||||||t-test, 2 sided||||
1720544|NCT00692198|3168192|Superiority or Other|||||||0.03|||||||t-test, 2 sided||||
1720545|NCT00692198|3168193|Superiority or Other|||||||0.71|||||||t-test, 2 sided||||
1720546|NCT00692198|3168194|Superiority or Other|||||||0.21|||||||t-test, 2 sided||||
1720552|NCT00691483|3168251|Superiority or Other||Odds Ratio (OR)|4.14|||<|0.0001|2-Sided|95.0|2.58|6.67||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value >0.05 was obtained.|
1720553|NCT00691483|3168252|Superiority or Other||Odds Ratio (OR)|4.12|||<|0.0001|2-Sided|95.0|2.58|6.58||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Week 24. Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value >0.05 was obtained.|
1720554|NCT00691483|3168252|Superiority or Other||Odds Ratio (OR)|5.66|||<|0.0001|2-Sided|95.0|3.66|8.75||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Week 12. Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value >0.05 was obtained.|
1720555|NCT00691483|3168253|Superiority or Other||Odds Ratio (OR)|4.91|||<|0.0001|2-Sided|95.0|2.96|8.13||A 0.05 level of significance without adjustment for multiplicity.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Statistical testing to be 2-sided and use a 0.05 level of significance. Confidence intervals to have a 95% confidence level. Statistical significance to be declared unless a p-value >0.05 was obtained.|
1720556|NCT00691483|3168254|Superiority or Other||Odds Ratio (OR)|4.45|||<|0.0001|2-Sided|95.0|2.62|7.55||To preserve the type I family-wise error rate of 0.05, a step-down procedure to be used for the analysis of CA for Week 9 through Week 12 and the CA for Week 9 through Week 24.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Sample size to be based on a continuity-corrected Chi-square 2-sided test with a 0.05 significance level and a 3:1 randomization ratio of Varenicline to placebo. 652 subjects to provide >=90% power to detect Varenicline versus placebo differences in primary and key secondary efficacy endpoints (assuming placebo CA rates of 0.24 [Weeks 9-12] and 0.18 [Weeks 9-24] and Varenicline CA rates of 0.46 [Weeks 9-12] and 0.31 [Weeks 9-24]) (odds ratio of >=2.67 [Weeks 9-12] and >=2.10 [Weeks 9-24]).|
1720557|NCT00691483|3168255|Superiority or Other||Odds Ratio (OR)|6.03|||<|0.0001|2-Sided|95.0|3.8|9.56||To preserve the type I family-wise error rate of 0.05, a step-down procedure to be used for the analysis of CA for Week 9 through Week 12 and the CA for Week 9 through Week 24.|Regression, Logistic|Model to include the main effects of treatment and pooled center.||Sample size to be based on a continuity-corrected Chi-square 2-sided test with a 0.05 significance level and a 3:1 randomization ratio of Varenicline to placebo. 652 subjects to provide >=90% power to detect Varenicline versus placebo differences in primary and key secondary efficacy endpoints (assuming placebo CA rates of 0.24 [Weeks 9-12] and 0.18 [Weeks 9-24] and Varenicline CA rates of 0.46 [Weeks 9-12] and 0.31 [Weeks 9-24]) (odds ratio of >=2.67 [Weeks 9-12] and >=2.10 [Weeks 9-24]).|
1720558|NCT00691132|3168273|Superiority or Other|||||||0.045|||||||Mixed Models Analysis||||
1720559|NCT00691132|3168273|Superiority or Other|||||||0.623|||||||Mixed Models Analysis||||
1720560|NCT00691132|3168273|Superiority or Other|||||||0.039|||||||Mixed Models Analysis||||
1720561|NCT00691132|3168274|Superiority or Other|||||||0.017|||||||ANOVA|||Total ITC|
1720562|NCT00691132|3168276|Superiority or Other|||||||0.005|||||||ANOVA|||Total ITC|
1720563|NCT00691132|3168277|Superiority or Other||Mean Difference (Final Values)|-7.7||||0.023|2-Sided|95.0|-13.8|-1.2|||Mixed Models Analysis|||% difference between Placebo and PEITC periods in the ratio of [pyridine-D4]Hydroxy acid : [pyridine-D4] total NNAL|
1720564|NCT00690820|3168329|Superiority or Other|||||||0.023|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1720565|NCT00690820|3168330|Superiority or Other|||||||0.003|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1720566|NCT00690820|3168331|Superiority or Other|||||||0.671|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1720567|NCT00690820|3168332|Superiority or Other||||||<|0.001|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1720568|NCT00690820|3168333|Superiority or Other||||||<|0.001|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1720569|NCT00690820|3168334|Superiority or Other||||||<|0.001|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1720570|NCT00690820|3168335|Superiority or Other||||||<|0.001|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1720571|NCT00690820|3168336|Superiority or Other||||||<|0.001|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1720572|NCT00690755|3168339|Superiority or Other|||||||0.001|||||||ANOVA||||
1720573|NCT00689936|3168429|Superiority or Other (legacy)||Odds Ratio (OR)|2.44||||0.07302|2-Sided|95.0|1.01|5.91|||Fisher Exact||||
1720574|NCT00689936|3168429|Superiority or Other (legacy)||Odds Ratio (OR)|0.46||||0.11041|2-Sided|95.0|0.19|1.14|||Fisher Exact||||
1720575|NCT00689936|3168429|Superiority or Other (legacy)||Odds Ratio (OR)|1.13||||0.82128|2-Sided|95.0|0.46|2.8|||Fisher Exact||||
1720576|NCT00689936|3168430|Superiority or Other (legacy)||Odds Ratio (OR)|1.9||||0.01936|2-Sided|95.0|1.13|3.19|||Fisher Exact||||
1720577|NCT00689936|3168430|Superiority or Other (legacy)||Odds Ratio (OR)|1.38||||0.31274|2-Sided|95.0|0.78|2.43|||Fisher Exact||||
1720765|NCT00689117|3168528|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1720579|NCT00689936|3168431|Superiority or Other (legacy)||Odds Ratio (OR)|1.84||||0.07321|2-Sided|95.0|0.96|3.55|||Fisher Exact||||
1720580|NCT00689936|3168431|Superiority or Other (legacy)||Odds Ratio (OR)|0.93||||0.86336|2-Sided|95.0|0.47|1.83|||Fisher Exact||||
1720581|NCT00689936|3168431|Superiority or Other (legacy)||Odds Ratio (OR)|1.7||||0.11152|2-Sided|95.0|0.91|3.21|||Fisher Exact||||
1720582|NCT00689936|3168432|Superiority or Other (legacy)||Odds Ratio (OR)|1.65||||0.02374|2-Sided|95.0|1.08|2.53|||Fisher Exact||||
1720583|NCT00689936|3168432|Superiority or Other (legacy)||Odds Ratio (OR)|1.01||||1|2-Sided|95.0|0.64|1.59|||Fisher Exact||||
1720584|NCT00689936|3168432|Superiority or Other (legacy)||Odds Ratio (OR)|1.68||||0.02134|2-Sided|95.0|1.08|2.59|||Fisher Exact||||
1720585|NCT00689936|3168433|Superiority or Other (legacy)||Odds Ratio (OR)|1.34||||0.04974|2-Sided|95.0|1.01|1.79|||Fisher Exact||||
1720586|NCT00689936|3168433|Superiority or Other (legacy)||Odds Ratio (OR)|0.76||||0.08836|2-Sided|95.0|0.56|1.03|||Fisher Exact||||
1720587|NCT00689936|3168433|Superiority or Other (legacy)||Odds Ratio (OR)|1.02||||0.93824|2-Sided|95.0|0.75|1.38|||Fisher Exact||||
1720588|NCT00689936|3168434|Superiority or Other (legacy)||Hazard Ratio (HR)|0.87||||0.05821|2-Sided|95.0|0.76|1.0||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.||
1720589|NCT00689936|3168434|Superiority or Other (legacy)||Hazard Ratio (HR)|0.71||||1e-05|2-Sided|95.0|0.61|0.83||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.||
1720590|NCT00689936|3168434|Superiority or Other (legacy)||Hazard Ratio (HR)|0.63|||<|1e-05|2-Sided|95.0|0.54|0.73||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.||
1720591|NCT00689936|3168435|Superiority or Other (legacy)||Hazard Ratio (HR)|0.88||||0.12333|2-Sided|95.0|0.75|1.03||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720592|NCT00689936|3168435|Superiority or Other (legacy)||Hazard Ratio (HR)|0.74||||0.00067|2-Sided|95.0|0.63|0.88||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720593|NCT00689936|3168435|Superiority or Other (legacy)||Hazard Ratio (HR)|0.66|||<|1e-05|2-Sided|95.0|0.56|0.78||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720594|NCT00689936|3168436|Superiority or Other (legacy)||Hazard Ratio (HR)|0.93||||0.27704|2-Sided|95.0|0.83|1.06||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720595|NCT00689936|3168436|Superiority or Other (legacy)||Hazard Ratio (HR)|0.81||||0.00126|2-Sided|95.0|0.72|0.92||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720596|NCT00689936|3168436|Superiority or Other (legacy)||Hazard Ratio (HR)|0.76||||2e-05|2-Sided|95.0|0.67|0.86||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720597|NCT00689936|3168437|Superiority or Other (legacy)||Hazard Ratio (HR)|0.95||||0.45973|2-Sided|95.0|0.84|1.08||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720598|NCT00689936|3168437|Superiority or Other (legacy)||Hazard Ratio (HR)|0.81||||0.00187|2-Sided|95.0|0.71|0.93||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720599|NCT00689936|3168437|Superiority or Other (legacy)||Hazard Ratio (HR)|0.77||||0.00012|2-Sided|95.0|0.68|0.88||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720600|NCT00689936|3168438|Superiority or Other (legacy)||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)||||
1720601|NCT00689936|3168438|Superiority or Other (legacy)||||||<|0.46987|||||||Wilcoxon (Mann-Whitney)||||
1720602|NCT00689936|3168438|Superiority or Other (legacy)||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)||||
1720603|NCT00689936|3168439|Superiority or Other (legacy)||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)||||
1720604|NCT00689936|3168439|Superiority or Other (legacy)||||||<|0.46672|||||||Wilcoxon (Mann-Whitney)||||
1720605|NCT00689936|3168439|Superiority or Other (legacy)||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)||||
1720606|NCT00689936|3168440|Superiority or Other (legacy)||Hazard Ratio (HR)|1.0||||0.99537|2-Sided|95.0|0.85|1.17||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720607|NCT00689936|3168440|Superiority or Other (legacy)||Hazard Ratio (HR)|0.61|||<|1e-05|2-Sided|95.0|0.52|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720608|NCT00689936|3168440|Superiority or Other (legacy)||Hazard Ratio (HR)|0.61|||<|1e-05|2-Sided|95.0|0.51|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720609|NCT00689936|3168441|Superiority or Other (legacy)||Hazard Ratio (HR)|1.03||||0.7674|2-Sided|95.0|0.86|1.23||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.||
1720610|NCT00689936|3168441|Superiority or Other (legacy)||Hazard Ratio (HR)|0.6|||<|1e-05|2-Sided|95.0|0.5|0.72||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.||
1720611|NCT00689936|3168441|Superiority or Other (legacy)||Hazard Ratio (HR)|0.63|||<|1e-05|2-Sided|95.0|0.51|0.76||The p-value is based on the unstratified log-rank test.|Log Rank||Based on unstratified Cox proportional hazards model.||
1720612|NCT00689936|3168442|Superiority or Other (legacy)||Odds Ratio (OR)|1.77||||4e-05|2-Sided|95.0|1.35|2.32|||Fisher Exact||||
1720613|NCT00689936|3168442|Superiority or Other (legacy)||Odds Ratio (OR)|1.14||||0.405|2-Sided|95.0|0.85|1.54|||Fisher Exact||||
1720614|NCT00689936|3168442|Superiority or Other (legacy)||Odds Ratio (OR)|2.02|||<|1e-05|2-Sided|95.0|1.53|2.68|||Fisher Exact||||
1720615|NCT00689936|3168443|Superiority or Other (legacy)||Odds Ratio (OR)|1.67||||0.0001|2-Sided|95.0|1.29|2.15|||Fisher Exact||||
1720616|NCT00689936|3168443|Superiority or Other (legacy)||Odds Ratio (OR)|1.1||||0.53065|2-Sided|95.0|0.83|1.44|||Fisher Exact||||
1720617|NCT00689936|3168443|Superiority or Other (legacy)||Odds Ratio (OR)|1.83|||<|1e-05|2-Sided|95.0|1.41|2.37|||Fisher Exact||||
1720618|NCT00689936|3168444|Superiority or Other (legacy)||Hazard Ratio (HR)|0.77||||0.00119|2-Sided|95.0|0.66|0.9||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720619|NCT00689936|3168444|Superiority or Other (legacy)||Hazard Ratio (HR)|1.02||||0.82903|2-Sided|95.0|0.86|1.2||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720620|NCT00689936|3168444|Superiority or Other (legacy)||Hazard Ratio (HR)|0.78||||0.00234|2-Sided|95.0|0.67|0.92||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720621|NCT00689936|3168445|Superiority or Other (legacy)||Hazard Ratio (HR)|0.99||||0.91161|2-Sided|95.0|0.86|1.14||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720622|NCT00689936|3168445|Superiority or Other (legacy)||Hazard Ratio (HR)|0.7|||<|1e-05|2-Sided|95.0|0.6|0.81||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720623|NCT00689936|3168445|Superiority or Other (legacy)||Hazard Ratio (HR)|0.69|||<|1e-05|2-Sided|95.0|0.59|0.79||The p-value is based on the unstratified log-rank test.|Log Rank||Based on a stratified Cox proportional hazards model||
1720624|NCT00689936|3168446|Superiority or Other (legacy)||Hazard Ratio (HR)|1.03||||0.70349|2-Sided|95.0|0.89|1.2||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.||
1720625|NCT00689936|3168446|Superiority or Other (legacy)||Hazard Ratio (HR)|0.7||||1e-05|2-Sided|95.0|0.6|0.82||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.||
1720626|NCT00689936|3168446|Superiority or Other (legacy)||Hazard Ratio (HR)|0.72||||6e-05|2-Sided|95.0|0.61|0.85||The p-value is based on the unstratified log-rank test.|Log Rank||Based on stratified Cox proportional hazards model comparing the hazard functions associated with treatment groups.||
1720627|NCT00689793|3168455|Superiority or Other||Mean Difference (Final Values)|3.0|Standard Deviation|3.0||0.05|2-Sided|95.0|0.0|6.0|||Regression, Linear|Aerobic capacity at 4 weeks : dependant variables. Group allocation and aerobic capacity at baseline : independant variable.|||
1720628|NCT00689793|3168456|Superiority or Other||Mean Difference (Final Values)|15.0|Standard Deviation|8.0|<|0.05|2-Sided|95.0|0.0|30.0|||Regression, Linear|Ferritin level at 4 weeks : dependant variable. Group allocation and ferritin level at baseline: independant variables.|||
1720629|NCT00689793|3168457|Superiority or Other||Mean Difference (Final Values)|3.0|Standard Deviation|6.5|<|0.05||95.0|0.0|10.0|||Regression, Linear|Hemoglobin value at four weeks : dependant variable. Group allocation and hemoglobin value at baseline : independant variables.|||
1720630|NCT00689793|3168458|Superiority or Other||Mean Difference (Final Values)|1.0|Standard Deviation|2.5||0.69|2-Sided|95.0|0.0|10.0||Significant level of treatment effect was set at p<0.05|Regression, Linear|Level of fatigue at four weeks:dependant variable. Group allocation and level of fatigue at baseline: independant variables.||The null hypothesis was that there was no difference in fatigue VAS scores between the treatment and placebo groups at 4 weeks|
1720631|NCT00689728|3168461|Superiority or Other|||||||0.019||||||p-value is for Immunoglobulin A change at week 16 (LOCF)|ANCOVA||||
1720632|NCT00689728|3168461|Superiority or Other|||||||0.115||||||p-value is for Immunoglobulin A change at week 16 (LOCF)|ANCOVA||||
1720633|NCT00689728|3168461|Superiority or Other|||||||0.005||||||p-value is for Immunoglobulin M change at week 16 (LOCF)|ANCOVA||||
1720634|NCT00689728|3168461|Superiority or Other||||||<|0.001||||||p-value is for Immunoglobulin M change at week 16 (LOCF)|ANCOVA||||
1720635|NCT00689728|3168461|Superiority or Other||||||<|0.125||||||p-value is for Immunoglobulin G change at week 16 (LOCF)|ANCOVA||||
1720636|NCT00689728|3168461|Superiority or Other||||||<|0.146||||||p-value is for Immunoglobulin G change at week 16 (LOCF)|ANCOVA||||
1720637|NCT00689728|3168462|Superiority or Other|||||||0.015|||||||ANCOVA||||
1720638|NCT00689728|3168462|Superiority or Other|||||||0.001|||||||ANCOVA||||
1720639|NCT00689728|3168463|Superiority or Other|||||||0.056|||||||ANCOVA||||
1720640|NCT00689728|3168463|Superiority or Other|||||||0.01|||||||ANCOVA||||
1720641|NCT00689728|3168464|Superiority or Other||Mean Difference (Final Values)|7.7||||0.066||95.0|||||ANCOVA||||
1720642|NCT00689728|3168464|Superiority or Other||Mean Difference (Final Values)|2.6||||0.818||95.0|||||ANCOVA||||
1720643|NCT00689728|3168465|Superiority or Other|||||||0.016||||||p-value represents comparison of LY2127399-80 mg dose versus placebo for the 3 levels of EULAR response (good response, moderate response, no response).|Fisher Exact||||
1720644|NCT00689728|3168465|Superiority or Other|||||||0.022||||||p-value represents comparison of LY2127399-30 mg dose versus placebo for the 3 levels of EULAR response (good response, moderate response, no response).|Fisher Exact||||
1720645|NCT00689728|3168466|Superiority or Other||Mean Difference (Final Values)|-1.322||||0.005||95.0|||||ANCOVA||||
1720646|NCT00689728|3168466|Superiority or Other||Mean Difference (Final Values)|-0.912||||0.1||95.0|||||ANCOVA||||
1720647|NCT00689728|3168467|Superiority or Other|||||||0.92|||||||ANCOVA||||
1720648|NCT00689728|3168467|Superiority or Other|||||||0.554|||||||ANCOVA||||
1720649|NCT00689728|3168468|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.452||95.0|||||ANCOVA||||
1720650|NCT00689728|3168468|Superiority or Other||Mean Difference (Final Values)|-0.172||||0.969||95.0|||||ANCOVA||||
1720651|NCT00689728|3168469|Superiority or Other||Mean Difference (Final Values)|-19.1||||0.147||95.0|||||ANCOVA||||
1720652|NCT00689728|3168469|Superiority or Other||Mean Difference (Final Values)|-19.4||||0.11||95.0|||||ANCOVA||||
1720653|NCT00689728|3168470|Superiority or Other||Mean Difference (Final Values)|-25.6||||0.025||95.0|||||ANCOVA||||
1720654|NCT00689728|3168470|Superiority or Other||Mean Difference (Final Values)|-19.3||||0.157||95.0|||||ANCOVA||||
1720655|NCT00689728|3168471|Superiority or Other||Mean Difference (Final Values)|-19.3||||0.075||95.0|||||ANCOVA||||
1720656|NCT00689728|3168471|Superiority or Other||Mean Difference (Final Values)|-16.2||||0.168||95.0|||||ANCOVA||||
1720657|NCT00689728|3168472|Superiority or Other||Mean Difference (Final Values)|-5.3||||0.006||95.0|||||ANCOVA||||
1720658|NCT00689728|3168472|Superiority or Other||Mean Difference (Final Values)|-2.7||||0.403||95.0|||||ANCOVA||||
1720659|NCT00689728|3168473|Superiority or Other||Mean Difference (Final Values)|-6.6||||0.038||95.0|||||ANCOVA||||
1720660|NCT00689728|3168473|Superiority or Other||Mean Difference (Final Values)|-4.5||||0.337||95.0|||||ANCOVA||||
1720661|NCT00689728|3168474|Superiority or Other|||||||0.444|||||||Fisher Exact||||
1720662|NCT00689728|3168474|Superiority or Other|||||||0.5|||||||Fisher Exact||||
1720663|NCT00689728|3168475|Superiority or Other|||||||0.218|||||||Fisher Exact||||
1720664|NCT00689728|3168475|Superiority or Other|||||||0.281|||||||Fisher Exact||||
1720665|NCT00689728|3168476|Superiority or Other||Mean Difference (Final Values)|4.264||||0.173||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 80 mg. vs. placebo in Mental Health Component scores.|ANCOVA||||
1720666|NCT00689728|3168476|Superiority or Other||Mean Difference (Final Values)|1.72||||0.655||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 30 mg. vs. placebo in Mental Health Component scores.|ANCOVA||||
1720667|NCT00689728|3168476|Superiority or Other||Mean Difference (Final Values)|5.427||||0.052||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 80 mg. vs. placebo in Physical Health Component scores.|ANCOVA||||
1720668|NCT00689728|3168476|Superiority or Other||Mean Difference (Final Values)|4.873||||0.062||95.0||||p-value represents change from baseline at 16 weeks for LY2127399 30 mg. vs. placebo in Physical Health Component scores.|ANCOVA||||
1720669|NCT00689728|3168478|Superiority or Other|||||||0.116|||||||Fisher Exact||||
1720670|NCT00689728|3168478|Superiority or Other|||||||0.178|||||||Fisher Exact||||
1720671|NCT00689481|3168481|Superiority or Other|||||||0.015|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had moderate disease at baseline|
1720672|NCT00689481|3168481|Superiority or Other|||||||0.859|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had mild disease at baseline|
1720673|NCT00689481|3168482|Superiority or Other|||||||0.033|||||||Cochran-Mantel-Haenszel|Stratified by pooled center|||
1720674|NCT00689481|3168483|Superiority or Other|||||||0.052|||||||Cochran-Mantel-Haenszel|Stratified by pooled center|||
1720675|NCT00689481|3168484|Superiority or Other|||||||0.004||||||P-value is significant based on the Holm stepwise closed testing procedure to control multiplicity for the key secondary analyses if primary analysis was significant.|Cochran-Mantel-Haenszel|Stratified by pooled center.|||
1720676|NCT00689481|3168485|Superiority or Other|||||||0.034|||||||Cochran-Mantel-Haenszel|Stratified by pooled center|||
1720677|NCT00689481|3168486|Superiority or Other|||||||0.843|||||||Breslow-Day test|Breslow-Day test of the homogeneity of the odds ratio using a 0.1 significance level.||Consistency of results across investigative centers was verified using the Breslow-Day test of homogeneity the odds ration using a significance level of 0.1|
1720678|NCT00689481|3168486|Superiority or Other|||||||0.016|||||||Cochran-Mantel-Haenszel|Stratified by pooled center|||
1720679|NCT00689351|3168492|Superiority or Other|||||||0.138|||||||Fisher Exact|||Comparison between treatments for decreased sleep.|
1720680|NCT00689351|3168492|Superiority or Other|||||||0.613|||||||Fisher Exact|||Comparison between treatments for increased sleep.|
1720681|NCT00689351|3168492|Superiority or Other|||||||0.439|||||||Fisher Exact|||Comparison between treatments for irritability.|
1720682|NCT00689351|3168492|Superiority or Other|||||||0.663|||||||Fisher Exact|||Comparison between treatments for decreased appetite.|
1720683|NCT00689351|3168492|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for fever >39 degrees C but ≤40 degrees C.|
1720684|NCT00689351|3168492|Superiority or Other||||||>|0.596|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.|
1720685|NCT00689351|3168493|Superiority or Other|||||||0.125|||||||Fisher Exact|||Comparison between treatments for decreased sleep.|
1720686|NCT00689351|3168493|Superiority or Other|||||||0.398|||||||Fisher Exact|||Comparison between treatments for increased sleep.|
1720687|NCT00689351|3168493|Superiority or Other|||||||0.019|||||||Fisher Exact|||Comparison between treatments for irritability.|
1720688|NCT00689351|3168493|Superiority or Other|||||||0.535|||||||Fisher Exact|||Comparison between treatments for decreased appetite.|
1720689|NCT00689351|3168493|Superiority or Other|||||||0.468|||||||Fisher Exact|||Comparison between treatments for fever >39 degrees C but ≤40 degrees C.|
1720690|NCT00689351|3168493|Superiority or Other|||||||0.563|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.|
1720691|NCT00689351|3168494|Superiority or Other|||||||0.264|||||||Fisher Exact|||Comparison between treatments for decreased sleep.|
1720692|NCT00689351|3168494|Superiority or Other|||||||0.839|||||||Fisher Exact|||Comparison between treatments for increased sleep.|
1720693|NCT00689351|3168494|Superiority or Other|||||||0.159|||||||Fisher Exact|||Comparison between treatments for irritability.|
1720694|NCT00689351|3168494|Superiority or Other|||||||0.06|||||||Fisher Exact|||Comparison between treatments for decreased appetite.|
1720695|NCT00689351|3168494|Superiority or Other|||||||0.781|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.|
1720696|NCT00689351|3168495|Superiority or Other|||||||0.143|||||||Fisher Exact|||Comparison between treatments for decreased sleep.|
1720697|NCT00689351|3168495|Superiority or Other|||||||0.253|||||||Fisher Exact|||Comparison between treatments for increased sleep.|
1720698|NCT00689351|3168495|Superiority or Other|||||||0.009|||||||Fisher Exact|||Comparison between treatments for irritability.|
1720699|NCT00689351|3168495|Superiority or Other|||||||0.721|||||||Fisher Exact|||Comparison between treatments for decreased appetite.|
1720766|NCT00689117|3168528|Superiority or Other||||||<|0.002|||||||Cochran-Mantel-Haenszel||||
1720700|NCT00689351|3168495|Superiority or Other|||||||0.633|||||||Fisher Exact|||Comparison between treatments for fever ≥38 degrees C but but less than or equal to (≤)39 degrees C.|
1720701|NCT00689351|3168496|Superiority or Other|||||||0.2|||||||Fisher Exact|||Comparison between treatments for moderate redness.|
1720702|NCT00689351|3168496|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for mild redness.|
1720703|NCT00689351|3168496|Superiority or Other||||||>|0.506|||||||Fisher Exact|||Comparison between treatments for any redness.|
1720704|NCT00689351|3168496|Superiority or Other||||||>|0.495|||||||Fisher Exact|||Comparison between treatments for severe swelling.|
1720705|NCT00689351|3168496|Superiority or Other||||||>|0.144|||||||Fisher Exact|||Comparison between treatments for moderate swelling.|
1720706|NCT00689351|3168496|Superiority or Other||||||>|0.527|||||||Fisher Exact|||Comparison between treatments for mild swelling.|
1720707|NCT00689351|3168496|Superiority or Other||||||>|0.807|||||||Fisher Exact|||Comparison between treatments for any swelling.|
1720708|NCT00689351|3168496|Superiority or Other||||||>|0.617|||||||Fisher Exact|||Comparison between treatments for significant tenderness.|
1720709|NCT00689351|3168496|Superiority or Other||||||>|0.409|||||||Fisher Exact|||Comparison between treatments for any tenderness.|
1720710|NCT00689351|3168497|Superiority or Other|||||||0.331|||||||Fisher Exact|||Comparison between treatments for moderate redness.|
1720711|NCT00689351|3168497|Superiority or Other|||||||0.662|||||||Fisher Exact|||Comparison between treatments for mild redness.|
1720712|NCT00689351|3168497|Superiority or Other|||||||0.692|||||||Fisher Exact|||Comparison between treatments for any redness.|
1720713|NCT00689351|3168497|Superiority or Other|||||||0.533|||||||Fisher Exact|||Comparison between treatments for moderate swelling.|
1720714|NCT00689351|3168497|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for mild swelling.|
1720715|NCT00689351|3168497|Superiority or Other||||||>|0.683|||||||Fisher Exact|||Comparison between treatments for any swelling.|
1720716|NCT00689351|3168497|Superiority or Other||||||>|0.482|||||||Fisher Exact|||Comparison between treatments for significant tenderness.|
1720717|NCT00689351|3168497|Superiority or Other||||||>|0.681|||||||Fisher Exact|||Comparison between treatments for any tenderness.|
1720718|NCT00689351|3168498|Superiority or Other|||||||0.712|||||||Fisher Exact|||Comparison between treatments for moderate redness.|
1720719|NCT00689351|3168498|Superiority or Other|||||||0.451|||||||Fisher Exact|||Comparison between treatments for mild redness.|
1720720|NCT00689351|3168498|Superiority or Other|||||||0.578|||||||Fisher Exact|||Comparison between treatments for any redness.|
1720721|NCT00689351|3168498|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for moderate swelling.|
1720722|NCT00689351|3168498|Superiority or Other||||||>|0.684|||||||Fisher Exact|||Comparison between treatments for mild swelling.|
1720723|NCT00689351|3168498|Superiority or Other||||||>|0.447|||||||Fisher Exact|||Comparison between treatments for any swelling.|
1720724|NCT00689351|3168498|Superiority or Other||||||>|0.245|||||||Fisher Exact|||Comparison between treatments for significant tenderness.|
1720725|NCT00689351|3168498|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Comparison between treatments for any tenderness.|
1720726|NCT00689351|3168499|Superiority or Other|||||||0.718|||||||Fisher Exact|||Comparison between treatments for moderate redness.|
1720727|NCT00689351|3168499|Superiority or Other|||||||0.362|||||||Fisher Exact|||Comparison between treatments for mild redness.|
1720728|NCT00689351|3168499|Superiority or Other|||||||0.301|||||||Fisher Exact|||Comparison between treatments for any redness.|
1720729|NCT00689351|3168499|Superiority or Other|||||||0.366|||||||Fisher Exact|||Comparison between treatments for moderate swelling.|
1720730|NCT00689351|3168499|Superiority or Other|||||||0.052|||||||Fisher Exact|||Comparison between treatments for mild swelling.|
1720731|NCT00689351|3168499|Superiority or Other|||||||0.55|||||||Fisher Exact|||Comparison between treatments for any swelling.|
1720732|NCT00689351|3168499|Superiority or Other|||||||0.157|||||||Fisher Exact|||Comparison between treatments for significant tenderness.|
1720733|NCT00689351|3168499|Superiority or Other|||||||0.862|||||||Fisher Exact|||Comparison between treatments for any tenderness.|
1720734|NCT00689351|3168500|Superiority or Other||Ratio of geometric means|4.25|||||2-Sided|95.0|3.39|5.33|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)|
1720735|NCT00689351|3168500|Superiority or Other||Ratio of geometric means|110.92|||||2-Sided|95.0|77.09|159.59|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)|
1720736|NCT00689351|3168500|Superiority or Other||Ratio of geometric means|4.08|||||2-Sided|95.0|3.07|5.43|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)|
1720737|NCT00689351|3168500|Superiority or Other||Ratio of geometric means|6.84|||||2-Sided|95.0|5.39|8.67|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)|
1720738|NCT00689351|3168500|Superiority or Other||Ratio of geometric means|16.63|||||2-Sided|95.0|12.19|22.69|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)|
1720739|NCT00689351|3168500|Superiority or Other||Ratio of geometric means|234.33|||||2-Sided|95.0|176.33|311.41|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)|
1720767|NCT00689117|3168529|Superiority or Other|||||||0.002|||||||Cochran-Mantel-Haenszel||||
1720768|NCT00689117|3168529|Superiority or Other|||||||0.919|||||||Cochran-Mantel-Haenszel||||
1720740|NCT00689351|3168500|Superiority or Other||Ratio of geometric means|1.05|||||2-Sided|95.0|0.78|1.4|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)|
1720741|NCT00689351|3168500|Superiority or Other||Ratio of geometric means|1.45|||||2-Sided|95.0|1.11|1.88|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)|
1720742|NCT00689351|3168500|Superiority or Other||Ratio of geometric means|0.92|||||2-Sided|95.0|0.72|1.19|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)|
1720743|NCT00689351|3168500|Superiority or Other||Ratio of geometric means|0.74|||||2-Sided|95.0|0.57|0.95|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)|
1720744|NCT00689351|3168500|Superiority or Other||Ratio of geometric means|0.95|||||2-Sided|95.0|0.76|1.19|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)|
1720745|NCT00689351|3168500|Superiority or Other||Ratio of geometric means|1.11|||||2-Sided|95.0|0.83|1.48|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)|
1720746|NCT00689351|3168500|Superiority or Other||Ratio of geometric means|0.78|||||2-Sided|95.0|0.6|1.02|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)|
1720747|NCT00689351|3168501|Superiority or Other||Ratio of geometric means|2.24|||||2-Sided|95.0|1.83|2.75|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)|
1720748|NCT00689351|3168501|Superiority or Other||Ratio of geometric means|165.9|||||2-Sided|95.0|122.95|223.85|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)|
1720749|NCT00689351|3168501|Superiority or Other||Ratio of geometric means|9.01|||||2-Sided|95.0|6.46|12.56|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)|
1720750|NCT00689351|3168501|Superiority or Other||Ratio of geometric means|13.12|||||2-Sided|95.0|9.92|17.34|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)|
1720751|NCT00689351|3168501|Superiority or Other||Ratio of geometric means|40.79|||||2-Sided|95.0|30.27|54.97|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)|
1720752|NCT00689351|3168501|Superiority or Other||Ratio of geometric means|329.44|||||2-Sided|95.0|242.98|446.67|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)|
1720753|NCT00689351|3168501|Superiority or Other||Ratio of geometric means|1.04|||||2-Sided|95.0|0.8|1.36|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)|
1720754|NCT00689351|3168501|Superiority or Other||Ratio of geometric means|0.92|||||2-Sided|95.0|0.71|1.19|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)|
1720755|NCT00689351|3168501|Superiority or Other||Ratio of geometric means|0.97|||||2-Sided|95.0|0.79|1.18|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)|
1720756|NCT00689351|3168501|Superiority or Other||Ratio of geometric means|0.91|||||2-Sided|95.0|0.7|1.19|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)|
1720757|NCT00689351|3168501|Superiority or Other||Ratio of geometric means|0.88|||||2-Sided|95.0|0.73|1.07|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)|
1720758|NCT00689351|3168501|Superiority or Other||Ratio of geometric means|1.17|||||2-Sided|95.0|0.87|1.57|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)|
1720759|NCT00689351|3168501|Superiority or Other||Ratio of geometric means|0.77|||||2-Sided|95.0|0.62|0.97|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)|
1720760|NCT00689338|3168505|Superiority or Other||estimate of survival|53.8|||||2-Sided|95.0|45.9|60.9||||||Kaplan-Meier estimate of survival at Day 90 (survivor function).|
1720761|NCT00689299|3168511|Superiority or Other||||||<|0.05|||||||ANOVA|||ANOVA with baseline score as covariate|
1720762|NCT00689260|3168515|Superiority or Other|||||||0.908|||||||Wilcoxon (Mann-Whitney)|||P-Value based on two-sided Wilcoxon rank-sum test for difference in medians between log aware and log unaware|
1720763|NCT00689221|3168527|Superiority or Other||Hazard Ratio (HR)|1.021||||0.8623|2-Sided|95.0|0.808|1.291||P-value is not adjusted for multiple testing.|Log Rank||||
1720770|NCT00689117|3168530|Superiority or Other||||||<|0.001||||||Total lesion count|Ranked ANCOVA||||
1720771|NCT00689117|3168530|Superiority or Other||||||<|0.028||||||Total lesion count|Ranked ANCOVA||||
1720772|NCT00689117|3168530|Superiority or Other||||||<|0.001||||||Total lesion count|Ranked ANCOVA||||
1720773|NCT00689117|3168530|Superiority or Other||||||<|0.001||||||Non-inflammatory lesion count|Ranked ANCOVA||||
1720774|NCT00689117|3168530|Superiority or Other||||||<|0.284||||||Non-inflammatory lesion count|Ranked ANCOVA||||
1720775|NCT00689117|3168530|Superiority or Other||||||<|0.001||||||Non-inflammatory lesion count|Ranked ANCOVA||||
1720776|NCT00689117|3168530|Superiority or Other||||||<|0.001||||||Inflammatory lesion count|Ranked ANCOVA||||
1720777|NCT00689117|3168530|Superiority or Other||||||<|0.002||||||Inflammatory lesion count|Ranked ANCOVA||||
1720778|NCT00689117|3168530|Superiority or Other||||||<|0.065||||||Inflammatory lesion count|Ranked ANCOVA||||
1720779|NCT00689117|3168531|Superiority or Other||||||<|0.001||||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel||||
1720780|NCT00689117|3168531|Superiority or Other||||||<|0.001||||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel||||
1720781|NCT00689117|3168531|Superiority or Other||||||<|0.001||||||Data based on Data on File documenting FDA reanalysis request|Cochran-Mantel-Haenszel||||
1720782|NCT00689117|3168532|Superiority or Other||||||<|0.001||||||Total lesion count|Ranked ANCOVA||||
1720783|NCT00689117|3168532|Superiority or Other||||||<|0.016||||||Total lesion count|Ranked ANCOVA||||
1720784|NCT00689117|3168532|Superiority or Other||||||<|0.001||||||Total lesion count|Ranked ANCOVA||||
1720785|NCT00689117|3168532|Superiority or Other||||||<|0.001||||||Non-inflammatory lesion count|Ranked ANCOVA||||
1720786|NCT00689117|3168532|Superiority or Other||||||<|0.55||||||Non-inflammatory lesion count|Ranked ANCOVA||||
1720787|NCT00689117|3168532|Superiority or Other||||||<|0.004||||||Non-inflammatory lesion count|Ranked ANCOVA||||
1720788|NCT00689117|3168532|Superiority or Other||||||<|0.001||||||Inflammatory lesion count|Ranked ANCOVA||||
1720789|NCT00689117|3168532|Superiority or Other||||||<|0.003||||||Inflammatory lesion count|Ranked ANCOVA||||
1720790|NCT00689117|3168532|Superiority or Other||||||<|0.063||||||Inflammatory lesion count|Ranked ANCOVA||||
1720791|NCT00689104|3168559|Superiority or Other||LS Mean Difference|-0.33||||0.016|2-Sided|95.0|-0.6|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.|
1720792|NCT00689104|3168559|Superiority or Other||LS Mean Difference|-0.52|||<|0.001|2-Sided|95.0|-0.79|-0.26||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1720793|NCT00689104|3168559|Superiority or Other||LS mean Difference|-0.4|||<|0.004|2-Sided|95.0|-0.66|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1720794|NCT00689104|3168560|Superiority or Other||LS mean Difference|-0.35||||0.019|2-Sided|95.0|-0.68|-0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.|
1720795|NCT00689104|3168560|Superiority or Other||LS Mean Difference|-0.38||||0.002|2-Sided|95.0|-0.71|-0.05||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1720796|NCT00689104|3168560|Superiority or Other||LS Mean Difference|-0.39||||0.002|2-Sided|95.0|-0.71|-0.06||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1720814|NCT00688870|3168604|Superiority or Other|||||||0.726|||||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.|
1720815|NCT00688870|3168604|Superiority or Other|||||||0.61|||||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.|
1720797|NCT00689104|3168561|Superiority or Other||LS Mean Difference|12.6|||<|0.001|2-Sided|95.0|7.1|18.2||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.|
1720798|NCT00689104|3168561|Superiority or Other||LS Mean Difference|13.2|||<|0.001|2-Sided|95.0|7.7|18.7||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1720799|NCT00689104|3168561|Superiority or Other||LS Mean Difference|11.9|||<|0.001|2-Sided|95.0|6.3|17.4||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1720800|NCT00689104|3168562|Superiority or Other||LS Mean Difference|-0.25||||0.11|2-Sided|95.0|-0.55|0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.|
1720801|NCT00689104|3168562|Superiority or Other||LS Mean Difference|-0.44||||0.005|2-Sided|95.0|-0.74|-0.13||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1720802|NCT00689104|3168562|Superiority or Other||LS Mean Difference|-0.6|||<|0.001|2-Sided|95.0|-0.9|-0.29||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1720803|NCT00689104|3168563|Superiority or Other||LS Mean Difference|-0.1||||0.11|2-Sided|95.0|-0.42|0.21||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate||Since the comparison between tolterodine and placebo was a secondary analysis, no adjustment for multiplicity was necessary.|
1720804|NCT00689104|3168563|Superiority or Other||LS Mean Difference|-0.29||||0.01|2-Sided|95.0|-0.61|0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1720805|NCT00689104|3168563|Superiority or Other||LS Mean Difference|-0.41||||0.003|2-Sided|95.0|-0.72|-0.09||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1720806|NCT00688870|3168603|Superiority or Other|||||||0.525|||||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.|
1720807|NCT00688870|3168603|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.|
1720808|NCT00688870|3168603|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.|
1720809|NCT00688870|3168603|Superiority or Other||||||>|0.714|||||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.|
1720810|NCT00688870|3168603|Superiority or Other||||||>|||||||||||Fever >40 degrees C|
1720811|NCT00688870|3168603|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Fever >39 but <=40 degrees C, Fisher exact test was used to calculate p-value.|
1720812|NCT00688870|3168603|Superiority or Other||||||>|0.326|||||||Fisher Exact|||For Fever >=38 but <=39 degrees C, Fisher exact test was used to calculate p-value.|
1720813|NCT00688870|3168604|Superiority or Other|||||||0.855|||||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.|
1720816|NCT00688870|3168604|Superiority or Other|||||||0.322|||||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.|
1720817|NCT00688870|3168604|Superiority or Other|||||||0.496|||||||Fisher Exact|||For Fever >40 degrees C, Fisher exact test was used to calculate p-value.|
1720818|NCT00688870|3168604|Superiority or Other|||||||0.492|||||||Fisher Exact|||For Fever >39 but <=40 degrees C, Fisher exact test was used to calculate p-value.|
1720819|NCT00688870|3168604|Superiority or Other|||||||0.329|||||||Fisher Exact|||For Fever >=38 but <=39 degrees C, Fisher exact test was used to calculate p-value.|
1720820|NCT00688870|3168605|Superiority or Other|||||||0.237|||||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.|
1720821|NCT00688870|3168605|Superiority or Other|||||||0.868|||||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.|
1720822|NCT00688870|3168605|Superiority or Other|||||||0.872|||||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.|
1720823|NCT00688870|3168605|Superiority or Other|||||||0.522|||||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.|
1720824|NCT00688870|3168605|Superiority or Other|||||||||||||||||Fever >40 degrees C|
1720825|NCT00688870|3168605|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Fever >39 but <=40 degrees C, Fisher exact test was used to calculate p-value.|
1720826|NCT00688870|3168605|Superiority or Other||||||>|0.327|||||||Fisher Exact|||For Fever >=38 but <=39 degrees C, Fisher exact test was used to calculate p-value.|
1720827|NCT00688870|3168606|Superiority or Other|||||||0.748|||||||Fisher Exact|||For Decreased sleep, Fisher exact test was used to calculate p-value.|
1720828|NCT00688870|3168606|Superiority or Other|||||||0.753|||||||Fisher Exact|||For Increased sleep, Fisher exact test was used to calculate p-value.|
1720829|NCT00688870|3168606|Superiority or Other|||||||0.613|||||||Fisher Exact|||For Irritability, Fisher exact test was used to calculate p-value.|
1720830|NCT00688870|3168606|Superiority or Other|||||||0.527|||||||Fisher Exact|||For Decreased appetite, Fisher exact test was used to calculate p-value.|
1720831|NCT00688870|3168606|Superiority or Other|||||||||||||||||Fever >40 degrees C|
1720832|NCT00688870|3168606|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Fever >39 but <=40 degrees C, Fisher exact test was used to calculate p-value.|
1720833|NCT00688870|3168606|Superiority or Other||||||>|0.633|||||||Fisher Exact|||For Fever >=38 but <=39 degrees C, Fisher exact test was used to calculate p-value.|
1720834|NCT00688870|3168607|Superiority or Other|||||||||||||||||Redness - Severe|
1720835|NCT00688870|3168607|Superiority or Other|||||||0.477|||||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.|
1720836|NCT00688870|3168607|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.|
1720837|NCT00688870|3168607|Superiority or Other||||||>|0.805|||||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.|
1720838|NCT00688870|3168607|Superiority or Other||||||>|||||||||||Swelling - Severe|
1720839|NCT00688870|3168607|Superiority or Other||||||>|0.477|||||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.|
1720840|NCT00688870|3168607|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.|
1720841|NCT00688870|3168607|Superiority or Other||||||>|0.735|||||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.|
1720842|NCT00688870|3168607|Superiority or Other||||||>|||||||||||Tenderness - Significant|
1720843|NCT00688870|3168607|Superiority or Other||||||>|0.076|||||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.|
1720844|NCT00688870|3168608|Superiority or Other|||||||||||||||||Redness - Severe|
1720845|NCT00688870|3168608|Superiority or Other|||||||0.244|||||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.|
1720846|NCT00688870|3168608|Superiority or Other|||||||0.635|||||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.|
1720847|NCT00688870|3168608|Superiority or Other|||||||0.361|||||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.|
1720848|NCT00688870|3168608|Superiority or Other|||||||||||||||||Swelling - Severe|
1720849|NCT00688870|3168608|Superiority or Other|||||||0.496|||||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.|
1720850|NCT00688870|3168608|Superiority or Other|||||||0.076|||||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.|
1720851|NCT00688870|3168608|Superiority or Other|||||||0.044|||||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.|
1720852|NCT00688870|3168608|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.|
1720853|NCT00688870|3168608|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.|
1720854|NCT00688870|3168609|Superiority or Other|||||||||||||||||Redness - Severe|
1720855|NCT00688870|3168609|Superiority or Other|||||||0.497|||||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.|
1720856|NCT00688870|3168609|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.|
1720857|NCT00688870|3168609|Superiority or Other||||||>|0.674|||||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.|
1720858|NCT00688870|3168609|Superiority or Other||||||>|||||||||||Swelling - Severe|
1720859|NCT00688870|3168609|Superiority or Other||||||>|||||||||||Swelling - Moderate|
1720860|NCT00688870|3168609|Superiority or Other||||||>|0.81|||||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.|
1720861|NCT00688870|3168609|Superiority or Other||||||>|0.81|||||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.|
1720862|NCT00688870|3168609|Superiority or Other||||||>|0.617|||||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.|
1722325|NCT00667810|3171328|Superiority or Other|||||||0.567|||||||Log Rank||||
1720863|NCT00688870|3168609|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.|
1720864|NCT00688870|3168610|Superiority or Other|||||||||||||||||Redness - Severe|
1720865|NCT00688870|3168610|Superiority or Other|||||||0.275|||||||Fisher Exact|||For Redness - Moderate, Fisher exact test was used to calculate p-value.|
1720866|NCT00688870|3168610|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Redness - Mild, Fisher exact test was used to calculate p-value.|
1720867|NCT00688870|3168610|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Redness - Any, Fisher exact test was used to calculate p-value.|
1720868|NCT00688870|3168610|Superiority or Other||||||>|||||||||||Swelling - Severe|
1720869|NCT00688870|3168610|Superiority or Other||||||>|0.99|||||||Fisher Exact|||For Swelling - Moderate, Fisher exact test was used to calculate p-value.|
1720870|NCT00688870|3168610|Superiority or Other||||||>|0.059|||||||Fisher Exact|||For Swelling - Mild, Fisher exact test was used to calculate p-value.|
1720871|NCT00688870|3168610|Superiority or Other||||||>|0.039|||||||Fisher Exact|||For Swelling - Any, Fisher exact test was used to calculate p-value.|
1720872|NCT00688870|3168610|Superiority or Other||||||>|0.533|||||||Fisher Exact|||For Tenderness - Significant, Fisher exact test was used to calculate p-value.|
1720873|NCT00688870|3168610|Superiority or Other||||||>|0.735|||||||Fisher Exact|||For Tenderness - Any, Fisher exact test was used to calculate p-value.|
1720874|NCT00688870|3168611|Superiority or Other||ratio of GMCs|4.45|||||2-Sided|95.0|3.54|5.6|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 19A|
1720875|NCT00688870|3168611|Superiority or Other||ratio of GMCs|105.0|||||2-Sided|95.0|75.6|145.84|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 7F|
1720876|NCT00688870|3168611|Superiority or Other||ratio of GMCs|3.05|||||2-Sided|95.0|2.28|4.08|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 6A|
1720877|NCT00688870|3168611|Superiority or Other||ratio of GMCs|4.79|||||2-Sided|95.0|3.78|6.08|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 5|
1720878|NCT00688870|3168611|Superiority or Other||ratio of GMCs|10.65|||||2-Sided|95.0|7.77|14.62|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 3|
1720879|NCT00688870|3168611|Superiority or Other||ratio of GMCs|303.73|||||2-Sided|95.0|213.63|431.83|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 1|
1720880|NCT00688870|3168611|Superiority or Other||ratio of GMCs|0.69|||||2-Sided|95.0|0.52|0.92|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 23F|
1720881|NCT00688870|3168611|Superiority or Other||ratio of GMCs|1.09|||||2-Sided|95.0|0.83|1.43|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 19F|
1720882|NCT00688870|3168611|Superiority or Other||ratio of GMCs|0.75|||||2-Sided|95.0|0.57|0.99|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 14|
1720883|NCT00688870|3168611|Superiority or Other||ratio of GMCs|0.68|||||2-Sided|95.0|0.51|0.91|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 14|
1720884|NCT00688870|3168611|Superiority or Other||ratio of GMCs|0.82|||||2-Sided|95.0|0.64|1.05|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 9V|
1720885|NCT00688870|3168611|Superiority or Other||ratio of GMCs|1.03|||||2-Sided|95.0|0.77|1.36|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 6B|
1720886|NCT00688870|3168611|Superiority or Other||ratio of GMC|0.64|||||2-Sided|95.0|0.49|0.84|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 4|
1720887|NCT00688870|3168612|Superiority or Other||ratio of GMCs|1.5|||||2-Sided|95.0|1.23|1.83|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 19A|
1720888|NCT00688870|3168612|Superiority or Other||ratio of GMCs|96.1|||||2-Sided|95.0|75.6|122.17|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 7F|
1720889|NCT00688870|3168612|Superiority or Other||ratio of GMCs|5.82|||||2-Sided|95.0|4.42|7.67|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 6A|
1720987|NCT00687271|3168851|Other||Difference in Percentage Change|-12.2|||||2-Sided|95.0|-16.8|-7.6|||||||
1720890|NCT00688870|3168612|Superiority or Other||ratio of GMCs|5.69|||||2-Sided|95.0|4.37|7.41|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).||
1720891|NCT00688870|3168612|Superiority or Other||ratio of GMCs|24.11|||||2-Sided|95.0|18.46|31.49|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 3|
1720892|NCT00688870|3168612|Superiority or Other||ratio of GMCs|202.58|||||2-Sided|95.0|157.04|261.32|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Additional serotypes - serotype 1|
1720893|NCT00688870|3168612|Superiority or Other||ratio of GMCs|0.59|||||2-Sided|95.0|0.46|0.77|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 23F|
1720894|NCT00688870|3168612|Superiority or Other||ratio of GMCs|0.75|||||2-Sided|95.0|0.6|0.94|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 19F|
1720895|NCT00688870|3168612|Superiority or Other||ratio of GMCs|0.78|||||2-Sided|95.0|0.63|0.97|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 18C|
1720896|NCT00688870|3168612|Superiority or Other||ratio of GMCs|0.84|||||2-Sided|95.0|0.67|1.06|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 14|
1720897|NCT00688870|3168612|Superiority or Other||ratio of GMCs|0.67|||||2-Sided|95.0|0.55|0.82|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 9V|
1720898|NCT00688870|3168612|Superiority or Other||ratio of GMCs|0.91|||||2-Sided|95.0|0.7|1.17|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 6B|
1720899|NCT00688870|3168612|Superiority or Other||ratio of GMCs|0.62|||||2-Sided|95.0|0.5|0.78|||||Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).|Common serotypes - serotype 4|
1720900|NCT00688870|3168613|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|1.2|||||2-Sided|95.0|-3.4|6.5||||||Additional serotypes - serotype 19A|
1720901|NCT00688870|3168613|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|93.8|||||2-Sided|95.0|86.0|97.9||||||Additional serotypes - serotype 7F|
1720902|NCT00688870|3168613|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||2-Sided|95.0|-4.6|4.4||||||Additional serotypes - serotype 6A|
1720903|NCT00688870|3168613|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|9.6|||||2-Sided|95.0|3.8|18.1||||||Additional serotypes - serotype 5|
1720904|NCT00688870|3168613|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|82.5|||||2-Sided|95.0|72.0|90.1||||||Additional serotypes - serotype 3|
1720905|NCT00688870|3168613|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|95.0|||||2-Sided|95.0|87.7|98.6||||||Additional serotypes - serotype 1|
1720906|NCT00688870|3168613|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||2-Sided|95.0|-4.6|4.4||||||Common serotypes - serotype 23F|
1720907|NCT00688870|3168613|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||2-Sided|95.0|-6.9|3.1||||||Common serotypes - serotype 19F|
1720908|NCT00688870|3168613|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||2-Sided|95.0|-4.6|4.4||||||Common serotypes - serotype 18C|
1720909|NCT00688870|3168613|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||2-Sided|95.0|-4.6|4.4||||||Common serotypes - serotype 14|
1720910|NCT00688870|3168613|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||2-Sided|95.0|-6.9|3.1||||||Common serotypes - serotype 9V|
1720933|NCT00688740|3168630|Superiority or Other||Cox Proportional Hazard|0.742||||0.002|2-Sided|95.0|0.613|0.898||Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization|Log Rank||||
1720911|NCT00688870|3168613|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||2-Sided|95.0|-4.6|4.4||||||Common serotypes - serotype 6B|
1720912|NCT00688870|3168613|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.3|||||2-Sided|95.0|-6.9|3.1||||||Common serotypes - serotype 4|
1720913|NCT00688870|3168614|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||2-Sided|95.0|-4.6|4.5||||||Additional serotypes - serotype 19A|
1720914|NCT00688870|3168614|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|97.6|||||2-Sided|95.0|91.6|99.7||||||Additional serotypes - serotype 7F|
1720915|NCT00688870|3168614|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|22.9|||||2-Sided|95.0|14.4|33.4||||||Additional serotypes - serotype 6A|
1720916|NCT00688870|3168614|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|37.2|||||2-Sided|95.0|26.2|48.9||||||Additional serotypes - serotype 5|
1720917|NCT00688870|3168614|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|95.1|||||2-Sided|95.0|87.7|98.6||||||Additional serotypes - serotype 3|
1720918|NCT00688870|3168614|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|96.3|||||2-Sided|95.0|89.4|99.2||||||Additional serotypes - serotype 1|
1720919|NCT00688870|3168614|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-5.0|||||2-Sided|95.0|-12.3|-0.3||||||Common serotypes - serotype 23F|
1720920|NCT00688870|3168614|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||2-Sided|95.0|-6.8|3.3||||||Common serotypes - serotype 19F|
1720921|NCT00688870|3168614|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||2-Sided|95.0|-4.6|4.3||||||Common serotypes - serotype 18C|
1720922|NCT00688870|3168614|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||2-Sided|95.0|-4.6|4.3||||||Common serotypes - serotype 14|
1720923|NCT00688870|3168614|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||2-Sided|95.0|-6.8|3.3||||||Common serotypes - serotype 9V|
1720924|NCT00688870|3168614|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||2-Sided|95.0|-4.6|4.3||||||Common serotypes - serotype 6B|
1720925|NCT00688870|3168614|Non-Inferiority or Equivalence|Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.2|||||2-Sided|95.0|-6.8|3.3||||||Common serotypes - serotype 4|
1720926|NCT00688844|3168616|Superiority or Other||Mean Difference (Final Values)|0.131676|Standard Deviation|0.797247||0.3811|||||||t-test, 2 sided|||Objective was to evaluate dietary phenylalanine intake across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.|
1720927|NCT00688844|3168617|Superiority or Other||Mean Difference (Final Values)|-10.9549|Standard Deviation|20.10814||0.00088|||||||t-test, 2 sided|||Objective was to evaluate protein intake (grams per day) across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.|
1720928|NCT00688844|3168618|Superiority or Other||Mean Difference (Final Values)|-67.5187|Standard Deviation|362.9412||0.303864|||||||t-test, 2 sided|||Objective was to evaluate plasma phenylalanine across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.|
1720929|NCT00688844|3168619|Superiority or Other||Mean Difference (Final Values)|1.208889|Standard Deviation|3.51967||0.026009|||||||t-test, 2 sided|||Objective was to evaluate % fat mass across one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.|
1720930|NCT00688844|3168620|Superiority or Other||Mean Difference (Final Values)|2.419224|Standard Deviation|3.4666||0.017941|||||||t-test, 2 sided|||Objective was to evaluate % lean mass across one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.|
1720931|NCT00688844|3168621|Superiority or Other||Mean Difference (Final Values)|0.005401|Standard Deviation|0.0243|<|0.001|||||||t-test, 2 sided|||Objective was to evaluate total body bone mineral density (BMD) one year via DXA in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.|
1720932|NCT00688844|3168622|Superiority or Other||Mean Difference (Final Values)|-0.655574|Standard Deviation|8.060658||0.692782|||||||t-test, 2 sided|||Objective was to evaluate BMI across one year in PKU patients introduced to sapropterin after baseline. Study was prospective cohort in design.|
1720934|NCT00688740|3168631|Superiority or Other||Cox Proportional Hazard|0.795||||0.0043|2-Sided|95.0|0.679|0.932||Pairwise stratified log-rank test on the number of positive axillary nodes as per randomization|Log Rank||||
1720935|NCT00688701|3168641|Superiority or Other||LS mean difference|-0.66|Standard Error of the Mean|0.122|<|0.0001|2-Sided|95.0|-0.903|-0.423||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|||"To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.~Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (<8.0,>=8.0%), BMI (<30,>=30 kg/m^2), country as fixed effects, baseline HbA1c as covariate."|
1720936|NCT00688701|3168641|Superiority or Other||Least squares (LS) mean difference|-0.54|Standard Error of the Mean|0.123|<|0.0001|2-Sided|95.0|-0.785|-0.3||Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).|ANCOVA|||"To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.~Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (<8.0,>=8.0%), BMI (<30,>=30 kg/m^2), country as fixed effects, baseline HbA1c as covariate."|
1720937|NCT00688662|3168670|Superiority or Other||Risk Difference (RD)|-9.0|||||2-Sided|95.0|-24.1|5.9||||||Only patients with abnormal manometry were included in this subgroup analysis.|
1720938|NCT00688662|3168671|Superiority or Other||Risk Difference (RD)|-15.6||||0.01|2-Sided|95.0|-28.0|-3.3||The primary analysis was conducted using a logistic regression model with treatment group as the factor of interest and clinical center and PSH status as covariates. A Wald test using a two-tailed significance level of 0.0499 was conducted.|Regression, Logistic|Adjusted and unadjusted risk differences with two-sided 95% confidence intervals are reported in the manuscript.|The unadjusted risk difference and confidence interval was -14.3% (-27.3%, -1.2%).|The trial was designed to test for an overall absolute difference of at least 30% in the primary outcome (‘success’) in patients treated with sphincterotomy compared to those treated with sham. Using a 2:1 allocation, an assumed 10% non-adherence rate, and one interim analysis for efficacy using O’Brien and Fleming boundaries and futility using conditional power, the study required 214 patients to be randomized to ensure greater than 90% likelihood of identifying this difference.|
1720939|NCT00688636|3168676|Superiority or Other|||||||0.0005|||||||Fisher Exact||||
1720940|NCT00688519|3168689|Superiority or Other|||||||0.009|||||||Cochran-Mantel-Haenszel|stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had moderate disease at baseline|
1720941|NCT00688519|3168689|Superiority or Other|||||||0.167|||||||Cochran-Mantel-Haenszel|stratified by pooled center||Comparison of calcipotriene foam and vehicle foam for patients who had mild disease at baseline|
1720942|NCT00688519|3168690|Superiority or Other|||||||0.018|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.|
1720943|NCT00688519|3168691|Superiority or Other|||||||0.008|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.|
1720944|NCT00688519|3168692|Superiority or Other|||||||0.013|||||||Cochran-Mantel-Haenszel|Stratified by pooled center||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.|
1720945|NCT00688519|3168693|Superiority or Other|||||||0.029|||||||Cochran-Mantel-Haenszel|||These P-values are provided for information purposes only; they are considered non-significant (per the statistical analysis plan) because the analysis of the primary end point did not reach statistical significance.|
1720946|NCT00688519|3168694|Superiority or Other|||||||0.313|||||||Breslow-Day Test|Breslow-Day test of the homogeneity of the odds ratio using a 0.1 significance level.||Consistency of results across investigative centers was verified using the Breslow-Day test of homogeneity the odds ration using a significance level of 0.1|
1720947|NCT00688519|3168694|Superiority or Other|||||||0.058|||||||Cochran-Mantel-Haenszel|Stratified by pooled center|||
1720948|NCT00688467|3168703|Superiority or Other||100 * (placebo - navarixin) / placebo|4.3|Standard Deviation|7.398||0.645|||||||ANOVA||||
1720949|NCT00688467|3168704|Superiority or Other||100 * (placebo - navarixin) / placebo|-1.7|Standard Deviation|16.261||0.927|||||||ANOVA||||
1720950|NCT00688467|3168706|Superiority or Other||100 * (placebo - navarixin) / placebo|23.3|Standard Deviation|0.306||0.292|||||||ANOVA||||
1720951|NCT00688467|3168707|Superiority or Other||100 * (placebo - navarixin) / placebo|26.0|Standard Deviation|27.377||0.411|||||||ANOVA||||
1720952|NCT00688376|3168708|Superiority or Other (legacy)||LS mean difference|-0.2||||0.9075|2-Sided|95.0|-3.55|3.16|||ANCOVA|||Working Memory Scale Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.|
1720953|NCT00688376|3168708|Superiority or Other (legacy)||LS mean difference|1.7||||0.3155|2-Sided|95.0|-1.63|4.99|||ANCOVA|||Metacognition Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.|
1720954|NCT00688376|3168708|Superiority or Other (legacy)||LS mean difference|2.1||||0.2555|2-Sided|95.0|-1.54|5.69|||ANCOVA|||Behavioral Regulation Index Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.|
1720955|NCT00688376|3168708|Superiority or Other (legacy)||LS mean difference|1.7||||0.2886|2-Sided|95.0|-1.5|4.96|||ANCOVA|||Global Executive Composite Score Analysis. P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.|
1720956|NCT00688376|3168709|Superiority or Other (legacy)||LS mean difference|-0.4||||0.9088|2-Sided|95.0|-6.74|6.0|||ANCOVA|||RTSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.|
1720957|NCT00688376|3168709|Superiority or Other (legacy)||LS mean difference|2.5||||0.4385|2-Sided|95.0|-3.97|9.04|||ANCOVA|||RTSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.|
1720958|NCT00688376|3168709|Superiority or Other (legacy)||LS mean difference|0.2||||0.9561|2-Sided|95.0|-7.42|7.84|||ANCOVA|||RTVSS Change from Baseline to Week 12 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.|
1720959|NCT00688376|3168709|Superiority or Other (legacy)||LS mean difference|-1.4||||0.743|2-Sided|95.0|-9.56|6.85|||ANCOVA|||RTVSS Change from Baseline to Week 6 (LOCF). P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.|
1720960|NCT00688376|3168710|Superiority or Other (legacy)||LS mean difference|-0.1||||0.9458|2-Sided|95.0|-4.38|4.09|||ANCOVA|||P-values, LS mean, and 95% confidence intervals were obtained from ANCOVA model with treatment group as a factor and baseline value as covariate.|
1720961|NCT00688376|3168711|Superiority or Other (legacy)||LS mean difference|0.8||||0.694|2-Sided|95.0|-3.22|4.8|||ANCOVA|||P-values, least squares (LS) mean, and 95% confidence interval (CI) were obtained from Analysis of Covariance (ANCOVA) model with treatment group as a factor and Baseline value as covariate.|
1720962|NCT00688259|3168732|Superiority or Other|||||||0.001|||||||Mixed Models Analysis||||
1720963|NCT00688259|3168733|Superiority or Other|||||||0.001|||||||Mixed Models Analysis||||
1720964|NCT00688259|3168734|Superiority or Other|||||||0.02|||||||Mixed Models Analysis||||
1720965|NCT00688259|3168735|Superiority or Other|||||||0.23|||||||Mixed Models Analysis||||
1720966|NCT00688259|3168736|Superiority or Other|||||||0.01|||||||Mixed Models Analysis||||
1720967|NCT00688259|3168737|Superiority or Other|||||||0.01|||||||Mixed Models Analysis||||
1720968|NCT00688155|3168738|Equivalence|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|-0.16|Standard Error of the Mean|0.29||0.42|2-Sided||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training|
1720969|NCT00688155|3168738|Equivalence|Two-sided tests of marginal means|Mean Difference (Final Values)|0.26|Standard Error of the Mean|0.29||0.23|2-Sided||||||ANOVA|||Marginal comparisons of physical activity training versus no physical activity training.|
1720970|NCT00688155|3168740|Equivalence|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|0.07|Standard Error of the Mean|0.26||0.48|2-Sided||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training|
1720971|NCT00688155|3168740|Equivalence|Two Sided Test of Mean Difference from baseline|Mean Difference (Net)|0.02|Standard Error of the Mean|0.25||0.95|2-Sided||||||ANOVA|||Marginal comparisons of cognitive training versus no cognitive training|
1720972|NCT00688155|3168740|Equivalence|Two-sided tests of mean differences from baseline.|Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.26||0.55|2-Sided|||||P-value for physical activity training is 0.55|ANOVA|||Marginal comparisons of physical activity training versus no physical activity training|
1720973|NCT00688155|3168740|Equivalence|Two-sided test of mean differences from baseline.|Mean Difference (Net)|0.08|Standard Error of the Mean|0.25||0.66|2-Sided|||||Physical activity training versus no physical activity training;|ANOVA|||Marginal comparisons of physical activity training vs no physical activity training|
1720974|NCT00687830|3168767|Superiority or Other|||||||0.04|||||||Chi-squared||||
1720975|NCT00687830|3168768|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1720976|NCT00687739|3168782|Superiority||||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis compared the GnRHag+E2 and GnRHag+PL groups, pooled across exercise status. Differences in change over time between groups were tested by using an ANCOVA model, first with treatment group alone, and again adding FM and FFM to the model.|
1720977|NCT00687739|3168783|Superiority||||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis was the comparison of within-group changes in the E2 and placebo groups for cortisol AUC in response to Dex/CRH and between-group differences in the changes. Within-group changes and between-group differences in changes were evaluated by linear contrast using an ANCOVA model with adjustment for pre-intervention values of outcomes.|
1720978|NCT00687739|3168784|Superiority|The primary analysis compared the GnRHAG + E2 and GnRHAG + PL groups, pooled across exercise status. It was acknowledged that the inclusion of exercisers could minimize the effects of GnRHAG but would be reflective of the effects of ovarian hormone suppression on sedentary and active women. Differences in changes across time between groups were tested using an analysis of covariance model conditioned on baseline.|||||<|0.05||||||The p value was calculated|ANCOVA|||The primary analysis was the effect of PL vs E2 collapsed across exercise (2-group comparison). The analysis of effects of exercise was exploratory (evaluated within-group changes only).|
1720979|NCT00687297|3168845|Superiority or Other||Hazard Ratio (HR)|1.49||||0.02|2-Sided|95.0|1.07|2.07||p-value from Wald test|Regression, Cox|The model was adjusted for gender (male vs. female) and stage (Stage IIIB vs. Stage IV/Recurrent)||There was 80% power to detect a 50% improvement in median progression-free survival, using a stratified log-rank test with one-sided Type I error of 10%.|
1720980|NCT00687297|3168846|Superiority or Other||Mean Difference (Final Values)|0.5||||1||95.0|||||Fisher Exact|||Fisher's exact test with two-sided Type I error of 5% was used to test the null hypothesis of no difference in response rate between arms.|
1720981|NCT00687271|3168848|Other||Difference in Percentage Change|5.5|||||2-Sided|95.0|-4.6|16.9|||||||
1720982|NCT00687271|3168848|Other||Difference in Percentage Change|-1.0|||||2-Sided|95.0|-7.7|5.9|||||||
1720983|NCT00687271|3168849|Other||Difference in Percentage Change|-0.7|||||2-Sided|95.0|-5.8|4.4|||||||
1720984|NCT00687271|3168849|Other||Dfferecne in Percentage Change|-2.4|||||2-Sided|95.0|-6.6|1.8|||||||
1720985|NCT00687271|3168850|Other||Difference in Percentage Change|-11.0|||||2-Sided|95.0|-15.1|-7.0|||||||
1720986|NCT00687271|3168850|Other||Difference in Percentage Change|-7.4|||||2-Sided|95.0|-10.8|-4.1|||||||
1720988|NCT00687271|3168851|Other||Difference in Percentage Change|-7.7|||||2-Sided|95.0|-11.5|-3.9|||||||
1720989|NCT00687271|3168852|Other||Diffence in Percentage Change|-13.9|||||2-Sided|95.0|-18.9|-8.9|||||||
1720990|NCT00687271|3168852|Other||Difference in Percentage Change|-8.6|||||2-Sided|95.0|-12.7|-4.4|||||||
1720991|NCT00687271|3168855|Other||Difference in Percentage Change|-17.9|||||2-Sided|95.0|-23.4|-12.5|||||||
1720992|NCT00687271|3168855|Other||Difference in Percentage Change|-10.0|||||2-Sided|95.0|-14.6|-5.5|||||||
1720993|NCT00686959|3168899|Superiority or Other|||||||0.15|||||||Fisher Exact||||
1720994|NCT00686959|3168900|Superiority or Other|||||||0.457|||||||Fisher Exact|||Relapsed distant disease|
1720995|NCT00686959|3168900|Superiority or Other|||||||0.337|||||||Fisher Exact|||Relapsed inside thorax, outside of radiation field|
1720996|NCT00686959|3168900|Superiority or Other|||||||0.132|||||||Fisher Exact|||Relapsed within the radiation treatment field|
1720997|NCT00686959|3168903|Superiority or Other|||||||0.458|||||||Log Rank||||
1720998|NCT00686959|3168904|Superiority or Other||Hazard Ratio (HR)|0.86||||0.13|2-Sided|95.0|0.71|1.04|||Log Rank||||
1720999|NCT00686959|3168905|Superiority or Other||Hazard Ratio (HR)|0.98||||0.831|2-Sided|95.0|0.79|1.2|||Log Rank||||
1721000|NCT00686725|3168934|Superiority or Other|||||||0.915|||||||Log Rank||||
1721001|NCT00686725|3168935|Superiority or Other|||||||0.648|||||||Log Rank||||
1721002|NCT00686725|3168938|Superiority or Other|||||||0.35|||||||Log Rank||||
1721003|NCT00686725|3168939|Superiority or Other|||||||0.183|||||||Log Rank||||
1721004|NCT00686335|3169025|Superiority or Other||Mean Difference (Final Values)|-7.9|Standard Deviation|6.07|||2-Sided|95.0|-13.5|-2.2||||||As this was an explorative study to collect data for a subsequent controlled study, no hypothesis testing was performed. All analyses were descriptive.|
1721005|NCT00686205|3169036|Superiority or Other||Clinical Sensitivity|100.0||||||95.0|99.76|100.0|||||||
1721006|NCT00686205|3169037|Superiority or Other||Clinical Specificity|99.94||||||95.0|99.88|99.97|||||||
1721007|NCT00686166|3169040|Superiority or Other|||||||0.18|||||||Exact binomal test||||
1721008|NCT00685945|3169066|Superiority or Other||||||<|0.001|||||||ANOVA|Repeated measures ANOVA|||
1721009|NCT00685945|3169067|Superiority or Other|||||||0.04|||||||ANOVA|||The effect of bradykinin on net t-PA release was determined using general linear model-repeated measures ANOVA in which the between-subject variable was gender, and the within-subjects variables were drug (control, +L-NMMA, +L-NMMA plus isosorbide, or +L-NMMA plus sildenafil) and dose of bradykinin.|
1721010|NCT00685178|3169158|Superiority||Spearmann's rank correlation|0.494|||<|0.001|2-Sided||||||Generalized Estimating Equation (GEE)||NonCR subjects only|Analyses were performed to measure the correlation between Non-CR groups (topiramate + NonCR and Placebo + NonCR) and abstinence.|
1721011|NCT00685178|3169158|Superiority||Spearmann's rank correlation|0.969|||<|0.001|2-Sided||||||ANOVA||CR subjects only|Analyses were performed to measure the correlation between CR groups (topiramate + CR and Placebo + CR) and abstinence.|
1721012|NCT00685178|3169159|Superiority||F-value for main effect of Condition|2.21||||0.531|2-Sided|||||Using the proportion of negative urine samples obtained, the four groups were compared to determine whether there are any group differences in cocaine abstinence (as measured by negative urine samples).|Chi-squared||F-value for main effect of Drug Condition||
1721013|NCT00685035|3169168|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Deviation|0.23||0.02|2-Sided|95.0|||||ANCOVA||||
1721014|NCT00684983|3169176|Superiority||Hazard Ratio (HR)|0.39||||0.26|2-Sided|95.0|0.09|1.53|||Log Rank||||
1721015|NCT00684983|3169178|Superiority||Hazard Ratio (HR)|1.01||||0.66|2-Sided|95.0|0.53|1.92|||Log Rank||||
1721016|NCT00684983|3169179|Superiority||Hazard Ratio (HR)|1.22||||0.93|2-Sided|95.0|0.5|3.0|||Log Rank||||
1721017|NCT00684983|3169180|Superiority or Other (legacy)||Hazard Ratio (HR)|1.04||||0.89|2-Sided|95.0|0.58|1.89|||Regression, Cox|||Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.|
1721018|NCT00684788|3169184|Superiority||Odds Ratio (OR)|1.074||||0.959|2-Sided|95.0|0.071|16.245|||General Estimating Equation (GEE)||||
1721019|NCT00684788|3169186|Superiority||Odds Ratio (OR)|1.05||||0.939|2-Sided|95.0|0.32|3.42|||General Estimating Equation (GEE)||||
1721020|NCT00684788|3169189|Superiority|||||||0.0033|||||||t-test, 2 sided||||
1721021|NCT00684788|3169190|Superiority||Odds Ratio (OR)|5.68|||=|0|2-Sided|95.0|1.61|20.02|||General Estimating Equation (GEE)||||
1721022|NCT00684775|3169191|Superiority||Odds Ratio (OR)|1.82||||0.15|2-Sided|95.0|0.81|4.1|||General Estimating Equation (GEE)||||
1721023|NCT00684775|3169192|Superiority|||||||0.1543|||||||t-test, 2 sided||||
1721024|NCT00684775|3169193|Superiority||Odds Ratio (OR)|1.19||||0.75|2-Sided|95.0|0.42|3.36|||General Estimating Equation (GEE)||||
1721025|NCT00684775|3169194|Superiority||Odds Ratio (OR)|1.45|||=|0|2-Sided|95.0|0.6|3.53|||General Estimating Equation (GEE)||||
1721026|NCT00684775|3169195|Superiority||Odds Ratio (OR)|1.34||||0.56|2-Sided|95.0|0.5|3.6|||General Estimating Equation (GEE)||||
1721027|NCT00684775|3169196|Superiority|||||||0.0081|||||||t-test, 2 sided||||
1721028|NCT00684775|3169197|Superiority||Odds Ratio (OR)|6.0|||=|0|2-Sided|95.0|1.44|25.0|||General Estimating Equation (GEE)||||
1721029|NCT00684645|3169220|Superiority or Other||Hazard Ratio (HR)|0.361||||0.0221|2-Sided|95.0|0.151|0.864|||Cox proportional hazard|||Time to OS was analyzed using survival analysis methodology. Model was fitted with sunitinib-induced hypertension included as a time-dependent covariate (presence versus absence of hypertension).|
1721030|NCT00684645|3169221|Superiority or Other||Hazard Ratio (HR)|0.395|||<|0.0001|2-Sided|95.0|0.257|0.609|||Cox proportional hazard|||Time to PFS was analyzed using survival analysis methodology. Model was fitted with sunitinib-induced hypertension included as a time-dependent covariate (presence versus absence of hypertension).|
1721031|NCT00684424|3169260|Superiority or Other||R-ratio|-56.723|Standard Deviation|46.9499||||95.0||||||||R-ratio of seizure frequency summaries = [(t-b)/(t+b)]*100; where t= treatment seizure frequency and b= baseline seizure frequency.|
1721032|NCT00684177|3169304|Superiority or Other||Risk Difference (RD)|12.1||||0.04|2-Sided|95.0|0.6|23.6|||Chi-squared||||
1721033|NCT00684177|3169305|Superiority or Other||Risk Difference (RD)|12.1||||0.04|2-Sided|95.0|0.6|23.6|||Chi-squared||||
1721034|NCT00684177|3169306|Superiority or Other||Risk Difference (RD)|8.4||||0.098|2-Sided|95.0|-1.6|18.4|||Chi-squared||||
1721035|NCT00684073|3169312|Superiority or Other||Mean Difference (Net)|0.42||||0.13||95.0||||p-value adjusted for treatment only|ANCOVA||Difference between treatments (Suboxone minus Subutex)estimated by ANCOVA = 0.42.||
1721036|NCT00684060|3169313|Superiority or Other||Mean Difference (Net)|-2.6|Standard Error of the Mean|6.9|<|0.05||95.0|-6.0|0.8|||t-test, 2 sided|||Comparison of change in border zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results|
1721037|NCT00684060|3169314|Superiority or Other||Mean Difference (Net)|-0.7|Standard Error of the Mean|4.4|<|0.05|2-Sided|95.0|-2.8|1.3||Unadjusted|t-test, 2 sided|||Comparison of change in infarct zone wall motion in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results|
1721038|NCT00684060|3169315|Superiority or Other||Mean Difference (Net)|-1.5|Standard Error of the Mean|17.7|<|0.05||95.0|-9.9|6.9|||t-test, 2 sided|||Comparison of change in the active group minus change in the control group.|
1721039|NCT00684060|3169316|Superiority or Other||Mean Difference (Net)|2.5|Standard Error of the Mean|14.2|<|0.05|2-Sided|95.0|-4.1|9.2|||t-test, 2 sided|||Comparison of change in the active group minus change in the control group.|
1721040|NCT00684060|3169317|Superiority or Other||Mean Difference (Net)|0.7|Standard Error of the Mean|21.8|<|0.05|2-Sided|95.0|-9.5|10.9|||t-test, 2 sided|||Comparison of change in the active group minus change in global LVEF in the control group.|
1721041|NCT00684060|3169318|Superiority or Other||Mean Difference (Net)|-1.2|Standard Error of the Mean|17.2|<|0.05|2-Sided|95.0|-9.3|6.8|||t-test, 2 sided|||Comparison of change in the active group minus change in global LVEF in the control group.|
1721042|NCT00684060|3169319|Superiority or Other||Odds Ratio (OR)|0.3|||<|0.05||95.0|0.08|1.17|||Fisher Exact|||comparison of the proportion of events in patients in the active group to those in patients in the control group|
1721043|NCT00684060|3169320|Superiority or Other||Mean Difference (Net)|-3.0|Standard Error of the Mean|8.6|<|0.05|2-Sided|95.0|-7.05|0.95||Threshold 0.05|t-test, 2 sided|No adjustment for multiple comparisons||Comparison of change in global LVEF in the active group minus change in global LVEF in the control group. 80 percent power based on BOOST results|
1721044|NCT00684021|3169324|Superiority or Other||Mean Difference (Net)|-0.5|Standard Error of the Mean|1.7||0.777|2-Sided|95.0|-3.9|2.9|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.|||
1721045|NCT00684021|3169325|Superiority or Other||Mean Difference (Net)|100.0|Standard Error of the Mean|0.01||0.02|2-Sided|95.0|15.0|1000.0|||Regression, Linear||||
1721046|NCT00684021|3169325|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|1.1||0.409|2-Sided|95.0|-3.0|1.2|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.|||
1721047|NCT00684021|3169326|Superiority or Other||Mean Difference (Net)|-4.7|Standard Error of the Mean|4.27||0.272|2-Sided|95.0|-13.7|3.67|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.|
1721048|NCT00684021|3169327|Superiority or Other||Mean Difference (Net)|0.7|Standard Error of the Mean|3.7||0.817|2-Sided|95.0|-5.5|7.0|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.|
1721049|NCT00684021|3169328|Superiority or Other||Mean Difference (Net)|0.8|Standard Error of the Mean|3.7||0.831|2-Sided|95.0|-6.6|8.2|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.|
1721050|NCT00684021|3169329|Superiority or Other||Mean Difference (Net)|-2.6|Standard Error of the Mean|4.8||0.585|2-Sided|95.0|-12.2|6.9|||Regression, Linear|||Day 3 Stem Cell Arm and Day 7 Stem Cell Arm were combined and compared to the combination of Day 3 Placebo and Day 7 Placebo arms.|
1721051|NCT00684021|3169330|Superiority or Other||Risk Ratio (RR)|0.96||||0.93|2-Sided|95.0|0.42|2.23|||Fisher Exact|||Clinical and Safety Outcomes including death, reinfarction, repeat revascularization, hospitalization for heart failure and ICD placement. The relative incidences of events are compared between the active and placebo groups.However the paucity of events precluded a reliable time to event analysis.|
1721052|NCT00684021|3169331|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|2.0||0.959|2-Sided|95.0|-4.1|3.9|||t-test, 2 sided|Stem cell treatment arm combined (Day 3 and Day7); placebo group also combined.|||
1721053|NCT00683930|3169335|Superiority or Other||Treatment difference in response rate|5.1||||0.6558||97.5|-17.4|27.6|||Fisher Exact|Alpha = 0.025|||
1721054|NCT00683878|3169352|Superiority or Other||Mean Difference (Final Values)|-1.9|Standard Error of the Mean|0.4688|<|0.0001|2-Sided|95.0|-2.83|-0.98||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1721055|NCT00683878|3169352|Superiority or Other||Mean Difference (Final Values)|-1.58|Standard Error of the Mean|0.4838|<||2-Sided|95.0|-2.53|-0.62|||||||
1721056|NCT00683878|3169353|Superiority or Other||Mean Difference (Final Values)|-1.55|Standard Error of the Mean|0.5995||0.0101|2-Sided|95.0|-2.73|-0.37||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1721057|NCT00683878|3169353|Superiority or Other||Mean Difference (Final Values)|-0.85|Standard Error of the Mean|0.6006||0.1566|2-Sided|95.0|-2.03|0.33||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1721058|NCT00683878|3169354|Superiority or Other||Mean Difference (Final Values)|16.4|Standard Error of the Mean|5.253||0.0018|2-Sided|95.0|6.1|26.7||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression||||
1721059|NCT00683878|3169354|Superiority or Other||Mean Difference (Final Values)|10.1|Standard Error of the Mean|5.119||0.0496|2-Sided|95.0|0.0|20.1||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|Modified logistic regression||||
1722326|NCT00667810|3171328|Superiority or Other|||||||0.03||||||Not specifed.|Log Rank||||
1721060|NCT00683878|3169355|Superiority or Other||Mean Difference (Final Values)|-24.1|Standard Error of the Mean|4.082|<|0.0001|2-Sided|95.0|-32.2|-16.1||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1721061|NCT00683878|3169355|Superiority or Other||Mean Difference (Final Values)|-19.5|Standard Error of the Mean|4.088|<|0.0001|2-Sided|95.0|-27.5|-11.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1721062|NCT00683878|3169356|Superiority or Other||Mean Difference (Final Values)|-1.78|Standard Error of the Mean|0.3896|<|0.0001|2-Sided|95.0|-2.55|-1.02||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1721063|NCT00683878|3169356|Superiority or Other||Mean Difference (Final Values)|-1.55|Standard Error of the Mean|0.3896|<|0.0001|2-Sided|95.0|-2.32|-0.79||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1721064|NCT00683878|3169357|Superiority or Other||Mean Difference (Final Values)|-53.3|Standard Error of the Mean|9.039|<|0.0001|2-Sided|95.0|-71.1|-35.6||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1721065|NCT00683878|3169357|Superiority or Other||Mean Difference (Final Values)|-51.0|Standard Error of the Mean|9.007|<|0.0001|2-Sided|95.0|-68.7|-33.2||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05|ANCOVA||||
1721066|NCT00683878|3169358|Superiority or Other||Mean Difference (Final Values)|-0.55|Standard Error of the Mean|0.1175|<|0.0001|2-Sided|95.0|-0.78|-0.31||Primary endpoints were tested at alpha=0.027 applying Dunnett’s adjustment|ANCOVA||||
1721067|NCT00683878|3169358|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.1175|<|0.0007|2-Sided|95.0|-0.63|-0.17||Primary endpoints were tested at alpha=0.027 applying Dunnett’s adjustment|ANCOVA||||
1721068|NCT00683800|3169370|Superiority or Other||Wald Formula|0.08|||||2-Sided|90.0|-3.51|3.67|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.|
1721069|NCT00683800|3169371|Superiority or Other||Wald Formula|2.31|||||2-Sided|90.0|-2.08|6.71|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.|
1721070|NCT00683800|3169373|Superiority or Other||Wald Formula|1.11|||||2-Sided|90.0|-0.68|2.9|||||The 90% CI for excess risk is obtained using the Wald Formula.|Excess risk over placebo of DVS SR 100 mg per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.|
1721071|NCT00683800|3169374|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.|
1721072|NCT00683800|3169375|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.|
1721073|NCT00683800|3169376|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.|
1721074|NCT00683800|3169377|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.|
1721075|NCT00683800|3169378|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.|
1721076|NCT00683800|3169379|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.|
1721077|NCT00683800|3169380|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.|
1721078|NCT00683800|3169381|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.|
1721079|NCT00683800|3169382|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.|
1721080|NCT00683800|3169383|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.|
1721081|NCT00683800|3169384|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.|
1721082|NCT00683800|3169385|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel row mean score test was used to compare the treatment groups.|
1721083|NCT00683800|3169386|Superiority or Other||Adjusted Mean Difference|-0.45|||<|0.001|2-Sided|95.0|-0.61|-0.29|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721084|NCT00683800|3169386|Superiority or Other||Adjusted Mean Difference|-0.02|||<|0.865|2-Sided|95.0|-0.25|0.21|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721085|NCT00683800|3169386|Superiority or Other||Adjusted Mean Difference|-1.18|||<|0.001|2-Sided|95.0|-1.61|-0.75|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721137|NCT00683020|3169474|Non-Inferiority or Equivalence|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.6|Standard Error of the Mean|2.3||0.78|2-Sided|95.0|-3.8|5.1|||Regression, Linear|Adjusted for baseline values.|||
1722073|NCT00673660|3170655|Superiority or Other||||||<|0.001||||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||Total cholesterol|
1721086|NCT00683800|3169386|Superiority or Other||Adjusted Mean Difference|-0.08|||<|0.082|2-Sided|95.0|-0.17|0.01|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721087|NCT00683800|3169386|Superiority or Other||Adjusted Mean Difference|-0.62|||<|0.001|2-Sided|95.0|-0.83|-0.4|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721088|NCT00683800|3169386|Superiority or Other||Adjusted Mean Difference|-0.56|||<|0.001|2-Sided|95.0|-0.81|-0.3|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721089|NCT00683800|3169386|Superiority or Other||Adjusted Mean Difference|-1.71|||<|0.001|2-Sided|95.0|-2.42|-1.0|||Mixed Models Analysis|||For Month 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6 and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721090|NCT00683800|3169387|Superiority or Other||Adjusted Mean Difference|-0.41|||<|0.001|2-Sided|95.0|-0.56|-0.26|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721091|NCT00683800|3169387|Superiority or Other||Adjusted Mean Difference|-0.17|||<|0.14|2-Sided|95.0|-0.41|0.06|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721092|NCT00683800|3169387|Superiority or Other||Adjusted Mean Difference|-1.24|||<|0.001|2-Sided|95.0|-1.66|-0.82|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721093|NCT00683800|3169387|Superiority or Other||Adjusted Mean Difference|-0.04|||<|0.282|2-Sided|95.0|-0.13|0.04|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721094|NCT00683800|3169387|Superiority or Other||Adjusted Mean Difference|-0.58|||<|0.001|2-Sided|95.0|-0.8|-0.37|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721095|NCT00683800|3169387|Superiority or Other||Adjusted Mean Difference|-0.65|||<|0.001|2-Sided|95.0|-0.9|-0.41|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721096|NCT00683800|3169387|Superiority or Other||Adjusted Mean Difference|-1.87|||<|0.001|2-Sided|95.0|-2.57|-1.18|||Mixed Models Analysis|||For Month 6: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721097|NCT00683800|3169388|Superiority or Other||Adjusted Mean Difference|-0.64|||<|0.001|2-Sided|95.0|-0.79|-0.5|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Vasomotor scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721098|NCT00683800|3169388|Superiority or Other||Adjusted Mean Difference|-0.22|||<|0.066|2-Sided|95.0|-0.46|0.01|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Somatic scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721099|NCT00683800|3169388|Superiority or Other||Adjusted Mean Difference|-1.42|||<|0.001|2-Sided|95.0|-1.84|-1.0|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Psychological scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 was outcome variable, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1722535|NCT00666406|3171632|Superiority or Other||Ratio of the geometric means|1.182|||||2-Sided|90.0|1.029|1.359|||||||
1721100|NCT00683800|3169388|Superiority or Other||Adjusted Mean Difference|-0.05|||<|0.162|2-Sided|95.0|-0.13|0.02|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Sexual Dysfunction scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721101|NCT00683800|3169388|Superiority or Other||Adjusted Mean Difference|-0.67|||<|0.001|2-Sided|95.0|-0.89|-0.45|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Depression scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721102|NCT00683800|3169388|Superiority or Other||Adjusted Mean Difference|-0.75|||<|0.001|2-Sided|95.0|-0.99|-0.51|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Anxiety scale subscore was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721103|NCT00683800|3169388|Superiority or Other||Adjusted Mean Difference|-2.34|||<|0.001|2-Sided|95.0|-3.05|-1.64|||Mixed Models Analysis|||For Week 12: Change from baseline of the GCS Total score was analyzed using a Mixed-effects model repeated measures (MMRM), for which changes from baseline at week 12, month 6, and month 12 were outcome variables, with treatment, week, and interaction between treatment and week as fixed effects with participant as a random effect, and with the baseline score as covariate.|
1721104|NCT00683800|3169389|Superiority or Other||Adjusted Mean Difference|-0.33||||0.003|2-Sided|95.0|-0.54|-0.11|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)|
1721105|NCT00683800|3169389|Superiority or Other||Adjusted Mean Difference|-0.31||||0.002|2-Sided|95.0|-0.51|-0.12|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)|
1721106|NCT00683800|3169390|Superiority or Other||Adjusted Mean Difference|-2.81|||<|0.001|2-Sided|95.0|-4.12|-1.51|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 12)|
1721107|NCT00683800|3169390|Superiority or Other||Adjusted Mean Difference|-2.04|||<|0.001|2-Sided|95.0|-3.07|-1.0|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided). (At month 6)|
1721108|NCT00683800|3169391|Superiority or Other||||||<|0.001|||||||Log Rank|||A log-rank test was used to compare the treatment groups.|
1721109|NCT00683800|3169392|Superiority or Other||Odds Ratio (OR)|3.16|||<|0.001|2-Sided|95.0|1.96|5.09|||Regression, Logistic|||The proportion of participants achieving at least 75% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.|
1721110|NCT00683800|3169392|Superiority or Other||Odds Ratio (OR)|4.39|||<|0.001|2-Sided|95.0|2.47|7.81|||Regression, Logistic|||The proportion of participants achieving at least 75% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.|
1721111|NCT00683800|3169393|Superiority or Other||Odds Ratio (OR)|2.67|||<|0.001|2-Sided|95.0|1.75|4.1|||Regression, Logistic|||The proportion of participants achieving at least 50% hot flush reduction from baseline at 12-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.|
1721112|NCT00683800|3169393|Superiority or Other||Odds Ratio (OR)|3.47|||<|0.001|2-Sided|95.0|2.24|5.36|||Regression, Logistic|||The proportion of participants achieving at least 50% hot flush reduction from baseline at 4-week was compared between DVS and placebo treatment groups with a logistic regression model with treatment as factor and baseline value as a covariate.|
1721113|NCT00683800|3169394|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||The proportion of participants achieving a response as defined by minimal clinically important difference (MCID) at week 12 was compared between DVS and placebo treatment groups with a Cochran-Mantel-Haenszel test.|
1721114|NCT00683800|3169395|Superiority or Other||Wald Formula|-1.07|||||2-Sided|90.0|-2.86|0.72|||||The 90% CI for excess risk was obtained using the Wald Formula.|Excess risk of DVS SR 100 mg over placebo per 1000 woman-years of exposure, defined as the difference in the exposure adjusted rates between the treatment groups, was obtained.|
1721115|NCT00683800|3169396|Superiority or Other||Adjusted Mean Difference|-0.31|||<|0.001|2-Sided|95.0|-0.44|-0.18|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).|
1721116|NCT00683800|3169397|Superiority or Other||Adjusted Mean Difference|-0.28|||<|0.001|2-Sided|95.0|-0.4|-0.16|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).|
1721117|NCT00683800|3169398|Superiority or Other||Adjusted Mean Difference|-2.79|||<|0.001|2-Sided|95.0|-3.77|-1.82|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).|
1721118|NCT00683800|3169399|Superiority or Other||Adjusted Mean Difference|-2.89|||<|0.001|2-Sided|95.0|-3.8|-1.98|||ANCOVA|||An analysis of covariance with treatment as factor and baseline value as a covariate was used to compare DVS SR 100 mg with matching placebo. The comparison was performed at significance level of p=0.05 (two sided).|
1722536|NCT00666406|3171633|Superiority or Other||Ratio of the geometric means|1.152|||||2-Sided|90.0|1.039|1.277|||||||
1721119|NCT00683657|3169413|Superiority or Other||Mean Difference (Final Values)|-15.3|Standard Error of the Mean|4.0||0.0002|2-Sided|95.0|-23.3|-7.4||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.|
1721120|NCT00683657|3169414|Superiority or Other||Mean Difference (Final Values)|-18.7|Standard Error of the Mean|4.22|<|0.0001|2-Sided|95.0|-27.1|-10.3||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.|
1721121|NCT00683657|3169415|Superiority or Other||Mean Difference (Final Values)|-35.4|Standard Error of the Mean|10.41||0.001|2-Sided|95.0|-56.2|-14.7||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.|
1721122|NCT00683657|3169416|Superiority or Other||Mean Difference (Final Values)|-30.2|Standard Error of the Mean|7.1|<|0.0001|2-Sided|95.0|-44.4|-16.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA model: post - pre = pretreatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.|
1721123|NCT00683657|3169417|Superiority or Other||Mean Difference (Final Values)|-16.8|Standard Error of the Mean|4.16||0.0001|2-Sided|95.0|-25.1|-8.5||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|ANCOVA Model: post - pre = pre treatment|Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin.|With 39 subjects per treatment group, there was a 93% power for the primary endpoint to detect a difference in 24-hour mean weighted glucose of 16 mg/dL between saxagliptin and placebo, assuming a standard deviation of 20 mg/dL. Assuming a dropout rate of 15%, a total of 92 subjects (46 subjects per treatment arm) needed to be randomized.|
1721124|NCT00683644|3169418|Other|||||||0.93||||||Threshold for significance is 0.05|paired t test||||
1721125|NCT00683644|3169418|Other|||||||0.64||||||Threshold for significance is 0.05|paired t test||||
1721126|NCT00683644|3169419|Other|||||||0.36||||||Threshold for significance is 0.05|paired t test||||
1721127|NCT00683644|3169419|Other|||||||0.89||||||Threshold for significance is 0.05|paired t test||||
1721128|NCT00683644|3169420|Other|The observed power in THQ for zinc is 0.16, and that for placebo is 0.06.|||||>|0.05||||||Threshold for significance is 0.05|Chi-squared||||
1721129|NCT00683592|3169436|Superiority or Other||Risk Difference (RD)|0.069||||0.066|2-Sided|95.0|-0.008|0.147|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel tests were used to compare MADRS remission rates between the treatment groups, stratifying by center. The asymptotic confidence interval of the risk difference was estimated by the normal approximation to the binomial distribution.|
1721130|NCT00683592|3169437|Superiority or Other||Risk Difference (RD)|0.134||||0.002|2-Sided|95.0|0.047|0.221|||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel tests were used to compare MADRS response rates between the treatment groups, stratifying by center. The asymptotic confidence interval of the risk difference was estimated by the normal approximation to the binomial distribution.|
1721131|NCT00683592|3169438|Superiority or Other||Difference in Least Squares Mean Change|-1.2||||0.037|2-Sided|95.0|-2.4|-0.1|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline HAM-A total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.|
1721132|NCT00683592|3169439|Superiority or Other||Difference in Least Squares Mean Improve|-0.3||||0.004|2-Sided|95.0|-0.5|-0.1|||ANOVA|||The model was an analysis of variance (ANOVA), with terms for treatment group and center. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.|
1721133|NCT00683592|3169440|Superiority or Other||Difference in Least Squares Mean Change|-1.6||||0.026|2-Sided|95.0|-3.1|-0.2|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline HAM-D 17 total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.|
1721134|NCT00683592|3169441|Superiority or Other||Difference in Least Squares Mean Change|-2.5||||0.009|2-Sided|95.0|-4.4|-0.6|||ANCOVA|||The model was an analysis of covariance (ANCOVA), with terms for treatment group and center, adjusting for baseline MADRS total score. Missing values at week 8 were handled using the last observation carried forward (LOCF) approach.|
1721135|NCT00683163|3169467|Superiority or Other||Mean Difference (Net)|-1.2||||0.82|2-Sided|95.0|-11.5|9.2|||t-test, 2 sided|||Mean difference in percent change from baseline (Concurrent - Sequential)|
1721136|NCT00683020|3169473|Non-Inferiority or Equivalence|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.1|Standard Error of the Mean|1.4||0.13|2-Sided|95.0|-0.6|4.9|||Regression, Linear|Adjusted for baseline values.|||
1721138|NCT00683020|3169475|Non-Inferiority or Equivalence|Mean changes in comparison groups are not equal.|Mean Difference (Net)|-0.3|Standard Error of the Mean|0.2||0.13|2-Sided|95.0|-0.6|0.1|||Regression, Linear|Adjusted for baseline values.|||
1721139|NCT00683020|3169476|Non-Inferiority or Equivalence|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.0|Standard Error of the Mean|1.2||0.11|2-Sided|95.0|-0.4|4.4|||Regression, Linear|Adjusted for baseline values.|||
1721140|NCT00683020|3169477|Non-Inferiority or Equivalence|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.3|Standard Error of the Mean|2.2||0.54|2-Sided|95.0|-3.0|5.6|||Regression, Linear|Adjusted for baseline values.|||
1721141|NCT00683020|3169478|Non-Inferiority or Equivalence|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.1|Standard Error of the Mean|1.6||0.49|2-Sided|95.0|-2.1|4.2|||Regression, Linear|Adjusted for baseline values.|||
1721142|NCT00683020|3169479|Non-Inferiority or Equivalence|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.0|Standard Error of the Mean|0.1||0.87|2-Sided|95.0|-0.2|0.2|||Regression, Linear|Adjusted for baseline values.|||
1721143|NCT00683020|3169480|Non-Inferiority or Equivalence|Mean changes in comparison groups are not equal.|Mean Difference (Net)|0.3|Standard Error of the Mean|0.1||0.008|2-Sided|95.0|0.1|0.5|||Regression, Linear|Adjusted for baseline values.|||
1721144|NCT00683020|3169481|Non-Inferiority or Equivalence|Proportions in comparison groups are not equal.|Odds Ratio (OR)|0.5||||0.18|2-Sided|95.0|0.2|1.4|||Regression, Logistic|Adjusted for baseline values.|||
1721145|NCT00683020|3169482|Non-Inferiority or Equivalence|Days in comparison groups are not equal.|Rate Ratio|0.6||||0.25|2-Sided|95.0|0.3|1.4|||Negative Binomial Models|Adjusted for baseline values.|||
1721146|NCT00683020|3169483|Non-Inferiority or Equivalence|Mean changes in comparison groups are not equal.|Mean Difference (Net)|1.4|Standard Error of the Mean|1.2||0.23|2-Sided|95.0|-0.9|3.6|||Regression, Linear|Adjusted for baseline values.|||
1721147|NCT00683020|3169484|Non-Inferiority or Equivalence|Mean changes in comparison groups are not equal.|Mean Difference (Net)|2.0|Standard Error of the Mean|0.9||0.03|2-Sided|95.0|0.1|3.9|||Regression, Linear|Adjusted for baseline values.|||
1721148|NCT00682890|3169539|Superiority or Other|||||||0.03|||||||ANOVA||||
1721149|NCT00682890|3169539|Superiority or Other|||||||0.51|||||||ANOVA||||
1721150|NCT00682890|3169540|Superiority or Other|||||||0.42|||||||ANOVA||||
1721151|NCT00682890|3169540|Superiority or Other|||||||0.63|||||||ANOVA|||P value on change at 3 months for placebo group|
1721152|NCT00682838|3169545|Superiority or Other|||||||0.5|||||||t-test, 1 sided||||
1721153|NCT00682643|3169574|Superiority or Other|||||||0.342||||||Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value|Wald Chi-square||||
1721154|NCT00682643|3169575|Superiority or Other|||||||0.395||||||Wald Chi-Square test based on a proportional hazards model adjusting for age and baseline value|Wald Chi-square||||
1721155|NCT00681824|3169651|Superiority or Other|||||||0.7159|||||||likelihood ratio of chi squared test||||
1721156|NCT00681564|3169693|Superiority or Other|||||||0.43||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||"Statistical analysis: Brachial Artery Flow-mediated Dilation (12 weeks). Intention-to-treat analysis was not used because input of values for patients lost at follow-up will artificially amplify the precision of outcome measures.~Higgins JPT, Deeks JJ, Altman DG (editors). Chapter 16: Special topics in statistics. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.0.1. The Cochrane Collaboration, 2008. www.cochrane-handbook.org."|
1721157|NCT00681564|3169693|Superiority or Other|||||||0.005||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||Analyzed variable: Brachial Artery Flow-mediated Dilation (24 hours).|
1721158|NCT00681564|3169693|Superiority or Other|||||||0.98||||||A P value of 0.05 was used as a cut-off for statistical significance.|Kruskal-Wallis|Non-parametric test appropriate for the analysis of non-normally distributed data.||Analyzed variable: Brachial Artery Flow-mediated Dilation (baseline). Note: data analysis of patients who completed the study protocol (n=86). Intention-to-treat analysis analysis was not used because its application for the evaluation of continuous data would imply imputing missing data for patients lost to follow-up. Mean and standard deviation of flow-mediated dilatation, including data from all patients randomized in this study, is reported in the field of baseline characteristics.|
1721159|NCT00681538|3169694|Superiority or Other||Treatment Difference|-0.06||||0.9369|2-Sided|95.0|-1.62|1.49|||ANCOVA||A negative difference indicates an improvement in depression in favour of Sativex.||
1721160|NCT00681538|3169695|Superiority or Other||Treatment Difference|1.24||||0.5644|2-Sided|95.0|-3.01|5.5|||ANCOVA||A positive difference indicates an improvement in favour of Sativex.|Health Status VAS|
1721161|NCT00681538|3169695|Superiority or Other||Treatment Difference|0.02||||0.2836|2-Sided|95.0|-0.02|0.07|||ANCOVA||A positive difference indicates an improvement in favour of Sativex.|For Health State Index|
1721162|NCT00681538|3169696|Superiority or Other||Odds Ratio (OR)|1.958||||0.0045|2-Sided|95.0|1.232|3.112|||Regression, Logistic||An odds ratio > 1 indicates an improvement in favour of Sativex.||
1721163|NCT00681538|3169697|Superiority or Other||Odds Ratio (OR)|1.792||||0.0613|2-Sided|95.0|0.973|3.301|||Regression, Logistic||An odds ratio > 1 indicates an improvement in favour of Sativex.||
1721164|NCT00681538|3169698|Superiority or Other||Odds Ratio (OR)|2.4||||0.0053|2-Sided|95.0|1.297|4.443|||Regression, Logistic||An odds ratio > 1 indicates an improvement in favour of Sativex.||
1721165|NCT00681538|3169699|Superiority or Other||Odds Ratio (OR)|1.703||||0.0234|2-Sided|95.0|1.075|2.698|||Regression, Logistic||An odds ratio > 1 indicates an improvement in favour of Sativex.||
1721166|NCT00681538|3169700|Superiority or Other||Treatment difference|-3.34||||0.0687|2-Sided|95.0|-6.95|0.26|||ANCOVA||A negative treatment difference indicates an improvement in favour of Sativex.||
1721167|NCT00681538|3169701|Superiority or Other||Treatment difference|0.04||||0.98|2-Sided|95.0|-2.56|2.64|||ANCOVA||A positive treatment difference indicates an improvement in favour of Sativex.|For leg|
1722537|NCT00666406|3171634|Superiority or Other||Ratio of the geometric means|1.177|||||2-Sided|90.0|1.104|1.256|||||||
1721168|NCT00681538|3169701|Superiority or Other||treatment difference|-2.85||||0.56|2-Sided|95.0|-12.75|7.04|||ANCOVA||A positive treatment difference indicates an improvement in favour of Sativex.|For Arm|
1721169|NCT00681538|3169702|Superiority or Other||treatment difference|-1.75||||0.0939|2-Sided|95.0|-3.8|0.3|||ANCOVA||A negative difference indicates an improvement in spasticity in favour of Sativex.||
1721170|NCT00681538|3169703|Superiority or Other||treatment difference|-0.88|||<|0.0001|2-Sided|95.0|-1.25|-0.51|||ANCOVA||A negative difference indicates an improvement in sleep disruption in favour of Sativex.||
1721171|NCT00681538|3169704|Superiority or Other||Treatment difference|-2.53||||0.0046|2-Sided|95.0|-4.27|-0.79|||ANCOVA||A negative difference indicates an improvement in spasm frequency in favour of Sativex.||
1721172|NCT00681538|3169705|Superiority or Other||Odds Ratio (OR)|1.647||||0.0612|2-Sided|95.0|0.977|2.777|||Regression, Logistic||Odds ratio>1 indicates an improvement in favour of Sativex|50% Responders|
1721173|NCT00681538|3169705|Superiority or Other||Odds Ratio (OR)|2.731||||0.0003|2-Sided|95.0|1.589|4.694|||Regression, Logistic||Odds ratio>1 indicates an improvement in favour of Sativex|30% responders|
1721174|NCT00681538|3169706|Superiority or Other||Treatment Difference|-0.84||||0.0002|2-Sided|95.0|-1.29|-0.4|||ANCOVA||||
1721175|NCT00681031|3169737|Non-Inferiority or Equivalence|Acceptability was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) on the Geometric Mean Fold Rise (CMFR) from pre-vaccination to 4 weeks postvaccination is >1.4.|GMFR|3.1|||||2-Sided|95.0|2.6|3.8|||||GMFR = GMT postdose divided by GMT predose||
1721176|NCT00680953|3169743|Superiority or Other|||||||0.1568|||||||Log Rank||||
1721177|NCT00680953|3169744|Superiority or Other|||||||0.9951|||||||Log Rank||||
1721178|NCT00680953|3169745|Superiority or Other||Hazard Ratio (HR)|0.343||||0.0001|2-Sided|95.0|0.194|0.606|||Log Rank||||
1721179|NCT00680901|3169772|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.3244|2-Sided|95.0|0.74|1.1|||Log Rank|Stratified log-rank test was conducted stratifying for prior adjuvant/neo-adjuvant treatment use and region.|Pike estimator of HR was based on the stratified log rank test.||
1721180|NCT00680901|3169773|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.3492|2-Sided|95.0|0.73|1.12|||Log Rank|Stratified log-rank test was conducted stratifying for prior adjuvant/neo-adjuvant treatment use and region.|Pike estimator of HR was based on the stratified log rank test.||
1721181|NCT00680836|3169775|Superiority or Other||Mean Difference (Net)|0.0||||0.86|2-Sided|95.0|-0.5|0.6|||t-test, 2 sided||||
1721182|NCT00680836|3169776|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.72|2-Sided|95.0|-0.7|0.5|||t-test, 2 sided||||
1721183|NCT00680836|3169777|Superiority or Other||Mean Difference (Final Values)|0.0||||0.64|2-Sided|95.0|-0.2|0.2|||Chi-squared||||
1721184|NCT00680836|3169778|Superiority or Other||Mean Difference (Final Values)|0.1||||0.78|2-Sided|95.0|||||t-test, 2 sided||||
1721185|NCT00680836|3169779|Superiority or Other||Mean Difference (Final Values)|0.0||||0.98|2-Sided|95.0|0.0|0.5|||t-test, 2 sided||||
1721186|NCT00680836|3169780|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.26|2-Sided|95.0|-1.0|0.3|||t-test, 2 sided||||
1721187|NCT00680797|3169784|Superiority or Other|||||||0.042||||||Comparison in the change in insulin levels between the groups receiving E with or without T.|ANCOVA|||The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.|
1721188|NCT00680797|3169784|Superiority or Other|||||||0.023||||||Comparison of pre- to post-intervention insulin levels between the groups receiving E only versus the group receiving no hormone replacement.|ANCOVA|||The major outcome variable being presented is changes in insulin levels. Changes in insulin levels were analyzed using an ANCOVA model that adjusted for baseline insulin and age.|
1721189|NCT00680745|3169786|Superiority or Other||Mean Difference (Final Values)|-26.5|Standard Error of the Mean|3.545|<|0.0001|2-Sided|95.0|-33.5|-19.5||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1721190|NCT00680745|3169786|Superiority or Other||Mean Difference (Final Values)|-19.3|Standard Error of the Mean|3.594|<|0.0001|2-Sided|95.0|-26.3|-12.2||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1721191|NCT00680745|3169786|Superiority or Other||Mean Difference (Final Values)|-14.9|Standard Error of the Mean|3.522|<||2-Sided|95.0|-21.8|-7.9||||||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1721192|NCT00680745|3169787|Superiority or Other||Mean Difference (Final Values)|-1.67|Standard Error of the Mean|0.4211|<|0.0001|2-Sided|98.0|-2.5|-0.84||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1721193|NCT00680745|3169787|Superiority or Other||Mean Difference (Final Values)|-0.94|Standard Error of the Mean|0.4234|<|0.0262|2-Sided|95.0|-1.78|-0.11||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1721194|NCT00680745|3169787|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.4159|<||2-Sided|95.0|-1.19|0.45||||||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1721253|NCT00679432|3169928|Superiority or Other (legacy)||Difference in proportions|10.4||||0.0143|2-Sided|95.0|2.2|18.7|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|
1721195|NCT00680745|3169788|Superiority or Other||Risk Difference (RD)|18.7|Standard Error of the Mean|4.457|<|0.0001|2-Sided|95.0|9.9|27.4||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Based on methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0|
1721196|NCT00680745|3169788|Superiority or Other||Risk Difference (RD)|17.3|Standard Error of the Mean|4.392|<|0.0001|2-Sided|95.0|8.7|25.9||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Based on methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0|
1721197|NCT00680745|3169788|Superiority or Other||Risk Difference (RD)|13.7|Standard Error of the Mean|4.265|<||2-Sided|95.0|5.4|22.1||||||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0|
1721198|NCT00680745|3169789|Superiority or Other||Mean Difference (Final Values)|-28.9|Standard Error of the Mean|6.77|<|0.0001|2-Sided|95.0|-42.2|-15.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1721199|NCT00680745|3169789|Superiority or Other||Mean Difference (Final Values)|-26.0|Standard Error of the Mean|6.968|<|0.0002|2-Sided|95.0|-39.7|-12.3||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1721200|NCT00680745|3169789|Superiority or Other||Mean Difference (Final Values)|-31.5|Standard Error of the Mean|6.874|<||2-Sided|95.0|-45.0|-18.0||||||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1721201|NCT00680745|3169790|Superiority or Other||Mean Difference (Final Values)|-1.54|Standard Error of the Mean|0.3168|<|0.0001|2-Sided|95.0|-2.17|-0.92||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1721202|NCT00680745|3169790|Superiority or Other||Mean Difference (Final Values)|-0.84|Standard Error of the Mean|0.3217|<|0.0091|2-Sided|95.0|-1.47|-0.21||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1721203|NCT00680745|3169790|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.3153|<|0.141|2-Sided|95.0|-1.08|0.15||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1721204|NCT00680745|3169791|Superiority or Other||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|0.0873|<|0.0001|2-Sided|95.0|-0.86|-0.51||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided).|
1721205|NCT00680745|3169791|Superiority or Other||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.0885|<|0.0001|2-Sided|95.0|-0.67|-0.32||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided).|
1721206|NCT00680745|3169791|Superiority or Other||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|0.0867|<|0.0001|2-Sided|95.0|-0.61|-0.27||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group as effect (all treatment groups included) and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)|
1721207|NCT00680186|3169815|Superiority or Other||Hazard Ratio (HR)|0.67|||<|0.0001|2-Sided|95.0|0.56|0.81|||Regression, Cox||This is the analysis of the time to the first occurrence of any bleeding event.|HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of any bleeding was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1721208|NCT00680186|3169815|Superiority or Other||Hazard Ratio (HR)|0.69|||<|||95.0|0.36|1.32|||||This is the analysis of the time to the first MBE.|HR vs. Warfarin (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of MBE was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1721373|NCT00676715|3170267|Superiority or Other (legacy)|||||||0.474|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.|||
1721209|NCT00680186|3169816|Superiority or Other||Hazard Ratio (HR)|0.66||||0.3021|2-Sided|95.0|0.29|1.46|||Regression, Cox|||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1721210|NCT00680186|3169816|Superiority or Other||Risk Difference (Percentage)|-0.3||||0.321|2-Sided|95.0|-1.0|0.3|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic fatal and non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.|
1721211|NCT00680186|3169817|Superiority or Other||Hazard Ratio (HR)|1.04||||0.8939||95.0|0.61|1.77|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1721212|NCT00680186|3169817|Superiority or Other||Risk Difference (Percentage)|0.1||||0.7348||95.0|-0.7|1.0|||Kaplan Meier weighted estimates|||RD at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.|
1721213|NCT00680186|3169818|Superiority or Other||Risk Difference (Percentage)|0.2||||0.083||95.0|0.0|0.5|||Kaplan Meier weighted estimates|||RD at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.|
1721214|NCT00680186|3169819|Superiority or Other||Hazard Ratio (HR)|0.59||||0.2101||95.0|0.26|1.35|||Regression, Cox|||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1721215|NCT00680186|3169819|Superiority or Other||Risk Difference (Percentage)|-0.4||||0.2283||95.0|-1.1|0.3|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.|
1721216|NCT00680186|3169820|Superiority or Other||Hazard Ratio (HR)|1.65||||0.1054||95.0|0.9|3.01|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1721217|NCT00680186|3169820|Superiority or Other||Risk Difference (Percentage)|0.6||||0.1703||95.0|-0.3|1.5|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.|
1721218|NCT00680186|3169821|Superiority or Other||Hazard Ratio (HR)|1.09||||0.6383||95.0|0.75|1.6|||Regression, Cox|Patients without events are censored at the end of ptp.||HR vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1721219|NCT00680186|3169821|Superiority or Other||Risk Difference (Percentage)|0.3||||0.6932||95.0|-1.1|1.6|||Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall RD obtained based on the KM estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.|
1721220|NCT00680186|3169822|Superiority or Other||Hazard Ratio (HR)|1.08||||||95.0|0.64|1.8||||||HR vs. Warfarin (events occurring between randomisation and day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox PH model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE. This analysis was performed as sensitivity analysis for statistical analysis 1.|
1721221|NCT00680186|3169822|Non-Inferiority or Equivalence|Non inferiority margin was set up to 3.6% for the RD based on KM estimates|Risk Difference (Percentage)|0.2|||<|0.0001||95.0|-1.0|1.3||Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the RD (at day 180) and for the HR (events up to end of ptp) analyses to be reached in order to conclude positively on the primary endpoint.|Kaplan Meier weighted estimates|||RD vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall RD obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.|
1721222|NCT00680186|3169822|Non-Inferiority or Equivalence|Non inferiority margin was set up to 2.75 for the HR analysis|Hazard Ratio (HR)|1.13|||<|0.0002||95.0|0.69|1.85||Non-inferiority P-Value.Two co-primary analyses performed on primary endpoint. Both non inferiority for the risk difference (RD) (at day 180) and for the HR (up to end of ptp) analyses to be reached in order to conclude positively on primary endpoint|Regression, Cox|Patients without events are censored at the end of ptp.||Hazard ratio (HR) vs. Warfarin (events occurring between randomisation and end of ptp). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1721223|NCT00680056|3169827|Superiority or Other||Mean Difference (Net)|0.88|Standard Deviation|2.39||0.054||95.0|||||t-test, 2 sided||Mean difference=Arm 2 minus Arm 1||
1722538|NCT00666406|3171635|Superiority or Other||Ratio of the geometric means|0.915|||||2-Sided|90.0|0.841|0.995|||||||
1721224|NCT00680056|3169828|Superiority or Other||Mean Difference (Net)|56.0|Standard Deviation|60.0||0.038||95.0|||||t-test, 2 sided||Mean difference= Formoterol plus Tiotropium minus Formoterol plus Placebo(Tiotropium)|It was calculated a total sample size of a 2x2 cross-over design as 24 for a two-sided t-test achieves 85% power to infer that the mean difference is not zero, the actual mean difference is 20, the standard deviation of the differences is 15, and the significance level is 0.05|
1721225|NCT00680043|3169829|Superiority or Other||Risk Ratio (RR)|0.97|||||2-Sided|95.0|0.92|1.03|||||||
1721226|NCT00680043|3169829|Superiority or Other||Risk Ratio (RR)|0.92|||||2-Sided|95.0|0.84|1.01|||||||
1721227|NCT00680043|3169831|Superiority or Other||Least Squares Mean Difference|-0.02|Standard Error of the Mean|0.238|||2-Sided|97.5|-0.56|0.52|||||||
1721228|NCT00680043|3169831|Superiority or Other||Least Squares Mean Difference|-0.25|Standard Error of the Mean|0.238|||2-Sided|97.5|-0.79|0.29|||||||
1721229|NCT00680017|3169832|Superiority or Other||||||<|0.001||||||"P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as statistically significant. No adjustments made for multiple comparisons since only 1 secondary endpoint comparison."|ANCOVA|P-value obtained from an ANCOVA with corresponding baseline value as the covariate and an effect for treatment group.||The null hypothesis was that percent change in HDL-C from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in HDL-C from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 82% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in HDL-C.|
1721230|NCT00680017|3169833|Superiority or Other||||||<|0.001||||||"P values were based on 2 sided tests. Tests resulting in P values less than or equal to 0.050 (when rounded) were reported as statistically significant. No adjustments made for multiple comparisons since only 1 primary efficacy endpoint comparison."|Wilcoxon rank-sum test|||The null hypothesis was that percent change in triglycerides (TG) from baseline to Week 8 in the ABT-335 45 mg plus rosuvastatin 5 mg treatment group is equal to percent change in TG from baseline to Week 8 in the rosuvastatin 5 mg plus placebo treatment group. A sample size of 140 participants per treatment group was used to provide 98% power to detect a difference between the combination therapy arm and the rosuvastatin monotherapy arm in the percent change from Baseline to Week 8 in TG.|
1721231|NCT00679627|3169916|Superiority or Other|||||||0.137||||||Leisure subscale|ANCOVA||||
1721232|NCT00679627|3169916|Superiority or Other|||||||0.054||||||Instrumental subscale|ANCOVA||||
1721233|NCT00679627|3169916|Superiority or Other|||||||0.005||||||Basic subscale|ANCOVA||||
1721234|NCT00679627|3169916|Superiority or Other|||||||0.018||||||Effective Performance subscale|ANCOVA||||
1721235|NCT00679627|3169916|Superiority or Other|||||||0.043||||||Planning and Organization subscale|ANCOVA||||
1721236|NCT00679627|3169916|Superiority or Other|||||||0.01||||||Initiation subscale|ANCOVA||||
1721237|NCT00679627|3169917|Superiority or Other|||||||0.088||||||Language subscale|ANCOVA||||
1721238|NCT00679627|3169917|Superiority or Other|||||||0.158||||||Recall subscale|ANCOVA||||
1721239|NCT00679627|3169917|Superiority or Other|||||||0.009||||||Attention and Calculation subscale|ANCOVA||||
1721240|NCT00679627|3169917|Superiority or Other|||||||0.353||||||Registration subscale|ANCOVA||||
1721241|NCT00679627|3169917|Superiority or Other|||||||0.194||||||Orientation subscale|ANCOVA||||
1721242|NCT00679627|3169918|Superiority or Other|||||||0.835||||||Month 24|Cochran-Mantel-Haenszel||||
1721243|NCT00679627|3169918|Superiority or Other|||||||0.269||||||Baseline|Cochran-Mantel-Haenszel||||
1721244|NCT00679627|3169921|Superiority or Other|||||||0.002|||||||ANCOVA||||
1721245|NCT00679627|3169922|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1721246|NCT00679627|3169923|Superiority or Other||Hazard Ratio (HR)|0.58||||0.011|2-Sided|95.0|0.37|0.89|||Regression, Cox||||
1721247|NCT00679627|3169924|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1721248|NCT00679432|3169926|Superiority or Other (legacy)||Difference in proportions|0.0||||0.9991|2-Sided|95.0|-11.8|11.8|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Asacol and placebo groups is shown here.|
1721249|NCT00679432|3169927|Superiority or Other (legacy)||Difference in proportions|9.1||||0.1189|2-Sided|95.0|-2.3|20.4|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|
1721250|NCT00679432|3169927|Superiority or Other (legacy)||Difference in proportions|8.5||||0.142|2-Sided|95.0|-2.8|19.9|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|
1721251|NCT00679432|3169927|Superiority or Other (legacy)||Difference in proportions|5.8||||0.3146|2-Sided|95.0|-5.5|17.0|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.|
1721252|NCT00679432|3169928|Superiority or Other (legacy)||Difference in proportions|4.7||||0.22|2-Sided|95.0|-2.7|12.1|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|
1721374|NCT00676715|3170267|Superiority or Other (legacy)|||||||0.1596|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.|||
1721254|NCT00679432|3169928|Superiority or Other (legacy)||Difference in proportions|5.8||||0.1393|2-Sided|95.0|-1.8|13.4|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Asacol and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Asacol versus budesonide MMX.|
1721255|NCT00679380|3169929|Superiority or Other (legacy)||Difference in proportions|5.4||||0.4293|2-Sided|95.0|-8.0|18.8|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Entocort EC and placebo groups is shown here.|
1721256|NCT00679380|3169930|Superiority or Other (legacy)||Difference in proportions|-0.7||||0.9185|2-Sided|95.0|-14.1|12.7|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|
1721257|NCT00679380|3169930|Superiority or Other (legacy)||Difference in proportions|8.5||||0.2215|2-Sided|95.0|-5.0|22.0|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|
1721258|NCT00679380|3169930|Superiority or Other (legacy)||Difference in proportions|-8.0||||0.2174|2-Sided|95.0|-20.8|0.0|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.|
1721259|NCT00679380|3169931|Superiority or Other (legacy)||Difference in proportions|8.1||||0.0481|2-Sided|95.0|0.4|15.9|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|
1721260|NCT00679380|3169931|Superiority or Other (legacy)||Difference in proportions|12.9||||0.0047|2-Sided|95.0|4.6|21.3|||Chi-squared||See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).|
1721261|NCT00679380|3169931|Superiority or Other (legacy)||Difference in proportions|3.8||||0.2876|2-Sided|95.0|-3.0|10.5|||Chi-squared||The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).|All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Entocort EC and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Entocort EC versus budesonide MMX.|
1721262|NCT00679354|3169935|Superiority or Other||Spearman's Correlation Coefficient|-0.48||||0.114|2-Sided||||||Spearman's Correlation||||
1721263|NCT00679354|3169936|Superiority or Other||Spearman's Correlation Coefficient|-0.22||||0.495|2-Sided||||||Spearman's Correlation||||
1721264|NCT00679354|3169937|Superiority or Other||Spearman's Correlation Coefficient|0.56||||0.057|2-Sided||||||Spearman's Correlation||||
1721265|NCT00679354|3169938|Superiority or Other||Spearman's Correlation Coefficient|0.0||||1|2-Sided||||||Spearman's Correlation||||
1721266|NCT00678886|3170007|Superiority or Other|||||||0.653|||||||Hochberg-adjusted|||Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 12|
1721267|NCT00678886|3170007|Superiority or Other|||||||0.653|||||||Hochberg-adjusted|||Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 6|
1721268|NCT00678886|3170008|Superiority or Other|||||||0.957|||||||Hochberg-adjusted|||Composite Rank Summary for HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 12|
1721269|NCT00678886|3170008|Superiority or Other|||||||0.957|||||||Hochberg-adjusted|||Composite Rank Summary for HbA1c and Exogenous Insulin Use, Placebo Vs Otelixizumab at Month 6|
1721270|NCT00678886|3170009|Superiority or Other||Mean Difference (Final Values)|0.93||||0.462|2-Sided|95.0|-1.56|3.42|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Month 12|
1721271|NCT00678886|3170009|Superiority or Other||Mean Difference (Net)|0.83||||0.546|2-Sided|95.0|-1.89|3.56|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Month 6|
1721272|NCT00678886|3170009|Superiority or Other||Median Difference (Net)|1.12||||0.54|2-Sided|95.0|-0.88|3.11|||Mixed effects repeated measures model|||ADRR, Placebo Vs Otelixizumab at Week 12|
1721273|NCT00678886|3170018|Superiority or Other||Mean Difference (Net)|0.09||||0.538|2-Sided|95.0|-0.19|0.36|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Week 12|
1721274|NCT00678886|3170018|Superiority or Other||Mean Difference (Net)|0.17||||0.538|2-Sided|95.0|-0.15|0.49|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Month 6|
1721275|NCT00678886|3170018|Superiority or Other||Median Difference (Final Values)|0.18||||0.289|2-Sided|95.0|-0.16|0.52|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||HbA1c levels, Placebo Vs Otelixizumab at Month 12|
1721276|NCT00678886|3170019|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.272|2-Sided|95.0|-0.08|0.02|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Month 12|
1721277|NCT00678886|3170019|Superiority||Mean Difference (Net)|0.0||||0.969|2-Sided|95.0|-0.05|0.05|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Month 6|
1721278|NCT00678886|3170019|Superiority or Other||Mean Difference (Net)|-0.03||||0.281|2-Sided|95.0|-0.07|0.01|||Mixed effects repeated measures model|Mixed effects repeated measures models was adjusted for age, continent, and baseline parameter value.||Mean insulin use, Placebo Vs Otelixizumab at Week 12|
1721279|NCT00678886|3170020|Superiority or Other||Odds Ratio (OR)|0.81||||0.481|2-Sided|95.0|0.45|1.46|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Month 12|
1721280|NCT00678886|3170020|Superiority or Other||Odds Ratio (OR)|0.77||||0.737|2-Sided|95.0|0.42|1.39|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Month 6|
1721281|NCT00678886|3170020|Superiority or Other||Odds Ratio (OR)|0.9||||0.737|2-Sided|95.0|0.47|1.7|||Hochberg adjusted|||Percentage of responders, Placebo Vs Otelixizumab at Week 12|
1721282|NCT00678886|3170021|Superiority or Other||Mean Difference (Net)|0.01||||0.813|2-Sided|95.0|-0.06|0.08|||Mixed effects repeated measures model|||Mixed meal-stimulated C-peptide AUC, Placebo Vs Otelixizumab at Month 12|
1721283|NCT00678795|3170023|Superiority or Other||Estimated mean treatment difference|-0.85||||0.007|2-Sided|95.0|-1.47|-0.23|||ANCOVA|||The change in the number of voids per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of voids per day as a covariate.|
1721284|NCT00678795|3170024|Superiority or Other||Estimated mean treatment difference|25.4||||0.002|2-Sided|95.0|10.37|40.42|||Fisher Exact|||For Patient Global Impression of Change, the proportions of subjects who considered their condition ‘Very Much Improved’, ‘Much Improved’ or ‘Minimally Improved’ were compared between treatment groups using Fisher’s Exact Test.|
1721285|NCT00678795|3170025|Superiority or Other||Slope|-1.16||||0.001|2-Sided|95.0|-1.82|-0.51|||ANCOVA|||The change from baseline in the overall bladder condition Numerical Rating Scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline overall bladder condition Numerical Rating Scale score as a covariate.|
1721286|NCT00678795|3170026|Superiority or Other||Estimated mean treatment difference|3.9||||0.166|2-Sided|95.0|-1.65|9.46|||ANCOVA|||The change from baseline in the I-QOL score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline I-QOL score as a covariate.|
1721287|NCT00678795|3170027|Superiority or Other||Estimated mean treatment difference|-0.08||||0.74|2-Sided|95.0|-0.57|0.41|||ANCOVA|||The change in the number of incontinence pads used per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of number of incontinence pads used per day as a covariate.|
1721288|NCT00678795|3170028|Superiority or Other||Estimated mean treatment difference|-0.28||||0.01|2-Sided|95.0|-0.5|-0.07|||ANCOVA|||The change in the number of nocturia episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of nocturia episodes per day as a covariate.|
1721289|NCT00678795|3170029|Superiority or Other||Estimated mean treatment difference|-0.76||||0.071|2-Sided|95.0|-1.58|0.07|||ANCOVA|||The change in the number of urgency episodes per day was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline number of urgency episodes per day as a covariate.|
1721290|NCT00678795|3170030|Superiority or Other||Estimated mean treatment difference|-0.11||||0.569|2-Sided|95.0|-0.47|0.26|||ANCOVA|||The primary endpoint, the change in the number of incontinence episodes per day, was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline number of incontinence episodes per day as a covariate.|
1721291|NCT00678691|3170031|Superiority or Other||||||<|0.05||||||all p-values come from one model analysis and are therefore included in free text as such|piecewise model|A piecewise statistical model results for between group differences: P=.390 (baseline through week 5), p=.775 (week 5 – week 8||Authors expected armodafinal to work better than placebo reducing BFI scale scores by 30%. A piecewise statistical model was used to compare baseline scores against those over through week 8. Piecewise results for between group differences for BFI Scores: P=.390 (baseline through week 5), p=.775 (week 5 – week 8).|
1721292|NCT00678639|3170039|Superiority or Other||||||<|0.001|||||||Fisher Exact|||"H0: There is no difference in correct cardiovascular admission decisions among groups.~Ha: A difference exists among study groups. Sample size was based upon 47 analyzable participants per study arm were required to provide 88% power to detect a 30% difference in the outcome."|
1721293|NCT00678639|3170040|Superiority or Other||Median cost difference|588.0|||||2-Sided|95.0|336.0|811.0|||||Results favored a reduced cost in the OU-CMR group.|H0: The median costs are not different among the study groups. HA: The median cost is different among groups. Power calculation was based on detecting a mean cost difference of $2000. Data was found to be non-normally distributed and therefore nonparametric comparisons were implemented.|
1721294|NCT00678587|3170054|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1721295|NCT00678587|3170055|Superiority or Other||Risk Difference (RD)|-5.9|||||2-Sided|95.0|-15.1|3.3|||||||
1721296|NCT00678587|3170056|Superiority or Other||Absolute difference in proportions|52.8|||<|0.0001|2-Sided|95.0|43.2|62.4|||Cochran-Mantel-Haenszel||||
1721297|NCT00678535|3170061|Superiority or Other||Odds Ratio (OR)|1.0435||||0.7696||95.0|0.7844|1.3882|||Cochran-Mantel-Haenszel|||The best overall response rate was compared with the Cochran-Mantel-Haenszel test (strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo−) adjuvant(radio) chemotherapy, two-sided with α=5%).|
1721298|NCT00678535|3170062|Superiority or Other||Hazard Ratio (HR)|1.004||||0.9547||95.0|0.866|1.165|||Stratified log rank||Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior (neo−) adjuvant(radio) chemotherapy, α=5%)|
1721375|NCT00676715|3170267|Superiority or Other (legacy)|||||||0.1391|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.|||
1725638|NCT00614380|3178332|Superiority or Other||Odds Ratio (OR)|0.25||||||95.0|0.16|0.39|||||||
1721299|NCT00678535|3170063|Superiority or Other||Hazard Ratio (HR)|1.091||||0.3158||95.0|0.92|1.292|||Stratified log rank||Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|Primary efficacy analysis: To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (randomization strata: disease stage, previous oesophagectomy/gastrectomy and prior(neo−) adjuvant(radio) chemotherapy, α=5%).|
1721300|NCT00678470|3170064|Other||Correlation|1.0||||0.0003|2-Sided||||||Fisher Exact||||Using Fisher’s non-parametric test of associations, correlations were determined between the patients who were intralesional responders with their response at ‡70% change in PASI score.
1721301|NCT00678418|3170067|Superiority or Other|||||||0.0031|||||||van der Waerden|||Null hypothesis: Treatment difference=0. Missing data from subjects due to early discontinuation during Part A were imputed using the baseline rate; thus data for subjects who discontinued early were imputed as having no change from baseline.|
1721302|NCT00678418|3170068|Superiority or Other||Risk Ratio (RR)|0.75||||0.0154||95.0|0.6|0.95|||Chi-squared|||"Chi-square test was used to calculate the p-value for treatment. Null hypothesis = no association between relapse to dependence and study treatment.~Subjects who discontinued prematurely from the study were imputed as having a positive naloxone challenge test result."|
1721303|NCT00678418|3170069|Superiority or Other||||||<|0.0001|||||||Chi-squared|||"P-value was calculated using the Chi-square test for the null hypothesis: mean treatment difference = 0.~Calculations were based on the Generalized Estimating Equation (GEE) model (normal distribution, identity link and AR(1) correlation structure) for repeated data on change from baseline with treatment and visit as main effects, and baseline as a covariate. Missing data were imputed using the Last Observation Carried Forward (LOCF) method."|
1721304|NCT00678418|3170070|Superiority or Other|||||||0.0042||||||A total of 114 subjects continued on-study beyond the 168-day endpoint for Part A; these subjects were censored as of the first dosing day in Part B.|Kaplan Meier|||P-value was calculated using the log-rank test for the null hypothesis: the distribution of days to discontinuation does not differ by treatment.|
1721305|NCT00678418|3170071|Superiority or Other|||||||0.0002|||||||Van der Waerden|||Null hypothesis = the distribution function of opioid-free weeks is the same for both treatment groups.|
1721306|NCT00678392|3170083|Superiority or Other||Risk Ratio (RR)|2.056||||0.0001|2-Sided|95.0|1.408|3.003|||Cochran-Mantel-Haenszel|P-value was obtained from a 1-sided Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior treatment.|||
1721307|NCT00678392|3170084|Superiority or Other||Hazard Ratio (HR)|0.969||||0.3744|2-Sided|95.0|0.8|1.174|||Log Rank|P-value was obtained from a 1-sided log-rank test of treatment stratified by ECOG performance status and prior treatment.|||
1721308|NCT00678392|3170085|Superiority or Other||Hazard Ratio (HR)|0.665|||<|0.0001|2-Sided|95.0|0.544|0.812||P-value was obtained from 1-sided log rank test, stratified by eastern cooperative oncology group (ECOG) and prior treatment. One-sided log-rank test at 0.025 level of significance was used to compare PFS between the 2 treatment arms.|Log Rank||||
1721309|NCT00678249|3170132|Superiority or Other||||||<|0.001|||||||Regression, Logistic||||
1721310|NCT00677833|3170171|Superiority or Other|||||||0.0006|||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.|
1721311|NCT00677833|3170174|Superiority or Other||||||<|0.0001|||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.|
1721312|NCT00677833|3170175|Superiority or Other|||||||0.2564|||||||Kaplan-Meier, log rank|||Time to event data was analyzed using the Kaplan-Meier curve.|
1721313|NCT00677833|3170176|Superiority or Other||percent difference|-11.21|||||2-Sided|95.0|-20.14|-2.28||||||Day 42|
1721314|NCT00677833|3170176|Superiority or Other||percent difference|-10.34|||||2-Sided|95.0|-18.97|-1.71||||||Day 35|
1721315|NCT00677833|3170176|Superiority or Other||percent difference|-11.11|||||2-Sided|95.0|-19.62|-2.6||||||Day 28|
1721316|NCT00677833|3170176|Superiority or Other||percent difference|-12.75|||||2-Sided|95.0|-21.45|-4.04||||||Day 21|
1721317|NCT00677833|3170176|Superiority or Other||percent difference|-10.39|||||2-Sided|95.0|-19.23|-1.55||||||Day 14|
1721318|NCT00677833|3170176|Superiority or Other||percent difference|-9.51|||||2-Sided|95.0|-18.27|-0.74||||||Day 7|
1721319|NCT00677833|3170177|Superiority or Other||percent difference|-8.52|||||2-Sided|95.0|-15.43|-1.6||||||Day 42|
1721320|NCT00677833|3170177|Superiority or Other||percent difference|-7.71|||||2-Sided|95.0|-14.45|-0.97||||||Day 35|
1721321|NCT00677833|3170177|Superiority or Other||percent difference|-9.26|||||2-Sided|95.0|-15.64|-2.87||||||Day 28|
1721322|NCT00677833|3170177|Superiority or Other||percent difference|-7.6|||||2-Sided|95.0|-13.61|-1.6||||||Day 21|
1721323|NCT00677833|3170177|Superiority or Other||percent difference|-7.55|||||2-Sided|95.0|-13.14|-1.95||||||Day 14|
1721324|NCT00677833|3170177|Superiority or Other||percent difference|-5.89|||||2-Sided|95.0|-11.02|-0.75||||||Day 7|
1721325|NCT00677833|3170184|Superiority or Other||ACPR Percent difference|-16.94|||||2-Sided|95.0|-30.04|-3.83||||||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)- (AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the Greenwood formula. Estimates for Day 42.|
1721326|NCT00677833|3170184|Superiority or Other||ACPR percent difference|-16.38|||||2-Sided|95.0|-29.42|-3.33||||||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.|
1721327|NCT00677833|3170184|Superiority or Other||ACPR percent difference|-19.62|||||2-Sided|95.0|-32.16|-7.08||||||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.|
1721376|NCT00676715|3170268|Superiority or Other (legacy)||Relative risk (RR)|0.92||||0.8206|2-Sided|95.0|0.46|1.84|||CMH chi-square tes|CMH chi-square test stratified by geographical region only.|||
1721328|NCT00677833|3170184|Superiority or Other||ACPR percent difference|-13.07|||||2-Sided|95.0|-24.21|-1.92||||||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.|
1721329|NCT00677833|3170184|Superiority or Other||ACPR percent difference|-4.67|||||2-Sided|95.0|-10.6|1.25||||||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.|
1721330|NCT00677833|3170185|Superiority or Other||ACPR Percent difference|-18.49|||||2-Sided|95.0|-31.33|-5.65||||||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.|
1721331|NCT00677833|3170185|Superiority or Other||ACPR percent difference|-18.24|||||2-Sided|95.0|-31.05|-5.43||||||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.|
1721332|NCT00677833|3170185|Superiority or Other||ACPR percent difference|-21.76|||||2-Sided|95.0|-34.14|-9.39||||||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 28.|
1721333|NCT00677833|3170185|Superiority or Other||ACPR percent difference|-15.09|||||2-Sided|95.0|-26.24|-3.94||||||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.|
1721334|NCT00677833|3170185|Superiority or Other||ACPR percent difference|-7.71|||||2-Sided|95.0|-14.54|-0.88||||||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.|
1721335|NCT00677833|3170185|Superiority or Other||ACPR percent difference|-5.04|||||2-Sided|95.0|-9.93|-0.15||||||A two-sided 95% CI for the difference in ACPR (PCR-uncorrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.|
1721336|NCT00677833|3170186|Superiority or Other||ACPR percent difference|-5.66|||||2-Sided|95.0|-13.55|2.22||||||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.|
1721337|NCT00677833|3170186|Superiority or Other||ACPR percent difference|-3.87|||||2-Sided|95.0|-10.79|3.04||||||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.|
1721338|NCT00677833|3170186|Superiority or Other||ACPR percent difference|-3.63|||||2-Sided|95.0|-8.4|1.14||||||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.|
1721339|NCT00677833|3170187|Superiority or Other||ACPR percent difference|-8.63|||||2-Sided|95.0|-17.08|-0.18||||||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 42.|
1721340|NCT00677833|3170187|Superiority or Other||ACPR percent difference|-6.92|||||2-Sided|95.0|-14.59|0.76||||||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 35.|
1721341|NCT00677833|3170187|Superiority or Other||ACPR percent difference|-6.78|||||2-Sided|95.0|-12.82|-0.75||||||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 21.|
1721342|NCT00677833|3170187|Superiority or Other||ACPR percent difference|-6.74|||||2-Sided|95.0|-12.15|-1.32||||||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 14.|
1721343|NCT00677833|3170187|Superiority or Other||ACPR percent difference|-5.04|||||2-Sided|95.0|-9.93|-0.15||||||A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. Estimates for Day 7.|
1721377|NCT00676715|3170268|Superiority or Other (legacy)||Relative risk (RR)|0.53||||0.131|2-Sided|95.0|0.23|1.22|||CMH chi-square test|CMH chi-square test stratified by geographical region only.|||
1722539|NCT00666406|3171636|Superiority or Other||Ratio of the geometric means|0.964|||||2-Sided|90.0|0.799|1.164|||||||
1721344|NCT00677833|3170188|Non-Inferiority or Equivalence|A two-sided 95% CI for the difference in ACPR (PCR-corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was >= -10% points.|ACPR percent difference|-6.08|||||2-Sided|95.0|-12.1|-0.05||||||Null hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is less than that of AL; Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.|
1721345|NCT00677833|3170189|Non-Inferiority or Equivalence|A two-sided 95 percent (%) confidence interval (CI) for the difference in ACPR (PCR corrected) proportions [(AZ-CQ)–(AL)] using the normal approximation to the binomial with continuity correction was constructed based on the estimated ACPR (PCR-corrected) proportions from the Kaplan-Meier curves and their standard errors estimated by the greenwood formula. The drug (AZ-CQ) was considered non-inferior with respect to this primary endpoint if the lower bound of this 95% CI was >= -10% points.|ACPR percent difference|-9.1|||||2-Sided|95.0|-16.02|-2.18||||||Null hypothesis: proportion of participants with ACPR (PCR-corrected) of Azithromycin/Chloroquine (AZ-CQ) at Day 28 is less than that of Artemether/Lumefantrine (AL); Alternative hypothesis: proportion of participants with ACPR (PCR-corrected) of AZ-CQ at Day 28 is greater than or equal (non-inferior) to that of AL by a non-inferiority margin of -0.1.|
1721346|NCT00677690|3170205|Superiority or Other||||||<|0.05|||||||t-test, 1 sided||||
1721347|NCT00677690|3170206|Superiority or Other||||||<|0.05|||||||t-test, 1 sided||||
1721348|NCT00677690|3170207|Superiority or Other||||||<|0.05|||||||t-test, 1 sided||||
1721349|NCT00677690|3170208|Superiority or Other||||||<|0.05|||||||t-test, 1 sided||||
1721350|NCT00677690|3170209|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|||"All data were expressed as the mean ± SD. The level of significance for all tests was set at p < 0.05.~Inter- and intra-group comparisons were performed using both paired and unpaired t tests for continuous variables and Chi squared for categorical variables."|
1721351|NCT00677365|3170212|Superiority or Other||Mean Difference (Final Values)|4.5||||0.2174|2-Sided|95.0|-2.68|11.67|||Mixed Models Analysis|||LS Mean Difference from MP-376 240 mg BID to placebo groups|
1721352|NCT00677365|3170213|Superiority or Other||Mean Difference (Final Values)|10.94||||0.0008|2-Sided|95.0|4.63|17.25|||Mixed Models Analysis|||LS Mean Difference Between Placebo and MP-376 240 mg BID groups|
1721353|NCT00677365|3170214|Superiority or Other||Mean Difference (Final Values)|8.61||||0.0026|2-Sided|95.0|3.05|14.17|||Mixed Models Analysis|||LS Mean Difference Between MP-376 240 mg and Placebo groups|
1721354|NCT00677365|3170215|Superiority or Other||Hazard Ratio (HR)|0.21||||0.0007|2-Sided|95.0|0.09|0.52|||Regression, Cox|||Hazard Ratio for need of anti-pseudomonal antimicrobials; Estimates are obtained from a Cox proportional hazards regression model including terms for treatment, region, baseline P.aeruginosa density (log10 ), highest baseline MIC of levofloxacin against P. aeruginosa (log2 ), and baseline percent predicted FEV1 (quartiles)|
1721355|NCT00677365|3170216|Superiority or Other||Mean Difference (Final Values)|-0.96||||0.0014|2-Sided|95.0|-1.54|-0.38||Repeated Measure Model|Mixed Models Analysis|||LS Mean Difference|
1721356|NCT00677352|3170217|Superiority or Other|||||||0.0062||||||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05 (two-sided).|Fisher Exact||||
1721357|NCT00677352|3170223|Non-Inferiority or Equivalence|Sertraline was concluded to be non-inferior to paroxetine when the upper limit of the CI fell below the non-inferiority margin of 4.|Mean Difference (Final Values)|-0.4|||||2-Sided|95.0|-2.5|1.6||||||The two-sided 95% confidence interval (CI) of the intergroup difference (sertraline group – paroxetine group) of the mean reduction in the PAS total score at each dose during the treatment phase was calculated using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline PAS total score as a covariate.|
1721358|NCT00677235|3170233|Superiority or Other|||||||0.449|||||||Fisher Exact||||
1721359|NCT00677040|3170249|Other||t-test|0.35||||0.5|2-Sided||||||t-test, 2 sided||||
1721360|NCT00677040|3170249|Equivalence|t-test to determine if tissue oxygen measurements are equivalent between treated and nontreated breast|t-test|0.35||||0.5|2-Sided||||||t-test, 2 sided||||
1721361|NCT00677014|3170251|Superiority or Other||Mean Difference (Net)|-0.1||||0.66||95.0|||||ANOVA|As LVESV values were non normal by Q-Q analysis and Shapiro-Wilk test (p<.05), a square root transform was used. model adjusted for baseline LVESV.||Gate keeping strategy utilized for Type 1 error control described in design paper - negative results observed for initial comparisons - (each at alpha = .05) between fixed and algorithm optimized AV delay and fixed and Echo optimzied AV. Results from both of these comparisons were non-significant.|
1721362|NCT00676793|3170260|Superiority or Other||||||=|0|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no change, i.e. median change=0.0.|
1721363|NCT00676793|3170261|Superiority or Other||||||=|0|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no change, i.e. median change=0.0.|
1721364|NCT00676780|3170262|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is no change, i.e. median change = 0.0|
1721365|NCT00676780|3170263|Superiority or Other|||||||0.023|||||||Wilcoxon (Mann-Whitney)||||
1721366|NCT00676780|3170264|Superiority or Other||||||=|0|||||||Wilcoxon (Mann-Whitney)||||
1721367|NCT00676715|3170265|Superiority or Other (legacy)|||||||0.2725|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.|||
1721368|NCT00676715|3170265|Superiority or Other (legacy)||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.|||
1721369|NCT00676715|3170265|Superiority or Other (legacy)||||||<|0.0004|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.|||
1721370|NCT00676715|3170266|Superiority or Other (legacy)|||||||0.4985|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.|||
1721371|NCT00676715|3170266|Superiority or Other (legacy)||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.|||
1721372|NCT00676715|3170266|Superiority or Other (legacy)||||||<|0.0001|||||||Van Elteren Test (stratified)|Van Elteren test is stratified by region only.|||
1721378|NCT00676715|3170268|Superiority or Other (legacy)||Relative risk (RR)|0.6||||0.1978|2-Sided|95.0|0.27|1.34|||Cochran-Mantel-Haenszel chi-square test|Cochran-Mantel-Haenszel (CMH) chi-square test stratified by geographical region only.|||
1721379|NCT00676715|3170269|Superiority or Other (legacy)|||||||0.1814|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.|
1721380|NCT00676715|3170269|Superiority or Other (legacy)|||||||0.0136|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.|
1721381|NCT00676715|3170269|Superiority or Other (legacy)|||||||0.0019|||||||Poisson model|||Poisson model was fitted for adjusting for geographic region only.|
1721382|NCT00676715|3170270|Superiority or Other (legacy)|||||||0.7496|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).|
1721383|NCT00676715|3170270|Superiority or Other (legacy)||||||<|0.0001|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).|
1721384|NCT00676715|3170270|Superiority or Other (legacy)||||||<|0.0001|||||||Van Elteren Test (stratified)|||Van Elteren test is stratified by region and presence of baseline gadolinium-enhancing lesions (absent or present).|
1721385|NCT00676689|3170271|Superiority or Other (legacy)||Percentage|87.9|||||2-Sided|||||||||Overall functional improvement at 6 months for patients in the valve implant population with baseline and 6 month data.|
1721386|NCT00676689|3170272|Superiority or Other (legacy)||Kaplan-Meier|0.941|Standard Error of the Mean|0.028|||2-Sided|95.0|0.851|0.978||||||Freedom from Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) at 6 months in the valve implant population.|
1721387|NCT00676689|3170273|Superiority or Other (legacy)||Kaplan-Meier|0.971|Standard Error of the Mean|0.02|||2-Sided|95.0|0.889|0.993|||||||
1721388|NCT00676676|3170274|Superiority or Other|||||||0.004|||||||t-test, 2 sided|||Baseline versus 8-week|
1721389|NCT00676676|3170274|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||Baseline versus 2-week|
1721390|NCT00676663|3170275|Superiority||Hazard Ratio (HR)|0.59||||0.018|2-Sided|95.0|0.36|0.97||P-value is stratified by the randomization stratification factors and is 1-sided.|Log Rank||Hazard ratio was estimated from a Cox proportional hazards model. Placebo serves as the reference treatment group for the interpretation of the hazard ratio.||
1721391|NCT00676663|3170279|Superiority||Hazard Ratio (HR)|0.73||||0.06|2-Sided|95.0|0.49|1.09|||Log Rank|P-value is stratified by the randomization stratification factors and is 1-sided, with a 0.10 threshold for significance.|||
1721392|NCT00676650|3170284|Superiority or Other||Odds Ratio (OR)|3.561||||0.04|2-Sided|95.0|1.0|19.0||p-value from 2-sided Fisher's Exact test.|Fisher Exact||||
1721393|NCT00676650|3170285|Superiority or Other||Hazard Ratio (HR)|0.725|||<|0.001|2-Sided|95.0|0.591|0.89||1-sided p-value from the stratified log-rank test.|Log Rank||Based on Cox Proportional Hazards Model stratified by ECOG and Disease Progression Base.||
1721394|NCT00676650|3170286|Superiority or Other||Hazard Ratio (HR)|0.914||||0.1678|2-Sided|95.0|0.762|1.097||1-sided p-value from the stratified log-rank test|Log Rank||Based on the Cox Proportional hazards model stratified by Eastern Cooperative Oncology Group (ECOG) and Disease Progression Base.||
1721395|NCT00676572|3170290|Superiority||||||<|0.05||||||calculated p values|t-test, 2 sided||||
1721396|NCT00676403|3170340|Superiority or Other|||||||0.4709|||||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.|
1721397|NCT00676403|3170340|Superiority or Other|||||||0.1873|||||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.|
1721398|NCT00676403|3170340|Superiority or Other|||||||0.0942|||||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.|
1721399|NCT00676403|3170340|Superiority or Other|||||||0.4342|||||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.|
1721400|NCT00676403|3170340|Superiority or Other|||||||0.4452|||||||Cochran-Mantel-Haenszel|||CHM test for difference; p-value was adjusted for geographic region at each visit.|
1721401|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|9.7||||0.0442||95.0|0.3|19.2|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721402|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|4.8||||0.312||95.0|-4.5|14.1|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721403|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|4.4||||0.3793||95.0|-5.5|14.4|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721404|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|3.0||||0.5255||95.0|-6.3|12.2|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721405|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|3.2||||0.5148||95.0|-6.4|12.8|||ANCOVA|||Summary Emotional Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721406|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|5.2||||0.2073||95.0|-2.9|13.2|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721407|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|1.0||||0.7994||95.0|-6.9|9.0|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721408|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|3.7||||0.3955||95.0|-4.9|12.3|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721409|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|2.2||||0.5776||95.0|-5.6|10.1|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721410|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|2.8||||0.4966||95.0|-5.4|11.0|||ANCOVA|||Summary Physical Score: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721411|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|7.9||||0.1203||95.0|-2.1|17.8|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721412|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|0.9||||0.8621||95.0|-8.9|10.6|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721413|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|4.7||||0.3735||95.0|-5.7|15.1|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721414|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|0.7||||0.8875||95.0|-9.1|10.5|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721415|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|-1.8||||0.7201||95.0|-11.9|8.2|||ANCOVA|||Mental Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721416|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|14.8||||0.0154||95.0|2.9|26.7|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721417|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|10.2||||0.085||95.0|-1.4|21.8|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721418|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|3.1||||0.6222||95.0|-9.2|15.4|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721419|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|9.9||||0.0916||95.0|-1.6|21.4|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721420|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|8.7||||0.1508||95.0|-3.2|20.7|||ANCOVA|||Role-Emotional: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721421|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|7.8||||0.1753||95.0|-3.5|19.1|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721422|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|1.6||||0.7769||95.0|-9.6|12.8|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721423|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|-3.4||||0.5668||95.0|-15.3|8.4|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721424|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|-3.1||||0.5824||95.0|-14.1|7.9|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721425|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|0.4||||0.9416||95.0|-11.0|11.9|||ANCOVA|||Social Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721426|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|6.5||||0.2543||95.0|-4.7|17.7|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721427|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|4.3||||0.4443||95.0|-6.8|15.4|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721428|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|11.1||||0.0677||95.0|-0.8|23.0|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721429|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|2.5||||0.6566||95.0|-8.5|13.5|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721430|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|3.7||||0.5281||95.0|-7.8|15.1|||ANCOVA|||Vitality: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721431|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.8636||95.0|-8.7|7.3|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721432|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|-2.9||||0.4599||95.0|-10.8|4.9|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721433|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|1.0||||0.8158||95.0|-7.4|9.4|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721434|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|-2.6||||0.5142||95.0|-10.3|5.2|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721435|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.7544||95.0|-9.5|6.9|||ANCOVA|||General Health: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721436|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|11.2||||0.0644||95.0|-0.7|23.0|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721437|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|6.4||||0.2791||95.0|-5.3|18.0|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721438|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|10.0||||0.1209||95.0|-2.7|22.7|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721439|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|6.0||||0.3076||95.0|-5.6|17.5|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721440|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|8.9||||0.1441||95.0|-3.1|20.9|||ANCOVA|||Bodily Pain: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721441|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|8.5||||0.1661||95.0|-3.6|20.6|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721442|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.9604||95.0|-12.1|11.5|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721443|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|6.6||||0.3058||95.0|-6.1|19.2|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721444|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|6.4||||0.2849||95.0|-5.4|18.1|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721445|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|5.9||||0.3421||95.0|-6.3|18.1|||ANCOVA|||Role-Physical: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721446|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9963||95.0|-10.0|9.9|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721447|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.886||95.0|-10.5|9.1|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1722327|NCT00667810|3171329|Superiority or Other||Mean Difference (Final Values)|2.01||||0.375|2-Sided|95.0|-2.44|6.46|||Mixed Models Analysis||||
1721448|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|-4.1||||0.4429||95.0|-14.5|6.4|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721449|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.8015||95.0|-10.9|8.5|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721450|NCT00676403|3170341|Superiority or Other||Mean Difference (Final Values)|-3.1||||0.5384||95.0|-13.2|7.0|||ANCOVA|||Physical Functioning: Least Squares mean difference. LS Mean, Std. Error, 95% CI and P-value are from an analysis of covariance (ANCOVA) with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721451|NCT00676403|3170342|Superiority or Other||Mean Difference (Final Values)|5.4||||0.3031||95.0|-5.0|15.8|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721452|NCT00676403|3170342|Superiority or Other||Mean Difference (Final Values)|0.9||||0.8645||95.0|-9.4|11.1|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721453|NCT00676403|3170342|Superiority or Other||Mean Difference (Final Values)|5.8||||0.285||95.0|-4.9|16.5|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721454|NCT00676403|3170342|Superiority or Other||Mean Difference (Final Values)|7.3||||0.1585||95.0|-2.9|17.5|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721455|NCT00676403|3170342|Superiority or Other||Mean Difference (Final Values)|4.6||||0.3932||95.0|-6.0|15.2|||ANCOVA|||Analysis of covariance of change from baseline; LS Mean, standard error, 95% CI and P-value are from an analysis of covariance (ANCOVA), with treatment and geographic region as main effects and baseline value as covariate in the model.|
1721456|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|1.9|Standard Error of the Mean|1.34||0.3382||95.0|0.5|7.5|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721457|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|0.4|Standard Error of the Mean|0.29||0.2042||95.0|0.1|1.6|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721458|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|1.7|Standard Error of the Mean|1.17||0.4632||95.0|0.4|6.6|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721459|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|1.0|Standard Error of the Mean|0.61||0.9566||95.0|0.3|3.3|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721460|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|1.0|Standard Error of the Mean|0.72||0.9855||95.0|0.2|4.1|||Regression, Logistic|||Week 6: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721461|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|1.6|Standard Error of the Mean|1.08||0.4673||95.0|0.4|6.0|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721462|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|1.7|Standard Error of the Mean|1.04||0.4165||95.0|0.5|5.6|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721463|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|1.7|Standard Error of the Mean|1.12||0.4156||95.0|0.5|6.2|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721464|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|1.3|Standard Error of the Mean|0.8||0.7169||95.0|0.4|4.4|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1722259|NCT00670488|3171024|Other||AUC 0-168hr GMR|1.54||||||||||||||The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.|
1721465|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|1.6|Standard Error of the Mean|1.09||0.4923||95.0|0.4|6.1|||Regression, Logistic|||Week 4: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721466|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|4.1|Standard Error of the Mean|2.8||0.0385||95.0|1.1|15.6|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721467|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|2.4|Standard Error of the Mean|1.48||0.1583||95.0|0.7|8.1|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721468|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|2.8|Standard Error of the Mean|1.85||0.1073||95.0|0.8|10.2|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721469|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|3.2|Standard Error of the Mean|2.07||0.0711||95.0|0.9|11.4|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means.Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721470|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|1.0|Standard Error of the Mean|0.74||0.9569||95.0|0.2|4.3|||Regression, Logistic|||Week 2: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721471|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|4.6|Standard Error of the Mean|2.9||0.0169||95.0|1.3|15.9|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721472|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|1.3|Standard Error of the Mean|0.99||0.7671||95.0|0.3|5.9|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721473|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|4.6|Standard Error of the Mean|3.1||0.0249||95.0|1.2|17.2|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721474|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|2.2|Standard Error of the Mean|1.58||0.2947||95.0|0.5|9.1|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721475|NCT00676403|3170343|Superiority or Other||Odds Ratio (OR)|3.7|Standard Error of the Mean|2.65||0.0646||95.0|0.9|15.0|||Regression, Logistic|||Week 1: Contrast of treatment vs. placebo. Differences in proportions were obtained using LS means. Repeated measures logistic regression model used fixed effects including treatment, geographic region, week, and the treatment by week interaction. The within-subject covariance structure was modeled as compound sysmetric.|
1721476|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-12.6|Standard Error of the Mean|5.48||0.0224||95.0|-23.4|-1.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721477|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-5.5|Standard Error of the Mean|5.42||0.3077||95.0|-16.2|5.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721478|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-11.6|Standard Error of the Mean|5.68||0.0424||95.0|-22.8|-0.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721479|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-5.4|Standard Error of the Mean|5.35||0.3153||95.0|-15.9|5.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721480|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-10.7|Standard Error of the Mean|5.54||0.0537||95.0|-21.7|0.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721481|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-10.9|Standard Error of the Mean|5.45||0.0475||95.0|-21.6|-0.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721482|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-8.8|Standard Error of the Mean|5.4||0.1062||95.0|-19.4|1.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721483|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-6.9|Standard Error of the Mean|5.61||0.2166||95.0|-18.0|4.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721484|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-3.8|Standard Error of the Mean|5.3||0.477||95.0|-14.2|6.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721485|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|5.48||0.8519||95.0|-11.8|9.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721486|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-9.0|Standard Error of the Mean|5.42||0.0963||95.0|-19.7|1.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721487|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-7.8|Standard Error of the Mean|5.37||0.1484||95.0|-18.4|2.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721488|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-7.0|Standard Error of the Mean|5.58||0.2141||95.0|-17.9|4.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721489|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-3.5|Standard Error of the Mean|5.3||0.5081||95.0|-13.9|6.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721490|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-7.9|Standard Error of the Mean|5.49||0.1494||95.0|-18.8|2.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721491|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-10.7|Standard Error of the Mean|5.35||0.047||95.0|-21.2|-0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721492|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-6.3|Standard Error of the Mean|5.36||0.2424||95.0|-16.8|4.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721493|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-9.6|Standard Error of the Mean|5.56||0.0848||95.0|-20.6|1.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722540|NCT00666406|3171637|Superiority or Other||Ratio of the geometric means|0.881|||||2-Sided|90.0|0.847|0.916|||||||
1721494|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-6.1|Standard Error of the Mean|5.33||0.2532||95.0|-16.6|4.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721495|NCT00676403|3170344|Superiority or Other||Mean Difference (Final Values)|-7.8|Standard Error of the Mean|5.44||0.1547||95.0|-18.5|3.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721496|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-12.1|Standard Error of the Mean|5.41||0.0262||95.0|-22.7|-1.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721497|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-3.3|Standard Error of the Mean|5.34||0.5431||95.0|-13.8|7.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721498|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-10.5|Standard Error of the Mean|5.6||0.0613||95.0|-21.6|0.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721499|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-5.6|Standard Error of the Mean|5.28||0.2932||95.0|-16.0|4.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721500|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-9.4|Standard Error of the Mean|5.47||0.0857||95.0|-20.2|1.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721501|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-11.7|Standard Error of the Mean|5.38||0.0306||95.0|-22.3|-1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721502|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-7.2|Standard Error of the Mean|5.31||0.1757||95.0|-17.7|3.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721503|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-6.1|Standard Error of the Mean|5.53||0.2687||95.0|-17.0|4.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721504|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-2.4|Standard Error of the Mean|5.22||0.6469||95.0|-12.7|7.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721505|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|5.4||0.8895||95.0|-11.4|9.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721506|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-9.3|Standard Error of the Mean|5.34||0.0837||95.0|-19.8|1.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721507|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-5.3|Standard Error of the Mean|5.28||0.3205||95.0|-15.7|5.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722541|NCT00666406|3171638|Superiority or Other||Ratio of the geometric means|0.854|||||2-Sided|90.0|0.798|0.913|||||||
1721508|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-5.4|Standard Error of the Mean|5.5||0.3252||95.0|-16.3|5.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721509|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|5.22||0.8711||95.0|-11.1|9.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721510|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-7.2|Standard Error of the Mean|5.41||0.1834||95.0|-17.9|3.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721511|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-7.0|Standard Error of the Mean|5.27||0.1853||95.0|-17.4|3.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721512|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-4.7|Standard Error of the Mean|5.27||0.3708||95.0|-15.1|5.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721513|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-5.7|Standard Error of the Mean|5.48||0.2958||95.0|-16.5|5.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721514|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|5.25||0.823||95.0|-11.5|9.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721515|NCT00676403|3170345|Superiority or Other||Mean Difference (Final Values)|-3.3|Standard Error of the Mean|5.36||0.5409||95.0|-13.8|7.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721516|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.31||0.0554||95.0|0.0|1.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721517|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.3||0.7574||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721518|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.7|Standard Error of the Mean|0.32||0.0406||95.0|0.0|1.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721519|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.3||0.7699||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721520|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.31||0.4144||95.0|-0.4|0.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721521|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.31||0.09||95.0|-0.1|1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722328|NCT00667810|3171329|Superiority or Other||Mean Difference (Final Values)|3.2||||0.149|2-Sided|95.0|-1.15|7.56|||Mixed Models Analysis||||
1721522|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.3||0.1314||95.0|-0.1|1.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721523|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.8|Standard Error of the Mean|0.32||0.0188||95.0|0.1|1.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721524|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.3||0.6791||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721525|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.31||0.2223||95.0|-0.2|1.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721526|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.31||0.0561||95.0|0.0|1.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721527|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.3||0.5068||95.0|-0.4|0.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721528|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.7|Standard Error of the Mean|0.32||0.0355||95.0|0.0|1.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721529|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.3||0.7614||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721530|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.31||0.3692||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721531|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.3||0.3291||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721532|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.3||0.7831||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721533|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.32||0.0773||95.0|-0.1|1.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721534|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.3||0.7242||95.0|-0.5|0.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721535|NCT00676403|3170346|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.31||0.2978||95.0|-0.3|0.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722074|NCT00673465|3170666|Superiority or Other||Difference in least squares mean|-26.6|||<|0.0001|2-Sided|95.0|-33.8|-19.4|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.|||
1721536|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-2.2|Standard Error of the Mean|5.93||0.7146||95.0|-13.9|9.5|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721537|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-1.7|Standard Error of the Mean|5.81||0.7764||95.0|-13.1|9.8|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721538|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-10.0|Standard Error of the Mean|6.15||0.1057||95.0|-22.1|2.1|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721539|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-3.0|Standard Error of the Mean|5.79||0.6007||95.0|-14.4|8.4|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721540|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-14.6|Standard Error of the Mean|6.01||0.0157||95.0|-26.5|-2.8|||Mixed Models Analysis|||Week 6: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721541|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|1.4|Standard Error of the Mean|5.9||0.8096||95.0|-10.2|13.0|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721542|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-2.9|Standard Error of the Mean|5.78||0.6188||95.0|-14.3|8.5|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721543|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-2.2|Standard Error of the Mean|6.07||0.7216||95.0|-14.1|9.8|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721544|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|2.2|Standard Error of the Mean|5.72||0.7041||95.0|-9.1|13.5|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721545|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-6.4|Standard Error of the Mean|5.94||0.2842||95.0|-18.1|5.3|||Mixed Models Analysis|||Week 4: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721546|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|5.86||0.8273||95.0|-10.3|12.8|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721547|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|2.6|Standard Error of the Mean|5.75||0.6509||95.0|-8.7|13.9|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721548|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-4.9|Standard Error of the Mean|6.04||0.4177||95.0|-16.8|7.0|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721549|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|2.8|Standard Error of the Mean|5.72||0.6202||95.0|-8.4|14.1|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722542|NCT00666406|3171639|Superiority or Other||Ratio of the geometric means|1.093|||||2-Sided|90.0|1.007|1.186|||||||
1721550|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-4.3|Standard Error of the Mean|5.95||0.4708||95.0|-16.0|7.4|||Mixed Models Analysis|||Week 2: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721551|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-3.3|Standard Error of the Mean|5.78||0.5706||95.0|-14.7|8.1|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721552|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-3.8|Standard Error of the Mean|5.73||0.5102||95.0|-15.1|7.5|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721553|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-6.9|Standard Error of the Mean|6.01||0.2505||95.0|-18.8|4.9|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721554|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-2.4|Standard Error of the Mean|5.76||0.6796||95.0|-13.7|9.0|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721555|NCT00676403|3170347|Superiority or Other||Mean Difference (Final Values)|-6.4|Standard Error of the Mean|5.89||0.2817||95.0|-18.0|5.2|||Mixed Models Analysis|||Week 1: contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721556|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|14.3|Standard Error of the Mean|8.02||0.0757||95.0|-1.5|30.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721557|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|2.4|Standard Error of the Mean|7.82||0.7575||95.0|-13.0|17.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721558|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|10.0|Standard Error of the Mean|8.28||0.23||95.0|-6.3|26.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721559|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|10.3|Standard Error of the Mean|7.77||0.1883||95.0|-5.0|25.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721560|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|17.8|Standard Error of the Mean|8.06||0.0281||95.0|1.9|33.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721561|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|18.9|Standard Error of the Mean|7.96||0.0179||95.0|3.3|34.6|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721562|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|11.0|Standard Error of the Mean|7.77||0.1593||95.0|-4.3|26.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721563|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|9.1|Standard Error of the Mean|8.15||0.2675||95.0|-7.0|25.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722543|NCT00666406|3171640|Superiority or Other||Ratio of the geometric means|1.036|||||2-Sided|90.0|0.857|1.253|||||||
1721564|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|5.2|Standard Error of the Mean|7.66||0.4991||95.0|-9.9|20.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721565|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|8.3|Standard Error of the Mean|7.94||0.2985||95.0|-7.4|23.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721566|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|13.9|Standard Error of the Mean|7.9||0.0804||95.0|-1.7|29.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721567|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|-1.6|Standard Error of the Mean|7.71||0.8336||95.0|-16.8|13.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721568|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|6.3|Standard Error of the Mean|8.1||0.4372||95.0|-9.6|22.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721569|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|4.0|Standard Error of the Mean|7.66||0.5987||95.0|-11.0|19.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721570|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|15.4|Standard Error of the Mean|7.95||0.0541||95.0|-0.3|31.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721571|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|11.0|Standard Error of the Mean|7.77||0.1589||95.0|-4.3|26.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721572|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|4.6|Standard Error of the Mean|7.69||0.5513||95.0|-10.6|19.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721573|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|8.5|Standard Error of the Mean|8.06||0.2905||95.0|-7.3|24.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721574|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|7.71||0.9839||95.0|-15.0|15.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721575|NCT00676403|3170348|Superiority or Other||Mean Difference (Final Values)|10.9|Standard Error of the Mean|7.87||0.1673||95.0|-4.6|26.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721576|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|5.22||0.8824||95.0|-11.0|9.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721577|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|4.4|Standard Error of the Mean|5.07||0.3857||95.0|-5.6|14.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722544|NCT00666406|3171641|Superiority or Other||Ratio of the geometric means|1.135|||||2-Sided|90.0|1.092|1.18|||||||
1721578|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|-4.1|Standard Error of the Mean|5.42||0.4484||95.0|-14.8|6.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721579|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|2.5|Standard Error of the Mean|5.07||0.6183||95.0|-7.4|12.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721580|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|6.5|Standard Error of the Mean|5.26||0.2197||95.0|-3.9|16.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721581|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|0.7|Standard Error of the Mean|5.17||0.8948||95.0|-9.5|10.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721582|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|0.8|Standard Error of the Mean|5.02||0.8784||95.0|-9.1|10.6|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721583|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|5.3||0.9925||95.0|-10.5|10.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721584|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|1.0|Standard Error of the Mean|4.97||0.8439||95.0|-8.8|10.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721585|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|7.4|Standard Error of the Mean|5.15||0.1544||95.0|-2.8|17.5|||Mixed Models Analysis|||Week 4: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721586|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|8.0|Standard Error of the Mean|5.12||0.119||95.0|-2.1|18.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721587|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|0.8|Standard Error of the Mean|4.97||0.8663||95.0|-8.9|10.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721588|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|-3.1|Standard Error of the Mean|5.26||0.5593||95.0|-13.4|7.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721589|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|4.96||0.9538||95.0|-9.5|10.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721590|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|4.8|Standard Error of the Mean|5.17||0.3554||95.0|-5.4|14.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721591|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|8.7|Standard Error of the Mean|5.02||0.0832||95.0|-1.2|18.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722329|NCT00667810|3171330|Superiority or Other||Mean Difference (Final Values)|0.38||||0.725|2-Sided|95.0|-1.76|2.52|||Mixed Models Analysis||||
1721592|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|4.96||0.8037||95.0|-11.0|8.5|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721593|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|-1.9|Standard Error of the Mean|5.24||0.7178||95.0|-12.2|8.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721594|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|2.0|Standard Error of the Mean|5.02||0.693||95.0|-7.9|11.8|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721595|NCT00676403|3170349|Superiority or Other||Mean Difference (Final Values)|5.6|Standard Error of the Mean|5.1||0.2719||95.0|-4.4|15.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721596|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|-5.4|Standard Error of the Mean|7.89||0.4928||95.0|-21.0|10.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721597|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|3.1|Standard Error of the Mean|7.79||0.6892||95.0|-12.2|18.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721598|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|8.31||0.993||95.0|-16.3|16.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721599|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|-4.5|Standard Error of the Mean|7.79||0.5619||95.0|-19.9|10.8|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721600|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|4.6|Standard Error of the Mean|8.02||0.5679||95.0|-11.2|20.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721601|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|7.85||0.9656||95.0|-15.8|15.1|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721602|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|5.9|Standard Error of the Mean|7.75||0.4445||95.0|-9.3|21.2|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721603|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|-4.3|Standard Error of the Mean|8.22||0.6||95.0|-20.5|11.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721604|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|7.71||0.913||95.0|-16.0|14.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721605|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|7.6|Standard Error of the Mean|7.94||0.3392||95.0|-8.0|23.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722545|NCT00666406|3171642|Superiority or Other||Ratio of the geometric means|1.171|||||2-Sided|90.0|1.099|1.247|||||||
1721606|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|-10.7|Standard Error of the Mean|7.81||0.1739||95.0|-26.1|4.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721607|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|7.72||0.8152||95.0|-17.0|13.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721608|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|-7.1|Standard Error of the Mean|8.18||0.3833||95.0|-23.3|9.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721609|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|-9.8|Standard Error of the Mean|7.71||0.2029||95.0|-25.0|5.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721610|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|0.7|Standard Error of the Mean|7.95||0.9336||95.0|-15.0|16.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721611|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|-6.9|Standard Error of the Mean|7.72||0.3746||95.0|-22.1|8.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721612|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|7.7||0.9466||95.0|-15.7|14.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721613|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|3.0|Standard Error of the Mean|8.09||0.7082||95.0|-12.9|19.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721614|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|-6.2|Standard Error of the Mean|7.75||0.4232||95.0|-21.5|9.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721615|NCT00676403|3170350|Superiority or Other||Mean Difference (Final Values)|7.6|Standard Error of the Mean|7.88||0.3368||95.0|-8.0|23.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721616|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-20.9|Standard Error of the Mean|7.0||0.0031||95.0|-34.7|-7.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721617|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-12.1|Standard Error of the Mean|6.92||0.0815||95.0|-25.8|1.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721618|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-14.2|Standard Error of the Mean|7.26||0.0517||95.0|-28.5|0.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721619|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-6.1|Standard Error of the Mean|6.84||0.3739||95.0|-19.6|7.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722546|NCT00666406|3171643|Superiority or Other||Ratio of the geometric means|1.071|||||2-Sided|90.0|0.972|1.179|||||||
1721620|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-9.9|Standard Error of the Mean|7.08||0.1623||95.0|-23.9|4.0|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721621|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-15.4|Standard Error of the Mean|6.97||0.0282||95.0|-29.1|-1.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721622|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-12.2|Standard Error of the Mean|6.89||0.0791||95.0|-25.7|1.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721623|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-10.4|Standard Error of the Mean|7.17||0.1472||95.0|-24.5|3.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721624|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-6.4|Standard Error of the Mean|6.76||0.3488||95.0|-19.7|7.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721625|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|3.5|Standard Error of the Mean|7.0||0.6128||95.0|-10.2|17.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721626|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-16.4|Standard Error of the Mean|6.92||0.0187||95.0|-30.0|-2.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721627|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-19.6|Standard Error of the Mean|6.85||0.0046||95.0|-33.1|-6.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721628|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-10.4|Standard Error of the Mean|7.13||0.1465||95.0|-24.4|3.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721629|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-7.3|Standard Error of the Mean|6.76||0.2806||95.0|-20.6|6.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721630|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-9.4|Standard Error of the Mean|7.01||0.1819||95.0|-23.2|4.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721631|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-17.4|Standard Error of the Mean|6.83||0.0116||95.0|-30.9|-3.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721632|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-8.7|Standard Error of the Mean|6.84||0.2023||95.0|-22.2|4.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721633|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-14.1|Standard Error of the Mean|7.11||0.0492||95.0|-28.1|-0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722547|NCT00666406|3171644|Superiority or Other||Ratio of the geometric means|1.06|||||2-Sided|90.0|0.866|1.297|||||||
1721634|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-12.1|Standard Error of the Mean|6.8||0.0767||95.0|-25.5|1.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721635|NCT00676403|3170351|Superiority or Other||Mean Difference (Final Values)|-9.3|Standard Error of the Mean|6.94||0.1824||95.0|-23.0|4.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721636|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|14.9|Standard Error of the Mean|5.95||0.0131||95.0|3.2|26.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721637|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|9.2|Standard Error of the Mean|5.96||0.1257||95.0|-2.6|20.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721638|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|16.6|Standard Error of the Mean|6.16||0.0076||95.0|4.4|28.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721639|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|9.6|Standard Error of the Mean|5.86||0.1032||95.0|-2.0|21.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721640|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|13.7|Standard Error of the Mean|6.01||0.0241||95.0|1.8|25.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721641|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|16.4|Standard Error of the Mean|5.95||0.0064||95.0|4.7|28.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721642|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|11.2|Standard Error of the Mean|5.96||0.0609||95.0|-0.5|23.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721643|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|16.1|Standard Error of the Mean|6.12||0.0089||95.0|4.1|28.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721644|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|5.2|Standard Error of the Mean|5.84||0.3785||95.0|-6.4|16.7|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721645|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|13.9|Standard Error of the Mean|6.01||0.0215||95.0|2.1|25.8|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721646|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|10.7|Standard Error of the Mean|5.92||0.073||95.0|-1.0|22.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721647|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|11.0|Standard Error of the Mean|5.93||0.0642||95.0|-0.7|22.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722548|NCT00666406|3171645|Superiority or Other||Ratio of the geometric means|1.139|||||2-Sided|90.0|1.043|1.243|||||||
1721648|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|15.0|Standard Error of the Mean|6.06||0.014||95.0|3.1|27.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721649|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|8.8|Standard Error of the Mean|5.81||0.1296||95.0|-2.6|20.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721650|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|10.6|Standard Error of the Mean|5.99||0.0772||95.0|-1.2|22.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721651|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|11.6|Standard Error of the Mean|5.98||0.0537||95.0|-0.2|23.4|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721652|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|9.7|Standard Error of the Mean|5.96||0.1038||95.0|-2.0|21.5|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721653|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|13.0|Standard Error of the Mean|6.09||0.0342||95.0|1.0|25.0|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721654|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|4.7|Standard Error of the Mean|5.84||0.4175||95.0|-6.8|16.2|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721655|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|9.2|Standard Error of the Mean|6.01||0.1267||95.0|-2.6|21.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721656|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|12.8|Standard Error of the Mean|5.83||0.0295||95.0|1.3|24.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721657|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|12.1|Standard Error of the Mean|5.91||0.0415||95.0|0.5|23.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721658|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|12.9|Standard Error of the Mean|6.04||0.0331||95.0|1.1|24.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721659|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|7.5|Standard Error of the Mean|5.81||0.1993||95.0|-4.0|18.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721660|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|12.1|Standard Error of the Mean|5.93||0.0428||95.0|0.4|23.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721661|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|12.2|Standard Error of the Mean|5.8||0.0358||95.0|0.8|23.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722549|NCT00666406|3171646|Superiority or Other||Ratio of the geometric means|1.173|||||2-Sided|90.0|1.089|1.262|||||||
1721662|NCT00676403|3170352|Superiority or Other||Median Difference (Final Values)|6.6|Standard Error of the Mean|5.88||0.2643||95.0|-5.0|18.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721663|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|11.0|Standard Error of the Mean|5.91||0.0642||95.0|-0.7|22.6|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721664|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|10.3|Standard Error of the Mean|5.78||0.0768||95.0|-1.1|21.7|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721665|NCT00676403|3170352|Superiority or Other||Mean Difference (Final Values)|13.8|Standard Error of the Mean|5.89||0.0199||95.0|2.2|25.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721666|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-21.3|Standard Error of the Mean|10.98||0.0534||95.0|-42.9|0.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721667|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-6.9|Standard Error of the Mean|10.83||0.5216||95.0|-28.3|14.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721668|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-19.8|Standard Error of the Mean|11.41||0.0839||95.0|-42.3|2.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721669|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|10.73||0.9962||95.0|-21.2|21.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721670|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-22.8|Standard Error of the Mean|10.98||0.0388||95.0|-44.4|-1.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721671|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-26.4|Standard Error of the Mean|10.9||0.0159||95.0|-47.9|-5.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721672|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-13.8|Standard Error of the Mean|10.76||0.1997||95.0|-35.0|7.4|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721673|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-30.9|Standard Error of the Mean|11.31||0.0067||95.0|-53.2|-8.6|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721674|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-2.0|Standard Error of the Mean|10.67||0.8506||95.0|-23.0|19.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721675|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-26.8|Standard Error of the Mean|11.06||0.0161||95.0|-48.5|-5.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722661|NCT00664534|3171929|Superiority or Other|||||||0.6169||||||P-value for Week 32|Wilcoxon (Mann-Whitney)||||
1721676|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-16.5|Standard Error of the Mean|10.84||0.1293||95.0|-37.8|4.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721677|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-13.2|Standard Error of the Mean|10.77||0.2209||95.0|-34.4|8.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721678|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-15.6|Standard Error of the Mean|11.16||0.1634||95.0|-37.6|6.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721679|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-6.1|Standard Error of the Mean|10.61||0.5651||95.0|-27.0|14.8|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721680|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-20.4|Standard Error of the Mean|10.99||0.0647||95.0|-42.0|1.2|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721681|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-8.6|Standard Error of the Mean|10.97||0.4338||95.0|-30.2|13.0|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721682|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-8.0|Standard Error of the Mean|10.77||0.4595||95.0|-29.2|13.2|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721683|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-11.6|Standard Error of the Mean|11.22||0.3039||95.0|-33.6|10.5|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721684|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|2.3|Standard Error of the Mean|10.67||0.8302||95.0|-18.7|23.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721685|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-17.1|Standard Error of the Mean|11.06||0.1237||95.0|-38.8|4.7|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721686|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-16.8|Standard Error of the Mean|10.61||0.1142||95.0|-37.7|4.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721687|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-10.3|Standard Error of the Mean|10.7||0.3347||95.0|-31.4|10.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721688|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-12.5|Standard Error of the Mean|11.1||0.262||95.0|-34.3|9.4|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721689|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-7.0|Standard Error of the Mean|10.6||0.5084||95.0|-27.9|13.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722662|NCT00664534|3171929|Superiority or Other|||||||0.9798||||||P-value is for Week 16|Wilcoxon (Mann-Whitney)||||
1721690|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-17.6|Standard Error of the Mean|10.77||0.1041||95.0|-38.8|3.6|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721691|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-8.8|Standard Error of the Mean|10.54||0.4023||95.0|-29.6|11.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721692|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-8.5|Standard Error of the Mean|10.63||0.4266||95.0|-29.4|12.5|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721693|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-5.3|Standard Error of the Mean|10.79||0.6263||95.0|-26.5|16.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721694|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-4.7|Standard Error of the Mean|10.54||0.653||95.0|-25.5|16.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721695|NCT00676403|3170353|Superiority or Other||Mean Difference (Final Values)|-14.2|Standard Error of the Mean|10.68||0.186||95.0|-35.2|6.9|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721696|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.31||0.4072||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721697|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.3||0.9136||95.0|-0.6|0.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721698|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.31||0.1271||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721699|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.3||0.6877||95.0|-0.7|0.5|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721700|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.31||0.9505||95.0|-0.6|0.6|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721701|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.31||0.0262||95.0|-1.3|-0.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721702|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.3||0.1721||95.0|-1.0|0.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721703|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.31||0.0091||95.0|-1.4|-0.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722330|NCT00667810|3171330|Superiority or Other||Mean Difference (Final Values)|-1.32||||0.212|2-Sided|95.0|-3.4|0.76|||Mixed Models Analysis||||
1721704|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.3||0.4741||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721705|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.31||0.1152||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721706|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.3||0.3631||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721707|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.3||0.4362||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721708|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.31||0.0554||95.0|-1.2|0.0|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721709|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.3||0.348||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721710|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.31||0.5754||95.0|-0.8|0.4|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721711|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.31||0.022||95.0|-1.3|-0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721712|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.3||0.1335||95.0|-1.0|0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721713|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.31||0.0753||95.0|-1.2|0.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721714|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.3||0.2686||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721715|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.31||0.3728||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721716|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.3||0.225||95.0|-1.0|0.2|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721717|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.3||0.0675||95.0|-1.1|0.0|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722075|NCT00673465|3170666|Superiority or Other||Difference in least squares mean|-3.59|||<|0.3146|2-Sided|95.0|-10.8|3.6|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.|||
1721718|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.31||0.0844||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721719|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.3||0.0895||95.0|-1.1|0.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721720|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.3||0.3435||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721721|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.3||0.2959||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721722|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.3||0.3676||95.0|-0.9|0.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721723|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.3||0.0095||95.0|-1.4|-0.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721724|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.3||0.0547||95.0|-1.2|0.0|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721725|NCT00676403|3170354|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.3||0.1429||95.0|-1.0|0.1|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721726|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.92|Standard Error of the Mean|0.26||0.0005||95.0|0.41|1.43|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721727|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.256||0.3258||95.0|-0.25|0.76|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721728|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.75|Standard Error of the Mean|0.269||0.0053||95.0|0.23|1.28|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721729|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.256||0.382||95.0|-0.28|0.73|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721730|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.65|Standard Error of the Mean|0.261||0.0133||95.0|0.14|1.17|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721731|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|1.06|Standard Error of the Mean|0.26||0.0001||95.0|0.55|1.57|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722076|NCT00673465|3170668|Superiority or Other||Difference in least squares mean|-63.6|||<|0.0001|2-Sided|95.0|-80.9|-46.2|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.|||
1721732|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.256||0.3383||95.0|-0.26|0.75|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721733|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.267||0.0249||95.0|0.08|1.13|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721734|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.254||0.8021||95.0|-0.44|0.56|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721735|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.66|Standard Error of the Mean|0.261||0.0125||95.0|0.14|1.17|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721736|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.76|Standard Error of the Mean|0.259||0.0035||95.0|0.25|1.27|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721737|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.37|Standard Error of the Mean|0.254||0.1423||95.0|-0.13|0.87|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721738|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.65|Standard Error of the Mean|0.263||0.0135||95.0|0.14|1.17|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721739|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.253||0.4495||95.0|-0.31|0.69|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721740|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.54|Standard Error of the Mean|0.26||0.0383||95.0|0.03|1.05|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721741|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.96|Standard Error of the Mean|0.262||0.0003||95.0|0.45|1.48|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721742|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.36|Standard Error of the Mean|0.256||0.1622||95.0|-0.15|0.86|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721743|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.53|Standard Error of the Mean|0.265||0.0453||95.0|0.01|1.05|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721744|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.254||0.5079||95.0|-0.33|0.67|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721745|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.261||0.3389||95.0|-0.26|0.76|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722077|NCT00673465|3170668|Superiority or Other||Difference in least squares mean|-2.81|||<|0.741|2-Sided|95.0|-20.1|14.5|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.|||
1721746|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.71|Standard Error of the Mean|0.253||0.0054||95.0|0.21|1.21|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721747|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.253||0.1146||95.0|-0.1|0.9|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721748|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.46|Standard Error of the Mean|0.262||0.0817||95.0|-0.06|0.97|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721749|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.252||0.5191||95.0|-0.33|0.66|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721750|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.256||0.2501||95.0|-0.21|0.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721751|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.251||0.0481||95.0|0.0|0.99|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721752|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.251||0.3652||95.0|-0.27|0.72|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721753|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.255||0.1994||95.0|-0.17|0.83|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721754|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.251||0.7944||95.0|-0.43|0.56|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721755|NCT00676403|3170355|Superiority or Other||Mean Difference (Final Values)|0.35|Standard Error of the Mean|0.254||0.1715||95.0|-0.15|0.85|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score is included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721756|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-22.5|Standard Error of the Mean|8.16||0.0063||95.0|-38.6|-6.4|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721757|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|2.3|Standard Error of the Mean|8.09||0.7723||95.0|-13.6|18.3|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721758|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-12.7|Standard Error of the Mean|8.39||0.1329||95.0|-29.2|3.9|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721759|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-7.1|Standard Error of the Mean|8.04||0.3791||95.0|-22.9|8.7|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722260|NCT00670488|3171024|Other||AUC0-168hr GMR|1.91||||||||||||||The Last Day/Day 1 AUC 0-168 hr GMR was calculated as follows: Last Day AUC 0-168hr GM ÷ Day 1 AUC 0-48hr GM.|
1721760|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-13.0|Standard Error of the Mean|8.22||0.1157||95.0|-29.2|3.2|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721761|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-20.3|Standard Error of the Mean|8.16||0.0137||95.0|-36.3|-4.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721762|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|2.5|Standard Error of the Mean|8.09||0.7552||95.0|-13.4|18.5|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721763|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-8.1|Standard Error of the Mean|8.34||0.3319||95.0|-24.5|8.3|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721764|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|8.0||0.8269||95.0|-17.5|14.0|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721765|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-10.9|Standard Error of the Mean|8.22||0.1842||95.0|-27.1|5.2|||Mixed Models Analysis|||Week 5: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721766|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-23.5|Standard Error of the Mean|8.13||0.0041||95.0|-39.6|-7.5|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721767|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-4.6|Standard Error of the Mean|8.06||0.5665||95.0|-20.5|11.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721768|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-4.6|Standard Error of the Mean|8.25||0.5776||95.0|-20.9|11.7|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721769|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-6.8|Standard Error of the Mean|7.96||0.3958||95.0|-22.5|8.9|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721770|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-6.8|Standard Error of the Mean|8.18||0.4084||95.0|-22.9|9.3|||Mixed Models Analysis|||Week 4: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721771|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-19.1|Standard Error of the Mean|8.21||0.0209||95.0|-35.2|-2.9|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721772|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-3.2|Standard Error of the Mean|8.09||0.6895||95.0|-19.2|12.7|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721773|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-3.2|Standard Error of the Mean|8.29||0.6973||95.0|-19.6|13.1|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722315|NCT00667810|3171321|Superiority or Other|||||||0.423|||||||Cochran-Mantel-Haenszel||||
1721774|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|1.5|Standard Error of the Mean|8.0||0.8527||95.0|-14.3|17.3|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721775|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-4.3|Standard Error of the Mean|8.22||0.5976||95.0|-20.5|11.8|||Mixed Models Analysis|||Week 3: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721776|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-25.5|Standard Error of the Mean|7.99||0.0016||95.0|-41.2|-9.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721777|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-4.1|Standard Error of the Mean|8.02||0.6079||95.0|-19.9|11.7|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721778|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-7.4|Standard Error of the Mean|8.22||0.3686||95.0|-23.6|8.8|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721779|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-8.4|Standard Error of the Mean|7.96||0.2946||95.0|-24.0|7.3|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721780|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-11.9|Standard Error of the Mean|8.1||0.1443||95.0|-27.8|4.1|||Mixed Models Analysis|||Week 2: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721781|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-10.5|Standard Error of the Mean|7.94||0.1895||95.0|-26.1|5.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721782|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|7.97||0.9355||95.0|-15.1|16.4|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721783|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|8.04||0.9355||95.0|-16.5|15.2|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721784|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-3.4|Standard Error of the Mean|7.92||0.6676||95.0|-19.0|12.2|||Mixed Models Analysis|||Week 1: Conrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721785|NCT00676403|3170356|Superiority or Other||Mean Difference (Final Values)|-6.6|Standard Error of the Mean|8.05||0.4133||95.0|-22.4|9.3|||Mixed Models Analysis|||Week 1: Contrast of treatment vs. placebo. Repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, the model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721786|NCT00676403|3170357|Superiority or Other|||||||0.0133|||||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721787|NCT00676403|3170357|Superiority or Other|||||||0.6357|||||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721788|NCT00676403|3170357|Superiority or Other|||||||0.1563|||||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721789|NCT00676403|3170357|Superiority or Other|||||||0.3936|||||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1722316|NCT00667810|3171321|Superiority or Other|||||||0.855|||||||Cochran-Mantel-Haenszel||||
1722317|NCT00667810|3171323|Superiority or Other|||||||0.996|||||||Cochran-Mantel-Haenszel||||
1721790|NCT00676403|3170357|Superiority or Other|||||||0.9748|||||||Cochran-Mantel-Haenszel|||Last Observation Carried Forward: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721791|NCT00676403|3170357|Superiority or Other|||||||0.009|||||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721792|NCT00676403|3170357|Superiority or Other|||||||0.5381|||||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721793|NCT00676403|3170357|Superiority or Other|||||||0.0806|||||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721794|NCT00676403|3170357|Superiority or Other|||||||0.3656|||||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721795|NCT00676403|3170357|Superiority or Other|||||||0.8662|||||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721796|NCT00676403|3170357|Superiority or Other|||||||0.0043|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721797|NCT00676403|3170357|Superiority or Other|||||||0.5687|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721798|NCT00676403|3170357|Superiority or Other|||||||0.2823|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721799|NCT00676403|3170357|Superiority or Other|||||||0.6668|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721800|NCT00676403|3170357|Superiority or Other|||||||0.9835|||||||Cochran-Mantel-Haenszel|||Week 4: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721801|NCT00676403|3170357|Superiority or Other|||||||0.0053|||||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721802|NCT00676403|3170357|Superiority or Other|||||||0.3509|||||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721803|NCT00676403|3170357|Superiority or Other|||||||0.3219|||||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721804|NCT00676403|3170357|Superiority or Other|||||||0.6524|||||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721805|NCT00676403|3170357|Superiority or Other|||||||0.41|||||||Cochran-Mantel-Haenszel|||Week 2: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721806|NCT00676403|3170357|Superiority or Other|||||||0.0551|||||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721807|NCT00676403|3170357|Superiority or Other|||||||0.7032|||||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721808|NCT00676403|3170357|Superiority or Other|||||||0.2032|||||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721809|NCT00676403|3170357|Superiority or Other|||||||0.7959|||||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721810|NCT00676403|3170357|Superiority or Other|||||||0.3876|||||||Cochran-Mantel-Haenszel|||Week 1: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721811|NCT00676403|3170358|Superiority or Other|||||||0.0466|||||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721812|NCT00676403|3170358|Superiority or Other|||||||0.9505|||||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721813|NCT00676403|3170358|Superiority or Other|||||||0.8955|||||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721814|NCT00676403|3170358|Superiority or Other|||||||0.6767|||||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721815|NCT00676403|3170358|Superiority or Other|||||||0.8784|||||||Cochran-Mantel-Haenszel|||Week 6: Cochran-Mantel-Haenszel test for difference; p-value was adjusted for geographic region at each visit.|
1721816|NCT00676403|3170359|Superiority or Other||Mean Difference (Final Values)|-8.53|Standard Error of the Mean|2.469||0.0006||95.0|-13.4|-3.67|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721817|NCT00676403|3170359|Superiority or Other||Mean Difference (Final Values)|-5.16|Standard Error of the Mean|2.437||0.0353||95.0|-9.96|-0.36|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721818|NCT00676403|3170359|Superiority or Other||Mean Difference (Final Values)|-8.29|Standard Error of the Mean|2.548||0.0013||95.0|-13.31|-3.28|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1722078|NCT00673465|3170672|Superiority or Other||Difference in least squares mean|-53.9|||<|0.0001|2-Sided|95.0|-68.1|-39.8|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.|||
1721819|NCT00676403|3170359|Superiority or Other||Mean Difference (Final Values)|-4.03|Standard Error of the Mean|2.415||0.0966||95.0|-8.78|0.73|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721820|NCT00676403|3170359|Superiority or Other||Mean Difference (Final Values)|-4.1|Standard Error of the Mean|2.472||0.0983||95.0|-8.97|0.77|||Mixed Models Analysis|||Week 6: Contrast of treatment vs. placebo. The repeated measures model used fixed effects of treatment, geographic region, week and treatment by week interaction. Baseline score was included as a covariate. Additionally, model includes subject as a repeated measurement block within which the covariance structure is assumed to be compound symmetric (CS).|
1721821|NCT00676403|3170359|Superiority or Other||Median Difference (Final Values)|123.9||||||95.0|0.4|523.9|||||Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED90 distribution or confidence interval.|Dose response analysis ED 90: dose providing 90% of the maximal effect. Statistics were obtained from three parameter model Y = D + G*exp(B*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.|
1721822|NCT00676403|3170359|Superiority or Other||Median Difference (Final Values)|37.3||||||95.0|0.1|157.7|||||Non-convergence for the non-liner model occurred in some bootstrap samples which were not included in summarizing the ED50 distribution or confidence interval.|Dose response analysis ED 50: dose providing 50% of the maximal effect. Statistics were obtained from three parameter model Y = D + G*exp(B*dose) by bootstrapping 2000 data sets, where D = expected response of saturation (maximal effect), B = related to slope of the dose response mechanism (change in response relative to the change in dose), and D+G = expected response at zero dose.|
1721823|NCT00676364|3170360|Non-Inferiority or Equivalence|We determined that we will need to enroll 43 children in each group, for a power of .80, alpha=0.05. We used a per protocol analysis.|Mean Difference (Final Values)|2.1||||0.71|||||||Chi-squared||To assess the association between pain and anxiety with intervention group while controlling for other factors, linear regression was used.|P-value determined from linear regression models that include age, gender, number of needle sticks in previous 2 years and nurse reported difficulty in performing venipuncture.|
1721824|NCT00676338|3170362|Superiority or Other||Least Squares Mean Difference|-0.05|Standard Error of the Mean|0.79||0.946|2-Sided|95.0|-1.6|1.49||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721825|NCT00676338|3170362|Superiority or Other||Least Squares Mean Difference|2.0|Standard Error of the Mean|0.8||0.013|2-Sided|95.0|0.43|3.58||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721826|NCT00676338|3170362|Superiority or Other||Least Squares Mean Difference|0.36|Standard Error of the Mean|0.7||0.61|2-Sided|95.0|-1.02|1.73||No multiple adjustment were done.|Mixed Models Analysis|||Change in Diastolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline diastolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721827|NCT00676338|3170363|Superiority or Other||Least Squares Mean Difference|0.56|Standard Error of the Mean|1.22||0.646|2-Sided|95.0|-1.84|2.96||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721828|NCT00676338|3170363|Superiority or Other||Least Squares Mean Difference|0.49|Standard Error of the Mean|1.24||0.693|2-Sided|95.0|-1.94|2.93||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721829|NCT00676338|3170363|Superiority or Other||Least Squares Mean Difference|-1.39|Standard Error of the Mean|1.09||0.201|2-Sided|95.0|-3.52|0.74||No multiple adjustment were done.|Mixed Models Analysis|||Change in Systolic Blood Pressure from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline systolic blood pressure, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721830|NCT00676338|3170366|Superiority or Other||Geometric Least Squares Mean Ratio|1.04|Standard Error of the Mean|0.05||0.398|2-Sided|95.0|0.95|1.14||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.|
1721831|NCT00676338|3170366|Superiority or Other||Geometric Least Squares Mean Ratio|1.16|Standard Error of the Mean|0.05||0.002|2-Sided|95.0|1.06|1.27||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.|
1721832|NCT00676338|3170366|Superiority or Other||Geometric Least Squares Mean Ratio|1.02|Standard Error of the Mean|0.04||0.657|2-Sided|95.0|0.94|1.1||No multiple adjustment were done.|ANCOVA|||Fasting triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed using ANCOVA model with treatment and country as factors and baseline triglycerides as a covariate.|
1721887|NCT00676052|3170423|Superiority||Mean Difference (Net)|0.244|||<|0.001|2-Sided|95.0|0.172|0.315||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1|
1721833|NCT00676338|3170367|Superiority or Other||Least Squares Mean Difference|-0.03|Standard Error of the Mean|0.02||0.142|2-Sided|95.0|-0.07|0.01||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721834|NCT00676338|3170367|Superiority or Other||Least Squares Mean Difference|-0.15|Standard Error of the Mean|0.02|<|0.001|2-Sided|95.0|-0.19|-0.11||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721835|NCT00676338|3170367|Superiority or Other||Least Squares Mean Difference|-0.05|Standard Error of the Mean|0.02|<|0.004|2-Sided|95.0|-0.09|-0.02||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting HDL from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline HDL, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721836|NCT00676338|3170368|Superiority or Other||Least Squares Mean Difference|-0.22|Standard Error of the Mean|0.1||0.022|2-Sided|95.0|-0.41|-0.03||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721837|NCT00676338|3170368|Superiority or Other||Least Squares Mean Difference|-0.33|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.52|-0.14||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721838|NCT00676338|3170368|Superiority or Other||Least Squares Mean Difference|-0.01|Standard Error of the Mean|0.08|<|0.873|2-Sided|95.0|-0.18|0.15||No multiple adjustment were done.|Mixed Models Analysis|||Change in Fasting TC from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline TC, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721839|NCT00676338|3170369|Superiority or Other||Least Squares Mean Difference|-1.28|Standard Error of the Mean|0.33|<|0.001|2-Sided|95.0|-1.92|-0.63||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721840|NCT00676338|3170369|Superiority or Other||Least Squares Mean Difference|-3.56|Standard Error of the Mean|0.33|<|0.001|2-Sided|95.0|-4.21|-2.9||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721841|NCT00676338|3170369|Superiority or Other||Least Squares Mean Difference|-0.04|Standard Error of the Mean|0.29|<|0.892|2-Sided|95.0|-0.61|0.53||No multiple adjustment were done.|Mixed Models Analysis|||Change in Body Weight from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline body weight, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721842|NCT00676338|3170370|Superiority or Other||Least Squares Mean Difference|-1.12|Standard Error of the Mean|0.22|<|0.001|2-Sided|95.0|-1.56|-0.68||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721843|NCT00676338|3170370|Superiority or Other||Least Squares Mean Difference|0.32|Standard Error of the Mean|0.22|<|0.153|2-Sided|95.0|-0.12|0.75||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721844|NCT00676338|3170370|Superiority or Other||Least Squares Mean Difference|-0.28|Standard Error of the Mean|0.19|<|0.155|2-Sided|95.0|-0.66|0.1||No multiple adjustment were done.|Mixed Models Analysis|||Change in FSG from baseline to Week 26 was analyzed using an MMRM ANCOVA model with treatment, baseline FSG, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|
1721845|NCT00676338|3170371|Superiority or Other||||||<|0.001||||||No multiple adjustment were done.|Fisher Exact||||
1721846|NCT00676338|3170371|Superiority or Other||||||<|0.913||||||No multiple adjustment were done.|Fisher Exact||||
1721847|NCT00676338|3170371|Superiority or Other||||||<|0.151||||||No multiple adjustment were done.|Fisher Exact||||
1721848|NCT00676338|3170372|Non-Inferiority or Equivalence|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|-0.37|Standard Error of the Mean|0.1|<|0.001|2-Sided|98.3|-0.62|-0.13||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.|
1721869|NCT00676130|3170406|Superiority or Other||Risk Difference (RD)|2.7|||<|0.05||95.0|-9.3|15.0|||Chi-squared|||The study was powered to detect a difference in cure rate of 98% in the intervention group vs. 85% in the control group, with 2-sided alpha 0.05. This would yield a number needed to treat of 7.7 for intervention vs. control, and required 144 subjects to achieve 80% power. No data were analyzed until study completion.|
1721849|NCT00676338|3170372|Non-Inferiority or Equivalence|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|0.1|Standard Error of the Mean|0.1|<|0.328|2-Sided|98.3|-0.15|0.35||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.|
1721850|NCT00676338|3170372|Non-Inferiority or Equivalence|Noninferiority Null Hypotheses: H1: The effect of exenatide is inferior to that of metformin. H2: The effect of exenatide is inferior to that of sitagliptin. H3: The effect of exenatide is inferior to that of pioglitazone. Then, the 3 superiority null hypotheses were tested. Change in HbA1c was analyzed using an MMRM analysis of covariance (ANCOVA) with treatment, baseline HbA1c, country, week of visit, and treatment-by week interaction as fixed effects; and patient and error as random effects.|Least Squares Mean Difference|-0.05|Standard Error of the Mean|0.09|<|0.62|2-Sided|98.3|-0.26|0.17||Noninferiority was tested by Bonferroni (margin 0.3%, adjusted significance of 0.0167). Superiority was tested by Hommel (nominal significance level was between 0.0167 and 0.05 depended on the number of noninferiority hypotheses rejected).|Mixed Models Analysis|||Power calculation: A sample of 740 (222 exenatide once weekly, 222 metformin, 148 pioglitazone, and 148 sitagliptin) would provide approximately 90% power to detect a true differences between exenatide once weekly and the 3 comparators: metformin, pioglitazone, and sitagliptin of 0.4%, 0.5%, and 0.5%, respectively in change in HbA1c from baseline to Week 26 with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.|
1721851|NCT00676208|3170373|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1721852|NCT00676208|3170374|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1721853|NCT00676143|3170388|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.448|2-Sided|95.0|-0.55|0.24|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.|
1721854|NCT00676143|3170389|Superiority or Other|||||||0.12|||||||Cochran-Mantel-Haenszel||||
1721855|NCT00676143|3170391|Superiority or Other|||||||0.086|||||||Cochran-Mantel-Haenszel||||
1721856|NCT00676143|3170393|Superiority or Other||Mean Difference (Final Values)|-0.11||||0.462|2-Sided|95.0|-0.41|0.13|||Mixed Models Analysis|||Change in DS total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.|
1721857|NCT00676143|3170394|Superiority or Other|||||||0.478|||||||Log Rank||||
1721858|NCT00676143|3170395|Superiority or Other|||||||0.191|||||||Log Rank||||
1721859|NCT00676143|3170396|Superiority or Other|||||||0.383|||||||Log Rank||||
1721860|NCT00676143|3170397|Superiority or Other|||||||0.684|||||||Log Rank||||
1721861|NCT00676143|3170398|Superiority or Other||Mean Difference (Final Values)|0.09||||0.949|2-Sided|95.0|-2.61|2.78|||Mixed Models Analysis|||Treatment Difference: Bapineuzumab - Placebo|
1721862|NCT00676143|3170399|Superiority or Other||Mean Difference (Final Values)|0.24||||0.7|2-Sided|95.0|-0.97|1.45|||Mixed Models Analysis|||Treatment Difference: Bapineuzumab - Placebo|
1721863|NCT00676143|3170400|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.884|2-Sided|95.0|-1.89|1.63|||Mixed Models Analysis|||"Change in MRI BBSI was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants gave 90% power to detect a 4.15-cm3 advantage for the bapineuzumab group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05."|
1721864|NCT00676143|3170401|Superiority or Other||Mean Difference (Final Values)|-1.38||||0.62|2-Sided|95.0|-6.89|4.13|||ANCOVA|||Change in CSF phospho-tau was analyzed using an analysis of covariance (ANCOVA) model. The analysis was based on the treatment difference estimated at Week 71 based on appropriate contrasts or LS means. The number of participants gave 90% power to detect a 13-ng/L advantage in phospho-tau for the bapineuzumab group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05.|
1721865|NCT00676143|3170402|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.159|2-Sided|95.0|-0.17|0.03|||Mixed Models Analysis|||"Change in PIB PET SUVr was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants gave 90% power to detect a 0.152 unit advantage for the bapineuzumab group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05."|
1721866|NCT00676143|3170403|Superiority or Other||Mean Difference (Final Values)|0.04||||0.973|2-Sided|95.0|-2.51|2.6||Primary variable DAD total score had to reach statistical significance, p-values had to reach p <=0.05, in order to be declared effective.|Mixed Models Analysis|||"Change in DAD total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants in each group gave 90% power to detect a 5.39 unit advantage for the bapineuzumab group over placebo on the DAD total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05."|
1721867|NCT00676143|3170404|Superiority or Other||Mean Difference (Final Values)|0.02||||0.979|2-Sided|95.0|-1.18|1.22||Primary variable ADAS-Cog/11 total score had to reach statistical significance, p-values had to reach p <=0.05, in order to be declared effective.|Mixed Models Analysis|||"Change in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.~The number of participants in each group gave 90% power to detect a 2.21 point advantage for the bapineuzumab group over placebo on the ADAS-Cog/11 total score, at the primary time point (Week 78). This calculation was based on a two-sided test with an alpha of 0.05."|
1721868|NCT00676130|3170405|Superiority or Other||Risk Difference (RD)|0.0|||<|0.05|2-Sided|95.0|-6.5|6.3|||Chi-squared|||We assessed the rate of progression to abscess in the two groups.|
1721870|NCT00676065|3170419|Non-Inferiority or Equivalence|The LASS study was designed to analyse rare events (incidence rate <1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|1.0|||||2-Sided|95.0|0.6|1.5|||||Hazard ratio was adjusted for age, BMI, smoking, educational level and age at menarche.|Tested null hypotheses: the breast cancer hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.|
1721871|NCT00676065|3170419|Non-Inferiority or Equivalence|The LASS study was designed to analyse rare events (incidence rate <1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.9|||||2-Sided|95.0|0.5|1.4|||||Hazard ratio was adjusted for age, BMI, smoking, educational level and age at menarche.|Tested null hypotheses: the breast cancer hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.|
1721872|NCT00676065|3170420|Non-Inferiority or Equivalence|The LASS study was designed to analyse rare events (incidence rate <1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.7|||||2-Sided|95.0|0.5|1.0|||||Hazard ratio was adjusted for age, BMI, current duration of use, and family history of VTE.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.|
1721873|NCT00676065|3170420|Non-Inferiority or Equivalence|The LASS study was designed to analyse rare events (incidence rate <1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|1.1|||||2-Sided|95.0|0.8|1.7|||||Hazard ratio was adjusted for age, BMI, current duration of use, and family history of VTE.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.|
1721874|NCT00676065|3170421|Non-Inferiority or Equivalence|The LASS study was designed to analyse rare events (incidence rate <1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.4|||||2-Sided|95.0|0.2|0.9|||||Hazard ratio was adjusted for age, BMI, smoking, hypertension and family history|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. OCs containing other progestogens is higher or equal to 2.|
1721875|NCT00676065|3170421|Non-Inferiority or Equivalence|The LASS study was designed to analyse rare events (incidence rate <1 per 1,000 woman-years and ≥ 1 per 10,000 WY). 300,000 WY of observation would be sufficient to exclude a two-fold risk of rare events in users of DRSP compared to other oral contraceptives with a power (1-β) of 0.80 and an one-sided α of 0.05.|Hazard Ratio (HR)|0.4|||||2-Sided|95.0|0.2|0.9|||||Hazard ratio was adjusted for age, BMI, smoking, hypertension and family history|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. OCs containing LNG is higher or equal to 2.|
1721876|NCT00676052|3170422|Superiority||Mean Difference (Net)|0.235|||<|0.001|2-Sided|95.0|0.152|0.319||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model||||
1721877|NCT00676052|3170422|Superiority||Mean Difference (Net)|0.163|||<|0.001|2-Sided|95.0|0.08|0.247||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model||||
1721878|NCT00676052|3170422|Superiority||Mean Difference (Net)|0.094|||<|0.026|2-Sided|95.0|0.011|0.177||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model||||
1721879|NCT00676052|3170422|Superiority||Mean Difference (Net)|0.15|||<|0.001|2-Sided|95.0|0.067|0.233||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model||||
1721880|NCT00676052|3170422|Superiority||Mean Difference (Net)|0.099|||<|0.021|2-Sided|95.0|0.015|0.182||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model||||
1721881|NCT00676052|3170423|Superiority||Mean Difference (Net)|0.294|||<|0.001|2-Sided|95.0|0.214|0.373||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28|
1721882|NCT00676052|3170423|Superiority||Mean Difference (Net)|0.232|||<|0.001|2-Sided|95.0|0.152|0.312||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28|
1721883|NCT00676052|3170423|Superiority||Mean Difference (Net)|0.191|||<|0.001|2-Sided|95.0|0.111|0.27||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28|
1721884|NCT00676052|3170423|Superiority||Mean Difference (Net)|0.219|||<|0.001|2-Sided|95.0|0.139|0.298||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28|
1721885|NCT00676052|3170423|Superiority||Mean Difference (Net)|0.178|||<|0.001|2-Sided|95.0|0.098|0.258||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 28|
1721886|NCT00676052|3170423|Superiority||Mean Difference (Net)|0.301|||<|0.001|2-Sided|95.0|0.229|0.372||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1|
1721888|NCT00676052|3170423|Superiority||Mean Difference (Net)|0.198|||<|0.001|2-Sided|95.0|0.127|0.268||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1|
1721889|NCT00676052|3170423|Superiority||Mean Difference (Net)|0.186|||<|0.001|2-Sided|95.0|0.115|0.258||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1|
1721890|NCT00676052|3170423|Superiority||Mean Difference (Net)|0.166|||<|0.001|2-Sided|95.0|0.094|0.237||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||Day 1|
1721891|NCT00676052|3170424|Superiority||Mean Difference (Net)|0.17|||<|0.001|2-Sided|95.0|0.12|0.22||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 28|
1721892|NCT00676052|3170424|Superiority||Mean Difference (Net)|0.142|||<|0.001|2-Sided|95.0|0.092|0.193||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 28|
1721893|NCT00676052|3170424|Superiority||Mean Difference (Net)|0.124|||<|0.001|2-Sided|95.0|0.074|0.174||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 28|
1721894|NCT00676052|3170424|Superiority||Mean Difference (Net)|0.142|||<|0.001|2-Sided|95.0|0.092|0.192||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV, Day 28|
1721895|NCT00676052|3170424|Superiority||Mean Difference (Net)|0.106|||<|0.001|2-Sided|95.0|0.056|0.157||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 28|
1721896|NCT00676052|3170424|Superiority||Mean Difference (Net)|0.176|||<|0.001|2-Sided|95.0|0.135|0.216||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 1|
1721897|NCT00676052|3170424|Superiority||Mean Difference (Net)|0.152|||<|0.001|2-Sided|95.0|0.112|0.193||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1|
1721898|NCT00676052|3170424|Superiority||Mean Difference (Net)|0.123|||<|0.001|2-Sided|95.0|0.083|0.163||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions.|Repeated Measures Model|||FEV1, Day 1|
1721899|NCT00676052|3170424|Superiority||Mean Difference (Net)|0.107|||<|0.001|2-Sided|95.0|0.067|0.147||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1|
1721900|NCT00676052|3170424|Superiority||Mean Difference (Net)|0.106|||<|0.001|2-Sided|95.0|0.065|0.146||Analysis performed using repeated measures with covariates of Baseline, sex, age, smoking status, responsiveness stratum, Day (nominal), treatment and Day by treatment and Day by Baseline interactions|Repeated Measures Model|||FEV1, Day 1|
1721901|NCT00676052|3170425|Superiority||Mean Difference (Net)|0.137|||<|0.001|2-Sided|95.0|0.086|0.187||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA||||
1721902|NCT00676052|3170425|Superiority||Mean Difference (Net)|0.082|||<|0.001|2-Sided|95.0|0.032|0.132||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA||||
1721903|NCT00676052|3170425|Superiority||Mean Difference (Net)|0.069|||<|0.007|2-Sided|95.0|0.019|0.118||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA||||
1721904|NCT00676052|3170425|Superiority||Mean Difference (Net)|0.097|||<|0.001|2-Sided|95.0|0.047|0.147||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA||||
1721905|NCT00676052|3170425|Superiority||Mean Difference (Net)|0.067|||<|0.009|2-Sided|95.0|0.017|0.117||Analysis performed using ANCOVA with covariates of Baseline, sex, age, smoking status, responsiveness stratum and treatment. Missing trough FEV1 data at Day 29 was imputed using LOCF.|ANCOVA||||
1721906|NCT00676013|3170427|Other|ANOVA and all pairwise comparisons using Tukey test.|Multiple pairwise comparisons|0.05||||0.05|2-Sided|||||0.05 is a threshold for statistical significance.|ANOVA|||We conducted a multiple four group comparison (all pairwise comparisons were conducted). An Anova was conducted to assess statistical significance.|0.05
1721907|NCT00675766|3170453|Superiority or Other|||||||0.044|||||||Fisher Exact|One-sided Fisher's exact test with 1 degree of freedom.||Fisher's exact test compared the frequency of older and younger HIV+ adults who converted from neurocognitively intact to neurocognitively impaired on memory over a one year time period. We hypothesized that the older group would exhibit a greater proportion of individuals who declined during this interim.|
1721908|NCT00675766|3170453|Superiority or Other|||||||0.79|||||||Repeated Measures ANOVA|Range of z-scores at baseline: -4.04 to 1.33. Range of z-scores at Year 1 follow-up: -1.24 to 2.37.||Repeated Measures ANOVA with motor skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing fine motor speed and dexterity, across time as the within-group factor and HIV serostatus and age group as between-group factors.|
1722070|NCT00673660|3170655|Superiority or Other|||||||0.034||||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||Triglycerides|
1721909|NCT00675766|3170453|Superiority or Other|||||||0.65|||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.04 to 2.51. Range of z-scores at Year 1 follow-up: -2.21 to 2.24.||Repeated Measures ANOVA with visuospatial skills at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing visuospatial and visuoconstructional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.|
1721910|NCT00675766|3170453|Superiority or Other|||||||0.72|||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.00 to 1.68. Range of z-scores at Year 1 follow-up: -2.33 to 1.90.||Repeated Measures ANOVA with memory at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal and nonverbal learning and memory, across time as the within-group factor and HIV serostatus and age group as between-group factors.|
1721911|NCT00675766|3170453|Superiority or Other|||||||0.09|||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.30 to 1.94. Range of z-scores at Year 1 follow-up: -1.83 to 2.11.||Repeated Measures ANOVA with language at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing verbal fluency and naming skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.|
1721912|NCT00675766|3170453|Superiority or Other||||||<|0.07|||||||Repeated Measures ANOVA|Range of z-scores at baseline: -1.76 to 0.95. Range of z-scores at Year 1 follow-up: -1.18 to 0.84.||Repeated Measures ANOVA with executive function at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing working memory, set shifting, mental flexibility and problem solving, across time as the within-group factor and HIV serostatus and age group as between-group factors.|
1721913|NCT00675766|3170453|Superiority or Other||||||<|0.01|||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.30 to 2.44. Range of z-scores at Year 1 follow-up: -1.82 to 2.00.||Repeated Measures ANOVA with attention at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing attentional abilities, across time as the within-group factor and HIV serostatus and age group as between-group factors.|
1721914|NCT00675766|3170453|Superiority or Other||||||<|0.005|||||||Repeated Measures ANOVA|Range of z-scores at baseline: -2.96 to 1.89. Range of z-scores at Year 1 follow-up: -1.89 to 1.77.||Repeated Measures ANOVA with processing speed at baseline and follow-up, computed as z-scored derived composite score of multiple neuropsychological measures assessing speed of cognitive information processing, across time as the within-group factor and HIV serostatus and age group as between-group factors.|
1721915|NCT00675766|3170453|Superiority or Other||||||<|0.001|||||||Repeated Measures ANOVA|Range of z-scores at baseline: -1.69 to 1.38. Range of z-scores at Year 1 follow-up: -1.28 to 1.36.||Repeated Measures ANOVA with overall neurocognitive performance at baseline and follow-up, computed as z-scored derived composite score of 14 individual neuropsychological measures assessing attention, processing speed, visuospatial skills, language, memory, executive function and motor skills, across time as the within-group factor and HIV serostatus and age group as between-group factors.|
1721916|NCT00674986|3170494|Superiority or Other|||||||0.0003|||||||t-test, 2 sided||||
1721917|NCT00674986|3170495|Superiority or Other|||||||0.047|||||||t-test, 2 sided||||
1721918|NCT00674986|3170496|Superiority or Other|||||||0.1146|||||||t-test, 2 sided||||
1721919|NCT00674986|3170497|Superiority or Other|||||||0.116|||||||t-test, 2 sided||||
1721920|NCT00674986|3170498|Superiority or Other|||||||0.2777|||||||t-test, 2 sided||||
1721921|NCT00674986|3170499|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1721922|NCT00674986|3170500|Superiority or Other||Difference|0.28|Standard Error of the Mean|0.14||0.0416|2-Sided|95.0|0.01|0.54|||Fisher Exact||||
1721923|NCT00674973|3170505|Superiority or Other||Hazard Ratio (HR)|0.83||||0.1909|2-Sided|95.0|0.63|1.1|||Log Rank|||Cox proportional hazards model was used to estimate the Hazard Ratio (erlotinib compared with placebo), including 95 percent (%) confidence intervals (CIs).|
1721924|NCT00674817|3170511|Superiority or Other||Mean Difference (Final Values)|-0.024|Standard Error of the Mean|0.0529|||2-Sided|95.0|-0.129|0.08||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)|
1721925|NCT00674817|3170511|Superiority or Other||Mean Difference (Final Values)|-0.077|Standard Error of the Mean|0.052|||2-Sided|95.0|-0.18|0.026||||||GSK961081 1200 mcg Plus SAL GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)|
1721926|NCT00674817|3170511|Superiority or Other||Mean Difference (Final Values)|0.014|Standard Error of the Mean|0.0509|||2-Sided|95.0|-0.087|0.114||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721927|NCT00674817|3170511|Superiority or Other||Mean Difference (Final Values)|-0.108|Standard Error of the Mean|0.0522|||2-Sided|95.0|-0.211|-0.005||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)|
1721928|NCT00674817|3170511|Superiority or Other||Mean Difference (Final Values)|-0.009|Standard Error of the Mean|0.0498|||2-Sided|95.0|-0.108|0.089||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours|
1721929|NCT00674817|3170511|Superiority or Other||Mean Difference (Final Values)|-0.171|Standard Error of the Mean|0.0489|||2-Sided|95.0|-0.267|-0.075||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours|
1721930|NCT00674817|3170511|Superiority or Other||Mean Difference (Final Values)|-0.057|Standard Error of the Mean|0.0481|||2-Sided|95.0|-0.152|0.038||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours|
1721931|NCT00674817|3170511|Superiority or Other||Mean Difference (Final Values)|-0.166|Standard Error of the Mean|0.0493|||2-Sided|95.0|-0.263|-0.069||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours|
1721932|NCT00674817|3170511|Superiority or Other||Mean Difference (Final Values)|-0.028|Standard Error of the Mean|0.0507|||2-Sided|95.0|-0.128|0.072||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721933|NCT00674817|3170511|Superiority or Other||Mean Difference (Final Values)|-0.076|Standard Error of the Mean|0.0498|||2-Sided|95.0|-0.174|0.022||||||SK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721934|NCT00674817|3170511|Superiority or Other||Mean Difference (Final Values)|0.001|Standard Error of the Mean|0.049|||2-Sided|95.0|-0.096|0.097||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721935|NCT00674817|3170511|Superiority or Other||Mean Difference (Final Values)|-0.177|Standard Error of the Mean|0.0503|||2-Sided|95.0|-0.276|-0.078||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721936|NCT00674817|3170512|Superiority or Other||Mean Difference (Final Values)|0.104|Standard Error of the Mean|0.1047|||2-Sided|95.0|-0.103|0.311||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)|
1721937|NCT00674817|3170512|Superiority or Other||Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.1035|||2-Sided|95.0|0.006|0.414||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)|
1721938|NCT00674817|3170512|Superiority or Other||Mean Difference (Final Values)|0.173|Standard Error of the Mean|0.1006|||2-Sided|95.0|-0.025|0.372||||||GSK961081 400 mcg Plus IPR versus maximum GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)|
1721939|NCT00674817|3170512|Superiority or Other||Mean Difference (Final Values)|0.312|Standard Error of the Mean|0.1021|||2-Sided|95.0|0.11|0.513||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)|
1721940|NCT00674817|3170512|Superiority or Other||Mean Difference (Final Values)|0.567|Standard Error of the Mean|0.3151|||2-Sided|95.0|-0.054|1.189||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours|
1721941|NCT00674817|3170512|Superiority or Other||Mean Difference (Final Values)|0.829|Standard Error of the Mean|0.3112|||2-Sided|95.0|0.215|1.443||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours|
1721942|NCT00674817|3170512|Superiority or Other||Mean Difference (Final Values)|-0.053|Standard Error of the Mean|0.3056|||2-Sided|95.0|-0.656|0.55||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours|
1721943|NCT00674817|3170512|Superiority or Other||Mean Difference (Final Values)|0.874|Standard Error of the Mean|0.3099|||2-Sided|95.0|0.262|1.485||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours|
1721944|NCT00674817|3170512|Superiority or Other||Mean Difference (Final Values)|0.309|Standard Error of the Mean|0.2392|||2-Sided|95.0|-0.163|0.78||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721945|NCT00674817|3170512|Superiority or Other||Mean Difference (Final Values)|0.309|Standard Error of the Mean|0.2363|||2-Sided|95.0|-0.157|0.775||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721946|NCT00674817|3170512|Superiority or Other||Mean Difference (Final Values)|0.388|Standard Error of the Mean|0.2318|||2-Sided|95.0|-0.069|0.846||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721947|NCT00674817|3170512|Superiority or Other||Mean Difference (Final Values)|0.53|Standard Error of the Mean|0.2352|||2-Sided|95.0|0.066|0.994||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721948|NCT00674817|3170513|Superiority or Other||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|0.8929|||2-Sided|95.0|-2.122|1.401||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)|
1721949|NCT00674817|3170513|Superiority or Other||Mean Difference (Final Values)|-0.809|Standard Error of the Mean|0.8882|||2-Sided|95.0|-2.561|0.944||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)|
1721950|NCT00674817|3170513|Superiority or Other||Mean Difference (Final Values)|0.876|Standard Error of the Mean|0.8644|||2-Sided|95.0|-0.829|2.582||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)|
1721951|NCT00674817|3170513|Superiority or Other||Mean Difference (Final Values)|-1.18|Standard Error of the Mean|0.881|||2-Sided|95.0|-2.918|0.559||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)|
1721952|NCT00674817|3170513|Superiority or Other||Mean Difference (Final Values)|0.466|Standard Error of the Mean|1.1058|||2-Sided|95.0|-1.715|2.648||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours|
1721953|NCT00674817|3170513|Superiority or Other||Mean Difference (Final Values)|-0.016|Standard Error of the Mean|1.0999|||2-Sided|95.0|-2.185|2.154||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours|
1721954|NCT00674817|3170513|Superiority or Other||Mean Difference (Final Values)|0.54|Standard Error of the Mean|1.0786|||2-Sided|95.0|-1.588|2.668||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours|
1721955|NCT00674817|3170513|Superiority or Other||Mean Difference (Final Values)|-0.376|Standard Error of the Mean|1.0997|||2-Sided|95.0|-2.545|1.794||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours|
1721956|NCT00674817|3170513|Superiority or Other||Mean Difference (Final Values)|-1.067|Standard Error of the Mean|1.2416|||2-Sided|95.0|-3.516|1.382||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721957|NCT00674817|3170513|Superiority or Other||Mean Difference (Final Values)|-1.337|Standard Error of the Mean|1.2341|||2-Sided|95.0|-3.771|1.098||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721958|NCT00674817|3170513|Superiority or Other||Mean Difference (Final Values)|1.705|Standard Error of the Mean|1.2125|||2-Sided|95.0|-0.687|4.097||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721959|NCT00674817|3170513|Superiority or Other||Mean Difference (Final Values)|-0.561|Standard Error of the Mean|1.2351|||2-Sided|95.0|-2.997|1.876||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721960|NCT00674817|3170514|Superiority or Other||Mean Difference (Final Values)|-0.713|Standard Error of the Mean|1.3241|||2-Sided|95.0|-3.325|1.899||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)|
1721961|NCT00674817|3170514|Superiority or Other||Mean Difference (Final Values)|0.106|Standard Error of the Mean|1.3201|||2-Sided|95.0|-2.498|2.71||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours (WMC)|
1721962|NCT00674817|3170514|Superiority or Other||Mean Difference (Final Values)|1.181|Standard Error of the Mean|1.2819|||2-Sided|95.0|-1.348|3.71||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)|
1721963|NCT00674817|3170514|Superiority or Other||Mean Difference (Final Values)|-1.394|Standard Error of the Mean|1.3084|||2-Sided|95.0|-3.976|1.187||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours (WMC)|
1721964|NCT00674817|3170514|Superiority or Other||Mean Difference (Final Values)|-1.232|Standard Error of the Mean|1.78|||2-Sided|95.0|-4.743|2.279||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours|
1721965|NCT00674817|3170514|Superiority or Other||Mean Difference (Final Values)|1.827|Standard Error of the Mean|1.7743|||2-Sided|95.0|-1.673|5.327||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours|
1721966|NCT00674817|3170514|Superiority or Other||Mean Difference (Final Values)|-0.077|Standard Error of the Mean|1.7361|||2-Sided|95.0|-3.502|3.348||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours|
1721967|NCT00674817|3170514|Superiority or Other||Mean Difference (Final Values)|-3.266|Standard Error of the Mean|1.7723|||2-Sided|95.0|-6.762|0.23||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours|
1721968|NCT00674817|3170514|Superiority or Other||Mean Difference (Final Values)|-2.182|Standard Error of the Mean|1.8242|||2-Sided|95.0|-5.781|1.416||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721969|NCT00674817|3170514|Superiority or Other||Mean Difference (Final Values)|0.324|Standard Error of the Mean|1.8174|||2-Sided|95.0|-3.261|3.909||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721970|NCT00674817|3170514|Superiority or Other||Mean Difference (Final Values)|0.599|Standard Error of the Mean|1.7809|||2-Sided|95.0|-2.914|4.113||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721971|NCT00674817|3170514|Superiority or Other||Mean Difference (Final Values)|-1.836|Standard Error of the Mean|1.8168|||2-Sided|95.0|-5.42|1.748||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721972|NCT00674817|3170515|Superiority or Other||Mean Difference (Final Values)|0.934|Standard Error of the Mean|0.846|||2-Sided|95.0|-0.735|2.603||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721973|NCT00674817|3170515|Superiority or Other||Mean Difference (Final Values)|3.98|Standard Error of the Mean|0.8395|||2-Sided|95.0|2.324|5.636||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721974|NCT00674817|3170515|Superiority or Other||Mean Difference (Final Values)|0.646|Standard Error of the Mean|0.8172|||2-Sided|95.0|-0.967|2.258||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721975|NCT00674817|3170515|Superiority or Other||Mean Difference (Final Values)|4.094|Standard Error of the Mean|0.83|||2-Sided|95.0|2.456|5.732||||||GSK961081 400 mcg plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721976|NCT00674817|3170516|Superiority or Other||Mean Difference (Final Values)|1.621|Standard Error of the Mean|1.2593|||2-Sided|95.0|-0.863|4.106||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours|
1721977|NCT00674817|3170516|Superiority or Other||Mean Difference (Final Values)|4.266|Standard Error of the Mean|1.249|||2-Sided|95.0|1.802|6.729||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours|
1721978|NCT00674817|3170516|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Error of the Mean|1.2278|||2-Sided|95.0|-2.142|2.703||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours|
1721979|NCT00674817|3170516|Superiority or Other||Mean Difference (Final Values)|4.121|Standard Error of the Mean|1.2464|||2-Sided|95.0|1.662|6.58||||||GSK961081 400 mcg Plus SAL versus maximal GSK961081 400 mcg plus Placebo during 0-27 hours|
1721980|NCT00674817|3170516|Superiority or Other||Mean Difference (Final Values)|2.255|Standard Error of the Mean|1.4077|||2-Sided|95.0|-0.522|5.031||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721981|NCT00674817|3170516|Superiority or Other||Mean Difference (Final Values)|6.985|Standard Error of the Mean|1.396|||2-Sided|95.0|4.231|9.738||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721982|NCT00674817|3170516|Superiority or Other||Mean Difference (Final Values)|1.255|Standard Error of the Mean|1.3725|||2-Sided|95.0|-1.453|3.962||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721983|NCT00674817|3170516|Superiority or Other||Mean Difference (Final Values)|6.588|Standard Error of the Mean|1.3932|||2-Sided|95.0|3.839|9.336||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721984|NCT00674817|3170517|Superiority or Other||Mean Difference (Final Values)|-1.683|Standard Error of the Mean|1.7199|||2-Sided|95.0|-5.076|1.711||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721985|NCT00674817|3170517|Superiority or Other||Mean Difference (Final Values)|2.956|Standard Error of the Mean|1.7178|||2-Sided|95.0|-0.433|6.345||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721986|NCT00674817|3170517|Superiority or Other||Mean Difference (Final Values)|0.007|Standard Error of the Mean|1.6727|||2-Sided|95.0|-3.294|3.307||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721987|NCT00674817|3170517|Superiority or Other||Mean Difference (Final Values)|5.2|Standard Error of the Mean|1.6941|||2-Sided|95.0|1.857|8.542||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721988|NCT00674817|3170518|Superiority or Other||Mean Difference (Final Values)|-2.083|Standard Error of the Mean|3.0023|||2-Sided|95.0|-8.006|3.84||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-27 hours|
1721989|NCT00674817|3170518|Superiority or Other||Mean Difference (Final Values)|5.975|Standard Error of the Mean|2.9958|||2-Sided|95.0|0.065|11.886||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-27 hours|
1721990|NCT00674817|3170518|Superiority or Other||Mean Difference (Final Values)|4.39|Standard Error of the Mean|2.9434|||2-Sided|95.0|-1.418|10.197||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-27 hours|
1721991|NCT00674817|3170518|Superiority or Other||Mean Difference (Final Values)|11.227|Standard Error of the Mean|2.9782|||2-Sided|95.0|5.352|17.103||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-27 hours|
1721992|NCT00674817|3170518|Superiority or Other||Mean Difference (Final Values)|-0.884|Standard Error of the Mean|2.5244|||2-Sided|95.0|-5.864|4.097||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721993|NCT00674817|3170518|Superiority or Other||Mean Difference (Final Values)|7.854|Standard Error of the Mean|2.5196|||2-Sided|95.0|2.883|12.825||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo during 0-4 hours|
1721994|NCT00674817|3170518|Superiority or Other||Mean Difference (Final Values)|2.686|Standard Error of the Mean|2.4738|||2-Sided|95.0|-2.195|7.567||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721995|NCT00674817|3170518|Superiority or Other||Mean Difference (Final Values)|10.198|Standard Error of the Mean|2.5039|||2-Sided|95.0|5.258|15.139||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo during 0-4 hours|
1721996|NCT00674817|3170519|Superiority or Other||Mean Difference (Final Values)|-1.949|Standard Error of the Mean|1.7112|||2-Sided|95.0|-5.325|1.427||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours|
1721997|NCT00674817|3170519|Superiority or Other||Mean Difference (Final Values)|-0.65|Standard Error of the Mean|1.705|||2-Sided|95.0|-4.013|2.714||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours|
1721998|NCT00674817|3170519|Superiority or Other||Mean Difference (Final Values)|0.418|Standard Error of the Mean|1.6565|||2-Sided|95.0|-2.85|3.687||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours|
1721999|NCT00674817|3170519|Superiority or Other||Mean Difference (Final Values)|1.249|Standard Error of the Mean|1.6816|||2-Sided|95.0|-2.069|4.566||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours|
1722000|NCT00674817|3170520|Superiority or Other||Mean Difference (Final Values)|-1.152|Standard Error of the Mean|2.731|||2-Sided|95.0|-6.539|4.236||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-27 hours|
1722001|NCT00674817|3170520|Superiority or Other||Mean Difference (Final Values)|0.93|Standard Error of the Mean|2.717|||2-Sided|95.0|-4.429|6.29||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-27 hours|
1722002|NCT00674817|3170520|Superiority or Other||Mean Difference (Final Values)|2.266|Standard Error of the Mean|2.6691|||2-Sided|95.0|-2.999|7.532||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-27 hours|
1722003|NCT00674817|3170520|Superiority or Other||Mean Difference (Final Values)|4.558|Standard Error of the Mean|2.7064|||2-Sided|95.0|-0.781|9.897||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-27 hours|
1722004|NCT00674817|3170521|Superiority or Other||Mean Difference (Final Values)|-1.231|Standard Error of the Mean|2.197|||2-Sided|95.0|-5.565|3.103||||||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo over 0-4 hours|
1722005|NCT00674817|3170521|Superiority or Other||Mean Difference (Final Values)|1.755|Standard Error of the Mean|2.1869|||2-Sided|95.0|-2.559|6.069||||||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo over 0-4 hours|
1722006|NCT00674817|3170521|Superiority or Other||Mean Difference (Final Values)|1.712|Standard Error of the Mean|2.1453|||2-Sided|95.0|-2.521|5.944||||||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo over 0-4 hours|
1722007|NCT00674817|3170521|Superiority or Other||Mean Difference (Final Values)|3.747|Standard Error of the Mean|2.1768|||2-Sided|95.0|-0.547|8.041||||||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo over 0-4 hours|
1722008|NCT00674817|3170527|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.0534|=|0|2-Sided|90.0|0.012|0.189|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour|
1722009|NCT00674817|3170527|Superiority or Other||Mean Difference (Final Values)|0.136|Standard Error of the Mean|0.05|=|0|2-Sided|90.0|0.053|0.218|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour|
1722010|NCT00674817|3170527|Superiority or Other||Mean Difference (Final Values)|-0.022|Standard Error of the Mean|0.0625|=|0|2-Sided|90.0|-0.125|0.081|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour|
1722011|NCT00674817|3170527|Superiority or Other||Mean Difference (Final Values)|0.092|Standard Error of the Mean|0.053|=|0|2-Sided|90.0|0.004|0.179|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour|
1722012|NCT00674817|3170527|Superiority or Other||Mean Difference (Final Values)|0.094|Standard Error of the Mean|0.05|=|0|2-Sided|90.0|0.011|0.177|||Mix model|||GSK961081 1200 mcg Plus SAL versus that due to GSK961081 1200 mcg plus Placebo at 12 hour|
1722013|NCT00674817|3170527|Superiority or Other||Mean Difference (Final Values)|0.052|Standard Error of the Mean|0.0621|=|0|2-Sided|90.0|-0.05|0.155|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour|
1722014|NCT00674817|3170527|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.0516|=|0.027|2-Sided|90.0|0.015|0.185|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour|
1722015|NCT00674817|3170527|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.0493|=|0|2-Sided|90.0|0.039|0.201|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour|
1722016|NCT00674817|3170527|Superiority or Other||Mean Difference (Final Values)|-0.067|Standard Error of the Mean|0.0612|=|0|2-Sided|90.0|-0.168|0.034|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour|
1722017|NCT00674817|3170527|Superiority or Other||Mean Difference (Final Values)|0.068|Standard Error of the Mean|0.0523|=|0|2-Sided|90.0|-0.019|0.154|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour|
1722018|NCT00674817|3170527|Superiority or Other||Mean Difference (Final Values)|0.092|Standard Error of the Mean|0.0496|=|0|2-Sided|90.0|0.01|0.174|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour|
1722019|NCT00674817|3170527|Superiority or Other||Mean Difference (Final Values)|-0.066|Standard Error of the Mean|0.0616|=|0|2-Sided|90.0|-0.168|0.036|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 1 hour|
1722020|NCT00674817|3170528|Superiority or Other||Mean Difference (Final Values)|0.122|Standard Error of the Mean|0.0222|<|0.001|2-Sided|90.0|0.086|0.159|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 24 hour|
1722021|NCT00674817|3170528|Superiority or Other||Mean Difference (Final Values)|0.055|Standard Error of the Mean|0.023|=|0|2-Sided|90.0|0.017|0.093|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 12 hour|
1722022|NCT00674817|3170528|Superiority or Other||Mean Difference (Final Values)|0.017|Standard Error of the Mean|0.019|=|0.188|2-Sided|90.0|-0.015|0.048|||Mix model|||GSK961081 1200 mcg Plus IPR versus GSK961081 1200 mcg plus Placebo at 1 hour|
1722023|NCT00674817|3170528|Superiority or Other||Mean Difference (Final Values)|0.126|Standard Error of the Mean|0.022|<|0.001|2-Sided|90.0|0.09|0.162|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 24 hour|
1722024|NCT00674817|3170528|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.0229|<|0.001|2-Sided|90.0|0.053|0.129|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 12 hour|
1722025|NCT00674817|3170528|Superiority or Other||Mean Difference (Final Values)|0.019|Standard Error of the Mean|0.0188|<|0.155|2-Sided|90.0|-0.012|0.05|||Mix model|||GSK961081 1200 mcg Plus SAL versus GSK961081 1200 mcg plus Placebo at 1 hour|
1722026|NCT00674817|3170528|Superiority or Other||Median Difference (Final Values)|0.141|Standard Error of the Mean|0.0214|<|0.001|2-Sided|90.0|0.105|0.176|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 24 hour|
1722027|NCT00674817|3170528|Superiority or Other||Mean Difference (Final Values)|0.124|Standard Error of the Mean|0.0225|<|0.001|2-Sided|90.0|0.087|0.161|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 12 hour|
1722028|NCT00674817|3170528|Superiority or Other||Mean Difference (Final Values)|0.014|Standard Error of the Mean|0.0185|=|0|2-Sided|90.0|-0.016|0.045|||Mix model|||GSK961081 400 mcg Plus IPR versus GSK961081 400 mcg plus Placebo at 1 hour|
1722029|NCT00674817|3170528|Superiority or Other||Median Difference (Final Values)|0.123|Standard Error of the Mean|0.0217|<|0.001|2-Sided|90.0|0.087|0.158|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 24 hour|
1722030|NCT00674817|3170528|Superiority or Other||Mean Difference (Final Values)|0.139|Standard Error of the Mean|0.0227|<|0.001|2-Sided|90.0|0.101|0.176|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo at 12 hour|
1722031|NCT00674817|3170528|Superiority or Other||Mean Difference (Final Values)|0.039|Standard Error of the Mean|0.0187|=|0|2-Sided|90.0|0.008|0.069|||Mix model|||GSK961081 400 mcg Plus SAL versus GSK961081 400 mcg plus Placebo' at 1 hour|
1722032|NCT00674765|3170529|Superiority or Other|||||||0.388|||||||t-test, 2 sided|t=.87|||
1722033|NCT00674700|3170533|Superiority or Other|||||||0.0095|||||||ANCOVA||||
1722034|NCT00674700|3170533|Superiority or Other|||||||0.0086|||||||ANCOVA||||
1722035|NCT00674700|3170534|Superiority or Other|||||||0.015||||||main effects= treatment and pools of study centers, Covariates = age, gender, asthma status, sensitization status and baseline ARTSS|ANCOVA||||
1722036|NCT00674700|3170534|Superiority or Other|||||||0.0066||||||main effects = treatment and pools of study centers, Covariates = age, gender, asthma status, sensitization status and baseline ARTSS|ANCOVA||||
1722037|NCT00674609|3170541|Superiority or Other||Estimated mean treatment difference|0.01||||0.899|2-Sided|95.0|-0.19|0.22|||Regression, Logistic|||The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.|
1722038|NCT00674609|3170541|Superiority or Other||estimated mean treatment difference|-0.04||||0.688|2-Sided|95.0|-0.25|0.16|||Regression, Logistic|||The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.|
1722039|NCT00674609|3170542|Superiority or Other||Estimated mean treatment difference|-4.07||||0.048|2-Sided|95.0|-8.1|-0.05|||ANCOVA|||Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.|
1722040|NCT00674609|3170542|Superiority or Other||Estimated mean treatment difference|-1.04||||0.619|2-Sided|95.0|-5.23|3.15|||ANCOVA|||Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.|
1722041|NCT00674609|3170543|Superiority or Other||estimated mean treatment difference|0.84||||0.793|2-Sided|95.0|-5.46|7.13|||ANCOVA|||Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.|
1722042|NCT00674609|3170543|Superiority or Other||estimated mean treatment difference|2.47||||0.443|2-Sided|95.0|-3.87|8.81|||ANCOVA|||Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.|
1722043|NCT00674609|3170544|Superiority or Other||Estimated treatment difference|0.64||||0.028|2-Sided|95.0|0.07|1.22|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.|
1722044|NCT00674609|3170544|Superiority or Other||Estimated mean treatment difference|0.68||||0.021|2-Sided|95.0|0.1|1.25|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.|
1722045|NCT00674609|3170545|Superiority or Other||Estimated mean treatment difference|0.66||||0.056|2-Sided|95.0|-0.02|1.33|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.|
1722071|NCT00673660|3170655|Superiority or Other|||||||0.972||||||p-Values less than 0.05 were considered statistically significant.|t-test, 1 sided|||HDL cholesterol|
1722072|NCT00673660|3170655|Superiority or Other||||||<|0.001||||||p-Values less than 0.05 were considered statistically significant.|t-test, 2 sided|||LDL cholesterol|
1722046|NCT00674609|3170545|Superiority or Other||estimated mean treatment difference|0.83||||0.016|2-Sided|95.0|0.16|1.51|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.|
1722047|NCT00674609|3170546|Superiority or Other||Estimated mean treatment difference|0.62||||0.053|2-Sided|95.0|-0.01|1.25|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.|
1722048|NCT00674609|3170546|Superiority or Other||Estimated mean treatment difference|0.65||||0.045|2-Sided|95.0|0.01|1.28|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.|
1722049|NCT00674609|3170547|Superiority or Other||Estimated mean treatment difference|0.46||||0.126|2-Sided|95.0|-0.13|1.05|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.|
1722050|NCT00674609|3170547|Superiority or Other||Estimated mean treatment difference|0.49||||0.11|2-Sided|95.0|-0.11|1.09|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.|
1722051|NCT00674609|3170548|Superiority or Other||Estimated mean treatment difference|0.02||||0.95|2-Sided|95.0|-0.64|0.68|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.|
1722052|NCT00674609|3170548|Superiority or Other||Estimated mean treatment difference|-0.31||||0.346|2-Sided|95.0|-0.97|0.34|||ANCOVA|||Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.|
1722053|NCT00674609|3170549|Superiority or Other||Estimated mean treatment difference|-0.32||||0.244|2-Sided|95.0|-0.86|0.22|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.|
1722054|NCT00674609|3170549|Superiority or Other||estimated mean treatment difference|-0.67||||0.014|2-Sided|95.0|-1.21|-0.14|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.|
1722055|NCT00674583|3170559|Non-Inferiority|Criterion for non-inferiority evaluation: The lower limit (LL) of the two-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Menjugate Group) in the percentages of subjects with vaccine response to rSBA-MenC is greater than or equal to (≥) the pre-defined clinical limit of –10%.|Difference in percentage|-0.88|||||2-Sided|95.0|-5.25|5.75||||||To demonstrate the non-inferiority of the Nimenrix group compared to the Menjugate group, two-sided standardized asymptotic 95% confidence interval (CI) for the groups difference [Nimenrix group minus Menjugate group] in the percentages of subjects with bactericidal vaccine response to MenC was computed.|
1722056|NCT00674570|3170560|Other||Mean Difference (Net)|0.16|Standard Error of the Mean|0.06|=|0|2-Sided|95.0|0.04|0.28|||Mixed Models Analysis|||Extinction retention|
1722057|NCT00674570|3170560|Other||Mean Difference (Net)|0.18|Standard Error of the Mean|0.06|=|0|2-Sided|95.0|0.05|0.3|||Mixed Models Analysis|||Extinction Retention (first 2 trials) First trials were selected as a test of extinction retention, since repeated presentations of the CS without a UCS were expected to result in additional fear extinction.|
1722058|NCT00674570|3170560|Superiority||Mean Difference (Net)|0.12|Standard Error of the Mean|0.05|=|0.02|2-Sided|95.0|0.02|0.22|||Mixed Models Analysis|||Extinction End (last trial)|
1722059|NCT00674570|3170560|Superiority||Mean Difference (Net)|0.16|Standard Error of the Mean|0.05|=|0|2-Sided|95.0|0.06|0.26|||Mixed Models Analysis|||Extinction End (last trial)|
1722060|NCT00674570|3170560|Superiority||Mean Difference (Net)|0.05|Standard Error of the Mean|0.05|=|0|2-Sided|95.0|-0.05|0.15|||Mixed Models Analysis|||Fear Extinction Beginning (first trial)|
1722061|NCT00674570|3170560|Superiority||Mean Difference (Net)|0.09|Standard Error of the Mean|0.05|=|0|2-Sided|95.0|-0.01|0.2|||Mixed Models Analysis|||Fear Extinction Beginning (first trial)|
1722062|NCT00674570|3170560|Superiority||Median Difference (Net)|0.04|Standard Error of the Mean|0.06|=|0|2-Sided|95.0|-0.07|0.17|||Mixed Models Analysis|||Fear Conditioning End (last trial)|
1722063|NCT00674570|3170560|Superiority||Median Difference (Net)|0.05|Standard Error of the Mean|0.06|=|0|2-Sided|95.0|-0.07|0.18|||Mixed Models Analysis|||Fear Conditioning End (last trial)|
1722064|NCT00674570|3170560|Superiority||Mean Difference (Net)|-0.05|Standard Error of the Mean|0.06|=|0|2-Sided|95.0|-0.17|0.07|||Mixed Models Analysis|||Fear Conditioning Beginning (first trial)|
1722065|NCT00674570|3170560|Superiority||Mean Difference (Net)|-0.02|Standard Error of the Mean|0.06|=|0|2-Sided|95.0|-0.15|0.1|||Mixed Models Analysis|||Fear Conditioning Beginning (first trial)|
1722066|NCT00673881|3170625|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1722067|NCT00673881|3170633|Superiority or Other||||||NS|0|||||||t-test, 2 sided|||Comparison from baseline to end-of-treatment|
1722068|NCT00673881|3170634|Superiority or Other|||||||0.0002|||||||t-test, 2 sided|||Comparison baseline to end-of-treatment|
1722069|NCT00673881|3170635|Superiority or Other|||||||0.0042|||||||t-test, 2 sided||||
1722079|NCT00673465|3170672|Superiority or Other||Difference in least squares mean|-4.4|||<|0.5269|2-Sided|95.0|-18.5|9.7|||ANOVA|ANOVA model extracting the effect due to treatment, period, sequence and participant.|||
1722080|NCT00673452|3170673|Superiority or Other||Least Squares Mean Difference|-0.83|||<|0.001|2-Sided|95.0|-1.21|-0.45||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722081|NCT00673452|3170674|Superiority or Other|||||||1||||||P-value for Suicidal Ideation. A priori threshold for statistical significance is 0.05.|Fisher Exact||||
1722082|NCT00673452|3170675|Superiority or Other||Least Squares Mean Difference|1.96||||0.003|2-Sided|95.0|0.67|3.26||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722083|NCT00673452|3170676|Superiority or Other||Least Squares Mean Difference|0.52||||0.434|2-Sided|95.0|-0.79|1.84||P-value for Diastolic Blood Pressure (DBP). A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722084|NCT00673452|3170676|Superiority or Other||Least Squares Mean Difference|1.82||||0.084|2-Sided|95.0|-0.25|3.88||P-value for Systolic Blood Pressure (SBP). A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Change = baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722085|NCT00673452|3170677|Superiority or Other|||||||0.003||||||A priori threshold for statistical significance is 0.05.|Fisher Exact||||
1722086|NCT00673452|3170678|Superiority or Other|||||||0.002||||||A priori threshold for statistical significance is 0.05.|Fisher Exact||||
1722087|NCT00673452|3170679|Superiority or Other||Least Squares Mean Difference|-0.87|||<|0.001|2-Sided|95.0|-1.32|-0.43||P-value for Stiffness. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722088|NCT00673452|3170679|Superiority or Other||Least Squares Mean Difference|-0.49|||<|0.05|2-Sided|95.0|-0.97|0.0||P-value for Sleep. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722089|NCT00673452|3170679|Superiority or Other||Least Squares Mean Difference|-0.72|||<|0.003|2-Sided|95.0|-1.19|-0.25||P-value for Pain. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722090|NCT00673452|3170679|Superiority or Other||Least Squares Mean Difference|-0.64|||<|0.003|2-Sided|95.0|-1.05|-0.22||P-value for Anxiety. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722091|NCT00673452|3170679|Superiority or Other||Least Squares Mean Difference|-0.75|||<|0.001|2-Sided|95.0|-1.18|-0.32||P-value for Mood. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: Likert scale change from baseline at endpoint = Likert scale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722092|NCT00673452|3170680|Superiority or Other||Least Squares Mean Difference|-0.96||||0.083|2-Sided|95.0|-2.05|0.13||A priori threshold for statistical significance is 0.05.|ANCOVA|Model: MGH-CPFQ change from baseline at endpoint = MGH-CPFQ baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722093|NCT00673452|3170681|Superiority or Other||Least Squares Mean Difference|3.83|||<|0.001|2-Sided|95.0|2.05|5.6||P-value for Mental Component Summary (MCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722094|NCT00673452|3170681|Superiority or Other||Least Squares Mean Difference|1.14|||<|0.134|2-Sided|95.0|-0.35|2.64||P-value for Physical Component Summary (PCS). The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722095|NCT00673452|3170681|Superiority or Other||Least Squares Mean Difference|4.31|||<|0.015|2-Sided|95.0|0.84|7.79||P-value for Vitality. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722096|NCT00673452|3170681|Superiority or Other||Least Squares Mean Difference|6.67|||<|0.001|2-Sided|95.0|2.73|10.61||P-value for Social Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722097|NCT00673452|3170681|Superiority or Other||Least Squares Mean Difference|1.59|||<|0.632|2-Sided|95.0|-4.93|8.11||P-value for Role-Physical. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722098|NCT00673452|3170681|Superiority or Other||Least Squares Mean Difference|9.78|||<|0.004|2-Sided|95.0|3.11|16.45||P-value for Role-Emotional. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722318|NCT00667810|3171323|Superiority or Other|||||||0.277|||||||Cochran-Mantel-Haenszel||||
1722319|NCT00667810|3171325|Superiority or Other|||||||0.714|||||||Log Rank||||
1722099|NCT00673452|3170681|Superiority or Other||Least Squares Mean Difference|5.47|||<|0.002|2-Sided|95.0|2.06|8.88||P-value for Physical Functioning. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722100|NCT00673452|3170681|Superiority or Other||Least Squares Mean Difference|7.44|||<|0.001|2-Sided|95.0|4.41|10.47||P-value for Mental Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722101|NCT00673452|3170681|Superiority or Other||Least Squares Mean Difference|6.42|||<|0.001|2-Sided|95.0|3.41|9.43||P-value for General Health. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722102|NCT00673452|3170681|Superiority or Other||Least Squares Mean Difference|5.22|||<|0.003|2-Sided|95.0|1.76|8.67||P-value for Bodily Pain. The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: SF-36 subscale change from baseline at endpoint = SF-36 subscale at baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722103|NCT00673452|3170682|Superiority or Other||Least Squares Mean Difference|0.07||||0.907|2-Sided|95.0|-1.13|1.27||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BAI total score change from baseline to endpoint = baseline BAI total + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722104|NCT00673452|3170683|Superiority or Other||Least Squares Mean Difference|-0.34|||<|0.001|2-Sided|95.0|-0.51|-0.16||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: CGI-S score change from baseline at endpoint = CGI-S score baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722105|NCT00673452|3170684|Superiority or Other||Least Squares Mean Difference|-1.89||||0.007|2-Sided|95.0|-3.25|-0.53||The p-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BDI-II Total score change from baseline to endpoint = baseline BDI-II total score + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722106|NCT00673452|3170685|Superiority or Other||Least Squares Mean Difference|-0.94|||<|0.001|2-Sided|95.0|-1.49|-0.38||P-value for Reduced Motivation. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722107|NCT00673452|3170685|Superiority or Other||Least Squares Mean Difference|-0.88|||<|0.005|2-Sided|95.0|-1.49|-0.26||P-value for Reduced Activity. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722108|NCT00673452|3170685|Superiority or Other||Least Squares Mean Difference|-0.92|||<|0.003|2-Sided|95.0|-1.52|-0.32||P-value for Mental Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722109|NCT00673452|3170685|Superiority or Other||Least Squares Mean Difference|-0.72|||<|0.013|2-Sided|95.0|-1.3|-0.15||P-value for Physical Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722110|NCT00673452|3170685|Superiority or Other||Least Squares Mean Difference|-0.83|||<|0.005|2-Sided|95.0|-1.41|-0.25||P-value for General Fatigue. P-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|ANCOVA|Model: MFI subscale change from baseline at endpoint = MFI subscale baseline + treatment + pooled investigator.|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722111|NCT00673452|3170686|Superiority or Other||Least Squares Mean Difference|-0.93|||<|0.001|2-Sided|95.0|-1.33|-0.52||P-value for Average Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722112|NCT00673452|3170686|Superiority or Other||Least Squares Mean Difference|-1.39|||<|0.001|2-Sided|95.0|-1.92|-0.86||P-value for Enjoyment of Life Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722113|NCT00673452|3170686|Superiority or Other||Least Squares Mean Difference|-0.87|||<|0.001|2-Sided|95.0|-1.35|-0.39||P-value for Sleep Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722114|NCT00673452|3170686|Superiority or Other||Least Squares Mean Difference|-0.95|||<|0.001|2-Sided|95.0|-1.38|-0.52||P-value for Relations with Other People Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722115|NCT00673452|3170686|Superiority or Other||Least Squares Mean Difference|-0.76|||<|0.001|2-Sided|95.0|-1.21|-0.32||P-value for Normal Work Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722116|NCT00673452|3170686|Superiority or Other||Least Squares Mean Difference|-0.8|||<|0.001|2-Sided|95.0|-1.24|-0.36||P-value for Walking Ability Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722117|NCT00673452|3170686|Superiority or Other||Least Squares Mean Difference|-0.95|||<|0.001|2-Sided|95.0|-1.41|-0.49||P-value for Mood Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722118|NCT00673452|3170686|Superiority or Other||Least Squares Mean Difference|-0.94|||<|0.001|2-Sided|95.0|-1.39|-0.49||P-value for General Activity Interference. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722119|NCT00673452|3170686|Superiority or Other||Least Squares Mean Difference|-0.76|||<|0.001|2-Sided|95.0|-1.2|-0.31||P-value for Pain Right Now Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722120|NCT00673452|3170686|Superiority or Other||Least Squares Mean Difference|-0.74|||<|0.001|2-Sided|95.0|-1.13|-0.35||P-value for Average Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722121|NCT00673452|3170686|Superiority or Other||Least Squares Mean Difference|-0.61|||<|0.001|2-Sided|95.0|-0.99|-0.24||P-value for Least Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722122|NCT00673452|3170686|Superiority or Other||Least Squares Mean Difference|-0.75|||<|0.001|2-Sided|95.0|-1.19|-0.31||P-value for Worst Pain Severity. P-value is not adjusted for multiple comparisons. A priori threshold for statistical significance is 0.05.|ANCOVA|Model: BPI Score change from baseline to LOCF endpoint = BPI baseline + treatment + pooled investigator|Least Squares Mean Difference = Duloxetine minus Placebo.||
1722123|NCT00673452|3170687|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Model: PGI-S = baseline PGI-S + treatment + pooled investigator + visit + treatment-by-visit + baseline-by-visit.||Patients treated with 60-120 mg duloxetine for 12 weeks compared with placebo will show greater improvement in symptoms as assessed by Patient's Global Impressions of Improvement (PGI-I). Sample size determined using 2-sided t-test with significance level of 0.05, and discontinuation rate of 5% without postbaseline data. With 261 patients per arm, study has approximately 85% power to detect treatment group difference of –0.4 points (standard deviation of 1.5) in PGI-I between treatment groups.|
1722124|NCT00673400|3170690|Superiority or Other|||||||0.01||||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Mental component summary (MCS)|
1722125|NCT00673400|3170690|Superiority or Other|||||||0.65||||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Physical component summary (PCS)|
1722126|NCT00673400|3170691|Superiority or Other||||||<|1e-07|||||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method|||
1722127|NCT00673400|3170691|Superiority or Other||||||<|1e-07|||||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method|||
1722128|NCT00673400|3170691|Superiority or Other||||||<|1e-07|||||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method|||
1722129|NCT00673400|3170692|Superiority or Other||||||<|1e-07|||||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method|||
1722130|NCT00673400|3170692|Superiority or Other||||||<|1e-07|||||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method|||
1722131|NCT00673400|3170692|Superiority or Other||||||<|1e-07|||||||Wilcoxon (Mann-Whitney)|two-sided, paired test, exact method|||
1722132|NCT00673400|3170695|Superiority or Other|||||||0.0074||||||based on 30 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Embarrassment (E)|
1722133|NCT00673400|3170695|Superiority or Other|||||||0.0012||||||based on 30 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Depression/self-perception (D/S)|
1722134|NCT00673400|3170695|Superiority or Other|||||||0.088||||||based on 29 matched pairs|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Coping/behavior (C/B)|
1722135|NCT00673400|3170695|Superiority or Other|||||||0.134||||||based on 28 pairwise matches|Wilcoxon (Mann-Whitney)|matched pair test, two-sided, exact method||Lifestyle (LS)|
1722136|NCT00673387|3170712|Superiority or Other|||||||0.0034|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722137|NCT00673387|3170712|Superiority or Other|||||||0.0073|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722138|NCT00673387|3170712|Superiority or Other|||||||0.0122|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722139|NCT00673387|3170712|Superiority or Other|||||||0.0128|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722140|NCT00673387|3170712|Superiority or Other|||||||0.0222|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722320|NCT00667810|3171325|Superiority or Other|||||||0.933|||||||Log Rank||||
1722141|NCT00673387|3170713|Superiority or Other|||||||0.0014|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722142|NCT00673387|3170713|Superiority or Other|||||||0.0257|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722143|NCT00673387|3170713|Superiority or Other|||||||0.0046|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722144|NCT00673387|3170713|Superiority or Other|||||||0.0047|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722145|NCT00673387|3170713|Superiority or Other|||||||0.0049|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722146|NCT00673387|3170714|Superiority or Other|||||||0.0327|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722147|NCT00673387|3170714|Superiority or Other|||||||0.3717|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722148|NCT00673387|3170714|Superiority or Other|||||||0.069|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722149|NCT00673387|3170714|Superiority or Other|||||||0.0647|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722150|NCT00673387|3170714|Superiority or Other|||||||0.0464|||||||t-test, 2 sided|||Based on a general linear model general linear model that includes baseline value and factors for treatment group, sex, baseline BMI category (<35 kg/m2, 35 to <40 kg/m2, ≥40 kg/m2).|
1722151|NCT00673387|3170718|Superiority or Other|||||||0.0082|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.|
1722152|NCT00673387|3170718|Superiority or Other|||||||0.0409|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.|
1722153|NCT00673387|3170718|Superiority or Other|||||||0.1357|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.|
1722154|NCT00673387|3170718|Superiority or Other|||||||0.0265|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate.|
1722155|NCT00673387|3170718|Superiority or Other|||||||0.0404|||||||t-test, 2 sided|||Change at Week 28 based on a general linear model with factors for treatment group, sex, baseline BMI category, and baseline value as a covariate|
1722156|NCT00673387|3170722|Superiority or Other|||||||0.372||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.|
1722157|NCT00673387|3170722|Superiority or Other|||||||0.3667||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.|
1722158|NCT00673387|3170722|Superiority or Other|||||||0.6633||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%|
1722159|NCT00673387|3170722|Superiority or Other|||||||0.5375||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%|
1722160|NCT00673387|3170722|Superiority or Other|||||||0.4207||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.|
1722321|NCT00667810|3171326|Superiority or Other|||||||0.797|||||||Log Rank||||
1722161|NCT00673387|3170722|Superiority or Other|||||||0.2232||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.|
1722162|NCT00673387|3170722|Superiority or Other|||||||0.2122||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.|
1722163|NCT00673387|3170722|Superiority or Other|||||||0.4503||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.|
1722164|NCT00673387|3170722|Superiority or Other|||||||0.3433||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.|
1722165|NCT00673387|3170722|Superiority or Other|||||||0.251||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.|
1722166|NCT00673387|3170722|Superiority or Other|||||||0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided||||
1722167|NCT00673387|3170722|Superiority or Other||||||<|0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided||||
1722168|NCT00673387|3170722|Superiority or Other||||||<|0.0004||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.|
1722169|NCT00673387|3170722|Superiority or Other||||||<|0.0002||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.|
1722170|NCT00673387|3170722|Superiority or Other||||||<|0.0001||||||unadjusted for multiple comparisons; significance level of 0.0492 based on the Haybittle-Peto Criterion.|t-test, 2 sided|||When multiplicity not considered, sample size of 50 participants per arm (after dropouts) was considered adequate to detect a difference of 4.5% in mean body weight change from baseline to Week 28 between one effective pramlintide + metreleptin combination treatment group versus the placebo, Pramlintide 360 mcg BID + Placebo-M, or Metreleptin 5.0 mg BID + Placebo-P treatment arms with approximately 90% power, assuming a common within-treatment standard deviation of 6.858%.|
1722171|NCT00673231|3170737|Superiority or Other||Mean Difference (Final Values)|-25.0|Standard Error of the Mean|4.718|<|0.0001|2-Sided|95.0|-34.3|-15.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1722172|NCT00673231|3170737|Superiority or Other||Mean Difference (Final Values)|-22.1|Standard Error of the Mean|4.616|<||2-Sided|95.0|-31.2|-13.1||||||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1722173|NCT00673231|3170737|Superiority or Other||Mean Difference (Final Values)|-15.8|Standard Error of the Mean|4.684|<|0.0008|2-Sided|95.0|-25.0|-6.6||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1722217|NCT00672737|3170817|Superiority or Other||Slope|-0.9694||||0.05|2-Sided|95.0|-1.9127|-0.0261|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for SaO2: for every 1-%-absolute decrease in the nadir SaO2 the cold pain threshold will additionally increase by 0.9694 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.|
1722174|NCT00673231|3170738|Superiority or Other||Risk Difference (RD)|8.7|Standard Error of the Mean|3.634||0.0166|2-Sided|95.0|1.6|15.8||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0|
1722175|NCT00673231|3170738|Superiority or Other||Risk Difference (RD)|5.8|Standard Error of the Mean|3.434||0.0903|2-Sided|95.0|-0.9|12.5||not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0|
1722176|NCT00673231|3170738|Superiority or Other||Risk Difference (RD)|7.2|Standard Error of the Mean|3.536||0.0427|2-Sided|95.0|0.2|14.1||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|Regression, Logistic|Methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, adjustment for stratum (other oral anti-diab med use) and baseline value.||H0: proportion(treat) minus proportion(placebo) = 0 versus the alternative HA: proportion(treat) minus proportion(placebo) =/= 0|
1722177|NCT00673231|3170739|Superiority or Other||Mean Difference (Final Values)|-6.23|Standard Error of the Mean|1.3286|<|0.0001|2-Sided|95.0|-8.84|-3.63||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1722178|NCT00673231|3170739|Superiority or Other||Mean Difference (Final Values)|-5.69|Standard Error of the Mean|1.3045|<|0.0001|2-Sided|95.0|-8.25|-3.13||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1722179|NCT00673231|3170739|Superiority or Other||Mean Difference (Final Values)|-6.87|Standard Error of the Mean|1.3195|<|0.0001|2-Sided|95.0|-9.46|-4.28||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1722180|NCT00673231|3170740|Superiority or Other||Mean Difference (Final Values)|-1.68|Standard Error of the Mean|0.2578|<|0.0001|2-Sided|95.0|-2.19|-1.18||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1722181|NCT00673231|3170740|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.2523|<|0.0001|2-Sided|95.0|-1.5|-0.5||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1722182|NCT00673231|3170740|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.256|<|0.0001|2-Sided|95.0|-1.5|-0.49||significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0|
1722183|NCT00673231|3170741|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.0733|<|0.0001|2-Sided|95.0|-0.74|-0.45||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)|
1722184|NCT00673231|3170741|Superiority or Other||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.0718|<|0.0001|2-Sided|95.0|-0.66|-0.38||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)|
1722185|NCT00673231|3170741|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.0726|<|0.0001|2-Sided|95.0|-0.59|-0.31||significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.|ANCOVA|with treatment group (all treatment groups included) and stratum (other oral anti-diabetic med use) as effect and baseline value as covariate.||The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)|
1722186|NCT00673049|3170770|Superiority or Other||Difference in response rates|1.668||||0.338|2-Sided|95.0|-1.7|5.1|||Chi-squared||||
1722258|NCT00670488|3171023|Other||Cmax GMR|1.95||||||||||||||The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.|
1722187|NCT00673049|3170771|Superiority or Other||Hazard Ratio (HR)|1.075||||0.426|2-Sided|95.0|0.898|1.287||One-sided significance level at alpha=0.001 was used. Two-sided p-value was reported.|Log Rank|||P-value was calculated using log-rank test stratified by gender (Male or Female), ECOG performance status (less than or equal to [=<1] or 2), and region (United States/Canada, European Union, rest of world). The stratified Cox proportional hazards model was fitted to estimate the hazard ratio, using the same stratification variables as above.|
1722188|NCT00673049|3170772|Superiority or Other||Hazard Ratio (HR)|1.091||||0.35|2-Sided|95.0|0.909|1.31||One-sided significance level at alpha=0.024 was used. Two-sided p-value was reported.|Log Rank|Nominal p-values were reported without adjustment for the interim analysis.||P-value was calculated using log-rank test stratified by gender (Male or Female), Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to [=<1] or 2), and region (United States/Canada, European Union, rest of world). The stratified Cox proportional hazards model was fitted to estimate the hazard ratio, using the same stratification variables as above.|
1722189|NCT00672984|3170779|Superiority or Other||Mean Difference (Final Values)|3.63||||||90.0|-0.41|7.66|||||||
1722190|NCT00672984|3170779|Superiority or Other||Mean Difference (Final Values)|49.85||||||90.0|44.71|54.98|||||||
1722191|NCT00672984|3170780|Superiority or Other||Mean Difference (Final Values)|0.93||||||90.0|-2.77|4.63|||||||
1722192|NCT00672984|3170780|Superiority or Other||Mean Difference (Final Values)|15.32||||||90.0|11.75|18.89|||||||
1722193|NCT00672984|3170781|Superiority or Other||Mean Difference (Final Values)|3.44||||||90.0|1.77|5.11|||||||
1722194|NCT00672984|3170781|Superiority or Other||Mean Difference (Final Values)|-19.85||||||90.0|-21.92|-17.78|||||||
1722195|NCT00672984|3170782|Superiority or Other||Mean Difference (Final Values)|4.73||||||90.0|3.08|6.38|||||||
1722196|NCT00672984|3170782|Superiority or Other||Mean Difference (Final Values)|-6.76||||||90.0|-8.01|-5.51|||||||
1722197|NCT00672984|3170783|Superiority or Other||Mean Difference (Final Values)|10.8||||||90.0|7.63|13.97|||||||
1722198|NCT00672984|3170783|Superiority or Other||Mean Difference (Final Values)|1.64||||||90.0|-0.99|4.27|||||||
1722199|NCT00672984|3170784|Superiority or Other||Mean Difference (Final Values)|11.11||||||90.0|8.97|13.24|||||||
1722200|NCT00672984|3170784|Superiority or Other||Mean Difference (Final Values)|0.98||||||90.0|-1.07|3.03|||||||
1722201|NCT00672984|3170785|Superiority or Other||Mean Difference (Final Values)|13.13||||||90.0|9.33|16.93|||||||
1722202|NCT00672984|3170785|Superiority or Other||Mean Difference (Final Values)|-8.08||||||90.0|-11.37|-4.78|||||||
1722203|NCT00672984|3170786|Superiority or Other||Mean Difference (Final Values)|13.87||||||90.0|11.45|16.29|||||||
1722204|NCT00672984|3170786|Superiority or Other||Mean Difference (Final Values)|-2.43||||||90.0|-4.52|-0.34|||||||
1722205|NCT00672958|3170798|Superiority or Other||LS Mean Difference|-0.87||||0.304|2-Sided|95.0|-2.52|0.79|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 5|
1722206|NCT00672958|3170798|Superiority or Other||LS Mean Difference|-0.33||||0.67|2-Sided|95.0|-1.85|1.19|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 4|
1722207|NCT00672958|3170798|Superiority or Other||LS Mean Difference|-0.68||||0.356|2-Sided|95.0|-2.11|0.76|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 3|
1722208|NCT00672958|3170798|Superiority or Other||LS Mean Difference|0.26||||0.701|2-Sided|95.0|-1.07|1.59|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Change from Baseline at Week 2|
1722209|NCT00672958|3170798|Superiority or Other||LS Mean Difference|0.07||||0.901|2-Sided|95.0|-0.97|1.1|||ANCOVA|ANCOVA model with treatment and center as fixed factors and the baseline value as a covariate.||Comparison of change from Baseline at Week 1.|
1722210|NCT00672958|3170799|Superiority or Other||LS Mean Difference|-0.74||||0.407|2-Sided|95.0|-2.48|1.01||Pre-specified sequential statistical testing procedure indicates that when p-value for change from baseline in HAMD-24 at Week 6 >0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|Analysis of covariance (ANCOVA), with treatment and center as fixed factors and baseline HAM-D24 as a covariate.||Change from Baseline in HAM-D24 total score at Week 6 was tested at significance level 0.05. To control for multiplicity, subsequent endpoints were to be tested in a sequential testing procedure at significance level 0.025; as soon as an endpoint in a sequence was non-significant at 0.025, the testing procedure was stopped for all subsequent endpoints in that sequence.|
1722211|NCT00672841|3170811|Superiority or Other||Percent Specificity|52.0||||||95.0|||||||Specificity [0.52]= (True negatives [n=30]/True negatives + false positives [n=58])|The clinical specificity of the BDG test was calculated for both study groups combined|
1722212|NCT00672841|3170811|Superiority or Other||Percent Sensitivity|100.0||||||95.0|||||||Sensitivity = (true positives [n=6]/true positives + false negative [n=6])|The clinic sensitivity of the BDG test was calculated for both study groups combined|
1722213|NCT00672841|3170813|Superiority or Other||Specificity|50.0||||||95.0|||||||Specificity [0.50]= True negatives [n=28]/ True negatives + False positives [56])|Clinical specificity of the BDG test was calculated for the study groups combined|
1722214|NCT00672841|3170813|Superiority or Other||Sensitivity|100.0||||||95.0|||||||Sensitivity [1] = (True positives [n=6]/ True positives + False negatives [n=6])|Clinical sensitivity of the BDG test was calculated for both study groups combined|
1722215|NCT00672737|3170816|Superiority or Other||Slope|-0.0172|||<|0.05|2-Sided|95.0|-0.018|0.0556|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for SaO2: for every 1-%-absolute decrease in the nadir SaO2, the heat pain threshold will additionally increase by 0.0172 'C for every 1-mcg/mL increase in the plasma level of remifentanil.|
1722216|NCT00672737|3170816|Superiority or Other||Slope|-0.0001|||<|0.05|2-Sided|95.0|-0.0001|-0.0001|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for IGFBP-1: for every 1-pg/mL increase in its serum level, the heat pain threshold will additionally decrease by 0.0001 'C for every 1-mcg/mL increase in the plasma level of remifentanil.|
1722218|NCT00672737|3170817|Superiority or Other||Slope|0.0025|||<|0.05|2-Sided|95.0|0.0009|0.0041|||Regression, Linear|Adjusted for body mass index, age of the volunteers, and a binary variable indicating the type (home-based vs. in-laboratory).|Mixed linear regression|Beta for IGFBP-1: for every 1-pg/mL increase in its serum level the cold pain threshold will additionally increase by 0.0025 seconds for every 1-mcg/mL increase in the plasma level of remifentanil.|
1722219|NCT00672633|3170824|Superiority or Other||Mean Difference (Net)|2.3||||0.27||95.0|||||ANOVA|Repeated Measures||No power calculations were conducted for this outcome|
1722220|NCT00672633|3170825|Superiority or Other||Mean Difference (Net)|16.0||||0.06||95.0|||||ANOVA|Repeated Measures||No power calculations done for this outcomes|
1722221|NCT00672633|3170826|Superiority or Other||Mean Difference (Net)|20.0||||0.52||95.0|||||ANOVA|Repeated measures||The study was designed with 80% power to detect a net improvement of Triglyceride elevles with a sample size of 60.|
1722222|NCT00672620|3170838|Superiority or Other||LS Mean Difference|-2.96|Standard Error of the Mean|1.047||0.005|2-Sided|95.0|-5.02|-0.91|||ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.|||
1722223|NCT00672620|3170838|Superiority or Other||LS Mean Difference|-1.54|Standard Error of the Mean|1.038||0.138|2-Sided|95.0|-3.58|0.5|||ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.|||
1722224|NCT00672620|3170838|Superiority or Other||LS Mean Difference|-0.58|Standard Error of the Mean|1.036||0.577|2-Sided|95.0|-2.61|1.46||Pre-specified sequential statistical testing procedure indicates that when p-value >0.05, hierarchical testing stops and for subsequent endpoints in the sequence a nominal p-value is provided.|ANCOVA|ANCOVA with treatment and center as fixed factors, baseline HAM-D24 as covariate.||All statistical tests were 2-sided with 95% confidence intervals (CIs), and with P-values evaluated at the 5% significance level (ie, statistical significance if P<0.05). To control for multiplicity, a pre-specified sequential testing procedure was applied to compare 5 mg and 2.5 mg vortioxetine to placebo; as soon as an endpoint was non-significant at 0.05, the testing procedure stopped for all subsequent endpoints.|
1722225|NCT00672477|3170862|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1722226|NCT00672477|3170863|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1722227|NCT00672256|3170880|Superiority or Other||Mean Difference (Final Values)|0.169|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.|
1722228|NCT00672256|3170881|Superiority or Other||Mean Difference (Final Values)|0.173|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.|
1722229|NCT00672256|3170882|Superiority or Other||Mean Difference (Final Values)|0.104|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.|
1722230|NCT00672256|3170883|Superiority or Other||Mean Difference (Final Values)|0.039|||<|0.05||95.0|||||Paired t-test|||Within group repeated measures design. Null hypothesis is that there will be no difference in percent signal change during active task relative to baseline.|
1722231|NCT00671970|3170896|Superiority or Other|||||||0.008|||||||Wilcoxon (Mann-Whitney)||||
1722232|NCT00671970|3170897|Superiority or Other|||||||0.179|||||||Wilcoxon (Mann-Whitney)||||
1722233|NCT00671970|3170898|Superiority or Other|||||||1|||||||Fisher Exact||||
1722234|NCT00671970|3170899|Superiority or Other|||||||1|||||||Fisher Exact||||
1722235|NCT00671970|3170900|Superiority or Other|||||||1|||||||Fisher Exact||||
1722236|NCT00671970|3170901|Superiority or Other|||||||0.613|||||||Fisher Exact||||
1722237|NCT00671970|3170902|Superiority or Other|||||||1|||||||Fisher Exact||||
1722238|NCT00671060|3170969|Superiority or Other||Risk Ratio (RR)|0.682|||<|0.05|2-Sided|95.0|||||Chi-squared|||Rates of success were compared across study arms. The study was a separate, non-comparative efficacy study. In order to have 80% power (alpha=.05) to demonstrate that each misoprostol regimen was 95%, ± 5%, effective, we enrolled 73 women in each arm of the study, or 146 women total. The sample size also provided 80% power (alpha=.05) to detect a significant difference between treatments should 200μg prove 98% effective and 100μg prove 88% effective.|
1722239|NCT00670800|3170991|Superiority or Other|||||||0.19|||||||t-test, 2 sided||||
1722240|NCT00670800|3170991|Superiority or Other|||||||0.581|||||||t-test, 2 sided||||
1722241|NCT00670800|3170991|Superiority or Other|||||||0.118|||||||t-test, 2 sided||||
1722242|NCT00670800|3170992|Superiority or Other|||||||0.606|||||||t-test, 2 sided||||
1722243|NCT00670800|3170992|Superiority or Other|||||||0.835|||||||t-test, 2 sided||||
1722244|NCT00670800|3170992|Superiority or Other|||||||0.498|||||||t-test, 2 sided||||
1722245|NCT00670800|3170993|Superiority or Other|||||||0.038|||||||t-test, 2 sided||||
1722246|NCT00670800|3170993|Superiority or Other|||||||0.717|||||||t-test, 2 sided||||
1722247|NCT00670800|3170993|Superiority or Other|||||||0.049|||||||t-test, 2 sided||||
1722248|NCT00670800|3170994|Superiority or Other|||||||0.133|||||||t-test, 2 sided||||
1722249|NCT00670800|3170994|Superiority or Other|||||||0.9|||||||t-test, 2 sided||||
1722250|NCT00670800|3170994|Superiority or Other|||||||0.143|||||||t-test, 2 sided||||
1722251|NCT00670709|3171006|Superiority or Other||||||<|0.005|||||||t-test, 2 sided|||HD subjects vs control subjects|
1722252|NCT00670709|3171007|Superiority or Other||||||<|1e-07|||||||t-test, 2 sided||||
1722253|NCT00670488|3171019|Other||GMR|0.133|||||2-Sided|95.0|0.051|0.347||||||"pAkt Geometric Mean Ratio (GMR)~= Day 15 Geometric Mean (GM) ÷ Baseline GM"|
1722254|NCT00670488|3171022|Other||C48hr GMR|1.49||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.|
1722255|NCT00670488|3171022|Other||C48hr GMR|1.86||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.|
1722256|NCT00670488|3171022|Other||C48hr GMR|1.61||||||||||||||The Last Day/Day 1 C48hr GMR was calculated as follows: Last Day C48hr GM ÷ Day 1 C48hr GM.|
1722257|NCT00670488|3171023|Other||Cmax GMR|1.33||||||||||||||The Last Day/Day 1 Cmax GMR was calculated as follows: Last Day Cmax GM ÷ Day 1 Cmax GM.|
1722261|NCT00670488|3171027|Other||C48hr GMR|3.58||||||||||||||"The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.~C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."|
1722262|NCT00670488|3171027|Other||C48hr GMR|4.33||||||||||||||"The Last Day (Day 27)/Day 1 C48hr GMR was calculated as follows: Last Day (Day 27) C48hr GM ÷ Day 1 C48hr GM.~C48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."|
1722263|NCT00670488|3171028|Other||Cmax GMR|2.67||||||||||||||"The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.~Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."|
1722264|NCT00670488|3171028|Other||Cmax GMR|2.59||||||||||||||"The Last Day (Day 27)/Day 1 Cmax GMR was calculated as follows: Last Day (Day 27) Cmax GM ÷ Day 1 Cmax GM.~Cmax GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."|
1722265|NCT00670488|3171029|Other||AUC 0-48hr GMR|3.18||||||||||||||"The Last Day (Day 27)/Day 1 AUC 0-48 hr GMR was calculated as follows: Last Day (Day 27) AUC 0-48hr GM ÷ Day 1 AUC 0-48hr GM.~AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."|
1722266|NCT00670488|3171029|Other||AUC0-48hr GMR|3.26||||||||||||||"The Last Day (Day 27)/Day 1 AUC 0-48 hr Geometric Mean Ratio (GMR) was calculated as follows: Last Day (Day 27) AUC 0-48hr Geometric Mean (GM) ÷ Day 1 AUC 0-48hr GM.~AUC 0-48hr GMR for last dose (Day 27) calculated using only data from participants who completed cycle one dosing as scheduled and had sufficient data for calculation."|
1722267|NCT00670306|3171056|Superiority or Other||Mean Difference (Net)|-5.6|Standard Deviation|7.1|<|0.001|||||||t-test, 2 sided||||
1722268|NCT00670241|3171064|Superiority or Other||Mean Difference (Final Values)|-14.7|||<|0.001|2-Sided|98.33|-22.6|-6.9|||ANOVA||||
1722269|NCT00670241|3171065|Superiority or Other||Odds Ratio (OR)|3.51|||<|0.001|2-Sided|98.33|1.46|8.4|||Cochran-Mantel-Haenszel||||
1722270|NCT00670241|3171066|Superiority or Other||Odds Ratio (OR)|3.42|||<|0.001|2-Sided|95.0|2.05|5.7|||Cochran-Mantel-Haenszel||||
1722271|NCT00670007|3171087|Superiority or Other||Difference in lung density(adjusted P15)|1.787||||0.404|2-Sided|95.0|-2.44|6.014||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.|
1722272|NCT00670007|3171087|Superiority or Other||Difference in lung density(adjusted P15)|-0.151||||0.941|2-Sided|95.0|-4.172|3.87||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.|
1722273|NCT00670007|3171087|Superiority or Other||Difference in lung density(adjusted P15)|0.294||||0.883|2-Sided|95.0|-3.645|4.233||Two-sided P-value|ANCOVA|||Analysis of the percent change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.|
1722274|NCT00670007|3171088|Superiority or Other||Difference in lung density(adjusted P15)|0.019||||0.984|2-Sided|95.0|-1.858|1.895||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for FRC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.|
1722275|NCT00670007|3171088|Superiority or Other||Difference in lung density(adjusted P15)|-0.486||||0.558|2-Sided|95.0|-2.126|1.154||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for TLC) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects.|
1722276|NCT00670007|3171088|Superiority or Other||Difference in lung density(adjusted P15)|-0.53||||0.526|2-Sided|95.0|-2.179|1.12||Two-sided P-value|ANCOVA|||Analysis of the change in lung density (for TLC + FRC combined) from baseline to 2 years was analyzed using an ANCOVA model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect.|
1722277|NCT00670007|3171089|Superiority or Other||Difference in lung density(adjusted P15)|-0.176|||=|0|2-Sided|95.0|-1.09|0.738||A 1-sided P-value < 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being > zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for FRC) was a linear random regression model with country, time since Day 1 [CE1226_4001], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.|
1722278|NCT00670007|3171089|Superiority or Other||Difference in lung density(adjusted P15)|-0.371|||=|0|2-Sided|95.0|-1.159|0.417||A 1-sided P-value < 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% CI being > zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for TLC) was a linear random regression model with country, time since Day 1 [CE1226_4001], and treatment-by-time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.|
1722279|NCT00670007|3171089|Superiority or Other||Difference in lung density(adjusted P15)|-0.279|||=|0|2-Sided|95.0|-1.089|0.53||A 1-sided P-value < 0.025 and a positive estimate of the treatment difference Early Start minus Delayed Start (ie, the lower bound of the 95% confidence interval [CI] being > zero) will indicate superiority of Early Start compared with Delayed Start.|Regression, Linear|||Analysis of the annual rate of change in lung density (for TLC + FRC combined) was a linear random regression model with country, inspiration state, time since Day 1 [CE1226_4001], and treatment-by time interaction as fixed effects and subject and subject-by-time interaction as random coefficients at a 1-sided significance level of 0.025.|
1722322|NCT00667810|3171326|Superiority or Other|||||||0.846|||||||Log Rank|||Not spsecified.|
1722323|NCT00667810|3171327|Superiority or Other|||||||0.675|||||||Log Rank||||
1722324|NCT00667810|3171327|Superiority or Other|||||||0.079|||||||Log Rank||||
1722280|NCT00669864|3171133|Superiority or Other||Estimated mean|-1.303|Standard Error of the Mean|0.056|<|0.0001||95.0|-1.414|-1.192||A significant mean HbA1c decrease was to be declared if H0 is rejected at a significance level of 2.5%.|t-test, 1 sided|||The null hypothesis (H0): HbA1c after 16 weeks – HbA1c at baseline ≥ 0% against the alternative hypothesis (H1): HbA1c after 16 weeks – HbA1c at baseline < 0%. If H0 rejected at a significance level of 2.5%, declare a significant mean HbA1c decrease|
1722281|NCT00669331|3171164|Superiority or Other||Rate ratio|0.61||||0.0928|2-Sided|95.0|0.34|1.09|||Negative binomial regression||||
1722282|NCT00669331|3171171|Superiority or Other||Mean Difference (Net)|7.56||||0.6677|2-Sided|95.0|-27.01|42.13|||Mixed Models Analysis|Model of absolute change from baseline in FEV1. Model includes terms for treatment, visit, trt*visit, region and baseline value|ls mean difference Mannitol-Control||
1722283|NCT00669331|3171172|Superiority or Other||LS mean diff across post-baseline visits|-0.44||||0.1159|2-Sided|95.0|-0.99|0.11|||Mixed Models Analysis|Model includes treatment, visit, treatment*visit, region and baseline ESS score|Negative change indicates an improvement in ESS score. Difference calculated Mannitol - Control.||
1722284|NCT00669331|3171173|Superiority or Other||ls mean difference across 52 weeks|2.76||||0.0355|2-Sided|95.0|0.19|5.33|||Mixed Models Analysis|Model includes treatment, visit, treatment*visit, region and baseline sputum weight (g).|Difference mannitol-control||
1722285|NCT00669331|3171174|Superiority or Other||Rate ratio|0.88||||0.3602|2-Sided|95.0|0.67|1.16|||Negative binomial model|treatment, region and baseline pulmonary exacerbation rate as predictors, and with log of follow-up time as the offset variable||Analysed using a negative binomial model with treatment, region and baseline pulmonary exacerbation rate as predictors, and with log of follow-up time as the offset variable|
1722286|NCT00669331|3171175|Superiority or Other||Hazard Ratio (HR)|0.78||||0.0218|2-Sided|95.0|0.63|0.96|||Regression, Cox|Cox regression model was stratified by region and baseline PE rate|||
1722287|NCT00669331|3171176|Superiority or Other||Rate ratio|0.91||||0.2754|2-Sided|95.0|0.77|1.08|||Negative binomial regression model|Negative binomial regression model with treatment, region and baseline pulmonary exacerbation rate as predictors, log follow-up as offset|Rate ratio is for mannitol vs control.||
1722288|NCT00669331|3171177|Superiority or Other||LS mean difference across the 52 weeks|-2.4||||0.0457|2-Sided|95.0|-4.76|-0.05|||Mixed model repeated measures analysis|Model included treatment, visit, treatment*visit, region and baseline SGRQ Total score.|difference calculated Mannitol-control. Negative difference is in favour of mannitol since lower scores indicate improved quality of life.||
1722289|NCT00669331|3171178|Superiority or Other||Rate Ratio Mannitol:Control|0.92||||0.3115|2-Sided|95.0|0.78|1.08|||Negative binomial regression model|Negative binomial regression model with treatment, region and baseline PE rate as predictors and log of follow-up time as an offset variable|For rate ratio, Mannitol rate is the numerator, Control rate is the denominator||
1722290|NCT00669214|3171198|Superiority or Other|||||||0.0224|||||||Wilcoxon rank sum||||
1722291|NCT00669214|3171200|Superiority or Other||Difference in mean change from Day 0|1.19||||0.0435||95.0|-0.161|2.532|||Student T-test||||
1722292|NCT00669214|3171202|Superiority or Other||Difference in mean change from Day 0|3.33||||0.1816||95.0|-2.811|9.471|||Student T-test||||
1722293|NCT00669214|3171204|Superiority or Other||Difference in proportion|0.228||||0.0366||95.0|0.003|0.452|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.|||
1722294|NCT00669214|3171206|Superiority or Other||Difference in proportion|0.155||||0.2404||95.0|-0.072|0.388|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.|||
1722295|NCT00669214|3171208|Superiority or Other||Difference in proportion|0.163||||0.1054||95.0|-0.063|0.393|||Fisher Exact|The p-value was based on the Fisher exact test for a 2x2 contingency table.|||
1722296|NCT00669032|3171235|Superiority or Other|||||||0.9129|||||||Chi-squared||||
1722297|NCT00669032|3171236|Superiority or Other|||||||0.002|||||||Chi-squared||||
1722298|NCT00669032|3171237|Superiority or Other|||||||0.023|||||||Chi-squared||||
1722299|NCT00669032|3171238|Superiority or Other|||||||0.025|||||||Chi-squared||||
1722300|NCT00669032|3171239|Superiority or Other|||||||0.021|||||||Chi-squared||||
1722301|NCT00669032|3171240|Superiority or Other|||||||0.002|||||||Chi-squared||||
1722302|NCT00669032|3171241|Superiority or Other|||||||0.049|||||||Chi-squared||||
1722303|NCT00669032|3171242|Superiority or Other|||||||0.049|||||||Chi-squared||||
1722304|NCT00669032|3171243|Superiority or Other|||||||0.03|||||||Chi-squared||||
1722305|NCT00669032|3171244|Superiority or Other|||||||0.525|||||||Chi-squared||||
1722306|NCT00669032|3171245|Superiority or Other|||||||0.004|||||||Chi-squared||||
1722307|NCT00667875|3171312|Superiority||||||<|0.05|||||||ANOVA|f 3.2 df 2||Anova across three groups|
1722308|NCT00667875|3171313|Superiority|Anova across all three treatment groups|||||<|0.05|||||||ANOVA|Naltrexone or naltrexone placebo pills taken F=3.9 df 2 Aripiprazole or aripiprazole placebo pills taken F=4.6 df 2|||
1722309|NCT00667875|3171314|Superiority|||||||0.03||||||The p value represents variation of the total 16 week trial over all three groups.|Mixed Models Analysis|||Analyzed as a mixed model (SPSS linear mixed) with an unstructured variance/covariance and baseline percent heavy drinking days as a covariate|
1722310|NCT00667875|3171315|Superiority|||||||0.49||||||The p value represents variation of the total 16 week trial over all three groups.|Mixed Models Analysis|||Analyzed as a mixed model, Group by time (4 time blocks) with an unstructured variance/covariance matrix. Baseline drinks per day was used as a covariate.|
1722311|NCT00667810|3171319|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.564|2-Sided|95.0|-0.78|0.43|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a REML based MMRM.|
1722312|NCT00667810|3171319|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.238|2-Sided|95.0|-0.96|0.24|||Mixed Models Analysis|||Change in CDR-SOB total score was analyzed using a REML based MMRM.|
1722313|NCT00667810|3171320|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.257|2-Sided|95.0|-0.79|0.21|||Mixed Models Analysis|||Change in DS score was analyzed using a REML based MMRM.|
1722314|NCT00667810|3171320|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.516|2-Sided|95.0|-0.65|0.33|||Mixed Models Analysis|||Change in DS score was analyzed using a REML based MMRM.|
1722331|NCT00667810|3171331|Superiority or Other||Mean Difference (Final Values)|1.06||||0.423|2-Sided|95.0|-1.54|3.66|||Mixed Models Analysis|||Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.|
1722332|NCT00667810|3171331|Superiority or Other||Mean Difference (Final Values)|1.01||||0.437|2-Sided|95.0|-1.55|3.57|||Mixed Models Analysis|||Change in MRI BBSI was analyzed using a REML based MMRM. The number of participants gave 90% power to detect a 5.05-cm3 advantage for a bapineuzumab dose group over placebo on reduction in brain volume as measured by the BBSI at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.|
1722333|NCT00667810|3171332|Superiority or Other||Mean Difference (Final Values)|-7.18||||0.085|2-Sided|95.0|-15.38|1.02|||ANCOVA|||The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 15 ng/L advantage in p-tau for a bapineuzumab dose group over placebo at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.|
1722334|NCT00667810|3171333|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.654|2-Sided|95.0|-0.15|0.09|||Mixed Models Analysis|||The analysis is based on the pooled bapineuzumab (with subjects in the bapineuzumab 0.5 and 1.0 mg/kg groups combined) treatment difference estimated at Week 71. The number of participants gave 90% power to detect a 0.186 unit advantage for a bapineuzumab dose group over placebo for PiB PET binding at Week 71. The calculations were based on 2-sided tests with alpha set at 0.05 and the use of the Hochberg procedure to control for multiplicity for 2 individual doses.|
1722335|NCT00667810|3171334|Superiority or Other||Mean Difference (Final Values)|1.01||||0.623|2-Sided|95.0|-3.04|5.07||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.|
1722336|NCT00667810|3171334|Superiority or Other||Mean Difference (Final Values)|1.51||||0.459|2-Sided|95.0|-2.48|5.49||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in DAD total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 6.56 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.|
1722337|NCT00667810|3171335|Superiority or Other||Mean Difference (Final Values)|0.19||||0.848|2-Sided|95.0|-1.73|2.1||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in ADAS-Cog/11 total score was analyzed using a REML based MMRM. The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.|
1722338|NCT00667810|3171335|Superiority or Other||Mean Difference (Final Values)|-1.83||||0.057|2-Sided|95.0|-3.71|0.05||The p-value is not adjusted for multiple comparison. The Hochberg approach is used to control for multiplicity between the two dose levels (0.5 mg/kg and 1.0 mg/kg) of bapineuzumab.|Mixed Models Analysis|||Change from baseline in ADAS-Cog/11 total score was analyzed using a restricted maximum likelihood (REML) based mixed model for repeated-measures (MMRM). The number of participants in each group provided approximately 90% power to detect a 2.65 point advantage at Week 78. This calculation was based on a 2-sided test with alpha set at 0.05, the use of the Hochberg procedure to control for multiplicity.|
1722339|NCT00667745|3171336|Superiority||Mean Difference (Net)|0.92||||0.49|2-Sided|||||Value shown above describes emergent suicidal ideation for participants with baseline MSSI = 0. P=.36 describes exacerbation of baseline suicidal ideation for those with baseline MSSI > 0.|Mixed Models Analysis||||
1722340|NCT00667745|3171337|Superiority||Mean Difference (Net)|0.02||||0.88|2-Sided||||||Mixed Models Analysis||||
1722341|NCT00667745|3171338|Superiority||Mean Difference (Net)|0.45||||0.5|2-Sided||||||Mixed Models Analysis||||
1722342|NCT00667745|3171339|Superiority||Chi-squared|0.0||||0.967|2-Sided||||||Chi-squared||||
1722343|NCT00667745|3171340|Superiority||F value, main effect|0.94||||0.33|2-Sided||||||Mixed Models Analysis||||
1722344|NCT00667693|3171347|Superiority or Other||Hazard Ratio (HR)|0.35|||<|0.001|2-Sided|95.0|0.23|0.55|||Regression, Cox||||
1722345|NCT00667602|3171352|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Ratio|1.33|||||2-Sided|95.0|0.96|1.83||||||For comparison of the Geometric Mean Titers at one month postvaccination at 12 months of age, MenACWY–CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.|
1722346|NCT00667602|3171354|Non-Inferiority or Equivalence|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-5.0|||||2-Sided|95.0|-11.0|1.0||||||For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.|
1722347|NCT00667602|3171354|Non-Inferiority or Equivalence|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-10.0|||||2-Sided|95.0|-17.0|-4.0||||||For the comparisons to MenC based on percentages of subjects with response (four-fold rise in titers), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.|
1722348|NCT00667602|3171354|Non-Inferiority or Equivalence|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|-13.0|||||2-Sided|95.0|-22.0|-5.0||||||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.|
1722349|NCT00667602|3171354|Non-Inferiority or Equivalence|PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage Difference|4.0|||||2-Sided|95.0|-3.0|11.0||||||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.|
1722350|NCT00667602|3171354|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|1.0|||||2-Sided|95.0|-2.0|4.0||||||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.|
1722351|NCT00667602|3171354|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|31.0|||||2-Sided|95.0|24.0|39.0||||||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:128, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.|
1722352|NCT00667602|3171354|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|-5.0|||||2-Sided|95.0|-11.0|1.0||||||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.|
1722353|NCT00667602|3171354|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|2.0|||||2-Sided|95.0|-2.0|7.0||||||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.|
1722354|NCT00667602|3171354|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|2.0|||||2-Sided|95.0|-3.0|6.0||||||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, one month postvaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.|
1722355|NCT00667602|3171354|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|71.0|||||2-Sided|95.0|63.0|78.0||||||For the comparisons to MenC based on percentages of subjects with response (rSBA ≥1:8, prevaccination), MenACWY-CRM197 was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY-CRM197 and MenC in the percentage of subjects with response against serogroup C was greater than -10%.|
1722356|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-6.0|||||2-Sided|95.0|-13.0|0.0||||||Immunogenicity of PCV7 (PNC23F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722357|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-9.0|||||2-Sided|95.0|-17.0|-1.0||||||Immunogenicity of PCV7 (PNC19F, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722358|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-15.0|||||2-Sided|95.0|-24.0|-6.0||||||Immunogenicity of PCV7 (PNC18C, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722359|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||2-Sided|95.0|-4.0|3.0||||||Immunogenicity of PCV7 (PNC14, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722360|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-3.0|||||2-Sided|95.0|-10.0|3.0||||||Immunogenicity of PCV7 (PNC 9V, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722361|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||2-Sided|95.0|-11.0|0.0||||||Immunogenicity of PCV7 (PNC6B, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722362|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||2-Sided|95.0|-12.0|4.0||||||Immunogenicity of PCV7 (PNC4, one month postvaccination) given concomitantly with two doses of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722363|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||2-Sided|95.0|-12.0|1.0||||||Immunogenicity of PCV7 (PNC 23F, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722364|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-10.0|||||2-Sided|95.0|-17.0|-2.0||||||Immunogenicity of PCV7 (PNC 19F, one month postvaccination), given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722365|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-10.0|||||2-Sided|95.0|-19.0|-2.0||||||Immunogenicity of PCV7( PNC 18C, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722366|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||2-Sided|95.0|-3.0|3.0||||||Immunogenicity of PCV7 (PNC 14, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722367|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC).|Percentage difference|-5.0|||||2-Sided|95.0|-11.0|2.0||||||Immunogenicity of PCV7(PnC 9V, one month postvaccination) given concomitantly with MenACWY-CRM197 or MenC was considered non-inferior, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than -10%.|
1722368|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-6.0|||||2-Sided|95.0|-12.0|-1.0||||||Immunogenicity of PCV7(PNC 6B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722369|NCT00667602|3171359|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-5.0|||||2-Sided|95.0|-13.0|3.0||||||Immunogenicity of PCV7 (PNC4, one month postvaccination)given concomitantly with one dose of MenACWY was considered non-inferior to PCV7 given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722370|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC)|Percentage Difference|-1.0|||||2-Sided|95.0|-4.0|3.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722371|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||2-Sided|95.0|-3.0|3.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Hep B, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722372|NCT00667602|3171360|Non-Inferiority or Equivalence|PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|-1.0|||||2-Sided|95.0|-4.0|2.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722373|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|1.0|||||2-Sided|95.0|-2.0|4.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 1.0 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722374|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||2-Sided|95.0|-2.0|2.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722460|NCT00666757|3171546|Superiority or Other|||||||0.003|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.|
1722375|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||2-Sided|95.0|-2.0|2.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Anti- PRP ≥ 0.15 μg/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722376|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage Difference|0.0|||||2-Sided|95.0|-2.0|3.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Polio 3, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722377|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||2-Sided|95.0|-3.0|3.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (polio 3, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722378|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||2-Sided|95.0|-3.0|2.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722379|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||2-Sided|95.0|-2.0|3.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (polio 2, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722380|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||2-Sided|95.0|-2.0|4.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722381|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||2-Sided|95.0|-2.0|4.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (polio 1, one month postvaccination), given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722382|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-1.0|||||2-Sided|95.0|-6.0|3.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722383|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|-2.0|||||2-Sided|95.0|-6.0|3.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722384|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||2-Sided|95.0|-2.0|2.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, for any of the antigens, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722385|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||2-Sided|95.0|-2.0|2.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Tetanus Toxin ≥ 0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722386|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||2-Sided|95.0|-3.0|4.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722461|NCT00666757|3171547|Superiority or Other|||||||0.001|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.|
1722462|NCT00666757|3171548|Superiority or Other|||||||0.002|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.|
1722387|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|1.0|||||2-Sided|95.0|-3.0|5.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥1.0 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722388|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||2-Sided|95.0|-2.0|2.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with one dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722389|NCT00667602|3171360|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY - PConcomitant Vaccine+MenC).|Percentage difference|0.0|||||2-Sided|95.0|-2.0|2.0||||||Immunogenicity of DTPa-IPV-HepB-Hib (Anti-Diptheria Toxin ≥0.1 IU/mL, one month postvaccination) given concomitantly with two dose of MenACWY was considered non-inferior to DTPa-IPV-HepB-Hib given concomitantly with one dose of MenC, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response was greater than the cut-off level specified for that antigen was greater than -10%.|
1722390|NCT00667602|3171361|Non-Inferiority or Equivalence|(GMTMenACWY/GMTMenjugate > 0.5).|Ratio|8.1|||||2-Sided|95.0|6.35|10.0||||||For comparison of the GMTs (one month postvaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5.|
1722391|NCT00667602|3171361|Non-Inferiority or Equivalence|(GMTMenACWY/GMTMenjugate > 0.5).|Ratio|10.0|||||2-Sided|95.0|8.43|13.0||||||For comparison of the GMTs (prevaccination), MenACWY was determined to be non-inferior to MenC if the lower limit of the two-sided 95% CI for the ratio of the MenACWY to MenC GMTs for serogroup C was greater than 0.5 .|
1722392|NCT00667602|3171363|Non-Inferiority or Equivalence|(GMTMenACWY/GMTMenC > 0.5).|Ratio|0.73|||||2-Sided|95.0|0.57|0.93||||||For comparison of the Geometric Mean Titers, one month postvaccination at 12 months of age, MenACWY–CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.|
1722393|NCT00667602|3171363|Non-Inferiority or Equivalence|(GMTMenACWY/GMTMenC > 0.5).|Ratio|0.92|||||2-Sided|95.0|0.76|1.12||||||For comparison of the Geometric Mean Titers, prevaccination at 12 months of age, MenACWY–CRM197 was determined to be non-inferior to MenC if the lower limit of the 2-sided 95% CI for the ratio of the MenACWY-CRM197 to MenC Geometric Mean Titers for serogroup C was greater than 0.5.|
1722394|NCT00667602|3171365|Non-Inferiority or Equivalence|(PMenACWY – PMenC > -10%).|Mean Difference (Final Values)|1.0|||||2-Sided|95.0|-2.0|5.0||||||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than –10%.|
1722395|NCT00667602|3171365|Non-Inferiority or Equivalence|(PMenACWY – PMenC > -10%).|Mean Difference (Final Values)|80.0|||||2-Sided|95.0|73.0|86.0||||||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:4, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than –10%.|
1722396|NCT00667602|3171365|Non-Inferiority or Equivalence|(PMenACWY – PMenC > -10%).|Mean Difference (Net)|7.0|||||2-Sided|95.0|3.0|13.0||||||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, one month postvaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than –10%.|
1722397|NCT00667602|3171365|Non-Inferiority or Equivalence|(PMenACWY – PMenC > -10%).|Mean Difference (Final Values)|72.0|||||2-Sided|95.0|64.0|79.0||||||Comparisons to MenC were based on the percentages of subjects with response (hSBA ≥1:8, prevaccination) to serogroup C. MenACWY was determined to be noninferior to MenC if the lower limit of the two-sided 95% CI for the difference between MenACWY and MenC in the percentage of subjects with response towards serogroup C was greater than –10%.|
1722398|NCT00667602|3171366|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Percentage difference|-7.0|||||2-Sided|95.0|-13.0|-2.0||||||The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥ 1:4 for serogroup C at 1 month following the 12 months vaccination was greater than -10%.|
1722399|NCT00667602|3171367|Non-Inferiority or Equivalence|(PConcomitant Vaccine + MenACWY-CRM - PConcomitant Vaccine + MenC)|Percentage Difference|-8.0|||||2-Sided|95.0|-15.0|-1.0||||||The primary criterion for immunogenicity was that the lower limit of the two-sided 95% confidence interval (CI) for the difference between one dose of MenACWY-CRM197 and MenC in the percentage of subjects with hSBA ≥1:8 for serogroup C at 1 month following the 12 months vaccination was greater than -10% .|
1722400|NCT00667459|3171393|Superiority or Other|||||||0.273||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the hospital stay in two treatment groups was assessed.|
1722401|NCT00667459|3171394|Superiority or Other|||||||0.769||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the blood loss in two treatment groups was assessed.|
1722402|NCT00667459|3171395|Superiority or Other|||||||0.013||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|||Superiority comparison of the operative time in two treatment groups was assessed.|
1722463|NCT00666757|3171549|Superiority or Other|||||||0.001|||||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.|
1725639|NCT00614380|3178332|Superiority or Other||Odds Ratio (OR)|0.91||||||95.0|0.34|2.41|||||||
1722403|NCT00667459|3171397|Superiority or Other|||||||0.992||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.|
1722404|NCT00667459|3171397|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.105||||1|2-Sided|95.0|0.02|0.19||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1722405|NCT00667459|3171398|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.047||||0.936|2-Sided|95.0|-0.113|0.021||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1722406|NCT00667459|3171399|Superiority or Other|||||||0.845||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.|
1722407|NCT00667459|3171399|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.019||||1|2-Sided|95.0|-0.018|0.058||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1722408|NCT00667459|3171400|Superiority or Other|||||||0.273||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.|
1722409|NCT00667459|3171400|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.01||||1|2-Sided|95.0|-0.043|0.023||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1722410|NCT00667459|3171401|Superiority or Other|||||||0.097||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.|
1722411|NCT00667459|3171401|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.034||||0.992|2-Sided|95.0|-0.085|0.021||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1722464|NCT00666757|3171550|Superiority or Other|||||||0.09|||||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.|
1725640|NCT00614380|3178332|Superiority or Other||Odds Ratio (OR)|0.08||||||95.0|0.06|0.13|||||||
1722412|NCT00667459|3171402|Superiority or Other|||||||0.999||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.|
1722413|NCT00667459|3171402|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.099||||1|2-Sided|95.0|0.038|0.161||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1722414|NCT00667459|3171403|Superiority or Other|||||||0.912||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.|
1722415|NCT00667459|3171403|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.048||||1|2-Sided|95.0|-0.02|0.118||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the success rates of NDI in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 – p0 > -d | data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational group will be claimed for this endpoint."|
1722416|NCT00667459|3171404|Superiority or Other|||||||0.736||||||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.|
1722417|NCT00667459|3171404|Non-Inferiority or Equivalence|The non-inferiority margin is 0.1.|Risk Difference (RD)|0.032||||0.995|2-Sided|95.0|-0.07|0.134||The posterior probably of non-inferiority was calculated and presented instead of the p-value.|Bayesian logistic model|The propensity score method was used to adjust possible effects on outcomes caused by differences in baseline characteristic due to non-randomization.|The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 – p0 > -d | data) be at least 0.95, then the null noninferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1722418|NCT00667368|3171426|Superiority or Other (legacy)||||||<|0.001|||||||Fisher Exact||||
1722419|NCT00667368|3171427|Superiority or Other (legacy)||Risk Difference (RD)|-0.9||||0.754|2-Sided|95.0|-12.0|10.1|||Two-sample test, Poisson||The risk difference reflects the treatment arm minus the control arm. The units are the number of positive tests for chlamydia and gonorrhea per 100 person-years.||
1722420|NCT00667342|3171456|Other|The association between response and Ve at Week 10 was evaluated.||||||0.0863|||||||Logistic Regression||||
1722421|NCT00667342|3171457|Other|The association between response and Vp at Week 10 was evaluated.||||||0.0573|||||||Logistic Regression||||
1722422|NCT00667342|3171458|Other|The association between response and Ktrans at Week 10 was evaluated.||||||0.0863|||||||Logistic Regression||||
1722423|NCT00667095|3171484|Superiority or Other|||||||0.038|||||||t-test, 2 sided|||Change between baseline and 3 months|
1722424|NCT00667095|3171484|Superiority or Other|||||||0.31|||||||t-test, 2 sided|||Change between baseline and one month|
1722425|NCT00667095|3171485|Superiority or Other|||||||0.2|||||||t-test, 2 sided|||Change from baseline to 3 months.|
1722426|NCT00667095|3171485|Superiority or Other|||||||0.67|||||||t-test, 2 sided|||Change from baseline to one month|
1722427|NCT00667095|3171486|Superiority or Other|||||||0.77|||||||t-test, 2 sided|||Change from baseline to 3 months.|
1722428|NCT00667095|3171486|Superiority or Other|||||||0.18|||||||t-test, 2 sided|||Change from baseline to 1 month|
1722429|NCT00667095|3171487|Superiority or Other|||||||0.15|||||||t-test, 2 sided|||Change from baseline to 3 months.|
1722430|NCT00667095|3171487|Superiority or Other|||||||0.42|||||||t-test, 2 sided|||Change from baseline to 1 month.|
1722431|NCT00667095|3171488|Superiority or Other|||||||0.12|||||||t-test, 2 sided|||Change from baseline to 3 months.|
1722432|NCT00667095|3171488|Superiority or Other|||||||0.051|||||||t-test, 2 sided|||Change from baseline to 1 month.|
1722433|NCT00667095|3171489|Superiority or Other|||||||0.036|||||||t-test, 2 sided|||Change from baseline to 3 months.|
1722434|NCT00667095|3171489|Superiority or Other|||||||0.024|||||||t-test, 2 sided|||Change from baseline to 1 month.|
1722533|NCT00666406|3171630|Superiority or Other||Ratio of the geometric means|1.008|||||2-Sided|90.0|0.969|1.05|||||||
1725641|NCT00614380|3178332|Superiority or Other||Odds Ratio (OR)|0.31||||||95.0|0.12|0.81|||||||
1722435|NCT00666978|3171492|Other||Odds Ratio (OR)|2.82|||<|0.05|2-Sided|||||Analysis relied on examining quit rates using linear regression, where the hydroxybupropion was a significant predictor of smoking cessation. CYP2B6 genotype was not a direct significant predictor of cessation in either the placebo or bupropion arm.|Regression, Linear||Bupropion adherent individuals with higher hydroxybupropion levels were more likely to be abstinent at Weeks 3, 7 and 26 compared to individuals with lower hydroxybupropion levels.||
1722436|NCT00666978|3171493|Other||Odds Ratio (OR)|0.97||||0.0022|2-Sided|95.0|0.95|0.99||This reflects Week 7.|Regression, Logistic||This reflects Week 7.||
1722437|NCT00666978|3171494|Superiority|The x2 test was used to determine whether there was a difference between treatment groups (bupropion SR vs placebo) in verified 7-day point prevalence abstinence at week 26, imputing the missing participants as smokers.|Odds Ratio (OR)|1.39||||0.23|2-Sided|95.0|0.82|2.35||All tests of statistical significance were two-sided, and all P values less than .05 were considered statistically significant.|t-test, 2 sided||Raw proportions were used to estimate the verified cessation rate in each group and corresponding odds ratio along with its 95% confidence interval .|Based on our previous studies, sample size was determined a priori assuming a two-sided x2 test with a type I error rate of .05, a power of 80%, and a cotinine-verified abstinence rate of 15% in the placebo group and 25% in the bupropion SR group at week 26, with the assumption that those lost to follow-up would be imputed as smokers.|
1722438|NCT00666926|3171509|Superiority or Other||Ratio (percent) test / reference|496.63|||||2-Sided|90.0|206.24|1195.92|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.|
1722439|NCT00666926|3171510|Superiority or Other||Ratio (percent) test / reference|315.72|||||2-Sided|90.0|227.6|437.97|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.|
1722440|NCT00666926|3171511|Superiority or Other||Ratio (percent) test / reference|155.66|||||2-Sided|90.0|109.66|220.95|||||Ratio of adjusted geometric means Day 21 versus Day 1. Values have been transformed from the log scale.|Participants in the PF-00562271 125 mg BID cohort who received MDZ (test) administered prior to PF-00562271 (reference) dosing.|
1722441|NCT00666835|3171527|Equivalence|Therapeutic equivalence was defined as the two-sided 95 % confidence interval of the difference between the two treatment groups lying entirely in the interval –0.5 to 0.5 g/dL. The confidence interval of the difference was calculated based on the least square means (LSMEANS) from an analysis of co-variance model including factors treatment, center, mean baseline Hb level (<11.5 and T11.5 g/dL) as factors and change of the mean weekly dose as a covariate.|Difference LSM of Epo Hexal & Erypo|0.189|||||2-Sided|95.0|-0.039|0.418|||||||
1722442|NCT00666835|3171528|Equivalence|Therapeutic equivalence was defined as the two-sided 95 % confidence interval of the difference between the two treatment groups lying entirely in the interval –0.5 to 0.5 g/dL. The confidence interval of the difference was calculated based on the least square means (LSMEANS) from an analysis of co-variance model including factors treatment, center, mean baseline Hb level (<11.5 and T11.5 g/dL) as factors and change of the mean weekly dose as a covariate.|Point estimate of difference (ANCOVA)|0.084|||||2-Sided|95.0|-0.17|0.338|||||||
1722443|NCT00666757|3171529|Superiority or Other|||||||0.53|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.|
1722444|NCT00666757|3171530|Superiority or Other|||||||0.002|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.|
1722445|NCT00666757|3171531|Superiority or Other|||||||0.16||||||Between group P-value|ANCOVA|||Transformed Absolute Score|
1722446|NCT00666757|3171532|Superiority or Other|||||||0.12||||||Between group P-value|ANCOVA|||Transformed absolute score|
1722447|NCT00666757|3171533|Superiority or Other|||||||0.32|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.|
1722448|NCT00666757|3171534|Superiority or Other|||||||0.97|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.|
1722449|NCT00666757|3171535|Superiority or Other|||||||0.01|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.|
1722450|NCT00666757|3171536|Superiority or Other|||||||0.02|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.|
1722451|NCT00666757|3171537|Superiority or Other|||||||0.34||||||Between group P-value|ANCOVA||||
1722452|NCT00666757|3171538|Superiority or Other|||||||0.07||||||Between group P-value|ANCOVA||||
1722453|NCT00666757|3171539|Superiority or Other|||||||0.01|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.|
1722454|NCT00666757|3171540|Superiority or Other|||||||0.002|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.|
1722455|NCT00666757|3171541|Superiority or Other|||||||0.03|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.|
1722456|NCT00666757|3171542|Superiority or Other|||||||0.03|||||||Mixed Models Analysis|||Only those patients who had at least moderate pain at baseline (defined as baseline BPI Average 24-Hour Pain Score greater than or equal to 3). Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.|
1722457|NCT00666757|3171543|Superiority or Other|||||||0.2|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.|
1722458|NCT00666757|3171544|Superiority or Other|||||||0.02|||||||Mixed Models Analysis|||Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.|
1722459|NCT00666757|3171545|Superiority or Other|||||||0.01|||||||Mixed Models Analysis|||Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.|
1725642|NCT00614380|3178332|Superiority or Other||Odds Ratio (OR)|0.34||||||95.0|0.22|0.53|||||||
1722465|NCT00666757|3171551|Superiority or Other|||||||0.03|||||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). Repeated Measures Analysis. The analysis will contrast the remission remission rates at 12-week endpoint.|
1722466|NCT00666757|3171552|Superiority or Other|||||||0.07|||||||Mixed Models Analysis|||Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-week endpoint.|
1722467|NCT00666757|3171553|Superiority or Other|||||||0.26|||||||Mixed Models Analysis|||Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the remission rates at 12 week endpoint between treatment groups.|
1722468|NCT00666718|3171555|Superiority or Other||LS Mean Difference|2.18|||||2-Sided|95.0|-8.33|12.68|||||||
1722469|NCT00666718|3171556|Superiority or Other||LS Mean Difference|-0.16|||||2-Sided|95.0|-0.86|0.55|||||||
1722470|NCT00666718|3171558|Superiority or Other|||||||0.623||||||p-value is for >=1 severe hypoglycemic episode.|Fisher Exact||||
1722471|NCT00666718|3171558|Superiority or Other|||||||0.2094||||||p-value is for >=1 non-nocturnal hypoglycemic episode.|Fisher Exact||||
1722472|NCT00666718|3171558|Superiority or Other|||||||0.1727||||||p-value is for >=1 nocturnal hypoglycemic episode.|Fisher Exact||||
1722473|NCT00666718|3171558|Superiority or Other|||||||0.1701||||||p-value is for >=1 hypoglycemic episode.|Fisher Exact||||
1722474|NCT00666718|3171559|Superiority or Other||LS Mean Difference|-0.01|||||2-Sided|95.0|-0.14|0.12|||||||
1722475|NCT00666718|3171559|Superiority or Other||LS Mean Difference|-0.4|||||2-Sided|95.0|-0.86|0.06|||||||
1722476|NCT00666718|3171559|Superiority or Other||LS Mean Difference|-0.45|||||2-Sided|95.0|-1.06|0.16|||||||
1722477|NCT00666718|3171559|Superiority or Other||LS Mean Difference|-0.04|||||2-Sided|95.0|-0.2|0.11|||||||
1722478|NCT00666718|3171559|Superiority or Other||LS Mean Difference|-0.53|||||2-Sided|95.0|-1.19|0.12|||||||
1722479|NCT00666718|3171560|Superiority or Other|||||||0.9122||||||p-value is for Post-dinner.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+ treatment*country (Mediterranean, rest of Europe)|||
1722480|NCT00666718|3171560|Superiority or Other|||||||0.6448||||||p-value is for Post-lunch.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment*country (Mediterranean, rest of Europe)|||
1722481|NCT00666718|3171560|Superiority or Other|||||||0.7523||||||p-value is for Post-breakfast.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment*country (Mediterranean, rest of Europe)|||
1722482|NCT00666718|3171560|Superiority or Other|||||||0.5568||||||p-value is for Fasting.|ANCOVA|Glycemic variability = Treatment+country grouping (Mediterranean, rest of Europe)+treatment*country (Mediterranean, rest of Europe)|||
1722483|NCT00666718|3171561|Superiority or Other||LS Mean Difference|0.14|||||2-Sided|95.0|-0.67|0.96|||||||
1722484|NCT00666718|3171561|Superiority or Other||LS Mean Difference|0.46|||||2-Sided|95.0|-0.41|1.34|||||||
1722485|NCT00666718|3171561|Superiority or Other||LS Mean Difference|-0.05|||||2-Sided|95.0|-0.93|0.83|||||||
1722486|NCT00666718|3171561|Superiority or Other||LS Mean Difference|0.47|||||2-Sided|95.0|-0.46|1.4|||||||
1722487|NCT00666718|3171561|Superiority or Other||LS Mean Difference|-0.29|||||2-Sided|95.0|-1.15|0.57|||||||
1722488|NCT00666718|3171561|Superiority or Other||LS Mean Difference|0.26|||||2-Sided|95.0|-0.66|1.19|||||||
1722489|NCT00666718|3171561|Superiority or Other||LS Mean Difference|0.37|||||2-Sided|95.0|-0.43|1.17|||||||
1722490|NCT00666718|3171562|Superiority or Other|||||||0.1213||||||p-value is for HbA1c <=6.5%|Fisher Exact||||
1722491|NCT00666718|3171562|Superiority or Other|||||||0.1333||||||p-value is for HbA1c <7.0%.|Fisher Exact||||
1722492|NCT00666718|3171563|Superiority or Other|||||||0.107||||||p-value is for Week 24 Change.|Mixed Models Analysis|Change from baseline=Treatment+country+baseline HbA1c+week+treatment*country+treatment*week+baseline HbA1c*treatment (unstructured covariance used).|||
1722493|NCT00666718|3171563|Superiority or Other|||||||0.458||||||p-value is for Week 12 Change.|Mixed Models Analysis|Change from baseline=Treatment+country+baseline HbA1c+week+treatment*country+treatment*week+baseline HbA1c*treatment (unstructured covariance used).|||
1722494|NCT00666718|3171564|Non-Inferiority or Equivalence|"Assuming a drop-out rate after randomization of approximately 15%, the remaining 160 patients in each treatment group should allow confirmation of noninferiority with no true treatment difference and a noninferiority limit of 0.4% using the upper limit of a 2-sided 95% confidence interval (“insulin lispro protamine suspension + insulin lispro minus “insulin glargine+insulin lispro”) at a significance level of 0.025 with 90% power."|Mean Difference (Final Values)|0.1|||||2-Sided|95.0|-0.11|0.31|||||||
1722495|NCT00666705|3171565|Superiority or Other||ratio (percent)|72.42||||||90.0|57.82|90.71|||||Ratio (percent) (Test/Reference) of Adjusted Geometric Means||
1722496|NCT00666705|3171566|Superiority or Other||Ratio (percent)|66.77||||||90.0|41.22|108.15|||||Ratio (percent) (Test/Reference) of Adjusted Geometric Means|For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.293) on the natural log scale for Cmax, with 90% coverage probability.|
1722497|NCT00666705|3171567|Superiority or Other||Ratio (percent)|90.33||||||90.0|85.28|95.68|||||Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups.|
1722498|NCT00666705|3171568|Superiority or Other||Ratio (percent)|63.25||||||90.0|44.27|90.39|||||Ratio (percent) (Test/Reference) of Adjusted Geometric Means|For raltegravir, a sample size of 18 subjects provided 90% CIs for the difference between treatments of raltegravir (±0.205) on the natural log scale for AUCτ, with 90% coverage probability.|
1722499|NCT00666705|3171569|Superiority or Other||Ratio (percent)|79.48||||||90.0|67.19|94.02|||||Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 91% power that the 90% CI for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the maximum concentration (Cmax) would lie within the acceptance region of (80%, 125%).|
1722534|NCT00666406|3171631|Superiority or Other||Ratio of the geometric means|1.133|||||2-Sided|90.0|1.01|1.27|||||||
1722500|NCT00666705|3171570|Superiority or Other||Ratio (percent)|85.76||||||90.0|79.89|92.07|||||Ratio (percent) (Test/Reference) of Adjusted Geometric Means|The alternate hypothesis of bioequivalence is that there is no difference between treatment groups. For maraviroc, a sample size of 18 subjects provided 99% power that the 90% confidence interval (CI) for the ratio of Test (raltegravir co-administered with maraviroc) to Reference (maraviroc administered alone) treatment for the area under the plasma concentration-time profile over the dosing interval (AUCτ) would lie within the acceptance region of (80%, 125%).|
1722501|NCT00666679|3171571|Superiority or Other||Difference in Least-Squares Means|0.08||||0.002||95.0|0.03|0.13|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.||
1722502|NCT00666679|3171572|Superiority or Other||Difference in Least-Squares Means|-0.07||||0.013||95.0|-0.12|-0.01|||Mixed Models Analysis|Model with fixed effects for treatment, period and baseline covariate.|Least-Squares Means for change from baseline are derived from mixed model with terms for treatment, period and baseline covariate.||
1722503|NCT00666679|3171573|Superiority or Other||Difference in Least-Squares Means|-5.43|||<=|0||95.0|-8.67|-2.19|||ANCOVA|Model with terms for patient, treatment and period.|Least-Squares Means for percentage of days are derived from ANCOVA model with terms for patient, treatment and period.||
1722504|NCT00666679|3171574|Superiority or Other||Difference in Least-Squares Means|6.08||||0.004||95.0|1.94|10.23|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction and period.|Least-Squares Means for average percentage of days are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction and period.||
1722505|NCT00666679|3171575|Superiority or Other||Difference in Least-Squares Means|-0.6||||0.073||95.0|-1.26|0.06|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.||
1722506|NCT00666679|3171576|Superiority or Other||Difference in Least-Squares Means|-0.09||||0.015||95.0|-0.17|-0.02|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.||
1722507|NCT00666679|3171577|Superiority or Other||Difference in Least-Squares Means|-0.15||||0.005||95.0|-0.26|-0.05|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.||
1722508|NCT00666679|3171578|Superiority or Other||Difference in Least-Squares Means|0.05||||0.033||95.0|0.0|0.09|||Mixed Models Analysis|Model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.|Least-Squares Means for average change from baseline are derived using appropriate contrast from mixed model with fixed effects for treatment, time (weeks 1 and 2), treatment-by-time interaction, period and baseline covariate.||
1722509|NCT00666562|3171600|Superiority or Other|||||||0.046|||||||t-test, 2 sided||||
1722510|NCT00666458|3171607|Superiority or Other||Mean Difference (Net)|0.3|Standard Error of the Mean|0.115|||2-Sided|95.0|0.08|0.53|||||||
1722511|NCT00666458|3171608|Superiority or Other||Mean Difference (Net)|5.42|Standard Error of the Mean|2.064|||2-Sided|95.0|1.37|9.47|||||||
1722512|NCT00666458|3171609|Superiority or Other||Difference in Percent|-2.8|||||2-Sided|95.0|-9.0|3.5|||||||
1722513|NCT00666458|3171610|Superiority or Other||Mean Difference (Net)|0.09|Standard Error of the Mean|0.055|||2-Sided|95.0|-0.01|0.2|||||||
1722514|NCT00666406|3171611|Superiority or Other||Ratio of the geometric means|0.911|||||2-Sided|90.0|0.8|1.039|||||||
1722515|NCT00666406|3171612|Superiority or Other||Ratio of the geometric means|0.984|||||2-Sided|90.0|0.788|1.228|||||||
1722516|NCT00666406|3171613|Superiority or Other||Ratio of the geometric means|0.855|||||2-Sided|90.0|0.73|1.002|||||||
1722517|NCT00666406|3171614|Superiority or Other||Ratio of the geometric means|0.862|||||2-Sided|90.0|0.807|0.92|||||||
1722518|NCT00666406|3171615|Superiority or Other||Ratio of the geometric means|1.059|||||2-Sided|90.0|0.442|2.539|||||||
1722519|NCT00666406|3171616|Superiority or Other||Ratio of the geometric means|0.724|||||2-Sided|90.0|0.304|1.728|||||||
1722520|NCT00666406|3171617|Superiority or Other||Ratio of the geometric means|1.303|||||2-Sided|90.0|0.841|2.02|||||||
1722521|NCT00666406|3171618|Superiority or Other||Ratio of the geometric means|1.0|||||2-Sided|90.0|1.0|1.0|||||||
1722522|NCT00666406|3171619|Superiority or Other||Ratio of the geometric means|0.996|||||2-Sided|90.0|0.894|1.111|||||||
1722523|NCT00666406|3171620|Superiority or Other||Ratio of the geometric means|1.02|||||2-Sided|90.0|0.938|1.109|||||||
1722524|NCT00666406|3171621|Superiority or Other||Ratio of the geometric means|0.971|||||2-Sided|90.0|0.849|1.112|||||||
1722525|NCT00666406|3171622|Superiority or Other||Ratio of the geometric means|1.009|||||2-Sided|90.0|0.964|1.056|||||||
1722526|NCT00666406|3171623|Superiority or Other||Ratio of the geometric means|1.133|||||2-Sided|90.0|1.012|1.27|||||||
1722527|NCT00666406|3171624|Superiority or Other||Ratio of the geometric means|1.183|||||2-Sided|90.0|1.027|1.362|||||||
1722528|NCT00666406|3171625|Superiority or Other||Ratio of the geometric means|1.152|||||2-Sided|90.0|1.038|1.279|||||||
1722529|NCT00666406|3171626|Superiority or Other||Ratio of the geometric means|1.178|||||2-Sided|90.0|1.106|1.254|||||||
1722530|NCT00666406|3171627|Superiority or Other||Ratio of the geometric means|1.015|||||2-Sided|90.0|0.901|1.144|||||||
1722531|NCT00666406|3171628|Superiority or Other||Ratio of the geometric means|1.038|||||2-Sided|90.0|0.926|1.163|||||||
1722532|NCT00666406|3171629|Superiority or Other||Ratio of the geometric means|0.964|||||2-Sided|90.0|0.843|1.102|||||||
1722550|NCT00666276|3171657|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Non-drug therapies. The null hypothesis is there is no difference between with Non-drug therapies and without Non-drug therapies in the incidence rate of ADRs."|
1722551|NCT00666276|3171658|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Concomitant drugs. The null hypothesis is there is no difference between with Concomitant drug and without Concomitant drug in the incidence rate of ADRs."|
1722552|NCT00666276|3171659|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Weight. The null hypothesis is there is no difference between over 40kg and less than 40kg in the incidence rate of ADRs."|
1722553|NCT00666276|3171660|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Route of administration. The null hypothesis is there is no difference between oral, injection and switch in the incidence rate of ADRs."|
1722554|NCT00666276|3171661|Superiority or Other||||||<|0.001|||||||Fisher Exact|||"The risk factor tested was Duration of drug administration. The null hypothesis is there is no difference between over 15 days and less than 15 days in the incidence rate of ADRs."|
1722555|NCT00666276|3171662|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Renal dysfunctions. The null hypothesis is there is no difference between with Renal dysfunction and without Renal dysfunction in the incidence rate of ADRs."|
1722556|NCT00666276|3171663|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Hepatic dysfunctions. The null hypothesis is there is no difference between with Hepatic dysfunction and without Hepatic dysfunction in the incidence rate of ADRs."|
1722557|NCT00666276|3171664|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is there is no difference between over 65 and less than 65 in the incidence rate of ADRs."|
1722558|NCT00666276|3171665|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is there is no difference between males and females in the incidence rate of ADRs."|
1722559|NCT00666263|3171677|Superiority or Other|||||||0.021|||||||McNemar||||
1722560|NCT00666263|3171678|Superiority or Other||||||<|0.001|||||||McNemar||||
1722561|NCT00666263|3171680|Superiority or Other||Difference in Least Squared Means|-216.6||||0.059|2-Sided|95.0|-490.41|57.22|||ANOVA||||
1722562|NCT00666263|3171682|Superiority or Other||Difference in Least Squared Means|-26.11|||<|0.001|2-Sided|95.0|-38.96|-13.26|||ANOVA||||
1722563|NCT00666263|3171684|Superiority or Other||Difference in Least Squared Means|-15.57|||<|0.001|2-Sided|95.0|-24.37|-6.77|||ANOVA||||
1722564|NCT00666263|3171686|Superiority or Other||Difference in Least Squared Means|6.03||||0.002|2-Sided|95.0|2.14|9.92|||ANOVA||||
1722565|NCT00666263|3171690|Superiority or Other||||||<|0.001|||||||McNemar||||
1722566|NCT00666263|3171691|Superiority or Other||Difference in least squared means|32.54|||<|0.001|2-Sided|95.0|14.01|51.06|||ANOVA||||
1722567|NCT00666263|3171693|Superiority or Other||||||<|0.001|||||||McNemar||||
1722568|NCT00666263|3171694|Superiority or Other||Difference in least squared means|35.13||||0.005|2-Sided|95.0|8.81|61.46|||ANOVA|Fixed effects ANOVA with factors for sequence (1 or 2), nested within sequence, period (Cross-Over Period 1 or 2), & treatment (IGIV, 10% or placebo)|||
1722569|NCT00666224|3171696|Superiority or Other||Odds Ratio (OR)|0.41|||<|0.0001|2-Sided|95.0|0.27|0.61||Type of unifocal presentation, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization and center effects as covariates.|Regression, Logistic||||
1722570|NCT00666224|3171699|Superiority or Other||Geometric means ratio|0.87||||0.0013|2-Sided|95.0|0.79|0.95|||ANCOVA|Used log-transformed measurements comparing the adjusted geometric means of T2 volume. Center and baseline T2 volume used as covariates.|||
1722571|NCT00666224|3171700|Superiority or Other||Rate ratio|0.42|||<|0.0001|2-Sided|95.0|0.29|0.61|||Quasi-Likelihood NB* Regression|"*NB = Negative Binomial~Center and baseline number of enhancing lesions as covariates."|||
1722572|NCT00666224|3171701|Superiority or Other||Cox Proportional Hazard|0.55||||0.0005|2-Sided|95.0|0.4|0.77||Type of unifocal presentation at baseline, past corticosteroid treatment (Yes/No) for the initial attack prior to randomization, and center effects as covariates.|Regression, Cox||||
1722573|NCT00665847|3171805|Superiority or Other||Proportion|52.5|Standard Error of the Mean|0.05|||2-Sided|95.0|42.7|62.2|||||The standard error for a proportion was calculated as the square root of the variance divided by the number of patients. The variance for a proportion is equal to p*(1-p), with p being the proportion.||
1722574|NCT00665561|3171845|Superiority||Hazard Ratio (HR)|0.92||||0.6225|2-Sided|95.0|0.66|1.28|||Regression, Cox||||
1722575|NCT00665561|3171846|Superiority||Risk Ratio (RR)|0.92|||||2-Sided|95.0|0.66|1.28||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.|
1722576|NCT00665561|3171847|Superiority||Risk Ratio (RR)|0.94|||||2-Sided|95.0|0.59|1.52||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.|
1722577|NCT00665561|3171848|Superiority||Risk Ratio (RR)|0.62|||||2-Sided|95.0|0.35|1.1||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.|
1722578|NCT00665561|3171849|Superiority||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.66|1.52||||||Non-AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.|
1722579|NCT00665561|3171849|Superiority||Risk Ratio (RR)|0.7|||||2-Sided|95.0|0.32|1.52||||||AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.|
1722580|NCT00665561|3171849|Superiority||Risk Ratio (RR)|0.92|||||2-Sided|95.0|0.64|1.33||||||All malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.|
1722620|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.19||||0.264|2-Sided|95.0|-0.15|0.54|||ANCOVA||Leisure time score: Week 6||
1722581|NCT00665561|3171850|Superiority||Risk Ratio (RR)|0.78|||||2-Sided|95.0|0.61|0.99||||||Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.|
1722582|NCT00665561|3171851|Superiority||Risk Ratio (RR)|0.79|||||2-Sided|95.0|0.57|1.08||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.|
1722583|NCT00665561|3171852|Superiority||Risk Ratio (RR)|0.66|||||2-Sided|95.0|0.18|2.47||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.|
1722584|NCT00665561|3171853|Superiority||Risk Ratio (RR)|1.1|||||2-Sided|95.0|0.25|4.93||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.|
1722585|NCT00665561|3171854|Superiority||Risk Ratio (RR)|1.11|||||2-Sided|95.0|0.7|1.76||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.|
1722586|NCT00665561|3171855|Superiority||Risk Ratio (RR)|0.9|||||2-Sided|95.0|0.51|1.59||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.|
1722587|NCT00665561|3171856|Superiority||Risk Ratio (RR)|0.98|||||2-Sided|95.0|0.44|2.18||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.|
1722588|NCT00665561|3171857|Superiority||Risk Ratio (RR)|1.06|||||2-Sided|95.0|0.71|1.58||||||Non-AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.|
1722589|NCT00665561|3171857|Superiority||Risk Ratio (RR)|0.62|||||2-Sided|95.0|0.29|1.31||||||AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.|
1722590|NCT00665561|3171857|Superiority||Risk Ratio (RR)|0.94|||||2-Sided|95.0|0.66|1.33||||||All Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.|
1722591|NCT00665561|3171858|Superiority||Risk Ratio (RR)|0.83|||||2-Sided|95.0|0.12|5.88||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.|
1722592|NCT00665561|3171859|Superiority||Risk Ratio (RR)|0.53|||||2-Sided|95.0|0.42|0.67||||||Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude risk ratio (RR) and CI.|
1722593|NCT00665431|3171879|Non-Inferiority or Equivalence|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|3.45|||||2-Sided|95.0|-1.41|8.31|||||||
1722594|NCT00665431|3171880|Non-Inferiority or Equivalence|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-2.11|||||2-Sided|95.0|-6.82|2.6|||||||
1722595|NCT00665431|3171881|Non-Inferiority or Equivalence|Non-Inferiority margin (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-1.3|||||2-Sided|95.0|-5.94|3.34|||||||
1722596|NCT00665366|3171882|Superiority or Other||Median Difference (Final Values)|0.0||||0.582||95.0|||||ANCOVA||||
1722597|NCT00665366|3171883|Superiority or Other||Risk Ratio (RR)|1.45|||||2-Sided|95.0|0.57|3.71|||||||
1722598|NCT00665366|3171884|Superiority or Other||Mean Difference (Final Values)|0.01||||0.983|2-Sided|95.0|-0.63|0.64|||ANOVA/ANCOVA model||Week 12 LOCF||
1722599|NCT00665366|3171885|Superiority or Other||Mean Difference (Final Values)|0.28||||0.111|2-Sided|95.0|-0.07|0.63|||ANCOVA||Week 12 (LOCF)||
1722600|NCT00665366|3171885|Superiority or Other||Mean Difference (Final Values)|0.21||||0.197|2-Sided|95.0|-0.11|0.54|||ANCOVA||Week 12||
1722601|NCT00665366|3171885|Superiority or Other||Mean Difference (Net)|0.24|||||2-Sided|95.0|-0.05|0.53|||||Week 6||
1722602|NCT00665366|3171885|Superiority or Other||Mean Difference (Net)|0.06|||||2-Sided|95.0|-0.21|0.32|||||Week 3||
1722603|NCT00665366|3171886|Superiority or Other||Mean Difference (Final Values)|0.61||||0.104|2-Sided|95.0|-0.13|1.34|||ANOVA/ANCOVA model||Week 12 (LOCF)||
1722604|NCT00665366|3171886|Superiority or Other||Mean Difference (Final Values)|0.83||||0.031|2-Sided|95.0|0.08|1.58|||ANOVA/ANCOVA model||Week 12||
1722605|NCT00665366|3171886|Superiority or Other||Mean Difference (Net)|0.68|||||2-Sided|95.0|0.07|1.29|||||Week 6||
1722606|NCT00665366|3171887|Superiority or Other||Risk Ratio (RR)|1.1||||0.211|2-Sided|95.0|0.95|1.27|||RR||Week 12||
1722607|NCT00665366|3171887|Superiority or Other||Risk Ratio (RR)|1.16||||0.08|2-Sided|95.0|0.98|1.36|||RR||Week 9||
1722608|NCT00665366|3171887|Superiority or Other||Risk Ratio (RR)|1.06||||0.573|2-Sided|95.0|0.86|1.3|||RR||Week 6||
1722609|NCT00665366|3171887|Superiority or Other||Risk Ratio (RR)|1.02||||0.909|2-Sided|95.0|0.75|1.39|||Risk ratio (RR)||Week 3||
1722610|NCT00665366|3171888|Superiority or Other||Risk Ratio (RR)|1.07||||0.289|2-Sided|95.0|0.94|1.23|||Risk ratio||||
1722611|NCT00665366|3171888|Superiority or Other||Risk Ratio (RR)|1.17||||0.06|2-Sided|95.0|0.99|1.38|||Risk ratio||Week 9||
1722612|NCT00665366|3171888|Superiority or Other||Risk Ratio (RR)|1.07||||0.54|2-Sided|95.0|0.86|1.32|||Risk ratio||Week 6||
1722613|NCT00665366|3171888|Superiority or Other||Risk Ratio (RR)|1.13||||0.466|2-Sided|95.0|0.81|1.59|||Ration of response||Week 3||
1722614|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.23||||0.18||95.0|-0.11|0.57|||ANCOVA||Financial issues score: Week 12||
1722615|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.26||||0.136|2-Sided|95.0|-0.08|0.6|||ANCOVA||Financial issues score: Week 9||
1722616|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.4||||0.019|2-Sided|95.0|0.07|0.74|||ANCOVA||Financial issues score: Week 6||
1722617|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.29||||0.068|2-Sided|95.0|-0.02|0.61|||ANCOVA||Financial issues score: Week 3||
1722618|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.08||||0.641|2-Sided|95.0|-0.27|0.44|||ANCOVA||Leisure time score: Week 12||
1722619|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.0||||0.988|2-Sided|95.0|-0.35|0.35|||ANCOVA||Leisure time score: Week 9||
1722621|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.22||||0.149|2-Sided|95.0|-0.08|0.52|||ANCOVA||Leisure time score: Week 3||
1722622|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.26||||0.544|2-Sided|95.0|-0.58|1.09|||ANCOVA||Interpersonal relationships score: Week 12||
1722623|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.27||||0.525||95.0|-0.56|1.1|||ANCOVA||Interpersonal relationships score: Week 9||
1722624|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.29||||0.457|2-Sided|95.0|-0.48|1.06|||ANCOVA||Interpersonal relationships score: Week 6||
1722625|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.24||||0.499|2-Sided|95.0|-0.45|0.93|||ANCOVA||Interpersonal relationships score: Week 3||
1722626|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.68||||0.072|2-Sided|95.0|-0.06|1.42|||ANCOVA||Cognitive functioning score: Week 12||
1722627|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.62||||0.09|2-Sided|95.0|-0.1|1.34|||ANCOVA||Cognitive functioning score: Week 9||
1722628|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.66||||0.063|2-Sided|95.0|-0.04|1.35|||ANCOVA||Cognitive functioning score: Week 6||
1722629|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.34||||0.284|2-Sided|95.0|-0.28|0.96|||ANCOVA||Cognitive functioning score: Week 3||
1722630|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.25||||0.546|2-Sided|95.0|-0.56|1.07|||ANCOVA||Occupational functioning score: Week 12||
1722631|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.968|2-Sided|95.0|-0.83|0.79|||ANCOVA||Occupational functioning score: Week 9||
1722632|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.671|2-Sided|95.0|-0.94|0.61|||ANCOVA||Occupational functioning score: Week 6||
1722633|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.311|2-Sided|95.0|-1.01|0.32|||ANCOVA||Occupational functioning score: Week 3||
1722634|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.39||||0.178|2-Sided|95.0|-0.18|0.96|||ANCOVA||Autonomy score: Week 12||
1722635|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.37||||0.198|2-Sided|95.0|-0.19|0.93|||ANCOVA||Autonomy score: Week 9||
1722636|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.34||||0.201|2-Sided|95.0|-0.18|0.85|||ANCOVA||Autonomy score: Week 6||
1722637|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.0||||0.991|2-Sided|95.0|-0.49|0.48|||ANCOVA||Autonomy score: Week 3||
1722638|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|1.88||||0.212|2-Sided|95.0|-1.08|4.84|||ANCOVA||Total score: Week 12||
1722639|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|1.47||||0.315|2-Sided|95.0|-1.4|4.35|||ANCOVA||Total score: Week 9||
1722640|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|1.66||||0.221||95.0|-1.0|4.32|||ANCOVA||Total score: Week 6||
1722641|NCT00665366|3171889|Superiority or Other||Mean Difference (Final Values)|0.68||||0.566|2-Sided|95.0|-1.66|3.03|||ANCOVA||Total score: Week 3||
1722642|NCT00665366|3171890|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.567|2-Sided|95.0|-0.37|0.2|||ANOVA/ANCOVA model|Week 12|||
1722643|NCT00665366|3171891|Superiority or Other||Median Difference (Final Values)|0.17||||0.109|2-Sided|95.0|-0.04|0.38|||ANOVA/ANCOVA model|Week 12|||
1722644|NCT00665366|3171891|Superiority or Other||Mean Difference (Net)|0.16||||0.117|2-Sided|95.0|-0.04|0.35|||ANOVA/ANCOVA model||Week 9||
1722645|NCT00665366|3171891|Superiority or Other||Mean Difference (Net)|0.02||||0.843|2-Sided|95.0|-0.15|0.19|||ANOVA/ANCOVA model||Week 6||
1722646|NCT00665366|3171891|Superiority or Other||Mean Difference (Net)|-0.08||||0.24|2-Sided|95.0|-0.22|0.06|||ANOVA/ANCOVA model||Week 3||
1722647|NCT00665366|3171892|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.044|2-Sided|95.0|-0.59|-0.01|||ANOVA/ANCOVA||Week 12||
1722648|NCT00665366|3171892|Superiority or Other||Mean Difference (Net)|-0.28||||0.053|2-Sided|95.0|-0.56|0.0|||ANOVA/ANCOVA||Week 9||
1722649|NCT00665366|3171892|Superiority or Other||Mean Difference (Net)|-0.1||||0.436|2-Sided|95.0|-0.36|0.16|||ANOVA/ANCOVA||Week 6||
1722650|NCT00665366|3171892|Superiority or Other||Mean Difference (Net)|0.05||||0.669|2-Sided|95.0|-0.16|0.25|||ANOVA/ANCOVA||Week 3||
1722651|NCT00665366|3171893|Superiority or Other||Mean Difference (Final Values)|-2.04||||0.058|2-Sided|95.0|-4.14|0.07|||ANCOVA||||
1722652|NCT00665353|3171897|Superiority or Other||proportion|0.053||||0.42|1-Sided|90.0|0.001|||This is an unadjusted p-value. Statistical significance was defined a priori as 0.10.|Exact test of proportions|||The proportion of subjects responding was compared to a historical null rate of 0.02. The hypothesized response rate was 0.15.|
1722653|NCT00665353|3171900|Superiority or Other||proportion|0.158||||0.29|1-Sided|90.0|0.059|||This is an unadjusted p-value. Statistical significance was defined a priori as 0.10.|Exact test of proportions|||The proportion of subjects responding was compared to a historical null rate of 0.10. The hypothesized response rate was 0.30.|
1722654|NCT00664755|3171909|Superiority||Odds Ratio (OR)|2.77||||0.011|2-Sided|95.0|1.17|6.59|||Regression, Logistic||||
1722655|NCT00664560|3171921|Non-Inferiority or Equivalence|Non-Inferiority (NI) margin 10 mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.47|||||2-Sided|95.0|-5.08|4.14|||||||
1722656|NCT00664560|3171922|Non-Inferiority or Equivalence|10 mm Non-Inferiority (NI) margin between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.09|||||2-Sided|95.0|-4.57|4.38|||||||
1722657|NCT00664560|3171923|Non-Inferiority or Equivalence|Non-Inferiority (NI) margin of 10mm between Arm 1 and Arm 2 (NI design uses confidence intervals, not p-values)|Mean Difference (Final Values)|-0.22|||||2-Sided|95.0|-4.76|4.32|||||||
1722658|NCT00664534|3171926|Superiority or Other|||||||0.4935|||||||Fisher Exact||||
1722659|NCT00664534|3171927|Superiority or Other||Least Squares Mean Difference|-0.09|Standard Error of the Mean|0.4|||2-Sided|95.0|-0.89|0.7|||||Least Squares Mean Difference = Premix Insulin Lispro minus Glargine.||
1722660|NCT00664534|3171929|Superiority or Other|||||||0.7834||||||P-value for Week 48|Wilcoxon (Mann-Whitney)||||
1722663|NCT00664534|3171929|Superiority or Other|||||||0.6615||||||P-value for Baseline|Wilcoxon (Mann-Whitney)||||
1722664|NCT00664534|3171931|Superiority or Other|||||||0.2524||||||P-value is for Week 48 HbA1c <=6.5%|Chi-squared||||
1722665|NCT00664534|3171931|Superiority or Other|||||||0.0643||||||P-value is for Week 48 HbA1c <=7.0%|Chi-squared||||
1722666|NCT00664534|3171931|Superiority or Other|||||||0.6963||||||P-value is for Week 32 HbA1c <=6.5%|Chi-squared||||
1722667|NCT00664534|3171931|Superiority or Other|||||||0.2812||||||P-value is for Week 32 HbA1c <=7.0%|Chi-squared||||
1722668|NCT00664534|3171931|Superiority or Other|||||||0.3281||||||P-value is for Week 16 HbA1c <=6.5%|Chi-squared||||
1722669|NCT00664534|3171931|Superiority or Other|||||||0.2127||||||P-value is for Week 16 HbA1c <=7.0%.|Chi-squared||||
1722670|NCT00664534|3171932|Superiority or Other||Least squares mean difference|-0.08|||||2-Sided|95.0|-0.33|0.18|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 48 weeks||
1722671|NCT00664534|3171932|Superiority or Other||Least squares mean difference|0.04|||||2-Sided|95.0|-0.22|0.29|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 32 weeks||
1722672|NCT00664534|3171932|Superiority or Other||Least squares mean difference|0.05|||||2-Sided|95.0|-0.18|0.29|||||Least squares mean difference = (Premix insulin Lispro - Glargine). 16 weeks||
1722673|NCT00664534|3171934|Non-Inferiority or Equivalence|Noninferiority margin is defined as 0.4%. If the upper 95%CI for difference in LSMeans is below 0.4% then MIX arm will be declared noninferior to GLAR arm|Least squares mean difference|-0.14|||||2-Sided|95.0|-0.42|0.13|||||Least squares mean difference = (Premix insulin Lispro -Glargine)||
1722674|NCT00663923|3171978|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Deviation|0.1|<|0.05|2-Sided|95.0|-0.62|-0.001||two - tailed p value <0.05 were considered statistically significant.|t-test, 2 sided|in this study degrees of freedom is sample size - 1|||
1722675|NCT00663858|3171979|Superiority or Other||Mean Difference (Final Values)|-1.324|Standard Error of the Mean|0.62||0.0333|2-Sided|95.0|-2.542|-0.106|||ANCOVA||||
1722676|NCT00663858|3171979|Superiority or Other||Mean Difference (Final Values)|0.711|Standard Error of the Mean|0.722||0.3253|2-Sided|95.0|-709.0|2.132|||ANCOVA||||
1722677|NCT00663858|3171979|Superiority or Other||Mean Difference (Final Values)|-0.592|Standard Error of the Mean|0.662||0.371|2-Sided|95.0|-1.894|0.709|||ANOVA||||
1722678|NCT00663793|3171984|Non-Inferiority or Equivalence|No power calculation was performed for this pilot study||||||0.05|||||||Wilcoxon (Mann-Whitney)|||Area-under-the-curve for serum estradiol|
1722679|NCT00663793|3171985|Non-Inferiority or Equivalence|No power calculation was performed for this pilot study.|||||<|0.05|||||||Wilcoxon sign-rank||||
1722680|NCT00663793|3171986|Non-Inferiority or Equivalence|A sample size of 8 per group was estimated to confer an 80% power to detect a 40% difference in testosterone AUC with a standard deviation of 20% at an alpha of 0.05|||||<|0.05|||||||Wilcoxon sign-rank||||
1722681|NCT00663260|3172011|Superiority or Other||Mean Difference (Final Values)|-2.16|Standard Error of the Mean|0.4395|||2-Sided|95.0|-3.03|-1.29|||||||
1722682|NCT00663260|3172011|Superiority or Other||Mean Difference (Final Values)|-1.81|Standard Error of the Mean|0.4435|||2-Sided|95.0|-2.68|-0.94|||||||
1722683|NCT00663260|3172012|Superiority or Other||Mean Difference (Final Values)|-9.0|Standard Error of the Mean|8.136|||2-Sided|95.0|-25.0|7.0|||||||
1722684|NCT00663260|3172012|Superiority or Other||Mean Difference (Final Values)|-13.6|Standard Error of the Mean|8.142|||2-Sided|95.0|-29.7|2.4|||||||
1722685|NCT00663260|3172013|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.1457||0.435|2-Sided|95.0|-0.4|0.17||Primary endpoints were tested at alpha=0.027 applying Dunnett’s adjustment|ANCOVA||||
1722686|NCT00663260|3172013|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.1448||0.561|2-Sided|95.0|-0.37|0.2||Primary endpoints were tested at alpha=0.027 applying Dunnett’s adjustment|ANCOVA||||
1722687|NCT00663117|3172065|Superiority or Other|||||||0.048|||||||t-test, 1 sided||||
1722688|NCT00663117|3172066|Superiority or Other|||||||0.008|||||||Fisher Exact|||Percentage of patients having a 5-point decline in the endoscopic inflammation score|
1722689|NCT00663117|3172068|Superiority or Other|||||||0.009||||||The percentage of subjects achieving a 70-point drop in CDAI score in naltrexone treated subjects was the percentage acheiving the same drop in the placebo controls|Fisher Exact|||The proportion of those achieving a response with a 70-point decline in CDAI score was compared between naltrexone and placebo treated subjects using the Fisher’s exact test. Analysis was performed with the intent-to-treat criteria. Clinical significance was accepted if the difference met 95% confidence (p<0.05).|
1722690|NCT00663052|3172069|Superiority or Other|||||||0.1454|||||||ANCOVA|||Comparison of treatment groups at Week 24|
1722691|NCT00663052|3172069|Superiority or Other|||||||0.0807|||||||ANCOVA|||Comparison of treatment groups at Week 12|
1722692|NCT00663052|3172070|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison between treatment groups at Week 24|
1722693|NCT00663052|3172070|Superiority or Other|||||||0.2443|||||||Fisher Exact|||Comparison between treatment groups at Week 12|
1722694|NCT00663052|3172072|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison between treatment groups at Week 24|
1722695|NCT00663052|3172072|Superiority or Other|||||||0.2139|||||||Fisher Exact|||Comparison between treatment groups at Week 12|
1722696|NCT00663052|3172078|Superiority or Other||Difference of Adjusted Mean Change|-0.5||||0.1494|2-Sided|95.0|-1.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24|
1722697|NCT00663052|3172078|Superiority or Other||Difference of Adjusted Mean Change|-0.7||||0.0539|2-Sided|95.0|-1.4|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12|
1722698|NCT00663052|3172079|Superiority or Other||Difference of adjusted mean change|-0.1||||0.8217|2-Sided|95.0|-0.8|0.6|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24|
1722730|NCT00663052|3172087|Superiority or Other||Proportion difference|11.28||||0.0209|2-Sided|95.0|1.26|21.3|||Fisher Exact|||Comparison between treatment groups at Week 24|
1722699|NCT00663052|3172079|Superiority or Other||Difference of adjusted mean change|0.0||||0.9473|2-Sided|95.0|-0.7|0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12|
1722700|NCT00663052|3172080|Superiority or Other||Difference of adjusted mean change|0.05||||0.0275|2-Sided|95.0|0.01|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24|
1722701|NCT00663052|3172080|Superiority or Other||Difference of adjusted mean change|0.04||||0.0435|2-Sided|95.0|0.0|0.09|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12|
1722702|NCT00663052|3172081|Superiority or Other||Difference of adjusted mean change|-1.3||||0.0506|2-Sided|95.0|-2.6|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24|
1722703|NCT00663052|3172081|Superiority or Other||Difference of adjusted mean change|-1.5||||0.0197|2-Sided|95.0|-2.7|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20|
1722704|NCT00663052|3172081|Superiority or Other||Difference of adjusted mean change|-1.9||||0.0015|2-Sided|95.0|-3.1|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16|
1722705|NCT00663052|3172081|Superiority or Other||Difference of adjusted mean change|-2.2||||0.0009|2-Sided|95.0|-3.5|-0.9|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12|
1722706|NCT00663052|3172081|Superiority or Other||Difference of adjusted mean change|-2.0||||0.0025|2-Sided|95.0|-3.3|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8|
1722707|NCT00663052|3172081|Superiority or Other||Difference of adjusted mean change|-1.2||||0.0471|2-Sided|95.0|-2.4|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4|
1722708|NCT00663052|3172081|Superiority or Other||Difference of adjusted mean change|-0.3||||0.5748|2-Sided|95.0|-1.5|0.8|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2|
1722709|NCT00663052|3172082|Superiority or Other||Proportion difference|4.01||||0.3943|2-Sided|95.0|-5.18|13.2|||Fisher Exact|||Comparison between treatment groups at Week 24|
1722710|NCT00663052|3172082|Superiority or Other||Proportion difference|5.6||||0.1761|2-Sided|95.0|-2.59|13.78|||Fisher Exact|||Comparison between treatment groups at Week 20|
1722711|NCT00663052|3172082|Superiority or Other||Proportion difference|4.85||||0.2536|2-Sided|95.0|-3.46|13.15|||Fisher Exact|||Comparison between treatment groups at Week 16|
1722712|NCT00663052|3172082|Superiority or Other||Proportion difference|10.0||||0.0165|2-Sided|95.0|1.47|18.52|||Fisher Exact|||Comparison between treatment groups at Week 12|
1722713|NCT00663052|3172082|Superiority or Other||Proportion difference|10.0||||0.0165|2-Sided|95.0|1.47|18.52|||Fisher Exact|||Comparison between treatment groups at Week 8|
1722714|NCT00663052|3172082|Superiority or Other||Proportion difference|5.49||||0.2326|2-Sided|95.0|-3.68|14.66|||Fisher Exact|||Comparison between treatment groups at Week 4|
1722715|NCT00663052|3172082|Superiority or Other||Proportion difference|6.24||||0.2283|2-Sided|95.0|-4.11|16.58|||Fisher Exact|||Comparison between treatment groups at Week 2|
1722716|NCT00663052|3172083|Superiority or Other||Proportion difference|10.51||||0.0351|2-Sided|95.0|0.27|20.75|||Fisher Exact|||Comparison between treatment groups at Week 24|
1722717|NCT00663052|3172083|Superiority or Other||Proportion difference|9.05||||0.0672|2-Sided|95.0|-1.08|19.18|||Fisher Exact|||Comparison between treatment groups at Week 20|
1722718|NCT00663052|3172083|Superiority or Other||Proportion difference|11.99||||0.0159|2-Sided|95.0|1.78|22.2|||Fisher Exact|||Comparison between treatment groups at Week 16|
1722719|NCT00663052|3172083|Superiority or Other||Proportion difference|14.16||||0.0055|2-Sided|95.0|3.68|24.64|||Fisher Exact|||Comparison between treatment groups at Week 12|
1722720|NCT00663052|3172083|Superiority or Other||Proportion difference|11.86||||0.0251|2-Sided|95.0|0.94|22.78|||Fisher Exact|||Comparison between treatment groups at Week 8|
1722721|NCT00663052|3172083|Superiority or Other||Proportion difference|9.3||||0.1292|2-Sided|95.0|-2.85|21.45|||Fisher Exact|||Comparison between treatment groups at Week 4|
1722722|NCT00663052|3172083|Superiority or Other||Proportion difference|3.25||||0.6255|2-Sided|95.0|-9.39|15.9|||Fisher Exact|||Comparison between treatment groups at Week 2|
1722723|NCT00663052|3172086|Superiority or Other||Proportion difference|7.7||||0.0907|2-Sided|95.0|-1.53|16.93|||Fisher Exact|||Comparison between treatment groups at Week 24|
1722724|NCT00663052|3172086|Superiority or Other||Proportion difference|7.79||||0.063|2-Sided|95.0|-0.68|16.26|||Fisher Exact|||Comparison between treatment groups at Week 20|
1722725|NCT00663052|3172086|Superiority or Other||Proportion difference|7.06||||0.0902|2-Sided|95.0|-1.32|15.43|||Fisher Exact|||Comparison between treatment groups at Week 16|
1722726|NCT00663052|3172086|Superiority or Other||Proportion difference|8.52||||0.0433|2-Sided|95.0|-0.04|17.07|||Fisher Exact|||Comparison between treatment groups at Week 12|
1722727|NCT00663052|3172086|Superiority or Other||Proportion difference|11.2||||0.0289|2-Sided|95.0|0.65|21.74|||Fisher Exact|||Comparison between treatment groups at Week 8|
1722728|NCT00663052|3172086|Superiority or Other||Proportion difference|8.83||||0.1314|2-Sided|95.0|-2.44|20.1|||Fisher Exact|||Comparison between treatment groups at Week 4|
1722729|NCT00663052|3172086|Superiority or Other||Proportion difference|12.1||||0.0461|2-Sided|95.0|-0.24|24.44|||Fisher Exact|||Comparison between treatment groups at Week 2|
1722731|NCT00663052|3172087|Superiority or Other||Proportion difference|12.04||||0.0129|2-Sided|95.0|2.1|21.97|||Fisher Exact|||Comparison between treatment groups at Week 20|
1722732|NCT00663052|3172087|Superiority or Other||Proportion difference|10.53||||0.0325|2-Sided|95.0|0.43|20.64|||Fisher Exact|||Comparison between treatment groups at Week 16|
1722733|NCT00663052|3172087|Superiority or Other||Proportion difference|21.52|||<|0.0001|2-Sided|95.0|11.02|32.03|||Fisher Exact|||Comparison between treatment groups at Week 12|
1722734|NCT00663052|3172087|Superiority or Other||Proportion difference|14.41|||<|0.0178|2-Sided|95.0|2.17|26.64|||Fisher Exact|||Comparison between treatment groups at Week 8|
1722735|NCT00663052|3172087|Superiority or Other||Proportion difference|14.7|||<|0.0202|2-Sided|95.0|2.19|27.2|||Fisher Exact|||Comparison between treatment groups at Week 4|
1722736|NCT00663052|3172087|Superiority or Other||Proportion difference|5.68|||<|0.3525|2-Sided|95.0|-6.05|17.4|||Fisher Exact|||Comparison between treatment groups at Week 2|
1722737|NCT00663052|3172088|Superiority or Other||Difference of adjusted mean change|-0.2||||0.862|2-Sided|95.0|-2.8|2.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.|||
1722738|NCT00663052|3172089|Superiority or Other||Proportion difference|2.5||||0.6168|2-Sided|95.0|-6.87|11.88|||Fisher Exact|||Comparison between treatment groups at Week 24|
1722739|NCT00663052|3172089|Superiority or Other||Proportion difference|3.98||||0.4039|2-Sided|95.0|-5.38|13.35|||Fisher Exact|||Comparison between treatment groups at Week 20|
1722740|NCT00663052|3172089|Superiority or Other||Proportion difference|3.94||||0.4213|2-Sided|95.0|-5.75|13.63|||Fisher Exact|||Comparison between treatment groups at Week 16|
1722741|NCT00663052|3172089|Superiority or Other||Proportion difference|0.42||||1|2-Sided|95.0|-7.7|8.55|||Fisher Exact|||Comparison between treatment groups at Week 12|
1722742|NCT00663052|3172092|Superiority or Other||Difference of adjusted mean change|-0.3||||0.0602|2-Sided|95.0|-0.6|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24|
1722743|NCT00663052|3172092|Superiority or Other||Difference of adjusted mean change|-0.5||||0.0016|2-Sided|95.0|-0.8|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20|
1722744|NCT00663052|3172092|Superiority or Other||Difference of adjusted mean change|-0.6|||<|0.0001|2-Sided|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16|
1722745|NCT00663052|3172092|Superiority or Other||Difference of adjusted mean change|-0.6|||<|0.0001|2-Sided|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12|
1722746|NCT00663052|3172092|Superiority or Other||Difference of adjusted mean change|-0.4|||<|0.0028|2-Sided|95.0|-0.7|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8|
1722747|NCT00663052|3172092|Superiority or Other||Difference of adjusted mean change|-0.4|||<|0.009|2-Sided|95.0|-0.7|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4|
1722748|NCT00663052|3172092|Superiority or Other||Difference of adjusted mean change|0.0|||<|0.8898|2-Sided|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2|
1722749|NCT00663052|3172093|Superiority or Other||Difference of adjusted mean change|0.0||||0.8683|2-Sided|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24|
1722750|NCT00663052|3172093|Superiority or Other||Difference of adjusted mean change|-0.2||||0.0649|2-Sided|95.0|-0.5|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20|
1722751|NCT00663052|3172093|Superiority or Other||Difference of adjusted mean change|-0.2||||-0.2046|2-Sided|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16|
1722752|NCT00663052|3172093|Superiority or Other||Difference of adjusted mean change|-0.1||||0.3684|2-Sided|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12|
1722753|NCT00663052|3172093|Superiority or Other||Difference of adjusted mean change|-0.1||||0.5467|2-Sided|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8|
1722754|NCT00663052|3172093|Superiority or Other||Difference of adjusted mean change|-0.2||||0.2112|2-Sided|95.0|-0.4|0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4|
1722755|NCT00663052|3172093|Superiority or Other||Difference of adjusted mean change|0.0||||0.7757|2-Sided|95.0|-0.2|0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2|
1722756|NCT00663052|3172094|Superiority or Other||Difference of adjusted mean change|-0.2||||0.1799|2-Sided|95.0|-0.5|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24|
1722757|NCT00663052|3172094|Superiority or Other||Difference of adjusted mean change|-0.6||||0.0004|2-Sided|95.0|-0.9|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20|
1722758|NCT00663052|3172094|Superiority or Other||Difference of adjusted mean change|-0.5||||0.004|2-Sided|95.0|-0.8|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16|
1722759|NCT00663052|3172094|Superiority or Other||Difference of adjusted mean change|-0.8|||<|0.0001|2-Sided|95.0|-1.1|-0.5|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12|
1722760|NCT00663052|3172094|Superiority or Other||Difference of adjusted mean change|-0.6|||<|0.0007|2-Sided|95.0|-0.9|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8|
1722761|NCT00663052|3172094|Superiority or Other||Difference of adjusted mean change|-0.4|||<|0.0074|2-Sided|95.0|-0.7|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4|
1722762|NCT00663052|3172094|Superiority or Other||Difference of adjusted mean change|-0.1|||<|0.6396|2-Sided|95.0|-0.3|0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2|
1722763|NCT00663052|3172095|Superiority or Other||Difference of adjusted mean change|-0.4||||0.0009|2-Sided|95.0|-0.6|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24|
1722764|NCT00663052|3172095|Superiority or Other||Difference of adjusted mean change|-0.4||||0.0018|2-Sided|95.0|-0.6|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20|
1722765|NCT00663052|3172095|Superiority or Other||Difference of adjusted mean change|-0.3||||0.0058|2-Sided|95.0|-0.5|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16|
1722766|NCT00663052|3172095|Superiority or Other||Difference of adjusted mean change|-0.5|||<|0.0001|2-Sided|95.0|-0.7|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12|
1722767|NCT00663052|3172095|Superiority or Other||Difference of adjusted mean change|-0.3|||<|0.0006|2-Sided|95.0|-0.5|-0.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8|
1722768|NCT00663052|3172095|Superiority or Other||Difference of adjusted mean change|-0.2|||<|0.0114|2-Sided|95.0|-0.4|-0.1|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4|
1722769|NCT00663052|3172095|Superiority or Other||Difference of adjusted mean change|-0.2|||<|0.0193|2-Sided|95.0|-0.3|0.0|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2|
1722770|NCT00663052|3172096|Superiority or Other|||||||0.0022|||||||Log Rank|||Comparison between treatment groups for PGA Clear/Almost Clear/Mild (0,1,2). Log rank test used to compare groups; CI based on product-limit method.|
1722771|NCT00663052|3172096|Superiority or Other|||||||0.0003|||||||Log Rank|||Comparison between treatment groups for PGA Clear/Almost Clear (0,1). Log rank test used to compare groups; CI based on product-limit method.|
1722772|NCT00663052|3172097|Superiority or Other||Proportion difference|11.37||||0.0133|2-Sided|95.0|1.96|20.78|||Fisher Exact|||Comparison between treatment groups at Week 24|
1722773|NCT00663052|3172097|Superiority or Other||Proportion difference|10.62||||0.0223|2-Sided|95.0|1.11|20.13|||Fisher Exact|||Comparison between treatment groups at Week 20|
1722774|NCT00663052|3172097|Superiority or Other||Proportion difference|13.54||||0.0044|2-Sided|95.0|3.79|23.29|||Fisher Exact|||Comparison between treatment groups at Week 16|
1722775|NCT00663052|3172097|Superiority or Other||Proportion difference|19.38|||<|0.0001|2-Sided|95.0|9.23|29.53|||Fisher Exact|||Comparison between treatment groups at Week 12|
1722776|NCT00663052|3172097|Superiority or Other||Proportion difference|13.81|||<|0.0207|2-Sided|95.0|1.9|25.72|||Fisher Exact|||Comparison between treatment groups at Week 8|
1722777|NCT00663052|3172097|Superiority or Other||Proportion difference|8.66|||<|0.1754|2-Sided|95.0|-3.82|21.14|||Fisher Exact|||Comparison between treatment groups at Week 4|
1722778|NCT00663052|3172097|Superiority or Other||Proportion difference|5.01|||<|0.3956|2-Sided|95.0|-6.01|16.03|||Fisher Exact|||Comparison between treatment groups at Week 2|
1722779|NCT00663052|3172098|Superiority or Other||Proportion difference|19.56||||0.0012|2-Sided|95.0|7.38|31.74|||Fisher Exact|||Comparison between treatment groups at Week 24|
1722780|NCT00663052|3172098|Superiority or Other||Proportion difference|15.05||||0.0139|2-Sided|95.0|2.67|27.43|||Fisher Exact|||Comparison between treatment groups at Week 20|
1722781|NCT00663052|3172098|Superiority or Other||Proportion difference|13.46||||0.0285|2-Sided|95.0|0.94|25.97|||Fisher Exact|||Comparison between treatment groups at Week 16|
1722782|NCT00663052|3172098|Superiority or Other||Proportion difference|22.04||||0.0004|2-Sided|95.0|9.75|34.33|||Fisher Exact|||Comparison between treatment groups at Week 12|
1722783|NCT00663052|3172098|Superiority or Other||Proportion difference|15.59||||0.0037|2-Sided|95.0|4.53|26.65|||Fisher Exact|||Comparison between treatment groups at Week 8|
1722784|NCT00663052|3172098|Superiority or Other||Proportion difference|6.21||||0.1|2-Sided|95.0|-1.56|13.98|||Fisher Exact|||Comparison between treatment groups at Week 4|
1722785|NCT00663052|3172098|Superiority or Other||Proportion difference|-1.45||||0.6223|2-Sided|95.0|-5.07|2.16|||Fisher Exact|||Comparison between treatment groups at Week 2|
1722786|NCT00663052|3172099|Superiority or Other||Proportion difference|8.64||||0.072|2-Sided|95.0|-0.96|18.24|||Fisher Exact|||Comparison between treatment groups at Week 24|
1726662|NCT00594568|3181042|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1722787|NCT00663052|3172099|Superiority or Other||Proportion difference|8.6||||0.0617|2-Sided|95.0|-0.67|17.87|||Fisher Exact|||Comparison between treatment groups at Week 20|
1722788|NCT00663052|3172099|Superiority or Other||Proportion difference|3.29||||0.4415|2-Sided|95.0|-4.95|11.54|||Fisher Exact|||Comparison between treatment groups at Week 16|
1722789|NCT00663052|3172099|Superiority or Other||Proportion difference|6.1||||0.0401|2-Sided|95.0|-0.26|12.47|||Fisher Exact|||Comparison between treatment groups at Week 12|
1722790|NCT00663052|3172099|Superiority or Other||Proportion difference|0.04||||1|2-Sided|95.0|-3.58|3.67|||Fisher Exact|||Comparison between treatment groups at Week 8|
1722791|NCT00663052|3172099|Superiority or Other||Proportion difference|-0.73||||1|2-Sided|95.0|-2.9|1.44|||Fisher Exact|||Comparison between treatment groups at Week 4|
1722792|NCT00663052|3172099|Superiority or Other||Proportion difference|0.0|||||2-Sided|95.0|-0.74|0.74||||||Comparison between treatment groups at Week 2|
1722793|NCT00663052|3172100|Superiority or Other|||||||0.0432|||||||Log Rank|||Comparison of treatment groups for PASI 100. Log rank test used to compare groups; CI based on product-limit method.|
1722794|NCT00663052|3172100|Superiority or Other|||||||0.0053|||||||Log Rank|||Comparison of treatment groups for PASI 90. Log rank test used to compare groups; CI based on product-limit method.|
1722795|NCT00663052|3172100|Superiority or Other||||||<|0.0001|||||||Log Rank|||Comparison of treatment groups for PASI 75. Log rank test used to compare groups; CI based on product-limit method.|
1722796|NCT00663052|3172100|Superiority or Other||||||<|0.0001|||||||Log Rank|||Comparison of treatment groups for PASI 50. Log rank test used to compare groups; CI based on product-limit method.|
1722797|NCT00663052|3172101|Superiority or Other||Difference of adjusted mean change|-2.0||||0.0042|2-Sided|95.0|-3.4|-0.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 24|
1722798|NCT00663052|3172101|Superiority or Other||Difference of adjusted mean change|-2.1||||0.0012|2-Sided|95.0|-3.3|-0.8|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 20|
1722799|NCT00663052|3172101|Superiority or Other||Difference of adjusted mean change|-2.8|||<|0.0001|2-Sided|95.0|-4.0|-1.5|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 16|
1722800|NCT00663052|3172101|Superiority or Other||Difference of adjusted mean change|-3.6|||<|0.0001|2-Sided|95.0|-5.0|-2.2|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 12|
1722801|NCT00663052|3172101|Superiority or Other||Difference of adjusted mean change|-3.0|||<|0.0001|2-Sided|95.0|-4.4|-1.7|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 8|
1722802|NCT00663052|3172101|Superiority or Other||Difference of adjusted mean change|-1.8|||<|0.0031|2-Sided|95.0|-3.0|-0.6|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 4|
1722803|NCT00663052|3172101|Superiority or Other||Difference of adjusted mean change|-1.3|||<|0.0103|2-Sided|95.0|-2.3|-0.3|||ANCOVA|ANCOVA model with treatment group as a factor and baseline measurement as a covariate were used for comparisons between treatment groups.||Comparison between treatment groups at Week 2|
1722804|NCT00663052|3172102|Superiority or Other||Proportion difference|5.53||||0.183|2-Sided|95.0|-2.82|13.87|||Fisher Exact|||Comparison between treatment groups at Week 24|
1722805|NCT00663052|3172102|Superiority or Other||Proportion difference|6.99||||0.0773|2-Sided|95.0|-1.13|15.1|||Fisher Exact|||Comparison between treatment groups at Week 20|
1722806|NCT00663052|3172102|Superiority or Other||Proportion difference|3.14||||0.3115|2-Sided|95.0|-3.24|9.52|||Fisher Exact|||Comparison between treatment groups at Week 16|
1722807|NCT00663052|3172102|Superiority or Other||Proportion difference|1.57||||0.4957|2-Sided|95.0|-3.23|6.37|||Fisher Exact|||Comparison between treatment groups at Week 12|
1722808|NCT00663052|3172102|Superiority or Other||Proportion difference|-1.46||||0.4983|2-Sided|95.0|-4.21|1.29|||Fisher Exact|||Comparison between treatment groups at Week 8|
1722809|NCT00663052|3172102|Superiority or Other||Proportion difference|-0.73||||1|2-Sided|95.0|-2.9|1.44|||Fisher Exact|||Comparison between treatment groups at Week 4|
1722810|NCT00663052|3172102|Superiority or Other||Proportion difference|0.0|||||2-Sided|95.0|-0.74|0.74||||||Comparison between treatment groups at Week 2|
1722811|NCT00663052|3172103|Superiority or Other||Proportion difference|16.78||||0.0064|2-Sided|95.0|4.46|29.1|||Fisher Exact|||Comparison between treatment groups at Week 24|
1722812|NCT00663052|3172103|Superiority or Other||Proportion difference|15.92||||0.0081|2-Sided|95.0|3.8|28.04|||Fisher Exact|||Comparison between treatment groups at Week 20|
1722813|NCT00663052|3172103|Superiority or Other||Proportion difference|17.31||||0.0031|2-Sided|95.0|5.43|29.19|||Fisher Exact|||Comparison between treatment groups at Week 16|
1722814|NCT00663052|3172103|Superiority or Other||Proportion difference|18.37||||0.0002|2-Sided|95.0|8.3|28.45|||Fisher Exact|||Comparison between treatment groups at Week 12|
1722815|NCT00663052|3172103|Superiority or Other||Proportion difference|3.94||||0.2611|2-Sided|95.0|-3.2|11.07|||Fisher Exact|||Comparison between treatment groups at Week 8|
1722816|NCT00663052|3172103|Superiority or Other||Proportion difference|0.02||||1|2-Sided|95.0|-2.77|2.81|||Fisher Exact|||Comparison between treatment groups at Week 4|
1722817|NCT00663052|3172103|Superiority or Other||Proportion difference|0.0|||||2-Sided|95.0|-0.74|0.74||||||Comparison between treatment groups at Week 2|
1722818|NCT00663052|3172104|Superiority or Other||Proportion difference|18.34||||0.0015|2-Sided|95.0|6.8|29.88|||Fisher Exact|||Comparison between treatment groups at Week 24|
1722819|NCT00663052|3172104|Superiority or Other||Proportion difference|19.8||||0.0006|2-Sided|95.0|8.23|31.38|||Fisher Exact|||Comparison between treatment groups at Week 20|
1726663|NCT00594568|3181042|Superiority or Other||||||<|0.166|||||||Mixed Models Analysis||||
1722820|NCT00663052|3172104|Superiority or Other||Proportion difference|21.84||||0.0003|2-Sided|95.0|9.82|33.85|||Fisher Exact|||Comparison between treatment groups at Week 16|
1722821|NCT00663052|3172104|Superiority or Other||Proportion difference|25.18|||<|0.0001|2-Sided|95.0|12.89|37.47|||Fisher Exact|||Comparison between treatment groups at Week 12|
1722822|NCT00663052|3172104|Superiority or Other||Proportion difference|13.44|||<|0.0156|2-Sided|95.0|2.02|24.86|||Fisher Exact|||Comparison between treatment groups at Week 8|
1722823|NCT00663052|3172104|Superiority or Other||Proportion difference|1.64|||<|0.5929|2-Sided|95.0|-4.4|7.67|||Fisher Exact|||Comparison between treatment groups at Week 4|
1722824|NCT00663052|3172104|Superiority or Other||Proportion difference|1.5|||<|0.2435|2-Sided|95.0|-1.31|4.32|||Fisher Exact|||Comparison between treatment groups at Week 2|
1722825|NCT00663052|3172105|Superiority or Other||Proportion difference|11.46||||0.0068|2-Sided|95.0|2.77|20.15|||Fisher Exact|||Comparison between treatment groups at Week 24|
1722826|NCT00663052|3172105|Superiority or Other||Proportion difference|10.75||||0.0087|2-Sided|95.0|2.35|19.16|||Fisher Exact|||Comparison between treatment groups at Week 20|
1722827|NCT00663052|3172105|Superiority or Other||Proportion difference|14.38||||0.001|2-Sided|95.0|5.39|23.37|||Fisher Exact|||Comparison between treatment groups at Week 16|
1722828|NCT00663052|3172105|Superiority or Other||Proportion difference|20.09|||<|0.0001|2-Sided|95.0|9.77|30.4|||Fisher Exact|||Comparison between treatment groups at Week 12|
1722829|NCT00663052|3172105|Superiority or Other||Proportion difference|19.6|||<|0.0011|2-Sided|95.0|7.51|31.7|||Fisher Exact|||Comparison between treatment groups at Week 8|
1722830|NCT00663052|3172105|Superiority or Other||Proportion difference|17.91|||<|0.0013|2-Sided|95.0|6.5|29.32|||Fisher Exact|||Comparison between treatment groups at Week 4|
1722831|NCT00663052|3172105|Superiority or Other||Proportion difference|3.14|||<|0.3605|2-Sided|95.0|-3.88|10.16|||Fisher Exact|||Comparison between treatment groups at Week 2|
1722832|NCT00663052|3172106|Superiority or Other||Proportion difference|18.34||||0.0015|2-Sided|95.0|6.8|29.88|||Fisher Exact||Primary endpoint used 95% CI to compare to prespecified target rates for each treatment arm.|With 125 participants/group, estimation was: 1)approximately 90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 50% in ETN 50 mg QW, assuming true rate is 65% or greater; 2)90% power to reject null hypothesis- PASI 75 response rate at 24 weeks: 60% in 50 mg BIW, assuming true rate is 74% or greater. The 95% CI widths on these are approximately ±8.8%, indicating PASI 75 for ETN 50 mg QW and ETN 50 mg BIW must be at least 58.8% & 68.8%, respectively to reject null hypotheses.|
1722833|NCT00663039|3172107|Superiority|||||||0.404|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition False Alarms between Oxytocin and Placebo arms|
1722834|NCT00663039|3172107|Superiority|||||||0.185|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition Hits between Oxytocin and Placebo arms|
1722835|NCT00663039|3172107|Superiority|||||||0.016|||||||Wilcoxon (Mann-Whitney)|||Comparison the Facial Affect Recognition Total scores between Oxytocin and Placebo arms|
1722836|NCT00663039|3172108|Superiority|||||||0.946|||||||Wilcoxon (Mann-Whitney)|||Comparison of Reading the Mind in the Eyes total scores between Oxytocin and Placebo arms|
1722837|NCT00663039|3172109|Superiority|||||||0.9|||||||Wilcoxon (Mann-Whitney)||||
1722838|NCT00663039|3172110|Superiority|||||||0.451|||||||Wilcoxon (Mann-Whitney)|||Comparison of Brief Assessments of Cognition for Schizophrenia scores between the Oxytocin and Placebo arms.|
1722839|NCT00663039|3172111|Superiority|||||||0.702|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Oxytocin and Placebo arms.|
1722840|NCT00663039|3172111|Superiority|||||||0.47|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms between Oxytocin and Placebo arms.|
1722841|NCT00663039|3172111|Superiority|||||||0.136|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Hits between Oxytocin and Placebo arms.|
1722842|NCT00663039|3172111|Superiority|||||||0.296|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Hits between Oxytocin and Placebo arms.|
1722843|NCT00663039|3172112|Superiority|||||||0.088|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean False Alarms Reaction Time between Oxytocin and Placebo arms|
1722844|NCT00663039|3172112|Superiority|||||||0.514|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean False Alarms Reaction Time between Oxytocin and Placebo arms|
1722845|NCT00663039|3172112|Superiority|||||||0.858|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP First Half Mean Target Reaction Time between Oxytocin and Placebo arms.|
1722846|NCT00663039|3172112|Superiority|||||||0.559|||||||Wilcoxon (Mann-Whitney)|||Comparison of RVIP Practice Mean Target Reaction Time between Oxytocin and Placebo arms.|
1722847|NCT00663039|3172113|Superiority|||||||0.391|||||||Wilcoxon (Mann-Whitney)|||Comparison of the total amount of money offered during the trust game between the Oxytocin and Placebo arms|
1722848|NCT00663039|3172114|Superiority|||||||0.707|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 3 scores between Oxytocin and Placebo Arms|
1722849|NCT00663039|3172114|Superiority|||||||0.28|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 2 scores between Oxytocin and Placebo Arms|
1722850|NCT00663039|3172114|Superiority|||||||0.578|||||||Wilcoxon (Mann-Whitney)|||Comparison of HVLT Trial 1 scores between Oxytocin and Placebo Arms|
1722851|NCT00663039|3172115|Superiority|||||||0.779|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Social Skill scores between Oxytocin and Placebo arms|
1722852|NCT00663039|3172115|Superiority|||||||0.758|||||||Wilcoxon (Mann-Whitney)|||Comparison of Overall Affect Scores between Oxytocin and Placebo Arms|
1722853|NCT00662909|3172149|Superiority or Other||LS Mean Difference|-0.6||||0.001|2-Sided|95.0|-0.96|-0.24||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1722854|NCT00662909|3172149|Superiority or Other||LS Mean Difference|-0.42||||0.022|2-Sided|95.0|-0.77|-0.06||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1722855|NCT00662909|3172150|Superiority or Other||LS Mean Difference|-0.46|||<|0.001|2-Sided|95.0|-0.79|-0.13||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1722856|NCT00662909|3172150|Superiority or Other||LS Mean Difference|-0.48|||<|0.003|2-Sided|95.0|-0.8|-0.15||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1722857|NCT00662909|3172151|Superiority or Other||LS Mean Difference|11.0||||0.002|2-Sided|95.0|4.2|17.7||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1722858|NCT00662909|3172151|Superiority or Other||LS Mean Difference|11.1||||0.001|2-Sided|95.0|4.4|17.9||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1722859|NCT00662909|3172152|Superiority or Other||LS Mean Difference|-0.7|||<|0.001|2-Sided|95.0|-1.07|-0.33||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1722860|NCT00662909|3172152|Superiority or Other||LS Mean Difference|-0.61|||<|0.001|2-Sided|95.0|-0.98|-0.24||LS mean difference and p-value were derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.|ANCOVA|||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. An ANCOVA model was used for hypothesis testing.|
1722861|NCT00662909|3172153|Superiority or Other||LS Mean Difference|-0.5|||<|0.001|2-Sided|95.0|-0.82|-0.18||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1722862|NCT00662909|3172153|Superiority or Other||LS Mean Difference|-0.34|||<|0.026|2-Sided|95.0|-0.66|-0.03||The response variable for the stratified rank ANCOVA was standardized ranks on change from baseline to Final Visit value with baseline standardized ranks and gender as covariates and geographic region as a stratum.|Stratified rank ANCOVA|LS mean difference was derived from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.||Since there were 2 coprimary efficacy endpoints and 3 key secondary efficacy endpoints, the multiplicity among the endpoints was controlled at a type I error rate at the alpha = 0.05 level using a stepwise parallel gatekeeping procedure (5 stages). In addition, since two mirabegron treatment groups were compared with placebo per endpoint, the Hochberg procedure was used to adjust for multiplicity. A stratified rank ANCOVA model was utilized for hypothesis testing.|
1723005|NCT00661141|3172481|Superiority|||||||0.386||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort|
1722863|NCT00662857|3172154|Superiority or Other||Ratio of Geometric Means|0.46|||||2-Sided|90.0|0.366|0.578|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge of TI to 10 U sc insulin lispro.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."||
1722864|NCT00662857|3172155|Superiority or Other||Median Difference (Final Values)|0.0||||0.3531|||||||Signed Rank Test||||
1722865|NCT00662857|3172156|Superiority or Other||Ratio of Geometric Means|0.951|||||2-Sided|90.0|0.823|1.099|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."||
1722866|NCT00662857|3172157|Superiority or Other||Ratio of Geometric Means|0.982|||||2-Sided|90.0|0.846|1.141|||||"Geometric Mean Ratio of serum insulin from a single 30 U cartridge to 2 x 15 U cartridges of TI.~Based on pair-wise comparisons from analysis of covariance fitting the model: natural log of parameter = cohort, treatment, visit, subject (cohort)."||
1722867|NCT00662818|3172175|Superiority or Other||Odds Ratio (OR)|1.35||||0.579|2-Sided|95.0|0.47|3.85|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|||
1722868|NCT00662818|3172176|Superiority or Other||Odds Ratio (OR)|1.83||||0.201|2-Sided|95.0|0.73|4.6|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|||
1722869|NCT00662818|3172177|Superiority or Other||Odds Ratio (OR)|0.8||||0.647|2-Sided|95.0|0.31|2.07|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|||
1722870|NCT00662818|3172178|Superiority or Other||Odds Ratio (OR)|1.22||||0.648|2-Sided|95.0|0.52|2.85|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|||
1722871|NCT00662818|3172182|Superiority or Other||Odds Ratio (OR)|1.44||||0.42|2-Sided|95.0|0.59|3.5|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|||
1722872|NCT00662818|3172183|Superiority or Other||Odds Ratio (OR)|1.62||||0.329|2-Sided|95.0|0.62|4.25|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|||
1722873|NCT00662675|3172185|Superiority or Other||||||<|0.001||||||The p-value is from ANCOVA model with treatment as a factor and baseline percent COA-protein(nitrogen) as a covariate.|ANCOVA||||
1722874|NCT00662675|3172186|Superiority or Other||||||<|0.001|||||||ANCOVA|The p-value is from ANCOVA model with treatment as a factor and baseline percent COA-fat as a covariate.||The power calculation was based on the assumption that the true mean difference between the active and the placebo group was 31.2% with a common standard deviation of 22.6% using a 2-sided, 2-sample, t-test with a 5% significance level.|
1722875|NCT00662558|3172196|Superiority or Other|||||||0.218|||||||Cochran-Mantel-Haenszel|||CMH test adjusted for center was used to compare the two treatment groups.|
1722876|NCT00662558|3172197|Superiority or Other|||||||0.545|||||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.|
1722877|NCT00662558|3172198|Superiority or Other|||||||0.87|||||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.|
1722878|NCT00662558|3172199|Superiority or Other|||||||0.044|||||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 6/ET.|
1722879|NCT00662558|3172199|Superiority or Other|||||||0.786|||||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 3.|
1722880|NCT00662558|3172199|Superiority or Other|||||||0.614|||||||Cochran-Mantel-Haenszel|||P-value reported is the overall p-value for Week 1.|
1722881|NCT00662558|3172200|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.46||0.581||95.0|-0.65|1.16|||ANCOVA||The mean difference reported is the LS mean difference.|Index Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722882|NCT00662558|3172200|Superiority or Other||Mean Difference (Final Values)|0.21|Standard Error of the Mean|1.72||0.902||95.0|-3.16|3.59|||ANCOVA||The mean difference reported is the LS mean difference.|Mental-Interpersonal Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722883|NCT00662558|3172200|Superiority or Other||Mean Difference (Final Values)|0.74|Standard Error of the Mean|1.92||0.7||95.0|-3.03|4.51|||ANCOVA||The mean difference reported is the LS mean difference.|Output Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722884|NCT00662558|3172200|Superiority or Other||Mean Difference (Final Values)|0.48|Standard Error of the Mean|1.88||0.798||95.0|-3.21|4.17|||ANCOVA||The mean difference reported is the LS mean difference.|Physical Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722885|NCT00662558|3172200|Superiority or Other||Mean Difference (Final Values)|2.19|Standard Error of the Mean|1.91||0.252||95.0|-1.56|5.94|||ANCOVA||The mean difference reported is the LS mean difference.|Time Scale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722886|NCT00662558|3172201|Superiority or Other|||||||0.196|||||||Cochran-Mantel-Haenszel|||Optimal sleep was analyzed using CMH general association test.|
1722887|NCT00662558|3172202|Superiority or Other||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|1.14||0.547||95.0|-2.92|1.55|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Problem Index II. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722888|NCT00662558|3172202|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|1.15||0.604||95.0|-2.85|1.66|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Problem Index I. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722889|NCT00662558|3172202|Superiority or Other||Mean Difference (Final Values)|-1.27|Standard Error of the Mean|1.34||0.341||95.0|-3.9|1.35|||ANCOVA||The mean difference reported is the LS mean difference.|Somnolence. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722890|NCT00662558|3172202|Superiority or Other||Mean Difference (Final Values)|-1.51|Standard Error of the Mean|1.69||0.37||95.0|-4.83|1.8|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Adequacy. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722891|NCT00662558|3172202|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.23||0.336||95.0|-0.67|0.23|||ANCOVA||The mean difference reported is the LS mean difference.|Quantity of Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722892|NCT00662558|3172202|Superiority or Other||Mean Difference (Final Values)|-0.87|Standard Error of the Mean|1.45||0.549||95.0|-3.7|1.97|||ANCOVA||The mean difference reported is the LS mean difference.|Awaken Shortness of Breath or Headache. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722893|NCT00662558|3172202|Superiority or Other||Mean Difference (Final Values)|-0.66|Standard Error of the Mean|1.67||0.691||95.0|-3.94|2.61|||ANCOVA||The mean difference reported is the LS mean difference.|Snoring. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722894|NCT00662558|3172202|Superiority or Other||Mean Difference (Final Values)|-1.29|Standard Error of the Mean|1.51||0.392||95.0|-4.26|1.67|||ANCOVA||The mean difference reported is the LS mean difference.|Sleep Disturbance. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722895|NCT00662558|3172203|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.14||0.973||95.0|-0.27|0.28|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interference Subscale. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722896|NCT00662558|3172203|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.16||0.793||95.0|-0.28|0.36|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Enjoyment of Life. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722897|NCT00662558|3172203|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.17||0.992||95.0|-0.32|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Normal Work. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722898|NCT00662558|3172203|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.17||0.739||95.0|-0.38|0.27|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Sleep. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722899|NCT00662558|3172203|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.14||0.806||95.0|-0.25|0.32|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Relations With Others. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722900|NCT00662558|3172203|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.16||0.44||95.0|-0.19|0.43|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Walking Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722901|NCT00662558|3172203|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.16||0.618||95.0|-0.4|0.24|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With Mood. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722902|NCT00662558|3172203|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.16||0.893||95.0|-0.28|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|Pain Interfered With General Activity. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722903|NCT00662558|3172203|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.16||0.492||95.0|-0.41|0.2|||ANCOVA||The mean difference reported is the LS mean difference.|Average Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722904|NCT00662558|3172203|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.17||0.796||95.0|-0.38|0.29|||ANCOVA||The mean difference reported is the LS mean difference.|Worst Pain in Past 24 Hours. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722905|NCT00662558|3172203|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.16||0.741||95.0|-0.36|0.25|||ANCOVA||The mean difference reported is the LS mean difference.|How Much Pain Now. The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722906|NCT00662558|3172204|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.32||0.339||95.0|-0.95|0.33|||ANCOVA||The mean difference reported is the LS mean difference.|The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722907|NCT00662558|3172205|Superiority or Other|||||||0.47|||||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.|
1722908|NCT00662558|3172206|Superiority or Other|||||||0.829|||||||Cochran-Mantel-Haenszel|||CMH tests using row mean score and adjusted for center was used to compare the two treatment groups.|
1722909|NCT00662558|3172207|Superiority or Other||Mean Difference (Final Values)|-0.94|Standard Error of the Mean|1.76||0.595||95.0|-4.39|2.52|||ANCOVA||The mean difference reported is the LS mean difference.|The change from Baseline was compared between the two treatment groups using ANCOVA, with treatment and center as factors, and Baseline value as a covariate.|
1722910|NCT00662558|3172208|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.17||0.234||95.0|-0.53|0.13|||ANCOVA||The mean difference reported is the least squares (LS) mean difference.|The change from Baseline was compared between the two treatment groups using analysis of covariance (ANCOVA), with treatment and center as factors, and Baseline value as a covariate.|
1722911|NCT00662558|3172209|Superiority or Other|||||||0.008|||||||Cochran-Mantel-Haenszel|||If celecoxib 200 mg BID was found to be non-inferior to tramadol hydrochloride 50 mg QID then the second step was to test the superiority of celecoxib 200 mg BID over tramadol hydrochloride 50 mg QID using a two-sided test of proportions. Differences in proportions were tested using the General Association Test of the Cochran-Mantel-Haenszel (CMH) procedure stratified by center.|
1722912|NCT00662558|3172209|Non-Inferiority or Equivalence|Differences in treatment proportions and the 95% confidence interval (CI) around the difference were estimated by calculating the risk difference between the treatment arms using a generalized linear model with treatment and center as factors. A lower 95% CI for the risk difference greater than -0.10 would demonstrate that celecoxib 200 mg BID is not inferior to tramadol hydrochloride 50 mg QID.|Risk Difference (RD)|0.091||||||95.0|0.0255|0.1565|||||||
1722913|NCT00662363|3172220|Superiority or Other||||||<|0.05|||||||independent sample t test|||Primary outcome measures chosen were between group comparisons for change on Constipation Symptom Questionnaire ratings at exit from the study. The PAC-SYM is a symptom scale where higher numbers indicate more symptoms. Change from baseline to Day 7 was calculated and larger negative differences indicated greater improvement in constipation symptoms. The PAC-QOL is a quality of life scale where higher numbers indicate better quality of life. Change from baseline to 7 days was calculated.|
1722914|NCT00662129|3172245|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1722915|NCT00662025|3172266|Superiority or Other||CBR Rate (percentage)|52.4|||||2-Sided|95.0|39.4|65.1|||||||
1722916|NCT00662025|3172267|Superiority or Other||CBR Rate (percentage)|50.8|||||2-Sided|95.0|37.9|63.6|||||||
1722917|NCT00662025|3172268|Superiority or Other||Objective Response Rate (percentage)|27.0|||||2-Sided|95.0|16.6|39.7|||||||
1722918|NCT00662025|3172269|Superiority or Other||Objective Response Rate (percentage)|30.2|||||2-Sided|95.0|19.2|43.0|||||||
1722919|NCT00661999|3172272|Superiority or Other|||||||0.2025||||||Test comparison for week 16 level.|Kruskal-Wallis||||
1722920|NCT00661999|3172272|Superiority or Other|||||||0.0424||||||Test comparison for week 7 level.|Kruskal-Wallis||||
1722921|NCT00661999|3172272|Superiority or Other|||||||0.1139||||||Test comparison for baseline level.|Kruskal-Wallis||||
1722922|NCT00661999|3172273|Superiority or Other|||||||0.2016||||||Test comparison for week 16 level.|Kruskal-Wallis||||
1722923|NCT00661999|3172273|Superiority or Other|||||||0.8042||||||Test comparison for week 7 level.|Kruskal-Wallis||||
1722924|NCT00661999|3172273|Superiority or Other|||||||0.1137||||||Test comparison for baseline level.|Kruskal-Wallis||||
1722925|NCT00661999|3172274|Superiority or Other|||||||0.0022||||||Test Comparison for Week 16 Level.|Kruskal-Wallis||||
1722926|NCT00661999|3172274|Superiority or Other|||||||0.0002||||||Test Comparison for Week 7 Level.|Kruskal-Wallis||||
1722927|NCT00661999|3172274|Superiority or Other|||||||0.9022||||||Test comparison for Baseline level.|Kruskal-Wallis||||
1722928|NCT00661999|3172275|Superiority or Other|||||||0.3358||||||Test Comparison for week 16 level|Kruskal-Wallis||||
1722929|NCT00661999|3172275|Superiority or Other|||||||0.0113||||||Test comparison for week 7 level|Kruskal-Wallis||||
1722930|NCT00661999|3172275|Superiority or Other|||||||0.1826||||||Test Comparison for Week 1 Level.|Kruskal-Wallis||||
1722931|NCT00661999|3172276|Superiority or Other|||||||0.322||||||Test Comparison for Week 16 Level|Kruskal-Wallis||||
1722932|NCT00661999|3172276|Superiority or Other|||||||0.0663||||||Test Comparison for Week 7 Level.|Kruskal-Wallis||||
1722933|NCT00661999|3172276|Superiority or Other|||||||0.3852||||||Test Comparison for Week 1 Level|Kruskal-Wallis||||
1722934|NCT00661999|3172277|Superiority or Other|||||||0.83|||||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.|
1722935|NCT00661999|3172277|Superiority or Other|||||||0.73|||||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.|
1722936|NCT00661999|3172278|Superiority or Other|||||||0.17|||||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.|
1722937|NCT00661999|3172278|Superiority or Other|||||||0.19|||||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.|
1722962|NCT00661726|3172309|Superiority or Other|||||||0.045|||||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.|
1722938|NCT00661999|3172279|Superiority or Other|||||||0.3|||||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.|
1722939|NCT00661999|3172279|Superiority or Other|||||||0.62|||||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.|
1722940|NCT00661999|3172280|Superiority or Other|||||||0.44|||||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.|
1722941|NCT00661999|3172280|Superiority or Other|||||||0.61|||||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.|
1722942|NCT00661999|3172282|Superiority or Other|||||||0.0648|||||||Log Rank||||
1722943|NCT00661999|3172283|Superiority or Other|||||||0.2051|||||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.|
1722944|NCT00661999|3172283|Superiority or Other|||||||0.1124|||||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.|
1722945|NCT00661999|3172284|Superiority or Other|||||||0.566|||||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.|
1722946|NCT00661999|3172284|Superiority or Other|||||||0.6639|||||||t-test, 2 sided|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 33% of the standard deviation in average hemoglobin levels through two-sided alternative, with a 2.5% type I error rate.|
1722947|NCT00661999|3172285|Superiority or Other|||||||0.87|||||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate.|
1722948|NCT00661999|3172285|Superiority or Other|||||||0.725|||||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 15% in the true percentage of patients that need transfusion was at least 30% in the superior group, with a 2.5% type I error rate.|
1722949|NCT00661999|3172287|Superiority or Other|||||||0.73|||||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.|
1722950|NCT00661999|3172287|Superiority or Other|||||||0.39|||||||Fisher Exact|||With 176 evaluable participants per treatment arm, there would have been >=80% power to detect a difference across two treatment arms of 15% in the primary hematopoietic response endpoint through Fisher's exact test, if the true percentage of patients that experience a hematopoietic response was at least 30% in the superior group, with a 2.5% type I error rate.|
1722951|NCT00661830|3172293|Superiority or Other||Hazard Ratio (HR)|1.2|||||2-Sided|95.0|0.747|1.927|||||||
1722952|NCT00661830|3172294|Superiority or Other||Hazard Ratio (HR)|1.281|||||2-Sided|95.0|0.811|2.023|||||||
1722953|NCT00661726|3172300|Superiority or Other||||||<|0.01|||||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.|
1722954|NCT00661726|3172301|Superiority or Other|||||||0.11|||||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.|
1722955|NCT00661726|3172302|Superiority or Other|||||||0.022|||||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.|
1722956|NCT00661726|3172303|Superiority or Other|||||||0.18|||||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.|
1722957|NCT00661726|3172304|Superiority or Other|||||||0.069|||||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.|
1722958|NCT00661726|3172305|Superiority or Other||||||<|0.01|||||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.|
1722959|NCT00661726|3172306|Superiority or Other|||||||0.18|||||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.|
1722960|NCT00661726|3172307|Superiority or Other|||||||0.039|||||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.|
1722961|NCT00661726|3172308|Superiority or Other|||||||0.083|||||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.|
1722963|NCT00661726|3172311|Superiority or Other||||||<|0.01|||||||Regression, Linear|||Linear regression after adjusting for time duration was used to test the mean difference between baseline and follow-up values.|
1722964|NCT00661674|3172326|Superiority or Other|||||||0.2244||||||p-value represents comparison between SOWS scores at T=180 and the baseline measurements at T=-30.|Friedman Test|||"Null Hypothesis: There will be no difference in SOWS scores when comparing the 2 treatment groups (Palonosetron & Palonosetron + Hydroxyzine) with placebo.~Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals."|
1722965|NCT00661674|3172327|Superiority or Other|||||||0.0001||||||p-value represents comparison between OOWS scores at T=180 and the baseline measurements at T=-30.|Friedman Test|||"Null Hypothesis: There will be no difference in OOWS scores when comparing treatment groups (Palonosetron & Palonosetron + Hydroxyzine) with placebo.~Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals."|
1722966|NCT00661362|3172443|Superiority or Other||Mean Difference (Net)|16.1|||<|0.0001|2-Sided|95.0|8.0|24.0|||ANCOVA||||
1722967|NCT00661362|3172444|Superiority or Other||Mean Difference (Net)|-2802.0|Standard Error of the Mean|989.8||0.0052|2-Sided|95.0|-4753.0|-852.0|||ANCOVA||||
1722968|NCT00661362|3172445|Superiority or Other||Mean Difference (Net)|-155.0|Standard Error of the Mean|55.0||0.0052|2-Sided|95.0|-264.0|-47.0|||ANCOVA||||
1722969|NCT00661362|3172446|Superiority or Other||Mean Difference (Net)|-10.1|Standard Error of the Mean|2.684|<|0.0002|2-Sided|95.0|-15.37|-4.83|||ANCOVA||||
1722970|NCT00661362|3172447|Superiority or Other||Mean Difference (Net)|-0.56|Standard Error of the Mean|0.149|<|0.0002|2-Sided|95.0|-0.85|-0.26|||ANCOVA||||
1722971|NCT00661362|3172448|Superiority or Other||Mean Difference (Net)|-0.42|Standard Error of the Mean|0.067|<|0.0001|2-Sided|95.0|-0.55|-0.29|||ANCOVA||||
1722972|NCT00661141|3172458|Superiority||ratio of parameter means|97.9|||||2-Sided|90.0|84.84|112.97|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.|
1722973|NCT00661141|3172458|Superiority||ratio of parameter means|107.05|||||2-Sided|90.0|87.42|131.1|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.|
1722974|NCT00661141|3172458|Superiority||ratio of parameter means|94.15|||||2-Sided|90.0|78.01|1113.63|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722975|NCT00661141|3172460|Superiority||ratio of parameter means|94.7|||||2-Sided|90.0|82.7|108.42|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.|
1722976|NCT00661141|3172460|Superiority||ratio of parameter means|100.41|||||2-Sided|90.0|77.86|129.49|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.|
1722977|NCT00661141|3172460|Superiority||ratio of parameter means|104.12|||||2-Sided|90.0|83.5|129.84|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722978|NCT00661141|3172460|Superiority||ratio of parameter means|106.08|||||2-Sided|90.0|96.81|116.24|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722979|NCT00661141|3172460|Superiority||ratio of parameter means|112.28|||||2-Sided|90.0|103.72|121.54|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722980|NCT00661141|3172460|Superiority||ratio of parameter means|90.2|||||2-Sided|90.0|69.54|117.0|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722981|NCT00661141|3172463|Superiority||ratio of parameter means|86.04|||||2-Sided|90.0|55.78|132.73|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.|
1722982|NCT00661141|3172463|Superiority||ratio of parameter means|70.77|||||2-Sided|90.0|34.16|146.59|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.|
1722983|NCT00661141|3172463|Superiority||ratio of parameter means|88.6|||||2-Sided|90.0|56.66|138.54|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722984|NCT00661141|3172463|Superiority||ratio of parameter means|105.31|||||2-Sided|90.0|89.24|124.27|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722985|NCT00661141|3172463|Superiority||ratio of parameter means|124.46|||||2-Sided|90.0|88.77|174.5|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722986|NCT00661141|3172463|Superiority||ratio of parameter means|69.13|||||2-Sided|90.0|48.88|97.78|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722987|NCT00661141|3172469|Superiority||ratio of parameter means|122.83|||||2-Sided|90.0|82.45|183.0|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analysis for Cohort 3 where all available data were included.|
1722988|NCT00661141|3172469|Superiority||ratio of parameter means|150.33|||||2-Sided|90.0|93.14|242.63|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722989|NCT00661141|3172469|Superiority||ratio of parameter means|123.7|||||2-Sided|90.0|93.55|163.56|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722990|NCT00661141|3172469|Superiority||ratio of parameter means|121.81|||||2-Sided|90.0|108.42|136.84|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722991|NCT00661141|3172471|Superiority||ratio of parameter means|137.17|||||2-Sided|90.0|123.3|152.59|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.|
1722992|NCT00661141|3172471|Superiority||ratio of parameter means|123.17|||||2-Sided|90.0|108.61|139.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.|
1722993|NCT00661141|3172471|Superiority||ratio of parameter means|103.13|||||2-Sided|90.0|84.35|126.1|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722994|NCT00661141|3172471|Superiority||ratio of parameter means|143.39|||||2-Sided|90.0|107.72|190.87|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722995|NCT00661141|3172471|Superiority||ratio of parameter means|120.76|||||2-Sided|90.0|108.8|134.03|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722996|NCT00661141|3172471|Superiority||ratio of parameter means|139.63|||||2-Sided|90.0|92.18|211.51|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1722997|NCT00661141|3172474|Superiority||ratio of parameter means|112.64|||||2-Sided|90.0|96.14|131.98|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|Analyses for Cohort 3 where all available data were included.|
1722998|NCT00661141|3172474|Superiority||ratio of parameter means|115.25|||||2-Sided|90.0|91.19|145.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.|3 participants in Cohort 3 had some residual 4-MP detected on Day 2 (Placebo treatment). As a result, the data for the participants on Day 2 were excluded from these statistical analyses, which could be compared with the analyses below where all available data were included.|
1722999|NCT00661141|3172474|Superiority||ratio of parameter means|82.4|||||2-Sided|90.0|62.83|108.07|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1723000|NCT00661141|3172474|Superiority||ratio of parameter means|137.58|||||2-Sided|90.0|115.66|163.65|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1723001|NCT00661141|3172474|Superiority||ratio of parameter means|126.05|||||2-Sided|90.0|101.94|155.87|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1723002|NCT00661141|3172474|Superiority||ratio of parameter means|115.57|||||2-Sided|90.0|90.45|147.67|||||Ratio of parameter means (Antizol/placebo, expressed as a percent), transformed back to the linear scale. 90% confidence interval for ratio of parameter means (expressed as a percent), transformed back to the linear scale.||
1723003|NCT00661141|3172481|Superiority|||||||0.0154||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||3.0 mg/kg, 5.0 mg/kg|
1723004|NCT00661141|3172481|Superiority|||||||0.0006||||||P-values for pairwise comparison between cohorts from ANOVA|ANOVA|||1.0 mg/kg, 5.0 mg/kg|
1726664|NCT00594568|3181043|Superiority or Other|||||||0.746|||||||Mixed Models Analysis||||
1723006|NCT00661141|3172481|Superiority|||||||0.0023||||||Overall p-value testing cohort difference from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort, 5.0 mg/kg cohort|
1723007|NCT00661141|3172484|Superiority|||||||0.8727||||||Overall p-value testing cohort difference from ANOVA|ANOVA|||1.0 mg/kg Cohort, 3.0 mg/kg cohort, 5.0 mg/kg cohort|
1723008|NCT00660907|3172503|Superiority or Other||Risk Difference (RD)|30.8|Standard Error of the Mean|2.48|<|0.0001|2-Sided|95.0|26.0|35.7||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(reference) = 0 versus the alternative HA: proportion(treat) minus proportion(reference) =/= 0|
1723009|NCT00660907|3172504|Superiority or Other||Risk Difference (RD)|-37.2|Standard Error of the Mean|2.578|<|0.0001|2-Sided|95.0|-42.3|-32.2||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|Regression, Logistic|Based on methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline value.||H0: proportion(treat) minus proportion(reference) = 0 versus the alternative HA: proportion(treat) minus proportion(reference) =/= 0|
1723010|NCT00660907|3172505|Superiority or Other||Mean Difference (Final Values)|-4.65|Standard Error of the Mean|0.2483|<|0.0001|2-Sided|95.0|-5.14|-4.17||Significant at alpha=0.05 (2-sided). Key secondary endpoints are tested following a hierarchical closed testing procedure|ANCOVA|with treatment group as effect and baseline value as covariate||H0: mean(treat) minus mean(reference) = 0 versus the alternative HA: mean(treat) minus mean(reference) =/= 0|
1723011|NCT00660907|3172506|Non-Inferiority or Equivalence|non-inferior margin delta = 0.35|Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.0569|<|0.0001|2-Sided|95.0|-0.11|0.11||Significant at alpha=0.025 (1-sided). A hierarchical closed testing procedure was used to control Type I error across the primary & key secondary objectives|ANCOVA|with treatment group as effect and baseline value as covariate||The null hypothesis is given as H0: mean(treat) minus mean(reference) >= delta versus the alternative HA: mean(treat) minus mean(reference) < delta (with alpha = 0.025, one-sided)|
1723012|NCT00660829|3172508|Superiority or Other|||||||0.001|||||||ANCOVA|||Change from baseline|
1723013|NCT00660829|3172509|Superiority or Other||Mean Difference (Final Values)|-1.2907|Standard Deviation|0.3204|<|0.001||95.0|-1.92|0.66|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.||Change in baseline|
1723014|NCT00660829|3172510|Superiority or Other||Mean Difference (Final Values)|-1.4403|Standard Deviation|0.3406|<|0.001||95.0|-2.11|-0.77|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.|||
1723015|NCT00660829|3172511|Superiority or Other||Mean Difference (Final Values)|-0.7444|Standard Error of the Mean|0.1677|<|0.001||95.0|-1.07|-0.42|||ANOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.|||
1723016|NCT00660829|3172512|Superiority or Other||Mean Difference (Final Values)|-1.5633|Standard Deviation|0.3345|<|0.001||95.0|-2.22|-0.91|||ANCOVA|ANCOVA is being used due to a covariate being included in the model. The covariate is baseline TNSS score.|||
1723017|NCT00660790|3172517|Other||||||<|0.05|||||||t-test, 2 sided|||The paired student’s t-test or the Wilcoxon signed-rank test was used to compare the measurements before and after multifactorial treatment, as appropriate, depending on the distribution of the data.|
1723018|NCT00660543|3172581|Superiority or Other|||||||0.008|||||||t-test, 1 sided|Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.|||
1723019|NCT00660543|3172581|Superiority or Other|||||||0.003|||||||t-test, 1 sided|Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.|||
1723020|NCT00660387|3172595|Superiority or Other||Treatment Difference (LS Mean)|11.4|Standard Error of the Mean|3.7||0.0033|2-Sided|95.0|4.0|18.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723021|NCT00660387|3172596|Superiority or Other||Treatment Difference (LS Mean)|-1.5|Standard Error of the Mean|2.9||0.6088|2-Sided|95.0|-7.4|4.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723022|NCT00660387|3172597|Superiority or Other||Treatment Difference (LS Mean)|-0.4|Standard Error of the Mean|0.4||0.3578|2-Sided|95.0|-1.1|0.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723023|NCT00660387|3172598|Superiority or Other||Treatment Difference (LS Mean)|-1.2|Standard Error of the Mean|0.6||0.0361|2-Sided|95.0|-2.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723024|NCT00660387|3172599|Superiority or Other||Treatment Difference (LS Mean)|0.3|Standard Error of the Mean|0.3||0.3741|2-Sided|95.0|-0.4|0.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723025|NCT00660387|3172600|Superiority or Other||Treatment Difference (LS Mean)|-3.3|Standard Error of the Mean|5.1||0.5213|2-Sided|95.0|-13.6|6.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723026|NCT00660387|3172601|Superiority or Other||Treatment Difference (LS Mean)|-13.8|Standard Error of the Mean|3.5||0.0002|2-Sided|95.0|-20.8|-6.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723027|NCT00660387|3172602|Superiority or Other||Treatment Difference (LS Mean)|-4.0|Standard Error of the Mean|3.4||0.2407|2-Sided|95.0|-10.8|2.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723028|NCT00660387|3172603|Superiority or Other||Treatment Difference (LS Mean)|-3.8|Standard Error of the Mean|3.1||0.2243|2-Sided|95.0|-9.9|2.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723052|NCT00659984|3172667|Superiority or Other||Hazard Ratio (HR)|5.2||||0.363|2-Sided|95.0|-3.4|13.9|||Cochran Armitage Trend Test||||
1723029|NCT00660387|3172604|Superiority or Other||Treatment Difference (LS Mean)|-4.5|Standard Error of the Mean|3.8||0.2423|2-Sided|95.0|-12.0|3.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723030|NCT00660387|3172605|Superiority or Other||Treatment Difference (LS Mean)|-2.2|Standard Error of the Mean|3.4||0.5246|2-Sided|95.0|-9.0|4.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723031|NCT00660387|3172606|Superiority or Other||Treatment Difference (LS Mean)|-11.6|Standard Error of the Mean|4.5||0.0129|2-Sided|95.0|-20.6|-2.5|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723032|NCT00660387|3172607|Superiority or Other||Treatment Difference (LS Mean)|-10.4|Standard Error of the Mean|4.3||0.0184|2-Sided|95.0|-19.1|-1.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723033|NCT00660387|3172608|Superiority or Other||Treatment Difference (LS Mean)|-0.08|Standard Error of the Mean|0.45||0.8574|2-Sided|95.0|-0.98|0.82|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1723034|NCT00660387|3172609|Superiority or Other||Treatment Difference (LS Mean)|-4.5|Standard Error of the Mean|3.1||0.1501|2-Sided|95.0|-10.7|1.7|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1723035|NCT00660387|3172610|Superiority or Other||Treatment Difference (LS Mean)|0.07|Standard Error of the Mean|0.038||0.067|2-Sided|95.0|-0.005|0.146|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding Baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1723036|NCT00660387|3172611|Superiority or Other||Treatment Difference (LS Mean)|1.4|Standard Error of the Mean|2.1||0.502|2-Sided|95.0|-2.8|5.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1723037|NCT00660387|3172612|Superiority or Other||Treatment Difference (LS Mean)|-3.0|Standard Error of the Mean|1.1||0.0086|2-Sided|95.0|-5.3|-0.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1723038|NCT00660387|3172613|Superiority or Other||Treatment Difference (LS Mean)|-0.7|Standard Error of the Mean|0.3||0.0258|2-Sided|95.0|-1.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the baseline CGI-S as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1723039|NCT00660387|3172614|Superiority or Other||Treatment Difference (LS Mean)|-7.0|Standard Error of the Mean|2.8||0.0155|2-Sided|95.0|-12.6|-1.4||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the CGI-Severity (CGI-S, see Baseline Characteristics module) as a covariate.|ANCOVA|||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1723040|NCT00660387|3172615|Superiority or Other||Treatment Difference (LS Mean)|1.86|Standard Error of the Mean|0.65||0.0059|2-Sided|95.0|0.56|3.17|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1723041|NCT00660387|3172616|Superiority or Other||Treatment Difference (LS Mean)|-1.91|Standard Error of the Mean|0.57||0.0015|2-Sided|95.0|-3.05|-0.76||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline and the natural logarithm of the mean daily dose of rescue medication on valid symptom diary days as covariates.|ANCOVA||||
1723042|NCT00660192|3172635|Superiority or Other|||||||0.03|||||||Fisher Exact||||
1723043|NCT00660192|3172636|Superiority or Other|||||||0.0347|||||||t-test, 2 sided||||
1723044|NCT00660179|3172642|Superiority or Other||Hazard Ratio (HR)|0.771||||0.2509|2-Sided|97.5|0.464|1.282|||Log Rank||||
1723045|NCT00660179|3172642|Superiority or Other||Hazard Ratio (HR)|1.046||||0.8312|2-Sided|97.5|0.653|1.673|||Log Rank||||
1723046|NCT00660179|3172643|Superiority or Other||Hazard Ratio (HR)|0.638||||0.2037|2-Sided|97.5|0.287|1.418|||Log Rank||||
1723047|NCT00660179|3172643|Superiority or Other||Hazard Ratio (HR)|0.971||||0.9249|2-Sided|97.5|0.477|1.976|||Log Rank||||
1723048|NCT00660179|3172644|Superiority or Other||Hazard Ratio (HR)|0.5|||<|0.0001|2-Sided|97.5|0.335|0.747|||Log Rank||||
1723049|NCT00660179|3172644|Superiority or Other||Hazard Ratio (HR)|0.669|||<|0.0146|2-Sided|97.5|0.462|0.97|||Log Rank||||
1723050|NCT00660179|3172645|Superiority or Other||Hazard Ratio (HR)|0.547|||<|0.0001|2-Sided|97.5|0.392|0.762|||Log Rank||||
1723051|NCT00660179|3172645|Superiority or Other||Hazard Ratio (HR)|0.704|||<|0.0108|2-Sided|97.5|0.516|0.96|||Log Rank||||
1723053|NCT00659945|3172673|Superiority or Other||||||<|0.05|||||||Chi-squared|||The primary endpoint was the incidence of emesis at any time within the first 48 hours after surgery. Power analysis showed that a sample size of 69 patients per group was necessary to detect a significant decrease in the incidence of emesis from 33% in the placebo group to 15% in the aprepitant group using a Chi-square test with an alpha value of 0.05 and power of 80%.|
1723054|NCT00659880|3172675|Superiority or Other|||||||0.06|||||||Friedman||||
1723055|NCT00659607|3172695|Superiority or Other|||||||0.0245|||||||Chi-squared||||
1723056|NCT00659607|3172696|Superiority or Other|||||||0.0393|||||||Chi-squared||||
1723057|NCT00659607|3172697|Superiority or Other|||||||0.0007|||||||Chi-squared||||
1723058|NCT00659607|3172698|Superiority or Other|||||||0.0075|||||||Chi-squared||||
1723059|NCT00659607|3172699|Superiority or Other||Odds Ratio (OR)|3.3|||<|0.0001|2-Sided|95.0|1.642|6.776|||Chi-squared||The Estimation of Odds Ratio and 95% Confidence Interval based the logistic regression analysis||
1723060|NCT00659607|3172700|Superiority or Other||Odds Ratio (OR)|2.2||||0.0003|2-Sided|95.0|1.121|4.151|||Chi-squared||The estimation of Odds Ratio and 95% Confidence Interval based on the logistic regression analysis||
1723061|NCT00659607|3172702|Superiority or Other||||||<|0.0001|||||||t-test for paired observations||||
1723062|NCT00659607|3172703|Superiority or Other|||||||0.8249|||||||Fisher Exact||||
1723063|NCT00659607|3172704|Superiority or Other|||||||0.9207|||||||Chi-squared||||
1723064|NCT00659607|3172705|Superiority or Other|||||||0.9674|||||||Chi-squared||||
1723065|NCT00659607|3172706|Superiority or Other|||||||0.2669|||||||Chi-squared||||
1723066|NCT00659607|3172707|Superiority or Other||||||<|0.0001|||||||t-test for paired observations||||
1723067|NCT00659373|3172777|Superiority or Other|||||||0.71|||||||Wilcoxon (Mann-Whitney)||||
1723068|NCT00659269|3172789|Superiority or Other|||||||0.91|||||||ANOVA||||
1723069|NCT00659230|3172793|Superiority||Effect Size|0.11||||0.396|2-Sided|90.0|-0.35|0.56|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.||
1723070|NCT00659230|3172794|Superiority||Effect size|-0.18||||0.951|2-Sided|90.0|-0.64|0.27|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.||
1723071|NCT00659230|3172795|Superiority||Effect Size|-0.07||||0.54|2-Sided|90.0|-0.52|0.39|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.||
1723072|NCT00659230|3172796|Superiority or Other||Effect Size|-0.18||||0.723|2-Sided|90.0|-0.64|0.27|||ANOVA||Effect size (ES) for change in CAPS-D score relative to baseline was calculated according to the method of Cohen.|The analysis was conducted using a repeated-measures analysis of variance (ANOVA) model. The model consisted of two factors – treatment at two levels and time (5 time points including baseline) and group by time interaction.|
1723073|NCT00659061|3172798|Superiority or Other|||||||0.49||||||endline|Chi-squared||||
1723074|NCT00659061|3172798|Superiority or Other|||||||0.93||||||baseline|Chi-squared||||
1723075|NCT00659061|3172799|Superiority or Other|||||||0.89||||||endline|Chi-squared||||
1723076|NCT00659061|3172799|Superiority or Other|||||||0.62||||||baseline|Chi-squared||||
1723077|NCT00659061|3172800|Superiority or Other|||||||0.02||||||endline|Chi-squared||||
1723078|NCT00659061|3172800|Superiority or Other|||||||0.7||||||baseline|Chi-squared||||
1723079|NCT00659061|3172801|Superiority or Other|||||||0||||||endline|ANOVA|adjusted for baseline child age, sex, # of sprinkle sachet consumed, # of mths between enrollment and endline Hb measurement|||
1723080|NCT00659061|3172802|Superiority or Other||||||<|0.001||||||endline|Chi-squared||||
1723081|NCT00659061|3172802|Superiority or Other||||||<|0.34||||||baseline|Chi-squared||||
1723082|NCT00659061|3172803|Superiority or Other||||||<|0|||||||ANOVA|adjusted for baseline, child age, sex, number of sprinkles sachets consumed, number of mths between enrollment and endline Hb measurement)|||
1723083|NCT00659061|3172805|Superiority or Other||||||<|0.001||||||at endline|Chi-squared||||
1723084|NCT00659061|3172805|Superiority or Other||||||<|0.32||||||at baseline|Chi-squared||||
1723085|NCT00658606|3172884|Superiority or Other|||||||0.539||||||Results were adjusted for use of concomitant psoriasis treatment.|ANOVA|||Statistical Analysis applies to 'Change from Baseline'|
1723086|NCT00658606|3172885|Superiority or Other|||||||0.007||||||No adjustments were made for multiple comparisons.|Log Rank||||
1723087|NCT00658606|3172886|Superiority or Other|||||||0.001||||||No adjustments were made for multiple comparisons.|Log Rank||||
1723088|NCT00658606|3172887|Superiority or Other|||||||0.566||||||No adjustments were made for multiple comparisons.|Log Rank||||
1723089|NCT00658606|3172888|Superiority or Other|||||||0.147||||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'PASI 90 = Yes'|
1723090|NCT00658606|3172889|Superiority or Other|||||||0.026||||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'Clear or Almost Clear = Yes'|
1723091|NCT00658606|3172890|Superiority or Other|||||||0.052||||||No adjustments were made for multiple comparisons.|Fisher Exact|||Statistical Analysis applies to 'Clear or Almost Clear = Yes'|
1723092|NCT00658606|3172891|Superiority or Other|||||||0.382||||||Results were adjusted for use of concomitant psoriasis treatment.|ANOVA|||Statistical Analysis applies to 'Change from Baseline'|
1723093|NCT00658606|3172892|Superiority or Other|||||||0.001||||||No adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Statistical Analysis applies to 'Change from Baseline'|
1723094|NCT00658606|3172893|Superiority or Other|||||||0.037||||||No adjustments were made to multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1723095|NCT00658606|3172894|Superiority or Other|||||||0.032||||||No adjustments were made for multiple comparisons.|Fisher Exact||||
1723096|NCT00658359|3172912|Superiority or Other||Mean Difference (Final Values)|-1.13|Standard Error of the Mean|1.62||0.4853|2-Sided|95.0|-4.31|2.05|||Mixed Models Analysis|||Month 36 Satisfaction Converted Score|
1723594|NCT00657020|3173018|Superiority or Other|||||||0.54|||||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.|
1723097|NCT00658359|3172912|Superiority or Other||Mean Difference (Final Values)|0.45|Standard Error of the Mean|1.13||0.689|2-Sided|95.0|-1.77|2.67|||Mixed Models Analysis|||Month 36 Satisfaction Converted Score|
1723098|NCT00658359|3172912|Superiority or Other||Mean Difference (Final Values)|1.14|Standard Error of the Mean|1.02||0.2636|2-Sided|95.0|-0.86|3.13|||Mixed Models Analysis|||Month 36 Non-Pain Symptoms Converted Score|
1723099|NCT00658359|3172912|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.71||0.8111|2-Sided|95.0|-1.56|1.22|||Mixed Models Analysis|||Month 36 Non-Pain symptoms Converted Score|
1723100|NCT00658359|3172912|Superiority or Other||Mean Difference (Final Values)|0.96|Standard Error of the Mean|2.75||0.7272|2-Sided|95.0|-4.45|6.37|||Mixed Models Analysis|||Month 36 Pain Intensity Total Converted Score|
1723101|NCT00658359|3172912|Superiority or Other||Mean Difference (Final Values)|-1.6|Standard Error of the Mean|1.96||0.4135|2-Sided|95.0|-5.45|2.25|||Mixed Models Analysis|||Month 36 Pain Intensity Total Converted Score|
1723102|NCT00658359|3172912|Superiority or Other||Mean Difference (Final Values)|-0.89|Standard Error of the Mean|1.15||0.4405|2-Sided|95.0|-3.16|1.37|||Mixed Models Analysis|||Month 24 Satisfaction Converted Score|
1723103|NCT00658359|3172912|Superiority or Other||Mean Difference (Final Values)|0.89|Standard Error of the Mean|0.98||0.3656|2-Sided|95.0|-1.04|2.82|||Mixed Models Analysis|||Month 24 Satisfaction Converted Score|
1723104|NCT00658359|3172912|Superiority or Other||Mean Difference (Final Values)|0.81|Standard Error of the Mean|0.72||0.261|2-Sided|95.0|-0.6|2.21|||Mixed Models Analysis|||Month 24 Non-Pain Symptoms Converted Score|
1723105|NCT00658359|3172912|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.62||0.7503|2-Sided|95.0|-1.41|1.02|||Mixed Models Analysis|||Month 24 Non-Pain Symptoms Converted Score|
1723106|NCT00658359|3172912|Superiority or Other||Mean Difference (Final Values)|1.22|Standard Error of the Mean|1.97||0.5371|2-Sided|95.0|-2.65|5.09|||Mixed Models Analysis|||Month 24 Pain Intensity Total Converted Score|
1723107|NCT00658359|3172912|Superiority or Other||Mean Difference (Final Values)|-1.85|Standard Error of the Mean|1.72||0.2826|2-Sided|95.0|-5.22|1.53|||Mixed Models Analysis|||Month 24 Pain Intensity Total Converted Score|
1723108|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.14||0.6629|2-Sided|95.0|-0.21|0.33|||Mixed Models Analysis|||Month 36 Global Score|
1723109|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.1||0.9186|2-Sided|95.0|-0.2|0.18|||Mixed Models Analysis|||Month 36 Global Score|
1723110|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.2||0.6412|2-Sided|95.0|-0.49|0.3|||Mixed Models Analysis|||Month 36 Transplantation-Associated Psychological Distress|
1723111|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.14||0.7531|2-Sided|95.0|-0.24|0.33|||Mixed Models Analysis|||Month 36 Transplantation-Associated Psychological Distress|
1723112|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.17||0.0719|2-Sided|95.0|-0.65|0.03|||Mixed Models Analysis|||Month 36 Increased Growth of Gum and Hair|
1723113|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.13||0.0888|2-Sided|95.0|-0.46|0.03|||Mixed Models Analysis|||Month 36 Increased Growth of Gum and Hair|
1723114|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.2||0.4852|2-Sided|95.0|-0.25|0.53|||Mixed Models Analysis|||Month 36 Side Effects of Corticosteroids|
1723115|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.14||0.7147|2-Sided|95.0|-0.33|0.23|||Mixed Models Analysis|||Month 36 Side Effects of Corticosteroids|
1723116|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.18||0.3065|2-Sided|95.0|-0.17|0.54|||Mixed Models Analysis|||Month 36 Cardiac and Renal Dysfunction|
1723117|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.13||0.9698|2-Sided|95.0|-0.26|0.25|||Mixed Models Analysis|||Month 36 Cardiac and Renal Dysfunction|
1723118|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.19||0.3253|2-Sided|95.0|-0.18|0.55|||Mixed Models Analysis|||Month 36 Limited Cognitive Capacity|
1723119|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.13||0.6545|2-Sided|95.0|-0.2|0.32|||Mixed Models Analysis|||Month 36 Limited Cognitive Capacity|
1723120|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.18||0.3392|2-Sided|95.0|-0.18|0.53|||Mixed Models Analysis|||Month 36 Limited Physical Capacity|
1723121|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.13||0.8682|2-Sided|95.0|-0.28|0.23|||Mixed Models Analysis|||Month 36 Limited Physical Capacity|
1723122|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.09||0.9297|2-Sided|95.0|-0.18|0.19|||Mixed Models Analysis|||Month 24 Global Score|
1723123|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.08||0.6724|2-Sided|95.0|-0.13|0.2|||Mixed Models Analysis|||Month 24 Global Score|
1723124|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.14||0.8986|2-Sided|95.0|-0.25|0.29|||Mixed Models Analysis|||Month 24 Transplantation-Associated Psychological Distress|
1723125|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.12||0.2012|2-Sided|95.0|-0.08|0.4|||Mixed Models Analysis|||Month 24 Transplantation-Associated Psychological Distress|
1723126|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|0.12||0.002|2-Sided|95.0|-0.59|-0.13|||Mixed Models Analysis|||Month 24 Increased Growth of Gum and Hair|
1723127|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.1||0.001|2-Sided|95.0|-0.55|-0.14|||Mixed Models Analysis|||Month 24 Increased Growth of Gum and Hair|
1723128|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.13||0.1918|2-Sided|95.0|-0.09|0.44|||Mixed Models Analysis|||Month 24 Side Effects of Corticosteroids|
1723129|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.12||0.2133|2-Sided|95.0|-0.09|0.39|||Mixed Models Analysis|||Month 24 Side Effects of Corticosteroids|
1723130|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.12||0.4241|2-Sided|95.0|-0.34|0.14|||Mixed Models Analysis|||Month 24 Cardiac and Renal Dysfunction|
1723131|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.11||0.6416|2-Sided|95.0|-0.27|0.17|||Mixed Models Analysis|||Month 24 Cardiac and Renal Dysfunction|
1723132|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.13||0.3679|2-Sided|95.0|-0.13|0.36|||Mixed Models Analysis|||Month 24 Limited Cognitive Capacity|
1723133|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.11||0.4858|2-Sided|95.0|-0.14|0.3|||Mixed Models Analysis|||Month 24 Limited Cognitive Capacity|
1723134|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.12||0.3223|2-Sided|95.0|-0.12|0.36|||Mixed Models Analysis|||Month 24 Limited Physical Capacity|
1723135|NCT00658359|3172913|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.11||0.3093|2-Sided|95.0|-0.1|0.33|||Mixed Models Analysis|||Month 24 Limited Physical Capacity|
1723136|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|2.86|Standard Error of the Mean|2.91||0.3264|2-Sided|95.0|-2.86|8.59|||Mixed Models Analysis|||Month 36: Mental Component Summary|
1723137|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|4.05|Standard Error of the Mean|2.25||0.0727|2-Sided|95.0|-0.37|8.47|||Mixed Models Analysis|||Month 36: Mental Component Summary|
1723138|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-1.48|Standard Error of the Mean|2.53||0.5582|2-Sided|95.0|-6.45|3.49|||Mixed Models Analysis|||Month 36: Physical Component Summary|
1723139|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-0.55|Standard Error of the Mean|1.97||0.7786|2-Sided|95.0|-4.42|3.31|||Mixed Models Analysis|||Month 36: Physical Component Summary|
1723140|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|0.37|Standard Error of the Mean|0.24||0.1147|2-Sided|95.0|-0.09|0.84|||Mixed Models Analysis|||Month 36: TR Scale Score|
1723141|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.18||0.2965|2-Sided|95.0|-0.17|0.55|||Mixed Models Analysis|||Month 36: TR Scale Score|
1723142|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|0.38|Standard Error of the Mean|3.05||0.9008|2-Sided|95.0|-5.62|6.38|||Mixed Models Analysis|||Month 36: Mental Health|
1723143|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|1.63|Standard Error of the Mean|2.36||0.4916|2-Sided|95.0|-3.02|6.27|||Mixed Models Analysis|||Month 36: Mental Health|
1723144|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|1.23|Standard Error of the Mean|3.52||0.7266|2-Sided|95.0|-5.69|8.16|||Mixed Models Analysis|||Month 36: Role Emotional|
1723145|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|5.62|Standard Error of the Mean|2.72||0.0393|2-Sided|95.0|0.28|10.97|||Mixed Models Analysis|||Month 36: Role Emotional|
1723146|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-0.63|Standard Error of the Mean|3.03||0.8349|2-Sided|95.0|-6.58|5.32|||Mixed Models Analysis|||Month 36: Social Functioning|
1723147|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|2.47|Standard Error of the Mean|2.33||0.2895|2-Sided|95.0|-2.11|7.05|||Mixed Models Analysis|||Month 36: Social Functioning|
1723148|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|4.43|Standard Error of the Mean|2.86||0.1218|2-Sided|95.0|-1.18|10.04|||Mixed Models Analysis|||Month 36: Vitality|
1723149|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|1.44|Standard Error of the Mean|2.19||0.5112|2-Sided|95.0|-2.87|5.75|||Mixed Models Analysis|||Month 36: Vitality|
1723150|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|0.97|Standard Error of the Mean|2.66||0.7165|2-Sided|95.0|-4.26|6.2|||Mixed Models Analysis|||Month 36: General Health|
1723151|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|1.77|Standard Error of the Mean|2.08||0.3947|2-Sided|95.0|-2.31|5.86|||Mixed Models Analysis|||Month 36: General Health|
1723152|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|3.24||0.9078|2-Sided|95.0|-6.74|5.99|||Mixed Models Analysis|||Month 36: Bodily Pain|
1723153|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|2.09|Standard Error of the Mean|2.5||0.4033|2-Sided|95.0|-2.82|7.0|||Mixed Models Analysis|||Month 36: Bodily Pain|
1723154|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-2.0|Standard Error of the Mean|3.18||0.5291|2-Sided|95.0|-8.24|4.24|||Mixed Models Analysis|||Month 36: Role Physical|
1723155|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|0.52|Standard Error of the Mean|2.47||0.8335|2-Sided|95.0|-4.33|5.37|||Mixed Models Analysis|||Month 36: Role Physical|
1723156|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-2.44|Standard Error of the Mean|2.6||0.3486|2-Sided|95.0|-7.54|2.66|||Mixed Models Analysis|||Month 36: Physical Functioning|
1723157|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-1.65|Standard Error of the Mean|2.03||0.4174|2-Sided|95.0|-5.63|2.34|||Mixed Models Analysis|||Month 36: Physical Functioning|
1723158|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|3.26|Standard Error of the Mean|2.12||0.1248|2-Sided|95.0|-0.91|7.43|||Mixed Models Analysis|||Month 24: Mental Component Summary|
1723159|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|0.96|Standard Error of the Mean|1.92||0.6154|2-Sided|95.0|-2.81|4.73|||Mixed Models Analysis|||Month 24: Mental Component Summary|
1723160|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-2.42|Standard Error of the Mean|1.84||0.188|2-Sided|95.0|-6.04|1.19|||Mixed Models Analysis|||Month 24: Physical Component Summary|
1723161|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|1.68||0.9966|2-Sided|95.0|-3.31|3.29|||Mixed Models Analysis|||Month 24: Physical Component Summary|
1723162|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.17||0.1802|2-Sided|95.0|-0.11|0.57|||Mixed Models Analysis|||Month 24: TR Scale Score|
1723163|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.16||0.1754|2-Sided|95.0|-0.1|0.52|||Mixed Models Analysis|||Month 24: TR Scale Score|
1723164|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|3.56|Standard Error of the Mean|2.22||0.1092|2-Sided|95.0|-0.8|7.92|||Mixed Models Analysis|||Month 24: Mental Health|
1723165|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-1.69|Standard Error of the Mean|2.01||0.4023|2-Sided|95.0|-5.64|2.27|||Mixed Models Analysis|||Month 24: Mental Health|
1723166|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|2.54||0.852|2-Sided|95.0|-5.47|4.52|||Mixed Models Analysis|||Month 24: Role Emotional|
1723167|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|3.82|Standard Error of the Mean|2.31||0.0997|2-Sided|95.0|-0.73|8.37|||Mixed Models Analysis|||Month 24: Role Emotional|
1723168|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|0.39|Standard Error of the Mean|2.2||0.8583|2-Sided|95.0|-3.94|4.72|||Mixed Models Analysis|||Month 24: Social Functioning|
1723169|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|1.98||0.94|2-Sided|95.0|-4.05|3.75|||Mixed Models Analysis|||Month 24: Social Functioning|
1723170|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|1.76|Standard Error of the Mean|2.07||0.396|2-Sided|95.0|-2.31|5.83|||Mixed Models Analysis|||Month 24: Vitality|
1723171|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|1.87||0.9799|2-Sided|95.0|-3.72|3.62|||Mixed Models Analysis|||Month 24: Vitality|
1723172|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|1.09|Standard Error of the Mean|1.95||0.578|2-Sided|95.0|-2.75|4.92|||Mixed Models Analysis|||Month 24: General Health|
1723173|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|1.74|Standard Error of the Mean|1.78||0.329|2-Sided|95.0|-1.76|5.23|||Mixed Models Analysis|||Month 24: General Health|
1723174|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|2.33||0.9673|2-Sided|95.0|-4.48|4.67|||Mixed Models Analysis|||Month 24: Bodily Pain|
1723175|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|0.29|Standard Error of the Mean|2.12||0.8932|2-Sided|95.0|-3.89|4.46|||Mixed Models Analysis|||Month 24: Bodily Pain|
1723176|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-1.96|Standard Error of the Mean|2.3||0.3938|2-Sided|95.0|-6.49|2.56|||Mixed Models Analysis|||Month 24: Role Physical|
1723177|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|1.36|Standard Error of the Mean|2.1||0.5182|2-Sided|95.0|-2.77|5.49|||Mixed Models Analysis|||Month 24: Role Physical|
1723178|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-3.57|Standard Error of the Mean|1.89||0.0595|2-Sided|95.0|-7.29|0.14|||Mixed Models Analysis|||Month 24: Physical Functioning|
1723179|NCT00658359|3172914|Superiority or Other||Mean Difference (Final Values)|-2.04|Standard Error of the Mean|1.73||0.2393|2-Sided|95.0|-5.45|1.36|||Mixed Models Analysis|||Month 24: Physical Functioning|
1723180|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|9.59|Standard Error of the Mean|5.19||0.066|2-Sided|60.0|5.22|13.97|||Mixed Models Analysis|||Month 72|
1723181|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|14.66|Standard Error of the Mean|5.04||0.0041|2-Sided|60.0|10.4|18.91|||Mixed Models Analysis|||Month 72|
1723182|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|9.77|Standard Error of the Mean|4.93||0.0491|2-Sided|60.0|5.61|13.93|||Mixed Models Analysis|||Month 66|
1723183|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|13.63|Standard Error of the Mean|4.8||0.005|2-Sided|60.0|9.58|17.67|||Mixed Models Analysis|||Month 66|
1723184|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|8.77|Standard Error of the Mean|4.87||0.0736|2-Sided|60.0|4.66|12.88|||Mixed Models Analysis|||Month 60|
1723185|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|13.39|Standard Error of the Mean|4.74||0.0053|2-Sided|60.0|9.39|17.39|||Mixed Models Analysis|||Month 60|
1723186|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|12.15|Standard Error of the Mean|4.87||0.0136|2-Sided|60.0|8.04|16.26|||Mixed Models Analysis|||Month 54|
1723187|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|16.61|Standard Error of the Mean|4.74||0.0006|2-Sided|60.0|12.62|20.61|||Mixed Models Analysis|||Month 54|
1723188|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|9.12|Standard Error of the Mean|4.78||0.058|2-Sided|60.0|5.09|13.15|||Mixed Models Analysis|||Month 48|
1723189|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|13.58|Standard Error of the Mean|4.65||0.0039|2-Sided|60.0|9.66|17.5|||Mixed Models Analysis|||Month 48|
1723190|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|8.55|Standard Error of the Mean|4.37||0.0519|2-Sided|60.0|4.87|12.24|||Mixed Models Analysis|||Month 42|
1723191|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|14.7|Standard Error of the Mean|4.25||0.0007|2-Sided|60.0|11.11|18.28|||Mixed Models Analysis|||Month 42|
1723192|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|8.9|Standard Error of the Mean|4.43||0.0462|2-Sided|60.0|5.16|12.64|||Mixed Models Analysis|||Month 36|
1723193|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|14.72|Standard Error of the Mean|4.31||0.0008|2-Sided|60.0|11.09|18.36|||Mixed Models Analysis|||Month 36|
1723194|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|10.63|Standard Error of the Mean|3.97||0.0082|2-Sided|60.0|7.27|13.98|||Mixed Models Analysis|||Month 30|
1723195|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|19.29|Standard Error of the Mean|3.86|<|0.0001|2-Sided|60.0|16.03|22.55|||Mixed Models Analysis|||Month 30|
1723606|NCT00657020|3173020|Superiority or Other|||||||0.6418|||||||ANOVA|||Region of interest is left visual cortex.|
1723196|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|11.89|Standard Error of the Mean|3.54|<|0.001|2-Sided|60.0|8.91|14.88|||Mixed Models Analysis|||Month 24|
1723197|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|15.63|Standard Error of the Mean|3.44|<|0.0001|2-Sided|60.0|12.72|18.53|||Mixed Models Analysis|||Month 24|
1723198|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|11.56|Standard Error of the Mean|3.43|<|0.0009|2-Sided|60.0|8.67|14.45|||Mixed Models Analysis|||Month 18|
1723199|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|13.53|Standard Error of the Mean|3.33|<|0.0001|2-Sided|60.0|10.71|16.34|||Mixed Models Analysis|||Month 18|
1723200|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|13.97|Standard Error of the Mean|2.95|<|0.0001|2-Sided|60.0|11.49|16.46|||Mixed Models Analysis|||Month 15|
1723201|NCT00658359|3172915|Superiority or Other||Mean Difference (Final Values)|15.87|Standard Error of the Mean|2.86|<|0.0001|2-Sided|60.0|13.46|18.29|||Mixed Models Analysis|||Month 15|
1723202|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|4.71|Standard Error of the Mean|7.83||0.5487|2-Sided|60.0|-1.91|11.33|||Mixed Models Analysis|||Month 72|
1723203|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|17.16|Standard Error of the Mean|6.77||0.0128|2-Sided|60.0|11.44|22.88|||Mixed Models Analysis|||Month 72|
1723204|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|5.42|Standard Error of the Mean|6.38||0.3965|2-Sided|60.0|0.04|10.81|||Mixed Models Analysis|||Month 66|
1723205|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|9.99|Standard Error of the Mean|5.68||0.081|2-Sided|60.0|5.2|14.79|||Mixed Models Analysis|||Month 66|
1723206|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|3.66|Standard Error of the Mean|6.86||0.5947|2-Sided|60.0|-2.14|9.46|||Mixed Models Analysis|||Month 66|
1723207|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|8.03|Standard Error of the Mean|5.92||0.1782|2-Sided|60.0|3.02|13.03|||Mixed Models Analysis|||Month 60|
1723208|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|11.79|Standard Error of the Mean|6.52||0.0724|2-Sided|60.0|6.29|17.29|||Mixed Models Analysis|||Month 54|
1723209|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|16.97|Standard Error of the Mean|5.7||0.0034|2-Sided|60.0|12.17|21.78|||Mixed Models Analysis|||Month 54|
1723210|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|9.8|Standard Error of the Mean|6.31||0.1226|2-Sided|60.0|4.47|15.12|||Mixed Models Analysis|||Month 48|
1723211|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|16.33|Standard Error of the Mean|5.64||0.0043|2-Sided|60.0|11.57|21.09|||Mixed Models Analysis|||Month 48|
1723212|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|12.24|Standard Error of the Mean|5.65||0.0316|2-Sided|60.0|7.47|17.01|||Mixed Models Analysis|||Month 42|
1723213|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|16.32|Standard Error of the Mean|5.12||0.0018|2-Sided|60.0|11.99|20.64|||Mixed Models Analysis|||Month 42|
1723214|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|14.93|Standard Error of the Mean|6.0||0.0137|2-Sided|60.0|9.87|19.99|||Mixed Models Analysis|||Month 36|
1723215|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|15.19|Standard Error of the Mean|5.51||0.0065|2-Sided|60.0|10.55|19.84|||Mixed Models Analysis|||Month 36|
1723216|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|16.45|Standard Error of the Mean|5.29||0.0022|2-Sided|60.0|11.99|20.91|||Mixed Models Analysis|||Month 30|
1723217|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|18.54|Standard Error of the Mean|5.06||0.0003|2-Sided|60.0|14.27|22.81|||Mixed Models Analysis|||Month 30|
1723218|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|14.93|Standard Error of the Mean|4.88||0.0026|2-Sided|60.0|10.81|19.04|||Mixed Models Analysis|||Month 24|
1723219|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|15.02|Standard Error of the Mean|4.72||0.0017|2-Sided|60.0|11.04|19.0|||Mixed Models Analysis|||Month 24|
1723220|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|13.57|Standard Error of the Mean|4.64||0.0039|2-Sided|60.0|9.65|17.48|||Mixed Models Analysis|||Month 18|
1723221|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|13.96|Standard Error of the Mean|4.5||0.0023|2-Sided|60.0|10.16|17.76|||Mixed Models Analysis|||Month 18|
1723222|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|14.93|Standard Error of the Mean|4.47||0.001|2-Sided|60.0|11.16|18.7|||Mixed Models Analysis|||Month 15|
1723223|NCT00658359|3172916|Superiority or Other||Mean Difference (Final Values)|14.48|Standard Error of the Mean|4.33||0.001|2-Sided|60.0|10.83|18.13|||Mixed Models Analysis|||Month 15|
1723224|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|4.27|Standard Error of the Mean|6.13||0.4875|2-Sided|60.0|-0.91|9.45|||Mixed Models Analysis|||Month 72|
1723225|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|13.03|Standard Error of the Mean|5.25||0.015|2-Sided|60.0|8.59|17.46|||Mixed Models Analysis|||Month 72|
1723226|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|6.02|Standard Error of the Mean|4.89||0.221|2-Sided|60.0|1.89|10.15|||Mixed Models Analysis|||Month 66|
1723227|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|7.75|Standard Error of the Mean|4.23||0.0702|2-Sided|60.0|4.17|11.33|||Mixed Models Analysis|||Month 66|
1723228|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|4.11|Standard Error of the Mean|4.28||0.3391|2-Sided|60.0|0.49|7.73|||Mixed Models Analysis|||Month 60|
1723229|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|7.72|Standard Error of the Mean|3.7||0.0399|2-Sided|60.0|4.59|10.86|||Mixed Models Analysis|||Month 60|
1723230|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|10.23|Standard Error of the Mean|4.72||0.0322|2-Sided|60.0|6.24|14.22|||Mixed Models Analysis|||Month 54|
1723231|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|14.04|Standard Error of the Mean|4.02||0.0007|2-Sided|60.0|10.64|17.43|||Mixed Models Analysis|||Month 54|
1723232|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|7.6|Standard Error of the Mean|4.29||0.0782|2-Sided|60.0|3.99|11.22|||Mixed Models Analysis|||Month 48|
1723233|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|12.4|Standard Error of the Mean|3.77||0.0013|2-Sided|60.0|9.22|15.58|||Mixed Models Analysis|||Month 48|
1723234|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|8.99|Standard Error of the Mean|3.76||0.0182|2-Sided|60.0|5.81|12.16|||Mixed Models Analysis|||Month 42|
1723235|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|12.42|Standard Error of the Mean|3.38||0.0004|2-Sided|60.0|9.56|15.27|||Mixed Models Analysis|||Month 42|
1723236|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|12.56|Standard Error of the Mean|3.98||0.0019|2-Sided|60.0|9.2|15.92|||Mixed Models Analysis|||Month 36|
1723237|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|12.17|Standard Error of the Mean|3.61||0.001|2-Sided|60.0|9.12|15.21|||Mixed Models Analysis|||Month 36|
1723238|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|13.61|Standard Error of the Mean|3.56||0.0002|2-Sided|60.0|10.61|16.61|||Mixed Models Analysis|||Month 30|
1723239|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|15.86|Standard Error of the Mean|3.35|<|0.0001|2-Sided|60.0|13.03|18.69|||Mixed Models Analysis|||Month 30|
1723240|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|13.71|Standard Error of the Mean|3.12|<|0.0001|2-Sided|60.0|11.08|16.35|||Mixed Models Analysis|||Month 24|
1723241|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|12.86|Standard Error of the Mean|3.0|<|0.0001|2-Sided|60.0|10.32|15.39|||Mixed Models Analysis|||Month 24|
1723242|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|11.98|Standard Error of the Mean|3.09|<|0.0002|2-Sided|60.0|9.37|14.59|||Mixed Models Analysis|||Month 18|
1723243|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|11.48|Standard Error of the Mean|3.0|<|0.0002|2-Sided|60.0|8.95|14.0|||Mixed Models Analysis|||Month 18|
1723244|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|13.39|Standard Error of the Mean|2.88|<|0.0001|2-Sided|60.0|10.96|15.82|||Mixed Models Analysis|||Month 15|
1723245|NCT00658359|3172917|Superiority or Other||Mean Difference (Final Values)|12.76|Standard Error of the Mean|2.79|<|0.0001|2-Sided|60.0|10.4|15.11|||Mixed Models Analysis|||Month 15|
1723246|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|-7.19|Standard Error of the Mean|12.96||0.5793|2-Sided|60.0|-18.1|3.72|||Mixed Models Analysis|||Month 72|
1723247|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|-1.79|Standard Error of the Mean|11.34||0.8747|2-Sided|60.0|-11.34|7.76|||Mixed Models Analysis|||Month 72|
1723248|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|4.14|Standard Error of the Mean|12.79||0.7465|2-Sided|60.0|-6.63|14.9|||Mixed Models Analysis|||Month 66|
1723249|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|-1.17|Standard Error of the Mean|10.7||0.9132|2-Sided|60.0|-10.18|7.84|||Mixed Models Analysis|||Month 66|
1723250|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|-2.25|Standard Error of the Mean|12.35||0.8554|2-Sided|60.0|-12.65|8.15|||Mixed Models Analysis|||Month 60|
1723251|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|-3.11|Standard Error of the Mean|10.23||0.7613|2-Sided|60.0|-11.72|5.5|||Mixed Models Analysis|||Month 60|
1723252|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|12.88|Standard Error of the Mean|11.93||0.2803|2-Sided|60.0|2.84|22.93|||Mixed Models Analysis|||Month 54|
1723253|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|-3.88|Standard Error of the Mean|9.44||0.6814|2-Sided|60.0|-11.82|4.07|||Mixed Models Analysis|||Month 54|
1723254|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|2.94|Standard Error of the Mean|11.64||0.8009|2-Sided|60.0|-6.86|12.74|||Mixed Models Analysis|||Month 48|
1723255|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|8.72|Standard Error of the Mean|9.46||0.3572|2-Sided|60.0|0.75|16.69|||Mixed Models Analysis|||Month 48|
1723256|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|-12.94|Standard Error of the Mean|11.35||0.2547|2-Sided|60.0|-22.5|-3.38|||Mixed Models Analysis|||Month 42|
1723257|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|7.33|Standard Error of the Mean|9.34||0.4328|2-Sided|60.0|-0.53|15.19|||Mixed Models Analysis|||Month 42|
1723258|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|10.14|Standard Error of the Mean|11.2||0.365|2-Sided|60.0|0.72|19.57|||Mixed Models Analysis|||Month 36|
1723259|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|10.39|Standard Error of the Mean|9.08||0.2531|2-Sided|60.0|2.74|18.03|||Mixed Models Analysis|||Month 36|
1723260|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|2.43|Standard Error of the Mean|9.57||0.7998|2-Sided|60.0|-5.63|10.49|||Mixed Models Analysis|||Match 30|
1723261|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|2.74|Standard Error of the Mean|8.78||0.7548|2-Sided|60.0|-4.65|10.14|||Mixed Models Analysis|||Month 30|
1723262|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|-9.76|Standard Error of the Mean|8.58||0.2559|2-Sided|60.0|-16.99|-2.53|||Mixed Models Analysis|||Month 24|
1723263|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|-4.43|Standard Error of the Mean|8.06||0.5829|2-Sided|60.0|-11.21|2.36|||Mixed Models Analysis|||Month 24|
1723264|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|-5.44|Standard Error of the Mean|8.28||0.5114|2-Sided|60.0|-12.42|1.53|||Mixed Models Analysis|||Month 18|
1723265|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|-6.84|Standard Error of the Mean|7.92||0.3881|2-Sided|60.0|-13.51|-0.17|||Mixed Models Analysis|||Month 18|
1723266|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|2.75|Standard Error of the Mean|8.28||0.7396|2-Sided|60.0|-4.22|9.73|||Mixed Models Analysis|||Month 15|
1723267|NCT00658359|3172919|Superiority or Other||Mean Difference (Final Values)|-2.33|Standard Error of the Mean|7.93||0.7693|2-Sided|60.0|-9.01|4.35|||Mixed Models Analysis|||Month 15|
1723268|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|18.25|Standard Error of the Mean|36.98||0.6218|2-Sided|60.0|-12.89|49.38|||Mixed Models Analysis|||Month 72|
1723269|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|22.06|Standard Error of the Mean|30.7||0.4724|2-Sided|60.0|-3.78|47.91|||Mixed Models Analysis|||Month 72|
1723270|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-7.11|Standard Error of the Mean|36.06||0.8438|2-Sided|60.0|-37.47|23.26|||Mixed Models Analysis|||Month 66|
1723271|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|8.35|Standard Error of the Mean|28.73||0.7713|2-Sided|60.0|-15.83|32.54|||Mixed Models Analysis|||Month 66|
1723272|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-14.0|Standard Error of the Mean|34.44||0.6845|2-Sided|60.0|-42.99|15.0|||Mixed Models Analysis|||Month 60|
1723273|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|16.93|Standard Error of the Mean|27.12||0.5326|2-Sided|60.0|-5.9|39.76|||Mixed Models Analysis|||Month 60|
1723274|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|14.67|Standard Error of the Mean|33.1||0.6578|2-Sided|60.0|-13.2|42.54|||Mixed Models Analysis|||Month 54|
1723275|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|5.61|Standard Error of the Mean|25.15||0.8236|2-Sided|60.0|-15.57|26.79|||Mixed Models Analysis|||Month 54|
1723276|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-10.25|Standard Error of the Mean|32.08||0.7492|2-Sided|60.0|-37.26|16.75|||Mixed Models Analysis|||Month 48|
1723277|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|30.49|Standard Error of the Mean|24.92||0.2214|2-Sided|60.0|9.51|51.47|||Mixed Models Analysis|||Month 48|
1723278|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-30.3|Standard Error of the Mean|30.65||0.323|2-Sided|60.0|-56.11|-4.5|||Mixed Models Analysis|||Month 42|
1723279|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|4.16|Standard Error of the Mean|24.28||0.8639|2-Sided|60.0|-16.28|24.6|||Mixed Models Analysis|||Month 42|
1723280|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-21.03|Standard Error of the Mean|28.58||0.462|2-Sided|60.0|-45.09|3.03|||Mixed Models Analysis|||Month 36|
1723281|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-28.75|Standard Error of the Mean|23.15||0.2146|2-Sided|60.0|-48.24|-9.25|||Mixed Models Analysis|||Month 36|
1723282|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-3.92|Standard Error of the Mean|24.0||0.8701|2-Sided|60.0|-24.13|16.28|||Mixed Models Analysis|||Month 30|
1723283|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-45.43|Standard Error of the Mean|21.76||0.037|2-Sided|60.0|-63.75|-27.11|||Mixed Models Analysis|||Month 30|
1723284|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-41.72|Standard Error of the Mean|21.38||0.0512|2-Sided|60.0|-59.72|-23.73|||Mixed Models Analysis|||Month 24|
1723285|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-21.0|Standard Error of the Mean|19.99||0.2937|2-Sided|60.0|-37.83|-4.17|||Mixed Models Analysis|||Month 24|
1723286|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-36.86|Standard Error of the Mean|20.47||0.072|2-Sided|60.0|-54.1|-19.63|||Mixed Models Analysis|||Month 18|
1723287|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-18.66|Standard Error of the Mean|19.61||0.3415|2-Sided|60.0|-35.17|-2.15|||Mixed Models Analysis|||Month 18|
1723288|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-9.95|Standard Error of the Mean|20.33||0.6249|2-Sided|60.0|-27.07|7.17|||Mixed Models Analysis|||Month 15|
1723289|NCT00658359|3172923|Superiority or Other||Mean Difference (Final Values)|-6.11|Standard Error of the Mean|19.53||0.7543|2-Sided|60.0|-22.55|10.33|||Mixed Models Analysis|||Month 15|
1723290|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|2.13|Standard Error of the Mean|4.75||0.654|2-Sided|60.0|-1.87|6.13|||Mixed Models Analysis|||Month 72|
1723291|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|5.99|Standard Error of the Mean|3.95||0.1295|2-Sided|60.0|2.67|9.32|||Mixed Models Analysis|||Month 72|
1723292|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|1.39|Standard Error of the Mean|4.64||0.7642|2-Sided|60.0|-2.51|5.29|||Mixed Models Analysis|||Month 66|
1723293|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|7.42|Standard Error of the Mean|3.7||0.0448|2-Sided|60.0|4.31|10.54|||Mixed Models Analysis|||Month 66|
1723294|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|4.26|Standard Error of the Mean|4.43||0.3357|2-Sided|60.0|0.54|7.99|||Mixed Models Analysis|||Month 60|
1723295|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|5.48|Standard Error of the Mean|3.49||0.1168|2-Sided|60.0|2.54|8.41|||Mixed Models Analysis|||Month 60|
1723296|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|-2.17|Standard Error of the Mean|4.26||0.6103|2-Sided|60.0|-5.75|1.41|||Mixed Models Analysis|||Month 54|
1723297|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|5.63|Standard Error of the Mean|3.23||0.0819|2-Sided|60.0|2.91|8.35|||Mixed Models Analysis|||Month 54|
1723298|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|-1.04|Standard Error of the Mean|4.13||0.8018|2-Sided|60.0|-4.51|2.44|||Mixed Models Analysis|||Month 48|
1723299|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|7.08|Standard Error of the Mean|3.2||0.0274|2-Sided|60.0|4.38|9.77|||Mixed Models Analysis|||Month 48|
1723300|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|5.35|Standard Error of the Mean|3.95||0.176|2-Sided|60.0|2.02|8.67|||Mixed Models Analysis|||Month 42|
1723301|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|6.08|Standard Error of the Mean|3.12||0.052|2-Sided|60.0|3.45|8.71|||Mixed Models Analysis|||Month 42|
1723302|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|4.13|Standard Error of the Mean|3.69||0.2636|2-Sided|60.0|1.02|7.23|||Mixed Models Analysis|||Month 36|
1723595|NCT00657020|3173019|Superiority or Other|||||||0.0959|||||||ANOVA|||Null hypothesis considered response time of treatments in comparison to be equal.|
1723303|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|9.45|Standard Error of the Mean|2.98||0.0015|2-Sided|60.0|6.95|11.96|||Mixed Models Analysis|||Month 36|
1723304|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|4.29|Standard Error of the Mean|3.09||0.1654|2-Sided|60.0|1.69|6.89|||Mixed Models Analysis|||Month 30|
1723305|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|10.9|Standard Error of the Mean|2.8||0.0001|2-Sided|60.0|8.54|13.26|||Mixed Models Analysis|||Month 30|
1723306|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|2.04|Standard Error of the Mean|2.75||0.4565|2-Sided|60.0|-0.27|4.36|||Mixed Models Analysis|||Month 24|
1723307|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|8.37|Standard Error of the Mean|2.56||0.0011|2-Sided|60.0|6.21|10.53|||Mixed Models Analysis|||Month 24|
1723308|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|5.3|Standard Error of the Mean|2.63||0.0437|2-Sided|60.0|3.09|7.51|||Mixed Models Analysis|||Month 18|
1723309|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|9.4|Standard Error of the Mean|2.51||0.0002|2-Sided|60.0|7.28|11.51|||Mixed Models Analysis|||Month 18|
1723310|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|5.32|Standard Error of the Mean|2.61||0.0418|2-Sided|60.0|3.12|7.52|||Mixed Models Analysis|||Month 15|
1723311|NCT00658359|3172924|Superiority or Other||Mean Difference (Final Values)|9.79|Standard Error of the Mean|2.5|<|0.0001|2-Sided|60.0|7.68|11.9|||Mixed Models Analysis|||Month 15|
1723312|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|-13.07|Standard Error of the Mean|12.1||0.2804|2-Sided|60.0|-23.26|-2.88|||Mixed Models Analysis|||Month 72|
1723313|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|6.98|Standard Error of the Mean|10.34||0.4997|2-Sided|60.0|-1.72|15.69|||Mixed Models Analysis|||Month 72|
1723314|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|-1.87|Standard Error of the Mean|11.84||0.8747|2-Sided|60.0|-11.83|8.1|||Mixed Models Analysis|||Month 66|
1723315|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|19.43|Standard Error of the Mean|9.69||0.0453|2-Sided|60.0|11.27|27.59|||Mixed Models Analysis|||Month 66|
1723316|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|-7.59|Standard Error of the Mean|11.28||0.5016|2-Sided|60.0|-17.09|1.91|||Mixed Models Analysis|||Month 60|
1723317|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|18.34|Standard Error of the Mean|9.15||0.0453|2-Sided|60.0|10.63|26.05|||Mixed Models Analysis|||Month 60|
1723318|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|-10.61|Standard Error of the Mean|10.86||0.3288|2-Sided|60.0|-19.75|-1.47|||Mixed Models Analysis|||Month 54|
1723319|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|21.18|Standard Error of the Mean|8.44||0.0122|2-Sided|60.0|14.08|28.29|||Mixed Models Analysis|||Month 54|
1723320|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|-3.44|Standard Error of the Mean|10.54||0.7444|2-Sided|60.0|-12.31|5.44|||Mixed Models Analysis|||Month 48|
1723321|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|18.62|Standard Error of the Mean|8.41||0.027|2-Sided|60.0|11.54|25.7|||Mixed Models Analysis|||Month 48|
1723322|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|10.77|Standard Error of the Mean|10.12||0.2876|2-Sided|60.0|2.25|19.29|||Mixed Models Analysis|||Month 42|
1723323|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|11.53|Standard Error of the Mean|8.25||0.1625|2-Sided|60.0|4.59|18.48|||Mixed Models Analysis|||Month 42|
1723324|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|-3.27|Standard Error of the Mean|9.5||0.7307|2-Sided|60.0|-11.27|4.73|||Mixed Models Analysis|||Month 36|
1723325|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|10.46|Standard Error of the Mean|7.75||0.1776|2-Sided|60.0|3.93|16.99|||Mixed Models Analysis|||Month 36|
1723326|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|5.66|Standard Error of the Mean|7.99||0.479|2-Sided|60.0|-1.07|12.39|||Mixed Models Analysis|||Month 30|
1723327|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|18.45|Standard Error of the Mean|7.27||0.0113|2-Sided|60.0|12.33|24.57|||Mixed Models Analysis|||Month 30|
1723328|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|-6.5|Standard Error of the Mean|7.04||0.3554|2-Sided|60.0|-12.43|-0.58|||Mixed Models Analysis|||Month 24|
1723329|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|8.02|Standard Error of the Mean|6.7||0.2319|2-Sided|60.0|2.37|13.66|||Mixed Models Analysis|||Month 24|
1723330|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|-2.95|Standard Error of the Mean|6.73||0.6608|2-Sided|60.0|-8.62|2.71|||Mixed Models Analysis|||Month 18|
1723331|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|6.54|Standard Error of the Mean|6.56||0.3191|2-Sided|60.0|1.02|12.06|||Mixed Models Analysis|||Month 18|
1723332|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|-4.37|Standard Error of the Mean|6.75||0.5176|2-Sided|60.0|-10.06|1.31|||Mixed Models Analysis|||Month 15|
1723333|NCT00658359|3172925|Superiority or Other||Mean Difference (Final Values)|6.62|Standard Error of the Mean|6.57||0.3139|2-Sided|60.0|1.09|12.14|||Mixed Models Analysis|||Month 15|
1723334|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|-6.14|Standard Error of the Mean|15.48||0.6918|2-Sided|60.0|-19.18|6.9|||Mixed Models Analysis|||Month 72|
1723335|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|20.38|Standard Error of the Mean|12.91||0.1146|2-Sided|60.0|9.51|31.24|||Mixed Models Analysis|||Month 72|
1723336|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|-1.85|Standard Error of the Mean|15.12||0.9026|2-Sided|60.0|-14.58|10.88|||Mixed Models Analysis|||Month 66|
1723337|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|27.78|Standard Error of the Mean|12.08||0.0216|2-Sided|60.0|17.61|37.95|||Mixed Models Analysis|||Month 66|
1723596|NCT00657020|3173019|Superiority or Other|||||||0.1963|||||||ANOVA|||Null hypothesis considered response time of treatments in comparison to be equal.|
1723338|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|-5.95|Standard Error of the Mean|14.44||0.6802|2-Sided|60.0|-18.11|6.2|||Mixed Models Analysis|||Month 60|
1723339|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|30.37|Standard Error of the Mean|11.39||0.0078|2-Sided|60.0|20.78|39.96|||Mixed Models Analysis|||Month 60|
1723340|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|-10.49|Standard Error of the Mean|13.89||0.4504|2-Sided|60.0|-22.18|1.21|||Mixed Models Analysis|||Month 54|
1723341|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|29.2|Standard Error of the Mean|10.54||0.0057|2-Sided|60.0|20.33|38.08|||Mixed Models Analysis|||Month 54|
1723342|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|-7.73|Standard Error of the Mean|13.47||0.5661|2-Sided|60.0|-19.07|3.61|||Mixed Models Analysis|||Month 48|
1723343|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|32.26|Standard Error of the Mean|10.45||0.0021|2-Sided|60.0|23.46|41.06|||Mixed Models Analysis|||Month 48|
1723344|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|8.42|Standard Error of the Mean|12.9||0.5143|2-Sided|60.0|-2.45|19.28|||Mixed Models Analysis|||Month 42|
1723345|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|19.93|Standard Error of the Mean|10.19||0.0508|2-Sided|60.0|11.35|28.51|||Mixed Models Analysis|||Month 42|
1723346|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|-5.65|Standard Error of the Mean|12.07||0.6397|2-Sided|60.0|-15.81|4.51|||Mixed Models Analysis|||Month 36|
1723347|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|12.52|Standard Error of the Mean|9.72||0.1981|2-Sided|60.0|4.33|20.71|||Mixed Models Analysis|||Month 36|
1723348|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|8.74|Standard Error of the Mean|10.09||0.3866|2-Sided|60.0|0.24|17.24|||Mixed Models Analysis|||Month 30|
1723349|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|17.6|Standard Error of the Mean|9.13||0.0542|2-Sided|60.0|9.91|25.29|||Mixed Models Analysis|||Month 30|
1723350|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|-13.21|Standard Error of the Mean|8.95||0.1402|2-Sided|60.0|-20.75|-5.68|||Mixed Models Analysis|||Month 24|
1723351|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|13.52|Standard Error of the Mean|8.35||0.1057|2-Sided|60.0|6.49|20.55|||Mixed Models Analysis|||Month 24|
1723352|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|-7.01|Standard Error of the Mean|8.56||0.4131|2-Sided|60.0|-14.21|0.2|||Mixed Models Analysis|||Month 18|
1723353|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|12.16|Standard Error of the Mean|8.19||0.1377|2-Sided|60.0|5.27|19.05|||Mixed Models Analysis|||Month 18|
1723354|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|-2.87|Standard Error of the Mean|8.5||0.736|2-Sided|60.0|-10.03|4.29|||Mixed Models Analysis|||Month 15|
1723355|NCT00658359|3172926|Superiority or Other||Mean Difference (Final Values)|14.35|Standard Error of the Mean|8.15||0.0786|2-Sided|60.0|7.49|21.22|||Mixed Models Analysis|||Month 15|
1723356|NCT00658359|3172928|Superiority or Other||Estimated rate difference|-3.12|Standard Error of the Mean|5.59||0.5772|2-Sided|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72|
1723357|NCT00658359|3172928|Superiority or Other||Estimated rate difference|5.91|Standard Error of the Mean|3.35||0.0774|2-Sided|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72|
1723358|NCT00658359|3172928|Superiority or Other||Estimated rate difference|-3.12|Standard Error of the Mean|5.59||0.5772|2-Sided|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723359|NCT00658359|3172928|Superiority or Other||Estimated rate difference|5.91|Standard Error of the Mean|3.35||0.0774|2-Sided|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723360|NCT00658359|3172928|Superiority or Other||Estimated rate difference|-3.12|Standard Error of the Mean|5.59||0.5772|2-Sided|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723361|NCT00658359|3172928|Superiority or Other||Estimated rate difference|5.91|Standard Error of the Mean|3.35||0.0774|2-Sided|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723362|NCT00658359|3172928|Superiority or Other||Estimated rate difference|-3.12|Standard Error of the Mean|5.59||0.5772|2-Sided|60.0|-7.82|1.59|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723363|NCT00658359|3172928|Superiority or Other||Estimated rate difference|5.91|Standard Error of the Mean|3.35||0.0774|2-Sided|60.0|3.1|8.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723364|NCT00658359|3172928|Superiority or Other||Estimated rate difference|-5.3|Standard Error of the Mean|5.18||0.3061|2-Sided|60.0|-9.66|-0.94|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723365|NCT00658359|3172928|Superiority or Other||Estimated rate difference|3.73|Standard Error of the Mean|2.62||0.1545|2-Sided|60.0|1.52|5.93|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723366|NCT00658359|3172928|Superiority or Other||Estimated rate difference|-5.3|Standard Error of the Mean|5.18||0.3061|2-Sided|60.0|-9.66|-0.94|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723367|NCT00658359|3172928|Superiority or Other||Estimated rate difference|3.73|Standard Error of the Mean|2.62||0.1545|2-Sided|60.0|1.52|5.93|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723368|NCT00658359|3172928|Superiority or Other||Estimated rate difference|-7.44|Standard Error of the Mean|4.74||0.1164|2-Sided|60.0|-11.43|-3.45|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723597|NCT00657020|3173020|Superiority or Other|||||||0.5421|||||||ANOVA|||Region of interest is right visual cortex.|
1723369|NCT00658359|3172928|Superiority or Other||Estimated rate difference|1.59|Standard Error of the Mean|1.57||0.3134|2-Sided|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723370|NCT00658359|3172928|Superiority or Other||Estimated rate difference|-4.19|Standard Error of the Mean|3.61||0.2447|2-Sided|60.0|-7.23|-1.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723371|NCT00658359|3172928|Superiority or Other||Estimated rate difference|1.59|Standard Error of the Mean|1.57||0.3134|2-Sided|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723372|NCT00658359|3172928|Superiority or Other||Estimated rate difference|-4.19|Standard Error of the Mean|3.61||0.2447|2-Sided|60.0|-7.23|-1.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24|
1723373|NCT00658359|3172928|Superiority or Other||Estimated rate difference|1.59|Standard Error of the Mean|1.57||0.3134|2-Sided|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24|
1723374|NCT00658359|3172928|Superiority or Other||Estimated rate difference|-0.26|Standard Error of the Mean|2.42||0.9129|2-Sided|60.0|-2.3|1.77|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18|
1723375|NCT00658359|3172928|Superiority or Other||Estimated rate difference|1.59|Standard Error of the Mean|1.57||0.3134|2-Sided|60.0|0.26|2.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18|
1723376|NCT00658359|3172928|Superiority or Other||Estimated rate difference|-1.85|Standard Error of the Mean|1.83||0.3128|2-Sided|60.0|-3.4|-0.31|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15|
1723377|NCT00658359|3172929|Superiority or Other||Estimated rate difference|3.52|Standard Error of the Mean|2.44||0.1503|2-Sided|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72|
1723378|NCT00658359|3172929|Superiority or Other||Estimated rate difference|3.52|Standard Error of the Mean|2.44||0.1503|2-Sided|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723379|NCT00658359|3172929|Superiority or Other||Estimated rate difference|3.52|Standard Error of the Mean|2.44||0.1503|2-Sided|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723380|NCT00658359|3172929|Superiority or Other||Estimated rate difference|3.52|Standard Error of the Mean|2.44||0.1503|2-Sided|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723381|NCT00658359|3172929|Superiority or Other||Estimated rate difference|3.52|Standard Error of the Mean|2.44||0.1503|2-Sided|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723382|NCT00658359|3172929|Superiority or Other||Estimated rate difference|3.52|Standard Error of the Mean|2.44||0.1503|2-Sided|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723383|NCT00658359|3172929|Superiority or Other||Estimated rate difference|3.52|Standard Error of the Mean|2.44||0.1503|2-Sided|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723384|NCT00658359|3172929|Superiority or Other||Estimated rate difference|3.52|Standard Error of the Mean|2.44||0.1503|2-Sided|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723385|NCT00658359|3172929|Superiority or Other||Estimated rate difference|3.52|Standard Error of the Mean|2.44||0.1503|2-Sided|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723386|NCT00658359|3172929|Superiority or Other||Estimated rate difference|3.52|Standard Error of the Mean|2.44||0.1503|2-Sided|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723387|NCT00658359|3172929|Superiority or Other||Estimated rate difference|3.52|Standard Error of the Mean|2.44||0.1503|2-Sided|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723388|NCT00658359|3172929|Superiority or Other||Estimated rate difference|3.52|Standard Error of the Mean|2.44||0.1503|2-Sided|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723389|NCT00658359|3172929|Superiority or Other||Estimated rate difference|3.52|Standard Error of the Mean|2.44||0.1503|2-Sided|60.0|1.46|5.57|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723390|NCT00658359|3172929|Superiority or Other||Estimated rate difference|1.69|Standard Error of the Mean|1.68||0.3132|2-Sided|60.0|0.28|3.11|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723391|NCT00658359|3172929|Superiority or Other||Estimated rate difference|1.69|Standard Error of the Mean|1.68||0.3132|2-Sided|60.0|0.28|3.11|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723392|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-4.51|Standard Error of the Mean|6.24||0.4692|2-Sided|60.0|-9.76|0.73|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12|
1723393|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-2.29|Standard Error of the Mean|6.31||0.7166|2-Sided|60.0|-7.61|3.02|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12|
1723394|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-6.03|Standard Error of the Mean|8.16||0.4604|2-Sided|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72|
1723395|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-12.44|Standard Error of the Mean|7.35||0.0905|2-Sided|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72|
1723598|NCT00657020|3173020|Superiority or Other|||||||0.7554|||||||ANOVA|||Region of interest is right visual cortex.|
1726665|NCT00594568|3181043|Superiority or Other|||||||0.172|||||||Mixed Models Analysis||||
1723396|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-6.03|Standard Error of the Mean|8.16||0.4604|2-Sided|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723397|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-12.44|Standard Error of the Mean|7.35||0.0905|2-Sided|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723398|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-6.03|Standard Error of the Mean|8.16||0.4604|2-Sided|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723399|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-12.44|Standard Error of the Mean|7.35||0.0905|2-Sided|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723400|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-6.03|Standard Error of the Mean|8.16||0.4604|2-Sided|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723401|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-12.44|Standard Error of the Mean|7.35||0.0905|2-Sided|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723402|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-6.03|Standard Error of the Mean|8.16||0.4604|2-Sided|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723403|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-12.44|Standard Error of the Mean|7.35||0.0905|2-Sided|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723404|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-6.03|Standard Error of the Mean|8.16||0.4604|2-Sided|60.0|-12.9|0.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723405|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-12.44|Standard Error of the Mean|7.35||0.0905|2-Sided|60.0|-18.62|-6.25|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723406|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-3.89|Standard Error of the Mean|8.0||0.6263|2-Sided|60.0|-10.62|2.84|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723407|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-10.3|Standard Error of the Mean|7.16||0.1501|2-Sided|60.0|-16.33|-4.28|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723408|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-2.16|Standard Error of the Mean|7.89||0.7846|2-Sided|60.0|-8.8|4.48|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723409|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-8.57|Standard Error of the Mean|7.04||0.2238|2-Sided|60.0|-14.5|-2.64|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723410|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-4.96|Standard Error of the Mean|7.52||0.5093|2-Sided|60.0|-11.29|1.37|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24|
1723411|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-8.57|Standard Error of the Mean|7.04||0.2238|2-Sided|60.0|-14.5|-2.64|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24|
1723412|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-5.24|Standard Error of the Mean|7.25||0.4696|2-Sided|60.0|-11.34|0.86|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18|
1723413|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-8.57|Standard Error of the Mean|6.79||0.2064|2-Sided|60.0|-14.28|-2.86|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18|
1723414|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-3.65|Standard Error of the Mean|7.14||0.6097|2-Sided|60.0|-9.66|2.37|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15|
1723415|NCT00658359|3172930|Superiority or Other||Estimated rate difference|-6.98|Standard Error of the Mean|6.67||0.2957|2-Sided|60.0|-12.6|-1.36|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15|
1723416|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-0.69|Standard Error of the Mean|4.34||0.873|2-Sided|60.0|-4.35|2.96|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 12|
1723417|NCT00658359|3172931|Superiority or Other||Mean Difference (Final Values)|3.75|Standard Error of the Mean|4.91||0.4455|2-Sided|60.0|-0.39|7.89|||Wald Test|||Month 12|
1723418|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-2.3|Standard Error of the Mean|7.87||0.7704|2-Sided|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72|
1723419|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-0.44|Standard Error of the Mean|7.83||0.9551|2-Sided|60.0|-7.03|6.15|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 72|
1723420|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-2.3|Standard Error of the Mean|7.87||0.7704|2-Sided|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723421|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-4.4|Standard Error of the Mean|7.51||0.5574|2-Sided|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723422|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-2.3|Standard Error of the Mean|7.87||0.7704|2-Sided|60.0|-8.92|4.33|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723423|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-4.4|Standard Error of the Mean|7.51||0.5574|2-Sided|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723424|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-4.56|Standard Error of the Mean|7.65||0.5515|2-Sided|60.0|-10.99|1.88|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723425|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-4.4|Standard Error of the Mean|7.51||0.5574|2-Sided|60.0|-10.72|1.91|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723426|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-2.73|Standard Error of the Mean|7.52||0.7168|2-Sided|60.0|-9.06|3.6|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723427|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-2.58|Standard Error of the Mean|7.38||0.7267|2-Sided|60.0|-8.78|3.63|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723428|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-0.9|Standard Error of the Mean|7.38||0.9029|2-Sided|60.0|-7.11|5.31|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723429|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-4.4|Standard Error of the Mean|6.91||0.5244|2-Sided|60.0|-10.22|1.42|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723430|NCT00658359|3172931|Superiority or Other||Estimated rate difference|0.77|Standard Error of the Mean|6.87||0.9106|2-Sided|60.0|-5.01|6.56|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723431|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-0.74|Standard Error of the Mean|6.57||0.9099|2-Sided|60.0|-6.28|4.79|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723432|NCT00658359|3172931|Superiority or Other||Estimated rate difference|2.18|Standard Error of the Mean|6.39||0.7336|2-Sided|60.0|-3.2|7.55|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723433|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-2.64|Standard Error of the Mean|5.7||0.6432|2-Sided|60.0|-7.44|2.16|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723434|NCT00658359|3172931|Superiority or Other||Estimated rate difference|3.82|Standard Error of the Mean|6.22||0.539|2-Sided|60.0|-1.41|9.06|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24|
1723435|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-0.99|Standard Error of the Mean|5.51||0.8572|2-Sided|60.0|-5.63|3.65|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 24|
1723436|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-1.73|Standard Error of the Mean|5.56||0.7555|2-Sided|60.0|-6.41|2.95|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18|
1723437|NCT00658359|3172931|Superiority or Other||Estimated rate difference|-0.99|Standard Error of the Mean|5.51||0.8572|2-Sided|60.0|-5.63|3.65|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 18|
1723438|NCT00658359|3172931|Superiority or Other||Estimated rate difference|1.45|Standard Error of the Mean|5.18||0.7799|2-Sided|60.0|-2.91|5.8|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15|
1723439|NCT00658359|3172931|Superiority or Other||Estimated rate difference|2.19|Standard Error of the Mean|5.12||0.6694|2-Sided|60.0|-2.12|6.5|||Wald Test||Standard error of the mean refers to standard error of the estimated rate difference|Month 15|
1723440|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-4.8|Standard Error of the Mean|5.87||0.4131|2-Sided|60.0|-9.74|0.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12|
1723441|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-7.4|Standard Error of the Mean|5.41||0.1715|2-Sided|60.0|-11.95|-2.84|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12|
1723442|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-18.58|Standard Error of the Mean|7.32||0.0111|2-Sided|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72|
1723443|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-18.02|Standard Error of the Mean|7.24||0.0128|2-Sided|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72|
1723444|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-18.58|Standard Error of the Mean|7.32||0.0111|2-Sided|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723445|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-18.02|Standard Error of the Mean|7.24||0.0128|2-Sided|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723446|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-18.58|Standard Error of the Mean|7.32||0.0111|2-Sided|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723447|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-18.02|Standard Error of the Mean|7.24||0.0128|2-Sided|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723448|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-18.58|Standard Error of the Mean|7.32||0.0111|2-Sided|60.0|-24.74|-12.42|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723449|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-18.02|Standard Error of the Mean|7.24||0.0128|2-Sided|60.0|-24.12|-11.93|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723450|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-16.45|Standard Error of the Mean|7.15||0.0214|2-Sided|60.0|-22.46|-10.43|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723451|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-15.89|Standard Error of the Mean|7.07||0.0246|2-Sided|60.0|-21.84|-9.94|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723452|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-16.45|Standard Error of the Mean|7.15||0.0214|2-Sided|60.0|-22.46|-10.43|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723453|NCT00658359|3172932|Superiority or Other||Estimated rate differences|-15.89|Standard Error of the Mean|7.07||0.0246|2-Sided|60.0|-21.84|-9.94|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723454|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-12.83|Standard Error of the Mean|6.9||0.0629|2-Sided|60.0|-18.63|-7.02|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723455|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-12.27|Standard Error of the Mean|6.81||0.0718|2-Sided|60.0|-18.0|-6.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723456|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-9.37|Standard Error of the Mean|6.63||0.158|2-Sided|60.0|-14.95|-3.78|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723457|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-8.81|Standard Error of the Mean|6.55||0.1785|2-Sided|60.0|-14.32|-3.3|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723458|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-7.64|Standard Error of the Mean|6.49||0.239|2-Sided|60.0|-13.1|-2.18|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24|
1723459|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-7.08|Standard Error of the Mean|6.4||0.2685|2-Sided|60.0|-12.47|-1.7|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24|
1723460|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-7.64|Standard Error of the Mean|6.49||0.239|2-Sided|60.0|-13.1|-2.18|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18|
1723461|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-8.75|Standard Error of the Mean|6.23||0.1601|2-Sided|60.0|-13.99|-3.51|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18|
1723462|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-6.08|Standard Error of the Mean|6.37||0.3398|2-Sided|60.0|-11.43|-0.72|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15|
1723463|NCT00658359|3172932|Superiority or Other||Estimated rate difference|-10.52|Standard Error of the Mean|5.71||0.0654|2-Sided|60.0|-15.33|-5.71|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15|
1723464|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-0.69|Standard Error of the Mean|4.34||0.873|2-Sided|60.0|-4.35|2.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12|
1723465|NCT00658359|3172933|Superiority or Other||Estimated rate difference|3.75|Standard Error of the Mean|4.91||0.4455|2-Sided|60.0|-0.39|7.89|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12|
1723466|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-5.94|Standard Error of the Mean|5.7||0.2972|2-Sided|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72|
1723467|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-3.34|Standard Error of the Mean|5.89||0.5704|2-Sided|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72|
1723468|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-5.94|Standard Error of the Mean|5.7||0.2972|2-Sided|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723469|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-3.34|Standard Error of the Mean|5.89||0.5704|2-Sided|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723470|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-5.94|Standard Error of the Mean|5.7||0.2972|2-Sided|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723471|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-3.34|Standard Error of the Mean|5.89||0.5704|2-Sided|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723472|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-5.94|Standard Error of the Mean|5.7||0.2972|2-Sided|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723473|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-3.34|Standard Error of the Mean|5.89||0.5704|2-Sided|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723474|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-5.94|Standard Error of the Mean|5.7||0.2972|2-Sided|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723475|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-3.34|Standard Error of the Mean|5.89||0.5704|2-Sided|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723599|NCT00657020|3173020|Superiority or Other|||||||0.8318|||||||ANOVA|||Region of interest is right superior occipital cortex.|
1723476|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-5.94|Standard Error of the Mean|5.7||0.2972|2-Sided|60.0|-10.73|-1.14|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723477|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-3.34|Standard Error of the Mean|5.89||0.5704|2-Sided|60.0|-8.31|1.62|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723478|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-3.77|Standard Error of the Mean|5.35||0.4809|2-Sided|60.0|-8.27|0.73|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723479|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-1.18|Standard Error of the Mean|5.56||0.8322|2-Sided|60.0|-5.86|3.5|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723480|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-1.99|Standard Error of the Mean|5.1||0.696|2-Sided|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723481|NCT00658359|3172933|Superiority or Other||Estimated rate difference|0.6|Standard Error of the Mean|5.32||0.9106|2-Sided|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723482|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-1.99|Standard Error of the Mean|5.1||0.696|2-Sided|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24|
1723483|NCT00658359|3172933|Superiority or Other||Estimated rate difference|0.6|Standard Error of the Mean|5.32||0.9106|2-Sided|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24|
1723484|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-1.99|Standard Error of the Mean|5.1||0.696|2-Sided|60.0|-6.29|2.3|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18|
1723485|NCT00658359|3172933|Superiority or Other||Estimated rate difference|0.6|Standard Error of the Mean|5.32||0.9106|2-Sided|60.0|-3.88|5.08|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18|
1723486|NCT00658359|3172933|Superiority or Other||Estimated rate difference|-0.41|Standard Error of the Mean|4.89||0.934|2-Sided|60.0|-4.52|3.71|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15|
1723487|NCT00658359|3172933|Superiority or Other||Estimated rate difference|2.19|Standard Error of the Mean|5.12||0.6694|2-Sided|60.0|-2.12|6.5|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15|
1723488|NCT00658359|3172935|Superiority or Other||Mean Difference (Final Values)|8.23|Standard Error of the Mean|6.32||0.1958|2-Sided|60.0|2.89|13.58|||Mixed Models Analysis||Tofacitinib MI minus CsA||
1723489|NCT00658359|3172935|Superiority or Other||Mean Difference (Final Values)|9.23|Standard Error of the Mean|5.04||0.0699|2-Sided|60.0|4.97|13.49|||Mixed Models Analysis||Tofacitinib LI minus CsA||
1723490|NCT00658359|3172936|Superiority or Other||Estimated rate difference|3.9|Standard Error of the Mean|6.2||0.529|2-Sided|95.0|-8.3|16.1|||Chi-squared||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference||
1723491|NCT00658359|3172936|Superiority or Other||Estimated rate difference|2.4|Standard Error of the Mean|5.9||0.683|2-Sided|95.0|-9.1|13.9|||Chi-squared||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference||
1723492|NCT00658359|3172937|Superiority or Other||Estimated rate difference|-0.98|Standard Error of the Mean|3.69||0.7895|2-Sided|60.0|-4.09|2.12|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12|
1723493|NCT00658359|3172937|Superiority or Other||Estimated rate difference|3.65|Standard Error of the Mean|4.44||0.4116|2-Sided|60.0|-0.09|7.38|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 12|
1723494|NCT00658359|3172937|Superiority or Other||Estimated rate difference|21.08|Standard Error of the Mean|11.84||0.0749|2-Sided|60.0|11.12|31.04|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72|
1723495|NCT00658359|3172937|Superiority or Other||Estimated rate difference|18.17|Standard Error of the Mean|9.56||0.0574|2-Sided|60.0|10.12|26.22|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 72|
1723496|NCT00658359|3172937|Superiority or Other||Estimated rate difference|15.83|Standard Error of the Mean|9.53||0.0966|2-Sided|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723497|NCT00658359|3172937|Superiority or Other||Estimated rate difference|17.07|Standard Error of the Mean|8.74||0.0507|2-Sided|60.0|9.72|24.42|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 66|
1723498|NCT00658359|3172937|Superiority or Other||Estimated rate difference|15.83|Standard Error of the Mean|9.53||0.0966|2-Sided|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723499|NCT00658359|3172937|Superiority or Other||Estimated rate difference|17.07|Standard Error of the Mean|8.74||0.0507|2-Sided|60.0|9.72|24.42|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 60|
1723500|NCT00658359|3172937|Superiority or Other||Estimated rate difference|15.83|Standard Error of the Mean|9.53||0.0966|2-Sided|60.0|7.81|23.85|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723501|NCT00658359|3172937|Superiority or Other||Estimated rate difference|14.03|Standard Error of the Mean|8.45||0.0968|2-Sided|60.0|6.92|21.14|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 54|
1723502|NCT00658359|3172937|Superiority or Other||Estimated rate difference|18.08|Standard Error of the Mean|9.34||0.0528|2-Sided|60.0|10.22|25.94|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723503|NCT00658359|3172937|Superiority or Other||Estimated rate difference|11.02|Standard Error of the Mean|7.74||0.1545|2-Sided|60.0|4.51|17.54|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 48|
1723504|NCT00658359|3172937|Superiority or Other||Estimated rate difference|20.27|Standard Error of the Mean|9.14||0.0266|2-Sided|60.0|12.58|27.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723505|NCT00658359|3172937|Superiority or Other||Estimated rate difference|13.21|Standard Error of the Mean|7.5||0.0783|2-Sided|60.0|6.9|19.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 42|
1723506|NCT00658359|3172937|Superiority or Other||Estimated rate difference|20.27|Standard Error of the Mean|9.14||0.0266|2-Sided|60.0|12.58|27.96|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723507|NCT00658359|3172937|Superiority or Other||Estimated rate difference|13.21|Standard Error of the Mean|7.5||0.0783|2-Sided|60.0|6.9|19.53|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 36|
1723508|NCT00658359|3172937|Superiority or Other||Estimated rate difference|16.66|Standard Error of the Mean|7.75||0.0316|2-Sided|60.0|10.14|23.19|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723509|NCT00658359|3172937|Superiority or Other||Estimated rate difference|12.62|Standard Error of the Mean|7.09||0.075|2-Sided|60.0|6.66|18.59|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 30|
1723510|NCT00658359|3172937|Superiority or Other||Estimated rate difference|13.47|Standard Error of the Mean|7.1||0.058|2-Sided|60.0|7.49|19.45|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24|
1723511|NCT00658359|3172937|Superiority or Other||Estimated rate difference|7.31|Standard Error of the Mean|6.36||0.2499|2-Sided|60.0|1.96|12.66|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 24|
1723512|NCT00658359|3172937|Superiority or Other||Estimated rate difference|11.06|Standard Error of the Mean|6.61||0.0942|2-Sided|60.0|5.5|16.62|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18|
1723513|NCT00658359|3172937|Superiority or Other||Estimated rate difference|3.93|Standard Error of the Mean|5.71||0.4912|2-Sided|60.0|-0.87|8.74|||Wald Test||Tofacitinib LI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 18|
1723514|NCT00658359|3172937|Superiority or Other||Estimated rate difference|10.71|Standard Error of the Mean|6.26||0.0873|2-Sided|60.0|5.44|15.98|||Wald Test||Tofacitinib MI minus CsA Standard error of the mean refers to standard error of the estimated rate difference|Month 15|
1723515|NCT00658359|3172937|Superiority or Other||Estimated rate difference|2.19|Standard Error of the Mean|5.12||0.6694|2-Sided|60.0|-2.12|6.5|||Wald Test||Tofacitinib LI minus CsA. Standard error of the mean refers to standard error of the estimated rate difference|Month 15|
1723516|NCT00658138|3172950|Non-Inferiority or Equivalence|No power calculation done - pilot study|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis is adhesives are not different in clinical performance at one year|
1723517|NCT00658138|3172950|Non-Inferiority or Equivalence|No power calculation done - pilot study|Mean Difference (Final Values)|0.05|||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Hypothesis was no difference between adhesives tested at one year. Restorations were scored using USPHS subjective clinical criteria.|
1723518|NCT00657709|3172958|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-2.0|||||2-Sided|95.0|-7.0|2.0||||||Immunogenicity of the PT antigen of DTPa-HBV-IPV vaccine given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.|
1723519|NCT00657709|3172958|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-9.0|||||2-Sided|95.0|-16.0|-3.0||||||Immunogenicity of the Pertactin antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.|
1723520|NCT00657709|3172958|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-3.0|||||2-Sided|95.0|-9.0|4.0||||||Immunogenicity of the FHA antigen of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects was greater than -10%.|
1723521|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-3.0|||||2-Sided|95.0|-8.0|2.0||||||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 23F antigen, greater than -10%.|
1723522|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||2-Sided|95.0|-3.0|4.0||||||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was for PnC 19F antigen, greater than -10%.|
1723523|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||2-Sided|95.0|-3.0|1.0||||||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 18C antigen greater than -10%.|
1723524|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||2-Sided|95.0|-4.0|3.0||||||Immunogenicity of the 7 components of PCV7 vaccine when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC14 antigen, greater than -10%.|
1723525|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||2-Sided|95.0|-2.0|1.0||||||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa_HBV-IPV vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 9V, greater than -10%.|
1723526|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|2.0|||||2-Sided|95.0|-4.0|8.0||||||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL, was, for PnC 6B antigen greater than -10%.|
1723527|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-2.0|||||2-Sided|95.0|-4.0|0.0||||||Immunogenicity of the 7 components of PCV7 when given concomitantly with rMenB and DTPa-HBV-IPV at 2, 4 and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two-sided 95% confidence interval for the difference in the percentage of subjects with antibody response greater than the cutoff of ≥0.35 μg/mL was, for the pneumococcal antigen PnC4.|
1723528|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|vaccine group difference|0.0|||||2-Sided|95.0|-7.0|7.0||||||Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥1.0 μg/mL was greater than -10%.|
1723529|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-1.0|||||2-Sided|95.0|-3.0|1.0||||||Immunogenicity of the PRP-Hib component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferiority that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with Hib capsular polysaccharide (PRP) antibody response greater than the protective cutoff of ≥0.15 μg/mL was greater than -10%.|
1723530|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|percentage group difference|-2.0|||||2-Sided|95.0|-5.0|-1.0||||||Immunogenicity of the hepatitis B surface antigen component of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 vaccine at 2, 4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT ≥10.0 mIU/ml was greater than -10%|
1723531|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||2-Sided|95.0|-4.0|2.0||||||Immunogenicity of the polio type 3 of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 at 2,4, and 6 months of age would be considered non-inferior to that of the routine vaccinations given alone, if the lower limit of the two sided 95% confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.|
1723532|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|vaccine group difference|-5.0|||||2-Sided|95.0|-11.0|-1.0||||||Immunogenicity of the polio type 2 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBVIPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.|
1723533|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-1.0|||||2-Sided|95.0|-5.0|2.0||||||Immunogenicity of the polio type 1 of Diphtheria-Tetanus-Acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-HBV-IPV) when given concomitantly with rMenB and Pneumococcal 7-valent conjugate vaccine (PCV7) at 2, 4, and 6 months of age would be considered non-inferior to that of the confidence interval for the difference in the percentage of subjects with NT titers ≥1:8 was greater than -10%.|
1723534|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-4.0|||||2-Sided|95.0|-9.0|1.0||||||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.|
1723600|NCT00657020|3173020|Superiority or Other|||||||0.8486|||||||ANOVA|||Region of interest is right superior occipital cortex.|
1726666|NCT00594568|3181043|Superiority or Other|||||||0.296|||||||Mixed Models Analysis||||
1723535|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||2-Sided|95.0|-2.0|2.0||||||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for Tetanus toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.|
1723536|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|-5.0|||||2-Sided|95.0|-12.0|1.0||||||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age, would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥1.0 IU/mL for that antigen.|
1723537|NCT00657709|3172959|Non-Inferiority or Equivalence|{PConcomitant Vaccine +rMenB+OMV NZ lot1+lot2+lot3 minus PConcomitant Vaccine}|Percentage group difference|0.0|||||2-Sided|95.0|-1.0|2.0||||||Immunogenicity of the routine infant vaccines, when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age,would be considered non-inferior to that of routine infant vaccines given alone, for diphtheria toxoids antigen, if the lower limit of the two-sided 95% CI for the difference in the percentage of subjects with antibody response greater than or equal to the cut-off level ≥0.1 IU/mL for that antigen.|
1723538|NCT00657709|3172960|Non-Inferiority or Equivalence|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.8|||||2-Sided|95.0|0.71|0.91||||||Immunogenicity of the pertussis components (PT) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.|
1723539|NCT00657709|3172960|Non-Inferiority or Equivalence|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.77|||||2-Sided|95.0|0.67|0.89||||||Immunogenicity of the pertussis component (Pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.|
1723540|NCT00657709|3172960|Non-Inferiority or Equivalence|GMCs (GMCrMenB+OMV NZ lot1+lot2+lot3+InfanrixHexa / GMCInfanrixHexa)|Geometric group difference|0.84|||||2-Sided|95.0|0.76|0.94||||||Immunogenicity of the pertussis components (FHA) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after the third vaccination is ≥0.67.|
1723541|NCT00657709|3172963|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided (5% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for NZ98/254 strain.|Percentage group difference|-4.0|||||2-Sided|95.0|-9.0|1.0||||||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third dose, were entirely within the interval [-10%, 10%].|
1723542|NCT00657709|3172963|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for NZ 98/254 strain.|Percentage group difference|-1.0|||||2-Sided|95.0|-6.0|4.0||||||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1 month after the third dise, were entirely within the interval [-10%, 10%].|
1723543|NCT00657709|3172963|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for NZ98/254 strain.|Percentage group difference|3.0|||||2-Sided|95.0|-2.0|8.0||||||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentages of subjects with hSBA titers ≥ 1:5 at 1 month after the third dose, were entirely within the interval [-10%, 10%].|
1723544|NCT00657709|3172963|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 5/99 strain.|Vaccines Group Differences|1.0|||||2-Sided|95.0|0.0|2.0||||||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval [-10%, 10%].|
1723545|NCT00657709|3172963|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 5/99 strain.|Vaccines Group Differences|1.0|||||2-Sided|95.0|0.0|2.0||||||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval [-10%, 10%].|
1723546|NCT00657709|3172963|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 5/99 strain.|Vaccines Group Differences|0.0|||||2-Sided|95.0|-1.0|1.0||||||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval [-10%, 10%].|
1723601|NCT00657020|3173020|Superiority or Other|||||||0.2612|||||||ANOVA|||Region of interest is right premotor cortex.|
1723547|NCT00657709|3172963|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|1.0|||||2-Sided|95.0|0.0|2.0||||||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval [-10%, 10%].|
1723548|NCT00657709|3172963|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|1.0|||||2-Sided|95.0|0.0|2.0||||||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at 1month after the third dose, were entirely within the interval [-10%, 10%].|
1723549|NCT00657709|3172963|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs of the differences in the percentages of subjects at one month following third vaccination was within this equivalence interval for each of the two comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 44/76-SL strain.|Vaccines Group Differences|0.0|||||2-Sided|95.0|-1.0|1.0||||||The three vaccine lots would be considered equivalent if for each of the three strains and each pair of vaccine lots, the 95% CIs of the differences in the percentage of subjects with hSBA titers ≥ 1:5 at one month after the third vaccination, were entirely within the interval [-10%, 10%].|
1723550|NCT00657709|3172965|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for for NZ98 /254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.92|||||2-Sided|95.0|0.78|1.08||||||"The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for NZ98~/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0)."|
1723551|NCT00657709|3172965|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.96||||||95.0|0.81|1.13||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).|
1723552|NCT00657709|3172965|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for for NZ98/254 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.04||||||95.0|0.88|1.23||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for NZ98/254 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).|
1723553|NCT00657709|3172965|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.12|||||2-Sided|95.0|1.0|1.26||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).|
1723554|NCT00657709|3172965|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.99|||||2-Sided|95.0|0.88|1.1||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).|
1723555|NCT00657709|3172965|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 5/99 strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.88|||||2-Sided|95.0|0.78|0.98||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 5/99 strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).|
1723556|NCT00657709|3172965|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot2 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.14|||||2-Sided|95.0|1.03|1.27||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot2 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).|
1723602|NCT00657020|3173020|Superiority or Other|||||||0.3755|||||||ANOVA|||Region of interest is right premotor cortex.|
1723603|NCT00657020|3173020|Superiority or Other|||||||0.9781|||||||ANOVA|||Region of interest is right parietal cortex.|
1723604|NCT00657020|3173020|Superiority or Other|||||||0.5135|||||||ANOVA|||Region of interest is right parietal cortex.|
1723605|NCT00657020|3173020|Superiority or Other|||||||0.2205|||||||ANOVA|||Region of interest is left visual cortex.|
1723557|NCT00657709|3172965|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot3 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.02|||||2-Sided|95.0|0.93|1.13||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot3 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).|
1723558|NCT00657709|3172965|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following third vaccination was within this equivalence interval for each of the two co-primary comparisons, rMenB Lot1 and rMenB Lot2 would be equivalent for 44/76-SL strain with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.9|||||2-Sided|95.0|0.81|0.99||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing rMenB Lot1 to rMenB Lot2 for 44/76-SL strain at one month after the third vaccination was contained within the equivalence interval (0.5, 2.0).|
1723559|NCT00657540|3172977|Superiority or Other|||||||0.2765|||||||Chi-squared|The proportion of subjects with decreased pain at any time point between treatment groups using a one-sided test at the 0.025 level of significance.|||
1723560|NCT00657540|3172978|Superiority or Other|||||||0.8213|||||||Chi-squared|The proportion of subjects with at least one drug-related adverse event by treatment groups using a two-sided test at the 0.05 level of significance.|||
1723561|NCT00657540|3172979|Superiority or Other|||||||0.2302|||||||Chi-squared|Chi-squared tests at the 0.025 level of significance were used to test for a difference in proportions between the treatment groups.|||
1723562|NCT00657540|3172980|Superiority or Other|||||||0.0185|||||||Chi-squared|The proportion of treatment failures was compared between groups using a one-sided test at the 0.025 level of significance.|||
1723563|NCT00657358|3172988|Superiority or Other||R^2 (adj)|0.477|||<|0.001|2-Sided|95.0|||||Regression, Linear|DF=2 DFDEN=371.8, F-ratio=10.66|||
1723564|NCT00657150|3173000|Superiority or Other||Absolute Difference (Percentage)|1.4||||0.2626|2-Sided|95.0|-1.1|3.9|||Normal approximation|Normal approximation of independent binomial distribution||Absolute difference versus Enoxaparin for the category any bleeding events|
1723565|NCT00657150|3173000|Superiority or Other||Absolute Difference (Percentage)|0.8||||0.3305|2-Sided|95.0|-0.8|2.3|||Normal approximation|Normal approximation of independent binomial distribution||Absolute difference versus Enoxaparin for the category major and clinically relevant bleeding events|
1723566|NCT00657150|3173000|Superiority or Other|||||||0.4022|||||||Fisher Exact|||Comparison versus Enoxaparin for the category major bleeding events|
1723567|NCT00657150|3173001|Superiority or Other|||||||0.687|||||||Fisher Exact|||Comparison versus Enoxaparin|
1723568|NCT00657150|3173002|Superiority or Other|||||||0.4977|||||||Fisher Exact|||Comparison versus Enoxaparin|
1723569|NCT00657150|3173003|Superiority or Other|||||||0.6231|||||||Fisher Exact|||Comparison versus Enoxaparin|
1723570|NCT00657150|3173004|Superiority or Other|||||||0.0612|||||||Fisher Exact|||Comparison versus Enoxaparin|
1723571|NCT00657150|3173005|Superiority or Other||Risk Difference (Percentage)|-0.96||||0.4839|2-Sided|95.0|-3.65|1.73|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1723572|NCT00657150|3173006|Superiority or Other||Risk Difference (Percentage)|-1.79||||0.0358||95.0|-3.47|-0.12|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1723573|NCT00657150|3173007|Superiority or Other||Risk Difference (RD)|-1.91||||0.029||95.0|-3.64|-0.19|||Normal approximation|Normal approximation of independent binomial distribution without stratification|||
1723574|NCT00657150|3173008|Non-Inferiority or Equivalence|Non-inferiority Analysis with NI margin 7.7%|Risk Difference (Percentage)|-1.08|||<|0.0001||95.0|-3.79|1.64||Superiority p−value = 0.4367|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1723575|NCT00657046|3173009|Superiority or Other|||||||0.008|||||||Fisher Exact||||
1723576|NCT00657046|3173009|Superiority or Other|||||||0.082|||||||Fisher Exact||||
1723577|NCT00657046|3173010|Superiority or Other|||||||0.022|||||||ANCOVA|GLM model with baseline as a covariate.|||
1723578|NCT00657046|3173010|Superiority or Other|||||||0.025|||||||ANCOVA|GLM model with baseline as a covariate|||
1723579|NCT00657046|3173011|Superiority or Other|||||||0.03|||||||ANCOVA|GLM model with baseline as a covariate|||
1723580|NCT00657046|3173011|Superiority or Other|||||||0.004|||||||ANCOVA|GLM model with baseline as a covariate|||
1723581|NCT00657046|3173012|Superiority or Other|||||||0.408|||||||ANCOVA|GLM model with baseline as a covariate|||
1723582|NCT00657046|3173012|Superiority or Other|||||||0.319|||||||ANCOVA|GLM model with baseline as a covariate|||
1723583|NCT00657046|3173013|Superiority or Other|||||||0.903|||||||ANCOVA|GLM model with baseline as a covariate|||
1723584|NCT00657046|3173013|Superiority or Other|||||||0.376|||||||ANCOVA|GLM model with baseline as a covariate|||
1723585|NCT00657046|3173014|Superiority or Other|||||||0.94|||||||ANCOVA|GLM model with baseline as a covariate|||
1723586|NCT00657046|3173014|Superiority or Other|||||||0.4602|||||||ANCOVA|GLM model with baseline as a covariate|||
1723587|NCT00657046|3173015|Superiority or Other|||||||0.607|||||||ANCOVA|GLM model with baseline as a covariate.|||
1723588|NCT00657046|3173015|Superiority or Other|||||||0.712|||||||ANCOVA|GLM model with baseline as a covariate.|||
1723589|NCT00657046|3173016|Superiority or Other|||||||0.23|||||||ANCOVA|GLM model with baseline as a covariate.|||
1723590|NCT00657046|3173016|Superiority or Other|||||||0.212|||||||ANCOVA|GLM model with baseline as a covariate.|||
1723591|NCT00657046|3173017|Superiority or Other|||||||0.807|||||||ANCOVA|GLM model with baseline as a covariate.|||
1723592|NCT00657046|3173017|Superiority or Other|||||||0.693|||||||ANCOVA|GLM model with baseline as a covariate.|||
1723593|NCT00657020|3173018|Superiority or Other|||||||0.18|||||||ANOVA|||Null hypothesis considered the treatments in comparison to be equal.|
1723607|NCT00657020|3173020|Superiority or Other|||||||0.7959|||||||ANOVA|||Region of interest is left superior occipital cortex.|
1723608|NCT00657020|3173020|Superiority or Other|||||||0.7511|||||||ANOVA|||Region of interest is left superior occipital cortex.|
1723609|NCT00657020|3173020|Superiority or Other|||||||0.6716|||||||ANOVA|||Region of interest is left parietal cortex.|
1723610|NCT00657020|3173020|Superiority or Other|||||||0.5544|||||||ANOVA|||Region of interest is left parietal cortex.|
1723611|NCT00657020|3173021|Superiority or Other|||||||0.0106|||||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.|
1723612|NCT00657020|3173021|Superiority or Other|||||||0.6261|||||||ANOVA|||Null hypothesis considered treatments in comparison to be equal.|
1723613|NCT00657020|3173022|Superiority or Other|||||||0.1811|||||||ANOVA|||Null hypothesis considered the response time of treatments in comparison to be equal.|
1723614|NCT00657020|3173022|Superiority or Other|||||||0.4535|||||||ANOVA|||Null hypothesis considered the response time of treatments in comparison to be equal.|
1723615|NCT00657020|3173023|Superiority or Other|||||||0.1931|||||||ANOVA|||Region of interest is right visual cortex|
1723616|NCT00657020|3173023|Superiority or Other|||||||0.2485|||||||ANOVA|||Region of interest is right visual cortex|
1723617|NCT00657020|3173023|Superiority or Other|||||||0.4604|||||||ANOVA|||Region of interest is right thalamus|
1723618|NCT00657020|3173023|Superiority or Other|||||||0.4622|||||||ANOVA|||Region of interest is right thalamus|
1723619|NCT00657020|3173023|Superiority or Other|||||||0.3982|||||||ANOVA|||Region of interest is right premotor cortex|
1723620|NCT00657020|3173023|Superiority or Other|||||||0.4755|||||||ANOVA|||Region of interest is right premotor cortex|
1723621|NCT00657020|3173023|Superiority or Other|||||||0.7711|||||||ANOVA|||Region of interest is right parietal cortex|
1723622|NCT00657020|3173023|Superiority or Other|||||||0.9343|||||||ANOVA|||Region of interest is right parietal cortex|
1723623|NCT00657020|3173023|Superiority or Other|||||||0.4482|||||||ANOVA|||Region of interest is right dorsolateral pre-frontal cortex|
1723624|NCT00657020|3173023|Superiority or Other|||||||0.9494|||||||ANOVA|||Region of interest is right dorsolateral pre-frontal cortex|
1723625|NCT00657020|3173023|Superiority or Other|||||||0.7895|||||||ANOVA|||Region of interest is right dorsal anterior cingulate cortex|
1723626|NCT00657020|3173023|Superiority or Other|||||||0.7551|||||||ANOVA|||Region of interest is right dorsal anterior cingulate cortex|
1723627|NCT00657020|3173023|Superiority or Other|||||||0.9588|||||||ANOVA|||Region of interest is right anterior insula|
1723628|NCT00657020|3173023|Superiority or Other|||||||0.5318|||||||ANOVA|||Region of interest is right anterior insula|
1723629|NCT00657020|3173023|Superiority or Other|||||||0.183|||||||ANOVA|||Region of interest is left visual cortex|
1723630|NCT00657020|3173023|Superiority or Other|||||||0.9049|||||||ANOVA|||Region of interest is left visual cortex|
1723631|NCT00657020|3173023|Superiority or Other|||||||0.7475|||||||ANOVA|||Region of interest is left thalamus|
1723632|NCT00657020|3173023|Superiority or Other|||||||0.642|||||||ANOVA|||Region of interest is left thalamus|
1723633|NCT00657020|3173023|Superiority or Other|||||||0.8195|||||||ANOVA|||Region of interest is left substantia nigra/ventral tegmental area|
1723634|NCT00657020|3173023|Superiority or Other|||||||0.1837|||||||ANOVA|||Region of interest is left substantia nigra/ventral tegmental area|
1723635|NCT00657020|3173023|Superiority or Other|||||||0.2065|||||||ANOVA|||Region of interest is left premotor cortex|
1723636|NCT00657020|3173023|Superiority or Other|||||||0.9879|||||||ANOVA|||Region of interest is left premotor cortex|
1723637|NCT00657020|3173023|Superiority or Other|||||||0.0611|||||||ANOVA|||Region of interest is left parietal cortex|
1723638|NCT00657020|3173023|Superiority or Other|||||||0.4228|||||||ANOVA|||Region of interest is left parietal cortex|
1723639|NCT00657020|3173023|Superiority or Other|||||||0.8511|||||||ANOVA|||Region of interest is left dorsolateral pre-frontal cortex|
1723640|NCT00657020|3173023|Superiority or Other|||||||0.7153|||||||ANOVA|||Region of interest is left dorsolateral pre-frontal cortex.|
1723641|NCT00657020|3173023|Superiority or Other|||||||0.0078|||||||ANOVA|||Region of interest is left dorsal anterior cingulate cortex.|
1723642|NCT00657020|3173023|Superiority or Other|||||||0.8295|||||||ANOVA|||Region of interest is left dorsal anterior cingulate cortex.|
1723643|NCT00657020|3173023|Superiority or Other|||||||0.6639|||||||ANOVA|||Region of interest is left anterior putamen.|
1723644|NCT00657020|3173023|Superiority or Other|||||||0.1192|||||||ANOVA|||Region of interest is left anterior putamen.|
1723645|NCT00657020|3173023|Superiority or Other|||||||0.345|||||||ANOVA|||Region of interest is left anterior insula.|
1723646|NCT00657020|3173023|Superiority or Other|||||||0.296|||||||ANOVA|||Region of Interest is left anterior insula.|
1723647|NCT00656669|3173057|Superiority or Other|||||||0.7963||||||a priori threshold of <0.05|t-test, 2 sided|This is a paired t-test to compare baseline IFP to IFP after completion of paxlitaxel+sunitinib treatment|||
1723648|NCT00656669|3173058|Superiority or Other|||||||0.0001|||||||t-test, 2 sided|This is a paired t-test to compare baseline IFP to IFP after completion of sunitinib monotherapy||From Taghian et al., we used a mean IFP of 6.5 at baseline and a standard deviation of 6.1. We would like to detect a 50% reduction of IFP (to 3.25 mmHg) with sunitinib monotherapy, so the effect size would be 3.25/6.1=0.53. A two-sided paired t-test has 80% power to detect an effect size of .53 and level of significance .05 when the sample size is 30 patients.|
1723649|NCT00656513|3173068|Superiority|||||||0.14||||||Two-sided test, significance level 0.05|t-test, 2 sided||||
1723650|NCT00656513|3173069|Superiority|||||||0.58||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723651|NCT00656513|3173069|Superiority|||||||0.56||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723652|NCT00656513|3173069|Superiority|||||||0.99||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723653|NCT00656513|3173069|Superiority|||||||0.54||||||4-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723654|NCT00656513|3173070|Superiority|||||||0.89||||||15-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723655|NCT00656513|3173070|Superiority|||||||0.28||||||9-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723656|NCT00656513|3173070|Superiority|||||||0.83||||||6-months; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723657|NCT00656513|3173070|Superiority|||||||0.97||||||4-month score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723658|NCT00656513|3173071|Superiority|||||||0.68||||||15-month Social Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723659|NCT00656513|3173071|Superiority|||||||0.48||||||15-month Personal/Psychological Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723660|NCT00656513|3173071|Superiority|||||||0.3||||||15-month Pain/Discomfort; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723661|NCT00656513|3173071|Superiority|||||||0.45||||||15-month Physical Functioning; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723662|NCT00656513|3173071|Superiority|||||||0.45||||||9-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723663|NCT00656513|3173071|Superiority|||||||0.49||||||9-month Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723664|NCT00656513|3173071|Superiority|||||||0.09||||||9-month Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723665|NCT00656513|3173071|Superiority|||||||0.88||||||9-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723666|NCT00656513|3173071|Superiority|||||||0.58||||||6-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723667|NCT00656513|3173071|Superiority|||||||0.13||||||6-month Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723668|NCT00656513|3173071|Superiority|||||||0.28||||||6-month Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723669|NCT00656513|3173071|Superiority|||||||0.98||||||6-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723670|NCT00656513|3173071|Superiority|||||||0.28||||||4-month Social Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723671|NCT00656513|3173071|Superiority|||||||0.12||||||4 months Personal/Psychological Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723672|NCT00656513|3173071|Superiority|||||||0.78||||||4 months Pain/Discomfort score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723673|NCT00656513|3173071|Superiority|||||||0.35||||||4-month Physical Functioning score; two-sided test, significance level 0.05|Wilcoxon (Mann-Whitney)||||
1723674|NCT00656513|3173072|Superiority|||||||0.21||||||Two-sided test of values at 15 months.|Wilcoxon (Mann-Whitney)||||
1723675|NCT00656513|3173072|Superiority|||||||0.31||||||Two-sided test of values at 6 months.|Wilcoxon (Mann-Whitney)||||
1723676|NCT00656513|3173072|Superiority|||||||0.11||||||Two-sided test of values at 4 months.|Wilcoxon (Mann-Whitney)||||
1723677|NCT00656513|3173074|Superiority|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||An effect size of 0.50 was chosen for sample size calculation. On the basis of a 2-sided t test with alpha= 0.05 and 1 interim analysis, 130 patients were required for 80% statistical power. Adjustment by 10% for loss to follow-up and retrospective ineligibility of recruited study participants yielded a sample size of 144 patients. Actual power given only 96 patients was 68.6%|
1723678|NCT00656370|3173088|Superiority|||||||0.67|||||||Wilcoxon signed rank test||||
1723679|NCT00656370|3173089|Superiority|||||||0.93|||||||Wilcoxon signed rank test||||
1723680|NCT00656201|3173101|Non-Inferiority or Equivalence|This was an equivalence comparison. The study was designed to detect a 14% pregnancy difference between the arms with 80% power and one interim analysis using O'Brien-Fleming parameters and an experiment-wise alpha level of 5%.|Odds Ratio (OR)|1.2|||<|0.05|2-Sided|95.0|0.8|1.8|||Wilcoxon (Mann-Whitney)||Crinone is the numerator and IM Progesterone is the denominator.||
1723681|NCT00656175|3173102|Superiority or Other|||||||0.52|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon sign-rank test used for statistical significance.|
1723682|NCT00656136|3173103|Superiority or Other||Odds Ratio (OR)|15.61||||0.0071|2-Sided|95.0|2.1|115.0||P-value is derived from logistic regression model adjusted for stratification factors, gender and baseline ECOG score (0, 1 vs 2)|Regression, Logistic|Model stratified by gender and baseline ECOG score (0,1 vs 2)|||
1723683|NCT00656136|3173104|Superiority or Other||Hazard Ratio (HR)|0.381|||<|0.0001|2-Sided|95.0|0.306|0.475||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)|||
1723684|NCT00656136|3173105|Superiority or Other||Hazard Ratio (HR)|0.976||||0.3955|2-Sided|95.0|0.814|1.17||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||Final analysis was performed after 526 deaths were observed among randomized patients. The data cut-off date for the final analysis was 04 October 2013.|
1723685|NCT00656136|3173105|Superiority or Other||Hazard Ratio (HR)|1.077||||0.7428|2-Sided|95.0|0.862|1.346||P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)|Regression, Cox|Model stratified by gender and baseline ECOG score (0,1 vs 2)||Primary analysis was performed after 358 deaths were observed among randomized patients. The data cut-off date for the primary analysis was 08 July 2010.|
1723686|NCT00655928|3173117|Superiority|||||||0.09|||||||t-test, 2 sided||||
1723687|NCT00655876|3173121|Superiority|||||||0.17|||||||Chi-squared|Two-sided significance level = 0.05||2 years|
1723688|NCT00655876|3173121|Superiority|||||||0.77|||||||Chi-squared|Two-sided significance level = 0.05||1 year|
1723689|NCT00655876|3173121|Superiority|||||||0.04|||||||Chi-squared|Two-sided significance level = 0.05||6-8 weeks post-treatment|
1723690|NCT00655876|3173122|Superiority|||||||0.66|||||||Fisher Exact|One-sided significance level = 0.025|||
1723691|NCT00655876|3173124|Superiority||Hazard Ratio (HR)|0.92||||0.65|2-Sided|95.0|0.66|1.28|||Log Rank|One-sided significance level = 0.025|||
1723692|NCT00655876|3173125|Superiority||Hazard Ratio (HR)|0.9||||0.47|2-Sided|95.0|0.7|1.16|||Log Rank|||The sample size was based on the primary hypothesis of a 29% reduction in the hazard rate of death with cetuximab, corresponding to an increase in 2-year overall survival (OS) from 41% to 53% and a hazard ratio (λ[exp]/λ[cont]) of 0.71 in favor of the cetuximab arm. Assuming an exponential distribution and constant hazards, 400 patients were required to reach 281 OS events, with 80% statistical power, a 1-sided α of 0.025, 4.5 years of accrual, 2 years of follow-up, and 4 interim analyses.|
1723693|NCT00655863|3173143|Superiority or Other||Mean Difference (Final Values)|-253.711|||<|0.001||95.0|-394.161|-113.262||p-value and confidence interval presented without multiplicity adjustment.|ANCOVA|||The null hypothesis that there was no difference between Alogliptin 25 mg QD + Pioglitazone 30 mg QD and placebo QD groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curve for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.|
1723694|NCT00655863|3173143|Superiority or Other||Mean Difference (Final Values)|-307.229|||<|0.001|2-Sided|95.0|-443.168|-171.29||p-value and confidence interval presented without multiplicity adjustment.|ANCOVA|||The null hypothesis that there was no difference between Alogliptin 25 mg QD and placebo groups was tested at a 2-sided 0.05 significance level. The ANCOVA model used for the change in postprandial incremental area the curver for total triglycerides includes treatment and statin use as fixed effects and baseline AUC(0-8h) for total triglycerides as a covariate.|
1723695|NCT00655811|3173179|Superiority|||||||0.06|||||||t-test, 2 sided||||
1723696|NCT00655811|3173180|Superiority|||||||0.002|||||||t-test, 2 sided||||
1723697|NCT00655811|3173180|Superiority|||||||0.06|||||||t-test, 2 sided||||
1723698|NCT00655811|3173180|Superiority|||||||0.012|||||||t-test, 2 sided||||
1723699|NCT00655811|3173181|Superiority|||||||0.027|||||||t-test, 2 sided||||
1723700|NCT00655811|3173181|Superiority|||||||0.005|||||||t-test, 2 sided||||
1723701|NCT00655811|3173181|Superiority|||||||0.55|||||||t-test, 2 sided||||
1723702|NCT00655811|3173181|Superiority||||||<|0.05|||||||ANOVA|||One-way anova was used to compare the mean COVAS values between groups.|
1723703|NCT00655642|3173207|Non-Inferiority or Equivalence|Based on the aforementioned values, we calculated a sample size for each treatment arm of 131 patients. We increased this sample estimate to 150 per treatment arm (total of 600 patients) to account for anticipated study attrition. Based on an unplanned interim conditional power futility analysis done at 30% information fraction, the decision was made to end the trial early.The futility analysis found the observed differences were far less than what was deemed clinically important.|Median Difference (Final Values)|12.0|Standard Deviation|25.0||0.16||||||Being aware of the multiple comparison issues, we deliberately chose the 0.01 alpha level following a Bonferroni type of correction so that the overall type I error rate is about 0.05.|Kruskal-Wallis|We computed the effect of the 3 treatments relative to ondansetron.|Change in VAS score was calculated as (VAS 30 min - VAS baseline). We calculated the differences in median VAS reductions for each arm relative to ondansetron.|The null hypothesis is that ondanestron is not more effective in reducing nausea than metoclopramide, promethazine or isotonic normal saline. The sample size was chosen to detect a 12-mm difference in VAS improvement between ondanestron and any other treatment arm (assuming a SD of 25mm) at 90% power and 0.01 alpha significance level. We chose the 0.01 alpha level following a Bonferroni type of correction so that the overall type I error rate is about 0.05.|
1723704|NCT00655629|3173208|Superiority or Other||Cochran-Mantel-Haenszel|60.2391|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|CMH adjusted for age group and center||Statistical analysis applies to the total population.|
1723705|NCT00655629|3173209|Superiority or Other||Mean Difference (Final Values)|-30.758|||<|0.0001||95.0|-36.736|-24.779|||ANOVA|||Statistical analysis applies to the total population.|
1723706|NCT00655629|3173210|Superiority or Other||Mean Difference (Final Values)|-22.379|||<|0.0001||95.0|-28.006|-16.753|||ANCOVA|||Statistical analysis applies to the total population.|
1723707|NCT00655629|3173211|Superiority or Other||Mean Difference (Final Values)|-18.418|||<|0.0001||95.0|-24.439|-12.396|||ANCOVA|||Statistical analysis applies to the total population.|
1723708|NCT00655629|3173212|Superiority or Other||Mean Difference (Final Values)|-19.496|||<|0.0001||95.0|-24.676|-14.315|||ANCOVA|||Statistical analysis applies to the total population.|
1723709|NCT00655629|3173213|Superiority or Other||Mean Difference (Final Values)|-26.04|||<|0.0001||95.0|-31.547|-20.533|||ANCOVA|||Statistical analysis applies to the total population.|
1723710|NCT00655629|3173214|Superiority or Other||Mean Difference (Final Values)|-16.866|||<|0.0001||95.0|-22.599|-11.133|||ANCOVA|||Statistical analysis applies to the total population.|
1723711|NCT00655629|3173216|Superiority or Other||Mean Difference (Final Values)|-20.902|||<|0.0001||95.0|-27.724|-14.081|||ANCOVA|||Statistical analysis applies to the total population.|
1723712|NCT00655629|3173217|Superiority or Other||Mean Difference (Final Values)|-33.934|||<|0.0001||95.0|-41.119|-26.749|||ANCOVA|||Statistical analysis applies to the total population.|
1723713|NCT00655629|3173218|Superiority or Other||Mean Difference (Final Values)|-33.134|||<|0.0001||95.0|-40.281|-25.987|||ANCOVA|||Statistical analysis applies to the total population.|
1723714|NCT00655629|3173219|Superiority or Other||Mean Difference (Final Values)|-16.078|||<|0.0001||95.0|-22.41|-9.746|||ANCOVA|||Statistical analysis applies to the total population.|
1723715|NCT00655629|3173220|Superiority or Other||Cochran-Mantel-Haenszel|53.8693|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|CMH adjusted for age group and center||Statistical analysis applies to the total population.|
1723716|NCT00655629|3173221|Superiority or Other||Mean Difference (Final Values)|-33.432|||<|0.0001||95.0|-40.439|-26.425|||ANCOVA|||Statistical analysis applies to the total population.|
1723717|NCT00655629|3173222|Superiority or Other||Mean Difference (Final Values)|-25.972|||<|0.0001||95.0|-32.688|-19.256|||ANCOVA|||Statistical analysis applies to the total population.|
1723718|NCT00655629|3173223|Superiority or Other||Mean Difference (Final Values)|-6.92|||<|0.0001||95.0|-8.45|-5.38|||ANCOVA|||Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.|
1723927|NCT00651261|3173751|Superiority or Other||Hazard Ratio (HR)|0.78||||0.0024|2-Sided|95.0|0.66|0.93|||1-sided stratified log rank||||
1723719|NCT00655356|3173248|Superiority or Other|||||||0.0075|||||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.|
1723720|NCT00655356|3173249|Superiority or Other||||||<|1e-05|||||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.|
1723721|NCT00654953|3173257|Superiority or Other|||||||0.05|||||||ANOVA|degrees of freedom for medication group = 2 (group)||The analysis tested the null hypothesis of no difference among groups in terms of the # of days to relapse (first two conseqcutively positive urines) using ANOVA.|
1723722|NCT00654940|3173258|Superiority or Other||Mean Difference (Final Values)|29000.0|Standard Error of the Mean|17000.0||||80.0|6100.0|51000.0||||||Difference in least squares means Pregabalin-Placebo. Model of day (8 am to 8 pm) total activity score at end of treatment. Mixed effects analysis of covariance model was fitted on the full analysis set population, accounting for period and treatment effects. Subject was fitted as a random effect and baseline was fitted as two covariates.|
1723723|NCT00654940|3173259|Superiority or Other||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|2.493||||80.0|-3.82|2.78||||||Neuropathic Pain Symptom Inventory treatment comparison: Pregabalin - Placebo. Total score was analyzed using a mixed effect analysis of covariance model based on the full analysis set (FAS), accounting for period and treatment effects. Subject was fitted as a random effect and baseline was fitted as two covariates.|
1723724|NCT00654940|3173260|Superiority or Other||Mean Difference (Final Values)|-0.81|Standard Error of the Mean|0.305||||80.0|-1.21|-0.41||||||Treatment comparison of pregabalin - placebo: mixed effects analysis of covariance model fitted on the full analysis set population, accounting for period and treatment effects. Subject was fitted as a random effect, and baseline was fitted as two covariates.|
1723725|NCT00654745|3173307|Superiority or Other||Mean Difference (Net)|-15.1|||<|0.0001|2-Sided|95.0|-16.5|-13.6||Change in mean seated diastolic blood pressure from baseline to week 18|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723726|NCT00654745|3173307|Superiority or Other||Mean Difference (Net)|-14.4|||<|0.0001|2-Sided|95.0|-15.7|-13.1||Change in mean seated diastolic blood pressure from baseline to week 15|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723727|NCT00654745|3173307|Superiority or Other||Mean Difference (Net)|-11.2|||<|0.0001|2-Sided|95.0|-12.5|-9.9||Change in mean seated diastolic blood pressure from baseline to week 12|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723728|NCT00654745|3173307|Superiority or Other||Mean Difference (Net)|-9.7|||<|0.0001|2-Sided|95.0|-10.9|-8.4||Change in mean seated diastolic blood pressure from baseline to week 9|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723729|NCT00654745|3173307|Superiority or Other||Mean Difference (Net)|-8.2|||<|0.0001|2-Sided|95.0|-9.4|-7.1||Change in mean seated diastolic blood pressure from baseline to week 6|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723730|NCT00654745|3173307|Superiority or Other||Mean Difference (Net)|-4.1|||<|0.0001|2-Sided|95.0|-5.1|-3.1||Change in mean seated diastolic blood pressure from baseline to week 3.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723731|NCT00654745|3173308|Superiority or Other||Mean Difference (Net)|-31.1|||<|0.0001|2-Sided|95.0|-33.3|-28.8||Change in mean seated systolic blood pressure from baseline to week 18|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723732|NCT00654745|3173308|Superiority or Other||Mean Difference (Net)|-28.5|||<|0.0001|2-Sided|95.0|-30.8|-26.2||Change in mean seated systolic blood pressure from baseline to week 15|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723733|NCT00654745|3173308|Superiority or Other||Mean Difference (Net)|-23.7|||<|0.0001|2-Sided|95.0|-25.7|-21.7||Change in mean seated systolic blood pressure from baseline to week 12|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723895|NCT00652626|3173624|Superiority or Other (legacy)||Ratio (%) of Geometric Means|101.1|||||2-Sided|90.0|71.2|143.6|||||Ratio of geometric mean is calculated as Azacitidine 50 mg/m^2 / Azacitidine 25 mg/m^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m^2 is the reference group for comparisons.|
1723734|NCT00654745|3173308|Superiority or Other||Mean Difference (Net)|-20.0|||<|0.0001|2-Sided|95.0|-22.2|-17.8||Change in mean seated systolic blood pressure from baseline to week 9|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723735|NCT00654745|3173308|Superiority or Other||Mean Difference (Net)|-17.9|||<|0.0001|2-Sided|95.0|-19.8|-16.1||Change in mean seated systolic blood pressure from baseline to week 6.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723736|NCT00654745|3173308|Superiority or Other||Mean Difference (Net)|-10.3|||<|0.0001|2-Sided|95.0|-12.0|-8.6||Change in mean seated systolic blood pressure from baseline to week 3.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with n-1 degrees of freedom||Primary null hypothesis is change from baseline is 0. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723737|NCT00654745|3173309|Superiority or Other||Mean Difference (Net)|-19.5|||<|0.0001|2-Sided|95.0|-21.7|-17.4||last 2 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723738|NCT00654745|3173309|Superiority or Other||Mean Difference (Net)|-19.1|||<|0.0001|2-Sided|95.0|-21.1|-17.1||last 4 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723739|NCT00654745|3173309|Superiority or Other||Mean Difference (Net)|-18.9|||<|0.0001|2-Sided|95.0|-20.7|-17.0||last 6 hours mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723740|NCT00654745|3173309|Superiority or Other||Mean Difference (Net)|-18.5|||<|0.0001|2-Sided|95.0|-20.4|-16.6||nighttime mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723741|NCT00654745|3173309|Superiority or Other||Mean Difference (Net)|-20.8|||<|0.0001|2-Sided|95.0|-22.6|-18.9||daytime mean SBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723742|NCT00654745|3173310|Superiority or Other||Mean Difference (Net)|-11.5|||<|0.0001|2-Sided|95.0|-13.1|-10.0||last 2 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723743|NCT00654745|3173310|Superiority or Other||Mean Difference (Net)|-11.1|||<|0.0001|2-Sided|95.0|-12.4|-9.8||last 4 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723744|NCT00654745|3173310|Superiority or Other||Mean Difference (Net)|-10.9|||<|0.0001|2-Sided|95.0|-12.2|-9.7||last 6 hours mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723745|NCT00654745|3173310|Superiority or Other||Mean Difference (Net)|-10.4|||<|0.0001|2-Sided|95.0|-11.7|-9.0||nighttime mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723746|NCT00654745|3173310|Superiority or Other||Mean Difference (Net)|-11.7|||<|0.0001|2-Sided|95.0|-12.9|-10.5||daytime mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723928|NCT00651261|3173752|Superiority or Other||Hazard Ratio (HR)|0.78||||0.009|2-Sided|95.0|0.63|0.96|||1-sided stratified log-rank||||
1724495|NCT00635349|3175424|Superiority or Other|||||||0.9834||||||Day 57; p-value was calculated by Chi-squared test|Chi-squared||||
1723747|NCT00654745|3173310|Superiority or Other||Mean Difference (Net)|-11.2|||<|0.0001|2-Sided|95.0|-12.2|-10.3||24-hour mean DBP change from baseline to week 12.|t-test, 2 sided|standard 1-sample confidence interval construction using t-distribution with 164 degrees of freedom||Primary null hypothesis is change from baseline to week12 in ABPM is 0. Change from baseline to week12 is primary efficacy variable and used all ABPM subjects. Null hypothesis used 1-sample t-test on change. Sample size of 200 expected to provide 99% power at significance level of 0.05%.|
1723748|NCT00654745|3173311|Superiority or Other||Mean Difference (Net)|-19.9|||<|0.0001|2-Sided|95.0|-21.5|-18.4|||t-test, 2 sided||||
1723749|NCT00654498|3173332|Superiority or Other||||||<|0.0001|||||||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate|||
1723750|NCT00654498|3173333|Superiority or Other||Mean Difference (Final Values)|-0.71|Standard Error of the Mean|0.25||0.0048|2-Sided|95.0|-1.2|-0.22|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate|||
1723751|NCT00654498|3173334|Superiority or Other||Mean Difference (Final Values)|-0.33|Standard Error of the Mean|0.18||0.0771|2-Sided|95.0|-0.69|0.04|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate|||
1723752|NCT00654498|3173335|Superiority or Other||Mean Difference (Final Values)|-0.54|Standard Error of the Mean|0.26||0.0402|2-Sided|95.0|-1.06|-0.02|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate|||
1723753|NCT00654498|3173336|Superiority or Other||Mean Difference (Final Values)|-1.36|Standard Error of the Mean|0.33|<|0.0001|2-Sided|95.0|-2.0|-0.72|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate|||
1723754|NCT00654498|3173337|Superiority or Other||Mean Difference (Final Values)|-1.36|Standard Error of the Mean|0.32|<|0.0001|2-Sided|95.0|-1.99|-0.73|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate|||
1723755|NCT00654498|3173338|Superiority or Other||Mean Difference (Final Values)|-1.48|Standard Error of the Mean|0.33|<|0.0001|2-Sided|95.0|-2.14|-0.83|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate|||
1723756|NCT00654498|3173339|Superiority or Other|||||||0.1386|||||||Chi-squared||||
1723757|NCT00654498|3173340|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|test stratified by centre|||
1723758|NCT00654498|3173341|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|test stratified by centre|||
1723759|NCT00654498|3173342|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|test stratified by centre|||
1723760|NCT00654498|3173343|Superiority or Other||Mean Difference (Final Values)|-4.52|Standard Error of the Mean|1.05|<|0.0001|2-Sided|95.0|-6.58|-2.46|||ANCOVA|ANCOVA with treatment and center as fixed factors and baseline as a covariate|||
1723761|NCT00654420|3173344|Superiority or Other||Difference in Percentage|-2.8||||0.721|2-Sided|95.0|-15.9|9.4|||Miettinen & Nurminen Method|||Miettinen and Nurminen’s method for stratified data was used for comparison of percentage of participants with objective response (ORR) between the two treatment groups. Response rate calculation was based on full follow-up.|
1723762|NCT00654420|3173345|Superiority or Other||Hazard Ratio (HR)|1.44||||0.879|2-Sided|95.0|0.78|2.64|||Regression, Cox|||The treatment difference in survival between treatment groups was assessed by Cox regression. The estimated hazard ratio for treatment of the Dalotuzumab (10 mg/kg) + Erlotinib treatment arm compared to the Erlotinib treatment arm was reported from the Cox model.|
1723763|NCT00654420|3173346|Superiority or Other||Hazard Ratio (HR)|0.86||||0.268|2-Sided|95.0|0.47|1.57|||Finkelstein Proportional Hazards Model|||Finkelstein proportional hazards model for interval-censored data was used to assess treatment effect on PFS in Phase II. The hazard ratio with 95% confidence interval for the Dalotuzumab (10 mg/kg) + Erlotinib treatment arm compared to the Erlotinib treatment arm was reported.|
1723764|NCT00654381|3173350|Superiority or Other||Least Squares Mean Difference|-9.8|Standard Error of the Mean|3.1||0.0015|2-Sided|95.0|-15.8|-3.8|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 10 mg vs voglibose at week 26|
1723765|NCT00654381|3173350|Superiority or Other||Least Squares Mean Difference|-6.9|Standard Error of the Mean|3.1||0.0239|2-Sided|95.0|-13.0|-0.9|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 5 mg vs Voglibose at week 26|
1723766|NCT00654381|3173351|Superiority or Other||Least Squares Mean Difference|-20.4|Standard Error of the Mean|2.9|<|0.0001|2-Sided|95.0|-26.2|-14.7|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 10 mg vs placebo at week 12|
1723767|NCT00654381|3173351|Superiority or Other||Least Squares Mean Difference|-19.7|Standard Error of the Mean|2.9|<|0.0001|2-Sided|95.0|-25.4|-14.0|||ANCOVA|Model includes treatment,baseline FPG, and number of previous antidiabetic medication||Linagliptin 5 mg vs placebo at week 12|
1723768|NCT00654381|3173355|Superiority or Other||Least Squares Mean Difference|-0.39|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-0.56|-0.21|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 10 mg vs voglibose at week 26|
1723769|NCT00654381|3173355|Superiority or Other||Least Squares Mean Difference|-0.32|Standard Error of the Mean|0.09|<|0.0003|2-Sided|95.0|-0.49|-0.15|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication|||
1723770|NCT00654381|3173356|Superiority or Other||Least Squares Mean Difference|-0.88|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-1.05|-0.71|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 10 mg vs placebo at week 12|
1723771|NCT00654381|3173356|Superiority or Other||Least Squares Mean Difference|-0.87|Standard Error of the Mean|0.09|<|0.0001|2-Sided|95.0|-1.04|-0.7|||ANCOVA|Model includes treatment,baseline HbA1c, and number of previous antidiabetic medication||Linagliptin 5 mg vs placebo at week 12|
1723772|NCT00654368|3173369|Non-Inferiority or Equivalence|If the lower bound of the one-sided 95% confidence interval (CI), defined below, exceeded the noninferiority margin of -0.6, then noninferiority was to be concluded.|Mean Difference|-0.41|||||2-Sided|95.0|-0.75|-0.06|||||The 95% CI was calculated using the mean square error from an analysis of variance (ANOVA) fitted with effects for treatment and covariates of duration of disease, type of reimbursement, and 6 month DAS28.||
1723773|NCT00653991|3173395|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1724496|NCT00635349|3175424|Superiority or Other|||||||0.0131||||||Day 29: p-value was calculated by fisher exact test|Fisher Exact||||
1723774|NCT00653263|3173411|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.|
1723775|NCT00653263|3173412|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||Means and ranges were computed for continuous baseline(BL)characteristics.For longitudinal data,Proc GLIMMIX in SAS was used to fit a Mixed Model with Random Intercept.For data with 5 time points, hypothesis tests were performed to test for a differences between BL and each subsequent time point as well as differences between each time point. For data with 3 time points, hypothesis tests were performed to test for a differences between BL and wk 2,wk 2and wk 4,as well as between BL and wk 4.|
1723776|NCT00653263|3173413|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||Means and ranges were computed for the continuous baseline characteristics.For data with 5 time points (baseline and weeks 1 through 4), hypothesis tests were performed to test for a differences between baseline and each subsequent time point as well as differences between each time point For data with 3 time points hypothesis tests were performed to test for a differences between baseline and wk 2, wk 2 and wk 4, as well as between baseline and wk 4.|
1723777|NCT00653224|3173414|Superiority or Other|||||||0.171||||||If the p-value of this estimated difference is lower than 5% the change from baseline is considered as different between the two treatment groups.|Repeated measure analysis (CATMOD)|||The Null Hypothesis is expressed as follows: ‘The change from baseline to endpoint visit in score category (ESS score < 8 or >= 8) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723778|NCT00653224|3173415|Superiority or Other||Mean Difference (Final Values)|-0.64||||0.042||95.0|-1.26|-0.02||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in ESS score at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723779|NCT00653224|3173416|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.535||95.0|-0.7|0.37||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in ESS score at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723780|NCT00653224|3173417|Superiority or Other||Mean Difference (Final Values)|-0.68||||0.027||95.0|-1.29|-0.08||If the p-value of this estimated difference is lower than 5% the mean change from baseline in ESS score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in ESS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in ESS score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723781|NCT00653224|3173418|Superiority or Other||Mean Difference (Final Values)|-5.69||||0.001||95.0|-9.16|-2.21||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 7) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723782|NCT00653224|3173419|Superiority or Other||Mean Difference (Final Values)|-6.62|||<|0.001||95.0|-9.88|-3.35||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 7) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723783|NCT00653224|3173420|Superiority or Other||Mean Difference (Final Values)|-5.91|||<|0.001||95.0|-9.34|-2.47||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 7) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 7) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723784|NCT00653224|3173421|Superiority or Other||Mean Difference (Final Values)|-5.96||||0.288||95.0|-17.13|5.22||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 6) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723921|NCT00651755|3173689|Non-Inferiority or Equivalence|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|0.97|Standard Deviation|0.35|||2-Sided|90.0|0.83|1.13|||||Ratio Geometric Mean AUC of Analyte, 4-OHCP, between Aprepitant treatment to control Group||
1723785|NCT00653224|3173422|Superiority or Other||Mean Difference (Final Values)|-7.06||||0.258||95.0|-19.48|5.36||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 6) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723786|NCT00653224|3173423|Superiority or Other||Mean Difference (Final Values)|-6.37||||0.251||95.0|-17.4|4.67||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 6) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 6) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723787|NCT00653224|3173424|Superiority or Other||Median Difference (Final Values)|-4.24||||0.45||95.0|-15.46|6.99||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 5) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723788|NCT00653224|3173425|Superiority or Other||Mean Difference (Final Values)|-4.54||||0.432||95.0|-16.1|7.01||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 5) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723789|NCT00653224|3173426|Superiority or Other||Mean Difference (Final Values)|-4.58||||0.409||95.0|-15.65|6.49||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 5) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 5) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723790|NCT00653224|3173427|Superiority or Other||Mean Difference (Final Values)|-4.38||||0.117||95.0|-9.91|1.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 4) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723791|NCT00653224|3173428|Superiority or Other||Mean Difference (Final Values)|-1.44||||0.493||95.0|-5.66|2.78||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 4) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723792|NCT00653224|3173429|Superiority or Other||Mean Difference (Final Values)|-4.51||||0.102||95.0|-9.95|0.93||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 4) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 4) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723793|NCT00653224|3173430|Superiority or Other||Mean Difference (Final Values)|-4.11||||0.036||95.0|-7.95|-0.27||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 3) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723794|NCT00653224|3173431|Superiority or Other||Mean Difference (Final Values)|-4.56||||0.015||95.0|-8.23|-0.89||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 3) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1724043|NCT00645099|3174156|Superiority or Other|||||||0.0018|||||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.|
1723795|NCT00653224|3173432|Superiority or Other||Mean Difference (Final Values)|-4.44||||0.023||95.0|-8.25|-0.63||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 3) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 3) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723796|NCT00653224|3173433|Superiority or Other||Mean Difference (Final Values)|-4.25||||0.027||95.0|-8.02|-0.47||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 2) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723797|NCT00653224|3173434|Superiority or Other||Mean Difference (Final Values)|-4.33||||0.017||95.0|-7.88|-0.79||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 2) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723798|NCT00653224|3173435|Superiority or Other||Mean Difference (Final Values)|-4.6||||0.016||95.0|-8.34|-0.86||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 2) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 2) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723799|NCT00653224|3173436|Superiority or Other||Mean Difference (Final Values)|-1.5||||0.015||95.0|-2.72|-0.29||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 1) at week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723800|NCT00653224|3173437|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.554||95.0|-1.56|0.84||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 1) at week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723801|NCT00653224|3173438|Superiority or Other||Mean Difference (Final Values)|-1.36||||0.027||95.0|-2.56|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in WPAI-AS score (dimension 1) is considered as different between the two treatment groups.|ANCOVA|ANCOVA on change from baseline in the WPAI:AS score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in WPAI-AS score (dimension 1) at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723802|NCT00653224|3173439|Superiority or Other||||||<|0.001||||||If the p-value is lower than 5% the distribution is considered as different between the two treatment groups.|Wilcoxon (Mann-Whitney)|||The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test (Lehmann, 1975 page 23) is generally used to detect ‘shift alternatives’. That is, the two distributions have the same general shape, but one of them is shifted relative to the other by a constant amount under the alternative hypothesis.|
1723803|NCT00653224|3173440|Superiority or Other||||||<|0.001||||||If the p-value is lower than 5% the distribution is considered as different between the two treatment groups.|Wilcoxon (Mann-Whitney)|||The Wilcoxon-Mann-Whitney, or Wilcoxon rank-sum test is generally used to detect ‘shift alternatives’. That is, the two distributions have the same general shape, but one of them is shifted relative to the other by a constant amount under the alternative hypothesis.|
1723804|NCT00653224|3173441|Superiority or Other||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The ocular redness mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723805|NCT00653224|3173442|Superiority or Other||Mean Difference (Final Values)|-0.22|||<|0.001||95.0|-0.34|-0.1||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The ocular redness mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1724487|NCT00635492|3175401|Superiority or Other||Odds Ratio (OR)|0.77|||<|0.0001|2-Sided|95.0|0.69|0.86|||Regression, Logistic|||Most recent HbA1c at baseline - 1% higher.|
1723806|NCT00653224|3173443|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.004||95.0|-0.27|-0.05||If the p-value of this estimated difference is lower than 5% the ocular redness mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Redness Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The ocular redness mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723807|NCT00653224|3173444|Superiority or Other||Mean Difference (Final Values)|-0.18|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The ocular tearing/watering mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723808|NCT00653224|3173445|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.011||95.0|-0.29|-0.04||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The ocular tearing/watering mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723809|NCT00653224|3173446|Superiority or Other||Mean Difference (Final Values)|-0.2|||<|0.001||95.0|-0.31|-0.1||If the p-value of this estimated difference is lower than 5% the ocular tearing/watering mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Tearing/Watering Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The ocular tearing/watering mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723810|NCT00653224|3173447|Superiority or Other||Mean Difference (Final Values)|-0.18|||<|0.001||95.0|-0.29|-0.08||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The ocular itching/burning mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723811|NCT00653224|3173448|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.006||95.0|-0.29|-0.05||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The ocular itching/burning mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723812|NCT00653224|3173449|Superiority or Other||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.3|-0.08||If the p-value of this estimated difference is lower than 5% the ocular itching/burning mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Itching/Burning Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The ocular itching/burning mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723813|NCT00653224|3173450|Superiority or Other||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.1||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The ocular pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723814|NCT00653224|3173451|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.002||95.0|-0.33|-0.08||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The ocular pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723815|NCT00653224|3173452|Superiority or Other||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.1||If the p-value of this estimated difference is lower than 5% the ocular pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Ocular Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The ocular pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723816|NCT00653224|3173453|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.065||95.0|-0.21|0.01||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The post-nasal drip mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1724488|NCT00635492|3175402|Superiority or Other||Odds Ratio (OR)|1.16|||<|0.0001|2-Sided|95.0|1.13|1.19|||Regression, Logistic|||Body Mass Index (BMI) – 1kg/m² higher|
1723817|NCT00653224|3173454|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.117||95.0|-0.23|0.03||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The post-nasal drip mean score over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723818|NCT00653224|3173455|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.088||95.0|-0.2|0.01||If the p-value of this estimated difference is lower than 5% the post-nasal drip mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Post-Nasal Drip Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The post-nasal drip mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723819|NCT00653224|3173456|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.003||95.0|-0.27|-0.06||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The nasal pruritus mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723820|NCT00653224|3173457|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.016||95.0|-0.28|-0.03||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The nasal pruritus mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723821|NCT00653224|3173458|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.002||95.0|-0.28|-0.06||If the p-value of this estimated difference is lower than 5% the nasal pruritus mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Pruritus Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The nasal pruritus mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723822|NCT00653224|3173459|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.124||95.0|-0.19|0.02||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The nasal congestion mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723823|NCT00653224|3173460|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.063||95.0|-0.24|0.01||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The nasal congestion mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723824|NCT00653224|3173461|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.384||95.0|-0.15|0.06||If the p-value of this estimated difference is lower than 5% the nasal congestion mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Nasal Congestion Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The nasal congestion mean score over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723825|NCT00653224|3173462|Superiority or Other||Mean Difference (Final Values)|-0.19|||<|0.001||95.0|-0.3|-0.09||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The rhinorrhea mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723826|NCT00653224|3173463|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.008||95.0|-0.3|-0.05||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The rhinorrhea mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723827|NCT00653224|3173464|Superiority or Other||Mean Difference (Final Values)|-0.21|||<|0.001||95.0|-0.32|-0.11||If the p-value of this estimated difference is lower than 5% the rhinorrhea mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Rhinorrhea Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The rhinorrhea mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723922|NCT00651755|3173690|Non-Inferiority or Equivalence|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|ratio Geometric mean AUC|0.75|Standard Deviation|0.29|||2-Sided|95.0|0.65|0.86|||||The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment and the control group||
1723828|NCT00653224|3173465|Superiority or Other||Mean Difference (Final Values)|-0.23|||<|0.001||95.0|-0.33|-0.12||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The sneezing mean score over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723829|NCT00653224|3173466|Superiority or Other||Mean Difference (Final Values)|-0.22|||<|0.001||95.0|-0.34|-0.09||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The sneezing mean score over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723830|NCT00653224|3173467|Superiority or Other||Mean Difference (Final Values)|-0.23|||<|0.001||95.0|-0.34|-0.13||If the p-value of this estimated difference is lower than 5% the sneezing mean score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Sneezing Mean Score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The sneezing mean score over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723831|NCT00653224|3173468|Superiority or Other||Mean Difference (Final Values)|-0.57|||<|0.001||95.0|-0.86|-0.28||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean TOSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723832|NCT00653224|3173469|Superiority or Other||Mean Difference (Final Values)|-0.57|||<|0.001||95.0|-0.91|-0.24||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean TOSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723833|NCT00653224|3173470|Superiority or Other||Mean Difference (Final Values)|-0.59|||<|0.001||95.0|-0.87|-0.3||If the p-value of this estimated difference is lower than 5% the mean TOSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TOSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean TOSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723834|NCT00653224|3173471|Superiority or Other||Mean Difference (Final Values)|-0.74|||<|0.001||95.0|-1.18|-0.3||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean TNSS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723835|NCT00653224|3173472|Superiority or Other||Mean Difference (Final Values)|-0.74||||0.005||95.0|-1.26|-0.22||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean TNSS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723836|NCT00653224|3173473|Superiority or Other||Mean Difference (Final Values)|-0.74|||<|0.001||95.0|-1.17|-0.31||If the p-value of this estimated difference is lower than 5% the mean TNSS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean TNSS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean TNSS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723837|NCT00653224|3173474|Superiority or Other||Mean Difference (Final Values)|-0.81|||<|0.001||95.0|-1.17|-0.45||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean T4SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723838|NCT00653224|3173475|Superiority or Other||Mean Difference (Final Values)|-0.76|||<|0.001||95.0|-1.18|-0.35||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean T4SS over Week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723839|NCT00653224|3173476|Superiority or Other||Mean Difference (Final Values)|-0.84|||<|0.001||95.0|-1.2|-0.49||If the p-value of this estimated difference is lower than 5% the mean T4SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the Mean T4SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean T4SS over Week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1724489|NCT00635362|3175415|Superiority or Other|||||||1|||||||Fisher Exact||||
1723840|NCT00653224|3173477|Superiority or Other||Mean Difference (Final Values)|-0.88|||<|0.001||95.0|-1.39|-0.36||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean T5SS over week 2 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723841|NCT00653224|3173478|Superiority or Other||Mean Difference (Final Values)|-0.89|||<|0.001||95.0|-1.32|-0.45||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean T5SS over week 1 is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723842|NCT00653224|3173479|Superiority or Other||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.53|-0.14||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ emotional score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723843|NCT00653224|3173480|Superiority or Other||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ emotional score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723844|NCT00653224|3173481|Superiority or Other||Mean Difference (Final Values)|-0.33|||<|0.001||95.0|-0.53|-0.13||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ emotional score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ emotional score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ emotional score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723845|NCT00653224|3173482|Superiority or Other||Mean Difference (Final Values)|-0.42|||<|0.001||95.0|-0.63|-0.22||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723846|NCT00653224|3173483|Superiority or Other||Mean Difference (Final Values)|-0.37|||<|0.001||95.0|-0.56|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723847|NCT00653224|3173484|Superiority or Other||Mean Difference (Final Values)|-0.42|||<|0.001||95.0|-0.63|-0.21||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ eye symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723848|NCT00653224|3173485|Superiority or Other||Mean Difference (Final Values)|-0.38|||<|0.001||95.0|-0.59|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ nasal symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723849|NCT00653224|3173486|Superiority or Other||Mean Difference (Final Values)|-0.35|||<|0.001||95.0|-0.55|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ nasal symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723896|NCT00652626|3173627|Superiority or Other (legacy)||Ratio (%) of Geometric Means|107.5|||||2-Sided|90.0|55.9|207.0|||||Ratio of geometric means is calculated as Azacitidine 100 mg/m^2 / Azacitidine 25 mg/m^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m^2 is the reference group for comparisons|
1723850|NCT00653224|3173487|Superiority or Other||Mean Difference (Final Values)|-0.38|||<|0.001||95.0|-0.59|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ nasal symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ nasal symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ nasal symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723851|NCT00653224|3173488|Superiority or Other||Mean Difference (Final Values)|-0.4|||<|0.001||95.0|-0.61|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ practical problems score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723852|NCT00653224|3173489|Superiority or Other||Mean Difference (Final Values)|-0.36|||<|0.001||95.0|-0.57|-0.16||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ practical problems score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723853|NCT00653224|3173490|Superiority or Other||Mean Difference (Final Values)|-0.39|||<|0.001||95.0|-0.61|-0.18||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ practical problems score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ practical pbs. score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ practical problems score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723854|NCT00653224|3173491|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.003||95.0|-0.47|-0.1||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723855|NCT00653224|3173492|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.006||95.0|-0.41|-0.07||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ non-nose/eye symptoms score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723856|NCT00653224|3173493|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.002||95.0|-0.47|-0.1||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ non-nose/eye symptoms score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ N-N/E symptoms score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as: ‘The mean change from baseline in RQLQ non-nose/eye symptoms score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723857|NCT00653224|3173494|Superiority or Other||Median Difference (Final Values)|-0.25||||0.018||95.0|-0.45|-0.04||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ sleep score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723858|NCT00653224|3173495|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.026||95.0|-0.43|-0.03||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ sleep score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723859|NCT00653224|3173496|Superiority or Other||Mean Difference (Final Values)|-0.27||||0.01||95.0|-0.48|-0.07||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ sleep score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ sleep score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ sleep score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1724044|NCT00645099|3174156|Superiority or Other|||||||0.4454|||||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.|
1723860|NCT00653224|3173497|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.036||95.0|-0.51|-0.02||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ activities score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723861|NCT00653224|3173498|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.014||95.0|-0.52|-0.06||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ activities score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723862|NCT00653224|3173499|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.042||95.0|-0.49|-0.01||If the p-value of this estimated difference is lower than 5% the mean change from baseline in RQLQ activities score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in RQLQ activities score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in RQLQ activities score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723863|NCT00653224|3173500|Superiority or Other||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in overall RQLQ score at visit 4 (week 2) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723864|NCT00653224|3173501|Superiority or Other||Mean Difference (Final Values)|-0.31|||<|0.001||95.0|-0.47|-0.15||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in overall RQLQ score at visit 3 (week 1) is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723865|NCT00653224|3173502|Superiority or Other||Mean Difference (Final Values)|-0.34|||<|0.001||95.0|-0.52|-0.17||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723866|NCT00653224|3173503|Superiority or Other||Mean Difference (Final Values)|-0.89|||<|0.001||95.0|-1.33|-0.45||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the mean of T5SS including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis for the primary endpoint is expressed as follows: ‘The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1723867|NCT00653159|3173504|Superiority or Other|||||||1|||||||Fisher Exact|Two-sided test||"Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject reported being satisfied (happy or very happy) at the 6 month study visit. Under the null hypothesis, satisfaction rates are similar for both IUD types."|
1723868|NCT00653159|3173505|Superiority or Other|||||||0.2174|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced expulsion of the IUD. Under the null hypothesis, expulsion rates are similar for both IUD types.|
1723869|NCT00653159|3173506|Superiority or Other|||||||0.4783|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject became pregnant within 6 months of IUD insertion. Under the null hypothesis, pregnancy rates are similar for both IUD types.|
1723870|NCT00653159|3173507|Superiority or Other|||||||0.4136|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced heavy bleeding. Under the null hypothesis, heavy bleeding rates are similar for both IUD types.|
1723871|NCT00653159|3173508|Superiority or Other|||||||0.4003|||||||Fisher Exact|Two-sided test||Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject completed the final study visit at 6 months. Under the null hypothesis, study completion rates are similar for both IUD types.|
1723872|NCT00653133|3173509|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Null hypothesis: There is no difference in reported complications associated with the placement of continuous peripheral nerve block catheters between ultrasound imaging guided placement and nerve stimulator guided placement.|
1723923|NCT00651755|3173691|Non-Inferiority or Equivalence|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.2|||||2-Sided|90.0|1.08|1.33|||||Ratio Geometric Mean AUC (Area Under Curve) of Analyte,CP, between Aprepitant treatment to control Group.||
1723873|NCT00652951|3173555|Non-Inferiority|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for protein D.|GMC ratio|0.91|||||2-Sided|95.0|0.77|1.06||||||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns protein D.|
1723874|NCT00652951|3173556|Non-Inferiority|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 23F.|GMC ratio|0.92|||||2-Sided|95.0|0.7|1.23||||||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa Group and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 23F.|
1723875|NCT00652951|3173556|Non-Inferiority|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 19F.|GMC ratio|1.06|||||2-Sided|95.0|0.82|1.36||||||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 19F.|
1723876|NCT00652951|3173556|Non-Inferiority|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 18C.|GMC ratio|1.61|||||2-Sided|95.0|1.28|2.03||||||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over ), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 18C.|
1723877|NCT00652951|3173556|Non-Inferiority|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 14.|GMC ratio|1.01|||||2-Sided|95.0|0.85|1.21||||||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 14.|
1723878|NCT00652951|3173556|Non-Inferiority|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 9V.|GMC ratio|0.95|||||2-Sided|95.0|0.78|1.16||||||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 9V.|
1723879|NCT00652951|3173556|Non-Inferiority|Non-inferiority criteria: The upper limit of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group Group), was lower than 2 for the pneumococcal vaccine serotype 7F.|GMC ratio|0.96|||||2-Sided|95.0|0.82|1.13||||||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel Group groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 7F.|
1723880|NCT00652951|3173556|Non-Inferiority|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 6B.|GMC ratio|0.93|||||2-Sided|95.0|0.69|1.26||||||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 6B.|
1723881|NCT00652951|3173556|Non-Inferiority|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 5.|GMC ratio|0.98|||||2-Sided|95.0|0.83|1.15||||||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 5.|
1723882|NCT00652951|3173556|Non-Inferiority|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% CI of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 4.|GMC ratio|1.01|||||2-Sided|95.0|0.84|1.23||||||The 2-sided 95% CI of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 4.|
1723897|NCT00652626|3173627|Superiority or Other (legacy)||Ratio (%) of Geometric Means|84.7|||||2-Sided|90.0|45.3|158.5|||||Ratio of geometric means is calculated as Azacitidine 75 mg/m^2 / Azacitidine 25 mg/m^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m^2 is the reference group for comparisons|
1723883|NCT00652951|3173556|Non-Inferiority|Non-inferiority criteria: The upper limit (UL) of the 2-sided 95% confidence interval (CI) of the GMC ratio for between groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), was lower than 2 for the pneumococcal vaccine serotype 1.|GMC ratio|0.89|||||2-Sided|95.0|0.74|1.07||||||The 2-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between the Synflorix + Infanrix hexa and Synflorix + Pediacel groups (Synflorix + Infanrix hexa Group over Synflorix + Pediacel Group), at one month after Dose 3 of pneumococcal vaccine, was computed for each of the 10 pneumococcal vaccine serotypes and protein D. This statistical method concerns pneumococcal vaccine serotype 1.|
1723884|NCT00652834|3173581|Superiority or Other||Mean Difference (Net)|0.0||||0.05|2-Sided|95.0||||The p value is only for GSRS score comparison only.|t-test, 2 sided||The GSRS range is 1-7|"The results of the initial SBCE exams were evaluated by a visually challenged GI specialist who gave us a descriptive report. By the end of the study, we submitted the final reports to the same specialist and asked his impression on the significant changes observed in patients' exams for each GI segment (stomach and small bowel).~There were no comparison groups. Each patient is their own control. Given that this is a pilot study there is no power calculation."|
1723885|NCT00652626|3173618|Superiority or Other (legacy)||Median Difference (Final Values)|0.25||||0.1017|2-Sided|90.0|0.0|0.5|||Wilcoxon (Mann-Whitney)||Median difference is Severe RI - Normal RF.|Comparison of Tmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.|
1723886|NCT00652626|3173618|Superiority or Other (legacy)||Median Difference (Final Values)|0.25||||0.1342|2-Sided|90.0|0.0|0.52|||Wilcoxon (Mann-Whitney)||Median difference is Severe RI - Normal RF.|Comparison of Tmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.|
1723887|NCT00652626|3173619|Superiority or Other (legacy)||Ratio (%) of Geometric Means|105.6|||||2-Sided|90.0|54.5|204.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of Cmax after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."|
1723888|NCT00652626|3173619|Superiority or Other (legacy)||Ratio (%) of Geometric Means|141.7|||||2-Sided|90.0|73.2|274.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of Cmax after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."|
1723889|NCT00652626|3173620|Superiority or Other (legacy)||Ratio (%) of Geometric Means|141.2|||||2-Sided|90.0|92.2|216.2|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-inf after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."|
1723890|NCT00652626|3173620|Superiority or Other (legacy)||Ratio (%) of Geometric Means|166.3|||||2-Sided|90.0|108.6|254.6|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-inf after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."|
1723891|NCT00652626|3173621|Superiority or Other (legacy)||Ratio (%) of Geometric Means|140.4|||||2-Sided|90.0|90.6|217.7|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-t after multiple doses (Day 5) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters."|
1723892|NCT00652626|3173621|Superiority or Other (legacy)||Ratio (%) of Geometric Means|169.3|||||2-Sided|90.0|109.2|262.5|||||Ratio of geometric mean is calculated as Severe RI/Normal RF and expressed as a percentage.|"Comparison of AUC0-t after a single dose (Day 1) in participants with normal renal function and participants with severe renal impairment.~Geometric means, ratio and 90% CI of ratio of geometric means are from an analysis of variance model with renal function group (normal and severe), visit (Day 1 and Day 5), renal function group by visit interaction as fixed effect, and patient nested within renal function group as a random effect on the nature log-transformed pharmacokinetic parameters"|
1723893|NCT00652626|3173624|Superiority or Other (legacy)||Ratio (%) of Geometric Means|101.4|||||2-Sided|90.0|71.4|143.9|||||Ratio of geometric mean is calculated as Azacitidine 100 mg/m^2 / Azacitidine 25 mg/m^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m^2 is the reference group for comparisons.|
1723894|NCT00652626|3173624|Superiority or Other (legacy)||Ratio (%) of Geometric Means|144.9|||||2-Sided|90.0|103.6|202.7|||||Ratio of geometric mean is calculated as Azacitidine 75 mg/m^2 / Azacitidine 25 mg/m^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance model on the nature log-transformed CL/F obtained on Day 1. Azacitidine 25 mg/m^2 is the reference group for comparisons.|
1723924|NCT00651625|3173725|Superiority or Other|||||||0.05|||||||t-test, 2 sided|||group comparisons using t-test and confidence intervals.|
1723925|NCT00651261|3173748|Superiority or Other|||||||0.0049|||||||1-sided stratified log rank||||
1723898|NCT00652626|3173627|Superiority or Other (legacy)||Ratio (%) of Geometric Means|127.7|||||2-Sided|90.0|66.3|245.7|||||Ratio of geometric means is calculated as Azacitidine 50 mg/m^2 / Azacitidine 25 mg/m^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized Cmax, obtained on Day 1. Azacitidine 25 mg/m^2 is the reference group for comparisons|
1723899|NCT00652626|3173628|Superiority or Other (legacy)||Ratio (%) of Geometric Means|83.2|||||2-Sided|90.0|54.5|127.1|||||Ratio of geometric mean is calculated as Azacitidine 100 mg/m^2 / Azacitidine 25 mg/m^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m^2 is the reference group for comparisons.|
1723900|NCT00652626|3173628|Superiority or Other (legacy)||Ratio (%) of Geometric Means|68.5|||||2-Sided|90.0|45.7|102.7|||||Ratio of geometric mean is calculated as Azacitidine 75 mg/m^2 / Azacitidine 25 mg/m^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-inf, obtained on Day 1. Azacitidine 25 mg/m^2 is the reference group for comparisons.|
1723901|NCT00652626|3173628|Superiority or Other (legacy)||Ratio (%) of Geometric Means|97.4|||||2-Sided|90.0|63.8|148.8|||||Ratio of geometric mean is calculated as Azacitidine 50 mg/m^2 / Azacitidine 25 mg/m^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0–inf, obtained on Day 1. Azacitidine 25 mg/m^2 is the reference group for comparisons.|
1723902|NCT00652626|3173629|Superiority or Other (legacy)||Ratio (%) of Geometric Means|82.7|||||2-Sided|90.0|53.8|127.2|||||Ratio of geometric means is calculated as Azacitidine 100 mg/m^2 / Azacitidine 25 mg/m^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m^2 is the reference group for comparisons|
1723903|NCT00652626|3173629|Superiority or Other (legacy)||Ratio (%) of Geometric Means|67.5|||||2-Sided|90.0|44.7|101.8|||||Ratio of geometric means is calculated as Azacitidine 75 mg/m^2 / Azacitidine 25 mg/m^2 and expressed as a percentage.|Geometric means, ratio and 90% CI of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m^2 is the reference group for comparisons|
1723904|NCT00652626|3173629|Superiority or Other (legacy)||Ratio (%) of Geometric Means|98.4|||||2-Sided|90.0|64.0|151.3|||||Ratio of geometric means is calculated as Azacitidine 50 mg/m^2 / Azacitidine 25 mg/m^2 and expressed as a percentage.|Geometric means, ratio and 90% confidence interval (CI) of ratio of geometric means are from one way analysis of variance models on the nature log-transformed dose-normalized AUC0-t, obtained on Day 1. Azacitidine 25 mg/m^2 is the reference group for comparisons|
1723905|NCT00652366|3173631|Superiority or Other||Hazard Ratio (HR)|0.79||||0.1596|2-Sided|95.0|0.57|1.1|||Log Rank||||
1723906|NCT00652366|3173631|Superiority or Other||Hazard Ratio (HR)|0.69||||0.0217|2-Sided|95.0|0.51|0.95|||Log Rank||||
1723907|NCT00652366|3173633|Superiority or Other||Hazard Ratio (HR)|1.03||||0.8449|2-Sided|95.0|0.74|1.43|||Log Rank||||
1723908|NCT00652366|3173633|Superiority or Other||Hazard Ratio (HR)|0.83||||0.2678|2-Sided|95.0|0.6|1.15|||Log Rank||||
1723909|NCT00652366|3173635|Superiority or Other||Difference in Disease Control Rates|-15.52||||0.0603|2-Sided|95.0|-32.4|1.3|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.||
1723910|NCT00652366|3173637|Superiority or Other||Odds Ratio (OR)|0.55|||||2-Sided|95.0|0.19|1.56|||||||
1723911|NCT00652366|3173637|Superiority or Other||Difference in Response Rates|-6.1||||0.2543|2-Sided|95.0|-17.2|5.0|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.||
1723912|NCT00652366|3173638|Superiority or Other||Hazard Ratio (HR)|1.09||||0.6298|2-Sided|95.0|0.77|1.54|||Log Rank||||
1723913|NCT00652366|3173640|Superiority or Other||Hazard Ratio (HR)|1.26||||0.2026|2-Sided|95.0|0.88|1.8|||Log Rank||||
1723914|NCT00652327|3173644|Superiority or Other|||||||0.0026|||||||Wilcoxon rank sum test||||
1723915|NCT00651820|3173679|Superiority or Other||Mean Difference (Final Values)|-5.88|||<|0.05|2-Sided|95.0|||||t-test, 2 sided|||Energy Absorption: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments|
1723916|NCT00651820|3173679|Superiority or Other||Mean Difference (Final Values)|10.2|||<|0.05|2-Sided|95.0|||||t-test, 2 sided|||Stiffness: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments|
1723917|NCT00651820|3173680|Superiority or Other||||||<|0.05|||||||Paired-Prentice Wilcoxon (PPW)|Time to complete wound closure Drug(T1)and Vehicle(T2)Hypothesis, Ho: T1=T2,using paired Prentice-Wilcoxon at significant level of 5%, 2-sided.||Each subject served as their own control, each receiving duplicate dermatome-induced wounds with 1 wound treated with active drug and the other treated with vehicle. Mean time to wound closure was calculated for the wounds treated with drug, the wounds treated with vehicle, and an over-all mean time to wound closure|
1723918|NCT00651755|3173686|Non-Inferiority or Equivalence|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.16|Standard Deviation|0.47|||2-Sided|90.0|1.01|1.32|||||Ratio Geometric Mean AUC (Area Under Curve) of Analyte,PL, Between Aprepitant treatment to control Group.||
1723919|NCT00651755|3173687|Non-Inferiority or Equivalence|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.08|Standard Deviation|0.17||||90.0|1.02|1.15|||||The geometric mean AUC ratio is the ratio of geometric mean AUC between aprepitant treatment and the control group.||
1723920|NCT00651755|3173688|Non-Inferiority or Equivalence|The absence of pharmacokinetic drug interactions can be determined if the 90% CI of the geometric mean AUC ratio between 2 groups is within 0.80 to 1.25.|Ratio Geometric Mean AUC|1.04|Standard Deviation|0.68|||2-Sided|90.0|0.82|1.33|||||Ratio Geometric Mean AUC (Area Under Curve) of Analyte, VC, Between Aprepitant treatment to control Group.||
1723926|NCT00651261|3173749|Superiority or Other|||||||0.15|||||||Fisher Exact||||
1723929|NCT00650845|3173776|Superiority or Other|||||||0.051||||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||eGFR fluctuation in terms of percentage and mean difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the relative or absolute eGFR variation from baseline as a function of the MRI procedure with adjustment on centers.|
1723930|NCT00650845|3173777|Superiority or Other|||||||0.301||||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||eGFR fluctuation in terms of percentage and mean difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the relative or absolute eGFR variation from baseline as a function of the MRI procedure with adjustment on centers.|
1723931|NCT00650845|3173778|Superiority or Other|||||||0.04||||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||Serum creatinine level fluctuation in terms of difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the serum creatinine changes from baseline as a function of the MRI procedure with adjustment on centers.|
1723932|NCT00650845|3173779|Non-Inferiority or Equivalence|Assuming that in both MRI groups approximately 12% of the patients would have an increase in serum creatinine of at least 25% with respect to baseline values after imaging procedures, 120 evaluable patients (2 x 60) were needed to ensure with 80% power, at 5% one-sided significance level, that the difference between the two MRI procedures was less than 15% which was the non-inferiority clinical limit of the difference established for this study.|Mean Difference (Final Values)|-2.7|||||2-Sided|95.0|-14.1|8.9||||||The clinical non-inferiority limit of (non-enhanced - Dotarem®-enhanced) was fixed at -15%. The exact 95%CI of the difference (non-enhanced - Dotarem®-enhanced) was [-14.1%; +8.9%]|
1723933|NCT00650845|3173780|Superiority or Other|||||||0.291||||||p-value for main effect (difference between groups) adjusted on centers.|t-test, 2 sided|||Serum creatinine level fluctuation in terms of difference between baseline and 72 ±24hours after imaging procedure values was computed for both MRI procedures and compared between the 2 groups. A linear regression model was used to model the serum creatinine changes from baseline as a function of the MRI procedure with adjustment on centers.|
1723934|NCT00650845|3173781|Non-Inferiority or Equivalence|Assuming that in both MRI groups approximately 12% of the patients would have an increase in serum creatinine of at least 25% with respect to baseline values after imaging procedures, 120 evaluable patients (2 x 60) were needed to ensure with 80% power, at 5% one-sided significance level, that the difference between the two MRI procedures was less than 15% which was the non-inferiority clinical limit of the difference established for this study.|Mean Difference (Final Values)|-1.4|||||2-Sided|95.0|-7.9|6.7||||||The clinical non-inferiority limit of (non-enhanced - Dotarem®-enhanced) was fixed at -15%. The exact 95%Confidence Interval (CI) of the difference (non-enhanced - Dotarem®-enhanced) was [-7.9%; +6.7%]|
1723935|NCT00650806|3173782|Superiority or Other||Least-Squares Mean Difference|0.002|Standard Error of the Mean|0.0092||0.822|2-Sided|95.0|-0.016|0.0202|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.|||
1723936|NCT00650806|3173782|Superiority or Other||Least-Squares Mean Difference|0.001|Standard Error of the Mean|0.0095||0.9|2-Sided|95.0|-0.0174|0.0198|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.|||
1723937|NCT00650806|3173782|Superiority or Other||Least-Squares Mean Difference|0.011|Standard Error of the Mean|0.0091||0.239|2-Sided|95.0|-0.0071|0.0286|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.|||
1723938|NCT00650806|3173783|Superiority or Other||Least-Squares Mean Difference|-1.78|Standard Error of the Mean|1.15||0.121|2-Sided|95.0|-4.03|0.47|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.|||
1723939|NCT00650806|3173783|Superiority or Other||Least-Squares Mean Difference|-0.72|Standard Error of the Mean|1.18||0.541|2-Sided|95.0|-3.05|1.6|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.|||
1723940|NCT00650806|3173783|Superiority or Other||Least-Squares Mean Difference|-1.63|Standard Error of the Mean|1.13||0.149|2-Sided|95.0|-3.85|0.59|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.|||
1723941|NCT00650806|3173784|Superiority or Other||Least-Sqaures Mean Difference|-1.37|Standard Error of the Mean|1.25||0.273|2-Sided|95.0|-3.87|1.09|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.|||
1723942|NCT00650806|3173784|Superiority or Other||Least-Squares Mean Difference|-0.94|Standard Error of the Mean|1.29||0.466|2-Sided|95.0|-3.47|1.59|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.|||
1723943|NCT00650806|3173784|Superiority or Other||Least-Squares Mean Difference|-0.26|Standard Error of the Mean|1.23||0.835|2-Sided|95.0|-2.68|2.17|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.|||
1723944|NCT00650806|3173785|Superiority or Other|||||||0.317|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.|||
1723945|NCT00650806|3173785|Superiority or Other|||||||0.225|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.|||
1723946|NCT00650806|3173785|Superiority or Other|||||||0.117|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlled for run-in weight loss stratum and pooled center.|||
1723947|NCT00650806|3173786|Superiority or Other||Odds Ratio (OR)|3.1||||0.027|2-Sided|95.0|1.0|10.0||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.||
1723948|NCT00650806|3173786|Superiority or Other||Odds Ratio (OR)|2.9||||0.059|2-Sided|95.0|0.9|11.1||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.||
1723949|NCT00650806|3173786|Superiority or Other||Odds Ratio (OR)|1.7||||0.317||95.0|0.6|5.6||P-value controlled for run-in weight loss stratum and pooled center.|Cochran-Mantel-Haenszel||Odds ratio and Confidence Interval controlled for run-in weight loss stratum and pooled center.||
1723950|NCT00650806|3173787|Superiority or Other||Least-Squares Mean Difference|-0.48|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-0.76|-0.2|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.|||
1723951|NCT00650806|3173787|Superiority or Other||Least-Squares Mean Difference|-0.6|Standard Error of the Mean|0.15|<|0.001|2-Sided|95.0|-0.9|-0.32|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.|||
1723952|NCT00650806|3173787|Superiority or Other||Least-Squares Mean Difference|-0.31|Standard Error of the Mean|0.14|<|0.031|2-Sided|95.0|-0.59|-0.03|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. The corresponding baseline measurement was a covariate.|||
1723953|NCT00650806|3173788|Superiority or Other||Least-Squares Mean Difference|-1.3|Standard Error of the Mean|0.4||0.001|2-Sided|95.0|-2.07|-0.51|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.|||
1723954|NCT00650806|3173788|Superiority or Other||Least-Squares Mean Difference|-1.6|Standard Error of the Mean|0.41|<|0.001|2-Sided|95.0|-2.4|-0.8|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.|||
1723955|NCT00650806|3173788|Superiority or Other||Least-Squares Mean Difference|-0.8|Standard Error of the Mean|0.4|<|0.045|2-Sided|95.0|-1.58|-0.02|||ANCOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center. Baseline body weight was a covariate.|||
1723956|NCT00650806|3173789|Superiority or Other||Least-Squares Mean Difference|-1.4|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-2.1|-0.6|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.|||
1723957|NCT00650806|3173789|Superiority or Other||Least-Squares Mean Difference|-1.6|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-2.4|-0.8|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.|||
1723958|NCT00650806|3173789|Superiority or Other||Least-Squares Mean Difference|-0.9|Standard Error of the Mean|0.4|<|0.031|2-Sided|95.0|-1.6|-0.1|||ANOVA|Cofactors were treatment, run-in weight loss stratum, and pooled center.|||
1723959|NCT00650260|3173925|Superiority or Other|||||||1|||||||Fisher Exact||||
1723960|NCT00650260|3173928|Superiority or Other|||||||0.078|||||||t-test, 1 sided||||
1723961|NCT00650260|3173929|Superiority or Other|||||||0.027|||||||Fisher Exact||||
1723962|NCT00650078|3173946|Superiority or Other||Median Difference (Final Values)|-19.6||||0.0015|2-Sided|95.0|-31.7|-6.1||Wilcoxon Rank Sum Test p-value|Hodges-Lehman method|The difference between the treatment groups was assessed using the median and the 95% CI of the median computed using the Hodges Lehmann method.|||
1723963|NCT00650078|3173947|Superiority or Other||Odds Ratio (OR)|2.25||||0.001|2-Sided|95.0|1.39|3.64||The p-value was based on logistic regression with treatment, geographic region, gender, and median age class as factors.|Regression, Logistic||||
1723964|NCT00649428|3173954|Superiority or Other||||||<|1e-05|||||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.|
1723965|NCT00649428|3173957|Superiority or Other|||||||1e-05|||||||Cochran-Mantel-Haenszel|Stratified by combined treatment site.||A 5% level of significance was used as the threshold for determination of statistical significance, and all tests were two-tailed. the effect size and associated 95% confidence interval (CI) are provided for all comparative efficacy outcomes. Primary analysis of the two co-primary efficacy endpoints and the secondary efficacy endpoints were performed on the ITT population.|
1723966|NCT00649389|3173958|Superiority or Other||||||<|0.0001|||||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.|
1723967|NCT00649389|3173958|Superiority or Other||||||<|0.0001|||||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.|
1723968|NCT00649389|3173958|Superiority or Other||||||<|0.0001|||||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.|
1723969|NCT00649389|3173959|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.|
1723970|NCT00649389|3173959|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.|
1723971|NCT00649389|3173959|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Systolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.|
1724045|NCT00645099|3174156|Superiority or Other|||||||0.005|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).|||
1724490|NCT00635362|3175416|Superiority or Other|||||||0.37|||||||Fisher Exact||||
1723972|NCT00649389|3173959|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.|
1723973|NCT00649389|3173959|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.|
1723974|NCT00649389|3173959|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Diastolic blood pressure: All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.|
1723975|NCT00649389|3173960|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.|
1723976|NCT00649389|3173960|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.|
1723977|NCT00649389|3173960|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Each p-value was obtained from individual Cochran-Mantel-Haenszel tests stratified by age group, race group, and diabetic status comparing the triple combination therapy to each dual combination.|
1723978|NCT00649389|3173961|Superiority or Other||||||<|0.0001|||||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.|
1723979|NCT00649389|3173961|Superiority or Other||||||<|0.0001|||||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.|
1723980|NCT00649389|3173961|Superiority or Other||||||<|0.0001|||||||ANCOVA|||All treatment comparisons were calculated as OM40/AML10/HCTZ25 minus the respective dual combination treatment group. Least-squares mean differences, SEs, and 2-sided p-values were obtained from an ANCOVA model with baseline blood pressure as a covariate, and fixed effects of treatment, age group, race group, and diabetic status.|
1723981|NCT00649220|3173969|Superiority or Other|||||||0.34192|||||||Wilcoxon signed rank test|||Wilcoxon signed rank test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline|
1723982|NCT00649220|3173969|Superiority or Other|||||||0.22626|||||||t-test, 2 sided|||Two-side, paired t-test on the null hypothesis that antipsychotics are reduced by 10% compared to baseline|
1723983|NCT00648115|3173995|Superiority or Other||Pearson chi square|7.3|||<|0.05|2-Sided|95.0|||||Chi-squared||||
1723984|NCT00647348|3174020|Superiority|||||||0.05||||||EDSS,mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables.|ANCOVA|EDSS,mean score at 24 months was compared between treatment groups using an ANCOVA model adjusting for baseline score and minimisation variables.|||
1723985|NCT00647348|3174021|Other|intention-to-treat analysis||||||0.003|||||||BBSI=brain boundary shift integral||||
1723986|NCT00647270|3174022|Superiority or Other|||||||0.005||||||The ANCOVA Model was adjusted for Baseline Measure.|ANCOVA|The ANCOVA Model was adjusted for Baseline Measure.||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value > 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.|
1723987|NCT00647270|3174023|Superiority or Other|||||||0.002||||||The ANCOVA Model was adjusted for the Baseline Measure.|ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value > 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.|
1723988|NCT00647270|3174024|Superiority or Other|||||||0.002|||||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value > 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.|
1723989|NCT00647270|3174024|Superiority or Other|||||||0.005|||||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value > 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.|
1723990|NCT00647270|3174025|Superiority or Other|||||||0.002|||||||ANCOVA|||Using a fixed-sequence multiple-testing approach at an alpha level of 0.05 to test the secondary endpoints, the testing of the null-hypothesis began with the first endpoint and stopped as soon as failure to reject a hypothesis occurred (i.e., P value > 0.05). Using this procedure, testing stopped after secondary endpoint number 1, change from Baseline in HAQ at Week 12.|
1724015|NCT00645411|3174133|Non-Inferiority or Equivalence|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was >-10%.|Difference % (cTIV - eTIV)|-9.0|||||2-Sided|95.0|-13.0|-4.0||||||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.|
1723991|NCT00647270|3174026|Non-Inferiority or Equivalence|A sensitivity analysis was proposed for the non-inferiority comparison. If the lower confidence limit of θ80 - θ40 was greater than –0.1, then the non-inferiority of adalimumab 80 mg monthly to adalimumab 40 mg eow would be claimed||||||0.74||||||Non - inferiority of adalimumab 80 mg monthly compared with 40 mg eow could not be tested because the null hypothesis of the first comparison was not rejected.|Chi-squared|||The non-inferiority of adalimumab 80 mg monthly to adalimumab 40 mg every other week (eow) was to be claimed if at least 50% of the treatment effect of adalimumab 40 mg eow over placebo was to be achieved by adalimumab 80 mg monthly over placebo.|
1723992|NCT00647270|3174026|Superiority or Other||Mean Difference (Final Values)|-3.0||||0.074|2-Sided|95.0|-13.3|7.4|||Chi-squared||Treatment difference between adalimumab 80 mg monthly and placebo divided by the difference between adalimumab 40 mg eow and placebo.|Adalimumab 80 mg monthly versus placebo: The null hypothesis associated with this comparison stated that adalimumab 80 mg monthly would be inferior to placebo with respect to ACR20 response percentage; the alternative hypothesis was that adalimumab 80 mg monthly would be superior to placebo with respect to ACR20 response.|
1723993|NCT00646906|3174029|Superiority|An analysis of variance, appropriate for a three factor experiment with cohort and dose as non-repeated factors and repeated measure order arranged in a two period cross-over design, was performed.|||||>|0.05|||||||ANOVA||||
1723994|NCT00646906|3174030|Superiority|An analysis of variance, appropriate for a three factor experiment with cohort and dose as non-repeated factors and repeated measure order arranged in a two period cross-over design, was performed.|||||>|0.05|||||||ANOVA|||The primary hypothesis is that acetaminophen given two hours before aspirin will antagonize the effects of aspirin, while reversing the order of administration will not. Percent change from start (8:00 am on day 1) to finish (8:00 am on day 7) of period in serum thromboxane B2 for each order of drug administration will be primary endpoint of interest.|
1723995|NCT00646776|3174037|Superiority or Other||Point Estimate|2.19|||||2-Sided|90.0|1.783|2.691|||||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.||
1723996|NCT00646776|3174038|Superiority or Other||Point Estimate|11.451|||||2-Sided|90.0|8.147|16.095|||||||
1723997|NCT00646776|3174039|Superiority or Other||Point Estimate|7.766|||||2-Sided|90.0|6.133|9.833|||||||
1723998|NCT00646776|3174040|Superiority or Other||Point Estimate|10.902|||||2-Sided|90.0|8.135|14.61|||||||
1723999|NCT00646776|3174046|Superiority or Other||Point Estimate|0.696|||||2-Sided|90.0|0.563|0.862|||||||
1724000|NCT00646776|3174047|Superiority or Other||Point Estimate|0.651|||||2-Sided|90.0|0.43|0.986|||||||
1724001|NCT00646776|3174048|Superiority or Other||Point Estimate|0.66|||||2-Sided|90.0|0.538|0.809|||||||
1724002|NCT00646776|3174051|Superiority or Other||Point Estimate|0.857|||||2-Sided|90.0|0.723|1.015|||||||
1724003|NCT00646776|3174052|Superiority or Other||Point Estimate|0.745||||0.0963|2-Sided|90.0|0.5569|0.9967|||ANOVA||||
1724004|NCT00646776|3174053|Superiority or Other||Point Estimate|0.947|||||2-Sided|90.0|0.817|1.098|||||||
1724005|NCT00646776|3174054|Superiority or Other||Point Estimate|1.402|||||2-Sided|90.0|1.052|1.867|||||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.||
1724006|NCT00646776|3174055|Superiority or Other||Point Estimate|2.489|||||2-Sided|90.0|2.025|3.06|||||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.||
1724007|NCT00646776|3174056|Superiority or Other||Point Estimate|1.477|||||2-Sided|90.0|1.188|1.835|||||Point estimates and 90% confidence intervals of treatment differences on the log scale were exponentiated to obtain estimates on the original scale.||
1724008|NCT00645944|3174074|Superiority or Other||Mean Difference (Final Values)|-3.8||||0.039|2-Sided|95.0|-7.5|-0.2|||Mixed Models Analysis||||
1724009|NCT00645788|3174097|Superiority or Other|||||||0.068|||||||ANCOVA|||"At visit 7 (End of treatment) Ho: |Cipro 32.5 - matching placebo| =0 and~|Cipro 48.75 - matching placebo| =0"|
1724010|NCT00645788|3174099|Superiority or Other|||||||0.076|||||||ANCOVA|||"Ho: |Cipro 32.5 mg - matching placebo|=0 and |Cipro 48.75 mg - matching placebo|=0"|
1724011|NCT00645411|3174133|Non-Inferiority or Equivalence|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was >-10%.|Difference % (cTIV minus eTIV)|0.0|||||2-Sided|95.0|-6.0|6.0||||||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.|
1724012|NCT00645411|3174133|Non-Inferiority or Equivalence|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was >-10%.|Difference % (cTIV minus eTIV)|-5.0|||||2-Sided|95.0|-9.5|0.0||||||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.|
1724013|NCT00645411|3174133|Non-Inferiority or Equivalence|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was >-10%|Difference % (cTIV minus eTIV)|-1.0|||||2-Sided|95.0|-3.0|2.0||||||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.|
1724014|NCT00645411|3174133|Non-Inferiority or Equivalence|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was >-10%.|Difference % (cTIV minus eTIV)|-15.0|||||2-Sided|95.0|-21.0|-9.0||||||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI egg-derived antigen assay.|
1724042|NCT00645099|3174155|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).|||
1724016|NCT00645411|3174133|Non-Inferiority or Equivalence|cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was >-10%.|Difference in % (cTIV minus eTIV)|-1.0|||||2-Sided|95.0|-4.0|1.0||||||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay.|
1724017|NCT00645411|3174134|Non-Inferiority or Equivalence|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV)was >0.667.|Ratio of GMTs|0.87|||||2-Sided|95.0|0.71|1.06||||||Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.|
1724018|NCT00645411|3174134|Non-Inferiority or Equivalence|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was >0.667.|Ratio of GMTs|0.65|||||2-Sided|95.0|0.54|0.78||||||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.|
1724019|NCT00645411|3174134|Non-Inferiority or Equivalence|Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV) in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was >0.667.|Ratio of GMTs|0.92|||||2-Sided|95.0|0.79|1.08||||||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.|
1724020|NCT00645411|3174134|Non-Inferiority or Equivalence|Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was >0.667.|Ratio of GMTs|0.56|||||2-Sided|95.0|0.46|0.68||||||Non-inferiority of cTIV to eTIV against influenza B strain as measured by HI egg-derived antigen assay.|
1724021|NCT00645411|3174134|Non-Inferiority or Equivalence|Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV) in postvaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs(cTIV/eTIV) was >0.667.|Ratio of GMTs|0.59|||||2-Sided|95.0|0.49|0.72||||||Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.|
1724022|NCT00645411|3174134|Non-Inferiority or Equivalence|Cell derived vaccine was considered non-inferior to egg-derived vaccine in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was >0.667.|Ratio of GMTs|0.85|||||2-Sided|95.0|0.72|1.01||||||Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay|
1724023|NCT00645099|3174140|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.|
1724024|NCT00645099|3174140|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.|
1724025|NCT00645099|3174140|Non-Inferiority or Equivalence|Testing non-inferiority of the paliperidone ER treatment group compared to the olanzapine treatment group, with regard to change versus baseline at end point of the total PANSS was done by means of Schuirmann’s test. A difference of 6 points in change versus baseline on the total PANSS was considered to be a minimum clinically relevant difference.The null hypothesis is that there is no difference between paliperidone and olanzapine in change in TG:HDL ratio from baseline to endpoint.|||||<|0.0242|||||||Schuirmann|The null hypothesis of non-equivalence was rejected and equivalence to within the specified equivalence bounds could be claimed.|||
1724026|NCT00645099|3174141|Superiority or Other|||||||0.023|||||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).|||
1724027|NCT00645099|3174142|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).|||
1724028|NCT00645099|3174143|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).|||
1724029|NCT00645099|3174144|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.|
1724030|NCT00645099|3174144|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.|
1724031|NCT00645099|3174144|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).|||
1724032|NCT00645099|3174145|Superiority or Other|||||||0.3358|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).|||
1724033|NCT00645099|3174146|Superiority or Other|||||||0.1308|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).|||
1724034|NCT00645099|3174147|Superiority or Other|||||||0.677|||||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).|||
1724035|NCT00645099|3174148|Superiority or Other|||||||1|||||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).|||
1724036|NCT00645099|3174149|Superiority or Other|||||||0.6346|||||||Fisher Exact|This test was interpreted at the 5% significance level (2-tailed).|||
1724037|NCT00645099|3174150|Superiority or Other|||||||0.1117|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).|||
1724038|NCT00645099|3174151|Superiority or Other|||||||0.0325|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).|||
1724039|NCT00645099|3174152|Superiority or Other|||||||0.1892|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).|||
1724040|NCT00645099|3174153|Superiority or Other|||||||0.0272|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).|||
1724041|NCT00645099|3174154|Superiority or Other|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).|||
1724046|NCT00645099|3174157|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.|
1724047|NCT00645099|3174157|Superiority or Other||||||<|0.9143|||||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline to end point.|
1724048|NCT00645099|3174157|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).|||
1724049|NCT00645099|3174158|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group change from baseline at end point.|
1724050|NCT00645099|3174158|Superiority or Other||||||<|0.4718|||||||Wilcoxon signed rank test|This test was interpreted at the 5% significance level (2-tailed).||Within-group comparison of the change from baseline at end point.|
1724051|NCT00645099|3174158|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|This test was interpreted at the 5% significance level (2-tailed).||Based on available data it was estimated that in the paliperidone ER group the TG:HDL ratio would decrease with 0.15 and that the TG:HDL ratio would increase with 0.25 in the olanzapine group. The common SD of the change was estimated to be 1.4. A sample size of 205 patients in each treatment arm had 80% power to detect a difference of 0.4 in change of TG:HDL ratio after 6 months of treatment in favor of paliperidone ER treatment (Wilcoxon two-sample test with 0.05 two-sided significance level).|
1724052|NCT00644969|3174175|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.9022|2-Sided|95.0|-3.99|3.52|||ANCOVA||Least squares mean difference|Week 24 treatment difference|
1724053|NCT00644969|3174175|Superiority or Other||Mean Difference (Final Values)|-3.65||||0.0077|2-Sided|95.0|-6.32|-0.99|||ANCOVA||Least squares mean difference|Week 12 treatment difference|
1724054|NCT00644969|3174176|Superiority or Other||Odds Ratio (OR)|0.96||||0.9235|2-Sided|95.0|0.45|2.05|||Regression, Logistic|||Week 24|
1724055|NCT00644969|3174176|Superiority or Other||Odds Ratio (OR)|1.73||||0.1524|2-Sided|95.0|0.82|3.68|||Regression, Logistic|||Week 12|
1724056|NCT00644969|3174177|Superiority or Other||Odds Ratio (OR)|6.18||||0.0901|2-Sided|95.0|0.75|50.71|||Regression, Logistic||||
1724057|NCT00644969|3174178|Superiority or Other||Odds Ratio (OR)|4.74||||0.0457|2-Sided|95.0|1.03|21.78|||Regression, Logistic||||
1724058|NCT00644787|3174210|Non-Inferiority or Equivalence|Difference of 7.5 mm in VAS score was selected as the threshold value for clinical non-inferiority of Fentanyl 1-day transdermal patch to Fentanyl 3-day transdermal patch.|Mean Difference (Final Values)|1.4|||||2-Sided|95.0|-3.5|6.23|||||||
1724059|NCT00644592|3174214|Superiority or Other||Ratio of mean effects|1.27|Standard Error of the Mean|0.16||0.015|2-Sided|95.0|1.06|1.52|||t-test, 2 sided||The estimated mean log difference (SE) between the period 2 and period 1 effects and SE was estimated. This estimates twice the effect size[since (B-A)-(A-B)=2B-2A] so the actual estimate was based upon the antilog of half of this difference.|This is a crossover analysis. To convert to a ratio effect, the mean difference must be divided by two and antilogs take. The outcome represents a relative effect.|
1724060|NCT00644332|3174229|Superiority or Other||Mean Difference (Net)|2.9|Standard Error of the Mean|0.8|||||||||||||
1724061|NCT00644332|3174230|Superiority or Other||Mean Difference (Net)|-3.2|Standard Error of the Mean|0.5||||||||||||Mean change in NTG use from Baseline to Week 4|
1724062|NCT00644332|3174231|Superiority or Other||Mean Difference (Net)|-4.7|Standard Error of the Mean|0.5||||||||||||Mean change in angina frequency from Baseline to Week 4|
1724063|NCT00644228|3174238|Superiority or Other (legacy)|||||||0.2||||||The p-value is based on a stratified Cochran-Mantel-Haenszel test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Cochran-Mantel-Haenszel||||
1724064|NCT00644228|3174239|Superiority||Hazard Ratio (HR)|0.709||||0.025|2-Sided|95.0|0.524|0.959||The p-value is based on a two-sided, stratified log rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Log Rank||The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.|Overall survival will be compared between the two treatment arms using a stratified log-rank test.|
1724065|NCT00644228|3174240|Superiority||Hazard Ratio (HR)|0.712||||0.0018|2-Sided|96.0|0.56|0.906||The p-value is from a one-sided, stratified log-rank test. Stratification factors include those factors by which patients were randomized: intent to transplant (yes vs no) and ISS Stage (I vs II vs III).|Log Rank||The hazard ratio compares Bortezomib/Lenalidomide/Dexamethasone against Lenalidomide/Dexamethasone.|With four years of patient accrual and two and a half years of follow-up, 220 patients per arm yields 87% power to detect an increase of PFS of 50%, from a median of 3 years to 4.5 years, which corresponds to a hazard ratio of 1.5. These calculations are based on a one-sided stratified log-rank test at level 0.025 with two interim analyses. The final analysis will be carried out at the 0.02 significance level to allow for two interim analyses at the 0.0025 significance level.|
1724066|NCT00644059|3174257|Superiority or Other||GMT [B/Brisbane/2008]|1.08|||||2-Sided|95.0|1.0|1.17||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724067|NCT00644059|3174257|Superiority or Other||GMT [B/Brisbane/2008]|1.79|||||2-Sided|95.0|1.63|1.97||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724068|NCT00644059|3174257|Superiority or Other||GMT [B/Brisbane/2008]|1.13|||||2-Sided|95.0|1.05|1.22||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724069|NCT00644059|3174257|Superiority or Other||GMT [B/Brisbane/2008]|1.0|||||2-Sided|95.0|0.98|1.01||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724070|NCT00644059|3174257|Superiority or Other||GMT [A/Wisconsin/2009 (A/H3N2)]|2.66|||||2-Sided|95.0|2.0|3.55||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724491|NCT00635362|3175417|Superiority or Other|||||||1|||||||Fisher Exact||||
1724071|NCT00644059|3174257|Superiority or Other||GMT [A/Wisconsin/2009 (A/H3N2)]|7.36|||||2-Sided|95.0|5.51|9.82||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724072|NCT00644059|3174257|Superiority or Other||GMT [A/Wisconsin/2009 (A/H3N2)]|3.14|||||2-Sided|95.0|2.19|4.49||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724073|NCT00644059|3174257|Superiority or Other||GMT [A/Wisconsin/2009 (A/H3N2)]|0.98|||||2-Sided|95.0|0.74|1.3||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724074|NCT00644059|3174257|Superiority or Other||GMT [A/Solomon Islands/2006 (A/H1N1)]|3.11|||||2-Sided|95.0|2.3|4.2||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724075|NCT00644059|3174257|Superiority or Other||GMT [A/Solomon Islands/2006 (A/H1N1)]|5.58|||||2-Sided|95.0|4.08|7.63||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724076|NCT00644059|3174257|Superiority or Other||GMT [A/Solomon Islands/2006 (A/H1N1)]|1.72|||||2-Sided|95.0|1.17|2.51||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724077|NCT00644059|3174257|Superiority or Other||GMT [A/Solomon Islands/2006 (A/H1N1)]|0.96|||||2-Sided|95.0|0.75|1.22||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724078|NCT00644059|3174257|Superiority or Other||GMT [B/Florida/2006]|2.55|||||2-Sided|95.0|2.22|2.93||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724079|NCT00644059|3174257|Superiority or Other||GMT [B/Florida/2006]|5.0|||||2-Sided|95.0|4.25|5.88||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724080|NCT00644059|3174257|Superiority or Other||GMT [B/Florida/2006]|1.56|||||2-Sided|95.0|1.26|1.93||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724081|NCT00644059|3174257|Superiority or Other||GMT [B/Florida/2006]|0.97|||||2-Sided|95.0|0.9|1.05||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724082|NCT00644059|3174257|Superiority or Other||GMT [A/Brisbane/2007 (A/H3N2)]|3.13|||||2-Sided|95.0|2.42|4.05||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724083|NCT00644059|3174257|Superiority or Other||GMT [A/Brisbane/2007 (A/H3N2)]|7.98|||||2-Sided|95.0|6.2|10.0||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724084|NCT00644059|3174257|Superiority or Other||GMT [A/Brisbane/2007 (A/H3N2)]|6.42|||||2-Sided|95.0|4.72|8.73||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724085|NCT00644059|3174257|Superiority or Other||GMT [A/Brisbane/2007 (A/H3N2)]|1.05|||||2-Sided|95.0|0.82|1.35||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of Geometric Mean Titers GMTs in subjects aged 6 to <72 months by HI assay.|
1724086|NCT00644059|3174257|Superiority or Other||GMT [A/Brisbane/2007 (A/H1N1)]|4.37|||||2-Sided|95.0|3.38|5.65||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724087|NCT00644059|3174257|Superiority or Other||GMT [A/Brisbane/2007 (A/H1N1)]|8.26|||||2-Sided|95.0|6.36|11.0||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724088|NCT00644059|3174257|Superiority or Other||GMT [A/Brisbane/2007 (A/H1N1)]|6.41|||||2-Sided|95.0|4.69|8.76||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724089|NCT00644059|3174257|Superiority or Other||GMT [A/Brisbane/2007 (A/H1N1)]|0.96|||||2-Sided|95.0|0.78|1.19||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to <72 months by HI assay.|
1724090|NCT00644059|3174260|Superiority or Other||GMT [B/Brisbane/2008]|1.0|||||2-Sided|95.0|0.92|1.08||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724091|NCT00644059|3174260|Superiority or Other||GMT [B/Brisbane/2008]|1.74|||||2-Sided|95.0|1.57|1.92||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724092|NCT00644059|3174260|Superiority or Other||GMT [B/Brisbane/2008]|1.06|||||2-Sided|95.0|1.02|1.11||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724093|NCT00644059|3174260|Superiority or Other||GMT [B/Brisbane/2008]|1.0|||||2-Sided|95.0|1.0|1.0||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724485|NCT00635492|3175399|Superiority or Other||Odds Ratio (OR)|1.05||||0.0083|2-Sided|95.0|1.01|1.1|||Regression, Logistic|||Diabetes Health Profile - 18 (DHP-18) subscale disinhibited eating - Yes vs. No|
1724094|NCT00644059|3174260|Superiority or Other||GMT [A/Wisconsin/2009 (A/H3N2)]|3.6|||||2-Sided|95.0|2.61|4.95||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724095|NCT00644059|3174260|Superiority or Other||GMT [A/Wisconsin/2009 (A/H3N2)]|13.0|||||2-Sided|95.0|10.0|16.0||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724096|NCT00644059|3174260|Superiority or Other||GMT[A/Wisconsin/2009 (A/H3N2)]|3.54|||||2-Sided|95.0|2.78|4.51||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724097|NCT00644059|3174260|Superiority or Other||GMT [A/Wisconsin/2009 (A/H3N2)]|0.9|||||2-Sided|95.0|0.74|1.1||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724098|NCT00644059|3174260|Superiority or Other||GMT[A/Solomon Islands/2006 (A/H1N1)]|3.31|||||2-Sided|95.0|2.4|4.55||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724099|NCT00644059|3174260|Superiority or Other||GMT [A/Solomon Islands/2006 (A/H1N1]|7.54|||||2-Sided|95.0|5.33|11.0||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724100|NCT00644059|3174260|Superiority or Other||GMT[A/Solomon Islands/2006 (A/H1N1)]|1.21|||||2-Sided|95.0|0.83|1.78||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724101|NCT00644059|3174260|Superiority or Other||GMT [A/Solomon Islands/2006 (A/H1N1)]|0.81|||||2-Sided|95.0|0.64|1.04||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724102|NCT00644059|3174260|Superiority or Other||GMT[B/Florida/2006]|2.92|||||2-Sided|95.0|2.44|3.5||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724103|NCT00644059|3174260|Superiority or Other||GMT[B/Florida/2006]|6.99|||||2-Sided|95.0|5.72|8.53||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724104|NCT00644059|3174260|Superiority or Other||GMT[B/Florida/2006]|1.5|||||2-Sided|95.0|1.19|1.9||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724105|NCT00644059|3174260|Superiority or Other||GMT[B/Florida/2006]|1.0|||||2-Sided|95.0|0.91|1.1||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724106|NCT00644059|3174260|Superiority or Other||GMT[A/Brisbane/2007 (A/H3N2)]|4.92|||||2-Sided|95.0|3.64|6.65||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724107|NCT00644059|3174260|Superiority or Other||GMT[A/Brisbane/2007 (A/H3N2)]|16.0|||||2-Sided|95.0|12.0|20.0||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724108|NCT00644059|3174260|Superiority or Other||GMT[A/Brisbane/2007 (A/H3N2)]|9.82|||||2-Sided|95.0|7.76|12.0||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724109|NCT00644059|3174260|Superiority or Other||GMT[A/Brisbane/2007 (A/H3N2)]|1.01|||||2-Sided|95.0|0.85|1.21||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724110|NCT00644059|3174260|Superiority or Other||GMT[A/Brisbane/2007 (A/H1N1)]|6.48|||||2-Sided|95.0|4.83|8.68||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to <36 months by HI assay|
1724111|NCT00644059|3174260|Superiority or Other||GMT[A/Brisbane/2007 (A/H1N1)]|15.0|||||2-Sided|95.0|11.0|21.0||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to <36 months by HI assay|
1724112|NCT00644059|3174260|Superiority or Other||GMT[A/Brisbane/2007 (A/H1N1)]|7.63|||||2-Sided|95.0|5.42|11.0||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724113|NCT00644059|3174260|Superiority or Other||GMT[A/Brisbane/2007 (A/H1N1)]|0.83|||||2-Sided|95.0|0.67|1.02||||||To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to <36 months by HI assay.|
1724114|NCT00644059|3174266|Superiority or Other||Vaccine Efficacy|85.66|||||2-Sided|95.0|58.95|94.99||||||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.|
1724115|NCT00644059|3174266|Superiority or Other||Vaccine Efficacy|64.16|||||2-Sided|95.0|23.21|83.28||||||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.|
1724198|NCT00642278|3174482|Superiority or Other||Least-Sqaures Mean Difference|-1.3|Standard Error of the Mean|0.5|<|0.009|2-Sided|95.0|-2.2|-0.3|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724116|NCT00644059|3174266|Superiority or Other||Vaccine Efficacy|92.1|||||2-Sided|95.0|77.35|97.24||||||Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza. Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)|
1724117|NCT00644059|3174266|Superiority or Other||vaccine Efficacy|79.18|||||2-Sided|95.0|54.78|90.42||||||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"|
1724118|NCT00644059|3174267|Superiority or Other||Vaccine Efficacy|0.09|||||2-Sided|95.0|0.02|0.38||||||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.|
1724119|NCT00644059|3174267|Superiority or Other||Vaccine Efficacy|0.32|||||2-Sided|95.0|0.13|0.73||||||Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.|
1724120|NCT00644059|3174267|Superiority or Other||Vaccine Efficacy|95.5|||||2-Sided|95.0|80.92|98.94||||||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"|
1724121|NCT00644059|3174267|Superiority or Other||Vaccine Efficacy|81.36|||||2-Sided|95.0|49.24|93.16||||||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"|
1724122|NCT00644059|3174270|Superiority or Other||Vaccine Efficacy|81.36|||||2-Sided|97.66|49.24|93.16||||||"Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)"|
1724123|NCT00643851|3174277|Superiority or Other||Mean Difference (Final Values)|-1.57|Standard Error of the Mean|0.4201|||2-Sided|95.0|-2.4|-0.74|||||||
1724124|NCT00643851|3174277|Superiority or Other||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.4191|||2-Sided|95.0|-0.98|0.66|||||||
1724125|NCT00643851|3174278|Superiority or Other||Mean Difference (Final Values)|-1.37|Standard Error of the Mean|0.3399|<|0.0001|2-Sided|95.0|-2.04|-0.71||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA||||
1724126|NCT00643851|3174278|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.3388|<|0.8769|2-Sided|95.0|-0.72|0.61||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA||||
1724127|NCT00643851|3174279|Superiority or Other||Mean Difference (Final Values)|-1.19|Standard Error of the Mean|0.1912|<|0.0001|2-Sided|95.0|-1.57|-0.82||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA||||
1724128|NCT00643851|3174279|Superiority or Other||Mean Difference (Final Values)|-1.34|Standard Error of the Mean|0.1938|<|0.0001|2-Sided|95.0|-1.72|-0.96||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA||||
1724129|NCT00643851|3174280|Superiority or Other||Mean Difference (Final Values)|17.8|Standard Error of the Mean|4.947||0.0003|2-Sided|95.0|8.1|27.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA||||
1724130|NCT00643851|3174280|Superiority or Other||Mean Difference (Final Values)|29.9|Standard Error of the Mean|4.633|<|0.0001|2-Sided|95.0|20.8|39.0||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|modified logistic regression||||
1724131|NCT00643851|3174281|Superiority or Other||Mean Difference (Final Values)|-27.5|Standard Error of the Mean|3.897|<|0.0001|2-Sided|95.0|-35.1|-19.8||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA||||
1724132|NCT00643851|3174281|Superiority or Other||Mean Difference (Final Values)|-19.1|Standard Error of the Mean|3.883|<|0.0001|2-Sided|95.0|-26.7|-11.4||Secondary endpoints were tested following a sequential testing procedure at alpha=0.05. Significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA||||
1724133|NCT00643851|3174282|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.1245|<|0.0001|2-Sided|95.0|-0.94|-0.45||Primary endpoint was tested at alpha=0.05; significance was claimed only if DAPA 5MG + MET is superior to both controls.|ANCOVA||||
1724134|NCT00643851|3174282|Superiority or Other||Mean Difference (Final Values)|-0.86|Standard Error of the Mean|0.1243|<|0.0001|2-Sided|95.0|-1.11|-0.62||Primary endpoint was tested at alpha=0.05; significance was claimed only if DAPA 5MG + MET was superior to both controls.|ANCOVA||||
1724135|NCT00643760|3174301|Superiority or Other||Adjusted mean difference versus placebo|0.43||||||95.0|-0.22|1.08|||||||
1724492|NCT00635362|3175418|Superiority or Other|||||||0.04|||||||Fisher Exact||||
1724136|NCT00643760|3174301|Superiority or Other||Adjusted mean difference versus placebo|-0.55||||0.105||95.0|-1.1|0.01||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used.|||
1724137|NCT00643760|3174301|Superiority or Other||Adjusted mean difference versus placebo|-0.02||||0.946||95.0|-0.71|0.66||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used.|||
1724138|NCT00643760|3174301|Superiority or Other||Adjusted mean difference versus placebo|-0.35||||0.295||95.0|-1.02|0.31||This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|Analysis of covariance (ANCOVA) model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.|||
1724139|NCT00643604|3174307|Superiority or Other|||||||1|||||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724140|NCT00643604|3174308|Superiority or Other|||||||1|||||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724141|NCT00643604|3174309|Superiority or Other|||||||1|||||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724142|NCT00643604|3174310|Superiority or Other|||||||0.5|||||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724143|NCT00643604|3174311|Superiority or Other|||||||1|||||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724144|NCT00643604|3174312|Superiority or Other|||||||0.25|||||||Wilcoxon sign-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724145|NCT00643604|3174313|Superiority or Other|||||||0.5|||||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724146|NCT00643604|3174314|Superiority or Other|||||||0.13|||||||Wilcoxon signed-rank test|||Total Time. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724147|NCT00643604|3174314|Superiority or Other|||||||0.88|||||||Wilcoxon signed-rank test|||Change Dressing. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724148|NCT00643604|3174314|Superiority or Other|||||||0.63|||||||Wilcoxon signed-rank test|||Connect Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724149|NCT00643604|3174314|Superiority or Other|||||||0.06|||||||Wilcoxon signed-rank test|||Prepare Drug. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724150|NCT00643604|3174314|Superiority or Other|||||||0.25|||||||Wilcoxon signed-rank test|||Gather/Set-up. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724151|NCT00643604|3174315|Superiority or Other|||||||0.88|||||||Wilcoxon signed-rank test|||Global Satisfaction Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724152|NCT00643604|3174315|Superiority or Other|||||||0.03|||||||Wilcoxon signed-rank test|||Convenience Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724153|NCT00643604|3174315|Superiority or Other|||||||0.19|||||||Wilcoxon signed-rank test|||Side-Effects Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724154|NCT00643604|3174315|Superiority or Other|||||||0.19|||||||Wilcoxon signed-rank test|||Effectiveness Score Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724155|NCT00643604|3174316|Superiority or Other|||||||0.13|||||||Wilcoxon signed-rank test|||"Total Score N=5; Baseline Activity component score could not be calculated for one subject. Total Score could not be calculated for this subject.~Wilcoxon signed rank test was used to compare the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values."|
1724156|NCT00643604|3174316|Superiority or Other|||||||0.31|||||||Wilcoxon signed-rank test|||Quality of Life Score. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724199|NCT00642278|3174484|Superiority or Other||Least-Squares Mean Difference|-3.3|Standard Error of the Mean|5.09||0.513|2-Sided|95.0|-13.33|6.67|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724157|NCT00643604|3174316|Superiority or Other|||||||1||||||p value for Activity Score.|Wilcoxon signed rank test|||Activity Score N=5; Baseline component score could not be calculated for one subject. Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724158|NCT00643604|3174316|Superiority or Other|||||||0.03||||||p value for Symptom Score|Wilcoxon signed rank test|||Changes in mean CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724159|NCT00643604|3174317|Superiority or Other|||||||0.13|||||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724160|NCT00643604|3174318|Superiority or Other|||||||1|||||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724161|NCT00643604|3174319|Superiority or Other|||||||0.69|||||||Wilcoxon signed-rank test|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1724162|NCT00643565|3174326|Superiority||Hazard Ratio (HR)|0.8||||0.3211|2-Sided|95.0|0.51|1.25|||Log Rank|||The HR was calculated based on a stratified Cox proportional hazards model, with stratification factors of age and histology/disease risk.|
1724163|NCT00643565|3174327|Superiority or Other (legacy)||Hazard Ratio (HR)|0.93||||0.7189|2-Sided|95.0|0.61|1.41|||Log Rank|||The HR was calculated based on a stratified Cox proportional hazards model, with stratification factors of age and histology/disease risk.|
1724164|NCT00643279|3174345|Superiority|Survival estimate at 6-months|6-month survival rate|100.0|||||1-Sided|95.0|98.9||||||||
1724165|NCT00643279|3174346|Superiority|Survival estimate at 6-months|6-month survival rate|91.5|||||1-Sided|95.0|88.7||||||||
1724166|NCT00643201|3174353|Superiority or Other||Risk Ratio (RR)|0.5937|||<|0.0001|2-Sided|95.0|0.5318|0.6629||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.|
1724167|NCT00643201|3174354|Superiority or Other||Risk Ratio (RR)|0.6182|||<|0.0001|2-Sided|95.0|0.5432|0.7034||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.|
1724168|NCT00643201|3174355|Superiority or Other||Risk Ratio (RR)|0.4793|||<|0.0001|2-Sided|95.0|0.3815|0.6022||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.|
1724169|NCT00643201|3174356|Superiority or Other||Risk Ratio (RR)|0.441|||<|0.0001|2-Sided|95.0|0.3566|0.5453||Tested at 2-sided alpha=0.05 significance.|Cochran-Mantel-Haenszel|Nominal p-value is reported.|Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. Inferential testing was not conducted because the null hypothesis pertaining to superiority for VTE/VTE-related death was not rejected.|
1724170|NCT00643201|3174357|Superiority or Other||Risk Ratio (RR)|0.307|||<|0.0001|2-Sided|95.0|0.1728|0.5452||p-value calculated on the CMH test stratified by index event strata.|Cochran-Mantel-Haenszel||Relative risk and CI were calculated based on CMH test stratified by index event strata.|Hypothesis: apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. As per the hierarchical statistical testing cascade, inferential testing for adjudicated major bleeding occurred because non-inferiority for VTE/VTE-related death (Primary efficacy endpoint) was demonstrated earlier. Rejection of the null hypothesis for equivalence for major bleeding allowed inferential testing for superiority of VTE/VTE-related death.|
1724171|NCT00643201|3174358|Superiority or Other||Risk Ratio (RR)|0.7934|||||2-Sided|95.0|0.5287|1.1906|||||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.|
1724172|NCT00643201|3174359|Superiority or Other||Risk Ratio (RR)|0.6539|||||2-Sided|95.0|0.3419|1.2508|||||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.|
1724173|NCT00643201|3174360|Superiority or Other||Risk Ratio (RR)|0.7521|||||2-Sided|95.0|0.356|1.5889|||||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.|
1724174|NCT00643201|3174361|Superiority or Other||Risk Ratio (RR)|1.0935|||||2-Sided|95.0|0.6363|1.8793|||||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.|
1724175|NCT00643201|3174362|Superiority or Other||Risk Ratio (RR)|0.6347|||||2-Sided|95.0|0.3735|1.0787|||||Relative Risk and CI was calculated based on CMH test stratified by index event strata.|Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.|
1724176|NCT00643201|3174363|Superiority or Other||Risk Ratio (RR)|0.5532|||<|0.0001|2-Sided|95.0|0.4658|0.6569||The test was stratified by index event strata using alpha=0.05 level of significance. Nominal p-value is reported.|Cochran-Mantel-Haenszel|||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.|
1724177|NCT00643201|3174364|Superiority or Other||Risk Ratio (RR)|0.6236||||0.0011|2-Sided|95.0|0.4682|0.8306||The test was stratified by index event strata using alpha=0.05 level of significance. Nominal p-value is reported.|Cochran-Mantel-Haenszel|||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.|
1724279|NCT00640510|3174650|Superiority or Other|||||||1|||||||Fisher Exact||||
1724178|NCT00643201|3174365|Superiority or Other||Risk Ratio (RR)|0.7994||||0.1848|2-Sided|95.0|0.5737|1.1137||The test was stratified by index event strata using alpha=0.05 level of significance. . Nominal p-value is reported.|Cochran-Mantel-Haenszel|Analysis was performed on the secondary efficacy dataset; there was no imputation of missing data.||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.|
1724179|NCT00643201|3174366|Superiority or Other||Risk Ratio (RR)|0.8151||||0.1554|2-Sided|95.0|0.6146|1.0812||The test was stratified by index event strata using alpha=0.05 level of significance. Analysis was performed on the secondary efficacy dataset; there was no imputation of missing data.|Cochran-Mantel-Haenszel|Nominal p-value is reported.||Exploratory hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint.|
1724180|NCT00643201|3174367|Superiority or Other||Risk Ratio (RR)|0.839||||0.3128|2-Sided|95.0|0.5965|1.1802||Tested at 2-sided α=0.05 significance. Further inferential statistical testing halted due to failure to reject the null hypothesis of equivalence for VTE/VTE-related death.|Cochran-Mantel-Haenszel|Relative risk, CI, and p-value were calculated based on CMH test stratified by index event strata.||Hypothesis of apixaban therapy being superior to enoxaparin/warfarin therapy for the adjudicated endpoint. Inferential testing required demonstration of non-inferiority using both RR and RD plus demonstration of superiority for major bleeding.|
1724181|NCT00643201|3174367|Non-Inferiority or Equivalence|Statistical Testing; non-inferiority tested at 1-sided α=0.025. If non-inferiority demonstrated for both RR and RD, the primary objective was achieved.|Risk Difference (RD)|-0.0044|||<|0.0001|2-Sided|95.0|-0.0128|0.004||Yanagawa-Tango-Hiejima test statistic for risk difference (RD).|Yanagawa-Tango-Hiejima|||Hypothesis that apixaban was non-inferior to enoxaparin/warfarin therapy in preventing the recurrence of VTE (nonfatal DVT or nonfatalPE)/VTE-related death as measured by risk difference.|
1724182|NCT00643201|3174367|Non-Inferiority or Equivalence|Statistical Testing: non-inferiority tested at 1-sided α=0.025 with margin of 1.8. Demonstration of non-inferiority using both relative risk (RR) (margin = 1.8) and risk difference (RD) (margin = 0.035) were required to achieve the primary objective.|Risk Ratio (RR)|0.839|||<|0.0001|2-Sided|95.0|0.5965|1.1802||This is the first test in a sequential testing sequence. p-value calculated based on the Yanagawa-Tango-Hiejima test stratified by index event strata for non-inferiority. Tested at 1-sided α=0.025|Yanagawa-Tango-Hiejima|For a successful trial; rejection of the null hypotheses for both RR and RD was required.||Hypothesis that apixaban was non-inferior to enoxaparin/warfarin therapy in preventing the recurrence of VTE (nonfatal DVT or nonfatal PE)/VTE-related death.|
1724183|NCT00643162|3174370|Other||Mean Difference (Final Values)|2.3|Standard Deviation|6.15||0.68|2-Sided||||||t-test, 2 sided||||
1724184|NCT00643123|3174372|Other||Mean Difference (Final Values)|2.9|Standard Error of the Mean|2.3||0.45|2-Sided||||||t-test, 2 sided||||
1724185|NCT00642993|3174379|Superiority or Other||Mean Difference (Final Values)|0.13||||0.231|2-Sided|95.0|-0.09|0.35|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.|||
1724186|NCT00642993|3174380|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.543|2-Sided|95.0|-1.2|0.63|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.|||
1724187|NCT00642993|3174381|Superiority or Other||Odds Ratio (OR)|1.55||||0.515|2-Sided|95.0|0.24|9.93|||Cochran-Mantel-Haenszel|The p-value is from the Cochran-Mantel-Haenszel Test adjusting for gender.|||
1724188|NCT00642993|3174382|Superiority or Other||Odds Ratio (OR)|0.58||||0.14|2-Sided|95.0|0.28|1.2|||Cochran-Mantel-Haenszel|The P-value is from the Cochran-Mantel-Haenszel Test adjusting for gender.|||
1724189|NCT00642993|3174383|Superiority or Other||Difference in means|0.41||||0.187|2-Sided|95.0|-0.2|1.03|||ANOVA|Mean and standard error are least squares means and corresponding standard errors based on an ANOVA model with main effects for treatment.|||
1724190|NCT00642694|3174418|Superiority|||||||0.05|||||||Mixed Models Analysis||||
1724191|NCT00642642|3174426|Superiority or Other||||||<|0.0001||||||a priori threshold for statistical significance = 0.05|McNemar|paired test of proportions||"Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar’s paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks & 50% correlation between endpoints"|
1724192|NCT00642642|3174427|Superiority or Other|||||||0.0109||||||a priori threshold for statistical significance was 0.05|McNemar|Paired test of proportions||"Null hypothesis: no difference in the response rates between the two treatment arms.~Statistical test: McNemar’s paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.~Assumptions for power calculations:~Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks & 50% correlation between endpoints"|
1724193|NCT00642278|3174482|Superiority or Other||Least-Sqaures Mean Difference|0.4|Standard Error of the Mean|0.5||0.371|2-Sided|95.0|-0.5|1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724194|NCT00642278|3174482|Superiority or Other||Least-Sqaures Mean Difference|-2.3|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|-3.3|-1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724195|NCT00642278|3174482|Superiority or Other||Least-Sqaures Mean Difference|-2.3|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|-3.3|-1.4|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724196|NCT00642278|3174482|Superiority or Other||Least-Sqaures Mean Difference|-1.6|Standard Error of the Mean|0.5|<|0.001|2-Sided|95.0|-2.6|-0.7|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and mixed meal tolerance test.|||
1724197|NCT00642278|3174482|Superiority or Other||Least-Sqaures Mean Difference|-1.5|Standard Error of the Mean|0.5|<|0.002|2-Sided|95.0|-2.5|-0.6|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724493|NCT00635362|3175419|Superiority or Other|||||||0.35|||||||Fisher Exact||||
1724200|NCT00642278|3174484|Superiority or Other||Least-Sqaures Mean Difference|60.3|Standard Error of the Mean|5.13|<|0.001|2-Sided|95.0|50.17|70.35|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724201|NCT00642278|3174484|Superiority or Other||Least-Squares Mean Difference|49.0|Standard Error of the Mean|5.11|<|0.001|2-Sided|95.0|38.91|59.01|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724202|NCT00642278|3174484|Superiority or Other||Least-Sqaures Mean Difference|48.2|Standard Error of the Mean|5.2|<|0.001|2-Sided|95.0|37.98|58.42|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724203|NCT00642278|3174484|Superiority or Other||Least-Sqaures Mean Difference|49.3|Standard Error of the Mean|5.13|<|0.001|2-Sided|95.0|39.17|59.34|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724204|NCT00642278|3174484|Superiority or Other||Least-Sqaures Mean Difference|36.1|Standard Error of the Mean|5.1|<|0.001|2-Sided|95.0|26.07|46.13|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724205|NCT00642278|3174486|Superiority or Other||Least-Squares Mean Difference|-1.0|Standard Error of the Mean|0.27|<|0.001|2-Sided|95.0|-1.51|-0.46|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724206|NCT00642278|3174486|Superiority or Other||Least-Squares Mean Difference|-1.7|Standard Error of the Mean|0.27|<|0.001|2-Sided|95.0|-2.25|-1.19|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724207|NCT00642278|3174486|Superiority or Other||Least-Squares Mean Difference|-1.8|Standard Error of the Mean|0.27|<|0.001|2-Sided|95.0|-2.32|-1.26|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724208|NCT00642278|3174486|Superiority or Other||Least-Squares Mean Difference|-1.8|Standard Error of the Mean|0.27|<|0.001|2-Sided|95.0|-2.33|-1.27|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724209|NCT00642278|3174486|Superiority or Other||Least-Squares Mean Difference|-1.4|Standard Error of the Mean|0.27|<|0.001|2-Sided|95.0|-1.98|-0.92|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724210|NCT00642278|3174486|Superiority or Other||Least-Squares Mean Difference|-0.9|Standard Error of the Mean|0.27|<|0.001|2-Sided|95.0|-1.39|-0.34|||ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724211|NCT00642278|3174487|Superiority or Other||Least-Squares Mean Difference|-0.56|Standard Error of the Mean|0.116|<|0.001|2-Sided|95.0|-0.862|-0.265||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724212|NCT00642278|3174487|Superiority or Other||Least-Squares Mean Difference|-0.73|Standard Error of the Mean|0.116|<|0.001|2-Sided|95.0|-1.029|-0.432||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724213|NCT00642278|3174487|Superiority or Other||Least-Squares Mean Difference|-0.71|Standard Error of the Mean|0.117|<|0.001|2-Sided|95.0|-1.006|-0.405||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724214|NCT00642278|3174487|Superiority or Other||Least-Squares Mean Difference|-0.54|Standard Error of the Mean|0.116|<|0.001|2-Sided|95.0|-0.841|-0.244||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724215|NCT00642278|3174487|Superiority or Other||Least-Squares Mean Difference|-0.51|Standard Error of the Mean|0.116|<|0.001|2-Sided|95.0|-0.804|-0.207||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724216|NCT00642278|3174487|Superiority or Other||Least-Squares Mean Difference|-0.45|Standard Error of the Mean|0.116|<|0.001|2-Sided|95.0|-0.747|-0.148||Adjusted using Dunnett's procedure.|ANCOVA|ANCOVA model included terms for treatment, baseline value, and stratification factor (participation in mixed meal tolerance test).|||
1724217|NCT00642174|3174488|Superiority or Other||Mean Difference (Net)|-2.6||||0.3725||95.0|-8.46|3.26||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).|
1724218|NCT00642174|3174488|Superiority or Other||Mean Difference (Net)|-19.9|||<|0.0001||95.0|-24.97|-14.9||P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).|
1724219|NCT00642174|3174488|Superiority or Other||Mean Difference (Net)|-23.9|||<|0.0001||95.0|-29.67|-18.11||P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).|
1724280|NCT00640510|3174651|Superiority or Other|||||||0.756||||||P-value for Change from Baseline to 90 minutes. Change = Timepoint minus baseline.|t-test, 2 sided||||
1724220|NCT00642174|3174488|Superiority or Other||Mean Difference (Net)|-16.2|||<|0.0001||95.0|-21.15|-11.33||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).|
1724221|NCT00642174|3174488|Superiority or Other||Mean Difference (Net)|-1.3|||<|0.5238||95.0|-5.35|2.78||P-value for Baseline. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate (ADP).|
1724222|NCT00642174|3174489|Superiority or Other||Mean Difference (Net)|-14.9||||0.0012||95.0|-23.42|-6.37||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set to p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.|
1724223|NCT00642174|3174489|Superiority or Other||Mean Difference (Net)|-42.8|||<|0.0001||95.0|-50.03|-35.55||P-value for 24 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.|
1724224|NCT00642174|3174489|Superiority or Other||Mean Difference (Net)|-53.0|||<|0.0001||95.0|-61.89|-44.02||P-value for 4 Hours After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.|
1724225|NCT00642174|3174489|Superiority or Other||Mean Difference (Net)|-36.2|||<|0.0001||95.0|-47.43|-24.98||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.|
1724226|NCT00642174|3174489|Superiority or Other||Mean Difference (Net)|2.9|||<|0.3692||95.0|-3.6|9.44||P-value for Baseline. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in Inhibition of Platelet Function as assessed by VASP.|
1724227|NCT00642174|3174490|Superiority or Other||Mean Difference (Net)|-12.4|||<|0.0001||95.0|-17.19|-7.58||P-value for 24 Hour After Last Maintenance Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).|
1724228|NCT00642174|3174490|Superiority or Other||Mean Difference (Net)|-31.0|||<|0.0001||95.0|-36.32|-25.66||P-value for 24 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).|
1724229|NCT00642174|3174490|Superiority or Other||Mean Difference (Net)|-35.1|||<|0.0001||95.0|-40.32|-29.78||P-value for 4 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).|
1724230|NCT00642174|3174490|Superiority or Other||Mean Difference (Net)|-25.2|||<|0.0001||95.0|-32.43|-17.87||P-value for 1 Hour After Loading Dose (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).|
1724231|NCT00642174|3174490|Superiority or Other||Mean Difference (Net)|0.2|||<|0.8779||95.0|-2.8|3.26||P-value for Baseline (20 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).|
1724281|NCT00640510|3174651|Superiority or Other|||||||0.784||||||P-value for Change from Baseline to 60 minutes. Change = Timepoint minus baseline.|t-test, 2 sided||||
1724282|NCT00640510|3174651|Superiority or Other|||||||0.62||||||P-value for Change from Baseline to 30 minutes. Change = Timepoint minus baseline.|t-test, 2 sided||||
1724232|NCT00642174|3174490|Superiority or Other||Mean Difference (Net)|-8.7|||<|0.0001||95.0|-12.78|-4.58||P-value for 24 Hour After Last Maintenance Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).|
1724233|NCT00642174|3174490|Superiority or Other||Mean Difference (Net)|-23.3|||<|0.0001||95.0|-27.42|-19.17||P-value for 24 Hour After Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).|
1724234|NCT00642174|3174490|Superiority or Other||Mean Difference (Net)|-26.6|||<|0.0001||95.0|-31.18|-22.02||P-value for 4 Hour After Loading Dose (5 uM ADP). A priori threshold for statisitical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).|
1724235|NCT00642174|3174490|Superiority or Other||Mean Difference (Net)|-23.0|||<|0.0001||95.0|-28.45|-17.55||P-value for 1 After Post Loading Dose (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).|
1724236|NCT00642174|3174490|Superiority or Other||Mean Difference (Net)|-0.8|||<|0.5466||95.0|-3.66|1.97||P-value for Baseline (5 uM ADP). A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|The null hypothesis was that there was no difference between prasugrel and clopidogrel in MPA assessed by Light Transmittance Aggregometry (LTA).|
1724237|NCT00642174|3174491|Superiority or Other||Mean Difference (Net)|17.7|||<|0.0001||95.0|10.27|25.04||P-value for 24 Hours After Last Maintenance Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 24 hours post-Last Maintenance Dose (LMD).|
1724238|NCT00642174|3174491|Superiority or Other||Mean Difference (Net)|57.9|||<|0.0001||95.0|49.56|66.19||P-value for 24 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 24 hours after administration of the loading dose.|
1724239|NCT00642174|3174491|Superiority or Other||Mean Difference (Net)|36.5|||<|0.0001||95.0|27.43|45.52||P-value for 1 Hour After Loading Dose. A priori threshold for statistical significance was set at p=0.05 level.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (ie. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there was no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 1 hour after administration of the loading dose.|
1724240|NCT00642174|3174492|Superiority or Other||Least Squares Mean Difference (Net)|61.6|||<|0.0001||95.0|53.83|69.31||P-value is for 4 Hours After Loading Dose.|Mixed Models Analysis|Linear mixed model with treatment, sequence and treatment by sequence (i.e. period) as fixed effects and subject as random effect.|Least Squares Mean Difference = Prasugrel minus Clopidogrel.|Null hypothesis: there is no difference between prasugrel and clopidogrel in IPA assessed by Accumetrics VerifyNow™ P2Y12 4 hours after administration of loading dose. Assuming 90% power, 2-sided alpha of 0.05, and a 17.5% difference in IPA between treatment groups with a standard deviation of 20, a total of 15 completed subjects per sequence group (i.e., 15 subject who receive prasugrel first, then clopidogrel; and 15 subjects who receive clopidogrel first, then prasugrel) was determined.|
1724241|NCT00641147|3174552|Superiority|||||||0.95|||||||Chi-squared||||
1724242|NCT00641147|3174556|Superiority|||||||0.09|||||||t-test, 2 sided||||
1724243|NCT00641147|3174557|Superiority|||||||0.14|||||||t-test, 2 sided||||
1724244|NCT00641147|3174558|Superiority|||||||0.41|||||||t-test, 2 sided||||
1724245|NCT00641147|3174559|Superiority|||||||0.93|||||||t-test, 2 sided||||
1724246|NCT00641147|3174560|Superiority|||||||0.63|||||||t-test, 2 sided||||
1724247|NCT00641147|3174561|Superiority|||||||0.24|||||||t-test, 2 sided||||
1724248|NCT00641147|3174562|Superiority|||||||0.63|||||||t-test, 2 sided||||
1724249|NCT00641147|3174563|Superiority|||||||0.31|||||||Wilcoxon (Mann-Whitney)||||
1724250|NCT00641147|3174564|Superiority|||||||0.16|||||||Chi-squared||||
1724251|NCT00641147|3174565|Superiority|||||||0.85|||||||Chi-squared||||
1724252|NCT00641147|3174566|Superiority|||||||0.76|||||||t-test, 2 sided||||
1724253|NCT00641147|3174567|Superiority|||||||0.57|||||||ANCOVA||||
1724254|NCT00641147|3174567|Superiority|||||||0.58|||||||t-test, 2 sided||||
1724283|NCT00640510|3174651|Superiority or Other|||||||1||||||P-value for Change from Baseline to 15 minutes. Change = Timepoint minus Baseline.|t-test, 2 sided||||
1724452|NCT00635882|3175325|Superiority or Other|||||||0.002|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."|
1724255|NCT00641056|3174571|Superiority or Other||Geometric Least Squares Mean Ratio|1.07|Standard Error of the Mean|0.04||0.077|2-Sided|95.0|0.99|1.15||No adjustments for multiplicity were performed|Mixed Models Analysis|||Triglycerides data were logarithm-transformed and the change at Week 26 to baseline, expressed as the ratio, was analyzed by MMRM ANCOVA with change in triglycerides as the dependent variable; treatment, baseline triglycerides, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.|
1724256|NCT00641056|3174572|Superiority or Other||Least Squares Mean Difference|-0.02|Standard Error of the Mean|0.02||0.377|2-Sided|95.0|-0.05|0.02||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in HDL as the dependent variable; treatment, baseline HDL, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.|
1724257|NCT00641056|3174573|Superiority or Other||Least Squares Mean Difference|-0.07|Standard Error of the Mean|0.07||0.292|2-Sided|95.0|-0.21|0.06||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in total cholesterol as the dependent variable; treatment, baseline total cholesterol, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.|
1724258|NCT00641056|3174574|Superiority or Other||Least Squares Mean Difference|-4.05|Standard Error of the Mean|0.27|<|0.001|2-Sided|95.0|-4.57|-3.52||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in BW as the dependent variable; treatment, baseline BW, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.|
1724259|NCT00641056|3174575|Superiority or Other||Least Squares Mean Difference|0.63|Standard Error of the Mean|0.19||0.001|2-Sided|95.0|0.25|1.0||No adjustments for multiplicity were performed|Mixed Models Analysis|||MMRM ANCOVA with change in FSG as the dependent variable; treatment, baseline FSG, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects.|
1724260|NCT00641056|3174576|Superiority or Other|||||||0.002||||||No adjustments for multiplicity were performed|Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c <=6.5% at Week 26 were compared between treatments using a CMH test, in which background OAD and country served as the stratification factors.|
1724261|NCT00641056|3174577|Superiority or Other|||||||0.097||||||No adjustments for multiplicity were performed|Cochran-Mantel-Haenszel|||Percentage of patients achieving HbA1c <=7.0% at Week 26 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which background OAD and country served as the stratification factors.|
1724262|NCT00641056|3174578|Non-Inferiority or Equivalence|Power: 205 patients per treatment group would provide approximately 92% power to detect a true difference between treatments of 0.4% in change in HbA1c from baseline with a 2-sided t test at a significance level of 0.05, assuming a common standard deviation of 1.2%.|Least Squares Mean Difference|-0.16|Standard Error of the Mean|0.07||0.017|2-Sided|95.0|-0.29|-0.03||No adjustments for multiplicity were performed|Mixed Models Analysis|||Mixed-model Repeated Measures (MMRM) Analysis of Covariance (ANCOVA) model includes treatment, baseline HbA1c, country, background OAD stratum, week of visit, and treatment-by-week interaction as fixed effects; patient and error as random effects. Superiority of exenatide once weekly to insulin glargine is concluded if the upper limit of the 95% confidence interval for the treatment difference [exenatide once weekly-insulin glargine]<0; noninferiority is concluded if this upper limit<0.3%.|
1724263|NCT00641043|3174579|Superiority or Other||Odds Ratio (OR)|3.823|||<|0.0001||95.0|2.286|6.394|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."|
1724264|NCT00641043|3174581|Superiority or Other||Odds Ratio (OR)|1.348||||0.3547||95.0|0.716|2.537|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."|
1724265|NCT00641043|3174583|Superiority or Other||Odds Ratio (OR)|2.103||||0.0051||95.0|1.25|3.539|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."|
1724266|NCT00641043|3174584|Superiority or Other||Mean Difference (Final Values)|-13.9|Standard Error of the Mean|3.4|<|0.0001||95.0|-20.5|-7.3|||ANCOVA|||Linagliptin vs. Placebo|
1724267|NCT00641043|3174585|Superiority or Other||Mean Difference (Final Values)|-13.2|Standard Error of the Mean|3.2|<|0.0001||95.0|-19.5|-7.0|||ANCOVA|||Linagliptin vs. Placebo|
1724268|NCT00641043|3174586|Superiority or Other||Mean Difference (Final Values)|-16.4|Standard Error of the Mean|3.0|<|0.0001||95.0|-22.3|-10.5|||ANCOVA|||Linagliptin vs. Placebo|
1724269|NCT00641043|3174587|Superiority or Other||Mean Difference (Final Values)|-14.2|Standard Error of the Mean|3.5|<|0.0001||95.0|-21.1|-7.3|||ANCOVA|||Linagliptin vs. Placebo|
1724270|NCT00641043|3174588|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.7|-0.32|||ANCOVA|||Linagliptin vs. Placebo|
1724271|NCT00641043|3174589|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.09|<|0.0001||95.0|-0.67|-0.32|||ANCOVA|||Linagliptin vs. Placebo|
1724272|NCT00641043|3174590|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.07|<|0.0001||95.0|-0.52|-0.24|||ANCOVA|||Linagliptin vs. Placebo|
1724273|NCT00641043|3174591|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.71|-0.3|||ANCOVA|||Linagliptin vs. Placebo|
1724274|NCT00640653|3174609|Superiority or Other||Risk Ratio (RR)|0.67||||0.03|2-Sided|95.0|0.48|0.96||The significance criterion was set at alpha = .05.|generalized linear regression|Log link was specified|Treatment was coded as 1 vs health control coded as 0.|With alpha = .05, 2-tailed, and 37.4% of the control group initiating sexual intercourse by 24-month follow-up, a total sample size of 563 participants completing the trial was projected to provide power of 80% to detect a difference of 16.8% in self-reported sexual intercourse between an HIV intervention condition and the health promotion control condition.|
1724275|NCT00640510|3174649|Superiority or Other|||||||1||||||P-value for 2 Hours.|Fisher Exact||||
1724276|NCT00640510|3174649|Superiority or Other|||||||1||||||P-value for 90 Minutes.|Fisher Exact||||
1724277|NCT00640510|3174649|Superiority or Other|||||||1||||||P-value for 60 Minutes.|Fisher Exact||||
1724278|NCT00640510|3174649|Superiority or Other|||||||1||||||P-value for 30 Minutes.|Fisher Exact||||
1724284|NCT00640510|3174652|Superiority or Other|||||||0.94|||||||t-test, 2 sided|||A sample size of at least 15 patients per group was necessary to verify that the decrease in PANSS-EC total score was significantly greater in the IM olanzapine group than the placebo group using Student's t-test with a power of 90% at a two-sided significance level of 5%.|
1724285|NCT00640146|3174796|Other|||||||0.0463|||||||Fisher Exact|||Analysis was performed using Fisher exact test comparing the percentage of participants with a laxation response within 4 hours of the first dose of study drug, testing MNTX against placebo.|
1724286|NCT00640146|3174797|Other|||||||0.0213|||||||Fisher Exact|||Analysis was performed using Fisher exact test comparing the percentage of participants with a laxation response within 2 hours of the first dose of study drug, testing MNTX against placebo.|
1724287|NCT00639379|3174881|Non-Inferiority or Equivalence|Non-inferiority margin = 0.5|Mean Difference (Final Values)|-0.01267|Standard Error of the Mean|0.01265|||2-Sided|98.98|-0.01267|0.01986|||||The mean difference was calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is senofilcon A toric is non-inferior to alphafilcon A toric by having a lower level of corneal staining.|
1724288|NCT00639379|3174882|Non-Inferiority or Equivalence|Non-inferiority margin = -0.4|Mean Difference (Final Values)|-0.01185|Standard Error of the Mean|0.08566|||2-Sided|98.98|-0.2337|-0.01185|||||The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for subjective vision.|
1724289|NCT00639379|3174883|Non-Inferiority or Equivalence|Non-inferiority margin = -0.4|Mean Difference (Final Values)|0.1868|Standard Error of the Mean|0.0921|||2-Sided|98.98|-0.0517|0.1868|||||The mean difference is calculated as senofilcon A toric minus alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for lens comfort.|
1724290|NCT00639379|3174884|Non-Inferiority or Equivalence|Non-inferiority margin = 0.65|Odds Ratio (OR)|1.416|||||2-Sided|98.98|0.68|1.416|||||Odds ratio is senofilcon A toric / alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens stability within 5 degrees.|
1724291|NCT00639379|3174885|Non-Inferiority or Equivalence|Non-inferiority margin is 0.65|Odds Ratio (OR)|0.967|||||2-Sided|98.98|0.436|0.967|||||Odds ratio is senofilcon A toric / alphafilcon A toric.|Alternative hypothesis is that senofilcon A toric is non-inferior to alphafilcon A toric for proportion of eyes with lens orientation within 5 degrees.|
1724292|NCT00639158|3174888|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Rank-sum test||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.|
1724293|NCT00639158|3174889|Superiority or Other||||||<|0.001|||||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.|
1724294|NCT00639158|3174890|Superiority or Other||||||<|0.001|||||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.|
1724295|NCT00639158|3174891|Superiority or Other||||||<|0.001|||||||ANCOVA|Corresponding lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.|
1724296|NCT00639158|3174892|Superiority or Other||||||<|0.001|||||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.|
1724297|NCT00639158|3174893|Superiority or Other||||||<|0.001||||||The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.|ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||A sample size of 212 per arm provided 90% power and > 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.|
1724298|NCT00639158|3174894|Superiority or Other|||||||0.004|||||||ANCOVA|Corresponding baseline lipid value as the covariate and with effect for treatment group.||Secondary endpoints were tested in fixed sequence. If superiority of ABT-335 + atorvastatin + ezetimibe treatment was demonstrated for primary endpoints, secondary endpoints were tested in ranked order of apoA1, VLDL-C, apoC3, non-HDL-C, apoB, and hsCRP at alpha = 0.05 level until 1 secondary endpoint failed to reach statistical significance.|
1724299|NCT00639158|3174895|Superiority or Other||||||<|0.001||||||The treatment group comparisons for both primary efficacy variables must have demonstrated superiority of ABT-335 + atorvastatin + ezetimibe to declare this arm successful. Thus, no adjustments were made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||A sample size of 212 per arm provided 90% power and > 99% power with a 2-sided alpha = 0.05 level to detect differences between treatment arms of 6% and 17% in the percent change in HDL-C and TG, respectively, assuming an SD of 19% and 30%, respectively. This sample size provided an overall power of approximately 90% for the 2 primary comparisons. If a loss to follow-up rate of 8% was assumed, the sample size needed to be increased to 230 per arm to maintain the above power.|
1726667|NCT00594568|3181044|Superiority or Other|||||||0.61|||||||Mixed Models Analysis||||
1724300|NCT00638846|3174934|Superiority or Other||Median Difference (Final Values)|0.368|Standard Error of the Mean|0.1331|||2-Sided|97.4|0.07001|0.368|||||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric.|
1724301|NCT00638846|3174935|Non-Inferiority or Equivalence|Non-inferiority margin is -0.4.|Mean Difference (Final Values)|-0.0688|Standard Error of the Mean|0.1648|||2-Sided|97.5|-0.0688|-0.0197|||||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having a lower grade fo corneal staining.|
1724302|NCT00638846|3174936|Superiority or Other||Mean Difference (Final Values)|0.368|Standard Error of the Mean|0.1331|||2-Sided|97.4|0.07001|0.368|||||The mean difference is calculated as senofilcon A toric minus balafilcon A toric.|Alternative hypothesis is that senofilcon A is superior to balafilcon A.|
1724303|NCT00638846|3174937|Superiority or Other||Mean Difference (Final Values)|-1.1307|Standard Error of the Mean|0.2856|||2-Sided|97.5|-1.1307|-0.568|||||The mean difference is calculated as senofilcon A toric minus balafilcon At toric.|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less time required to fit.|
1724304|NCT00638846|3174938|Superiority or Other||Odds Ratio (OR)|1.138|||||2-Sided|97.4|0.624|1.138|||||Odds ratio was senofilcon A toric/balafilcon A toric|Alternative hypothesis is that senofilcon A toric is superior to balafilcon A toric by having less degrees of instability.|
1724305|NCT00638846|3174939|Superiority or Other||Odds Ratio (OR)|1.739|||||2-Sided|97.4|1.136|1.739|||||Odds ratio was senofilcon A toric / balafilcon A toric|Alternative hypothesis is senofilcon A toric is superior to balfilcon A toric by having less degrees of rotation|
1724306|NCT00638690|3174947|Superiority or Other||Hazard Ratio (HR)|0.673|||<|0.0001|2-Sided|95.0|0.585|0.776||The nominal P-value = 0.05.|Log Rank|This was a stratified analysis.|||
1724307|NCT00638690|3174948|Superiority or Other||Risk Ratio (RR)|5.266|||<|0.001|2-Sided|95.0|3.459|8.018||Nominal P-value = 0.05.|Chi-squared||||
1724308|NCT00638690|3174949|Superiority or Other||Hazard Ratio (HR)|0.58|||<|0.0001||95.0|0.462|0.728||Nominal P-value = 0.05.|Log Rank|This was a stratified analysis.|||
1724309|NCT00638690|3174950|Superiority or Other||Hazard Ratio (HR)|0.646|||<|0.0001|2-Sided|95.0|0.543|0.768||Nominal P-value is 0.0142 at interim analysis based on group sequential design.|Log Rank|This was a stratified analysis.|||
1724310|NCT00638404|3174987|Other|Correlation of|||||<|0.001|||||||Spearman Correlation||||
1724311|NCT00638404|3174988|Other||||||<|0.001|||||||Spearman Correlation||||
1724312|NCT00638404|3174989|Other||||||<|0.001|||||||Spearman Correlation|||preoperative questionnaire evaluating anticipated amount of pain medication potentially needed postoperatively; 0= none at all up to 100=as much as possible|
1724313|NCT00638404|3174990|Other|correlation of anticipated pain to 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation||||
1724314|NCT00638404|3174990|Other|correlation of anticipated pain medication 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation||||
1724315|NCT00638404|3174990|Other|correlation of anxiety to evoked pain at 24 hour|||||<|0.001|||||||Spearman Correlation||||
1724316|NCT00638404|3174990|Other|correlation of anxiety, anticipated pain medication use and anticipated pain to 24 hour evoked pain measured|||||<|0.001|||||||Spearman Correlation|anxiety to evoked pain is 0.24 (P<.001); anticipated pain to evoked pain is 0.33 (P<.001); anticipated pain medication to evoked pain is 0.33(P<.001).|||
1724317|NCT00638274|3174997|Other||||||>|0.05|||||||Chi-squared||||
1724318|NCT00638274|3174997|Other||||||>|0.05|||||||Chi-squared||||
1724319|NCT00638014|3175058|Superiority or Other|||||||0.41|||||||t-test, 2 sided||||
1724320|NCT00637377|3175101|Superiority or Other||Differences in Least Squares means|-0.733||||0.0727|2-Sided|95.0|-1.534|0.068||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 2mg Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.|
1724321|NCT00637377|3175101|Superiority or Other||Differences in Least Squares means|0.17||||0.6784|2-Sided|95.0|-0.632|0.972||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 0.5mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.|
1724322|NCT00637377|3175101|Superiority or Other||Differences in Least Squares means|-1.18||||0.0038|2-Sided|95.0|-1.979|-0.382||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A negative value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline CNV area as covariate. The null hypothesis is that both mean changes are equal.|
1724323|NCT00637377|3175102|Superiority or Other||Differences in Least Squares means|-1.947||||0.0717|2-Sided|95.0|-4.0659|0.1718||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.|
1724324|NCT00637377|3175102|Superiority or Other||Differences in Least Squares means|-0.932||||0.3917|2-Sided|95.0|-3.0658|1.2019||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 0.5mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.|
1724325|NCT00637377|3175102|Superiority or Other||Differences in Least Squares means|-2.7885||||0.0097|2-Sided|95.0|-4.9012|-0.6757||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline NEI VFQ-25 total score as covariate. The null hypothesis is that both mean changes are equal.|
1724326|NCT00637377|3175103|Superiority or Other||Risk Difference (RD)|-2.65||||0.49|2-Sided|95.0|-10.18|4.88||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q8 group|The null hypothesis is that the two proportions are equal.|
1724327|NCT00637377|3175103|Superiority or Other||Risk Difference (RD)|0.78||||0.843|2-Sided|95.0|-6.91|8.46||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 0.5mg Q4 group|The null hypothesis is that the two proportions are equal.|
1724328|NCT00637377|3175103|Superiority or Other||Risk Difference (RD)|-4.57||||0.229|2-Sided|95.0|-12.02|2.88||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|Chi-squared||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q4 group|The null hypothesis is that the two proportions are equal.|
1724329|NCT00637377|3175104|Superiority or Other||Differences in Least Squares means|-0.9014||||0.4131|2-Sided|95.0|-3.0615|1.2587||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors the Aflibercept 2mg Q8 group|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.|
1724330|NCT00637377|3175104|Superiority or Other||Differences in Least Squares means|-0.062||||0.9555|2-Sided|95.0|-2.2398|2.1158||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 0.5mg Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.|
1724331|NCT00637377|3175104|Superiority or Other||Differences in Least Squares means|-1.9484||||0.076|2-Sided|95.0|-4.1009|0.204||as adjustment of multiple comparisons a conditional sequence of statistical hypotheses (a-priori ordered hypotheses) is used with alpha = 0.05.|ANCOVA||The difference is calculated as Aflibercept minus Ranibizumab. A positive value favors Aflibercept 2mg Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline ETDRS letter score as covariate. The null hypothesis is that both mean changes are equal.|
1724332|NCT00637377|3175105|Non-Inferiority or Equivalence|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.13|||||2-Sided|95.0|-4.81|2.55|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 2mg Q8 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 2mg Q8, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 2mg Q8).|
1724333|NCT00637377|3175105|Non-Inferiority or Equivalence|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.84|||||2-Sided|95.0|-5.4|1.71|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 0.5mg Q4 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 0.5mg Q4, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 0.5mg Q4).|
1724334|NCT00637377|3175105|Non-Inferiority or Equivalence|The non-inferiority margin is set to 10. The power is 90 % according to the sample size estimation of the study protocol.|Risk Difference (RD)|-1.2|||||2-Sided|95.0|-4.86|2.46|||||The difference is calculated as Ranibizumab minus Aflibercept. A negative value favors the Aflibercept 2mg Q4 group. As adjustment of multiple comparisons a conditional sequence of statistical hypotheses is used with alpha = 0.05.|null hypothesis: pi ≤ pc-delta where pi is the probability that a participant maintained vision at week 52 under Aflibercept 2mg Q4, pc is the probability that a participant maintained vision at week 52 under Ranibizumab 0.5mg Q4 and delta is the non-inferiority margin. The null hypothesis is tested calculating a two-sided 95 % confidence using normal approximation of the difference of percentages of participants maintaining vision at week 52 (Ranibizumab 0.5mg Q4 minus Aflibercept 2mg Q4).|
1724335|NCT00637299|3175107|Superiority or Other||||||<|0.05|||||||t-test, 1 sided||||
1724336|NCT00637299|3175108|Superiority or Other||||||<|0.01|||||||t-test, 1 sided||||
1724349|NCT00637273|3175116|Superiority or Other||Least Squares Mean Difference|5.1|Standard Error of the Mean|0.415|<|0.0001|2-Sided|95.0|4.28|5.91||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 26 was analyzed by an analysis of covariance (ANCOVA) model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of body weight as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724337|NCT00637273|3175110|Superiority or Other||Geometric Least Squares Mean Ratio|0.89|Standard Error of the Mean|0.035||0.0062|2-Sided|95.0|0.82|0.96||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 26 to baseline (Day 1), expressed as the ratio, was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of fasting triglycerides as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724338|NCT00637273|3175110|Superiority or Other||Geometric Least Squares Mean Ratio|1.0|Standard Error of the Mean|0.04||0.9718|2-Sided|95.0|0.93|1.08||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 26 to baseline (Day 1), expressed as the ratio, was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of fasting triglycerides as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724339|NCT00637273|3175111|Superiority or Other||Least Squares Mean Difference|4.2|Standard Error of the Mean|0.79|<|0.0001|2-Sided|95.0|2.6|5.7||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting HDL from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of fasting HDL as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724340|NCT00637273|3175111|Superiority or Other||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.8|<|0.9546|2-Sided|95.0|-1.6|1.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting HDL from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of fasting HDL as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724341|NCT00637273|3175112|Superiority or Other||Least Squares Mean Difference|6.8|Standard Error of the Mean|3.3||0.0814|2-Sided|95.0|0.3|13.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting total cholesterol from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of fasting total cholesterol as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724342|NCT00637273|3175112|Superiority or Other||Least Squares Mean Difference|3.7|Standard Error of the Mean|3.31||0.2686|2-Sided|95.0|-2.8|10.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting total cholesterol from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of fasting total cholesterol as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724343|NCT00637273|3175113|Superiority or Other||Least Squares Mean Difference|-1.1|Standard Error of the Mean|0.75||0.1685|2-Sided|95.0|-2.6|0.4||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of diastolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724344|NCT00637273|3175113|Superiority or Other||Least Squares Mean Difference|1.0|Standard Error of the Mean|0.75||0.1685|2-Sided|95.0|-0.4|2.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in diastolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of diastolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724345|NCT00637273|3175114|Superiority or Other||Least Squares Mean Difference|2.0|Standard Error of the Mean|1.25||0.1117|2-Sided|95.0|-0.5|4.5||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of systolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724346|NCT00637273|3175114|Superiority or Other||Least Squares Mean Difference|3.8|Standard Error of the Mean|1.26||0.0055|2-Sided|95.0|1.3|6.3||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in systolic blood pressure from baseline (Day 1) to Week 26 was analyzed by an ANCOVA model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of systolic blood pressure as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724347|NCT00637273|3175115|Superiority or Other||Least Squares Mean Difference|4.4|Standard Error of the Mean|4.98||0.3729|2-Sided|95.0|-5.3|14.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 26 was analyzed using an ANCOVA model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of fasting plasma glucose as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724348|NCT00637273|3175115|Superiority or Other||Least Squares Mean Difference|15.5|Standard Error of the Mean|4.95||0.0038|2-Sided|95.0|5.7|25.2||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day 1) to Week 26 was analyzed using an ANCOVA model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of fasting plasma glucose as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724453|NCT00635882|3175325|Superiority or Other||||||<|0.001|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."|
1724350|NCT00637273|3175116|Superiority or Other||Least Squares Mean Difference|1.54|Standard Error of the Mean|0.416|<|0.0002|2-Sided|95.0|0.72|2.35||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANCOVA|||Analysis: Change in body weight from baseline (Day 1) to Week 26 was analyzed by an analysis of covariance (ANCOVA) model including treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors, and baseline value of body weight as a covariate. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724351|NCT00637273|3175117|Superiority or Other|||||||0.0091||||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of <=6.0% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (<9% or >=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724352|NCT00637273|3175117|Superiority or Other|||||||0.17||||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of <=6.0% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (<9% or >=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724353|NCT00637273|3175118|Superiority or Other|||||||0.012||||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of <=6.5% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (<9% or >=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724354|NCT00637273|3175118|Superiority or Other||||||<|0.0001||||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target of <=6.5% at Week 26 were compared between treatments using a CMH test, in which baseline HbA1c stratum (<9% or >=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724355|NCT00637273|3175119|Superiority or Other|||||||0.0015||||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target of <7% at Week 26 were compared between treatments using a Cochran Mantel Haenszel (CMH) test, in which baseline HbA1c stratum (<9% or >=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724356|NCT00637273|3175119|Superiority or Other||||||<|0.0001||||||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target of <7% at Week 26 were compared between treatments using a Cochran Mantel Haenszel (CMH) test, in which baseline HbA1c stratum (<9% or >=9%) and country served as stratification factors. Null hypothesis: no difference across treatments. Power: based on the primary measurement.|
1724357|NCT00637273|3175120|Superiority or Other||Least Squares Mean Difference|0.32|Standard Error of the Mean|0.131||0.0165|2-Sided|95.0|0.06|0.57||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANOVA|Analysis of Variance (ANOVA) model includes treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors.||Null hypothesis: no difference across treatments. Alternative hypothesis: a difference exists between exenatide once weekly and at least one comparator group (sitagliptin or pioglitazone). Power: Assuming 10% dropout, delta=0.5%, and common SD=1.2%, 450 subjects would provide >90% power to detect a treatment difference (alpha=0.05, two-sided) in the change in HbA1c between exenatide once weekly and sitagliptin or pioglitazone, with Hochberg's multiplicity adjustment method.|
1724358|NCT00637273|3175120|Superiority or Other||Least Squares Mean Difference|0.63|Standard Error of the Mean|0.131|<|0.0001|2-Sided|95.0|0.37|0.89||Adjusted p-value was derived using Hochberg's procedure for multiple treatment comparisons.|ANOVA|Analysis of Variance (ANOVA) model includes treatment, country, and baseline HbA1c stratum (<9.0% or >=9.0%) as factors.||Null hypothesis: no difference across treatments. Alternative hypothesis: a difference exists between exenatide once weekly and at least one comparator group (sitagliptin or pioglitazone). Power: Assuming 10% dropout, delta=0.5%, and common SD=1.2%, 450 subjects would provide >90% power to detect a treatment difference (alpha=0.05, two-sided) in the change in HbA1c between exenatide once weekly and sitagliptin or pioglitazone, with Hochberg's multiplicity adjustment method.|
1724359|NCT00637247|3175124|Superiority or Other|||||||0.2|||||||Log Rank|||The hypothesis that survival curves were equal in the two treatment groups was tested with a one-sided logrank test at the alpha-0.2 level, one sided. The power of this test is 80% for detecting the hypothesized increase in median survival of 2.4 months for subjects in the experimental arm.|
1724360|NCT00637156|3175146|Superiority or Other||Posterior Mean Difference|-0.1||||0.892|2-Sided|95.0|-0.258|0.058||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the hospital stay in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1– μ0 < 0|data) be at least 97.5%, the superiority would be claimed."|
1724361|NCT00637156|3175147|Superiority or Other||Posterior Mean Difference|11.5||||0.02|2-Sided|95.0|0.56|22.44|||Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the blood loss in two treatment groups was assessed.The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1– μ0 < 0|data) be at least 97.5%, the superiority would be claimed."|
1724374|NCT00637156|3175155|Superiority or Other|||||||0.931||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of neurological success rates in two treatment groups was performed if non-inferiority was demonstrated.|
1724484|NCT00635492|3175398|Superiority or Other||Odds Ratio (OR)|0.94||||0.0141|2-Sided|95.0|0.9|0.99|||Regression, Logistic|||Random blood glucose - 1 mmol/L higher|
1724362|NCT00637156|3175148|Superiority or Other||Posterior Mean Difference|0.4||||0|2-Sided|95.0|0.252|0.548||The posterior probably of superiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean difference (µ1- µ0) and the corresponding 95% highest posterior density (HPD) interval were presented instead of the usual 95% CI.|"Superiority comparison of the operative time in two treatment groups was assessed. The null hypothesis is H0: μ1 = μ0 and the alternative hypothesis is Ha: μ1 ≠ μ0, where μ0 and μ1 denote the mean in control group the investigational group, respectively. Should the posterior probability of superiority P(μ1– μ0 < 0|data) be at least 97.5%, the superiority would be claimed."|
1724363|NCT00637156|3175149|Superiority or Other|||||||0.859||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of gait success rates in two treatment groups was performed if non-inferiority was demonstrated.|
1724364|NCT00637156|3175149|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.013||||1|2-Sided|95.0|-0.013|0.04||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the gait success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1724365|NCT00637156|3175150|Superiority or Other|||||||0.271||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of FSU success rates in two treatment groups was performed if non-inferiority was demonstrated.|
1724366|NCT00637156|3175150|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.017||||0.997|2-Sided|95.0|-0.072|0.04||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the FSU success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1724367|NCT00637156|3175151|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.024||||0.945|2-Sided|95.0|-0.12|0.067||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the SF-36 MCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1724368|NCT00637156|3175152|Superiority or Other|||||||0.767||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of SF-36 PCS success rates in two treatment groups was performed if non-inferiority was demonstrated.|
1724369|NCT00637156|3175152|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.024||||1|2-Sided|95.0|-0.042|0.088||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the SF-36 PCS success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1724370|NCT00637156|3175153|Superiority or Other|||||||0.395||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of arm pain success rates in two treatment groups was performed if non-inferiority was demonstrated.|
1724371|NCT00637156|3175153|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|-0.008||||0.997|2-Sided|95.0|-0.073|0.056||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the arm pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1724372|NCT00637156|3175154|Superiority or Other|||||||0.852||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of neck pain success rates in two treatment groups was performed if non-inferiority was demonstrated.|
1724373|NCT00637156|3175154|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.021||||1|2-Sided|95.0|-0.019|0.062||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the neck pain success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1724375|NCT00637156|3175155|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.05||||1|2-Sided|95.0|-0.014|0.119||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the neurological success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1724376|NCT00637156|3175156|Superiority or Other|||||||0.99||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of NDI success rates in two treatment groups was performed if non-inferiority was demonstrated.|
1724377|NCT00637156|3175156|Non-Inferiority or Equivalence|Non-inferiority margin is 0.1.|Risk Difference (RD)|0.088||||1|2-Sided|95.0|0.012|0.167||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the NDI success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P (p1 - p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1724378|NCT00637156|3175157|Superiority or Other|||||||0.993||||||The posterior probability of superiority was calculated and presented instead of the p-value.|Bayesian model|||Superiority comparison of overall success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated. If the posterior probability is at least 0.95, a claim of superiority can be made.|
1724379|NCT00637156|3175157|Non-Inferiority or Equivalence|The non-inferiority margin is 0.1.|Risk Difference (RD)|0.113||||1|2-Sided|95.0|0.022|0.201||The posterior probability of non-inferiority was calculated and presented instead of the p-value.|Bayesian model||The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.|"The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 – p0 > -d | data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed."|
1724380|NCT00637000|3175159|Superiority or Other|||||||0.238||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724381|NCT00637000|3175160|Superiority or Other||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724382|NCT00637000|3175161|Superiority or Other|||||||0.117||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724383|NCT00637000|3175162|Superiority or Other||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724384|NCT00637000|3175163|Superiority or Other||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724385|NCT00637000|3175164|Superiority or Other|||||||0.028||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724386|NCT00637000|3175165|Superiority or Other|||||||0.349||||||The p-value is not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724387|NCT00637000|3175166|Superiority or Other||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724388|NCT00637000|3175167|Superiority or Other|||||||0.762||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724389|NCT00637000|3175168|Superiority or Other||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724390|NCT00637000|3175169|Superiority or Other||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724391|NCT00637000|3175170|Superiority or Other|||||||0.006||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724392|NCT00637000|3175171|Superiority or Other||||||<|0.0001|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724393|NCT00637000|3175172|Superiority or Other||||||<|0.0001|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724394|NCT00637000|3175173|Superiority or Other|||||||0.035||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724395|NCT00637000|3175174|Superiority or Other|||||||0|||||||Repeated measures model|Group by time repeated measures model with a first-order autoregressive covariance structure.|||
1724486|NCT00635492|3175400|Superiority or Other||Odds Ratio (OR)|0.96|||<|0.0001|2-Sided|95.0|0.95|0.97|||Regression, Logistic|||Age - 1 year older|
1724396|NCT00637000|3175175|Superiority or Other||||||<|0.0001||||||The p-value was not adjusted for multiple comparisons.|Repeated measures model|The statistical method used was a group by time repeated measures model with a first-order autoregressive covariance structure||To test the primary study hypothesis that neither soluble film formulation would precipitate an opioid withdrawal syndrome, peak COWS score in the 23.5 hour period after the initial soluble film administration were compared to pre-administration baseline COWS scores (30 minutes prior to soluble film administration) using a group by time repeated measures model with a first-order autoregressive covariance structure.|
1724397|NCT00636818|3175188|Superiority or Other||||||<|0.001||||||P-value for Mental Health: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724398|NCT00636818|3175188|Superiority or Other||||||<|0.01||||||P-value for Role-Emotional: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724399|NCT00636818|3175188|Superiority or Other||||||<|0.086||||||P-value for Social Functioning: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724400|NCT00636818|3175188|Superiority or Other||||||<|0.043||||||P-value for Vitality: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724401|NCT00636818|3175188|Superiority or Other||||||<|0.087||||||P-value for General Health Perception: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724402|NCT00636818|3175188|Superiority or Other||||||<|0.365||||||P-value for Bodily Pain: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724403|NCT00636818|3175188|Superiority or Other||||||<|0.446||||||P-value for Role-Physical: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724404|NCT00636818|3175188|Superiority or Other||||||<|0.037||||||P-value for Physical Functioning: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724405|NCT00636818|3175188|Superiority or Other||||||<|0.001||||||P-value for Mental Component Summary: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724406|NCT00636818|3175188|Superiority or Other||||||<|0.791||||||P-value for Physical Component Summary: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724407|NCT00636818|3175189|Superiority or Other|||||||0.144||||||P-value for Color-Word Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724408|NCT00636818|3175189|Superiority or Other|||||||0.005||||||P-value for Color Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724409|NCT00636818|3175189|Superiority or Other|||||||0.005||||||P-value for Word Test: Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724410|NCT00636818|3175190|Superiority or Other|||||||0.005||||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724411|NCT00636818|3175191|Superiority or Other|||||||0.013||||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724412|NCT00636818|3175192|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724413|NCT00636818|3175193|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724414|NCT00636818|3175194|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline. Change=Endpoint minus Baseline.|t-test, 2 sided||||
1724415|NCT00636649|3175216|Superiority or Other|||||||0.724|||||||ANCOVA|||TFEQ-HUN|
1724416|NCT00636649|3175216|Superiority or Other|||||||0.498|||||||ANCOVA|||TFEQ-DIS|
1724417|NCT00636649|3175216|Superiority or Other|||||||0.225|||||||ANCOVA|||TFEQ-RES|
1724418|NCT00636649|3175217|Superiority or Other|||||||0.579|||||||ANCOVA||||
1724419|NCT00636649|3175218|Superiority or Other|||||||0.396|||||||ANCOVA|||CISS-SOC|
1724420|NCT00636649|3175218|Superiority or Other|||||||0.759|||||||ANCOVA|||CISS-AVD|
1724421|NCT00636649|3175218|Superiority or Other|||||||0.196|||||||ANCOVA|||CISS-DIS|
1724422|NCT00636649|3175218|Superiority or Other|||||||0.185|||||||ANCOVA|||CISS-EMOT|
1724423|NCT00636649|3175218|Superiority or Other|||||||0.993|||||||ANCOVA|||CISS-TASK|
1724424|NCT00636636|3175221|Superiority or Other||Least square mean difference|-0.55|Standard Error of the Mean|0.2||0.007|2-Sided|95.0|-0.96|-0.15|||ANCOVA||||
1724425|NCT00636636|3175222|Superiority or Other||Least square mean difference|-0.71|Standard Error of the Mean|0.18||0.0001|2-Sided|95.0|-1.07|-0.35|||ANCOVA||P-value versus Placebo for pairwise test of difference of LS mean change from baseline between G-ER and Placebo groups is based on t-test of Type III analysis.||
1724426|NCT00636636|3175223|Superiority or Other||Difference in proportion|0.102||||0.0268|2-Sided|95.0|0.01|0.19|||Z test|||P-value (vs Placebo) for pairwise test of treatment effect between G-ER group and Placebo group is based on Z test for difference between the 2 groups in proportion of participants who were categorized as very much or much improved in CGIC at endpoint. Proportion in each group calculated from number of participants categorized as very much or much improved relative to total number of participants in ITT population.|
1724427|NCT00636636|3175224|Superiority or Other||Difference in proportion|0.092||||0.0434|2-Sided|95.0|0.0|0.18|||Z test|||P-value (vs Placebo) for pairwise test of treatment effect between G-ER group and Placebo group is based on Z test for difference between the 2 groups in proportion of participants who were categorized as very much or much improved in PGIC at endpoint. Proportion in each group calculated from number of participants categorized as very much or much improved relative to total number of participants in ITT population.|
1724428|NCT00636636|3175225|Superiority or Other||Least squares mean difference|-0.49|Standard Error of the Mean|0.2||0.0125|2-Sided|95.0|-0.88|-0.11|||ANCOVA||||
1724429|NCT00636181|3175294|Superiority|||||||0.3||||||PSG outcomes employed analysis of variance for approximately normally distributed outcomes (or outcomes that could be transformed to an approximately normal distribution), and the Kruskal-Wallis test for non-normal outcomes.|Kruskal-Wallis|Pairwise differences were determined using Tukey-Kramer test- ANOVA applied or by Mann-Whitney-Wilcoxon summed rank tests and Bonferroni adjustment.|||
1724451|NCT00635882|3175325|Superiority or Other|||||||0.002|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."|
1726668|NCT00594568|3181044|Superiority or Other|||||||0.045|||||||Mixed Models Analysis||||
1724430|NCT00636168|3175300|Superiority||Hazard Ratio (HR)|0.72||||0.0013|2-Sided|95.1|0.58|0.88|||Log Rank|stratified 2-sided log-rank test||Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with >= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.1% confidence interval are based on a stratified Cox proportional hazards model|
1724431|NCT00636168|3175303|Superiority||Hazard Ratio (HR)|0.76||||0.0024|2-Sided|95.8|0.64|0.92|||Log Rank|stratified 2-sided log-rank test||Medians and associated 2-sided 95% confidence intervals are calculated using the method of Brookmeyer and Crowley. Analysis was stratified for stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with >= 4 positive lymph-nodes) as recorded at randomization. P-value was based on stratified 2-sided log-rank test. Hazard of 10 mg/kg Ipilimumab over hazard of Placebo, with 2-sided 95.8% confidence interval are based on a stratified Cox proportional hazards model|
1724432|NCT00636168|3175306|Superiority||Hazard Ratio (HR)|0.75||||0.0013|2-Sided|95.0|0.64|0.9|||Log Rank|stratified 2-sided log-rank test||The hazard ratio, and its 95 % confidence interval was estimated using a Cox proportional hazards model, stratified by stage (IIIa vs. IIIb vs. IIIc with 1-3 positive lymph-nodes vs. IIIc with >= 4 positive lymph-nodes) as indicated at randomization, with treatment as the single covariate.. The analysis was performed after 528 RFS events per IRC were reported. Two-sided, 95% confidence intervals for median RFS were computed by the Brookmeyer and Crowley method using log-log transformation.|
1724433|NCT00635882|3175319|Superiority or Other|||||||0.005|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."|
1724434|NCT00635882|3175319|Superiority or Other|||||||0.057|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."|
1724435|NCT00635882|3175319|Superiority or Other||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."|
1724436|NCT00635882|3175320|Superiority or Other||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."|
1724437|NCT00635882|3175320|Superiority or Other||||||<|0.002|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."|
1724438|NCT00635882|3175320|Superiority or Other||||||<|0.001|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."|
1724439|NCT00635882|3175321|Superiority or Other|||||||0.963|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."|
1724440|NCT00635882|3175321|Superiority or Other|||||||0.643|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."|
1724441|NCT00635882|3175321|Superiority or Other|||||||0.037|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 1-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."|
1724442|NCT00635882|3175322|Superiority or Other|||||||0.334|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."|
1724443|NCT00635882|3175322|Superiority or Other|||||||0.261|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way ANOVA model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."|
1724444|NCT00635882|3175322|Superiority or Other|||||||0.018|||||||ANOVA|Analysis applies to Mean Change from Baseline to Days 2-15.||"One-way analysis of variance (ANOVA) model with treatment effect was used.~Standard deviation is a Pooled Standard deviation from the one-way ANOVA model with treatment effect."|
1724445|NCT00635882|3175323|Superiority or Other|||||||0.048|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."|
1724446|NCT00635882|3175323|Superiority or Other|||||||0.103|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."|
1724447|NCT00635882|3175323|Superiority or Other|||||||0.12|||||||ANCOVA|Analysis applies to Mean Change from Baseline to Day 15.||"ANCOVA model with treatment and baseline PD15 as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline PD15 as a covariate."|
1724448|NCT00635882|3175324|Superiority or Other|||||||0.336|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."|
1724449|NCT00635882|3175324|Superiority or Other|||||||0.051|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."|
1724450|NCT00635882|3175324|Superiority or Other|||||||0.024|||||||ANCOVA|||"ANCOVA model with treatment and baseline eosinophils as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline EOS as a covariate."|
1724494|NCT00635349|3175424|Superiority or Other|||||||0.1131||||||Day 85; p-value was calculated by Chi-squared test|Chi-squared||||
1724454|NCT00635882|3175326|Superiority or Other|||||||0.018|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."|
1724455|NCT00635882|3175326|Superiority or Other|||||||0.003|||||||ANCOVA|||"ANCOVA model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."|
1724456|NCT00635882|3175326|Superiority or Other||||||<|0.001|||||||ANCOVA|||"Analysis of covariance (ANCOVA) model with treatment and baseline eNO as a covariate was used.~Standard deviation is a Pooled Standard deviation from ANCOVA Model with treatment effect and baseline eNO as a covariate."|
1724457|NCT00635817|3175330|Superiority or Other|||||||0.15||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).|
1724458|NCT00635817|3175330|Superiority or Other|||||||0.347||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).|
1724459|NCT00635817|3175330|Superiority or Other|||||||0.002||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).|
1724460|NCT00635817|3175330|Superiority or Other|||||||0.008||||||There were no adjustments for multiple comparisons.|Wilcoxon (Mann-Whitney)|||Summary statistics were calculated and tests of significance of the ratio versus 1 were performed. All analyses and summaries were conducted separately for the 2 treatment groups (subjects who received leuprolide acetate depot 11.25 mg and 30 mg).|
1724461|NCT00635817|3175331|Superiority or Other|||||||0.102||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.|
1724462|NCT00635817|3175331|Superiority or Other|||||||0.026||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.|
1724463|NCT00635817|3175331|Superiority or Other|||||||0.074||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.|
1724464|NCT00635817|3175331|Superiority or Other|||||||0.099||||||There were no adjustments for multiple comparisons.|t-test, 2 sided|||Summary statistics were calculated and tests of significance of the change versus no change were performed.|
1724465|NCT00635609|3175376|Superiority or Other|||||||0.033|||||||Cochran-Mantel-Haenszel|Stratified on investigational site||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.|
1724466|NCT00635609|3175377|Superiority or Other|||||||0.29|||||||Cochran-Mantel-Haenszel|Stratified on investigational site.||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.|
1724467|NCT00635609|3175378|Superiority or Other|||||||0.765|||||||Cochran-Mantel-Haenszel|Stratified on investigational site.||Study not adequately powered to detect differences in efficacy outcomes. Results to provide estimates of safety and efficacy outcomes.|
1724468|NCT00635570|3175379|Superiority or Other||||||>|0.05|||||||Chi-squared, Corrected||||
1724469|NCT00635570|3175380|Superiority or Other||||||>|0.05|||||||Chi-squared, Corrected||||
1724470|NCT00635570|3175381|Superiority or Other||||||>|0.05|||||||Chi-squared, Corrected||||
1724471|NCT00635570|3175382|Superiority or Other|||||||0.05|||||||Chi-squared, Corrected|Yates's chi-squared test with 1 degree of freedom was used for analysis||The trial sample size of 300 participants total (150 participants each group) was based on two-sided 5% significance testing with 80% power to detect a difference of 10% in adherence between students in the contraceptive vaginal ring group and oral contraceptive pill group.|
1724472|NCT00635492|3175386|Superiority or Other||Hazard Ratio (HR)|0.601||||0.002|2-Sided|95.0|0.432|0.834|||Regression, Cox|||EQ-5D index value at baseline|
1724473|NCT00635492|3175386|Superiority or Other||Hazard Ratio (HR)|1.463||||0.028|2-Sided|95.0|1.043|2.053|||Regression, Cox|||GI symptoms: yes vs. no at baseline|
1724474|NCT00635492|3175387|Superiority or Other||Hazard Ratio (HR)|2.164|||<|0.001|2-Sided|95.0|1.681|2.785|||Regression, Cox|||Insulin regimen: short-acting only vs. long-acting only|
1724475|NCT00635492|3175387|Superiority or Other||Hazard Ratio (HR)|0.549|||<|0.303|2-Sided|95.0|0.175|1.718|||Regression, Cox|||Insulin regimen: other vs. long-acting only|
1724476|NCT00635492|3175387|Superiority or Other||Hazard Ratio (HR)|0.676|||<|0.003|2-Sided|95.0|0.523|0.874|||Regression, Cox|||Insulin regimen: mixtures vs. long-acting only|
1724477|NCT00635492|3175387|Superiority or Other||Hazard Ratio (HR)|0.437|||<|0.001|2-Sided|95.0|0.303|0.63|||Regression, Cox|||Insulin regimen: basal/bolus vs. long-acting only|
1724478|NCT00635492|3175387|Superiority or Other||Hazard Ratio (HR)|2.532|||<|0.001|2-Sided|95.0|1.698|3.777|||Regression, Cox|||Gastrointestinal symptoms: yes vs. no at baseline|
1724479|NCT00635492|3175387|Superiority or Other||Hazard Ratio (HR)|0.96|||<|0.001|2-Sided|95.0|0.937|0.985|||Regression, Cox|||DHP barriers to activity subscale at baseline|
1724480|NCT00635492|3175387|Superiority or Other||Hazard Ratio (HR)|1.118|||<|0.0001|2-Sided|95.0|1.062|1.177|||Regression, Cox|||HbA1c (%) at baseline|
1724481|NCT00635492|3175395|Superiority or Other||Odds Ratio (OR)|0.83||||0.0138|2-Sided|95.0|0.72|0.96|||Regression, Logistic|||LDL cholesterol - 1 mmol/L higher at baseline|
1724482|NCT00635492|3175396|Superiority or Other||Odds Ratio (OR)|1.67||||0.0193|2-Sided|95.0|1.13|2.46|||Regression, Logistic|||Receipt of diet/exercise advice - Yes vs. No|
1724483|NCT00635492|3175397|Superiority or Other||Odds Ratio (OR)|0.98||||0.0107|2-Sided|95.0|0.96|0.99|||Regression, Logistic|||Blood glucose self-monitoring - 1 test/week more|
1726669|NCT00594568|3181044|Superiority or Other|||||||0.134|||||||Mixed Models Analysis||||
1724497|NCT00635349|3175425|Superiority or Other||Mean Difference (Final Values)|-0.68||||0.0628|1-Sided|97.5|-1.41||||t-test, 1 sided||||
1724498|NCT00635349|3175426|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower confidence limit interval was less than -1.0 (1-sided , 97.5% confidence interval)|Mean Difference (Final Values)|1.81||||0.4258|1-Sided|97.5|-6.31||||t-test, 1 sided||||
1724499|NCT00635219|3175430|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.87||0.972|2-Sided|95.0|-1.69|1.75||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724500|NCT00635219|3175430|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.87||0.8918|2-Sided|95.0|-1.82|1.59||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724501|NCT00635219|3175430|Superiority or Other||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.87||0.8121|2-Sided|95.0|-1.91|1.5||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724502|NCT00635219|3175430|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.86||0.7789|2-Sided|95.0|-1.93|1.45||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724503|NCT00635219|3175431|Superiority or Other||Mean Difference (Final Values)|-0.18|Standard Error of the Mean|0.15||0.2247|2-Sided|95.0|-0.46|0.11||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724504|NCT00635219|3175431|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.14||0.1741|2-Sided|95.0|-0.48|0.09||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724505|NCT00635219|3175431|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.15||0.1794|2-Sided|95.0|-0.48|0.09||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724506|NCT00635219|3175431|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.14||0.2285|2-Sided|95.0|-0.46|0.11||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724507|NCT00635219|3175432|Superiority or Other||Mean Difference (Final Values)|-1.45|Standard Error of the Mean|0.87||0.0981|2-Sided|95.0|-3.16|0.27||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724508|NCT00635219|3175432|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.86||0.7246|2-Sided|95.0|-2.0|1.39||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724509|NCT00635219|3175432|Superiority or Other||Mean Difference (Final Values)|-1.01|Standard Error of the Mean|0.87||0.2434|2-Sided|95.0|-2.72|0.69||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724510|NCT00635219|3175432|Superiority or Other||Mean Difference (Final Values)|-1.12|Standard Error of the Mean|0.86||0.1925|2-Sided|95.0|-2.82|0.57||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724511|NCT00635219|3175433|Superiority or Other||Odds Ratio (OR)|1.05||||0.8563|2-Sided|95.0|0.65|1.69||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.||
1724512|NCT00635219|3175433|Superiority or Other||Odds Ratio (OR)|0.96||||0.8651|2-Sided|95.0|0.59|1.55||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.||
1724513|NCT00635219|3175433|Superiority or Other||Odds Ratio (OR)|1.09||||0.7178|2-Sided|95.0|0.68|1.76||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.||
1724514|NCT00635219|3175433|Superiority or Other||Odds Ratio (OR)|1.13||||0.6258|2-Sided|95.0|0.7|1.81||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.||
1724515|NCT00635219|3175434|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|1.01||0.0768|2-Sided|95.0|-3.79|0.19||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724516|NCT00635219|3175434|Superiority or Other||Mean Difference (Final Values)|-0.99|Standard Error of the Mean|0.99||0.3186|2-Sided|95.0|-2.94|0.96||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724517|NCT00635219|3175434|Superiority or Other||Mean Difference (Final Values)|-1.7|Standard Error of the Mean|0.99||0.0871|2-Sided|95.0|-3.64|0.25||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724518|NCT00635219|3175434|Superiority or Other||Mean Difference (Final Values)|-0.41|Standard Error of the Mean|0.98||0.6748|2-Sided|95.0|-2.35|1.52||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724519|NCT00635219|3175435|Superiority or Other||Mean Difference (Final Values)|-2.6|Standard Error of the Mean|1.53||0.0897|2-Sided|95.0|-5.61|0.41||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724520|NCT00635219|3175435|Superiority or Other||Mean Difference (Final Values)|0.37|Standard Error of the Mean|1.54||0.8093|2-Sided|95.0|-2.65|3.4||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724521|NCT00635219|3175435|Superiority or Other||Mean Difference (Final Values)|-1.15|Standard Error of the Mean|1.49||0.4399|2-Sided|95.0|-4.07|1.77||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724522|NCT00635219|3175435|Superiority or Other||Mean Difference (Final Values)|-1.15|Standard Error of the Mean|1.49||0.4421|2-Sided|95.0|-4.08|1.79||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724523|NCT00635219|3175436|Superiority or Other||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.14||0.1271|2-Sided|95.0|-0.48|0.06||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724524|NCT00635219|3175436|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.14||0.1389|2-Sided|95.0|-0.47|0.07||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724525|NCT00635219|3175436|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.14||0.2114|2-Sided|95.0|-0.44|0.1||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724526|NCT00635219|3175436|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.14||0.1436|2-Sided|95.0|-0.47|0.07||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724556|NCT00634933|3175545|Superiority or Other|||||||0.089|||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724527|NCT00635219|3175437|Superiority or Other||Odds Ratio (OR)|1.52||||0.0765|2-Sided|95.0|0.96|2.4||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.||
1724528|NCT00635219|3175437|Superiority or Other||Odds Ratio (OR)|1.34||||0.2023|2-Sided|95.0|0.85|2.12||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.||
1724529|NCT00635219|3175437|Superiority or Other||Odds Ratio (OR)|1.54||||0.0664|2-Sided|95.0|0.97|2.43||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.||
1724530|NCT00635219|3175437|Superiority or Other||Odds Ratio (OR)|1.41||||0.137|2-Sided|95.0|0.9|2.23||A nominal p-value is provided.|Adjusting for Baseline||No correction for multiplicity was made.||
1724531|NCT00635219|3175438|Superiority or Other||Mean Difference (Final Values)|-2.47|Standard Error of the Mean|1.13||0.0298|2-Sided|95.0|-4.7|-0.24||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724532|NCT00635219|3175438|Superiority or Other||Mean Difference (Final Values)|-1.11|Standard Error of the Mean|1.12||0.3246|2-Sided|95.0|-3.31|1.1||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724533|NCT00635219|3175438|Superiority or Other||Mean Difference (Final Values)|-1.63|Standard Error of the Mean|1.13||0.1487|2-Sided|95.0|-3.85|0.59||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724534|NCT00635219|3175438|Superiority or Other||Mean Difference (Final Values)|-1.79|Standard Error of the Mean|1.13||0.112|2-Sided|95.0|-4.01|0.42||A nominal p-value is provided.|ANCOVA||No correction for multiplicity was made.||
1724535|NCT00635219|3175439|Superiority or Other||Mean Difference (Final Values)|-2.04|Standard Error of the Mean|1.14||0.0741|2-Sided|95.0|-4.27|0.2||This treatment arm was not in the testing sequence. A nominal p-value is provided.|ANCOVA||||
1724536|NCT00635219|3175439|Superiority or Other||Mean Difference (Final Values)|-1.38|Standard Error of the Mean|1.12||0.2187|2-Sided|95.0|-3.59|0.82||This dose was not in the testing sequence. A nominal p-value is provided.|ANCOVA||||
1724537|NCT00635219|3175439|Superiority or Other||Mean Difference (Final Values)|-1.5|Standard Error of the Mean|1.13||0.1847|2-Sided|95.0|-3.73|0.72||Since p-value >0.025, hierarchically testing stopped here.|ANCOVA||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1724538|NCT00635219|3175439|Superiority or Other||Mean Difference (Final Values)|-1.7|Standard Error of the Mean|1.13||0.1321|2-Sided|95.0|-3.92|0.51||Since p-value >0.025, hierarchically testing stopped here.|ANCOVA||To adjust for multiplicity the two doses of vortioxetine were tested separately versus placebo in the primary and key secondary efficacy analyses at a Bonferroni-corrected significance level of 0.025.|As soon as an endpoint was non-significant at the 0.025 level of significance, the testing procedure was stopped for all subsequent endpoints.|
1724539|NCT00635154|3175449|Superiority or Other||Proportion of confirmed responses (%)|1.8||||||95.0|0.5|10.0|||||95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.|Proportion of confirmed responses to Anakinra alone was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.|
1724540|NCT00635050|3175524|Superiority or Other||Hazard Ratio (HR)|0.28|||||2-Sided||||||||||
1724541|NCT00634933|3175530|Superiority or Other|||||||0.003|||||||Cochran-Mantel-Haenszel|||Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724542|NCT00634933|3175530|Superiority or Other|||||||0.034|||||||Cochran-Mantel-Haenszel|||Week 24: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724543|NCT00634933|3175530|Superiority or Other|||||||0.006|||||||Cochran-Mantel-Haenszel|||Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724544|NCT00634933|3175530|Superiority or Other|||||||0.002|||||||Cochran-Mantel-Haenszel|||Week 20: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724545|NCT00634933|3175530|Superiority or Other|||||||0.113|||||||Cochran-Mantel-Haenszel|||Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724546|NCT00634933|3175530|Superiority or Other|||||||0.011|||||||Cochran-Mantel-Haenszel|||Week 16: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724547|NCT00634933|3175530|Superiority or Other|||||||0.019|||||||Cochran-Mantel-Haenszel|||Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724548|NCT00634933|3175530|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel|||Week 12: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724549|NCT00634933|3175530|Superiority or Other|||||||0.105|||||||Cochran-Mantel-Haenszel|||Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724550|NCT00634933|3175530|Superiority or Other|||||||0.255|||||||Cochran-Mantel-Haenszel|||Week 8: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724551|NCT00634933|3175530|Superiority or Other|||||||0.25|||||||Cochran-Mantel-Haenszel|||Week 4: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724552|NCT00634933|3175530|Superiority or Other|||||||0.059|||||||Cochran-Mantel-Haenszel|||Week 4 Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724553|NCT00634933|3175530|Superiority or Other|||||||0.322|||||||Cochran-Mantel-Haenszel|||Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724554|NCT00634933|3175530|Superiority or Other|||||||0.106|||||||Cochran-Mantel-Haenszel|||Week 2: Good response- A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724555|NCT00634933|3175545|Superiority or Other|||||||0.079|||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724871|NCT00626522|3176520|Superiority or Other||Least squares mean difference|0.265|Standard Error of the Mean|0.038|<|0.0001|2-Sided|95.0|0.191|0.34|||ANCOVA||||
1724557|NCT00634933|3175545|Superiority or Other|||||||0.268|||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724558|NCT00634933|3175545|Superiority or Other|||||||0.249|||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724559|NCT00634933|3175545|Superiority or Other|||||||0.977|||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724560|NCT00634933|3175545|Superiority or Other|||||||0.768|||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724561|NCT00634933|3175545|Superiority or Other|||||||0.563|||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724562|NCT00634933|3175545|Superiority or Other|||||||0.573|||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724563|NCT00634933|3175545|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724564|NCT00634933|3175545|Superiority or Other|||||||0.575|||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724565|NCT00634933|3175545|Superiority or Other|||||||0.296|||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724566|NCT00634933|3175545|Superiority or Other|||||||0.983|||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724567|NCT00634933|3175545|Superiority or Other|||||||0.338|||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724568|NCT00634933|3175545|Superiority or Other|||||||0.325|||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724569|NCT00634933|3175546|Superiority or Other|||||||0.082|||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724570|NCT00634933|3175546|Superiority or Other|||||||0.086|||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724571|NCT00634933|3175546|Superiority or Other|||||||0.035|||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724572|NCT00634933|3175546|Superiority or Other|||||||0.042|||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724573|NCT00634933|3175546|Superiority or Other|||||||0.814|||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724574|NCT00634933|3175546|Superiority or Other|||||||0.88|||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724575|NCT00634933|3175546|Superiority or Other|||||||0.456|||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724576|NCT00634933|3175546|Superiority or Other|||||||0.77|||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724577|NCT00634933|3175546|Superiority or Other|||||||0.966|||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724578|NCT00634933|3175546|Superiority or Other|||||||0.794|||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724579|NCT00634933|3175546|Superiority or Other|||||||0.025|||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724580|NCT00634933|3175546|Superiority or Other|||||||0.014|||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724581|NCT00634933|3175547|Superiority or Other|||||||0.005|||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724582|NCT00634933|3175547|Superiority or Other|||||||0.03|||||||Cochran-Mantel-Haenszel|||Week 24: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724583|NCT00634933|3175547|Superiority or Other|||||||0.049|||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724584|NCT00634933|3175547|Superiority or Other|||||||0.062|||||||Cochran-Mantel-Haenszel|||Week 20: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724585|NCT00634933|3175547|Superiority or Other|||||||0.021|||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724586|NCT00634933|3175547|Superiority or Other|||||||0.006|||||||Cochran-Mantel-Haenszel|||Week 16: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724587|NCT00634933|3175547|Superiority or Other|||||||0.029|||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724588|NCT00634933|3175547|Superiority or Other|||||||0.01|||||||Cochran-Mantel-Haenszel|||Week 12: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724589|NCT00634933|3175547|Superiority or Other|||||||0.174|||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724590|NCT00634933|3175547|Superiority or Other|||||||0.108|||||||Cochran-Mantel-Haenszel|||Week 8: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724591|NCT00634933|3175547|Superiority or Other|||||||0.671|||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724592|NCT00634933|3175547|Superiority or Other|||||||0.616|||||||Cochran-Mantel-Haenszel|||Week 4: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724593|NCT00634933|3175547|Superiority or Other|||||||0.2|||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724594|NCT00634933|3175547|Superiority or Other|||||||0.57|||||||Cochran-Mantel-Haenszel|||Week 2: A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724595|NCT00634933|3175548|Superiority or Other|||||||0.12|||||||Cochran-Mantel-Haenszel|||A 2-sided CMH test, stratified by prior anti-TNF use and geographic region, was used.|
1724596|NCT00634933|3175548|Superiority or Other|||||||0.061|||||||Cochran-Mantel-Haenszel|||A 2-sided Cochran-Mantel-Haenszel test (CMH), stratified by prior anti-tumor necrosis factor (anti-TNF) use and geographic region, was used.|
1724597|NCT00634842|3175578|Superiority or Other||LSMean|-0.271||||0.0019||95.0|-0.441|-0.101|||ANCOVA|The analyses for HbA1c were adjusted for baseline HbA1c values.|||
1724598|NCT00634842|3175579|Non-Inferiority or Equivalence|The hypothesis was that there would be no difference in efficacy as measured by the proportion of subjects reaching HbA1c level <= 6.5% between the two FPG titration arms (70-90 mg/dL and 80-110 mg/dL, respectively) with a non-inferiority margin of 20%. If non-inferiority of the 70-90mg/dL arm was established, superiority was to be tested using a Logistic regression model with baseline HbA1c as a covariate. Superiority was to be concluded if the odds ratio was significantly greater than 1.|Odds Ratio (OR)|2.34||||0.0064||95.0|1.27|4.3|||Regression, Logistic||||
1724599|NCT00634842|3175580|Non-Inferiority or Equivalence|The primary hypothesis was that there would be no difference in efficacy as measured by the proportion of subjects reaching HbA1c level < 7% between the two FPG titration arms (70-90 mg/dL and 80-110 mg/dL, respectively) with a non-inferiority margin of 20%. If non-inferiority of the 70-90mg/dL arm was established, superiority was to be tested using a Logistic regression model with baseline HbA1c as a covariate. Superiority was to be concluded if the odds ratio was significantly greater than 1.|Odds Ratio (OR)|1.86||||0.0411||95.0|1.03|3.37|||Test for Difference in Proportions|||To show non-inferiority for the primary endpoint, 100 subjects per group provides 80% power to show that the 95% CI for the difference of proportions between treatments is within the 20% margin under the assumption of equality of proportions. It is also sufficient to show superiority under the assumption that the first proportion is greater than the second by at least 20%. With a predicted withdrawal rate of 15%, 236 subjects were needed based on a treatment ratio of 1:1 for the two treatments.|
1724600|NCT00634543|3175600|Superiority or Other|||||||0.569|||||||Chi-squared|P-value was evaluated for all categories (bad, no change, good and very good).|||
1724601|NCT00634543|3175601|Superiority or Other|||||||0.3504|||||||Chi-squared|P-value was evaluated for all categories (bad, no change, good and very good).|||
1724602|NCT00634543|3175602|Superiority or Other|||||||0.7407|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 43.|||
1724603|NCT00634543|3175602|Superiority or Other|||||||0.5905|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 29.|||
1724604|NCT00634543|3175602|Superiority or Other|||||||0.7539|||||||Chi-squared|P-value was evaluated for pain relief in tramadol hydrochloride/ acetaminophen versus gabapentin groups at Day 15.|||
1724605|NCT00634543|3175603|Non-Inferiority or Equivalence|Non inferiority was demonstrated if lower confidence limit of 2-sided 95% CI was less than the non-inferiority margin of 1.39.|Mean Difference (Net)|0.39||||0.2143|2-Sided|95.0|-0.23|1.01|||t-test, 2 sided|P-value was calculated for change from baseline in pain intensity score at Day 43.|||
1724606|NCT00634283|3175607|Superiority|||||||0.32||||||The a priori threshold was set at 0.05, 2-tailed, without adjustment for multiple comparisons.|t-test, 2 sided|||Change in PFC over the one-week placebo lead-in period was compared between antidepressant-experienced and antidepressant-naive groups using a between groups t-test.|"Group differences in PFC changes over time during administration of venlafaxine were assessed using mixed-model analysis.~we compared brain functional changes over the course of venlafaxine treatment between antidepressant-experienced and antidepressant-naïve subjects using linear mixed model analysis (random intercept model) conducted using full maximum likelihood estimation (MLE). Changes in PFC were calculated from the end of placebo lead-in to 48 hours, and 1, 2, and 4 weeks, yielding a within-group factor of time with four levels. We employed a first-order autoregressive covariance structure to reflect our assumption that PFC measurements closer together in time would be more highly correlated."
1724607|NCT00634283|3175607|Superiority|||||||0.55|||||||t-test, 2 sided||||
1724608|NCT00633919|3175672|Superiority or Other||||||>|0.05|||||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.|
1724609|NCT00633919|3175673|Superiority or Other|||||||0.0486|||||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.|
1724610|NCT00633919|3175674|Superiority or Other||||||>|0.05|||||||Proportional odds regression|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.|
1724611|NCT00633919|3175675|Superiority or Other|||||||0.52|||||||Linear mixed effect (LME) model|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.|
1724612|NCT00633919|3175676|Superiority or Other|||||||0.85|||||||Linear mixed effect (LME) model|||The null hypothesis is the hypothesis of no difference and the alternative to the null hypothesis is the hypothesis of a difference.|
1724613|NCT00633893|3175684|Superiority or Other||Risk Ratio (RR)|1.6468||||0.0005|2-Sided|95.0|1.2552|2.1606||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding is any major, clinically relevant non-major, or minor bleeding.|
1724614|NCT00633893|3175684|Superiority or Other||Risk Ratio (RR)|1.2374||||0.1466|2-Sided|95.0|0.9276|1.6507||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with total bleeding to proportion of placebo participants with total bleeding equal to 1.0. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding.|
1724922|NCT00624520|3176816|Superiority or Other||Mean Difference (Final Values)|15.0||||0.01|2-Sided||||||ANOVA||||
1724615|NCT00633893|3175685|Superiority or Other||Risk Ratio (RR)|1.6971||||0.0013|2-Sided|95.0|1.2468|2.3102||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.|
1724616|NCT00633893|3175685|Superiority or Other||Risk Ratio (RR)|1.2579||||0.1691|2-Sided|95.0|0.9064|1.7457||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with minor bleeding to proportion of placebo participants with minor bleeding equal to 1.0.|
1724617|NCT00633893|3175686|Superiority or Other||Risk Ratio (RR)|1.8235||||0.0621||95.0|1.047|3.176||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.|
1724618|NCT00633893|3175686|Superiority or Other||Risk Ratio (RR)|1.2928||||0.3932|2-Sided|95.0|0.7158|2.3348||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with clinically relevant non-major bleeding to proportion of placebo participants with clinically relevant non-major bleeding equal to 1.0.|
1724619|NCT00633893|3175687|Superiority or Other||Risk Ratio (RR)|1.616||||0.1412|2-Sided|95.0|0.9554|2.7336||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.|
1724620|NCT00633893|3175687|Superiority or Other||Risk Ratio (RR)|1.2027||||0.5148|2-Sided|95.0|0.6897|2.0975||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major/clinically relevant non-major bleeding to proportion of placebo participants with major/clinically relevant non-major bleeding equal to 1.0.|
1724621|NCT00633893|3175688|Superiority or Other||Risk Ratio (RR)|0.2457||||0.3551|2-Sided|95.0|0.0269|2.2437||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Participants treated with at least one dose of study drug were included.|
1724622|NCT00633893|3175688|Superiority or Other||Risk Ratio (RR)|0.485||||0.3925|2-Sided|95.0|0.0891|2.6391||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with major bleeding to proportion of placebo participants with major bleeding equal to 1.0. Treated participants with at least one dose of study drug were included.|
1724623|NCT00633893|3175690|Superiority or Other||Risk Ratio (RR)|0.7708||||0.3155|2-Sided|95.0|0.4631|1.2832||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.|
1724624|NCT00633893|3175690|Superiority or Other||Risk Ratio (RR)|0.6577||||0.2361|2-Sided|95.0|0.3874|1.1169||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with all cause mortality to proportion of placebo participants with all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.|
1724625|NCT00633893|3175691|Superiority or Other||Risk Ratio (RR)|0.8433||||0.5288|2-Sided|95.0|0.4959|1.4341||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.|
1724626|NCT00633893|3175691|Superiority or Other||Risk Ratio (RR)|0.5794||||0.1316|2-Sided|95.0|0.3215|1.0443||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with CV-related death to proportion of placebo participants with CV-related death equal to 1.0. Participants with missing data were assumed to have experienced CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.|
1724681|NCT00631969|3175912|Superiority or Other||Cochran-Mantel-Haenszel|74.449|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for pooled centers and age group.||Statistical analysis applies to the total population.|
1724627|NCT00633893|3175692|Superiority or Other||Risk Ratio (RR)|0.9416||||0.8288|2-Sided|95.0|0.5458|1.6245||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.|
1724628|NCT00633893|3175692|Superiority or Other||Risk Ratio (RR)|0.647||||0.3059|2-Sided|95.0|0.3543|1.1813||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE-related death to proportion of placebo participants with VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.|
1724629|NCT00633893|3175693|Superiority or Other||Risk Ratio (RR)|0.6846||||0.1329|2-Sided|95.0|0.4164|1.1257||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.|
1724630|NCT00633893|3175693|Superiority or Other||Risk Ratio (RR)|0.6087||||0.1084|2-Sided|95.0|0.3653|1.0145||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal PE to proportion of placebo participants with nonfatal PE equal to 1.0. Participants with missing data were assumed to have experienced nonfatal PE. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.|
1724631|NCT00633893|3175694|Superiority or Other||Risk Ratio (RR)|0.3972|||<|0.0001|2-Sided|95.0|0.2595|0.6079||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.|
1724632|NCT00633893|3175694|Superiority or Other||Risk Ratio (RR)|0.2615|||<|0.0001|2-Sided|95.0|0.1593|0.4292||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with nonfatal DVT to proportion of placebo participants with nonfatal DVT equal to 1.0. Participants with missing data were assumed to have experienced nonfatal DVT. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.|
1724633|NCT00633893|3175695|Superiority or Other||Risk Ratio (RR)|0.3653|||<|0.0001|2-Sided|95.0|0.25|0.5338||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.|
1724634|NCT00633893|3175695|Superiority or Other||Risk Ratio (RR)|0.2799|||<|0.0001|2-Sided|95.0|0.1844|0.4247||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/CV-related death to proportion of placebo participants with VTE/CV-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/CV-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.|
1724635|NCT00633893|3175696|Superiority or Other||Risk Ratio (RR)|0.1861|||<|0.0001|2-Sided|95.0|0.1062|0.3261||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.|
1724636|NCT00633893|3175696|Superiority or Other||Risk Ratio (RR)|0.2422|||<|0.0001|2-Sided|95.0|0.1476|0.3975||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.|
1724637|NCT00633893|3175697|Superiority or Other||Risk Ratio (RR)|0.3774|||<|0.0001|2-Sided|95.0|0.2577|0.5525||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.|
1724638|NCT00633893|3175697|Superiority or Other||Risk Ratio (RR)|0.2891|||<|0.0001|2-Sided|95.0|0.1902|0.4395||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/VTE-related death to proportion of placebo participants with VTE/ VTE-related death equal to 1.0. Participants with missing data were assumed to have experienced VTE/ VTE-related death. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, ITT principle.|
1724639|NCT00633893|3175698|Superiority or Other||Risk Ratio (RR)|0.3615|||<|0.0001|2-Sided|95.0|0.2475|0.5281||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat principle.|
1724640|NCT00633893|3175698|Superiority or Other||Risk Ratio (RR)|0.3283|||<|0.0001|2-Sided|95.0|0.2225|0.4844||Hochberg adjusted p-value for superiority based on 2 hypotheses tests for apixaban 2.5mg group comparing with placebo group and for apixaban 5mg group comparing with placebo group.|Cochran-Mantel-Haenszel|||Null hypothesis is relative risk proportion of apixaban participants with VTE/all cause mortality to proportion of placebo participants with VTE/all cause mortality equal to 1.0. Participants with missing data were assumed to have experienced VTE/all cause mortality. Events occurring anytime during the intended treatment period (12 months) were included regardless of whether the participant was on treatment or not or whether the participant ever took drug, ie, Intent to treat (ITT) principle.|
1724641|NCT00633880|3175704|Superiority or Other|||||||0.026|||||||Wilcoxon (Mann-Whitney)||||
1724642|NCT00633880|3175709|Superiority or Other|||||||0.509||||||Statistical analysis plan involved a hierarchical assessment of secondary endpoints to prevent inflation of type I errors. As the primary endpoint was not positive, statistical analysis was not performed on secondary endpoints.|Wilcoxon (Mann-Whitney)||||
1724643|NCT00633867|3175710|Superiority or Other||||||<|0.01|||||||Log Rank||||
1724644|NCT00633360|3175749|Superiority or Other|||||||0.29|||||||t-test, 2 sided||||
1724645|NCT00633360|3175750|Superiority or Other|||||||0.59|||||||Wilcoxon (Mann-Whitney)||||
1724646|NCT00633217|3175757|Non-Inferiority or Equivalence|If the lower bound of the 95% confidence interval for the mean difference in 2-hour post-dose FEV1 change from baseline fell above -75 mL, then HFA MDI could be deemed non-inferior to DISKUS treatment response.||||||0.021|||||||ANCOVA||||
1724647|NCT00633139|3175767|Superiority or Other|||||||0.1363|||||||ANCOVA||||
1724648|NCT00633139|3175768|Superiority or Other|||||||0.275|||||||ANCOVA||||
1724649|NCT00633139|3175769|Superiority or Other|||||||0.4013|||||||ANCOVA||||
1724650|NCT00633022|3175798|Superiority||Mean Difference (Final Values)|0.0||||0.9486|2-Sided|95.0|-0.13|0.12|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg once daily and Placebo.|Losmapimod 7.5 mg once daily versus Placebo|
1724651|NCT00633022|3175798|Superiority||Mean Difference (Final Values)|-0.02||||0.6986|2-Sided|95.0|-0.15|0.1|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg twice daily and Placebo.|Losmapimod 7.5 mg twice daily versus placebo|
1724652|NCT00633022|3175799|Superiority||Mean Difference (Final Values)|-0.02||||0.5789|2-Sided|95.0|-0.11|0.06|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg once daily and Placebo.|Losmapimod 7.5 mg once daily versus Placebo|
1724653|NCT00633022|3175799|Superiority||Mean Difference (Final Values)|-0.04||||0.4519|2-Sided|95.0|-0.14|0.06|||ANCOVA|ANCOVA model, fitting fixed effect treatment term, and including baseline TBR value as a covariate.ANCOVA model, fitting fixed effect treatment term,|The point estimate was calculated as least square mean difference (final values) of Losmapimod 7.5 mg twice daily and Placebo.|Losmapimod 7.5 mg BID versus Placebo|
1724654|NCT00632931|3175804|Superiority or Other||Mean Difference (Final Values)|6.51||||||90.0|3.19|9.82|||||||
1724655|NCT00632931|3175805|Superiority or Other||Mean Difference (Final Values)|2.66||||||90.0|-0.7|6.02|||||||
1724656|NCT00632931|3175806|Superiority or Other||Mean Difference (Final Values)|4.33||||||90.0|1.05|7.6|||||||
1724657|NCT00632931|3175807|Superiority or Other||Mean Difference (Final Values)|6.44||||||90.0|3.21|9.68|||||||
1724658|NCT00632931|3175808|Superiority or Other||Mean Difference (Final Values)|2.84||||||90.0|-0.4|6.08|||||||
1724659|NCT00632931|3175809|Superiority or Other||Mean Difference (Final Values)|3.07||||||90.0|-0.17|6.31|||||||
1724660|NCT00632931|3175810|Superiority or Other||Mean Difference (Final Values)|1.45||||||90.0|-1.38|4.72|||||||
1724661|NCT00632931|3175811|Superiority or Other||Mean Difference (Final Values)|3.0||||||90.0|-0.28|6.28|||||||
1724682|NCT00631969|3175913|Superiority or Other||Mean Difference (Final Values)|-33.076|||<|0.0001||95.0|-38.745|-27.407|||ANCOVA|||Statistical analysis applies to the total population.|
1724923|NCT00624520|3176817|Superiority or Other||Mean Difference (Final Values)|-11.0||||0.01|2-Sided||||||ANOVA||||
1724662|NCT00632619|3175853|Superiority or Other|||||||0.095|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.|
1724663|NCT00632619|3175854|Superiority or Other|||||||0.016|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.|
1724664|NCT00632619|3175855|Superiority or Other|||||||0.38|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was conducted to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.|
1724665|NCT00632619|3175856|Superiority or Other|||||||0.015|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline which was week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.|
1724666|NCT00632619|3175857|Superiority or Other|||||||0.106|||||||ANOVA|||A 2 x 2 repeated measures analysis (with time as within-subject factor and group as between-subject factor) was performed to compare the two groups on this measure at two time points (i.e., baseline at week 0 and endpoint at week 12) and infer treatment success accordingly. The null hypothesis signified that there would be no difference between the groups over time, thus, there would be no difference in treatments. Statistical power was calculated as Cohen's d.|
1724667|NCT00632229|3175895|Superiority or Other||||||<|0.05|||||||ANCOVA|||To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.|
1724668|NCT00632229|3175896|Superiority or Other||||||<|0.05|||||||ANCOVA|||To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.|
1724669|NCT00632203|3175903|Superiority or Other|||||||0.6995|||||||2-sided Exact Pearson Chi-square Test||||
1724670|NCT00632099|3175905|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1724671|NCT00632021|3175906|Equivalence|The association between intervention and time to first unplanned health care event (hospital readmission) was examined using multivariable Cox proportional hazards regression models.|Cox Proportional Hazard|0.94|||||2-Sided|95.0|0.63|1.28|||||||
1724672|NCT00632021|3175907|Equivalence|In the primary analysis we compared the number of clinically important medication errors by treatment group using unadjusted negative binomial regression.|Incidence Rate Ratio (IRR)|0.92|||||2-Sided|95.0|0.77|1.09|||||||
1724673|NCT00631969|3175908|Non-Inferiority or Equivalence|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.394|||||||Regression, Linear|||A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.|
1724674|NCT00631969|3175908|Non-Inferiority or Equivalence|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|123.84||||||90.0|80.12|191.42||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged < 65 years) were calculated.|
1724675|NCT00631969|3175909|Non-Inferiority or Equivalence|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.7375|||||||Regression, Linear|||A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.|
1724676|NCT00631969|3175909|Non-Inferiority or Equivalence|This is an exploratory analysis of metabolite M-1 exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|125.28||||||90.0|73.65|213.11||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years/ patients aged < 65 years) were calculated.|
1724677|NCT00631969|3175910|Non-Inferiority or Equivalence|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.8749|||||||Regression, Linear|||A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.|
1724678|NCT00631969|3175910|Non-Inferiority or Equivalence|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|133.07||||||90.0|87.46|202.46||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged < 65 years) were calculated.|
1724679|NCT00631969|3175911|Non-Inferiority or Equivalence|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.||||||0.7064|||||||Regression, Linear|||A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.|
1724680|NCT00631969|3175911|Non-Inferiority or Equivalence|This is an exploratory analysis of Vardenafil exposure in ED patients of different age categories to assess the effect of age on the drug's pharmacokinetics.|Point estimate of ratio|117.42||||||90.0|79.59|173.23||||||Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged < 65 years) were calculated.|
1724683|NCT00631969|3175914|Superiority or Other||Mean Difference (Final Values)|-23.384|||<|0.0001||95.0|-28.594|-18.175|||ANCOVA|||Statistical analysis applies to the total population.|
1724684|NCT00631969|3175915|Superiority or Other||Mean Difference (Final Values)|-23.326|||<|0.0001||95.0|-29.062|-17.598|||ANCOVA|||Statistical analysis applies to the total population.|
1724685|NCT00631969|3175916|Superiority or Other||Mean Difference (Final Values)|-27.775|||<|0.0001||95.0|-33.155|-22.394|||ANCOVA|||Statistical analysis applies to the total population.|
1724686|NCT00631969|3175917|Superiority or Other||Mean Difference (Final Values)|-24.496|||<|0.0001||95.0|-34.865|-24.128|||ANCOVA|||Statistical analysis applies to the total population.|
1724687|NCT00631969|3175918|Superiority or Other||Mean Difference (Final Values)|-24.703|||<|0.0001||95.0|-30.067|-19.34|||ANCOVA|||Statistical analysis applies to the total population.|
1724688|NCT00631969|3175920|Superiority or Other||Mean Difference (Final Values)|-25.193|||<|0.0001||95.0|-31.562|-18.824|||ANCOVA|||Statistical analysis applies to the total population.|
1724689|NCT00631969|3175921|Superiority or Other||Mean Difference (Final Values)|-36.555|||<|0.0001||95.0|-43.645|-29.465|||ANCOVA|||Statistical analysis applies to the total population.|
1724690|NCT00631969|3175922|Superiority or Other||Mean Difference (Final Values)|-38.167|||<|0.0001||95.0|-45.261|-31.073|||ANCOVA|||Statistical analysis applies to the total population.|
1724691|NCT00631969|3175923|Superiority or Other||Mean Difference (Final Values)|-16.503|||<|0.0001||95.0|-22.424|-10.764|||ANCOVA|||Statistical analysis applies to the total population.|
1724692|NCT00631969|3175924|Superiority or Other||Cochran-Mantel-Haenszel|34.778|||<|0.0001||95.0|||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) adjusted for age group and pooled center.||Statistical analysis applies to the total population.|
1724693|NCT00631969|3175925|Superiority or Other||Mean Difference (Final Values)|-38.193|||<|0.0001||95.0|-45.021|-31.366|||ANCOVA|||Statistical analysis applies to the total population.|
1724694|NCT00631969|3175926|Superiority or Other||Mean Difference (Final Values)|-29.027|||<|0.0001||95.0|-35.519|-22.534|||ANCOVA|||Statistical analysis applies to the total population.|
1724695|NCT00631969|3175927|Superiority or Other||Mean Difference (Final Values)|-7.109|||<|0.0001||95.0|-8.562|-5.6561|||ANCOVA|||Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.|
1724696|NCT00631748|3175933|Superiority or Other|||||||0.65|||||||Regression, Cox|||End-of-trial abstinence was defined as a negative urine drug screen (for cocaine) for three consecutive weeks at the end of the study.|
1724697|NCT00631748|3175934|Superiority or Other||||||<|0.25|||||||ANCOVA|We compared TLFB at baseline and at end of study.||We used a repeated-measures ANCOVA to compare cocaine usage between the two groups. This incorporated the multiple administrations of the Timeline Followback measure.|
1724698|NCT00631696|3175935|Superiority or Other||LS Mean Difference|-0.86||||0.4666|2-Sided|95.0|-3.207|1.477||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).||
1724699|NCT00631696|3175936|Superiority or Other||LS Mean Difference|-0.15||||0.9064|2-Sided|95.0|-2.649|2.352||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).||
1724700|NCT00631696|3175937|Superiority or Other||LS Mean Difference|-1.08||||0.4094|2-Sided|95.0|-3.645|1.494||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).||
1724701|NCT00631696|3175938|Superiority or Other||LS Mean Difference|-6.12||||0.7958|2-Sided|95.0|-52.804|40.558||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).||
1724702|NCT00631696|3175939|Superiority or Other||LS Mean Difference|32.93||||0.1699|2-Sided|95.0|-14.292|80.158||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).||
1724703|NCT00631696|3175940|Superiority or Other||LS Mean Difference|24.65||||0.2875|2-Sided|95.0|-20.999|70.302||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).||
1724704|NCT00631696|3175941|Superiority or Other||LS Mean Difference|-0.2||||0.1204|2-Sided|95.0|-0.464|0.054||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).||
1724705|NCT00631696|3175942|Superiority or Other||LS Mean Difference|-0.13||||0.3652|2-Sided|95.0|-0.42|0.156||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).||
1724706|NCT00631696|3175943|Superiority or Other||LS Mean Difference|-0.12||||0.3462|2-Sided|95.0|-0.385|0.136||p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.|ANCOVA||Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).||
1724750|NCT00630825|3176097|Superiority or Other||||||<|0.001||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724707|NCT00631696|3175944|Non-Inferiority or Equivalence|A non-inferiority margin of 20% was used to test the hypothesis. The null hypothesis is that the difference (PGB - PBO) in the proportion of participants with ≥50% reduction in sperm concentration is ≥20% and the alternative hypothesis is that the difference in proportion of participant with ≥50% reduction in sperm concentration is <20%.|percentage difference|6.0|||||2-Sided|95.0|-2.29|14.3|||||The confidence interval was based on asymptotic normal distribution.|Study powered to show non-inferiority (NI) of pregabalin (PGB) to placebo (PBO) on the percentage of participants (N) with a ≥50% reduction in MSC from Bsl to end of washout (Week (Wk) 26, or last assessment on or after Wk 12 if Wk 26 not done). NI to be declared if upper bound of 95% CI for difference between PGB and PBO not >20%. Assuming proportion of N with 50% reduction to be 6% for both groups, sample size N=65 per group would provide >90% power to show NI of PGB to PBO.|
1724708|NCT00631657|3175956|Superiority or Other||Difference in LS Means|-25.0|||<|0.0001|2-Sided|95.0|-34.5|-15.4|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline WASO as covariate.||
1724709|NCT00631657|3175957|Superiority or Other||Difference in LS Means|-4.9||||0.2145|2-Sided|95.0|-12.6|2.8|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline SL as covariate.||
1724710|NCT00631657|3175960|Superiority or Other||Difference in Least Squares (LS) Means|48.7|||<|0.0001|2-Sided|95.0|35.0|62.5|||ANCOVA||ANCOVA performed with fixed effects for treatment and (pooled) center as factors and baseline TST as covariate.||
1724711|NCT00631540|3175970|Superiority or Other||Mean Patency Rate|91.7|||<|0.0001|2-Sided|95.0|84.2|95.9|||Z-test, 1-sided||GEE model estimate.|Alternative hypothesis is 9-month primary patency rate greater than 60%.|
1724712|NCT00631488|3175971|Superiority or Other||Mean Difference (Final Values)|-11.3|||<|0.001|2-Sided|95.0|-14.1|-8.5|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-Hour Active GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Active GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.|
1724713|NCT00631488|3175971|Superiority or Other||Mean Difference (Final Values)|-6.7|||<|0.001|2-Sided|95.0|-9.5|-3.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-Hour Active GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Active GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference|
1724714|NCT00631488|3175972|Superiority or Other||Mean Difference (Final Values)|13.2|||<|0.001|2-Sided|95.0|10.7|15.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-Hour Total GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Total GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.|
1724715|NCT00631488|3175972|Superiority or Other||Mean Difference (Final Values)|4.2|||<|0.001|2-Sided|95.0|1.7|6.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-Hour Total GLP-1 Total AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants/group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Total GLP-1 Total AUC between any 2 treatment groups for a 2-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% CI for the between group difference.|
1724716|NCT00631488|3175973|Superiority or Other||Mean Difference (Final Values)|-44.6|||<|0.001|2-Sided|95.0|-67.3|-21.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 2-hr Glucose AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Glucose Total AUC between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.|
1724717|NCT00631488|3175973|Superiority or Other||Mean Difference (Final Values)|22.6|||<|0.056|2-Sided|95.0|-0.6|45.8|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 2-hr Glucose AUC than sitagliptin+metformin. Using a SD of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 2-Hour Glucose Total AUC between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.|
1724718|NCT00631488|3175974|Superiority or Other||Mean Difference (Final Values)|-19.1|||<|0.001|2-Sided|95.0|-28.0|-10.1|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 24-hour FPG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour FPG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.|
1724719|NCT00631488|3175974|Superiority or Other||Mean Difference (Final Values)|9.1|||<|0.05|2-Sided|95.0|0.0|18.2|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 24-hour FPG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour FPG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.|
1724751|NCT00630825|3176097|Superiority or Other||||||<|0.001||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724752|NCT00630825|3176098|Superiority or Other||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724720|NCT00631488|3175975|Superiority or Other||Mean Difference (Final Values)|-17.8|||<|0.001|2-Sided|95.0|-26.5|-9.2|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+metformin provide greater reduction in 24-hour WMG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour WMG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval for the between group difference.|
1724721|NCT00631488|3175975|Superiority or Other||Mean Difference (Final Values)|13.9|||<|0.002|2-Sided|95.0|5.2|22.7|||Longitudinal Data Analysis|||Hypothesis: After 4 weeks of treatment, MK-0893+sitagliptin provide greater reduction in 24-hour WMG than sitagliptin+metformin. Using a standard deviation (SD) of 23.5 mg/dL, a sample size of 40 participants per group had 80% power to detect a true difference of 15 mg/dL in the mean change from BL in 24-hour WMG between any 2 treatment groups for a two-sided test at alpha=0.05, with a half-width of 10.3 mg/dL around the 95% confidence interval (CI) for the between group difference.|
1724722|NCT00631371|3175992|Superiority or Other||Hazard Ratio (HR)|1.0||||0.6|2-Sided|95.0|0.9|1.3|||Log Rank|||P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy [yes/no] and MSKCC risk factors [good/intermediate/poor] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.|
1724723|NCT00631371|3175993|Superiority or Other||Risk Ratio (RR)|1.0||||1|2-Sided|95.0|0.8|1.3|||Cochran-Mantel-Haenszel|||P-value (2-sided), risk ratio and associated 95% CI were based on Cochran-Mantel-Haenszel test stratified by prior nephrectomy and MSKCC risk group as randomized.|
1724724|NCT00631371|3175994|Superiority or Other||Hazard Ratio (HR)|1.1||||0.9|2-Sided|95.0|1.0|1.4|||Log Rank|||P-value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy [yes/no] and MSKCC risk factors [good/intermediate/poor] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.|
1724725|NCT00631371|3175995|Superiority or Other||Hazard Ratio (HR)|1.1||||0.8|2-Sided|95.0|0.9|1.3|||Log Rank|||P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy [yes/no] and Memorial Sloan Kettering Cancer Center [MSKCC] risk factors [good/intermediate/poor] at time of randomization). The hazard ratio and corresponding 95 percent (%) confidence interval (CI) from the stratified cox proportional hazard model were also presented.|
1724726|NCT00630877|3176041|Superiority or Other||||||<|0.001|||||||Independent groups t-test||||
1724727|NCT00630877|3176042|Superiority or Other|||||||0.002|||||||Independent groups t-test||||
1724728|NCT00630877|3176043|Superiority or Other||||||<|0.0001|||||||Spearman rank-order correlation||||
1724729|NCT00630877|3176044|Superiority or Other||||||<|0.0001|||||||Spearman rank-order correlation||||
1724730|NCT00630877|3176045|Superiority or Other||||||<|0.0001|||||||Spearman rank-order correlation||||
1724731|NCT00630877|3176046|Superiority or Other||||||<|0.0001|||||||Spearman rank-order correlation||||
1724732|NCT00630877|3176048|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1724733|NCT00630838|3176085|Superiority or Other||||||=|0|||||||t-test, 2 sided||||
1724734|NCT00630825|3176094|Superiority or Other|||||||0.047||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724735|NCT00630825|3176094|Superiority or Other|||||||0.028||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724736|NCT00630825|3176094|Superiority or Other|||||||0.009||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724737|NCT00630825|3176095|Superiority or Other|||||||0.001||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724738|NCT00630825|3176095|Superiority or Other|||||||0.004||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724739|NCT00630825|3176095|Superiority or Other||||||<|0.001||||||Treatment comparison at 16 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724740|NCT00630825|3176095|Superiority or Other||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724741|NCT00630825|3176095|Superiority or Other||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724742|NCT00630825|3176095|Superiority or Other||||||<|0.001||||||Treatment comparison at 8 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724743|NCT00630825|3176095|Superiority or Other||||||<|0.113||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724744|NCT00630825|3176095|Superiority or Other||||||<|0.001||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724745|NCT00630825|3176095|Superiority or Other||||||<|0.001||||||Treatment comparison at 4 weeks. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724746|NCT00630825|3176097|Superiority or Other|||||||0.729||||||Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724747|NCT00630825|3176097|Superiority or Other|||||||0.138|||||||ANCOVA|Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|||
1724748|NCT00630825|3176097|Superiority or Other|||||||0.904||||||Treatment comparison of HOMA2-%S. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724749|NCT00630825|3176097|Superiority or Other|||||||0.004||||||Treatment comparison of HOMA2-%B. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724924|NCT00624520|3176818|Superiority or Other||Mean Difference (Final Values)|-4.0||||0.048|2-Sided||||||ANOVA||||
1724753|NCT00630825|3176098|Superiority or Other||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724754|NCT00630825|3176098|Superiority or Other||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724755|NCT00630825|3176098|Superiority or Other||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724756|NCT00630825|3176098|Superiority or Other||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724757|NCT00630825|3176098|Superiority or Other||||||<|0.001||||||Treatment comparison at Week 8. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724758|NCT00630825|3176098|Superiority or Other||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724759|NCT00630825|3176098|Superiority or Other||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724760|NCT00630825|3176098|Superiority or Other||||||<|0.001||||||Treatment comparison at Week 4. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724761|NCT00630825|3176099|Superiority or Other|||||||0.025||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724762|NCT00630825|3176099|Superiority or Other|||||||0.047||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724763|NCT00630825|3176099|Superiority or Other||||||<|0.001||||||Treatment comparison at Week 16. P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724764|NCT00630825|3176100|Superiority or Other||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724765|NCT00630825|3176100|Superiority or Other||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724766|NCT00630825|3176100|Superiority or Other||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724767|NCT00630825|3176101|Superiority or Other||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724768|NCT00630825|3176101|Superiority or Other||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724769|NCT00630825|3176101|Superiority or Other||||||<|0.001||||||P-values ≤0.05 were considered significant. No adjustment for multiple comparisons was performed.|ANCOVA||||
1724770|NCT00630734|3176118|Superiority or Other|||||||0.08|||||||ANOVA||||
1724771|NCT00630734|3176119|Superiority or Other|||||||0.006|||||||ANOVA||||
1724772|NCT00630734|3176120|Superiority or Other|||||||0.67|||||||ANOVA||||
1724773|NCT00630734|3176121|Superiority or Other|||||||0.22|||||||ANOVA||||
1724774|NCT00630734|3176122|Superiority or Other|||||||0.15|||||||ANOVA||||
1724775|NCT00630734|3176123|Superiority or Other|||||||0.11|||||||ANOVA||||
1724776|NCT00630734|3176124|Superiority or Other|||||||0.85|||||||ANOVA||||
1724777|NCT00630734|3176125|Superiority or Other|||||||0.66|||||||ANOVA||||
1724778|NCT00630734|3176126|Superiority or Other|||||||0.28|||||||ANOVA||||
1724779|NCT00630734|3176127|Superiority or Other|||||||0.43||||||Threshold of significance was P<0.05.|ANOVA|||Relative change data were compared between SLCO1B1 diplotype groups using one-way ANOVA (with post-hoc Bonferroni tests).|
1724780|NCT00630331|3176174|Superiority or Other||Vaccine Efficacy|53.2||||0.26|1-Sided|97.5|22.2|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724781|NCT00630331|3176174|Superiority or Other||Vaccine Efficacy|49.3||||0.53|1-Sided|97.5|0.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724782|NCT00630331|3176174|Superiority or Other||Vaccine Efficacy|81.5|||<|0.001|1-Sided|97.5|60.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724783|NCT00630331|3176174|Superiority or Other||Vaccine Efficacy|63.0|||<|0.003|1-Sided|97.5|46.7|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724868|NCT00626821|3176470|Superiority or Other||Mean Difference (Net)|1.813|Standard Error of the Mean|0.133|<|0.0001|2-Sided|95.0|1.553|2.073|||Mixed Models Analysis||||
1726694|NCT00594022|3181139|Superiority or Other|||||||0.1275|||||||t-test, 1 sided||||
1724784|NCT00630331|3176174|Superiority or Other||Vaccine Efficacy|49.9|||<|0.37|1-Sided|97.5|18.2|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724785|NCT00630331|3176174|Superiority or Other||Vaccine Efficacy|75.6|||<|0.04|1-Sided|97.5|35.1|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724786|NCT00630331|3176174|Superiority or Other||Vaccine Efficacy|89.3|||<|0.001|1-Sided|97.5|73.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724787|NCT00630331|3176174|Superiority or Other||Vaccine Efficacy|69.5|||<|0.001|1-Sided|97.5|55.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724788|NCT00630331|3176175|Superiority or Other||Vaccine Efficacy|51.7||||0.319|1-Sided|97.5|19.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724789|NCT00630331|3176175|Superiority or Other||Vaccine Efficacy|73.6||||0.265|1-Sided|97.5|-30.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724790|NCT00630331|3176175|Superiority or Other||Vaccine Efficacy|100.0||||0.033|1-Sided|97.5|33.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724791|NCT00630331|3176175|Superiority or Other||Vaccine Efficacy|58.6||||0.085|1-Sided|97.5|32.9|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724792|NCT00630331|3176175|Superiority or Other||Vaccine Efficacy|50.0||||0.376|1-Sided|97.5|17.5|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724793|NCT00630331|3176175|Superiority or Other||Vaccine Efficacy|100.0||||0.03|1-Sided|97.5|36.3|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724794|NCT00630331|3176175|Superiority or Other||Vaccine Efficacy|87.3||||0.104|1-Sided|97.5|4.6|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724795|NCT00630331|3176175|Superiority or Other||Vaccine Efficacy|58.7||||0.078|1-Sided|97.5|33.5|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724872|NCT00626522|3176520|Superiority or Other||Least squares mean difference|0.254|Standard Error of the Mean|0.038|<|0.0001|2-Sided|95.0|0.18|0.329|||ANCOVA||||
1724796|NCT00630331|3176176|Superiority or Other||Vaccine Efficacy|100.0||||0.4|1-Sided|97.5|0.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724797|NCT00630331|3176176|Superiority or Other|||||||0.992||||||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|For strain A/H3N2, the vaccine efficacy of the IVV vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.||Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.|
1724798|NCT00630331|3176176|Superiority or Other||Vaccine Efficacy|80.3||||0.002|1-Sided|97.5|54.7|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724799|NCT00630331|3176176|Superiority or Other||Vaccine Efficacy|78.4||||0.004|1-Sided|97.5|52.1|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of IVV vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of IVV vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724800|NCT00630331|3176176|Superiority or Other||Vaccine Efficacy|100.0||||0.394|1-Sided|97.5|0.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for B strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724801|NCT00630331|3176176|Superiority or Other|||||||0.999||||||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|For strain A/H3N2, the vaccine efficacy of the CCI vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.||Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H3N2 strain. Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.|
1724802|NCT00630331|3176176|Superiority or Other||Vaccine Efficacy|88.2|||<|0.001|1-Sided|97.5|67.4|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo for A/H1N1 strain~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724803|NCT00630331|3176176|Superiority or Other||Vaccine Efficacy|83.8|||<|0.001|1-Sided|97.5|61.0|||Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.|Sidak-corrected score CI|||"Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall)~Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks."|
1724804|NCT00629018|3176244|Superiority or Other|||||||0.01|||||||Log Rank|||The minimal sample size for the study was calculated using a pre-specified power of 90% and P value of 0.05.|
1724805|NCT00628589|3176278|Superiority||||||<|0.0001|||||||Fisher Exact||||
1724806|NCT00628589|3176278|Superiority||||||<|0.0015|||||||Fisher Exact||||
1724807|NCT00628589|3176279|Superiority||||||<|0.0001|||||||Fisher Exact||||
1724808|NCT00628589|3176279|Superiority||||||<|0.0015|||||||Fisher Exact||||
1724809|NCT00628589|3176280|Superiority||||||<|0.0001|||||||ANCOVA|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|||
1724810|NCT00628589|3176280|Superiority|LS mean was used in the primary efficacy analysis|||||<|0.0004|||||||ANCOVA|p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|||
1724811|NCT00628251|3176291|Superiority or Other (legacy)||Hazard Ratio (HR)|1.01||||0.9877|2-Sided|95.0|0.44|2.27||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of <1 favoured olaparib.|Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).|
1724812|NCT00628251|3176291|Superiority or Other (legacy)||Hazard Ratio (HR)|0.66||||0.3417|2-Sided|95.0|0.27|1.55||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of <1 favoured olaparib.|Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).|
1724813|NCT00628251|3176291|Superiority or Other (legacy)||Hazard Ratio (HR)|0.82||||0.5781|2-Sided|95.0|0.41|1.7||2-sided p-value|Regression, Cox|Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.|A hazard ratio of <1 favoured olaparib.|Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).|
1724869|NCT00626795|3176491|Non-Inferiority|The lower confidence limit greater or equal to -12.5% indicates non-inferiority.|Difference in percentage|-3.35|||||2-Sided|95.0|-10.28|3.57|||||Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).||
1724814|NCT00628251|3176297|Superiority or Other (legacy)||Odds Ratio (OR)|2.69||||0.1079|2-Sided|95.0|0.81|9.76|||Regression, Logistic|The analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio >1 favoured olaparib|Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).|
1724815|NCT00628251|3176297|Superiority or Other (legacy)||Odds Ratio (OR)|1.9||||0.3131|2-Sided|95.0|0.55|7.01||2-sided p-value|Regression, Logistic|Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio >1 favoured olaparib.|Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).|
1724816|NCT00628251|3176297|Superiority or Other (legacy)||Odds Ratio (OR)|2.27||||0.1291|2-Sided|95.0|0.79|7.32||2-sided p-value|Regression, Logistic|Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.|An odds ratio >1 favoured olaparib|Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).|
1724817|NCT00628251|3176298|Superiority or Other (legacy)||Hazard Ratio (HR)|0.86||||0.6604|2-Sided|95.0|0.45|1.62||An observed p-value of <0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio < 1 favours olaparib.|
1724818|NCT00628251|3176298|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.7794||95.0|0.48|1.74||An observed p-value of <0.005 (1-sided) will be regarded as statistically significant for a given pairwise comparison.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33). A hazard ratio < 1 favours olaparib.|
1724819|NCT00628251|3176298|Superiority or Other (legacy)||Hazard Ratio (HR)|0.88||||0.6604|2-Sided|95.0|0.51|1.56||If the observed p-value for the combined olaparib groups is <0.02 (1-sided) then the result will be regarded as statistically significant.|Regression, Cox|Cox proportional hazards model with factors for treatment, BRCA (1 or 2) and platinum sensitivity (sensitive=1 or resistant/refractory=0).||Analysis of olaparib 200 or 400 mg bd (n=64) versus liposomal doxorubicin (n=33). A hazard ratio < 1 favours olaparib.|
1724820|NCT00628134|3176307|Superiority or Other|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pairs signed-ranks test was used for comparisons|
1724821|NCT00628134|3176308|Superiority or Other|||||||0.07|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon matched-pairs signed-ranks test was used for comparisons|
1724822|NCT00628030|3176322|Superiority or Other|||||||0.024|||||||Chi-squared||||
1724823|NCT00628030|3176323|Superiority or Other|||||||0.13|||||||Chi-squared||||
1724824|NCT00628030|3176324|Superiority or Other|||||||0.61|||||||Chi-squared||||
1724825|NCT00628030|3176325|Superiority or Other|||||||0.041|||||||Chi-squared||||
1724826|NCT00628030|3176326|Superiority or Other|||||||0.008|||||||Chi-squared||||
1724827|NCT00627926|3176329|Superiority or Other||Difference in percentage|32.5|||||2-Sided|95.0|25.9|39.2||||||SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.|
1724828|NCT00627926|3176329|Superiority or Other||Difference in percentage|25.7|||||2-Sided|95.0|18.8|32.6||||||SVR FDA Guidance: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment. Analysis was based only on the HCV RNA assessment in visit window (+/-2 weeks); if there were more than 1 assessment in the window, the last measurement was used.|
1724829|NCT00627926|3176329|Superiority or Other||Difference in percentage|30.9|||||2-Sided|95.0|24.1|37.7||||||SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).|
1724830|NCT00627926|3176329|Superiority or Other||Difference in percentage|24.9|||||2-Sided|95.0|17.9|31.9||||||SVR Protocol Defined: undetectable HCV RNA at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA between end of treatment visit (up to Week 48) and 24 weeks after last planned dose (up to Week 72).|
1724831|NCT00627926|3176334|Superiority or Other||Difference in percentage|31.7|||||2-Sided|95.0|24.9|38.5|||||||
1724832|NCT00627926|3176334|Superiority or Other||Difference in percentage|25.2|||||2-Sided|95.0|18.2|32.2|||||||
1724833|NCT00627926|3176335|Superiority or Other||Difference in percentage|31.2|||||2-Sided|95.0|24.4|37.9|||||||
1724834|NCT00627926|3176335|Superiority or Other||Difference in percentage|25.5|||||2-Sided|95.0|18.5|32.4|||||||
1724835|NCT00627926|3176336|Superiority or Other||Difference in percentage|23.1|||||2-Sided|95.0|17.0|29.2|||||||
1724836|NCT00627926|3176336|Superiority or Other||Difference in percentage|17.6|||||2-Sided|95.0|11.2|24.0|||||||
1724837|NCT00627926|3176337|Superiority or Other||Difference in percentage|37.5|||||2-Sided|95.0|30.9|44.1|||||||
1724838|NCT00627926|3176337|Superiority or Other||Difference in percentage|35.7|||||2-Sided|95.0|29.0|42.4|||||||
1724839|NCT00627926|3176338|Superiority or Other||Difference in percentage|50.4|||||2-Sided|95.0|44.6|56.2|||||||
1724840|NCT00627926|3176338|Superiority or Other||Difference in percentage|48.8|||||2-Sided|95.0|43.0|54.6|||||||
1724841|NCT00627926|3176339|Superiority or Other||Difference in percentage|58.4|||||2-Sided|95.0|52.7|64.0|||||||
1724842|NCT00627926|3176339|Superiority or Other||Difference in percentage|57.1|||||2-Sided|95.0|51.4|62.8|||||||
1724843|NCT00627926|3176340|Superiority or Other||Difference in percentage|29.2|||||2-Sided|95.0|22.4|36.1|||||||
1724844|NCT00627926|3176340|Superiority or Other||Difference in percentage|23.0|||||2-Sided|95.0|15.9|30.0|||||||
1724845|NCT00627705|3176346|Superiority or Other|||||||0.141|||||||mixed effects regression models|degrees of freedom were 1, 22||F-values were derived from the interaction of Participant Group (NAC vs. Placebo) and Time (Week) in mixed effects regression models.|
1724870|NCT00626795|3176491|Non-Inferiority|The lower confidence limit greater or equal to -12.5% indicates non-inferiority.|Difference in percentage|4.56|||||2-Sided|95.0|-1.59|10.71|||||Estimated using a Cochran-Mantel-Haenszel approach, stratifying by country and disease (impetigo/SITL).||
1724846|NCT00627705|3176348|Superiority or Other||||||<|0.001||||||Aberrant Behavior Checklist irritability subscale (F = 6.80; p = <.001; d = .96).|Mixed effects regression models|||F values were derived from the interaction of participant group (NAC vs. placebo) and time (week) in mixed effects regression models. Cohen’s d was computed based on the standardized mean difference in the change from baseline to week 12.|
1724847|NCT00627705|3176350|Superiority or Other|||||||0.449|||||||mixed effects regression models|F= 0.81||Cohen's d = 0.30|
1724848|NCT00627523|3176361|Superiority or Other||Mean Difference (Final Values)|-4.51|Standard Error of the Mean|4.27||0.301|2-Sided|95.0|-13.27|4.26||ANCOVA model, fitting treatment as a factor, and the baseline parameter value, age, and gender as covariates were used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.|
1724849|NCT00627523|3176362|Superiority or Other||Mean Difference (Final Values)|2.43|Standard Error of the Mean|7.19||0.738|2-Sided|95.0|-12.27|17.12||ANCOVA model, fitting treatment as a factor, and the baseline parameter value, age, and gender as covariates were used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.|
1724850|NCT00627523|3176363|Superiority or Other||Mean Difference (Final Values)|3.24|Standard Error of the Mean|0.8|<|0.001|2-Sided|95.0|1.63|4.85||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.|
1724851|NCT00627523|3176364|Superiority or Other||Mean Difference (Final Values)|0.89|Standard Error of the Mean|0.17|<|0.001|2-Sided|95.0|0.55|1.23||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.|
1724852|NCT00627523|3176365|Superiority or Other||Mean Difference (Final Values)|0.77|Standard Error of the Mean|0.81||0.348|2-Sided|95.0|-0.87|2.42||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference between the Genotropin® and the untreated control group in terms of the relevant secondary endpoints. The alternative hypothesis was that a difference existed.|
1724853|NCT00627523|3176366|Superiority or Other||Mean Difference (Final Values)|1.2|Standard Error of the Mean|0.19|<|0.001|2-Sided|95.0|0.82|1.59||ANCOVA model, fitting treatment as a factor, and the baseline parameter value as covariate was used. All hypotheses were tested at a 5% level of significance.|ANCOVA|No adjustments were made for multiple comparisons.||The null hypothesis was that there was no difference in the mean change from Baseline after 24 months in height SDS between the Genotropin® and the untreated control groups. The alternative hypothesis was that there was a difference between the treatment groups.|
1724854|NCT00627393|3176431|Superiority or Other||Hazard Ratio (HR)|1.293|Standard Error of the Mean|0.25885||0.35|2-Sided|95.0|0.778|2.147|||Log Rank|Log-rank test to compare survival distributions between the control group and treatment group.|The control group is considered the reference group.||
1724855|NCT00627393|3176436|Superiority or Other||Log Rank P-Value|0.43||||0.43|2-Sided|||||Competing risks analysis for time to GVHD for subjects with allogeneic HST. The sample size was very small (n=7 in the granulocyte group, and n=8 in the control group).|Competing Risks||||
1724856|NCT00627393|3176439|Superiority or Other||Odds Ratio (OR)|1.19||||0.73|2-Sided|95.0|0.44|3.2|||Regression, Logistic|Ordinary multiple logistic regression including treatment arm, infection strata, underlying disease, zubrod score, respiratory symptoms, and age.|Control group is the reference group. Model adjusted for infection strata, underlying disease, zubrod score, respiratory symptoms, and age.||
1724857|NCT00627094|3176447|Superiority or Other||Odds Ratio (OR)|1.73||||0.0438|2-Sided|95.0|1.02|2.96||In order to obtain 90% power to show superiority of Biatain Ibu compared to Biatain, a sample size of 60 pts per group (assuming a 15% drop-out rate) was found by simulating data from multi-nomial distributions over time.|Chi-squared|Result based on ITT population (evening). PP-analysis show a strong tendency (not significant) in favour of Biatain Ibu supporting the ITT-analysis||The null hypothesis to be tested was that the distributions of categorical responses were the same.|
1724858|NCT00627016|3176455|Superiority or Other||||||<|0.001||||||Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.|Fisher Exact||||
1724859|NCT00627016|3176456|Superiority or Other||||||<|0.001||||||Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.|Fisher Exact||||
1724860|NCT00627016|3176457|Superiority or Other||||||<|0.001||||||Statistical significance for the comparison of the primary endpoint was determined at 0.05 level.|Wilcoxon (Mann-Whitney)||||
1724861|NCT00626925|3176458|Superiority or Other|||||||0.01|||||||Mixed Models Analysis||||
1724862|NCT00626925|3176459|Superiority or Other|||||||0.06|||||||Mixed Models Analysis||||
1724863|NCT00626925|3176460|Superiority or Other|||||||0.001|||||||Mixed Models Analysis||||
1724864|NCT00626925|3176461|Superiority or Other|||||||0.04|||||||Mixed Models Analysis||||
1724865|NCT00626925|3176462|Superiority or Other|||||||0.004|||||||Mixed Models Analysis||||
1724866|NCT00626925|3176464|Superiority or Other|||||||0.01|||||||Mixed Models Analysis||||
1724867|NCT00626925|3176465|Superiority or Other|||||||0.001|||||||Mixed Models Analysis||||
1724873|NCT00626522|3176520|Superiority or Other||Least squares mean difference|0.206|Standard Error of the Mean|0.038|<|0.0001|2-Sided|95.0|0.131|0.28|||ANCOVA||||
1724874|NCT00626392|3176540|Superiority or Other|||||||0.01||||||No adjustments were made for multiple comparisons. P-values <= 0.05 were reported as statistically significant.|Cochran-Mantel-Haenszel||||
1724875|NCT00626327|3176547|Non-Inferiority or Equivalence|The immune response of MMRV+MenACWY group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentages of subjects with seroconversion for varicella was greater than -10%.|Difference% (MenACWY-CRM+MMRV- MMRV)|-1.0|||||2-Sided|95.0|-2.4|0.8||||||Non-inferiority of anti-varicella response following one dose of MMRV when administered concomitantly with MenACWY vaccine as compared to MMRV administered alone.|
1724876|NCT00626327|3176552|Non-Inferiority or Equivalence|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|2.0|||||2-Sided|95.0|-1.9|5.3||||||Non-inferiority of immune response of MenACWY-CRM against serogroup Y when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.|
1724877|NCT00626327|3176552|Non-Inferiority or Equivalence|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|1.0|||||2-Sided|95.0|-1.3|3.9||||||Non-inferiority of immune response of MenACWY-CRM against serogroup W-135 when concomitantly administered with MMRV vaccine as compared to MenACWY vaccine given alone.|
1724878|NCT00626327|3176552|Non-Inferiority or Equivalence|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|0.0|||||2-Sided|95.0|-1.8|1.9||||||Non-inferiority of immune response of MenACWY-CRM against serogroup C when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.|
1724879|NCT00626327|3176552|Non-Inferiority or Equivalence|The immune response of MenACWY-CRM + MMRV group was considered non-inferior to that of MenACWY-CRM group if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12 month old toddlers was greater than -10% for each serogroup.|Difference% (MenACWY-CRM+MMRV-MenACWY)|0.0|||||2-Sided|95.0|-4.7|4.5||||||Non-inferiority of immune response of MenACWY-CRM against serogroup A when concomitantly administered with MMRV vaccine as compared to MenACWY-CRM vaccine given alone.|
1724880|NCT00626327|3176553|Non-Inferiority or Equivalence|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroprotection for varicella was greater than –10%, at 6 weeks after MMRV vaccination.|Difference% (MenACWY-CRM+MMRV-MMRV)|-1.0|||||2-Sided|95.0|-3.9|1.2||||||Non-inferiority of immune response to varicella following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.|
1724881|NCT00626327|3176553|Non-Inferiority or Equivalence|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for rubella was greater than -5%, at 6 weeks after MMRV vaccination.|Difference% (MenACWY-CRM+MMRV-MMRV)|-2.0|||||2-Sided|95.0|-4.5|0.8||||||Non-inferiority of immune response to rubella following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.|
1724882|NCT00626327|3176553|Non-Inferiority or Equivalence|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for mumps was greater than -5%, at 6 weeks after MMRV vaccination.|Difference % (MenACWY-CRM+MMRV - MMRV )|1.0|||||2-Sided|95.0|-1.0|3.7||||||Non-inferiority of immune response to mumps following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV administered alone.|
1724883|NCT00626327|3176553|Non-Inferiority or Equivalence|The immune response of MenACWY-CRM+MMRV group was considered non-inferior to that of MMRV group if the lower limit of the two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles was greater than -5%, at 6 weeks after MMRV vaccination.|Difference % (MenACWY-CRM+MMRV-MMRV)|-1.0|||||2-Sided|95.0|-3.4|0.5||||||Non-inferiority of immune response to measles following one dose of MMRV administered concomitantly with MenACWY-CRM as compared to MMRV given alone.|
1724884|NCT00625872|3176583|Superiority or Other||LS Mean difference|-0.27|Standard Error of the Mean|0.12||0.0458|2-Sided|95.0|-0.54|-0.01||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Suprailiac SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.|
1724885|NCT00625872|3176583|Superiority or Other||LS Mean difference|-0.15|Standard Error of the Mean|0.15||0.3494|2-Sided|95.0|-0.49|0.19||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Subscapular SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.|
1724886|NCT00625872|3176583|Superiority or Other||LS Mean difference|-0.35|Standard Error of the Mean|0.25||0.187|2-Sided|95.0|-0.89|0.2||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Triceps SDS: ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.|
1724887|NCT00625872|3176592|Superiority or Other||LS Mean difference|4.67|Standard Error of the Mean|1.54||0.0161|2-Sided|95.0|1.13|8.21||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.|
1724888|NCT00625872|3176594|Superiority or Other||LS Mean difference|0.55|Standard Error of the Mean|0.31||0.1107|2-Sided|95.0|-0.15|1.25||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.|
1724889|NCT00625872|3176610|Superiority or Other||LS Mean difference|0.14|Standard Error of the Mean|2.54||0.956|2-Sided|95.0|-5.71|6.0||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.|
1724890|NCT00625872|3176629|Superiority or Other|||||||0.3291||||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Vigilance): Kruskal-Wallis ANOVA model was used to calculate p-value.|
1724891|NCT00625872|3176629|Superiority or Other|||||||0.1234||||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Go/No Go): Kruskal-Wallis ANOVA model was used to calculate p-value.|
1724892|NCT00625872|3176629|Superiority or Other|||||||1||||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Flexibility): Kruskal-Wallis ANOVA model was used to calculate p-value.|
1724893|NCT00625872|3176629|Superiority or Other|||||||0.859||||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Alertness): Kruskal-Wallis ANOVA model was used to calculate p-value.|
1724894|NCT00625872|3176629|Superiority or Other|||||||0.6256||||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For KITAP Test (Distractibility): Kruskal-Wallis ANOVA model was used to calculate p-value.|
1724895|NCT00625872|3176631|Superiority or Other|||||||0.3458||||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Mental Processing Composite): Kruskal-Wallis ANOVA model was used to calculate p-value.|
1724896|NCT00625872|3176631|Superiority or Other|||||||0.4935||||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Non-Verbal): Kruskal-Wallis ANOVA model was used to calculate p-value.|
1724897|NCT00625872|3176631|Superiority or Other|||||||0.683||||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Achievement): Kruskal-Wallis ANOVA model was used to calculate p-value.|
1724898|NCT00625872|3176631|Superiority or Other|||||||0.3383||||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Simultaneous Processing): Kruskal-Wallis ANOVA model was used to calculate p-value.|
1724899|NCT00625872|3176631|Superiority or Other|||||||0.0532||||||The statistical test was 2-sided and performed at the 5 percent significance level.|Kruskal-Wallis|||For K-ABC Test (Sequential Processing): Kruskal-Wallis Analysis of Variance (ANOVA) model was used to calculate p-value.|
1724900|NCT00625872|3176633|Superiority or Other||LS Mean difference|-1.61|Standard Error of the Mean|0.51||0.1941|2-Sided|95.0|-8.04|4.82||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||ANCOVA method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.|
1724901|NCT00625872|3176634|Superiority or Other||Least squares (LS) mean difference|-0.43|Standard Error of the Mean|1.1||0.7232|2-Sided|95.0|-3.93|3.08||The statistical test was 2-sided and performed at the 5 percent significance level.|ANCOVA|||Analysis of covariance (ANCOVA) method was used to calculate p-value with treatment, baseline value, study duration and site as covariates.|
1724902|NCT00625807|3176649|Other||||||<|0.001|||||||t-test, 2 sided|||within group change from pre to post|
1724903|NCT00625807|3176649|Other||||||<|0.06|||||||t-test, 2 sided|||within group change from pre to week 8|
1724904|NCT00625807|3176650|Other|||||||0.53|||||||t-test, 2 sided|||within group change from pre to week 8|
1724905|NCT00625807|3176650|Other|||||||0.015|||||||t-test, 2 sided|||within group change from pre to week 8|
1724906|NCT00625807|3176651|Other|within group change from pre to week 8|||||<|0.001|||||||t-test, 2 sided||||
1724907|NCT00625807|3176651|Other||||||<|0.022|||||||t-test, 2 sided|||within group change pre to week 8|
1724908|NCT00625807|3176652|Other|||||||0.103|||||||ANOVA||||
1724909|NCT00625807|3176653|Other||||||>|0.1||||||Cohen's d = 0.5|ANOVA|||ANOVA for group by time interaction|
1724910|NCT00625404|3176682|Superiority or Other||Mean Difference (Final Values)|0.01||||0.73|||||||t-test, 2 sided|||t-test for difference in change in number of sexual partners over time|
1724911|NCT00625404|3176686|Superiority or Other||Mean Difference (Final Values)|22.1||||0.82|||||||t-test, 2 sided|||t-test for difference in mean CD-4 counts|
1724912|NCT00625404|3176687|Superiority or Other||Mean Difference (Final Values)|0.03||||0.89|||||||t-test, 2 sided|||t-test for difference on viral loads|
1724913|NCT00625404|3176688|Superiority or Other|||||||0.62|||||||Log Rank|||Log-rank test for difference in rates between groups|
1724914|NCT00625404|3176689|Superiority or Other|||||||0.79|||||||Log Rank|||Log-rank test for difference in rates between groups|
1724915|NCT00625404|3176690|Superiority or Other|||||||0.59|||||||Log Rank|||Log-rank test for difference in rates between groups|
1724916|NCT00625404|3176692|Superiority or Other|||||||0.45|||||||Log Rank|||Log-rank test for difference in rate of grade 2 or higher creatinine, based on time to first event.|
1724917|NCT00625404|3176693|Superiority or Other||Hazard Ratio (HR)|0.94|||||2-Sided|95.0|0.59|1.52||||||Hazard ratio (HR) for HIV infection based on proportional hazards model, stratified on site. Study was designed to have 90% power to reject the null hypothesis that the HR for infection is > 0.3|
1724918|NCT00624520|3176812|Superiority or Other||Mean Difference (Final Values)|80.0||||0.81|2-Sided|||||Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post|ANOVA|||"Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate."|
1724919|NCT00624520|3176813|Superiority or Other||Effect size (Cohen's d)|0.38||||0.025|2-Sided|||||P-value refers to a repeated measures within-group comparison in the CBSM group using ANCOVA with baseline DP elevation as covariate from baseline to 3 months post.|ANCOVA||Range of Cohen's d for small effect is 0.20 - 0.50||
1724920|NCT00624520|3176814|Superiority or Other|||||||0.21|||||||Fisher Exact||||
1724921|NCT00624520|3176815|Superiority or Other||Mean Difference (Final Values)|-2.02||||0.01|2-Sided||||||ANOVA||||
1724925|NCT00624520|3176819|Superiority or Other||Mean Difference (Final Values)|-4.0||||0.011|2-Sided||||||ANOVA||||
1724926|NCT00624520|3176820|Superiority or Other||Mean Difference (Final Values)|-4.0||||0.003|2-Sided||||||ANOVA||||
1724927|NCT00624520|3176821|Superiority or Other||Mean Difference (Final Values)|3.0||||0.02|2-Sided||||||ANOVA||||
1724928|NCT00624520|3176822|Superiority or Other||Mean Difference (Final Values)|891.0||||0.18|2-Sided|||||Statistical Analysis presented for comparison groups Cognitive Behavioral Stress Management vs. Patient Education at 6 months post|ANOVA|||"Initial sample size calculation, based on previous published data of effects sizes of anger stress management on heart rate and blood pressure responses in a veteran population, indicated a study population of 138 patients should detect a reduction in Double Product response to mental stress following psychological intervention, with over 90% power, assuming 20% drop-out rate."|
1724929|NCT00624442|3176834|Superiority or Other||||||<|0.0001||||||Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect||"All available concentration data are used in the model as a continuous variable.~p-value based on individual plasma concentration of CK-1827452 vs. corresponding fractional shortening PD assessment (not binned based on plasma concentration)"|
1724930|NCT00624442|3176834|Superiority or Other||LSM placebo corrected diff from baseline|5.0|||<|0.0001|2-Sided|95.0|3.0|6.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean|
1724931|NCT00624442|3176834|Superiority or Other||LSM placebo corrected diff from baseline|2.0|||<|0.032|2-Sided|95.0|0.0|5.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean|
1724932|NCT00624442|3176834|Superiority or Other||LSM placebo corrected diff from baseline|3.0|||<|0.0086|2-Sided|95.0|1.0|4.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean|
1724933|NCT00624442|3176834|Superiority or Other||LSM placebo corrected diff from baseline|3.0|||<|0.0004|2-Sided|95.0|1.0|5.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean|
1724934|NCT00624442|3176834|Superiority or Other||LSM placebo corrected diff from baseline|1.0|||<|0.0357|2-Sided|95.0|0.0|3.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean|
1724935|NCT00624442|3176834|Superiority or Other||LSM placebo corrected diff from baseline|1.0|||<|0.3665|2-Sided|95.0|-1.0|2.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean|
1724936|NCT00624442|3176835|Superiority or Other||||||<|0.0001||||||Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis based on the following model: Change from baseline = Concentration + Baseline + Error, treating patients as random effect||"All available concentration data are used in the model as a continuous variable.~p-value based on individual plasma concentration of CK-1827452 vs. corresponding systolic ejection time PD assessment (not binned based on plasma concentration)"|
1724937|NCT00624442|3176835|Superiority or Other||LSM placebo corrected diff from baseline|80.0|||<|0.0001|2-Sided|95.0|71.0|89.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean|
1724938|NCT00624442|3176835|Superiority or Other||LSM placebo corrected diff from baseline|59.0|||<|0.0001|2-Sided|95.0|47.0|72.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean|
1724939|NCT00624442|3176835|Superiority or Other||LSM placebo corrected diff from baseline|58.0|||<|0.0001|2-Sided|95.0|46.0|70.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean|
1724940|NCT00624442|3176835|Superiority or Other||LSM placebo corrected diff from baseline|47.0|||<|0.0001||95.0|38.0|56.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean|
1724941|NCT00624442|3176835|Superiority or Other||LSM placebo corrected diff from baseline|18.0|||<|0.0001|2-Sided|95.0|10.0|27.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean|
1724969|NCT00623623|3176942|Other||Relative Risk|8.02||||0.049|2-Sided|95.0|1.0|63.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724942|NCT00624442|3176835|Superiority or Other||LSM placebo corrected diff from baseline|1.0|||<|0.8842|2-Sided|95.0|-7.0|8.0||p-value is not adjusted for multiple comparison Threshold for statistical significance: p<0.05|ANCOVA|ANCOVA analysis is based on the following model: CFB Parameter = Bin Group + Baseline + Error, treating patients as a random effect.||Placebo corrected change from baseline least squares mean +/- the standard error of the mean|
1724943|NCT00624338|3176849|Superiority or Other||Odds Ratio (OR)|0.722||||0.198|2-Sided|95.0|0.44|1.19||Odds ratios were calculated from a logistic regression model, adjusted for race and disease severity reported at screening.|Regression, Logistic|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.|||
1724944|NCT00624338|3176849|Superiority or Other||Odds Ratio (OR)|1.215||||0.412|2-Sided|95.0|0.76|1.94||Odds ratios were calculated from a logistic regression model, adjusted for race and disease severity reported at screening.|Regression, Logistic||||
1724945|NCT00624338|3176850|Superiority or Other||Hazard Ratio (HR)|0.562||||0.009|2-Sided|95.0|0.36|0.87||Cox proportional hazards model was performed to calculate hazard ratios and adjusted for race and disease severity at time of screening.|Regression, Cox|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.|||
1724946|NCT00624338|3176850|Superiority or Other||Hazard Ratio (HR)|0.984||||0.929|2-Sided|95.0|0.69|1.4||Cox proportional hazards model was performed to calculate hazard ratios and adjusted for race and disease severity at time of screening.|Regression, Cox||||
1724947|NCT00624338|3176851|Superiority or Other||Odds Ratio (OR)|0.49||||0.003|2-Sided|95.0|0.31|0.78||Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at screening.|Regression, Logistic|Atacicept 150 mg arm was discontinued prematurely. The analysis of 150 mg was considered post-hoc.|||
1724948|NCT00624338|3176851|Superiority or Other||Odds Ratio (OR)|1.16||||0.518|2-Sided|95.0|0.74|1.82||Odds ratios were calculated from a logistic regression model adjusted for race and disease severity reported at screening.|Regression, Logistic||||
1724949|NCT00624221|3176858|Non-Inferiority or Equivalence|The sample size of 40 subjects was estimated based on having 80% power to determine greater than 10% difference in cell loss between groups with estimated standard deviation of 17 and estimated correlation of 0.5.||||||0.1|||||||paired difference t-test||||
1724950|NCT00624065|3176861|Superiority or Other||Odds Ratio (OR)|0.968||||0.8822||95.0|0.63|1.49|||Regression, Logistic||||
1724951|NCT00624052|3176875|Superiority or Other||Odds Ratio (OR)|0.84||||||95.0|0.42|1.68|||||||
1724952|NCT00624052|3176875|Superiority or Other||Odds Ratio (OR)|0.27||||||95.0|0.15|0.49|||||||
1724953|NCT00624052|3176875|Superiority or Other||Odds Ratio (OR)|0.32||||||95.0|0.17|0.59|||||||
1724954|NCT00624052|3176875|Superiority or Other||Odds Ratio (OR)|0.24||||||95.0|0.12|0.48|||||||
1724955|NCT00624052|3176875|Superiority or Other||Odds Ratio (OR)|0.28||||||95.0|0.14|0.59|||||||
1724956|NCT00624052|3176875|Superiority or Other||Odds Ratio (OR)|0.88||||||95.0|0.47|1.66|||||||
1724957|NCT00623714|3176922|Superiority or Other||Geometric Mean Fold Difference|0.4||||0.002|2-Sided|95.0|0.26|0.63||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.|||
1724958|NCT00623714|3176923|Superiority or Other||Geometric Mean Fold Difference|0.34||||0.011|2-Sided|90.0|0.16|0.7||1-sided, alpha = 0.05|ANOVA|Analysis performed on log-transformed fold change from baseline and results were back-transformed for reporting.|||
1724959|NCT00623623|3176932|Other||Relative Risk|0.87||||0.22|2-Sided|95.0|0.69|1.09|||modified Poisson regression model|modified Poisson regression model with robust error variance|||
1724960|NCT00623623|3176933|Other||Relative risk|1.17||||0.451|2-Sided|95.0|0.78|1.73|||modified Poisson regression model|modified Poisson regression model with robust error variance|||
1724961|NCT00623623|3176934|Superiority||Relative Risk|0.35||||0.003|2-Sided|95.0|0.17|0.71|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724962|NCT00623623|3176935|Other||Relative Risk|0.84||||0.471|2-Sided|95.0|0.53|1.34|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724963|NCT00623623|3176936|Other||Relative Risk|1.13||||0.107|2-Sided|95.0|0.97|1.31|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724964|NCT00623623|3176937|Other||Relative Risk|1.08||||0.397|2-Sided|95.0|0.91|1.28|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724965|NCT00623623|3176938|Other||Relative Risk|1.36||||0.111|2-Sided|95.0|0.93|1.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724966|NCT00623623|3176939|Other||Relative Risk|3.01||||0.032|2-Sided|95.0|1.1|8.24|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724967|NCT00623623|3176940|Other||Relative Risk|2.0||||0.324|2-Sided|95.0|0.5|7.99|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724968|NCT00623623|3176941|Other||Relative Risk|4.51||||0.054|2-Sided|95.0|0.98|20.82|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724970|NCT00623623|3176943|Other||Relative Risk|4.99||||0.168|2-Sided|95.0|0.51|49.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724971|NCT00623623|3176944|Other||Relative Risk|1.75||||0.369|2-Sided|95.0|0.52|5.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724972|NCT00623623|3176945|Other||Relative Risk|0.91||||0.511|2-Sided|95.0|0.67|1.22|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724973|NCT00623623|3176946|Other||Relative risk|0.81||||0.1|2-Sided|95.0|0.63|1.04|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724974|NCT00623623|3176947|Other||Relative risk|0.81||||0.207|2-Sided|95.0|0.58|1.13|||modified Poission Regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724975|NCT00623623|3176948|Other||Relative risk|0.5||||0.572|2-Sided|95.0|0.05|5.52|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724976|NCT00623623|3176949|Other||Relative risk|1.72||||0.148|2-Sided|95.0|0.82|3.6|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724977|NCT00623623|3176950|Other||Relative risk|1.1||||0.663|2-Sided|95.0|0.73|1.66|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724978|NCT00623623|3176951|Other||Relative risk|1.1||||0.758|2-Sided|95.0|0.61|1.97|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724979|NCT00623623|3176952|Other||Relative risk|0.79||||0.17|2-Sided|95.0|0.57|1.11|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724980|NCT00623623|3176953|Superiority or Other||Relative risk|0.73||||0.12|2-Sided|95.0|0.49|1.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724981|NCT00623623|3176954|Other||Relative risk|0.97||||0.905|2-Sided|95.0|0.6|1.58|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724982|NCT00623623|3176955|Other||Relative risk|1.03||||0.904|2-Sided|95.0|0.68|1.55|||modified Poisson regression|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724983|NCT00623623|3176956|Other||Relative risk|0.86||||0.195|2-Sided|95.0|0.68|1.08|||modified Poisson regression model|modified Poisson regression model with robust error variance||No confirmatory statistical hypothesis was pre-specified. All statistical tests were of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.|
1724984|NCT00623545|3176978|Superiority or Other||Mean Difference (Final Values)|0.0|||<|0.05|2-Sided||||||t-test, 2 sided||||
1724985|NCT00623545|3176978|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||The null hypothesis was that energy intake was unchanged between the period before treatment and at the end of treatment.|
1724986|NCT00623545|3176979|Superiority or Other||Mean Difference (Final Values)|0.0|||<|0.05|2-Sided||||||t-test, 2 sided||||
1724987|NCT00623545|3176979|Superiority or Other||Mean Difference (Net)|185.0|Standard Deviation|240.0|<|0.001|2-Sided|95.0||||The a prior threshold for statistical significance was p< 0.05|ANOVA||units are kcal/d|Previously published literature showed an average weight loss of 1.8 kg at 12 weeks of exenatide treatment. This was converted to differ- ence in TEE, estimating an average imbalance of 2 kg × 7800 kcal·kg–1 divided by 84 days or 185 kcal·day–1.We demonstrated an average reproducibility of the DLW method of 6% or 240 kcal·day–1. For a 5% probability of finding this difference with a power of 80%, we determined a need for 14 subjects to complete the study.|
1724988|NCT00623480|3176983|Superiority or Other||estimated diff (prohylaxis vs. OD)|13.15|||||2-Sided|95.0|5.23|21.08|||||||
1724989|NCT00623480|3176984|Superiority or Other||estimated diff (prohylaxis vs. OD)|-0.94||||0.0072|2-Sided|95.0|-1.61|-0.26|||Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency|||
1724990|NCT00623480|3176985|Superiority or Other||estimated diff (prohylaxis vs. OD)|-0.17||||0.6614|2-Sided|95.0|-0.92|0.59|||Based on cLDA model|Adjusted for presence/absence of target joint and prior 6 month bleeding frequency|||
1724991|NCT00623480|3176986|Superiority or Other||Ratio (On-Demand vs. Prophylaxis)|14.7|||<|0.0001|2-Sided|95.0|8.1|26.5|||Negative Binomial Regression Model|Adjusted for time of follow-up|||
1724992|NCT00623467|3176987|Superiority or Other||Mean Difference (Final Values)|0.84|Standard Deviation|0.81|<|0.0001|||||||paired t-test||||
1724993|NCT00623467|3176988|Superiority or Other||Mean Difference (Final Values)|0.44|Standard Deviation|0.7|<|0.0001|||||||paired t-test||||
1724994|NCT00623467|3176989|Superiority or Other||Risk Difference (RD)|2.5||||0.0253|||||||McNemar||||
1724995|NCT00623467|3176990|Superiority or Other||Risk Difference (RD)|7.9||||0.0253|||||||McNemar||||
1724996|NCT00623467|3176991|Superiority or Other||Risk Difference (RD)|3.8||||0.0016|||||||McNemar||||
1724997|NCT00623467|3176992|Superiority or Other||Risk Difference (RD)|0.0||||1|||||||McNemar||||
1724998|NCT00623467|3176993|Superiority or Other||Risk Difference (RD)|20.6||||0.0003|||||||McNemar||||
1724999|NCT00623467|3176994|Superiority or Other||Risk Difference (RD)|5.0||||0.0093|||||||McNemar||||
1725000|NCT00623467|3176995|Superiority or Other||Risk Difference (RD)|-12.5||||0.0588|||||||McNemar||||
1725001|NCT00623467|3176996|Superiority or Other||Risk Difference (RD)|8.5||||0.0004|||||||McNemar||||
1725002|NCT00623467|3176997|Superiority or Other||Risk Difference (RD)|5.0||||0.0285|||||||McNemar||||
1725003|NCT00623467|3176998|Superiority or Other||Risk Difference (RD)|7.3||||0.0001|||||||McNemar||||
1725004|NCT00623467|3176999|Superiority or Other||Risk Difference (RD)|9.4||||0.0002|||||||McNemar||||
1725005|NCT00623467|3177000|Superiority or Other||Mean Difference (Final Values)|0.85|Standard Deviation|0.64|<|0.0001||||||for internal morphology|paired t test||||
1725006|NCT00623467|3177000|Superiority or Other||Mean Difference (Final Values)|0.99|Standard Deviation|0.63|<|0.0001||||||for border delineation|paired t-test||||
1725007|NCT00623467|3177001|Superiority or Other||Mean Difference (Final Values)|0.66|Standard Deviation|0.9|<|0.0001||||||for internal morphology|paired t test||||
1725008|NCT00623467|3177001|Superiority or Other||Mean Difference (Final Values)|0.82|Standard Deviation|1.0|<|0.0001||||||for border delineation|paired t-test||||
1725009|NCT00623467|3177003|Superiority or Other||Mean Difference (Final Values)|0.84|Standard Deviation|0.22|<|0.0001||||||for internal morphology|paired t test||||
1725010|NCT00623467|3177003|Superiority or Other||Mean Difference (Final Values)|1.09|Standard Deviation|0.3|<|0.0001||||||for border delineation|paired t test||||
1725011|NCT00623467|3177003|Superiority or Other||Mean Difference (Final Values)|2.32|Standard Deviation|0.34|<|0.0001||||||for contrast enhancement|paired t-test||||
1725012|NCT00623467|3177004|Superiority or Other||Mean Difference (Final Values)|0.72|Standard Deviation|0.3|<|0.0001||||||for internal morphology|paired t test||||
1725013|NCT00623467|3177004|Superiority or Other||Mean Difference (Final Values)|1.07|Standard Deviation|0.45|<|0.0001||||||for border delineation|paired t test||||
1725014|NCT00623467|3177004|Superiority or Other||Mean Difference (Final Values)|2.21|Standard Deviation|0.37|<|0.0001||||||for contrast enhancement|paired t-test||||
1725015|NCT00623467|3177005|Superiority or Other||Mean Difference (Final Values)|1.17|Standard Deviation|0.34|<|0.0001||||||for internal morphology|paired t test||||
1725016|NCT00623467|3177005|Superiority or Other||Mean Difference (Final Values)|1.27|Standard Deviation|0.38|<|0.0001||||||for border delineation|paired t test||||
1725017|NCT00623467|3177005|Superiority or Other||Mean Difference (Final Values)|2.35|Standard Deviation|0.4|<|0.0001||||||for contrast enhancement|paired t-test||||
1725018|NCT00623467|3177006|Superiority or Other||Mean Difference (Final Values)|0.62|Standard Deviation|0.32|<|0.0001||||||for internal morphology|paired t test||||
1725019|NCT00623467|3177006|Superiority or Other||Mean Difference (Final Values)|0.93|Standard Deviation|0.46|<|0.0001||||||for border delineation|paired t test||||
1725020|NCT00623467|3177006|Superiority or Other||Mean Difference (Final Values)|2.4|Standard Deviation|0.48|<|0.0001||||||for contrast enhancement|paired t-test||||
1725021|NCT00623467|3177007|Superiority or Other||Mean Difference (Final Values)|0.77|Standard Deviation|0.99|<|0.0001||||||for internal morphology|paired t test||||
1725022|NCT00623467|3177007|Superiority or Other||Mean Difference (Final Values)|1.0|Standard Deviation|1.27|<|0.0001||||||for border delineation|paired t test||||
1725023|NCT00623467|3177007|Superiority or Other||Mean Difference (Final Values)|1.51|Standard Deviation|1.32|<|0.0001||||||for contrast enhancement|paired t-test||||
1725024|NCT00623467|3177008|Superiority or Other||Mean Difference (Final Values)|0.91|Standard Deviation|1.02|<|0.0001||||||for internal morphology|paired t test||||
1725025|NCT00623467|3177008|Superiority or Other||Mean Difference (Final Values)|1.26|Standard Deviation|1.3|<|0.0001||||||for border delineation|paired t test||||
1725026|NCT00623467|3177008|Superiority or Other||Mean Difference (Final Values)|1.67|Standard Deviation|1.39|<|0.0001||||||for contrast enhancement|paired t-test||||
1725027|NCT00623467|3177009|Superiority or Other||Mean Difference (Final Values)|1.02|Standard Deviation|1.25|<|0.0001||||||for internal morphology|paired t test||||
1725028|NCT00623467|3177009|Superiority or Other||Mean Difference (Final Values)|1.12|Standard Deviation|1.6|<|0.0001||||||for border delineation|paired t test||||
1725029|NCT00623467|3177009|Superiority or Other||Mean Difference (Final Values)|1.49|Standard Deviation|1.38|<|0.0001||||||for contrast enhancement|paired t-test||||
1725030|NCT00623467|3177010|Superiority or Other||Mean Difference (Final Values)|0.45|Standard Deviation|1.03|<|0.0001||||||for internal morphology|paired t test||||
1725031|NCT00623467|3177010|Superiority or Other||Mean Difference (Final Values)|0.75|Standard Deviation|1.34|<|0.0001||||||for border delineation|paired t test||||
1725032|NCT00623467|3177010|Superiority or Other||Mean Difference (Final Values)|1.59|Standard Deviation|1.47|<|0.0001||||||for contrast enhancement|paired t-test||||
1725033|NCT00623467|3177011|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.21|Standard Deviation|1.6||||95.0|0.03|0.381|||||lower limit of the confidence interval is compared to the noninferiority margin||
1725034|NCT00623467|3177012|Superiority or Other||Mean Difference (Final Values)|0.74|Standard Deviation|0.65|<|0.0001||||||for internal morphology|paired t test||||
1725035|NCT00623467|3177012|Superiority or Other||Mean Difference (Final Values)|0.89|Standard Deviation|0.68|<|0.0001||||||for border delineation|paired t-test||||
1725108|NCT00621140|3177322|Superiority or Other||Mean Difference (Final Values)|-23.31|Standard Error of the Mean|3.59|<|0.0001||95.0|-30.37|-16.26|||ANCOVA|||Linagliptin vs. Placebo|
1725036|NCT00623467|3177013|Non-Inferiority or Equivalence|noninferiority margin = -0.35|Mean Difference (Final Values)|0.32|Standard Deviation|3.53|||2-Sided|95.0|-0.07|0.704|||||confidence interval provided for average reader, lower limit is compared to noninferiority margin||
1725037|NCT00623467|3177013|Superiority or Other||Mean Difference (Final Values)|0.45|Standard Deviation|4.2|||||||||||for BR3||
1725038|NCT00623467|3177013|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Deviation|8.77|||||||||||for BR2||
1725039|NCT00623467|3177013|Superiority or Other||Mean Difference (Final Values)|0.66|Standard Deviation|5.31|||||||||||for BR1||
1725040|NCT00623467|3177014|Superiority or Other||Mean Difference (Final Values)|0.78|Standard Deviation|0.53|<|0.0001||||||for internal morphology|paired t test||||
1725041|NCT00623467|3177014|Superiority or Other||Mean Difference (Final Values)|1.02|Standard Deviation|0.71|<|0.0001||||||for border delineation|paired t test||||
1725042|NCT00623467|3177014|Superiority or Other||Mean Difference (Final Values)|1.94|Standard Deviation|0.77|<|0.0001||||||for contrast enhancement|paired t-test||||
1725043|NCT00623467|3177015|Superiority or Other||Mean Difference (Final Values)|0.77|Standard Deviation|0.57|<|0.0001||||||for internal morphology|paired t test||||
1725044|NCT00623467|3177015|Superiority or Other||Mean Difference (Net)|1.12|Standard Deviation|0.74|<|0.0001||||||for border delineation|paired t test||||
1725045|NCT00623467|3177015|Superiority or Other||Mean Difference (Final Values)|1.93|Standard Deviation|0.82|<|0.0001||||||for contrast enhancement|paired t-test||||
1725046|NCT00623467|3177016|Superiority or Other||Mean Difference (Final Values)|1.08|Standard Deviation|0.74|<|0.0001||||||for internal morphology|paired t test||||
1725047|NCT00623467|3177016|Superiority or Other||Mean Difference (Final Values)|1.17|Standard Deviation|0.94|<|0.0001||||||for border delineation|paired t test||||
1725048|NCT00623467|3177016|Superiority or Other||Mean Difference (Final Values)|1.94|Standard Deviation|0.8|<|0.0001||||||for contrast enhancement|paired t-test||||
1725049|NCT00623467|3177017|Superiority or Other||Mean Difference (Final Values)|0.53|Standard Deviation|0.54|<|0.0001||||||for internal morphology|paired t test||||
1725050|NCT00623467|3177017|Superiority or Other||Mean Difference (Final Values)|0.85|Standard Deviation|0.74|<|0.0001||||||for border delineation|paired t test||||
1725051|NCT00623467|3177017|Superiority or Other||Mean Difference (Final Values)|2.03|Standard Deviation|0.86|<|0.0001||||||for contrast enhancement|paired t-test||||
1725052|NCT00623428|3177020|Superiority or Other||Odds Ratio (OR)|0.68||||0.1934|2-Sided|95.0|0.38|1.21|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.||
1725053|NCT00623428|3177021|Superiority or Other||Odds Ratio (OR)|0.68||||0.1934|2-Sided|95.0|0.38|1.21|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.||
1725054|NCT00623428|3177023|Superiority or Other||Odds Ratio (OR)|1.36||||0.5654|2-Sided|95.0|0.48|3.87|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.||
1725055|NCT00623428|3177024|Superiority or Other||Odds Ratio (OR)|0.59||||0.0788|2-Sided|95.0|0.33|1.06|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.||
1725056|NCT00623428|3177025|Superiority or Other||Odds Ratio (OR)|0.8||||0.4557|2-Sided|95.0|0.45|1.43|||Cochran-Mantel-Haenszel|Stratified by HCV genotype (2 vs 3), region (US vs non-US) and initial Ribavirin dose (800mg vs 1000-1200mg).|"The odds ratio is the ratio of the odds of a response in the 24-week treatment group to the odds of a response in the 48-week treatment group.~(second column)."|In order to detect an improvement in SVR rate across all strata equivalent to an odds ratio of 2 (i.e. an increase in SVR by 15 to 16 percentage points at a power of 80% and a two-sided significance level of 0.05, 160 patients per treatment group (320 patients in total) were required.|
1725057|NCT00622700|3177110|Superiority or Other||Hazard Ratio (HR)|0.686||||0.002|2-Sided|95.0|0.54|0.871||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The fourth step was the test of teriflunomide 7 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.|
1725058|NCT00622700|3177110|Superiority or Other||Hazard Ratio (HR)|0.651||||0.0003|2-Sided|95.0|0.515|0.822||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The third step was the test of teriflunomide 14 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.|
1725059|NCT00622700|3177111|Superiority or Other||Hazard Ratio (HR)|0.628||||0.0271|2-Sided|95.0|0.416|0.949||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure was used. The second step was the test of teriflunomide 7 mg versus placebo for time to conversion to CDMS. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.|
1725060|NCT00622700|3177111|Superiority or Other||Hazard Ratio (HR)|0.574||||0.0087|2-Sided|95.0|0.379|0.869||P value was derived using Wald chi-squared test in the Cox proportional hazard model.|Wald chi-squared|||A step-down hierarchical testing procedure, starting with the test of teriflunomide 14 mg versus placebo was used. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.|
1725061|NCT00622518|3177135|Superiority or Other|||||||0.002||||||P value is based on rating*group interaction term|linear mixed model||||
1725478|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-1.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)|
1725062|NCT00622440|3177139|Other||Wilcoxon Rank Sum Effect Size|0.275||||0.042|2-Sided|95.0|||||Wilcoxon rank sum||The wilcoxon rank sum effect size ranges in strength of effect from small (0.10 - < 0.30), to medium (0.30 - < 0.50), to large (>=0.50) with a total range of 0 to 1|Estimated Effect Size for Phase 3 Trial|
1725063|NCT00622388|3177158|Superiority or Other||Response rate|11.0|||||2-Sided|95.0|5.0|20.0|||||Response rate is calculated as the number of responses divided by the number of participants treated, expressed as a percentage.||
1725064|NCT00622284|3177179|Superiority or Other||Least Squares Mean Difference|-9.47|Standard Error of the Mean|5.77||0.0918||95.0|-21.07|1.59|||ANCOVA|||Linagliptin versus Glimepiride|
1725065|NCT00622284|3177180|Superiority or Other||Odds Ratio (OR)|0.7||||0.0018||95.0|0.56|0.875|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride|
1725066|NCT00622284|3177181|Superiority or Other||Odds Ratio (OR)|0.689||||0.024||95.0|0.498|0.952|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride|
1725067|NCT00622284|3177182|Superiority or Other||Odds Ratio (OR)|0.648||||0.0025||95.0|0.489|0.859|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride|
1725068|NCT00622284|3177183|Superiority or Other||Odds Ratio (OR)|0.654||||0.003||95.0|0.494|0.866|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride|
1725069|NCT00622284|3177184|Superiority or Other||Odds Ratio (OR)|0.625||||0.0004||95.0|0.482|0.811|||Regression, Logistic|The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.||Linagliptin versus Glimepiride|
1725070|NCT00622284|3177185|Superiority or Other||Least Squares Mean Difference|6.38|Standard Error of the Mean|1.97||0.0012||95.0|2.51|10.25|||ANCOVA|||Linagliptin versus Glimepiride|
1725071|NCT00622284|3177186|Superiority or Other||Least Squares Mean Difference|6.84|Standard Error of the Mean|1.7|<|0.0001||95.0|3.51|10.16|||ANCOVA|||Linagliptin versus Glimepiride|
1725072|NCT00622284|3177187|Superiority or Other||||||<|0.0001||||||Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.|Cochran-Mantel-Haenszel|||Linagliptin versus Glimepiride|
1725073|NCT00622284|3177188|Superiority or Other||||||<|0.0001||||||This key secondary endpoint was only to be tested (comparing to a 2-sided threshold of 0.025) if the Week52 body weight change from baseline was confirmatory.|Cochran-Mantel-Haenszel|||Linagliptin versus Glimepiride|
1725074|NCT00622284|3177189|Superiority or Other||Least Squares Mean Difference|-2.68|Standard Error of the Mean|0.22|<|0.0001||97.5|-3.17|-2.19||Due to testing of multiple endpoints within a visit a sequential testing strategy (at 2-sided threshold of 0.025) was applied to the key secondary endpoints.|ANCOVA|||Linagliptin versus Glimepiride|
1725075|NCT00622284|3177190|Superiority or Other||Least Squares Mean Difference|-2.5|Standard Error of the Mean|0.18|<|0.0001||97.5|-2.91|-2.09||This Week52 key secondary endpoint was only to be tested (2-sided threshold of 0.025 to allow for multiple testing within a visit) if the Week52 primary hypothesis was rejected.|ANCOVA|||Linagliptin versus Glimepiride|
1725076|NCT00622284|3177191|Non-Inferiority or Equivalence|The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. However, superiority testing is only applicable if the Linagliptin decrease is greater than that in Glimepiride.|Least Squares Mean Difference|0.2|Standard Error of the Mean|0.05||0.0004||97.5|0.09|0.3||This 1-sided p-value should be compared to the 1-sided threshold of 0.0125 for non-inferiority. Due to the pre-specified hierarchial approach, further confirmatory analysis on the Week24 endpoints is only applicable if superiority is already met.|ANCOVA|||Linagliptin versus Glimepiride|
1725077|NCT00622284|3177192|Non-Inferiority or Equivalence|The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. Superiority testing was not part of the pre-specified Week 52 confirmatory analysis.|Least Squares Mean Difference|0.22|Standard Error of the Mean|0.04||0.0005||97.5|0.13|0.31||Due to multiple testing of the primary endpoints at weeks 52 and 104 a Bonferroni correction was applied and 97.5% confidence intervals produced. This 1-sided p-value for non-inferiority should be compared to the 1-sided threshold of 0.0125.|ANCOVA|||Linagliptin versus Glimepiride|
1725078|NCT00622167|3177194|Superiority or Other|||||||0|||||||Not done|||Plaque characteristics including plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology would be compared between IBIVUS, DSCT and angiography.|
1725079|NCT00621985|3177195|Superiority or Other||Percent Difference|-19.0||||0.09||95.0|||||t-test, 2 sided|||"A t-test was performed comparing the mean long transformed area under the curve of 17-hydroxyprogesterone between the dexamethasone and hydrocortisone arms. The percent difference in mean log AUC was calculated as:~(Mean log AUC on dexamethasone - Mean log AUC on hydrocortisone)/Mean log AUC on hydrocortisone"|
1725080|NCT00621959|3177196|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.442||95.0|-0.27|0.12||If the p-value of this estimated difference is lower than 5% the mean change from baseline in overall RQLQ score is considered as different between the two treatment groups.|ANCOVA|ANCOVA on the change from baseline in overall RQLQ score including treatment and pooled center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis is expressed as follows: ‘The mean change from baseline in overall RQLQ score at endpoint visit is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1725081|NCT00621959|3177197|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.546||95.0|-0.59|0.31||If the p-value of this estimated difference is lower than 5% the mean T5SS is considered as different between the two treatment groups.|ANCOVA|ANCOVA including treatment and center as factors and baseline mean score as covariate.|The difference presented is 'Levocetirizine 5 mg - Placebo'|The Null Hypothesis for the primary endpoint is expressed as follows: ‘The mean 24-hr reflective T5SS over the total treatment period is not different from subjects treated with levocetirizine than subjects treated with placebo.’|
1725109|NCT00621140|3177323|Superiority or Other||Mean Difference (Final Values)|-0.66|Standard Error of the Mean|0.08|<|0.0001||95.0|-0.82|-0.49|||ANCOVA|||Linagliptin vs. Placebo|
1726496|NCT00599872|3180591|Superiority or Other||Mean Difference (Net)|0.36|||<|0.05|2-Sided|95.0|-1.72|0.63|||ANCOVA||||
1725082|NCT00621855|3177211|Superiority or Other||||||<|0.001|||||||Cochran-Armitage test for linear trend|||"The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response).~The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0)"|
1725083|NCT00621855|3177214|Superiority or Other||||||<|0.001|||||||Cochran-Armitage test for linear trend|||"The proportion of patients who reach this endpoint were analysed by a logistic model for linear trend (dose response).~The null hypothesis is that the relationship between dose level (0mg, 50mg, 75mg, 110mg and 150mg) and the proportions of patients with major and clinically relevant minor bleeding is not linear (slope parameter = 0)"|
1725084|NCT00621842|3177217|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.04||95.0|-1.03|-0.04|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.|
1725085|NCT00621842|3177218|Superiority or Other||Mean Difference (Final Values)|-0.79||||0.08|2-Sided|95.0|-1.67|0.09|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.|
1725086|NCT00621842|3177220|Superiority or Other||Mean Difference (Final Values)|0.83||||0.36||95.0|-0.97|2.62|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.|
1725087|NCT00621842|3177221|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.8|2-Sided|95.0|-0.36|0.28|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.|
1725088|NCT00621842|3177222|Superiority or Other||Mean Difference (Final Values)|-2.06|||<|0.01|2-Sided|95.0|-2.43|-1.68|||t-test, 2 sided|||The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.|
1725089|NCT00621842|3177223|Superiority or Other||Mean Difference (Final Values)|-0.47||||0.49|2-Sided|95.0|-1.82|0.88|||t-test, 2 sided|||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.|
1725090|NCT00621842|3177224|Superiority or Other||Mean Difference (Final Values)|-15.2|||<|0.01|2-Sided|95.0|-17.5|-12.9|||t-test, 2 sided|||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.|
1725091|NCT00621842|3177226|Superiority or Other||Mean Difference (Final Values)|-15.5|||<|0.01|2-Sided|95.0|-18.0|-12.9|||t-test, 2 sided|df=53||The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.|
1725092|NCT00621686|3177237|Superiority or Other|||||||0.069|||||||Log Rank||||
1725093|NCT00621582|3177244|Superiority or Other|||||||0.01|||||||Chi-squared|||comparing results of post-treatment global assessment by patient with that of pre-treatment|
1725094|NCT00621530|3177247|Superiority||||||=|0|||||||ANOVA|Repeated measures ANOVA|||
1725095|NCT00621530|3177248|Superiority||||||=|0|||||||ANOVA|Repeated measures ANOVA|||
1725096|NCT00621530|3177249|Superiority||||||=|0|||||||ANOVA|Repeated measures ANOVA|||
1725097|NCT00621530|3177250|Superiority||||||=|0|||||||ANOVA|Repeated measures ANOVA|||
1725098|NCT00621530|3177251|Superiority||Median Difference (Final Values)|0.0|||=|0|2-Sided||||||Wilcoxon (Mann-Whitney)|||Power calculation assumed that all subjects would have an area of hypersensitivity surrounding the wound at 48 hours. We found that only 1 subject in the placebo group and 3 subjects in the ketorolac group had non-zero areas of hypersensitivity.|
1725099|NCT00621504|3177263|Non-Inferiority or Equivalence|A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on each of the CE and the MITTE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than –10% for each of the CE and MITTE Populations.|Risk Difference (RD)|6.2|||||2-Sided|95.0|-0.2|12.6|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE and MITTE Populations in adult subjects with CABP.|
1725100|NCT00621348|3177267|Non-Inferiority or Equivalence|Equivalence analysis|Risk Ratio (RR)|0.12|Standard Error of the Mean|0.0|<|0.05|2-Sided|95.0|0.016|0.93||p value was adjusted for multiple comparisons.|Fisher Exact||The risk ratio is for Group A compared with Group C.|The incidence of hospital-acquired hyponatremia with current standard intravenous fluid therapy was approximately 30%. Sample of 72 patients would be needed in each group to demonstrate the decrease in incidence of hyponatremia (defined as plasma sodium< 130 mEq/L) to 10%, with a power of 80 percent and alpha error of 0.05. In view of short study period and feasibility it was planned a priori to enroll at least 50 patients in each treatment limb.|
1725101|NCT00621140|3177313|Superiority or Other||Mean Difference (Final Values)|-58.38|Standard Deviation|12.05|<|0.0001||95.0|-82.33|-34.43|||ANCOVA|||Linagliptin vs. Placebo|
1725102|NCT00621140|3177314|Superiority or Other||Odds Ratio (OR)|4.243|||<|0.0001||95.0|2.665|6.755|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."|
1725103|NCT00621140|3177316|Superiority or Other||Odds Ratio (OR)|2.436||||0.0323||95.0|1.078|5.507|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."|
1725104|NCT00621140|3177318|Superiority or Other||Odds Ratio (OR)|2.869||||0.0006||95.0|1.575|5.225|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."|
1725105|NCT00621140|3177319|Superiority or Other||Mean Difference (Final Values)|-20.36|Standard Error of the Mean|3.4|<|0.0001||95.0|-27.05|-13.68|||ANCOVA|||Linagliptin vs. Placebo|
1725106|NCT00621140|3177320|Superiority or Other||Mean Difference (Final Values)|-20.98|Standard Error of the Mean|3.17|<|0.0001||95.0|-27.21|-14.75|||ANCOVA|||Linagliptin vs. Placebo|
1725107|NCT00621140|3177321|Superiority or Other||Mean Difference (Final Values)|-17.6|Standard Error of the Mean|2.81|<|0.0001||95.0|-23.11|-12.08|||ANCOVA|||Linagliptin vs. Placebo|
1725310|NCT00618995|3177668|Superiority or Other||Geometric least-squares mean ratio|0.87||||||90.0|0.71|1.05|||||||
1725110|NCT00621140|3177324|Superiority or Other||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.08|<|0.0001||95.0|-0.76|-0.47|||ANCOVA|||Linagliptin vs. Placebo|
1725111|NCT00621140|3177325|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.06|<|0.0001||95.0|-0.58|-0.34|||ANCOVA|||Linagliptin vs. Placebo|
1725112|NCT00621140|3177326|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.08|<|0.0001||95.0|-0.85|-0.53|||ANCOVA|||Linagliptin vs. Placebo|
1725113|NCT00620828|3177337|Superiority or Other|||||||0.05|||||||Chi-squared|||Straight leg raise data collected at 4-hours, 8-hours, 12-hours and 24-hours post-operatively for patient cohort.|
1725114|NCT00620828|3177338|Superiority or Other|||||||0.05|||||||t-test, 1 sided|||Knee extension and knee flexion measured at 24-hours post-operatively for patient cohort.|
1725115|NCT00620828|3177339|Superiority or Other|||||||0.05|||||||t-test, 1 sided|||This analysis was performed on data collected 24-hours post-operatively for patient cohort.|
1725116|NCT00620828|3177340|Superiority or Other|||||||0.05|||||||ANOVA|||Significant differences in Fentanyl PCA pump usage across study arms were assessed for the 4-8h,8-12h,and 12h-24h time frames.|
1725117|NCT00620828|3177341|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Patient cohort was inclusive of patient undergoing single TKA from June 2007 to July 2008. Effect size was calculated for the numeric pain rating scale at the immediate post-operative period, 4-hour, 8-hour , 12-hour, and 24-hour time periods as a means to assess post-operative pain control.|
1725118|NCT00620815|3177350|Non-Inferiority or Equivalence|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.92|||||2-Sided|96.67|0.81|1.04||||||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0].|
1725119|NCT00620815|3177350|Non-Inferiority or Equivalence|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.05|||||2-Sided|96.67|0.93|1.19||||||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0].|
1725120|NCT00620815|3177350|Non-Inferiority or Equivalence|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.14|||||2-Sided|96.67|1.01|1.3||||||(On day 43) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0].|
1725121|NCT00620815|3177350|Non-Inferiority or Equivalence|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.71|||||2-Sided|96.67|0.44|1.15||||||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0].|
1725122|NCT00620815|3177350|Non-Inferiority or Equivalence|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|0.85|||||2-Sided|96.67|0.52|1.38||||||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0].|
1725123|NCT00620815|3177350|Non-Inferiority or Equivalence|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.19|||||2-Sided|96.67|0.74|1.93||||||(On day 22) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0].|
1725124|NCT00620815|3177350|Non-Inferiority or Equivalence|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratio|0.89|||||2-Sided|96.67|0.8|0.99||||||(On day 1)Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0].|
1725125|NCT00620815|3177350|Non-Inferiority or Equivalence|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Geometric Mean Ratios|1.01|||||2-Sided|96.67|0.91|1.12||||||(On day 1) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0].|
1725126|NCT00620815|3177350|Non-Inferiority or Equivalence|To show statistical equivalence was, confidence intervals (CIs) of all 3 pair wise ratios of the GMAs were inspected.|Group Mean Ratio|1.13|||||2-Sided|96.67|1.02|1.25||||||(On day 1) Null hypothesis representing non-equivalence was rejected if the two-sided (1-2α)*100% CI on one GMA ratio is completely within the equivalence range [0.5, 2.0].|
1725127|NCT00620776|3177351|Superiority or Other|||||||0.52|||||||Chi-squared||||
1725128|NCT00620776|3177352|Superiority or Other|||||||0.63|||||||Chi-squared||||
1725129|NCT00620776|3177353|Superiority or Other|||||||0.07|||||||ANCOVA|||Data collected at week 24 were analyzed with ANCOVA including baseline data as covariate.|
1725130|NCT00620776|3177354|Superiority or Other|||||||0.23|||||||ANCOVA|||Data collected at week 24 were analyzed with ANCOVA with baseline data as covariate.|
1725131|NCT00620776|3177355|Superiority or Other|||||||0.53|||||||ANCOVA|||Data collected at week 24 were analyzed using ANCOVA with the baseline score as the covariate.|
1725132|NCT00620776|3177356|Superiority or Other|||||||0.17|||||||ANCOVA|||Data collected at week 24 were analyzed using ANCOVA with the baseline score as the covariate.|
1725133|NCT00620776|3177357|Superiority or Other|||||||0.95|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).|
1725134|NCT00620776|3177358|Superiority or Other|||||||0.06|||||||ANCOVA|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).|
1725135|NCT00620776|3177359|Superiority or Other|||||||0.051|||||||ANCOVA|||Data collected at week 24 were analyzed using analysis of covariance (ANCOVA) with the baseline score as the covariate.|
1725311|NCT00618995|3177668|Superiority or Other||Geometric least-squares mean ratio|0.94||||||90.0|0.77|1.14|||||||
1725136|NCT00620776|3177360|Superiority or Other|||||||0.86|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).|
1725137|NCT00620776|3177361|Superiority or Other|||||||0.54|||||||Mixed Models Analysis|||Analyses were conducted using mixed effects models that tested for differential slopes over time between the CBT plus venlafaxine XR and venlafaxine XR alone groups using only available scores (no imputation for missing data).|
1725138|NCT00620776|3177362|Superiority or Other|||||||0.17|||||||Mixed Models Analysis|||Mixed model analysis (differential slopes over time) comparing the 26 patients who received combined treatment with at least one CBT session to the 35 patients randomized to venlafaxine XR alone (and received at least one dose) on HAM-A total scores. Only available scores were used (no imputation for missing data). Because the HAM-A demonstrated a relatively rapid improvement early in treatment and then a leveling off, a shifted log-transformation of time of assessment was implemented.|
1725139|NCT00620763|3177363|Superiority or Other||Mean Difference (Final Values)|5.0|Standard Error of the Mean|2.0||0.02||95.0|||||Mixed Models Analysis|Mixed model analysis of variance tested for treatment and feeding sequence effects.||16 subjects required to detect a difference in Calcium 47 absorption of 2 percentage points with 90% power, alpha = 0.05|
1725140|NCT00620659|3177370|Superiority or Other|||||||0.003|||||||Mixed Models Analysis|The mixed model included terms for period and treatment.|||
1725141|NCT00620659|3177371|Superiority or Other|||||||0.079|||||||Mixed Models Analysis|The mixed model included terms for period and treatment.|||
1725142|NCT00620659|3177372|Non-Inferiority or Equivalence|The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.|Difference in Least Squares Mean|-3.8|||||2-Sided|90.0|-5.23|-2.38|||||||
1725143|NCT00620659|3177373|Non-Inferiority or Equivalence|The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.|Difference in Least Squares Mean|-4.11|||||2-Sided|90.0|-5.92|-2.3|||||||
1725144|NCT00620659|3177374|Superiority or Other|||||||0.615|||||||Mixed Models Analysis|The mixed model included terms for period and treatment.|||
1725145|NCT00620464|3177400|Superiority or Other||||||<=|0|||||||Bioequivalence Testing||||
1725146|NCT00620464|3177401|Superiority or Other|||||||0.05||||||Applies to all parameters.|Bioequivalence Testing||||
1725147|NCT00620373|3177403|Superiority or Other|||||||0.218|||||||McNemar|||significant difference p ≤ 0.05|
1725148|NCT00620373|3177403|Superiority or Other||||||<|0.001|||||||McNemar|||significant difference p ≤ 0.05|
1725149|NCT00620373|3177404|Superiority or Other|||||||0.069|||||||McNemar|||significant difference p ≤ 0.05|
1725150|NCT00620373|3177404|Superiority or Other||||||<|0.001|||||||McNemar|||significant difference p ≤ 0.05|
1725151|NCT00620373|3177406|Superiority or Other||||||>|0.99|||||||McNemar|||For ductal carcinoma in situ; significant difference p ≤ 0.05|
1725152|NCT00620373|3177406|Superiority or Other||||||>|0.5|||||||McNemar|||For ductal carcinoma in situ; significant difference p ≤ 0.05|
1725153|NCT00620373|3177406|Superiority or Other||||||>|0.063|||||||McNemar|||For invasive cancers; significant difference p ≤ 0.05|
1725154|NCT00620373|3177406|Superiority or Other||||||>|0.063|||||||McNemar|||For invasive cancers; significant difference p ≤ 0.05|
1725155|NCT00620373|3177406|Superiority or Other||||||>|0.07|||||||McNemar|||For all cancers; significant difference p ≤ 0.05|
1725156|NCT00620373|3177406|Superiority or Other||||||>|0.016|||||||McNemar|||For all cancers; significant difference p ≤ 0.05|
1725157|NCT00620373|3177407|Superiority or Other|||||||0.07|||||||McNemar|||significant difference p ≤ 0.05|
1725158|NCT00620373|3177407|Superiority or Other|||||||0.016|||||||t-test, 2 sided|||Significant difference p ≤ 0.05|
1725159|NCT00620282|3177418|Superiority or Other||Least squares mean|-0.402||||0.2465||95.0|-1.097|0.293||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.|
1725160|NCT00620282|3177418|Superiority or Other||Least squares mean|-0.018||||0.9569||95.0|-0.697|0.661||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.|
1725161|NCT00620282|3177418|Superiority or Other||Least squares mean|-0.42||||0.2282||95.0|-1.118|0.278||2-sided significance level of 5%.|ANCOVA|||Change in TNF-alpha from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TNF-alpha as a covariate.|
1725162|NCT00620282|3177419|Superiority or Other||Least squares mean|-32.923||||0.0994||95.0|-72.353|6.507||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.|
1725163|NCT00620282|3177419|Superiority or Other||Least squares mean|-3.786||||0.844||95.0|-42.373|34.801||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.|
1725164|NCT00620282|3177419|Superiority or Other||Least squares mean|-36.709||||0.0694||95.0|-76.467|3.048||2-sided significance level of 5%.|ANCOVA|||Change in TG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TG as a covariate.|
1725165|NCT00620282|3177420|Superiority or Other||Least squares mean|0.554||||0.7283||95.0|-2.643|3.751||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.|
1725339|NCT00618722|3177731|Superiority or Other||LS Mean Difference|-0.4||||0.043|2-Sided|95.0|-0.9|0.0|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.|||
1725166|NCT00620282|3177420|Superiority or Other||Least squares mean|-0.723||||0.6362||95.0|-3.785|2.339||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.|
1725167|NCT00620282|3177420|Superiority or Other||Least squares mean|-0.169||||0.9131||95.0|-3.273|2.935||2-sided significance level of 5%.|ANCOVA|||Change in HDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HDL-C as a covariate.|
1725168|NCT00620282|3177421|Superiority or Other||Least squares mean|0.929||||0.8822||95.0|-11.646|13.505||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.|
1725169|NCT00620282|3177421|Superiority or Other||Least squares mean|2.773||||0.6517||95.0|-9.537|15.082||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.|
1725170|NCT00620282|3177421|Superiority or Other||Least squares mean|3.702||||0.5583||95.0|-8.96|16.365||2-sided significance level of 5%.|ANCOVA|||Change in LDL-C from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline LDL-C as a covariate.|
1725171|NCT00620282|3177422|Superiority or Other||Least squares mean|-4.149||||0.5903||95.0|-19.582|11.284||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.|
1725172|NCT00620282|3177422|Superiority or Other||Least squares mean|1.912||||0.7993||95.0|-13.168|16.991||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.|
1725173|NCT00620282|3177422|Superiority or Other||Least squares mean|-2.237||||0.7736||95.0|-17.829|13.354||2-sided significance level of 5%.|ANCOVA|||Change in TC from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline TC as a covariate.|
1725174|NCT00620282|3177423|Superiority or Other||Least squares mean|1.331||||0.0486||95.0|0.009|2.653||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.|
1725175|NCT00620282|3177423|Superiority or Other||Least squares mean|-2.859||||||95.0|-4.139|-1.579||||||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.|
1725176|NCT00620282|3177423|Superiority or Other||Least squares mean|-1.528||||0.0268||95.0|-2.873|-0.184||2-sided significance level of 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline body weight as a covariate.|
1725177|NCT00620282|3177424|Superiority or Other||Least squares mean|-15.686||||0.2651||95.0|-43.838|12.466||2-sided significance level of 5%.|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.|
1725178|NCT00620282|3177424|Superiority or Other||Least squares mean|3.815||||0.7622||95.0|-21.618|29.247||2-sided significance level of 5%|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.|
1725179|NCT00620282|3177424|Superiority or Other||Least squares mean|-11.871||||0.4121||95.0|-40.943|17.201||2-sided significance level of 5%.|ANCOVA|||Change in PPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline PPG as a covariate.|
1725180|NCT00620282|3177425|Superiority or Other||Least squares mean|-25.952||||||95.0|-37.429|-14.475||||||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.|
1725181|NCT00620282|3177425|Superiority or Other||Least squares mean|-9.653||||0.0677||95.0|-20.041|0.736||2-sided significance level of 5%.|ANCOVA|||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.|
1725182|NCT00620282|3177425|Superiority or Other||Least squares mean|-35.605||||||95.0|-46.797|-24.413||||||Change in FPG from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FPG as a covariate.|
1725183|NCT00620282|3177426|Superiority or Other||Least squares mean|-0.458||||0.0098||95.0|-0.8|-0.116||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|
1725184|NCT00620282|3177426|Superiority or Other||Least squares mean|-0.077||||0.6207||95.0|-0.391|0.236||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|
1725185|NCT00620282|3177426|Superiority or Other||Least squares mean|-0.536||||0.0023||95.0|-0.868|-0.203||2-sided significance level of 5%.|ANCOVA|||Change in HbA1c from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|
1725186|NCT00620282|3177427|Superiority or Other||Least squares mean|3.79||||0.3435||95.0|-4.194|11.774||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.|
1725187|NCT00620282|3177427|Superiority or Other||Least squares mean|0.709||||0.8518||95.0|-6.904|8.322||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.|
1725188|NCT00620282|3177427|Superiority or Other||Least squares mean|4.499||||0.2648||95.0|-3.535|12.534||2-sided significance level of 5%.|ANCOVA|||Change in SNP-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.|
1725189|NCT00620282|3177428|Superiority or Other||Least squares mean|5.35||||0.1668||95.0|-2.323|13.024||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.|
1725190|NCT00620282|3177428|Superiority or Other||Least squares mean|2.08||||0.5681||95.0|-5.215|9.375||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.|
1725191|NCT00620282|3177428|Superiority or Other||Least squares mean|7.43||||0.0549||95.0|-0.164|15.025||2-sided significance level of 5%.|ANCOVA|||Change in Ach-mediated FBF from baseline to end of treatment at 12 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline FBF as a covariate.|
1725192|NCT00620113|3177432|Superiority or Other||Difference in LS Means|-5.61||||0.458|2-Sided|95.0|-23.79|12.56||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725193|NCT00620113|3177432|Superiority or Other||Difference in LS Means|-28.86|||<|0.001|2-Sided|95.0|-44.97|-12.75||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725194|NCT00620113|3177432|Superiority or Other||Difference in LS Means|-26.86|||<|0.001|2-Sided|95.0|-43.3|-10.42||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725195|NCT00620113|3177433|Superiority or Other||Difference in LS Means|2.48||||0.598|2-Sided|95.0|-7.79|12.74||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725196|NCT00620113|3177433|Superiority or Other||Difference in LS Means|-12.55||||0.009|2-Sided|95.0|-22.16|-2.94||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725197|NCT00620113|3177433|Superiority or Other||Difference in LS Means|-15.52|||<|0.001|2-Sided|95.0|-25.11|-5.93||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725198|NCT00620113|3177434|Superiority or Other||Difference in LS Means|-26.77||||0.017|2-Sided|95.0|-50.37|-3.16||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725199|NCT00620113|3177434|Superiority or Other||Difference in LS Means|-37.45||||0.001|2-Sided|95.0|-60.32|-14.59||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725340|NCT00618618|3177734|Superiority or Other||LS Mean Difference|1.4||||0.688|2-Sided|95.0|-5.4|8.1|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.|||
1725341|NCT00618618|3177734|Superiority or Other||LS Mean Difference|1.8||||0.653|2-Sided|95.0|-6.3|9.9|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.|||
1725200|NCT00620113|3177434|Superiority or Other||Difference in LS Means|-42.91|||<|0.001|2-Sided|95.0|-65.55|-20.27||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725201|NCT00620113|3177435|Superiority or Other||Difference in LS Means|-38.73|||<|0.001|2-Sided|95.0|-65.94|-11.52||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725202|NCT00620113|3177435|Superiority or Other||Difference in LS Means|-60.7|||<|0.001|2-Sided|95.0|-85.91|-35.49||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725203|NCT00620113|3177435|Superiority or Other||Difference in LS Means|-60.42|||<|0.001|2-Sided|95.0|-85.7|-35.13||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725204|NCT00620113|3177436|Superiority or Other||Difference in LS Means|-35.75|||<|0.001|2-Sided|95.0|-52.33|-19.16||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725205|NCT00620113|3177436|Superiority or Other||Difference in LS Means|-44.32|||<|0.001|2-Sided|95.0|-60.42|-28.21||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725206|NCT00620113|3177436|Superiority or Other||Difference in LS Means|-50.64|||<|0.001|2-Sided|95.0|-66.43|-34.84||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||The log-transformed fraction from baseline in biomarker levels was analyzed using an ANCOVA model with terms for treatment and study center, using a stepwise linear contrast test based on the ANCOVA model. The geometric mean percent change from baseline (back-transformation from the mean log-transformed fraction) and the associated 95% confidence intervals were presented.|
1725207|NCT00620113|3177437|Superiority or Other||Difference in LS Means|2.43||||0.002|2-Sided|95.0|0.99|3.88||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.|
1725208|NCT00620113|3177437|Superiority or Other||Difference in LS Means|3.84|||<|0.001|2-Sided|95.0|2.37|5.3||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.|
1725209|NCT00620113|3177437|Superiority or Other||Difference in LS Means|4.66|||<|0.001|2-Sided|95.0|3.18|6.14||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.|
1725342|NCT00618618|3177734|Superiority or Other||LS Mean Difference|-1.9||||0.573|2-Sided|95.0|-8.6|4.8|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.|||
1725479|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-0.5|Standard Deviation|6.86|||2-Sided|95.0|-11.4|10.4||||||Mean change from Baseline to Week 48 (LOCF)|
1725210|NCT00620113|3177438|Superiority or Other||Difference in LS Means|2.23|||<|0.001|2-Sided|95.0|1.03|3.43||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.|
1725211|NCT00620113|3177438|Superiority or Other||Difference in LS Means|1.86|||<|0.003|2-Sided|95.0|0.64|3.08||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.|
1725212|NCT00620113|3177438|Superiority or Other||Difference in LS Means|3.08|||<|0.001|2-Sided|95.0|1.85|4.31||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.|
1725213|NCT00620113|3177441|Superiority or Other||Difference in LS Means|1.67|||<|0.001|2-Sided|95.0|0.77|2.57||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.|
1725214|NCT00620113|3177441|Superiority or Other||Difference in LS Means|2.2|||<|0.001|2-Sided|95.0|1.29|3.12||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.|
1725215|NCT00620113|3177441|Superiority or Other||Difference in LS Means|3.06|||<|0.001|2-Sided|95.0|2.14|3.98||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.|
1725216|NCT00620113|3177442|Superiority or Other||Difference in LS Means|3.54|||<|0.001|2-Sided|95.0|2.33|4.75||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 10 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.|
1725217|NCT00620113|3177442|Superiority or Other||Difference in LS Means|5.12|||<|0.001|2-Sided|95.0|3.9|6.35||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 25 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an ANCOVA model with terms for treatment and study center. Treatment effect was assessed by LS mean and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.|
1725218|NCT00620113|3177442|Superiority or Other||Difference in LS Means|5.4|||<|0.001|2-Sided|95.0|4.16|6.64||The stepwise linear trend test adjusted for multiplicity within the family of comparisons of active doses with placebo and preserved the Type I error rate. P-value is for Placebo through Odanacatib 50 mg dose.|ANCOVA|||Analysis for percent change from baseline to Week 52 in BMD was performed using a stepwise linear contrast test based on an analysis of covariance (ANCOVA) model with terms for treatment and study center. Treatment effect was assessed by Least-Squares means (LS mean) and the associated 95% confidence intervals. Estimated difference from placebo = odanacatib dose minus placebo dose. Positive mean treatment differences were in favor of odanacatib.|
1725219|NCT00619983|3177469|Superiority|||||||0.69|||||||ANOVA|Repeated measures ANOVA||Due to failure of daily electronic diaries and exhaustion of funds, we were only able to recruit < 30% of the number of subjects required in our power analysis.|
1725220|NCT00619957|3177472|Superiority or Other||Relative Risk|0.688||||0.5293|2-Sided|95.0|0.245|1.932|||Log Rank|||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725221|NCT00619957|3177473|Superiority or Other||Relative Risk|0.771||||0.7284||95.0|0.184|3.226|||Log Rank|||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725222|NCT00619957|3177474|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Controlled for pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725223|NCT00619957|3177475|Superiority or Other||LS Mean Difference|-0.29||||0.784|2-Sided|95.0|-2.39|1.81|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725224|NCT00619957|3177476|Superiority or Other||LS Mean Difference|-0.47||||0.6658|2-Sided|95.0|-2.62|1.67|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725225|NCT00619957|3177477|Superiority or Other||LS Mean Difference|-0.14||||0.8794|2-Sided|95.0|-1.99|1.71|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725226|NCT00619957|3177478|Superiority or Other||LS Mean Difference|-27.25|||<|0.0001|2-Sided|95.0|-37.63|-16.87|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725227|NCT00619957|3177479|Superiority or Other||LS Mean Difference|-28.15|||<|0.0001|2-Sided|95.0|-39.84|-16.47|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725228|NCT00619957|3177480|Superiority or Other||LS Mean Difference|-22.39|||<|0.0001|2-Sided|95.0|-27.8|-16.98|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725229|NCT00619957|3177481|Superiority or Other||LS Mean Difference|-21.1|||<|0.0001|2-Sided|95.0|-25.61|-16.59|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725230|NCT00619957|3177482|Superiority or Other||LS Mean Difference|-15.64|||<|0.0001|2-Sided|95.0|-19.29|-11.99|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725231|NCT00619957|3177483|Superiority or Other||LS Mean Difference|-16.37||||0.0003|2-Sided|95.0|-25.24|-7.49|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725232|NCT00619957|3177484|Superiority or Other||LS Mean Difference|-15.11||||0.0012|2-Sided|95.0|-24.2|-6.02|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725467|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.4|Standard Deviation|0.83||||||||||||Mean change from Baseline to Week 24 (LOCF)|
1725233|NCT00619957|3177485|Superiority or Other||LS Mean Difference|-21.96|||<|0.0001|2-Sided|95.0|-30.75|-13.17|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725234|NCT00619957|3177486|Superiority or Other||LS Mean Difference|-22.0|||<|0.0001|2-Sided|95.0|-31.08|-12.91|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725235|NCT00619957|3177487|Superiority or Other||LS Mean Difference|-15.88|||<|0.0001|2-Sided|95.0|-23.43|-8.32|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725236|NCT00619957|3177488|Superiority or Other||LS Mean Difference|-45.15|||<|0.0001|2-Sided|95.0|-57.01|-33.29|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725237|NCT00619957|3177489|Superiority or Other||LS Mean Difference|-46.55|||<|0.0001|2-Sided|95.0|-59.38|-33.72|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725238|NCT00619957|3177490|Superiority or Other||LS Mean Difference|-42.33|||<|0.0001|2-Sided|95.0|-55.99|-28.67|||ANOVA|Fixed effects for treatment and pooled centers.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725239|NCT00619957|3177491|Superiority or Other||LS Mean Difference|-44.72|||<|0.0001|2-Sided|95.0|-58.01|-31.43|||ANOVA|Fixed effects for treatment and pooled center||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725240|NCT00619957|3177492|Superiority or Other||LS Mean Difference|-43.6|||<|0.0001|2-Sided|95.0|-51.52|-35.67|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725241|NCT00619957|3177493|Superiority or Other||LS Mean Difference|2.15|||<|0.0001|2-Sided|95.0|1.22|3.08|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725242|NCT00619957|3177494|Superiority or Other||LS Mean Difference|2.31|||<|0.0001|2-Sided|95.0|1.35|3.26|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725243|NCT00619957|3177495|Superiority or Other||LS Mean Difference|1.07||||0.0129|2-Sided|95.0|0.23|1.92|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725244|NCT00619957|3177496|Superiority or Other||LS Mean Difference|0.57||||0.1408|2-Sided|95.0|-0.19|1.34|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1727194|NCT00587587|3182056|Superiority or Other|||||||0.5863|||||||Wilcoxon (Mann-Whitney)||||
1725245|NCT00619957|3177497|Superiority or Other||LS Mean Difference|1.06||||0.0187|2-Sided|95.0|0.18|1.94|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725246|NCT00619957|3177498|Superiority or Other||LS Mean Difference|1.24||||0.0081|2-Sided|95.0|0.32|2.15|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725247|NCT00619957|3177499|Superiority or Other||LS Mean Difference|0.86||||0.0537|2-Sided|95.0|-0.01|1.74|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725248|NCT00619957|3177500|Superiority or Other||LS Mean Difference|0.5||||0.2538|2-Sided|95.0|-0.36|1.36|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725249|NCT00619957|3177501|Superiority or Other||LS Mean Difference|1.46|||<|0.0001|2-Sided|95.0|0.76|2.17|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725250|NCT00619957|3177502|Superiority or Other||LS Mean Difference|1.7|||<|0.0001|2-Sided|95.0|0.98|2.41|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725251|NCT00619957|3177503|Superiority or Other||LS Mean Difference|0.65||||0.0346|2-Sided|95.0|0.05|1.25|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725252|NCT00619957|3177504|Superiority or Other||LS Mean Difference|0.4||||0.1856|2-Sided|95.0|-0.19|0.99|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725253|NCT00619957|3177505|Superiority or Other||LS Mean Difference|4.57|||<|0.0001|2-Sided|95.0|3.49|5.66|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725254|NCT00619957|3177506|Superiority or Other||LS Mean Difference|3.18|||<|0.0001|2-Sided|95.0|2.19|4.16|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725255|NCT00619957|3177507|Superiority or Other||LS Mean Difference|2.56|||<|0.0001|2-Sided|95.0|1.66|3.47|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1725256|NCT00619957|3177508|Superiority or Other||Least Square (LS) Mean Difference|4.53|||<|0.0001|2-Sided|95.0|3.46|5.6|||ANOVA|Fixed effects for treatment and pooled center.||A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.|
1727511|NCT00578968|3183003|Superiority or Other||||||<|0.05|||||||ANOVA||||
1725257|NCT00619866|3177537|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.09||0.119|2-Sided|95.0|-0.33|0.04|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725258|NCT00619866|3177537|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.09||0.0568|2-Sided|95.0|-0.36|0.01|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725259|NCT00619866|3177537|Superiority||LS Mean Difference|-0.15|Standard Error of the Mean|0.09||0.1002|2-Sided|95.0|-0.33|0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725260|NCT00619866|3177537|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.09||0.0012|2-Sided|95.0|-0.48|-0.12|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725261|NCT00619866|3177537|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.09||0.1855|2-Sided|95.0|-0.29|0.06|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725262|NCT00619866|3177537|Superiority||LS Mean Difference|-0.16|Standard Error of the Mean|0.09||0.0603|2-Sided|95.0|-0.34|0.01|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in total of non-menstrual pelvic pain and dysmenorrhea scores was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725263|NCT00619866|3177538|Superiority||LS Mean Difference|-0.52|Standard Error of the Mean|0.14||0.0003|2-Sided|95.0|-0.8|-0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725264|NCT00619866|3177538|Superiority||LS Mean Difference|-0.44|Standard Error of the Mean|0.14||0.0021|2-Sided|95.0|-0.72|-0.16|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725265|NCT00619866|3177538|Superiority||LS Mean Difference|-0.49|Standard Error of the Mean|0.14||0.0003|2-Sided|95.0|-0.76|-0.22|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725266|NCT00619866|3177538|Superiority||LS Mean Difference|-0.42|Standard Error of the Mean|0.14||0.0024|2-Sided|95.0|-0.68|-0.15|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725267|NCT00619866|3177538|Superiority||LS Mean Difference|-0.2|Standard Error of the Mean|0.13||0.121|2-Sided|95.0|-0.45|0.05|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725268|NCT00619866|3177538|Superiority||LS Mean Difference|-0.28|Standard Error of the Mean|0.13||0.0286|2-Sided|95.0|-0.54|-0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in dysmenorrhea score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725269|NCT00619866|3177539|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|0.08||0.7121|2-Sided|95.0|-0.18|0.12|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725270|NCT00619866|3177539|Superiority||LS Mean Difference|-0.05|Standard Error of the Mean|0.08||0.5558|2-Sided|95.0|-0.2|0.11|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725271|NCT00619866|3177539|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.08||0.5589|2-Sided|95.0|-0.19|0.1|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725272|NCT00619866|3177539|Superiority||LS Mean Difference|-0.18|Standard Error of the Mean|0.07||0.0195|2-Sided|95.0|-0.32|-0.03|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725273|NCT00619866|3177539|Superiority||LS Mean Difference|-0.03|Standard Error of the Mean|0.07||0.728|2-Sided|95.0|-0.17|0.12|||Repeated measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725274|NCT00619866|3177539|Superiority||LS Mean Difference|-0.04|Standard Error of the Mean|0.07||0.5744|2-Sided|95.0|-0.18|0.1|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in non-menstrual pelvic pain score was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725275|NCT00619866|3177540|Superiority||LS Mean Difference|-1.44|Standard Error of the Mean|0.5||0.0038|2-Sided|95.0|-2.42|-0.47|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725276|NCT00619866|3177540|Superiority||LS Mean Difference|-1.15|Standard Error of the Mean|0.5||0.0207|2-Sided|95.0|-2.13|-0.18|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 12. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725277|NCT00619866|3177540|Superiority||LS Mean Difference|-1.16|Standard Error of the Mean|0.48||0.0163|2-Sided|95.0|-2.1|-0.21|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725278|NCT00619866|3177540|Superiority||LS Mean Difference|-0.69|Standard Error of the Mean|0.48||0.1459|2-Sided|95.0|-1.63|0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725279|NCT00619866|3177540|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|0.46||0.5042|2-Sided|95.0|-1.21|0.59|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725280|NCT00619866|3177540|Superiority||LS Mean Difference|-0.12|Standard Error of the Mean|0.46||0.799|2-Sided|95.0|-1.01|0.78|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly peak values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725281|NCT00619866|3177541|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.25||0.3618|2-Sided|95.0|-0.71|0.26|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725282|NCT00619866|3177541|Superiority||LS Mean Difference|-0.52|Standard Error of the Mean|0.25||0.0354|2-Sided|95.0|-1.01|-0.04|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 8. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725283|NCT00619866|3177541|Superiority||LS Mean Difference|-0.23|Standard Error of the Mean|0.24||0.3375|2-Sided|95.0|-0.69|0.24|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725468|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.1|Standard Deviation|1.07||||||||||||Mean change from Baseline to Week 12 (LOCF)|
1725284|NCT00619866|3177541|Superiority||LS Mean Difference|-0.3|Standard Error of the Mean|0.24||0.2041|2-Sided|95.0|-0.77|0.17|||Repeated Measures ANCOVA||Difference = Elagolix - Placebo|Analysis at week 4. Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725285|NCT00619866|3177542|Superiority||LS Mean Difference|-0.36|Standard Error of the Mean|0.25||0.1521|2-Sided|95.0|-0.86|0.14|||Repeated Measures Analysis of Covariance||Difference = Elagolix - Placebo|Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725286|NCT00619866|3177542|Superiority||LS Mean Difference|-0.31|Standard Error of the Mean|0.25||0.2311|2-Sided|95.0|-0.81|0.2|||Repeated Measures Analysis of Covariance||Difference = Elagolix - Placebo|Change from baseline in in monthly mean values of the NRS for overall endometriosis-associated pelvic pain was analyzed by a repeated measures analysis of covariance model. The model included fixed effects for treatment, time, the treatment-by-time interaction, a random effect for subject, and the baseline-by-time interaction, and the baseline value as a covariate.|
1725287|NCT00619827|3177543|Superiority or Other||Mean Difference (Final Values)|-1.97||||0.0003|2-Sided|95.0|-2.99|-0.94|||ANCOVA||||
1725288|NCT00619476|3177619|Superiority or Other||Adjusted Mean difference versus placebo|-1.07||||0.002|2-Sided|95.0|-1.68|-0.45||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.|||
1725289|NCT00619476|3177619|Superiority or Other||Adjusted Mean difference versus placebo|-0.7||||0.029|2-Sided|95.0|-1.33|-0.07||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.|||
1725290|NCT00619476|3177619|Superiority or Other||Adjusted Mean difference versus placebo|-0.81||||0.013|2-Sided|95.0|-1.4|-0.23||This p-value has been adjusted for multiplicity using a step-down procedure that uses Dunnett's test within a closed testing scheme for multiple comparisons with a common control in order to maintain the overall experiment-wise alpha level of 0.05.|ANCOVA|An ANCOVA model with body mass index (BMI), baseline 24-hour average pain intensity, and grouped center as covariates was used.|||
1725291|NCT00619359|3177622|Non-Inferiority or Equivalence|If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥8.2 percentage points, fosaprepitant was considered at least as effective as aprepitant for No Vomiting in the overall phase.|Risk Difference (RD)|-1.7|Standard Error of the Mean|3.6||||95.0|-5.3|2.0|||||||
1725292|NCT00619359|3177623|Non-Inferiority or Equivalence|If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7.3 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the delayed phase.|Risk Difference (RD)|0.1|Standard Error of the Mean|3.6||||95.0|-3.5|3.7|||||||
1725293|NCT00619359|3177624|Non-Inferiority or Equivalence|If the CI for the difference in response rates (Fosaprepitant minus Aprepitant), calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the overall phase. Study had 90% power to detect non-inferiority for this outcome measure.|Risk Difference (RD)|-0.4|Standard Error of the Mean|3.7||||95.0|-4.1|3.3|||||||
1725294|NCT00619255|3177630|Superiority||Slope|1.35||||0.72|2-Sided||||||Chi-squared|DF=3|||
1725295|NCT00619255|3177631|Superiority||Slope|9.0||||0.03|2-Sided||||||Chi-squared|DF=3|||
1725296|NCT00619255|3177632|Superiority|||||||0.67|||||||Chi-squared|"DF = 1~Chi-Square Value = 0.18"|||
1725297|NCT00619255|3177633|Superiority||Slope|1.02||||0.8|2-Sided||||||Chi-squared|DF=3|||
1725298|NCT00619255|3177634|Superiority||Slope|1.38||||0.71|2-Sided||||||Chi-squared|DF=3|||
1725299|NCT00619229|3177646|Superiority or Other||Mean Difference (Final Values)|0.94||||0.122|2-Sided|95.0|-0.674|2.55||The criterion for significance (α) was set at one-sided α = 0.025, which means that only an effect in the expected direction was interpreted.|ANCOVA||For exploratory testing an Analysis of Variance-Covariance (ANCOVA) F-test with dependent variable 'difference in visual acuity', fixed factors ‘treatment’ and ‘centre’ and Baseline value as a covariate was used.|"The primary goal of the study was to test the following null hypothesis:~H0: μAlprostadil ≤ μPlacebo, against the alternative hypothesis H1: μAlprostadil > μPlacebo, where μ denotes the mean differences in visual acuity between measurements at 3 months after the end of study drug infusion minus measurements at baseline as assessed as line difference on the standard ETDRS charts."|
1725300|NCT00619060|3177666|Superiority or Other|||||||0.01|||||||Binomial||||
1725301|NCT00618995|3177667|Superiority or Other||Geometric least-squares mean ratio|0.57||||||90.0|0.51|0.64|||||||
1725302|NCT00618995|3177667|Superiority or Other||Geometric least-squares mean ratio|0.6||||||90.0|0.54|0.67|||||||
1725303|NCT00618995|3177667|Superiority or Other||Geometric least-squares mean ratio|0.54||||||90.0|0.48|0.6|||||||
1725304|NCT00618995|3177667|Superiority or Other||Geometric least-squares mean ratio|0.57||||||90.0|0.51|0.64|||||||
1725305|NCT00618995|3177667|Superiority or Other||Geometric least-squares mean ratio|0.94||||||90.0|0.84|1.05|||||||
1725306|NCT00618995|3177667|Superiority or Other||Geometric least-squares mean ratio|0.94||||||90.0|0.84|1.06|||||||
1725307|NCT00618995|3177668|Superiority or Other||Geometric least-squares mean ratio|0.9||||||90.0|0.74|1.09|||||||
1725308|NCT00618995|3177668|Superiority or Other||Geometric least-squares mean ratio|0.92||||||90.0|0.76|1.13|||||||
1725309|NCT00618995|3177668|Superiority or Other||Geometric least-squares mean ratio|0.84||||||90.0|0.69|1.02|||||||
1725312|NCT00618995|3177668|Non-Inferiority or Equivalence|Two treatments are comparable if the geometric mean ratio (GMR) is contained within the interval [0.50-2.00].|Geometric least-squares mean ratio|0.97||||||90.0|0.8|1.18||||||The endpoint is the urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval. The point estimate and 90% confidence intervals (CIs) were calculated for the geometric mean ratio (GMR) [Treatment A/B] of the urine levels of 11-dTxB2 on Day 7.|
1725313|NCT00618722|3177727|Superiority or Other||LS Mean Difference|9.3||||0.061|2-Sided|95.0|-0.4|19.1|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.|||
1725314|NCT00618722|3177727|Superiority or Other||LS mean Difference|5.2||||0.248|2-Sided|95.0|-3.8|14.2|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.|||
1725315|NCT00618722|3177727|Superiority or Other||LS Mean Difference|1.6||||0.762|2-Sided|95.0|-9.1|12.3|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.|||
1725316|NCT00618722|3177728|Superiority or Other||LS Mean Difference|0.1||||0.436|2-Sided|95.0|-0.2|0.4|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24|
1725317|NCT00618722|3177728|Superiority or Other||LS Mean Difference|-0.1||||0.41|2-Sided|95.0|-0.5|0.2|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24|
1725318|NCT00618722|3177728|Superiority or Other||LS Mean Difference|0.2||||0.205|2-Sided|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24|
1725319|NCT00618722|3177728|Superiority or Other||LS Mean Difference|0.1||||0.72|2-Sided|95.0|-0.3|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16|
1725320|NCT00618722|3177728|Superiority or Other||LS Mean Difference|-0.2||||0.33|2-Sided|95.0|-0.5|0.2|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16|
1725321|NCT00618722|3177728|Superiority or Other||LS Mean Difference|0.1||||0.51|2-Sided|95.0|-0.2|0.4|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16|
1725322|NCT00618722|3177728|Superiority or Other||LS Mean Difference|0.3||||0.081|2-Sided|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12|
1725323|NCT00618722|3177728|Superiority or Other||LS Mean Difference|0.4||||0.022|2-Sided|95.0|0.1|0.7|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12|
1725324|NCT00618722|3177728|Superiority or Other||LS Mean Difference|0.4||||0.017|2-Sided|95.0|0.1|0.7|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12|
1725325|NCT00618722|3177728|Superiority or Other||LS Mean Difference|0.2||||0.183|2-Sided|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8|
1725326|NCT00618722|3177728|Superiority or Other||LS Mean Difference|0.0||||0.975|2-Sided|95.0|-0.3|0.3|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8|
1725327|NCT00618722|3177728|Superiority or Other||LS Mean Difference|0.3||||0.076|2-Sided|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8|
1725328|NCT00618722|3177728|Superiority or Other||LS Mean Difference|0.2||||0.146|2-Sided|95.0|-0.1|0.5|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4|
1725329|NCT00618722|3177728|Superiority or Other||LS Mean Difference|0.0||||0.781|2-Sided|95.0|-0.3|0.4|||Repeated easures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4|
1725330|NCT00618722|3177728|Superiority or Other||LS Mean Difference|0.3||||0.078|2-Sided|95.0|0.0|0.6|||Repeated measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4|
1725331|NCT00618722|3177729|Superiority or Other||Difference from Placebo|44.7||||0.003|2-Sided|95.0|20.6|68.8|||Fisher Exact||||
1725332|NCT00618722|3177729|Superiority or Other||Difference from Placebo|28.9||||0.096|2-Sided|95.0|0.4|57.5|||Fisher Exact||||
1725333|NCT00618722|3177729|Superiority or Other||Difference from Placebo|38.9||||0.015|2-Sided|95.0|12.6|65.2|||Fisher Exact||||
1725334|NCT00618722|3177730|Superiority or Other||LS Mean Difference|1.6||||0.012|2-Sided|95.0|0.4|2.8|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.|||
1725335|NCT00618722|3177730|Superiority or Other||LS Mean Difference|1.4||||0.03|2-Sided|95.0|0.1|2.6|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.|||
1725336|NCT00618722|3177730|Superiority or Other||LS Mean Difference|1.9||||0.003|2-Sided|95.0|0.7|3.1|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.|||
1725337|NCT00618722|3177731|Superiority or Other||LS Mean Difference|-0.2||||0.249|2-Sided|95.0|-0.7|0.2|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.|||
1725338|NCT00618722|3177731|Superiority or Other||LS Mean Difference|-0.4||||0.05|2-Sided|95.0|-0.8|0.0|||ANCOVA|Based on analysis of covariance (ANCOVA) model with treatment as fixed effect and baseline SMF rating as covariate.|||
1725343|NCT00618618|3177736|Superiority or Other||LS Mean Difference|-0.6||||0.007|2-Sided|95.0|-1.0|-0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24|
1725344|NCT00618618|3177736|Superiority or Other||LS Mean Difference|-0.8|||<|0.001|2-Sided|95.0|-1.2|-0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24|
1725345|NCT00618618|3177736|Superiority or Other||LS Mean Difference|-0.6|||<|0.005|2-Sided|95.0|-0.9|-0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24|
1725346|NCT00618618|3177736|Superiority or Other||LS Mean Difference|-0.3|||<|0.122|2-Sided|95.0|-0.7|0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16|
1725347|NCT00618618|3177736|Superiority or Other||LS Mean Difference|-0.8|||<|0.001|2-Sided|95.0|-1.3|-0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16|
1725348|NCT00618618|3177736|Superiority or Other||LS Mean Difference|-0.5|||<|0.007|2-Sided|95.0|-0.9|-0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16|
1725349|NCT00618618|3177736|Superiority or Other||LS Mean Difference|-0.1|||<|0.489|2-Sided|95.0|-0.5|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12|
1725350|NCT00618618|3177736|Superiority or Other||LS Mean Difference|-0.5|||<|0.018|2-Sided|95.0|-0.9|-0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12|
1725351|NCT00618618|3177736|Superiority or Other||LS Mean Difference|-0.3|||<|0.128|2-Sided|95.0|-0.7|0.1|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12|
1725352|NCT00618618|3177736|Superiority or Other||LS Mean Difference|0.0|||<|0.863|2-Sided|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8|
1725353|NCT00618618|3177736|Superiority or Other||LS Mean Difference|-0.2|||<|0.29|2-Sided|95.0|-0.7|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8|
1725354|NCT00618618|3177736|Superiority or Other||LS Mean Difference|-0.2|||<|0.402|2-Sided|95.0|-0.5|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8|
1725355|NCT00618618|3177736|Superiority or Other||LS Mean Difference|0.3|||<|0.19|2-Sided|95.0|-0.1|0.7|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4|
1725356|NCT00618618|3177736|Superiority or Other||LS Mean Difference|-0.2|||<|0.286|2-Sided|95.0|-0.7|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4|
1725357|NCT00618618|3177736|Superiority or Other||LS Mean Difference|0.0|||<|0.934|2-Sided|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4|
1725358|NCT00618618|3177737|Superiority or Other||LS Mean Difference|0.1||||0.724|2-Sided|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24|
1725359|NCT00618618|3177737|Superiority or Other||LS Mean Difference|-0.2||||0.444|2-Sided|95.0|-0.6|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24|
1725360|NCT00618618|3177737|Superiority or Other||LS mean Difference|0.0||||0.852|2-Sided|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 24|
1725361|NCT00618618|3177737|Superiority or Other||LS Mean Difference|0.1||||0.795|2-Sided|95.0|-0.4|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16|
1725362|NCT00618618|3177737|Superiority or Other||LS Mean Difference|-0.1||||0.777|2-Sided|95.0|-0.5|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16|
1725363|NCT00618618|3177737|Superiority or Other||LS Mean Difference|0.0||||0.838|2-Sided|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 16|
1725364|NCT00618618|3177737|Superiority or Other||LS Mean Difference|0.0||||0.934|2-Sided|95.0|-0.4|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12|
1725365|NCT00618618|3177737|Superiority or Other||LS Mean Difference|0.0||||0.882|2-Sided|95.0|-0.4|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12|
1725366|NCT00618618|3177737|Superiority or Other||LS Mean Difference|0.1||||0.542|2-Sided|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 12|
1725367|NCT00618618|3177737|Superiority or Other||LS Mean Difference|0.1||||0.733|2-Sided|95.0|-0.3|0.5|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8|
1725368|NCT00618618|3177737|Superiority or Other||LS Mean Difference|0.2||||0.41|2-Sided|95.0|-0.3|0.6|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8|
1725369|NCT00618618|3177737|Superiority or Other||LS Mean Difference|-0.1||||0.791|2-Sided|95.0|-0.5|0.3|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 8|
1725370|NCT00618618|3177737|Superiority or Other||LS Mean Difference|-0.2||||0.404|2-Sided|95.0|-0.6|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4|
1725371|NCT00618618|3177737|Superiority or Other||LS Mean Difference|0.0||||0.906|2-Sided|95.0|-0.5|0.4|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4|
1725372|NCT00618618|3177737|Superiority or Other||LS Mean Difference|-0.1||||0.46|2-Sided|95.0|-0.5|0.2|||Repeated Measures|Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.||Week 4|
1725373|NCT00618618|3177738|Superiority or Other||Difference from Placebo|24.3||||0.296|2-Sided|95.0|-8.7|57.3|||Fisher Exact||||
1725374|NCT00618618|3177738|Superiority or Other||Difference from Placebo|54.3||||0.013|2-Sided|95.0|23.0|85.5|||Fisher Exact||||
1725375|NCT00618618|3177738|Superiority or Other||Difference from Placebo|46.1||||0.011|2-Sided|95.0|16.3|75.9|||Fisher Exact||||
1725376|NCT00618618|3177739|Superiority or Other||Difference from Placebo|22.9||||0.252|2-Sided|95.0|-8.4|54.2|||Fisher Exact||||
1725377|NCT00618618|3177739|Superiority or Other||Difference from Placebo|32.9||||0.172|2-Sided|95.0|1.0|64.8|||Fisher Exact||||
1725378|NCT00618618|3177739|Superiority or Other||Difference from Placebo|38.3||||0.008|2-Sided|95.0|11.0|65.7|||Fisher Exact||||
1725379|NCT00618618|3177740|Superiority or Other||LS Mean Difference|1.0||||0.122|2-Sided|95.0|-0.3|2.2|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.|||
1725380|NCT00618618|3177740|Superiority or Other||LS Mean Difference|2.5||||0.001|2-Sided|95.0|1.0|4.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.|||
1725381|NCT00618618|3177740|Superiority or Other||LS Mean Difference|1.8||||0.005|2-Sided|95.0|0.6|3.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.|||
1725382|NCT00618618|3177741|Superiority or Other||LS Mean Difference|-0.4||||0.069|2-Sided|95.0|-0.8|0.0|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.|||
1725383|NCT00618618|3177741|Superiority or Other||LS Mean Difference|-0.9||||0.001|2-Sided|95.0|-1.4|-0.4|||ANCOVA|Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.|||
1725384|NCT00618618|3177741|Superiority or Other||LS Mean Difference|-0.6||||0.005|2-Sided|95.0|-1.0|-0.2|||ANCOVA|Based on an analysis of covariance (ANCOVA) model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.|||
1725385|NCT00618332|3177771|Superiority or Other|||||||0.968|||||||t-test, 2 sided||||
1725386|NCT00618332|3177772|Superiority or Other|||||||0.8|||||||t-test, 2 sided||||
1725387|NCT00618332|3177773|Superiority or Other|||||||0.638|||||||t-test, 2 sided||||
1725388|NCT00618332|3177774|Superiority or Other|||||||0.795|||||||t-test, 2 sided||||
1725389|NCT00618332|3177775|Superiority or Other|||||||0.676|||||||t-test, 2 sided||||
1725390|NCT00618332|3177776|Superiority or Other|||||||0.117|||||||t-test, 2 sided||||
1725391|NCT00618332|3177777|Superiority or Other|||||||0.737|||||||t-test, 2 sided||||
1725392|NCT00618332|3177778|Superiority or Other|||||||0.775|||||||t-test, 2 sided||||
1725393|NCT00618332|3177779|Superiority or Other|||||||0.372|||||||t-test, 2 sided||||
1725394|NCT00618072|3177780|Superiority or Other||||||<|0.001|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725395|NCT00618072|3177780|Superiority or Other||||||<|0.73|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725396|NCT00618072|3177780|Superiority or Other||||||<|0.092|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725397|NCT00618072|3177781|Superiority or Other|||||||0.054|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725398|NCT00618072|3177781|Superiority or Other|||||||0.094|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725399|NCT00618072|3177781|Superiority or Other|||||||0.648|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725400|NCT00618072|3177782|Superiority or Other|||||||0.15|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725401|NCT00618072|3177782|Superiority or Other|||||||0.03|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725402|NCT00618072|3177782|Superiority or Other|||||||0.016|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725403|NCT00618072|3177783|Superiority or Other|||||||0.562|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725404|NCT00618072|3177783|Superiority or Other|||||||0.162|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725405|NCT00618072|3177783|Superiority or Other|||||||0.025|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725406|NCT00618072|3177784|Superiority or Other|||||||0.389|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725407|NCT00618072|3177784|Superiority or Other|||||||0.001|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725408|NCT00618072|3177784|Superiority or Other|||||||0.265|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725409|NCT00618072|3177785|Superiority or Other|||||||0.005|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725410|NCT00618072|3177785|Superiority or Other|||||||0.143|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725411|NCT00618072|3177785|Superiority or Other|||||||0.052|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725412|NCT00618072|3177786|Superiority or Other|||||||0.013|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725413|NCT00618072|3177786|Superiority or Other|||||||0.054|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725414|NCT00618072|3177786|Superiority or Other|||||||0.142|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725415|NCT00618072|3177787|Superiority or Other|||||||0.032|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725416|NCT00618072|3177787|Superiority or Other|||||||0.002|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725417|NCT00618072|3177787|Superiority or Other|||||||0.049|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725418|NCT00618072|3177788|Superiority or Other|||||||0.063|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725419|NCT00618072|3177788|Superiority or Other|||||||0.026|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725420|NCT00618072|3177788|Superiority or Other|||||||0.181|||||||Paired t-test|||Paired t-tests were used to compare within-group mean differences at baseline and at 6 months following randomization for each of the 3 comparator groups.|
1725421|NCT00617851|3177839|Non-Inferiority or Equivalence|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.09|||||2-Sided|95.0|0.94|1.26|||||"The control vaccine arm (n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).|
1725422|NCT00617851|3177839|Non-Inferiority or Equivalence|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.15|||||2-Sided|95.0|0.99|1.33|||||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).|
1725469|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.3|Standard Deviation|0.64||||||||||||Mean change from Baseline to Week 12 (LOCF)|
1725470|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.1|Standard Deviation|1.07||||||||||||Mean change from Baseline to Week 12 (LOCF)|
1725471|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.3|Standard Deviation|0.63||||||||||||Mean change from Baseline to Week 12 (LOCF)|
1725472|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.2|Standard Deviation|0.28||||||||||||Mean change from Baseline to Week 4 (LOCF)|
1725473|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.4|Standard Deviation|0.49||||||||||||Mean change from Baseline to Week 4 (LOCF)|
1725423|NCT00617851|3177839|Non-Inferiority or Equivalence|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited.|Ratio of GMTs (B strain)|1.06|||||2-Sided|95.0|0.91|1.23|||||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).|
1725424|NCT00617851|3177839|Non-Inferiority or Equivalence|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 strain)|0.87|||||2-Sided|95.0|0.76|1.01|||||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).|
1725425|NCT00617851|3177839|Non-Inferiority or Equivalence|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 strain)|0.98|||||2-Sided|95.0|0.85|1.13|||||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotC versus H13 LotA = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).|
1725426|NCT00617851|3177839|Non-Inferiority or Equivalence|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited.|Ratio of GMTs (A/H3N2 Strain)|1.12|||||2-Sided|95.0|0.97|1.3|||||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotA ≠ LotB versus H13 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).|
1725427|NCT00617851|3177839|Non-Inferiority or Equivalence|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.01|||||2-Sided|95.0|0.85|1.2|||||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H03 LotB ≠ LotC versus H13 LotB = LotC H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).|
1725428|NCT00617851|3177839|Non-Inferiority or Equivalence|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.1|||||2-Sided|95.0|0.93|1.31|||||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H02 LotA ≠ LotC versus H12 LotA = Lotc H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% CI on the GMT ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).|
1725474|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.2|Standard Deviation|0.28||||||||||||Mean change from Baseline to Week 4 (LOCF)|
1725475|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.4|Standard Deviation|0.5||||||||||||Mean change from Baseline to Week 4 (LOCF)|
1725476|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-0.6|Standard Deviation|5.94|||2-Sided|95.0|-8.0|6.8||||||Mean change from Baseline to Week 48 (LOCF)|
1725477|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-0.4|Standard Deviation|6.28|||2-Sided|95.0|-2.7|1.9||||||Mean change from Baseline to Week 48 (LOCF)|
1725429|NCT00617851|3177839|Non-Inferiority or Equivalence|The GMTs and 95% CIs and median, min and max values were calculated for each vaccine group and for each strain by exponentiating (base 10) the least square means of the log transformed (base 10) titers and their 95% CIs obtained from a two-way ANOVA with factors for vaccine group. The overall power is 80.56%, and thus each single test (# of comparisons=9) is performed with a power of 97.62% assuming independency. To account for dropouts, >= 428 subjects per lot was recruited.|Ratio of GMTs (A/H1N1 Strain)|1.09|||||2-Sided|95.0|0.92|1.29|||||"The control vaccine arm (Comparator, n=216) is included primarily to provide a comparative assessment for safety rather than for immunogenicity.~Sample size calculations were done by means of Nquery Advisor 5.0."|H01 LotA ≠ LotB versus H1 LotA = LotB H0 refers to the null hypothesis of non-equivalence (inconsistency) in that the two-sided 95% confidence interval (CI) on the geometric mean titer (GMT) ratio is outside the equivalence range (0.67 to 1.5). H1 refers to the alternative hypothesis of equivalence (consistency) in that the two-sided 95% CI on the GMT ratio is within the equivalence range (0.67 to 1.5).|
1725430|NCT00617734|3177855|Superiority or Other|||||||0.7455|||||||Log Rank||||
1725431|NCT00617734|3177857|Superiority or Other|||||||0.1935|||||||Fisher Exact||||
1725432|NCT00617734|3177858|Superiority or Other|||||||0.0667|||||||Log Rank||||
1725433|NCT00617604|3177873|Superiority or Other||Difference|5.2|||||2-Sided|90.0|-4.4|14.7|||||||
1725434|NCT00617604|3177874|Superiority or Other||Difference|-4.5|||||2-Sided|90.0|-11.2|2.2|||||||
1725435|NCT00617604|3177875|Superiority or Other||Slope|6.0|||||2-Sided|90.0|-2.7|14.6|||||||
1725436|NCT00617604|3177880|Superiority or Other||Difference|2.0|||||2-Sided|90.0|-3.3|7.2|||||||
1725437|NCT00617604|3177882|Superiority or Other||Difference|4.6|||||2-Sided|90.0|-1.2|10.4|||||||
1725438|NCT00617604|3177883|Superiority or Other||Difference|1.9|||||2-Sided|90.0|-1.3|5.0|||||||
1725439|NCT00617604|3177884|Superiority or Other||Difference|-1.8|||||2-Sided|90.0|-8.2|4.6|||||||
1725440|NCT00617604|3177885|Superiority or Other||Difference|-1.9|||||2-Sided|90.0|-7.6|3.8|||||||
1725441|NCT00617604|3177886|Superiority or Other||Difference|-9.4|||||2-Sided|90.0|-18.5|0.0|||||||
1725442|NCT00617604|3177887|Superiority or Other||Difference|-5.1|||||2-Sided|90.0|-14.9|4.7|||||||
1725443|NCT00617604|3177888|Superiority or Other||Difference|1.0|||||2-Sided|90.0|-0.6|2.5|||||||
1725444|NCT00617604|3177889|Superiority or Other||Difference|3.0|||||2-Sided|90.0|-4.0|10.1|||||||
1725445|NCT00617604|3177890|Superiority or Other||Difference|1.0|||||2-Sided|90.0|-3.1|5.0|||||||
1725446|NCT00617604|3177891|Superiority or Other||Difference|3.9|||||2-Sided|90.0|-2.5|10.3|||||||
1725447|NCT00617461|3177919|Superiority or Other||Adjusted mean difference versus placebo|-0.29||||0.013|2-Sided|90.0|-0.48|-0.1|||ANCOVA|An ANCOVA (repeated measures mixed model) with body mass index, baseline 24-hr average pain intensity, and grouped center as covariates was used.|||
1725448|NCT00617344|3177936|Other|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|31.4|||||2-Sided|95.0|18.2|43.2||||||Dengue Virus Serotype 4: 30 days post-injection 2|
1725449|NCT00617344|3177936|Other|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-4.0|||||2-Sided|95.0|-10.9|2.49||||||Dengue Virus Serotype 4: Pre-injection 1 (Day 0)|
1725450|NCT00617344|3177936|Other|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-5.7|||||2-Sided|95.0|-15.6|3.81||||||Dengue Virus Serotype 3: 30 days post-injection 2|
1725451|NCT00617344|3177936|Other|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|1.0|||||2-Sided|95.0|-9.09|11.1||||||Dengue Virus Serotype 3: Pre-injection 1 (Day 0)|
1725452|NCT00617344|3177936|Other|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-3.1|||||2-Sided|95.0|-15.0|8.75||||||Dengue Virus Serotype 2: 30 days post-injection 2|
1725453|NCT00617344|3177936|Other|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-2.0|||||2-Sided|95.0|-7.44|2.84||||||Dengue Virus Serotype 2: Pre-injection 1 (Day 0)|
1725454|NCT00617344|3177936|Other|The associated 95% CIs for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-15.5|||||2-Sided|95.0|-28.4|-2.0||||||Dengue Virus Serotype 1: 30 days post-injection 2|
1725455|NCT00617344|3177936|Other|The associated 95% confidence intervals (CIs) for the point estimates and the differences were calculated using normal approximation.|Difference in Percentage|-2.0|||||2-Sided|95.0|-7.44|2.84||||||Dengue Virus Serotype 1: Pre-injection 1 (Day 0)|
1725456|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.3|Standard Deviation|0.77||||||||||||Mean change from Baseline to Week 48 (LOCF)|
1725457|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.4|Standard Deviation|0.88||||||||||||Mean change from Baseline to Week 48 (LOCF)|
1725458|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.3|Standard Deviation|0.77||||||||||||Mean change from Baseline to Week 48 (LOCF)|
1725459|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.4|Standard Deviation|0.91||||||||||||Mean change from Baseline to Week 48 (LOCF)|
1725460|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.8|Standard Deviation|0.9||||||||||||Mean change from Baseline to Week 36 (LOCF)|
1725461|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.4|Standard Deviation|0.91||||||||||||Mean change from Baseline to Week 36 (LOCF)|
1725462|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.8|Standard Deviation|0.9||||||||||||Mean change from Baseline to Week 36 (LOCF)|
1725463|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.4|Standard Deviation|0.92||||||||||||Mean change from Baseline to Week 36 (LOCF)|
1725464|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.7|Standard Deviation|0.34||||||||||||Mean change from Baseline to Week 24 (LOCF)|
1725465|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.4|Standard Deviation|0.81||||||||||||Mean change from Baseline to Week 24 (LOCF)|
1725466|NCT00617305|3177939|Superiority or Other||Mean Difference (Net)|-0.7|Standard Deviation|0.34||||||||||||Mean change from Baseline to Week 24 (LOCF)|
1725480|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-0.4|Standard Deviation|6.33|||2-Sided|95.0|-2.8|2.1||||||Mean change from Baseline to Week 48 (LOCF)|
1725481|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-0.8|Standard Deviation|4.02|||2-Sided|95.0|-5.8|4.2||||||Mean change from Baseline to Week 36 (LOCF)|
1725482|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-0.3|Standard Deviation|5.07|||2-Sided|95.0|-2.2|1.5||||||Mean change from Baseline to Week 36 (LOCF)|
1725483|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-1.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)|
1725484|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-0.8|Standard Deviation|4.65|||2-Sided|95.0|-8.1|6.6||||||Mean change from Baseline to Week 36 (LOCF)|
1725485|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-0.3|Standard Deviation|5.2|||2-Sided|95.0|-2.3|1.7||||||Mean change from Baseline to Week 36 (LOCF)|
1725486|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-1.4|Standard Deviation|3.51|||2-Sided|95.0|-5.8|3.0||||||Mean change from Baseline to Week 24 (LOCF)|
1725487|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-0.9|Standard Deviation|4.84|||2-Sided|95.0|-2.6|0.9||||||Mean change from Baseline to Week 24 (LOCF)|
1725488|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-2.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)|
1725489|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-1.3|Standard Deviation|4.03|||2-Sided|95.0|-7.7|5.2||||||Mean change from Baseline to Week 24 (LOCF)|
1725490|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-0.8|Standard Deviation|5.0|||2-Sided|95.0|-2.7|1.1||||||Mean change from Baseline to Week 24 (LOCF)|
1725491|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|0.6|Standard Deviation|4.45|||2-Sided|95.0|-4.9|6.1||||||Mean change from Baseline to Week 12 (LOCF)|
1725492|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-0.8|Standard Deviation|4.09|||2-Sided|95.0|-2.3|0.6||||||Mean change from Baseline to Week 12 (LOCF)|
1725493|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-2.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)|
1725494|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|1.3|Standard Deviation|4.86|||2-Sided|95.0|-6.5|9.0||||||Mean change from Baseline to Week 12 (LOCF)|
1725495|NCT00617305|3177941|Superiority or Other||Mean Difference (Net)|-1.1|Standard Deviation|3.98|||2-Sided|95.0|-2.7|0.4||||||Mean change from Baseline to Week 12 (LOCF)|
1725496|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|0.8|Standard Deviation|3.03|||2-Sided|95.0|-3.0|4.6||||||Mean change from Baseline to Week 48 (LOCF)|
1725497|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|-0.5|Standard Deviation|2.3|||2-Sided|95.0|-1.3|0.3||||||Mean change from Baseline to Week 48 (LOCF)|
1725498|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|0.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)|
1725499|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|1.0|Standard Deviation|3.46|||2-Sided|95.0|-4.5|6.5||||||Mean change from Baseline to Week 48 (LOCF)|
1725500|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|-0.7|Standard Deviation|2.12|||2-Sided|95.0|-1.4|0.1||||||Mean change from Baseline to Week 48 (LOCF)|
1725501|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|0.8|Standard Deviation|1.79|||2-Sided|95.0|-1.4|3.0||||||Mean change from Baseline to Week 36 (LOCF)|
1725502|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|-0.4|Standard Deviation|1.85|||2-Sided|95.0|-1.0|0.2||||||Mean change from Baseline to Week 36 (LOCF)|
1725503|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|0.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)|
1725504|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|1.0|Standard Deviation|2.0|||2-Sided|95.0|-2.2|4.2||||||Mean change from Baseline to Week 36 (LOCF)|
1725505|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|-0.6|Standard Deviation|1.79|||2-Sided|95.0|-1.2|0.1||||||Mean change from Baseline to Week 36 (LOCF)|
1725506|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|-0.5|Standard Deviation|0.71|||2-Sided|95.0|-1.4|0.4||||||Mean change from Baseline to Week 24 (LOCF)|
1725507|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|-0.8|Standard Deviation|1.72|||2-Sided|95.0|-1.4|-0.3||||||Mean change from Baseline to Week 24 (LOCF)|
1725508|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|0.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)|
1725509|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|-0.6|Standard Deviation|0.75|||2-Sided|95.0|-1.8|0.6||||||Mean change from Baseline to Week 24 (LOCF)|
1725510|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|-0.9|Standard Deviation|1.81|||2-Sided|95.0|-1.5|-0.2||||||Mean change from Baseline to Week 24 (LOCF)|
1725511|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|1.2|Standard Deviation|2.17|||2-Sided|95.0|-1.5|3.9||||||Mean change from Baseline to Week 12 (LOCF)|
1725512|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|-0.3|Standard Deviation|1.67|||2-Sided|95.0|-0.9|0.2||||||Mean change from Baseline to Week 12 (LOCF)|
1725513|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|0.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)|
1725514|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|1.5|Standard Deviation|2.38|||2-Sided|95.0|-2.3|5.3||||||Mean change from Baseline to Week 12 (LOCF)|
1725515|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|-0.6|Standard Deviation|1.45|||2-Sided|95.0|-1.1|0.0||||||Mean change from Baseline to Week 12 (LOCF)|
1725516|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|0.4|Standard Deviation|1.52|||2-Sided|95.0|-1.5|2.3||||||Mean change from Baseline to Week 4 (LOCF)|
1725517|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|-0.4|Standard Deviation|1.54|||2-Sided|95.0|-0.9|0.1||||||Mean change from Baseline to Week 4 (LOCF)|
1725518|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|-1.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 4 (LOCF)|
1725636|NCT00614393|3178318|Superiority or Other||Hazard Ratio (HR)|1.41||||0.06|2-Sided|95.0|0.99|2.0|||Regression, Cox||||
1725519|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|0.8|Standard Deviation|1.5|||2-Sided|95.0|-1.6|3.1||||||Mean change from Baseline to Week 4 (LOCF)|
1725520|NCT00617305|3177942|Superiority or Other||Mean Difference (Net)|-0.5|Standard Deviation|1.5|||2-Sided|95.0|-1.1|0.0||||||Mean change from Baseline to Week 4 (LOCF)|
1725521|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|-26.4|Standard Deviation|121.55|||2-Sided|95.0|-177.3|124.5||||||Mean change from Baseline to Week 48 (LOCF)|
1725522|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|7.4|Standard Deviation|88.11|||2-Sided|95.0|-22.4|37.3||||||Mean change from Baseline to Week 48 (LOCF)|
1725523|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|67.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 48 (LOCF)|
1725524|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|-49.8|Standard Deviation|126.75|||2-Sided|95.0|-251.4|151.9||||||Mean change from Baseline to Week 48 (LOCF)|
1725525|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|14.6|Standard Deviation|82.07|||2-Sided|95.0|-15.0|44.2||||||Mean change from Baseline to Week 48 (LOCF)|
1725526|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|-13.8|Standard Deviation|92.46|||2-Sided|95.0|-128.6|101.0||||||Mean change from Baseline to Week 36 (LOCF)|
1725527|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|-1.8|Standard Deviation|78.5|||2-Sided|95.0|-28.4|24.8||||||Mean change from Baseline to Week 36 (LOCF)|
1725528|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|67.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 36 (LOCF)|
1725529|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|-34.0|Standard Deviation|93.16|||2-Sided|95.0|-182.2|114.2||||||Mean change from Baseline to Week 36 (LOCF)|
1725530|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|2.2|Standard Deviation|77.24|||2-Sided|95.0|-25.6|30.1||||||Mean change from Baseline to Week 36 (LOCF)|
1725531|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|9.8|Standard Deviation|50.18|||2-Sided|95.0|-52.5|72.1||||||Mean change from Baseline to Week 24 (LOCF)|
1725532|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|15.0|Standard Deviation|47.44|||2-Sided|95.0|-1.0|31.1||||||Mean change from Baseline to Week 24 (LOCF)|
1725533|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|87.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 24 (LOCF)|
1725534|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|-9.5|Standard Deviation|29.56|||2-Sided|95.0|-56.5|37.5||||||Mean change from Baseline to Week 24 (LOCF)|
1725535|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|18.1|Standard Deviation|48.67|||2-Sided|95.0|0.5|35.6||||||Mean change from Baseline to Week 24 (LOCF)|
1725536|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|19.4|Standard Deviation|63.61|||2-Sided|95.0|-59.6|98.4||||||Mean change from Baseline to Week 12 (LOCF)|
1725537|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|12.4|Standard Deviation|42.83|||2-Sided|95.0|-2.1|26.9||||||Mean change from Baseline to Week 12 (LOCF)|
1725538|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|87.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 12 (LOCF)|
1725539|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|2.5|Standard Deviation|59.09|||2-Sided|95.0|-91.5|96.5||||||Mean change from Baseline to Week 12 (LOCF)|
1725540|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|13.6|Standard Deviation|41.46|||2-Sided|95.0|-1.4|28.5||||||Mean change from Baseline to Week 12 (LOCF)|
1725541|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|27.6|Standard Deviation|48.03|||2-Sided|95.0|-32.0|87.2||||||Mean change from Baseline to Week 4 (LOCF)|
1725542|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|11.7|Standard Deviation|42.68|||2-Sided|95.0|-2.7|26.2||||||Mean change from Baseline to Week 4 (LOCF)|
1725543|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|107.0|Standard Deviation|0.0||||||||||||Mean change from Baseline to Week 4 (LOCF)|
1725544|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|7.8|Standard Deviation|21.19|||2-Sided|95.0|-26.0|41.5||||||Mean change from Baseline to Week 4 (LOCF)|
1725545|NCT00617305|3177943|Superiority or Other||Mean Difference (Net)|12.2|Standard Deviation|44.84|||2-Sided|95.0|-3.9|28.4||||||Mean change from Baseline to Week 4 (LOCF)|
1725546|NCT00617305|3177944|Superiority or Other||Mean Difference (Net)|0.33|Standard Deviation|0.685|||2-Sided|95.0|-0.77|1.42||||||Mean change from Baseline to Week 24|
1725547|NCT00617305|3177944|Superiority or Other||Mean Difference (Net)|0.78|Standard Deviation|1.021|||2-Sided|95.0|0.41|1.15||||||Mean change from Baseline to Week 24|
1725548|NCT00617305|3177944|Superiority or Other||Mean Difference (Net)|0.33|Standard Deviation|0.685|||2-Sided|95.0|-0.77|1.42||||||Mean change from Baseline to Week 24|
1725549|NCT00617305|3177944|Superiority or Other||Mean Difference (Net)|0.84|Standard Deviation|1.053|||2-Sided|95.0|0.43|1.25||||||Mean change from Baseline to Week 24|
1725550|NCT00617305|3177945|Superiority or Other||Mean Difference (Net)|-4.0|Standard Deviation|4.082|||2-Sided|95.0|-10.5|2.5||||||Mean change from Baseline to Week 24|
1725551|NCT00617305|3177945|Superiority or Other||Mean Difference (Net)|-0.51|Standard Deviation|4.527|||2-Sided|95.0|-2.07|1.04||||||Mean change from Baseline to Week 24|
1725552|NCT00617305|3177945|Superiority or Other||Mean Difference (Net)|-4.0|Standard Deviation|4.082|||2-Sided|95.0|-10.5|2.5||||||Mean change from Baseline to Week 24|
1725553|NCT00617305|3177945|Superiority or Other||Mean Difference (Net)|-0.06|Standard Deviation|4.442|||2-Sided|95.0|-1.69|1.56||||||Mean change from Baseline to Week 24|
1725554|NCT00617305|3177946|Superiority or Other||Mean Difference (Net)|-15.75|Standard Deviation|8.732|||2-Sided|95.0|-29.64|-1.86||||||Mean change from Baseline to Week 24|
1725555|NCT00617305|3177946|Superiority or Other||Mean Difference (Net)|-6.56|Standard Deviation|8.589|||2-Sided|95.0|-9.51|-3.61||||||Mean change from Baseline to Week 24|
1725556|NCT00617305|3177946|Superiority or Other||Mean Difference (Net)|-15.75|Standard Deviation|8.732|||2-Sided|95.0|-29.64|-1.86||||||Mean change from Baseline to Week 24|
1725557|NCT00617305|3177946|Superiority or Other||Mean Difference (Net)|-5.38|Standard Deviation|7.954|||2-Sided|95.0|-8.29|-2.46||||||Mean change from Baseline to Week 24|
1725637|NCT00614380|3178332|Superiority or Other||Odds Ratio (OR)|0.27||||||95.0|0.1|0.72|||||||
1725558|NCT00617305|3177947|Superiority or Other||Mean Difference (Net)|-291.8|Standard Deviation|205.864|||2-Sided|95.0|-619.4|35.78||||||Mean change from Baseline to Week 24|
1725559|NCT00617305|3177947|Superiority or Other||Mean Difference (Net)|-253.83|Standard Deviation|235.787|||2-Sided|95.0|-334.8|-172.8||||||Mean change from Baseline to Week 24|
1725560|NCT00617305|3177947|Superiority or Other||Mean Difference (Net)|-291.8|Standard Deviation|205.864|||2-Sided|95.0|-619.4|35.78||||||Mean change from Baseline to Week 24|
1725561|NCT00617305|3177947|Superiority or Other||Mean Difference (Net)|-248.93|Standard Deviation|241.978|||2-Sided|95.0|-337.7|-160.2||||||Mean change from Baseline to Week 24|
1725562|NCT00617175|3177989|Superiority or Other||||||<|0.001|||||||Negative binomial regression||||
1725563|NCT00617097|3177995|Superiority or Other|||||||0.15|||||||Chi-squared|||serious complications|
1725564|NCT00617097|3177995|Superiority or Other|||||||1|||||||Chi-squared|||minor complications greater number is worse (i.e., more complications)|
1725565|NCT00617097|3177996|Superiority or Other|||||||0.07|||||||Chi-squared|||greater number is worse (i.e., more symptoms)|
1725566|NCT00617097|3177997|Superiority or Other|||||||0.93|||||||Regression, Linear|||greater number is better (i.e., more satisfaction) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less satisfaction); maximum: 100 mm (greater satisfaction) Measured at end of study (i.e., upon clinic discharge)|
1725567|NCT00617097|3177998|Superiority or Other||Mean Difference (Final Values)|-4.1||||0.52|2-Sided|95.0|-17.0|8.8|||Regression, Linear|||30 min after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)|
1725568|NCT00617097|3177998|Superiority or Other||Mean Difference (Final Values)|0.7||||0.7|2-Sided|95.0|-12.2|18.0|||Regression, Linear|||immediately after procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)|
1725569|NCT00617097|3177998|Superiority or Other||Mean Difference (Final Values)|-15.0||||0.03|2-Sided|95.0|-28.3|-1.7|||Regression, Linear|||after cervical dilation greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)|
1725570|NCT00617097|3177998|Superiority or Other||Mean Difference (Final Values)|-4.8||||0.49|2-Sided|95.0|-18.6|9.0|||Regression, Linear|||during paracervical block administration greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)|
1725571|NCT00617097|3177998|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.9|2-Sided|95.0|-15.1|13.2|||Regression, Linear|||after speculum insertion greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)|
1725572|NCT00617097|3177998|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.94|2-Sided|95.0|-13.7|12.6|||Regression, Linear|||expected level of pain during procedure greater number is worse (i.e., more pain) 100-mm Visual Analogue Scale (VAS): minimum: 0 mm (less pain); maximum: 100 mm (more pain)|
1725573|NCT00616967|3178020|Superiority or Other (legacy)||Odds Ratio (OR)|5.1||||0.023|2-Sided|95.0|1.3|22.7|||Regression, Logistic|||The estimates provided are based upon a multivariate analysis using a logistic regression adjusting for hormone receptor status. Patients with ≥50% reduction in SULmax were more likely to achieve a pCR.|
1725574|NCT00616967|3178023|Superiority or Other (legacy)||pCR in vorinostat arm (arm 2)|0.258|||||2-Sided|95.0|0.119|0.446|||||||
1725575|NCT00616967|3178023|Superiority or Other (legacy)||pCR in placebo arm (arm 1)|0.29|||||2-Sided|95.0|0.142|0.48|||||||
1725576|NCT00616967|3178023|Superiority or Other (legacy)||Pathological complete response rate|0.274|||||2-Sided|95.0|0.169|0.402|||||The Estimation Parameter provided above is for overall pCR for both arms combined. We estimated pCR for each arm separately as well.|Patients were stratified by hormone receptor status and randomly assigned to either arm 1 or 2. This study was designed using Simon’s two-stage design for each arm in parallel. Interim analysis of early stopping for futility was conducted for the first 32 patients (16 patients per arm) and the study proceeded as more than 2 patients achieved a pCR in each arm (31 patients per arm). This design had 80% power to detect a 25% pCR rate versus a null rate of 10% with a type I error rate of 0.10.|
1725577|NCT00616772|3178054|Superiority or Other||Mean Difference (Final Values)|0.016||||0.112|2-Sided|95.0|-0.004|0.035|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate|||
1725578|NCT00616772|3178055|Superiority or Other||Mean Difference (Final Values)|-0.005||||0.487|2-Sided|95.0|-0.02|0.01|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate|||
1725579|NCT00616772|3178056|Superiority or Other||Mean Difference (Final Values)|-0.007||||0.249|2-Sided|95.0|-0.018|0.005|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline IMT as covariate|||
1725580|NCT00616772|3178057|Superiority or Other||Mean Difference (Final Values)|-0.002||||0.813|2-Sided|95.0|-0.014|0.011|||Repeated measures linear mixed model|Fixed effects for baseline atorvastatin dose, imaging site, treatment, time; interaction between treatment group and time; baseline cIMT as covariate.|||
1725581|NCT00616772|3178058|Superiority or Other||Mean Difference (Final Values)|-0.006||||0.22|2-Sided|95.0|-0.016|0.004|||Repeated measures linear mixed model|Fixed effects for baseline cIMT, baseline atorvastatin dose, central imaging site, treatment group, time; interaction between treatment group and time|||
1725582|NCT00616200|3178101|Superiority or Other|||||||0.001|||||||ANOVA|||Sickness Impact Profile scores improved.|
1725583|NCT00615550|3178149|Superiority or Other||Risk Ratio (RR)|0.83||||0.213|2-Sided|95.0|0.62|1.11|||Cochran-Mantel-Haenszel|||Statistical analysis for birth weight < 2500 grams data.|
1725584|NCT00615550|3178149|Superiority or Other||Risk Ratio (RR)|0.47||||0.01|2-Sided|95.0|0.26|0.85|||Cochran-Mantel-Haenszel|||Statistical analysis for birth weight < 1500 grams data.|
1725585|NCT00615550|3178150|Superiority or Other||Risk Ratio (RR)|0.57||||0.431|2-Sided|95.0|0.14|2.35|||Cochran-Mantel-Haenszel||||
1725586|NCT00615550|3178151|Superiority or Other||Risk Ratio (RR)|0.89||||0.376|2-Sided|95.0|0.68|1.16|||Cochran-Mantel-Haenszel|||Statistical analysis presented for <36 weeks data.|
1725587|NCT00615550|3178151|Superiority or Other||Risk Ratio (RR)|0.62||||0.016|2-Sided|95.0|0.42|0.92|||Cochran-Mantel-Haenszel|||Statistical analysis presented for <= 34 6/7 weeks data.|
1725588|NCT00615550|3178151|Superiority or Other||Risk Ratio (RR)|0.5||||0.036|2-Sided|95.0|0.25|0.97|||Cochran-Mantel-Haenszel|||Statistical analysis presented for births <=27 6/7 weeks data.|
1725589|NCT00615550|3178152|Superiority or Other||Risk Ratio (RR)|0.39||||0.026|2-Sided|95.0|0.17|0.92|||Cochran-Mantel-Haenszel|||Statistical analysis presented for RDS data.|
1725590|NCT00615550|3178152|Superiority or Other|||||||0.048|||||||Cochran-Mantel-Haenszel|||Statistical analysis presented for composite score data.|
1725591|NCT00615550|3178153|Superiority or Other||Risk Ratio (RR)|0.55||||0.02|2-Sided|95.0|0.33|0.92|||Cochran-Mantel-Haenszel||||
1725592|NCT00615433|3178157|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis||||
1725593|NCT00615433|3178158|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||Improvements in PANSS ratings are estimated from 2 prior studies of lurasidone. Assuming lurasidone differs from placebo in change from baseline in PANSS by 6.8 and 10.0 for 40 and 120 mg, respectively, and assuming a standard deviation of 19.1, then n=120 subjects per group provides approximately 97% power (at α=0.05, two-sided) to reject the null hypothesis of no difference from placebo for at least 1 dose. This calculation uses Bonferroni’s procedure for controlling pairwise differences.|
1725594|NCT00615264|3178170|Superiority or Other|||||||0.769|||||||Mixed Models Analysis|Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix|||
1725595|NCT00615264|3178171|Superiority or Other|||||||0.2851|||||||Mixed Models Analysis|Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix|||
1725596|NCT00615069|3178183|Superiority or Other||Hazard Ratio (HR)|1.241|||||2-Sided|95.0|0.428|3.603||||||Estimation of Hazard ratio of the 31 mm GORE EXCLUDER® Test Subjects vs original GORE EXCLUDER® AAA Endoprosthesis Subjects (original PMA subjects) using Cox Regression, not a powered analysis.|
1725597|NCT00615069|3178184|Superiority or Other|||||||0.003|||||||Log Rank|||Log-rank test of freedom from major adverse events through 1 year, 31 mm GORE EXCLUDER® Test Subjects vs historical open surgical control Subjects.|
1725598|NCT00615056|3178188|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.5235|2-Sided|95.0|-19.1|18.0|||Chi-squared|||One-sided Pearson chi square test at alpha = 0.15 significance level was used.|
1725599|NCT00615056|3178188|Superiority or Other||Mean Difference (Final Values)|1.0||||0.4552|2-Sided|95.0|-15.8|17.7|||Chi-squared|||One-sided Pearson chi square test at alpha = 0.15 significance level was used.|
1725600|NCT00615056|3178189|Superiority or Other||Hazard Ratio (HR)|0.689||||0.1159|2-Sided|95.0|0.373|1.273||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).|
1725601|NCT00615056|3178189|Superiority or Other||Hazard Ratio (HR)|1.355||||0.8828|2-Sided|95.0|0.82|2.238||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).|
1725602|NCT00615056|3178190|Superiority or Other||Hazard Ratio (HR)|1.041||||0.5498|2-Sided|95.0|0.553|1.041||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for ECOG performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).|
1725603|NCT00615056|3178190|Superiority or Other||Hazard Ratio (HR)|1.273||||0.8268|2-Sided|95.0|0.769|2.108||One-sided log-rank test at alpha = 0.15 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for Eastern Cooperative Oncology Group (ECOG) performance status (0 versus 1) and prior treatment with bevacizumab (yes versus no).|
1725604|NCT00614939|3178224|Superiority or Other||Mean Difference (Net)|-2.14|Standard Error of the Mean|2.985|||2-Sided|95.0|-8.04|3.76||||||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."|
1725605|NCT00614939|3178225|Superiority or Other||Mean Difference (Net)|-0.89|Standard Error of the Mean|1.405|||2-Sided|95.0|-3.66|1.89||||||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."|
1725606|NCT00614939|3178226|Superiority or Other||Mean Difference (Net)|-0.97|Standard Error of the Mean|1.027|||2-Sided|95.0|-2.99|1.04||||||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."|
1725607|NCT00614939|3178227|Superiority or Other||Mean Difference (Net)|-38.09|Standard Error of the Mean|53.822|||2-Sided|95.0|-144.44|68.26||||||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."|
1725608|NCT00614939|3178228|Superiority or Other||Mean Difference (Net)|-15.73|Standard Error of the Mean|25.326|||2-Sided|95.0|-65.77|34.3||||||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."|
1725609|NCT00614939|3178229|Superiority or Other||Mean Difference (Net)|-17.98|Standard Error of the Mean|18.475|||2-Sided|95.0|-54.28|18.33||||||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."|
1725610|NCT00614939|3178230|Superiority or Other||Mean Difference (Net)|-0.82|Standard Error of the Mean|0.228|||2-Sided|95.0|-1.27|-0.37|||||||
1725611|NCT00614939|3178231|Superiority or Other||Mean Difference (Net)|2.44|Standard Error of the Mean|1.709|||2-Sided|95.0|-1.05|5.93||||||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."|
1725612|NCT00614939|3178232|Superiority or Other||Mean Difference (Net)|-0.24|Standard Error of the Mean|0.941|||2-Sided|95.0|-2.14|1.67||||||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."|
1725613|NCT00614939|3178233|Superiority or Other||Mean Difference (Net)|-0.68|Standard Error of the Mean|0.713|||2-Sided|95.0|-2.1|0.74||||||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."|
1725614|NCT00614939|3178234|Superiority or Other||Mean Difference (Net)|44.01|Standard Error of the Mean|30.815||0.164|2-Sided|95.0|-18.93|106.94|||ANCOVA|*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."|
1725615|NCT00614939|3178235|Superiority or Other||Mean Difference (Net)|-4.36|Standard Error of the Mean|16.938||0.798|2-Sided|95.0|-38.65|29.93|||ANCOVA|*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."|
1725616|NCT00614939|3178236|Superiority or Other||Mean Difference (Net)|-12.34|Standard Error of the Mean|12.847||0.339||95.0|-37.91|13.22|||ANCOVA|*Adjusted for baseline FPG||"Additional details about the analysis, such as null hypothesis and power calculation:~Due to a statistically significant treatment-by-baseline renal impairment interaction, fasting plasma glucose results were analyzed separately for each baseline renal impairment category."|
1725617|NCT00614939|3178237|Superiority or Other||Mean Difference (Net)|-0.42|Standard Error of the Mean|0.151||0.007|2-Sided|95.0|-0.71|-0.12|||ANCOVA|*Adjusted for baseline HbA1c|||
1725618|NCT00614874|3178243|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Deviation|0.95||0.398||95.0||||Comparison was at baseline and week 12|Friedman||||
1725619|NCT00614874|3178244|Superiority or Other||Mean Difference (Final Values)|7.0|Standard Deviation|35.0||0.183||95.0||||comparison was at baseline and week 12|Friedman||||
1725620|NCT00614874|3178245|Superiority or Other|||||||0.048||||||Comparison is between baseline and week 12|ANOVA||||
1725621|NCT00614744|3178259|Superiority|This trial estimated the probability that the intervention has no effect on the outcome (or conversely, the probability that it does), given the data obtained in the trial and any prior evidence.|Risk Ratio (RR)|0.86|||||2-Sided|95.0|0.59|1.29|||||In log binomial models used Normal (0, sd=0.35) neutral prior in the log RR scale. Estimation used Normal weakly informative priors. Reported posterior medians & 95% credible intervals for the RR above instead of confidence intervals.|Whole-body Hypothermia vs. Normothermia (Normothermia is the comparison group)|"We fitted all Bayesian models via Markov chain Monte Carlo methods (MCMC) using JAGS (version 3.4) and OpenBUGS (3.2.3) in R (version 3.2.5). For each analysis we ran 3 MCMC chains with starting values randomly drawn from the estimated parameters from a frequentist log binomial model. A burn-in of 1,000 iterations was used, with sampling from a further 10,000 iterations for each chain. To monitor convergence, trace plots and the Gelman-Rubin convergence diagnostic (Rhat) were used for all parameters.~For all analyses, the trace plots show good mixing of the 3 chains with Rhat < 1.01 for all parameters, indicating convergence."
1725622|NCT00614575|3178291|Superiority or Other||mean change from baseline|-0.3|Standard Deviation|0.6|<|0.0001|||||||paired t-test||||
1725623|NCT00614575|3178292|Superiority or Other||Mean change from baseline|-0.7|Standard Deviation|0.9|<|0.0001|||||||paired t-test||||
1725624|NCT00614575|3178293|Superiority or Other||Mean change from baseline|-4.8|Standard Deviation|7.8|<|0.0001|||||||Paired t-test||||
1725625|NCT00614575|3178294|Superiority or Other||Mean change from baseline|-7.2|Standard Deviation|9.0|<|0.0001|||||||Paired t-test||||
1725626|NCT00614523|3178296|Superiority or Other (legacy)||Risk Ratio (RR)|0.639|||<|0.001|2-Sided|95.0|0.57|0.71|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo||
1725627|NCT00614523|3178300|Superiority or Other (legacy)||Risk Ratio (RR)|1.402||||0.032|2-Sided|95.0|1.03|1.91|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo||
1725628|NCT00614523|3178301|Superiority or Other (legacy)||Odds Ratio (OR)|15.6|||<|0.001|2-Sided|95.0|4.7|51.8|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for stratification factors.|Romiplostim /Placebo||
1725629|NCT00614523|3178302|Superiority or Other (legacy)||Risk Ratio (RR)|0.739|||<|0.001|2-Sided|95.0|0.68|0.8|||Poisson Regression model|Poisson regression model with treatment and stratification factors as covariates|Romiplostim /Placebo||
1725630|NCT00614523|3178303|Superiority or Other (legacy)||Risk Ratio (RR)|0.922||||0.026|2-Sided|95.0|0.86|0.99|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates.|Romiplostim /Placebo||
1725631|NCT00614523|3178304|Superiority or Other (legacy)||Risk Ratio (RR)|0.766|||<|0.001|2-Sided|95.0|0.66|0.88|||Poisson regression model|Poisson regression model with treatment and stratification factors as covariates.|Romiplostim /Placebo||
1725632|NCT00614523|3178305|Superiority or Other (legacy)||Hazard Ratio (HR)|0.83||||0.13|2-Sided|95.0|0.66|1.05|||Anderson-Gill model|Anderson-Gill model using the model-based variance estimate and stratified by the randomization stratification factors|Romiplostim /Placebo||
1725633|NCT00614393|3178317|Superiority or Other||Hazard Ratio (HR)|1.13||||0.44|2-Sided|95.0|0.83|1.55|||Regression, Cox||||
1725634|NCT00614393|3178317|Superiority or Other||Hazard Ratio (HR)|1.33||||0.07|2-Sided|95.0|0.98|1.83|||Regression, Cox||||
1725635|NCT00614393|3178318|Superiority or Other||Hazard Ratio (HR)|1.26||||0.18|2-Sided|95.0|0.89|1.79|||Regression, Cox||||
1725643|NCT00614198|3178336|Superiority or Other||||||<|0.01||||||A priori p threshold set for stage 1 (baseline - 8m; p<0.01) or (baseline - 12 months, p<0.05) in order to progress to stage 2 (8 or 12 months - 20 or 24 months).|Mixed Models Analysis|||1st stage analysis (baseline-8m or 12m) used a repeated measures model for all assessment measures. Model included baseline, age, time and time*treatment interaction. Results informed 2nd stage (8 or 12 months - 20 or 24 months). 2nd stage analysis based on various statistical scenarios (baseline vs 12 months on intervention, 12 months of no intervention vs 12 on intervention, baseline vs 24 months on intervention). No ADOS assessments were used at 12 months because of risk of practice effects.|
1725644|NCT00614120|3178344|Non-Inferiority or Equivalence|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 0.6mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|0.25||||0.0421||95.0|0.08|0.42||In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."|
1725645|NCT00614120|3178344|Non-Inferiority or Equivalence|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.2mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|0.03|||<|0.0001||95.0|-0.14|0.2||In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."|
1725646|NCT00614120|3178344|Non-Inferiority or Equivalence|Non-inferiority is concluded if the two-sided upper limit of the 95% confidence interval for treatment difference in mean change in HbA1c between lira 1.8mg + met and glim + met is below 0.4%.|Estimated treatment difference, LS Mean|-0.06|||<|0.0001||95.0|-0.23|0.11||Non-inferiority; <.0001. In order to protect the overall Type I error rate when testing for non-inferiority of the three doses of lira + met to glim + met, the comparisons will be invoked sequentially for descending doses of liraglutide.|ANCOVA|ANCOVA model with treatment, country and previous treatment as fixed effects and baseline value as a covariate.|The p-values correspond to one-sided hypotheses of either superiority or non-inferiority. Statistical significance on a 2.5% level.|"Based on standard normal theory, the sample size needed in order to be able to show that lira + met is non-inferior to glim + met when using a 1:1 randomisation and a non-inferiority criteria of 0.4% with a power of at least 85%, is tabulated below using different SD of HbA1c.~Assuming a drop out rate of 25%, the total number of subjects to be randomised is 896 (224 for each dose of the liraglutide + metformin group and 224 subjects in metformin+glimepiride treatment group) with a SD of 1.2%."|
1725647|NCT00613938|3178375|Superiority or Other||Mean Difference (Final Values)|62.4|Standard Error of the Mean|11.9|<|0.001||95.0|39.01|85.73||Comparisons of tapentadol dose groups and placebo was performed with Hochberg procedure for adjustment for the multiple tests.|ANCOVA||The results shown are the treatment group differences between Tapentadol IR 50mg group and placebo.|Null hypothesis: There are no differences in pain intensity measured by SPID-48 hours between any of tapentadol dose groups and placebo. ANCOVA model with factors of treatment, center and baseline pain intensity score was used for the primary analysis.|
1725648|NCT00613626|3178385|Superiority or Other (legacy)||Logistic Regression Analysis|0.05|||||2-Sided|95.0|||||||Objective Response Analysis of VEGF variants using Logistic Regression Analysis in arm A and arm B||
1725649|NCT00613626|3178385|Superiority or Other (legacy)||Cox Proportional Hazard|0.05|||||2-Sided|95.0|||||||Survival analysis of VEGF variants using cox proportional hazard analysis in arm A and arm B.|Data was not collected for safety lead-in participants and these participants were not included in the analysis.|
1725650|NCT00613626|3178386|Superiority or Other (legacy)|||||||0.4577|||||||Log Rank||||
1725651|NCT00613626|3178387|Superiority or Other (legacy)|||||||0.872|||||||Difference in Rates||||
1725652|NCT00613626|3178388|Superiority or Other (legacy)|||||||0.2533|||||||Difference in Rates|P-value (two-tailed) is calculated based on an unadjusted, normal-distribution approximation for the difference in rates.|||
1725653|NCT00613626|3178390|Superiority or Other (legacy)|||||||0.9518||||||P-Value (2-tailed) is calculated based on the unstratified log-rank test.|Log Rank|Degrees of freedom=1|||
1725654|NCT00613626|3178390|Superiority or Other (legacy)||Median Difference (Final Values)|3.0|Standard Error of the Mean|22.718||0.1|1-Sided|90.0|||||Log Rank|||A one-sided log rank test with an overall sample size of 68 subjects (of which 34 are in arm A and 34 are in arm B) achieves 80% power at a 0.10 significance level to detect a difference of 3 months in PFS between 4 month median PFS and 7 month median PFS.|
1725655|NCT00613509|3178400|Superiority or Other|||||||0.9179|||||||Likelihood ratio test||||
1725656|NCT00613509|3178400|Superiority or Other|||||||0.9406|||||||Log Rank||||
1725657|NCT00613106|3178439|Superiority or Other|||||||0.4228|||||||Cochran-Mantel-Haenszel||||
1725658|NCT00613080|3178448|Superiority or Other||Proportion (reported as percentage)|51.0||||0.93|2-Sided||||||Chi-squared|||This study was designed for a one-sided chi-square test to detect at least 12% reduction in the 40% rate of ≥ grade 2 treatment-related preoperative GI AEs from the conventional radiotherapy / capecitabine /oxaliplatin arm of study RTOG-0247 (NCT00081289) with 80% power and a one-sided type I error rate of 0.10.|
1725659|NCT00612807|3178464|Non-Inferiority or Equivalence|Testing whether means at each timepoint varied by identified patient status and treatment condition.|Interaction term|-12.97|Standard Error of the Mean|4.52||0.005||95.0||||We probed this interaction and discovered that at each assessment, spouses in the couple therapy + medication treatment group reported greater dyadic adjustment than did spouses in the medication alone condition (b = 10.53, z = 2.72, p = 0.006).|Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants’ baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.|
1725660|NCT00612807|3178464|Non-Inferiority or Equivalence|Testing whether slope of change over time varied by identified patient status and treatment condition.|Interaction term|0.64|Standard Error of the Mean|0.65||0.32||95.0|||||Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants’ baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.|
1725661|NCT00612807|3178465|Non-Inferiority or Equivalence|Testing whether slope of change over time varied by identified patient status and treatment condition.|Interaction term|-0.56|Standard Error of the Mean|0.29||0.056||95.0||||Interaction indicates that slope of change varied by identified patient status and tx condition. Slope of change in depression was significantly negative for everyone but identified patients in the control condition.|Fixed effect in multi-level model|||Utilized a hierarchical linear model with time nested within individual and individual nested within couple. Given the small sample size, we chose to include participants’ baseline depression scores as a covariate, and model the trajectory of change in depression scores beginning with the second assessment, which occurred one month into the study. Additional fixed effect predictors included status as identified patient or spouse, treatment condition, time, and all possible interactions.|
1725662|NCT00612573|3178475|Superiority or Other|||||||0.081|||||||Cochran-Mantel-Haenszel|Stratified by Investigational Site|||
1725663|NCT00612573|3178475|Superiority or Other|||||||0.231|||||||Cochran-Mantel-Haenszel|Stratified by Investigational Site|||
1725664|NCT00612573|3178475|Superiority or Other|||||||0.276|||||||Cochran-Mantel-Haenszel|Stratified by Investigational Site|||
1725665|NCT00612573|3178476|Superiority or Other|||||||0.399|||||||Cochran-Mantel-Haenszel|Stratified by Investigational Site|||
1725666|NCT00612573|3178476|Superiority or Other|||||||0.505|||||||Cochran-Mantel-Haenszel|Stratified by Investigational Site|||
1725667|NCT00612573|3178476|Superiority or Other|||||||0.212|||||||Cochran-Mantel-Haenszel|Stratified by Investigational Site|||
1725668|NCT00612573|3178477|Superiority or Other|||||||0.039|||||||Cochran-Mantel-Haenszel|Stratified by Investigational Site|||
1725669|NCT00612573|3178477|Superiority or Other|||||||0.075|||||||Cochran-Mantel-Haenszel|Stratified by Investigational Site|||
1725670|NCT00612573|3178477|Superiority or Other|||||||0.807|||||||Cochran-Mantel-Haenszel|Stratified by Investigational Site|||
1725671|NCT00612573|3178478|Superiority or Other||Mean Change from Baseline|-0.92|Standard Deviation|0.97||0.087|2-Sided|95.0|-1.5|27.3|||Cochran-Mantel-Haenszel|Stratified by Investigational Site|||
1725672|NCT00612573|3178478|Superiority or Other||Mean Change from Baseline|-0.69|Standard Deviation|0.9||0.983|2-Sided|95.0|-13.7|11.7|||Cochran-Mantel-Haenszel|Stratified by Investigational Site|||
1725673|NCT00612573|3178478|Superiority or Other||Mean Change from Baseline|-0.75|Standard Deviation|0.85||0.779|2-Sided|95.0|-14.8|10.3|||Cochran-Mantel-Haenszel|Stratified by Investigational Site|||
1725674|NCT00612534|3178483|Superiority or Other||Mean Difference (Final Values)|20.05|Standard Error of the Mean|8.3||0.018|2-Sided|95.0|3.54|36.56|||ANCOVA||||
1725675|NCT00612534|3178483|Superiority or Other||Mean Difference (Final Values)|8.67|Standard Error of the Mean|7.77||0.268|2-Sided|95.0|-6.78|24.11|||ANCOVA||||
1725676|NCT00612534|3178483|Superiority or Other||Mean Difference (Final Values)|10.26|Standard Error of the Mean|7.83||0.194||95.0|-5.32|25.83|||ANCOVA||||
1725677|NCT00612456|3178489|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.69|Standard Error of the Mean|0.594||0.249|2-Sided|95.0|-0.5|1.88|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size|
1725678|NCT00612456|3178489|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.85|Standard Error of the Mean|0.402||0.0403|2-Sided|95.0|0.04|1.65|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size|
1725679|NCT00612456|3178489|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.62|Standard Error of the Mean|0.377||0.1074|2-Sided|95.0|-0.14|1.37|||ANCOVA|||Comparison between Baseline value and Day 29 value for CNV Size|
1725680|NCT00612456|3178489|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.58|Standard Error of the Mean|0.581||0.3185|2-Sided|95.0|-0.58|1.75|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size|
1725681|NCT00612456|3178489|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|1.27|Standard Error of the Mean|0.412||0.0032|2-Sided|95.0|0.44|2.09|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size|
1725682|NCT00612456|3178489|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.46|Standard Error of the Mean|0.385||0.241|2-Sided|95.0|-0.32|1.23|||ANCOVA|||Comparison between Baseline value and Day 29 value for Total Lesion size|
1725683|NCT00612456|3178489|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.49|Standard Error of the Mean|0.566||0.3976|2-Sided|95.0|-0.7|1.68|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.|
1726253|NCT00604279|3179822|Superiority or Other||Least Square Mean Difference|0.5|Standard Error of the Mean|1.34||||95.0|-2.14|3.12|||||||
1725684|NCT00612456|3178489|Superiority or Other||Mean Difference (Final Values)|1.0|Standard Error of the Mean|0.476||0.0509|2-Sided|95.0|0.0|2.0||Statistics has been presented for least square means.|ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.|
1725685|NCT00612456|3178489|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.395||0.6018|2-Sided|95.0|-1.04|0.62|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Blood Area of measurement.|
1725686|NCT00612456|3178489|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.61||||0.3141|2-Sided|95.0|-0.6|1.83|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.|
1725687|NCT00612456|3178489|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.82|Standard Error of the Mean|0.409||0.0508|2-Sided|95.0|0.0|1.64|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.|
1725688|NCT00612456|3178489|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|0.76|Standard Error of the Mean|0.383||0.0534|2-Sided|95.0|-0.01|1.53|||ANCOVA|||Comparison between Baseline value and Day 29 value for FA Leakage Area of measurement.|
1725689|NCT00612456|3178492|Superiority or Other|Statistics has been presented for least square means based on participants with a ‘YES’ for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|0.26|Standard Error of the Mean|2.287||0.9114|2-Sided|95.0|-4.37|4.88|||ANCOVA|||Comparison between Baseline value and Day 29 value.|
1725690|NCT00612456|3178492|Superiority or Other|Statistics has been presented for least square means based on participants with a ‘YES’ for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|0.85|Standard Error of the Mean|1.419||0.5547|2-Sided|95.0|-2.02|3.71|||ANCOVA|||Comparison between Baseline value and Day 29 value.|
1725691|NCT00612456|3178492|Superiority or Other|Statistics has been presented for least square means based on participants with a ‘YES’ for eligible field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|3.53|Standard Error of the Mean|1.376||0.0142|2-Sided|95.0|0.75|6.31|||ANCOVA|||Comparison between Baseline value and Day 29 value.|
1725692|NCT00612456|3178492|Superiority or Other|Statistics has been presented for least square means based on participants with a ‘YES’ for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|-0.04|Standard Error of the Mean|1.927||0.9847|2-Sided|95.0|-3.9|3.83|||ANCOVA|||Comparison between Baseline value and Day 29 value.|
1725693|NCT00612456|3178492|Superiority or Other|Statistics has been presented for least square means based on participants with a ‘YES’ for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|1.64|Standard Error of the Mean|1.326||0.2208|2-Sided|95.0|-1.02|4.3|||ANCOVA|||Comparison between Baseline value and Day 29 value.|
1725694|NCT00612456|3178492|Superiority or Other|Statistics has been presented for least square means based on participants with a ‘YES’ for RCA NONE field from DARC FA form in study eye at screening.|Mean Difference (Final Values)|4.75||||0.0003|2-Sided|95.0|2.32|7.19|||ANCOVA|||Comparison between Baseline value and Day 29 value.|
1725695|NCT00612456|3178492|Superiority or Other|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|0.09|Standard Error of the Mean|1.988||0.9646|2-Sided|95.0|-3.89|4.07|||ANCOVA|||Comparison between Baseline value and Day 29 value.|
1725696|NCT00612456|3178492|Superiority or Other|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|0.76|Standard Error of the Mean|1.403||0.5921|2-Sided|95.0|-2.05|3.57|||ANCOVA|||Comparison between Baseline value and Day 29 value.|
1725697|NCT00612456|3178492|Superiority or Other|Statistics has been presented for least square means based on efficacy population.|Mean Difference (Final Values)|4.32|Standard Error of the Mean|1.29||0.0015|2-Sided|95.0|1.74|6.91|||ANCOVA|||Comparison between Baseline value and Day 29 value.|
1725698|NCT00612456|3178499|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|13.97|Standard Error of the Mean|20.008||0.7556|2-Sided|95.0|-26.38|54.32||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||OC Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.|
1725699|NCT00612456|3178499|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|-0.55|Standard Error of the Mean|18.3||0.488|2-Sided|95.0|-37.46|36.35||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||OC Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.|
1725700|NCT00612456|3178499|Superiority or Other|Statistics has been presented for least square means.|Mean Difference (Final Values)|19.9|Standard Error of the Mean|18.496||0.8562|2-Sided|95.0|-17.33|57.13||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||LOCF Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.|
1725701|NCT00612456|3178499|Superiority or Other|Statistics has been presented for least square means.|Median Difference (Final Values)|-0.82|Standard Error of the Mean|18.114||0.482|2-Sided|95.0|-37.28|35.64||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||LOCF Data excluding potential one outlier participant. Comparison between Baseline value and Day 29 value.|
1725725|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|2.1|Standard Error of the Mean|1.2||0.0923|2-Sided|95.0|-0.3|4.5|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL sleep domain.|
1725702|NCT00612456|3178499|Superiority or Other|Statistics has been presented for least square means using the OC dataset.|Mean Difference (Final Values)|5.2|Standard Error of the Mean|20.662||0.5987|2-Sided|95.0|-36.44|46.84||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.|
1725703|NCT00612456|3178499|Superiority or Other|Statistics has been presented for least square means using the OC dataset.|Mean Difference (Final Values)|5.76|Standard Error of the Mean|18.566||0.6212|2-Sided|95.0|-31.65|43.18||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.|
1725704|NCT00612456|3178499|Superiority or Other|Statistics has been presented for least square means using the LOCF dataset.|Mean Difference (Final Values)|11.87|Standard Error of the Mean|19.081||0.7315|2-Sided|95.0|-26.52|50.26||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.|
1725705|NCT00612456|3178499|Superiority or Other|Statistics has been presented for least square means using the LOCF dataset.|Mean Difference (Final Values)|5.83|Standard Error of the Mean|18.332||0.6241|2-Sided|95.0|-31.05|42.71||If the estimates of change from baseline in CRLT were negative, then the one-sided p-values were the two-sided t-test of each treatment arm from this analysis divided by 2. If the estimates of change from baseline in CRLT were positive, then the one|ANCOVA|||Comparison between Baseline value and Day 29 value.|
1725706|NCT00612313|3178564|Superiority or Other||Difference in percentages|9.7||||0.02|2-Sided|||||The estimated rate of time spent well was evaluated using a Poisson regression with adjustment for CDRS-R score at the end of the acute phase, age group, and gender.|Regression, Poisson||Differencein percentages represents estimated percentage for medication management + CBT Arm minus estimated percentage for medication management only Arm.||
1725707|NCT00612105|3178594|Superiority or Other||Mean Difference (Net)|-0.43||||0.2537|2-Sided|95.0|-1.171|0.312|||ANCOVA||||
1725708|NCT00611923|3178609|Superiority or Other (legacy)|paired t-test was performed comparing the Patient Globall Improvement score at treatment month 2 between placebo and flutamide groups|||||=|0|||||||t-test, 2 sided||||
1725709|NCT00611923|3178609|Superiority or Other (legacy)||||||=|0|||||||t-test, 2 sided|||paired t-test was performed comparing the Patient Global Improvement score at month 1 between placebo and flutamide groups|
1725710|NCT00611923|3178610|Superiority or Other (legacy)|paired t-test analysis comparing change from baseline CGI severity score at month 2 between flutamide and placebo groups|||||<|0.04|||||||t-test, 2 sided||||
1725711|NCT00611923|3178610|Superiority or Other (legacy)|Comparison of change from baseline score to treatment month 1 between placebo and flutamide treated subjects.|||||=|0|||||||t-test, 2 sided||||
1725712|NCT00611923|3178611|Superiority or Other (legacy)||||||=|0|||||||t-test, 2 sided|||t-test was performed comparing the Clinical Global Improvement score at month 2 between placebo and flutamide groups|
1725713|NCT00611923|3178611|Superiority or Other (legacy)||||||=|0|||||||t-test, 2 sided|||paired t-test was performed comparing the Clinical Global Improvement score at month 1 between placebo and flutamide groups|
1725714|NCT00611923|3178612|Superiority or Other (legacy)||||||=|0|||||||t-test, 2 sided||||
1725715|NCT00611923|3178612|Superiority or Other (legacy)||||||=|0|||||||t-test, 2 sided||||
1725716|NCT00611923|3178613|Superiority or Other (legacy)||||||=|0|||||||t-test, 2 sided|||paired t-test comparing change in DRSP scores from baseline to Month 2 of treatment Larger positive change score indicates a greater reduction in symptoms from baseline.|
1725717|NCT00611923|3178613|Superiority or Other (legacy)||||||=|0|||||||t-test, 2 sided|||paired t-test comparing change in DRSP scores from baseline to Month 1 of treatment Larger positive change score indicates a greater reduction in symptoms from baseline.|
1725718|NCT00611923|3178614|Superiority or Other (legacy)||||||=|0|||||||t-test, 2 sided|||paired t-test analysis comparing change from baseline PMTS score at month 2 between flutamide and placebo groups.|
1725719|NCT00611923|3178614|Superiority or Other (legacy)||||||=|0|||||||t-test, 2 sided|||paired t-test analysis comparing change from baseline PMTS score at month 1 between flutamide and placebo groups|
1725720|NCT00611455|3178807|Superiority or Other||Odds Ratio (OR)|2.86|||<|0.001|2-Sided|95.0|1.67|4.91|||Cochran-Mantel-Haenszel||||
1725721|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|2.0|Standard Error of the Mean|0.8||0.0117|2-Sided|95.0|0.4|3.5|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Fesoterodine: HRQL social interaction domain.|
1725722|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|1.2|Standard Error of the Mean|1.0||0.2208|2-Sided|95.0|-0.7|3.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL social interaction domain.|
1725723|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|3.2|Standard Error of the Mean|1.0||0.0011|2-Sided|95.0|1.3|5.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.|
1725724|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|2.4|Standard Error of the Mean|1.0||0.018|2-Sided|95.0|0.4|4.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Fesoterodine: HRQL sleep domain.|
1726497|NCT00599872|3180592|Superiority or Other||Mean Difference (Net)|-0.418|||<|0.05|2-Sided|95.0|-1.15|0.48|||ANCOVA||||
1725726|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|4.5|Standard Error of the Mean|1.2||0.0003|2-Sided|95.0|2.0|6.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.|
1725727|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|3.9|Standard Error of the Mean|1.1||0.0004|2-Sided|95.0|1.7|6.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL coping domain.|
1725728|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|3.1|Standard Error of the Mean|1.3||0.0229|2-Sided|95.0|0.4|5.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs placebo: HRQL coping domain.|
1725729|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|7.0|Standard Error of the Mean|1.4|<|0.0001|2-Sided|95.0|4.3|9.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL coping domain.|
1725730|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|4.2|Standard Error of the Mean|1.1|<|0.0001|2-Sided|95.0|2.1|6.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL concern domain.|
1725731|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|2.3|Standard Error of the Mean|1.3|<|0.0795|2-Sided|95.0|-0.3|4.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Placebo vs Tolterodine ER: HRQL concern domain.|
1725732|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|6.6|Standard Error of the Mean|1.3|<|0.0001|2-Sided|95.0|4.0|9.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo: HRQL concern domain.|
1725733|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|3.3|Standard Error of the Mean|0.9|<|0.0003|2-Sided|95.0|1.5|5.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER: HRQL scale score total.|
1725734|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|2.3|Standard Error of the Mean|1.1|<|0.0429|2-Sided|95.0|0.1|4.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Tolterodine ER vs Placebo: HRQL scale score total.|
1725735|NCT00611026|3178830|Superiority or Other||Mean Difference (Final Values)|5.6|Standard Error of the Mean|1.1|<|0.0001|2-Sided|95.0|3.4|7.9|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL scale score total.|
1725736|NCT00611026|3178831|Superiority or Other||Mean Difference (Final Values)|-4.6|Standard Error of the Mean|1.0|<|0.0001|2-Sided|95.0|-6.6|-2.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.|
1725737|NCT00611026|3178831|Superiority or Other||Mean Difference (Final Values)|-2.4|Standard Error of the Mean|1.2|<|0.0458|2-Sided|95.0|-4.8|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.|
1725738|NCT00611026|3178831|Superiority or Other||Mean Difference (Final Values)|-7.1|Standard Error of the Mean|1.2|<|0.0001|2-Sided|95.0|-9.5|-4.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.|
1725739|NCT00611026|3178832|Superiority or Other|||||||0.0016|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 12.|
1725740|NCT00611026|3178832|Superiority or Other|||||||0.006|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 12.|
1725741|NCT00611026|3178832|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 12.|
1725742|NCT00611026|3178832|Superiority or Other||||||<|0.004|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 4.|
1725743|NCT00611026|3178832|Superiority or Other||||||<|0.1485|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 4.|
1725876|NCT00610441|3178901|Superiority or Other||Odds Ratio (OR)|1.3982|||||2-Sided|95.0|0.524|3.7309|||||Proportional odds model with fixed effects for treatment and period.||
1725744|NCT00611026|3178832|Superiority or Other||||||<|0.0002|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 4.|
1725745|NCT00611026|3178832|Superiority or Other||||||<|0.3713|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs Tolterodine ER at Week 1.|
1725746|NCT00611026|3178832|Superiority or Other||||||<|0.0072|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 1.|
1725747|NCT00611026|3178832|Superiority or Other||||||<|0.0011|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 1.|
1725748|NCT00611026|3178833|Superiority or Other|||||||0.0005|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.|
1725749|NCT00611026|3178833|Superiority or Other|||||||0.0107|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 12.|
1725750|NCT00611026|3178833|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 12.|
1725751|NCT00611026|3178833|Superiority or Other||||||<|0.0177|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.|
1725752|NCT00611026|3178833|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 4.|
1725753|NCT00611026|3178833|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 4.|
1725754|NCT00611026|3178833|Superiority or Other||||||<|0.2817|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs Fesoterodine at Week 1.|
1725755|NCT00611026|3178833|Superiority or Other||||||<|0.0279|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference Tolterodine ER vs placebo at Week 1.|
1725756|NCT00611026|3178833|Superiority or Other||||||<|0.0009|||||||Cochran-Mantel-Haenszel|P-value was obtained from a Cochran-Mantel-Haenszel test (CMH) with modified ridit scoring and stratified by country.||Treatment difference fesoterodine vs placebo at Week 1.|
1725757|NCT00611026|3178834|Superiority or Other|||||||0.0169|||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 12.|
1725758|NCT00611026|3178834|Superiority or Other|||||||0.0991|||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 12.|
1725759|NCT00611026|3178834|Superiority or Other|||||||0.0003|||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 12.|
1725760|NCT00611026|3178834|Superiority or Other|||||||0.0494|||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 4.|
1725761|NCT00611026|3178834|Superiority or Other|||||||0.0063|||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 4.|
1725762|NCT00611026|3178834|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 4.|
1725763|NCT00611026|3178834|Superiority or Other||||||<|0.6514|||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs Tolterodine ER at Week 1.|
1725764|NCT00611026|3178834|Superiority or Other||||||<|0.0024|||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for Tolterodine ER vs placebo at Week 1.|
1725765|NCT00611026|3178834|Superiority or Other||||||<|0.0008|||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel test stratified by baseline UUI quartile.||Treatment difference in continent rate for fesoterodine vs placebo at Week 1.|
1725766|NCT00611026|3178835|Superiority or Other||Mean Difference (Final Values)|-2.5|Standard Error of the Mean|0.6|<|0.0001|2-Sided|95.0|-3.6|-1.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.|
1725767|NCT00611026|3178835|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.7|<|0.0859|2-Sided|95.0|-2.5|0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.|
1725768|NCT00611026|3178835|Superiority or Other||Mean Difference (Final Values)|-3.7|Standard Error of the Mean|0.7|<|0.0001|2-Sided|95.0|-5.0|-2.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.|
1726498|NCT00599755|3180593|Superiority or Other||Proportion|0.125|||||2-Sided|80.0|0.06|0.23|||||||
1725769|NCT00611026|3178835|Superiority or Other||Mean Difference (Final Values)|-1.9|Standard Error of the Mean|0.5|<|0.0006|2-Sided|95.0|-3.0|-0.8|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.|
1725770|NCT00611026|3178835|Superiority or Other||Mean Difference (Final Values)|-2.0|Standard Error of the Mean|0.7|<|0.0034|2-Sided|95.0|-3.3|-0.7|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.|
1725771|NCT00611026|3178835|Superiority or Other||Mean Difference (Final Values)|-3.9|Standard Error of the Mean|0.7|<|0.0001|2-Sided|95.0|-5.2|-2.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.|
1725772|NCT00611026|3178835|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.5|<|0.1505|2-Sided|95.0|-1.7|0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.|
1725773|NCT00611026|3178835|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.6|<|0.1918|2-Sided|95.0|-2.0|0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.|
1725774|NCT00611026|3178835|Superiority or Other||Mean Difference (Final Values)|-1.5|Standard Error of the Mean|0.6|<|0.0136|2-Sided|95.0|-2.7|-0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.|
1725775|NCT00611026|3178836|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.0||0.0004|2-Sided|95.0|-0.2|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.|
1725776|NCT00611026|3178836|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.0||0.311|2-Sided|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.|
1725777|NCT00611026|3178836|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.0|<|0.0001|2-Sided|95.0|-0.3|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.|
1725778|NCT00611026|3178836|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.0|<|0.0014|2-Sided|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.|
1725779|NCT00611026|3178836|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.0|<|0.0059|2-Sided|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.|
1725780|NCT00611026|3178836|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.0|<|0.0001|2-Sided|95.0|-0.3|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.|
1725781|NCT00611026|3178836|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.0|<|0.1702|2-Sided|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.|
1725782|NCT00611026|3178836|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.0|<|0.4823|2-Sided|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.|
1725783|NCT00611026|3178836|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.0|<|0.0701|2-Sided|95.0|-0.1|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.|
1725784|NCT00611026|3178837|Superiority or Other|||||||0.0007||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.|
1725877|NCT00610441|3178901|Superiority or Other||Odds Ratio (OR)|1.3149|||||2-Sided|95.0|0.5402|3.2008|||||Proportional odds model with fixed effects for treatment and period.||
1725878|NCT00610441|3178902|Superiority or Other||Odds Ratio (OR)|1.8548|||||2-Sided|95.0|0.6951|4.9494|||||Proportional odds model with fixed effects for treatment and period.||
1725785|NCT00611026|3178837|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.|
1725786|NCT00611026|3178837|Superiority or Other||||||<|0.0302||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.|
1725787|NCT00611026|3178837|Superiority or Other||||||<|0.0003||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.|
1725788|NCT00611026|3178837|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.|
1725789|NCT00611026|3178838|Superiority or Other|||||||0.0001|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).|
1725790|NCT00611026|3178838|Superiority or Other|||||||0.1764|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).|
1725791|NCT00611026|3178838|Superiority or Other||||||<|0.0001|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).|
1725792|NCT00611026|3178838|Superiority or Other||||||<|0.0071|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).|
1725793|NCT00611026|3178838|Superiority or Other||||||<|0.0009|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).|
1725794|NCT00611026|3178838|Superiority or Other||||||<|0.0001|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).|
1725795|NCT00611026|3178838|Superiority or Other||||||<|0.3555|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference fesoterodine vs Tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).|
1725796|NCT00611026|3178838|Superiority or Other||||||<|0.223|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||Treatment difference Tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).|
1725797|NCT00611026|3178838|Superiority or Other||||||<|0.0576|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of severe urgency episodes.||"Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95 percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations > 5%) a non-parametric analysis was to be conducted using Van Elteren’s test stratified by baseline quartile of the diary variable analyzed."|
1725798|NCT00611026|3178839|Superiority or Other|||||||0.0008||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.|
1725799|NCT00611026|3178839|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.|
1725879|NCT00610441|3178902|Superiority or Other||Odds Ratio (OR)|1.2074|||||2-Sided|95.0|0.5654|2.5785|||||Proportional odds model with fixed effects for treatment and period.||
1726499|NCT00599755|3180597|Superiority or Other||Concordance correlation coefficient|0.88|||||2-Sided|80.0|0.85|0.92|||||||
1725800|NCT00611026|3178839|Superiority or Other||||||<|0.0022||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.|
1725801|NCT00611026|3178839|Superiority or Other||||||<|0.0008||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.|
1725802|NCT00611026|3178839|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.|
1725803|NCT00611026|3178839|Superiority or Other||||||<|0.0828||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.|
1725804|NCT00611026|3178840|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|-1.1|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 12.|
1725805|NCT00611026|3178840|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.2|<|0.1467|2-Sided|95.0|-0.7|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 12.|
1725806|NCT00611026|3178840|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|-1.5|-0.6|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 12.|
1725807|NCT00611026|3178840|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.2|<|0.0005|2-Sided|95.0|-0.9|-0.3|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 4.|
1725808|NCT00611026|3178840|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.2|<|0.0054|2-Sided|95.0|-1.0|-0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 4.|
1725809|NCT00611026|3178840|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|-1.6|-0.8|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 4.|
1725810|NCT00611026|3178840|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1|<|0.1817|2-Sided|95.0|-0.5|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs Fesoterodine at Week 1.|
1725811|NCT00611026|3178840|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.2|<|0.3161|2-Sided|95.0|-0.5|0.2|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference Tolterodine ER vs placebo at Week 1.|
1725812|NCT00611026|3178840|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.2|<|0.0374|2-Sided|95.0|-0.7|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type: standard error of the mean.|Treatment difference fesoterodine vs placebo at Week 1.|
1725813|NCT00611026|3178841|Superiority or Other|||||||0.0093||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 12.|
1725814|NCT00611026|3178841|Superiority or Other|||||||0.0805||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 12.|
1725815|NCT00611026|3178841|Superiority or Other|||||||0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.|
1725816|NCT00611026|3178841|Superiority or Other|||||||0.0219||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs Fesoterodine at Week 4.|
1725817|NCT00611026|3178841|Superiority or Other|||||||0.0038||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.|
1725818|NCT00611026|3178841|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.|
1725819|NCT00611026|3178841|Superiority or Other||||||<|0.0205||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 1.|
1725820|NCT00611026|3178841|Superiority or Other||||||<|0.0012||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.|
1725821|NCT00611026|3178842|Superiority or Other|||||||0.0148|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725822|NCT00611026|3178842|Superiority or Other|||||||0.0019|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725823|NCT00611026|3178842|Superiority or Other||||||<|0.0001|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725824|NCT00611026|3178842|Superiority or Other||||||<|0.2126|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725825|NCT00611026|3178842|Superiority or Other||||||<|0.0202|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725826|NCT00611026|3178842|Superiority or Other||||||<|0.0006|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||"Treatment difference fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations > 5%) a non-parametric analysis was to be conducted using Van Elteren’s test stratified by baseline quartile of the diary variable analyzed."|
1725827|NCT00611026|3178843|Superiority or Other|||||||0.02||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.|
1725828|NCT00611026|3178843|Superiority or Other|||||||0.0021||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with terms for country and treatment and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.|
1725829|NCT00611026|3178844|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.0||0.1661|2-Sided|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 12.|
1725830|NCT00611026|3178844|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.1||0.1759|2-Sided|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 12.|
1725831|NCT00611026|3178844|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.1||0.0134|2-Sided|95.0|-0.3|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 12.|
1726500|NCT00599755|3180598|Superiority or Other||Proportion|0.4|||||2-Sided|80.0|0.27|0.55|||||||
1725832|NCT00611026|3178844|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.0||0.5906|2-Sided|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 4.|
1725833|NCT00611026|3178844|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.0794|2-Sided|95.0|-0.2|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 4.|
1725834|NCT00611026|3178844|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.1||0.0286|2-Sided|95.0|-0.12|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 4.|
1725835|NCT00611026|3178844|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.0||0.8355|2-Sided|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 1.|
1725836|NCT00611026|3178844|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.1||0.4802|2-Sided|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 1.|
1725837|NCT00611026|3178844|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.1||0.3823|2-Sided|95.0|-0.1|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 1.|
1725838|NCT00611026|3178845|Superiority or Other|||||||0.0023||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs Tolterodine ER at Week 12.|
1725839|NCT00611026|3178845|Superiority or Other|||||||0.0421||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 12.|
1725840|NCT00611026|3178845|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 12.|
1725841|NCT00611026|3178845|Superiority or Other||||||<|0.0217||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs Tolterodine ER at Week 4.|
1725842|NCT00611026|3178845|Superiority or Other||||||<|0.002||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference Tolterodine ER vs placebo at Week 4.|
1725843|NCT00611026|3178845|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 4.|
1725844|NCT00611026|3178845|Superiority or Other||||||<|0.0217||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment difference fesoterodine vs placebo at Week 1.|
1725845|NCT00611026|3178846|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.1||0.0016|2-Sided|95.0|-0.6|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 12.|
1725846|NCT00611026|3178846|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0407|2-Sided|95.0|-0.6|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 12.|
1725880|NCT00610441|3178905|Superiority or Other||Odds Ratio (OR)|0.1453|||||2-Sided|95.0|0.0152|1.388|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.||
1726542|NCT00596934|3180803|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1725847|NCT00611026|3178846|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.9|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 12.|
1725848|NCT00611026|3178846|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1|<|0.0186|2-Sided|95.0|-0.5|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 4.|
1725849|NCT00611026|3178846|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.1|<|0.0043|2-Sided|95.0|-0.6|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 4.|
1725850|NCT00611026|3178846|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.9|-0.4|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 4.|
1725851|NCT00611026|3178846|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1|<|0.3613|2-Sided|95.0|-0.3|0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs Tolterodine ER at Week 1.|
1725852|NCT00611026|3178846|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1|<|0.0944|2-Sided|95.0|-0.4|0.0|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference Tolterodine ER vs placebo at Week 1.|
1725853|NCT00611026|3178846|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1|<|0.0161|2-Sided|95.0|-0.5|-0.1|||ANCOVA|Based on an analysis of covariance model with terms for country and treatment and with baseline value as a covariate.|"Treatment difference LSMean difference (SE), SE is recorded as parameter dispersion type:~standard error of the mean."|Treatment difference fesoterodine vs placebo at Week 1.|
1725854|NCT00611026|3178847|Superiority or Other|||||||0.0525|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725855|NCT00611026|3178847|Superiority or Other|||||||0.0021|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725856|NCT00611026|3178847|Superiority or Other||||||<|0.0001|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725857|NCT00611026|3178847|Superiority or Other||||||<|0.013|||||||Van Elteren's|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725858|NCT00611026|3178847|Superiority or Other||||||<|0.0002|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725859|NCT00611026|3178847|Superiority or Other||||||<|0.0001|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs placebo at Week 4. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725860|NCT00611026|3178847|Superiority or Other||||||<|0.1503|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference fesoterodine vs tolterodine ER at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725861|NCT00611026|3178847|Superiority or Other||||||<|0.0519|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||Treatment difference tolterodine ER vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725862|NCT00611026|3178847|Superiority or Other||||||<|0.002|||||||Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline quartile of voided volume.||"Treatment difference fesoterodine vs placebo at Week 1. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations > 5%) a non-parametric analysis was to be conducted using Van Elteren’s test stratified by baseline quartile of the diary variable analyzed."|
1725881|NCT00610441|3178905|Superiority or Other||Odds Ratio (OR)|6.2468|||||2-Sided|95.0|0.6712|58.1395|||||Since no participants in the Placebo group achieved a 50% reduction, the comparison was done using a Cochran-Mantel-Haenszel method and 0.5 was added to both groups.||
1725863|NCT00611026|3178848|Superiority or Other|||||||0.0072||||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference fesoterodine vs tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725864|NCT00611026|3178848|Superiority or Other|||||||0.0228||||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment difference tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1725865|NCT00611026|3178848|Superiority or Other||||||<|0.0001||||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||"Treatment difference fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively).~If normality assumptions were severely violated (proportion of non normal observations > 5%) a non-parametric analysis was to be conducted using Van Elteren’s test stratified by baseline quartile of the diary variable analyzed."|
1725866|NCT00610987|3178849|Superiority or Other||||||=|0|||||||t-test, 1 sided||||
1725867|NCT00610701|3178864|Superiority or Other||||||>|0.05|||||||t-test, 1 sided||||
1725868|NCT00610441|3178897|Superiority or Other||Mean Difference (Net)|1.1022||||0.5247|2-Sided|97.5|-2.8951|5.0996||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline TASS score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).|
1725869|NCT00610441|3178897|Superiority or Other||Mean Difference (Net)|-0.9685||||0.6532|2-Sided|97.5|-5.9599|4.0229|||MMRM|To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline TASS score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).|
1725870|NCT00610441|3178898|Superiority or Other||Mean Difference (Net)|0.4222||||0.2883|2-Sided|97.5|-0.5187|1.363||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline QIDS-C score as covariate. Scores from Days 14 and 21 were averaged for statistical analyses.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).|
1725871|NCT00610441|3178898|Superiority or Other||Mean Difference (Net)|-0.1543||||0.7828|2-Sided|97.5|-1.4898|1.1811||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline QIDS-C score as covariate. Scores from Days 14 and 21 were averaged for statistical analyses.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).|
1725872|NCT00610441|3178899|Superiority or Other||Mean Difference (Net)|-0.0065||||0.9872|2-Sided|97.5|-0.9486|0.9357||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline PSQI score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).|
1725873|NCT00610441|3178899|Superiority or Other||Mean Difference (Net)|0.5501||||0.3907|2-Sided|97.5|-0.9427|2.0429||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline PSQI score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).|
1725874|NCT00610441|3178900|Superiority or Other||Mean Difference (Net)|1.2934||||0.133|2-Sided|97.5|-0.7449|3.3317||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline ESS score as covariate. For statistical analyses, the average score from Days 14 and 21 was used.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).|
1725875|NCT00610441|3178900|Superiority or Other||Mean Difference (Net)|-0.3163||||0.6155|2-Sided|97.5|-1.8138|1.1812||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline ESS score as covariate. For statistical analyses, the average score from Days 14 and 21 was used.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).|
1726131|NCT00606905|3179480|Superiority or Other||Odds Ratio (OR)|1.37|||<|0.05|2-Sided|95.0|0.41|4.61|||Chi-squared||||
1725882|NCT00610441|3178906|Superiority or Other||Odds Ratio (OR)|0.9461|||||2-Sided|95.0|0.3119|2.8701|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.||
1725883|NCT00610441|3178906|Superiority or Other||Odds Ratio (OR)|6.8506|||||2-Sided|95.0|1.799|26.0878|||||Logistic regression with fixed effects for treatment and period, and baseline AISRS score as covariate.||
1725884|NCT00610441|3178907|Superiority or Other||Mean Difference (Net)|0.9926||||0.591|2-Sided|97.5|-3.2961|5.2814||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|MMRM||MMRM with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline AISRS score as covariate.|The treatment difference between 100-300 mg MK-8777 rising dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).|
1725885|NCT00610441|3178907|Superiority or Other||Mean Difference (Net)|-5.6996||||0.0147|2-Sided|97.5|-10.911|-0.4881||To correct for multiplicity, p-values (2-sided) should be compared with the 2.5% level of significance.|Mixed Model for Repeated Measurements||Mixed Model for Repeated Measurements (MMRM) with fixed effects for treatment, period, visit, center and treatment by visit interaction, and random effect for participant, and baseline AISRS score as covariate.|The treatment difference between 100 mg MK-8777 fixed dose and Placebo was estimated for the average effect (average change from baseline) of the 2nd and 3rd week of each period (Day 14 and Day 21).|
1725886|NCT00610428|3178908|Superiority|Survival time is defined as time to the first successful headache relief.||||||0.0383||||||p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)|Survival||||
1725887|NCT00610428|3178908|Superiority|||||||0.084||||||p-values calculated by Log-rank Test in step-down sequence (10 mg to 5 mg)|Survival|||Survival time is defined as time to the first successful headache relief.|
1725888|NCT00609947|3178954|Superiority or Other||Cox Proportional Hazard|13.5|Standard Error of the Mean|6.5||0.0041|1-Sided|95.0||20.0|||t-test, 1 sided|||"The null and alternative hypotheses of interest are:~H0: xSVS >= 20% vs. H1: xSVS < 20%, where x is the true SVS 12-month MACE rate.~The assessment of the null hypothesis will be carried out at the one-sided 0.05 level of significance. Rejection of the null hypothesis indicates the SVS 12-month MACE rate is significantly below 20%."|
1725889|NCT00609947|3178955|Superiority or Other||Mean Difference (Final Values)|49.2|Standard Deviation|21.8|<|0.001|1-Sided|95.0||||"The null and alternative hypotheses were:~H0: µSVS ≥µM H1: µSVS < µM where µSVS was the mean in-segment 8-month percent diameter stenosis for the SVS study and µM was the mean in-segment 6-month percent diameter stenosis for Micro-Driver."|t-test, 2 sided|The sample size was not reduced below 158 evaluable subjects in order to support the analysis of the primary safety endpoint.||The 8-month in-segment percent diameter stenosis from Endeavor SVS subjects was compared to the 6-month in-segment percent diameter stenosis from Micro Driver subjects. This study assessed the superiority of SVS against the Micro-Driver regarding in-segment percent diameter stenosis at 8 months post procedure.|
1725890|NCT00609674|3178980|Superiority or Other|||||||0.004|||||||ANCOVA||||
1725891|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|-0.06||||0.7108|2-Sided|95.0|-0.39|0.27|||t-test, 2 sided|||Differences in item 13 between treatment arms (EOT) was analyzed from a two-sample t-test.|
1725892|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|0.0|||<|0.0001|2-Sided|95.0|0.0|0.0|||t-test, 2 sided|||Differences in item 13 between treatment arms (C34 of D1) was analyzed from a two-sample t-test.|
1725893|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|1.25|||<|0.3273|2-Sided|95.0|-2.16|4.66|||t-test, 2 sided|||Differences in item 13 between treatment arms (C31 of D1) was analyzed from a two-sample t-test.|
1725894|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|-0.4|||<|0.7309|2-Sided|95.0|-2.95|2.15|||t-test, 2 sided|||Differences in item 13 between treatment arms (C28 of D1) was analyzed from a two-sample t-test.|
1725895|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|0.57|||<|0.5661|2-Sided|95.0|-1.53|2.67|||t-test, 2 sided|||Differences in item 13 between treatment arms (C25 of D1) was analyzed from a two-sample t-test.|
1725896|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|0.0|||<|1|2-Sided|95.0|-0.86|0.86|||t-test, 2 sided|||Differences in item 13 between treatment arms (C22 of D1) was analyzed from a two-sample t-test.|
1725897|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|0.34|||<|0.3277|2-Sided|95.0|-0.36|1.05|||t-test, 2 sided|||Differences in item 13 between treatment arms (C19 of D1) was analyzed from a two-sample t-test.|
1725898|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|-0.03|||<|0.9151|2-Sided|95.0|-0.55|0.5|||t-test, 2 sided|||Differences in item 13 between treatment arms (C16 of D1) was analyzed from a two-sample t-test.|
1725899|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|-0.27|||<|0.1403|2-Sided|95.0|-0.62|0.09|||t-test, 2 sided|||Differences in item 13 between treatment arms (C13 of D1) was analyzed from a two-sample t-test.|
1725900|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|-0.18|||<|0.2776|2-Sided|95.0|-0.5|0.14|||t-test, 2 sided|||Differences in item 13 between treatment arms (C10 of D1) was analyzed from a two-sample t-test.|
1725901|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|-0.12|||<|0.2747|2-Sided|95.0|-0.33|0.09|||t-test, 2 sided|||Differences in item 13 between treatment arms (C7 of D1) was analyzed from a two-sample t-test.|
1725902|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|0.0|||<|0.9788|2-Sided|95.0|-0.19|0.19|||t-test, 2 sided|||Differences in item 13 between treatment arms (C4 of D1) was analyzed from a two-sample t-test.|
1725903|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|-0.74|||<|0.6921|2-Sided|95.0|-4.43|2.95|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (EOT) was analyzed from a two-sample t-test.|
1725904|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|0.0|||<|0.0001|2-Sided|95.0|0.0|0.0|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C34 of D1) was analyzed from a two-sample t-test.|
1725905|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|1.75|||<|0.7289|2-Sided|95.0|-12.88|16.38|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C31 of D1) was analyzed from a two-sample t-test.|
1725906|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|1.0|||<|0.9081|2-Sided|95.0|-18.05|20.05|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C28 of D1) was analyzed from a two-sample t-test.|
1725907|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|3.93|||<|0.6832|2-Sided|95.0|-16.41|24.26|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C25 of D1) was analyzed from a two-sample t-test.|
1725908|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|8.27|||<|0.0483|2-Sided|95.0|0.07|16.46|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C22 of D1) was analyzed from a two-sample t-test.|
1725909|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|4.18|||<|0.2052|2-Sided|95.0|-2.4|10.76|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C19 of D1) was analyzed from a two-sample t-test.|
1725910|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|-1.03|||<|0.7046|2-Sided|95.0|-6.44|4.38|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C16 of D1) was analyzed from a two-sample t-test.|
1725911|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|-1.22|||<|0.5808|2-Sided|95.0|-5.62|3.17|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C13 of D1) was analyzed from a two-sample t-test.|
1725912|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|-2.76|||<|0.0797|2-Sided|95.0|-5.85|0.33|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C10 of D1) was analyzed from a two-sample t-test.|
1725913|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|-0.44|||<|0.6977|2-Sided|95.0|-2.67|1.79|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C7 of D1) was analyzed from a two-sample t-test.|
1725914|NCT00609622|3178983|Superiority or Other||Mean Difference (Net)|-0.63|||<|0.5081|2-Sided|95.0|-2.5|1.24|||t-test, 2 sided|||Differences in neurotoxicity between treatment arms (C4 of D1) was analyzed from a two-sample t-test.|
1725915|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.58||||0.5891|2-Sided|95.0|-2.71|1.55|||t-test, 2 sided|||Differences in CCS between treatment arms (EOT) was analyzed from a two-sample t-test.|
1725916|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|0.0|||<|0.0001|2-Sided|95.0|0.0|0.0|||t-test, 2 sided|||Differences in CCS between treatment arms (C34 of D1) was analyzed from a two-sample t-test.|
1725917|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-3.75|||<|0.4968|2-Sided|95.0|-19.23|11.73|||t-test, 2 sided|||Differences in CCS between treatment arms (C31 of D1) was analyzed from a two-sample t-test.|
1725918|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-2.4|||<|0.685|2-Sided|95.0|-15.36|10.56|||t-test, 2 sided|||Differences in CCS between treatment arms (C28 of D1) was analyzed from a two-sample t-test.|
1725919|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.27|||<|0.9635|2-Sided|95.0|-12.56|12.02|||t-test, 2 sided|||Differences in CCS between treatment arms (C25 of D1) was analyzed from a two-sample t-test.|
1725920|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.07|||<|0.5857|2-Sided|95.0|-5.05|2.92|||t-test, 2 sided|||Differences in CCS between treatment arms (C22 of D1) was analyzed from a two-sample t-test.|
1725921|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.77|||<|0.2901|2-Sided|95.0|-5.12|1.58|||t-test, 2 sided|||Differences in CCS between treatment arms (C19 of D1) was analyzed from a two-sample t-test.|
1725922|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.07|||<|0.9567|2-Sided|95.0|-2.64|2.5|||t-test, 2 sided|||Differences in CCS between treatment arms (C16 of D1) was analyzed from a two-sample t-test.|
1725923|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.13|||<|0.3499|2-Sided|95.0|-3.53|1.27|||t-test, 2 sided|||Differences in CCS between treatment arms (C13 of D1) was analyzed from a two-sample t-test.|
1725924|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.88|||<|0.3943|2-Sided|95.0|-2.9|1.15|||t-test, 2 sided|||Differences in CCS between treatment arms (C10 of D1) was analyzed from a two-sample t-test.|
1725925|NCT00609622|3178984|Superiority or Other||Mean Difference (Final Values)|-0.74|||<|0.3858|2-Sided|95.0|-2.44|0.95|||t-test, 2 sided|||Differences in CCS between treatment arms (C7 of D1) was analyzed from a two-sample t-test.|
1725926|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.36|||<|0.051|2-Sided|95.0|-2.72|0.01|||t-test, 2 sided|||Differences in CCS between treatment arms (C4 of D1) was analyzed from a two-sample t-test.|
1725927|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.76|||<|0.1309|2-Sided|95.0|-4.05|0.53|||t-test, 2 sided|||Differences in FWB between treatment arms (EOT) was analyzed from a two-sample t-test.|
1725928|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|0.0|||<|0.0001|2-Sided|95.0|0.0|0.0|||t-test, 2 sided|||Differences in FWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.|
1725929|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|5.0|||<|0.3527|2-Sided|95.0|-12.91|22.91|||t-test, 2 sided|||Differences in FWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.|
1725930|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|13.78|||<|0.0247|2-Sided|95.0|2.26|25.29|||t-test, 2 sided|||Differences in FWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.|
1725931|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|13.0|||<|0.0136|2-Sided|95.0|3.15|22.85|||t-test, 2 sided|||Differences in FWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.|
1725932|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|1.46|||<|0.5494|2-Sided|95.0|-3.5|6.41|||t-test, 2 sided|||Differences in FWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.|
1725933|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.4|||<|0.8344|2-Sided|95.0|-4.25|3.45|||t-test, 2 sided|||Differences in FWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.|
1725934|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|0.03|||<|0.9779|2-Sided|95.0|-2.39|2.45|||t-test, 2 sided|||Differences in FWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.|
1725935|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.27|||<|0.327|2-Sided|95.0|-3.82|1.29|||t-test, 2 sided|||Differences in FWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.|
1725936|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.09|||<|0.2999|2-Sided|95.0|-3.17|0.99|||t-test, 2 sided|||Differences in FWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.|
1726164|NCT00606580|3179502|Superiority or Other|||||||0.005|||||||Chi-squared||||
1725937|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.04|||<|0.2793|2-Sided|95.0|-2.92|0.85|||t-test, 2 sided|||Differences in FWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.|
1725938|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-2.34|||<|0.0055|2-Sided|95.0|-3.98|-0.7|||t-test, 2 sided|||Differences in FWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.|
1725939|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.42|||<|0.6699|2-Sided|95.0|-2.37|1.53|||t-test, 2 sided|||Differences in EWB between treatment arms (EOT) was analyzed from a two-sample t-test.|
1725940|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|0.0|||<|0.0001|2-Sided|95.0|0.0|0.0|||t-test, 2 sided|||Differences in EWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.|
1725941|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.25|||<|0.9635|2-Sided|95.0|-16.26|15.76|||t-test, 2 sided|||Differences in EWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.|
1725942|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|3.9|||<|0.3087|2-Sided|95.0|-4.28|12.08|||t-test, 2 sided|||Differences in EWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.|
1725943|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|4.27|||<|0.4507|2-Sided|95.0|-7.53|16.06|||t-test, 2 sided|||Differences in EWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.|
1725944|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.88|||<|0.5874|2-Sided|95.0|-4.2|2.43|||t-test, 2 sided|||Differences in EWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.|
1725945|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.6|||<|0.675|2-Sided|95.0|-3.46|2.27|||t-test, 2 sided|||Differences in EWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.|
1725946|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.12|||<|0.9191|2-Sided|95.0|-2.4|2.17|||t-test, 2 sided|||Differences in EWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.|
1725947|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.09|||<|0.9335|2-Sided|95.0|-2.12|1.95|||t-test, 2 sided|||Differences in EWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.|
1725948|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.25|||<|0.7502|2-Sided|95.0|-1.84|1.33|||t-test, 2 sided|||Differences in EWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.|
1725949|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.06|||<|0.9302|2-Sided|95.0|-1.31|1.2|||t-test, 2 sided|||Differences in EWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.|
1725950|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.44|||<|0.4623|2-Sided|95.0|-1.63|0.74|||t-test, 2 sided|||Differences in EWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.|
1725951|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|0.27|||<|0.6785|2-Sided|95.0|-1.03|1.58|||t-test, 2 sided|||Differences in SWB between treatment arms (EOT) was analyzed from a two-sample t-test.|
1725952|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|0.0|||<|0.0001|2-Sided|95.0|0.0|0.0|||t-test, 2 sided|||Differences in SWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.|
1725953|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-7.58|||<|0.1271|2-Sided|95.0|-19.08|3.93|||t-test, 2 sided|||Differences in SWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.|
1725954|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-2.85|||<|0.5715|2-Sided|95.0|-13.83|8.13|||t-test, 2 sided|||Differences in SWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.|
1725955|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-3.94|||<|0.3781|2-Sided|95.0|-13.22|5.34|||t-test, 2 sided|||Differences in SWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.|
1725956|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|0.51|||<|0.7554|2-Sided|95.0|-2.85|3.87|||t-test, 2 sided|||Differences in SWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.|
1725957|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|0.67|||<|0.6314|2-Sided|95.0|-2.15|3.5|||t-test, 2 sided|||Differences in SWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.|
1725958|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|0.6|||<|0.5779|2-Sided|95.0|-1.55|2.75|||t-test, 2 sided|||Differences in SWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.|
1725959|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|1.09|||<|0.195|2-Sided|95.0|-0.57|2.76|||t-test, 2 sided|||Differences in SWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.|
1725960|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.94|||<|0.2105|2-Sided|95.0|-2.41|0.54|||t-test, 2 sided|||Differences in SWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.|
1725961|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.51|||<|0.4642|2-Sided|95.0|-1.87|0.86|||t-test, 2 sided|||Differences in SWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.|
1725962|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.28|||<|0.6122|2-Sided|95.0|-1.37|0.81|||t-test, 2 sided|||Differences in SWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.|
1725963|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-0.64|||<|0.5587|2-Sided|95.0|-2.8|1.52|||t-test, 2 sided|||Differences in PWB between treatment arms (EOT) was analyzed from a two-sample t-test.|
1725964|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|0.0|||<|0.0001|2-Sided|95.0|0.0|0.0|||t-test, 2 sided|||Differences in PWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.|
1725965|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|5.75|||<|0.4667|2-Sided|95.0|-16.26|27.76|||t-test, 2 sided|||Differences in PWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.|
1725966|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|5.6|||<|0.3266|2-Sided|95.0|-6.61|17.81|||t-test, 2 sided|||Differences in PWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.|
1725967|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|8.9|||<|0.038|2-Sided|95.0|0.57|17.23|||t-test, 2 sided|||Differences in PWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.|
1725968|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|0.41|||<|0.8184|2-Sided|95.0|-3.22|4.04|||t-test, 2 sided|||Differences in PWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.|
1725969|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.97|||<|0.2211|2-Sided|95.0|-5.18|1.24|||t-test, 2 sided|||Differences in PWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.|
1725970|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.05|||<|0.4233|2-Sided|95.0|-3.68|1.57|||t-test, 2 sided|||Differences in PWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.|
1725971|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.64|||<|0.1339|2-Sided|95.0|-3.81|0.52|||t-test, 2 sided|||Differences in PWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.|
1725972|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.81|||<|0.0522|2-Sided|95.0|-3.64|0.02|||t-test, 2 sided|||Differences in PWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.|
1725973|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.45|||<|0.0876|2-Sided|95.0|-3.11|0.22|||t-test, 2 sided|||Differences in PWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.|
1725974|NCT00609622|3178984|Superiority or Other||Mean Difference (Net)|-1.4|||<|0.0515|2-Sided|95.0|-2.82|0.01|||t-test, 2 sided|||Differences in PWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.|
1725975|NCT00609622|3178986|Superiority or Other||F-Distribution|3.956||||0.5898|2-Sided|95.0|-10.412|18.324|||Chi-squared||||
1725976|NCT00609622|3178989|Superiority or Other||Hazard Ratio (HR)|1.618||||0.9289|2-Sided|95.0|0.845|3.096|||Log Rank|||P-value was calculated from a 1-sided, log-rank test stratified for ECOG Performance Status (0 vs. 1), Baseline LDH: >1.5 vs. <=1.5 * ULN, and Prior Adjuvant Treatment (yes vs. no).|
1725977|NCT00609622|3178990|Superiority or Other||Hazard Ratio (HR)|2.705||||0.9963|2-Sided|95.0|1.272|5.751|||Log Rank|||P-value was calculated from a 1-sided, log-rank test stratified for Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), Baseline Lactate Dehydrogenase (LDH): greater than (>) 1.5 vs. less than or equal to (<=) 1.5 * upper limit of normal range (ULN), and Prior Adjuvant Treatment (yes vs. no).|
1725978|NCT00609518|3178994|Superiority or Other||Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.57|1.38|||||||
1725979|NCT00609518|3178994|Superiority or Other|||||||0.587|||||||Log Rank||||
1725980|NCT00609518|3178995|Superiority or Other||Hazard Ratio (HR)|0.9|||||2-Sided|95.0|0.54|1.49|||||||
1725981|NCT00609518|3178995|Superiority or Other|||||||0.6791|||||||Log Rank||||
1725982|NCT00609518|3178996|Superiority or Other|||||||0.4902|||||||Fisher Exact||||
1725983|NCT00609518|3178997|Superiority or Other||Risk Difference (RD)|0.09|||||2-Sided|95.0|-0.1|0.28|||||||
1725984|NCT00609466|3179026|Superiority or Other||Least square means|108.2||||0.0002||95.0|51.9|164.5||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.|
1725985|NCT00609466|3179027|Superiority or Other||Least square mean|36.4|||<|0.0001||95.0|20.7|52.0||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.|
1725986|NCT00609466|3179028|Superiority or Other||Least square mean|20.6|||<|0.0001||95.0|13.2|28.0||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.|
1725987|NCT00609466|3179029|Superiority or Other||Least square means|9.9|||<|0.0001||95.0|6.2|13.6||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.|
1725988|NCT00609466|3179030|Superiority or Other||Least square mean|37.5|||<|0.0001||95.0|22.7|52.2||No multiplicity adjustment used|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.|
1725989|NCT00609466|3179031|Superiority or Other||||||<|0.0001||||||Test for time (in hours) to first rescue medication use. No multiplicity adjustment.|Log Rank|Adjusted for site|||
1725990|NCT00609466|3179032|Superiority or Other||Least square mean|70.8|||<|0.0001||95.0|35.9|105.6||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.||Null hypothesis of no treatment difference.|
1725991|NCT00609362|3179034|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1725992|NCT00609362|3179035|Superiority or Other|||||||0.056|||||||t-test, 2 sided||||
1725993|NCT00609362|3179036|Superiority or Other|||||||0.055||||||P-value is un-adjusted. A priori threshold for significance: 0.05|t-test, 2 sided|||The minimum number of participants was determined by power calculations to be 44 (22 in each group), assuming a difference in change in BMD of 1.7%, a standard deviation of 2%, a power of 80%, and a level of significance of 5%.|
1725994|NCT00609245|3179062|Superiority or Other|||||||0.016|||||||ANOVA||||
1725995|NCT00609128|3179072|Superiority or Other||||||<|0.05|||||||ANOVA|ANOVA with preplanned comparisons was used to generate two tailed P values. Paired t tests were used to make appropriate post-ANOVA comparisons.||"tears were collected in season from eyes of allergic patients with or without olopatadine treatment, that is one eye was treated and the patients other eye was not.~Tears from each patient's eyes were pooled to provide enough volume."|
1725996|NCT00608985|3179073|Superiority or Other||Median Difference (Net)|-6.1||||0.0121|2-Sided|95.0|-10.8|-1.4|||Wilcoxon rank-sum|||Change from baseline to week 1&2 compared with placebo|
1725997|NCT00608985|3179073|Superiority or Other||Median Difference (Net)|-7.1||||0.0017|2-Sided|95.0|-11.5|-2.7|||Wilcoxon rank-sum|||Change from baseline to week 1&2 compared with placebo|
1725998|NCT00608985|3179073|Superiority or Other||Median Difference (Net)|-4.1||||0.1187|2-Sided|95.0|-9.1|0.9|||Wilcoxon rank-sum|||Change from baseline to week 1&2 compared with placebo|
1725999|NCT00608985|3179074|Superiority or Other||Median Difference (Net)|-10.5||||0.0017|2-Sided|95.0|-17.3|-4.0|||Wilcoxon rank-sum|||Change from baseline to day 15&16 compared with placebo|
1726000|NCT00608985|3179074|Superiority or Other||Median Difference (Net)|-6.0||||0.0607|2-Sided|95.0|-12.3|0.3|||Wilcoxon rank-sum|||Change from baseline to day 15&16 compared with placebo|
1726001|NCT00608985|3179074|Superiority or Other||Median Difference (Net)|-4.0||||0.2237|2-Sided|95.0|-11.0|2.5|||Wilcoxon rank-sum|||Change from baseline to day 15&16 compared with placebo|
1726002|NCT00608985|3179075|Superiority or Other||Median Difference (Net)|-16.0|||<|0.0001|2-Sided|95.0|-22.0|-9.8|||Wilcoxon rank-sum|||Change from baseline to day 1&2 compared with placebo|
1726003|NCT00608985|3179075|Superiority or Other||Median Difference (Net)|-9.5|||<|0.0006|2-Sided|95.0|-15.0|-4.3|||Wilcoxon rank-sum|||Change from baseline to day 1&2 compared with placebo|
1726004|NCT00608985|3179075|Superiority or Other||Median Difference (Net)|-9.3|||<|0.0035|2-Sided|95.0|-15.3|-3.0|||Wilcoxon rank-sum|||Change from baseline to day 1&2 compared with placebo|
1726005|NCT00608985|3179076|Superiority or Other||Median Difference (Net)|-12.7|||<|0.0001|2-Sided|95.0|-18.8|-6.6|||Wilcoxon rank-sum|||Change from baseline to week 1&2 compared with placebo|
1726006|NCT00608985|3179076|Superiority or Other||Median Difference (Net)|-10.4|||<|0.0006|2-Sided|95.0|-16.4|-4.6|||Wilcoxon rank-sum|||Change from baseline to week 1&2 compared with placebo|
1726007|NCT00608985|3179076|Superiority or Other||Median Difference (Net)|-7.3|||<|0.0186|2-Sided|95.0|-13.3|-1.3|||Wilcoxon rank-sum|||Change from baseline to week 1&2 compared with placebo|
1726008|NCT00608985|3179077|Superiority or Other||Median Difference (Net)|3.5||||0.3358|2-Sided|95.0|-3.8|11.0|||Wilcoxon rank-sum|||Change from baseline to day 15&16 compared with placebo|
1726009|NCT00608985|3179077|Superiority or Other||Median Difference (Net)|-19.5|||<|0.0001|2-Sided|95.0|-27.3|-12.3|||Wilcoxon rank-sum|||Change from baseline to day 15&16 compared with placebo|
1726010|NCT00608985|3179077|Superiority or Other||Median Difference (Net)|-13.5|||<|0.0001|2-Sided|95.0|-20.3|-6.5|||Wilcoxon rank-sum|||Change from baseline to day 15&16 compared with placebo|
1726011|NCT00608985|3179078|Superiority or Other||Median Difference (Net)|-6.8||||0.0376|2-Sided|95.0|-13.5|-0.3|||Wilcoxon rank-sum|||Change from baseline to day 1&2 compared with placebo|
1726012|NCT00608985|3179078|Superiority or Other||Median Difference (Net)|-26.8|||<|0.0001|2-Sided|95.0|-34.3|-19.5|||Wilcoxon rank-sum|||Change from baseline to day 1&2 compared with placebo|
1726013|NCT00608985|3179078|Superiority or Other||Median Difference (Net)|-15.0|||<|0.0001|2-Sided|95.0|-21.8|-8.8|||Wilcoxon rank-sum|||Change from baseline to day 1&2 compared with placebo|
1726014|NCT00608959|3179081|Superiority or Other||Median Difference (Final Values)|-1.87|Standard Deviation|1.656|<|0.001||95.0|-2.57|-1.17|||t-test, 2 sided|||Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.|
1726015|NCT00608959|3179081|Superiority or Other||Mean Difference (Final Values)|-1.91|Standard Deviation|1.563|<|0.001||95.0|-2.55|-1.26|||t-test, 2 sided|||Based on a two-sided test at the 5% level of significance, and assuming a SD of 1.3, a sample size of 20 subjects would provide 90% power to detect a mean change of 0.942. No information was available concerning the within-subject variability between the arms.|
1726016|NCT00608881|3179087|Superiority or Other||Hazard Ratio (HR)|0.93|||||2-Sided|95.0|0.75|1.15|||||||
1726017|NCT00608881|3179088|Superiority or Other||Hazard Ratio (HR)|0.99|||||2-Sided|95.0|0.81|1.2|||||||
1726018|NCT00608881|3179089|Superiority or Other||Mean Difference (Net)|1.04|||||2-Sided|95.0|-1.1|3.18|||||||
1726019|NCT00608881|3179090|Superiority or Other||Mean Difference (Net)|3.88|||||2-Sided|95.0|0.31|7.44|||||||
1726020|NCT00608881|3179091|Superiority or Other||Mean Difference (Final Values)|0.29|||||2-Sided|95.0|-2.28|2.87|||||||
1726021|NCT00608881|3179092|Superiority or Other||Mean Difference (Net)|-0.6|||||2-Sided|95.0|-2.71|1.51|||||||
1726022|NCT00608881|3179093|Superiority or Other||Mean Difference (Net)|0.41|||||2-Sided|95.0|-1.32|2.14|||||||
1726023|NCT00608881|3179094|Superiority or Other||Mean Difference (Net)|-0.77|||||2-Sided|95.0|-4.78|3.23|||||||
1726024|NCT00608881|3179095|Superiority or Other||Mean Difference (Net)|-0.04|||||2-Sided|95.0|-1.48|1.39|||||||
1726025|NCT00608881|3179096|Superiority or Other||Mean Difference (Net)|-1.12|||||2-Sided|95.0|-4.4|2.16|||||||
1726026|NCT00608881|3179097|Superiority or Other||Mean Difference (Net)|-1.44|||||2-Sided|95.0|-6.68|3.79|||||||
1726027|NCT00608881|3179098|Superiority or Other||Mean Difference (Net)|0.09|||||2-Sided|95.0|-1.4|1.58|||||||
1726028|NCT00608881|3179099|Superiority or Other||Mean Difference (Net)|0.23|||||2-Sided|95.0|-0.44|0.91|||||||
1726029|NCT00608881|3179100|Superiority or Other||π hat|0.494|||||2-Sided|95.0|0.454|0.534|||||π hat is the estimate of the probability π that a randomly selected subject treated with CoQ has a better outcome than a randomly selected subject treated with placebo. Under the null hypothesis of no effect of CoQ, π = 0.50.|In this joint rank analysis, subjects are ranked from worst to best outcome with subjects who die being assigned the worst ranks (and ranked according to the time of death) and subjects who survive being ranked more favorably in the order of the change from baseline to Month 60 in TFC score.|
1726030|NCT00608842|3179111|Superiority or Other||Difference to placebo|2.5|||||2-Sided|95.0|-22.3|29.5||||||≥ 75% Cleared|
1726031|NCT00608842|3179111|Superiority or Other||Difference to placebo|-5.1|||||2-Sided|95.0|-28.3|19.6||||||≥ 75% Cleared|
1726032|NCT00608842|3179111|Superiority or Other||Difference to placebo|1.6|||||2-Sided|95.0|-23.0|27.5||||||≥ 75% Cleared|
1726033|NCT00608842|3179111|Superiority or Other||Difference to placebo|7.1|||||2-Sided|95.0|-12.2|31.5||||||Complete Clearance|
1726034|NCT00608842|3179111|Superiority or Other||Difference to placebo|0.0|||||2-Sided|95.0|-18.4|20.4||||||Complete Clearance|
1726035|NCT00608842|3179111|Superiority or Other||Difference to placebo|0.0|||||2-Sided|95.0|-18.4|20.4||||||Complete Clearance|
1726036|NCT00608634|3179115|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1726037|NCT00608634|3179116|Superiority or Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)||||
1726038|NCT00608634|3179116|Superiority or Other|||||||0.1|||||||Wilcoxon (Mann-Whitney)||||
1726039|NCT00608582|3179117|Superiority or Other||||||<|0.835||||||p<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).|
1726040|NCT00608582|3179117|Superiority or Other||||||<|0.822||||||p<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).|
1726041|NCT00608582|3179117|Superiority or Other||||||<|0.414||||||p<0.05 considered significant|ANOVA|||A repeated measures ANOVA is performed with a significance level of p<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).|
1726042|NCT00608582|3179118|Superiority or Other||||||<|0.237||||||p<0.05 considered significant. Pairwise comparisons were not corrected for multiple comparisons.|t-test, 2 sided|||Paired, t-tests were performed if the ANOVA yields a significant interaction (p<0.05, two-sided) for Baseline vs. 2 Mo. after last Sham rTMS treatment.|
1726043|NCT00608582|3179118|Superiority or Other||||||<|0.05||||||p<.05 considered significant; Pairwise comparisons not adjusted for multiple comparisons|t-test, 2 sided|||Paired, t-tests were performed if the ANOVA yields a significant interaction (p<0.05, two-sided) for Baseline vs. 2 months after last rTMS treatment.|
1726044|NCT00608582|3179118|Superiority or Other||||||<|0.028||||||p<0.05 considered significant|ANOVA|Post-hoc paired t-tests were performed.||A repeated measures ANOVA is performed with a significance level of p<0.05 (two-sided). Factors: Time (Baseline vs. 2 Mo. Post rTMS treatment) and Group (Real vs. Sham).|
1726045|NCT00608569|3179126|Superiority or Other|||||||0.133||||||Results were considered to be statistically significant if p<0.05|Fisher Exact|||Fisher exact test (unstratified)|
1726046|NCT00608530|3179134|Superiority or Other|||||||0.05|||||||Fisher Exact||||
1726047|NCT00608530|3179136|Superiority or Other||||||>|0.05|||||||ANOVA|||Repeated measures analysis of variance comparing groups at baseline and end of treatment.|
1726048|NCT00608530|3179137|Superiority|||||||0.05|||||||ANOVA|||Primary analyses consisted of modified intent-to-treat analysis of all randomized participants who attended at least 1 treatment session, with multiple imputation to address missing data. The study was powered at 80% to detect large effect sizes (>.50SD) and alpha of .05 with a recruitment goal N = 140; with the N = 61 actually obtained, our a priori power was .55 to detect between group differences.|
1726049|NCT00608530|3179138|Superiority or Other|||||||0.05|||||||ANOVA|||Repeated measures analysis of variance compared differences between and within groups (CBT and Supportive Care) from baseline to end of treatment. Statistical testing was performed using 2-tailed tests and alpha level of .05 for declaring statistical significance. The trial was powered at the >.80 level to detect differences between condition based on projected sample N = 130; given the N = 66 actually achieved our a priori power for detecting differences between groups was .63.|
1726050|NCT00608426|3179218|Superiority or Other|||||||0.13|||||||Regression, Logistic||||
1726051|NCT00608426|3179219|Superiority or Other|||||||0.002||||||for the comparison of received VA smoking cessation medication between the two groups|Mixed effects logistic regression||||
1726052|NCT00608426|3179219|Superiority or Other|||||||0.77||||||for the comparison of attended VA smoking cessation clinic between the two groups|Mixed effects logistic regression||||
1726053|NCT00608426|3179219|Superiority or Other||||||<|0.001||||||for the comparison of combination counseling and medication between the two groups|Mixed effects logistic regression||||
1726054|NCT00608426|3179219|Superiority or Other||||||<|0.15||||||for the comparison of used medications between the two groups|Mixed effects logistic regression||||
1726055|NCT00608426|3179219|Superiority or Other||||||<|0.57||||||for the comparison of in-person counseling between the two groups|Mixed effects logistic regression||||
1726056|NCT00608426|3179219|Superiority or Other||||||<|0.001||||||for the comparison of telephone counseling between the two groups|Mixed effects logistic regression||||
1726057|NCT00608426|3179220|Superiority or Other|||||||0.02|||||||Regression, Logistic||||
1726058|NCT00608322|3179222|Superiority or Other||Median Difference (Net)|0.03||||0.37|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1726059|NCT00608023|3179278|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1726060|NCT00608023|3179279|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1726061|NCT00608023|3179280|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1726062|NCT00608023|3179281|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1726063|NCT00608023|3179282|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1726064|NCT00607919|3179317|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1726065|NCT00607893|3179318|Other||Mean Difference (Final Values)|6.93|||<|0.001|2-Sided|95.0|3.04|10.81|||Regression, Linear||||
1726066|NCT00607893|3179319|Other||Mean Difference (Final Values)|1.35||||0.59|2-Sided|95.0|-3.6|6.31|||Regression, Linear||||
1726067|NCT00607893|3179320|Other||Mean Difference (Final Values)|0.17||||0.68|2-Sided|95.0|-0.64|0.99|||Regression, Linear||||
1726068|NCT00607893|3179321|Other||Mean Difference (Final Values)|0.062||||0.019|2-Sided|95.0|0.01|0.11|||Regression, Linear||sIL-6R was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.||
1726069|NCT00607893|3179322|Other||Mean Difference (Final Values)|2.4||||0.076|2-Sided|95.0|-0.26|5.07|||Regression, Linear||||
1726070|NCT00607893|3179323|Other||Mean Difference (Final Values)|0.38||||0.17|2-Sided|95.0|-0.16|0.92|||Regression, Linear||||
1726071|NCT00607893|3179324|Other||Mean Difference (Final Values)|0.21||||0.55|2-Sided|95.0|-0.48|0.91|||Regression, Linear||||
1726072|NCT00607893|3179325|Other||Mean Difference (Final Values)|0.14||||0.92|2-Sided|95.0|-2.6|2.87|||Regression, Linear||||
1726073|NCT00607893|3179326|Other||Mean Difference (Final Values)|1.83||||0.85|2-Sided|95.0|-17.42|21.07|||Regression, Linear||||
1726074|NCT00607893|3179327|Other||Mean Difference (Final Values)|0.071||||0.38|2-Sided|95.0|-0.09|0.23|||Regression, Linear||F2-isoprostanes/Cr was log-transformed before analysis. The estimation parameter shows the log-transformed mean difference of the absolute change between groups, while the least square means of two groups are transformed back for presentation.||
1726165|NCT00606580|3179502|Superiority or Other|||||||0.005|||||||Chi-squared||||
1726251|NCT00604279|3179820|Superiority or Other||Least Square Mean Difference|3.4|Standard Error of the Mean|2.08||||95.0|-0.67|7.5||||||Statistical Analysis for Quality of sleep|
1726075|NCT00607789|3179344|Superiority or Other||Mean Difference (Final Values)|4.3|Standard Deviation|1.7|<|0.05|2-Sided|95.0|||||t-test, 2 sided|||The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups. The same analysis was applied to binge episode frequency, weight, BMI, and scores on the CGI-Severity, YBOCS-BE, and IDS scales. The difference in rate of change was estimated by random regression methods|
1726076|NCT00607672|3179361|Superiority or Other|||||||0.46|||||||Mixed Models Analysis||||
1726077|NCT00607672|3179362|Superiority or Other|||||||0.97|||||||Mixed Models Analysis||||
1726078|NCT00607672|3179363|Superiority or Other|||||||0.69|||||||Mixed Models Analysis||||
1726079|NCT00607672|3179364|Superiority or Other|||||||0.04|||||||Kruskal-Wallis||||
1726080|NCT00607672|3179365|Superiority or Other|||||||0.87|||||||Chi-squared||||
1726081|NCT00607672|3179366|Superiority or Other|||||||0.51|||||||Chi-squared||||
1726082|NCT00607672|3179367|Superiority or Other|||||||0.62|||||||Chi-squared||||
1726083|NCT00607672|3179368|Superiority or Other|||||||0.27||||||Comparison for norepinephrine use|Chi-squared||||
1726084|NCT00607672|3179369|Superiority or Other|||||||0.04||||||For plasma transfusion comparison. Ramipril and Candesartan versus placebo|Chi-squared||||
1726085|NCT00607672|3179370|Superiority or Other|||||||0.73|||||||Chi-squared||||
1726086|NCT00607672|3179371|Superiority or Other|||||||0.67|||||||Kruskal-Wallis||||
1726087|NCT00607672|3179372|Superiority or Other|||||||0.84|||||||Mixed Models Analysis||||
1726088|NCT00607672|3179373|Superiority or Other|||||||0.28|||||||Mixed Models Analysis||||
1726089|NCT00607620|3179374|Superiority||Mean Difference (Net)|-0.01|||||2-Sided|95.0|-1.02|0.99|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.||
1726090|NCT00607620|3179375|Superiority||Mean Difference (Net)|-0.7|||||2-Sided|95.0|-3.3|1.9|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.||
1726091|NCT00607620|3179376|Superiority||Mean Difference (Net)|3.4|||||2-Sided|95.0|0.4|6.4|||||The data represented refers to the group mean difference (intervention versus control) of the change score between 6-months and 12-months.||
1726092|NCT00607620|3179377|Superiority||Mean Difference (Net)|-1.2|||||2-Sided|95.0|-2.1|-0.3|||||The data represented refers to the group mean difference (intervention versus control) of the change score between baseline to 12-months.||
1726093|NCT00607620|3179378|Superiority||Risk Ratio (RR)|0.88|||||2-Sided|95.0|0.79|0.98|||||||
1726094|NCT00607373|3179400|Superiority or Other|||||||0.035||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test||||
1726095|NCT00607373|3179402|Superiority or Other|||||||0.328||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided||||
1726096|NCT00607373|3179404|Superiority or Other||||||<|0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided||||
1726097|NCT00607373|3179406|Superiority or Other|||||||0.009||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test||||
1726098|NCT00607373|3179408|Superiority or Other|||||||0.001||||||Statistical significance was concluded if p ≤0.05|t-test, 2 sided||||
1726099|NCT00607373|3179410|Superiority or Other|||||||0.013||||||Statistical significance was concluded if p ≤0.05|Wilcoxon rank sum test||||
1726100|NCT00607373|3179412|Superiority or Other||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in total cholesterol at PET).|t-test, 2 sided||||
1726101|NCT00607373|3179415|Superiority or Other||||||<|0.001||||||Inferential conclusions about this parameter require statistical significance of the previous secondary outcome measure (i.e., percent change from baseline in Apo B at PET).|t-test, 2 sided||||
1726102|NCT00607373|3179417|Superiority or Other||||||<|0.001||||||Inflation of type 1 error was controlled by specifying a small number of secondary parameters and a sequential inferential approach in which inferential conclusions about each successive parameter required statistical significance of the prior one.|t-test, 2 sided||||
1726103|NCT00607373|3179418|Superiority or Other||||||<|0.001||||||Statistical significance was concluded if p≤0.05|t-test, 2 sided|||Based upon prior clinical study experience with mipomersen, it was estimated that the standard deviation of the percent change in LDL-C is approximately 22%. With 15 patients in the control group and 30 patients in the mipomersen-treated group, this study would have at least 80% power to detect a 20 percentage point difference between the 2 treatment groups. Fifty-one patients were enrolled to allow for patient withdrawals and potential exclusions from analysis sets.|
1726104|NCT00607087|3179439|Superiority or Other|||||||0.938||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|ANCOVA|ANCOVA adjusted on HbA1c level at the start of the first period|||
1726105|NCT00607087|3179439|Superiority or Other|||||||0.078||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|ANCOVA|ANCOVA adjusted on HbA1c value at the start of the first period|||
1726106|NCT00607087|3179442|Superiority or Other|||||||0.701||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|McNemar||||
1726107|NCT00607087|3179442|Superiority or Other|||||||1||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|McNemar||||
1726108|NCT00607087|3179443|Superiority or Other||||||<|0.001||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|Mixed Models Analysis||||
1726543|NCT00596934|3180804|Superiority or Other|||||||0.074||||||p = 0.074|t-test, 2 sided||||
1726109|NCT00607087|3179443|Superiority or Other||||||<|0.001||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|Mixed Models Analysis||||
1726110|NCT00607087|3179444|Superiority or Other|||||||0.186||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|Mixed Models Analysis||||
1726111|NCT00607087|3179444|Superiority or Other|||||||0.563||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|Mixed Models Analysis||||
1726112|NCT00607087|3179445|Superiority or Other||||||<|0.001||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|Mixed Models Analysis||||
1726113|NCT00607087|3179445|Superiority or Other||||||<|0.008||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|Mixed Models Analysis||||
1726114|NCT00607087|3179446|Superiority or Other|||||||0.019||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|Mixed Models Analysis||||
1726115|NCT00607087|3179446|Superiority or Other|||||||0.009||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|Mixed Models Analysis||||
1726116|NCT00607087|3179447|Superiority or Other|||||||0.032||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|McNemar||||
1726117|NCT00607087|3179447|Superiority or Other|||||||0.017||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|McNemar||||
1726118|NCT00607087|3179448|Superiority or Other|||||||0.073||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|Mixed Models Analysis||||
1726119|NCT00607087|3179448|Superiority or Other|||||||0.015||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|Mixed Models Analysis||||
1726120|NCT00607087|3179449|Superiority or Other|||||||0.063||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|McNemar||||
1726121|NCT00607087|3179449|Superiority or Other|||||||0.079||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|McNemar||||
1726122|NCT00607087|3179450|Superiority or Other||||||<|0.001||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|McNemar||||
1726123|NCT00607087|3179450|Superiority or Other||||||<|0.001||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|Mixed Models Analysis||||
1726124|NCT00607087|3179451|Superiority or Other|||||||0.107||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|McNemar||||
1726125|NCT00607087|3179451|Superiority or Other|||||||0.08||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|McNemar||||
1726126|NCT00607087|3179452|Superiority or Other||||||<|0.001||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|Mixed Models Analysis||||
1726127|NCT00607087|3179452|Superiority or Other||||||<|0.001||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|Mixed Models Analysis||||
1726128|NCT00607087|3179453|Superiority or Other|||||||0.031||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025.|McNemar||||
1726129|NCT00607087|3179453|Superiority or Other|||||||0.039||||||The p-value is adjusted for multiple comparisons. Each comparison is performed at the alpha level=2.5% (instead of 5%). Consequently a difference between 2 treatments is statistically significant if the corresponding p-value is <0.025|McNemar||||
1726130|NCT00607022|3179467|Other|Kruskal-Wallis values between each loading group and for Wilcoxon Signed Rank for measures on the mesial vs buccal side of the implant.|||||>|0.05||||||0.0501 < p < 0.9797|Kruskal-Wallis|Kruskal-Wallis test evaluated ISQ at each time point..||Comparison between loading groups at 16 weeks - loading at baseline, Loading at 6 weeks, and loading at 12 weeks. Scores for all groups were compared at 16 weeks from implant placement..|
1726544|NCT00596934|3180805|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1726132|NCT00606892|3179482|Superiority or Other||||||<|0.05||||||Post hoc comparisons of effects of varenicline versus placebo for different nicotine doses were performed and significance was adjusted for multiple testing using a p value of P<0.016|ANOVA|Two-tailed tests were applied for main effects with P<0.05||A mixed-effect, repeated-measures, crossover model was used with fixed main effects for treatment (placebo or varenicline), and time after treatment. Interactions between main effects were also analyzed.|
1726133|NCT00606892|3179483|Superiority or Other||Mean Difference (Final Values)|0.0|||<|0.05|2-Sided|95.0||||Values of p<0.05 were considered statistically significant, based on 2-tailed tests. Significant treatment, or treatment-by-time interactions were followed by post hoc comparisons. To account for multiple testing, significance was set at p<0.016.|Mixed Models Analysis|||A mixed-effect repeated-measures crossover model including fixed main effects for treatment condition (placebo or varenicline), time of measurement and interactions between treatment and time, was utilized. Because multiple measurements were collected before and after each nicotine dose, a change score (maximum post dose score - pre dose baseline) was used in the analysis.|
1726134|NCT00606892|3179484|Superiority or Other||Mean Difference (Final Values)|17.0|Standard Deviation|40.0|<|0.3|2-Sided|95.0|||||ANOVA|F(1,10)=1.1|||
1726135|NCT00606892|3179485|Superiority or Other||||||<|0.05||||||Significant treatment or treatment-by-time interactions were followed up by post hoc comparisons of placebo vs. varenicline for time (Pre- vs. Post-Nicotine infusion) and testing block (Smoking Block vs. Negative Affect Block).|Mixed Models Analysis|||A mixed-effect repeated-measures crossover model with fixed main effect terms of treatment (placebo or varenicline) and time of measurement (Pre-Nicotine or Post-Nicotine) was utilized. Interactions between main effect terms were also analyzed.|
1726136|NCT00606801|3179486|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.|
1726137|NCT00606801|3179487|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.|
1726138|NCT00606801|3179488|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||A mixed-effect, repeated-measures model using main effect terms of treatment (placebo or galantine) and time (day of measurement). Interaction of main effects were also analyzed, with a random effect for participant. Given the hypothesis generating nature of the study, values of p<0.05 were considered statistically significant based on two-tailed tests. Significant interactions were followed by Bonferroni post hoc pairwise comparisons.|
1726139|NCT00606684|3179492|Superiority or Other||Least squares mean difference|0.165|||<|0.001|2-Sided|95.0|0.112|0.217|||ANCOVA||||
1726140|NCT00606684|3179492|Superiority or Other||Least squares mean difference|0.137|||<|0.001|2-Sided|95.0|0.085|0.19|||ANCOVA||||
1726141|NCT00606684|3179492|Superiority or Other||Least squares mean difference|0.11|||<|0.001|2-Sided|95.0|0.057|0.162|||ANCOVA||||
1726142|NCT00606684|3179492|Superiority or Other||Least squares mean difference|0.098|||<|0.001|2-Sided|95.0|0.046|0.15|||ANCOVA||||
1726143|NCT00606684|3179492|Superiority or Other||Least squares mean difference|0.092|||<|0.001|2-Sided|95.0|0.039|0.144|||ANCOVA||||
1726144|NCT00606632|3179496|Superiority||||||<|0.01|||||||McNemar||||
1726145|NCT00606632|3179496|Superiority||||||<|0.023|||||||McNemar||||
1726146|NCT00606593|3179497|Superiority or Other||Least square means treatment effect|55.1|||<|0.0001|2-Sided|95.0|48.2|62.0|||Linear model||||
1726147|NCT00606593|3179497|Superiority or Other||Least square means treatment effect|34.7|||<|0.0001|2-Sided|95.0|27.8|41.6|||Linear model||||
1726148|NCT00606593|3179497|Superiority or Other||Least square means treatment effect|21.5|||<|0.0001|2-Sided|95.0|14.6|28.4|||Linear model||||
1726149|NCT00606593|3179497|Superiority or Other||Least square means treatment effect|14.3|||<|0.0001|2-Sided|95.0|7.4|21.2|||Linear model||||
1726150|NCT00606593|3179498|Superiority or Other||Least square means treatment effect|-46.5|||<|0.0001|2-Sided|95.0|-53.3|-39.9|||Linear model||||
1726151|NCT00606593|3179498|Superiority or Other||Least square means treatment effect|-31.4|||<|0.0001|2-Sided|95.0|-38.0|-24.9|||Linear model||||
1726152|NCT00606593|3179498|Superiority or Other||Least square means treatment effect|-19.2|||<|0.0001|2-Sided|95.0|-25.7|-12.6|||Linear model||||
1726153|NCT00606593|3179498|Superiority or Other||Least square means treatment effect|-10.4|||<|0.0018|2-Sided|95.0|-17.0|-3.9|||Linear model||||
1726154|NCT00606580|3179499|Non-Inferiority or Equivalence|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p < .05.||||||0.701|||||||Chi-squared||||
1726155|NCT00606580|3179499|Superiority or Other|||||||0.651|||||||Chi-squared||||
1726156|NCT00606580|3179499|Superiority or Other|||||||0.409|||||||Chi-squared||||
1726157|NCT00606580|3179500|Non-Inferiority or Equivalence|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p < .05.||||||0.247|||||||Chi-squared||||
1726158|NCT00606580|3179500|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1726159|NCT00606580|3179500|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1726160|NCT00606580|3179501|Non-Inferiority or Equivalence|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p < .05.||||||0.893|||||||Chi-squared||||
1726161|NCT00606580|3179501|Superiority or Other|||||||0.002|||||||Chi-squared||||
1726162|NCT00606580|3179501|Superiority or Other|||||||0.003|||||||Chi-squared||||
1726163|NCT00606580|3179502|Non-Inferiority or Equivalence|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p < .05.||||||1|||||||Chi-squared||||
1726166|NCT00606580|3179503|Non-Inferiority or Equivalence|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p < .05.||||||0.725|||||||Chi-squared||||
1726167|NCT00606580|3179503|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1726168|NCT00606580|3179503|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1726169|NCT00606580|3179508|Non-Inferiority or Equivalence|The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p < .05.||||||0.83|||||||Log Rank||||
1726170|NCT00606580|3179508|Superiority or Other|||||||0.275|||||||Log Rank||||
1726171|NCT00606580|3179508|Superiority or Other|||||||0.33|||||||Log Rank|Mantel-Cox (log-rank) grouped failure time test using proportion re-epithelialized at each of the scheduled assessments through Day 42 without relapse|||
1726172|NCT00606580|3179509|Non-Inferiority or Equivalence|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p < .05.||||||0.767|||||||Chi-squared||||
1726173|NCT00606580|3179509|Superiority or Other|||||||0.0002|||||||Chi-squared||||
1726174|NCT00606580|3179509|Superiority or Other|||||||0.0006|||||||Chi-squared||||
1726175|NCT00606580|3179510|Non-Inferiority or Equivalence|Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p < .05.||||||0.871|||||||Chi-squared|||H02: There is no difference in clinical cure between WR 279,396 and Paromomycin Alone. Test of H02: If H01 was rejected, then H02 would be tested. The comparison of WR 279,396 versus Paromomycin Alone would be considered statistically significant if p < .05.|
1726176|NCT00606580|3179510|Superiority or Other||||||<|0.0001|||||||Chi-squared|||H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.|
1726177|NCT00606580|3179510|Superiority or Other||||||<|0.0001|||||||Chi-squared|||H01: There is no difference in the final clinical cure rate between WR 279,396 and Vehicle AND there is no difference in the final clinical cure rate between Paromomycin Alone and Vehicle.|
1726178|NCT00606554|3179511|Superiority or Other|||||||0.9|||||||Chi-squared||||
1726179|NCT00606554|3179514|Superiority or Other|||||||0.06|||||||Chi-squared||||
1726180|NCT00606554|3179518|Superiority or Other|||||||0.6|||||||Wilcoxon (Mann-Whitney)||||
1726181|NCT00606502|3179522|Superiority or Other||Cox Proportional Hazard|0.84|||||2-Sided|95.0|0.61|1.14|||||||
1726182|NCT00606281|3179529|Superiority or Other||Mean Difference (Final Values)|-0.7|||<|0.001||95.0|-1.1|-0.3|||ANCOVA||||
1726183|NCT00606281|3179530|Superiority or Other||Mean Difference (Final Values)|-6.0|||<|0.001|2-Sided|95.0|-9.4|-2.7|||ANCOVA||||
1726184|NCT00606086|3179542|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel test||||
1726185|NCT00606021|3179549|Superiority or Other||Hazard Ratio (HR)|1.18||||0.6376|2-Sided|95.0|0.59|2.38||The significant level for the secondary outcome measure overall survival during overall period is two-sided 0.05.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.|||
1726186|NCT00606021|3179550|Superiority or Other||Hazard Ratio (HR)|1.13||||0.7239|2-Sided|95.0|0.56|2.28||The significant level for the secondary outcome measure overall survival during maintenance period is two-sided 0.05.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.|||
1726187|NCT00606021|3179551|Superiority or Other||Hazard Ratio (HR)|0.71||||0.1233|2-Sided|95.0|0.4|1.26||The significant level for the secondary outcome measure of progression free survival during overall period is one-sided 0.2.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.|||
1726188|NCT00606021|3179552|Superiority or Other||Hazard Ratio (HR)|0.76||||0.1815|2-Sided|95.0|0.42|1.37||The significant level for the primary outcome measure of progression free survival during maintenance phase is one-sided 0.2.|Regression, Cox|Stratified Cox regression model is used for hazard ratio estimate. Stratification factor: response status prior to randomization.|||
1726189|NCT00605917|3179556|Superiority or Other|||||||0.004||||||not adjusted, p=0.050|Chi-squared|||"The factor tested was drinking status. The null hypothesis is there is no difference between five types of drinking status in the participants of responders."|
1726190|NCT00605917|3179557|Superiority or Other|||||||0.004||||||not adjusted, p=0.050|Chi-squared|||"The factor tested was complications. The null hypothesis is there is no difference between with or without complications in the participants of responders."|
1726191|NCT00605917|3179558|Superiority or Other|||||||0.013||||||not adjusted, p=0.050|Chi-squared|||"The factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."|
1726192|NCT00605917|3179559|Superiority or Other|||||||0.03||||||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."|Chi-squared|not adjusted, p=0.050||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."|
1726193|NCT00605917|3179560|Superiority or Other||||||<|0.001||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was average daily dose. The null hypothesis is there is no difference of five types of average daily dose in the participants of responders."|
1726194|NCT00605917|3179561|Superiority or Other|||||||0.028||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was history of treatment prior to administration of Sertraline. The null hypothesis is there is no difference between with and without history of treatment prior to administration of Sertraline in the participants of responders."|
1726195|NCT00605917|3179562|Superiority or Other|||||||0.001||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with and without non-pharmaceutical therapies in the participants of responders."|
1726250|NCT00604279|3179820|Superiority or Other||Least Square Mean Difference|-1.1|Standard Error of the Mean|2.02||||95.0|-5.04|2.9||||||Statistical Analysis for Daytime drowsiness|
1726196|NCT00605917|3179563|Superiority or Other||||||<|0.001||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."|
1726197|NCT00605917|3179564|Superiority or Other||||||<|0.001||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was smoking status. The null hypothesis is there is no difference between three types of smoking status in the participants of responders."|
1726198|NCT00605917|3179565|Superiority or Other|||||||0.032||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was family history of psychiatric disorder. The null hypothesis is there is no difference between with and without family history of psychiatric disorder in the participants of responders."|
1726199|NCT00605917|3179566|Superiority or Other|||||||0.002||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."|
1726200|NCT00605917|3179567|Superiority or Other||||||<|0.001||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was starting dose. The null hypothesis is there is no difference between three types of starting dose in the participants of responders."|
1726201|NCT00605865|3179573|Superiority or Other||||||<|0.001||||||not adjusted, p=0.050|Chi-squared|||"The factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with or without suicidal ideation (including suicide attempt) in the participants of responders."|
1726202|NCT00605865|3179574|Superiority or Other|||||||0.015||||||not adjusted, p=0.050|Chi-squared|||"The factor tested was age. The null hypothesis is there is no difference between four groups of age in the participants of responders."|
1726203|NCT00605865|3179575|Superiority or Other|||||||0.01||||||not adjusted, p=0.050|Chi-squared|||"The factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders."|
1726204|NCT00605865|3179576|Superiority or Other|||||||0.019||||||not adjusted, p=0.050|Chi-squared|||"The factor tested was complications. The null hypothesis is there is no difference between with or without complications in the participants of responders."|
1726205|NCT00605865|3179577|Superiority or Other|||||||0.012||||||not adjusted, p=0.050|Chi-squared|||"The factor tested was outpatient or inpatient. The null hypothesis is there is no difference between outpatient or inpatient in the participants of responders."|
1726206|NCT00605865|3179578|Superiority or Other|||||||0.003||||||not adjusted, p=0.050|Chi-squared|||"The factor tested was history of treatment prior to Sertralin. The null hypothesis is there is no difference between with and without history of treatment prior to Sertralin in the participants of responders."|
1726207|NCT00605865|3179579|Superiority or Other||||||<|0.001||||||not adjusted, p=0.050|Chi-squared|||"The factor tested was target disease severity. The null hypothesis is there is no difference between three grade of target disease severity in the participants of responders."|
1726208|NCT00605865|3179580|Superiority or Other|||||||0.021||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was 15 years and higher of age or not. The null hypothesis is there is no difference between 15 years and higher of age or not in the participants of responders."|
1726209|NCT00605865|3179581|Superiority or Other|||||||0.014||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was suicidal ideation (including suicide attempt). The null hypothesis is there is no difference between with and without suicidal ideation(including suicide attempt) in the participants of responders."|
1726210|NCT00605865|3179582|Superiority or Other||||||<|0.001||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was average daily dose. The null hypothesis is there is no difference of five types of average daily dose in the participants of responders."|
1726211|NCT00605865|3179583|Superiority or Other|||||||0.01||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."|
1726212|NCT00605865|3179584|Superiority or Other|||||||0.011||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders."|
1726213|NCT00605865|3179585|Superiority or Other|||||||0.039||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was concomitant drug. The null hypothesis is there is no difference between with and without concomitant drug in the participants of responders."|
1726214|NCT00605865|3179586|Superiority or Other||||||<|0.001||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was complications. The null hypothesis is there is no difference between with and without complications in the participants of responders."|
1726215|NCT00605813|3179590|Superiority or Other|||||||0.004||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was present or past history of intentional suicidal ideation. The null hypothesis is there is no difference between present or past history of intentional suicidal ideation (including suicide attempt) in the participants of responders."|
1726216|NCT00605813|3179591|Superiority or Other|||||||0.04||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was non-pharmaceutical therapies. The null hypothesis is there is no difference between with or without non-pharmaceutical therapies in the participants of responders."|
1726217|NCT00605813|3179592|Superiority or Other||||||<|0.001||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was past medical history of other illness. The null hypothesis is there is no difference between with and without past medical history of other illness in the participants of responders."|
1726218|NCT00605813|3179593|Superiority or Other|||||||0.003||||||not adjusted, p=0.050|Chi-squared|||"The risk factor tested was renal dysfunction. The null hypothesis is there is no difference between with and without renal dysfunction in the participants of responders."|
1726219|NCT00605540|3179616|Superiority or Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||All data were analyzed using SigmaStat 3.2 (Inc., USA) software. Mean ± SD or median interquartile range (25-75%) was used depending on the data distribution. Wilcoxon test was applied to compare the characteristics at baseline to those observed after 3 years.|
1726252|NCT00604279|3179821|Superiority or Other||Least Square Mean Difference|-0.1|Standard Error of the Mean|0.11||||95.0|-0.33|0.1|||||||
1726220|NCT00605358|3179648|Superiority or Other||Odds Ratio (OR)|2.4||||0.018|2-Sided|95.0|1.17|4.93|||Chi-squared|||Participants in the Open Door Intervention and the Services Referral condition were compared on rates of engagement in mental health services over the study follow-up period.|
1726221|NCT00605345|3179654|Non-Inferiority or Equivalence|Non-inferiority was met if the lower limit of the confidence interval for the response rate of the CERA group was greater than the observed response rate of the darbepoetin group minus 15%. The calculated lower limit of an acceptable difference in response rates thus, was based on the actual percentage of “responders“ in the darbepoetin group and this percentage minus 15% had to be excluded.||||||0.5947|||||||Fisher Exact||||
1726222|NCT00605293|3179671|Superiority or Other|||||||0.4778|||||||Fisher Exact||||
1726223|NCT00605280|3179672|Superiority or Other||Odds Ratio (OR)|0.4||||0.0008|2-Sided|95.0|0.23|0.69|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.|||
1726224|NCT00605280|3179673|Superiority or Other||Odds Ratio (OR)|0.42||||0.0023|2-Sided|95.0|0.24|0.74|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.|||
1726225|NCT00605280|3179674|Superiority or Other||LS Mean|4.57||||0.0011|2-Sided|95.0|1.85|7.29|||ANCOVA|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post baseline data.|||
1726226|NCT00605280|3179675|Superiority or Other||Least Squares (LS) Mean|3.9||||0.004|2-Sided|95.0|1.25|6.54|||ANCOVA|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.|||
1726227|NCT00605280|3179676|Superiority or Other||Odds Ratio (OR)|5.12||||0.0048|2-Sided|95.0|1.45|18.06|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.|||
1726228|NCT00605280|3179677|Superiority or Other||Odds Ratio (OR)|0.48||||0.1788|2-Sided|95.0|0.16|1.42|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.|||
1726229|NCT00605280|3179678|Superiority or Other||Odds Ratio (OR)|2.9||||0.1124|2-Sided|95.0|0.73|11.55|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.|||
1726230|NCT00605280|3179679|Superiority or Other||Odds Ratio (OR)|0.27||||0.0468|2-Sided|95.0|0.07|0.99|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.|||
1726231|NCT00605280|3179680|Superiority or Other||Odds Ratio (OR)|1.67||||0.1388|2-Sided|95.0|0.86|3.26|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.|||
1726232|NCT00605280|3179681|Superiority or Other||Odds Ratio (OR)|1.57||||0.2466|2-Sided|95.0|0.74|3.34|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.|||
1726233|NCT00605280|3179682|Superiority or Other||Odds Ratio (OR)|1.46||||0.1904|2-Sided|95.0|0.85|2.53|||Cochran-Mantel-Haenszel|Adjusted for HbA1c, systolic BP, diastolic BP, and baseline VA. Baseline values were not carried forward for any missing post-baseline data.|||
1726234|NCT00605280|3179683|Superiority or Other||Odds Ratio (OR)|2.38||||0.0047|2-Sided|95.0|1.32|4.3||Adjusted for glycolated hemoglobin (HbA1c), systolic blood pressure (BP), diastolic BP, and baseline VA. Baseline values not carried forward for missing post-baseline data.|Cochran-Mantel-Haenszel||||
1726235|NCT00605202|3179701|Superiority or Other|||||||0.007||||||P-value of the change in the plasma potassium (baseline to 2 weeks) between arms|t-test, 2 sided|||Statistical analysis applies to the change in the plasma potassium (baseline to 2 weeks) between arms|
1726236|NCT00605072|3179713|Superiority or Other|||||||0.79|||||||Mixed Models Analysis||||
1726237|NCT00605072|3179714|Superiority or Other|||||||0.87|||||||Mixed Models Analysis||||
1726238|NCT00605072|3179715|Superiority or Other|||||||0.81|||||||Mixed Models Analysis|Adjusted for age at baseline|||
1726239|NCT00605072|3179716|Superiority or Other|||||||0.74|||||||Mixed Models Analysis|adjusted for age|||
1726240|NCT00605072|3179717|Superiority or Other|||||||0.008||||||p-value for between group comparison (group*visit)|Mixed Models Analysis|Adjusted for baseline AGE and Mini-Mental-State-Examination|||
1726241|NCT00605033|3179718|Non-Inferiority or Equivalence|Non-inferiority was defined as a lower bound of the two-sided 95% confidence interval of the proportion difference greater than -0.15.|Proportion difference|-0.054|||||2-Sided|95.0|-0.142|0.034|||||||
1726242|NCT00604825|3179767|Superiority||Adjusted Mean Difference|-0.52|||<|0.001|2-Sided|95.0|-0.75|-0.3||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. Premarin 0.3 mg|
1726243|NCT00604825|3179767|Superiority||Adjusted Mean Difference|0.31|||<|0.008|2-Sided|95.0|0.08|0.54||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 75 mg|
1726244|NCT00604825|3179767|Superiority||Adjusted Mean Difference|0.15|||<|0.202|2-Sided|95.0|-0.08|0.38||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 25 mg|
1726245|NCT00604825|3179768|Superiority||Adjusted Mean Difference|-2.06|||<|0.001|2-Sided|95.0|-3.2|-0.92||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. Premarin 0.3 mg|
1726246|NCT00604825|3179768|Superiority||Adjusted Mean Difference|1.21|||<|0.041|2-Sided|95.0|0.05|2.37||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 75 mg|
1726247|NCT00604825|3179768|Superiority||Adjusted Mean Difference|0.75|||<|0.215|2-Sided|95.0|-0.44|1.93||Analysis included the terms for: Treatment + Baseline + country + uterine strata.|General linear model|||Placebo vs. GSK232802 25 mg|
1726248|NCT00604383|3179818|Superiority or Other|||||||0.034|||||||Cochran-Mantel-Haenszel||||
1726249|NCT00604279|3179819|Superiority or Other||Point estimate of relative risk|0.9||||||95.0|0.81|1.01|||||||
1726254|NCT00604279|3179823|Non-Inferiority or Equivalence|The predetermined margin for non-inferiority of paliperidone palmitate was 5.5 points|Least Square Mean Difference|-2.3|Standard Error of the Mean|1.48||||95.0|-5.2|0.63|||||||
1726255|NCT00604214|3179824|Superiority or Other|||||||0.154||||||Unadjusted for multiple comparisons.|Fisher Exact||||
1726256|NCT00604214|3179825|Superiority or Other|||||||0.758||||||P-value is for participants with ≥1 event. No adjustments for multiple comparisons.|Fisher Exact||||
1726257|NCT00604214|3179826|Superiority or Other|||||||0.966||||||P-value is for mental component at Day 180, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.|
1726258|NCT00604214|3179826|Superiority or Other|||||||0.696||||||P-value is for mental component at Day 90, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.|
1726259|NCT00604214|3179826|Superiority or Other|||||||0.16||||||P-value is for mental component at Day 28, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.|
1726260|NCT00604214|3179826|Superiority or Other|||||||0.786||||||P-value is for mental component at Baseline, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.|
1726261|NCT00604214|3179826|Superiority or Other|||||||0.666||||||P-value is for physical component at Day 180, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.|
1726262|NCT00604214|3179826|Superiority or Other|||||||0.164||||||P-value is for physical component at Day 90, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.|
1726263|NCT00604214|3179826|Superiority or Other|||||||0.584||||||P-value is for physical component at Day 28, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.|
1726264|NCT00604214|3179826|Superiority or Other|||||||0.482||||||P-value is for physical component at Baseline, unadjusted for multiple comparisons.|ANOVA|||Analysis on ranked data.|
1726265|NCT00604214|3179827|Superiority or Other|||||||0.69||||||P-value is for Day 180, unadjusted for multiple comparisons.|ANOVA||||
1726266|NCT00604214|3179827|Superiority or Other|||||||0.645||||||P-value is for Day 90, unadjusted for multiple comparisons.|ANOVA||||
1726267|NCT00604214|3179827|Superiority or Other|||||||0.306||||||P-value is for Day 28, unadjusted for multiple comparisons.|ANOVA||||
1726268|NCT00604214|3179827|Superiority or Other|||||||0.697||||||P-value is for Baseline, unadjusted for multiple comparisons.|ANOVA||||
1726269|NCT00604214|3179828|Superiority or Other|||||||0.846||||||P-value is for Day 180, unadjusted for multiple comparisons.|ANOVA||||
1726270|NCT00604214|3179828|Superiority or Other|||||||0.662||||||P-value is for Day 90, unadjusted for multiple comparisons.|ANOVA||||
1726271|NCT00604214|3179828|Superiority or Other|||||||0.73||||||P-value is for Day 28, unadjusted for multiple comparisons.|ANOVA||||
1726272|NCT00604214|3179828|Superiority or Other|||||||0.788||||||P-value is for Baseline, unadjusted for multiple comparisons.|ANOVA||||
1726273|NCT00604214|3179830|Superiority or Other||Risk Ratio (RR)|1.02||||0.758|2-Sided|95.0|0.898|1.16||No adjustments for multiple comparisons.|Chi-squared||||
1726274|NCT00604214|3179831|Superiority or Other||Risk Ratio (RR)|1.042||||0.556|2-Sided|95.0|0.909|1.193||No adjustments for multiple comparisons.|Chi-squared||||
1726275|NCT00604214|3179832|Superiority or Other|||||||0.122||||||No adjustments for multiple comparisons.|ANOVA||||
1726276|NCT00604214|3179833|Superiority or Other|||||||0.733||||||No adjustments for multiple comparisons.|ANOVA||||
1726277|NCT00604214|3179834|Superiority or Other|||||||0.181||||||No adjustments for multiple comparisons.|ANOVA||||
1726278|NCT00604214|3179835|Superiority or Other||Risk Ratio (RR)|0.93||||0.54|2-Sided|95.0|0.737|1.173||No adjustments for multiple comparisons.|Chi-squared||||
1726279|NCT00604214|3179836|Superiority or Other||Risk Ratio (RR)|1.088||||0.313|2-Sided|95.0|0.923|1.283||No adjustment for multiple comparisons.|Chi-squared|||The study was planned to have 80% power to detect a 20% relative risk reduction in 28-day all-cause mortality in drotrecogin alpha (activated) compared to placebo. The final power was 75% because of the lower than anticipated placebo mortality.|
1726280|NCT00603902|3179900|Superiority or Other (legacy)||Mean Difference (Final Values)|-3.0|||<|0.0001|2-Sided|95.0|-3.44|-2.56|||ANCOVA||||
1726281|NCT00603902|3179901|Superiority or Other (legacy)||Odds Ratio, log|2.69|||<|0.0001|2-Sided|95.0|2.31|3.13|||Regression, Logistic|Adjustments for baseline body weight.|||
1726282|NCT00603837|3179906|Superiority or Other|||||||0.445|||||||t-test, 1 sided||||
1726283|NCT00603746|3179933|Superiority or Other||Mean Difference (Final Values)|0.198|||<|0.001|2-Sided|95.0|0.105|0.291|||ANCOVA||||
1726284|NCT00603746|3179933|Superiority or Other||Mean Difference (Final Values)|0.225|||<|0.001|2-Sided|95.0|0.131|0.32|||ANCOVA||||
1726285|NCT00603746|3179933|Superiority or Other||Median Difference (Final Values)|0.264|||<|0.001|2-Sided|95.0|0.171|0.357|||ANCOVA||||
1726286|NCT00603746|3179933|Superiority or Other||Median Difference (Final Values)|0.272|||<|0.001|2-Sided|95.0|0.178|0.367|||ANCOVA||||
1726287|NCT00603746|3179933|Superiority or Other||Median Difference (Final Values)|0.275|||<|0.001||95.0|0.18|0.37|||ANCOVA||||
1726288|NCT00603642|3179938|Superiority or Other|||||||0.6015|||||||Fisher Exact||||
1726289|NCT00603642|3179939|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1726290|NCT00603642|3179940|Superiority or Other|||||||0.0003|||||||ANCOVA||||
1726291|NCT00603642|3179941|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1726292|NCT00603642|3179942|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1726293|NCT00603564|3179946|Superiority or Other|||||||7e-06|||||||Chi-squared||||
1726294|NCT00603564|3179947|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||endpoint was analyzed in terms of time by comparison of mean +- SD|
1726295|NCT00603382|3180070|Superiority or Other||Mean Difference (Final Values)|0.106||||0.074|2-Sided|95.0|-0.01|0.223|||ANCOVA||||
1726296|NCT00603382|3180070|Superiority or Other||Mean Difference (Final Values)|0.23|||<|0.001|2-Sided|95.0|0.111|0.349|||ANCOVA||||
1726297|NCT00603382|3180070|Superiority or Other||Median Difference (Final Values)|0.204|||<|0.001|2-Sided|95.0|0.089|0.319|||ANCOVA||||
1726298|NCT00603382|3180070|Superiority or Other||Mean Difference (Final Values)|0.129|||<|0.033|2-Sided|95.0|0.011|0.247|||ANCOVA||||
1726299|NCT00603382|3180070|Superiority or Other||Median Difference (Final Values)|0.101|||<|0.095|2-Sided|95.0|-0.018|0.221|||ANCOVA||||
1726300|NCT00603291|3180086|Superiority or Other (legacy)||Mean Difference (Final Values)|-3.06|||<|0.0001|2-Sided|95.0|-3.92|-2.2|||ANCOVA||||
1726301|NCT00603291|3180087|Superiority or Other (legacy)||Odds Ratio (OR)|3.14|||<|0.0001|2-Sided|95.0|2.05|4.8|||Regression, Logistic|Adjustment for baseline body weight, baseline HbA1c stratum, and prior antihyperglycemic medication stratum|||
1726302|NCT00603278|3180110|Superiority or Other||Mean Difference (Final Values)|0.225|||<|0.001|2-Sided|95.0|0.114|0.337|||ANCOVA||||
1726303|NCT00603278|3180110|Superiority or Other||Mean Difference (Final Values)|0.279|||<|0.001|2-Sided|95.0|0.167|0.392|||ANCOVA||||
1726304|NCT00603278|3180110|Superiority or Other||Mean Difference (Final Values)|0.293|||<|0.001|2-Sided|95.0|0.182|0.404|||ANCOVA||||
1726305|NCT00603278|3180110|Superiority or Other||Mean Difference (Final Values)|0.238|||<|0.001|2-Sided|95.0|0.127|0.349|||ANCOVA||||
1726306|NCT00603278|3180110|Superiority or Other||Mean Difference (Final Values)|0.207|||<|0.001|2-Sided|95.0|0.096|0.318|||ANCOVA||||
1726307|NCT00603239|3180118|Superiority or Other|||||||0.186||||||No adjustments (alpha = 0.05)|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in EQ-5D score is equal between the two treatment groups. This statistical analysis is for the EQ-5D Health State Score only.|
1726308|NCT00603239|3180119|Superiority or Other|||||||0.342||||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in IWQOL-Lite Total Score is equal between the two treatment groups. This statistical analysis is for the Total Score only.|
1726309|NCT00603239|3180120|Superiority or Other|||||||1||||||No adjustments (alpha = 0.05).|Fisher Exact|No adjustment for multiplicity.||Null hypothesis = Incidence of minor hypoglycemia episodes is equal between the two treatment groups.|
1726310|NCT00603239|3180121|Superiority or Other|||||||0.794||||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in HOMA-S is equal between the two treatment groups.|
1726311|NCT00603239|3180122|Superiority or Other|||||||0.009||||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change form baseline in HOMA-B is equal between the two treatment groups.|
1726312|NCT00603239|3180124|Superiority or Other|||||||0.176||||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline to endpoint in body weight is equal between the two treatment groups.|
1726313|NCT00603239|3180125|Superiority or Other|||||||0.009||||||No adjustments (alpha = 0.05).|ANCOVA|No adjustment for multiplicity.||Null hypothesis = Change from baseline in FSG is equal between the two treatment groups.|
1726314|NCT00603239|3180126|Superiority or Other|||||||0.004||||||No adjustments (alpha = 0.05).|CMH test|No adjustment for multiplicity.||Null hypothesis = Proportion of subjects achieving HbA1c <= 6.5% is equal between the two treatment groups.|
1726315|NCT00603239|3180127|Superiority or Other|||||||0.113||||||No adjustments (alpha = 0.05).|CMH test|No adjustment for multiplicity.||Null hypothesis = Proportion of subjects with HbA1c <= 7% is equal between the two treatment groups.|
1726316|NCT00603239|3180128|Superiority or Other||||||<|0.001||||||No adjustments were made (alpha = 0.05).|ANCOVA|No adjustments for multiplicity were made.||Null hypothesis = Change from baseline in HbA1c is equal between the two treatment groups. Greater than 99% power to detect a difference between treatment groups of 0.88% in change in HbA1c from baseline using a 2-sided t-test at a significance level of 0.05.|
1726317|NCT00602797|3180153|Other|An interim analysis was conducted after 10 patients were accrued. Since response rate seen at the first interim analysis was superior to that seen with standard of care, a new monitoring rule was approved. Toxicity monitoring would occur after 19 patients. If 6/19 patients had ≥grade 4 non-hematological toxicity, accrual will be terminated. This will provide 84% power to detect 40% toxicity.|Proportion|6.0|||||2-Sided||||||||If 6/19 patients had ≥grade 4 non-hematological toxicity, accrual will be terminated.|Adverse events will be graded using the NCI Common Toxicity Criteria (version 3.0).|
1726318|NCT00602667|3180218|Other||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.31|1.79||||||The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).|
1726319|NCT00602667|3180218|Other||Hazard Ratio (HR)|1.85|||||2-Sided|95.0|0.42|8.22||||||The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).|
1726320|NCT00602667|3180219|Other||Hazard Ratio (HR)|0.86|||||2-Sided|95.0|0.4|1.84||||||The historical control included 14 medulloblastoma patients treated during 1998-2006 who would have been classified as high risk according to SJYC07 criteria (section 13.1.3 of protocol).|
1726321|NCT00602667|3180219|Other||Hazard Ratio (HR)|4.99|||||2-Sided|95.0|1.17|21.23||||||The historical control included 10 medulloblastoma patients treated during 1998-2006 who would have been classified as intermediate risk according to SJYC07 criteria (section 13.1.3 of protocol).|
1726322|NCT00602641|3180227|Superiority or Other|||||||0.007|||||||Wilcoxon (Mann-Whitney)||||
1726323|NCT00602641|3180228|Superiority or Other|||||||0.204|||||||Fisher Exact||||
1726324|NCT00602641|3180229|Superiority or Other|||||||0.476|||||||Log Rank|Analysis was based on stratified cox regression by ISS stage (I-II vs. III) and age (< 65y vs. ≥ 65y).|||
1726325|NCT00602641|3180230|Non-Inferiority or Equivalence|Presuming the control over the experimental arm (MPT-T/mPR-R), the inferiority of mPR-R was defined as a PFS treatment hazard ratio (HR) of less than or equal to 0.82 corresponding to median PFS on the mPR-R arm of 20.5 months (mos) vs. 25 mos on the MPT-T arm. With 304 patients and 221 PFS events, there was 86% power to detect non-inferiority of mPR-R at a 1-sided 0.05 significance level assuming a superiority alternative of HR=1.2 corresponding to median PFS on the mPR-R arm of 30 mos.|Hazard Ratio (HR)|0.84|||||2-Sided|90.0|0.67|1.045|||||Analysis based on stratified cox regression by ISS stage (I-II vs. III) and age (< 65y vs. ≥ 65y). The fact that the lower-bound was less than 0.82 and the upper bound was above 1.0 indicates that results were inconclusive for the primary objective.|Since mPR-R was expected to be considerably less toxic and to confer slightly longer PFS, a non-inferiority design with superiority alternative was used.|
1726695|NCT00593957|3181141|Superiority or Other||Mean Difference (Final Values)|5.947|||<|0.05|||||||ANOVA||||
1726326|NCT00602472|3180233|Superiority or Other||Odds Ratio (OR)|3.36|||<|0.0001||95.0|2.474|4.562|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."|
1726327|NCT00602472|3180235|Superiority or Other||Odds Ratio (OR)|3.818|||<|0.0001||95.0|1.989|7.327|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."|
1726328|NCT00602472|3180237|Superiority or Other||Odds Ratio (OR)|5.51|||<|0.0001||95.0|3.332|9.111|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetes medication."|
1726329|NCT00602472|3180238|Superiority or Other||Mean Difference (Final Values)|-12.1|Standard Error of the Mean|2.6|<|0.0001||95.0|-17.2|-7.1|||ANCOVA|||Linagliptin vs. Placebo|
1726330|NCT00602472|3180239|Superiority or Other||Mean Difference (Final Values)|-15.7|Standard Error of the Mean|2.4|<|0.0001||95.0|-20.3|-11.1|||ANCOVA|||Linagliptin vs. Placebo|
1726331|NCT00602472|3180240|Superiority or Other||Mean Difference (Final Values)|-17.8|Standard Error of the Mean|2.3|<|0.0001||95.0|-22.4|-13.2|||ANCOVA|||Linagliptin vs. Placebo|
1726332|NCT00602472|3180241|Superiority or Other||Mean Difference (Final Values)|-12.7|Standard Error of the Mean|2.8|<|0.0001||95.0|-18.1|-7.3|||ANCOVA|||Linagliptin vs. Placebo|
1726333|NCT00602472|3180242|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.05|<|0.0001||95.0|-0.8|-0.59|||ANCOVA|||Linagliptin vs. Placebo|
1726334|NCT00602472|3180243|Superiority or Other||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|0.05|<|0.0001||95.0|-0.78|-0.58|||ANCOVA|||Linagliptin vs. Placebo|
1726335|NCT00602472|3180244|Superiority or Other||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.04|<|0.0001||95.0|-0.56|-0.41|||ANCOVA|||Linagliptin vs. Placebo|
1726336|NCT00602472|3180245|Superiority or Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.06|<|0.0001||95.0|-0.73|-0.5|||ANCOVA|||Linagliptin vs. Placebo|
1726337|NCT00602420|3180254|Superiority or Other|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||Tested at the two-sided 0.05 significance level.|
1726338|NCT00602420|3180254|Superiority or Other||Mean Difference (Final Values)|1.67||||0.037|2-Sided|95.0|0.1|3.24|||t-test, 2 sided|||Tested at the two-sided 0.05 significance level.|
1726339|NCT00601965|3180276|Superiority or Other|||||||0.01|||||||Mixed Models Analysis|Beta = -0.48, 95% CI = -0.84 to -0.11|||
1726340|NCT00601965|3180277|Superiority or Other||||||<|0.001|||||||Log Rank|Log rank test = 32.67, df = 3|||
1726341|NCT00601640|3180313|Superiority or Other|||||||0.022|||||||Fisher Exact||||
1726342|NCT00601458|3180335|Superiority or Other||Median Difference (Final Values)|3.7|||<|0.001||95.0|1.77|6.72||1-sided alpha = 0.045 Hochberg closed testing procedure|Log Rank||Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians||
1726343|NCT00601458|3180335|Superiority or Other||Median Difference (Final Values)|1.46|||<|0.004||95.0|0.183|2.95||1-sided alpha = 0.045 Hochberg closed testing procedure|Log Rank||Hodges-Lehmann procedure was used to obtain an estimate of the difference in medians and an exact CI for the difference in medians||
1726344|NCT00601458|3180336|Superiority or Other||Mean Difference (Final Values)|-65.4||||0.0001||97.8|-81.7|-34.6||1-sided alpha = 0.045 Hochberg closed testing procedure|ANOVA||The natural log scale treatment difference (naproxen – placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.||
1726345|NCT00601458|3180336|Superiority or Other||Mean Difference (Final Values)|-50.7||||0.005||97.8|-73.6|-8.0||1-sided alpha = 0.045 Hochberg closed testing procedure|ANOVA||The natural log scale treatment difference (pregabalin – placebo) and 97.8% CI for the treatment difference were exponentiated and reported as a percentage reduction in 24-h cumulative hydromorphone consumption.||
1726346|NCT00601419|3180337|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was ACTH deficiency. The null hypothesis is that there is no difference between With ACTH deficiency and Without ACTH deficiency in the efficacy of somatropin."|
1726347|NCT00601419|3180338|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between male and female in the efficacy of somatropin."|
1726348|NCT00601419|3180339|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is that there is no difference between <65 years of age and >=65 years of age in the efficacy of somatropin."|
1726349|NCT00601419|3180341|Superiority or Other||||||=|0|||||||Cochran-Armitage Exact|||"The risk factor tested was Initial Dose. The null hypothesis is that there is no linear trend in the frequency of treatment related adverse events across increasing levels of initial dose."|
1726350|NCT00601419|3180341|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Initial Dose. The null hypothesis is that there is no association between Initial Dose and the frequency of treatment related adverse events."|
1726351|NCT00601419|3180342|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Past history. The null hypothesis is that there is no difference between With past history and Without past history in the frequency of treatment related adverse events."|
1726352|NCT00601419|3180343|Superiority or Other||||||=|0|||||||Fisher Exact|||"The null hypothesis is that there is no difference between With TSH deficiency and Without TSH deficiency in the frequency of treatment related adverse events."|
1726353|NCT00601419|3180344|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Gender. The null hypothesis is that there is no difference between Male and Female in the frequency of treatment related adverse events."|
1726354|NCT00601419|3180345|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was Age. The null hypothesis is that there is no difference between <65 years and >=65 years in the frequency of treatment related adverse events."|
1726355|NCT00601250|3180352|Superiority or Other||Least Squares Mean Difference|-41.8|Standard Error of the Mean|10.02|<|0.0001|2-Sided|95.0|-61.71|-21.89|||ANCOVA|||Linagliptin vs. Placebo|
1726356|NCT00601250|3180353|Superiority or Other||Least Squares Mean Difference|-67.13|Standard Error of the Mean|13.88|<|0.0001|2-Sided|95.0|-94.69|-39.58|||ANCOVA|||Linagliptin vs. Placebo|
1726357|NCT00601250|3180354|Superiority or Other||Odds Ratio (OR)|3.754|||<|0.0001||95.0|2.486|5.669|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."|
1726358|NCT00601250|3180356|Superiority or Other||Odds Ratio (OR)|5.456||||0.0016||95.0|1.907|15.614|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."|
1726359|NCT00601250|3180358|Superiority or Other||Odds Ratio (OR)|4.395|||<|0.0001||95.0|2.41|8.013|||Regression, Logistic|||"Linagliptin vs. Placebo~The odds-ratio is based on a logistic regression model including baseline HbA1c and previous antidiabetic medication."|
1726360|NCT00601250|3180359|Superiority or Other||Least Squares Mean Difference|-20.83|Standard Error of the Mean|3.05|<|0.0001||95.0|-26.81|-14.84|||ANCOVA|||Linagliptin vs. Placebo|
1726361|NCT00601250|3180360|Superiority or Other||Least Squares Mean Difference|-16.73|Standard Error of the Mean|2.91|<|0.0001||95.0|-22.44|-11.01|||ANCOVA|||Linagliptin vs. Placebo|
1726362|NCT00601250|3180361|Superiority or Other||Least Squares Mean Difference|-16.52|Standard Error of the Mean|2.67|<|0.0001||95.0|-21.76|-11.29|||ANCOVA|||Linagliptin vs. Placebo|
1726363|NCT00601250|3180362|Superiority or Other||Least Squares Mean Difference|-21.13|Standard Error of the Mean|3.14|<|0.0001||95.0|-27.3|-14.96|||ANCOVA|||Linagliptin vs. Placebo|
1726364|NCT00601250|3180363|Superiority or Other||Least Squares Mean Difference|-0.648|Standard Error of the Mean|0.069|<|0.0001||95.0|-0.785|-0.512|||ANCOVA|||Linagliptin vs. Placebo|
1726365|NCT00601250|3180364|Superiority or Other||Least Squares Mean Difference|-0.596|Standard Error of the Mean|0.064|<|0.0001||95.0|-0.721|-0.471|||ANCOVA|||Linagliptin vs. Placebo|
1726366|NCT00601250|3180365|Superiority or Other||Least Squares Mean Difference|-0.431|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|-0.53|-0.333|||ANCOVA|||Linagliptin vs. Placebo|
1726367|NCT00601250|3180366|Superiority or Other||Least Squares Mean Difference|-0.64|Standard Error of the Mean|0.07|<|0.0001|2-Sided|95.0|-0.78|-0.5|||ANCOVA|||Linagliptin vs. Placebo|
1726368|NCT00601172|3180379|Superiority or Other|||||||0.1572|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (24-120 hours) in Cycle 1|
1726369|NCT00601172|3180379|Superiority or Other|||||||0.2908|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (0-24 hours) in Cycle 1|
1726370|NCT00601172|3180379|Superiority or Other|||||||0.1572|||||||Chi-squared|||Placebo vs. Casopitant 90 mg: (0-120 hours) in Cycle 1|
1726371|NCT00601172|3180380|Superiority or Other||Difference in percentage of participants|0.7||||||97.5|-5.2|6.6|||||The parameter estimated was difference in percentage of participants with response.|Vomiting Impact: Placebo vs. Casopitant 90 mg; Cycle 1 (0-120 hours)|
1726372|NCT00601172|3180380|Superiority or Other||Difference in percentage of participants|-2.6|||||2-Sided|97.5|-9.9|4.7|||||The parameter estimated was difference in percentage of participants with response.|Nausea Impact: Placebo vs. Casopitant 90 mg; Cycle 1 (0-120 hours)|
1726373|NCT00601172|3180381|Superiority or Other||Difference in percentage of participants|-7.3||||0.0507|2-Sided|95.0|-15.0|0.0|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)|
1726374|NCT00601172|3180381|Superiority or Other||Difference in percentage of participants|-4.7||||0.08|2-Sided|95.0|-9.9|0.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)|
1726375|NCT00601172|3180381|Superiority or Other||Difference in percentage of participants|-7.3||||0.0507|2-Sided|95.0|-15.0|0.0|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)|
1726376|NCT00601172|3180382|Superiority or Other||Difference in percentage of participants|-0.9||||0.7799|2-Sided|95.0|-7.3|5.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)|
1726377|NCT00601172|3180382|Superiority or Other||Difference in percentage of participants|0.5||||0.7883|2-Sided|95.0|-3.2|4.2|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)|
1726378|NCT00601172|3180382|Superiority or Other||Difference in percentage of participants|-0.9||||0.7799|2-Sided|95.0|-7.3|5.5|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)|
1726379|NCT00601172|3180383|Superiority or Other||Difference in percentage of participants|8.1||||0.028|2-Sided|95.0|0.9|15.4|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)|
1726380|NCT00601172|3180383|Superiority or Other||Difference in percentage of participants|8.1||||0.028|2-Sided|95.0|0.9|15.4|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)|
1726381|NCT00601172|3180383|Superiority or Other||Difference in percentage of participants|3.8||||0.1356|2-Sided|95.0|-1.2|8.9|||Chi-squared||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)|
1726382|NCT00601172|3180384|Superiority or Other||Percentage of participants|2.1||||0.4846|2-Sided|95.0|-3.8|8.0|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (24-120 hours)|
1726383|NCT00601172|3180384|Superiority or Other||Difference in percentage of participants|0.8||||0.6101|2-Sided|95.0|-2.3|3.9|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-24 hours)|
1726384|NCT00601172|3180384|Superiority or Other||Difference in percentage of participants|2.1||||0.4846|2-Sided|95.0|-3.8|8.0|||Chi-squared||Difference in percentage of participants with response.|Placebo vs Casopitant 90 mg (0-120 hours)|
1726385|NCT00601172|3180385|Superiority or Other||Treament Difference (%)|-0.9||||0.6795|2-Sided|95.0|-5.4|3.5|||Chi-squared|||Placebo vs Casopitant 90 mg (24-120 hours)|
1726386|NCT00601172|3180385|Superiority or Other||Treament Difference (%)|-0.9||||0.4507|2-Sided|95.0|-3.1|1.4|||Chi-squared|||Placebo vs Casopitant 90 mg (0-24 hours)|
1726387|NCT00601172|3180385|Superiority or Other||Treament Difference (%)|-0.9||||0.6795|2-Sided|95.0|-5.4|3.5|||Chi-squared|||Placebo vs Casopitant 90 mg (0-120 hours)|
1726696|NCT00593957|3181142|Superiority or Other||Mean Difference (Final Values)|4.0|||<|0.48|||||||ANOVA||||
1726388|NCT00601172|3180386|Superiority or Other||Treatment difference (%)|-1.8||||0.3986|2-Sided|95.0|-5.9|2.3|||Chi-squared|||Placebo vs Casopitant 90 mg (24-120 hours)|
1726389|NCT00601172|3180386|Superiority or Other||Treatment difference (%)|-0.9||||0.3545|2-Sided|95.0|-2.7|1.0|||Chi-squared|||Placebo vs Casopitant 90 mg (0-24 hours)|
1726390|NCT00601172|3180386|Superiority or Other||Treatment difference (%)|-1.8||||0.3986|2-Sided|95.0|-5.9|2.3|||Chi-squared|||Placebo vs Casopitant 90 mg (0-120 hours)|
1726391|NCT00601172|3180387|Superiority or Other|||||||0.1709|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (24-120 hours)|
1726392|NCT00601172|3180387|Superiority or Other|||||||0.0443|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (0-24 hours)|
1726393|NCT00601172|3180387|Superiority or Other|||||||0.056|||||||Wilcoxon-rank sum test|||Placebo vs Casopitant 90 mg (0-120 hours)|
1726394|NCT00601172|3180388|Superiority or Other||Treatment difference (%)|6.0||||0.0317|2-Sided|95.0|0.5|11.5||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test|||Placebo vs Casopitant 90 mg|
1726395|NCT00601172|3180389|Superiority or Other||Difference in percentage of participants|1.0||||0.7273|2-Sided|95.0|-4.6|6.6|||Pooled Z test|p-value based on normal approximation to the binomial using a pooled Z test.|The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg|
1726396|NCT00601172|3180390|Superiority or Other||Difference in percentage of participants|1.0||||0.4771|2-Sided|95.0|-1.8|3.8||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg|
1726397|NCT00601172|3180391|Superiority or Other||difference in percentage of participants|1.0||||0.7273|2-Sided|95.0|-4.6|6.6||p-value based on normal approximation to the binomial using a pooled Z test.|Pooled Z test||The parameter estimated was difference in percentage of participants with response.|Placebo vs Casopitant 90 mg|
1726398|NCT00601107|3180395|Superiority or Other||Odds Ratio (OR)|0.85||||1|2-Sided|95.0|0.15|4.59||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (<=16, >16).|
1726399|NCT00601107|3180395|Superiority or Other||Odds Ratio (OR)|0.76||||0.992||95.0|0.13|4.14||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (<=16, >16).|
1726400|NCT00601107|3180395|Superiority or Other||Odds Ratio (OR)|0.84||||1|2-Sided|95.0|0.17|4.22||The p-value was not adjusted for multiple comparisons or a prior significance threshold.|Regression, Exact Logistic|||Estimate of the log odds, relative to the Placebo, in participants with at least 50 % reduction in PASI score at Week 12 or early termination was analyzed using exact logistic regression model adjusted for site and baseline PASI strata (<=16, >16).|
1726401|NCT00600886|3180442|Superiority or Other||Odds Ratio (OR)|1.654|||||2-Sided|95.0|0.846|3.234||||||De novo - patients with de novo disease who refused pituitary surgery or for whom pituitary surgery was contraindicated.|
1726402|NCT00600886|3180442|Superiority or Other||Odds Ratio (OR)|2.337|||||2-Sided|95.0|1.14|4.79||||||Post surgery - patients with prior surgery but no previous medical treatment for acromegaly|
1726403|NCT00600886|3180442|Superiority or Other||Odds Ratio (OR)|1.942||||0.007|2-Sided|95.0|1.19|3.168|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel adjusting for randomization stratification factor||Overall - All patients|
1726404|NCT00600821|3180452|Superiority or Other||Risk Ratio (RR)|0.676||||0.9422|2-Sided|95.0|0.412|1.107|||Cochran-Mantel-Haenszel|||P-value was calculated using 1-sided Cochran-Mantel-Haenszel test stratified by gender and prior adjuvant therapy. Risk ratio in comparison to the Bevacizumab group was calculated assuming all other factors as constant.|
1726405|NCT00600821|3180453|Superiority or Other||Hazard Ratio (HR)|1.117||||0.699|2-Sided|95.0|0.739|1.689||One-sided log-rank test at alpha = 0.20 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified by gender and prior adjuvant therapy.|
1726406|NCT00600821|3180454|Superiority or Other||Hazard Ratio (HR)|1.093||||0.639|2-Sided|95.0|0.679|1.761||One-sided log-rank test at alpha = 0.20 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified by gender and prior adjuvant therapy.|
1726407|NCT00600743|3180486|Superiority or Other||Mean Difference (Final Values)|33.4286|Standard Error of the Mean|13.134|<|0.014|2-Sided|||||p-value is based on ANOVA with all groups and conditions and is a planned comparison|ANOVA||df = 53. 26 Used proc GLMMIX in SAS 9.4.|Tests the difference between drug and placebo for group = binge instructions|
1726408|NCT00600743|3180487|Superiority or Other||Mean Difference (Final Values)|49.4|Standard Error of the Mean|22.8||0.033|2-Sided|95.0||||t-test after ANOVA with repeated measures on placebo minus drug (within groups) between binge and normal instructions (between groups)|t-test, 2 sided|This was part of an overall ANOVA (SAS proc mixed) with all four groups (3 doses eat normally. 4 ng dose, binge eat) and the error term had 76 df.||Each group was compared separately in an overall ANOVA with all dose groups included. The results are presented for the groups which received 4 mg dose and instructions to eat normally (normal group) or to binge eat (binge group). The test is the interaction between drug and group i.e. drug effect difference (placebo minus drug) in fullness between the group instructed to binge and the group instructed to eat normally.|
1726409|NCT00600743|3180488|Superiority or Other||Mean Difference (Final Values)|128.2|Standard Error of the Mean|41.4||0.007|2-Sided|95.0||||t test following ANOVA for difference between drug and placebo - There were 3 doses, and the value reported is for the highest and only effective dose|t-test, 2 sided|The overall error term was used to compare differences between placebo and drug||Repeated measures ANOVA|
1726457|NCT00600119|3180525|Superiority or Other|||||||0.7088||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726461|NCT00600119|3180526|Superiority or Other|||||||0.0772||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726410|NCT00600704|3180489|Superiority or Other||Mean Difference (Final Values)|0.797|Standard Error of the Mean|0.168|<|0.05|2-Sided|95.0|0.465|1.129|||Regression, Linear||The mean difference between groups B and A is adjusted for age, gender, BMI and preoperative HCT, while BSA, weight, height, postoperative HCT were not included in the final model to avoid collinearity.|Null hypothesis :restrictive fluid protocol does not have any effect concerning the mean number of PRC units transfused.|
1726411|NCT00600704|3180489|Superiority or Other||Mean Difference (Final Values)|0.379|Standard Deviation|0.096|<|0.05|2-Sided|95.0|0.189|0.569|||t-test, 2 sided|||Sample size calculation was based on a two-sided alpha error of .05 and 80% power. After applying the protocol in two equal groups of 10 patients, the analysis showed that the study requires 60 patients per group. However, we decided to enroll up to 100 patients per group to allow for patient attrition or missing data, and also in order to look for differences with regards to transfusion between patient subgroups.|
1726412|NCT00600340|3180496|Superiority|HR is the hazard rate of Arm B divided by hazard rate of Arm A.|Hazard Ratio (HR)|1.45||||0.0429|2-Sided|95.0|1.01|2.1||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Arm B divided by hazard rate of Arm A.|"HR of Arm B vs. Arm A for DR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age)"|
1726413|NCT00600340|3180497|Superiority|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.41||||0.0582|2-Sided|95.0|0.99|2.02||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for DR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age)"|
1726414|NCT00600340|3180498|Superiority|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|0.56||||0.0001|2-Sided|95.0|0.41|0.75||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for TR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age)"|
1726415|NCT00600340|3180499|Superiority|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|0.57||||0.0001|2-Sided|95.0|0.43|0.77||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for TR (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age)"|
1726416|NCT00600340|3180500|Superiority|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.11||||0.2583|2-Sided|95.0|0.92|1.34||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for TTF (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age)"|
1726417|NCT00600340|3180501|Superiority|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.13||||0.1957|2-Sided|95.0|0.94|1.35||Two-sided log-rank test adjusted by stratification factors at randomization|Log Rank||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for TTF (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age)"|
1726418|NCT00600340|3180502|Superiority|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.31||||0.0094|2-Sided|95.0|1.07|1.61|||Log Rank|Two-sided log-rank test adjusted by stratification factors at randomization|HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for PFS (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age)"|
1726419|NCT00600340|3180503|Superiority|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|Hazard Ratio (HR)|1.32||||0.0066|2-Sided|95.0|1.08|1.61|||Log Rank|Two-sided log-rank test adjusted by stratification factors at randomization|HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|"HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for PFS (stratified)~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age)"|
1726420|NCT00600340|3180504|Superiority||Risk Difference (RD)|-12.0|||||2-Sided|95.0|-19.0|-6.0|||||Difference calculated as DCR in Bevacizumab Plus Capecitabine minus DCR in Bevacizumab plus Paclitaxel, unit in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel|
1726458|NCT00600119|3180525|Superiority or Other|||||||0.7045||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726459|NCT00600119|3180525|Superiority or Other|||||||0.1823||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726421|NCT00600340|3180504|Superiority|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.39||||0.0003|2-Sided|95.0|0.24|0.65||"Test adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)|
1726422|NCT00600340|3180504|Superiority||Risk Difference (RD)|-21.0|||||2-Sided|95.0|-30.0|-13.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, unit in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel|
1726423|NCT00600340|3180504|Superiority||Odds Ratio (OR)|0.42|||<|0.0001|2-Sided|95.0|0.29|0.6||"Test adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)|
1726424|NCT00600340|3180505|Superiority||Risk Difference (RD)|-12.0|||||2-Sided|95.0|-18.0|-6.0|||||Difference calculated as DCR in Bevacizumab Plus Capecitabine minus DCR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel|
1726425|NCT00600340|3180505|Superiority||Odds Ratio (OR)|0.43||||0.0006|2-Sided|95.0|0.27|0.7||"Test adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)|
1726426|NCT00600340|3180505|Superiority||Risk Difference (RD)|-20.0|||||2-Sided|95.0|-28.0|-11.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel|
1726427|NCT00600340|3180505|Superiority|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.44|||<|0.0001|2-Sided|95.0|0.31|0.63||"Test adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)|
1726428|NCT00600340|3180506|Superiority||Risk Difference (RD)|-12.0|||||2-Sided|95.0|-19.0|-6.0|||||Difference calculated as the DCR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel|
1726429|NCT00600340|3180506|Superiority|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.39||||0.0003|2-Sided|95.0|0.24|0.65||"Test adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)|
1726430|NCT00600340|3180506|Superiority||Risk Difference (RD)|-18.0|||||2-Sided|95.0|-26.0|-10.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel|
1726431|NCT00600340|3180506|Superiority|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.45|||<|0.0001|2-Sided|95.0|0.31|0.65||"Test adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|OR of objective response and CMH test (stratified)|
1726432|NCT00600340|3180507|Superiority||Risk Difference (RD)|-12.0|||||2-Sided|95.0|-18.0|-6.0|||||Difference calculated as the DCR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in DCR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel|
1726433|NCT00600340|3180507|Superiority|OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.43||||0.0006|2-Sided|95.0|0.27|0.7||"Test adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for disease control of Bevacizumab Plus Capecitabine divided by the odds for disease control of Bevacizumab plus Paclitaxel|OR of disease control and CMH test (stratified)|
1726434|NCT00600340|3180507|Superiority||Risk Difference (RD)|-17.0|||||2-Sided|95.0|-24.0|-9.0|||||Difference calculated as ORR in Bevacizumab Plus Capecitabine minus ORR in Bevacizumab plus Paclitaxel, units in percent.|Difference in ORR in Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel|
1726435|NCT00600340|3180507|Superiority|OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR)|0.47|||<|0.0001|2-Sided|95.0|0.33|0.67||"Test adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age"|Cochran-Mantel-Haenszel||OR is the odds for objective response of Bevacizumab Plus Capecitabine divided by the odds for objective response of Bevacizumab plus Paclitaxel|Odds Ratio (OR) of objective response and Cochran-Mantel-Haenszel (CMH) test (stratified)|
1726460|NCT00600119|3180525|Superiority or Other|||||||0.5008||||||Analysis for change in PAC-SYM Abdominal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726436|NCT00600340|3180513|Non-Inferiority|Null hypothesis: Hazard Ratio (HR) >= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.126||||0.049|1-Sided|97.5||1.37||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, unstratified).|
1726437|NCT00600340|3180513|Non-Inferiority|Null hypothesis: Hazard Ratio (HR) >= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.058||||0.1778|1-Sided|97.5||1.623||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, unstratified).|
1726438|NCT00600340|3180513|Non-Inferiority|"Null hypothesis: Hazard ratio (HR) >= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age)"|Hazard Ratio (HR)|1.035||||0.0085|1-Sided|97.5||1.273||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, stratified).|
1726439|NCT00600340|3180513|Non-Inferiority|"Null hypothesis: Hazard ratio (HR) >= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age)"|Hazard Ratio (HR)|1.027||||0.1534|1-Sided|97.5||1.606||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, stratified).|
1726440|NCT00600340|3180514|Non-Inferiority|Null hypothesis: Hazard Ratio (HR) >= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.134||||0.0612|1-Sided|97.5||1.386||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, unstratified).|
1726441|NCT00600340|3180514|Non-Inferiority|Null hypothesis: Hazard Ratio (HR) >= 1.33 Based on Cox proportional hazards model.|Hazard Ratio (HR)|1.058||||0.2024|1-Sided|97.5||1.674||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, unstratified).|
1726442|NCT00600340|3180514|Non-Inferiority|"Null hypothesis: Hazard Ratio (HR) >= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age)"|Hazard Ratio (HR)|1.018||||0.007|1-Sided|97.5||1.261||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals. Non-inferiority margin was a HR of 1.33.|Regression, Cox||HR is the hazard rate of Bevacizumab Plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab Plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (final, stratified).|
1726443|NCT00600340|3180514|Non-Inferiority|"Null hypothesis: Hazard Ratio (HR) >= 1.33~Based on Cox proportional hazards model adjusted by stratification factors at randomization:~estrogen and/or progesterone status (positive vs. other)~country~menopausal status (premenopausal or male <=50 years of age vs. postmenopausal or male >50 years of age)"|Hazard Ratio (HR)|1.042||||0.1983|1-Sided|97.5||1.689||Based on approach using repeated confidence intervals, with one-sided 97.5% repeated confidence intervals|Regression, Cox||HR is the hazard rate of Bevacizumab plus Capecitabine divided by hazard rate of Bevacizumab plus Paclitaxel.|HR of Bevacizumab plus Capecitabine vs. Bevacizumab plus Paclitaxel for OS (interim, stratified).|
1726444|NCT00600171|3180524|Superiority or Other||Mean Difference (Final Values)|0.162||||0.001|2-Sided|95.0|0.062|0.261|||ANCOVA||||
1726445|NCT00600171|3180524|Superiority or Other||Median Difference (Final Values)|0.121||||0.016|2-Sided|95.0|0.023|0.22|||ANCOVA||||
1726446|NCT00600171|3180524|Superiority or Other||Mean Difference (Final Values)|0.13||||0.011|2-Sided|95.0|0.03|0.23|||ANCOVA||||
1726447|NCT00600171|3180524|Superiority or Other||Mean Difference (Final Values)|0.069||||0.169|2-Sided|95.0|-0.029|0.168|||ANCOVA||||
1726448|NCT00600171|3180524|Superiority or Other||Mean Difference (Final Values)|0.064||||0.208|2-Sided|95.0|-0.036|0.164|||ANCOVA||||
1726449|NCT00600119|3180525|Superiority or Other|||||||0.1745||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726450|NCT00600119|3180525|Superiority or Other|||||||0.0675||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726451|NCT00600119|3180525|Superiority or Other|||||||0.9317||||||Analysis for change in PAC-SYM Total Score from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726452|NCT00600119|3180525|Superiority or Other|||||||0.0591||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726453|NCT00600119|3180525|Superiority or Other|||||||0.0335||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726454|NCT00600119|3180525|Superiority or Other|||||||0.7848||||||Analysis for change in PAC-SYM Stool Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726455|NCT00600119|3180525|Superiority or Other|||||||0.0116||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726456|NCT00600119|3180525|Superiority or Other|||||||0.5828||||||Analysis for change in PAC-SYM Rectal Symptoms domain from baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726462|NCT00600119|3180526|Superiority or Other|||||||0.0253||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726463|NCT00600119|3180526|Superiority or Other|||||||0.6857||||||Analysis for change in PAC-QOL Total Score from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726464|NCT00600119|3180526|Superiority or Other|||||||0.016||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726465|NCT00600119|3180526|Superiority or Other|||||||0.0171||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726466|NCT00600119|3180526|Superiority or Other|||||||0.4822||||||Analysis for change in PAC-QOL Satisfaction domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726467|NCT00600119|3180526|Superiority or Other|||||||0.4597||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726468|NCT00600119|3180526|Superiority or Other|||||||0.2101||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726469|NCT00600119|3180526|Superiority or Other|||||||0.9938||||||Analysis for change in PAC-QOL Psychosocial Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726470|NCT00600119|3180526|Superiority or Other|||||||0.1155||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726471|NCT00600119|3180526|Superiority or Other|||||||0.0836||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726472|NCT00600119|3180526|Superiority or Other|||||||0.6293||||||Analysis for change in PAC-QOL Worries/Concerns domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726473|NCT00600119|3180526|Superiority or Other|||||||0.1691||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726474|NCT00600119|3180526|Superiority or Other|||||||0.0589||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726475|NCT00600119|3180526|Superiority or Other|||||||0.5522||||||Analysis for change in PAC-QOL Physical Discomfort domain from Baseline (Week 1) to end of treatment (Week 4).|Wilcoxon (Mann-Whitney)||||
1726476|NCT00600119|3180527|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1726477|NCT00600119|3180527|Superiority or Other||||||<|0.0022|||||||Wilcoxon (Mann-Whitney)||||
1726478|NCT00600119|3180527|Superiority or Other||||||<|0.5118|||||||Wilcoxon (Mann-Whitney)||||
1726479|NCT00600119|3180528|Superiority or Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)||||
1726480|NCT00600119|3180528|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1726481|NCT00600119|3180528|Superiority or Other|||||||0.7781|||||||Wilcoxon (Mann-Whitney)||||
1726482|NCT00600106|3180529|Superiority or Other|||||||0.21|||||||Wilcoxon rank sum test||||
1726483|NCT00600106|3180530|Superiority or Other|||||||0.99|||||||Wilcoxon rank sum test||||
1726484|NCT00600106|3180531|Superiority or Other|||||||0.4|||||||Wilcoxon rank sum test||||
1726485|NCT00600106|3180532|Superiority or Other|||||||0.77|||||||Wilcoxon rank sum test||||
1726486|NCT00600106|3180533|Superiority or Other|||||||0.49|||||||Wilcoxon rank sum test||||
1726487|NCT00600106|3180534|Superiority or Other|||||||0.17|||||||t-test (nonparametric Wilcoxon test)|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated. All tests were two-sided with p values <0.05."|
1726488|NCT00600106|3180538|Superiority or Other|All tests were two-sided with p values <0.05.||||||0.38|||||||Wilcoxon rank sum test|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."|
1726489|NCT00600106|3180540|Superiority or Other|All tests were two-sided with p values <0.05.||||||0.77|||||||Wilcoxon rank sum test|||"Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher's exact test for discrete data. The strategy of analysis was intention to treat with comparing the study groups in term of treatment to which they were randomly allocated."|
1726490|NCT00600106|3180541|Superiority or Other|||||||0.93|||||||Wilcoxon rank sum test||||
1726491|NCT00600106|3180542|Superiority or Other|All tests were two-sided with p values <0.05.||||||0.36|||||||t-test (nonparametric Wilcoxon test)|||Data were presented in tables as means and SDs for continuous variables and frequencies for categorical variables. Comparisons between the placebo and 1/10 NA/EE groups were don using Wilcoxon rank sum test for continuous measurement and Fisher’s exact test for discrete data. The strategy of analysis was “intention to treat” with comparing the study groups in term of treatment to which they were randomly allocated.|
1726492|NCT00600067|3180547|Superiority or Other||Mean Difference (Final Values)|-6.7|Standard Error of the Mean|1.26|<|0.0001|2-Sided|95.0|-9.18|-4.21|||ANCOVA||||
1726493|NCT00600067|3180548|Superiority or Other||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|0.17||0.0381|2-Sided|95.0|-0.69|-0.02|||ANCOVA||||
1726494|NCT00600028|3180549|Superiority or Other||Mean Difference (Final Values)|4.0||||0.0001|2-Sided|95.0|||||Mixed Models Analysis||The values represents three months on each intervention||
1726495|NCT00600028|3180550|Superiority or Other||Mean Difference (Final Values)|4.0||||0.001|2-Sided|95.0|||||Mixed Models Analysis||The values represents three months on each intervention||
1727512|NCT00578968|3183004|Superiority or Other||||||<|0.001|||||||ANOVA||||
1726501|NCT00599027|3180637|Superiority or Other|||||||0.001||||||Endpoint after 28 days of treatment|ANCOVA|Overall treatment effect tested using F-test(alpha=0.05;two-sided). Diff between least square means of the 2 groups calculated with two-sided 95% C.I|||
1726502|NCT00598806|3180658|Superiority||Hazard Ratio (HR)|0.81||||0.1038|2-Sided|95.0|0.63|1.04|||Log Rank||||
1726503|NCT00598806|3180659|Superiority||Odds Ratio (OR)|0.76||||0.1094|2-Sided|95.0|0.55|1.06|||Cochran-Mantel-Haenszel||||
1726504|NCT00598663|3180673|Superiority||Mean Difference (Final Values)|0.43|||<|0.0001|1-Sided|97.5|||||ANCOVA|ANOVA with adjustment for period effect and subject as random effect. Period was included in the model regardless of statistical significance.|||
1726505|NCT00598585|3180676|Superiority|unpaired test, the threshold for statistical significance was p= 0.05|||||<|0.05|||||||t-test, 2 sided||||
1726506|NCT00598442|3180685|Superiority or Other||Risk Ratio (RR)|0.98|||||2-Sided|95.0|0.93|1.04|||||||
1726507|NCT00598442|3180685|Superiority or Other||Risk Ratio (RR)|0.96|||||2-Sided|95.0|0.9|1.01|||||||
1726508|NCT00598442|3180686|Superiority or Other||Risk Ratio (RR)|2.1|||||2-Sided|95.0|0.94|4.69|||||||
1726509|NCT00598442|3180686|Superiority or Other||Risk Ratio (RR)|2.28|||||2-Sided|95.0|1.04|5.01|||||||
1726510|NCT00598442|3180687|Non-Inferiority or Equivalence|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% CI for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.31|Standard Error of the Mean|0.102|||2-Sided|97.5|0.08|0.54||||||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.|
1726511|NCT00598442|3180687|Non-Inferiority or Equivalence|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% CI for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.14|Standard Error of the Mean|0.101|||2-Sided|97.5|-0.09|0.36||||||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.|
1726512|NCT00598273|3180688|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.95|1.06|||||||
1726513|NCT00598273|3180688|Superiority or Other||Risk Ratio (RR)|0.99|||||2-Sided|95.0|0.94|1.05|||||||
1726514|NCT00598273|3180689|Superiority or Other||Risk Ratio (RR)|1.48|||||2-Sided|95.0|0.62|3.56|||||||
1726515|NCT00598273|3180689|Superiority or Other||Risk Ratio (RR)|1.25|||||2-Sided|95.0|0.51|3.1|||||||
1726516|NCT00598273|3180690|Non-Inferiority or Equivalence|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.26|Standard Error of the Mean|0.098|||2-Sided|97.5|0.04|0.48||||||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.|
1726517|NCT00598273|3180690|Non-Inferiority or Equivalence|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 97.5% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ -1.0 g/dL.|Least Squares Mean Difference|0.03|Standard Error of the Mean|0.099|||2-Sided|97.5|-0.19|0.26||||||The sample size for this study was determined based on a two-group evaluation of non-inferiority in means with a non-inferiority margin (Δ) of -1.0 g/dL (one-sided significance level of 0.0125, or, comparably, a two-sided significance level of 0.025). A sample size of 450 (150 per treatment group) provided power greater than 99% for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a pooled standard deviation of 1.5 g/dL.|
1726518|NCT00598078|3180691|Superiority or Other|||||||0.038|||||||ANOVA||||
1726519|NCT00598078|3180691|Superiority or Other|||||||0.713|||||||ANOVA||||
1726520|NCT00598078|3180691|Superiority or Other|||||||0.013|||||||ANOVA||||
1726521|NCT00597766|3180716|Superiority or Other||group x time interaction|1.7||||0.3|2-Sided|95.0||||Comparison 40mg vs. 20mg: F (1,35)=1.1, p=0.3|linear mixed model|first order antedependent covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.|
1726522|NCT00597766|3180716|Superiority or Other||group x time interaction|0.4||||0.8|2-Sided|95.0||||Comparison 60mg vs. 20mg: F (1,36)=0.06, p=0.8|linear mixed model|first order antedepentent covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.|
1726571|NCT00596427|3180861|Superiority or Other||||||<|0.1|||||||mixed-effects regression models|This model had fixed effects of treatment, visit and treatment by visit interaction and a random subject effect.||Comparison of change from baseline between groups (treatment effect)|
1726697|NCT00593957|3181142|Superiority or Other||Mean Difference (Final Values)|4.5|||<|0.5|||||||ANOVA||||
1726523|NCT00597766|3180717|Superiority or Other||Groupxtime interaction|1.1||||0.3|2-Sided|95.0||||Comparison 40mg vs. 20mg: F (1,35)=1.0, p=0.3|linear mixed model|Unstructured covariance structure||Secondary outcomes were not powered for analysis. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.|
1726524|NCT00597766|3180717|Superiority or Other||Groupxtime interaction|1.3||||0.2|2-Sided|95.0||||Comparison 60mg vs. 20mg: F (1,36)=1.6, p=0.2|linear mixed model|unstructured covariance structure||The study was not powered for secondary analyses. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.|
1726525|NCT00597766|3180718|Superiority or Other||group x time interaction|-0.02||||0.9|2-Sided|95.0||||Comparison 40mg vs. 20mg: F (1,35)=0.0, p=0.9|linear mixed model|1st order antedependence covariance structure||This study was not powered for secondary outcomes.The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.|
1726526|NCT00597766|3180718|Superiority or Other||group x time interaction|-0.3||||0.2|2-Sided|95.0||||Comparison 60mg vs. 20mg: F (1,36)=1.7, p=0.2|Linear mixed model|first order antedpendent covariance structure||This study was not powered for secondary outcomes. The effect of treatment group over time was analyzed using a linear mixed model for repeated measures with random intercept and subject effects. The dependent variable was treatment group and variables for week (continuous) and group interaction term was included in the model. The effect of treatment at discrete time points was analyzed using a linear mixed model with categorical time.|
1726527|NCT00597766|3180719|Superiority or Other||group x time interaction|-0.04||||0.77|2-Sided|95.0||||Comparison 40mg vs. 20mg: F (1,90)=0.1, p=0.77|linear mixed model|first order antedependent covariance structure||"Hypothesis that 40mg group would have greater pain reduction than the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size > 1.0),18 participants per group are needed. *NOTE* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection."|
1726528|NCT00597766|3180719|Superiority or Other||GroupXtime interaction|-0.17||||0.16|2-Sided|95.0||||Comparison 60mg vs. 20mg: F (1,92)=2.06, p=0.16|Linear mixed model|1st order antedependence covariance structure||"Hypothesis that 60mg group would have greater pain relief than the the 20mg group.~The study was powered to detect the difference in pain between the 40mg and placebo at 4-wks. To detect effect size 0.75 with alpha of 0.05, beta of 0.20, 31 the difference between the 60mg and placebo groups (effect size > 1.0),18 participants per group are needed. *NOTE* the design was changed from placebo-control due to ethical concerns arising from ethical concerns of placebo injection."|
1726529|NCT00597753|3180720|Superiority or Other||Risk Ratio (RR)|0.88|||||2-Sided|95.0|0.79|0.97|||||||
1726530|NCT00597753|3180721|Superiority or Other||Risk Ratio (RR)|1.21|||||2-Sided|95.0|0.76|1.92|||||||
1726531|NCT00597753|3180722|Non-Inferiority or Equivalence|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 95% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ –1.0 g/dL.|Least Squares Mean Difference|-0.15|Standard Error of the Mean|0.072|||2-Sided|95.0|-0.3|-0.01||||||The sample size for this study was determined based on a two group evaluation of non-inferiority using the t-distribution (one-sided significance level 0.025) with a non inferiority margin of -1.0 g/dL. A sample size of approximately 750 (peginesatide group of 500 and epoetin alfa group of 250) provided at least 99% power for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a standard deviation of 1.5 g/dL.|
1726532|NCT00597584|3180737|Superiority or Other||Risk Ratio (RR)|0.96|||||2-Sided|95.0|0.87|1.07|||||||
1726533|NCT00597584|3180738|Superiority or Other||Risk Ratio (RR)|0.79|||||2-Sided|95.0|0.5|1.24|||||||
1726534|NCT00597584|3180739|Non-Inferiority or Equivalence|A non-inferiority margin of -1.0 g/dL was used in the primary efficacy assessments. Non-inferiority was established if the lower limit of the two-sided 95% confidence interval for the difference between the means of the primary endpoint (peginesatide minus control ESA) was ≥ –1.0 g/dL.|Least Squares Mean Difference|0.1|Standard Error of the Mean|0.078|||2-Sided|95.0|-0.05|0.26||||||The sample size for this study has been determined based on a two group evaluation of non-inferiority using the t-distribution (one-sided significance level 0.025) with a non inferiority margin of -1.0 g/dL. A sample size of approximately 750 (peginesatide group of 500 and epoetin group of 250) provided at least 99% power for the evaluation of non-inferiority, assuming an expected treatment difference of 0.0 g/dL and a standard deviation of 1.5 g/dL.|
1726535|NCT00597012|3180775|Superiority or Other (legacy)||Mean Difference (Net)|1.1||||0.68|2-Sided|95.0|-4.4|6.6|||ANCOVA||||
1726536|NCT00597012|3180776|Superiority or Other (legacy)||Mean Difference (Final Values)|2.9||||0.16|2-Sided|95.0|-1.2|7.0|||ANCOVA||||
1726537|NCT00597012|3180777|Superiority or Other (legacy)||Mean Difference (Final Values)|2.4||||0.26|2-Sided|95.0|-1.8|6.5|||ANCOVA|||"The primary analysis was implemented with an analysis of covariance with changes in the WOMAC physical-function score from baseline to 6 months as the dependent variable, treatment as the independent variable of interest, and study site as a covariate.~The primary analysis used a modified intention-to-treat approach in which patients who did not withdraw from the study were evaluated in the group to which they were randomly assigned."|
1726538|NCT00596934|3180799|Superiority or Other|||||||0.026|||||||t-test, 2 sided||||
1726539|NCT00596934|3180800|Superiority or Other|||||||0.195||||||p-value = 0.195.|t-test, 2 sided||||
1726540|NCT00596934|3180801|Superiority or Other|||||||0.023|||||||t-test, 2 sided||||
1726541|NCT00596934|3180802|Superiority or Other|||||||0.006|||||||t-test, 2 sided||||
1726545|NCT00596934|3180806|Superiority or Other|||||||0.015|||||||t-test, 2 sided|||Differences in each collected parameter will be evaluated using a paired t-test. If data are skewed such as in triglyceride levels, nonparametric tests will be used. P<0.05 will be considered significant. If a significant difference can be demonstrated between baseline and 1-year results, a large scale, placebo-controlled trial will be designed using the data obtained from this pilot study|
1726546|NCT00596830|3180814|Superiority or Other||Risk difference|-1.472||||0.685|2-Sided|95.0|-8.6|5.6|||Chi-squared||Risk difference confidence interval was calculated based on a normal distribution.||
1726547|NCT00596830|3180815|Superiority or Other||Hazard Ratio (HR)|1.103||||0.27|2-Sided|95.0|0.925|1.315||2-sided p-value is from the unstratified log-rank test|Log Rank||HR was based on the Cox proportional hazards model||
1726548|NCT00596830|3180816|Superiority or Other||Hazard Ratio (HR)|1.179||||0.064|2-Sided|95.0|0.99|1.404||The p-value stated is the 2-sided p-value from the log rank test stratified by gender, prior adjuvant chemotherapy, and histology.|Log Rank||||
1726549|NCT00596817|3180817|Superiority or Other||Mean Difference (Final Values)|-0.67|Standard Error of the Mean|0.73||0.3642|2-Sided|95.0|-2.12|0.78||A nominal p-value is provided.|ANCOVA||||
1726550|NCT00596817|3180818|Superiority or Other||Difference|12.13||||0.002|2-Sided|95.0|4.73|19.52||A nominal p-value is provided.|Fisher Exact||||
1726551|NCT00596817|3180819|Superiority or Other||Difference|6.35||||0.025|2-Sided|95.0|1.13|11.56||A nominal p-value is provided.|Fisher Exact||||
1726552|NCT00596817|3180820|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.1||0.0002|2-Sided|95.0|-0.57|-0.18||A nominal p-value is provided.|ANCOVA||||
1726553|NCT00596817|3180821|Superiority or Other||Mean Difference (Final Values)|-1.12|Standard Error of the Mean|0.6||0.0612|2-Sided|95.0|-2.3|0.05||A nominal p-value is provided.|ANCOVA||||
1726554|NCT00596817|3180822|Superiority or Other||Mean Difference (Final Values)|-1.31|Standard Error of the Mean|0.55||0.0171|2-Sided|95.0|-2.39|-0.24||A nominal p-value is provided.|ANCOVA||||
1726555|NCT00596817|3180823|Superiority or Other||Mean Difference (Final Values)|-2.06|Standard Error of the Mean|0.66||0.002|2-Sided|95.0|-3.36|-0.77||A nominal p-value is provided.|ANCOVA||||
1726556|NCT00596817|3180824|Superiority or Other||Hazard Ratio (HR)|2.09||||0.001|2-Sided|95.0|1.35|3.23||A nominal p-value is provided.|Cox-Model||||
1726557|NCT00596817|3180825|Superiority or Other||Hazard Ratio (HR)|2.01||||0.0035|2-Sided|95.0|1.26|3.21|||Cox-model|Cox-model using an exact method to handle ties|||
1726558|NCT00596752|3180836|Superiority or Other|||||||0.1154||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 and 2 combined is given by p2=0.01085.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H02: πampPGE1≥ πampPlacebo, with πamp=proportion of subjects with major amputations.~This is the statistical analysis of stage 1 and stage 2 combined."|
1726559|NCT00596752|3180836|Superiority or Other|||||||0.0173||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 is given by p1=0.00587.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H02: πampPGE1≥ πampPlacebo, with πamp=proportion of subjects with major amputations.~The planned information rate for stage 1 of the two-stage group sequential test design with an overall one-sided comparison-wise α=0.0125 for this co-primary endpoint is given by 0.83.~This is the statistical analysis of stage 1."|
1726560|NCT00596752|3180837|Superiority or Other|||||||0.3463||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 and 2 combined is given by p2=0.01085.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H01: πhealingPGE1≤ πhealingPlacebo, with πhealing=proportion of subjects with complete ulcer healing.~This is the statistical analysis of stage 1 and stage 2 combined."|
1726561|NCT00596752|3180837|Superiority or Other|||||||0.2587||||||For confirmatory hypothesis testing the p-values of the normal approximation test for comparing two rates was used as input for the weighted inverse normal method. The 1-sided boundary p-value for stage 1 is given by p1=0.00587.|Cochran-Mantel-Haenszel|The 2 primary endpoints were tested at one-sided 0.0125 each so that the overall type I error rate of 0.025 was controlled in a strong sense.||"Primary goal was to test the following null hypothesis:~H01: πhealingPGE1≤ πhealingPlacebo, with πhealing=proportion of subjects with complete ulcer healing. The planned information rate for stage 1 of the two-stage group sequential test design with an overall one-sided comparison-wise α=0.0125 for this co-primary endpoint is given by 0.83.~This is the statistical analysis of stage 1."|
1726562|NCT00596427|3180852|Superiority or Other||||||<|0.1|||||||mixed-effects regression models||||
1726563|NCT00596427|3180853|Superiority or Other||||||<|0.01|||||||mixed-effects regression models|||Treatment effect of change from baseline|
1726564|NCT00596427|3180854|Superiority or Other||||||<|0.0001|||||||mixed-effects regression models|||Treatment effect of change from baseline|
1726565|NCT00596427|3180855|Superiority or Other|||||||0.3|||||||mixed-effects regression models|||Treatment effect of change from baseline|
1726566|NCT00596427|3180856|Superiority or Other|||||||0.6|||||||mixed-effects regression models||||
1726567|NCT00596427|3180857|Superiority or Other|||||||0.05|||||||mixed-effects regression models||||
1726568|NCT00596427|3180858|Superiority or Other||||||<|0.1|||||||mixed-effects regression models|||Change from baseline between groups were compared (treatment effect)|
1726569|NCT00596427|3180859|Superiority or Other||||||<|0.05|||||||mixed-effects regression models||||
1726570|NCT00596427|3180860|Superiority or Other||||||<|0.01|||||||mixed-effects regression models||||
1726572|NCT00596427|3180862|Superiority or Other||||||<|0.001|||||||mixed-effects regression models|||Change from baseline between groups was compared.|
1726573|NCT00596427|3180863|Superiority or Other||||||<|0.01|||||||mixed-effects regression models|||Change from baseline between groups were compared.|
1726574|NCT00596271|3180865|Non-Inferiority or Equivalence|"Non-inferiority of the combined administration is postulated, if the lower bounds of both twosided 95% confidence intervals for the GMT ratios (of combined vaccination over single vaccination) are > 1/2.~This procedure is equivalent to the approach based on a 1-sided test with a significance level of 2.5% for each comparison with the null hypothesis H0 : ratio ≤ 0.5 versus the alternative hypotheses H1 : ratio > 0.5."|||||<|0.0001|||||||ANOVA|||The primary efficacy analysis will compare the IC51+HAVRIX vs. HAVRIX+Placebo group in terms of the GMT for HAV antibody at day 28. An observed cases approach will be applied for the primary analysis.|
1726575|NCT00596271|3180869|Non-Inferiority or Equivalence|"Non-inferiority of the combined administration is postulated, if the lower bounds of both twosided 95% confidence intervals for the GMT ratios (of combined vaccination over single vaccination) are > 1/2.~This procedure is equivalent to the approach based on a 1-sided test with a significance level of 2.5% for each comparison with the null hypothesis H0 : ratio ≤ 0.5 versus the alternative hypotheses H1 : ratio > 0.5."|||||<|0.0001|||||||ANOVA|||The primary efficacy analysis will compare the IC51+HAVRIX vs. IC51+Placebo group in terms of the GMT for anti- JEV neutralizing antibody at day 56. An observed cases approach will be applied for the primary analysis|
1726576|NCT00595959|3180893|Superiority or Other|||||||0.001||||||No adjustments|t-test, 1 sided|||Comparing to an expected value of 20% reduction from initial to post-laser|
1726577|NCT00595881|3180903|Superiority or Other||Difference in specificity|-2.8||||||95.0|-9.7|4.1||||||as previously described for sensitivity|
1726578|NCT00595881|3180903|Superiority or Other||Difference in sensitivity|-1.7|||||2-Sided|95.0|-3.4|0.0|||||The clinical exam alone was compared to the clinical exam + ultrasound.|See sample size calculations already entered. Null hypothesis is that there is no difference in the sensitivity or specificity of clinical exam alone compared with clinical exam+ultrasound.|
1726579|NCT00595868|3180904|Superiority or Other||Odds Ratio (OR)|2.1||||0.1|2-Sided|95.0|0.9|5.2|||Chi-squared||||
1726580|NCT00595868|3180905|Superiority or Other||Odds Ratio (OR)|1.7||||0.06|2-Sided|95.0|1.0|2.9|||Chi-squared||||
1726581|NCT00595790|3180909|Non-Inferiority or Equivalence|Assessment of non-inferiority of IC51 1x12 mcg vs. IC51 2x6 mcg at Day 56 based on the difference (IC51 1x12 mcg - IC51 2x6 mcg) in SCRs in the PP population. Non-inferiority of IC51 1 x 12 mcg compared to IC51 2 x 6 mcg was accepted if the lower limit of the 95% CI of the adjusted for center SCR difference (IC51 1 x 12 mcg - IC51 2 x 6 mcg) was higher than the noninferiority margin at -10%.|||||>|0.99|||||||Mantel Haenszel||||
1726582|NCT00595764|3180910|Superiority or Other (legacy)||Mean Difference (Final Values)|2.38|Standard Error of the Mean|3.63||0.24|2-Sided|95.0|||||Mixed Models Analysis|Mixed Model Analysis to evaluate interaction of group by time.|||
1726583|NCT00595764|3180911|Superiority or Other (legacy)||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.029||0.58|2-Sided|95.0|||||Mixed Models Analysis|Mixed Model Analysis to evaluate interaction of group by time.|||
1726584|NCT00595764|3180912|Superiority or Other (legacy)||Mean Difference (Final Values)|1.4|Standard Error of the Mean|1.32||0.29|2-Sided|95.0|||||t-test, 2 sided||||
1726585|NCT00595764|3180914|Superiority or Other (legacy)||Mean Difference (Final Values)|0.16|Standard Error of the Mean|1.4||0.91|2-Sided|95.0|||||ANOVA|||With an effect size of 0.46, a sample size of 140 will provide a power of >.84 with p<.05 to detect overall differences between the two treatments on the primary outcome measures.|
1726586|NCT00595556|3180922|Superiority or Other|||||||0.3|||||||Mixed Models Analysis||||
1726587|NCT00595556|3180923|Superiority or Other|||||||0.006|||||||Mixed Models Analysis||||
1726588|NCT00595556|3180924|Superiority or Other|||||||0.004|||||||Mixed Models Analysis||||
1726589|NCT00595556|3180925|Superiority or Other|||||||0.94|||||||Mixed Models Analysis||||
1726590|NCT00595556|3180926|Superiority or Other|||||||0.012|||||||Mixed Models Analysis||||
1726591|NCT00595478|3180936|Superiority||mean ratio|0.74||||0.007|2-Sided|95.0|0.59|0.92|||Poisson regression|Chi-square test with 1 degree of freedom|Mean ratio for percentage of days with alcohol use during the 36 week follow-up period, if alcohol was used: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)||
1726592|NCT00595478|3180936|Superiority||Odds Ratio (OR)|0.82||||0.74|2-Sided|95.0|0.26|2.62|||Poisson regression|Chi-square test with 1 degree of freedom|Odds ratio for 0% days using alcohol during the 36 week follow-up period: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)||
1726593|NCT00595478|3180937|Superiority||mean ratio|0.93||||0.61|2-Sided|95.0|0.71|1.22|||Poisson regression|Chi-square test with 1 degree of freedom|Mean ratio for number of ETG-positive samples, if >0 ETG-positive samples: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)||
1726594|NCT00595478|3180937|Superiority||Odds Ratio (OR)|0.8||||0.66|2-Sided|95.0|0.29|2.18|||Poisson regression|Chi-square test with 1 degree of freedom|Odds ratio for 0 ETG-positive samples for MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator)||
1726595|NCT00595335|3180949|Superiority or Other|||||||0.85|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 12 months.|
1726596|NCT00595335|3180950|Superiority or Other|||||||0.18|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 mental score at 12 months.|
1726597|NCT00595335|3180950|Superiority or Other|||||||0.29|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 physical score at 12 months.|
1726598|NCT00595335|3180950|Superiority or Other|||||||0.91|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 mental score at 6 months.|
1726599|NCT00595335|3180950|Superiority or Other|||||||0.36|||||||t-test, 2 sided|||Comparison of the arms for QoL SF-12 physical score at 6 months.|
1726600|NCT00595335|3180951|Superiority or Other|||||||0.64|||||||t-test, 2 sided|||Comparison of change between groups in extraocular motility at 12 months.|
1726601|NCT00595335|3180951|Superiority or Other|||||||0.21|||||||t-test, 2 sided|||Comparison of change between groups in extraocular motility at 6 months.|
1726602|NCT00595335|3180952|Superiority or Other|||||||0.49|||||||t-test, 2 sided|||Comparison of the change in lid fissure in the left eye between the two groups.|
1726603|NCT00595335|3180952|Superiority or Other|||||||0.98|||||||t-test, 2 sided|||Comparison of the change in lid fissure in the right eye between the two groups.|
1726604|NCT00595335|3180953|Superiority or Other|||||||0.86|||||||t-test, 2 sided|||Comparison of the change between the two groups in change in proptosis in left eye at 12 months.|
1726605|NCT00595335|3180953|Superiority or Other|||||||0.97|||||||t-test, 2 sided|||Comparison of the change between the two groups in proptosis in the right eye at 12 months.|
1726606|NCT00595335|3180955|Superiority or Other|||||||0.85|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 12 months.|
1726607|NCT00595335|3180955|Superiority or Other|||||||0.75|||||||Fisher Exact|||Comparison of the change between the two groups' failure rate at 6 months.|
1726608|NCT00595335|3180956|Superiority or Other|||||||0.73|||||||t-test, 2 sided|||Comparison of the change between the two groups' CAS score at 6 months.|
1726609|NCT00594659|3181014|Superiority or Other||Slope|3.11|Standard Error of the Mean|0.69|<|0.05|2-Sided||||||piecewise mixed model with logit link an|Performed across all assessments.|Slope and p-value above are for group 1: baseline to ETX. Group 3 vs. Group 1 baseline to ETX slope, p < 0.05. All other pairwise comparisons p > 0.05.|pairwise comparisons among groups across 4 follow-up timepoints|
1726610|NCT00594659|3181015|Superiority or Other||||||>|0.05|||||||accelerated bootstrapping|||nonparametric pairwise comparison; non-normal distribution|
1726611|NCT00594659|3181015|Superiority or Other||||||<|0.05|||||||accelerated bootstrapping|||pairwise comparison; non-parametric analysis|
1726612|NCT00594659|3181015|Superiority or Other||||||<|0.05|||||||accelerated bootstrapping|||Pairwise comparison; non-parametric tests performed because of non-normal distribution|
1726613|NCT00594568|3181025|Superiority or Other|||||||0.616|||||||Mixed Models Analysis||||
1726614|NCT00594568|3181025|Superiority or Other|||||||0.075|||||||Mixed Models Analysis||||
1726615|NCT00594568|3181025|Superiority or Other|||||||0.202|||||||Mixed Models Analysis||||
1726616|NCT00594568|3181026|Superiority or Other|||||||0.889|||||||Mixed Models Analysis||||
1726617|NCT00594568|3181026|Superiority or Other|||||||0.149|||||||Mixed Models Analysis||||
1726618|NCT00594568|3181026|Superiority or Other|||||||0.186|||||||Mixed Models Analysis||||
1726619|NCT00594568|3181027|Superiority or Other|||||||0.157|||||||ANCOVA||||
1726620|NCT00594568|3181027|Superiority or Other|||||||0.018|||||||ANCOVA||||
1726621|NCT00594568|3181027|Superiority or Other|||||||0.337|||||||ANCOVA||||
1726622|NCT00594568|3181028|Superiority or Other|||||||0.141|||||||Mixed Models Analysis||||
1726623|NCT00594568|3181028|Superiority or Other|||||||0.005|||||||Mixed Models Analysis||||
1726624|NCT00594568|3181028|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1726625|NCT00594568|3181029|Superiority or Other|||||||0.381|||||||Mixed Models Analysis||||
1726626|NCT00594568|3181029|Superiority or Other|||||||0.016|||||||Mixed Models Analysis||||
1726627|NCT00594568|3181029|Superiority or Other|||||||0.127|||||||Mixed Models Analysis||||
1726628|NCT00594568|3181030|Superiority or Other|||||||0.198|||||||Mixed Models Analysis||||
1726629|NCT00594568|3181030|Superiority or Other|||||||0.002|||||||Mixed Models Analysis||||
1726630|NCT00594568|3181030|Superiority or Other|||||||0.069|||||||Mixed Models Analysis||||
1726631|NCT00594568|3181031|Superiority or Other|||||||0.072|||||||Mixed Models Analysis||||
1726632|NCT00594568|3181031|Superiority or Other|||||||0.013|||||||Mixed Models Analysis||||
1726633|NCT00594568|3181031|Superiority or Other|||||||0.518|||||||Mixed Models Analysis||||
1726634|NCT00594568|3181032|Superiority or Other|||||||0.571|||||||Mixed Models Analysis||||
1726635|NCT00594568|3181032|Superiority or Other|||||||0.018|||||||Mixed Models Analysis||||
1726636|NCT00594568|3181032|Superiority or Other|||||||0.071|||||||Mixed Models Analysis||||
1726637|NCT00594568|3181033|Superiority or Other|||||||0.669|||||||Mixed Models Analysis||||
1726638|NCT00594568|3181033|Superiority or Other|||||||0.022|||||||Mixed Models Analysis||||
1726639|NCT00594568|3181033|Superiority or Other|||||||0.062|||||||Mixed Models Analysis||||
1726640|NCT00594568|3181036|Superiority or Other|||||||0.659|||||||ANCOVA||||
1726641|NCT00594568|3181036|Superiority or Other|||||||0.901|||||||ANCOVA||||
1726642|NCT00594568|3181036|Superiority or Other|||||||0.634|||||||ANCOVA||||
1726643|NCT00594568|3181037|Superiority or Other|||||||0.718|||||||ANCOVA||||
1726644|NCT00594568|3181037|Superiority or Other|||||||0.931|||||||ANCOVA||||
1726645|NCT00594568|3181037|Superiority or Other|||||||0.784|||||||ANCOVA||||
1726646|NCT00594568|3181038|Superiority or Other|||||||0.243||||||This is the p-value for the Right Hippocampal Volume|ANCOVA||||
1726647|NCT00594568|3181038|Superiority or Other|||||||0.82||||||This is the p-value for the Right Hippocampal Volume|ANCOVA||||
1726648|NCT00594568|3181038|Superiority or Other|||||||0.347||||||This is the p-value for the Right Hippocampal Volume|ANCOVA||||
1726649|NCT00594568|3181038|Superiority or Other|||||||0.025||||||This is the p-value for the Left Hippocampal Volume|ANCOVA||||
1726650|NCT00594568|3181038|Superiority or Other|||||||0.464||||||This is the p-value for the Left Hippocampal Volume|ANCOVA||||
1726651|NCT00594568|3181038|Superiority or Other|||||||0.143||||||This is the p-value for the Left Hippocampal Volume|ANCOVA||||
1726652|NCT00594568|3181039|Superiority or Other|||||||0.604|||||||ANCOVA||||
1726653|NCT00594568|3181039|Superiority or Other|||||||0.147|||||||ANCOVA||||
1726654|NCT00594568|3181039|Superiority or Other|||||||0.038|||||||ANCOVA||||
1726655|NCT00594568|3181040|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1726656|NCT00594568|3181040|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1726657|NCT00594568|3181040|Superiority or Other||||||<|0.002|||||||ANCOVA||||
1726658|NCT00594568|3181041|Superiority or Other|||||||0.07|||||||Mixed Models Analysis||||
1726659|NCT00594568|3181041|Superiority or Other|||||||0.068|||||||Mixed Models Analysis||||
1726660|NCT00594568|3181041|Superiority or Other|||||||0.935|||||||Mixed Models Analysis||||
1726661|NCT00594568|3181042|Superiority or Other|||||||0.014|||||||Mixed Models Analysis||||
1726670|NCT00594516|3181049|Non-Inferiority or Equivalence|Non-inferiority margin of (-2, 2). A prespecified equivalence margin of (-2,2) was used for equivalence analysis.|Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.09||||95.0|-0.09|0.28||||||Comparison of Tapentadol IR to ER analysis of variance model with factors for treatment, double blind cross-over period and subject.|
1726671|NCT00594425|3181055|Superiority or Other||Least squares mean|-1.18||||0.7233|2-Sided|95.0|-7.81|5.45||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)|
1726672|NCT00594425|3181055|Superiority or Other||Least squares mean|-0.33||||0.9151|2-Sided|95.0|-6.53|5.86||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)|
1726673|NCT00594425|3181056|Superiority or Other||Percent success|5.48||||0.888|2-Sided|95.0|-10.15|21.11||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)|
1726674|NCT00594425|3181056|Superiority or Other||%success rate|3.09||||0.7889|2-Sided|95.0|-11.16|17.33||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)|
1726675|NCT00594425|3181084|Superiority or Other||Least squares mean|-1.19||||0.6657|2-Sided|95.0|-6.64|4.26||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)|
1726676|NCT00594425|3181084|Superiority or Other||Least squares mean|-2.64||||0.3236|2-Sided|95.0|-7.91|2.63||Priori threshold for statistical significance was 5%|ANCOVA|ANCOVA model including center and baseline lesion count as a covariates. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)|
1726677|NCT00594425|3181085|Superiority or Other||% success rate|3.95||||0.7539|2-Sided|95.0|-8.79|16.69||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)|
1726678|NCT00594425|3181085|Superiority or Other||% success rate|5.53||||0.5288|2-Sided|95.0|-7.97|19.04||Priori threshold for statistical significance was 5%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by center. No adjustment for multiple comparisons was done||H0: τ (Vehicle PDT) = τ (MAL PDT) versus HA: τ (Vehicle PDT) ≠ τ (MAL PDT)|
1726679|NCT00594399|3181089|Superiority or Other||||||<|0.001||||||Omnibus test of difference between groups over time with adjustment for baseline value of physical activity|Mixed Models Analysis||||
1726680|NCT00594399|3181092|Superiority or Other|||||||0.91||||||Omnibus test of difference between groups over time with Bonferroni correction and adjustment for baseline value of glucose|Mixed Models Analysis||||
1726681|NCT00594399|3181095|Superiority or Other|||||||0.43||||||Omnibus test of difference between groups over time with Bonferroni correction and adjustment for baseline value of insulin|Mixed Models Analysis||||
1726682|NCT00594256|3181106|Superiority or Other||||||<|0.01|||||||t-test, 1 sided|||Open label baseline final paired t test|
1726683|NCT00594256|3181107|Superiority or Other|||||||0.8|||||||t-test, 2 sided|||Open label baseline final paired t test|
1726684|NCT00594256|3181108|Superiority or Other|||||||0.04|||||||t-test, 2 sided|||Open label baseline final paired t test|
1726685|NCT00594256|3181109|Superiority or Other|||||||0.02|||||||t-test, 2 sided|||Open label baseline final paired t test|
1726686|NCT00594256|3181110|Superiority or Other||||||=|0|||||||t-test, 2 sided|||Open label baseline final paired t test|
1726687|NCT00594204|3181118|Superiority or Other||Odds Ratio (OR)|5.76|||<|0.0001||95.0|3.74|8.88|||Regression, Logistic|p-value are obtained from a logistic regression model including the main effects of treatment and country|Odds Ratios obtained from a logistic regression model including the main effects of treatment and country||
1726688|NCT00594204|3181119|Superiority or Other||Odds Ratio (OR)|4.3|||<|0.0001||95.0|2.8|6.5||p-values obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds ratios obtained from a logistic regression model including the main effects of treatment and country|Week 24|
1726689|NCT00594204|3181119|Superiority or Other||Odds Ratio (OR)|5.0|||<|0.0001||95.0|3.3|7.5||p-values obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds ratios obtained from a logistic regression model including the main effects of treatment and country|Week 12|
1726690|NCT00594204|3181120|Superiority or Other||Odds Ratio (OR)|4.78|||<|0.0001||95.0|2.97|7.68||p-values are obtained from a logistic regression model including the main effects of treatment and country|Regression, Logistic||Odds Ratios obtained from a logistic regression model including the main effects of treatment and country||
1726691|NCT00594178|3181121|Superiority or Other||Mean Difference (Final Values)|0.0645||||0.011|2-Sided|95.0|0.01827|0.11073|||t-test, 2 sided|||Paired samples T-test was used to assess the statisical changes between baseline and post-exercise bone density.|
1726692|NCT00594178|3181122|Superiority or Other||Mean Difference (Final Values)|-250.8||||0.318|2-Sided|95.0|-778.87|277.21|||t-test, 2 sided|||Paired samples T-test was used to assess the statisical changes between baseline and post-exercise lean muscle mass.|
1726693|NCT00594100|3181131|Superiority or Other||Binomial Proportion|0.054|Standard Error of the Mean|0.016||0.002|2-Sided|95.0|0.027|0.095|||One-Sample Binomial|Significance test was based on a one-sample binomial test|95% Confidence Interval is exact binomial using Clopper-Pearson method. Standard Error is from Normal approximation.|The EMPiRE Study tested the null hypothesis that the true MAE rate was greater than or equal to an Objective Performance Criterion (OPC) of 11.83% versus the alternative hypothesis that the true MAE rate was less than the OPC. The sample size was calculated based on 80% power and a Type I error rate of 0.025. The OPC was calculated from results of published carotid artery stenting studies that utilized distal embolic protection systems.|
1726698|NCT00593957|3181142|Superiority or Other||Mean Difference (Final Values)|8.38|||<|0.1|||||||ANOVA|||Null hypothesis is that there would be no significant difference in social abilities as measured by the SSI score in this treatment group baseline to 6 months post-treatment.|
1726699|NCT00593957|3181144|Superiority or Other||||||<|0.38|||||||t-test, 2 sided||||
1726700|NCT00593957|3181144|Superiority or Other||||||<|0.62|||||||t-test, 2 sided||||
1726701|NCT00593957|3181144|Superiority or Other||||||<|0.4|||||||t-test, 2 sided||||
1726702|NCT00593918|3181145|Superiority or Other|||||||0.14||||||Analysis was per protocol based on the number of children enrolled by genotype and completed nasal washes at first visit.|Mixed Models Analysis|A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.|||
1726703|NCT00593918|3181146|Superiority or Other|||||||0.04|||||||Mixed Models Analysis|A mixed random effects model was used both unadjusted and adjustment for relevant co-variates obtained from the literature.|||
1726704|NCT00593827|3181163|Superiority or Other|||||||0.11|||||||Log Rank||||
1726705|NCT00593827|3181166|Superiority or Other|||||||0.05|||||||Log Rank||||
1726706|NCT00593827|3181167|Superiority or Other|||||||0.03|||||||Log Rank||||
1726707|NCT00593814|3181169|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1726708|NCT00593736|3181170|Superiority or Other|||||||0.041||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726709|NCT00593736|3181170|Superiority or Other|||||||0.156||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726710|NCT00593736|3181170|Superiority or Other|||||||0.589||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726711|NCT00593736|3181171|Superiority or Other|||||||0.055||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726712|NCT00593736|3181171|Superiority or Other|||||||0.214||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726713|NCT00593736|3181171|Superiority or Other|||||||0.685||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726714|NCT00593736|3181172|Superiority or Other|||||||0.29||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726715|NCT00593736|3181172|Superiority or Other|||||||0.59||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726716|NCT00593736|3181172|Superiority or Other|||||||0.902||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726717|NCT00593736|3181173|Superiority or Other|||||||0.727||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726718|NCT00593736|3181173|Superiority or Other|||||||0.765||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726719|NCT00593736|3181173|Superiority or Other|||||||0.307||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726720|NCT00593736|3181174|Superiority or Other|||||||0.242||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726721|NCT00593736|3181174|Superiority or Other|||||||0.751||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726722|NCT00593736|3181174|Superiority or Other|||||||0.513||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726723|NCT00593736|3181175|Superiority or Other|||||||0.978||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726918|NCT00591773|3181558|Superiority or Other||Mean Difference (Final Values)|-12.93|||<|0.001|2-Sided|95.0|-15.92|-9.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726724|NCT00593736|3181175|Superiority or Other|||||||0.321||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726725|NCT00593736|3181175|Superiority or Other|||||||0.837||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726726|NCT00593736|3181176|Superiority or Other|||||||0.834||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726727|NCT00593736|3181176|Superiority or Other|||||||0.997||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726728|NCT00593736|3181176|Superiority or Other|||||||0.86||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726729|NCT00593736|3181177|Superiority or Other|||||||0.549||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726730|NCT00593736|3181177|Superiority or Other|||||||0.082||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726731|NCT00593736|3181177|Superiority or Other|||||||0.441||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726732|NCT00593736|3181178|Superiority or Other|||||||0.982||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726733|NCT00593736|3181178|Superiority or Other|||||||0.093||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726734|NCT00593736|3181178|Superiority or Other|||||||0.413||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726735|NCT00593736|3181179|Superiority or Other|||||||0.774||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726736|NCT00593736|3181179|Superiority or Other|||||||0.463||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726737|NCT00593736|3181179|Superiority or Other|||||||0.157||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726738|NCT00593736|3181180|Superiority or Other|||||||0.611||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726739|NCT00593736|3181180|Superiority or Other|||||||0.399||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726740|NCT00593736|3181180|Superiority or Other|||||||0.684||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726741|NCT00593736|3181181|Superiority or Other|||||||0.362||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726742|NCT00593736|3181181|Superiority or Other|||||||0.331||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726743|NCT00593736|3181181|Superiority or Other|||||||0.655||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726744|NCT00593736|3181182|Superiority or Other|||||||0.999||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1727054|NCT00590590|3181740|Superiority or Other||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 1 < Placebo|
1726745|NCT00593736|3181182|Superiority or Other|||||||0.474||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726746|NCT00593736|3181182|Superiority or Other|||||||0.294||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726747|NCT00593736|3181183|Superiority or Other|||||||0.72||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726748|NCT00593736|3181183|Superiority or Other|||||||0.406||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726749|NCT00593736|3181183|Superiority or Other|||||||0.425||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726750|NCT00593736|3181184|Superiority or Other|||||||0.935||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726751|NCT00593736|3181184|Superiority or Other|||||||0.179||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726752|NCT00593736|3181184|Superiority or Other|||||||0.519||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726753|NCT00593736|3181185|Superiority or Other|||||||0.428||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726754|NCT00593736|3181185|Superiority or Other|||||||0.664||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726755|NCT00593736|3181185|Superiority or Other|||||||0.498||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726756|NCT00593736|3181186|Superiority or Other|||||||0.717||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726757|NCT00593736|3181186|Superiority or Other|||||||0.262||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726758|NCT00593736|3181186|Superiority or Other|||||||0.722||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726759|NCT00593736|3181187|Superiority or Other|||||||0.952||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726760|NCT00593736|3181187|Superiority or Other|||||||0.912||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726761|NCT00593736|3181187|Superiority or Other|||||||0.766||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726762|NCT00593736|3181188|Superiority or Other|||||||0.479||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726763|NCT00593736|3181188|Superiority or Other|||||||0.546||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726764|NCT00593736|3181188|Superiority or Other|||||||0.796||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726765|NCT00593736|3181189|Superiority or Other|||||||0.074||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1727055|NCT00590590|3181740|Superiority or Other||Mean Difference (Final Values)|-0.2||||||||||||||Ha: Drug 1 < Drug 2|
1726766|NCT00593736|3181189|Superiority or Other|||||||0.559||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726767|NCT00593736|3181189|Superiority or Other|||||||0.206||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726768|NCT00593736|3181190|Superiority or Other|||||||0.62||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726769|NCT00593736|3181190|Superiority or Other|||||||0.244||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726770|NCT00593736|3181190|Superiority or Other|||||||0.867||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726771|NCT00593736|3181191|Superiority or Other|||||||0.558||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726772|NCT00593736|3181191|Superiority or Other|||||||0.344||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726773|NCT00593736|3181191|Superiority or Other|||||||0.284||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726774|NCT00593736|3181192|Superiority or Other|||||||0.808||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726775|NCT00593736|3181192|Superiority or Other|||||||0.057||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726776|NCT00593736|3181192|Superiority or Other|||||||0.379||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726777|NCT00593736|3181193|Superiority or Other|||||||0.152||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726778|NCT00593736|3181193|Superiority or Other|||||||0.618||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726779|NCT00593736|3181193|Superiority or Other|||||||0.192||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726780|NCT00593736|3181194|Superiority or Other|||||||0.782||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726781|NCT00593736|3181194|Superiority or Other|||||||0.635||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726782|NCT00593736|3181194|Superiority or Other|||||||0.475||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726783|NCT00593736|3181195|Superiority or Other|||||||0.044||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726784|NCT00593736|3181195|Superiority or Other|||||||0.177||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726785|NCT00593736|3181195|Superiority or Other|||||||0.655||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726786|NCT00593736|3181196|Superiority or Other|||||||0.795||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1727056|NCT00590590|3181741|Superiority or Other||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 2 < Placebo|
1726787|NCT00593736|3181196|Superiority or Other|||||||0.595||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726788|NCT00593736|3181196|Superiority or Other|||||||0.561||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726789|NCT00593736|3181197|Superiority or Other|||||||0.688||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726790|NCT00593736|3181197|Superiority or Other|||||||0.257||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726791|NCT00593736|3181197|Superiority or Other|||||||0.581||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726792|NCT00593736|3181198|Superiority or Other|||||||0.444||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726793|NCT00593736|3181198|Superiority or Other|||||||0.203||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726794|NCT00593736|3181198|Superiority or Other|||||||0.349||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726795|NCT00593736|3181199|Superiority or Other|||||||0.43||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726796|NCT00593736|3181199|Superiority or Other|||||||0.276||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726797|NCT00593736|3181199|Superiority or Other|||||||0.298||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726798|NCT00593736|3181200|Superiority or Other|||||||0.732||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726799|NCT00593736|3181200|Superiority or Other|||||||0.025||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726800|NCT00593736|3181200|Superiority or Other|||||||0.092||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726801|NCT00593736|3181201|Superiority or Other|||||||0.296||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726802|NCT00593736|3181201|Superiority or Other|||||||0.004||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726803|NCT00593736|3181201|Superiority or Other|||||||0.823||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726804|NCT00593736|3181202|Superiority or Other|||||||0.109||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726805|NCT00593736|3181202|Superiority or Other|||||||0.639||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726806|NCT00593736|3181202|Superiority or Other|||||||0.975||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726807|NCT00593736|3181203|Superiority or Other|||||||0.004||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1727057|NCT00590590|3181741|Superiority or Other||Mean Difference (Final Values)|0.1||||||||||||||Ha: Drug 1 < Placebo|
1726808|NCT00593736|3181203|Superiority or Other|||||||0.194||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726809|NCT00593736|3181203|Superiority or Other|||||||0.979||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726810|NCT00593736|3181204|Superiority or Other|||||||0.641||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726811|NCT00593736|3181204|Superiority or Other|||||||0.385||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726812|NCT00593736|3181204|Superiority or Other|||||||0.698||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726813|NCT00593736|3181205|Superiority or Other|||||||0.799||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726814|NCT00593736|3181205|Superiority or Other|||||||0.964||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726815|NCT00593736|3181205|Superiority or Other|||||||0.356||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726816|NCT00593736|3181206|Superiority or Other|||||||0.847||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726817|NCT00593736|3181206|Superiority or Other|||||||0.543||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726818|NCT00593736|3181206|Superiority or Other|||||||0.566||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726819|NCT00593736|3181207|Superiority or Other|||||||0.783||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726820|NCT00593736|3181207|Superiority or Other|||||||0.837||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726821|NCT00593736|3181207|Superiority or Other|||||||0.053||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726822|NCT00593736|3181208|Superiority or Other|||||||0.297||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726823|NCT00593736|3181208|Superiority or Other|||||||0.86||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726824|NCT00593736|3181208|Superiority or Other|||||||0.352||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726825|NCT00593736|3181209|Superiority or Other|||||||0.368||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726826|NCT00593736|3181209|Superiority or Other|||||||0.61||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726827|NCT00593736|3181209|Superiority or Other|||||||0.04||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726828|NCT00593736|3181210|Superiority or Other|||||||0.483||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1727058|NCT00590590|3181741|Superiority or Other||Mean Difference (Final Values)|0.0||||||||||||||Ha: Drug 1 < Drug 2|
1726829|NCT00593736|3181210|Superiority or Other|||||||0.318||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726830|NCT00593736|3181210|Superiority or Other|||||||0.286||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726831|NCT00593736|3181211|Superiority or Other|||||||0.875||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726832|NCT00593736|3181211|Superiority or Other|||||||0.032||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726833|NCT00593736|3181211|Superiority or Other|||||||0.643||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726834|NCT00593736|3181212|Superiority or Other|||||||0.205||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726835|NCT00593736|3181212|Superiority or Other|||||||0.566||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726836|NCT00593736|3181212|Superiority or Other|||||||0.675||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726837|NCT00593736|3181213|Superiority or Other|||||||0.521||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726838|NCT00593736|3181213|Superiority or Other|||||||0.156||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726839|NCT00593736|3181213|Superiority or Other|||||||0.063||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726840|NCT00593736|3181214|Superiority or Other|||||||0.13||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726841|NCT00593736|3181214|Superiority or Other|||||||0.134||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726842|NCT00593736|3181214|Superiority or Other|||||||0.194||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726843|NCT00593736|3181215|Superiority or Other|||||||0.8||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726844|NCT00593736|3181215|Superiority or Other|||||||0.495||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726845|NCT00593736|3181215|Superiority or Other|||||||0.206||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726846|NCT00593736|3181216|Superiority or Other|||||||0.853||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726847|NCT00593736|3181216|Superiority or Other|||||||0.337||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726848|NCT00593736|3181216|Superiority or Other|||||||0.659||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726849|NCT00593736|3181217|Superiority or Other|||||||0.811||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1727150|NCT00588692|3181962|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1726850|NCT00593736|3181217|Superiority or Other|||||||0.117||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726851|NCT00593736|3181217|Superiority or Other|||||||0.972||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726852|NCT00593736|3181218|Superiority or Other|||||||0.737||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726853|NCT00593736|3181218|Superiority or Other|||||||0.871||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726854|NCT00593736|3181218|Superiority or Other|||||||0.197||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726855|NCT00593736|3181219|Superiority or Other|||||||0.324||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726856|NCT00593736|3181219|Superiority or Other|||||||0.323||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726857|NCT00593736|3181219|Superiority or Other|||||||0.691||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726858|NCT00593736|3181220|Superiority or Other|||||||0.188||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726859|NCT00593736|3181220|Superiority or Other|||||||0.082||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726860|NCT00593736|3181220|Superiority or Other|||||||0.511||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726861|NCT00593736|3181221|Superiority or Other|||||||0.166||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726862|NCT00593736|3181221|Superiority or Other|||||||0.926||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726863|NCT00593736|3181221|Superiority or Other|||||||0.051||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726864|NCT00593736|3181222|Superiority or Other|||||||0.418||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726865|NCT00593736|3181222|Superiority or Other|||||||0.525||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726866|NCT00593736|3181222|Superiority or Other|||||||0.9||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726867|NCT00593736|3181223|Superiority or Other|||||||0.268||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726868|NCT00593736|3181223|Superiority or Other|||||||0.121||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726869|NCT00593736|3181223|Superiority or Other|||||||0.365||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726870|NCT00593736|3181224|Superiority or Other|||||||0.853||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1727151|NCT00588692|3181962|Superiority or Other||||||<|0.26|||||||ANOVA||||
1726871|NCT00593736|3181224|Superiority or Other|||||||0.341||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726872|NCT00593736|3181224|Superiority or Other|||||||0.661||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726873|NCT00593736|3181225|Superiority or Other|||||||0.816||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726874|NCT00593736|3181225|Superiority or Other|||||||0.117||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726875|NCT00593736|3181225|Superiority or Other|||||||0.973||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726876|NCT00593736|3181226|Superiority or Other|||||||0.439||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726877|NCT00593736|3181226|Superiority or Other|||||||0.382||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726878|NCT00593736|3181226|Superiority or Other|||||||0.92||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726879|NCT00593736|3181227|Superiority or Other|||||||0.269||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726880|NCT00593736|3181227|Superiority or Other|||||||0.121||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726881|NCT00593736|3181227|Superiority or Other|||||||0.365||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726882|NCT00593736|3181228|Superiority or Other|||||||0.883||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726883|NCT00593736|3181228|Superiority or Other|||||||0.383||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726884|NCT00593736|3181228|Superiority or Other|||||||0.854||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS Means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726885|NCT00593736|3181229|Superiority or Other|||||||0.929||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726886|NCT00593736|3181229|Superiority or Other|||||||0.084||||||Statistical significance was determined at the 0.05 level.|ANCOVA|LS means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the ANCOVA model.|
1726887|NCT00593736|3181229|Superiority or Other|||||||0.646||||||Statistical significance was determined at the 0.05 level.|ANCOVA|Least Squares (LS) means were estimated using an ANCOVA model with treatment and pooled center as class effects and baseline value as a covariate.||The comparison between the 2 treatment groups was made using the analysis of covariance (ANCOVA) model.|
1726888|NCT00593450|3181359|Non-Inferiority or Equivalence|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study [ETDRS] visual-acuity chart)|Mean Difference (Net)|-2.6|Standard Error of the Mean|1.7||0.16|2-Sided|99.2|-5.9|0.8||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.|
1726919|NCT00591773|3181559|Superiority or Other||Mean Difference (Final Values)|-11.2|||<|0.001|2-Sided|95.0|-13.04|-9.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726889|NCT00593450|3181359|Non-Inferiority or Equivalence|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study [ETDRS] visual-acuity chart)|Mean Difference (Net)|-1.2|Standard Error of the Mean|1.7||0.16|2-Sided|99.2|-4.5|2.1||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Avastin Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.|
1726890|NCT00593450|3181359|Non-Inferiority or Equivalence|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study [ETDRS] visual-acuity chart)|Mean Difference (Net)|-2.1|Standard Error of the Mean|1.9||0.16|2-Sided|99.2|-5.7|1.6||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Avastin Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.|
1726891|NCT00593450|3181359|Non-Inferiority or Equivalence|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study [ETDRS] visual-acuity chart)|Mean Difference (Net)|-1.7|Standard Error of the Mean|1.5||0.16|2-Sided|99.2|-4.7|1.3||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Lucentis as Needed Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.|
1726892|NCT00593450|3181359|Non-Inferiority or Equivalence|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study [ETDRS] visual-acuity chart)|Mean Difference (Net)|-0.8|Standard Error of the Mean|1.6||0.16|2-Sided|99.2|-4.1|2.4||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin as Needed Group - Mean VA Change in Lucentis as Needed Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.|
1726893|NCT00593450|3181359|Non-Inferiority or Equivalence|The non-inferiority limit for the difference between study groups in the mean change in visual acuity at 1 year was 5 letters (i.e., one line on the Early Treatment Diabetic Retinopathy Study [ETDRS] visual-acuity chart)|Mean Difference (Net)|-0.5|Standard Error of the Mean|1.7||0.16|2-Sided|99.2|-3.9|2.9||This p-value is for the test of overall difference among 4 treatment groups. The p-value for pairwise comparison was not performed, because this is a non-inferiority trial.|ANOVA|We calcularted of two-sided 99.2% confidence intervals. We used Bonferroni approach to accommodate six pairwise treatment comparisons.|Estimate = Mean VA Change in Avastin Monthly Group - Mean VA Change in Lucentis Monthly Group|The study was designed as a non-inferiority trial among four study groups, with the ability to test for superiority if a treatment was found to be non-inferior. Assuming a standard deviation for changes in visual acuity for 15 letters, we determined that a sample of 277 patients per group (which was increased to 300 to allow for a rate of death or dropout of 8%) would provide a power of 90%.|
1726894|NCT00593385|3181392|Other||Meta-Analysis|9.67||||0.005|1-Sided|95.0||16.57||An exact one sided upper 95% confidence interval of the primary endpoint rate was calculated based on primary analysis population.|Exact test of the binomial distribution||To estimate primary endpoint rate, a meta-analysis was performed on data from 3 previous studies. The meta-analytical rate derived was 9.67%|The composite event rate to determine the performance metric of 16.57% was based on a meta-analysis performed on data from 3 previous studies(9.67%). A 6.9% margin was deemed acceptable at the time of study design. Rejection of the null hypothesis requires that the iCAST Covered Stent primary endpoint rate was significantly below 16.57%. Other assumptions for the analysis included a power of 80% and one-sided alpha error of 5%.|
1726895|NCT00592553|3181470|Other||LS Mean Difference|62.65|Standard Error of the Mean|43.21||0.149|2-Sided|95.0|-22.66|147.96|||Mixed Models Analysis|||Analysis was performed using MMRM method including rank transformed 6MWD as the dependent variable; and rank transformed baseline 6MWD, treatment, visit, age (< 9 years vs. >= 9 years) and corticosteroid use (yes vs. no) stratification factors, and interaction between treatment and visit as independent variables.|
1726920|NCT00591773|3181559|Superiority or Other||Mean Difference (Final Values)|-11.02|||<|0.001|2-Sided|95.0|-12.86|-9.18||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727152|NCT00588692|3181963|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1726896|NCT00592553|3181470|Other||Least Square (LS) Mean Difference|-30.52|Standard Error of the Mean|42.68||0.4756|2-Sided|95.0|-114.8|53.75|||Mixed Models Analysis|||Analysis was performed using mixed model for repeated measures (MMRM) method including rank transformed 6MWD as the dependent variable; and rank transformed baseline 6MWD, treatment, visit, age (less than [<] 9 years versus [vs.] greater than or equal to [>=] 9 years) and corticosteroid use (yes vs. no) stratification factors, and interaction between treatment and visit as independent variables.|
1726897|NCT00592384|3181480|Superiority or Other||||||<|0.025||||||Bonferroni corrected for two primary outcomes|Mixed Models Analysis|||Primary analyses included observations at baseline, 1, 3, 6, 8, 10, and 12 weeks. Random effects were included for participants’ intercepts. Fixed effects were time (linear), treatment (VFN vs. PBO), interaction of time with treatment, stratification factors and potential confounders and variables to improve sensitivity. The primary indicator of treatment effect was the interaction of time by treatment.|
1726898|NCT00592384|3181493|Superiority or Other||||||<|0.025||||||Bonferroni corrected for two primary comparisons|Mixed Models Analysis|see above||Primary analyses included observations at baseline, 1, 3, 6, 8, 10, and 12 weeks. Random effects were included for participants’ intercepts. Fixed effects were time (linear), treatment (VFN vs. PBO), interaction of time with treatment, stratification factors and potential confounders and variables to improve sensitivity. The primary indicator of treatment effect was the interaction of time by treatment.|
1726899|NCT00592176|3181499|Superiority or Other|||||||0.83|||||||t-test, 2 sided||||
1726900|NCT00591942|3181529|Non-Inferiority|95% CI were used|KM Survival Curves|0.5637||||0.5637|2-Sided||||||Chi-squared|df=1|||
1726901|NCT00591773|3181550|Superiority or Other||Odds Ratio (OR)|2.96|||<|0.001|2-Sided|95.0|1.83|4.79||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726902|NCT00591773|3181550|Superiority or Other||Odds Ratio (OR)|4.0|||<|0.001|2-Sided|95.0|2.41|6.64||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726903|NCT00591773|3181551|Superiority or Other||Odds Ratio (OR)|2.7||||0.002|2-Sided|95.0|1.46|5.0||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726904|NCT00591773|3181551|Superiority or Other||Odds Ratio (OR)|3.72|||<|0.001|2-Sided|95.0|1.9|7.27||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726905|NCT00591773|3181552|Superiority or Other||Odds Ratio (OR)|3.03|||<|0.001|2-Sided|95.0|1.82|5.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726906|NCT00591773|3181552|Superiority or Other||Odds Ratio (OR)|4.09|||<|0.001|2-Sided|95.0|2.38|7.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726907|NCT00591773|3181553|Superiority or Other||Mean Difference (Final Values)|-9.69|||<|0.001|2-Sided|95.0|-11.92|-7.46||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726908|NCT00591773|3181553|Superiority or Other||Mean Difference (Final Values)|-9.42|||<|0.001|2-Sided|95.0|-11.65|-7.2||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726909|NCT00591773|3181554|Superiority or Other||Mean Difference (Final Values)|-13.48|||<|0.001|2-Sided|95.0|-16.58|-10.37||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726910|NCT00591773|3181554|Superiority or Other||Mean Difference (Final Values)|-14.04|||<|0.001|2-Sided|95.0|-17.13|-10.94||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726911|NCT00591773|3181555|Superiority or Other||Mean Difference (Final Values)|-11.68|||<|0.001|2-Sided|95.0|-13.64|-9.72||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726912|NCT00591773|3181555|Superiority or Other||Mean Difference (Final Values)|-11.54|||<|0.001|2-Sided|95.0|-13.49|-9.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726913|NCT00591773|3181556|Superiority or Other||Mean Difference (Final Values)|-16.95|||<|0.001|2-Sided|95.0|-19.84|-14.05||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726914|NCT00591773|3181556|Superiority or Other||Mean Difference (Final Values)|-17.52|||<|0.001|2-Sided|95.0|-20.39|-14.64||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726915|NCT00591773|3181557|Superiority or Other||Mean Difference (Final Values)|-8.17|||<|0.001|2-Sided|95.0|-10.15|-6.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726916|NCT00591773|3181557|Superiority or Other||Mean Difference (Final Values)|-8.16|||<|0.001|2-Sided|95.0|-10.14|-6.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726917|NCT00591773|3181558|Superiority or Other||Mean Difference (Final Values)|-12.84|||<|0.001|2-Sided|95.0|-15.83|-9.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727724|NCT00576472|3183503|Superiority or Other|||||||0.4086|||||||t-test, 2 sided||||
1726921|NCT00591773|3181560|Superiority or Other||Mean Difference (Final Values)|-16.24|||<|0.001|2-Sided|95.0|-19.01|-13.47||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726922|NCT00591773|3181560|Superiority or Other||Mean Difference (Final Values)|-16.8|||<|0.001|2-Sided|95.0|-19.56|-14.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726923|NCT00591773|3181561|Superiority or Other||Mean Difference (Final Values)|-7.05|||<|0.001|2-Sided|95.0|-9.06|-5.05||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726924|NCT00591773|3181561|Superiority or Other||Mean Difference (Final Values)|-7.25|||<|0.001|2-Sided|95.0|-9.25|-5.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726925|NCT00591773|3181562|Superiority or Other||Mean Difference (Final Values)|-10.49|||<|0.001|2-Sided|95.0|-12.23|-8.76||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726926|NCT00591773|3181562|Superiority or Other||Mean Difference (Final Values)|-10.29|||<|0.001|2-Sided|95.0|-12.02|-8.56||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726927|NCT00591773|3181563|Superiority or Other||Mean Difference (Final Values)|-12.68|||<|0.001|2-Sided|95.0|-16.1|-9.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA||||
1726928|NCT00591773|3181563|Superiority or Other||Mean Difference (Final Values)|-14.4|||<|0.001|2-Sided|95.0|-17.81|-10.99||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA||||
1726929|NCT00591773|3181564|Superiority or Other||Mean Difference (Final Values)|-15.45|||<|0.001|2-Sided|95.0|-18.13|-12.76||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA||||
1726930|NCT00591773|3181564|Superiority or Other||Mean Difference (Final Values)|-15.86|||<|0.001|2-Sided|95.0|-18.54|-13.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA||||
1726931|NCT00591721|3181569|Superiority or Other||Mean Difference (Net)|-2.53|Standard Deviation|6.47|<|0.05|2-Sided|95.0|-15.47|10.41|||t-test, 2 sided|Each baseline subscale score was subtracted from 7 week subscale score; t-tests assessed mean individual differences between groups.||Hypothesis: Individuals who participate in the program will report significantly reduced fatigue impact immediately post-intervention compared to individuals allocated to the wait-list control group.|
1726932|NCT00591578|3181575|Superiority or Other||Odds Ratio (OR)|1.7|||<|0.001|2-Sided|95.0|1.24|2.33||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.|||
1726933|NCT00591578|3181575|Superiority or Other||Odds Ratio (OR)|1.46|||<|0.018|2-Sided|95.0|1.07|1.99||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.|||
1726934|NCT00591578|3181576|Superiority or Other||Odds Ratio (OR)|1.58||||0.015|2-Sided|95.0|1.09|2.28||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.|||
1726935|NCT00591578|3181576|Superiority or Other||Odds Ratio (OR)|1.46||||0.041|2-Sided|95.0|1.02|2.1||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.|||
1726936|NCT00591578|3181577|Superiority or Other||Odds Ratio (OR)|1.63||||0.002|2-Sided|95.0|1.19|2.23||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.|||
1726937|NCT00591578|3181577|Superiority or Other||Odds Ratio (OR)|1.46||||0.016|2-Sided|95.0|1.07|2.0||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic|Includes only those participants with a baseline and at least one post-baseline value.|||
1726938|NCT00591578|3181578|Superiority or Other||Mean Difference (Final Values)|-2.59||||0.004|2-Sided|95.0|-4.34|-0.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726939|NCT00591578|3181578|Superiority or Other||Mean Difference (Final Values)|-2.31||||0.009|2-Sided|95.0|-4.04|-0.59||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726940|NCT00591578|3181579|Superiority or Other||Mean Difference (Final Values)|-3.47||||0.005|2-Sided|95.0|-5.87|-1.06||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726941|NCT00591578|3181579|Superiority or Other||Mean Difference (Final Values)|-3.38||||0.005|2-Sided|95.0|-5.76|-1.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726942|NCT00591578|3181580|Superiority or Other||Mean Difference (Final Values)|-2.73|||<|0.001|2-Sided|95.0|-4.2|-1.25||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726943|NCT00591578|3181580|Superiority or Other||Mean Difference (Final Values)|-2.18|||<|0.003|2-Sided|95.0|-3.63|-0.72||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726944|NCT00591578|3181581|Superiority or Other||Mean Difference (Final Values)|-4.01|||<|0.001|2-Sided|95.0|-6.16|-1.85||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726945|NCT00591578|3181581|Superiority or Other||Mean Difference (Final Values)|-3.44|||<|0.002|2-Sided|95.0|-5.57|-1.3||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726946|NCT00591578|3181582|Superiority or Other||Mean Difference (Final Values)|-2.84|||<|0.001|2-Sided|95.0|-4.33|-1.35||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726947|NCT00591578|3181582|Superiority or Other||Mean Difference (Final Values)|-2.0|||<|0.008|2-Sided|95.0|-3.48|-0.53||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726948|NCT00591578|3181583|Superiority or Other||Mean Difference (Final Values)|-4.44|||<|0.001|2-Sided|95.0|-6.63|-2.24||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726949|NCT00591578|3181583|Superiority or Other||Mean Difference (Final Values)|-3.79|||<|0.001|2-Sided|95.0|-5.96|-1.62||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726950|NCT00591578|3181584|Superiority or Other||Mean Difference (Final Values)|-2.67|||<|0.001|2-Sided|95.0|-4.06|-1.28||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726951|NCT00591578|3181584|Superiority or Other||Mean Difference (Final Values)|-2.17|||<|0.002|2-Sided|95.0|-3.54|-0.79||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726952|NCT00591578|3181585|Superiority or Other||Mean Difference (Final Values)|-3.9|||<|0.001|2-Sided|95.0|-5.96|-1.83||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726953|NCT00591578|3181585|Superiority or Other||Mean Difference (Final Values)|-3.49|||<|0.001|2-Sided|95.0|-5.53|-1.44||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726954|NCT00591578|3181586|Superiority or Other||Mean Difference (Final Values)|-2.76|||<|0.001|2-Sided|95.0|-4.32|-1.21||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726955|NCT00591578|3181586|Superiority or Other||Mean Difference (Final Values)|-2.52|||<|0.001|2-Sided|95.0|-4.06|-0.98||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726956|NCT00591578|3181587|Superiority or Other||Mean Difference (Final Values)|-2.69|||<|0.001|2-Sided|95.0|-3.99|-1.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726957|NCT00591578|3181587|Superiority or Other||Mean Difference (Final Values)|-2.16|||<|0.001|2-Sided|95.0|-3.44|-0.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726958|NCT00591578|3181588|Superiority or Other||Mean Difference (Final Values)|-5.34|||<|0.001|2-Sided|95.0|-8.0|-2.68||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726959|NCT00591578|3181588|Superiority or Other||Mean Difference (Final Values)|-3.27|||<|0.015|2-Sided|95.0|-5.9|-0.63||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). The unadjusted p-value is presented.|ANCOVA||||
1726960|NCT00591578|3181589|Superiority or Other||Mean Difference (Final Values)|-4.03|||<|0.001|2-Sided|95.0|-6.01|-2.06||Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1726961|NCT00591578|3181589|Superiority or Other||Mean Difference (Final Values)|-3.64|||<|0.001|2-Sided|95.0|-5.59|-1.69||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value presented. Overall 0.05 level of significance for multiple comparisons controlled using stepwise testing procedure.|ANCOVA||||
1726962|NCT00591266|3181635|Superiority or Other||Odds Ratio (OR)|3.12|||<|0.001|2-Sided|95.0|2.01|4.82||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726963|NCT00591266|3181635|Superiority or Other||Odds Ratio (OR)|2.62|||<|0.001|2-Sided|95.0|1.71|4.02||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726964|NCT00591266|3181636|Superiority or Other||Odds Ratio (OR)|3.9|||<|0.001|2-Sided|95.0|2.25|6.75||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726965|NCT00591266|3181636|Superiority or Other||Odds Ratio (OR)|3.54|||<|0.001|2-Sided|95.0|2.08|6.02||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726966|NCT00591266|3181637|Superiority or Other||Odds Ratio (OR)|3.21|||<|0.001|2-Sided|95.0|2.05|5.03||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726967|NCT00591266|3181637|Superiority or Other||Odds Ratio (OR)|3.37|||<|0.001|2-Sided|95.0|2.15|5.26||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726968|NCT00591266|3181638|Superiority or Other||Mean Difference (Final Values)|-6.54|||<|0.001|2-Sided|95.0|-8.47|-4.61||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726969|NCT00591266|3181638|Superiority or Other||Mean Difference (Final Values)|-5.94|||<|0.001|2-Sided|95.0|-7.88|-4.0||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726970|NCT00591266|3181639|Superiority or Other||Mean Difference (Final Values)|-8.91|||<|0.001|2-Sided|95.0|-11.51|-6.3||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726971|NCT00591266|3181639|Superiority or Other||Mean Difference (Final Values)|-8.83|||<|0.001|2-Sided|95.0|-11.45|-6.22||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726972|NCT00591266|3181640|Superiority or Other||Mean Difference (Final Values)|-8.23|||<|0.001|2-Sided|95.0|-9.82|-6.64||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726973|NCT00591266|3181640|Superiority or Other||Mean Difference (Final Values)|-8.39|||<|0.001|2-Sided|95.0|-9.98|-6.79||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726974|NCT00591266|3181641|Superiority or Other||Mean Difference (Final Values)|-11.58|||<|0.001|2-Sided|95.0|-13.93|-9.23||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726975|NCT00591266|3181641|Superiority or Other||Mean Difference (Final Values)|-12.27|||<|0.001|2-Sided|95.0|-14.63|-9.92||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726976|NCT00591266|3181642|Superiority or Other||Mean Difference (Final Values)|-6.28|||<|0.001|2-Sided|95.0|-7.96|-4.6||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726977|NCT00591266|3181642|Superiority or Other||Mean Difference (Final Values)|-6.26|||<|0.001|2-Sided|95.0|-7.94|-4.57||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726978|NCT00591266|3181643|Superiority or Other||Mean Difference (Final Values)|-9.67|||<|0.001|2-Sided|95.0|-12.03|-7.31||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726979|NCT00591266|3181643|Superiority or Other||Mean Difference (Final Values)|-9.7|||<|0.001|2-Sided|95.0|-12.07|-7.34||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726980|NCT00591266|3181644|Superiority or Other||Mean Difference (Final Values)|-8.04|||<|0.001|2-Sided|95.0|-9.52|-6.55||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726981|NCT00591266|3181644|Superiority or Other||Mean Difference (Final Values)|-7.99|||<|0.001|2-Sided|95.0|-9.47|-6.5||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726982|NCT00591266|3181645|Superiority or Other||Mean Difference (Final Values)|-11.17|||<|0.001|2-Sided|95.0|-13.39|-8.95||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726983|NCT00591266|3181645|Superiority or Other||Mean Difference (Final Values)|-11.64|||<|0.001|2-Sided|95.0|-13.86|-9.41||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726984|NCT00591266|3181646|Superiority or Other||Mean Difference (Final Values)|-5.58|||<|0.001|2-Sided|95.0|-7.28|-3.88||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726985|NCT00591266|3181646|Superiority or Other||Mean Difference (Final Values)|-4.93|||<|0.001|2-Sided|95.0|-6.62|-3.23||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726986|NCT00591266|3181647|Superiority or Other||Mean Difference (Final Values)|-7.65|||<|0.001|2-Sided|95.0|-9.01|-6.28||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726987|NCT00591266|3181647|Superiority or Other||Mean Difference (Final Values)|-7.48|||<|0.001|2-Sided|95.0|-8.84|-6.11||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726988|NCT00591266|3181648|Superiority or Other||Mean Difference (Final Values)|-9.56|||<|0.001|2-Sided|95.0|-12.48|-6.63||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA||||
1726989|NCT00591266|3181648|Superiority or Other||Mean Difference (Final Values)|-11.02|||<|0.001|2-Sided|95.0|-13.93|-8.1||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA||||
1726990|NCT00591266|3181649|Superiority or Other||Mean Difference (Final Values)|-10.91|||<|0.001|2-Sided|95.0|-13.0|-8.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA||||
1726991|NCT00591266|3181649|Superiority or Other||Mean Difference (Final Values)|-11.19|||<|0.001|2-Sided|95.0|-13.29|-9.09||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA||||
1726992|NCT00591253|3181650|Superiority or Other||Odds Ratio (OR)|2.84|||<|0.001|2-Sided|95.0|1.57|5.13||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726993|NCT00591253|3181650|Superiority or Other||Odds Ratio (OR)|2.35|||<|0.004|2-Sided|95.0|1.31|4.24||P-value for joint response criteria for systolic blood pressure and diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726994|NCT00591253|3181651|Superiority or Other||Odds Ratio (OR)|1.89||||0.015|2-Sided|95.0|1.13|3.16||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726995|NCT00591253|3181651|Superiority or Other||Odds Ratio (OR)|1.85||||0.018|2-Sided|95.0|1.11|3.08||P-value for response criteria for diastolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic diastolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726996|NCT00591253|3181652|Superiority or Other||Odds Ratio (OR)|1.93||||0.016|2-Sided|95.0|1.13|3.31||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726997|NCT00591253|3181652|Superiority or Other||Odds Ratio (OR)|2.15||||0.004|2-Sided|95.0|1.27|3.65||P-value for response criteria for systolic blood pressure was from a logistic regression with treatment as a factor and baseline clinic systolic blood pressure as a covariate. The unadjusted p-value is presented.|Regression, Logistic||||
1726998|NCT00591253|3181653|Superiority or Other||Mean Difference (Final Values)|-7.55|||<|0.001|2-Sided|95.0|-10.63|-4.48||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1726999|NCT00591253|3181653|Superiority or Other||Mean Difference (Final Values)|-4.04|||<|0.012|2-Sided|95.0|-7.17|-0.91||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727000|NCT00591253|3181654|Superiority or Other||Mean Difference (Final Values)|-8.71|||<|0.001|2-Sided|95.0|-12.5|-4.92||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727001|NCT00591253|3181654|Superiority or Other||Mean Difference (Final Values)|-4.86|||<|0.014|2-Sided|95.0|-8.72|-1.01||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727002|NCT00591253|3181655|Superiority or Other||Mean Difference (Final Values)|-5.65|||<|0.001|2-Sided|95.0|-7.88|-3.41||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727003|NCT00591253|3181655|Superiority or Other||Mean Difference (Final Values)|-3.81|||<|0.001|2-Sided|95.0|-6.08|-1.54||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727004|NCT00591253|3181656|Superiority or Other||Mean Difference (Final Values)|-7.71|||<|0.001|2-Sided|95.0|-10.88|-4.55||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727005|NCT00591253|3181656|Superiority or Other||Mean Difference (Final Values)|-5.3|||<|0.001|2-Sided|95.0|-8.52|-2.08||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727006|NCT00591253|3181657|Superiority or Other||Mean Difference (Final Values)|-5.79|||<|0.001|2-Sided|95.0|-8.39|-3.19||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727007|NCT00591253|3181657|Superiority or Other||Mean Difference (Final Values)|-3.05|||<|0.024|2-Sided|95.0|-5.69|-0.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727008|NCT00591253|3181658|Superiority or Other||Mean Difference (Final Values)|-7.27|||<|0.001|2-Sided|95.0|-10.85|-3.69||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727009|NCT00591253|3181658|Superiority or Other||Mean Difference (Final Values)|-4.91|||<|0.008|2-Sided|95.0|-8.54|-1.27||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727010|NCT00591253|3181659|Superiority or Other||Mean Difference (Final Values)|-5.9|||<|0.001|2-Sided|95.0|-7.99|-3.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727053|NCT00590590|3181740|Superiority or Other||Mean Difference (Final Values)|0.3||||||||||||||Ha: Drug 2 < Placebo|
1727725|NCT00576472|3183503|Superiority or Other|||||||0.0003|||||||t-test, 2 sided||||
1727011|NCT00591253|3181659|Superiority or Other||Mean Difference (Final Values)|-3.74|||<|0.001|2-Sided|95.0|-5.86|-1.61||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727012|NCT00591253|3181660|Superiority or Other||Mean Difference (Final Values)|-7.97|||<|0.001|2-Sided|95.0|-10.96|-4.97||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727013|NCT00591253|3181660|Superiority or Other||Mean Difference (Final Values)|-5.09|||<|0.001|2-Sided|95.0|-8.14|-2.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727014|NCT00591253|3181661|Superiority or Other||Mean Difference (Final Values)|-2.96||||0.006|2-Sided|95.0|-5.08|-0.84||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727015|NCT00591253|3181661|Superiority or Other||Mean Difference (Final Values)|-3.12||||0.004|2-Sided|95.0|-5.22|-1.02||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727016|NCT00591253|3181662|Superiority or Other||Mean Difference (Final Values)|-5.77|||<|0.001|2-Sided|95.0|-7.78|-3.77||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727017|NCT00591253|3181662|Superiority or Other||Mean Difference (Final Values)|-3.44|||<|0.001|2-Sided|95.0|-5.47|-1.4||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1727018|NCT00591253|3181663|Superiority or Other||Mean Difference (Final Values)|-6.54|||<|0.001|2-Sided|95.0|-10.27|-2.81||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA||||
1727019|NCT00591253|3181663|Superiority or Other||Mean Difference (Final Values)|-6.48|||<|0.001|2-Sided|95.0|-10.18|-2.78||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA||||
1727020|NCT00591253|3181664|Superiority or Other||Mean Difference (Final Values)|-7.78|||<|0.001|2-Sided|95.0|-10.69|-4.86||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA||||
1727021|NCT00591253|3181664|Superiority or Other||Mean Difference (Final Values)|-5.0|||<|0.001|2-Sided|95.0|-7.97|-2.04||Postbaseline P-value was from ANCOVA with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented. Overall 0.05 level of significance for multiple comparisons controlled using closed testing procedure.|ANCOVA||||
1727022|NCT00591227|3181666|Superiority or Other|||||||0.58|||||||t-test, 1 sided||||
1727023|NCT00591006|3181681|Superiority or Other|||||||0.06|||||||Mixed Models Analysis||||
1727024|NCT00591006|3181681|Superiority or Other|||||||0.11|||||||Mixed Models Analysis||||
1727025|NCT00591006|3181681|Superiority or Other||||||<|0.01|||||||Mixed Models Analysis||||
1727026|NCT00591006|3181681|Superiority or Other||||||<|0.08|||||||Mixed Models Analysis||||
1727027|NCT00591006|3181682|Superiority or Other|||||||0.02|||||||Mixed Models Analysis||||
1727028|NCT00591006|3181682|Superiority or Other||||||<|0.01|||||||Mixed Models Analysis||||
1727029|NCT00591006|3181682|Superiority or Other||||||<|0.01|||||||Mixed Models Analysis||||
1727030|NCT00591006|3181682|Superiority or Other||||||<|0.08|||||||Mixed Models Analysis||||
1727031|NCT00591006|3181683|Superiority or Other|||||||0.1|||||||Mixed Models Analysis||||
1727032|NCT00591006|3181683|Superiority or Other|||||||0.15|||||||Mixed Models Analysis||||
1727033|NCT00591006|3181683|Superiority or Other|||||||0.12|||||||Mixed Models Analysis||||
1727034|NCT00591006|3181683|Superiority or Other||||||<|0.01|||||||Mixed Models Analysis||||
1727035|NCT00590720|3181722|Superiority or Other|||||||0.52|||||||Two-sample t-test||||
1727036|NCT00590720|3181723|Superiority or Other|||||||0.16|||||||Two-sample t-test||||
1727037|NCT00590720|3181724|Superiority or Other|||||||0.22|||||||Two-sample t-test||||
1727038|NCT00590720|3181725|Superiority or Other|||||||0.53|||||||Two-sample t-test||||
1727039|NCT00590720|3181726|Superiority or Other||||||<|0.01|||||||Two-sample t-test||||
1727040|NCT00590720|3181727|Superiority or Other|||||||0.4|||||||Two-sample t-test||||
1727041|NCT00590590|3181736|Superiority or Other||Mean Difference (Final Values)|0.7||||||||||||||Ha: Drug 2 < Placebo|
1727042|NCT00590590|3181736|Superiority or Other||Mean Difference (Final Values)|-0.6||||||||||||||Ha: Drug 1 < Placebo|
1727043|NCT00590590|3181736|Superiority or Other||Mean Difference (Final Values)|-1.3||||||||||||||Ha: Drug 1 < Drug 2|
1727044|NCT00590590|3181737|Superiority or Other||Mean Difference (Final Values)|11.0||||||||||||||Ha: Drug 2 < Placebo|
1727045|NCT00590590|3181737|Superiority or Other||Mean Difference (Final Values)|5.9||||||||||||||Ha: Drug 1 < Placebo|
1727046|NCT00590590|3181737|Superiority or Other||Mean Difference (Final Values)|-5.1||||||||||||||Ha: Drug 1 < Drug 2|
1727047|NCT00590590|3181738|Superiority or Other||Mean Difference (Final Values)|-0.3||||||||||||||Ha: Drug 2 < Placebo|
1727048|NCT00590590|3181738|Superiority or Other||Mean Difference (Final Values)|9.0||||||||||||||Ha: Drug 1 < Placebo|
1727049|NCT00590590|3181738|Superiority or Other||Mean Difference (Final Values)|9.3||||||||||||||Ha: Drug 1 < Drug 2|
1727050|NCT00590590|3181739|Superiority or Other||Mean Difference (Final Values)|10.8||||||||||||||Ha: Drug 2 < Placebo|
1727051|NCT00590590|3181739|Superiority or Other||Mean Difference (Final Values)|4.7||||||||||||||Ha: Drug 1 < Placebo|
1727052|NCT00590590|3181739|Superiority or Other||Mean Difference (Final Values)|-6.1||||||||||||||Ha: Drug 1 < Drug 2|
1727059|NCT00590577|3181742|Superiority or Other|||||||0.14||||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.|
1727060|NCT00590577|3181742|Superiority or Other|||||||0.005||||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.|
1727061|NCT00590577|3181742|Superiority or Other||||||<|0.001||||||Comparisons with placebo were without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment and country as factors, and (non-ranked) baseline CGI-S score as a covariate.|
1727062|NCT00590577|3181743|Superiority or Other||Difference in least-squares means|1.0|Standard Error of the Mean|1.5||0.509||95.0|-1.96|3.95||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.|
1727063|NCT00590577|3181743|Superiority or Other||Difference in least-squares means|4.4|Standard Error of the Mean|1.5||0.007||95.0|1.43|7.31||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.|
1727064|NCT00590577|3181743|Superiority or Other||Difference in least-squares means|6.2|Standard Error of the Mean|1.49|<|0.001||95.0|3.26|9.12||P-values were adjusted for multiplicity between PANSS total score (primary efficacy endpoint) and PSP, as well as different dose levels in comparison with placebo, using the Dunnett-Bonferroni-based parallel gatekeeping method.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|Analysis of the key secondary endpoint was conducted using an analysis of covariance model with treatment and country as factors, and the baseline PSP score as a covariate. The Dunnett-Bonferroni-based parallel gatekeeping approach was used to adjust for multiple testing.|
1727065|NCT00590577|3181744|Superiority or Other||Difference in least-squares means|-5.1|Standard Error of the Mean|2.01||0.034||95.0|-9.01|-1.1||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett’s method in each family of hypotheses and using Bonferroni’s inequality between different families.|
1727066|NCT00590577|3181744|Superiority or Other||Difference in least-squares means|-8.7|Standard Error of the Mean|2.0|<|0.001||95.0|-12.62|-4.78||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett’s method in each family of hypotheses and using Bonferroni’s inequality between different families.|
1727067|NCT00590577|3181744|Superiority or Other||Difference in least-squares means|-9.8|Standard Error of the Mean|2.0|<|0.001||95.0|-13.71|-5.85||Used analysis of covariance model with treatment (placebo, paliperidone palmitate 25, 100, 150 mg eq.) and country as factors and baseline value as a covariate. P-values adjusted for multiplicity for comparison with placebo using Dunnett's test.|ANCOVA||The 95% confidence intervals were unadjusted for multiplicity.|The overall type I error rate for testing all paliperidone palmitate doses vs. placebo for both the primary outcome and key secondary outcome was controlled at the 2-sided 0.05 significance level. The 2 families of hypotheses (in each family, comparison of each paliperidone palmitate dose vs. placebo) were tested using a parallel gatekeeping procedure that adjusts for multiplicity by using Dunnett’s method in each family of hypotheses and using Bonferroni’s inequality between different families.|
1727068|NCT00589979|3181789|Superiority or Other||Mean Difference (Net)|8.31||||0.3769||95.0|-10.3|27.0||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Supplementation: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727107|NCT00589914|3181806|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.06|||2-Sided|95.0|-0.07|0.17||||||The change from baseline was analyzed using an ANCOVA model with factors for treatment and country and baseline score as a covariate.|
1727153|NCT00588692|3181963|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1727154|NCT00588692|3181963|Superiority or Other||||||<|0.5|||||||ANOVA||||
1727069|NCT00589979|3181789|Superiority or Other||Mean Difference (Net)|1.18||||0.9108||95.0|-19.8|22.2||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Effectiveness: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727070|NCT00589979|3181789|Superiority or Other||Mean Difference (Net)|22.16||||0.1143||95.0|-5.48|49.8||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Disturbance: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727071|NCT00589979|3181790|Superiority or Other||Odds Ratio (OR)|0.88||||0.6833||95.0|0.47|1.65||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Logistic|An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects.|The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.||
1727072|NCT00589979|3181791|Superiority or Other||Mean Difference (Net)|1.74||||0.1378||95.0|-0.57|4.04||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates|
1727073|NCT00589979|3181792|Superiority or Other||Odds Ratio (OR)|0.76||||0.3193||95.0|0.44|1.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.|
1727074|NCT00589979|3181793|Superiority or Other||Odds Ratio (OR)|0.71||||0.2605||95.0|0.38|1.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.|
1727075|NCT00589979|3181794|Superiority or Other||Mean Difference (Net)|0.01||||0.3773||95.0|-0.02|0.04||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727076|NCT00589979|3181796|Superiority or Other||Mean Difference (Net)|0.12||||0.7839||95.0|-0.74|0.98||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727077|NCT00589979|3181797|Superiority or Other||Odds Ratio (OR)|1.22||||0.4748||95.0|0.72|2.06||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.|Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.|
1727078|NCT00589979|3181798|Superiority or Other||Odds Ratio (OR)|1.32||||0.3185||95.0|0.77|2.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Regression, Linear||The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.|
1727147|NCT00588692|3181960|Superiority or Other||||||<|0.9|||||||ANOVA||||
1727148|NCT00588692|3181961|Superiority or Other|||||||0.4|||||||ANOVA||||
1727149|NCT00588692|3181962|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1727079|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.28||||0.2291||95.0|-0.74|0.18||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average paroxysmal pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727080|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.17||||0.4806||95.0|-0.64|0.3||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727081|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.05||||0.6959||95.0|-0.32|0.21||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Average surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727082|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.22||||0.4188||95.0|-0.75|0.31||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727083|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.44||||0.2089||95.0|-1.13|0.25||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727084|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.57||||0.0917||95.0|-1.23|0.09||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Overall unpleasantness: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727085|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.13||||0.6276||95.0|-0.68|0.42||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Heavy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727086|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.44||||0.2181||95.0|-1.15|0.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Aching: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727087|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|0.18||||0.587||95.0|-0.48|0.85||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Throbbing: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727088|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.07||||0.8227||95.0|-0.71|0.57||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Radiating: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727089|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.25||||0.4183||95.0|-0.85|0.36||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Cramping: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727090|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|0.0||||0.999||95.0|-0.54|0.54||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Tingling: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727091|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|0.05||||0.874||95.0|-0.63|0.73||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Electrical: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727092|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.21||||0.3383||95.0|-0.64|0.22||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Numb: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727093|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.41||||0.2318||95.0|-1.08|0.27||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Shocking: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727094|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.09||||0.6871||95.0|-0.55|0.37||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Itchy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727095|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|0.18||||0.5664||95.0|-0.45|0.82||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Tender: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727096|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.09||||0.6941||95.0|-0.53|0.35||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Sensitive: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727097|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|0.12||||0.3966||95.0|-0.16|0.41||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Cold: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727098|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.24||||0.4973||95.0|-0.93|0.46||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Dull: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727099|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.47||||0.0484||95.0|-0.94|0.0||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Hot: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727100|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.5||||0.1065||95.0|-1.11|0.11||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effect models||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Sharp: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727101|NCT00589979|3181799|Superiority or Other||Mean Difference (Net)|-0.22||||0.4498||95.0|-0.8|0.36||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|Intense: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727102|NCT00589979|3181800|Superiority or Other||Mean Difference (Net)|0.39||||0.2747||95.0|-0.31|1.09||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects regression||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727103|NCT00589979|3181801|Superiority or Other||Mean Difference (Net)|-0.54||||0.0224||95.0|-1.01|-0.08||All statistical tests were 2-sided with a significance level of alpha=0.05.|Linear mixed effects model||The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.|The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.|
1727104|NCT00589979|3181802|Superiority or Other||Odds Ratio (OR)|1.86||||0.1272||95.0|0.86|4.02||The logistic regression model for repeated measures used for this analysis included treatment, sequence, period, and first-order carry-over as fixed effects and repeated measures taken on patients nested within sequence.|Regression, Logistic|The results presented are reported in terms of odds ratios, corresponding 95% confidence intervals, and P-values for each fixed effect in the model.|The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.|The proportion of patients who exited from the current treatment period prior to the 4-week planned duration was analyzed using a logistic regression model for repeated measures.|
1727105|NCT00589979|3181804|Superiority or Other||Hazard Ratio (HR)|1.78||||0.1006||95.0|0.89|3.55||All statistical tests were 2-sided with a significance level of alpha=0.05.|Cox frailty model|Model included treatment, sequence, period, and first-order carryover as fixed effects and frailty; patient nested within sequence was frailty.|The Hazard Ratio (HR) provided is the ratio of Placebo to Lidoderm.|The two treatments were compared by time-varying relative hazards, associated P values, and 95% confidence intervals. Appropriate survival or hazard functions were calculated.|
1727106|NCT00589914|3181805|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.74|||2-Sided|95.0|-1.22|1.69||||||The change from baseline was analyzed using an ANCOVA model with factors for treatment and country and baseline score as a covariate.|
1727155|NCT00588692|3181964|Superiority or Other|||||||0.06|||||||ANOVA||||
1727108|NCT00589914|3181807|Non-Inferiority or Equivalence|The non-inferiority margin was 5 points in the change in PANSS total score i.e., lower limit of the 95% CI for difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) had to be greater than -5 to demonstrate non-inferiority.|Mean Difference (Final Values)|0.4|Standard Error of the Mean|1.02|||2-Sided|95.0|-1.62|2.38||||||Null hypothesis: Difference between groups (RISPERDAL CONSTA minus paliperidone palmitate) for the mean change from baseline to endpoint in PANSS total score (LOCF) was less than or equal to -5 (prespecified non-inferiority margin). Sample size: SD of 20 for the change in PANSS total score, a true difference between treatment groups of 0.1 in favor of RISPERDAL CONSTA, 2-sided significance level of 5%, and 80% power. A sample size reestimation was performed when 60% of the data was available.|
1727109|NCT00589797|3181828|Non-Inferiority|The trial was designed as a non-inferiority trial with a margin (delta) of 15%. Additional analyses using a delta of 10% as requested by FDA were also conducted.|||||<|0.05|||||||t-test, 1 sided||||
1727110|NCT00589693|3181830|Superiority or Other||Difference of 2 binomial proportions|6.7|||||2-Sided|95.0|-5.0|18.5|||||||
1727111|NCT00589693|3181831|Superiority or Other|||||||0.14|||||||Fisher Exact||||
1727112|NCT00589693|3181832|Superiority or Other||Difference of 2 binomial proportions|-5.6|||||2-Sided|95.0|-23.0|11.7|||||||
1727113|NCT00589693|3181833|Superiority or Other||Difference of 2 binomial proportions|-18.8|||||2-Sided|95.0|-57.2|19.5|||||||
1727114|NCT00589693|3181834|Non-Inferiority or Equivalence|Noninferiority will be established if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference in clinical cure rate (doripenem minus imipenem-cilastatin) is greater than 15%|Difference of 2 binomial proportions|-11.2|||||2-Sided|95.0|-26.3|3.8||||||Null Hypothesis: The clinical cure rate of doripenem assessed at the EOT visit is more than 15% inferior to that of imipenem-cilastatin|
1727115|NCT00589121|3181905|Superiority or Other|The fixed rate of 37% comes from the published National Cancer Institute of Canada trial SR2 (CAN-NCIC-SR2: Phase III Randomized Study of Pre- vs Postoperative Radiotherapy in Curable Extremity Soft Tissue Sarcoma) receiving preoperative radiation therapy without image-guided radiation therapy (IGRT).||||||0.0005|||||||Fisher Exact|||Initially designed to test for a 20% absolute improvement from 37% (fixed rate) to 17% using Fisher's exact test, requiring 41 patients per cohort (51 with 20% ineligibility) with 5% type I error and 90% statistical power. During accrual, the sample size for cohort B was increased to 66 (83 with 20% ineligibility) to test for a 15% improvement with 5% type I error and 85% power.|
1727116|NCT00589108|3181906|Superiority or Other|||||||0.92|||||||ANOVA|||P-value for the difference between the percentage of knees surviving between the three groups at 5 years post-surgery.|
1727117|NCT00589108|3181907|Superiority or Other|||||||0.08|||||||ANOVA|||P-value for the difference between the Knee Society Stair Climbing Score between the three groups at 5 years post-surgery.|
1727118|NCT00589108|3181907|Superiority or Other|||||||0.44|||||||ANOVA|||P-value for the difference between the Knee Society Stair Climbing Score between the three groups at 2 years post-surgery.|
1727119|NCT00589108|3181908|Superiority or Other|||||||0.87|||||||ANOVA|||P-value for the difference for the Knee Society Pain Score between the three groups at 5 years post-surgery.|
1727120|NCT00589108|3181909|Superiority or Other|||||||0.06|||||||ANOVA|||P-value for the difference for the Knee Society Function Score between the three groups at 5 years post-surgery.|
1727121|NCT00589108|3181910|Superiority or Other|||||||0.8|||||||ANOVA|||P-value for the difference between the mean maximum flexion between the three groups at 5 years post-surgery.|
1727122|NCT00589108|3181910|Superiority or Other|||||||0.64|||||||ANOVA|||P-value for the difference between the mean maximum flexion between the three groups at 2 years post-surgery.|
1727123|NCT00588770|3181948|Superiority|||||||0.22||||||The P value was based on stratified log rank test, stratified by choice of chemotherapy combination, performance status, weight loss in the last 6 months, and prior radiation of the head and neck.|Log Rank|||The study hypothesis is that the addition of bevacizumab will improve the median survival by 35% from 8.5 months (based on E1395 and E5397) to 11.5 months.|
1727124|NCT00588731|3181949|Superiority or Other|||||||0.76|||||||ANOVA||||
1727125|NCT00588731|3181950|Superiority or Other|||||||0.9|||||||ANOVA||||
1727126|NCT00588692|3181951|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1727127|NCT00588692|3181951|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1727128|NCT00588692|3181951|Superiority or Other||||||<|0.9|||||||ANOVA||||
1727129|NCT00588692|3181952|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1727130|NCT00588692|3181952|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1727131|NCT00588692|3181952|Superiority or Other||||||<|0.4|||||||ANOVA||||
1727132|NCT00588692|3181953|Superiority or Other|||||||0.16|||||||t-test, 2 sided||||
1727133|NCT00588692|3181953|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1727134|NCT00588692|3181953|Superiority or Other||||||<|0.11|||||||ANOVA||||
1727135|NCT00588692|3181954|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1727136|NCT00588692|3181954|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1727137|NCT00588692|3181954|Superiority or Other||||||<|0.9|||||||ANOVA||||
1727138|NCT00588692|3181955|Superiority or Other|||||||0.6|||||||ANOVA||||
1727139|NCT00588692|3181956|Superiority or Other|||||||0.24|||||||t-test, 2 sided||||
1727140|NCT00588692|3181956|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1727141|NCT00588692|3181956|Superiority or Other||||||<|0.9|||||||ANOVA||||
1727142|NCT00588692|3181957|Superiority or Other|||||||0.3|||||||ANOVA||||
1727143|NCT00588692|3181958|Superiority or Other|||||||0.9|||||||ANOVA||||
1727144|NCT00588692|3181959|Superiority or Other|||||||0.9|||||||ANOVA||||
1727145|NCT00588692|3181960|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1727146|NCT00588692|3181960|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Within group change compared to baseline|
1727156|NCT00588692|3181966|Superiority or Other||||||<|0.05|||||||ANOVA|||35-49% Ejection Fraction Subgroup|
1727157|NCT00588692|3181966|Superiority or Other||||||<|0.05|||||||ANOVA|||For 25-49% Ejection Fraction Subgroup|
1727158|NCT00588380|3181977|Superiority or Other|||||||0.09|||||||Kruskal-Wallis|||All data are presented as means ± SEM. Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of genotype with ΦTotal|
1727159|NCT00588380|3181978|Superiority or Other|||||||0.11|||||||Kruskal-Wallis|||Using the Kruskal-Wallis test (general allelic model), we assessed univariate associations of rs6923761 genotype with Phi Total in the presence of either glucose alone, glucose and 0.75 pmol/kg/min GLP-1 or glucose and 1.5 pmol/kg/min GLP-1 If the p-value for the overall univariate test of association was <0.1, then the associations for specific genotype pairs (e.g.: 1,1 vs. 1,2 or 2,2 vs. 1,1) were also examined using a Mann-Whitney Rank Sum test.|
1727160|NCT00588354|3181979|Superiority or Other||Mean Difference (Net)|-0.35|Standard Error of the Mean|3.37||0.918|2-Sided|95.0|-6.96|6.26|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.|
1727161|NCT00588354|3181980|Superiority or Other||Mean Difference (Net)|-4.83|Standard Error of the Mean|3.53||0.186|2-Sided|95.0|-11.75|2.09|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.|
1727162|NCT00588354|3181981|Superiority or Other||Mean Difference (Net)|7.04|Standard Error of the Mean|3.17||0.038|2-Sided|95.0|0.83|13.25|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.|
1727163|NCT00588354|3181982|Superiority or Other||Median Difference (Net)|5.86|Standard Error of the Mean|3.28||0.089|2-Sided|95.0|-0.57|12.29|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.|
1727164|NCT00588354|3181983|Superiority or Other||Mean Difference (Net)|5.67|Standard Error of the Mean|2.27||0.022|2-Sided|95.0|1.22|10.12|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.|
1727165|NCT00588354|3181984|Superiority or Other||Mean Difference (Net)|2.96|Standard Error of the Mean|2.04||0.162|2-Sided|95.0|-1.04|6.96|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.|
1727166|NCT00588354|3181985|Superiority or Other||Mean Difference (Net)|0.11|Standard Error of the Mean|0.97||0.91|2-Sided|95.0|-1.79|2.01|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.|
1727167|NCT00588354|3181986|Superiority or Other||Mean Difference (Net)|1.54|Standard Error of the Mean|1.05||0.159|2-Sided|95.0|-0.52|3.6|||ANCOVA|||Data were analyzed using analysis of covariance (ANCOVA) with baseline value included as a covariate.|
1727168|NCT00587834|3182028|Superiority or Other|||||||0.3173|||||||McNemar|McNemar's paired comparison test||Compare participants with (1) Gintuit not sensitive and Control sensitive to (2) Gintuit sensitive and Control not sensitive.|
1727169|NCT00587834|3182029|Superiority or Other||||||<|0.0001|||||||Exact binomial test|||The proportion of Gintuit as the preferred procedure.|
1727170|NCT00587834|3182030|Superiority or Other||||||<|0.0001|||||||Exact binomial test|||Superiority relative to a pre-defined threshold (80%) success|
1727171|NCT00587834|3182031|Superiority or Other||||||<|0.0001|||||||McNemar|||Compare participants with (1)Gintuit equally firm and Control not equally firm to (2) Gintuit not equally firm and Control equally firm|
1727172|NCT00587834|3182032|Superiority or Other||||||<|0.0001|||||||McNemar|||Compare participants with (1) Gintuit equally red and Control not equally red to (2) Gintuit not equally red and Control equally red|
1727173|NCT00587834|3182033|Superiority or Other||||||<|0.0001|||||||Exact Bionomial Test|||Superiority relative to a pre-defined standard (50% success)|
1727174|NCT00587678|3182037|Superiority or Other|||||||0.85|||||||Linear repeated measures model||||
1727175|NCT00587678|3182038|Superiority or Other|||||||0.77|||||||Linear repeated measures model||||
1727176|NCT00587678|3182039|Superiority or Other||||||=|0|||||||linear repeated measures model||||
1727177|NCT00587678|3182040|Superiority or Other||||||<|0.05|||||||Linear repeated measures model||||
1727178|NCT00587678|3182041|Superiority or Other|||||||0.68|||||||Linear repeated measures model||||
1727179|NCT00587678|3182042|Superiority or Other|||||||0.78|||||||Linear repeated measures model||||
1727180|NCT00587678|3182043|Superiority or Other||||||<|0.05||||||vs. baseline|Linear repeated measures model||||
1727181|NCT00587678|3182043|Superiority or Other||||||<|0.37|||||||Linear repeated measures model||||
1727182|NCT00587678|3182044|Superiority or Other|||||||0.67|||||||Linear repeated measures model||||
1727183|NCT00587678|3182045|Superiority or Other|||||||0.71|||||||Linear repeated measures model||||
1727184|NCT00587678|3182046|Superiority or Other||||||<|0.05||||||vs. baseline|Linear repeated measures model||||
1727185|NCT00587678|3182046|Superiority or Other||||||<|0.31|||||||Linear repeated measures model||||
1727186|NCT00587678|3182047|Superiority or Other||||||<|0.01||||||vs. baseline|Linear repeated measures model||||
1727187|NCT00587678|3182047|Superiority or Other||||||<|0.32|||||||Linear repeated measures model||||
1727188|NCT00587587|3182050|Superiority or Other|||||||0.9556|||||||Wilcoxon (Mann-Whitney)|||Differences evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.|
1727189|NCT00587587|3182051|Superiority or Other|||||||0.408|||||||Wilcoxon (Mann-Whitney)|||Global assessments analyzed as ordinal ranks. Treatment differences in global assessment evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.|
1727190|NCT00587587|3182052|Superiority or Other|||||||0.7221|||||||Wilcoxon (Mann-Whitney)|||Global assessments analyzed as ordinal ranks. Treatment differences in global assessment evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.|
1727191|NCT00587587|3182053|Superiority or Other|||||||0.167|||||||Wilcoxon (Mann-Whitney)|||Treatment differences in scar thickness evaluated using a 2-tailed Wilcoxon rank sum test|
1727192|NCT00587587|3182054|Superiority or Other|||||||0.7149|||||||Wilcoxon (Mann-Whitney)|||Treatment differences in scar firmness evaluated using a 2-tailed Wilcoxon rank sum test with pooled variances.|
1727193|NCT00587587|3182055|Superiority or Other|||||||0.3783|||||||Fisher Exact||||
1727195|NCT00587587|3182057|Superiority or Other|||||||1||||||"P-value compares overall incidence of AEs between groups, ie Apligraf 12/17 and Control 10/13.~UADE is defined in 21CFR812.3(s)"|Fisher Exact|||Fisher's exact test used to evaluate treatment differences between Apligraf subjects and Control subjects experiencing any AEs.|
1727196|NCT00587483|3182063|Superiority or Other||Odds Ratio (OR)|0.82||||0.424|2-Sided|95.0|0.52|1.33|||Regression, Logistic||||
1727197|NCT00587483|3182063|Superiority or Other||Odds Ratio (OR)|0.51||||0.008|2-Sided|95.0|0.32|0.84|||Regression, Logistic||||
1727198|NCT00587483|3182063|Superiority or Other||Odds Ratio (OR)|0.74||||0.215|2-Sided|95.0|0.45|1.19|||Regression, Logistic||||
1727199|NCT00587483|3182064|Superiority or Other||Odds Ratio (OR)|0.8||||0.433|2-Sided|95.0|0.47|1.37|||Regression, Logistic||||
1727200|NCT00587483|3182064|Superiority or Other||Odds Ratio (OR)|0.65||||0.117|2-Sided|95.0|0.39|1.11|||Regression, Logistic||||
1727201|NCT00587483|3182064|Superiority or Other||Odds Ratio (OR)|0.81||||0.427|2-Sided|95.0|0.48|1.37||An alpha of 0.0167 was used to account for multiple comparisons among the 3 groups. Given the total of 3 comparisons, 0.05/3 = 0.0167 was used in the calculation.|Regression, Logistic|||The expected overall incidence of ventricular fibrillation after removal of the aortic clamp is at least 70%. Using a chi square analysis with 80% power and an alpha of 0.0167, we estimate that we will need 113 patients in each group to show a 30% reduction in the incidence of ventricular fibrillation with amiodarone.|
1727202|NCT00587288|3182078|Superiority or Other|||||||0.0809|||||||Log Rank|The p value for the treatment comparison was based on log rank test adjusting for stratification factor (ie, ACQ score ≤2 and >2).||Kaplan-Meier estimate of time to first CAE. (First quartile, median and third quartile “survival” times with 95% confidence intervals (ie, time to first CAE) could not be estimated since the proportion of patients experiencing CAE was too low. Therefore, the only number presented in regard to the Kaplan-Meier analysis is the p-value of the log-rank test, below. )|
1727203|NCT00587288|3182078|Superiority or Other||Odds Ratio (OR)|0.33||||0.0833|2-Sided|95.0|0.1|1.15||The p-value for the treatment comparison was based on logistic regression with adjustment for stratification factor.|Regression, Logistic||||
1727204|NCT00587288|3182079|Superiority or Other||Adjusted mean difference|-125.29|Standard Error of the Mean|44.885||0.0068|2-Sided|95.0|-214.81|-35.77||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline. The difference between reslizumab 3.0 mg/kg and placebo groups was from comparison of the least square means.|ANCOVA||||
1727205|NCT00587288|3182080|Superiority or Other||Adjusted mean difference|7.98|Standard Error of the Mean|2.36||0.001|2-Sided|95.0|3.3|12.65||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA||||
1727206|NCT00587288|3182081|Superiority or Other||Adjusted mean difference|0.24|Standard Error of the Mean|0.077||0.0023|2-Sided|95.0|0.088|0.392||The p-value for the treatment comparison was based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA||||
1727207|NCT00587288|3182082|Superiority or Other||Odds Ratio (OR)|2.01||||0.0848|2-Sided|95.0|0.91|4.46||The p-value for the treatment comparison was based on logistic regression with adjustment for stratification factor.|Regression, Logistic||||
1727208|NCT00587288|3182083|Superiority or Other||Adjusted mean difference|-0.38|Standard Error of the Mean|0.194||0.0541|2-Sided|95.0|-0.76|0.01||The p-value for the treatment comparison is based on the ANCOVA with adjustment for stratification factor and for variable at baseline.|ANCOVA||||
1727209|NCT00587158|3182102|Superiority or Other|||||||0.04|||||||t-test, 2 sided|||The number of subjects with moderate to mild interstitial fibrosis (Banff ci score greater than or equal to 2) at one year was compared between treatment groups.|
1727210|NCT00587158|3182102|Superiority or Other|||||||1|||||||t-test, 2 sided|||The number of subjects with mild interstitial fibrosis (Banff ci score > 0 and < 2) at one year was compared between treatment groups.|
1727211|NCT00587158|3182103|Superiority or Other|||||||0.11|||||||t-test, 2 sided||||
1727212|NCT00587158|3182104|Superiority or Other|||||||0.66|||||||t-test, 2 sided||||
1727213|NCT00587158|3182105|Superiority or Other|||||||0.66|||||||t-test, 2 sided||||
1727214|NCT00587158|3182108|Superiority or Other|||||||0.41|||||||t-test, 2 sided||||
1727215|NCT00587158|3182109|Superiority or Other|||||||0.98|||||||t-test, 2 sided||||
1727216|NCT00587158|3182110|Superiority or Other|||||||0.171|||||||Wilcoxon (Mann-Whitney)|||The median BAP level at one year was compared between the two treatment groups.|
1727217|NCT00587158|3182110|Superiority or Other|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||The median BAP level at 90 days was compared between the two treatment groups.|
1727218|NCT00587158|3182110|Superiority or Other|||||||0.553|||||||Wilcoxon (Mann-Whitney)|||The median BAP level at 21 days was compared between the two treatment groups.|
1727219|NCT00587158|3182110|Superiority or Other|||||||0.833|||||||Wilcoxon (Mann-Whitney)|||The median BAP level at baseline was compared between the two treatment groups.|
1727220|NCT00587158|3182111|Superiority or Other|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|||The median PTH level at one year was compared between the two treatment groups.|
1727221|NCT00587158|3182111|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The median PTH level at 90 days was compared between the two treatment groups.|
1727222|NCT00587158|3182111|Superiority or Other||||||<|0.005|||||||Wilcoxon (Mann-Whitney)|||The median PTH level at 21 days was compared between the two treatment groups.|
1727223|NCT00587158|3182111|Superiority or Other||||||<|0.17|||||||Wilcoxon (Mann-Whitney)|||The median PTH level at baseline was compared between the two treatment groups.|
1727224|NCT00587158|3182112|Superiority or Other|||||||0.229|||||||Fisher Exact||||
1727225|NCT00587158|3182113|Superiority or Other|||||||0.4571|||||||Fisher Exact||||
1727226|NCT00587158|3182114|Superiority or Other|||||||0.0005|||||||Fisher Exact||||
1727227|NCT00587041|3182122|Superiority or Other|||||||0.3|||||||t-test, 1 sided|||Ranked-sum T-Test for Oxadrop group CaOX SS comparison between 0 and 6 weeks|
1727228|NCT00587041|3182122|Superiority or Other|||||||0.67|||||||t-test, 1 sided|||Ranked sum T-test for AKSB group CaOX SS comparison between 0 and 6 weeks|
1727229|NCT00587041|3182122|Superiority or Other|||||||0.045|||||||t-test, 1 sided|||Ranked sum T-test for placebo group CaOx SS comparison between 0 and 6 weeks|
1727230|NCT00587041|3182122|Superiority or Other|||||||0.3|||||||Kruskal-Wallis|||80% power for 0.66 DG difference from placebo. The reported value is the overall p-value for CaOx supersaturation by Kruskal-Wallis test of equal change across all three groups, no pair-wise comparison.|
1727231|NCT00586820|3182157|Superiority or Other|||||||0.007|||||||t-test, 2 sided|||Change between the groups from immediate pre-PCI and 16 hours post-PCI.|
1727232|NCT00586820|3182157|Superiority or Other|||||||0.019|||||||t-test, 2 sided|||Change between the groups from immediate pre-PCI and 8 hours post PCI.|
1727233|NCT00586820|3182158|Superiority or Other|||||||0.029|||||||t-test, 2 sided||||
1727234|NCT00586521|3182216|Superiority or Other|||||||0.314||||||The alpha level for a significant P-value was pre-defined at 5%.|paired t-test|||"The Haemo-QoL A questionnaire measures the subject's self-assessment of disease impact on physical functioning, role functioning, worry, consequences, positive affect, and treatment concern."|
1727235|NCT00586521|3182217|Superiority or Other||||||<|0.001|||||||paired t-test|||The Gilbert Score was the sum of 3 scores: pain (0=no pain to 3=severe pain); bleeding score (0=none to 3=3 or more major bleeds or 7 or more minor bleeds); and physical score (based on swelling, muscle atrophy; and axial deformity (at knee or ankle), range of motion, crepitus on motion, flexion contracture, instability.|
1727236|NCT00586521|3182218|Superiority or Other||||||<|0.001|||||||paired t-test|||paired t-test (prophylaxis compared to on-demand) at 6 months of treatment.|
1727237|NCT00586521|3182219|Superiority or Other||||||<|0.001|||||||paired t-test|||The maximum individual reduction in the actual number of joint bleeds after the switch to prophylactic treatment was analyzed by a paired t-test of the individual difference between prophylaxis treatment bleed compared to on-demand treatment bleeds.|
1727238|NCT00586521|3182219|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The primary outcome measure was analyzed by paired t-test and Wilcoxon test (number of joint bleeds prophylaxis treatment compared to number of joint bleeds on-demand treatment) at 6 months of treatment.|
1727239|NCT00586482|3182227|Superiority or Other|||||||1|||||||Fisher Exact||||
1727240|NCT00586482|3182228|Superiority or Other|||||||0.93|||||||t-test, 2 sided||||
1727241|NCT00586482|3182229|Superiority or Other|||||||0.29|||||||t-test, 2 sided||||
1727242|NCT00586482|3182230|Superiority or Other|||||||0.23|||||||Fisher Exact||||
1727243|NCT00586482|3182231|Superiority or Other|||||||0.12|||||||t-test, 2 sided|||A two-sided p value of less than or equal to 0.05 was considered statistically significant.|
1727244|NCT00586196|3182282|Superiority or Other||Effect Size|-0.2|||||2-Sided|95.0|-1.5|1.2|||||||
1727245|NCT00586196|3182283|Superiority or Other||Odds Ratio (OR)|0.9|||||2-Sided|95.0|0.4|2.3|||||||
1727246|NCT00586157|3182286|Superiority or Other|||||||0.003|||||||Z-test||||
1727247|NCT00586157|3182287|Superiority or Other|||||||0.001|||||||Z-test||||
1727248|NCT00586157|3182288|Superiority or Other||||||<|0.001|||||||Z-test||||
1727249|NCT00585468|3182359|Superiority or Other|||||||0.9607|||||||t-test, 2 sided||||
1727250|NCT00585468|3182361|Superiority or Other|||||||0.9669|||||||t-test, 2 sided||||
1727251|NCT00585468|3182362|Superiority or Other|||||||0.4937|||||||t-test, 2 sided||||
1727252|NCT00585468|3182363|Superiority or Other|||||||0.146|||||||t-test, 2 sided||||
1727253|NCT00585468|3182365|Superiority or Other|||||||0.039|||||||t-test, 2 sided||||
1727254|NCT00585468|3182366|Superiority or Other|||||||0.0163|||||||t-test, 2 sided||||
1727255|NCT00585013|3182397|Superiority or Other||||||>|0.05||||||Applies to all time points.|Wilcoxon (Mann-Whitney)||||
1727256|NCT00585013|3182398|Superiority or Other||||||<|0.05||||||This applies to time points at 12 h and 24 h.|Wilcoxon (Mann-Whitney)||||
1727257|NCT00585013|3182398|Superiority or Other||||||>|0.05||||||This applies to measurements at preoperative, 0 h, and 48 h time points.|Wilcoxon (Mann-Whitney)||||
1727258|NCT00585013|3182399|Superiority or Other||||||<|0.05||||||This applies to measurements at time points 12 h, 24 h, and 48 h.|Wilcoxon (Mann-Whitney)||||
1727259|NCT00585013|3182399|Superiority or Other||||||>|0.05||||||This applies for measurements at preoperative and 0 h time points.|Wilcoxon (Mann-Whitney)||||
1727260|NCT00585013|3182400|Superiority or Other||||||>|0.05||||||This p value applies to all time points for all variables.|Wilcoxon (Mann-Whitney)||||
1727261|NCT00584831|3182422|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|Standard Deviation|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727262|NCT00584831|3182422|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|Standard Deviation|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727263|NCT00584831|3182422|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.05|Standard Deviation|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727264|NCT00584831|3182422|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|Standard Deviation|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727265|NCT00584831|3182422|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|Standard Deviation|0.19||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727266|NCT00584831|3182422|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.04|Standard Deviation|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727267|NCT00584831|3182423|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|Standard Deviation|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727268|NCT00584831|3182423|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|Standard Deviation|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727269|NCT00584831|3182423|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|Standard Deviation|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727270|NCT00584831|3182423|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|Standard Deviation|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727271|NCT00584831|3182423|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|Standard Deviation|0.15||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727272|NCT00584831|3182423|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.03|Standard Deviation|0.13||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727273|NCT00584831|3182424|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|Standard Deviation|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727274|NCT00584831|3182424|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|Standard Deviation|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727275|NCT00584831|3182424|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.03|Standard Deviation|0.19||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727276|NCT00584831|3182424|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.03|Standard Deviation|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727277|NCT00584831|3182424|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.01|Standard Deviation|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727278|NCT00584831|3182424|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.02|Standard Deviation|0.16||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727279|NCT00584831|3182425|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.02|Standard Deviation|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727280|NCT00584831|3182425|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|Standard Deviation|0.18||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727281|NCT00584831|3182425|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.06|Standard Deviation|0.17||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727282|NCT00584831|3182425|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.02|Standard Deviation|0.2||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727283|NCT00584831|3182425|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|-0.04|Standard Deviation|0.18||0.02||95.0|||||ANOVA|||Hyposthesis is that visual acuity is the same for all lens types.|
1727284|NCT00584831|3182425|Non-Inferiority or Equivalence|The non-inferiority margin is 0.05|Mean Difference (Final Values)|0.03|Standard Deviation|0.16||0.02||95.0|||||ANOVA|||Hypothesis is that visual acuity is the same for all lens types.|
1727285|NCT00584727|3182440|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.|
1727286|NCT00584727|3182441|Superiority or Other||Mean Difference (Final Values)|0.489|Standard Error of the Mean|0.1393||||95.0|0.1529|0.489|||||Mean difference was senofilcon A toric minus alphafilcon A toric|Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric.|
1727287|NCT00584727|3182442|Superiority or Other|||||||0.1328|||||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees|
1727288|NCT00584727|3182443|Superiority or Other|||||||0.2161|||||||Chi-squared|||Aletrnative hypothesis was senofilcon A toric was superior to alphafilcon A toric by having more eyes within 5 degrees.|
1727289|NCT00584727|3182444|Superiority or Other||Mean Difference (Final Values)|0.7155|Standard Error of the Mean|0.1334||||95.0|0.3625|0.7155|||||Mean difference was senofilcon A toric minus etafilcon A sphere.|Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere.|
1727290|NCT00584727|3182445|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Alternative hypothesis was senofilcon A toric was superior to etafilcon A sphere by having more eyes see 20/20|
1727291|NCT00584701|3182446|Superiority or Other||Dfiference in exon expression|1.5|||<|0.001||||||"Expression difference >|1.5| with p-value adjusted for multiple comparisons."|ANCOVA|Between-group gene expression profiles compared between high versus low responders, controlling for age, gender and batch.|||
1727292|NCT00584077|3182464|Superiority or Other||||||<|0.01||||||P value was adjusted for multiple comparisons using Bonferroni test|ANOVA|||For the cross-sectional and longitudinal groups, a comparison of cough frequency after airway irritation of the main carina, and the proximal and distal anastomotic sites was performed using one-way analysis of variance with Bonferroni test. In the longitudinal cohort, a comparison of the cough frequencies at different airway sites at 1.5 and 12 months was performed using one-way analysis of variance with Bonferroni test.|
1727293|NCT00584077|3182465|Superiority or Other||||||<|0.01|||||||ANOVA|||Each subject served as their own control as a comparison of the airway innervated (contralateral native lung) with the denervated airway (allograft)|
1727294|NCT00583908|3182482|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Deviation|2.6||0.73||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omifilcon A||
1727295|NCT00583908|3182482|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Deviation|6.0||0.85||95.0|||||t-test, 1 sided||Mean difference is senofilocon A minus lotrafilcon B||
1727296|NCT00583908|3182482|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Deviation|3.7||0.27||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A||
1727297|NCT00583908|3182483|Superiority or Other||Mean Difference (Final Values)|-6.4|Standard Deviation|5.6||0.0058||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A||
1727298|NCT00583908|3182483|Superiority or Other||Mean Difference (Final Values)|-2.9|Standard Deviation|3.1||0.0049||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B||
1727299|NCT00583908|3182483|Superiority or Other||Mean Difference (Final Values)|-6.0|Standard Deviation|6.8||0.008||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A||
1727300|NCT00583908|3182484|Superiority or Other||Mean Difference (Final Values)|1.1|Standard Deviation|5.8||0.56||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A||
1727301|NCT00583908|3182484|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Deviation|5.0||0.89||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B||
1727302|NCT00583908|3182484|Superiority or Other||Mean Difference (Final Values)|-1.4|Standard Deviation|3.5||0.17||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A||
1727303|NCT00583908|3182485|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Deviation|3.6||0.38||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A||
1727304|NCT00583908|3182485|Superiority or Other||Mean Difference (Final Values)|0.8|Standard Deviation|3.9||0.47||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B||
1727305|NCT00583908|3182485|Superiority or Other||Mean Difference (Final Values)|-3.9|Standard Deviation|6.8||0.061||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A||
1727306|NCT00583908|3182486|Superiority or Other||Median Difference (Final Values)|-3.0|Standard Deviation|6.3||0.16||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A||
1727307|NCT00583908|3182486|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Deviation|4.3||0.31||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B||
1727308|NCT00583908|3182486|Superiority or Other||Mean Difference (Final Values)|-3.1|Standard Deviation|6.5||0.11||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A||
1727309|NCT00583908|3182487|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Deviation|7.6||0.78||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A||
1727310|NCT00583908|3182487|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Deviation|6.3||0.68||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B||
1727311|NCT00583908|3182487|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Deviation|6.5||0.78||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A||
1727312|NCT00583908|3182488|Superiority or Other||Mean Difference (Final Values)|-1.5|Standard Deviation|5.9||0.44||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A||
1727313|NCT00583908|3182488|Superiority or Other||Mean Difference (Final Values)|1.4|Standard Deviation|4.7||0.31||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B||
1727314|NCT00583908|3182488|Superiority or Other||Median Difference (Final Values)|-3.1|Standard Deviation|5.0||0.044||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A||
1727315|NCT00583908|3182489|Superiority or Other||Mean Difference (Final Values)|-3.3|Standard Deviation|4.4||0.044||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus omafilcon A||
1727316|NCT00583908|3182489|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Deviation|3.5||0.73||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus lotrafilcon B||
1727317|NCT00583908|3182489|Superiority or Other||Mean Difference (Final Values)|-2.7|Standard Deviation|6.5||0.16||95.0|||||t-test, 1 sided||Mean difference is senofilcon A minus balafilcon A||
1727318|NCT00583908|3182490|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Deviation|0.14||0.015||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus omafilcon A|Alternative hypothesis was senofilcon A toric was superior to omafilcon A toric by having a lower logMAR score|
1727319|NCT00583908|3182490|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Deviation|0.09||0.052||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus lotrafilcon B|Alternative hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having a lower logMAR score|
1727320|NCT00583908|3182490|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Deviation|0.15||0.0083||95.0|||||t-test, 1 sided||Mean difference was senofilcon A minus balafilcon A|Alternative hypothesis was senofilcon A toric was superior to balafilcon A toric by having a lower logMAR score|
1727321|NCT00583908|3182491|Superiority or Other||Mean Difference (Final Values)|-27.0|Standard Deviation|12.4|<|0.0001||95.0||||paired t-test|t-test, 1 sided||Mean difference is senofilcon A minus omafilcon A|Hypothesis was senofilcon A toric was superior to omafilcon A toric by having less degree of rotation|
1727322|NCT00583908|3182491|Superiority or Other||Mean Difference (Final Values)|-15.4|Standard Deviation|17.8|<|0.0002||95.0||||paired t-test|t-test, 1 sided||mean difference is senofilcon A minus lotrafilcon B|Hypothesis was senofilcon A toric was superior to lotrafilcon B toric by having less degree of rotation|
1727323|NCT00583908|3182491|Superiority or Other||Mean Difference (Final Values)|-27.5|Standard Deviation|17.1|<|0.0001||95.0||||Paired t-test|t-test, 1 sided||mean difference was senofilcon A minus balafilcon A|Alternative Hypothesis was senofilcon A toric was superior to balafilcon A toric by having less degrees of rotation|
1727324|NCT00583661|3182505|Non-Inferiority or Equivalence|Sample size determination: A sample of 24 subjects followed for approximately 100 days provides greater than 80% power to conclude that, with a 1-sided alpha=0.025 test, the SAE rate of the EXCOR (assumed to be 0.21 per patient-day) is less than 0.25 per patient-day. This sample size was estimated using 10,000 simulations of this study. A total enrollment of 48 subjects (24 per cohort) were enrolled and implanted with the EXCOR® Pediatric.|Poisson confidence interval|0.25|||<|0.05|2-Sided|95.0|0.0|0.25||A Poisson exact confidence interval was calculated and the critical-value method was used for the significance testing. Success was defined as the upper bound of the 95% Poisson exact confidence interval being less than 0.25.|Poisson confidence interval|||Ho: EXCOR® SAE Rate >=0.25 Ha: EXCOR® SAE Rate < 0.25 Where serious adverse event (SAE) rate is calculated as the total number of serious adverse events divided by the sum of days all patients are on the EXCOR® Pediatric device, and 0.25 serious adverse events per patient-day is the success criterion. Study success in terms of safety will be demonstrated by the upper bound of a two-sided 95% Poisson exact confidence interval being less than 0.25.|
1727325|NCT00583453|3182519|Superiority or Other|||||||0.036||||||treatment x day interaction P = 0.036 Treatment main effect (average day 1 to 10) P = 0.003|Wilcoxon (Mann-Whitney)||||
1727326|NCT00583453|3182521|Superiority or Other|||||||0.214||||||Treatment x day interaction = 0.214|Wilcoxon (Mann-Whitney)||||
1727327|NCT00583453|3182522|Superiority or Other|||||||0.018||||||Treatment x day interaction reported as 0.018.|Wilcoxon (Mann-Whitney)||||
1727328|NCT00583453|3182523|Superiority or Other|||||||0.674||||||Treatment x day interaction|Wilcoxon (Mann-Whitney)||||
1727329|NCT00583219|3182552|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months|
1727330|NCT00583219|3182552|Superiority or Other|||||||0.007|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month.|
1727331|NCT00583219|3182553|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months|
1727332|NCT00583219|3182553|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to one month|
1727333|NCT00583219|3182554|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months.|
1727334|NCT00583219|3182554|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month|
1727335|NCT00583219|3182555|Superiority or Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline|
1727336|NCT00583219|3182556|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to one month|
1727337|NCT00583219|3182558|Superiority or Other|||||||0.25|||||||exact binomial sign test|||P value change from baseline to 3 months|
1727338|NCT00583219|3182558|Superiority or Other||||||>|0.99|||||||Exact binomial sign test|||P value change from baseline to 1 month|
1727339|NCT00583219|3182559|Superiority or Other|||||||0.033|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months|
1727340|NCT00583219|3182559|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month|
1727341|NCT00583219|3182560|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months|
1727342|NCT00583219|3182560|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month|
1727343|NCT00583219|3182561|Superiority or Other|||||||0.22|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline|
1727344|NCT00583219|3182562|Superiority or Other|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline|
1727345|NCT00583219|3182564|Superiority or Other|||||||0.43|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months|
1727346|NCT00583219|3182564|Superiority or Other|||||||0.21|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 1 month|
1727347|NCT00583219|3182565|Superiority or Other|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline to 3 months|
1727348|NCT00583219|3182565|Superiority or Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||P value change from baseline at one month|
1727349|NCT00582907|3182575|Superiority or Other||Median Difference (Net)|-5.0||||0.089|2-Sided|95.0|-15.0|-1.0|||Signed rank|||Null hypothesis: There are no significant differences in the proportion of time participants were treated with rilonacept and placebo. As a secondary measure there were no power calculations.|
1727350|NCT00582907|3182576|Superiority or Other||Median Difference (Net)|2.5||||0.136|2-Sided|95.0|-2.3|9.8|||Signed rank|||Null hypothesis: There are no significant differences in the FMF Armenian Evaluation (severity) Score between rilonacept and placebo. As a secondary measure there were no power calculations.|
1727351|NCT00582907|3182577|Superiority or Other||Median Difference (Net)|-4.2||||0.42|2-Sided|95.0|-6.8|3.9|||Signed Rank||||
1727352|NCT00582907|3182577|Superiority or Other||Median Difference (Net)|-6.5||||0.021|2-Sided|95.0|-11.1|-2.3|||Signed rank|||Null hypothesis: There are no significant differences in the physical health-related quality of life between rilonacept and placebo. As a secondary measure there were no power calculations.|
1727353|NCT00582907|3182578|Superiority or Other||Median Difference (Net)|0.0||||0.5|2-Sided|95.0|-4.0|0.0|||Signed Rank|||Null hypothesis: There are no differences between the treatment arms in the serum amyloid A levels. Since this was a secondary outcome no power calculations were performed.|
1727354|NCT00582907|3182579|Superiority or Other||Median Difference (Net)|108.0||||0.063|2-Sided|95.0|6.5|139.5|||Signed Rank|||Null hypothesis: There are no differences between the treatment arms in the fibrinogen level. Since this was a secondary outcome no power calculations were performed.|
1727355|NCT00582907|3182580|Superiority or Other||Median Difference (Net)|29.4||||0.078|2-Sided|95.0|0.4|78.1|||Signed Rank|||Null hypothesis: There were no differences between the platelet count between the rilonacept and placebo courses. Since this was a secondary outcome no power calculations were performed.|
1727356|NCT00582907|3182581|Superiority or Other||Median Difference (Net)|0.04||||0.22|2-Sided|95.0|-0.03|0.29|||Signed Rank|||Null hypothesis: There are no differences in the C-reactive protein levels between the treatment courses. Since this was a secondary outcome measure no power calculations were performed.|
1727357|NCT00582907|3182582|Superiority or Other||Median Difference (Net)|6.5||||0.156|2-Sided|95.0|-0.5|12.5|||Signed Rank|||Null hypothesis: There are no significant differences in the erythrocyte sedimentation rate between rilonacept and placebo. As a secondary measure there were no power calculations.|
1727358|NCT00582907|3182583|Superiority or Other||Log Rank|0.009||||0.009||95.0|||||Kaplan-Meier survival analysis|||Null hypothesis: There were no significant differences between rilonacept and placebo in the number of days from the start of the treatment course until the development of the a second attack.|
1727359|NCT00582907|3182584|Superiority or Other||Difference in percent of courses|40.0||||0.006||95.0|||||McNemar|||Null hypothesis: There are no significant differences in the number of treatment courses attaining at least a 50% decrease in attacks when compared to baseline between rilonacept and placebo courses.Since this was a secondary measure there were no power calculations.|
1727360|NCT00582907|3182585|Superiority or Other||Differences in percent of courses|29.0||||0.004||95.0|||||McNemar|||Null hypothesis: There are no significant differences in the number of treatment courses without attacks between rilonacept and placebo. As a secondary measure there were no power calculations.|
1727396|NCT00581386|3182712|Superiority or Other||Odds Ratio (OR)|3.81||||0.003||95.0|1.57|9.29|||Odds ratio||||
1727361|NCT00582907|3182586|Superiority or Other||Mean Difference (Net)|-1.2|Standard Deviation|0.5||0.32||95.0|-2.4|0.5|||Signed rank|||Null hypothesis: There were no significant differences in the length of attacks during rilonacept vs. placebo treatment courses. Since this was a secondary outcome there were no power calculations performed.|
1727362|NCT00582907|3182587|Superiority or Other||Median Difference (Net)|0.0||||0.13|2-Sided|95.0|-0.56|0.17|||Signed rank|||Null hypothesis: There were no significant differences between rilonacept and placebo in the occurence of infections. No power calculations for this outcome.|
1727363|NCT00582907|3182587|Superiority or Other||Median Difference (Net)|0.0|Standard Deviation|1.26||0.047|2-Sided|95.0|-4.0|0.0|||Signed rank|||Null hypothesis: There were no significant differences between rilonacept and placebo in the occurence of injection site reactions. No power calculations for this outcome.|
1727364|NCT00582907|3182588|Superiority or Other||Odds Ratio (OR)|0.59|Standard Deviation|0.12||||95.0|0.39|0.85|||||Attacks while receiving rilonacept is the numerator and attacks while receiving placebo is the denominator. In Bayesian statistics credible interval equals confidence interval.|This analysis was done by Bayesian Statistics using a non-informative (neutral) prior (log normal distribution mean 9 [SD 10]). The null hypothesis was that the rilonacept/placebo FMF odds ratio of attacks was 1.|
1727365|NCT00582907|3182588|Superiority or Other||Risk Ratio, log|-1.7|Standard Deviation|0.78||0.027|2-Sided|95.0|-3.4|-0.1|||Signed rank|||Based upon FMF colchicine controlled studies showing an ~80% decrease in attacks, we estimated, based on baseline attacks every 4 weeks, there would be a difference of 0.5 attacks per month between rilonacept and placebo. With a two-sided 5% significance level and power of 80% we aimed for 14 evaluable participants who completed at least 2 treatment courses. The null hypothesis is that there would be no significant differences in the number of attacks between use of rilonacept and placebo.|
1727366|NCT00582309|3182648|Non-Inferiority or Equivalence|Original Power Analysis: The expected differences in mean blood glucose concentration between groups are > 30 mg/dL. Assuming two-tailed alpha of .05, a standard deviation of approximately 40, and a one-to-one allocation and no subject attrition, fifty patients per treatment group (150 total) will be sufficient to achieve 90% power for group mean comparisons allowing for multiple comparisons.|||||<|0.05||||||All results obtained by ANOVA are verified by the nonparametric Kruskal-Wallis test. Statistical significance will be judged by P-values < 0.05.|ANOVA|||Demographic and baseline measurements are reported as either means and standard deviations or as frequency and percentages. These and the outcome measures are compared among the three groups by 1-way analysis of variance (ANOVA) for means or by Fisher’s Exact test for frequencies as appropriate. If there is an overall significant difference, the post hoc multiple comparisons will be done by Fisher’s least significant difference method.|
1727367|NCT00582114|3182656|Superiority or Other||Hazard Ratio (HR)|1.61||||0.002|2-Sided|95.0|1.18|2.19|||Mixed Models Analysis|||All-cause hospitalizations between groups were analyzed. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals.|
1727368|NCT00582114|3182656|Superiority or Other||Hazard Ratio (HR)|3.13||||0.02|2-Sided|95.0|1.08|10.99|||Mixed Models Analysis|||Hospitalization for congestive heart failure between groups was analyzed. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals.|
1727369|NCT00582114|3182656|Superiority or Other||Hazard Ratio (HR)|2.29||||0.02|2-Sided|95.0|1.07|5.21|||Mixed Models Analysis|||As a post hoc analysis, we determined the narrower definition of cardiovascular events per group that included myocardial infarction, stroke, congestive heart failure or cardiovascular death. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals (95% CIs).|
1727370|NCT00582114|3182656|Superiority or Other||Hazard Ratio (HR)|2.36||||0.001|2-Sided|95.0|1.36|4.23|||Mixed Models Analysis|||Cardiovascular events were counted by subject and included the following: myocardial infarction, stroke, hospitalization for congestive heart failure, hospitalized angina, arrhythmias, cardiac arrest, coronary revascularization and heart valve replacement. The duration of participation in the study per subject, which according to the trial design could be up to 12 months, was determined. Incidence rate ratio (IRR) by treatment was then determined along with the 95%confidence intervals (95% CIs).|
1727371|NCT00581555|3182692|Superiority or Other|||||||0.1196||||||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|Pearson chi-square or Fisher exact test|Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.||Analysis from baseline to Week 24.|
1727372|NCT00581555|3182693|Superiority or Other||Mean Difference (Final Values)|2.4|Standard Error of the Mean|1.1||0.031|2-Sided|95.0|0.2|4.6||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 24.|
1727373|NCT00581555|3182693|Superiority or Other||Mean Difference (Final Values)|3.0|Standard Error of the Mean|1.0||0.005|2-Sided|95.0|0.9|5.0||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 20.|
1727374|NCT00581555|3182693|Superiority or Other||Mean Difference (Final Values)|2.6|Standard Error of the Mean|1.0||0.008|2-Sided|95.0|0.7|4.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 16.|
1727375|NCT00581555|3182693|Superiority or Other||Mean Difference (Final Values)|1.0|Standard Error of the Mean|0.9||0.3|2-Sided|95.0|-0.9|2.8||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 12.|
1727504|NCT00578968|3182996|Superiority or Other|||||||0.06|||||||ANOVA||||
1727505|NCT00578968|3182997|Superiority or Other|||||||0.005|||||||ANOVA||||
1727376|NCT00581555|3182693|Superiority or Other||Mean Difference (Final Values)|0.7|Standard Error of the Mean|0.9||0.441|2-Sided|95.0|-1.1|2.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 10.|
1727377|NCT00581555|3182693|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.9||0.968|2-Sided|95.0|-1.8|1.8||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 8.|
1727378|NCT00581555|3182693|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|2.2||0.844|2-Sided|95.0|-4.8|3.9||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 6.|
1727379|NCT00581555|3182693|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|1.3||0.41|2-Sided|95.0|-3.6|1.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 4.|
1727380|NCT00581555|3182693|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|1.2||0.956|2-Sided|95.0|-2.3|2.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from baseline to Week 2.|
1727381|NCT00581555|3182694|Superiority or Other||Mean Difference (Final Values)|2.4|Standard Error of the Mean|1.6||0.139||95.0|-0.8|5.5||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.|
1727382|NCT00581555|3182695|Superiority or Other||Mean Difference (Final Values)|135.2|Standard Error of the Mean|42.3||0.001|2-Sided|95.0|52.3|218.1||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.|
1727383|NCT00581555|3182696|Superiority or Other||Mean Difference (Final Values)|4.7|Standard Error of the Mean|1.3|<|0.001|2-Sided|95.0|2.1|7.3||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.|
1727384|NCT00581555|3182697|Superiority or Other|||||||0.0003|||||||Log Rank|Time to first relapse was estimated using the Kaplan-Meier’s, and comparisons between groups was performed using log rank tests.|||
1727385|NCT00581555|3182698|Superiority or Other|||||||0.002||||||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|Pearson chi-square|Treatment groups and visits were fixed factors with a logit link, a binomial distribution and an auto-regressive correlation structure.||Analysis from randomization to Week 24.|
1727386|NCT00581555|3182699|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.3||0.049|2-Sided|95.0|0.0|1.2||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis from randomization to Week 24.|
1727387|NCT00581555|3182700|Superiority or Other||Mean Difference (Final Values)|30.5|Standard Error of the Mean|8.0|<|0.001|2-Sided|95.0|14.8|46.3||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 24.|
1727388|NCT00581555|3182700|Superiority or Other||Mean Difference (Final Values)|16.1|Standard Error of the Mean|7.8|<|0.041|2-Sided|95.0|0.8|31.4||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was a covariate.||Analysis at randomization to Week 20.|
1727389|NCT00581555|3182700|Superiority or Other||Mean Difference (Final Values)|6.7|Standard Error of the Mean|7.6|<|0.381|2-Sided|95.0|-8.3|21.6||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 16.|
1727390|NCT00581555|3182700|Superiority or Other||Mean Difference (Final Values)|2.3|Standard Error of the Mean|7.6|<|0.758|2-Sided|95.0|-12.5|17.1||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 12.|
1727391|NCT00581555|3182700|Superiority or Other||Mean Difference (Final Values)|2.0|Standard Error of the Mean|7.5|<|0.795|2-Sided|95.0|-12.8|16.7||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 10.|
1727392|NCT00581555|3182700|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|7.5|<|0.999|2-Sided|95.0|-14.7|14.7||P-values were not adjusted for multiplicity and the priori threshold for statistical significance was 0.05.|mixed model of ANCOVA|Treatment groups and visits were fixed factors, participant was a random factor and baseline was covariate.||Analysis at randomization to Week 8.|
1727393|NCT00581386|3182710|Superiority or Other||Odds Ratio (OR)|7.22||||0.0004||95.0|2.419|21.527|||Regression, Logistic||||
1727394|NCT00581386|3182710|Superiority or Other||Odds Ratio (OR)|5.088||||0.003||95.0|1.728|14.99|||Regression, Logistic||||
1727395|NCT00581386|3182711|Superiority or Other||Odds Ratio (OR)|0.006||||0.006||95.0|||||t-test, 2 sided||||
1727397|NCT00581386|3182712|Superiority or Other||Odds Ratio (OR)|3.125||||0.013||95.0|1.27|7.67|||Regression, Logistic|Logistic regression Number of obs = 217, LR chi2(2)=10.89, Prob>chi2=0.0043,Log likelihood = -112.87788, Pseudo R2=0.0460|this is a simple odds ratio||
1727398|NCT00581256|3182729|Superiority or Other|||||||0.46|||||||Fisher Exact|||A PD increase of greater than 10% for a 1.5 SD threshold was considered significant.|
1727399|NCT00581256|3182729|Superiority or Other|||||||0.6|||||||Fisher Exact|||A Perfusion Defect (PD) increase of greater than 5% for a 2.5 SD threshold was considered significant.|
1727400|NCT00581230|3182730|Superiority or Other|||||||0.0001|||||||Wilcoxon signed rank test||||
1727401|NCT00581230|3182731|Superiority or Other|||||||0.0003|||||||Wilcoxon signed rank test||||
1727402|NCT00581100|3182734|Superiority or Other||||||<|0.0001||||||Adjusted change calculated from mixed-model. Model for change=[Group visit Group*visit baseline baseline*visit].|Mixed Models Analysis||||
1727403|NCT00581100|3182734|Superiority or Other||||||<|0.0001||||||Adjusted change calculated from mixed-model. Model for change=[Group visit Group*visit baseline baseline*visit].|Mixed Models Analysis||||
1727404|NCT00581100|3182735|Superiority or Other||||||<|0.0001||||||<Table 8-14> Change from baseline in Physician and Patient Assessment of Nail Psoriasis Activity Visual Analog Scale (VAS)|Mixed Models Analysis||||
1727405|NCT00581100|3182735|Superiority or Other||||||<|0.0001||||||Adjusted change calculated from mixed model. Model for change=[Group visit Group*visit baseline baseline*visit].|Mixed Models Analysis||||
1727406|NCT00581100|3182736|Superiority or Other||||||<|0.0001||||||Adjusted change calculated from mixed model. Model for change=[Group visit Group*visit baseline baseline*visit].|Mixed Models Analysis||||
1727407|NCT00581100|3182736|Superiority or Other||||||<|0.0001||||||Adjusted change calculated from mixed model. Model for change=[Group visit Group*visit baseline baseline*visit].|Mixed Models Analysis||||
1727408|NCT00581100|3182737|Superiority or Other||||||<|0.0001||||||Adjusted change calculated from mixed-model. Model for change=[Group visit Group*visit baseline baseline*visit].|Mixed Models Analysis||||
1727409|NCT00581100|3182737|Superiority or Other||||||<|0.0001||||||Adjusted change calculated from mixed-model. Model for change=[Group visit Group*visit baseline baseline*visit].|Mixed Models Analysis||||
1727410|NCT00581100|3182738|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model||||
1727411|NCT00581100|3182738|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model||||
1727412|NCT00581100|3182739|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model||||
1727413|NCT00581100|3182739|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model||||
1727414|NCT00581100|3182740|Superiority or Other||||||<|0.0001||||||Adjusted change calculated from mixed model. Model for change-[Group visit Group*visit baseline baseline*visit].|Mixed Models Analysis||||
1727415|NCT00581100|3182740|Superiority or Other||||||<|0.0001||||||Adjusted change calculated from mixed model. Model for change-[Group visit Group*visit baseline baseline*visit].|Mixed Models Analysis||||
1727416|NCT00581100|3182741|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 24|
1727417|NCT00581100|3182741|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 24|
1727418|NCT00581100|3182741|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 12|
1727419|NCT00581100|3182741|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 12|
1727420|NCT00581100|3182742|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 24|
1727421|NCT00581100|3182742|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 24|
1727422|NCT00581100|3182742|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 12|
1727423|NCT00581100|3182742|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 12|
1727424|NCT00581100|3182743|Superiority or Other||||||<|0.0001||||||Adjusted change calculated from mixed model. Model for change=[Group visit group*visit baseline baseline*visit].|Mixed Models Analysis||||
1727425|NCT00581100|3182743|Superiority or Other||||||<|0.0001||||||Adjusted change calculated from mixed model. Model for change=[Group visit group*visit baseline baseline*visit].|Mixed Models Analysis||||
1727426|NCT00581100|3182744|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 24|
1727506|NCT00578968|3182998|Superiority or Other|||||||0.009|||||||ANOVA||||
1727507|NCT00578968|3182999|Superiority or Other|||||||0.03|||||||ANOVA||||
1727427|NCT00581100|3182744|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 24|
1727428|NCT00581100|3182744|Superiority or Other||||||<|0.006||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 12|
1727429|NCT00581100|3182744|Superiority or Other||||||<|0.069||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 12|
1727430|NCT00581100|3182745|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =[Group visit Group*visit].|GEE model|||Week 24|
1727431|NCT00581100|3182745|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =[Group visit Group*visit].|GEE model|||Week 24|
1727432|NCT00581100|3182745|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =[Group visit Group*visit].|GEE model|||Week 12|
1727433|NCT00581100|3182745|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion =[Group visit Group*visit].|GEE model|||Week 12|
1727434|NCT00581100|3182746|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 24|
1727435|NCT00581100|3182746|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 24|
1727436|NCT00581100|3182746|Superiority or Other||||||<|0.006||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 12|
1727437|NCT00581100|3182746|Superiority or Other||||||<|0.007||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE) with treatment and visits as fixed factors. Model for proportion=[Group visit Group*visit].|GEE model|||Week 12|
1727438|NCT00581100|3182747|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = [Group visit Group*visit].|GEE model|||Week 24|
1727439|NCT00581100|3182747|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = [Group visit Group*visit].|GEE model|||Week 24|
1727440|NCT00581100|3182747|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = [Group visit Group*visit].|GEE model|||Week 12|
1727441|NCT00581100|3182747|Superiority or Other||||||<|0.001||||||P-value from generalized linear models for correlated data using Generalized Estimating Equations (GEE), with treatment and visits as fixed factors. Model for proportion = [Group visit Group*visit].|GEE model|||Week 12|
1727442|NCT00581100|3182748|Superiority or Other||||||<|0.0001||||||Adjusted change calculated from mixed-model. Model for change = [Group visit Group*visit baseline baseline*visit].|Mixed Models Analysis||||
1727443|NCT00581100|3182748|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Adjusted change calculated from mixed-model. Model for change = [Group visit Group*visit baseline baseline*visit].|||
1727444|NCT00581100|3182749|Superiority or Other||||||<|0.0001||||||Adjusted change calculated from mixed-model. Model for change = [Group visit Group*visit baseline baseline*visit].|Mixed Models Analysis||||
1727445|NCT00581100|3182749|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Adjusted change calculated from mixed-model. Model for change = [Group visit Group*visit baseline baseline*visit].|||
1727446|NCT00580970|3182759|Superiority or Other|||||||0.9138||||||Considering all late rectal toxicities, 38% (20/53) of participants developed physician reported Grade 2 or higher GI toxicity during 2 year follow up. The threshold for significance was p < 0.05.|t-test, 1 sided|A one sided t-test, with 5% level of significance, and 83% power was used which required 53 subjects.|||
1727447|NCT00580801|3182808|Superiority or Other||Least square mean ratio|1.24||||||90.0|0.88|1.74|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.||
1727448|NCT00580801|3182809|Superiority or Other||Least square mean ratio|1.43||||||90.0|1.02|2.02|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.||
1727449|NCT00580801|3182810|Superiority or Other||Least square mean ratio|1.32||||||90.0|1.05|1.66|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.||
1727450|NCT00580801|3182810|Superiority or Other||Least square mean ratio|1.0||||||90.0|0.58|1.72|||||Day 1: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.||
1727451|NCT00580801|3182811|Superiority or Other||Least square mean ratio|1.33||||||90.0|1.03|1.72|||||Day 15: The LS means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.||
1727452|NCT00580801|3182811|Superiority or Other||Least square mean ratio|0.98||||||90.0|0.54|1.78|||||Day 1: The least square (LS) means of the primary parameters for the test and the reference groups were estimated with a linear mixed effects model controlling for treatment group as fixed effects.||
1727453|NCT00580788|3182818|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.002||||||the reported p-value corresponds to the increase comapred to baseline over time (days 2-8) in the PTHrP 4 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727454|NCT00580788|3182819|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.05||||||the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727455|NCT00580788|3182820|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01||||||the reported p=value corresponds to % change compared to baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727456|NCT00580788|3182820|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.001||||||the reported p-value correspond to the decrease compared to baseline over time in the PTHrP 4 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727457|NCT00580788|3182821|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01||||||the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727458|NCT00580788|3182821|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001||||||the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727459|NCT00580788|3182822|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05||||||The reported p-value corresponds to the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727460|NCT00580788|3182822|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001||||||The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727461|NCT00580788|3182823|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05||||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727462|NCT00580788|3182823|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.008||||||The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727463|NCT00580788|3182824|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05||||||The reported p-value corresponds to change over time from baseline for all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727464|NCT00580788|3182825|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001||||||The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727465|NCT00580788|3182826|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001||||||The reported p-value corresponds to the increase over time for the PTHrP 4 pmol group.|Mixed Models Analysis|Value The level of statistical significance was set at .05 (two-tailed)|||
1727466|NCT00580788|3182827|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.61||||||The reported p-value corresponds to all Arms/Groups at all time points compared to baseline|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727508|NCT00578968|3183000|Superiority or Other|||||||0.85|||||||ANOVA||||
1727509|NCT00578968|3183001|Superiority or Other|||||||0.01|||||||ANOVA||||
1727510|NCT00578968|3183002|Superiority or Other|||||||0.15|||||||ANOVA||||
1727467|NCT00580788|3182829|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01||||||the reported p value corresponds to a decrease by Day 8 compared to baseline in the PTHrP 4 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727468|NCT00580788|3182829|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05||||||The reported p-value corresponds to change over time for the PTHrP 2 and PTHrP 5 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1727469|NCT00580606|3182849|Superiority or Other||Risk Difference (RD)|55.0|||<|0.001|2-Sided|95.0|22.2|77.6||No adjustments were made to the p-value.|Barnard's Statistic|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 5,000 mg of peanut powder or at least a 10-fold increase in the amount of peanut powder compared to their baseline OFC was compared using Barnard's Statistic with the null hypothesis that there was no difference between treatment groups.|
1727470|NCT00580047|3182872|Other||||||||||||||||||The intervention groups were compared for compliance to either having annual IV zoledronic acid, taking weekly oral alendronate, and taking calcium/vitamin D supplementation.
1727471|NCT00579982|3182892|Superiority or Other||||||<|0.001||||||Paired t-test|t-test, 2 sided||||
1727472|NCT00579826|3182895|Superiority or Other (legacy)|||||||0.73|||||||Wilcoxon (Mann-Whitney)||||
1727473|NCT00579826|3182896|Superiority or Other (legacy)|||||||0.96|||||||Wilcoxon (Mann-Whitney)||||
1727474|NCT00579826|3182897|Superiority or Other (legacy)|||||||0.92|||||||Wilcoxon (Mann-Whitney)||||
1727475|NCT00579436|3182958|Superiority|||||||0.5|||||||t-test, 2 sided||||
1727476|NCT00579436|3182959|Superiority|||||||0.5|||||||t-test, 2 sided||||
1727477|NCT00579436|3182960|Superiority|||||||0.05|||||||t-test, 2 sided||||
1727478|NCT00579436|3182961|Superiority|||||||0.05|||||||t-test, 2 sided||||
1727479|NCT00579345|3182962|Non-Inferiority or Equivalence|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.69|||||2-Sided|95.0|0.46|1.02|||||B (Day 22)|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.|
1727480|NCT00579345|3182962|Non-Inferiority or Equivalence|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.81|||||2-Sided|95.0|0.55|1.19|||||A/H3N2 (Day 22)-criterion was met|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.|
1727481|NCT00579345|3182962|Non-Inferiority or Equivalence|Non-inferiority was met if lower limit of the 2-sided 95% Clopper-Pearson confidence interval (CI) of the ratio of the postvaccination (Day 22) Geometric Mean Titers (FLU+PV/FLU vaccine alone) was greater than 0.5.|Ratio of GMTs|0.66|||||2-Sided|95.0|0.45|0.98|||||A/H1N1(Day22)|The non-inferiority null hypothesis stated that the FLU+PV vaccine group was non-inferior to the FLU alone group if the lower limit of the 95% CI of the ratio of GMTs between vaccines (FLU+PV/FLU alone) on day 22 was greater than 0.5 for all three vaccine strains.|
1727482|NCT00579098|3182975|Superiority or Other|||||||0.92||||||A p-value of < 0.05 was considered statistically significant.|t-test, 2 sided|||The change in HDL cholesterol was compared between treatment groups.|
1727483|NCT00579098|3182975|Superiority or Other||||||<|0.001||||||A p-value of < 0.05 was considered statistically significant.|t-test, 2 sided|||The change in LDL cholesterol was compared between treatment groups.|
1727484|NCT00579098|3182975|Superiority or Other||||||<|0.001||||||A p-value of < 0.05 was considered statistically significant.|t-test, 2 sided|||The change in total cholesterol was compared between treatment groups.|
1727485|NCT00579098|3182976|Superiority or Other|||||||0.53||||||Comparison between treatment groups. A p-value of < 0.05 was considered statistically significant.|t-test, 2 sided||||
1727486|NCT00579098|3182977|Superiority or Other|||||||0.11||||||A p-value of < 0.05 was considered statistically significant.|t-test, 2 sided||||
1727487|NCT00579098|3182978|Superiority or Other|||||||0.37||||||A p-value of < 0.05 was considered statistically significant.|Log Rank||||
1727488|NCT00579098|3182979|Superiority or Other|||||||0.75||||||A p-value of < 0.05 was considered statistically significant.|Log Rank||||
1727489|NCT00578968|3182982|Superiority or Other|||||||0.04|||||||ANOVA||||
1727490|NCT00578968|3182983|Superiority or Other|||||||0.16|||||||ANOVA||||
1727491|NCT00578968|3182984|Superiority or Other|||||||0.19|||||||ANOVA||||
1727492|NCT00578968|3182985|Superiority or Other|||||||0.04|||||||ANOVA||||
1727493|NCT00578968|3182986|Superiority or Other|||||||0.04|||||||ANOVA||||
1727494|NCT00578968|3182987|Superiority or Other|||||||0.09|||||||ANOVA||||
1727495|NCT00578968|3182988|Superiority or Other|||||||0.06|||||||ANOVA||||
1727496|NCT00578968|3182989|Superiority or Other|||||||0.22|||||||ANOVA||||
1727497|NCT00578968|3182990|Superiority or Other|||||||0.11|||||||ANOVA|||Comparison was made between groups at pretreatment peak exercise time period.|
1727498|NCT00578968|3182990|Superiority or Other|||||||0.73|||||||ANOVA|||Comparison was made between groups at pretreatment resting time period.|
1727499|NCT00578968|3182991|Superiority or Other|||||||0.43|||||||ANOVA||||
1727500|NCT00578968|3182992|Superiority or Other|||||||0.65|||||||ANOVA||||
1727501|NCT00578968|3182993|Superiority or Other|||||||0.35|||||||ANOVA||||
1727502|NCT00578968|3182994|Superiority or Other|||||||0.6|||||||ANOVA||||
1727503|NCT00578968|3182995|Superiority or Other|||||||0.003|||||||ANOVA||||
1727513|NCT00578968|3183005|Superiority or Other||||||<|0.01|||||||ANOVA|||Comparison was made between the two groups at baseline peak exercise|
1727514|NCT00578968|3183005|Superiority or Other||||||<|0.13|||||||ANOVA|||Comparison between the two groups at baseline resting.|
1727515|NCT00578968|3183006|Superiority or Other||||||<|0.001|||||||ANOVA||||
1727516|NCT00578968|3183007|Superiority or Other||||||<|0.001|||||||ANOVA||||
1727517|NCT00578968|3183008|Superiority or Other||||||<|0.001|||||||ANOVA||||
1727518|NCT00578968|3183009|Superiority or Other|||||||0.01|||||||ANOVA||||
1727519|NCT00578864|3183024|Superiority or Other (legacy)|||||||0.592|||||||Fisher Exact||||
1727520|NCT00578864|3183027|Superiority or Other (legacy)|||||||0.367|||||||Fisher Exact||||
1727521|NCT00578786|3183056|Superiority or Other||Mean Difference (Net)|-0.14|Standard Deviation|2.467|||2-Sided|95.0|-0.39|0.11|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727522|NCT00578786|3183056|Superiority or Other||Mean Difference (Net)|-0.48|Standard Deviation|2.215|||2-Sided|95.0|-0.93|-0.03|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727523|NCT00578786|3183056|Superiority or Other||Mean Difference (Net)|-0.14|Standard Deviation|2.514|||2-Sided|95.0|-0.51|0.22|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727524|NCT00578786|3183056|Superiority or Other||Mean Difference (Net)|0.2|Standard Deviation|2.593|||2-Sided|95.0|-0.33|0.74|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727525|NCT00578786|3183057|Superiority or Other||Mean Difference (Net)|-0.27|Standard Deviation|2.48|||2-Sided|95.0|-0.52|-0.02|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727526|NCT00578786|3183057|Superiority or Other||Mean Difference (Net)|-0.65|Standard Deviation|2.305|||2-Sided|95.0|-1.12|-0.18|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727527|NCT00578786|3183057|Superiority or Other||Mean Difference (Net)|-0.33|Standard Deviation|2.477|||2-Sided|95.0|-0.68|0.03|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727528|NCT00578786|3183057|Superiority or Other||Mean Difference (Net)|0.23|Standard Deviation|2.603|||2-Sided|95.0|-0.31|0.76|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727529|NCT00578786|3183058|Superiority or Other||Mean Difference (Final Values)|-0.44|Standard Deviation|2.393|||2-Sided|95.0|-0.69|-0.2|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727530|NCT00578786|3183058|Superiority or Other||Mean Difference (Net)|-0.51|Standard Deviation|2.4|||2-Sided|95.0|-1.0|-0.03|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727531|NCT00578786|3183058|Superiority or Other||Mean Difference (Net)|-0.59|Standard Deviation|2.45|||2-Sided|95.0|-0.94|-0.23|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727532|NCT00578786|3183058|Superiority or Other||Mean Difference (Net)|-0.08|Standard Deviation|2.254|||2-Sided|95.0|-0.55|0.38|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727533|NCT00578786|3183060|Superiority or Other||Mean Difference (Net)|16.6|Standard Deviation|96.54|||2-Sided|95.0|6.8|26.4|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727534|NCT00578786|3183060|Superiority or Other||Mean Difference (Net)|27.8|Standard Deviation|87.07|||2-Sided|95.0|10.1|45.4|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727535|NCT00578786|3183060|Superiority or Other||Mean Difference (Net)|18.8|Standard Deviation|101.22|||2-Sided|95.0|4.2|33.5|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727536|NCT00578786|3183060|Superiority or Other||Mean Difference (Net)|0.7|Standard Deviation|95.21|||2-Sided|95.0|-18.9|20.3|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727537|NCT00578786|3183061|Superiority or Other||Median Difference (Net)|20.3|Standard Deviation|96.05|||2-Sided|95.0|10.6|30.1|||||Applies to Ambrisentan combined group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727538|NCT00578786|3183061|Superiority or Other||Mean Difference (Net)|28.0|Standard Deviation|84.38|||2-Sided|95.0|10.9|45.1|||||Applies to Ambrisentan 10 mg group only. LOCF method of imputation.||
1727539|NCT00578786|3183061|Superiority or Other||Mean Difference (Net)|23.2|Standard Deviation|100.69|||2-Sided|95.0|8.7|37.8|||||Applies to Ambrisentan 5 mg group only. LOCF method of imputation.||
1727540|NCT00578786|3183061|Superiority or Other||Mean Difference (Net)|6.7|Standard Deviation|97.48|||2-Sided|95.0|-13.4|26.8|||||Applies to Ambrisentan 2.5 mg group only. LOCF method of imputation.||
1727541|NCT00578786|3183062|Superiority or Other||Median Difference (Net)|29.5|Standard Deviation|89.81|||2-Sided|95.0|20.4|38.7|||||Applies to Ambrisentan combined group only. LOCF method of imputation.||
1727542|NCT00578786|3183062|Superiority or Other||Mean Difference (Net)|37.2|Standard Deviation|72.97|||2-Sided|95.0|22.4|52.0|||||Applies to Ambrisentan 10 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727604|NCT00577655|3183270|Superiority or Other|||||||0.0013||||||significance level of 0.05.|Fisher Exact|||Day 1|
1727543|NCT00578786|3183062|Superiority or Other||Mean Difference (Net)|27.9|Standard Deviation|94.5|||2-Sided|95.0|14.2|41.6|||||Applies to Ambrisentan 5.0 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727544|NCT00578786|3183062|Superiority or Other||Mean Difference (Net)|24.9|Standard Deviation|96.14|||2-Sided|95.0|5.1|44.7|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727545|NCT00578786|3183063|Superiority or Other||Mean Difference (Net)|36.0|Standard Deviation|75.97|||2-Sided|95.0|28.3|43.7|||||Applies to Ambrisentan combined group only. LOCF method of imputation.||
1727546|NCT00578786|3183063|Superiority or Other||Mean Difference (Net)|40.9|Standard Deviation|72.85|||2-Sided|95.0|26.1|55.7|||||Applies to Ambrisentan 10 mg group only. LOCF method of imputation. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727547|NCT00578786|3183063|Superiority or Other||Mean Difference (Net)|32.5|Standard Deviation|78.55|||2-Sided|95.0|21.1|43.8|||||Applies to Ambrisentan 5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727548|NCT00578786|3183063|Superiority or Other||Mean Difference (Net)|38.0|Standard Deviation|74.28|||2-Sided|95.0|22.7|53.3|||||Applies to Ambrisentan 2.5 mg group only. Missing values were imputed using last-observation-carried forward method (LOCF) based on post-baseline observations.||
1727549|NCT00578552|3183081|Superiority or Other|||||||1|||||||Fisher Exact|1-tailed||Data were compared between treatment groups using Fisher’s exact test for binary outcomes.|
1727550|NCT00578552|3183081|Superiority or Other|||||||0.77|||||||Fisher Exact|1-tailed||Data were compared between treatment groups using Fisher’s exact test for binary outcomes.|
1727551|NCT00578383|3183095|Superiority or Other||Mean Difference (Net)|2.2|Standard Error of the Mean|1.43||0.1||95.0|-1.3|5.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (negative scale)|
1727552|NCT00578383|3183096|Superiority or Other||Mean Difference (Net)|1.3|Standard Error of the Mean|2.01||0.52|2-Sided|95.0|-4.1|6.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (negative scale)|
1727553|NCT00578383|3183097|Superiority or Other||Mean Difference (Net)|1.7|Standard Error of the Mean|1.58||0.3|2-Sided|95.0|1.3|5.8||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the PANAS (positive scale)|
1727554|NCT00578383|3183098|Superiority or Other||Mean Difference (Net)|5.0|Standard Error of the Mean|1.67||0.004|2-Sided|95.0|0.8|9.2||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the PANAS (positive scale)|
1727555|NCT00578383|3183099|Superiority or Other||Mean Difference (Net)|1.58|Standard Error of the Mean|0.67||0.04|2-Sided|95.0|-0.4|3.6||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by a visual analog scale.|
1727556|NCT00578383|3183100|Superiority or Other||Mean Difference (Net)|0.76|Standard Error of the Mean|0.51||0.15|2-Sided|95.0|-0.6|2.1||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by a visual analog scale.|
1727557|NCT00578383|3183101|Superiority or Other||Mean Difference (Net)|3.2|Standard Error of the Mean|2.11||0.19|2-Sided|95.0|-3.3|9.6||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.|
1727583|NCT00577720|3183260|Superiority or Other||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|0.947|||||2-Sided|90.0|0.316|2.993||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).|
1727605|NCT00577655|3183271|Superiority or Other|||||||0.0845||||||significance level of 0.05.|Fisher Exact|||Day 22|
1727558|NCT00578383|3183102|Superiority or Other||Mean Difference (Net)|2.5|Standard Error of the Mean|1.47||0.09|2-Sided|95.0|-1.2|6.2||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.0125 for significance (correction factor 4)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression as assessed by the 17-item Hamilton Depression Rating Scale.|
1727559|NCT00578383|3183103|Superiority or Other||Mean Difference (Net)|2.0|Standard Error of the Mean|1.39||0.15|2-Sided|95.0|-1.1|5.1||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (negative scale)|
1727560|NCT00578383|3183104|Superiority or Other||Mean Difference (Net)|4.1|Standard Error of the Mean|1.24||0.001|2-Sided|95.0|1.3|6.9||we used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the PANAS (POSITIVE SCALE).|
1727561|NCT00578383|3183105|Superiority or Other||Mean Difference (Net)|1.06|Standard Error of the Mean|0.38||0.006|2-Sided|95.0|0.2|1.9||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2)|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by a visual analog scale.|
1727562|NCT00578383|3183106|Superiority or Other||Mean Difference (Net)|3.11|Standard Error of the Mean|1.17||0.009|2-Sided|95.0|0.5|5.8||We used type HC3 robust standard errors (SEs)in place of OLS regression SEs to guard against biased estimation of SEs due to heteroscedasticity. This is an uncorrected p-value with a required threshold of 0.025 for significance (correction factor 2).|Regression, Linear|Bonferroni multiple testing corrections were applied separately to results for our primary and secondary outcomes.||Active LFMS treatment would reduce depression immediately after treatment in subjects with bipolar depression and those with major depressive disorder as assessed by the 17-item Hamilton Depression Rating Scale.|
1727563|NCT00578136|3183197|Superiority or Other|||||||0.008|||||||Wilcoxon (Mann-Whitney)|The Wilcoxon rank-sum test was used because the study did not have a normal distribution using the Kolmogorov-Smirnov test (p<0.01).||Assuming the opioid requirement in the local infiltration group to be 0.2mg kg-1 and in the rectus sheath block group to be 0.1mg kg-1, a sample size of 44 patients (22 in each group) will have a power of 80% to detect a difference in means of 0.1mg kg-1 with a 0.005 two-sided significance level.|
1727564|NCT00577824|3183242|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1727565|NCT00577824|3183243|Superiority or Other|||||||0.2|||||||t-test, 2 sided||||
1727566|NCT00577824|3183245|Superiority or Other|||||||0.974|||||||t-test, 2 sided||||
1727567|NCT00577824|3183246|Superiority or Other|||||||0.708|||||||t-test, 2 sided||||
1727568|NCT00577824|3183248|Superiority or Other|||||||0.208|||||||t-test, 2 sided||||
1727569|NCT00577824|3183249|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1727570|NCT00577824|3183250|Superiority or Other|||||||0.49|||||||t-test, 2 sided||||
1727571|NCT00577824|3183251|Superiority or Other|||||||0.014|||||||t-test, 2 sided||||
1727572|NCT00577824|3183252|Superiority or Other|||||||0.58|||||||t-test, 2 sided||||
1727573|NCT00577824|3183253|Superiority or Other|||||||0.672|||||||t-test, 2 sided||||
1727574|NCT00577824|3183254|Superiority or Other|||||||0.026||||||No adjustment for multiplicity. Significance level was 5% (two-sided).|ANCOVA||||
1727575|NCT00577824|3183255|Superiority or Other||||||<|0.002||||||No adjustment for multiplicity. Significance level was 5% (two-sided).|ANCOVA||||
1727576|NCT00577824|3183256|Superiority or Other||||||<|0.001|||||||Cochran-Armitage||||
1727577|NCT00577824|3183257|Superiority or Other||||||<|0.001|||||||Cochran-Armitage||||
1727578|NCT00577824|3183258|Superiority or Other||||||<|0.001||||||Bonferroni's method was used to adjustment for multiplicity, and significant level was set to 2.5%(two-sided).|ANCOVA|ANCOVA model with treatment group as a factor and baseline value as the covariate.|||
1727579|NCT00577720|3183260|Superiority or Other||Ratio (LS Mean 50 mg DRFB/50 mgDRBB)|0.868|||||2-Sided|90.0|0.504|1.488||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).|
1727580|NCT00577720|3183260|Superiority or Other||Ratio (LS Mean 50 mg DRFB/35 mg DRFB)|1.668|||||2-Sided|90.0|0.856|4.668||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).|
1727581|NCT00577720|3183260|Superiority or Other||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.58|||||2-Sided|90.0|0.801|4.718||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).|
1727582|NCT00577720|3183260|Superiority or Other||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.82|||||2-Sided|90.0|0.929|5.429||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).|
1727584|NCT00577720|3183261|Superiority or Other||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.243|||||2-Sided|90.0|0.828|1.99||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).|
1727585|NCT00577720|3183261|Superiority or Other||Ratio (LS Mean 50 mg DRFB/35 mg DRFB)|1.165|||||2-Sided|90.0|0.797|1.752||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).|
1727586|NCT00577720|3183261|Superiority or Other||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.407|||||2-Sided|90.0|0.913|2.404||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).|
1727587|NCT00577720|3183261|Superiority or Other||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.132|||||2-Sided|90.0|0.665|2.003||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).|
1727588|NCT00577720|3183261|Superiority or Other||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|1.208|||||2-Sided|90.0|0.749|2.099||||||The target numbers of subjects assessable for the primary analysis are 70 in the 50 mg DRFB group and 35 in the 35 mg IRBB group. Sample sizes are determined to provide adequate power for the primary comparison (ie, serum CTX for 50 mg DRFB vs. 35 mg IRBB).|
1727589|NCT00577720|3183262|Superiority or Other||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.018|||||2-Sided|90.0|0.824|1.267||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.|
1727590|NCT00577720|3183262|Superiority or Other||Ratio (LS Mean 50 mg DRFB/50 mg DRBB)|1.068|||||2-Sided|90.0|0.867|1.321||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.|
1727591|NCT00577720|3183262|Superiority or Other||Ratio (LS Mean 50 mg DRFB/35 mg IRBB)|1.535|||||2-Sided|90.0|1.177|2.086||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.|
1727592|NCT00577720|3183262|Superiority or Other||Ratio (LS Mean 50 mg DRBB/35 mg IRBB)|1.507|||||2-Sided|90.0|1.139|2.066||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.|
1727593|NCT00577720|3183262|Superiority or Other||Ratio (LS Mean 35 mg DRFB/35 mg IRBB)|1.437|||||2-Sided|90.0|1.091|1.964||||||For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.|
1727594|NCT00577655|3183266|Superiority or Other||ratio of Active to Placebo|0.887||||0.8326|2-Sided|95.0|-0.111|1.885||significance level of 0.05.|mixed poisson regression model|||"Week 3~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."|
1727595|NCT00577655|3183266|Superiority or Other||ratio of Active to Placebo|0.961||||0.9447|2-Sided|95.0|-0.116|2.039||significance level of 0.05.|mixed poisson regression model|||"Week 2~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."|
1727596|NCT00577655|3183266|Superiority or Other||ratio of Active to Placebo|0.989||||0.9846|2-Sided|95.0|-0.121|2.099||significance level of 0.05.|mixed poisson regression model|||"Week 1~P-value, mean and confidence interval calculated from a 0 inflated mixed poisson regression model with fixed effect terms for treatment, week, treatment by week interaction, baseline as a covariate and a random term for subject. The null hypothesis is that the ratio equals 1. Estimated means are conditional upon the random effect, assume a random effect of 0 and a covariate value at the average."|
1727597|NCT00577655|3183267|Superiority or Other||Mean Difference (Final Values)|9.546||||0.157|2-Sided|95.0|-3.705|22.798||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 3|
1727598|NCT00577655|3183267|Superiority or Other||Mean Difference (Final Values)|10.923||||0.1043|2-Sided|95.0|-2.278|24.124||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 2|
1727599|NCT00577655|3183267|Superiority or Other||Mean Difference (Final Values)|9.926||||0.1391|2-Sided|95.0|-3.256|23.108||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 1|
1727600|NCT00577655|3183269|Superiority or Other||Mean Difference (Final Values)|-0.138||||0.1699|2-Sided|95.0|-0.335|0.059||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as covariate, subject as random|Active - Placebo|Week 3|
1727601|NCT00577655|3183269|Superiority or Other||Mean Difference (Final Values)|-0.171||||0.084|2-Sided|95.0|-0.365|0.023||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as covariate, subject as random|Active - Placebo|Week 2|
1727602|NCT00577655|3183269|Superiority or Other||Mean Difference (Final Values)|-0.072||||0.4674|2-Sided|95.0|-0.265|0.122||significance level of 0.05.|ANCOVA|terms for treatment, center, week, week by treatment, baseline as a covariate, subject as random.|Active - Placebo|Week 1|
1727603|NCT00577655|3183270|Superiority or Other|||||||0.0085||||||significance level of 0.05.|Fisher Exact|||Day 22|
1727606|NCT00577655|3183271|Superiority or Other|||||||0.0109||||||significance level of 0.05.|Fisher Exact|||Day 1|
1727607|NCT00577655|3183272|Superiority or Other|||||||0.0962||||||significance level of 0.05.|Fisher Exact|||Day 22|
1727608|NCT00577655|3183272|Superiority or Other|||||||0.0343||||||significance level of 0.05.|Fisher Exact|||Day 1|
1727609|NCT00577655|3183273|Superiority or Other|||||||0.1249||||||significance level of 0.05.|Fisher Exact|||Day 22|
1727610|NCT00577655|3183273|Superiority or Other|||||||0.3888||||||significance level of 0.05.|Fisher Exact|||Day 1|
1727611|NCT00577655|3183274|Superiority or Other||Cox Proportional Hazard|1.533||||0.0333|2-Sided|95.0|1.03|2.27||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 22|
1727612|NCT00577655|3183274|Superiority or Other||Cox Proportional Hazard|1.141||||0.5059|2-Sided|95.0|0.77|1.69||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 1|
1727613|NCT00577655|3183275|Superiority or Other||Cox Proportional Hazard|2.088||||0.0005|2-Sided|95.0|1.38|3.15||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 22|
1727614|NCT00577655|3183275|Superiority or Other||Cox Proportional Hazard|1.477||||0.0647|2-Sided|95.0|0.98|2.23||significance level of 0.05.|Regression, Cox||Active/Placebo|Day 1|
1727615|NCT00577655|3183276|Superiority or Other||Mean Difference (Final Values)|3.998||||0.0521|2-Sided|95.0|-0.037|8.032||significance level of 0.05.|ANOVA|terms for treatment, center, time, time x treatment, subject as a random|Active - Placebo|Day 22|
1727616|NCT00577655|3183276|Superiority or Other||Mean Difference (Final Values)|6.524||||0.0017|2-Sided|95.0|2.524|10.523||significance level of 0.05.|ANOVA|terms for treatment, center, time, time x treatment, subject as a random|Active - Placebo|Day 1|
1727617|NCT00577655|3183277|Superiority or Other||Mean Difference (Final Values)|42.578||||0.2375|2-Sided|95.0|-28.541|113.7||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 1 Baseline|
1727618|NCT00577655|3183277|Superiority or Other||Mean Difference (Final Values)|30.124||||0.2186|2-Sided|95.0|-18.169|78.417||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 22 Baseline|
1727619|NCT00577655|3183278|Superiority or Other||Mean Difference (Final Values)|0.892||||0.924|2-Sided|95.0|-17.634|19.419||significance level of 0.05.|ANOVA|terms for treatment and center|Active - Placebo|Day 1 Baseline|
1727620|NCT00577655|3183278|Superiority or Other||Mean Difference (Final Values)|9.707||||0.0507|2-Sided|95.0|-0.03|19.445||significance level of 0.05.|ANCOVA|terms for treatment and center, baseline as a covariate|Active - Placebo|Day 22 Baseline|
1727621|NCT00577655|3183279|Superiority or Other||Mean Difference (Final Values)|3.782||||0.1843|2-Sided|95.0|-1.832|9.397||significance level of 0.05.|repeated measures ANOVA||Active - Placebo|"Day 22~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to PEFmax%0-2 at Days 1 and 22, with observed case data."|
1727622|NCT00577655|3183279|Superiority or Other||Mean Difference (Final Values)|7.572||||0.0074|2-Sided|95.0|2.077|13.067||significance level of 0.05.|repeated measures ANOVA||Active - Placebo|"Day 1~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to PEFmax%0-2 at Days 1 and 22, with observed case data."|
1727623|NCT00577655|3183280|Superiority or Other||Mean Difference (Final Values)|3.067||||0.047|2-Sided|95.0|0.041|6.094||significance level of 0.05.|Mixed Models Analysis||Active - Placebo|"Day 22~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to FEV1max%0-2 at Days 1 and 22, with observed case data."|
1727624|NCT00577655|3183280|Superiority or Other||Mean Difference (Final Values)|4.536||||0.0031|2-Sided|95.0|1.567|7.505||significance level of 0.05.|Mixed Models Analysis||Active - Placebo|"Day 1~A repeated measures mixed model, with terms for treatment, pooled center, study day, treatment by study day interaction, and baseline as a covariate, and subject as a random term, was used to make comparisons between placebo and active with respect to FEV1max%0-2 at Days 1 and 22, with observed case data."|
1727625|NCT00577655|3183281|Superiority or Other||Mean Difference (Final Values)|5.431||||0.0403|2-Sided|95.0|0.244|10.618||In order to control the overall alpha level at the 0.05 value, each of the primary endpoints were tested separately at the 0.025 level of significance.|ANCOVA|Baseline as covariate and fixed effects of treatment and pooled investigator site.|Active - Placebo|Efficacy was declared if the test for either primary efficacy endpoint was significant at the 0.025 level.|
1727626|NCT00577655|3183282|Superiority or Other||Mean Difference (Final Values)|3.496||||0.0138|2-Sided|95.0|0.729|6.262||In order to control the overall alpha level at the 0.05 value, each of the primary endpoints were tested separately at the 0.025 level of significance.|ANCOVA|Baseline as covariate and fixed effects of treatment and pooled investigator site.|Active - Placebo|Efficacy was declared if the test for either primary efficacy endpoint was significant at the 0.025 level.|
1727627|NCT00577642|3183283|Other|single group|||||<|0.05|||||||t-test, 1 sided|||Paired t-tests were used to compare differences of NTX cytokine levels at study entry versus end-of-study.|
1727628|NCT00577473|3183291|Superiority or Other||Risk Difference (RD)|0.065||||0.2583|2-Sided|95.0|-4.72|17.73|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.|
1727629|NCT00577473|3183292|Superiority or Other||Risk Difference (RD)|0.0051||||0.9349|2-Sided|95.0|-11.67|12.69|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.|
1727679|NCT00576758|3183446|Superiority or Other||Mean Difference (Final Values)|2.22|||||2-Sided|95.0|-13.9|18.3|||||||
1727630|NCT00577473|3183293|Superiority or Other||Risk Difference (RD)|0.0652||||0.2931|2-Sided|95.0|-5.6|18.64|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.|
1727631|NCT00577473|3183294|Superiority or Other||Risk Difference (RD)|0.0738||||0.2306|2-Sided|95.0|-4.66|19.43|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.|
1727632|NCT00577473|3183295|Superiority or Other||Risk Difference (RD)|0.1139||||0.0551|2-Sided|95.0|-0.13|22.92|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.|
1727633|NCT00577473|3183296|Superiority or Other||Risk Difference (RD)|0.1091||||0.0769|2-Sided|95.0|-1.1|22.91|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.|
1727634|NCT00577473|3183297|Superiority or Other||Risk Difference (RD)|0.0351||||0.5569|2-Sided|95.0|-8.18|15.2|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.|
1727635|NCT00577473|3183298|Superiority or Other||Risk Difference (RD)|0.0766||||0.215|2-Sided|95.0|-4.41|19.74|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.|
1727636|NCT00577473|3183299|Superiority or Other||Risk Difference (RD)|0.0339||||0.5761|2-Sided|95.0|-8.48|15.26|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.|
1727637|NCT00577473|3183300|Superiority or Other||Risk Difference (RD)|-0.0445||||0.473|2-Sided|95.0|-16.6|7.7|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.|
1727638|NCT00577473|3183301|Superiority or Other||Risk Difference (RD)|-0.0331||||0.5677|2-Sided|95.0|-14.67|8.04|||Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.|
1727639|NCT00577473|3183302|Superiority or Other||Risk Difference (RD)|0.0455||||0.4411|2-Sided|95.0|-7.01|16.11||4.8 g/day compared to 2.4 g/day|Chi-squared|||It was assumed that the true rate of improvement for the 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.|
1727640|NCT00577460|3183317|Superiority or Other|||||||0.0201|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727641|NCT00577460|3183317|Superiority or Other|||||||0.0148|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727642|NCT00577460|3183318|Superiority or Other|||||||0.5113|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727643|NCT00577460|3183318|Superiority or Other|||||||0.876|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727644|NCT00577460|3183319|Superiority or Other|||||||0.0002|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727645|NCT00577460|3183319|Superiority or Other|||||||0.0015|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727646|NCT00577460|3183320|Superiority or Other|||||||0.013|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727647|NCT00577460|3183320|Superiority or Other|||||||0.1713|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727648|NCT00577460|3183321|Superiority or Other|||||||0.0759|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727649|NCT00577460|3183321|Superiority or Other|||||||0.0831|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727650|NCT00577460|3183325|Superiority or Other|||||||0.762|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727651|NCT00577460|3183325|Superiority or Other|||||||0.9741|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727652|NCT00577460|3183326|Superiority or Other|||||||0.2469|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727653|NCT00577460|3183326|Superiority or Other|||||||0.6434|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727654|NCT00577460|3183327|Superiority or Other|||||||0.0573|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727655|NCT00577460|3183327|Superiority or Other|||||||0.0009|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727656|NCT00577460|3183328|Superiority or Other|||||||0.8694|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727657|NCT00577460|3183328|Superiority or Other|||||||0.1073|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727658|NCT00577460|3183330|Superiority or Other|||||||0.1289|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727659|NCT00577460|3183330|Superiority or Other|||||||0.559|||||||ANCOVA|Analysis of covariance with factors for treatment, country and baseline as a covariate|||
1727660|NCT00577460|3183333|Superiority or Other|||||||0.0001|||||||ANCOVA|Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline||PPX IR versus Placebo|
1727661|NCT00577460|3183333|Superiority or Other|||||||0.0039|||||||ANCOVA|Analysis of covariance (ANCOVA) with factors treatment and country and covariate OL baseline||PPX ER versus Placebo|
1727662|NCT00577096|3183376|Non-Inferiority or Equivalence|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|||The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.|
1727663|NCT00577096|3183377|Non-Inferiority or Equivalence|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.|
1727664|NCT00577096|3183378|Non-Inferiority or Equivalence|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.|
1727665|NCT00577096|3183379|Non-Inferiority or Equivalence|ANOVA|||||<|0.025||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of stem cell collection attempts.|
1727666|NCT00577096|3183380|Non-Inferiority or Equivalence|ANOVA|||||<|0.025||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.|||
1727667|NCT00577096|3183381|Non-Inferiority or Equivalence|T-test and chi-squared to check for equivalence of groups for age, race and gender.|||||<|0.025||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.|
1727668|NCT00577096|3183382|Non-Inferiority or Equivalence|T-test and chi-squared test to check for equivalence of groups for age, race and gender.|||||<|0.025||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|Analysis included short and long term participants.|||
1727669|NCT00577096|3183383|Non-Inferiority or Equivalence|ANOVA|||||<|0.025||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis is that there was no difference in the number of RBC tranfusions in the exercise versus usual care groups. Data was combined from the short and long term RBC transfusions.|
1727670|NCT00577096|3183384|Non-Inferiority or Equivalence|ANOVA|||||<|0.025||||||Bonferroni adjusted p-value for multiple comparisons.|ANOVA|This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.||The null hypothesis was that there would be no difference between groups for the number of RBC transfusions.|
1727671|NCT00577031|3183387|Superiority or Other|||||||0.0076|||||||Signed-rank test|||Change from baseline to last visit|
1727672|NCT00577005|3183403|Superiority or Other||Slope|-0.1557||||0.11|2-Sided|||||Significant p-value < 0.05|Mixed Models Analysis||Interaction of time x group: Z = -1.5671, p = 0.11708||
1727673|NCT00577005|3183404|Superiority or Other|||||||0.67||||||p-value <0.05 considered statistically significant|Log Rank|Chi-Square 0.175. df = 1, p=0.676|||
1727674|NCT00577005|3183405|Superiority or Other||Slope|0.0257|Standard Error of the Mean|0.04369||0.55|2-Sided|||||p-value <0.05 considered statistically significant|Mixed Models Analysis|We modeled the the change in thrice weekly opioid urines using a mixed-effect ordinal regression approach with MIXOR.|Group x time interaction: Z= 0.58823 p = 0.55638||
1727675|NCT00577005|3183406|Superiority or Other||Slope|-0.05425|Standard Error of the Mean|0.03211||0.09|2-Sided|||||p-value <0.05 considered statistically significant|Mixed Models Analysis|We modeled the the change in thrice weekly cocaine urines using a mixed-effect ordinal regression approach with MIXOR.|Group x time interaction: Z=-1.68950 p = 0.09112||
1727676|NCT00576927|3183409|Superiority or Other||Odds Ratio (OR)|1.46||||0.655|2-Sided|95.0|0.156|8.717||p-value suspect because of sparse cell counts|Chi-squared||||
1727677|NCT00576758|3183443|Superiority or Other||Hazard Ratio (HR)|1.0|||||2-Sided|95.0|0.67|1.5|||||||
1727678|NCT00576758|3183445|Superiority or Other||Hazard Ratio (HR)|0.93|||||2-Sided|95.0|0.62|1.44|||||||
1727723|NCT00576472|3183502|Superiority or Other|||||||0.0001|||||||t-test, 2 sided||||
1727680|NCT00576758|3183450|Superiority or Other||Mean Difference (Final Values)|6.83|||||2-Sided|95.0|-2.9|16.6|||||||
1727681|NCT00576758|3183451|Superiority or Other||Mean Difference (Final Values)|11.26||||0.1587|2-Sided|60.0|3.9|18.7|||Chi-squared||||
1727682|NCT00576732|3183456|Superiority or Other|||||||0.985||||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.|||
1727683|NCT00576732|3183456|Superiority or Other||||||<|0.001||||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.|||
1727684|NCT00576732|3183457|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.17||0.769|2-Sided|95.0|-0.39|0.29||P-value is not adjusted for multiple comparisons.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value|Mean difference is change in Risperidone low dose arm minus change in placebo arm.||
1727685|NCT00576732|3183457|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.17|<|0.001|2-Sided|95.0|-1.02|-0.33||P-value is not adjusted for multiple comparisons.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline CGI-S value.|Mean difference is change in Risperidone high dose arm minus change in placebo arm.||
1727686|NCT00576732|3183458|Superiority or Other|||||||0.817||||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.|||
1727687|NCT00576732|3183458|Superiority or Other|||||||0.004||||||P-value is not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test controlling for center (after pooling small centers) and baseline weight stratification.|||
1727688|NCT00576732|3183459|Superiority or Other||Mean Difference (Final Values)|-3.0|Standard Error of the Mean|2.17||0.164|2-Sided|95.0|-7.36|1.27||Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value|Mean difference is change in Risperidone low dose arm minus change in placebo arm.||
1727689|NCT00576732|3183459|Superiority or Other||Mean Difference (Final Values)|-7.9|Standard Error of the Mean|2.18|<|0.001|2-Sided|95.0|-12.19|-3.52||Type I error is preserved by the step down procedure, no multiple comparison adjustment is needed. A priori threshold for statistical significance was 0.05.|ANCOVA|ANCOVA model included factors for treatment group, center (after pooling of small centers), baseline weight stratification, and baseline ABC-I value|Mean difference is change in Risperidone high dose arm minus change in placebo arm.|"A step-down testing procedure was employed with the risperidone high dose versus placebo comparison tested first. If this comparison was significant the risperidone low dose versus placebo comparison would be performed.~A clinically relevant difference in the change from baseline on the ABC Irritability subscale was assumed to be 6 with a standard deviation of 8. To achieve 80% power with Type I error rate of 5%, 93 subjects were required."|
1727690|NCT00576693|3183460|Superiority or Other|||||||0.0252|||||||Log Rank|||The statistical analysis was based on a comparison of the of the two treatment groups with respect to the time to a primary outcome using the logrank test.|
1727691|NCT00576472|3183484|Superiority or Other|||||||0.1049|||||||t-test, 2 sided||||
1727692|NCT00576472|3183485|Superiority or Other|||||||0.0251|||||||t-test, 2 sided||||
1727693|NCT00576472|3183486|Superiority or Other|||||||0.5754|||||||t-test, 2 sided||||
1727694|NCT00576472|3183487|Superiority or Other|||||||0.4203|||||||t-test, 2 sided||||
1727695|NCT00576472|3183488|Superiority or Other|||||||0.4427|||||||t-test, 2 sided||||
1727696|NCT00576472|3183489|Superiority or Other|||||||0.8918|||||||t-test, 2 sided||||
1727697|NCT00576472|3183490|Superiority or Other|||||||0.5866|||||||t-test, 2 sided||||
1727698|NCT00576472|3183491|Superiority or Other|||||||0.4456|||||||t-test, 2 sided||||
1727699|NCT00576472|3183492|Superiority or Other|||||||0.6148|||||||t-test, 2 sided||||
1727700|NCT00576472|3183493|Superiority or Other|||||||0.7339|||||||t-test, 2 sided||||
1727701|NCT00576472|3183494|Superiority or Other|||||||0.7493|||||||t-test, 2 sided||||
1727702|NCT00576472|3183495|Superiority or Other|||||||0.7027|||||||t-test, 2 sided||||
1727703|NCT00576472|3183496|Superiority or Other|||||||0.2831|||||||t-test, 2 sided||||
1727704|NCT00576472|3183496|Superiority or Other|||||||0.0103|||||||t-test, 2 sided||||
1727705|NCT00576472|3183496|Superiority or Other|||||||0.1202|||||||t-test, 2 sided||||
1727706|NCT00576472|3183497|Superiority or Other|||||||0.1622|||||||t-test, 2 sided||||
1727707|NCT00576472|3183497|Superiority or Other|||||||0.0003|||||||t-test, 2 sided||||
1727708|NCT00576472|3183497|Superiority or Other|||||||0.019|||||||t-test, 2 sided||||
1727709|NCT00576472|3183498|Superiority or Other|||||||0.7021|||||||t-test, 2 sided||||
1727710|NCT00576472|3183498|Superiority or Other|||||||0.9489|||||||t-test, 2 sided||||
1727711|NCT00576472|3183498|Superiority or Other|||||||0.7496|||||||t-test, 2 sided||||
1727712|NCT00576472|3183499|Superiority or Other|||||||0.8039|||||||t-test, 2 sided||||
1727713|NCT00576472|3183499|Superiority or Other|||||||0.0905|||||||t-test, 2 sided||||
1727714|NCT00576472|3183499|Superiority or Other|||||||0.1386|||||||t-test, 2 sided||||
1727715|NCT00576472|3183500|Superiority or Other|||||||0.6071|||||||t-test, 2 sided||||
1727716|NCT00576472|3183500|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1727717|NCT00576472|3183500|Superiority or Other||||||<|0.0002|||||||t-test, 2 sided||||
1727718|NCT00576472|3183501|Superiority or Other|||||||0.6237|||||||t-test, 2 sided||||
1727719|NCT00576472|3183501|Superiority or Other|||||||0.0016|||||||t-test, 2 sided||||
1727720|NCT00576472|3183501|Superiority or Other|||||||0.0002|||||||t-test, 2 sided||||
1727721|NCT00576472|3183502|Superiority or Other|||||||0.7007|||||||t-test, 2 sided||||
1727722|NCT00576472|3183502|Superiority or Other|||||||0.0007|||||||t-test, 2 sided||||
1727726|NCT00576472|3183503|Superiority or Other|||||||0.0035|||||||t-test, 2 sided||||
1727727|NCT00576472|3183504|Superiority or Other|||||||0.4258|||||||t-test, 2 sided||||
1727728|NCT00576472|3183504|Superiority or Other|||||||0.0058|||||||t-test, 2 sided||||
1727729|NCT00576472|3183504|Superiority or Other|||||||0.0428|||||||t-test, 2 sided||||
1727730|NCT00576472|3183505|Superiority or Other|||||||0.1408|||||||t-test, 2 sided||||
1727731|NCT00576472|3183505|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1727732|NCT00576472|3183505|Superiority or Other||||||<|0.0077|||||||t-test, 2 sided||||
1727733|NCT00576472|3183507|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|1.04||0.8329|2-Sided|95.0|-1.9|2.3|||ANOVA||||
1727734|NCT00576472|3183508|Superiority or Other||Mean Difference (Final Values)|-2.41|Standard Error of the Mean|0.73||0.0016|2-Sided|95.0|-3.9|-0.9|||ANOVA||||
1727735|NCT00576472|3183509|Superiority or Other||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|1.03||0.8425|2-Sided|95.0|-2.3|1.9|||ANOVA||||
1727736|NCT00576472|3183510|Superiority or Other||Mean Difference (Final Values)|7.99|Standard Error of the Mean|1.81|<|0.0001|2-Sided|95.0|4.4|11.6|||ANOVA||||
1727737|NCT00576472|3183511|Superiority or Other||Mean Difference (Final Values)|-9.56|Standard Error of the Mean|1.3|<|0.0001|2-Sided|95.0|-12.0|-7.0|||ANOVA||||
1727738|NCT00576472|3183512|Superiority or Other||Mean Difference (Final Values)|-8.74|Standard Error of the Mean|1.2|<|0.0001|2-Sided|95.0|-11.0|-6.4|||ANOVA||||
1727739|NCT00576472|3183513|Superiority or Other||Mean Difference (Final Values)|-3.34|Standard Error of the Mean|1.59||0.0413|2-Sided|95.0|-6.5|-0.1|||ANOVA||||
1727740|NCT00576472|3183514|Superiority or Other||Mean Difference (Final Values)|-7.17|Standard Error of the Mean|1.93||0.0005|2-Sided|95.0|-11.0|-3.3|||ANOVA||||
1727741|NCT00576472|3183515|Superiority or Other||Mean Difference (Final Values)|0.00494|Standard Error of the Mean|0.0083||0.552|2-Sided|95.0|-0.00865|0.0185|||ANOVA||||
1727742|NCT00576472|3183515|Superiority or Other||Mean Difference (Final Values)|0.0347|Standard Error of the Mean|0.0047|<|0.0001|2-Sided|95.0|0.025|0.0445|||ANOVA||||
1727743|NCT00576472|3183515|Superiority or Other||Mean Difference (Final Values)|0.0298|Standard Error of the Mean|0.0083|<|0.0004|2-Sided|95.0|0.00974|0.0499|||ANOVA||||
1727744|NCT00576472|3183515|Superiority or Other||Mean Difference (Final Values)|0.0491|Standard Error of the Mean|0.0064|<|0.0001|2-Sided|95.0|0.0396|0.0586|||ANOVA||||
1727745|NCT00576472|3183515|Superiority or Other||Mean Difference (Final Values)|0.0442|Standard Error of the Mean|0.0093|<|0.0001|2-Sided|95.0|0.0292|0.0591|||ANOVA||||
1727746|NCT00576472|3183515|Superiority or Other||Mean Difference (Final Values)|0.0144|Standard Error of the Mean|0.0064|<|0.025|2-Sided|95.0|0.000204|0.0285|||ANOVA||||
1727747|NCT00576472|3183516|Superiority or Other||Mean Difference (Final Values)|0.0285|Standard Error of the Mean|0.0046|<|0.0001|2-Sided|95.0|0.019|0.038|||ANOVA||||
1727748|NCT00576472|3183517|Superiority or Other||Mean Difference (Final Values)|-0.033|Standard Error of the Mean|0.0062|<|0.0001|2-Sided|95.0|-0.0452|-0.0208|||ANOVA||||
1727749|NCT00576420|3183535|Superiority or Other|||||||0.127|||||||Likelihood ratio chi-square test||||
1727750|NCT00576420|3183535|Superiority or Other|||||||0.096|||||||Likelihood ratio chi-square test||||
1727751|NCT00576420|3183535|Superiority or Other|||||||0.257|||||||Likelihood ratio chi-square test||||
1727752|NCT00576420|3183536|Superiority or Other|||||||0.127|||||||Likelihood ratio chi-square test||||
1727753|NCT00576420|3183536|Superiority or Other|||||||0.243|||||||Likelihood ratio chi-square test||||
1727754|NCT00576420|3183536|Superiority or Other|||||||0.106|||||||Likelihood ratio chi-square test||||
1727755|NCT00576420|3183537|Superiority or Other|||||||0.955|||||||Likelihood ratio chi-square test||||
1727756|NCT00576420|3183537|Superiority or Other|||||||0.234|||||||Likelihood ratio chi-square test||||
1727757|NCT00576420|3183539|Superiority or Other|||||||0.228|||||||Likelihood ratio chi-square test||||
1727758|NCT00576420|3183539|Superiority or Other|||||||0.929|||||||Likelihood ratio chi-square test||||
1727759|NCT00576420|3183540|Superiority or Other|||||||0.026|||||||Likelihood ratio chi-square test||||
1727760|NCT00576420|3183540|Superiority or Other|||||||0.123|||||||Likelihood ratio chi-square test||||
1727761|NCT00576420|3183541|Superiority or Other|||||||0.005|||||||Likelihood ratio chi-square test||||
1727762|NCT00576420|3183541|Superiority or Other|||||||0.06|||||||Likelihood ratio chi-square test||||
1727763|NCT00576420|3183543|Superiority or Other|||||||0.1564|||||||Likelihood ratio chi-square test||||
1727764|NCT00576147|3183570|Superiority or Other||Percent Specificity|90.7|||||2-Sided|95.0|86.4|93.7|||||||
1727765|NCT00576147|3183570|Superiority or Other||Percent Sensitivity|88.0|||||2-Sided|95.0|75.0|95.0|||||||
1727766|NCT00575588|3183593|Superiority or Other||Mean Difference (Net)|-0.0035|Standard Error of the Mean|0.0007|||2-Sided|95.0|-0.0048|-0.0022|||||||
1727767|NCT00575588|3183594|Superiority or Other||Mean Difference (Net)|-2.76|Standard Error of the Mean|0.286|||2-Sided|95.0|-3.32|-2.2|||||||
1727768|NCT00575588|3183595|Superiority or Other||Mean Difference (Net)|-34.9|||||2-Sided|95.0|-39.8|-30.0|||||||
1727769|NCT00575588|3183596|Superiority or Other||Mean Difference (Net)|-0.05|Standard Error of the Mean|0.059|||2-Sided|95.0|-0.17|0.06|||||||
1727770|NCT00575588|3183597|Superiority or Other||Mean Difference (Net)|-0.002|Standard Error of the Mean|0.001||0.04|2-Sided|95.0|-0.0046|-0.0001||Between group comparison significant after controlling overall alpha of the study|Mixed Models Analysis||||
1727771|NCT00575588|3183598|Superiority or Other||Mean Difference (Net)|-2.2|Standard Error of the Mean|0.24|<|0.0001||95.0|-2.7|-1.7||Between group comparison significant after controlling overall alpha of the study|ANCOVA||||
1727772|NCT00575588|3183599|Superiority or Other||Mean Difference (Net)|-33.2|||<|0.0001|2-Sided|95.0|-38.1|-28.5||Between group comparison significant after controlling overall alpha of the study|Fisher Exact||||
1727773|NCT00575588|3183600|Superiority or Other||Mean Difference (Net)|0.06|Standard Error of the Mean|0.053|||2-Sided|95.0|-0.05|0.16|||||||
1727774|NCT00575159|3183619|Superiority or Other||Mean Difference (Final Values)|3.659||||0.0001|2-Sided|95.0|2.071|5.246|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean|
1727775|NCT00575159|3183619|Superiority or Other||Mean Difference (Final Values)|2.725||||0.0015|2-Sided|95.0|1.126|4.324|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean|
1727776|NCT00575159|3183619|Superiority or Other||Mean Difference (Final Values)|2.953||||0.0005|2-Sided|95.0|1.411|4.496|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean|
1727777|NCT00575159|3183619|Superiority or Other||Mean Difference (Final Values)|-2.887||||0.0006|2-Sided|95.0|-4.424|-1.35|||ANCOVA|||Difference from placebo to GSK189075 500mg AUC(0-10) Incremental Adjusted Weighted Mean|
1727778|NCT00575159|3183619|Superiority or Other||Mean Difference (Final Values)|-3.82||||0|2-Sided|95.0|-5.304|-2.337|||ANCOVA|||Difference from placebo to GSK189075 150mg AUC(0-10) Incremental Adjusted Weighted Mean|
1727779|NCT00575159|3183619|Superiority or Other||Mean Difference (Net)|-3.592||||0.0001|2-Sided|95.0|-5.162|-2.022|||ANCOVA|||Difference from placebo to GSK189075 50mg AUC(0-10) Incremental Adjusted Weighted Mean|
1727780|NCT00575159|3183619|Superiority or Other||Mean Difference (Final Values)|1.881||||0.0161|2-Sided|95.0|0.373|3.389|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean|
1727781|NCT00575159|3183619|Superiority or Other||Mean Difference (Final Values)|1.958||||0.0132|2-Sided|95.0|0.439|3.477|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean|
1727782|NCT00575159|3183619|Superiority or Other||Mean Difference (Final Values)|1.556||||0.0382|2-Sided|95.0|0.09|3.021|||ANCOVA|||Difference from Placebo+ Prandial insulin to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean|
1727783|NCT00575159|3183619|Superiority or Other||Mean Difference (Final Values)|-2.402||||0.0021|2-Sided|95.0|-3.862|-0.942|||ANCOVA|||Difference from placebo to GSK189075 500mg AUC(0-4) Incremental Adjusted Weighted Mean|
1727784|NCT00575159|3183619|Superiority or Other||Mean Difference (Final Values)|-2.325||||0.0021|2-Sided|95.0|-3.735|-0.916|||ANCOVA|||Difference from placebo toGSK189075 150mg AUC(0-4) Incremental Adjusted Weighted Mean|
1727785|NCT00575159|3183619|Superiority or Other||Median Difference (Final Values)|-2.728||||0.0008|2-Sided|95.0|-4.219|-1.236|||ANCOVA|||Difference from placebo to GSK189075 50mg AUC(0-4) Incremental Adjusted Weighted Mean|
1727786|NCT00575042|3183638|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Sample size calculation estimated that with 20 patients, and assuming a 10% drop-out rate, the study would have 80% power to detect a response rate in 35% or more of the study patients. A two-sided p value<0.05 was considered statistically significant.|
1727787|NCT00574990|3183645|Superiority or Other||chi square|12.99|Standard Error of the Mean|1.4||0.01|2-Sided|||||Differences between roles and communication event content were assessed by Chi squared|Chi-squared|||Descriptive counts and chi squared were done on the observation data.|
1727788|NCT00574912|3183651|Superiority or Other||||||<|0.05|||||||ANOVA||||
1727789|NCT00574873|3183652|Superiority or Other||Hazard Ratio (HR)|0.41|||||2-Sided|95.0|0.13|1.29|||||The hazard ratio (95% confidence interval) is obtained from a Cox model for cause-specific hazard as a function of the covariate treatment (bosutinib compared with imatinib) with stratification by region and Sokal risk group at randomization.||
1727790|NCT00574873|3183653|Superiority or Other||Hazard Ratio (HR)|3.25|||||2-Sided|95.0|0.9|11.72|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.||
1727791|NCT00574873|3183654|Superiority or Other||Hazard Ratio (HR)|0.59|||||2-Sided|95.0|0.32|1.08|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.||
1727792|NCT00574873|3183655|Superiority or Other||Hazard Ratio (HR)|0.64|||||2-Sided|95.0|0.31|1.31|||||Hazard ratio (95% confidence interval) based on the treatment effect (bosutinib compared with imatinib) in a stratified (by Sokal risk group and region at randomization) Cox model for the hazard of the respective event.||
1727793|NCT00574873|3183656|Superiority or Other|||||||0.002||||||p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.|Stratified Cochran-Mantel-Haenszel||||
1727794|NCT00574873|3183657|Superiority or Other|||||||0.667||||||p-value was based on a Cochran Mantel Haenszel test for general association between treatment and responder stratification by Sokal risk group (low, intermediate, high) and region (1 to 3) as determined at time of randomization.|Stratified Cochran-Mantel-Haenszel||||
1727795|NCT00574548|3183691|Superiority or Other||ratio of geometric mean titer|2.9|||||2-Sided|95.0|1.92|4.28|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] – [23vPS / 13vPnC]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727796|NCT00574548|3183691|Superiority or Other||ratio of geometric mean titer|2.5|||||2-Sided|95.0|1.8|3.44|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] – [23vPS / 13vPnC]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727797|NCT00574548|3183691|Superiority or Other||ratio of geometric mean titer|2.5|||||2-Sided|95.0|1.92|3.13|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] – [23vPS / 13vPnC]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727798|NCT00574548|3183691|Superiority or Other||ratio of geometric mean titer|2.8|||||2-Sided|95.0|2.01|3.89|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] – [23vPS / 13vPnC]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727976|NCT00570921|3184074|Superiority or Other||Response Rate Percentage|12.9|||||2-Sided|95.0|3.63|29.83|||||Percentage of Patients with a complete or partial response with 95% exact binomial proportion confidence interval||
1727799|NCT00574548|3183691|Superiority or Other||ratio of geometric mean titer|1.5|||||2-Sided|95.0|1.02|2.18|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] – [23vPS / 13vPnC]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727800|NCT00574548|3183691|Superiority or Other||ratio of geometric mean titer|6.7|||||2-Sided|95.0|4.45|10.22|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] – [23vPS / 13vPnC]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727801|NCT00574548|3183691|Superiority or Other||ratio of geometric mean titer|8.5|||||2-Sided|95.0|5.68|12.6|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] – [23vPS / 13vPnC]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727802|NCT00574548|3183691|Superiority or Other||ratio of geometric mean titer|2.7|||||2-Sided|95.0|1.94|3.88|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] – [23vPS / 13vPnC]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727803|NCT00574548|3183691|Superiority or Other||ratio of geometric mean titer|2.5|||||2-Sided|95.0|1.77|3.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] – [23vPS / 13vPnC]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727804|NCT00574548|3183691|Superiority or Other||ratio of geometric mean titer|2.7|||||2-Sided|95.0|2.07|3.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] – [23vPS / 13vPnC]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727805|NCT00574548|3183691|Superiority or Other||ratio of geometric mean titer|1.5|||||2-Sided|95.0|1.18|1.89|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] – [23vPS / 13vPnC]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727806|NCT00574548|3183691|Superiority or Other||ratio of geometric mean titer|2.7|||||2-Sided|95.0|2.03|3.55|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC] – [23vPS / 13vPnC]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727807|NCT00574548|3183692|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||2-Sided|95.0|0.5|0.73|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727808|NCT00574548|3183692|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.1|||||2-Sided|95.0|0.89|1.39|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727809|NCT00574548|3183692|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||2-Sided|95.0|0.58|0.74|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727810|NCT00574548|3183692|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||2-Sided|95.0|0.58|0.85|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727811|NCT00574548|3183692|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||2-Sided|95.0|0.75|1.15|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727812|NCT00574548|3183692|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.5|||||2-Sided|95.0|0.41|0.69|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727813|NCT00574548|3183692|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.4|||||2-Sided|95.0|0.35|0.52|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1728333|NCT00568685|3184390|Superiority or Other|||||||0.2213||||||This is the p value for weight change at endpoint|ANOVA||||
1727814|NCT00574548|3183692|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||2-Sided|95.0|0.57|0.79|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727815|NCT00574548|3183692|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.8|||||2-Sided|95.0|0.67|1.03|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727816|NCT00574548|3183692|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||2-Sided|95.0|0.49|0.66|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727817|NCT00574548|3183692|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.7|||||2-Sided|95.0|1.52|2.01|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727818|NCT00574548|3183692|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||2-Sided|95.0|0.55|0.75|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727819|NCT00574548|3183693|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.6|||||2-Sided|95.0|1.15|2.13|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 23F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727820|NCT00574548|3183693|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||2-Sided|95.0|0.69|1.15|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727821|NCT00574548|3183693|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||2-Sided|95.0|0.53|0.82|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 19A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727822|NCT00574548|3183693|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||2-Sided|95.0|0.54|0.87|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 18C: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727823|NCT00574548|3183693|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.8|||||2-Sided|95.0|0.6|1.02|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 14: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727824|NCT00574548|3183693|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.4|||||2-Sided|95.0|0.26|0.51|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 9V: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727825|NCT00574548|3183693|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.3|||||2-Sided|95.0|0.24|0.49|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 7F: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727826|NCT00574548|3183693|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||2-Sided|95.0|0.71|1.12|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6B: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727909|NCT00572728|3183921|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)|two‐sided exact p value from Wilcoxon two‐sample test||H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT3 between the RCB 0,I and the RCB II,III groups.|
1727827|NCT00574548|3183693|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.9|||||2-Sided|95.0|0.67|1.08|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 6A: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727828|NCT00574548|3183693|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.6|||||2-Sided|95.0|0.43|0.77|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 5: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727829|NCT00574548|3183693|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.5|||||2-Sided|95.0|0.43|0.68|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 4: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727830|NCT00574548|3183693|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|1.2|||||2-Sided|95.0|0.99|1.49|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 3: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727831|NCT00574548|3183693|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean fold rise greater than 0.5.|Geometric mean fold rise|0.7|||||2-Sided|95.0|0.54|0.82|||||CIs are back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Serotype 1: geometric mean fold rise (GMFR) calculated using all evaluable participants with data from both the postvaccination 1 and postvaccination 2 blood draws.|
1727832|NCT00574548|3183694|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||2-Sided|95.0|1.05|2.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS / 13vPnC]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727833|NCT00574548|3183694|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.7|||||2-Sided|95.0|1.96|3.74|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS / 13vPnC]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727834|NCT00574548|3183694|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||2-Sided|95.0|1.27|2.07|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS / 13vPnC]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727835|NCT00574548|3183694|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.9|||||2-Sided|95.0|1.32|2.69|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS / 13vPnC]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727836|NCT00574548|3183694|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||2-Sided|95.0|0.98|2.1|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS / 13vPnC]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727837|NCT00574548|3183694|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|3.3|||||2-Sided|95.0|1.97|5.45|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS / 13vPnC]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727838|NCT00574548|3183694|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|4.3|||||2-Sided|95.0|2.76|6.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS / 13vPnC]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727883|NCT00573443|3183838|Superiority or Other||Ratio of episode-rate reduction ratios|0.5312|||<|0.0001|2-Sided|95.0|0.4939|0.5714|||Regression, Longitudinal neg. binomial|||Analysis of PBA episode rates used longitudinal negative binomial regression with treatment, period, diagnosis and study site to estimate pre-post changes in log mean episode rate for each treatment group. Null hypothesis of equal pre-post episode rate reductions were tested: AVP-923-30/placebo = 1.|
1727839|NCT00574548|3183694|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||2-Sided|95.0|1.19|2.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS / 13vPnC]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727840|NCT00574548|3183694|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.4|||||2-Sided|95.0|1.67|3.31|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS / 13vPnC]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727841|NCT00574548|3183694|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||2-Sided|95.0|1.12|1.96|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS / 13vPnC]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727842|NCT00574548|3183694|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.5|||||2-Sided|95.0|1.95|3.16|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS / 13vPnC]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727843|NCT00574548|3183694|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.9|||||2-Sided|95.0|1.43|2.57|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS / 13vPnC]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727844|NCT00574548|3183695|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|2.8|||||2-Sided|95.0|1.86|4.35|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS]).|Serotype 23F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727845|NCT00574548|3183695|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||2-Sided|95.0|1.09|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS]).|Serotype 19F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727846|NCT00574548|3183695|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.2|||||2-Sided|95.0|0.96|1.61|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS]).|Serotype 19A: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727847|NCT00574548|3183695|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.3|||||2-Sided|95.0|0.94|1.93|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS]).|Serotype 18C: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727848|NCT00574548|3183695|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|0.8|||||2-Sided|95.0|0.58|1.25|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS]).|Serotype 14: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727849|NCT00574548|3183695|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.3|||||2-Sided|95.0|0.79|2.12|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS]).|Serotype 9V: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727850|NCT00574548|3183695|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||2-Sided|95.0|1.07|2.47|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS]).|Serotype 7F: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727975|NCT00570921|3184073|Superiority or Other||Percentage with clinical benefit|48.39|||||2-Sided|95.0|30.15|66.94|||||Percentage of patients that had a complete response, partial response, or stable disease for 24 weeks or more as defined by RECIST v1.0.||
1727851|NCT00574548|3183695|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||2-Sided|95.0|1.18|2.51|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS]).|Serotype 6B: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727852|NCT00574548|3183695|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||2-Sided|95.0|1.01|2.0|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS]).|Serotype 5: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727853|NCT00574548|3183695|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.0|||||2-Sided|95.0|0.74|1.41|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS]).|Serotype 4: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727854|NCT00574548|3183695|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||2-Sided|95.0|1.24|1.94|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] – [23vPS]).|Serotype 3: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727855|NCT00574548|3183695|Non-Inferiority or Equivalence|Criterion on which to declare non-inferiority = lower bound of the 2-sided 95% confidence interval for the geometric mean ratio greater than 0.5 (2-fold criterion).|ratio of geometric mean titer|1.0|||||2-Sided|95.0|0.75|1.33|||||CIs for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures ([13vPnC / 23vPS] - [23vPS]).|Serotype 1: ratio for GMT calculated by back transformation of the mean difference between vaccine groups on the logarithmic scale.|
1727856|NCT00574249|3183716|Superiority or Other|||||||0.634|||||||ANOVA|One-way ANOVA.|||
1727857|NCT00574249|3183717|Superiority or Other|||||||0.74|||||||ANOVA|One-way ANOVA.|||
1727858|NCT00574249|3183718|Superiority or Other|||||||0.437|||||||ANOVA|One-way ANOVA.|||
1727859|NCT00574249|3183719|Superiority or Other|||||||0.764|||||||ANOVA|One-way ANOVA.|||
1727860|NCT00574249|3183720|Superiority or Other|||||||0.001|||||||ANOVA|One-way ANOVA.|||
1727861|NCT00574249|3183721|Superiority or Other||||||<|0.001|||||||ANOVA|One-way ANOVA.|||
1727862|NCT00574249|3183722|Superiority or Other|||||||0.228|||||||ANOVA|One-way ANOVA.|||
1727863|NCT00574249|3183723|Superiority or Other|||||||0.028|||||||Fisher Exact||||
1727864|NCT00574249|3183724|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1727865|NCT00574249|3183725|Superiority or Other|||||||0.413|||||||Fisher Exact||||
1727866|NCT00574249|3183726|Superiority or Other||Mean Difference (Net)|-17.55||||0.272||95.0|-48.92|13.82|||ANOVA|One-way ANOVA. Confidence interval and difference estimated from adalimumab + calcipotriol/betamethasone minus adalimumab + placebo.|||
1727867|NCT00574249|3183727|Superiority or Other||Mean Difference (Net)|9.74||||0.204||95.0|-5.3|24.78|||ANOVA|One-way ANOVA. For confidence interval and difference estimate, adalimumab + calcipotriol/betamethasone minus adalimumab + placebo was used.|||
1727868|NCT00574249|3183728|Superiority or Other|||||||0.011|||||||Fisher Exact||||
1727869|NCT00574249|3183729|Superiority or Other|||||||0.004|||||||Fisher Exact||||
1727870|NCT00574249|3183730|Superiority or Other|||||||0.003|||||||Fisher Exact||||
1727871|NCT00574249|3183731|Superiority or Other|||||||0.002|||||||Fisher Exact||||
1727872|NCT00574249|3183732|Superiority or Other|||||||0.565|||||||Fisher Exact||||
1727873|NCT00574249|3183733|Superiority or Other|||||||0.086||||||Level of significance 5%; no adjustment for multiple comparisons necessary.|Cochran-Mantel-Haenszel|Two-sided CMH test stratified by country at the alpha level 0.05. Centers were pooled by country (Sweden and Finland pooled due to few participants).||Comparison of the proportion of participants in the adalimumab + calcipotriol/betamethasone group vs. the adalimumab + placebo group.|
1727874|NCT00573859|3183773|Superiority or Other||||||<|0.05|||||||Friedman's two analysis of ranks|||Friedman's two-way analysis of variance by ranks.|
1727875|NCT00573859|3183774|Superiority or Other||||||<|0.05|||||||ANOVA|||Four-way repeated measure ANOVA|
1727876|NCT00573859|3183775|Superiority or Other||||||<|0.05|||||||ANOVA|||A 2 (ADHD medication versus Placebo) repeated measure ANOVA|
1727877|NCT00573508|3183815|Superiority or Other||Least Square Mean Difference|-16.8|||<|0.0001||95.0|-22.1|-11.6|||ANCOVA|||Statistical Analysis applies to 'Change at EOT'.|
1727878|NCT00573508|3183823|Superiority or Other|||||||0.0006|||||||ANCOVA||||
1727879|NCT00573508|3183824|Superiority or Other||||||<|0.0001||||||P-Value represents change from Baseline to Week 12.|ANCOVA|||Statistical Analysis applies to 'Change at Week 12'.|
1727880|NCT00573508|3183825|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Statistical Analysis applies to 'Change at Week 4', 'Change at Week 8' and 'Change at Week 12'.|
1727881|NCT00573508|3183826|Superiority or Other||Least Square Mean Difference|9.4|||<|0.0001||95.0|6.6|12.2|||ANCOVA|||Statistical Analysis applies to 'Change at End of Treatment'.|
1727882|NCT00573443|3183838|Superiority or Other||Ratio of episode-rate reduction ratios|0.5103|||<|0.0001|2-Sided|95.0|0.4755|0.5477|||Regression, Longitudinal neg. binomial|||Analysis of PBA episode rates used longitudinal negative binomial regression with treatment, period, diagnosis and study site to estimate pre-post changes in log mean episode rate for each treatment group. Null hypothesis of equal pre-post episode rate reductions were tested: AVP-923-20/placebo = 1.|
1727884|NCT00573313|3183845|Superiority or Other||Ratio of Geometric Means at 24 weeks.|0.1505|Standard Error of the Mean|0.1615||0.36|2-Sided|95.0|-0.1853|0.4863||The data provided here are for changes in serum AST levels as representative of all clinical laboratory parameters measured.|ANCOVA|Analysis of covariance controlled for baseline data, e.g. AST.|Obtained median values and ranges and log transformations of SD.|Power calculation indicated that a sample size of 20 subjects per treatment arm would detect differences between groups of 0.9 within-subject standard deviations or higher at 80% power and 5% level of significance.|
1727885|NCT00573248|3183860|Superiority or Other||||||<|0.025||||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item|
1727886|NCT00573248|3183861|Superiority or Other||||||<|0.025||||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item|
1727887|NCT00573248|3183862|Superiority or Other||||||<|0.025|||||||ANOVA|||2 (nicotine versus placebo) x 2 (smoker versus nonsmoker) ANOVA|
1727888|NCT00573248|3183863|Superiority or Other||||||<|0.025||||||Adjusted for multiple comparisons|ANOVA|||2 (nicotine versus placebo) x 2 (smokers versus nonsmokers) ANOVA for each diary item|
1727889|NCT00573183|3183864|Superiority or Other||||||<|0.05||||||Statistical Model - zero-inflated negative binomial random-effects regression|Zero-inflated negative binomial random-e|Statistical Model - zero-inflated negative binomial random-effects regression adjusted for average number of days of pre-baseline attendance||Outcome measure: Number of days of self-reported Self-Help meeting attendance by the Substance Use Calendar (SUC) within a 30-day window of assessment at mid-treatment, end-of-treatment, first, second, third and last follow-ups|
1727890|NCT00573183|3183865|Superiority or Other||Odds Ratio (OR)|2.4373|Standard Error of the Mean|0.4134|<|0.01|2-Sided|95.0|1.0131|5.8637|||Mixed Models Analysis||||
1727891|NCT00573183|3183865|Superiority or Other||Odds Ratio (OR)|3.3404|Standard Error of the Mean|0.4134|<|0.05|2-Sided|95.0|1.2019|9.2842||95% confidence interval|Mixed Models Analysis|A covariate adjustment was used: average number of days of stimulant use within a 30-day window of assessment from 90 days pre-baseline to baseline.|The STAGE-12 group represented the numerator and TAU represented the reference group/denominator|Mixture model with a logistic part for assessing zero-inflation and a negative binomial part for the over-dispersed count data, with corresponding 95% confidence intervals (CIs) of the odds ratios for logistic part and incidence rate ratios for negative binomial part.|
1727892|NCT00573170|3183888|Superiority or Other||Odds Ratio (OR)|1.3||||0.378|2-Sided|95.0|0.7|2.5||Compares odds ratio.|Generalized Estimating Equations||||
1727893|NCT00573144|3183892|Superiority or Other|||||||0.26|||||||t-test, 2 sided||||
1727894|NCT00573144|3183893|Superiority or Other|||||||0.35|||||||t-test, 2 sided||||
1727895|NCT00573144|3183894|Superiority or Other|||||||0.97|||||||t-test, 2 sided||||
1727896|NCT00572936|3183897|Equivalence|Kruskal-Wallis test was used to compare the differences in uveoscleral outflow between the three interventions|||||<|0.05||||||threshold for statistical analysis was <0.05|Kruskal-Wallis||||
1727897|NCT00572936|3183898|Equivalence|Kruskal-Wallis test was used to compare the differences between outflow facility for the three interventions|||||<|0.05||||||threshold for statistical significance was <0.05|Kruskal-Wallis||||
1727898|NCT00572936|3183899|Equivalence|ANOVA was performed to compare the results between the three interventions.||||||0.89||||||threshold for statistical significance was <0.05|ANOVA||||
1727899|NCT00572936|3183900|Equivalence|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for statistical significance was <0.05|ANOVA||||
1727900|NCT00572936|3183901|Equivalence|ANOVA was performed to compare the results between the three interventions.||||||0.84||||||threshold for statistical significance was <0.05|ANOVA||||
1727901|NCT00572936|3183902|Equivalence|ANOVA was performed to compare the results between the three interventions.||||||0.93||||||threshold for statistical significance was <0.05|ANOVA||||
1727902|NCT00572936|3183903|Equivalence|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for statistical significance was <0.05|ANOVA||||
1727903|NCT00572936|3183904|Equivalence|ANOVA was performed to compare the results between the three interventions.|||||<|0.05||||||threshold for significance was <0.05|ANOVA||||
1727904|NCT00572832|3183917|Non-Inferiority or Equivalence|The formula used for calculating sample size for the treatment arm (NT) is NT = (1 + 1/u) (Zα + Zβ)2 σ2 /[log (RGMC) −δ0] where u is the ratio of the size of the control and treatment arms, one sided alpha that is divided by 4, a non-inferiority margin (δ0 of natural log 0.5), the expected ratio of geometric mean concentrations RGMC set at 0.8, and a standard deviation of 1.26 (the largest for HPV-16). The calculated sample size for a power of 80% was 75 participants in each arm.||||||0.025||||||Non-inferiority was tested against a one-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type. Results: GMT ratios were 2.23, 3,17, 2.14, and 1.68 for types 6,11,16,& 18.|ANOVA|Log transformed the data and calculated GMTs. Tested if post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type||Non-inferiority tested against 1-sided null hypothesis (alpha=.025) that the post Dose 3 GMT ratio of the Alternate to Standard schedule was ≤ 0.5 for each HPV type|
1727905|NCT00572728|3183918|Superiority or Other|||||||0.67||||||two‐sided p value from Kruskal‐Wallis one‐way ANOVA|Kruskal-Wallis||||
1727906|NCT00572728|3183919|Superiority or Other|||||||0.86|||||||Kruskal-Wallis|two‐sided p value from Kruskal‐Wallis one‐way ANOVA||"Kruskal‐Wallis one‐way ANOVA was used to test whether there was a difference in %SUVmax (FLT1-FLT2) among LN statuses.~H0: no difference between the 3 LN status."|
1727907|NCT00572728|3183920|Superiority or Other||AUC|0.83|||<|0.001|2-Sided|90.0|0.72|0.94||Delong 1-sided p-value (alpha=0.05)|Delong Method|The Delong-Delong Clark-Pearson method using modified U-statistics was used to evaluate the AUC||"ROC analysis was used to compute the AUC and evaluate if %ΔSUVmax FLT1‐FLT3 is predictive of pCR with alpha=0.05.~The Null Hypothesis assumes that the P(%ΔSUVmax FLT1‐FLT3|pCR)= 1 - P(%ΔSUVmax FLT1‐FLT3|non-pCR) that is: H0: AUC =0.5 (guessing)"|
1727908|NCT00572728|3183921|Superiority or Other||Odds Ratio (OR)|0.86||||0.013|2-Sided|95.0|0.76|0.97|||Regression, Logistic|||H0: %SUVmax FLT1‐FLT3 (RCB 0,I) = %SUVmax FLT1‐FLT3 (RCB II,III) A logistic regression model is used to determine if a larger percent change in SUVmax is associated with (RCB 0,I); the null hypothesis assumes that there is no association.|
1727910|NCT00572728|3183922|Superiority or Other|||||||0.86|||||||Wilcoxon (Mann-Whitney)|*two‐sided exact p value from Wilcoxon two‐sample test||H0: SUVmax (RCB 0,I) = SUVmax (RCB II,III) in other words, we are comparing the SUVmax @ FLT2 between the RCB 0,I and the RCB II,III groups.|
1727911|NCT00572728|3183923|Superiority or Other|||||||0.66|||||||Wilcoxon (Mann-Whitney)|two‐sided exact p value from Wilcoxon two‐sample test||"H0: Mean SUVmax (RCB 0,I) = Mean SUVmax (RCB II,III) After dichotomization, Wilcoxon two-sample test was used to compare uptake values between RCB groups.~In other words, we are comparing the means (of SUVmax) @ FLT1 between the RCB 0,I and the RCB II,III groups.."|
1727912|NCT00572728|3183924|Superiority or Other||Spearman Correlation|0.67|||<|0.0001|2-Sided|95.0|0.47|0.81|||Spearman Correlation method|we use Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|this estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-3 and Ki-67 LI|
1727913|NCT00572728|3183925|Superiority or Other||spearman correlation|0.35||||0.002|2-Sided|95.0|0.13|0.54|||spearman correlation method||This estimate uses the Fisher's z Transformation to adjust for bias in the Spearman Correlation Statistic|H0: ρ = 0; that is, there is no correlation between SUVmax @ FLT-1 and Ki-67 LI a Fisher's z Transformation was applied to adjust for bias in the Spearman Correlation Statistic|
1727914|NCT00572728|3183926|Superiority or Other||AUC|0.68|Standard Error of the Mean|0.1||0.046|1-Sided|95.0||0.83||The Delong method was used to test if the observed AUC was significantly different than 0.5 with the one‐sided p value DeLong ER, DeLong DM, Clarke‐Pearson DL, Biometrics (1988)|Delong method|one‐sided p-value|"percent change in SUVmax was computed as: %ΔSUVmax = 100*(FLT1‐FLT2)/FLT1 a 90% 2-sided confidence interval was constructed from 2000 Bootstrapping estimates from which the 1-sided 95% CI was derived.~Hanley SE(AUC) reported."|"A receiver operating characteristic (ROC) analysis was performed to assess the significance of the Area Under the Curve (AUC) under the Null Hypothesis with a one sided alpha=0.05 (95% one-sided CL):~H0: AUC = 0.50 (no difference from guessing) given the alternative hypothesis: Ha:AUC >= 0.75 AUC = ROC(%ΔSUVmax| path response) where percent change (%ΔSUVmax ) was defined as (SUVmax at FLT1 –SUVmax at FLT2)/SUVmax at FLT1 x 100"|
1727915|NCT00572195|3183957|Other||Slope|0.0||||0.6729|2-Sided|95.0|-0.2|0.1|||Generalized estimating equation (GEE)||||
1727916|NCT00572195|3183957|Other||GEE estimated intercept|48.0|||<|0.0001|2-Sided|95.0|46.8|49.2|||Generalized estimating equation (GEE)||||
1727917|NCT00572195|3183959|Other||||||<|0.05||||||For all 6-month periods, from 6 months through 9 years post-implant, p <0.05.|Wilcoxon Signed Rank Test||||
1727918|NCT00572195|3183960|Other||Wilson score interval|77.0|||||2-Sided|95.0|71.1|81.9|||||The value is for all serious adverse events, regardless of device relation.||95% confidence interval estimated using the Wilson score interval
1727919|NCT00572039|3183978|Superiority or Other||Mean Difference (Net)|0.4||||0.7|2-Sided|95.0|-1.96|2.77|||ANCOVA|||To test the efficacy of PST to improve NE-VFQ scores at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average NEI-VFQ scores were examined, adjusting for baseline score and the vision severity stratification variable.|
1727920|NCT00572039|3183979|Superiority or Other||Mean Difference (Net)|0.079||||0.47|2-Sided|95.0|-0.14|0.29|||ANCOVA|||To test the efficacy of PST to improve TVF functional reserve measures at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average TVF scores were examined, adjusting for baseline TVF score and the vision severity stratification variable. To approximate an interval scale and compensate for ceiling and floor effects, we linearized TVF scores using a logit transform. 106 PST and 112 ST participants provided data at 3 months.|
1727921|NCT00571974|3183982|Superiority or Other|||||||0.0001||||||One-sided exact binomial test to compare the observed response rate to the 20% rate envisioned under the original null hypothesis.|One-sided exact binomial test|Because all but one subject responded to treatment, the Fisher’s exact test was addedd.||The Simon two-stage minimax design with 9 subjects in the first stage and 8 subjects in the second stage, yielding 17 subjects overall. This design’s early termination rule was ≤3/9 responses in the first stage, and its success criterion was ≥7/17 responses overall. This design had 80% power at 5% alpha to distinguish an efficacious 50% response rate from a null-hypothesis 20% response rate.|
1727922|NCT00571701|3183991|Superiority or Other||||||>|0.56|||||||t-test, 2 sided||||
1727923|NCT00571701|3183992|Superiority or Other||||||>|0.5||||||Adjusted for multiple comparisons|Fisher Exact||||
1727924|NCT00571701|3183993|Superiority or Other|||||||1||||||Adjusted for multiple comparisons|Fisher Exact||||
1727925|NCT00571701|3183994|Superiority or Other||||||>|0.3||||||Adjusted for multiple comparisons|Fisher Exact||||
1727926|NCT00571701|3183995|Superiority or Other|||||||0.43|||||||Fisher Exact||||
1727927|NCT00571701|3183996|Superiority or Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)||||
1727928|NCT00571649|3184003|Superiority or Other||Risk Ratio (RR)|2.272|||<|0.0001|2-Sided|95.0|1.628|3.171||2-sided p-value. No adjustment for multiple testing.|Cochran-Mantel-Haenszel|||There was no sample size estimation as this was not planed as confirmatory analysis|
1727929|NCT00571649|3184004|Superiority or Other||Risk Ratio (RR)|2.455|||<|0.0001|2-Sided|95.0|1.854|3.251||2-sided p-value. No adjustment for multiple testing.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||There was no sample size estimation as this was not planed as confirmatory analysis|
1727930|NCT00571649|3184013|Superiority or Other||Risk Ratio (RR)|0.991||||0.9473||95.0|0.753|1.304||Test hierarchy: A p-value of less than 0.05 would be considered significant, if the tests for the 2 primary efficacy outcomes and for “Composite endpoint of VTE (any DVT, non fatal PE) and all-cause mortality up to Day 35 + 6 days” were significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).|||
1727931|NCT00571649|3184014|Superiority or Other||Risk Ratio (RR)|0.931||||0.3758||95.0|0.795|1.091||Test hierarchy: A p-value of less than 0.05 would be considered significant, if the tests for the two primary efficacy outcome measures were significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).|||
1728334|NCT00568685|3184391|Superiority or Other|||||||0.6419||||||This is the p value for diastolic change at endpoint|ANOVA||||
1727932|NCT00571649|3184015|Non-Inferiority or Equivalence|Rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI (Confidence Interval) was less than 1.5|Risk Ratio (RR)|0.968||||0.0025||95.0|0.713|1.314||Hochberg procedure: A 1-sided p-value of less than 0.025 would be considered significant, if the 2-sided p-value of the other primary efficacy outcome measure was less than 0.05, elsewise a p-value of less than 0.0125 would be considered significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||A sample size of 2876 valid patients per group was estimated to obtain a joint power of at least 90% for both primary endpoints (98.6% power for non-inferiority) with 1.8% event rate at day 10 for comparator and 35% relative risk reduction.|
1727933|NCT00571649|3184016|Superiority or Other||Risk Ratio (RR)|0.771||||0.0211||95.0|0.618|0.962||Hochberg procedure: A 2-sided p-value of less than 0.05 would be considered significant, if the 1-sided p-value of the other primary efficacy outcome measure was less than 0.025, elsewise a p-value of less than 0.025 would be considered significant.|Cochran-Mantel-Haenszel|Weighted relative risks were calculated using asymptotic methods, with weights based upon sample sizes per strata (geographic region).||A sample size of 2876 valid patients per group was estimated to obtain a joint power of at least 90% for both primary endpoints (91.4% for superiority) with 4% event rate at day 35 for comparator and 40% relative risk reduction.|
1727934|NCT00571428|3184024|Non-Inferiority or Equivalence|Equivalence was defined a priori such that 90%CI for the difference between therapies had to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.052||||||90.0|0.015|0.09|||||||
1727935|NCT00571428|3184025|Superiority or Other||Mean Difference (Final Values)|1.694||||||90.0|0.525|2.862|||||||
1727936|NCT00571428|3184030|Non-Inferiority or Equivalence|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Median Difference (Final Values)|-0.03||||||90.0|-0.086|0.026|||||||
1727937|NCT00571428|3184031|Non-Inferiority or Equivalence|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Median Difference (Final Values)|-0.035||||||90.0|-0.079|0.008|||||||
1727938|NCT00571428|3184032|Non-Inferiority or Equivalence|Equivalence was defined a priori such that 90%CI for the difference between therapies has to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.062||||||90.0|0.035|0.09|||||||
1727939|NCT00571428|3184033|Non-Inferiority or Equivalence|Equivalence was defined a priori such that 90%CI for the difference between therapies had to fall entirely within +/- 0.07L.|Mean Difference (Final Values)|0.011||||||90.0|-0.015|0.037|||||||
1727940|NCT00571103|3184039|Superiority or Other||Mean Slope|-0.985|Standard Error of the Mean|0.158||0.05|2-Sided|95.0|-1.0|1.0|||Linear mixed effects||||
1727941|NCT00571064|3184041|Superiority or Other|||||||0.4724||||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF - Study Endpoint|
1727942|NCT00571064|3184041|Superiority or Other|||||||0.4724||||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)|
1727943|NCT00571064|3184041|Superiority or Other|||||||0.2327||||||Significance level of 0.05|t-test, 2 sided|||Week 6 (Visit 3)|
1727944|NCT00571064|3184043|Superiority or Other|||||||0.1285||||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)|
1727945|NCT00571064|3184043|Superiority or Other|||||||0.1285||||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)|
1727946|NCT00571064|3184045|Superiority or Other|||||||0.0431||||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)|
1727947|NCT00571064|3184045|Superiority or Other|||||||0.0431||||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)|
1727948|NCT00571064|3184047|Superiority or Other||||||<|0.0001||||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)|
1727949|NCT00571064|3184047|Superiority or Other||||||<|0.0001||||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)|
1727950|NCT00571064|3184047|Superiority or Other||||||<|0.0001||||||Significance level 0.05|t-test, 2 sided|||Week 6 (Visit 3)|
1727951|NCT00571064|3184048|Superiority or Other|||||||0.5924||||||Significance level of 0.05|t-test, 2 sided|||Week 12 LOCF (Study Endpoint)|
1727952|NCT00571064|3184048|Superiority or Other|||||||0.6048||||||Significance level of 0.05|t-test, 2 sided|||Week 12/ET (Visit 4)|
1727953|NCT00571064|3184048|Superiority or Other|||||||0.6593||||||Significance level of 0.05|t-test, 2 sided|||Week 6 (Visit 3)|
1727954|NCT00571038|3184051|Superiority or Other|||||||0.9839|||||||Kruskal-Wallis||||
1727955|NCT00571038|3184052|Superiority or Other|||||||0.7314|||||||Kruskal-Wallis||||
1727956|NCT00571038|3184053|Superiority or Other|||||||0.2527|||||||Kruskal-Wallis||||
1727957|NCT00571038|3184054|Superiority or Other|||||||0.4489|||||||Kruskal-Wallis||||
1727958|NCT00571038|3184055|Superiority or Other|||||||0.5861|||||||Kruskal-Wallis||||
1727959|NCT00571038|3184056|Superiority or Other|||||||0.6123|||||||Kruskal-Wallis||||
1727960|NCT00571038|3184057|Superiority or Other|||||||0.1471|||||||Kruskal-Wallis||||
1727961|NCT00571038|3184058|Superiority or Other|||||||0.3979|||||||Kruskal-Wallis||||
1727962|NCT00571038|3184059|Superiority or Other|||||||0.982|||||||Kruskal-Wallis||||
1727963|NCT00571038|3184060|Superiority or Other|||||||0.5901|||||||Kruskal-Wallis||||
1727964|NCT00571038|3184061|Superiority or Other|||||||0.9633|||||||Kruskal-Wallis||||
1727965|NCT00571038|3184062|Superiority or Other|||||||0.9191|||||||Kruskal-Wallis||||
1727966|NCT00571038|3184063|Superiority or Other|||||||0.2194|||||||Kruskal-Wallis||||
1727967|NCT00571038|3184064|Superiority or Other|||||||0.8395|||||||Kruskal-Wallis||||
1727968|NCT00571038|3184065|Superiority or Other|||||||0.007|||||||Fisher Exact|Two-sided Pr <= P|||
1727969|NCT00571038|3184066|Superiority or Other|||||||0.1418|||||||Kruskal-Wallis||||
1727970|NCT00571038|3184067|Superiority or Other|||||||0.0438|||||||Kruskal-Wallis||||
1727971|NCT00571038|3184068|Superiority or Other|||||||0.0604|||||||Mixed Models Analysis||||
1727972|NCT00571038|3184069|Superiority or Other|||||||0.0432|||||||Mixed Models Analysis||||
1727973|NCT00571038|3184070|Superiority or Other|||||||0.8586|||||||Mixed Models Analysis||||
1727974|NCT00571038|3184071|Superiority or Other|||||||0.2417|||||||Mixed Models Analysis||||
1727977|NCT00570921|3184075|Superiority or Other||Median Time to Progression|7.4|||||2-Sided|95.0|1.9|12.1||||||We hypothesized that median time to progression (TTP) in our trial will increase from 3.7 months for the historical fulvestrant-only control to 7.0 months on the combination of fulvestrant and everolimus in the current trial. A sample of 40 evaluable patients was calculated to show the increase in TTP with 80% power and 5% significance level based on a two sided test of differences in survival times between historical controls and treated group.|
1727978|NCT00570765|3184081|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Tx arms will be compared using the 2-sided Wilcoxon-Mann-Whitney test, at 5% significance level. Tx groups will be pairwise compared vs. placebo.|||
1727979|NCT00570765|3184082|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Tx arms will be compared using the 2-sided Wilcoxon-Mann-Whitney test, at 5% significance level. Tx groups will be pairwise compared vs. placebo.|||
1727980|NCT00570765|3184083|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Tx arms will be compared using the 2-sided Wilcoxon-Mann-Whitney test, at 5% significance level. Tx groups will be pairwise compared vs. placebo.||Hierarchical testing strategy is proposed to account for multiple comparisons. The statistical significance will be evaluated as follows: if statistical significance at alpha=0.05 is shown for the 10mg INT-747 vs. placebo, then we may proceed to evaluate the statistical significance at alpha=0.05 for the 50mg INT-747 versus placebo. If no stat. significance is shown at alpha=0.05 at the first step, then the subsequent comparison should not be considered statistically significant.|
1727981|NCT00570739|3184085|Superiority or Other|||||||0.1037|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1727982|NCT00570739|3184085|Superiority or Other|||||||0.0829|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks|
1727983|NCT00570739|3184085|Superiority or Other||Odds Ratio (OR)|2.22||||0.1996|2-Sided|95.0|0.85|5.82|||Cochran-Mantel-Haenszel|P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.||Baseline to 16 Weeks LOCF|
1727984|NCT00570739|3184085|Superiority or Other||Odds Ratio (OR)|2.43||||0.1375|2-Sided|95.0|0.89|6.64||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks|
1727985|NCT00570739|3184086|Superiority or Other|||||||0.4395|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1727986|NCT00570739|3184086|Superiority or Other|||||||0.2768|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks|
1727987|NCT00570739|3184086|Superiority or Other||Odds Ratio (OR)|0.75||||0.6667|2-Sided|95.0|0.37|1.55||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF|
1727988|NCT00570739|3184086|Superiority or Other||Odds Ratio (OR)|0.66||||0.4794|2-Sided|95.0|0.31|1.4||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks|
1727989|NCT00570739|3184087|Superiority or Other|||||||0.0593|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1727990|NCT00570739|3184087|Superiority or Other|||||||0.224|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks|
1727991|NCT00570739|3184087|Superiority or Other||Odds Ratio (OR)|2.08||||0.042|2-Sided|95.0|0.97|4.45||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF|
1727992|NCT00570739|3184087|Superiority or Other||Odds Ratio (OR)|1.62||||0.1499|2-Sided|95.0|0.74|3.55||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks|
1727993|NCT00570739|3184087|Superiority or Other|||||||0.0254||||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 12 Weeks|
1727994|NCT00570739|3184087|Superiority or Other|||||||0.4058||||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks|
1727995|NCT00570739|3184087|Superiority or Other||||||<|0.0001||||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 4 Weeks|
1727996|NCT00570739|3184088|Superiority or Other|||||||0.9774|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1727997|NCT00570739|3184088|Superiority or Other|||||||0.7783|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks|
1727998|NCT00570739|3184088|Superiority or Other||Odds Ratio (OR)|0.98||||0.996|2-Sided|95.0|0.32|3.03||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF|
1727999|NCT00570739|3184088|Superiority or Other||Odds Ratio (OR)|0.84||||0.7994|2-Sided|95.0|0.25|2.29||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks|
1728000|NCT00570739|3184088|Superiority or Other|||||||0.5752||||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 12 Weeks|
1728001|NCT00570739|3184088|Superiority or Other|||||||0.4053||||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks|
1728002|NCT00570739|3184088|Superiority or Other|||||||0.2079||||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country|Cochran-Mantel-Haenszel|||Baseline to 4 Weeks|
1728003|NCT00570739|3184089|Superiority or Other|||||||0.8461|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728004|NCT00570739|3184089|Superiority or Other|||||||0.6835|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks|
1728335|NCT00568685|3184391|Superiority or Other|||||||0.9761||||||This is the p value for systolic change at endpoint|ANOVA||||
1728005|NCT00570739|3184089|Superiority or Other||Odds Ratio (OR)|0.93||||0.7098|2-Sided|95.0|0.44|1.96||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF|
1728006|NCT00570739|3184089|Superiority or Other||Odds Ratio (OR)|0.85||||0.5882|2-Sided|95.0|0.4|1.83||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks|
1728007|NCT00570739|3184090|Superiority or Other||Mean Difference (Final Values)|-4.8||||0.5267|2-Sided|95.0|-19.72|10.13||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728008|NCT00570739|3184090|Superiority or Other||Mean Difference (Final Values)|-3.0||||0.7051|2-Sided|95.0|-18.64|12.64||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728009|NCT00570739|3184091|Superiority or Other||Mean Difference (Final Values)|-0.0112||||0.0585|2-Sided|95.0|-0.0228|0.0004||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728010|NCT00570739|3184091|Superiority or Other||Mean Difference (Final Values)|-0.0116||||0.0678|2-Sided|95.0|-0.0241|0.0009||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728011|NCT00570739|3184092|Superiority or Other||Mean Difference (Final Values)|-0.62||||0.5475|2-Sided|95.0|-2.64|1.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728012|NCT00570739|3184092|Superiority or Other||Mean Difference (Final Values)|-0.68||||0.5353|2-Sided|95.0|-2.84|1.48||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728013|NCT00570739|3184093|Superiority or Other|||||||0.2785|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728014|NCT00570739|3184093|Superiority or Other|||||||0.2778|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks|
1728015|NCT00570739|3184093|Superiority or Other||Odds Ratio (OR)|2.21||||0.199|2-Sided|95.0|0.53|9.33||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF|
1728016|NCT00570739|3184093|Superiority or Other||Odds Ratio (OR)|2.22||||0.2224|2-Sided|95.0|0.53|9.39||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks|
1728017|NCT00570739|3184093|Superiority or Other|||||||0.0104||||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks|
1728018|NCT00570739|3184094|Superiority or Other|||||||0.0007|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728019|NCT00570739|3184094|Superiority or Other|||||||0.0005|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks|
1728020|NCT00570739|3184094|Superiority or Other||Odds Ratio (OR)|4.46||||0.0019|2-Sided|95.0|1.89|10.54||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF|
1728021|NCT00570739|3184094|Superiority or Other||Odds Ratio (OR)|5.23||||0.0018|2-Sided|95.0|2.06|13.58||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks|
1728022|NCT00570739|3184094|Superiority or Other||||||<|0.0001||||||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 8 Weeks|
1728023|NCT00570739|3184095|Superiority or Other||Mean Difference (Final Values)|0.029||||0.9476|2-Sided|95.0|-0.853|0.911||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728024|NCT00570739|3184095|Superiority or Other||Mean Difference (Final Values)|-0.151||||0.7447|2-Sided|95.0|-1.068|0.765||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728025|NCT00570739|3184096|Superiority or Other||Mean Difference (Final Values)|-5.17||||0.5369|2-Sided|95.0|-21.661|11.321||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728026|NCT00570739|3184096|Superiority or Other||Mean Difference (Final Values)|-6.91||||0.4301|2-Sided|95.0|-24.156|10.336||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728027|NCT00570739|3184097|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.7513|2-Sided|95.0|-13.5|9.7||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728028|NCT00570739|3184097|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.8192|2-Sided|95.0|-13.7|10.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728029|NCT00570739|3184098|Superiority or Other||Mean Difference (Final Values)|-8.2||||0.1412|2-Sided|95.0|-19.2|2.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728030|NCT00570739|3184098|Superiority or Other||Mean Difference (Final Values)|-7.0||||0.233||95.0|-18.5|4.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728031|NCT00570739|3184099|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.7975|2-Sided|95.0|-10.5|8.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728032|NCT00570739|3184099|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.8583|2-Sided|95.0|-10.7|8.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728033|NCT00570739|3184100|Superiority or Other||Mean Difference (Final Values)|-0.105||||0.4554|2-Sided|95.0|-0.383|0.172||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728034|NCT00570739|3184100|Superiority or Other||Mean Difference (Final Values)|-0.089||||0.553|2-Sided|95.0|-0.385|0.207||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728035|NCT00570739|3184101|Superiority or Other||Mean Difference (Final Values)|-0.493||||0.7314|2-Sided|95.0|-3.321|2.335|||ANCOVA|||Baseline to 16 Weeks LOCF|
1728036|NCT00570739|3184101|Superiority or Other||Mean Difference (Final Values)|-0.434||||0.7858|2-Sided|95.0|-3.583|2.715|||ANCOVA|||Baseline to 16 Weeks|
1728037|NCT00570739|3184101|Superiority or Other||Mean Difference (Final Values)|-1.218||||0.0413|2-Sided|95.0|-2.388|-0.049|||ANCOVA|||Baseline to 12 Weeks|
1728038|NCT00570739|3184101|Superiority or Other||Mean Difference (Final Values)|0.695||||0.2361|2-Sided|95.0|-0.458|1.848||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks|
1728039|NCT00570739|3184101|Superiority or Other||Mean Difference (Final Values)|0.921||||0.2982|2-Sided|95.0|-0.821|2.663||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks|
1728040|NCT00570739|3184102|Superiority or Other||Mean Difference (Final Values)|-2.6||||0.2372|2-Sided|95.0|-7.0|1.7||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728041|NCT00570739|3184102|Superiority or Other||Mean Difference (Final Values)|-2.3||||0.3617|2-Sided|95.0|-7.2|2.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728042|NCT00570739|3184102|Superiority or Other||Mean Difference (Final Values)|-2.8||||0.0615|2-Sided|95.0|-5.8|0.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 12 Weeks|
1728043|NCT00570739|3184102|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.1184|2-Sided|95.0|-4.5|0.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks|
1728044|NCT00570739|3184102|Superiority or Other||Mean Difference (Final Values)|-4.3||||0.0009|2-Sided|95.0|-6.8|-1.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks|
1728045|NCT00570739|3184103|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.0206|2-Sided|95.0|-0.18|-0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728046|NCT00570739|3184103|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.079|2-Sided|95.0|-0.17|0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728047|NCT00570739|3184103|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.1081|2-Sided|95.0|-0.13|0.01||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 12 Weeks|
1728048|NCT00570739|3184103|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.2567|2-Sided|95.0|-0.11|0.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks|
1728049|NCT00570739|3184103|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.2971|2-Sided|95.0|-0.11|0.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 4 Weeks|
1728050|NCT00570739|3184104|Superiority or Other||Mean Difference (Final Values)|1.5||||0.1054|2-Sided|95.0|-0.3|3.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated High Density Lipoprotein-Cholesterol|
1728051|NCT00570739|3184104|Superiority or Other||Mean Difference (Final Values)|1.5||||0.1257|2-Sided|95.0|-0.4|3.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated High Density Lipoprotein-Cholesterol|
1728052|NCT00570739|3184104|Superiority or Other||Mean Difference (Final Values)|26.5||||0.0003|2-Sided|95.0|12.5|40.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes: Calculated Very Low Density Triglycerides|
1728053|NCT00570739|3184104|Superiority or Other||Mean Difference (Final Values)|26.3||||0.0006|2-Sided|95.0|11.5|41.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes: Calculated Very Low Density Triglycerides|
1728054|NCT00570739|3184104|Superiority or Other||Mean Difference (Final Values)|24.3||||0.0013|2-Sided|95.0|9.6|39.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated Total Triglycerides|
1728055|NCT00570739|3184104|Superiority or Other||Mean Difference (Final Values)|24.4||||0.0022|2-Sided|95.0|8.9|39.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Changes in Calculated Total Triglycerides|
1728056|NCT00570739|3184105|Superiority or Other||Mean Difference (Final Values)|0.1||||0.002|2-Sided|95.0|0.04|0.16||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles|
1728057|NCT00570739|3184105|Superiority or Other||Mean Difference (Final Values)|0.09||||0.0063|2-Sided|95.0|0.03|0.16||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles|
1728058|NCT00570739|3184105|Superiority or Other||Mean Difference (Final Values)|-0.11||||0.187|2-Sided|95.0|-0.28|0.06|||ANCOVA|||Low Density Lipoprotein Particles|
1728059|NCT00570739|3184105|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.1742|2-Sided|95.0|-0.3|0.05||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotein Particles|
1728060|NCT00570739|3184105|Superiority or Other||Mean Difference (Final Values)|5.31|||<|0.0001|2-Sided|95.0|3.0|7.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles|
1728061|NCT00570739|3184105|Superiority or Other||Mean Difference (Final Values)|5.99|||<|0.0001|2-Sided|95.0|3.51|8.48||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles|
1728062|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-0.85||||0.1622|2-Sided|95.0|-2.03|0.34||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles|
1728063|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-0.82||||0.1957|2-Sided|95.0|-2.06|0.42||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles|
1728064|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|0.19||||0.6554|2-Sided|95.0|-0.63|1.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles|
1728065|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|0.2||||0.6587|2-Sided|95.0|-0.68|1.07||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles|
1728066|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|0.56||||0.034|2-Sided|95.0|0.04|1.08||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles|
1728067|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|0.59||||0.0364|2-Sided|95.0|0.04|1.14||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles|
1728068|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.8615|2-Sided|95.0|-1.23|1.03||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles|
1728069|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.9807|2-Sided|95.0|-1.2|1.17||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles|
1728070|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-40.0||||0.3764|2-Sided|95.0|-129.0|49.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles|
1728071|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-42.0||||0.373|2-Sided|95.0|-134.8|50.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles|
1728072|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-6.7||||0.5528|2-Sided|95.0|-29.1|15.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles|
1728073|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-5.6||||0.6378|2-Sided|95.0|-29.1|17.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles|
1728074|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-46.9||||0.402|2-Sided|95.0|-157.1|63.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles|
1728075|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-47.7||||0.4143|2-Sided|95.0|-162.7|67.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles|
1728076|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-63.8||||0.0768|2-Sided|95.0|-134.6|6.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles|
1728077|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-63.6||||0.1007|2-Sided|95.0|-139.7|12.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles|
1728078|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-2.3||||0.7485|2-Sided|95.0|-16.5|11.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein (LDL) Particles|
1728079|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.9629|2-Sided|95.0|-15.2|14.5|||ANCOVA|||Intermediate Density Lipoprotein (LDL) Particles|
1728080|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-112.7||||0.0202|2-Sided|95.0|-207.6|-17.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles|
1728081|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-110.6||||0.0293|2-Sided|95.0|-209.9|-11.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles|
1728082|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-6.24||||0.0118|2-Sided|95.0|-11.09|-1.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles|
1728083|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|-7.49||||0.0044|2-Sided|95.0|-12.61|-2.37||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles|
1728084|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|5.24||||0.039|2-Sided|95.0|0.27|10.22||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Chylomicron Particles|
1728085|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|5.04||||0.0577|2-Sided|95.0|-0.17|10.24||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Chylomicron Particles|
1728086|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|2.39|||<|0.0001|2-Sided|95.0|1.27|3.51||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large VLDL Chylomicron Particles|
1728087|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|2.44|||<|0.0001|2-Sided|95.0|1.25|3.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large VLDL Chylomicron Particles|
1728088|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|1.53|||<|0.7157|2-Sided|95.0|-6.73|9.79||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total VLDL Particles|
1728089|NCT00570739|3184106|Superiority or Other||Mean Difference (Final Values)|0.09|||<|0.9838|2-Sided|95.0|-8.66|8.84||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total VLDL Particles|
1728090|NCT00570739|3184107|Superiority or Other||Median Difference (Final Values)|-4.38||||0.3934|2-Sided|95.0|-17.51|8.77||P-Value was from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks LOCF|
1728091|NCT00570739|3184107|Superiority or Other||Median Difference (Final Values)|-3.29||||0.6523|2-Sided|95.0|-17.5|10.32||P-Value was from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks|
1728092|NCT00570739|3184108|Superiority or Other||Median Difference (Final Values)|14.33||||0.0009|2-Sided|95.0|5.11|23.84||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks LOCF|
1728093|NCT00570739|3184108|Superiority or Other||Median Difference (Final Values)|16.07||||0.0011|2-Sided|95.0|6.33|26.02||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 16 Weeks|
1728094|NCT00570739|3184108|Superiority or Other||Median Difference (Final Values)|15.78||||0.0005|2-Sided|95.0|6.27|25.83||P-Value is from the non-parametric ANCOVA stratified by country|ANCOVA|Non-parametric|The median difference was calculated using Hodges-Lehmann point estimates and corresponding 95% confidence interval was constructed using the method of Moses.|Baseline to 8 Weeks|
1728095|NCT00570739|3184109|Superiority or Other||Mean Difference (Final Values)|10.45||||0.0918|2-Sided|95.0|-1.71|22.62||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a||Baseline to 16 Weeks LOCF|
1728096|NCT00570739|3184109|Superiority or Other||Mean Difference (Final Values)|11.58||||0.0901|2-Sided|95.0|-1.83|24.99||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728097|NCT00570739|3184109|Superiority or Other||Mean Difference (Final Values)|13.8||||0.0007|2-Sided|95.0|5.87|21.74||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks|
1728098|NCT00570739|3184110|Superiority or Other||Mean Difference (Final Values)|-8.09||||0.0004|2-Sided|95.0|-12.5|-3.68||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728336|NCT00568685|3184392|Superiority or Other|||||||0.4128||||||This is the p value for temperature change at endpoint|ANOVA||||
1728099|NCT00570739|3184110|Superiority or Other||Mean Difference (Final Values)|-8.67||||0.0004|2-Sided|95.0|-13.4|-3.94||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728100|NCT00570739|3184110|Superiority or Other||Mean Difference (Final Values)|-9.83|||<|0.0001|2-Sided|95.0|-13.68|-5.98||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks|
1728101|NCT00570739|3184111|Superiority or Other||Mean Difference (Final Values)|1.78||||0.2763|2-Sided|95.0|-1.44|4.99||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728102|NCT00570739|3184111|Superiority or Other||Mean Difference (Final Values)|2.13||||0.2238|2-Sided|95.0|-1.32|5.58||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728103|NCT00570739|3184111|Superiority or Other||Mean Difference (Final Values)|3.5||||0.0257|2-Sided|95.0|0.43|6.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks|
1728104|NCT00570739|3184112|Superiority or Other||Mean Difference (Final Values)|-7.23||||0.0002|2-Sided|95.0|-11.03|-3.44||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728105|NCT00570739|3184112|Superiority or Other||Mean Difference (Final Values)|-8.26|||<|0.0001|2-Sided|95.0|-12.25|-4.26||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728106|NCT00570739|3184112|Superiority or Other||Mean Difference (Final Values)|-8.91|||<|0.0001|2-Sided|95.0|-12.02|-5.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks|
1728107|NCT00570739|3184113|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.7972|2-Sided|95.0|-4.37|3.36||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728108|NCT00570739|3184113|Superiority or Other||Mean Difference (Final Values)|-0.85||||0.6878|2-Sided|95.0|-5.01|3.31||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728109|NCT00570739|3184113|Superiority or Other||Mean Difference (Final Values)|3.96||||0.0357|2-Sided|95.0|0.27|7.66||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks|
1728110|NCT00570739|3184114|Superiority or Other||Mean Difference (Final Values)|-9.06||||0.0002|2-Sided|95.0|-13.69|-4.42||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728111|NCT00570739|3184114|Superiority or Other||Mean Difference (Final Values)|-10.28|||<|0.0001|2-Sided|95.0|-15.15|-5.41||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728112|NCT00570739|3184114|Superiority or Other||Mean Difference (Final Values)|-12.47|||<|0.0001|2-Sided|95.0|-16.26|-8.69||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks|
1728113|NCT00570739|3184115|Superiority or Other||Mean Difference (Final Values)|-17.47|||<|0.0001|2-Sided|95.0|-23.24|-11.69||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728114|NCT00570739|3184115|Superiority or Other||Mean Difference (Final Values)|-19.62|||<|0.0001|2-Sided|95.0|-24.61|-14.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 8 Weeks|
1728115|NCT00570739|3184116|Superiority or Other|||||||0.4344|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728116|NCT00570739|3184116|Superiority or Other|||||||0.2874|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks|
1728117|NCT00570739|3184116|Superiority or Other||Odds Ratio (OR)|1.4||||0.9035|2-Sided|95.0|0.6|3.37||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF|
1728118|NCT00570739|3184116|Superiority or Other||Odds Ratio (OR)|1.64||||0.9008|2-Sided|95.0|0.66|4.06||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks|
1728119|NCT00570739|3184117|Superiority or Other|||||||0.317|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728120|NCT00570739|3184117|Superiority or Other|||||||0.5648|||||||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks|
1728121|NCT00570739|3184117|Superiority or Other||Odds Ratio (OR)|1.38||||0.5525|2-Sided|95.0|0.73|2.6||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks LOCF|
1728122|NCT00570739|3184117|Superiority or Other||Odds Ratio (OR)|1.21||||0.8804|2-Sided|95.0|0.63|2.34||P-Value for comparing percentages was from the Cochran-Mantel-Haenszel test stratified by country.|Cochran-Mantel-Haenszel|||Baseline to 16 Weeks|
1728153|NCT00570739|3184126|Superiority or Other||Odds Ratio (OR)|2.44||||0.0092|2-Sided|95.0|1.25|4.76|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728123|NCT00570739|3184118|Superiority or Other||Mean Difference (Final Values)|8.69||||0.0001|2-Sided|95.0|4.27|13.11||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated High Density Lipoprotein-Cholesterol|
1728124|NCT00570739|3184118|Superiority or Other||Mean Difference (Final Values)|8.35||||0.0005|2-Sided|95.0|3.71|13.0|||ANCOVA|||Calculated High Density Lipoprotein-Cholesterol|
1728125|NCT00570739|3184118|Superiority or Other||Mean Difference (Final Values)|24.72||||0.0013|2-Sided|95.0|9.71|39.73||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Very Low Density Lipoprotein Triglycerides|
1728126|NCT00570739|3184118|Superiority or Other||Mean Difference (Final Values)|22.79||||0.006|2-Sided|95.0|6.59|39.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Very Low Density Lipoprotein Triglycerides|
1728127|NCT00570739|3184118|Superiority or Other||Mean Difference (Final Values)|14.12||||0.0037|2-Sided|95.0|4.63|23.61||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Triglycerides|
1728128|NCT00570739|3184118|Superiority or Other||Mean Difference (Final Values)|12.81||||0.0144|2-Sided|95.0|2.57|23.05||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Calculated Triglycerides|
1728129|NCT00570739|3184119|Superiority or Other||Mean Difference (Final Values)|-11.54||||0.1997|2-Sided|95.0|-29.22|6.14||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728130|NCT00570739|3184119|Superiority or Other||Mean Difference (Final Values)|-10.46||||0.2289|2-Sided|95.0|-27.53|6.62||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728131|NCT00570739|3184120|Superiority or Other||Mean Difference (Final Values)|-15.59|||<|0.0001|2-Sided|95.0|-21.07|-10.11||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate.|||
1728132|NCT00570739|3184121|Superiority or Other||Mean Difference (Final Values)|-0.0035||||0.4039|2-Sided|95.0|-0.0118|0.0048||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728133|NCT00570739|3184121|Superiority or Other||Mean Difference (Final Values)|-0.0033||||0.4584|2-Sided|95.0|-0.0122|0.0055||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728134|NCT00570739|3184122|Superiority or Other||Mean Difference (Final Values)|0.15||||0.8371|2-Sided|95.0|-1.28|1.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728135|NCT00570739|3184122|Superiority or Other||Mean Difference (Final Values)|0.2||||0.7959|2-Sided|95.0|-1.32|1.72||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728136|NCT00570739|3184123|Superiority or Other||Odds Ratio (OR)|2.86||||0.00439|2-Sided|95.0|1.03|7.94|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF|
1728137|NCT00570739|3184123|Superiority or Other||Odds Ratio (OR)|2.49||||0.087|2-Sided|95.0|0.88|7.07|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks|
1728138|NCT00570739|3184123|Superiority or Other|||||||0.0157|||||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF|
1728139|NCT00570739|3184123|Superiority or Other|||||||0.0326|||||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks|
1728140|NCT00570739|3184123|Superiority or Other|||||||0.0004|||||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks|
1728141|NCT00570739|3184124|Superiority or Other||Odds Ratio (OR)|4.8|||<|0.0001|2-Sided|95.0|2.53|9.1|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728142|NCT00570739|3184124|Superiority or Other||Odds Ratio (OR)|5.59|||<|0.0001|2-Sided|95.0|2.78|11.23|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks|
1728143|NCT00570739|3184124|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF|
1728144|NCT00570739|3184124|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks|
1728145|NCT00570739|3184124|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks|
1728146|NCT00570739|3184125|Superiority or Other||Odds Ratio (OR)|2.08||||0.0088|2-Sided|95.0|1.2|3.6|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728147|NCT00570739|3184125|Superiority or Other||Odds Ratio (OR)|2.19||||0.0095|2-Sided|95.0|1.21|3.96|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks|
1728148|NCT00570739|3184125|Superiority or Other|||||||0.0589|||||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks LOCF|
1728149|NCT00570739|3184125|Superiority or Other|||||||0.084|||||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks|
1728150|NCT00570739|3184125|Superiority or Other|||||||0.0414|||||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 12 Weeks|
1728151|NCT00570739|3184125|Superiority or Other|||||||0.028|||||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 Weeks|
1728152|NCT00570739|3184125|Superiority or Other|||||||0.0008|||||||Cochran-Mantel-Haenszel|Startified by country||Baseline to 4 Weeks|
1728154|NCT00570739|3184126|Superiority or Other||Odds Ratio (OR)|2.9||||0.0049|2-Sided|95.0|1.38|6.1|||Regression, Logistic|Contained treatment and country as factors and baseline lab value as a covariate||Baseline to 16 Weeks|
1728155|NCT00570739|3184126|Superiority or Other|||||||0.0589|||||||Cochran-Mantel-Haenszel|Stratified by country.||Baseline to 16 Weeks LOCF|
1728156|NCT00570739|3184126|Superiority or Other|||||||0.0467|||||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 16 Weeks|
1728157|NCT00570739|3184126|Superiority or Other|||||||0.4957|||||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 12 Weeks|
1728158|NCT00570739|3184126|Superiority or Other|||||||0.8147|||||||Cochran-Mantel-Haenszel|Stratified by country||Baseline to 8 weeks|
1728159|NCT00570739|3184126|Superiority or Other|||||||0.5848|||||||Cochran-Mantel-Haenszel|Stratified by country.||Baseline to 4 Weeks|
1728160|NCT00570739|3184127|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.0035|2-Sided|95.0|-0.44|-0.09||P-Value is for the LS mean difference between the treatment groups|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.|||
1728161|NCT00570739|3184128|Superiority or Other||Mean Difference (Final Values)|2.8||||0.0008|2-Sided|95.0|1.2|4.4||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728162|NCT00570739|3184128|Superiority or Other||Mean Difference (Final Values)|2.6||||0.0033|2-Sided|95.0|0.9|4.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728163|NCT00570739|3184129|Superiority or Other||Mean Difference (Final Values)|30.7||||0.0002|2-Sided|95.0|14.9|46.6||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728164|NCT00570739|3184129|Superiority or Other||Mean Difference (Final Values)|29.8||||0.0008|2-Sided|95.0|12.5|47.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728165|NCT00570739|3184130|Superiority or Other||Mean Difference (Final Values)|27.2||||0.001|2-Sided|95.0|11.2|43.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks LOCF|
1728166|NCT00570739|3184130|Superiority or Other||Mean Difference (Final Values)|26.0||||0.0036|2-Sided|95.0|8.6|43.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 Weeks|
1728167|NCT00570739|3184131|Superiority or Other||Mean Difference (Final Values)|0.09||||0.0022|2-Sided|95.0|0.03|0.15||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles|
1728168|NCT00570739|3184131|Superiority or Other||Mean Difference (Final Values)|0.08||||0.0083|2-Sided|95.0|0.02|0.15||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||High Density Lipoprotein Particles|
1728169|NCT00570739|3184131|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.5715|2-Sided|95.0|-0.17|0.1||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotein Particles|
1728170|NCT00570739|3184131|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.4726|2-Sided|95.0|-0.2|0.09||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Low Density Lipoprotien Particles|
1728171|NCT00570739|3184131|Superiority or Other||Mean Difference (Final Values)|2.74||||0.0137|2-Sided|95.0|0.57|4.92||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles|
1728172|NCT00570739|3184131|Superiority or Other||Mean Difference (Final Values)|2.21||||0.0652|2-Sided|95.0|-0.14|4.57||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Low Density Lipoprotein Particles|
1728173|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.4762|2-Sided|95.0|-1.35|0.63||P-Value is for the LS Mean Difference between treatment group|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles|
1728174|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.5765|2-Sided|95.0|-1.34|0.75||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small HDL Particles|
1728175|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|0.85||||0.0187|2-Sided|95.0|0.14|1.56||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles|
1728176|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|0.69||||0.0693|2-Sided|95.0|-0.05|1.44||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium HDL Particles|
1728177|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|0.46||||0.0333|2-Sided|95.0|0.04|0.88||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles|
1728178|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|0.45||||0.0416|2-Sided|95.0|0.02|0.89||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large HDL Particles|
1728329|NCT00568776|3184382|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.39|Standard Error of the Mean|2.03||0.49|2-Sided|95.0|-5.41|2.62|||Mixed Models Analysis||||
1728179|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|1.01||||0.0301|2-Sided|95.0|0.1|1.91||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles|
1728180|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|0.94||||0.0524|2-Sided|95.0|-0.01|1.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total High Density Lipoprotein (HDL) Particles|
1728181|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-91.4||||0.0052|2-Sided|95.0|-155.2|-27.5||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles|
1728182|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-93.7||||0.0069|2-Sided|95.0|-161.6|-25.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Very Small LDL Particles|
1728183|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-15.4||||0.0997|2-Sided|95.0|-33.8|3.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles|
1728184|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-16.2||||0.102|2-Sided|95.0|-35.6|3.2||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium Small LDL Particles|
1728185|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-106.8||||0.0098|2-Sided|95.0|-187.6|-26.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles|
1728186|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-109.9||||0.0124|2-Sided|95.0|-195.8|-23.9||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small LDL Particles|
1728187|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-69.3||||0.0007|2-Sided|95.0|-109.2|-29.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles|
1728188|NCT00570739|3184132|Superiority or Other||Mean Difference (Net)|-77.7||||0.0004|2-Sided|95.0|-120.3|-35.0||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Large LDL Particles|
1728189|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-10.7||||0.057|2-Sided|95.0|-21.8|0.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein Particles|
1728190|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-11.7||||0.0466|2-Sided|95.0|-23.3|-0.2||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Intermediate Density Lipoprotein Particles|
1728191|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-186.1||||0.0001|2-Sided|95.0|-255.9|-116.3||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles|
1728192|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-199.3|||<|0.0001|2-Sided|95.0|-272.9|-125.8||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Low Density Lipoprotein (LDL) Particles|
1728193|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-3.23|||<|0.1007|2-Sided|95.0|-7.1|0.63||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles|
1728194|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|-2.88|||<|0.175|2-Sided|95.0|-7.04|1.29||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Small VLDL Particles|
1728195|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|7.13|||<|0.0003|2-Sided|95.0|3.35|10.91||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Particles|
1728196|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|7.13|||<|0.0006|2-Sided|95.0|3.1|11.21||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Medium VLDL Particles|
1728197|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|2.34|||<|0.001|2-Sided|95.0|0.96|3.73||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||VLDL Chylomicron Particles|
1728198|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|2.31|||<|0.0028|2-Sided|95.0|0.8|3.81||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||VLDL Chylomicron Particles|
1728199|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|6.39|||<|0.0347|2-Sided|95.0|0.46|12.31||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Very Low Density Lipoprotein (VLDL) Particles|
1728200|NCT00570739|3184132|Superiority or Other||Mean Difference (Final Values)|6.84|||<|0.0363|2-Sided|95.0|0.44|13.24||P-Value is for the LS Mean Difference between treatment groups|ANCOVA|The ANCOVA model includes treatment and country as fixed effects and baseline lab value as a covariate||Total Very Low Density Lipoprotein (VLDL) Particles|
1728201|NCT00570739|3184133|Superiority or Other||Mean Difference (Final Values)|15.08|||<|0.0001|2-Sided|95.0|7.95|22.2|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF|
1728202|NCT00570739|3184133|Superiority or Other||Mean Difference (Final Values)|14.52|||<|0.0003|2-Sided|95.0|6.64|22.4|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks|
1728203|NCT00570739|3184133|Superiority or Other||Mean Difference (Final Values)|12.57|||<|0.0003|2-Sided|95.0|5.76|19.38|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks|
1728204|NCT00570739|3184134|Superiority or Other||Mean Difference (Final Values)|-7.97|||<|0.0001|2-Sided|95.0|-11.35|-4.59|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF|
1728205|NCT00570739|3184134|Superiority or Other||Mean Difference (Final Values)|-9.53|||<|0.0001|2-Sided|95.0|-13.14|-5.92|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks|
1728206|NCT00570739|3184134|Superiority or Other||Mean Difference (Final Values)|-11.56|||<|0.0001|2-Sided|95.0|-14.74|-8.38|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks|
1728207|NCT00570739|3184135|Superiority or Other||Mean Difference (Final Values)|4.43||||0.0009|2-Sided|95.0|1.83|7.03|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF|
1728208|NCT00570739|3184135|Superiority or Other||Mean Difference (Final Values)|3.65||||0.0117|2-Sided|95.0|0.82|6.47|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks|
1728209|NCT00570739|3184135|Superiority or Other||Mean Difference (Final Values)|2.81||||0.0496|2-Sided|95.0|0.0|5.62|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 weeks|
1728210|NCT00570739|3184136|Superiority or Other||Mean Difference (Final Values)|18.62|||<|0.0001|2-Sided|95.0|11.18|25.74||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 16 Weeks LOCF|
1728211|NCT00570739|3184136|Superiority or Other||Mean Difference (Final Values)|17.71|||<|0.0001|2-Sided|95.0|9.66|25.54||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 16 Weeks|
1728212|NCT00570739|3184136|Superiority or Other||Mean Difference (Final Values)|7.05|||<|0.0171|2-Sided|95.0|-0.33|13.99||The P-Value was from the non-parametric ANCOVA stratified by country.|ANCOVA|The median difference was calculated using Hodges-Lehmann point estimate and corresponding 95% CI was constructed using the method of Moses.||Baseline to 8 weeks|
1728213|NCT00570739|3184137|Superiority or Other||Mean Difference (Final Values)|-6.09||||0.0001|2-Sided|95.0|-9.14|-3.05|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF|
1728214|NCT00570739|3184137|Superiority or Other||Mean Difference (Final Values)|-6.94|||<|0.0001|2-Sided|95.0|-10.23|-3.66|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks|
1728215|NCT00570739|3184137|Superiority or Other||Mean Difference (Final Values)|-8.81|||<|0.0001|2-Sided|95.0|-11.53|-6.08|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks|
1728216|NCT00570739|3184138|Superiority or Other||Mean Difference (Final Values)|1.81||||0.2609|2-Sided|95.0|-1.35|4.97|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF|
1728217|NCT00570739|3184138|Superiority or Other||Mean Difference (Final Values)|1.32||||0.4506|2-Sided|95.0|-2.12|4.75|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks|
1728218|NCT00570739|3184138|Superiority or Other||Median Difference (Final Values)|2.63||||0.2026|2-Sided|95.0|-1.43|6.7|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks|
1728219|NCT00570739|3184139|Superiority or Other||Mean Difference (Final Values)|-8.33|||<|0.0001|2-Sided|95.0|-11.98|-4.67|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Week LOCF|
1728220|NCT00570739|3184139|Superiority or Other||Mean Difference (Final Values)|-9.28|||<|0.0001|2-Sided|95.0|-13.23|-5.34|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks|
1728221|NCT00570739|3184139|Superiority or Other||Mean Difference (Final Values)|-12.4|||<|0.0001|2-Sided|95.0|-15.99|-8.81|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks|
1728222|NCT00570739|3184140|Superiority or Other||Mean Difference (Final Values)|-16.33|||<|0.0001|2-Sided|95.0|-20.96|-11.69|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF|
1728223|NCT00570739|3184140|Superiority or Other||Mean Difference (Final Values)|-17.08|||<|0.0001|2-Sided|95.0|-22.09|-12.08|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks|
1728224|NCT00570739|3184140|Superiority or Other||Mean Difference (Final Values)|-18.19|||<|0.0001|2-Sided|95.0|-22.61|-13.76|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks|
1728225|NCT00570739|3184141|Superiority or Other||Mean Difference (Final Values)|0.07||||0.8319|2-Sided|95.0|-0.581|0.722||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF|
1728330|NCT00568776|3184383|Superiority or Other (legacy)||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.11||0.17|2-Sided|95.0|-0.06|0.36|||Mixed Models Analysis||||
1728226|NCT00570739|3184141|Superiority or Other||Mean Difference (Final Values)|0.215||||0.5161|2-Sided|95.0|-0.437|0.867||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks|
1728227|NCT00570739|3184142|Superiority or Other||Mean Difference (Final Values)|-1.565||||0.7433|2-Sided|95.0|-10.966|7.836||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF|
1728228|NCT00570739|3184142|Superiority or Other||Mean Difference (Final Values)|1.051||||0.8158|2-Sided|95.0|-7.828|9.929||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks|
1728229|NCT00570739|3184143|Superiority or Other||Mean Difference (Final Values)|-6.6||||0.2524|2-Sided|95.0|-17.9|4.7||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF|
1728230|NCT00570739|3184143|Superiority or Other||Mean Difference (Final Values)|-5.1||||0.3663|2-Sided|95.0|-16.1|6.0||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks|
1728231|NCT00570739|3184144|Superiority or Other||Mean Difference (Final Values)|-7.7||||0.1583|2-Sided|95.0|-18.3|3.0||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 Weeks LOCF|
1728232|NCT00570739|3184144|Superiority or Other||Mean Difference (Final Values)|-7.0||||0.195|2-Sided|95.0|-17.5|3.6||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks|
1728233|NCT00570739|3184145|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.8203|2-Sided|95.0|-10.5|8.3||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks LOCF|
1728234|NCT00570739|3184145|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9933|2-Sided|95.0|-9.3|9.4||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks|
1728235|NCT00570739|3184146|Superiority or Other||Mean Difference (Final Values)|-0.141||||0.1146|2-Sided|95.0|-0.317|0.035||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)|
1728236|NCT00570739|3184146|Superiority or Other||Mean Difference (Final Values)|-0.153||||0.1078|2-Sided|95.0|-0.34|0.034||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate||Baseline to 16 weeks|
1728237|NCT00570739|3184147|Superiority or Other||Mean Difference (Final Values)|0.21||||0.8196|2-Sided|95.0|-1.599|2.019||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)|
1728238|NCT00570739|3184147|Superiority or Other||Mean Difference (Final Values)|0.176||||0.861|2-Sided|95.0|-1.805|2.158||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks|
1728239|NCT00570739|3184147|Superiority or Other||Mean Difference (Final Values)|-1.504||||0.0332|2-Sided|95.0|-2.887|-0.121||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks|
1728240|NCT00570739|3184147|Superiority or Other||Mean Difference (Final Values)|-1.015||||0.1782|2-Sided|95.0|-2.477|0.447||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 weeks|
1728241|NCT00570739|3184147|Superiority or Other||Mean Difference (Final Values)|-0.303||||0.7606|2-Sided|95.0|-2.259|1.653||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 weeks|
1728242|NCT00570739|3184148|Superiority or Other||Mean Difference (Final Values)|-2.1||||0.4909|2-Sided|95.0|-8.0|3.9|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks (LOCF)|
1728243|NCT00570739|3184148|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.4063|2-Sided|95.0|-8.4|3.4|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks|
1728244|NCT00570739|3184148|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.7269|2-Sided|95.0|-7.0|4.9|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks|
1728245|NCT00570739|3184148|Superiority or Other||Mean Difference (Final Values)|-3.3||||0.2167|2-Sided|95.0|-8.6|2.0|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks|
1728246|NCT00570739|3184148|Superiority or Other||Mean Difference (Final Values)|-5.1||||0.1112|2-Sided|95.0|-11.3|1.2|||ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 Weeks|
1728247|NCT00570739|3184149|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.0046|2-Sided|95.0|-0.42|-0.08||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 16 weeks|
1728248|NCT00570739|3184149|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.0239|2-Sided|95.0|-0.36|-0.03||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 12 weeks|
1728331|NCT00568776|3184384|Superiority or Other (legacy)||Mean Difference (Final Values)|-2.56|Standard Error of the Mean|1.9||0.18|2-Sided|95.0|-6.33|1.22|||Mixed Models Analysis||||
1728249|NCT00570739|3184149|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.0201|2-Sided|95.0|-0.33|-0.03||P-Value is for the LS Mean Difference between treatment groups.|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 8 Weeks|
1728250|NCT00570739|3184149|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.0123|2-Sided|95.0|-0.27|-0.03||P-Value is for the LS mean difference between treatment groups|ANCOVA|The Ancova model includes treatment and country as fixed effects and baseline lab value as a covariate.||Baseline to 4 weeks|
1728251|NCT00570674|3184159|Other|||||||0.39|||||||Sign test||||
1728252|NCT00570674|3184160|Other|||||||0.52|||||||Sign test||||
1728253|NCT00570674|3184161|Other||||||<|0.01|||||||Sign test||||
1728254|NCT00570674|3184162|Other||||||<|0.01|||||||Sign test||||
1728255|NCT00570492|3184196|Superiority or Other||Mean Difference (Final Values)|-0.27|||||2-Sided|95.0|-0.48|-0.06|||||An analysis of covariance (ANCOVA) was performed to estimate the mean treatment difference in growth velocity over the treatment period, adjusting for baseline growth velocity, age, gender, and country.||
1728256|NCT00570323|3184204|Superiority|||||||0.6202|||||||t-test, 2 sided||||
1728257|NCT00570310|3184205|Superiority or Other||Mean Difference (Final Values)|7.67|||<|0.001||95.0|5.26|10.08||1-sided, alpha = 0.05|ANOVA||||
1728258|NCT00570310|3184206|Superiority or Other||Mean Difference (Final Values)|-1.42||||0.003||90.0|-2.25|-0.6||1-sided, alpha = 0.05|ANOVA||Primary Hypothesis: In ’primary responder population', pregabalin is superior to placebo in maintaining pain control measured by change (3-day average: end of the randomization period versus end of maintenance period) in evening pain intensity.||
1728259|NCT00570063|3184219|Superiority or Other||Mean Difference (Net)|0.1|Standard Deviation|1.133|||2-Sided|90.0|-1.763|1.963||||||Change at Day 21|
1728260|NCT00570063|3184219|Superiority or Other||Mean Difference (Net)|0.436|Standard Deviation|1.448|||2-Sided|90.0|-1.946|2.817||||||Change at Day 14|
1728261|NCT00570063|3184219|Superiority or Other||Mean Difference (Net)|0.327|Standard Deviation|1.349|||2-Sided|90.0|-1.892|2.547||||||Change at Day 7|
1728262|NCT00570063|3184219|Superiority or Other||Mean Difference (Net)|-0.291|Standard Deviation|1.203|||2-Sided|90.0|-2.27|1.688||||||Change at Day 4|
1728263|NCT00570063|3184220|Superiority or Other||Mean Difference (Net)|0.705|Standard Deviation|1.652|||2-Sided|90.0|-2.013|3.422||||||Change at Day 21: Akathisia|
1728264|NCT00570063|3184220|Superiority or Other||Mean Difference (Net)|-0.932|Standard Deviation|1.425|||2-Sided|90.0|-3.275|1.411||||||Change at Day 21: Dystonia|
1728265|NCT00570063|3184220|Superiority or Other||Mean Difference (Net)|-0.182|Standard Deviation|3.008|||2-Sided|90.0|-5.13|4.766||||||Change at Day 21: Dyskinesia|
1728266|NCT00570063|3184220|Superiority or Other||Mean Difference (Net)|-0.273|Standard Deviation|3.488|||2-Sided|90.0|-6.01|5.465||||||Change at Day 21: Parkinsonism|
1728267|NCT00570063|3184221|Superiority or Other||Mean Difference (Net)|-4.195|Standard Deviation|9.307|||2-Sided|90.0|-19.5|11.114|||||||
1728268|NCT00570063|3184222|Superiority or Other||Mean Difference (Net)|-0.849|Standard Deviation|4.23|||2-Sided|90.0|-7.807|6.109|||||||
1728269|NCT00570063|3184232|Superiority or Other||Mean Difference (Net)|5.712|Standard Deviation|12.24|||2-Sided|90.0|-14.42|25.845|||||||
1728270|NCT00570063|3184233|Superiority or Other||Mean Difference (Net)|-0.62|Standard Deviation|4.447|||2-Sided|90.0|-7.934|6.694||||||Change at Day 21: Social interest|
1728271|NCT00570063|3184233|Superiority or Other||Mean Difference (Net)|-0.561|Standard Deviation|2.63|||2-Sided|90.0|-4.887|3.764||||||Change at Day 21: Social competence|
1728272|NCT00570063|3184233|Superiority or Other||Mean Difference (Net)|-0.17|Standard Deviation|0.572|||2-Sided|90.0|-1.11|0.771||||||Change at Day 21: Said he/she was no good|
1728273|NCT00570063|3184233|Superiority or Other||Mean Difference (Net)|-0.632|Standard Deviation|2.749|||2-Sided|90.0|-5.152|3.889||||||Change at Day 21: Retardation|
1728274|NCT00570063|3184233|Superiority or Other||Mean Difference (Net)|-0.327|Standard Deviation|0.532|||2-Sided|90.0|-1.202|0.547||||||Change at Day 21: Refused to speak|
1728275|NCT00570063|3184233|Superiority or Other||Mean Difference (Net)|0.556|Standard Deviation|2.096|||2-Sided|90.0|-2.892|4.003||||||Change at Day 21: Personal neatness|
1728276|NCT00570063|3184233|Superiority or Other||Mean Difference (Net)|0.573|Standard Deviation|2.955|||2-Sided|90.0|-4.287|5.433||||||Change at Day 21: Manifest psychosis|
1728277|NCT00570063|3184233|Superiority or Other||Mean Difference (Net)|1.544|Standard Deviation|4.32|||2-Sided|90.0|-5.561|8.649||||||Change at Day 21: Irritability|
1728278|NCT00570063|3184233|Superiority or Other||Mean Difference (Net)|0.444|Standard Deviation|1.078|||2-Sided|90.0|-1.329|2.218||||||Change at Day 21: Felt blue or depressed|
1728279|NCT00570063|3184233|Superiority or Other||Median Difference (Net)|-0.158|Standard Deviation|0.844|||2-Sided|90.0|-1.546|1.231||||||Change at Day 21: Cried|
1728280|NCT00570063|3184234|Superiority or Other||LS mean difference|0.01|Standard Error of the Mean|0.68||0.99|2-Sided|90.0|-1.13|1.14|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP[POW]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects.|
1728281|NCT00570063|3184235|Superiority or Other||LS mean difference|-0.04|Standard Error of the Mean|0.48||0.93|2-Sided|90.0|-0.84|0.76|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP[POW]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|
1728282|NCT00570063|3184236|Superiority or Other||LS mean difference|0.44|Standard Error of the Mean|1.86||0.81|2-Sided|90.0|-2.65|3.53|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP[POW]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|
1728283|NCT00570063|3184237|Superiority or Other||LS mean difference|0.84|Standard Error of the Mean|1.62||0.6|2-Sided|90.0|-1.85|3.54|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP[POW]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|
1728284|NCT00570063|3184238|Superiority or Other||LS mean difference|0.14|Standard Error of the Mean|1.35||0.92|2-Sided|90.0|-2.11|2.39|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP[POW]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|
1728285|NCT00570063|3184239|Superiority or Other||LS mean difference|0.63|Standard Error of the Mean|2.29||0.78|2-Sided|90.0|-3.17|4.43|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP[POW]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|
1728286|NCT00570063|3184240|Superiority or Other||LS mean difference|-0.3|Standard Error of the Mean|2.68||0.91|2-Sided|90.0|-4.76|4.16|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP[POW]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|
1728287|NCT00570063|3184241|Superiority or Other||LS mean difference|-2.57|Standard Error of the Mean|3.22||0.43|2-Sided|90.0|-7.92|2.79|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP[POW]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|
1728288|NCT00570063|3184242|Superiority or Other||LS mean difference|0.74|Standard Error of the Mean|4.18||0.86|2-Sided|90.0|-6.21|7.69|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP[POW]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|
1728289|NCT00570063|3184243|Superiority or Other||LS mean difference|-0.24|Standard Error of the Mean|2.61||0.93|2-Sided|90.0|-4.59|4.1|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP[POW]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|
1728290|NCT00570063|3184244|Superiority or Other||LS mean difference|-1.23|Standard Error of the Mean|2.69||0.65|2-Sided|90.0|-5.71|3.24|||Mixed Models Analysis|||P-value and 90 percent CI were obtained from mixed effects repeated measures analysis using covariance structures (SP[POW]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|
1728291|NCT00570063|3184245|Superiority or Other||Least square (LS) mean difference|-1.61|Standard Error of the Mean|8.94||0.86|2-Sided|90.0|-16.49|13.27|||Mixed Models Analysis|||P-value and 90 percent confidence interval (CI) were obtained from mixed effects repeated measures analysis using covariance structures spatial power covariance structure (SP[POW]) with participant as random effect, treatment, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|
1728292|NCT00569803|3184272|Superiority or Other||Ratio of Geometric Means|0.9|||||2-Sided|90.0|0.75|1.07|||||AUC(INF) Ratio of Geometric Means: 1 injection site over 2 injection sites||
1728293|NCT00569803|3184272|Superiority or Other||Ratio of Geometric Means|0.9|||||2-Sided|90.0|0.75|1.07|||||AUC(0-T) Ratio of Geometric Means: 1 injection site over 2 injection sites||
1728294|NCT00569803|3184278|Superiority or Other||Ratio of Geometric Means|0.73|||||2-Sided|90.0|0.57|0.92|||||Ratio of Geometric Means: 250mg SC over 125mg IV||
1728295|NCT00569803|3184278|Superiority or Other||Ratio of Geometric Means|0.88|||||2-Sided|90.0|0.69|1.12|||||Ratio of Geometric Means: 200mg SC over 125mg IV||
1728296|NCT00569803|3184278|Superiority or Other||Ratio of Geometric Means|0.9|||||2-Sided|90.0|0.71|1.14|||||Ratio of Geometric Means: 150mg SC over 125mg IV||
1728297|NCT00569803|3184278|Superiority or Other||Ratio of Geometric Means|0.79|||||2-Sided|90.0|0.62|1.0|||||Ratio of Geometric Means: 125mg SC over 125mg IV||
1728298|NCT00569803|3184278|Superiority or Other||Ratio of Geometric Means|0.61|||||2-Sided|90.0|0.48|0.77|||||Ratio of Geometric Means: 100mg SC over 125mg IV||
1728299|NCT00569803|3184278|Superiority or Other||Ratio of Geometric Means|0.87|||||2-Sided|90.0|0.69|1.1|||||Ratio of Geometric Means: 50mg SC over 125mg IV||
1728300|NCT00569803|3184279|Superiority or Other||Ratio of Geometric Means|0.73|||||2-Sided|90.0|0.57|0.92|||||Ratio of Geometric Means: 250mg SC over 125mg IV||
1728301|NCT00569803|3184279|Superiority or Other||Ratio of Geometric Means|0.88|||||2-Sided|90.0|0.69|1.11|||||Ratio of Geometric Means: 200mg SC over 125mg IV||
1728302|NCT00569803|3184279|Superiority or Other||Ratio of Geometric Means|0.89|||||2-Sided|90.0|0.71|1.13|||||Ratio of Geometric Means: 150mg SC over 125mg IV||
1728303|NCT00569803|3184279|Superiority or Other||Ratio of Geometric Means|0.78|||||2-Sided|90.0|0.62|0.99|||||Ratio of Geometric Means: 125mg SC over 125mg IV||
1728304|NCT00569803|3184279|Superiority or Other||Ratio of Geometric Means|0.61|||||2-Sided|90.0|0.48|0.77|||||Ratio of Geometric Means: 100mg SC over 125mg IV||
1728305|NCT00569803|3184279|Superiority or Other||Ratio of Geometric Means|0.86|||||2-Sided|90.0|0.68|1.08|||||Ratio of Geometric Means: 50mg SC over 125mg IV||
1728306|NCT00569270|3184322|Superiority or Other|||||||0.36||||||A priori threshold for statistical significance: p= 0.05|Spearman rho|Spearman rho = -0.26||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema|
1728307|NCT00569270|3184323|Superiority or Other||||||>|0.05||||||Total lung capacity was similar in all groups and was not significant|Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728308|NCT00569270|3184324|Superiority or Other|||||||0.0001||||||A priori threshold for statistical significance: p<0.05|Mixed Models Analysis|||Change in IC before and after dynamic hyperinflation. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728332|NCT00568776|3184385|Superiority or Other (legacy)||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.09||0.71|2-Sided|95.0|-0.14|0.21|||Mixed Models Analysis||||
1728309|NCT00569270|3184325|Superiority or Other|||||||-0.13||||||A priori threshold for statistical significance: p<0.05|Mixed Models Analysis|||Mean difference of Trough TLC (L) of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728310|NCT00569270|3184326|Superiority or Other|||||||-0.02||||||A priori threshold for statistical significance: p<0.05|Mixed Models Analysis|||Mean difference of Trough FRC/TLC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728311|NCT00569270|3184327|Superiority or Other|||||||0.922||||||A priori threshold for statistical significance: p<0.05|Mixed Models Analysis|||Mean difference of Trough IC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728312|NCT00569270|3184328|Superiority or Other|||||||0.589||||||A priori threshold for statistical significance: p<0.05|Mixed Models Analysis|||Mean difference of trough FVC in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728313|NCT00569270|3184329|Superiority or Other|||||||0.068||||||A priori threshold for statistical significance: p<0.05|Mixed Models Analysis|||Mean difference of Trough FRC(L) in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728314|NCT00569270|3184330|Superiority or Other|||||||0.345|||||||Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728315|NCT00569270|3184331|Superiority or Other|||||||0.325||||||Statistical significance was p<0.05|Mixed Models Analysis|||29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728316|NCT00569270|3184332|Superiority or Other|||||||0.615||||||A priori threshold for statistical significance: p<0.05|Regression, Logistic|||Mean difference of Peak FRC/TLC of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728317|NCT00569270|3184333|Superiority or Other|||||||0.067||||||A priori threshold for statistical significance: p<0.05|Mixed Models Analysis|||Mean difference of Peak IC of tiotropium minus placebo.29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728318|NCT00569270|3184334|Superiority or Other||Spearman rho|-0.26||||0.4||95.0|||||Spearman rho|||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema (19 patients); measures include change in IC at trough tiotropium.|
1728319|NCT00569270|3184335|Superiority or Other|||||||0.078||||||Statistical significance was p < 0.05|Mixed Models Analysis|||Mean difference of Peak FVC of tiotropium minus placebo.29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728320|NCT00569270|3184336|Superiority or Other|||||||0.318||||||A priori threshold for statistical significance: p<0.05|Mixed Models Analysis|||Mean difference of Peak FRC in tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728321|NCT00569270|3184337|Superiority or Other||Spearman rho|0.19||||0.96||95.0||||A priori threshold for statistical significance: p=0.05|Spearman rho|||Correlation between improved lung function after tiotropium and extent of lung CT scored emphysema with respect to ratio functional residual capacity divided by total lung capacity. Specifically, correlation of tiotropium induced bronchodilation and extent of lung ct scored emphysema; measure includes change in FEV1 post tiotropium|
1728322|NCT00569270|3184338|Superiority or Other|||||||0.027||||||a priori threshold for statistical significance: p<0.05|Mixed Models Analysis|||Mean difference of Peak FEV1 of tiotropium minus placebo. 29 patients needed to achieve a power of 80% at a significant alpha level of 5% using projected sample inspiratory capacity of 2.23+/- 0.5L post tiotropium compared to baseline inspiratory capacity 2.0+/-0.5L|
1728323|NCT00569166|3184357|Superiority or Other|||||||0.4715|||||||Wilcoxon rank-sum|||Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.|
1728324|NCT00569166|3184357|Superiority or Other|||||||0.3679|||||||Wilcoxon rank-sum|||Treatment effectiveness was measured using pairwise comparisons of hot flash score change from baseline in each paced breathing arm.|
1728325|NCT00569127|3184362|Superiority or Other (legacy)||Hazard Ratio (HR)|0.93||||0.55|2-Sided|95.0|0.73|1.18||Central-review based progression-free survival was analyzed using the stratified log rank test (which is the score test from the stratified Cox-model) using stratification factors as defined in Section 6.0.|Regression, Cox||The reported hazard ratio estimate is for the comparison of the Octreotide, Bevacizumab arm to the Octreotide, Interferon Alpha-2b arm.|According to the intent-to-treat principle, all eligible patients were included in the analysis according to the randomized treatment assignment, regardless of actual treatments received.|
1728326|NCT00568776|3184379|Superiority or Other (legacy)||Mean Difference (Final Values)|1.02|Standard Error of the Mean|2.24||0.65|2-Sided|95.0|-3.43|5.46|||Mixed Models Analysis||||
1728327|NCT00568776|3184380|Superiority or Other (legacy)||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.47||0.54|2-Sided|95.0|-0.63|1.21|||Mixed Models Analysis||||
1728328|NCT00568776|3184381|Superiority or Other (legacy)||Mean Difference (Final Values)|0.65|Standard Error of the Mean|2.2||0.77|2-Sided|95.0|-3.73|5.03|||Mixed Models Analysis||||
1728337|NCT00568685|3184393|Superiority or Other|||||||0.8005||||||This is the p value for heart rate change at endpoint|ANOVA||||
1728338|NCT00568685|3184395|Superiority or Other|||||||0.024|||||||ANCOVA||||
1728339|NCT00568685|3184396|Superiority or Other|||||||0.45||||||P-value relates to the sum of adverse events leading to discontinuation.|Fisher Exact||||
1728340|NCT00568685|3184397|Superiority or Other|||||||0.0153||||||This is the p value for CGI-ADHD-I score change at endpoint|Mixed Models Analysis||||
1728341|NCT00568685|3184398|Superiority or Other|||||||0.0048||||||This is the p value for CGI-ADHD-S score change at endpoint|Mixed Models Analysis||||
1728342|NCT00568451|3184416|Superiority or Other||Median|12.5|||||1-Sided|95.0|4.5||||||||
1728343|NCT00568399|3184419|Superiority or Other||Mean Difference (Final Values)|9.2|Standard Deviation|0.987||0.001|2-Sided|95.0||||Coronary calcium score after treatment compared to baseline|Wilcoxon (Mann-Whitney)|||This was a pilot study without a control group. There were no power calculations (see manuscript).|
1728344|NCT00568334|3184429|Non-Inferiority|The lower limit (LL) of the 95% confidence interval (CI) for the GMC ratio (derived from ELISA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.67.|GMC Ratio|1.12|||||2-Sided|95.0|0.93|1.33||||||Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean concentrations (GMCs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.|
1728345|NCT00568334|3184430|Non-Inferiority|The lower limit (LL) of the 95% confidence interval (CI) for the GMT ratio (derived from IFA) between Group Varilrix HSA-Free and (divided by) Group Varilrix is equal to or above (≥) the pre-defined clinical limit of 0.5.|GMT Ratio|1.12|||||2-Sided|95.0|0.86|1.46||||||Non-inferiority of Varilrix™ HSA-Free vaccine as compared to Varilrix™ vaccine in terms of geometric mean titers (GMTs) of varicella zoster virus (VZV) antibodies 43-57 days after the first vaccine dose.|
1728346|NCT00568178|3184431|Superiority or Other||Least Square Mean|-3.8||||||95.0|-15.2|7.6|||||||
1728347|NCT00568178|3184432|Superiority or Other||Geometric Mean Ratio|1.18|||||2-Sided|95.0|0.86|1.6|||||||
1728348|NCT00568178|3184433|Superiority or Other||Mean Difference (Final Values)|-4.6||||||95.0|-9.2|-0.1|||||||
1728349|NCT00568178|3184434|Superiority or Other||Mean Difference (Final Values)|-5.4||||||95.0|-9.9|-1.0|||||||
1728350|NCT00568178|3184435|Superiority or Other||Ratio in Geometric Mean|0.63||||0.001|2-Sided|95.0|0.54|0.74|||Mixed Models Analysis||||
1728351|NCT00567892|3184464|Superiority or Other||Median Difference (Net)|-4.0||||0.674|2-Sided|95.0|-9.0|10.0|||Wilcoxon signed rank test|The assumptions of parametric tests were not met.|All statistical tests were two-sided and were evaluated at the α = 0.05 level of significance.|The null hypothesis for this study was the difference between the change in THI score due to 4 weeks active rTMS treatment and the change in THI score due to 4 weeks rTMS sham was not different from 0.|
1728352|NCT00567892|3184464|Superiority or Other||Median Difference (Net)|0.0||||0.944|2-Sided|95.0|-6.0|4.0||All statistical tests were two-sided and were evaluated at the α = 0.05 level of significance.|Wilcoxon signed rank test|Since the assumptions of parametric tests were not met we used non-parametric tests for the analysis.||The null hypothesis for this study was the difference between the change in THI score due to active rTMS treatment and the change in THI score due to rTMS sham was not different from 0.|
1728353|NCT00567593|3184473|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum test|||
1728354|NCT00567567|3184481|Superiority or Other (legacy)||Hazard Ratio (HR)|1.015||||0.6853|2-Sided|95.0|||||Regression, Cox|||The relationship between the peak serum isotretinoin concentration level with event-free survival was explored with a Cox proportional hazards model. Eligible patients treated with isotretinoin on A3973, ANBL0032, ANBL0532, or ANBL0931 with peak serum concentration level data were included in the analysis.|
1728355|NCT00567567|3184485|Superiority or Other (legacy)||Odds Ratio (OR)|1.4328||||0.7598|2-Sided|95.0|0.4105|5.001|||Fisher Exact|Fisher's exact test was used instead of chi-square test due to small expected cell counts.||Null Hypothesis: The response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population|
1728356|NCT00567567|3184486|Superiority or Other (legacy)||Slope|0.0543||||0.3277|2-Sided|95.0|||||Regression, Logistic||||
1728357|NCT00567567|3184487|Superiority or Other (legacy)||Slope|-0.0557||||0.0939|2-Sided|95.0|||||Regression, Logistic||||
1728358|NCT00567567|3184488|Superiority or Other (legacy)||Gray's test statistic|0.33709||||0.5615|2-Sided|95.0|||||Gray's test for competing risks|||The cumulative incidence rates of local recurrence between patients from ANBL0532 randomized or assigned to receive single CEM transplant and boost radiation and A3973 patients who were transplanted and received boost radiation were compared using Gray's test.|
1728359|NCT00567567|3184489|Superiority or Other (legacy)||Chi-squared test statistic|8.5751||||0.0034|2-Sided|95.0|||||Chi-squared|||Chi-square test of proportions in all patients to compare the proportion of responders (complete response [CR]+ very good partial response [VGPR]) at the end of induction therapy in this study to an analogous cohort of responders in A3973.|
1728360|NCT00567567|3184490|Superiority or Other (legacy)||Log Rank Test Statistic|6.9883||||0.0082|2-Sided|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - Single HST (CEM) and randomized to Regimen B - Tandem HST (CEM) were compared using the log-rank test.|
1728361|NCT00567489|3184498|Superiority||Mean Difference (Final Values)|-0.2||||0.955|2-Sided|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6|
1728362|NCT00567489|3184499|Superiority||Mean Difference (Final Values)|2.4||||0.82|2-Sided|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6|
1728363|NCT00567489|3184499|Superiority||Mean Difference (Final Values)|2.3||||0.832|2-Sided|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6|
1728364|NCT00567489|3184500|Superiority||Mean Difference (Final Values)|7.8||||0.486|2-Sided|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6|
1728365|NCT00567489|3184500|Superiority||Mean Difference (Final Values)|6.3||||0.626|2-Sided|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6|
1728366|NCT00567489|3184501|Superiority||Mean Difference (Final Values)|55.4||||0.081|2-Sided|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6|
1728367|NCT00567489|3184501|Superiority||Mean Difference (Final Values)|24.6||||0.495|2-Sided|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6|
1728368|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|2.38||||0.34|2-Sided|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6|
1728369|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|-0.09||||0.97|2-Sided|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3|
1728370|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|-0.33||||0.906|2-Sided|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6|
1728371|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|-1.5||||0.586|2-Sided|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3|
1728372|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|1.62||||0.641|2-Sided|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6|
1728373|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|1.89||||0.585|2-Sided|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3|
1728374|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|3.13||||0.209|2-Sided|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6|
1728375|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|0.2||||0.934|2-Sided|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3|
1728376|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|7.21||||0.01|2-Sided|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6|
1728377|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|1.07||||0.701|2-Sided|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3|
1728378|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|4.41||||0.128|2-Sided|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6|
1728379|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|0.41||||0.885|2-Sided|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3|
1728380|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|-0.72||||0.78|2-Sided|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6|
1728381|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|-2.95||||0.246|2-Sided|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3|
1728382|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|0.83||||0.779|2-Sided|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6|
1728383|NCT00567489|3184502|Superiority||Mean Difference (Final Values)|-1.87||||0.526|2-Sided|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3|
1728384|NCT00567489|3184503|Superiority||Mean Difference (Final Values)|0.02||||0.995|2-Sided|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6|
1728385|NCT00567489|3184503|Superiority||Mean Difference (Final Values)|2.18||||0.525|2-Sided|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3|
1728386|NCT00567489|3184504|Superiority||Mean Difference (Final Values)|-0.02||||0.485|2-Sided|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6|
1728387|NCT00567489|3184504|Superiority||Mean Difference (Final Values)|0.02||||0.412|2-Sided|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3|
1728388|NCT00567489|3184505|Superiority||Mean Difference (Final Values)|-18.3||||0.854|2-Sided|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6|
1728389|NCT00567489|3184505|Superiority||Mean Difference (Final Values)|185.3||||0.377|2-Sided|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3|
1728390|NCT00567489|3184505|Superiority||Mean Difference (Final Values)|-1.7||||0.731|2-Sided|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6|
1728391|NCT00567489|3184505|Superiority||Mean Difference (Final Values)|5.2||||0.608|2-Sided|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3|
1728392|NCT00567489|3184506|Superiority||Mean Difference (Final Values)|-0.3||||0.871|2-Sided|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6|
1728393|NCT00567489|3184507|Superiority||Mean Difference (Final Values)|0.3||||0.581|2-Sided|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6|
1728394|NCT00567489|3184507|Superiority||Mean Difference (Final Values)|0.0||||0.961|2-Sided|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3|
1728395|NCT00567489|3184508|Superiority||Mean Difference (Final Values)|0.7||||0.716|2-Sided|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6|
1728396|NCT00567489|3184508|Superiority||Mean Difference (Final Values)|-0.3||||0.884|2-Sided|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3|
1728397|NCT00567489|3184509|Superiority||Mean Difference (Final Values)|3.0||||0.019|2-Sided|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6|
1728398|NCT00567489|3184509|Superiority||Mean Difference (Final Values)|3.2||||0.019|2-Sided|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3|
1734612|NCT00509392|3193639|Superiority or Other|||||||0.0002|||||||t-test, 2 sided||||
1728399|NCT00567489|3184510|Superiority||Mean Difference (Final Values)|-0.2|||<|0.001|2-Sided|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6|
1728400|NCT00567489|3184510|Superiority||Mean Difference (Final Values)|-0.2|||<|0.012|2-Sided|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3|
1728401|NCT00567489|3184510|Superiority||Mean Difference (Final Values)|-10.3|||<|0.001|2-Sided|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6|
1728402|NCT00567489|3184510|Superiority||Mean Difference (Final Values)|-10.2|||<|0.127|2-Sided|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3|
1728403|NCT00567489|3184511|Superiority||Mean Difference (Final Values)|1.4||||0.091|2-Sided|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6|
1728404|NCT00567489|3184511|Superiority||Mean Difference (Final Values)|-0.2||||0.817|2-Sided|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3|
1728405|NCT00567489|3184511|Superiority||Mean Difference (Final Values)|1.3||||0.029|2-Sided|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6|
1728406|NCT00567489|3184511|Superiority||Mean Difference (Final Values)|0.6||||0.338|2-Sided|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3|
1728407|NCT00567489|3184512|Superiority||Mean Difference (Final Values)|0.89||||0.624|2-Sided|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6|
1728408|NCT00567489|3184513|Superiority||Mean Difference (Final Values)|13.5||||0.247|2-Sided|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6|
1728409|NCT00567489|3184513|Superiority||Mean Difference (Final Values)|-4.2||||0.721|2-Sided|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3|
1728410|NCT00567489|3184514|Superiority||Mean Difference (Final Values)|121.8||||0.82|2-Sided|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6|
1728411|NCT00567489|3184514|Superiority||Mean Difference (Final Values)|441.3||||0.419|2-Sided|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3|
1728412|NCT00567489|3184514|Superiority||Mean Difference (Final Values)|-29.2||||0.811|2-Sided|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6|
1728413|NCT00567489|3184514|Superiority||Mean Difference (Final Values)|-56.5||||0.655|2-Sided|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3|
1728414|NCT00567489|3184515|Superiority||Mean Difference (Final Values)|8.4||||0.03|2-Sided|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6|
1728415|NCT00567489|3184515|Superiority||Mean Difference (Final Values)|11.4||||0.004|2-Sided|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3|
1728416|NCT00567489|3184515|Superiority||Mean Difference (Final Values)|5.0||||0.134|2-Sided|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6|
1728417|NCT00567489|3184515|Superiority||Mean Difference (Final Values)|5.6||||0.101|2-Sided|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3|
1728418|NCT00567489|3184515|Superiority||Mean Difference (Final Values)|-1.9||||0.556|2-Sided|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6|
1728419|NCT00567489|3184515|Superiority||Mean Difference (Final Values)|-2.3||||0.485|2-Sided|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3|
1728420|NCT00567489|3184516|Superiority||Mean Difference (Final Values)|0.7||||0.002|2-Sided|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6|
1728421|NCT00567489|3184516|Superiority||Mean Difference (Final Values)|0.8|||<|0.001|2-Sided|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3|
1728422|NCT00567489|3184516|Superiority||Mean Difference (Final Values)|0.3|||<|0.003|2-Sided|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6|
1728423|NCT00567489|3184516|Superiority||Mean Difference (Final Values)|0.4|||<|0.001|2-Sided|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3|
1728424|NCT00567489|3184516|Superiority||Mean Difference (Final Values)|0.0|||<|0.298|2-Sided|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6|
1728425|NCT00567489|3184516|Superiority||Mean Difference (Final Values)|-0.1|||<|0.198|2-Sided|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3|
1728426|NCT00567489|3184516|Superiority||Mean Difference (Final Values)|0.1|||<|0.593|2-Sided|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6|
1728427|NCT00567489|3184516|Superiority||Mean Difference (Final Values)|0.2|||<|0.181|2-Sided|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3|
1728428|NCT00567489|3184516|Superiority||Median Difference (Final Values)|0.3|||<|0.073|2-Sided|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6|
1728429|NCT00567489|3184516|Superiority||Mean Difference (Final Values)|0.5|||<|0.01|2-Sided|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3|
1728430|NCT00567489|3184518|Superiority||Mean Difference (Final Values)|4.7||||0.342|2-Sided|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6|
1728431|NCT00567489|3184518|Superiority||Mean Difference (Final Values)|5.0||||0.312|2-Sided|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3|
1728432|NCT00567489|3184519|Superiority||Mean Difference (Final Values)|0.5||||0.006|2-Sided|95.0|0.1|0.8|||ANOVA|||Month 6|
1728433|NCT00567489|3184519|Superiority||Mean Difference (Final Values)|0.6|||<|0.001|2-Sided|95.0|0.2|0.9|||ANOVA|||Month 3|
1728434|NCT00567398|3184530|Superiority||Mean Difference (Final Values)|-0.2||||0.955|2-Sided|95.0|-6.9|6.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6|
1728435|NCT00567398|3184531|Superiority||Mean Difference (Final Values)|2.4||||0.82|2-Sided|95.0|-18.3|23.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6|
1728436|NCT00567398|3184531|Superiority||Mean Difference (Final Values)|2.3||||0.832|2-Sided|95.0|-18.9|23.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6|
1728437|NCT00567398|3184532|Superiority||Mean Difference (Final Values)|7.8||||0.486|2-Sided|95.0|-14.5|30.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6|
1728438|NCT00567398|3184532|Superiority||Mean Difference (Final Values)|6.3||||0.626|2-Sided|95.0|-19.3|31.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6|
1728439|NCT00567398|3184533|Superiority||Mean Difference (Final Values)|55.4||||0.081|2-Sided|95.0|-7.0|117.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6|
1728440|NCT00567398|3184533|Superiority||Mean Difference (Final Values)|24.6||||0.495|2-Sided|95.0|-46.9|96.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6|
1728441|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|2.38||||0.34|2-Sided|95.0|-2.52|7.28|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6|
1728442|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|-0.09||||0.97|2-Sided|95.0|-4.93|4.75|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3|
1728443|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|-0.33||||0.906|2-Sided|95.0|-5.79|5.14|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6|
1728444|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|-1.5||||0.586|2-Sided|95.0|-6.89|3.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3|
1728445|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|1.62||||0.641|2-Sided|95.0|-5.22|8.47|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6|
1728446|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|1.89||||0.585|2-Sided|95.0|-4.9|8.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3|
1728447|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|3.13||||0.209|2-Sided|95.0|-1.75|8.01|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6|
1728448|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|0.2||||0.934|2-Sided|95.0|-4.63|5.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3|
1728449|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|7.21||||0.01|2-Sided|95.0|1.7|12.73|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6|
1728450|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|1.07||||0.701|2-Sided|95.0|-4.4|6.54|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3|
1728451|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|4.41||||0.128|2-Sided|95.0|-1.28|10.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6|
1728452|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|0.41||||0.885|2-Sided|95.0|-5.22|6.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3|
1728453|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|-0.72||||0.78|2-Sided|95.0|-5.78|4.34|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6|
1728454|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|-2.95||||0.246|2-Sided|95.0|-7.95|2.04|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3|
1728455|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|0.83||||0.779|2-Sided|95.0|-5.01|6.68|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6|
1728456|NCT00567398|3184534|Superiority||Mean Difference (Final Values)|-1.87||||0.526|2-Sided|95.0|-7.64|3.91|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3|
1728457|NCT00567398|3184535|Superiority||Mean Difference (Final Values)|0.02||||0.995|2-Sided|95.0|-6.79|6.83|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6|
1728458|NCT00567398|3184535|Superiority||Mean Difference (Final Values)|2.18||||0.525|2-Sided|95.0|-4.56|8.93|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3|
1728459|NCT00567398|3184536|Superiority||Mean Difference (Final Values)|-0.02||||0.485|2-Sided|95.0|-0.07|0.03|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6|
1728460|NCT00567398|3184536|Superiority||Mean Difference (Final Values)|0.02||||0.412|2-Sided|95.0|-0.03|0.07|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3|
1728461|NCT00567398|3184537|Superiority||Mean Difference (Final Values)|-18.3||||0.854|2-Sided|95.0|-214.4|177.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6|
1728462|NCT00567398|3184537|Superiority||Mean Difference (Final Values)|185.3||||0.377|2-Sided|95.0|-227.5|598.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3|
1728463|NCT00567398|3184537|Superiority||Mean Difference (Final Values)|-1.7||||0.731|2-Sided|95.0|-11.5|8.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6|
1728464|NCT00567398|3184537|Superiority||Mean Difference (Final Values)|5.2||||0.608|2-Sided|95.0|-14.7|25.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3|
1728465|NCT00567398|3184538|Superiority||Mean Difference (Final Values)|-0.3||||0.871|2-Sided|95.0|-3.7|3.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6|
1728466|NCT00567398|3184539|Superiority||Mean Difference (Final Values)|0.3||||0.581|2-Sided|95.0|-0.8|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6|
1728467|NCT00567398|3184539|Superiority||Mean Difference (Final Values)|0.0||||0.961|2-Sided|95.0|-1.2|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3|
1728468|NCT00567398|3184540|Superiority||Mean Difference (Final Values)|0.7||||0.716|2-Sided|95.0|-3.0|4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6|
1728469|NCT00567398|3184540|Superiority||Mean Difference (Final Values)|-0.3||||0.884|2-Sided|95.0|-3.9|3.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3|
1728470|NCT00567398|3184541|Superiority||Mean Difference (Final Values)|3.0||||0.019|2-Sided|95.0|0.5|5.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6|
1728471|NCT00567398|3184541|Superiority||Mean Difference (Final Values)|3.2||||0.019|2-Sided|95.0|0.5|5.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3|
1728472|NCT00567398|3184542|Superiority||Mean Difference (Final Values)|-0.2|||<|0.001|2-Sided|95.0|-0.3|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6|
1728473|NCT00567398|3184542|Superiority||Mean Difference (Final Values)|-0.2|||<|0.012|2-Sided|95.0|-0.4|-0.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3|
1728474|NCT00567398|3184542|Superiority||Mean Difference (Final Values)|-10.3|||<|0.001|2-Sided|95.0|-16.4|-4.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6|
1728475|NCT00567398|3184542|Superiority||Mean Difference (Final Values)|-10.2|||<|0.127|2-Sided|95.0|-23.3|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3|
1728476|NCT00567398|3184543|Superiority||Mean Difference (Final Values)|1.4||||0.091|2-Sided|95.0|-0.2|2.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6|
1728477|NCT00567398|3184543|Superiority||Mean Difference (Final Values)|-0.2||||0.817|2-Sided|95.0|-1.9|1.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3|
1728478|NCT00567398|3184543|Superiority||Mean Difference (Final Values)|1.3||||0.029|2-Sided|95.0|0.1|2.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6|
1728479|NCT00567398|3184543|Superiority||Mean Difference (Final Values)|0.6||||0.338|2-Sided|95.0|-0.6|1.8|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3|
1728480|NCT00567398|3184544|Superiority||Mean Difference (Final Values)|0.89||||0.624|2-Sided|95.0|0.55|1.43|||ANOVA|||Estimates of Ratio-Month 6|
1728481|NCT00567398|3184545|Superiority||Mean Difference (Final Values)|13.5||||0.247|2-Sided|95.0|-9.4|36.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6|
1728482|NCT00567398|3184545|Superiority||Mean Difference (Final Values)|-4.2||||0.721|2-Sided|95.0|-27.5|19.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3|
1728483|NCT00567398|3184546|Superiority||Mean Difference (Final Values)|121.8||||0.82|2-Sided|95.0|-927.9|1171.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6|
1728484|NCT00567398|3184546|Superiority||Mean Difference (Final Values)|441.3||||0.419|2-Sided|95.0|-630.4|1513.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3|
1728485|NCT00567398|3184546|Superiority||Mean Difference (Final Values)|-29.2||||0.811|2-Sided|95.0|-268.9|210.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6|
1728486|NCT00567398|3184546|Superiority||Mean Difference (Final Values)|-56.5||||0.655|2-Sided|95.0|-304.6|191.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3|
1728487|NCT00567398|3184547|Superiority||Mean Difference (Final Values)|8.4||||0.03|2-Sided|95.0|0.8|15.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6|
1728488|NCT00567398|3184547|Superiority||Mean Difference (Final Values)|11.4||||0.004|2-Sided|95.0|3.6|19.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3|
1728489|NCT00567398|3184547|Superiority||Mean Difference (Final Values)|5.0||||0.134|2-Sided|95.0|-1.5|11.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6|
1728490|NCT00567398|3184547|Superiority||Mean Difference (Final Values)|5.6||||0.101|2-Sided|95.0|-1.1|12.2|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3|
1728491|NCT00567398|3184547|Superiority||Mean Difference (Final Values)|-1.9||||0.556|2-Sided|95.0|-8.2|4.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6|
1728492|NCT00567398|3184547|Superiority||Mean Difference (Final Values)|-2.3||||0.485|2-Sided|95.0|-8.6|4.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3|
1728493|NCT00567398|3184548|Superiority||Mean Difference (Final Values)|0.7||||0.002|2-Sided|95.0|0.3|1.1|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6|
1728494|NCT00567398|3184548|Superiority||Mean Difference (Final Values)|0.8|||<|0.001|2-Sided|95.0|0.4|1.3|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3|
1728495|NCT00567398|3184548|Superiority||Mean Difference (Final Values)|0.3|||<|0.003|2-Sided|95.0|0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6|
1728496|NCT00567398|3184548|Superiority||Mean Difference (Final Values)|0.4|||<|0.001|2-Sided|95.0|0.2|0.6|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3|
1728497|NCT00567398|3184548|Superiority||Mean Difference (Final Values)|0.0|||<|0.298|2-Sided|95.0|-0.1|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6|
1728498|NCT00567398|3184548|Superiority||Mean Difference (Final Values)|-0.1|||<|0.198|2-Sided|95.0|-0.2|0.0|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3|
1728499|NCT00567398|3184548|Superiority||Mean Difference (Final Values)|0.1|||<|0.593|2-Sided|95.0|-0.2|0.4|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6|
1728500|NCT00567398|3184548|Superiority||Mean Difference (Final Values)|0.2|||<|0.181|2-Sided|95.0|-0.1|0.5|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3|
1728501|NCT00567398|3184548|Superiority||Median Difference (Final Values)|0.3|||<|0.073|2-Sided|95.0|0.0|0.7|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6|
1728502|NCT00567398|3184548|Superiority||Mean Difference (Final Values)|0.5|||<|0.01|2-Sided|95.0|0.1|0.9|||ANOVA|||Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3|
1728503|NCT00567398|3184550|Superiority||Mean Difference (Final Values)|4.7||||0.342|2-Sided|95.0|-5.0|14.4|||ANOVA|||Insulin-Month 6|
1728504|NCT00567398|3184550|Superiority||Mean Difference (Final Values)|5.0||||0.312|2-Sided|95.0|-4.7|14.7|||ANOVA|||Insulin-Month 3|
1728505|NCT00567398|3184551|Superiority||Mean Difference (Final Values)|0.5||||0.006|2-Sided|95.0|0.1|0.8|||ANOVA|||Month 6|
1728506|NCT00567398|3184551|Superiority||Mean Difference (Final Values)|0.6|||<|0.001|2-Sided|95.0|0.2|0.9|||ANOVA|||Month 3|
1728507|NCT00567320|3184556|Superiority or Other (legacy)|||||||0.84|||||||Mixed Models Analysis|||HLM analysis of % of Cocaine Positive Urines per week over 12 weeks. Subjects were used as a Random variable, with medication dosing set to 'Fixed'.|
1728508|NCT00567268|3184558|Superiority or Other||||||=|0|||||||Chi-squared|||"The factor tested was non-drug therapy. The null hypothesis was that there was no difference between the non-drug therapy and the number of participants who responded to the treatment with gabapentin."|
1728509|NCT00567268|3184559|Superiority or Other||||||=|0|||||||Cochran-Armitage|||"The factor tested was baseline creatinine clearance. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the baseline creatinine clearance."|
1728510|NCT00567268|3184560|Superiority or Other||||||<|0.001|||||||Cochran-Armitage|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."|
1728511|NCT00567268|3184560|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no association between the number of concomitant antiepileptic drugs at baseline and the number of participants who responded to the treatment with gabapentin."|
1728512|NCT00567268|3184561|Superiority or Other||||||=|0|||||||Chi-squared|||"The factor tested was baseline frequency of epileptic seizure. The null hypothesis was that there was no difference between the baseline frequency of epileptic seizure and the number of participants who responded to the treatment with gabapentin."|
1728513|NCT00567268|3184562|Superiority or Other||||||=|0|||||||Cochran-Armitage|||"The factor tested was severity of partial epileptic seizure. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across the degree of severity of partial epileptic seizure (mild, moderate, and severe)."|
1728514|NCT00567268|3184562|Superiority or Other||||||=|0|||||||Chi-squared|||"The factor tested was severity of partial epileptic seizure . The null hypothesis was that there was no association between the degree of severity of partial epileptic seizure (mild, moderate, and severe) and the number of participants who responded to the treatment with gabapentin."|
1728515|NCT00567268|3184563|Superiority or Other||||||<|0.001|||||||Cochran-Armitage|||"The factor tested was age. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of age categories."|
1728516|NCT00567268|3184563|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The factor tested was age. The null hypothesis was that there was no association between the age and the number of participants who responded to the treatment with gabapentin."|
1728517|NCT00567268|3184564|Superiority or Other||||||<|0.001|||||||Chi-squared|||"The factor tested was age. The null hypothesis was that there was no difference between <65 years and >=65 years in the number of participants who responded to the treatment with gabapentin."|
1728518|NCT00567268|3184565|Superiority or Other||||||=|0|||||||Cochran-Armitage|||"The risk factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."|
1728519|NCT00567268|3184565|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was number of concomitant antiepileptic drugs at baseline. The null hypothesis was that there was no linear trend in the number of responders to the treatment with gabapentin across increasing levels of the number of concomitant antiepileptic drugs at baseline."|
1728520|NCT00567268|3184566|Superiority or Other||||||=|0|||||||Fisher Exact|||"The risk factor tested was age. The null hypothesis was that there was no association between the age and the number of responders to the treatment with gabapentin."|
1728521|NCT00567255|3184573|Superiority or Other||Mean Difference (Net)|-0.48|||||2-Sided|95.0|-0.98|0.02||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1728522|NCT00567255|3184574|Superiority or Other||Mean Difference (Net)|-0.02|||||2-Sided|95.0|-0.56|0.52||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1728523|NCT00567255|3184575|Superiority or Other||Mean Difference (Net)|0.06|||||2-Sided|95.0|-0.49|0.6||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1728524|NCT00567255|3184576|Superiority or Other||Mean Difference (Net)|0.87|||||2-Sided|95.0|0.16|1.58||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1728525|NCT00567255|3184577|Superiority or Other||Mean Difference (Net)|0.3|||||2-Sided|95.0|-0.7|1.3||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1728526|NCT00567255|3184578|Superiority or Other||Mean Difference (Net)|-4.36|||||2-Sided|95.0|-7.29|-1.44||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1728527|NCT00567255|3184579|Superiority or Other||Mean Difference (Net)|-7.23|||||2-Sided|95.0|-9.92|-4.54||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1728528|NCT00567255|3184580|Superiority or Other||Mean Difference (Net)|-12.29|||||2-Sided|||||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1728529|NCT00567255|3184581|Superiority or Other||Mean Difference (Net)|-0.38|||||2-Sided|95.0|-1.6|0.85||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1728530|NCT00567255|3184582|Superiority or Other||Mean Difference (Net)|-13.64|||||2-Sided|||||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1728531|NCT00567255|3184583|Superiority or Other||Mean Difference (Net)|-8.24||||0.091|2-Sided||||||ANCOVA||||
1728532|NCT00567255|3184584|Superiority or Other||Mean Difference (Net)|3.77|||<|0.001|2-Sided|95.0|2.46|5.09|||ANCOVA||||
1728533|NCT00567255|3184585|Superiority or Other||Mean Difference (Net)|-5.96||||0.007|2-Sided||||||ANCOVA||||
1728534|NCT00567255|3184586|Superiority or Other||Mean Difference (Net)|2.59|||<|0.001|2-Sided|95.0|1.61|3.57|||ANCOVA||||
1728535|NCT00567255|3184587|Superiority or Other||Mean Difference (Net)|-3.43|||<|0.001|2-Sided|95.0|-4.33|-2.53|||ANCOVA||||
1728536|NCT00567255|3184588|Superiority or Other||Odds Ratio (OR)|5.36|||<|0.001|2-Sided|95.0|3.6|7.98|||Regression, Logistic||||
1728537|NCT00567255|3184589|Superiority or Other||Odds Ratio (OR)|5.5|||<|0.001|2-Sided|95.0|4.05|7.47|||Regression, Logistic||||
1728538|NCT00567255|3184590|Superiority or Other||Odds Ratio (OR)|6.61|||<|0.001||95.0|4.95|8.84|||Regression, Logistic||||
1728539|NCT00567255|3184591|Superiority or Other||Mean Difference (Net)|-5.16|||<|0.001|2-Sided|95.0|-5.95|-4.38|||ANCOVA||||
1728540|NCT00567255|3184592|Superiority or Other||Mean Difference (Net)|-4.56|||<|0.001||95.0|-5.19|-3.93|||ANCOVA||||
1728541|NCT00567242|3184593|Superiority or Other||Mean Difference (Final Values)|1.56|Standard Error of the Mean|0.73|<|0.05|1-Sided|95.0|0.26||||t-test, 1 sided|||"H1: The Intention Group would show more improvement across treatment than the Control Group.~H0: The Intention Group and the Control Group would not show any difference in improvement across treatment."|
1728542|NCT00567242|3184594|Superiority or Other||Median Difference (Final Values)|-0.24|Standard Error of the Mean|0.88|<|0.05|1-Sided|95.0|-1.81||||t-test, 1 sided|||"H1: The Intention Group would show more improvement across treatment than the Control Group.~H0: The Intention Group and the Control Group would not show any difference in improvement across treatment."|
1728543|NCT00567242|3184595|Superiority or Other||Mean Difference (Final Values)|-0.1832|Standard Error of the Mean|0.2768|<|0.05|1-Sided|95.0||0.3546|||t-test, 1 sided|||"H1: The Control Group will show a significant rightward shift in lateral frontal lateral indices from pre-treatment to post-treatment.~H0: The Control group will show no shift in lateral frontal laterality indices from pre-treatment to post-treatment.~Since the analysis to test these hypotheses is a repeated-measures t-test, the mean and standard deviation are given for post-treatment laterality index minus pre-treatment laterality index."|
1728544|NCT00567242|3184595|Superiority or Other||Mean Difference (Final Values)|-0.2801|Standard Error of the Mean|0.1077|<|0.05|1-Sided|95.0||-0.0709|||t-test, 1 sided|||"H1: The Intention Group will show a significant rightward shift in lateral frontal laterality from pre-treatment to post-treatment.~H0: The Intention Group will show no shift in lateral frontal laterality from pre-treatment to post-treatment.~Since this is a repeated measures t test, the data are presented as the mean and standard deviation for for the post-treatment laterality index minus the pre-treatment laterality index."|
1728545|NCT00567190|3184599|Other|||||||0.7174|||||||Wilcoxon Rank Sum Test|||Wilcoxon Test of Maximum Decrease in LVEF From BL|
1728546|NCT00567190|3184608|Superiority||Cox Proportional Hazard|0.97||||0.7161|2-Sided|95.0|0.81|1.16||Stratified by prior treatment status and region.|Log Rank (stratified)||Hazard ratio is comparing Pertuzumab arm with Placebo arm.||
1728547|NCT00567190|3184609|Superiority||Cox Proportional Hazard|0.66|||||2-Sided|95.0|0.51|0.85|||||||
1728548|NCT00567190|3184610|Superiority||Odds Ratio (OR)|1.79|||||2-Sided|95.0|1.26|2.54||||||Odds Ratio for Objective Response (CR + PR)|
1728549|NCT00567190|3184610|Superiority||Difference in Objective Response Rates|10.83||||0.0011|2-Sided|95.0|4.2|17.5|||Mantel Haenszel|Stratified by prior treatment status and region.|Difference in the objective response rates between arms is calculated as Pertuzumab arm minus Placebo arm. The 95% CI was calculated using the Hauck-Anderson method.|Difference in Objective Response (CR + PR) Between Arms|
1728550|NCT00567190|3184611|Superiority||Cox Proportional Hazard|0.69|||<|0.0001|2-Sided|95.0|0.59|0.81|||Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|PFS by Investigator - Stratified|
1728551|NCT00567190|3184612|Superiority||Cox Proportional Hazard|0.64||||0.005|2-Sided|95.0|0.47|0.88||The threshold for statistical significance was HR≤0.603, p≤0.0012.|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio (HR) is comparing pertuzumab with placebo arms.|First Interim OS Analysis: For this first interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.603, p≤0.0012.|
1728552|NCT00567190|3184612|Superiority||Cox Proportional Hazard|0.66||||0.0008|2-Sided|95.0|0.52|0.84||The threshold for statistical significance was HR≤0.739, p≤0.0138.|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio (HR) is comparing Pertuzumab arm with Placebo arm.|Second Interim OS Analysis: For this second interim OS analysis, the pre-defined O'Brien-Fleming stopping boundary for the Lan-DeMets α-spending function was: HR≤0.739, p≤0.0138.|
1728553|NCT00567190|3184612|Superiority|Exploratory|Cox Proportional Hazard|0.68||||0.0002|2-Sided|95.0|0.56|0.84||Exploratory|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|Event-Driven Final OS Analysis: This final OS analysis was event-driven and planned to take place after a total of 385 deaths had occurred. It is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.|
1728554|NCT00567190|3184612|Superiority|Exploratory|Cox Proportional Hazard|0.69|||<|0.0001|2-Sided|95.0|0.58|0.82||Exploratory|Log Rank (stratified)|Stratified by prior treatment status and region.|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|End-of-Study OS Analysis: This end-of-study OS analysis is considered exploratory only as the confirmatory OS analysis for statistical interpretation had previously occurred at the second interim OS analysis.|
1728555|NCT00567190|3184613|Superiority||Cox Proportional Hazard|0.63|||<|0.0001|2-Sided|95.0|0.52|0.76||Tested at two-sided 5% significance level|Log Rank (unstratified)|Unstratified|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.|
1729614|NCT00560417|3185576|Superiority or Other|||||||0.06||||||p-value is for Endpoint (LOCF): HbA1c <=6.5%|Fisher Exact||||
1728556|NCT00567190|3184613|Superiority||Cox Proportional Hazard|0.62|||<|0.0001|2-Sided|95.0|0.51|0.75||Tested at two-sided 5% significance level|Log Rank (stratified)|Stratified by prior treatment status and region|Hazard ratio is comparing Pertuzumab arm with Placebo arm.|The null hypothesis (H0) was that the survival distributions of PFS in the two treatments arms (pertuzumab vs. placebo) are the same. The alternative hypothesis (H1) was that the survival distribution of PFS in the experimental arm (pertuzumab) and control arm (placebo) are different.|
1728557|NCT00567164|3184636|Superiority or Other||Mean Difference (Final Values)|-11.85|Standard Deviation|30.356||0.0001||95.0|-16.3|-7.394|||t-test, 2 sided||||
1728558|NCT00567112|3184638|Superiority or Other||||||>|0.2|||||||ANOVA|||OCT (after meal)/OCT (fasted)|
1728559|NCT00567112|3184639|Superiority or Other||||||<|0.001|||||||ANOVA|||OCT (after meal)/OCT (fasted)|
1728560|NCT00567112|3184640|Superiority or Other||||||>|0.2|||||||ANOVA|||OCT (fasted)/DFC (fasted)|
1728561|NCT00567112|3184641|Superiority or Other||||||>|0.2|||||||ANOVA|||OCT (fasted)/DFC (fasted)|
1728562|NCT00567112|3184642|Non-Inferiority or Equivalence|Geometric Mean Ratio OCT (after meal)/OCT (fasted)|Geometric Mean Ratio|0.59|||<|0.001|2-Sided|90.0|0.49|0.72|||ANOVA|||OCT (after meal)/OCT (fasted)|
1728563|NCT00567112|3184643|Non-Inferiority or Equivalence|Geometric Mean Ratio of OCT (after meal)/OCT (fasted)|Geometric Mean Ratio|0.92||||0.026|2-Sided|90.0|0.86|0.98|||ANOVA|||OCT (after meal)/OCT (fasted)|
1728564|NCT00567112|3184644|Non-Inferiority or Equivalence|Geometric Mean Ratio of OCT (fasted)/DFC (fasted)|Geometric Mean Ratio|0.98|||>|0.2|2-Sided|90.0|0.8|1.19|||ANOVA|||OCT (fasted)/DFC (fasted)|
1728565|NCT00567112|3184645|Non-Inferiority or Equivalence|Geometric Mean Ratio of OCT (fasted)/DFC (fasted)|Geometric Mean Ratio|0.98|||>|0.2|2-Sided|90.0|0.92|1.05|||ANOVA|||OCT (fasted)/DFC (fasted)|
1728566|NCT00566969|3184665|Non-Inferiority or Equivalence (legacy)|A hierarchical linear model was used to account for unequal variance and covariance structures across time.||||||0.1|||||||ANOVA||||
1728567|NCT00566852|3184672|Superiority||Hazard Ratio (HR)|1.06||||0.025|2-Sided|95.0|0.86|1.31|||Log Rank|||The stratified log-rank test was used to test for a statistically significant difference in survival distributions with a one-sided alpha of 0.025 . In addition, the Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.|
1728568|NCT00566852|3184673|Superiority||Hazard Ratio (HR)|1.06||||0.27|2-Sided|95.0|0.87|1.3|||Log Rank|||The stratified log-rank test was used to test for a statistically significant difference in survival distributions with a one-sided alpha of 0.025 . In addition, the Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.|
1728569|NCT00566852|3184674|Superiority|||||||0.77|||||||Wilcoxon (Mann-Whitney)|||Assuming normally distributions, the two sample t-test assuming equal variances would be used to compare the arms at the 0.025 significance level. If normality assumptions were not met, the Wilcoxon rank sum would be used.|
1728570|NCT00566852|3184675|Superiority||Hazard Ratio (HR)|0.78||||0.01|2-Sided|95.0|0.62|0.99|||Gray's test|||A one-sided log-rank test with alpha 0.025 accruing 221 patients/arm with 12 months of follow-up would ensure 98% statistical power to detect a 33% relative reduction in the monthly hazard rate with the use of memantine. Gray’s test was used to test for a statistically significant difference in the distribution of neurocognitive failure times and Cox proportional hazards regression model was used to determine hazard ratios and 95% confidence intervals for the treatment difference.|
1728571|NCT00566852|3184676|Superiority|||||||0.397||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||52 weeks|
1728572|NCT00566852|3184676|Superiority|||||||0.4541||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||16 weeks|
1728573|NCT00566852|3184676|Superiority|||||||0.0692||||||One-sided significance level of 0.025|Wilcoxon (Mann-Whitney)|||8 weeks|
1728574|NCT00566852|3184677|Superiority or Other|||||||0.059||||||Significance level was 0.025.|Wilcoxon (Mann-Whitney)|||Null hypothesis: patients on memantine will experience less decline than patients receiving placebo. Based on a one-sided Wilcoxon rank sum test with alpha=0.025, 221 patients per arm would be required to have 80% statistical power to detect a mean difference of 0.87 in the HVLT-R change scores between the two treatment arms. Assuming that 20% of patients may be ineligible, or die prior to the 24 week assessment, the target sample size for randomization was set to 536.|
1728575|NCT00566735|3184682|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|Degrees of freedom = 28||Independent t-test to assess differences between the placebo and galantamine groups in regard to pre- and post-ECT scores on the Delayed Memory Index (DMI).|
1728576|NCT00566709|3184697|Superiority or Other|||||||0.22|||||||Chi-squared, Corrected||||
1728577|NCT00566709|3184698|Superiority or Other|||||||0.77|||||||Chi-squared, Corrected||||
1728578|NCT00566709|3184699|Superiority or Other|||||||0.79|||||||t-test, 2 sided||||
1728579|NCT00566709|3184700|Superiority or Other|||||||0.56|||||||Chi-squared, Corrected||||
1728580|NCT00566709|3184701|Superiority or Other|||||||0.07|||||||Chi-squared, Corrected||||
1728581|NCT00566709|3184702|Superiority or Other|||||||0.03|||||||t-test, 2 sided||||
1728582|NCT00566527|3184733|Non-Inferiority or Equivalence|Non-inferiority was declared when the lower bound of the 95% CI was > -10. Values are shown as percentages.|Varicella Response Rate (Arm 1 - Arm 3)|0.0|||||2-Sided|95.0|-1.83|1.1||||||Varicella difference|
1728583|NCT00566527|3184733|Non-Inferiority or Equivalence|Non-inferiority was declared when the lower bound of the 95% CI was > -5. Values are shown as percentages.|Rubella Response Rate (Arm 1 - Arm 3)|-0.15|||||2-Sided|95.0|-1.34|1.09||||||Rubella difference|
1728584|NCT00566527|3184733|Non-Inferiority or Equivalence|Non-inferiority was declared when the lower bound of the 95% CI was > -5. Values are shown as percentages.|Mumps Response Rate (Arm 1 - Arm 3)|-0.35|||||2-Sided|95.0|-1.71|1.01||||||Mumps difference|
1728585|NCT00566527|3184733|Non-Inferiority or Equivalence|Non-inferiority was declared when the lower bound of the 95% CI was > -5. Values are shown as percentages.|Measles Response Rate (Arm 1 - Arm 3)|-3.97|||||2-Sided|95.0|-6.44|-1.87||||||Measles difference|
1728586|NCT00566527|3184734|Non-Inferiority or Equivalence|Non-inferiority was declared when the lower bound of the 95% CI was > -10. Values are shown as percentages.|Varicella Response Rate (Arm 2 - Arm 3)|0.0|||||2-Sided|95.0|-1.28|1.1||||||Varicella difference|
1728587|NCT00566527|3184734|Non-Inferiority or Equivalence|Non-inferiority was declared when the lower bound of the 95% CI was > -5. Values are shown as percentages.|Rubella Response Rate (Arm 2 - Arm 3)|-0.22|||||2-Sided|95.0|-1.55|1.03||||||Rubella difference|
1728588|NCT00566527|3184734|Non-Inferiority or Equivalence|Non-inferiority was declared when the lower bound of the 95% CI was > -5. Values are shown as percentages.|Mumps Response Rate (Arm 2 - Arm 3)|0.03|||||2-Sided|95.0|-1.2|1.32||||||Mumps difference|
1728589|NCT00566527|3184734|Non-Inferiority or Equivalence|Non-inferiority was declared when the lower bound of the 95% CI was > -5. Values are shown as percentages.|Measles Response Rate (Arm 2 - Arm 3)|-0.91|||||2-Sided|95.0|-2.82|0.87||||||Measles difference|
1728590|NCT00566228|3184747|Superiority|||||||0.679|||||||Log Rank||||
1728591|NCT00566228|3184750|Superiority||Hazard Ratio (HR)|1.13||||0.69|2-Sided|95.0|0.62|2.08|||Log Rank||||
1728592|NCT00566150|3184751|Superiority or Other (legacy)|||||||0.79||||||Unadjusted. Statistical significance was p<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups.|
1728593|NCT00566150|3184752|Superiority or Other (legacy)|||||||0.038||||||Statistical significance was p<0.05|Fisher Exact|Fisher's exact test was used to test for significance between groups.||Week 6|
1728594|NCT00566150|3184753|Superiority or Other (legacy)|||||||0.07||||||Unadjusted. Statistical significance was p<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups at week 6.|
1728595|NCT00566150|3184754|Superiority or Other (legacy)|||||||0.29||||||Unadjusted. Statistical significance was p<0.05.|Mixed Models Analysis|Fixed categorical effects: group (as a between-subjects factor), time (as a within-subjects factor), group x time interaction.||Comparison of changes in outcome between treatment groups at week 6.|
1728596|NCT00565812|3184804|Superiority or Other||LS mean difference|-1.16|Standard Error of the Mean|0.57||0.041|2-Sided|95.0|-2.28|-0.05|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728597|NCT00565812|3184804|Superiority or Other||LS mean difference|-1.18|Standard Error of the Mean|0.57||0.038|2-Sided|95.0|-2.3|-0.06|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728598|NCT00565812|3184804|Superiority or Other||LS mean difference|-0.87|Standard Error of the Mean|0.54||0.104|2-Sided|95.0|-1.92|0.18|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728599|NCT00565812|3184804|Superiority or Other||LS mean difference|-0.6|Standard Error of the Mean|0.54||0.269|2-Sided|95.0|-1.66|0.46|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728600|NCT00565812|3184804|Superiority or Other||LS mean difference|-1.87|Standard Error of the Mean|0.56|<|0.001|2-Sided|95.0|-2.98|-0.77|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728601|NCT00565812|3184804|Superiority or Other||LS mean difference|-1.32|Standard Error of the Mean|0.57|<|0.02|2-Sided|95.0|-2.43|-0.21|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728602|NCT00565812|3184804|Superiority or Other||LS mean difference|-0.44|Standard Error of the Mean|0.52|<|0.403|2-Sided|95.0|-1.47|0.59|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728603|NCT00565812|3184804|Superiority or Other||LS mean difference|-0.48|Standard Error of the Mean|0.53|<|0.365|2-Sided|95.0|-1.52|0.56|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728604|NCT00565812|3184804|Superiority or Other||LS mean difference|-1.26|Standard Error of the Mean|0.53|<|0.018|2-Sided|95.0|-2.3|-0.22|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728605|NCT00565812|3184804|Superiority or Other||LS mean difference|-0.33|Standard Error of the Mean|0.54|<|0.539|2-Sided|95.0|-1.38|0.72|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728859|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|3.93|||<|0.0002|2-Sided|95.0|1.5|10.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1728606|NCT00565812|3184804|Superiority or Other||LS mean difference|-0.99|Standard Error of the Mean|0.52|<|0.055|2-Sided|95.0|-2.0|0.02|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728607|NCT00565812|3184804|Superiority or Other||LS mean difference|-0.51|Standard Error of the Mean|0.52|<|0.334|2-Sided|95.0|-1.53|0.52|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728608|NCT00565812|3184804|Superiority or Other||LS mean difference|-0.66|Standard Error of the Mean|0.5|<|0.185|2-Sided|95.0|-1.63|0.32|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728609|NCT00565812|3184804|Superiority or Other||LS mean difference|0.66|Standard Error of the Mean|0.5|<|0.186|2-Sided|95.0|-0.32|1.64|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728610|NCT00565812|3184804|Superiority or Other||LS mean difference|-0.41|Standard Error of the Mean|0.46|<|0.376|2-Sided|95.0|-1.32|0.5|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728611|NCT00565812|3184804|Superiority or Other||LS mean difference|0.33|Standard Error of the Mean|0.46|<|0.474|2-Sided|95.0|-0.58|1.24|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728612|NCT00565812|3184804|Superiority or Other||LS mean difference|-0.67|Standard Error of the Mean|0.46|<|0.14|2-Sided|95.0|-1.57|0.22|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728613|NCT00565812|3184804|Superiority or Other||LS mean difference|-0.35|Standard Error of the Mean|0.46|<|0.44|2-Sided|95.0|-1.25|0.54|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728614|NCT00565812|3184804|Superiority or Other||LS mean difference|-1.18|Standard Error of the Mean|0.44|<|0.008|2-Sided|95.0|-2.05|-0.31|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728615|NCT00565812|3184804|Superiority or Other||LS mean difference|-0.05|Standard Error of the Mean|0.44|<|0.908|2-Sided|95.0|-0.92|0.82|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728616|NCT00565812|3184805|Superiority or Other||LS mean difference|0.6|Standard Error of the Mean|0.54||0.268|2-Sided|95.0|-0.46|1.67|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728617|NCT00565812|3184805|Superiority or Other||LS mean difference|0.07|Standard Error of the Mean|0.55||0.895|2-Sided|95.0|-1.0|1.15|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728618|NCT00565812|3184805|Superiority or Other||LS mean difference|0.59|Standard Error of the Mean|0.52||0.257|2-Sided|95.0|-0.43|1.62|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728619|NCT00565812|3184805|Superiority or Other||LS mean difference|-0.09|Standard Error of the Mean|0.53||0.868|2-Sided|95.0|-1.13|0.95|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728620|NCT00565812|3184805|Superiority or Other||LS mean difference|1.11|Standard Error of the Mean|0.54||0.038|2-Sided|95.0|0.06|2.16|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1734613|NCT00509392|3193640|Superiority or Other|||||||0.0009|||||||t-test, 2 sided||||
1728621|NCT00565812|3184805|Superiority or Other||LS mean difference|-0.23|Standard Error of the Mean|0.54||0.668|2-Sided|95.0|-1.29|0.83|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728622|NCT00565812|3184805|Superiority or Other||LS mean difference|1.08|Standard Error of the Mean|0.51||0.032|2-Sided|95.0|0.09|2.07|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728623|NCT00565812|3184805|Superiority or Other||LS mean difference|-0.24|Standard Error of the Mean|0.51||0.632|2-Sided|95.0|-1.25|0.76|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728624|NCT00565812|3184805|Superiority or Other||LS mean difference|0.01|Standard Error of the Mean|0.5||0.98|2-Sided|95.0|-0.96|0.99|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728625|NCT00565812|3184805|Superiority or Other||LS mean difference|-0.42|Standard Error of the Mean|0.5||0.401|2-Sided|95.0|-1.41|0.56|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728626|NCT00565812|3184805|Superiority or Other||LS mean difference|0.96|Standard Error of the Mean|0.47||0.042|2-Sided|95.0|0.03|1.89|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728627|NCT00565812|3184805|Superiority or Other||LS mean difference|0.6|Standard Error of the Mean|0.48||0.215|2-Sided|95.0|-0.35|1.54|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728628|NCT00565812|3184805|Superiority or Other||LS mean difference|0.89|Standard Error of the Mean|0.45||0.05|2-Sided|95.0|0.0|1.78|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728629|NCT00565812|3184805|Superiority or Other||LS mean difference|0.18|Standard Error of the Mean|0.45||0.687|2-Sided|95.0|-0.71|1.07|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728630|NCT00565812|3184805|Superiority or Other||LS mean difference|1.21|Standard Error of the Mean|0.45||0.007|2-Sided|95.0|0.33|2.09|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728631|NCT00565812|3184805|Superiority or Other||LS mean difference|-0.18|Standard Error of the Mean|0.45||0.683|2-Sided|95.0|-1.07|0.7|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728632|NCT00565812|3184805|Superiority or Other||LS mean difference|1.2|Standard Error of the Mean|0.42||0.004|2-Sided|95.0|0.38|2.02|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728633|NCT00565812|3184805|Superiority or Other||LS mean difference|0.28|Standard Error of the Mean|0.42||0.508|2-Sided|95.0|-0.54|1.1|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728634|NCT00565812|3184805|Superiority or Other||LS mean difference|0.1|Standard Error of the Mean|0.41||0.815|2-Sided|95.0|-0.72|0.91|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728635|NCT00565812|3184805|Superiority or Other||LS mean difference|-0.49|Standard Error of the Mean|0.42||0.238|2-Sided|95.0|-1.31|0.32|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728636|NCT00565812|3184806|Superiority or Other||LS mean difference|0.77|Standard Error of the Mean|0.8||0.333|2-Sided|95.0|-0.79|2.34|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728637|NCT00565812|3184806|Superiority or Other||LS mean difference|-0.16|Standard Error of the Mean|0.8||0.847|2-Sided|95.0|-1.73|1.42|||Mixed Models Analysis|||Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728638|NCT00565812|3184806|Superiority or Other||LS mean difference|0.37|Standard Error of the Mean|0.83||0.659|2-Sided|95.0|-1.26|1.99|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728639|NCT00565812|3184806|Superiority or Other||LS mean difference|-0.72|Standard Error of the Mean|0.84||0.39|2-Sided|95.0|-2.36|0.92|||Mixed Models Analysis|||Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728640|NCT00565812|3184806|Superiority or Other||LS mean difference|0.1|Standard Error of the Mean|0.8||0.897|2-Sided|95.0|-1.47|1.68|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728641|NCT00565812|3184806|Superiority or Other||LS mean difference|-0.85|Standard Error of the Mean|0.81||0.292|2-Sided|95.0|-2.44|0.73|||Mixed Models Analysis|||Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728642|NCT00565812|3184806|Superiority or Other||LS mean difference|1.84|Standard Error of the Mean|0.74||0.013|2-Sided|95.0|0.38|3.3|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728643|NCT00565812|3184806|Superiority or Other||LS mean difference|0.14|Standard Error of the Mean|0.75||0.855|2-Sided|95.0|-1.34|1.61|||Mixed Models Analysis|||Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728644|NCT00565812|3184806|Superiority or Other||LS mean difference|0.34|Standard Error of the Mean|0.72||0.635|2-Sided|95.0|-1.07|1.76|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728645|NCT00565812|3184806|Superiority or Other||LS mean difference|-0.58|Standard Error of the Mean|0.73||0.424|2-Sided|95.0|-2.02|0.85|||Mixed Models Analysis|||Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728646|NCT00565812|3184806|Superiority or Other||LS mean difference|1.03|Standard Error of the Mean|0.74||0.163|2-Sided|95.0|-0.42|2.48|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728647|NCT00565812|3184806|Superiority or Other||LS mean difference|1.2|Standard Error of the Mean|0.75||0.109|2-Sided|95.0|-0.27|2.67|||Mixed Models Analysis|||Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728648|NCT00565812|3184806|Superiority or Other||LS mean difference|1.76|Standard Error of the Mean|0.7||0.012|2-Sided|95.0|0.39|3.13|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728649|NCT00565812|3184806|Superiority or Other||LS mean difference|0.3|Standard Error of the Mean|0.7||0.668|2-Sided|95.0|-1.08|1.68|||Mixed Models Analysis|||Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728650|NCT00565812|3184806|Superiority or Other||LS mean difference|2.52|Standard Error of the Mean|0.71|<|0.001|2-Sided|95.0|1.12|3.92|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728651|NCT00565812|3184806|Superiority or Other||LS mean difference|0.6|Standard Error of the Mean|0.72|<|0.399|2-Sided|95.0|-0.8|2.01|||Mixed Models Analysis|||Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728652|NCT00565812|3184806|Superiority or Other||LS mean difference|1.86|Standard Error of the Mean|0.66|<|0.005|2-Sided|95.0|0.57|3.14|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728653|NCT00565812|3184806|Superiority or Other||LS mean difference|-0.27|Standard Error of the Mean|0.66|<|0.679|2-Sided|95.0|-1.56|1.01|||Mixed Models Analysis|||Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728654|NCT00565812|3184806|Superiority or Other||LS mean difference|0.62|Standard Error of the Mean|0.63|<|0.326|2-Sided|95.0|-0.61|1.85|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728655|NCT00565812|3184806|Superiority or Other||LS mean difference|-0.27|Standard Error of the Mean|0.63|<|0.668|2-Sided|95.0|-1.5|0.96|||Mixed Models Analysis|||Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728656|NCT00565812|3184810|Superiority or Other||Odds Ratio (OR)|1.186||||0.525|2-Sided|95.0|0.701|2.009|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.|
1728657|NCT00565812|3184810|Superiority or Other||Odds Ratio (OR)|1.043||||0.881|2-Sided|95.0|0.602|1.806|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.|
1728658|NCT00565812|3184811|Superiority or Other||Odds Ratio (OR)|0.864||||0.317|2-Sided|95.0|0.65|1.15|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.|
1728659|NCT00565812|3184811|Superiority or Other||Odds Ratio (OR)|0.745||||0.047|2-Sided|95.0|0.557|0.997|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.|
1728660|NCT00565812|3184812|Superiority or Other||Odds Ratio (OR)|1.068||||0.62|2-Sided|95.0|0.824|1.383|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.|
1728661|NCT00565812|3184812|Superiority or Other||Odds Ratio (OR)|1.032||||0.81|2-Sided|95.0|0.797|1.337|||Regression, Logistic|||Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.|
1728662|NCT00565812|3184813|Superiority or Other||LS mean difference|0.02|Standard Error of the Mean|0.09||0.798|2-Sided|95.0|-0.15|0.2|||ANCOVA|||LS-Mean, 95 percent CI and P-values were obtained from an ANCOVA model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.|
1728663|NCT00565812|3184813|Superiority or Other||LS mean difference|-0.03|Standard Error of the Mean|0.09||0.709|2-Sided|95.0|-0.21|0.14|||ANCOVA|||LS Mean, 95 percent CI and P-values were obtained from an analysis of covariance (ANCOVA) model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.|
1728664|NCT00565812|3184814|Superiority or Other||Odds Ratio (OR)|0.774||||0.276|2-Sided|95.0|0.489|1.227|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.|
1728665|NCT00565812|3184814|Superiority or Other||Odds Ratio (OR)|0.583||||0.032|2-Sided|95.0|0.356|0.955|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.|
1728666|NCT00565812|3184814|Superiority or Other||Odds Ratio (OR)|0.893||||0.634|2-Sided|95.0|0.56|1.423|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.|
1728667|NCT00565812|3184814|Superiority or Other||Odds Ratio (OR)|0.704||||0.168|2-Sided|95.0|0.428|1.16|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.|
1728668|NCT00565812|3184815|Superiority or Other||Odds Ratio (OR)|1.154||||0.591|2-Sided|95.0|0.685|1.942|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.|
1728669|NCT00565812|3184815|Superiority or Other||Odds Ratio (OR)|0.787||||0.406|2-Sided|95.0|0.448|1.384|||Regression, Logistic|||Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.|
1728670|NCT00565812|3184815|Superiority or Other||Odds Ratio (OR)|1.273||||0.406|2-Sided|95.0|0.721|2.247|||Regression, Logistic|||Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.|
1728671|NCT00565812|3184815|Superiority or Other||Odds Ratio (OR)|0.952||||0.875|2-Sided|95.0|0.516|1.756|||Regression, Logistic|||Month 12; Odds ratio (OR), 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.|
1728672|NCT00565812|3184822|Superiority or Other||LS mean difference|0.87|Standard Error of the Mean|0.68||0.204|2-Sided|95.0|-0.47|2.21|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728673|NCT00565812|3184822|Superiority or Other||LS mean difference|1.02|Standard Error of the Mean|0.69||0.142|2-Sided|95.0|-0.34|2.37|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728674|NCT00565812|3184822|Superiority or Other||LS mean difference|0.53|Standard Error of the Mean|0.62||0.391|2-Sided|95.0|-0.68|1.75|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728675|NCT00565812|3184822|Superiority or Other||LS mean difference|1.42|Standard Error of the Mean|0.62||0.023|2-Sided|95.0|0.19|2.65|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728676|NCT00565812|3184823|Superiority or Other||LS mean difference|-0.37|Standard Error of the Mean|0.56||0.514|2-Sided|95.0|-1.47|0.74|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728677|NCT00565812|3184823|Superiority or Other||LS Mean Difference|-0.68|Standard Error of the Mean|0.57||0.228|2-Sided|95.0|-1.8|0.43|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728678|NCT00565812|3184823|Superiority or Other||LS Mean Difference|0.15|Standard Error of the Mean|0.5||0.764|2-Sided|95.0|-0.84|1.14|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728679|NCT00565812|3184823|Superiority or Other||LS Mean Difference|-0.2|Standard Error of the Mean|0.51||0.701|2-Sided|95.0|-1.19|0.8|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728680|NCT00565812|3184824|Superiority or Other||LS mean difference|0.5|Standard Error of the Mean|0.67||0.45|2-Sided|95.0|-0.8|1.81|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728681|NCT00565812|3184824|Superiority or Other||LS mean difference|0.98|Standard Error of the Mean|0.67||0.143|2-Sided|95.0|-0.33|2.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728682|NCT00565812|3184824|Superiority or Other||LS mean difference|0.76|Standard Error of the Mean|0.61||0.213|2-Sided|95.0|-0.44|1.96|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728683|NCT00565812|3184824|Superiority or Other||LS mean difference|1.17|Standard Error of the Mean|0.62||0.058|2-Sided|95.0|-0.04|2.38|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728684|NCT00565812|3184825|Superiority or Other||LS mean difference|0.78|Standard Error of the Mean|0.77||0.31|2-Sided|95.0|-0.73|2.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1729174|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-0.86|||<|0.0001|2-Sided|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64|
1728685|NCT00565812|3184825|Superiority or Other||LS mean difference|0.26|Standard Error of the Mean|0.78||0.743|2-Sided|95.0|-1.27|1.78|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728686|NCT00565812|3184825|Superiority or Other||LS mean difference|0.44|Standard Error of the Mean|0.7||0.524|2-Sided|95.0|-0.93|1.82|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728687|NCT00565812|3184825|Superiority or Other||LS mean difference|1.06|Standard Error of the Mean|0.71||0.133|2-Sided|95.0|-0.32|2.44|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728688|NCT00565812|3184826|Superiority or Other||LS mean difference|1.04|Standard Error of the Mean|0.66||0.117|2-Sided|95.0|-0.26|2.34|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728689|NCT00565812|3184826|Superiority or Other||LS mean difference|1.01|Standard Error of the Mean|0.67||0.132|2-Sided|95.0|-0.3|2.32|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728690|NCT00565812|3184826|Superiority or Other||LS mean difference|0.43|Standard Error of the Mean|0.6||0.48|2-Sided|95.0|-0.76|1.61|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728691|NCT00565812|3184826|Superiority or Other||LS mean difference|1.33|Standard Error of the Mean|0.61||0.03|2-Sided|95.0|0.13|2.52|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728692|NCT00565812|3184827|Superiority or Other||LS mean difference|-0.01|Standard Error of the Mean|0.59||0.986|2-Sided|95.0|-1.16|1.14|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728693|NCT00565812|3184827|Superiority or Other||LS mean difference|0.33|Standard Error of the Mean|0.59||0.575|2-Sided|95.0|-0.83|1.49|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728694|NCT00565812|3184827|Superiority or Other||LS mean difference|-0.01|Standard Error of the Mean|0.53||0.98|2-Sided|95.0|-1.06|1.03|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728695|NCT00565812|3184827|Superiority or Other||LS mean difference|0.67|Standard Error of the Mean|0.54||0.214|2-Sided|95.0|-0.39|1.72|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728696|NCT00565812|3184828|Superiority or Other||LS mean difference|-0.43|Standard Error of the Mean|0.53||0.425|2-Sided|95.0|-1.48|0.62|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728697|NCT00565812|3184828|Superiority or Other||LS mean difference|-0.27|Standard Error of the Mean|0.54||0.615|2-Sided|95.0|-1.33|0.79|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728698|NCT00565812|3184828|Superiority or Other||LS mean difference|0.49|Standard Error of the Mean|0.48||0.308|2-Sided|95.0|-0.45|1.42|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728860|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|0.87|||<|0.5763|2-Sided|95.0|0.4|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1729615|NCT00560417|3185576|Superiority or Other|||||||0.177||||||p-value is for Endpoint (LOCF): HbA1c <7.0%|Fisher Exact||||
1728699|NCT00565812|3184828|Superiority or Other||LS mean difference|0.23|Standard Error of the Mean|0.48||0.632|2-Sided|95.0|-0.71|1.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728700|NCT00565812|3184829|Superiority or Other||LS mean difference|0.47|Standard Error of the Mean|0.65||0.469|2-Sided|95.0|-0.8|1.74|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728701|NCT00565812|3184829|Superiority or Other||LS mean difference|-0.27|Standard Error of the Mean|0.65||0.677|2-Sided|95.0|-1.56|1.01|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728702|NCT00565812|3184829|Superiority or Other||LS mean difference|0.24|Standard Error of the Mean|0.58||0.687|2-Sided|95.0|-0.91|1.38|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728703|NCT00565812|3184829|Superiority or Other||LS mean difference|0.32|Standard Error of the Mean|0.59||0.587|2-Sided|95.0|-0.84|1.48|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728704|NCT00565812|3184830|Superiority or Other||LS mean difference|-0.12|Standard Error of the Mean|0.62||0.841|2-Sided|95.0|-1.34|1.09|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728705|NCT00565812|3184830|Superiority or Other||LS mean difference|-0.29|Standard Error of the Mean|0.62||0.647|2-Sided|95.0|-1.51|0.94|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728706|NCT00565812|3184830|Superiority or Other||LS mean difference|0.36|Standard Error of the Mean|0.58||0.528|2-Sided|95.0|-0.77|1.5|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728707|NCT00565812|3184830|Superiority or Other||LS mean difference|0.07|Standard Error of the Mean|0.58||0.9|2-Sided|95.0|-1.07|1.21|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728708|NCT00565812|3184831|Superiority or Other||LS mean difference|-0.26|Standard Error of the Mean|0.64||0.681|2-Sided|95.0|-1.52|1.0|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728709|NCT00565812|3184831|Superiority or Other||LS mean difference|-0.23|Standard Error of the Mean|0.65||0.726|2-Sided|95.0|-1.5|1.04|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728710|NCT00565812|3184831|Superiority or Other||LS mean difference|0.07|Standard Error of the Mean|0.56||0.906|2-Sided|95.0|-1.04|1.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728711|NCT00565812|3184831|Superiority or Other||LS mean difference|0.04|Standard Error of the Mean|0.57||0.938|2-Sided|95.0|-1.07|1.16|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728712|NCT00565812|3184832|Superiority or Other||LS mean difference|0.82|Standard Error of the Mean|1.15||0.475|2-Sided|95.0|-1.44|3.09|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728861|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|3.35|||<|0.002|2-Sided|95.0|1.3|8.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1729616|NCT00560417|3185576|Superiority or Other|||||||0.071||||||p-value is for Week 24: HbA1c <=6.5%|Fisher Exact||||
1728713|NCT00565812|3184832|Superiority or Other||LS mean difference|1.36|Standard Error of the Mean|1.15||0.237|2-Sided|95.0|-0.9|3.63|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728714|NCT00565812|3184832|Superiority or Other||LS mean difference|0.2|Standard Error of the Mean|1.11||0.856|2-Sided|95.0|-1.97|2.37|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728715|NCT00565812|3184832|Superiority or Other||LS mean difference|0.05|Standard Error of the Mean|1.11||0.962|2-Sided|95.0|-2.12|2.22|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728716|NCT00565812|3184832|Superiority or Other||LS mean difference|0.01|Standard Error of the Mean|0.98||0.988|2-Sided|95.0|-1.9|1.93|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*(visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728717|NCT00565812|3184832|Superiority or Other||LS mean difference|0.61|Standard Error of the Mean|0.98||0.537|2-Sided|95.0|-1.32|2.54|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728718|NCT00565812|3184832|Superiority or Other||LS mean difference|0.46|Standard Error of the Mean|0.97||0.638|2-Sided|95.0|-1.44|2.35|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728719|NCT00565812|3184832|Superiority or Other||LS mean difference|1.36|Standard Error of the Mean|0.96||0.16|2-Sided|95.0|-0.54|3.25|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728720|NCT00565812|3184832|Superiority or Other||LS mean difference|0.7|Standard Error of the Mean|0.82||0.395|2-Sided|95.0|-0.91|2.3|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728721|NCT00565812|3184832|Superiority or Other||LS mean difference|1.67|Standard Error of the Mean|0.81||0.039|2-Sided|95.0|0.08|3.26|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLGU*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728722|NCT00565812|3184833|Superiority or Other||LS mean difference|0.75|Standard Error of the Mean|0.73||0.303|2-Sided|95.0|-0.68|2.18|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728723|NCT00565812|3184833|Superiority or Other||LS mean difference|0.73|Standard Error of the Mean|0.73||0.318|2-Sided|95.0|-0.7|2.16|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728724|NCT00565812|3184833|Superiority or Other||LS mean difference|0.56|Standard Error of the Mean|0.72||0.433|2-Sided|95.0|-0.84|1.97|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728725|NCT00565812|3184833|Superiority or Other||LS mean difference|0.42|Standard Error of the Mean|0.72||0.56|2-Sided|95.0|-1.0|1.84|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728726|NCT00565812|3184833|Superiority or Other||LS mean difference|0.26|Standard Error of the Mean|0.62||0.675|2-Sided|95.0|-0.96|1.49|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728862|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|3.36|||<|0.002|2-Sided|95.0|1.2|9.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1729617|NCT00560417|3185576|Superiority or Other|||||||0.161||||||p-value is for Week 24: HbA1c <7.0%|Fisher Exact||||
1728727|NCT00565812|3184833|Superiority or Other||LS mean difference|0.19|Standard Error of the Mean|0.63||0.765|2-Sided|95.0|-1.05|1.43|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728728|NCT00565812|3184833|Superiority or Other||LS mean difference|0.26|Standard Error of the Mean|0.62||0.672|2-Sided|95.0|-0.95|1.47|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728729|NCT00565812|3184833|Superiority or Other||LS mean difference|0.89|Standard Error of the Mean|0.62||0.153|2-Sided|95.0|-0.33|2.11|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728730|NCT00565812|3184833|Superiority or Other||LS mean difference|0.52|Standard Error of the Mean|0.54||0.335|2-Sided|95.0|-0.53|1.57|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728731|NCT00565812|3184833|Superiority or Other||LS mean difference|0.97|Standard Error of the Mean|0.53||0.069|2-Sided|95.0|-0.07|2.02|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728732|NCT00565812|3184834|Superiority or Other||LS mean difference|-0.38|Standard Error of the Mean|1.44||0.794|2-Sided|95.0|-3.19|2.44|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728733|NCT00565812|3184834|Superiority or Other||LS mean difference|0.01|Standard Error of the Mean|1.45||0.993|2-Sided|95.0|-2.82|2.85|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728734|NCT00565812|3184834|Superiority or Other||LS mean difference|0.52|Standard Error of the Mean|1.45||0.72|2-Sided|95.0|-2.32|3.36|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728735|NCT00565812|3184834|Superiority or Other||LS mean difference|-1.74|Standard Error of the Mean|1.46||0.233|2-Sided|95.0|-4.61|1.12|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728736|NCT00565812|3184834|Superiority or Other||LS mean difference|-0.1|Standard Error of the Mean|1.32||0.939|2-Sided|95.0|-2.69|2.48|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728737|NCT00565812|3184834|Superiority or Other||LS mean difference|-1.86|Standard Error of the Mean|1.33||0.163|2-Sided|95.0|-4.46|0.75|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728738|NCT00565812|3184834|Superiority or Other||LS mean difference|-0.66|Standard Error of the Mean|1.27||0.604|2-Sided|95.0|-3.15|1.83|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728739|NCT00565812|3184834|Superiority or Other||LS mean difference|-1.33|Standard Error of the Mean|1.27||0.296|2-Sided|95.0|-3.82|1.16|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728740|NCT00565812|3184834|Superiority or Other||LS mean difference|-0.49|Standard Error of the Mean|1.16||0.67|2-Sided|95.0|-2.76|1.78|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728863|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|0.98|||<|0.9055|2-Sided|95.0|0.5|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1729618|NCT00560417|3185576|Superiority or Other|||||||0.269||||||p-value is for Week 18: HbA1c <=6.5%|Fisher Exact||||
1728741|NCT00565812|3184834|Superiority or Other||LS mean difference|0.58|Standard Error of the Mean|1.16||0.613|2-Sided|95.0|-1.68|2.85|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728742|NCT00565812|3184835|Superiority or Other||LS mean difference|-0.79|Standard Error of the Mean|1.44||0.585|2-Sided|95.0|-3.62|2.04|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728743|NCT00565812|3184835|Superiority or Other||LS mean difference|1.12|Standard Error of the Mean|1.45||0.443|2-Sided|95.0|-1.73|3.97|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728744|NCT00565812|3184835|Superiority or Other||LS mean difference|-0.48|Standard Error of the Mean|1.42||0.737|2-Sided|95.0|-3.25|2.3|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728745|NCT00565812|3184835|Superiority or Other||LS mean difference|-1.24|Standard Error of the Mean|1.43||0.387|2-Sided|95.0|-4.04|1.57|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728746|NCT00565812|3184835|Superiority or Other||LS mean difference|-0.3|Standard Error of the Mean|1.32||0.823|2-Sided|95.0|-2.89|2.3|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728747|NCT00565812|3184835|Superiority or Other||LS mean difference|-0.59|Standard Error of the Mean|1.33||0.659|2-Sided|95.0|-3.2|2.03|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728748|NCT00565812|3184835|Superiority or Other||LS mean difference|-0.03|Standard Error of the Mean|1.26||0.979|2-Sided|95.0|-2.51|2.44|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728749|NCT00565812|3184835|Superiority or Other||LS mean difference|0.67|Standard Error of the Mean|1.26||0.596|2-Sided|95.0|-1.81|3.15|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728750|NCT00565812|3184835|Superiority or Other||LS mean difference|-0.81|Standard Error of the Mean|1.2||0.5|2-Sided|95.0|-3.16|1.54|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728751|NCT00565812|3184835|Superiority or Other||LS mean difference|0.13|Standard Error of the Mean|1.2||0.911|2-Sided|95.0|-2.22|2.49|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728752|NCT00565812|3184836|Superiority or Other||LS mean difference|-0.47|Standard Error of the Mean|1.38||0.732|2-Sided|95.0|-3.18|2.23|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728753|NCT00565812|3184836|Superiority or Other||LS mean difference|0.58|Standard Error of the Mean|1.39||0.676|2-Sided|95.0|-2.14|3.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728754|NCT00565812|3184836|Superiority or Other||LS mean difference|0.13|Standard Error of the Mean|1.37||0.925|2-Sided|95.0|-2.56|2.82|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728864|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|2.8|||<|0.0038|2-Sided|95.0|1.0|7.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1729619|NCT00560417|3185576|Superiority or Other|||||||0.012||||||p-value is for Week 18: HbA1c <7.0%|Fisher Exact||||
1728755|NCT00565812|3184836|Superiority or Other||LS mean difference|-1.44|Standard Error of the Mean|1.38||0.299|2-Sided|95.0|-4.16|1.28|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728756|NCT00565812|3184836|Superiority or Other||LS mean difference|-0.05|Standard Error of the Mean|1.26||0.966|2-Sided|95.0|-2.52|2.41|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728757|NCT00565812|3184836|Superiority or Other||LS mean difference|-1.22|Standard Error of the Mean|1.27||0.335|2-Sided|95.0|-3.71|1.26|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728758|NCT00565812|3184836|Superiority or Other||LS mean difference|-0.29|Standard Error of the Mean|1.21||0.811|2-Sided|95.0|-2.66|2.08|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728759|NCT00565812|3184836|Superiority or Other||LS mean difference|-0.41|Standard Error of the Mean|1.21||0.736|2-Sided|95.0|-2.77|1.96|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728760|NCT00565812|3184836|Superiority or Other||LS mean difference|-0.53|Standard Error of the Mean|1.11||0.632|2-Sided|95.0|-2.7|1.64|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728761|NCT00565812|3184836|Superiority or Other||LS mean difference|0.37|Standard Error of the Mean|1.11||0.738|2-Sided|95.0|-1.8|2.55|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728762|NCT00565812|3184837|Superiority or Other||LS mean difference|-0.65|Standard Error of the Mean|1.57||0.679|2-Sided|95.0|-3.73|2.43|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728763|NCT00565812|3184837|Superiority or Other||LS mean difference|1.62|Standard Error of the Mean|1.58||0.304|2-Sided|95.0|-1.47|4.71|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728764|NCT00565812|3184837|Superiority or Other||LS mean difference|0.97|Standard Error of the Mean|1.61||0.547|2-Sided|95.0|-2.18|4.12|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728765|NCT00565812|3184837|Superiority or Other||LS mean difference|0.15|Standard Error of the Mean|1.62||0.927|2-Sided|95.0|-3.03|3.33|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728766|NCT00565812|3184837|Superiority or Other||LS mean difference|0.1|Standard Error of the Mean|1.48||0.947|2-Sided|95.0|-2.81|3.01|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728767|NCT00565812|3184837|Superiority or Other||LS mean difference|0.24|Standard Error of the Mean|1.49||0.872|2-Sided|95.0|-2.69|3.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728768|NCT00565812|3184837|Superiority or Other||LS mean difference|0.06|Standard Error of the Mean|1.44||0.964|2-Sided|95.0|-2.75|2.88|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728865|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|3.29|||<|0.0036|2-Sided|95.0|1.3|8.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1729620|NCT00560417|3185576|Superiority or Other|||||||0.511||||||p-value is for Week 12: HbA1c <=6.5%|Fisher Exact||||
1728769|NCT00565812|3184837|Superiority or Other||LS mean difference|0.73|Standard Error of the Mean|1.44||0.613|2-Sided|95.0|-2.09|3.55|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728770|NCT00565812|3184837|Superiority or Other||LS mean difference|0.01|Standard Error of the Mean|1.36||0.997|2-Sided|95.0|-2.67|2.68|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728771|NCT00565812|3184837|Superiority or Other||LS mean difference|1.68|Standard Error of the Mean|1.37||0.22|2-Sided|95.0|-1.0|4.36|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728772|NCT00565812|3184838|Superiority or Other||LS mean difference|0.021|Standard Error of the Mean|0.054||0.7|2-Sided|95.0|-0.085|0.127|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728773|NCT00565812|3184838|Superiority or Other||LS mean difference|0.025|Standard Error of the Mean|0.054||0.652|2-Sided|95.0|-0.082|0.131|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728774|NCT00565812|3184838|Superiority or Other||LS mean difference|-0.019|Standard Error of the Mean|0.052||0.714|2-Sided|95.0|-0.122|0.084|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728775|NCT00565812|3184838|Superiority or Other||LS mean difference|-0.01|Standard Error of the Mean|0.053||0.848|2-Sided|95.0|-0.114|0.094|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728776|NCT00565812|3184838|Superiority or Other||LS mean difference|-0.103|Standard Error of the Mean|0.05||0.038|2-Sided|95.0|-0.201|-0.006|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728777|NCT00565812|3184838|Superiority or Other||LS mean difference|-0.064|Standard Error of the Mean|0.05||0.201|2-Sided|95.0|-0.163|0.034|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728778|NCT00565812|3184838|Superiority or Other||LS mean difference|-0.1|Standard Error of the Mean|0.047||0.033|2-Sided|95.0|-0.191|-0.008|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728779|NCT00565812|3184838|Superiority or Other||LS mean difference|-0.013|Standard Error of the Mean|0.047||0.776|2-Sided|95.0|-0.105|0.078|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728780|NCT00565812|3184838|Superiority or Other||LS mean difference|-0.009|Standard Error of the Mean|0.044||0.837|2-Sided|95.0|-0.096|0.078|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728781|NCT00565812|3184838|Superiority or Other||LS mean difference|0.008|Standard Error of the Mean|0.044||0.849|2-Sided|95.0|-0.078|0.095|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728782|NCT00565812|3184839|Superiority or Other||LS mean difference|-0.023|Standard Error of the Mean|0.057||0.69|2-Sided|95.0|-0.135|0.089|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728866|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|1.01|||<|0.977|2-Sided|95.0|0.5|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1729621|NCT00560417|3185576|Superiority or Other|||||||0.561||||||p-value is for Week 12: HbA1c <7.0%|Fisher Exact||||
1728783|NCT00565812|3184839|Superiority or Other||LS mean difference|-0.008|Standard Error of the Mean|0.057||0.883|2-Sided|95.0|-0.121|0.104|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728784|NCT00565812|3184839|Superiority or Other||LS mean difference|-0.05|Standard Error of the Mean|0.057||0.376|2-Sided|95.0|-0.162|0.061|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728785|NCT00565812|3184839|Superiority or Other||LS mean difference|-0.019|Standard Error of the Mean|0.057||0.739|2-Sided|95.0|-0.132|0.094|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728786|NCT00565812|3184839|Superiority or Other||LS mean difference|-0.036|Standard Error of the Mean|0.052||0.49|2-Sided|95.0|-0.137|0.066|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728787|NCT00565812|3184839|Superiority or Other||LS mean difference|-0.035|Standard Error of the Mean|0.052||0.508|2-Sided|95.0|-0.137|0.068|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728788|NCT00565812|3184839|Superiority or Other||LS mean difference|-0.083|Standard Error of the Mean|0.049||0.089|2-Sided|95.0|-0.18|0.013|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728789|NCT00565812|3184839|Superiority or Other||LS mean difference|-0.05|Standard Error of the Mean|0.049||0.308|2-Sided|95.0|-0.146|0.046|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728790|NCT00565812|3184839|Superiority or Other||LS mean difference|-0.046|Standard Error of the Mean|0.048||0.33|2-Sided|95.0|-0.14|0.047|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728791|NCT00565812|3184839|Superiority or Other||LS mean difference|0.001|Standard Error of the Mean|0.048||0.984|2-Sided|95.0|-0.093|0.095|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728792|NCT00565812|3184840|Superiority or Other||LS mean difference|-0.39|Standard Error of the Mean|1.56||0.8|2-Sided|95.0|-3.45|2.66|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728793|NCT00565812|3184840|Superiority or Other||LS mean difference|-0.2|Standard Error of the Mean|1.57||0.901|2-Sided|95.0|-3.27|2.88|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728794|NCT00565812|3184840|Superiority or Other||LS mean difference|1.14|Standard Error of the Mean|1.56||0.464|2-Sided|95.0|-1.92|4.2|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728795|NCT00565812|3184840|Superiority or Other||LS mean difference|-0.21|Standard Error of the Mean|1.58||0.896|2-Sided|95.0|-3.3|2.88|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728796|NCT00565812|3184840|Superiority or Other||LS mean difference|1.18|Standard Error of the Mean|1.52||0.44|2-Sided|95.0|-1.81|4.17|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728867|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|3.02|||<|0.0035|2-Sided|95.0|1.2|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1729872|NCT00556322|3186246|Superiority or Other||Hazard Ratio, log|0.95||||0.8398|2-Sided|95.0|0.55|1.62|||Log Rank|||Comparison of EGFR negative populations|
1728797|NCT00565812|3184840|Superiority or Other||LS mean difference|1.63|Standard Error of the Mean|1.53||0.288|2-Sided|95.0|-1.38|4.64|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728798|NCT00565812|3184840|Superiority or Other||LS mean difference|1.26|Standard Error of the Mean|1.41||0.374|2-Sided|95.0|-1.51|4.02|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728799|NCT00565812|3184840|Superiority or Other||LS mean difference|0.8|Standard Error of the Mean|1.41||0.569|2-Sided|95.0|-1.97|3.57|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728800|NCT00565812|3184840|Superiority or Other||LS mean difference|1.11|Standard Error of the Mean|1.36||0.415|2-Sided|95.0|-1.56|3.78|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728801|NCT00565812|3184840|Superiority or Other||LS mean difference|2.34|Standard Error of the Mean|1.36||0.086|2-Sided|95.0|-0.33|5.01|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728802|NCT00565812|3184841|Superiority or Other||LS mean difference|-0.81|Standard Error of the Mean|0.84||0.333|2-Sided|95.0|-2.45|0.83|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728803|NCT00565812|3184841|Superiority or Other||LS mean difference|0.1|Standard Error of the Mean|0.84||0.901|2-Sided|95.0|-1.55|1.76|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728804|NCT00565812|3184841|Superiority or Other||LS mean difference|0.28|Standard Error of the Mean|0.82||0.73|2-Sided|95.0|-1.33|1.9|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728805|NCT00565812|3184841|Superiority or Other||LS mean difference|-0.34|Standard Error of the Mean|0.83||0.68|2-Sided|95.0|-1.97|1.29|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728806|NCT00565812|3184841|Superiority or Other||LS mean difference|-0.06|Standard Error of the Mean|0.76||0.938|2-Sided|95.0|-1.55|1.43|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728807|NCT00565812|3184841|Superiority or Other||LS mean difference|0.48|Standard Error of the Mean|0.76||0.532|2-Sided|95.0|-1.02|1.97|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728808|NCT00565812|3184841|Superiority or Other||LS mean difference|0.73|Standard Error of the Mean|0.69||0.294|2-Sided|95.0|-0.63|2.09|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728809|NCT00565812|3184841|Superiority or Other||LS mean difference|0.16|Standard Error of the Mean|0.69||0.821|2-Sided|95.0|-1.21|1.52|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728810|NCT00565812|3184841|Superiority or Other||LS mean difference|0.17|Standard Error of the Mean|0.62||0.789|2-Sided|95.0|-1.05|1.38|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728868|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|1.87|||<|0.0903|2-Sided|95.0|0.8|4.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1729873|NCT00556322|3186246|Superiority or Other||Hazard Ratio (HR)|0.94||||0.6198|2-Sided|95.0|0.72|1.21|||Log Rank|||Comparison of EGFR positive populations|
1728811|NCT00565812|3184841|Superiority or Other||LS mean difference|0.34|Standard Error of the Mean|0.62||0.586|2-Sided|95.0|-0.88|1.55|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728812|NCT00565812|3184842|Superiority or Other||LS mean difference|-0.21|Standard Error of the Mean|0.12||0.086|2-Sided|95.0|-0.45|0.03|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728813|NCT00565812|3184842|Superiority or Other||LS mean difference|0.0|Standard Error of the Mean|0.12||1|2-Sided|95.0|-0.24|0.24|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728814|NCT00565812|3184842|Superiority or Other||LS mean difference|-0.1|Standard Error of the Mean|0.11||0.391|2-Sided|95.0|-0.32|0.13|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728815|NCT00565812|3184842|Superiority or Other||LS mean difference|-0.06|Standard Error of the Mean|0.12||0.612|2-Sided|95.0|-0.28|0.17|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728816|NCT00565812|3184842|Superiority or Other||LS mean difference|0.05|Standard Error of the Mean|0.11||0.658|2-Sided|95.0|-0.17|0.27|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728817|NCT00565812|3184842|Superiority or Other||LS mean difference|0.02|Standard Error of the Mean|0.11||0.857|2-Sided|95.0|-0.2|0.24|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728818|NCT00565812|3184842|Superiority or Other||LS mean difference|0.0|Standard Error of the Mean|0.1||0.988|2-Sided|95.0|-0.2|0.2|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG x visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728819|NCT00565812|3184842|Superiority or Other||LS mean difference|-0.02|Standard Error of the Mean|0.1||0.818|2-Sided|95.0|-0.22|0.18|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728820|NCT00565812|3184842|Superiority or Other||LS mean difference|-0.05|Standard Error of the Mean|0.09||0.582|2-Sided|95.0|-0.24|0.13|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728821|NCT00565812|3184842|Superiority or Other||LS mean difference|0.01|Standard Error of the Mean|0.09||0.904|2-Sided|95.0|-0.17|0.2|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728822|NCT00565812|3184843|Superiority or Other||LS mean difference|-0.21|Standard Error of the Mean|0.26||0.423|2-Sided|95.0|-0.71|0.3|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728823|NCT00565812|3184843|Superiority or Other||LS mean difference|-0.16|Standard Error of the Mean|0.26||0.54|2-Sided|95.0|-0.66|0.35|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728824|NCT00565812|3184843|Superiority or Other||LS mean difference|-0.25|Standard Error of the Mean|0.25||0.328|2-Sided|95.0|-0.74|0.25|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728825|NCT00565812|3184843|Superiority or Other||LS mean difference|-0.23|Standard Error of the Mean|0.25||0.365|2-Sided|95.0|-0.73|0.27|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728826|NCT00565812|3184843|Superiority or Other||LS mean difference|-0.15|Standard Error of the Mean|0.23||0.528|2-Sided|95.0|-0.6|0.31|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728827|NCT00565812|3184843|Superiority or Other||LS mean difference|-0.02|Standard Error of the Mean|0.24||0.916|2-Sided|95.0|-0.49|0.44|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728828|NCT00565812|3184843|Superiority or Other||LS mean difference|0.1|Standard Error of the Mean|0.22||0.648|2-Sided|95.0|-0.32|0.52|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728829|NCT00565812|3184843|Superiority or Other||LS mean difference|0.02|Standard Error of the Mean|0.22||0.938|2-Sided|95.0|-0.41|0.44|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group* visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728830|NCT00565812|3184843|Superiority or Other||LS mean difference|-0.04|Standard Error of the Mean|0.19||0.853|2-Sided|95.0|-0.42|0.35|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728831|NCT00565812|3184843|Superiority or Other||LS mean difference|0.08|Standard Error of the Mean|0.19||0.683|2-Sided|95.0|-0.3|0.46|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group* visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728832|NCT00565812|3184844|Superiority or Other||LS mean difference|-1.23|Standard Error of the Mean|1.17||0.292|2-Sided|95.0|-3.53|1.06|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728833|NCT00565812|3184844|Superiority or Other||LS mean difference|-0.07|Standard Error of the Mean|1.17||0.95|2-Sided|95.0|-2.37|2.23|||Mixed Models Analysis|||Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728834|NCT00565812|3184844|Superiority or Other||LS mean difference|-0.03|Standard Error of the Mean|1.14||0.98|2-Sided|95.0|-2.26|2.21|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728835|NCT00565812|3184844|Superiority or Other||LS mean difference|-0.64|Standard Error of the Mean|1.15||0.577|2-Sided|95.0|-2.89|1.61|||Mixed Models Analysis|||Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728836|NCT00565812|3184844|Superiority or Other||LS mean difference|-0.13|Standard Error of the Mean|1.05||0.902|2-Sided|95.0|-2.18|1.93|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728837|NCT00565812|3184844|Superiority or Other||LS mean difference|0.44|Standard Error of the Mean|1.05||0.678|2-Sided|95.0|-1.63|2.51|||Mixed Models Analysis|||Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728838|NCT00565812|3184844|Superiority or Other||LS mean difference|0.87|Standard Error of the Mean|0.96||0.365|2-Sided|95.0|-1.01|2.76|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728839|NCT00565812|3184844|Superiority or Other||LS mean difference|0.13|Standard Error of the Mean|0.96||0.893|2-Sided|95.0|-1.76|2.01|||Mixed Models Analysis|||Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728869|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|0.9|||<|0.8103|2-Sided|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1729622|NCT00560417|3185577|Superiority or Other||Mean Difference (Final Values)|0.22||||0.008|2-Sided|95.0|0.06|0.38||p-value is for Endpoint (LOCF) Change.|ANCOVA||||
1728840|NCT00565812|3184844|Superiority or Other||LS mean difference|0.05|Standard Error of the Mean|0.84||0.957|2-Sided|95.0|-1.61|1.7|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728841|NCT00565812|3184844|Superiority or Other||LS mean difference|0.4|Standard Error of the Mean|0.84||0.639|2-Sided|95.0|-1.26|2.05|||Mixed Models Analysis|||Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group*visit interaction, (collapsed) KLG, a (collapsed) KLG*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.|
1728842|NCT00565812|3184845|Superiority or Other||Difference in slopes|-0.007|Standard Error of the Mean|0.025||0.78|2-Sided|95.0|-0.056|0.042|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.|
1728843|NCT00565812|3184845|Superiority or Other||Difference in slopes|0.004|Standard Error of the Mean|0.026||0.881|2-Sided|95.0|-0.046|0.054|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.|
1728844|NCT00565812|3184846|Superiority or Other||Difference in slopes|0.022|Standard Error of the Mean|0.023||0.327|2-Sided|95.0|-0.022|0.067|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.|
1728845|NCT00565812|3184846|Superiority or Other||Difference in slopes|0.023|Standard Error of the Mean|0.023||0.312|2-Sided|95.0|-0.022|0.067|||Mixed Models Analysis|||Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.|
1728846|NCT00565812|3184847|Superiority or Other||Difference in Slopes|0.005|Standard Error of the Mean|0.017||0.754074|2-Sided|95.0|-0.029|0.04|||Mixed Models Analysis|||Slopes, 95 percent CI, P-values: MMRM with random intercept and slope for each participant, fixed effects for treatment group, time (years), treatment group*time interaction, (collapsed) KLG, KLG*time interaction, geographic region, gender, age, body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha=0.0499.|
1728847|NCT00565812|3184847|Superiority or Other||Difference in Slopes|0.012|Standard Error of the Mean|0.018||0.50877|2-Sided|95.0|-0.023|0.046|||Mixed Models Analysis|||Slopes, 95 percent confidence interval (CI), P-values: Random coefficients mixed-effects model for repeated measures (MMRM) with random intercept and slope for each participant,fixed effects for treatment group,time (years),treatment group*time interaction,(collapsed)Kellgren and Lawrence Grades (KLG), KLG*time interaction,geographic region,gender,age,body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha =0.0499.|
1728848|NCT00565617|3184882|Superiority or Other|||||||0.009|||||||ANOVA||||
1728849|NCT00565448|3184901|Superiority or Other|||||||1||||||The Fisher’s exact test was used to compare the CR proportions.|Fisher Exact|||There was no formal power calculation. A selection design was used to determine how many participants would be accrued to correctly select the treatment group with the best CR rate with 80% probability.|
1728850|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|3.62||||0.0001|2-Sided|95.0|1.6|8.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728851|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|1.12||||0.5025|2-Sided|95.0|0.6|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728852|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|3.53|||<|0.0001|2-Sided|95.0|1.6|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728853|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|3.56|||<|0.0003|2-Sided|95.0|1.5|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728854|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|1.03|||<|0.8553|2-Sided|95.0|0.6|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728855|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|3.28|||<|0.0002|2-Sided|95.0|1.4|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728856|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|3.52|||<|0.0001|2-Sided|95.0|1.4|9.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728857|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|0.83|||<|0.4828|2-Sided|95.0|0.4|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728858|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|3.21|||<|0.0004|2-Sided|95.0|1.2|8.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1729807|NCT00557245|3186053|Superiority or Other||||||<|0.02|||||||Mixed Models Analysis|Linear mixed effects model|||
1728870|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|1.53|||<|0.0797|2-Sided|95.0|0.6|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1728871|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|2.76|||<|0.0019|2-Sided|95.0|1.2|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728872|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|0.87|||<|0.6932|2-Sided|95.0|0.5|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728873|NCT00565409|3184903|Superiority or Other||Odds Ratio (OR)|2.14|||<|0.0089|2-Sided|95.0|0.9|5.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728874|NCT00565409|3184904|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 36|
1728875|NCT00565409|3184904|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 28|
1728876|NCT00565409|3184904|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 20|
1728877|NCT00565409|3184904|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 12|
1728878|NCT00565409|3184904|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 8|
1728879|NCT00565409|3184904|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 4|
1728880|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|3.23|||<|0.0001|2-Sided|95.0|1.9|5.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728881|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|1.25|||<|0.3231|2-Sided|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728882|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|3.45|||<|0.0001|2-Sided|95.0|2.0|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728883|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|3.44|||<|0.0001|2-Sided|95.0|1.9|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728884|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|1.21|||<|0.3535|2-Sided|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728885|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|3.53|||<|0.0001|2-Sided|95.0|2.0|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728886|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|3.67|||<|0.0001|2-Sided|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728887|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|1.06|||<|0.8766|2-Sided|95.0|0.7|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728888|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|3.26|||<|0.0001|2-Sided|95.0|1.8|5.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728889|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|3.38|||<|0.0001|2-Sided|95.0|1.9|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1728890|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|1.17|||<|0.4254|2-Sided|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1728891|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|3.78|||<|0.0001|2-Sided|95.0|2.2|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1728892|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|3.66|||<|0.0001|2-Sided|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1728893|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|0.95|||<|0.8185|2-Sided|95.0|0.6|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1728894|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|3.4|||<|0.0001|2-Sided|95.0|2.0|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1728895|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|4.01|||<|0.0001|2-Sided|95.0|2.3|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1728896|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|0.85|||<|0.4941|2-Sided|95.0|0.5|1.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1728897|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|3.24|||<|0.0001|2-Sided|95.0|1.9|5.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1728898|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|1.77|||<|0.0174|2-Sided|95.0|1.1|3.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1728899|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|1.02|||<|0.8675|2-Sided|95.0|0.6|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1728900|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|1.76|||<|0.0147|2-Sided|95.0|1.0|3.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1728901|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|1.02|||<|0.916|2-Sided|95.0|0.7|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728902|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|1.48|||<|0.063|2-Sided|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728903|NCT00565409|3184905|Superiority or Other||Odds Ratio (OR)|1.49|||<|0.0575|2-Sided|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728904|NCT00565409|3184906|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||week 36|
1728905|NCT00565409|3184906|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 28|
1728906|NCT00565409|3184906|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 20|
1728907|NCT00565409|3184906|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 12|
1728908|NCT00565409|3184906|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 8|
1728909|NCT00565409|3184906|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 4|
1728910|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|3.83|||<|0.0001|2-Sided|95.0|2.5|5.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728911|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|1.23|||<|0.2824|2-Sided|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728912|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|4.53|||<|0.0001|2-Sided|95.0|2.9|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728913|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|3.54|||<|0.0001|2-Sided|95.0|2.3|5.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728914|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|1.25|||<|0.4014|2-Sided|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728915|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|4.32|||<|0.0001|2-Sided|95.0|2.7|6.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728916|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|3.03|||<|0.0001|2-Sided|95.0|2.0|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728917|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|1.47|||<|0.0658|2-Sided|95.0|1.0|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728918|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|4.8|||<|0.0001|2-Sided|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728919|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|3.16|||<|0.0001|2-Sided|95.0|2.0|4.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1728920|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|1.22|||<|0.4919|2-Sided|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1728921|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|3.83|||<|0.0001|2-Sided|95.0|2.4|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1728922|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|3.15|||<|0.0001|2-Sided|95.0|2.0|4.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1728923|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|1.32|||<|0.2454|2-Sided|95.0|0.9|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1728924|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|4.2|||<|0.0001|2-Sided|95.0|2.7|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1728925|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|2.95|||<|0.0001|2-Sided|95.0|1.9|4.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1728926|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|0.97|||<|0.9225|2-Sided|95.0|0.6|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1728927|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|2.79|||<|0.0001|2-Sided|95.0|1.8|4.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1728928|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|1.92|||<|0.0013|2-Sided|95.0|1.3|2.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1728929|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|1.11|||<|0.5511|2-Sided|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1728930|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|2.16|||<|0.0003|2-Sided|95.0|1.4|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1728931|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|0.85|||<|0.4348|2-Sided|95.0|0.5|1.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728932|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|1.41|||<|0.1055|2-Sided|95.0|0.9|2.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728933|NCT00565409|3184907|Superiority or Other||Odds Ratio (OR)|1.2|||<|0.5263|2-Sided|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728934|NCT00565409|3184908|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 36|
1728935|NCT00565409|3184908|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 28|
1728936|NCT00565409|3184908|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 20|
1728937|NCT00565409|3184908|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 12|
1728938|NCT00565409|3184908|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 8|
1728939|NCT00565409|3184908|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 4|
1728940|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|3.03|||<|0.0001|2-Sided|95.0|2.0|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728941|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|0.95|||<|0.7837|2-Sided|95.0|0.6|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728942|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|2.85|||<|0.0001|2-Sided|95.0|1.8|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728943|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|3.8|||<|0.0001|2-Sided|95.0|2.4|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728944|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|1.13|||<|0.6076|2-Sided|95.0|0.7|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728945|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|4.41|||<|0.0001|2-Sided|95.0|2.7|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728946|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|3.27|||<|0.0001|2-Sided|95.0|2.1|5.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728947|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|1.2|||<|0.3037|2-Sided|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728948|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|4.28|||<|0.0001|2-Sided|95.0|2.6|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728949|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|2.96|||<|0.0001|2-Sided|95.0|1.9|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1728950|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|1.23|||<|0.4509|2-Sided|95.0|0.8|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1728951|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|3.59|||<|0.0001|2-Sided|95.0|2.3|5.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1728952|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|2.98|||<|0.0001|2-Sided|95.0|1.9|4.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1728953|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|1.05|||<|0.9599|2-Sided|95.0|0.6|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1728954|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|3.03|||<|0.0001|2-Sided|95.0|1.9|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1728955|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|3.04|||<|0.0001|2-Sided|95.0|1.9|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1728956|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|1.09|||<|0.7374|2-Sided|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1728957|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|3.25|||<|0.0001|2-Sided|95.0|2.0|5.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1728958|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|2.13|||<|0.0008|2-Sided|95.0|1.3|3.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1728959|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|0.92|||<|0.8308||95.0|0.6|0.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1728960|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|1.98|||<|0.0024|2-Sided|95.0|1.2|3.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1728961|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|0.76|||<|0.3648|2-Sided|95.0|0.4|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728962|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|1.1|||<|0.4967|2-Sided|95.0|0.6|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728963|NCT00565409|3184909|Superiority or Other||Odds Ratio (OR)|0.83|||<|0.6006|2-Sided|95.0|0.4|1.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728964|NCT00565409|3184910|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 36|
1728965|NCT00565409|3184910|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 28|
1728966|NCT00565409|3184910|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 20|
1728967|NCT00565409|3184910|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 12|
1728968|NCT00565409|3184910|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 8|
1728969|NCT00565409|3184910|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 4|
1728970|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|4.19|||<|0.0001|2-Sided|95.0|2.5|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728971|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|1.06|||<|0.4471|2-Sided|95.0|0.5|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728972|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|4.81|||<|0.0001|2-Sided|95.0|2.7|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1728973|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|4.59|||<|0.0001|2-Sided|95.0|2.7|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728974|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|1.21|||<|0.2825|2-Sided|95.0|0.6|2.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728975|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|6.44|||<|0.0001|2-Sided|95.0|3.4|12.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80|
1728976|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|4.92|||<|0.0001|2-Sided|95.0|2.9|8.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728977|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|1.42|||<|0.1608|2-Sided|95.0|0.6|3.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728978|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|7.39|||<|0.0001|2-Sided|95.0|3.8|14.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72|
1728979|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|5.92|||<|0.0001|2-Sided|95.0|3.2|10.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1728980|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|0.91|||<|0.8842|2-Sided|95.0|0.4|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1728981|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|6.29|||<|0.0001|2-Sided|95.0|3.3|12.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1728982|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|5.58|||<|0.0001|2-Sided|95.0|3.0|10.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1728983|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|0.81|||<|0.5708|2-Sided|95.0|0.4|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1728984|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|4.4|||<|0.0001|2-Sided|95.0|2.4|8.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56|
1728985|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|5.33|||<|0.0001|2-Sided|95.0|2.8|10.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1728986|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|0.88|||<|0.8973|2-Sided|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1728987|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|5.61|||<|0.0001|2-Sided|95.0|3.0|10.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48|
1728988|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|5.14|||<|0.0001|2-Sided|95.0|2.5|10.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1728989|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|0.81|||<|0.4337|2-Sided|95.0|0.3|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1728990|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|4.1|||<|0.0001|2-Sided|95.0|2.1|8.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40|
1728991|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|2.27|||<|0.213|2-Sided|95.0|0.5|10.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728992|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|1.17|||<|0.8303|2-Sided|95.0|0.2|7.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728993|NCT00565409|3184911|Superiority or Other||Odds Ratio (OR)|2.29|||<|0.1718|2-Sided|95.0|0.5|10.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1728994|NCT00565409|3184912|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 36|
1728995|NCT00565409|3184912|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 28|
1728996|NCT00565409|3184912|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 20|
1728997|NCT00565409|3184912|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 12|
1728998|NCT00565409|3184912|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 8|
1728999|NCT00565409|3184912|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Week 4|
1729000|NCT00565409|3184913|Superiority or Other||Odds Ratio (OR)|2.34||||0.0004|2-Sided|95.0|1.4|4.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1729001|NCT00565409|3184913|Superiority or Other||Odds Ratio (OR)|1.9||||0.0272|2-Sided|95.0|1.0|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1729002|NCT00565409|3184913|Superiority or Other||Odds Ratio (OR)|3.92|||<|0.0001|2-Sided|95.0|2.1|7.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88|
1729003|NCT00565409|3184913|Superiority or Other||Odds Ratio (OR)|4.23|||<|0.0001|2-Sided|95.0|2.4|7.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1729004|NCT00565409|3184913|Superiority or Other||Odds Ratio (OR)|1.24|||<|0.4032|2-Sided|95.0|0.6|2.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1729005|NCT00565409|3184913|Superiority or Other||Odds Ratio (OR)|4.18|||<|0.0001|2-Sided|95.0|2.3|7.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64|
1729006|NCT00565409|3184913|Superiority or Other||Odds Ratio (OR)|0.67|||<|0.19|2-Sided|95.0|0.3|1.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1729007|NCT00565409|3184913|Superiority or Other||Odds Ratio (OR)|1.67|||<|0.1105|2-Sided|95.0|0.8|3.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1729008|NCT00565409|3184913|Superiority or Other||Odds Ratio (OR)|1.1|||<|0.8974|2-Sided|95.0|0.5|2.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36|
1729009|NCT00565409|3184914|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel||||
1729010|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-12.26|||<|0.0001|2-Sided|95.0|-16.1|-8.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729011|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-2.44|||<|0.2077|2-Sided|95.0|-6.2|1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729012|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-14.7|||<|0.0001|2-Sided|95.0|-18.5|-10.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729013|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-12.31|||<|0.0001|2-Sided|95.0|-16.1|-8.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729014|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-2.56|||<|0.1808|2-Sided|95.0|-6.3|1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729015|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-14.87|||<|0.0001|2-Sided|95.0|-18.6|-11.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729016|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-12.85|||<|0.0001|2-Sided|95.0|-16.6|-9.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729017|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-2.8|||<|0.1477|2-Sided|95.0|-6.6|1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729018|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-15.64|||<|0.0001|2-Sided|95.0|-19.4|-11.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729019|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-11.94|||<|0.0001|2-Sided|95.0|-15.6|-8.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729020|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-1.94|||<|0.2972|2-Sided|95.0|-5.6|1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729021|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-13.88|||<|0.0001|2-Sided|95.0|-17.6|-10.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729022|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-11.5|||<|0.0001|2-Sided|95.0|-15.1|-7.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729023|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-1.02|||<|0.5732|2-Sided|95.0|-4.6|2.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization|ANCOVA|||Week 56|
1729024|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-12.53|||<|0.0001|2-Sided|95.0|-16.1|-8.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729025|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-13.11|||<|0.0001|2-Sided|95.0|-16.7|-9.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729026|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.783|2-Sided|95.0|-4.1|3.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729027|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-13.61|||<|0.0001|2-Sided|95.0|-17.2|-10.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729028|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-8.14|||<|0.0001|2-Sided|95.0|-11.3|-4.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729029|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-0.4|||<|0.8033|2-Sided|95.0|-3.6|2.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729030|NCT00565409|3184915|Superiority or Other||Mean Difference (Final Values)|-8.55|||<|0.0001|2-Sided|95.0|-11.8|-5.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729031|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-10.83|||<|0.0001|2-Sided|95.0|-14.5|-7.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729032|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-2.33|||<|0.213|2-Sided|95.0|-6.0|1.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729033|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-13.16|||<|0.0001|2-Sided|95.0|-16.9|-9.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729034|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-12.68|||<|0.0001|2-Sided|95.0|-16.2|-9.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729035|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-1.88|||<|0.2948|2-Sided|95.0|-5.4|1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729036|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-14.56|||<|0.0001|2-Sided|95.0|-18.1|-11.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1734614|NCT00509392|3193642|Superiority or Other|||||||0.005|||||||Fisher Exact||||
1729037|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-11.67|||<|0.0001|2-Sided|95.0|-15.4|-8.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729038|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-3.12|||<|0.096|2-Sided|95.0|-6.8|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729039|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-14.79|||<|0.0001|2-Sided|95.0|-18.5|-11.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729040|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-11.51|||<|0.0001|2-Sided|95.0|-14.9|-8.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729041|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-1.32|||<|0.4437|2-Sided|95.0|-4.7|2.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729042|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-12.83|||<|0.0001|2-Sided|95.0|-16.2|-9.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729043|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-10.73|||<|0.0001|2-Sided|95.0|-14.2|-7.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729044|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-1.36|||<|0.4404|2-Sided|95.0|-4.8|2.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729045|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-12.09|||<|0.0001|2-Sided|95.0|-15.6|-8.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729046|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-11.39|||<|0.0001|2-Sided|95.0|-14.7|-8.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729047|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-0.69|||<|0.6802|2-Sided|95.0|-4.0|2.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729048|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-12.09|||<|0.0001|2-Sided|95.0|-15.4|-8.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729049|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-6.23|||<|0.0001|2-Sided|95.0|-9.3|-3.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729050|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-2.55|||<|0.1033|2-Sided|95.0|-5.6|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729051|NCT00565409|3184918|Superiority or Other||Mean Difference (Final Values)|-8.79|||<|0.0001|2-Sided|95.0|-11.9|-5.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729052|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-83.91||||0.0003|2-Sided|95.0|-129.2|-38.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729053|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|12.3||||0.5917|2-Sided|95.0|-32.7|57.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729054|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-71.6||||0.002|2-Sided|95.0|-116.9|-26.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729055|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-101.8|||<|0.0001|2-Sided|95.0|-144.0|-59.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729056|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-13.69|||<|0.5219|2-Sided|95.0|-55.6|28.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729057|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-115.48|||<|0.0001|2-Sided|95.0|-157.7|-73.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729058|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-98.53|||<|0.0001|2-Sided|95.0|-146.7|-50.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1734615|NCT00509392|3193643|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1729059|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-10.2|||<|0.6764|2-Sided|95.0|-58.2|37.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729060|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-108.73|||<|0.0001|2-Sided|95.0|-157.0|-60.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729061|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-82.52|||<|0.0003|2-Sided|95.0|-127.2|-37.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729062|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-1.85|||<|0.935|2-Sided|95.0|-46.3|42.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729063|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-84.36|||<|0.0002|2-Sided|95.0|-129.1|-39.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729064|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-63.05|||<|0.0018|2-Sided|95.0|-102.5|-23.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729065|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-26.14|||<|0.191|2-Sided|95.0|-65.4|13.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729066|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-89.19|||<|0.0001|2-Sided|95.0|-128.7|-49.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729067|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-36.87|||<|0.0721|2-Sided|95.0|-77.1|3.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729068|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-43.18|||<|0.0344|2-Sided|95.0|-83.2|-3.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729069|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-80.05|||<|0.0001|2-Sided|95.0|-120.3|-39.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729070|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-31.1|||<|0.0826|2-Sided|95.0|-66.2|4.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729071|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-10.57|||<|0.5544|2-Sided|95.0|-45.6|24.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729072|NCT00565409|3184921|Superiority or Other||Mean Difference (Final Values)|-41.67|||<|0.0214|2-Sided|95.0|-77.1|-6.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729073|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-1.24|||<|0.0001|2-Sided|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729074|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.1158|2-Sided|95.0|-0.7|0.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729075|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-1.54|||<|0.0001|2-Sided|95.0|-1.9|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729076|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-1.13|||<|0.0001|2-Sided|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729077|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-0.42|||<|0.0256|2-Sided|95.0|-0.8|-0.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729078|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-1.54|||<|0.0001|2-Sided|95.0|-1.9|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729079|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-1.26|||<|0.0001|2-Sided|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729080|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-0.34|||<|0.0816|2-Sided|95.0|-0.7|0.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729874|NCT00556322|3186249|Superiority or Other||Hazard Ratio (HR)|0.96||||0.7299|2-Sided|95.0|0.78|1.19|||Log Rank||||
1729081|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-1.6|||<|0.0001|2-Sided|95.0|-2.0|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729082|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-1.14|||<|0.0001|2-Sided|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729083|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-0.16|||<|0.3793|2-Sided|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729084|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-1.3|||<|0.0001|2-Sided|95.0|-1.7|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729085|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-1.16|||<|0.0001|2-Sided|95.0|-1.5|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729086|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-0.13|||<|0.4645|2-Sided|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729087|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-1.29|||<|0.0001|2-Sided|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729088|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-1.23|||<|0.0001|2-Sided|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729089|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-0.18|||<|0.3129|2-Sided|95.0|-0.5|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729090|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-1.4|||<|0.0001|2-Sided|95.0|-1.7|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729091|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-0.82|||<|0.0001|2-Sided|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729092|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-0.05|||<|0.7427|2-Sided|95.0|-0.4|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729093|NCT00565409|3184924|Superiority or Other||Mean Difference (Final Values)|-0.88|||<|0.0001|2-Sided|95.0|-1.2|-0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729094|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-1.32|||<|0.0001|2-Sided|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729095|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-0.12|||<|0.4753|2-Sided|95.0|-0.4|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729096|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-1.43|||<|0.0001|2-Sided|95.0|-1.8|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729097|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-1.27|||<|0.0001|2-Sided|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729098|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-0.07|||<|0.6552|2-Sided|95.0|-0.4|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729099|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-1.34|||<|0.0001|2-Sided|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729100|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-1.34|||<|0.0001|2-Sided|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729101|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|0.08|||<|0.61|2-Sided|95.0|-0.2|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729102|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-1.26|||<|0.0001|2-Sided|95.0|-1.6|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1730001|NCT00554515|3186518|Superiority|||||||0.89|||||||Fisher Exact|||Objective response rates were compared between clear cell histology subgroups|
1729103|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-1.26|||<|0.0001|2-Sided|95.0|-1.6|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729104|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|0.16|||<|0.3118|2-Sided|95.0|-0.1|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729105|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-1.1|||<|0.0001|2-Sided|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729106|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-1.15|||<|0.0001|2-Sided|95.0|-1.4|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729107|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|0.03|||<|0.8404|2-Sided|95.0|-0.3|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729108|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-1.12|||<|0.0001|2-Sided|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729109|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-1.22|||<|0.0001|2-Sided|95.0|-1.5|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729110|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|0.11|||<|0.4605|2-Sided|95.0|-0.2|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729111|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-1.11|||<|0.0001|2-Sided|95.0|-1.4|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729112|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-0.74|||<|0.0001|2-Sided|95.0|-1.0|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729113|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|0.01|||<|0.9636|2-Sided|95.0|-0.2|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729114|NCT00565409|3184927|Superiority or Other||Mean Difference (Final Values)|-0.73|||<|0.0001|2-Sided|95.0|-1.0|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729115|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-2.35|||<|0.0001|2-Sided|95.0|-3.0|-1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729116|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-0.06|||<|0.8688|2-Sided|95.0|-0.7|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729117|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-2.41|||<|0.0001|2-Sided|95.0|-3.1|-1.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729118|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-2.14|||<|0.0001|2-Sided|95.0|-2.8|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729119|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-0.15|||<|0.6558|2-Sided|95.0|-0.8|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729120|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-2.28|||<|0.0001|2-Sided|95.0|-2.9|-1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729121|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-2.23|||<|0.0001|2-Sided|95.0|-2.9|-1.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729122|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-0.15|||<|0.6323|2-Sided|95.0|-0.8|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729123|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-2.38|||<|0.0001|2-Sided|95.0|-3.0|-1.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729124|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-2.03|||<|0.0001|2-Sided|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729808|NCT00557245|3186054|Superiority or Other||Slope Difference over time|0.07||||0.08|||||||Mixed Models Analysis|Linear mixed-effects model|Placebo arm is the reference group.||
1729125|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|0.06|||<|0.8587|2-Sided|95.0|-0.6|0.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729126|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-1.98|||<|0.0001|2-Sided|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729127|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-2.0|||<|0.0001|2-Sided|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729128|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-0.06|||<|0.8437|2-Sided|95.0|-0.6|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729129|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-2.06|||<|0.0001|2-Sided|95.0|-2.6|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729130|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-2.06|||<|0.0001|2-Sided|95.0|-2.6|-1.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729131|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|0.04|||<|0.9048|2-Sided|95.0|-0.5|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANOVA|||Week 48|
1729132|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-2.02|||<|0.0001|2-Sided|95.0|-2.6|-1.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729133|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-0.98|||<|0.0001|2-Sided|95.0|-1.4|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729134|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|0.12|||<|0.6088|2-Sided|95.0|-0.3|0.6||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729135|NCT00565409|3184930|Superiority or Other||Mean Difference (Final Values)|-0.86|||<|0.0003|2-Sided|95.0|-1.3|-0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729136|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-1.44|||<|0.0001|2-Sided|95.0|-1.9|-0.9||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729137|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-0.31|||<|0.2182|2-Sided|95.0|-0.8|0.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729138|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-1.75|||<|0.0001|2-Sided|95.0|-2.3|-1.2||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 88|
1729139|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-1.5|||<|0.0001|2-Sided|95.0|-2.0|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729140|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-0.07|||<|0.7695|2-Sided|95.0|-0.6|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729141|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-1.58|||<|0.0001|2-Sided|95.0|-2.1|-1.1||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 80|
1729142|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-1.42|||<|0.0001|2-Sided|95.0|-1.9|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729143|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-0.02|||<|0.9279|2-Sided|95.0|-0.5|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729144|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-1.44|||<|0.0001|2-Sided|95.0|-1.9|-1.0||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 72|
1729145|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-1.3|||<|0.0001|2-Sided|95.0|-1.8|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729146|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|0.02|||<|0.9229|2-Sided|95.0|-0.4|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729809|NCT00557245|3186054|Superiority or Other|||||||0.42|||||||Mixed Models Analysis|linear mixed-effects model|||
1729147|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-1.28|||<|0.0001|2-Sided|95.0|-1.8|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 64|
1729148|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-1.24|||<|0.0001|2-Sided|95.0|-1.7|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729149|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|0.03|||<|0.9074|2-Sided|95.0|-0.4|0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729150|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-1.21|||<|0.0001|2-Sided|95.0|-1.7|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 56|
1729151|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-1.18|||<|0.0001|2-Sided|95.0|-1.6|-0.8||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729152|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|0.04|||<|0.8534|2-Sided|95.0|-0.4|0.4||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729153|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-1.14|||<|0.0001|2-Sided|95.0|-1.5|-0.7||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 48|
1729154|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-0.78|||<|0.0001|2-Sided|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729155|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-0.04|||<|0.8015|2-Sided|95.0|-0.3|0.3||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729156|NCT00565409|3184933|Superiority or Other||Mean Difference (Final Values)|-0.81|||<|0.0001|2-Sided|95.0|-1.1|-0.5||ANCOVA model: Change = Week 36 score + treatment + geographic region + DAS28 Strata. DAS28 Strata is defined as DAS28 low disease (≤3.2) or remission (<2.6) at randomization.|ANCOVA|||Week 40|
1729157|NCT00565409|3184937|Superiority or Other||||||<|0.0001||||||Week 88 censored data was censored at 372 days.|Log Rank||||
1729158|NCT00565409|3184937|Superiority or Other||||||<|0.9841||||||Week 88 censored data was censored at 372 days.|Log Rank||||
1729159|NCT00565409|3184937|Superiority or Other||||||<|0.0001||||||Week 88 censored data was censored at 372 days.|Log Rank||||
1729160|NCT00565409|3184938|Superiority or Other|||||||0.8622||||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.|
1729161|NCT00565409|3184938|Superiority or Other||||||<|0.0001||||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.|
1729162|NCT00565409|3184938|Superiority or Other||||||<|0.0001||||||Week 88 censored data was censored at 372 days.|Log Rank|||Imputation of failure defined as participants who did not reach the endpoint and discontinued due to lack of efficacy, with reason of unsatisfactory response-efficacy, adverse event, other or protocol violation were set to an event at time of discontinuation.|
1729163|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-0.94|||<|0.0001|2-Sided|95.0|-1.2|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88|
1729164|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-0.1|||<|0.3562|2-Sided|95.0|-0.3|0.1|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88|
1729165|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-1.04|||<|0.0001|2-Sided|95.0|-1.3|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 88|
1729166|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-1.02|||<|0.0001|2-Sided|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80|
1729167|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|0.0|||<|0.981|2-Sided|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80|
1729168|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-1.02|||<|0.0001|2-Sided|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 80|
1729169|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-1.02|||<|0.0001|2-Sided|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72|
1729170|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-0.03|||<|0.7847|2-Sided|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72|
1729171|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-1.05|||<|0.0001|2-Sided|95.0|-1.3|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 72|
1729172|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-0.93|||<|0.0001|2-Sided|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64|
1729173|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|0.07|||<|0.4868|2-Sided|95.0|-0.1|0.3|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 64|
1729175|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-0.98|||<|0.0001|2-Sided|95.0|-1.2|-0.8|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56|
1729176|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|0.06|||<|0.5136|2-Sided|95.0|-0.1|0.3|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56|
1729177|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-0.92|||<|0.0001|2-Sided|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 56|
1729178|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-0.89|||<|0.0001|2-Sided|95.0|-1.1|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48|
1729179|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|0.05|||<|0.6173|2-Sided|95.0|-0.1|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48|
1729180|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-0.84|||<|0.0001|2-Sided|95.0|-1.0|-0.7|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 48|
1729181|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-0.53|||<|0.0001|2-Sided|95.0|-0.7|-0.4|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40|
1729182|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-0.01|||<|0.9344|2-Sided|95.0|-0.2|0.2|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40|
1729183|NCT00565409|3184939|Superiority or Other||Mean Difference (Final Values)|-0.54|||<|0.0001|2-Sided|95.0|-0.7|-0.4|||ANCOVA|ANCOVA model: Change = Week 36 score + treatment + geographic region.||Week 40|
1729184|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|3.85|||<|0.0001|2-Sided|95.0|2.5|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission|
1729185|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.2|||<|0.1109|2-Sided|95.0|0.8|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission|
1729186|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|4.41|||<|0.0001|2-Sided|95.0|2.8|7.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Remission|
1729187|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|4.11|||<|0.0001|2-Sided|95.0|2.6|6.4|||Cochran-Mantel-Haenszel|||Week 80 Remission|
1729188|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.13|||<|0.5499|2-Sided|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Remission|
1729189|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|4.96|||<|0.0001|2-Sided|95.0|3.1|7.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Remission|
1729190|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|4.79|||<|0.0001|2-Sided|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission|
1729191|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.15|||<|0.6464|2-Sided|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission|
1729192|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|5.36|||<|0.0001|2-Sided|95.0|3.3|8.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Remission|
1729193|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|3.84|||<|0.0001|2-Sided|95.0|2.5|6.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission|
1729194|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.14|||<|0.5229|2-Sided|95.0|0.7|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission|
1729195|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|4.19|||<|0.0001|2-Sided|95.0|2.7|6.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Remission|
1729196|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|5.04|||<|0.0001|2-Sided|95.0|3.2|8.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission|
1729197|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|0.86|||<|0.4574|2-Sided|95.0|0.5|1.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission|
1729198|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|4.09|||<|0.0001|2-Sided|95.0|2.6|6.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Remission|
1729199|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|3.12|||<|0.0001|2-Sided|95.0|2.0|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission|
1729200|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.11|||<|0.5351|2-Sided|95.0|0.7|1.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission|
1729201|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|3.33|||<|0.0001|2-Sided|95.0|2.1|5.2||p-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Remission|
1729810|NCT00557245|3186055|Superiority or Other|||||||0.86|||||||Regression, Logistic|generalized estimating equations with logistic link to account for multiple pregnancies and multiple births|||
1729202|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|2.31|||<|0.0001|2-Sided|95.0|1.5|3.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission|
1729203|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.26|||<|0.2091|2-Sided|95.0|0.8|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission|
1729204|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|2.94|||<|0.0001|2-Sided|95.0|1.8|4.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Remission|
1729205|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|0.83|||<|0.7779|2-Sided|95.0|0.4|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission|
1729206|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.44|||<|0.2886|2-Sided|95.0|0.6|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission|
1729207|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.3|||<|0.4626|2-Sided|95.0|0.5|3.3||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Remission|
1729208|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|4.68|||<|0.0001|2-Sided|95.0|3.0|7.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity|
1729209|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.03|||<|0.6064|2-Sided|95.0|0.6|1.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity|
1729210|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|4.68|||<|0.0001|2-Sided|95.0|2.8|7.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 88 Low Disease Activity|
1729211|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|5.12|||<|0.0001|2-Sided|95.0|3.2|8.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity|
1729212|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.2|||<|0.4326|2-Sided|95.0|0.7|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity|
1729213|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|5.74|||<|0.0001|2-Sided|95.0|3.4|9.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 80 Low Disease Activity|
1729214|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|5.46|||<|0.0001|2-Sided|95.0|3.4|8.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity|
1729215|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.08|||<|0.6692|2-Sided|95.0|0.6|1.9||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity|
1729216|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|6.25|||<|0.0001|2-Sided|95.0|3.7|10.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 72 Low Disease Activity|
1729217|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|4.78|||<|0.0001|2-Sided|95.0|3.0|7.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity|
1729218|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|0.88|||<|0.9399|2-Sided|95.0|0.5|1.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity|
1729219|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|4.62|||<|0.0001|2-Sided|95.0|2.8|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 64 Low Disease Activity|
1729220|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|5.4|||<|0.0001|2-Sided|95.0|3.4|8.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity|
1729221|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.14|||<|0.6716|2-Sided|95.0|0.6|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity|
1729222|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|6.52|||<|0.0001|2-Sided|95.0|3.9|11.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 56 Low Disease Activity|
1729223|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|3.76|||<|0.0001|2-Sided|95.0|2.3|6.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity|
1729224|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.18|||<|0.5871|2-Sided|95.0|0.7|2.1||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity|
1729225|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|4.55|||<|0.0001|2-Sided|95.0|2.7|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 48 Low Disease Activity|
1729226|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|2.51|||<|0.0001|2-Sided|95.0|1.5|4.2||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity|
1729227|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|1.43|||<|0.3027|2-Sided|95.0|0.8|2.7||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity|
1729228|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|3.63|||<|0.0001|2-Sided|95.0|2.1|6.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 40 Low Disease Activity|
1729229|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|3.97|||<|0.1278|2-Sided|95.0|0.4|42.5||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity|
1729230|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|0.96|||<|0.8491|2-Sided|95.0|0.2|4.8||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity|
1729231|NCT00565409|3184941|Superiority or Other||Odds Ratio (OR)|3.11|||<|0.0853|2-Sided|95.0|0.5|21.4||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|||Week 36 Low Disease Activity|
1729232|NCT00565409|3184943|Superiority or Other||Odds Ratio (OR)|4.81|||<|0.0001|2-Sided|95.0|3.0|7.6||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|LOE imputation defined as LOE drop-outs were treated as non-responders and all other participants had LOCF applied as primary analysis.|||
1729233|NCT00565409|3184943|Superiority or Other||Odds Ratio (OR)|1.15|||<|0.3805|2-Sided|95.0|0.7|2.0||P-value from CMH test of general association, testing treatment effect on response. P-value and OR stratified by geographic region.|Cochran-Mantel-Haenszel|LOE imputation defined as LOE drop-outs were treated as non-responders and all other participants had LOCF applied as primary analysis.|||
1729234|NCT00565409|3184943|Superiority or Other||Odds Ratio (OR)|5.36|||<|0.0001|2-Sided|95.0|3.2|9.0||P-value from Cochran-Mantel-Haenszel(CMH) test of general association, testing treatment effect on response. P-value and Odds Ratio (OR) stratified by geographic region.|Cochran-Mantel-Haenszel|Loss of efficacy (LOE) imputation defined as LOE drop-outs were treated as non-responders/all other participants had LOCF applied as primary analysis.||Sample size estimated based on moderate/severe rheumatoid arthritis(RA) trial. Study design included only moderate RA participants, thus a low disease activity estimate of 85% (ETN+MTX) vs 70% (MTX only) assumed, required 175 randomized participants in 3 treatments for a 90% power and Type I error of 0.05 to reject the null hypothesis of no ETN+MTX vs MTX only differences. More participants qualified for Period 2 than expected, Period 2 sample size roughly 15% larger than protocol-specified.|
1729235|NCT00565084|3184973|Superiority or Other||Difference in LS Means|0.06||||0.743||90.0|-0.23|0.35|||ANOVA|||Primary efficacy endpoint was assessed by an ANOVA model with terms for treatment, period, sequence, and patients within sequence. Efficacy advantage over placebo was assessed via the treatment difference in the least-squares (LS) means (ibuprofen vs. average of the 2 placebo treatments) from the ANOVA model and the 90% confidence interval (CI; one-sided alpha=0.05) of the LS mean difference will be assessed.|
1729236|NCT00564278|3185042|Superiority or Other||Mixed Model Beta for MADT vs SADT|9.14|||||2-Sided|95.0|2.71|15.57|||||A Generalized Linear Mixed Model was used with random intercept for clinician to model the effect of MPT vs. SADT on the mean proportion of fully adherent days over the study period. We used an exchangeable covariance structure.||
1729237|NCT00564278|3185043|Superiority or Other||Mixed Model Beta for MADT vs SADT|-0.04|||||2-Sided|95.0|-0.74|0.66|||||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline patient satisfaction and time to assess the effect of MADT vs. SADT on mean patient satisfaction over follow-up.||
1729238|NCT00564278|3185044|Superiority or Other||Mixed Model Beta for MADT vs SADT|0.02|||||2-Sided|95.0|-3.61|3.64|||||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline QOL score and time to assess the effect of MADT vs. SADT on mean percent of quality of life over follow-up.||
1729239|NCT00564278|3185045|Superiority or Other||Family-Mixed Model Beta for MADT vs SADT|0.55|||||2-Sided|95.0|-0.08|1.18|||||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline family-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the family domain over follow-up.||
1729240|NCT00564278|3185045|Superiority or Other||Social-Mixed Model Beta for MADT vs SADT|0.22|||||2-Sided|95.0|-0.49|0.92|||||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline social-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the social domain over follow-up.||
1729241|NCT00564278|3185045|Superiority or Other||Work - Mixed Model Beta for MADT vs SADT|0.22|||||2-Sided|95.0|-0.5|0.95|||||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline work-related disability score and time to assess the effect of MADT vs. SADT on mean disability score in the work domain over follow-up.||
1729242|NCT00564278|3185046|Superiority or Other||Mixed Model Beta for MADT vs SADT|-0.28|||||2-Sided|95.0|-1.57|1.01|||||A Generalized Linear Mixed Model was used with random intercept for clinician adjusted for baseline depressive symptoms and time to assess the effect of MADT vs. SADT on mean depressive symptoms over follow-up.||
1729243|NCT00564278|3185047|Superiority or Other||GEE model Beta|17.46||||0.26|2-Sided|95.0|-16.61|51.53||All analyses presented are at 9 months.|t-test, 2 sided|t(193) = -1.14, p=.26||"We also conducted an analysis using a Generalized Estimating Equations model adjusting for a number of covariates.~We will conduct a three-part regression analysis assessing early/middle/late effects of MPT on retention. We will also conduct moderator analyses, as described in the original study grant, to determine whether there are specific patient groups for whom a significant difference in days in treatment is found."|
1729483|NCT00561821|3185281|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729244|NCT00564070|3185049|Superiority or Other||Mean Difference (Final Values)|0.63|Standard Error of the Mean|0.29||0.03|2-Sided|95.0|0.6|1.2|||Mixed Models Analysis|||We hypothesized that glucose control (HbA1C) would remain superior in the CBT-AD arm compared to the ETAU arm over follow up.|
1729245|NCT00564070|3185050|Superiority or Other||Mean Difference (Final Values)|0.48|Standard Error of the Mean|0.29||0.1|2-Sided|95.0|-0.1|1.1|||Mixed Models Analysis|||We hypothesized that depression scores would remain lower in the CBT-AD arm compared to the ETAU arm|
1729246|NCT00564070|3185051|Superiority or Other||Mean Difference (Final Values)|3.0|Standard Error of the Mean|2.1||0.16|2-Sided|95.0|-1.2|7.2|||Mixed Models Analysis|||We hypothesized that the lower depression scores would remain in the CBT arm compared to ETAU over follow up.|
1729247|NCT00564070|3185052|Superiority or Other||Mean Difference (Final Values)|16.3|Standard Error of the Mean|5.0|=|0|2-Sided|95.0|6.5|26.1|||Mixed Models Analysis|||We hypothesized that the CBT-AD condition would maintain higher medication adherence over follow up compared to ETAU|
1729248|NCT00564070|3185053|Superiority or Other||Median Difference (Final Values)|22.3|Standard Error of the Mean|7.0|=|0|2-Sided|95.0|8.6|36.1|||Mixed Models Analysis|||We hypothesized that differences in glucose monitoring adherence would continue to be superior in the CBT-AD condition compared to ETAU|
1729249|NCT00564070|3185054|Superiority or Other||Mean Difference (Final Values)|0.74|||=|0|2-Sided|95.0|0.16|1.32|||ANCOVA|using GLM|The Mean Difference was calculated as CGI unit scale for the Enhanced Treatment as Usual Arm minus the CGI unit scale for the CBT-AD Arm.||
1729250|NCT00564070|3185055|Superiority or Other||Mean Difference (Final Values)|6.22|||=|0|2-Sided|95.0|2.33|10.56|||Mixed Models Analysis|General linear model, controlling for baseline values.|The Mean Difference was calculated as MADRS unit scale for the CBT-AD Arm minus the MADRS unit scale for the Enhanced Treatment as Usual Arm.|Analyses are reported for the acute outcomes of depression as assessed on the MADRS at acute outcome.|
1729251|NCT00564070|3185056|Superiority or Other||Mean Difference (Final Values)|20.7|||<|0.0001|2-Sided|95.0|10.22|31.14|||Mixed Models Analysis||The Mean Difference was calculated as percent pill adherence via MEMs for the CBT-AD Arm minus the percent pill adherence for the Enhanced Treatment as Usual Arm.|Analyses are reported for the acute outcomes of MEMs monitoring (4 month). Higher percentages represent better adherence.|
1729252|NCT00564070|3185057|Superiority or Other||Mean Difference (Final Values)|0.72|||=|0|2-Sided|95.0|0.29|1.15|||ANCOVA|General linear model; Controlling for baseline values|The Mean Difference was calculated as percent of HbA1c for the Enhanced Treatment as Usual Arm minus percent of HbA1c for the CBT-AD Arm.|Multiple imputation was used to handle missing data; results are reported for HbA1c at the acute outcome (i.e., 4 months)|
1729253|NCT00564070|3185058|Superiority or Other||Mean Difference (Final Values)|30.2|||<|0.0001|2-Sided|95.0|17.37|42.9|||Mixed Models Analysis|General linear model, controlling for baseline values|The Mean Difference was calculated as percent adherence to glucose monitoring for the CBT-AD Arm minus the adherence to glucose monitoring for the Enhanced Treatment as Usual Arm.|Multiple imputation was used to handle missing data; analyses are reported for the acute outcomes of glucose monitoring (i.e., 4 month)|
1729254|NCT00563797|3185061|Superiority or Other|||||||0.019|||||||Mixed Models Analysis||||
1729255|NCT00563797|3185062|Superiority or Other|||||||0.025|||||||Mixed Models Analysis||||
1729256|NCT00563797|3185063|Superiority or Other|||||||0.0001||||||F=36.32|Mixed Models Analysis|||Comparison of baseline and post-treatment|
1729257|NCT00563797|3185064|Superiority or Other|||||||0.014||||||F=7.73|Mixed Models Analysis|||Comparison is between baseline and during treatment.|
1729258|NCT00563706|3185075|Superiority or Other||LS Mean Difference|-1.44||||0.765|2-Sided|95.0|-10.92|8.04|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.|
1729259|NCT00563706|3185075|Superiority or Other||LS Mean Difference|-9.73||||0.075|2-Sided|95.0|-20.46|1.0|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.|
1729260|NCT00563706|3185075|Superiority or Other||LS Mean Difference|-3.18||||0.647|2-Sided|95.0|-16.87|10.5|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.|
1729261|NCT00563706|3185075|Superiority or Other||LS Mean Difference|-10.9||||0.07|2-Sided|95.0|-22.71|0.92|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.|
1729262|NCT00563706|3185075|Superiority or Other||LS Mean Difference|-3.61||||0.567|2-Sided|95.0|-16.02|8.8|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.|
1729263|NCT00563706|3185075|Superiority or Other||LS Mean Difference|-11.61||||0.067|2-Sided|95.0|-24.03|0.81|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.|
1729264|NCT00563706|3185075|Superiority or Other||LS Mean Difference|-6.77||||0.457|2-Sided|95.0|-24.7|11.16|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.|
1729265|NCT00563706|3185075|Superiority or Other||Least Squares (LS) Mean Difference|-12.3||||0.043|2-Sided|95.0|-24.24|-0.37|||Mixed Models Analysis|||Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.|
1729266|NCT00563381|3185081|Superiority or Other||difference in peak expiratory flow rates|-0.59||||0.552||95.0|-2.55|1.36|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729267|NCT00563381|3185082|Superiority or Other||difference in peak expiratory flow rates|-1.1||||0.2682||95.0|-3.05|0.85|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729268|NCT00563381|3185083|Superiority or Other||difference in peak expiratory flow rates|-1.23||||0.2174||95.0|-3.18|0.72|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729269|NCT00563381|3185084|Superiority or Other||difference in peak expiratory flow rates|-0.67||||0.5017||95.0|-2.62|1.28|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729270|NCT00563381|3185085|Superiority or Other||difference in peak expiratory flow rates|-0.99||||0.3172||95.0|-2.94|0.95|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729271|NCT00563381|3185086|Superiority or Other||difference in peak expiratory flow rates|-1.3||||0.1904||95.0|-3.25|0.65|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729272|NCT00563381|3185087|Superiority or Other||difference in peak expiratory flow rates|-0.97||||0.3297||95.0|-2.92|0.98|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729273|NCT00563381|3185088|Superiority or Other||difference in peak expiratory flow rates|-0.85||||0.3931||95.0|-2.8|1.1|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729274|NCT00563381|3185089|Superiority or Other||difference in peak expiratory flow rates|-0.48||||0.6277||95.0|-2.42|1.46|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729275|NCT00563381|3185090|Superiority or Other||difference in peak expiratory flow rates|-0.78||||0.4299||95.0|-2.72|1.16|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729276|NCT00563381|3185091|Superiority or Other||difference in peak expiratory flow rates|-1.01||||0.3068||95.0|-2.95|0.93|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729277|NCT00563381|3185092|Superiority or Other||difference in peak expiratory flow rates|-1.1||||0.2641||95.0|-3.04|0.83|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729278|NCT00563381|3185093|Superiority or Other||difference in peak expiratory flow rates|-1.88||||0.0573||95.0|-3.82|0.06|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729279|NCT00563381|3185094|Superiority or Other||difference in peak expiratory flow rates|-2.07||||0.0362||95.0|-4.0|-0.13|||Mixed Effects Repeated Measures Model|MMRM (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729280|NCT00563381|3185095|Superiority or Other||difference in peak expiratory flow rates|-2.06||||0.0369||95.0|-3.99|-0.12|||Mixed Effects Repeated Measures Model|Mixed effects repeated measures model (MRMM)(fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week).||Tiotropium versus Salmeterol|
1729281|NCT00563381|3185096|Superiority or Other||difference in peak expiratory flow rates|-1.6||||0.1035||95.0|-3.53|0.33|||Mixed Effects Repeated Measures Model|Mixed effects repeated measures model (MMRM) (fixed terms: treatment, centre, week, treatment*week; covariates: baseline PEFR, baseline PEFR*week)||Tiotropium versus Salmeterol|
1729282|NCT00563381|3185097|Superiority or Other||Rate ratio (ratio of incidence rates)|0.8|Standard Error of the Mean|0.04|<|0.0001||95.0|0.73|0.88|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol|
1729283|NCT00563381|3185098|Superiority or Other||Rate ratio (ratio of incidence rates)|0.9|Standard Error of the Mean|0.03||0.0036||95.0|0.84|0.97|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol|
1729284|NCT00563381|3185099|Superiority or Other||Rate ratio (ratio of incidence rates)|0.82|Standard Error of the Mean|0.04|<|0.0001||95.0|0.76|0.9|||Poisson regression|Poisson regression correcting for overdispersion and adjusted for treatment exposure||Tiotropium versus Salmeterol|
1729285|NCT00563381|3185100|Superiority or Other||Hazard Ratio (HR)|0.76|||<|0.0001||95.0|0.68|0.86|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol|
1729286|NCT00563381|3185101|Superiority or Other||Hazard Ratio (HR)|0.85|||<|0.0001||95.0|0.78|0.92|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol|
1729287|NCT00563381|3185102|Superiority or Other||Hazard Ratio (HR)|0.77|||<|0.0001||95.0|0.69|0.85|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol|
1729288|NCT00563381|3185103|Superiority or Other||Hazard Ratio (HR)|0.84|||<|0.0001||95.0|0.78|0.91|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol|
1729289|NCT00563381|3185104|Superiority or Other||Risk Ratio (RR)|0.9||||0.0406||95.0|0.82|1.0|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol|
1729290|NCT00563381|3185105|Superiority or Other||Hazard Ratio (HR)|0.88||||0.0242||95.0|0.78|0.98|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol|
1729291|NCT00563381|3185106|Superiority or Other||Risk Ratio (RR)|0.77||||0.0005||95.0|0.66|0.89|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol|
1729292|NCT00563381|3185107|Superiority or Other||Hazard Ratio (HR)|0.72|||<|0.0001||95.0|0.61|0.85|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol|
1729484|NCT00561821|3185281|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729293|NCT00563381|3185108|Superiority or Other||Rate ratio (ratio of incidence rates)|0.89|Standard Error of the Mean|0.03||0.0017||95.0|0.83|0.96|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium versus Salmeterol|
1729294|NCT00563381|3185109|Superiority or Other||Risk Ratio (RR)|0.9||||0.0002||95.0|0.85|0.95|||Cochran-Mantel-Haenszel|||Tiotropium versus Salmeterol|
1729295|NCT00563381|3185110|Superiority or Other||Rate ratio (ratio of incidence rates)|0.73|Standard Error of the Mean|0.04|<|0.0001||95.0|0.66|0.82|||Poisson regression|Poisson regression correcting for overdisperion and adjusted for treatment exposure||Tiotropium vs. Salmeterol|
1729296|NCT00563381|3185111|Superiority or Other||Hazard Ratio (HR)|0.83|||<|0.0001||95.0|0.77|0.9|||Regression, Cox|Treatment effect adjusted for pooled centre||Tiotropium versus Salmeterol|
1729297|NCT00563368|3185112|Superiority or Other||Odds Ratio (OR)|9.063|Standard Error of the Mean|3.0857|<|0.0001|2-Sided|95.0|4.65|17.66||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1729298|NCT00563368|3185112|Superiority or Other||Odds Ratio (OR)|2.166|Standard Error of the Mean|0.6158|<|0.0066|2-Sided|95.0|1.241|3.781||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1729299|NCT00563368|3185112|Superiority or Other||Odds Ratio (OR)|2.568|Standard Error of the Mean|0.7391|<|0.0011|2-Sided|95.0|1.46|4.514||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1729300|NCT00563368|3185112|Superiority or Other||Odds Ratio (OR)|10.623|Standard Error of the Mean|3.644|<|0.0001|2-Sided|95.0|5.424|20.81||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1729301|NCT00563368|3185112|Superiority or Other||Odds Ratio (OR)|2.246|Standard Error of the Mean|0.6418|<|0.0046|2-Sided|95.0|1.283|3.932||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1729302|NCT00563368|3185112|Superiority or Other||Odds Ratio (OR)|2.028|Standard Error of the Mean|0.5832|<|0.014|2-Sided|95.0|1.154|3.563||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1729303|NCT00563368|3185113|Superiority or Other||Mean Difference (Final Values)|6.75|Standard Error of the Mean|0.831|<|0.0001|2-Sided|95.0|5.11|8.38||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1729304|NCT00563368|3185113|Superiority or Other||Mean Difference (Final Values)|3.01|Standard Error of the Mean|0.828|<|0.0003|2-Sided|95.0|1.38|4.63||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1729305|NCT00563368|3185113|Superiority or Other||Mean Difference (Final Values)|3.33|Standard Error of the Mean|0.832|<|0.0001|2-Sided|95.0|1.69|4.96||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1729306|NCT00563368|3185113|Superiority or Other||Mean Difference (Final Values)|7.49|Standard Error of the Mean|0.83|<|0.0001|2-Sided|95.0|5.86|9.12||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1729307|NCT00563368|3185113|Superiority or Other||Mean Difference (Final Values)|3.15|Standard Error of the Mean|0.825|<|0.0001|2-Sided|95.0|1.53|4.77||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1729308|NCT00563368|3185113|Superiority or Other||Mean Difference (Final Values)|2.76|Standard Error of the Mean|0.831|<|0.0009|2-Sided|95.0|1.13|4.39||Intersection-union method applied in a step-down testing approach|ANCOVA|||With 100 subjects in each of the seven arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and monotherapy or placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1729309|NCT00563316|3185115|Non-Inferiority or Equivalence|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.897|||||2-Sided|90.0|0.818|0.983|||||Ratio of Cycle 2 : Cycle 1||
1729811|NCT00557245|3186055|Superiority or Other|||||||0.51|||||||Regression, Logistic|Generalized estimating equations with logistic link to account for multiple pregnancies and multiple births|||
1729310|NCT00563316|3185116|Non-Inferiority or Equivalence|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.898|||||2-Sided|90.0|0.819|0.985|||||Ratio of Cycle 2 : Cycle 1||
1729311|NCT00563316|3185117|Non-Inferiority or Equivalence|It would be concluded that panitumumab did not have a clinically important effect on the pharmacokinetics of irinotecan if the 90% confidence intervals of the ratio of geometric means for the Cmax and AUC values for irinotecan with and without concomitant panitumumab administration fell within the interval of 70% to 143%.|Least Squares Geometric Mean Ratio|0.98|||||2-Sided|90.0|0.894|1.074|||||Ratio of Cycle 2 : Cycle 1||
1729312|NCT00563186|3185122|Superiority or Other||Rate Ratio|1.929|Standard Error of the Mean|0.493||0.175|2-Sided|95.0|0.76|4.9|||Large test for person-time analysis||||
1729313|NCT00563186|3185124|Superiority or Other|This statistical analysis applies to the overall VRE, CDI and MRSA infection and colonization events expressed as incidence density (per 1000 patient-days at risk).|Incidence Rate ratio|1.6|Standard Error of the Mean|0.57||0.18|2-Sided|95.0|0.8|3.22|||Poisson||Numerator is novel ward and denominator is traditional ward.|"It was calculated that this study will require 9750 patient days of observation in the traditional design wards and 19,500 patient days of observation in the novel design ward to ensure 80% statistical power to detect a 60% difference in the rates of incident cases of selected HAIs and ARO colonizations (the primary outcome measure) with an α level of 0.05 assuming that incident cases in each unit follow Poisson distribution based on well established historic trends on these units"|
1729314|NCT00562965|3185130|Superiority or Other||Hazard Ratio (HR)|0.3||||0.1727|2-Sided|95.0|0.05|1.81|||Cox proportional hazard regression model|Stratified Cox proportional hazard regression model was utilized.|In this regression model, treatment arm was the covariate and the strata (number of prior regimens, investigator’s choice of therapy and geographical region) over which participants were stratified prior to randomization were the variables.||
1729315|NCT00562965|3185131|Superiority or Other|||||||0.0801|||||||Fisher Exact||||
1729316|NCT00562965|3185132|Superiority or Other||Hazard Ratio (HR)|0.19||||0.0358|2-Sided|95.0|0.04|1.02|||Cox proportional hazard regression model|A 2-sided 5% significance level on a stratified Cox proportional hazard regression model was used.|In this regression model, treatment arm was the covariate and the strata (number of prior regimens, investigator’s choice of therapy and geographical region) over which participants were stratified prior to randomization were the variables.|To detect a hazard ratio of 0.77 with 85% power using a 2-sided log-rank test at the 5% significance level, it was planned that approximately 978 participants were needed to be randomized but due to premature termination only 29 participants were randomized.|
1729317|NCT00562861|3185133|Superiority or Other||F value|1.88||||0.17|2-Sided||||||Mixed Models Analysis||||
1729318|NCT00562627|3185137|Superiority or Other||||||<|0.001|||||||ANOVA||||
1729319|NCT00562627|3185138|Superiority or Other|||||||0.001|||||||ANOVA||||
1729320|NCT00562627|3185139|Superiority or Other|||||||0.009|||||||ANOVA||||
1729321|NCT00562588|3185149|Superiority or Other||Hazard Ratio (HR)|0.725||||0.202||95.0|0.442|1.189|||Cox proportional hazards model|||Early treatment initiation (immediately after the index event) with Aggrenox was compared to late initiation of Aggrenox after 7 days of treatment with ASA mono|
1729322|NCT00562588|3185150|Superiority or Other|||||||0.607|||||||ANCOVA|ANCOVA with factors for treatment, age, weight, baseline SBP, diabetes, previous stroke and baseline NIHSS||Early treatment initiation (immediately after the index event) with Aggrenox was compared to late initiation of Aggrenox after 7 days of treatment with ASA mono|
1729323|NCT00562588|3185151|Superiority or Other||Odds Ratio (OR)|1.067||||0.683||95.0|0.78|1.461|||Regression, Logistic|||The primary endpoint tele-mRS on day 90 was available in 527 of 543 treated patients (97.1%).|
1729324|NCT00562484|3185163|Superiority or Other||Vaccine efficacy|60.0|||||2-Sided|95.0|44.0|72.0||||||Vaccine efficacy = 100 x (1 - ratio of incidence rate)|
1729325|NCT00562484|3185164|Superiority or Other||Vaccine Efficacy|42.0|||||2-Sided|95.0|30.0|52.0||||||Vaccine efficacy = 100 x (1 - ratio of incidence rate)|
1729326|NCT00562354|3185171|Superiority or Other||ratio of geometric mean concentration|0.59|||||2-Sided|95.0|0.42|0.82|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729327|NCT00562354|3185171|Superiority or Other||ratio of geometric mean concentration|0.42|||||2-Sided|95.0|0.29|0.6|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729328|NCT00562354|3185171|Superiority or Other||ratio of geometric mean concentration|0.5|||||2-Sided|95.0|0.38|0.66|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729329|NCT00562354|3185171|Superiority or Other||ratio of geometric mean concentration|0.57|||||2-Sided|95.0|0.43|0.74|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729330|NCT00562354|3185171|Superiority or Other||ratio of geometric mean concentration|0.76|||||2-Sided|95.0|0.56|1.03|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729331|NCT00562354|3185171|Superiority or Other||ratio of geometric mean concentration|0.46|||||2-Sided|95.0|0.35|0.61|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729332|NCT00562354|3185171|Superiority or Other||ratio of geometric mean concentration|0.74|||||2-Sided|95.0|0.56|0.97|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729333|NCT00562354|3185171|Superiority or Other||ratio of geometric mean concentration|0.65|||||2-Sided|95.0|0.48|0.9|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729334|NCT00562354|3185171|Superiority or Other||ratio of geometric mean concentration|0.71|||||2-Sided|95.0|0.52|0.97|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729335|NCT00562354|3185171|Superiority or Other||ratio of geometric mean concentration|0.65|||||2-Sided|95.0|0.5|0.85|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729336|NCT00562354|3185171|Superiority or Other||ratio of geometric mean concentration|0.66|||||2-Sided|95.0|0.48|0.91|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729337|NCT00562354|3185171|Superiority or Other||ratio of geometric mean concentration|0.8|||||2-Sided|95.0|0.63|1.0|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729338|NCT00562354|3185171|Superiority or Other||ratio of geometric mean concentration|0.6|||||2-Sided|95.0|0.43|0.86|||||Ratio of GMCs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of IgG GMCs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729339|NCT00562354|3185174|Superiority or Other||difference in proportions|-7.7|||||2-Sided|95.0|-18.5|3.4||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729340|NCT00562354|3185174|Superiority or Other||difference in proportions|-11.4|||||2-Sided|95.0|-21.7|-1.2||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729341|NCT00562354|3185174|Superiority or Other||difference in proportions|-0.8|||||2-Sided|95.0|-9.8|8.1||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729342|NCT00562354|3185174|Superiority or Other||difference in proportions|-12.2|||||2-Sided|95.0|-22.6|-1.7||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729343|NCT00562354|3185174|Superiority or Other||difference in proportions|-6.4|||||2-Sided|95.0|-18.7|6.1||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729344|NCT00562354|3185174|Superiority or Other||difference in proportions|-26.9|||||2-Sided|95.0|-39.0|-14.1||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729345|NCT00562354|3185174|Superiority or Other||difference in proportions|-9.5|||||2-Sided|95.0|-19.3|0.4||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729346|NCT00562354|3185174|Superiority or Other||difference in proportions|-11.0|||||2-Sided|95.0|-23.8|1.9||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729347|NCT00562354|3185174|Superiority or Other||difference in proportions|-11.9|||||2-Sided|95.0|-22.6|-1.2||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729348|NCT00562354|3185174|Superiority or Other||difference in proportions|-2.3|||||2-Sided|95.0|-11.6|6.9||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1730002|NCT00554515|3186519|Superiority|||||||0.33|||||||Fisher Exact|||Objective response rates were compared between tumor type subgroups|
1729349|NCT00562354|3185174|Superiority or Other||difference in proportions|-18.3|||||2-Sided|95.0|-30.1|-5.9||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729350|NCT00562354|3185174|Superiority or Other||difference in proportions|-5.5|||||2-Sided|95.0|-15.9|5.0||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729351|NCT00562354|3185174|Superiority or Other||difference in proportions|-5.7|||||2-Sided|95.0|-13.8|2.1||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729352|NCT00562354|3185177|Superiority or Other||difference in proportions|-2.5|||||2-Sided|95.0|-12.5|7.3||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729353|NCT00562354|3185177|Superiority or Other||difference in proportions|-3.8|||||2-Sided|95.0|-12.2|4.5||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729354|NCT00562354|3185177|Superiority or Other||difference in proportions|0.8|||||2-Sided|95.0|-6.2|7.9||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729355|NCT00562354|3185177|Superiority or Other||difference in proportions|-10.5|||||2-Sided|95.0|-19.3|-1.3||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729356|NCT00562354|3185177|Superiority or Other||difference in proportions|-9.6|||||2-Sided|95.0|-21.4|2.4||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729357|NCT00562354|3185177|Superiority or Other||difference in proportions|-17.5|||||2-Sided|95.0|-29.5|-5.0||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729358|NCT00562354|3185177|Superiority or Other||difference in proportions|-7.3|||||2-Sided|95.0|-16.3|1.5||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729359|NCT00562354|3185177|Superiority or Other||difference in proportions|-12.9|||||2-Sided|95.0|-24.6|-0.8||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729360|NCT00562354|3185177|Superiority or Other||difference in proportions|-5.1|||||2-Sided|95.0|-14.3|4.0||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729361|NCT00562354|3185177|Superiority or Other||difference in proportions|-4.7|||||2-Sided|95.0|-13.5|3.9||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729362|NCT00562354|3185177|Superiority or Other||difference in proportions|-11.2|||||2-Sided|95.0|-21.4|-1.0||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729363|NCT00562354|3185177|Superiority or Other||difference in proportions|-5.4|||||2-Sided|95.0|-14.5|3.5||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729364|NCT00562354|3185177|Superiority or Other||difference in proportions|-7.2|||||2-Sided|95.0|-15.1|0.3||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729365|NCT00562354|3185180|Superiority or Other||difference in proportions|-6.2|||||2-Sided|95.0|-14.1|1.5||||||Serotype 23F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729366|NCT00562354|3185180|Superiority or Other||difference in proportions|-2.4|||||2-Sided|95.0|-8.8|3.7||||||Serotype 19F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729367|NCT00562354|3185180|Superiority or Other||difference in proportions|0.8|||||2-Sided|95.0|-2.8|4.7||||||Serotype 19A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729368|NCT00562354|3185180|Superiority or Other||difference in proportions|-2.3|||||2-Sided|95.0|-7.6|2.5||||||Serotype 18C: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729369|NCT00562354|3185180|Superiority or Other||difference in proportions|0.0|||||2-Sided|95.0|-4.0|4.1||||||Serotype 14: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729370|NCT00562354|3185180|Superiority or Other||difference in proportions|-0.8|||||2-Sided|95.0|-8.7|6.9||||||Serotype 9V: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1734616|NCT00509392|3193644|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1729371|NCT00562354|3185180|Superiority or Other||difference in proportions|-5.3|||||2-Sided|95.0|-10.8|-0.9||||||Serotype 7F: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729372|NCT00562354|3185180|Superiority or Other||difference in proportions|-1.6|||||2-Sided|95.0|-5.9|2.1||||||Serotype 6B: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729373|NCT00562354|3185180|Superiority or Other||difference in proportions|-1.5|||||2-Sided|95.0|-5.7|2.1||||||Serotype 6A: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729374|NCT00562354|3185180|Superiority or Other||difference in proportions|-5.5|||||2-Sided|95.0|-13.7|2.5||||||Serotype 5: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729375|NCT00562354|3185180|Superiority or Other||difference in proportions|-3.4|||||2-Sided|95.0|-9.6|2.2||||||Serotype 4: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729376|NCT00562354|3185180|Superiority or Other||difference in proportions|-3.9|||||2-Sided|95.0|-11.6|3.5||||||Serotype 3: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729377|NCT00562354|3185180|Superiority or Other||difference in proportions|-4.9|||||2-Sided|95.0|-12.1|2.0||||||Serotype 1: To assess differences between reporting groups exact, 2-sided 95% CIs on the difference in proportions between reporting groups were calculated (50 to 64 years age group minus ≥ 65 years age group).|
1729378|NCT00562354|3185183|Superiority or Other||ratio of geometric mean titer|0.5|||||2-Sided|95.0|0.3|0.79|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 23F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729379|NCT00562354|3185183|Superiority or Other||ratio of geometric mean titer|0.6|||||2-Sided|95.0|0.37|0.88|||||Confidence intervals for the ratio are back transformation of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729380|NCT00562354|3185183|Superiority or Other||ratio of geometric mean titer|0.5|||||2-Sided|95.0|0.34|0.67|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 19A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729381|NCT00562354|3185183|Superiority or Other||ratio of geometric mean titer|0.5|||||2-Sided|95.0|0.35|0.79|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 18C: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729382|NCT00562354|3185183|Superiority or Other||ratio of geometric mean titer|0.7|||||2-Sided|95.0|0.54|1.02|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 14: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729383|NCT00562354|3185183|Superiority or Other||ratio of geometric mean titer|0.7|||||2-Sided|95.0|0.45|1.25|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 9V: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729384|NCT00562354|3185183|Superiority or Other||ratio of geometric mean titer|0.7|||||2-Sided|95.0|0.46|0.95|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 7F: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729385|NCT00562354|3185183|Superiority or Other||ratio of geometric mean titer|0.7|||||2-Sided|95.0|0.52|1.02|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6B: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729386|NCT00562354|3185183|Superiority or Other||ratio of geometric mean titer|0.5|||||2-Sided|95.0|0.37|0.74|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 6A: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729387|NCT00562354|3185183|Superiority or Other||ratio of geometric mean titer|0.6|||||2-Sided|95.0|0.38|0.9|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 5: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729812|NCT00557245|3186056|Superiority or Other|||||||0.66|||||||Regression, Logistic|Generalized estimating equations, logistic link, with robust standard errors.|||
1729388|NCT00562354|3185183|Superiority or Other||ratio of geometric mean titer|0.7|||||2-Sided|95.0|0.5|1.11|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 4: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729389|NCT00562354|3185183|Superiority or Other||ratio of geometric mean titer|0.7|||||2-Sided|95.0|0.54|1.01|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 3: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729390|NCT00562354|3185183|Superiority or Other||ratio of geometric mean titer|0.6|||||2-Sided|95.0|0.39|0.84|||||Ratio of GMTs were calculated by back transformation of the mean difference between age groups on the logarithmic scale.|Serotype 1: To assess differences between reporting groups, 2-sided 95% CIs for the ratio of OPA GMTs were constructed by back transformation of the CIs for the mean difference of the log-transformed assay results computed using the Student t-distribution.|
1729391|NCT00562159|3185213|Superiority or Other||Mean Difference (Final Values)|-0.27|||=|0|2-Sided|95.0|-0.48|-0.05|||ANOVA|Asthma status, treatment group, and site were fixed effects.|||
1729392|NCT00562159|3185214|Superiority or Other||Mean Difference (Final Values)|-0.45|||=|0|2-Sided|95.0|-0.96|0.06|||ANOVA|Asthma status, treatment group, and site were fixed effects.|||
1729393|NCT00562159|3185215|Superiority or Other||Mean Difference (Final Values)|-0.86|||=|0|2-Sided|95.0|-1.46|-0.26|||ANOVA|Asthma status, treatment group, and site were fixed effects.|||
1729394|NCT00562159|3185216|Superiority or Other||Mean Difference (Final Values)|-1.31|||=|0|2-Sided|95.0|-2.22|-0.4|||ANOVA|Asthma status, treatment group, and site were fixed effects.|||
1729395|NCT00562120|3185218|Superiority or Other|||||||0.848||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729396|NCT00562120|3185218|Superiority or Other|||||||0.156||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729397|NCT00562120|3185218|Superiority or Other|||||||0.217||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729398|NCT00562120|3185218|Superiority or Other|||||||0||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729399|NCT00562120|3185218|Superiority or Other|||||||0||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729400|NCT00562120|3185218|Superiority or Other|||||||0||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729401|NCT00562120|3185219|Superiority or Other|||||||0.102||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729402|NCT00562120|3185219|Superiority or Other|||||||0.778||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729403|NCT00562120|3185219|Superiority or Other|||||||0.061||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729404|NCT00562120|3185219|Superiority or Other|||||||0.009||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729405|NCT00562120|3185219|Superiority or Other|||||||0.019||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729406|NCT00562120|3185219|Superiority or Other|||||||0||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Rhinorrhea: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729407|NCT00562120|3185219|Superiority or Other|||||||0.19||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729408|NCT00562120|3185219|Superiority or Other|||||||0.496||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1731479|NCT00543569|3188239|Superiority or Other||Difference|6.4|||||2-Sided|90.0|-1.7|14.6||||||BCAR at Month 6|
1729409|NCT00562120|3185219|Superiority or Other|||||||0.048||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729410|NCT00562120|3185219|Superiority or Other|||||||0.012||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729411|NCT00562120|3185219|Superiority or Other|||||||0.055||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729412|NCT00562120|3185219|Superiority or Other|||||||0||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal Itching: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729413|NCT00562120|3185219|Superiority or Other|||||||0.273||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729414|NCT00562120|3185219|Superiority or Other|||||||0.905||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729415|NCT00562120|3185219|Superiority or Other|||||||0.218||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729416|NCT00562120|3185219|Superiority or Other|||||||0.103||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729417|NCT00562120|3185219|Superiority or Other|||||||0.127||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729418|NCT00562120|3185219|Superiority or Other|||||||0.011||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||Nasal congestion: An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729419|NCT00562120|3185220|Superiority or Other|||||||0.753||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729420|NCT00562120|3185220|Superiority or Other|||||||0.087||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729421|NCT00562120|3185220|Superiority or Other|||||||0.043||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729422|NCT00562120|3185220|Superiority or Other|||||||0.48||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729423|NCT00562120|3185220|Superiority or Other|||||||0.952||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729424|NCT00562120|3185220|Superiority or Other|||||||0.357||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729425|NCT00562120|3185221|Superiority or Other|||||||0.978||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729426|NCT00562120|3185221|Superiority or Other|||||||0.134||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729427|NCT00562120|3185221|Superiority or Other|||||||0.124||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729428|NCT00562120|3185221|Superiority or Other|||||||0.138||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729429|NCT00562120|3185221|Superiority or Other|||||||0.663||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729430|NCT00562120|3185221|Superiority or Other|||||||0.13||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729431|NCT00562120|3185222|Superiority or Other|||||||0.952||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729432|NCT00562120|3185222|Superiority or Other|||||||0.521||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729433|NCT00562120|3185222|Superiority or Other|||||||0.479||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729434|NCT00562120|3185222|Superiority or Other|||||||0.252||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729435|NCT00562120|3185222|Superiority or Other|||||||0.097||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729436|NCT00562120|3185222|Superiority or Other|||||||0.269||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729437|NCT00562120|3185223|Superiority or Other|||||||0.816||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729438|NCT00562120|3185223|Superiority or Other|||||||0.71||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729439|NCT00562120|3185223|Superiority or Other|||||||0.544||||||P-value was based on two-sided test which was underpowered and presented for descriptive purposes only. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729440|NCT00562120|3185223|Superiority or Other|||||||0.229||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729441|NCT00562120|3185223|Superiority or Other|||||||0.134||||||P-value was based on a one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An ANOVA mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729442|NCT00562120|3185223|Superiority or Other|||||||0.302||||||P-value was based on one-sided test. There were no further adjustments for multiplicity.|ANOVA|||An analysis of variance (ANOVA) mixed model was assessed with sequence, period and treatment as fixed effects and participant within sequence as a random effect.|
1729443|NCT00561977|3185237|Superiority or Other|||||||0.14|||||||Mixed Models Analysis|time measurement, treatment group, interaction between time and group term as fixed effect, subject as random effect.||Mean dietary quality score by visit and study group was estimated using SAS PROC MIXED. All analyses were performed using SAS 9.13 (SAS Institute, Cary, NC, USA).|
1729444|NCT00561951|3185245|Superiority or Other||Mean Difference (Final Values)|-0.11||||0.129||95.0|-0.26|0.03|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).|
1729445|NCT00561951|3185245|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.624||95.0|-0.18|0.11|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).|
1729446|NCT00561951|3185247|Superiority or Other||Mean Difference (Final Values)|-0.27||||0.03||95.0|-0.52|-0.03|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).|
1729447|NCT00561951|3185247|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.002||95.0|-0.63|-0.14|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).|
1729448|NCT00561951|3185249|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.002||95.0|-1.09|-0.23|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).|
1729449|NCT00561951|3185249|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.003||95.0|-1.07|-0.22|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).|
1729450|NCT00561951|3185251|Superiority or Other||Mean Difference (Final Values)|-0.66|||<|0.001||95.0|-1.01|-0.32|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).|
1729451|NCT00561951|3185251|Superiority or Other||Mean Difference (Final Values)|-0.56|||<|0.002||95.0|-0.91|-0.22|||ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).|
1729813|NCT00557245|3186056|Superiority or Other|||||||0.32|||||||Regression, Logistic|Generalized estimating equations, logistic link, with robust standard errors.|||
1729452|NCT00561951|3185253|Superiority or Other||Mean Difference (Final Values)|-0.39|||<|0.001||95.0|-0.6|-0.17||The closed testing procedure was used in order to control the probability of a type 1 error.|ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).|
1729453|NCT00561951|3185253|Superiority or Other||Mean Difference (Final Values)|-0.34|||<|0.002||95.0|-0.56|-0.13||The closed testing procedure was used in order to control the probability of a type 1 error.|ANCOVA|Analysis of covariance model with the treatment group, region as fixed effects and baseline values as a covariate was used.||The significance level was 0.05 (2-sided).|
1729454|NCT00561925|3185255|Non-Inferiority or Equivalence|equivalence test with 80% -125% boundaries|adjusted gMean|79.58|Standard Error of the Mean|1.04||0.5542||90.0|74.62|84.86||p-value for ratio outside the interval 80%-125%|ANOVA||Inter-individual gCV = 49.9|adjusted geometric mean ratio NVP XR : NVP IR|
1729455|NCT00561925|3185263|Superiority or Other||Mean Difference (Final Values)|32.87||||0.0078||95.0|8.67|57.06|||ANCOVA|Means adjusted for baseline HIV-1 viral load stratum|||
1729456|NCT00561925|3185264|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.7719||95.0|-0.08|0.06|||ANCOVA|Means adjusted for baseline HIV-1 viral load stratum|||
1729457|NCT00561925|3185266|Non-Inferiority or Equivalence|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -2%|Cochran's statistic|4.84|||<|0.0001||95.0|-1.11|10.79|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.||
1729458|NCT00561925|3185268|Non-Inferiority or Equivalence|Non-inferiority of nevirapine XR to nevirapine IR was established if the lower bound of the confidence interval was greater than -10%|Cochran's statistic|4.9|||<|0.0001||95.0|-0.1|10.0|||Cochran's statistic||Weighted treatment difference and corresponding variance were calculated based on Cochran's statistic.||
1729459|NCT00561821|3185273|Superiority or Other|||||||0.0014||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729460|NCT00561821|3185273|Superiority or Other|||||||0.0316||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729461|NCT00561821|3185273|Superiority or Other|||||||0.0199||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729462|NCT00561821|3185274|Superiority or Other|||||||0.0007||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729463|NCT00561821|3185274|Superiority or Other|||||||0.0242||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729464|NCT00561821|3185274|Superiority or Other|||||||0.0243||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729465|NCT00561821|3185275|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729466|NCT00561821|3185275|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729467|NCT00561821|3185275|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729468|NCT00561821|3185276|Superiority or Other|||||||0.6271||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729469|NCT00561821|3185276|Superiority or Other|||||||0.4153||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729470|NCT00561821|3185276|Superiority or Other|||||||0.4033||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729471|NCT00561821|3185277|Superiority or Other|||||||0.7865||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729472|NCT00561821|3185277|Superiority or Other|||||||0.6355||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729473|NCT00561821|3185277|Superiority or Other|||||||0.6317||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729474|NCT00561821|3185278|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729475|NCT00561821|3185278|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729476|NCT00561821|3185278|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729477|NCT00561821|3185279|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729478|NCT00561821|3185279|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729479|NCT00561821|3185279|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729480|NCT00561821|3185280|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729481|NCT00561821|3185280|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729482|NCT00561821|3185280|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729485|NCT00561821|3185281|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729486|NCT00561821|3185282|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729487|NCT00561821|3185282|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729488|NCT00561821|3185282|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729489|NCT00561821|3185283|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729490|NCT00561821|3185283|Superiority or Other||||||<|0.0003||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729491|NCT00561821|3185283|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729492|NCT00561821|3185284|Superiority or Other|||||||0.0135||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729493|NCT00561821|3185284|Superiority or Other|||||||0.0213||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729494|NCT00561821|3185284|Superiority or Other|||||||0.001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729495|NCT00561821|3185285|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729496|NCT00561821|3185285|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729497|NCT00561821|3185285|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729498|NCT00561821|3185286|Superiority or Other|||||||0.0102||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729499|NCT00561821|3185286|Superiority or Other|||||||0.0234||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729500|NCT00561821|3185286|Superiority or Other|||||||0.0146||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729501|NCT00561821|3185287|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729502|NCT00561821|3185287|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729503|NCT00561821|3185287|Superiority or Other||||||<|0.0001||||||Pairwise comparisons on rank transformed data with effects for treatment and center, and baseline of variable as a covariate|ANCOVA||||
1729504|NCT00561600|3185316|Superiority or Other|||||||0.957|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group|
1729505|NCT00561600|3185317|Superiority or Other|||||||0.061|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group|
1729506|NCT00561600|3185318|Superiority or Other|||||||0.782|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group|
1729507|NCT00561600|3185319|Superiority or Other|||||||0.048|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group|
1729508|NCT00561600|3185320|Superiority or Other|||||||0.689|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group|
1729509|NCT00561600|3185321|Superiority or Other|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group|
1729510|NCT00561600|3185322|Superiority or Other|||||||0.766|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group|
1729511|NCT00561600|3185323|Superiority or Other|||||||0.079|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group|
1729512|NCT00561600|3185324|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group|
1729513|NCT00561600|3185325|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group|
1729514|NCT00561600|3185326|Superiority or Other|||||||0.103|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group|
1729515|NCT00561600|3185327|Superiority or Other|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum Cobalt ions were expected to be lower in the ASR-XL group|
1729516|NCT00561600|3185328|Superiority or Other|||||||0.121|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group|
1734617|NCT00509392|3193645|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1729517|NCT00561600|3185329|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group|
1729518|NCT00561600|3185330|Superiority or Other|||||||0.237|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group|
1729519|NCT00561600|3185331|Superiority or Other|||||||0.005|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group|
1729520|NCT00561600|3185332|Superiority or Other|||||||0.882|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte chromium ions were expected to be lower in the ASR-XL group|
1729521|NCT00561600|3185333|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Erythrocyte cobalt ions were expected to be lower in the ASR-XL group|
1729522|NCT00561600|3185334|Superiority or Other|||||||0.032|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum chromium ions were expected to be lower in the ASR-XL group|
1729523|NCT00561600|3185335|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||HO: Pinnacle=ASR-XL. The alternative hypothesis is HA: Pinnacle≠ASR-XL. Serum cobalt ions were expected to be lower in the ASR-XL group|
1729524|NCT00561600|3185336|Superiority or Other|||||||0.799|||||||Wilcoxon (Mann-Whitney)||||
1729525|NCT00561600|3185337|Superiority or Other|||||||0.869|||||||Wilcoxon (Mann-Whitney)||||
1729526|NCT00561600|3185338|Superiority or Other|||||||0.762|||||||Wilcoxon (Mann-Whitney)||||
1729527|NCT00561600|3185339|Superiority or Other|||||||0.457|||||||Wilcoxon (Mann-Whitney)||||
1729528|NCT00561600|3185342|Superiority or Other|||||||0.167|||||||t-test, 2 sided|Satterthwaite|||
1729529|NCT00561600|3185343|Non-Inferiority or Equivalence|non inferiority of proportion successful with 8% non inferiority margin at 24 months|percentage difference|0.139||||0.872|1-Sided|95.0||0.225|||Chi-squared||The upper confidence limit was a priori determined to be a secondary endpoint|A non-inferiority test of the proportion successful for each treatment group will be the primary test of efficacy in this investigation. The null hypothesis is Ho: Xc-Xt ≥ 0.08 and the alternative hypothesis is HA:Xc-Xt < 0.08 Sample size of 126 per group was needed assuming 93% success rates, this was increased to 150 per group to account for attrition.|
1729530|NCT00561574|3185344|Superiority or Other|||||||0.0004||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729531|NCT00561574|3185344|Superiority or Other|||||||0.0116||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729532|NCT00561574|3185345|Superiority or Other|||||||0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729533|NCT00561574|3185345|Superiority or Other||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729534|NCT00561574|3185346|Superiority or Other||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729535|NCT00561574|3185346|Superiority or Other||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729536|NCT00561574|3185347|Superiority or Other||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729537|NCT00561574|3185347|Superiority or Other||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729538|NCT00561574|3185348|Superiority or Other|||||||0.3154||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729539|NCT00561574|3185348|Superiority or Other|||||||0.3129||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729540|NCT00561574|3185349|Superiority or Other||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729541|NCT00561574|3185349|Superiority or Other||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729542|NCT00561574|3185350|Superiority or Other||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729543|NCT00561574|3185350|Superiority or Other||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729544|NCT00561574|3185351|Superiority or Other||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729545|NCT00561574|3185351|Superiority or Other||||||<|0.0001||||||Two-sided significance level of 0.05|t-test, 2 sided||||
1729546|NCT00561470|3185356|Superiority or Other|||||||0.0001|||||||Stratified Cochran-Mantel-Haenszel|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.|||
1729547|NCT00561470|3185357|Superiority or Other||Stratified Hazard ratio|0.758||||7e-05|2-Sided|99.99|0.578|0.995||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS|Stratified Log-Rank test||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model.||
1729548|NCT00561470|3185358|Superiority or Other||Stratified Hazard Ratio|0.817||||0.0032|2-Sided|95.34|0.713|0.937||Stratified Log-Rank test p-value. Stratified on ECOG Performance Status and prior Bevacizumab according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.|Stratified Log-Rank test||Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.||
1729549|NCT00561080|3185429|Superiority or Other||GMT Ratio|1.08|||||2-Sided|95.0|0.98|1.19|||||GMT Ratio = GMT Group 3/GMT Group 1|ANCOVA model includes country and age at first vaccination as independent variables and baseline antibody titre as covariate. The GMT 12-month post-last dose is the GMT adjusted from the ANCOVA model|
1729550|NCT00561080|3185429|Superiority or Other||GMT Ratio|1.06|||||2-Sided|95.0|0.96|1.17|||||GMT Ratio = Group 2 GMT/Group 1 GMT|ANCOVA model includes country and age at first vaccination as independent variables and baseline antibody titre as covariate. The GMT 12-month post-last dose is the GMT adjusted from the ANCOVA model|
1729551|NCT00561080|3185431|Superiority or Other||GMFR|2.35|||||2-Sided|95.0|2.11|2.62|||||GMFR=GMT Post Dose/GMT Pre Dose||
1729849|NCT00556712|3186156|Superiority or Other||Hazard Ratio (HR)|0.71|||<|0.0001|2-Sided|95.0|0.62|0.82|||Log Rank||||
1729552|NCT00561080|3185432|Non-Inferiority or Equivalence|Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2|GMTR|0.78|||>|0.999|2-Sided|95.0|0.73|0.85|||ANOVA||GMTR = GMT Post Dose 2/GMT Post dose 1||
1729553|NCT00561080|3185432|Non-Inferiority or Equivalence|Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2|Geometric Mean Titer Ratio (GMTR)|1.11|||>|0.948|2-Sided|95.0|1.02|1.22|||ANOVA||GMTR = GMT Post Dose 2/GMT Post dose 1||
1729554|NCT00560937|3185459|Superiority or Other|||||||0.014|||||||t-test, 2 sided||||
1729555|NCT00560937|3185460|Superiority or Other|||||||1|||||||t-test, 2 sided|||T-test of change scores, pregnenolone compared to placebo post-treatment vs. pre-randomization.|
1729556|NCT00560937|3185461|Superiority or Other|||||||0.22|||||||t-test, 2 sided||||
1729557|NCT00560937|3185462|Superiority or Other|||||||0.79|||||||t-test, 2 sided||||
1729558|NCT00560937|3185463|Superiority or Other|||||||0.048|||||||t-test, 2 sided|||T-test of change scores, pregnenolone vs. placebo post-treatment compared to baseline.|
1729559|NCT00560859|3185470|Superiority or Other||difference of change from baseline|2.0||||0.16|||||||ANCOVA||||
1729560|NCT00560833|3185471|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.15|2-Sided|95.0|-0.12|0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729561|NCT00560833|3185471|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.13|2-Sided|95.0|-0.12|0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729562|NCT00560833|3185471|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.72|2-Sided|95.0|-0.09|0.04||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729563|NCT00560833|3185471|Superiority or Other||Mean Difference (Final Values)|0.01||||1|2-Sided|95.0|-0.06|0.07||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729564|NCT00560833|3185472|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.02|2-Sided|95.0|-0.12|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729565|NCT00560833|3185472|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.01|2-Sided|95.0|-0.13|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729566|NCT00560833|3185472|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.02|2-Sided|95.0|-0.12|-0.01||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729567|NCT00560833|3185472|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.62|2-Sided|95.0|-0.09|0.03||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729568|NCT00560833|3185473|Superiority or Other||Mean Difference (Final Values)|-1.5|||<|0.01|2-Sided|95.0|-2.6|-0.5||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729569|NCT00560833|3185473|Superiority or Other||Mean Difference (Final Values)|-1.9|||<|0.01|2-Sided|95.0|-2.9|-0.9||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729570|NCT00560833|3185473|Superiority or Other||Mean Difference (Final Values)|-2.0|||<|0.01|2-Sided|95.0|-3.0|-0.9||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729571|NCT00560833|3185473|Superiority or Other||Mean Difference (Final Values)|-1.0|||<|0.06|2-Sided|95.0|-2.0|0.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729572|NCT00560833|3185475|Superiority or Other||Mean Difference (Final Values)|-1.9|||<|0.01|2-Sided|95.0|-2.9|-1.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729573|NCT00560833|3185475|Superiority or Other||Mean Difference (Final Values)|-1.9|||<|0.01|2-Sided|95.0|-2.9|-1.0||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729574|NCT00560833|3185475|Superiority or Other||Mean Difference (Final Values)|-2.2|||<|0.01|2-Sided|95.0|-3.1|-1.2||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729575|NCT00560833|3185475|Superiority or Other||Mean Difference (Final Values)|-1.4|||<|0.01|2-Sided|95.0|-2.3|-0.4||Dunnet-adjusted from ANCOVA with factors for treatment and (pooled) center and a covariate for baseline value.|ANCOVA||||
1729576|NCT00560794|3185489|Superiority or Other|||||||0||||||The null hypothesis stated that the true MRD response probability (π) ≤ 5%.|1-sided exact binomial test||||
1729577|NCT00560703|3185505|Superiority or Other|||||||0.293|||||||ANCOVA|||It was anticipated that the difference between the treatment groups in mean reduction from baseline in OSDI scores will be approximately 7 points. A pooled standard deviation of 9.0 for the mean change from baseline OSDI score is expected. Under those assumptions a total of approximately 63 evaluable patients (42 COL-101 patients and 21 placebo patients) is sufficient to provide 80% power. The planned enrolment should provide enough evaluable patients to meet these assumptions.|
1729578|NCT00560703|3185506|Non-Inferiority or Equivalence|Power calculation for this endpoint was driven by the assumptions made for the OSDI analysis||||||0.578|||||||ANCOVA||||
1729579|NCT00560612|3185507|Superiority|||||||0.065|||||||t-test, 2 sided||||
1729580|NCT00560612|3185508|Superiority|||||||0.7443|||||||t-test, 2 sided||||
1729581|NCT00560612|3185509|Superiority|||||||0.4583|||||||t-test, 2 sided||||
1729582|NCT00560612|3185510|Superiority|||||||0.7054|||||||t-test, 2 sided||||
1729612|NCT00560417|3185575|Superiority or Other||Mean Difference (Final Values)|13.96|||<|0.001|2-Sided|95.0|5.72|22.19||p-value is for Endpoint Morning Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group|||
1729613|NCT00560417|3185575|Superiority or Other||Mean Difference (Final Values)|4.28|||<|0.179|2-Sided|95.0|-1.97|10.53||p-value is for Endpoint Morning Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group|||
1734618|NCT00509392|3193646|Superiority or Other|||||||0.5761|||||||t-test, 2 sided||||
1729583|NCT00560560|3185535|Superiority or Other||||||>|0.05||||||The final analysis was intended to be a binomial test (death prior to 6 months, yes or no). However, 2 participants in the 30/kg mg group were censored prior to 6 months, so the six month Kaplan and Meier estimates were used for each group instead.|Test of probability of 6 month survival|p-Value >0.05 applies to each group (20 mg/kg and 30 mg/kg). Greenwood's formula was used for standard deviation.||The hypotheses for each group were H0:p=0.45 vs H1:p>0.45. There was one interim analysis for futility for each group based on the method of Case and Morgan. The futility boundary was not crossed for 20/kg mg group, but was crossed for the 30/kg mg group. It was recommended to investigators that participants be discontinued from treatment with 30 mg/kg of figitumumab.|
1729584|NCT00560417|3185569|Superiority or Other||||||<|0.001|||||||ANOVA|Variable = Treatment + Baseline HbA1c Group+ Baseline SU Group|||
1729585|NCT00560417|3185570|Superiority or Other||Mean Difference (Final Values)|-0.38||||0.343|2-Sided|95.0|-1.15|0.4||p-value is for change in body weight at endpoint between ILPS and glargine treatment groups.|ANOVA||||
1729586|NCT00560417|3185570|Superiority or Other|||||||0.041||||||p-value is for the change in body weight at endpoint in the glargine treatment group.|t-test, 2 sided||||
1729587|NCT00560417|3185570|Superiority or Other|||||||0.417||||||p-value is for the change in body weight at endpoint in the ILPS treatment group.|t-test, 2 sided||||
1729588|NCT00560417|3185571|Superiority or Other|||||||0.343||||||p-value is for endpoint.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group (Type III sums of squares)|||
1729589|NCT00560417|3185572|Superiority or Other|||||||0.004||||||p-value is for Nocturnal reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable|||
1729590|NCT00560417|3185572|Superiority or Other|||||||0.006||||||p-value is for Nocturnal reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable|||
1729591|NCT00560417|3185572|Superiority or Other|||||||0.044||||||p-value is for Non-Nocturnal reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable|||
1729592|NCT00560417|3185572|Superiority or Other|||||||0.116||||||p-value is for Non-Nocturnal reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable|||
1729593|NCT00560417|3185572|Superiority or Other|||||||0.57||||||p-value is for All reported episodes rate - Overall.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable|||
1729594|NCT00560417|3185572|Superiority or Other|||||||0.628||||||p-value is for All reported episodes rate - Endpoint.|Negative Binomial regression model|Total hypoglycemia count=Treatment+Baseline HbA1c Group+Baseline SU Group with log of patient's total number of days of exposure as an offset variable|||
1729595|NCT00560417|3185573|Superiority or Other|||||||0.248||||||p-value is for severe hypoglycemic events overall.|Fisher Exact||||
1729596|NCT00560417|3185573|Superiority or Other|||||||0.061||||||p-value is for nocturnal hypoglycemic events overall.|Fisher Exact||||
1729597|NCT00560417|3185573|Superiority or Other|||||||0.013||||||p-value is for nocturnal hypoglycemic events at endpoint.|Fisher Exact||||
1729598|NCT00560417|3185573|Superiority or Other|||||||0.133||||||p-value is for non-nocturnal hypoglycemic events overall.|Fisher Exact||||
1729599|NCT00560417|3185573|Superiority or Other|||||||0.07||||||p-value is for non-nocturnal hypoglycemic events at endpoint.|Fisher Exact||||
1729600|NCT00560417|3185573|Superiority or Other|||||||0.394||||||p-value is for all reported hypoglycemic events overall.|Fisher Exact||||
1729601|NCT00560417|3185573|Superiority or Other|||||||0.826||||||p-value is for all reported hypoglycemic events at endpoint.|Fisher Exact||||
1729602|NCT00560417|3185574|Superiority or Other||Mean Difference (Final Values)|5.99|||<|0.001|2-Sided|95.0|2.82|9.16||p-value is for Endpoint.|ANOVA|Variable = Treatment + Baseline HbA1c Group + Baseline SU Group|||
1729603|NCT00560417|3185574|Superiority or Other||Mean Difference (Final Values)|2.27|||<|0.131|2-Sided|95.0|-0.68|5.22||p-value is for Baseline.|ANOVA|Variable = Treatment + Baseline HbA1c Group + Baseline SU Group|||
1729604|NCT00560417|3185575|Superiority or Other||Mean Difference (Final Values)|11.97|||<|0.001|2-Sided|95.0|5.01|18.93||p-value is for Endpoint Daily Mean Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group|||
1729605|NCT00560417|3185575|Superiority or Other||Mean Difference (Final Values)|7.12|||<|0.021|2-Sided|95.0|1.1|13.14||p-value is for Endpoint Daily Mean Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group|||
1729606|NCT00560417|3185575|Superiority or Other||Mean Difference (Final Values)|7.39|||<|0.015|2-Sided|95.0|1.46|13.32||p-value is for Endpoint Daily Mean 7-Point Blood Glucose.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group|||
1729607|NCT00560417|3185575|Superiority or Other||Mean Difference (Final Values)|-3.03|||<|0.415|2-Sided|95.0|-10.35|4.28||p-value is for Endpoint 0300 Hours.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group|||
1729608|NCT00560417|3185575|Superiority or Other||Mean Difference (Final Values)|14.19|||<|0.002|2-Sided|95.0|5.44|22.94||p-value is for Endpoint Evening Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group|||
1729609|NCT00560417|3185575|Superiority or Other||Mean Difference (Final Values)|10.92|||<|0.003|2-Sided|95.0|3.66|18.19||p-value is for Endpoint Evening Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group|||
1729610|NCT00560417|3185575|Superiority or Other||Mean Difference (Final Values)|8.73|||<|0.051|2-Sided|95.0|-0.04|17.5||p-value is for Endpoint Midday Postprandial.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group|||
1729611|NCT00560417|3185575|Superiority or Other||Mean Difference (Final Values)|3.8|||<|0.325|2-Sided|95.0|-3.79|11.39||p-value is for Endpoint Midday Pre-Meal.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group|||
1729623|NCT00560417|3185577|Superiority or Other||Mean Difference (Final Values)|0.24||||0.003|2-Sided|95.0|0.08|0.39||p-value is for 24 Weeks change.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group|||
1729624|NCT00560417|3185578|Superiority or Other||Mean Difference (Final Values)|0.22||||0.008|2-Sided|95.0|0.06|0.38||p-value is for Endpoint (LOCF)|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group|||
1729625|NCT00560417|3185578|Superiority or Other||Mean Difference (Final Values)|0.24||||0.003|2-Sided|95.0|0.08|0.39||p-value is for 24 weeks.|ANCOVA|Variable = Treatment + Baseline + Baseline HbA1c Group + Baseline SU Group|||
1729626|NCT00560417|3185579|Non-Inferiority or Equivalence|Noninferiority margin was prespecified at 0.4%|Mean Difference (Final Values)|0.22|||||2-Sided|95.0|0.06|0.38|||||||
1729627|NCT00560404|3185598|Non-Inferiority or Equivalence|Mean Hb within target range during efficacy evaluation period within plus or minus 1 g/dL of their reference Hb and between the target range with a non-inferiority limit of -0.15.|Difference of response rates|0.0|||||2-Sided|95.0|0.0|0.2|||||||
1729628|NCT00559988|3185648|Superiority or Other||Hazard Ratio (HR)|1.064||||0.732|2-Sided|95.0|0.75|1.51|||Regression, Cox||||
1729629|NCT00559962|3185649|Superiority or Other||Mean Difference (Final Values)|7.51|||<|0.001|2-Sided|95.0|5.16|9.86||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo|
1729630|NCT00559962|3185649|Superiority or Other||Mean Difference (Final Values)|7.66|||<|0.001|2-Sided|95.0|4.22|11.11||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo|
1729631|NCT00559962|3185649|Superiority or Other||Mean Difference (Final Values)|3.65|||<|0.001|2-Sided|95.0|1.58|5.72||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo|
1729632|NCT00559962|3185649|Superiority or Other||Mean Difference (Final Values)|7.82|||<|0.001|2-Sided|95.0|4.31|11.33||(All comparisons)|ANOVA||||
1729633|NCT00559962|3185649|Superiority or Other||Mean Difference (Final Values)|3.91|||<|0.001|2-Sided|95.0|1.73|6.1||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo|
1729634|NCT00559962|3185649|Superiority or Other||Mean Difference (Final Values)|4.68|||<|0.001|2-Sided|95.0|2.3|7.07||(All comparisons)|ANOVA||||
1729635|NCT00559962|3185649|Superiority or Other||Mean Difference (Final Values)|4.92|||<|0.001|2-Sided|95.0|2.27|7.57||(All comparisons)|ANOVA|||One-way ANOVA to compare the absolute change from baseline to Week 12 in percent hepatic fat between active treatment groups and placebo|
1729636|NCT00559962|3185650|Superiority or Other||Mean Difference (Final Values)|4.68|||<|0.001|2-Sided|95.0|2.3|7.07|||ANOVA|||One-way analysis of variance (ANOVA) to compare the absolute change from baseline to Week 12 in percent hepatic fat between AEGR-755 5 mg and placebo.|
1729637|NCT00559754|3185665|Superiority or Other|||||||1|||||||Fisher Exact||||
1729638|NCT00559754|3185667|Superiority or Other|||||||1|||||||Fisher Exact||||
1729639|NCT00559754|3185668|Superiority or Other|||||||1|||||||Fisher Exact||||
1729640|NCT00559754|3185670|Superiority or Other|||||||0.4254|||||||Fisher Exact||||
1729641|NCT00559754|3185672|Superiority or Other|||||||0.0693|||||||Fisher Exact||||
1729642|NCT00559754|3185673|Superiority or Other|||||||0.3235|||||||Fisher Exact||||
1729643|NCT00559754|3185674|Superiority or Other|||||||0.0074|||||||Fisher Exact||||
1729644|NCT00559754|3185675|Superiority or Other|||||||0.8696|||||||Fisher Exact||||
1729645|NCT00559754|3185676|Superiority or Other|||||||0.223|||||||Fisher Exact||||
1729646|NCT00559754|3185677|Superiority or Other|||||||0.8311|||||||Fisher Exact||||
1729647|NCT00559754|3185678|Superiority or Other|||||||0.6605|||||||Fisher Exact||||
1729648|NCT00559754|3185679|Superiority or Other|||||||0.3613|||||||Fisher Exact||||
1729649|NCT00559754|3185680|Superiority or Other|||||||0.4864|||||||Chi-squared||||
1729650|NCT00559754|3185681|Superiority or Other|||||||0.4915|||||||Fisher Exact||||
1729651|NCT00559377|3185734|Superiority or Other||Spearman Correlation|0.004|||<|0.05|2-Sided||||||Spearman Correlation|||The correlation between IHC values and FMISO uptake were analyzed using Spearman correlation where p values less than 0.05 were considered significant.|
1729652|NCT00559377|3185735|Superiority or Other||Hazard Ratio (HR)|0.99||||0.98|2-Sided||||||Regression, Cox|||This outcome is for comarison of FMISO T:Bmax to progression-free survival|
1729653|NCT00559377|3185735|Superiority or Other||Hazard Ratio (HR)|1.18||||0.58|2-Sided||||||Regression, Cox|||This outcome is for comparison of FMISO Hypoxic Volume to disease-free survival|
1729654|NCT00559377|3185736|Superiority or Other||Hazard Ratio (HR)|1.05||||0.87|2-Sided||||||Regression, Cox|||This outcome is for comparing FMISO T:Bmax to overall survival|
1729655|NCT00559377|3185736|Superiority or Other||Hazard Ratio (HR)|1.27||||0.42|2-Sided||||||Regression, Cox|||This outcome is for comparing FMISO Hypoxic Volume to overall survival|
1729656|NCT00559364|3185739|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Analysis of covariance (ANCOVA) model using treatment group and pooled site as fixed effects and wash-out phase CFA% value as covariate was used.|
1729657|NCT00559273|3185746|Non-Inferiority or Equivalence|MIRCERA treatment was regarded as non-inferior to the darbepoetin alfa reference group if the lower limit of the CI was greater than -0.75 g/dL.|Adjusted Mean Difference|-0.036|Standard Error of the Mean|0.1097|<|0.0001|2-Sided|95.0|-0.252|0.18|||ANCOVA||||
1729658|NCT00559273|3185747|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value <=0.6; alternate hypothesis (H1): p-value >0.6.|
1729659|NCT00559273|3185747|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||The p-value was the probability that the number of responders is greater than or equal to the observed number, although the true response rate was smaller or equal to 60%. Null hypothesis (H0): p-value <=0.6; alternate hypothesis (H1): p-value >0.6.|
1734619|NCT00509392|3193647|Superiority or Other|||||||0.0005|||||||t-test, 2 sided||||
1729660|NCT00559104|3185749|Superiority or Other||Cox Proportional Hazard|0.66||||0.69|2-Sided|95.0|0.09|4.99|||Regression, Cox||"Numerator: Carmustine in the conditioning. Denominator: Irradiation in the conditioning.~Parameter: Hazard ratio. Dispersion: Standard Error of the Hazard Ratio."|Phase II analysis: There was no power calculation.|
1729661|NCT00559104|3185750|Superiority or Other||Cox Proportional Hazard|0.51||||0.51|2-Sided|95.0|0.07|3.79|||Regression, Cox||"Parameter Dispersion Type: Standard Error of the Parameter Estimate, not of the mean.~Standard Error = 1.02475"|There is no power calculation as this is a phase II study. This is an Event-free Survival, in which an event can be Relapse/Progression, or Death. Censoring can be at the End of follow-up date, or at the End of study date.|
1729662|NCT00558792|3185767|Superiority or Other||Difference in Specificity between Doses|-3.4||||0.1662|2-Sided|95.0|-8.2|1.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729663|NCT00558792|3185767|Superiority or Other||Difference in Specificity between Doses|-0.8||||0.7796|2-Sided|95.0|-6.4|4.8||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729664|NCT00558792|3185767|Superiority or Other||Difference in Specificity between Doses|-4.2||||0.0888|2-Sided|95.0|-9.0|0.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729665|NCT00558792|3185768|Superiority or Other||Difference in Sensitivity between Doses|3.0||||0.8292|2-Sided|95.0|-24.1|30.1||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729666|NCT00558792|3185768|Superiority or Other||Difference in Sensitivity between Doses|4.6||||0.7197|2-Sided|95.0|-20.5|29.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729667|NCT00558792|3185768|Superiority or Other||Difference in Sensitivity between Doses|7.6||||0.5843|2-Sided|95.0|-19.6|34.7||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729668|NCT00558792|3185769|Superiority or Other||Difference in Specificity between Doses|-2.4||||0.3217|2-Sided|95.0|-7.2|2.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729669|NCT00558792|3185769|Superiority or Other||Difference in Specificity between Doses|-1.3||||0.6381|2-Sided|95.0|-6.9|4.2||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729670|NCT00558792|3185769|Superiority or Other||Difference in Specifcity between Doses|-3.7||||0.1322|2-Sided|95.0|-8.7|1.2||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729671|NCT00558792|3185770|Superiority or Other||Difference in Sensitivity between Doses|11.1||||0.3664|2-Sided|95.0|-13.3|35.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729672|NCT00558792|3185770|Superiority or Other||Difference in Sensitivity between Doses|-12.6||||0.2857|2-Sided|95.0|-35.7|10.5||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729673|NCT00558792|3185770|Superiority or Other||Difference in Sensitivity between Doses|-1.5||||0.9104|2-Sided|95.0|-27.9|24.8||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729674|NCT00558792|3185771|Superiority or Other||Difference in Specificity between Doses|-3.1||||0.0693|2-Sided|95.0|-6.5|0.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729675|NCT00558792|3185771|Superiority or Other||Difference in Specificity between Doses|1.3||||0.4985|2-Sided|95.0|-2.6|5.3||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729676|NCT00558792|3185771|Superiority or Other||Difference in Specificity between Doses|-1.7||||0.2511|2-Sided|95.0|-4.7|1.3||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729677|NCT00558792|3185772|Superiority or Other||Difference in Sensitivity between Doses|1.9||||0.8893|2-Sided|95.0|-24.6|28.4||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729678|NCT00558792|3185772|Superiority or Other||Difference in Sensitivity between Doses|12.3||||0.3102|2-Sided|95.0|-11.1|35.6||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729679|NCT00558792|3185772|Superiority or Other||Difference in Sensitivity between Doses|14.1||||0.2758|2-Sided|95.0|-11.4|39.6||Study was not powered for diagnostic performance analyses. Sample size was based on quality of visualization of coronary artery segments.|Chi-squared||||
1729680|NCT00558792|3185773|Superiority or Other|||||||0.0371|||||||ANOVA||||
1729681|NCT00558792|3185774|Superiority or Other|||||||0.0044|||||||ANOVA||||
1729682|NCT00558792|3185775|Superiority or Other|||||||0.02|||||||ANOVA||||
1729683|NCT00558792|3185777|Superiority or Other|||||||0.1212|||||||Chi-squared||||
1729684|NCT00558792|3185778|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1729685|NCT00558792|3185779|Superiority or Other|||||||0.0099|||||||Chi-squared||||
1729686|NCT00558753|3185780|Superiority or Other||Interaction Slice F-value|5.04||||0.0254||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 30-day post surgery time point (Slice)|
1729687|NCT00558753|3185780|Superiority or Other||Interaction Slice F-value|3.11||||0.0786||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 3-day post surgery time point (Slice)|
1734620|NCT00509392|3193648|Superiority or Other|||||||0.0036|||||||t-test, 2 sided||||
1729688|NCT00558753|3185780|Superiority or Other||Interaction Slice F-value|5.1||||0.0247||95.0|||||Mixed Models Analysis|||Test of Condition Effect (Placebo v Pregabalin) at the 2-day post surgery time point (Slice)|
1729689|NCT00558753|3185780|Superiority or Other||Interaction Slice F-value|1.04||||0.3097||95.0|||||Mixed Models Analysis|Mixed model test of Condition Effect (Placebo v Pregabalin) at the 1-day post surgery time point (Slice)||Test of Condition Effect (Placebo v Pregabalin) at the 1-day post surgery time point (Slice)|
1729690|NCT00558753|3185780|Superiority or Other||Slope|-4.2||||0.0133||95.0||||Test of condition(Placebo v Pregabalin) main effect.|Mixed Models Analysis|Mixed model with main effects and time by condition interaction.||Mixed model test of condition (Placebo v Pregabalin) main effect.|
1729691|NCT00558753|3185781|Superiority or Other||Independence: Chi-squared|6.05||||0.0139|||||||Chi-squared|||For 6 month followup on incidence of neuropathic pain.|
1729692|NCT00558753|3185781|Superiority or Other||Independence: Chi-squared|10.3||||0.0013||95.0|||||Chi-squared|||For 3 month followup on incidence of neuropathic pain.|
1729693|NCT00558753|3185782|Superiority or Other||Mean Difference (Final Values)|0.63||||0.003||95.0|||||t-test, 2 sided||||
1729694|NCT00558467|3185821|Superiority or Other|||||||0.9389|||||||Cochran-Mantel-Haenszel||||
1729695|NCT00558467|3185822|Superiority or Other|||||||0.7723|||||||Cochran-Mantel-Haenszel||||
1729696|NCT00558467|3185823|Superiority or Other|||||||0.4607|||||||Cochran-Mantel-Haenszel||||
1729697|NCT00558467|3185824|Superiority or Other|||||||0.4852|||||||Cochran-Mantel-Haenszel||||
1729698|NCT00558467|3185825|Superiority or Other|||||||0.7723|||||||Cochran-Mantel-Haenszel||||
1729699|NCT00558467|3185826|Superiority or Other|||||||0.7302|||||||Cochran-Mantel-Haenszel||||
1729700|NCT00558467|3185827|Superiority or Other|||||||0.2664|||||||Cochran-Mantel-Haenszel||||
1729701|NCT00558467|3185828|Superiority or Other|||||||0.6625|||||||Cochran-Mantel-Haenszel||||
1729702|NCT00558467|3185829|Superiority or Other|||||||0.6375|||||||Cochran-Mantel-Haenszel||||
1729703|NCT00558467|3185830|Superiority or Other|||||||0.162|||||||Cochran-Mantel-Haenszel||||
1729704|NCT00558467|3185831|Superiority or Other|||||||0.4944|||||||Cochran-Mantel-Haenszel||||
1729705|NCT00558467|3185832|Superiority or Other|||||||0.0674|||||||Cochran-Mantel-Haenszel||||
1729706|NCT00558467|3185833|Superiority or Other|||||||0.7691|||||||Cochran-Mantel-Haenszel||||
1729707|NCT00558467|3185834|Superiority or Other|||||||0.2274|||||||Cochran-Mantel-Haenszel||||
1729708|NCT00558467|3185835|Superiority or Other|||||||0.1052|||||||Cochran-Mantel-Haenszel||||
1729709|NCT00558467|3185840|Superiority or Other||Least Squares Mean differnce|-0.15||||0.978|2-Sided|95.0|-11.05|10.75|||ANCOVA||||
1729710|NCT00558467|3185841|Superiority or Other||Least square means difference|-5.97|||||2-Sided|95.0|-7.88|-4.06|||||||
1729711|NCT00558467|3185843|Superiority or Other||Least square means difference|-5.3|||||2-Sided|95.0|-7.21|-3.39|||||||
1729712|NCT00558467|3185844|Superiority or Other||Least square means difference|-3.94|||||2-Sided|95.0|-5.81|-2.08|||||||
1729713|NCT00558467|3185845|Superiority or Other||Least Squares mean difference|0.01||||0.996|2-Sided|95.0|-4.95|4.97|||ANCOVA||||
1729714|NCT00558428|3185853|Superiority or Other||Least Squares Mean Difference|-2.68|Standard Error of the Mean|0.64||||95.0|-3.93|-1.43|||||||
1729715|NCT00558428|3185853|Superiority or Other||Least Squares Mean Difference|-1.4|Standard Error of the Mean|0.64||||95.0|-2.66|-0.14|||||||
1729716|NCT00558428|3185853|Superiority or Other||Least Squares Mean Difference|-4.92|Standard Error of the Mean|0.64|<|0.0001||95.0|-6.18|-3.66|||ANCOVA|Adjusted for baseline and country effect|||
1729717|NCT00558428|3185853|Superiority or Other||Least Squares Mean Difference|-3.64|Standard Error of the Mean|0.64|<|0.0001||95.0|-4.9|-2.38|||ANCOVA|Adjusted for baseline and country effect|||
1729718|NCT00558363|3185864|Superiority or Other||||||<|0.001||||||Comparing percentages of participants with PSA doubling: 35% versus 10%|Mantel-Haenszel Chi-Square||||
1729719|NCT00558363|3185865|Superiority or Other||Relative Risk (Hazard Ratio)|0.25|||<|0.001||95.0|0.14|0.45||Comparing 12-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy|Log Rank||Relative risk of dutasteride compared to placebo, derived from Cox proportional hazard model stratified by site cluster and previous therapy||
1729720|NCT00558363|3185866|Superiority or Other||||||<|0.001||||||Comparing percentages of participants with PSA doubling: 57% versus 28%|Mantel-Haenszel Chi-Square||||
1729721|NCT00558363|3185876|Superiority or Other||Relative Risk (Hazard Ratio)|0.34|||<|0.001|2-Sided|95.0|0.23|0.5||Comparing 24-month survival curves (includes time to PSA doubling as well as time to censoring); stratified by site cluster and previous therapy|Log Rank||Relative risk of dutasteride compared to placebo, derived from Cox Proportional Hazard model stratified by site cluster and previous therapy||
1729722|NCT00558259|3185903|Superiority or Other||Hazard Ratio (HR)|1.82|Standard Error of the Mean|0.36||0.0027|2-Sided|95.0|1.23|2.68|||Regression, Cox|||Dabigatran vs. Placebo- Analysis of time to first occurrence of any bleeding event during the treatment period - FAS - as treated|
1729723|NCT00558259|3185903|Superiority or Other||Hazard Ratio (HR)|2.92|Standard Error of the Mean|0.97||0.0013|2-Sided|95.0|1.52|5.6|||Regression, Cox|||Dabigatran vs. Placebo- Analysis of time to first occurrence of a MBE or CRBE during the treatment period - FAS - as treated.|
1729724|NCT00558259|3185903|Superiority or Other||Percentage of participants with events|0.0|||||2-Sided|95.0|0.0|0.56|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in placebo group.||
1729725|NCT00558259|3185903|Superiority or Other||Percentage of participants with events|0.3|||||2-Sided|95.0|0.04|1.05|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing MBE in Dabigatran group.||
1729726|NCT00558259|3185903|Superiority or Other|||||||0.4998||||||As the Cox model did not converge due to too few events, hazard ratios are not estimable.|Fisher Exact|||Dabigatran vs. Placebo - Analysis of time to first occurrence of an MBE during the treatment period - FAS - as treated.|
1729727|NCT00558259|3185904|Superiority or Other||Percentage of participants with events|0.3|||||2-Sided|95.0|0.04|1.09|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in placebo group.||
1729728|NCT00558259|3185904|Superiority or Other||Percentage of participants with events|0.0|||||2-Sided|95.0|0.0|0.54|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants with unexplained death in Dabigatran group.||
1729729|NCT00558259|3185904|Superiority or Other|||||||0.2428|||||||Fisher Exact|||Dabigatran vs. Placebo|
1729730|NCT00558259|3185905|Superiority or Other||Percentage of participants with events|2.1|||||2-Sided|95.0|1.16|3.52|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in placebo group.||
1729731|NCT00558259|3185905|Superiority or Other||Percentage of participants with events|0.1|||||2-Sided|95.0|0.0|0.82|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in Dabigatran group.||
1729732|NCT00558259|3185905|Superiority or Other|||||||0.0004|||||||Fisher Exact|||Dabigatran vs. Placebo|
1729733|NCT00558259|3185906|Superiority or Other||Percentage of participants with events|3.5|||||2-Sided|95.0|2.21|5.17|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in placebo group.||
1729734|NCT00558259|3185906|Superiority or Other||Percentage of participants with events|0.3|||||2-Sided|95.0|0.04|1.06|||||The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing DVT in Dabigatran group.||
1729735|NCT00558259|3185906|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1729736|NCT00558259|3185907|Superiority or Other||Hazard Ratio (HR)|0.08|Standard Error of the Mean|0.05|<|0.0001||95.0|0.03|0.27|||Regression, Cox|||Dabigatran vs placebo|
1729737|NCT00558259|3185908|Superiority or Other||Hazard Ratio (HR)|0.08|Standard Error of the Mean|0.05|<|0.0001||95.0|0.02|0.25|||Regression, Cox|||Dabigatran vs placebo|
1729738|NCT00558246|3185909|Superiority or Other|||||||0.5078|||||||McNemar||||
1729739|NCT00558246|3185910|Superiority or Other|||||||0.2266|||||||McNemar||||
1729740|NCT00558246|3185911|Superiority or Other|||||||1|||||||McNemar||||
1729741|NCT00558246|3185912|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1729742|NCT00558246|3185913|Non-Inferiority or Equivalence|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|Differences in proportion of successes|0.0||||1|2-Sided|95.0|-5.9|5.9|||McNemar||The level of significance for statistical testing was 0.05 for this study.||
1729743|NCT00558103|3185917|Superiority or Other||Difference in percentage of participants|27.0||||0.116|2-Sided|90.0|2.3|52.0|||Fisher Exact||The estimated value represents the percent difference in the percentage of participants with CR and PR.||
1729744|NCT00558103|3185917|Superiority or Other||Difference in percentage of participants|11.0||||0.485|2-Sided|90.0|-8.3|29.7|||Fisher Exact||The estimated value represents the percent difference in the percentage of participants with CR and PR.||
1729745|NCT00558103|3185917|Superiority or Other||Percentage of participants|58.0|||<|0.001|2-Sided|90.0|43.3|71.5||Comparision of participants receiving lapatanib 1000 mg + pazopanib 400 mg to 10% historical response rate|t-test, 1 sided||The estimated value represents the percentage of participants receiving lapatanib 1000 mg + pazopanib 400 mg with CR and PR.||
1729746|NCT00558103|3185917|Superiority or Other||Percentage of participants|31.0|||<||2-Sided|90.0|11.3|57.3|||||The estimated value represents the percentage of participants with CR and PR.||
1729747|NCT00558103|3185917|Superiority or Other||Percentage of participants|47.0|||<|0.001|2-Sided|90.0|32.8|62.1||Comparision of participants receiving lapatanib 1500 mg + placebo to historical control of 10% response rate|t-test, 1 sided||The estimated value represents the percentage of participants receiving lapatanib 1500 mg + placebo with CR and PR.||
1729748|NCT00558103|3185917|Superiority or Other||Percentage of participants|45.0|||<||2-Sided|90.0|30.9|59.3|||||The estimated value represents the percentage of participants with CR and PR.||
1729749|NCT00558103|3185917|Superiority or Other||Percentage of participants|29.0|||<||2-Sided|90.0|17.2|43.3|||||The estimated value represents the percentage of participants with CR and PR.||
1729750|NCT00558064|3185925|Superiority or Other||Mean Difference (Final Values)|5.11|Standard Error of the Mean|0.57|<|0.0001|2-Sided|95.0|3.98|6.23|||Mixed Models Analysis||Difference calculated as telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination minus amlodipine 5 mg monotherapy||
1729751|NCT00558025|3185927|Superiority or Other|||||||0.619|||||||Cochran-Mantel-Haenszel|test with stratification by country|||
1729752|NCT00558025|3185928|Superiority or Other|||||||0.1299|||||||Cochran-Mantel-Haenszel|test with stratification by country|||
1729753|NCT00558025|3185929|Superiority or Other|||||||0.1623|||||||Cochran-Mantel-Haenszel|test with stratification by country|||
1729754|NCT00558025|3185930|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.1804||95.0|-2.3|0.4|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate|||
1729755|NCT00558025|3185931|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.4694||95.0|-0.8|0.4|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate|||
1729756|NCT00558025|3185932|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.2061||95.0|-2.8|0.6|||ANCOVA|ANCOVA with factors of treatment, country and baseline as covariate|||
1729757|NCT00558025|3185933|Superiority or Other|||||||0.0803|||||||Cochran-Mantel-Haenszel|test with stratification by country|||
1729758|NCT00558025|3185933|Non-Inferiority or Equivalence|Non-inferiority margin: -15 %, power: 80%|Risk Difference (RD)|-10.75||||||95.0|-20.51|1.48||||||Successfully switched patients|
1729759|NCT00557947|3185936|Superiority or Other|||||||1|||||||McNemar||||
1729760|NCT00557947|3185937|Superiority or Other|||||||0.7539|||||||McNemar||||
1729761|NCT00557947|3185938|Superiority or Other|||||||0.3877|||||||McNemar||||
1729762|NCT00557947|3185939|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1729763|NCT00557947|3185940|Non-Inferiority or Equivalence|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.|difference proportions of successes (%)|4.8||||0.2188|2-Sided|95.0|0.0|10.9|||McNemar||The level of significance for statistical testing was 0.05 for this study.||
1729764|NCT00557440|3186017|Superiority or Other||LS Mean Difference|0.165|Standard Error of the Mean|0.0492||0.001|2-Sided|95.0|0.066|0.263||Statistical significance (two-sided) at 5% level. p-values were not corrected for multiplicity.|ANCOVA|Treatment, period, sequence and center as fixed effects, period baseline FEV1 as a covariate, and patient nested within sequence as a random effect.|||
1729765|NCT00557362|3186018|Superiority or Other||Mean Difference (Net)|-0.06||||0.53|2-Sided|95.0|-0.26|0.14|||Regression, Linear||||
1729766|NCT00557362|3186019|Superiority or Other||Mean Difference (Net)|-0.2||||0.26|2-Sided|95.0|-0.57|0.17|||Regression, Linear|||Best spectacle-corrected visual acuity (BSCVA) was evaluated in a linear regression model with enrollment BSCVA and treatment arm as covariates in a subgroup of ulcers caused by Aspergillus spp.|
1729767|NCT00557362|3186019|Superiority or Other||Mean Difference (Net)|0.08||||0.62|2-Sided|95.0|-0.25|0.41|||Regression, Linear|||Best spectacle-corrected visual acuity (BSCVA) was examined in a linear regression model with enrollment BSCVA and treatment arm as covariates among a subgroup of ulcers caused by Fusarium spp.|
1729768|NCT00557362|3186020|Superiority or Other||Mean Difference (Net)|0.17||||0.37|2-Sided|95.0|-0.2|0.53|||Regression, Linear||||
1729769|NCT00557362|3186021|Superiority or Other||Hazard Ratio (HR)|1.23||||0.4|2-Sided|95.0|0.76|2.02|||Regression, Cox||||
1729770|NCT00557362|3186022|Superiority or Other||Mean Difference (Net)|-0.098||||0.29|2-Sided|95.0|-0.28|0.083|||Regression, Linear|Multiple linear regression model adjusted for enrollment BSCVA and corneal de-epithelialization|||
1729771|NCT00557310|3186027|Superiority or Other|||||||0.016||||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements||||
1729772|NCT00557310|3186027|Superiority or Other|||||||0.012||||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements||||
1729773|NCT00557310|3186027|Superiority or Other|||||||0.012||||||P-value is for the percent change from baseline at 3 months.|Mixed Model Repeated Measurements||||
1729774|NCT00557310|3186028|Superiority or Other||||||<|0.001||||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements||||
1729775|NCT00557310|3186028|Superiority or Other||||||<|0.001||||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements||||
1729776|NCT00557310|3186028|Superiority or Other||||||<|0.001||||||P-value is for the percent change from baseline at 3 months.|Mixed Model Repeated Measurements||||
1729777|NCT00557310|3186029|Superiority or Other|||||||0.436||||||P-value is for the percent change from baseline at 24 months.|ANOVA||||
1729778|NCT00557310|3186029|Superiority or Other|||||||0.106||||||P-value is for the percent change from baseline at 18 months.|ANOVA||||
1729779|NCT00557310|3186030|Superiority or Other|||||||0.005||||||P-value is for the percent change from baseline at 24 months.|ANOVA||||
1729780|NCT00557310|3186030|Superiority or Other|||||||0.013||||||P-value is for the percent change from baseline at 18 months.|ANOVA||||
1729781|NCT00557310|3186031|Superiority or Other|||||||0.092||||||P-value is for the percent change from baseline at 24 months.|ANOVA||||
1729782|NCT00557310|3186031|Superiority or Other|||||||0.7||||||P-value is for the percent change from baseline at 18 months.|ANOVA||||
1729783|NCT00557310|3186032|Superiority or Other|||||||0.049||||||P-value is for the percent change from baseline at 24 months.|ANOVA||||
1729784|NCT00557310|3186032|Superiority or Other|||||||0.011||||||P-value is for the percent change from baseline at 18 months.|ANOVA||||
1729785|NCT00557310|3186033|Superiority or Other||||||<|0.001||||||P-value is for the percent change from baseline at 24 months.|ANOVA||||
1729786|NCT00557310|3186033|Superiority or Other||||||<|0.001||||||P-value is for the percent change from baseline at 18 months.|ANOVA||||
1729787|NCT00557310|3186034|Superiority or Other|||||||0.045|||||||ANOVA||||
1729788|NCT00557310|3186035|Superiority or Other||||||<|0.001|||||||ANOVA||||
1729789|NCT00557310|3186036|Superiority or Other|||||||0.021|||||||ANOVA||||
1729790|NCT00557310|3186037|Superiority or Other||||||<|0.001|||||||ANOVA||||
1729791|NCT00557310|3186038|Superiority or Other|||||||0.837||||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements||||
1729792|NCT00557310|3186038|Superiority or Other|||||||0.363|||||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 18 months.|||
1729793|NCT00557310|3186038|Superiority or Other|||||||0.61||||||P-value is for the percent change from baseline at 12 months.|Mixed Model Repeated Measurements||||
1729794|NCT00557310|3186038|Superiority or Other|||||||0.916||||||P-value is for the percent change from baseline at 6 months.|Mixed Model Repeated Measurements||||
1729795|NCT00557310|3186038|Superiority or Other|||||||0.335|||||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 3 months.|||
1729796|NCT00557310|3186039|Superiority or Other|||||||0.212||||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements||||
1729797|NCT00557310|3186039|Superiority or Other|||||||0.847|||||||Mixed Model Repeated Measurements|P-value is for the percent change from baseline at 18 months.|||
1729798|NCT00557310|3186040|Superiority or Other|||||||0.089||||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measures||||
1729799|NCT00557310|3186040|Superiority or Other|||||||0.324||||||P-value is for the percent change from baseline at 18 months.|Mixed Model Repeated Measures||||
1729800|NCT00557310|3186041|Superiority or Other|||||||0.934||||||P-value is for the percent change from baseline at 24 months.|Mixed Model Repeated Measurements||||
1729801|NCT00557310|3186041|Superiority or Other|||||||0.816||||||P-value is for the percent change from baseline at 18 months.|Mixed Model Repeated Measurements||||
1729802|NCT00557310|3186042|Superiority or Other|||||||0.837|||||||Mixed Model Repeated Measurements||||
1729803|NCT00557310|3186043|Superiority or Other|||||||0.363|||||||Mixed Model Repeated Measurements||||
1729804|NCT00557245|3186052|Superiority or Other|||||||0.008|||||||Mixed Models Analysis|Linear mixed effects model|||
1729805|NCT00557245|3186052|Superiority or Other|||||||0.35|||||||Mixed Models Analysis|Linear mixed effects model|||
1729806|NCT00557245|3186053|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Linear mixed effects model|||
1729814|NCT00557245|3186057|Superiority or Other|||||||0.49|||||||Regression, Logistic|Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.|||
1729815|NCT00557245|3186057|Superiority or Other|||||||0.24|||||||Regression, Logistic|Generalized estimating equations, with logistic link and robust standard errors to adjust for individual correlation over time.|||
1729816|NCT00557245|3186061|Superiority or Other|||||||0.89|||||||Fisher Exact||||
1729817|NCT00557245|3186061|Superiority or Other|||||||1|||||||Fisher Exact||||
1729818|NCT00557245|3186062|Superiority or Other||Hazard Ratio (HR)|0.25|||<|0.001|2-Sided|95.0|0.13|0.45||The a priori threshold was 0.05.|Regression, Cox||Placebo arm is the reference group.|We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.|
1729819|NCT00557245|3186062|Superiority or Other||Hazard Ratio (HR)|0.33|||<|0.001|2-Sided|95.0|0.19|0.56||The a priori threshold was 0.05.|Regression, Cox||Placebo arm is the reference group.|We used Cox regression stratified according to site, to estimate the relative rates of time to first positive HIV-1 serologic test.|
1729820|NCT00557193|3186075|Superiority||Hazard Ratio (HR)|1.107||||0.672|1-Sided|85.0||1.403||A priori significance level threshold of alpha=0.15|Log Rank||Arm C is the numerator and Arm B is the denominator of the estimated hazard ratio|A one-sided log rank test will be used for testing whether the EFS in Arm C (chemo+lest) at DL2 is greater than the EFS in Arm B (chemo). This is equivalent to testing the null hypothesis of hazard ratio (HR)=1 versus the alternative of HR<1.|
1729821|NCT00557076|3186077|Superiority or Other||Slope|-0.63|Standard Error of the Mean|0.2||0.0022|2-Sided|||||To confirm that CNC results were not an anomaly at the final measurement and that the overall CNC response pattern was consistent, mixed-effect longitudinal models were conducted.|t-test, 1 sided||The Baseline CNC measure and seven post-Baseline CNC measures (for a total of eight CNC measures) were used to calculate the slope.||
1729822|NCT00557076|3186077|Superiority or Other||Mean Difference (Final Values)|-0.76|Standard Error of the Mean|0.346||0.049|2-Sided|95.0|-1.51|-0.00493|||t-test, 1 sided|CNC scores were transformed to interval level measures using Rasch partial credit and Facets models. We then re-scaled these logits to 0-100 scales.|The mean difference was calculated for each group using the eighth CNC measure minus the Baseline CNC measure.|Power was not calculated for the CNC because the effect size was not published.|
1729823|NCT00557076|3186078|Non-Inferiority or Equivalence|Because 50% of the planned sample size was randomized, achieved power for the DOCS is 0.51.|Mean Difference (Final Values)|5.4|Standard Error of the Mean|7.0||0.465|2-Sided|95.0|-11.1|21.9|||t-test, 1 sided|DOCS scores were transformed to interval level measures using a many-faceted Rasch model anchored to values from a larger validation data set|The mean difference between the baseline and endpoint DOCS test was compared between the FAST and Sham groups.|The planned sample of 15 per group provided 80% power for a one-sided t-test to detect be-tween group endpoint differences in DOCS averages equivalent to an effect size of .91 (9 units). Clinically, this assumes that the FAST protocol would facilitate progression from one clinical state to another (e.g., vegetative (VS) to minimally conscious (MCS) states). The hypothesized effect was based on average DOCS change for a severe TBI sample receiving three weeks of acute rehabilitation.|
1729824|NCT00556933|3186108|Superiority or Other|||||||0.4|||||||Kruskal-Wallis||||
1729825|NCT00556933|3186109|Superiority or Other|||||||0.21|||||||Fisher Exact||||
1729826|NCT00556933|3186110|Superiority or Other|||||||0.67|||||||Fisher Exact||||
1729827|NCT00556933|3186111|Superiority or Other|||||||0.068|||||||Kruskal-Wallis||||
1729828|NCT00556933|3186112|Superiority or Other|||||||0.871|||||||Fisher Exact||||
1729829|NCT00556933|3186113|Superiority or Other|||||||0.422|||||||Fisher Exact||||
1729830|NCT00556933|3186114|Superiority or Other|||||||0.193|||||||Fisher Exact||||
1729831|NCT00556933|3186115|Superiority or Other|||||||0.67|||||||Kaplan-Meier||||
1729832|NCT00556933|3186116|Superiority or Other|||||||0.463|||||||Fisher Exact||||
1729833|NCT00556933|3186117|Superiority or Other|||||||0.53|||||||Fisher Exact||||
1729834|NCT00556933|3186118|Superiority or Other|||||||0.45|||||||General Linear Model||||
1729835|NCT00556933|3186119|Superiority or Other|||||||0.0004|||||||Chi-squared||||
1729836|NCT00556712|3186125|Superiority or Other||Hazard Ratio (HR)|0.96||||0.653|2-Sided|95.0|0.79|1.16|||Log Rank||||
1729837|NCT00556712|3186128|Superiority or Other||Hazard Ratio (HR)|1.06||||0.5385|2-Sided|95.0|0.87|1.31|||Log Rank||||
1729838|NCT00556712|3186131|Superiority or Other||Hazard Ratio (HR)|0.69|||<|0.0001|2-Sided|95.0|0.58|0.82|||Log Rank||||
1729839|NCT00556712|3186133|Superiority or Other||Hazard Ratio (HR)|0.91||||0.3787|2-Sided|95.0|0.74|1.12|||Log Rank||||
1729840|NCT00556712|3186135|Superiority or Other||Difference in Disease Control Rates|13.4|||<|0.0001|2-Sided|95.0|7.1|19.7|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|Analysis included CR + PR + SD > 12 weeks rate.|
1729841|NCT00556712|3186135|Superiority or Other||Difference in Disease Control Rates|9.8|||<|0.0035|2-Sided|95.0|3.1|16.4|||Chi-squared||Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.|Analysis included CR + PR + SD rate.|
1729842|NCT00556712|3186137|Superiority or Other||Difference in Response Upgrade Rates|4.2||||0.0007|2-Sided|95.0|1.6|6.7|||Chi-squared||The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.||
1729843|NCT00556712|3186139|Superiority or Other||Difference in Response Rates|6.53||||0.0006|2-Sided|95.0|2.7|10.3|||Chi-squared||The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method.||
1729844|NCT00556712|3186141|Superiority or Other||Hazard Ratio (HR)|0.7|||<|0.0001|2-Sided|95.0|0.61|0.82|||Log Rank||||
1729845|NCT00556712|3186143|Superiority or Other||Hazard Ratio (HR)|0.83||||0.4797|2-Sided|95.0|0.49|1.4|||Log Rank||||
1729846|NCT00556712|3186146|Superiority or Other||Hazard Ratio (HR)|0.77||||0.1768|2-Sided|95.0|0.51|1.14|||Log Rank||||
1729847|NCT00556712|3186149|Superiority or Other||Hazard Ratio (HR)|0.78||||0.005|2-Sided|95.0|0.66|0.93|||Log Rank||||
1729848|NCT00556712|3186152|Superiority or Other||Hazard Ratio (HR)|0.83||||0.0097|2-Sided|95.0|0.72|0.96|||Log Rank||||
1729850|NCT00556673|3186172|Superiority or Other||LS Mean Difference|0.39|||<|0.0001|2-Sided|90.0|0.28|0.51||"Linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.~A significance level of 5% was used to determine statistical significance."|1-sided|||The primary hypothesis tested was that the change from period baseline of trough FEV1 for placebo and indacaterol/mometasone was equal. The one-sided alternative was that the increase from period baseline of trough FEV1 for indacaterol/mometasone was higher than for placebo.|
1729851|NCT00556543|3186183|Non-Inferiority or Equivalence|No power calculation performed.||||||0.19|||||||Fisher Exact|||Fisher's Exact Test with the null hypothesis that the proportion with adverse events was the same in both groups.|
1729852|NCT00556478|3186205|Superiority or Other||Mean Difference (Final Values)|2.5|||<|0.0001|2-Sided|95.0|1.86|3.2|||ANCOVA|||IPE domain distress|
1729853|NCT00556478|3186205|Superiority or Other||Mean Difference (Final Values)|4.6|||<|0.0001|2-Sided|95.0|3.3|5.84|||ANCOVA|||IPE domain sexual satisfaction|
1729854|NCT00556478|3186205|Superiority or Other||Mean Difference (Final Values)|5.0|||<|0.0001|2-Sided|95.0|3.61|6.34|||ANCOVA|||Analysis of IPE domain ejaculatory control|
1729855|NCT00556478|3186206|Superiority or Other||Ratio (over 3 months/Baseline)|3.05|||<|0.0001|2-Sided|95.0|2.29|4.06|||ANCOVA||||
1729856|NCT00556439|3186211|Other|Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||||0.853||||||The p value of 0.853 reflects comparison of relapse free survival of abatacept versus placebo in Takayasu arteritis.|Log Rank|||The planned sample size was determined by the minimally clinically meaningful result (i.e., an approximate 30% improvement in relapse-free survival) to be detected utilizing a one-sided alpha of 0.1. Kaplan-Meier curves of RFS were constructed for each stratum, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.|
1729857|NCT00556439|3186211|Other|Kaplan-Meier curves of relapse free survival were constructed, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.||||||0.049||||||The p value of 0.049 reflects comparison of relapse free survival of abatacept versus placebo in giant cell arteritis.|Log Rank|||The planned sample size was determined by the minimally clinically meaningful result (i.e., an approximate 30% improvement in relapse-free survival) to be detected utilizing a one-sided alpha of 0.1. Kaplan-Meier curves of RFS were constructed for each stratum, and differences in treatment arms compared using the logrank test. The analysis of the primary outcome was based upon intent to treat.|
1729858|NCT00556374|3186222|Superiority||Hazard Ratio (HR)|0.816||||0.0515|2-Sided|95.0|0.66|1.0|||Cox Proportional Hazard Model|Stratified by randomization strata (hospital type, use of aromatase inhibitor, baseline lumbar spine BMD).|From the Cox Proportional hazard model with treatment fitted as a covariate and stratified by randomization strata. A hazard ratio < 1.0 indicates a lower average event rate and a longer disease-free time for denosumab relative to placebo.||
1729859|NCT00556374|3186223|Superiority or Other (legacy)||Odds Ratio (OR)|0.54||||0.007|2-Sided|95.0|0.34|0.84|||Regression, Logistic|Logistic regression model includes treatment groups as the independent variable and stratified by the randomization stratification factors.|Values < 1 for odds ratio favor denosumab.||
1729860|NCT00556374|3186224|Superiority or Other (legacy)||Odds Ratio (OR)|0.53||||0.0088|2-Sided|95.0|0.33|0.85|||Regression, Logistic|Logistic regression model includes treatment groups as the independent variable and stratified by the randomization stratification factors.|Values < 1 for odds ratio favor denosumab.||
1729861|NCT00556374|3186225|Superiority or Other (legacy)||Difference from Placebo|6.51|||<|0.0001|2-Sided|95.0|5.62|7.39||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.|||
1729862|NCT00556374|3186226|Superiority or Other (legacy)||Difference from Placebo|7.92|||<|0.0001|2-Sided|95.0|6.87|8.97||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.|||
1729863|NCT00556374|3186227|Superiority or Other (legacy)||Difference from Placebo|10.02|||<|0.0001|2-Sided|95.0|9.04|11.01||The Hochberg procedure was used to control for multiplicity.|ANCOVA|Model includes treatment group as the independent variable and adjusted for baseline value and the randomization stratification factors.|||
1729864|NCT00556374|3186228|Superiority or Other (legacy)||Hazard Ratio (HR)|0.504|||<|0.0001|2-Sided|95.0|0.39|0.65|||Cox Proportional Hazard Model|Stratification factors are hospital type, prior use of aromatase inhibitor, and baseline lumbar spine BMD.|From the Cox proportional hazard model with treatment as the independent variable and stratified by randomization strata. A hazard ratio < 1.0 indicates a lower average event rate and a longer fracture-free time for denosumab relative to placebo.|The efficacy clinical hypothesis is that denosumab, when administered subcutaneously at a dose of 60 mg every 6 months, will be considered efficacious in patients with non-metastatic breast cancer receiving AIT if the rate of first clinical fracture in denosumab-treated patients is lower than that in placebo-treated patients. It is anticipated that denosumab will reduce the rate by 30% compared with placebo (ie, the true hazard ratio of denosumab compared with placebo is 0.70).|
1729865|NCT00556322|3186230|Superiority or Other||Hazard Ratio (HR)|1.25||||0.1063|2-Sided|95.0|0.95|1.66|||Log Rank||||
1729866|NCT00556322|3186233|Superiority or Other||Hazard Ratio (HR)|1.19||||0.2202|2-Sided|95.0|0.9|1.57|||Log Rank||||
1729867|NCT00556322|3186236|Superiority or Other||Hazard Ratio (HR)|1.21||||0.1498|2-Sided|95.0|0.93|1.59|||Log Rank||||
1729868|NCT00556322|3186238|Superiority or Other||Difference in Response Rates|1.55||||0.5349|2-Sided|95.0|-3.6|6.7||p-values are based on non-stratified analysis|Chi-squared||Approximate 95% CI for the difference of two rates was determined using Hauck-Anderson Method||
1729869|NCT00556322|3186240|Superiority or Other||Hazard Ratio (HR)|1.02||||0.9403|2-Sided|95.0|0.61|1.69|||Log Rank|||Comparison of EGFR negative populations|
1729870|NCT00556322|3186240|Superiority or Other||Hazard Ratio (HR)|1.26||||0.0662|2-Sided|95.0|0.98|1.61|||Log Rank|||Comparison of EGFR positive populations|
1729871|NCT00556322|3186243|Superiority or Other||Hazard Ratio (HR)|1.19||||0.0885|2-Sided|95.0|0.97|1.46|||Log Rank||||
1729875|NCT00555971|3186266|Equivalence|This was a statistical analysis to address the null hypothesis that there was no difference between treatment and placebo groups.||||||0.036|||||||Fisher Exact||||
1729876|NCT00555880|3186288|Superiority or Other (legacy)|||||||0.0342|||||||Signed Rank Test|||Analysis of treatment|
1729877|NCT00555880|3186293|Superiority or Other (legacy)||Least squares mean|92.4||||0.0296|2-Sided|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA||Least squares mean for treatment difference (Midodrine HCl – Placebo)|Analysis of treatment difference|
1729878|NCT00555880|3186295|Superiority or Other (legacy)|||||||0.0108|||||||ANOVA|||Final diastolic pressure-Analysis of treatment|
1729879|NCT00555880|3186295|Superiority or Other (legacy)|||||||0.0378||||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Final systolic pressure-Analysis of treatment|
1729880|NCT00555880|3186298|Superiority or Other (legacy)|||||||0.6439||||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Head/Neck Discomfort-Analysis of treatment|
1729881|NCT00555880|3186298|Superiority or Other (legacy)|||||||0.088||||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Trouble Concentrating-Analysis of treatment|
1729882|NCT00555880|3186298|Superiority or Other (legacy)|||||||0.282||||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Fatigue-Analysis of treatment|
1729883|NCT00555880|3186298|Superiority or Other (legacy)|||||||0.0727||||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Weakness-Analysis of treatment|
1729884|NCT00555880|3186298|Superiority or Other (legacy)|||||||0.0191||||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Problems with Vision-Analysis of treatment|
1729885|NCT00555880|3186298|Superiority or Other (legacy)|||||||0.0633||||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA|||Item Dizziness, Lightheadedness, and Feeling Faint-Analysis of treatment|
1729886|NCT00555880|3186299|Superiority or Other (legacy)||Least squares mean|-5.7||||0.059|2-Sided|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period, and treatment as fixed effects and subject within sequence as a random effect.|ANOVA||Least squares mean for treatment difference (Midodrine HCl – Placebo)|Analysis of treatment|
1729887|NCT00555880|3186300|Superiority or Other (legacy)|||||||0.9479||||||The P-value is from a 2-sample t-test for difference in mean|t-test, 2 sided||||
1729888|NCT00555880|3186301|Superiority or Other (legacy)||Least squares mean|91.1||||0.1928|2-Sided|||||The P-value is based on type III sum of squares for treatment group from a one-way ANOVA model|ANOVA||Least squares mean for treatment difference (Midodrine HCL-Placebo)||
1729889|NCT00555880|3186302|Superiority or Other (legacy)||Least squares mean|97.9||||0.0418|2-Sided|||||The P-value is based on type III sum of squares for treatment group from a mixed effect ANOVA model with sequence, period and treatment as fixed effects, and subject within sequence as a random effect|ANOVA||Least squares mean for treatment difference (Midodrine HCL-Placebo)|Analysis of treatment difference|
1729890|NCT00555880|3186303|Superiority or Other (legacy)||Sign statistic|2.5||||0.2266|2-Sided||||||Sign test||Sign test was performed per analysis plan.||
1729891|NCT00555880|3186304|Superiority or Other (legacy)||Sign Statistic|3.0||||0.146|2-Sided||||||Sign test||Sign test was performed per analysis plan.||
1729892|NCT00555672|3186320|Superiority or Other||Objective Response Rate (ORR) (percent)|27.3|||||2-Sided|95.0|13.3|45.5|||||||
1729893|NCT00555360|3186386|Superiority or Other||Difference in Percent|14.0|Standard Deviation|6.0||0.007|2-Sided|95.0|3.9|24.2|||Regression, Logistic||||
1729894|NCT00555360|3186387|Superiority or Other||Mean Difference (Final Values)|-1.87|Standard Deviation|1.7||0.349|2-Sided|95.0|-5.78|2.05|||Regression, Logistic||||
1729895|NCT00555360|3186388|Superiority or Other||Mean Difference (Final Values)|0.74|Standard Deviation|2.0||0.975|2-Sided|95.0|-4.62|4.77|||Regression, Logistic||||
1729896|NCT00555321|3186397|Superiority or Other||Mean Difference (Final Values)|-23.9|||||2-Sided|95.0|-41.8|-4.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729897|NCT00555321|3186397|Superiority or Other||Mean Difference (Final Values)|-22.2|||||2-Sided|95.0|-40.5|-1.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729898|NCT00555321|3186397|Superiority or Other||Mean Difference (Final Values)|-2.4|||||2-Sided|95.0|-24.5|21.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12.|
1729899|NCT00555321|3186397|Superiority or Other||Mean Difference (Final Values)|-9.8|||||2-Sided|95.0|-26.3|7.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729900|NCT00555321|3186397|Superiority or Other||Mean Difference (Final Values)|-8.1|||||2-Sided|95.0|-25.2|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1734621|NCT00509392|3193649|Superiority or Other|||||||0.0048|||||||t-test, 2 sided||||
1729901|NCT00555321|3186397|Superiority or Other||Mean Difference (Final Values)|11.8|||||2-Sided|95.0|-8.7|34.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729902|NCT00555321|3186397|Superiority or Other||Mean Difference (Final Values)|-21.2|||||2-Sided|95.0|-39.1|-1.8|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729903|NCT00555321|3186397|Superiority or Other||Mean Difference (Final Values)|-19.5|||||2-Sided|95.0|-38.6|-0.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729904|NCT00555321|3186397|Superiority or Other||Mean Difference (Final Values)|0.3|||||2-Sided|95.0|-22.0|23.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729905|NCT00555321|3186397|Superiority or Other||Mean Difference (Final Values)|-7.2|||||2-Sided|95.0|-23.4|10.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729906|NCT00555321|3186397|Superiority or Other||Mean Difference (Final Values)|-5.4|||||2-Sided|95.0|-23.4|10.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729907|NCT00555321|3186397|Superiority or Other||Mean Difference (Final Values)|14.4|||||2-Sided|95.0|-6.3|36.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729908|NCT00555321|3186404|Superiority or Other||Mean Difference (Final Values)|-10.8|||||2-Sided|95.0|-29.3|7.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729909|NCT00555321|3186404|Superiority or Other||Mean Difference (Final Values)|-1.3|||||2-Sided|95.0|-19.4|16.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729910|NCT00555321|3186404|Superiority or Other||Mean Difference (Final Values)|2.0|||||2-Sided|95.0|-15.5|19.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729911|NCT00555321|3186404|Superiority or Other||Mean Difference (Final Values)|-20.1|||||2-Sided|95.0|-37.5|-2.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729912|NCT00555321|3186404|Superiority or Other||Mean Difference (Final Values)|-10.5|||||2-Sided|95.0|-27.4|6.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729913|NCT00555321|3186404|Superiority or Other||Mean Difference (Final Values)|-7.2|||||2-Sided|95.0|-23.3|9.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729914|NCT00555321|3186404|Superiority or Other||Mean Difference (Final Values)|-0.6|||||2-Sided|95.0|-18.5|17.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729915|NCT00555321|3186404|Superiority or Other||Mean Difference (Final Values)|7.1|||||2-Sided|95.0|-10.5|24.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729916|NCT00555321|3186404|Superiority or Other||Mean Difference (Final Values)|-6.0|||||2-Sided|95.0|-24.0|12.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729917|NCT00555321|3186404|Superiority or Other||Mean Difference (Final Values)|-2.3|||||2-Sided|95.0|-20.1|15.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729918|NCT00555321|3186404|Superiority or Other||Mean Difference (Final Values)|5.4|||||2-Sided|95.0|-11.7|22.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729919|NCT00555321|3186404|Superiority or Other||Mean Difference (Final Values)|-7.7|||||2-Sided|95.0|-25.6|10.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729920|NCT00555321|3186405|Superiority or Other||Mean Difference (Final Values)|-6.3|||||2-Sided|95.0|-12.7|3.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729921|NCT00555321|3186405|Superiority or Other||Mean Difference (Final Values)|-6.7|||||2-Sided|95.0|-15.6|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729922|NCT00555321|3186405|Superiority or Other||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729923|NCT00555321|3186405|Superiority or Other||Mean Difference (Final Values)|-6.3|||||2-Sided|95.0|-14.9|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729924|NCT00555321|3186405|Superiority or Other||Mean Difference (Final Values)|-6.7|||||2-Sided|95.0|-18.2|5.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729925|NCT00555321|3186405|Superiority or Other||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729926|NCT00555321|3186405|Superiority or Other||Mean Difference (Final Values)|-6.3|||||2-Sided|95.0|-12.7|3.9|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729927|NCT00555321|3186405|Superiority or Other||Mean Difference (Final Values)|-6.7|||||2-Sided|95.0|-15.6|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729928|NCT00555321|3186405|Superiority or Other||Mean Difference (Final Values)|-5.9|||||2-Sided|95.0|-25.1|7.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729929|NCT00555321|3186405|Superiority or Other||Mean Difference (Final Values)|-6.3|||||2-Sided|95.0|-14.9|4.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729930|NCT00555321|3186405|Superiority or Other||Mean Difference (Final Values)|-6.7|||||2-Sided|95.0|-18.2|5.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729931|NCT00555321|3186405|Superiority or Other||Mean Difference (Final Values)|-5.9|||||2-Sided|95.0|-21.2|6.0|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729932|NCT00555321|3186418|Superiority or Other||Mean Difference (Final Values)|-50.5|||||2-Sided|95.0|-81.9|-3.5|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock|
1729933|NCT00555321|3186418|Superiority or Other||Mean Difference (Final Values)|-22.7|||||2-Sided|95.0|-55.9|16.9|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock|
1729934|NCT00555321|3186418|Superiority or Other||Mean Difference (Final Values)|-6.1|||||2-Sided|95.0|-41.1|31.1|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock|
1729935|NCT00555321|3186418|Superiority or Other||Mean Difference (Final Values)|-42.5|||||2-Sided|95.0|-72.6|0.5|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock|
1729936|NCT00555321|3186418|Superiority or Other||Mean Difference (Final Values)|-14.7|||||2-Sided|95.0|-47.4|20.6|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock|
1729937|NCT00555321|3186418|Superiority or Other||Mean Difference (Final Values)|2.0|||||2-Sided|95.0|-32.6|34.3|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method was used.|Analysis at database lock|
1729938|NCT00555321|3186418|Superiority or Other||Mean Difference (Final Values)|-72.7|||||2-Sided|95.0|-94.0|-33.1|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12|
1729939|NCT00555321|3186418|Superiority or Other||Mean Difference (Final Values)|-31.1|||||2-Sided|95.0|-62.6|9.4|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12|
1729940|NCT00555321|3186418|Superiority or Other||Mean Difference (Final Values)|-22.7|||||2-Sided|95.0|-55.9|16.9|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12|
1729941|NCT00555321|3186418|Superiority or Other||Mean Difference (Final Values)|-58.8|||||2-Sided|95.0|-81.6|-19.8|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12|
1729942|NCT00555321|3186418|Superiority or Other||Mean Difference (Final Values)|-17.2|||||2-Sided|95.0|-49.2|19.0|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12|
1729943|NCT00555321|3186418|Superiority or Other||Mean Difference (Final Values)|-8.8|||||2-Sided|95.0|-42.4|26.3|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method was used.|Analysis at Month 12|
1729944|NCT00555321|3186419|Superiority or Other||Mean Difference (Final Values)|-8.9|||||2-Sided|95.0|-34.8|18.7|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729945|NCT00555321|3186419|Superiority or Other||Mean Difference (Final Values)|-7.1|||||2-Sided|95.0|-32.9|19.8|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729946|NCT00555321|3186419|Superiority or Other||Mean Difference (Final Values)|23.4|||||2-Sided|95.0|-5.2|48.4|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729973|NCT00555321|3186445|Superiority or Other||Mean Difference (Final Values)|1.2|||||2-Sided|95.0|-14.5|15.3|||||For 95% CI of difference, normal approximation was used if N>=5 in both arms. Otherwise exact method was used.||
1729947|NCT00555321|3186419|Superiority or Other||Mean Difference (Final Values)|-23.4|||||2-Sided|95.0|-48.2|5.2|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729948|NCT00555321|3186419|Superiority or Other||Mean Difference (Final Values)|-21.6|||||2-Sided|95.0|-46.3|6.3|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729949|NCT00555321|3186419|Superiority or Other||Mean Difference (Final Values)|8.9|||||2-Sided|95.0|-18.8|35.1|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729950|NCT00555321|3186419|Superiority or Other||Mean Difference (Final Values)|-9.5|||||2-Sided|95.0|-34.6|17.3|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729951|NCT00555321|3186419|Superiority or Other||Mean Difference (Final Values)|-11.6|||||2-Sided|95.0|-36.0|14.2|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729952|NCT00555321|3186419|Superiority or Other||Mean Difference (Final Values)|5.8|||||2-Sided|95.0|-21.2|32.1|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729953|NCT00555321|3186419|Superiority or Other||Mean Difference (Final Values)|3.8|||||2-Sided|95.0|-20.1|28.7|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729954|NCT00555321|3186419|Superiority or Other||Mean Difference (Final Values)|1.7|||||2-Sided|95.0|-21.6|25.5|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729955|NCT00555321|3186419|Superiority or Other||Mean Difference (Final Values)|19.1|||||2-Sided|95.0|-6.7|43.3|||||For 95% CI of difference, normal approximation was used if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729956|NCT00555321|3186443|Superiority or Other||Mean Difference (Final Values)|1.9|||||2-Sided|95.0|-21.8|26.0|||||For 95% CI of difference, normal approximation was used if N>=5 in both arms. Otherwise exact method was used.||
1729957|NCT00555321|3186443|Superiority or Other||Mean Difference (Final Values)|14.0|||||2-Sided|95.0|-10.9|37.3|||||For 95% CI of difference, normal approximation was used if N>=5 in both arms. Otherwise exact method was used.||
1729958|NCT00555321|3186443|Superiority or Other||Mean Difference (Final Values)|13.6|||||2-Sided|95.0|-10.8|36.1|||||For 95% CI of difference, normal approximation was used if N>=5 in both arms. Otherwise exact method was used.||
1729959|NCT00555321|3186443|Superiority or Other||Mean Difference (Final Values)|3.9|||||2-Sided|95.0|-16.6|26.8|||||For 95% CI of difference, normal approximation was used if N>=5 in both arms. Otherwise exact method was used.||
1729960|NCT00555321|3186443|Superiority or Other||Mean Difference (Final Values)|16.0|||||2-Sided|95.0|-6.0|38.0|||||For 95% CI of difference, normal approximation was used if N>=5 in both arms. Otherwise exact method was used.||
1729961|NCT00555321|3186443|Superiority or Other||Mean Difference (Final Values)|15.6|||||2-Sided|95.0|-5.8|36.8|||||For 95% CI of difference, normal approximation was used if N>=5 in both arms. Otherwise exact method was used.||
1729962|NCT00555321|3186444|Superiority or Other||Mean Difference (Final Values)|13.1|||||2-Sided|95.0|-5.9|32.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.||
1729963|NCT00555321|3186444|Superiority or Other||Mean Difference (Final Values)|7.9|||||2-Sided|95.0|-11.5|27.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.||
1729964|NCT00555321|3186444|Superiority or Other||Mean Difference (Final Values)|12.0|||||2-Sided|95.0|-7.1|31.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.||
1729965|NCT00555321|3186444|Superiority or Other||Mean Difference (Final Values)|34.2|||||2-Sided|95.0|16.9|51.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.||
1729966|NCT00555321|3186444|Superiority or Other||Mean Difference (Final Values)|29.0|||||2-Sided|95.0|11.4|46.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.||
1729967|NCT00555321|3186444|Superiority or Other||Mean Difference (Final Values)|33.1|||||2-Sided|95.0|15.8|50.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.||
1729968|NCT00555321|3186445|Superiority or Other||Mean Difference (Final Values)|-0.3|||||2-Sided|95.0|-16.9|15.3|||||For 95% CI of difference, normal approximation was used if N>=5 in both arms. Otherwise exact method was used.||
1729969|NCT00555321|3186445|Superiority or Other||Mean Difference (Final Values)|-11.0|||||2-Sided|95.0|-29.4|6.2|||||For 95% CI of difference, normal approximation was used if N>=5 in both arms. Otherwise exact method was used.||
1729970|NCT00555321|3186445|Superiority or Other||Mean Difference (Final Values)|-2.8|||||2-Sided|95.0|-18.1|13.1|||||For 95% CI of difference, normal approximation was used if N>=5 in both arms. Otherwise exact method was used.||
1729971|NCT00555321|3186445|Superiority or Other||Mean Difference (Final Values)|3.7|||||2-Sided|95.0|-13.2|17.5|||||For 95% CI of difference, normal approximation was used if N>=5 in both arms. Otherwise exact method was used.||
1729972|NCT00555321|3186445|Superiority or Other||Mean Difference (Final Values)|-6.9|||||2-Sided|95.0|-25.7|8.8|||||For 95% CI of difference, normal approximation was used if N>=5 in both arms. Otherwise exact method was used.||
1730000|NCT00554515|3186517|Superiority|||||||0.19|||||||Fisher Exact|||Objective response rates were compared between CA-9 score subgroups|
1729974|NCT00555321|3186446|Superiority or Other||Mean Difference (Final Values)|-20.7|||||2-Sided|95.0|-35.5|-4.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729975|NCT00555321|3186446|Superiority or Other||Mean Difference (Final Values)|-4.7|||||2-Sided|95.0|-15.5|10.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729976|NCT00555321|3186446|Superiority or Other||Mean Difference (Final Values)|2.0|||||2-Sided|95.0|-9.9|14.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729977|NCT00555321|3186446|Superiority or Other||Mean Difference (Final Values)|-25.1|||||2-Sided|95.0|-38.9|-9.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729978|NCT00555321|3186446|Superiority or Other||Mean Difference (Final Values)|-9.1|||||2-Sided|95.0|-18.1|5.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729979|NCT00555321|3186446|Superiority or Other||Mean Difference (Final Values)|-2.5|||||2-Sided|95.0|-12.9|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 12|
1729980|NCT00555321|3186446|Superiority or Other||Mean Difference (Final Values)|-12.4|||||2-Sided|95.0|-22.9|4.1|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729981|NCT00555321|3186446|Superiority or Other||Mean Difference (Final Values)|-0.4|||||2-Sided|95.0|-12.1|11.3|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729982|NCT00555321|3186446|Superiority or Other||Mean Difference (Final Values)|0.0||||||95.0|||||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729983|NCT00555321|3186446|Superiority or Other||Mean Difference (Final Values)|-14.9|||||2-Sided|95.0|-23.8|1.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729984|NCT00555321|3186446|Superiority or Other||Mean Difference (Final Values)|-2.9|||||2-Sided|95.0|-13.6|8.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729985|NCT00555321|3186446|Superiority or Other||Mean Difference (Final Values)|-2.5|||||2-Sided|95.0|-12.9|8.7|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.|Analysis at Month 6|
1729986|NCT00555321|3186447|Superiority or Other||Mean Difference (Final Values)|8.9|||||2-Sided|95.0|-9.8|28.4|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.||
1729987|NCT00555321|3186447|Superiority or Other||Mean Difference (Final Values)|3.7|||||2-Sided|95.0|-15.3|23.2|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.||
1729988|NCT00555321|3186447|Superiority or Other||Mean Difference (Final Values)|10.0|||||2-Sided|95.0|-8.7|29.6|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.||
1729989|NCT00555321|3186447|Superiority or Other||Mean Difference (Final Values)|31.8|||||2-Sided|95.0|14.8|48.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.||
1729990|NCT00555321|3186447|Superiority or Other||Mean Difference (Final Values)|26.6|||||2-Sided|95.0|9.6|43.5|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.||
1729991|NCT00555321|3186447|Superiority or Other||Mean Difference (Final Values)|32.9|||||2-Sided|95.0|16.1|49.8|||||For 95% CI of difference, adjustment was made for randomization strata (HCV-Infection status at baseline) if N >= 5 in each treatment arm. Otherwise exact method ignoring stratification was used.||
1729992|NCT00555217|3186448|Superiority or Other||Hazard Ratio (HR)|0.78||||0.1|2-Sided|95.0|0.58|1.05|||Log Rank||Combination ARB and ACEI vs. mono therapy ARB||
1729993|NCT00555217|3186449|Superiority or Other||Cox Proportional Hazard|0.88||||0.3|2-Sided|95.0|0.7|1.12|||Log Rank||Combination ARB and ACEI vs. mono therapy ARB||
1729994|NCT00555152|3186452|Superiority or Other|||||||1|||||||Fisher Exact||||
1729995|NCT00554853|3186481|Superiority or Other|||||||0.63|||||||ANCOVA||||
1729996|NCT00554749|3186495|Superiority or Other||Mean Difference (Net)|2.09|Standard Deviation|0.43|<|0.001||95.0|1.69|2.49|||paired t-test|Paired t-test of SSQ at baseline vs at 6 months, degrees of freedom=6. Difference in SSQ is reported.|||
1729997|NCT00554515|3186514|Superiority|||||||0.28|||||||Fisher Exact|||Objective response rates were compared between CA-9 SNP subgroups|
1729998|NCT00554515|3186515|Superiority|||||||0.08|||||||Fisher Exact|||Objective response rates were compared between B7-H3 tumor subgroups|
1729999|NCT00554515|3186516|Superiority|||||||0.01|||||||Fisher Exact|||Objective response rates were compared between PD-L1 tumor subgroups|
1734622|NCT00509392|3193650|Superiority or Other|||||||0.2962|||||||t-test, 2 sided||||
1730003|NCT00554515|3186521|Superiority|||||||0.89|||||||Fisher Exact|||Objective response rates were compared between MSKCC subgroups.|
1730004|NCT00554515|3186524|Superiority|||||||0.0014|||||||exact binomial test|||Test against the historical ORR was conducted in the overall study population as secondary analyses.|
1730005|NCT00554515|3186525|Superiority|||||||0.39|||||||Fisher Exact|||Objective response rates were compared between ISM good and poor risk subgroups. ISM good risk ORR reported under primary endpoint.|
1730006|NCT00554515|3186526|Superiority|Comparison against historical control ORR of 14%.||||||0.042|||||||exact binomial test||||
1730007|NCT00554294|3186542|Superiority or Other||Odds Ratio (OR)|0.69|||<|0.05||95.0|0.48|0.98|||Regression, Logistic|The Odds Ratio (OR) describes the probability ob beeing overweight of the intervention group compared to the control group (reference, denominator).||adjusted for overweight at baseline, age at baseline,sex and clustering by school|
1730008|NCT00554216|3186553|Superiority or Other||Odds Ratio (OR)|2.42|Standard Error of the Mean|0.394|<|0.0001|2-Sided|95.0|1.76|3.33||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1730009|NCT00554216|3186553|Superiority or Other||Odds Ratio (OR)|3.97|Standard Error of the Mean|0.706|<|0.0001|2-Sided|95.0|2.8|5.63||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1730010|NCT00554216|3186553|Superiority or Other||Odds Ratio (OR)|9.61|Standard Error of the Mean|1.463|<|0.0001|2-Sided|95.0|7.13|12.95||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1730011|NCT00554216|3186554|Superiority or Other||Mean Difference (Final Values)|5.82|Standard Error of the Mean|0.596|<|0.0001|2-Sided|95.0|4.65|6.99||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1730012|NCT00554216|3186554|Superiority or Other||Mean Difference (Final Values)|3.54|Standard Error of the Mean|0.596|<|0.0001|2-Sided|95.0|2.38|4.71||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1730013|NCT00554216|3186554|Superiority or Other||Mean Difference (Final Values)|9.36|Standard Error of the Mean|0.476|<|0.0001|2-Sided|95.0|8.43|10.3||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 250 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1730014|NCT00554099|3186557|Superiority or Other||Difference vs. Mesalamine|8.9|Standard Error of the Mean|12.23||0.7703|1-Sided|90.0||24.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730015|NCT00554099|3186557|Superiority or Other||Difference vs. Placebo|6.0|Standard Error of the Mean|12.66||0.6721|1-Sided|90.0||22.2|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730016|NCT00554099|3186557|Superiority or Other||Difference vs. Placebo|-2.9|Standard Error of the Mean|11.7||0.3983|1-Sided|90.0||12.1|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730017|NCT00554099|3186558|Superiority or Other||Difference vs. Mesalamine|-0.7|Standard Error of the Mean|7.61||0.4613|1-Sided|90.0||9.0|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730018|NCT00554099|3186558|Superiority or Other||Difference vs. Placebo|-8.2|Standard Error of the Mean|8.4||0.173|1-Sided|90.0||2.5|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730019|NCT00554099|3186558|Superiority or Other||Difference vs. Placebo|-7.5|Standard Error of the Mean|8.21||0.1907|1-Sided|90.0||3.0|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730020|NCT00554099|3186559|Superiority or Other||Difference vs. Mesalamine|-5.0|Standard Error of the Mean|3.45||0.1039|1-Sided|90.0||-0.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730021|NCT00554099|3186559|Superiority or Other||Difference vs. Placebo|-2.4|Standard Error of the Mean|2.41||0.1708|1-Sided|90.0||0.6|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730022|NCT00554099|3186559|Superiority or Other||Difference vs. Placebo|2.6|Standard Error of the Mean|4.2||0.7165|1-Sided|90.0||7.9|||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730023|NCT00554099|3186560|Superiority or Other||LS Mean Difference vs. Mesalamine|1.253|Standard Error of the Mean|2.996||0.6615|1-Sided|90.0||5.129|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.|||
1730024|NCT00554099|3186560|Superiority or Other||LS Mean Difference vs. Placebo|0.825|Standard Error of the Mean|3.151||0.6029|1-Sided|90.0||4.903|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.|||
1730025|NCT00554099|3186560|Superiority or Other||LS Mean Difference vs. Placebo|-0.428|Standard Error of the Mean|3.067||0.4448|1-Sided|90.0||3.541|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.|||
1730026|NCT00554099|3186561|Superiority or Other||LS Mean Difference vs. Mesalamine|1.483|Standard Error of the Mean|2.836||0.6988|1-Sided|90.0||5.145|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.|||
1730027|NCT00554099|3186561|Superiority or Other||LS Mean Difference vs. Placebo|0.083|Standard Error of the Mean|2.903||0.5113|1-Sided|90.0||3.832|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.|||
1730028|NCT00554099|3186561|Superiority or Other||LS Mean Difference vs. Placebo|-1.4|Standard Error of the Mean|2.784||0.3082|1-Sided|90.0||2.196|||ANOVA|Fixed effects for treatment and number of diverticulitis attacks.|||
1730029|NCT00554099|3186562|Superiority or Other||Difference vs. Placebo|-37.5|Standard Error of the Mean|12.98||0.9962|1-Sided|90.0|-54.1||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730030|NCT00554099|3186562|Superiority or Other||Difference vs. Placebo|-20.8|Standard Error of the Mean|14.13||0.9288|1-Sided|90.0|-38.9||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730031|NCT00554099|3186562|Superiority or Other||Difference vs. Placebo|16.7|Standard Error of the Mean|14.0||0.1266|1-Sided|90.0|-1.3||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730032|NCT00554099|3186563|Superiority or Other||Difference vs. Mesalamine|-14.4|Standard Error of the Mean|12.87||0.8596|1-Sided|90.0|-30.8||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730033|NCT00554099|3186563|Superiority or Other||Difference vs. Placebo|6.8|Standard Error of the Mean|13.27||0.3248|1-Sided|90.0|-10.2||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730034|NCT00554099|3186563|Superiority or Other||Difference vs. Placebo|21.1|Standard Error of the Mean|12.53||0.0576|1-Sided|90.0|5.1||||Cochran-Mantel-Haenszel|Stratified by number of diverticulitis attacks.|||
1730035|NCT00554099|3186564|Superiority or Other||Mean Difference vs. Asacol|1.6|Standard Error of the Mean|1.58||0.4365|1-Sided|90.0||3.573|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.|
1730036|NCT00554099|3186564|Superiority or Other||Mean Difference vs. Placebo|-1.4|Standard Error of the Mean|1.74||0.6285|1-Sided|90.0||0.815|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.|
1730037|NCT00554099|3186564|Superiority or Other||Mean Difference vs. Placebo|-3.0|Standard Error of the Mean|1.69||0.3781|1-Sided|90.0||-0.809|||ANCOVA|Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.||It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.|
1730038|NCT00553787|3186569|Superiority or Other||Odds Ratio (OR)|1.44|Standard Error of the Mean|0.169||0.0018|2-Sided|95.0|1.15|1.81||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1730039|NCT00553787|3186569|Superiority or Other||Odds Ratio (OR)|6.27|Standard Error of the Mean|0.768|<|0.0001|2-Sided|95.0|4.93|7.97||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1730040|NCT00553787|3186569|Superiority or Other||Odds Ratio (OR)|9.03|Standard Error of the Mean|0.955|<|0.0001|2-Sided|95.0|7.34|11.11||Intersection-union method applied in a step-down testing approach|Regression, Logistic|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1730041|NCT00553787|3186570|Superiority or Other||Mean Difference (Final Values)|2.03|Standard Error of the Mean|0.402|<|0.0001|2-Sided|95.0|1.24|2.82||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1730042|NCT00553787|3186570|Superiority or Other||Mean Difference (Final Values)|6.58|Standard Error of the Mean|0.403|<|0.0001|2-Sided|95.0|5.79|7.37||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1730043|NCT00553787|3186570|Superiority or Other||Mean Difference (Final Values)|8.6|Standard Error of the Mean|0.328|<|0.0001|2-Sided|95.0|7.96|9.25||Intersection-union method applied in a step-down testing approach|ANCOVA|||With at least 500 subjects in each of the 3 arms in this trial, the trial has more than 90% power to detect a difference of at least 3.1% between combination and placebo treatment assuming a standard deviation of 5.3% and a significance level of 0.05.|
1730044|NCT00553605|3186605|Superiority or Other|||||||0.9645|||||||Log Rank||||
1730045|NCT00553605|3186606|Superiority or Other|||||||0.6847|||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.|
1730046|NCT00553605|3186606|Superiority or Other|||||||0.9783|||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.|
1730047|NCT00553605|3186607|Superiority or Other|||||||0.7659|||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using CMH model and using modified ridit scores, testing for non-zero correlation and controlling for country.|
1730048|NCT00553605|3186607|Superiority or Other|||||||0.2482|||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.|
1730171|NCT00552513|3186767|Superiority or Other||Hazard Ratio (HR)|0.85||||0.15|2-Sided|95.0|0.68|1.06|||Regression, Logistic||||
1730049|NCT00553605|3186608|Superiority or Other||Odds Ratio (OR)|1.007||||0.9785|2-Sided|95.0|0.6|1.69|||Regression, Logistic|||p-value was based on logistic regression model with terms for treatment group and baseline as covariates.|
1730050|NCT00553605|3186609|Superiority or Other|||||||0.5552|||||||Cochran-Mantel-Haenszel|||Minute 120: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.|
1730051|NCT00553605|3186609|Superiority or Other|||||||0.3982|||||||Cochran-Mantel-Haenszel|||Minute 30: p-value was calculated using Cochran-Mantel-Haenszel (CMH) model and using modified ridit scores, testing for non-zero correlation and controlling for country.|
1730052|NCT00553605|3186610|Superiority or Other||LS mean difference|10.13|Standard Error of the Mean|13.43||0.451|2-Sided|95.0|-16.3|36.54|||ANCOVA|||p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country as covariates.|
1730053|NCT00553605|3186611|Superiority or Other||LS mean difference|0.16|Standard Error of the Mean|1.72||0.926|2-Sided|95.0|-3.23|3.55|||ANCOVA|||Minute 120: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.|
1730054|NCT00553605|3186611|Superiority or Other||LS mean difference|2.16|Standard Error of the Mean|2.14||0.314|2-Sided|95.0|-2.05|6.37|||ANCOVA|||Minute 90: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.|
1730055|NCT00553605|3186611|Superiority or Other||LS mean difference|2.62|Standard Error of the Mean|2.47||0.29|2-Sided|95.0|-2.24|7.48|||ANCOVA|||Minute 60: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.|
1730056|NCT00553605|3186611|Superiority or Other||LS mean difference|0.94|Standard Error of the Mean|2.7||0.729|2-Sided|95.0|-4.38|6.26|||ANCOVA|||Minute 45: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.|
1730057|NCT00553605|3186611|Superiority or Other||LS mean difference|-0.49|Standard Error of the Mean|2.91||0.866|2-Sided|95.0|-6.22|5.24|||ANCOVA|||Minute 30: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.|
1730058|NCT00553605|3186611|Superiority or Other||LS mean difference|0.75|Standard Error of the Mean|2.56||0.768|2-Sided|95.0|-4.28|5.79|||ANCOVA|||Minute 15: p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.|
1730059|NCT00553605|3186613|Superiority or Other||LS mean difference|-0.09|Standard Error of the Mean|2.52||0.972|2-Sided|95.0|-5.04|4.86|||ANCOVA|||p-value, LS mean difference and 95% CI were based on ANCOVA model with terms for treatment group and country, and baseline as covariates.|
1730060|NCT00553605|3186614|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower bound of the 2-sided 95% CI of the treatment difference (parecoxib - ketoprofen) was greater than -10 mm.|Least-squares (LS) mean difference|-1.12|Standard Error of the Mean|2.75|||2-Sided|95.0|-6.53|4.3||||||LS mean difference and 95 percent (%) confidence interval (CI) were based on analysis of covariance (ANCOVA) model with terms for treatment group and country, and baseline as covariates.|
1730061|NCT00553475|3186625|Superiority or Other||Mean Difference (Final Values)|-0.74||||0.0152||95.0|-1.34|-0.14|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730062|NCT00553475|3186625|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.0013||95.0|-1.07|-0.26|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730063|NCT00553475|3186626|Superiority or Other|||||||0.0075|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730064|NCT00553475|3186626|Superiority or Other|||||||0.0818|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730065|NCT00553475|3186627|Superiority or Other|||||||0.0063|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730066|NCT00553475|3186627|Superiority or Other|||||||0.0148|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel chi-squared with a modified ridit transformation, stratified by stratum based on the CLcr||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730067|NCT00553475|3186628|Superiority or Other||Mean Difference (Final Values)|-1.82||||0.4183||95.0|-6.24|2.6|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730068|NCT00553475|3186628|Superiority or Other||Mean Difference (Final Values)|-3.54||||0.0269||95.0|-6.67|-0.41|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730069|NCT00553475|3186629|Superiority or Other||Mean Difference (Final Values)|7.79||||0.0206||95.0|1.2|14.38|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730070|NCT00553475|3186629|Superiority or Other||Mean Difference (Final Values)|3.79||||0.1123||95.0|-0.89|8.47|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730071|NCT00553475|3186630|Superiority or Other||Mean Difference (Final Values)|9.65||||0.0173||95.0|1.72|17.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1734623|NCT00509392|3193651|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1730072|NCT00553475|3186630|Superiority or Other||Mean Difference (Final Values)|5.62||||0.0511||95.0|-0.03|11.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730073|NCT00553475|3186631|Superiority or Other||Mean Difference (Final Values)|0.17||||0.3661||95.0|-0.2|0.55|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730074|NCT00553475|3186631|Superiority or Other||Mean Difference (Final Values)|0.32||||0.0177||95.0|0.06|0.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730075|NCT00553475|3186632|Superiority or Other||Mean Difference (Final Values)|-2.84||||0.2782||95.0|-7.97|2.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730076|NCT00553475|3186632|Superiority or Other||Mean Difference (Final Values)|-1.39||||0.4538||95.0|-5.05|2.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730077|NCT00553475|3186633|Superiority or Other||Mean Difference (Final Values)|4.44||||0.2532||95.0|-3.19|12.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730078|NCT00553475|3186633|Superiority or Other||Mean Difference (Final Values)|0.03||||0.9905||95.0|-5.37|5.43|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730079|NCT00553475|3186634|Superiority or Other||Mean Difference (Final Values)|-3.78||||0.1907||95.0|-9.45|1.89|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730080|NCT00553475|3186634|Superiority or Other||Mean Difference (Final Values)|-6.37||||0.0019||95.0|-10.38|-2.36|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730081|NCT00553475|3186635|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.0073||95.0|-0.65|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730082|NCT00553475|3186635|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.0365||95.0|-0.4|-0.01|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730083|NCT00553475|3186636|Superiority or Other||Mean Difference (Final Values)|-7.49||||0.0427||95.0|-14.74|-0.25|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730084|NCT00553475|3186636|Superiority or Other||Mean Difference (Final Values)|-7.27||||0.0056||95.0|-12.4|-2.14|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730085|NCT00553475|3186637|Superiority or Other||Mean Difference (Final Values)|-2.67||||0.0087||95.0|-4.67|-0.68|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730086|NCT00553475|3186637|Superiority or Other||Mean Difference (Final Values)|-2.35||||0.0013||95.0|-3.76|-0.93|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730087|NCT00553475|3186638|Superiority or Other||Mean Difference (Final Values)|-0.56||||0.0707||95.0|-1.17|0.05|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730088|NCT00553475|3186638|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.0068||95.0|-1.03|-0.17|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730089|NCT00553475|3186639|Superiority or Other||Mean Difference (Final Values)|-2.13||||0.0062||95.0|-3.65|-0.61|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730090|NCT00553475|3186639|Superiority or Other||Mean Difference (Final Values)|-1.79||||0.0013||95.0|-2.87|-0.71|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730091|NCT00553475|3186640|Superiority or Other||Mean Difference (Final Values)|-0.63||||0.0273||95.0|-1.19|-0.07|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730092|NCT00553475|3186640|Superiority or Other||Mean Difference (Final Values)|-0.85|||<|0.0001||95.0|-1.25|-0.46|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730093|NCT00553475|3186641|Superiority or Other||Mean Difference (Final Values)|3.97||||0.1625||95.0|-1.61|9.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730094|NCT00553475|3186641|Superiority or Other||Mean Difference (Final Values)|1.49||||0.4602||95.0|-2.47|5.45|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730137|NCT00553475|3186663|Superiority or Other||Mean Difference (Final Values)|-0.74||||0.0254||95.0|-1.39|-0.09|||ANCOVA|Treatment groups and the CLcr strata as factors and baseline values as covariates.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730095|NCT00553475|3186642|Superiority or Other||Mean Difference (Final Values)|7.59||||0.0109||95.0|1.76|13.42|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730096|NCT00553475|3186642|Superiority or Other||Mean Difference (Final Values)|-1.07||||0.6118||95.0|-5.23|3.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730097|NCT00553475|3186643|Superiority or Other||Mean Difference (Final Values)|-0.77||||0.0111||95.0|-1.37|-0.18|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730098|NCT00553475|3186643|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.0016||95.0|-1.05|-0.25|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730099|NCT00553475|3186644|Superiority or Other||Mean Difference (Final Values)|-0.77||||0.0105||95.0|-1.36|-0.18|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730100|NCT00553475|3186644|Superiority or Other||Mean Difference (Final Values)|-0.62||||0.0023||95.0|-1.02|-0.22|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730101|NCT00553475|3186645|Superiority or Other||Mean Difference (Final Values)|-0.87||||0.0034||95.0|-1.46|-0.29|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730102|NCT00553475|3186645|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.0005||95.0|-1.1|-0.31|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730103|NCT00553475|3186646|Superiority or Other||Mean Difference (Final Values)|-0.86||||0.0036||95.0|-1.44|-0.28|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730104|NCT00553475|3186646|Superiority or Other||Mean Difference (Final Values)|-0.73||||0.0003||95.0|-1.12|-0.33|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730105|NCT00553475|3186647|Superiority or Other||Mean Difference (Final Values)|-0.94||||0.0014||95.0|-1.51|-0.36|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730106|NCT00553475|3186647|Superiority or Other||Mean Difference (Final Values)|-0.67||||0.0008||95.0|-1.07|-0.28|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730107|NCT00553475|3186648|Superiority or Other||Mean Difference (Final Values)|-1.09||||0.0002||95.0|-1.66|-0.52|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730108|NCT00553475|3186648|Superiority or Other||Mean Difference (Final Values)|-0.72||||0.0003||95.0|-1.12|-0.33|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730109|NCT00553475|3186649|Superiority or Other||Mean Difference (Final Values)|-1.12|||<|0.0001||95.0|-1.68|-0.56|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730110|NCT00553475|3186649|Superiority or Other||Mean Difference (Final Values)|-0.79|||<|0.0001||95.0|-1.18|-0.4|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730111|NCT00553475|3186650|Superiority or Other||Mean Difference (Final Values)|-1.16|||<|0.0001||95.0|-1.72|-0.6|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730112|NCT00553475|3186650|Superiority or Other||Mean Difference (Final Values)|-0.65|||<|0.0011||95.0|-1.04|-0.26|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730113|NCT00553475|3186651|Superiority or Other||Mean Difference (Final Values)|-1.11|||<|0.0001||95.0|-1.67|-0.56|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1734624|NCT00509392|3193652|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1730114|NCT00553475|3186651|Superiority or Other||Mean Difference (Final Values)|-0.64|||<|0.0012||95.0|-1.03|-0.25|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730115|NCT00553475|3186652|Superiority or Other||Mean Difference (Final Values)|-1.13|||<|0.0001||95.0|-1.69|-0.58|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730116|NCT00553475|3186652|Superiority or Other||Mean Difference (Final Values)|-0.6|||<|0.0026||95.0|-0.99|-0.21|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730117|NCT00553475|3186653|Superiority or Other||Mean Difference (Final Values)|-1.23|||<|0.0001||95.0|-1.78|-0.69|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730118|NCT00553475|3186653|Superiority or Other||Mean Difference (Final Values)|-0.61|||<|0.0021||95.0|-1.0|-0.22|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730119|NCT00553475|3186654|Superiority or Other||Median Difference (Final Values)|-0.75||||0.0073||95.0|-1.29|-0.2|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730120|NCT00553475|3186654|Superiority or Other||Mean Difference (Final Values)|-0.43||||0.0287||95.0|-0.82|-0.05|||Mixed Model Repeated Measures Analysis|Model included treatment, CLcr stratum, week and treatment-by-week interaction, and baseline scores as fixed effects, and subject as a random effect.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730121|NCT00553475|3186655|Superiority or Other|||||||0.059|||||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Significance level of 0.05 was used.|
1730122|NCT00553475|3186655|Superiority or Other|||||||0.153|||||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Significance level of 0.05 was used.|
1730123|NCT00553475|3186656|Superiority or Other||Mean Difference (Final Values)|-0.64||||0.0333||95.0|-1.23|-0.05|||ANCOVA|Treatment groups as factors and baseline values as covariates||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730124|NCT00553475|3186656|Superiority or Other||Mean Difference (Final Values)|-0.67||||0.0058||95.0|-1.14|-0.19|||ANCOVA|Treatment groups as factors and baseline values as covariates||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730125|NCT00553475|3186657|Superiority or Other||Mean Difference (Final Values)|2.22||||0.5712||95.0|-5.49|9.93|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730126|NCT00553475|3186657|Superiority or Other||Mean Difference (Final Values)|0.92||||0.7394||95.0|-4.52|6.37|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730127|NCT00553475|3186658|Superiority or Other||Mean Difference (Final Values)|8.15||||0.0278||95.0|0.89|15.42|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730128|NCT00553475|3186658|Superiority or Other||Mean Difference (Final Values)|5.06||||0.0544||95.0|-0.1|10.21|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730129|NCT00553475|3186659|Superiority or Other||Mean Difference (Final Values)|2.09||||0.348||95.0|-2.29|6.47|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730130|NCT00553475|3186659|Superiority or Other||Mean Difference (Final Values)|0.98||||0.5372||95.0|-2.13|4.09|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730131|NCT00553475|3186660|Superiority or Other||Mean Difference (Final Values)|2.56||||0.4008||95.0|-3.42|8.53|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730132|NCT00553475|3186660|Superiority or Other||Mean Difference (Final Values)|1.5||||0.4873||95.0|-2.75|5.76|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730133|NCT00553475|3186661|Superiority or Other||Mean Difference (Final Values)|-0.41||||0.9153||95.0|-7.96|7.14|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730134|NCT00553475|3186661|Superiority or Other||Mean Difference (Final Values)|-2.1||||0.4398||95.0|-7.44|3.24|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730135|NCT00553475|3186662|Superiority or Other||Mean Difference (Final Values)|1.16||||0.6337||95.0|-3.62|5.94|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730136|NCT00553475|3186662|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.8731||95.0|-3.67|3.12|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730138|NCT00553475|3186663|Superiority or Other||Mean Difference (Final Values)|-0.63||||0.0075||95.0|-1.09|-0.17|||ANCOVA|Treatment groups and the CLcr strata as factors and baseline values as covariates.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1730139|NCT00553410|3186670|Superiority||Hazard Ratio (HR)|0.98||||0.84|2-Sided|95.0|0.81|1.18|||Log Rank||||
1730140|NCT00553410|3186671|Superiority||Hazard Ratio (HR)|0.88||||0.25|2-Sided|95.0|0.71|1.09|||Log Rank||||
1730141|NCT00553410|3186672|Superiority||Hazard Ratio (HR)|0.85||||0.16|2-Sided|95.0|0.68|1.06|||Log Rank||||
1730142|NCT00553410|3186673|Superiority||Hazard Ratio (HR)|1.08||||0.31|2-Sided|95.0|0.93|1.26|||Log Rank||||
1730143|NCT00553358|3186685|Superiority or Other (legacy)||Percentage of participants with pCR|21.79||||0.0001|2-Sided|97.5|9.08|34.23|||Binomial|Binomial p-value for Trastuzumab 2 mg/kg versus Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Estimation Comments: Estimated value is the difference in the percentage of participants with pCR: Arm3 (Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg) minus Arm2 (Trastuzumab 2 mg/kg)||
1730144|NCT00553358|3186685|Superiority or Other (legacy)||Percentage of participants with pCR|-4.85||||0.3416|2-Sided|97.5|-17.6|8.16|||Binomial|Binomial p-value for Trastuzumab 2 mg/kg versus Lapatinib 1500 mg|Estimation Comments: Estimated value is the difference in the percentage of participants with pCR: Arm1 (Lapatinib 1500 mg) minus Arm2 (Trastuzumab 2 mg/kg)||
1730145|NCT00553267|3186702|Superiority or Other||||||<|0.001|||||||Wilcoxon rank sum test|Stratified (for country) Wilcoxon rank sum test|||
1730146|NCT00553267|3186702|Superiority or Other||||||<|0.006|||||||Wilcoxon rank sum test|Stratified (for country) Wilcoxon rank sum test|||
1730147|NCT00553267|3186703|Superiority or Other||Odds Ratio (OR)|1.67||||0.002||95.0|1.2|2.32|||Mantel Haenszel|Mantel−Haenszel statistics adjusted for country effect|||
1730148|NCT00553267|3186703|Superiority or Other||Odds Ratio (OR)|1.58||||0.006||95.0|1.14|2.21|||Mantel Haenszel|Mantel−Haenszel statistics adjusted for country effect|||
1730149|NCT00553267|3186704|Superiority or Other||Odds Ratio (OR)|1.55||||0.008||95.0|1.12|2.15|||Mantel Haenszel|Mantel−Haenszel statistics adjusted for country effect|||
1730150|NCT00553267|3186704|Superiority or Other||Odds Ratio (OR)|1.44||||0.027||95.0|1.04|2.0|||Mantel Haenszel|Mantel−Haenszel statistics adjusted for country effect|||
1730151|NCT00553267|3186705|Superiority or Other||Odds Ratio (OR)|1.92|||<|0.001||95.0|1.38|2.68|||Mantel Haenszel|Mantel−Haenszel statistics adjusted for country effect|||
1730152|NCT00553267|3186705|Superiority or Other||Odds Ratio (OR)|1.68|||<|0.002||95.0|1.21|2.34|||Mantel Haenszel|Mantel−Haenszel statistics adjusted for country effect|||
1730153|NCT00553267|3186706|Superiority or Other||Odds Ratio (OR)|2.33||||0.004||95.0|1.29|4.22|||Mantel Haenszel|Mantel−Haenszel statistics adjusted for country effect|||
1730154|NCT00553267|3186706|Superiority or Other||Odds Ratio (OR)|2.35||||0.004||95.0|1.3|4.25|||Mantel Haenszel|Mantel−Haenszel statistics adjusted for country effect|||
1730155|NCT00553267|3186707|Superiority or Other||Odds Ratio (OR)|1.91|||<|0.001||95.0|1.37|2.65|||Mantel Haenszel|Mantel−Haenszel statistics adjusted for country effect|||
1730156|NCT00553267|3186707|Superiority or Other||Odds Ratio (OR)|1.67|||<|0.002|2-Sided|95.0|1.21|2.32|||Mantel Haenszel|Mantel−Haenszel statistics adjusted for country effect|||
1730157|NCT00553267|3186708|Superiority or Other||Least Squares Mean Difference|-3.85|Standard Error of the Mean|0.76|<|0.0001||95.0|-5.35|-2.36|||ANCOVA|Adjusted for baseline and country effect|||
1730158|NCT00553267|3186708|Superiority or Other||Least Squares Mean Difference|-3.66|Standard Error of the Mean|0.76|<|0.0001||95.0|-5.15|-2.16|||ANCOVA|Adjusted for baseline and country effect|||
1730159|NCT00553267|3186709|Superiority or Other||Least Squares Mean Difference|-2.85|Standard Error of the Mean|0.51|<|0.0001||95.0|-3.86|-1.84||Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.|ANCOVA|Adjusted for baseline and country effect||"Testing that the combination treatments are superior to monotherapy A10.~The number of patients in the treatment arms ensure the tests have over 90% power."|
1730160|NCT00553267|3186709|Superiority or Other||Least Squares Mean Difference|-2.76|Standard Error of the Mean|0.52|<|0.0001||95.0|-3.77|-1.75||Doses tested against A10 in a hierarchical manner to address issues of multiplicity. T80/A10 was tested first, then T40/A10.|ANCOVA|Adjusted for baseline and country effect||"Testing that the combination treatments are superior to monotherapy A10.~The number of patients in the treatment arms ensure the tests have over 90% power."|
1730161|NCT00553150|3186725|Superiority or Other (legacy)||Maximum Tolerated Dose (mg)|70.0|||||2-Sided||||||||||
1730162|NCT00552786|3186744|Superiority or Other||||||<|0.05|||||||ANOVA|Assessing the bioequivalence on temporary threshold shift at 3k,4k,6k Hz between NAC and Placebo was carried out using ANOVA for 2×2 crossover design.|||
1730163|NCT00552786|3186745|Superiority or Other||||||<|0.05||||||Two-sided|ANOVA|Assessing the bioequivalence on temporary threshold shift at3k,4k,6k Hz between NAC and Placebo was carried out using ANOVA for 2×2 crossover design.|||
1730164|NCT00552669|3186753|Superiority or Other||||||<|0.05|||||||Chi-squared|||"power calculation 80% Hypothesis: No significant diferences between Target Vessel Revascularization (TVR) between both groups.~All events will be recorded and an independent blind for groups clinical events committee will adjudicate each one."|
1730165|NCT00552669|3186754|Superiority or Other|||||||0.05|||||||Chi-squared|||Based on our previous data the incidence of relevant clinical events was similar in both groups (ERACI III and ORAR II)|
1730166|NCT00552669|3186755|Superiority or Other||||||<|0.05|||||||ANOVA|||We used One way annalysis of a variance for means and standard deviation.|
1730167|NCT00552578|3186759|Superiority or Other|||||||0.015||||||No adjustment|Fisher Exact|||Fisher exact test was used and tested the hypothesis that neither group would be more likely to complete the study protocol.|
1730168|NCT00552578|3186761|Superiority or Other||Odds Ratio (OR)|0.17||||0.523||95.0|0.0098|2.8215|||Fisher Exact|||Intent to treat|
1730169|NCT00552513|3186765|Superiority or Other||Hazard Ratio (HR)|0.84||||0.04|2-Sided|95.0|0.71|0.99|||Regression, Logistic||||
1730170|NCT00552513|3186766|Superiority or Other||Hazard Ratio (HR)|0.72||||0.003|2-Sided|95.0|0.58|0.89|||Regression, Logistic||||
1730172|NCT00552409|3186773|Superiority or Other||Mean Difference (Final Values)|-17.0|||||2-Sided|95.0|-56.0|251.0|||||Mean urine ACR on treatment was 17% lower among participants assigned to cholecalciferol, compared to participants assigned to placebo, adjusted for baseline values.||
1730173|NCT00552240|3186808|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.4645||95.0|-1.02|0.47|||ANCOVA|Controlling for screening viral load and CD4+ categories|||
1730174|NCT00552240|3186809|Superiority or Other||Mean Difference (Final Values)|-0.33||||0.0375||95.0|-0.64|-0.02|||ANCOVA|Controlling for screening viral load and CD4+ categories|||
1730175|NCT00552240|3186810|Superiority or Other||Mean Difference (Final Values)|0.4||||0.9257||95.0|-8.4|9.3|||ANCOVA|Controlling for screening viral load and CD4+ categories|||
1730176|NCT00552240|3186811|Superiority or Other||Mean Difference (Final Values)|4.8||||0.0164||95.0|0.9|8.8|||ANCOVA|Controlling for screening viral load and CD4+ categories|||
1730177|NCT00552240|3186812|Superiority or Other||Median Difference (Final Values)|-10.6||||0.3625||95.0|-33.4|12.3|||ANCOVA|Controlling for screening viral load and CD4+ categories|||
1730178|NCT00552240|3186813|Superiority or Other||Median Difference (Final Values)|1.8||||0.7315||95.0|-8.4|11.9|||ANCOVA|Controlling for screening viral load and CD4+ categories|||
1730179|NCT00552240|3186841|Superiority or Other||Hazard Ratio (HR)|0.628||||0.0172||95.0|0.428|0.921|||Regression, Cox|Controlling for screening viral load and CD4+ categories||"Responders only~Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values < 1 indicate faster response in nevirapine."|
1730180|NCT00552240|3186842|Superiority or Other||Hazard Ratio (HR)|0.666||||0.0314||95.0|0.46|0.964|||Regression, Cox|Controlling for screening viral load and CD4+ categories.||Hazard ratio Atazanavir plus ritonavir / Nevirapine. Values < 1 indicate faster response in nevirapine.|
1730181|NCT00552240|3186843|Non-Inferiority or Equivalence|Same as for primary analysis|Difference in proportion of responders|-0.067||||0.3703||95.0|-0.215|0.08|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories|||
1730182|NCT00552240|3186844|Non-Inferiority or Equivalence|Same as for primary analysis|Difference in proportion of responders|0.084||||0.1477||95.0|-0.03|0.197|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories|||
1730183|NCT00552240|3186845|Non-Inferiority or Equivalence|Same as for the primary analysis|Difference in proportion of responders|-0.027||||0.6479||95.0|-0.167|0.113|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories|||
1730184|NCT00552240|3186846|Non-Inferiority or Equivalence|A point estimate of -6.5% or higher for the diff. in the prop. of responders (NVP - ATV/r) was to be considered consistent with a successful ArTEN study. In the worst case for both studies, if the 2 studies were to be pooled, the non-inferiority margin of -12% would then be outside the 95% confidence interval (CI).|Difference in proportion of responders|-0.041||||0.7142||95.0|-0.183|0.101|||Cochran-Mantel-Haenszel|Controlling for screening viral load and CD4+ categories||With 75 evaluable patients per treatment group, this study had 80% power to observe a difference no lower than -6.5% assuming the true proportions of responders are both 65%.|
1730185|NCT00552188|3186847|Superiority or Other|||||||0.15|||||||ANCOVA|||ANCOVA model adjusted for baseline|
1730186|NCT00552188|3186848|Superiority or Other|||||||0.34|||||||ANCOVA|||ANCOVA model adjusted for baseline value|
1730187|NCT00552175|3186849|Superiority or Other||Least Squares Mean Difference|-0.55|||||2-Sided|95.0|-1.92|0.81|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730188|NCT00552175|3186849|Superiority or Other||Least Squares Mean Difference|0.34|||||2-Sided|95.0|-1.03|1.71|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730189|NCT00552175|3186850|Superiority or Other||Least Squares Mean Difference|-0.11||||0.8517|2-Sided|95.0|-1.22|1.01|||Mixed Models Analysis|Covariates: Baseline value of BDI-II, type of diabetes, and duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730190|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.52|||||2-Sided|95.0|-0.97|-0.07|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average of Interference scores analysis|
1730191|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.45|||||2-Sided|95.0|-0.9|0.0|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average of Interference scores analysis|
1730192|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.76|||||2-Sided|95.0|-1.27|-0.24|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Enjoyment of Life score analysis|
1730193|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.37|||||2-Sided|95.0|-0.88|0.15|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Enjoyment of Life score analysis|
1730194|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.36|||||2-Sided|95.0|-0.9|0.18|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Sleep score analysis|
1730195|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.57|||||2-Sided|95.0|-1.11|-0.03|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Sleep score analysis|
1730196|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.71|||||2-Sided|95.0|-1.21|-0.22|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Relation to People score analysis|
1730197|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.39|||||2-Sided|95.0|-0.89|0.11|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Relation to People score analysis|
1730198|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.41|||||2-Sided|95.0|-0.92|0.11|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Normal Work score analysis|
1730199|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.35|||||2-Sided|95.0|-0.86|0.16|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Normal Work score analysis|
1730200|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.49|||||2-Sided|95.0|-1.01|0.03|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Walking Ability score analysis|
1730201|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.5|||||2-Sided|95.0|-1.02|0.02|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Walking Ability score analysis|
1730202|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.48|||||2-Sided|95.0|-1.01|0.05|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Mood score analysis|
1730203|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.27|||||2-Sided|95.0|-0.8|0.27|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Mood score analysis|
1730204|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.23|||||2-Sided|95.0|-0.77|0.32|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|General Activity score analysis|
1730205|NCT00552175|3186851|Superiority or Other||Least Squares Mean Difference|-0.6|||||2-Sided|95.0|-1.14|-0.06|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|General Activity score analysis|
1730206|NCT00552175|3186852|Superiority or Other||Least Squares Mean Difference|-0.48||||0.0095|2-Sided|95.0|-0.85|-0.12||P-value for Average of Interference Scores|Mixed Models Analysis|Covariates: Baseline value of average of interference scores, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730207|NCT00552175|3186852|Superiority or Other||Least Squares Mean Difference|-0.56||||0.0089|2-Sided|95.0|-0.98|-0.14||P-value for Enjoyment of Life.|Mixed Models Analysis|Covariates: Baseline value of enjoyment of life score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730208|NCT00552175|3186852|Superiority or Other||Least Squares Mean Difference|-0.46||||0.0378|2-Sided|95.0|-0.9|-0.03||P-value for Sleep.|Mixed Models Analysis|Covariates: Baseline value of sleep score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730209|NCT00552175|3186852|Superiority or Other||Least Squares Mean Difference|-0.55||||0.0076|2-Sided|95.0|-0.96|-0.15||P-value for Relation to People.|Mixed Models Analysis|Covariates: Baseline value of relation to people score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730210|NCT00552175|3186852|Superiority or Other||Least Squares Mean Difference|-0.38||||0.0783|2-Sided|95.0|-0.8|0.04||P-value for Normal Work.|Mixed Models Analysis|Covariates: Baseline value of normal work score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730211|NCT00552175|3186852|Superiority or Other||Least Squares Mean Difference|-0.49||||0.0228|2-Sided|95.0|-0.91|-0.07||P-value for Walking Ability.|Mixed Models Analysis|Covariates: Baseline value of walking ability score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730212|NCT00552175|3186852|Superiority or Other||Least Squares Mean Difference|-0.37||||0.0933|2-Sided|95.0|-0.8|0.06||P-value for Mood.|Mixed Models Analysis|Covariates: Baseline value of mood score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730213|NCT00552175|3186852|Superiority or Other||Least Squares Mean Difference|-0.41||||0.0676|2-Sided|95.0|-0.85|0.03||P-value for General Activity.|Mixed Models Analysis|Covariates: Baseline value of general activity score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730214|NCT00552175|3186853|Superiority or Other||Least Squares Mean Difference|-0.95|||||2-Sided|95.0|-1.41|-0.48|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Pain Right Now Score analysis|
1730215|NCT00552175|3186853|Superiority or Other||Least Squares Mean Difference|-0.88|||||2-Sided|95.0|-1.35|-0.41|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Pain Right Now Score analysis|
1730216|NCT00552175|3186853|Superiority or Other||Least Squares Mean Difference|-1.01|||||2-Sided|95.0|-1.41|-0.61|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average Pain Score analysis|
1730217|NCT00552175|3186853|Superiority or Other||Least Squares Mean Difference|-0.98|||||2-Sided|95.0|-1.39|-0.58|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Average Pain Score analysis|
1730218|NCT00552175|3186853|Superiority or Other||Least Mean Squares Difference|-0.91|||||2-Sided|95.0|-1.36|-0.46|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Least Pain Score analysis|
1730219|NCT00552175|3186853|Superiority or Other||Least Squares Mean Difference|-0.78|||||2-Sided|95.0|-1.23|-0.33|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Least Pain Score analysis|
1730220|NCT00552175|3186853|Superiority or Other||Least Squares Mean Difference|-1.06|||||2-Sided|95.0|-1.51|-0.62|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain Score analysis|
1730221|NCT00552175|3186853|Superiority or Other||Least Squares Mean Difference|-0.89|||||2-Sided|95.0|-1.34|-0.44|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain Score analysis|
1730222|NCT00552175|3186854|Superiority or Other||Least Squares Mean Difference|-0.92|||<|0.0001|2-Sided|95.0|-1.29|-0.54||P-value for Pain Right Now.|Mixed Models Analysis|Covariates: Baseline value of pain right now score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730223|NCT00552175|3186854|Superiority or Other||Least Squares Mean Difference|-1.0|||<|0.0001|2-Sided|95.0|-1.33|-0.67||P-value for Average Pain.|Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730224|NCT00552175|3186854|Superiority or Other||Least Squares Mean Difference|-0.85|||<|0.0001|2-Sided|95.0|-1.21|-0.48||P-value for Least Pain.|Mixed Models Analysis|Covariates: Baseline value of least pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730225|NCT00552175|3186854|Superiority or Other||Least Squares Mean Difference|-0.98|||<|0.0001|2-Sided|95.0|-1.34|-0.61||P-value for Worst Pain.|Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730226|NCT00552175|3186855|Superiority or Other||Least Squares Mean Difference|-0.65|||||2-Sided|95.0|-0.91|-0.4|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730227|NCT00552175|3186855|Superiority or Other||Least Squares Mean Difference|-0.65|||||2-Sided|95.0|-0.9|-0.39|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730228|NCT00552175|3186856|Superiority or Other||Least Squares Mean Difference|-0.65|||<|0.0001|2-Sided|95.0|-0.85|-0.44|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730229|NCT00552175|3186857|Superiority or Other||Least Squares Mean Difference|-0.89|||||2-Sided|95.0|-1.28|-0.5|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Night Pain analysis|
1730230|NCT00552175|3186857|Superiority or Other||Least Squares Mean Difference|-0.78|||||2-Sided|95.0|-1.17|-0.39|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Night Pain analysis|
1730231|NCT00552175|3186857|Superiority or Other||Least Squares Mean Difference|-1.05|||||2-Sided|95.0|-1.43|-0.66|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain analysis|
1730232|NCT00552175|3186857|Superiority or Other||Least Squares Mean Difference|-0.87|||||2-Sided|95.0|-1.26|-0.49|||||Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|Worst Pain analysis|
1730233|NCT00552175|3186858|Superiority or Other||Least Squares Mean Difference|-0.83|||<|0.0001|2-Sided|95.0|-1.15|-0.51||P-value for Night Pain.|Mixed Models Analysis|Covariates: Baseline value of night pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730234|NCT00552175|3186858|Superiority or Other||Least Squares Mean Difference|-0.96|||<|0.0001|2-Sided|95.0|-1.27|-0.64||P-value for Worst Pain.|Mixed Models Analysis|Covariates: Baseline value of worst pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.||
1730235|NCT00552175|3186860|Superiority or Other||Least Squares Mean Difference|-0.87|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-1.17|-0.56|||Mixed Models Analysis|Covariates: Baseline value of average pain score, type of Diabetes, Duration of diabetic peripheral neuropathic pain (DPNP).|Least Squares Mean Difference = Duloxetine 40 mg and 60 mg Combined minus Placebo.|The primary objective and primary efficacy analysis for the study was the analysis between the combined duloxetine arms and placebo.|
1730236|NCT00552110|3186861|Superiority or Other||||||<|0.001|||||||ANCOVA|||Null hypothesis: the administration of OXY twice daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of placebo|
1730237|NCT00552110|3186861|Superiority or Other||||||<|0.001|||||||ANCOVA|||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC (0-4hr) of the change from baseline in nasal congestion score as that of MFNS once daily|
1730238|NCT00552110|3186861|Superiority or Other||||||<|0.021||||||Multiplicity for multiple treatment comparisons was not adjusted.|ANCOVA|ANCOVA; classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same standardized AUC(0-4 hr) of the change from baseline in nasal congestion score as that of MFNS once daily.|
1730239|NCT00552110|3186862|Superiority or Other||||||<|0.001|||||||ANCOVA|||Null hypothesis: the administration of MFNS once daily has the same mean change from baseline in AM/PM NOW TNSS as that of placebo.|
1730240|NCT00552110|3186862|Superiority or Other||||||<|0.001|||||||ANCOVA|||Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily.|
1730241|NCT00552110|3186862|Superiority or Other||||||<|0.002||||||Multiplicity for multiple treatment comparisons was not adjusted.|ANCOVA|Analysis of Covariance (ANCOVA); classification variables: treatment, center, dosing sequence (stratification variable); covariate: baseline score||"Null hypothesis: the concurrent administration of MFNS and OXY once daily has the same mean change from baseline in AM/PM NOW TNSS as that of OXY twice daily.~Power calculation: The target randomization of 875 subjects (175 subjects per treatment arm) was needed to detect a treatment difference of 0.8 point or more in change from baseline in AM/PM NOW TNSS, with a two-sided alpha of 0.05 and 90% power, assuming a pooled standard deviation of 2.3 points."|
1730242|NCT00552071|3186864|Other|||||||0.43||||||A two-sided p value of <0.05 was considered significant.|t-test, 2 sided||||
1730243|NCT00552071|3186865|Other|||||||0.4||||||A two-sided p value of <0.05 was considered significant.|t-test, 2 sided||||
1730244|NCT00551525|3186918|Superiority or Other||Odds Ratio (OR)|0.659|||||2-Sided|95.0|0.217|2.006||||||Modeling the association of Gleason score (<8 vs. 8-10[reference level]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 [reference level]), baseline PSA, and age.|
1730245|NCT00551525|3186918|Superiority or Other||Odds Ratio (OR)|1.307|||||2-Sided|95.0|0.364|4.697||||||Modeling the association of clinical T-stage (pT2 vs. pT3 [reference level]) with the occurrence of any acute radiotherapy-related adverse event, adjusting for baseline PSA, Gleason score (<8 vs. 8-10[reference level]), and age.|
1730246|NCT00551525|3186918|Superiority or Other||Odds Ratio (OR)|1.02|||||2-Sided|95.0|0.89|1.169||||||Modeling the association of baseline PSA with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 [reference level]), Gleason score (<8 vs. 8-10[reference level]), and age.|
1730247|NCT00551525|3186918|Superiority or Other||Odds Ratio (OR)|0.984|||||2-Sided|95.0|0.91|1.063||||||Modeling the association of age with the occurrence of any acute radiotherapy-related adverse event, adjusting for clinical T-stage (pT2 vs. pT3 [reference level]), baseline PSA, and Gleason score (<8 vs. 8-10[reference level]).|
1730248|NCT00551525|3186921|Superiority or Other||||||<|0.001||||||Significance level 0.05, two-sided test|binomial proportion||||
1730271|NCT00551135|3186960|Superiority or Other|||||||0.9275|||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730851|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.42|Standard Error of the Mean|0.13|||2-Sided|95.0|0.16|0.68||||||Day 2, 0 hours postdose|
1730249|NCT00551161|3186954|Superiority or Other||||||<|0.05||||||Due to the exploratory nature of these analyses, no adjustment for multiple testing was made. Although it would have been preferable to carry out an omnibus analysis, due to the small sample size, the descriptive approach described above was used.|Wilcoxon (Mann-Whitney)|||The Wilcoxon signed-rank test was used to examine whether the change between t0 and t1 differed from the change between t1 and t2 [(t2 – t1) – (t1 – t0)] for each of the metabolites and ratios, in order to examine whether the rate of change differed while on monotherapy as compared with combination therapy.|
1730250|NCT00551135|3186957|Superiority or Other|||||||0.3173||||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.|
1730251|NCT00551135|3186957|Superiority or Other|||||||0.2733||||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.|
1730252|NCT00551135|3186957|Superiority or Other|||||||0.4795||||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||6 month PS.|
1730253|NCT00551135|3186957|Superiority or Other|||||||0.4453||||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.|
1730254|NCT00551135|3186957|Superiority or Other|||||||0.5592||||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.|
1730255|NCT00551135|3186957|Superiority or Other|||||||0.8169||||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||3 month PS.|
1730256|NCT00551135|3186957|Superiority or Other|||||||0.1692||||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.|
1730257|NCT00551135|3186957|Superiority or Other|||||||0.4435||||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.|
1730258|NCT00551135|3186957|Superiority or Other|||||||0.2371||||||P-values are derived from Cochran-Mantel-Haenszel test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||1 month PS.|
1730259|NCT00551135|3186958|Superiority or Other|||||||0.0832|||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.|
1730260|NCT00551135|3186958|Superiority or Other|||||||0.2524|||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.|
1730261|NCT00551135|3186958|Superiority or Other|||||||0.2639|||||||ANOVA|||MCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.|
1730262|NCT00551135|3186958|Superiority or Other|||||||0.2023|||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.|
1730263|NCT00551135|3186958|Superiority or Other|||||||0.138|||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.|
1730264|NCT00551135|3186958|Superiority or Other|||||||0.1122|||||||ANOVA|||MCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.|
1730265|NCT00551135|3186958|Superiority or Other|||||||0.349|||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.|
1730266|NCT00551135|3186958|Superiority or Other|||||||0.407|||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.|
1730267|NCT00551135|3186958|Superiority or Other|||||||0.3245|||||||ANOVA|||PCSS change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.|
1730268|NCT00551135|3186958|Superiority or Other|||||||0.2131|||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.|
1730269|NCT00551135|3186958|Superiority or Other|||||||0.0094|||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.|
1730270|NCT00551135|3186958|Superiority or Other|||||||0.2136|||||||ANOVA|||PCSS at baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects have were combined into pooled centers.|
1730361|NCT00551135|3186966|Superiority or Other|||||||0.9634||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;|
1730272|NCT00551135|3186960|Superiority or Other|||||||0.6365|||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730273|NCT00551135|3186960|Superiority or Other|||||||0.8667|||||||ANOVA|||Helplessness change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730274|NCT00551135|3186960|Superiority or Other|||||||0.0632|||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730275|NCT00551135|3186960|Superiority or Other|||||||0.1128|||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730276|NCT00551135|3186960|Superiority or Other|||||||0.043|||||||ANOVA|||Helplessness change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730277|NCT00551135|3186960|Superiority or Other|||||||0.3382|||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730278|NCT00551135|3186960|Superiority or Other|||||||0.2146|||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730279|NCT00551135|3186960|Superiority or Other|||||||0.5985|||||||ANOVA|||Magnification change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730280|NCT00551135|3186960|Superiority or Other|||||||0.2265|||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730281|NCT00551135|3186960|Superiority or Other|||||||0.4385|||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730282|NCT00551135|3186960|Superiority or Other|||||||0.4465|||||||ANOVA|||Magnification change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730283|NCT00551135|3186960|Superiority or Other|||||||0.399|||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730284|NCT00551135|3186960|Superiority or Other|||||||0.7774|||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730285|NCT00551135|3186960|Superiority or Other|||||||0.2965|||||||ANOVA|||Rumination change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730286|NCT00551135|3186960|Superiority or Other|||||||0.1125|||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730287|NCT00551135|3186960|Superiority or Other|||||||0.5267|||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730288|NCT00551135|3186960|Superiority or Other|||||||0.1561|||||||ANOVA|||Rumination change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730289|NCT00551135|3186960|Superiority or Other|||||||0.4809|||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730290|NCT00551135|3186960|Superiority or Other|||||||0.9713|||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730291|NCT00551135|3186960|Superiority or Other|||||||0.5721|||||||ANOVA|||Total score change at EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730292|NCT00551135|3186960|Superiority or Other|||||||0.0629|||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1734625|NCT00509392|3193653|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1730293|NCT00551135|3186960|Superiority or Other|||||||0.2339|||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730294|NCT00551135|3186960|Superiority or Other|||||||0.083|||||||ANOVA|||Total score change at 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730295|NCT00551135|3186961|Superiority or Other|||||||0.1218|||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730296|NCT00551135|3186961|Superiority or Other|||||||0.2142|||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730297|NCT00551135|3186961|Superiority or Other|||||||0.2033|||||||ANOVA|||Change at EOT; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730298|NCT00551135|3186961|Superiority or Other|||||||0.4233|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730299|NCT00551135|3186961|Superiority or Other|||||||0.5092|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730300|NCT00551135|3186961|Superiority or Other|||||||0.7936|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline item score and basline PCS (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730301|NCT00551135|3186962|Superiority or Other|||||||0.4882|||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730302|NCT00551135|3186962|Superiority or Other|||||||0.177|||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730303|NCT00551135|3186962|Superiority or Other|||||||0.1632|||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730304|NCT00551135|3186962|Superiority or Other|||||||0.6158|||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730305|NCT00551135|3186962|Superiority or Other|||||||0.664|||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730306|NCT00551135|3186962|Superiority or Other|||||||0.461|||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730307|NCT00551135|3186962|Superiority or Other|||||||0.5547|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730308|NCT00551135|3186962|Superiority or Other|||||||0.0693|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730309|NCT00551135|3186962|Superiority or Other|||||||0.6858|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730310|NCT00551135|3186962|Superiority or Other|||||||0.5561|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730311|NCT00551135|3186962|Superiority or Other|||||||0.1285|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730312|NCT00551135|3186962|Superiority or Other|||||||0.8515|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730313|NCT00551135|3186962|Superiority or Other|||||||0.8031|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1731480|NCT00543569|3188239|Superiority or Other||Difference|4.3|||||2-Sided|90.0|-3.6|12.3||||||BCAR at Month 6|
1730314|NCT00551135|3186962|Superiority or Other|||||||0.1198|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730315|NCT00551135|3186962|Superiority or Other|||||||0.7461|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730316|NCT00551135|3186962|Superiority or Other|||||||0.6974|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730317|NCT00551135|3186962|Superiority or Other|||||||0.0221|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730318|NCT00551135|3186962|Superiority or Other|||||||0.8231|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730319|NCT00551135|3186962|Superiority or Other|||||||0.2463|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730320|NCT00551135|3186962|Superiority or Other|||||||0.0456|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730321|NCT00551135|3186962|Superiority or Other|||||||0.9049|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730322|NCT00551135|3186962|Superiority or Other|||||||0.4198|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730323|NCT00551135|3186962|Superiority or Other|||||||0.0342|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730324|NCT00551135|3186962|Superiority or Other|||||||0.3282|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730325|NCT00551135|3186962|Superiority or Other|||||||0.1808|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730326|NCT00551135|3186962|Superiority or Other|||||||0.3228|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730327|NCT00551135|3186962|Superiority or Other|||||||0.2269|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730328|NCT00551135|3186962|Superiority or Other|||||||0.6415|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730329|NCT00551135|3186962|Superiority or Other|||||||0.4885|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730330|NCT00551135|3186962|Superiority or Other|||||||0.2665|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730331|NCT00551135|3186962|Superiority or Other|||||||0.399|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730332|NCT00551135|3186962|Superiority or Other|||||||0.8999|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730333|NCT00551135|3186962|Superiority or Other|||||||0.1628|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730334|NCT00551135|3186962|Superiority or Other|||||||0.1821|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1731481|NCT00543569|3188239|Superiority or Other||Difference|10.6|||||2-Sided|90.0|1.8|19.5||||||BCAR at Month 6|
1730335|NCT00551135|3186962|Superiority or Other|||||||0.6098|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730336|NCT00551135|3186962|Superiority or Other|||||||0.0557|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730337|NCT00551135|3186962|Superiority or Other|||||||0.4781|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730338|NCT00551135|3186962|Superiority or Other|||||||0.2821|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730339|NCT00551135|3186962|Superiority or Other|||||||0.1682|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center, baseline VAS score and baseline PCS score (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730340|NCT00551135|3186963|Superiority or Other|||||||0.8061||||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.|
1730341|NCT00551135|3186963|Superiority or Other|||||||0.4354||||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.|
1730342|NCT00551135|3186963|Superiority or Other|||||||0.9869||||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS.|
1730343|NCT00551135|3186963|Superiority or Other|||||||0.3865||||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||72 h PS|
1730344|NCT00551135|3186963|Superiority or Other|||||||0.1927||||||P-values derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjests have been combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.|
1730345|NCT00551135|3186965|Superiority or Other|||||||0.0012||||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.|
1730346|NCT00551135|3186965|Superiority or Other|||||||0.0703||||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.|
1730347|NCT00551135|3186965|Superiority or Other|||||||0.1127||||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||EOT.|
1730348|NCT00551135|3186965|Superiority or Other|||||||0.0021||||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.|
1730349|NCT00551135|3186965|Superiority or Other|||||||0.0639||||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS|
1730350|NCT00551135|3186965|Superiority or Other|||||||0.1723||||||P-values derived from Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||24 h PS.|
1730351|NCT00551135|3186966|Superiority or Other|||||||0.4386||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;|
1730352|NCT00551135|3186966|Superiority or Other|||||||0.3173||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;|
1730353|NCT00551135|3186966|Superiority or Other|||||||0.3173||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at EOT;|
1730354|NCT00551135|3186966|Superiority or Other|||||||0.2482||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;|
1730355|NCT00551135|3186966|Superiority or Other|||||||0.8091||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;|
1730356|NCT00551135|3186966|Superiority or Other|||||||0.2482||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 24 h PS;|
1730357|NCT00551135|3186966|Superiority or Other|||||||0.0711||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;|
1730358|NCT00551135|3186966|Superiority or Other|||||||0.0711||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;|
1730359|NCT00551135|3186966|Superiority or Other|||||||0.0754||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Retching/Vomiting at 3 h PS;|
1730360|NCT00551135|3186966|Superiority or Other|||||||0.1161||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;|
1730362|NCT00551135|3186966|Superiority or Other|||||||0.1672||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at EOT;|
1730363|NCT00551135|3186966|Superiority or Other|||||||0.7675||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;|
1730364|NCT00551135|3186966|Superiority or Other|||||||0.58||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;|
1730365|NCT00551135|3186966|Superiority or Other|||||||0.9522||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 72 h PS;|
1730366|NCT00551135|3186966|Superiority or Other|||||||0.6419||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;|
1730367|NCT00551135|3186966|Superiority or Other|||||||0.846||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;|
1730368|NCT00551135|3186966|Superiority or Other|||||||1||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 24 h PS;|
1730369|NCT00551135|3186966|Superiority or Other|||||||0.7655||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;|
1730370|NCT00551135|3186966|Superiority or Other|||||||0.9024||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;|
1730371|NCT00551135|3186966|Superiority or Other|||||||0.9283||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Confusion at 3 h PS;|
1730372|NCT00551135|3186966|Superiority or Other|||||||0.0719||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at EOT;|
1730373|NCT00551135|3186966|Superiority or Other|||||||0.2943||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at EOT;|
1730374|NCT00551135|3186966|Superiority or Other|||||||0.0676||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 72 h PS;|
1730375|NCT00551135|3186966|Superiority or Other|||||||0.175||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 72 h PS;|
1730376|NCT00551135|3186966|Superiority or Other|||||||0.5795||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;|
1730377|NCT00551135|3186966|Superiority or Other|||||||0.8149||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;|
1730378|NCT00551135|3186966|Superiority or Other|||||||0.6319||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 24 h PS;|
1730379|NCT00551135|3186966|Superiority or Other|||||||0.6318||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;|
1730380|NCT00551135|3186966|Superiority or Other|||||||0.1391||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;|
1730381|NCT00551135|3186966|Superiority or Other|||||||0.3291||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Difficulty Urinating at 3 h PS;|
1730382|NCT00551135|3186966|Superiority or Other|||||||0.2482||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;|
1730383|NCT00551135|3186966|Superiority or Other|||||||0.2207||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;|
1730384|NCT00551135|3186966|Superiority or Other|||||||0.2482||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at EOT;|
1730385|NCT00551135|3186966|Superiority or Other|||||||0.2482||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;|
1730386|NCT00551135|3186966|Superiority or Other|||||||0.8488||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;|
1730387|NCT00551135|3186966|Superiority or Other|||||||0.9191||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 72 h PS;|
1730388|NCT00551135|3186966|Superiority or Other|||||||0.8055||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;|
1731482|NCT00543569|3188240|Superiority or Other||Difference|2.8|||||2-Sided|90.0|-7.1|12.6|||||||
1730389|NCT00551135|3186966|Superiority or Other|||||||0.2207||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;|
1730390|NCT00551135|3186966|Superiority or Other|||||||0.2482||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 24 h PS;|
1730391|NCT00551135|3186966|Superiority or Other|||||||0.2482||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Itching at 3 h PS;|
1730392|NCT00551135|3186966|Superiority or Other|||||||0.3304||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;|
1730393|NCT00551135|3186966|Superiority or Other|||||||0.8295||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;|
1730394|NCT00551135|3186966|Superiority or Other|||||||0.4821||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at EOT;|
1730395|NCT00551135|3186966|Superiority or Other|||||||0.5299||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;|
1730396|NCT00551135|3186966|Superiority or Other|||||||0.969||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;|
1730397|NCT00551135|3186966|Superiority or Other|||||||0.357||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 72 h PS;|
1730398|NCT00551135|3186966|Superiority or Other|||||||0.6065||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;|
1730399|NCT00551135|3186966|Superiority or Other|||||||0.7793||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;|
1730400|NCT00551135|3186966|Superiority or Other|||||||0.6692||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 24 h PS;|
1730401|NCT00551135|3186966|Superiority or Other|||||||0.2207||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;|
1730402|NCT00551135|3186966|Superiority or Other|||||||0.3173||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;|
1730403|NCT00551135|3186966|Superiority or Other|||||||0.9191||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Constipation at 3 h PS;|
1730404|NCT00551135|3186966|Superiority or Other|||||||0.3173||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at EOT;|
1730405|NCT00551135|3186966|Superiority or Other|||||||0.2207||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at EOT;|
1730406|NCT00551135|3186966|Superiority or Other|||||||0.3061||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 72 h PS;|
1730407|NCT00551135|3186966|Superiority or Other|||||||0.0617||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;|
1730408|NCT00551135|3186966|Superiority or Other|||||||0.3625||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;|
1730409|NCT00551135|3186966|Superiority or Other|||||||0.477||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 24 h PS;|
1730410|NCT00551135|3186966|Superiority or Other|||||||0.7728||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;|
1730411|NCT00551135|3186966|Superiority or Other|||||||0.0807||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;|
1730412|NCT00551135|3186966|Superiority or Other|||||||0.1703||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Dizziness at 3 h PS;|
1730413|NCT00551135|3186966|Superiority or Other|||||||0.3943||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;|
1730414|NCT00551135|3186966|Superiority or Other|||||||0.3173||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;|
1730415|NCT00551135|3186966|Superiority or Other|||||||1||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at EOT;|
1730852|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.57|-0.04||||||Day 2, 0 hours postdose|
1730416|NCT00551135|3186966|Superiority or Other|||||||0.2896||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;|
1730417|NCT00551135|3186966|Superiority or Other|||||||0.2199||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;|
1730418|NCT00551135|3186966|Superiority or Other|||||||0.4106||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 24 h PS;|
1730419|NCT00551135|3186966|Superiority or Other|||||||0.2054||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;|
1730420|NCT00551135|3186966|Superiority or Other|||||||0.145||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;|
1730421|NCT00551135|3186966|Superiority or Other|||||||0.3747||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Nausea at 3 h PS;|
1730422|NCT00551135|3186966|Superiority or Other|||||||0.2207||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;|
1730423|NCT00551135|3186966|Superiority or Other|||||||0.3173||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;|
1730424|NCT00551135|3186966|Superiority or Other|||||||0.8084||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at EOT;|
1730425|NCT00551135|3186966|Superiority or Other|||||||0.8864||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;|
1730426|NCT00551135|3186966|Superiority or Other|||||||0.3173||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;|
1730427|NCT00551135|3186966|Superiority or Other|||||||0.3173||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 72 h PS;|
1730428|NCT00551135|3186966|Superiority or Other|||||||0.8852||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;|
1730429|NCT00551135|3186966|Superiority or Other|||||||0.3533||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;|
1730430|NCT00551135|3186966|Superiority or Other|||||||0.4793||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 24 h PS;|
1730431|NCT00551135|3186966|Superiority or Other|||||||0.1611||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;|
1730432|NCT00551135|3186966|Superiority or Other|||||||0.1611||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;|
1730433|NCT00551135|3186966|Superiority or Other|||||||0.5533||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Inability to Concentrate at 3 h PS;|
1730434|NCT00551135|3186966|Superiority or Other|||||||0.4669||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;|
1730435|NCT00551135|3186966|Superiority or Other|||||||0.0746||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;|
1730436|NCT00551135|3186966|Superiority or Other|||||||0.0686||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at EOT;|
1730437|NCT00551135|3186966|Superiority or Other|||||||0.1979||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;|
1730438|NCT00551135|3186966|Superiority or Other|||||||0.0894||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;|
1730439|NCT00551135|3186966|Superiority or Other|||||||0.288||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 72 h PS;|
1730440|NCT00551135|3186966|Superiority or Other|||||||0.1232||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;|
1730441|NCT00551135|3186966|Superiority or Other|||||||0.2579||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;|
1730442|NCT00551135|3186966|Superiority or Other|||||||0.5457||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 24 h PS;|
1730443|NCT00551135|3186966|Superiority or Other|||||||0.977||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;|
1730444|NCT00551135|3186966|Superiority or Other|||||||0.9883||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;|
1730445|NCT00551135|3186966|Superiority or Other|||||||0.7118||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Drowsiness at 3 h PS;|
1730446|NCT00551135|3186966|Superiority or Other|||||||0.0512||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;|
1730447|NCT00551135|3186966|Superiority or Other|||||||0.0746||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;|
1730448|NCT00551135|3186966|Superiority or Other|||||||0.0686||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at EOT;|
1730449|NCT00551135|3186966|Superiority or Other|||||||0.9191||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;|
1730450|NCT00551135|3186966|Superiority or Other|||||||0.2207||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;|
1730451|NCT00551135|3186966|Superiority or Other|||||||0.2482||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 72 h PS;|
1730452|NCT00551135|3186966|Superiority or Other|||||||0.2134||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;|
1730453|NCT00551135|3186966|Superiority or Other|||||||0.937||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;|
1730454|NCT00551135|3186966|Superiority or Other|||||||0.9038||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 24 h PS;|
1730455|NCT00551135|3186966|Superiority or Other|||||||0.9975||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;|
1730456|NCT00551135|3186966|Superiority or Other|||||||0.9766||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;|
1730457|NCT00551135|3186966|Superiority or Other|||||||0.4024||||||P-values are derived from CMH test adjusted for pooled centers. Centers with fewer than 8 treated subjects were combined into pooled centers.|Cochran-Mantel-Haenszel|||Fatigue at 3 h PS;|
1730458|NCT00551135|3186967|Superiority or Other|||||||0.8869|||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730459|NCT00551135|3186967|Superiority or Other|||||||0.5383|||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730460|NCT00551135|3186967|Superiority or Other|||||||0.1472|||||||ANOVA|||CT Distinct CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730461|NCT00551135|3186967|Superiority or Other|||||||0.925|||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730462|NCT00551135|3186967|Superiority or Other|||||||0.7887|||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730463|NCT00551135|3186967|Superiority or Other|||||||0.2158|||||||ANOVA|||CT Distinct CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730464|NCT00551135|3186967|Superiority or Other|||||||0.9381|||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730465|NCT00551135|3186967|Superiority or Other|||||||0.9905|||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730466|NCT00551135|3186967|Superiority or Other|||||||0.2869|||||||ANOVA|||CT Distinct CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730467|NCT00551135|3186967|Superiority or Other|||||||0.3785|||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730468|NCT00551135|3186967|Superiority or Other|||||||0.4466|||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730853|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.46|0.07||||||Day 2, 0 hours postdose|
1730469|NCT00551135|3186967|Superiority or Other|||||||0.4273|||||||ANOVA|||CT Distinct CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730470|NCT00551135|3186967|Superiority or Other|||||||0.9599|||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730471|NCT00551135|3186967|Superiority or Other|||||||0.1351|||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730472|NCT00551135|3186967|Superiority or Other|||||||0.0549|||||||ANOVA|||Total CME EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730473|NCT00551135|3186967|Superiority or Other|||||||0.5367|||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730474|NCT00551135|3186967|Superiority or Other|||||||0.3468|||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730475|NCT00551135|3186967|Superiority or Other|||||||0.2316|||||||ANOVA|||Total CME 72 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730476|NCT00551135|3186967|Superiority or Other|||||||0.1428|||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730477|NCT00551135|3186967|Superiority or Other|||||||0.4257|||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730478|NCT00551135|3186967|Superiority or Other|||||||0.5272|||||||ANOVA|||Total CME 24 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730479|NCT00551135|3186967|Superiority or Other|||||||0.3785|||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730480|NCT00551135|3186967|Superiority or Other|||||||0.4466|||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730481|NCT00551135|3186967|Superiority or Other|||||||0.4273|||||||ANOVA|||Total CME 3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730482|NCT00551135|3186968|Superiority or Other|||||||0.556|||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730483|NCT00551135|3186968|Superiority or Other|||||||0.441|||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730484|NCT00551135|3186968|Superiority or Other|||||||0.4177|||||||ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730485|NCT00551135|3186969|Superiority or Other|||||||0.0406|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730486|NCT00551135|3186969|Superiority or Other|||||||0.3086|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730487|NCT00551135|3186969|Superiority or Other|||||||0.0347|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730488|NCT00551135|3186969|Superiority or Other|||||||0.0467|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730489|NCT00551135|3186969|Superiority or Other|||||||0.3384|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730490|NCT00551135|3186969|Superiority or Other|||||||0.0487|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730491|NCT00551135|3186969|Superiority or Other|||||||0.0345|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730492|NCT00551135|3186969|Superiority or Other|||||||0.3242|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730493|NCT00551135|3186969|Superiority or Other|||||||0.0651|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730494|NCT00551135|3186969|Superiority or Other|||||||0.0388|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730495|NCT00551135|3186969|Superiority or Other|||||||0.2629|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1731483|NCT00543569|3188240|Superiority or Other||Difference|4.8|||||2-Sided|90.0|-5.4|15.0|||||||
1730496|NCT00551135|3186969|Superiority or Other|||||||0.0673|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730497|NCT00551135|3186969|Superiority or Other|||||||0.0193|||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730498|NCT00551135|3186969|Superiority or Other|||||||0.2173|||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730499|NCT00551135|3186969|Superiority or Other|||||||0.0694|||||||ANOVA|||72 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730500|NCT00551135|3186969|Superiority or Other|||||||0.0078|||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730501|NCT00551135|3186969|Superiority or Other|||||||0.1327|||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730502|NCT00551135|3186969|Superiority or Other|||||||0.0767|||||||ANOVA|||48 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730503|NCT00551135|3186969|Superiority or Other|||||||0.0024|||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730504|NCT00551135|3186969|Superiority or Other|||||||0.0347|||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730505|NCT00551135|3186969|Superiority or Other|||||||0.063|||||||ANOVA|||24 h PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730506|NCT00551135|3186970|Superiority or Other|||||||0.1694|||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730507|NCT00551135|3186970|Superiority or Other|||||||0.3478|||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730508|NCT00551135|3186970|Superiority or Other|||||||0.2426|||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730509|NCT00551135|3186970|Superiority or Other|||||||0.0473|||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730510|NCT00551135|3186970|Superiority or Other|||||||0.9929|||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730511|NCT00551135|3186970|Superiority or Other|||||||0.0058|||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730512|NCT00551135|3186970|Superiority or Other|||||||0.8956|||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730513|NCT00551135|3186970|Superiority or Other|||||||0.264|||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730514|NCT00551135|3186970|Superiority or Other|||||||0.1285|||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730515|NCT00551135|3186970|Superiority or Other|||||||0.1684|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730516|NCT00551135|3186970|Superiority or Other|||||||0.614|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730517|NCT00551135|3186970|Superiority or Other|||||||0.8273|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730518|NCT00551135|3186970|Superiority or Other|||||||0.1078|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730519|NCT00551135|3186970|Superiority or Other|||||||0.446|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730520|NCT00551135|3186970|Superiority or Other|||||||0.3338|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730521|NCT00551135|3186970|Superiority or Other|||||||0.1366|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730522|NCT00551135|3186970|Superiority or Other|||||||0.3348|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730523|NCT00551135|3186970|Superiority or Other|||||||0.0785|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730524|NCT00551135|3186970|Superiority or Other|||||||0.4285|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730525|NCT00551135|3186970|Superiority or Other|||||||0.7672|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730526|NCT00551135|3186970|Superiority or Other|||||||0.8936|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730527|NCT00551135|3186970|Superiority or Other|||||||0.0348|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730528|NCT00551135|3186970|Superiority or Other|||||||0.7312|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730529|NCT00551135|3186970|Superiority or Other|||||||0.9451|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730530|NCT00551135|3186970|Superiority or Other|||||||0.0031|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730531|NCT00551135|3186970|Superiority or Other|||||||0.0933|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730532|NCT00551135|3186970|Superiority or Other|||||||0.3332|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730533|NCT00551135|3186974|Superiority or Other|||||||0.7015|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730534|NCT00551135|3186974|Superiority or Other|||||||0.5225|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730535|NCT00551135|3186974|Superiority or Other|||||||0.2796|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730536|NCT00551135|3186974|Superiority or Other|||||||0.8849|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730537|NCT00551135|3186974|Superiority or Other|||||||0.4445|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730538|NCT00551135|3186974|Superiority or Other|||||||0.2348|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730539|NCT00551135|3186974|Superiority or Other|||||||0.8805|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730540|NCT00551135|3186974|Superiority or Other|||||||0.9099|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730541|NCT00551135|3186974|Superiority or Other|||||||0.4461|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730542|NCT00551135|3186974|Superiority or Other|||||||0.4047|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730543|NCT00551135|3186974|Superiority or Other|||||||0.626|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730544|NCT00551135|3186974|Superiority or Other|||||||0.8978|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730545|NCT00551135|3186974|Superiority or Other|||||||0.7104|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730546|NCT00551135|3186974|Superiority or Other|||||||0.9677|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730547|NCT00551135|3186974|Superiority or Other|||||||0.8581|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730548|NCT00551135|3186974|Superiority or Other|||||||0.7984|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730549|NCT00551135|3186974|Superiority or Other|||||||0.3246|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730550|NCT00551135|3186974|Superiority or Other|||||||0.9681|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730551|NCT00551135|3186974|Superiority or Other|||||||0.0747|||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730552|NCT00551135|3186974|Superiority or Other|||||||0.9664|||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1731484|NCT00543569|3188240|Superiority or Other||Difference|13.7|||||2-Sided|90.0|2.8|24.6|||||||
1730553|NCT00551135|3186974|Superiority or Other|||||||0.9391|||||||ANOVA|||Day 1 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730554|NCT00551135|3186974|Superiority or Other|||||||0.1883|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730555|NCT00551135|3186974|Superiority or Other|||||||0.9822|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730556|NCT00551135|3186974|Superiority or Other|||||||0.1132|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730557|NCT00551135|3186974|Superiority or Other|||||||0.1619|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730558|NCT00551135|3186974|Superiority or Other|||||||0.7426|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730559|NCT00551135|3186974|Superiority or Other|||||||0.6811|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730560|NCT00551135|3186974|Superiority or Other|||||||0.0111|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730561|NCT00551135|3186974|Superiority or Other|||||||0.3751|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730562|NCT00551135|3186974|Superiority or Other|||||||0.093|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730563|NCT00551135|3186974|Superiority or Other|||||||0.6781|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730564|NCT00551135|3186974|Superiority or Other|||||||0.7308|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730565|NCT00551135|3186974|Superiority or Other|||||||0.6679|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730566|NCT00551135|3186975|Superiority or Other|||||||0.792|||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."|
1730567|NCT00551135|3186975|Superiority or Other|||||||0.5652|||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."|
1730568|NCT00551135|3186975|Superiority or Other|||||||0.9025|||||||ANOVA|||"LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."|
1730569|NCT00551135|3186976|Superiority or Other|||||||0.9631|||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730570|NCT00551135|3186976|Superiority or Other|||||||0.9346|||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730571|NCT00551135|3186976|Superiority or Other|||||||0.3695|||||||ANOVA|||Day 10 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730572|NCT00551135|3186976|Superiority or Other|||||||0.0029|||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730573|NCT00551135|3186976|Superiority or Other|||||||0.0696|||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730574|NCT00551135|3186976|Superiority or Other|||||||0.0002|||||||ANOVA|||Day 9 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730575|NCT00551135|3186976|Superiority or Other|||||||0.654|||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730854|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.18|0.34||||||Day 1, 12 hours postdose|
1730576|NCT00551135|3186976|Superiority or Other|||||||0.4373|||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730577|NCT00551135|3186976|Superiority or Other|||||||0.3082|||||||ANOVA|||Day 8 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730578|NCT00551135|3186976|Superiority or Other|||||||0.9774|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730579|NCT00551135|3186976|Superiority or Other|||||||0.5374|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730580|NCT00551135|3186976|Superiority or Other|||||||0.7883|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730581|NCT00551135|3186976|Superiority or Other|||||||0.6881|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730582|NCT00551135|3186976|Superiority or Other|||||||0.7602|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730583|NCT00551135|3186976|Superiority or Other|||||||0.2938|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730584|NCT00551135|3186976|Superiority or Other|||||||0.8474|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730585|NCT00551135|3186976|Superiority or Other|||||||0.8788|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730586|NCT00551135|3186976|Superiority or Other|||||||0.1733|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730587|NCT00551135|3186976|Superiority or Other|||||||0.6606|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730588|NCT00551135|3186976|Superiority or Other|||||||0.4522|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730589|NCT00551135|3186976|Superiority or Other|||||||0.4352|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730590|NCT00551135|3186976|Superiority or Other|||||||0.9386|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730591|NCT00551135|3186976|Superiority or Other|||||||0.0869|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730592|NCT00551135|3186976|Superiority or Other|||||||0.3204|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730593|NCT00551135|3186976|Superiority or Other|||||||0.9666|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730594|NCT00551135|3186976|Superiority or Other|||||||0.9709|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730595|NCT00551135|3186976|Superiority or Other|||||||0.8139|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730596|NCT00551135|3186976|Superiority or Other|||||||0.5944|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730597|NCT00551135|3186976|Superiority or Other|||||||0.8379|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730598|NCT00551135|3186976|Superiority or Other|||||||0.4418|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730599|NCT00551135|3186976|Superiority or Other|||||||0.2732|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730600|NCT00551135|3186976|Superiority or Other|||||||0.384|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730601|NCT00551135|3186976|Superiority or Other|||||||0.707|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1734747|NCT00506675|3193984|Superiority or Other|||||||0.3|||||||ANCOVA||||
1730602|NCT00551135|3186976|Superiority or Other|||||||0.0004|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730603|NCT00551135|3186976|Superiority or Other|||||||0.5509|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730604|NCT00551135|3186976|Superiority or Other|||||||0.0401|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730605|NCT00551135|3186976|Superiority or Other|||||||0.5074|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730606|NCT00551135|3186976|Superiority or Other|||||||0.8631|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730607|NCT00551135|3186976|Superiority or Other|||||||0.2818|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain catastrophizing total score. Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730608|NCT00551135|3186977|Superiority or Other|||||||0.105|||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."|
1730609|NCT00551135|3186977|Superiority or Other|||||||0.96|||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."|
1730610|NCT00551135|3186977|Superiority or Other|||||||0.1812|||||||ANOVA|||"Coughing; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by coughing. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."|
1730611|NCT00551135|3186977|Superiority or Other|||||||0.1259|||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."|
1730612|NCT00551135|3186977|Superiority or Other|||||||0.9367|||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."|
1730613|NCT00551135|3186977|Superiority or Other|||||||0.1318|||||||ANOVA|||"Walking; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by walking. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."|
1730614|NCT00551135|3186977|Superiority or Other|||||||0.5064|||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."|
1730615|NCT00551135|3186977|Superiority or Other|||||||0.764|||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."|
1730616|NCT00551135|3186977|Superiority or Other|||||||0.397|||||||ANOVA|||"Sitting; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain caused by sitting. Centers with fewer than 8 treated subjects were combined into pooled centers.~Last observation carried forward algorithm or first non-missing observation carried backward algorithm applied to missing scores 1-3 h PS and independently to missing scores 24-48 h PS, before applying trapezoidal rule to compute AUC. AUC=missing if all scores 1-3 or 24-48 h PS missing."|
1730617|NCT00551135|3186978|Superiority or Other|||||||0.8423|||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730618|NCT00551135|3186978|Superiority or Other|||||||0.2813|||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730768|NCT00550173|3187179|Superiority or Other|||||||0.194|||||||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730619|NCT00551135|3186978|Superiority or Other|||||||0.1647|||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730620|NCT00551135|3186978|Superiority or Other|||||||0.7336|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730621|NCT00551135|3186978|Superiority or Other|||||||0.5852|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730622|NCT00551135|3186978|Superiority or Other|||||||0.4216|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730623|NCT00551135|3186978|Superiority or Other|||||||0.3832|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730624|NCT00551135|3186978|Superiority or Other|||||||0.1976|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730625|NCT00551135|3186978|Superiority or Other|||||||0.0547|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730626|NCT00551135|3186978|Superiority or Other|||||||0.0773|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730627|NCT00551135|3186978|Superiority or Other|||||||0.0493|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730628|NCT00551135|3186978|Superiority or Other|||||||0.005|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730629|NCT00551135|3186978|Superiority or Other|||||||0.3746|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730630|NCT00551135|3186978|Superiority or Other|||||||0.3263|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730631|NCT00551135|3186978|Superiority or Other|||||||0.2624|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730632|NCT00551135|3186978|Superiority or Other|||||||0.5527|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730633|NCT00551135|3186978|Superiority or Other|||||||0.9224|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730634|NCT00551135|3186978|Superiority or Other|||||||0.5788|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730635|NCT00551135|3186978|Superiority or Other|||||||0.0325|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730636|NCT00551135|3186978|Superiority or Other|||||||0.6333|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730637|NCT00551135|3186978|Superiority or Other|||||||0.0692|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730638|NCT00551135|3186978|Superiority or Other|||||||0.7297|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730639|NCT00551135|3186978|Superiority or Other|||||||0.453|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730769|NCT00550173|3187180|Superiority or Other||Odds Ratio, log|0.27||||0.004|2-Sided|95.0|0.11|0.66|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730640|NCT00551135|3186978|Superiority or Other|||||||0.8353|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730641|NCT00551135|3186978|Superiority or Other|||||||0.0967|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730642|NCT00551135|3186978|Superiority or Other|||||||0.9008|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730643|NCT00551135|3186978|Superiority or Other|||||||0.5666|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730644|NCT00551135|3186978|Superiority or Other|||||||0.0104|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730645|NCT00551135|3186978|Superiority or Other|||||||0.6143|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730646|NCT00551135|3186978|Superiority or Other|||||||0.5892|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730647|NCT00551135|3186978|Superiority or Other|||||||0.395|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730648|NCT00551135|3186978|Superiority or Other|||||||0.1497|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730649|NCT00551135|3186978|Superiority or Other|||||||0.0835|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730650|NCT00551135|3186978|Superiority or Other|||||||0.6116|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730651|NCT00551135|3186978|Superiority or Other|||||||0.3723|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730652|NCT00551135|3186978|Superiority or Other|||||||0.2912|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from coughing (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730653|NCT00551135|3186979|Superiority or Other|||||||0.755|||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730654|NCT00551135|3186979|Superiority or Other|||||||0.9869|||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730655|NCT00551135|3186979|Superiority or Other|||||||0.637|||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730656|NCT00551135|3186979|Superiority or Other|||||||0.3986|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730657|NCT00551135|3186979|Superiority or Other|||||||0.6327|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730658|NCT00551135|3186979|Superiority or Other|||||||0.873|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730659|NCT00551135|3186979|Superiority or Other|||||||0.8339|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730660|NCT00551135|3186979|Superiority or Other|||||||0.9834|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730661|NCT00551135|3186979|Superiority or Other|||||||0.5609|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730662|NCT00551135|3186979|Superiority or Other|||||||0.4798|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730663|NCT00551135|3186979|Superiority or Other|||||||0.6907|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730664|NCT00551135|3186979|Superiority or Other|||||||0.2689|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730665|NCT00551135|3186979|Superiority or Other|||||||0.6743|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730666|NCT00551135|3186979|Superiority or Other|||||||0.9884|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730667|NCT00551135|3186979|Superiority or Other|||||||0.958|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730668|NCT00551135|3186979|Superiority or Other|||||||0.5849|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730669|NCT00551135|3186979|Superiority or Other|||||||0.7717|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730670|NCT00551135|3186979|Superiority or Other|||||||0.3657|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730671|NCT00551135|3186979|Superiority or Other|||||||0.066|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730672|NCT00551135|3186979|Superiority or Other|||||||0.7725|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730673|NCT00551135|3186979|Superiority or Other|||||||0.0952|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730674|NCT00551135|3186979|Superiority or Other|||||||0.2537|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730675|NCT00551135|3186979|Superiority or Other|||||||0.3787|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730676|NCT00551135|3186979|Superiority or Other|||||||0.3884|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730677|NCT00551135|3186979|Superiority or Other|||||||0.1063|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730678|NCT00551135|3186979|Superiority or Other|||||||0.4716|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730679|NCT00551135|3186979|Superiority or Other|||||||0.3815|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730680|NCT00551135|3186979|Superiority or Other|||||||0.0348|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730681|NCT00551135|3186979|Superiority or Other|||||||0.5059|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730682|NCT00551135|3186979|Superiority or Other|||||||0.2|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730770|NCT00550173|3187180|Superiority or Other||Odds Ratio (OR)|7.68|||<|0.001|2-Sided|95.0|3.19|18.48|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730683|NCT00551135|3186979|Superiority or Other|||||||0.873|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730684|NCT00551135|3186979|Superiority or Other|||||||0.477|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730685|NCT00551135|3186979|Superiority or Other|||||||0.7992|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730686|NCT00551135|3186979|Superiority or Other|||||||0.6034|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730687|NCT00551135|3186979|Superiority or Other|||||||0.1934|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730688|NCT00551135|3186979|Superiority or Other|||||||0.6896|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from walking (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730689|NCT00551135|3186980|Superiority or Other|||||||0.7579|||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730690|NCT00551135|3186980|Superiority or Other|||||||0.7662|||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730691|NCT00551135|3186980|Superiority or Other|||||||0.2152|||||||ANOVA|||EOT; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730692|NCT00551135|3186980|Superiority or Other|||||||0.2088|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730693|NCT00551135|3186980|Superiority or Other|||||||0.8994|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730694|NCT00551135|3186980|Superiority or Other|||||||0.9241|||||||ANOVA|||Day 7 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730695|NCT00551135|3186980|Superiority or Other|||||||0.775|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730696|NCT00551135|3186980|Superiority or Other|||||||0.4566|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730697|NCT00551135|3186980|Superiority or Other|||||||0.715|||||||ANOVA|||Day 6 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730698|NCT00551135|3186980|Superiority or Other|||||||0.7951|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730699|NCT00551135|3186980|Superiority or Other|||||||0.529|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730700|NCT00551135|3186980|Superiority or Other|||||||0.3053|||||||ANOVA|||Day 5 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730701|NCT00551135|3186980|Superiority or Other|||||||0.7329|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730702|NCT00551135|3186980|Superiority or Other|||||||0.7552|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730703|NCT00551135|3186980|Superiority or Other|||||||0.8624|||||||ANOVA|||Day 4 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730704|NCT00551135|3186980|Superiority or Other|||||||0.4245|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730705|NCT00551135|3186980|Superiority or Other|||||||0.5244|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730706|NCT00551135|3186980|Superiority or Other|||||||0.707|||||||ANOVA|||Day 3 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730707|NCT00551135|3186980|Superiority or Other|||||||0.3386|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730708|NCT00551135|3186980|Superiority or Other|||||||0.8549|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730709|NCT00551135|3186980|Superiority or Other|||||||0.6017|||||||ANOVA|||Day 2 PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730710|NCT00551135|3186980|Superiority or Other|||||||0.2904|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730711|NCT00551135|3186980|Superiority or Other|||||||0.5615|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730712|NCT00551135|3186980|Superiority or Other|||||||0.1025|||||||ANOVA|||3 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730713|NCT00551135|3186980|Superiority or Other|||||||0.1641|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730714|NCT00551135|3186980|Superiority or Other|||||||0.4845|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730715|NCT00551135|3186980|Superiority or Other|||||||0.4639|||||||ANOVA|||2 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730716|NCT00551135|3186980|Superiority or Other|||||||0.0018|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730717|NCT00551135|3186980|Superiority or Other|||||||0.9902|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730718|NCT00551135|3186980|Superiority or Other|||||||0.0709|||||||ANOVA|||1 h PS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730719|NCT00551135|3186980|Superiority or Other|||||||0.2398|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730720|NCT00551135|3186980|Superiority or Other|||||||0.0197|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730721|NCT00551135|3186980|Superiority or Other|||||||0.0571|||||||ANOVA|||2 h BS; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730722|NCT00551135|3186980|Superiority or Other|||||||0.7556|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730723|NCT00551135|3186980|Superiority or Other|||||||0.7248|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730724|NCT00551135|3186980|Superiority or Other|||||||0.4471|||||||ANOVA|||Baseline; LS Means from ANOVA model with terms of treatment, pooled center and baseline pain from sitting (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730725|NCT00551135|3186981|Superiority or Other|||||||0.6932||||||Unadjusted (raw) p-value.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730771|NCT00550173|3187180|Superiority or Other||Odds Ratio (OR)|2.09|||<|0.031|2-Sided|95.0|1.07|4.09|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730726|NCT00551135|3186981|Superiority or Other|||||||0.8003||||||Unadjusted (raw) p-value.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730727|NCT00551135|3186981|Superiority or Other|||||||0.8003||||||Hochberg's adjustment applied to p-value; Hochberg's adjusted p-value was the primary analysis.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730728|NCT00551135|3186981|Superiority or Other|||||||0.0334||||||Unadjusted (raw) p-value.|ANOVA|||LS (least squares) means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730729|NCT00551135|3186981|Superiority or Other|||||||0.0668||||||Hochberg's adjustment applied to p-value; Hochberg's adjusted p-value was the primary analysis.|ANOVA|||LS Means from ANOVA model with terms of treatment, pooled center and baseline worst pain (for baseline visit ANOVA model with terms of treatment and pooled center). Centers with fewer than 8 treated subjects were combined into pooled centers.|
1730730|NCT00550953|3187000|Superiority or Other||Mean Difference (Final Values)|8.02|Standard Error of the Mean|0.82|<|0.0001|2-Sided|95.0|6.41|9.63|||ANCOVA||Difference calculated as telmisartan 40 mg plus amlodipine 5 mg fixed-dose combination minus telmisartan 40 mg monotherapy||
1730731|NCT00550862|3187002|Superiority or Other||||||<|0.0005|||||||Wilcoxon (Mann-Whitney)||||
1730732|NCT00550862|3187003|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1730733|NCT00550862|3187004|Superiority or Other||||||<|0.0001||||||Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size estimated.|Wilcoxon (Mann-Whitney)|Hierarchical model applied for multiple arms. Pairwise comparisons of the 50mg treatment group vs. the placebo group, then 25 mg, 10 mg will be done.||Endpoints will be analysed by descriptive methods. All tests:two-sided significance level of 5% will be applied unless noted. Initial Phase 2 study: no a priori estimate of treatment effect available. Effect size of 0.7003 is considered clinically meaningful. Assuming type-I error of 5%, 35 pts/arm will result in 80% power to detect effect size of 0.7003. Ests. using a 70% power calculation demonstrate cohort size of 35 pts/arm will result in 70% power to detect effect size 0.6210.|
1730734|NCT00550836|3187006|Other|||||||0.36|||||||Log Rank||||
1730735|NCT00550836|3187007|Superiority|||||||0.419|||||||Log Rank||||
1730736|NCT00550836|3187008|Other|||||||1|||||||Fisher Exact||||
1730737|NCT00550836|3187009|Superiority|||||||0.36|||||||Log Rank|||It was calculated that 39 participants randomized in a 1:1 fashion between the 2 arms would have 80% to detect a difference in median survival of 6 vs. 9.7 months for GE vs. PGE respectively with a minimum follow up of 6 months. Sample size was determined using a 1-sided log-rank test at alpha=0.20.|
1730738|NCT00550745|3187014|Superiority or Other||Risk Ratio (RR)|1.13||||||95.0|0.98|1.32|||||Relative risk (ZOSTAVAX™/placebo) of proportion of subjects reporting ≥ 1 serious AE through 6 months postvaccination and 95% Confidence Interval were based on Miettinen and Nurminen [Comparative analysis of two rates. Stat Med 1985;4:213-26] method.||
1730739|NCT00550745|3187015|Superiority or Other||Risk Ratio (RR)|1.26||||||95.0|0.91|1.73|||||Relative risk (ZOSTAVAX™/placebo) of proportion of subjects reporting ≥ 1 serious AE through 42 Days postvaccination and 95% Confidence Interval were based on Miettinen and Nurminen [Comparative analysis of two rates. Stat Med 1985;4:213-26] method.||
1730740|NCT00550550|3187047|Superiority or Other||Mean Difference (Final Values)|-0.32|||=|0|2-Sided|95.0|-0.6|-0.03|||ANOVA|Asthma status, treatment group, and site were fixed effects.|||
1730741|NCT00550550|3187048|Superiority or Other||Mean Difference (Final Values)|-0.42|||=|0|2-Sided|95.0|-0.88|0.03|||ANOVA|Asthma status, treatment group, and site were fixed effects.|||
1730742|NCT00550550|3187049|Superiority or Other||Mean Difference (Final Values)|-1.2|||=|0|2-Sided|95.0|-1.95|-0.45|||ANOVA|Asthma status, treatment group, and site were fixed effects.|||
1730743|NCT00550550|3187050|Superiority or Other||Mean Difference (Final Values)|-1.63|||=|0|2-Sided|95.0|-2.6|-0.66|||ANOVA|Asthma status, treatment group, and site were fixed effects.|||
1730744|NCT00550459|3187082|Superiority or Other||Mean Difference (Net)|4.75|Standard Deviation|3.45|<|0.0001|2-Sided|95.0|2.89|6.6||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.|
1730745|NCT00550459|3187083|Superiority or Other||Mean Difference (Net)|-0.83|Standard Deviation|3.51||0.18|2-Sided|95.0|-2.04|0.38||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.|
1730746|NCT00550459|3187084|Superiority or Other||Median Difference (Final Values)|-1.51|Standard Deviation|3.53||0.23|2-Sided|95.0|-4.02|1.0||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.|
1730772|NCT00550173|3187180|Superiority or Other||||||<|0.001|||||||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730895|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.13|0.44||||||Day 9 analyses|
1730747|NCT00550459|3187085|Superiority or Other||Mean Difference (Net)|0.12|Standard Deviation|0.39||0.16|2-Sided|95.0|-0.05|0.3||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.|
1730748|NCT00550459|3187086|Superiority or Other||Mean Difference (Net)|0.26|Standard Deviation|0.83||0.21|2-Sided|95.0|-0.15|0.67||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.|
1730749|NCT00550459|3187087|Superiority or Other||Median Difference (Net)|0.27|Standard Deviation|0.41||0.02|2-Sided|95.0|0.04|0.51||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.|
1730750|NCT00550459|3187088|Superiority or Other||Mean Difference (Net)|0.2|Standard Deviation|0.63||0.21|2-Sided|95.0|-0.12|0.51||ANCOVA with factors of treatment, disease severity, age, and severity by age interaction, and baseline as covariate. The estimated treatment and its 95% CI were provided under the model along with the p-value.|ANCOVA|||Per-protocol, secondary endpoints were ordered in 5 tiers and were to be analyzed only when at least 1 of the endpoints in the previous tier was significant. As the primary endpoint was not statistically significant, the analyses of subsequent secondary endpoint tiers are presented for exploratory purposes only.|
1730751|NCT00550459|3187089|Superiority or Other||Mean Difference (Net)|0.23|Standard Deviation|0.55||0.08|2-Sided|95.0|-0.03|0.5||Secondary endpoints were ordered in 5 tiers to be analyzed only when >=1 of the endpoints in the prior tier were significant. Since primary endpoint not stat significant, analyses of secondary endpoint tiers presented for exploratory purposes only|ANCOVA|ANCOVA with factors of treatment, disease severity, age(6 Degrees of Freedom), and covariate baseline to fit primary endpoint using the ITT dataset.||Analysis of covariance (ANCOVA) with factors of treatment,disease severity (<130mEq/L [mmol/L] or ≥130mEq/L [mmol/L] at baseline),age (<65, ≥65 to <75,and ≥75 years) (factor with 6 Degrees of Freedom), and covariate baseline used to fit primary endpoint using the intent-to-treat (ITT) dataset. Estimated treatment effect and its 95% confidence interval (CI) provided under the model with p-value. A 2-sided alpha (0.05) applied to the primary analysis. Primary analysis based on observed cases (OC).|
1730752|NCT00550407|3187162|Superiority or Other|||||||0.01|||||||Log Rank||||
1730753|NCT00550173|3187175|Superiority or Other||Hazard Ratio (HR)|1.9||||0.128|2-Sided|95.0|0.83|4.36|||Regression, Cox||||
1730754|NCT00550173|3187175|Superiority or Other||Hazard Ratio (HR)|0.32||||0.011|2-Sided|95.0|0.14|0.78|||Regression, Cox||||
1730755|NCT00550173|3187175|Superiority or Other||Hazard Ratio (HR)|0.62||||0.241|2-Sided|95.0|0.27|1.38|||Regression, Cox||||
1730756|NCT00550173|3187175|Superiority or Other|||||||0.04|||||||Regression, Cox||||
1730757|NCT00550173|3187176|Superiority or Other||Hazard Ratio (HR)|0.64||||0.023|2-Sided|95.0|0.44|0.94|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730758|NCT00550173|3187176|Superiority or Other||Hazard Ratio (HR)|0.92||||0.7|2-Sided|95.0|0.62|1.38|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730759|NCT00550173|3187176|Superiority or Other||Hazard Ratio (HR)|0.59||||0.007|2-Sided|95.0|0.41|0.87||Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730760|NCT00550173|3187176|Superiority or Other|||||||0.013|||||||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730761|NCT00550173|3187177|Superiority or Other||Odds Ratio (OR)|1.18||||0.599|2-Sided|95.0|0.63|2.22|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730762|NCT00550173|3187177|Superiority or Other||Odds Ratio (OR)|1.4||||0.318|2-Sided|95.0|0.72|2.71|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730763|NCT00550173|3187177|Superiority or Other||Odds Ratio (OR)|1.66||||0.127|2-Sided|95.0|0.87|3.18|||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730764|NCT00550173|3187177|Superiority or Other|||||||0.306|||||||Regression, Logistic|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730765|NCT00550173|3187179|Superiority or Other||Hazard Ratio (HR)|1.44||||0.094|2-Sided|95.0|0.94|2.21|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730766|NCT00550173|3187179|Superiority or Other||Hazard Ratio (HR)|0.75||||0.168|2-Sided|95.0|0.49|1.13|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730767|NCT00550173|3187179|Superiority or Other||Hazard Ratio (HR)|1.08||||0.747|2-Sided|95.0|0.69|1.67|||Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.|||
1730773|NCT00550173|3187181|Superiority or Other||Hazard Ratio, log|0.99||||0.959|2-Sided|95.0|0.7|1.4||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Secondary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.|
1730774|NCT00550173|3187181|Superiority or Other||Hazard Ratio (HR)|0.58||||0.005|2-Sided|95.0|0.39|0.85||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Primary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.|
1730775|NCT00550173|3187181|Superiority or Other||Hazard Ratio (HR)|0.57||||0.002|2-Sided|95.0|0.4|0.81||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Primary Analysis; Global null hypothesis was rejected at 2-sided 0.2 significance level.|
1730776|NCT00550173|3187181|Superiority or Other|||||||0.003||||||If global test across 3 arms is significant at a 2-sided 0.2 level, then conduct 2-sided pairwise tests between combination and each single agent under the global model. Significance is claimed only if both the global and pairwise tests p<0.05.|Regression, Cox|Model is adjusted to covariates ECOG PS (0/1 vs.2), histological subtype (adeno vs. non-adeno), race (East Asian and non-East Asian) and gender.||Overall; Global null hypothesis was rejected at 2-sided 0.2 significance level.|
1730777|NCT00550147|3187182|Superiority or Other||Mean Difference (Final Values)|-13.29|Standard Error of the Mean|2.16|<|0.05||95.0|-17.76|-8.82|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.|
1730778|NCT00550147|3187183|Superiority or Other||Mean Difference (Final Values)|-4.17|Standard Error of the Mean|1.39|<|0.05|2-Sided|95.0|-7.04|-1.29|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.|
1730779|NCT00550147|3187184|Superiority or Other||Mean Difference (Final Values)|-47.3|Standard Error of the Mean|13.06|<|0.05||95.0|-74.3|-20.2|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.|
1730780|NCT00550147|3187185|Superiority or Other||Mean Difference (Final Values)|-1.33|Standard Error of the Mean|0.2056|<|0.05||95.0|-1.75|-0.91|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. Results reported here are for the augmentation period (Visit 5-10). See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.|
1730781|NCT00550147|3187186|Superiority or Other||Mean Difference (Final Values)|-1.125|Standard Error of the Mean|0.1933|<|0.05|2-Sided|95.0|-1.52|-0.72|||t-test, 2 sided|Paired t-test (comparing augmentation period start score with end score), 23 df. Value is Visit 10 score minus Visit 5 score (null hypothesis=0).|This was a comparison of pre-post change in a single group, with treatment administered open-label.|This was a repeated-measures analysis, using a single group of subjects who were administered quetiapine in addition to OROS mph. See Kronenberger et al. (2007, Journal of Child and Adolescent Psychopharmacology) for additional information.|
1730782|NCT00549939|3187198|Superiority or Other|||||||0.7889||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA||||
1730783|NCT00549939|3187198|Superiority or Other|||||||0.7889||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor compliance was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor compliance as covariate."|
1730784|NCT00549939|3187200|Superiority or Other||LS Mean difference versus Placebo|-14.3|Standard Error of the Mean|7.48||0.1152|2-Sided|95.0|-29.1|0.47||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA||||
1730813|NCT00549549|3187280|Superiority or Other|||||||0.0845|||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730855|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.13|||2-Sided|95.0|0.03|0.55||||||Day 1, 12 hours postdose|
1730785|NCT00549939|3187200|Superiority or Other||LS Mean difference versus Placebo|-11.4|Standard Error of the Mean|7.54||0.1338|2-Sided|95.0|-26.27|3.53||P-values was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor LPP as covariate."|
1730786|NCT00549939|3187201|Superiority or Other||LS Mean difference versus Placebo|-7.1|Standard Error of the Mean|3.77||0.104|2-Sided|95.0|-14.51|0.39||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA||||
1730787|NCT00549939|3187201|Superiority or Other||LS Mean difference versus Placebo|-6.2|Standard Error of the Mean|3.8||0.104|2-Sided|95.0|-13.72|1.29||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|ANCOVA|||"Change in detrusor LPP was analyzed using a three-way analysis of covariance (ANCOVA) including 3 variables as fixed effects:~treatment group (alfuzosin 0.1 mg/kg/day, alfuzosin 0.2 mg/kg/day or placebo),~age/formulation group (2-7 years of age on solution, 8-16 years of age on solution or 8-16 years of age on tablets),~anticholinergic/antimuscarinic use (yes or no),~and using centered baseline detrusor LPP as covariate."|
1730788|NCT00549939|3187203|Superiority or Other|||||||0.91||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|Fisher Exact||||
1730789|NCT00549939|3187203|Superiority or Other|||||||1||||||P-value was adjusted for multiplicity using the Hochberg procedure. The a priori threshold for statistical significance was 0.05.|Fisher Exact||||
1730790|NCT00549718|3187261|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis||||
1730791|NCT00549718|3187262|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis||||
1730792|NCT00549640|3187263|Superiority or Other|||||||0.79|||||||Mixed Models Analysis|analysis performed using daily scores|||
1730793|NCT00549640|3187263|Superiority or Other|||||||0.65|||||||t-test, 2 sided|For each subject, the average daily withdrawal score for the 14 days following target quit date was calculated and expressed as a change from baseline|||
1730794|NCT00549640|3187264|Superiority or Other|||||||0.5|||||||Fisher Exact|1 tailed test|||
1730795|NCT00549640|3187265|Superiority or Other|||||||0.973|||||||Fisher Exact|1-tailed|||
1730796|NCT00549549|3187277|Superiority or Other|||||||0.7316|||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1; >1], and region.|
1730797|NCT00549549|3187277|Superiority or Other|||||||0.7316|||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1; >1], and region.|
1730798|NCT00549549|3187277|Superiority or Other|||||||0.4724|||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1; >1], and region.|
1730799|NCT00549549|3187278|Superiority or Other|||||||0.3173|||||||Cochran-Mantel-Haenszel|||p-value calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1; >1], and region.|
1730800|NCT00549549|3187279|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.28|0.19|||||||
1730801|NCT00549549|3187279|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.43|0.05|||||||
1730802|NCT00549549|3187279|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.5|-0.02|||||||
1730803|NCT00549549|3187279|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.02|0.46|||||||
1730804|NCT00549549|3187279|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.17|0.31||||||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient’s Assessment of Pain Intensity at Baseline as a covariate.|
1730805|NCT00549549|3187280|Superiority or Other|||||||0.7956|||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730806|NCT00549549|3187280|Superiority or Other|||||||0.1592|||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730807|NCT00549549|3187280|Superiority or Other|||||||0.0317|||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730808|NCT00549549|3187280|Superiority or Other|||||||0.0818|||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730809|NCT00549549|3187280|Superiority or Other|||||||0.5378|||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during study. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730810|NCT00549549|3187280|Superiority or Other|||||||0.6636|||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730811|NCT00549549|3187280|Superiority or Other|||||||0.1231|||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730812|NCT00549549|3187280|Superiority or Other|||||||0.0213|||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1734748|NCT00506675|3193985|Superiority or Other|||||||0.3|||||||ANCOVA||||
1730814|NCT00549549|3187280|Superiority or Other|||||||0.5005|||||||Cochran-Mantel-Haenszel|||Withdrawal on any time during treatment. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730815|NCT00549549|3187280|Superiority or Other|||||||0.3384|||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730816|NCT00549549|3187280|Superiority or Other|||||||0.1754|||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730817|NCT00549549|3187280|Superiority or Other|||||||0.1779|||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730818|NCT00549549|3187280|Superiority or Other|||||||0.5528|||||||Cochran-Mantel-Haenszel|||Withdrawal on Day 1. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730819|NCT00549549|3187283|Superiority or Other|||||||0.4603|||||||Cochran-Mantel-Haenszel|||>=50% reduction analyses|
1730820|NCT00549549|3187283|Superiority or Other|||||||0.0394|||||||Cochran-Mantel-Haenszel|||>=50% reduction analyses|
1730821|NCT00549549|3187283|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||>=50% reduction analyses|
1730822|NCT00549549|3187283|Superiority or Other||||||<|0.0018|||||||Cochran-Mantel-Haenszel|||>=50% reduction analyses|
1730823|NCT00549549|3187283|Superiority or Other||||||<|0.0277|||||||Cochran-Mantel-Haenszel|||>=50% reduction analyses|
1730824|NCT00549549|3187283|Superiority or Other||||||<|0.5592|||||||Cochran-Mantel-Haenszel|||>=30% reduction analyses|
1730825|NCT00549549|3187283|Superiority or Other||||||<|0.041|||||||Cochran-Mantel-Haenszel|||>=30% reduction analyses|
1730826|NCT00549549|3187283|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||>=30% reduction analyses|
1730827|NCT00549549|3187283|Superiority or Other||||||<|0.0017|||||||Cochran-Mantel-Haenszel|||>=30% reduction analyses|
1730828|NCT00549549|3187283|Superiority or Other||||||<|0.0459|||||||Cochran-Mantel-Haenszel|||>=30% reduction analyses. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient’s Assessment of Pain Intensity at Baseline as a covariate.|
1730829|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.32|0.11||||||24 hour postdose analysis|
1730830|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.47|-0.05||||||24 hour postdose analysis|
1730831|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.61|-0.18||||||24 hour postdose analysis|
1730832|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.11|||2-Sided|95.0|0.08|0.51||||||24 hour postdose analysis|
1730833|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.08|0.35||||||24 hour postdose analysis|
1730834|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1|||2-Sided|95.0|-0.29|0.09||||||12 hour postdose analysis|
1730835|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.1|||2-Sided|95.0|-0.45|-0.07||||||12 hour postdose analysis|
1730836|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|0.1|||2-Sided|95.0|-0.55|-0.16||||||12 hour postdose analysis|
1730837|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|0.26|Standard Error of the Mean|0.1|||2-Sided|95.0|0.06|0.45||||||12 hour postdose analysis|
1730838|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.1|||2-Sided|95.0|-0.1|0.29||||||12 hour postdose analysis|
1730839|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.09|||2-Sided|95.0|-0.28|0.08||||||8 hour postdose analysis|
1730840|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.09|||2-Sided|95.0|-0.41|-0.05||||||8 hour postdose analysis|
1730841|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.09|||2-Sided|95.0|-0.5|-0.14||||||8 hour postdose analysis|
1730842|NCT00549549|3187284|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.09|||2-Sided|95.0|0.04|0.4||||||8 hour postdose analysis|
1730843|NCT00549549|3187284|Superiority or Other||Median Difference (Final Values)|0.09|Standard Error of the Mean|0.09|||2-Sided|95.0|-0.09|0.27||||||8 hour postdose analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient’s Assessment of Pain Intensity at Baseline as a covariate.|
1730844|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.11|0.42||||||Day 2, 8 hours postdose|
1730845|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.34|Standard Error of the Mean|0.13|||2-Sided|95.0|0.08|0.61||||||Day 2, 8 hours postdose|
1730846|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.47|Standard Error of the Mean|0.14|||2-Sided|95.0|0.2|0.74||||||Day 2, 8 hours postdose|
1730847|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.59|-0.05||||||Day 2, 8 hours postdose|
1730848|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.4|0.14||||||Day 2, 8 hours postdose|
1730849|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.15|0.38||||||Day 2, 0 hours postdose|
1730850|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.04|0.49||||||Day 2, 0 hours postdose|
1731485|NCT00543569|3188241|Superiority or Other||Difference|-1.6|||||2-Sided|90.0|-10.6|7.4||||||Graft survival at 12 months|
1730856|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.45|Standard Error of the Mean|0.13|||2-Sided|95.0|0.19|0.7||||||Day 1, 12 hours postdose|
1730857|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.63|-0.11||||||Day 1, 12 hours postdose|
1730858|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.42|0.1||||||Day 1, 12 hours postdose|
1730859|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.13|0.36||||||Day 1, 8 hours postdose|
1730860|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.35|Standard Error of the Mean|0.12|||2-Sided|95.0|0.11|0.59||||||Day 1, 8 hours postdose|
1730861|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.42|Standard Error of the Mean|0.12|||2-Sided|95.0|0.18|0.67||||||Day 1, 8 hours postdose|
1730862|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.56|-0.06||||||Day 1, 8 hours postdose|
1730863|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.32|0.17||||||Day 1, 8 hours postdose|
1730864|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.11|0.34||||||Day 1, 4 hours postdose|
1730865|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.11|||2-Sided|95.0|0.0|0.44||||||Day 1, 4 hours postdose|
1730866|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.36|Standard Error of the Mean|0.11|||2-Sided|95.0|0.14|0.58||||||Day 1, 4 hours postdose|
1730867|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.48|-0.03||||||Day 1, 4 hours postdose|
1730868|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.37|0.08||||||Day 1, 4 hours postdose|
1730869|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.08|0.34||||||Day 1, 2 hours postdose|
1730870|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.1|||2-Sided|95.0|0.04|0.45||||||Day 1, 2 hours postdose|
1730871|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|0.31|Standard Error of the Mean|0.1|||2-Sided|95.0|0.11|0.52||||||Day 1, 2 hours postdose|
1730872|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|-0.18|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.39|0.03||||||Day 1, 2 hours postdose|
1730873|NCT00549549|3187285|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.28|0.14||||||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient’s Assessment of Pain Intensity at Baseline as a covariate.|
1730874|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.6|0.01||||||Day 13/Early Termination analyses|
1730875|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.35|0.26||||||Day 13/Early Termination analyses|
1730876|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.1|0.51||||||Day 13/Early Termination analyses|
1730877|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.81|-0.19||||||Day 13/Early Termination analyses|
1730878|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.56|0.07||||||Day 13/Early Termination analyses|
1730879|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.5|0.11||||||Day 12 analyses|
1730880|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.25|0.36||||||Day 12 analyses|
1730881|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.27|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.04|0.57||||||Day 12 analyses|
1730882|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.77|-0.15||||||Day 12 analyses|
1730883|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.16|||2-Sided|95.0|-0.53|0.09||||||Day 12 analyses|
1730884|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.37|0.23||||||Day 11 analyses|
1730885|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.16|0.44||||||Day 11 analyses|
1730886|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.15|||2-Sided|95.0|0.1|0.69||||||Day 11 analyses|
1730887|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.77|-0.17||||||Day 11 analyses|
1730888|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.56|0.05||||||Day 11 analyses|
1730889|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.36|0.23||||||Day 10 analyses|
1730890|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.18|0.41||||||Day 10 analyses|
1730891|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.15|||2-Sided|95.0|0.1|0.69||||||Day 10 analyses|
1730892|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.76|-0.16||||||Day 10 analyses|
1730893|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.59|0.01||||||Day 10 analyses|
1730894|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.35|0.23||||||Day 9 analyses|
1730896|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.47|Standard Error of the Mean|0.15|||2-Sided|95.0|0.18|0.76||||||Day 9 analyses|
1730897|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.82|-0.23||||||Day 9 analyses|
1730898|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.61|-0.02||||||Day 9 analyses|
1730899|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.42|0.14||||||Day 8 analyses|
1730900|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.15|0.41||||||Day 8 analyses|
1730901|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.42|Standard Error of the Mean|0.14|||2-Sided|95.0|0.14|0.7||||||Day 8 analyses|
1730902|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.55|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.84|-0.27||||||Day 8 analyses|
1730903|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.57|0.0||||||Day 8 analyses|
1730904|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.42|0.15||||||Day 7 analyses|
1730905|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.11|0.45||||||Day 7 analyses|
1730906|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.49|Standard Error of the Mean|0.14|||2-Sided|95.0|0.21|0.78||||||Day 7 analyses|
1730907|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.63|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.92|-0.34||||||Day 7 analyses|
1730908|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.15|||2-Sided|95.0|-0.61|-0.04||||||Day 7 analyses|
1730909|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.28|0.26||||||Day 6 analyses|
1730910|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.08|0.46||||||Day 6 analyses|
1730911|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.56|Standard Error of the Mean|0.14|||2-Sided|95.0|0.29|0.83||||||Day 6 analyses|
1730912|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.57|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.84|-0.29||||||Day 6 analyses|
1730913|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.65|-0.1||||||Day 6 analyses|
1730914|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.29|0.27||||||Day 5 analyses|
1730915|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.14|||2-Sided|95.0|0.02|0.57||||||Day 5 analyses|
1730916|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.65|Standard Error of the Mean|0.14|||2-Sided|95.0|0.37|0.93||||||Day 5 analyses|
1730917|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.66|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.94|-0.38||||||Day 5 analyses|
1730918|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.64|-0.07||||||Day 5 analyses|
1730919|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.21|0.34||||||Day 4 analyses|
1730920|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.34|Standard Error of the Mean|0.14|||2-Sided|95.0|0.07|0.62||||||Day 4 analyses|
1730921|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.62|Standard Error of the Mean|0.14|||2-Sided|95.0|0.35|0.9||||||Day 4 analyses|
1730922|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.56|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.84|-0.28||||||Day 4 analyses|
1730923|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.56|0.0||||||Day 4 analyses|
1730924|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.22|0.34||||||Day 3 analyses|
1730925|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.36|Standard Error of the Mean|0.14|||2-Sided|95.0|0.08|0.64||||||Day 3 analyses|
1730926|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.14|||2-Sided|95.0|0.32|0.88||||||Day 3 analyses|
1730927|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.55|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.83|-0.26||||||Day 3 analyses|
1730928|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.53|0.03||||||Day 3 analyses|
1730929|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.17|0.39||||||Day 2 analyses|
1730930|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.14|||2-Sided|95.0|0.05|0.6||||||Day 2 analyses|
1730931|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.57|Standard Error of the Mean|0.14|||2-Sided|95.0|0.29|0.84||||||Day 2 analyses|
1730932|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.74|-0.18||||||Day 2 analyses|
1730933|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.52|0.04||||||Day 2 analyses|
1730934|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.21|0.28||||||Day 1 analyses|
1730935|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.06|0.44||||||Day 1 analyses|
1730936|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|0.54|Standard Error of the Mean|0.13|||2-Sided|95.0|0.29|0.78||||||Day 1 analyses|
1734749|NCT00506675|3193986|Superiority or Other|||||||0.3|||||||ANCOVA||||
1730937|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.75|-0.25||||||Day 1 analyses|
1730938|NCT00549549|3187286|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.6|-0.1||||||The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular), region and treatment group as factors, and the Patient’s Assessment of Pain Intensity at Baseline as a covariate.|
1730939|NCT00549549|3187287|Superiority or Other|||||||0.5687|||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses|
1730940|NCT00549549|3187287|Superiority or Other|||||||0.0787|||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses|
1730941|NCT00549549|3187287|Superiority or Other|||||||0.369|||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses|
1730942|NCT00549549|3187287|Superiority or Other|||||||0.1353|||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses|
1730943|NCT00549549|3187287|Superiority or Other|||||||0.0169|||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses|
1730944|NCT00549549|3187287|Superiority or Other|||||||0.7855|||||||Cochran-Mantel-Haenszel|||Day 9 analyses|
1730945|NCT00549549|3187287|Superiority or Other|||||||0.4986|||||||Cochran-Mantel-Haenszel|||Day 9 analyses|
1730946|NCT00549549|3187287|Superiority or Other|||||||0.5703|||||||Cochran-Mantel-Haenszel|||Day 9 analyses|
1730947|NCT00549549|3187287|Superiority or Other|||||||0.4356|||||||Cochran-Mantel-Haenszel|||Day 9 analyses|
1730948|NCT00549549|3187287|Superiority or Other|||||||0.3098|||||||Cochran-Mantel-Haenszel|||Day 9 analyses|
1730949|NCT00549549|3187287|Superiority or Other|||||||0.6717|||||||Cochran-Mantel-Haenszel|||Day 5 analyses|
1730950|NCT00549549|3187287|Superiority or Other|||||||0.3878|||||||Cochran-Mantel-Haenszel|||Day 5 analyses|
1730951|NCT00549549|3187287|Superiority or Other|||||||0.4722|||||||Cochran-Mantel-Haenszel|||Day 5 analyses|
1730952|NCT00549549|3187287|Superiority or Other|||||||0.7532|||||||Cochran-Mantel-Haenszel|||Day 5 analyses|
1730953|NCT00549549|3187287|Superiority or Other|||||||0.1444|||||||Cochran-Mantel-Haenszel|||Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730954|NCT00549549|3187288|Superiority or Other|||||||0.2556|||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analysis|
1730955|NCT00549549|3187288|Superiority or Other|||||||0.6204|||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses|
1730956|NCT00549549|3187288|Superiority or Other|||||||0.5747|||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses|
1730957|NCT00549549|3187288|Superiority or Other|||||||0.0831|||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses|
1730958|NCT00549549|3187288|Superiority or Other|||||||0.9317|||||||Cochran-Mantel-Haenszel|||Day 14/Early Termination analyses|
1730959|NCT00549549|3187288|Superiority or Other|||||||0.5981|||||||Cochran-Mantel-Haenszel|||Day 9 analyses|
1730960|NCT00549549|3187288|Superiority or Other|||||||0.411|||||||Cochran-Mantel-Haenszel|||Day 9 analyses|
1730961|NCT00549549|3187288|Superiority or Other|||||||0.6892|||||||Cochran-Mantel-Haenszel|||Day 9 analyses|
1730962|NCT00549549|3187288|Superiority or Other|||||||0.8364|||||||Cochran-Mantel-Haenszel|||Day 9 analyses|
1730963|NCT00549549|3187288|Superiority or Other|||||||0.4957|||||||Cochran-Mantel-Haenszel|||Day 9 analyses|
1730964|NCT00549549|3187288|Superiority or Other|||||||0.4951|||||||Cochran-Mantel-Haenszel|||Day 5 analyses|
1730965|NCT00549549|3187288|Superiority or Other|||||||0.2962|||||||Cochran-Mantel-Haenszel|||Day 5 analyses|
1730966|NCT00549549|3187288|Superiority or Other|||||||0.4581|||||||Cochran-Mantel-Haenszel|||Day 5 analyses|
1730967|NCT00549549|3187288|Superiority or Other|||||||0.9739|||||||Cochran-Mantel-Haenszel|||Day 5 analyses|
1730968|NCT00549549|3187288|Superiority or Other|||||||0.6402|||||||Cochran-Mantel-Haenszel|||Day 5 analyses. Pairwise p-values are presented, calculated using Cochran-Mantel-Haenszel statistics, stratified by number of affected joints [1 or >1]) and region.|
1730969|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.36|0.12||||||Day 14/early termination analysis|
1730970|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.22|0.26||||||Day 14/early termination analysis|
1730971|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.08|0.39||||||Day 14/early termination analysis|
1730972|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|-0.28|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.52|-0.04||||||Day 14/early termination analysis|
1730973|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.38|0.1||||||Day 14/early termination analysis|
1730974|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.22|0.26||||||Day 9 analysis.|
1730975|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.14|0.33||||||Day 9 analysis.|
1730976|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.01|0.46||||||Day 9 analysis.|
1730977|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.44|0.04||||||Day 9 analysis.|
1730978|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.12|||2-Sided|95.0|-0.36|0.11||||||Day 9 analysis.|
1730979|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.26|0.25||||||Day 5 analysis.|
1730980|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.2|0.3||||||Day 5 analysis.|
1730981|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.17|0.34||||||Day 5 analysis.|
1730982|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.35|0.16||||||Day 5 analysis.|
1730983|NCT00549549|3187289|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.13|||2-Sided|95.0|-0.29|0.22||||||Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient’s Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.|
1730984|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.38|0.05||||||Day 14/early termination analysis|
1730985|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.17|0.25||||||Day 14/early termination analysis|
1730986|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.05|0.37||||||Day /early termination analysis|
1730987|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.53|-0.11||||||Day 14/early termination analysis|
1730988|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.33|0.1||||||Day 14/early termination analysis|
1730989|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.3|0.13||||||Day 9 analysis|
1730990|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.16|0.27||||||Day 9 analysis|
1730991|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.11|0.32||||||Day 9 analysis|
1730992|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.4|0.03||||||Day 9 analysis|
1730993|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.26|0.16||||||Day 9 analysis|
1730994|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.16|0.27||||||Day 5 analysis|
1730995|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.04|0.39||||||Day 5 analysis|
1730996|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|0.26|Standard Error of the Mean|0.11|||2-Sided|95.0|0.04|0.47||||||Day 5 analysis|
1730997|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.42|0.02||||||Day 5 analysis|
1730998|NCT00549549|3187290|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.11|||2-Sided|95.0|-0.29|0.14||||||Day 5 analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group as factors, and the Patient’s Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.|
1730999|NCT00549549|3187291|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.17|0.39|||||||
1731000|NCT00549549|3187291|Superiority or Other||Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.14|||2-Sided|95.0|0.05|0.6|||||||
1731001|NCT00549549|3187291|Superiority or Other||Mean Difference (Final Values)|0.57|Standard Error of the Mean|0.14|||2-Sided|95.0|0.29|0.84|||||||
1731002|NCT00549549|3187291|Superiority or Other||Median Difference (Final Values)|-0.24|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.52|0.04|||||||
1731003|NCT00549549|3187291|Superiority or Other||Median Difference (Final Values)|-0.46|Standard Error of the Mean|0.14|||2-Sided|95.0|-0.74|-0.18||||||This was the primary analysis. The analysis was conducted using analysis of covariance (ANCOVA) with randomization stratum (2 levels: monoarticular or oligoarticular) and treatment group and region as factors, and the Patient’s Assessment of Pain Intensity (for the prior 24 hours) at Baseline as a covariate.|
1731004|NCT00549445|3187292|Other|Student t test||||||0.045||||||Threshold for significance is P-Value < 0.05|t-test, 1 sided||||
1731005|NCT00549198|3187306|Superiority or Other|||||||0.0266||||||The model includes the following covariates: treatment, baseline biomarker value, and baseline CD4.|ANOVA|Estimates are calculated from an ANOVA model.|||
1731006|NCT00549198|3187307|Superiority or Other|||||||0.0019||||||The model includes the following covariates: treatment, age, baseline biomarker value, and baseline CD4.|ANOVA|Estimates are calculated from an ANOVA model.|||
1731007|NCT00549198|3187308|Superiority or Other|||||||0.0019||||||The model includes the following covariates: treatment, baseline biomarker value, and gender.|ANOVA|Estimates are calculated from an ANOVA model.|||
1731008|NCT00549198|3187309|Superiority or Other||||||<|0.0001||||||The model includes the following covariates: treatment, age, and baseline biomarker value.|ANOVA|Estimates are calculated from ana ANOVA model. Parameters are analyzed based on log transformed data.|||
1731009|NCT00549198|3187310|Superiority or Other||||||<|0.0001||||||The model includes the following covariates: treatment, baseline biomarker value, baseline CD4, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.|||
1731010|NCT00549198|3187311|Superiority or Other|||||||0.3323||||||The model includes the following covariates: treatment, age, and baseline biomarker value.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.|||
1731011|NCT00549198|3187312|Superiority or Other||||||<|0.0001||||||The model includes the following covariates: treatment, age, baseline biomarker value, baseline CD4, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.|||
1731012|NCT00549198|3187313|Superiority or Other|||||||0.3025||||||The model includes the following covariates: treatment, age, baseline biomarker value, and gender.|ANOVA|Estimates are calculated from an ANOVA model. Parameters are analyzed based on log transformed data.|||
1731013|NCT00549198|3187346|Superiority or Other||||||<|0.001||||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment*visit, baseline hip BMD*visit, and baseline BMI*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.|||
1731065|NCT00548262|3187451|Superiority or Other||percentage of participants with success|46.5|||||2-Sided|95.0|31.6|61.4|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success|
1731014|NCT00549198|3187347|Superiority or Other|||||||0.112||||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment*visit, baseline spine BMD*visit and baseline BMI*visit.|Mixed Models Analysis|correlation matrix for within-subject errors is unstructured.|||
1731015|NCT00549198|3187348|Superiority or Other||||||<|0.001||||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, prohibited medication, previous fracture, treatment*visit, baseline hip BMD*visit and baseline BMI*visit.|Mixed Models Analysis|Correlation matrix for within-subject errors is unstructured.|||
1731016|NCT00549198|3187349|Superiority or Other|||||||0.036||||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, treatment*visit, baseline spine BMD*visit and baseline BMI*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.|||
1731017|NCT00549198|3187350|Superiority or Other||||||<|0.001||||||The model includes the following covariates: treatment, visit, baseline hip BMD, baseline BMI, race group, risk factor, country group, treatment*visit, baseline hip BMD*visit and baseline BMI*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.|||
1731018|NCT00549198|3187351|Superiority or Other||||||<|0.001||||||The model includes the following covariates: treatment, visit, baseline spine BMD, baseline BMI, race group, age group, hypertension, treatment*visit, baseline spine BMD*visit and baseline BMI*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.|||
1731019|NCT00549198|3187358|Superiority or Other|||||||0.315||||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, baseline CD4, treatment*visit, baseline GFR by CG*visit, baseline BMI*visit and baseline CD4*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.|||
1731020|NCT00549198|3187359|Superiority or Other|||||||0.413||||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment*visit, baseline GFR by CG*visit and baseline BMI*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.|||
1731021|NCT00549198|3187360|Superiority or Other|||||||0.186||||||The model includes the following covariates: treatment, visit, baseline GFR by CG, baseline BMI, race group, age group, hypertension, treatment*visit, baseline GFR by CG*visit and baseline BMI*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.|||
1731022|NCT00549198|3187361|Superiority or Other|||||||0.06||||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment*visit, baseline GFR by MDRD*visit and baseline BMI*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.|||
1731023|NCT00549198|3187362|Superiority or Other|||||||0.057||||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, age group, treatment*visit, baseline GFR by MDRD*visit and baseline BMI*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.|||
1731024|NCT00549198|3187363|Superiority or Other|||||||0.435||||||The model includes the following covariates: treatment, visit, baseline GFR by MDRD, baseline BMI, race group, treatment*visit, baseline GFR by MDRD*visit and baseline BMI*visit.|Mixed Models Analysis|The correlation matrix for within-subject errors is unstructured.|||
1731025|NCT00548808|3187383|Superiority or Other||Least Squares Mean Difference|0.02|Standard Error of the Mean|0.02||0.382|2-Sided|95.0|-0.02|0.06||P-value for High Density Lipoprotein.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.||
1731026|NCT00548808|3187383|Superiority or Other||Least Squares Mean Difference|-0.05|Standard Error of the Mean|0.07||0.51|2-Sided|95.0|-0.18|0.09||P-value for Low Density Lipoprotein.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.||
1731027|NCT00548808|3187383|Superiority or Other||Least Squares Mean Difference|-0.12|Standard Error of the Mean|0.09||0.165|2-Sided|95.0|-0.3|0.05||P-value for Triglycerides.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.||
1731028|NCT00548808|3187383|Superiority or Other||Least Squares Mean Difference|-0.11|Standard Error of the Mean|0.08||0.162|2-Sided|95.0|-0.26|0.04||P-value for Cholesterol.|ANCOVA|ANCOVA model: Lab Result = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.||
1731029|NCT00548808|3187386|Superiority or Other|||||||0.582||||||P-value for 48 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment*Visit|||
1731030|NCT00548808|3187386|Superiority or Other|||||||0.814||||||P-value for Week 32 Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment*Visit|||
1731031|NCT00548808|3187386|Superiority or Other|||||||0.604||||||P-value for Week 16 Change from Baseline|Mixed Models Analysis|Mixed Model Analysis: Change in Blood Glucose = Treatment + Baseline + Country + HbA1c stratum + Sulfonylurea use + Visit + Treatment*Visit|||
1731032|NCT00548808|3187388|Superiority or Other||Odds Ratio (OR)|1.05||||0.829|2-Sided|95.0|0.67|1.64||P-value for patients achieving HbA1c <7% at 48 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit*treatment.|||
1731033|NCT00548808|3187388|Superiority or Other||Odds Ratio (OR)|1.17||||0.555|2-Sided|95.0|0.69|2.01||P-value for patients achieving HbA1c <6.5% at 48 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit*treatment.|||
1731034|NCT00548808|3187388|Superiority or Other||Odds Ratio (OR)|1.06||||0.81|2-Sided|95.0|0.68|1.64||P-value for patients achieving HbA1c <7% at 32 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit*treatment.|||
1731486|NCT00543569|3188241|Superiority or Other||Difference|-0.9|||||2-Sided|90.0|-9.9|8.1||||||Graft survival at 12 months|
1731035|NCT00548808|3187388|Superiority or Other||Odds Ratio (OR)|1.12||||0.683|2-Sided|95.0|0.65|1.95||P-value for patients achieving HbA1c <6.5% at 32 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit*treatment.|||
1731036|NCT00548808|3187388|Superiority or Other||Odds Ratio (OR)|0.81||||0.365|2-Sided|95.0|0.51|1.28||P-value for Patients Achieving HbA1c <7% at 16 Weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit*treatment.|||
1731037|NCT00548808|3187388|Superiority or Other||Odds Ratio (OR)|0.79||||0.465|2-Sided|95.0|0.41|1.5||P-value for patients achieving HbA1c <6.5% at 16 weeks.|Regression, Logistic|Generalized Estimating Equation model with fixed effects for treatment, country, sulfonylurea use, baseline HbA1c, visit, and visit*treatment.|||
1731038|NCT00548808|3187389|Superiority or Other|||||||0.741||||||P-value for 48 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment*Visit (Type 3 sums of squares).|||
1731039|NCT00548808|3187389|Superiority or Other|||||||0.846||||||P-value for 32 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment*Visit (Type 3 sums of squares).|||
1731040|NCT00548808|3187389|Superiority or Other|||||||0.279||||||P-value for 16 Week Change from Baseline.|Mixed Models Analysis|Mixed Model Analysis: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use + Visit + Treatment*Visit (Type 3 sums of squares).|||
1731041|NCT00548808|3187390|Non-Inferiority or Equivalence|A noninferiority margin of 0.4% for HbA1c was used.|Least Squares Mean Difference|-0.04|Standard Error of the Mean|0.11||0.716|2-Sided|95.0|-0.25|0.17|||ANCOVA|ANCOVA Model: Change in HbA1c = Treatment + Baseline + Country + Sulfonylurea use (Type III sums of squares).|Least Squares Mean Difference = Insulin Lispro LM minus Insulin Glargine.||
1731042|NCT00548717|3187394|Superiority or Other|||||||0.79|||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 12.|
1731043|NCT00548717|3187394|Superiority or Other|||||||0.63|||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 8.|
1731044|NCT00548717|3187394|Superiority or Other|||||||0.92|||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 3.|
1731045|NCT00548717|3187394|Superiority or Other|||||||0.59|||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 2.|
1731046|NCT00548717|3187394|Superiority or Other|||||||0.77|||||||t-test, 2 sided|||Comparison between Grade 0-I aGVHD vs Grade II-IV aGVHD in the Siro/MMF group at week 1.|
1731047|NCT00548405|3187421|Superiority or Other|||||||0.1371|||||||Ranked ANCOVA|||Ranked ANCOVA models with covariate adjustment for geographic region and Baseline T2 lesion volume was used.|
1731048|NCT00548405|3187422|Superiority or Other|||||||0.0022|||||||Wei-Lachin|||Change at Year 2: the analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.|
1731049|NCT00548405|3187423|Superiority or Other||||||<|0.0001|||||||Wei-Lachin|||The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.|
1731050|NCT00548405|3187424|Superiority or Other||Hazard Ratio (HR)|0.53|||<|0.0001|2-Sided|95.0|0.41|0.69|||Cox Proportional Hazards Regression|||Cox PH regression model with robust variance estimation and covariate adjustment for geographic region was used.|
1731051|NCT00548405|3187425|Superiority or Other||Rate ratio|0.51|||<|0.0001|2-Sided|95.0|0.39|0.65||Hochberg method was used to adjust for the two co-primary outcomes.|Proportional means regression|||Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.|
1731052|NCT00548405|3187426|Superiority or Other||Hazard Ratio (HR)|0.58||||0.0084|2-Sided|95.0|0.38|0.87||Hochberg method was used to adjust for the two co-primary outcomes.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariate was used.|
1731053|NCT00548262|3187450|Superiority or Other||percentage of participants with success|11.1|||||2-Sided|95.0|0.0|31.6|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (Week 2 F/U): Success|
1731054|NCT00548262|3187450|Superiority or Other||percentage of participants with success|57.1|||||2-Sided|95.0|40.7|73.5|||||95% CI based on normal approximation to the binomial.|APACHE <20 (Week 2 F/U): Success|
1731055|NCT00548262|3187450|Superiority or Other||percentage of participants with success|11.1|||||2-Sided|95.0|0.0|31.6|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (EOT): Success|
1731056|NCT00548262|3187450|Superiority or Other||percentage of participants with success|71.4|||||2-Sided|95.0|56.5|86.4|||||95% CI based on normal approximation to the binomial.|APACHE <20 (EOT): Success|
1731057|NCT00548262|3187450|Superiority or Other||percentage of participants with success|22.2|||||2-Sided|95.0|0.0|49.4|||||95% CI based on normal approximation to the binomial.|APACHE ≥20 (EIVT): Success|
1731058|NCT00548262|3187450|Superiority or Other||percentage of participants with success|68.6|||||2-Sided|95.0|53.2|84.0|||||95% CI based on normal approximation to the binomial.|APACHE <20 (EIVT): Success|
1731059|NCT00548262|3187451|Superiority or Other||percentage of participants with success|51.7|||||2-Sided|95.0|33.5|69.9|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success|
1731060|NCT00548262|3187451|Superiority or Other||percentage of participants with success|66.7|||||2-Sided|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success|
1731061|NCT00548262|3187451|Superiority or Other||percentage of participants with success|50.0|||||2-Sided|95.0|32.7|67.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success|
1731062|NCT00548262|3187451|Superiority or Other||percentage of participants with success|41.7|||||2-Sided|95.0|13.8|69.6|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success|
1731063|NCT00548262|3187451|Superiority or Other||percentage of participants with success|48.7|||||2-Sided|95.0|33.0|64.4|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success|
1731064|NCT00548262|3187451|Superiority or Other||percentage of participants with success|40.0|||||2-Sided|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success|
1731066|NCT00548262|3187451|Superiority or Other||percentage of participants with success|54.1|||||2-Sided|95.0|38.0|70.1|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success|
1731067|NCT00548262|3187451|Superiority or Other||percentage of participants with success|14.3|||||2-Sided|95.0|0.0|40.2|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success|
1731068|NCT00548262|3187451|Superiority or Other||percentage of participants with success|47.7|||||2-Sided|95.0|33.0|62.5|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success|
1731069|NCT00548262|3187451|Superiority or Other||percentage of participants with success|52.0|||||2-Sided|95.0|32.4|71.6|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success|
1731070|NCT00548262|3187451|Superiority or Other||percentage of participants with success|42.1|||||2-Sided|95.0|19.9|64.3|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success|
1731071|NCT00548262|3187451|Superiority or Other||percentage of participants with success|54.1|||||2-Sided|95.0|38.0|70.1|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success|
1731072|NCT00548262|3187451|Superiority or Other||percentage of participants with success|14.3|||||2-Sided|95.0|0.0|40.2|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success|
1731073|NCT00548262|3187451|Superiority or Other||percentage of participants with success|51.6|||||2-Sided|95.0|34.0|69.2|||||95% CI based on normal approximation to the binomial.|TPN (No): Success|
1731074|NCT00548262|3187451|Superiority or Other||percentage of participants with success|38.5|||||2-Sided|95.0|12.0|64.9|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success|
1731075|NCT00548262|3187451|Superiority or Other||percentage of participants with success|50.0|||||2-Sided|95.0|10.0|90.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success|
1731076|NCT00548262|3187451|Superiority or Other||percentage of participants with success|47.4|||||2-Sided|95.0|31.5|63.2|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success|
1731077|NCT00548262|3187451|Superiority or Other||percentage of participants with success|40.0|||||2-Sided|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success|
1731078|NCT00548262|3187451|Superiority or Other||percentage of participants with success|48.7|||||2-Sided|95.0|33.0|64.4|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success|
1731079|NCT00548262|3187451|Superiority or Other||percentage of participants with success|72.7|||||2-Sided|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success|
1731080|NCT00548262|3187451|Superiority or Other||percentage of participants with success|39.4|||||2-Sided|95.0|22.7|56.1|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success|
1731081|NCT00548262|3187451|Superiority or Other||percentage of participants with success|75.0|||||2-Sided|95.0|50.5|99.5|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success|
1731082|NCT00548262|3187451|Superiority or Other||percentage of participants with success|37.5|||||2-Sided|95.0|20.7|54.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success|
1731083|NCT00548262|3187452|Superiority or Other||percentage of participants with success|62.1|||||2-Sided|95.0|44.4|79.7|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success|
1731084|NCT00548262|3187452|Superiority or Other||percentage of participants with success|66.7|||||2-Sided|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success|
1731085|NCT00548262|3187452|Superiority or Other||percentage of participants with success|59.4|||||2-Sided|95.0|42.4|76.4|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success|
1731086|NCT00548262|3187452|Superiority or Other||percentage of participants with success|58.3|||||2-Sided|95.0|30.4|86.2|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success|
1731087|NCT00548262|3187452|Superiority or Other||percentage of participants with success|61.5|||||2-Sided|95.0|46.3|76.8|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success|
1731088|NCT00548262|3187452|Superiority or Other||percentage of participants with success|40.0|||||2-Sided|95.0|0.0|82.9|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success|
1731089|NCT00548262|3187452|Superiority or Other||percentage of participants with success|58.1|||||2-Sided|95.0|43.4|72.9|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success|
1731090|NCT00548262|3187452|Superiority or Other||percentage of participants with success|62.2|||||2-Sided|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success|
1731091|NCT00548262|3187452|Superiority or Other||percentage of participants with success|42.9|||||2-Sided|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success|
1731092|NCT00548262|3187452|Superiority or Other||percentage of participants with success|59.1|||||2-Sided|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success|
1731093|NCT00548262|3187452|Superiority or Other||percentage of participants with success|56.0|||||2-Sided|95.0|36.5|75.5|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success|
1731094|NCT00548262|3187452|Superiority or Other||percentage of participants with success|63.2|||||2-Sided|95.0|41.5|84.8|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success|
1731095|NCT00548262|3187452|Superiority or Other||percentage of participants with success|62.2|||||2-Sided|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success|
1731096|NCT00548262|3187452|Superiority or Other||percentage of participants with success|42.9|||||2-Sided|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success|
1731097|NCT00548262|3187452|Superiority or Other||percentage of participants with success|64.5|||||2-Sided|95.0|47.7|81.4|||||95% CI based on normal approximation to the binomial.|TPN (No): Success|
1731098|NCT00548262|3187452|Superiority or Other||percentage of participants with success|46.2|||||2-Sided|95.0|19.1|73.3|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success|
1731099|NCT00548262|3187452|Superiority or Other||percentage of participants with success|83.3|||||2-Sided|95.0|53.5|100.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success|
1731100|NCT00548262|3187452|Superiority or Other||percentage of participants with success|55.3|||||2-Sided|95.0|39.5|71.1|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success|
1731101|NCT00548262|3187452|Superiority or Other||percentage of participants with success|80.0|||||2-Sided|95.0|44.9|100.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success|
1731102|NCT00548262|3187452|Superiority or Other||percentage of participants with success|56.4|||||2-Sided|95.0|40.8|72.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success|
1731103|NCT00548262|3187452|Superiority or Other||percentage of participants with success|72.7|||||2-Sided|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success|
1731104|NCT00548262|3187452|Superiority or Other||percentage of participants with success|54.5|||||2-Sided|95.0|37.6|71.5|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success|
1731105|NCT00548262|3187452|Superiority or Other||percentage of participants with success|66.7|||||2-Sided|95.0|40.0|93.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success|
1731106|NCT00548262|3187452|Superiority or Other||percentage of participants with success|56.3|||||2-Sided|95.0|39.1|73.4|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success|
1731107|NCT00548262|3187453|Superiority or Other||percentage of participants with success|62.1|||||2-Sided|95.0|44.4|79.7|||||95% CI based on normal approximation to the binomial.|Non-neutropenic: Success|
1731108|NCT00548262|3187453|Superiority or Other||percentage of participants with success|66.7|||||2-Sided|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Neutropenic: Success|
1731109|NCT00548262|3187453|Superiority or Other||percentage of participants with success|62.5|||||2-Sided|95.0|45.7|79.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (No): Success|
1731110|NCT00548262|3187453|Superiority or Other||percentage of participants with success|50.0|||||2-Sided|95.0|21.7|78.3|||||95% CI based on normal approximation to the binomial.|Systemic steroids/immunos (Yes): Success|
1731111|NCT00548262|3187453|Superiority or Other||percentage of participants with success|64.1|||||2-Sided|95.0|49.0|79.2|||||95% CI based on normal approximation to the binomial.|Pancreatitis (No): Success|
1731112|NCT00548262|3187453|Superiority or Other||percentage of participants with success|20.0|||||2-Sided|95.0|0.0|55.1|||||95% CI based on normal approximation to the binomial.|Pancreatitis (Yes): Success|
1731113|NCT00548262|3187453|Superiority or Other||percentage of participants with success|58.1|||||2-Sided|95.0|43.4|72.9|||||95% CI based on normal approximation to the binomial.|Chemotherapy (No): Success|
1731114|NCT00548262|3187453|Superiority or Other||percentage of participants with success|62.2|||||2-Sided|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (No): Success|
1731115|NCT00548262|3187453|Superiority or Other||percentage of participants with success|42.9|||||2-Sided|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Renal insufficiency (Yes): Success|
1731116|NCT00548262|3187453|Superiority or Other||percentage of participants with success|59.1|||||2-Sided|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Solid organ transplant (No): Success|
1731117|NCT00548262|3187453|Superiority or Other||percentage of participants with success|60.0|||||2-Sided|95.0|40.8|79.2|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (No): Success|
1731118|NCT00548262|3187453|Superiority or Other||percentage of participants with success|57.9|||||2-Sided|95.0|35.7|80.1|||||95% CI based on normal approximation to the binomial.|Abdominal surgery (Yes): Success|
1731119|NCT00548262|3187453|Superiority or Other||percentage of participants with success|62.2|||||2-Sided|95.0|46.5|77.8|||||95% CI based on normal approximation to the binomial.|Dialysis (No): Success|
1731120|NCT00548262|3187453|Superiority or Other||percentage of participants with success|42.9|||||2-Sided|95.0|6.2|79.5|||||95% CI based on normal approximation to the binomial.|Dialysis (Yes): Success|
1731121|NCT00548262|3187453|Superiority or Other||percentage of participants with success|67.7|||||2-Sided|95.0|51.3|84.2|||||95% CI based on normal approximation to the binomial.|TPN (No): Success|
1731122|NCT00548262|3187453|Superiority or Other||percentage of participants with success|38.5|||||2-Sided|95.0|12.0|64.9|||||95% CI based on normal approximation to the binomial.|TPN (Yes): Success|
1731123|NCT00548262|3187453|Superiority or Other||percentage of participants with success|83.3|||||2-Sided|95.0|53.5|100.0|||||95% CI based on normal approximation to the binomial.|CV Catheter (No): Success|
1731124|NCT00548262|3187453|Superiority or Other||percentage of participants with success|55.3|||||2-Sided|95.0|39.5|71.1|||||95% CI based on normal approximation to the binomial.|CV Catheter (Yes): Success|
1731125|NCT00548262|3187453|Superiority or Other||percentage of participants with success|80.0|||||2-Sided|95.0|44.9|100.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (No): Success|
1731126|NCT00548262|3187453|Superiority or Other||percentage of participants with success|56.4|||||2-Sided|95.0|40.8|72.0|||||95% CI based on normal approximation to the binomial.|Antibiotics (Yes): Success|
1731127|NCT00548262|3187453|Superiority or Other||percentage of participants with success|72.7|||||2-Sided|95.0|46.4|99.0|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (No): Success|
1731128|NCT00548262|3187453|Superiority or Other||percentage of participants with success|54.5|||||2-Sided|95.0|37.6|71.5|||||95% CI based on normal approximation to the binomial.|Mechanical ventilation (Yes): Success|
1731129|NCT00548262|3187453|Superiority or Other||percentage of participants with success|66.7|||||2-Sided|95.0|40.0|93.3|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (No): Success|
1731130|NCT00548262|3187453|Superiority or Other||percentage of participants with success|56.3|||||2-Sided|95.0|39.1|73.4|||||95% CI based on normal approximation to the binomial.|ICU stay ≥ 4 days (Yes): Success|
1731131|NCT00548262|3187454|Superiority or Other||percentage of participants with success|28.6|||||2-Sided|95.0|0.0|62.0|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success|
1731132|NCT00548262|3187454|Superiority or Other||percentage of participants with success|70.0|||||2-Sided|95.0|41.6|98.4|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success|
1731133|NCT00548262|3187454|Superiority or Other||percentage of participants with success|66.7|||||2-Sided|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success|
1731134|NCT00548262|3187454|Superiority or Other||percentage of participants with success|47.6|||||2-Sided|95.0|26.3|69.0|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success|
1731135|NCT00548262|3187455|Superiority or Other||percentage of participants with success|57.1|||||2-Sided|95.0|20.5|93.8|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success|
1731136|NCT00548262|3187455|Superiority or Other||percentage of participants with success|80.0|||||2-Sided|95.0|55.2|100.0|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success|
1731137|NCT00548262|3187455|Superiority or Other||percentage of participants with success|16.7|||||2-Sided|95.0|0.0|46.5|||||95% CI based on normal approximation to the binomial.|Candida parapsilosis: Success|
1731138|NCT00548262|3187455|Superiority or Other||percentage of participants with success|66.7|||||2-Sided|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success|
1731139|NCT00548262|3187455|Superiority or Other||percentage of participants with success|66.7|||||2-Sided|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida glabrata: Success|
1731140|NCT00548262|3187455|Superiority or Other||percentage of participants with success|52.4|||||2-Sided|95.0|31.0|73.7|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success|
1731141|NCT00548262|3187456|Superiority or Other||percentage of participants with success|57.1|||||2-Sided|95.0|20.5|93.8|||||95% CI based on normal approximation to the binomial.|Unidentifiable: Success|
1731142|NCT00548262|3187456|Superiority or Other||percentage of participants with success|80.0|||||2-Sided|95.0|55.2|100.0|||||95% CI based on normal approximation to the binomial.|Candida tropicalis: Success|
1731143|NCT00548262|3187456|Superiority or Other||percentage of participants with success|16.7|||||2-Sided|95.0|0.0|46.5|||||95% CI based on normal approximation to the binomial.|Candida parapsilosis: Success|
1731144|NCT00548262|3187456|Superiority or Other||percentage of participants with success|66.7|||||2-Sided|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida krusei: Success|
1731145|NCT00548262|3187456|Superiority or Other||percentage of participants with success|66.7|||||2-Sided|95.0|13.3|100.0|||||95% CI based on normal approximation to the binomial.|Candida glabrata: Success|
1731146|NCT00548262|3187456|Superiority or Other||percentage of participants with success|50.0|||||2-Sided|95.0|0.0|100.0|||||95% CI based on normal approximation to the binomial.|Candida famata: Success|
1731147|NCT00548262|3187456|Superiority or Other||percentage of participants with success|52.4|||||2-Sided|95.0|31.0|73.7|||||95% CI based on normal approximation to the binomial.|Candida albicans: Success|
1731148|NCT00548262|3187457|Superiority or Other||percentage of participants with success|47.7|||||2-Sided|95.0|33.0|62.5|||||95% CI based on normal approximation to the binomial.|Week 2 Follow-up Success|
1731149|NCT00548262|3187457|Superiority or Other||percentage of participants with success|59.1|||||2-Sided|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|EIVT Success|
1731150|NCT00548262|3187458|Superiority or Other||percentage of participants with success|59.1|||||2-Sided|95.0|44.6|73.6|||||95% CI based on normal approximation to the binomial.|Success at EOT|
1731151|NCT00548249|3187464|Superiority or Other|||||||0.625||||||Threshold for statistical significance p < 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect|
1731152|NCT00548249|3187464|Superiority or Other|||||||0.375||||||Threshold for statistical significance p < 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect|
1731153|NCT00548249|3187464|Superiority or Other|||||||0.049||||||Threshold for statistical significance p < 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect|
1731154|NCT00548249|3187464|Superiority or Other|||||||0.234||||||Threshold for statistical significance p < 0.05|ANOVA|||Each dose was compared to placebo using an ANOVA model with treatment as the effect.|
1731155|NCT00548249|3187465|Superiority or Other||Cox Proportional Hazard|1.77||||0.299|2-Sided|95.0|0.6|5.19|||Log Rank||||
1731156|NCT00548249|3187465|Superiority or Other||Cox Proportional Hazard|0.8||||0.748|2-Sided|95.0|0.21|3.02|||Log Rank||||
1731157|NCT00548249|3187465|Superiority or Other||Cox Proportional Hazard|1.17||||0.807|2-Sided|95.0|0.33|4.09|||Log Rank||||
1731158|NCT00548249|3187465|Superiority or Other||Cox Proportional Hazard|1.0||||0.999|2-Sided|95.0|0.3|3.32||p-value not adjusted for multiple comparisons|Log Rank|||Hazard ratio with 95% confidence intervals comparing each SFP treatment group to placebo, and p-value from cox proportional hazards model|
1731159|NCT00548132|3187493|Superiority or Other||Risk Ratio (RR)|0.46|Standard Deviation|0.05||0.05|2-Sided|95.0|0.24|0.9|||Cochran-Mantel-Haenszel|This was calculated based on the assumption that only 85% of eligible patients will consent to the study.|The standard of care is the numerator and the intervention group is the denominator|The null hypothesis is that the Bloostream infection per 1000 catheter days will be similar in both groups. In 2004, 6122 catheter days occurred in by both ICUs. If 15% of these were excluded, then 5203 catheter days/year will be eligible for analysis. The difference in infection rates will reach statistical significance at 12 months with a P-value of 0.04. At 24 months, the P-value will be more significant at 0.006.|
1731160|NCT00547638|3187520|Superiority or Other|||||||1|||||||Fisher Exact||||
1731161|NCT00547638|3187521|Superiority or Other|||||||0.883||||||Intent to treat population was analyzed.|Fisher Exact||||
1731162|NCT00547638|3187521|Superiority or Other|||||||0.188||||||Intent to treat population was analyzed.|Fisher Exact||||
1731163|NCT00547638|3187522|Superiority or Other|||||||1||||||Differences between treatment groups in the incidence rate of infection at Day 30 were compared using the Fisher's Exact Test.|Fisher Exact||||
1731164|NCT00547638|3187522|Superiority or Other|||||||1||||||Differences between treatment groups in the incidence rate of infection at Day 14 and Day 30 were compared using the Fisher's Exact Test.|Fisher Exact||||
1731487|NCT00543569|3188241|Superiority or Other||Difference|3.6|||||2-Sided|90.0|-4.6|11.7||||||Graft survival at 12 months|
1731165|NCT00547638|3187523|Superiority or Other|||||||0.457||||||The total mHCS scores are summarized as proportion of subjects with good outcome (total scores of zero) and a comparison of treatment groups by Fisher Exact Test was performed to confirm differences in groups.|Fisher Exact||||
1731166|NCT00547638|3187524|Non-Inferiority or Equivalence|Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of DERMABOND HVD successful subjects) does not exceed 8%.|Difference in Proportion of Successes|-7.9|||||2-Sided|95.0|-17.7|1.0|||||The value for the Estimated Parameter is expressed as a percentage and is defined as the difference in the proportion of sucesses between study groups.||
1731167|NCT00547378|3187572|Superiority|||||||0.016|||||||Cochran-Mantel-Haenszel|The two-sided Cochran-Mantel-Haenszel (CMH) test, stratified for center, was used to test the difference in responder rates between the 2 groups|||
1731168|NCT00547248|3187605|Non-Inferiority|Non-inferiority was demonstrated if the difference in terms of incidence of post-immunization febrile reactions (rectal temperature > 39.0°C) in Synflorix™ vaccine minus Prevenar™ did not exceed the pre-defined clinically acceptable threshold of 5% + half the incidence in Prevenar.|Difference in percentage|0.89|||||2-Sided|95.0|-4.82|5.59|||||||
1731169|NCT00547157|3187606|Superiority or Other||Difference in complete response rate|0.029|||||2-Sided|95.0|-0.103|0.141|||||Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.||
1731170|NCT00547157|3187606|Superiority or Other||Odds Ratio (OR)|1.278||||0.807|2-Sided|95.0|0.438|4.043|||Regression, Logistic||The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.||
1731171|NCT00547157|3187607|Superiority or Other||Difference in objective response rate|-0.044|||||2-Sided|95.0|-0.187|0.112|||||Difference is objective response rate in the panitumumab plus radiotherapy arm minus the rate in the chemoradiotherapy arm.||
1731172|NCT00547157|3187607|Superiority or Other||Odds Ratio (OR)|0.791||||0.5744|2-Sided|95.0|0.342|1.785|||Regression, Logistic||The odd ratio is defined as the odds of having an objective response in the panitumumab plus radiotherapy arm relative to the odds in the chemoradiotherapy arm.||
1731173|NCT00547157|3187608|Superiority or Other||Hazard Ratio (HR)|1.593||||0.1039|2-Sided|95.0|0.909|2.793|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy||
1731174|NCT00547157|3187609|Superiority or Other||Hazard Ratio (HR)|1.731||||0.0259|2-Sided|95.0|1.068|2.806|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.||
1731175|NCT00547157|3187610|Superiority or Other||Hazard Ratio (HR)|1.613||||0.0601|2-Sided|95.0|0.98|2.656|||Regression, Cox||Hazard ratio is presented as panitumumab plus radiotherapy:chemoradiotherapy.||
1731176|NCT00547157|3187611|Superiority or Other||Risk Difference (RD)|-0.09|||||2-Sided|95.0|-0.26|0.07|||||difference is PRT - CRT||
1731177|NCT00546910|3187633|Superiority or Other||Mean Difference (Final Values)|0.12||||0.178|2-Sided|95.0|0.05|0.28||P-value is for Multi Response overall for morning, noon and evening. Multi Response was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731178|NCT00546910|3187633|Superiority or Other||Mean Difference (Final Values)|0.94|||<|0.001|2-Sided|95.0|0.69|1.18||P-value is for Error Rate overall for morning, noon and evening. Error Rate was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731179|NCT00546910|3187634|Superiority or Other||Mean Difference (Final Values)|0.17||||0.022|2-Sided|95.0|0.02|0.31||P-value is for Anticipatory Response overall for morning, noon and evening. Anticipatory Response was not tested in the primary analysis but is a secondary endpoint.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731180|NCT00546910|3187634|Superiority or Other||Mean Difference (Final Values)|0.5|||<|0.001|2-Sided|95.0|0.31|0.68||P-value is for Commission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Commission Error was tested at rank 4.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731181|NCT00546910|3187635|Superiority or Other||Mean Difference (Final Values)|0.5|||<|0.001|2-Sided|95.0|0.26|0.73||P-value is for Normalized Variation of Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Normalized Variation of Reaction Time was tested at rank 10.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731182|NCT00546910|3187635|Superiority or Other||Mean Difference (Final Values)|0.41|||<|0.001|2-Sided|95.0|0.17|0.65||P-value is for Mean Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Mean reaction time was tested at rank 2.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731183|NCT00546910|3187635|Superiority or Other||Mean Difference (Final Values)|0.7|||<|0.001|2-Sided|95.0|0.46|0.93||P-value is for Omission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Omission error was tested at rank 7.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731184|NCT00546910|3187635|Superiority or Other||Mean Difference (Final Values)|1.01|||<|0.001|2-Sided|95.0|0.66|1.35||P-value is for Reaction Time Variation overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Reaction time variation was tested at rank 1.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731185|NCT00546910|3187636|Superiority or Other||Mean Difference (Final Values)|0.62|||<|0.001|2-Sided|95.0|0.31|0.93||P-value for Item 11 (difficulty falling asleep).|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731186|NCT00546910|3187636|Superiority or Other||Mean Difference (Final Values)|1.18|||<|0.002|2-Sided|95.0|0.42|1.93||P-value for Morning subscore|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731187|NCT00546910|3187636|Superiority or Other||Mean Difference (Final Values)|3.96|||<|0.001|2-Sided|95.0|2.49|5.44||P-value for Evening subscore|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731188|NCT00546910|3187636|Superiority or Other||Mean Difference (Final Values)|5.74|||<|0.001|2-Sided|95.0|3.55|7.92||P-value for Total Score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731189|NCT00546910|3187637|Superiority or Other||Mean Difference (Final Values)|1.11|||<|0.001|2-Sided|95.0|0.76|1.46||P-value for CGI-S ADHD score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)|
1731190|NCT00546910|3187638|Superiority or Other||Mean Difference (Final Values)|11.6|||<|0.001|2-Sided|95.0|8.2|14.99||P-value for ADHD-RS Total Score|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.||Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)|
1731191|NCT00546910|3187639|Superiority or Other||Mean Difference (Final Values)|0.38|||<|0.001|2-Sided|95.0|0.18|0.58||P-value is for Motion Simplicity overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Motion Simplicity was tested at rank 9.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731192|NCT00546910|3187639|Superiority or Other||Mean Difference (Final Values)|1.0|||<|0.001|2-Sided|95.0|0.78|1.22||P-value is for Microevents overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Microevents was tested at rank 3.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731193|NCT00546910|3187639|Superiority or Other||Mean Difference (Final Values)|1.08|||<|0.001|2-Sided|95.0|0.81|1.35||P-value is for Area overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Area was tested at rank 6.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731194|NCT00546910|3187639|Superiority or Other||Mean Difference (Final Values)|1.27|||<|0.001|2-Sided|95.0|0.98|1.57||P-value is for Distance overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Distance was tested at rank 5.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731195|NCT00546910|3187639|Superiority or Other||Mean Difference (Final Values)|0.69|||<|0.001|2-Sided|95.0|0.52|0.87||P-value is for Time Active overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Time Active was tested at rank 8.|Mixed Models Analysis|Positive values for the mean difference are in favor of the atomoxetine arm.|||
1731196|NCT00546884|3187656|Superiority or Other||Odds Ratio (OR)|4.16|||<|0.05|2-Sided||||||Chi-squared||||
1731197|NCT00546871|3187677|Superiority or Other||Poisson|0.067|||||1-Sided|99.0||0.134|||||||
1731198|NCT00546754|3187703|Superiority or Other|||||||0.725|||||||ANOVA||||
1731199|NCT00546754|3187704|Superiority or Other|||||||0.386|||||||ANOVA||||
1731200|NCT00546754|3187705|Superiority or Other|||||||0.218|||||||ANOVA||||
1731201|NCT00546754|3187706|Superiority or Other|||||||0.899|||||||ANOVA||||
1731202|NCT00546754|3187707|Superiority or Other||||||<|0.001|||||||ANOVA||||
1731203|NCT00546754|3187708|Superiority or Other|||||||0.935|||||||ANOVA||||
1731204|NCT00546754|3187709|Superiority or Other||||||<|0.001|||||||ANOVA||||
1731205|NCT00546754|3187710|Superiority or Other|||||||0.02|||||||Log Rank||||
1731206|NCT00546754|3187711|Superiority or Other|||||||0.662|||||||Fisher Exact||||
1731207|NCT00546754|3187712|Superiority or Other|||||||0.395|||||||ANOVA||||
1731208|NCT00546754|3187713|Superiority or Other|||||||0.118|||||||Fisher Exact||||
1731209|NCT00546754|3187714|Superiority or Other|||||||0.343|||||||ANOVA||||
1731210|NCT00546754|3187715|Superiority or Other|||||||0.153|||||||ANOVA||||
1731211|NCT00546637|3187732|Superiority or Other||Median Difference (Net)|-0.4||||0.2251||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.||
1731212|NCT00546637|3187733|Superiority or Other||Median Difference (Net)|9.0||||0.0003||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 12|
1731213|NCT00546637|3187733|Superiority or Other||Median Difference (Net)|7.0|||<|0.0001||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 8|
1731214|NCT00546637|3187733|Superiority or Other||Median Difference (Net)|6.0|||<|0.0005||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 4|
1731215|NCT00546637|3187734|Superiority or Other||Mean Difference (Net)|0.3|Standard Error of the Mean|0.9||0.7685||95.0|-1.6|2.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12|
1731216|NCT00546637|3187734|Superiority or Other||Mean Difference (Net)|1.4|Standard Error of the Mean|0.9||0.1085||95.0|-0.3|3.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 4|
1731217|NCT00546637|3187735|Superiority or Other||Mean Difference (Net)|2.2|Standard Error of the Mean|1.2||0.0662||95.0|-0.2|4.6||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12|
1731218|NCT00546637|3187735|Superiority or Other||Mean Difference (Net)|1.9|Standard Error of the Mean|1.1||0.0845||95.0|-0.3|4.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4|
1731219|NCT00546637|3187736|Superiority or Other||Mean Difference (Net)|1.9|Standard Error of the Mean|1.2||0.1136||95.0|-0.4|4.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 12|
1731220|NCT00546637|3187736|Superiority or Other||Mean Difference (Net)|2.1|Standard Error of the Mean|1.1||0.0507||95.0|0.0|4.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4|
1731221|NCT00546637|3187737|Superiority or Other||Mean Difference (Net)|1.3|Standard Error of the Mean|1.1||0.2273||95.0|-0.8|3.4||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 12|
1731222|NCT00546637|3187737|Superiority or Other||Mean Difference (Net)|1.7|Standard Error of the Mean|1.0||0.0941||95.0|-0.3|3.8||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net) = Least squares mean|Week 4|
1731223|NCT00546637|3187738|Superiority or Other||Mean Difference (Net)|1.5|Standard Error of the Mean|1.0||0.1373||95.0|-0.5|3.4||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 12|
1731224|NCT00546637|3187738|Superiority or Other||Mean Difference (Net)|1.9|Standard Error of the Mean|0.9||0.0412||95.0|0.1|3.6||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean Difference (net)= Least squares mean|Week 4|
1731225|NCT00546637|3187739|Superiority or Other||Mean Difference (Net)|-2.8|Standard Error of the Mean|1.0||0.0068||95.0|-4.8|-0.8||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12|
1731226|NCT00546637|3187739|Superiority or Other||Mean Difference (Net)|-2.7|Standard Error of the Mean|0.9||0.004||95.0|-4.5|-0.9||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4|
1731227|NCT00546637|3187740|Superiority or Other|||||||0.9402||||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel||||
1731228|NCT00546637|3187741|Superiority or Other|||||||0.7433||||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel||||
1731229|NCT00546637|3187742|Superiority or Other|||||||0.5775||||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel||||
1731230|NCT00546637|3187743|Superiority or Other|||||||0.1136||||||P-value was obtained from a Cochran-Mantel-Haenszel test with modified ridit scoring, stratified by center. No adjustment of p-value was made for multiple comparisons.|Cochran-Mantel-Haenszel||||
1731231|NCT00546637|3187744|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|0.1||0.3302|2-Sided|95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q7|
1731232|NCT00546637|3187744|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.1||0.8058||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q6|
1731233|NCT00546637|3187744|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.1||0.9706||95.0|-0.2|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q5|
1731234|NCT00546637|3187744|Superiority or Other||Mean Difference (Net)|-0.2|Standard Error of the Mean|0.1||0.0631||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q4|
1731235|NCT00546637|3187744|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|0.1||0.2032||95.0|-0.1|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q3|
1731236|NCT00546637|3187744|Superiority or Other||Mean Difference (Net)|-0.2|Standard Error of the Mean|0.1||0.0614||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q2|
1731237|NCT00546637|3187744|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|0.1||0.1595||95.0|0.0|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12 Q1|
1731238|NCT00546637|3187745|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|0.1||0.4066|2-Sided|95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q7|
1731239|NCT00546637|3187745|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|0.1||0.3079||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q6|
1731401|NCT00544882|3188110|Superiority or Other|||||||0.2809|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.|
1731240|NCT00546637|3187745|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.1||0.4102||95.0|-0.2|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q5|
1731241|NCT00546637|3187745|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.1||0.1604||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q4|
1731242|NCT00546637|3187745|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|0.1||0.3242||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q3|
1731243|NCT00546637|3187745|Superiority or Other||Mean Difference (Net)|-0.3|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.5|-0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q2|
1731244|NCT00546637|3187745|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.1|<|0.6621||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4 Q1|
1731245|NCT00546637|3187746|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.1||0.5839||95.0|-0.2|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12|
1731246|NCT00546637|3187746|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.1||0.1472||95.0|-0.2|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4|
1731247|NCT00546637|3187747|Superiority or Other||Mean Difference (Net)|0.2|Standard Error of the Mean|0.2||0.401||95.0|-0.3|0.7||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12|
1731248|NCT00546637|3187747|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|0.2||0.7564||95.0|-0.4|0.5||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4|
1731249|NCT00546637|3187748|Superiority or Other||Mean Difference (Net)|-0.3|Standard Error of the Mean|0.2||0.1744||95.0|-0.6|0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12|
1731250|NCT00546637|3187748|Superiority or Other||Mean Difference (Net)|-0.4|Standard Error of the Mean|0.2||0.0223||95.0|-0.7|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4|
1731251|NCT00546637|3187749|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.4||0.9274||95.0|-0.8|0.7||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12|
1731252|NCT00546637|3187749|Superiority or Other||Mean Difference (Net)|-0.3|Standard Error of the Mean|0.4||0.3579||95.0|-1.0|0.4||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4|
1731253|NCT00546637|3187750|Superiority or Other||Mean Difference (Net)|-1.0|Standard Error of the Mean|0.7||0.1231||95.0|-2.3|0.3||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12|
1731254|NCT00546637|3187750|Superiority or Other||Mean Difference (Net)|-1.7|Standard Error of the Mean|0.6||0.0051||95.0|-2.9|-0.5||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4|
1731255|NCT00546637|3187752|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.1||0.6572||95.0|-0.1|0.2||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12|
1731256|NCT00546637|3187752|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.1||0.1748||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4|
1731257|NCT00546637|3187753|Superiority or Other|||||||0.0025||||||P-value for median was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 4|
1731258|NCT00546637|3187754|Superiority or Other||Median Difference (Net)|0.0||||0.0825||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 12|
1731259|NCT00546637|3187754|Superiority or Other||Median Difference (Net)|-0.33||||0.0062||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was based on Hodges-Lehmann estimate of the location shift between the two groups.|Week 4|
1731402|NCT00544882|3188110|Superiority or Other|||||||0.1523|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 25 time point.|
1731260|NCT00546637|3187756|Superiority or Other||Median Difference (Net)|0.0||||0.4449||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was estimated using Hodges-Lehmann estimate of the location shift between the two groups.|Week 12|
1731261|NCT00546637|3187756|Superiority or Other||Mean Difference (Net)|0.0||||0.3847||95.0||||P-value was based on Van Elteren's Test adjusted by baseline quartiles. No adjustment of p-value was made for multiple comparisons.|Van Elteren's Test||Median difference was estimated using Hodges-Lehmann estimate of the location shift between the two groups.|Week 4|
1731262|NCT00546637|3187758|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.1||0.0855||95.0|-0.3|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12|
1731263|NCT00546637|3187758|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.1||0.1112||95.0|-0.2|0.0||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4|
1731264|NCT00546637|3187759|Superiority or Other|||||||0.0027||||||P-value was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 12|
1731265|NCT00546637|3187759|Superiority or Other|||||||0.0012||||||P-value was based on a ranked ANCOVA model with terms for country, treatment, and ranked baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|Ranked ANCOVA|Treatment comparisons were performed only if the corresponding numerical change from Baseline at the same visit was statistically significant.||Week 4|
1731266|NCT00546637|3187760|Superiority or Other||Mean Difference (Net)|-0.4|Standard Error of the Mean|0.2||0.009||95.0|-0.7|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 12|
1731267|NCT00546637|3187760|Superiority or Other||Mean Difference (Net)|-0.4|Standard Error of the Mean|0.2||0.0056||95.0|-0.8|-0.1||P-value was based on ANCOVA model with terms for country, treatment, and baseline value as a covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean|Week 4|
1731268|NCT00546637|3187762|Superiority or Other||Mean Difference (Net)|-0.5|Standard Error of the Mean|0.2||0.0621||95.0|-1.0|0.0||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (net) = Least squares mean||
1731269|NCT00546637|3187763|Superiority or Other||Mean Difference (Net)|-0.4|Standard Error of the Mean|0.3||0.1959||95.0|-0.9|0.2||P-value was based on an ANCOVA model with terms for country, treatment, and baseline value as covariate. No adjustment of p-value was made for multiple comparisons.|ANCOVA||Mean difference (Net) = Least squares mean|The null hypothesis was that the mean change from Baseline in 24-hour micturition-related urgency was the same at Week 12 for the two treatment groups: fesoterodine + alpha-blocker vs. placebo + alpha-blocker. It was estimated that 900 randomized subjects would have 85% power to detect a mean difference of -0.93(SD = 4.15) between the 2 treatments on the primary endpoint,mean reduction of micturition-related urgency episodes/24hr from Baseline to Week 12,assuming a 10% non-evaluability rate.|
1731270|NCT00546572|3187768|Superiority or Other||difference in proportions|-6.9||||0.039|2-Sided|95.0|-13.6|-0.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Aggravated generalized muscle pain: difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731271|NCT00546572|3187768|Superiority or Other||difference in proportions|-7.9||||0.034|2-Sided|95.0|-15.2|-0.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|New generalized muscle pain: difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731272|NCT00546572|3187773|Superiority or Other||difference in proportions|-2.3||||0.042|2-Sided|95.0|-4.9|-0.1|||Limitation of arm movement: any; differe||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Limitation of arm movement: severe; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731273|NCT00546572|3187773|Superiority or Other||difference in proportions|-2.3||||0.02|2-Sided|95.0|-4.8|-0.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Limitation of arm movement: moderate; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731274|NCT00546572|3187773|Superiority or Other||difference in proportions|-14.9|||<|0.001|2-Sided|95.0|-20.8|-9.0|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Limitation of arm movement: mild; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731275|NCT00546572|3187773|Superiority or Other||difference in proportions|-17.1|||<|0.001|2-Sided|95.0|-23.1|-11.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Limitation of arm movement: any; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731276|NCT00546572|3187773|Superiority or Other||difference in proportions|-0.9|||<|0.539|2-Sided|95.0|-3.5|1.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Pain: severe; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731357|NCT00545688|3187941|Superiority or Other||Hazard Ratio (HR)|2.05||||0.0268|2-Sided|95.0|1.07|3.93|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS|
1736195|NCT00486902|3196411|Superiority or Other|||||||0.87|||||||Fisher Exact||||
1731277|NCT00546572|3187773|Superiority or Other||difference in proportions|-16.1|||<|0.001|2-Sided|95.0|-21.7|-10.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Pain: moderate; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731278|NCT00546572|3187773|Superiority or Other||difference in proportions|-4.0|||<|0.284|2-Sided|95.0|-11.3|3.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Pain: mild; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731279|NCT00546572|3187773|Superiority or Other||Chan & Zhang|-6.8|||<|0.062|2-Sided|95.0|-14.0|0.4|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Pain: any; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731280|NCT00546572|3187773|Superiority or Other||difference in proportions|-4.8|||<|0.001|2-Sided|95.0|-7.9|-2.7|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Swelling: severe; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731281|NCT00546572|3187773|Superiority or Other||difference in proportions|-9.6|||<|0.001|2-Sided|95.0|-14.2|-5.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Swelling: moderate; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731282|NCT00546572|3187773|Superiority or Other||difference in proportions|-5.1|||<|0.048|2-Sided|95.0|-10.2|-0.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Swelling: mild; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731283|NCT00546572|3187773|Superiority or Other||difference in proportions|-12.7|||<|0.001|2-Sided|95.0|-18.5|-7.0|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Swelling: any; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731284|NCT00546572|3187773|Superiority or Other||difference in proportions|-3.2|||<|0.028|2-Sided|95.0|-6.3|-0.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Redness: severe; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731285|NCT00546572|3187773|Superiority or Other||difference in proportions|-6.8|||<|0.002|2-Sided|95.0|-11.3|-2.3|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Redness: moderate; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731286|NCT00546572|3187773|Superiority or Other||difference in proportions|-4.0|||<|0.129|2-Sided|95.0|-9.1|1.1|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Redness: mild; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731287|NCT00546572|3187773|Superiority or Other||difference in proportions|-11.4|||<|0.001|2-Sided|95.0|-17.3|-5.6|||Chan & Zhang||Exact 2-sided confidence interval and corresponding p-value (based on Chan & Zhang) for the difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|Redness: any; difference in proportions, [13vPnC] – [23vPS], expressed as a percentage.|
1731288|NCT00546572|3187774|Superiority or Other||ratio of geometric mean titer|12.1|||||2-Sided|95.0|8.92|16.44|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )– (23vPS)].|"Serotype 6A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was >2."|
1731289|NCT00546572|3187775|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).|ratio of geometric mean titer|7.3|||||2-Sided|95.0|5.36|9.82|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )– (23vPS)].|Serotype 23F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731290|NCT00546572|3187775|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).|ratio of geometric mean titer|1.5|||||2-Sided|95.0|1.09|1.93|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )– (23vPS)].|Serotype 19F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731291|NCT00546572|3187775|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).|ratio of geometric mean titer|1.7|||||2-Sided|95.0|1.37|2.1|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )– (23vPS)].|Serotype 19A: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731292|NCT00546572|3187775|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).|ratio of geometric mean titer|2.0|||||2-Sided|95.0|1.53|2.69|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )– (23vPS)].|Serotype 18C: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731293|NCT00546572|3187775|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).|ratio of geometric mean titer|0.8|||||2-Sided|95.0|0.62|1.13|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )– (23vPS)].|Serotype 14: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731294|NCT00546572|3187775|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).|ratio of geometric mean titer|1.8|||||2-Sided|95.0|1.18|2.62|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )– (23vPS)].|Serotype 9V: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731295|NCT00546572|3187775|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).|ratio of geometric mean titer|1.2|||||2-Sided|95.0|0.8|1.67|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )– (23vPS)].|Serotype 7F: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731296|NCT00546572|3187775|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).|ratio of geometric mean titer|3.8|||||2-Sided|95.0|2.78|5.07|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )– (23vPS)].|Serotype 6B: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731297|NCT00546572|3187775|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).|ratio of geometric mean titer|1.6|||||2-Sided|95.0|1.21|2.06|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )– (23vPS)].|Serotype 5: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731298|NCT00546572|3187775|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).|ratio of geometric mean titer|2.3|||||2-Sided|95.0|1.66|3.25|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )– (23vPS)].|Serotype 4: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731299|NCT00546572|3187775|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).|ratio of geometric mean titer|1.1|||||2-Sided|95.0|0.91|1.34|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )– (23vPS)].|Serotype 3: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731300|NCT00546572|3187775|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).|ratio of geometric mean titer|1.4|||||2-Sided|95.0|1.1|1.76|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(13vPnC / 13vPnC )– (23vPS)].|Serotype 1: ratio of GMT (13vPnC / 13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731301|NCT00546572|3187776|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).|geometric mean fold rise|1.9|||||2-Sided|95.0|1.6|2.14|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 23F: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.|
1731302|NCT00546572|3187776|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||2-Sided|95.0|0.83|1.15|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 19F: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.|
1731303|NCT00546572|3187776|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||2-Sided|95.0|0.89|1.07|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 19A: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.|
1731304|NCT00546572|3187776|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).|geometric mean fold rise|1.1|||||2-Sided|95.0|0.97|1.23|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 18C: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.|
1731403|NCT00544882|3188110|Superiority or Other|||||||0.0955|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.|
1731305|NCT00546572|3187776|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).|geometric mean fold rise|0.9|||||2-Sided|95.0|0.79|1.05|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 14: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.|
1731306|NCT00546572|3187776|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).|geometric mean fold rise|0.9|||||2-Sided|95.0|0.69|1.15|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 9V: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.|
1731307|NCT00546572|3187776|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||2-Sided|95.0|0.65|1.01|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 7F: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.|
1731308|NCT00546572|3187776|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).|geometric mean fold rise|1.2|||||2-Sided|95.0|1.02|1.35|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 6B: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.|
1731309|NCT00546572|3187776|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).|geometric mean fold rise|1.2|||||2-Sided|95.0|1.03|1.4|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 6A: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.|
1731310|NCT00546572|3187776|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||2-Sided|95.0|0.73|0.94|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 5: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.|
1731311|NCT00546572|3187776|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).|geometric mean fold rise|0.8|||||2-Sided|95.0|0.68|0.92|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 4: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.|
1731312|NCT00546572|3187776|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||2-Sided|95.0|0.91|1.11|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 3: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.|
1731313|NCT00546572|3187776|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95% confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion).|geometric mean fold rise|1.0|||||2-Sided|95.0|0.85|1.1|||||Confidence intervals are back transformations of a CI based on the student t distribution for the mean logarithm of the titers.|Serotype 1: geometric mean fold rise (GMFR) [(13vPnC / 13vPnC) / (13vPnC)] calculated using all participants with available data from both the postvaccination 1 and postvaccination 2 blood draws.|
1731314|NCT00546572|3187777|Superiority or Other||ratio of geometric mean titer|9.6|||||2-Sided|95.0|7.0|13.26|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|"Serotype 6A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.~Statistical significance was demonstrated if the lower limit of the 2-sided 95% confidence interval for the geometric mean ratio was >2."|
1731315|NCT00546572|3187778|Superiority or Other||difference in proportions|43.8|||||2-Sided|95.0|37.4|49.9|||||Exact 2-sided CI (based on Chan and Zhang) for the difference in proportions, 13vPnC – 23vPS expressed as a percentage.|"Serotype 6A: difference in proportions, 13vPnC - 23vPS, expressed as a percentage.~Statistical significance was shown if the lower limit of the 95% CI for the difference in proportions (13vPnC – 23vPS) was > 0."|
1731316|NCT00546572|3187779|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.|ratio of geometric mean titer|3.7|||||2-Sided|95.0|2.69|5.09|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|Serotype 23F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731358|NCT00545688|3187941|Superiority or Other||Hazard Ratio (HR)|1.25||||0.4722|2-Sided|95.0|0.68|2.3|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS|
1731359|NCT00545688|3187941|Superiority or Other||Hazard Ratio (HR)|0.69||||0.2983|2-Sided|95.0|0.34|1.4|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|PFS|
1731317|NCT00546572|3187779|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.|ratio of geometric mean titer|1.6|||||2-Sided|95.0|1.17|2.06|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|Serotype 19F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731318|NCT00546572|3187779|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.|ratio of geometric mean titer|1.8|||||2-Sided|95.0|1.43|2.2|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|Serotype 19A: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731319|NCT00546572|3187779|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.|ratio of geometric mean titer|1.9|||||2-Sided|95.0|1.42|2.5|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|Serotype 18C: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731320|NCT00546572|3187779|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.|ratio of geometric mean titer|1.0|||||2-Sided|95.0|0.73|1.33|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|Serotype 14: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731321|NCT00546572|3187779|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion).|ratio of geometric mean titer|2.0|||||2-Sided|95.0|1.36|2.97|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|Serotype 9V: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale. Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.|
1731322|NCT00546572|3187779|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.|ratio of geometric mean titer|1.5|||||2-Sided|95.0|1.07|2.18|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|Serotype 7F: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731323|NCT00546572|3187779|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.|ratio of geometric mean titer|3.0|||||2-Sided|95.0|2.21|4.13|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|Serotype 6B: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731324|NCT00546572|3187779|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.|ratio of geometric mean titer|2.0|||||2-Sided|95.0|1.55|2.63|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|Serotype 5: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731325|NCT00546572|3187779|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.|ratio of geometric mean titer|2.7|||||2-Sided|95.0|1.93|3.74|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|Serotype 4: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731326|NCT00546572|3187779|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.|ratio of geometric mean titer|1.1|||||2-Sided|95.0|0.91|1.35|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|Serotype 3: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731360|NCT00545688|3187956|Superiority or Other|||||||0.003||||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel||||
1731327|NCT00546572|3187779|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 0.5 (2-fold criterion). Statistical significance demonstrated if the lower limit of the 2-sided 95 % confidence interval for the geometric mean ratio (GMR) was > 1.|ratio of geometric mean titer|1.5|||||2-Sided|95.0|1.17|1.88|||||Confidence intervals for the ratio are back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|Serotype 1: ratio of GMT (13vPnC to 23vPS) calculated by back transforming the mean difference between vaccine groups on the logarithmic scale.|
1731328|NCT00546104|3187849|Superiority or Other||Median Difference (Net)|-0.13|Standard Error of the Mean|0.1||0.3|2-Sided|95.0|-0.3|0.1|||t-test, 1 sided||||
1731329|NCT00546104|3187850|Superiority or Other||Median Difference (Net)|-0.13|Standard Error of the Mean|9.0||0.3|2-Sided|95.0|-30.0|9.0||The p-value is from a paired t-test to test the null hypothesis the mean relative change in Src from baseline to 4 weeks is equal to zero.|t-test, 2 sided|||The median change in SRC from baseline to 4 weeks was estimated.|
1731330|NCT00546052|3187870|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Deviation|8.7||0.613|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.|
1731331|NCT00546052|3187871|Superiority or Other||Mean Difference (Final Values)|-19.2|Standard Deviation|63.8||0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.|
1731332|NCT00546052|3187872|Superiority or Other||Mean Difference (Final Values)|-3.0|Standard Deviation|17.0||0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.|
1731333|NCT00546052|3187873|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Deviation|43.5||0.336|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.|
1731334|NCT00546052|3187874|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Deviation|18.0||0.654|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.|
1731335|NCT00546052|3187875|Superiority or Other||Mean Difference (Net)|-1.5|Standard Deviation|32.1||0.084|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.|
1731336|NCT00546052|3187876|Superiority or Other||Mean Difference (Final Values)|-7.3|Standard Deviation|5.2|<|0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.|
1731337|NCT00546052|3187877|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Deviation|5.4|<|0.001|||||||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null Hypothesis value is 0.|
1731338|NCT00546052|3187878|Superiority or Other||Mean Difference (Final Values)|-9.84|Standard Deviation|8.39|<|0.001||95.0|-10.29|-9.39|||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg.|
1731339|NCT00546052|3187879|Superiority or Other||Mean Difference (Final Values)|-16.95|Standard Deviation|13.34|<|0.001||95.0|-17.62|-16.27|||t-test, 2 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is 0 mm Hg|
1731340|NCT00546052|3187881|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Deviation|0.62||0.999||95.0|0.01|0.07|||t-test, 1 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5mmol/L.|
1731341|NCT00546052|3187882|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Deviation|0.74||0.999||95.0|-0.02|0.06|||t-test, 1 sided|||Single Cohort Study. Statistical Analysis is based on change from baseline. Null hypothesis value is + 0.5%.|
1731342|NCT00545844|3187893|Superiority or Other||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)|
1731343|NCT00545844|3187894|Superiority or Other||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)|
1731344|NCT00545844|3187895|Superiority or Other||||||<|0.001|||||||McNemar-Bowker|||McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)|
1731345|NCT00545844|3187896|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1731346|NCT00545844|3187897|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1731347|NCT00545792|3187904|Superiority or Other||Single point estiamte of 1-yr PFS|0.8|||||2-Sided|95.0|0.56|0.94|||||The reported 1-year PFS rate 80% (Exact 95% CI: 56% - 94%) was the proportion of the patients remained progression free after 12 months.|Single-arm feasibility study; Kaplan Meier analysis was applied to estimate one-year PFS distribution as well as to calculate proportion of patients remain progression free by month 12.|
1731348|NCT00545740|3187924|Superiority or Other|||||||0.78|||||||Cochran-Mantel-Haenszel||||
1731349|NCT00545740|3187924|Superiority or Other|||||||0.741|||||||Cochran-Mantel-Haenszel||||
1731350|NCT00545740|3187924|Superiority or Other|||||||0.047|||||||Cochran-Mantel-Haenszel||||
1731351|NCT00545740|3187926|Superiority or Other|||||||0.78|||||||Cochran-Mantel-Haenszel||||
1731352|NCT00545740|3187926|Superiority or Other|||||||0.736|||||||Cochran-Mantel-Haenszel||||
1731353|NCT00545740|3187926|Superiority or Other|||||||0.063|||||||Cochran-Mantel-Haenszel||||
1731354|NCT00545688|3187941|Superiority or Other||Hazard Ratio (HR)|2.16||||0.025|2-Sided|95.0|1.08|4.32|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS|
1731355|NCT00545688|3187941|Superiority or Other||Hazard Ratio (HR)|0.83||||0.5901|2-Sided|95.0|0.42|1.64|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS|
1731356|NCT00545688|3187941|Superiority or Other||Hazard Ratio (HR)|0.6||||0.1805|2-Sided|95.0|0.28|1.27|||Cochran-Mantel-Haenszel||HR is based on Cox proportional hazard regression stratified by breast cancer type and hormone positivity.|DFS|
1736196|NCT00486902|3196412|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)||||
1731361|NCT00545688|3187956|Superiority or Other||Difference in Response rates|-21.84||||0.001|2-Sided|95.0|-35.1|-8.5||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel||||
1731362|NCT00545688|3187956|Superiority or Other|||||||0.0198||||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel||||
1731363|NCT00545688|3187956|Superiority or Other||Difference in Response rates|-12.15||||0.0198|2-Sided|95.0|-23.8|-0.5||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel||||
1731364|NCT00545688|3187956|Superiority or Other|||||||0.0141||||||P-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.|Cochran-Mantel-Haenszel||||
1731365|NCT00545688|3187956|Superiority or Other||Difference in Response rates|16.82||||0.0094|2-Sided|95.0|3.5|30.1||Cochran-Mantel-Haenszel test stratified by breast cancer type (operable, locally advanced, or inflammatory) and estrogen and or progesterone positivity (either positive versus both negative).|Cochran-Mantel-Haenszel||||
1731366|NCT00545662|3187957|Superiority or Other||Odds Ratio (OR)|0.98||||0.76|2-Sided|95.0|0.83|1.14||a priori threshold for statistical significance is 0.05|Regression, Logistic|Logistic regression estimated global OR. GEE accounted for correlations of the scales. Models adjusted for site & injury severity.|The odds in the citicoline group were compared to the odds in the placebo group.|"Null hypothesis: The placebo and citicoline groups do not differ at 90-days on the Core Battery~Power:~Two sided type I error of 0.05~85% power~Expected OR=1.40 for the global statistic~Response rate in the control group~Correlations among the nine measures were accounted for. Response rates for the whole sample were a weighted average of the rates provided by TBI severity.~1240 participants were required to detect an OR >= 1.4 for the global statistic."|
1731367|NCT00545441|3188018|Non-Inferiority or Equivalence|Alpha = 0.05 and power = 0.8, a non-inferiority margin of 10%.||||||0.59|||||||Fisher Exact||||
1731368|NCT00545402|3188021|Superiority or Other|||||||0.7091|||||||Log Rank||||
1731369|NCT00545402|3188023|Superiority or Other|||||||0.2611|||||||Log Rank||||
1731370|NCT00545363|3188025|Superiority or Other||||||=|0|||||||ANOVA|||Statistical analysis was done to compare the effect of adherence (Yes/No) on percent change from baseline in CTX between the Biofeedback and No-feedback arms.|
1731371|NCT00545363|3188026|Superiority or Other||||||=|0|||||||ANOVA|||Statistical analysis was done to compare the participant perception between the Biofeedback and No-feedback arms.|
1731372|NCT00545363|3188027|Superiority or Other||||||=|0|||||||ANOVA|||Statistical analysis was done to compare the participant satisfaction between the Biofeedback and No-feedback arms.|
1731373|NCT00545181|3188060|Superiority or Other|||||||0.75|||||||Chi-squared, Corrected||||
1731374|NCT00545103|3188078|Superiority or Other|||||||0.441|||||||Cochran-Mantel-Haenszel||||
1731375|NCT00545103|3188078|Superiority or Other|||||||0.198|||||||Cochran-Mantel-Haenszel||||
1731376|NCT00545103|3188078|Superiority or Other|||||||0.685|||||||Cochran-Mantel-Haenszel||||
1731377|NCT00545103|3188079|Superiority or Other|||||||0.368|||||||Cochran-Mantel-Haenszel||||
1731378|NCT00545103|3188079|Superiority or Other|||||||0.159|||||||Cochran-Mantel-Haenszel||||
1731379|NCT00545103|3188079|Superiority or Other|||||||0.778|||||||Cochran-Mantel-Haenszel||||
1731380|NCT00545064|3188086|Superiority or Other||Median Difference (Net)|-11.5|Standard Deviation|5.3|<|0.001||95.0|-12.3|-10.7|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in IOP = 0"|
1731381|NCT00545064|3188086|Superiority or Other||Mean Difference (Net)|-11.5|Standard Deviation|5.3|<|0.001||95.0|-12.3|-10.7|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in IOP = -4"|
1731382|NCT00545064|3188089|Superiority or Other||Mean Difference (Net)|3.2|Standard Deviation|20.2||0.097||95.0|-0.6|7.0|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in GSS-SYMP-6 = 0"|
1731383|NCT00545064|3188089|Superiority or Other||Mean Difference (Net)|3.2|Standard Deviation|20.2||0.001||95.0|-0.6|7.0|||t-test, 2 sided|||"The change is the post-baseline value minus the baseline value.~Null Hypothesis: change in GSS-SYMP-6 score = 7"|
1731384|NCT00545051|3188091|Superiority or Other||||||<|0.001|||||||ANCOVA|||TRACP at Month 12|
1731385|NCT00545051|3188091|Superiority or Other||||||<|0.001|||||||ANCOVA|||TRACP at Month 6|
1731386|NCT00545051|3188091|Superiority or Other||||||<|0.001|||||||ANCOVA|||TRACP at Month 1|
1731387|NCT00545051|3188091|Superiority or Other||||||<|0.001|||||||ANCOVA|||P1NP at Month 12|
1731388|NCT00545051|3188091|Superiority or Other||||||<|0.001|||||||ANCOVA|||P1NP at Month 6|
1731389|NCT00545051|3188091|Superiority or Other||||||<|0.001|||||||ANCOVA|||P1NP at Month 1|
1731390|NCT00545051|3188091|Superiority or Other||||||<|0.001|||||||ANCOVA|||sCTX at Month 12|
1731391|NCT00545051|3188091|Superiority or Other||||||<|0.001|||||||ANCOVA|||sCTX at Month 6|
1731392|NCT00545051|3188091|Superiority or Other||||||<|0.001|||||||ANCOVA|||sCTX at Month 1|
1731393|NCT00545051|3188092|Superiority or Other||Mean Difference (Final Values)|1.81|||<|0.001|2-Sided|95.0|0.96|2.66|||ANCOVA|||Month 12|
1731394|NCT00545051|3188092|Superiority or Other||Mean Difference (Final Values)|0.55|||<|0.122|2-Sided|95.0|-0.15|1.25|||ANCOVA|||Month 6|
1731395|NCT00545051|3188093|Superiority or Other||Mean Difference (Final Values)|2.22|||<|0.001|2-Sided|95.0|1.22|3.23|||ANCOVA||||
1731396|NCT00545051|3188094|Superiority or Other||Mean Difference (Final Values)|3.25|||<|0.001|2-Sided|95.0|2.09|4.41|||ANCOVA||||
1731397|NCT00544882|3188110|Superiority or Other|||||||0.3703|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.|
1731398|NCT00544882|3188110|Superiority or Other|||||||0.7811|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 -Day 4 time point.|
1731399|NCT00544882|3188110|Superiority or Other|||||||0.9262|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.|
1731400|NCT00544882|3188110|Superiority or Other|||||||0.8829|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 28 time point.|
1731404|NCT00544882|3188110|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.|
1731405|NCT00544882|3188110|Superiority or Other|||||||0.6316|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.|
1731406|NCT00544882|3188110|Superiority or Other|||||||0.8464|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.|
1731407|NCT00544882|3188110|Superiority or Other|||||||0.0629|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.|
1731408|NCT00544882|3188110|Superiority or Other|||||||0.0979|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values < 0.05 were considered statistically significant.|
1731409|NCT00544882|3188111|Superiority or Other|||||||0.9226|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.|
1731410|NCT00544882|3188111|Superiority or Other|||||||0.6675|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 4 time point.|
1731411|NCT00544882|3188111|Superiority or Other|||||||0.1918|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.|
1731412|NCT00544882|3188111|Superiority or Other|||||||0.3772|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 28 time point.|
1731413|NCT00544882|3188111|Superiority or Other|||||||0.8445|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.|
1731414|NCT00544882|3188111|Superiority or Other|||||||0.6675|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 25 time point.|
1731415|NCT00544882|3188111|Superiority or Other|||||||0.4122|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.|
1731416|NCT00544882|3188111|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.|
1731417|NCT00544882|3188111|Superiority or Other|||||||0.8083|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.|
1731418|NCT00544882|3188111|Superiority or Other|||||||0.5782|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.|
1731419|NCT00544882|3188111|Superiority or Other|||||||0.7678|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.|
1731420|NCT00544882|3188111|Superiority or Other|||||||0.8892|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values < 0.05 were considered statistically significant.|
1731421|NCT00544882|3188113|Superiority or Other|||||||0.8841|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 6 time point.|
1731422|NCT00544882|3188113|Superiority or Other|||||||0.4003|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 4 time point.|
1731423|NCT00544882|3188113|Superiority or Other|||||||0.6252|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 3 - Day 2 time point.|
1731424|NCT00544882|3188113|Superiority or Other|||||||0.2485|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 28 time point.|
1731425|NCT00544882|3188113|Superiority or Other|||||||0.4526|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 27 time point.|
1731426|NCT00544882|3188113|Superiority or Other|||||||0.4829|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 25 time point.|
1731427|NCT00544882|3188113|Superiority or Other|||||||0.7891|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 24 time point.|
1731428|NCT00544882|3188113|Superiority or Other|||||||0.394|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 23 time point.|
1731429|NCT00544882|3188113|Superiority or Other|||||||0.5543|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Days 19-20 time point.|
1731430|NCT00544882|3188113|Superiority or Other|||||||0.1321|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 6 time point.|
1731431|NCT00544882|3188113|Superiority or Other|||||||0.2757|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 4 time point.|
1731432|NCT00544882|3188113|Superiority or Other|||||||0.6346|||||||Wilcoxon (Mann-Whitney)|||Comparison of treatment groups at Cycle 2 - Day 2 time point. p-values < 0.05 were considered statistically significant.|
1731433|NCT00544544|3188176|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1731434|NCT00544544|3188177|Superiority or Other|||||||0.38|||||||Mixed Models Analysis||||
1731435|NCT00544544|3188178|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1731436|NCT00544544|3188179|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1731437|NCT00544076|3188185|Other||Mean Difference (Final Values)|0.08||||0.08|2-Sided|||||no adjustments|ANOVA|no adjustments for df||"ANOVA test to compare difference of penile length (from baseline to month 18) across arms.~calculations are underpowered, as study did not accrue or retain patients as intended, and many patients declined to have measurements taken."|
1731438|NCT00544076|3188186|Other||||||>|0.2||||||no adjustments done.|ANOVA||||
1731439|NCT00544076|3188187|Other||||||>|0.1||||||no adjustments done|Chi-squared|no adjustments||compare percentage of patients potent at 6 and 18 months across pairs of treatment arms (arm I vs arm II, arm I vs arm III, arm II vs arm III)|
1731440|NCT00544076|3188188|Equivalence|The equivalence margin that would be possible to detect (had the protocol reached intended accrual) was 20%,|||||>|0.1||||||no adjustments were made.|Fisher Exact||||
1731441|NCT00543985|3188192|Superiority or Other||Pearson correlation coefficient|-0.266|||=|0|2-Sided|95.0|||||Regression, Linear|||Pearson Product correlation was used to determine relationships between resting E/E' and Exercise VO2 max and Stress E/E' and Exercise VO2max.|
1731442|NCT00543725|3188216|Non-Inferiority or Equivalence|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 – EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|0.7|||<|0.0001||95.0|-5.6|7.0|||Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.||
1731443|NCT00543725|3188217|Non-Inferiority or Equivalence|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 – EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|2.4|||<|0.0001||95.0|-3.6|8.4||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.|
1731444|NCT00543725|3188218|Non-Inferiority or Equivalence|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 – EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|3.9|||<|0.0001||95.0|-1.9|9.6|||Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.||
1731445|NCT00543725|3188219|Non-Inferiority or Equivalence|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 – EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|3.7|||<|0.0001||95.0|-1.6|9.0||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm and background NRTI regimen as factors, and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.|
1731446|NCT00543569|3188222|Superiority or Other||Difference|-0.8|||||2-Sided|90.0|-13.3|11.7||||||Treatment Failure at Month 12|
1731447|NCT00543569|3188222|Superiority or Other||Difference|9.7|||||2-Sided|90.0|-3.3|22.8||||||Treatment Failure at Month 12|
1731448|NCT00543569|3188222|Superiority or Other||Difference|10.0|||||2-Sided|90.0|-2.9|22.8||||||Treatment Failure at Month 12|
1731449|NCT00543569|3188222|Superiority or Other||Difference|2.9|||||2-Sided|90.0|-8.9|14.7||||||Treatment Failure at Month 6|
1731450|NCT00543569|3188222|Superiority or Other||Difference|11.8|||||2-Sided|90.0|-0.7|24.2||||||Treatment Failure at Month 6|
1731451|NCT00543569|3188222|Superiority or Other||Difference|11.1|||||2-Sided|90.0|-1.1|23.3||||||Treatment Failure at Month 6|
1731452|NCT00543569|3188232|Superiority or Other||Difference|6.7|||||2-Sided|90.0|-4.2|17.6||||||Efficacy Failure at Month 12|
1731453|NCT00543569|3188232|Superiority or Other||Difference|2.3|||||2-Sided|90.0|-8.3|13.0||||||Efficacy Failure at Month 12|
1731454|NCT00543569|3188232|Superiority or Other||Difference|7.0|||||2-Sided|90.0|-4.0|18.0||||||Efficacy Failure at Month 12|
1731455|NCT00543569|3188232|Superiority or Other||Difference|9.1|||||2-Sided|90.0|-0.4|18.7||||||Efficacy Failure at Month 6|
1731456|NCT00543569|3188232|Superiority or Other||Difference|4.6|||||2-Sided|90.0|-4.5|13.7||||||Efficacy Failure at Month 6|
1731457|NCT00543569|3188232|Superiority or Other||Difference|10.7|||||2-Sided|90.0|0.9|20.4||||||Efficacy Failure at Month 6|
1731458|NCT00543569|3188233|Superiority or Other||Difference|4.2|||||2-Sided|90.0|-7.5|15.9||||||Efficacy Failure at Month12|
1731459|NCT00543569|3188233|Superiority or Other||Difference|4.0|||||2-Sided|90.0|-7.8|15.8||||||Efficacy Failure at Month 12|
1731460|NCT00543569|3188233|Superiority or Other||Difference|8.4|||||2-Sided|90.0|-3.5|20.4||||||Efficacy Failure at Month12|
1731461|NCT00543569|3188233|Superiority or Other||Difference|7.9|||||2-Sided|90.0|-2.4|18.2||||||Efficacy Failure at Month 6|
1731462|NCT00543569|3188233|Superiority or Other||Difference|7.5|||||2-Sided|90.0|-2.9|17.8||||||Efficacy Failure at Month 6|
1731463|NCT00543569|3188233|Superiority or Other||Difference|14.7|||||2-Sided|90.0|3.8|25.5||||||Efficacy Failure at Month 6|
1731464|NCT00543569|3188237|Superiority or Other||Difference|7.8|||||2-Sided|90.0|-0.6|16.2||||||T-cell Mediated BCAR at Month 12|
1731465|NCT00543569|3188237|Superiority or Other||Difference|4.3|||||2-Sided|90.0|-3.6|12.3||||||T-cell Mediated BCAR at Month 12|
1731466|NCT00543569|3188237|Superiority or Other||Difference|10.7|||||2-Sided|90.0|1.8|19.5||||||T-cell Mediated BCAR at Month 12|
1731467|NCT00543569|3188237|Superiority or Other||Difference|6.4|||||2-Sided|90.0|-1.7|14.6||||||T-cell Mediated BCAR at Month 6|
1731468|NCT00543569|3188237|Superiority or Other||Difference|4.3|||||2-Sided|90.0|-3.6|12.3||||||T-cell Mediated BCAR at Month 6|
1731469|NCT00543569|3188237|Superiority or Other||Difference|9.3|||||2-Sided|90.0|0.7|18.0||||||T-cell Mediated BCAR at Month 6|
1731470|NCT00543569|3188238|Superiority or Other||Difference|4.1|||||2-Sided|90.0|-5.6|13.8||||||T-cell Mediated BCAR at Month 12|
1731471|NCT00543569|3188238|Superiority or Other||Difference|4.8|||||2-Sided|90.0|-5.1|14.6||||||T-cell Mediated BCAR at Month 12|
1731472|NCT00543569|3188238|Superiority or Other||Difference|13.6|||||2-Sided|90.0|3.0|24.3||||||T-cell Mediated BCAR at Month 12|
1731473|NCT00543569|3188238|Superiority or Other||Difference|4.0|||||2-Sided|90.0|-5.3|13.3||||||T-cell Mediated BCAR at Month 6|
1731474|NCT00543569|3188238|Superiority or Other||Difference|6.1|||||2-Sided|90.0|-3.6|15.8||||||T-cell Mediated BCAR at Month 6|
1731475|NCT00543569|3188238|Superiority or Other||Difference|12.2|||||2-Sided|90.0|2.0|22.5||||||T-cell Mediated BCAR at Month 6|
1731476|NCT00543569|3188239|Superiority or Other||Difference|7.8|||||2-Sided|90.0|-0.6|16.2||||||BCAR at Month 12|
1731477|NCT00543569|3188239|Superiority or Other||Difference|4.3|||||2-Sided|90.0|-3.6|12.3||||||BCAR at Month 12|
1731478|NCT00543569|3188239|Superiority or Other||Difference|12.0|||||2-Sided|90.0|3.0|21.0||||||BCAR at Month 12|
1731488|NCT00543569|3188241|Superiority or Other||Difference|-3.9|||||2-Sided|90.0|-10.0|2.2||||||Graft survival at 6 months|
1731489|NCT00543569|3188241|Superiority or Other||Difference|-0.2|||||2-Sided|90.0|-5.3|4.9||||||Graft survival at 6 months|
1731490|NCT00543569|3188241|Superiority or Other||Difference|-2.7|||||2-Sided|90.0|-8.5|3.1||||||Graft survival at 6 months|
1731491|NCT00543569|3188242|Superiority or Other||Difference|2.4|||||2-Sided|90.0|-6.0|10.8||||||Patient survival at 12 months|
1731492|NCT00543569|3188242|Superiority or Other||Difference|0.5|||||2-Sided|90.0|-8.3|9.2||||||Patient survival at 12 months|
1731493|NCT00543569|3188242|Superiority or Other||Difference|4.9|||||2-Sided|90.0|-3.1|12.8||||||Patient survival at 12 months|
1731494|NCT00543569|3188242|Superiority or Other||Difference|-2.6|||||2-Sided|90.0|-8.4|3.2||||||Patient survival at 6 months|
1731495|NCT00543569|3188242|Superiority or Other||Difference|1.1|||||2-Sided|90.0|-3.5|5.8||||||Patient survival at 6 months|
1731496|NCT00543569|3188242|Superiority or Other||Difference|-1.4|||||2-Sided|90.0|-6.9|4.1||||||Patient survival at 6 months|
1731497|NCT00543569|3188243|Non-Inferiority or Equivalence|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|4.0|||||2-Sided|90.0|-5.3|13.3|||||A positive difference indicated a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).||
1731498|NCT00543569|3188243|Non-Inferiority or Equivalence|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|6.1|||||2-Sided|90.0|-3.6|15.8|||||A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).||
1731499|NCT00543569|3188243|Non-Inferiority or Equivalence|The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.|Difference|13.6|||||2-Sided|90.0|3.2|23.9|||||A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).||
1731500|NCT00543543|3188247|Superiority or Other||Vaccine efficacy|96.0|||||2-Sided|95.0|94.6|97.1|||||Vaccine efficacy = 100 * [1 - (incidence rate with V503 / incidence rate with Gardasil)]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of >25%.||
1731501|NCT00543543|3188254|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was >0.67|GMT ratio|1.19|||<|0.001|2-Sided|95.0|1.14|1.23|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 18|
1731502|NCT00543543|3188254|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was >0.67|GMT ratio|0.99|||<|0.001|2-Sided|95.0|0.96|1.03|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 16|
1731503|NCT00543543|3188254|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the two-sided CI of the GMT ratio was >0.67|GMT ratio|0.8|||<|0.001|2-Sided|95.0|0.77|0.83|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 11|
1731504|NCT00543543|3188254|Non-Inferiority or Equivalence|Non-inferiority required that the lower bound of the two-sided confidence interval (CI) of the GMT ratio was >0.67|GMT ratio|1.02|||<|0.001|2-Sided|95.0|0.99|1.06|||ANOVA||GMT ratio = GMT (V503) / GMT (Gardasil)|Anti-HPV Type 6|
1731505|NCT00543543|3188255|Superiority or Other||Vaccine efficacy|97.4|||||2-Sided|95.0|85.0|99.9|||||Vaccine efficacy = 100 * [1 - (incidence rate with V503 / incidence rate with Gardasil)]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of >25%.||
1731506|NCT00543543|3188256|Superiority or Other||Vaccine efficacy|96.7|||<|0.0001|2-Sided|95.0|80.9|99.8|||Exact test, 1-sided||Vaccine efficacy = 100 * [1 - (incidence rate with V503 / incidence rate with Gardasil)]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of >25%.||
1731507|NCT00543439|3188278|Equivalence|90% 2-sided CI for the mean difference in ABRs for the 2 prophylaxis regimens for ITT participants was constructed using the t distribution with n-1 degrees of freedom (n equals the number of participants) to assess the equivalence of the 2 regimens. Equivalence was demonstrated and the null hypothesis rejected if the limits of the 90% CI fell wholly within the interval of (–4, 4) bleeds per year.|Mean Difference (Final Values)|1.1|||||2-Sided|90.0|0.03|2.22|||||||
1731508|NCT00543439|3188279|Superiority||Ratio of arithmetic means|0.03||||0.002|1-Sided|95.0||0.08|||Paired t-test|||Ratio of the arithmetic means of the ABR for OD cohort: OD therapy to OD cohort: RP therapy 25 IU/kg was calculated. One-sided 95% CI for this ratio was reported.|
1731509|NCT00543140|3188306|Superiority or Other|||||||0.6919||||||No adjustments for multiple comparisons were performed as only one hypothesis was tested in this study. The level of significance was set at 0.05.|Exact Binomial method|||The primary analysis used a one-sided binomial exact test method by Clopper and Pearson to determine if the rate of reoperations observed in Years 4 and 5 (combined) of the study was significantly less than 8%. The null hypothesis was that the reoperation rate was greater than or equal to 8%.|
1731510|NCT00542620|3188375|Superiority or Other|||||||0.665|||||||ANCOVA|With adjustment on baseline value|||
1731511|NCT00542620|3188376|Superiority or Other|||||||0.202|||||||ANCOVA|With adjustment on baseline value|||
1731512|NCT00542620|3188377|Superiority or Other|||||||0.439|||||||ANCOVA|With adjustment on baseline value|||
1731513|NCT00542620|3188378|Superiority or Other|||||||0.023|||||||ANCOVA|With adjustment on baseline value|||
1731514|NCT00542620|3188379|Superiority or Other|||||||0.166|||||||ANCOVA|With adjustment on baseline value|||
1731515|NCT00542620|3188380|Superiority or Other|||||||0.1|||||||ANCOVA|With adjustment on baseline value|||
1731516|NCT00542620|3188381|Superiority or Other|||||||0.127|||||||ANCOVA|With adjustment on baseline value|||
1731517|NCT00542620|3188384|Superiority or Other|||||||0.471|||||||ANCOVA|With adjustment on baseline value|||
1731518|NCT00542620|3188385|Superiority or Other|||||||0.411|||||||ANCOVA|With adjustment on baseline value|||
1731519|NCT00542620|3188386|Superiority or Other|||||||0.727|||||||ANCOVA|With adjustment on baseline value|||
1731520|NCT00542620|3188387|Superiority or Other|||||||0.722|||||||ANCOVA|With adjustment on baseline value|||
1731521|NCT00542620|3188388|Superiority or Other|||||||0.534|||||||ANCOVA|With adjustment on baseline value|||
1731522|NCT00542620|3188389|Superiority or Other|||||||0.234|||||||ANCOVA|With adjustment for baseline value|||
1731523|NCT00542620|3188390|Superiority or Other|||||||0.22|||||||ANCOVA|With adjustment on baseline value|||
1731524|NCT00542620|3188391|Superiority or Other|||||||0.209|||||||ANCOVA|With adjustment on baseline value|||
1731525|NCT00542620|3188392|Superiority or Other|||||||0.917|||||||ANCOVA|With adjustment on baseline value|||
1731526|NCT00542620|3188393|Superiority or Other|||||||0.856|||||||ANCOVA|With adjustment on baseline value|||
1731527|NCT00542620|3188394|Superiority or Other|||||||0.389|||||||ANCOVA|With adjustment on baseline value|||
1731528|NCT00542620|3188395|Superiority or Other|||||||0.063|||||||ANCOVA|With adjustment on baseline value|||
1731529|NCT00542620|3188396|Superiority or Other||Mean Difference (Final Values)|-8.35|Standard Error of the Mean|14.59||0.573||95.0|-38.77|22.08|||ANCOVA|With adjustment on baseline fructosamine and the change in insulin administration mode|||
1731530|NCT00542620|3188397|Non-Inferiority or Equivalence|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D>0.25% against HA: D=<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).|Mean Difference (Final Values)|-0.594||||0.003||95.0|-0.97|-0.219||If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated.|ANCOVA|Baseline HbA1c as covariate.|||
1731531|NCT00542620|3188398|Non-Inferiority or Equivalence|Non-inferiority was considered confirmed if the upper bound of the two-sided 95% confidence interval was below or equal to 0.25% or equivalently if the p-value for the one-sided test of H0: D>0.25% against HA: D=<0.25%, was less than or equal to 2.5%, where D is the mean treatment difference (mixing injections minus separate injections).|Median Difference (Final Values)|-0.691||||0.001||95.0|-1.049|-0.334||If non-inferiority was confirmed, the superiority of the mixed injection group over separate injection group was to be investigated|ANCOVA|Baseline HbA1c as covariate|||
1731532|NCT00542425|3188405|Superiority or Other||||||<|0.001|||||||ANOVA|||For the BMD endpoint, the planned study size has 80 percent power with alpha=0.02 to detect a difference in mean change from baseline of 3.0 (percent) in BMD for the BA058 group and the BA058 Placebo group using an assumed SD of 3.5-4.0. The estimates for SD are based upon results of lumbar spine BMD presented by Body 2002.|
1731533|NCT00542425|3188405|Superiority or Other||||||<|0.001|||||||ANOVA|||For the BMD endpoint, the planned study size has 80 percent power with alpha=0.02 to detect a difference in mean change from baseline of 3.0 (percent) in BMD for the BA058 group and the BA058 Placebo group using an assumed SD of 3.5-4.0. The estimates for SD are based upon results of lumbar spine BMD presented by Body 2002.|
1731534|NCT00542425|3188406|Superiority or Other||||||<|0.001|||||||ANOVA|||Study size provided 95 percent power to detect a difference in means of 114 (ng/mL) for PINP endpoint between BA058 (SD=147.5) and placebo (SD=34.5). Study size was based on Bauer 2006 data and utilized a 2-tailed 2-sample t-test with a significance level of alpha=0.01 with a Bonferonni adjustment for multiple testing. It included a 10 percent adjustment for within study dropouts over 6 months and a 15 percent adjustment to maintain adequate power for a per protocol analysis of key endpoints.|
1731535|NCT00542425|3188406|Superiority or Other||||||<|0.001|||||||ANOVA|||Study size provided 95 percent power to detect a difference in means of 114 (ng/mL) for PINP endpoint between BA058 (SD=147.5) and placebo (SD=34.5). Study size was based on Bauer 2006 data and utilized a 2-tailed 2-sample t-test with a significance level of alpha=0.01 with a Bonferonni adjustment for multiple testing. It included a 10 percent adjustment for within study dropouts over 6 months and a 15 percent adjustment to maintain adequate power for a per protocol analysis of key endpoints.|
1731536|NCT00542321|3188416|Superiority or Other||Rank sums|56.0||||1|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1731537|NCT00542321|3188417|Superiority or Other||probability|0.43||||1||95.0|||||Fisher Exact||||
1731538|NCT00542321|3188418|Superiority or Other|||||||0.451|||||||Wilcoxon (Mann-Whitney)||||
1731539|NCT00542321|3188419|Superiority or Other||Rank sums|52.0||||1|2-Sided|95.0||||Alpha = .05|Wilcoxon (Mann-Whitney)|||There will be no difference in duration of mechanical ventilation between groups.|
1731540|NCT00542321|3188420|Superiority or Other||difference between proportions|0.5||||1|2-Sided|95.0|||||Fisher Exact|Chi-Square = 0.750, df = 1||Pearson Chi-Square Test for difference between groups|
1731541|NCT00542178|3188434|Superiority or Other||Odds Ratio (OR)|1.09||||0.78|2-Sided|95.0|0.6|1.96|||Regression, Logistic||||
1731542|NCT00542178|3188434|Superiority or Other||Odds Ratio (OR)|0.85||||0.63|2-Sided|95.0|0.44|1.63|||Regression, Logistic||||
1731543|NCT00542178|3188434|Superiority or Other||Odds Ratio (OR)|1.09||||0.069|2-Sided|95.0|0.71|1.69|||Regression, Logistic||||
1731544|NCT00542178|3188435|Superiority or Other||Hazard Ratio (HR)|1.015||||0.86|2-Sided|95.0|0.865|1.19|||Regression, Cox||||
1731545|NCT00542178|3188435|Superiority or Other||Hazard Ratio (HR)|0.891||||0.17|2-Sided|95.0|0.755|1.051|||Regression, Cox||||
1731546|NCT00542178|3188435|Superiority or Other||Hazard Ratio (HR)|0.884||||0.0355|2-Sided|95.0|0.788|0.992|||Regression, Cox||||
1731547|NCT00542178|3188436|Superiority or Other||Hazard Ratio (HR)|0.88||||0.08|2-Sided|95.0|0.762|1.016|||Regression, Cox||||
1731548|NCT00542178|3188436|Superiority or Other||Hazard Ratio (HR)|0.952||||0.5|2-Sided|95.0|0.825|1.099|||Regression, Cox||||
1731549|NCT00542178|3188436|Superiority or Other||Hazard Ratio (HR)|0.997||||0.96|2-Sided|95.0|0.901|1.104|||Regression, Cox||||
1731682|NCT00540449|3188625|Non-Inferiority or Equivalence|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 – EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-1.7||||0.0013||95.0|-8.0|4.5|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|||
1731550|NCT00542178|3188437|Superiority or Other||Odds Ratio (OR)|0.6||||0.006|2-Sided|95.0|0.42|0.87|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 91% to detect a 20% relative reduction with lipid control with a statin and fenofibrate as compared with lipid control with a statin alone|
1731551|NCT00542178|3188437|Superiority or Other||Odds Ratio (OR)|1.23||||0.29|2-Sided|95.0|0.84|1.79|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 80% to detect a 20% relative reduction with intensive blood pressure control as compared with standard blood pressure control|
1731552|NCT00542178|3188437|Superiority or Other||Odds Ratio (OR)|0.67||||0.003|2-Sided|95.0|0.51|0.87|||Regression, Logistic|Comparisons made using likelihood-ratio tests from logistic-regression models with adjustment for same study-design factors used in ACCORD analysis||Our recruitment goal for the ACCORD Eye study was set in order to achieve a statistical power of 88% to detect a 15% relative reduction with intensive glycemic control as compared with standard glycemic control|
1731553|NCT00541775|3188481|Superiority or Other||Mean Difference (Net)|-30.5|Standard Error of the Mean|7.9|<=|0||95.0|-46.0|-15.0|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.|||
1731554|NCT00541775|3188482|Superiority or Other||Mean Difference (Net)|-17.8|Standard Error of the Mean|5.0|<=|0||95.0|-27.6|-8.1|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.|||
1731555|NCT00541775|3188483|Superiority or Other||Mean Difference (Net)|-0.51|Standard Error of the Mean|0.1|<=|0||95.0|-0.7|-0.32|||ANCOVA|Analysis of covariance with a term for treatment, and a covariate for baseline value.|||
1731556|NCT00541658|3188485|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.2||||0.7719|2-Sided|95.0|0.37|3.9|||Fisher Exact||||
1731557|NCT00541658|3188485|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.41||||0.4505|2-Sided|95.0|0.08|2.11|||Fisher Exact||||
1731558|NCT00541658|3188486|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.82||||1|2-Sided|95.0|0.22|3.03|||Fisher Exact||||
1731559|NCT00541658|3188486|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.42||||0.4505|2-Sided|95.0|0.08|2.14|||Fisher Exact||||
1731560|NCT00541658|3188487|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.49||||1|2-Sided|95.0|0.25|8.87|||Fisher Exact||||
1731561|NCT00541658|3188487|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.03||||1|2-Sided|95.0|0.15|7.29|||Fisher Exact||||
1731562|NCT00541658|3188488|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.5||||1|2-Sided|95.0|0.25|8.9|||Fisher Exact||||
1731563|NCT00541658|3188488|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.0||||1|2-Sided|95.0|0.14|7.05|||Fisher Exact||||
1731680|NCT00540514|3188618|Superiority or Other (legacy)||Hazard Ratio (HR)|0.902||||0.214|2-Sided|95.1|0.767|1.06||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (squamous cell carcinoma, adenocarcinoma, or other carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) <1 favors the albumin-bound paclitaxel/carboplatin group.||
1731564|NCT00541658|3188489|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.2||||0.7719|2-Sided|95.0|0.37|3.9|||Fisher Exact||||
1731565|NCT00541658|3188489|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.41||||0.4505|2-Sided|95.0|0.08|2.11|||Fisher Exact||||
1731566|NCT00541658|3188490|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.82||||1|2-Sided|95.0|0.22|3.03|||Fisher Exact||||
1731567|NCT00541658|3188490|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|0.42||||0.4505|2-Sided|95.0|0.08|2.14|||Fisher Exact||||
1731568|NCT00541658|3188491|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.49||||1|2-Sided|95.0|0.25|8.87|||Fisher Exact||||
1731569|NCT00541658|3188491|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.03||||1|2-Sided|95.0|0.15|7.29|||Fisher Exact||||
1731570|NCT00541658|3188492|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.5||||1|2-Sided|95.0|0.25|8.9|||Fisher Exact||||
1731571|NCT00541658|3188492|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.0||||1|2-Sided|95.0|0.14|7.05|||Fisher Exact||||
1731572|NCT00541658|3188493|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.251|||||2-Sided|95.0|-1.248|5.751|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731573|NCT00541658|3188493|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.197|||||2-Sided|95.0|-1.318|5.711|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731574|NCT00541658|3188494|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.416|||||2-Sided|95.0|-0.255|7.087|||||LS Mean Difference is 5 mg daily minus daily treatment.||
1731575|NCT00541658|3188494|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|2.749|||||2-Sided|95.0|-0.938|6.436|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731814|NCT00537940|3188990|Superiority or Other|||||||0.4203||||||SGTC seizure: p-value was calculated from the 2-sided Fisher’s exact test.|Fisher Exact||||
1731576|NCT00541658|3188495|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.462|||||2-Sided|95.0|-1.611|4.535|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731577|NCT00541658|3188495|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.434|||||2-Sided|95.0|-1.652|4.521|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731578|NCT00541658|3188496|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.612|||||2-Sided|95.0|-1.556|4.779|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731579|NCT00541658|3188496|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.555|||||2-Sided|95.0|-1.617|4.727|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731580|NCT00541658|3188497|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.309|||||2-Sided|95.0|-1.576|4.194|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731581|NCT00541658|3188497|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.407|||||2-Sided|95.0|-0.502|5.316|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731582|NCT00541658|3188498|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.805|||||2-Sided|95.0|-1.087|4.698|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731583|NCT00541658|3188498|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|1.755|||||2-Sided|95.0|-1.145|4.655|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731584|NCT00541658|3188499|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.301|||||2-Sided|95.0|0.911|13.69|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731585|NCT00541658|3188499|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.802|||||2-Sided|95.0|1.385|14.22|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731586|NCT00541658|3188500|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|8.383|||||2-Sided|95.0|1.757|15.01|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731683|NCT00540449|3188626|Non-Inferiority or Equivalence|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 – EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-3.2||||0.0055||95.0|-9.4|3.1|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.||
1731587|NCT00541658|3188500|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|7.83|||||2-Sided|95.0|1.175|14.485|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731588|NCT00541658|3188501|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.531|||||2-Sided|95.0|0.164|10.897|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731589|NCT00541658|3188501|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|6.552|||||2-Sided|95.0|1.162|11.942|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731590|NCT00541658|3188502|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.638||||||95.0|0.356|10.92|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731591|NCT00541658|3188502|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.775|||||2-Sided|95.0|-0.514|10.065|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731592|NCT00541658|3188503|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.972|||||2-Sided|95.0|0.02|9.924|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731593|NCT00541658|3188503|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.798|||||2-Sided|95.0|-0.195|9.79|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731594|NCT00541658|3188504|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|3.723|||||2-Sided|95.0|-0.975|8.421|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731595|NCT00541658|3188504|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.45|||||2-Sided|95.0|-0.26|9.16|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731596|NCT00541658|3188505|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.192|||||2-Sided|95.0|-2.295|8.68|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731597|NCT00541658|3188505|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|4.817|||||2-Sided|95.0|-0.693|10.327|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731684|NCT00540449|3188627|Non-Inferiority or Equivalence|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 – EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|0.3|||<|0.0001||95.0|-5.4|5.9|||Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.||
1731598|NCT00541658|3188506|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|3.999|||||2-Sided|95.0|-1.518|9.515|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731599|NCT00541658|3188506|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|4.739|||||2-Sided|95.0|-0.793|10.271|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731600|NCT00541658|3188507|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.403|||||2-Sided|95.0|-0.619|9.425|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731601|NCT00541658|3188507|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|6.372|||||2-Sided|95.0|1.329|11.414|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731602|NCT00541658|3188508|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.64|||||2-Sided|95.0|-0.293|9.574|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731603|NCT00541658|3188508|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|5.04|||||2-Sided|95.0|0.091|9.989|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731604|NCT00541658|3188509|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|4.617|||||2-Sided|95.0|-0.152|9.386|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731605|NCT00541658|3188509|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.63|||||2-Sided|95.0|-2.171|7.431|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731606|NCT00541658|3188510|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|2.826|||||2-Sided|95.0|-1.819|7.471|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731607|NCT00541658|3188510|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|3.771|||||2-Sided|95.0|-0.885|8.427|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731608|NCT00541658|3188511|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.056|||||2-Sided|95.0|-1.787|-0.326|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731710|NCT00540124|3188691|Superiority or Other|||||||0.921||||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel||||
1731815|NCT00537940|3188990|Superiority or Other|||||||0.9075||||||Complex partial: p-value was calculated from the 2-sided Fisher’s exact test.|Fisher Exact||||
1731609|NCT00541658|3188511|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.919|||||2-Sided|95.0|-1.655|-0.184|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731610|NCT00541658|3188512|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.19|||||2-Sided|95.0|-1.948|-0.432|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731611|NCT00541658|3188512|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.095|||||2-Sided|95.0|-1.861|-0.329|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731612|NCT00541658|3188513|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.579|||||2-Sided|95.0|-1.199|0.042|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731613|NCT00541658|3188513|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.546|||||2-Sided|95.0|-1.17|0.078|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731614|NCT00541658|3188514|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.522|||||2-Sided|95.0|-1.149|0.105|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731615|NCT00541658|3188514|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.557|||||2-Sided|95.0|-1.185|0.071|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731616|NCT00541658|3188515|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265|||||2-Sided|95.0|-0.871|0.342|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731617|NCT00541658|3188515|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.249|||||2-Sided|95.0|-0.86|0.363|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731618|NCT00541658|3188516|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.616|||||2-Sided|95.0|-1.185|-0.046|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731619|NCT00541658|3188516|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.555|||||2-Sided|95.0|-1.128|0.018|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731711|NCT00540124|3188691|Superiority or Other|||||||0.176||||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel||||
1731764|NCT00538785|3188853|Superiority or Other||Risk Ratio (RR)|0.495|||||2-Sided|95.0|0.101|1.989||||||Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF|
1731620|NCT00541658|3188517|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.799|||||2-Sided|95.0|-1.403|-0.194|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731621|NCT00541658|3188517|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.578|||||2-Sided|95.0|-1.189|0.032|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731622|NCT00541658|3188518|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.537|||||2-Sided|95.0|-1.0|-0.074|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731623|NCT00541658|3188518|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.327|||||2-Sided|95.0|-0.793|0.138|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731624|NCT00541658|3188519|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.563|||||2-Sided|95.0|-1.045|-0.08|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731625|NCT00541658|3188519|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.328|||||2-Sided|95.0|-0.811|0.156|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731626|NCT00541658|3188520|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.126|||||2-Sided|95.0|-0.588|0.336|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731627|NCT00541658|3188520|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265|||||2-Sided|95.0|-0.731|0.201|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731628|NCT00541658|3188521|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.468|||||2-Sided|95.0|-0.973|0.037|||||||
1731629|NCT00541658|3188521|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.522|||||2-Sided|95.0|-1.03|-0.014|||||||
1731630|NCT00541658|3188522|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.587|||||2-Sided|95.0|-1.116|-0.059|||||||
1731631|NCT00541658|3188522|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.644|||||2-Sided|95.0|-1.179|-0.11|||||||
1731939|NCT00536471|3189200|Superiority or Other|||||||0.012||||||P-value for Lymphocytes - High.|Fisher Exact||||
1731632|NCT00541658|3188523|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.29|||||2-Sided|95.0|-0.681|0.101|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731633|NCT00541658|3188523|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.288|||||2-Sided|95.0|-0.682|0.106|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731634|NCT00541658|3188524|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.29|||||2-Sided|95.0|-0.692|0.112|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731635|NCT00541658|3188524|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.321|||||2-Sided|95.0|-0.724|0.082|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731636|NCT00541658|3188525|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.072|||||2-Sided|95.0|-0.437|0.294|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731637|NCT00541658|3188525|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.135|||||2-Sided|95.0|-0.504|0.234|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731638|NCT00541658|3188526|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.1||||0.0066|2-Sided|95.0|1.03|1.18|||ANOVA||||
1731639|NCT00541658|3188526|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0547|2-Sided|95.0|1.0|1.16|||ANOVA||||
1731640|NCT00541658|3188527|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.12||||0.0014|2-Sided|95.0|1.04|1.2|||ANOVA||||
1731641|NCT00541658|3188527|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0476|2-Sided|95.0|1.0|1.16|||Fisher Exact||||
1731642|NCT00541658|3188528|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.06||||0.1639|2-Sided|95.0|0.98|1.14|||Fisher Exact||||
1731643|NCT00541658|3188528|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.07||||0.0729|2-Sided|95.0|1.0|1.15|||Fisher Exact||||
1731940|NCT00536471|3189201|Superiority or Other|||||||0.049||||||P-value for Potassium - Low.|Fisher Exact||||
1731644|NCT00541658|3188529|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.07||||0.1207|2-Sided|95.0|0.99|1.15|||Fisher Exact||||
1731645|NCT00541658|3188529|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Relative Risk|1.08||||0.0524|2-Sided|95.0|1.0|1.16|||Fisher Exact||||
1731646|NCT00541658|3188530|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-0.922|||||2-Sided|95.0|-1.62|-0.223|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731647|NCT00541658|3188530|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.059|||||2-Sided|95.0|-1.762|-0.355|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731648|NCT00541658|3188531|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.044|||||2-Sided|95.0|-1.789|-0.299|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731649|NCT00541658|3188531|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|LS Mean Difference|-1.154|||||2-Sided|95.0|-1.903|-0.405|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731650|NCT00541658|3188532|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.322|||||2-Sided|95.0|-0.9|0.256|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731651|NCT00541658|3188532|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.258|||||2-Sided|95.0|-0.836|0.321|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731652|NCT00541658|3188533|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|0.156|||||2-Sided|95.0|-0.382|0.695|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731653|NCT00541658|3188533|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.131|||||2-Sided|95.0|-0.674|0.412|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731654|NCT00541658|3188534|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.265||||0.2955|2-Sided|95.0|-0.763|0.232|||ANOVA|Fixed effects for treatment, pooled center and anticoagulant used.|LS Mean Difference is 5 mg daily minus weekly treatment.||
1731712|NCT00540124|3188692|Superiority or Other|||||||0.415||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731810|NCT00537940|3188989|Superiority or Other|||||||0.6603||||||SGTC seizure: p-value was calculated from the 2-sided Fisher’s exact test.|Fisher Exact||||
1731655|NCT00541658|3188535|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.296|||||2-Sided|95.0|-0.869|0.277|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731656|NCT00541658|3188535|Non-Inferiority or Equivalence|To establish the non-inferiority at one-sided α of 2.5% with 90% power, 651 patients (217 per treatment group) was required to complete at least 52 weeks of the study. Adjusting for 20% dropouts, 272 patients per group were required for randomization. This calculation was based on a non-inferiority margin of 1.5%, a true mean difference (μIR - μDR) of 0.25%, and a common standard deviation of the percent change from baseline in lumbar spine BMD at Week 52 of 4.0%.|Least Squares Mean Difference|-0.233|||||2-Sided|95.0|-0.812|0.345|||||LS Mean Difference is 5 mg daily minus weekly treatment.||
1731657|NCT00541450|3188538|Superiority or Other|||||||0.03|||||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.|||
1731658|NCT00541450|3188540|Superiority or Other||Difference in LS Means|-0.16||||||95.0|-0.37|0.05|||||||
1731659|NCT00541450|3188541|Superiority or Other|||||||0.001|||||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.|||
1731660|NCT00541450|3188542|Superiority or Other|||||||0.002|||||||ANCOVA|For Least Squares Mean, the ANCOVA model included a term for treatment and the baseline value as a covariate.|||
1731661|NCT00541346|3188543|Superiority or Other||Bayesian Mean Change Score|7.6|||>|0.11|2-Sided|95.0|-5.6|20.7||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.|
1731662|NCT00541346|3188544|Superiority or Other||Bayesian Mean Change Score|-5.26|||<|0.01|2-Sided|95.0|-9.37|-1.18||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.|
1731663|NCT00541346|3188545|Superiority or Other||Bayesian Mean Change Score|-3.4|||>|0.06|2-Sided|95.0|-7.9|0.8||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.|
1731664|NCT00541346|3188546|Superiority or Other||Bayesian Mean Change Score|1.94|||>|0.21|2-Sided|95.0|-2.98|6.82||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.|
1731665|NCT00541346|3188547|Superiority or Other||Bayesian Mean Change Score|-10.9|||<|0.001|2-Sided|95.0|-16.8|-5.4||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Above Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds|Random intercept growth curves were fit to all outcome data. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear dose and time effects.|
1731666|NCT00541346|3188548|Superiority or Other||Bayesian random intercept model.|3.5|||<|0.001|2-Sided|95.0|1.8|5.2||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.|
1731681|NCT00540514|3188619|Superiority or Other (legacy)||Response Rate Ratio|1.313||||0.005|2-Sided|95.1|1.082|1.593||Statistical significance defined as P-value < 0.049.|Chi-squared||Response rate ratio = PA/PT. A response rate ratio > 1 favors the albumin-bound paclitaxel/carboplatin arm of the study.|The null hypothesis is that the albumin-bound paclitaxel/carboplatin regimen response rate (PA) is equal to that of the paclitaxel (Taxol)/carboplatin regimen (PT). Superiority of albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin will be established if the lower bound of the 95.1% CI of the response rate ratio is > 1.0.|
1731816|NCT00537940|3188990|Superiority or Other|||||||0.6361||||||Simple Partial: p-value was calculated from the 2-sided Fisher’s exact test.|Fisher Exact||||
1731667|NCT00541346|3188549|Superiority or Other||Bayesian Mean Change Score|4.1|||<|0.01||95.0|1.2|6.9||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.|
1731668|NCT00541346|3188550|Superiority or Other||Bayesian Mean Change Score|7.2|||<|0.001|2-Sided|95.0|3.3|11.1||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.|
1731669|NCT00541346|3188551|Superiority or Other||Bayesian Mean Change Score|10.9|||<|0.001|2-Sided|95.0|5.4|16.8||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.||Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.|
1731670|NCT00541346|3188552|Superiority or Other||Bayesian Mean Change Score|23.1|||<|0.001|2-Sided|95.0|16.9|29.3||Posterior-Predictive Probability of Mean Change Score (Pre-Post) at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.|
1731671|NCT00541346|3188553|Superiority or Other||Bayesian Mean Change Score|26.3|||<|0.001|2-Sided|95.0|19.6|33.1||Posterior-Predictive Probability of Mean Change (Pre-Post) Score at or Below Zero.|Mixed Models Analysis|Bayesian random intercept model.|The confidence interval listed is a Bayesian credible interval which represents the probabilistic likelihood that the population mean change falls within these bounds.|Random intercept growth curves were fit to all outcome data, including intermediate assessments. A Bayesian posterior-predictive mean change score and its associated 95% credible interval were estimated using the MCMC Gibbs sampler with non-informative priors. Models included linear and quadratic dose effects, effect for compliance, baseline Life Participation Scale (LPS) effect, LPS by compliance interaction, a functional time component, and interaction between LPS and time.|
1731672|NCT00541229|3188561|Non-Inferiority or Equivalence|The hypothesis stated that the lower bound of 80% one-sided confidence interval for the comparison in 24-hour WMG reduction between sitagliptin 200 mg and sitagliptin 100 mg is above -5 mg/dL.|Mean Difference (Final Values)|10.1||||||80.0|0.61|9999999.0|||||This is a 1-sided 80% confidence interval and the upper bound 9999999 was used here to indicate positive infinity.|This was pre-defined as a non-superiority test, i.e., to show that sitagliptin 200 mg is not superior to sitagliptin 100 mg. For this comparison, the mean in the sitagliptin 100 mg group was subtracted from the mean in the sitagliptin 200 mg group.|
1731673|NCT00541229|3188561|Superiority or Other||Mean Difference (Final Values)|-41.9|||<|0.001||95.0|-63.6|-20.2|||ANOVA|Model term: treatment||For this comparison, the mean in the placebo group was subtracted from the mean in the sitagliptin 100 mg group.|
1731674|NCT00541229|3188561|Superiority or Other||Mean Difference (Final Values)|-31.8|||<|0.004||95.0|-53.1|-10.5|||ANOVA|Model term: treatment||For this comparison, the mean in the placebo group was subtracted from the mean in the sitagliptin 200 mg group.|
1731675|NCT00540514|3188611|Superiority or Other (legacy)|||||||0.036||||||A nonsignificant interaction P-value (ie, p-value ≥ 0.100) indicates the treatment regimen effect was consistent within a prognostic factor.|Regression, Logistic|Logistic regression model with effects for treatment regimen, prognostic factor (histology), and treatment regimen by prognostic factor interaction.|||
1731676|NCT00540514|3188612|Superiority or Other (legacy)|||||||0.302|||||||Univariate Cox regression|||SPARC correlation with overall survival for the overall SPARC population.|
1731677|NCT00540514|3188615|Superiority or Other (legacy)||Hazard Ratio (HR)|0.901||||0.551|2-Sided|95.0|0.652|1.244||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (Squamous cell carcinoma or Non squamous cell carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) <1 favors the albumin-bound paclitaxel/carboplatin group.||
1731678|NCT00540514|3188616|Superiority or Other (legacy)||Response Rate Ratio|1.074||||0.239|2-Sided|95.0|0.953|1.21|||Chi-squared||||
1731679|NCT00540514|3188617|Superiority or Other (legacy)||Hazard Ratio (HR)|0.922||||0.271|2-Sided|95.1|0.797|1.066||P-value is based on a stratified log rank test stratified by geographic region (North America/Australia, Eastern Europe, or Asia/Pacific) and histology of primary diagnosis (Squamous cell carcinoma, adenocarcinoma, or other carcinoma).|Log Rank||Hazard ratio (albumin-bound paclitaxel/carboplatin to paclitaxel/carboplatin) <1 favors the albumin-bound paclitaxel/carboplatin group.||
1731713|NCT00540124|3188692|Superiority or Other|||||||0.691||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731685|NCT00540449|3188628|Non-Inferiority or Equivalence|If the lower limit of the 95% 2-sided confidence interval of the difference in proportions (TMC278 – EFV) exceeds -12%, non-inferiority of TMC278 versus EFV can be concluded.|Difference in proportion of response|-0.4|||<|0.0001||95.0|-5.9|5.2||Significance level was set at 2.5% (one-sided). No adjustment of p-value for multiple comparisons, since there was only single comparison for the primary endpoint.|Regression, Logistic|Logistic regression model included treatment arm as factor and baseline (log10) viral load as covariate.|Difference in proportion responders was estimated through the logistic regression model.|Assuming a response rate of 75% at 48 weeks for both treatment groups, 340 subjects were needed per treatment (TMC278 or EFV) to establish non-inferiority of TMC278 versus EFV with a maximum allowable difference of 12% and a 1-sided significance level of 2.5%, to yield 95% power.|
1731686|NCT00540436|3188637|Superiority or Other||Mean change|46.82||||||95.0|24.566|69.076|||||||
1731687|NCT00540436|3188638|Superiority or Other||Mean change|33.49||||||95.0|15.231|51.744|||||||
1731688|NCT00540423|3188660|Superiority or Other||Percentage of 75% responders|43.5||||||95.0|23.19|65.51|||||Confidence interval of the percentage of participants for whom at least 75% of their assessments during the course of 26 weeks of SB-494115-GR treatment met the definition of responders.||
1731689|NCT00540423|3188662|Superiority or Other||Risk Difference (RD)|60.0||||||95.0|35.21|84.79|||||The units of risk difference is percentage.||
1731690|NCT00540124|3188685|Superiority or Other|||||||0.494||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731691|NCT00540124|3188685|Superiority or Other|||||||0.709||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731692|NCT00540124|3188686|Superiority or Other|||||||0.257||||||P-value for 12 Week Change Qmean. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731693|NCT00540124|3188686|Superiority or Other|||||||0.696||||||P-value for 12 Week Change Qmean. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731694|NCT00540124|3188686|Superiority or Other|||||||0.831||||||P-value for 12 Week Change Qmax. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731695|NCT00540124|3188686|Superiority or Other|||||||0.838||||||P-value for 12 Week Change Qmax. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731696|NCT00540124|3188687|Superiority or Other|||||||0.439||||||P-value for 12 Week Change Post Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum||||
1731697|NCT00540124|3188687|Superiority or Other|||||||0.704||||||P-value for 12 Week Change Post Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum||||
1731698|NCT00540124|3188687|Superiority or Other|||||||0.595||||||P-value for 12 Week Change Terminal Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum||||
1731699|NCT00540124|3188687|Superiority or Other|||||||0.385||||||P-value for 12 Week Change Terminal Micturation Dribble. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum||||
1731700|NCT00540124|3188688|Superiority or Other|||||||0.985||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum||||
1731701|NCT00540124|3188688|Superiority or Other|||||||0.208||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum||||
1731702|NCT00540124|3188689|Superiority or Other|||||||0.348||||||P-value for 12 Week Change Total Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum||||
1731703|NCT00540124|3188689|Superiority or Other|||||||0.102||||||P-value for 12 Week Change Total Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum||||
1731704|NCT00540124|3188689|Superiority or Other|||||||0.632||||||P-value for 12 Week Change Sleeping Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum||||
1731705|NCT00540124|3188689|Superiority or Other|||||||0.098||||||P-value for 12 Week Change Sleeping Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum||||
1731706|NCT00540124|3188689|Superiority or Other|||||||0.359||||||P-value for 12 Week Change Waking Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum||||
1731707|NCT00540124|3188689|Superiority or Other|||||||0.254||||||P-value for 12 Week Change Waking Voids. Change=Endpoint minus baseline. P-values for pairwise comparison of change difference based on Wilcoxon Rank Sum test.|Wilcoxon Rank Sum||||
1731708|NCT00540124|3188690|Superiority or Other|||||||0.304||||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel||||
1731709|NCT00540124|3188690|Superiority or Other|||||||0.429||||||P-value based on Cochran-Mantel-Haenszel Test with modified ridit scores controlling for alpha block use (yes/no) and lower urinary tract symptom severity as stratification factors.|Cochran-Mantel-Haenszel||||
1731811|NCT00537940|3188989|Superiority or Other|||||||0.6054||||||Complex partial seizure: p-value was calculated from the 2-sided Fisher’s exact test.|Fisher Exact||||
1731714|NCT00540124|3188693|Superiority or Other|||||||0.762||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731715|NCT00540124|3188693|Superiority or Other|||||||0.887||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731716|NCT00540124|3188693|Superiority or Other|||||||0.593||||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731717|NCT00540124|3188693|Superiority or Other|||||||0.892||||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731718|NCT00540124|3188693|Superiority or Other|||||||0.457||||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731719|NCT00540124|3188693|Superiority or Other|||||||0.206||||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731720|NCT00540124|3188694|Superiority or Other|||||||0.243||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731721|NCT00540124|3188694|Superiority or Other|||||||0.169||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731722|NCT00540124|3188694|Superiority or Other|||||||0.464||||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731723|NCT00540124|3188694|Superiority or Other|||||||0.203||||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731724|NCT00540124|3188694|Superiority or Other|||||||0.762||||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731725|NCT00540124|3188694|Superiority or Other|||||||0.306||||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731726|NCT00540124|3188695|Superiority or Other|||||||0.581||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731727|NCT00540124|3188695|Superiority or Other|||||||0.207||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731728|NCT00540124|3188695|Superiority or Other|||||||0.018||||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731729|NCT00540124|3188695|Superiority or Other|||||||0.118||||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731730|NCT00540124|3188695|Superiority or Other|||||||0.009||||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731731|NCT00540124|3188695|Superiority or Other|||||||0.137||||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from ANCOVA with effects for treatment, prior alpha blocker use (yes/no), time (visit), baseline value, and time*treatment interaction. Model used an unstructured covariance.|ANCOVA||||
1731732|NCT00540124|3188696|Superiority or Other|||||||0.112||||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731733|NCT00540124|3188696|Superiority or Other|||||||0.108||||||P-value for 8 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731734|NCT00540124|3188696|Superiority or Other|||||||0.155||||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731735|NCT00540124|3188696|Superiority or Other|||||||0.155||||||P-value for 4 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731812|NCT00537940|3188989|Superiority or Other|||||||0.4721||||||Simple partial seizure: p-value was calculated from the 2-sided Fisher’s exact test.|Fisher Exact||||
1731736|NCT00540124|3188697|Superiority or Other|||||||0.186||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731737|NCT00540124|3188697|Superiority or Other|||||||0.073||||||P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons.|ANCOVA||||
1731738|NCT00539994|3188717|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1731739|NCT00539994|3188717|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1731740|NCT00539942|3188723|Superiority or Other||Mean Difference (Final Values)|10.0|||<|0.05|||||||Chi-squared|||Unable to analyze data|
1731741|NCT00539734|3188730|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparing pre-operative data with postoperative data in terms of changes in amplitude height and implicit time.|
1731742|NCT00539539|3188766|Superiority or Other||Mean Difference (Net)|0.1||||0.73|2-Sided|95.0|-0.5|0.7|||Regression, Linear|||Cluster adjusted difference in average rate.|
1731743|NCT00539539|3188767|Superiority or Other||Mean Difference (Net)|-3.4|||<|0.001|2-Sided|95.0|-5.2|-1.5|||Regression, Linear|||Cluster adjusted difference in the average rate.|
1731744|NCT00539539|3188768|Superiority or Other||Mean Difference (Net)|-4.7|||<|0.001|2-Sided|95.0|-6.4|-3.0|||Regression, Linear|||Cluster adjusted difference in average compression rate.|
1731745|NCT00539539|3188769|Superiority or Other||Mean Difference (Net)|1.6||||0.005|2-Sided|95.0|0.5|2.7|||Regression, Linear|Adjusted for randomization by cluster.||Cluster adjusted difference in means.|
1731746|NCT00539539|3188770|Superiority or Other||Mean Difference (Net)|1.9||||0.016|2-Sided|95.0|0.4|3.4|||Regression, Linear|Difference in means, adjusted for cluster.||Cluster adjusted difference in average CPR fraction.|
1731747|NCT00539539|3188771|Superiority or Other||Risk Difference (RD)|-0.015||||0.21|2-Sided|95.0|-0.039|0.009|||t-test, 2 sided|By-cluster difference in outcome rates.||Average change in cluster-specific risk difference.|
1731748|NCT00539539|3188772|Superiority or Other||Risk Difference (RD)|-0.8||||0.71|2-Sided|95.0|-4.9|3.4|||t-test, 2 sided|||Average difference in cluster-specific rates.|
1731749|NCT00539539|3188773|Superiority or Other||Risk Difference (RD)|0.001||||0.96|2-Sided|95.0|-0.04|0.05|||t-test, 2 sided|||Average change in cluster-specific rates of ROSC.|
1731750|NCT00539240|3188797|Superiority or Other|||||||0.2||||||P<0.05 considered statistically significant. No adjustment for multiple comparisons.|Regression, Linear|adjusted for age, sex, BMI and ethnicity.|||
1731751|NCT00539240|3188797|Superiority or Other|||||||0.04||||||P<0.05 considered statistically significant. No adjustment for multiple comparisons.|Regression, Linear|adjusted for age, sex, BMI and ethnicity|||
1731752|NCT00539240|3188798|Superiority or Other|||||||0.5||||||P<0.05 considered statistically significant, no adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity|||
1731753|NCT00539240|3188798|Superiority or Other|||||||0.04||||||P<0.05 considered statistically significant, No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity.|||
1731754|NCT00539240|3188799|Superiority or Other|||||||0.19||||||P<0.05 considered statistically significant. No adjustment for multiple comparisons (no post-hoc contrasts performed)|ANCOVA|Adjusted for baseline score and personality traits (SCL-90)|||
1731755|NCT00539240|3188800|Superiority or Other|||||||0.5||||||P<0.05 considered statistically significant, No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity|||
1731756|NCT00539240|3188800|Superiority or Other|||||||0.04||||||P<0.05 considered statistically significant. No adjustment for multiple comparisons|Regression, Linear|adjusted for age, sex, BMI and ethnicity|||
1731757|NCT00539006|3188813|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH): stratified approximation to Prescotts test; variation of chi-square test for treatment sequence/subjects no preference.||Statistical analysis applies to FFNS and FPNS categories.|
1731758|NCT00539006|3188814|Superiority or Other||Mean Difference (Net)|-0.6|Standard Error of the Mean|0.22||0.004||95.0|-1.1|-0.2|||ANCOVA||Mean Difference = Mean Change in FPNS - Mean Change in Placebo|FPNS combined across treatment arms 1 & 2 compared with Placebo FPNS combined across treatment arms 1 & 2.|
1731759|NCT00539006|3188814|Superiority or Other||Mean Difference (Net)|-1.1|Standard Error of the Mean|0.22|<|0.001||95.0|-1.5|-0.6|||ANCOVA||Mean Difference = Mean Change in FFNS - Mean Change in Placebo|FFNS combined across treatment arms 1 & 2 compared with Placebo FFNS combined across treatment arms 1 & 2.|
1731760|NCT00538902|3188838|Superiority or Other|||||||0.121|||||||Cochran-Mantel-Haenszel||||
1731761|NCT00538902|3188838|Superiority or Other|||||||0.009||||||The between-treatment comparison between each adalimumab group vs. placebo was performed at the 2-sided alpha = 0.05 significance level, without using a stepwise testing procedure or alpha adjustment.|Cochran-Mantel-Haenszel|Percentage ACR responders at Week 12 were compared between adalimumab and placebo groups, where missing ACR responses were imputed as non-responder.|||
1731762|NCT00538902|3188839|Superiority or Other||Odds Ratio (OR)|2.68||||0.004||95.0|1.35|5.3||Each comparison was tested at the 2-sided alpha level of 0.05. Subjects with missing data were imputed to be non-responders. The overall type I error rate was preserved by a hierarchical stepwise closed testing procedure.|Cochran-Mantel-Haenszel|||A sample size of 42 subjects in the placebo group and 84 subjects in each of the adalimumab groups was needed to achieve 98% power to detect that the ACR20 response rate in the 80 mg adalimumab group was different from placebo and to achieve 84% power to detect that the 40 mg adalimumab group was different from placebo.|
1731763|NCT00538902|3188839|Superiority or Other||Odds Ratio (OR)|2.19||||0.026||95.0|1.09|4.39||Each comparison was tested at the 2-sided alpha level of 0.05. Subjects with missing data were imputed to be non-responders. The overall type I error rate was preserved by a hierarchical stepwise closed testing procedure.|Cochran-Mantel-Haenszel|||A sample size of 42 subjects in the placebo group and 84 subjects in each of the adalimumab groups was needed to achieve 98% power to detect that the ACR20 response rate in the 80 mg adalimumab group was different from placebo and to achieve 84% power to detect that the 40 mg adalimumab group was different from placebo.|
1736197|NCT00486902|3196413|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1731765|NCT00538785|3188854|Superiority or Other||Risk Ratio (RR)|0.746|||||2-Sided|95.0|0.344|1.586||||||Relative risk and confidence interval adjusted for the stratification factor of CHD stratum (cyanotic or other) specified on the CRF|
1731766|NCT00538642|3188886|Superiority or Other||||||<|0.05|||||||ANOVA||||
1731767|NCT00538590|3188930|Superiority or Other|||||||0.91|||||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.|
1731768|NCT00538590|3188931|Superiority or Other|||||||0.4|||||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.|
1731769|NCT00538590|3188932|Superiority or Other|||||||1|||||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.|
1731770|NCT00538590|3188934|Superiority or Other|||||||0.95|||||||ANOVA|||Null hypothesis: post-operative intraocular pressure change in ologen group is equal to that in Mitomycin-C group.|
1731771|NCT00538434|3188953|Superiority or Other||Adjusted mean difference|-1.06|Standard Error of the Mean|7.66||0.8906|2-Sided|95.0|-16.16|14.06||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score|
1731772|NCT00538434|3188953|Superiority or Other||Adjusted mean difference|-5.54|Standard Error of the Mean|7.81||0.4794|2-Sided|95.0|-20.94|9.87||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score|
1731773|NCT00538434|3188953|Superiority or Other||Adjusted mean difference|-1.57|Standard Error of the Mean|7.82||0.8412|2-Sided|95.0|-16.98|13.85||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Global Health Score|
1731774|NCT00538434|3188953|Superiority or Other||Adjusted mean difference|-0.43|Standard Error of the Mean|4.35||0.9217|2-Sided|95.0|-9.0|8.15||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score|
1731775|NCT00538434|3188953|Superiority or Other||Adjusted mean difference|-3.41|Standard Error of the Mean|4.38||0.4375|2-Sided|95.0|-12.05|5.23||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score|
1731776|NCT00538434|3188953|Superiority or Other||Adjusted mean difference|-6.38|Standard Error of the Mean|4.37||0.1459|2-Sided|95.0|-15.01|2.24||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Psychosocial Summary Score|
1731777|NCT00538434|3188953|Superiority or Other||Adjusted mean difference|1.36|Standard Error of the Mean|6.36||0.8306|2-Sided|95.0|-11.19|13.91||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score|
1731778|NCT00538434|3188953|Superiority or Other||Adjusted mean difference|-1.47|Standard Error of the Mean|6.44||0.8196|2-Sided|95.0|-14.17|11.23||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score|
1731779|NCT00538434|3188953|Superiority or Other||Adjusted mean difference|-4.75|Standard Error of the Mean|6.48||0.4644|2-Sided|95.0|-17.53|8.03||Analyzed using analysis of covariance with adjustment for stratification factor and for variable at baseline.|ANCOVA||Comparison of least square means provides the difference (of individual change scores) between each reslizumab dose group and placebo.|Physical Summary Score|
1731780|NCT00538434|3188954|Superiority or Other|||||||0.2955|||||||Cochran-Mantel-Haenszel||||
1731781|NCT00538434|3188954|Superiority or Other|||||||0.0943|||||||Cochran-Mantel-Haenszel||||
1731782|NCT00538434|3188954|Superiority or Other|||||||0.0062|||||||Cochran-Mantel-Haenszel||||
1731783|NCT00538434|3188955|Superiority or Other|||||||0.4905|||||||Cochran-Mantel-Haenszel||||
1731784|NCT00538434|3188955|Superiority or Other|||||||0.5793|||||||Cochran-Mantel-Haenszel||||
1731785|NCT00538434|3188955|Superiority or Other|||||||0.0313|||||||Cochran-Mantel-Haenszel||||
1731786|NCT00538434|3188956|Superiority or Other||Adjusted mean difference|-64.69|Standard Error of the Mean|11.28|<|0.0001|2-Sided|95.0|-86.93|-42.45|||ANCOVA|adjustment for stratification factor and for variable at Baseline|||
1731787|NCT00538434|3188956|Superiority or Other||Adjusted mean difference|-73.03|Standard Error of the Mean|11.29|<|0.0001|2-Sided|95.0|-95.28|-50.78|||ANCOVA|adjustment for stratification factor and for variable at Baseline|||
1731788|NCT00538434|3188956|Superiority or Other||Adjusted mean difference|-52.78|Standard Error of the Mean|11.4|<|0.0001|2-Sided|95.0|-75.24|-30.32|||ANCOVA|adjustment for stratification factor and for variable at Baseline|||
1731789|NCT00537940|3188984|Superiority or Other||Odds Ratio (OR)|0.811||||0.3459|2-Sided|95.0|0.524|1.254|||Regression, Logistic|||Week 21: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.|
1731790|NCT00537940|3188984|Superiority or Other||Odds Ratio (OR)|0.653||||0.0252|2-Sided|95.0|0.449|0.948|||Regression, Logistic|||Baseline: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.|
1731813|NCT00537940|3188989|Superiority or Other|||||||0.5069||||||All partial seizure: p-value was calculated from the 2-sided Fisher’s exact test.|Fisher Exact||||
1731938|NCT00536471|3189200|Superiority or Other|||||||0.038||||||P-value for Hemoglobin - Low.|Fisher Exact||||
1731791|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|0.34|Standard Error of the Mean|1.28||0.7889|2-Sided|95.0|-2.17|2.85|||ANCOVA|||Week 21 Sleep Problem Index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731792|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|3.45|Standard Error of the Mean|1.61||0.0321|2-Sided|95.0|0.3|6.61|||ANCOVA|||Baseline Sleep Problem Index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731793|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|2.06|Standard Error of the Mean|1.66||0.2163|2-Sided|95.0|-1.21|5.32|||ANCOVA|||Week 21 Somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731794|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|2.98|Standard Error of the Mean|1.9||0.1162|2-Sided|95.0|-0.74|6.71|||ANCOVA|||Baseline Somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731795|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|-0.66|Standard Error of the Mean|2.05||0.7491|2-Sided|95.0|-4.69|3.37|||ANCOVA|||Week 21 Adequacy of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731796|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|-2.37|Standard Error of the Mean|2.45||0.3346|2-Sided|95.0|-7.19|2.45|||ANCOVA|||Baseline Adequacy of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731797|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.2||0.9101|2-Sided|95.0|-0.38|0.42|||ANCOVA|||Week 21 Quantity of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731798|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.14||0.8312|2-Sided|95.0|-0.3|0.24|||ANCOVA|||Baseline Quantity of Sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731799|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|-1.93|Standard Error of the Mean|2.11||0.3603|2-Sided|95.0|-6.09|2.22|||ANCOVA|||Week 21 Awaken Short of Breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731800|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|4.03|Standard Error of the Mean|2.52||0.1106|2-Sided|95.0|-0.92|8.98|||ANCOVA|||Baseline Awaken Short of Breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731801|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|1.96|Standard Error of the Mean|2.3||0.3954|2-Sided|95.0|-2.56|6.47|||ANCOVA|||Week 21 snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731802|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|1.19|Standard Error of the Mean|2.82||0.6728|2-Sided|95.0|-4.34|6.73|||ANCOVA|||Baseline snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731803|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|-0.32|Standard Error of the Mean|1.68||0.849|2-Sided|95.0|-3.62|2.98|||ANCOVA|||Week 21 Sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731804|NCT00537940|3188985|Superiority or Other||LS Mean Difference (Final Values)|3.25|Standard Error of the Mean|2.07||0.116|2-Sided|95.0|-0.81|7.31|||ANCOVA|||Baseline Sleep disturbance: ANCOVA model was used to calculate least square (LS) mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country; for post-baseline, baseline was included as a covariate.|
1731805|NCT00537940|3188986|Superiority or Other||LS Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.29||0.5492|2-Sided|95.0|-0.75|0.4|||Ranked ANCOVA|||Change at Week 21/ET, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment1difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731806|NCT00537940|3188986|Superiority or Other||LS Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.35||0.4236|2-Sided|95.0|-0.41|0.97|||Ranked ANCOVA|||Baseline, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731807|NCT00537940|3188986|Superiority or Other||LS Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.32||0.7712|2-Sided|95.0|-0.73|0.54|||ANCOVA|||Change at Week 21 / ET , HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and country as covariates.|
1731808|NCT00537940|3188986|Superiority or Other||LS Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.38||0.5643|2-Sided|95.0|-0.53|0.97|||ANCOVA|||Baseline, HADS-A: ANCOVA model was used to calculate least square (LS) mean estimates of the treatment difference along with 95% CI, with main effects of treatment and and country as covariates.|
1731809|NCT00537940|3188987|Superiority or Other|||||||0.1881||||||p-value is calculated using Fisher Exact Test.|Fisher Exact||||
1740685|NCT00442546|3202441|Superiority or Other|||||||0.673|||||||Cochran-Mantel-Haenszel|||Week 2|
1731817|NCT00537940|3188990|Superiority or Other|||||||0.9232||||||All partial seizure: p-value was calculated from the 2-sided Fisher’s exact test.|Fisher Exact||||
1731818|NCT00537940|3188991|Superiority or Other||Odds Ratio (OR)|0.92||||0.662|2-Sided|95.0|0.635|1.335|||Regression, Logistic|||The odds ratio and its 95% CI are calculated by exponentiating the log odds ratio and 95% CI that correspond to the treatment contrast in the logistic regression model with treatment as fixed effect and Baseline term and country as covariate. All statistical tests for secondary efficacy parameters were two sided and performed at significance level of α = 0.05. The above statistical analysis applies to All Partial Seizures - FAS Population.|
1731819|NCT00537940|3188992|Superiority or Other||Median Difference (Final Values)|0.0||||0.8708|2-Sided|95.0|-6.0|7.0|||Ranked ANCOVA|||Rank analysis of covariance (ANCOVA) model was used to derive p-value with treatment as main effect and cluster as cofactor, percent change in 28-day seizure counts between Baseline and treatment periods as dependent variable. Median differences and 95% confidence interval (CI) were based on Hodges-Lehmann estimation.|
1731820|NCT00537810|3189003|Superiority or Other|||||||0.29|||||||Chi-squared|df=3||12 month follow up|
1731821|NCT00537810|3189003|Superiority or Other|||||||0.13|||||||Chi-squared|df=3||6 month follow up|
1731822|NCT00537810|3189003|Superiority or Other|||||||0.6|||||||Chi-squared|df=3||Post-treatment|
1731823|NCT00537485|3189028|Superiority or Other||Risk Difference (RD)|26.1|||<|0.001|2-Sided|95.0|12.0|40.2|||Chi-squared, Corrected||||
1731824|NCT00537485|3189028|Superiority or Other||Risk Difference (RD)|30.7|||<|0.001|2-Sided|95.0|16.7|44.6|||Chi-squared, Corrected||||
1731825|NCT00537485|3189029|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|1.2||0.002|2-Sided|95.0|-3.7|1.1|||t-test, 2 sided||||
1731826|NCT00537394|3189051|Non-Inferiority or Equivalence|Non-inferiority margin defined as 15 percentage points. If the confidence interval for the difference in regimen failure between omitting versus adding NRTIs was fully below 15 percentage points, then omitting NRTIs would be concluded to be not inferior to adding NRTIs for this outcome.|Risk Difference (RD)|3.2|||||2-Sided|95.0|-6.1|12.5|||||Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and stratum. Differences in week 48 failure proportions by treatment calculated weighted by the inverse of the variance in each stratum.|Null Hypothesis was that omitting NRTIs is inferior to adding NRTIs for the outcome of regimen failure through 48 weeks.|
1731827|NCT00537381|3189055|Superiority or Other||Hazard Ratio (HR)|1.476||||0.163|2-Sided|95.0|0.853|2.522|||Log Rank||Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.||
1731828|NCT00537381|3189056|Superiority or Other|||||||0.018|||||||Fisher Exact||||
1731829|NCT00537381|3189057|Superiority or Other|||||||0.795|||||||Fisher Exact||||
1731830|NCT00537381|3189058|Superiority or Other||Hazard Ratio (HR)|1.728||||0.014|2-Sided|95.0|1.112|2.686|||Log Rank||Hazard ratio and 95% confidence interval was estimated from a Cox proportional hazards model with treatment as the only explanatory factor.||
1731831|NCT00537329|3189059|Superiority or Other||2-sided exact Clopper-Pearson (percent)|71.4||||||95.0|29.0|96.3||||||Receiving chemotherapy = Yes|
1731832|NCT00537329|3189059|Superiority or Other||2-sided exact Clopper-Pearson (percent)|81.0||||||95.0|58.1|94.6||||||Use of Central venous catheter = Yes|
1731833|NCT00537329|3189059|Superiority or Other||2-sided exact Clopper-Pearson (percent)|54.5||||||95.0|23.4|83.3||||||Renal insufficiency (CCC < 30 mL/min)|
1731834|NCT00537329|3189059|Superiority or Other||2-sided exact Clopper-Pearson (percent)|58.8||||||95.0|32.9|81.6||||||Elderly: Age ≥ 65 years|
1731835|NCT00537329|3189059|Superiority or Other||2-sided exact Clopper-Pearson (percent)|87.5||||||95.0|47.3|99.7||||||Previous surgery: Abdominal surgery|
1731836|NCT00537329|3189059|Superiority or Other||2-sided exact Clopper-Pearson (percent)|84.6||||||95.0|54.6|98.1||||||Previous surgery: Any surgery|
1731837|NCT00537329|3189059|Superiority or Other||2-sided exact Clopper-Pearson (percent)|72.2||||||95.0|46.5|90.3||||||Baseline pathogen: Candida tropicalis|
1731838|NCT00537329|3189059|Superiority or Other||2-sided exact Clopper-Pearson (percent)|100.0||||||95.0|2.5|100.0||||||Baseline pathogen: Candida rugosa|
1731839|NCT00537329|3189059|Superiority or Other||2-sided exact Clopper-Pearson (percent)|100.0||||||95.0|39.8|100.0||||||Baseline pathogen: Candida parapsilosis|
1731840|NCT00537329|3189059|Superiority or Other||2-sided exact Clopper-Pearson (percent)|66.7||||||95.0|22.3|95.7||||||Baseline pathogen: Candida glabrata|
1731841|NCT00537329|3189059|Superiority or Other||2-sided exact Clopper-Pearson (percent)|71.4||||||95.0|41.9|91.6||||||Baseline pathogen: Candida albicans|
1731842|NCT00537329|3189059|Superiority or Other||2-sided exact Clopper-Pearson (percent)|75.7||||||95.0|58.8|88.2||||||Neutropenic status: ANC > 500/cmm|
1731843|NCT00537329|3189059|Superiority or Other||2-sided exact Clopper-Pearson (percent)|50.0||||||95.0|1.3|98.7||||||Neutropenic status: ANC ≤ 500/cmm|
1731844|NCT00537329|3189066|Superiority or Other||2-sided exact Clopper-Pearson (percent)|84.2||||||95.0|60.4|96.6||||||12 Wks post baseline: success (erad/presumed erad)|
1731845|NCT00537329|3189066|Superiority or Other||2-sided exact Clopper-Pearson (percent)|94.4||||||95.0|72.7|99.9||||||6 Wks post EOT: success (erad/presumed erad)|
1731846|NCT00537329|3189066|Superiority or Other||2-sided exact Clopper-Pearson (percent)|86.2||||||95.0|68.3|96.1||||||2 Wks post EOT: success (erad/presumed erad)|
1731847|NCT00537329|3189066|Superiority or Other||2-sided exact Clopper-Pearson (percent)|97.1||||||95.0|85.1|99.9||||||EOT: success (erad/presumed erad)|
1731848|NCT00537329|3189066|Superiority or Other||2-sided exact Clopper-Pearson (percent)|97.3||||||95.0|85.8|99.9||||||EOIT: success (erad/presumed erad)|
1731849|NCT00537329|3189067|Superiority or Other||2-sided exact Clopper-Pearson (percent)|85.0||||||95.0|62.1|96.8||||||12 Wks post baseline: success (cure/improvement)|
1731850|NCT00537329|3189067|Superiority or Other||2-sided exact Clopper-Pearson (percent)|94.4||||||95.0|72.7|99.9||||||6 Wks post EOT: success (cure/improvement)|
1731851|NCT00537329|3189067|Superiority or Other||2-sided exact Clopper-Pearson (percent)|92.9||||||95.0|76.5|99.1||||||2 Wks post EOT: success (cure/improvement)|
1731852|NCT00537329|3189067|Superiority or Other||2-sided exact Clopper-Pearson (percent)|94.1||||||95.0|80.3|99.3||||||EOT: success (cure/improvement)|
1731853|NCT00537329|3189067|Superiority or Other||2-sided exact Clopper-Pearson (percent)|97.1||||||95.0|85.1|99.9||||||EOIT: success (cure/improvement)|
1731854|NCT00537329|3189068|Superiority or Other||2-sided exact Clopper-Pearson (percent)|72.7||||||95.0|49.8|89.3||||||12 Wks post baseline|
1731855|NCT00537329|3189068|Superiority or Other||2-sided exact Clopper-Pearson (percent)|89.5||||||95.0|66.9|98.7||||||6 Wks post EOT|
1731856|NCT00537329|3189068|Superiority or Other||2-sided exact Clopper-Pearson (percent)|82.8||||||95.0|64.2|94.2||||||2 Wks post EOT|
1731857|NCT00537329|3189068|Superiority or Other||2-sided exact Clopper-Pearson (percent)|89.2||||||95.0|74.6|97.0||||||EOIT|
1731858|NCT00537329|3189069|Superiority or Other||2-sided exact Clopper-Pearson (percent)|86.1||||||95.0|70.5|95.3||||||Sample size enrollment of 100 subjects was planned. Assuming an overall response rate of 75 percent (%), a 95% confidence interval (CI) for the percentage of subjects responding to treatment would have ranged from 66.3% to 83.7% allowing for 5% nonevaluability. This would have provided a level of precision considered acceptable for this Asian regional study.|
1731859|NCT00537316|3189075|Superiority or Other|||||||0.032|||||||Chi-squared||||
1731860|NCT00537303|3189080|Non-Inferiority or Equivalence|The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the Full Analysis Set and the Per Protocol set.|Mean Difference (Final Values)|0.03||||0.816||95.0|-0.21|0.26||P-value for test of difference between treatments.|ANCOVA|||Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.|
1731861|NCT00537303|3189081|Non-Inferiority or Equivalence|The two treatments are declared equivalent if the 95% Confidence Interval for the estimated difference in means between the two treatment groups is included in the interval from -0.4 to 0.4 for both the full analysis set and the per protocol set|Mean Difference (Final Values)|0.06||||0.606||95.0|-0.17|0.29||P-value for test of difference between treatments.|ANCOVA|Regimen, country and previous oral antidiabetic drug (OAD) use as factors and baseline HbA1c as covariate.||Equivalence analysis with a null hypothesis stating that there is a difference between Advanced and Basic treatment groups of more than 0.4%.|
1731862|NCT00537238|3189090|Superiority or Other||Odds Ratio (OR)|1.432||||0.0696|2-Sided|95.0|0.972|2.11|||Regression, Logistic|||Week 16: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.|
1731863|NCT00537238|3189090|Superiority or Other||Odds Ratio (OR)|1.016||||0.9285|2-Sided|95.0|0.715|1.444|||Regression, Logistic|||Baseline: Logistic regression model was used to estimate odds ratio and corresponding 95% CI of treatment difference, with treatment as fixed effect and for post-baseline assessments baseline was included as a covariate.|
1731864|NCT00537238|3189091|Superiority or Other||LS mean differences|0.64|Standard Error of the Mean|1.34||0.6344|2-Sided|95.0|-2.0|3.27|||ANCOVA|||Week 16 sleep problem index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731865|NCT00537238|3189091|Superiority or Other||LS mean differences|0.13|Standard Error of the Mean|1.64||0.9389|2-Sided|95.0|-3.09|3.34|||ANCOVA|||Baseline sleep problem index (9): ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731866|NCT00537238|3189091|Superiority or Other||LS mean differences|-0.72|Standard Error of the Mean|1.87||0.6984|2-Sided|95.0|-4.4|2.95|||ANCOVA|||Week 16 somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731867|NCT00537238|3189091|Superiority or Other||LS mean differences|1.07|Standard Error of the Mean|2.02||0.5952|2-Sided|95.0|-2.89|5.03|||ANCOVA|||Baseline somnolence: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731868|NCT00537238|3189091|Superiority or Other||LS mean differences|-2.99|Standard Error of the Mean|2.41||0.216|2-Sided|95.0|-7.74|1.75|||ANCOVA|||Week 16 adequacy of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731869|NCT00537238|3189091|Superiority or Other||LS mean differences|-1.44|Standard Error of the Mean|2.53||0.5703|2-Sided|95.0|-6.42|3.54|||ANCOVA|||Baseline adequacy of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731870|NCT00537238|3189091|Superiority or Other||LS mean differences|0.14|Standard Error of the Mean|0.12||0.2615|2-Sided|95.0|-0.1|0.38|||ANCOVA|||Week 16 quantity of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731871|NCT00537238|3189091|Superiority or Other||LS mean differences|-0.04|Standard Error of the Mean|0.14||0.7574|2-Sided|95.0|-0.32|0.24|||ANCOVA|||Baseline quantity of sleep: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731872|NCT00537238|3189091|Superiority or Other||LS mean differences|0.88|Standard Error of the Mean|2.07||0.6708|2-Sided|95.0|-3.18|4.94|||ANCOVA|||Week 16 awaken short of breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731873|NCT00537238|3189091|Superiority or Other||LS mean differences|-1.54|Standard Error of the Mean|2.18||0.4807|2-Sided|95.0|-5.83|2.75|||ANCOVA|||Baseline awaken short of breath: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731874|NCT00537238|3189091|Superiority or Other||LS mean differences|10.02|Standard Error of the Mean|2.42|<|0.0001|2-Sided|95.0|5.27|14.76|||ANCOVA|||Week 16 snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731875|NCT00537238|3189091|Superiority or Other||LS mean differences|-1.7|Standard Error of the Mean|3.18|<|0.593|2-Sided|95.0|-7.94|4.54|||ANCOVA|||Baseline snoring: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731876|NCT00537238|3189091|Superiority or Other||LS mean differences|-1.63|Standard Error of the Mean|1.62|<|0.3154|2-Sided|95.0|-4.83|1.56|||ANCOVA|||Week 16 sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731877|NCT00537238|3189091|Superiority or Other||LS mean differences|-1.03|Standard Error of the Mean|2.06|<|0.6161|2-Sided|95.0|-5.08|3.01|||ANCOVA|||Baseline sleep disturbance: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, for post-baseline assessments baseline was included as a covariate.|
1731878|NCT00537238|3189092|Superiority or Other||LS mean differences|-0.01|Standard Error of the Mean|0.3||0.9749|2-Sided|95.0|-0.61|0.59|||ANCOVA|||Week 16, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731879|NCT00537238|3189092|Superiority or Other||LS mean differences|0.25|Standard Error of the Mean|0.3||0.4008|2-Sided|95.0|-0.34|0.85|||ANCOVA|||Week 16, HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731880|NCT00537238|3189092|Superiority or Other||LS mean differences|0.22|Standard Error of the Mean|0.35||0.5263|2-Sided|95.0|-0.47|0.91|||ANCOVA|||Baseline, HADS-D: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731881|NCT00537238|3189092|Superiority or Other||LS mean differences|-0.09|Standard Error of the Mean|0.37||0.8084|2-Sided|95.0|-0.82|0.64|||ANCOVA|||Baseline, HADS-A: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731882|NCT00537238|3189093|Superiority or Other||LS mean differences|-0.26|Standard Error of the Mean|0.13||0.0495|2-Sided|95.0|-0.52|0.0|||ANCOVA|||Change at Follow-up, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731883|NCT00537238|3189093|Superiority or Other||LS mean differences|-1.35|Standard Error of the Mean|0.61||0.0262|2-Sided|95.0|-2.54|-0.16|||ANCOVA|||Change at Follow-up, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731884|NCT00537238|3189093|Superiority or Other||LS mean differences|-0.14|Standard Error of the Mean|0.11||0.2283|2-Sided|95.0|-0.36|0.09|||ANCOVA|||Change at Week 16, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731885|NCT00537238|3189093|Superiority or Other||LS mean differences|-0.77|Standard Error of the Mean|0.56||0.1697|2-Sided|95.0|-1.88|0.33|||ANCOVA|||Change at Week 16, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731886|NCT00537238|3189093|Superiority or Other||LS mean differences|-0.12|Standard Error of the Mean|0.1||0.2452|2-Sided|95.0|-0.33|0.08|||ANCOVA|||Change at Week 13, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731887|NCT00537238|3189093|Superiority or Other||LS mean differences|-0.31|Standard Error of the Mean|0.55||0.5701|2-Sided|95.0|-1.38|0.76|||ANCOVA|||Change at Week 13, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731888|NCT00537238|3189093|Superiority or Other||LS mean differences|-0.06|Standard Error of the Mean|0.12||0.595|2-Sided|95.0|-0.3|0.17|||ANCOVA|||Change at Week 10, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731889|NCT00537238|3189093|Superiority or Other||LS mean differences|-0.23|Standard Error of the Mean|0.53||0.664|2-Sided|95.0|-1.26|0.81|||ANCOVA|||Change at Week 10, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731890|NCT00537238|3189093|Superiority or Other||LS mean differences|-0.12|Standard Error of the Mean|0.11||0.2457|2-Sided|95.0|-0.34|0.09|||ANCOVA|||Change at Week 7, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731891|NCT00537238|3189093|Superiority or Other||LS mean differences|-0.46|Standard Error of the Mean|0.5||0.3638|2-Sided|95.0|-1.45|0.53|||ANCOVA|||Change at Week 7, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1740686|NCT00442546|3202441|Superiority or Other|||||||0.6118|||||||Cochran-Mantel-Haenszel|||Week 2|
1731892|NCT00537238|3189093|Superiority or Other||LS mean differences|0.17|Standard Error of the Mean|0.18||0.3551|2-Sided|95.0|-0.19|0.52|||ANCOVA|||Baseline, core BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731893|NCT00537238|3189093|Superiority or Other||Least squares (LS) mean difference|1.17|Standard Error of the Mean|0.78||0.1334|2-Sided|95.0|-0.36|2.69|||ANCOVA|||Baseline, total BPRS score: ANCOVA model was used to calculate LS mean estimates of the treatment difference along with 95% CI, with main effects of treatment and combined center, and for post-baseline assessments baseline was included as a covariate.|
1731894|NCT00537238|3189094|Superiority or Other|||||||0.7139|||||||Fisher Exact|||SGTC seizure: p-value was calculated from the 2-sided Fisher’s exact test.|
1731895|NCT00537238|3189094|Superiority or Other|||||||0.0483|||||||Fisher Exact|||Complex partial seizure: p-value was calculated from the 2-sided Fisher’s exact test.|
1731896|NCT00537238|3189094|Superiority or Other|||||||0.9175|||||||Fisher Exact|||Simple partial seizure: p-value was calculated from the 2-sided Fisher’s exact test.|
1731897|NCT00537238|3189094|Superiority or Other|||||||0.0822|||||||Fisher Exact|||All partial seizure: p-value was calculated from the 2-sided Fisher’s exact test.|
1731898|NCT00537238|3189096|Superiority or Other||Median difference|4.1||||0.3571|2-Sided|95.0|-2.6|10.9|||Ranked ANCOVA|||Rank analysis of covariance (ANCOVA) model was used to derive p-value with treatment as main effect and cluster as cofactor, percent change in 28-day seizure counts between baseline and treatment periods as dependent variable. Median differences and 95% confidence interval (CI) were based on Hodges-Lehmann estimation.|
1731899|NCT00537238|3189097|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the difference in proportion (Pregabalin - Levetiracetam) was greater than -0.12.|Difference in Proportion|0.0|||||2-Sided|90.0|-0.08|0.09|||||||
1731900|NCT00536510|3189184|Superiority or Other||Mean Difference (Final Values)|15.9|Standard Error of the Mean|1.68|<|0.001||95.0|12.6|19.2||The significance test was 2-tailed with α=0.05|ANOVA|The efficacy analysis was performed using an ANOVA model with factors for treatment, country, gender, and stratum defined by concomitant statin use.||The secondary hypothesis of superiority of MK0524A 2 g to placebo in lowering High Density Lipoprotein Cholesterol (HDL-C) was assessed using the comparison between these 2 groups from the ANOVA model.|
1731901|NCT00536510|3189185|Superiority or Other||Mean Difference (Final Values)|-14.7|Standard Error of the Mean|1.96|<|0.001||95.0|-18.6|-10.9||The significance test was 2-tailed with α=0.05|ANOVA|The efficacy analysis was performed using an ANOVA model with factors for treatment, country, gender, and stratum defined by concomitant statin use.||The primary hypothesis of superiority of MK0524A 2 g to placebo in lowering Low Density Lipoprotein Cholesterol (LDL-C) was assessed using the comparison between these 2 groups from the ANOVA model.|
1731902|NCT00536484|3189186|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.2|<|0.0001||95.0|-1.3|-0.7||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline|
1731903|NCT00536484|3189186|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.1|<|0.0001||95.0|-1.1|-0.5||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline|
1731904|NCT00536484|3189186|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.9|-0.4||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline|
1731905|NCT00536484|3189187|Superiority or Other|||||||0.0009||||||Significance level p <0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 12|
1731906|NCT00536484|3189187|Superiority or Other|||||||0.01||||||Significance level p <0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 6|
1731907|NCT00536484|3189187|Superiority or Other|||||||0.0129||||||Significance level p <0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 2|
1731908|NCT00536484|3189188|Superiority or Other|||||||0.0006||||||Significance level p <0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 12|
1731909|NCT00536484|3189188|Superiority or Other|||||||0.0008||||||Significance level p <0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 6|
1731910|NCT00536484|3189188|Superiority or Other|||||||0.0087||||||Significance level p <0.05|Cochran-Mantel-Haenszel|The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.||Treatment difference at Week 2|
1731911|NCT00536484|3189189|Superiority or Other||Mean Difference (Final Values)|6.2|Standard Error of the Mean|1.3|<|0.0001||95.0|3.6|8.9||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~HRQL scale score total"|
1731912|NCT00536484|3189189|Superiority or Other||Mean Difference (Final Values)|3.7|Standard Error of the Mean|1.1|<|0.0007||95.0|1.6|5.8||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Social interaction domain"|
1731913|NCT00536484|3189189|Superiority or Other||Mean Difference (Final Values)|4.7|Standard Error of the Mean|1.6|<|0.0036||95.0|1.5|7.8||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline as covariate||"Week 12 minus Baseline~Sleep domain"|
1731914|NCT00536484|3189189|Superiority or Other||Mean Difference (Final Values)|7.1|Standard Error of the Mean|1.6|<|0.0001||95.0|3.9|10.2||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Coping domain"|
1731915|NCT00536484|3189189|Superiority or Other||Mean Difference (Final Values)|8.4|Standard Error of the Mean|1.6|<|0.0001||95.0|5.3|11.5||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|"Week 12 minus Baseline~Concern domain"|
1731916|NCT00536484|3189190|Superiority or Other||Mean Difference (Final Values)|-7.8|Standard Error of the Mean|1.5|<|0.0001||95.0|-10.7|-4.9||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 12 minus Baseline|
1731917|NCT00536484|3189191|Superiority or Other||Mean Difference (Final Values)|-3.3|Standard Error of the Mean|0.8|<|0.0001||95.0|-4.9|-1.7||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline|
1731918|NCT00536484|3189191|Superiority or Other||Mean Difference (Final Values)|-2.7|Standard Error of the Mean|0.8|<|0.0007||95.0|-4.2|-1.1||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline|
1731919|NCT00536484|3189191|Superiority or Other||Mean Difference (Final Values)|-1.7|Standard Error of the Mean|0.7|<|0.0203||95.0|-3.2|-0.3||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline|
1731920|NCT00536484|3189192|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.0806||95.0|-0.4|0.0||Significance level p <0.05|ANOVA|||Week 12 minus Baseline|
1731921|NCT00536484|3189192|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.5059||95.0|-0.2|0.1||Significance level p <0.05|ANOVA|||Week 6 minus Baseline|
1731922|NCT00536484|3189192|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.1||0.8279||95.0|-0.2|0.1||Significance level p <0.05|ANOVA|||Week 2 minus Baseline|
1731923|NCT00536484|3189193|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.324||95.0|-0.2|0.1||Significance level p <0.05|ANOVA|||Week 12 minus Baseline|
1731924|NCT00536484|3189193|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.3881||95.0|-0.2|0.1||Significance level p <0.05|ANOVA|||Week 6 minus Baseline|
1731925|NCT00536484|3189193|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.1||0.8019||95.0|-0.2|0.1||Significance level p <0.05|ANOVA|||Week 2 minus Baseline|
1731926|NCT00536484|3189194|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0167||95.0|-0.6|-0.1||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 12 minus Baseline|
1731927|NCT00536484|3189194|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1||0.0225||95.0|-0.6|0.0||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 6 minus Baseline|
1731928|NCT00536484|3189194|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.2054||95.0|-0.4|0.1||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 2 minus Baseline|
1731929|NCT00536484|3189195|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.2||0.0014||95.0|-1.0|-0.2||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline|
1731930|NCT00536484|3189195|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.2||0.0506||95.0|-0.8|0.0||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline|
1731931|NCT00536484|3189195|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.2||0.1666||95.0|-0.6|0.1||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline|
1731932|NCT00536484|3189196|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.3||0.0003||95.0|-1.5|-0.5||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 12 minus Baseline|
1731933|NCT00536484|3189196|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.3||0.0338||95.0|-1.1|0.0||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 6 minus Baseline|
1731934|NCT00536484|3189196|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.2||0.1057||95.0|-0.9|0.1||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline covariate||Week 2 minus Baseline|
1731935|NCT00536484|3189197|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.2||0.0002||95.0|-1.1|-0.3||Significance level p <0.05|ANCOVA|Terms for center, treatment and baseline as covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 6 minus Baseline|
1731936|NCT00536484|3189197|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.2||0.0136||95.0|-0.8|-0.1||Significance level p <0.05|ANCOVA|Terms for center, treatment, baseline covariate and baseline by treatment interaction|Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline|Week 2 minus Baseline|
1731937|NCT00536484|3189198|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.2||0.0002||95.0|-1.1|-0.4||Significance level p <0.05|ANCOVA|Terms for treatment, center and baseline as covariate and baseline by treatment interaction.|The LS mean difference & 95% CI were calculated at mean baseline = 12.9 (centered baseline used in model)|Null hypothesis: the mean change from baseline in micturitions per 24 hours in the fesoterodine group is the same as in the placebo group at Week 12. A sample size of 350 in each arm had at least 85% power to detect a difference of 0.8 between flexible dose fesoterodine & placebo assuming a standard deviation of 3.52 using a 2-sample t-test with a 0.05 2-sided significance level. Accounting for 10% of randomized subjects not having the primary endpoint data, 390 subjects were needed in each arm|
1740687|NCT00442546|3202441|Superiority or Other|||||||0.0239|||||||Cochran-Mantel-Haenszel|||Discharge|
1731941|NCT00536471|3189201|Superiority or Other|||||||0.012||||||P-value for Lymphocytes - High.|Fisher Exact||||
1731942|NCT00536471|3189202|Superiority or Other|||||||0.048||||||P-value for Potassium - Low.|Fisher Exact||||
1731943|NCT00536471|3189202|Superiority or Other|||||||0.041||||||P-value for Lymphocytes - High.|Fisher Exact||||
1731944|NCT00536471|3189203|Superiority or Other|||||||0.045|||||||ANOVA||||
1731945|NCT00536471|3189204|Superiority or Other|||||||0.033|||||||ANOVA||||
1731946|NCT00536471|3189205|Superiority or Other|||||||0.003||||||P-value for 9 Month Change.|ANOVA||||
1731947|NCT00536471|3189205|Superiority or Other|||||||0.017||||||P-value for 12 Week Change.|ANOVA||||
1731948|NCT00536471|3189206|Superiority or Other|||||||0.043||||||P-value for Sodium - 9 Month Change.|ANOVA||||
1731949|NCT00536471|3189206|Superiority or Other|||||||0.045||||||P-value for Cholesterol - 9 Month Change.|ANOVA||||
1731950|NCT00536471|3189206|Superiority or Other|||||||0.004||||||P-value for Chloride - 9 Month Change.|ANOVA||||
1731951|NCT00536471|3189206|Superiority or Other|||||||0.044||||||P-value for Urea Nitrogen - 12 Week Change.|ANOVA||||
1731952|NCT00536471|3189206|Superiority or Other|||||||0.022||||||P-value for Chloride - 12 Week Change.|ANOVA||||
1731953|NCT00536471|3189207|Superiority or Other|||||||0.014||||||P-value for MCV - 9 Month Change.|ANOVA||||
1731954|NCT00536471|3189207|Superiority or Other|||||||0.013||||||P-value for MCV - 12 Week Change.|ANOVA||||
1731955|NCT00536471|3189208|Superiority or Other|||||||0.029||||||P-value for Hematocrit - 9 Month Change.|ANOVA||||
1731956|NCT00536471|3189208|Superiority or Other|||||||0.037||||||P-value for Hematocrit - 12 Week Change.|ANOVA||||
1731957|NCT00536471|3189209|Superiority or Other|||||||0.013||||||P-value for Uric Acid - 9 Month Change.|ANOVA||||
1731958|NCT00536471|3189209|Superiority or Other|||||||0.033||||||P-value for Bilirubin - 9 Month Change.|ANOVA||||
1731959|NCT00536471|3189209|Superiority or Other|||||||0.003||||||P-value for Uric Acid - 12 Week Change.|ANOVA||||
1731960|NCT00536471|3189209|Superiority or Other|||||||0.031||||||P-value for Creatinine - 12 Week Change.|ANOVA||||
1731961|NCT00536471|3189209|Superiority or Other|||||||0.046||||||P-value for Bilirubin - 12 Week Change.|ANOVA||||
1731962|NCT00536471|3189214|Superiority or Other|||||||0.39||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731963|NCT00536471|3189214|Superiority or Other|||||||0.874||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731964|NCT00536471|3189214|Superiority or Other|||||||0.672||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731965|NCT00536471|3189214|Superiority or Other|||||||0.013||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731966|NCT00536471|3189215|Superiority or Other|||||||0.081||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731967|NCT00536471|3189215|Superiority or Other|||||||0.701||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731968|NCT00536471|3189215|Superiority or Other|||||||0.045||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731969|NCT00536471|3189215|Superiority or Other|||||||0.012||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731970|NCT00536471|3189216|Superiority or Other|||||||0.877||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731971|NCT00536471|3189216|Superiority or Other|||||||0.146||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Diastolic Blood Pressure (DBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731972|NCT00536471|3189216|Superiority or Other|||||||0.614||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731973|NCT00536471|3189216|Superiority or Other|||||||0.874||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Systolic Blood Pressure (SBP) 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731974|NCT00536471|3189216|Superiority or Other|||||||0.034||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731975|NCT00536471|3189216|Superiority or Other|||||||0.296||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Diastolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731976|NCT00536471|3189216|Superiority or Other|||||||0.011||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731977|NCT00536471|3189216|Superiority or Other|||||||0.914||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Systolic Blood Pressure 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732283|NCT00536198|3189285|Superiority or Other|||||||0.69|||||||ANOVA|||Group by time: comparison rates of change|
1731978|NCT00536471|3189217|Superiority or Other|||||||0.04||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731979|NCT00536471|3189217|Superiority or Other|||||||0.231||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731980|NCT00536471|3189217|Superiority or Other|||||||0.006||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731981|NCT00536471|3189217|Superiority or Other|||||||0.001||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731982|NCT00536471|3189218|Superiority or Other|||||||0.407||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731983|NCT00536471|3189218|Superiority or Other|||||||0.982||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731984|NCT00536471|3189218|Superiority or Other|||||||0.198||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731985|NCT00536471|3189218|Superiority or Other|||||||0.161||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731986|NCT00536471|3189219|Superiority or Other|||||||0.388||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731987|NCT00536471|3189219|Superiority or Other|||||||0.705||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731988|NCT00536471|3189219|Superiority or Other||||||<|0.001||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731989|NCT00536471|3189219|Superiority or Other||||||<|0.032||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731990|NCT00536471|3189220|Superiority or Other|||||||0.852||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731991|NCT00536471|3189220|Superiority or Other|||||||0.19||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 7 How Bothered by Pain 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731992|NCT00536471|3189220|Superiority or Other|||||||0.759||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731993|NCT00536471|3189220|Superiority or Other|||||||0.158||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 1 Average Pain Severity 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731994|NCT00536471|3189220|Superiority or Other|||||||0.536||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731995|NCT00536471|3189220|Superiority or Other|||||||0.213||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 7 How Bothered by Pain 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731996|NCT00536471|3189220|Superiority or Other|||||||0.561||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731997|NCT00536471|3189220|Superiority or Other|||||||0.475||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Item 1 Average Pain Severity 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1731998|NCT00536471|3189221|Superiority or Other|||||||0.127||||||P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.|Mixed Models Analysis||||
1731999|NCT00536471|3189221|Superiority or Other|||||||0.665||||||P-value for 12 week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.|Mixed Models Analysis||||
1732000|NCT00536471|3189221|Superiority or Other|||||||0.016||||||P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.|Mixed Models Analysis||||
1732001|NCT00536471|3189221|Superiority or Other|||||||0.653||||||P-value for 12 week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.|Mixed Models Analysis||||
1732002|NCT00536471|3189222|Superiority or Other|||||||0.648||||||P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.|Mixed Models Analysis||||
1732003|NCT00536471|3189222|Superiority or Other|||||||0.218||||||P-value for 9 Month QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.|Mixed Models Analysis||||
1732004|NCT00536471|3189222|Superiority or Other|||||||0.442||||||P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.|Mixed Models Analysis||||
1732005|NCT00536471|3189222|Superiority or Other|||||||0.95||||||P-value for 9 Month HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.|Mixed Models Analysis||||
1732006|NCT00536471|3189222|Superiority or Other|||||||0.022||||||P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.|Mixed Models Analysis||||
1732007|NCT00536471|3189222|Superiority or Other|||||||0.948||||||P-value for 12 Week QIDS16. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.|Mixed Models Analysis||||
1732008|NCT00536471|3189222|Superiority or Other|||||||0.022||||||P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.|Mixed Models Analysis||||
1732009|NCT00536471|3189222|Superiority or Other|||||||0.731||||||P-value for 12 Week HAMD-17. Model=Baseline, Pooled Investigator, Visit, Treatment, and Treatment*Visit.|Mixed Models Analysis||||
1732010|NCT00536471|3189223|Superiority or Other|||||||0.423||||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732011|NCT00536471|3189223|Superiority or Other|||||||0.325||||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732012|NCT00536471|3189223|Superiority or Other|||||||0.029||||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732013|NCT00536471|3189223|Superiority or Other|||||||0.302||||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732014|NCT00536471|3189225|Superiority or Other|||||||0.111||||||P-value for Direct Treatment Effect|Regression, Linear||||
1732015|NCT00536471|3189225|Superiority or Other|||||||0.342||||||P-value for Direct Treatment Effect|Regression, Linear||||
1732016|NCT00536471|3189227|Superiority or Other|||||||0.036||||||P-value for Direct Treatment Effect|Regression, Linear||||
1732017|NCT00536471|3189227|Superiority or Other|||||||0.753||||||P-value for Direct Treatment Effect|Regression, Linear||||
1732018|NCT00536471|3189228|Superiority or Other|||||||0.723||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732019|NCT00536471|3189228|Superiority or Other|||||||0.829||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732020|NCT00536471|3189228|Superiority or Other|||||||0.755||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732021|NCT00536471|3189228|Superiority or Other|||||||0.519||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732022|NCT00536471|3189228|Superiority or Other|||||||0.761||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732023|NCT00536471|3189228|Superiority or Other|||||||0.789||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732024|NCT00536471|3189228|Superiority or Other|||||||0.895||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732025|NCT00536471|3189228|Superiority or Other|||||||0.921||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732026|NCT00536471|3189229|Superiority or Other|||||||0.005||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732027|NCT00536471|3189229|Superiority or Other|||||||0.142||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score(Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732028|NCT00536471|3189229|Superiority or Other|||||||0.002||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732029|NCT00536471|3189229|Superiority or Other|||||||0.092||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Family Life (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732030|NCT00536471|3189229|Superiority or Other|||||||0.044||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732031|NCT00536471|3189229|Superiority or Other|||||||0.229||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Social Life (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732032|NCT00536471|3189229|Superiority or Other|||||||0.065||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732033|NCT00536471|3189229|Superiority or Other|||||||0.366||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Work Life (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732034|NCT00536471|3189230|Superiority or Other|||||||0.505||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Confusion-Bewilderment(Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732035|NCT00536471|3189230|Superiority or Other|||||||0.11||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732036|NCT00536471|3189230|Superiority or Other|||||||0.602||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732037|NCT00536471|3189230|Superiority or Other|||||||0.986||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732038|NCT00536471|3189230|Superiority or Other|||||||0.522||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732039|NCT00536471|3189230|Superiority or Other|||||||0.765||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732040|NCT00536471|3189230|Superiority or Other|||||||0.234||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732041|NCT00536471|3189230|Superiority or Other|||||||0.426||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732042|NCT00536471|3189230|Superiority or Other|||||||0.257||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732043|NCT00536471|3189230|Superiority or Other|||||||0.366||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732044|NCT00536471|3189230|Superiority or Other|||||||0.265||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732045|NCT00536471|3189230|Superiority or Other|||||||0.251||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732046|NCT00536471|3189230|Superiority or Other|||||||0.584||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732047|NCT00536471|3189230|Superiority or Other|||||||0.639||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732048|NCT00536471|3189231|Superiority or Other|||||||0.313||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732049|NCT00536471|3189231|Superiority or Other|||||||0.09||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Confusion-Bewilderment (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732050|NCT00536471|3189231|Superiority or Other|||||||0.435||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732051|NCT00536471|3189231|Superiority or Other|||||||0.368||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Fatigue-Inertia (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732052|NCT00536471|3189231|Superiority or Other|||||||0.069||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732053|NCT00536471|3189231|Superiority or Other|||||||0.201||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Vigor-Activity (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732054|NCT00536471|3189231|Superiority or Other|||||||0.019||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732055|NCT00536471|3189231|Superiority or Other|||||||0.01||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Anger-Hostility (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732056|NCT00536471|3189231|Superiority or Other|||||||0.005||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732057|NCT00536471|3189231|Superiority or Other|||||||0.01||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Depression-Dejection (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732058|NCT00536471|3189231|Superiority or Other|||||||0.324||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732059|NCT00536471|3189231|Superiority or Other|||||||0.02||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Tension-Anxiety (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732060|NCT00536471|3189231|Superiority or Other|||||||0.031||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732061|NCT00536471|3189231|Superiority or Other|||||||0.007||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for Total Score (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732062|NCT00536471|3189232|Superiority or Other|||||||0.676||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732063|NCT00536471|3189232|Superiority or Other|||||||0.576||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732064|NCT00536471|3189232|Superiority or Other|||||||0.139||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732065|NCT00536471|3189232|Superiority or Other|||||||0.675||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732066|NCT00536471|3189233|Superiority or Other|||||||0.676||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732067|NCT00536471|3189233|Superiority or Other|||||||0.576||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732068|NCT00536471|3189233|Superiority or Other|||||||0.002||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732069|NCT00536471|3189233|Superiority or Other|||||||0.175||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732070|NCT00536471|3189234|Superiority or Other|||||||1||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732071|NCT00536471|3189234|Superiority or Other|||||||0.175||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732072|NCT00536471|3189234|Superiority or Other|||||||0.135||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732073|NCT00536471|3189234|Superiority or Other|||||||0.505||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732074|NCT00536471|3189235|Superiority or Other|||||||0.668||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732075|NCT00536471|3189235|Superiority or Other|||||||0.692||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732076|NCT00536471|3189235|Superiority or Other|||||||0.678||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732077|NCT00536471|3189235|Superiority or Other|||||||0.487||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732078|NCT00536471|3189236|Superiority or Other|||||||0.668||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732079|NCT00536471|3189236|Superiority or Other|||||||0.692||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732080|NCT00536471|3189236|Superiority or Other|||||||0.466||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732081|NCT00536471|3189236|Superiority or Other|||||||0.507||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732082|NCT00536471|3189237|Superiority or Other|||||||0.668||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732083|NCT00536471|3189237|Superiority or Other|||||||0.692||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732084|NCT00536471|3189237|Superiority or Other|||||||0.758||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732085|NCT00536471|3189237|Superiority or Other|||||||0.588||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732086|NCT00536471|3189238|Superiority or Other|||||||0.668||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732087|NCT00536471|3189238|Superiority or Other|||||||0.692||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732088|NCT00536471|3189238|Superiority or Other|||||||0.018||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732089|NCT00536471|3189238|Superiority or Other|||||||0.438||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732090|NCT00536471|3189239|Superiority or Other|||||||0.813||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732091|NCT00536471|3189239|Superiority or Other|||||||0.2||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732092|NCT00536471|3189239|Superiority or Other|||||||0.001||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732093|NCT00536471|3189239|Superiority or Other|||||||0.682||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732094|NCT00536471|3189240|Superiority or Other|||||||0.268||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732095|NCT00536471|3189240|Superiority or Other|||||||1||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732096|NCT00536471|3189240|Superiority or Other|||||||0.949||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732097|NCT00536471|3189240|Superiority or Other|||||||0.723||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732098|NCT00536471|3189241|Superiority or Other|||||||0.268||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732099|NCT00536471|3189241|Superiority or Other|||||||1||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732100|NCT00536471|3189241|Superiority or Other|||||||0.722||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732101|NCT00536471|3189241|Superiority or Other|||||||0.741||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732102|NCT00536471|3189242|Superiority or Other|||||||0.268||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732103|NCT00536471|3189242|Superiority or Other|||||||1||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732104|NCT00536471|3189242|Superiority or Other|||||||0.256||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732105|NCT00536471|3189242|Superiority or Other|||||||0.517||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732106|NCT00536471|3189243|Superiority or Other|||||||0.024||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732107|NCT00536471|3189243|Superiority or Other|||||||0.637||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732108|NCT00536471|3189243|Superiority or Other|||||||0.152||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732109|NCT00536471|3189243|Superiority or Other|||||||0.78||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732110|NCT00536471|3189244|Superiority or Other|||||||0.717||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732111|NCT00536471|3189244|Superiority or Other|||||||0.414||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732112|NCT00536471|3189244|Superiority or Other|||||||0.012||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732113|NCT00536471|3189244|Superiority or Other|||||||0.789||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732114|NCT00536471|3189245|Superiority or Other|||||||0.908||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732115|NCT00536471|3189245|Superiority or Other|||||||0.853||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732116|NCT00536471|3189245|Superiority or Other|||||||0.216||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732117|NCT00536471|3189245|Superiority or Other|||||||0.234||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732118|NCT00536471|3189246|Superiority or Other|||||||0.913||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732119|NCT00536471|3189246|Superiority or Other|||||||0.853||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732120|NCT00536471|3189246|Superiority or Other|||||||0.312||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732121|NCT00536471|3189246|Superiority or Other|||||||0.723||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732122|NCT00536471|3189247|Superiority or Other|||||||0.253||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732123|NCT00536471|3189247|Superiority or Other|||||||0.665||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732124|NCT00536471|3189247|Superiority or Other|||||||0.002||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732125|NCT00536471|3189247|Superiority or Other|||||||0.038||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732126|NCT00536471|3189248|Superiority or Other|||||||0.381||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732127|NCT00536471|3189248|Superiority or Other|||||||0.571||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732128|NCT00536471|3189248|Superiority or Other|||||||0.796||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732129|NCT00536471|3189248|Superiority or Other|||||||0.896||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732130|NCT00536471|3189249|Superiority or Other|||||||0.567||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732131|NCT00536471|3189249|Superiority or Other|||||||0.93||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732132|NCT00536471|3189249|Superiority or Other|||||||0.059||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732133|NCT00536471|3189249|Superiority or Other|||||||0.67||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732134|NCT00536471|3189250|Superiority or Other|||||||0.567||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732135|NCT00536471|3189250|Superiority or Other|||||||0.577||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732136|NCT00536471|3189251|Superiority or Other|||||||0.233||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732137|NCT00536471|3189251|Superiority or Other|||||||0.473||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732138|NCT00536471|3189251|Superiority or Other|||||||0.223||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732139|NCT00536471|3189251|Superiority or Other|||||||0.099||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732140|NCT00536471|3189252|Superiority or Other|||||||0.086||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732141|NCT00536471|3189252|Superiority or Other|||||||0.787||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732142|NCT00536471|3189252|Superiority or Other|||||||0.473||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732143|NCT00536471|3189252|Superiority or Other|||||||0.624||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732144|NCT00536471|3189253|Superiority or Other|||||||0.588||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732145|NCT00536471|3189253|Superiority or Other|||||||0.775||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732146|NCT00536471|3189253|Superiority or Other|||||||0.041||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732147|NCT00536471|3189253|Superiority or Other|||||||0.332||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732148|NCT00536471|3189254|Superiority or Other|||||||0.133||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732149|NCT00536471|3189254|Superiority or Other|||||||0.571||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732150|NCT00536471|3189254|Superiority or Other|||||||0.1||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732151|NCT00536471|3189254|Superiority or Other|||||||0.023||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732152|NCT00536471|3189255|Superiority or Other|||||||0.133||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732153|NCT00536471|3189255|Superiority or Other|||||||0.571||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732154|NCT00536471|3189255|Superiority or Other|||||||0.011||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732155|NCT00536471|3189255|Superiority or Other|||||||0.204||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change(Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732156|NCT00536471|3189256|Superiority or Other|||||||0.417||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732157|NCT00536471|3189256|Superiority or Other|||||||0.653||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732158|NCT00536471|3189256|Superiority or Other||||||<|0.001||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732159|NCT00536471|3189256|Superiority or Other||||||<|0.016||||||Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732160|NCT00536471|3189257|Superiority or Other|||||||0.167||||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732161|NCT00536471|3189257|Superiority or Other|||||||0.449||||||P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732162|NCT00536471|3189257|Superiority or Other||||||<|0.001||||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline)|Mixed Models Analysis||||
1732163|NCT00536471|3189257|Superiority or Other||||||<|0.011||||||P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).|Mixed Models Analysis||||
1732164|NCT00536471|3189258|Superiority or Other|||||||0.275||||||P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732165|NCT00536471|3189258|Superiority or Other|||||||0.646||||||P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732166|NCT00536471|3189258|Superiority or Other|||||||0.216||||||P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732167|NCT00536471|3189258|Superiority or Other|||||||0.568||||||P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732168|NCT00536471|3189258|Superiority or Other|||||||0.334||||||P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732169|NCT00536471|3189258|Superiority or Other|||||||0.66||||||P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732170|NCT00536471|3189258|Superiority or Other|||||||0.368||||||P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732284|NCT00536198|3189285|Superiority or Other||||||<|0.0001|||||||ANOVA|||Change over time in both groups|
1732171|NCT00536471|3189258|Superiority or Other|||||||0.736||||||P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732172|NCT00536471|3189258|Superiority or Other|||||||0.595||||||P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732173|NCT00536471|3189258|Superiority or Other|||||||0.525||||||P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732174|NCT00536471|3189258|Superiority or Other|||||||0.194||||||P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732175|NCT00536471|3189258|Superiority or Other|||||||0.629||||||P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732176|NCT00536471|3189258|Superiority or Other|||||||0.062||||||P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732177|NCT00536471|3189258|Superiority or Other|||||||0.149||||||P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732178|NCT00536471|3189258|Superiority or Other||||||<|0.001||||||P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732179|NCT00536471|3189258|Superiority or Other||||||<|0.076||||||P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732180|NCT00536471|3189258|Superiority or Other||||||<|0.001||||||P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732181|NCT00536471|3189258|Superiority or Other||||||<|0.027||||||P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732182|NCT00536471|3189258|Superiority or Other||||||<|0.001||||||P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732183|NCT00536471|3189258|Superiority or Other||||||<|0.202||||||P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732184|NCT00536471|3189258|Superiority or Other||||||<|0.001||||||P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732185|NCT00536471|3189258|Superiority or Other||||||<|0.026||||||P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732186|NCT00536471|3189258|Superiority or Other||||||<|0.001||||||P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732187|NCT00536471|3189258|Superiority or Other||||||<|0.013||||||P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|Mixed Models Analysis||||
1732188|NCT00536471|3189259|Superiority or Other||||||<|0.001||||||Repeated Measures Analysis for Group B change from baseline to 8 week endpoint.|Mixed Models Analysis|Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|||
1732189|NCT00536471|3189259|Superiority or Other||||||<|0.051||||||Repeated Measures Analysis for Group A change from baseline to 8 week endpoint.|Mixed Models Analysis|Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit|||
1732190|NCT00536380|3189260|Superiority or Other|||||||0.721|||||||ANCOVA||||
1732191|NCT00536263|3189265|Superiority or Other||Pairwise rate difference|0.0|||||2-Sided|95.0|-1.1|1.1|||||||
1732192|NCT00536263|3189265|Superiority or Other||Pairwise rate difference|-0.3||||0.617|2-Sided|95.0|-1.4|0.8|||ANCOVA|Treatment group and genotype were the fixed effects and baseline was the covariate.|||
1732193|NCT00536263|3189265|Superiority or Other||Pairwise rate difference|-0.2||||0.631|2-Sided|95.0|-1.2|0.8|||ANCOVA|Treatment group and genotype were the fixed effects and baseline was the covariate.|||
1732194|NCT00536263|3189265|Superiority or Other|||||||0.01|||||||t-test, 2 sided|comparison of post-treatment versus baseline values|||
1732195|NCT00536263|3189265|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|comparison of post-treatment versus baseline values|||
1732196|NCT00536263|3189265|Superiority or Other||||||<|0.014|||||||t-test, 2 sided|comparison of post-treatment versus baseline values|||
1732197|NCT00536263|3189266|Superiority or Other||Pairwise rate difference|-0.009|||||2-Sided|90.0|-0.019|0.001||||||24 weeks after EOT|
1732198|NCT00536263|3189266|Superiority or Other||Pairwise rate difference|0.009||||0.157|2-Sided|95.0|-0.003|0.021|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732199|NCT00536263|3189266|Superiority or Other|||||||0.991|||||||Cochran-Mantel-Haenszel|"Stratified by genotype~Due to zero responses in the 2 arms, pairwise rate difference & corresponding 95% confidence interval were not applicable."||24 weeks after EOT|
1732200|NCT00536263|3189266|Superiority or Other||Pairwise rate difference|-0.004|||||2-Sided|90.0|-0.012|0.003||||||End of treatment|
1732201|NCT00536263|3189266|Superiority or Other||Pairwise rate difference|0.004||||0.322|2-Sided|95.0|-0.004|0.013|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732202|NCT00536263|3189266|Superiority or Other|||||||0.991|||||||Cochran-Mantel-Haenszel|"Stratified by genotype~Due to zero responses in the 2 arms, pairwise rate difference & corresponding 95% confidence interval were not applicable."||End of treatment|
1732203|NCT00536263|3189267|Superiority or Other||Pairwise rate difference|-0.013|||||2-Sided|90.0|-0.03|0.003||||||24 weeks after EOT|
1732204|NCT00536263|3189267|Superiority or Other||Pairwise rate difference|0.013||||0.179|2-Sided|95.0|-0.006|0.033|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732205|NCT00536263|3189267|Superiority or Other||Pairwise rate difference|0.0||||0.971|2-Sided|95.0|-0.012|0.012|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732206|NCT00536263|3189267|Superiority or Other||Pairwise rate difference|-0.013|||||2-Sided|90.0|-0.03|0.003||||||End of treatment|
1732207|NCT00536263|3189267|Superiority or Other||Pairwise rate difference|0.013||||0.181|2-Sided|95.0|-0.006|0.033|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732208|NCT00536263|3189267|Superiority or Other||Pairwise rate difference|0.0||||0.991|2-Sided|95.0|-0.012|0.012|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732209|NCT00536263|3189268|Superiority or Other||Pairwise rate difference|-0.097|||||2-Sided|90.0|-0.152|-0.041||||||24 weeks after EOT|
1732210|NCT00536263|3189268|Superiority or Other||Pairwise rate difference|0.121|||<|0.001|2-Sided|95.0|0.058|0.184|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732211|NCT00536263|3189268|Superiority or Other||Pairwise rate difference|0.024|||<|0.389|2-Sided|95.0|-0.03|0.078|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732212|NCT00536263|3189268|Superiority or Other||Pairwise rate difference|-0.053|||<||2-Sided|90.0|-0.094|-0.012||||||End of treatment|
1732213|NCT00536263|3189268|Superiority or Other||Pairwise rate difference|0.054|||<|0.031|2-Sided|95.0|0.005|0.103|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732214|NCT00536263|3189268|Superiority or Other||Pairwise rate difference|0.001|||<|0.995|2-Sided|95.0|-0.039|0.041|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732215|NCT00536263|3189269|Superiority or Other||Pairwise rate difference|-0.098|||||2-Sided|90.0|-0.174|-0.021||||||24 weeks after EOT|
1732216|NCT00536263|3189269|Superiority or Other||Pairwise rate difference|0.18|||<|0.001|2-Sided|95.0|0.092|0.268|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732217|NCT00536263|3189269|Superiority or Other||Pairwise rate difference|0.082|||<|0.067|2-Sided|95.0|-0.004|0.168|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732218|NCT00536263|3189269|Superiority or Other||Pairwise rate difference|-0.071|||<||2-Sided|90.0|-0.148|0.006||||||End of treatment|
1732219|NCT00536263|3189269|Superiority or Other||Pairwise rate difference|0.126|||<|0.006|2-Sided|95.0|0.037|0.216|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732220|NCT00536263|3189269|Superiority or Other||Pairwise rate difference|0.056|||<|0.219|2-Sided|95.0|-0.033|0.145|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732221|NCT00536263|3189270|Superiority or Other||Pairwise rate difference|-0.022|||||2-Sided|90.0|-0.046|0.002||||||24 weeks after EOT|
1732222|NCT00536263|3189270|Superiority or Other||Pairwise rate difference|0.018||||0.232|2-Sided|95.0|-0.012|0.048|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732223|NCT00536263|3189270|Superiority or Other||Pairwise rate difference|-0.004||||0.724|2-Sided|95.0|-0.027|0.019|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732224|NCT00536263|3189270|Superiority or Other||Pairwise rate difference|-0.022|||||2-Sided|90.0|-0.046|0.002||||||End of treatment|
1732225|NCT00536263|3189270|Superiority or Other||Pairwise rate difference|0.018||||0.243|2-Sided|95.0|-0.012|0.048|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732226|NCT00536263|3189270|Superiority or Other||Pairwise rate difference|-0.004||||0.724|2-Sided|95.0|-0.027|0.019|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732227|NCT00536263|3189271|Superiority or Other||Pairwise rate difference|-0.044|||||2-Sided|90.0|-0.085|-0.003||||||24 weeks after EOT|
1732228|NCT00536263|3189271|Superiority or Other||Pairwise rate difference|0.045||||0.074|2-Sided|95.0|-0.004|0.094|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732229|NCT00536263|3189271|Superiority or Other||Pairwise rate difference|0.001||||0.969|2-Sided|95.0|-0.041|0.043|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732230|NCT00536263|3189271|Superiority or Other||Pairwise rate difference|-0.03|||||2-Sided|90.0|-0.072|0.011||||||End of treatment|
1732231|NCT00536263|3189271|Superiority or Other||Pairwise rate difference|0.049||||0.04|2-Sided|95.0|0.003|0.096|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732232|NCT00536263|3189271|Superiority or Other||Pairwise rate difference|0.019||||0.373|2-Sided|95.0|-0.023|0.061|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732233|NCT00536263|3189272|Superiority or Other||Pairwise rate difference|-0.122|||||2-Sided|90.0|-0.191|-0.053||||||24 weeks after EOT|
1732234|NCT00536263|3189272|Superiority or Other||Pairwise rate difference|0.139|||<|0.001|2-Sided|95.0|0.059|0.22|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732235|NCT00536263|3189272|Superiority or Other||Pairwise rate difference|0.017|||<|0.662|2-Sided|95.0|-0.058|0.092|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732236|NCT00536263|3189272|Superiority or Other||Pairwise rate difference|-0.063|||<||2-Sided|90.0|-0.135|0.009||||||End of treatment|
1732237|NCT00536263|3189272|Superiority or Other||Pairwise rate difference|0.135|||<|0.001|2-Sided|95.0|0.053|0.216|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732238|NCT00536263|3189272|Superiority or Other||Pairwise rate difference|0.072|||<|0.076|2-Sided|95.0|-0.007|0.151|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732239|NCT00536263|3189273|Superiority or Other||Pairwise rate difference|-0.136||||||90.0|-0.201|-0.071||||||24 weeks after EOT|
1732240|NCT00536263|3189273|Superiority or Other||Pairwise rate difference|0.13||||0.001|2-Sided|95.0|0.053|0.208|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732241|NCT00536263|3189273|Superiority or Other||Pairwise rate difference|-0.006||||0.83|2-Sided|95.0|-0.075|0.063|||Cochran-Mantel-Haenszel|Stratified by genotype||24 weeks after EOT|
1732242|NCT00536263|3189273|Superiority or Other||Pairwise rate difference|-0.056|||||2-Sided|90.0|-0.112|-0.001||||||End of treatment|
1732243|NCT00536263|3189273|Superiority or Other||Pairwise rate difference|0.041||||0.24|2-Sided|95.0|-0.027|0.108|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732285|NCT00536198|3189285|Superiority or Other||||||<|0.46|||||||ANOVA|||Group comparison|
1732244|NCT00536263|3189273|Superiority or Other||Pairwise rate difference|-0.016||||0.598|2-Sided|95.0|-0.078|0.047|||Cochran-Mantel-Haenszel|Stratified by genotype||End of treatment|
1732245|NCT00536263|3189274|Superiority or Other||Pairwise rate difference|-0.065|||||2-Sided|90.0|-0.122|-0.008|||||||
1732246|NCT00536263|3189274|Superiority or Other||Pairwise rate difference|0.054||||0.125|2-Sided|95.0|-0.014|0.123|||Cochran-Mantel-Haenszel|Stratified by genotype|||
1732247|NCT00536263|3189274|Superiority or Other||Pairwise rate difference|-0.011||||0.7|2-Sided|95.0|-0.074|0.052|||Cochran-Mantel-Haenszel|Stratified by genotype|||
1732248|NCT00536263|3189275|Non-Inferiority or Equivalence|The noninferiority of PEG 1.5 mcg/kg*24 weeks with respect to PEG 1.5 mcg/kg*48 weeks was to be concluded if the lower bound of the one-sided 95% confidence interval of the difference of the rates (PEG 1.5 mcg/kg*24 weeks minus PEG 1.5 mcg/kg*48 weeks) was greater than the noninferiority margin of -10%.|Pairwise rate difference|-0.132|||||2-Sided|90.0|-0.198|-0.065|||||||
1732249|NCT00536263|3189275|Superiority or Other||Pairwise rate difference|0.139|||<|0.001|2-Sided|95.0|0.061|0.217||P-values are unadjusted; Hochberg’s adjustment for multiple comparisons was used to maintain the overall 0.05 significance level in test of superiority using the Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by genotype||"Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm."|
1732250|NCT00536263|3189275|Superiority or Other||Pairwise rate difference|0.008|||<|0.86|2-Sided|95.0|-0.063|0.079||P-values are unadjusted; Hochberg’s adjustment for multiple comparisons was used to maintain the overall 0.05 significance level in test of superiority using the Cochran-Mantel-Haenszel test.|Cochran-Mantel-Haenszel|Stratified by genotype||"Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm."|
1732251|NCT00536198|3189276|Superiority or Other||Mean Difference (Final Values)|0.55||||0.056|2-Sided|95.0|0.3|1.02|||Mixed Models Analysis|||Estimated mean difference between active and placebo groups at end-point only|
1732252|NCT00536198|3189276|Superiority or Other||||||<|0.001|||||||Chi-squared|||Group by time: comparison rates of change|
1732253|NCT00536198|3189276|Superiority or Other||||||<|0.01|||||||Chi-squared|||Group comparison|
1732254|NCT00536198|3189277|Superiority or Other||Median Difference (Net)|1.22||||0.027|2-Sided|95.0|1.05|1.41|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo|
1732255|NCT00536198|3189277|Superiority or Other||||||<|0.01|||||||ANOVA|||Group by time: comparison rates of change|
1732256|NCT00536198|3189277|Superiority or Other||||||<|0.001|||||||ANOVA|||Change over time in both groups|
1732257|NCT00536198|3189277|Superiority or Other||||||<|0.001|||||||ANOVA|||Group comparison|
1732258|NCT00536198|3189278|Superiority or Other||Mean Difference (Net)|1.09||||0.94|2-Sided|95.0|0.96|1.23|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo|
1732259|NCT00536198|3189278|Superiority or Other|||||||0.46|||||||ANOVA|||Group by time: comparison rates of change|
1732260|NCT00536198|3189278|Superiority or Other||||||<|0.001|||||||ANOVA|||Change over time in both groups|
1732261|NCT00536198|3189278|Superiority or Other||||||<|0.31|||||||ANOVA|||Group comparison|
1732262|NCT00536198|3189279|Superiority or Other||Mean Difference (Net)|1.08||||0.13|2-Sided|95.0|0.91|1.28|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo|
1732263|NCT00536198|3189279|Superiority or Other|||||||0.73|||||||ANOVA|||Group by time: comparison rates of change|
1732264|NCT00536198|3189279|Superiority or Other||||||<|0.001|||||||ANOVA|||Change over time in both groups|
1732265|NCT00536198|3189279|Superiority or Other||||||<|0.37|||||||ANOVA|||Group comparison|
1732266|NCT00536198|3189280|Superiority or Other||Mean Difference (Net)|1.09||||0.169|2-Sided|95.0|0.96|1.25|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo|
1732267|NCT00536198|3189280|Superiority or Other|||||||0.02|||||||ANOVA|||Group by time: comparison rates of change|
1732268|NCT00536198|3189280|Superiority or Other||||||<|0.001|||||||ANOVA|||Change over time in both groups|
1732269|NCT00536198|3189280|Superiority or Other||||||<|0.83|||||||ANOVA|||Group comparison|
1732270|NCT00536198|3189281|Superiority or Other||Mean Difference (Net)|1.11||||0.61|2-Sided|95.0|0.85|1.45|||Mixed Models Analysis|||Estimated mean difference from baseline to endpoint between active vs. placebo|
1732271|NCT00536198|3189281|Superiority or Other|||||||0.43|||||||ANOVA|||Group by time: comparison rates of change|
1732272|NCT00536198|3189281|Superiority or Other||||||<|0.001|||||||ANOVA|||Change over time in both groups|
1732273|NCT00536198|3189281|Superiority or Other||||||<|0.8|||||||ANOVA|||Group comparison|
1732274|NCT00536198|3189282|Superiority or Other||Mean Difference (Net)|1.12||||0.06|2-Sided|95.0|0.92|1.35|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo|
1732275|NCT00536198|3189282|Superiority or Other|||||||0.73|||||||ANOVA|||Group by time: comparison rates of change|
1732276|NCT00536198|3189282|Superiority or Other||||||<|0.01|||||||ANOVA|||Change over time in both groups|
1732277|NCT00536198|3189282|Superiority or Other||||||<|0.3|||||||ANOVA|||Group comparison|
1732278|NCT00536198|3189284|Superiority or Other||Mean Difference (Net)|0.59||||0.056|2-Sided|95.0|0.3|1.19|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo|
1732279|NCT00536198|3189284|Superiority or Other|||||||0.28|||||||Chi-squared|||Group by time: comparison rates of change|
1732280|NCT00536198|3189284|Superiority or Other||||||<|0.001|||||||Chi-squared|||Change over time in both groups|
1732281|NCT00536198|3189284|Superiority or Other||||||<|0.01|||||||Chi-squared|||Group comparison|
1732282|NCT00536198|3189285|Superiority or Other||Mean Difference (Net)|1.02||||0.84|2-Sided|95.0|0.83|1.26|||Mixed Models Analysis|||Estimated mean difference from Cycle 1 to end point between active vs. placebo|
1740688|NCT00442546|3202441|Superiority or Other|||||||0.2473|||||||Cochran-Mantel-Haenszel|||Discharge|
1732286|NCT00536198|3189286|Superiority or Other||Mean Difference (Net)|5.14|Standard Error of the Mean|1.62||0.0015|2-Sided|95.0|1.97|8.31|||Mixed Models Analysis|||Estimated mean difference from baseline to end point between active vs. placebo|
1732287|NCT00536198|3189286|Superiority or Other|||||||0.02|||||||ANOVA|||Group by time: comparison of rates of change|
1732288|NCT00536198|3189286|Superiority or Other||||||<|0.001|||||||ANOVA|||Change over time in both groups|
1732289|NCT00536198|3189286|Superiority or Other||||||<|0.54|||||||ANOVA|||Group comparison|
1732290|NCT00536198|3189287|Superiority or Other||Mean Difference (Net)|1.88|Standard Error of the Mean|0.95||0.049|2-Sided|95.0|0.01|3.75|||Mixed Models Analysis|||Estimated mean difference from baseline to endpoint between active vs. placebo|
1732291|NCT00536198|3189287|Superiority or Other|||||||0.06|||||||ANOVA|||Group by time: comparison of rates of change|
1732292|NCT00536198|3189287|Superiority or Other||||||<|0.001|||||||ANOVA|||Change over time in both groups|
1732293|NCT00536198|3189287|Superiority or Other||||||<|0.21|||||||ANOVA|||Group comparison|
1732294|NCT00535925|3189314|Other||Cox Proportional Hazard|0.48|||<|0.05|2-Sided||||||Regression, Cox|Cox Shared Frailty Model, adjusted for age, sex, SBP, Hb, eGFR, albuminuria, HbA1c, total cholesterol, triglycerides (log-scaled) to reduce bias risk.|||
1732295|NCT00535847|3189317|Superiority or Other||Odds Ratio (OR)|12.703|||||2-Sided|95.0|4.259|37.884||||||Stratified Analysis (Mantel-Haenszel)- The Mantel-Haenszel estimator provides an estimate of the common odds ratio for the association between eRVR and SVR across the prior response strata.|
1732296|NCT00535730|3189335|Non-Inferiority or Equivalence|The power for the noninferiority hypothesis regarding PnPs antibody titer is ~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio [concomitant/nonconcomitant] being >05.|||||<|0.001||||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 22F at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.|
1732297|NCT00535730|3189336|Non-Inferiority or Equivalence|The power for the noninferiority hypothesis regarding PnPs antibody titer is ~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio [concomitant/nonconcomitant] being >05.|||||<|0.001||||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 19A at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.|
1732298|NCT00535730|3189337|Non-Inferiority or Equivalence|The power for the noninferiority hypothesis regarding PnPs antibody titer is ~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio [concomitant/nonconcomitant] being >05.|||||<|0.001||||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the PnPs antibody responses to serotype 14 at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who receive ZOSTAVAX™ nonconcomitantly.|
1732299|NCT00535730|3189338|Non-Inferiority or Equivalence|The power for the noninferiority hypothesis regarding PnPs antibody titer is ~99%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval (CI) on the PnPs antibody GMT ratio [concomitant/nonconcomitant] being >05.|||||<|0.001||||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||"The hypothesis was that the GMT of the PnPs antibody response to serotype 3 at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to those in subjects who~receive ZOSTAVAX™ nonconcomitantly."|
1732300|NCT00535730|3189339|Superiority or Other||||||<|0.001||||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|t-test, 1 sided|The one-sided p-value for testing acceptability for GMFR is computed based on t-test. CI is computed based on the t distribution||The hypothesis was that ZOSTAVAX™ elicits an acceptable VZV antibody response when administered concomitantly with PNEUMOVAX™ 23.|
1732301|NCT00535730|3189341|Non-Inferiority or Equivalence|The power for the noninferiority hypothesis of VZV antibody titers is 92%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval on the VZV antibody GMT ratio[concomitant/nonconcomitant] being >0.67.||||||0.244||||||The threshold for statistical significance is 0.025. There is no adjustment for multiple comparisons.|longitudinal regression model|Week 4 postvac, estimated responses, GMT ratio, 95% CI, p-value based on a longitudinal regression model adjusting for prevac titers and age (years)||The hypothesis was that the GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 will be noninferior to that in subjects who receive ZOSTAVAX™ nonconcomitantly|
1732302|NCT00535626|3189345|Other|To test whether the change from the pre-operative LEAS compared to the 5 year LEAS is statistically significant.||||||0.0009|||||||t-test, 2 sided|Paired t-test|||
1732303|NCT00535626|3189345|Other|To test whether the change from the pre-operative LEAS compared to the 4 year LEAS is statistically significant.||||||0.0002|||||||t-test, 2 sided|Paired t-test|||
1732304|NCT00535626|3189345|Other|To test whether the change from the pre-operative LEAS compared to the 1, 2 and 3 year LEAS are statistically significant.|||||<|0.0001||||||This p-value applies to pre-op to 1, 2 and 3 year intervals.|t-test, 2 sided|Paired t-test|||
1732305|NCT00535626|3189345|Other|To test whether the change from the pre-operative LEAS Score compared to the 3 month LEAS Score is statistically significant.|||||<|0.0011|||||||t-test, 2 sided|Paired t-test|||
1732306|NCT00535626|3189348|Other|To test whether the change from the pre-operative SF-36 Mental Score compared to the 5 year SF-36 Mental Score is statistically significant.||||||0.048|||||||t-test, 2 sided|Paired t-test|||
1732307|NCT00535626|3189348|Other|To test if the change from the pre-operative SF-36 Mental Score compared to the 4 year SF-36 Mental Score is statistically significant.||||||0.0909|||||||t-test, 2 sided|Paired t-test|||
1732308|NCT00535626|3189348|Other|To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 year SF-36 Mental Score is statistically significant.||||||0.0936|||||||t-test, 2 sided|Paired t-test|||
1732309|NCT00535626|3189348|Other|To test whether the change from the SF-36 Mental Score compared to the 2 year SF-36 Mental Score is statistically significant.||||||0.1506|||||||t-test, 2 sided|Paired t-test|||
1732310|NCT00535626|3189348|Other|To test whether the change from the pre-operative SF-36 Mental Score compared to the 1 year SF-36 Mental Score is statistically significant.||||||0.0254|||||||t-test, 2 sided|Paired t-test|||
1732311|NCT00535626|3189348|Other|To test whether the change from the pre-operative SF-36 Mental Score compared to the 3 month SF-36 Mental Score is statistically significant.||||||0.0139|||||||t-test, 2 sided|Paired t-test|||
1732312|NCT00535626|3189348|Other|To test whether the change from the pre-operative SF-36 Physical Score compared to each post-operative SF-36 Physical score is statistically significant.|||||<|0.0001||||||This p-value applies to all intervals.|t-test, 2 sided|Paired t-test|||
1732313|NCT00535626|3189349|Other|To test if the change from the pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.|||||<|0.0001||||||This p-value applies to all intervals.|t-test, 2 sided|Paired t-test|||
1732314|NCT00535626|3189350|Other|"To test if revision rate at 5 years is less than 10% (Ha - Alternative Hypothesis).~Note: All cases enrolled in the study had to undergo revision whether from their primary procedure or a previous revision. Based on literature, 10% is the expected rate of another revision occurring in this cohort of enrolled patients."|Revision or Pending Revision Rate|2.43|||||2-Sided|90.0|1.07|5.46|||||The estimated 2.43% revision rate was obtained by the Kaplan-Meier method.||
1732315|NCT00535587|3189355|Superiority or Other||Median Difference (Final Values)|0.05|Standard Deviation|2.94|<|0.02|2-Sided|95.0|||||ANCOVA||||
1732316|NCT00535405|3189364|Superiority or Other||Ratio of odds|1.78|Standard Error of the Mean|0.44||0.039|2-Sided|95.0|1.1|2.9||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732317|NCT00535405|3189364|Superiority or Other||Ratio of odds|1.67|Standard Error of the Mean|0.47||0.069||95.0|0.96|2.6||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732318|NCT00535405|3189364|Superiority or Other||Ratio of odds|6.02|Standard Error of the Mean|2.45|<|0.001||95.0|2.71|13.38||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732319|NCT00535405|3189365|Superiority or Other||Ratio of odds|2.15|Standard Error of the Mean|0.46|<|0.001||95.0|1.42|3.27||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732320|NCT00535405|3189365|Superiority or Other||Ratio of odds|2.95|Standard Error of the Mean|0.69|<|0.001||95.0|1.86|4.67||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732321|NCT00535405|3189365|Superiority or Other||Ratio of odds|7.6|Standard Error of the Mean|2.2|<|0.001||95.0|4.31|13.42||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732322|NCT00535405|3189366|Superiority or Other||Ratio of odds|2.27|Standard Error of the Mean|0.71||0.017||95.0|1.23|4.18||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732323|NCT00535405|3189366|Superiority or Other||Ratio of odds|1.77|Standard Error of the Mean|0.46||0.026||95.0|1.07|2.94||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732324|NCT00535405|3189366|Superiority or Other||Ratio of odds|4.47|Standard Error of the Mean|1.1|<|0.001||95.0|2.76|7.24||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732325|NCT00535405|3189367|Superiority or Other||Ratio of odds|1.81|Standard Error of the Mean|0.43||0.023||95.0|1.14|2.87||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732346|NCT00535288|3189388|Superiority or Other||Difference between least squares means|-0.07|||<|0.01|2-Sided|95.0|-0.13|-0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity|||
1732326|NCT00535405|3189367|Superiority or Other||Ratio of odds|1.54|Standard Error of the Mean|0.32||0.039||95.0|1.02|2.32||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732327|NCT00535405|3189367|Superiority or Other||Ratio of odds|3.05|Standard Error of the Mean|0.62|<|0.001||95.0|2.04|4.55||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732328|NCT00535405|3189368|Superiority or Other||Ratio of odds|3.66|Standard Error of the Mean|0.79|<|0.001||95.0|2.39|5.6|||Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732329|NCT00535405|3189368|Superiority or Other||Ratio of odds|3.83|Standard Error of the Mean|0.83|<|0.001||95.0|2.51|5.85||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732330|NCT00535405|3189368|Superiority or Other||Ratio of odds|12.62|Standard Error of the Mean|3.23|<|0.001||95.0|7.64|20.83||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|Logistic Regression using GEE|"Model include terms for treatment, baseline LDL-C, study week and treatment by study week interaction.~Generalized Estimating Equations (GEE)"|Ratio of odds of achieving pre-specified LDL-C level on EZ/Simva versus Atorva||
1732331|NCT00535405|3189369|Superiority or Other||Mean Difference (Final Values)|-8.2|Standard Error of the Mean|1.4|<|0.001||95.0|-11.0|-5.5||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.|||
1732332|NCT00535405|3189369|Superiority or Other||Mean Difference (Final Values)|-7.5|Standard Error of the Mean|1.4|<|0.001||95.0|-10.3|-4.8||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.|||
1732333|NCT00535405|3189369|Superiority or Other||Mean Difference (Final Values)|-14.7|Standard Error of the Mean|1.4|<|0.001||95.0|-17.5|-12.0||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANCOVA|ANCOVA mixed model with fixed effects for treatment, baseline LDL-C, study week, treatment by study week interaction, and a random subject effect.|||
1732334|NCT00535301|3189373|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1732335|NCT00535301|3189374|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1732336|NCT00535301|3189375|Superiority or Other||Odds Ratio (OR)|0.24|Standard Deviation|2.0||0.005|2-Sided|95.0|0.1|0.6|||Chi-squared|||Sample size was calculated based on previously-published anatomic success rates of standard anterior colporrhaphy (50%) and polypropylene mesh-reinforced anterior vaginal repair (85%) (1-10). Assuming a 2-sided hypothesis test with 5% type I error and 80% power, 33 patients in each group would be required to detect an absolute difference of 35% or more in recurrent stage II prolapse. Assuming a 15% drop-out rate, we sought to enroll 76 patients into the clinical trial.|
1732337|NCT00535288|3189384|Superiority or Other||Difference between least squares means|-0.07||||0.02|2-Sided|95.0|-0.14|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity|||
1732338|NCT00535288|3189384|Superiority or Other||Difference between least squares means|-0.04||||0.29|2-Sided|95.0|-0.11|0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity|||
1732339|NCT00535288|3189384|Superiority or Other||Difference between least squares means|-0.05||||0.24|2-Sided|95.0|-0.11|0.02||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity|||
1732340|NCT00535288|3189384|Superiority or Other||Difference between least squares means|-0.06||||0.07|2-Sided|95.0|-0.12|0.0||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity|||
1732341|NCT00535288|3189387|Superiority or Other||Difference between least squares means|-2.0|||<|0.01|2-Sided|95.0|-3.1|-0.9||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency|||
1732342|NCT00535288|3189387|Superiority or Other||Difference between least squares means|-1.5|||<|0.01|2-Sided|95.0|-2.7|-0.4||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency|||
1732343|NCT00535288|3189387|Superiority or Other||Difference between least squares means|-1.6|||<|0.01|2-Sided|95.0|-2.7|-0.5||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency|||
1732344|NCT00535288|3189387|Superiority or Other||Difference between least squares means|-1.0|||<|0.08|2-Sided|95.0|-2.1|0.1||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency|||
1732345|NCT00535288|3189388|Superiority or Other||Difference between least squares means|-0.08|||<|0.01|2-Sided|95.0|-0.14|-0.03||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity|||
1732347|NCT00535288|3189388|Superiority or Other||Difference between least squares means|-0.06|||<|0.02|2-Sided|95.0|-0.11|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity|||
1732348|NCT00535288|3189388|Superiority or Other||Difference between least squares means|-0.07|||<|0.01|2-Sided|95.0|-0.12|-0.01||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline severity|||
1732349|NCT00535288|3189389|Superiority or Other||Difference between least squares means|-1.9|||<|0.01|2-Sided|95.0|-2.9|-0.9||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency|||
1732350|NCT00535288|3189389|Superiority or Other||Difference between least squares means|-1.4|||<|0.01|2-Sided|95.0|-2.4|-0.4||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency|||
1732351|NCT00535288|3189389|Superiority or Other||Difference between least squares means|-1.7|||<|0.01|2-Sided|95.0|-2.7|-0.7||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency|||
1732352|NCT00535288|3189389|Superiority or Other||Difference between least squares means|-1.2|||<|0.01|2-Sided|95.0|-2.2|-0.2||Confidence intervals and p-values were adjusted by (2-sided) Dunnett many-to-one comparison at 0.05 overall Type 1 error rate.|ANCOVA|Factors for treatment group and (pooled) center and a covariate for the baseline frequency|||
1732353|NCT00535236|3189391|Other||Difference in Percentages|3.8||||0.679|2-Sided|95.0|-18.5|18.2|||Asymptotic method||V212 minus placebo = Difference||
1732354|NCT00535236|3189391|Other||Difference in Percentages|6.8||||0.402|2-Sided|95.0|-13.7|19.1|||Asymptotic method||V212 minus placebo = Difference||
1732355|NCT00535236|3189391|Other||Difference in Percentages|7.5||||0.221|2-Sided|95.0|-9.8|18.0|||Asymptotic method||V212 minus placebo = Difference||
1732356|NCT00535236|3189391|Other||Difference in Percentages|6.7||||0.696|2-Sided|95.0|-22.5|39.4|||Asymptotic method||V212 minus placebo = Difference||
1732357|NCT00535236|3189391|Other||Difference in Percentages|10.5||||0.552|2-Sided|95.0|-21.3|41.8|||Asymptotic method||V212 minus placebo = Difference||
1732358|NCT00535236|3189392|Other||Difference in Percentages|0.0|||>|0.999|2-Sided|95.0|-19.2|10.0|||Asymptotic method||V212 minus placebo = Difference||
1732359|NCT00535236|3189392|Other||Difference in Percentages|4.9|||>|0.328|2-Sided|95.0|-12.3|13.6|||Asymptotic method||V212 minus placebo = Difference||
1732360|NCT00535236|3189392|Other||Difference in Percentages|3.5|||>|0.411|2-Sided|95.0|-13.7|12.0|||Asymptotic method||V212 minus placebo = Difference||
1732361|NCT00535236|3189392|Other||Difference in Percentages|2.5|||>|0.617|2-Sided|95.0|-25.8|13.0|||Asymptotic method||V212 minus placebo = Difference||
1732362|NCT00535236|3189392|Other||Difference in Percentages|-5.0|||>|0.556|2-Sided|95.0|-36.3|9.5|||Asymptotic method||V212 minus placebo = Difference||
1732363|NCT00535236|3189393|Other||Difference in Percentages|-11.7||||0.064|2-Sided|95.0|-33.2|0.6|||Asymptotic method||V212 minus placebo = Difference||
1732364|NCT00535236|3189393|Other||Difference in Percentages|22.6||||0.041|2-Sided|95.0|1.3|36.6|||Asymptotic method||V212 minus placebo = Difference||
1732365|NCT00535236|3189393|Other||Difference in Percentages|31.6||||0.009|2-Sided|95.0|9.7|46.2|||Asymptotic method||V212 minus placebo = Difference||
1732366|NCT00535236|3189393|Other||Difference in Percentages|10.0||||0.302|2-Sided|95.0|-18.8|23.2|||Asymptotic method||V212 minus placebo = Difference||
1732367|NCT00535236|3189393|Other||Difference in Percentages|0.0|||>|0.999|2-Sided|95.0|-31.7|16.5|||Asymptotic method||V212 minus placebo = Difference||
1732368|NCT00535236|3189394|Other||Difference in Percentages|3.3|||||2-Sided|95.0|-18.1|17.0|||||V212 minus placebo = Difference||
1732369|NCT00535236|3189394|Other||Difference in Percentages|14.4|||||2-Sided|95.0|-6.5|27.6|||||V212 minus placebo = Difference||
1732370|NCT00535236|3189394|Other||Difference in Percentages|1.8|||||2-Sided|95.0|-20.4|15.7|||||V212 minus placebo = Difference||
1732371|NCT00535236|3189394|Other||Difference in Percentages|10.0|||||2-Sided|95.0|-15.1|42.9|||||V212 minus placebo = Difference||
1732372|NCT00535236|3189394|Other||Difference in Percentages|12.5|||||2-Sided|95.0|-21.7|35.3|||||V212 minus placebo = Difference||
1732373|NCT00535236|3189395|Other|||||||0.026||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being >1.0|Single longitudinal regression model|Adjusted for prevaccination values|||
1732374|NCT00535236|3189395|Other|||||||0.004||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the geometric mean fold rise (GMFR) in the vaccine recipients being >1.0|Single longitudinal regression model|Adjusted for prevaccination values|||
1732375|NCT00535236|3189395|Other||||||<|0.001||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being >1.0|Single longitudinal regression model|Adjustied for prevaccination values|||
1732376|NCT00535236|3189396|Other|||||||0.017||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being >1.0|Single longitudinal regression model|Adjusted for prevaccination values|||
1732377|NCT00535236|3189396|Other|||||||0.003||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being >1.0|Single longitudinal regression model|Adjusted for prevaccination values|||
1732378|NCT00535236|3189396|Other||||||<|0.001||||||Statistical criterion corresponds to the lower bound of the two-sided 90% confidence interval (CI) on the GMFR in the vaccine recipients being >1.0|Single longitudinal regression model|Adjusted for prevaccination values|||
1741648|NCT00432809|3203956|Superiority or Other|||||||0.001|||||||ANOVA||||
1732379|NCT00535132|3189403|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Deviation|3.0|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.|||
1732380|NCT00535132|3189404|Superiority or Other||Mean Difference (Final Values)|-2.3|Standard Deviation|4.3|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.|||
1732381|NCT00535132|3189405|Superiority or Other||Mean Difference (Final Values)|7.0|Standard Deviation|10.4|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.|||
1732382|NCT00535132|3189406|Superiority or Other||Mean Difference (Final Values)|1.5|Standard Deviation|7.5||0.009|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.|||
1732383|NCT00535132|3189407|Superiority or Other||Mean Difference (Final Values)|28.3|Standard Deviation|23.1|<|0.001||||||p-value for within-group comparison based on a paired t-test.|t-test, 2 sided||||
1732384|NCT00535132|3189408|Superiority or Other|||||||0.125|||||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.|||
1732385|NCT00535132|3189409|Superiority or Other|||||||0.123||||||P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.|Fisher Exact||||
1732386|NCT00535132|3189410|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Deviation|0.9|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.|||
1732387|NCT00535132|3189411|Superiority or Other||Mean Difference (Final Values)|-12.9|Standard Deviation|13.1|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.|||
1732388|NCT00535132|3189412|Superiority or Other|||||||0.033|||||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.|||
1732389|NCT00535132|3189413|Superiority or Other|||||||0.002|||||||Fisher Exact|P-values for the study group comparisons using dichotomized categories are based on Fisher's Exact Test.|||
1732390|NCT00535132|3189414|Superiority or Other||Mean Difference (Final Values)|2.5|Standard Deviation|1.3|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.|||
1732391|NCT00535132|3189415|Superiority or Other||Mean Difference (Final Values)|2.3|Standard Deviation|1.4|<|0.001|||||||t-test, 2 sided||||
1732392|NCT00535132|3189416|Superiority or Other||Mean Difference (Final Values)|1.8|Standard Deviation|1.4|<|0.001|||||||t-test, 2 sided|p-value for within-group comparison based on a paired t-test.|||
1732393|NCT00535132|3189417|Superiority or Other||Mean Difference (Final Values)|2.4|Standard Deviation|1.4|<|0.001||||||p-value based on a paired t-test for a within-group comparison.|t-test, 2 sided|||Sample size for this study was based on changes in the MSQ scores within subjects from baseline to endpoint using a one-sample paired t-test. A sample size of 97 subjects was shown to have 90% power at endpoint to detect a mean change from baseline of 0.5 units on the MSQ score, with a standard deviation of 1.5. Allowing for extra variability from subjects with prior generic risperidone (instead of branded risperidone) use, this number was increased to 150 subjects.|
1732394|NCT00534976|3189419|Superiority or Other||Difference in Proportions|-3.2||||||95.0|||||||Montelukast minus placebo||
1732395|NCT00534976|3189420|Superiority or Other||Difference in Proportions|-1.6||||1||95.0||||P-value provided is for comparison between the two proportions: Montelukast versus placebo.|McNemar||Montelukast minus placebo||
1732396|NCT00534976|3189421|Superiority or Other||Difference in least square means|-7.06||||0.054||95.0|||||ANOVA||Montelukast minus Placebo||
1732397|NCT00534976|3189422|Superiority or Other||Difference in least square means|-8.27||||0.064||95.0|||||ANOVA||Montelukast minus placebo||
1732398|NCT00534976|3189423|Superiority or Other||Difference in least square means|-122.82||||0.013||95.0|||||ANOVA||Montelukast minus placebo||
1732399|NCT00534976|3189424|Superiority or Other||Difference in least square means|-120.86||||0.022||95.0|||||ANOVA||Montelukast minus placebo||
1732400|NCT00534976|3189425|Superiority or Other||Difference in least square means|-4.33||||0.005||95.0|||||ANOVA||Montelukast minus placebo||
1732401|NCT00534976|3189426|Superiority or Other||Difference in least square means|-4.65||||0.02||95.0|||||ANOVA||Montelukast minus placebo||
1732402|NCT00534794|3189434|Superiority or Other|||||||0.927|||||||Student's t-test|||ITT (Intent to Treat)|
1732403|NCT00534794|3189435|Superiority or Other|||||||0.532|||||||ANCOVA|||ITT (Intent to Treat)|
1732404|NCT00534638|3189456|Superiority||Vaccine effectiveness percentage|-52.2||||0.069|2-Sided|95.0|-139.4|3.3||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Cervarix/Engerix-B B Group: The analysis of the overall effectiveness of GSK’s HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Cervarix/Engerix-B B was based on stratified Mantel-Haenszel adjusted for clustering.|
1732405|NCT00534638|3189457|Superiority||Vaccine effectiveness percentage|23.8||||0.232|2-Sided|95.0|-19.0|51.1||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK’s HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.|
1732406|NCT00534638|3189457|Superiority||Vaccine effectiveness percentage|49.6||||0.004|2-Sided|95.0|20.1|68.2||An objective was reached if the 2-sided p-value associated to the objective was below 5%.|Cochran-Mantel-Haenszel|||Overall efectiveness against HPV-16/18 Cervarix/Engerix-B B Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK’s HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B B Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.|
1732407|NCT00534365|3189491|Superiority or Other|||||||0.015|||||||t-test, 2 sided||||
1732408|NCT00534365|3189492|Superiority or Other|||||||0.64|||||||t-test, 2 sided||||
1732435|NCT00533949|3189618|Superiority||Cox Proportional Hazard|1.0||||0.79|2-Sided|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of time to distant metastasis by PET SUV as a continuous variable|
1741649|NCT00432809|3203957|Superiority or Other|||||||0.46|||||||ANOVA||||
1732409|NCT00534365|3189495|Non-Inferiority or Equivalence|We chose a non-inferiority margin of 12% based on previously published multicenter trial of mid-urethral slings. Assuming subjective cure rate for TVT of 82%, 127 individuals in each group will provide 80% to reject the null hypothesis that the true difference in cure rates between the two procedures is less than or equal to 2% using a two group large sample normal approximation test of proportions with a one sided 0.05 significance level.||||||0.43|||||||Regression, Logistic||||
1732410|NCT00534352|3189507|Non-Inferiority or Equivalence|Equivalence was shown for Css,av as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|99.3||||||90.0|89.39|110.3|||||The results are for the mean ratio of Css,av. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.|
1732411|NCT00534352|3189507|Non-Inferiority or Equivalence|Equivalence was shown for AUC24 as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|LS means of ratios|98.97||||||90.0|89.23|109.8|||||The results are for the mean ratio of AUC24. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.|
1732412|NCT00534352|3189507|Non-Inferiority or Equivalence|Equivalence was shown for Cmax as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|102.6||||||90.0|92.91|113.3|||||The results are for the mean ratio of Cmax. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.|
1732413|NCT00534352|3189507|Non-Inferiority or Equivalence|Equivalence was shown for Cmin as the 90% confidence intervals (CI) of the LSmean ratio was within the 80-125% limits.|Least Square (LS) mean ratio|95.47||||||90.0|82.77|110.1|||||The results are for the mean ratio of Cmin. Numerator: Treatment B Denominator: Treatment A|Previous studies showed that the intrasubject variability on the log transformed Cmax and AUC12h of TMC125 was less than or equal to 40%. Based on this and with complete data on 20 patients, the 90% CI of the true ratio of the means was expected to be contained within 81-124% of the observed ratio of the means.|
1732414|NCT00534313|3189508|Superiority or Other||Difference|16.6||||||95.0|-1.8|34.9|||||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.||
1732415|NCT00534313|3189508|Superiority or Other||Difference|26.1||||||95.0|6.8|45.5|||||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.||
1732416|NCT00534313|3189508|Superiority or Other||Difference|16.0|||||2-Sided|95.0|-2.5|34.5|||||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.||
1732417|NCT00534313|3189509|Superiority or Other||Mean Difference (Net)|6.17|||||2-Sided|95.0|1.01|11.32|||||||
1732418|NCT00534313|3189509|Superiority or Other||Mean Difference (Net)|9.12|||||2-Sided|95.0|3.83|14.41|||||||
1732419|NCT00534313|3189509|Superiority or Other||Mean Difference (Net)|7.15|||||2-Sided|95.0|1.97|12.33|||||||
1732420|NCT00534313|3189513|Superiority or Other||Mean Difference (Net)|0.75|||||2-Sided|95.0|-6.08|7.58|||||||
1732421|NCT00534313|3189513|Superiority or Other||Mean Difference (Net)|2.01|||||2-Sided|95.0|-4.94|8.95|||||||
1732422|NCT00534313|3189513|Superiority or Other||Mean Difference (Net)|2.08||||||95.0|-4.79|8.96|||||||
1732423|NCT00534313|3189515|Superiority or Other||Mean Difference (Final Values)|30.48|||||2-Sided|95.0|4.82|56.15|||||||
1732424|NCT00534313|3189515|Superiority or Other||Mean Difference (Final Values)|22.34|||||2-Sided|95.0|-3.93|48.6|||||||
1732425|NCT00534313|3189515|Superiority or Other||Mean Difference (Final Values)|18.77|||||2-Sided|95.0|-7.02|44.56|||||||
1732426|NCT00534313|3189516|Superiority or Other||Difference|10.4|||||2-Sided|95.0|-7.6|28.5|||||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.||
1732427|NCT00534313|3189516|Superiority or Other||Difference|-0.5|||||2-Sided|95.0|-18.0|17.1|||||Difference and 95% CI was based on CMH with stratification of baseline BSA affected by psoriasis.||
1732428|NCT00534313|3189516|Superiority or Other||Difference|-6.0|||||2-Sided|95.0|-23.0|11.0|||||Difference and 95% confidence intervals (CI) was based on CMH with stratification of baseline BSA affected by psoriasis.||
1732429|NCT00534313|3189523|Superiority or Other||Difference|14.6||||0.121|2-Sided|95.0|-3.5|32.6||p-value (2-sided) was based on CMH with stratification of baseline BSA affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.||
1732430|NCT00534313|3189523|Superiority or Other||Difference|28.7||||0.006|2-Sided|95.0|9.4|48.0||p-value (two-sided) was based on CMH with stratification of baseline BSA affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.||
1732431|NCT00534313|3189523|Superiority or Other||Difference|22.9||||0.022|2-Sided|95.0|4.0|41.8||The p-value (two-sided) was based on Cochran-Mantel-Haenszel method (CMH) with stratification of baseline body surface area (BSA) affected by psoriasis.|Cochran-Mantel-Haenszel||Difference was based on CMH with stratification of baseline BSA affected by psoriasis.||
1732432|NCT00534248|3189531|Superiority or Other||Relative Risk|1.133|||||2-Sided|95.0|0.805|1.595||||||Analysis of proportion of participants reporting one or more serious adverse experiences reported within 42 days postvaccination.|
1732433|NCT00534248|3189532|Superiority or Other||geometric mean titre ratio|2.3|||<|0.001|2-Sided|95.0|2.2|2.4|||linear mixed longitudinal analysis model||||
1732434|NCT00534248|3189533|Superiority or Other||point estimate|0.698|||<|0.001|2-Sided|95.0|0.541|0.806|||Conditional Exact Method||The point estimate was for vaccine efficacy with respect to incidence of HZ.|Vaccine efficacy with respect to HZ was defined as the relative reduction in incidence rate of HZ point estimate (95% CI) calculated as 1 minus the ratio of the estimated incidence rates of HZ in the zoster vaccine group and the placebo group.|
1732436|NCT00533949|3189618|Superiority||Cox Proportional Hazard|1.0||||0.72|2-Sided|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of time to local-regional failure by PET SUV as a continuous variable|
1732437|NCT00533949|3189618|Superiority||Cox Proportional Hazard|1.0||||0.94|2-Sided|95.0|0.98|1.02|||Regression, Cox||Corresponding to a one unit increase in SUV|Univariate model of overall survival time by PET SUV as a continuous variable|
1732438|NCT00533949|3189619|Superiority||Hazard Ratio (HR)|1.001||||0.78|2-Sided|95.0|0.997|1.004||Two-sided significance level = 0.05|Regression, Cox||Corresponding to a one unit increase in GTV|Multivariate model with GTV as a continuous variable, adjusting for planned radiation therapy dose group (60 Gy or 74 Gy) and the interaction of GTV and planned dose.|P-Value for the interaction of GTV and planned dose = 0.77
1732439|NCT00533949|3189619|Other||Cox Proportional Hazard|1.001||||0.06|2-Sided|95.0|1.0|1.002||Two-sided significance level = 0.05|Regression, Cox||Corresponding to a one unit increase in GTV|Univariate model with GTV as a continuous variable|
1732440|NCT00533949|3189620|Superiority|||||||0.02||||||Two-sided significance level = 0.05|Chi-squared||||
1732441|NCT00533949|3189621|Superiority||Hazard Ratio (HR)|1.11||||0.61|2-Sided|95.0|0.74|1.65|||Regression, Cox||Reference level = EGFR H-Score < 200|Univariate model of time to local-regional failure by EGFR group|
1732442|NCT00533949|3189621|Superiority||Hazard Ratio (HR)|0.95||||0.78|2-Sided|95.0|0.68|1.33|||Regression, Cox||Reference level = EGFR H-Score < 200|Univariate model of overall survival by EGFR group|
1732443|NCT00533949|3189622|Superiority|||||||0.19|||||||t-test, 2 sided|Two-sided significance level = 0.05|||
1732444|NCT00533949|3189623|Superiority|||||||0.92|||||||t-test, 2 sided|Two-sided significance level = 0.05|||
1732445|NCT00533949|3189624|Superiority or Other (legacy)|||||||0.0233|||||||Cochran-Mantel-Haenszel|||FACT-TOI-LCS was assessed and changes from baseline to 3 months calculated and grouped using a 2 point decline as the threshold. Comparisons of decline vs no decline by RT level were from a Cochran-Mantel-Haenszel test and controlling for cetuximab assignment using a two-side significance level of 0.05.|
1732446|NCT00533949|3189626|Superiority or Other (legacy)|||||||0.52|||||||Chi-squared|||Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of of toxicity at any time was classified by a binary grouping of < grade 3 and >= grade 3. Comparisons were made using a two-sided chi-square test.|
1732447|NCT00533949|3189627|Superiority or Other (legacy)|||||||0.2533|||||||Chi-squared|||PNEUMONITIS: Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of esophagitis and the worst grade of pneumonitis at any time were classified by binary groupings of < grade 3 and >= grade 3. Comparisons were made using a two-sided chi-square test with a significance level of 0.05.|
1732448|NCT00533949|3189627|Superiority or Other (legacy)||||||<|0.0001|||||||Chi-squared|||Esophagitis: Only those toxicities reported as possibly, probably, or definitely related to treatment were considered. The worst grade of esophagitis and the worst grade of pneumonitis at any time were classified by binary groupings of < grade 3 and >= grade 3. Comparisons were made using a two-sided chi-square test with a significance level of 0.05.|
1732449|NCT00533949|3189628|Superiority or Other (legacy)||Hazard Ratio (HR)|0.84||||0.22|2-Sided|95.0|0.64|1.1|||Gray's test||Reference level = cetuximab|Local-regional failure was estimated by the cumulative incidence method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.|
1732450|NCT00533949|3189628|Superiority or Other (legacy)||Hazard Ratio (HR)|1.17||||0.24|2-Sided|95.0|0.89|1.53|||Gray's test||Reference level = 60 Gy|Local-regional failure was estimated by the cumulative incidence method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.|
1732451|NCT00533949|3189629|Superiority or Other (legacy)||Hazard Ratio (HR)|0.99||||0.89|2-Sided|95.0|0.8|1.22|||Log Rank||Reference level = cetuximab|Progression-free survival is estimated by the Kaplan-Meier method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05.|
1732452|NCT00533949|3189629|Superiority or Other (legacy)||Hazard Ratio (HR)|1.19||||0.12|2-Sided|95.0|0.95|1.47|||Log Rank||Reference level = 60 Gy|Progression-free survival is estimated by the Kaplan-Meier method. Comparisons by RT level and by cetuximab assignment are performed separately and tested with a two-sided significance level of 0.05 for each comparison.|
1732453|NCT00533949|3189630|Superiority or Other (legacy)||Hazard Ratio (HR)|1.07||||0.29|2-Sided|95.0|0.84|1.35|||Log Rank||Reference level = cetuximab|The trial was a two-by-two factorial design with radiation therapy dose as one treatment factor and cetuximab as the other. A log-rank test for each factor at one-sided α of 0.0125 (α of 0.0250 for both factors to account for multiple comparisons) would yield power of 80% to detect an improvement in median survival from 17.1 to 24 months after 339 deaths were reported out of 500 patients. For RT analysis, the comparison was arms 1 & 3 vs arms 2 & 4; for cetuximab, arms 1 & 2 vs arms 3 & 4.|
1732454|NCT00533949|3189630|Superiority or Other (legacy)||Hazard Ratio (HR)|1.38||||0.0042|2-Sided|95.0|1.09|1.76|||Log Rank||Reference group = 60 gy|The trial was a two-by-two factorial design with radiation therapy dose as one treatment factor and cetuximab as the other. A log-rank test for each factor at one-sided α of 0.0125 (α of 0.0250 for both factors to account for multiple comparisons) would yield power of 80% to detect an improvement in median survival from 17.1 to 24 months after 339 deaths were reported out of 500 patients. For RT analysis, the comparison was arms 1 & 3 vs arms 2 & 4; for cetuximab, arms 1 & 2 vs arms 3 & 4.|
1732455|NCT00533897|3189692|Superiority or Other||Estimate of Difference|0.11|||||2-Sided|95.0|-8.21|8.43||||||Immunogenicity rates of the Period II treatment groups on Day 253 were analyzed similarly as on Day 169. However, no statistical test was carried out and no p-value was provided. Provided were: point estimates of the immunogenicity rates within the Period II treatment groups and corresponding 95% CIs, and point estimate for the difference in immunogenicity rates between these groups and corresponding 95% CI. There was no adjustment made for multiple comparisons.|
1732491|NCT00532779|3189771|Superiority or Other||Mean Difference (Net)|0.9|||||2-Sided|95.0|0.13|1.67||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732536|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at Cycle 11.|
1732456|NCT00533897|3189696|Superiority or Other||Estimate of Difference|4.88|||||2-Sided|95.0|-4.5|14.25||||||Immunogenicity rates of the Period II treatment groups on Day 253 were analyzed similarly as on Day 169. However, no statistical test was carried out and no p-value was provided. Provided were: point estimates of the immunogenicity rates within the Period II treatment groups and corresponding 95% CIs, and point estimate for the difference in immunogenicity rates between these groups and corresponding 95% CI. There was no adjustment made for multiple comparisons.|
1732457|NCT00533897|3189697|Superiority or Other||estimate of difference|9.59||||0.119|2-Sided|95.0|0.83|18.34||There was no adjustment made for multiple comparisons.|Chi-squared, Corrected|||A continuity corrected Chi-square test was used to compare percentage of positive antibody responses of SC placebo vs. SC abatacept (Period II treatment groups) on Day 169. P-value was evaluated at 0.05 significance level (2-sided). 95% confidence interval (CI) for difference (SC PLA - SC ABA) between ABA and PLA in the immunogenicity rates was also calculated. Point estimates of the immunogenicity rates within the two Period II treatment group and the corresponding 95% CIs were also provided.|
1732458|NCT00533845|3189698|Superiority or Other|||||||0.0022|||||||t-test, 2 sided||||
1732459|NCT00533442|3189729|Superiority|||||||0.75|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 60 Months Post-Transplant (t-test).|
1732460|NCT00533442|3189729|Superiority|||||||0.97|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 36 Months Post-Transplant (t-test).|
1732461|NCT00533442|3189729|Superiority|||||||0.47|||||||t-test, 2 sided|||Comparison of Mean Log {C-Peptide Level} at 12 Months Post-Transplant (t-test).|
1732462|NCT00533442|3189730|Superiority|||||||0.33|||||||t-test, 2 sided|||Comparison of Mean eGFR at 60 Months Post-Transplant (t-test).|
1732463|NCT00533442|3189730|Superiority|||||||0.71|||||||t-test, 2 sided|||Comparison of Mean eGFR at 36 Months Post-Transplant (t-test).|
1732464|NCT00533442|3189730|Superiority|||||||0.21|||||||t-test, 2 sided|||Comparison of Mean eGFR at 12 Months Post-Transplant (t-test).|
1732465|NCT00533442|3189731|Superiority||||||>|0.99||||||Patient Death (logrank test).|Log Rank||||
1732466|NCT00533442|3189731|Superiority||||||>|0.96|||||||Log Rank|||Death-Uncensored (Kidney & Pancreas) Graft Survival (logrank test).|
1732467|NCT00533442|3189731|Superiority||||||>|0.12|||||||Log Rank|||Death-Censored Pancreas Graft Failure (logrank test).|
1732468|NCT00533442|3189731|Superiority||||||>|0.16|||||||Log Rank|||Death-Censored Kidney Graft Failure (logrank test).|
1732469|NCT00533442|3189731|Superiority||||||>|0.01|||||||Log Rank|||Biopsy-Proven Acute Rejection of the Pancreas (logrank test).|
1732470|NCT00533442|3189731|Superiority||||||>|0.01|||||||Log Rank|||Biopsy-Proven Acute Rejection of the Kidney (logrank test).|
1732471|NCT00533273|3189743|Superiority||||||<|0.001|||||||ANOVA||||
1732472|NCT00533273|3189744|Superiority||||||<|0.001|||||||ANOVA||||
1732473|NCT00533273|3189745|Superiority||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1732474|NCT00533273|3189746|Superiority|||||||0.014|||||||Cochran-Mantel-Haenszel||||
1732475|NCT00533273|3189748|Superiority||||||<|0.001|||||||ANOVA||||
1732476|NCT00533273|3189749|Superiority||||||<|0.001|||||||ANOVA||||
1732477|NCT00533273|3189750|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1732478|NCT00533273|3189751|Superiority||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1732479|NCT00532935|3189762|Superiority or Other||Odds Ratio (OR)|2.0|||<|0.001|2-Sided|95.0|1.3|2.8||Based on a test of the odds ratio = 1, comparing the odds of having A1C <7.0% at Week 32 in the Sitagliptin/Metformin 50/1000 mg b.i.d. group vs. the Pioglitazone 45 mg q.d. group.|Regression, Logistic|logistic regression model included a term for treatment and a covariate for the baseline A1C value.|This parameter estimate and 95% confidence interval correspond to the odds of having A1C <7.0% at Week 32 in the Sitagliptin/Metformin 50/1000 mg b.i.d. group vs. the Pioglitazone 45 mg q.d. group.||
1732480|NCT00532935|3189763|Superiority or Other||Mean Difference (Net)|-11.9|Standard Deviation|40.3|<|0.001|2-Sided|95.0|-19.0|-4.9|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline FPG value.|||
1732481|NCT00532935|3189764|Superiority or Other||Mean Difference (Net)|-20.2|Standard Deviation|59.7|<|0.001|2-Sided|95.0|-32.1|-8.3|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline 2-hour PMG value.|||
1732482|NCT00532935|3189765|Superiority or Other||Mean Difference (Net)|-27.6|Standard Deviation|29.1|<|0.001|2-Sided|95.0|-32.7|-22.4|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline FPG value.|||
1732483|NCT00532935|3189766|Superiority or Other||Mean Difference (Net)|-0.47|Standard Deviation|1.1|<|0.001|2-Sided|95.0|-0.66|-0.28|||ANCOVA|ANCOVA model included a term for treatment and a covariate for the baseline A1C value.|||
1732484|NCT00532883|3189767|Superiority or Other|||||||0.93||||||This is a global test comparing all four treatment arms.|Mixed Models Analysis|||F-test from a longitudinal mixed model (controlling for baseline measurement)testing the hypothesis of no difference in mean percent dense cells between the four treatment groups at Visit 6. The study was originally powered to detect a difference of 20%, but it was stopped early.|
1732485|NCT00532779|3189768|Superiority or Other||Mean Difference (Net)|-0.27|||||2-Sided|95.0|-0.8|0.27||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732486|NCT00532779|3189768|Superiority or Other||Mean Difference (Net)|0.0|||||2-Sided|95.0|-0.53|0.53||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732487|NCT00532779|3189769|Superiority or Other||Mean Difference (Net)|0.15|||||2-Sided|95.0|-0.4|0.69||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732488|NCT00532779|3189769|Superiority or Other||Mean Difference (Net)|0.69|||||2-Sided|95.0|0.14|1.23||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732489|NCT00532779|3189770|Superiority or Other||Mean Difference (Net)|0.46|||||2-Sided|95.0|-0.09|1.0||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732490|NCT00532779|3189770|Superiority or Other||Mean Difference (Net)|0.74|||||2-Sided|95.0|0.19|1.28||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732739|NCT00531661|3189942|Superiority or Other|||||||0.0002|||||||Negative Binomial Regression||||
1732492|NCT00532779|3189771|Superiority or Other||Mean Difference (Net)|0.96|||||2-Sided|95.0|0.19|1.73||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732493|NCT00532779|3189772|Superiority or Other||Mean Difference (Net)|1.83|||||2-Sided|95.0|0.76|2.9||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732494|NCT00532779|3189772|Superiority or Other||Mean Difference (Net)|2.23|||||2-Sided|95.0|1.16|3.3||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732495|NCT00532779|3189773|Superiority or Other||Mean Difference (Net)|-1.13||||0.484|2-Sided|95.0|-4.29|2.04|||ANCOVA||||
1732496|NCT00532779|3189773|Superiority or Other||Mean Difference (Net)|-0.39|||||2-Sided|95.0|-3.62|2.84||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732497|NCT00532779|3189774|Superiority or Other||Mean Difference (Net)|-5.84|||<|0.001|2-Sided|95.0|-8.71|-2.98|||ANCOVA||||
1732498|NCT00532779|3189774|Superiority or Other||Mean Difference (Net)|-3.81|||<||2-Sided|95.0|-6.68|-0.94||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732499|NCT00532779|3189775|Superiority or Other||Mean Difference (Net)|-14.29|||<|0.001|2-Sided||||||ANCOVA||||
1732500|NCT00532779|3189775|Superiority or Other||Mean Difference (Net)|-8.43|||<||2-Sided|||||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732501|NCT00532779|3189776|Superiority or Other||Mean Difference (Net)|-1.94|||=|0|2-Sided|95.0|-3.42|-0.46|||ANCOVA||||
1732502|NCT00532779|3189776|Superiority or Other||Mean Difference (Net)|-1.09|||=||2-Sided|95.0|-2.6|0.42||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1732503|NCT00532779|3189777|Superiority or Other||Mean Difference (Net)|-12.57|||<|0.001|2-Sided||||||ANCOVA||||
1732504|NCT00532779|3189777|Superiority or Other||Mean Difference (Net)|-7.27|||=|0|2-Sided||||||ANCOVA||||
1732505|NCT00532779|3189778|Superiority or Other||Mean Difference (Net)|-12.32|||=|0|2-Sided||||||ANCOVA||||
1732506|NCT00532779|3189778|Superiority or Other||Mean Difference (Net)|-11.36|||=|0|2-Sided||||||ANCOVA||||
1732507|NCT00532779|3189779|Superiority or Other||Mean Difference (Net)|4.14|||<|0.001|2-Sided|95.0|2.73|5.56|||ANCOVA||||
1732508|NCT00532779|3189779|Superiority or Other||Mean Difference (Net)|3.13|||<|0.001|2-Sided|95.0|1.72|4.54|||ANCOVA||||
1732509|NCT00532779|3189780|Superiority or Other||Mean Difference (Net)|-9.61|||<|0.001|2-Sided||||||ANCOVA||||
1732510|NCT00532779|3189780|Superiority or Other||Mean Difference (Net)|-4.88|||=|0|2-Sided||||||ANCOVA||||
1732511|NCT00532779|3189781|Superiority or Other||Mean Difference (Net)|3.48|||<|0.001|2-Sided|95.0|2.26|4.7|||ANCOVA||||
1732512|NCT00532779|3189781|Superiority or Other||Mean Difference (Net)|3.42|||<|0.001|2-Sided|95.0|2.17|4.66|||ANCOVA||||
1732513|NCT00532779|3189782|Superiority or Other||Mean Difference (Net)|-3.78|||<|0.001|2-Sided|95.0|-4.93|-2.64|||ANCOVA||||
1732514|NCT00532779|3189782|Superiority or Other||Mean Difference (Net)|-2.58|||<|0.001|2-Sided|95.0|-3.74|-1.43|||ANCOVA||||
1732515|NCT00532779|3189783|Superiority or Other||Odds Ratio (OR)|4.19|||<|0.001|2-Sided|95.0|2.82|6.23|||Regression, Logistic||||
1732516|NCT00532779|3189783|Superiority or Other||Odds Ratio (OR)|3.21|||<|0.001|2-Sided|95.0|2.14|4.81|||Regression, Logistic||||
1732517|NCT00532779|3189784|Superiority or Other||Odds Ratio (OR)|4.86|||<|0.001||95.0|3.6|6.57|||Regression, Logistic||||
1732518|NCT00532779|3189784|Superiority or Other||Odds Ratio (OR)|3.42|||<|0.001||95.0|2.52|4.63|||Regression, Logistic||||
1732519|NCT00532779|3189785|Superiority or Other||Mean Difference (Net)|-4.81|||<|0.001|2-Sided|95.0|-5.63|-3.99|||ANCOVA||||
1732520|NCT00532779|3189785|Superiority or Other||Mean Difference (Net)|-3.67|||<|0.001||95.0|-4.5|-2.85|||ANCOVA||||
1732521|NCT00532155|3189820|Superiority or Other||Stratified Hazard ratio|0.819||||0.0035|2-Sided|95.0|0.716|0.937|||Stratified Log-Rank test|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.||
1732522|NCT00532155|3189821|Superiority or Other||Hazard Ratio (HR)|1.01||||0.8985|2-Sided|95.0|0.868|1.174|||Stratified log-rank test|Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.|||
1732523|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in pain statistical analysis at end of FU.|
1732524|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in pain statistical analysis at Cycle 11.|
1732525|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in pain statistical analysis at Cycle 5.|
1732526|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in nausea/vomiting statistical analysis at end of FU.|
1732527|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in nausea/vomiting statistical analysis at Cycle 11.|
1732528|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in Nausea/vomiting statistical analysis at Cycle 5.|
1732529|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in fatigue statistical analysis at end of FU.|
1732530|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in fatigue functioning statistical analysis at Cycle 11.|
1732531|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in fatigue statistical analysis at Cycle 5.|
1732532|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in social functioning statistical analysis at end of FU.|
1732533|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in social functioning statistical analysis at Cycle 11.|
1732534|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in social functioning statistical analysis at Cycle 5.|
1732535|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at end of FU.|
1732537|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in cognitive functioning statistical analysis at Cycle 5.|
1732538|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at end of FU.|
1732539|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at Cycle 11.|
1732540|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in emotional functioning statistical analysis at Cycle 5.|
1732541|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in role functioning statistical analysis at end of FU.|
1732542|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in role functioning statistical analysis at Cycle 11.|
1732543|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in role functioning statistical analysis at Cycle 5.|
1732544|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at end of FU.|
1732545|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at Cycle 11.|
1732546|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in physical functioning statistical analysis at Cycle 5.|
1732547|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at end of FU.|
1732548|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at Cycle 11.|
1732549|NCT00532129|3189822|Superiority or Other||||||=|0|||||||t-test, 2 sided|||CFB in GHS/QoL statistical analysis at Cycle 5.|
1732550|NCT00531960|3189837|Superiority or Other||Difference in Disease Control Rates|-12.2||||0.0944|2-Sided|95.0|-27.3|2.8|||Chi-squared||The 95% CI for the difference in disease control was determined using the Hauck-Anderson method.||
1732551|NCT00531960|3189838|Superiority or Other||Difference in Response Rates|-17.28||||0.0444|2-Sided|95.0|-34.8|0.3|||Chi-squared||The 95% CI for the difference of 2 rates was determined by using the Hauck-Anderson method.||
1732552|NCT00531960|3189839|Superiority or Other||Hazard Ratio (HR)|1.24||||0.4063|2-Sided|95.0|0.75|2.05|||Log Rank||||
1732553|NCT00531960|3189841|Superiority or Other||Hazard Ratio (HR)|1.05||||0.806|2-Sided|95.0|0.7|1.59|||Log Rank||||
1732554|NCT00531934|3189875|Superiority or Other|||||||0.003|||||||Cochran-Mantel-Haenszel|||Erlotinib + doxycycline vs Erlotinib: Grade 3|
1732555|NCT00531934|3189881|Superiority or Other||Hazard Ratio (HR)|0.769||||0.153|2-Sided|95.0|0.529|1.116|||Log Rank||||
1732556|NCT00531934|3189884|Superiority or Other||Hazard Ratio (HR)|0.763||||0.143|2-Sided|95.0|0.525|1.109|||Log Rank||||
1732557|NCT00531934|3189890|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Erlotinib + doxycycline vs Erlotinib: Grade 3 intensity skin rash (folliculitis)|
1732558|NCT00531934|3189893|Superiority or Other|||||||0.175|||||||Chi-squared||||
1732559|NCT00531817|3189907|Superiority or Other||Mean Difference (Final Values)|18.85|||<|0.0001|2-Sided|95.0|12.29|25.42||The p-value was not adjusted. The primary objective was a single comparison with an a priori threshold of 0.05 for statistical significance.|Fisher Exact|||Power calculation: Assuming placebo+DMARDs response rate of 15% and tocilizumab 8 mg/kg+DMARDs response rate of 28% based on previous trials, a sample size of 570 patients (2:1 ratio, tocilizumab+DMARDs n=380 and placebo+DMARDs n=190) will provide > 90% power to detect a difference between 2 treatment arms with 5% Type I error with a 2-sided Fisher’s exact test. Null Hypothesis: The percentage of patients responding in each treatment group (tocilizumab+DMARDs vs placebo+ DMARDs) is the same.|
1732560|NCT00531752|3189914|Superiority or Other||LS Mean Difference|-3.8781|Standard Error of the Mean|1.8976||0.0473|2-Sided|80.0|-6.349|-1.407|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732561|NCT00531752|3189914|Superiority or Other||LS Mean Difference|-3.2001|Standard Error of the Mean|1.7614||0.0765|2-Sided|80.0|-5.494|-0.9063|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732562|NCT00531752|3189914|Superiority or Other||LS Mean Difference|1.0911|Standard Error of the Mean|2.4268||0.6552|2-Sided|80.0|-2.067|4.2494|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732563|NCT00531752|3189914|Superiority or Other||LS Mean Difference|-3.5341|Standard Error of the Mean|2.3172||0.1346|2-Sided|80.0|-6.551|-0.5175|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732564|NCT00531752|3189914|Superiority or Other||LS Mean Difference|-8.126|Standard Error of the Mean|2.8841||0.0068|2-Sided|80.0|-11.87|-4.382|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732565|NCT00531752|3189914|Superiority or Other||LS Mean Difference|-13.3264|Standard Error of the Mean|2.6944|<|0.0001|2-Sided|80.0|-16.83|-9.828|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732566|NCT00531752|3189915|Superiority or Other||LS Mean Difference|0.4278|Standard Error of the Mean|0.1212||0.0008|2-Sided|80.0|0.27079|0.58479|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732567|NCT00531752|3189915|Superiority or Other||LS Mean Difference|0.2195|Standard Error of the Mean|0.1146||0.0603|2-Sided|80.0|0.07101|0.36803|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732568|NCT00531752|3189915|Superiority or Other||LS Mean Difference|0.107|Standard Error of the Mean|0.09797||0.2809|2-Sided|80.0|-0.0205|0.23458|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732569|NCT00531752|3189915|Superiority or Other||LS Mean Difference|0.1362|Standard Error of the Mean|0.09408||0.1553|2-Sided|80.0|0.01366|0.25882|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732570|NCT00531752|3189915|Superiority or Other||LS Mean Difference|0.3643|Standard Error of the Mean|0.1174||0.0031|2-Sided|80.0|0.21189|0.51664|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732571|NCT00531752|3189915|Superiority or Other||LS Mean Difference|0.5103|Standard Error of the Mean|0.1103|<|0.0001|2-Sided|80.0|0.36707|0.65345|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732572|NCT00531752|3189916|Superiority or Other||LS Mean Difference|0.4184|Standard Error of the Mean|0.1681||0.0162|2-Sided|80.0|0.20006|0.63674|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732573|NCT00531752|3189916|Superiority or Other||LS Mean Difference|0.3433|Standard Error of the Mean|0.1565||0.0332|2-Sided|80.0|0.13988|0.54663|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732574|NCT00531752|3189916|Superiority or Other||LS Mean Difference|0.198|Standard Error of the Mean|0.1498||0.1929|2-Sided|80.0|0.00319|0.39272|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732575|NCT00531752|3189916|Superiority or Other||LS Mean Difference|0.1526|Standard Error of the Mean|0.1431||0.2921|2-Sided|80.0|-0.0336|0.33878|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732576|NCT00531752|3189916|Superiority or Other||LS Mean Difference|0.5285|Standard Error of the Mean|0.1847||0.0059|2-Sided|80.0|0.28911|0.76798|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732577|NCT00531752|3189916|Superiority or Other||LS Mean Difference|0.7671|Standard Error of the Mean|0.1731|<|0.0001|2-Sided|80.0|0.5426|0.99157|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732578|NCT00531752|3189917|Superiority or Other||LS Mean Difference|-0.4137|Standard Error of the Mean|0.1856||0.0306|2-Sided|80.0|-0.6549|-0.1725|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732579|NCT00531752|3189917|Superiority or Other||LS Mean Difference|-0.3451|Standard Error of the Mean|0.1738||0.0531|2-Sided|80.0|-0.5711|-0.1191|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732580|NCT00531752|3189917|Superiority or Other||LS Mean Difference|-0.1263|Standard Error of the Mean|0.1866||0.5016|2-Sided|80.0|-0.3687|0.11608|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732581|NCT00531752|3189917|Superiority or Other||LS Mean Difference|-0.4684|Standard Error of the Mean|0.1791||0.0119|2-Sided|80.0|-0.7012|-0.2356|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732582|NCT00531752|3189917|Superiority or Other||LS Mean Difference|-0.3075|Standard Error of the Mean|0.1871||0.1055|2-Sided|80.0|-0.5499|-0.065|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732583|NCT00531752|3189917|Superiority or Other||LS Mean Difference|-0.6766|Standard Error of the Mean|0.1759||0.0003|2-Sided|80.0|-0.9046|-0.4487|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732584|NCT00531752|3189918|Superiority or Other||LS Mean Difference|5.0229|Standard Error of the Mean|3.8154||0.1931|2-Sided|80.0|0.07753|9.9683|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732585|NCT00531752|3189918|Superiority or Other||LS Mean Difference|8.5752|Standard Error of the Mean|3.5848||0.0201|2-Sided|80.0|3.9265|13.224|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732586|NCT00531752|3189918|Superiority or Other||LS Mean Difference|3.7518|Standard Error of the Mean|3.0743||0.2284|2-Sided|80.0|-0.2442|7.7479|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732587|NCT00531752|3189918|Superiority or Other||LS Mean Difference|6.9558|Standard Error of the Mean|2.9408||0.0223|2-Sided|80.0|3.132|10.78|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732588|NCT00531752|3189918|Superiority or Other||LS Mean Difference|4.3455|Standard Error of the Mean|4.1817||0.3034|2-Sided|80.0|-1.08|9.7713|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732589|NCT00531752|3189918|Superiority or Other||LS Mean Difference|26.8615|Standard Error of the Mean|3.9167|<|0.0001|2-Sided|80.0|21.777|31.946|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732590|NCT00531752|3189919|Superiority or Other||LS Mean Difference|12.9251|Standard Error of the Mean|2.8913|<|0.0001|2-Sided|80.0|9.1761|16.674|||Mixed Models Analysis|||Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732591|NCT00531752|3189919|Superiority or Other||LS Mean Difference|2.8582|Standard Error of the Mean|2.6389|<|0.2837|2-Sided|80.0|-0.567|6.2835|||Mixed Models Analysis|||Week 3 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732592|NCT00531752|3189919|Superiority or Other||LS Mean Difference|67.7022|Standard Error of the Mean|17.4066|<|0.0003|2-Sided|80.0|45.114|90.29|||Mixed Models Analysis|||Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732593|NCT00531752|3189919|Superiority or Other||LS Mean Difference|5.1569|Standard Error of the Mean|16.2884|<|0.7528|2-Sided|80.0|-15.99|26.303|||Mixed Models Analysis|||Week 3 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732594|NCT00531752|3189919|Superiority or Other||LS Mean Difference|5.0362|Standard Error of the Mean|3.3182|<|0.1356|2-Sided|80.0|0.72505|9.3473|||Mixed Models Analysis|||Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732595|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-6.0062|Standard Error of the Mean|3.1094|<|0.0595|2-Sided|80.0|-10.05|-1.964|||Mixed Models Analysis|||Week 3 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732596|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-6.3429|Standard Error of the Mean|4.1977|<|0.1367|2-Sided|80.0|-11.79|-0.896|||Mixed Models Analysis|||Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732597|NCT00531752|3189919|Superiority or Other||LS Mean Difference|0.4367|Standard Error of the Mean|3.9301|<|0.9119|2-Sided|80.0|-4.665|5.5387|||Mixed Models Analysis|||Week 3 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732598|NCT00531752|3189919|Superiority or Other||LS Mean Difference|0.1016|Standard Error of the Mean|0.1136|<|0.375|2-Sided|80.0|-0.0457|0.24881|||Mixed Models Analysis|||Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732599|NCT00531752|3189919|Superiority or Other||LS Mean Difference|0.2744|Standard Error of the Mean|0.1055|<|0.012|2-Sided|80.0|0.13746|0.41127|||Mixed Models Analysis|||Week 3 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732600|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-0.1722|Standard Error of the Mean|0.2064|<|0.4083|2-Sided|80.0|-0.4403|0.09599|||Mixed Models Analysis|||Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732601|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-0.5882|Standard Error of the Mean|0.1903|<|0.0034|2-Sided|80.0|-0.8356|-0.3408|||Mixed Models Analysis|||Week 3 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732602|NCT00531752|3189919|Superiority or Other||LS Mean Difference|7.6547|Standard Error of the Mean|4.7652|<|0.1141|2-Sided|80.0|1.4717|13.838|||Mixed Models Analysis|||Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732603|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-2.5882|Standard Error of the Mean|4.3902|<|0.5583|2-Sided|80.0|-8.294|3.1175|||Mixed Models Analysis|||Week 3 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732604|NCT00531752|3189919|Superiority or Other||LS Mean Difference|3.0838|Standard Error of the Mean|3.2323|<|0.3448|2-Sided|80.0|-1.116|7.2838|||Mixed Models Analysis|||Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732605|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-2.7667|Standard Error of the Mean|2.9402|<|0.3516|2-Sided|80.0|-6.59|1.0562|||Mixed Models Analysis|||Week 3 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732606|NCT00531752|3189919|Superiority or Other||LS Mean Difference|19.9806|Standard Error of the Mean|4.1501|<|0.0001|2-Sided|80.0|14.602|25.359|||Mixed Models Analysis|||Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732607|NCT00531752|3189919|Superiority or Other||LS Mean Difference|9.5242|Standard Error of the Mean|3.7993|<|0.0152|2-Sided|80.0|4.5949|14.453|||Mixed Models Analysis|||Week 3 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732608|NCT00531752|3189919|Superiority or Other||LS Mean Difference|8.0855|Standard Error of the Mean|3.1677|<|0.0134|2-Sided|80.0|3.9787|12.192|||Mixed Models Analysis|||Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732609|NCT00531752|3189919|Superiority or Other||LS Mean Difference|6.8658|Standard Error of the Mean|3.0205|<|0.0267|2-Sided|80.0|2.9504|10.781|||Mixed Models Analysis|||Week 2 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732610|NCT00531752|3189919|Superiority or Other||LS Mean Difference|50.4054|Standard Error of the Mean|19.481|<|0.0124|2-Sided|80.0|25.134|75.677|||Mixed Models Analysis|||Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732611|NCT00531752|3189919|Superiority or Other||LS Mean Difference|25.3231|Standard Error of the Mean|18.8604|<|0.1848|2-Sided|80.0|0.86393|49.782|||Mixed Models Analysis|||Week 2 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732760|NCT00530764|3190149|Superiority or Other||Estimated treatment effect|-0.35||||0.14|2-Sided|95.0|-0.81|0.11|||ANCOVA|||As for Sativex low dose versus placebo|
1732612|NCT00531752|3189919|Superiority or Other||LS Mean Difference|2.4351|Standard Error of the Mean|3.8429|<|0.5282|2-Sided|80.0|-2.532|7.4025|||Mixed Models Analysis|||Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732613|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-0.9029|Standard Error of the Mean|3.7234|<|0.809|2-Sided|80.0|-5.716|3.9101|||Mixed Models Analysis|||Week 2 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732614|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-2.1848|Standard Error of the Mean|4.7892|<|0.6502|2-Sided|80.0|-8.403|4.0338|||Mixed Models Analysis|||Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732615|NCT00531752|3189919|Superiority or Other||LS Mean Difference|0.5433|Standard Error of the Mean|4.6662|<|0.9078|2-Sided|80.0|-5.513|6.5995|||Mixed Models Analysis|||Week 2 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732616|NCT00531752|3189919|Superiority or Other||LS Mean Difference|0.08114|Standard Error of the Mean|0.1087|<|0.4585|2-Sided|80.0|-0.0598|0.22209|||Mixed Models Analysis|||Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732617|NCT00531752|3189919|Superiority or Other||LS Mean Difference|0.2115|Standard Error of the Mean|0.1033|<|0.0455|2-Sided|80.0|0.07751|0.3455|||Mixed Models Analysis|||Week 2 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732618|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-0.1591|Standard Error of the Mean|0.1913|<|0.4096|2-Sided|80.0|-0.4075|0.08935|||Mixed Models Analysis|||Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732619|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-0.3364|Standard Error of the Mean|0.1859|<|0.0762|2-Sided|80.0|-0.5777|-0.095|||Mixed Models Analysis|||Week 2 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732620|NCT00531752|3189919|Superiority or Other||LS Mean Difference|4.859|Standard Error of the Mean|2.63|<|0.0698|2-Sided|80.0|1.4493|8.2686|||Mixed Models Analysis|||Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732621|NCT00531752|3189919|Superiority or Other||LS Mean Difference|2.4586|Standard Error of the Mean|2.5231|<|0.3339|2-Sided|80.0|-0.8124|5.7295|||Mixed Models Analysis|||Week 2 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732622|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-5.7062|Standard Error of the Mean|3.5839|<|0.1178|2-Sided|80.0|-10.36|-1.05|||Mixed Models Analysis|||Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732623|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-0.2989|Standard Error of the Mean|3.4103|<|0.9305|2-Sided|80.0|-4.729|4.1309|||Mixed Models Analysis|||Week 2 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732624|NCT00531752|3189919|Superiority or Other||LS Mean Difference|14.3485|Standard Error of the Mean|4.5692|<|0.0026|2-Sided|80.0|8.4275|20.27|||Mixed Models Analysis|||Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732625|NCT00531752|3189919|Superiority or Other||LS Mean Difference|14.1078|Standard Error of the Mean|4.3667|<|0.002|2-Sided|80.0|8.4492|19.766|||Mixed Models Analysis|||Week 2 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732626|NCT00531752|3189919|Superiority or Other||LS Mean Difference|8.4691|Standard Error of the Mean|3.3037|<|0.0129|2-Sided|80.0|4.1876|12.751|||Mixed Models Analysis|||Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732627|NCT00531752|3189919|Superiority or Other||LS Mean Difference|10.9197|Standard Error of the Mean|3.0912|<|0.0008|2-Sided|80.0|6.9105|14.929|||Mixed Models Analysis|||Week 1 (SPI II): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732628|NCT00531752|3189919|Superiority or Other||LS Mean Difference|49.1543|Standard Error of the Mean|18.7622|<|0.0112|2-Sided|80.0|24.831|73.478|||Mixed Models Analysis|||Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732629|NCT00531752|3189919|Superiority or Other||LS Mean Difference|56.631|Standard Error of the Mean|17.8056|<|0.0024|2-Sided|80.0|33.532|79.73|||Mixed Models Analysis|||Week 1 (SPI I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732630|NCT00531752|3189919|Superiority or Other||LS Mean Difference|0.7208|Standard Error of the Mean|4.1517|<|0.8627|2-Sided|80.0|-4.654|6.0952|||Mixed Models Analysis|||Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732631|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-6.4319|Standard Error of the Mean|3.9541|<|0.1088|2-Sided|80.0|-11.55|-1.311|||Mixed Models Analysis|||Week 1 (Somnolence): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732632|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-5.8688|Standard Error of the Mean|4.0842|<|0.1565|2-Sided|80.0|-11.17|-0.5693|||Mixed Models Analysis|||Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732761|NCT00530764|3190149|Superiority or Other||Estimated treatment effect|-0.73||||0.011|2-Sided|95.0|-1.3|-0.17|||ANCOVA|||The change in mean pain NRS score (worst pain) was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.|
1732633|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-3.6629|Standard Error of the Mean|3.8642|<|0.3477|2-Sided|80.0|-8.681|1.3549|||Mixed Models Analysis|||Week 1 (Sleep adequacy): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732634|NCT00531752|3189919|Superiority or Other||LS Mean Difference|0.08114|Standard Error of the Mean|0.1087|<|0.4585|2-Sided|80.0|-0.0598|0.22209|||Mixed Models Analysis|||Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732635|NCT00531752|3189919|Superiority or Other||LS Mean Difference|0.1291|Standard Error of the Mean|0.1065|<|0.2307|2-Sided|80.0|-0.0091|0.26716|||Mixed Models Analysis|||Week 1 (Optimal sleep): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732636|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-0.2301|Standard Error of the Mean|0.2303|<|0.3217|2-Sided|80.0|-0.5283|0.06822|||Mixed Models Analysis|||Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732637|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-0.6228|Standard Error of the Mean|0.2203|<|0.0063|2-Sided|80.0|-0.9082|-0.3375|||Mixed Models Analysis|||Week 1 (Sleep quantity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732638|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-0.7384|Standard Error of the Mean|3.3281|<|0.8252|2-Sided|80.0|-5.056|3.5789|||Mixed Models Analysis|||Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732639|NCT00531752|3189919|Superiority or Other||LS Mean Difference|4.5601|Standard Error of the Mean|3.1318|<|0.1517|2-Sided|80.0|0.49198|8.6281|||Mixed Models Analysis|||Week 1 (ASoB): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732640|NCT00531752|3189919|Superiority or Other||LS Mean Difference|7.1594|Standard Error of the Mean|3.8022|<|0.0644|2-Sided|80.0|2.2344|12.084|||Mixed Models Analysis|||Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732641|NCT00531752|3189919|Superiority or Other||LS Mean Difference|-3.627|Standard Error of the Mean|3.5248|<|0.3078|2-Sided|80.0|-8.196|0.94237|||Mixed Models Analysis|||Week 1 (Snoring): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732642|NCT00531752|3189919|Superiority or Other||LS Mean Difference|15.6481|Standard Error of the Mean|5.3551|<|0.0049|2-Sided|80.0|8.711|22.585|||Mixed Models Analysis|||Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732643|NCT00531752|3189919|Superiority or Other||LS Mean Difference|25.0781|Standard Error of the Mean|5.0238|<|0.0001|2-Sided|80.0|18.565|31.591|||Mixed Models Analysis|||Week 1 (Sleep disturbance): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732644|NCT00531752|3189920|Superiority or Other||LS Mean Difference|0.3623|Standard Error of the Mean|0.4028||0.372|2-Sided|80.0|-0.1597|0.88432|||Mixed Models Analysis|||Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732645|NCT00531752|3189920|Superiority or Other||LS Mean Difference|-0.1854|Standard Error of the Mean|0.3702||0.6186|2-Sided|80.0|-0.6657|0.29495|||Mixed Models Analysis|||Week 3 (Family life/home): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732646|NCT00531752|3189920|Superiority or Other||LS Mean Difference|-0.1033|Standard Error of the Mean|0.4372||0.8141|2-Sided|80.0|-0.67|0.46345|||Mixed Models Analysis|||Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732647|NCT00531752|3189920|Superiority or Other||LS Mean Difference|-0.3661|Standard Error of the Mean|0.4028||0.3675|2-Sided|80.0|-0.8887|0.1566|||Mixed Models Analysis|||Week 3 (Social life): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732648|NCT00531752|3189920|Superiority or Other||LS Mean Difference|0.4255|Standard Error of the Mean|0.3871||0.2767|2-Sided|80.0|-0.0769|0.92804|||Mixed Models Analysis|||Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732649|NCT00531752|3189920|Superiority or Other||LS Mean Difference|-0.3255|Standard Error of the Mean|0.332||0.332|2-Sided|80.0|-0.7573|0.10622|||Mixed Models Analysis|||Week 3 (Work/school): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732650|NCT00531752|3189921|Superiority or Other||LS Mean Difference|6.1138|Standard Error of the Mean|9.4361||0.5194|2-Sided|80.0|-6.108|18.336|||Mixed Models Analysis|||Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732651|NCT00531752|3189921|Superiority or Other||LS Mean Difference|0.7559|Standard Error of the Mean|8.7164||0.9312|2-Sided|80.0|-10.55|12.057|||Mixed Models Analysis|||Week 3 (Relationships): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732652|NCT00531752|3189921|Superiority or Other||LS Mean Difference|24.1011|Standard Error of the Mean|12.405||0.0566|2-Sided|80.0|8.0305|40.172|||Mixed Models Analysis|||Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732653|NCT00531752|3189921|Superiority or Other||LS Mean Difference|2.666|Standard Error of the Mean|11.5818||0.8188|2-Sided|80.0|-12.36|17.69|||Mixed Models Analysis|||Week 3 (Life outlook): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732791|NCT00530335|3190192|Superiority or Other||||||<|0.001||||||P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).|t-test, 2 sided||||
1732654|NCT00531752|3189921|Superiority or Other||LS Mean Difference|-13.1401|Standard Error of the Mean|14.4478||0.3657|2-Sided|80.0|-31.8|5.5241|||Mixed Models Analysis|||Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732655|NCT00531752|3189921|Superiority or Other||LS Mean Difference|-11.7878|Standard Error of the Mean|13.4438||0.3831|2-Sided|80.0|-29.15|5.5793|||Mixed Models Analysis|||Week 3 (Psychological health): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732656|NCT00531752|3189921|Superiority or Other||LS Mean Difference|-20.3367|Standard Error of the Mean|19.6995||0.3065|2-Sided|80.0|-45.89|5.2183|||Mixed Models Analysis|||Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732657|NCT00531752|3189921|Superiority or Other||LS Mean Difference|-11.5791|Standard Error of the Mean|18.0449||0.5241|2-Sided|80.0|-35.02|11.86|||Mixed Models Analysis|||Week 3 (Life productivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732658|NCT00531752|3189922|Superiority or Other||LS Mean Difference|-2.5178|Standard Error of the Mean|1.7732||0.1623|2-Sided|80.0|-4.823|-0.2127|||Mixed Models Analysis|||Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732659|NCT00531752|3189922|Superiority or Other||LS Mean Difference|-2.1505|Standard Error of the Mean|1.5974||0.1852|2-Sided|80.0|-4.229|-0.0719|||Mixed Models Analysis|||Week 3 (IS-I): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732660|NCT00531752|3189922|Superiority or Other||LS Mean Difference|-7.3274|Standard Error of the Mean|3.2552||0.0283|2-Sided|80.0|-11.55|-3.106|||Mixed Models Analysis|||Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732661|NCT00531752|3189922|Superiority or Other||LS Mean Difference|-5.0675|Standard Error of the Mean|2.9778||0.0949|2-Sided|80.0|-8.934|-1.201|||Mixed Models Analysis|||Week 3 (IS-B/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732662|NCT00531752|3189922|Superiority or Other||LS Mean Difference|-5.0968|Standard Error of the Mean|3.0022||0.0933|2-Sided|80.0|-8.975|-1.218|||Mixed Models Analysis|||Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732663|NCT00531752|3189922|Superiority or Other||LS Mean Difference|2.9211|Standard Error of the Mean|2.8206||0.3034|2-Sided|80.0|-0.7227|6.5648|||Mixed Models Analysis|||Week 3 (R/C): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732664|NCT00531752|3189922|Superiority or Other||LS Mean Difference|1.2007|Standard Error of the Mean|3.9647||0.7631|2-Sided|80.0|-3.941|6.3423|||Mixed Models Analysis|||Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732665|NCT00531752|3189922|Superiority or Other||LS Mean Difference|1.6389|Standard Error of the Mean|3.6119||0.6519|2-Sided|80.0|-3.05|6.3281|||Mixed Models Analysis|||Week 3 (PDF): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732666|NCT00531752|3189922|Superiority or Other||LS Mean Difference|-4.8639|Standard Error of the Mean|2.2354||0.0334|2-Sided|80.0|-7.759|-1.968|||Mixed Models Analysis|||Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732667|NCT00531752|3189922|Superiority or Other||LS Mean Difference|0.6537|Standard Error of the Mean|2.0857||0.7551|2-Sided|80.0|-2.051|3.3584|||Mixed Models Analysis|||Week 3 (General well-being): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732668|NCT00531752|3189922|Superiority or Other||LS Mean Difference|-1.4317|Standard Error of the Mean|1.4667||0.333|2-Sided|80.0|-3.333|0.46937|||Mixed Models Analysis|||Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732669|NCT00531752|3189922|Superiority or Other||LS Mean Difference|0.1702|Standard Error of the Mean|1.354||0.9005|2-Sided|80.0|-1.587|1.9274|||Mixed Models Analysis|||Week 3 (Living with ADHD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732670|NCT00531752|3189922|Superiority or Other||LS Mean Difference|0.07717|Standard Error of the Mean|0.1925||0.6901|2-Sided|80.0|-0.1726|0.32695|||Mixed Models Analysis|||Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732671|NCT00531752|3189922|Superiority or Other||LS Mean Difference|-0.2453|Standard Error of the Mean|0.1753||0.1678|2-Sided|80.0|-0.473|-0.0177|||Mixed Models Analysis|||Week 3 (More GD than BD): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732672|NCT00531752|3189922|Superiority or Other||LS Mean Difference|0.07917|Standard Error of the Mean|0.1002||0.4332|2-Sided|80.0|-0.051|0.2093|||Mixed Models Analysis|||Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732673|NCT00531752|3189922|Superiority or Other||LS Mean Difference|0.06109|Standard Error of the Mean|0.09093||0.5049|2-Sided|80.0|-0.0571|0.17926|||Mixed Models Analysis|||Week 3 (RTI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732674|NCT00531752|3189922|Superiority or Other||LS Mean Difference|0.1044|Standard Error of the Mean|0.1418||0.4642|2-Sided|80.0|-0.0793|0.28814|||Mixed Models Analysis|||Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1741650|NCT00432809|3203957|Superiority or Other|||||||0.67|||||||ANOVA||||
1732675|NCT00531752|3189922|Superiority or Other||LS Mean Difference|0.125|Standard Error of the Mean|0.1302||0.3414|2-Sided|80.0|-0.0439|0.29385|||Mixed Models Analysis|||Week 3 (GLI): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732676|NCT00531752|3189922|Superiority or Other||LS Mean Difference|0.04804|Standard Error of the Mean|0.3227||0.8822|2-Sided|80.0|-0.3703|0.4664|||Mixed Models Analysis|||Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732677|NCT00531752|3189922|Superiority or Other||LS Mean Difference|-0.09953|Standard Error of the Mean|0.3001||0.7415|2-Sided|80.0|-0.4892|0.29012|||Mixed Models Analysis|||Week 3 (CQoL): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732678|NCT00531752|3189923|Superiority or Other||LS Mean Difference|-0.02518|Standard Error of the Mean|0.6772||0.9705|2-Sided|80.0|-0.9035|0.85312|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732679|NCT00531752|3189923|Superiority or Other||LS Mean Difference|-0.4181|Standard Error of the Mean|0.6887||0.5466|2-Sided|80.0|-1.313|0.47668|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732680|NCT00531752|3189924|Superiority or Other||LS Mean Difference|-0.2078|Standard Error of the Mean|0.9165||0.8216|2-Sided|80.0|-1.399|0.98326|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732681|NCT00531752|3189924|Superiority or Other||LS Mean Difference|-1.5069|Standard Error of the Mean|0.8744||0.0913|2-Sided|80.0|-2.643|-0.3705|||Mixed Models Analysis|||Week 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732682|NCT00531752|3189925|Superiority or Other||LS Mean Difference|3.3672|Standard Error of the Mean|3.8657||0.3922|2-Sided|80.0|-1.725|8.4592|||Mixed Models Analysis|||Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732683|NCT00531752|3189925|Superiority or Other||LS Mean Difference|-0.7306|Standard Error of the Mean|2.9257||0.8056|2-Sided|80.0|-4.622|3.1613|||Mixed Models Analysis|||Day 21: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732684|NCT00531752|3189925|Superiority or Other||LS Mean Difference|3.5616|Standard Error of the Mean|3.3113||0.2945|2-Sided|80.0|-0.8226|7.9458|||Mixed Models Analysis|||Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732685|NCT00531752|3189925|Superiority or Other||LS Mean Difference|2.1151|Standard Error of the Mean|3.0732||0.4994|2-Sided|80.0|-1.961|6.1913|||Mixed Models Analysis|||Day 14: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732686|NCT00531752|3189925|Superiority or Other||LS Mean Difference|2.2644|Standard Error of the Mean|1.7026||0.1895|2-Sided|80.0|0.0533|4.4756|||Mixed Models Analysis|||Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732687|NCT00531752|3189925|Superiority or Other||LS Mean Difference|3.7114|Standard Error of the Mean|1.6168||0.0261|2-Sided|80.0|1.6105|5.8122|||Mixed Models Analysis|||Day 13: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732688|NCT00531752|3189925|Superiority or Other||LS Mean Difference|0.4377|Standard Error of the Mean|2.5148||0.8626|2-Sided|80.0|-2.83|3.7058|||Mixed Models Analysis|||Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732689|NCT00531752|3189925|Superiority or Other||LS Mean Difference|1.764|Standard Error of the Mean|2.3939||0.4652|2-Sided|80.0|-1.352|4.8801|||Mixed Models Analysis|||Day 12: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732690|NCT00531752|3189925|Superiority or Other||LS Mean Difference|2.0511|Standard Error of the Mean|2.2662||0.3697|2-Sided|80.0|-0.8912|4.9934|||Mixed Models Analysis|||Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732691|NCT00531752|3189925|Superiority or Other||LS Mean Difference|3.1804|Standard Error of the Mean|2.1934||0.1533|2-Sided|80.0|0.33169|6.0292|||Mixed Models Analysis|||Day 11: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732692|NCT00531752|3189925|Superiority or Other||LS Mean Difference|1.2105|Standard Error of the Mean|2.0376||0.5555|2-Sided|80.0|-1.44|3.8615|||Mixed Models Analysis|||Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732693|NCT00531752|3189925|Superiority or Other||LS Mean Difference|2.6424|Standard Error of the Mean|1.9753||0.1882|2-Sided|80.0|0.07015|5.2147|||Mixed Models Analysis|||Day 10: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732694|NCT00531752|3189925|Superiority or Other||LS Mean Difference|1.8149|Standard Error of the Mean|2.2467||0.4235|2-Sided|80.0|-1.108|4.7375|||Mixed Models Analysis|||Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732695|NCT00531752|3189925|Superiority or Other||LS Mean Difference|2.6876|Standard Error of the Mean|2.0533||0.1977|2-Sided|80.0|0.01391|5.3613|||Mixed Models Analysis|||Day 9: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732696|NCT00531752|3189925|Superiority or Other||LS Mean Difference|-0.4352|Standard Error of the Mean|2.2048||0.8442|2-Sided|80.0|-3.294|2.4238|||Mixed Models Analysis|||Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732697|NCT00531752|3189925|Superiority or Other||LS Mean Difference|-0.1058|Standard Error of the Mean|2.0529||0.9591|2-Sided|80.0|-2.771|2.5593|||Mixed Models Analysis|||Day 8: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732698|NCT00531752|3189925|Superiority or Other||LS Mean Difference|-1.3355|Standard Error of the Mean|2.4396||0.5863|2-Sided|80.0|-4.499|1.8284|||Mixed Models Analysis|||Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732699|NCT00531752|3189925|Superiority or Other||LS Mean Difference|-0.7149|Standard Error of the Mean|2.2086||0.7476|2-Sided|80.0|-3.584|2.1546|||Mixed Models Analysis|||Day 7: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732700|NCT00531752|3189925|Superiority or Other||LS Mean Difference|4.2785|Standard Error of the Mean|2.2424||0.0614|2-Sided|80.0|1.3709|7.186|||Mixed Models Analysis|||Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732701|NCT00531752|3189925|Superiority or Other||LS Mean Difference|1.0921|Standard Error of the Mean|2.1098||0.6067|2-Sided|80.0|-1.643|3.8273|||Mixed Models Analysis|||Day 6: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732702|NCT00531752|3189925|Superiority or Other||LS Mean Difference|5.9254|Standard Error of the Mean|2.0796||0.0059|2-Sided|80.0|3.2314|8.6193|||Mixed Models Analysis|||Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732703|NCT00531752|3189925|Superiority or Other||LS Mean Difference|1.6575|Standard Error of the Mean|1.9677||0.4032|2-Sided|80.0|-0.8944|4.2094|||Mixed Models Analysis|||Day 5: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732704|NCT00531752|3189925|Superiority or Other||LS Mean Difference|3.1136|Standard Error of the Mean|2.3365||0.1881|2-Sided|80.0|0.08338|6.1438|||Mixed Models Analysis|||Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732705|NCT00531752|3189925|Superiority or Other||LS Mean Difference|-0.6252|Standard Error of the Mean|2.2268||0.7799|2-Sided|80.0|-3.513|2.2629|||Mixed Models Analysis|||Day 4: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732706|NCT00531752|3189925|Superiority or Other||LS Mean Difference|-0.04276|Standard Error of the Mean|2.6874||0.9874|2-Sided|80.0|-3.521|3.4357|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732707|NCT00531752|3189925|Superiority or Other||LS Mean Difference|0.7203|Standard Error of the Mean|2.5085||0.775|2-Sided|80.0|-2.53|3.9704|||Mixed Models Analysis|||Day 3: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732708|NCT00531752|3189925|Superiority or Other||LS Mean Difference|5.6799|Standard Error of the Mean|2.3261||0.0176|2-Sided|80.0|2.6655|8.6943|||Mixed Models Analysis|||Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732709|NCT00531752|3189925|Superiority or Other||LS Mean Difference|4.2888|Standard Error of the Mean|2.1861||0.0547|2-Sided|80.0|1.4544|7.1232|||Mixed Models Analysis|||Day 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732710|NCT00531752|3189925|Superiority or Other||LS Mean Difference|6.9344|Standard Error of the Mean|1.7848||0.0003|2-Sided|80.0|4.6177|9.2512|||Mixed Models Analysis|||Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732711|NCT00531752|3189925|Superiority or Other||LS Mean Difference|3.5306|Standard Error of the Mean|1.6664||0.0392|2-Sided|80.0|1.3659|5.6952|||Mixed Models Analysis|||Day 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732712|NCT00531752|3189926|Superiority or Other||LS Mean Difference|0.875|Standard Error of the Mean|0.9488||0.3603|2-Sided|80.0|-0.3552|2.1051|||Mixed Models Analysis|||Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732713|NCT00531752|3189926|Superiority or Other||LS Mean Difference|0.492|Standard Error of the Mean|0.8742||0.5759|2-Sided|80.0|-0.6421|1.6261|||Mixed Models Analysis|||Week 3 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732714|NCT00531752|3189926|Superiority or Other||LS Mean Difference|0.6688|Standard Error of the Mean|1.3437||0.6204|2-Sided|80.0|-1.071|2.4086|||Mixed Models Analysis|||Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732715|NCT00531752|3189926|Superiority or Other||LS Mean Difference|0.1602|Standard Error of the Mean|1.2517||0.8986|2-Sided|80.0|-1.462|1.782|||Mixed Models Analysis|||Week 3 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732716|NCT00531752|3189926|Superiority or Other||LS Mean Difference|-0.04217|Standard Error of the Mean|0.7842||0.9573|2-Sided|80.0|-1.06|0.97559|||Mixed Models Analysis|||Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732717|NCT00531752|3189926|Superiority or Other||LS Mean Difference|1.8759|Standard Error of the Mean|0.7508||0.0156|2-Sided|80.0|0.90156|2.8502|||Mixed Models Analysis|||Week 2 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732762|NCT00530764|3190150|Superiority or Other||Estimated treatment effect|-0.36||||0.19|2-Sided|95.0|-0.89|0.18|||ANCOVA|||As for Sativex low dose versus placebo|
1732718|NCT00531752|3189926|Superiority or Other||LS Mean Difference|1.3779|Standard Error of the Mean|1.0114||0.179|2-Sided|80.0|0.06498|2.6908|||Mixed Models Analysis|||Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732719|NCT00531752|3189926|Superiority or Other||LS Mean Difference|0.3886|Standard Error of the Mean|0.9694||0.6901|2-Sided|80.0|-0.8694|1.6466|||Mixed Models Analysis|||Week 2 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732720|NCT00531752|3189926|Superiority or Other||LS Mean Difference|0.1623|Standard Error of the Mean|0.9622||0.8665|2-Sided|80.0|-1.08|1.4047|||Mixed Models Analysis|||Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732721|NCT00531752|3189926|Superiority or Other||LS Mean Difference|0.866|Standard Error of the Mean|0.9037||0.3405|2-Sided|80.0|-0.3008|2.0329|||Mixed Models Analysis|||Week 1 (Hyperactivity/Impulsivity): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732722|NCT00531752|3189926|Superiority or Other||LS Mean Difference|1.8607|Standard Error of the Mean|1.0912||0.0927|2-Sided|80.0|0.44874|3.2726|||Mixed Models Analysis|||Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732723|NCT00531752|3189926|Superiority or Other||LS Mean Difference|0.1677|Standard Error of the Mean|1.0269||0.8708|2-Sided|80.0|-1.162|1.4971|||Mixed Models Analysis|||Week 1 (Inattention): Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732724|NCT00531752|3189931|Superiority or Other||LS Mean Difference|1.3288|Standard Error of the Mean|1.524||0.3872|2-Sided|80.0|-0.649|3.3065|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732725|NCT00531752|3189931|Superiority or Other||LS Mean Difference|2.3154|Standard Error of the Mean|1.4638||0.1196|2-Sided|80.0|0.41601|4.2148|||Mixed Models Analysis|||Week 2: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732726|NCT00531752|3189931|Superiority or Other||LS Mean Difference|1.9146|Standard Error of the Mean|1.8777||0.3107|2-Sided|80.0|-0.51|4.3392|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732727|NCT00531752|3189931|Superiority or Other||LS Mean Difference|1.025|Standard Error of the Mean|1.7713||0.5643|2-Sided|80.0|-1.262|3.3121|||Mixed Models Analysis|||Week 1: Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732728|NCT00531752|3189932|Superiority or Other||LS Mean Difference|1.4176|Standard Error of the Mean|2.0343||0.4886|2-Sided|80.0|-1.218|4.0533||P-values are not adjusted for multiple comparisons.|Mixed Models Analysis||Positive value for the LS mean difference indicates the estimate favors placebo.|Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732729|NCT00531752|3189932|Superiority or Other||Least Squares (LS) Mean Difference|0.7947|Standard Error of the Mean|1.8848||0.6749|2-Sided|80.0|-1.649|3.2383||P-values are not adjusted for multiple comparisons.|Mixed Models Analysis||Positive value for the LS mean difference indicates the estimate favors placebo.|Mixed effects linear model was used with treatment, period and investigator as fixed effects; baseline as covariate and participants as random effect.|
1732730|NCT00531661|3189933|Superiority or Other||||||<|0.0001|||||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.||"Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all implanted patients was at least 90%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 90%~Alternative: (Freedom from device / system-related complications) > 90%"|
1732731|NCT00531661|3189934|Superiority or Other||||||<|0.0001|||||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from DSRC to OPC of 0.80.||"Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implanted patients was at least 80%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 80%~Alternative: (Freedom from device / system-related complications) > 80%"|
1732732|NCT00531661|3189935|Superiority or Other||||||<|0.0001|||||||Negative Binomial Regression||||
1732733|NCT00531661|3189936|Superiority or Other|||||||0.0236|||||||t-test, 2 sided||||
1732734|NCT00531661|3189937|Superiority or Other|||||||0.028|||||||Wilcoxon (Mann-Whitney)||||
1732735|NCT00531661|3189938|Superiority or Other|||||||0.0292|||||||Fisher Exact||||
1732736|NCT00531661|3189939|Superiority or Other|||||||0.0077|||||||ANCOVA||||
1732737|NCT00531661|3189940|Superiority or Other||||||<|0.0001|||||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implanted patients free from pressure sensor failure to OPC of 0.90.||"Analysis of sensor failures was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from pressure sensor failure rate for all patients implanted was at least 90%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 90%~Alternative: (Freedom from device / system-related complications) > 90%"|
1732738|NCT00531661|3189941|Superiority or Other||||||<|0.0001|||||||exact test of binomial proportions|P-value from exact test of binomial proportions compared proportion of all implantation cases free from DSRC to OPC of 0.80.||"Analysis of DSRC was based on the following pre-specified objective performance criteria: the lower limit of the two-sided 95.2% confidence interval on the freedom from DSRC rate for all implantation cases was at least 80%. The statistical hypotheses were:~Null: (Freedom from device / system-related complications) ≤ 80%~Alternative: (Freedom from device / system-related complications) > 80%"|
1732740|NCT00531518|3189943|Superiority or Other|||||||0.0034||||||The final analysis included adjstment for site and baseline sum psychotic symptom score.|Mixed Models Analysis|||The analysis used regression discontinuity methods, in which the baseline sum scores were adjusted and centered to an equalize control and experimental conditions.|
1732741|NCT00531479|3189944|Superiority or Other||Hazard Ratio (HR)|0.687||||0.164|2-Sided|95.0|0.4|1.16|||Cox proportional hazards model||95% confidence interval based on Greenwood’s formula.|Analysis based on Cox proportional hazards model. Participants who died beyond day 84 were censored.|
1732742|NCT00531479|3189945|Superiority or Other||Hazard Ratio (HR)|0.696||||0.083|2-Sided|95.0|0.46|1.04|||Cox proportional hazards model|||Hazard Ratio: hazard of death in the Voriconazole/Anidulafungin arm relative to the Voriconazole/Placebo arm, adjusted for host factor status and site of infection. Participants who died beyond Day 84 were censored.|
1732743|NCT00531479|3189946|Superiority or Other||Mean Difference (Final Values)|-6.24||||0.1029|2-Sided|95.0|-15.9|3.42||P-Value based on a one-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence interval based on Greenwood’s formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.|
1732744|NCT00531479|3189947|Superiority or Other||Mean Difference (Final Values)|-10.18||||0.0383|2-Sided|95.0|-21.44|1.09||P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence intervalbased on using Greenwood’s formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.|
1732745|NCT00531479|3189948|Superiority or Other||Mean Difference (Final Values)|-2.6||||0.2611|2-Sided|95.0|-10.77|5.56||P-Value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||95% confidence interval based on using Greenwood’s formula for the variance of the Kaplan Meier estimator.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.|
1732746|NCT00531479|3189949|Superiority or Other||Mean Difference (Final Values)|-10.23|||||2-Sided|95.0|-21.6|1.15|||||95% confidence interval based on the difference in success rates using the normal approximation to the binoial distribution.|Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables: site of infection and host factors.|
1732747|NCT00531479|3189950|Superiority or Other||Mean Difference (Final Values)|-8.74||||0.0434|2-Sided|95.0|-18.99|1.51||P-value based on a 1-sided test and tested against a 1-sided alpha of 0.025 to determine statistical significance.|Z test for difference in proportions||The 95% CI was based on using Greenwood’s formula for the variance of the KM estimator.|All-cause mortality calculated using the Kaplan-Meier (KM) product limit estimator on Day 42 (Week 6) within each stratum and weighted by the harmonic mean of the sample sizes in the strata. Treatment difference (stratified) based on a weighted difference in proportions. Stratification variables were site of infection and host factors.|
1732748|NCT00531427|3189953|Superiority or Other||Mean Difference (Final Values)|-4.46||||0.0034|2-Sided|95.0|-7.44|-1.48||To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.|Mixed Models Analysis|||Weeks 4, 8, 12 analysis The sleep disturbance subscale was analyzed using the mixed effect linear model with fixed effects for treatment (BTDS or placebo) and time (weeks 1, 2, 4, 8, 12) as categorical, screening mean and prerandomization mean value as covariates, and subject as a random effect.|
1732749|NCT00531427|3189954|Superiority or Other||Mean Difference (Final Values)|-0.037||||0.7098|2-Sided|95.0|-0.233|0.159||To control multiplicity and family-wise error rate, a gate-keeping strategy (stepwise approach) was used to evaluate the statistical significance of the secondary variables. If the primary is negative, the secondary P values are descriptive only.|ANCOVA|with treatment as a factor and screening and pre-randomization mean pain as covariates.||Categorical analysis P value is based on a Fisher's exact test. Mean daily number of tablets for subjects who took <=1 dose of supplemental analgesia|
1732750|NCT00531427|3189955|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.0853|2-Sided|95.0|-0.8|0.05|||Mixed Models Analysis|Statistics are based on a mixed effect general linear model||"[Week 12 analysis] The null hypothesis was “no group differences.” The alternative hypothesis was that BTDS arm was superior to the placebo arm.~Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)."|
1732751|NCT00530920|3190043|Superiority or Other||Median Difference (Final Values)|-1.47||||0.998|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline >1.2 log10 copies/mL within each group|
1732752|NCT00530920|3190043|Superiority or Other||Median Difference (Final Values)|-1.55||||1|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline >1.2 log10 copies/mL within each group|
1732753|NCT00530920|3190043|Superiority or Other||Median Difference (Final Values)|-1.43||||0.997|||||||Wilcoxon (Mann-Whitney)|||NULL HYPOTHESIS (H0): Median viral load reduction from baseline >1.2 log10 copies/mL within each group|
1732754|NCT00530842|3190111|Superiority or Other||Median Difference (Final Values)|3.0||||0.3407|2-Sided|95.0|-9.5|27.5|||Wilcoxon signed−rank test||The confidence interval was determined by Hodges−Lehmann method.||
1732755|NCT00530842|3190112|Superiority or Other||Mean Difference (Final Values)|-0.087|Standard Error of the Mean|0.044||0.0482|2-Sided|95.0|-0.174|-0.001|||ANOVA|ANOVA with fixed terms for sequence, treatment, and period and random term for subject within sequence.|||
1732756|NCT00530764|3190148|Superiority or Other||Estimated Treatment Effect|-0.33||||0.26|2-Sided|95.0|-0.9|0.24|||ANCOVA|||As for Sativex low dose versus placebo.|
1732757|NCT00530764|3190148|Superiority or Other||Estimated Treatment Effect|-0.08||||0.78|2-Sided|95.0|-0.65|0.49|||ANCOVA|||As for Sativex low dose versus placebo|
1732758|NCT00530764|3190148|Superiority or Other||Estimated Treatment Effect|-0.88||||0.003|2-Sided|95.0|-1.45|-0.31|||ANCOVA|||The change in mean sleep disturbance NRS score was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.|
1732759|NCT00530764|3190149|Superiority or Other||Estimated Treatment Effect|-0.24||||0.4|2-Sided|95.0|-0.81|0.32|||ANCOVA|||As for Sativex low dose versus placebo|
1732763|NCT00530764|3190150|Superiority or Other||Estimated treatment effect|-0.09||||0.75|2-Sided|95.0|-0.62|0.44|||ANCOVA|||As for Sativex low dose versus placebo|
1732764|NCT00530764|3190150|Superiority or Other||Estimated treatment effect|-0.75||||0.006|2-Sided|95.0|-1.28|-0.22|||ANCOVA|||The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors.|
1732765|NCT00530764|3190151|Superiority or Other||Median Difference (Final Values)|-8.75||||0.039|2-Sided|95.0|-17.14|0.0|||Wilcoxin rank sum test|||As for Sativex low dose versus placebo|
1732766|NCT00530764|3190151|Superiority or Other||Median Difference (Final Values)|-1.97||||0.67|2-Sided|95.0|-11.04|7.14|||Wilcoxin rank sum test|||As for Sativex low dose versus placebo|
1732767|NCT00530764|3190151|Superiority or Other||Median Difference (Final Values)|-12.5||||0.0077|2-Sided|95.0|-21.35|-3.33|||Wilcoxon rank sum tests|||Each of the active treatment groups were compared with placebo using pairwise Wilcoxon rank-sum tests. The Hodges-Lehmann estimates and 95% CI for the median differences were also presented.|
1732768|NCT00530764|3190152|Superiority or Other||Odds Ratio (OR)|1.19||||0.61|2-Sided|95.0|0.62|2.28|||Regression, Logistic|||As for Sativex Low dose versus placebo|
1732769|NCT00530764|3190152|Superiority or Other||Odds Ratio (OR)|0.9||||0.62|2-Sided|95.0|0.46|1.76|||Regression, Logistic|||As for Sativex Low dose versus placebo|
1732770|NCT00530764|3190152|Superiority or Other||Odds Ratio (OR)|1.37||||0.33|2-Sided|95.0|0.72|2.6|||Regression, Logistic|||The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each of the Sativex treatment groups and placebo. The estimated response rates, odds ratios, 95% CIs for the odds ratios and p-values were presented.|
1732771|NCT00530439|3190169|Superiority or Other|||||||0.014|||||||Wilcoxon (Mann-Whitney)||||
1732772|NCT00530348|3190176|Superiority or Other|||||||0.308|||||||Ranked ANCOVA|||Ranked ANCOVA models with covariate adjustment for geographic region and baseline T2 lesion volume was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.|
1732773|NCT00530348|3190177|Superiority or Other|||||||0.0115|||||||Wei-Lachin|||Change at Year 2: analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by MSFC. Each endpoint could only be formally tested if prior endpoint was significant.|
1732774|NCT00530348|3190178|Superiority or Other|||||||0.4188|||||||Wei-Lachin|||The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.|
1732775|NCT00530348|3190179|Superiority or Other||Hazard Ratio (HR)|0.45|||<|0.0001|2-Sided|95.0|0.33|0.61|||Cox Proportional Hazards Regression|||Cox PH regression model with robust variance estimation, covariate adjustment for geographic region, was used. Secondary endpoints were analyzed sequentially as: Proportion of participants relapse free at Year 2, Change from baseline in EDSS, Percent change from Baseline in magnetic resonance imaging-T2 hyperintense lesion volume at Year 2, Acquisition of disability measured by multiple sclerosis functional composite. Each endpoint could only be formally tested if prior endpoint was significant.|
1732776|NCT00530348|3190180|Superiority or Other||Rate ratio|0.45|||<|0.0001|2-Sided|95.0|0.32|0.63||Hochberg method was used to adjust for the two co-primary outcomes.|Proportional means regression|||Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.|
1732777|NCT00530348|3190181|Superiority or Other||Hazard Ratio (HR)|0.7||||0.2173|2-Sided|95.0|0.4|1.23||Hochberg method was used to adjust for the two co-primary outcomes.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariates was used.|
1732778|NCT00530335|3190186|Superiority or Other|||||||0.003||||||P-value for comparing differences in Color-Word Test number of correct responses (endpoint - baseline).|t-test, 2 sided||||
1732779|NCT00530335|3190186|Superiority or Other||||||<|0.001||||||P-value for comparing differences in Color Test number of correct responses (endpoint - baseline).|t-test, 2 sided||||
1732780|NCT00530335|3190186|Superiority or Other||||||<|0.005||||||P-value for comparing differences in Word Test number of correct responses (endpoint - baseline).|t-test, 2 sided||||
1732781|NCT00530335|3190188|Superiority or Other|||||||0.886|||||||t-test, 2 sided||||
1732782|NCT00530335|3190189|Superiority or Other|||||||0.749|||||||t-test, 2 sided||||
1732783|NCT00530335|3190190|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1732784|NCT00530335|3190191|Superiority or Other||||||<|0.001||||||P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).|t-test, 2 sided||||
1732785|NCT00530335|3190191|Superiority or Other||||||<|0.001||||||P-value comparing difference in Hyperactive/Impulsive Subscale scores (endpoint - baseline).|t-test, 2 sided||||
1732786|NCT00530335|3190191|Superiority or Other||||||<|0.001||||||P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).|t-test, 2 sided||||
1732787|NCT00530335|3190191|Superiority or Other||||||<|0.001||||||P-value comparing difference in Total ADHD Symptoms Score (endpoint - baseline).|t-test, 2 sided||||
1732788|NCT00530335|3190192|Superiority or Other||||||<|0.001||||||P-value comparing difference in ADHD Index Subscale scores (endpoint - baseline).|t-test, 2 sided||||
1732789|NCT00530335|3190192|Superiority or Other||||||<|0.001||||||P-value comparing difference in Hyperactivity/Impulsive Subscale scores (endpoint - baseline).|t-test, 2 sided||||
1732790|NCT00530335|3190192|Superiority or Other||||||<|0.001||||||P-value comparing difference in Inattentive Subscale scores (endpoint - baseline).|t-test, 2 sided||||
1732792|NCT00530270|3190194|Superiority or Other|||||||0.77||||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.|
1732793|NCT00530270|3190195|Superiority or Other|||||||0.876||||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.|
1732794|NCT00530270|3190196|Superiority or Other|||||||0.02||||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|Different error variance estimates were allowed for the two treatment groups.||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.|
1732795|NCT00530270|3190197|Superiority or Other|||||||0.801||||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.|
1732796|NCT00530270|3190198|Superiority or Other|||||||0.127||||||A two-sided alpha of 0.05 was used. No multiple comparison adjustments were made.|Mixed Models Analysis|||The null hypothesis of no difference in the log duration of signs and symptoms or hospitalization between the two treatment groups was tested using an F test from a generalized mixed model with fixed effects for treatment group, age group and ACS severity. Please note that the study was stopped prematurely so only 11 of the 112 originally planned were included in the analysis.|
1732797|NCT00530257|3190199|Superiority or Other||||||<|0.01||||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk|
1732798|NCT00530257|3190200|Superiority or Other||||||<|0.01||||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk|
1732799|NCT00530257|3190201|Superiority or Other||||||<|0.01||||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk|
1732800|NCT00530257|3190202|Superiority or Other||||||<|0.01||||||Same as described for TEA-Ch: Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk|
1732801|NCT00530257|3190203|Superiority or Other||||||<|0.01||||||The p value adjusts for multiple comparisons|Wilcoxon (Mann-Whitney)||||
1732802|NCT00530257|3190204|Superiority or Other||||||<|0.01||||||Same as described for TEA-Ch: Walk, Don't Walk.|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch: Walk, Don't Walk|
1732803|NCT00530257|3190206|Superiority or Other||||||<|0.05||||||We did not correct for multiple comparisons|t-test, 2 sided|We used a paired t-test||A paired t-test was used to compare the medication versus placebo.|
1732804|NCT00530257|3190208|Superiority or Other||||||<|0.05||||||This p value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.|
1732805|NCT00530257|3190209|Superiority or Other||||||<|0.01||||||Same as described for TEA-Ch Walk, Don't Walk|Wilcoxon (Mann-Whitney)|||Same as described for TEA-Ch Walk, Don't Walk|
1732806|NCT00530257|3190210|Superiority or Other||||||<|0.01||||||We used a Bonferroni correct to adjust for up to 5 measures across domains and use a p-value of <=0.01. With a sample of 30 subjects the analytic model was able to detect a difference of large effect size (Cohen’s d= >0.655)|Wilcoxon (Mann-Whitney)|||We evaluated the data for cross over effects. No statistical significant sequence effect were seen for our endpoints and hence we combined the data from both periods of the crossover design There was evidence against the assumption of normality for performance on some of the measures of attention. Thus we used the non-parametric Wilcoxon Signed Ranks Test to compare performance on OROS-methylphenidate versus placebo.|
1732807|NCT00529958|3190241|Equivalence|The sample size calculation was based on 88 ACL-deficient patients with surgical intervention and an ACL-QOL score of 74.5 (SD=20.1) at a mean 39-month follow-up, a minimal clinically important difference of 10 points, power=0.80 and p=0.05.|||||<|0.05||||||A Bonferroni adjustment for multiple comparisons was used in the sample size calculation, resulting in 90 patients per group. With a 20% lost-to-follow-up rate, the final sample size was 108 patients per group for a total of 324 patients.|Mixed Models Analysis|||"All patients were analyzed on an intention-to-treat basis using a 5% significance level for all analyses. The ACL-QOL scores for each study group were analyzed using adjusted Bonferroni comparisons and repeated-measures analyses, using a mixed-model analysis of variance for treatment group over time of assessment."|
1732808|NCT00529802|3190242|Superiority or Other||Slope|0.0028|Standard Error of the Mean|0.00109||0.013|2-Sided|95.0|0.00063|0.004997|||Regression, Linear|Tumor size change (outcome variable) was log-transformed to satisfy the normality assumption.|Outcome was log(tumor size at 8 weeks/tumor size at baseline), and the predictor was the early change in aveSUVmax [(aveSUVmax at 2 weeks - aveSUVmax at baseline)/aveSUVmax at baseline] x 100%.|The relationship between early changes in SUV uptake (from baseline to 2 weeks) and tumor size changes (from baseline to 8 weeks) were examined using linear regression models. Tumor size change was log-transformed to satisfy the normality assumption.|
1733108|NCT00528372|3190737|Superiority or Other||Difference from placebo|-1.55|Standard Error of the Mean|0.7394|||2-Sided|95.0|-3.33|-0.42|||||||
1732809|NCT00529802|3190243|Superiority or Other||Mean Difference (Net)|1.9||||0.69|2-Sided|95.0|-9.3|13.23|||t-test, 2 sided|Relative changes in tumor size were log-transformed to satisfy the normality assumption for the t-test.|Mean difference is the difference between Low and High SUV uptake groups in tumor size percent (%) change from baseline, and is reported on the raw scale. Tumor size changes were log-transformed for the t-test.|Relative changes in tumor size were log-transformed to satisfy the normality assumption.|
1732810|NCT00529568|3190306|Superiority or Other||Percentage difference in SVR|6.0||||0.0202|2-Sided|95.0|1.2|10.9||Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata|Cochran-Mantel-Haenszel||The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.||
1732811|NCT00529542|3190308|Superiority or Other||Mean Difference (Net)|0.2||||0.63|2-Sided|95.0|-0.6|1.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732812|NCT00529542|3190309|Superiority or Other||Mean Difference (Net)|3.5||||0.48|2-Sided|95.0|-6.8|13.7|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732813|NCT00529542|3190310|Superiority or Other||Mean Difference (Net)|-7.8||||0.05|2-Sided|95.0|-15.8|0.1|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732814|NCT00529542|3190311|Superiority or Other||Mean Difference (Net)|-5.9||||0.27|2-Sided|95.0|-16.9|5.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732815|NCT00529542|3190312|Superiority or Other||Mean Difference (Net)|-2.4||||0.21|2-Sided|95.0|-6.4|1.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732816|NCT00529542|3190313|Superiority or Other||Mean Difference (Net)|-364.3||||0.02|2-Sided|95.0|-655.3|-73.2|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732817|NCT00529542|3190314|Superiority or Other||Mean Difference (Net)|-1.1|||<|0.001|2-Sided|95.0|-1.6|-0.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732818|NCT00529542|3190315|Superiority or Other||Mean Difference (Net)|1.8||||0.88|2-Sided|95.0|-24.1|27.8|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732819|NCT00529542|3190316|Superiority or Other||Mean Difference (Net)|3385.0||||0.07|2-Sided|95.0|-287.0|7056.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732820|NCT00529542|3190317|Superiority or Other||Mean Difference (Net)|586.0||||0.61|2-Sided|95.0|-1811.0|2983.0|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732821|NCT00529542|3190318|Superiority or Other||Mean Difference (Net)|2.5||||0.33|2-Sided|95.0|-2.8|7.9|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732822|NCT00529542|3190319|Superiority or Other||Mean Difference (Net)|-3.3||||0.45|2-Sided|95.0|-12.4|5.8|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732823|NCT00529542|3190320|Superiority or Other||Mean Difference (Net)|-82.2|||<|0.001|2-Sided|95.0|-126.2|-38.1|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732824|NCT00529542|3190321|Superiority or Other||Mean Difference (Net)|3.4||||0.26|2-Sided|95.0|-2.7|9.5|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732825|NCT00529542|3190322|Superiority or Other||Mean Difference (Net)|-57.6|||<|0.001|2-Sided|95.0|-79.3|-35.9|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732826|NCT00529542|3190323|Superiority or Other||Mean Difference (Net)|-70.8|||<|0.001|2-Sided|95.0|-95.2|-46.4|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732827|NCT00529542|3190324|Superiority or Other||Mean Difference (Net)|0.7||||0.39|2-Sided|95.0|-0.9|2.3|||Linear mixed-effects models|||"What is being compared for this analysis is the change from baseline for Atorvastatin to the change from baseline for Placebo."|
1732828|NCT00529542|3190325|Superiority or Other||Mean Difference (Net)|-2.0||||0.58|2-Sided|95.0|-9.3|5.3||All hypotheses tests were two-sided.|Linear mixed-effects models|Linear mixed-effects models were fit to continuous outcomes to assess the change from baseline to 6 weeks between groups.|This analysis revealed that the required sample size was 235 subjects per group for 80% power to detect an absolute 2% increase in FMD with Atorvastatin vs. Placebo. We stopped the trial because we had insufficient funds for the required sample size.|This study was initiated as a pilot study with the goal of enrolling 19 women in each group, which we hypothesized would provide 80% power to detect an absolute difference in the change in FMD from baseline between the two groups (Atorvastatin vs. Placebo) of 3.75%, assuming a common standard deviation (SD) of 4%, using a two-sided, two-sample t-test with α=0.05. Recruitment was slow due to strict inclusion/ exclusion criteria so we analyzed our data after the first 20 women completed the study.|
1732829|NCT00529451|3190365|Non-Inferiority or Equivalence|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-1.48|||||2-Sided|95.0|-2.67|-0.28|||||||
1732830|NCT00529451|3190366|Non-Inferiority or Equivalence|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-0.86|||||2-Sided|95.0|-2.06|0.34|||||||
1733109|NCT00528372|3190737|Superiority or Other||Mean Difference (Final Values)|-2.23|Standard Error of the Mean|0.6404|||||||||||||
1732831|NCT00529451|3190367|Non-Inferiority or Equivalence|Non-inferiority margin of 2.25 mm Hg|Mean Difference (Final Values)|-2.44|||||2-Sided|95.0|-3.63|-1.25|||||||
1732832|NCT00529399|3190371|Superiority or Other (legacy)|||||||0.51|||||||ANCOVA|||The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the “AUC mean” and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.|
1732833|NCT00529399|3190371|Superiority or Other (legacy)|||||||0.98|||||||ANCOVA|||The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the “AUC mean” and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.|
1732834|NCT00529373|3190373|Other|Miettinen & Nurminen|Difference in rates|0.03|||||2-Sided|95.0|0.02|0.06|||||||
1732835|NCT00529373|3190374|Other|Miettinen & Nurminen|Difference in rates|0.06|||||2-Sided|95.0|0.03|0.11|||||||
1732836|NCT00529373|3190375|Other|Miettinen & Nurminen|Difference in rates|0.02|||||2-Sided|95.0|0.01|0.05|||||||
1732837|NCT00529373|3190376|Other|Miettinen & Nurminen|Difference in rates|0.04|||||2-Sided|95.0|-0.01|0.09|||||||
1732838|NCT00529373|3190377|Other||Hazard Ratio (HR)|1.17||||0.178|2-Sided|95.0|0.93|1.46|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732839|NCT00529373|3190378|Other||Hazard Ratio (HR)|1.14||||0.159|2-Sided|95.0|0.99|1.31|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732840|NCT00529373|3190379|Other||Hazard Ratio (HR)|1.61||||0.114|2-Sided|95.0|0.89|2.9|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732841|NCT00529373|3190380|Other||Hazard Ratio (HR)|1.22||||0.059|2-Sided|95.0|0.99|1.5|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732842|NCT00529373|3190381|Other||Hazard Ratio (HR)|1.37||||0.005|2-Sided|95.0|1.1|1.71|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732843|NCT00529373|3190382|Other||Hazard Ratio (HR)|0.94||||0.798|2-Sided|95.0|0.7|1.26|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732844|NCT00529373|3190383|Other||Hazard Ratio (HR)|1.23||||0.198|2-Sided|95.0|0.9|1.68|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732845|NCT00529373|3190384|Other||Hazard Ratio (HR)|1.05||||0.341|2-Sided|95.0|0.95|1.17|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732846|NCT00529373|3190385|Other||Hazard Ratio (HR)|1.17||||0.029|2-Sided|95.0|1.02|1.36|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732847|NCT00529373|3190386|Other||Hazard Ratio (HR)|0.8||||0.638|2-Sided|95.0|0.32|2.03|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732848|NCT00529373|3190387|Other||Hazard Ratio (HR)|1.13||||0.246|2-Sided|95.0|0.92|1.4|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732849|NCT00529373|3190388|Other||Hazard Ratio (HR)|0.79||||0.366|2-Sided|95.0|0.47|1.33|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732850|NCT00529373|3190389|Other||Difference in Least Squares Means|14.94|||<|0.001|2-Sided|95.0|11.29|18.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732851|NCT00529373|3190390|Other||Difference in Least Squares Means|9.98|||<|0.001|2-Sided|95.0|6.91|13.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732852|NCT00529373|3190391|Other||Difference in Least Squares Means|10.41|||<|0.001|2-Sided|95.0|8.05|12.78|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732853|NCT00529373|3190392|Other||Difference in Least Squares Means|11.08|||<|0.001|2-Sided|95.0|8.41|13.74|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732854|NCT00529373|3190393|Other||Difference in Least Squares Means|8.53|||<|0.001|2-Sided|95.0|5.79|11.28|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732855|NCT00529373|3190394|Other||Difference in Least Squares Means|-64.43|||<|0.001|2-Sided|95.0|-87.8|-41.07|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732856|NCT00529373|3190395|Other||Difference in Least Squares Means|-25.02|||<|0.001|2-Sided|95.0|-35.92|-14.12|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732857|NCT00529373|3190396|Other||Difference in Least Squares Means|1.67||||0.016|2-Sided|95.0|0.32|3.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732858|NCT00529373|3190397|Other||Difference in Least Squares Means|-26.7||||0.001|2-Sided|95.0|-42.56|-10.83|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732859|NCT00529373|3190398|Other||Difference in Least Squares Means|-62.25|||<|0.001|2-Sided|95.0|-79.99|-44.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732860|NCT00529373|3190399|Other||Difference in Least Squares Means|5.65|||<|0.001|2-Sided|95.0|3.79|7.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732861|NCT00529373|3190400|Other||Difference in Least Squares Means|3.63|||<|0.001|2-Sided|95.0|2.35|4.9|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732862|NCT00529373|3190401|Other||Difference in Least Squares Means|2.79||||0.005|2-Sided|95.0|0.86|4.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732863|NCT00529373|3190402|Other||Difference in Least Squares Means|5.55|||<|0.001|2-Sided|95.0|4.06|7.05|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732864|NCT00529373|3190403|Other||Difference in Least Squares Means|2.76|||<|0.001|2-Sided|95.0|1.43|4.1|||Longitudinal model|||Odanacatib 50 mg OW - Placebo|
1732865|NCT00529373|3190412|Other||Difference in Least Squares Means|10.87|||<|0.001|2-Sided|95.0|10.55|11.19|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732866|NCT00529373|3190412|Other||Difference in Least Squares Means|9.34|||<|0.001|2-Sided|95.0|9.08|9.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732867|NCT00529373|3190412|Other||Difference in Least Squares Means|7.7|||<|0.001|2-Sided|95.0|7.48|7.91|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732868|NCT00529373|3190412|Other||Difference in Least Squares Means|5.93|||<|0.001|2-Sided|95.0|5.75|6.11|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732869|NCT00529373|3190412|Other||Difference in Least Squares Means|4.01|||<|0.001|2-Sided|95.0|3.87|4.15|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732870|NCT00529373|3190412|Other||Difference in Least Squares Means|2.9|||<|0.001|2-Sided|95.0|2.4|3.39|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732871|NCT00529373|3190413|Other||Difference in Least Squares Means|14.56|||<|0.001|2-Sided|95.0|14.11|15.01|||Longitudinal model|Includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size)||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732872|NCT00529373|3190413|Other||Difference in Least Squares Means|12.14|||<|0.001|2-Sided|95.0|11.76|12.51|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732873|NCT00529373|3190413|Other||Difference in Least Squares Means|9.25|||<|0.001|2-Sided|95.0|8.95|9.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732874|NCT00529373|3190413|Other||Difference in Least Squares Means|6.41|||<|0.001|2-Sided|95.0|6.16|6.65|||Longitudinal model|Includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size)||Odanacatib 50 mg OW - Placebo at Month 24|
1732875|NCT00529373|3190413|Other||Difference in Least Squares Means|3.5|||<|0.001|2-Sided|95.0|3.31|3.7|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732876|NCT00529373|3190413|Other||Difference in Least Squares Means|1.74|||<|0.001|2-Sided|95.0|1.06|2.42|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732877|NCT00529373|3190414|Other||Difference in Least Squares Means|10.29|||<|0.001|2-Sided|95.0|9.99|10.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732878|NCT00529373|3190414|Other||Difference in Least Squares Means|8.48|||<|0.001|2-Sided|95.0|8.24|8.73|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732879|NCT00529373|3190414|Other||Difference in Least Squares Means|6.46|||<|0.001|2-Sided|95.0|6.26|6.65|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732880|NCT00529373|3190414|Other||Difference in Least Squares Means|4.47|||<|0.001|2-Sided|95.0|4.31|4.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732881|NCT00529373|3190414|Other||Difference in Least Squares Means|2.5|||<|0.001|2-Sided|95.0|2.38|2.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732882|NCT00529373|3190414|Other||Difference in Least Squares Means|1.34|||<|0.001|2-Sided|95.0|0.94|1.74|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732883|NCT00529373|3190415|Other||Hazard Ratio (HR)|0.67|||<|0.001|2-Sided|95.0|0.6|0.75|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.|
1732884|NCT00529373|3190416|Other||Hazard Ratio (HR)|0.33|||<|0.001|2-Sided|95.0|0.24|0.45|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. the Cox proportional hazards model included terms for treatment, stratum and geographic region.|
1733037|NCT00529087|3190518|Superiority or Other (legacy)||||||<|0.001|||||||t-test, 2 sided|||The statistical analysis for all time points (1, 2, 3 and 6 hours) is only shown once as the p value is the same for all time points.|
1732885|NCT00529373|3190417|Other||Difference in Least Squares Means|2.33||||0.001|2-Sided|95.0|1.54|3.11|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732886|NCT00529373|3190417|Other||Difference in Least Squares Means|2.18|||<|0.001|2-Sided|95.0|1.4|2.96|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732887|NCT00529373|3190417|Other||Difference in Least Squares Means|1.96|||<|0.001|2-Sided|95.0|1.42|2.5|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732888|NCT00529373|3190417|Other||Difference in Least Squares Means|1.36|||<|0.001|2-Sided|95.0|0.87|1.85|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732889|NCT00529373|3190417|Other||Difference in Least Squares Means|1.1|||<|0.001|2-Sided|95.0|0.66|1.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732890|NCT00529373|3190418|Other||Difference in Least Squares Means|10.05|||<|0.001|2-Sided|95.0|9.72|10.38|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732891|NCT00529373|3190418|Other||Difference in Least Squares Means|8.29|||<|0.001|2-Sided|95.0|8.02|8.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732892|NCT00529373|3190418|Other||Difference in Least Squares Means|6.5|||<|0.001|2-Sided|95.0|6.28|6.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732893|NCT00529373|3190418|Other||Difference in Least Squares Means|4.39|||<|0.001|2-Sided|95.0|4.2|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732894|NCT00529373|3190418|Other||Difference in Least Squares Means|2.21|||<|0.001|2-Sided|95.0|2.05|2.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732895|NCT00529373|3190418|Other||Difference in Least Squares Means|1.47|||<|0.001|2-Sided|95.0|0.92|2.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732896|NCT00529373|3190419|Other||Hazard Ratio (HR)|1.91||||0.081|2-Sided|95.0|0.93|3.97|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732897|NCT00529373|3190420|Other||Hazard Ratio (HR)|1.32||||0.034|2-Sided|95.0|1.02|1.7|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732898|NCT00529373|3190421|Other||Hazard Ratio (HR)|0.86||||0.794|2-Sided|95.0|0.29|2.57|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732899|NCT00529373|3190422|Other||Hazard Ratio (HR)|0.82||||0.256|2-Sided|95.0|0.58|1.15|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732900|NCT00529373|3190423|Other||Hazard Ratio (HR)|1.16||||0.277|2-Sided|95.0|0.89|1.52|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732901|NCT00529373|3190424|Other||Hazard Ratio (HR)|1.12||||0.127|2-Sided|95.0|0.97|1.29|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732902|NCT00529373|3190425|Other||Hazard Ratio (HR)|1.25||||0.074|2-Sided|95.0|0.98|1.6|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732903|NCT00529373|3190426|Other||Hazard Ratio (HR)|1.1||||0.606|2-Sided|95.0|0.76|1.59|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732904|NCT00529373|3190427|Other||Hazard Ratio (HR)|1.06||||0.857|2-Sided|95.0|0.59|1.89|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732905|NCT00529373|3190428|Other||Hazard Ratio (HR)|1.12||||0.127|2-Sided|95.0|0.97|1.29|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732906|NCT00529373|3190429|Other||Hazard Ratio (HR)|1.18||||0.235|2-Sided|95.0|0.9|1.55|||Regression, Cox|No adjustments for multiplicity were applied; all p-values reported were unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1732907|NCT00529373|3190430|Other||Hazard Ratio (HR)|1.12||||0.182|2-Sided|95.0|0.95|1.34|||Regression, Cox|No adjustments for multiplicity were applied; p-value is unadjusted and therefore considered nominal.||Odanacatib 50 mg OW - Placebo|
1733038|NCT00529087|3190518|Superiority or Other (legacy)||||||<|0.001|||||||t-test, 2 sided|||The statistical analysis for all time points (1, 2, 3 and 6 hours) is only shown once as the p value is the same for all time points.|
1732908|NCT00529373|3190431|Other||Mean Difference (Final Values)|-3.34||||0.61|2-Sided|95.0|-16.12|9.45|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).|
1732909|NCT00529373|3190431|Other||Mean Difference (Final Values)|-12.11|||<|0.001|2-Sided|95.0|-18.03|-6.19|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).|
1732910|NCT00529373|3190431|Other||Mean Difference (Final Values)|-16.26|||<|0.001|2-Sided|95.0|-21.41|-11.12|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).|
1732911|NCT00529373|3190431|Other||Mean Difference (Final Values)|-25.94|||<|0.001|2-Sided|95.0|-30.54|-21.34|||Longitudinal|||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).|
1732912|NCT00529373|3190431|Other||Mean Difference (Final Values)|-29.43|||<|0.001|2-Sided|95.0|-33.47|-25.39|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).|
1732913|NCT00529373|3190432|Other||Mean Difference (Final Values)|-0.77||||0.896|2-Sided|95.0|-12.34|10.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).|
1732914|NCT00529373|3190432|Other||Mean Difference (Final Values)|-7.64|||<|0.001|2-Sided|95.0|-11.87|-3.41|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).|
1732915|NCT00529373|3190432|Other||Mean Difference (Final Values)|-9.29|||<|0.001|2-Sided|95.0|-13.45|-5.13|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).|
1732916|NCT00529373|3190432|Other||Mean Difference (Final Values)|-12.01|||<|0.001|2-Sided|95.0|-15.22|-8.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).|
1732917|NCT00529373|3190432|Other||Mean Difference (Final Values)|-14.13|||<|0.001|2-Sided|95.0|-17.0|-11.27|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. Longitudinal model includes terms for treatment, stratum, region and interaction between treatment and time as fixed effects (LS Means weighted for region and stratum size).|
1732918|NCT00529373|3190433|Other||Difference in Least Squares Means|-44.54|||<|0.001|2-Sided|95.0|-61.72|-27.36|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48.|
1732919|NCT00529373|3190433|Other||Difference in Least Squares Means|-59.14|||<|0.001|2-Sided|95.0|-66.04|-52.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36.|
1732920|NCT00529373|3190433|Other||Difference in Least Squares Means|-56.68|||<|0.001|2-Sided|95.0|-62.52|-50.84|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24.|
1732921|NCT00529373|3190433|Other||Difference in Least Squares Means|-53.59|||<|0.001|2-Sided|95.0|-58.39|-48.79|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12.|
1732922|NCT00529373|3190433|Other||Difference in Least Squares Means|-51.7|||<|0.001|2-Sided|95.0|-56.11|-47.28|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6.|
1732923|NCT00529373|3190434|Other||Difference in Least Squares Means|-18.73||||0.05|2-Sided|95.0|-37.44|-0.01|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48.|
1732924|NCT00529373|3190434|Other||Difference in Least Squares Means|-44.67||||0.05|2-Sided|95.0|-52.62|-36.72|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36.|
1732925|NCT00529373|3190434|Other||Difference in Least Squares Means|-46.7|||<|0.001|2-Sided|95.0|-53.23|-40.17|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24.|
1732926|NCT00529373|3190434|Other||Difference in Least Squares Means|-60.01|||<|0.001|2-Sided|95.0|-66.4|-53.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12.|
1732927|NCT00529373|3190434|Other||Difference in Least Squares Means|-58.99|||<|0.001|2-Sided|95.0|-64.68|-53.3|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6.|
1732928|NCT00529373|3190435|Other||Difference in Least Squares Means|1.55||||0.617|2-Sided|95.0|-4.92|8.02|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732929|NCT00529373|3190435|Other||Difference in Least Squares Means|1.21||||0.104|2-Sided|95.0|-0.25|2.67|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732930|NCT00529373|3190435|Other||Difference in Least Squares Means|1.05||||0.129|2-Sided|95.0|-0.31|2.4|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732931|NCT00529373|3190435|Other||Difference in Least Squares Means|1.08||||0.083|2-Sided|95.0|-0.14|2.31|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732932|NCT00529373|3190436|Other||Difference in Least Squares Means|11.76|||<|0.001|2-Sided|95.0|9.15|14.36|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1733039|NCT00529087|3190519|Superiority or Other (legacy)||Treatment Difference|7.0||||0.212||95.0|-4.0|18.0|||Chi-squared||||
1732933|NCT00529373|3190436|Other||Difference in Least Squares Means|8.49|||<|0.001|2-Sided|95.0|7.81|9.16|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732934|NCT00529373|3190436|Other||Difference in Least Squares Means|6.03|||<|0.001|2-Sided|95.0|5.47|6.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732935|NCT00529373|3190436|Other||Difference in Least Squares Means|3.44|||<|0.001|2-Sided|95.0|2.98|3.9|||Longitudinal model|Includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size)||Odanacatib 50 mg OW - Placebo at Month 12|
1732936|NCT00529373|3190437|Other||Difference in Least Squares Means|9.08|||<|0.001|2-Sided|95.0|6.97|11.19|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732937|NCT00529373|3190437|Other||Difference in Least Squares Means|6.09|||<|0.001|2-Sided|95.0|5.56|6.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732938|NCT00529373|3190437|Other||Difference in Least Squares Means|4.33|||<|0.001|2-Sided|95.0|3.87|4.78|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732939|NCT00529373|3190437|Other||Difference in Least Squares Means|2.21|||<|0.001|2-Sided|95.0|1.83|2.59|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732940|NCT00529373|3190438|Other||Difference in Least Squares Means|8.54|||<|0.001|2-Sided|95.0|7.0|10.09|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732941|NCT00529373|3190438|Other||Difference in Least Squares Means|5.86|||<|0.001|2-Sided|95.0|5.41|6.3|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732942|NCT00529373|3190438|Other||Difference in Least Squares Means|4.21|||<|0.001|2-Sided|95.0|3.84|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732943|NCT00529373|3190438|Other||Difference in Least Squares Means|2.4|||<|0.001|2-Sided|95.0|2.11|2.68|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732944|NCT00529373|3190439|Other||Difference in Least Squares Means|9.51|||<|0.001|2-Sided|95.0|7.96|11.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732945|NCT00529373|3190439|Other||Difference in Least Squares Means|7.62|||<|0.001|2-Sided|95.0|7.11|8.13|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732946|NCT00529373|3190439|Other||Difference in Least Squares Means|4.02|||<|0.001|2-Sided|95.0|3.67|4.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732947|NCT00529373|3190439|Other||Difference in Least Squares Means|5.79|||<|0.001|2-Sided|95.0|5.37|6.2|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732948|NCT00529373|3190440|Other||Difference in Least Squares Means|3.5||||0.001|2-Sided|95.0|1.46|5.54|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732949|NCT00529373|3190440|Other||Difference in Least Squares Means|2.2||||0.001|2-Sided|95.0|0.89|3.51|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732950|NCT00529373|3190440|Other||Difference in Least Squares Means|1.93|||<|0.001|2-Sided|95.0|1.38|2.47|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732951|NCT00529373|3190440|Other||Difference in Least Squares Means|1.35|||<|0.001|2-Sided|95.0|0.85|1.84|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732952|NCT00529373|3190440|Other||Difference in Least Squares Means|1.11|||<|0.001|2-Sided|95.0|0.67|1.55|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732953|NCT00529373|3190441|Other||Difference in Least Squares Means|13.81|||<|0.001|2-Sided|95.0|12.58|15.04|||Longitudinal model|Includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size)||Odanacatib 50 mg OW - Placebo at Month 60|
1732954|NCT00529373|3190441|Other||Difference in Least Squares Means|12.44|||<|0.001|2-Sided|95.0|11.66|13.22|||Longitudinal model|Includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size)||Odanacatib 50 mg OW - Placebo at Month 48|
1732955|NCT00529373|3190441|Other||Difference in Least Squares Means|9.27|||<|0.001|2-Sided|95.0|8.98|9.57|||Longitudinal model|Includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size)||Odanacatib 50 mg OW - Placebo at Month 36|
1732956|NCT00529373|3190441|Other||Difference in Least Squares Means|6.41|||<|0.001|2-Sided|95.0|6.17|6.65|||Longitudinal model|Includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size)||Odanacatib 50 mg OW - Placebo at Month 24|
1732957|NCT00529373|3190441|Other||Difference in Least Squares Means|3.5|||<|0.001|2-Sided|95.0|3.31|3.7|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732958|NCT00529373|3190441|Other||Difference in Least Squares Means|1.74|||<|0.001|2-Sided|95.0|1.03|2.46|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732959|NCT00529373|3190442|Other||Difference in Least Squares Means|8.53|||<|0.001|2-Sided|95.0|7.54|9.53|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732960|NCT00529373|3190442|Other||Difference in Least Squares Means|8.42|||<|0.001|2-Sided|95.0|7.82|9.02|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732961|NCT00529373|3190442|Other||Difference in Least Squares Means|6.46|||<|0.001|2-Sided|95.0|6.24|6.68|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732962|NCT00529373|3190442|Other||Difference in Least Squares Means|4.38|||<|0.001|2-Sided|95.0|4.19|4.57|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732963|NCT00529373|3190442|Other||Difference in Least Squares Means|2.21|||<|0.001|2-Sided|95.0|2.05|2.37|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732964|NCT00529373|3190442|Other||Difference in Least Squares Means|1.49|||<|0.001|2-Sided|95.0|0.95|2.03|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732965|NCT00529373|3190443|Other||Difference in Least Squares Means|11.23|||<|0.001|2-Sided|95.0|10.23|12.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732966|NCT00529373|3190443|Other||Difference in Least Squares Means|9.72|||<|0.001|2-Sided|95.0|9.16|10.27|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732967|NCT00529373|3190443|Other||Difference in Least Squares Means|7.84|||<|0.001|2-Sided|95.0|7.62|8.06|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732968|NCT00529373|3190443|Other||Difference in Least Squares Means|6.05|||<|0.001|2-Sided|95.0|5.87|6.23|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732969|NCT00529373|3190443|Other||Difference in Least Squares Means|4.07|||<|0.001|2-Sided|95.0|3.93|4.22|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732970|NCT00529373|3190443|Other||Difference in Least Squares Means|2.96|||<|0.001|2-Sided|95.0|2.47|3.46|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732971|NCT00529373|3190444|Other||Difference in Least Squares Means|9.49|||<|0.001|2-Sided|95.0|8.7|10.29|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 60. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732972|NCT00529373|3190444|Other||Difference in Least Squares Means|8.62|||<|0.001|2-Sided|95.0|8.11|9.12|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 48. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732973|NCT00529373|3190444|Other||Difference in Least Squares Means|6.44|||<|0.001|2-Sided|95.0|6.25|6.64|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 36. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732974|NCT00529373|3190444|Other||Difference in Least Squares Means|4.47|||<|0.001|2-Sided|95.0|4.31|4.62|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 24. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732975|NCT00529373|3190444|Other||Difference in Least Squares Means|2.49|||<|0.001|2-Sided|95.0|2.37|2.61|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 12. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732976|NCT00529373|3190444|Other||Difference in Least Squares Means|1.32|||<|0.001|2-Sided|95.0|0.9|1.75|||Longitudinal model|||Odanacatib 50 mg OW - Placebo at Month 6. The longitudinal model includes terms for treatment, stratum, region & interaction between treatment & time as fixed effects (LS means weighted for region & stratum size).|
1732977|NCT00529373|3190445|Other||Odds Ratio (OR)|0.89||||0.014|2-Sided|95.0|0.81|0.98|||Logistic model|||Odanacatib 50 mg OW versus Placebo. Treatment comparison for height loss at any time during the treatment period. The logistic model contained terms for treatment, geographic region and stratum.|
1732978|NCT00529373|3190446|Other||Difference in Least Squares Means|0.01||||0.041|2-Sided|95.0|0.0|0.03|||Mixed Models Analysis|||Odanacatib 50 mg OW versus Placebo. The mixed model contained fixed effects for treatment, region, stratum, treatment-year interaction and random effect intercept and slope (year) and unstructured covariance matrix.|
1732979|NCT00529373|3190447|Other||Hazard Ratio (HR)|0.28|||<|0.001|2-Sided|95.0|0.19|0.4|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.|
1732980|NCT00529373|3190448|Other|Miettinen & Nurminen|Difference in rates|0.27|||||2-Sided|95.0|-0.04|0.58|||||||
1732981|NCT00529373|3190449|Other|Miettinen & Nurminen|Difference in rates|1.52|||||2-Sided|95.0|-1.8|4.84|||||||
1732982|NCT00529373|3190450|Other||Difference in Least Squares Means|0.09|||||2-Sided|95.0|-0.09|0.28||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|
1732983|NCT00529373|3190450|Other||Difference in Least Squares Means|0.03|||||2-Sided|95.0|-0.12|0.17||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|
1732984|NCT00529373|3190450|Other||Difference in Least Squares Means|0.08|||||2-Sided|95.0|-0.06|0.21||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|
1732985|NCT00529373|3190450|Other||Difference in Least Squares Means|0.04|||||2-Sided|95.0|-0.08|0.15||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|
1732986|NCT00529373|3190451|Other||Difference in Least Squares Means|0.19|||||2-Sided|95.0|-0.24|0.62||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|
1732987|NCT00529373|3190451|Other||Difference in Least Squares Means|0.19|||||2-Sided|95.0|-0.15|0.54||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|
1732988|NCT00529373|3190451|Other||Difference in Least Squares Means|0.14|||||2-Sided|95.0|-0.15|0.44||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|
1732989|NCT00529373|3190451|Other||Difference in Least Squares Means|0.11|||||2-Sided|95.0|-0.16|0.38||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|
1732990|NCT00529373|3190452|Other||Mean Difference (Final Values)|-0.21|||||2-Sided|95.0|-0.5|0.08||||||Odanacatib 50 mg OW - Placebo at Month 48. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|
1732991|NCT00529373|3190452|Other||Mean Difference (Final Values)|-0.04|||||2-Sided|95.0|-0.17|0.09||||||Odanacatib 50 mg OW - Placebo at Month 36. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|
1732992|NCT00529373|3190452|Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.12|0.12||||||Odanacatib 50 mg OW - Placebo at Month 24. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|
1732993|NCT00529373|3190452|Other||Mean Difference (Final Values)|-0.02|||||2-Sided|95.0|-0.14|0.09||||||Odanacatib 50 mg OW - Placebo at Month 12. Longitudinal model includes terms for treatment, stratum (sarcopenia, non-sarcopenia), time and interaction between treatment and time as fixed effects (LS means weighted for stratum size).|
1732994|NCT00529373|3190453|Other||Difference in Least Squares Means|26.45|||<|0.001|2-Sided|95.0|16.49|36.4|||Longitudinal model|||Odanacatib 50 mg vs Placebo|
1732995|NCT00529373|3190454|Other||Difference in Least Squares Means|8.92|||<|0.001|2-Sided|95.0|3.9|13.93|||Longitudinal model|||Odanacatib 50 mg vs Placebo|
1732996|NCT00529373|3190458|Other|Miettinen & Nurminen|Difference in rates|0.11|||||2-Sided|95.0|-0.16|0.37|||||||
1732997|NCT00529373|3190459|Other|Miettinen & Nurminen|Difference in rates|0.88|||||2-Sided|95.0|-2.3|4.07|||||||
1732998|NCT00529373|3190460|Other||Hazard Ratio (HR)|0.74|||<|0.001|2-Sided|95.0|0.66|0.83|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.|
1732999|NCT00529373|3190461|Other||Hazard Ratio (HR)|0.52|||<|0.001|2-Sided|95.0|0.4|0.67|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.|
1733040|NCT00529087|3190519|Superiority or Other (legacy)||Treatment Difference|20.4|||<|0.001||95.0|9.5|31.3|||Chi-squared||||
1733041|NCT00529087|3190521|Superiority or Other (legacy)||Treatment Difference|0.7||||0.011||95.0|0.2|1.2|||ANCOVA|Treatment as factor and baseline weekly RFBM as covariate|||
1733000|NCT00529373|3190462|Other||Hazard Ratio (HR)|0.48|||<|0.001|2-Sided|95.0|0.42|0.55|||Generalized linear model|||Odanacatib 50 mg OW vs Placebo. Generalized linear model for binary data with cloglog link and terms for time interval, treatment, stratum, and geographic region. cloglog link = complementary log log transformation of probability of an event up to the time-point.|
1733001|NCT00529373|3190463|Other||Hazard Ratio (HR)|0.77|||<|0.001|2-Sided|95.0|0.68|0.87|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.|
1733002|NCT00529373|3190464|Other||Hazard Ratio (HR)|0.53|||<|0.001|2-Sided|95.0|0.39|0.71|||Regression, Cox|||Odanacatib 50 mg OW vs Placebo. The Cox proportional hazards model included terms for treatment, stratum and geographic region.|
1733003|NCT00529373|3190465|Other||Hazard Ratio (HR)|0.46|||<|0.001|2-Sided|95.0|0.4|0.53|||Generalized linear model|||Odanacatib 50 mg OW vs Placebo. Generalized linear model for binary data with cloglog link and terms for time interval, treatment, stratum, and geographic region. cloglog link = complementary log log transformation of probability of an event up to the time-point.|
1733004|NCT00529152|3190490|Superiority or Other|||||||0.0005|||||||Regression, Linear|||Change in Serum Ferritin from baseline to week 24 was compared using regression analysis; null hypothesis was defined as no change in serum ferritin from baseline to week 24|
1733005|NCT00529087|3190503|Superiority or Other (legacy)||Mean Difference (Final Values)|4.3||||0.237||95.0|-2.8|11.5|||ANCOVA|Treatment as factor, baseline as covariate|||
1733006|NCT00529087|3190503|Superiority or Other (legacy)||Mean Difference (Final Values)|7.6||||0.038||95.0|0.4|14.7|||ANCOVA|Treatment as factor, baseline as covariate|||
1733007|NCT00529087|3190504|Superiority or Other (legacy)||Mean Difference (Final Values)|6.6||||0.087||95.0|-1.0|14.2|||ANCOVA|Treatment as factor, baseline as covariate|||
1733008|NCT00529087|3190504|Superiority or Other (legacy)||Mean Difference (Final Values)|7.0||||0.071||95.0|-0.6|14.5|||ANCOVA|Treatment as factor, baseline as covariate|||
1733009|NCT00529087|3190506|Superiority or Other (legacy)||Treatment Difference|2.8||||0.258||95.0|-2.0|7.6|||ANCOVA|Treatment as factor, baseline as covariate|||
1733010|NCT00529087|3190506|Superiority or Other (legacy)||Treatment Difference|5.6||||0.023||95.0|0.8|10.4|||ANCOVA|Treatment as factor, baseline as covariate|||
1733011|NCT00529087|3190507|Superiority or Other (legacy)||Mean Difference (Final Values)|0.9||||0.779||95.0|-5.6|7.5|||ANCOVA|Treatment as factor, Baseline as covariate|||
1733012|NCT00529087|3190507|Superiority or Other (legacy)||Mean Difference (Final Values)|1.1||||0.731||95.0|-5.4|7.7|||ANCOVA|Treatment as factor, Baseline as covariate|||
1733013|NCT00529087|3190510|Superiority or Other (legacy)||Treatment Difference|-0.2||||0.015||95.0|-0.5|0.0|||ANCOVA|Treatment as factor, Baseline as covariate|||
1733014|NCT00529087|3190510|Superiority or Other (legacy)||Treatment Difference|-0.3||||0.008||95.0|-0.5|-0.1|||ANCOVA|Treatment as factor, Baseline as covariate|||
1733015|NCT00529087|3190511|Superiority or Other (legacy)||Mean Difference (Final Values)|0.2||||0.119||95.0|-0.1|0.5|||ANCOVA|Treatment as factor, Baseline as covariate|||
1733016|NCT00529087|3190511|Superiority or Other (legacy)||Mean Difference (Final Values)|0.5||||0.002||95.0|0.2|0.7|||ANCOVA|Treatment as factor, Baseline as covariate|||
1733017|NCT00529087|3190512|Superiority or Other (legacy)||Mean Difference (Final Values)|0.5||||0.012||95.0|0.1|0.9|||ANCOVA|Treatment as factor, Baseline as covariate|||
1733018|NCT00529087|3190512|Superiority or Other (legacy)||Mean Difference (Final Values)|1.2|||<|0.001||95.0|0.8|1.6|||ANCOVA|Treatment as factor, Baseline as covariate|||
1733019|NCT00529087|3190513|Superiority or Other (legacy)||Treatment Difference|0.4|||<|0.001||95.0|0.0|0.9|||ANCOVA||||
1733020|NCT00529087|3190513|Superiority or Other (legacy)||Treatment Difference|1.1|||<|0.001||95.0|0.6|1.5|||ANCOVA||||
1733021|NCT00529087|3190514|Superiority or Other (legacy)||Mean Difference (Final Values)|0.4||||0.102||95.0|-0.1|0.8|||ANCOVA|Treatment as factor, Baseline as covariate|||
1733022|NCT00529087|3190514|Superiority or Other (legacy)||Mean Difference (Final Values)|1.4|||<|0.001||95.0|1.0|1.9|||ANCOVA|Treatment as factor, Baseline as covariate|||
1733023|NCT00529087|3190515|Superiority or Other (legacy)||Treatment Difference|13.3||||0.016||95.0|2.6|24.0|||Chi-squared||||
1733024|NCT00529087|3190515|Superiority or Other (legacy)||Treatment Difference|19.7|||<|0.001||95.0|9.4|30.1|||Chi-squared||||
1733025|NCT00529087|3190516|Superiority or Other (legacy)||Treatment Difference|5.6||||0.316||95.0|-5.3|16.5|||Chi-squared||||
1733026|NCT00529087|3190516|Superiority or Other (legacy)||Treatment Difference|21.0|||<|0.001||95.0|10.2|31.9|||Chi-squared||||
1733027|NCT00529087|3190517|Superiority or Other (legacy)||Mean Difference (Final Values)|10.7|||<|0.001||95.0|6.2|15.2|||ANOVA|Treatment as a factor||6 hours|
1733028|NCT00529087|3190517|Superiority or Other (legacy)||Mean Difference (Final Values)|19.7|||<|0.001||95.0|15.2|24.1|||ANOVA|Treatment as a factor||6 hours|
1733029|NCT00529087|3190517|Superiority or Other (legacy)||Mean Difference (Final Values)|11.0|||<|0.001||95.0|6.6|15.4|||ANOVA|Treatment as a factor||4 hours|
1733030|NCT00529087|3190517|Superiority or Other (legacy)||Mean Difference (Final Values)|19.5|||<|0.001||95.0|15.2|23.9|||ANOVA|Treatment as a factor||4 hours|
1733031|NCT00529087|3190517|Superiority or Other (legacy)||Mean Difference (Final Values)|11.0|||<|0.001||95.0|6.7|15.3|||ANOVA|Treatment as a factor||3 hours|
1733032|NCT00529087|3190517|Superiority or Other (legacy)||Mean Difference (Final Values)|19.3|||<|0.001||95.0|15.0|23.5|||ANOVA|Treatment as a factor||3 hours|
1733033|NCT00529087|3190517|Superiority or Other (legacy)||Mean Difference (Final Values)|10.4|||<|0.001||95.0|6.3|14.5|||ANOVA|Treatment as a factor||2 hours|
1733034|NCT00529087|3190517|Superiority or Other (legacy)||Mean Difference (Final Values)|18.5|||<|0.001||95.0|14.4|22.5|||ANOVA|Treatment as a factor||2 hours|
1733035|NCT00529087|3190517|Superiority or Other (legacy)||Mean Difference (Final Values)|8.0|||<|0.001||95.0|4.6|11.4|||ANOVA|Treatment as a factor||1 hour|
1733036|NCT00529087|3190517|Superiority or Other (legacy)||Mean Difference (Final Values)|14.5|||<|0.001||95.0|11.2|17.9|||ANOVA|Treatment as a factor||1 hour|
1733042|NCT00529087|3190521|Superiority or Other (legacy)||Treatment Difference|1.6|||<|0.001||95.0|1.1|2.1|||ANCOVA|Treatment as factor and baseline weekly RFBM as covariate|||
1733043|NCT00529087|3190522|Superiority or Other (legacy)||||||<|0.001|||||||Log Rank|Log-rank test for comparisons of survival distributions|||
1733044|NCT00529087|3190523|Superiority or Other (legacy)||Treatment Difference|20.9|||<|0.001||95.0|16.1|25.7|||t-test, 2 sided||||
1733045|NCT00529087|3190523|Superiority or Other (legacy)||Treatment Difference|19.5|||<|0.001||95.0|15.1|24.0|||t-test, 2 sided||||
1733046|NCT00529087|3190524|Superiority or Other (legacy)||Treatment Difference|24.4|||<|0.001||95.0|17.3|31.4|||Chi-squared||||
1733047|NCT00528970|3190532|Other||Mean Difference (Final Values)|9.1||||0.208||||||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by surgery type and region for comparisons of survival distributions for active MOA versus Placebo group.|
1733048|NCT00528970|3190532|Other||Mean Difference (Final Values)|2.0||||0.944||||||Threshold for significance at 0.05 level.|Log Rank|||Analysis was performed using log-rank test stratified by surgery type and region for comparisons of survival distributions for active MOA versus Placebo group.|
1733049|NCT00528957|3190577|Non-Inferiority|In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA < 400 copies/mL was 92% for subjects switching to tenofovir DF and 90% for subjects continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at −15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA < 400 copies/mL at Week 48.|Difference in percentages between groups|-0.9|||||2-Sided|95.0|-13.7|11.8|||||The difference between the two proportions and its CI were based on normal approximation methods.||
1733050|NCT00528957|3190578|Non-Inferiority or Equivalence|In the randomized phase, it was assumed that the respective proportions of participants maintaining HIV-1 RNA < 400 copies/mL was 92% for participants switching to tenofovir DF and 90% for participants continuing stavudine or zidovudine, as estimated from previous GSI studies. The equivalence limit was set at −15% for the lower boundary of a two-sided 95% confidence interval (CI) on the difference in proportions of participants maintaining HIV-1 RNA < 400 copies/mL at Week 48.|Difference in percentages between groups|-8.5|||||2-Sided|95.0|-21.5|4.5|||||Difference is for tenofovir DF minus stavudine or zidovudine (randomized phase)|"The statistical hypotheses for the primary endpoint was as follows:~Null Hypothesis: tenofovir DF group is more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA concentrations < 400 copies/mL at Week 48.~Alternate Hypothesis: tenofovir DF group is no more than 15% worse than the stavudine or zidovudine group with respect to the proportion of participants maintaining HIV-1 RNA < 400 copies/mL at Week 48."|
1733051|NCT00528879|3190584|Superiority or Other||Mean Difference (Final Values)|11.3||||0.0149||||||Statistically significant according to hierarchical testing procedure (p<0.05).|Modified logistic regression||||
1733052|NCT00528879|3190584|Superiority or Other||Mean Difference (Final Values)|0.7||||0.8627|||||||Modified logistic regression||||
1733053|NCT00528879|3190584|Superiority or Other||Mean Difference (Final Values)|6.9|||||||||||||||
1733054|NCT00528879|3190585|Superiority or Other||Mean Difference (Final Values)|-17.7|Standard Error of the Mean|2.808|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733055|NCT00528879|3190585|Superiority or Other||Mean Difference (Final Values)|-13.1|Standard Error of the Mean|2.762|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733056|NCT00528879|3190585|Superiority or Other||Mean Difference (Final Values)|-7.1|Standard Error of the Mean|2.769|<||||||||||||
1733057|NCT00528879|3190586|Superiority or Other||Mean Difference (Final Values)|-0.57|Standard Error of the Mean|0.1146|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733058|NCT00528879|3190586|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.1129|<|0.0004||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733059|NCT00528879|3190586|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.1109|<||||||||||||
1733060|NCT00528879|3190593|Superiority or Other||Mean Difference (Final Values)|-2.08|Standard Error of the Mean|0.3791|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733061|NCT00528879|3190593|Superiority or Other||Mean Difference (Final Values)|-2.19|Standard Error of the Mean|0.3745|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733062|NCT00528879|3190593|Superiority or Other||Mean Difference (Final Values)|-1.38|Standard Error of the Mean|0.3681|<||||||||||||
1733063|NCT00528879|3190594|Superiority or Other||Mean Difference (Final Values)|-0.78|Standard Error of the Mean|0.3535||0.029||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733064|NCT00528879|3190594|Superiority or Other||Mean Difference (Final Values)|-0.84|Standard Error of the Mean|0.3022||0.0068||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733065|NCT00528879|3190594|Superiority or Other||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|0.3515|||||||||||||
1733066|NCT00528879|3190595|Superiority or Other||Mean Difference (Final Values)|14.7||||0.0062||||||Statistically significant according to hierarchical testing procedure (p<0.05).|Modified logistic regression||||
1733067|NCT00528879|3190595|Superiority or Other||Mean Difference (Final Values)|11.7||||0.0275||||||Statistically significant according to hierarchical testing procedure (p<0.05).|Modified logistic regression||||
1733068|NCT00528879|3190595|Superiority or Other||Median Difference (Final Values)|7.1||||0.1775||||||Statistically significant according to hierarchical testing procedure (p<0.05).|Modified logistic regression||||
1733069|NCT00528879|3190596|Superiority or Other||Mean Difference (Final Values)|-1.97|Standard Error of the Mean|0.3365|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733070|NCT00528879|3190596|Superiority or Other||Mean Difference (Final Values)|-2.16|Standard Error of the Mean|0.3344|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733071|NCT00528879|3190596|Superiority or Other||Mean Difference (Final Values)|-1.32|Standard Error of the Mean|0.3344|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733072|NCT00528879|3190597|Superiority or Other||Mean Difference (Final Values)|-17.5|Standard Error of the Mean|3.819|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733073|NCT00528879|3190597|Superiority or Other||Mean Difference (Final Values)|-15.5|Standard Error of the Mean|3.781|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733074|NCT00528879|3190597|Superiority or Other||Mean Difference (Final Values)|-11.8|Standard Error of the Mean|3.774|<|0.0019||||||Statistically significant according to hierarchical testing procedure (p<0.05).|ANCOVA||||
1733075|NCT00528879|3190598|Superiority or Other||Mean Difference (Final Values)|-0.54|Standard Error of the Mean|0.1021|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA||||
1733076|NCT00528879|3190598|Superiority or Other||Mean Difference (Final Values)|-0.41|Standard Error of the Mean|0.1016|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA||||
1733077|NCT00528879|3190598|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.1014|<|0.0002||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA||||
1733078|NCT00528801|3190619|Superiority or Other||Difference in proportions|0.11||||0.048||95.0|0.026|0.199|||Fisher Exact|||Null hypothesis is no difference between cases and controls in the proportion of subjects with lacunae. This was tested using a Fisher's Exact Test.|
1733079|NCT00528801|3190620|Superiority or Other||Mean Difference (Final Values)|-5.5|Standard Error of the Mean|2.07||0.008||95.0|||||Mixed Models Analysis|Adjusted for gender, age, and education.|Cases are lower than controls.|Null hypothesis is no difference between cases and controls in the WAIS-III Perormance IQ (PIQ) Index. A linear model controlling for gender, age, and education was used to compare controls versus cases using an F statistic. Based on sample-size calculations, 120 patients and 36 controls were needed to have 80% power to detect an 8-point difference on the WAIS-III PIQ Index.|
1733080|NCT00528606|3190639|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||p-value based on Cochran-Mantel-Haenszel test comparing treatment groups, stratified by baseline severity group and joint type.|
1733081|NCT00528567|3190643|Superiority or Other||Hazard Ratio (HR)|0.9||||0.3309|2-Sided|95.0|0.72|1.12|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.||
1733082|NCT00528567|3190645|Superiority or Other||Hazard Ratio (HR)|0.87||||0.1832|2-Sided|95.0|0.72|1.07|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.||
1733083|NCT00528567|3190647|Superiority or Other||Hazard Ratio (HR)|0.89||||0.2792|2-Sided|95.0|0.72|1.1|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.||
1733084|NCT00528567|3190650|Superiority or Other||Hazard Ratio (HR)|0.84||||0.2318|2-Sided|95.0|0.64|1.12|||Log Rank||||
1733085|NCT00528567|3190651|Superiority or Other||Hazard Ratio (HR)|0.87||||0.1966|2-Sided|95.0|0.71|1.07|||Log Rank||Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.||
1733086|NCT00528567|3190653|Superiority or Other||Hazard Ratio (HR)|0.93||||0.5247|2-Sided|95.0|0.74|1.17|||Log Rank|Stratification factors are Axillary nodal status, Choice of adjuvant chemotherapy, Hormone receptor status, Surgery|||
1733087|NCT00528567|3190655|Superiority or Other||Hazard Ratio (HR)|0.87||||0.181|2-Sided|95.0|0.72|1.07|||Log Rank|Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.|||
1733088|NCT00528372|3190734|Superiority or Other||Difference from placebo|-0.97|Standard Error of the Mean|0.7135||||95.0|-2.37|0.44|||||||
1733089|NCT00528372|3190734|Superiority or Other||Difference from placebo|-1.27|Standard Error of the Mean|0.7257|||2-Sided|95.0|-2.69|0.16|||||||
1733090|NCT00528372|3190734|Superiority or Other||Difference from placebo|-1.87|Standard Error of the Mean|0.7394|||2-Sided|95.0|-3.33|-0.42|||||||
1733091|NCT00528372|3190734|Superiority or Other||Mean Difference (Final Values)|-0.96|Standard Error of the Mean|0.7078|||||||||||||
1733092|NCT00528372|3190734|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.7371|||||||||||||
1733093|NCT00528372|3190734|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.736|||||||||||||
1733094|NCT00528372|3190735|Superiority or Other||Percent difference from placebo|11.4|||||2-Sided|95.0|-1.0|23.9|||||||
1733095|NCT00528372|3190735|Superiority or Other||Percent difference from placebo|11.3|||||2-Sided|95.0|-1.8|24.4|||||||
1733096|NCT00528372|3190735|Superiority or Other||Percent difference from placebo|18.8|||||2-Sided|95.0|5.5|32.1|||||||
1733097|NCT00528372|3190735|Superiority or Other||Mean Difference (Final Values)|8.6|Standard Error of the Mean|6.334|||||||||||||
1733098|NCT00528372|3190735|Superiority or Other||Mean Difference (Final Values)|12.1|Standard Error of the Mean|6.761|||||||||||||
1733099|NCT00528372|3190735|Superiority or Other||Mean Difference (Final Values)|12.6|Standard Error of the Mean|6.526|||||||||||||
1733100|NCT00528372|3190736|Superiority or Other||Difference from placebo|-0.58|Standard Error of the Mean|0.1704|||2-Sided|95.0|-0.92|-0.25|||||||
1733101|NCT00528372|3190736|Superiority or Other||Difference from placebo|-0.55|Standard Error of the Mean|0.1741|||2-Sided|95.0|-0.89|-0.21|||||||
1733102|NCT00528372|3190736|Superiority or Other||Difference from placebo|-0.6|Standard Error of the Mean|0.1798|||2-Sided|95.0|-0.95|-0.25|||||||
1733103|NCT00528372|3190736|Superiority or Other||Mean Difference (Final Values)|-0.67|Standard Error of the Mean|0.1708|||||||||||||
1733104|NCT00528372|3190736|Superiority or Other||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.175|||||||||||||
1733105|NCT00528372|3190736|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.175|||||||||||||
1733106|NCT00528372|3190737|Superiority or Other||Difference from placebo|-0.87|Standard Error of the Mean|0.6103|||2-Sided|95.0|-2.06|0.33|||||||
1733107|NCT00528372|3190737|Superiority or Other||Difference from placebo|-1.27|Standard Error of the Mean|0.7257|||2-Sided|95.0|-2.69|0.16|||||||
1733110|NCT00528372|3190737|Superiority or Other||Mean Difference (Final Values)|-2.19|Standard Error of the Mean|0.6828|||||||||||||
1733111|NCT00528372|3190737|Superiority or Other||Mean Difference (Final Values)|-1.45|Standard Error of the Mean|0.6979|||||||||||||
1733112|NCT00528372|3190738|Superiority or Other||Percent difference from placebo|19.9|||||2-Sided|95.0|5.3|34.5|||||||
1733113|NCT00528372|3190738|Superiority or Other||Percent difference from placebo|12.4|||||2-Sided|95.0|-2.5|27.3|||||||
1733114|NCT00528372|3190738|Superiority or Other||Percent difference from placebo|19.8|||||2-Sided|95.0|4.9|34.7|||||||
1733115|NCT00528372|3190738|Superiority or Other||Percentage difference|19.2|||||||||||||||
1733116|NCT00528372|3190738|Superiority or Other||Percentage difference|12.6|||||||||||||||
1733117|NCT00528372|3190738|Superiority or Other||Percentage difference|9.7|||||||||||||||
1733118|NCT00528372|3190740|Superiority or Other||Difference from placebo|-17.9|Standard Error of the Mean|4.228|||2-Sided|95.0|-26.2|-9.5|||||||
1733119|NCT00528372|3190740|Superiority or Other||Difference from placebo|-16.2|Standard Error of the Mean|4.321|||2-Sided|95.0|-24.7|-7.7|||||||
1733120|NCT00528372|3190740|Superiority or Other||Difference from placebo|-12.0|Standard Error of the Mean|4.223|||2-Sided|95.0|-20.3|-3.7|||||||
1733121|NCT00528372|3190740|Superiority or Other||Mean Difference (Final Values)|-13.6|Standard Error of the Mean|4.176|||||||||||||
1733122|NCT00528372|3190740|Superiority or Other||Mean Difference (Final Values)|-13.9|Standard Error of the Mean|4.342|||||||||||||
1733123|NCT00528372|3190740|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|4.324|||||||||||||
1733124|NCT00528372|3190742|Superiority or Other||Difference from placebo|-0.87|Standard Error of the Mean|0.6103|||2-Sided|95.0|-2.06|0.33|||||||
1733125|NCT00528372|3190742|Superiority or Other||Difference from placebo|-1.36|Standard Error of the Mean|0.6279|||2-Sided|95.0|-2.6|-0.13|||||||
1733126|NCT00528372|3190742|Superiority or Other||Difference from placebo|-1.63|Standard Error of the Mean|0.6254|||2-Sided|95.0|-2.86|-0.41|||||||
1733127|NCT00528372|3190742|Superiority or Other||Mean Difference (Final Values)|-0.97|Standard Error of the Mean|0.6223||0.1189||||||Tested following a sequential testing procedure at alpha=0.05.|ANCOVA||||
1733128|NCT00528372|3190742|Superiority or Other||Mean Difference (Final Values)|-0.65|Standard Error of the Mean|0.6388||0.3101||||||Tested following a sequential testing procedure at alpha=0.05.|ANCOVA||||
1733129|NCT00528372|3190742|Superiority or Other||Mean Difference (Final Values)|-1.06|Standard Error of the Mean|0.6307|||||||||||||
1733130|NCT00528372|3190744|Superiority or Other||Difference from placebo|-25.5|Standard Error of the Mean|5.567|||2-Sided|95.0|-36.4|-14.5|||||||
1733131|NCT00528372|3190744|Superiority or Other||Difference from placebo|-23.3|Standard Error of the Mean|5.711|||2-Sided|95.0|-34.4|-12.0|||||||
1733132|NCT00528372|3190744|Superiority or Other||Difference from placebo|-21.5|Standard Error of the Mean|5.686|||2-Sided|95.0|-32.6|-10.3|||||||
1733133|NCT00528372|3190744|Superiority or Other||Mean Difference (Final Values)|-24.7|Standard Error of the Mean|5.626|<|0.0001||||||Statistically significant according to hierarchical testing procedure (p<0.05)|ANCOVA||Week 24||
1733134|NCT00528372|3190744|Superiority or Other||Mean Difference (Final Values)|-19.9|Standard Error of the Mean|5.806|<|0.0007||||||Statistically significant according to hierarchical testing procedure (p<0.05)|ANCOVA||Week 24||
1733135|NCT00528372|3190744|Superiority or Other||Mean Difference (Final Values)|-11.1|Standard Error of the Mean|5.734|<||||||||||Week 24||
1733136|NCT00528372|3190745|Superiority or Other||Difference from placebo|-0.56|Standard Error of the Mean|0.1474|||2-Sided|95.0|-0.85|-0.27|||||||
1733137|NCT00528372|3190745|Superiority or Other||Difference from placebo|-0.56|Standard Error of the Mean|0.1527|||2-Sided|95.0|-0.86|-0.26|||||||
1733138|NCT00528372|3190745|Superiority or Other||Difference from placebo|-0.61|Standard Error of the Mean|0.1536|||2-Sided|95.0|-0.91|-0.3|||||||
1733139|NCT00528372|3190745|Superiority or Other||Median Difference (Final Values)|-0.66|Standard Error of the Mean|0.1518|<|0.0001||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA||||
1733140|NCT00528372|3190745|Superiority or Other||Median Difference (Final Values)|-0.54|Standard Error of the Mean|0.1541|<|0.0005||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA||||
1733141|NCT00528372|3190745|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.1522|<|0.0207||||||Tested at alpha=0.019, applying the Dunnett adjustment|ANCOVA||||
1733142|NCT00528112|3190753|Superiority or Other||failure rate|0.01445|||||2-Sided|95.0|0.00823|0.02531||||||Cumulative failure rate (Kaplan-Meier) at 5 years|
1733143|NCT00528112|3190775|Superiority or Other||failure rate|0.01||||||95.0|0.005|0.018||||||Cumulative failure rate (Kaplan-Meier) at 3 years|
1733144|NCT00528112|3190775|Superiority or Other||failure rate|0.009|||||2-Sided|95.0|0.005|0.017||||||Cumulative failure rate (Kaplan-Meier) at 3 years|
1733145|NCT00527943|3190778|Superiority or Other||Cox Proportional Hazard|0.93||||0.606|2-Sided|95.0|0.7|1.23|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733146|NCT00527943|3190779|Superiority or Other||Cox Proportional Hazard|1.05||||0.515|2-Sided|95.0|0.9|1.23|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733147|NCT00527943|3190780|Superiority or Other||Cox Proportional Hazard|1.07||||0.493|2-Sided|95.0|0.88|1.31|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733166|NCT00527735|3190822|Superiority or Other||Hazard Ratio (HR)|0.753||||0.1287|2-Sided|95.0|0.461|1.232|||1-sided Log Rank||||
1741651|NCT00432809|3203957|Superiority or Other|||||||0.87|||||||ANOVA||||
1733148|NCT00527943|3190781|Superiority or Other||Cox Proportional Hazard|1.14||||0.418|2-Sided|95.0|0.83|1.58|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733149|NCT00527943|3190782|Superiority or Other||Cox Proportional Hazard|0.88||||0.021|2-Sided|95.0|0.79|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733150|NCT00527943|3190783|Superiority or Other||Cox Proportional Hazard|1.0||||0.963|2-Sided|95.0|0.83|1.22|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733151|NCT00527943|3190784|Superiority or Other||Cox Proportional Hazard|0.93||||0.108|2-Sided|95.0|0.86|1.02|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733152|NCT00527943|3190785|Superiority or Other||Cox Proportional Hazard|0.94||||0.174|2-Sided|95.0|0.87|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733153|NCT00527943|3190786|Superiority or Other||Cox Proportional Hazard|0.9||||0.027|2-Sided|95.0|0.81|0.99|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733154|NCT00527943|3190787|Superiority or Other||Cox Proportional Hazard|0.91||||0.038|2-Sided|95.0|0.84|1.0|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733155|NCT00527943|3190788|Superiority or Other||Cox Proportional Hazard|1.41|||<|0.001|2-Sided|95.0|1.29|1.54|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733156|NCT00527943|3190789|Superiority or Other||Cox Proportional Hazard|1.36|||<|0.001|2-Sided|95.0|1.18|1.57|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733157|NCT00527943|3190790|Superiority or Other||Cox Proportional Hazard|0.89||||0.018|2-Sided|95.0|0.81|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733158|NCT00527943|3190791|Superiority or Other||Cox Proportional Hazard|0.92||||0.072|2-Sided|95.0|0.85|1.01|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733159|NCT00527826|3190809|Non-Inferiority or Equivalence|Poisson model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).||||||0.66|||||||Poisson model|Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.|||
1733160|NCT00527826|3190811|Non-Inferiority or Equivalence|Negative binomial model for the rate of exacerbations (per year) using the treatment duration as offset term and treatment, COPD severity (stratum) and interaction as fixed factors. This model took further into account a strata imbalance of 73% COPD III vs. 27% COPD IV according to the observed rates (SAS code: proc GENMOD).||||||0.73|||||||Negative binomial model|Least square means adjusted for COPD severity (stratum), interaction of stratum with treatment, and strata imbalance of 73% COPD III vs. 27% COPD IV.|||
1733161|NCT00527787|3190816|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1733162|NCT00527787|3190817|Superiority or Other|||||||0.003|||||||Cochran-Mantel-Haenszel||||
1733163|NCT00527787|3190818|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1733164|NCT00527787|3190819|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1733165|NCT00527787|3190820|Superiority or Other||proportions|4.1||||0.001|2-Sided|95.0|1.9|7.7|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjetcs developing gastric ulcers throughout 6 months of study treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 6 months. The cumulative proportion of subjects developing gastric ulcers at 6 months was analyzed using the CMH test stratified by use of low-dose aspirin (Yes/No) at randomization.|
1741652|NCT00432809|3203958|Superiority or Other|||||||0.03|||||||ANOVA||||
1733167|NCT00527735|3190822|Superiority or Other||Hazard Ratio (HR)|0.947||||0.4132|2-Sided|95.0|0.585|1.536|||1-sided Log Rank||||
1733168|NCT00527735|3190825|Superiority or Other||Hazard Ratio (HR)|0.927||||0.37|2-Sided|95.0|0.591|1.453|||1-sided Log Rank||||
1733169|NCT00527735|3190825|Superiority or Other||Hazard Ratio (HR)|0.933||||0.3846|2-Sided|95.0|0.588|1.481|||1-sided Log Rank||||
1733170|NCT00527735|3190834|Superiority or Other||Hazard Ratio (HR)|0.64||||0.0282|2-Sided|95.0|0.403|1.1016|||1-sided log rank||||
1733171|NCT00527735|3190834|Superiority or Other||Hazard Ratio (HR)|0.751||||0.1098|2-Sided|95.0|0.475|1.188|||1-sided log rank||||
1733172|NCT00527735|3190841|Superiority or Other||Hazard Ratio (HR)|0.866||||0.234|2-Sided|95.0|0.587|1.278|||1-sided log rank||||
1733173|NCT00527735|3190841|Superiority or Other||Hazard Ratio (HR)|0.988||||0.4759|2-Sided|95.0|0.669|1.46|||1-sided log rank||||
1733174|NCT00527735|3190842|Superiority or Other||Hazard Ratio (HR)|0.691||||0.024|2-Sided|95.0|0.478|0.999|||One-sided log rank||||
1733175|NCT00527735|3190842|Superiority or Other||Hazard Ratio (HR)|0.882||||0.2502|2-Sided|95.0|0.612|1.271|||One-sided log rank||||
1733176|NCT00527735|3190843|Superiority or Other||Hazard Ratio (HR)|0.724||||0.0473|2-Sided|95.0|0.495|1.059|||1-sided log rank||||
1733177|NCT00527735|3190843|Superiority or Other||Hazard Ratio (HR)|0.806||||0.1302|2-Sided|95.0|0.553|1.174|||1-sided log rank||||
1733178|NCT00527618|3190848|Superiority or Other|||||||0.67|||||||Mixed Models Analysis||||
1733179|NCT00527618|3190849|Superiority or Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)||||
1733180|NCT00527618|3190850|Superiority or Other||Risk Ratio (RR)|0.95||||0.78|2-Sided|95.0|0.66|1.37|||Random effects poission regression|Adjusted for age.||We estimated that 26 participants would be required to detect a 50% reduction in genital HSV shedding with 80% power, at a two-sided type I error rate of 5%.|
1733181|NCT00527618|3190851|Superiority or Other||Slope|-0.27|||<|0.001|2-Sided|95.0|-0.41|-0.14|||Mixed Models Analysis|Adjusted for baseline plasma HIV-1 RNA.|Acyclovir was coded as 0 and valacyclovir as 1. The beta-coefficient (slope) indicates the average difference in HIV-1 RNA on valacyclovir and acyclovir; a negative number indicates that plasma HIV-1 RNA was lower on valacyclovir than acyclovir.|We estimated that a sample size of 29 participants, with 4 weeks of weekly plasma HIV-1 RNA levels per treatment arm, would be required to detect a 0.25 log10 copies/ml difference in plasma HIV-1 RNA between the study arms with 80% power, at a two-sided type I error rate of 5%.|
1733182|NCT00527605|3190867|Superiority or Other||Median Difference (Final Values)|-14.23|||<|0.0001||95.0|-20.23|-8.22|||t-test, 2 sided||Dutasteride arm minus placebo arm.||
1733183|NCT00527514|3190874|Superiority or Other||||||<|0.0001||||||No multiplicity adjustments|one-sample t-test||||
1733184|NCT00527514|3190875|Superiority or Other||||||<|0.0001||||||No multiplicity adjustments|One-sample t-test||||
1733185|NCT00527514|3190876|Superiority or Other||||||<|0.0001||||||No multiplicity adjustments|one-sample t-test||||
1733186|NCT00527514|3190877|Superiority or Other||||||<|0.0001||||||No multiplicity adjustments|One-sample t-test||||
1733187|NCT00527514|3190878|Superiority or Other||||||<|0.0001||||||No multiplicity adjustments|One-sample t-test|||Statistical analysis parameters apply to both the daytime and nighttime rows.|
1733188|NCT00527514|3190879|Superiority or Other||||||<|0.0001||||||No multiplicity adjustments|one-sample t-test|||The sample size of this study was not based on the statistical power consideration and was considered as sufficient for the evaluation of the efficacy and safety of the proposed olmesartan medoxomil-based treatment regimen.|
1733189|NCT00527124|3190925|Superiority or Other|||||||0.7425|||||||Log Rank||||
1733190|NCT00527124|3190925|Superiority or Other||Hazard Ratio (HR)|0.907|Standard Error of the Mean|0.2973||0.7428|2-Sided|95.0|0.506|1.624|||Regression, Cox||||
1733191|NCT00527072|3190932|Superiority or Other||proportion|0.646||||0.05|2-Sided|95.0|0.577|0.711|||exact binomial distribution||||
1733192|NCT00527072|3190933|Superiority or Other||proportion|0.791||||0.05|2-Sided|95.0|0.73|0.844|||exact binomial distribution||||
1733193|NCT00527072|3190934|Superiority or Other||Proportion|0.654||||0.05|2-Sided|95.0|0.586|0.718|||exact binomial distribution|||null hypothesis H0: proportion = 0.30|
1733194|NCT00526890|3190939|Other|||||||0.3149|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events.|
1733195|NCT00526669|3190974|Superiority or Other||percentage of participants|29.0|||||2-Sided|95.0|17.9|40.3|||||The estimated value reflects the percentage of participants who achieved progression-free survival.||
1733196|NCT00526669|3190975|Superiority or Other||percentage of participants|17.9|||||2-Sided|95.0|9.6|29.2|||||The estimated value represents the percentage of participants with complete response or partial response.||
1733197|NCT00526669|3190976|Superiority or Other|||||||0.38||||||Biomarker: HER3|Wilcoxon signed rank test||||
1733198|NCT00526669|3190976|Superiority or Other|||||||0.26||||||Biomarker: HER2|Wilcoxon signed rank test||||
1733199|NCT00526669|3190976|Superiority or Other|||||||0.1||||||Biomarker: EGFR/HER1|Wilcoxon signed rank test||||
1733200|NCT00526669|3190976|Superiority or Other|||||||0.097||||||Biomarker: DPD|Wilcoxon signed rank test||||
1733201|NCT00526669|3190976|Superiority or Other|||||||0.1||||||Biomarker: TS|Wilcoxon signed rank test||||
1733202|NCT00526474|3190992|Superiority or Other||Cox Proportional Hazard|0.89||||0.003|2-Sided|95.0|0.83|0.96|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733203|NCT00526474|3190993|Superiority or Other||Cox Proportional Hazard|0.86||||0.019|2-Sided|95.0|0.76|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733296|NCT00526097|3191108|Superiority or Other||Odds Ratio (OR)|0.2||||0.0035||95.0|0.06|0.63|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733204|NCT00526474|3190994|Superiority or Other||Cox Proportional Hazard|0.92||||0.249|2-Sided|95.0|0.8|1.06|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733205|NCT00526474|3190995|Superiority or Other||Cox Proportional Hazard|0.67||||0.002|2-Sided|95.0|0.52|0.87|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733206|NCT00526474|3190996|Superiority or Other||Cox Proportional Hazard|0.88||||0.127|2-Sided|95.0|0.74|1.04|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733207|NCT00526474|3190997|Superiority or Other||Cox Proportional Hazard|0.82||||0.002|2-Sided|95.0|0.73|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733208|NCT00526474|3190998|Superiority or Other||Cox Proportional Hazard|0.86||||0.108|2-Sided|95.0|0.71|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733209|NCT00526474|3190999|Superiority or Other||Cox Proportional Hazard|0.88|||<|0.001|2-Sided|95.0|0.83|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733210|NCT00526474|3191000|Superiority or Other||Cox Proportional Hazard|0.89|||<|0.001|2-Sided|95.0|0.83|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733211|NCT00526474|3191001|Superiority or Other||Cox Proportional Hazard|0.83|||<|0.001|2-Sided|95.0|0.77|0.9|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733212|NCT00526474|3191002|Superiority or Other||Cox Proportional Hazard|0.83|||<|0.001|2-Sided|95.0|0.75|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733213|NCT00526474|3191003|Superiority or Other||Cox Proportional Hazard|0.86|||<|0.001|2-Sided|95.0|0.79|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733214|NCT00526474|3191004|Superiority or Other||Cox Proportional Hazard|1.42|||<|0.001|2-Sided|95.0|1.31|1.54|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733215|NCT00526474|3191005|Superiority or Other||Cox Proportional Hazard|1.45|||<|0.001|2-Sided|95.0|1.23|1.71|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733216|NCT00526474|3191006|Superiority or Other||Cox Proportional Hazard|0.8|||<|0.001|2-Sided|95.0|0.73|0.89|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733217|NCT00526474|3191007|Superiority or Other||Cox Proportional Hazard|0.83|||<|0.001|2-Sided|95.0|0.76|0.9|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733218|NCT00526474|3191008|Superiority or Other||Cox Proportional Hazard|0.89|||<|0.001|2-Sided|95.0|0.83|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733297|NCT00526097|3191109|Superiority or Other||Odds Ratio (OR)|0.24||||0.2524||95.0|0.02|2.67|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733760|NCT00519584|3192072|Superiority||Hazard Ratio (HR)|0.17|||<|0.001|2-Sided|95.0|0.08|0.39|||Log Rank||Ropivacaine/dex vs. Ropivacaine/saline||
1733219|NCT00526474|3191009|Superiority or Other||Cox Proportional Hazard|0.83||||0.001|2-Sided|95.0|0.74|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733220|NCT00526474|3191010|Superiority or Other||Cox Proportional Hazard|0.95||||0.411|2-Sided|95.0|0.85|1.07|||Cox Proportional Hazards Regression||Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733221|NCT00526474|3191011|Superiority or Other||Cox Proportional Hazard|0.97||||0.733|2-Sided|95.0|0.83|1.14|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733222|NCT00526474|3191012|Superiority or Other||Cox Proportional Hazard|0.88||||0.108|2-Sided|95.0|0.75|1.03|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733223|NCT00526474|3191013|Superiority or Other||Cox Proportional Hazard|0.83||||0.001|2-Sided|95.0|0.74|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733224|NCT00526474|3191014|Superiority or Other||Cox Proportional Hazard|0.89||||0.151|2-Sided|95.0|0.76|1.04|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733225|NCT00526474|3191015|Superiority or Other||Cox Proportional Hazard|0.9|||<|0.001|2-Sided|95.0|0.85|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733226|NCT00526474|3191016|Superiority or Other||Cox Proportional Hazard|0.91||||0.001|2-Sided|95.0|0.86|0.96|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733227|NCT00526474|3191017|Superiority or Other||Cox Proportional Hazard|0.87|||<|0.001|2-Sided|95.0|0.81|0.93|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733228|NCT00526474|3191018|Superiority or Other||Cox Proportional Hazard|0.86||||0.002|2-Sided|95.0|0.78|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733229|NCT00526474|3191019|Superiority or Other||Cox Proportional Hazard|0.91||||0.009|2-Sided|95.0|0.85|0.98|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733230|NCT00526474|3191020|Superiority or Other||Cox Proportional Hazard|1.41|||<|0.001|2-Sided|95.0|1.31|1.51|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733231|NCT00526474|3191021|Superiority or Other||Cox Proportional Hazard|1.51|||<|0.001|2-Sided|95.0|1.31|1.74|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733232|NCT00526474|3191022|Superiority or Other||Cox Proportional Hazard|0.87|||<|0.001|2-Sided|95.0|0.8|0.94|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733233|NCT00526474|3191023|Superiority or Other||Cox Proportional Hazard|0.88||||0.001|2-Sided|95.0|0.82|0.95|||Cox Proportional Hazards Regression|Hazard Ratio calculated with covariates for treatment and stratification factors|Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.||
1733234|NCT00526227|3191028|Superiority or Other||Percentage|0.0||||||97.0|0.0|7.7|||||The one-sided 97% exact binomial upper confidence bound was 7.7% which was calculated using 44 patients from the interim analysis results.||
1733298|NCT00526097|3191110|Superiority or Other||Odds Ratio (OR)|0.19|||<|0.0001||95.0|0.09|0.41|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733235|NCT00526188|3191029|Superiority or Other||Mean Difference (Final Values)|11.36||||||95.0|7.45|15.28|||||Comparison was combined pre- and post-contrast MRI minus pre-contrast MRI|Difference in precision of lesion characterization between combined pre and post contrast MRI and pre contrast MRI image set was calculated. Null hypothesis: No difference between combined pre- and post-contrast MRI and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided.|
1733236|NCT00526188|3191030|Superiority or Other||Mean Difference (Final Values)|4.81||||||95.0|1.84|7.78|||||Comparison was post-contrast MRI minus pre-contrast MRI (for investigator's result)|Difference in sensitivity of lesion detection between post- and pre-contrast MRI image sets, based on investigators assessments was calculated. Null hypothesis: No difference between post and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the investigators difference. This CI had a confidence level of 95% and was two-sided.|
1733237|NCT00526188|3191031|Superiority or Other||Mean Difference (Final Values)|9.46||||||95.0|6.0|12.93|||||Comparison was post-contrast MRI minus pre-contrast MRI|Difference in sensitivity of lesion detection between post- and pre-contrast MRI image set was calculated. Null hypothesis: No difference between post- and pre-contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided. The study was planned with a power of 80%.|
1733238|NCT00526162|3191036|Other||percentage|0.0|||<|0.03|1-Sided|97.0||||Using a confidence interval of 97%, the exact binomial upper confidence bound was 9.5% which is lower than the 10% set for the primary safety objective. Therefore, the actual p-value has not been calculated further.|One proportion binomial exact||The confidence interval was calculated based on 35 patients who completed 1-month follow-up at interim analysis.||
1733239|NCT00526097|3191051|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.08|<|0.0001||95.0|-0.8|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733240|NCT00526097|3191052|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.13|<|0.0001||95.0|-1.5|-1.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733241|NCT00526097|3191053|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.07||0.007||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733242|NCT00526097|3191054|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.09|<|0.0001||95.0|-1.0|-0.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733243|NCT00526097|3191055|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.08|<|0.0001||95.0|-0.6|-0.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733244|NCT00526097|3191056|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.7||0.378||95.0|-0.8|2.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733245|NCT00526097|3191057|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|0.87||0.129||95.0|-0.4|3.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733246|NCT00526097|3191058|Superiority or Other||Mean Difference (Final Values)|3.5|Standard Error of the Mean|1.58||0.0273||95.0|0.4|6.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733247|NCT00526097|3191059|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|1.94||0.7543||95.0|-3.2|4.4||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733248|NCT00526097|3191060|Superiority or Other||Mean Difference (Final Values)|1.2|Standard Error of the Mean|2.14||0.5849||95.0|-3.0|5.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733249|NCT00526097|3191061|Superiority or Other||Mean Difference (Final Values)|4.3|Standard Error of the Mean|1.74||0.013||95.0|0.9|7.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733299|NCT00526097|3191111|Superiority or Other|||||||0.0951|||||||Fisher Exact||||
1733250|NCT00526097|3191062|Superiority or Other||Mean Difference (Final Values)|2.0|Standard Error of the Mean|1.34||0.1407||95.0|-0.7|4.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733251|NCT00526097|3191063|Superiority or Other||Mean Difference (Final Values)|2.1|Standard Error of the Mean|2.31||0.3567||95.0|-2.4|6.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733252|NCT00526097|3191064|Superiority or Other||Mean Difference (Final Values)|1.0|Standard Error of the Mean|2.05||0.6129||95.0|-3.0|5.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733253|NCT00526097|3191065|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|2.01||0.798||95.0|-3.4|4.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733254|NCT00526097|3191066|Superiority or Other|||||||0.0058||||||Exact p-value|Wilcoxon rank sum test||||
1733255|NCT00526097|3191067|Superiority or Other||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test||||
1733256|NCT00526097|3191068|Superiority or Other||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test||||
1733257|NCT00526097|3191069|Superiority or Other||||||<|0.0001||||||Exact p-value|Wilcoxon rank sum test||||
1733258|NCT00526097|3191070|Superiority or Other|||||||0.0005|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733259|NCT00526097|3191071|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733260|NCT00526097|3191072|Superiority or Other|||||||0.0002|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733261|NCT00526097|3191073|Superiority or Other|||||||0.6773|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733262|NCT00526097|3191074|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733263|NCT00526097|3191075|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733264|NCT00526097|3191076|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733265|NCT00526097|3191077|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733266|NCT00526097|3191078|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733267|NCT00526097|3191079|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733268|NCT00526097|3191080|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733269|NCT00526097|3191081|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733270|NCT00526097|3191082|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733271|NCT00526097|3191083|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733272|NCT00526097|3191084|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733273|NCT00526097|3191085|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for baseline|||
1733274|NCT00526097|3191086|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.04||0.0018||95.0|-0.2|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733275|NCT00526097|3191087|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.04|<|0.0001||95.0|-0.2|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733276|NCT00526097|3191088|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.04|<|0.0001||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733277|NCT00526097|3191089|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.03|<|0.0001||95.0|-0.2|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733278|NCT00526097|3191090|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.09|<|0.0001||95.0|-0.8|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733279|NCT00526097|3191091|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.09|<|0.0001||95.0|-0.9|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733280|NCT00526097|3191092|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.09|<|0.0001||95.0|-1.0|-0.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733281|NCT00526097|3191093|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.08|<|0.0001||95.0|-0.9|-0.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733282|NCT00526097|3191094|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.06||0.0064||95.0|-0.3|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733283|NCT00526097|3191095|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.06||0.0127||95.0|-0.2|0.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733284|NCT00526097|3191096|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.05||0.0003||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733285|NCT00526097|3191097|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.05||0.0002||95.0|-0.3|-0.1||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733286|NCT00526097|3191098|Superiority or Other||Mean Difference (Final Values)|2.0|Standard Error of the Mean|0.16|<|0.0001||95.0|1.7|2.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733287|NCT00526097|3191099|Superiority or Other||Mean Difference (Final Values)|2.3|Standard Error of the Mean|0.15|<|0.0001||95.0|2.0|2.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733288|NCT00526097|3191100|Superiority or Other||Mean Difference (Final Values)|2.4|Standard Error of the Mean|0.14|<|0.0001||95.0|2.1|2.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733289|NCT00526097|3191101|Superiority or Other||Mean Difference (Final Values)|2.6|Standard Error of the Mean|0.14|<|0.0001||95.0|2.4|2.9||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733290|NCT00526097|3191102|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.1|<|0.0001||95.0|-0.9|-0.5||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733291|NCT00526097|3191103|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.1|<|0.0001||95.0|-1.1|-0.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733292|NCT00526097|3191104|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.09|<|0.0001||95.0|-1.2|-0.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733293|NCT00526097|3191105|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.08|<|0.0001||95.0|-1.2|-0.9||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733294|NCT00526097|3191106|Superiority or Other||Odds Ratio (OR)|0.27||||0.0086||95.0|0.1|0.69|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733295|NCT00526097|3191107|Superiority or Other||Odds Ratio (OR)|0.06||||0.0004||95.0|0.01|0.46|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733300|NCT00526097|3191112|Superiority or Other||Odds Ratio (OR)|1.19||||1||95.0|0.37|3.77|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733301|NCT00526097|3191113|Superiority or Other||Odds Ratio (OR)|1.84||||0.4002||95.0|0.52|6.47|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733302|NCT00526097|3191114|Superiority or Other||Odds Ratio (OR)|4.08||||0.0105||95.0|1.26|13.24|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733303|NCT00526097|3191115|Superiority or Other||Odds Ratio (OR)|2.5||||0.0025||95.0|1.32|4.74|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733304|NCT00526097|3191116|Superiority or Other||Odds Ratio (OR)|2.46|||<|0.0001||95.0|1.81|3.35|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733305|NCT00526097|3191117|Superiority or Other||Odds Ratio (OR)|17.13|||<|0.0001||95.0|4.28|68.66|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733306|NCT00526097|3191118|Superiority or Other||Odds Ratio (OR)|1.52|||<|0.0001||95.0|1.24|1.88|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733307|NCT00526097|3191119|Superiority or Other||Odds Ratio (OR)|1.7|||<|0.0001||95.0|1.37|2.11|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733308|NCT00526097|3191120|Superiority or Other||Odds Ratio (OR)|2.08|||<|0.0001||95.0|1.62|2.66|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733309|NCT00526097|3191121|Superiority or Other||Odds Ratio (OR)|1.75|||<|0.0001||95.0|1.44|2.13|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733310|NCT00526097|3191122|Superiority or Other||Odds Ratio (OR)|2.04|||<|0.0001||95.0|1.62|2.57|||Fisher Exact||OR: Bisacodyl / Placebo; The exact 95% confidence interval (CI) by Clopper and Pearson is presented||
1733311|NCT00526097|3191123|Superiority or Other||||||<|0.0001|||||||Log Rank|||The log-rank test was used to calculate the p-value and to test for differences between the treatment groups.|
1733312|NCT00526097|3191124|Superiority or Other||Mean Difference (Final Values)|3.7|Standard Error of the Mean|0.43|<|0.0001||95.0|2.9|4.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733313|NCT00526097|3191125|Superiority or Other||Mean Difference (Final Values)|3.8|Standard Error of the Mean|0.45|<|0.0001||95.0|2.9|4.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733314|NCT00526097|3191126|Superiority or Other||Mean Difference (Final Values)|4.7|Standard Error of the Mean|0.46|<|0.0001||95.0|3.8|5.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733315|NCT00526097|3191127|Superiority or Other||Mean Difference (Final Values)|6.7|Standard Error of the Mean|0.49|<|0.0001||95.0|5.8|7.7||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733316|NCT00526097|3191128|Superiority or Other||Mean Difference (Final Values)|4.9|Standard Error of the Mean|0.43|<|0.0001||95.0|4.1|5.8||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733317|NCT00526097|3191129|Superiority or Other||Mean Difference (Final Values)|2.6|Standard Error of the Mean|0.43|<|0.0001||95.0|1.8|3.4||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733318|NCT00526097|3191130|Superiority or Other||Mean Difference (Final Values)|2.8|Standard Error of the Mean|0.39|<|0.0001||95.0|2.0|3.6||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733319|NCT00526097|3191131|Superiority or Other||Mean Difference (Final Values)|3.5|Standard Error of the Mean|0.43|<|0.0001||95.0|2.7|4.3||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733320|NCT00526097|3191132|Superiority or Other||Mean Difference (Final Values)|4.3|Standard Error of the Mean|0.42|<|0.0001||95.0|3.5|5.2||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs)|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733358|NCT00525512|3191218|Superiority or Other||Mean Difference (Final Values)|0.325|||<|0.0001||95.0|0.226|0.425||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733807|NCT00518986|3192164|Superiority or Other|||||||0.0794||||||P-value for treatment comparison is from Pearson's chi-square test|Chi-squared||||
1733321|NCT00526097|3191133|Superiority or Other||Mean Difference (Final Values)|3.3|Standard Error of the Mean|0.36|<|0.0001||95.0|2.6|4.0||Treatment differences (Bisacodyl - Placebo) were estimated by reference to the adjusted least squares mean differences and the corresponding 95% confidence intervals (CIs).|ANCOVA||Means are adjusted for center effects and baseline value|Analysis of covariance (ANCOVA) including centre as fixed effect and baseline as covariate|
1733322|NCT00526058|3191139|Non-Inferiority or Equivalence|Noninferiority of the Futura system to the Secura system would be demonstrated if the upper bound of the 90% confidence interval (CI) for the difference between the two systems (Secura-Futura) in percent change of LDL-C measurements from pre- to post-treatment is less than the noninferiority margin 5.7%.||||||0.005|||||||ANOVA||||
1733323|NCT00525733|3191164|Superiority or Other|||||||0.46|||||||Chi-squared||||
1733324|NCT00525512|3191184|Superiority or Other||Mean Difference (Final Values)|-4.33||||0.0807||95.0|-9.19|0.53||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA||||
1733325|NCT00525512|3191185|Superiority or Other||Mean Difference (Final Values)|0.02||||0.9896||95.0|-3.44|3.48||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA||||
1733326|NCT00525512|3191186|Superiority or Other||Mean Difference (Final Values)|0.89||||0.6556||95.0|-3.03|4.81||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA||||
1733327|NCT00525512|3191187|Superiority or Other||Mean Difference (Final Values)|-0.61||||0.7071||95.0|-3.81|2.59||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA||||
1733328|NCT00525512|3191188|Superiority or Other||Mean Difference (Final Values)|0.05||||0.4277||95.0|-0.07|0.17||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA||||
1733329|NCT00525512|3191189|Superiority or Other||Mean Difference (Final Values)|0.01||||0.8644||95.0|-0.05|0.06||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA||||
1733330|NCT00525512|3191190|Superiority or Other||Adjusted mean ratio|1.06||||0.4443||95.0|0.91|1.25||Based on a ANCOVA analysis with terms for treatment, centre and baseline.|ANCOVA||||
1733331|NCT00525512|3191191|Superiority or Other||Cox Proportional Hazard|0.94||||0.6541||95.0|0.719|1.23||Based on a MMRM analysis with terms for treatment, centre and baseline.|Regression, Cox||||
1733332|NCT00525512|3191192|Superiority or Other||Mean Difference (Final Values)|-8.94||||0.0001||95.0|-13.37|-4.52||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733333|NCT00525512|3191193|Superiority or Other||Mean Difference (Final Values)|-3.58||||0.0313||95.0|-6.84|-0.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733334|NCT00525512|3191194|Superiority or Other||Mean Difference (Final Values)|-2.33||||0.2029||95.0|-5.91|1.26||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733335|NCT00525512|3191195|Superiority or Other||Mean Difference (Final Values)|-4.03||||0.0072||95.0|-6.97|-1.1||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733336|NCT00525512|3191196|Superiority or Other||Mean Difference (Final Values)|0.07||||||95.0|-3.82|3.96|||||||
1733337|NCT00525512|3191197|Superiority or Other||Mean Difference (Final Values)|0.18||||||95.0|-3.36|3.71|||||||
1733338|NCT00525512|3191198|Superiority or Other||Mean Difference (Final Values)|0.18||||||95.0|-3.53|3.9|||||||
1733339|NCT00525512|3191199|Superiority or Other||Mean Difference (Final Values)|0.15||||||95.0|-3.61|3.92|||||||
1733340|NCT00525512|3191200|Superiority or Other||Mean Difference (Final Values)|0.08||||||95.0|-3.4|3.55|||||||
1733341|NCT00525512|3191201|Superiority or Other||Mean Difference (Final Values)|0.23||||||95.0|-3.05|3.51|||||||
1733342|NCT00525512|3191202|Superiority or Other||Mean Difference (Final Values)|0.37||||||95.0|-2.78|3.52|||||||
1733343|NCT00525512|3191203|Superiority or Other||Mean Difference (Final Values)|0.17||||||95.0|-3.22|3.55|||||||
1733344|NCT00525512|3191204|Superiority or Other||Mean Difference (Final Values)|0.16||||||95.0|-3.1|3.41|||||||
1733345|NCT00525512|3191205|Superiority or Other||Mean Difference (Final Values)|0.22||||||95.0|-3.02|3.46|||||||
1733346|NCT00525512|3191206|Superiority or Other||Mean Difference (Final Values)|0.23||||||95.0|-2.97|3.43|||||||
1733347|NCT00525512|3191207|Superiority or Other||Mean Difference (Final Values)|0.34||||||95.0|-2.91|3.58|||||||
1733348|NCT00525512|3191208|Superiority or Other||Mean Difference (Final Values)|0.33||||||95.0|-2.66|3.31|||||||
1733349|NCT00525512|3191209|Superiority or Other||Mean Difference (Final Values)|0.36||||||95.0|-2.39|3.11|||||||
1733350|NCT00525512|3191210|Superiority or Other||Mean Difference (Final Values)|0.09||||0.6878||95.0|-0.35|0.53||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733351|NCT00525512|3191211|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.9071||95.0|-0.38|0.33||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733352|NCT00525512|3191212|Superiority or Other||Mean Difference (Final Values)|-0.32||||0.1131||95.0|-0.72|0.08||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733353|NCT00525512|3191213|Superiority or Other||Mean Difference (Final Values)|0.333|||<|0.0001||95.0|0.209|0.456||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733354|NCT00525512|3191214|Superiority or Other||Mean Difference (Final Values)|0.254|||<|0.0001||95.0|0.144|0.364||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733355|NCT00525512|3191215|Superiority or Other||Mean Difference (Final Values)|0.3|||<|0.0001||95.0|0.194|0.406||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733356|NCT00525512|3191216|Superiority or Other||Mean Difference (Final Values)|0.259|||<|0.0001||95.0|0.154|0.365||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733357|NCT00525512|3191217|Superiority or Other||Mean Difference (Final Values)|0.353|||<|0.0001||95.0|0.245|0.461||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1734377|NCT00511836|3193213|Superiority or Other||||||<|2e-05|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0.|
1733359|NCT00525512|3191219|Superiority or Other||Mean Difference (Final Values)|0.277|||<|0.0001||95.0|0.179|0.375||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733360|NCT00525512|3191220|Superiority or Other||Mean Difference (Final Values)|0.241|||<|0.0001||95.0|0.128|0.355||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733361|NCT00525512|3191221|Superiority or Other||Mean Difference (Final Values)|0.212||||0.0002||95.0|0.102|0.322||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733362|NCT00525512|3191222|Superiority or Other||Mean Difference (Final Values)|0.161||||0.009||95.0|0.04|0.281||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733363|NCT00525512|3191223|Superiority or Other||Mean Difference (Final Values)|0.234|||<|0.0001||95.0|0.13|0.339||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733364|NCT00525512|3191224|Superiority or Other||Mean Difference (Final Values)|0.182||||0.0006||95.0|0.078|0.286||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733365|NCT00525512|3191225|Superiority or Other||Mean Difference (Final Values)|0.157||||0.0019||95.0|0.058|0.255||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733366|NCT00525512|3191226|Superiority or Other||Mean Difference (Final Values)|0.217|||<|0.0001||95.0|0.127|0.307||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733367|NCT00525512|3191227|Superiority or Other||Mean Difference (Final Values)|0.13|||<|0.0001||95.0|0.077|0.183||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733368|NCT00525512|3191228|Superiority or Other||Mean Difference (Final Values)|0.149|||<|0.0001||95.0|0.097|0.202||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733369|NCT00525512|3191229|Superiority or Other||Mean Difference (Final Values)|0.134|||<|0.0001||95.0|0.083|0.185||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733370|NCT00525512|3191230|Superiority or Other||Mean Difference (Final Values)|0.127|||<|0.0001||95.0|0.077|0.176||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733371|NCT00525512|3191231|Superiority or Other||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.099|0.192||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733372|NCT00525512|3191232|Superiority or Other||Mean Difference (Final Values)|0.162|||<|0.0001||95.0|0.117|0.208||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733373|NCT00525512|3191233|Superiority or Other||Mean Difference (Final Values)|0.154|||<|0.0001||95.0|0.11|0.198||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733374|NCT00525512|3191234|Superiority or Other||Mean Difference (Final Values)|0.075||||0.0059||95.0|0.022|0.128||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733375|NCT00525512|3191235|Superiority or Other||Median Difference (Final Values)|0.094||||0.0002||95.0|0.045|0.144||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733376|NCT00525512|3191236|Superiority or Other||Mean Difference (Final Values)|0.09||||0.0005||95.0|0.04|0.141||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733377|NCT00525512|3191237|Superiority or Other||Mean Difference (Final Values)|0.105|||<|0.0001||95.0|0.058|0.153||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733378|NCT00525512|3191238|Superiority or Other||Mean Difference (Final Values)|0.089||||0.0003||95.0|0.041|0.137||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733379|NCT00525512|3191239|Superiority or Other||Mean Difference (Final Values)|0.082||||0.0005||95.0|0.036|0.128||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733380|NCT00525512|3191240|Superiority or Other||Mean Difference (Final Values)|0.116|||<|0.0001||95.0|0.073|0.16||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733381|NCT00525512|3191241|Superiority or Other||Adjusted mean ratio|1.12||||0.0899||95.0|0.98|1.28||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733382|NCT00525512|3191242|Superiority or Other||Adjusted mean ratio|1.11||||0.0945||95.0|0.98|1.26||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733383|NCT00525512|3191243|Superiority or Other||Adjusted mean ratio|1.18||||0.0041||95.0|1.05|1.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733384|NCT00525512|3191244|Superiority or Other||Adjusted mean ratio|1.15||||0.0131||95.0|1.03|1.29||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733385|NCT00525512|3191245|Superiority or Other||Adjusted mean ratio|1.1||||0.0597||95.0|1.0|1.21||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733386|NCT00525512|3191246|Superiority or Other||Adjusted mean ratio|1.12||||0.008||95.0|1.03|1.23||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733387|NCT00525512|3191247|Superiority or Other||Adjusted mean ratio|1.13||||0.1062||95.0|0.97|1.32||Based on a MMRM analysis with terms for treatment, centre and baseline.|Mixed Models Analysis||||
1733388|NCT00525174|3191253|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of social stigma at 24 weeks.|
1733389|NCT00525174|3191254|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of social stigma at 6 weeks.|
1733390|NCT00525174|3191255|Superiority or Other|||||||0.001|||||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the compliance subscale at 24 weeks.|
1733391|NCT00525174|3191256|Superiority or Other|||||||0.12|||||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the compliance subscale at 6 weeks.|
1734059|NCT00515502|3192719|Superiority or Other||Mean Difference (Final Values)|-5.3|Standard Error of the Mean|3.21|||2-Sided|95.0|-11.8|1.1|||||||
1733392|NCT00525174|3191257|Superiority or Other|||||||0.01|||||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the adverse effects subscale at 24 weeks.|
1733393|NCT00525174|3191258|Superiority or Other|||||||0.9|||||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of the adverse effects subscale at 6 weeks.|
1733394|NCT00525174|3191259|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of impact of treatment at 24 weeks.|
1733395|NCT00525174|3191260|Superiority or Other|||||||0.03|||||||t-test, 2 sided|||A t-test was used to evaluate treatment group difference of impact of treatment at 6 weeks.|
1733396|NCT00525174|3191261|Superiority or Other|||||||0.21|||||||Fisher Exact|||The Fisher exact test was used to compare the proportion of subjects in each treatment group who tested 2 or more logMAR lines worse in the fellow eye at 24 weeks compared with baseline.|
1733397|NCT00525174|3191261|Superiority or Other|||||||0.07|||||||ANCOVA|||A treatment group difference in the fellow eye visual acuity at 24 weeks was evaluated in an ANCOVA model adjusted for the baseline fellow eye acuity.|
1733398|NCT00525174|3191263|Superiority or Other|||||||0.88|||||||Wilcoxon rank-sum|||A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.|
1733399|NCT00525174|3191264|Superiority or Other|||||||0.9|||||||Wilcoxon rank-sum|||A Wilcoxon rank-sum test was used to evaluate change in Randot Preschool stereoacuity levels from baseline to 24 weeks by treatment group.|
1733400|NCT00525174|3191267|Superiority or Other|||||||0.61|||||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients with 3 or more lines of amblyopic eye visual acuity improvement from baseline to 24 weeks.|
1733401|NCT00525174|3191268|Superiority or Other|||||||0.28|||||||Regression, Cox|||The time to first achieve amblyopic eye visual acuity of 20/25 or better was evaluated using a Cox proportional hazard model.|
1733402|NCT00525174|3191268|Superiority or Other|||||||0.86|||||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic visual acuity 20/25 or better at 24 weeks.|
1733403|NCT00525174|3191269|Superiority or Other|||||||0.27|||||||Regression, Logistic|||Logistic regression was used to compare the proportion of patients in each treatment group with amblyopic eye visual acuity within 1 line of the fellow eye or better.|
1733404|NCT00525174|3191271|Superiority or Other|||||||0.21|||||||ANCOVA|||The association of fixation preference while the Bangerter filter was over the fellow eye at baseline (amblyopic eye, fellow eye, alternates) with 24-week amblyopic eye acuity was evaluated in an ANCOVA model.|
1733405|NCT00525174|3191271|Superiority or Other|||||||0.49|||||||ANCOVA|||The relationship between the fellow eye blur from the Bangerter filter at baseline and amblyopic improvement at the 24-week outcome was evaluated with an ANCOVA model with acuity in the fellow eye being categorized as better than versus equal to or worse than acuity in the amblyopic eye.|
1733406|NCT00525174|3191271|Superiority or Other|||||||0.2|||||||Mixed Models Analysis|||Treatment group difference in rate of improvement was evaluated using a population averaged linear mixed model after performing an inverse transformation of time to obtain linearity.|
1733407|NCT00525174|3191271|Superiority or Other||Mean Difference (Net)|0.38||||0.09|2-Sided|95.0|-0.06|0.83|||ANCOVA|The logMAR visual acuity scores were adjusted for baseline amblyopic eye acuity.||In addition to the test of non-inferiority, an efficacy test of Patching over Bangerter filters was also completed.|
1733408|NCT00525174|3191271|Non-Inferiority or Equivalence|The trial was designed as a non-inferiority study. The sample size was computed to be 170 subjects to have 90% power and a type I error rate of 5% for a noninferiority limit of 0.075 logarithm of minimum angle of resolution (logMAR), based on assumed standard deviation of 24-week visual acuity scores of 0.16 logMAR, a correlation between baseline and final acuities of 0.20, and 10% noncompletion of the study primary outcome examination.|Mean Difference (Net)|0.38|||||1-Sided|95.0||0.76||||||The trial was designed as a non-inferiority study. The sample size was computed to be 170 subjects to have 90% power and a type I error rate of 5% for a noninferiority limit of 0.075 logarithm of minimum angle of resolution (logMAR), based on assumed standard deviation of 24-week visual acuity scores of 0.16 logMAR, a correlation between baseline and final acuities of 0.20, and 10% noncompletion of the study primary outcome examination.|
1733409|NCT00525174|3191272|Superiority or Other|||||||0.02|||||||Regression, Logistic|||Logistic regression was performed comparing the proportions of patients in each treatment group who had no improvement or worsening in amblyopic eye visual acuity from baseline to 24 weeks (change from baseline <= +4 letters for E-ETDRS testing).|
1733410|NCT00525161|3191276|Superiority or Other||Median Progression Free Survival|6.1|||||2-Sided|95.0|2.6|11.3|||||||
1733411|NCT00525161|3191277|Superiority or Other||Clinical Response Rate at 3 months|0.0|||||2-Sided||||||||Defined as complete response/partial response after 3 months of adding sorafenib to endocrine therapy|Based on known historical response rate to sorafenib of no better than 5–10%, the study was designed to test the null hypothesis that the clinical response rate is no better than 10% versus the alternative hypothesis that it is at least 25% when sorafenib is added to endocrine therapy. In the first stage, 18 patients were planned for enrollment, and if two or fewer responses were observed, the trial would be terminated. The study stopped after 11 due to slow accrual and withdrawal of funding.|
1733412|NCT00525044|3191293|Other|||||||0.0119|||||||Mantel Haenszel|||"Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."|
1733413|NCT00525044|3191293|Other|||||||0.0343|||||||Mantel Haenszel|||"Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."|
1733414|NCT00525044|3191294|Other|||||||0.5552|||||||Mantel Haenszel|||"Analysis at day 2:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."|
1733415|NCT00525044|3191294|Other|||||||0.9939|||||||Mantel Haenszel|||"Analysis at day 1:~P-value was calculated by the Cochran-Mantel-Haenszel test adjusting for center."|
1733416|NCT00525044|3191295|Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.13||0.0201|2-Sided|95.0|-0.6|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 180 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."|
1733417|NCT00525044|3191295|Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.13||0.0054|2-Sided|95.0|-0.6|-0.1|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 120 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."|
1733418|NCT00525044|3191295|Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.11||0.0417|2-Sided|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 60 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."|
1733419|NCT00525044|3191295|Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.128|2-Sided|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 30 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."|
1733420|NCT00525044|3191296|Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.13||0.0201|2-Sided|95.0|-0.6|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 180 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."|
1733421|NCT00525044|3191296|Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.13||0.0054|2-Sided|95.0|-0.6|-0.1|||ANCOVA||Treatment differences (Ambroxol- Placebo|"Analysis at 120 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."|
1733422|NCT00525044|3191296|Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.11||0.0417|2-Sided|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 60 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."|
1733423|NCT00525044|3191296|Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.128|2-Sided|95.0|-0.4|0.0|||ANCOVA||Treatment differences (Ambroxol- Placebo)|"Analysis at 30 min:~analysis of covariance (ANCOVA) including treatment and centre as fix effects and baseline as covariable are presented. Treatment differences are estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."|
1733424|NCT00525044|3191297|Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.028||0.0156|2-Sided|95.0|-0.12|-0.01|||ANOVA||Treatment differences (Ambroxol- Placebo)|"Differences between the treatment groups with regard to the primary endpoint SPIDnorm was tested using an analysis of variance (ANOVA) including treatment and centre as fix effects.~Treatment differences were estimated by reference to the adjusted least squares mean differences and the corresponding 95 % confidence intervals."|
1733425|NCT00524771|3191302|Non-Inferiority or Equivalence|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.2|2.6|||||Hazard ratio was adjusted for age, BMI, smoking, and treated hypertension.||
1733426|NCT00524771|3191302|Non-Inferiority or Equivalence|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.7|||||2-Sided|95.0|0.2|2.3|||||The hazard ratio was adjusted for age, BMI, Smoking, and treated hypertension.||
1733427|NCT00524771|3191303|Non-Inferiority or Equivalence|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.3|2.3|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of > 12 months.|
1733428|NCT00524771|3191303|Non-Inferiority or Equivalence|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.9|||||2-Sided|95.0|0.3|2.6|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of 6 - 12 months.|
1733429|NCT00524771|3191303|Non-Inferiority or Equivalence|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.3|2.2|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Like analysis 1 (see above) but restricted to exposure period of less than 6 months.|
1733430|NCT00524771|3191303|Non-Inferiority or Equivalence|Sample size calculations were based on the primary statistical analysis (see above).|Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.4|1.7|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COC2 is higher or equal to 2.|
1733431|NCT00524771|3191303|Non-Inferiority or Equivalence|Sample size calculations were based on a non-inferiority test of two exponential survival curves . These calculations are based on the following assumptions: 1) one-sided α of 0.025; 2) power (1-β) of 0.80; VTE incidence rate of 9.1 VTE/10.000 WY and 4) non-inferiority limit on hazard ratio of 2.|Hazard Ratio (HR)|0.9|||||2-Sided|95.0|0.5|1.5|||||Hazard ratio was adjusted age, BMI, duration of current use and family history of VTE.|Tested null hypothesis: VTE hazard ratio for NuvaRing vs. COCs is higher or equal to 2. This analysis represents the a priori defined primary statistical analysis.|
1733432|NCT00524680|3191310|Superiority or Other|||||||0.0631|||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 10000 IU. Statistical analysis was done using one sample t-test.|
1733433|NCT00524680|3191310|Superiority or Other|||||||0.0079|||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 10000 IU. Statistical analysis was done using one sample t-test.|
1733434|NCT00524680|3191310|Superiority or Other|||||||0.2214|||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 10000 IU. Statistical analysis was done using one sample t-test.|
1733435|NCT00524680|3191310|Superiority or Other|||||||0.1348|||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 8000 IU. Statistical analysis was done using one sample t-test.|
1734060|NCT00515502|3192719|Superiority or Other||Mean Difference (Final Values)|-7.7|Standard Error of the Mean|2.91|||2-Sided|95.0|-13.5|-1.8|||||||
1733436|NCT00524680|3191310|Superiority or Other|||||||0.1828|||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 8000 IU. Statistical analysis was done using one sample t-test.|
1733437|NCT00524680|3191310|Superiority or Other|||||||0.8241|||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 8000 IU. Statistical analysis was done using one sample t-test.|
1733438|NCT00524680|3191310|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-month for 6000 IU. Statistical analysis was done using one sample t-test.|
1733439|NCT00524680|3191310|Superiority or Other||||||<|0.9688|||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 6000 IU. Statistical analysis was done using one sample t-test.|
1733440|NCT00524680|3191310|Superiority or Other||||||<|0.1281|||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 6000 IU. Statistical analysis was done using one sample t-test.|
1733441|NCT00524680|3191310|Superiority or Other||||||<|0.1744|||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 6-Month for dose level 4000 IU.|
1733442|NCT00524680|3191310|Superiority or Other||||||<|0.1025|||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 3-month for 4000 IU. Statistical analysis was done using one sample t-test.|
1733443|NCT00524680|3191310|Superiority or Other||||||<|0.8244|||||||t-test, 2 sided|||Change from Baseline in PTH Levels at 1-month for 4000 IU. Statistical analysis was done using one sample t-test.|
1733444|NCT00524680|3191311|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.|
1733445|NCT00524680|3191311|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.|
1733446|NCT00524680|3191311|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 10000 IU. Statistical analysis was done using one sample t-test.|
1733447|NCT00524680|3191311|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.|
1733448|NCT00524680|3191311|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.|
1733449|NCT00524680|3191311|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 8000 IU. Statistical analysis was done using one sample t-test.|
1733450|NCT00524680|3191311|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.|
1733451|NCT00524680|3191311|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.|
1733452|NCT00524680|3191311|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 6000 IU. Statistical analysis was done using one sample t-test.|
1733453|NCT00524680|3191311|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 6-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.|
1733454|NCT00524680|3191311|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 3-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.|
1733455|NCT00524680|3191311|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from Baseline in Serum 25(OH) D3 Levels at 1-Month for dose level 4000 IU. Statistical analysis was done using one sample t-test.|
1733456|NCT00524472|3191341|Superiority or Other||Risk Ratio (RR)|0.88||||0.085|2-Sided|95.0|0.72|1.07|||Cochran-Mantel-Haenszel||HN vs. Standard||
1733457|NCT00524472|3191342|Superiority or Other||Risk Ratio (RR)|1.52||||0.12|2-Sided|95.0|0.74|3.11|||Cochran-Mantel-Haenszel||HN vs. standard||
1733458|NCT00524472|3191343|Superiority or Other||Risk Ratio (RR)|1.13||||0.025|2-Sided|95.0|0.98|1.31|||Regression, Cox||HN vs. Standard||
1733459|NCT00524472|3191344|Superiority or Other||Hazard Ratio (HR)|1.05||||0.99|2-Sided|95.0|0.91|1.21|||Regression, Cox||||
1733460|NCT00524472|3191345|Superiority or Other||Risk Ratio (RR)|0.92||||0.29|2-Sided|95.0|0.75|1.13|||Cochran-Mantel-Haenszel||HN vs. standard||
1733461|NCT00524472|3191346|Superiority or Other||Risk Ratio (RR)|0.62||||0.0043|2-Sided|95.0|0.39|0.97||"P-values for combined sites: significant if P < 0.0085 for efficacy. Adjusted for interim analysis.~Confidence intervals adjusted for interim analysis."|Cochran-Mantel-Haenszel||Hyperinsulinemic-normoglycemic clamp||
1733462|NCT00524368|3191362|Superiority or Other||Difference in least square means|0.55|Standard Error of the Mean|1.79||0.761|2-Sided|95.0|-2.97|4.06|||ANCOVA|Including factors for treatment, and baseline log10 plasma viral load and baseline FAHI score as covariates|Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.||
1733463|NCT00524368|3191363|Superiority or Other||Difference in least square means|-5.95|Standard Error of the Mean|10.26||0.562|2-Sided|95.0|-26.09|14.2|||ANCOVA|The model includes treatment as factor and baseline CD4 count and baseline viral load (log10) as covariates.|Difference in least square means DRV/rtv once daily minus DRV/rtv twice daily estimated from the ANCOVA model.||
1733464|NCT00524368|3191364|Superiority or Other||Difference in least square means|-0.03|Standard Error of the Mean|0.072||0.711|2-Sided|95.0|-0.169|0.115|||ANCOVA|Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load|Difference in least square means between the 2 treatment groups (DRV/rtv q.d. and DRV/rtv b.i.d)||
1733465|NCT00524368|3191365|Superiority or Other||Hazard Ratio, log|0.945|Standard Error of the Mean|0.154||0.716|2-Sided|95.0|0.699|1.279|||Regression, Cox|Including baseline log10 viral load as covariate|||
1733466|NCT00524368|3191366|Superiority or Other||Hazard Ratio (HR)|0.99|Standard Error of the Mean|0.094||0.917|2-Sided|95.0|0.824|1.191|||Cox proportional hazards|Including treatment as fixed factor and baseline plasma viral load as a covariate|||
1734061|NCT00515502|3192719|Superiority or Other||Mean Difference (Final Values)|-4.6|Standard Error of the Mean|2.15|||2-Sided|95.0|-8.9|-0.3|||||||
1733467|NCT00524368|3191367|Superiority or Other||Difference between least square means|-0.003|Standard Error of the Mean|0.094||0.977|2-Sided|95.0|-0.188|0.182|||ANCOVA|Including 1 factor for treatment, and including the covariate baseline log10 plasma viral load|Difference between least square means between the DRV/rtv q.d. and DRV/rtv b.i.d. treatment groups at Week 48.||
1733468|NCT00524368|3191368|Non-Inferiority or Equivalence|If at Week 48, the lower limit of this 95% 2-sided CI of the difference between DRV/rtv q.d. and DRV/rtv b.i.d. exceeded -12%, noninferiority of DRV/rtv q.d. and DRV/rtv b.i.d. could be concluded.|Difference in proportion of response|0.007|Standard Error of the Mean|0.034|<|0.001|2-Sided|95.0|-0.06|0.075|||Regression, Logistic|A logistic regression model includes treatment as fixed factor and baseline plasma viral load as a covariate.|Difference in proportion of response between 2 treatment groups (DRV/rtv q.d. minus DRV/rtv b.i.d)||
1733469|NCT00524368|3191369|Non-Inferiority or Equivalence|If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/rtv once daily and DRV/rtv twice daily exceeds -12%, non-inferiority of the DRV/rtv q.d. versus the DRV/rtv b.i.d. therapy was concluded.|Difference in proportion of response|0.0019|Standard Error of the Mean|0.037|<|0.001|2-Sided|95.0|-0.054|0.092|||Regression, Logistic|The model includes treatment as factor and baseline viral load (log10) as covariate.|Difference in proportion of response DRV/rtv once daily minus DRV/rtv twice daily estimated from the logistic regression model.|Assuming a response rate of 70% at 48 weeks for both treatment groups, 306 participants were required per treatment arm to establish noninferiority of darunavir (DRV)/ritonavir (rtv) once daily versus DRV/rtv twice daily with a maximum allowable difference of 12%, with a 1-sided significance level of 0.025 and 90% power.|
1733470|NCT00524303|3191385|Superiority or Other||Percent Difference|0.0||||1|2-Sided|95.0|-25.1|25.1|||Fisher Exact||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.||
1733471|NCT00524303|3191385|Superiority or Other||Percent Difference|7.0||||0.627|2-Sided|95.0|-17.8|32.5|||Fisher Exact||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the lapatinib arm was calculated.||
1733472|NCT00524303|3191386|Superiority or Other||Percent difference|20.0|||||2-Sided|95.0|-8.0|49.4|||||Approximate 95% confidence interval for the difference in response rates between the transtuzumab arm and the transtuzumab + lapatinib arm was calculated.||
1733473|NCT00524303|3191386|Superiority or Other||Percent difference|-9.0|||||2-Sided|95.0|-38.1|17.9|||||Approximate 95% confidence interval for the difference in response rates between the trastuzumab arm and the lapatinib arm was calculated.||
1733474|NCT00524121|3191403|Superiority or Other|||||||0.5467|||||||Fisher Exact||||
1733475|NCT00524121|3191404|Superiority or Other|||||||1|||||||Fisher Exact||||
1733476|NCT00524121|3191405|Superiority or Other|||||||1|||||||Fisher Exact||||
1733477|NCT00524121|3191406|Superiority or Other|||||||0.115|||||||Log Rank||||
1733478|NCT00524121|3191407|Superiority or Other|||||||0.011|||||||Wilcoxon signed rank test||||
1733479|NCT00524043|3191411|Superiority or Other|||||||0.691||||||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA||||
1733480|NCT00524043|3191412|Superiority or Other|||||||0.126||||||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA||||
1733481|NCT00524043|3191413|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|2.69||0.87||95.0|-4.86|5.74||Based on ANCOVA model with treatment (placebo, paliperidone ER 1.5 mg, and paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA||||
1733482|NCT00524043|3191414|Superiority or Other|||||||0.626||||||Based on ANCOVA model on ranks with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA||||
1733483|NCT00524043|3191415|Superiority or Other||Mean Difference (Final Values)|-3.3|Standard Error of the Mean|4.15||0.431||95.0|-11.46|4.9||Based on ANCOVA model with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|Paliperidone ER 6 mg was used for assay sensitivity|||
1733484|NCT00524043|3191415|Superiority or Other||Mean Difference (Final Values)|2.8|Standard Error of the Mean|4.2||0.504||95.0|-5.47|11.09||Based on ANCOVA model with treatment (Placebo, Paliperidone ER 1.5 mg, and Paliperidone ER 6 mg) and country as factors, and baseline value as a covariate. Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Sample size estimation was based on the assumption that the difference between the paliperidone ER 1.5 mg dose group and the placebo group in the mean change in PANSS total score from baseline to end point was 11 points with a within-group standard deviation of 20 points. It was calculated that 65 patients were needed per treatment group to detect a statistically significant treatment difference between the paliperidone ER 1.5 mg dose group and the placebo group with a power of 87.5%.|
1733485|NCT00524030|3191422|Superiority or Other|||||||0.001|||||||Wald test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood’s formula for variance with continuity correction||H0: Exit rate ≥68%|
1733486|NCT00524030|3191422|Superiority or Other||||||<|0.001|||||||Wald test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood’s formula for variance with continuity correction||H0: Exit rate ≥74%|
1733487|NCT00524030|3191423|Superiority or Other||||||<|0.001|||||||Wald Test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood’s formula for variance with continuity correction||H0: Exite rate ≥68%|
1733488|NCT00524030|3191423|Superiority or Other||||||<|0.001|||||||Wald Test|2-sided 95% adjusted confidence interval constructed using KM product limit estimation and Greenwood’s formula for variance with continuity correction||Null hypothesis (H0): Exit rate greater than or equal to (≥)74%|
1734062|NCT00515502|3192719|Superiority or Other||Mean Difference (Final Values)|-5.2|Standard Error of the Mean|2.24|||2-Sided|95.0|-9.7|-0.7|||||||
1734426|NCT00511004|3193366|Superiority or Other|||||||0.9|||||||Fisher Exact||||
1733489|NCT00523991|3191430|Superiority or Other||Mean Difference (Final Values)|51.46||||0.858||95.0|-512.2|615.12||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733490|NCT00523991|3191431|Superiority or Other||Mean Difference (Final Values)|211.18||||0.45||95.0|-338.04|760.39||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733491|NCT00523991|3191432|Superiority or Other||Mean Difference (Final Values)|258.83||||0.318||95.0|-250.37|768.03||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733492|NCT00523991|3191433|Superiority or Other||Mean Difference (Final Values)|181.99||||0.495||95.0|-341.75|705.73||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||placebo versus tiotropium|
1733493|NCT00523991|3191434|Superiority or Other||Mean Difference (Final Values)|-31.42||||0.899||95.0|-520.19|457.34||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733494|NCT00523991|3191435|Superiority or Other||Mean Difference (Final Values)|-23.54||||0.916||95.0|-464.02|416.94||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733495|NCT00523991|3191437|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.579||95.0|-0.11|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733496|NCT00523991|3191438|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.704||95.0|-0.1|0.07||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo|
1733497|NCT00523991|3191439|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.63||95.0|-0.09|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo|
1733498|NCT00523991|3191440|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.67||95.0|-0.08|0.05||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733499|NCT00523991|3191441|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.204||95.0|-0.1|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733500|NCT00523991|3191442|Superiority or Other||Mean Difference (Final Values)|0.01||||0.819||95.0|-0.05|0.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo|
1733501|NCT00523991|3191444|Superiority or Other|||||||0.446|||||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo|
1733502|NCT00523991|3191445|Superiority or Other|||||||0.622|||||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo|
1733503|NCT00523991|3191446|Superiority or Other|||||||0.205|||||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo|
1733504|NCT00523991|3191447|Superiority or Other|||||||0.215|||||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo|
1733505|NCT00523991|3191448|Superiority or Other|||||||0.8|||||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo|
1733506|NCT00523991|3191449|Superiority or Other|||||||0.196|||||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo|
1733507|NCT00523991|3191450|Superiority or Other|||||||0.996|||||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo|
1733508|NCT00523991|3191451|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.933||95.0|-0.17|0.16||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733509|NCT00523991|3191452|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.927||95.0|-0.16|0.15||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733585|NCT00522548|3191696|Superiority|||||||0.046||||||This p value was for data at week 24. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic Group) in this proof of concept study.|
1733510|NCT00523991|3191453|Superiority or Other||Mean Difference (Final Values)|0.06||||0.455||95.0|-0.09|0.21||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733511|NCT00523991|3191454|Superiority or Other||Mean Difference (Final Values)|0.05||||0.518||95.0|-0.1|0.19||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733512|NCT00523991|3191455|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.219||95.0|-0.2|0.05||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo|
1733513|NCT00523991|3191456|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.358||95.0|-0.18|0.07||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733514|NCT00523991|3191458|Superiority or Other||Mean Difference (Final Values)|0.01||||0.568||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733515|NCT00523991|3191459|Superiority or Other||Mean Difference (Final Values)|0.01||||0.549||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733516|NCT00523991|3191460|Superiority or Other||Mean Difference (Final Values)|0.01||||0.554||95.0|-0.02|0.04||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733517|NCT00523991|3191461|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.61||95.0|-0.03|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733518|NCT00523991|3191462|Superiority or Other||Mean Difference (Final Values)|0.0||||0.78||95.0|-0.02|0.03||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and logarithm of baseline value~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733519|NCT00523991|3191463|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.668||95.0|-0.03|0.02||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and logarithm of baseline value Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo|
1733520|NCT00523991|3191465|Superiority or Other||Mean Difference (Final Values)|-2.33||||0.363||95.0|-7.39|2.73||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733521|NCT00523991|3191466|Superiority or Other||Mean Difference (Final Values)|1.5||||0.306||95.0|-1.39|4.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms for treatment, site, and work productivity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo|
1733522|NCT00523991|3191467|Superiority or Other||Mean Difference (Final Values)|3.43||||0.075||95.0|-0.35|7.21||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733523|NCT00523991|3191468|Superiority or Other||Mean Difference (Final Values)|4.1||||0.051||95.0|-0.02|8.23||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733524|NCT00523991|3191469|Superiority or Other||Mean Difference (Final Values)|5.79||||0.079||95.0|-0.68|12.26||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733525|NCT00523991|3191470|Superiority or Other||Mean Difference (Final Values)|1.74||||0.469||95.0|-3.01|6.49||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733526|NCT00523991|3191472|Superiority or Other||Mean Difference (Final Values)|-4.9||||0.158||95.0|-11.73|1.94||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733527|NCT00523991|3191473|Superiority or Other||Mean Difference (Final Values)|0.16||||0.961||95.0|-6.52|6.84||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733528|NCT00523991|3191474|Superiority or Other||Mean Difference (Final Values)|2.59||||0.471||95.0|-4.51|9.69||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733529|NCT00523991|3191475|Superiority or Other||Mean Difference (Final Values)|3.79||||0.162||95.0|-1.55|9.13||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733530|NCT00523991|3191476|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.912||95.0|-7.9|7.06||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733531|NCT00523991|3191477|Superiority or Other||Mean Difference (Final Values)|-1.11||||0.718||95.0|-7.21|4.98||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733532|NCT00523991|3191479|Superiority or Other||Mean Difference (Final Values)|-5.88||||0.064||95.0|-12.1|0.35||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo|
1733533|NCT00523991|3191480|Superiority or Other||Mean Difference (Final Values)|-1.19||||0.72||95.0|-7.77|5.39||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733534|NCT00523991|3191481|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.995||95.0|-6.31|6.27||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733535|NCT00523991|3191482|Superiority or Other||Mean Difference (Final Values)|0.77||||0.754||95.0|-4.12|5.67||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733536|NCT00523991|3191483|Superiority or Other||Mean Difference (Final Values)|-1.03||||0.767||95.0|-7.86|5.81||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733537|NCT00523991|3191484|Superiority or Other||Mean Difference (Final Values)|-0.61||||0.823||95.0|-6.01|4.79||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733538|NCT00523991|3191486|Superiority or Other||Mean Difference (Final Values)|-3.76||||0.043||95.0|-7.39|-0.13||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo|
1733539|NCT00523991|3191487|Superiority or Other||Mean Difference (Final Values)|-0.79||||0.682||95.0|-4.6|3.01||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo|
1733540|NCT00523991|3191488|Superiority or Other||Mean Difference (Final Values)|-1.85||||0.313||95.0|-5.45|1.75||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo|
1733541|NCT00523991|3191489|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.763||95.0|-4.0|2.93||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733542|NCT00523991|3191490|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.149||95.0|-5.9|0.9||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo|
1733586|NCT00522548|3191696|Superiority|||||||0.012||||||This p value is for data at week 4. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study|
1733543|NCT00523991|3191491|Superiority or Other||Mean Difference (Final Values)|0.64||||0.729||95.0|-2.97|4.24||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms for treatment, site, and work productivity at baseline~Mean Difference (Final Values) means difference in LS Means"||tiotropium versus placebo|
1733544|NCT00523991|3191493|Superiority or Other|||||||0.086|||||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo|
1733545|NCT00523991|3191494|Superiority or Other|||||||0.01|||||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo|
1733546|NCT00523991|3191495|Superiority or Other|||||||0.223|||||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo|
1733547|NCT00523991|3191496|Superiority or Other|||||||0.045|||||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo|
1733548|NCT00523991|3191497|Superiority or Other|||||||0.186|||||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo|
1733549|NCT00523991|3191498|Superiority or Other|||||||0.174|||||||Cochran-Mantel-Haenszel|Site as stratum||tiotropium versus placebo|
1733550|NCT00523991|3191499|Superiority or Other||Mean Difference (Final Values)|0.02||||0.927||95.0|-0.38|0.41||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and albuterol use at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733551|NCT00523991|3191506|Superiority or Other||Mean Difference (Final Values)|0.35|||<|0.001||95.0|0.26|0.45||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733552|NCT00523991|3191507|Superiority or Other||Mean Difference (Final Values)|0.33|||<|0.001||95.0|0.25|0.4||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo|
1733553|NCT00523991|3191508|Superiority or Other||Mean Difference (Final Values)|0.3|||<|0.001||95.0|0.23|0.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo|
1733554|NCT00523991|3191509|Superiority or Other||Mean Difference (Final Values)|0.29|||<|0.001||95.0|0.21|0.36||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733555|NCT00523991|3191510|Superiority or Other||Mean Difference (Final Values)|0.21|||<|0.001||95.0|0.14|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo|
1733556|NCT00523991|3191526|Superiority or Other||Mean Difference (Final Values)|0.33|||<|0.001||95.0|0.24|0.42||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and peak forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733557|NCT00523991|3191530|Superiority or Other||Mean Difference (Final Values)|0.21|||<|0.001||95.0|0.14|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and trough forced vital capacity at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733558|NCT00523991|3191534|Superiority or Other||Mean Difference (Final Values)|0.31|||<|0.001||95.0|0.24|0.38||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|terms include treatment, site, and forced vital capacity area under the curve at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo|
1733559|NCT00523991|3191538|Superiority or Other||Mean Difference (Final Values)|0.25|||<|0.001||95.0|0.2|0.3||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and peak forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733560|NCT00523991|3191539|Superiority or Other||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.2|0.29||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733561|NCT00523991|3191540|Superiority or Other||Mean Difference (Final Values)|0.23|||<|0.001||95.0|0.18|0.28||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium vesus placebo|
1733562|NCT00523991|3191541|Superiority or Other||Mean Difference (Final Values)|0.2|||<|0.001||95.0|0.16|0.25||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733755|NCT00519584|3192070|Superiority|||||||0.005|||||||Wilcoxon (Mann-Whitney)||||
1733563|NCT00523991|3191542|Superiority or Other||Mean Difference (Final Values)|0.14|||<|0.001||95.0|0.09|0.18||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|"Terms include treatment, site, and forced expiratory volume in 1 second at baseline~Mean Difference (Final Values) means difference in LSMeans"||tiotropium versus placebo|
1733564|NCT00523991|3191558|Superiority or Other||Mean Difference (Final Values)|0.24|||<|0.001||95.0|0.19|0.29||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Terms include treatment, site, and peak forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo|
1733565|NCT00523991|3191562|Superiority or Other||Mean Difference (Final Values)|0.14|||<|0.001||95.0|0.09|0.18||All secondary analyses are exploratory and therefore no corrections for multiple hypotheses testing are made. The results have to be interpreted in a descriptive manner.|ANCOVA|Terms include treatment, site, and trough forced expiratory volume in 1 second at baseline Mean Difference (Final Values) means difference in LSMeans||tiotropium versus placebo|
1733566|NCT00523991|3191566|Superiority or Other||Mean Difference (Final Values)|0.23|||<|0.001||95.0|0.18|0.27||"There was only one primary endpoint and the p-value was not adjusted for multiple comparisons.~Mean Difference (Final Values) means difference in LS-Means"|ANCOVA|The analysis of covariance model included treatment, site, and trough forced expiratory volume in 1 second at baseline in the model.|||
1733567|NCT00523978|3191567|Superiority or Other||||||<|0.001|||||||Fisher Exact|||The test hypothesis is UCBExperimental_CPE ≥ 14.8% vs UCBExperimental_CPE < 14.8%.The performance goal 14.8% was chosen based on a review of SSEDs for similar types of ablation trials.The expected rate for CPEs in a well-monitored trial of left atrial RF ablation for AF was estimated to be 10% (corresponding to a CPE-free rate of 90%).In a trial with 160 subject, the resulting one-sided 95% upper confidence bound would be 14.8%.|
1733568|NCT00523978|3191568|Non-Inferiority or Equivalence|A non-inferiority margin was selected based on literature review.|||||<|0.001|||||||t-test, 1 sided|||The null hypothesis is the proportion of subjects free from MAFE in the experimental group is inferior to that in the control group using 10% non-inferiority margin.A sample size of 160 evaluable cryoablation and 80 control subjects (one-sided α = 0.05, 2:1 randomization) was required to provide 80% power assuming the rate of free from MAFE at 12 months 80.5 and 77% in experimental and control groups respectively .|
1733569|NCT00523978|3191569|Superiority or Other||||||<|0.0001|||||||Fisher Exact|||The null hypothesis is the success rate in experimental group is less than and equal to the one in control group. This comparison of the rates was performed using a 2-sided Fisher’s Exact. A sample size of 240(160 experimental and 80 control) is required to provide 80% power to detect the treatment difference using a 2-sided (alpha = 0.05)Fisher’s Exact Test of binomial proportions assuming the success rate was 40% for control and 60% for treatment.|
1733570|NCT00523718|3191593|Superiority or Other (legacy)|||||||0.24|||||||Chi-squared||||
1733571|NCT00523705|3191597|Superiority or Other||Mean Difference (Final Values)|3.57|Standard Error of the Mean|4.86||0.467|2-Sided||||||Regression, Linear||estimate of main effect of treatment in a linear mixed effects model.|Pilot data were examined at treatment endpoint for change from baseline. Statistical power was very low due to the small sample size.|
1733572|NCT00523640|3191600|Superiority or Other||Proportion responding|0.24|||||2-Sided|95.0|0.1|0.44|||||||
1733573|NCT00523614|3191601|Non-Inferiority or Equivalence|"Size of the study adapted to the use of DNG/EE in female fertile age. Market share of DNG/EE of 13% in Germany. Assuming that 30% of women in the fertile age range were current users of OCs, a prevalence of current use of DNG/EE of about 4% was estimated.~Based on these data the number of cases needed to exclude a twofold increased VTE risk was estimated at about 500-700 cases (based on four controls per case)."|Odds Ratio (OR)|0.89|||<|0.05||95.0|0.57|1.39|||Regression, Logistic|||Null hypothesis: OR ≥ 2 (VTE of DNG/EE vs. other low-dose COC)|
1733574|NCT00522951|3191685|Non-Inferiority or Equivalence|non-inferiority margin = -1|Mean Difference (Final Values)|0.21||||||95.0|0.02|0.41|||||Investigator (secondary analysis)|H02: μG2 – μPr ≤ -1|
1733575|NCT00522951|3191685|Non-Inferiority or Equivalence|non-inferiority margin = -1|Mean Difference (Final Values)|-0.3||||||95.0|-0.5|-0.1|||||Investigator (secondary analysis)|H01: μG1 – μPr ≤ -1|
1733576|NCT00522951|3191685|Non-Inferiority or Equivalence|non-inferiority margin = -1|Mean Difference (Final Values)|0.06||||||95.0|-0.23|0.36|||||Averaged blinded reader (primary analysis)|H02: μG2 – μPr ≤ -1|
1733577|NCT00522951|3191685|Non-Inferiority or Equivalence|non-inferiority margin = -1|Mean Difference (Final Values)|-0.58||||||95.0|-0.87|-0.29|||||Averaged blinded reader (primary analysis)|H01: μG1 – μPr ≤ -1|
1733578|NCT00522873|3191689|Superiority or Other||proportion|0.84|||||2-Sided|95.0|0.756|0.904||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea|
1733579|NCT00522873|3191689|Superiority or Other||proportion|0.789|||||2-Sided|95.0|0.743|0.83||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea|
1733580|NCT00522873|3191690|Superiority or Other||proportion|0.593|||||2-Sided|95.0|0.496|0.684||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea|
1733581|NCT00522873|3191690|Superiority or Other||proportion|0.687|||||2-Sided|95.0|0.637|0.734||||||exact 95% confidence intervall (Clopper-Pearson) for proportion of participants with amenorrhea|
1733582|NCT00522873|3191691|Superiority or Other||proportion|0.0|||||2-Sided|95.0|0.0|0.0119|||||The number of women who had a biopsy classified as 'hyperplasia or worse' was divided by the number of women with an evaluable biopsy (i.e. classified as 'normal' after 1 year of treatment or as 'hyperplasia or worse' at any time during the study).|Exact 95% confidence interval for proportion of participants with hyperplasia or worse at EoS|
1733583|NCT00522548|3191695|Superiority|||||||0.23||||||p value represents data for week 24. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study|
1733584|NCT00522548|3191695|Superiority|||||||0.27||||||p value represents data for week 4. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study|
1733587|NCT00522548|3191697|Superiority|||||||0.58||||||This represents p value for week 24 data. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in CellCept group and 20 in the Myfortic group) in this proof of concept study.|
1733588|NCT00522548|3191697|Superiority|||||||0.45||||||This represents p value for week 4 data. A p value of less than 0.05 was considered significant.|Kruskal-Wallis|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study|
1733589|NCT00522548|3191698|Superiority|||||||0.57||||||The p value was not adjusted for multiple comparisons. A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.|
1733590|NCT00522548|3191699|Superiority|||||||0.95||||||A p-value of less than 0.05 was considered statistically significant.|t-test, 2 sided|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study.|
1733591|NCT00522548|3191700|Superiority or Other|||||||0.51||||||A p-value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study|
1733592|NCT00522548|3191701|Superiority|||||||0.34||||||A p value of less than 0.05 was considered statistically significant.|Chi-squared|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study|
1733593|NCT00522548|3191702|Superiority|||||||0.14||||||a p value of less than 0.05 was considered statistically significant|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study|
1733594|NCT00522548|3191703|Superiority|||||||1||||||A p value of less than 0.05 was considered significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study|
1733595|NCT00522548|3191704|Superiority|||||||1||||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study|
1733596|NCT00522548|3191705|Superiority or Other|||||||0.39||||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study|
1733597|NCT00522548|3191706|Superiority|||||||0.29||||||A p value of less than 0.05 was considered statistically significant.|Fisher Exact|||Sample size was arbitrarily determined as 40 patients (20 in the CellCept group and 20 in the Myfortic group) in this proof of concept study|
1733598|NCT00522418|3191724|Superiority or Other|||||||0.26|||||||F-Test||||
1733599|NCT00522418|3191725|Superiority or Other|||||||0.03|||||||F-Test||||
1733600|NCT00522418|3191726|Superiority or Other|||||||0.28|||||||F-Test||||
1733601|NCT00522418|3191727|Superiority or Other|||||||0.17|||||||F-Test||||
1733602|NCT00522418|3191730|Superiority or Other|||||||0.17|||||||F-Test||||
1733603|NCT00522418|3191733|Superiority or Other|||||||0.01|||||||F Test||||
1733604|NCT00522392|3191735|Superiority or Other|||||||0.48|||||||Log Rank|||Stratified log-rank test was used to compare overall survival between the two arms.|
1733605|NCT00522392|3191736|Superiority or Other|||||||0.029|||||||Fisher Exact|||Fisher's exact test was used to compare the response rates between the two arms.|
1733606|NCT00522392|3191737|Superiority or Other|||||||0.092|||||||Log Rank|||Stratified log rank test was used to compare progression-free survival between the two arms.|
1733607|NCT00521599|3191776|Superiority or Other|||||||0.001|||||||ANOVA|||Week 8 End scores|
1733608|NCT00521599|3191776|Superiority or Other|||||||0.003|||||||ANOVA|||Week 8 End scores|
1733609|NCT00521599|3191776|Non-Inferiority or Equivalence|assume n=240 per group and standard deviation (STD) = 45 L/min for AM Peak Flow Rate at Week 8. If the two actives are the same, 95% CI of their mean difference has 90% probability to be completely within +/- 15 L/min.|Mean Difference (Net)|-1.62|Standard Deviation|37.0||0.654|2-Sided|95.0|-8.74|5.49|||ANOVA|||Week 8 End scores|
1733610|NCT00521586|3191795|Superiority or Other||Geometric Mean Ratio|0.9|||||2-Sided|95.0|0.74|1.09||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733611|NCT00521586|3191795|Superiority or Other||Geometric Mean Ratio|0.93|||||2-Sided|95.0|0.77|1.12||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733612|NCT00521586|3191795|Superiority or Other||Geometric Mean Ratio|0.93|||||2-Sided|95.0|0.8|1.08||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733613|NCT00521586|3191795|Superiority or Other||Geometric Mean Ratio|0.92|||||2-Sided|95.0|0.79|1.06||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733614|NCT00521586|3191795|Superiority or Other||Geometric Mean Ratio|0.95|||||2-Sided|95.0|0.81|1.11||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733615|NCT00521586|3191795|Superiority or Other||Geometric Mean Ratio|0.93|||||2-Sided|95.0|0.81|1.07||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733616|NCT00521586|3191795|Superiority or Other||Geometric Mean Ratio|0.97|||||2-Sided|95.0|0.85|1.11||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733617|NCT00521586|3191795|Superiority or Other||Geometric Mean Ratio|0.93|||||2-Sided|95.0|0.77|1.12||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733618|NCT00521586|3191795|Superiority or Other||Geometric Mean Ratio|1.01|||||2-Sided|95.0|0.84|1.22||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733619|NCT00521586|3191795|Superiority or Other||Geometric Mean Ratio|0.93|||||2-Sided|95.0|0.8|1.09||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733620|NCT00521586|3191795|Superiority or Other||Geometric Mean Ratio|1.03|||||2-Sided|95.0|0.88|1.21||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733621|NCT00521586|3191795|Superiority or Other||Geometric Mean Ratio|0.95|||||2-Sided|95.0|0.82|1.1||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733622|NCT00521586|3191795|Superiority or Other||Geometric Mean Ratio|1.01|||||2-Sided|95.0|0.87|1.18||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733623|NCT00521586|3191804|Superiority or Other||Geometric Mean Ratio|1.0|||||2-Sided|95.0|0.8|1.27||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733624|NCT00521586|3191804|Superiority or Other||Geometric Mean Ratio|1.1|||||2-Sided|95.0|0.85|1.31||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733625|NCT00521586|3191804|Superiority or Other||Geometric Mean Ratio|1.0|||||2-Sided|95.0|0.87|1.21||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733626|NCT00521586|3191804|Superiority or Other||Geometric Mean Ratio|1.0|||||2-Sided|95.0|0.84|1.27||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733627|NCT00521586|3191804|Superiority or Other||Geometric Mean Ratio|1.0|||||2-Sided|95.0|0.86|1.17||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733628|NCT00521586|3191804|Superiority or Other||Geometric Mean Ratio|1.2|||||2-Sided|95.0|0.93|1.48||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733629|NCT00521586|3191804|Superiority or Other||Geometric Mean Ratio|0.9|||||2-Sided|95.0|0.78|1.06||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733630|NCT00521586|3191804|Superiority or Other||Geometric Mean Ratio|1.0|||||2-Sided|95.0|0.84|1.21||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733631|NCT00521586|3191804|Superiority or Other||Geometric Mean Ratio|1.1|||||2-Sided|95.0|0.88|1.3||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733632|NCT00521586|3191804|Superiority or Other||Geometric Mean Ratio|0.9|||||2-Sided|95.0|0.68|1.08||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733633|NCT00521586|3191804|Superiority or Other||Geometric Mean Ratio|1.1|||||2-Sided|95.0|0.92|1.28||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733634|NCT00521586|3191804|Superiority or Other||Geometric Mean Ratio|0.9|||||2-Sided|95.0|0.75|1.08||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733756|NCT00519584|3192070|Superiority||||||<|0.001||||||adjusted significance level is 0.025|Wilcoxon (Mann-Whitney)||||
1733757|NCT00519584|3192071|Superiority||||||<|0.001|||||||Log Rank||||
1733635|NCT00521586|3191804|Superiority or Other||Geometric Mean Ratio|1.1|||||2-Sided|95.0|0.83|1.34||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733636|NCT00521586|3191805|Non-Inferiority or Equivalence|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.84|||||2-Sided|95.0|0.66|1.08||||||Serotype 23F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution|
1733637|NCT00521586|3191805|Non-Inferiority or Equivalence|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.86|||||2-Sided|95.0|0.67|1.1||||||Serotype 19F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution|
1733638|NCT00521586|3191805|Non-Inferiority or Equivalence|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.89|||||2-Sided|95.0|0.74|1.08||||||Serotype 19A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution|
1733639|NCT00521586|3191805|Non-Inferiority or Equivalence|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.72|||||2-Sided|95.0|0.58|0.88||||||Serotype 18C: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution|
1733640|NCT00521586|3191805|Non-Inferiority or Equivalence|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric Mean Ratio|0.77|||||2-Sided|95.0|0.6|0.98||||||Serotype 14: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution|
1733641|NCT00521586|3191805|Non-Inferiority or Equivalence|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.71|||||2-Sided|95.0|0.59|0.86||||||Serotype 9V: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution|
1733642|NCT00521586|3191805|Non-Inferiority or Equivalence|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.77|||||2-Sided|95.0|0.63|0.95||||||Serotype 7F: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733643|NCT00521586|3191805|Non-Inferiority or Equivalence|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.75|||||2-Sided|95.0|0.6|0.93||||||Serotype 6B: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733644|NCT00521586|3191805|Non-Inferiority or Equivalence|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.86|||||2-Sided|95.0|0.7|1.06||||||Serotype 6A: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733645|NCT00521586|3191805|Non-Inferiority or Equivalence|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.84|||||2-Sided|95.0|0.67|1.05||||||Serotype 5: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733646|NCT00521586|3191805|Non-Inferiority or Equivalence|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.69|||||2-Sided|95.0|0.55|0.87||||||Serotype 4: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733647|NCT00521586|3191805|Non-Inferiority or Equivalence|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.79|||||2-Sided|95.0|0.66|0.93||||||Serotype 3: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733648|NCT00521586|3191805|Non-Inferiority or Equivalence|Noninferiority was to be concluded if the lower limit of the 2-sided 95% CI for the GMR was greater than 0.5 (2-fold criterion).|Geometric mean ratio|0.74|||||2-Sided|95.0|0.58|0.95||||||Serotype 1: 2-sided 95 % CI for the ratio of 2 geometric means (13vPnC+TIV/Placebo and Placebo+TIV/13vPnC) was constructed by back transformation of the CIs for the difference of the 2 logarithmically transformed assay results computed using the Student t distribution.|
1733649|NCT00521586|3191806|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|0.3|||||2-Sided|95.0|-5.6|6.2||||||B strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.|
1733758|NCT00519584|3192071|Superiority||||||<|0.001|||||||Log Rank||||
1733650|NCT00521586|3191806|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|1.6|||||2-Sided|95.0|-3.9|7.2||||||A/H3N2 strain: Exact 2-sided, 95 % confidence intervals was computed based on the methodology by Chan and Zhang.|
1733651|NCT00521586|3191806|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower limit of the 2-sided 95% CI was greater than -0.1 or -10%|percent difference|2.8|||||2-Sided|95.0|-1.8|7.4||||||A/H1N1 strain: Exact 2-sided, 95 percent (%) confidence intervals was computed based on the methodology by Chan and Zhang|
1733652|NCT00521339|3191838|Superiority or Other (legacy)|||||||0.622|||||||Wilcoxon (Mann-Whitney)||||
1733653|NCT00521339|3191839|Superiority or Other (legacy)|||||||0.898|||||||Wilcoxon (Mann-Whitney)||||
1733654|NCT00521339|3191840|Superiority or Other (legacy)|||||||0.339|||||||Wilcoxon (Mann-Whitney)||||
1733655|NCT00521339|3191841|Superiority or Other (legacy)|||||||0.169|||||||Wilcoxon (Mann-Whitney)||||
1733656|NCT00521339|3191842|Superiority or Other (legacy)|||||||0.539|||||||Wilcoxon (Mann-Whitney)||||
1733657|NCT00521339|3191843|Superiority or Other (legacy)|||||||0.217|||||||Wilcoxon (Mann-Whitney)||||
1733658|NCT00521339|3191844|Superiority or Other (legacy)|||||||0.031|||||||Wilcoxon (Mann-Whitney)||||
1733659|NCT00521339|3191845|Superiority or Other (legacy)||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1733660|NCT00521339|3191846|Superiority or Other (legacy)|||||||0.018|||||||Wilcoxon (Mann-Whitney)||||
1733661|NCT00521339|3191847|Superiority or Other (legacy)|||||||0.018|||||||Wilcoxon (Mann-Whitney)||||
1733662|NCT00521339|3191848|Superiority or Other (legacy)|||||||0.015|||||||Wilcoxon (Mann-Whitney)||||
1733663|NCT00521339|3191849|Superiority or Other (legacy)|||||||0.014|||||||Wilcoxon (Mann-Whitney)||||
1733664|NCT00521339|3191851|Superiority or Other (legacy)|||||||0.039|||||||Wilcoxon (Mann-Whitney)||||
1733665|NCT00521339|3191852|Superiority or Other (legacy)|||||||0.031|||||||Wilcoxon (Mann-Whitney)||||
1733666|NCT00521339|3191853|Superiority or Other (legacy)|||||||0.008|||||||Wilcoxon (Mann-Whitney)||||
1733667|NCT00521339|3191855|Superiority or Other (legacy)|||||||0.13|||||||Wilcoxon (Mann-Whitney)||||
1733668|NCT00521339|3191856|Superiority or Other (legacy)|||||||0.329|||||||Wilcoxon (Mann-Whitney)||||
1733669|NCT00521339|3191857|Superiority or Other (legacy)|||||||0.242|||||||Wilcoxon (Mann-Whitney)||||
1733670|NCT00521339|3191858|Superiority or Other (legacy)|||||||0.632|||||||Wilcoxon (Mann-Whitney)||||
1733671|NCT00521339|3191859|Superiority or Other (legacy)|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1733672|NCT00521339|3191860|Superiority or Other (legacy)|||||||0.018|||||||Wilcoxon (Mann-Whitney)||||
1733673|NCT00521339|3191861|Superiority or Other (legacy)|||||||0.074|||||||Wilcoxon (Mann-Whitney)||||
1733674|NCT00521339|3191862|Superiority or Other (legacy)|||||||0.013|||||||Wilcoxon (Mann-Whitney)||||
1733675|NCT00520975|3191908|Superiority or Other||Hazard Ratio (HR)|1.09||||0.75|2-Sided|95.0|0.61|1.97|||Regression, Cox||||
1733676|NCT00520975|3191909|Superiority or Other||Hazard Ratio (HR)|0.73||||0.24|2-Sided|95.0|0.43|1.23|||Regression, Cox||||
1733677|NCT00520741|3191934|Superiority or Other||predicted exit rate at 112 days|0.323|||||2-Sided|95.0|0.268|0.378||||||The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.|
1733678|NCT00520741|3191936|Superiority or Other||Predicted exit rate at 112 days|0.3|||||2-Sided|95.0|0.246|0.355||||||The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the lower bound of the 95 % prediction interval for the historical-control of 0.653; hereafter referred to as the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.|
1733679|NCT00520676|3191938|Superiority or Other||Hazard Ratio (HR)|0.49|||<|0.001|2-Sided|95.0|0.35|0.66||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for unadjusted hazard ratio (HR) estimate.||
1733680|NCT00520676|3191939|Superiority or Other||Hazard Ratio (HR)|0.53|||<|0.001|2-Sided|95.0|0.4|0.71||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for unadjusted hazard ratio (HR) estimate.||
1733681|NCT00520676|3191940|Superiority or Other||Hazard Ratio (HR)|0.87||||0.641|2-Sided|95.0|0.49|1.55||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for hazard ratio (HR) estimate.||
1733682|NCT00520676|3191941|Superiority or Other||Odds Ratio (OR)|1.71||||0.081|2-Sided|95.0|0.93|3.15||The comparison of tumor response rates was conducted at a 2-sided significance level of 0.05.|Fisher Exact|Tumor response rate= # participants with a confirmed best response of CR or PR / # of participants who qualify for the analysis population.|Logistic regression model is used for odds ratio (OR) estimate.||
1733683|NCT00520676|3191942|Superiority or Other||Hazard Ratio (HR)|0.96||||0.8|2-Sided|95.0|0.72|1.29||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank|Cox regression model is used for hazard ratio (HR) estimate.|||
1733684|NCT00520676|3191943|Superiority or Other||Hazard Ratio (HR)|1.01||||0.934|2-Sided|95.0|0.72|1.42||The comparison was conducted at a 2-sided significance level of 0.05.|Log Rank||Cox regression model is used for hazard ratio (HR) estimate.||
1733685|NCT00520676|3191944|Superiority or Other||Hazard Ratio (HR)|0.45|||<|0.001|2-Sided|95.0|0.34|0.6||The comparison was conducted at a 1-sided significance level of 0.05.|Log Rank|Note that the 2-sided p-value for log rank is reported, which is <0.001, hence 1-sided p-value is <0.001.|Cox regression model is used for HR estimate.||
1733686|NCT00520546|3191950|Superiority or Other||accuracy|82.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733759|NCT00519584|3192072|Superiority||Hazard Ratio (HR)|0.44|||<|0.001|2-Sided|95.0|0.23|0.83|||Log Rank||bupivacaine/dex vs. bupivacaine/Saline||
1733687|NCT00520546|3191950|Superiority or Other||specificity|80.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733688|NCT00520546|3191950|Superiority or Other||sensitivity|83.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733689|NCT00520546|3191950|Superiority or Other||negative prediction|76.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733690|NCT00520546|3191950|Superiority or Other||positive prediction|86.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733691|NCT00520546|3191950|Superiority or Other||accuracy|54.0|||<|0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733692|NCT00520546|3191950|Superiority or Other||specificity|38.0|||<|0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733693|NCT00520546|3191950|Superiority or Other||sensitivity|66.0|||<|0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733694|NCT00520546|3191950|Superiority or Other||negative prediction|46.0|||<|0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733695|NCT00520546|3191950|Superiority or Other||positive prediction|59.0|||<|0.41||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733696|NCT00520546|3191950|Superiority or Other||accuracy|67.0|||<|0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733697|NCT00520546|3191950|Superiority or Other||specificity|43.0|||<|0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733698|NCT00520546|3191950|Superiority or Other||sensitivity|86.0|||<|0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733699|NCT00520546|3191950|Superiority or Other||negative prediction|69.0|||<|0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733700|NCT00520546|3191950|Superiority or Other||positive prediction|67.0|||<|0.002||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with malign lesions >5mm (n=98) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733701|NCT00520546|3191951|Superiority or Other||accuracy|88.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733702|NCT00520546|3191951|Superiority or Other||specificity|92.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733703|NCT00520546|3191951|Superiority or Other||sensitivity|87.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733704|NCT00520546|3191951|Superiority or Other||negative prediction|73.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733705|NCT00520546|3191951|Superiority or Other||positive prediction|96.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733706|NCT00520546|3191951|Superiority or Other||accuracy|60.0|||<|0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733707|NCT00520546|3191951|Superiority or Other||specificity|31.0|||<|0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733708|NCT00520546|3191951|Superiority or Other||sensitivity|73.0|||<|0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733709|NCT00520546|3191951|Superiority or Other||negative prediction|33.0|||<|0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733710|NCT00520546|3191951|Superiority or Other||positive prediction|71.0|||<|0.53||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733711|NCT00520546|3191951|Superiority or Other||accuracy|82.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733712|NCT00520546|3191951|Superiority or Other||specificity|84.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733713|NCT00520546|3191951|Superiority or Other||sensitivity|90.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733714|NCT00520546|3191951|Superiority or Other||negative prediction|73.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (n=38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733715|NCT00520546|3191951|Superiority or Other||positive prediction|84.0|||<|0.001||95.0|||||Fisher Exact|||"Lesion based analysis of FEC-PET, endorectal MRI and combined FEC-PET/eMRI in patients with Gleason Score >6 (n=43) as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733716|NCT00520546|3191952|Superiority or Other||accuracy|72.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733717|NCT00520546|3191952|Superiority or Other||specificity|82.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733718|NCT00520546|3191952|Superiority or Other||sensitivity|66.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733719|NCT00520546|3191952|Superiority or Other||negative prediction|57.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733720|NCT00520546|3191952|Superiority or Other||positive prediction|87.0|||<|0.001||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from PET/MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733721|NCT00520546|3191952|Superiority or Other||accuracy|45.0|||<|0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733722|NCT00520546|3191952|Superiority or Other||specificity|40.0|||<|0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733723|NCT00520546|3191952|Superiority or Other||sensitivity|48.0|||<|0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733724|NCT00520546|3191952|Superiority or Other||negative prediction|30.0|||<|0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733725|NCT00520546|3191952|Superiority or Other||positive prediction|60.0|||<|0.27||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from MRI as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733726|NCT00520546|3191952|Superiority or Other||accuracy|61.0|||<|0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733727|NCT00520546|3191952|Superiority or Other||specificity|42.0|||<|0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733728|NCT00520546|3191952|Superiority or Other||sensitivity|71.0|||<|0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733729|NCT00520546|3191952|Superiority or Other||negative prediction|44.0|||<|0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733730|NCT00520546|3191952|Superiority or Other||positive prediction|69.0|||<|0.09||95.0|||||Fisher Exact|||"lesion based (all lesions = 128) results from FEC-PET as compared with histological results on a lesion based analysis of all patients (38)~Null hypothesis: patient distribution in contingency table is incidental."|
1733731|NCT00520546|3191953|Superiority or Other||accuracy|95.0||||0.0043|2-Sided|95.0|82.0|99.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."|
1733732|NCT00520546|3191953|Superiority or Other||specificity|100.0||||0.0043|2-Sided|95.0|3.0|100.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."|
1733733|NCT00520546|3191953|Superiority or Other||sensitivity|95.0||||0.0043|2-Sided|95.0|82.0|99.0|||Fisher Exact|||"results from PET/MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."|
1733734|NCT00520546|3191953|Superiority or Other||accuracy|68.0|||<|0.0001|2-Sided|95.0|51.0|83.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."|
1733735|NCT00520546|3191953|Superiority or Other||specificity|0.0|||<|0.0001|2-Sided|95.0|0.0|98.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."|
1733736|NCT00520546|3191953|Superiority or Other||sensitivity|70.0|||<|0.0001|2-Sided|95.0|53.0|84.0|||Fisher Exact|||"results from MRI as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."|
1733737|NCT00520546|3191953|Superiority or Other||accuracy|95.0|||<|0.0526|2-Sided|95.0|82.0|99.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."|
1733738|NCT00520546|3191953|Superiority or Other||specificity|0.0|||<|0.0526|2-Sided|95.0|0.0|98.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."|
1733739|NCT00520546|3191953|Superiority or Other||sensitivity|97.0|||<|0.0526|2-Sided|95.0|86.0|100.0|||Fisher Exact|||"results from FEC-PET as compared with histological results on a patient based analysis~Null hypothesis: patient distribution in contingency table is incidental."|
1733740|NCT00520234|3192013|Superiority or Other|||||||0.14|||||||Cochran-Mantel-Haenszel|APACHE II Stratified|||
1733741|NCT00520039|3192032|Superiority or Other||Odds Ratio, log|0.25|Standard Error of the Mean|1.03||0.31|2-Sided|95.0|-0.78|1.28|||Chi-squared|df = 1|||
1733742|NCT00520039|3192033|Superiority or Other||Odds Ratio, log|0.31|Standard Error of the Mean|1.31||0.32|2-Sided|95.0|-1.0|1.62|||Chi-squared|df = 1|The odds of Resolution of MEE before OMT is represented in the denominator of the odds ratio||
1733743|NCT00520039|3192034|Superiority or Other||Odds Ratio, log|1.09|Standard Error of the Mean|0.94||0.02|2-Sided|95.0|0.15|2.03|||Chi-squared|df = 1|The denominator of the Odds ratio represents the odds of improvement for the Standard Care Only (SCO) group.|Test of the null hypothesis that there is no improvement in MEE at Visit 3 using tympanogram.|
1733744|NCT00519779|3192047|Superiority or Other||Mean Difference (Final Values)|0.012|Standard Error of the Mean|0.14||0.93|2-Sided|95.0|-0.26|0.29|||Mixed Models Analysis||||
1733745|NCT00519779|3192048|Superiority or Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.086||0.08|2-Sided|95.0|-0.33|0.018|||Mixed Models Analysis||||
1733746|NCT00519779|3192049|Superiority or Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.072||0.04|2-Sided|95.0|-0.3|-0.009|||Mixed Models Analysis||||
1733747|NCT00519779|3192050|Superiority or Other||Mean Difference (Final Values)|-0.076|Standard Error of the Mean|0.039||0.06|2-Sided|95.0|-0.15|0.002|||Mixed Models Analysis||||
1733748|NCT00519779|3192051|Superiority or Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.11||0.04|2-Sided|95.0|-0.44|-0.011|||Mixed Models Analysis||||
1733749|NCT00519779|3192052|Superiority or Other||Mean Difference (Final Values)|-0.0033|Standard Error of the Mean|0.09||0.97|2-Sided|95.0|-0.18|0.18|||Mixed Models Analysis|adjusted for baseline value, visit, gender, SAD|||
1733750|NCT00519636|3192064|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH): stratified approximate to Prescotts test; variation of chi-square test for treatment sequence/subjects no preference.|||
1733751|NCT00519636|3192065|Superiority or Other||Mean Difference (Net)|-0.6|Standard Error of the Mean|0.24||0.014||95.0|-1.1|-0.1|||ANCOVA||Mean Difference = Mean Change in FPNS - Mean Change in Placebo.|FPNS combined across treatment arms 1 (FPNS/FFNS) & 2 (Placebo FP/FF) compared with Placebo FPNS combined across treatment arms 1 (FPNS/FFNS)& 2 (Placebo FP/FF).|
1733752|NCT00519636|3192065|Superiority or Other||Mean Difference (Net)|-0.8|Standard Error of the Mean|0.24|<|0.001||95.0|-1.3|-0.3|||ANCOVA||Mean Difference = Mean Change in FFNS - Mean Change in Placebo.|FFNS combined across treatment arms 1 (FFNS/FPNS) & 2 (Placebo FF/FP) compared with Placebo FFNS combined across treatment arms 1 (FFNS/FPNS) & 2 (Placebo FF/FP).|
1733753|NCT00519584|3192069|Superiority|||||||0.15||||||adjusted significance level = 0.025|Wilcoxon (Mann-Whitney)||||
1733754|NCT00519584|3192069|Superiority|||||||0.29||||||adjusted significance level = 0.025|Wilcoxon (Mann-Whitney)||||
1733761|NCT00519428|3192079|Superiority or Other||Mean Difference (Final Values)|10.0|Standard Deviation|8.0||0.0916|2-Sided|95.0||||escitalopram + bupropion vs. escitalopram: F(1,159) = 1.93, ns escitalopram + bupropion vs. bupropion: F (1,157) = 1.99, ns|ANCOVA|adjusting for baseline score and country||To test the hypothesis that escitalopram + bupropion would have superior efficacy relative to each monotherapy, the group receiving both medications was separately compared to each monotherapy group, covarying for baseline score and country|
1733762|NCT00519428|3192081|Superiority|Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy).|Mean Difference (Final Values)|0.05|Standard Deviation|4.0||0.05|2-Sided|||||"Each individual test will require the calculated p to be < .0916 to declare that comparison to be significant. Since the hypothesis requires both comparisons to be significant, this produces an over-all alpha of .05."|Cochran-Mantel-Haenszel|||Hypothesis: Dual Treatment (escitalopram + bupropion) will result in greater improvement over 12 weeks than either monotherapy (i.e., two analyses: 1) dual treatment will outperform escitalopram monotherapy; 2) dual treatment will outperform bupropion monotherapy). Therefore each analysis will be done twice and it will be required that both analyses be significant to declare the over-all study significant.|
1733763|NCT00519285|3192115|Superiority or Other||Hazard Ratio (HR)|0.942||||0.3802|2-Sided|95.6|0.822|1.08||A priori threshold for statistical significance was set to 0.044 using the O'Brien-Fleming alpha spending function to account for two interim analyses.|Log Rank|Log rank test stratified on ECOG Performance Status|Hazard ratio (HR) aflibercept versus placebo estimated from a Cox proportional hazard model stratified on ECOG Performance Status|"Null hypothesis: No difference between aflibercept and placebo~The study was designed to provide 90% power to detect a 1.25-fold increase in median survival with aflibercept compared to placebo at a overall one-sided significance level of 0.025 with 873 deaths."|
1733764|NCT00518986|3192121|Superiority or Other|||||||0.0126|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733765|NCT00518986|3192122|Superiority or Other|||||||0.0096|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733766|NCT00518986|3192123|Superiority or Other|||||||0.0018|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733767|NCT00518986|3192124|Superiority or Other|||||||0.1627|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733768|NCT00518986|3192125|Superiority or Other|||||||0.1816|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733769|NCT00518986|3192126|Superiority or Other|||||||0.2428|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733770|NCT00518986|3192127|Superiority or Other|||||||0.1|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733771|NCT00518986|3192128|Superiority or Other|||||||0.1774|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733772|NCT00518986|3192129|Superiority or Other|||||||0.893|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733773|NCT00518986|3192130|Superiority or Other|||||||0.332|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733774|NCT00518986|3192131|Superiority or Other|||||||0.024||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with total score > 17.9|
1733775|NCT00518986|3192132|Superiority or Other|||||||0.0189||||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared|||Responders are defined as subjects who had a total score of > 17.9|
1733776|NCT00518986|3192133|Superiority or Other|||||||0.0027||||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with a total score > 17.9|
1733777|NCT00518986|3192134|Superiority or Other|||||||0.0854||||||P-value for treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as subjects with a total score of > 17.9|
1733778|NCT00518986|3192135|Superiority or Other|||||||0.01||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are defined as patients with a total score on FOSQ > 17.9|
1733779|NCT00518986|3192136|Superiority or Other|||||||0.0107|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733780|NCT00518986|3192137|Superiority or Other|||||||0.0296|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1734063|NCT00515502|3192720|Superiority or Other||Mean Difference (Final Values)|-5.23|Standard Error of the Mean|3.3802|||2-Sided|95.0|-11.96|1.504|||||||
1733781|NCT00518986|3192138|Superiority or Other|||||||0.0153|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733782|NCT00518986|3192139|Superiority or Other|||||||0.0679|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733783|NCT00518986|3192140|Superiority or Other|||||||0.0308|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733784|NCT00518986|3192141|Superiority or Other|||||||0.0129|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733785|NCT00518986|3192142|Superiority or Other|||||||0.0305|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733786|NCT00518986|3192143|Superiority or Other|||||||0.1245|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733787|NCT00518986|3192144|Superiority or Other|||||||0.0277|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733788|NCT00518986|3192145|Superiority or Other|||||||0.0879|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733789|NCT00518986|3192146|Superiority or Other|||||||0.3483||||||P-value for the treatment comparison is from the Pearson's chi-square test.|Chi-squared|||Responders are subjects with a worst fatigue score of < 7|
1733790|NCT00518986|3192147|Superiority or Other|||||||0.0118||||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders are subjects with worst fatigue score < 7|
1733791|NCT00518986|3192148|Superiority or Other|||||||0.6475||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders were patients with worst fatigue scores < 7|
1733792|NCT00518986|3192149|Superiority or Other|||||||0.0145||||||P-value for the treatment comparison is from Pearson's chi-square test|Chi-squared|||Responders were defined as subjects with worst fatigue score < 7|
1733793|NCT00518986|3192150|Superiority or Other|||||||0.3854||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared|||Responders are subjects with worst fatigue score < 7 after baseline|
1733794|NCT00518986|3192151|Superiority or Other|||||||0.0354|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733795|NCT00518986|3192152|Superiority or Other|||||||0.013|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733796|NCT00518986|3192153|Superiority or Other|||||||0.2888|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733797|NCT00518986|3192154|Superiority or Other|||||||0.0105|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733798|NCT00518986|3192155|Superiority or Other|||||||0.0754|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733799|NCT00518986|3192156|Superiority or Other|||||||0.0094|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733800|NCT00518986|3192157|Superiority or Other|||||||0.0349|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733801|NCT00518986|3192158|Superiority or Other|||||||0.1272|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733802|NCT00518986|3192159|Superiority or Other|||||||0.0289|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733803|NCT00518986|3192160|Superiority or Other|||||||0.0523|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733804|NCT00518986|3192161|Superiority or Other|||||||0.0105||||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared||||
1733805|NCT00518986|3192162|Superiority or Other|||||||0.0433||||||P-value for the treatment comparison is from a Pearson's chi-square test.|Chi-squared||||
1733806|NCT00518986|3192163|Superiority or Other|||||||0.0888||||||P-value for the treatment comparison is from a Pearson's chi-square test|Chi-squared||||
1733808|NCT00518986|3192165|Superiority or Other|||||||0.0025|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733809|NCT00518986|3192166|Superiority or Other|||||||0.0591|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733810|NCT00518986|3192167|Superiority or Other|||||||0.0355|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733811|NCT00518986|3192168|Superiority or Other|||||||0.1072|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group, and the p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline value as a covariate.|
1733812|NCT00518986|3192169|Superiority or Other|||||||0.0064|||||||Cochran-Mantel-Haenszel||||
1733813|NCT00518986|3192170|Superiority or Other|||||||0.0011|||||||Cochran-Mantel-Haenszel||||
1733814|NCT00518986|3192171|Superiority or Other|||||||0.0529||||||P-value was generated from a Cochran-Mantel-Haenszel chi-square test.|Cochran-Mantel-Haenszel||||
1733815|NCT00518986|3192172|Superiority or Other|||||||0.0207||||||P-value from Pearson's chi-square test|Chi-squared||||
1733816|NCT00518986|3192173|Superiority or Other|||||||0.0032||||||P-value from Pearson's chi-square test|Chi-squared||||
1733817|NCT00518986|3192174|Superiority or Other|||||||0.2017||||||P-value is from Pearson's chi-square test|Chi-squared||||
1733818|NCT00518986|3192175|Superiority or Other|||||||0.2196|||||||ANCOVA||||
1733819|NCT00518986|3192176|Superiority or Other|||||||0.3145|||||||ANCOVA||||
1733820|NCT00518986|3192177|Superiority or Other|||||||0.0019|||||||ANCOVA||||
1733821|NCT00518986|3192178|Superiority or Other|||||||0.0027||||||Nominal p-value is presented, but statistical significance cannot be claimed. As a key secondary variable significance could be claimed only if treatment effect was significant for both primary efficacy variables.|ANCOVA|||Least squares (LS) mean and standard error of the LS mean for each treatment group, and p-value for the treatment comparison is from an analysis of covariance (ANCOVA) with treatment as a factor and the baseline as covariate.|
1733822|NCT00518986|3192179|Superiority or Other|||||||0.012|||||||Chi-squared|P-value for comparison is from a Pearson's chi-square test||Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were <= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was > 0.05and the other was <=0.025, the variable with a p-value <= 0.025 was claimed as significant.|
1733823|NCT00518986|3192180|Superiority or Other|||||||0.3043|||||||ANCOVA|Study drug was fixed factor and corresponding baseline value was a covariate.||Since there were two primary outcome measures the Hochberg procedure was used to control overall Type 1 error rate at the 0.05 level. If both p-values for the primary variables were <= 0.05 the treatment was claimed to be significant for both variables. If 1 p-value was > 0.05and the other was <=0.025, the variable with a p-value <= 0.025 was claimed as significant.|
1733824|NCT00518973|3192181|Superiority|||||||0.9||||||t = .02|t-test, 2 sided|General Scale|||
1733825|NCT00518973|3192181|Superiority|||||||0.11||||||t=3.0|t-test, 2 sided|Negative Scale|||
1733826|NCT00518973|3192181|Superiority|||||||0.4||||||t = .78|t-test, 2 sided|Positive Scale|||
1733827|NCT00518973|3192182|Superiority|||||||0.83||||||t = .05|t-test, 2 sided||||
1733828|NCT00518973|3192183|Superiority|||||||0.77||||||t = .09|t-test, 2 sided|Reporting for State|||
1733829|NCT00518973|3192183|Superiority|||||||0.48||||||t = .52|t-test, 2 sided|Reporting for Trait|||
1733830|NCT00518973|3192184|Superiority|||||||0.72||||||t = .13|t-test, 2 sided||||
1733831|NCT00518973|3192185|Superiority|||||||0.4||||||t = .56|t-test, 2 sided|Hours of rituals|||
1733832|NCT00518973|3192185|Superiority|||||||0.15||||||t = 2.8|t-test, 2 sided|Hours occupied by preoccupations.|||
1733833|NCT00518882|3192188|Superiority or Other||Mean|-0.07|Standard Deviation|0.192|<|0.0001||95.0|-0.094|-0.038|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733834|NCT00518882|3192188|Superiority or Other||Mean|-0.08|Standard Deviation|0.176|<|0.0001||95.0|-0.105|-0.056|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733835|NCT00518882|3192189|Superiority or Other||Mean|-0.03|Standard Deviation|0.189||0.0344||95.0|-0.057|-0.002|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733836|NCT00518882|3192189|Superiority or Other||Mean|-0.02|Standard Deviation|0.168||0.1342||95.0|-0.041|0.006|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733837|NCT00518882|3192190|Superiority or Other||Estimated treatment difference, LS Mean|-0.02||||0.1119||95.0|-0.05|0.01||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1741653|NCT00432809|3203958|Superiority or Other||||||<|0.001|||||||ANOVA||||
1733838|NCT00518882|3192191|Superiority or Other||Mean|-0.07|Standard Deviation|0.302||0.0012||95.0|-0.118|-0.03|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733839|NCT00518882|3192191|Superiority or Other||Mean|-0.1|Standard Deviation|0.273|<|0.0001||95.0|-0.14|-0.062|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733840|NCT00518882|3192192|Superiority or Other||Mean|0.01|Standard Deviation|0.272||0.5499||95.0|-0.028|0.052|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733841|NCT00518882|3192192|Superiority or Other||Mean|0.06|Standard Deviation|0.269||0.0018||95.0|0.023|0.098|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733842|NCT00518882|3192193|Superiority or Other||Estimated treatment difference, LS Mean|-0.07||||0.0014||95.0|-0.11|-0.03||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1733843|NCT00518882|3192194|Superiority or Other||Mean|-0.1|Standard Deviation|1.47||0.2078||95.0|-0.35|0.08|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733844|NCT00518882|3192194|Superiority or Other||Mean|-0.3|Standard Deviation|1.07||0.0003||95.0|-0.43|-0.13|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733845|NCT00518882|3192195|Superiority or Other||Mean|0.0|Standard Deviation|0.96||0.7888||95.0|-0.16|0.12|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733846|NCT00518882|3192195|Superiority or Other||Mean|0.1|Standard Deviation|0.82||0.1161||95.0|-0.02|0.21|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733847|NCT00518882|3192196|Superiority or Other||Estimated treatment difference, LS Mean|-0.18||||0.0485||95.0|-0.37|0.0||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1733848|NCT00518882|3192197|Superiority or Other||Mean|-0.02|Standard Deviation|0.165||0.2244||95.0|-0.04|0.009|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733849|NCT00518882|3192197|Superiority or Other||Mean|-0.03|Standard Deviation|0.159||0.0254||95.0|-0.05|-0.003|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733850|NCT00518882|3192198|Superiority or Other||Mean|0.0|Standard Deviation|0.141||0.7923||95.0|-0.018|0.024|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733851|NCT00518882|3192198|Superiority or Other||Mean|-0.01|Standard Deviation|0.15||0.222||95.0|-0.034|0.008|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733852|NCT00518882|3192199|Superiority or Other||Estimated treatment difference, LS Mean|0.01||||0.5105||95.0|-0.02|0.04||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1733853|NCT00518882|3192200|Superiority or Other||Mean|0.31|Standard Deviation|0.346|<|0.0001||95.0|0.259|0.364|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733854|NCT00518882|3192200|Superiority or Other||Mean|0.27|Standard Deviation|0.306|<|0.0001||95.0|0.223|0.315|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733855|NCT00518882|3192201|Superiority or Other||Mean|0.03|Standard Deviation|0.307||0.1452||95.0|-0.012|0.079|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733856|NCT00518882|3192201|Superiority or Other||Mean|0.06|Standard Deviation|0.29||0.003||95.0|0.021|0.102|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733857|NCT00518882|3192202|Superiority or Other||Estimated treatment difference, LS Mean|-0.07||||0.0277||95.0|-0.13|-0.01||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1733858|NCT00518882|3192203|Superiority or Other||Mean|-0.21|Standard Deviation|0.647|<|0.0001||95.0|-0.303|-0.11|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733859|NCT00518882|3192203|Superiority or Other||Mean|-0.3|Standard Deviation|0.604|<|0.0001||95.0|-0.39|-0.214|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733860|NCT00518882|3192204|Superiority or Other||Mean|0.08|Standard Deviation|0.72||0.1281||95.0|-0.024|0.188|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733861|NCT00518882|3192204|Superiority or Other||Mean|0.03|Standard Deviation|0.606||0.4746||95.0|-0.054|0.115|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733862|NCT00518882|3192205|Superiority or Other||Estimated treatment difference, LS Mean|-0.04||||0.4412||95.0|-0.15|0.06||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1733863|NCT00518882|3192206|Superiority or Other||Mean|0.09|Standard Deviation|0.89||0.1911||95.0|-0.043|0.216|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733864|NCT00518882|3192206|Superiority or Other||Mean|-0.07|Standard Deviation|0.859||0.2764||95.0|-0.187|0.054|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733865|NCT00518882|3192207|Superiority or Other||Mean|0.12|Standard Deviation|0.804||0.0513||95.0|-0.001|0.233|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733866|NCT00518882|3192207|Superiority or Other||Mean|0.11|Standard Deviation|0.774||0.0513||95.0|-0.001|0.216|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733867|NCT00518882|3192208|Superiority or Other||Estimated treatment difference, LS Mean|-0.11||||0.0946||95.0|-0.23|0.02||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1733868|NCT00518882|3192209|Superiority or Other||Mean|11.13|Standard Deviation|87.145||0.092||95.0|-1.835|24.093|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733869|NCT00518882|3192209|Superiority or Other||Mean|24.86|Standard Deviation|59.326|<|0.0001||95.0|16.348|33.374|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733870|NCT00518882|3192210|Superiority or Other||Mean|2.49|Standard Deviation|52.997||0.5304||95.0|-5.327|10.307|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733871|NCT00518882|3192210|Superiority or Other||Mean|-18.18|Standard Deviation|62.811|<|0.0001||95.0|-26.988|-9.382|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733872|NCT00518882|3192211|Superiority or Other||Estimated treatment difference, LS Mean|29.37|||<|0.0001||95.0|16.81|41.93||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1733873|NCT00518882|3192212|Superiority or Other||Mean|-2.55|Standard Deviation|3.625|<|0.0001||95.0|-3.104|-1.997|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733874|NCT00518882|3192212|Superiority or Other||Mean|-2.21|Standard Deviation|3.752|<|0.0001||95.0|-2.747|-1.676|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733875|NCT00518882|3192213|Superiority or Other||Mean|-2.17|Standard Deviation|3.654|<|0.0001||95.0|-2.731|-1.618|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733876|NCT00518882|3192213|Superiority or Other||Mean|-1.93|Standard Deviation|3.703|<|0.0001||95.0|-2.457|-1.403|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733877|NCT00518882|3192214|Superiority or Other||Mean|-3.13|Standard Deviation|3.56|<|0.0001||95.0|-3.673|-2.589|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733878|NCT00518882|3192214|Superiority or Other||Mean|-3.31|Standard Deviation|3.857|<|0.0001||95.0|-3.861|-2.763|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733879|NCT00518882|3192215|Superiority or Other||Mean|0.58|Standard Deviation|3.114||0.0151||95.0|0.114|1.052|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733880|NCT00518882|3192215|Superiority or Other||Mean|0.32|Standard Deviation|2.705||0.1041||95.0|-0.066|0.706|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733881|NCT00518882|3192216|Superiority or Other||Mean|-0.09|Standard Deviation|2.989||0.6845||95.0|-0.541|0.356|||Paired t test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733882|NCT00518882|3192216|Superiority or Other||Mean|0.67|Standard Deviation|3.041||0.0026||95.0|0.238|1.106|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733883|NCT00518882|3192217|Superiority or Other||Mean|0.72|Standard Deviation|3.27||0.0042||95.0|0.23|1.212|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733884|NCT00518882|3192217|Superiority or Other||Mean|0.06|Standard Deviation|2.827||0.77||95.0|-0.344|0.463|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733885|NCT00518882|3192218|Superiority or Other||Estimated treatment difference, LS Mean|0.54||||0.038||95.0|0.03|1.05||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1734064|NCT00515502|3192720|Superiority or Other||Mean Difference (Final Values)|-2.336|Standard Error of the Mean|2.8164|||2-Sided|95.0|-7.952|3.28|||||||
1733886|NCT00518882|3192219|Superiority or Other||Estimated treatment difference, LS Mean|-0.39||||0.143||95.0|-0.91|0.13||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1733887|NCT00518882|3192220|Superiority or Other||Estimated treatment difference, LS Mean|0.73||||0.0124||95.0|0.16|1.31||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1733888|NCT00518882|3192221|Superiority or Other||Mean|-0.95|Standard Deviation|3.23||0.0002||95.0|-1.449|-0.459|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733889|NCT00518882|3192221|Superiority or Other||Mean|-0.35|Standard Deviation|3.975||0.229||95.0|-0.917|0.2211|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733890|NCT00518882|3192222|Superiority or Other||Mean|-0.37|Standard Deviation|3.838||0.2119||95.0|-0.956|0.214|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733891|NCT00518882|3192222|Superiority or Other||Mean|0.26|Standard Deviation|4.158||0.3859||95.0|-0.331|0.853|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733892|NCT00518882|3192223|Superiority or Other||Mean|-0.99|Standard Deviation|3.467||0.0003||95.0|-1.517|-0.458|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733893|NCT00518882|3192223|Superiority or Other||Mean|-1.08|Standard Deviation|3.662|<|0.0001||95.0|-1.605|-0.562|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733894|NCT00518882|3192224|Superiority or Other||Mean|1.07|Standard Deviation|3.775||0.0003||95.0|0.497|1.634|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733895|NCT00518882|3192224|Superiority or Other||Mean|0.22|Standard Deviation|3.053||0.3271||95.0|-0.219|0.654|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733896|NCT00518882|3192225|Superiority or Other||Mean|-0.09|Standard Deviation|3.419||0.7278||95.0|-0.604|0.423|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733897|NCT00518882|3192225|Superiority or Other||Mean|0.05|Standard Deviation|3.307||0.8396||95.0|-0.424|0.521|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733898|NCT00518882|3192226|Superiority or Other||Mean|1.15|Standard Deviation|3.253|<|0.0001||95.0|0.66|1.637|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733899|NCT00518882|3192226|Superiority or Other||Mean|-0.22|Standard Deviation|2.866|<|0.2972||95.0|-0.626|0.192|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733900|NCT00518882|3192227|Superiority or Other||LS Mean|1.01||||0.0005||95.0|0.44|1.57||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1733916|NCT00518882|3192239|Superiority or Other||Mean|0.25|Standard Deviation|0.803|<|0.0001||95.0|0.139|0.364|||Paired t-test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733901|NCT00518882|3192228|Superiority or Other||Estimated treatment difference, LS Mean|0.01||||0.9849||95.0|-0.52|0.53||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1733902|NCT00518882|3192229|Superiority or Other||Estimated treatment difference, LS Mean|1.33|||<|0.0001||95.0|0.8|1.86||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline value of the endpoint as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the endpoint in the liraglutide arm and exenatide arm, respectively.|
1733903|NCT00518882|3192230|Superiority or Other||Mean|-0.8|Standard Deviation|2.76|<|0.0001||95.0|-1.23|-0.42|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 – µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733904|NCT00518882|3192230|Superiority or Other||Mean|-1.3|Standard Deviation|2.5|<|0.0001||95.0|-1.62|-0.92|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78 – µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733905|NCT00518882|3192231|Superiority or Other||Mean|-0.1|Standard Deviation|2.42||0.4864||95.0|-0.48|0.23|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733906|NCT00518882|3192231|Superiority or Other||Mean|0.7|Standard Deviation|1.84|<|0.0001||95.0|0.48|1.0|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78– µ26=0 against HA: µ78 – µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733907|NCT00518882|3192232|Superiority or Other||Estimated treatment difference, LS Mean|-1.01|||<|0.0001||95.0|-1.37|-0.65||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline fasting plasma glucose as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the fasting plasma glucose in the liraglutide and exenatide arm, respectively.|
1733908|NCT00518882|3192233|Superiority or Other||Mean|-3.2|Standard Deviation|4.44|<|0.0001||95.0|-3.85|-2.55|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733909|NCT00518882|3192233|Superiority or Other||Mean|-3.3|Standard Deviation|4.63|<|0.0001||95.0|-3.9|-2.61|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 0 and 78 were constructed. H0 was µ78– µ0=0 against HA: µ78 – µ0 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733910|NCT00518882|3192234|Superiority or Other||Mean|-0.7|Standard Deviation|3.67||0.0075||95.0|-1.26|-0.2|||Paired t test|||A paired t test was made within the group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1733911|NCT00518882|3192234|Superiority or Other||Mean|-0.4|Standard Deviation|3.24||0.0793||95.0|-0.86|0.05|||Paired t test|||The analysis was made with a paired t test within the treatment group and 95% CIs for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26=0 against HA: µ78 – µ26 ≠ 0. A difference between the two means was concluded when H0 was rejected at the 5% level.|
1733912|NCT00518882|3192235|Superiority or Other||Estimated treatment difference, LS Mean|-0.38||||0.2235||95.0|-0.99|0.23||There were no multiplicity concerns.|ANCOVA|||ANCOVA model included treatment, country and previous treatment as fixed effects and baseline body weight as covariate. The objective was to demonstrate that treatment with liraglutide was different from treatment with exenatide. Thus the null hypothesis and its alternative were H0: µliraglutide = µexenatide against HA1:µliraglutide ≠ µexenatide where µliraglutide and µexenatide is the mean value of the body weight in the liraglutide arm and exenatide arm, respectively.|
1733913|NCT00518882|3192238|Superiority or Other||Mean|-0.85|Standard Deviation|1.105|<|0.0001||95.0|-1.01|-0.687|||Paired t-test|||The analysis was made with a paired t test within the exenatide→liraglutide group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 – µ0 = 0 against HA: µ78 – µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.|
1733914|NCT00518882|3192238|Superiority or Other||Mean|-0.98|Standard Deviation|1.119|<|0.0001||95.0|-1.137|-0.823|||Paired t-test|||The analysis was made with a paired t test within the treatment group and 95% confidence intervals for the difference between Weeks 0 and 78 were constructed. H0 was µ78 – µ0 = 0 against HA: µ78 – µ0 ≠ 0. A difference between the two means (Weeks 0 and 78) was concluded when H0 was rejected at the 5% level.|
1733915|NCT00518882|3192239|Superiority or Other||Mean|0.0|Standard Deviation|0.924||0.9872||95.0|-1.36|0.134|||Paired t-test|||A paired t test was made within the treatment group and 95% confidence intervals for the difference between Weeks 26 and 78 were constructed. H0 was µ78 – µ26 = 0 against HA: µ78 – µ26 ≠ 0. A difference between the two means (Week 26 and Week 78) was concluded when H0 was rejected at the 5% level.|
1734065|NCT00515502|3192720|Superiority or Other||Mean Difference (Final Values)|-1.121|Standard Error of the Mean|2.5993|||2-Sided|95.0|-6.308|4.067|||||||
1733917|NCT00518882|3192240|Non-Inferiority or Equivalence|Non-inferiority concluded if upper confidence interval of test is below 0.4%|Estimated treatment difference, LS Mean|-0.33|||<|0.0001||95.0|-0.47|-0.18||No multiplicity concerns|ANCOVA|||"ANCOVA with treatment, country and previous OAD treatment as fixed effects and baseline HbA1c as covariate.~2 hypotheses were tested: H01: µliraglutide ≥ µexenatide + Δ, HA1: µliraglutide < µexenatide + Δ; Δ=0.4%. If non-inferiority was concluded, a test for superiority was established by a 1-sided test of the hypothesis H02: µliraglutide ≥ µexenatide against HA2: µliraglutide < µexenatide. Superiority was concluded if the upper limit of the 2-sided 95% CI for the difference was below 0%."|
1733918|NCT00518713|3192241|Superiority or Other||||||<|0.0001|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733919|NCT00518713|3192241|Superiority or Other||||||<|0.0044|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733920|NCT00518713|3192241|Superiority or Other||||||<|0.0414|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733921|NCT00518713|3192242|Superiority or Other|||||||0.0924|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733922|NCT00518713|3192242|Superiority or Other|||||||0.2505|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733923|NCT00518713|3192242|Superiority or Other|||||||0.721|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733924|NCT00518713|3192249|Superiority or Other||||||<|0.0001|||||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733925|NCT00518713|3192249|Superiority or Other||||||<|0.001|||||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733926|NCT00518713|3192249|Superiority or Other||||||<|0.0279|||||||ANCOVA|||≥ 75% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733927|NCT00518713|3192249|Superiority or Other||||||<|0.0001|||||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733928|NCT00518713|3192249|Superiority or Other||||||<|0.0159|||||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733929|NCT00518713|3192249|Superiority or Other||||||<|0.3383|||||||ANCOVA|||≥ 50% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733930|NCT00518713|3192249|Superiority or Other||||||<|0.0004|||||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733931|NCT00518713|3192249|Superiority or Other||||||<|0.0026|||||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733932|NCT00518713|3192249|Superiority or Other||||||<|0.1324|||||||ANCOVA|||≥ 25% reduction. ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733933|NCT00518713|3192250|Superiority or Other|||||||0.0024|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733934|NCT00518713|3192250|Superiority or Other|||||||0.0161|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733935|NCT00518713|3192250|Superiority or Other|||||||0.1469|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733936|NCT00518713|3192251|Superiority or Other|||||||0.0025|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733937|NCT00518713|3192251|Superiority or Other|||||||0.2207|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1734066|NCT00515502|3192720|Superiority or Other||Mean Difference (Final Values)|2.585|Standard Error of the Mean|2.6352|||2-Sided|95.0|-2.671|7.84|||||||
1733938|NCT00518713|3192251|Superiority or Other|||||||0.1041|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733939|NCT00518713|3192252|Superiority or Other||||||<|0.0001|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733940|NCT00518713|3192252|Superiority or Other||||||<|0.0001|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733941|NCT00518713|3192252|Superiority or Other||||||<|0.0027|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733942|NCT00518713|3192253|Superiority or Other||||||<|0.0001|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733943|NCT00518713|3192253|Superiority or Other||||||<|0.0015|||||||ANCOVA|||ANCOVA with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733944|NCT00518713|3192253|Superiority or Other||||||<|0.012|||||||ANCOVA|||Analysis of covariance (ANCOVA) with the percent reduction in drop seizures as the dependent variable and treatment, pooled center, and baseline drop seizure rate as the independent variables. A step-down procedure used, starting with the high dose versus placebo.|
1733945|NCT00518687|3192254|Superiority or Other||Vaccine Efficacy (VE)|29.3||||0.032|2-Sided|95.0|-1.8|51.2||A 1-sided p-value <0.025 implies that the V710 vaccine efficacy is statistically significant|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo||
1733946|NCT00518687|3192255|Superiority or Other||Vaccine Efficacy (VE)|12.9||||0.347|2-Sided|95.0|-50.8|50.0||A 1-sided p-value <0.025 implies that the V710 vaccine efficacy is statistically significant|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo||
1733947|NCT00518687|3192256|Superiority or Other||Estimated rate difference|0.0||||0.997|2-Sided|95.0|-0.1|0.1|||Miettinen and Nurminen||||
1733948|NCT00518687|3192257|Superiority or Other||Vaccine Efficacy (VE)|18.5||||0.584|2-Sided|95.0|-48.6|55.8||A 1-sided p-value <0.025 implies that the V710 vaccine efficacy is statistically significantly greater than 20%|Exact 1-sided binomial test||VE = 1 - Relative Risk of V710 compared with placebo||
1733949|NCT00518622|3192258|Superiority or Other||Mean Difference (Net)|-2.46||||||95.0|-2.78|-2.13|||||Mean (Day 8 – baseline) HCV RNA for MK7009 600 mg qd minus mean (Day 8 – baseline) HCV RNA for placebo||
1733950|NCT00518622|3192258|Superiority or Other||Mean Difference (Net)|-1.93||||||95.0|-2.68|-1.18|||||Mean (Day 8 – baseline) HCV RNA for MK7009 125 mg qd minus mean (Day 8 – baseline) HCV RNA for placebo||
1733951|NCT00518622|3192258|Superiority or Other||Mean Difference (Net)|-4.73||||||95.0|-5.15|-4.31|||||Mean (Day 8 – baseline) HCV RNA for MK7009 700 mg bid minus mean (Day 8 – baseline) HCV RNA for placebo||
1733952|NCT00518622|3192258|Superiority or Other||Mean Difference (Net)|-3.38||||||95.0|-4.59|-2.17|||||Mean (Day 8 – baseline) HCV RNA for MK7009 500 mg bid minus mean (Day 8 – baseline) HCV RNA for placebo||
1733953|NCT00518622|3192258|Superiority or Other||Mean Difference (Net)|-2.9||||||95.0|-3.9|-1.9|||||Mean (Day 8 – baseline) HCV RNA for MK7009 250 mg bid minus mean (Day 8 – baseline) HCV RNA for placebo||
1733954|NCT00518622|3192258|Superiority or Other||Mean Difference (Net)|-2.64||||||95.0|-3.49|-1.8|||||Mean (Day 8 – baseline) HCV RNA for MK7009 75 mg bid minus mean (Day 8 – baseline) HCV RNA for placebo||
1733955|NCT00518622|3192258|Superiority or Other||Mean Difference (Net)|-2.01||||||95.0|-2.87|-1.14|||||Mean (Day 8 – baseline) HCV RNA for MK7009 25 mg bid minus mean (Day 8 – baseline) HCV RNA for placebo||
1733956|NCT00518531|3192272|Superiority or Other (legacy)||Risk Difference (RD)|27.4|||<|0.0001|2-Sided|95.0|18.1|36.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.||
1733957|NCT00518531|3192273|Superiority or Other (legacy)||Risk Difference (RD)|9.8||||0.0291|2-Sided|95.0|1.1|18.5|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.||
1733958|NCT00518531|3192274|Superiority or Other (legacy)||Risk Difference (RD)|27.7|||<|0.0001|2-Sided|95.0|17.6|37.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.||
1733959|NCT00518531|3192275|Superiority or Other (legacy)||Risk Difference (RD)|11.0||||0.0138|2-Sided|95.0|2.2|19.7|||Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture.|Positive values for absolute risk reduction favor denosumab.||
1733960|NCT00518531|3192276|Superiority or Other (legacy)||Risk Difference (RD)|30.9|||<|0.0001|2-Sided|95.0|20.6|41.3||All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture|Positive values for absolute risk reduction favor denosumab.||
1733961|NCT00518531|3192277|Superiority or Other (legacy)||Risk Difference (RD)|10.5||||0.0259|2-Sided|95.0|1.3|19.7||All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.|Cochran-Mantel-Haenszel|Stratified by center and prior osteoporotic fracture|Positive values for absolute risk reduction favor denosumab.||
1733962|NCT00518323|3192358|Superiority or Other||Mean Difference (Final Values)|-2.4|Standard Error of the Mean|4.34||0.574||95.0|-11.0|6.11||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|||
1734067|NCT00515502|3192720|Superiority or Other||Mean Difference (Final Values)|-2.645|Standard Error of the Mean|2.5254|||2-Sided|95.0|-7.687|2.396|||||||
1741654|NCT00432809|3203958|Superiority or Other||||||<|0.001|||||||ANOVA||||
1733963|NCT00518323|3192358|Superiority or Other||Mean Difference (Final Values)|-6.7|Standard Error of the Mean|4.28||0.119||95.0|-15.15|1.74||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|||
1733964|NCT00518323|3192358|Superiority or Other||Mean Difference (Final Values)|-4.9|Standard Error of the Mean|4.15||0.237||95.0|-13.11|3.26||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|||
1733965|NCT00518323|3192359|Superiority or Other||Mean Difference (Final Values)|13.5|Standard Error of the Mean|4.43||0.003||95.0|4.76|22.23||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|||
1733966|NCT00518323|3192359|Superiority or Other||Mean Difference (Final Values)|16.8|Standard Error of the Mean|4.4|<|0.001||95.0|8.08|25.43||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|||
1733967|NCT00518323|3192359|Superiority or Other||Mean Difference (Final Values)|8.1|Standard Error of the Mean|4.27|<|0.058||95.0|-0.29|16.56||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|||
1733968|NCT00518323|3192360|Superiority or Other||Mean Difference (Final Values)|4.0|Standard Error of the Mean|2.18||0.067||95.0|-0.28|8.33||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|||
1733969|NCT00518323|3192360|Superiority or Other||Mean Difference (Final Values)|8.6|Standard Error of the Mean|2.17|<|0.001||95.0|4.28|12.82||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|||
1733970|NCT00518323|3192360|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|2.1|<|0.846||95.0|-4.54|3.73||Comparison with placebo was without multiplicity adjustment.|ANCOVA|Used ANCOVA model with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|||
1733971|NCT00518323|3192361|Superiority or Other|||||||0.021||||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.|
1733972|NCT00518323|3192361|Superiority or Other||||||<|0.001||||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.|
1733973|NCT00518323|3192361|Superiority or Other||||||<|0.968||||||Comparison with placebo was without multiplicity adjustment.|ANCOVA|||Analysis of the change in the CGI-S score at end point was performed using an analysis of covariance model on the ranks of the change in score at end point with treatment (placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors, and (non-ranked) baseline CGI-S score as a covariate.|
1733974|NCT00518323|3192362|Superiority or Other||Mean Difference (Final Values)|-6.6|Standard Error of the Mean|3.29||0.086||95.0|-13.07|-0.09||The p value was associated with the closed testing procedure using Dunnett’s test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.|
1733975|NCT00518323|3192362|Superiority or Other||Mean Difference (Final Values)|-10.1|Standard Error of the Mean|3.27||0.006||95.0|-16.58|-3.67||The p value was associated with the closed testing procedure using Dunnett’s test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.|
1733976|NCT00518323|3192362|Superiority or Other||Mean Difference (Final Values)|-2.1|Standard Error of the Mean|3.17||0.508||95.0|-8.36|4.16||The p value was associated with the closed testing procedure using Dunnett’s test.|ANCOVA|Used ANCOVA model with treatment(placebo, pali ER Low, pali ER Medium, and pali ER High) and country as factors and baseline value as a covariate.|The 95% confidence intervals were unadjusted for multiplicity.|If there were approximately 49 subjects per treatment group who had Week 6 (LOCF or end point) PANSS total measurements, the study was expected to have approximately 80% power to detect a clinically relevant difference of 13.2 points between any paliperidone ER group compared with placebo for the primary outcome measure.|
1733977|NCT00518180|3192382|Non-Inferiority or Equivalence|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was > 0.67.|Vaccine Group Ratio|0.67|||||2-Sided|95.0|0.58|0.76||||||Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alon, for FHA antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.|
1734068|NCT00515502|3192720|Superiority or Other||Mean Difference (Final Values)|0.248|Standard Error of the Mean|1.9457|||2-Sided|95.0|-3.647|4.144|||||||
1734427|NCT00511004|3193367|Superiority or Other||||||<|0.2||||||Adjusted for multiple comparisons|Fisher Exact||||
1733978|NCT00518180|3192382|Non-Inferiority or Equivalence|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was > 0.67.|Vaccine Group Ratio|0.68|||||2-Sided|95.0|0.58|0.81||||||Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PRN antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.|
1733979|NCT00518180|3192382|Non-Inferiority or Equivalence|Tdap concomitant with MenACWY a was considered non inferior to Tdap alone if, for PT, FHA and pertactin, the lower limit of the two-sided 95% CI for the ratio of the GMCs (GMC Group I / GMC Group III) at 1 month after vaccination was > 0.67.|Vaccine Group Ratio|0.8|||||2-Sided|95.0|0.72|0.9||||||Non inferiority of the immune response to Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, for PT antigen. Method: ANCOVA. Parameter estimate: Vaccine Group Ratio.|
1733980|NCT00518180|3192391|Non-Inferiority or Equivalence|Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, was demonstrated for the diphteria and tetanus antigens if the lower limits of the two-sided 95% CIs around the difference in the percentages of subjects with ELISA anti-D toxin ≥ 1.0 IU/mL [Group I minus Group III] were greater than -10%.|Vaccine Group differences (%)|0.0|||||2-Sided|95.0|-1.0|1.0||||||Non inferiority of the immune response to tetanus antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.|
1733981|NCT00518180|3192391|Non-Inferiority or Equivalence|Non inferiority of the immune response to Tdap when administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone, was demonstrated for the diphteria and tetanus antigens if the lower limits of the two-sided 95% CIs around the difference in the percentages of subjects with ELISA anti-D toxin ≥ 1.0 IU/mL [Group I minus Group III] were greater than -10%.|Vaccine Group differences (%)|2.0|||||2-Sided|95.0|1.0|4.0||||||Non inferiority of the immune response to diphteria antigen, when Tdap is administered concomitantly with MenACWY and HPV, compared with the immune response to Tdap when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.|
1733982|NCT00518180|3192392|Non-Inferiority or Equivalence|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-4.0|||||2-Sided|95.0|-9.0|1.0||||||Immune response to Men Y when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.|
1733983|NCT00518180|3192392|Non-Inferiority or Equivalence|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-16.0|||||2-Sided|95.0|-21.0|-10.0||||||Immune response to Men W when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.|
1733984|NCT00518180|3192392|Non-Inferiority or Equivalence|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-1.0|||||2-Sided|95.0|-6.0|4.0||||||Immune response to Men C when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.|
1733985|NCT00518180|3192392|Non-Inferiority or Equivalence|The immunogenicity of MenACWY given after Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup III minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|5.0|||||2-Sided|95.0|1.0|10.0||||||Immune response to Men A when MenACWY is administered 1 month after Tdap, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.|
1733986|NCT00518180|3192392|Non-Inferiority or Equivalence|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|0.0|||||2-Sided|95.0|-4.0|5.0||||||Immune response to Men Y when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.|
1733987|NCT00518180|3192392|Non-Inferiority or Equivalence|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-4.0|||||2-Sided|95.0|-9.0|1.0||||||Immune response to Men W when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.|
1734025|NCT00516321|3192618|Superiority or Other||Percentage difference in SVR|7.9||||0.0064|2-Sided|95.0|2.4|13.4||Stratified Cochran-Mantel-Haenszel (CMH) chi-square test adjusted for the randomization strata|Cochran-Mantel-Haenszel||The estimated value reflects the percentage of participants with SVR in the eltrombopag group minus the percentage of participants with SVR in the placebo group. Adjusted for the actual strata: HCV genotype, baseline platelet count, and HCV RNA.||
1734069|NCT00515502|3192720|Superiority or Other||Mean Difference (Final Values)|1.464|Standard Error of the Mean|1.9766|||2-Sided|95.0|-2.492|5.419|||||||
1733988|NCT00518180|3192392|Non-Inferiority or Equivalence|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-1.0|||||2-Sided|95.0|-6.0|3.0||||||Immune response to Men C when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.|
1733989|NCT00518180|3192392|Non-Inferiority or Equivalence|The immunogenicity of MenACWY given concomitantly with HPV and Tdap was considered non inferior to the immunogenicity of MenACWY administered alone, if, for each serogroup, the lower limit of the two-sided 95% confidence interval (CI) for the difference in percentage of subjects with seroresponse at one month after MenACWY vaccination (PGroup I minus PGroup II) was greater than -10%.|Vaccine Group differences (%)|-2.0|||||2-Sided|95.0|-6.0|3.0||||||Immune response to Men A when MenACWY is administered concomitantly with Tdap and HPV, compared with the immune response to MenACWY when administered alone. Method: ANCOVA. Parameter estimate: Vaccine Group Differences.|
1733990|NCT00518115|3192411|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.0022|2-Sided|95.0|-0.99|-0.22|||ANCOVA||||
1733991|NCT00518115|3192411|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.0786|2-Sided|95.0|-0.72|0.04|||ANCOVA||||
1733992|NCT00518115|3192411|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.0032|2-Sided|95.0|-0.96|-0.19|||ANCOVA||||
1733993|NCT00518115|3192411|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.0057|2-Sided|95.0|-0.94|-0.16|||ANCOVA||||
1733994|NCT00518115|3192411|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.2766|2-Sided|95.0|-0.62|0.18|||ANCOVA||||
1733995|NCT00518115|3192411|Superiority or Other||Mean Difference (Final Values)|-0.62||||0.0027|2-Sided|95.0|-1.03|-0.22|||ANCOVA||||
1733996|NCT00518115|3192411|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.186|2-Sided|95.0|-0.64|0.12|||ANCOVA||||
1733997|NCT00518115|3192411|Superiority or Other||Mean Difference (Final Values)|0.2||||0.2968|2-Sided|95.0|-0.18|0.59|||ANCOVA||||
1733998|NCT00518011|3192420|Superiority or Other||Hazard Ratio (HR)|1.278||||0.7165|2-Sided|95.0|0.339|4.824|||Log Rank||||
1733999|NCT00518011|3192424|Superiority or Other||Hazard Ratio (HR)|1.842||||0.3644|2-Sided|95.0|0.483|7.027|||Log Rank||||
1734000|NCT00517933|3192426|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.86|2-Sided|95.0|-2.1|1.7|||Regression, Linear||||
1734001|NCT00517933|3192428|Superiority or Other||Mean Difference (Final Values)|2.9||||0.008|2-Sided|95.0|0.8|5.0|||Regression, Linear||||
1734002|NCT00517933|3192432|Superiority or Other||Mean Difference (Final Values)|2.3||||0.37|2-Sided|95.0|-2.8|7.3|||Regression, Linear||||
1734003|NCT00517933|3192434|Superiority or Other||Mean Difference (Final Values)|0.02||||0.18|2-Sided|95.0|-0.01|0.06|||Regression, Linear||||
1734004|NCT00517933|3192436|Superiority or Other||Mean Difference (Final Values)|-3.7||||0.07|2-Sided|95.0|-7.8|0.4|||Regression, Logistic||||
1734005|NCT00517933|3192438|Superiority or Other||Mean Difference (Final Values)|-3.6||||0.04|2-Sided|95.0|-7.2|-0.1|||Regression, Linear||||
1734006|NCT00517933|3192440|Superiority or Other||Mean Difference (Final Values)|-5.7||||0.02|2-Sided|95.0|-10.6|-0.9|||Regression, Linear||||
1734007|NCT00517933|3192442|Superiority or Other||Mean Difference (Final Values)|-4.1||||0.01|2-Sided|95.0|-7.3|-0.9|||Regression, Linear||||
1734008|NCT00517933|3192444|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.16|2-Sided|95.0|-0.81|0.14|||Regression, Linear||||
1734009|NCT00517933|3192446|Superiority or Other||Mean Difference (Final Values)|1.6||||0.04|2-Sided|95.0|0.1|3.0|||Mixed Models Analysis||||
1734010|NCT00517933|3192448|Superiority or Other||Mean Difference (Final Values)|0.01||||0.7|2-Sided|95.0|-0.05|0.07|||Mixed Models Analysis||||
1734011|NCT00517933|3192450|Superiority or Other||Slope|-6.58|Standard Error of the Mean|2.3||0.006|2-Sided|95.0|-11.25|-1.92|||Mixed Models Analysis||||
1734012|NCT00517933|3192451|Superiority or Other|||||||0.41|||||||Log Rank||||
1734013|NCT00517933|3192452|Superiority or Other||Mean Difference (Final Values)|16.7||||0.11|2-Sided|95.0|-3.9|37.3|||Regression, Linear||||
1734014|NCT00517933|3192454|Superiority or Other|||||||0.39|||||||Chi-squared||||
1734015|NCT00517595|3192496|Superiority or Other|||||||0.0041|||||||Log Rank|||Within Group 1 (N=48), patients with an ECOG of 0 at baseline (N=18) were compared to patients with an ECOG of 1 at baseline (N=30).|
1734016|NCT00517595|3192497|Superiority or Other|||||||0.02|||||||Log Rank|||Within Group 1 (N=48), patients with an ECOG of 0 at baseline (N=18) were compared to patients with an ECOG of 1 at baseline (N=30).|
1734017|NCT00517556|3192502|Superiority|||||||0.05|||||||Mixed Models Analysis||||
1734018|NCT00516919|3192572|Superiority or Other (legacy)||F statistic|0.69|||=|0||95.0|||||ANCOVA|Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)||Test for group differences in BMI at 6-month follow-up, controlling for baseline BMI.|
1734019|NCT00516919|3192572|Superiority or Other (legacy)||F statistic|0.45|||=|0||95.0|||||ANCOVA|Covariate = Baseline (pre-treatment) BMI; Degrees of freedom = (1, 76)||Test for group differences in BMI at post-treatment, controlling for baseline BMI.|
1734020|NCT00516503|3192591|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1734021|NCT00516503|3192592|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1734022|NCT00516503|3192593|Superiority or Other|||||||0.9|||||||Wilcoxon (Mann-Whitney)||||
1734023|NCT00516386|3192594|Superiority or Other||Mean Difference (Final Values)|39.3|Standard Error of the Mean|9.3|<|0.05||95.0|||||Paired t-test|||We used a paired t-test to determine the change in P1NP from baseline to 7-10 days following administration of rhIGF-1|
1734024|NCT00516386|3192595|Superiority or Other||Mean Difference (Net)|543.0|Standard Error of the Mean|41.0|<|0.05|||||||Paired t-test|||We used paired t-tests to assess changes in levels of IGF-1 from baseline levels in girls with AN receiving rhIGF-1. Our hypothesis was that rhIGF-1 administration would be associated with a significant increase in IGF-1 levels.|
1734026|NCT00516269|3192621|Superiority or Other||mean difference in treat versus control|0.42|Standard Deviation|3.3||0.54||95.0|||||Wilcoxon signed rank test|||As a crossover study, the potential carryover effect was examined first. The pooled data (the 2-week treatment for each intervention i.e. period 1 & period 2) was used to assess the treatment effect (A versus B).|
1734027|NCT00516165|3192625|Superiority or Other|||||||0.05|||||||Kaplan-Meier||||
1734028|NCT00516165|3192626|Superiority or Other|||||||0.05|||||||Kaplan-Meier||||
1734029|NCT00516165|3192627|Superiority or Other|||||||0.05|||||||Kaplan-Meier||||
1734030|NCT00516165|3192628|Superiority or Other||||||<|0.05|||||||Kaplan-Meier||||
1734031|NCT00516165|3192629|Superiority or Other||||||<|0.05|||||||Kaplan-Meier||||
1734032|NCT00516165|3192630|Superiority or Other|||||||0.05|||||||Kaplan Meier||||
1734033|NCT00516074|3192653|Non-Inferiority or Equivalence|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.26|||||||ANCOVA||||
1734034|NCT00516074|3192654|Non-Inferiority or Equivalence|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.427|||||||ANCOVA||||
1734035|NCT00516074|3192655|Non-Inferiority or Equivalence|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.9034|||||||ANCOVA||||
1734036|NCT00516074|3192656|Non-Inferiority or Equivalence|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.5077|||||||ANCOVA||||
1734037|NCT00516074|3192657|Non-Inferiority or Equivalence|Power calculation for the primary endpoint is described as part of the primary endpoint information above.||||||0.1624|||||||ANCOVA||||
1734038|NCT00516074|3192658|Non-Inferiority or Equivalence|Approximately 25 subjects were intended to be randomized to both the exenatide and placebo arms. Assuming an approximate 24% dropout rate, 19 patients per treatment arm would complete the study. A sample of 19 patients per treatment group would provide 90% power to detect a 10 bpm difference between treatment groups in change in daily mean heart rate from baseline.||||||0.1585|||||||ANCOVA||||
1734039|NCT00515827|3192676|Superiority or Other|||||||0.546||||||P-value is 2-sided and is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)||||
1734040|NCT00515723|3192677|Superiority|||||||0.22||||||The a priori threshold for statistical significance in this planned primary test was p<0.05.|Mixed Models Analysis|||Primary analysis for change in insulin sensitivity used a likelihood-based mixed-effects model using time (0 and 12 weeks) and treatment group as the independent variables, with an unstructured covariance structure specified, based on the Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there were no differences between groups in the change over time (time by treatment condition).|
1734041|NCT00515723|3192677|Superiority|||||||0.05||||||The a priori threshold for statistical significance in this planned primary test was p<0.05.|Mixed Models Analysis|||Primary analysis for change in insulin sensitivity used a likelihood-based mixed-effects model using time (0 and 12 weeks) as the independent variable, with an unstructured covariance structure specified, based on the Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there was no difference in the outcome over time (main effect of time).|
1734042|NCT00515723|3192678|Superiority|||||||0.002||||||The a priori threshold for statistical significance in this planned primary test was p<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA total fat used a likelihood-based mixed-effects model using time (0, 6, and 12 weeks) and treatment group as independent variables, with Toeplitz covariance structure specified, based on Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there were no differences between groups in the change over time (time by treatment condition).|
1734043|NCT00515723|3192678|Superiority|||||||0.002||||||The a priori threshold for statistical significance in this planned primary test was p<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA total fat used a likelihood-based mixed-effects model using time (0, 6, and 12 weeks) as the independent variable, with Toeplitz covariance structure specified, based on Akaike Information Criterion-Corrected (AIC-C). The null hypothesis was that there was no difference in the outcome over time (main effect of time).|
1734044|NCT00515671|3192687|Superiority or Other|||||||0.3328|||||||Mixed Models Analysis||||
1734045|NCT00515671|3192688|Superiority or Other|||||||0.8868|||||||Mixed Models Analysis||||
1734046|NCT00515541|3192694|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The median of Groups A, B, and C grouped together was compared Baseline to Week 12.|
1734047|NCT00515541|3192694|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The median of Groups A, B, and C grouped together was compared Baseline to Week 6.|
1734048|NCT00515541|3192695|Superiority or Other|||||||0.01||||||A P-value <0.05 when compared to baseline is considered significant.|Wilcoxon (Mann-Whitney)|||Group B baseline vs. Group B Week 12|
1734049|NCT00515502|3192718|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|1.74|||2-Sided|95.0|-4.1|2.9|||||||
1734050|NCT00515502|3192718|Superiority or Other||Mean Difference (Final Values)|0.7|Standard Error of the Mean|1.37|||2-Sided|95.0|-2.0|3.4|||||||
1734051|NCT00515502|3192718|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|1.26|||2-Sided|95.0|-3.3|1.7|||||||
1734052|NCT00515502|3192718|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|1.3|||2-Sided|95.0|-3.6|1.6|||||||
1734053|NCT00515502|3192718|Superiority or Other||Mean Difference (Final Values)|-1.6|Standard Error of the Mean|1.17|||2-Sided|95.0|-3.9|0.8|||||||
1734054|NCT00515502|3192718|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.86|||2-Sided|95.0|-2.0|1.4|||||||
1734055|NCT00515502|3192718|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|0.9|||2-Sided|95.0|-3.6|0.0|||||||
1734056|NCT00515502|3192719|Superiority or Other||Mean Difference (Final Values)|-2.4|Standard Error of the Mean|4.29|||2-Sided|95.0|-10.9|6.2|||||||
1734057|NCT00515502|3192719|Superiority or Other||Mean Difference (Final Values)|0.7|Standard Error of the Mean|3.38|||2-Sided|95.0|-6.1|7.5|||||||
1734058|NCT00515502|3192719|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|3.12|||2-Sided|95.0|-6.1|6.4|||||||
1741655|NCT00432809|3203959|Superiority or Other|||||||0.61|||||||ANOVA||||
1734070|NCT00515502|3192721|Superiority or Other||Mean Difference (Final Values)|-0.83|Standard Error of the Mean|4.087|||2-Sided|95.0|-8.97|7.32|||||||
1734071|NCT00515502|3192721|Superiority or Other||Mean Difference (Final Values)|1.67|Standard Error of the Mean|3.516|||2-Sided|95.0|-5.34|8.67|||||||
1734072|NCT00515502|3192721|Superiority or Other||Mean Difference (Final Values)|0.41|Standard Error of the Mean|3.279|||2-Sided|95.0|-6.13|6.94|||||||
1734073|NCT00515502|3192721|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|3.296|||2-Sided|95.0|-6.89|6.24|||||||
1734074|NCT00515502|3192721|Superiority or Other||Mean Difference (Final Values)|-1.15|Standard Error of the Mean|3.182|||2-Sided|95.0|-7.49|5.19|||||||
1734075|NCT00515502|3192721|Superiority or Other||Mean Difference (Final Values)|1.34|Standard Error of the Mean|2.507|||2-Sided|95.0|-3.65|6.34|||||||
1734076|NCT00515502|3192721|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|2.542|||2-Sided|95.0|-4.98|5.15|||||||
1734077|NCT00515502|3192722|Superiority or Other||Mean Difference (Final Values)|-2.424|Standard Error of the Mean|4.2233|||2-Sided|95.0|-10.84|5.993|||||||
1734078|NCT00515502|3192722|Superiority or Other||Mean Difference (Final Values)|0.704|Standard Error of the Mean|3.3916|||2-Sided|95.0|-6.064|7.473|||||||
1734079|NCT00515502|3192722|Superiority or Other||Mean Difference (Final Values)|-0.66|Standard Error of the Mean|3.1121|||2-Sided|95.0|-6.873|5.554|||||||
1734080|NCT00515502|3192722|Superiority or Other||Mean Difference (Final Values)|0.362|Standard Error of the Mean|3.1891|||2-Sided|95.0|-6.003|6.726|||||||
1734081|NCT00515502|3192722|Superiority or Other||Mean Difference (Final Values)|-2.062|Standard Error of the Mean|3.0952|||2-Sided|95.0|-8.247|4.122|||||||
1734082|NCT00515502|3192722|Superiority or Other||Mean Difference (Final Values)|1.066|Standard Error of the Mean|2.2776|||2-Sided|95.0|-3.495|5.627|||||||
1734083|NCT00515502|3192722|Superiority or Other||Mean Difference (Final Values)|-0.298|Standard Error of the Mean|2.3297|||2-Sided|95.0|-4.961|4.365|||||||
1734084|NCT00515502|3192723|Superiority or Other||Mean Difference (Final Values)|3.63|Standard Error of the Mean|5.634|||2-Sided|95.0|-7.59|14.85|||||||
1734085|NCT00515502|3192723|Superiority or Other||Mean Difference (Final Values)|6.86|Standard Error of the Mean|4.622|||2-Sided|95.0|-2.35|16.08|||||||
1734086|NCT00515502|3192723|Superiority or Other||Mean Difference (Final Values)|1.86|Standard Error of the Mean|4.264|||2-Sided|95.0|-6.65|10.37|||||||
1734087|NCT00515502|3192723|Superiority or Other||Mean Difference (Final Values)|-5.17|Standard Error of the Mean|4.347|||2-Sided|95.0|-13.84|3.5|||||||
1734088|NCT00515502|3192723|Superiority or Other||Mean Difference (Final Values)|-1.54|Standard Error of the Mean|4.268|||2-Sided|95.0|-10.06|6.98|||||||
1734089|NCT00515502|3192723|Superiority or Other||Mean Difference (Final Values)|1.69|Standard Error of the Mean|3.193|||2-Sided|95.0|-4.7|8.09|||||||
1734090|NCT00515502|3192723|Superiority or Other||Mean Difference (Final Values)|-3.31|Standard Error of the Mean|3.256|||2-Sided|95.0|-9.82|3.21|||||||
1734091|NCT00515502|3192724|Superiority or Other||Mean Difference (Final Values)|5.53|Standard Error of the Mean|1.867|||2-Sided|95.0|1.81|9.25|||||||
1734092|NCT00515502|3192724|Superiority or Other||Mean Difference (Final Values)|1.8|Standard Error of the Mean|1.514|||2-Sided|95.0|-1.22|4.82|||||||
1734093|NCT00515502|3192724|Superiority or Other||Mean Difference (Final Values)|0.35|Standard Error of the Mean|1.366|||2-Sided|95.0|-2.38|3.07|||||||
1734094|NCT00515502|3192724|Superiority or Other||Mean Difference (Final Values)|-3.32|Standard Error of the Mean|1.409|||2-Sided|95.0|-6.13|-0.5|||||||
1734095|NCT00515502|3192724|Superiority or Other||Mean Difference (Final Values)|2.21|Standard Error of the Mean|1.335|||2-Sided|95.0|-0.46|4.88|||||||
1734096|NCT00515502|3192724|Superiority or Other||Mean Difference (Final Values)|-1.51|Standard Error of the Mean|1.006|||2-Sided|95.0|-3.53|0.5|||||||
1734097|NCT00515502|3192724|Superiority or Other||Mean Difference (Final Values)|-2.97|Standard Error of the Mean|1.051|||2-Sided|95.0|-5.08|-0.87|||||||
1734098|NCT00515502|3192725|Superiority or Other||Mean Difference (Final Values)|5.7|Standard Error of the Mean|2.35|||2-Sided|95.0|1.0|10.4|||||||
1734099|NCT00515502|3192725|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|1.9|||2-Sided|95.0|-3.5|4.1|||||||
1734100|NCT00515502|3192725|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|1.71|||2-Sided|95.0|-3.5|3.3|||||||
1734101|NCT00515502|3192725|Superiority or Other||Mean Difference (Final Values)|-2.4|Standard Error of the Mean|1.77|||2-Sided|95.0|-5.9|1.2|||||||
1734102|NCT00515502|3192725|Superiority or Other||Mean Difference (Final Values)|3.3|Standard Error of the Mean|1.67|||2-Sided|95.0|0.0|6.6|||||||
1734103|NCT00515502|3192725|Superiority or Other||Mean Difference (Final Values)|-2.1|Standard Error of the Mean|1.25|||2-Sided|95.0|-4.6|0.4|||||||
1734104|NCT00515502|3192725|Superiority or Other||Mean Difference (Final Values)|-2.5|Standard Error of the Mean|1.31|||2-Sided|95.0|-5.1|0.2|||||||
1734105|NCT00515502|3192726|Superiority or Other||Mean Difference (Final Values)|0.82|Standard Error of the Mean|3.618|||2-Sided|95.0|-6.39|8.02|||||||
1734106|NCT00515502|3192726|Superiority or Other||Mean Difference (Final Values)|-2.19|Standard Error of the Mean|2.898|||2-Sided|95.0|-7.97|3.59|||||||
1734107|NCT00515502|3192726|Superiority or Other||Mean Difference (Final Values)|-2.73|Standard Error of the Mean|2.562|||2-Sided|95.0|-7.84|2.38|||||||
1734108|NCT00515502|3192726|Superiority or Other||Mean Difference (Final Values)|0.31|Standard Error of the Mean|2.697|||2-Sided|95.0|-5.07|5.69|||||||
1734109|NCT00515502|3192726|Superiority or Other||Mean Difference (Final Values)|1.12|Standard Error of the Mean|2.474|||2-Sided|95.0|-3.82|6.07|||||||
1734110|NCT00515502|3192726|Superiority or Other||Mean Difference (Final Values)|-1.88|Standard Error of the Mean|1.834|||2-Sided|95.0|-5.56|1.79|||||||
1734111|NCT00515502|3192726|Superiority or Other||Mean Difference (Final Values)|-2.42|Standard Error of the Mean|1.902|||2-Sided|95.0|-6.23|1.39|||||||
1734112|NCT00515502|3192727|Superiority or Other||Mean Difference (Final Values)|2.0|Standard Error of the Mean|4.0|||2-Sided|95.0|-5.9|10.0|||||||
1734113|NCT00515502|3192727|Superiority or Other||Mean Difference (Final Values)|-4.8|Standard Error of the Mean|3.2|||2-Sided|95.0|-11.2|1.6|||||||
1734114|NCT00515502|3192727|Superiority or Other||Mean Difference (Final Values)|-2.0|Standard Error of the Mean|2.83|||2-Sided|95.0|-7.7|3.6|||||||
1734115|NCT00515502|3192727|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Error of the Mean|2.98|||2-Sided|95.0|-4.7|7.2|||||||
1734116|NCT00515502|3192727|Superiority or Other||Mean Difference (Final Values)|3.3|Standard Error of the Mean|2.74|||2-Sided|95.0|-2.2|8.7|||||||
1734117|NCT00515502|3192727|Superiority or Other||Mean Difference (Final Values)|-3.5|Standard Error of the Mean|2.03|||2-Sided|95.0|-7.6|0.6|||||||
1734118|NCT00515502|3192727|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|2.11|||2-Sided|95.0|-5.0|3.4|||||||
1734119|NCT00515502|3192728|Superiority or Other||Mean Difference (Final Values)|3.68|Standard Error of the Mean|1.67|||2-Sided|95.0|0.34|7.02|||||||
1734120|NCT00515502|3192728|Superiority or Other||Mean Difference (Final Values)|2.76|Standard Error of the Mean|1.257|||2-Sided|95.0|0.24|5.28|||||||
1734121|NCT00515502|3192728|Superiority or Other||Mean Difference (Final Values)|0.95|Standard Error of the Mean|1.19|||2-Sided|95.0|-1.44|3.33|||||||
1734122|NCT00515502|3192728|Superiority or Other||Mean Difference (Final Values)|-1.72|Standard Error of the Mean|1.193|||2-Sided|95.0|-4.11|0.67|||||||
1734123|NCT00515502|3192728|Superiority or Other||Mean Difference (Final Values)|1.95|Standard Error of the Mean|1.151|||2-Sided|95.0|-0.35|4.26|||||||
1734124|NCT00515502|3192728|Superiority or Other||Mean Difference (Final Values)|1.04|Standard Error of the Mean|0.798|||2-Sided|95.0|-0.57|2.64|||||||
1734125|NCT00515502|3192728|Superiority or Other||Mean Difference (Final Values)|-0.78|Standard Error of the Mean|0.844|||2-Sided|95.0|-2.47|0.92|||||||
1734126|NCT00515502|3192729|Superiority or Other||Mean Difference (Final Values)|4.8|Standard Error of the Mean|2.46|||2-Sided|95.0|-0.1|9.7|||||||
1734127|NCT00515502|3192729|Superiority or Other||Mean Difference (Final Values)|3.1|Standard Error of the Mean|1.89|||2-Sided|95.0|-0.7|6.9|||||||
1734128|NCT00515502|3192729|Superiority or Other||Mean Difference (Final Values)|2.3|Standard Error of the Mean|1.78|||2-Sided|95.0|-1.3|5.8|||||||
1734129|NCT00515502|3192729|Superiority or Other||Mean Difference (Final Values)|-2.7|Standard Error of the Mean|1.79|||2-Sided|95.0|-6.2|0.9|||||||
1734130|NCT00515502|3192729|Superiority or Other||Mean Difference (Final Values)|2.1|Standard Error of the Mean|1.77|||2-Sided|95.0|-1.4|5.7|||||||
1734131|NCT00515502|3192729|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|1.25|||2-Sided|95.0|-2.1|2.9|||||||
1734132|NCT00515502|3192729|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|1.31|||2-Sided|95.0|-3.0|2.2|||||||
1734133|NCT00515463|3192802|Superiority or Other||Risk Difference (RD)|0.0||||||95.0|-0.7|0.7|||||||
1734134|NCT00515463|3192803|Superiority or Other||Risk Difference (RD)|0.0||||||95.0|-0.7|0.7|||||Risk difference > 0 indicates that incidence of binding anti-denosumab antibodies in denosumab PFS is greater than denosumab vial. 95% CI based on a normal approximation with continuity correction.||
1734135|NCT00515203|3192832|Superiority or Other|||||||0.2098|||||||Fisher Exact||||
1734136|NCT00515203|3192833|Superiority or Other|||||||0.0008|||||||Fisher Exact||||
1734137|NCT00515203|3192834|Superiority or Other|||||||0.0008|||||||Fisher Exact||||
1734138|NCT00515203|3192835|Superiority or Other|||||||0.3651|||||||Cochran-Mantel-Haenszel||||
1734139|NCT00515203|3192836|Superiority or Other|||||||0.0019|||||||Cochran-Mantel-Haenszel||||
1734140|NCT00515099|3192845|Superiority or Other|||||||0.16||||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from Baseline to Month 24|
1734141|NCT00515099|3192845|Superiority or Other|||||||0.07||||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in HbA1c from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from Baseline to Month 12|
1734142|NCT00515099|3192846|Superiority or Other|||||||0.33||||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||4-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Missing Month 24 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL.|
1734143|NCT00515099|3192846|Superiority or Other|||||||0.38||||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||2-Hour AUC change from baseline (pre-initiation treatment) to Month 24. Primary imputation method used for missing Month 24 AUC. Measuring range for C-peptide is 0.05-30 ng/mL.|
1734144|NCT00515099|3192847|Superiority or Other|||||||0.75||||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|Fisher Exact|||Comparison of groups up to Month 24|
1734145|NCT00515099|3192847|Superiority or Other||||||>|0.099||||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|Fisher Exact|||Comparison of groups up to Month 12|
1734146|NCT00515099|3192849|Superiority or Other|||||||0.14||||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from baseline (pre-treatment initiation) to Month 24|
1734147|NCT00515099|3192849|Superiority or Other|||||||0.59||||||P-value is for testing treatment effect using an analysis of covariance with baseline level as a covariate and change in insulin use from baseline as the outcome variable|ANCOVA|||Comparison of groups for change from baseline (pre-treatment initiation) to Month 12|
1734148|NCT00515099|3192850|Superiority or Other|||||||0.4||||||P-value is for testing treatment effect using an analysis of covariance with baseline In(AUC+1) as a covariate and change in In(AUC+1) from baseline as the outcome variable|ANCOVA|||Missing Month 12 AUC values were not imputed. Measuring range for C-peptide is 0.05-30 ng/mL|
1734149|NCT00515099|3192851|Superiority or Other|||||||0.6||||||P-value is for testing treatment effect using an analysis of covariance with baseline ln(AUC+1) as a covariate and change in ln(AUC+1) from baseline as the outcome variable.|ANCOVA|||Primary imputation method used for missing Month 12 AUC. Measuring range for C-peptide is 0.05-30 ng/mL|
1734150|NCT00515034|3192860|Non-Inferiority or Equivalence|Percent of participants who are clinically cured including 95% confidence intervals are provided.|Risk Difference (RD)|18.7|||||2-Sided|95.0|-13.2|50.6|||||Treatment difference (doripenem minus imipenem) in percent of participants who are clinically cured.|There is no formal hypothesis test for this outcome. Only summary data are presented.|
1734151|NCT00515034|3192861|Non-Inferiority or Equivalence|Percent of participants who are clinically cured including 95% confidence intervals are provided.|Risk Difference (RD)|-13.8|||||2-Sided|95.0|-54.4|26.8|||||Treatment difference (doripenem minus imipenem/cilastatin) in percent of participants who are clinically cured.|There is no formal hypothesis test for this outcome. Only summary data are provided.|
1734152|NCT00514943|3192880|Superiority or Other||Hazard Ratio (HR)|1.067||||0.758|2-Sided|95.0|0.708|1.608|||Regression, Cox||Hazard ratio, 95% CI and p−value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or >=1)||
1734153|NCT00514943|3192881|Superiority or Other||Hazard Ratio (HR)|0.725||||0.219|2-Sided|95.0|0.434|1.212|||Regression, Cox||Hazard ratio, 95% CI and p−value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or >=1)||
1734154|NCT00514943|3192882|Superiority or Other||Hazard Ratio (HR)|0.942||||0.764|2-Sided|95.0|0.64|1.387|||Regression, Cox||Hazard ratio, 95% CI and p−value are calculated from the Cox proportional hazards model stratified by the number of prior chemotherapies for R/M setting (0 or >=1)||
1734155|NCT00514943|3192895|Superiority or Other||Mean Difference (Final Values)|-1.49||||0.7606|2-Sided|95.0|-11.188|8.202||P-value obtained from fitting an ANCOVA model including treatment, stratification factor prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance of target lesions.|ANCOVA|Receipt of prior chemotherapy for recurrent/metastatic disease and the baseline sum of longest distance for target lesions are covariates|Mean difference calculated is actually the adjusted mean difference.||
1734156|NCT00514917|3192906|Superiority or Other||Hazard Ratio (HR)|1.29||||0.0501|2-Sided|95.0|1.0|1.65||A priori threshold for statistical significance = 0.05|Log Rank|P-value was not adjusted for multiplicity of tests.|The hazard ratio Leuprolide+Bicalutamide vs. Docetaxel+Leuprolide+Bicalutamide was estimated using an un-stratified Cox proportional hazards model. A hazard ratio >1 indicates a lower risk of Docetaxel+Leuprolide, compared to Leuprolide.|"Null hypothesis: No difference between new treatment combination (Docetaxel+Leuprolide+Bicalutamide) and conventional treatment (Leuprolide+Bicalutamide).~The study was sized to have 90% power to detect a difference between treatment arms at a 2-sided 0.05 significance level with 186 events and anticipating 10% non-evaluable participants."|
1734157|NCT00514904|3192920|Non-Inferiority|Criterion for assessment: upper limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the ratio between Nimenrix Group and Mencevax ACWY Group being lower than or equal to the pre-defined clinical limit ratio of 3.0 in the percentage of subjects with any grade 3 general symptoms.|Risk Ratio (RR)|3.34||||0.2202|2-Sided|95.0|0.56|20.25|||Chi-squared||||
1734158|NCT00514904|3192921|Non-Inferiority|Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%.|Difference in percentage|23.92|||||2-Sided|95.0|18.02|30.3|||||||
1734159|NCT00514904|3192921|Non-Inferiority|Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%.|Difference in percentage|6.35|||||2-Sided|95.0|2.68|11.08|||||||
1734160|NCT00514904|3192921|Non-Inferiority|Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%.|Difference in percentage|24.47|||||2-Sided|95.0|17.52|31.87|||||||
1734161|NCT00514904|3192921|Non-Inferiority|Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] greater than or equal to (≥) -10%.|Difference in percentage|14.77|||||2-Sided|95.0|10.26|20.23|||||||
1734162|NCT00514735|3192935|Superiority or Other||||||<|0.025|||||||Mixed Models Analysis||||
1734163|NCT00514735|3192936|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1734164|NCT00514735|3192937|Superiority or Other|||||||0.06|||||||ANOVA|||"H0: μa = μm Ha: μa ≠ μm~where μa is the change of LVEF from baseline to 6 month in Ablation Management arm, and μm is the change of LVEF from baseline to 6 month in Medical Management arm."|
1734165|NCT00514735|3192938|Superiority or Other|||||||0.35|||||||ANOVA|||"H0: μa = μm Ha: μa ≠ μm~where μa is the change of LAD from baseline to 6 month in Ablation Management arm, and μm is the change of LAD from baseline to 6 month in Medical Management arm."|
1734166|NCT00514735|3192940|Non-Inferiority or Equivalence|This objective was not statistically powered. The non-inferiority chronic safety margin was 0.06.||||||0.0033|||||||t-test, 1 sided|||"H0: Pa ≥ Pm + 0.06 Ha: Pa < Pm + 0.06~where Pa is the proportion of failed subjects in the ablation management arm and Pm is the proportion of failed subjects in the optimal medical management/drug therapy arm."|
1734167|NCT00514735|3192941|Superiority or Other|||||||0.1427||||||An exact, one-sample binomial test was conducted at a one-sided α=0.025 level of significance.|Fisher Exact|||"H0: Pa ≥ 0.16 Ha: Pa < 0.16~where Pa is the proportion of acute safety failures in the ablation management arm."|
1734168|NCT00514735|3192942|Superiority or Other||||||<|0.0001||||||In order to maintain the overall level of significance at the α=0.025 level after a planned interim analysis using α=0.003, this test will actually be performed using an adjusted α=0.0245 at the completion of the study.|Chi-squared|||"H0: Pa ≤ Pm Ha: Pa > Pm~where Pa is the proportion of successfully treated subjects in the ablation management arm and Pm is the proportion of successfully treated subjects in the optimal medical management/drug therapy arm."|
1734169|NCT00514683|3192947|Superiority or Other||Hazard Ratio (HR)|0.91||||0.6505|2-Sided|95.0|0.605|1.369|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734170|NCT00514683|3192947|Superiority or Other||Hazard Ratio (HR)|0.805||||0.303|2-Sided|95.0|0.534|1.216|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734171|NCT00514683|3192947|Superiority or Other||Hazard Ratio (HR)|0.958||||0.8293|2-Sided|95.0|0.646|1.419|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734172|NCT00514683|3192947|Superiority or Other||Hazard Ratio (HR)|1.055||||0.7883|2-Sided|95.0|0.713|1.563|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734173|NCT00514683|3192948|Superiority or Other||Hazard Ratio (HR)|0.225||||0.06|2-Sided|95.0|0.048|1.065|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734174|NCT00514683|3192948|Superiority or Other||Hazard Ratio (HR)|0.19||||0.0379|2-Sided|95.0|0.04|0.911|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734175|NCT00514683|3192948|Superiority or Other||Hazard Ratio (HR)|0.316||||0.0925|2-Sided|95.0|0.083|1.209|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734176|NCT00514683|3192948|Superiority or Other||Hazard Ratio (HR)|1.173||||0.7449|2-Sided|95.0|0.448|3.072|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734177|NCT00514683|3192949|Superiority or Other||Hazard Ratio (HR)|0.158||||0.0161|2-Sided|95.0|0.035|0.711|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734178|NCT00514683|3192949|Superiority or Other||Hazard Ratio (HR)|0.517||||0.1891|2-Sided|95.0|0.193|1.384|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734179|NCT00514683|3192949|Superiority or Other||Hazard Ratio (HR)|0.841||||0.6862|2-Sided|95.0|0.362|1.952|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734180|NCT00514683|3192949|Superiority or Other||Hazard Ratio (HR)|0.758||||0.5206|2-Sided|95.0|0.326|1.765|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734181|NCT00514683|3192950|Superiority or Other||Risk Ratio (RR)|0.22||||0.0324|2-Sided|95.0|0.056|0.882|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off−set variable and age, height, gender, region (all effects fixed).||
1734182|NCT00514683|3192950|Superiority or Other||Risk Ratio (RR)|0.49||||0.1944|2-Sided|95.0|0.167|1.438|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off−set variable and age, height, gender, region (all effects fixed).||
1734183|NCT00514683|3192950|Superiority or Other||Risk Ratio (RR)|0.73||||0.5326|2-Sided|95.0|0.278|1.938|||Negative Binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off−set variable and age, height, gender, region (all effects fixed).||
1734184|NCT00514683|3192950|Superiority or Other||Risk Ratio (RR)|0.9||||0.8282|2-Sided|95.0|0.347|2.336|||Negative binomial model||Risk ratio is actually Rate Ratio. Rate ratio is calculated based on Negative binomial model with default log link function and adjusted for an off−set variable and age, height, gender, region (all effects fixed).||
1734185|NCT00514683|3192951|Superiority or Other||Risk Ratio (RR)|0.16||||0.015|2-Sided|95.0|0.03|0.7||Based on the statistic of ln(risk ratio) having a normal distribution N[0,[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) ] ]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.||
1734186|NCT00514683|3192951|Superiority or Other||Risk Ratio (RR)|0.48||||0.1381|2-Sided|95.0|0.18|1.27||Based on the statistic of ln(risk ratio) having a normal distribution N[0,[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) ] ]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.||
1734187|NCT00514683|3192951|Superiority or Other||Risk Ratio (RR)|0.8||||0.5926|2-Sided|95.0|0.34|1.84||Based on the statistic of ln(risk ratio) having a normal distribution N[0,[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) ] ]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.||
1734188|NCT00514683|3192951|Superiority or Other||Risk Ratio (RR)|0.83||||0.6671|2-Sided|95.0|0.36|1.93||Based on the statistic of ln(risk ratio) having a normal distribution N[0,[ (1/number with at least one exacerbation in Nintedanib group) + (1//number with at least one exacerbation in placebo) ] ]|Negative binomial model|Default log link function and adjusted for an off-set variable (logarithm of the follow-up time), for gender, height, age and region as fixed effects.|Risk ratio lower than 1 favours the treatment group over placebo.||
1734189|NCT00514683|3192952|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.0671||0.7701|2-Sided|95.0|-0.112|0.152|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734190|NCT00514683|3192952|Superiority or Other||Mean Difference (Final Values)|-0.006|Standard Error of the Mean|0.0651||0.9209|2-Sided|95.0|-0.134|0.121|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734191|NCT00514683|3192952|Superiority or Other||Mean Difference (Final Values)|-0.021|Standard Error of the Mean|0.065||0.7426|2-Sided|95.0|-0.149|0.106|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734192|NCT00514683|3192952|Superiority or Other||Mean Difference (Final Values)|-0.033|Standard Error of the Mean|0.0676||0.6306|2-Sided|95.0|-0.165|0.1|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734193|NCT00514683|3192953|Superiority or Other||Mean Difference (Final Values)|0.201|Standard Error of the Mean|0.0604||0.0009|2-Sided|95.0|0.083|0.32|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734194|NCT00514683|3192953|Superiority or Other||Mean Difference (Final Values)|0.109|Standard Error of the Mean|0.0585||0.0632|2-Sided|95.0|-0.006|0.224|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734195|NCT00514683|3192953|Superiority or Other||Mean Difference (Final Values)|0.084|Standard Error of the Mean|0.0584||0.1498|2-Sided|95.0|-0.031|0.199|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734196|NCT00514683|3192953|Superiority or Other||Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.0609||0.1129|2-Sided|95.0|-0.023|0.217|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734197|NCT00514683|3192954|Superiority or Other||Mean Difference (Final Values)|0.337|Standard Error of the Mean|0.0874||0.0001|2-Sided|95.0|0.165|0.509|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734198|NCT00514683|3192954|Superiority or Other||Mean Difference (Final Values)|0.121|Standard Error of the Mean|0.0843||0.151|2-Sided|95.0|-0.044|0.287|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734199|NCT00514683|3192954|Superiority or Other||Mean Difference (Final Values)|0.103|Standard Error of the Mean|0.0839||0.2221|2-Sided|95.0|-0.062|0.268|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734200|NCT00514683|3192954|Superiority or Other||Mean Difference (Final Values)|0.063|Standard Error of the Mean|0.0884||0.4792|2-Sided|95.0|-0.111|0.236|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734201|NCT00514683|3192955|Superiority or Other||Mean Difference (Final Values)|0.123|Standard Error of the Mean|0.0675||0.0703|2-Sided|95.0|-0.01|0.255|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734202|NCT00514683|3192955|Superiority or Other||Mean Difference (Final Values)|0.025|Standard Error of the Mean|0.0654||0.7062|2-Sided|95.0|-0.104|0.153|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734203|NCT00514683|3192955|Superiority or Other||Mean Difference (Final Values)|0.066|Standard Error of the Mean|0.0652||0.3149|2-Sided|95.0|-0.063|0.194|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734204|NCT00514683|3192955|Superiority or Other||Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.068||0.7789|2-Sided|95.0|-0.153|0.115|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734205|NCT00514683|3192956|Superiority or Other||Mean Difference (Final Values)|0.358|Standard Error of the Mean|0.1008||0.0004|2-Sided|95.0|0.16|0.556|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734206|NCT00514683|3192956|Superiority or Other||Mean Difference (Final Values)|0.158|Standard Error of the Mean|0.0977||0.1059|2-Sided|95.0|-0.034|0.351|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734207|NCT00514683|3192956|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.0974||0.1506|2-Sided|95.0|-0.051|0.332|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734208|NCT00514683|3192956|Superiority or Other||Mean Difference (Final Values)|0.022|Standard Error of the Mean|0.1015||0.8288|2-Sided|95.0|-0.178|0.222|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734209|NCT00514683|3192957|Superiority or Other||Odds Ratio (OR)|2.2||||0.0341|2-Sided|95.0|1.05|4.61|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.||
1734210|NCT00514683|3192957|Superiority or Other||Odds Ratio (OR)|2.7||||0.0069|2-Sided|95.0|1.29|5.66|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.||
1734211|NCT00514683|3192957|Superiority or Other||Odds Ratio (OR)|1.9||||0.0891|2-Sided|95.0|0.9|4.01|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.||
1734212|NCT00514683|3192957|Superiority or Other||Odds Ratio (OR)|1.54||||0.2698|2-Sided|95.0|0.72|3.31|||Cochran-Mantel-Haenszel|Based on an Cochran-Mantel-Haenszel test to adjust for region effect.|In case of missing data, patient has been set to non-responder. Odds ratio lower than 1 favours the treatment group over placebo.||
1734213|NCT00514683|3192958|Superiority or Other||Mean Difference (Final Values)|-7.16|Standard Error of the Mean|2.494||0.0043|2-Sided|95.0|-12.06|-2.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734214|NCT00514683|3192958|Superiority or Other||Mean Difference (Final Values)|-4.49|Standard Error of the Mean|2.453||0.0682|2-Sided|95.0|-9.31|0.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734287|NCT00514683|3192976|Superiority or Other||Hazard Ratio (HR)|0.29||||0.0653|2-Sided|95.0|0.078|1.081|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734215|NCT00514683|3192958|Superiority or Other||Mean Difference (Final Values)|-3.94|Standard Error of the Mean|2.44||0.1069|2-Sided|95.0|-8.74|0.85|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734216|NCT00514683|3192958|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|2.484||0.9708|2-Sided|95.0|-4.98|4.79|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734217|NCT00514683|3192959|Superiority or Other||Mean Difference (Final Values)|-4.35|Standard Error of the Mean|2.597||0.0948|2-Sided|95.0|-9.46|0.76|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734218|NCT00514683|3192959|Superiority or Other||Mean Difference (Final Values)|-3.42|Standard Error of the Mean|2.548||0.1799|2-Sided|95.0|-8.43|1.59|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734219|NCT00514683|3192959|Superiority or Other||Mean Difference (Final Values)|-2.48|Standard Error of the Mean|2.54||0.3286|2-Sided|95.0|-7.48|2.51|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734220|NCT00514683|3192959|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|2.586||0.8458|2-Sided|95.0|-5.59|4.58|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734221|NCT00514683|3192960|Superiority or Other||Mean Difference (Final Values)|-9.6|Standard Error of the Mean|3.184||0.0028|2-Sided|95.0|-15.86|-3.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734222|NCT00514683|3192960|Superiority or Other||Mean Difference (Final Values)|-4.12|Standard Error of the Mean|3.138||0.1897|2-Sided|95.0|-10.29|2.05|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734223|NCT00514683|3192960|Superiority or Other||Mean Difference (Final Values)|-4.34|Standard Error of the Mean|3.126||0.1659|2-Sided|95.0|-10.49|1.81|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734224|NCT00514683|3192960|Superiority or Other||Mean Difference (Final Values)|-3.06|Standard Error of the Mean|3.183||0.337|2-Sided|95.0|-9.32|3.2|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734225|NCT00514683|3192961|Superiority or Other||Mean Difference (Final Values)|-6.12|Standard Error of the Mean|2.262||0.0071|2-Sided|95.0|-10.57|-1.67|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734226|NCT00514683|3192961|Superiority or Other||Mean Difference (Final Values)|-3.98|Standard Error of the Mean|2.221||0.0741|2-Sided|95.0|-8.35|0.39|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734227|NCT00514683|3192961|Superiority or Other||Mean Difference (Final Values)|-3.28|Standard Error of the Mean|2.213||0.1389|2-Sided|95.0|-7.63|1.07|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734228|NCT00514683|3192961|Superiority or Other||Mean Difference (Final Values)|-0.79|Standard Error of the Mean|2.253||0.725|2-Sided|95.0|-5.22|3.64|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734229|NCT00514683|3192962|Superiority or Other||Mean Difference (Final Values)|-1.67|Standard Error of the Mean|0.683||0.0152|2-Sided|95.0|-3.01|-0.32|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.||
1734230|NCT00514683|3192962|Superiority or Other||Mean Difference (Final Values)|-1.77|Standard Error of the Mean|0.684||0.0099|2-Sided|95.0|-3.12|-0.43|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.||
1734231|NCT00514683|3192962|Superiority or Other||Mean Difference (Final Values)|-1.24|Standard Error of the Mean|0.68||0.0685|2-Sided|95.0|-2.58|0.09|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.||
1734232|NCT00514683|3192962|Superiority or Other||Mean Difference (Final Values)|-1.35|Standard Error of the Mean|0.68||0.0479|2-Sided|95.0|-2.69|-0.01|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated.||
1734233|NCT00514683|3192963|Superiority or Other||Odds Ratio (OR)|1.551||||0.1705|2-Sided|95.0|0.828|2.906|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.||
1734234|NCT00514683|3192963|Superiority or Other||Odds Ratio (OR)|1.123||||0.7136|2-Sided|95.0|0.604|2.089|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.||
1734235|NCT00514683|3192963|Superiority or Other||Odds Ratio (OR)|0.994||||0.985|2-Sided|95.0|0.536|1.844|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.||
1734236|NCT00514683|3192963|Superiority or Other||Odds Ratio (OR)|1.014||||0.9646|2-Sided|95.0|0.54|1.906|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo. Negative change indicates worsening.||
1734237|NCT00514683|3192964|Superiority or Other||Mean Difference (Final Values)|-0.333|Standard Error of the Mean|0.3252||0.3064|2-Sided|95.0|-0.973|0.307|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734238|NCT00514683|3192964|Superiority or Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.3159||0.6358|2-Sided|95.0|-0.771|0.472|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734239|NCT00514683|3192964|Superiority or Other||Mean Difference (Final Values)|-0.078|Standard Error of the Mean|0.3109||0.8009|2-Sided|95.0|-0.69|0.533|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734240|NCT00514683|3192964|Superiority or Other||Mean Difference (Final Values)|0.112|Standard Error of the Mean|0.3272||0.7329|2-Sided|95.0|-0.532|0.755|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734241|NCT00514683|3192965|Superiority or Other||Mean Difference (Final Values)|-0.141|Standard Error of the Mean|0.2257||0.5338|2-Sided|95.0|-0.584|0.303|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734242|NCT00514683|3192965|Superiority or Other||Mean Difference (Final Values)|0.033|Standard Error of the Mean|0.2193||0.8822|2-Sided|95.0|-0.399|0.464|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734243|NCT00514683|3192965|Superiority or Other||Mean Difference (Final Values)|-0.182|Standard Error of the Mean|0.2158||0.3995|2-Sided|95.0|-0.606|0.242|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734244|NCT00514683|3192965|Superiority or Other||Mean Difference (Final Values)|0.055|Standard Error of the Mean|0.2271||0.809|2-Sided|95.0|-0.392|0.502|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Positive change indicates worsening.||
1734245|NCT00514683|3192966|Superiority or Other||Mean Difference (Final Values)|6.32|Standard Error of the Mean|16.98||0.7101|2-Sided|95.0|-27.08|39.72|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734246|NCT00514683|3192966|Superiority or Other||Mean Difference (Final Values)|-1.13|Standard Error of the Mean|16.506||0.9454|2-Sided|95.0|-33.6|31.34|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734247|NCT00514683|3192966|Superiority or Other||Mean Difference (Final Values)|-13.17|Standard Error of the Mean|16.234||0.4176|2-Sided|95.0|-45.11|18.76|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734248|NCT00514683|3192966|Superiority or Other||Median Difference (Final Values)|-11.24|Standard Error of the Mean|17.089||0.5111|2-Sided|95.0|-44.86|22.37|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734249|NCT00514683|3192967|Superiority or Other||Odds Ratio (OR)|1.676||||0.1177|2-Sided|95.0|0.878|3.202|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734250|NCT00514683|3192967|Superiority or Other||Odds Ratio (OR)|0.931||||0.8237|2-Sided|95.0|0.498|1.741|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734251|NCT00514683|3192967|Superiority or Other||Odds Ratio (OR)|1.317||||0.3869|2-Sided|95.0|0.706|2.458|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734252|NCT00514683|3192967|Superiority or Other||Odds Ratio (OR)|0.892||||0.7307|2-Sided|95.0|0.465|1.71|||Regression, Logistic|An ordinal logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734253|NCT00514683|3192968|Superiority or Other||Mean Difference (Final Values)|-0.121|Standard Error of the Mean|0.1448||0.4053|2-Sided|95.0|-0.406|0.164|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734254|NCT00514683|3192968|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.14||0.5678|2-Sided|95.0|-0.355|0.195|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734255|NCT00514683|3192968|Superiority or Other||Mean Difference (Final Values)|-0.155|Standard Error of the Mean|0.1399||0.2679|2-Sided|95.0|-0.43|0.12|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734256|NCT00514683|3192968|Superiority or Other||Mean Difference (Final Values)|0.098|Standard Error of the Mean|0.1456||0.4998|2-Sided|95.0|-0.188|0.385|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734257|NCT00514683|3192969|Superiority or Other||Odds Ratio (OR)|0.972||||0.9375|2-Sided|95.0|0.476|1.985|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734258|NCT00514683|3192969|Superiority or Other||Odds Ratio (OR)|0.993||||0.9829|2-Sided|95.0|0.506|1.949|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734259|NCT00514683|3192969|Superiority or Other||Odds Ratio (OR)|1.216||||0.5758|2-Sided|95.0|0.613|2.41|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734260|NCT00514683|3192969|Superiority or Other||Odds Ratio (OR)|1.051||||0.8887|2-Sided|95.0|0.521|2.122|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734261|NCT00514683|3192970|Superiority or Other||Odds Ratio (OR)|0.665||||0.2548|2-Sided|95.0|0.33|1.341|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734262|NCT00514683|3192970|Superiority or Other||Odds Ratio (OR)|0.78||||0.4596|2-Sided|95.0|0.403|1.508|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734263|NCT00514683|3192970|Superiority or Other||Odds Ratio (OR)|0.916||||0.7989|2-Sided|95.0|0.467|1.797|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734264|NCT00514683|3192970|Superiority or Other||Odds Ratio (OR)|1.093||||0.7997|2-Sided|95.0|0.549|2.175|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734265|NCT00514683|3192971|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.734||0.8523|2-Sided|95.0|-1.58|1.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734266|NCT00514683|3192971|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.685||0.8721|2-Sided|95.0|-1.46|1.24|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734267|NCT00514683|3192971|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.696||0.7871|2-Sided|95.0|-1.18|1.56|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734268|NCT00514683|3192971|Superiority or Other||Mean Difference (Final Values)|0.79|Standard Error of the Mean|0.715||0.2716|2-Sided|95.0|-0.62|2.19|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734269|NCT00514683|3192972|Superiority or Other||Mean Difference (Final Values)|1.35|Standard Error of the Mean|2.523||0.5942|2-Sided|95.0|-3.62|6.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734270|NCT00514683|3192972|Superiority or Other||Mean Difference (Final Values)|0.41|Standard Error of the Mean|2.379||0.8631|2-Sided|95.0|-4.27|5.09|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734271|NCT00514683|3192972|Superiority or Other||Mean Difference (Final Values)|1.01|Standard Error of the Mean|2.412||0.6772|2-Sided|95.0|-3.74|5.75|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734272|NCT00514683|3192972|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|2.49||0.9811|2-Sided|95.0|-4.84|4.96|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734273|NCT00514683|3192973|Superiority or Other||Mean Difference (Final Values)|0.93|Standard Error of the Mean|2.387||0.697|2-Sided|95.0|-3.77|5.63|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734274|NCT00514683|3192973|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Error of the Mean|2.24||0.9181|2-Sided|95.0|-4.18|4.64|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734275|NCT00514683|3192973|Superiority or Other||Mean Difference (Final Values)|-1.31|Standard Error of the Mean|2.28||0.5656|2-Sided|95.0|-5.8|3.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734276|NCT00514683|3192973|Superiority or Other||Mean Difference (Final Values)|-1.08|Standard Error of the Mean|2.33||0.6443|2-Sided|95.0|-5.66|3.51|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734277|NCT00514683|3192974|Superiority or Other||Odds Ratio (OR)|0.313||||0.0317|2-Sided|95.0|0.108|0.903|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734278|NCT00514683|3192974|Superiority or Other||Odds Ratio (OR)|0.412||||0.0934|2-Sided|95.0|0.146|1.161|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734279|NCT00514683|3192974|Superiority or Other||Odds Ratio (OR)|0.682||||0.4318|2-Sided|95.0|0.262|1.773|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734280|NCT00514683|3192974|Superiority or Other||Odds Ratio (OR)|0.428||||0.1021|2-Sided|95.0|0.155|1.184|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734281|NCT00514683|3192975|Superiority or Other||Mean Difference (Final Values)|1.12|Standard Error of the Mean|0.483||0.0211|2-Sided|95.0|0.17|2.07|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734282|NCT00514683|3192975|Superiority or Other||Mean Difference (Final Values)|1.36|Standard Error of the Mean|0.482||0.0051|2-Sided|95.0|0.41|2.31|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734283|NCT00514683|3192975|Superiority or Other||Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.478||0.4956|2-Sided|95.0|-0.61|1.27|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734284|NCT00514683|3192975|Superiority or Other||Mean Difference (Final Values)|0.44|Standard Error of the Mean|0.483||0.3658|2-Sided|95.0|-0.51|1.39|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734285|NCT00514683|3192976|Superiority or Other||Hazard Ratio (HR)|0.732||||0.5383|2-Sided|95.0|0.271|1.977|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734286|NCT00514683|3192976|Superiority or Other||Hazard Ratio (HR)|0.35||||0.0847|2-Sided|95.0|0.106|1.154|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1741656|NCT00432809|3203959|Superiority or Other||||||<|0.001|||||||ANOVA||||
1734288|NCT00514683|3192976|Superiority or Other||Hazard Ratio (HR)|1.278||||0.5882|2-Sided|95.0|0.526|3.102|||Regression, Cox|Cox regression model with fixed terms for treatment, gender, age, height, region.|Hazard ratio lower than 1 favours the treatment group over placebo.||
1734289|NCT00514683|3192977|Superiority or Other||Odds Ratio (OR)|0.415||||0.0041|2-Sided|95.0|0.227|0.757|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734290|NCT00514683|3192977|Superiority or Other||Odds Ratio (OR)|0.657||||0.1649|2-Sided|95.0|0.363|1.189|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734291|NCT00514683|3192977|Superiority or Other||Odds Ratio (OR)|1.136||||0.6704|2-Sided|95.0|0.631|2.045|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734292|NCT00514683|3192977|Superiority or Other||Odds Ratio (OR)|0.911||||0.7543|2-Sided|95.0|0.506|1.637|||Regression, Logistic|Logistic regression model with fixed terms for treatment, baseline of corresponding continuous value, region.|Odds ratio lower than 1 favours the treatment group over placebo.||
1734293|NCT00514683|3192978|Superiority or Other||Mean Difference (Final Values)|5.44|Standard Error of the Mean|1.7||0.0015|2-Sided|95.0|2.1|8.78|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734294|NCT00514683|3192978|Superiority or Other||Mean Difference (Final Values)|3.84|Standard Error of the Mean|1.702||0.0246|2-Sided|95.0|0.49|7.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734295|NCT00514683|3192978|Superiority or Other||Mean Difference (Final Values)|0.8|Standard Error of the Mean|1.694||0.6366|2-Sided|95.0|-2.53|4.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734296|NCT00514683|3192978|Superiority or Other||Mean Difference (Final Values)|0.99|Standard Error of the Mean|1.692||0.5601|2-Sided|95.0|-2.34|4.31||ANCOVA with fixed terms for treatment, baseline, region.|ANCOVA||Mean difference to placebo is calculated. Negative change indicates worsening.||
1734297|NCT00514683|3192979|Superiority or Other||Mean Difference (Final Values)|5.47|Standard Error of the Mean|1.71||0.0015|2-Sided|95.0|2.11|8.83|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734298|NCT00514683|3192979|Superiority or Other||Mean Difference (Final Values)|3.81|Standard Error of the Mean|1.716||0.0271|2-Sided|95.0|0.43|7.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734299|NCT00514683|3192979|Superiority or Other||Mean Difference (Final Values)|0.86|Standard Error of the Mean|1.702||0.6155|2-Sided|95.0|-2.49|4.2|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734300|NCT00514683|3192979|Superiority or Other||Mean Difference (Final Values)|0.91|Standard Error of the Mean|1.702||0.592|2-Sided|95.0|-2.43|4.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734301|NCT00514683|3192980|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.046||0.0004|2-Sided|95.0|0.08|0.26|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734302|NCT00514683|3192980|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.046||0.0471|2-Sided|95.0|0.0|0.18|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734303|NCT00514683|3192980|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.046||0.4525|2-Sided|95.0|-0.06|0.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734304|NCT00514683|3192980|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.046||0.3644|2-Sided|95.0|-0.05|0.13|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734305|NCT00514683|3192981|Superiority or Other||Mean Difference (Final Values)|4.97|Standard Error of the Mean|1.319||0.0002|2-Sided|95.0|2.37|7.56|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734306|NCT00514683|3192981|Superiority or Other||Mean Difference (Final Values)|2.86|Standard Error of the Mean|1.324||0.0314|2-Sided|95.0|0.26|5.46|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734307|NCT00514683|3192981|Superiority or Other||Mean Difference (Final Values)|1.1|Standard Error of the Mean|1.312||0.4014|2-Sided|95.0|-1.48|3.68|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734308|NCT00514683|3192981|Superiority or Other||Mean Difference (Final Values)|1.43|Standard Error of the Mean|1.312||0.2774|2-Sided|95.0|-1.15|4.01|||ANCOVA|ANCOVA with fixed terms for treatment, baseline, region.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734309|NCT00514683|3192982|Superiority or Other|||||||0.0136||||||Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.|||
1734310|NCT00514683|3192982|Superiority or Other||Mean Difference (Final Values)|0.131|Standard Error of the Mean|0.053||0.0639|2-Sided|95.0|0.027|0.235||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734376|NCT00511836|3193210|Superiority or Other||||||<|0.013|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0|
1734311|NCT00514683|3192982|Superiority or Other|||||||0.5736||||||Additionally the p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.|||
1734312|NCT00514683|3192982|Superiority or Other||Mean Difference (Final Values)|0.028|Standard Error of the Mean|0.051||0.853|2-Sided|95.0|-0.071|0.128||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734313|NCT00514683|3192982|Superiority or Other|||||||0.6991||||||The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.|||
1734314|NCT00514683|3192982|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.051||0.792|2-Sided|95.0|-0.119|0.08||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734315|NCT00514683|3192982|Superiority or Other|||||||0.7558||||||The p-value from the hierarchical testing procedure was calculated as a sensitivity analysis|Mixed Models Analysis|MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.|||
1734316|NCT00514683|3192982|Superiority or Other||Mean Difference (Final Values)|0.016|Standard Error of the Mean|0.052||0.853|2-Sided|95.0|-0.086|0.118||The p-value presented is computed in the course of the closing testing procedure.|Mixed Models Analysis|MMRM with fixed terms for treatment*time, gender*height, gender*age and random terms for patient effect, patient*time.|Mean difference to placebo is calculated. Negative change indicates worsening.||
1734317|NCT00514514|3192997|Superiority or Other||Mean Difference (Net)|5.56|||<|0.0001|2-Sided|95.0|2.82|8.31|||ANCOVA||||
1734318|NCT00514449|3193001|Other||number of voxels in a cluster|2037.0||||0.004|2-Sided|||||p value is adjusted for multiple comparisons|ANCOVA||Time by treatment group interaction term||
1734319|NCT00513747|3193019|Superiority|||||||0.4645|||||||Log Rank||||
1734320|NCT00513747|3193020|Superiority|||||||0.0097|||||||Log Rank||||
1734321|NCT00513747|3193021|Superiority|||||||0.1521|||||||Log Rank||||
1734322|NCT00513682|3193031|Superiority or Other|||||||0.0009|||||||t-test, 1 sided||||
1734323|NCT00513682|3193032|Superiority or Other|||||||0.0013|||||||t-test, 1 sided||||
1734324|NCT00513617|3193036|Superiority or Other||Mean Difference (Final Values)|0.5213|Standard Error of the Mean|1.1553||0.557||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.|
1734325|NCT00513617|3193036|Superiority or Other||Mean Difference (Final Values)|-1.7867|Standard Error of the Mean|1.1101||0.015||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.|
1734326|NCT00513617|3193037|Superiority or Other||Mean Difference (Final Values)|2.3582|Standard Error of the Mean|4.1047||0.918||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.|
1734327|NCT00513617|3193037|Superiority or Other||Mean Difference (Final Values)|-0.1826|Standard Error of the Mean|0.0713||0.915||||||Alpha was set at 0.5|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo subtracted from Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.|
1734328|NCT00513617|3193039|Superiority or Other||Mean Difference (Final Values)|-0.098|Standard Error of the Mean|0.0713||0.133||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo was subtracted from High dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.|
1734329|NCT00513617|3193039|Superiority or Other||Mean Difference (Final Values)|-0.1254|Standard Error of the Mean|0.0705||0.08||||||Alpha was set at 0.05|Mixed Models Analysis|Null is tested using the F-test from a random effects longitudinal mixed model, with treatment and baseline measurement as fixed effects.|Placebo was subtracted from the Low dose|Null hypothesis is no difference between high vs. placebo and low vs. placebo in change from baseline at Week 12 post-randomization. Separate models were fit for pediatric and adult populations, however the combined population is entered here.|
1734330|NCT00513500|3193054|Superiority or Other||Risk Ratio (RR)|0.44||||||95.0|0.21|0.93|||||||
1734331|NCT00513500|3193055|Superiority or Other||Risk Ratio (RR)|0.23||||||95.0|0.14|0.38|||||||
1734332|NCT00513500|3193056|Superiority or Other||Risk Ratio (RR)|5.32||||||95.0|2.19|8.94|||||||
1734333|NCT00513474|3193060|Superiority|||||||0.036|||||||Gray's test for competing risks||||
1734334|NCT00513461|3193061|Superiority||Mean Difference (Net)|-3.66||||0.212|2-Sided||||||Two-Group t-test||||
1734335|NCT00513461|3193062|Superiority||Mean Difference (Net)|0.43||||0.878|2-Sided||||||Two-Group t-test||||
1734336|NCT00513461|3193075|Superiority||Mean Difference (Net)|7.78||||0.16|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1734337|NCT00513305|3193108|Superiority or Other||Cox Proportional Hazard|1.027||||0.8289|2-Sided|95.0|0.535|1.973|||Log Rank||Estimate based on Cox Proportional Hazards Model adjusting for age, Eastern Cooperative Oncology Group (ECOG) status, white blood count and presence of antecedent hematologic disorder.||
1734338|NCT00513305|3193111|Superiority or Other||Cox Proportional Hazard|2.31||||0.527|2-Sided|95.0|0.16|33.343|||Log Rank||Estimate based on Cox Proportional Hazards Model adjusting for age, Eastern Cooperative Oncology Group (ECOG) status, white blood count and presence of antecedent hematologic disorder.||
1734339|NCT00513305|3193112|Superiority or Other||Cox Proportional Hazard|1.027||||0.829|2-Sided|95.0|0.535|1.973|||Log Rank||||
1734340|NCT00513305|3193113|Superiority or Other|||||||0.425||||||The p-value is from the Pearson chi-square test for testing the equality of two binomial proportions, assuming normal approximation of the binomial proportions.|Chi-squared|There were no adjustments for covariates. Since the primary endpoint was prespecified, no adjustment for multiplicity of endpoints was introduced||The hypothesis of equal complete remission rates between the two treatment groups was tested using a 2-sided, normal approximation to the difference in binomial proportions test with two-sided alpha equal to 0.05.|
1734341|NCT00513292|3193122|Superiority or Other||difference in percentages between arms|2.3||||0.7|2-Sided|95.0|-9.3|13.9|||Chi-squared|||The difference in pCR rates between treatment arms for pCR within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy|
1734342|NCT00512278|3193162|Non-Inferiority or Equivalence|Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated.||||||0.718||||||Univariate and multivariable logistic regression were used for factors associated with an SVR.|t-test, 2 sided|||SVR was the primary outcome to calculate sample size. Assuming a 25% difference in the rate of SVR between the the two groups, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated. This analysis included patients randomized and received at least one dose of study drugs. A 2-sided probability value of < 0.05 was considered statistically significant. Univariate and multivariable logistic regression were used for factors associated with an SVR.|
1734343|NCT00512278|3193164|Non-Inferiority or Equivalence|Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated||||||0.718|||||||t-test, 2 sided||||
1734344|NCT00511901|3193189|Superiority or Other||Median Difference (Net)|-1.0||||0.68||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 12 weeks|
1734345|NCT00511901|3193189|Superiority or Other||Median Difference (Net)|-1.0||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 8 weeks|
1734346|NCT00511901|3193189|Superiority or Other||Median Difference (Net)|2.5||||0.97||95.0|||||Wilcoxon (Mann-Whitney)|||POMS at 3 weeks|
1734347|NCT00511901|3193190|Superiority or Other||Mean Difference (Net)|16.15||||0.36||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 12 weeks|
1734348|NCT00511901|3193190|Superiority or Other||Mean Difference (Net)|11.39||||0.69||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 8 weeks|
1734349|NCT00511901|3193190|Superiority or Other||Mean Difference (Net)|-9.57||||0.37||95.0|||||Wilcoxon (Mann-Whitney)|||Activity Counts at 3 weeks|
1734350|NCT00511901|3193191|Superiority or Other||Mean Difference (Net)|-4.1||||0.46||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 12 weeks|
1734351|NCT00511901|3193191|Superiority or Other||Mean Difference (Net)|2.5||||0.83||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 8 weeks|
1734352|NCT00511901|3193191|Superiority or Other||Mean Difference (Net)|-2.6||||0.64||95.0|||||Wilcoxon (Mann-Whitney)|||FACIT at 3 weeks|
1734353|NCT00511901|3193192|Superiority or Other||Mean Difference (Net)|-0.9||||0.66||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 12 weeks|
1734354|NCT00511901|3193192|Superiority or Other||Mean Difference (Net)|0.4||||1||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 8 weeks|
1734355|NCT00511901|3193192|Superiority or Other||Mean Difference (Net)|0.3||||0.96||95.0|||||Wilcoxon (Mann-Whitney)|||SPPB at 3 weeks|
1734356|NCT00511901|3193193|Superiority or Other||Mean Difference (Net)|1.6||||0.53||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 12 weeks|
1734357|NCT00511901|3193193|Superiority or Other||Mean Difference (Net)|0.2||||1||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 8 weeks|
1734358|NCT00511901|3193193|Superiority or Other||Mean Difference (Net)|-0.6||||0.66||95.0|||||Wilcoxon (Mann-Whitney)|||Grip strength at 3 weeks|
1734359|NCT00511901|3193194|Superiority or Other||Mean Difference (Net)|4.3||||0.21||95.0|||||Wilcoxon (Mann-Whitney)||||
1734360|NCT00511901|3193195|Superiority or Other||Mean Difference (Net)|-0.1||||0.59||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 12 weeks|
1734361|NCT00511901|3193195|Superiority or Other||Mean Difference (Net)|3.3||||0.17||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 8 weeks|
1734362|NCT00511901|3193195|Superiority or Other||Mean Difference (Net)|0.8||||1||95.0|||||Wilcoxon (Mann-Whitney)|||FIM at 3 weeks|
1734363|NCT00511901|3193196|Superiority or Other||Mean Difference (Net)|1.7||||0.02||95.0|||||Wilcoxon (Mann-Whitney)||||
1734364|NCT00511875|3193197|Superiority|||||||0.62|||||||t-test, 2 sided||||
1734365|NCT00511875|3193198|Superiority|||||||0.75|||||||t-test, 2 sided||||
1734366|NCT00511875|3193199|Superiority|||||||0.88|||||||t-test, 2 sided||||
1734367|NCT00511875|3193200|Superiority|||||||0.81|||||||t-test, 2 sided||||
1734368|NCT00511875|3193201|Superiority|||||||0.46|||||||t-test, 2 sided||||
1734369|NCT00511875|3193202|Superiority|||||||0.98|||||||t-test, 2 sided||||
1734370|NCT00511875|3193203|Superiority|||||||0.3|||||||t-test, 2 sided|||mean FDP sensitivity|
1734371|NCT00511875|3193203|Superiority|||||||0.02|||||||t-test, 2 sided|||Foveal Sensitivity|
1734372|NCT00511875|3193204|Superiority|||||||0.16|||||||t-test, 2 sided|||Mean field sensitivity|
1734373|NCT00511875|3193204|Superiority|||||||0.33|||||||t-test, 2 sided|||Foveal Sensitivity|
1734374|NCT00511875|3193205|Superiority|||||||0.7|||||||t-test, 2 sided||||
1734375|NCT00511836|3193209|Superiority or Other|||||||0.245|||||||t-test, 1 sided|||Null hypothesis: mean treatment difference=0|
1734378|NCT00511797|3193237|Superiority or Other||Mean Difference (Final Values)|-1.53|Standard Error of the Mean|0.317|<|0.001||95.0|-2.16|-0.9|||t-test, 1 sided||||
1734379|NCT00511797|3193237|Superiority or Other||Mean Difference (Final Values)|-1.34|Standard Error of the Mean|0.306|<|0.001||95.0|-1.95|-0.73|||t-test, 1 sided||||
1734380|NCT00511797|3193237|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.322|<|0.001|2-Sided|95.0|-1.74|-0.46|||t-test, 1 sided|||Test results of 3 mg DRSP and placebo at Cycle 4 are shown. 2-sided 95% confidence intervals were calculated. To keep consistency with 2-sided 95% confidence intervals, 2.5% 1-sided significance levels were used for the statistical tests.|
1734381|NCT00511797|3193238|Superiority or Other||Median Difference (Final Values)|-1.44|Standard Error of the Mean|0.28|<|0.001||95.0|-2.0|-0.89|||t-test, 1 sided|||Third null hypotheses was tested. H03: DRSP 1 mg >= Placebo vs H13: DRSP 1 mg < Placebo.|
1734382|NCT00511797|3193238|Superiority or Other||Median Difference (Final Values)|-1.1|Standard Error of the Mean|0.277|<|0.001||95.0|-1.64|-0.55|||t-test, 1 sided|||Second null hypothesis was tested. H02: DRSP 2 mg >= Placebo vs H12: DRSP 2 mg < Placebo.|
1734383|NCT00511797|3193238|Superiority or Other||Median Difference (Final Values)|-0.92|Standard Error of the Mean|0.29|<|0.001|2-Sided|95.0|-1.49|-0.34||Pre-defined sequential tests were applied to protect alpha inflation by multiplicity.|t-test, 1 sided|||Three null hypotheses were sequentially tested. H01: DRSP 3 mg >= Placebo (Active is equal or less in decrease of score) vs H11: DRSP 3 mg < Placebo (Active is greater in decrease of score), H02: DRSP 2 mg >= Placebo vs H12: DRSP 2 mg < Placebo, H03: DRSP 1 mg >= Placebo vs H13: DRSP 1 mg < Placebo.|
1734384|NCT00511472|3193251|Superiority or Other||Mean Difference (Final Values)|50.28|Standard Error of the Mean|13.67|<|0.001|2-Sided|90.0|27.68|72.88|||ANOVA|||For the least square mean difference - baseline in the ANOVA model = glucose value at Titration Day 1 pre-breakfast for Titration Group 2|
1734385|NCT00511472|3193251|Superiority or Other||Mean Difference (Final Values)|46.1|Standard Error of the Mean|14.15|<|0.001|2-Sided|90.0|22.71|69.5|||ANOVA|||For the least square mean difference - baseline in the ANOVA model = glucose value at Titration Day 1 pre-Breakfast for Titration Group 1|
1734386|NCT00511355|3193283|Superiority or Other||||||<|0.0001||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734387|NCT00511355|3193284|Superiority or Other|||||||0.177||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734388|NCT00511355|3193285|Superiority or Other|||||||0.5668||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734389|NCT00511355|3193286|Superiority or Other||||||<|0.0001||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734390|NCT00511355|3193287|Superiority or Other||||||<|0.0001||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734391|NCT00511355|3193288|Superiority or Other|||||||0.3653||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734392|NCT00511355|3193289|Superiority or Other|||||||0.0024||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734393|NCT00511355|3193290|Superiority or Other|||||||0.0009||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734394|NCT00511355|3193291|Superiority or Other|||||||0.0003||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734395|NCT00511355|3193292|Superiority or Other|||||||0.0016||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734396|NCT00511355|3193293|Superiority or Other|||||||0.0078||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734397|NCT00511355|3193294|Superiority or Other||||||<|0.0001||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734398|NCT00511355|3193295|Superiority or Other||||||<|0.0001||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734399|NCT00511355|3193296|Superiority or Other|||||||0.0063||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734400|NCT00511355|3193297|Superiority or Other|||||||0.0455||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734401|NCT00511355|3193298|Superiority or Other|||||||0.0083||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734402|NCT00511355|3193299|Superiority or Other||||||<|0.0001||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734403|NCT00511355|3193300|Superiority or Other||||||<|0.0001||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734404|NCT00511355|3193301|Superiority or Other|||||||0.6886||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734405|NCT00511355|3193302|Superiority or Other||||||<|0.0001||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734406|NCT00511355|3193303|Superiority or Other|||||||0.0187||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734407|NCT00511355|3193304|Superiority or Other|||||||0.9662||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734408|NCT00511355|3193305|Superiority or Other|||||||0.0019||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734409|NCT00511355|3193306|Superiority or Other|||||||0.0004||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734410|NCT00511355|3193307|Superiority or Other|||||||0.9662||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734411|NCT00511355|3193308|Superiority or Other|||||||0.0041||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734412|NCT00511355|3193309|Superiority or Other|||||||0.5027||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734413|NCT00511355|3193310|Superiority or Other|||||||0.3779||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734414|NCT00511355|3193314|Superiority or Other|||||||0.001||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734415|NCT00511355|3193315|Superiority or Other|||||||0.4191||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734416|NCT00511355|3193316|Superiority or Other||||||<|0.0001||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734417|NCT00511355|3193318|Superiority or Other|||||||0.0849||||||No correction for multiple testing was made.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test adjusted for age class applied on the changes from baseline.||P-value compares the change from baseline to Cycle 6 between treatment groups.|
1734418|NCT00511342|3193326|Superiority or Other||Difference of adjusted means|-0.03||||0.57|2-Sided|95.0|-0.136|0.075||No corrections for multiple comparisons were made for these safety parameters. The a-priori threshold for statistical significance was 0.05.|ANCOVA|The ANCOVA included the Z-score values at baseline as adjusted factor.|NOMAC-E2 minus LNG-EE for femoral neck||
1734419|NCT00511342|3193326|Superiority or Other||Difference of adjusted means|-0.078||||0.19|2-Sided|95.0|-0.198|0.041||No corrections for multiple comparisons were made for these safety parameters. The a-priori threshold for statistical significance was 0.05.|ANCOVA|The ANCOVA included the Z-score values at baseline as adjusted factor.|NOMAC-E2 minus LNG-EE for lumbar spine (L2-L4)||
1734420|NCT00511173|3193351|Superiority or Other||Mean Difference (Final Values)|10.0|Standard Deviation|4.5|<|0.05|2-Sided|95.0|||||t-test, 2 sided|||Null hypothesis: there is no difference in warfarin dose (mg/wk) between pharmacist dosing and algorithm dosing. In order to gather all SNP groups, the power analysis resulted in > 100 patients enrolled into each group.|
1734421|NCT00511134|3193356|Superiority or Other||||||<|0.05|||||||Fisher Exact|Degrees of freedom=1||It is predicted that subjects taking eszopiclone will be more likely to report abstinence at trial endpoint than those taking placebo.|
1734422|NCT00511134|3193357|Superiority or Other||||||<|0.05|||||||Descriptive data|||It was hypothesized that the Zyban+Lunesta group would report lower ISI scores at end of trial than the Zyban+Placebo group.|
1734423|NCT00511108|3193358|Superiority or Other||Mean Difference (Net)|-407.8|||<|0.001||95.0|-513.4|-302.1|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and baseline value as a covariate|||
1734424|NCT00511108|3193359|Superiority or Other||Geometric Mean Difference|73.8|||<|0.001||95.0|44.2|104.4|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and log-scaled baseline value as a covariate|The outcome was analyzed by ANCOVA on the log scale. Results have been back-transformed to the original scale.||
1734425|NCT00511108|3193360|Superiority or Other||Mean Difference (Net)|-29.7||||0.002||95.0|-48.7|-10.6|||ANCOVA|Model terms: treatment, prior diabetes pharmacotherapy (yes or no), and baseline value as a covariate|||
1734428|NCT00510952|3193368|Superiority or Other|||||||0.015|||||||ANCOVA|ANCOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.|||
1734429|NCT00510952|3193369|Superiority or Other|||||||0.031|||||||ANCOVA|ANCOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.|||
1734430|NCT00510952|3193370|Non-Inferiority or Equivalence|Noninferiority margin of 1.5 kilograms (kg).|Mean Difference (Net)|-0.01||||0.975||95.0|-0.61|0.59||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: insulin lispro protamine suspension is noninferior to glargine with regard to change in absolute body weight from baseline to endpoint.|
1734431|NCT00510952|3193372|Superiority or Other|||||||0.102||||||P-value for Severe Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.|||
1734432|NCT00510952|3193372|Superiority or Other||||||<|0.001||||||P-Value for Nocturnal Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.|||
1734433|NCT00510952|3193372|Superiority or Other||||||<|0.316||||||P-value for Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group. Hypoglycemic Rate (1 year) was used.|||
1734434|NCT00510952|3193373|Superiority or Other|||||||0.036||||||P-value for Severe Hypoglycemic Episodes.|Fisher Exact||||
1734435|NCT00510952|3193373|Superiority or Other|||||||0.011||||||P-value for Nocturnal Hypoglycemic Episodes.|Fisher Exact||||
1734436|NCT00510952|3193373|Superiority or Other|||||||0.468||||||P-value for All Hypoglycemic Episodes.|Fisher Exact||||
1734437|NCT00510952|3193374|Superiority or Other|||||||0.609||||||P-value for Daily Mean Morning+Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1734438|NCT00510952|3193374|Superiority or Other|||||||0.394||||||P-value for Daily Mean Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1734439|NCT00510952|3193374|Superiority or Other|||||||0.836||||||P-value for Daily Mean Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1734440|NCT00510952|3193374|Superiority or Other|||||||0.389||||||P-value for Daily Mean 7-Point SMBG.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1734441|NCT00510952|3193374|Superiority or Other|||||||0.316||||||P-value for Actual 0300 Hours.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1734442|NCT00510952|3193374|Superiority or Other|||||||0.875||||||P-value for Actual Evening Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1734443|NCT00510952|3193374|Superiority or Other|||||||0.918||||||P-value for Actual Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1734444|NCT00510952|3193374|Superiority or Other|||||||0.928||||||P-value for Actual Midday Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1734445|NCT00510952|3193374|Superiority or Other|||||||0.279||||||P-value for Actual Midday Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1734446|NCT00510952|3193374|Superiority or Other|||||||0.144||||||P-value for Actual Morning Postprandial Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1734447|NCT00510952|3193374|Superiority or Other|||||||0.302||||||P-value for Actual Morning Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1734448|NCT00510952|3193375|Non-Inferiority or Equivalence|Noninferiority margin of 0.8 millimoles per liter (mmol/L).|Mean Difference (Net)|0.06||||0.323||95.0|-0.06|0.19|||ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatment groups (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: Insulin lispro protamine suspension is noninferior to glargine at actual morning pre-meal at endpoint.|
1734449|NCT00510952|3193376|Superiority or Other|||||||0.504||||||P-value for HbA1c ≤6.5%.|Fisher Exact||||
1734450|NCT00510952|3193376|Superiority or Other|||||||0.634||||||P-value for HbA1c <7.0%.|Fisher Exact||||
1734451|NCT00510952|3193377|Superiority or Other||Mean Difference (Net)|-0.09||||0.254||95.0|-0.25|0.07||P-value for Week 24 Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).||
1734452|NCT00510952|3193377|Superiority or Other||Mean Difference (Net)|-0.09||||0.254||95.0|-0.25|0.07||P-value for Week 24 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).||
1734453|NCT00510952|3193377|Superiority or Other||Mean Difference (Net)|-0.06||||0.427||95.0|-0.21|0.09||P-value for Week 12 Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).||
1734454|NCT00510952|3193377|Superiority or Other||Mean Difference (Net)|-0.06||||0.427||95.0|-0.21|0.09||P-value for Week 12 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).||
1734548|NCT00510146|3193528|Superiority or Other||||||<|0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in prolactin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)||||
1734858|NCT00502853|3194335|Superiority or Other|||||||0.9158|||||||Student's t-test|||Change from Baseline at Week 24|
1734455|NCT00510952|3193378|Non-Inferiority or Equivalence|Noninferiority margin was 0.4%.|Mean Difference (Net)|-0.05||||0.551||95.0|-0.21|0.11||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Glargine).|Hypothesis: Basal analog insulin lispro protamine suspension, injected once or twice daily is noninferior to basal analog insulin glargine, injected once a day, with regard to glycemic control as measured by change in HbA1c from baseline to 24 week endpoint (last observation carried forward).|
1734456|NCT00510744|3193404|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|24.0|<|0.05|2-Sided||||||t-test, 2 sided|||paired changes in fat absorption assessed by parametric (t test) or non-parametric tests (Mann-Whitney)|
1734457|NCT00510692|3193426|Superiority or Other||Mean Difference (Net)|-1.06||||0.005|2-Sided|95.0|-1.78|-0.35|||ANCOVA||||
1734458|NCT00510484|3193432|Superiority or Other||||||<|0.001|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1734459|NCT00510484|3193433|Superiority or Other|||||||0.013|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1734460|NCT00510484|3193434|Superiority or Other||||||<|0.001|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1734461|NCT00510484|3193435|Superiority or Other||||||<|0.001|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1734462|NCT00510484|3193436|Superiority or Other||||||<|0.001|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1734463|NCT00510484|3193437|Superiority or Other||||||<|0.001|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1734464|NCT00510484|3193438|Superiority or Other||||||<|0.001|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1734465|NCT00510484|3193439|Superiority or Other||||||<|0.001|||||||ANOVA|||The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.|
1734466|NCT00510458|3193443|Other|To test if the change from pre-operative LEAS compared to the post-operative LEAS at 5 years is statistically significant.||||||0.0006|||||||t-test, 2 sided||||
1734467|NCT00510458|3193443|Other|To test if the change from pre-operative LEAS compared to the post-operative LEAS at 1 year and 3 years is statistically significant.|||||<|0.0001|||||||t-test, 2 sided||||
1734468|NCT00510458|3193444|Other|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 5 years is statistically significant.||||||0.677|||||||t-test, 2 sided||||
1734469|NCT00510458|3193444|Other|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 3 years is statistically significant.||||||0.4974|||||||t-test, 2 sided||||
1734470|NCT00510458|3193444|Other|To test if the change from pre-operative SF-12 Mental component score compared to the post-operative SF-12 Mental component score at 1 year is statistically significant.||||||0.0394|||||||t-test, 2 sided||||
1734471|NCT00510458|3193444|Other|To test if the change from pre-operative SF-12 Physical component score compared to the post-operative SF-12 Physical component score at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided||||
1734472|NCT00510458|3193445|Other|To test if the change from pre-operative HHS ROM compared to the post-operative HHS ROM at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided||||
1734473|NCT00510458|3193446|Other|To test if the change from pre-operative HHS pain score compared to the post-operative HHS pain score at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided||||
1734474|NCT00510458|3193447|Other|To test if the change from pre-operative HHS compared to the post-operative HHS at all intervals is statistically significant.|||||<|0.0001|||||||t-test, 2 sided||||
1734475|NCT00510458|3193448|Other|It is expected that the mean linear wear rate is not more than 0.08 mm per year or 0.05 mm per year superior to the reference control, which was 0.13 mm per year. The reference control was determined from the control group within the Post-approval Study of the ABC and Trident® Systems (NCT00960206).|mean linear wear rate at 5 yrs|0.008|||||2-Sided|90.0|-0.0107|0.0267|||||||
1734476|NCT00510276|3193454|Superiority or Other|||||||0.482||||||Tested was smoking status across treatment.|Cochran-Mantel-Haenszel|||Tested was the null hypothesis that smoking status is not a predictor of strong response to atomoxetine treatment compared with placebo|
1734477|NCT00510276|3193455|Superiority or Other|||||||0.788|||||||Cochran-Mantel-Haenszel|Tested was smoking status across treatment.||Tested was the null hypothesis that smoking status is not a predictor of response to atomoxetine treatment compared with placebo|
1734478|NCT00510276|3193456|Superiority or Other||Mean Difference (Final Values)|-0.69||||0.065|2-Sided|95.0|-1.42|0.04|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in ESS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734479|NCT00510276|3193457|Superiority or Other||Mean Difference (Final Values)|-1.3|||<|0.001|2-Sided|95.0|-1.98|-0.63|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Working Memory section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734549|NCT00510146|3193529|Superiority or Other||||||<|0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hemoglobin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)||||
1741657|NCT00432809|3203959|Superiority or Other||||||<|0.001|||||||ANOVA||||
1734480|NCT00510276|3193458|Superiority or Other||Mean Difference (Final Values)|-0.71||||0.008|2-Sided|95.0|-1.23|-0.19|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Task Monitor section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734481|NCT00510276|3193459|Superiority or Other||Mean Difference (Final Values)|-0.83||||0.001|2-Sided|95.0|-1.35|-0.32|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Self Monitor Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734482|NCT00510276|3193460|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.045|2-Sided|95.0|-1.04|-0.01|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A SHIFT section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734483|NCT00510276|3193461|Superiority or Other||Mean Difference (Final Values)|-1.34||||0.002|2-Sided|95.0|-2.19|-0.47|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Plan/Organize section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734484|NCT00510276|3193462|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.051|2-Sided|95.0|-1.31|0.0|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Organization of Materials section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734485|NCT00510276|3193463|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.456|2-Sided|95.0|-0.51|0.23|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A negativity section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734486|NCT00510276|3193464|Superiority or Other||Mean Difference (Final Values)|-4.49||||0.003|2-Sided|95.0|-7.43|-1.55|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Metacognition section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734487|NCT00510276|3193465|Superiority or Other||Mean Difference (Final Values)|-0.67||||0.044|2-Sided|95.0|-1.33|-0.02|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Initiate section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734488|NCT00510276|3193466|Superiority or Other||Mean Difference (Final Values)|-0.97||||0.002|2-Sided|95.0|-1.57|-0.37|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inhibit Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734489|NCT00510276|3193467|Superiority or Other||Mean Difference (Final Values)|0.11||||0.097|2-Sided|95.0|-0.02|0.25|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEFS-A infrequency score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734490|NCT00510276|3193468|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.644|2-Sided|95.0|-0.47|0.29|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inconsistency section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734491|NCT00510276|3193469|Superiority or Other||Mean Difference (Final Values)|-7.58||||0.002|2-Sided|95.0|-12.37|-2.78|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A GEC section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734492|NCT00510276|3193470|Superiority or Other||Mean Difference (Final Values)|-0.58||||0.219|2-Sided|95.0|-1.5|0.35|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A emotional control section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734493|NCT00510276|3193471|Superiority or Other||Mean Difference (Final Values)|-2.95||||0.007|2-Sided|95.0|-5.09|-0.81|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Behavioral regulation score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734494|NCT00510276|3193472|Superiority or Other||Mean Difference (Final Values)|0.61||||0.933|2-Sided|95.0|-16.41|17.63|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator||Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Other-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734495|NCT00510276|3193473|Superiority or Other||Mean Difference (Final Values)|-5.06|||<|0.001|2-Sided|95.0|-7.39|-2.72|||Mixed Models Analysis|Adjusted for treatment, investigator, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction.||Tested was the null hypothesis that there is no difference in CAARS-Inv:SV score changes from baseline to 12-week endpoint between the atomoxetine group and the placebo group. With approximately 220 patients per arm, assuming a 68% completion rate and an estimated effect size of atomoxetine over placebo of 0.35, using a 5% significance level, the analysis was expected to have 90% power to detect a difference between atomoxetine and placebo at week 12.|
1734496|NCT00510276|3193474|Superiority or Other||Mean Difference (Final Values)|-1.61||||0.201|2-Sided|95.0|-4.08|0.86|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Self-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734497|NCT00510276|3193475|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.656|2-Sided|95.0|-1.24|0.78|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in SASS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734498|NCT00510276|3193476|Superiority or Other||Mean Difference (Final Values)|-0.31||||0.382|2-Sided|95.0|-1.0|0.39|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in Fagerstorm Test for Nicotine Dependence score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734499|NCT00510276|3193477|Superiority or Other||Mean Difference (Final Values)|0.06||||0.676|2-Sided|95.0|-0.24|0.37|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of marijuana score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734500|NCT00510276|3193478|Superiority or Other||Mean Difference (Final Values)|0.82||||0.233|2-Sided|95.0|-0.53|2.17|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of nicotine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734501|NCT00510276|3193480|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.825|2-Sided|95.0|-0.33|0.26|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of caffeine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734502|NCT00510276|3193481|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.198|2-Sided|95.0|-0.39|0.08|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of alcohol score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734503|NCT00510276|3193482|Superiority or Other||||||<|0.001|||||||Pearson's Correlation Coefficient|||Tested was the null hypothesis that AAQOL-29 total score and CAARS-Inv:SV total score are not correlated.|
1734504|NCT00510276|3193483|Superiority or Other||Mean Difference (Final Values)|-0.51||||0.556|2-Sided|95.0|-2.21|1.19|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in BAI score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734505|NCT00510276|3193484|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.282|2-Sided|95.0|-1.19|0.35|||ANCOVA|ANCOVA model with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in MADRS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734506|NCT00510276|3193485|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.02|2-Sided|95.0|-0.45|-0.04|||ANCOVA|ANCOVA with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in PGI-I scores at 12-week endpoint between atomoxetine and placebo treatment groups.|
1734507|NCT00510276|3193486|Superiority or Other||Mean Difference (Final Values)|-4.04|||<|0.001|2-Sided|95.0|-5.94|-2.15|||Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in CAARS-S:SV score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734508|NCT00510276|3193487|Superiority or Other||Mean Difference (Final Values)|-0.43|||<|0.001|2-Sided|95.0|-0.63|-0.24|||ANCOVA|ANCOVA with terms for baseline score, treatment, and investigator.||Tested was the null hypothesis that there is no statistically significant difference in CGI-ADHD-S score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734509|NCT00510276|3193488|Superiority or Other||Mean Difference (Final Values)|3.4||||0.074|2-Sided|95.0|-0.33|7.12||A gate-keeper strategy was applied to adjust for multiple tests.|ANCOVA|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 life outlook subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734510|NCT00510276|3193489|Superiority or Other||Mean Difference (Final Values)|4.36||||0.034|2-Sided|95.0|0.33|8.39||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 psychological health subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734511|NCT00510276|3193490|Superiority or Other||Mean Difference (Final Values)|5.73||||0.018|2-Sided|95.0|1.0|10.46||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734512|NCT00510276|3193491|Superiority or Other||Mean Difference (Final Values)|5.9||||0.006|2-Sided|95.0|1.68|10.12||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734513|NCT00510276|3193492|Superiority or Other||Mean Difference (Final Values)|4.82||||0.005|2-Sided|95.0|1.44|8.2||A gate-keeper strategy was applied to adjust for multiple tests.|Mixed Models Analysis|||Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.|
1734514|NCT00510198|3193499|Non-Inferiority or Equivalence|Pre-specified non-inferiority margin was 7.5%|Risk Difference (RD)|4.7||||0.36|2-Sided|95.0|-10.9|20.3||The study was terminated early due to enrollment significantly below protocol expectation. Due to the low sample size and consequently low statistical power, no conclusion can be drawn.|Two-sample test of proportions||The risk difference estimate is the difference between the Access Arm and Control arm.||
1734608|NCT00509392|3193635|Superiority or Other|||||||0.0044|||||||t-test, 2 sided||||
1734515|NCT00510198|3193500|Superiority or Other|||||||0.23||||||The log-rank test was conducted at an alpha level of 0.05. The study was terminated early due to enrollment significantly below protocol expectation. Due to the low sample size and consequently low statistical power, no conclusion can be drawn.|Log Rank|||This is a log-rank test, which uses the time from randomization to first composite endpoint event to compare the risk of event between Access and Control arms.|
1734516|NCT00510146|3193503|Superiority or Other|||||||0.919||||||p-value represents change from baseline to endpoint for heart rate from t-test.|t-test, 2 sided||||
1734517|NCT00510146|3193504|Superiority or Other|||||||0.044||||||p-value represents change from baseline to endpoint for QTcB from t-test.|t-test, 2 sided||||
1734518|NCT00510146|3193504|Superiority or Other|||||||0.023||||||p-value represents change from baseline to endpoint for QTcF from t-test.|t-test, 2 sided||||
1734519|NCT00510146|3193505|Superiority or Other||||||<|0.001||||||p-value represents change from baseline to endpoint for HDL cholesterol from t-tests on change.|t-test, 2 sided||||
1734520|NCT00510146|3193505|Superiority or Other||||||<|0.049||||||p-value represents change from baseline to endpoint for LDL cholesterol from t-tests on change.|t-test, 2 sided||||
1734521|NCT00510146|3193505|Superiority or Other||||||<|0.055||||||p-value represents change from baseline to endpoint for triglycerides from t-tests on change.|t-test, 2 sided||||
1734522|NCT00510146|3193505|Superiority or Other||||||<|0.13||||||p-value represents change from baseline to endpoint for cholesterol from t-tests on change.|t-test, 2 sided||||
1734523|NCT00510146|3193505|Superiority or Other||||||<|0.047||||||p-value represents change from baseline to endpoint for fasting glucose from t-tests on change.|t-test, 2 sided||||
1734524|NCT00510146|3193506|Superiority or Other||||||<|0.001||||||p-value represents change from baseline to endpoint for uric acid from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)||||
1734525|NCT00510146|3193507|Superiority or Other||||||<|0.001||||||p-value represents change from baseline to endpoint for prolactin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)||||
1734526|NCT00510146|3193508|Superiority or Other|||||||0.024||||||p-value represents change from baseline to endpoint for platelet count from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)||||
1734527|NCT00510146|3193509|Superiority or Other|||||||0.035||||||p-value represents change from baseline to endpoint for hemoglobin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)||||
1734528|NCT00510146|3193510|Superiority or Other|||||||0.021||||||p-value represents change from baseline to endpoint for erythrocyte count from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)||||
1734529|NCT00510146|3193511|Superiority or Other||||||<|0.001||||||p-value represents change from baseline to endpoint for creatinine from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)||||
1734530|NCT00510146|3193512|Superiority or Other|||||||0.01||||||p-value represents change from baseline to endpoint for chlorine from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)||||
1734531|NCT00510146|3193513|Superiority or Other|||||||0.354||||||p-value represents change from baseline to endpoint for GGT from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)||||
1734532|NCT00510146|3193513|Superiority or Other|||||||0.01||||||p-value represents change from baseline to endpoint for CPK from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)||||
1734533|NCT00510146|3193513|Superiority or Other|||||||0.002||||||p-value represents change from baseline to endpoint for alkaline phosphatase from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)||||
1734534|NCT00510146|3193514|Superiority or Other|||||||0.002||||||p-value represents change from baseline to endpoint for total protein from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)||||
1734535|NCT00510146|3193514|Superiority or Other||||||<|0.001||||||p-value represents change from baseline to endpoint for albumin from Wilcoxon's signed-rank test.|Wilcoxon (Mann-Whitney)||||
1734536|NCT00510146|3193515|Superiority or Other||||||<|0.001||||||p-value represents change from baseline to endpoint for weight from t-tests on change.|t-test, 2 sided||||
1734537|NCT00510146|3193516|Superiority or Other|||||||0.122||||||p-value represents change from baseline to endpoint-orthostatic change in systolic blood pressure from t-tests on change.|t-test, 2 sided||||
1734538|NCT00510146|3193516|Superiority or Other|||||||0.64||||||p-value represents change from baseline to endpoint-orthostatic change in diastolic blood pressure from t-tests on change.|t-test, 2 sided||||
1734539|NCT00510146|3193516|Superiority or Other|||||||0.612||||||p-value represents change from baseline to endpoint-sitting systolic blood pressure from t-tests on change.|t-test, 2 sided||||
1734540|NCT00510146|3193516|Superiority or Other|||||||0.08||||||p-value represents change from baseline to endpoint-standing systolic blood pressure from t-tests on change.|t-test, 2 sided||||
1734541|NCT00510146|3193516|Superiority or Other|||||||0.944||||||p-value represents change from baseline to endpoint-sitting diastolic blood pressure from t-tests on change.|t-test, 2 sided||||
1734542|NCT00510146|3193516|Superiority or Other|||||||0.736||||||p-value represents change from baseline to endpoint-standing diastolic blood pressure from t-tests on change.|t-test, 2 sided||||
1734543|NCT00510146|3193524|Superiority or Other||Mean Difference (Final Values)|0.02||||0.943|2-Sided|95.0|-0.59|0.64||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint for MINI Suicidality Total Score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734544|NCT00510146|3193525|Superiority or Other|||||||0.035||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in heart rate from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734545|NCT00510146|3193526|Superiority or Other|||||||0.006||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in QTcB interval from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734546|NCT00510146|3193526|Superiority or Other|||||||0.104||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in QTcF interval from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734547|NCT00510146|3193527|Superiority or Other||||||<|0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in urinalysis-specific gravity from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)||||
1734550|NCT00510146|3193530|Superiority or Other|||||||0.009||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hemoglobin A1c from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)||||
1734551|NCT00510146|3193531|Superiority or Other|||||||0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in hematocrit from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)||||
1734552|NCT00510146|3193532|Superiority or Other|||||||0.003||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in erythrocyte count from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)||||
1734553|NCT00510146|3193533|Superiority or Other||||||<|0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in uric acid from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)||||
1734554|NCT00510146|3193533|Superiority or Other||||||<|0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in total bilirubin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)||||
1734555|NCT00510146|3193533|Superiority or Other||||||<|0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in direct bilirubin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)||||
1734556|NCT00510146|3193534|Superiority or Other||||||<|0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in GGT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)||||
1734557|NCT00510146|3193534|Superiority or Other||||||<|0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in AST/SGOT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)||||
1734558|NCT00510146|3193534|Superiority or Other||||||<|0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in ALT/SGPT from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)||||
1734559|NCT00510146|3193535|Superiority or Other|||||||0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in albumin from Wilcoxon's rank-sum test.|Wilcoxon (Mann-Whitney)||||
1734560|NCT00510146|3193536|Superiority or Other|||||||0.095||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in HDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734561|NCT00510146|3193536|Superiority or Other||||||<|0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in LDL cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734562|NCT00510146|3193536|Superiority or Other||||||<|0.003||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in triglycerides from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734563|NCT00510146|3193536|Superiority or Other||||||<|0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in cholesterol from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734564|NCT00510146|3193536|Superiority or Other||||||<|0.179||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in fasting glucose from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734565|NCT00510146|3193537|Superiority or Other||||||<|0.001||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-in weight from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734566|NCT00510146|3193538|Superiority or Other|||||||0.067||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734567|NCT00510146|3193538|Superiority or Other|||||||0.284||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-orthostatic change in systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734568|NCT00510146|3193538|Superiority or Other|||||||0.271||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734569|NCT00510146|3193538|Superiority or Other|||||||0.146||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-standing diastolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734570|NCT00510146|3193538|Superiority or Other|||||||0.249||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-sitting systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734571|NCT00510146|3193538|Superiority or Other|||||||0.146||||||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint-standing systolic blood pressure from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734572|NCT00510146|3193539|Superiority or Other|||||||0.736||||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with EPS symptoms (parkinsonism) at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel||||
1734573|NCT00510146|3193539|Superiority or Other|||||||0.269||||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with EPS symptoms (akathisia) at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel||||
1734574|NCT00510146|3193540|Superiority or Other|||||||0.031||||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with emergence of mania at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel||||
1734575|NCT00510146|3193542|Superiority or Other|||||||0.324||||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current alcohol abuse from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel||||
1734576|NCT00510146|3193542|Superiority or Other|||||||1||||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current alcohol dependence from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel||||
1734577|NCT00510146|3193543|Superiority or Other|||||||0.442||||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current mood disorders with psychotic features from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel||||
1734578|NCT00510146|3193543|Superiority or Other|||||||0.163||||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current psychotic disorders from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel||||
1734579|NCT00510146|3193544|Superiority or Other|||||||0.195||||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with current hypomanic episode from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel||||
1734580|NCT00510146|3193545|Superiority or Other|||||||0.264||||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with major depressive episode with melancholic features from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel||||
1734581|NCT00510146|3193545|Superiority or Other|||||||0.297||||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with major depressive episode from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel||||
1734582|NCT00510146|3193546|Superiority or Other||Mean Difference (Final Values)|-2.21||||0.002|2-Sided|95.0|-3.61|-0.81||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734583|NCT00510146|3193547|Superiority or Other||Mean Difference (Final Values)|-0.99|||<|0.001|2-Sided|95.0|-1.56|-0.43||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734584|NCT00510146|3193548|Superiority or Other|||||||0.156||||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with recovery from a Cochran-Mantel-Haenszel test using region as strata.|Cochran-Mantel-Haenszel||||
1734585|NCT00510146|3193549|Superiority or Other||Median Difference (Final Values)|-0.3||||0.008|2-Sided|95.0|-0.53|-0.08||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Overall score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734586|NCT00510146|3193549|Superiority or Other||Median Difference (Final Values)|-0.24||||0.037|2-Sided|95.0|-0.47|-0.01||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Depression score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734587|NCT00510146|3193549|Superiority or Other||Median Difference (Final Values)|-0.11||||0.008|2-Sided|95.0|-0.2|-0.03||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in CGI-BP Mania score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734588|NCT00510146|3193550|Superiority or Other|||||||0.367||||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with symptomatic remission at any time from a Cochran-Mantel-Haenszel test using region as strata.|Cochran-Mantel-Haenszel||||
1734589|NCT00510146|3193551|Superiority or Other|||||||0.05||||||p-value represents a comparison of the olanzapine and placebo groups in percentage of participants with symptomatic response at endpoint from a Cochran-Mantel-Haenszel test using geographic region as strata.|Cochran-Mantel-Haenszel||||
1734590|NCT00510146|3193552|Superiority or Other||Mean Difference (Final Values)|-2.15||||0.018|2-Sided|95.0|-3.93|-0.36||p-value represents a comparison of the olanzapine and placebo groups in change from baseline to endpoint in MADRS total score from the following ANCOVA model: Change=Treatment+Baseline+Geographic Region.|ANCOVA||||
1734591|NCT00509795|3193606|Superiority or Other||Differences in Least Squares means|0.86||||0.0173|2-Sided|95.1|0.15|1.58||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q8|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.|
1734592|NCT00509795|3193606|Superiority or Other||Differences in Least Squares means|0.71||||0.0507|2-Sided|95.1|-0.01|1.42||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 0.5Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.|
1734593|NCT00509795|3193606|Superiority or Other||Differences in Least Squares means|-0.33||||0.3575|2-Sided|95.1|-1.04|0.38||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A negative value favors IAI 2.0Q4|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.|
1734594|NCT00509795|3193607|Superiority or Other||Differences in Least Squares means|-0.6||||0.5579|2-Sided|95.1|-2.61|1.42||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.|
1734609|NCT00509392|3193636|Superiority or Other|||||||0.0854|||||||t-test, 2 sided||||
1734610|NCT00509392|3193637|Superiority or Other|||||||0.2825|||||||t-test, 2 sided||||
1734611|NCT00509392|3193638|Superiority or Other|||||||0.0035|||||||t-test, 2 sided||||
1734595|NCT00509795|3193607|Superiority or Other||Differences in Least Squares means|-0.67||||0.5128|2-Sided|95.1|-2.69|1.35||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.|
1734596|NCT00509795|3193607|Superiority or Other||Differences Least Squares means|1.28||||0.209|2-Sided|95.1|-0.73|3.28||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.|
1734597|NCT00509795|3193608|Superiority or Other||Risk Difference (RD)|-0.4||||0.93|2-Sided|95.1|-7.7|7.0||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as VEGF Trap-Eye minus ranibizumab. A positive value favors VEGF Trap-Eye 2.0Q8.|The pairwise The null hypothesis is that both percentages are equal.|
1734598|NCT00509795|3193608|Superiority or Other||Risk Difference (RD)|-6.0||||0.1037|2-Sided|95.1|-13.2|1.2||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The null hypothesis is that both percentages are equal.|
1734599|NCT00509795|3193608|Superiority or Other||Risk Difference (RD)|6.6||||0.1042|2-Sided|95.1|-1.0|14.1||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049.|Chi-squared||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The null hypothesis is that both percentages are equal.|
1734600|NCT00509795|3193609|Superiority or Other||Differences in Least Squares Means|0.26||||0.8179|2-Sided|95.1|-1.97|2.49||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q8.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.|
1734601|NCT00509795|3193609|Superiority or Other||Differences in Least Squares means|0.8||||0.4793|2-Sided|95.1|-3.03|1.43||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 0.5Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.|
1734602|NCT00509795|3193609|Superiority or Other||Differences in Least Squares means|3.15||||0.0054|2-Sided|95.1|0.92|5.37||As adjustment of multiple comparisons, a conditional sequence of statistical hypotheses is used with alpha = 0.049|ANCOVA||The difference is calculated as IAI minus ranibizumab. A positive value favors IAI 2.0Q4.|The pairwise comparison is performed as contrast statement in the analysis of covariance model with treatment group as fixed factor (all 4 treatment groups) and the baseline measure as covariate. The null hypothesis is that both mean changes are equal.|
1734603|NCT00509795|3193610|Non-Inferiority or Equivalence|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-0.7|||||2-Sided|95.1|-4.5|3.1|||||The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 2.0Q8 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).|
1734604|NCT00509795|3193610|Non-Inferiority or Equivalence|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-1.5|||||2-Sided|95.1|-5.1|2.1|||||The difference is calculated as ranibizumab minus IAI. A negative value favors the IAI 0.5Q4 group. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI (EYLEA, VEGF Trap-Eye).|
1734605|NCT00509795|3193610|Non-Inferiority or Equivalence|The non-inferiority margin was set at 10%. The power is 90% according to the sample size estimation of the study protocol. Although not in the analysis plan for the study, in a separate communication, the FDA further explained that, whereas the 10% non-inferiority margin would be used to assess non-inferiority, a 5% non-inferiority margin would be used to assess clinical equivalence.|Risk Difference (RD)|-0.7|||||2-Sided|95.1|-4.4|3.1|||||The difference is calculated as ranibizumab minus IAI. A positive value favors IAI 2.0Q4. As adjustment of multiple comparisons as conditional sequence of statistical hypotheses is used with alpha = 0.049.|The statistical approach included a conditional sequence of calculations of the 95.1% CI using normal approximation of the difference between the proportion of patients with maintained vision at Week 52 for the group treated with 0.5 mg ranibizumab and the proportion of patients with maintained vision for each of the groups treated with IAI.|
1734606|NCT00509392|3193633|Superiority or Other|||||||0.9463|||||||t-test, 2 sided||||
1734607|NCT00509392|3193634|Superiority or Other|||||||0.0457|||||||t-test, 2 sided||||
1734626|NCT00509262|3193660|Superiority or Other||Difference in least squares mean|-1.8|Standard Deviation|3.8|<|0.001|2-Sided|95.0|-2.6|-1.0|||ANCOVA||Analysis of covariance with terms of treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline body weight.||
1734627|NCT00509262|3193661|Superiority or Other||Difference in least squares mean|7.1|Standard Deviation|38.3|||2-Sided|95.0|-1.9|16.1|||||Analysis of covariance with terms for treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline Fasting Plasma Glucose.||
1734628|NCT00509262|3193662|Superiority or Other||Mean Difference (Final Values)|-10.8||||0.001|2-Sided|95.0|-17.1|-4.8|||Miettirnen& Nurminen method||Miettirnen & Nurminen method stratified by renal insufficiency stratum at Visit 4/Week -2 (moderate or severe) & prior diabetes pharmacotherapy||
1734629|NCT00509262|3193663|Non-Inferiority or Equivalence|The pre-specified non-inferiority margin was 0.4%; i.e., non-inferiority required that the upper boundary of the 95% confidence interval for the treatment difference (sitagliptin minus glipizide) to be less than 0.4%.|Difference in least squares mean|-0.11|Standard Deviation|0.74|||2-Sided|95.0|-0.29|0.06|||||Based on analysis of covariance with terms for treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate, or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline A1C.||
1734630|NCT00509236|3193665|Superiority or Other||Difference in LS Means|0.15|||||2-Sided|95.0|-0.18|0.49||||||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline A1c.|
1734631|NCT00509236|3193666|Superiority or Other||Difference in LS Means|4.6|||||2-Sided|95.0|-11.5|20.7||||||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.|
1734632|NCT00509236|3193666|Superiority or Other||Change from Baseline in LS Mean|-31.2|||<|0.001|2-Sided|95.0|-42.6|-19.9|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.|
1734633|NCT00509236|3193666|Superiority or Other||Change from Baseline in LS Mean|-26.6|||<|0.001|2-Sided|95.0|-38.0|-15.3|||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline FPG.|
1734634|NCT00509236|3193667|Superiority or Other||Difference in % Affected|2.8|||||2-Sided|95.0|-10.9|16.5|||||||
1734635|NCT00509236|3193668|Superiority or Other||Difference in % Affected|-4.8||||0.336|2-Sided|95.0|-15.7|5.6||Miettinen & Nurminen method stratified by prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent).|Miettinen & Nurminen||||
1734636|NCT00509236|3193669|Superiority or Other||||||<|0.001|||||||ANCOVA|||Model terms: treatment, prior diabetes pharmacotherapy (not on oral antihyperglycemic agent, or on oral antihyperglycemic agent), and a covariate for baseline A1c.|
1734637|NCT00509106|3193684|Non-Inferiority or Equivalence|A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on the MITTE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than –10% for the MITTE populations.|Risk Difference (RD)|5.9|||||2-Sided|95.0|-1.0|12.7|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared with that for ceftriaxone at TOC in the MITTE Population in adult subjects with CABP.|
1734638|NCT00509067|3193691|Superiority|||||||0.23||||||alpha set at P<0.05|Mixed Models Analysis|Time (0, 8, 16, weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48.|||
1734639|NCT00509067|3193691|Superiority|||||||0.23||||||alpha level set at .05|Mixed Models Analysis|Time (0, 8, 16 weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48..|||
1734640|NCT00509067|3193692|Superiority|||||||0.93||||||alpha set at P < .05|Mixed Models Analysis|Time (0, 4, 8, 12, 16 wks) x Treatment (Drug, Placebo) Effect: F(1, 33)=0.01.|||
1734641|NCT00508742|3193720|Superiority or Other||Odds Ratio (OR)|0.5|||||2-Sided|95.0|0.4|0.8||||||Month 24: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.|
1734642|NCT00508742|3193720|Superiority or Other||Odds Ratio (OR)|0.5|||||2-Sided|95.0|0.4|0.7||||||Month 18: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.|
1734643|NCT00508742|3193720|Superiority or Other||Odds Ratio (OR)|0.4|||||2-Sided|95.0|0.3|0.5||||||Month 13: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.|
1734644|NCT00508742|3193720|Superiority or Other||Odds Ratio (OR)|0.6|||||2-Sided|95.0|0.4|0.7||||||Month 12: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.|
1734645|NCT00508742|3193720|Superiority or Other||Odds Ratio (OR)|0.6|||||2-Sided|95.0|0.5|0.9||||||Month 7: 13vPnC/7vPnC, odds ratio was calculated using a logistic regression model with treatment group as the independent variable.|
1734646|NCT00508742|3193721|Superiority or Other||Rate Ratio|0.56|||||2-Sided|95.0|0.47|0.65|||||||
1734647|NCT00508521|3193758|Superiority or Other||Mean Difference (Final Values)|-20.75|Standard Error of the Mean|0.47871||0.0001|2-Sided|95.0|-22.27348|-19.22652|||t-test, 2 sided|||This was a feasibility study. Pre and post treatment analysis was performed for the study participants.|
1734648|NCT00508482|3193759|Superiority or Other|||||||0.008||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared||||
1734649|NCT00508482|3193759|Superiority or Other|||||||0.005||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared||||
1734650|NCT00508482|3193759|Superiority or Other|||||||0.507||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared||||
1734651|NCT00508482|3193759|Superiority or Other|||||||0.006|||||||Chi-squared||||
1734652|NCT00508482|3193760|Superiority or Other||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared||||
1734653|NCT00508482|3193760|Superiority or Other||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared||||
1734654|NCT00508482|3193760|Superiority or Other||||||<|0.587||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared||||
1734655|NCT00508482|3193760|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1734656|NCT00508482|3193761|Superiority or Other||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared||||
1734657|NCT00508482|3193761|Superiority or Other||||||<|0.001||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared||||
1734658|NCT00508482|3193761|Superiority or Other||||||<|0.627||||||α was corrected by the method of Bonferroni as 0.0167 (α=0.05/3=0.0167).|Chi-squared||||
1734659|NCT00508482|3193761|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1734660|NCT00508482|3193762|Superiority or Other||||||<|0.001|||||||Least-Significant Difference||||
1734661|NCT00508482|3193762|Superiority or Other||||||<|0.001|||||||Least-Significant Difference||||
1734662|NCT00508482|3193762|Superiority or Other||||||<|0.024|||||||Least-Significant Difference||||
1734663|NCT00508482|3193762|Superiority or Other||||||<|0.001|||||||ANOVA||||
1734664|NCT00508482|3193763|Superiority or Other|||||||0.066|||||||Kruskal-Wallis||||
1734665|NCT00508482|3193764|Superiority or Other|||||||0.167|||||||ANOVA||||
1734666|NCT00508482|3193765|Superiority or Other||||||<|0.001|||||||Least-Significant Difference||||
1734667|NCT00508482|3193765|Superiority or Other||||||<|0.001|||||||Least-Significant Difference||||
1734668|NCT00508482|3193765|Superiority or Other||||||<|0.58|||||||Least-Significant Difference||||
1734669|NCT00508482|3193765|Superiority or Other||||||<|0.001|||||||ANOVA||||
1734670|NCT00508482|3193766|Superiority or Other|||||||0.271|||||||Kruskal-Wallis||||
1734671|NCT00508482|3193767|Superiority or Other|||||||0.573|||||||ANOVA||||
1734672|NCT00508482|3193768|Superiority or Other|||||||0.018|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up|
1734673|NCT00508482|3193768|Superiority or Other||||||<|0.001|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up|
1734674|NCT00508482|3193768|Superiority or Other||||||<|0.33|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 12th week of follow-up|
1734675|NCT00508482|3193768|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||Comparison among three groups at the 12th week of follow-up|
1734676|NCT00508482|3193768|Superiority or Other||||||<|0.055|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up|
1734677|NCT00508482|3193768|Superiority or Other||||||<|0.001|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up|
1734678|NCT00508482|3193768|Superiority or Other||||||<|0.277|||||||Least-Significant Difference|We translated the data of three groups through rank cases, so that we can use Least-Significant Difference for the comparison of any two groups.||at the 4th week of follow-up|
1734679|NCT00508482|3193768|Superiority or Other||||||<|0.004|||||||Kruskal-Wallis|||Comparison among three groups at the 4th week of follow-up|
1734680|NCT00508482|3193768|Superiority or Other||||||<|0.238|||||||Kruskal-Wallis|||Comparison among three groups over 4 weeks of treatment|
1734681|NCT00508404|3193770|Superiority or Other (legacy)||Difference in rates|8.34|||||2-Sided|95.0|-4.01|19.08|||||||
1734682|NCT00508404|3193772|Superiority or Other (legacy)||Hazard Ratio (HR)|0.71|||||2-Sided|95.0|0.503|1.002|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value < 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.||
1734683|NCT00508404|3193773|Superiority or Other (legacy)||Hazard Ratio (HR)|0.756|||||2-Sided|95.0|0.4|1.43|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value < 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.||
1734684|NCT00508404|3193774|Superiority or Other (legacy)||Hazard Ratio (HR)|0.395|||||2-Sided|95.0|0.252|0.618|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value < 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.||
1734685|NCT00508404|3193775|Superiority or Other (legacy)||Hazard Ratio (HR)|0.464|||||2-Sided|95.0|0.306|0.703|||||Hazard ratio presented as Wild-type KRAS:Mutant KRAS. A value < 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.||
1734686|NCT00508404|3193776|Superiority or Other (legacy)||Hazard Ratio (HR)|1.642|||||2-Sided|95.0|0.99|2.721|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value < 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.||
1734687|NCT00508404|3193777|Superiority or Other (legacy)||Hazard Ratio (HR)|0.283|||||2-Sided|95.0|0.13|0.614|||||Hazard ratio is presented as Wild-type KRAS:Mutant KRAS. A value < 1.0 indicates a lower average event rate and longer time to event for Wild-type KRAS relative to Mutant KRAS.||
1734688|NCT00508404|3193778|Superiority or Other (legacy)||Odds Ratio (OR)|1.11|||||2-Sided|95.0|0.3|3.89|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.||
1734689|NCT00508404|3193779|Superiority or Other (legacy)||Odds Ratio (OR)|1.86|||||2-Sided|95.0|0.88|3.93|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.||
1734690|NCT00508404|3193780|Superiority or Other (legacy)||Odds Ratio (OR)|2.12|||||2-Sided|95.0|1.02|4.45|||||The odds ratio is defined as the odds of having an objective response in the KRAS Wild-type group relative to the odds in the KRAS Mutant group.||
1734859|NCT00502853|3194335|Superiority or Other|||||||0.3358|||||||Student's t-test|||Change from Baseline at Week 4|
1734691|NCT00508391|3193781|Non-Inferiority or Equivalence|The non-inferiority hypothesis has a one-sided Type I error of 0.05 with an 80% statistical power.|Objective Performance Criteria|100.0|||||1-Sided|95.0|97.6|||||||Safety will be evaluated in a non-inferiority format. The null hypothesis is the percent of subjects that did not experience an adverse event with an active interventricular delay feature at two months is inferior to 90% with a clinically significant difference of 10%|
1734692|NCT00508391|3193782|Non-Inferiority or Equivalence|The non-inferiority hypothesis utilized an objective performance criteria of 63% with a clinically significant difference of 12%. For the non-inferiority hypothesis, the one-sided Type I error was set to 0.05 and the statistical power was set to 80%.|Objective Performance Criteria|63.0|||||1-Sided|95.0|54.8|||||||"Efficacy was assessed in a non-inferiority, responder classification design where the proportion of total subjects classified as not worsened after changing from optimized to simultaneous biventricular pacing was compared to an objective performance criteria.~An effect of gender analysis was performed on the primary efficacy endpoint to compare the proportion of males and females classified as not worsened after changing from optimized to simultaneous biventricular pacing."|
1734693|NCT00508274|3193787|Superiority or Other (legacy)||25th percentile|1.38||||||95.0|||||||1.38 is the estimated value for the 25th percentile. The PFS curve didn’t reach the 75th percentile on data cut-off, so no data are available.||
1734694|NCT00508274|3193789|Superiority or Other (legacy)||25th percentile|4.01||||||95.0|||||||4.01 is the estimated value for the 25th percentile. The PFS curve didn’t reach the 75th percentile on data cut-off, so no data are available.||
1734695|NCT00508261|3193816|Non-Inferiority|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentage of subjects with anti-PRP concentrations (ELISA) ≥1.0 μg/mL is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.19|||||2-Sided|95.0|-1.45|4.5|||||||
1734696|NCT00508261|3193817|Non-Inferiority|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided standardized asymptotic 95% CI for the group difference in the percentages of subjects with anti-HBs antibody concentrations ≥10 mIU/ml is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.22|||||2-Sided|95.0|-1.47|4.6|||||||
1734697|NCT00508261|3193818|Non-Inferiority|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PRN (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.92|||||2-Sided|95.0|0.78|1.1||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertactin (PRN), at month 1.|
1734698|NCT00508261|3193818|Non-Inferiority|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-FHA (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.98|||||2-Sided|95.0|0.85|1.13||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to filamentous haemagglutinin (FHA), at month 1.|
1734699|NCT00508261|3193818|Non-Inferiority|Criterion for non-inferiority (1 month after the first study vaccination): The lower limit of the two-sided 95% CI on the GMC ratio for anti-PT (ELISA) is greater than or equal to a pre-defined clinical limit of delta = 0.67.|Adjusted GMC ratios|0.97|||||2-Sided|95.0|0.83|1.12||||||Demonstration of non-inferiority of combined Infanrix-hexa vaccine co-administered with Nimenrix vaccine to Infanrix-hexa vaccine given alone in terms of geometric mean concentrations (GMCs) of antibodies to pertussis toxoid (PT), at month 1.|
1734700|NCT00508261|3193819|Non-Inferiority|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|2.7|||||2-Sided|95.0|0.71|6.18||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup Y, at month 1.|
1734701|NCT00508261|3193819|Non-Inferiority|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.61|||||2-Sided|95.0|-0.36|4.64||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup W-135, at month 1.|
1734702|NCT00508261|3193819|Non-Inferiority|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|2.73|||||2-Sided|95.0|0.73|6.24||||||Demonstration of the non-inferiority of the Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup C, at month 1.|
1734703|NCT00508261|3193819|Non-Inferiority|Criterion for non-inferiority: The lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference in the percentages of subjects with serum bactericidal antibodies using baby rabbit complement (rSBA) titer ≥1:8 is greater than or equal to the pre-defined clinical limit of -10%.|Difference in percentages|1.64|||||2-Sided|95.0|-0.33|4.71||||||Demonstration of the non-inferiority of Nimenrix vaccine co-administered with combined Infanrix-hexa vaccine given alone in terms of bactericidal antibodies to Neisseria meningitidis serogroup A, at month 1.|
1734704|NCT00508183|3193823|Other|||||||0.05|||||||Chi-squared||||
1734705|NCT00508183|3193825|Other|||||||0.05|||||||t-test, 2 sided||||
1734706|NCT00508183|3193826|Other|||||||0.05|||||||t-test, 2 sided||||
1734707|NCT00508183|3193827|Other|||||||0.6|||||||t-test, 2 sided||||
1734708|NCT00508157|3193835|Superiority or Other||Risk Ratio (RR)|0.76|||||2-Sided|95.0|0.54|1.06||||||null hypothesis: no difference between Aripiprazole and Control Group|
1734709|NCT00508157|3193836|Superiority or Other||Mean Difference (Final Values)|-11.28|||||2-Sided|95.0|-19.14|-2.66|||||Relative difference of Aripiprazole vs. Control Group in terms of (mean % change from baseline/100)+1.|Null hypothesis: no difference in mean percent change from baseline in fasting non-HDLC between aripiprazole and the control group at Week 16|
1734710|NCT00508027|3193859|Superiority or Other||Mean Difference (Final Values)|5.5|Standard Deviation|1.7|<|0.05|||||||t-test, 2 sided|||Ho: There is no change in plasma biomarker levels before and after simivastatin treatment. With 12 patients in each group and assuming a 5% risk of Type I error (two-tailed α = 0.05) and estimated SD for the change in NOx (or sVCAM-1) of 48%, power will be 80% to detect a 40% change from baseline for each group, and a 55% difference in the change in biomarker levels between dose groups. Matched paired t-tests were used to measure changes in biomarker levels from baseline.|
1734711|NCT00507819|3193864|Superiority or Other|||||||0.04|||||||Regression, Linear||||
1734712|NCT00507819|3193865|Superiority or Other|||||||0.05|||||||Regression, Linear||||
1734713|NCT00507819|3193866|Superiority or Other|||||||0.37|||||||Regression, Linear||||
1734714|NCT00507819|3193867|Superiority or Other|||||||0.73|||||||Regression, Linear||||
1734715|NCT00507559|3193883|Superiority or Other||||||<|0.001|||||||Fisher Exact|||This is compared to a historical control group, in which 11.1% of subjects experienced one or more MAE within 30 days.|
1734716|NCT00507546|3193885|Superiority or Other|||||||0.35|||||||Friedman||||
1734717|NCT00507546|3193886|Superiority or Other|||||||0.7|||||||Friedman||||
1734718|NCT00507507|3193890|Superiority or Other|||||||0.244||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734719|NCT00507507|3193890|Superiority or Other|||||||0.119||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734720|NCT00507507|3193890|Superiority or Other|||||||0.496||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with seroconversion to anti-HBe between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734721|NCT00507507|3193891|Superiority or Other|||||||0.365||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734722|NCT00507507|3193891|Superiority or Other|||||||0.119||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734723|NCT00507507|3193891|Superiority or Other|||||||0.496||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBeAg loss between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734724|NCT00507507|3193892|Superiority or Other|||||||0.451||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734725|NCT00507507|3193892|Superiority or Other|||||||0.529||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734726|NCT00507507|3193892|Superiority or Other|||||||1||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734727|NCT00507507|3193892|Superiority or Other|||||||0.467||||||A Fisher exact test with a 0.05 two-sided significance level was used, with no adjustments for covariates.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with normal ALT at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734728|NCT00507507|3193893|Superiority or Other|||||||0.07||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734729|NCT00507507|3193894|Superiority or Other|||||||0.186||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734730|NCT00507507|3193895|Superiority or Other|||||||0.019||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734731|NCT00507507|3193896|Superiority or Other|||||||0.01||||||A Wilcoxon rank-sum (2-sided) test was used, with no adjustments for covariates.|Wilcoxon (Mann-Whitney)|||The null hypothesis was that there was no difference of change in HBV DNA from baseline between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734732|NCT00507507|3193897|Superiority or Other|||||||0.007||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 192: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA < 169 copies/mL at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734733|NCT00507507|3193897|Superiority or Other|||||||0.011||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA < 169 copies/mL at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734734|NCT00507507|3193897|Superiority or Other|||||||0.034||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA < 169 copies/mL at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734735|NCT00507507|3193897|Superiority or Other|||||||0.703||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA < 169 copies/mL at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734736|NCT00507507|3193898|Superiority or Other|||||||0.03||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 144: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA < 400 copies/mL at Week 144 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734737|NCT00507507|3193898|Superiority or Other|||||||0.009||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 96: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA < 400 copies/mL at Week 96 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734738|NCT00507507|3193898|Superiority or Other|||||||0.05||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||Analysis at Week 48: the null hypothesis was that there was no difference in the proportion of subjects with HBV DNA < 400 copies/mL at Week 48 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference.|
1734739|NCT00507507|3193899|Superiority or Other|||||||0.016||||||A Fisher exact test with a 0.05 two-sided significance level was used.|Fisher Exact|||The null hypothesis was that there was no difference in the proportion of subjects with HBV DNA < 400 copies/mL at Week 192 between the Tenofovir DF and FTC+Tenofovir DF groups; the alternative hypothesis was that there was a difference. The sample size provided at least 85% power to detect a difference of 30% between the groups, assuming response rates of 30% and 60% in the Tenofovir DF and FTC+Tenofovir DF groups, respectively.|
1734740|NCT00507455|3193915|Non-Inferiority or Equivalence|If the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec for Qmax, then the treatment is non-inferior to the placebo in Qmax.|LS Mean Difference|2.18|||||2-Sided|95.0|0.98|3.37|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.|
1734741|NCT00507455|3193915|Non-Inferiority or Equivalence|If the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec for Qmax, then the treatment is non-inferior to the placebo in Qmax.|LS Mean Difference|1.67|||||2-Sided|95.0|0.5|2.85|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.|
1734742|NCT00507455|3193917|Non-Inferiority or Equivalence|If the upper limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O for PdetQmax, then the treatment is non-inferior to the placebo in PdetQmax.|LS Mean Difference|-5.0|||||2-Sided|95.0|-13.85|3.84|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.|
1734743|NCT00507455|3193917|Non-Inferiority or Equivalence|If the upper limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O for PdetQmax, then the treatment is non-inferior to the placebo in PdetQmax.|LS Mean Difference|-6.15|||||2-Sided|95.0|-14.67|2.37|||||Least squares (LS) means were analyzed using analysis of covariance (ANCOVA) with the site and treatment group as the factors and the baseline value as the covariate.|A hierarchical step-down procedure was used to control for multiplicity. The comparison between solifenacin 6 mg + tamsulosin 0.4 mg and placebo was conducted first. If non-inferiority was demonstrated, solifenacin 9 mg + tamsulosin 0.4 mg was then compared to placebo. If the first comparison did not demonstrate non-inferiority, no further testing was performed. This procedure maintained the overall type I error of 1-sided 2.5%.|
1734744|NCT00507429|3193931|Superiority or Other|||||||0.223|||||||Log Rank||||
1734745|NCT00507416|3193939|Superiority or Other|||||||0.458||||||The global difference among arms was based on the Wald test.|Wald test||||
1734746|NCT00506831|3193976|Superiority or Other|||||||0.005|||||||t-test, 2 sided|||Null hypothesis is that the mRSS is not significantly different at month 6 compared with baseline. Paired t-test was used to compare the mean mRSS at month 6 compared with baseline.|
1734750|NCT00506493|3194004|Superiority or Other||binomial proportions|6.7|||<|0.0001|1-Sided|97.5||14.9|||Fisher Exact||||
1734751|NCT00506493|3194005|Superiority or Other||Binomial Proportions|42.6|Standard Error of the Mean|6.3|<|0.01|1-Sided|97.5|30.0|||The percent of patients off Class I and III AADs and successfully converted out of AF following treatment (ptest) will exceed the percent of patients off Class I and III AADs and convereted out of AF, as reported in literature (pcontrol=22.1%)|Fisher Exact|||"The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest > 22.1%"|
1734752|NCT00506285|3194053|Non-Inferiority or Equivalence|mixed models analysis||||||0.001||||||F(1,47)=24.8, p=.001|Mixed Models Analysis||||
1734753|NCT00506285|3194054|Non-Inferiority or Equivalence|F(1,47)=26.7, p=.001||||||0.001|||||||Mixed Models Analysis|F(1,47)=26.7, p=.001|||
1734754|NCT00506077|3194062|Superiority or Other|||||||0.736||||||The Benjamini & Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Logitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.|||
1734755|NCT00506077|3194063|Superiority or Other|||||||0.736||||||The Benjamini & Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Longitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.|||
1734756|NCT00506077|3194064|Superiority or Other|||||||0.736||||||P-Value Comments (limit 250 characters): The Benjamini & Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained Longitudinal Data Analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.|||
1734757|NCT00506077|3194065|Superiority or Other|||||||0.939||||||The Benjamini & Hochberg False Discovery Rate (FDR) approach at critical value 0.05 was used among 1 primary and 3 secondary cognition efficacy endpoints to control the false positive rate.|constrained longitudinal data analysis|The model factors were treatment, sequence, period, week (as categorical variable), site, treatment-by-week, sequence-by-week, and period-by-week.|||
1734758|NCT00505778|3194074|Non-Inferiority or Equivalence|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is <10%, then non-inferiority of Asacol QD is claimed.|Difference BID-QD Remission Rates|3.6||||0.1557|2-Sided|95.0|-1.3|8.5|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.|
1734759|NCT00505778|3194075|Superiority or Other||Difference BID-QD in Least Square Mean|-0.45||||0.1753|2-Sided|95.0|-1.09|0.2|||ANOVA|ANOVA with prior Asacol dose category as factor.|||
1734760|NCT00505778|3194076|Superiority or Other||Hazard Ratio (HR)|1.17||||0.4726|2-Sided|95.0|0.762|1.796|||Log Rank|Stratified by prior Asacol dose Category|||
1734761|NCT00505778|3194077|Non-Inferiority or Equivalence|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is <10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|0.0||||0.977|2-Sided|95.0|-4.6|4.7|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.|
1734762|NCT00505778|3194078|Non-Inferiority or Equivalence|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is <10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|0.8||||0.5426|2-Sided|95.0|-1.8|3.5|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.|
1734763|NCT00505778|3194079|Non-Inferiority or Equivalence|To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is <10%, then non-inferiority of Asacol QD is claimed.|BID-QD Difference in Remission Rates|1.3||||0.5016|2-Sided|95.0|-2.3|4.9|||Cochran-Mantel-Haenszel|Stratified by prior Asacol dose Category||Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.|
1734764|NCT00505765|3194084|Superiority or Other||Mean Difference (Final Values)|1.2|Standard Deviation|1.5||0.44|2-Sided||||||ANCOVA||||
1734765|NCT00505765|3194084|Superiority or Other||Mean Difference (Final Values)|1.9|Standard Deviation|1.5||0.21|2-Sided||||||ANCOVA||||
1734766|NCT00505375|3194103|Superiority or Other (legacy)|||||||0.0014|||||||ANCOVA|||The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the “AUC mean” and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.|
1734767|NCT00505362|3194104|Superiority or Other|||||||0.61|||||||t-test, 2 sided||||
1734768|NCT00505362|3194105|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1741658|NCT00432809|3203960|Superiority or Other|||||||0.02|||||||ANOVA||||
1734769|NCT00505076|3194118|Superiority or Other|||||||0.84|||||||ANCOVA|||The sample size was determined using the analysis of covariance power formula, n=2[za+zβ]2s2 (1−R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.|
1734770|NCT00505076|3194119|Superiority or Other|||||||0.47|||||||ANCOVA|||The sample size was determined using the analysis of covariance power formula, n=2[za+zβ]2s2 (1−R2)/d2, with za=2.24, zβ=0.842 (corresponding to power=0.80), R=the correlation between baseline and end of study measures of the outcome, d the difference between groups, and s the standard deviation of the outcome. Actual recruitment was only about 20 participants per group, but the observed R≅0.9, suggesting power to detect an effect size of 0.49.|
1734771|NCT00505076|3194120|Superiority or Other|||||||0.21|||||||ANCOVA|||An analysis of covariance (ANCOVA), adjusting for baseline scores, was used to compare treatment groups on cognitive and functional measures. The predefined primary cognition outcome measure was the MCCB (MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia Research) Consensus Cognitive Battery) composite T-score, tested at overall two-sided alpha=0.05.|
1734772|NCT00504881|3194144|Superiority or Other||Percent Reduction over Placebo|7.3|||=|0|2-Sided|95.0|-2.2|15.9|||ANCOVA|||ANCOVA on log-transformed partial seizure frequency per week over the treatment period, with log-transformed baseline seizure frequency per week as covariate, and including terms for treatment and stratification factors.|
1734773|NCT00504777|3194148|Superiority or Other|||||||0.0054|||||||t-test, 2 sided||||
1734774|NCT00504777|3194151|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1734775|NCT00504725|3194153|Superiority or Other|||||||0.15||||||Pain Level Score at Discharge|Fisher Exact||||
1734776|NCT00504725|3194153|Superiority or Other|||||||0.37||||||24 Hour Pain Level Score|Fisher Exact||||
1734777|NCT00504725|3194153|Superiority or Other|||||||0.2||||||4 Hour Pain Level Score|Fisher Exact||||
1734778|NCT00504725|3194153|Superiority or Other|||||||0.44||||||Baseline Pain Level Score|Fisher Exact||||
1734779|NCT00504725|3194154|Superiority or Other|||||||0.37|||||||ANOVA||||
1734780|NCT00504725|3194155|Superiority or Other|||||||0.14|||||||ANOVA|||IL-10|
1734781|NCT00504725|3194155|Superiority or Other|||||||0.18|||||||ANOVA|||IL-8|
1734782|NCT00504725|3194155|Superiority or Other|||||||0.39||||||We will use two way ANOVA (looking for effects due to drug and time) with a p value of 0.05 indicative of statistical significance.|ANOVA|||IL-6|
1734783|NCT00504556|3194171|Superiority or Other|||||||0.023|||||||Fisher Exact|||Major bleeds|
1734784|NCT00504556|3194171|Superiority or Other|||||||1|||||||Fisher Exact|||Major bleeds|
1734785|NCT00504556|3194171|Superiority or Other|||||||0.119|||||||Fisher Exact|||Major bleeds|
1734786|NCT00504556|3194171|Superiority or Other|||||||1|||||||Fisher Exact|||Major bleeds|
1734787|NCT00504556|3194171|Superiority or Other|||||||0.002|||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding|
1734788|NCT00504556|3194171|Superiority or Other|||||||0.807|||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding|
1734789|NCT00504556|3194171|Superiority or Other|||||||0.029|||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding|
1734790|NCT00504556|3194171|Superiority or Other|||||||1|||||||Fisher Exact|||Major or Clinically Relevant (CR) non-major bleeding|
1734791|NCT00504556|3194171|Superiority or Other|||||||0.002|||||||Fisher Exact|||All bleeds|
1734792|NCT00504556|3194171|Superiority or Other|||||||0.864|||||||Fisher Exact|||All bleeds|
1734793|NCT00504556|3194171|Superiority or Other|||||||0.104|||||||Fisher Exact|||All bleeds|
1734794|NCT00504556|3194171|Superiority or Other|||||||0.367|||||||Fisher Exact|||All bleeds|
1734795|NCT00504309|3194188|Superiority or Other||||||>|0.05|||||||Mixed Models Analysis|||Cholesterol values were compared as the average of two fasting values at the end of each treatment. Cholesterol values included LDL-C, HDL-C, total cholesterol, and calculated ratios.|
1734796|NCT00504309|3194188|Superiority or Other||||||>|0.002|||||||Mixed Models Analysis|Tukey p-values were used for post hoc comparisons.||Fasting triglycerides (mg/dL) were measured on two consecutive days and averaged for analysis at the end of each treatment period. The null hypothesis was that triglycerides did not differ between groups.|
1734797|NCT00503698|3194241|Superiority or Other||Rate ratio|1.13||||0.4409|2-Sided|95.0|0.83|1.53|||Negative binomial regression||||
1734798|NCT00503698|3194242|Superiority or Other||Cox Proportional Hazard|0.88||||0.4977|2-Sided|95.0|0.6|1.28|||Regression, Cox|Time to all-cause death analysed using stratified Cox regression model with treatment and sex as fixed factors, age and time in dialysis as covariates|||
1734799|NCT00503698|3194243|Superiority or Other||Cox Proportional Hazard|0.97||||0.91|2-Sided|95.0|0.6|1.57|||Regression, Cox|Time to all-cause death analysed using stratified Cox regression model with treatment and sex as fixed factors, age and time in dialysis as covariates|||
1734800|NCT00503425|3194260|Superiority or Other|||||||0.0001||||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 4.|t-test, 2 sided||||
1734801|NCT00503425|3194260|Superiority or Other||||||<|0.0001||||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 3.|t-test, 2 sided||||
1734802|NCT00503425|3194260|Superiority or Other||||||<|0.0001||||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 2.|t-test, 2 sided||||
1734803|NCT00503425|3194260|Superiority or Other||||||<|0.0001||||||Change from baseline in mean DAS28 was analyzed using paired t-test for course 1.|t-test, 2 sided||||
1734804|NCT00503139|3194273|Superiority or Other||||||<|0.001|||||||t-test, 1 sample|A two-sided t-test was performed to test the hypothesis.||The null hypothesis was that VAS Fatigue scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.|
1734805|NCT00503139|3194274|Superiority or Other||||||<|0.001|||||||t-test, 1 sample|A two-sided t-test was performed to test the hypothesis.||The null hypothesis was that mHAQ scores at 6 months, 1 year, 1.5 years, and 2 years were equal to the baseline score.|
1734806|NCT00502944|3194314|Superiority or Other||Rate Difference (%)|-4.0||||0.02|2-Sided|95.0|-8.0|-1.0|||Chi-squared|||HIV test accepted among patients offered|
1734807|NCT00502944|3194315|Superiority or Other||Rate Difference (%)|44.0|||<|0.001|2-Sided|95.0|42.0|47.0|||Chi-squared|||HIV test offered|
1734808|NCT00502944|3194316|Superiority or Other||Rate Difference (%)|30.0|||<|0.001|2-Sided|95.0|27.0|32.0|||Chi-squared|||HIV test completed among patients randomized|
1734809|NCT00502853|3194318|Superiority or Other|||||||0.3617|||||||Student's t-test|||Change from Baseline at Week 24|
1734810|NCT00502853|3194319|Superiority or Other|||||||0.8597|||||||Student's t-test|||Change from Baseline at Week 24|
1734811|NCT00502853|3194320|Superiority or Other|||||||0.3132|||||||Student's t-test|||Change from Baseline at Week 24|
1734812|NCT00502853|3194321|Superiority or Other|||||||0.7002|||||||Student's t-test|||Change from Baseline at Week 24|
1734813|NCT00502853|3194322|Superiority or Other|||||||1|||||||Student's t-test|||Change from Baseline at Week 24|
1734814|NCT00502853|3194323|Superiority or Other|||||||0.5002|||||||Student's t-test|||Change from Baseline at Week 24|
1734815|NCT00502853|3194324|Superiority or Other||Slope|0.3688|Standard Error of the Mean|0.5987||0.5531|||||||Random coefficient model|||Trend over time|
1734816|NCT00502853|3194324|Superiority or Other|||||||0.6773|||||||Student's t-test|||Change from Baseline at Week 24|
1734817|NCT00502853|3194324|Superiority or Other|||||||0.2198|||||||Student's t-test|||Change from Baseline at Week 12|
1734818|NCT00502853|3194324|Superiority or Other|||||||0.4963|||||||Student's t-test|||Change from Baseline at Week 4|
1734819|NCT00502853|3194325|Superiority or Other||Slope|0.3997|Standard Error of the Mean|0.2506||0.1451|||||||Random coefficient model|||Trend over time|
1734820|NCT00502853|3194325|Superiority or Other|||||||0.2101|||||||Student's t-test|||Change from Baseline at Week 24|
1734821|NCT00502853|3194325|Superiority or Other|||||||0.4047|||||||Student's t-test|||Change from Baseline at Week 12|
1734822|NCT00502853|3194325|Superiority or Other|||||||0.0934|||||||Student's t-test|||Change from Baseline at Week 4|
1734823|NCT00502853|3194326|Superiority or Other|||||||0.567|||||||Student's t-test|||Change from Baseline at Week 24|
1734824|NCT00502853|3194326|Superiority or Other|||||||0.2216|||||||Student's t-test|||Change from Baseline at Week 12|
1734825|NCT00502853|3194326|Superiority or Other|||||||0.2938|||||||Student's t-test|||Change from Baseline at Week 4|
1734826|NCT00502853|3194327|Superiority or Other||Slope|-55.4458|Standard Error of the Mean|33.5821||0.1331|||||||Random coefficient model|||Trend over time|
1734827|NCT00502853|3194327|Superiority or Other|||||||0.1685|||||||Student's t-test|||Change from Baseline at Week 24|
1734828|NCT00502853|3194327|Superiority or Other|||||||0.0832|||||||Student's t-test|||Change from Baseline at Week 12|
1734829|NCT00502853|3194327|Superiority or Other|||||||0.1725|||||||Student's t-test|||Change from Baseline at Week 4|
1734830|NCT00502853|3194328|Superiority or Other||Slope|8.8196|Standard Error of the Mean|16.4534||0.6049|||||||Random coefficient model|||Trend over time|
1734831|NCT00502853|3194328|Superiority or Other|||||||0.4133|||||||Student's t-test|||Change from Baseline at Week 24|
1734832|NCT00502853|3194328|Superiority or Other|||||||0.0662|||||||Student's t-test|||Change from Baseline at Week 12|
1734833|NCT00502853|3194328|Superiority or Other|||||||0.1312|||||||Student's t-test|||Change from Baseline at Week 4|
1734834|NCT00502853|3194329|Superiority or Other||Slope|-0.2927|Standard Error of the Mean|1.9408||0.8835|||||||Random coefficient model|||Trend over time|
1734835|NCT00502853|3194329|Superiority or Other|||||||0.8816|||||||Student's t-test|||Change from Baseline at Week 24|
1734836|NCT00502853|3194329|Superiority or Other|||||||0.1631|||||||Student's t-test|||Change from Baseline at Week 12|
1734837|NCT00502853|3194329|Superiority or Other|||||||0.7376|||||||Student's t-test|||Change from Baseline at Week 4|
1734838|NCT00502853|3194330|Superiority or Other||Slope|-4.7586|Standard Error of the Mean|1.5278||0.0124|||||||Random coefficient model|||Trend over time|
1734839|NCT00502853|3194330|Superiority or Other|||||||0.0271|||||||Student's t-test|||Change from Baseline at Week 24|
1734840|NCT00502853|3194330|Superiority or Other|||||||0.0384|||||||Student's t-test|||Change from Baseline at Week 12|
1734841|NCT00502853|3194330|Superiority or Other|||||||0.0254|||||||Student's t-test|||Change from Baseline at Week 4|
1734842|NCT00502853|3194331|Superiority or Other||Slope|-0.2902|Standard Error of the Mean|0.07966||0.0054|||||||Random coefficient model|||Trend over time|
1734843|NCT00502853|3194331|Superiority or Other|||||||0.005|||||||Student's t-test|||Change from Baseline at Week 24|
1734844|NCT00502853|3194331|Superiority or Other|||||||0.005|||||||Student's t-test|||Change from Baseline at Week 12|
1734845|NCT00502853|3194331|Superiority or Other|||||||0.1396|||||||Student's t-test|||Change from Baseline at Week 4|
1734846|NCT00502853|3194332|Superiority or Other|||||||0.1542|||||||Student's t-test|||Change from Baseline at Week 24|
1734847|NCT00502853|3194332|Superiority or Other|||||||0.0132|||||||Student's t-test|||Change from Baseline at Week 12|
1734848|NCT00502853|3194332|Superiority or Other|||||||0.1273|||||||Student's t-test|||Change from Baseline at Week 4|
1734849|NCT00502853|3194332|Superiority or Other||Slope|-6.6294|Standard Error of the Mean|1.8623||0.0074|||||||Random Coefficient Model|||Trend over time|
1734850|NCT00502853|3194333|Superiority or Other||Slope|-0.1964|Standard Error of the Mean|0.04524||0.0019|||||||Random Coefficient Model|||Trend over time|
1734851|NCT00502853|3194333|Superiority or Other|||||||0.0018|||||||Student's t-test|||Change from Baseline at Week 24|
1734852|NCT00502853|3194333|Superiority or Other|||||||0.0045|||||||Student's t-test|||Change from Baseline at Week 12|
1734853|NCT00502853|3194333|Superiority or Other|||||||0.024|||||||Student's t-test|||Change from Baseline at Week 4|
1734854|NCT00502853|3194334|Superiority or Other||Slope|-4.2681|Standard Error of the Mean|2.0529||0.0712|||||||Random coefficient model|||Trend over time|
1734855|NCT00502853|3194334|Superiority or Other|||||||0.0212|||||||Student's t-test|||Change from Baseline at Week 24|
1734856|NCT00502853|3194334|Superiority or Other|||||||0.7624|||||||Student's t-test|||Change from Baseline at Week 4|
1734857|NCT00502853|3194335|Superiority or Other||Slope|0.003418|Standard Error of the Mean|0.02345||0.8877|||||||Random coefficient model|||Trend over time|
1741659|NCT00432809|3203960|Superiority or Other||||||<|0.001|||||||ANOVA||||
1734860|NCT00502853|3194336|Superiority or Other||Slope|-2.0857|Standard Error of the Mean|0.4965||0.0023|||||||Random coefficient model|||Trend over time|
1734861|NCT00502853|3194336|Superiority or Other|||||||0.0018|||||||Student's t-test|||Change from Baseline at Week 24|
1734862|NCT00502853|3194336|Superiority or Other|||||||0.0003|||||||Student's t-test|||Change from Baseline at Week 12|
1734863|NCT00502853|3194336|Superiority or Other|||||||0.1101|||||||Student's t-test|||Change from Baseline at Week 4|
1734864|NCT00502853|3194337|Superiority or Other||Slope|0.1786|Standard Error of the Mean|0.1123||0.1463|||||||Random coefficient model|||Trend over time|
1734865|NCT00502853|3194337|Superiority or Other|||||||0.1475|||||||Student's t-test|||Change from Baseline to Week 24|
1734866|NCT00502853|3194337|Superiority or Other|||||||0.5911|||||||Student's t-test|||Change from Baseline to Week 4|
1734867|NCT00502853|3194338|Superiority or Other||Slope|0.1357|Standard Error of the Mean|0.9051||0.8841|||||||Random coefficient model|||Trend over time|
1734868|NCT00502853|3194338|Superiority or Other|||||||0.8834|||||||Student's t-test|||Change from Baseline to Week 24|
1734869|NCT00502853|3194338|Superiority or Other|||||||0.8989|||||||Student's t-test|||Change from Baseline to Week 4|
1734870|NCT00502853|3194339|Superiority or Other||Slope|-0.1606|Standard Error of the Mean|0.1231||0.2246|||||||Random coefficient model|||Trend over time|
1734871|NCT00502853|3194339|Superiority or Other|||||||0.1215|||||||Student's t-test|||Change from Baseline to Week 24|
1734872|NCT00502853|3194339|Superiority or Other|||||||0.1776|||||||Student's t-test|||Change from Baseline to Week 4|
1734873|NCT00502775|3194378|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|0.16||0.374||95.0|-0.2|0.5|||ANCOVA||Mean Difference = Mean Change in Fexofenadine - Mean Change in Placebo||
1734874|NCT00502775|3194378|Superiority or Other||Mean Difference (Net)|-0.8|Standard Error of the Mean|0.16|<|0.001||95.0|-1.1|-0.4|||ANCOVA||Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Placebo||
1734875|NCT00502775|3194378|Superiority or Other||Mean Difference (Net)|-0.9|Standard Error of the Mean|0.16|<|0.001||95.0|-1.2|-0.6||Symptom scores were grouped in 3 families: nasal, ocular, instantaneous. Within each family, results of hypothesis tests were adjusted using Hochberg’s method.|ANCOVA|No other strata or covariates, other than investigator, were defined.|Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Fexofenadine|The primary efficacy measure, mean change from baseline over the two-week treatment period in NSS compared between fluticasone furoate and fexofenadine, was assessed at a significance level of α=0.05. If the null hypothesis of this comparison was rejected, then the secondary measures were subject to hypothesis testing. The study was powered at 90%.|
1734876|NCT00502697|3194380|Superiority or Other|||||||0.64|||||||Wilcoxon (Mann-Whitney)|||The original proposed sample size for this study was 300. This sample size was based on previous evidence that indicated that a reduction of 15% in the rate of preterm birth would be detectable with groups of 150. Because of concerns with systemic changes in the study's health care delivery environment, an interim analysis was conducted after 200 women had delivered. As a result of that analysis a decision was made to stop recruitment.|
1734877|NCT00502242|3194460|Superiority or Other|||||||0.486||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy|
1734878|NCT00502242|3194460|Superiority or Other|||||||0.604||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy|
1734879|NCT00502242|3194460|Superiority or Other|||||||0.179||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL|
1734880|NCT00502242|3194460|Superiority or Other|||||||0.224||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline|
1734881|NCT00502242|3194461|Superiority or Other|||||||0.753||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact||||
1734882|NCT00502242|3194462|Superiority or Other|||||||1||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact||||
1734883|NCT00502242|3194463|Superiority or Other|||||||0.726||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact||||
1734884|NCT00502242|3194464|Superiority or Other|||||||0.297||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy|
1734885|NCT00502242|3194464|Superiority or Other|||||||0.423||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy|
1734886|NCT00502242|3194464|Superiority or Other|||||||0.41||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL|
1734887|NCT00502242|3194464|Superiority or Other|||||||0.124||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline|
1734888|NCT00502242|3194465|Superiority or Other|||||||0.4773||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Week 52|
1734889|NCT00502242|3194466|Superiority or Other|||||||0.4795||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel row mean test||Post-SRL (On-Therapy), AM BCAR|
1734890|NCT00502242|3194466|Superiority or Other|||||||0.7165||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel row mean test||Post-SRL, AM BCAR|
1734891|NCT00502242|3194468|Superiority or Other||Hazard Ratio (HR)|2.487||||0.0732|2-Sided|95.0|0.887|6.978||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Log Rank||Hazard ratio was based on the Cox proportional hazards model.||
1734892|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|-0.14|Standard Error of the Mean|0.17||0.408|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 52|
1734893|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|-0.19|Standard Error of the Mean|0.17||0.264|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 24|
1734894|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|-0.2|Standard Error of the Mean|0.15||0.18|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 12|
1734895|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|-0.25|Standard Error of the Mean|0.12||0.044|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||Triglycerides, Week 4|
1734896|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|0.26|Standard Error of the Mean|0.13||0.041|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 52|
1734897|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|0.1|Standard Error of the Mean|0.13||0.457|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 24|
1734898|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|0.14|Standard Error of the Mean|0.11||0.217|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 12|
1734899|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|0.03|Standard Error of the Mean|0.09||0.766|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||LDL-C, Week 4|
1734900|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|0.05|Standard Error of the Mean|0.05||0.229|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 52|
1734901|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|0.02|Standard Error of the Mean|0.04||0.637|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 24|
1734902|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|0.0|Standard Error of the Mean|0.03||0.919|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 12|
1734903|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|-0.03|Standard Error of the Mean|0.03||0.451|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||HDL-C, Week 4|
1734904|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|0.1|Standard Error of the Mean|0.15||0.503|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 52|
1734905|NCT00502242|3194469|Superiority or Other||Difference in adjusted means|0.02|Standard Error of the Mean|0.14||0.903|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 24|
1734906|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|0.01|Standard Error of the Mean|0.13||0.956|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 12|
1734907|NCT00502242|3194469|Superiority or Other||Difference in Adjusted Means|-0.09|Standard Error of the Mean|0.1||0.381|2-Sided|||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA with treatment as a factor and baseline as a covariate||TC, Week 4|
1734908|NCT00502242|3194470|Superiority or Other|||||||0.261||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy|
1734909|NCT00502242|3194470|Superiority or Other|||||||0.752||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy|
1734910|NCT00502242|3194470|Superiority or Other|||||||0.069||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL|
1734911|NCT00502242|3194470|Superiority or Other|||||||0.064||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline|
1734912|NCT00502242|3194471|Superiority or Other|||||||0.356||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off-Therapy|
1734913|NCT00502242|3194471|Superiority or Other|||||||0.297||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On-Therapy|
1734914|NCT00502242|3194471|Superiority or Other|||||||0.626||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL|
1734915|NCT00502242|3194471|Superiority or Other|||||||1||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline|
1734916|NCT00502242|3194473|Superiority or Other|||||||0.475||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline, Low SBP: ≤90 mmHg|
1734917|NCT00502242|3194473|Superiority or Other|||||||0.475||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Baseline, Low DBP ≤50 mmHg|
1734918|NCT00502242|3194473|Superiority or Other|||||||1||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off Therapy, Low SBP: ≤90 mmHg|
1734919|NCT00502242|3194473|Superiority or Other|||||||1||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Off Therapy, High DBP ≥110 mmHg|
1734920|NCT00502242|3194473|Superiority or Other|||||||0.106||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, High SBP: ≥180 mmHg|
1734921|NCT00502242|3194473|Superiority or Other|||||||1||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, Low SBP: ≤90 mmHg|
1734922|NCT00502242|3194473|Superiority or Other|||||||0.227||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, High DBP ≥110 mmHg|
1734923|NCT00502242|3194473|Superiority or Other|||||||0.725||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||On Therapy, Low DBP ≤50 mmHg|
1734924|NCT00502242|3194473|Superiority or Other|||||||1||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, High SBP: ≥180 mmHg|
1734925|NCT00502242|3194473|Superiority or Other|||||||0.47||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, Low SBP: ≤90 mmHg|
1734926|NCT00502242|3194473|Superiority or Other|||||||0.22||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, High DBP ≥110 mmHg|
1734927|NCT00502242|3194473|Superiority or Other|||||||0.47||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Pre-SRL, Low DBP ≤50 mmHg|
1734928|NCT00502242|3194474|Superiority or Other||Treatment Ratio|1.04||||0.7519|2-Sided|95.0|0.82|1.31||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|Log (Fraction of albumin to protein in urine) as dependent variable, treatment and region/race as factor, and Log(baseline) as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean.|Week 52|
1734929|NCT00502242|3194474|Superiority or Other||Treatment Ratio|0.84||||0.1167|2-Sided|95.0|0.68|1.04||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|Log (Fraction of albumin to protein in urine) as dependent variable, treatment and region/race as factor, and Log(baseline) as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean.|Week 24|
1734930|NCT00502242|3194475|Superiority or Other||Adjusted LS Mean Difference|2.12|Standard Error of the Mean|1.46||0.1475|2-Sided|95.0|-0.75|4.99||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate|Adjusted for baseline|Change from Baseline at Week 52|
1734931|NCT00502242|3194475|Superiority or Other||Adjusted LS Mean Difference|2.48|Standard Error of the Mean|1.45||0.0888|2-Sided|95.0|-0.38|5.33||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate.|Adjusted for baseline|Change from Baseline at Week 24|
1734932|NCT00502242|3194475|Superiority or Other||Adjusted LS Mean Difference|-0.86|Standard Error of the Mean|1.26||0.4933|2-Sided|95.0|-3.33|1.61||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with MDRD change as dependent variable, treatment and region/race as factors, and baseline as covariate.|Adjusted for baseline|Change from Baseline at Week 12|
1734933|NCT00502242|3194476|Superiority or Other|||||||0.1115||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion|
1734934|NCT00502242|3194476|Superiority or Other|||||||1||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion|
1734935|NCT00502242|3194477|Superiority or Other||Treatment Ratio|0.85||||0.3496|2-Sided|95.0|0.6|1.2||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 52, Ramipril vs. Placebo|
1734936|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|3.45|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 52, Placebo|
1734937|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|2.92|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 52, Ramipril|
1734938|NCT00502242|3194477|Superiority or Other||Treatment Ratio|0.77||||0.1146|2-Sided|95.0|0.56|1.07||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 36, Ramipril vs. Placebo|
1734939|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|3.27|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 36, Placebo|
1734940|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|2.52|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 36, Ramipril|
1734941|NCT00502242|3194477|Superiority or Other||Treatment Ratio|0.74||||0.0577|2-Sided|95.0|0.54|1.01||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 30, Ramipril vs. Placebo|
1734942|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|3.39|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 30, Placebo|
1734943|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|2.5|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 30, Ramipril|
1734944|NCT00502242|3194477|Superiority or Other||Treatment Ratio|0.69||||0.013|2-Sided|95.0|0.51|0.92||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 24, Ramipril vs. Placebo|
1734945|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|3.39|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 24, Placebo|
1734946|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|2.33|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 24, Ramipril|
1734947|NCT00502242|3194477|Superiority or Other||Treatment Ratio|0.65||||0.0032|2-Sided|95.0|0.49|0.87||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 12, Ramipril vs. Placebo|
1734948|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|2.92|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 12, Placebo|
1734949|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|1.91|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 12, Ramipril|
1734950|NCT00502242|3194477|Superiority or Other||Treatment Ratio|0.61||||0.0002|2-Sided|95.0|0.47|0.79||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 8, Ramipril vs. Placebo|
1734951|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|2.74|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 8, Placebo|
1734952|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|1.67|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 8, Ramipril|
1734953|NCT00502242|3194477|Superiority or Other||Treatment Ratio|0.6|||<|0.0001|2-Sided|95.0|0.47|0.76||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 4, Ramipril vs. Placebo|
1734954|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|2.37|||<||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 4, Placebo|
1734955|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|1.43|||<||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 4, Ramipril|
1734956|NCT00502242|3194477|Superiority or Other||Treatment Ratio|0.71|||<|0.0034|2-Sided|95.0|0.57|0.89||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic U alb/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 3, Ramipril vs. Placebo|
1734957|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|2.05|||<||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 3, Placebo|
1734958|NCT00502242|3194477|Superiority or Other||Adjusted Geometric Mean Fold Change|1.46|||<||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 3, Ramipril|
1734959|NCT00502242|3194478|Superiority or Other||Treatment Ratio|0.84||||0.06|2-Sided|95.0|0.7|1.01||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 52, Ramipril vs. Placebo|
1734960|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.86|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 52, Placebo|
1734961|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.56|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 52, Ramipril|
1734962|NCT00502242|3194478|Superiority or Other||Treatment Ratio|0.84||||0.0341|2-Sided|95.0|0.72|0.99||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 36, Ramipril vs. Placebo|
1734963|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.67|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 36, Placebo|
1734964|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.4|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 36, Ramipril|
1734965|NCT00502242|3194478|Superiority or Other||Treatment Ratio|0.79||||0.0062|2-Sided|95.0|0.66|0.93||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 30, Ramipril vs. Placebo|
1734966|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.82|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 30, Placebo|
1734967|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.43|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 30, Ramipril|
1734968|NCT00502242|3194478|Superiority or Other||Treatment Ratio|0.83||||0.0264|2-Sided|95.0|0.7|0.98||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 24, Ramipril vs. Placebo|
1734969|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.78|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 24, Placebo|
1734970|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.48|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 24, Ramipril|
1734971|NCT00502242|3194478|Superiority or Other||Treatment Ratio|0.82||||0.0165|2-Sided|95.0|0.7|0.96||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 12, Ramipril vs. Placebo|
1734972|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.63|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 12, Placebo|
1734973|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.34|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 12, Ramipril|
1734974|NCT00502242|3194478|Superiority or Other||Treatment Ratio|0.79||||0.0016|2-Sided|95.0|0.68|0.91||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from Baseline at Week 8, Ramipril vs. Placebo|
1734975|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.61|||||2-Sided||||||||Adjusted for baseline|Change from baseline at Week 8, Placebo|
1734976|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.27|||||2-Sided||||||||Adjusted for baseline|Change from baseline at Week 8, Ramipirl|
1734977|NCT00502242|3194478|Superiority or Other||Treatment Ratio|0.78||||0.0003|2-Sided|95.0|0.68|0.89||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from baseline at Week 4, Ramipril vs. Placebo|
1734978|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.52|||||2-Sided||||||||Adjusted for baseline|Change from baseline at Week 4, Placebo|
1734979|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.18|||||2-Sided||||||||Adjusted for baseline|Change from baseline at Week 4, Ramipril|
1734980|NCT00502242|3194478|Superiority or Other||Treatment Ratio|0.85||||0.0098|2-Sided|95.0|0.76|0.96||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|ANCOVA|ANCOVA model with change in the logarithmic Up/c as dependent variable, treatment and region/race as factors, and logarithmic baseline as covariate.|Treatment ratio (Ramipril/Placebo) in the geometric mean fold-change.|Change from baseline at Week 3, Ramipril versus (vs.) Placebo|
1734981|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.36|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 3, Placebo|
1741660|NCT00432809|3203960|Superiority or Other||||||<|0.001|||||||ANOVA||||
1734982|NCT00502242|3194478|Superiority or Other||Adjusted Geometric Mean Fold Change|1.16|||||2-Sided||||||||Adjusted for baseline|Change from Baseline at Week 3, Ramipril|
1734983|NCT00502242|3194479|Superiority or Other|||||||0.121||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion|
1734984|NCT00502242|3194479|Superiority or Other|||||||0.002||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion|
1734985|NCT00502242|3194480|Superiority or Other|||||||0.219||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion|
1734986|NCT00502242|3194480|Superiority or Other|||||||0.093||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion|
1734987|NCT00502242|3194481|Superiority or Other|||||||0.074||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 52 weeks post-conversion|
1734988|NCT00502242|3194481|Superiority or Other|||||||0.002||||||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Fisher Exact|||Up to 24 weeks post-conversion|
1734989|NCT00502242|3194482|Superiority or Other||Hazard Ratio (HR)|0.425||||0.0031|2-Sided|95.0|0.237|0.763||2-sided p-value; alpha=0.05 (unadjusted for multiplicity)|Log Rank|Stratified log-rank test with region and race strata|Stratified Cox proportional hazard model with region and race strata||
1734990|NCT00502242|3194483|Superiority or Other||Hazard Ratio (HR)|0.228||||0.0002|2-Sided|95.0|0.099|0.528||2-sided p-value; alpha equals (=) 0.05|Log Rank|Stratified log-rank test with region and race strata|Stratified Cox proportional hazard model with region and race strata||
1734991|NCT00501631|3194507|Superiority or Other|||||||0.336|||||||Van der Waerden test|||The null hypothesis that there is no difference between two treatment groups (i.e. Placebo and Vivitrol) was tested using a two-sided Van der Waerden test. Response profiles were tabulated as a cumulative percent of subjects at each decile of percent heavy drinking days.|
1734992|NCT00501592|3194508|Superiority or Other|||||||0.0005|||||||t-test, 2 sided||||
1734993|NCT00501592|3194508|Superiority or Other|||||||0.0001|||||||t-test, 2 sided||||
1734994|NCT00501592|3194508|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1734995|NCT00501592|3194508|Superiority or Other||||||>|0.0031|||||||t-test, 2 sided||||
1734996|NCT00501592|3194509|Superiority or Other|||||||0.28|||||||t-test, 2 sided|||The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT‐747 50 mg using t‐tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.|
1734997|NCT00501592|3194509|Superiority or Other|||||||0.04|||||||t-test, 2 sided|||The primary endpoints are calculated as the change (post minus pre treatment) during low dose and high dose insulin infusion periods. These are compared between placebo and INT‐747 25 mg using t‐tests for independent samples. These tests will be made without correction for multiple comparisons using 0.05 as the alpha criterion for significance. Results will be described with the corresponding means and standard deviations.|
1734998|NCT00501293|3194521|Superiority or Other|||||||0.017|||||||t-test, 2 sided|t-test of placebo at baseline and 6 months|||
1734999|NCT00501293|3194521|Superiority or Other|||||||0.071|||||||t-test, 2 sided|t-test of MTS at baseline and 6 months|||
1735000|NCT00501293|3194524|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test of placebo at baseline and 6 months|||
1735001|NCT00501293|3194524|Superiority or Other||||||<|0.027|||||||t-test, 2 sided|t-test of MTS at baseline and 6 months|||
1735002|NCT00501293|3194525|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test of placebo at baseline and 6 months|||
1735003|NCT00501293|3194525|Superiority or Other||||||<|0.028|||||||t-test, 2 sided|t-test of MTS at baseline and 6 months|||
1735004|NCT00501059|3194532|Other||Cox Proportional Hazard|1.1||||0.4796|2-Sided|95.0|0.84|1.45|||Log Rank|||Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735005|NCT00501059|3194532|Other||Cox Proportional Hazard|1.03||||0.9181|2-Sided|95.0|0.55|1.95|||Log Rank|||Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735006|NCT00501059|3194532|Other||Cox Proportional Hazard|0.75||||0.538||95.0|0.3|1.87|||Log Rank|||Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735007|NCT00501059|3194532|Other||Cox Proportional Hazard|1.03||||0.9161|2-Sided|95.0|0.6|1.77|||Log Rank|||Analysis of incidence of CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735008|NCT00501059|3194532|Other||Cox Proportional Hazard|1.12||||0.6291||95.0|0.71|1.75|||Log Rank|||Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735009|NCT00501059|3194532|Other||Cox Proportional Hazard|0.55||||0.0056|2-Sided|95.0|0.36|0.84|||Log Rank|||Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735010|NCT00501059|3194532|Other||Cox Proportional Hazard|0.53||||0.0014|2-Sided|95.0|0.36|0.79|||Log Rank|||Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735011|NCT00501059|3194532|Other||Cox Proportional Hazard|0.79||||0.0661|2-Sided|95.0|0.61|1.02|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735012|NCT00501059|3194532|Other||Cox Proportional Hazard|0.81||||0.0756|2-Sided|95.0|0.64|1.02|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735418|NCT00492752|3195495|Superiority or Other||Hazard Ratio (HR)|0.9032||||0.497537||95.0|0.6705|1.2165|||Log Rank||Hazard ratio is for Sorafenib vs placebo.||
1735013|NCT00501059|3194533|Other||Cox Proportional Hazard|0.9||||0.4562|2-Sided|95.0|0.67|1.2|||Log Rank|||Analysis of incidence of non-fatal MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735014|NCT00501059|3194533|Other||Cox Proportional Hazard|0.95||||0.619|2-Sided|95.0|0.79|1.15|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke or CV death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735015|NCT00501059|3194533|Other||Cox Proportional Hazard|0.96||||0.6038|2-Sided|95.0|0.81|1.13|||Log Rank|||Analysis of incidence of composite outcome of MI, stroke, CV death, UA or TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735016|NCT00501059|3194535|Other||Cox Proportional Hazard|0.93||||0.7455|2-Sided|95.0|0.61|1.42|||Log Rank|||Analysis of incidence of TIA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735017|NCT00501059|3194535|Other||Cox Proportional Hazard|1.0||||0.9979|2-Sided|95.0|0.54|1.86|||Log Rank|||Analysis of incidence of UA was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735018|NCT00501059|3194535|Other||Cox Proportional Hazard|0.97||||0.901||95.0|0.62|1.52|||Log Rank|||Analysis of incidence of cardiovascular death was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735019|NCT00501059|3194535|Other||Cox Proportional Hazard|1.12||||0.5072||95.0|0.8|1.55|||Log Rank|||Analysis of incidence of stroke was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735020|NCT00501059|3194535|Other||Cox Proportional Hazard|0.85||||0.2325|2-Sided|95.0|0.64|1.11|||Log Rank|||Analysis of incidence of MI was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735021|NCT00501059|3194536|Other||Cox Proportional Hazard|0.99||||0.9459|2-Sided|95.0|0.8|1.24|||Log Rank|||Analysis of incidence of all-cause mortality was conducted via a 2-sided log-rank test. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735022|NCT00501059|3194537|Superiority or Other|||||||0.611|||||||Log Rank|||Analysis of time to the first occurence colon cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735023|NCT00501059|3194537|Superiority or Other|||||||0.4422|||||||Log Rank|||Analysis of time to the first occurrence of all cancers excluding non-melanoma skin cancer was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735024|NCT00501059|3194537|Superiority or Other|||||||0.9544|||||||Log Rank|||Analysis of time to all-cause mortality was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735025|NCT00501059|3194538|Superiority or Other|||||||0.5125|||||||Log Rank|||Statistics for time to total stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735026|NCT00501059|3194538|Superiority or Other|||||||0.3947|||||||Log Rank|||Statistics for time to total non-fatal stroke was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735027|NCT00501059|3194538|Superiority or Other|||||||0.229|||||||Log Rank|||Statistics for time to total MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735028|NCT00501059|3194538|Superiority or Other|||||||0.4505|||||||Log Rank|||Statistics for time to non-fatal MI was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735029|NCT00501059|3194539|Superiority or Other|||||||0.6125|||||||Log Rank|||Statistics for time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant if the 2-sided P value is ≤0.05.|
1735030|NCT00501059|3194540|Superiority or Other|||||||0.597|||||||Log Rank|||Primary efficacy analysis of time to the composite endpoint was conducted via a 2-sided log-rank test stratified for treatment, country, and sex. Results would be considered statistically significant and the primary objective of the study will have been met if the 2-sided P value is ≤0.05.|
1735031|NCT00500760|3194609|Superiority or Other||Difference in rate|1.33|||||2-Sided|95.0|-13.23|14.71|||||Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.||
1735032|NCT00500760|3194609|Superiority or Other||Odds Ratio (OR)|1.087||||1|2-Sided|95.0|0.448|2.712|||Regression, Logistic||The odds ratio is defined as the odds of having a complete response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.||
1735033|NCT00500760|3194610|Superiority or Other||Difference in rate|-10.99|||||2-Sided|95.0|-24.56|4.14|||||Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.||
1735034|NCT00500760|3194610|Superiority or Other||Odds Ratio (OR)|0.535||||0.1737|2-Sided|95.0|0.217|1.262|||Regression, Logistic||The odds ratio is defined as the odds of having an overall response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.||
1735035|NCT00500760|3194611|Superiority or Other||Hazard Ratio (HR)|1.628||||0.1223|2-Sided|95.0|0.877|3.019|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.||
1735036|NCT00500760|3194612|Superiority or Other||Hazard Ratio (HR)|1.15||||0.6069|2-Sided|95.0|0.675|1.961|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.||
1735037|NCT00500760|3194613|Superiority or Other||Hazard Ratio (HR)|1.328||||0.3106|2-Sided|95.0|0.767|2.299|||Regression, Cox||Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.||
1741661|NCT00432809|3203961|Superiority or Other|||||||0.02|||||||ANOVA||||
1735038|NCT00500760|3194614|Superiority or Other||Difference in Kaplan-Meier estimate|-0.03|||||2-Sided|95.0|-1.09|0.12|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|Difference between treatment groups at 12 months|
1735039|NCT00500760|3194614|Superiority or Other||Difference in Kaplan-Meier estimate|-0.03|||||2-Sided|95.0|-0.18|0.12|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.|Difference between treatment groups at 6 months|
1735040|NCT00500760|3194615|Superiority or Other||Difference in Kaplan-Meier estimate|-0.07|||||2-Sided|95.0|-0.23|0.09|||||The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.||
1735041|NCT00500656|3194620|Superiority or Other||||||<|0.001|||||||The Wilcoxon version of the log rank|The median time to almost complete symptom relief was calculated using Kaplan Meier methodology.The Wilcoxon version of the log rank test SAS was used|||
1735042|NCT00500656|3194621|Superiority or Other||Hazard Ratio (HR)|3.475|||<|0.001|2-Sided|95.0|1.901|6.355|||The Wilcoxon version of the log rank|The median time to onset was calculated using Kaplan Meier methodology. The Wilcoxon version of the log rank test of SAS was used|||
1735043|NCT00500370|3194631|Superiority or Other|||||||0.0293|||||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)|
1735044|NCT00500370|3194632|Superiority or Other|||||||0.2919|||||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)|
1735045|NCT00500370|3194633|Superiority or Other|||||||0.2593|||||||Cochran-Mantel-Haenszel||||
1735046|NCT00500370|3194634|Superiority or Other|||||||0.6507|||||||Cochran-Mantel-Haenszel||||
1735047|NCT00500370|3194635|Superiority or Other|||||||0.8973|||||||ANCOVA||||
1735048|NCT00500370|3194636|Superiority or Other|||||||0.7619|||||||ANCOVA||||
1735049|NCT00500370|3194637|Superiority or Other|||||||0.2151|||||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)|
1735050|NCT00500370|3194638|Superiority or Other|||||||0.8479|||||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)|
1735051|NCT00500370|3194639|Superiority or Other|||||||0.1204|||||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)|
1735052|NCT00500370|3194640|Superiority or Other|||||||0.6651|||||||ANCOVA||||
1735053|NCT00500370|3194641|Superiority or Other|||||||0.1204|||||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)|
1735054|NCT00500370|3194642|Superiority or Other|||||||0.1808|||||||ANCOVA|||Analysis pertains to change at endpoint (Week 24)|
1735055|NCT00500370|3194643|Superiority or Other|||||||0.0393|||||||Cochran-Mantel-Haenszel||||
1735056|NCT00500370|3194644|Superiority or Other|||||||0.6766|||||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)|
1735057|NCT00500370|3194645|Superiority or Other||||||<|0.0001|||||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)|
1735058|NCT00500370|3194646|Superiority or Other||||||<|0.0001|||||||Mixed Model Repeated Measures ANCOVA|||Analysis pertains to change at endpoint (Week 24)|
1735059|NCT00500357|3194647|Superiority or Other||geometric mean fold rise|1.06|||||2-Sided|95.0|0.9|1.25|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735060|NCT00500357|3194647|Superiority or Other||geometric mean fold rise|0.54|||||2-Sided|95.0|0.47|0.62|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735061|NCT00500357|3194647|Superiority or Other||geometric mean fold rise|0.78|||||2-Sided|95.0|0.69|0.88|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735062|NCT00500357|3194647|Superiority or Other||geometric mean fold rise|0.67|||||2-Sided|95.0|0.6|0.74|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735063|NCT00500357|3194647|Superiority or Other||geometric mean fold rise|0.59|||||2-Sided|95.0|0.51|0.67|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735064|NCT00500357|3194647|Superiority or Other||geometric mean fold rise|0.6|||||2-Sided|95.0|0.53|0.68|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735065|NCT00500357|3194647|Superiority or Other||geometric mean fold rise|0.68|||||2-Sided|95.0|0.58|0.79|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735066|NCT00500357|3194647|Superiority or Other||geometric mean fold rise|1.07|||||2-Sided|95.0|0.94|1.21|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735067|NCT00500357|3194647|Superiority or Other||geometric mean fold rise|1.49|||||2-Sided|95.0|1.27|1.75|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735113|NCT00500331|3194670|Superiority or Other||Mean Difference (Net)|-0.9|||<|0.001|2-Sided|95.0|-1.19|-0.61||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 500 mg|
1735068|NCT00500357|3194647|Superiority or Other||geometric mean fold rise|0.68|||||2-Sided|95.0|0.61|0.76|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735069|NCT00500357|3194647|Superiority or Other||geometric mean fold rise|0.75|||||2-Sided|95.0|0.65|0.87|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735070|NCT00500357|3194647|Superiority or Other||geometric mean fold rise|0.55|||||2-Sided|95.0|0.48|0.64|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735071|NCT00500357|3194647|Superiority or Other||geometric mean fold rise|0.68|||||2-Sided|95.0|0.6|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735072|NCT00500357|3194648|Superiority or Other||geometric mean fold rise|0.76|||||2-Sided|95.0|0.62|0.93|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735073|NCT00500357|3194648|Superiority or Other||geometric mean fold rise|0.64|||||2-Sided|95.0|0.52|0.79|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735074|NCT00500357|3194648|Superiority or Other||geometric mean fold rise|0.6|||||2-Sided|95.0|0.49|0.74|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735075|NCT00500357|3194648|Superiority or Other||geometric mean fold rise|0.38|||||2-Sided|95.0|0.31|0.46|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735076|NCT00500357|3194648|Superiority or Other||geometric mean fold rise|0.76|||||2-Sided|95.0|0.59|0.98|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735077|NCT00500357|3194648|Superiority or Other||geometric mean fold rise|0.5|||||2-Sided|95.0|0.42|0.6|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735078|NCT00500357|3194648|Superiority or Other||geometric mean fold rise|0.72|||||2-Sided|95.0|0.6|0.87|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735079|NCT00500357|3194648|Superiority or Other||geometric mean fold rise|0.79|||||2-Sided|95.0|0.63|0.99|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735080|NCT00500357|3194648|Superiority or Other||geometric mean fold rise|0.9|||||2-Sided|95.0|0.74|1.1|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735081|NCT00500357|3194648|Superiority or Other||geometric mean fold rise|0.32|||||2-Sided|95.0|0.27|0.39|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735082|NCT00500357|3194648|Superiority or Other||geometric mean fold rise|0.63|||||2-Sided|95.0|0.53|0.76|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735083|NCT00500357|3194648|Superiority or Other||geometric mean fold rise|0.52|||||2-Sided|95.0|0.43|0.62|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735084|NCT00500357|3194648|Superiority or Other||geometric mean fold rise|0.65|||||2-Sided|95.0|0.52|0.82|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of concentrations (Vax 3 - Vax 1).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735085|NCT00500357|3194649|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.5|||||2-Sided|95.0|1.18|1.94|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 23F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735114|NCT00500331|3194670|Superiority or Other||Mean Difference (Net)|-0.74|||<|0.001|2-Sided|95.0|-1.03|-0.44||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 250 mg|
1735086|NCT00500357|3194649|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||2-Sided|95.0|0.47|0.73|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735087|NCT00500357|3194649|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||2-Sided|95.0|0.58|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 19A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735088|NCT00500357|3194649|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||2-Sided|95.0|0.66|1.03|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 18C: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735089|NCT00500357|3194649|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||2-Sided|95.0|0.57|0.83|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 14: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735090|NCT00500357|3194649|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||2-Sided|95.0|0.27|0.68|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 9V: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735091|NCT00500357|3194649|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.3|||||2-Sided|95.0|0.18|0.41|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 7F: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735092|NCT00500357|3194649|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.3|||||2-Sided|95.0|1.11|1.63|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6B: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735093|NCT00500357|3194649|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|2.0|||||2-Sided|95.0|1.39|2.84|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 6A: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735094|NCT00500357|3194649|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.7|||||2-Sided|95.0|0.57|0.8|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 5: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735095|NCT00500357|3194649|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.0|||||2-Sided|95.0|0.76|1.22|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 4: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735096|NCT00500357|3194649|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||2-Sided|95.0|0.66|0.95|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735097|NCT00500357|3194649|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||2-Sided|95.0|0.34|0.57|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 2).|Serotype 1: GMFR was calculated using all participants with available data from both the Vax 2 and Vax 3 blood draws.|
1735098|NCT00500357|3194652|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|1.3|||||2-Sided|95.0|0.86|1.86|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 23F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735115|NCT00500331|3194670|Superiority or Other||Mean Difference (Net)|-0.64|||<|0.001|2-Sided|95.0|-0.94|-0.35||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 100 mg|
1735099|NCT00500357|3194652|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.5|||||2-Sided|95.0|0.35|0.67|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 19F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735100|NCT00500357|3194652|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||2-Sided|95.0|0.3|0.48|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 19A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735101|NCT00500357|3194652|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.5|||||2-Sided|95.0|0.4|0.65|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 18C: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735102|NCT00500357|3194652|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||2-Sided|95.0|0.4|0.78|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 14: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735103|NCT00500357|3194652|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.3|||||2-Sided|95.0|0.16|0.4|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 9V: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735104|NCT00500357|3194652|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||2-Sided|95.0|0.25|0.65|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 7F: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735105|NCT00500357|3194652|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||2-Sided|95.0|0.56|1.01|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 6B: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735106|NCT00500357|3194652|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||2-Sided|95.0|0.45|0.91|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 6A: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735107|NCT00500357|3194652|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||2-Sided|95.0|0.32|0.53|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 5: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735108|NCT00500357|3194652|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.6|||||2-Sided|95.0|0.44|0.72|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 4: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735109|NCT00500357|3194652|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.8|||||2-Sided|95.0|0.67|1.01|||||CI for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 - Vax 1).|Serotype 3: GMFR was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735110|NCT00500357|3194652|Non-Inferiority or Equivalence|Non-inferiority declared if the lower limit of the 95 %confidence interval for the back-transformed GMFR was > 0.5 (2-fold criterion as a basis for comparison).|geometric mean fold rise|0.4|||||2-Sided|95.0|0.28|0.56|||||Confidence Intervals (CI) for the GMFR was a back transformation of a CI based on the Student t distribution for the mean difference of the logarithms of titers (Vax 3 minus [-] Vax 1).|Serotype 1: Geometric mean fold rise (GMFR) was calculated using all participants with available data from both the Vax 1 and Vax 3 blood draws.|
1735111|NCT00500331|3194670|Superiority or Other||Mean Difference (Net)|-0.76|||<|0.001|2-Sided|95.0|-1.05|-0.47||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. Pioglitazone 30 mg|
1735112|NCT00500331|3194670|Superiority or Other||Mean Difference (Net)|-1.07|||<|0.001|2-Sided|95.0|-1.36|-0.77||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 1000 mg|
1735116|NCT00500331|3194670|Superiority or Other||Mean Difference (Net)|-0.73|||<|0.001|2-Sided|95.0|-1.02|-0.44||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment||Placebo vs. GSK189075 50 mg|
1735117|NCT00500331|3194670|Other|Tukey’s trend test for dose response|||||<|0.001||||||Tukey’s trend test adjusts for multiplicity with statistical significance based on p-value <0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg|
1735118|NCT00500331|3194670|Other|Tukey’s trend test for dose response|||||<|0.001||||||Tukey’s trend test adjusts for multiplicity with statistical significance based on p-value <0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg|
1735119|NCT00500331|3194670|Other|Tukey’s trend test for dose response|||||<|0.001||||||Tukey’s trend test adjusts for multiplicity with statistical significance based on p-value <0.05|ANCOVA|Change=Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg|
1735120|NCT00500331|3194670|Other|Tukey’s trend test for dose response|||||<|0.001||||||Tukey’s trend test adjusts for multiplicity with statistical significance based on p-value <0.05|ANCOVA|||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mg|
1735121|NCT00500331|3194670|Other|Tukey’s trend test for dose response: Change= Baseline+Treatment|||||<|0.001||||||Tukey’s trend test adjusts for multiplicity with statistical significance based on p-value <0.05|ANCOVA|Change= Baseline+Treatment||Placebo, GSK189075 50 mg, GSK189075 100 mg, GSK189075 250 mg, GSK189075 500 mg, GSK189075 1000 mg|
1735122|NCT00500318|3194675|Superiority or Other||Least Square Mean|116.44|Standard Error of the Mean|40.113||0.0042|2-Sided|95.0|37.28|195.61|||ANCOVA||||
1735123|NCT00500149|3194680|Superiority or Other||||||<|0.0001|||||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 13.0 hours post-dose|
1735124|NCT00500149|3194680|Superiority or Other||||||<|0.001|||||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 12.0 hours post-dose|
1735125|NCT00500149|3194680|Superiority or Other||||||<|0.0001|||||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 10.0 hours post-dose|
1735126|NCT00500149|3194680|Superiority or Other||||||<|0.0001|||||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 7.5 hours post-dose|
1735127|NCT00500149|3194680|Superiority or Other||||||<|0.0001|||||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 5.0 hours post-dose|
1735128|NCT00500149|3194680|Superiority or Other||||||<|0.0001|||||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 2.5 hours post-dose|
1735129|NCT00500149|3194680|Superiority or Other||||||<|0.0001|||||||ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 1.5 hours post-dose|
1735130|NCT00500149|3194681|Superiority or Other||||||<|0.0001||||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 13.0 hours post-dose|
1735131|NCT00500149|3194681|Superiority or Other||||||<|0.0001||||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 12.0 hours post-dose|
1735132|NCT00500149|3194681|Superiority or Other||||||<|0.0001||||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 10.0 hours post-dose|
1735133|NCT00500149|3194681|Superiority or Other||||||<|0.0001||||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 7.5 hours post-dose|
1735134|NCT00500149|3194681|Superiority or Other||||||<|0.0001||||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 5.0 hours post-dose|
1735135|NCT00500149|3194681|Superiority or Other||||||<|0.0001||||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 2.5 hours post-dose|
1735184|NCT00497796|3194903|Superiority or Other|||||||0.3742||||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||Analysis of 6 months post-transplant|
1741662|NCT00432809|3203961|Superiority or Other||||||<|0.001|||||||ANOVA||||
1735136|NCT00500149|3194681|Superiority or Other||||||<|0.0001||||||The primary efficacy variable will be onset of effect, which will be determined from the results of inferential analyses across multiple time points. No adjustment will be made to the levels of significance as a result of the multiple comparisons.|ANCOVA|Using a linear mixed model that includes sequence, period, and treatment group as fixed effects and subject-within-sequence as a random effect.||Statistical analysis of SKAMP scores at 1.5 hours post-dose|
1735137|NCT00500071|3194683|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided|||Metacognition Index|
1735138|NCT00500071|3194683|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided|||Behavioral Recognition Index|
1735139|NCT00500071|3194683|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided|||Global Executive Composite|
1735140|NCT00500071|3194684|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided||||
1735141|NCT00500071|3194687|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided||||
1735142|NCT00500071|3194688|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided|||Week 7|
1735143|NCT00500071|3194688|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided|||Week 6|
1735144|NCT00500071|3194688|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided|||Week 5|
1735145|NCT00500071|3194688|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided|||Week 4|
1735146|NCT00500071|3194688|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided|||Week 3|
1735147|NCT00500071|3194688|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided|||Week 2|
1735148|NCT00500071|3194688|Superiority or Other||||||<|0.0001|||||||t-test, 1 sided|||Week 1|
1735149|NCT00499863|3194703|Superiority or Other|||||||0.288|||||||ANCOVA||||
1735150|NCT00499863|3194704|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1735151|NCT00499863|3194705|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1735152|NCT00499863|3194706|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1735153|NCT00499863|3194707|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis was that there is no difference between MTS and placebo.|
1735154|NCT00499616|3194735|Other||Chi-Square Test Statistic|9.9111||||0.0016|2-Sided|95.0|||||Chi-squared|||The association between extent of surgical resection with occurrence of complications was determined using the chi-square test.|
1735155|NCT00499616|3194736|Other|The overall survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.|Log Rank Test Statistic|2.6709||||0.1022|2-Sided|95.0|||||Log Rank||||
1735156|NCT00499616|3194737|Other||Log-Rank Test Statistic|5.0049||||0.0253|2-Sided|95.0|||||Log Rank|||The event-free survival distributions of patients with complete surgical resection and patients without complete surgical resection were compared using the log-rank test.|
1735157|NCT00499616|3194741|Other||Log Rank Test Statistic|0.9841||||0.3212|2-Sided|95.0|||||Log Rank|||The event-free survival distributions of patients between 12-18 months of age with Stage 4 neuroblastoma and favorable biological features on ANBL0531 and patients less than 12 months of age with Stage 4 neuroblastoma on A3961 were compared using the log-rank test.|
1735158|NCT00499460|3194758|Superiority|The secondary hypothesis being tested is that garlic powder treatment induces intestinal P-glycoprotein, reduces the bioavailability and hence AUC of orally administered digoxin.|||||>|0.05|||||||t-test, 1 sided|Garlic powder versus placebo|||
1735159|NCT00499460|3194759|Superiority||||||>|0.05|||||||t-test, 1 sided|Garlic powder versus placebo||The secondary hypothesis being tested is that garlic powder induces CYP3A-mediated metabolism resulting in a lower oral midazolam AUC.|
1735160|NCT00499460|3194760|Superiority|The secondary hypothesis being tested is that garlic powder treatment lowers opioid side effects after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is total CASE rating score. Explanatory variables include treatment, period, time and gender, along with their interaction terms.|||
1735161|NCT00499460|3194761|Superiority|The secondary hypothesis being tested is that garlic powder treatment lowers opioid side effects after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is total SSE rating score. Explanatory variables include treatment, period, time and gender, along with their interaction terms.|||
1735162|NCT00499460|3194762|Superiority|The secondary hypothesis being tested is that powder garlic treatment lowers Cold Pressor Test tolerance (i.e., diminished analgesic response) after oxycodone administration due to a more rapid metabolic clearance and lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is log Tolerance AUC. Explanatory variables include treatment, period and gender, along with their interaction terms.|||
1735163|NCT00499460|3194763|Superiority|The primary hypothesis being tested is that garlic powder treatment increases metabolic clearance of oxycodone through enzyme induction and results in lower exposure to oxycodone.|||||>|0.05||||||Significance probability for the treatment variable in the Generalized Linear Model|Generalized Estimating Equations|Response variable is oxycodone oral clearance. Explanatory variables include treatment, period and gender, along with their interaction terms.|||
1735164|NCT00499096|3194791|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis||||
1735165|NCT00498940|3194803|Superiority or Other|||||||0.14||||||Differences in cardiac index between groups were assessed by an independent 2-sample t test.|t-test, 2 sided||||
1735166|NCT00498706|3194808|Non-Inferiority or Equivalence|Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.|Mean Difference (Net)|1.07|Standard Deviation|1.695||0.22|2-Sided|95.0|-0.63|2.76|||Mixed Models Analysis|||Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.|
1736596|NCT00481195|3197062|Superiority or Other|||||||0.4438|||||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder|||
1735167|NCT00498706|3194809|Non-Inferiority or Equivalence|Noninferiority is established by showing that the true difference between 2 treatment arms is likely to be smaller than a prespecified noninferiority margin that separates clinically important from clinically negligible (acceptable) differences.|Mean Difference (Net)|-0.09|Standard Deviation|1.26||0.89|2-Sided|95.0|-1.35|1.17|||Mixed Models Analysis|||Longitudinal depression scores were modeled with repeated-measures linear regression models.Time was treated as a categorical variable to account for nonlinear effects of time, and an unstructured covariance matrix was assumed.|
1735168|NCT00498706|3194811|Superiority or Other||Chi-square|7.75||||0.006||95.0|||||Chi-squared||Attrition before week 5 was significantly lower in T-CBT than in face-to-face CBT.||
1735169|NCT00498706|3194811|Superiority or Other||Chi-square|5.83||||0.02||95.0|||||Chi-squared||||
1735170|NCT00498706|3194812|Superiority or Other||t value|-2.95||||0.003||95.0|||||t-test, 2 sided||||
1735171|NCT00498550|3194834|Superiority||difference in treatment means|-4.54|Standard Error of the Mean|2.57||0.088|2-Sided||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.||
1735172|NCT00498485|3194836|Superiority or Other||||||<|0.04|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis = drug-treated would have a higher global impression of change than placebo treated.|
1735173|NCT00497874|3194888|Non-Inferiority or Equivalence|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.13||||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(123) = 1.2||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology—in this case, the t-test—and the results pooled.|
1735174|NCT00497874|3194889|Non-Inferiority or Equivalence|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.05|||||||t-test, 1 sided|t(94) = 1.5||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology—in this case, logistic regression—and the results pooled.|
1735175|NCT00497874|3194890|Non-Inferiority or Equivalence|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.07||||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(57) = 1.5||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology—in this case, logistic regression—and the results pooled.|
1735176|NCT00497874|3194891|Non-Inferiority or Equivalence|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.04||||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(153) = 1.8||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology—in this case, logistic regression—and the results pooled.|
1735177|NCT00497874|3194892|Non-Inferiority or Equivalence|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.002||||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(181) = 2.9||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology—in this case, logistic regression—and the results pooled.|
1735178|NCT00497874|3194893|Non-Inferiority or Equivalence|Power analysis shows that sample size provided power of at least .80 to detect estimated differences.||||||0.003||||||Statistical significance of the pooled results was evaluated using a t-test and degrees of freedom that take into account the uncertainty in the data and the uncertainty due to missing values.|t-test, 1 sided|t(145) = 2.8||Multiple imputation was used to estimate missing data for the 9-month assessment. Ten datasets were imputed using Multivariate Imputation by Chained Equations. Using SAS v9.1 PROC MI, the complete datasets were analyzed using complete data methodology—in this case, the t-test—and the results pooled.|
1735179|NCT00497796|3194901|Superiority or Other||Odds Ratio (OR)|11.165|||<|0.0001|2-Sided|95.0|4.146|30.069||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of initiation of anti-CMV therapy|
1735180|NCT00497796|3194901|Superiority or Other||Odds Ratio (OR)|6.02|||<|0.0001|2-Sided|95.0|3.342|10.843||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia or CMV DNA PCR assay|
1735181|NCT00497796|3194901|Superiority or Other||Odds Ratio (OR)|6.448|||<|0.0001|2-Sided|95.0|3.404|12.213||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of CMV DNA PCR assay|
1735182|NCT00497796|3194901|Superiority or Other||Odds Ratio (OR)|4.041|||<|0.0001|2-Sided|95.0|2.179|7.494||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia assay|
1735183|NCT00497796|3194902|Superiority or Other|||||||0.0007||||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||||
1735363|NCT00494494|3195319|Superiority or Other||Mean Difference (Net)|6.7|Standard Deviation|19.6||0.5066|2-Sided|95.0|-3.12|16.52|||Wilcoxon (Mann-Whitney)||||
1735185|NCT00497796|3194903|Superiority or Other|||||||0.0008||||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel|||Analysis of 100 days post-transplant|
1735186|NCT00497796|3194904|Superiority or Other||Adjusted Hazard Ratio|2.25|||<|0.0001|2-Sided|95.0|1.62|3.14|||Log Rank||Maribavir versus ganciclovir; Cox’s proportional hazards regression model: time = receipt of induction ALA and geographic region (US or Europe) + treatment.|Analysis of time to onset|
1735187|NCT00497796|3194905|Superiority or Other||Odds Ratio (OR)|1.388||||0.2339|2-Sided|95.0|0.811|2.377||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of initiation of anti-CMV therapy|
1735188|NCT00497796|3194905|Superiority or Other||Odds Ratio (OR)|2.177||||0.0053|2-Sided|95.0|1.259|3.767||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of pp65 antigenemia or CMV DNA PCR assay|
1735189|NCT00497796|3194905|Superiority or Other||Odds Ratio (OR)|2.284||||0.0024|2-Sided|95.0|1.338|3.9|||Cochran-Mantel-Haenszel|The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of CMV DNA PCR assay|
1735190|NCT00497796|3194905|Superiority or Other||Odds Ratio (OR)|1.793||||0.0283|2-Sided|95.0|1.065|3.02||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus ganciclovir|Analysis of the pp65 antigenemia assay|
1735191|NCT00497796|3194906|Superiority or Other||Odds Ratio (OR)|1.586||||0.2754|2-Sided|95.0|0.682|3.69||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for receipt of induction ALA and geographic region (US or Europe).|Cochran-Mantel-Haenszel||||
1735192|NCT00497796|3194906|Non-Inferiority or Equivalence|Based on the ICH guidance, the hypothesis of non-inferiority can be tested using a one-sided 97.5% confidence interval’s (CI) upper bound comparing with the non-inferiority margin of 5% (0.05).|Rate difference|0.041|||||2-Sided|95.0|-0.038|0.119|||||Rate difference is the rate of maribavir minus the rate of ganciclovir||
1735193|NCT00497770|3194917|Non-Inferiority or Equivalence|A pre-specified logistic regression was used to assess non-inferiority of DCR in African American participants compared with Caucasian participants. The DCR for African Americans was to be considered non-inferior to the DCR for Caucasians if the upper bound of the confidence interval (CI) of the odds ratio (OR) for African American versus Caucasian was <1.78 which corresponds to a difference in proportions of approximately 14% assuming the DCR in the reference group to be 50%.|Odds Ratio (OR)|0.821|||||2-Sided|95.0|0.427|1.58|||||||
1735194|NCT00497146|3194939|Superiority or Other|||||||0.145|||||||Mixed Models Analysis|Mixed model includes treatment, visit, gender, baseline RAAS inhibitor use, country, baseline value, and treatment by visit interaction.|||
1735195|NCT00497055|3194943|Superiority or Other||||||>=|0|||||||Fisher Exact||||
1735196|NCT00497055|3194944|Superiority or Other|||||||0.31|||||||Wilcoxon (Mann-Whitney)||||
1735197|NCT00497055|3194945|Superiority or Other||Risk Ratio (RR)|0.88||||0.41||95.0|0.66|1.16|||Generalized estimating equation||||
1735198|NCT00496834|3194961|Superiority or Other|||||||0.6574||||||Significance level=0.05|t-test, 2 sided|The secondary efficacy analysis was performed in the modified intention to treat population using t-test|||
1735199|NCT00496834|3194962|Superiority or Other|||||||0.9032||||||Significance level=0.05|t-test, 2 sided|The secondary efficacy analysis was performed in the modified intention to treat population using t-test.|||
1735200|NCT00496834|3194963|Non-Inferiority or Equivalence|non-inferiority margin=-1.5m/s|Mean Difference (Final Values)|-0.36|Standard Deviation|1.4|||2-Sided|95.0|-0.86|0.15|||||The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.|Participants for analysis was per protocol (Number of patients: Losartan group was 54, Carvedilol group was 67). For the primary efficacy endpoints, Per protocol analysis approach was supplementary used.|
1735201|NCT00496834|3194964|Non-Inferiority or Equivalence|non-inferiority margin= -1.5m/s|Mean Difference (Final Values)|-0.41|Standard Deviation|1.43|||2-Sided|95.0|-0.83|0.01|||||The lower limit of ≥-1.5m/s was judged to prove the non-inferiority of the test group to the control group.|Participants for analysis was modified intention to treat (Number of patients: Losartan group was 88, Carvedilol group was 94).|
1735202|NCT00496769|3194986|Other||Hazard Ratio (HR)|1.3||||0.0017|2-Sided|95.0|1.1|1.53|||Log Rank||||
1735203|NCT00496769|3194987|Other||Hazard Ratio (HR)|1.38||||0.0144|2-Sided|95.0|1.07|1.78|||Log Rank||Major or CNRM bleeding||
1735204|NCT00496769|3194987|Other||Hazard Ratio (HR)|1.3||||0.0017|2-Sided|95.0|1.1|1.53|||Log Rank||All bleeding||
1735205|NCT00496769|3194987|Other||Hazard Ratio (HR)|1.54||||0.0716|2-Sided|95.0|0.96|2.45|||Log Rank||Major bleeding||
1735206|NCT00496769|3194988|Superiority||Hazard Ratio (HR)|0.87||||0.36586|2-Sided|95.0|0.65|1.17|||Log Rank||Vascular death||
1735207|NCT00496769|3194988|Superiority||Hazard Ratio (HR)|0.73||||0.0028|2-Sided|95.0|0.6|0.9|||Log Rank||Composite endpoint of major vascular events and major bleeding-net clinical benefit||
1735208|NCT00496769|3194988|Superiority||Hazard Ratio (HR)|0.79||||0.06782|2-Sided|95.0|0.62|1.02|||Log Rank||All-cause death||
1735209|NCT00496769|3194989|Superiority||Hazard Ratio (HR)|0.66||||0.00026|2-Sided|95.0|0.53|0.83|||Log Rank||Vascular death||
1735210|NCT00496769|3194990|Superiority||Hazard Ratio (HR)|0.45|||<|1e-05|2-Sided|95.0|0.32|0.62|||Log Rank||||
1735211|NCT00496730|3194993|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1735212|NCT00496730|3194994|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1735213|NCT00496730|3194995|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1735214|NCT00496626|3194997|Superiority or Other||Seroconversion Rate|96.65|||<=|0||95.0|93.74|98.46||The lower bound of the 95% CI for the seroconversion rate was greater than 90% for each type so the null hypothesis was rejected. The CI reported is for HPV6, the type with the smallest lower bound.|Exact Binomial CI|||The null hypothesis was that the seroconversion rate in the Gardasil® Group was less than 90% for each HPV type.|
1735215|NCT00496626|3194998|Superiority or Other||GMT ratio|101.6|||<=|0|2-Sided|95.0|88.1|117.2||The ANCOVA models showed the lower bounds of two-sided 95% CI on the GMT ratio [GARDASIL™/placebo] were greater than 1 for each HPV type, so the null hypothesis was rejected. The CI reported is for HPV18, the type with the smallest CI lower bound.|ANCOVA||Superiority of GARDASIL™ to placebo was claimed if, for each of the four HPV types, the lower bound of the two-sided 95% CI on the GMT ratio [GARDASIL™/placebo] being >1, or equivalently, the two-sided p-value <0.05.|An Analysis of Covariance (ANCOVA) model was used for each HPV type, based on the pooled data from all age groups and genders. The natural-log-transformed titer was the response variable, and vaccination group, gender and age group were covariates. The null hypothesis was that the GMT ratio (Gardasil/Placebo) was equal to 1.|
1735216|NCT00496262|3195075|Superiority or Other||Mean Difference (Net)|8.9|Standard Deviation|4.4|<|0.0001||90.0|||||2-sided, 1-sample t-test||The entire ITT population was used for a conservative analysis of the mean change in MCF. The mean change was set to 0 for any subject with missing MCF data.|This is an open-label study with statistical comparison between MCF pre-infusion and 1 hour post-infusion.|
1735217|NCT00496197|3195084|Superiority or Other||percentage of participants|67.6|||||2-Sided|95.0|58.9|76.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 6 Follow-up (EOS)|
1735218|NCT00496197|3195085|Superiority or Other||percentage of participants|76.7|||||2-Sided|95.0|69.0|84.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 2 Follow-up|
1735219|NCT00496197|3195086|Superiority or Other||percentage of participants|85.6|||||2-Sided|95.0|79.8|91.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOIV|
1735220|NCT00496197|3195087|Superiority or Other||percentage of participants|82.5|||||2-Sided|95.0|75.7|89.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOT|
1735221|NCT00496197|3195088|Superiority or Other||percentage of participants|93.6|||||2-Sided|95.0|89.7|97.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at Week 6 Follow-up (EOS)|
1735222|NCT00496197|3195089|Superiority or Other||percentage of participants|93.6|||||2-Sided|95.0|89.7|97.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at Week 6 Follow-up (EOS)|
1735223|NCT00496197|3195090|Superiority or Other||percentage of participants|70.1|||||2-Sided|95.0|63.5|76.6|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 6 Follow-up (EOS)|
1735224|NCT00496197|3195091|Superiority or Other||percentage of participants|95.4|||||2-Sided|95.0|92.2|98.5|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at Week 2 Follow-up|
1735225|NCT00496197|3195092|Superiority or Other||percentage of participants|94.8|||||2-Sided|95.0|91.5|98.1|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at Week 2 Follow-up|
1735226|NCT00496197|3195093|Superiority or Other||percentage of participants|76.3|||||2-Sided|95.0|70.3|82.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at Week 2 Follow-up|
1735227|NCT00496197|3195094|Superiority or Other||percentage of participants|92.6|||||2-Sided|95.0|89.3|95.9|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at EOIV|
1735228|NCT00496197|3195095|Superiority or Other||percentage of participants|93.1|||||2-Sided|95.0|89.8|96.4|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at EOIV|
1735229|NCT00496197|3195096|Superiority or Other||percentage of participants|88.5|||||2-Sided|95.0|84.4|92.6|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOIV|
1735230|NCT00496197|3195097|Superiority or Other||percentage of participants|95.3|||||2-Sided|95.0|92.3|98.3|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Microbiological response of Success (eradication or presumed eradication) at EOT|
1735231|NCT00496197|3195098|Superiority or Other||percentage of participants|93.0|||||2-Sided|95.0|89.4|96.7|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Clinical response of Success (cure or improvement) at EOT|
1735232|NCT00496197|3195099|Superiority or Other||percentage of participants|83.7|||||2-Sided|95.0|78.7|88.8|||||95% Confidence interval based on normal approximation to the binomial. Percentages based on the number of participants in analysis.|Global response of Success (cure or improvement) at EOT|
1735233|NCT00496015|3195163|Superiority|Superiority criteria: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) for the difference between groups (Synflorix PRE Group minus Synflorix I Group) was above 0%.|Difference in percentages|22.18|||||2-Sided|95.0|11.78|32.11|||||||
1735234|NCT00495820|3195165|Superiority or Other||||||=|0|||||||Mixed Models Analysis||||
1735235|NCT00495820|3195166|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis||||
1735268|NCT00495469|3195224|Superiority or Other||Mean Difference (Net)|-0.02||||0.889|2-Sided|95.0|-0.34|0.29||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735269|NCT00495469|3195224|Superiority or Other||Mean Difference (Net)|0.1||||0.523|2-Sided|95.0|-0.21|0.42||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735236|NCT00495586|3195195|Non-Inferiority or Equivalence|Equivalence.|Mean Difference (Final Values)|14.2|Standard Deviation|9.5|<|0.05|2-Sided|95.0|3.7|24.3|||Chi-squared|||For the comparison of the efficacy of antibiotic versus placebo, we accepted a null hypothesis if the cure rate in the intervention group was the same or ±7% as that observed in the placebo arm. Based on previous studies, the expected rate of cure among patients assigned to antibiotic therapy was 90%. For an alpha of 0.05 and a beta of 0.2 and accepting possible losses of 15%, we calculated that the sample size is 677 patients in total.|
1735237|NCT00495495|3195209|Superiority or Other||Risk Difference (RD)|0.02||||0.7666|1-Sided|95.0|||||McNemar||||
1735238|NCT00495495|3195210|Superiority or Other||Risk Difference (RD)|0.01||||0.6585|1-Sided|95.0|||||McNemar||||
1735239|NCT00495495|3195211|Superiority or Other|||||||0.0416|||||||McNemar||||
1735240|NCT00495495|3195212|Superiority or Other||Risk Difference (RD)|0.08||||0.9777|1-Sided||||||McNemar||||
1735241|NCT00495495|3195213|Superiority or Other||Risk Difference (RD)|0.02||||0.1126|1-Sided||||||McNemar|||"Null hypothesis: there is no difference between the HealOzone and Placebo devices in the proportion of teeth with lesion progression after 1 year.~Power calculation: the study was sized to have 90% power to detect a 15% difference between treatments in the percentage of teeth with lesion progression at one year (i.e., assuming 45% for the lesions treated with the Placebo device and 30% for the lesions treated with the HealOzone device) with a sample size of 258 subjects completing the study."|
1735242|NCT00495469|3195220|Superiority or Other||Mean Difference (Net)|1.03||||0.086|2-Sided|95.0|-0.15|2.2||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735243|NCT00495469|3195220|Superiority or Other||Mean Difference (Net)|-1.09||||0.069|2-Sided|95.0|-2.26|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735244|NCT00495469|3195220|Superiority or Other||Mean Difference (Net)|-1.45||||0.015|2-Sided|95.0|-2.61|-0.28||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735245|NCT00495469|3195220|Superiority or Other||Mean Difference (Net)|-1.44||||0.017|2-Sided|95.0|-2.61|-0.26||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735246|NCT00495469|3195220|Superiority or Other||Mean Difference (Net)|-1.51||||0.013|2-Sided|95.0|-2.7|-0.33||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735247|NCT00495469|3195220|Superiority or Other||Mean Difference (Net)|-0.5||||0.396|2-Sided|95.0|-1.65|0.66||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735248|NCT00495469|3195221|Superiority or Other||Mean Difference (Net)|-0.4||||0.056|2-Sided|95.0|-0.81|0.01||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735249|NCT00495469|3195221|Superiority or Other||Mean Difference (Net)|-0.13||||0.549|2-Sided|95.0|-0.54|0.29||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735250|NCT00495469|3195221|Superiority or Other||Mean Difference (Net)|-0.23||||0.267|2-Sided|95.0|-0.64|0.18||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735251|NCT00495469|3195221|Superiority or Other||Mean Difference (Net)|-0.36||||0.08|2-Sided|95.0|-0.77|0.04||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735252|NCT00495469|3195221|Superiority or Other||Mean Difference (Net)|-0.34||||0.111|2-Sided|95.0|-0.76|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735253|NCT00495469|3195221|Superiority or Other||Mean Difference (Net)|-0.19||||0.363|2-Sided|95.0|-0.59|0.22||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735254|NCT00495469|3195222|Superiority or Other||Mean Difference (Net)|-0.13||||0.454|2-Sided|95.0|-0.46|0.21||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735255|NCT00495469|3195222|Superiority or Other||Mean Difference (Net)|0.05||||0.783|2-Sided|95.0|-0.29|0.38||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735256|NCT00495469|3195222|Superiority or Other||Mean Difference (Net)|-0.13||||0.446|2-Sided|95.0|-0.46|0.2||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735257|NCT00495469|3195222|Superiority or Other||Mean Difference (Net)|-0.19||||0.261|2-Sided|95.0|-0.52|0.14||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735258|NCT00495469|3195222|Superiority or Other||Mean Difference (Net)|-0.12||||0.495|2-Sided|95.0|-0.46|0.22||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735259|NCT00495469|3195222|Superiority or Other||Mean Difference (Net)|-0.25||||0.143|2-Sided|95.0|-0.58|0.08||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735260|NCT00495469|3195223|Superiority or Other||Mean Difference (Net)|0.11||||0.005|2-Sided|95.0|0.03|0.18||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735261|NCT00495469|3195223|Superiority or Other||Mean Difference (Net)|0.06||||0.154|2-Sided|95.0|-0.02|0.13||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735262|NCT00495469|3195223|Superiority or Other||Mean Difference (Net)|0.07||||0.069|2-Sided|95.0|-0.01|0.14||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735263|NCT00495469|3195223|Superiority or Other||Mean Difference (Net)|0.08||||0.026|2-Sided|95.0|0.01|0.16||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735264|NCT00495469|3195223|Superiority or Other||Mean Difference (Net)|0.04||||0.352|2-Sided|95.0|-0.04|0.11||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735265|NCT00495469|3195223|Superiority or Other||Mean Difference (Net)|0.02||||0.518|2-Sided|95.0|-0.05|0.1||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735266|NCT00495469|3195224|Superiority or Other||Mean Difference (Net)|0.09||||0.581|2-Sided|95.0|-0.22|0.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735267|NCT00495469|3195224|Superiority or Other||Mean Difference (Net)|0.25||||0.124|2-Sided|95.0|-0.07|0.56||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735414|NCT00492752|3195493|Superiority or Other||Disease control rate|0.3533||||||95.0|0.2771|0.4355|||||||
1735270|NCT00495469|3195224|Superiority or Other||Mean Difference (Net)|-0.01||||0.952|2-Sided|95.0|-0.33|0.31||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735271|NCT00495469|3195224|Superiority or Other||Mean Difference (Net)|-0.15||||0.348|2-Sided|95.0|-0.46|0.16||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735272|NCT00495469|3195225|Superiority or Other||Mean Difference (Net)|0.03||||0.863|2-Sided|95.0|-0.32|0.39||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735273|NCT00495469|3195225|Superiority or Other||Mean Difference (Net)|0.24||||0.185|2-Sided|95.0|-0.12|0.6||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735274|NCT00495469|3195225|Superiority or Other||Mean Difference (Net)|0.01||||0.956|2-Sided|95.0|-0.35|0.37||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735275|NCT00495469|3195225|Superiority or Other||Mean Difference (Net)|0.13||||0.483|2-Sided|95.0|-0.23|0.48||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735276|NCT00495469|3195225|Superiority or Other||Mean Difference (Net)|-0.1||||0.604|2-Sided|95.0|-0.46|0.27||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735277|NCT00495469|3195225|Superiority or Other||Mean Difference (Net)|-0.05||||0.767|2-Sided|95.0|-0.4|0.3||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735278|NCT00495469|3195226|Superiority or Other||Mean Difference (Net)|-0.36||||0.072|2-Sided|95.0|-0.76|0.03||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735279|NCT00495469|3195226|Superiority or Other||Mean Difference (Net)|-0.18||||0.393|2-Sided|95.0|-0.58|0.23||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735280|NCT00495469|3195226|Superiority or Other||Mean Difference (Net)|-0.04||||0.845|2-Sided|95.0|-0.44|0.36||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735281|NCT00495469|3195226|Superiority or Other||Mean Difference (Net)|-0.15||||0.452|2-Sided|95.0|-0.54|0.24||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735282|NCT00495469|3195226|Superiority or Other||Mean Difference (Net)|-0.32||||0.131|2-Sided|95.0|-0.73|0.1||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735283|NCT00495469|3195226|Superiority or Other||Mean Difference (Net)|0.2||||0.318|2-Sided|95.0|-0.19|0.59||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change = Baseline + Treatment|||
1735284|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|6.6||||0.01|2-Sided|95.0|1.56|27.99||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (reduction >=1.7 mmol/L)|
1735285|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|13.01|||<|0.001|2-Sided|95.0|3.14|54.0||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (reduction >=1.7 mmol/L)|
1735286|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|6.21|||<|0.012|2-Sided|95.0|1.49|25.83||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (reduction >=1.7 mmol/L)|
1735287|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|2.99|||<|0.142|2-Sided|95.0|0.69|12.86||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (reduction >=1.7 mmol/L)|
1735288|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|4.93|||<|0.03|2-Sided|95.0|1.17|20.87||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction >=1.7 mmol/L)|
1735289|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|2.9|||<|0.179|2-Sided|95.0|0.61|13.75||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (reduction >=1.7 mmol/L)|
1735290|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|2.04|||<|0.211|2-Sided|95.0|0.67|6.24||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (<7.8 mmol/L)|
1735291|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|3.69|||<|0.02|2-Sided|95.0|1.23|11.06||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (<7.8 mmol/L)|
1735292|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|3.12|||<|0.042|2-Sided|95.0|1.04|9.36||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (<7.8 mmol/L)|
1735293|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|2.17|||<|0.169|2-Sided|95.0|0.72|6.53||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (<7.8 mmol/L)|
1735294|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|3.18|||<|0.043|2-Sided|95.0|1.04|9.72||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (<7.8 mmol/L)|
1735295|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|1.85|||<|0.27|2-Sided|95.0|0.62|5.54||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (<7.8 mmol/L)|
1735296|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|4.85|||<|0.012|2-Sided|95.0|1.41|16.66||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (<7 mmol/L)|
1735297|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|4.0|||<|0.024|2-Sided|95.0|1.2|13.27||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (<7 mmol/L)|
1735298|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|2.92|||<|0.082|2-Sided|95.0|0.87|9.78||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (<7 mmol/L)|
1735299|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|2.92|||<|0.087|2-Sided|95.0|0.85|9.96||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (<7 mmol/L)|
1735300|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|4.87|||<|0.011|2-Sided|95.0|1.44|16.46||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (<7 mmol/L)|
1735301|NCT00495469|3195227|Superiority or Other||Odds Ratio (OR)|1.55|||<|0.48|2-Sided|95.0|0.46|5.28||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (<7 mmol/L)|
1735302|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|1.86||||0.264|2-Sided|95.0|0.63|5.49||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (reduction>=0.7%)|
1735303|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|5.31||||0.003|2-Sided|95.0|1.79|15.73||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (reduction>=0.7%)|
1735304|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|4.09||||0.011|2-Sided|95.0|1.38|12.17||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (reduction>=0.7%)|
1735305|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|2.17||||0.162|2-Sided|95.0|0.73|6.44||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction>=0.7%)|
1735306|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|3.87||||0.014|2-Sided|95.0|1.31|11.42||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (reduction>=0.7%)|
1735307|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|2.17||||0.16|2-Sided|95.0|0.74|6.4||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (reduction>=0.7%)|
1735308|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|1.75||||0.369|2-Sided|95.0|0.52|5.88||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (<7%)|
1735309|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|2.81||||0.086|2-Sided|95.0|0.86|9.15||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (<7%)|
1735310|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|1.66||||0.409|2-Sided|95.0|0.5|5.52||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (<7%)|
1735311|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|1.28||||0.687|2-Sided|95.0|0.38|4.3||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (<7%)|
1735312|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|2.74||||0.1|2-Sided|95.0|0.82|9.09||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (<7%)|
1735313|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|1.2||||0.765|2-Sided|95.0|0.36|3.95||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (<7%)|
1735314|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|1.24||||0.795|2-Sided|95.0|0.24|6.29||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs Pioglitazone 30 mg QD: Responders (<=6.5%)|
1735315|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|1.9||||0.409|2-Sided|95.0|0.42|8.68||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg BID: Responders (<=6.5%)|
1735316|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|1.95||||0.382|2-Sided|95.0|0.44|8.75||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 1000 mg QD: Responders (<=6.5%)|
1735317|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|1.13||||0.881|2-Sided|95.0|0.22|5.73||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 500 mg QD: Responders (<=6.5%)|
1735318|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|1.58||||0.58|2-Sided|95.0|0.31|8.01||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 250 mg QD: Responders (<=6.5%)|
1735319|NCT00495469|3195228|Superiority or Other||Odds Ratio (OR)|1.28||||0.757|2-Sided|95.0|0.27|6.06||Pairwise comparison not controlled for multiplicity.|Regression, Logistic|||Placebo vs GSK189075 100 mg QD: Responders (<=6.5%)|
1735320|NCT00495469|3195229|Superiority or Other||Mean Difference (Net)|-13.8||||0.114|2-Sided|95.0|-31.0|3.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735321|NCT00495469|3195229|Superiority or Other||Mean Difference (Net)|-29.5||||0.001|2-Sided|95.0|-46.3|-12.7||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735322|NCT00495469|3195229|Superiority or Other||Mean Difference (Net)|-36.5|||<|0.001|2-Sided|95.0|-53.6|-19.5||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735323|NCT00495469|3195229|Superiority or Other||Mean Difference (Net)|-29.8|||<|0.001|2-Sided|95.0|-46.9|-12.7||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735324|NCT00495469|3195229|Superiority or Other||Mean Difference (Net)|-35.0|||<|0.001|2-Sided|95.0|-52.5|-17.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735325|NCT00495469|3195229|Superiority or Other||Mean Difference (Net)|-24.1|||<|0.005|2-Sided|95.0|-40.9|-7.4||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735326|NCT00495469|3195230|Superiority or Other||Mean Difference (Net)|-0.51||||0.223|2-Sided|95.0|-1.34|0.32||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735327|NCT00495469|3195230|Superiority or Other||Mean Difference (Net)|-1.13||||0.007|2-Sided|95.0|-1.95|-0.32||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735328|NCT00495469|3195230|Superiority or Other||Mean Difference (Net)|-0.95||||0.023|2-Sided|95.0|-1.77|-0.13||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735329|NCT00495469|3195230|Superiority or Other||Mean Difference (Net)|-0.64||||0.131|2-Sided|95.0|-1.46|0.19||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735330|NCT00495469|3195230|Superiority or Other||Mean Difference (Net)|-1.06||||0.013|2-Sided|95.0|-1.89|-0.23||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735331|NCT00495469|3195230|Superiority or Other||Mean Difference (Net)|-0.85||||0.039|2-Sided|95.0|-1.67|-0.04||Pairwise comparison not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735332|NCT00495469|3195232|Superiority or Other||Mean Difference (Net)|-0.19||||0.337|2-Sided|95.0|-0.58|0.2||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735333|NCT00495469|3195232|Superiority or Other||Mean Difference (Net)|-0.59||||0.003|2-Sided|95.0|-0.97|-0.2||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735334|NCT00495469|3195232|Superiority or Other||Mean Difference (Net)|-0.66||||0.001|2-Sided|95.0|-1.05|-0.28||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735335|NCT00495469|3195232|Superiority or Other||Mean Difference (Net)|-0.34||||0.084|2-Sided|95.0|-0.73|0.05||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735336|NCT00495469|3195232|Superiority or Other||Mean Difference (Net)|-0.56||||0.006|2-Sided|95.0|-0.95|-0.16||Pairwise comparison included for informational purposes and not controlled for multiplicity|ANCOVA|Change=Baseline+Treatment|||
1735337|NCT00495469|3195232|Superiority or Other||Mean Difference (Net)|-0.34||||0.085|2-Sided|95.0|-0.73|0.05||Pairwise comparison included for informational purposes and not controlled for multiplicity.|ANCOVA|Change=Baseline+Treatment|||
1735338|NCT00495469|3195232|Other|Tukey’s trend test for dose response||||||0.085||||||Tukey’s trend test adjusts for multiplicity with statistical significance based on p-value <0.05.|ANCOVA|Change=Baseline+Treatment|||
1735339|NCT00495469|3195232|Other|Tukey’s trend test for dose response||||||0.006||||||Tukey’s trend test adjusts for multiplicity with statistical significance based on p-value <0.05.|ANCOVA|Change=Baseline+Treatment|||
1735340|NCT00495469|3195232|Other|Tukey’s trend test for dose response||||||0.047||||||Tukey’s trend test adjusts for multiplicity with statistical significance based on p-value <0.05.|ANCOVA|Change=Baseline+Treatment|||
1735341|NCT00495469|3195232|Other|Tukey’s trend test for dose response||||||0.003||||||Tukey’s trend test adjusts for multiplicity with statistical significance based on p-value <0.05|ANCOVA|Change=Baseline+Treatment|||
1735342|NCT00495131|3195254|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Null hypothesis: no difference between 2 groups SVR estimation: 24 weeks (60%), 48 weeks (75%) alfa erros: 0.05, power: 0.80|
1735343|NCT00494975|3195262|Superiority or Other||Mean Difference (Final Values)|0.94|Standard Error of the Mean|0.32|<|0.05|2-Sided|95.0|0.31|1.56|||generalized estimating equations (GEE)|||The VAS score of pruritus intensity was recorded for each participant at baseline and weekly until week 12 so that each one had 12 repeatedly measured data scores. To investigate the predictive effects of age, sex, comorbid diseases, phototherapy, and results of blood laboratory exams on the intensity of pruritus, marginal linear regression model was fitted to the repeatedly measured VAS score data using the generalized estimating equations (GEE) method.|
1735344|NCT00494871|3195263|Superiority or Other||Hazard Ratio (HR)|1.2|||||2-Sided|95.0|0.92|1.56|||||||
1735345|NCT00494871|3195264|Superiority or Other||Hazard Ratio (HR)|0.85|||||2-Sided|95.0|0.5|1.43|||||||
1735346|NCT00494871|3195265|Superiority or Other||Hazard Ratio (HR)|1.37|||||2-Sided|95.0|0.43|4.31|||||||
1735347|NCT00494871|3195266|Superiority or Other||Hazard Ratio (HR)|0.48|||||2-Sided|95.0|0.16|1.4|||||||
1735348|NCT00494871|3195267|Superiority or Other||Hazard Ratio (HR)|2.97|||||2-Sided|95.0|0.6|14.7|||||||
1735349|NCT00494871|3195268|Superiority or Other||Hazard Ratio (HR)|2.93|||||2-Sided|95.0|0.3|28.16|||||||
1735350|NCT00494871|3195269|Superiority or Other||Hazard Ratio (HR)|0.99|||||2-Sided|95.0|0.06|15.85|||||||
1735351|NCT00494871|3195270|Superiority or Other||Hazard Ratio (HR)|0.46|||||2-Sided|95.0|0.22|0.98|||||||
1735352|NCT00494871|3195271|Superiority or Other||Hazard Ratio (HR)|0.74|||||2-Sided|95.0|0.41|1.34|||||||
1735353|NCT00494871|3195272|Superiority or Other||Hazard Ratio (HR)|0.65|||||2-Sided|95.0|0.34|1.22|||||||
1735354|NCT00494871|3195273|Superiority or Other||Hazard Ratio (HR)|0.49|||||2-Sided|95.0|0.24|1.0|||||||
1735355|NCT00494871|3195274|Non-Inferiority or Equivalence|Non-inferiority margin of 2.0|Hazard Ratio (HR)|1.11||||0.025|2-Sided|95.0|0.87|1.42|||Regression, Cox||||
1735356|NCT00494806|3195275|Superiority or Other||Mean Difference (Final Values)|0.7279|Standard Error of the Mean|0.15|<|0.05||95.0|0.3174|1.1383|||t-test, 2 sided|df = 64|Relative risk not calculated.|"No differences in time to first flatus between the rocking and non rocking groups is the null hypothesis.~Sample size calculations by setting the criterion for significance at .05, two-tailed test (an effect in either directions was accepted), and power at .80. A total sample of 54 participants was determined necessary to yield statistically significant results (27 in Group A and 27 in Group B)."|
1735357|NCT00494676|3195292|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Deviation|2.1|=|0|2-Sided|95.0|-1.2|0.3|||t-test, 2 sided||||
1735358|NCT00494676|3195293|Superiority or Other||Mean Difference (Final Values)|1.9|Standard Deviation|2.7|=|0|2-Sided|95.0|0.7|3.0|||t-test, 2 sided||||
1735359|NCT00494676|3195294|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Deviation|2.6|=|0|2-Sided|95.0|-0.1|1.3|||t-test, 2 sided|||Mobility improvement scores were normally distributed. A paired t-test was used to conduct a within-subjects comparison of the crossover differences in mobility scores between real and sham prism glasses. An alpha level of 5% was used to indicate statistical significance for secondary analyses|
1735360|NCT00494676|3195295|Superiority or Other||Odds Ratio (OR)|5.2|||=|0|2-Sided|95.0|1.8|21.0|||McNemar||The marginal odds ratio based on discordant pairs was computed.|The analysis used a McNemar test for data combined across both periods of the crossover. We estimated that 70% and 35% of participants would say yes to the real and sham prisms, respectively. For a 2-tailed test, the minimum sample size to detect a 35% difference in yes responses to real and sham prisms was 57 participants, assuming 30% overlap (30% said yes to both pairs of glasses), power of 90% and α of 1%. Assuming an attrition rate of 20%, we planned to enroll 68 participants.|
1735361|NCT00494494|3195317|Superiority or Other||Mean Difference (Net)|1.03|Standard Deviation|5.64||0.5005|2-Sided|95.0|-1.49|3.55|||Wilcoxon (Mann-Whitney)||||
1735362|NCT00494494|3195318|Superiority or Other||Mean Difference (Net)|0.05|Standard Deviation|0.21||0.5099|2-Sided|95.0|-0.13|0.227|||Wilcoxon (Mann-Whitney)||||
1738473|NCT00457197|3200382|Superiority or Other|||||||0.7071|||||||ANCOVA|||Baseline HRSD used as covariate.|
1735364|NCT00494494|3195320|Superiority or Other||Mean Difference (Net)|2.01|Standard Deviation|9.56||0.1937|2-Sided|95.0|-2.41|6.43|||Wilcoxon (Mann-Whitney)||||
1735365|NCT00494494|3195321|Non-Inferiority or Equivalence|Our estimate of a clinically relevant increase is 25 microns. With these specifications, the sample size that is required to have 0.90 power for the comparison between two groups at the two-sided 0.05 significance level is about 10 per group.|Mean Difference (Net)|2.82|Standard Deviation|13.8||0.7029|2-Sided|95.0|-3.27|8.91|||Wilcoxon (Mann-Whitney)|||The null hypothesis is that there is no correlation between the 2 groups. Standard methods were used for power calculation to determine the sample size needed to have 0.90 power for the comparison between two groups at the two-sided significance of 0.05.|
1735366|NCT00494299|3195330|Superiority or Other||Hazard Ratio (HR)|0.8735||||||95.0|0.6972|1.0942|||||Hazard Ratio: Sorafenib/Placebo.||
1735367|NCT00494299|3195330|Superiority or Other||Log Rank|0.2520462|||||||||||||The comparison between the 2 groups is done using the log rank test stratified by the response of TACE (Responder group A versus Responder group B), ECOG performance status (PS) (0 versus 1) and the number of prior TACE (1 versus 2).||
1735368|NCT00494013|3195362|Superiority or Other|||||||0.026|||||||Fisher Exact||||
1735369|NCT00494013|3195363|Superiority or Other|||||||0.039|||||||ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.|||
1735370|NCT00494013|3195364|Superiority or Other|||||||0.074|||||||ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group + Change in HbA1c from Baseline.|||
1735371|NCT00494013|3195365|Non-Inferiority or Equivalence|Noninferiority margin of 1.5 kilograms (kg).|Mean Difference (Net)|1.5|||<|0.001||95.0|0.93|2.06||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|The second gatekeeping hypothesis was that Insulin Lispro Protamine Suspension was noninferior to detemir with regard to change in absolute body weight from baseline to endpoint (last observation carried forward).|
1735372|NCT00494013|3195367|Superiority or Other|||||||0.226||||||P-value for Severe Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1735373|NCT00494013|3195367|Superiority or Other|||||||0.001||||||P-value for Nocturnal Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1735374|NCT00494013|3195367|Superiority or Other|||||||0.001||||||P-value for Hypoglycemic Rate.|ANOVA|Nonparametric ANOVA Model: Rank of Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1735375|NCT00494013|3195368|Superiority or Other|||||||0.45||||||P-value for Severe Hypoglycemic Events.|Fisher Exact||||
1735376|NCT00494013|3195368|Superiority or Other|||||||0.005||||||P-value for Nocturnal Hypoglycemic Events.|Fisher Exact||||
1735377|NCT00494013|3195368|Superiority or Other|||||||0.472||||||P-value for All Hypoglycemic Events.|Fisher Exact||||
1735378|NCT00494013|3195369|Superiority or Other|||||||0.632||||||P-value for Average Morning+Evening Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1735379|NCT00494013|3195369|Superiority or Other|||||||0.79||||||P-value for Average Post-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1735380|NCT00494013|3195369|Superiority or Other|||||||0.856||||||P-value for Average Pre-Meal.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1735381|NCT00494013|3195369|Superiority or Other|||||||0.952||||||P-value for Average 7-Point SMBG.|ANOVA|ANOVA Model: Variable = Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|||
1735382|NCT00494013|3195370|Non-Inferiority or Equivalence|Noninferiority margin of 0.8 millimoles per Liter (mmol/L).|Mean Difference (Net)|0.1||||0.107||95.0|-0.02|0.23|||ANOVA|ANOVA model: Variable=Treatment + Country + Baseline HbA1c + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|The first gatekeeping hypothesis was that Insulin Lispro Protamine Suspension was noninferior to determir.|
1735383|NCT00494013|3195371|Superiority or Other|||||||0.135||||||P-value for HbA1c ≤6.5%.|Fisher Exact||||
1735384|NCT00494013|3195371|Superiority or Other|||||||0.463||||||P-value for HbA1c <7.0%.|Fisher Exact||||
1735385|NCT00494013|3195372|Superiority or Other||Mean Difference (Net)|-0.2||||0.038||95.0|-0.38|-0.01||P-value for Week 24 HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).||
1735386|NCT00494013|3195372|Superiority or Other||Mean Difference (Net)|-0.2||||0.038||95.0|-0.38|-0.01||P-value for 24 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).||
1735387|NCT00494013|3195372|Superiority or Other||Mean Difference (Net)|-0.11||||0.213||95.0|-0.28|0.06||P-value for 12 Week HbA1c.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).||
1735388|NCT00494013|3195372|Superiority or Other||Mean Difference (Net)|-0.11||||0.213||95.0|-0.28|0.06||P-value for 12 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable = Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sides 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Detemir).||
1735415|NCT00492752|3195494|Superiority or Other||Hazard Ratio (HR)|0.5375||||0.00054||95.0|0.3763|0.7677|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo||
1735416|NCT00492752|3195494|Superiority or Other||Hazard Ratio (HR)|0.5744||||0.000537||95.0|0.4154|0.7942|||Log Rank||Hazard ratio is for Sorafenib vs placebo||
1735417|NCT00492752|3195495|Superiority or Other||Hazard Ratio (HR)|0.8831||||0.437926||95.0|0.6449|1.2093|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo||
1735389|NCT00494013|3195373|Non-Inferiority or Equivalence|The noninferiority margin was 0.4%.|Mean Difference (Net)|-0.21||||0.026||95.0|-0.39|-0.03|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country + Baseline Sulfonylurea Group.|The two-sided 95% confidence interval is for the Least Squares Mean difference between the two treatments (Insulin Lispro Protamine Suspension minus Determir).|Hypothesis: Basal analog insulin lispro protamine suspension, injected once or twice daily is noninferior to basal analog insulin determir, injected once or twice daily, with regard to glycemic control as measured by change in HbA1c from baseline to endpoint (last observation carried forward).|
1735390|NCT00493974|3195374|Superiority or Other (legacy)|||||||0.006|||||||t-test, 2 sided||||
1735391|NCT00493974|3195375|Superiority or Other (legacy)||||||<|0.0001|||||||t-test, 2 sided||||
1735392|NCT00493974|3195376|Superiority or Other (legacy)|||||||0.4957|||||||t-test, 2 sided||||
1735393|NCT00493974|3195377|Superiority or Other (legacy)|||||||0.63|||||||Chi-squared||||
1735394|NCT00493974|3195378|Superiority or Other (legacy)|||||||0.6433|||||||Wilcoxon (Mann-Whitney)||||
1735395|NCT00493974|3195379|Superiority or Other (legacy)|||||||0.6413|||||||Wilcoxon (Mann-Whitney)||||
1735396|NCT00493974|3195380|Superiority or Other (legacy)|||||||0.3876|||||||Wilcoxon (Mann-Whitney)||||
1735397|NCT00493220|3195444|Non-Inferiority or Equivalence|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|105.1|||||2-Sided|90.0|101.87|108.42|||||Placebo SC/Intravenous||
1735398|NCT00493220|3195444|Non-Inferiority or Equivalence|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|106.95|||||2-Sided|90.0|103.67|110.33|||||HYLENEX SC/Intravenous||
1735399|NCT00493220|3195444|Non-Inferiority or Equivalence|Bioequivalence = 95% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|101.76|||||2-Sided|90.0|98.64|104.98|||||HYLENEX SC/Placebo SC||
1735400|NCT00493220|3195445|Non-Inferiority or Equivalence|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|104.71|||||2-Sided|90.0|101.59|107.92|||||Placebo SC/Intravenous||
1735401|NCT00493220|3195445|Non-Inferiority or Equivalence|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|106.79|||||2-Sided|90.0|103.61|110.07|||||HYLENEX SC/Intravenous||
1735402|NCT00493220|3195445|Non-Inferiority or Equivalence|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|101.99|||||2-Sided|90.0|98.95|105.12|||||HYLENEX SC/Placebo SC||
1735403|NCT00493220|3195446|Superiority or Other||Median Difference (Net)|2.52|||<|0.01|2-Sided|90.0|2.26|2.76|||Wilcoxon signed-rank test||Placebo SC minus Intravenous||
1735404|NCT00493220|3195446|Superiority or Other||Median Difference (Net)|1.52|||<|0.01|2-Sided|90.0|1.27|1.71|||Wilcoxon signed-rank test||Placebo SC minus Intravenous||
1735405|NCT00493220|3195446|Superiority or Other||Median Difference (Net)|-1.0|||<|0.01|2-Sided|90.0|-1.25|-0.75|||Wilcoxon signed-rank test||HYLENEX SC minus Placebo SC||
1735406|NCT00493220|3195447|Non-Inferiority or Equivalence|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (%; ln-transformed)|54.4|||||2-Sided|90.0|52.82|56.01|||||Placebo SC/Intravenous||
1735407|NCT00493220|3195447|Non-Inferiority or Equivalence|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (natural log-transformed)|60.81|||||2-Sided|90.0|59.06|62.62|||||HYLENEX SC/Intravenous||
1735408|NCT00493220|3195447|Non-Inferiority or Equivalence|Bioequivalence = 90% confidence interval of least squares mean (LSM) within 80%-125%|LSM ratio (natural log-transformed)|111.79|||||2-Sided|90.0|108.57|115.12|||||HYLENEX SC/Placebo SC||
1735409|NCT00493038|3195453|Non-Inferiority or Equivalence|The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: ”Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference...”, pg.1447-1454 [1990]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population.|Mean Difference (Final Values)|1.7||||||95.0|-3.8|7.1||||||Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)|
1735410|NCT00493038|3195454|Non-Inferiority or Equivalence|The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: ”Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference...”, pg.1447-1454 [1990]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population.|Mean Difference (Final Values)|-0.5||||||95.0|-7.9|6.8||||||Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)|
1735411|NCT00493038|3195455|Non-Inferiority or Equivalence|The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: ”Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference...”, pg.1447-1454 [1990]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 80% in the per protocol population.|Mean Difference (Final Values)|2.1||||||95.0|-1.9|6.2|||||Mean difference denotes the difference of clinical cure rates between the two treatment groups (moxifloxacin minus amoxicillin/clavulanate).|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)|
1735412|NCT00492752|3195490|Superiority or Other|||||||0.67|||||||Fisher Exact|based on tumor response rate (CR+PR)|||
1735413|NCT00492752|3195493|Superiority or Other||Disease control rate|0.1579||||||95.0|0.0843|0.2596|||||||
1735419|NCT00492752|3195496|Superiority or Other||Hazard Ratio (HR)|0.6208||||0.003464||95.0|0.4498|0.8568|||Log Rank|log rank test stratified by country, tumor burden, and ECOG.|Hazard ratio is for Sorafenib vs placebo||
1735420|NCT00492752|3195496|Superiority or Other||Hazard Ratio (HR)|0.6783||||0.014144||95.0|0.4962|0.9272|||Log Rank||Hazard ratio is for Sorafenib vs placebo.||
1735421|NCT00492726|3195500|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|-2.9||||||95.0|-7.6|1.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).|
1735422|NCT00492726|3195501|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.8||||||95.0|-9.0|1.5|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without super- or reinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).|
1735423|NCT00492726|3195502|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.9||||||95.0|-8.8|1.0|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).|
1735424|NCT00492726|3195503|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|-1.5||||||95.0|-5.0|1.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).|
1735425|NCT00492726|3195504|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference in bact. success rates (in %)|-3.9||||||95.0|-8.8|1.0|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. Presumed eradications and eradications without superinfection were considered bacteriological successes.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).|
1735426|NCT00492726|3195505|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference in improvement rates (in %)|1.1||||||95.0|-0.4|2.7|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).|
1735427|NCT00492726|3195506|Non-Inferiority or Equivalence|The non-inferiority margin was set to 10% in the protocol, in agreement with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population.|Difference of cure rates (in percent)|-3.8||||||95.0|-7.9|0.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator).|
1735428|NCT00492622|3195518|Equivalence|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.||||||0.95||||||An analysis of variance model was used to compare AUC between IR and DR omeprazole using the natural logarithmic transformation. The model included the following factors: treatment, period, sequence and patient nested within the sequence.|ANOVA||||
1735429|NCT00492622|3195519|Equivalence|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.|||||||||||||||||P<0.05 was used as the level of significance with ANOVA for this endpoint.
1735430|NCT00492622|3195520|Equivalence|Primary study objective was to compare the pharmacokinetics of omeprazole between IR and DR omeprazole in patients with GERD associated with gastroparesis.|||||<|0.01||||||<0.01 is used for determining the level of significance.|paired t-tests||||
1735431|NCT00492557|3195522|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||2-Sided|95.0|0.54|1.27|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 23F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735432|NCT00492557|3195522|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||2-Sided|95.0|0.57|1.16|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735433|NCT00492557|3195522|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||2-Sided|95.0|0.61|1.12|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735434|NCT00492557|3195522|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||2-Sided|95.0|0.59|1.14|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 18C. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735435|NCT00492557|3195522|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||2-Sided|95.0|0.65|1.24|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 14. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735436|NCT00492557|3195522|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||2-Sided|95.0|0.42|1.03|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 9V. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735437|NCT00492557|3195522|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||2-Sided|95.0|0.47|1.12|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 7F. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735438|NCT00492557|3195522|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||2-Sided|95.0|0.55|1.09|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6B. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735439|NCT00492557|3195522|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.8|||||2-Sided|95.0|0.54|1.08|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6A. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735440|NCT00492557|3195522|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|1.1|||||2-Sided|95.0|0.77|1.6|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 5. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735441|NCT00492557|3195522|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.7|||||2-Sided|95.0|0.47|0.95|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 4. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735442|NCT00492557|3195522|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||2-Sided|95.0|0.69|1.2|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 3. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735443|NCT00492557|3195522|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was if the lower limit of the 2-sided 95%CI for the GMT ratios, (13vPnC+TIV relative to 13vPnC administered 1 month after TIV+placebo) was greater than 0.5 (2-fold criterion).|GMT Ratio|0.9|||||2-Sided|95.0|0.68|1.24|||||2-sided 95% CIs for the GMT ratio were calculated by back transformations of the 95% CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 1. The primary null hypothesis was: the log of the GMT in the group receiving 13vPnC + TIV minus the log of the GMT in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735505|NCT00491764|3195622|Superiority or Other||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1736597|NCT00481195|3197063|Superiority or Other|||||||0.5066|||||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder|||
1735444|NCT00492557|3195525|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.95|||||2-Sided|95.0|0.71|1.27|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 23F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735445|NCT00492557|3195525|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.65|||||2-Sided|95.0|0.49|0.85|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735446|NCT00492557|3195525|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.7|||||2-Sided|95.0|0.56|0.87|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 19A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735447|NCT00492557|3195525|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.8|||||2-Sided|95.0|0.64|1.01|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 18C. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735448|NCT00492557|3195525|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.72|||||2-Sided|95.0|0.53|0.97|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 14. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735449|NCT00492557|3195525|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.8|||||2-Sided|95.0|0.63|1.02|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 9V. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735450|NCT00492557|3195525|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.84|||||2-Sided|95.0|0.67|1.07|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 7F. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735451|NCT00492557|3195525|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.97|||||2-Sided|95.0|0.75|1.25|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6B. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735452|NCT00492557|3195525|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.76|||||2-Sided|95.0|0.61|0.94|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 6A. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735453|NCT00492557|3195525|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.69|||||2-Sided|95.0|0.55|0.86|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 5. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735454|NCT00492557|3195525|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.66|||||2-Sided|95.0|0.51|0.87|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 4. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735471|NCT00492232|3195590|Superiority or Other||Mean Difference (Final Values)|0.17||||0.541||95.0|-0.39|0.74||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs >10 mg), baseline zolpidem frequency, and pooled center as covariates.|||
1741663|NCT00432809|3203961|Superiority or Other||||||<|0.001|||||||ANOVA||||
1735455|NCT00492557|3195525|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.94|||||2-Sided|95.0|0.78|1.13|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 3. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735456|NCT00492557|3195525|Non-Inferiority or Equivalence|The criterion upon which to declare non-inferiority was the lower bound of the 2-sided, 95% CI for the geometric mean ratio greater than 0.5 (2-fold criterion).|Ratio of GMCs|0.79|||||2-Sided|95.0|0.6|1.04|||||CIs for the ratio were back transformations of the CIs based on the Student t distribution for the mean difference of the logarithmically transformed assay results.|Serotype 1. The primary null hypothesis was: the log of the GMC in the group receiving 13vPnC and TIV concomitantly, minus the log of the GMC in the group receiving 13vPnC alone (1 month after TIV) <= -0.693.|
1735457|NCT00492557|3195526|Non-Inferiority or Equivalence|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV – TIV alone) was greater than –0.10.|Percent Difference|-1.8|||||2-Sided|95.0|-7.8|4.1||||||Influenza virus subtype: B. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) <= -0.10.|
1735458|NCT00492557|3195526|Non-Inferiority or Equivalence|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% CI, computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV – TIV alone) was greater than –0.10.|Percent Difference|-4.6|||||2-Sided|95.0|-10.4|1.3||||||Influenza virus subtype: A/H3N2. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) <= -0.10.|
1735459|NCT00492557|3195526|Non-Inferiority or Equivalence|Non-inferiority for a given virus subtype was demonstrated if the lower bound of the 2-sided, 95% confidence interval (CI), computed using the Chan and Zhang procedure, for the difference in proportions (13vPnC+TIV – TIV alone) was greater than –0.10.|Percent Difference|1.7|||||2-Sided|95.0|-3.1|6.5||||||Influenza virus subtype: A/H1N1. Primary null hypothesis for each of the influenza virus subtypes is: proportion of participants achieving a 4-fold increase in titer when 13vPnC+TIV were administered concomitantly, minus the proportion of participants achieving a 4-fold increase in titer when TIV was administered alone (with placebo) <= -0.10.|
1735460|NCT00492531|3195536|Superiority or Other||Mean Difference (Net)|-9.0||||0.7|2-Sided|95.0|-56.0|38.0|||ANCOVA|6 minute walk was based on ANCOVA model with treatment as a fixed effect and 6 minute walk distance, TRV stratum and study site as covariate.|||
1735461|NCT00492401|3195542|Superiority or Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Expression levels of DNMT3a in pre treatment marrow samples from responding or non responding patients were compared using Wilcoxon rank sum tests|
1735462|NCT00492401|3195542|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Expression levels of miR-29b in pre treatment marrow samples from responding or non responding patients were compared using Wilcoxon rank sum tests|
1735463|NCT00492349|3195546|Superiority or Other (legacy)||||||<|0.05|||||||ANCOVA|||Mixed model ANCOVA in which baseline Antisaccade Errors served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.|
1735464|NCT00492349|3195547|Superiority or Other (legacy)||||||>|0.05||||||All treatment main and interaction effect p-values were > 0.05.|ANCOVA|||Mixed model ANCOVA in which baseline CPT Detectability served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.|
1735465|NCT00492349|3195548|Superiority or Other (legacy)||||||<|0.05|||||||ANCOVA|||Mixed model ANCOVA in which baseline served as the covariate and Smoking status and measurement occasions were between and within-groups factors, respectively.|
1735466|NCT00492232|3195584|Superiority or Other||Adjusted Odds Ratio|1.42||||0.389||95.0|0.64|3.13||P-values are from Chi-square tests of the log-regression model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using logistic regression analysis adjusted for effects of baseline zolpidem dosage (≤10 mg vs >10 mg).|||
1735467|NCT00492232|3195585|Superiority or Other||Adjusted Odds Ratio|2.01||||0.284||95.0|0.55|7.34||P-values are from Chi-square tests of the log-regression model for the overall treatment comparison. Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using logistic regression analysis adjusted for effects of baseline zolpidem dosage (≤10 mg vs >10 mg).|||
1735468|NCT00492232|3195587|Superiority or Other||Mean Difference (Final Values)|0.12||||0.82||95.0|-0.93|1.17||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs >10 mg), baseline zolpidem frequency, and pooled center as covariates.|||
1735469|NCT00492232|3195588|Superiority or Other||Mean Difference (Final Values)|0.15||||0.757||95.0|-0.79|1.08||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs >10 mg), baseline zolpidem frequency, and pooled center as covariates.|||
1735470|NCT00492232|3195589|Superiority or Other||Mean Difference (Final Values)|0.55||||0.163||95.0|-0.23|1.33||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs >10 mg), baseline zolpidem frequency, and pooled center as covariates.|||
1735502|NCT00491764|3195621|Superiority or Other||Mean Difference (Net)|64.9|||<|0.001||95.0|49.5|80.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735472|NCT00492232|3195591|Superiority or Other||Mean Difference (Final Values)|0.09||||0.617||95.0|-0.27|0.45||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs >10 mg), baseline zolpidem frequency, and pooled center as covariates.|||
1735473|NCT00492232|3195592|Superiority or Other||Mean Difference (Final Values)|0.1||||0.965||95.0|-6.28|6.56||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs >10 mg) and pooled center as covariates.|||
1735474|NCT00492232|3195593|Superiority or Other||Mean Difference (Final Values)|-2.2||||0.517||95.0|-9.09|4.6||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs >10 mg) and pooled center as covariates.|||
1735475|NCT00492232|3195594|Superiority or Other||Mean Difference (Final Values)|2.0||||0.538||95.0|-4.32|8.23||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs >10 mg) and pooled center as covariates.|||
1735476|NCT00492232|3195595|Superiority or Other||Mean Difference (Final Values)|0.4||||0.901||95.0|-5.31|6.03||P-values are from t-tests of the ANCOVA model for the difference in LS means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs >10 mg) and pooled center as covariates.|||
1735477|NCT00492232|3195596|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.946||95.0|-6.23|5.81||P-values are from t-tests of the analysis of covariance (ANCOVA) model for the difference in least squares (LS) means between treatments. Statistical significance was determined at the 0.05 level.|ANCOVA|LS means are from an ANCOVA model with baseline zolpidem dosage (≤10 mg vs >10 mg) and pooled center as covariates.|||
1735478|NCT00492232|3195597|Superiority or Other||Adjusted Odds Ratio|0.71||||0.484||95.0|0.27|1.85||Statistical significance was determined at the 0.05 level.|Regression, Logistic|Log odds of achieving response were estimated using the logistic regression analysis adjusted for effects of treatment and pooled center.|||
1735479|NCT00492063|3195606|Non-Inferiority or Equivalence|The value of GMR ratio of cTIV to TIV is >0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.27|||||2-Sided|95.0|1.11|1.4||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.|
1735480|NCT00492063|3195606|Non-Inferiority or Equivalence|The value of GMR ratio of cTIV to TIV is >0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.87|||||2-Sided|95.0|0.74|1.02||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.|
1735481|NCT00492063|3195606|Non-Inferiority or Equivalence|The value of GMR ratio of cTIV to TIV is >0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.96|||||2-Sided|95.0|0.82|1.12||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.|
1735482|NCT00492063|3195606|Non-Inferiority or Equivalence|The value of GMR ratio of cTIV to TIV is >0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.14|||||2-Sided|95.0|0.99|1.3||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.|
1735483|NCT00492063|3195606|Non-Inferiority or Equivalence|The value of GMR ratio of cTIV to TIV is >0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|0.85|||||2-Sided|95.0|0.72|0.99||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.|
1735484|NCT00492063|3195606|Non-Inferiority or Equivalence|The value of GMR ratio of cTIV to TIV is >0.5 (i.e., the GMR of the cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI for ratio of GMRs at day 22 is greater than 0.5).|Ratio of GMRs|1.07|||||2-Sided|95.0|0.9|1.28||||||Non-inferiority testing in immune response (GMR) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.|
1735485|NCT00492063|3195607|Non-Inferiority or Equivalence|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|6.0|||||2-Sided|95.0|2.0|11.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in the elderly population.|
1735486|NCT00492063|3195607|Non-Inferiority or Equivalence|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|3.0|||||2-Sided|95.0|-2.0|8.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in the elderly population.|
1735503|NCT00491764|3195621|Superiority or Other||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735504|NCT00491764|3195622|Superiority or Other||Mean Difference (Net)|54.3|||<|0.001||95.0|37.8|70.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735487|NCT00492063|3195607|Non-Inferiority or Equivalence|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|0.0|||||2-Sided|95.0|-6.0|5.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in the elderly population.|
1735488|NCT00492063|3195607|Non-Inferiority or Equivalence|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|4.0|||||2-Sided|95.0|0.0|8.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain B in adults.|
1735489|NCT00492063|3195607|Non-Inferiority or Equivalence|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|-1.0|||||2-Sided|95.0|-6.0|4.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H3N2 in adults.|
1735490|NCT00492063|3195607|Non-Inferiority or Equivalence|The percentage of subjects with seroconversion or significant increase in HI titer in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with seroconversion or significant in HI titer of cTIV group is non-inferior to that of the TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%).|Group difference|2.0|||||2-Sided|95.0|-3.0|7.0||||||Non-inferiority testing in immune response (seroconversion or significant increase in HI titer) after one vaccination of cTIV to that of TIV vaccine for strain A/H1N1 in adults.|
1735491|NCT00492063|3195608|Non-Inferiority or Equivalence|The percentage of subjects with HI titer ≥40 in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|1.0|||||2-Sided|95.0|-2.0|4.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in the elderly population.|
1735492|NCT00492063|3195608|Non-Inferiority or Equivalence|The percentage of subjects with HI titer ≥40 in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|-1.0|||||2-Sided|95.0|-2.0|1.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in the elderly population.|
1735493|NCT00492063|3195608|Non-Inferiority or Equivalence|The percentage of subjects with HI titer ≥40 in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|-1.0|||||2-Sided|95.0|-4.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in the elderly population.|
1735494|NCT00492063|3195608|Non-Inferiority or Equivalence|The percentage of subjects with HI titer ≥40 in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain B, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||2-Sided|95.0|-3.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain B after one vaccination in adults.|
1735495|NCT00492063|3195608|Non-Inferiority or Equivalence|The percentage of subjects with HI titer ≥40 in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H3N2, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||2-Sided|95.0|-1.0|2.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H3N2 after one vaccination in adults.|
1735496|NCT00492063|3195608|Non-Inferiority or Equivalence|The percentage of subjects with HI titer ≥40 in the cTIV group is >10% lower than in the TIV group (i.e., the percentage of subjects with HI titer ≥40 in the cTIV group is non-inferior to that of TIV group if, for strain A/H1N1, the lower limit of the 95% CI of the difference in the percentages is greater than -10%)|Group difference|0.0|||||2-Sided|95.0|-3.0|3.0||||||Non-inferiority testing in immune response (HI titer ≥40) of cTIV to that of TIV vaccine for strain A/H1N1 after one vaccination in adults.|
1735497|NCT00492024|3195609|Superiority or Other|||||||0.075||||||p-value adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)|Cochran-Mantel-Haenszel|adjusted for study center||Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo|
1735498|NCT00492024|3195614|Superiority or Other|||||||0.189||||||P-value is adjusted for study center; p-value applies to percentage of subjects with success (clinical cure)|Cochran-Mantel-Haenszel|Adjusted for study center||Null hypothesis is that the success rate for moxifloxacin = the success rate for placebo|
1735499|NCT00491764|3195621|Superiority or Other||Mean Difference (Net)|57.1|||<|0.001||95.0|40.7|73.5|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735500|NCT00491764|3195621|Superiority or Other||Mean Difference (Net)|31.4|||<|0.001||95.0|16.0|46.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735501|NCT00491764|3195621|Superiority or Other||Mean Difference (Net)|66.7|||<|0.001||95.0|50.6|82.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735506|NCT00491764|3195622|Superiority or Other||Mean Difference (Net)|48.5|||<|0.001||95.0|31.4|65.5|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735507|NCT00491764|3195622|Superiority or Other||Mean Difference (Net)|64.9|||<|0.001||95.0|49.5|80.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735508|NCT00491764|3195622|Superiority or Other||Mean Difference (Net)|25.7|||<|0.002||95.0|11.2|40.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735509|NCT00491764|3195623|Superiority or Other||Mean Difference (Net)|37.1|||<|0.001||95.0|21.1|53.2|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735510|NCT00491764|3195623|Superiority or Other||Mean Difference (Net)|20.0|||<|0.012||95.0|6.7|33.3|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735511|NCT00491764|3195623|Superiority or Other||Mean Difference (Net)|45.5|||<|0.001||95.0|28.5|62.4|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735512|NCT00491764|3195623|Superiority or Other||Mean Difference (Net)|54.1|||<|0.001||95.0|38.0|70.1|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735513|NCT00491764|3195623|Superiority or Other||Mean Difference (Net)|22.9|||<|0.005||95.0|8.9|36.8|||Fisher Exact||Difference is in the proportion for Yes responders. Confidence Interval is around the difference in proportions.||
1735514|NCT00491556|3195633|Superiority or Other||Mean Difference (Final Values)|-1.31|Standard Deviation|2.54||0.0215|2-Sided|95.0|-2.41|-0.21|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735515|NCT00491556|3195634|Superiority or Other||Mean Difference (Final Values)|3.69|Standard Deviation|2.97|<|0.0001|2-Sided|95.0|2.4|4.97|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735516|NCT00491556|3195635|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Deviation|14.12||0.9198|2-Sided|95.0|-6.41|5.81|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735517|NCT00491556|3195636|Superiority or Other||Mean Difference (Final Values)|11.7|Standard Deviation|13.83||0.0005|2-Sided|95.0|5.72|17.69|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735518|NCT00491556|3195637|Superiority or Other||Mean Difference (Final Values)|-1.95|Standard Deviation|5.12||0.0808|2-Sided|95.0|-4.17|0.26|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735519|NCT00491556|3195638|Superiority or Other||Mean Difference (Final Values)|12.47|Standard Deviation|6.81|<|0.0001|2-Sided|95.0|9.52|15.41|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735520|NCT00491556|3195639|Superiority or Other||Mean Difference (Final Values)|4.23|Standard Deviation|15.37||0.1999|2-Sided|95.0|-2.41|10.88|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735521|NCT00491556|3195640|Superiority or Other||Mean Difference (Final Values)|-22.65|Standard Deviation|12.93|<|0.0001|2-Sided|95.0|-28.24|-17.06|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735522|NCT00491556|3195641|Superiority or Other||Mean Difference (Final Values)|-3.21|Standard Deviation|5.88||0.0157|2-Sided|95.0|-5.75|-0.67|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735523|NCT00491556|3195642|Superiority or Other||Mean Difference (Final Values)|11.52|Standard Deviation|5.59|<|0.0001|2-Sided|95.0|9.1|13.94|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735524|NCT00491556|3195643|Superiority or Other||Mean Difference (Final Values)|1.87|Standard Deviation|8.13||0.2831|2-Sided|95.0|-1.65|5.38|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735525|NCT00491556|3195644|Superiority or Other||Mean Difference (Final Values)|-2.53|Standard Deviation|8.94||0.1886|2-Sided|95.0|-6.4|1.34|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735526|NCT00491556|3195645|Superiority or Other||Mean Difference (Final Values)|-2.03|Standard Error of the Mean|5.55||0.0929|2-Sided|95.0|-4.43|0.37|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735527|NCT00491556|3195646|Superiority or Other||Mean Difference (Final Values)|19.69|Standard Deviation|8.7|<|0.0001|2-Sided|95.0|15.93|23.45|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735528|NCT00491556|3195647|Superiority or Other||Mean Difference (Final Values)|-3.45|Standard Deviation|13.6||0.2363|2-Sided|95.0|-9.33|2.43|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735529|NCT00491556|3195648|Superiority or Other||Mean Difference (Final Values)|-19.35|Standard Deviation|10.26|<|0.0001|2-Sided|95.0|-23.79|-14.91|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735530|NCT00491556|3195649|Superiority or Other||Mean Difference (Final Values)|-3.14|Standard Deviation|6.2||0.0239|2-Sided|95.0|-5.81|-0.46|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735531|NCT00491556|3195650|Superiority or Other||Mean Difference (Final Values)|14.6|Standard Deviation|6.03|<|0.0001|2-Sided|95.0|11.99|17.21|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735532|NCT00491556|3195651|Superiority or Other||Mean Difference (Final Values)|-2.2|Standard Deviation|12.39||0.4029|2-Sided|95.0|-7.56|3.16|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735533|NCT00491556|3195652|Superiority or Other||Mean Difference (Final Values)|4.97|Standard Deviation|11.04||0.042|2-Sided|95.0|0.2|9.74|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735534|NCT00491556|3195653|Superiority or Other||Mean Difference (Final Values)|-2.2|Standard Deviation|7.25||0.1592|2-Sided|95.0|-5.34|0.93|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735535|NCT00491556|3195654|Superiority or Other||Mean Difference (Final Values)|21.98|Standard Deviation|8.48|<|0.0001|2-Sided|95.0|18.31|25.65|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735536|NCT00491556|3195655|Superiority or Other||Mean Difference (Final Values)|1.95|Standard Deviation|16.96||0.5864|2-Sided|95.0|-5.38|9.28|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735537|NCT00491556|3195656|Superiority or Other||Mean Difference (Final Values)|-23.52|Standard Deviation|13.79|<|0.0001|2-Sided|95.0|-29.48|-17.55|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735538|NCT00491556|3195657|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Deviation|1.49||0.915|2-Sided|95.0|-0.61|0.68|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735539|NCT00491556|3195658|Superiority or Other||Mean Difference (Final Values)|1.95|Standard Deviation|2.07||0.0002|2-Sided|95.0|1.05|2.84|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735540|NCT00491556|3195659|Superiority or Other||Mean Difference (Final Values)|3.93|Standard Deviation|10.95||0.0995|2-Sided|95.0|-0.81|8.66|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735541|NCT00491556|3195660|Superiority or Other||Mean Difference (Final Values)|12.58|Standard Deviation|10.24||0.0001|2-Sided|95.0|8.15|17.01|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735542|NCT00491556|3195661|Superiority or Other||Mean Difference (Final Values)|-2.87|Standard Deviation|6.93||0.0594|2-Sided|95.0|-5.87|0.12|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735543|NCT00491556|3195662|Superiority or Other||Mean Difference (Final Values)|11.24|Standard Deviation|7.82|<|0.0001|2-Sided|95.0|7.85|14.62|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735544|NCT00491556|3195663|Superiority or Other||Mean Difference (Final Values)|1.66|Standard Deviation|14.2||0.5815|2-Sided|95.0|-4.48|7.8|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735545|NCT00491556|3195664|Superiority or Other||Mean Difference (Final Values)|-18.07|Standard Deviation|13.2|<|0.0001|2-Sided|95.0|-23.78|-12.36|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735546|NCT00491556|3195665|Superiority or Other||Mean Difference (Final Values)|86.98|Standard Deviation|139.33||0.0067|2-Sided|95.0|26.73|147.23|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735547|NCT00491556|3195666|Superiority or Other||Mean Difference (Final Values)|-39.37|Standard Deviation|145.62||0.2082|2-Sided|95.0|-102.34|23.6|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Week 48 and Week 152.|
1735548|NCT00491556|3195667|Superiority or Other||Mean Difference (Final Values)|33.49|Standard Deviation|64.41||0.0207|2-Sided|95.0|5.64|61.34|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735549|NCT00491556|3195668|Superiority or Other||Mean Difference (Final Values)|90.82|Standard Deviation|107.8||0.0005|2-Sided|95.0|44.2|137.43|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735550|NCT00491556|3195669|Superiority or Other||Mean Difference (Final Values)|-20.4|Standard Deviation|58.18||0.1067|2-Sided|95.0|-45.56|4.76|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735551|NCT00491556|3195670|Superiority or Other||Mean Difference (Final Values)|79.81|Standard Deviation|76.07|<|0.0001|2-Sided|95.0|46.92|112.71|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735552|NCT00491556|3195671|Superiority or Other||Mean Difference (Final Values)|-91.86|Standard Deviation|166.4||0.0147|2-Sided|95.0|-163.82|-19.9|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735553|NCT00491556|3195672|Superiority or Other||Mean Difference (Final Values)|40.46|Standard Deviation|213.77||0.3739|2-Sided|95.0|-51.98|132.9|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735554|NCT00491556|3195673|Superiority or Other||Mean Difference (Final Values)|87.64|Standard Deviation|97.71||0.0003|2-Sided|95.0|45.39|129.9|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152.|Null hypothesis is no changes between Week 48 and Week 152.|
1735555|NCT00491556|3195674|Superiority or Other||Mean Difference (Final Values)|-126.79|Standard Deviation|105.61|<|0.0001|2-Sided|95.0|-172.46|-81.12|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48.|Null hypothesis is no changes between Baseline and Week 48.|
1735556|NCT00491556|3195675|Superiority or Other||Mean Difference (Final Values)|16.87|Standard Deviation|68.75||0.2519|2-Sided|95.0|-12.86|46.6|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152|
1735557|NCT00491556|3195676|Superiority or Other||Mean Difference (Final Values)|-76.92|Standard Deviation|56.31|<|0.0001|2-Sided|95.0|-101.27|-52.57|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Week 48 and Week 152|
1735558|NCT00491556|3195677|Superiority or Other||Mean Difference (Final Values)|-43.08|Standard Deviation|75.17||0.0117|2-Sided|95.0|-75.59|-10.58|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152|
1735559|NCT00491556|3195678|Superiority or Other||Mean Difference (Final Values)|-17.13|Standard Deviation|56.72||0.1616|2-Sided|95.0|-41.66|7.4|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.|
1735560|NCT00491556|3195679|Superiority or Other||Mean Difference (Final Values)|-103.53|Standard Deviation|176.61||0.0102|2-Sided|95.0|-179.9|-27.16|||t-test, 2 sided|||Null hypothesis is no changes between Week 48 and Week 152|
1735561|NCT00491556|3195680|Superiority or Other||Mean Difference (Final Values)|-58.79|Standard Deviation|152.57||0.0781|2-Sided|95.0|-124.77|7.18|||t-test, 2 sided|||Null hypothesis is no changes between Baseline and Week 48.|
1735562|NCT00491556|3195681|Superiority or Other||Mean Difference (Final Values)|-24.2|Standard Deviation|242.38||0.6222|2-Sided|95.0|-124.25|75.85|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152|
1735563|NCT00491556|3195682|Superiority or Other||Mean Difference (Final Values)|-317.36|Standard Deviation|176.07|<|0.0001|2-Sided|95.0|-390.04|-244.68|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.|
1735564|NCT00491556|3195683|Superiority or Other||Mean Difference (Final Values)|-1.81|Standard Deviation|5.0||0.0834|2-Sided|95.0|-3.87|0.26|||t-test, 2 sided||Difference was calculated as Week 48 minus Week 152|Null hypothesis is no changes between Week 48 and Week 152|
1735565|NCT00491556|3195684|Superiority or Other||Mean Difference (Final Values)|-10.08|Standard Deviation|5.13|<|0.0001|2-Sided|95.0|-12.2|-7.97|||t-test, 2 sided||Difference was calculated as Baseline minus Week 48|Null hypothesis is no changes between Baseline and Week 48.|
1735566|NCT00491504|3195692|Superiority or Other|||||||0.625|||||||ANCOVA|An analysis of covariance (ANCOVA) model was used with treatment as effect and Baseline as a covariate.|||
1735567|NCT00491322|3195697|Superiority or Other||||||<|0.05|||||||ANOVA||||
1735568|NCT00491244|3195698|Superiority or Other||Risk Ratio (RR)|1.61||||0.35|2-Sided|95.0|0.65|4.01|||Chi-squared||||
1735569|NCT00491244|3195699|Superiority or Other||Risk Ratio (RR)|1.8|||<|0.001|2-Sided|95.0|1.46|2.21|||Chi-squared||||
1735570|NCT00490971|3195703|Superiority or Other|||||||0.007|||||||ANCOVA|ANCOVA Model on ranks with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)|
1735571|NCT00490971|3195704|Superiority or Other||Mean Difference (Final Values)|5.7||||0.01|2-Sided|95.0|1.4|10.09|||ANCOVA|ANCOVA Model with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)|
1735572|NCT00490971|3195705|Superiority or Other||Mean Difference (Final Values)|0.3||||0.763|2-Sided|95.0|-1.87|2.55|||ANCOVA|ANCOVA Model with treatment (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)|
1735573|NCT00490971|3195706|Superiority or Other||Mean Difference (Final Values)|-4.5|||<|0.001|2-Sided|95.0|-6.92|-1.98|||ANCOVA|ANCOVA model with treatment group (Pali/Pali, Pali/Placebo) and country as factors with baseline value as covariate||Change from Baseline (Maintenance Phase) to Endpoint (Maintenance Phase)|
1735574|NCT00490971|3195707|Superiority or Other||Hazard Ratio (HR)|0.88|||||2-Sided|95.0|0.53|1.46|||||Hazard ratio was estimated with Pali/Placebo in the numerator and Pali/Pali in the denominator||
1735575|NCT00490971|3195708|Superiority or Other||||||<|0.001||||||The two treatment groups were compared using a weighted z-statistic based on rho-family of alpha spending function at information fraction of 81.9% at interim analysis analysis (rho=2.5) at 0.025 (1-sided) level. One-sided alpha at final was 0.0198.|Weighted z-test|||At the time of interim analysis of the primary efficacy endpoint, the proportion of recurrence of manic symptoms was 81.9% of the number of recurrence of manic symptoms at final analysis. A flexible group-sequential approach was adopted. The general family of alpha spending function based on the rho-family with rho=2.5 at overall type I error of 0.025 (1-sided) was employed.|
1735576|NCT00490971|3195709|Superiority or Other|||||||0.017||||||The two treatment groups were compared using a weighted z-statistic based on rho-family of alpha spending function at information fraction of 85.0% at interim analysis analysis (rho=2.5) at 0.025 (1-sided) level. One-sided alpha at final was 0.0195.|Weighted Z- test|||Null hypothesis: there is no difference between Pali/Pali and Pali/Placebo in the time to recurrence of any mood symptoms related to bipolar I disorder. An interim analysis was performed when approximately 85% of the required number of recurrences were reported in Pali/Pali and Pali/Placebo treatment groups. A flexible group-sequential approach was adopted. The general family of alpha spending function based on the rho-family with rho=2.5 at overall type I error of 0.025 (1-sided) was employed.|
1735577|NCT00490919|3195716|Superiority or Other||Mean Difference (Final Values)|-4.4|Standard Error of the Mean|1.605||0.0062|2-Sided|95.0|-7.55|-1.25||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holms methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|Mixed effects general linear model with repeated measures.|Treatment comparison over Weeks 4, 8, and 12.|The primary comparison between groups was based on estimates and contrasts for the weeks 4, 8, and 12 mean values.|
1735578|NCT00490919|3195717|Superiority or Other||Mean Difference (Final Values)|-0.124|Standard Error of the Mean|0.0874||0.1586|2-Sided|95.0|-0.296|0.048||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holms methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||Mean comparison from weeks 2-12 of the double-blind phase.||
1735579|NCT00490919|3195718|Superiority or Other||Mean Difference (Final Values)|-0.58|Standard Error of the Mean|0.225||0.0104|2-Sided|95.0|-1.02|-0.14|||Mixed Models Analysis|Mixed effects general linear model with repeated measures.|Double-blind analysis (comparison between BTDS and placebo TDS) at week 12 of the double-blind phase.|Missing average pain over the last 24 hours scores after treatment discontinuation were imputed using BOCF for adverse event-related withdrawals and LOCF for withdrawals due to other reasons.|
1735622|NCT00489255|3196009|Superiority or Other||Mean Difference (Net)|1.47||||0.46|2-Sided|95.0|-2.47|5.4|||ANOVA||||
1735623|NCT00489255|3196010|Superiority or Other||Mean Difference (Net)|2.97||||0.25|2-Sided|95.0|-2.17|8.11|||ANOVA||||
1735624|NCT00489255|3196011|Superiority or Other||Mean Difference (Net)|0.39||||0.84|2-Sided|95.0|-4.12|3.34|||ANOVA||||
1735580|NCT00490841|3195735|Superiority or Other||||||<|0.0001|||||||1-sided exact binomial test|||"objective is to demonstrate the binary restenosis rate at 9 months is < 28.6% OPC. Assumptions for the primary endpoint analysis:~H0: Restenosis Rate ≥ 28.6%~HA: Restenosis Rate < 28.6%~Assumed binary restenosis rate = 20%~Power = 80%~One-sided type I error = 5%~With the above assumptions, 161 samples would be required. To account for approximately 20% lost to follow–up rate, 202 subjects will be enrolled in the study. The sample size calculation was performed using PASS 2005."|
1735581|NCT00490542|3195794|Superiority or Other||Mean Difference (Final Values)|5.4|||||2-Sided|95.0|0.6|10.2|||||||
1735582|NCT00490139|3195822|Superiority or Other (legacy)||Hazard Ratio (HR)|1.34|||<|0.0005||97.5|1.13|1.6|||Stratified log-rank test|Stratification is by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap versus tras) is based on the Cox’s proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and auxillary lymph node status.||
1735583|NCT00490139|3195822|Superiority or Other (legacy)||Hazard Ratio (HR)|0.96|||<|0.61||97.5|0.8|1.15|||Stratified log-rank test|Stratification is by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (tras followed by lap versus tras) is based on the Cox’s proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and auxillary lymph node status.||
1735584|NCT00490139|3195822|Superiority or Other (legacy)||Hazard Ratio (HR)|0.84|||<|0.048||97.5|0.7|1.02|||Stratified log-rank test|Stratification was by chemotherapy timing, hormone receptor status, and axillary lymph node status.|The estimate of the treatment hazard ratio (lap plus tras versus tras) is based on the Cox’s proportional hazards model adjusting for the stratification factors of chemotherapy timing, hormone receptor status, and auxillary lymph node status.||
1735585|NCT00490035|3195849|Superiority or Other||Percentage Reduction over Placebo|6.5|||=|0|2-Sided|95.0|-5.2|16.9|||ANCOVA|||In order to control the Type I error testing was performed in sequence starting with 50 mg, then 100 mg and finally 20 mg Brivaracetam per day versus Placebo, only moving to the next test if the previous one was significant at the 5 % level.|
1735586|NCT00489970|3195879|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response|-4.76|||||2-Sided|97.5|-14.53|3.18|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.|
1735587|NCT00489970|3195879|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|4.01|||||2-Sided|97.5|-2.38|8.66|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.|
1735588|NCT00489970|3195879|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-1.24|||||2-Sided|97.5|-10.03|5.57|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.|
1735589|NCT00489970|3195879|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against PRN antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-10.32|||||2-Sided|97.5|-17.5|-3.38|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PRN antigen, one month following vaccination.|
1735590|NCT00489970|3195879|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against FHA antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-7.05|||||2-Sided|97.5|-13.16|-1.4|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against FHA antigen, one month following vaccination.|
1735591|NCT00489970|3195879|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against PT antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-2.85|||||2-Sided|97.5|-9.09|3.08|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against PT antigen, one month following vaccination.|
1735625|NCT00489255|3196012|Superiority or Other||Mean Difference (Net)|-0.18||||0.93|2-Sided|95.0|-4.37|4.02|||ANOVA||||
1735592|NCT00489970|3195880|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-11.79|||||2-Sided|97.5|-22.98|0.15|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.|
1735593|NCT00489970|3195880|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-8.56|||||2-Sided|97.5|-20.33|2.73|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.|
1735594|NCT00489970|3195880|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-1.44|||||2-Sided|97.5|-10.63|7.79|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against tetanus antigen, one month following vaccination.|
1735595|NCT00489970|3195880|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the booster response rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in booster response rate|-5.91|||||2-Sided|97.5|-14.67|2.85|||||Standardized asymptotic 97.5% CI for the group difference in the Booster response was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to booster response against diphtheria antigen, one month following vaccination.|
1735596|NCT00489970|3195881|Non-Inferiority|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|4.47|||||2-Sided|97.5|3.58|5.57||||||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination|
1735597|NCT00489970|3195881|Non-Inferiority|One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|5.27|||||2-Sided|97.5|4.37|6.36||||||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination|
1735598|NCT00489970|3195881|Non-Inferiority or Equivalence (legacy)|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Adacel Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|1.64||||||97.5|1.33|2.03||||||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Adacel Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination|
1735599|NCT00489970|3195881|Non-Inferiority|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PRN GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|3.62|||||2-Sided|97.5|3.07|4.25||||||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PRN one month following vaccination|
1735600|NCT00489970|3195881|Non-Inferiority|One month after vaccination, the lower limits of the 97.5% CIs for the anti-FHA GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|5.27|||||2-Sided|97.5|4.62|6.01||||||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-FHA one month following vaccination|
1735601|NCT00489970|3195881|Non-Inferiority|One month after vaccination, the lower limits of the 97.5% CIs for the anti-PT GMC ratios (Boostrix Group divided by Infanrix Group in APV-039) were greater than or equal to 0.67|GMC ratio|1.53|||||2-Sided|97.5|1.31|1.79||||||To demonstrate that the immune response elicited by a second dose of Tdap vaccine, Boostrix (Boostrix Group) was non-inferior to the immune response elicited by a three dose series of Infanrix vaccine in infants in the German household contact efficacy study APV-039, with respect to antibodies against anti-PT one month following vaccination|
1735626|NCT00489255|3196013|Superiority or Other||Mean Difference (Net)|0.08||||0.96|2-Sided|95.0|-3.59|3.76|||ANOVA|ANCOVA model with baseline score (score at Visit 1/Screening) as a covariate, and site and treatment as factors.|||
1735627|NCT00489255|3196014|Superiority or Other||Hazard Ratio (HR)|1.2||||0.62||95.0|0.6|2.3||Cox’s proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox||||
1735628|NCT00489255|3196015|Superiority or Other||Hazard Ratio (HR)|1.2||||0.4|2-Sided|95.0|0.7|2.1|||Regression, Cox||||
1735602|NCT00489970|3195883|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|0.31|||||2-Sided|97.5|-3.69|2.07|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.|
1735603|NCT00489970|3195883|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% CI for the difference between groups in the seroprotection rate [a second dose of Boostrix (Adacel group) minus the first dose of Boostrix (Control group)] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|1.32|||||2-Sided|97.5|-3.41|4.15|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Adacel group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.|
1735604|NCT00489970|3195883|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against tetanus antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|0.31|||||2-Sided|97.5|-1.52|2.07|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against tetanus antigen, one month following vaccination.|
1735605|NCT00489970|3195883|Non-Inferiority|One month after vaccination, the lower limit of the 97.5% confidence interval (CI) for the difference between groups in the seroprotection rate [a second dose of Boostrix (Boostrix group) minus the first dose of Boostrix (Control group)] against diphtheria antigen was greater than or equal to -10% (clinical limit for non-inferiority).|Difference in percentage|1.41|||||2-Sided|97.5|-1.16|4.17|||||Standardized asymptotic 97.5% CI for the group difference in the seroprotection rate was calculated.|To demonstrate that the immune response elicited by a second dose of Boostrix vaccine (Boostrix group and Control group) was non-inferior to the immune response elicited by a first dose of Boostrix vaccine (Control group), with respect to seroprotection rate against diphtheria antigen, one month following vaccination.|
1735606|NCT00489736|3195942|Superiority or Other||Hazard Ratio (HR)|0.61||||0.002||95.0|0.44|0.84||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of MSE occurrence excluding gastrointestinal events, for the dronedarone group compared with the amiodarone group.||
1735607|NCT00489736|3195943|Superiority or Other||Hazard Ratio (HR)|0.8||||0.13||95.0|0.6|1.07||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of main safety event occurrence for the dronedarone group compared with the amiodarone group.||
1735608|NCT00489736|3195944|Superiority or Other||Hazard Ratio (HR)|1.59|||<|0.0001||95.0|1.28|1.98||Cumulative incidence functions in each treatment group were calculated using time-to-event non-parametric Kaplan-Meier estimate. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It provides the relative hazard of treatment failure for the dronedarone group compared with the amiodarone group.||
1735609|NCT00489541|3195960|Superiority or Other||12-month TLR rate|7.34|||<|0.0001|1-Sided|95.0||10.8|||Chi-squared|||One-sided, single-sample binomial test to compare the observed TLF rate in PERSEUS SV to the pre-specified performance goal (19.5%). The normal approximation of the test statistic was used. The null hypothesis that the true TAXUS Element TLF rate is greater than or equal to the performance goal was tested against the one-sided alternative that the true rate is less than the performance goal. A sample size of 224 patients (accounting for 5% attrition to follow-up) provided 80% power.|
1735610|NCT00489541|3195961|Superiority or Other||Mean Difference (Final Values)|-0.42|||<|0.0001|2-Sided|95.0|-0.54|-0.3|||t-test, 2 sided|||A superiority test of TAXUX Element vs bare metal (BMS) Express historical control. The null hypothesis that the true difference in means (TAXUS Element – BMS Express) is equal to zero was tested against the two-sided alternative that the true difference in means is different from zero. A sample size of 224 patients in the TAXUS Element group (190 after 15% attrition due to angiographic follow-up) provided 85% power.|
1735611|NCT00489476|3195970|Superiority|||||||0.0409|||||||Fisher Exact||||
1735612|NCT00489476|3195971|Superiority|||||||0.0228|||||||Fisher Exact||||
1735613|NCT00489476|3195971|Superiority|||||||0.0123|||||||Fisher Exact||||
1735614|NCT00489476|3195972|Superiority|||||||0.0106|||||||Fisher Exact||||
1735615|NCT00489476|3195972|Superiority|||||||0.0212|||||||Fisher Exact||||
1735616|NCT00489411|3195981|Superiority or Other||Mean difference|1.01|||||2-Sided|95.0|0.36|1.65|||||||
1735617|NCT00489411|3195982|Superiority or Other||Mean Difference|1.58||||0.03|2-Sided|95.0|0.15|3.0|||Wilcoxon (Mann-Whitney)||||
1735618|NCT00489411|3195983|Superiority or Other||Mean Difference|4.4|||||2-Sided|95.0|0.93|7.88|||||||
1735619|NCT00489411|3195984|Superiority or Other||Mean Difference|0.73||||0.003|2-Sided|95.0|0.26|1.2|||Wilcoxon (Mann-Whitney)||||
1735620|NCT00489255|3196007|Superiority or Other||Mean Difference (Net)|0.27||||0.93|2-Sided|95.0|-5.57|6.11|||ANOVA||||
1735621|NCT00489255|3196008|Superiority or Other||Mean Difference (Net)|2.96||||0.33|2-Sided|95.0|-3.13|9.06|||ANOVA||||
1735629|NCT00489255|3196016|Superiority or Other||Hazard Ratio (HR)|0.9||||0.49|2-Sided|95.0|0.6|1.3||Cox’s proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox||||
1735630|NCT00489255|3196017|Superiority or Other||Hazard Ratio (HR)|0.3||||0.008|2-Sided|95.0|0.1|0.7||Cox’s proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox||||
1735631|NCT00489255|3196018|Superiority or Other||Hazard Ratio (HR)|0.7||||0.17|2-Sided|95.0|0.5|1.1||Cox’s proportional hazards model with site and treatment (Tigan/placebo) as factors.|Regression, Cox||||
1735632|NCT00489255|3196019|Superiority or Other|||||||0.29|||||||Cochran-Mantel-Haenszel||||
1735633|NCT00489255|3196020|Superiority or Other|||||||0.019|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (row mean score) with rigid scores, stratified by site|||
1735634|NCT00489255|3196021|Superiority or Other|||||||0.88|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test (row mean score) with rigid scores, stratified by site|||
1735635|NCT00489255|3196022|Superiority or Other||Median Difference (Net)|-0.01||||0.95|2-Sided|95.0|-0.2|0.19|||ANOVA||||
1735636|NCT00489255|3196023|Superiority or Other||Median Difference (Net)|-1.07||||0.001|2-Sided|95.0|-1.71|-0.43|||ANOVA||||
1735637|NCT00489255|3196024|Superiority or Other||Median Difference (Net)|-0.21||||0.32|2-Sided|95.0|-0.64|0.21|||ANOVA|Treatment effect in ANOVA was adjusted for site.|||
1735638|NCT00489255|3196025|Superiority or Other||Odds Ratio (OR)|0.75||||0.65|2-Sided|95.0|0.23|2.48|||Cochran-Mantel-Haenszel||||
1735639|NCT00489255|3196026|Superiority or Other||Odds Ratio (OR)|0.25||||0.005|2-Sided|95.0|0.09|0.7|||Cochran-Mantel-Haenszel||||
1735640|NCT00489255|3196027|Superiority or Other||Odds Ratio (OR)|0.44||||0.025|2-Sided|95.0|0.21|0.9|||Cochran-Mantel-Haenszel||||
1735641|NCT00489255|3196028|Superiority or Other||Odds Ratio (OR)|0.43||||0.09|2-Sided|95.0|0.17|1.11|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test for treatment was stratified by site.||The null hypothesis was no difference between treatments.|
1735642|NCT00488826|3196047|Superiority or Other||Geometric mean ratio|44.7||||||90.0|29.48|68.71|||||This analysis is for Serotype 23F.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735643|NCT00488826|3196047|Superiority or Other||Geometric mean ratio|81.45||||||90.0|57.98|119.1|||||This analysis is for Serotype 19F.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735644|NCT00488826|3196047|Superiority or Other||Geometric mean ratio|164.0||||||90.0|114.9|232.9|||||This analysis is for Serotype 18C.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735645|NCT00488826|3196047|Superiority or Other||Geometric mean ratio|99.48||||||90.0|61.09|147.5|||||This analysis is for Serotype 14.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735646|NCT00488826|3196047|Superiority or Other||Geometric mean ratio|73.7||||||90.0|56.41|103.6|||||This analysis is for Serotype 9V.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735647|NCT00488826|3196047|Superiority or Other||Geometric mean ratio|22.2||||||90.0|13.99|31.77|||||This analysis is for Serotype 6B.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735648|NCT00488826|3196047|Superiority or Other||Geometric mean ratio|665.1||||||90.0|473.3|851.2|||||This analysis is for Serotype 4.|"The ratio of the 7vPnC + DTaP Concurrently group to DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735649|NCT00488826|3196048|Superiority or Other||Geometric mean ratio|90.02||||||90.0|57.93|150.5|||||This analysis is for Serotype 23F.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735650|NCT00488826|3196048|Superiority or Other||Geometric mean ratio|181.3||||||90.0|119.8|253.1|||||This analysis is for Serotype 19F.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735651|NCT00488826|3196048|Superiority or Other||Geometric mean ratio|200.3||||||90.0|151.9|302.4|||||This analysis is for Serotype 18C.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735652|NCT00488826|3196048|Superiority or Other||Geometric mean ratio|134.3||||||90.0|80.83|197.1|||||This analysis is for Serotype 14.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735653|NCT00488826|3196048|Superiority or Other||Geometric mean ratio|99.48||||||90.0|79.81|142.0|||||This analysis is for Serotype 9V|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735654|NCT00488826|3196048|Superiority or Other||Geometric mean ratio|54.6||||||90.0|35.36|85.49|||||This analysis is for Serotype 6B.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735655|NCT00488826|3196048|Superiority or Other||Geometric mean ratio|1097.0||||||90.0|793.6|1461.0|||||This analysis is for Serotype 4.|"The ratio of the 7vPnC Separately group to the DTaP Alone group geometric mean comparisons (GMC) was provided with a corresponding 90% confidence interval."|
1735656|NCT00488774|3196049|Superiority or Other|||||||0.702|||||||Chi-squared||||
1735657|NCT00488774|3196049|Superiority or Other|||||||0.37|||||||Chi-squared||||
1735658|NCT00488774|3196049|Superiority or Other|||||||0.832|||||||Chi-squared||||
1735659|NCT00488774|3196050|Superiority or Other|||||||0.145|||||||Chi-squared||||
1735660|NCT00488774|3196050|Superiority or Other|||||||0.081|||||||Chi-squared||||
1735661|NCT00488774|3196050|Superiority or Other|||||||0.467|||||||Chi-squared||||
1738474|NCT00457197|3200383|Superiority or Other|||||||0.1412|||||||ANCOVA|||Baseline ALT used as covariate.|
1735662|NCT00488683|3196057|Superiority or Other||R-square|0.07||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y|
1735663|NCT00488683|3196057|Superiority or Other||R-square|0.37||||||95.0||||||||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y|
1735664|NCT00488683|3196057|Superiority or Other||R-square|0.17||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135|
1735665|NCT00488683|3196057|Superiority or Other||R-square|0.45||||0.0436||95.0|||||Regression, Linear|||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135|
1735666|NCT00488683|3196057|Superiority or Other||R-square|0.08||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C|
1735667|NCT00488683|3196057|Superiority or Other||R-square|0.08||||||95.0||||||||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C|
1735668|NCT00488683|3196057|Superiority or Other||R-square|0.19||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A|
1735669|NCT00488683|3196057|Superiority or Other||R-square|0.27||||||95.0||||||||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A|
1735670|NCT00488683|3196057|Superiority or Other||R-square|0.0||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y|
1735671|NCT00488683|3196057|Superiority or Other||R-square|0.01||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup Y|
1735672|NCT00488683|3196057|Superiority or Other||R-square|0.0018||||||95.0|||||||Values from Groups 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135|
1735673|NCT00488683|3196057|Superiority or Other||R-square|0.0048||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup W-135|
1735674|NCT00488683|3196057|Superiority or Other||R-square|0.02||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C|
1735675|NCT00488683|3196057|Superiority or Other||R-square|0.01||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup C|
1735676|NCT00488683|3196057|Superiority or Other||R-square|0.0057||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A|
1735677|NCT00488683|3196057|Superiority or Other||R-square|0.0015||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and rise in serogroup specific IgG concentration after booster vaccination age for the serogroup A|
1735678|NCT00488683|3196057|Superiority or Other||R-square|0.12||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y|
1735679|NCT00488683|3196057|Superiority or Other||R-square|0.21||||||95.0||||||||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y|
1735680|NCT00488683|3196057|Superiority or Other||R-square|0.3||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135|
1735681|NCT00488683|3196057|Superiority or Other||R-square|1.0||||||95.0||||||||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135|
1735682|NCT00488683|3196057|Superiority or Other||R-square|0.16||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C|
1735683|NCT00488683|3196057|Superiority or Other||R-square|0.5||||||95.0||||||||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C|
1735684|NCT00488683|3196057|Superiority or Other||R-square|0.21||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A|
1735685|NCT00488683|3196057|Superiority or Other||R-square|0.7||||||95.0||||||||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A|
1735686|NCT00488683|3196057|Superiority or Other||R-square|0.05||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y|
1735687|NCT00488683|3196057|Superiority or Other||R-square|0.19||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup Y|
1735688|NCT00488683|3196057|Superiority or Other||R-square|0.29||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135|
1735689|NCT00488683|3196057|Superiority or Other||R-square|1.0||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup W-135|
1735690|NCT00488683|3196057|Superiority or Other||R-square|0.07||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C|
1735691|NCT00488683|3196057|Superiority or Other||R-square|0.52||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup C|
1735692|NCT00488683|3196057|Superiority or Other||R-square|0.19||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A|
1735693|NCT00488683|3196057|Superiority or Other||R-square|0.24||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and rise in hSBA after booster vaccination age for the serogroup A|
1735694|NCT00488683|3196058|Superiority or Other||R-square|0.33||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y|
1735695|NCT00488683|3196058|Superiority or Other||R-square|0.39||||||95.0||||||||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y|
1735696|NCT00488683|3196058|Superiority or Other||R-square|0.21||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135|
1735697|NCT00488683|3196058|Superiority or Other||R-square|0.17||||||95.0||||||||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135|
1735698|NCT00488683|3196058|Superiority or Other||R-square|0.06||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C|
1735699|NCT00488683|3196058|Superiority or Other||R-square|0.11||||||95.0||||||||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C|
1735700|NCT00488683|3196058|Superiority or Other||R-square|0.1||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A|
1735701|NCT00488683|3196058|Superiority or Other||R-square|0.3||||||95.0||||||||Linear regression coefficient between demographic factors memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A|
1735702|NCT00488683|3196058|Superiority or Other||R-square|0.28||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y|
1735703|NCT00488683|3196058|Superiority or Other||R-square|0.13||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup Y|
1735704|NCT00488683|3196058|Superiority or Other||R-square|0.08||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135|
1735705|NCT00488683|3196058|Superiority or Other||R-square|0.02||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup W-135|
1735706|NCT00488683|3196058|Superiority or Other||R-square|0.04||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C|
1735707|NCT00488683|3196058|Superiority or Other||R-square|0.007||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup C|
1735708|NCT00488683|3196058|Superiority or Other||R-square|0.02||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A|
1735709|NCT00488683|3196058|Superiority or Other||R-square|0.03||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at 12 months of age for the serogroup A|
1735710|NCT00488683|3196058|Superiority or Other||R-square|0.85||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y|
1735711|NCT00488683|3196058|Superiority or Other||R-square|0.94||||||95.0||||||||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y|
1735712|NCT00488683|3196058|Superiority or Other||R-square|0.78||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135|
1735713|NCT00488683|3196058|Superiority or Other||R-square|0.9||||||95.0||||||||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135|
1735714|NCT00488683|3196058|Superiority or Other||R-square|0.17||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C|
1735715|NCT00488683|3196058|Superiority or Other||R-square|0.13||||||95.0||||||||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C|
1735716|NCT00488683|3196058|Superiority or Other||R-square|0.14||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A|
1735717|NCT00488683|3196058|Superiority or Other||R-square|0.37||||||95.0||||||||Linear regression coefficient between demographic factors, memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A|
1735718|NCT00488683|3196058|Superiority or Other||R-square|0.53||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y|
1735719|NCT00488683|3196058|Superiority or Other||R-square|0.74||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup Y|
1735720|NCT00488683|3196058|Superiority or Other||R-square|0.33||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135|
1735721|NCT00488683|3196058|Superiority or Other||R-square|0.22||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup W-135|
1735722|NCT00488683|3196058|Superiority or Other||R-square|0.16||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup C|
1735723|NCT00488683|3196058|Superiority or Other||R-square|0.09||||||95.0||||||||Linear regression coefficient between demographic factors, memory B cells at 5 months of age and hSBA titers at 12 months of age after a 2, 4-month course of MenACWY-CRM vaccination for the serogroup C|
1735724|NCT00488683|3196058|Superiority or Other||R-square|0.14||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A|
1735725|NCT00488683|3196058|Superiority or Other||R-square|0.34||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers at 12 months of age for the serogroup A|
1735726|NCT00488683|3196059|Superiority or Other||R-square|0.0009||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y|
1735727|NCT00488683|3196059|Superiority or Other||R-square|0.0008||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135|
1735728|NCT00488683|3196059|Superiority or Other||R-square|0.0014||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C|
1735729|NCT00488683|3196059|Superiority or Other||R-square|0.0013||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A|
1735730|NCT00488683|3196059|Superiority or Other||Spearman correlation coefficient|0.02||||0.82||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y|
1735731|NCT00488683|3196059|Superiority or Other||Spearman correlation coefficient|-0.11||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135|
1735732|NCT00488683|3196059|Superiority or Other||Spearman correlation coefficient|-0.07||||0.36||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C|
1735733|NCT00488683|3196059|Superiority or Other||Spearman correlation coefficient|0.18||||0.05||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A|
1735734|NCT00488683|3196059|Superiority or Other||Pearson correlation coefficient|-0.03||||0.74||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup Y|
1735735|NCT00488683|3196059|Superiority or Other||Pearson correlation coefficient|-0.03||||0.74||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup W-135|
1735736|NCT00488683|3196059|Superiority or Other||Pearson correlation coefficient|-0.04||||0.63||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup C|
1736134|NCT00487240|3196331|Superiority or Other|||||||0.82||||||P-value for Total Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country|||
1735737|NCT00488683|3196059|Superiority or Other||Pearson correlation coefficient|0.04||||0.7||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration at day 1 in the serum of mother for the serogroup A|
1735738|NCT00488683|3196065|Superiority or Other||R-square|0.25||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination|
1735739|NCT00488683|3196065|Superiority or Other||R-square|0.06||||||95.0||||||||Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination|
1735740|NCT00488683|3196065|Superiority or Other||Spearman correlation coefficient|0.2||||0.1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination|
1735741|NCT00488683|3196065|Superiority or Other||Spearman correlation coefficient|0.31||||0.01||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination|
1735742|NCT00488683|3196065|Superiority or Other||Pearson correlation coefficient|0.5|||<|0.001||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination|
1735743|NCT00488683|3196065|Superiority or Other||Pearson correlation coefficient|0.24|||<|0.06||95.0|||||Parametric correlation|||Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration one month after booster vaccination|
1735744|NCT00488683|3196065|Superiority or Other||R-square|0.11|||<|0.001||95.0|||||Regression, Linear||Values from Group 1, 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age|
1735745|NCT00488683|3196065|Superiority or Other||Spearman correlation coefficient|0.46|||<|0.001||95.0|||||Non-parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age|
1735746|NCT00488683|3196065|Superiority or Other||Pearson correlation coefficient|0.33|||<|0.001||95.0|||||Parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific IgG concentration at 12 months of age|
1735747|NCT00488683|3196065|Superiority or Other||R-square|0.05|||<|||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination|
1735748|NCT00488683|3196065|Superiority or Other||R-square|0.02|||<|||95.0||||||||Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination|
1735749|NCT00488683|3196065|Superiority or Other||Spearman Correlation Coefficient|0.22|||<|0.26||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination|
1735750|NCT00488683|3196065|Superiority or Other||Spearman correlation coefficient|-0.05|||<|0.84||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination|
1735751|NCT00488683|3196065|Superiority or Other||Pearson correlation coefficient|0.21|||<|0.26||95.0|||||Parametric correlation||Values from Groups 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells one month after booster vaccination|
1735752|NCT00488683|3196065|Superiority or Other||Pearson correlation coefficient|-0.15|||<|0.53||95.0|||||Parametric correlation|||Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells 1 month after booster vaccination|
1735753|NCT00488683|3196065|Superiority or Other||R-square|0.21|||<|||95.0|||||||Values from Group 1, 2 and 3 were combined for this analysis.|Linear regression coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age|
1735754|NCT00488683|3196065|Superiority or Other||Spearman correlation coefficient|0.41|||<|0.0021||95.0|||||Non-parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Spearman correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age|
1735755|NCT00488683|3196065|Superiority or Other||Pearson correlation coefficient|0.45|||<|0.0006||95.0|||||Parametric correlation||Values from Group 1, 2 and 3 were combined for this analysis.|Pearson correlation coefficient between CRM197 specific memory B cells one month after primary vaccination and CRM197 specific memory B cells at 12 months of age|
1735756|NCT00488683|3196066|Superiority or Other||R-square|0.17||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y|
1735757|NCT00488683|3196066|Superiority or Other||R-square|0.27||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135|
1735758|NCT00488683|3196066|Superiority or Other||R-square|0.0007||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C|
1736135|NCT00487240|3196332|Superiority or Other|||||||0.282||||||P-value for Total Basal Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country|||
1735759|NCT00488683|3196066|Superiority or Other||R-square|0.03||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A|
1735760|NCT00488683|3196066|Superiority or Other||Spearman correlation coefficient|0.14||||0.55||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y|
1735761|NCT00488683|3196066|Superiority or Other||Spearman correlation coefficient|0.37||||0.07||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135|
1735762|NCT00488683|3196066|Superiority or Other||Spearman correlation coefficient|0.27||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C|
1735763|NCT00488683|3196066|Superiority or Other||Spearman correlation coefficient|0.15||||0.52||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A|
1735764|NCT00488683|3196066|Superiority or Other||Pearson correlation coefficient|0.42||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup Y|
1735765|NCT00488683|3196066|Superiority or Other||Pearson correlation coefficient|0.51||||0.008||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup W-135|
1735766|NCT00488683|3196066|Superiority or Other||Pearson correlation coefficient|-0.03||||0.9||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup C|
1735767|NCT00488683|3196066|Superiority or Other||Pearson correlation coefficient|0.18||||0.46||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one week after booster vaccination for the serogroup A|
1735768|NCT00488683|3196066|Superiority or Other||R-square|0.96||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y|
1735769|NCT00488683|3196066|Superiority or Other||R-square|0.23||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135|
1735770|NCT00488683|3196066|Superiority or Other||R-square|0.12||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C|
1735771|NCT00488683|3196066|Superiority or Other||R-square|0.01||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A|
1735772|NCT00488683|3196066|Superiority or Other||Spearman correlation coefficient|0.89||||0.04||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y|
1735773|NCT00488683|3196066|Superiority or Other||Spearman correlation coefficient|0.39||||0.19||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135|
1735774|NCT00488683|3196066|Superiority or Other||Spearman correlation coefficient|0.57||||0.01||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C|
1735775|NCT00488683|3196066|Superiority or Other||Spearman correlation coefficient|-0.03||||0.91||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A|
1735776|NCT00488683|3196066|Superiority or Other||Pearson correlation coefficient|0.98||||0.003||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup Y|
1735777|NCT00488683|3196066|Superiority or Other||Pearson correlation coefficient|0.48||||0.1||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup W-135|
1735778|NCT00488683|3196066|Superiority or Other||Pearson correlation coefficient|0.35||||0.16||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup C|
1735779|NCT00488683|3196066|Superiority or Other||Pearson correlation coefficient|-0.08||||0.79||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one week after booster vaccination for the serogroup A|
1735780|NCT00488683|3196066|Superiority or Other||R-square|0.0||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup Y|
1735781|NCT00488683|3196066|Superiority or Other||R-square|0.0||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup W-135|
1735782|NCT00488683|3196066|Superiority or Other||R-square|1.0||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C|
1735783|NCT00488683|3196066|Superiority or Other||Spearman correlation coefficient|1.0||||||95.0||||||||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C|
1735784|NCT00488683|3196066|Superiority or Other||Pearson correlation coefficient|1.0||||||95.0||||||||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one week after booster vaccination for the serogroup C|
1735785|NCT00488683|3196066|Superiority or Other||R-square|0.15||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y|
1735786|NCT00488683|3196066|Superiority or Other||R-square|0.01||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135|
1735787|NCT00488683|3196066|Superiority or Other||R-square|0.2||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C|
1735788|NCT00488683|3196066|Superiority or Other||R-square|0.02||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A|
1735789|NCT00488683|3196066|Superiority or Other||Spearman correlation coefficient|0.28||||0.36||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y|
1735790|NCT00488683|3196066|Superiority or Other||Spearman correlation coefficient|0.25||||0.37||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135|
1735791|NCT00488683|3196066|Superiority or Other||Spearman correlation coefficient|0.41||||0.12||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C|
1735792|NCT00488683|3196066|Superiority or Other||Spearman correlation coefficient|-0.05||||0.88||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A|
1735793|NCT00488683|3196066|Superiority or Other||Pearson correlation coefficient|0.38||||0.2||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup Y|
1735794|NCT00488683|3196066|Superiority or Other||Pearson correlation coefficient|0.11||||0.69||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup W-135|
1735795|NCT00488683|3196066|Superiority or Other||Pearson correlation coefficient|0.44||||0.09||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup C|
1735796|NCT00488683|3196066|Superiority or Other||Pearson correlation coefficient|-0.14||||0.68||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific plasma cells one week after booster vaccination for the serogroup A|
1735797|NCT00488683|3196067|Superiority or Other||R-square|0.0||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y|
1735798|NCT00488683|3196067|Superiority or Other||R-square|0.01||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y|
1735799|NCT00488683|3196067|Superiority or Other||R-square|0.0018||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135|
1735800|NCT00488683|3196067|Superiority or Other||R-square|0.0048||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135|
1735801|NCT00488683|3196067|Superiority or Other||R-square|0.02||||||95.0|||||||Values from Groups 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C|
1735802|NCT00488683|3196067|Superiority or Other||R-square|0.01||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C|
1735803|NCT00488683|3196067|Superiority or Other||R-square|0.0057||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A|
1735804|NCT00488683|3196067|Superiority or Other||R-square|0.0015||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A|
1735805|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|-0.01||||0.95||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y|
1735806|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|-0.13||||0.6||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y|
1735807|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.08||||0.69||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for the analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135|
1735808|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.11||||0.62||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135|
1735809|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|-0.2||||0.24||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C|
1735810|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|-0.003||||0.99||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C|
1735811|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.17||||0.36||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A|
1735812|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.11||||0.62||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A|
1735813|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.002||||0.99||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y|
1735814|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.11||||0.67||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup Y|
1735815|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.04||||0.84||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135|
1735816|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.07||||0.75||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135|
1735817|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.13||||0.44||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C|
1735818|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.11||||0.58||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup C|
1735819|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|0.08||||0.7||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A|
1735820|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.04||||0.86||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and rise from pre-booster levels in serogroup specific IgG concentration one month after booster vaccination for the serogroup A|
1735821|NCT00488683|3196067|Superiority or Other||R-square|0.9||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y|
1735822|NCT00488683|3196067|Superiority or Other||R-square|0.0||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y|
1735823|NCT00488683|3196067|Superiority or Other||R-square|0.0||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135|
1735824|NCT00488683|3196067|Superiority or Other||R-square|0.0004||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135|
1735825|NCT00488683|3196067|Superiority or Other||R-square|0.1||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C|
1735826|NCT00488683|3196067|Superiority or Other||R-square|0.42||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C|
1736136|NCT00487240|3196332|Superiority or Other|||||||0.004||||||P-value for Total Bolus Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country|||
1735827|NCT00488683|3196067|Superiority or Other||R-square|0.02||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A|
1735828|NCT00488683|3196067|Superiority or Other||R-square|0.69||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A|
1735829|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|-0.378||||0.25||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y|
1735830|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.26||||0.74||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y|
1735831|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.22||||0.3||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135|
1735832|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.48||||0.07||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135|
1735833|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.41||||0.03||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C|
1735834|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.28||||0.2||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C|
1735835|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.21||||0.4||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A|
1735836|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.52||||0.09||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A|
1735837|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.3||||0.37||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y|
1735838|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|0.004||||1||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup Y|
1735839|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.0003||||1||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135|
1735840|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.02||||0.94||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup W-135|
1735841|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|0.31||||0.11||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C|
1735842|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|0.65||||0.001||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup C|
1735843|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|0.14||||0.57||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A|
1735844|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|0.83||||0.001||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers rise from pre-booster to one month after booster vaccination for the serogroup A|
1735845|NCT00488683|3196067|Superiority or Other||R-square|0.01||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y|
1735846|NCT00488683|3196067|Superiority or Other||R-square|0.6||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y|
1735847|NCT00488683|3196067|Superiority or Other||R-square|0.03||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135|
1736137|NCT00487240|3196332|Superiority or Other|||||||0.023||||||P-value for Total Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country|||
1735848|NCT00488683|3196067|Superiority or Other||R-square|0.19||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135|
1735849|NCT00488683|3196067|Superiority or Other||R-square|0.05||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C|
1735850|NCT00488683|3196067|Superiority or Other||R-square|0.13||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C|
1735851|NCT00488683|3196067|Superiority or Other||R-square|0.01||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A|
1735852|NCT00488683|3196067|Superiority or Other||R-square|0.06||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A|
1735853|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|-0.25||||0.34||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y|
1735854|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.49||||0.18||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y|
1735855|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|-0.32||||0.12||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135|
1735856|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.72||||0.001||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135|
1735857|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.36||||0.06||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C|
1735858|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|0.28||||0.24||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C|
1735859|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|-0.19||||-0.51||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A|
1735860|NCT00488683|3196067|Superiority or Other||Spearman correlation coefficient|-0.25||||0.58||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A|
1735861|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.12||||0.65||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y|
1735862|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|0.77||||0.02||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup Y|
1735863|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.17||||0.42||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135|
1735864|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|0.43||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup W-135|
1735865|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|0.22||||0.26||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C|
1735866|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|0.36||||0.12||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup C|
1735867|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.12||||0.68||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A|
1735868|NCT00488683|3196067|Superiority or Other||Pearson correlation coefficient|-0.25||||0.59||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells rise from pre-booster to one month after booster vaccination for the serogroup A|
1736598|NCT00481195|3197064|Superiority or Other|||||||0.6475|||||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder|||
1735869|NCT00488683|3196068|Superiority or Other||R-square|0.08||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y|
1735870|NCT00488683|3196068|Superiority or Other||R-square|0.0023||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y|
1735871|NCT00488683|3196068|Superiority or Other||R-square|0.06||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135|
1735872|NCT00488683|3196068|Superiority or Other||R-square|0.07||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135|
1735873|NCT00488683|3196068|Superiority or Other||R-square|0.0077||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C|
1735874|NCT00488683|3196068|Superiority or Other||R-square|0.0002||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C|
1735875|NCT00488683|3196068|Superiority or Other||R-square|0.0027||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A|
1735876|NCT00488683|3196068|Superiority or Other||R-square|0.08||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A|
1735877|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.33||||0.04||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y|
1735878|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.18||||0.34||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y|
1735879|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.19||||0.2||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135|
1735880|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.39||||0.02||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135|
1735881|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.02||||0.9||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C|
1735882|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|-0.1||||0.51||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C|
1735883|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.08||||0.59||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A|
1735884|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.36||||0.02||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A|
1735885|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.28||||0.07||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y|
1735886|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|-0.05||||0.81||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup Y|
1735887|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.25||||0.09||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135|
1735888|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.27||||0.12||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup W-135|
1735889|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|-0.09||||0.51||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C|
1735890|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|-0.01||||0.94||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup C|
1735891|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.05||||0.74||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A|
1735892|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.29||||0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and serogroup specific IgG concentration one month after booster vaccination for the serogroup A|
1735893|NCT00488683|3196068|Superiority or Other||R-square|0.02||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y|
1735894|NCT00488683|3196068|Superiority or Other||R-square|0.02||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y|
1735895|NCT00488683|3196068|Superiority or Other||R-square|0.66||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135|
1735896|NCT00488683|3196068|Superiority or Other||R-square|0.1||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135|
1735897|NCT00488683|3196068|Superiority or Other||R-square|0.08||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C|
1735898|NCT00488683|3196068|Superiority or Other||R-square|0.22||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C|
1735899|NCT00488683|3196068|Superiority or Other||R-square|0.001||||||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A|
1735900|NCT00488683|3196068|Superiority or Other||R-square|0.59||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A|
1735901|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|-0.07||||0.84||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y|
1735902|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.35||||0.56||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y|
1735903|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.35||||0.1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135|
1735904|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.51||||0.04||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135|
1735905|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.47||||0.09||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C|
1735906|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.2||||0.35||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C|
1735907|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.14||||0.53||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A|
1735908|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.51||||0.03||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A|
1735909|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|-0.15||||0.66||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y|
1735910|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.15||||0.82||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup Y|
1735911|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.81|||<|0.0001||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135|
1735912|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.31|||<|0.22||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup W-135|
1735913|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.29|||<|0.12||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C|
1741664|NCT00432809|3203962|Superiority or Other|||||||0.1|||||||Chi-squared||||
1735914|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.47|||<|0.02||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup C|
1735915|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.03|||<|0.9||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A|
1735916|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.77|||<|0.0002||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and hSBA titers one month after booster vaccination for the serogroup A|
1735917|NCT00488683|3196068|Superiority or Other||R-square|0.03|||<|||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y|
1735918|NCT00488683|3196068|Superiority or Other||R-square|0.59|||<|||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y|
1735919|NCT00488683|3196068|Superiority or Other||R-square|0.007|||<|||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135|
1735920|NCT00488683|3196068|Superiority or Other||R-square|0.19|||<|||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135|
1735921|NCT00488683|3196068|Superiority or Other||R-square|0.06|||<|||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C|
1735922|NCT00488683|3196068|Superiority or Other||R-square|0.0|||<|||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C|
1735923|NCT00488683|3196068|Superiority or Other||R-square|0.02|||<|||95.0|||||||Values from Group 2 and 3 were combined for this analysis.|Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A|
1735924|NCT00488683|3196068|Superiority or Other||R-square|0.07|||<|||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A|
1735925|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.22|||<|0.34||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for the analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y|
1735926|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.39|||<|0.24||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y|
1735927|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.0|||<|1||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135|
1735928|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.72|||<|0.001||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135|
1735929|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.4|||<|0.03||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C|
1735930|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|0.12|||<|0.6||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C|
1735931|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|-0.21|||<|0.4||95.0|||||Non-parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A|
1735932|NCT00488683|3196068|Superiority or Other||Spearman correlation coefficient|-0.26|||<|0.46||95.0|||||Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A|
1735933|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.16|||<|0.48||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y|
1735934|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.77|||<|0.006||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup Y|
1735935|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|-0.08|||<|0.68||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135|
1735936|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.43|||<|0.08||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup W-135|
1741665|NCT00432809|3203962|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1735937|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.24|||<|0.2||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C|
1735938|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|0.006|||<|0.98||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup C|
1735939|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|-0.14|||<|0.59||95.0|||||Parametric correlation||Values from Group 2 and 3 were combined for this analysis.|Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A|
1735940|NCT00488683|3196068|Superiority or Other||Pearson correlation coefficient|-0.26|||<|0.46||95.0|||||Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccination and memory B cells one month after booster vaccination for the serogroup A|
1735941|NCT00488683|3196069|Superiority or Other||R-square|0.21||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y|
1735942|NCT00488683|3196069|Superiority or Other||R-square|0.04||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135|
1735943|NCT00488683|3196069|Superiority or Other||R-square|0.0059||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C|
1735944|NCT00488683|3196069|Superiority or Other||R-square|0.0029||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A|
1735945|NCT00488683|3196069|Superiority or Other||Spearman correlation coefficient|0.23||||0.06||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y|
1735946|NCT00488683|3196069|Superiority or Other||Spearman correlation coefficient|0.2||||0.07||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135|
1735947|NCT00488683|3196069|Superiority or Other||Spearman correlation coefficient|0.11||||0.27||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C|
1735948|NCT00488683|3196069|Superiority or Other||Spearman correlation coefficient|-0.04||||0.75||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A|
1735949|NCT00488683|3196069|Superiority or Other||Pearson correlation coefficient|0.45|||<|0.001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup Y|
1735950|NCT00488683|3196069|Superiority or Other||Pearson correlation coefficient|0.2|||<|0.08||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup W-135|
1735951|NCT00488683|3196069|Superiority or Other||Pearson correlation coefficient|0.08|||<|0.46||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup C|
1735952|NCT00488683|3196069|Superiority or Other||Pearson correlation coefficient|0.05|||<|0.68||95.0||||Values from Group 1, 2 and 2 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and serogroup specific IgG concentration at 12 months of age for the serogroup A|
1735953|NCT00488683|3196069|Superiority or Other||R-square|0.82|||<|||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y|
1735954|NCT00488683|3196069|Superiority or Other||R-square|0.43|||<|||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135|
1735955|NCT00488683|3196069|Superiority or Other||R-square|0.02|||<|||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C|
1735956|NCT00488683|3196069|Superiority or Other||R-square|0.005|||<|||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A|
1735957|NCT00488683|3196069|Superiority or Other||Spearman correlation coefficient|0.46|||<|0.004||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y|
1735958|NCT00488683|3196069|Superiority or Other||Spearman correlation coefficient|0.3|||<|0.04||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135|
1735959|NCT00488683|3196069|Superiority or Other||Spearman correlation coefficient|-0.05|||<|0.7||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C|
1735960|NCT00488683|3196069|Superiority or Other||Spearman correlation coefficient|0.01|||<|0.94||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A|
1735961|NCT00488683|3196069|Superiority or Other||Pearson correlation coefficient|0.9|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup Y|
1735962|NCT00488683|3196069|Superiority or Other||Pearson correlation coefficient|0.66|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup W-135|
1735963|NCT00488683|3196069|Superiority or Other||Pearson correlation coefficient|-0.13|||<|0.37||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup C|
1735964|NCT00488683|3196069|Superiority or Other||Pearson correlation coefficient|-0.07|||<|0.7||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and memory B cells at 12 months of age for the serogroup A|
1735965|NCT00488683|3196070|Superiority or Other||R-square|0.45||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y|
1735966|NCT00488683|3196070|Superiority or Other||R-square|0.66||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135|
1735967|NCT00488683|3196070|Superiority or Other||R-square|0.02||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C|
1735968|NCT00488683|3196070|Superiority or Other||R-square|0.004||||||95.0||||||||Linear regression coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A|
1735969|NCT00488683|3196070|Superiority or Other||Spearman correlation coefficient|0.4||||0.08||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y|
1735970|NCT00488683|3196070|Superiority or Other||Spearman correlation coefficient|0.45||||0.002||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135|
1735971|NCT00488683|3196070|Superiority or Other||Spearman correlation coefficient|0.31||||0.02||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C|
1735972|NCT00488683|3196070|Superiority or Other||Spearman correlation coefficient|-0.08||||0.61||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Non-parametric correlation|||Spearman correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A|
1735973|NCT00488683|3196070|Superiority or Other||Pearson correlation coefficient|0.67||||0.001||95.0||||Values from Groups I, II and III were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup Y|
1735974|NCT00488683|3196070|Superiority or Other||Pearson correlation coefficient|0.81|||<|0.0001||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup W-135|
1735975|NCT00488683|3196070|Superiority or Other||Pearson correlation coefficient|0.14|||<|0.3||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup C|
1735976|NCT00488683|3196070|Superiority or Other||Pearson correlation coefficient|-0.06|||<|0.69||95.0||||Values from Group 1, 2 and 3 were combined for this analysis.|Parametric correlation|||Pearson correlation coefficient between memory B cells one month after primary vaccinations and hSBA titers at 12 months of age for the serogroup A|
1735977|NCT00488631|3196072|Superiority or Other|||||||0.423||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.|
1735978|NCT00488631|3196072|Superiority or Other|||||||0.279||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at Week 54 and not receiving concomitant corticosteroids among participants on corticosteroids at Week 0 of maintenance study were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.|
1735979|NCT00488631|3196073|Superiority or Other|||||||0.098||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.|
1735980|NCT00488631|3196073|Superiority or Other|||||||0.365||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and 54 among participants with clinical remission at Week 0 of maintenance study were summarized using CMH test stratified by the induction dose factor.|
1735981|NCT00488631|3196074|Superiority or Other|||||||0.002||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.|
1735982|NCT00488631|3196074|Superiority or Other|||||||0.011||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with mucosal healing at both Week 30 and Week 54 were summarized using CMH test stratified by clinical remission status at Week 0 and the induction dose factor.|
1735983|NCT00488631|3196075|Superiority or Other|||||||0.004||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.|
1735984|NCT00488631|3196075|Superiority or Other|||||||0.122||||||Fixed sequence testing; 100 mg group was tested if it was positive for preceding endpoint, regardless whether 50 mg group was positive;50 mg group was tested if 100 mg group positive for same endpoint and 50 mg group positive for preceding endpoint.|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants with clinical remission at both Week 30 and Week 54 were summarized using the CMH test stratified by clinical remission status at Week 0 and the induction dose factor.|
1735985|NCT00488631|3196076|Superiority or Other||||||<|0.001||||||A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.|
1735986|NCT00488631|3196076|Superiority or Other||||||<|0.01||||||A fixed sequence testing procedure was employed to control the overall Type I error rate at the 0.05 level (i.e., testing golimumab 100 mg vs. placebo first, then, if positive, testing 50 mg vs. placebo).|Cochran-Mantel-Haenszel|||Statistical analysis for number of participants in clinical response through Week 54 were summarized using the Cochran-Mantel-Haenszel (CMH) test stratified by clinical remission status at Week 0 and the induction dose factor.|
1735987|NCT00488618|3196077|Superiority or Other||Least Squares Mean Difference|-0.64||||0.0001|2-Sided|95.0|-0.97|-0.32|||ANCOVA||cariprazine - placebo||
1735988|NCT00488618|3196078|Superiority or Other||Least Squares Mean Difference|-6.1|||<|0.0001|2-Sided|95.0|-8.9|-3.3|||ANCOVA||cariprazine - placebo||
1735989|NCT00488293|3196171|Superiority or Other|||||||0.65|||||||Chi-squared||||
1735990|NCT00488293|3196172|Superiority or Other|||||||0.22|||||||t-test, 2 sided||||
1735991|NCT00488293|3196173|Superiority or Other|||||||0.73|||||||t-test, 2 sided||||
1735992|NCT00488293|3196174|Superiority or Other|||||||0.36|||||||t-test, 2 sided||||
1735993|NCT00488293|3196175|Superiority or Other|||||||0.61|||||||t-test, 2 sided||||
1735994|NCT00488293|3196176|Superiority or Other|||||||0.81|||||||t-test, 2 sided||||
1735995|NCT00488293|3196177|Superiority or Other|||||||0.22|||||||t-test, 2 sided||||
1735996|NCT00488293|3196178|Superiority or Other|||||||0.39|||||||t-test, 2 sided||||
1735997|NCT00488293|3196179|Superiority or Other|||||||0.88|||||||Chi-squared||||
1735998|NCT00488293|3196180|Superiority or Other|||||||0.66|||||||t-test, 2 sided||||
1735999|NCT00487942|3196202|Superiority or Other||Effect size|-0.47|||||2-Sided|95.0|-1.28|0.34||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736000|NCT00487942|3196202|Superiority or Other||Effect size|-0.19|||||2-Sided|95.0|-0.99|0.62||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736001|NCT00487942|3196202|Superiority or Other||Effect size|0.06|||||2-Sided|95.0|-0.75|0.86||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736138|NCT00487240|3196333|Non-Inferiority or Equivalence|A noninferiority margin of 1.5 kg was chosen to prove noninferiority of ILPS to detemir.|Mean Difference (Net)|0.97||||0.003||95.0|0.34|1.6||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country.|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|If the first secondary null hypothesis (glycemic variability) is rejected, then the second secondary hypothesis (weight change) is tested at an error rate of 0.05.|
1736002|NCT00487942|3196203|Superiority or Other||Effect size|-0.43|||||2-Sided|95.0|-1.24|0.38||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736003|NCT00487942|3196203|Superiority or Other||Effect size|-0.07|||||2-Sided|95.0|-0.87|0.73||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736004|NCT00487942|3196203|Superiority or Other||Effect size|-0.15|||||2-Sided|95.0|-0.95|0.65||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736005|NCT00487942|3196204|Superiority or Other||Effect size|-0.3|||||2-Sided|95.0|-1.11|0.5||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736006|NCT00487942|3196204|Superiority or Other||Effect size|-0.02|||||2-Sided|95.0|-0.79|0.74||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736007|NCT00487942|3196204|Superiority or Other||Effect size|0.11|||||2-Sided|95.0|-0.64|0.87||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736008|NCT00487942|3196205|Superiority or Other||Effect size|-0.23|||||2-Sided|95.0|-1.01|0.56||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736009|NCT00487942|3196205|Superiority or Other||Effect size|0.03|||||2-Sided|95.0|-0.73|0.78||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736010|NCT00487942|3196205|Superiority or Other||Effect size|0.25|||||2-Sided|95.0|-0.51|1.01||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the ESS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736011|NCT00487942|3196206|Superiority or Other||Effect size|0.66|||||2-Sided|95.0|-0.16|1.49||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736012|NCT00487942|3196206|Superiority or Other||Effect size|0.18|||||2-Sided|95.0|-0.62|0.98||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736013|NCT00487942|3196206|Superiority or Other||Effect size|0.0|||||2-Sided|95.0|-0.8|0.8||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736014|NCT00487942|3196207|Superiority or Other||Effect size|0.03|||||2-Sided|95.0|-0.77|0.83||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736015|NCT00487942|3196207|Superiority or Other||Effect size|0.07|||||2-Sided|95.0|-0.73|0.87||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736016|NCT00487942|3196207|Superiority or Other||Effect size|-0.12|||||2-Sided|95.0|-0.92|0.68||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736017|NCT00487942|3196208|Superiority or Other||Effect size|0.3|||||2-Sided|95.0|-0.51|1.11||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736018|NCT00487942|3196208|Superiority or Other||Effect size|-0.28|||||2-Sided|95.0|-1.05|0.5||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736019|NCT00487942|3196208|Superiority or Other||Effect size|-0.5|||||2-Sided|95.0|-1.27|0.27||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736020|NCT00487942|3196209|Superiority or Other||Effect size|0.73|||||2-Sided|95.0|-0.08|1.54||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736021|NCT00487942|3196209|Superiority or Other||Effect size|-0.11|||||2-Sided|95.0|-0.87|0.64||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736022|NCT00487942|3196209|Superiority or Other||Effect size|0.11|||||2-Sided|95.0|-0.64|0.87||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736023|NCT00487942|3196210|Superiority or Other||Effect size|1.62|||||2-Sided|95.0|0.7|2.55||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736024|NCT00487942|3196210|Superiority or Other||Effect size|0.55|||||2-Sided|95.0|-0.27|1.36||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736025|NCT00487942|3196210|Superiority or Other||Effect size|0.02|||||2-Sided|95.0|-0.78|0.82||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736026|NCT00487942|3196211|Superiority or Other||Effect size|0.75|||||2-Sided|95.0|-0.08|1.58||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736139|NCT00487240|3196335|Superiority or Other|||||||0.038||||||P-value for Overall Severe Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.|||
1736140|NCT00487240|3196335|Superiority or Other|||||||0.017||||||P-value for Endpoint Severe Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.|||
1736027|NCT00487942|3196211|Superiority or Other||Effect size|0.29|||||2-Sided|95.0|-0.52|1.09||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736028|NCT00487942|3196211|Superiority or Other||Effect size|-0.25|||||2-Sided|95.0|-1.05|0.55||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736029|NCT00487942|3196212|Superiority or Other||Effect size|0.89|||||2-Sided|95.0|0.05|1.74||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736030|NCT00487942|3196212|Superiority or Other||Effect size|-0.1|||||2-Sided|95.0|-0.87|0.67||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736031|NCT00487942|3196212|Superiority or Other||Effect size|-0.3|||||2-Sided|95.0|-1.06|0.46||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736032|NCT00487942|3196213|Superiority or Other||Effect size|1.69|||||2-Sided|95.0|0.78|2.6||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736033|NCT00487942|3196213|Superiority or Other||Effect size|0.13|||||2-Sided|95.0|-0.63|0.88||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736034|NCT00487942|3196213|Superiority or Other||Effect size|0.11|||||2-Sided|95.0|-0.65|0.87||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the PANSS Negative Scale score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736035|NCT00487942|3196214|Superiority or Other||Effect size|0.08|||||2-Sided|95.0|-0.72|0.89||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736036|NCT00487942|3196214|Superiority or Other||Effect size|-0.08|||||2-Sided|95.0|-0.88|0.72||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736037|NCT00487942|3196214|Superiority or Other||Effect size|-0.08|||||2-Sided|95.0|-0.88|0.72||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736038|NCT00487942|3196215|Superiority or Other||Effect size|-0.17|||||2-Sided|95.0|-0.97|0.63||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736141|NCT00487240|3196335|Superiority or Other|||||||0.531||||||P-value for Overall Non-Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.|||
1736142|NCT00487240|3196335|Superiority or Other|||||||0.579||||||P-value for Endpoint Non-Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.|||
1736039|NCT00487942|3196215|Superiority or Other||Effect size|-0.18|||||2-Sided|95.0|-0.98|0.62||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736040|NCT00487942|3196215|Superiority or Other||Effect size|-0.62|||||2-Sided|95.0|-1.44|0.2||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736041|NCT00487942|3196216|Superiority or Other||Effect size|0.0|||||2-Sided|95.0|-0.8|0.81||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736042|NCT00487942|3196216|Superiority or Other||Effect size|0.05|||||2-Sided|95.0|-0.72|0.82||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736043|NCT00487942|3196216|Superiority or Other||Effect size|-0.13|||||2-Sided|95.0|-0.88|0.63||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736044|NCT00487942|3196217|Superiority or Other||Effect size|0.11|||||2-Sided|95.0|-0.68|0.89||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736045|NCT00487942|3196217|Superiority or Other||Effect size|-0.31|||||2-Sided|95.0|-1.06|0.45||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736046|NCT00487942|3196217|Superiority or Other||Effect size|-0.05|||||2-Sided|95.0|-0.8|0.71||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SANS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736047|NCT00487942|3196220|Superiority or Other||Effect size|-0.1|||||2-Sided|95.0|-0.9|0.7||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736048|NCT00487942|3196220|Superiority or Other||Effect size|-0.05|||||2-Sided|95.0|-0.85|0.75||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736049|NCT00487942|3196220|Superiority or Other||Effect size|-0.24|||||2-Sided|95.0|-1.06|0.58||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736050|NCT00487942|3196221|Superiority or Other||Effect size|-0.69|||||2-Sided|95.0|-1.51|0.14||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736143|NCT00487240|3196335|Superiority or Other|||||||0.001||||||P-value for Overall Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.|||
1736144|NCT00487240|3196335|Superiority or Other|||||||0.042||||||P-value for Endpoint Nocturnal Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.|||
1736051|NCT00487942|3196221|Superiority or Other||Effect size|-0.29|||||2-Sided|95.0|-1.09|0.52||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736052|NCT00487942|3196221|Superiority or Other||Effect size|-0.41|||||2-Sided|95.0|-1.21|0.4||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736053|NCT00487942|3196222|Superiority or Other||Effect size|-0.05|||||2-Sided|95.0|-0.84|0.73||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736054|NCT00487942|3196222|Superiority or Other||Effect size|-0.13|||||2-Sided|95.0|-0.89|0.63||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736055|NCT00487942|3196222|Superiority or Other||Effect size|-0.38|||||2-Sided|95.0|-1.14|0.38||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736056|NCT00487942|3196223|Superiority or Other||Effect size|0.37|||||2-Sided|95.0|-0.54|1.27||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736057|NCT00487942|3196223|Superiority or Other||Effect size|-0.1|||||2-Sided|95.0|-0.98|0.78||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736058|NCT00487942|3196223|Superiority or Other||Effect size|0.18|||||2-Sided|95.0|-0.75|1.1||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736059|NCT00487942|3196224|Superiority or Other||Effect size|-0.44|||||2-Sided|95.0|-1.33|0.45||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736060|NCT00487942|3196224|Superiority or Other||Effect size|-0.05|||||2-Sided|95.0|-0.91|0.81||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736061|NCT00487942|3196224|Superiority or Other||Effect size|0.33|||||2-Sided|95.0|-0.58|1.24||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736062|NCT00487942|3196225|Superiority or Other||Effect size|0.27|||||2-Sided|95.0|-0.61|1.15||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736145|NCT00487240|3196335|Superiority or Other|||||||0.193||||||P-value for Overall Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.|||
1736146|NCT00487240|3196335|Superiority or Other|||||||0.28||||||P-value for Endpoint Hypoglycemic Rate|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country. Hypoglycemic Rate (Adjusted for 1 year) was used in the analysis.|||
1736063|NCT00487942|3196225|Superiority or Other||Effect size|-0.33|||||2-Sided|95.0|-1.15|0.48||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736064|NCT00487942|3196225|Superiority or Other||Effect size|0.12|||||2-Sided|95.0|-0.76|1.0||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the SCoRS Total score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736065|NCT00487942|3196271|Superiority or Other||Effect size|-0.13|||||2-Sided|95.0|-0.95|0.7||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736066|NCT00487942|3196271|Superiority or Other||Effect size|-0.89|||||2-Sided|95.0|-1.69|-0.08||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736067|NCT00487942|3196271|Superiority or Other||Effect size|-0.44|||||2-Sided|95.0|-1.22|0.33||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the Trails B Test score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736068|NCT00487942|3196272|Superiority or Other||Effect size|-0.31|||||2-Sided|95.0|-1.12|0.49||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736069|NCT00487942|3196272|Superiority or Other||Effect size|0.25|||||2-Sided|95.0|-0.54|1.04||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736070|NCT00487942|3196272|Superiority or Other||Effect size|-0.15|||||2-Sided|95.0|-0.92|0.63||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736071|NCT00487942|3196273|Superiority or Other||Effect size|-0.1|||||2-Sided|95.0|-0.9|0.7||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736072|NCT00487942|3196273|Superiority or Other||Effect Size|-0.26|||||2-Sided|95.0|-1.05|0.53||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736073|NCT00487942|3196273|Superiority or Other||Effect size|-0.64|||||2-Sided|95.0|-1.43|0.15||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736074|NCT00487942|3196274|Superiority or Other||Effect size|0.02|||||2-Sided|95.0|-0.78|0.82||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736147|NCT00487240|3196336|Superiority or Other|||||||0.081||||||P-value for Overall Severe Hypoglycemic Episodes|Fisher Exact||||
1736148|NCT00487240|3196336|Superiority or Other|||||||0.053||||||P-value for Endpoint Severe Hypoglycemic Episodes|Fisher Exact||||
1736149|NCT00487240|3196336|Superiority or Other|||||||0.73||||||P-value for Overall Non-Nocturnal Hypoglycemic Episodes|Fisher Exact||||
1736075|NCT00487942|3196274|Superiority or Other||Effect size|0.55|||||2-Sided|95.0|-0.25|1.35||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736076|NCT00487942|3196274|Superiority or Other||Effect size|-0.51|||||2-Sided|95.0|-1.3|0.27||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736077|NCT00487942|3196275|Superiority or Other||Effect size|-0.16|||||2-Sided|95.0|-0.95|0.62||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736078|NCT00487942|3196275|Superiority or Other||Effect size|-0.35|||||2-Sided|95.0|-1.11|0.41||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736079|NCT00487942|3196275|Superiority or Other||Effect size|-0.2|||||2-Sided|95.0|-0.95|0.56||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736080|NCT00487942|3196276|Superiority or Other||Effect size|0.06|||||2-Sided|95.0|-0.72|0.85||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736081|NCT00487942|3196276|Superiority or Other||Effect size|0.34|||||2-Sided|95.0|-0.42|1.1||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736082|NCT00487942|3196276|Superiority or Other||Effect size|-0.23|||||2-Sided|95.0|-0.99|0.52||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736083|NCT00487942|3196277|Superiority or Other||Effect size|0.14|||||2-Sided|95.0|-0.64|0.93||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736084|NCT00487942|3196277|Superiority or Other||Effect Size|0.28|||||2-Sided|95.0|-0.48|1.04||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736085|NCT00487942|3196277|Superiority or Other||Effect Size|0.47|||||2-Sided|95.0|-0.3|1.23||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736086|NCT00487942|3196278|Superiority or Other||Effect Size|-0.2|||||2-Sided|95.0|-0.99|0.58||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736150|NCT00487240|3196336|Superiority or Other|||||||0.664||||||P-value for Endpoint Non-Nocturnal Hypoglycemic Episodes|Fisher Exact||||
1736151|NCT00487240|3196336|Superiority or Other|||||||0.287||||||P-value for Overall Nocturnal Episodes|Fisher Exact||||
1736152|NCT00487240|3196336|Superiority or Other|||||||0.157||||||P-value for Endpoint Nocturnal Hypoglycemic Episodes|Fisher Exact||||
1736087|NCT00487942|3196278|Superiority or Other||Effect Size|-0.45|||||2-Sided|95.0|-1.21|0.31||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736088|NCT00487942|3196278|Superiority or Other||Effect Size|-0.39|||||2-Sided|95.0|-1.16|0.37||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736089|NCT00487942|3196279|Superiority or Other||Effect Size|0.81|||||2-Sided|95.0|0.0|1.63||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736090|NCT00487942|3196279|Superiority or Other||Effect Size|0.08|||||2-Sided|95.0|-0.68|0.83||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736091|NCT00487942|3196279|Superiority or Other||Effect Size|0.46|||||2-Sided|95.0|-0.3|1.23||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736092|NCT00487942|3196280|Superiority or Other||Effect Size|-0.03|||||2-Sided|95.0|-0.82|0.75||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736093|NCT00487942|3196280|Superiority or Other||Effect Size|-0.66|||||2-Sided|95.0|-1.44|0.11||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736094|NCT00487942|3196280|Superiority or Other||Effect Size|-0.99|||||2-Sided|95.0|-1.79|-0.19||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736095|NCT00487942|3196281|Superiority or Other||Effect Size|-0.01|||||2-Sided|95.0|-0.8|0.77||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736096|NCT00487942|3196281|Superiority or Other||Effect Size|-0.05|||||2-Sided|95.0|-0.81|0.7||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736097|NCT00487942|3196281|Superiority or Other||Effect Size|0.39|||||2-Sided|95.0|-0.37|1.15||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736098|NCT00487942|3196282|Superiority or Other||Effect Size|0.13|||||2-Sided|95.0|-0.68|0.93||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736153|NCT00487240|3196336|Superiority or Other|||||||0.724||||||P-value for Overall Hypoglycemic Episodes|Fisher Exact||||
1736154|NCT00487240|3196336|Superiority or Other|||||||0.737||||||P-value for Endpoint Hypoglycemic Episodes|Fisher Exact||||
1736155|NCT00487240|3196337|Superiority or Other|||||||0.179||||||P-value for MODD|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736099|NCT00487942|3196282|Superiority or Other||Effect Size|0.34|||||2-Sided|95.0|-0.42|1.1||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736100|NCT00487942|3196282|Superiority or Other||Effect Size|0.45|||||2-Sided|95.0|-0.33|1.23||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736101|NCT00487942|3196283|Superiority or Other||Effect Size|0.46|||||2-Sided|95.0|-0.34|1.25||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736102|NCT00487942|3196283|Superiority or Other||Effect Size|0.25|||||2-Sided|95.0|-0.5|1.01||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736103|NCT00487942|3196283|Superiority or Other||Effect Size|0.15|||||2-Sided|95.0|-0.61|0.9||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736104|NCT00487942|3196284|Superiority or Other||Effect Size|-0.1|||||2-Sided|95.0|-0.89|0.68||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736105|NCT00487942|3196284|Superiority or Other||Effect Size|-0.02|||||2-Sided|95.0|-0.77|0.74||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736106|NCT00487942|3196284|Superiority or Other||Effect Size|-0.32|||||2-Sided|95.0|-1.08|0.44||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736107|NCT00487942|3196285|Superiority or Other||Effect Size|-0.18|||||2-Sided|95.0|-0.97|0.6||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736108|NCT00487942|3196285|Superiority or Other||Effect Size|0.11|||||2-Sided|95.0|-0.65|0.88||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736109|NCT00487942|3196285|Superiority or Other||Effect Size|-0.27|||||2-Sided|95.0|-1.03|0.48||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736110|NCT00487942|3196286|Superiority or Other||Effect size|0.49|||||2-Sided|95.0|-0.31|1.28||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736156|NCT00487240|3196337|Superiority or Other|||||||0.132||||||P-value for M-Value|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736251|NCT00486018|3196547|Superiority or Other||Difference in percentage|4.5||||0.0141||95.0|1.6|9.9|||Fisher Exact||Exact confidence interval based on inverting the exact two-sided score test.||
1741667|NCT00432809|3203963|Superiority or Other|||||||0.23|||||||ANOVA||||
1736111|NCT00487942|3196286|Superiority or Other||Effect size|-0.1|||||2-Sided|95.0|-0.86|0.66||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736112|NCT00487942|3196286|Superiority or Other||Effect size|0.25|||||2-Sided|95.0|-0.51|1.01||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736113|NCT00487942|3196287|Superiority or Other||Effect size|0.16|||||2-Sided|95.0|-0.66|0.98||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736114|NCT00487942|3196287|Superiority or Other||Effect size|0.31|||||2-Sided|95.0|-0.51|1.14||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736115|NCT00487942|3196287|Superiority or Other||Effect size|0.02|||||2-Sided|95.0|-0.8|0.83||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736116|NCT00487942|3196288|Superiority or Other||Effect size|0.15|||||2-Sided|95.0|-0.66|0.95||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736117|NCT00487942|3196288|Superiority or Other||Effect size|0.09|||||2-Sided|95.0|-0.68|0.86||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736118|NCT00487942|3196288|Superiority or Other||Effect size|-0.04|||||2-Sided|95.0|-0.81|0.73||||||This study was not designed for hypothesis testing, but to gather information relative to the efficacy of armodafinil treatment in improving cognitive impairments in patients with schizophrenia. Inferential statistics were not performed. Effect sizes and 95% confidence intervals of the effect sizes for the change from baseline in the composite score are provided for each armodafinil treated group compared with placebo. Actual changes from baseline are summarized using descriptive statistics.|
1736119|NCT00487695|3196300|Superiority or Other||||||<|0.0001|||||||Wilcoxon signed-rank|||The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy|
1736120|NCT00487695|3196301|Superiority or Other|||||||1|||||||Wilcoxon signed-rank|||The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared. This analysis looks at the patients referred for Barrett's surveillance EGD (no suspected neoplasia).|
1736121|NCT00487695|3196303|Superiority or Other|||||||0.002|||||||wilcoxon signed rank test|||The null hypothesis would be that CLE does not decrease the number of biopsies needed to make a diagnosis compared to standard endoscopy|
1736122|NCT00487695|3196304|Superiority or Other|||||||0.89|||||||Wilcoxon signed-rank|||The number of biopsies showing neoplasia was determined for each procedure (confocal laser endomicroscopy, standard EGD). These were compared.|
1736123|NCT00487695|3196305|Superiority or Other|||||||0.01|||||||Wilcoxon signed rank|||Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. We estimated that the yield for neoplasia would increase from 10% to 40% using CLE and the calculated sample size was 37. We planned to enroll 48 patients to allow for possible dropouts.|
1736124|NCT00487539|3196318|Superiority or Other||||||<|0.0001|||||||ANOVA|on the van der Waerden normal scores|||
1736125|NCT00487539|3196318|Superiority or Other||||||<|0.0001|||||||ANOVA|on the van der Waerden normal scores|||
1736126|NCT00487539|3196319|Superiority or Other|||||||0.0001|||||||Chi-squared||||
1736127|NCT00487539|3196319|Superiority or Other|||||||0.0014|||||||Chi-squared||||
1736128|NCT00487539|3196320|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1736129|NCT00487539|3196320|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1736130|NCT00487539|3196321|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1736131|NCT00487539|3196321|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1736132|NCT00487240|3196331|Superiority or Other|||||||0.416||||||P-value for Total Basal Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country|||
1736133|NCT00487240|3196331|Superiority or Other|||||||0.19||||||P-value for Total Bolus Insulin|ANOVA|ANOVA Model: Variable=Treatment+Country|||
1736157|NCT00487240|3196337|Non-Inferiority or Equivalence|A noninferiority margin of 0.8 mmol/L was chosen to prove noninferiority of ILPS to detemir.|Mean Difference (Net)|0.36||||||95.0|-0.03|0.75|||||Least Squares Mean difference = Insulin Lispro Protamine Suspension - Detemir|If the primary analysis achieves statistical significance at a 0.05 level (that is, the null hypothesis for the primary analysis [primary outcome measure] is rejected), then the first secondary hypothesis (glycemic variability) is tested at an error rate of 0.05.|
1736158|NCT00487240|3196338|Superiority or Other|||||||0.567||||||P-value for Daily Mean SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736159|NCT00487240|3196338|Superiority or Other|||||||0.261||||||P-value for Evening SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736160|NCT00487240|3196338|Superiority or Other|||||||0.876||||||P-value for Midday SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736161|NCT00487240|3196338|Superiority or Other|||||||0.576||||||P-value for Actual Morning SMBG Excursion|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736162|NCT00487240|3196338|Superiority or Other|||||||0.516||||||P-value for Actual 0300 Hours|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736163|NCT00487240|3196338|Superiority or Other|||||||0.093||||||P-value for Actual Evening Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736164|NCT00487240|3196338|Superiority or Other|||||||0.586||||||P-value for Actual Evening Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736165|NCT00487240|3196338|Superiority or Other|||||||0.977||||||P-value for Actual Midday Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736166|NCT00487240|3196338|Superiority or Other|||||||0.763||||||P-value for Actual Midday Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736167|NCT00487240|3196338|Superiority or Other|||||||0.611||||||P-value for Actual Morning Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736168|NCT00487240|3196338|Superiority or Other|||||||0.275||||||P-value for Actual Morning Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736169|NCT00487240|3196338|Superiority or Other|||||||0.414||||||P-value for Daily Mean Morning and Evening Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736170|NCT00487240|3196338|Superiority or Other|||||||0.395||||||P-value for Daily Mean Postprandial Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736171|NCT00487240|3196338|Superiority or Other|||||||0.468||||||P-value for Daily Mean Pre-Meal|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736172|NCT00487240|3196338|Superiority or Other|||||||0.259||||||P-value for Daily Mean 7-Point SMBG.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|||
1736173|NCT00487240|3196339|Superiority or Other|||||||0.699||||||P-value for With HbA1c <6.5%|Fisher Exact||||
1736174|NCT00487240|3196339|Superiority or Other|||||||0.722||||||P-value for With HbA1c ≤6.5%|Fisher Exact||||
1736175|NCT00487240|3196339|Superiority or Other|||||||1||||||P-value for With HbA1c <7.0%|Fisher Exact||||
1736176|NCT00487240|3196339|Superiority or Other|||||||1||||||P-value for With HbA1c ≤7.0%.|Fisher Exact||||
1736177|NCT00487240|3196340|Superiority or Other||Mean Difference (Net)|-0.06||||0.599||95.0|-0.27|0.15||P-value for 32 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.||
1736178|NCT00487240|3196340|Superiority or Other||Mean Difference (Net)|-0.04||||0.704||95.0|-0.25|0.17||P-value for 24 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.||
1736179|NCT00487240|3196340|Superiority or Other||Mean Difference (Net)|-0.14||||0.187||95.0|-0.34|0.07||P-value for 16 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.||
1736180|NCT00487240|3196340|Superiority or Other||Mean Difference (Net)|-0.03||||0.718||95.0|-0.22|0.15||P-value for 8 Week Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment+Baseline+Country.|Least Squares Mean Difference=Insulin Lispro Protamine Suspension minus Detemir.||
1736181|NCT00487240|3196341|Non-Inferiority or Equivalence|Noninferiority limit of 0.4% using the upper limit of a two-sided test at a significance level of 0.05 with 90% power assuming a 1.1 Standard Deviations (SD)|Mean Difference (Net)|-0.1||||0.332||95.0|-0.29|0.1|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Country.|Least Squares Mean Difference = Insulin Lispro Protamine Suspension minus Detemir.|Hypothesis: basal analog insulin lispro protamine suspension (ILPS), is inferior to basal analog insulin detemir, as measured by change in HbA1c from baseline to endpoint.|
1736182|NCT00487084|3196358|Superiority or Other|||||||0.2|||||||Chi-squared, Corrected||||
1736183|NCT00487084|3196359|Superiority or Other|||||||0.01|||||||Chi-squared, Corrected||||
1736184|NCT00487084|3196359|Superiority or Other|||||||0.01|||||||Chi-squared, Corrected||||
1736185|NCT00487084|3196360|Superiority or Other||||||<|0.05|||||||Kruskal-Wallis||||
1736186|NCT00487084|3196360|Superiority or Other||||||<|0.05|||||||Kruskal-Wallis||||
1736187|NCT00487084|3196361|Superiority or Other|||||||0.009|||||||Log Rank||||
1736188|NCT00487084|3196361|Superiority or Other|||||||0.83|||||||Log Rank||||
1736189|NCT00487084|3196361|Superiority or Other|||||||0.006|||||||Log Rank|||A sample of 56 was estimated to have an 80% power to detect a 30% difference in the proportion of subjects with continuing analgesia in the MCS versus the SCM groups when 50% of the subjects in the SCM had requested supplemental analgesia. 28 subjects was added to compare the influence of time of morphine and 2-chloroprocaine administration to lidocaine-morphine analgesia. The primary outcome was compared using Kaplan-Meier survival analysis and the log-rank test.|
1736190|NCT00486954|3196405|Superiority or Other||Hazard Ratio (HR)|0.84||||0.2088|2-Sided|95.0|0.64|1.11|||Log Rank||||
1736191|NCT00486902|3196407|Superiority or Other||Median Difference (Net)|-0.6||||0.02|2-Sided|95.0|-1.1|-0.09|||Wilcoxon (Mann-Whitney)||||
1736192|NCT00486902|3196408|Superiority or Other|||||||1|||||||Fisher Exact||||
1736193|NCT00486902|3196409|Superiority or Other|||||||0.24|||||||Fisher Exact||||
1736194|NCT00486902|3196410|Superiority or Other|||||||0.9|||||||Fisher Exact||||
1736198|NCT00486902|3196414|Superiority or Other|||||||0.86|||||||Fisher Exact|||Sample size was determined assuming an incidence of breakthrough pain of 75% and an absolute difference between groups of -20 to +15%. This rate of request for analgesia in the first 24 h was based on data from a parallel study utilizing the same multimodal postoperative pain regimen for cesarean delivery. Group sample sizes of 90 achieve 80% power to detect this difference using the two-sided Z test with pooled variance. The significance level of the test was targeted at 0.05.|
1736199|NCT00486863|3196421|Superiority or Other|||||||0.991||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared||||
1736200|NCT00486863|3196426|Superiority or Other||||||<|0.001||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared||||
1736201|NCT00486863|3196427|Superiority or Other|||||||0.07||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Analysis included the transferrin receptor: ferritin ratio from the heel stick.|
1736202|NCT00486863|3196427|Superiority or Other|||||||0.524||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)|||Analysis included the transferrin receptor: ferritin ratio from the cord blood.|
1736203|NCT00486863|3196428|Superiority or Other|||||||0.517||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided||||
1736204|NCT00486863|3196429|Superiority or Other|||||||0.704||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided||||
1736205|NCT00486863|3196430|Superiority or Other|||||||0.439||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)||||
1736206|NCT00486863|3196431|Superiority or Other|||||||0.502||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Wilcoxon (Mann-Whitney)||||
1736207|NCT00486863|3196432|Superiority or Other|||||||0.926||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided||||
1736208|NCT00486863|3196433|Superiority or Other||||||>|0.999||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|Chi-squared||||
1736209|NCT00486863|3196434|Superiority or Other|||||||0.988||||||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.05.|t-test, 2 sided||||
1736210|NCT00486837|3196440|Superiority or Other|||||||0.197|||||||ANCOVA||||
1736211|NCT00486824|3196447|Superiority|||||||0.004|||||||Fisher Exact||||
1736212|NCT00486525|3196485|Superiority or Other||Slope|-0.56|Standard Error of the Mean|0.34||0.098|2-Sided|95.0|-1.2|0.1|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of CESD for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.|
1736213|NCT00486525|3196485|Superiority or Other||Slope|-0.66|Standard Error of the Mean|0.34||0.051|2-Sided|95.0|-1.3|0.0039|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of CES-D for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.|
1736214|NCT00486525|3196485|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|0.99||0.21|2-Sided|95.0|-3.2|0.69|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.|
1736215|NCT00486525|3196485|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.98||0.28|2-Sided|95.0|-3.0|0.88|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.|
1736216|NCT00486525|3196486|Superiority or Other||Slope|2.5|Standard Error of the Mean|0.85||0.0045|2-Sided|95.0|0.77|4.14|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.|
1736217|NCT00486525|3196486|Superiority or Other||Slope|2.1|Standard Error of the Mean|0.85||0.016|2-Sided|95.0|0.4|3.75|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.|
1736229|NCT00486525|3196489|Superiority or Other||Slope|-0.022|Standard Error of the Mean|0.021||0.3|2-Sided|95.0|-0.063|0.019|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.|
1741668|NCT00432809|3203963|Superiority or Other|||||||0.003|||||||ANOVA||||
1736218|NCT00486525|3196486|Superiority or Other||Mean Difference (Final Values)|6.6|Standard Error of the Mean|2.5||0.01|2-Sided|95.0|1.5|11.6|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.|
1736219|NCT00486525|3196486|Superiority or Other||Mean Difference (Final Values)|6.4|Standard Error of the Mean|2.5||0.01|2-Sided|95.0|1.4|11.4|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.|
1736220|NCT00486525|3196487|Superiority or Other||Slope|-2.8|Standard Error of the Mean|0.71||0.0001|2-Sided|95.0|-4.2|-1.4|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of MFSI-SF fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.|
1736221|NCT00486525|3196487|Superiority or Other||Slope|-1.7|Standard Error of the Mean|0.7||0.019|2-Sided|95.0|-3.1|-0.28|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of MFSI-SF Fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.|
1736222|NCT00486525|3196487|Superiority or Other||Mean Difference (Final Values)|-7.0|Standard Error of the Mean|2.2||0.002|2-Sided|95.0|-11.4|-2.7|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.|
1736223|NCT00486525|3196487|Superiority or Other||Mean Difference (Final Values)|-4.2|Standard Error of the Mean|2.2||0.058|2-Sided|95.0|-8.5|0.15|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.|
1736224|NCT00486525|3196488|Superiority or Other||Slope|-0.078|Standard Error of the Mean|0.036||0.03|2-Sided|95.0|-0.15|-0.0074|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.|
1736225|NCT00486525|3196488|Superiority or Other||Slope|-0.034|Standard Error of the Mean|0.0235||0.33|2-Sided|95.0|-0.1|0.035|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.|
1736226|NCT00486525|3196488|Superiority or Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.11||0.037|2-Sided|95.0|-0.44|-0.014|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.|
1736227|NCT00486525|3196488|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.11||0.33|2-Sided|95.0|-0.31|0.11|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.|
1736228|NCT00486525|3196489|Superiority or Other||Slope|-0.056|Standard Error of the Mean|0.022||0.01|2-Sided|95.0|-0.098|-0.013|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.|
1736249|NCT00486018|3196546|Superiority or Other||Difference in percentage|45.5|||<|0.0001||95.0|36.0|55.0|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) using Cochran–Mantel–Haenszel weights.||
1736230|NCT00486525|3196489|Superiority or Other||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|0.064||0.015|2-Sided|95.0|-0.28|-0.031|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.|
1736231|NCT00486525|3196489|Superiority or Other||Mean Difference (Final Values)|-0.079|Standard Error of the Mean|0.062||0.2|2-Sided|95.0|-0.2|-0.042|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.|
1736232|NCT00486525|3196490|Superiority or Other||Slope|-0.038|Standard Error of the Mean|0.02||0.063|2-Sided|95.0|-0.079|0.0021|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes 3 months post-treatment.|Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.|
1736233|NCT00486525|3196490|Superiority or Other||Slope|-0.021|Standard Error of the Mean|0.02||0.28|2-Sided|95.0|-0.06|0.018|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Model used continuous yoga practice frequency in place of group assignment to predict primary outcomes immediately post-treatment.|Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.|
1736234|NCT00486525|3196490|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.06||0.027|2-Sided|95.0|-0.25|-0.015|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control 3 months post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.|
1736235|NCT00486525|3196490|Superiority or Other||Mean Difference (Final Values)|-0.075|Standard Error of the Mean|0.058||0.2|2-Sided|95.0|-0.19|0.039|||Mixed Models Analysis|The Kenward-Roger adjustment to the degrees of freedom was used to control Type I error rates.|Yoga minus Control immediately post-treatment|Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.|
1736236|NCT00486291|3196501|Superiority or Other||Mean Difference (Final Values)|-6.5|Standard Error of the Mean|0.81|<|0.0001|2-Sided|95.0|-8.1|-4.9|||ANCOVA||||
1736237|NCT00486291|3196502|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.16||0.0007|2-Sided|95.0|-0.9|-0.2|||ANCOVA|||It is anticipated that the pooled standard deviation (SD) of the change from baseline in HbA1c will be between 1.0 and 1.5. With 90 subjects per treatment group the study will have 90% power (two-sided alpha=0.05) to detect a mean difference between groups of 0.486 for SD=1.0, and a mean difference between groups of 0.729 for SD=1.5.|
1736238|NCT00486044|3196537|Superiority or Other|||||||0.21|||||||Kruskal-Wallis||||
1736239|NCT00486044|3196538|Superiority or Other|||||||0.113|||||||Kruskal-Wallis||||
1736240|NCT00486044|3196539|Superiority or Other|||||||0.015|||||||ANCOVA||||
1736241|NCT00486044|3196540|Superiority or Other|||||||0.966|||||||Kruskal-Wallis||||
1736242|NCT00486018|3196543|Superiority or Other||Difference in Least Squares means|5.1||||0.0014||95.0|2.0|8.3|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline Distance Activities Subscale score.|||
1736243|NCT00486018|3196543|Superiority or Other||Difference in Least Squares means|3.8||||0.0248||95.0|0.5|7.0|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline Distance Activities Subscale score.|||
1736244|NCT00486018|3196544|Superiority or Other||Difference in Least Squares means|6.4||||0.0002||95.0|3.0|9.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline Near Activities Subscale score.|||
1736245|NCT00486018|3196544|Superiority or Other||Difference in Least Squares means|4.1||||0.0214||95.0|0.6|7.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline Near Activities Subscale score.|||
1736246|NCT00486018|3196545|Superiority or Other||Difference in Least Squares means|-134.8|||<|0.0001||95.0|-172.7|-96.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline value of central foveal thickness.|||
1736247|NCT00486018|3196545|Superiority or Other||Difference in Least Squares means|-148.7|||<|0.0001||95.0|-183.6|-113.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) and baseline value of central foveal thickness.|||
1736248|NCT00486018|3196546|Superiority or Other||Difference in percentage|40.1|||<|0.0001||95.0|29.9|50.2|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.||
1736250|NCT00486018|3196547|Superiority or Other||Difference in percentage|3.0||||0.2815||95.0|-1.5|8.3|||Fisher Exact||Exact confidence interval based on inverting the exact two-sided score test.||
1736252|NCT00486018|3196548|Superiority or Other||Difference in percentage|31.3|||<|0.0001||95.0|20.1|42.6|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.||
1736253|NCT00486018|3196548|Superiority or Other||Difference in percentage|26.8|||<|0.0001||95.0|15.6|38.0|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters) using Cochran–Mantel–Haenszel weights.||
1736254|NCT00486018|3196549|Superiority or Other||Difference in Least Squares means|10.6|||<|0.0001||95.0|7.6|13.6||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters).|||
1736255|NCT00486018|3196549|Superiority or Other||Difference in Least Squares means|9.4|||<|0.0001||95.0|6.6|12.2||The Hochberg–Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35–54, ≥ 55 letters).|||
1736256|NCT00485836|3196553|Superiority or Other||Difference in Least Squares means|4.1||||0.0199||95.0|0.7|7.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.|||
1736257|NCT00485836|3196553|Superiority or Other||Difference in Least Squares means|6.3||||0.0002||95.0|3.1|9.5|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.|||
1736258|NCT00485836|3196554|Superiority or Other||Difference in Least Squares means|4.9||||0.0099||95.0|1.2|8.6|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.|||
1736259|NCT00485836|3196554|Superiority or Other||Difference in Least Squares means|5.8||||0.0019||95.0|2.1|9.4|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.|||
1736260|NCT00485836|3196555|Superiority or Other||Difference in Least Squares means|-283.8|||<|0.0001||95.0|-337.8|-229.8|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.|||
1736261|NCT00485836|3196555|Superiority or Other||Difference in Least Squares means|-272.2|||<|0.0001||95.0|-329.9|-214.5|||ANCOVA|Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.|||
1736262|NCT00485836|3196556|Superiority or Other||Difference in percentage|54.0|||<|0.0001||95.0|44.0|64.1|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.||
1736263|NCT00485836|3196556|Superiority or Other||Difference in percentage|51.9|||<|0.0001||95.0|41.6|62.3|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.||
1736264|NCT00485836|3196557|Superiority or Other||Difference in percentage|13.6|||<|0.0001||95.0|7.2|20.1|||Cochran−Mantel−Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.||
1736265|NCT00485836|3196557|Superiority or Other||Difference in percentage|11.3|||<|0.0019||95.0|4.3|18.2|||Cochran−Mantel−Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.||
1736266|NCT00485836|3196558|Superiority or Other||Difference in percentage|30.3|||<|0.0001||95.0|19.6|40.9|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.||
1736267|NCT00485836|3196558|Superiority or Other||Difference in percentage|29.3|||<|0.0001||95.0|18.8|39.7|||Cochran-Mantel-Haenszel χ²|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.||
1736268|NCT00485836|3196559|Superiority or Other||Difference in Least Squares means|13.8|||<|0.0001||95.0|10.3|17.4||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|||
1736269|NCT00485836|3196559|Superiority or Other||Difference in Least Squares means|11.5|||<|0.0001||95.0|7.7|15.3||The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.|ANOVA|Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).|||
1736270|NCT00485758|3196560|Superiority or Other||Median Difference (Final Values)|-23.1|||<|0.001||95.0|-27.2|-18.9|||ANCOVA|Nonparametric Analysis of Covariance model based on Tukey’s normalized ranks with term for treatment, gender and Tukey's normal score of baseline.|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free Confidence Interval based on Wilcoxon’s rank||
1736271|NCT00485758|3196561|Superiority or Other||Mean Difference (Final Values)|23.2|Standard Error of the Mean|1.3|<|0.001||95.0|20.7|25.7|||Repeated Measures Analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline high-density lipoprotein cholesterol -by-time interaction.|||
1736272|NCT00485758|3196562|Superiority or Other||Mean Difference (Final Values)|-17.9|Standard Error of the Mean|1.8|<|0.001||95.0|-21.4|-14.4|||Wilcoxon (Mann-Whitney)|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline low-density lipoprotein cholesterol -by-time interaction.|||
1736273|NCT00485472|3196577|Superiority or Other||Odds Ratio (OR)|0.488||||0.0418||95.0|0.245|0.974|||Likelihood ratio test|||Analysis of 'response' based on a likelihood ratio test with treatment and pooled site as factors.|
1736274|NCT00485472|3196579|Superiority or Other||Mean Difference (Net)|10.74||||0.3445||95.0|-11.65|33.13|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.|
1736275|NCT00485472|3196580|Superiority or Other||Mean Difference (Net)|1.79||||0.665||95.0|-6.36|9.93|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.|
1736276|NCT00485472|3196581|Superiority or Other||Mean Difference (Net)|4.83||||0.2022||95.0|-2.62|12.28|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.|
1736277|NCT00485472|3196582|Superiority or Other||Mean Difference (Net)|2.36||||0.5438||95.0|-5.3|10.02|||ANCOVA|||The ANCOVA analysis includes treatment and pooled site as factors and baseline score as covariate.|
1736278|NCT00485173|3196607|Superiority or Other||||||<|0.001||||||P-value was from logistic regression model by using propensity score and any ossification 'Yes/No' at preop as the covariates.|Regression, Logistic|||Statistical analysis at 24 months postoperation.|
1736279|NCT00485173|3196608|Superiority or Other|||||||0.479||||||P-value was two-sided, obtained from Cox regression and adjusted with propensity scores.|Regression, Cox||||
1736280|NCT00485173|3196609|Superiority or Other|||||||0.341||||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA||||
1736281|NCT00485173|3196610|Superiority or Other||||||<|0.001||||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA||||
1736282|NCT00485173|3196611|Superiority or Other||||||<|0.001||||||P-value was two-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA||||
1736283|NCT00485173|3196612|Superiority or Other|||||||0.133||||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.|
1736284|NCT00485173|3196612|Non-Inferiority or Equivalence|The predefined non-inferiority margin was 0.10.|||||<|0.001||||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic||||
1736285|NCT00485173|3196613|Superiority or Other|||||||0.466||||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.|
1736286|NCT00485173|3196613|Non-Inferiority or Equivalence|The predefined non-inferiority margin was 0.10.||||||0.003||||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic||||
1736287|NCT00485173|3196614|Superiority or Other|||||||0.189||||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA||||
1736288|NCT00485173|3196615|Superiority or Other|||||||0.017||||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.|
1736289|NCT00485173|3196615|Non-Inferiority or Equivalence|The predefined non-inferiority margin was 0.10.|||||<|0.001||||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic||||
1736290|NCT00485173|3196616|Superiority or Other|||||||0.03||||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA||||
1736291|NCT00485173|3196617|Superiority or Other|||||||0.414||||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.|
1736292|NCT00485173|3196617|Non-Inferiority or Equivalence|The predefined non-inferiority margin was 0.10.||||||0.001||||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic||||
1736293|NCT00485173|3196618|Superiority or Other|||||||0.031||||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA||||
1736294|NCT00485173|3196619|Superiority or Other||||||<|0.001||||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.|
1736295|NCT00485173|3196619|Non-Inferiority or Equivalence|The predefined non-inferiority margin was 0.10.|||||<|0.001||||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic||||
1736296|NCT00485173|3196620|Superiority or Other|||||||0.063||||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA||||
1736297|NCT00485173|3196621|Superiority or Other|||||||0.011||||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.|
1736298|NCT00485173|3196621|Non-Inferiority or Equivalence|The predefined non-inferiority margin was 0.10.|||||<|0.001||||||P-value was one-sided from random sampling, based on covariance matrix produced by logistic regression using propensity score as a covariate.|Regression, Logistic||||
1736299|NCT00485173|3196622|Superiority or Other|||||||0.002||||||P-value was one-sided, adjusted from ANCOVA with the propensity score as the covariate.|ANCOVA||||
1736300|NCT00485173|3196623|Superiority or Other|||||||0.002||||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority analysis was performed if non-inferiority was demonstrated.|
1736301|NCT00485173|3196623|Non-Inferiority or Equivalence|The predefined non-inferiority margin was 0.10.|||||<|0.001||||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic||||
1736302|NCT00485173|3196624|Superiority or Other||||||<|0.001||||||P-value was one-sided, obtained from logistic regression model by using propensity score as a covariate.|Regression, Logistic|||Superiority comparison of success rates in two treatment groups was a secondary objective of this trial. Superiority analysis was performed if non-inferiority was demonstrated.|
1736599|NCT00481195|3197065|Superiority or Other|||||||0.4567|||||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder|||
1736303|NCT00485173|3196624|Non-Inferiority or Equivalence|The predefined non-inferiority margin was 0.10.|||||<|0.001||||||P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.|Regression, Logistic||||
1736304|NCT00484939|3196658|Superiority or Other|||||||0.13|||||||Log Rank||||
1736305|NCT00484939|3196661|Superiority or Other|||||||0.029|||||||Fisher Exact|||This statistical analysis compared the number of responders in the 2 treatment groups. A responder was defined as any participant with a best overall response of complete response or partial response. There were 28 responders in the bevacizumab + capecitabine group and 14 responders in the capecitabine group.|
1736306|NCT00484939|3196662|Superiority or Other||||||<|0.001|||||||Log Rank||||
1736307|NCT00484419|3196669|Superiority or Other|||||||0.0217|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736308|NCT00484419|3196669|Superiority or Other|||||||0.0566|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736309|NCT00484419|3196669|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736310|NCT00484419|3196670|Superiority or Other|||||||0.0999|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736311|NCT00484419|3196670|Superiority or Other|||||||0.1864|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736312|NCT00484419|3196670|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736313|NCT00484419|3196672|Superiority or Other|||||||0.2007|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736314|NCT00484419|3196672|Superiority or Other|||||||0.6117|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736315|NCT00484419|3196672|Superiority or Other|||||||0.2701|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736316|NCT00484419|3196673|Superiority or Other|||||||0.0001|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736317|NCT00484419|3196673|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736318|NCT00484419|3196673|Superiority or Other||||||<|0.0374|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736319|NCT00484419|3196675|Superiority or Other|||||||0.4528|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736320|NCT00484419|3196675|Superiority or Other|||||||0.1394|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736321|NCT00484419|3196675|Superiority or Other|||||||0.7094|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736322|NCT00484419|3196676|Superiority or Other|||||||0.1862|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736323|NCT00484419|3196676|Superiority or Other|||||||0.0257|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736324|NCT00484419|3196676|Superiority or Other|||||||0.8596|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736325|NCT00484419|3196679|Superiority or Other|||||||0.0125|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736326|NCT00484419|3196679|Superiority or Other|||||||0.0004|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736327|NCT00484419|3196679|Superiority or Other|||||||0.0133|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736328|NCT00484419|3196680|Superiority or Other|||||||0.0483|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736329|NCT00484419|3196680|Superiority or Other|||||||0.0004|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736330|NCT00484419|3196680|Superiority or Other|||||||0.0077|||||||t-test, 2 sided|||P-value presents results from 1-sample t-test for within-treatment difference from baseline.|
1736331|NCT00484419|3196683|Superiority or Other|||||||0.0011|||||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.|
1736332|NCT00484419|3196683|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.|
1736333|NCT00484419|3196683|Superiority or Other||||||<|0.0234|||||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.|
1736334|NCT00484419|3196684|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.|
1736335|NCT00484419|3196684|Superiority or Other||||||<|0.109|||||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.|
1736336|NCT00484419|3196684|Superiority or Other||||||<|0.0061|||||||t-test, 2 sided|||For a treatment group, assuming a within-subject standard deviation of at most 1.15, a 2-sided t-test of the null hypothesis that the change from baseline (CFB) is zero will have 67% to 85% power to detect a difference of 0.4 to 0.5 with a sample size of 50 randomized subjects.|
1736337|NCT00484315|3196692|Non-Inferiority or Equivalence|Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was < 0.20, given the data, was at least 95%. The sample size of 330 subjects (resulting in 280 after accounting for 15% attrition) was determined through simulations based on Bayesian modeling.|Mean Difference (Final Values)|-0.0294|Standard Deviation|0.08253||0.997|1-Sided|95.0||0.1078||P-value is posterior probability that the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express was < 0.20, given the data observed. Non-inferiority was concluded, as this probability is greater than 95%.|Bayesian modeling||Based on posterior distribution of the difference in mean ln(9-month percent diameter stenosis) between TAXUS Element and TAXUS Express. Upper limit is 1-Sided 95% posterior credible interval, based off the 95th percentile of posterior distribution.|Natural log (ln) transformation was used to improve normality of the secondary endpoint distribution. Bayesian modeling was used to determine if the mean ln(9-month percent diameter stenosis) for the TAXUS Element stent was non-inferior to the mean ln(9-month %DS) for TAXUS Express. Null hypothesis was that the TAXUS Element mean was at least 0.20 greater than the TAXUS Express mean. Alternative hypothesis was that the TAXUS Element mean is less than 0.20 greater than the TAXUS Express TLF mean.|
1736338|NCT00484315|3196693|Non-Inferiority or Equivalence|Non-inferiority of the TAXUS Element stent was to be accepted if the Bayesian posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was < 4.1%, given the data, was at least 95%. The sample size of 1264 subjects (resulting in 1200 after accounting for 5% attrition) was determined through simulations based on Bayesian modeling.|Median Difference (Final Values)|-0.57|Standard Deviation|0.0155||0.9996|1-Sided|95.0||1.85||The p-value is the posterior probability that the difference in 12-month TLF between TAXUS Element and TAXUS Express was < 4.1%, given the data observed.|Bayesian modeling||Values are based on the posterior distribution of the difference in TLF rates between TAXUS Element and TAXUS Express. The upper limit is the 1-Sided 95% posterior credible interval, based off the 95th percentile of the posterior distribution.|Bayesian modeling was used to determine if the 12-month TLF rate for the TAXUS Element stent was non-inferior to the 12-month TLF rate in the TAXUS Express2 control. The null hypothesis was that the TAXUS Element TLF rate is at least 4.1% greater than the TAXUS Express TLF rate. The alternative hypothesis was that the TAXUS Element TLF rate is less than 4.1% greater than the TAXUS Express TLF rate.|
1736339|NCT00483938|3196743|Superiority or Other|||||||1|||||||Fisher Exact|||Complete EVR: Group E versus Group F|
1736340|NCT00483938|3196743|Superiority or Other|||||||0.363|||||||Fisher Exact|||Complete EVR: Group C versus Group D|
1736341|NCT00483938|3196743|Superiority or Other|||||||0.49|||||||Fisher Exact|||ETR: Group E versus Group F|
1736342|NCT00483938|3196743|Superiority or Other|||||||0.612|||||||Fisher Exact|||ETR: Group C versus Group D|
1736343|NCT00483938|3196743|Superiority or Other|||||||0.792|||||||Fisher Exact|||ETR: Group A versus Group B|
1736344|NCT00483938|3196744|Superiority or Other|||||||1|||||||Fisher Exact|||SVR: Group E versus Group F|
1736345|NCT00483938|3196744|Superiority or Other|||||||1|||||||Fisher Exact|||SVR: Group C versus Group D|
1736346|NCT00483938|3196745|Superiority or Other|||||||0.51|||||||Fisher Exact|||SVR: Group A versus Group B|
1736347|NCT00483704|3196774|Superiority or Other||Odds Ratio (OR)|3.02|||<|0.001|2-Sided|95.0|2.0|4.56|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736348|NCT00483704|3196774|Superiority or Other||Odds Ratio (OR)|2.32|||<|0.001|2-Sided|95.0|1.52|3.54|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736349|NCT00483704|3196775|Superiority or Other||Odds Ratio (OR)|2.81|||<|0.001|2-Sided|95.0|1.97|4.01|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736350|NCT00483704|3196775|Superiority or Other||Odds Ratio (OR)|2.36|||<|0.001|2-Sided|95.0|1.65|3.38|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736351|NCT00483704|3196776|Superiority or Other||Odds Ratio (OR)|3.37|||<|0.001|2-Sided|95.0|2.22|5.12|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736352|NCT00483704|3196776|Superiority or Other||Odds Ratio (OR)|2.4|||<|0.001|2-Sided|95.0|1.56|3.69|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736353|NCT00483704|3196777|Superiority or Other||Odds Ratio (OR)|3.45|||<|0.001|2-Sided|95.0|2.3|5.19|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736354|NCT00483704|3196777|Superiority or Other||Odds Ratio (OR)|2.69|||<|0.001|2-Sided|95.0|1.78|4.07|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736355|NCT00483704|3196780|Superiority or Other||Odds Ratio (OR)|1.57|||<|0.001|2-Sided|95.0|1.21|2.04|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736356|NCT00483704|3196780|Superiority or Other||Odds Ratio (OR)|1.67|||<|0.001|2-Sided|95.0|1.28|2.17|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736357|NCT00483704|3196781|Superiority or Other||Odds Ratio (OR)|1.61|||<|0.001|2-Sided|95.0|1.26|2.06|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736358|NCT00483704|3196781|Superiority or Other||Odds Ratio (OR)|1.74|||<|0.001|2-Sided|95.0|1.36|2.22|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736359|NCT00483704|3196782|Superiority or Other||Odds Ratio (OR)|1.67|||<|0.001|2-Sided|95.0|1.31|2.14|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736360|NCT00483704|3196782|Superiority or Other||Odds Ratio (OR)|1.65|||<|0.001|2-Sided|95.0|1.3|2.11|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736361|NCT00483704|3196783|Superiority or Other||Odds Ratio (OR)|3.23|||<|0.001|2-Sided|95.0|2.41|4.34|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736362|NCT00483704|3196783|Superiority or Other||Odds Ratio (OR)|2.62|||<|0.001|2-Sided|95.0|1.96|3.51|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736363|NCT00483704|3196784|Superiority or Other||Odds Ratio (OR)|6.18|||<|0.001|2-Sided|95.0|3.36|11.39|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736364|NCT00483704|3196784|Superiority or Other||Odds Ratio (OR)|3.85|||<|0.001|2-Sided|95.0|2.05|7.23|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736365|NCT00483704|3196785|Superiority or Other||Odds Ratio (OR)|2.8|||<|0.001|2-Sided|95.0|2.17|3.61|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736366|NCT00483704|3196785|Superiority or Other||Odds Ratio (OR)|3.03|||<|0.001|2-Sided|95.0|2.35|3.9|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736367|NCT00483704|3196786|Superiority or Other||Odds Ratio (OR)|3.03|||<|0.001|2-Sided|95.0|2.15|4.27|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736368|NCT00483704|3196786|Superiority or Other||Odds Ratio (OR)|2.54|||<|0.001|2-Sided|95.0|1.8|3.58|||Regression, Logistic|Computed using a logistic regression model adjusting for geographic region, baseline migraine severity, and age.|An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1736369|NCT00483548|3196793|Superiority or Other||Least squares mean|0.09|Standard Error of the Mean|0.14||0.536||95.0|-0.19|0.36|||ANCOVA|||Overall life satisfaction: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736370|NCT00483548|3196793|Superiority or Other||Least squares mean|-0.09|Standard Error of the Mean|0.13||0.5238||95.0|-0.35|0.18|||ANCOVA|||Medications: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736371|NCT00483548|3196793|Superiority or Other||Least squares mean|1.52|Standard Error of the Mean|2.54||0.5519||95.0|-3.5|6.53|||ANCOVA|||Total Q-LES-Q: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736372|NCT00483548|3196794|Superiority or Other||Least squares mean|0.0|Standard Error of the Mean|0.02||0.9864||95.0|-0.04|0.04|||ANCOVA|||Incapacitation score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736373|NCT00483548|3196794|Superiority or Other||Least squares mean|0.0|Standard Error of the Mean|0.01||0.9097||95.0|-0.03|0.03|||ANCOVA|||Incapacitation score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736374|NCT00483548|3196794|Superiority or Other||Least squares mean|0.02|Standard Error of the Mean|0.02||0.3278||95.0|-0.02|0.05|||ANCOVA|||Incapacitation score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736375|NCT00483548|3196794|Superiority or Other||Least squares mean|0.01|Standard Error of the Mean|0.03||0.7455||95.0|-0.05|0.06|||ANCOVA|||Global severity score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736376|NCT00483548|3196794|Superiority or Other||Least squares mean|0.01|Standard Error of the Mean|0.02||0.5779||95.0|-0.04|0.06|||ANCOVA|||Global severity score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736401|NCT00483548|3196802|Superiority or Other||Least squares mean|-0.01|Standard Error of the Mean|0.15||0.9518||95.0|-0.31|0.29|||ANOVA|||Week 5; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.|
1736377|NCT00483548|3196794|Superiority or Other||Least squares mean|0.05|Standard Error of the Mean|0.03||0.0844||95.0|-0.01|0.1|||ANCOVA|||Global severity score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736378|NCT00483548|3196794|Superiority or Other||Least squares mean|0.0|Standard Error of the Mean|0.04||0.9574||95.0|-0.08|0.08|||ANCOVA|||Total score: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736379|NCT00483548|3196794|Superiority or Other||Least squares mean|-0.01|Standard Error of the Mean|0.03||0.7462||95.0|-0.07|0.05|||ANCOVA|||Total score: Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736380|NCT00483548|3196794|Superiority or Other||Least squares mean|0.11|Standard Error of the Mean|0.05||0.0271||95.0|0.01|0.21|||ANCOVA|||Total score: Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736381|NCT00483548|3196795|Superiority or Other||Least squares mean|0.07|Standard Error of the Mean|0.06||0.2613||95.0|-0.05|0.19|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736382|NCT00483548|3196795|Superiority or Other||Least squares mean|0.04|Standard Error of the Mean|0.06||0.4745||0.16|-0.07|0.16|||ANCOVA|||Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736383|NCT00483548|3196795|Superiority or Other||Least squares mean|0.12|Standard Error of the Mean|0.05||0.0193||95.0|0.02|0.23|||ANCOVA|||Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736384|NCT00483548|3196796|Superiority or Other||Least squares mean|0.16|Standard Error of the Mean|0.07||0.0226||95.0|0.02|0.29|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736385|NCT00483548|3196796|Superiority or Other||Least squares mean|0.02|Standard Error of the Mean|0.07||0.8134||95.0|-0.13|0.16|||ANCOVA|||Week 4; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736386|NCT00483548|3196796|Superiority or Other||Least squares mean|0.17|Standard Error of the Mean|0.07||0.0096||95.0|0.04|0.31|||ANCOVA|||Week 2; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736387|NCT00483548|3196797|Superiority or Other||Least squares mean|-0.17|Standard Error of the Mean|0.34||0.6232|2-Sided|95.0|-0.84|0.5|||ANCOVA|||Days Unproductive: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736388|NCT00483548|3196797|Superiority or Other||Least squares mean|-0.44|Standard Error of the Mean|0.28||0.123|2-Sided|95.0|-1.0|0.12|||ANCOVA|||Days Lost: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736389|NCT00483548|3196798|Superiority or Other||Least squares mean|-4.56|Standard Error of the Mean|1.35||0.001||95.0|-7.24|-1.87|||ANCOVA|||Total SDS: Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736390|NCT00483548|3196799|Superiority or Other||Least squares mean|4.24|Standard Error of the Mean|1.65||0.0108||95.0|0.99|7.5|||ANCOVA|||Week 6; Observed cases; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736391|NCT00483548|3196800|Superiority or Other||Least squares mean|0.19|Standard Error of the Mean|0.65||0.7647||95.0|-1.08|1.46|||ANCOVA|||Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736392|NCT00483548|3196800|Superiority or Other||Least squares mean|0.5|Standard Error of the Mean|0.59||0.3993||95.0|-0.67|1.67|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736393|NCT00483548|3196800|Superiority or Other||Least squares mean|0.43|Standard Error of the Mean|0.59||0.4646||95.0|-0.73|1.59|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736394|NCT00483548|3196800|Superiority or Other||Least squares mean|0.13|Standard Error of the Mean|0.6||0.8337||95.0|-1.05|1.3|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736395|NCT00483548|3196800|Superiority or Other||Least squares mean|0.64|Standard Error of the Mean|0.53||0.2345||95.0|-0.41|1.68|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736396|NCT00483548|3196800|Superiority or Other||Least squares mean|0.7|Standard Error of the Mean|0.46||0.1277||95.0|-0.2|1.6|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736397|NCT00483548|3196801|Superiority or Other||Least squares mean|0.61|Standard Error of the Mean|0.86||0.477||95.0|-1.08|2.3|||ANCOVA|||Week 6; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736398|NCT00483548|3196801|Superiority or Other||Least squares mean|0.59|Standard Error of the Mean|0.8||0.4565||95.0|-0.98|2.17|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736399|NCT00483548|3196801|Superiority or Other||Least squares mean|0.35|Standard Error of the Mean|0.75||0.6362||95.0|-1.12|1.82|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736400|NCT00483548|3196802|Superiority or Other||Least squares mean|0.11|Standard Error of the Mean|0.16||0.4757||95.0|-0.2|0.42||Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.|ANOVA|||Week 6; LOCF|
1736402|NCT00483548|3196802|Superiority or Other||Least squares mean|-0.06|Standard Error of the Mean|0.15||0.7062||95.0|-0.34|0.23|||ANOVA|||Week 4; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.|
1736403|NCT00483548|3196802|Superiority or Other||Least squares mean|0.0|Standard Error of the Mean|0.13||0.9835||95.0|-0.26|0.26|||ANOVA|||Week 3; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.|
1736404|NCT00483548|3196802|Superiority or Other||Least squares mean|-0.14|Standard Error of the Mean|0.13||0.2803||95.0|-0.38|0.11|||ANOVA|||Week 2; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.|
1736405|NCT00483548|3196802|Superiority or Other||Least squares mean|-0.22|Standard Error of the Mean|0.11||0.0392||95.0|-0.43|-0.01|||ANOVA|||Week 1; LOCF; Analysis of variance model with treatment, country, type of mood stabilizer as fixed effects.|
1736406|NCT00483548|3196803|Superiority or Other||Least squares mean|-0.04|Standard Error of the Mean|0.13||0.7907||95.0|-0.3|0.23|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736407|NCT00483548|3196803|Superiority or Other||Least squares mean|0.0|Standard Error of the Mean|0.12||0.977||95.0|-0.24|0.25|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736408|NCT00483548|3196803|Superiority or Other||Least squares mean|-0.05|Standard Error of the Mean|0.11||0.6765||95.0|-0.27|0.18|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736409|NCT00483548|3196803|Superiority or Other||Least squares mean|-0.15|Standard Error of the Mean|0.11||0.1765||95.0|-0.37|0.07|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736410|NCT00483548|3196803|Superiority or Other||Least squares mean|-0.12|Standard Error of the Mean|0.09||0.1771||95.0|-0.29|0.05|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736411|NCT00483548|3196804|Superiority or Other||Least squares mean|-0.25|Standard Error of the Mean|1.19||0.8322||95.0|-2.6|2.1|||ANCOVA|||Week 5; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736412|NCT00483548|3196804|Superiority or Other||Least squares mean|-0.68|Standard Error of the Mean|1.12||0.5485||95.0|-2.89|1.54|||ANCOVA|||Week 4; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736413|NCT00483548|3196804|Superiority or Other||Least squares mean|-0.43|Standard Error of the Mean|1.09||0.6971||95.0|-2.57|1.72|||ANCOVA|||Week 3; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736414|NCT00483548|3196804|Superiority or Other||Least squares mean|-1.25|Standard Error of the Mean|1.03||0.223||95.0|-3.27|0.77|||ANCOVA|||Week 2; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736415|NCT00483548|3196804|Superiority or Other||Least squares mean|-1.68|Standard Error of the Mean|0.89||0.0594||95.0|-3.42|0.07|||ANCOVA|||Week 1; LOCF; Analysis of covariance model with treatment, country, type of mood stabilizer as fixed effects and baseline score as covariate.|
1736416|NCT00483548|3196805|Superiority or Other||Odds Ratio (OR)|0.939||||0.7924||95.0|0.59|1.5||Logistic regression model with treatment, country, and type of mood stabilizer.|Regression, Logistic|||Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.|
1736417|NCT00483548|3196806|Superiority or Other||Odds Ratio (OR)|0.949||||0.8266||95.0|0.59|1.52|||Regression, Logistic||Odds ratio measures the odds of achieving response (≥ 50 % reduction in MADRS total score) from ziprasidone treated subjects versus placebo; a value > 1 favors ziprasidone.|Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.|
1736418|NCT00483548|3196807|Superiority or Other||Odds Ratio (OR)|0.846||||0.5029||95.0|0.52|1.38|||Regression, Logistic||Odds ratio measures the odds of achieving remission (MADRS total score ≤ 12) from ziprasidone treated subjects versus placebo; a value > 1 favors ziprasidone.|Week 6; LOCF; Logistic regression model with treatment, country, and type of mood stabilizer.|
1736419|NCT00483548|3196808|Superiority or Other||Least squares mean|0.06|Standard Error of the Mean|0.16||0.7223||95.0|-0.25|0.36|||ANCOVA Mixed-effects repeated-measures|||Week 6; MMRM analysis of covariance model with fixed categorical effects of treatment, country, type of mood stabilizer, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.|
1736420|NCT00483548|3196809|Superiority or Other||Least squares mean|-0.36|Standard Error of the Mean|1.37||0.7921||95.0|-3.07|2.34||Due to planned interim analysis of primary endpoint, to control type I error at 2-sided alpha=0.05, a nominal 2-sided p-value ≤0.0476 needed at final analysis to reject the null hypothesis of no treatment effect.|ANCOVA Mixed-effects repeated-measures|No other adjustment made for multiple comparisons since all comparisons, except for single primary comparison, are considered secondary.|Mixed-effects repeated-measures (MMRM) analysis of covariance model: fixed categorical effects of treatment, country, mood stabilizer type, visit, treatment-by-visit interaction, fixed continuous effect of baseline value and subject as random effect.|N=141 per arm (282 total) needed for 85% power for 2-sided alpha=0.05 based on true mean difference=4.0 and standard deviation (SD)=11.0 for primary endpoint. Interim Analysis (IA) planned when 60% of subjects had completed study or discontinued prematurely to assess efficacy (nominal 2-sided p-value less than or equal to [≤] 0.0076) or futility (nominal 2-sided p-value greater than or equal to [≥] 0.5099).|
1736421|NCT00483262|3196841|Superiority or Other||response rate of PR or better|0.33|||||2-Sided|90.0|0.21|0.47|||||Response of PR or better|Phase II part of this phase I/II study.|
1736422|NCT00483262|3196841|Superiority or Other||response rate of PR or better|0.1|||||2-Sided|90.0|0.02|0.28|||||Response of PR or better|Phase I part of this phase I/II study|
1736423|NCT00483262|3196842|Superiority or Other||toxicity grade >=3 proportion|0.79|||||2-Sided|90.0|0.66|0.89|||||No comparison. Estimate the proportion of patients with grade 3 or higher toxicity.|Phase II toxicity|
1736454|NCT00482170|3196931|Superiority or Other|||||||0.004|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.|
1736424|NCT00483262|3196842|Superiority or Other||>= grade 3 adverse event proportion|0.9|||||2-Sided|90.0|0.72|0.98|||||Estimated proportion of patients with a adverse event of grade 3 or higher.|Single Arm Study|
1736425|NCT00483223|3196845|Other|||||||0.54|||||||t-test, 2 sided|||H0: no association between expression ratio and response rate Ha: Participants with expression ratio greater than 2 would have higher response rate|
1736426|NCT00483184|3196848|Superiority or Other|||||||0.404|||||||ANOVA|||Results were expressed as mean or number. Normal distributed data among the treatment groups were compared by One-way ANOVA test, non-normal distributed data were compared by Kruskal Wallis test, and then Bonferroni post-hoc test was used for multiple comparisons. Differences from baseline within treatment groups were evaluated by repeated measures ANOVA test for normal distributed data, Freidman test for non-normal distributed data.|
1736427|NCT00482729|3196874|Superiority or Other||Odds Ratio (OR)|2.11||||||95.0|1.63|2.73|||||This parameter estimate and 95% confidence interval correspond to the odds of having A1C <7.0% at Week 44 in the Sita/Met FDC group vs. the Metformin group, based on a logistic regression model with terms for treatment and baseline (i.e., Week 0) A1C||
1736428|NCT00482729|3196875|Superiority or Other||Mean Difference (Net)|-0.48||||||95.0|-0.67|-0.3|||||This is a difference in least squares means, based on an ANCOVA model with terms for treatment and baseline (i.e., Week 0) A1C.||
1736429|NCT00482729|3196876|Superiority or Other||Mean Difference (Net)|-15.7|||<|0.001||95.0|-22.4|-9.0|||ANCOVA|Model terms: treatment, baseline A1C|||
1736430|NCT00482729|3196877|Superiority or Other||Odds Ratio (OR)|2.07|||<|0.001||95.0|1.6|2.69||Based on a test of the odds ratio = 1, comparing the odds of having A1C <7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.|ANCOVA|Model terms: treatment, baseline A1C|This parameter estimate and 95% confidence interval correspond to the odds of having A1C <7.0% at Week 18 in the Sita/Met FDC group vs. the Metformin group.||
1736431|NCT00482729|3196878|Superiority or Other||Mean Difference (Net)|-0.6|||<|0.001||95.0|-0.78|-0.43|||ANCOVA|Model terms: treatment, baseline A1C|||
1736432|NCT00482612|3196907|Superiority or Other||||||<|0.0001|||||||ANCOVA|Baseline SL was used as a covariate.|||
1736433|NCT00482612|3196907|Superiority or Other||||||<|0.0135|||||||ANCOVA|Baseline SL was used as a covariate.|||
1736434|NCT00482612|3196907|Superiority or Other||||||<|0.0014|||||||ANCOVA|Baseline SL was used as a covariate.|||
1736435|NCT00482612|3196908|Superiority or Other||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.|||
1736436|NCT00482612|3196908|Superiority or Other||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.|||
1736437|NCT00482612|3196908|Superiority or Other||||||<|0.0001|||||||ANCOVA|Baseline TST was used as a covariate.|||
1736438|NCT00482170|3196924|Superiority or Other|||||||0.535|||||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.|
1736439|NCT00482170|3196925|Superiority or Other|||||||0.166|||||||Chi-squared|||p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg prefilled syringe group was calculated.|
1736440|NCT00482170|3196925|Superiority or Other|||||||0.098|||||||Chi-squared|||p-value for statistical difference between categories, very satisfied: alcohol usage- yes, very satisfied: alcohol usage- no, satisfied: alcohol usage- yes, satisfied: alcohol usage- no, less satisfied: alcohol usage- yes and less satisfied: alcohol usage- no, in the etanercept 50 mg auto-injector group was calculated.|
1736441|NCT00482170|3196925|Superiority or Other|||||||0.379|||||||Chi-squared|||p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg prefilled syringe group was calculated.|
1736442|NCT00482170|3196925|Superiority or Other|||||||0.787|||||||Chi-squared|||p-value for statistical difference between categories, very satisfied: tobacco usage- yes, very satisfied: tobacco usage- no, satisfied: tobacco usage- yes, satisfied: tobacco usage- no, less satisfied: tobacco usage- yes and less satisfied: tobacco usage- no, in the etanercept 50 mg auto-injector group was calculated.|
1736443|NCT00482170|3196926|Superiority or Other|||||||0.947|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.|
1736444|NCT00482170|3196926|Superiority or Other|||||||0.444|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.|
1736445|NCT00482170|3196927|Superiority or Other|||||||0.782|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.|
1736446|NCT00482170|3196927|Superiority or Other|||||||0.494|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.|
1736447|NCT00482170|3196928|Superiority or Other|||||||0.089|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.|
1736448|NCT00482170|3196928|Superiority or Other|||||||0.023|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.|
1736449|NCT00482170|3196929|Superiority or Other|||||||0.474|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.|
1736450|NCT00482170|3196929|Superiority or Other|||||||0.56|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.|
1736451|NCT00482170|3196930|Superiority or Other|||||||0.024|||||||Kruskal-Wallis|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.|
1736452|NCT00482170|3196930|Superiority or Other|||||||0.652|||||||Kruskal-Wallis|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.|
1736453|NCT00482170|3196931|Superiority or Other|||||||0.024|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.|
1738475|NCT00457197|3200384|Superiority or Other|||||||0.7222|||||||ANCOVA|||Baseline AST used as covariate.|
1736455|NCT00482170|3196932|Superiority or Other|||||||0.159|||||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.|
1736456|NCT00482170|3196932|Superiority or Other|||||||0.697|||||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.|
1736457|NCT00482170|3196933|Superiority or Other|||||||0.7|||||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.|
1736458|NCT00482170|3196933|Superiority or Other|||||||0.752|||||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.|
1736459|NCT00482170|3196934|Superiority or Other|||||||0.006|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.|
1736460|NCT00482170|3196934|Superiority or Other|||||||0.039|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.|
1736461|NCT00482170|3196935|Superiority or Other|||||||0.005|||||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg prefilled syringe group was calculated.|
1736462|NCT00482170|3196935|Superiority or Other|||||||0.411|||||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-D, satisfied: HAD-D and less satisfied: HAD-D, in the etanercept 50 mg auto-injector group was calculated.|
1736463|NCT00482170|3196935|Superiority or Other|||||||0.005|||||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg prefilled syringe group was calculated.|
1736464|NCT00482170|3196935|Superiority or Other|||||||0.029|||||||Kruskal-Wallis|||p-value for statistical difference between categories, very satisfied: HAD-A, satisfied: HAD-A and less satisfied: HAD-A, in the etanercept 50 mg auto-injector group was calculated.|
1736465|NCT00482170|3196936|Superiority or Other|||||||0.808|||||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.|
1736466|NCT00482170|3196936|Superiority or Other|||||||0.158|||||||Fisher Exact|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.|
1736467|NCT00482170|3196937|Superiority or Other|||||||0.549|||||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated.|
1736468|NCT00482170|3196937|Superiority or Other|||||||0.984|||||||Chi-squared|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated.|
1736469|NCT00482170|3196938|Superiority or Other|||||||0.01|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg prefilled syringe group was calculated using ANOVA.|
1736470|NCT00482170|3196938|Superiority or Other|||||||0.03|||||||ANOVA|||p-value for statistical difference between all categories in the etanercept 50 mg auto-injector group was calculated using ANOVA.|
1736471|NCT00482170|3196939|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.32||0.974|2-Sided|95.0|-0.62|0.64||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Last observation: ANOVA method was used for the analysis.|
1736472|NCT00482170|3196939|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.33||0.928|2-Sided|95.0|-0.67|0.61||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Week 12: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.|
1736473|NCT00482170|3196939|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.34||0.842|2-Sided|95.0|-0.74|0.6||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Week 4: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.|
1736474|NCT00482170|3196939|Superiority or Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.35||0.515|2-Sided|95.0|-0.91|0.46||Statistical testing, 2-sided, was done at 5% significance level.|ANOVA|||Baseline- after the training: Mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an auto-regressive correlation structure was used to calculate 95% CI.|
1736475|NCT00482170|3196940|Superiority or Other||Odds Ratio (OR)|0.8||||0.212|2-Sided|95.0|0.56|1.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736476|NCT00482170|3196940|Superiority or Other||Odds Ratio (OR)|0.79||||0.197|2-Sided|95.0|0.55|1.13||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736477|NCT00482170|3196940|Superiority or Other||Odds Ratio (OR)|0.83||||0.325|2-Sided|95.0|0.57|1.2||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736478|NCT00482170|3196940|Superiority or Other||Odds Ratio (OR)|0.87||||0.47|2-Sided|95.0|0.6|1.26||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the first injection: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736595|NCT00481247|3197061|Superiority or Other|||||||0.0056||||||A priori threshold for statistical significance=0.05.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by Hasford Score.|||
1736479|NCT00482170|3196941|Superiority or Other||Odds Ratio (OR)|0.41|||<|0.001|2-Sided|95.0|0.28|0.58||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736480|NCT00482170|3196941|Superiority or Other||Odds Ratio (OR)|0.38|||<|0.001|2-Sided|95.0|0.26|0.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736481|NCT00482170|3196941|Superiority or Other||Odds Ratio (OR)|0.32|||<|0.001|2-Sided|95.0|0.22|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736482|NCT00482170|3196941|Superiority or Other||Odds Ratio (OR)|0.33|||<|0.001|2-Sided|95.0|0.24|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736483|NCT00482170|3196942|Superiority or Other||Odds Ratio (OR)|0.35|||<|0.001|2-Sided|95.0|0.24|0.5||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736484|NCT00482170|3196942|Superiority or Other||Odds Ratio (OR)|0.34|||<|0.001|2-Sided|95.0|0.24|0.5||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736485|NCT00482170|3196942|Superiority or Other||Odds Ratio (OR)|0.31|||<|0.001|2-Sided|95.0|0.21|0.46||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736486|NCT00482170|3196942|Superiority or Other||Odds Ratio (OR)|0.38|||<|0.001|2-Sided|95.0|0.27|0.54||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736487|NCT00482170|3196943|Superiority or Other||Odds Ratio (OR)|0.32|||<|0.001|2-Sided|95.0|0.23|0.47||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736488|NCT00482170|3196943|Superiority or Other||Odds Ratio (OR)|0.31|||<|0.001|2-Sided|95.0|0.21|0.45||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736489|NCT00482170|3196943|Superiority or Other||Odds Ratio (OR)|0.26|||<|0.001|2-Sided|95.0|0.18|0.37||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736490|NCT00482170|3196943|Superiority or Other||Odds Ratio (OR)|0.34|||<|0.001|2-Sided|95.0|0.24|0.49||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736491|NCT00482170|3196944|Superiority or Other||Odds Ratio (OR)|1.59||||0.025|2-Sided|95.0|1.06|2.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736492|NCT00482170|3196944|Superiority or Other||Odds Ratio (OR)|1.61||||0.024|2-Sided|95.0|1.06|2.44||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736493|NCT00482170|3196944|Superiority or Other||Odds Ratio (OR)|1.33||||0.151|2-Sided|95.0|0.9|1.96||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736494|NCT00482170|3196944|Superiority or Other||Odds Ratio (OR)|1.44||||0.057|2-Sided|95.0|0.99|2.11||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736495|NCT00482170|3196945|Superiority or Other||Odds Ratio (OR)|2.27|||<|0.001|2-Sided|95.0|1.52|3.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736496|NCT00482170|3196945|Superiority or Other||Odds Ratio (OR)|2.13|||<|0.001|2-Sided|95.0|1.42|3.19||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736497|NCT00482170|3196945|Superiority or Other||Odds Ratio (OR)|2.63|||<|0.001|2-Sided|95.0|1.78|3.87||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736498|NCT00482170|3196945|Superiority or Other||Odds Ratio (OR)|1.93|||<|0.001|2-Sided|95.0|1.32|2.83||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736499|NCT00482170|3196946|Superiority or Other||Odds Ratio (OR)|1.45||||0.049|2-Sided|95.0|1.0|2.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736500|NCT00482170|3196946|Superiority or Other||Odds Ratio (OR)|1.4||||0.076|2-Sided|95.0|0.97|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736501|NCT00482170|3196946|Superiority or Other||Odds Ratio (OR)|1.68||||0.005|2-Sided|95.0|1.17|2.41||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736502|NCT00482170|3196946|Superiority or Other||Odds Ratio (OR)|1.53||||0.022|2-Sided|95.0|1.06|2.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736503|NCT00482170|3196947|Superiority or Other||Odds Ratio (OR)|1.53||||0.028|2-Sided|95.0|1.05|2.24||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736504|NCT00482170|3196947|Superiority or Other||Odds Ratio (OR)|1.51||||0.037|2-Sided|95.0|1.02|2.22||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736505|NCT00482170|3196947|Superiority or Other||Odds Ratio (OR)|1.31||||0.154|2-Sided|95.0|0.9|1.91||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736506|NCT00482170|3196947|Superiority or Other||Odds Ratio (OR)|1.36||||0.09|2-Sided|95.0|0.95|1.95||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736507|NCT00482170|3196948|Superiority or Other||Odds Ratio (OR)|0.93||||0.733|2-Sided|95.0|0.62|1.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736508|NCT00482170|3196948|Superiority or Other||Odds Ratio (OR)|0.93||||0.712|2-Sided|95.0|0.61|1.4||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736509|NCT00482170|3196948|Superiority or Other||Odds Ratio (OR)|1.05||||0.827|2-Sided|95.0|0.7|1.57||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736573|NCT00482170|3196968|Superiority or Other||Regression coefficient|0.09||||0.045|2-Sided|95.0|0.0|0.18||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.|
1736510|NCT00482170|3196948|Superiority or Other||Odds Ratio (OR)|1.02||||0.914|2-Sided|95.0|0.7|1.5||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736511|NCT00482170|3196949|Superiority or Other||Odds Ratio (OR)|0.79||||0.263|2-Sided|95.0|0.53|1.19||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736512|NCT00482170|3196949|Superiority or Other||Odds Ratio (OR)|0.77||||0.222|2-Sided|95.0|0.51|1.17||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736513|NCT00482170|3196949|Superiority or Other||Odds Ratio (OR)|0.77||||0.203|2-Sided|95.0|0.51|1.15||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736514|NCT00482170|3196949|Superiority or Other||Odds Ratio (OR)|0.91||||0.628|2-Sided|95.0|0.62|1.33||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736515|NCT00482170|3196950|Superiority or Other||Odds Ratio (OR)|0.68||||0.063|2-Sided|95.0|0.46|1.02||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736516|NCT00482170|3196950|Superiority or Other||Odds Ratio (OR)|0.69||||0.079|2-Sided|95.0|0.45|1.04||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736517|NCT00482170|3196950|Superiority or Other||Odds Ratio (OR)|0.65||||0.036|2-Sided|95.0|0.44|0.97||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736518|NCT00482170|3196950|Superiority or Other||Odds Ratio (OR)|0.88||||0.494|2-Sided|95.0|0.6|1.28||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736519|NCT00482170|3196951|Superiority or Other||Odds Ratio (OR)|1.24||||0.299|2-Sided|95.0|0.83|1.86||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736520|NCT00482170|3196951|Superiority or Other||Odds Ratio (OR)|1.21||||0.376|2-Sided|95.0|0.79|1.85||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736521|NCT00482170|3196951|Superiority or Other||Odds Ratio (OR)|1.24||||0.311|2-Sided|95.0|0.82|1.87||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736522|NCT00482170|3196951|Superiority or Other||Odds Ratio (OR)|1.38||||0.098|2-Sided|95.0|0.94|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736523|NCT00482170|3196952|Superiority or Other||Odds Ratio (OR)|0.75||||0.148|2-Sided|95.0|0.51|1.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736524|NCT00482170|3196952|Superiority or Other||Odds Ratio (OR)|0.81||||0.298|2-Sided|95.0|0.54|1.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736525|NCT00482170|3196952|Superiority or Other||Odds Ratio (OR)|0.73||||0.1|2-Sided|95.0|0.5|1.06||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736526|NCT00482170|3196952|Superiority or Other||Odds Ratio (OR)|0.72||||0.065|2-Sided|95.0|0.5|1.02||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736527|NCT00482170|3196953|Superiority or Other||Odds Ratio (OR)|1.22||||0.29|2-Sided|95.0|0.85|1.76||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736528|NCT00482170|3196953|Superiority or Other||Odds Ratio (OR)|1.31||||0.156|2-Sided|95.0|0.9|1.91||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736529|NCT00482170|3196953|Superiority or Other||Odds Ratio (OR)|1.07||||0.737|2-Sided|95.0|0.73|1.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736530|NCT00482170|3196953|Superiority or Other||Odds Ratio (OR)|1.18||||0.356|2-Sided|95.0|0.83|1.69||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736531|NCT00482170|3196954|Superiority or Other||Odds Ratio (OR)|1.36||||0.164|2-Sided|95.0|0.88|2.08||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736532|NCT00482170|3196954|Superiority or Other||Odds Ratio (OR)|1.45||||0.096|2-Sided|95.0|0.94|2.24||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736533|NCT00482170|3196954|Superiority or Other||Odds Ratio (OR)|1.37||||0.172|2-Sided|95.0|0.87|2.15||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736534|NCT00482170|3196954|Superiority or Other||Odds Ratio (OR)|1.04||||0.837|2-Sided|95.0|0.7|1.56||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736535|NCT00482170|3196955|Superiority or Other||Odds Ratio (OR)|1.04||||0.857|2-Sided|95.0|0.69|1.55||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736536|NCT00482170|3196955|Superiority or Other||Odds Ratio (OR)|1.18||||0.434|2-Sided|95.0|0.78|1.78||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736537|NCT00482170|3196955|Superiority or Other||Odds Ratio (OR)|1.32||||0.205|2-Sided|95.0|0.86|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736538|NCT00482170|3196955|Superiority or Other||Odds Ratio (OR)|0.7||||0.072|2-Sided|95.0|0.48|1.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736539|NCT00482170|3196956|Superiority or Other||Odds Ratio (OR)|0.85||||0.43|2-Sided|95.0|0.57|1.27||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736540|NCT00482170|3196956|Superiority or Other||Odds Ratio (OR)|0.9||||0.604|2-Sided|95.0|0.59|1.36||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736574|NCT00482170|3196969|Superiority or Other||Regression coefficient|0.02||||0.211|2-Sided|95.0|-0.01|0.04||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.|
1736541|NCT00482170|3196956|Superiority or Other||Odds Ratio (OR)|1.01||||0.947|2-Sided|95.0|0.67|1.54||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736542|NCT00482170|3196956|Superiority or Other||Odds Ratio (OR)|1.09||||0.681|2-Sided|95.0|0.73|1.62||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736543|NCT00482170|3196957|Superiority or Other||Odds Ratio (OR)|2.45|||<|0.001|2-Sided|95.0|1.55|3.86||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736544|NCT00482170|3196957|Superiority or Other||Odds Ratio (OR)|2.58|||<|0.001|2-Sided|95.0|1.62|4.12||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736545|NCT00482170|3196957|Superiority or Other||Odds Ratio (OR)|2.96|||<|0.001|2-Sided|95.0|1.83|4.77||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736546|NCT00482170|3196957|Superiority or Other||Odds Ratio (OR)|2.34|||<|0.001|2-Sided|95.0|1.5|3.65||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736547|NCT00482170|3196958|Superiority or Other||Odds Ratio (OR)|2.42|||<|0.001|2-Sided|95.0|1.64|3.59||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736548|NCT00482170|3196958|Superiority or Other||Odds Ratio (OR)|2.35|||<|0.001|2-Sided|95.0|1.58|3.51||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736549|NCT00482170|3196958|Superiority or Other||Odds Ratio (OR)|2.42|||<|0.001|2-Sided|95.0|1.62|3.62||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736550|NCT00482170|3196958|Superiority or Other||Odds Ratio (OR)|2.18|||<|0.001|2-Sided|95.0|1.48|3.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736551|NCT00482170|3196959|Superiority or Other||Odds Ratio (OR)|1.29||||0.249|2-Sided|95.0|0.84|2.0||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736552|NCT00482170|3196959|Superiority or Other||Odds Ratio (OR)|1.33||||0.22|2-Sided|95.0|0.84|2.08||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736553|NCT00482170|3196959|Superiority or Other||Odds Ratio (OR)|1.31||||0.227|2-Sided|95.0|0.85|2.03||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736554|NCT00482170|3196959|Superiority or Other||Odds Ratio (OR)|1.3||||0.21|2-Sided|95.0|0.86|1.94||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736555|NCT00482170|3196960|Superiority or Other||Odds Ratio (OR)|1.12||||0.625|2-Sided|95.0|0.71|1.79||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736575|NCT00482170|3196970|Superiority or Other||Regression coefficient|0.22||||0.17|2-Sided|95.0|-0.09|0.53||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 1 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.|
1736556|NCT00482170|3196960|Superiority or Other||Odds Ratio (OR)|1.22||||0.42|2-Sided|95.0|0.75|1.99||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736557|NCT00482170|3196960|Superiority or Other||Odds Ratio (OR)|1.02||||0.936|2-Sided|95.0|0.63|1.64||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736558|NCT00482170|3196960|Superiority or Other||Odds Ratio (OR)|1.68||||0.025|2-Sided|95.0|1.07|2.64||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736559|NCT00482170|3196961|Superiority or Other||Odds Ratio (OR)|2.06||||0.001|2-Sided|95.0|1.32|3.21||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736560|NCT00482170|3196961|Superiority or Other||Odds Ratio (OR)|2.34|||<|0.001|2-Sided|95.0|1.47|3.73||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736561|NCT00482170|3196961|Superiority or Other||Odds Ratio (OR)|1.73|||<|0.017|2-Sided|95.0|1.1|2.72||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736562|NCT00482170|3196961|Superiority or Other||Odds Ratio (OR)|1.88|||<|0.004|2-Sided|95.0|1.22|2.89||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736563|NCT00482170|3196962|Superiority or Other||Odds Ratio (OR)|2.51|||<|0.001|2-Sided|95.0|1.66|3.8||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used to analyze individual concepts and questions measuring participant perception.|
1736564|NCT00482170|3196962|Superiority or Other||Odds Ratio (OR)|2.74|||<|0.001|2-Sided|95.0|1.78|4.21||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736565|NCT00482170|3196962|Superiority or Other||Odds Ratio (OR)|2.43|||<|0.001|2-Sided|95.0|1.61|3.67||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4:A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736566|NCT00482170|3196962|Superiority or Other||Odds Ratio (OR)|2.39|||<|0.001|2-Sided|95.0|1.63|3.49||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Baseline- after the training: A GEE model, using a cumulative logit link, a multinomial distribution and an independent correlation structure, with device group, visit and the interaction between device group and visit as fixed factors, was used to analyze individual concepts and questions measuring participant perception.|
1736567|NCT00482170|3196963|Superiority or Other||Regression coefficient|0.09||||0.713|2-Sided|95.0|-0.37|0.55||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).|
1736568|NCT00482170|3196964|Superiority or Other||Regression coefficient|-0.73||||0.759|2-Sided|95.0|-5.37|3.92||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).|
1736569|NCT00482170|3196965|Superiority or Other||Regression coefficient|0.44||||0.061|2-Sided|95.0|-0.02|0.9||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, current alcohol usage: yes and current alcohol usage: no (reference).|
1736570|NCT00482170|3196965|Superiority or Other||Regression coefficient|-0.15||||0.531|2-Sided|95.0|-0.61|0.32||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, current tobacco usage: yes and current tobacco usage: no (reference).|
1736571|NCT00482170|3196966|Superiority or Other||Regression coefficient|0.0||||0.968|2-Sided|95.0|-0.17|0.17||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.|
1736572|NCT00482170|3196967|Superiority or Other||Regression coefficient|-0.01||||0.913|2-Sided|95.0|-0.12|0.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.|
1738476|NCT00457197|3200385|Superiority or Other|||||||0.9642|||||||ANCOVA|||Baseline GGT used as covariate.|
1736576|NCT00482170|3196971|Superiority or Other||Regression coefficient|0.02||||0.693|2-Sided|95.0|-0.08|0.12|||Regression, Linear|||Statistical analysis was carried out between all categories, by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.|
1736577|NCT00482170|3196972|Superiority or Other||Regression coefficient|-0.24||||0.359|2-Sided|95.0|-0.76|0.28||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, yes and no (reference).|
1736578|NCT00482170|3196973|Superiority or Other||Regression coefficient|0.13||||0.123|2-Sided|95.0|-0.04|0.3||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.|
1736579|NCT00482170|3196974|Superiority or Other||Regression coefficient|-0.16||||0.287|2-Sided|95.0|-0.46|0.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, HAD-D: =< 3, HAD-D: > 3 to 5, HAD-D: > 5 to 8 and HAD-A: > 8; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.|
1736580|NCT00482170|3196974|Superiority or Other||Regression coefficient|-0.09||||0.493|2-Sided|95.0|-0.36|0.17||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, HAD-A: =< 4, HAD-A: > 4 to 7, HAD-A: > 7 to 10 and HAD-A: > 10; by 5 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.|
1736581|NCT00482170|3196975|Superiority or Other||Regression coefficient|-0.55||||0.195|2-Sided|95.0|-1.21|0.11||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, university level and reading or writing capacity (reference).|
1736582|NCT00482170|3196975|Superiority or Other||Regression coefficient|-0.38||||0.195|2-Sided|95.0|-0.89|0.14||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, high school or baccalaureate level and reading or writing capacity (reference).|
1736583|NCT00482170|3196976|Superiority or Other||Regression coefficient|-0.09||||0.707|2-Sided|95.0|-0.58|0.39||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between categories, female and male (reference).|
1736584|NCT00482170|3196977|Superiority or Other||Regression coefficient|0.17||||0.045|2-Sided|95.0|0.0|0.34||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Linear|||Statistical analysis was carried out between all categories, by 10 unit increment. Univariate model in which all continuous variables were considered continuous and mean centered was used.|
1736585|NCT00482170|3196978|Superiority or Other||Odds Ratio (OR)|8.73|||<|0.001|2-Sided|95.0|2.59|29.47||Statistical testing, 2-sided, was done at 5% significance level.|Regression, Logistic|||Last observation: Logistic regression was used for the analysis.|
1736586|NCT00482170|3196978|Superiority or Other||Odds Ratio (OR)|7.88|||<|0.001|2-Sided|95.0|2.26|27.44||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 12: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.|
1736587|NCT00482170|3196978|Superiority or Other||Odds Ratio (OR)|11.25|||<|0.002|2-Sided|95.0|2.44|51.83||Statistical testing, 2-sided, was done at 5% significance level.|Generalized Estimating Equations|||Week 4: GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.|
1736588|NCT00482170|3196978|Superiority or Other||Odds Ratio (OR)|16.12|||<|0.008|2-Sided|95.0|2.05|126.9||Statistical testing, 2-sided, was done at 5% significance level.|Generalized estimating equations|||Baseline- after the training: Generalized Estimating Equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment group, visit and the interaction between treatment group and visit as fixed factors was used for the analysis.|
1736589|NCT00482170|3196979|Non-Inferiority or Equivalence|The non-inferiority test was performed using the 95% CI of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.|Mean Difference (Final Values)|1.41|Standard Error of the Mean|0.23|<|0.001|2-Sided|95.0|0.95|1.87||Statistical testing, one-sided, was done at 2.5% significance level.|ANOVA|||ANOVA using a mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.|
1736590|NCT00482170|3196980|Non-Inferiority or Equivalence|The non-inferiority test was performed using the 95 percent (%) confidence interval (CI) of the difference of mean participant satisfaction (alpha = 2.5%). Non-inferiority was demonstrated if the lower limit of the 2-sided CI is greater than -1.|Mean Difference (Final Values)|1.32|Standard Error of the Mean|0.23|<|0.001|2-Sided|95.0|0.87|1.77||Statistical testing, one-sided, was done at 2.5% significance level.|ANOVA|||Analysis of variance (ANOVA) using mixed linear model with participant as random effect, treatment group, visit and the interaction between treatment group and visit as fixed factors and with an unstructured correlation was used for the analysis.|
1736591|NCT00481507|3197045|Superiority or Other||Risk Ratio (RR)|0.82|||>|0.05|2-Sided|95.0|0.54|1.43||Reply: Only one test was performed for the primary outcome. No covariates were entered into this model and p-value is unadjusted.|Chi-squared|The results obtained from the logistic regression are equivalent to the chi-square test with one degree of freedom.||Reply: The null hypothesis was the rates of diarrhea for Kefir vs. Placebo are not different. Post power calculation was not performed because the difference observed (21.9% vs. 18%) was less than a difference that which would be considered clinically important.|
1736592|NCT00481247|3197057|Superiority or Other||Hazard Ratio (HR)|1.54|||||2-Sided|95.0|1.25|1.89||||||Hazard Ratio, and Confidence Interval were based on analyses on all randomized subjects|
1736593|NCT00481247|3197058|Superiority or Other||Hazard Ratio (HR)|1.46|||||2-Sided|95.0|1.2|1.77||||||Hazard Ratio and Confidence Interval were based on analyses on all randomized subjects|
1736594|NCT00481247|3197060|Superiority or Other||Hazard Ratio (HR)|0.79|||||2-Sided|95.0|0.55|1.13|||||||
1736600|NCT00481195|3197066|Superiority or Other|||||||0.9873|||||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment fro bipolar disorder|||
1736601|NCT00481195|3197067|Superiority or Other|||||||0.9768|||||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder|||
1736602|NCT00481195|3197068|Superiority or Other|||||||0.6631|||||||Cochran-Mantel-Haenszel|Adjusted for concurrent treatment for bipolar disorder.|||
1736603|NCT00481195|3197069|Superiority or Other|||||||0.6431|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736604|NCT00481195|3197070|Superiority or Other|||||||0.9007|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736605|NCT00481195|3197071|Superiority or Other|||||||0.7791|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736606|NCT00481195|3197072|Superiority or Other|||||||0.273|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736607|NCT00481195|3197073|Superiority or Other|||||||0.3463|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736608|NCT00481195|3197074|Superiority or Other|||||||0.5427|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736609|NCT00481195|3197075|Superiority or Other|||||||0.3712|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736610|NCT00481195|3197076|Superiority or Other|||||||0.0817|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736611|NCT00481195|3197077|Superiority or Other|||||||0.1869|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736612|NCT00481195|3197078|Superiority or Other|||||||0.1605|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736613|NCT00481195|3197079|Superiority or Other|||||||0.0968|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736614|NCT00481195|3197080|Superiority or Other|||||||0.8099|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736615|NCT00481195|3197081|Superiority or Other|||||||0.3814|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736616|NCT00481195|3197082|Superiority or Other|||||||0.0793|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736617|NCT00481195|3197083|Superiority or Other|||||||0.5389|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736618|NCT00481195|3197084|Superiority or Other|||||||0.0965|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736619|NCT00481195|3197085|Superiority or Other|||||||0.4428|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736620|NCT00481195|3197086|Superiority or Other|||||||0.9281|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736621|NCT00481195|3197087|Superiority or Other|||||||0.0862|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736622|NCT00481195|3197088|Superiority or Other|||||||0.2249|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736684|NCT00479882|3197204|Superiority or Other||Difference in Percentage|-0.3|||||2-Sided|95.0|-1.8|1.1|||||Wilson's Method|Period III|
1738517|NCT00457002|3200422|Superiority or Other||Risk Difference (RD)|0.14|||||2-Sided|95.0|-0.57|0.85|||||||
1736623|NCT00481195|3197089|Superiority or Other|||||||0.6737|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736624|NCT00481195|3197090|Superiority or Other|||||||0.1565|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736625|NCT00481195|3197091|Superiority or Other|||||||0.3129||||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel||||
1736626|NCT00481195|3197092|Superiority or Other|||||||0.2575||||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel||||
1736627|NCT00481195|3197093|Superiority or Other|||||||0.896||||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel||||
1736628|NCT00481195|3197094|Superiority or Other|||||||0.198||||||P-value is from a Cochran-Mantel-Haenzel chi-square test adjusted for concurrent treatment for bipolar disorder|Cochran-Mantel-Haenszel||||
1736629|NCT00481195|3197095|Superiority or Other|||||||0.0612|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736630|NCT00481195|3197096|Superiority or Other|||||||0.0502|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736631|NCT00481195|3197097|Superiority or Other|||||||0.2407|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736632|NCT00481195|3197098|Superiority or Other|||||||0.0802|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736633|NCT00481195|3197099|Superiority or Other|||||||0.0272|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736634|NCT00481195|3197100|Superiority or Other|||||||0.0795|||||||ANCOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an ANCOVA with treatment and concurrent treatment for bipolar disorder as factors, and the baseline value as covariate.|
1736635|NCT00481195|3197101|Superiority or Other|||||||0.0439|||||||ANOVA|||Least square (LS) mean and standard error of the LS mean for each treatment group and the p-value for the treatment comparison is from an analysis of variance (ANOVA) with treatment ands concurrent treatment for bipolar disorders as factors. A significant treatment-by baseline interaction was observed in the total score that violates the assumption of parallelism on which an ANCOVA is based, so the data was analyzed using ANOVA without baseline as a covariate rather than ANCOVA.|
1736636|NCT00480740|3197132|Non-Inferiority or Equivalence|Noninferiority of dexmedetomindine plus sevoflurane compared with the baseline (sevoflurane alone) for any given variable was reached when the difference (steady-state [dexmedetomidine + sevoflurane]-baseline [sevoflurane0]/baseline [sevoflurane]0 and its associated 95% confidence interval (CI) fell completely withing the range of +/-20% indicated by the gray column.||||||0.05||||||The original study design was powered to achieve at least 80% power to detect noninferiority with the two-tailed alpha level set at 0.05 for data with two measurements.|t-test, 2 sided||||
1736637|NCT00480493|3197141|Superiority or Other||Mean Difference (Final Values)|-2.48|Standard Error of the Mean|3.12||0.43|2-Sided|95.0|-8.76|3.8|||t-test, 2 sided||We also used a random-effect, mixed regression models to look for between group changes over time.|The difference in the Worry score at 12 months was compared between the groups using a 2 sided t-test.|
1736638|NCT00480493|3197142|Superiority or Other||Mean Difference (Final Values)|4.82|Standard Error of the Mean|10.05||0.634|2-Sided|95.0|-15.47|25.11|||t-test, 2 sided||Concern scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.|A 2 sided t-test was used to determine if there were significant differences in Concern between the two groups at 12 months.|
1736639|NCT00480493|3197143|Superiority or Other||Mean Difference (Final Values)|2.46|Standard Error of the Mean|3.36||0.468|2-Sided|95.0|-4.32|9.24|||t-test, 2 sided||Confidence scores were also compared using random-effect, mixed regression models to determine whether changes over time differed significantly between groups.|A 2 sided t-test was used to determine if the change in Confidence score was significantly different between the groups.|
1736640|NCT00480077|3197157|Superiority|The primary end point of the study, all-cause death or hospitalization for heart failure, was analyzed on a time-to-first-event basis with the log-rank test. The hazard ratio (HR) associated with allocation to the access arm relative to control was estimated with corresponding 95% confidence interval (CI) by fitting a Cox proportional hazards model containing the treatment group as a categorical factor.||||||0.063|||||||Log Rank||||
1736641|NCT00480025|3197188|Superiority||Treatment Efficacy|0.97||||0.7572|2-Sided|95.0|0.797|1.179|||Regression, Cox|||Analysis compared DFS PYAR between groups for the period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 No-CT/TTP-R (PYAR1) divided by PYAR in Placebo No-CT/TTP-R (PYAR2) and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account weighing using randomization-minimization factors (RMF) as regressors.|
1736685|NCT00479882|3197204|Superiority or Other||Difference in Percentage|-0.2||||0.685|2-Sided|95.0|-1.2|0.8|||Fisher Exact||Wilson's Method|Periods I/II|
1736749|NCT00477685|3197388|Superiority or Other|||||||0.01|||||||t-test, 2 sided|||Null hypothesis: the postoperative intraocular pressure at 90 days equals the preoperative intraocular pressure at baseline.|
1736642|NCT00480025|3197189|Superiority||Treatment Efficacy|1.024||||0.7379|2-Sided|95.0|0.891|1.177|||Regression, Cox|||Analysis compared DFS PYAR between groups for period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 Total/TTP-R (PYAR1) divided by PYAR in Placebo Total/TTP-R (PYAR2), and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account stratification by previous CT vs. No-CT treatment and weighing using randomization-minimization factors (RMF) as regressors.|
1736643|NCT00479882|3197190|Superiority or Other||Difference in Least Squares Means|0.2||||0.879|2-Sided|95.0|-1.9|2.3|||ANOVA|Factors for treatment, country and gender|||
1736644|NCT00479882|3197190|Superiority or Other||Difference in Least Squares Mean|-0.4||||0.69|2-Sided|95.0|-2.3|1.5|||ANOVA|Factors for treatment, country and gender|||
1736645|NCT00479882|3197191|Superiority or Other||Difference in Least Squares Means|3.7||||0.004|2-Sided|95.0|1.2|6.1|||ANOVA|Factors for treatment, country and gender.|||
1736646|NCT00479882|3197191|Superiority or Other||Difference in Least Squares Means|1.0||||0.341|2-Sided|95.0|-1.1|3.1|||ANOVA|Factors for treatment, country and gender|||
1736647|NCT00479882|3197192|Superiority or Other||Difference in Percentage|-0.2|||||2-Sided|95.0|-0.9|0.5|||||Wilson’s Score Method|Periods I/II|
1736648|NCT00479882|3197192|Superiority or Other||Difference in Percentage|0.2|||||2-Sided|95.0|-0.5|0.9|||||Wilson’s Score Method|Periods I/II|
1736649|NCT00479882|3197195|Superiority or Other||Difference in Percentage|2.0|||||2-Sided|95.0|-0.8|5.0|||||Wilson’s Score Method|Period III|
1736650|NCT00479882|3197195|Superiority or Other||Difference in Percentage|1.6|||||2-Sided|95.0|-1.0|4.2|||||Wilson’s Score Method|Periods I/II|
1736651|NCT00479882|3197195|Superiority or Other||Difference in Percentage|2.3|||||2-Sided|95.0|-0.5|5.2|||||Wilson’s Score Method|Period III|
1736652|NCT00479882|3197195|Superiority or Other||Difference in Percentage|-0.2|||||2-Sided|95.0|-2.5|2.1|||||Wilson’s Score Method|Periods I/II|
1736653|NCT00479882|3197196|Superiority or Other||Difference in Percentage|-2.8|||||2-Sided|95.0|-8.9|3.4|||||Wilson’s Score Method|Period III|
1736654|NCT00479882|3197196|Superiority or Other||Difference in Percentage|0.1|||||2-Sided|95.0|-5.2|5.3|||||Wilson’s Score Method|Periods I/II|
1736655|NCT00479882|3197196|Superiority or Other||Difference in Percentage|-1.9|||||2-Sided|95.0|-8.1|4.3|||||Wilson’s Score Method|Period III|
1736656|NCT00479882|3197196|Superiority or Other||Difference in Percentage|-1.4|||||2-Sided|95.0|-6.6|3.8|||||Wilson’s Score Method|Periods I/II|
1736657|NCT00479882|3197197|Superiority or Other||Difference in Percentage|0.2|||||2-Sided|95.0|-0.6|1.3|||||Wilson's Method|Period III|
1736658|NCT00479882|3197197|Superiority or Other||Difference in Percentage|0.2|||||2-Sided|95.0|-0.5|0.9|||||Wilson's Method|Periods I/II|
1736659|NCT00479882|3197197|Superiority or Other||Difference in Percentage|0.2|||||2-Sided|95.0|-0.7|1.2|||||Wilson's Method|Period III|
1736660|NCT00479882|3197197|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|95.0|-0.6|0.6|||||Wilson's Method|Periods I/II|
1736661|NCT00479882|3197198|Superiority or Other||Difference in Percentage|-0.4|||||2-Sided|95.0|-1.9|1.0|||||Wilson's Method|Period III|
1736662|NCT00479882|3197198|Superiority or Other||Difference in Percentage|-0.5||||0.452|2-Sided|95.0|-1.6|0.5|||Fisher Exact||Wilson's Method|Periods I/II|
1736663|NCT00479882|3197198|Superiority or Other||Difference in Percentage|-0.3|||||2-Sided|95.0|-1.6|0.9|||||Wilson's Method|Period III|
1736664|NCT00479882|3197198|Superiority or Other||Difference in Percentage|-1.2||||0.02|2-Sided|95.0|-2.4|-0.2|||Fisher Exact||Wilson's Method|Periods I/II|
1736665|NCT00479882|3197199|Superiority or Other||Difference in Percentage|0.3|||||2-Sided|95.0|-1.0|1.6|||||Wilson's Method|Period III|
1736666|NCT00479882|3197199|Superiority or Other||Difference in Percentage|0.2||||0.685|2-Sided|95.0|-0.8|1.2|||Fisher Exact||Wilson's Method|Period I/II|
1736667|NCT00479882|3197199|Superiority or Other||Difference in Percentage|-0.3|||||2-Sided|95.0|-1.6|0.9|||||Wilson's Method|Period III|
1736668|NCT00479882|3197199|Superiority or Other||Difference in Percentage|-0.3||||0.449|2-Sided|95.0|-1.4|0.6|||Fisher Exact||Wilson's Method|Periods I/II|
1736669|NCT00479882|3197200|Superiority or Other||Difference in Percentage|-0.2||||0.497|2-Sided|95.0|-0.9|0.5|||Fisher Exact|||Periods I/II|
1736670|NCT00479882|3197201|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|95.0|-0.8|0.9|||||Wilson's Method|Period III|
1736671|NCT00479882|3197201|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|95.0|-0.6|0.7|||||Wilson's Method|Periods I/II|
1736672|NCT00479882|3197201|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|95.0|-0.9|0.8|||||Wilson's Method|Period III|
1736673|NCT00479882|3197201|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|95.0|-0.7|0.6|||||Wilson's Method|Periods I/II|
1736674|NCT00479882|3197202|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|95.0|-0.8|0.9|||||Wilson's Method|Period III|
1736675|NCT00479882|3197202|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|95.0|-0.6|0.7|||||Wilson's Method|Periods I/II|
1736676|NCT00479882|3197202|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|95.0|-0.9|0.8|||||Wilson's Method|Period III|
1736677|NCT00479882|3197202|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|95.0|-0.7|0.6|||||Wilson's Method|Periods I/II|
1736678|NCT00479882|3197203|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|95.0|-0.8|0.9|||||Wilson's Method|Period III|
1736679|NCT00479882|3197203|Superiority or Other||Difference in Percentage|0.2||||0.617|2-Sided|95.0|-0.6|1.1|||Fisher Exact||Wilson's Method|Periods I/II|
1736680|NCT00479882|3197203|Superiority or Other||Difference in Percentage|0.4|||||2-Sided|95.0|-0.5|1.5|||||Wilson's Method|Period III|
1736681|NCT00479882|3197203|Superiority or Other||Difference in Percentage|0.0|||||2-Sided|95.0|-0.7|0.6|||||Wilson's Method|Periods I/II|
1736682|NCT00479882|3197204|Superiority or Other||Difference in Percentage|0.2|||||2-Sided|95.0|-0.8|1.4|||||Wilson's Method|Period III|
1736683|NCT00479882|3197204|Superiority or Other||Difference in Percentage|-0.3||||0.753|2-Sided|95.0|-1.6|0.9|||Fisher Exact||Wilson's Method|Periods I/II|
1741669|NCT00432809|3203963|Superiority or Other||||||<|0.001|||||||ANOVA||||
1736686|NCT00479882|3197205|Non-Inferiority or Equivalence|Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.|Difference in Least Squares Mean|-0.8|||||2-Sided|95.0|-1.9|0.2|||||||
1736687|NCT00479882|3197205|Non-Inferiority or Equivalence|Clinical equivalence HDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±4%.|Difference in Least Squares Mean|-0.2|||||2-Sided|95.0|-1.4|1.0|||||||
1736688|NCT00479882|3197206|Non-Inferiority or Equivalence|Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.|Difference in Least Squares Mean|1.4|||||2-Sided|95.0|0.4|2.4|||||||
1736689|NCT00479882|3197206|Non-Inferiority or Equivalence|Clinical equivalence LDL-C reduction was established if the 95% CI for the difference between these two treatments in percent change from baseline in LDL-C fell within ±3%.|Difference in Least squares mean|2.4|||||2-Sided|95.0|1.3|3.4|||||||
1736690|NCT00479856|3197212|Superiority or Other||percentage of participants|33.3||||||95.0|7.5|70.1|||||||
1736691|NCT00479713|3197214|Superiority or Other||Mean Difference (Final Values)|-6.67||||0.172||95.0|-16.67|2.87|||Nonparametric ANOVA|ANOVA model based on Tukey’s normalized ranks with term for treatment, stratum, baseline (categorized based on quartiles) and center|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free CI based on Wilcoxon’s rank||
1736692|NCT00479713|3197215|Superiority or Other||Mean Difference (Final Values)|-8.11|Standard Error of the Mean|1.43|<=|0||95.0|-10.91|-5.3|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center|||
1736693|NCT00479713|3197216|Superiority or Other||Mean Difference (Final Values)|-6.25|Standard Error of the Mean|1.44|<=|0||95.0|-9.07|-3.43|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.|||
1736694|NCT00479713|3197217|Superiority or Other||Mean Difference (Final Values)|-9.59|Standard Error of the Mean|1.98|<=|0||95.0|-13.49|-5.69|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.|||
1736695|NCT00479713|3197218|Superiority or Other||Mean Difference (Final Values)|-9.41|Standard Error of the Mean|1.58|<=|0||95.0|-12.5|-6.31|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.|||
1736696|NCT00479713|3197219|Superiority or Other||Mean Difference (Final Values)|-0.92|Standard Error of the Mean|1.17||0.433||95.0|-3.21|1.38|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center.|||
1736697|NCT00479713|3197220|Superiority or Other||Median Difference (Final Values)|-5.06||||0.056||95.0|-9.56|-0.3|||Nonparametric ANOVA|ANOVA model based on Tukey’s normalized ranks with term for treatment, stratum, baseline (categorized based on quartiles) and center.|The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free Confidence Interval (CI) based on Wilcoxon’s rank.||
1736698|NCT00479713|3197221|Superiority or Other||Mean Difference (Final Values)|-7.2|Standard Error of the Mean|1.2|<=|0||95.0|-9.56|-4.84|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center|||
1736699|NCT00479713|3197222|Superiority or Other||Odds Ratio (OR)|2.8|||<=|0||95.0|1.8|4.4|||Regression, Logistic|Model terms: treatment, stratum and baseline LDL-C (continuous)||Percentage of Participants who Attained Target LDL-C Goal of < 70 mg/dL (1.81 mmol/L)|
1736700|NCT00479713|3197222|Superiority or Other||Odds Ratio (OR)|2.1|||<=|0||95.0|1.5|3.0|||Regression, Logistic|Model terms: treatment, stratum and baseline LDL-C (continuous)||Percentage of Participants who Attained Target LDL-C Goal of < 100 mg/dL (2.59 mmol/L)|
1736701|NCT00479713|3197223|Superiority or Other||Mean Difference (Final Values)|-10.72|Standard Error of the Mean|1.72|<=|0||95.0|-14.1|-7.33|||ANOVA|Model terms: treatment, stratum, baseline (categorized based on quartiles) and center|||
1736702|NCT00479466|3197233|Superiority or Other||Mean Difference (Final Values)|-60.8|||<|0.001|2-Sided|95.0|-82.7|-38.8|||ANCOVA||||
1736703|NCT00479466|3197233|Superiority or Other||Mean Difference (Final Values)|-101.6|||<|0.001|2-Sided|95.0|-124.2|-79.1|||ANCOVA||||
1736704|NCT00479466|3197233|Superiority or Other||Mean Difference (Final Values)|-87.4|||<|0.001|2-Sided|95.0|-109.4|-65.3|||ANCOVA||||
1736705|NCT00479466|3197233|Superiority or Other||Mean Difference (Final Values)|-70.0|||<|0.001|2-Sided|95.0|-91.8|-48.2|||ANCOVA||||
1736706|NCT00479466|3197233|Superiority or Other||Mean Difference (Final Values)|-56.8|||<|0.001|2-Sided|95.0|-79.4|-34.3|||ANCOVA||||
1736707|NCT00479466|3197234|Superiority or Other||Mean Difference (Final Values)|-1.32|||<|0.001|2-Sided|95.0|-1.7|-0.95|||ANCOVA||||
1736708|NCT00479466|3197234|Superiority or Other||Mean Difference (Final Values)|-2.06|||<|0.001|2-Sided|95.0|-2.45|-1.68|||ANCOVA||||
1736709|NCT00479466|3197234|Superiority or Other||Mean Difference (Final Values)|-1.69|||<|0.001|2-Sided|95.0|-2.07|-1.31|||ANCOVA||||
1736710|NCT00479466|3197234|Superiority or Other||Mean Difference (Final Values)|-1.53|||<|0.001|2-Sided|95.0|-1.91|-1.15|||ANCOVA||||
1736711|NCT00479466|3197234|Superiority or Other||Mean Difference (Final Values)|-1.15|||<|0.001|2-Sided|95.0|-1.53|-0.76|||ANCOVA||||
1736712|NCT00479466|3197235|Superiority or Other||Mean Difference (Final Values)|-35.5|||<|0.001|2-Sided|95.0|-48.6|-22.4|||ANCOVA||||
1736713|NCT00479466|3197235|Superiority or Other||Mean Difference (Final Values)|-61.2|||<|0.001|2-Sided|95.0|-74.6|-47.8|||ANCOVA||||
1736714|NCT00479466|3197235|Superiority or Other||Mean Difference (Final Values)|-51.1|||<|0.001|2-Sided|95.0|-64.3|-38.0|||ANCOVA||||
1736715|NCT00479466|3197235|Superiority or Other||Mean Difference (Final Values)|-46.6|||<|0.001|2-Sided|95.0|-59.7|-33.4|||ANCOVA||||
1736716|NCT00479466|3197235|Superiority or Other||Mean Difference (Final Values)|-30.6|||<|0.001|2-Sided|95.0|-44.0|-17.3|||ANCOVA||||
1736732|NCT00478881|3197294|Superiority or Other||Mean Difference (Final Values)|0.657||||0.8533||95.0|-6.335|7.65||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||Placebo- Vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.|
1736717|NCT00479401|3197251|Non-Inferiority or Equivalence|A non-inferiority hypothesis comparing pramipexole ER to pramipexole IR was to be tested using a non-inferiority margin of -3 points. The primary efficacy endpoint in UPDRS part II+III was the change from baseline (week 0) to week 33 on the UPDRS Parts II+III score combined. The statistical model was analysis of covariance, controlling for baseline UPDRS Part II+III. Fixed terms in the model were treatment, country, and UPDRS Part II+III score at baseline.|Mean Difference (Final Values)|-0.2|||||2-Sided|95.0|-2.2|1.7|||||PPX ER non−inferior to PPX IR, if the lower limit of the confidence interval for the difference is higher than the non−inferiority margin of −3|A non-inferiority hypothesis (H0: μER - μIR < -3 vs. H1: μER - μIR ≥ -3) comparing pramipexole ER to pramipexole IR was tested using a non-inferiority margin of -3 points.|
1736718|NCT00479388|3197252|Superiority or Other||Mean Difference (Final Values)|-15.4|||<=|0||95.0|-19.2|-11.7|||Repeated measures analysis|ANCOVA model based on Tukey’s normalized ranks with term for treatment, gender, concomitant statin group and Tukey's normal score of baseline.|||
1736719|NCT00479388|3197253|Superiority or Other||Mean Difference (Final Values)|15.6|Standard Error of the Mean|1.2|<=|0||95.0|13.4|17.9|||Repeated measures analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline HDL-C-by-time and concomitant statin group-by-time interaction.|||
1736720|NCT00479388|3197254|Superiority or Other||Median Difference (Final Values)|-4.5|Standard Error of the Mean|1.6||0.006||95.0|-7.7|-1.3|||Repeated measures analysis|Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time, baseline LDL-C-by-time and concomitant statin group-by-time interaction.|||
1736721|NCT00479336|3197256|Superiority or Other||Slope|-0.021|Standard Error of the Mean|0.02||0.3167|2-Sided|95.0|-0.061|0.02|||Regression, Linear|||A linear regression model using change in body weight from baseline at the final timepoint as the criterion variable and dose as the explanatory variable was fitted to the dataset. The null hypothesis of whether the regression coefficient is zero (analysis using t-statistics) was tested at a two-tailed significance level of 0.05, and estimated values for the slope and 95% confidence interval were calculated.|
1736722|NCT00479037|3197275|Superiority or Other||Mean Difference (Net)|138.5|||<|0.0001|2-Sided|95.0|94.8|191.8||P-value corresponding to the tests of treatment effect was adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.|
1736723|NCT00479037|3197276|Superiority or Other||Mean Difference (Net)|92.9|||<|0.0001|2-Sided|95.0|63.8|127.1||P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.|
1736724|NCT00479037|3197277|Superiority or Other||Mean Difference (Net)|360.3|||<|0.0001|2-Sided|95.0|256.5|494.3||P-values corresponding to the tests of treatment effect for the primary endpoints were adjusted using the Hochberg procedure.|ANCOVA|||The bone marker values were log-transformed for the primary analysis as they were heavily skewed. Changes in log-transformed bone marker values were analyzed using an analysis of covariance (ANCOVA) with treatment and center as fixed effects and the baseline bone marker value as a covariate. An F-test was used to test the effect of treatment and the least square means were computed to assess the clinical difference between treatment groups.|
1736725|NCT00478881|3197287|Superiority or Other||Mean Difference (Final Values)|-1.095||||0.5312||95.0|-4.533|2.342||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA|||ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.|
1736726|NCT00478881|3197288|Superiority or Other||Mean Difference (Final Values)|-0.823||||0.3248||95.0|-2.476|0.829||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.|
1736727|NCT00478881|3197289|Superiority or Other||Mean Difference (Final Values)|0.118||||0.4928||95.0|-0.22|0.456||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.|
1736728|NCT00478881|3197290|Superiority or Other||Mean Difference (Final Values)|0.721||||0.0609||95.0|-0.033|1.476||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.|
1736729|NCT00478881|3197291|Superiority or Other||Mean Difference (Final Values)|-8.195||||0.3289||95.0|-24.692|8.303||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.|
1736730|NCT00478881|3197292|Superiority or Other||Mean Difference (Final Values)|-12.374||||0.2348||95.0|-32.834|8.087||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||placebo - vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.|
1736731|NCT00478881|3197293|Superiority or Other||Mean Difference (Final Values)|-15.59||||0.1539||95.0|-37.057|5.876||P-values were reported as nominal values and without any adjustments for multiplicity.|ANCOVA||Placebo- Vardenafil|ANCOVA models used for the secondary efficacy variables were the models determined for the primary efficacy variable or co-primary efficacy variable depending on the type of variable.|
1741670|NCT00432809|3203964|Superiority or Other|||||||0.86|||||||Wilcoxon (Mann-Whitney)||||
1736733|NCT00478881|3197295|Superiority or Other||Mean Difference (Final Values)|0.668||||0.0575||95.0|-0.021|1.358||Bladder volume (mL) at first detrusor contraction tested first. If significant, the change in the average number of daily micturitions was to be tested using a P <0.05.|ANCOVA||Placebo - Vardenafil|Countries were pooled into 2 clusters, which allowed for testing of Treatment by Center interaction. An ANCOVA including Baseline (Visit 2) as a covariate with main effects for treatment and country (see pooling above) was used to test treatment difference for the primary variable and co-primary variable.|
1736734|NCT00478881|3197296|Superiority or Other||Mean Difference (Final Values)|-8.045||||0.5293||95.0|-33.194|17.104||Bladder volume (mL) at first detrusor contraction tested first. If significant, the change in the average number of daily micturitions was to be tested using a P<0.05.|ANCOVA||Placebo-Vardenafil|Countries were pooled into 2 clusters, which allowed for testing of Treatment by Center interaction. An ANCOVA including Baseline (Visit 2) as a covariate with main effects for treatment and country (see pooling above) was used to test treatment difference for the primary variable and co-primary variable.|
1736735|NCT00478556|3197317|Superiority or Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum test was used to assess differences in bowel opacification score between the two groups.|
1736736|NCT00478556|3197318|Superiority or Other||difference in proportions|62.0|||<|0.001|||||||Binomial test of proportion|tested if values were different from 50%||All individuals tasted both preparations and indicated preference. A binomial test of proportion was done to see if these values differed from 50%.|
1736737|NCT00478192|3197362|Superiority or Other|||||||0.079|||||||ANCOVA||||
1736738|NCT00478192|3197367|Superiority or Other||||||<|0.001||||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."|
1736739|NCT00478192|3197367|Superiority or Other||||||<|0.019||||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."|
1736740|NCT00478192|3197367|Superiority or Other||||||<|0.028||||||P-Values are not adjusted on the basis of multiple comparrisons|ANCOVA|||"Statistical Analysis applies to Change from Baseline."|
1736741|NCT00478023|3197377|Superiority or Other (legacy)||Least square mean difference|46.9|||<|0.0001||95.0|31.4|62.4||No multiplicity adjustment.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as a covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|Null hypothesis of no treatment difference.|
1736742|NCT00478023|3197377|Superiority or Other (legacy)||Least square mean difference|51.4|||<|0.0001||95.0|36.1|66.7||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA||Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.|
1736743|NCT00478023|3197377|Superiority or Other (legacy)||Least square mean difference|44.0|||<|0.0001||95.0|28.6|59.5||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariates.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.|
1736744|NCT00478023|3197377|Superiority or Other (legacy)||Least square mean difference|37.1|||<|0.0001||95.0|21.6|52.6||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 48 hours (SPID48). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID48.|
1736745|NCT00478023|3197378|Superiority or Other (legacy)||Least square mean difference|20.6|||<|0.0001||95.0|13.4|27.8||No multiplicity adjustment used.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|Null hypothesis of no treatment difference.|
1736746|NCT00478023|3197378|Superiority or Other (legacy)||Least square mean difference|23.3|||<|0.0001||95.0|16.3|30.4||Adjusted. The Hochberg procedure used for multiplicity comparisons.|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.|
1736747|NCT00478023|3197378|Superiority or Other (legacy)||Least square mean difference|20.8|||<|0.0001||95.0|13.7|28.0||Adjusted. The Hochberg procedure used for multiplicity comparisons|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.|
1736748|NCT00478023|3197378|Superiority or Other (legacy)||Least square mean difference|18.1|||<|0.0001||95.0|10.9|25.3||Adjusted. The Hochberg procedure used for multiplicity comparisons|ANCOVA|ANCOVA with treatment and centre as fixed effects and baseline pain as covariate.|Only pain intensity assessments collected prior to the first dose of any additional analgesic medication considered. Afterwards LOCF used.|The null hypothesis is that all CG5503 IR dose groups are equal to the placebo group based on the mean sum of pain intensity difference at 24 hours (SPID24). The alternative hypothesis is that at least one CG5503 IR dose group is different from the placebo group based on the mean SPID24.|
1736750|NCT00477607|3197395|Superiority or Other||Mean Difference (Final Values)|48.2|Standard Error of the Mean|32.7||0.15|2-Sided|95.0|-18.1|114.6|||t-test, 2 sided|||H0: mean(max dose arm 1) = mean(max dose arm 2)|
1736751|NCT00477607|3197396|Superiority or Other||Mean Difference (Final Values)|-0.195|Standard Error of the Mean|0.3999||0.63|2-Sided|95.0|-1.03|0.64|||t-test, 2 sided|||H0: mean (MDA arm 1) = mean (MDA Arm 2)|
1736752|NCT00477607|3197397|Superiority or Other||Odds Ratio (OR)|2.0||||0.89|2-Sided|95.0|0.4|11.4|||Fisher Exact|No adjustments. Right one-sided p-value.||H0: pr(Hearing loss arm 1) = pr(Hearing loss arm 2)|
1736753|NCT00477490|3197434|Superiority or Other||Odds Ratio (OR)|2.893|||<|0.0001|2-Sided|95.0|1.795|4.715||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.|
1736754|NCT00477490|3197434|Superiority or Other||Odds Ratio (OR)|1.296|||<|0.2662|2-Sided|95.0|0.821|2.05||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.|
1736755|NCT00477490|3197434|Superiority or Other||Odds Ratio (OR)|1.147|||<|0.5527|2-Sided|95.0|0.729|1.807||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.|||
1736756|NCT00477490|3197434|Superiority or Other||Odds Ratio (OR)|1.017|||<|0.942|2-Sided|95.0|0.647|1.598||The a priori statistically significant difference versus placebo is p≤0.05.|Regression, Logistic|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids|||
1736757|NCT00477490|3197435|Superiority or Other||Mean Difference (Final Values)|-0.613|||<|0.0001|2-Sided|95.0|-0.848|-0.378||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.|
1736758|NCT00477490|3197435|Superiority or Other||Mean Difference (Final Values)|-0.277|||<|0.0207|2-Sided|95.0|-0.511|-0.042||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.||The trial was to be declared positive only if in the 100 μg group, a statistically significant positive effect as compared to placebo on both co-primaries was demonstrated. And only then, the next higher dose group (i.e., 50 μg) could be claimed superior to placebo, if it showed a statistically significant improvement over placebo on both co-primaries.|
1736759|NCT00477490|3197435|Superiority or Other||Mean Difference (Final Values)|-0.12|||<|0.3104|2-Sided|95.0|-0.353|0.112||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.|||
1736760|NCT00477490|3197435|Superiority or Other||Mean Difference (Final Values)|0.01|||<|0.9303|2-Sided|95.0|-0.221|0.242||The a priori statistically significant difference versus placebo is p≤0.05.|ANCOVA|Treatment difference and 95% CI were adjusted for age, absence/presence of nocturnal polyuria, and baseline number of nocturnal voids.|||
1736761|NCT00477464|3197455|Superiority or Other||percentage of participants|59.0|||||2-Sided|95.0|44.2|72.4|||||The estimated value represents the percentage of participants who achieved a best overall response of complete response, partial response, or stable disease.||
1736762|NCT00477451|3197456|Superiority|||||||0.207|||||||t-test, 2 sided||||
1736763|NCT00477451|3197457|Superiority|||||||0.368|||||||Wilcoxon (Mann-Whitney)||||
1736764|NCT00477451|3197458|Superiority|||||||0.2|||||||Fisher Exact||||
1736765|NCT00477334|3197470|Superiority or Other||Cox Proportional Hazard|1.01||||0.9372|2-Sided|95.0|0.74|1.39|||Kaplan-Meier & Cox Regression||"Hazard ratio in time to healing=hazard rate of Famciclovir/hazard rate of Placebo.~Based on Cox proportional hazards model with treatment, pooled center and gender as explanatory variables."|Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study after 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status were censored at the time of the last clinical lesion observation.|
1736766|NCT00477334|3197470|Superiority or Other||Median Difference (Final Values)|0.26||||0.4161|2-Sided|95.0|-0.4|0.98|||Hodges-Lehman Shift Model||Difference in time to healing= time to healing for Famciclovir-time to healing for Placebo. Hodges-Lehman shift model is used to estimate the difference in treatment effect. P-value is from the Wilcoxon rank-sum test.|Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status are imputed according to the distribution of the time to healing among the subjects in the placebo group whose time to healing is greater than or equal to the observed discontinuation time. (Censor time)|
1736767|NCT00477165|3197516|Superiority or Other||Odds Ratio (OR)|0.91||||0.59|2-Sided|95.0|0.687|1.196||p<0.05 for statistical significance|t-test, 2 sided||Repeated-measures logistic regression model, assuming the citalopram effect builds linearly over time starting at week 3.|Null hypothesis: number of patients achieving adequate relief is the same in both Citalopram and Placebo groups|
1738128|NCT00463047|3199498|Superiority or Other||Mean Difference (Final Values)|0.49|Standard Error of the Mean|0.13|<|0.0001||95.0|0.39|0.58|||ANOVA||||
1736768|NCT00476996|3197524|Superiority||Weighted Difference|27.6|||<|0.0001|2-Sided|95.0|20.0|35.3|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy|
1736769|NCT00476996|3197524|Superiority||Weighted Difference|27.2|||<|0.0001|2-Sided|95.0|19.5|34.9|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy|
1736770|NCT00476996|3197524|Superiority||Weighted Difference|24.7|||<|0.0001|2-Sided|95.0|16.8|32.7|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy|
1736771|NCT00476996|3197524|Superiority||Weighted Difference|19.4|||<|0.0001|2-Sided|95.0|11.3|27.5|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy|
1736772|NCT00476996|3197525|Superiority||Weighted Difference|13.4|||<|0.0001|2-Sided|95.0|8.2|18.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy|
1736773|NCT00476996|3197525|Superiority||Weighted Difference|6.6|||<|0.0042|2-Sided|95.0|2.1|11.2|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy|
1736774|NCT00476996|3197525|Superiority||Weighted Difference|6.7|||<|0.0014|2-Sided|95.0|2.6|10.8|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy|
1736775|NCT00476996|3197525|Superiority||Weighted Difference|4.6|||<|0.0203|2-Sided|95.0|0.7|8.5|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy|
1736776|NCT00476996|3197526|Superiority||Weighted Difference|20.8|||<|0.0001|2-Sided|95.0|14.5|27.1|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy|
1736777|NCT00476996|3197526|Superiority||Weighted Difference|19.3|||<|0.0001|2-Sided|95.0|12.9|25.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy|
1736778|NCT00476996|3197526|Superiority||Weighted Difference|16.2|||<|0.0001|2-Sided|95.0|10.2|22.1|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy|
1736779|NCT00476996|3197526|Superiority||Weighted Difference|13.2|||<|0.0001|2-Sided|95.0|7.4|19.1|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy|
1736780|NCT00476996|3197527|Superiority||Odds Ratio (OR)|5.04|||<|0.0001|2-Sided|95.0|3.54|7.18|||Proportional Odds Analysis|||At Week 48, analysis was stratified by region and baseline DMARD therapy|
1736781|NCT00476996|3197527|Superiority||Odds Ratio (OR)|4.18|||<|0.0001|2-Sided|95.0|2.93|5.96|||Proportional Odds Analysis|||At Week 48, analysis was stratified by region and baseline DMARD therapy|
1736782|NCT00476996|3197527|Superiority||Odds Ratio (OR)|3.49|||<|0.0001|2-Sided|95.0|2.49|4.91|||Proportional Odds Analysis|||At Week 24, analysis was stratified by region and baseline DMARD therapy|
1736783|NCT00476996|3197527|Superiority||Odds Ratio (OR)|2.6|||<|0.0001|2-Sided|95.0|1.85|3.66|||Proportional Odds Analysis|||At Week 24, analysis was stratified by region and baseline DMARD therapy|
1736784|NCT00476996|3197528|Superiority||Adjusted Mean Difference|-1.2|||<|0.0001|2-Sided|95.0|-1.5|-0.9|||Analysis of Variance|||Week 48 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment|
1736785|NCT00476996|3197528|Superiority||Adjusted Mean Difference|-0.9|||<|0.0001|2-Sided|95.0|-1.2|-0.7|||Analysis of Variance|||Week 48 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment|
1736786|NCT00476996|3197528|Superiority||Adjusted Mean Difference|-0.9|||<|0.0001|2-Sided|95.0|-1.1|-0.6|||Analysis of Variance|||Week 24 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment|
1736787|NCT00476996|3197528|Superiority||Adjusted Mean Difference|-0.6|||<|0.0001|2-Sided|95.0|-0.8|-0.3|||Analysis of Variance|||Week 24 analysis using adjusted mean difference. Model contains region, baseline DMARD therapy, baseline DAS28 score and treatment|
1736788|NCT00476996|3197529|Superiority||Weighted Difference|10.5|||<|0.0001|2-Sided|95.0|6.2|14.7|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy|
1736789|NCT00476996|3197529|Superiority||Weighted Difference|10.5|||<|0.0001|2-Sided|95.0|6.2|14.8|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy|
1736790|NCT00476996|3197529|Superiority||Weighted Difference|4.3|||<|0.0134|2-Sided|95.0|0.9|7.8|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy|
1736791|NCT00476996|3197529|Superiority||Weighted Difference|4.2|||<|0.0175|2-Sided|95.0|0.7|7.6|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy|
1736792|NCT00476996|3197530|Superiority||Weighted Difference|3.6||||0.033|2-Sided|95.0|0.3|6.8|||Cochran-Mantel-Haenszel|||Analysis was stratified by region and baseline DMARD therapy|
1736793|NCT00476996|3197530|Superiority||Weighted Difference|2.1||||0.1885|2-Sided|95.0|-1.0|5.2|||Cochran-Mantel-Haenszel|||Analysis was stratified by region and baseline DMARD therapy|
1736794|NCT00476996|3197531|Superiority||Weighted Difference|30.3|||<|0.0001|2-Sided|95.0|22.8|37.7|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy|
1736795|NCT00476996|3197531|Superiority||Weighted Difference|29.1|||<|0.0001|2-Sided|95.0|21.6|36.6|||Cochran-Mantel-Haenszel|||At Week 48, analysis was stratified by region and baseline DMARD therapy|
1736796|NCT00476996|3197531|Superiority||Weighted Difference|25.2|||<|0.0001|2-Sided|95.0|17.7|32.7|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy|
1736797|NCT00476996|3197531|Superiority||Weighted Difference|20.4|||<|0.0001|2-Sided|95.0|12.8|27.9|||Cochran-Mantel-Haenszel|||At Week 24, analysis was stratified by region and baseline DMARD therapy|
1736798|NCT00476593|3197543|Superiority or Other|||||||0.024|||||||t-test, 2 sided|||Patient's healthy eyes were compared with sex and age matched healthy controls with Two Sample Student't t-test. Null hypothesis was that quiet, currently unaffected eyes of patients had same macular thickness as age and sex matched controls.|
1737309|NCT00471237|3198310|Superiority||Mean Difference (Net)|-1.33|Standard Error of the Mean|0.36||0|2-Sided|95.0|-2.04|-0.63|||ANOVA|||Total Hip aBMD, Month 12|
1736799|NCT00476593|3197543|Superiority or Other|||||||0.018||||||Hypothesis: the use of diclofenac/dexamethasone does not influence macular thickness in treated eyes compared with untreated eyes of same subject.|t-test, 2 sided|The possible effect of both anti-inflammatory medications was tested in relation to participants' age and gender||Subjects who received diclofenac or dexamethasone eye drops in one eye. Macular thickness in both were compared between same subjects' eyes after 3 day's treatment. Diclofenac and dexamethasone treated eyes were not compared with each other, but with the contralateral eye of same subject by a paired Student's t-test in each medication group|
1736800|NCT00476242|3197546|Superiority or Other|||||||0.047|||||||Log Rank||||
1736801|NCT00476151|3197549|Superiority or Other|||||||0.083|||||||ANCOVA||||
1736802|NCT00475982|3197572|Superiority||Mean Difference (Net)|1.34||||0.063|2-Sided|95.0|-0.08|2.75|||paired t-test|||analysis between the two arms|
1736803|NCT00475982|3197572|Superiority|||||||0.207|||||||paired t-test|||intra-analysis within the control arm|
1736804|NCT00475982|3197572|Superiority|||||||0.073|||||||paired t-test|||intra-analysis within the weight loss arm|
1736805|NCT00475982|3197573|Superiority||Mean Difference (Net)|2.11||||0.007|2-Sided|95.0|0.64|3.59|||paired t-test|||analysis between the two arms|
1736806|NCT00475982|3197573|Superiority|||||||0.009|||||||paired t-test|||intra-analysis within the control arm|
1736807|NCT00475982|3197573|Superiority|||||||0|||||||paired t-test|||intra-analysis within the weight loss arm|
1736808|NCT00475982|3197574|Superiority||Mean Difference (Net)|0.77||||0.835|2-Sided|95.0|-6.7|8.24|||paired t-test|||analysis between the intervention and control arms|
1736809|NCT00475982|3197574|Superiority|||||||0.701|||||||paired t-test|||intra-analysis within the control arm|
1736810|NCT00475982|3197574|Superiority|||||||0.283|||||||paired t-test|||intra-analysis within the weight loss arm|
1736811|NCT00475982|3197575|Superiority||Mean Difference (Net)|2.22||||0.353|2-Sided|95.0|-2.58|7.02|||paired t-test|||analysis between the weight loss and control arms|
1736812|NCT00475982|3197575|Superiority|||||||0.986|||||||paired t-test|||intra-analysis within the control arm|
1736813|NCT00475982|3197575|Superiority|||||||0.162|||||||paired t-test|||intra-analysis within the weight loss arm|
1736814|NCT00475982|3197576|Superiority||Mean Difference (Net)|8.49||||0.186|2-Sided|95.0|-4.31|21.3|||paired t-test|||analysis between the weight loss and control arms|
1736815|NCT00475982|3197576|Superiority|||||||0.44|||||||paired t-test|||intra-analysis within the control arm|
1736816|NCT00475982|3197576|Superiority|||||||0.294|||||||paired t-test|||intra-analysis within the weight loss arm|
1736817|NCT00475982|3197577|Superiority||Mean Difference (Final Values)|0.884||||0.884|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1736818|NCT00475982|3197578|Superiority||Mean Difference (Final Values)|0.965||||0.965|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1736819|NCT00475904|3197579|Non-Inferiority or Equivalence|To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.|Mean Difference (Final Values)|0.046|Standard Error of the Mean|0.2311||0.8409|2-Sided|90.0|-0.33|0.43||To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.|ANCOVA|||the primary hypothesis of this study was that NP-1 topical cream (amitriptyline 4%/ketamine 2%) administered twice daily in doses of 4 gm for 4 weeks is not inferior to the standard treatment (oral gabapentin 600 mg 3 times daily) for relieving the pain of adult patients with PHN.|
1736820|NCT00475904|3197580|Superiority or Other||Mean Difference (Final Values)|0.547|Standard Error of the Mean|0.2709||0.0441|2-Sided|95.0|0.01|1.08||a priori threshold for statistical significance was p<0.05|ANOVA|||In the initial analysis, the efficacy of the test treatment NP-1 cream was compared with placebo using an analysis of variance (ANOVA). The analysis was conducted using the ITT population to compare the mean changes in pain scores from baseline to endpoint for the 2 treatments; the LOCF approach was employed for patients who did not complete the trial.|
1736821|NCT00475878|3197581|Superiority or Other||Mean Difference (Final Values)|0.96|Standard Error of the Mean|2.16||0.18|2-Sided|95.0|-2.79|5.84|||t-test, 2 sided||||
1736822|NCT00475878|3197582|Superiority or Other||Odds Ratio (OR)|0.64|Standard Error of the Mean|0.22||0.19|2-Sided|95.0|0.33|1.24|||Chi-squared||||
1736823|NCT00475852|3197591|Superiority or Other||Odds Ratio (OR)|1.09||||0.109|2-Sided|95.0|0.98|1.21|||Cochran-Mantel-Haenszel|Controlled for region.|||
1736824|NCT00475852|3197595|Superiority or Other||Risk Difference (RD)|-0.9||||0.238|2-Sided|95.0|-2.4|0.6|||Cochran-Mantel-Haenszel|Controlled for region.|For subjects with a Day 30 visit prior to Day 30, information from their Day 180 visit, if available, was used to impute the mortality and rehospitalization status at Day 30.||
1736825|NCT00475852|3197596|Superiority or Other||Mean Difference (Net)|0.2|Standard Error of the Mean|0.17||0.16|||||||ANOVA|Controlled for region.|This analysis excluded subjects who were lost to follow-up, or withdrawal of consent before Day 30, or whose Day 30 visit occurred prior to Day 30.||
1736826|NCT00475852|3197597|Superiority or Other||Risk Difference (RD)|-0.5||||0.295|2-Sided|95.0|-1.5|0.5|||Cochran-Mantel-Haenszel|Controlled for region.|||
1736827|NCT00475852|3197598|Superiority or Other|||||||0.018|||||||Van Elteren test|Controlled for region.|||
1736828|NCT00475852|3197599|Superiority or Other|||||||0.318|||||||Van Elteren test|Controlled for region.|||
1736829|NCT00475852|3197600|Superiority or Other|||||||0.007|||||||Van Elteren test|Controlled for region.|||
1736830|NCT00475852|3197601|Superiority or Other|||||||0.03|||||||Van Elteren test|Controlled for region.|||
1736831|NCT00475852|3197602|Superiority or Other||Risk Difference (RD)|-0.7||||0.313|2-Sided|95.0|-2.1|0.7|||Cochran-Mantel-Haenszel|Stratified by geographical region.|||
1736832|NCT00475735|3197615|Superiority or Other|||||||0.001||||||Since this is a proof of concept study with one primary hypothesis (AISRS total score for MK-0249 vs. placebo), there is no multiplicity adjustment.|Mixed Models Analysis|The terms were tobacco use, prior stimulant use, time, site, period, sequence, treatment, period-by-time, sequence-by-time, and treatment-by-time.|||
1741671|NCT00432809|3203964|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)||||
1736833|NCT00475735|3197615|Superiority or Other|||||||0.341||||||Since this is a proof of concept study with one primary hypothesis (AISRS total score for MK-0249 vs. placebo), there is no multiplicity adjustment.|Mixed Models Analysis|The terms were tobacco use, prior stimulant use, time, site, period, sequence, treatment, period-by-time, sequence-by-time, and treatment-by-time.|||
1736834|NCT00475644|3197635|Superiority||Odds Ratio (OR)|0.031|||||2-Sided|95.0|0.001|0.86|||||||
1736835|NCT00475501|3197640|Superiority or Other||Mean Difference (Net)|-0.868|Standard Error of the Mean|0.668||0.196|2-Sided|95.0|-3.434|1.698||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone ([T-placebo plus T-finasteride] vs. [vehicle-placebo plus vehicle-finasteride]).|Mixed Models Analysis|||The study was not powered for score on Lif Satisfaction A test|
1736836|NCT00475501|3197641|Superiority or Other||Mean Difference (Net)|5.33|Standard Deviation|1.83||0.0051|2-Sided|95.0|1.73|8.94||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone ([T-placebo plus T-finasteride] vs. [vehicle-placebo plus vehicle-finasteride]).|Mixed Models Analysis|||The study was powered for prostate volume based on a literature report that testosterone increases prostate volume 1.85 alpha per year. We employed a 2x2 analysis for effects of testosterone, finasteride and interaction.|
1736837|NCT00475501|3197642|Superiority or Other||Mean Difference (Net)|0.1419|Standard Error of the Mean|0.2529||0.6219|2-Sided|95.0|-0.353|6.37||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone ([T-placebo plus T-finasteride] vs. [vehicle-placebo plus vehicle-finasteride]).|Mixed Models Analysis|||The study was not powered for dietary protein intake|
1736838|NCT00475501|3197643|Superiority or Other||Mean Difference (Net)|4.13|Standard Deviation|0.54|<|0.001|2-Sided|95.0|3.07|5.18||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone ([T-placebo plus T-finasteride] vs. [vehicle-placebo plus vehicle-finasteride]).|Mixed Models Analysis|||This study was powered for hematocrit based on literature report that testosterone > 2 alpha increase in hematocrit|
1736839|NCT00475501|3197644|Superiority or Other||Mean Difference (Net)|0.587|Standard Error of the Mean|0.743||0.433|2-Sided|95.0|-0.869|2.043||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone ([T-placebo plus T-finasteride] vs. [vehicle-placebo plus vehicle-finasteride]).|Mixed Models Analysis|||The study was not powered for score on Benton test|
1736840|NCT00475501|3197645|Superiority or Other||Mean Difference (Net)|-0.642|Standard Error of the Mean|2.272||0.779|2-Sided|95.0|-5.095|3.811||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone ([T-placebo plus T-finasteride] vs. [vehicle-placebo plus vehicle-finasteride]).|Mixed Models Analysis|||The study was not powered for score on Trials A test|
1736841|NCT00475501|3197646|Superiority or Other||Mean Difference (Net)|2.871|Standard Error of the Mean|1.108||0.012|2-Sided|95.0|0.699|5.04||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone ([T-placebo plus T-finasteride] vs. [vehicle-placebo plus vehicle-finasteride]).|Mixed Models Analysis|||The study was not powered for 30-minute recall on Rey figure test|
1736842|NCT00475501|3197647|Superiority or Other||Mean Difference (Net)|-0.737|Standard Error of the Mean|0.343||0.037|2-Sided|95.0|-1.41|-0.064||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone ([T-placebo plus T-finasteride] vs. [vehicle-placebo plus vehicle-finasteride]).|Mixed Models Analysis|||The study is was not powered for score on Geriatric Depression Scale|
1736843|NCT00475501|3197648|Superiority or Other||Mean Difference (Net)|4.19|Standard Deviation|1.142|<|0.001|2-Sided|95.0|1.95|6.43||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone ([T-placebo plus T-finasteride] vs. [vehicle-placebo plus vehicle-finasteride]).|Mixed Models Analysis|||The study was not powered on lumbar spine bone mineral density. We employed a 2x2 analysis for effects ot testosterone, finasteride and interaction|
1736844|NCT00475501|3197649|Superiority or Other||Mean Difference (Net)|0.77|Standard Deviation|0.311||0.015|2-Sided|95.0|0.16|1.31||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone ([T-placebo plus T-finasteride] vs. [vehicle-placebo plus vehicle-finasteride]).|Mixed Models Analysis|||The study was not powered on grip strength. We employed 2x2 analysis to determine effects of testosterone, finasteride and interaction.|
1736845|NCT00475501|3197650|Superiority or Other||Mean Difference (Net)|12.9|Standard Deviation|2.57|<|0.001|2-Sided|95.0|7.86|18.0||The difference in means and p value are for 12 months (using data from all time points to make the calculation). We tested the effect of testosterone ([T-placebo plus T-finasteride] vs. [vehicle-placebo plus vehicle-finasteride]).|Mixed Models Analysis||mean difference is for subjects reveiving testosterone (groups T and T/F) vs. subjects not receiving testosterone (F and Placebo)|The studies was powered for 1-RM strength based on a 1.18-alpha increase reported in the literature|
1736846|NCT00475319|3197671|Superiority or Other|||||||0.001||||||versus placebo|t-test, 2 sided|a general linear model|||
1736847|NCT00475319|3197672|Superiority or Other|||||||0.001||||||versus placebo|t-test, 2 sided|a general linear model|||
1736848|NCT00475228|3197681|Superiority or Other|||||||0.05|||||||Chi-squared||||
1736849|NCT00475085|3197700|Superiority or Other||Mean Difference (Final Values)|-0.025||||0.557|2-Sided|95.0|-0.236|0.186||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 3 - Group 4 (aprepitant vs. prochlorperazine)|
1736850|NCT00475085|3197700|Superiority or Other||Mean Difference (Final Values)|0.195||||0.01|2-Sided|95.0|-0.017|0.407||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 1 - Group 4 (adding dexamethasone)|
1737310|NCT00471237|3198310|Superiority||Mean Difference (Net)|-1.02|Standard Error of the Mean|0.37||0.006|2-Sided|95.0|-1.74|-0.3|||ANOVA|||Total Hip aBMD, Month 12|
1736851|NCT00475085|3197700|Superiority or Other||Mean Difference (Final Values)|-0.013||||0.718|2-Sided|95.0|-0.225|0.2||Response skewed. P-value determined after Box-Cox transformation (lambda=-1.6). Significance level set to 0.017 to account for three tested hypotheses.|ANOVA|Testing and estimation performed using contrasts in the context of an omnibus ANOVA.||Group 1 - Group 2 (palonosetron vs. granisetron)|
1736852|NCT00475033|3197709|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.|Difference|-3.0|||||2-Sided|95.0|-9.4|3.4|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PRP: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|
1736853|NCT00475033|3197710|Superiority or Other||Ratio of geometric means|0.91|||||2-Sided|95.0|0.75|1.12|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PRP in Hib: Ratio of geometric means (13vPnC, 7vPnC)|
1736854|NCT00475033|3197711|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.|Difference|-1.8|||||2-Sided|95.0|-4.4|0.1|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|
1736855|NCT00475033|3197712|Superiority or Other||Ratio of geometric means|0.89|||||2-Sided|95.0|0.78|1.02|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|FIM: Ratio of geometric means (13vPnC, 7vPnC)|
1736856|NCT00475033|3197712|Superiority or Other||Ratio of geometric means|1.05|||||2-Sided|95.0|0.89|1.24|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PRN: Ratio of geometric means (13vPnC, 7vPnC)|
1736857|NCT00475033|3197712|Superiority or Other||Ratio of geometric means|1.12|||||2-Sided|95.0|1.01|1.25|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|FHA: Ratio of geometric means (13vPnC, 7vPnC)|
1736858|NCT00475033|3197712|Superiority or Other||Ratio of geometric means|1.14|||||2-Sided|95.0|1.02|1.27|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|PT: Ratio of geometric means (13vPnC, 7vPnC)|
1736859|NCT00475033|3197717|Superiority or Other||Ratio of geometric means|1.27|||||2-Sided|95.0|1.08|1.5|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Meningococcal C: Ratio of geometric means (13vPnC, 7vPnC)|
1736860|NCT00475033|3197718|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.|Difference|0.0|||||2-Sided|95.0|-1.4|1.4|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|
1736861|NCT00475033|3197719|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.|Difference|-2.1|||||2-Sided|95.0|-5.5|1.2|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|FIM: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage|
1736862|NCT00475033|3197719|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.|Difference|1.1|||||2-Sided|95.0|-1.7|4.2|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PRN: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|
1736863|NCT00475033|3197719|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.|Difference|0.0|||||2-Sided|95.0|-1.3|1.3|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|FHA: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|
1736864|NCT00475033|3197719|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.|Difference|0.0|||||2-Sided|95.0|-1.6|1.7|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|PT: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|
1736865|NCT00475033|3197720|Superiority or Other||Ratio of geometric means|1.19|||||2-Sided|95.0|0.96|1.48|||||CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).|Ratio of GMs (13vPnC, 7vPnC)|
1736866|NCT00475033|3197721|Non-Inferiority or Equivalence|Non-inferiority was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 treatment groups was > -10%.|Difference|-2.4|||||2-Sided|95.0|-5.3|-0.1|||||Exact 2-sided CI for the difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|Meningococcal C: Difference in proportions (13vPnC, 7vPnC) expressed as a percentage.|
1736867|NCT00474929|3197739|Superiority or Other||Maximum Tolerated Dose (MTD) Level|1.0|||||2-Sided||||||||Dose Level 1 was chosen as the MTD due to PI concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2. For the best interest of the patients, dose level 1 was chosen as the MTD and the dose level for Phase II.|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients).|
1736868|NCT00474903|3197741|Superiority or Other|||||||0.0204|||||||Wilcoxon (Mann-Whitney)||||
1736869|NCT00474903|3197741|Superiority or Other|||||||0.0955|||||||Wilcoxon (Mann-Whitney)||||
1736870|NCT00474851|3197742|Superiority or Other|||||||0.02||||||p (within group for participants receiving norethindrone + estrogens)=0.0001 p (within group for participants receiving norethindrone + placebo)=0.31 p (between groups)=0.02|RMANOVA|||"The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.~The primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA."|
1736871|NCT00474851|3197743|Superiority or Other|||||||0.1||||||p (within group for subjects receiving norethindrone + conjugated estrogens)=0.05 p (within group for subjects receiving norethindrone + placebo)=0.65 p (between the two groups)=0.10|RMANOVA|||"Analysis followed the intention-to-treat principle. The time course of each measurement from baseline to 3, 6, 9, and 12 months was compared between arms by repeated-measures analysis of variance (RM-ANOVA), with an autoregressive covariance model to account for visit-to-visit correlation within subjects.~The primary test of treatment efficacy was time × treatment interaction. Adjusted changes over time and differences between trial arms were constructed from parameters of the RMANOVA."|
1736872|NCT00474786|3197752|Superiority or Other||Cox Proportional Hazard|1.31||||0.0144|2-Sided|95.0|1.05|1.63||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and MSKCC prognostic group.|Log Rank||Hazard ratio <1 means temsirolimus (TEMSR) is at lower risk.||
1736873|NCT00474786|3197754|Superiority or Other||Cox Proportional Hazard|0.87||||0.1888|2-Sided|95.0|0.7|1.07||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.|Log Rank||Hazard ratio less than (<) 1 means temsirolimus (TEMSR) is at lower risk.||
1736874|NCT00474786|3197755|Superiority or Other||Cox Proportional Hazard|0.87||||0.1933|2-Sided|95.0|0.71|1.07||Stratified for nephrectomy status, duration of response to sunitinib therapy, tumor histology, and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group.|Log Rank||Hazard ratio less than (<) 1 means temsirolimus (TEMSR) is at lower risk.||
1736875|NCT00474630|3197785|Superiority or Other||Mean Difference (Net)|0.04|||||2-Sided|96.0|-0.76|0.85||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736876|NCT00474630|3197786|Superiority or Other||Mean Difference (Net)|0.43|||||2-Sided|95.0|-0.42|1.27||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736877|NCT00474630|3197787|Superiority or Other||Mean Difference (Net)|1.62|||||2-Sided|95.0|0.59|2.65||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736878|NCT00474630|3197788|Superiority or Other||Mean Difference (Net)|0.41|||||2-Sided|95.0|-1.04|1.86||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736879|NCT00474630|3197789|Superiority or Other||Mean Difference (Net)|1.16|||||2-Sided|95.0|-1.02|3.33||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736880|NCT00474630|3197790|Superiority or Other||Mean Difference (Net)|-1.43|||||2-Sided|95.0|-7.48|4.62||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736881|NCT00474630|3197791|Superiority or Other||Mean Difference (Net)|-4.98|||||2-Sided|95.0|-9.22|-0.74||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736882|NCT00474630|3197793|Superiority or Other||Mean Difference (Net)|-7.62|||||2-Sided|||||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736883|NCT00474630|3197794|Superiority or Other||Mean Difference (Net)|1.37|||||2-Sided|95.0|-0.77|3.51||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736884|NCT00474630|3197795|Superiority or Other||Odds Ratio (OR)|2.64|||||2-Sided|95.0|1.36|5.14||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736885|NCT00474630|3197796|Superiority or Other||Mean Difference (Net)|-3.13|||||2-Sided|||||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736886|NCT00474630|3197797|Superiority or Other||Mean Difference (Net)|-5.89|||||2-Sided|||||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736887|NCT00474630|3197798|Superiority or Other||Odds Ratio (OR)|2.63|||||2-Sided|95.0|0.55|12.67||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736888|NCT00474630|3197799|Superiority or Other||Odds Ratio (OR)|1.43|||||2-Sided|95.0|0.27|7.57||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736889|NCT00474630|3197800|Superiority or Other||Odds Ratio (OR)|0.55|||||2-Sided|95.0|0.35|0.86||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736890|NCT00474630|3197801|Superiority or Other||Odds Ratio (OR)|2.46|||||2-Sided|95.0|1.5|4.04||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736891|NCT00474630|3197802|Superiority or Other||Odds Ratio (OR)|3.75|||||2-Sided|95.0|1.79|7.88||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736892|NCT00474630|3197803|Superiority or Other||Mean Difference (Net)|-2.08|||||2-Sided|95.0|-3.57|-0.59||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1736893|NCT00474630|3197804|Superiority or Other||Mean Difference (Net)|-7.85||||0.065|2-Sided|95.0|-16.21|0.5|||ANCOVA||||
1736894|NCT00474630|3197805|Superiority or Other||Mean Difference (Net)|3.32|||<|0.001|2-Sided|95.0|1.8|4.84|||ANCOVA||||
1736895|NCT00474630|3197806|Superiority or Other||Mean Difference (Net)|-10.4||||0.007|2-Sided||||||ANCOVA||||
1736896|NCT00474630|3197807|Superiority or Other||Odds Ratio (OR)|3.44|||<|0.001|2-Sided|95.0|2.15|5.5|||Regression, Logistic||||
1736897|NCT00474630|3197808|Superiority or Other||Mean Difference (Net)|-0.49|||<|0.001|2-Sided|95.0|-0.71|-0.27|||ANCOVA||||
1736898|NCT00474630|3197809|Superiority or Other||Mean Difference (Net)|-3.28|||<|0.001||95.0|-4.34|-2.22|||ANCOVA||||
1736899|NCT00474539|3197819|Non-Inferiority or Equivalence|Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.6||||||95.0|-1.7|3.2||||||For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 1:8 titer was calculated.|
1736900|NCT00474539|3197822|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.81|1.24||||||For tetanus the GMC ratio (13vPnC/7vPnC) was calculated|
1741672|NCT00432809|3203964|Superiority or Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)||||
1736901|NCT00474539|3197822|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.93||||||95.0|0.78|1.1||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated|
1736902|NCT00474539|3197822|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.91||||||95.0|0.74|1.12||||||For tetanus the GMC ratio (13vPnC/7vPnC) was calculated|
1736903|NCT00474539|3197822|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.72|1.03||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated|
1736904|NCT00474539|3197823|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Ratio|0.0||||||95.0|-2.3|2.2||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.01 IU/mL threshold was calculated|
1736905|NCT00474539|3197823|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Ratio|0.0||||||95.0|-2.3|2.2||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated|
1736906|NCT00474539|3197823|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Ratio|0.0||||||95.0|-2.2|2.2||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.01 IU/mL threshold was calculated|
1736907|NCT00474539|3197823|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Ratio|0.0||||||95.0|-2.2|2.2||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated|
1736908|NCT00474539|3197823|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-2.1|2.0||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.01 IU/mL threshold was calculated|
1736909|NCT00474539|3197823|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-0.2||||||95.0|-4.4|4.0||||||For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated|
1736910|NCT00474539|3197823|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.9|1.7||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.01 IU/mL threshold was calculated|
1736911|NCT00474539|3197823|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-0.6||||||95.0|-3.5|2.0||||||For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 IU/mL threshold was calculated|
1736912|NCT00474539|3197824|Non-Inferiority or Equivalence|Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.23||||||95.0|0.97|1.55||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated|
1736913|NCT00474539|3197824|Non-Inferiority or Equivalence|Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.69|1.08||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated|
1736914|NCT00474539|3197827|Non-Inferiority or Equivalence|Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (>) -10%.|Difference|-0.5||||||95.0|-3.3|2.0||||||For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at >=1:8 titer was calculated|
1736915|NCT00474526|3197830|Non-Inferiority or Equivalence|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A–PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|1.0|||||2-Sided|95.0|-2.2|5.3||||||Hib (≥1.0 μg/mL) (percentage difference (LA3A - LA3B))|
1736916|NCT00474526|3197830|Non-Inferiority or Equivalence|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A–PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0|||||2-Sided|95.0|-3.1|3.6||||||Hib (≥ 0.15 μg/mL) (percentage difference (LA3A - LA3B))|
1736917|NCT00474526|3197830|Non-Inferiority or Equivalence|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A-PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|2.0|||||2-Sided|95.0|-7.2|10.6||||||Pertactin (percentage difference (LA3A - LA3B))|
1736918|NCT00474526|3197830|Non-Inferiority or Equivalence|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A–PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|-1.0|||||2-Sided|95.0|-10.2|8.2||||||FHA (percentage difference (LA3A - LA3B))|
1736919|NCT00474526|3197830|Non-Inferiority or Equivalence|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A–PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|6.0||||||95.0|-3.6|15.2||||||PT (percentage difference (LA3A - LA3B))|
1741673|NCT00432809|3203965|Superiority or Other|||||||0.85|||||||ANOVA||||
1736920|NCT00474526|3197830|Non-Inferiority or Equivalence|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A–PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0|||||2-Sided|95.0|-4.2|5.4||||||Tetanus (percentage difference (LA3A - LA3B))|
1736921|NCT00474526|3197830|Non-Inferiority or Equivalence|To assess non-inferiority of LA3A over LA3B, The lower limit of the two-sided 95% CI for the difference (PLA3A–PLA3B) in percentages of subjects with seroresponse against diphtheria, tetanus, Hib and pertussis antigens (except FHA for ≥4 fold rise) was greater than -10%|Percentage difference|0.0||||||95.0|-4.2|5.4||||||Diphtheria (percentage difference (LA3A - LA3B))|
1736922|NCT00474526|3197831|Non-Inferiority or Equivalence|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|0.86|||||2-Sided|95.0|0.63|1.16||||||Hib (Post-vaccination GMC; group ratio LA3A:LA3B)|
1736923|NCT00474526|3197831|Non-Inferiority or Equivalence|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.21|||||2-Sided|95.0|0.92|1.59||||||Pertactin (Post-vaccination GMC; group ratio LA3A:LA3B|
1736924|NCT00474526|3197831|Non-Inferiority or Equivalence|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.14|||||2-Sided|95.0|0.9|1.44||||||FHA (Post-vaccination GMC; group ratio LA3A:LA3B)|
1736925|NCT00474526|3197831|Non-Inferiority or Equivalence|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.11|||||2-Sided|95.0|0.88|1.4||||||PT (Post-vaccination GMC; group ratio LA3A:LA3B)|
1736926|NCT00474526|3197831|Non-Inferiority or Equivalence|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A / GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|0.94|||||2-Sided|95.0|0.75|1.18||||||Tetanus (Post-vaccination GMC; group ratio LA3A:LA3B)|
1736927|NCT00474526|3197831|Non-Inferiority or Equivalence|To assess non-inferiority of LA3A over LA3B, the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3A/GMCLA3B) had to be greater than 0.67 for PT, FHA and pertactin and greater than 0.50 for Hib, diphtheria and tetanus.|Ratio of GMCs|1.05|||||2-Sided|95.0|0.86|1.27||||||Diphtheria (Post-vaccination GMC; group ratio LA3A:LA3B)|
1736928|NCT00474526|3197832|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A – PLA1B) had to be greater than -10%.|Percentage difference|0.0|||||2-Sided|95.0|-7.0|7.0||||||PnC 23F (percentage difference (LA1A - LA1B))|
1736929|NCT00474526|3197832|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A – PLA1B) had to be greater than -10%.|Percentage difference|-3.0|||||2-Sided|95.0|-11.6|5.2||||||PnC 19F (percentage difference (LA1A - LA1B))|
1736930|NCT00474526|3197832|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A – PLA1B) had to be greater than -10%.|Percentage difference|-14.0|||||2-Sided|95.0|-24.1|-5.6||||||PnC 18C (percentage difference (LA1A - LA1B))|
1736931|NCT00474526|3197832|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A – PLA1B) had to be greater than -10%.|Percentage difference|-1.0|||||2-Sided|95.0|-5.6|2.7||||||PnC 14 (percentage difference (LA1A - LA1B))|
1736932|NCT00474526|3197832|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A – PLA1B) had to be greater than -10%.|Percentage difference|-3.0|||||2-Sided|95.0|-10.9|4.3||||||PnC 9V (percentage difference (LA1A - LA1B))|
1736933|NCT00474526|3197832|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A – PLA1B) had to be greater than -10%.|Percentage difference|-2.0|||||2-Sided|95.0|-11.9|7.3||||||PnC 6B (percentage difference (LA1A - LA1B))|
1736934|NCT00474526|3197832|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the difference in rates (PLA1A – PLA1B) had to be greater than -10%.|Percentage difference|-2.0|||||2-Sided|95.0|-9.6|5.2||||||PnC 4 (percentage difference (LA1A - LA1B))|
1736935|NCT00474526|3197833|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.74|||||2-Sided|95.0|0.54|1.01||||||PnC 23F (Post-vaccination GMC; group ratio LA1A:LA1B)|
1736936|NCT00474526|3197833|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.77|||||2-Sided|95.0|0.56|1.04||||||PnC 19F (Post-vaccination GMC; group ratio LA1A:LA1B)|
1736937|NCT00474526|3197833|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.78|||||2-Sided|95.0|0.6|1.01||||||PnC 18C (Post-vaccination GMC; group ratio LA1A:LA1B)|
1736938|NCT00474526|3197833|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.65|||||2-Sided|95.0|0.51|0.82||||||PnC 14 (Post-vaccination GMC; group ratio LA1A:LA1B)|
1736939|NCT00474526|3197833|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.74|||||2-Sided|95.0|0.58|0.94||||||PnC 9V (Post-vaccination GMC; group ratio LA1A:LA1B)|
1737311|NCT00471237|3198310|Superiority||Mean Difference (Net)|-0.89|Standard Error of the Mean|0.36||0.015|2-Sided|95.0|-1.61|-0.17|||ANOVA|||Total Hip aBMD, Month 12|
1736940|NCT00474526|3197833|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.81|||||2-Sided|95.0|0.54|1.2||||||PnC 6B (Post-vaccination GMC; group ratio LA1A:LA1B)|
1736941|NCT00474526|3197833|Non-Inferiority or Equivalence|To assess non-inferiority of LA1A over LA1B, the lower limit of the two-sided 95% CI for the ratio of pneumococcal GMCs (GMCLA1A / GMCLA1B) had to be greater than 0.50.|Ratio of GMCs|0.79|||||2-Sided|95.0|0.61|1.02||||||PnC 4 (Post-vaccination GMC; group ratio LA1A:LA1B)|
1736942|NCT00474526|3197834|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A – PUS1B) had to be greater than -10%.|Percentage difference|-2.0|||||2-Sided|95.0|-10.0|5.0||||||PnC 239F (percentage difference (US1A:US1B))|
1736943|NCT00474526|3197834|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A – PUS1B) had to be greater than -10%.|Percentage difference|4.0|||||2-Sided|95.0|-4.0|11.0||||||PnC 19F (percentage difference (US1A:US1B))|
1736944|NCT00474526|3197834|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A – PUS1B) had to be greater than -10%.|Percentage difference|-6.0|||||2-Sided|95.0|-15.0|3.0||||||PnC 18C (percentage difference (US1A:US1B))|
1736945|NCT00474526|3197834|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A – PUS1B) had to be greater than -10%.|Percentage difference|-1.0|||||2-Sided|95.0|-6.0|3.0||||||PnC 14 (percentage difference (US1A - US1B))|
1736946|NCT00474526|3197834|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A – PUS1B) had to be greater than -10%.|Percentage difference|-4.0|||||2-Sided|95.0|-13.0|5.0||||||PnC 9V (percentage difference (US1A - US1B))|
1736947|NCT00474526|3197834|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A – PUS1B) had to be greater than -10%.|Percentage difference|4.0|||||2-Sided|95.0|0.0|10.0||||||PnC 6B (percentage difference (US1A - US1B))|
1736948|NCT00474526|3197834|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the difference in rates (PUS1A – PUS1B) had to be greater than -10%.|Percentage difference|1.0|||||2-Sided|95.0|-8.0|10.0||||||PnC 4 (percentage difference (US1A - US1B))|
1736949|NCT00474526|3197835|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.94|||||2-Sided|95.0|0.69|1.29||||||PnC 23F (Post-vaccination GMC; group ratio US1A:US1B)|
1736950|NCT00474526|3197835|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|1.04||||||95.0|0.81|1.34||||||PnC 19F (Post-vaccination GMC; group ratio US1A:US1B)|
1736951|NCT00474526|3197835|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|1.02|||||2-Sided|95.0|0.78|1.34||||||PnC 18C (Post-vaccination GMC; group ratio US1A:US1B)|
1736952|NCT00474526|3197835|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.8|||||2-Sided|95.0|0.63|1.03||||||PnC 14 (Post-vaccination GMC; group ratio US1A:US1B)|
1736953|NCT00474526|3197835|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.89|||||2-Sided|95.0|0.67|1.2||||||PnC 9V (Post-vaccination GMC; group ratio US1A:US1B)|
1736954|NCT00474526|3197835|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.8|||||2-Sided|95.0|0.62|1.02||||||PnC 6B (Post-vaccination GMC; group ratio US1A:US1B)|
1736955|NCT00474526|3197835|Non-Inferiority or Equivalence|To assess non-inferiority of US1A over US1B, the lower limit of 95% CI for the ratio of pneumococcal GMCs (GMCUS1A / GMCUS1B) had to be greater than 0.50.|Ratio of GMCs|0.9|||||2-Sided|95.0|0.67|1.2||||||PnC 4 (Post-vaccination GMC; group ratio US1A:US1B)|
1736956|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0||||||95.0|-3.7|7.0||||||PnC 23F (Seroconversion percentage difference (PLA3 - PLA4))|
1736957|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||2-Sided|95.0|-0.8|7.5||||||PnC 19F (Seroconversion percentage difference (PLA3 - PLA4))|
1736958|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-3.0|||||2-Sided|95.0|-7.2|0.8||||||PnC 18C (Seroconversion percentage difference (PLA3 - PLA4))|
1736959|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||2-Sided|95.0|-3.7|3.4||||||PnC 14 (Seroconversion percentage difference (PLA3 - PLA4))|
1736960|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||2-Sided|95.0|-2.8|6.0||||||PnC 9V (Seroconversion percentage difference (PLA3 - PLA4))|
1737312|NCT00471237|3198310|Superiority||Mean Difference (Net)|-1.3|Standard Error of the Mean|0.33||0|2-Sided|95.0|-1.95|-0.65|||ANOVA|||Total Hip aBMD, Month 6|
1736961|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||2-Sided|95.0|-4.0|9.0||||||PnC 6B (Seroconversion percentage difference (PLA3 - PLA4))|
1736962|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||2-Sided|95.0|-4.2|3.0||||||PnC 4 (Seroconversion percentage difference (PLA3 - PLA4))|
1736963|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0||||||95.0|-6.6|3.0||||||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))|
1736964|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||2-Sided|95.0|-5.3|1.0||||||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA3 - PLA4))|
1736965|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||2-Sided|95.0|-2.3|2.7||||||Hepatitis B (Seroconversion percentage difference (PLA3 - PLA4))|
1736966|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||2-Sided|95.0|-4.4|4.5||||||Polio Type 3 (Seroconversion percentage difference (PLA3 - PLA4))|
1736967|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||2-Sided|95.0|-3.0|4.8||||||Polio Type 2 (Seroconversion percentage difference (PLA3 - PLA4))|
1736968|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||2-Sided|95.0|-2.0|4.7||||||Polio Type 1 (Seroconversion percentage difference (PLA3 - PLA4))|
1736969|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||2-Sided|95.0|-8.0|5.7||||||Pertactin (Seroconversion percentage difference (PLA3 - PLA4))|
1736970|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||2-Sided|95.0|-7.1|8.8||||||FHA(Seroconversion percentage difference (PLA3 - PLA4))|
1736971|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0|||||2-Sided|95.0|-4.8|10.7||||||PT (Seroconversion percentage difference (PLA3 - PLA4))|
1736972|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0||||||95.0|-1.3|2.7||||||Tetanus (Seroconversion percentage difference (PLA3 - PLA4))|
1736973|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of the two-sided 95% CI for the difference in seroresponse rates (PLA3 – PLA4) must be greater than 5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||2-Sided|95.0|-2.3|3.8||||||Diphtheria (Seroconversion percentage difference (PLA3 - PLA4))|
1736974|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-4.0|||||2-Sided|95.0|-8.0|1.9||||||PnC 23F (Seroconversion percentage difference (PLA1 - PLA2))|
1736975|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||2-Sided|95.0|-4.8|2.9||||||PnC 19F (Seroconversion percentage difference (PLA1 - PLA2))|
1736976|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||2-Sided|95.0|-4.8|2.9||||||PnC 18C (Seroconversion percentage difference (PLA1 - PLA2))|
1736977|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||2-Sided|95.0|-1.1|6.2||||||PnC 14 (Seroconversion percentage difference (PLA1 - PLA2))|
1736978|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||2-Sided|95.0|-3.9|3.6||||||PnC 9V (Seroconversion percentage difference (PLA1 - PLA2))|
1736979|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|4.0|||||2-Sided|95.0|-2.2|12.3||||||PnC 6B(Seroconversion percentage difference (PLA1 - PLA2))|
1736980|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||2-Sided|95.0|-3.0|3.3||||||PnC 4(Seroconversion percentage difference (PLA1 - PLA2))|
1736981|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|2.0||||||95.0|-2.8|7.7||||||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))|
1736982|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|1.0|||||2-Sided|95.0|-1.1|5.0||||||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PLA1 - PLA2))|
1736983|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||2-Sided|95.0|-1.5|3.5||||||Hepatitis B (Seroconversion percentage difference (PLA1 - PLA2))|
1736984|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||2-Sided|95.0|-3.2|5.1||||||Polio Type 3 (Seroconversion percentage difference (PLA1 - PLA2))|
1736985|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||2-Sided|95.0|-4.6|2.3||||||Polio Type 2 (Seroconversion percentage difference (PLA1 - PLA2))|
1736986|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||2-Sided|95.0|-4.8|1.0||||||Polio Type 1 (Seroconversion percentage difference (PLA1 - PLA2))|
1736987|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-6.0||||||95.0|-12.9|2.2||||||Pertactin (Seroconversion percentage difference (PLA1 - PLA2))|
1736988|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-2.0|||||2-Sided|95.0|-9.2|5.8||||||FHA(Seroconversion percentage difference (PLA1 - PLA2))|
1736989|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|-1.0|||||2-Sided|95.0|-7.7|7.1||||||PT (Seroconversion percentage difference (PLA1 - PLA2))|
1736990|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||2-Sided|95.0|-1.9|2.6||||||Tetanus (Seroconversion percentage difference (PLA1 - PLA2))|
1736991|NCT00474526|3197850|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the difference in seroresponse rates (PLA1 – PLA2) must be greater than -5% for poliovirus and greater than -10% for all other antigens.|Seroconversion Percentage difference|0.0|||||2-Sided|95.0|-2.2|4.4||||||Diphtheria (Seroconversion percentage difference (PLA1 - PLA2))|
1736992|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.88|||||2-Sided|95.0|0.69|1.12||||||PnC 23F (Post-vaccination GMC; group ratio LA3:LA4)|
1736993|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.91|||||2-Sided|95.0|0.75|1.1||||||PnC 19F (Post-vaccination GMC; group ratio LA3:LA4)|
1736994|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.75|||||2-Sided|95.0|0.62|0.9||||||PnC 18C (Post-vaccination GMC; group ratio LA3:LA4)|
1736995|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.84||||||95.0|0.67|1.05||||||PnC 14 (Post-vaccination GMC; group ratio LA3:LA4)|
1737313|NCT00471237|3198310|Superiority||Mean Difference (Net)|-1.28|Standard Error of the Mean|0.32||0|2-Sided|95.0|-1.92|-0.64|||ANOVA|||Total Hip aBMD, Month 6|
1736996|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.83|||||2-Sided|95.0|0.69|1.0||||||PnC 9V (Post-vaccination GMC; group ratio LA3:LA4)|
1736997|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.87|||||2-Sided|95.0|0.67|1.14||||||PnC 6B (Post-vaccination GMC; group ratio LA3:LA4)|
1736998|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.8|||||2-Sided|95.0|0.68|0.95||||||PnC 4 (Post-vaccination GMT; group ratio LA3:LA4)|
1736999|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|1.07|||||2-Sided|95.0|0.83|1.37||||||HIb (Post-vaccination GMC; group ratio LA3:LA4)|
1737000|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.95|||||2-Sided|95.0|0.76|1.19||||||Hepatitis B (Post-vaccination GMT; group ratio LA3:LA4)|
1737001|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.81|||||2-Sided|95.0|0.59|1.11||||||Polio Type 3 (Post-vaccination GMT; group ratio LA3:LA4)|
1737002|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.83|||||2-Sided|95.0|0.63|1.09||||||Polio Type 2 (Post-vaccination GMT; group ratio LA3:LA4)|
1737003|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMTs|0.78|||||2-Sided|95.0|0.6|1.02||||||Polio Type 1 (Post-vaccination GMT; group ratio LA3:LA4)|
1737004|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.8|||||2-Sided|95.0|0.66|0.97||||||Pertactin (Post-vaccination GMC; group ratio LA3:LA4|
1737005|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.88|||||2-Sided|95.0|0.75|1.03||||||FHA (Post-vaccination GMC; group ratio LA3:LA4)|
1737006|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.93||||||95.0|0.78|1.1||||||PT (Post-vaccination GMC; group ratio LA3:LA4)|
1737007|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.95|||||2-Sided|95.0|0.83|1.09||||||Tetanus (Post-vaccination GMC; group ratio LA3:LA4)|
1737008|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA3 over LA4, the lower limit of two-sided 95% CI for the ratio of pertussis GMCs (GMCLA3 / GMCLA4) must be greater than 0.67; the lower limit of the two-sided 95% CI for the ratio of GMCs (GMCLA3 / GMCLA4) or GMTs (poliovirus antigens) for the other antigens must be greater than 0.50.|Ratio of GMCs|0.82|||||2-Sided|95.0|0.69|0.99||||||Diphtheria (Post-vaccination GMC; group ratio LA3:LA4)|
1737009|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.77|||||2-Sided|95.0|0.6|0.99||||||PnC 23F (Post-vaccination GMC; group ratio LA1:LA2)|
1737010|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.9|||||2-Sided|95.0|0.74|1.1||||||PnC 19F (Post-vaccination GMC; group ratio LA1:LA2)|
1737011|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.89|||||2-Sided|95.0|0.74|1.08||||||PnC 18C (Post-vaccination GMC; group ratio LA1:LA2)|
1741674|NCT00432809|3203965|Superiority or Other||||||<|0.001|||||||ANOVA||||
1737012|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.91|||||2-Sided|95.0|0.72|1.14||||||PnC 14 (Post-vaccination GMC; group ratio LA1:LA2)|
1737013|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.86|||||2-Sided|95.0|0.71|1.04||||||PnC 9V (Post-vaccination GMC; group ratio LA1:LA2)|
1737014|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.97|||||2-Sided|95.0|0.74|1.27||||||PnC 6B (Post-vaccination GMC; group ratio LA1:LA2)|
1737015|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.92|||||2-Sided|95.0|0.78|1.09||||||PnC 4 (Post-vaccination GMC; group ratio LA1:LA2)|
1737016|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.27|||||2-Sided|95.0|0.98|1.65||||||HIb (Post-vaccination GMC; group ratio LA1:LA2)|
1737017|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.11|||||2-Sided|95.0|0.88|1.4||||||Hepatitis B (Post-vaccination GMC; group ratio LA1:LA2)|
1737018|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.95||||||95.0|0.69|1.31||||||Polio Type 3 (Post-vaccination GMT; group ratio LA1:LA2)|
1737019|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.97|||||2-Sided|95.0|0.73|1.28||||||Polio Type 2 (Post-vaccination GMT; group ratio LA1:LA2)|
1737020|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMTs|0.9|||||2-Sided|95.0|0.68|1.17||||||Polio Type 1 (Post-vaccination GMT; group ratio LA1:LA2)|
1737021|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|0.99|||||2-Sided|95.0|0.81|1.21||||||Pertactin (Post-vaccination GMC; group ratio LA1:LA2)|
1737022|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.05|||||2-Sided|95.0|0.89|1.23||||||FHA (Post-vaccination GMC; group ratio LA1:LA2)|
1737023|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.04|||||2-Sided|95.0|0.87|1.25||||||PT (Post-vaccination GMC; group ratio LA1:LA2)|
1737024|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.1|||||2-Sided|95.0|0.96|1.27||||||Tetanus (Post-vaccination GMC; group ratio LA1:LA2)|
1737025|NCT00474526|3197851|Non-Inferiority or Equivalence|To assess non-inferiority of LA1 to LA2, the lower limit of the 95% CI for the ratio of pertussis GMCs (GMCLA1 / GMCLA2) must be greater than 0.67; the lower limit of the 95% CI for the ratio of all other GMCs (GMCLA1 / GMCLA2) must be greater than 0.50.|Ratio of GMCs|1.16|||||2-Sided|95.0|0.96|1.4||||||Diphtheria (Post-vaccination GMC; group ratio LA1:LA2)|
1737026|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||2-Sided|95.0|-8.0|5.0||||||PnC 23F (Seroconversion percentage difference (PUS1 – PUS2))|
1737027|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|(Seroconversion percentage difference (P|-1.0|||||2-Sided|95.0|-4.0|3.0||||||PnC 19F (Seroconversion percentage difference (PUS1 – PUS2))|
1737028|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-3.0|||||2-Sided|95.0|-6.0|1.0||||||PnC 18C (Seroconversion percentage difference (PUS1 – PUS2))|
1737029|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Diphtheria (Seroconversion percentage di|1.0|||||2-Sided|95.0|-1.0|5.0||||||PnC 14 (Seroconversion percentage difference (PUS1 – PUS2))|
1741675|NCT00432809|3203965|Superiority or Other||||||<|0.001|||||||ANOVA||||
1737030|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||2-Sided|95.0|-4.0|5.0||||||PnC 9V (Seroconversion percentage difference (PUS1 – PUS2))|
1737031|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|(Seroconversion percentage difference (P|-8.0|||||2-Sided|95.0|-14.0|-1.0||||||PnC 6B(Seroconversion percentage difference (PUS1 - PUS2))|
1737032|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||2-Sided|95.0|-5.0|2.0||||||PnC 4(Seroconversion percentage difference (PUS1 – PUS2))|
1737033|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|5.0|||||2-Sided|95.0|-3.0|14.0||||||Hib (≥1.0 μg/mL)(Seroconversion percentage difference (PUS1 – PUS2))|
1737034|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||2-Sided|95.0|-3.0|3.0||||||Hib (≥ 0.15 μg/mL)(Seroconversion percentage difference (PUS1 – PUS2))|
1737035|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||2-Sided|95.0|-4.0|3.0||||||Hepatitis B(Seroconversion percentage difference (PUS1 – PUS2))|
1737036|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||2-Sided|95.0|-3.0|3.0||||||Polio Type 3 (Seroconversion percentage difference (PUS1 - PUS2))|
1737037|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||2-Sided|95.0|-2.0|4.0||||||Polio Type 2 (Seroconversion percentage difference (PUS1 – PUS2))|
1737038|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-1.0|||||2-Sided|95.0|-3.0|3.0||||||Polio Type 1 (Seroconversion percentage difference (PUS1 – PUS2))|
1737039|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|-2.0|||||2-Sided|95.0|-12.0|10.0||||||Pertactin (Seroconversion percentage difference (PUS1 – PUS2))|
1737040|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|6.0|||||2-Sided|95.0|-4.0|17.0||||||FHA(Seroconversion percentage difference (PUS1 – PUS2))|
1737041|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|2.0|||||2-Sided|95.0|-7.0|12.0||||||PT (Seroconversion percentage difference (PUS1 – PUS2))|
1737042|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||2-Sided|95.0|-2.0|4.0||||||Tetanus (Seroconversion percentage difference (PUS1 – PUS2))|
1737043|NCT00474526|3197852|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the difference in seroresponse rates (PUS1 – PUS2) must be greater than -5% for polio and -10% for all others.|Seroconversion Percentage difference|0.0|||||2-Sided|95.0|-3.0|3.0||||||Diphtheria (Seroconversion percentage difference (PUS1 – PUS2))|
1737044|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.79|||||2-Sided|95.0|0.62|1.02||||||PnC 23F (Post-vaccination GMT; group ratio US1:US2)|
1737045|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.82|||||2-Sided|95.0|0.69|0.97||||||PnC 19F (Post-vaccination GMT; group ratio US1:US2)|
1737046|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.77|||||2-Sided|95.0|0.64|0.93||||||PnC 18C (Post-vaccination GMT; group ratio US1:US2)|
1737047|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.03|||||2-Sided|95.0|0.84|1.26||||||PnC 14 (Post-vaccination GMT; group ratio US1:US2)|
1737048|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.85||||||95.0|0.7|1.04||||||PnC 9V (Post-vaccination GMT; group ratio US1:US2)|
1737049|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.76|||||2-Sided|95.0|0.56|1.03||||||PnC 6B (Post-vaccination GMT; group ratio US1:US2)|
1737050|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.84|||||2-Sided|95.0|0.7|1.0||||||PnC 4 (Post-vaccination GMT; group ratio US1:US2)|
1737051|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.31|||||2-Sided|95.0|0.97|1.77||||||HIb (Post-vaccination GMT; group ratio US1:US2)|
1737052|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.88||||||95.0|0.65|1.2||||||Hepatitis B (Post-vaccination GMT; group ratio US1:US2)|
1737053|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.15|||||2-Sided|95.0|0.85|1.56||||||Polio Type 3 (Post-vaccination GMT; group ratio US1:US2)|
1737054|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.2|||||2-Sided|95.0|0.93|1.55||||||Polio Type 2 (Post-vaccination GMT; group ratio US1:US2)|
1737055|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.96|||||2-Sided|95.0|0.75|1.23||||||Polio Type 1 (Post-vaccination GMT; group ratio US1:US2)|
1737056|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.04|||||2-Sided|95.0|0.83|1.32||||||Pertactin (Post-vaccination GMT; group ratio US1:US2|
1737057|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.03|||||2-Sided|95.0|0.85|1.25||||||FHA (Post-vaccination GMT; group ratio US1:US2)|
1737058|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.0|||||2-Sided|95.0|0.79|1.26||||||PT (Post-vaccination GMT; group ratio US1:US2)|
1737059|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|1.08|||||2-Sided|95.0|0.92|1.28||||||Tetanus (Post-vaccination GMT; group ratio US1:US2)|
1737060|NCT00474526|3197853|Non-Inferiority or Equivalence|To assess non-inferiority of US1 over US2, the lower limit of 95% CI for the ratio of pertussis GMCs (GMCUS1 /GMCUS2) must be greater than 0.67; the lower limit of 95% CI for the ratio of all other GMCs (GMCUS1 / GMCUS2) must be greater than 0.50.|Ratio of GMTs|0.87|||||2-Sided|95.0|0.74|1.04||||||Diphtheria (Post-vaccination GMT; group ratio US1:US2)|
1737061|NCT00474526|3197855|Non-Inferiority or Equivalence|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 – PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-1.0|||||2-Sided|95.0|-4.0|1.7||||||Serogroup Y (post-vaccination percentage of subjects with hSBA titer >=8, group difference (PLA1 - PLA3))|
1737062|NCT00474526|3197855|Non-Inferiority or Equivalence|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 – PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|1.0|||||2-Sided|95.0|-1.3|3.1||||||Serogroup W (post-vaccination percentage of subjects with hSBA titer >=8, group difference (PLA1 - PLA3))|
1737063|NCT00474526|3197855|Non-Inferiority or Equivalence|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 – PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-3.0|||||2-Sided|95.0|-7.0|0.3||||||Serogroup C (post-vaccination percentage of subjects with hSBA titer >=8, group difference (PLA1 - PLA3))|
1737064|NCT00474526|3197855|Non-Inferiority or Equivalence|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the difference in percentage of subjects with hSBA ≥ 1:8 and ≥1:4 between the 2 dose and the 3 dose schedule (PLA1 – PLA3) must be greater than -10%.|Percentage (hSBA titers >=8) difference|-15.0|||||2-Sided|95.0|-21.2|-8.5||||||Serogroup A (post-vaccination percentage of subjects with hSBA titer >=8, group difference (PLA1 - PLA3))|
1737065|NCT00474526|3197858|Non-Inferiority or Equivalence|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be > 0.5.|Ratio of GMTs|1.27|||||2-Sided|95.0|1.02|1.58||||||Serogroup Y (Post-vaccination GMT; group ratio LA1:LA3)|
1737066|NCT00474526|3197858|Non-Inferiority or Equivalence|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be > 0.5.|Ratio of GMTs|1.42|||||2-Sided|95.0|1.18|1.72||||||Serogroup W (Post-vaccination GMT; group ratio LA1:LA3)|
1737067|NCT00474526|3197858|Non-Inferiority or Equivalence|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be > 0.5.|Ratio of GMTs|1.03|||||2-Sided|95.0|0.81|1.31||||||Serogroup C (Post-vaccination GMT; group ratio LA1:LA3)|
1737068|NCT00474526|3197858|Non-Inferiority or Equivalence|LA1 was noninferior to LA3, if the lower limit of the two-sided 95% CI for the ratio of GMTs between the 2 dose and the 3 dose schedule (GMTLA1/GMTLA3) must be > 0.5.|Ratio of GMT|0.73|||||2-Sided|95.0|0.55|0.95||||||Serogroup A (Post-vaccination GMT; group ratio LA1:LA3)|
1737069|NCT00474526|3197867|Superiority or Other||Ratio of GMTs|38.0|||||2-Sided|95.0|24.0|60.0|||||Y (Post-vaccination GMT; group ratio US1A:US2)|"Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was >= 2.0.~Ratio of GMTs"|
1737070|NCT00474526|3197867|Superiority or Other||Ratio of GMTs|37.0|||||2-Sided|95.0|24.0|58.0|||||W (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was >= 2.0.|
1737071|NCT00474526|3197867|Superiority or Other||Ratio of GMTs|6.39|||||2-Sided|95.0|4.16|9.79|||||C (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was >= 2.0.|
1737072|NCT00474526|3197867|Superiority or Other||Ratio of GMTs|4.53|||||2-Sided|95.0|3.04|6.74|||||A (Post-vaccination GMT; group ratio US1A:US2)|Using the MenACWY GMTs, immunogenicity of the fourth dose at 1 month after the 12-month vaccination in those subjects receiving MenACWY at 2, 4, and 6 months was considered superior to the immune response of a single dose given at 12-months of age if the lower limit of the two-sided 95% CI of the ratio of the two GMTs was >= 2.0.|
1737073|NCT00474266|3197908|Non-Inferiority|Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%.|Difference in percentage|3.36|||||2-Sided|95.0|-0.28|9.5|||||||
1737074|NCT00474266|3197909|Non-Inferiority|Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥ -10%|Difference in percentage|0.0|||||2-Sided|95.0|-1.06|3.18|||||||
1737075|NCT00474266|3197910|Non-Inferiority|Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%.|Difference in percentage|4.06|||||2-Sided|95.0|-2.82|12.46|||||||
1737076|NCT00474266|3197911|Non-Inferiority|Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥ -10%.|Difference in percentage|0.0|||||2-Sided|95.0|-1.06|3.17|||||||
1737077|NCT00474266|3197912|Non-Inferiority|Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥ -10%.|Difference in percentage|0.0|||||2-Sided|95.0|-1.06|1.07|||||||
1737078|NCT00474266|3197912|Non-Inferiority|Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥ -10%.|Difference in percentage|0.28|||||2-Sided|95.0|-0.79|1.58|||||||
1737079|NCT00474266|3197912|Non-Inferiority|Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥ -10%|Difference in percentage|0.28|||||2-Sided|95.0|-0.78|1.58|||||||
1737080|NCT00474266|3197912|Non-Inferiority|Non-inferiority criterion: Lower limit [LL] of the 2-sided standardized asymptotic 95% confidence interval [CI] ≥-10%.|Difference in percentage|2.2|||||2-Sided|95.0|0.29|6.78|||||||
1737081|NCT00474201|3197922|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|Students paired, two-tailed T-test||"Null hypothesis: lopinavir-ritonavir does not alter gemfibrozil pharmacokinetics.~A sample size of 13 healthy subjects yielded 81% power to detect a clinically relevant change of 30% in gemfibrozil AUC with concomitant lopinavir-ritonavir (alpha = 0.05; beta = 0.2). Gemfibrozil pharmacokinetic parameters derived pre- and post lopinavir-ritonavir exposure (Days 1 and 14, respectively) were compared using a paired Students t test."|
1737082|NCT00474175|3197930|Superiority or Other||Treatment difference|-0.01||||0.944|2-Sided|95.0|-0.15|0.13||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 20% versus Benzocaine 10%) and the associated confidence interval were calculated based on the weighted Gamma statistic.|
1737083|NCT00474175|3197930|Superiority or Other||Treatment difference|0.16||||0.039|2-Sided|95.0|0.0|0.33||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 10% versus Placebo) and the associated confidence interval were calculated based on the weighted Gamma statistic.|
1737084|NCT00474175|3197930|Superiority or Other||Treatment difference|0.17||||0.035|2-Sided|95.0|0.01|0.33||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Cochran-Mantel-Haenszel|||P-value was calculated from the CMH test with modified ridit scores, adjusted for site baseline pain intensity. Treatment difference (Benzocaine 20% versus Placebo) and the associated confidence interval were calculated based on the weighted Gamma statistic.|
1737085|NCT00474175|3197931|Superiority or Other||Treatment difference|0.04||||0.855|2-Sided|95.0|-0.43|0.52||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737172|NCT00473590|3198065|Superiority or Other||Hazard Ratio (HR)|0.836||||0.6665|2-Sided|95.0|0.369|1.893||The tests were exploratory because patients were not randomized to the two arms with respect to response status.|Log Rank||The hazard ratios were estimated using Cox regression.|Unstratified analysis.|
1742612|NCT00424762|3205164|Superiority or Other|||||||0.03|||||||Chi-squared|||comparative incidence|
1737086|NCT00474175|3197931|Superiority or Other||Treatment difference|0.06||||0.839|2-Sided|95.0|-0.52|0.64||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737087|NCT00474175|3197931|Superiority or Other||Treatment difference|0.1||||0.725|2-Sided|95.0|-0.48|0.69||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||120 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737088|NCT00474175|3197931|Superiority or Other||Treatment difference|0.09||||0.721|2-Sided|95.0|-0.39|0.56||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737089|NCT00474175|3197931|Superiority or Other||Treatment difference|0.17||||0.563|2-Sided|95.0|-0.41|0.76||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737090|NCT00474175|3197931|Superiority or Other||Treatment difference|0.26||||0.386|2-Sided|95.0|-0.33|0.84||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||110 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737091|NCT00474175|3197931|Superiority or Other||Treatment difference|-0.04||||0.859|2-Sided|95.0|-0.52|0.43||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737092|NCT00474175|3197931|Superiority or Other||Treatment difference|0.2||||0.511|2-Sided|95.0|-0.39|0.78||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737093|NCT00474175|3197931|Superiority or Other||Treatment difference|0.15||||0.61|2-Sided|95.0|-0.43|0.74||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||100 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737094|NCT00474175|3197931|Superiority or Other||Treatment difference|0.07||||0.769|2-Sided|95.0|-0.41|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737095|NCT00474175|3197931|Superiority or Other||Treatment difference|0.25||||0.412|2-Sided|95.0|-0.34|0.83||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737096|NCT00474175|3197931|Superiority or Other||Treatment difference|0.32||||0.29|2-Sided|95.0|-0.27|0.91||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||90 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737097|NCT00474175|3197931|Superiority or Other||Treatment difference|0.18||||0.465|2-Sided|95.0|-0.3|0.65||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737098|NCT00474175|3197931|Superiority or Other||Treatment difference|0.15||||0.612|2-Sided|95.0|-0.43|0.73||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737099|NCT00474175|3197931|Superiority or Other||Treatment difference|0.33||||0.271|2-Sided|95.0|-0.26|0.91||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||80 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737233|NCT00472797|3198140|Superiority or Other|||||||0.414|||||||t-test, 2 sided|Paired||Change from Baseline to Extension Visit 3|
1737100|NCT00474175|3197931|Superiority or Other||Treatment difference|0.19||||0.422|2-Sided|95.0|-0.28|0.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737101|NCT00474175|3197931|Superiority or Other||Treatment difference|0.16||||0.581|2-Sided|95.0|-0.41|0.74||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737102|NCT00474175|3197931|Superiority or Other||Treatment difference|0.36||||0.229|2-Sided|95.0|-0.22|0.93||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||70 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737103|NCT00474175|3197931|Superiority or Other||Treatment difference|0.21||||0.376|2-Sided|95.0|-0.26|0.68||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737104|NCT00474175|3197931|Superiority or Other||Treatment difference|0.0||||0.992|2-Sided|95.0|-0.57|0.58||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737105|NCT00474175|3197931|Superiority or Other||Treatment difference|0.21||||0.465|2-Sided|95.0|-0.36|0.79||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||60 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737106|NCT00474175|3197931|Superiority or Other||Treatment difference|0.01||||0.955|2-Sided|95.0|-0.44|0.46||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737107|NCT00474175|3197931|Superiority or Other||Treatment difference|0.2||||0.479|2-Sided|95.0|-0.35|0.75||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737108|NCT00474175|3197931|Superiority or Other||Treatment difference|0.21||||0.452|2-Sided|95.0|-0.34|0.76||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||50 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737109|NCT00474175|3197931|Superiority or Other||Treatment difference|0.09||||0.684|2-Sided|95.0|-0.35|0.54||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737110|NCT00474175|3197931|Superiority or Other||Treatment difference|0.37||||0.186|2-Sided|95.0|-0.18|0.92||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737111|NCT00474175|3197931|Superiority or Other||Treatment difference|0.46||||0.099|2-Sided|95.0|-0.09|1.01||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||40 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737112|NCT00474175|3197931|Superiority or Other||Treatment difference|0.27||||0.224|2-Sided|95.0|-0.17|0.71||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737113|NCT00474175|3197931|Superiority or Other||Treatment difference|0.27||||0.316|2-Sided|95.0|-0.26|0.81||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737234|NCT00472797|3198140|Superiority or Other|||||||0.602|||||||t-test, 2 sided|Paired||Mental Component - Change from Baseline to Extension Visit 1|
1737114|NCT00474175|3197931|Superiority or Other||Treatment difference|0.54||||0.047|2-Sided|95.0|0.01|1.08||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||30 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737115|NCT00474175|3197931|Superiority or Other||Treatment difference|0.13||||0.551|2-Sided|95.0|-0.29|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737116|NCT00474175|3197931|Superiority or Other||Treatment difference|0.47||||0.072|2-Sided|95.0|-0.04|0.98||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737117|NCT00474175|3197931|Superiority or Other||Treatment difference|0.6||||0.023|2-Sided|95.0|0.08|1.11||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||25 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737118|NCT00474175|3197931|Superiority or Other||Treatment difference|0.1||||0.647|2-Sided|95.0|-0.32|0.51||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737119|NCT00474175|3197931|Superiority or Other||Treatment difference|0.43||||0.099|2-Sided|95.0|-0.08|0.93||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737120|NCT00474175|3197931|Superiority or Other||Treatment difference|0.52||||0.044|2-Sided|95.0|0.01|1.03||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||20 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737121|NCT00474175|3197931|Superiority or Other||Treatment difference|0.3||||0.131|2-Sided|95.0|-0.09|0.7||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737122|NCT00474175|3197931|Superiority or Other||Treatment difference|0.46||||0.061|2-Sided|95.0|-0.02|0.95||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737123|NCT00474175|3197931|Superiority or Other||Treatment difference|0.77||||0.002|2-Sided|95.0|0.28|1.25||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||15 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737124|NCT00474175|3197931|Superiority or Other||Treatment difference|0.29||||0.119|2-Sided|95.0|-0.07|0.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737125|NCT00474175|3197931|Superiority or Other||Treatment difference|0.49||||0.031|2-Sided|95.0|0.04|0.94||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737126|NCT00474175|3197931|Superiority or Other||Treatment difference|0.78|||<|0.001|2-Sided|95.0|0.33|1.23||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||10 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737127|NCT00474175|3197931|Superiority or Other||Treatment difference|0.38|||<|0.031|2-Sided|95.0|0.03|0.72||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737235|NCT00472797|3198140|Superiority or Other|||||||0.468|||||||t-test, 2 sided|Paired||Mental Component - Baseline to Week 36|
1737128|NCT00474175|3197931|Superiority or Other||Treatment difference|0.55|||<|0.011|2-Sided|95.0|0.13|0.97||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737129|NCT00474175|3197931|Superiority or Other||Treatment difference|0.93|||<|0.001|2-Sided|95.0|0.5|1.35||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||5 minutes: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737130|NCT00474175|3197933|Superiority or Other||Treatment difference|0.26||||0.517|2-Sided|95.0|-0.53|1.06||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737131|NCT00474175|3197933|Superiority or Other||Treatment difference|0.48||||0.332|2-Sided|95.0|-0.49|1.46||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737132|NCT00474175|3197933|Superiority or Other||Treatment difference|0.75||||0.135|2-Sided|95.0|-0.23|1.72||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 120: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737133|NCT00474175|3197933|Superiority or Other||Treatment difference|0.18||||0.358|2-Sided|95.0|-0.2|0.55||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737134|NCT00474175|3197933|Superiority or Other||Treatment difference|0.32||||0.173|2-Sided|95.0|-0.14|0.78||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using ANOVA which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737135|NCT00474175|3197933|Superiority or Other||Treatment difference|0.49||||0.035|2-Sided|95.0|0.03|0.95||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|ANOVA|||SPRID 60: P-value was calculated using Analysis of Variance (ANOVA) which was adjusted for treatment, site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and corresponding 95% C.I. were calculated based on least-squares means from the ANOVA model with treatment, site, and baseline DPS effects.|
1737136|NCT00474175|3197935|Superiority or Other||Hazard Ratio (HR)|1.18||||0.1|2-Sided|95.0|0.97|1.43||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic.|
1737137|NCT00474175|3197935|Superiority or Other||Hazard Ratio (HR)|1.73|||<|0.001|2-Sided|95.0|1.34|2.25||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic.|
1737138|NCT00474175|3197935|Superiority or Other||Hazard Ratio (HR)|2.04|||<|0.001|2-Sided|95.0|1.57|2.66||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Placebo was calculated. C.I. was based on the Wald statistic.|
1737139|NCT00474175|3197936|Superiority or Other||Hazard Ratio (HR)|1.24||||0.03|2-Sided|95.0|1.02|1.51||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 20% relative to the Benzocaine 10% was calculated. C.I. was based on the Wald statistic.|
1737140|NCT00474175|3197936|Superiority or Other||Hazard Ratio (HR)|1.63|||<|0.001|2-Sided|95.0|1.26|2.12||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. HR of Benzocaine 10% relative to the Placebo was calculated. C.I. was based on the Wald statistic.|
1737141|NCT00474175|3197936|Superiority or Other||Hazard Ratio (HR)|2.02|||<|0.001|2-Sided|95.0|1.55|2.64||The a priori threshold p-value was specified as 0.05, and no adjustments were made for multiple comparisons.|Regression, Cox|||P-value was calculated using Cox proportional hazard regression model which was adjusted for treatment, site and baseline DPS. Hazard Ratio (HR) of Benzocaine 20% relative to the Placebo was calculated. C.I. was based on the Wald statistic.|
1737142|NCT00474175|3197937|Superiority or Other||Treatment difference|6.72||||0.047|2-Sided|95.0|0.2|13.3|||Cochran-Mantel-Haenszel|Dose response was considered established if the percentage of responders between the 20% and 10% was greater than or equal to 5%.||P-value was calculated using CMH test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 20% - Benzocaine 10%) and its associated C.I. was calculated based on CMH weighted percentages and the corresponding standard error.|
1737143|NCT00474175|3197937|Superiority or Other||Treatment difference|9.8||||0.038|2-Sided|95.0|0.3|19.3||Alternative hypotheses tested in the study was that benzocaine 10% was significantly (p=<0.05) more effective than placebo provided that benzocaine 20% was more effective than placebo.|Cochran-Mantel-Haenszel|||P-value was calculated using CMH test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 10% - Placebo) and its associated C.I. was calculated based on CMH weighted percentages and the corresponding standard error.|
1737144|NCT00474175|3197937|Superiority or Other||Treatment difference|16.46|||<|0.001|2-Sided|95.0|7.2|25.7||Alternative hypotheses tested in the study was that benzocaine 20% was significantly (p less than or equal to [=<] 0.05) more effective than placebo.|Cochran-Mantel-Haenszel|||P-value was calculated using Cochran-Mantel-Haenszel (CMH) test which was adjusted for site and baseline DPS. Treatment difference (Benzocaine 20% - Placebo) and its associated confidence interval (C.I.) was calculated based on CMH weighted percentages and the corresponding standard error.|
1737145|NCT00474123|3197944|Superiority or Other|||||||0.85|||||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.|
1737146|NCT00474123|3197945|Superiority or Other|||||||0.02|||||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.|
1737147|NCT00474123|3197946|Superiority or Other|||||||0.65|||||||ANCOVA|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.|
1737148|NCT00474123|3197947|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||The sample size was determined as 78 patients. Continuous data were presented as means ± SD, or median (interquartile range) when the distribution was non-normal. For qualitative variables, we presented counts and relative frequencies. For between-group comparison we used multiple regression with adjustment for baseline values of the outcome variable (ANCOVA), or Wilcoxon rank-sum test when the variable had a non-normal distribution.|
1737149|NCT00474058|3197948|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.8842||95.0|-0.29|0.25|||ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.|
1737150|NCT00474058|3197949|Superiority or Other||Mean Difference (Final Values)|-0.41||||0.0301||95.0|-0.79|-0.04|||ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.|
1737151|NCT00474058|3197950|Superiority or Other||Mean Difference (Final Values)|-4.26|||<|0.0001||95.0|-6.08|-2.45||No p-value adjustment was necessary, since a multiple testing in a hierarchical sequentially rejective manner for the primary variable was applied.|ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.|
1737152|NCT00474058|3197951|Superiority or Other||Mean Difference (Final Values)|-3.55||||0.0002||95.0|-5.37|-1.73||No p-value adjustment was necessary, since a multiple test procedure in a hierarchical sequentially rejective manner for the primary variable was applied.|ANCOVA|||Analyses of covariance were performed for the efficacy variables with treatment and (pooled) sites as factors, and baseline value as covariate. Least square means (LS means) for treatment effect were calculated and differences between rotigotine and placebo were presented with 95% confidence intervals (CIs) and p- values.|
1737153|NCT00474045|3197997|Non-Inferiority or Equivalence|Non-inferiority can only be declared if the non-inferiority criterion was fulfilled for both (FAS and Per-protocol) analysis sets. Non-inferiority was declared if the upper limit of the two-sided 95% CI for the estimated treatment difference was below 0.4%.|Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.096||0.122||95.0|-0.34|0.04||P-value for superiority was calculated|Regression, Linear|Treatment, country, preg. status at rand.(fixed factors),HbA1c at rand.(covariate),HbA1c at rand. by preg. status (interaction)|Estimated treatment differences for IDet versus NPH at Visit P4 with the corresponding 95% CI was calculated. Non-inferiority was established but superiority was not established.|Non-inferiority analysis with a null hypothesis stated that the difference between treatments, IDet-NPH, was equal to or larger than the pre-specified non-inferiority margin of 0.4%. In case non-inferiority was established it was also investigated if IDet was superior to NPH with a null hypothesis stating that the difference between IDet and NPH treatment groups is equal to or greater than 0.|
1737169|NCT00473590|3198063|Superiority or Other||Hazard Ratio (HR)|0.743||||0.2804|2-Sided|95.0|0.432|1.276|||Log Rank|The analysis was stratified for number of prior cancer treatments (1, > 1) and β2-microglobulin level (< 3.5, ≥ 3.5 mg/L).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to BORT + P.|The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the BORT + BV group. Stratified Analysis.|
1737170|NCT00473590|3198064|Superiority or Other||Hazard Ratio (HR)|0.608||||0.2634|2-Sided|95.0|0.251|1.468|||Log Rank||The hazard ratios were estimated using Cox regression.|Unstratified analysis|
1737171|NCT00473590|3198064|Superiority or Other||Hazard Ratio (HR)|0.633||||0.3134|2-Sided|95.0|0.258|1.552|||Log Rank||The hazard ratios were estimated using Cox regression. The strata were number of prior cancer treatments (1, > 1) and β2−microglobulin level (< 3.5, ≥ 3.5 mg/L).|Stratified analysis|
1737154|NCT00474045|3197998|Non-Inferiority or Equivalence|Non-inferiority can only be declared if the non-inferiority criterion was fulfilled for both (FAS and Per-protocol) analysis sets. Non-inferiority was declared if the upper limit of the two-sided 95% CI for the estimated treatment difference was below 0.4%.|Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.074||0.4||95.0|-0.21|0.08||P-value for superiority was calculated.|Regression, Linear|Treatment, country, pregnancy (preg.) status at randomisation (random.)-fixed. HbA1c at rand.(covariate) & at rand. by preg. status (interaction)|Estimated treatment differences for IDet versus NPH at Visit P4 with the corresponding 95% confidence interval (CI) was calculated. Non-inferiority was established but superiority was not established.|Non-inferiority analysis with a null hypothesis stated that the difference between treatments, IDet-NPH, was equal to or larger than the pre-specified non-inferiority margin of 0.4%. In case non-inferiority was established it was also investigated if IDet was superior to NPH with a null hypothesis stating that the difference between IDet and NPH treatment groups is equal to or greater than 0.|
1737155|NCT00473889|3197999|Superiority or Other|||||||0.899||||||This is a one sided p-value, which corresponds to the null hypothesis.|Stratified Miettinen and Nurminen|Disease stage and bevacizumab eligibility are the stratification factors in the stratified Miettinen and Nurmimen method.|||
1737156|NCT00473889|3198000|Superiority or Other|||||||0.862||||||This is a one sided p-value, which corresponds to the null hypothesis.|Finkelstein's Interval Censored Method|Disease stage and bevacizumab eligibility are the stratification factors in the Finkelstein's Interval Censored Method Model.|||
1737157|NCT00473889|3198001|Superiority or Other|||||||0.992||||||This is a one sided p-value, which corresponds to the null hypothesis.|Stratified Log Rank|Disease stage and bevacizumab eligibility are the stratification factors in the stratified log rank test.|||
1737158|NCT00473876|3198002|Superiority or Other||Mean Difference (Net)|-4.45|Standard Deviation|10.72||0.034||95.0|||||t-test, 1 sided|Compare between metformin and placebo arm.||Null hypothesis: Metformin has no effect on the ratio between VCO2 (production of CO2) and VE (ventilation), it is also called the VE/VCO2 slope|
1737159|NCT00473876|3198003|Superiority or Other||Mean Difference (Net)|-0.38||||0.08||95.0|||||t-test, 1 sided|The differences between baseline and post-intervention (4 months) was analyzed using independent t-test, comparing metformin and placebo.||Null hypothesis: Metformin has no effect on peak VO2. We targetted 66 subjects and power calculation based on our previous observational study of CHF with insulin resistance with mean peak VO2 of 11.|
1737160|NCT00473694|3198029|Superiority||Estimated Treatment Effect|17.7|||<|0.0001|2-Sided|95.0|12.85|24.38||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.||
1737161|NCT00473694|3198030|Superiority||Estimated Treatment Effect|17.04|||<|0.0001|2-Sided|95.0|13.62|21.31||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.8 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.||
1737162|NCT00473694|3198031|Superiority||Estimated Treatment Effect|18.45|||<|0.0001|2-Sided|95.0|13.98|24.35||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.||
1737163|NCT00473694|3198032|Superiority||Estimated Treatment Effect|15.84|||<|0.0001|2-Sided|95.0|12.58|19.95||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.7 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.||
1737164|NCT00473694|3198033|Superiority||Estimated Treatment Effect|14.86|||<|0.0001|2-Sided|95.0|10.18|21.67||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.||
1737165|NCT00473694|3198034|Superiority||Estimated Treatment Effect|17.29|||<|0.0001|2-Sided|95.0|13.95|21.42||A two-way ANOVA model was used with the logarithm of the recovery time taken as the response variable, and trial site and treatment group were the factors of the model.|ANOVA||The value for estimated treatment effect represents how many times faster the mean time to recovery of the T4/T1 ratio to 0.9 was for participants receiving sugammadex after NMB compared to participants receiving neostigmine after NMB.||
1737166|NCT00473668|3198049|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (<) 10%.|Difference in anti-PRP SPR rate|0.0|||||2-Sided|95.0|-4.16|3.99||||||Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.|
1737167|NCT00473668|3198049|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if upper limit (UL) of the two-sided 95% confidence interval (CI) for the differences between the two groups in terms of anti-PRP seroprotection (SPR) rates was below (<) 10%.|Difference in anti-PRP SPR rate|-1.18|||||2-Sided|95.0|-6.39|2.84||||||Demonstration of the non-inferiority of Tritanrix™-HepB/Hiberix™ Kft. vaccine compared to Tritanrix™-HepB/Hiberix™ vaccine with respect to the anti-PRP antibody response, after a three-dose primary vaccination course.|
1737168|NCT00473590|3198063|Superiority or Other||Hazard Ratio (HR)|0.713||||0.2009|2-Sided|95.0|0.424|1.2|||Log Rank||Hazard ratio relative to BORT + P was estimated using Cox regression.|Unstratified Analysis.|
1737236|NCT00472797|3198140|Superiority or Other|||||||0.002|||||||t-test, 2 sided|Paired||Mental Component - Baseline to Week 12|
1737173|NCT00473590|3198065|Superiority or Other||Hazard Ratio (HR)|0.956||||0.9179|2-Sided|95.0|0.404|2.261|||Log Rank|The strata were number of prior cancer treatments (1, > 1) and β2−microglobulin level (< 3.5, ≥ 3.5 mg/L).|The hazard ratios were estimated using Cox regression.|Stratified analysis|
1737174|NCT00473382|3198103|Superiority or Other||Mean Difference (Final Values)|-1.3|||<|0.0001|2-Sided|95.0|-1.6|-1.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.|
1737175|NCT00473382|3198103|Superiority or Other||Mean Difference (Final Values)|-0.9|||<|0.0001|2-Sided|95.0|-1.3|-0.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.|
1737176|NCT00473382|3198104|Superiority or Other||Difference in percentage at Month 24|28.3|||<|0.0001|2-Sided|95.0|20.2|36.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.||
1737177|NCT00473382|3198104|Superiority or Other||Difference in percentage at Month 24|14.0|||<|0.0002|2-Sided|95.0|6.8|21.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.||
1737178|NCT00473382|3198105|Superiority or Other||Difference in percentage at Month 24|-5.8||||0.0073|2-Sided|95.0|-9.8|-1.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.|
1737179|NCT00473382|3198105|Superiority or Other||Difference in percentage at Month 24|-4.3||||0.0853|2-Sided|95.0|-9.3|0.8||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.|
1737180|NCT00473382|3198106|Superiority or Other||Mean Difference (Final Values)|-132.2|||<|0.0001|2-Sided|95.0|-169.7|-94.8||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737181|NCT00473382|3198106|Superiority or Other||Mean Difference (Final Values)|-111.8|||<|0.0001|2-Sided|95.0|-151.6|-72.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737237|NCT00472797|3198140|Superiority or Other|||||||0.036|||||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Exisit Visit LOCF|
1737182|NCT00473382|3198107|Superiority or Other||Mean Difference (Final Values)|11.2||||0.0005|2-Sided|95.0|5.1|17.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.|
1737183|NCT00473382|3198107|Superiority or Other||Mean Difference (Final Values)|8.3||||0.0102|2-Sided|95.0|2.0|14.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.|
1737184|NCT00473382|3198108|Superiority or Other||Difference in percentage at Month 24|4.5||||0.1384|2-Sided|95.0|-1.2|10.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737185|NCT00473382|3198108|Superiority or Other||Difference in percentage at Month 24|7.1||||0.0119|2-Sided|95.0|1.7|12.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737186|NCT00473382|3198109|Superiority or Other||Difference in percentage at Month 24|27.1|||<|0.0001|2-Sided|95.0|16.4|37.9||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737187|NCT00473382|3198109|Superiority or Other||Difference in percentage at Month 24|21.4|||<|0.0002|2-Sided|95.0|10.8|31.9||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737188|NCT00473382|3198110|Superiority or Other||Mean Difference (Final Values)|9.9|||<|0.0001|2-Sided|95.0|6.4|13.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737238|NCT00472797|3198140|Superiority or Other|||||||0.004|||||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Extension Visit 3|
1737239|NCT00472797|3198140|Superiority or Other|||||||0.001|||||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Extension Visit 1|
1737240|NCT00472797|3198140|Superiority or Other|||||||0.234|||||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Week 36|
1737999|NCT00467038|3198910|Superiority or Other||||||<|0.004|||||||t-test, 1 sided|<0.004 p value was common for all time points.|||
1737189|NCT00473382|3198110|Superiority or Other||Mean Difference (Final Values)|8.5|||<|0.0001|2-Sided|95.0|5.4|11.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737190|NCT00473382|3198111|Superiority or Other||Difference in percentage at Month 24|33.3|||<|0.0001|2-Sided|95.0|23.8|42.8||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.||
1737191|NCT00473382|3198111|Superiority or Other||Difference in percentage at Month 24|20.8|||<|0.0001|2-Sided|95.0|11.4|30.2||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.||
1737192|NCT00473330|3198116|Superiority or Other||Mean Difference (Final Values)|-1.1|||<|0.0001|2-Sided|95.0|-1.5|-0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.|
1737193|NCT00473330|3198116|Superiority or Other||Mean Difference (Final Values)|-1.0|||<|0.0001|2-Sided|95.0|-1.4|-0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.|
1737194|NCT00473330|3198117|Superiority or Other||Difference in percentage at Month 24|24.2|||<|0.0001|2-Sided|95.0|16.7|31.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.||
1737195|NCT00473330|3198117|Superiority or Other||Difference in percentage at Month 24|29.5|||<|0.0001|2-Sided|95.0|21.1|38.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.||
1737196|NCT00473330|3198118|Superiority or Other||Difference in percentage at Month 24|-2.5||||0.2721|2-Sided|95.0|-6.5|1.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.|
1737197|NCT00473330|3198118|Superiority or Other||Difference in percentage at Month 24|-3.0||||0.159|2-Sided|95.0|-6.7|0.7||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.|
1737198|NCT00473330|3198119|Superiority or Other||Mean Difference (Final Values)|-119.1|||<|0.0001|2-Sided|95.0|-159.6|-78.5||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737199|NCT00473330|3198119|Superiority or Other||Mean Difference (Final Values)|-107.9|||<|0.0001|2-Sided|95.0|-149.2|-66.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANCOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737200|NCT00473330|3198120|Superiority or Other||Mean Difference (Final Values)|8.2||||0.0011|2-Sided|95.0|3.3|13.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.|
1737201|NCT00473330|3198120|Superiority or Other||Mean Difference (Final Values)|9.7||||0.0005|2-Sided|95.0|4.3|15.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here.|
1737202|NCT00473330|3198121|Superiority or Other||Difference in percentage at Month 24|7.8||||0.0126|2-Sided|95.0|2.0|13.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737203|NCT00473330|3198121|Superiority or Other||Difference in percentage at Month 24|8.2||||0.0086|2-Sided|95.0|2.4|14.1||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737204|NCT00473330|3198122|Superiority or Other||Difference in percentage at Month 24|25.1|||<|0.0001|2-Sided|95.0|14.0|36.3||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737241|NCT00472797|3198140|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|Paired||Physical Component - Change from Baseline to Week 12|
1737242|NCT00472797|3198141|Superiority or Other|||||||0.899||||||P-value denotes differences between treatment groups in change in diameter of injection site redness from baseline to week 12.|ANOVA|||Analysis evaluates differences between treatment groups in change in diameter of injection site redness from baseline to week 12.|
1737243|NCT00472797|3198143|Superiority or Other|||||||0.302||||||P-value refers to differneces in total score from baseline to week 12 between treatment groups.|ANOVA|||Analysis evaluates total score from baseline to week 12 for differences between each treatment group.|
1742904|NCT00420927|3205872|Superiority or Other|||||||0.241|||||||Regression, Logistic||||
1737205|NCT00473330|3198122|Superiority or Other||Difference in percentage at Month 24|24.4|||<|0.0001|2-Sided|95.0|13.4|35.4||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.|The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737206|NCT00473330|3198123|Superiority or Other||Mean Difference (Final Values)|9.4|||<|0.0001|2-Sided|95.0|6.2|12.6||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737207|NCT00473330|3198123|Superiority or Other||Mean Difference (Final Values)|9.6|||<|0.0001|2-Sided|95.0|6.1|13.0||To manage the type I error rate while testing multiple secondary efficacy endpoints for statistical significance, a type I error management plan was implemented. Secondary endpoints were prioritized and tested using a hierarchical testing procedure.|ANOVA|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).||The analysis summarized in this section is for the Month 24 time point, comparing the outcome for patients randomized to ranibizumab versus sham injections during the controlled treatment period. The statistical analysis for the Outcome Measure at Month 36 is not shown here. The statistical analysis was not performed at Month 48.|
1737208|NCT00473330|3198124|Superiority or Other||Difference in percentage at Month 24|20.9||||0.0002|2-Sided|95.0|10.7|31.1||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.||
1737209|NCT00473330|3198124|Superiority or Other||Difference in percentage at Month 24|24.3|||<|0.0001|2-Sided|95.0|13.8|34.8||An adjustment was made for multiple treatment comparisons of the ranibizumab dose groups with the control group.|Cochran-Mantel-Haenszel|The analysis was stratified by baseline BCVA score (≤55, >55 letters), baseline HbA1c (≤8%, >8%), and prior therapy for ME in the study eye (yes, no).|The percentage for each group and the difference in percentage between groups were estimated using the weighted average of the observed percentages and the differences in observed percentages over the strata using the Cochran-Mantel-Haenszel weights.||
1737210|NCT00473083|3198132|Superiority or Other|||||||0.0147|||||||Wilcoxon (Mann-Whitney)||||
1737211|NCT00473083|3198134|Superiority or Other|||||||0.3834|||||||Log Rank||||
1737212|NCT00473083|3198135|Superiority or Other|||||||0.0344|||||||Chi-squared|||Maximal Severity Grade 3|
1737213|NCT00473083|3198135|Superiority or Other|||||||0.0882|||||||Chi-squared|||Maximal Severity Grade 2b|
1737214|NCT00473083|3198135|Superiority or Other|||||||0.1921|||||||Chi-squared|||Maximal Severity Grade 2a|
1737215|NCT00473083|3198135|Superiority or Other|||||||0.5898|||||||Chi-squared|||Maximal Severity Grade 1|
1737216|NCT00473083|3198135|Superiority or Other|||||||0.0065|||||||Chi-squared|||Maximal Severity Grade 3|
1737217|NCT00473083|3198135|Superiority or Other|||||||0.6759|||||||Chi-squared|||Maximal Severity Grade 2b|
1737218|NCT00473083|3198135|Superiority or Other|||||||0.0464|||||||Chi-squared|||Maximal Severity Grade 2a|
1737219|NCT00473083|3198135|Superiority or Other|||||||0.9072|||||||Chi-squared|||Maximal Severity Grade 1|
1737220|NCT00473083|3198135|Superiority or Other|||||||0.5004|||||||Chi-squared|||Maximal Severity Grade 3|
1737221|NCT00473083|3198135|Superiority or Other|||||||0.2123|||||||Chi-squared|||Maximal Severity Grade 2b|
1737222|NCT00473083|3198135|Superiority or Other|||||||0.474|||||||Chi-squared|||Maximal Rash Grade 2a|
1737223|NCT00473083|3198135|Superiority or Other|||||||0.5097|||||||Chi-squared|||Maximal Rash Grade 1|
1737224|NCT00473083|3198136|Superiority or Other|||||||0.285||||||P(arm 1 v arm 3) in patients with maximum severity of rash grade 3|Wilcoxon (Mann-Whitney)||||
1737225|NCT00473083|3198136|Superiority or Other||||||>|0.9999||||||"P(arm 2 v arm 3) in patients with maximum severity of rash grade 3.~P-value was calculated to be >0.9999 using the Wilcoxon Rank Sumtest by comparing between the two treatment arms."|Wilcoxon (Mann-Whitney)||||
1737226|NCT00473083|3198136|Superiority or Other||||||>|0.1658||||||P(arm 1 v arm 2) in patients with maximum severity of rash grade 3|Wilcoxon (Mann-Whitney)||||
1737227|NCT00473083|3198136|Superiority or Other||||||>|0.0196||||||P(arm 1 v arm 3) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)||||
1737228|NCT00473083|3198136|Superiority or Other||||||>|0.4681||||||P(arm2 v arm3) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)||||
1737229|NCT00473083|3198136|Superiority or Other||||||>|0.1503||||||P(arm 1 v arm 2) in patients with maximum severity of rash grade 1, 2a, or 2b|Wilcoxon (Mann-Whitney)||||
1737230|NCT00473083|3198137|Superiority or Other|||||||0.147||||||P for arm 1 v arms 2 and 3 combined|Wilcoxon (Mann-Whitney)||||
1737231|NCT00473083|3198137|Superiority or Other|||||||0.8769||||||P for arm 1 v arms 2 and 3 combined|Chi-squared||||
1737232|NCT00472797|3198140|Superiority or Other|||||||0.991|||||||t-test, 2 sided|Paired||Change from Baseline to Exit Visit LOCF|
1737244|NCT00472797|3198144|Superiority or Other|||||||0.11||||||P-value refers to differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ.|ANOVA|||Analysis evaluated differences between treatment groups in change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ. Lower scores indicate a more favorable response.|
1737245|NCT00472797|3198144|Superiority or Other||||||<|0.001||||||P-value refers to change in total score from baseline to week 12 for all domains, except global side effect score, in the MSTCQ for all subjects combined.|t-test, 1 sided|Paired t-test for change from baseline to week 12||Change in total score from baseline to week 12 for all subjects combined. Lower scores indicate a more favorable response|
1737246|NCT00472797|3198145|Superiority or Other|||||||0.003||||||P-value denotes the mean percent change from baseline to week 12.|t-test, 1 sided||||
1737247|NCT00472797|3198145|Superiority or Other||||||<|0.001||||||P-value denotes the mean percent change from baseline to week 12.|t-test, 1 sided||||
1737248|NCT00472797|3198145|Superiority or Other||||||<|0.466||||||P-value denotes difference between treatment groups|ANOVA||||
1737249|NCT00472797|3198146|Superiority or Other||mean|2.73|||<|0.001||97.5|2.73|2.73||P-Value denotes percent change from baseline to week 12 for all combined subjects.|t-test, 1 sided|||A one-sided paired t-test across all subjects by combining the titrated and non-titrated new formulation groups was performed.|
1737250|NCT00472732|3198147|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||The null hypothesis predicted that fractional anisotropy, a marker of white matter integrity, would be the same for OTCD patients as for controls.|
1737251|NCT00472732|3198148|Superiority or Other||||||<|0.05||||||This p-value is adjusted for family wise error rate correction.|t-test, 2 sided|||Two-way between-group t-tests restricted to the prefrontal cortex were performed to compare activation during for the 2-Back> 1-Back contrast between OTCD patients and controls.|
1737252|NCT00472732|3198149|Superiority or Other||||||<|0.001||||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of glutamine in parietal white matter would be the same for OTCD patients as for controls.|
1737253|NCT00472732|3198149|Superiority or Other||||||<|0.001||||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of glutamine in posterior cingulate gray matter would be the same for OTCD patients as for controls.|
1737254|NCT00472732|3198149|Superiority or Other||||||<|0.001||||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of myoinositol in parietal white matter will be the same in OTCD patients as in controls.|
1737255|NCT00472732|3198149|Superiority or Other||||||<|0.003||||||The Bonferroni-corrected a priori p-value was 0.007 (a priori alpha=0.05/number of tests=7).|t-test, 2 sided|||The null hypothesis predicted that the concentration of myoinositol in posterior cingulate gray matter will be the same in OTCD patients as in controls.|
1737256|NCT00472641|3198150|Superiority or Other||||||<|1e-05|||||||Random Regression Mixed Effects Modeling||||
1737257|NCT00472641|3198151|Superiority or Other||||||<|1e-05|||||||Random Regression Mixed Effects Modeling||||
1737258|NCT00472576|3198152|Superiority or Other||Mean Difference (Final Values)|-2.04|Standard Error of the Mean|2.479||0.272|2-Sided|95.0|-6.981|2.901||This test is a comparison of the MK-0657 condition to the placebo condition.|Mixed Models Analysis||The primary outcome of interest is whether the groups differ at the end of the study, so the means represent values at that point in time.|A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz’s Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.|
1737259|NCT00472576|3198153|Superiority or Other||Mean Difference (Final Values)|2.291|Standard Error of the Mean|0.693||0.001|2-Sided|95.0|0.911|3.671|||Mixed Models Analysis||Mean differences reflect groups differences at end point.|A linear mixed model with restricted maximum likelihood estimation was used to examine the effects of treatment (MK-0657 and placebo) over time (treatment day) with the baseline of each phase as a covariate. A main effect for phase of study was also included. Schwarz’s Bayesian criteria was used to determine the best fitting variance-covariance structure which was an autoregressive moving average model. Bonferroni adjusted simple effects tests were used to evaluate significant effects.|
1737260|NCT00472446|3198154|Superiority or Other|||||||0.925|||||||non-parametric ANOVA-type statistic|non-parametric ANOVA-type statistic for pooled main effects, full model||null hypothesis: no difference in outcome measure for superficial cervical block versus placebo treatment|
1737261|NCT00472446|3198155|Superiority or Other|||||||0.44|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled metamizole dose"|
1737262|NCT00472446|3198155|Superiority or Other|||||||0.331|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled paracetamol dose"|
1737263|NCT00472446|3198155|Superiority or Other|||||||0.81|||||||Non-parametric ANOVA-type|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: metamizole"|
1737264|NCT00472446|3198155|Superiority or Other|||||||0.328|||||||Non-parametric ANOVA-type|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||"null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: paracetamol"|
1737265|NCT00472446|3198156|Superiority or Other|||||||0.58|||||||Fisher Exact|mid p value of two-sided Fisher test||"null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Metamizole:"|
1738026|NCT00464945|3199210|Superiority or Other||Ratio|0.98||||||95.0|0.81|1.17||||||For serotype 19F the GMC ratio was calculated|
1737266|NCT00472446|3198156|Superiority or Other|||||||0.94|||||||Fisher Exact|mid p value of the two-sided Fisher test||"null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Paracetamol:"|
1737267|NCT00472446|3198158|Superiority or Other|||||||0.723|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||null hypothesis: no difference in outcome measure pre-operative versus post-operative application|
1737268|NCT00472446|3198158|Superiority or Other|||||||0.016|||||||Non-parametric ANOVA-type statistic|Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model||null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)|
1737269|NCT00472446|3198159|Superiority or Other|||||||0.028|||||||t-test, 2 sided|||null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)|
1737270|NCT00472199|3198199|Superiority or Other|||||||0.0022|||||||Mantel Haenszel||||
1737271|NCT00472199|3198201|Superiority or Other||Median Difference (Final Values)|1.0||||0.136|2-Sided|95.0|0.8|1.1|||Wilcoxon (Mann-Whitney)||||
1737272|NCT00472199|3198202|Superiority or Other||Median Difference (Final Values)|0.6||||0.5602|2-Sided|95.0|0.4|0.8|||Wilcoxon (Mann-Whitney)||||
1737273|NCT00472199|3198203|Superiority or Other||Median Difference (Final Values)|6.3||||0.0206|2-Sided|95.0|5.9|6.6|||Wilcoxon (Mann-Whitney)||||
1737274|NCT00472199|3198204|Superiority or Other||Median Difference (Final Values)|0.0||||0.8432|2-Sided|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)||||
1737275|NCT00472199|3198205|Superiority or Other||Median Difference (Final Values)|0.0||||0.5713|2-Sided|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)||||
1737276|NCT00472199|3198206|Superiority or Other||Median Difference (Final Values)|0.0||||0.3131|2-Sided|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)||||
1737277|NCT00472199|3198207|Superiority or Other||Median Difference (Final Values)|0.0||||0.2915|2-Sided|95.0|-0.4|0.4|||Wilcoxon (Mann-Whitney)||||
1737278|NCT00472199|3198208|Superiority or Other||Median Difference (Final Values)|0.0||||0.1456|2-Sided|95.0|-0.3|0.3|||Wilcoxon (Mann-Whitney)||||
1737279|NCT00472199|3198209|Superiority or Other||Median Difference (Final Values)|2.0||||0.545|2-Sided|95.0|1.7|2.3|||Wilcoxon (Mann-Whitney)||||
1737280|NCT00472199|3198210|Superiority or Other||Median Difference (Final Values)|2.0||||0.0179|2-Sided|95.0|1.6|2.4|||Wilcoxon (Mann-Whitney)||||
1737281|NCT00472199|3198211|Superiority or Other||Median Difference (Final Values)|2.5||||0.5905|2-Sided|95.0|2.2|2.8|||Wilcoxon (Mann-Whitney)||||
1737282|NCT00472199|3198212|Superiority or Other||Median Difference (Final Values)|-5.0||||0.0916|2-Sided|95.0|-5.5|-4.5|||Wilcoxon (Mann-Whitney)||||
1737283|NCT00472199|3198213|Superiority or Other||Median Difference (Final Values)|0.0||||0.0583|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||||
1737284|NCT00472199|3198214|Superiority or Other||Median Difference (Final Values)|0.0||||0.8093|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||||
1737285|NCT00472199|3198215|Superiority or Other||Median Difference (Final Values)|0.0||||0.9241|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||||
1737286|NCT00472199|3198216|Superiority or Other||Median Difference (Final Values)|0.0||||0.841|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||||
1737287|NCT00472199|3198217|Superiority or Other||Median Difference (Final Values)|0.0||||0.0735|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||||
1737288|NCT00472199|3198218|Superiority or Other||Median Difference (Final Values)|0.0||||0.0315|2-Sided|95.0|0.0|0.0|||Wilcoxon (Mann-Whitney)||||
1737289|NCT00472199|3198219|Superiority or Other||Median Difference (Final Values)|-1.0||||0.0489||95.0|-1.1|-0.9|||Wilcoxon (Mann-Whitney)||||
1737290|NCT00472199|3198220|Superiority or Other|||||||0.0011|||||||Cochran-Mantel-Haenszel||||
1737291|NCT00472199|3198221|Superiority or Other|||||||0.0044|||||||Cochran-Mantel-Haenszel||||
1737292|NCT00472199|3198222|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1737293|NCT00472199|3198223|Superiority or Other||Mean Difference (Net)|-2.6|Standard Error of the Mean|1.0||0.0077||95.0|-4.6|-0.7|||ANCOVA|||Analysis of covariance for changes from baseline with factors treatment and country and using baseline as covariate|
1737294|NCT00471445|3198258|Superiority or Other||Mean Difference (Final Values)|-0.174|Standard Error of the Mean|0.19||0.363|2-Sided|95.0|-0.548|0.201|||ANCOVA|||Tested at the two-sided 0.05 significance level.|
1737295|NCT00471354|3198260|Superiority or Other||||||<|0.001|||||||Paired t-test||||
1737296|NCT00471354|3198262|Superiority or Other||||||<|0.001|||||||Paired t-test||||
1737297|NCT00471354|3198263|Superiority or Other||||||<|0.001|||||||Paired t-test||||
1737298|NCT00471354|3198264|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline in Total Scores.|Paired t-test||||
1737299|NCT00471354|3198264|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline in Science Scores.|Paired t-test||||
1737300|NCT00471354|3198264|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline in Math Scores.|Paired t-test||||
1737301|NCT00471354|3198264|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline in Language Scores.|Paired t-test||||
1737302|NCT00471354|3198265|Superiority or Other|||||||0.464||||||P-value for Correlation with Science Scores.|Spearman Partial Rank Order Correlation||||
1737303|NCT00471354|3198265|Superiority or Other|||||||0.11||||||P-value for Correlation with Math Scores.|Spearman Partial Rank Order Correlation||||
1737304|NCT00471354|3198265|Superiority or Other|||||||0.276||||||P-value for Correlation with Language Scores|Spearman Partial Rank Order Correlation||||
1737305|NCT00471354|3198266|Superiority or Other|||||||0.293|||||||Spearman Partial Rank Order Correlation||||
1737306|NCT00471276|3198296|Superiority or Other||Objective Response Rate (percent)|10.8|||||2-Sided|95.0|5.1|19.6|||||||
1737307|NCT00471276|3198297|Superiority or Other||Objective Response Rate (percent)|8.4|||||2-Sided|95.0|3.5|16.6|||||||
1737308|NCT00471237|3198310|Superiority||Median Difference (Net)|-1.57|Standard Error of the Mean|0.37||0|2-Sided|95.0|-2.3|-0.84|||ANOVA|||Total Hip aBMD, Month 12|
1737314|NCT00471237|3198310|Superiority||Mean Difference (Net)|-0.79|Standard Error of the Mean|0.33||0.017|2-Sided|95.0|-1.43|-0.14|||ANOVA|||Total Hip aBMD, Month 6|
1737315|NCT00471237|3198310|Superiority||Mean Difference (Net)|-0.68|Standard Error of the Mean|0.33||0.037|2-Sided|95.0|-1.32|-0.04|||ANOVA|||Total Hip aBMD, Month 6|
1737316|NCT00471237|3198311|Superiority||Mean Difference (Net)|0.35|Standard Error of the Mean|0.48||0.68|2-Sided|95.0|-0.59|1.29|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was <0.006 at Month 6.|||
1737317|NCT00471237|3198311|Superiority||Mean Difference (Net)|-0.19|Standard Error of the Mean|0.47||0.68|2-Sided|95.0|-1.12|0.73|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was <0.006 at Month 6.|||
1737318|NCT00471237|3198311|Superiority||Mean Difference (Net)|0.95|Standard Error of the Mean|0.48||0.192|2-Sided|95.0|0.01|1.89|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was <0.006 at Month 6.|||
1737319|NCT00471237|3198311|Superiority||Mean Difference (Net)|-0.45|Standard Error of the Mean|0.47||0.68|2-Sided|95.0|-1.38|0.48|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was <0.006 at Month 6.|||
1737320|NCT00471237|3198319|Superiority||Mean Difference (Net)|1.6|Standard Error of the Mean|0.55||0.012|2-Sided|95.0|0.51|2.69|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was <0.044 at Month 12.|||
1737321|NCT00471237|3198319|Superiority||Mean Difference (Net)|1.58|Standard Error of the Mean|0.54||0.011|2-Sided|95.0|0.51|2.65|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was <0.044 at Month 12.|||
1737322|NCT00471237|3198319|Superiority||Mean Difference (Net)|1.36|Standard Error of the Mean|0.55||0.028|2-Sided|95.0|0.28|2.44|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was <0.044 at Month 12|||
1737323|NCT00471237|3198319|Superiority||Mean Difference (Net)|0.29|Standard Error of the Mean|0.55||0.59|2-Sided|95.0|-0.78|1.37|||ANOVA|Each dose of ronacaleret was deemed significantly different from placebo if the Hommel-adjusted p-value was <0.044 at Month 12.|||
1737324|NCT00471146|3198327|Superiority or Other||Risk Ratio (RR)|3.2||||0.038|2-Sided|95.0|1.0|10.1|||Cochran-Mantel-Haenszel|||Differences in OR between treatment arms was analyzed by 1-sided Cochran-Mantel-Haenszel (CMH) test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).|
1737325|NCT00471146|3198328|Superiority or Other||Hazard Ratio (HR)|1.006||||0.5203|2-Sided|95.0|0.779|1.298||One-sided log-rank test at alpha = 0.025 significance level was used.The p-value was not adjusted for multiple testing.|Log Rank|||Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).|
1737326|NCT00471146|3198329|Superiority or Other||Hazard Ratio (HR)|1.014||||0.5436|2-Sided|95.0|0.786|1.309||One-sided log-rank test at alpha = 0.025 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).|
1737327|NCT00471107|3198330|Superiority or Other||||||>|0.05|||||||ANOVA|||Power analysis was based on WMS-III Word Lists performance. With an effect comparable to the effect on verbal fluency in an earlier study of left frontal TDCS in healthy subjects, it would require 10 subjects per group (30 total) for a significance level of 0.05 and 80% power.|
1737328|NCT00471081|3198347|Superiority||Percentage of subjects with hSBA titers|99.3|||||2-Sided|95.0|96.2|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup Y.|
1737329|NCT00471081|3198347|Superiority||Percentage of subjects with hSBA titers|99.3|||||2-Sided|95.0|96.2|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup W-135.|
1737330|NCT00471081|3198347|Superiority||Percentage of subjects with hSBA titers|100.0|||||2-Sided|95.0|97.3|100.0|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 90%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup C.|
1737331|NCT00471081|3198347|Superiority||Percentage of subjects with hSBA titers|88.4|||||2-Sided|95.0|81.9|93.2|||||Immunogenecity of GSK134612 was demonstrated if the lower limit (LL) of the 2-sided exact 95% confidence interval (CI) was higher than the pre-defined clinical limit of 80%.|To demonstrate the immunogenicity of GSK134612 administered on a 2-dose schedule at 9 and 12 months of age with respect to serum bactericidal assay using human complement (hSBA) titers ≥1:8 for each discrete N. meningitidis serogroup A.|
1737332|NCT00470834|3198359|Superiority or Other||Relative Risk Reduction|5.62|||||2-Sided|95.0|-46.14|39.05|||||Relative Risk Reduction = 100 * (1 - Relative Risk).||
1737333|NCT00470834|3198359|Superiority or Other||Relative Risk|0.94|||||2-Sided|95.0|0.61|1.46|||||The hazard ratio is based on the Cox proportional hazards model.||
1737334|NCT00470834|3198359|Superiority or Other|||||||0.79|||||||Log Rank||||
1737335|NCT00470626|3198361|Superiority or Other||Probability of Successful Retrieval|0.9||||||95.0|||||||Probability of successful retrieval is from Kaplan-Meier analysis.||
1737336|NCT00470106|3198403|Superiority or Other||||||<|0.1||||||A priori threshold for significance was P < .05|mixed model|Same as for the primary variable.|||
1737337|NCT00470106|3198404|Superiority or Other||||||<|0.001||||||Not corrected for multiple comparisons because it is primary.|mixed model|same analysis as for secondary outcome variable.|||
1737338|NCT00469911|3198415|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1742905|NCT00420927|3205872|Superiority or Other|||||||0.192|||||||Regression, Logistic||||
1737339|NCT00469456|3198433|Superiority or Other||Mean Difference (Final Values)|5.9||||0.022||95.0|0.9|10.9|||ANCOVA|||The secondary efficacy parameter was change from Baseline at Week 12 in the total score of the Social Communication subscale and Communication of Basic Needs subscale of the ASHA FACS. Missing scores at week 12 were imputed using the last-observation-carried-forward (LOCF) approach.|
1737340|NCT00469456|3198434|Superiority or Other||Mean Difference (Final Values)|1.3||||0.07||95.0|-0.1|2.8|||ANCOVA|||The primary efficacy parameter was change from Baseline to Week 12 in FLCI total score. Missing FLCI total scores at Week 12 were imputed using the last-observation-carried-forward (LOCF) approach.|
1737341|NCT00469092|3198441|Superiority or Other||Mean Difference (Net)|-0.11||||||95.0|-2.36|2.14|||||The mean difference and 95% CI is for the overall score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|Diab MedSat measure was scored as an overall score as well as three subscale scores, and transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.|
1737342|NCT00469092|3198441|Superiority or Other||Mean Difference (Net)|-0.39||||||95.0|-3.14|2.35|||||The mean difference and 95% CI is for the symptoms score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.|
1737343|NCT00469092|3198441|Superiority or Other||Mean Difference (Net)|-0.22||||||95.0|-3.56|3.11|||||The mean difference and 95% CI is for the efficacy score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.|
1737344|NCT00469092|3198441|Superiority or Other||Mean Difference (Net)|0.04||||||95.0|-2.4|2.48|||||The mean difference and 95% CI is for the burden score. The scores were compared between the treatment groups by fitting a linear regression model with treatment and country as factors and the baseline values as a continuous covariate.|The Diab MedSat measure was scored as an overall score as well as three subscale scores. The scores were transformed to a 0-100 scale with higher scores indicating greater satisfaction. The score of the subscales was computed as the mean of the items in each subscale. The overall score is the mean of all three subscales.|
1737345|NCT00469092|3198442|Superiority or Other||Odds Ratio (OR)|1.122||||||95.0|0.69|1.82|||||The OR and 95% CI is for the HbA1c < 7%, no hypoglycemia treatment target.||
1737346|NCT00469092|3198442|Superiority or Other||Odds Ratio (OR)|1.181||||||95.0|0.74|1.87|||||The OR and 95% CI is for the HbA1c < 7%, no daytime (06:01-23:59) hypoglycemia treatment target||
1737347|NCT00469092|3198442|Superiority or Other||Odds Ratio (OR)|0.905||||||95.0|0.59|1.38|||||The OR and 95% CI is for the HbA1c < 7% no nocturnal (00:00-06:00) hypoglycemia treatment target||
1737348|NCT00469092|3198442|Superiority or Other||Odds Ratio (OR)|1.131||||||95.0|0.72|1.77|||||The OR and 95% CI is for the reduction more than 1.0% from baseline treatment target.||
1737349|NCT00469092|3198442|Superiority or Other||Odds Ratio (OR)|1.014||||||95.0|0.67|1.54|||||The OR and 95% CI is for the HbA1c < 7.0% treatment target.||
1737350|NCT00469092|3198442|Superiority or Other||Odds Ratio (OR)|0.914||||||95.0|0.57|1.47|||||The OR and 95% CI is for the HbA1c <= 6.5% treatment target.||
1737351|NCT00469092|3198443|Superiority or Other|||||||0.0059||||||P-value for parallelism is overall test for parallel time profiles between treatment groups i.e. time by treatment group interaction effect.|Mixed Models Analysis|||The profiles were compared between the treatment groups by fitting a repeated measures mixed model including treatment, time, the treatment-by-time interaction and country as fixed effects, and subject as random effect.|
1737352|NCT00469092|3198444|Non-Inferiority or Equivalence|Non-inferiority is shown if the upper limit of the 95% CI is less than 0.4%. Furthermore, superiority of BIAsp 30 OD over insulin glargine OD was shown if the upper limit of the 95% CI for the difference is lower than 0%. Equivalence is shown if the upper limit of the 95% CI for the difference is lower than 0.4% and the lower limit of the 95% CI is greater than -0.4%.|Mean Difference (Net)|-0.16||||0.029||95.0|-0.3|-0.02||P-value is for the test for difference in means equals 0 against the alternative that the difference is different from 0.|Regression, Linear|||HbA1c was compared between the treatment groups by fitting a linear regression model (ANCOVA) with treatment and country as factors and the baseline values as a continuous covariate. Mean and SE are estimated from the model.|
1737353|NCT00469079|3198445|Superiority or Other (legacy)||Mean difference between 3 groups|0.0|||>|0.1|2-Sided|95.0|||||Mixed Models Analysis|||A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period. Each repeated-measures model included the treatment effect, a visit effect, the interaction between treatment and visit, the interaction between subject error and within-subject error terms.|
1737354|NCT00469079|3198446|Superiority or Other (legacy)||Other|0.0|||<|0.05|2-Sided|95.0|||||Mixed Models Analysis|A generalized linear mixed model was used for outcomes that had been repeatedly measured from baseline through the end of the treatment period.||This study was not powered to detect differences in smoking cessation rates between groups; however, smoking status was collected to obtain preliminary data. Point prevalence (no smoking during the previous 7 days) cigarette abstinence rates were calculated at the week-4 visit and at each of the 2 follow-up visits. Continuous abstinence rates were calculated for the 4 week period between the week 1 and week 4 visits. Abstinence at all visits was assessed by self-report and confirmed by CO.|
1737355|NCT00469079|3198447|Superiority or Other (legacy)|||||||0.05|||||||Mixed Models Analysis|||Product use is by self-report and daily diaries.|
1737356|NCT00469079|3198448|Superiority or Other (legacy)|||||||0.002|||||||Mixed Models Analysis||||
1737357|NCT00468910|3198453|Superiority or Other|||||||0.17|||||||Wilcoxon (Mann-Whitney)||||
1743513|NCT00413283|3206866|Superiority or Other|||||||0.199|||||||Satterthwaite t-test||||
1737358|NCT00468910|3198454|Superiority or Other|||||||0.11|||||||Wilcoxon (Mann-Whitney)|||The study was powered to detect an attributable change in the aspirin group of 50% relative to baseline values - an approximate 50% increase in spectral slope.|
1737359|NCT00468845|3198464|Superiority or Other|||||||0.6978|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28|
1737360|NCT00468845|3198464|Superiority or Other|||||||0.0104|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28|
1737361|NCT00468845|3198464|Superiority or Other|||||||0.303|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14|
1737362|NCT00468845|3198464|Superiority or Other|||||||0.4951|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14|
1737363|NCT00468845|3198464|Superiority or Other|||||||0.0463|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7|
1737364|NCT00468845|3198464|Superiority or Other|||||||0.7804|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7|
1737365|NCT00468845|3198464|Superiority or Other|||||||0.7597|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737366|NCT00468845|3198464|Superiority or Other|||||||0.6009|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737367|NCT00468845|3198464|Superiority or Other|||||||0.4035|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS;|
1737368|NCT00468845|3198464|Superiority or Other|||||||0.809|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS;|
1737369|NCT00468845|3198464|Superiority or Other|||||||0.7948|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS;|
1737370|NCT00468845|3198464|Superiority or Other|||||||0.3343|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS;|
1737371|NCT00468845|3198464|Superiority or Other|||||||0.1351|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS;|
1737372|NCT00468845|3198464|Superiority or Other|||||||0.3838|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS;|
1737373|NCT00468845|3198464|Superiority or Other|||||||0.9343|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS;|
1737374|NCT00468845|3198464|Superiority or Other|||||||0.6003|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS;|
1737375|NCT00468845|3198464|Superiority or Other|||||||0.4929|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS;|
1737376|NCT00468845|3198464|Superiority or Other|||||||0.4132|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS;|
1737377|NCT00468845|3198464|Superiority or Other|||||||0.7347|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day;|
1737378|NCT00468845|3198464|Superiority or Other|||||||0.9463|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day;|
1737379|NCT00468845|3198465|Superiority or Other|||||||0.6262|||||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 6 PS.|
1737380|NCT00468845|3198465|Superiority or Other|||||||0.3566|||||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 6 PS.|
1737381|NCT00468845|3198465|Superiority or Other|||||||0.1334|||||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 3 PS.|
1737382|NCT00468845|3198465|Superiority or Other|||||||0.9877|||||||Cochran-Mantel-Haenszel|p-values are derived from CMH test adjusted for pooled centers and salpingo-oophorectomy strata||Incidence of chronic PS pain at Month 3 PS.|
1737383|NCT00468845|3198466|Superiority or Other|||||||0.1464|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paresthesia/dysesthesia|
1737384|NCT00468845|3198466|Superiority or Other|||||||0.0075|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paresthesia/dysesthesia|
1737385|NCT00468845|3198466|Superiority or Other|||||||0.9942|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Evoked Pain subscale|
1737386|NCT00468845|3198466|Superiority or Other|||||||0.55|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Evoked Pain subscale|
1737387|NCT00468845|3198466|Superiority or Other|||||||0.2722|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paroxysmal pain subscale|
1737388|NCT00468845|3198466|Superiority or Other|||||||0.6215|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Paroxysmal pain subscale|
1737389|NCT00468845|3198466|Superiority or Other|||||||0.8843|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Pressing Spontaneous subscale|
1737390|NCT00468845|3198466|Superiority or Other|||||||0.432|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Pressing Spontaneous subscale|
1737391|NCT00468845|3198466|Superiority or Other|||||||0.8696|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Burning Spontaneous subscale|
1737392|NCT00468845|3198466|Superiority or Other|||||||0.7078|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Burning Spontaneous subscale|
1737393|NCT00468845|3198466|Superiority or Other|||||||0.3687|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Total subscale|
1737394|NCT00468845|3198466|Superiority or Other|||||||0.6211|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Total subscale|
1737395|NCT00468845|3198467|Superiority or Other|||||||0.1565|||||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;|
1737396|NCT00468845|3198467|Superiority or Other|||||||0.7889|||||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;|
1737397|NCT00468845|3198468|Superiority or Other|||||||0.4425|||||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;|
1737398|NCT00468845|3198468|Superiority or Other|||||||0.7218|||||||Log Rank|||Kaplan-Meier method was used for survival distribution estimation;|
1737399|NCT00468845|3198469|Superiority or Other|||||||0.8364|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Day 28|
1737400|NCT00468845|3198469|Superiority or Other|||||||0.1663|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Day 28|
1737401|NCT00468845|3198469|Superiority or Other|||||||0.4047|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Discharge|
1737402|NCT00468845|3198469|Superiority or Other|||||||0.5609|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 2001 Discharge|
1737403|NCT00468845|3198469|Superiority or Other|||||||0.9135|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Day 28|
1737404|NCT00468845|3198469|Superiority or Other|||||||0.1008|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Day 28|
1737405|NCT00468845|3198469|Superiority or Other|||||||0.2214|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Discharge|
1737406|NCT00468845|3198469|Superiority or Other|||||||0.8914|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||EQ-5D 1997 Discharge|
1737407|NCT00468845|3198470|Superiority or Other|||||||0.865|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28|
1737408|NCT00468845|3198470|Superiority or Other|||||||0.009|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28|
1737409|NCT00468845|3198470|Superiority or Other|||||||0.0112|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737410|NCT00468845|3198470|Superiority or Other|||||||0.9712|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737411|NCT00468845|3198471|Superiority or Other|||||||0.4531|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Day 28|
1737412|NCT00468845|3198471|Superiority or Other|||||||0.055|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Day 28|
1737413|NCT00468845|3198471|Superiority or Other|||||||0.6404|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Discharge|
1737414|NCT00468845|3198471|Superiority or Other|||||||0.284|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Efficacy at Discharge|
1737415|NCT00468845|3198471|Superiority or Other|||||||0.4345|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Day 28|
1737416|NCT00468845|3198471|Superiority or Other|||||||0.095|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Day 28|
1737417|NCT00468845|3198471|Superiority or Other|||||||0.2234|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Discharge|
1737418|NCT00468845|3198471|Superiority or Other|||||||0.1729|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Characteristics at Discharge|
1737419|NCT00468845|3198471|Superiority or Other|||||||0.3647|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Day 28|
1737420|NCT00468845|3198471|Superiority or Other|||||||0.0422|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Day 28|
1737421|NCT00468845|3198471|Superiority or Other|||||||0.3994|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Discharge|
1737422|NCT00468845|3198471|Superiority or Other|||||||0.1872|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Medication Subscale at Discharge|
1737423|NCT00468845|3198472|Superiority or Other|||||||0.227|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 28|
1737424|NCT00468845|3198472|Superiority or Other|||||||0.0287|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 28|
1737425|NCT00468845|3198473|Superiority or Other|||||||0.3506|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours|
1737426|NCT00468845|3198475|Superiority or Other|||||||0.0011|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 14|
1737427|NCT00468845|3198475|Superiority or Other|||||||0.0206|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 14|
1737428|NCT00468845|3198476|Superiority or Other|||||||0.0797|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 7|
1737429|NCT00468845|3198476|Superiority or Other|||||||0.0361|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 7|
1737430|NCT00468845|3198477|Superiority or Other|||||||0.1666|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Discharge|
1738027|NCT00464945|3199210|Superiority or Other||Ratio|1.06||||||95.0|0.86|1.3||||||For serotype 18C the GMC ratio was calculated|
1737431|NCT00468845|3198477|Superiority or Other|||||||0.1233|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Discharge|
1737432|NCT00468845|3198478|Superiority or Other|||||||1|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 5 PS|
1737433|NCT00468845|3198478|Superiority or Other|||||||0.9126|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 5 PS|
1737434|NCT00468845|3198479|Superiority or Other|||||||0.9013|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 4 PS|
1737435|NCT00468845|3198479|Superiority or Other|||||||0.6715|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 4 PS|
1737436|NCT00468845|3198480|Superiority or Other|||||||0.5154|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 3 PS|
1737437|NCT00468845|3198480|Superiority or Other|||||||0.7418|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 3 PS|
1737438|NCT00468845|3198481|Superiority or Other|||||||0.4455|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 2 PS|
1737439|NCT00468845|3198481|Superiority or Other|||||||0.0714|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 2 PS|
1737440|NCT00468845|3198482|Superiority or Other|||||||0.3045|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 1 PS|
1737441|NCT00468845|3198482|Superiority or Other|||||||0.4264|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Day 1 PS|
1737442|NCT00468845|3198483|Superiority or Other|||||||0.9905|||||||Cochran-Mantel-Haenszel|CMH test adjusted for pooled centers and salpingo-oophorectomy strata.||Surgery Day|
1737443|NCT00468845|3198483|Superiority or Other|||||||0.6861|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusted for pooled centers and salpingo-oophorectomy strata.||Surgery Day|
1737444|NCT00468845|3198486|Superiority or Other|||||||0.2983|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28|
1737445|NCT00468845|3198486|Superiority or Other|||||||0.7833|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28|
1737446|NCT00468845|3198486|Superiority or Other|||||||0.9366|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14|
1737447|NCT00468845|3198486|Superiority or Other|||||||0.0214|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14|
1737448|NCT00468845|3198486|Superiority or Other|||||||0.8741|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7|
1737449|NCT00468845|3198486|Superiority or Other|||||||0.5094|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7|
1737450|NCT00468845|3198486|Superiority or Other|||||||0.689|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737451|NCT00468845|3198486|Superiority or Other|||||||0.6295|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737452|NCT00468845|3198489|Superiority or Other|||||||0.6923|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28|
1737453|NCT00468845|3198489|Superiority or Other|||||||0.1752|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28|
1737454|NCT00468845|3198489|Superiority or Other|||||||0.187|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14|
1737455|NCT00468845|3198489|Superiority or Other|||||||0.0159|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14|
1737456|NCT00468845|3198489|Superiority or Other|||||||0.0881|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7|
1737457|NCT00468845|3198489|Superiority or Other|||||||0.0271|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7|
1737458|NCT00468845|3198489|Superiority or Other|||||||0.2784|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge;|
1737459|NCT00468845|3198489|Superiority or Other|||||||0.1975|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge;|
1737460|NCT00468845|3198490|Superiority or Other|||||||0.0703|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)|
1737461|NCT00468845|3198490|Superiority or Other|||||||0.7915|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)|
1737462|NCT00468845|3198490|Superiority or Other|||||||0.1187|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)|
1737463|NCT00468845|3198490|Superiority or Other|||||||0.9584|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)|
1737464|NCT00468845|3198490|Superiority or Other|||||||0.3755|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)|
1737465|NCT00468845|3198490|Superiority or Other|||||||0.3243|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)|
1737466|NCT00468845|3198490|Superiority or Other|||||||0.8296|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS|
1737467|NCT00468845|3198490|Superiority or Other|||||||0.2443|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS|
1737468|NCT00468845|3198490|Superiority or Other|||||||0.5078|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS|
1737469|NCT00468845|3198490|Superiority or Other|||||||0.1718|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS|
1737470|NCT00468845|3198490|Superiority or Other|||||||0.3544|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS|
1737471|NCT00468845|3198490|Superiority or Other|||||||0.1829|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS|
1737472|NCT00468845|3198490|Superiority or Other|||||||0.8517|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS|
1737473|NCT00468845|3198490|Superiority or Other|||||||0.4793|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS|
1737474|NCT00468845|3198490|Superiority or Other|||||||0.4592|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS|
1737475|NCT00468845|3198490|Superiority or Other|||||||0.9538|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS|
1737476|NCT00468845|3198490|Superiority or Other|||||||0.5662|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS|
1737477|NCT00468845|3198490|Superiority or Other|||||||0.3323|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS|
1737478|NCT00468845|3198491|Superiority or Other|||||||0.1419|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28|
1737479|NCT00468845|3198491|Superiority or Other|||||||0.3682|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28|
1737480|NCT00468845|3198491|Superiority or Other|||||||0.7916|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14|
1737481|NCT00468845|3198491|Superiority or Other|||||||0.0045|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14|
1737482|NCT00468845|3198491|Superiority or Other|||||||0.7021|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7|
1737483|NCT00468845|3198491|Superiority or Other|||||||0.3808|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7|
1737484|NCT00468845|3198491|Superiority or Other|||||||0.6742|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737485|NCT00468845|3198491|Superiority or Other|||||||0.7511|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737486|NCT00468845|3198492|Superiority or Other|||||||0.0917|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)|
1737487|NCT00468845|3198492|Superiority or Other|||||||0.8079|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS (Average)|
1737488|NCT00468845|3198492|Superiority or Other|||||||0.1056|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)|
1737489|NCT00468845|3198492|Superiority or Other|||||||0.7637|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS (Average)|
1737490|NCT00468845|3198492|Superiority or Other|||||||0.1133|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)|
1737491|NCT00468845|3198492|Superiority or Other|||||||0.6479|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS (Average)|
1737492|NCT00468845|3198492|Superiority or Other|||||||0.5336|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS|
1737493|NCT00468845|3198492|Superiority or Other|||||||0.7381|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 7 PS|
1737494|NCT00468845|3198492|Superiority or Other|||||||0.9143|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS|
1737495|NCT00468845|3198492|Superiority or Other|||||||0.501|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 6 PS|
1737496|NCT00468845|3198492|Superiority or Other|||||||0.9689|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS|
1737497|NCT00468845|3198492|Superiority or Other|||||||0.6882|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS|
1737498|NCT00468845|3198492|Superiority or Other|||||||0.7476|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS|
1737499|NCT00468845|3198492|Superiority or Other|||||||0.8237|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS|
1737500|NCT00468845|3198492|Superiority or Other|||||||0.2227|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS|
1737501|NCT00468845|3198492|Superiority or Other|||||||0.5303|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS|
1737502|NCT00468845|3198492|Superiority or Other|||||||0.0606|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS|
1737503|NCT00468845|3198492|Superiority or Other|||||||0.2201|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS|
1737504|NCT00468845|3198493|Superiority or Other|||||||0.0746|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737505|NCT00468845|3198493|Superiority or Other|||||||0.4065|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737506|NCT00468845|3198493|Superiority or Other|||||||0.1717|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS|
1737507|NCT00468845|3198493|Superiority or Other|||||||0.8766|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS|
1737508|NCT00468845|3198493|Superiority or Other|||||||0.6204|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS|
1737509|NCT00468845|3198493|Superiority or Other|||||||0.7615|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS|
1737510|NCT00468845|3198493|Superiority or Other|||||||0.5615|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS|
1737511|NCT00468845|3198493|Superiority or Other|||||||0.4401|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS|
1737512|NCT00468845|3198493|Superiority or Other|||||||0.1014|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS|
1737513|NCT00468845|3198493|Superiority or Other|||||||0.2616|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS|
1737514|NCT00468845|3198493|Superiority or Other|||||||0.1808|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS|
1737515|NCT00468845|3198493|Superiority or Other|||||||0.6966|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS|
1737516|NCT00468845|3198494|Superiority or Other|||||||0.5119|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||128 hours PS|
1737517|NCT00468845|3198494|Superiority or Other|||||||0.6046|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||128 hours PS|
1737518|NCT00468845|3198494|Superiority or Other|||||||0.9367|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS|
1737519|NCT00468845|3198494|Superiority or Other|||||||0.7071|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS|
1737520|NCT00468845|3198494|Superiority or Other|||||||0.1929|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||112 hours PS|
1737521|NCT00468845|3198494|Superiority or Other|||||||0.8266|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||112 hours PS|
1737522|NCT00468845|3198494|Superiority or Other|||||||0.683|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||104 hours PS|
1737523|NCT00468845|3198494|Superiority or Other|||||||0.5925|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||104 hours PS|
1737524|NCT00468845|3198494|Superiority or Other|||||||0.8045|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS|
1737525|NCT00468845|3198494|Superiority or Other|||||||0.7439|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS|
1737526|NCT00468845|3198494|Superiority or Other|||||||0.4869|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||88 hours PS|
1737527|NCT00468845|3198494|Superiority or Other|||||||0.9711|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||88 hours PS|
1737528|NCT00468845|3198494|Superiority or Other|||||||0.5938|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||80 hours PS|
1737529|NCT00468845|3198494|Superiority or Other|||||||0.3234|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||80 hours PS|
1737530|NCT00468845|3198494|Superiority or Other|||||||0.2083|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS|
1737531|NCT00468845|3198494|Superiority or Other|||||||0.6705|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS|
1737532|NCT00468845|3198494|Superiority or Other|||||||0.6107|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||64 hours PS|
1737533|NCT00468845|3198494|Superiority or Other|||||||0.7104|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||64 hours PS|
1737534|NCT00468845|3198494|Superiority or Other|||||||0.201|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||56 hours PS|
1737535|NCT00468845|3198494|Superiority or Other|||||||0.3855|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||56 hours PS|
1737536|NCT00468845|3198494|Superiority or Other|||||||0.044|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS|
1737537|NCT00468845|3198494|Superiority or Other|||||||0.2161|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS|
1737538|NCT00468845|3198494|Superiority or Other|||||||0.8783|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 hours PS|
1737539|NCT00468845|3198494|Superiority or Other|||||||0.8295|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 hours PS|
1737540|NCT00468845|3198494|Superiority or Other|||||||0.4371|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 hours PS|
1737541|NCT00468845|3198494|Superiority or Other|||||||0.2994|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 hours PS|
1737542|NCT00468845|3198494|Superiority or Other|||||||0.4507|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS|
1737543|NCT00468845|3198494|Superiority or Other|||||||0.8884|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS|
1737544|NCT00468845|3198494|Superiority or Other|||||||0.9981|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 hours PS|
1737545|NCT00468845|3198494|Superiority or Other|||||||0.8261|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 hours PS|
1737546|NCT00468845|3198494|Superiority or Other|||||||0.1005|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 hours PS|
1737547|NCT00468845|3198494|Superiority or Other|||||||0.5682|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 hours PS|
1737548|NCT00468845|3198495|Superiority or Other|||||||0.2133|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge|
1737549|NCT00468845|3198495|Superiority or Other|||||||0.4303|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge|
1737550|NCT00468845|3198495|Superiority or Other|||||||0.7359|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS|
1737551|NCT00468845|3198495|Superiority or Other|||||||0.3024|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS|
1737552|NCT00468845|3198495|Superiority or Other|||||||0.8641|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS|
1737553|NCT00468845|3198495|Superiority or Other|||||||0.3214|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS|
1737554|NCT00468845|3198495|Superiority or Other|||||||0.9192|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS|
1737555|NCT00468845|3198495|Superiority or Other|||||||0.231|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS|
1737556|NCT00468845|3198495|Superiority or Other|||||||0.7243|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS|
1737557|NCT00468845|3198495|Superiority or Other|||||||0.1022|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS|
1737558|NCT00468845|3198495|Superiority or Other|||||||0.7145|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS|
1737559|NCT00468845|3198495|Superiority or Other|||||||0.2209|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS|
1737560|NCT00468845|3198495|Superiority or Other|||||||0.5899|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS|
1737561|NCT00468845|3198495|Superiority or Other|||||||0.4306|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS|
1737562|NCT00468845|3198495|Superiority or Other|||||||0.5938|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS|
1737563|NCT00468845|3198495|Superiority or Other|||||||0.894|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS|
1737564|NCT00468845|3198496|Superiority or Other|||||||0.813|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737565|NCT00468845|3198496|Superiority or Other|||||||0.4782|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737566|NCT00468845|3198496|Superiority or Other|||||||0.2908|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS|
1737567|NCT00468845|3198496|Superiority or Other|||||||0.7061|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 5 PS|
1737568|NCT00468845|3198496|Superiority or Other|||||||0.2315|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS|
1737569|NCT00468845|3198496|Superiority or Other|||||||0.952|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 4 PS|
1737570|NCT00468845|3198496|Superiority or Other|||||||0.4814|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS|
1737571|NCT00468845|3198496|Superiority or Other|||||||0.3858|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 3 PS|
1737572|NCT00468845|3198496|Superiority or Other|||||||0.8624|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS|
1737573|NCT00468845|3198496|Superiority or Other|||||||0.6382|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 2 PS|
1737574|NCT00468845|3198496|Superiority or Other|||||||0.3022|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS|
1737575|NCT00468845|3198496|Superiority or Other|||||||0.2008|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 1 PS|
1737576|NCT00468845|3198496|Superiority or Other|||||||0.6949|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (1 hour after dosing)|
1737577|NCT00468845|3198496|Superiority or Other|||||||0.6574|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (1 hour after dosing)|
1737578|NCT00468845|3198496|Superiority or Other|||||||0.1311|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (prior to first dose)|
1737579|NCT00468845|3198496|Superiority or Other|||||||0.6613|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Surgery day (prior to first dose)|
1737580|NCT00468845|3198497|Superiority or Other|||||||0.6021|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge|
1737581|NCT00468845|3198497|Superiority or Other|||||||0.2501|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge|
1737582|NCT00468845|3198497|Superiority or Other|||||||0.9989|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS|
1737583|NCT00468845|3198497|Superiority or Other|||||||0.7365|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||4th Week PS|
1737584|NCT00468845|3198497|Superiority or Other|||||||0.5331|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS|
1737585|NCT00468845|3198497|Superiority or Other|||||||0.8215|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||3rd Week PS|
1737586|NCT00468845|3198497|Superiority or Other|||||||0.2058|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS|
1737587|NCT00468845|3198497|Superiority or Other|||||||0.4269|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||2nd Week PS|
1737588|NCT00468845|3198497|Superiority or Other|||||||0.0354|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS|
1737589|NCT00468845|3198497|Superiority or Other|||||||0.0568|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||1st Week PS|
1737590|NCT00468845|3198497|Superiority or Other|||||||0.1274|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS|
1737591|NCT00468845|3198497|Superiority or Other|||||||0.1229|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS|
1737592|NCT00468845|3198497|Superiority or Other|||||||0.177|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS|
1737593|NCT00468845|3198497|Superiority or Other|||||||0.2177|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS|
1737594|NCT00468845|3198497|Superiority or Other|||||||0.9104|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS|
1737595|NCT00468845|3198497|Superiority or Other|||||||0.5995|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS|
1737596|NCT00468845|3198498|Superiority or Other|||||||0.0387|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48-72 Hours PS|
1737597|NCT00468845|3198498|Superiority or Other|||||||0.2063|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48-72 Hours PS|
1737598|NCT00468845|3198498|Superiority or Other|||||||0.0102|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24-48 Hours PS|
1737599|NCT00468845|3198498|Superiority or Other|||||||0.2438|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24-48 Hours PS|
1737600|NCT00468845|3198498|Superiority or Other|||||||0.1015|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||0-24 Hours PS|
1737601|NCT00468845|3198498|Superiority or Other|||||||0.273|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||0-24 Hours PS|
1737602|NCT00468845|3198499|Superiority or Other|||||||0.0623|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge|
1737603|NCT00468845|3198499|Superiority or Other|||||||0.0398|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Till Discharge|
1737604|NCT00468845|3198499|Superiority or Other|||||||0.0598|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS|
1737605|NCT00468845|3198499|Superiority or Other|||||||0.111|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS|
1737606|NCT00468845|3198499|Superiority or Other|||||||0.1654|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS|
1737607|NCT00468845|3198499|Superiority or Other|||||||0.2409|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS|
1737608|NCT00468845|3198500|Superiority or Other|||||||0.3364|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.|||
1737609|NCT00468845|3198500|Superiority or Other|||||||0.4388|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.|||
1737610|NCT00468845|3198501|Superiority or Other|||||||0.0902|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS|
1737611|NCT00468845|3198501|Superiority or Other|||||||0.8308|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 Hours PS|
1737612|NCT00468845|3198501|Superiority or Other|||||||0.3968|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 Hours PS|
1737613|NCT00468845|3198501|Superiority or Other|||||||0.9659|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||40 Hours PS|
1737614|NCT00468845|3198501|Superiority or Other|||||||0.39|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 Hours PS|
1737615|NCT00468845|3198501|Superiority or Other|||||||0.5088|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||32 Hours PS|
1737616|NCT00468845|3198501|Superiority or Other|||||||0.482|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS|
1737617|NCT00468845|3198501|Superiority or Other|||||||0.5556|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 Hours PS|
1737618|NCT00468845|3198501|Superiority or Other|||||||0.4147|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 Hours PS|
1737619|NCT00468845|3198501|Superiority or Other|||||||0.4053|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||16 Hours PS|
1737620|NCT00468845|3198501|Superiority or Other|||||||0.7602|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 Hour PS|
1737621|NCT00468845|3198501|Superiority or Other|||||||0.2125|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||8 Hours PS|
1737622|NCT00468845|3198502|Superiority or Other|||||||0.8832|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.|||
1737623|NCT00468845|3198502|Superiority or Other|||||||0.4801|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.|||
1737624|NCT00468845|3198503|Superiority or Other|||||||0.4944|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.|||
1737625|NCT00468845|3198503|Superiority or Other|||||||0.9676|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.|||
1737626|NCT00468845|3198504|Superiority or Other|||||||0.7699|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS|
1737627|NCT00468845|3198504|Superiority or Other|||||||0.5879|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS|
1737628|NCT00468845|3198504|Superiority or Other|||||||0.4852|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS|
1737629|NCT00468845|3198504|Superiority or Other|||||||0.5446|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS|
1737630|NCT00468845|3198504|Superiority or Other|||||||0.6906|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS|
1737631|NCT00468845|3198504|Superiority or Other|||||||0.0183|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS|
1737632|NCT00468845|3198504|Superiority or Other|||||||0.2752|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS|
1737633|NCT00468845|3198504|Superiority or Other|||||||0.2033|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS|
1737634|NCT00468845|3198504|Superiority or Other|||||||0.9747|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS|
1737635|NCT00468845|3198504|Superiority or Other|||||||0.3704|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS|
1737636|NCT00468845|3198504|Superiority or Other|||||||0.8582|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS|
1737637|NCT00468845|3198504|Superiority or Other|||||||0.5997|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS|
1737638|NCT00468845|3198505|Superiority or Other|||||||0.3854|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28|
1737639|NCT00468845|3198505|Superiority or Other|||||||0.7257|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 28|
1737640|NCT00468845|3198505|Superiority or Other|||||||0.7022|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14|
1737641|NCT00468845|3198505|Superiority or Other|||||||0.2468|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Day 14|
1737642|NCT00468845|3198505|Superiority or Other|||||||0.0164|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737643|NCT00468845|3198505|Superiority or Other|||||||0.2932|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||Discharge|
1737644|NCT00468845|3198505|Superiority or Other|||||||0.7396|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS|
1737645|NCT00468845|3198505|Superiority or Other|||||||0.9333|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||144 hours PS|
1737646|NCT00468845|3198505|Superiority or Other|||||||0.55|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS|
1737647|NCT00468845|3198505|Superiority or Other|||||||0.4678|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||120 hours PS|
1737648|NCT00468845|3198505|Superiority or Other|||||||0.9907|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS|
1737649|NCT00468845|3198505|Superiority or Other|||||||0.0942|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||96 hours PS|
1737650|NCT00468845|3198505|Superiority or Other|||||||0.6255|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS|
1737651|NCT00468845|3198505|Superiority or Other|||||||0.2117|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||72 hours PS|
1737652|NCT00468845|3198505|Superiority or Other|||||||0.8618|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS|
1737653|NCT00468845|3198505|Superiority or Other|||||||0.7029|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||48 hours PS|
1737654|NCT00468845|3198505|Superiority or Other|||||||0.3375|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS|
1743514|NCT00413283|3206866|Superiority or Other|||||||0.101|||||||Satterthwaite t-test||||
1737655|NCT00468845|3198505|Superiority or Other|||||||0.7752|||||||ANOVA|LS Means from ANOVA model with terms of treatment, pooled center and salpingo-oophorectomy strata.||24 hours PS|
1737656|NCT00468845|3198506|Superiority or Other|||||||0.471||||||Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg.|ANOVA||||
1737657|NCT00468845|3198506|Superiority or Other|||||||0.1378||||||Weighted Z-score test method of Fisher (1998) and Cui et al (1999)applied to maintain alpha level. A step down procedure for multiple comparisons to control the maximum experiment wise type I error rate at 0.05 level. 300mg tested prior to 150mg.|ANOVA||||
1737658|NCT00468728|3198525|Superiority or Other||Risk Difference (RD)|13.4||||0.001||95.0|5.4|21.1|||Chi-squared||||
1737659|NCT00468728|3198526|Superiority or Other||Risk Difference (RD)|-14.4|||<|0.001|2-Sided|95.0|-21.6|-7.0|||Chi-squared||||
1737660|NCT00468728|3198527|Non-Inferiority or Equivalence|The point estimate of the difference and the 2-sided 95% confidence interval (CI) for the difference between treatment groups were computed. If the lower limit of the CI was greater than -10%, the clinical non-inferiority of fidaxomicin was demonstrated. CIs for the difference of cure rates were calculated using the method recommended by Agresti and Caffo.|Risk Difference (RD)|1.0|||||2-Sided|95.0|-4.8|6.8||||||H0: C(OPT-80) – C(VAN) <= -10% Power calculation is based on cure rate of 85% in both treatment groups, non-inferiority margin of 10%, 2.5% (1-sided) type I error rate with approximately 90% power gives a total of 530 subjects.|
1737661|NCT00468676|3198528|Superiority or Other||Estimated Between Group Difference|-0.56|||||2-Sided|95.0|-0.85|-0.27|||||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.||
1737662|NCT00468676|3198529|Superiority or Other||Estimated Between Group Difference|-9.1|||||2-Sided|95.0|-17.5|-0.8|||||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a linear-regression model predicting a 12-month outcome.||
1737663|NCT00468676|3198530|Superiority or Other||Estimated Between Group Difference|-3.4|||||2-Sided|95.0|-6.9|0.1|||||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.||
1737664|NCT00468676|3198531|Superiority or Other||Estimated Between Group Difference|-0.41|||<|0.001|2-Sided|95.0|-0.56|-0.26|||Generalized-Estimating-Equation Model||Between Group Difference is the difference in the change from Baseline to 12 month data calculated from a generalized-estimating-equation model predicting a 6- and 12-month outcome.||
1737665|NCT00468676|3198533|Superiority or Other||Slope|0.01|||<|0.01||95.0|||||general estimating equations|||Disability outcomes were measured at six and 12 months after randomization using linear regression models adjusted for baseline values. The disability models combined information across time points and were estimated using general estimating equations to account for correlation. All analyses were based on intent to treat principles|
1737666|NCT00468676|3198534|Superiority or Other||scaled marginal model parameter|-1.57|Standard Error of the Mean|0.28||0.001|2-Sided|95.0|-2.12|-1.02||Significance of the four outcome composite|Scaled Marginal Model||Intervention group had significantly lower scaled marginal mean scores than usual care||
1737667|NCT00468650|3198535|Superiority or Other||Mean Difference (Net)|10.33|Standard Deviation|31.36|<|0.001||95.0|4.41|16.26||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737668|NCT00468650|3198535|Superiority or Other||Mean Difference (Net)|10.15|Standard Deviation|31.11|<|0.001||95.0|4.32|15.97||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737669|NCT00468650|3198535|Superiority or Other||Mean Difference (Net)|8.75|Standard Deviation|29.26|<|0.0025||95.0|3.15|14.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737670|NCT00468650|3198535|Superiority or Other||Mean Difference (Net)|9.18|Standard Deviation|29.45|<|0.0014||95.0|3.61|14.74||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737671|NCT00468650|3198536|Superiority or Other||Mean Difference (Net)|34.26|Standard Deviation|43.29|<|0.001||95.0|25.72|42.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline|
1737672|NCT00468650|3198536|Superiority or Other||Mean Difference (Net)|34.57|Standard Deviation|43.48|<|0.001||95.0|26.07|43.07||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline|
1737673|NCT00468650|3198536|Superiority or Other||Mean Difference (Net)|35.31|Standard Deviation|43.52|<|0.001||95.0|26.59|44.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline|
1737674|NCT00468650|3198536|Superiority or Other||Mean Difference (Net)|32.3|Standard Deviation|42.15|<|0.001||95.0|23.97|40.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline|
1737675|NCT00468650|3198536|Superiority or Other||Mean Difference (Net)|22.45|Standard Deviation|46.1|<|0.001||95.0|13.44|31.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline|
1737676|NCT00468650|3198537|Superiority or Other||Mean Difference (Net)|30.98|Standard Deviation|42.06|<|0.001||95.0|23.04|38.93||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737677|NCT00468650|3198537|Superiority or Other||Mean Difference (Net)|30.43|Standard Deviation|41.88|<|0.001||95.0|22.59|38.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737678|NCT00468650|3198537|Superiority or Other||Mean Difference (Net)|30.92|Standard Deviation|41.9|<|0.001||95.0|22.89|38.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737679|NCT00468650|3198537|Superiority or Other||Mean Difference (Net)|27.53|Standard Deviation|40.19|<|0.001||95.0|19.94|35.13||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737680|NCT00468650|3198538|Superiority or Other||Mean Difference (Net)|65.13|Standard Deviation|45.56|<|0.001||95.0|56.14|74.12||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline|
1737681|NCT00468650|3198538|Superiority or Other||Mean Difference (Net)|64.84|Standard Deviation|45.7|<|0.001||95.0|55.91|73.77||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline|
1737682|NCT00468650|3198538|Superiority or Other||Mean Difference (Net)|66.1|Standard Deviation|45.15|<|0.001||95.0|57.05|75.16||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline|
1737683|NCT00468650|3198538|Superiority or Other||Mean Difference (Net)|61.45|Standard Deviation|44.77|<|0.001||95.0|52.61|70.29||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline|
1737684|NCT00468650|3198538|Superiority or Other||Mean Difference (Net)|33.27|Standard Deviation|41.43|<|0.001||95.0|25.17|41.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline|
1737685|NCT00468650|3198539|Superiority or Other||Mean Difference (Net)|-20.65|Standard Deviation|46.2|<|0.001||95.0|-29.38|-11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737686|NCT00468650|3198539|Superiority or Other||Mean Difference (Net)|-20.28|Standard Deviation|45.86|<|0.001||95.0|-28.87|-11.69||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737687|NCT00468650|3198539|Superiority or Other||Mean Difference (Net)|-22.16|Standard Deviation|45.24|<|0.001||95.0|-30.84|-13.49||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737688|NCT00468650|3198539|Superiority or Other||Median Difference (Net)|-18.36|Standard Deviation|46.03|<|0.001||95.0|-27.05|-9.66||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737689|NCT00468650|3198540|Superiority or Other||Mean Difference (Net)|-30.87|Standard Deviation|60.54|<|0.001||95.0|-42.82|-18.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline|
1737690|NCT00468650|3198540|Superiority or Other||Mean Difference (Net)|-30.27|Standard Deviation|61.7|<|0.001||95.0|-42.33|-18.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline|
1737691|NCT00468650|3198540|Superiority or Other||Mean Difference (Net)|-30.79|Standard Deviation|60.9|<|0.001||95.0|-43.0|-18.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline|
1737692|NCT00468650|3198540|Superiority or Other||Mean Difference (Net)|-29.16|Standard Deviation|59.81|<|0.001||95.0|-40.96|-17.35||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline|
1737693|NCT00468650|3198540|Superiority or Other||Mean Difference (Net)|-10.82|Standard Deviation|56.75|<|0.0558||95.0|-21.91|0.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline|
1737694|NCT00468650|3198541|Superiority or Other||Mean Difference (Net)|-2.76|Standard Deviation|22.48||0.2||95.0|-7.01|1.48||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737695|NCT00468650|3198541|Superiority or Other||Mean Difference (Net)|-2.71|Standard Deviation|22.28||0.2||95.0|-6.89|1.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737696|NCT00468650|3198541|Superiority or Other||Mean Difference (Net)|-1.91|Standard Deviation|20.73||0.3435||95.0|-5.88|2.07||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737697|NCT00468650|3198541|Superiority or Other||Mean Difference (Net)|-2.39|Standard Deviation|22.0||0.2567||95.0|-6.55|1.77||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737698|NCT00468650|3198542|Superiority or Other||Mean Difference (Net)|-12.4|Standard Deviation|33.13|<|0.001||95.0|-18.94|-5.86||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline|
1737699|NCT00468650|3198542|Superiority or Other||Mean Difference (Net)|-13.13|Standard Deviation|33.94|<|0.001||95.0|-19.76|-6.5||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline|
1737700|NCT00468650|3198542|Superiority or Other||Mean Difference (Net)|-12.78|Standard Deviation|33.56|<|0.001||95.0|-19.51|-6.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline|
1737701|NCT00468650|3198542|Superiority or Other||Mean Difference (Net)|-11.74|Standard Deviation|32.8|<|0.001||95.0|-18.22|-5.27||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline|
1737702|NCT00468650|3198542|Superiority or Other||Mean Difference (Net)|-9.87|Standard Deviation|34.44|<|0.0045||95.0|-16.6|-3.14||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline|
1737703|NCT00468650|3198543|Superiority or Other||Mean Difference (Net)|-7.57|Standard Deviation|24.4||0.0015||95.0|-12.18|-2.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1743515|NCT00413283|3206866|Superiority or Other|||||||0.454|||||||Satterthwaite t-test||||
1737704|NCT00468650|3198543|Superiority or Other||Mean Difference (Net)|-7.43|Standard Deviation|24.2||0.0015||95.0|-11.97|-2.9||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737705|NCT00468650|3198543|Superiority or Other||Mean Difference (Net)|-6.85|Standard Deviation|23.02||0.0027||95.0|-11.26|-2.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737706|NCT00468650|3198543|Superiority or Other||Mean Difference (Net)|-6.79|Standard Deviation|22.58||0.0021||95.0|-11.06|-2.52||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737707|NCT00468650|3198544|Superiority or Other||Mean Difference (Net)|-21.86|Standard Deviation|36.29|<|0.001||95.0|-29.03|-14.7||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline|
1737708|NCT00468650|3198544|Superiority or Other||Mean Difference (Net)|-21.44|Standard Deviation|36.06|<|0.001||95.0|-28.49|-14.39||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline|
1737709|NCT00468650|3198544|Superiority or Other||Mean Difference (Net)|-22.53|Standard Deviation|36.64|<|0.001||95.0|-29.88|-15.18||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline|
1737710|NCT00468650|3198544|Superiority or Other||Mean Difference (Net)|-20.55|Standard Deviation|35.04|<|0.001||95.0|-27.47|-13.64||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline|
1737711|NCT00468650|3198544|Superiority or Other||Mean Difference (Net)|-12.58|Standard Deviation|37.77|<|0.001||95.0|-19.96|-5.2||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline|
1737712|NCT00468650|3198545|Superiority or Other||Mean Difference (Net)|14.77|Standard Deviation|32.0|<|0.001||95.0|8.72|20.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737713|NCT00468650|3198545|Superiority or Other||Mean Difference (Net)|14.51|Standard Deviation|31.77|<|0.001||95.0|8.56|20.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737714|NCT00468650|3198545|Superiority or Other||Mean Difference (Net)|14.25|Standard Deviation|31.31|<|0.001||95.0|8.25|20.25||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737715|NCT00468650|3198545|Superiority or Other||Mean Difference (Net)|13.56|Standard Deviation|30.89|<|0.001||95.0|7.72|19.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737716|NCT00468650|3198546|Superiority or Other||Mean Difference (Net)|71.6|Standard Deviation|35.55|<|0.001||95.0|64.54|78.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline|
1737717|NCT00468650|3198546|Superiority or Other||Mean Difference (Net)|72.15|Standard Deviation|35.41|<|0.001||95.0|65.2|79.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline|
1737718|NCT00468650|3198546|Superiority or Other||Mean Difference (Net)|71.23|Standard Deviation|35.79|<|0.001||95.0|64.02|78.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline|
1737719|NCT00468650|3198546|Superiority or Other||Mean Difference (Net)|70.78|Standard Deviation|35.46|<|0.001||95.0|63.74|77.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline|
1737720|NCT00468650|3198546|Superiority or Other||Mean Difference (Net)|56.96|Standard Deviation|38.93|<|0.001||95.0|49.31|64.6||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline|
1737721|NCT00468650|3198547|Superiority or Other||Mean Difference (Net)|13.72|Standard Deviation|32.16|<|0.001||95.0|7.61|19.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737722|NCT00468650|3198547|Superiority or Other||Mean Difference (Net)|13.47|Standard Deviation|31.92|<|0.001||95.0|7.47|19.47||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737723|NCT00468650|3198547|Superiority or Other||Mean Difference (Net)|14.11|Standard Deviation|32.53|<|0.001||95.0|7.84|20.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737724|NCT00468650|3198547|Superiority or Other||Mean Difference (Net)|13.1|Standard Deviation|29.11|<|0.001||95.0|7.58|18.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737725|NCT00468650|3198548|Superiority or Other||Mean Difference (Net)|71.51|Standard Deviation|40.48|<|0.001||95.0|63.48|79.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline|
1737726|NCT00468650|3198548|Superiority or Other||Mean Difference (Net)|72.07|Standard Deviation|40.27|<|0.001||95.0|64.16|79.98||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline|
1737727|NCT00468650|3198548|Superiority or Other||Mean Difference (Net)|70.63|Standard Deviation|40.78|<|0.001||95.0|62.41|78.85||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline|
1737728|NCT00468650|3198548|Superiority or Other||Mean Difference (Net)|70.72|Standard Deviation|40.3|<|0.001||95.0|62.72|78.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline|
1743516|NCT00413283|3206867|Superiority or Other|||||||0.342|||||||Fisher Exact||||
1737729|NCT00468650|3198548|Superiority or Other||Mean Difference (Net)|57.34|Standard Deviation|42.6|<|0.001||95.0|48.93|65.75||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline|
1737730|NCT00468650|3198549|Superiority or Other||Mean Difference (Net)|19.88|Standard Deviation|37.23|<|0.001||95.0|12.84|26.91||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737731|NCT00468650|3198549|Superiority or Other||Mean Difference (Net)|19.52|Standard Deviation|36.99|<|0.001||95.0|12.59|26.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737732|NCT00468650|3198549|Superiority or Other||Mean Difference (Net)|19.5|Standard Deviation|36.84|<|0.001||95.0|12.44|26.56||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737733|NCT00468650|3198549|Superiority or Other||Mean Difference (Net)|17.9|Standard Deviation|36.63|<|0.001||95.0|10.98|24.83||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737734|NCT00468650|3198550|Superiority or Other||Mean Difference (Net)|78.36|Standard Deviation|36.89|<|0.001||95.0|71.04|85.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline|
1737735|NCT00468650|3198550|Superiority or Other||Mean Difference (Net)|78.79|Standard Deviation|36.65|<|0.001||95.0|71.59|85.99||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline|
1737736|NCT00468650|3198550|Superiority or Other||Mean Difference (Net)|77.69|Standard Deviation|37.26|<|0.001||95.0|70.18|85.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline|
1737737|NCT00468650|3198550|Superiority or Other||Mean Difference (Net)|76.29|Standard Deviation|37.21|<|0.001||95.0|68.9|83.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline|
1737738|NCT00468650|3198550|Superiority or Other||Mean Difference (Net)|58.58|Standard Deviation|41.24|<|0.001||95.0|50.48|66.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline|
1737739|NCT00468650|3198551|Superiority or Other||Mean Difference (Net)|14.77|Standard Deviation|32.0|<|0.001||95.0|8.72|20.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737740|NCT00468650|3198551|Superiority or Other||Mean Difference (Net)|14.51|Standard Deviation|31.77|<|0.001||95.0|8.56|20.46||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737741|NCT00468650|3198551|Superiority or Other||Mean Difference (Net)|14.25|Standard Deviation|31.31|<|0.001||95.0|8.25|20.25||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737742|NCT00468650|3198551|Superiority or Other||Mean Difference (Net)|13.56|Standard Deviation|30.89|<|0.001||95.0|7.72|19.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737743|NCT00468650|3198552|Superiority or Other||Mean Difference (Net)|71.6|Standard Deviation|35.55|<|0.001||95.0|64.54|78.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline|
1737744|NCT00468650|3198552|Superiority or Other||Mean Difference (Net)|72.15|Standard Deviation|35.41|<|0.001||95.0|65.2|79.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline|
1737745|NCT00468650|3198552|Superiority or Other||Mean Difference (Net)|71.23|Standard Deviation|35.79|<|0.001||95.0|64.02|78.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline|
1737746|NCT00468650|3198552|Superiority or Other||Mean Difference (Net)|70.78|Standard Deviation|35.46|<|0.001||95.0|63.74|77.81||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline|
1737747|NCT00468650|3198552|Superiority or Other||Mean Difference (Net)|56.96|Standard Deviation|38.93|<|0.001||95.0|49.31|64.6||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline|
1737748|NCT00468650|3198553|Superiority or Other||Mean Difference (Net)|1.15|Standard Deviation|12.16||0.3236||95.0|-1.15|3.45||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737749|NCT00468650|3198553|Superiority or Other||Mean Difference (Net)|1.13|Standard Deviation|12.05||0.3236||95.0|-1.13|3.38||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737750|NCT00468650|3198553|Superiority or Other||Mean Difference (Net)|1.18|Standard Deviation|12.33||0.3237||95.0|-1.18|3.54||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737751|NCT00468650|3198553|Superiority or Other||Mean Difference (Net)|1.46|Standard Deviation|9.41||0.1061||95.0|-0.32|3.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737752|NCT00468650|3198554|Superiority or Other||Mean Difference (Net)|17.68|Standard Deviation|32.1|<|0.001||95.0|11.31|24.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline|
1737753|NCT00468650|3198554|Superiority or Other||Mean Difference (Net)|17.33|Standard Deviation|31.87|<|0.001||95.0|11.07|23.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline|
1743517|NCT00413283|3206867|Superiority or Other|||||||1|||||||Fisher Exact||||
1737754|NCT00468650|3198554|Superiority or Other||Mean Difference (Net)|18.22|Standard Deviation|32.44|<|0.001||95.0|11.68|24.76||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline|
1737755|NCT00468650|3198554|Superiority or Other||Mean Difference (Net)|17.15|Standard Deviation|32.22|<|0.001||95.0|10.76|23.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline|
1737756|NCT00468650|3198554|Superiority or Other||Mean Difference (Net)|15.37|Standard Deviation|30.51|<|0.001||95.0|9.38|21.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline|
1737757|NCT00468650|3198555|Superiority or Other||Mean Difference (Net)|3.04|Standard Deviation|14.07||0.0249||95.0|0.39|5.68||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737758|NCT00468650|3198555|Superiority or Other||Mean Difference (Net)|2.98|Standard Deviation|13.95||0.0249||95.0|0.37|5.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737759|NCT00468650|3198555|Superiority or Other||Mean Difference (Net)|3.12|Standard Deviation|14.26||0.0249||95.0|0.4|5.84||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737760|NCT00468650|3198555|Superiority or Other||Mean Difference (Net)|1.37|Standard Deviation|14.85||0.3324||95.0|-1.42|4.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737761|NCT00468650|3198556|Superiority or Other||Mean Difference (Net)|11.95|Standard Deviation|28.55|<|0.001||95.0|6.51|17.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus baseline|
1737762|NCT00468650|3198556|Superiority or Other||Mean Difference (Net)|11.96|Standard Deviation|28.33|<|0.001||95.0|6.61|17.32||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus baseline|
1737763|NCT00468650|3198556|Superiority or Other||Mean Difference (Net)|12.29|Standard Deviation|28.88|<|0.001||95.0|6.7|17.88||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline|
1737764|NCT00468650|3198556|Superiority or Other||Mean Difference (Net)|10.18|Standard Deviation|27.51|<|0.001||95.0|4.93|15.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline|
1737765|NCT00468650|3198556|Superiority or Other||Median Difference (Net)|8.84|Standard Deviation|28.7|<|0.0016||95.0|3.42|14.26||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline|
1737766|NCT00468650|3198557|Superiority or Other||Mean Difference (Net)|1.98|Standard Deviation|2.07|<|0.001||95.0|1.59|2.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737767|NCT00468650|3198557|Superiority or Other||Mean Difference (Net)|1.98|Standard Deviation|2.07|<|0.001||95.0|1.59|2.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737768|NCT00468650|3198557|Superiority or Other||Mean Difference (Net)|1.96|Standard Deviation|2.08|<|0.001||95.0|1.57|2.36||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737769|NCT00468650|3198557|Superiority or Other||Mean Difference (Net)|1.49|Standard Deviation|1.91|<|0.001||95.0|1.13|1.85||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737770|NCT00468650|3198558|Superiority or Other||Mean Difference (Net)|4.76|Standard Deviation|2.82|<|0.001||95.0|4.23|5.3||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline|
1737771|NCT00468650|3198558|Superiority or Other||Mean Difference (Net)|4.78|Standard Deviation|2.81|<|0.001||95.0|4.25|5.31||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline|
1737772|NCT00468650|3198558|Superiority or Other||Mean Difference (Net)|4.74|Standard Deviation|2.84|<|0.001||95.0|4.2|5.28||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline|
1737773|NCT00468650|3198558|Superiority or Other||Mean Difference (Net)|4.23|Standard Deviation|2.56|<|0.001||95.0|3.74|4.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline|
1737774|NCT00468650|3198558|Superiority or Other||Mean Difference (Net)|2.79|Standard Deviation|2.44|<|0.001||95.0|2.33|3.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline|
1737775|NCT00468650|3198559|Superiority or Other||Mean Difference (Net)|4.01|Standard Deviation|5.04|<|0.001||95.0|3.06|4.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737776|NCT00468650|3198559|Superiority or Other||Mean Difference (Net)|4.01|Standard Deviation|5.04|<|0.001||95.0|3.06|4.96||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737777|NCT00468650|3198559|Superiority or Other||Mean Difference (Net)|4.03|Standard Deviation|5.09|<|0.001||95.0|3.06|5.0||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737778|NCT00468650|3198559|Superiority or Other||Mean Difference (Net)|3.29|Standard Deviation|4.1|<|0.001||95.0|2.52|4.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1738028|NCT00464945|3199210|Superiority or Other||Ratio|0.93||||||95.0|0.71|1.22||||||For serotype 14 the GMC ratio was calculated|
1737779|NCT00468650|3198560|Superiority or Other||Mean Difference (Net)|10.64|Standard Deviation|5.06|<|0.001||95.0|9.68|11.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline|
1737780|NCT00468650|3198560|Superiority or Other||Mean Difference (Net)|10.63|Standard Deviation|5.03|<|0.001||95.0|9.68|11.58||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline|
1737781|NCT00468650|3198560|Superiority or Other||Mean Difference (Net)|10.59|Standard Deviation|5.08|<|0.001||95.0|9.62|11.56||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline|
1737782|NCT00468650|3198560|Superiority or Other||Mean Difference (Net)|9.94|Standard Deviation|5.21|<|0.001||95.0|8.96|10.91||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline|
1737783|NCT00468650|3198560|Superiority or Other||Mean Difference (Net)|6.68|Standard Deviation|4.86|<|0.001||95.0|5.77|7.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline|
1737784|NCT00468650|3198561|Superiority or Other||Mean Difference (Net)|3.91|Standard Deviation|4.38|<|0.001||95.0|3.09|4.73||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737785|NCT00468650|3198561|Superiority or Other||Mean Difference (Net)|3.91|Standard Deviation|4.38|<|0.001||95.0|3.09|4.73||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737786|NCT00468650|3198561|Superiority or Other||Mean Difference (Net)|3.91|Standard Deviation|4.41|<|0.001||95.0|3.08|4.74||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737787|NCT00468650|3198561|Superiority or Other||Mean Difference (Net)|3.51|Standard Deviation|3.89|<|0.001||95.0|2.78|4.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737788|NCT00468650|3198562|Superiority or Other||Mean Difference (Net)|9.25|Standard Deviation|5.15|<|0.001||95.0|8.28|10.22||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline|
1737789|NCT00468650|3198562|Superiority or Other||Mean Difference (Net)|9.28|Standard Deviation|5.14|<|0.001||95.0|8.32|10.24||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline|
1737790|NCT00468650|3198562|Superiority or Other||Mean Difference (Net)|9.21|Standard Deviation|5.19|<|0.001||95.0|8.23|10.19||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline|
1737791|NCT00468650|3198562|Superiority or Other||Mean Difference (Net)|8.85|Standard Deviation|4.96|<|0.001||95.0|7.92|9.78||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline|
1737792|NCT00468650|3198562|Superiority or Other||Mean Difference (Net)|5.41|Standard Deviation|4.4|<|0.001||95.0|4.59|6.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline|
1737793|NCT00468650|3198563|Superiority or Other||Mean Difference (Net)|12.69|Standard Deviation|24.26|<|0.001||95.0|8.14|17.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737794|NCT00468650|3198563|Superiority or Other||Mean Difference (Net)|12.69|Standard Deviation|24.26|<|0.001||95.0|8.14|17.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737795|NCT00468650|3198563|Superiority or Other||Mean Difference (Net)|13.07|Standard Deviation|24.25|<|0.001||95.0|8.49|17.65||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737796|NCT00468650|3198563|Superiority or Other||Mean Difference (Net)|13.84|Standard Deviation|21.1|<|0.001||95.0|9.89|17.79||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737797|NCT00468650|3198564|Superiority or Other||Mean Difference (Net)|45.05|Standard Deviation|27.02|<|0.001||95.0|39.99|50.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline|
1737798|NCT00468650|3198564|Superiority or Other||Mean Difference (Net)|45.28|Standard Deviation|27.01|<|0.001||95.0|40.25|50.31||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline|
1737799|NCT00468650|3198564|Superiority or Other||Mean Difference (Net)|45.53|Standard Deviation|26.96|<|0.001||95.0|40.44|50.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline|
1737800|NCT00468650|3198564|Superiority or Other||Mean Difference (Net)|46.21|Standard Deviation|26.27|<|0.001||95.0|41.29|51.12||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline|
1737801|NCT00468650|3198564|Superiority or Other||Mean Difference (Net)|32.71|Standard Deviation|25.36|<|0.001||95.0|27.98|37.43||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline|
1737802|NCT00468650|3198565|Superiority or Other||Mean Difference (Net)|1.2|Standard Deviation|1.9|<|0.001||95.0|0.84|1.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737803|NCT00468650|3198565|Superiority or Other||Mean Difference (Net)|1.2|Standard Deviation|1.9|<|0.001||95.0|0.84|1.55||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1738029|NCT00464945|3199210|Superiority or Other||Ratio|1.05||||||95.0|0.89|1.24||||||For serotype 9V the GMC ratio was calculated|
1737804|NCT00468650|3198565|Superiority or Other||Mean Difference (Net)|1.21|Standard Deviation|1.92|<|0.001||95.0|0.85|1.57||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737805|NCT00468650|3198565|Superiority or Other||Mean Difference (Net)|0.97|Standard Deviation|1.88|<|0.001||95.0|0.62|1.32||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737806|NCT00468650|3198566|Superiority or Other||Mean Difference (Net)|3.89|Standard Deviation|2.53|<|0.001||95.0|3.42|4.37||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline|
1737807|NCT00468650|3198566|Superiority or Other||Mean Difference (Net)|3.91|Standard Deviation|2.53|<|0.001||95.0|3.44|4.38||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline|
1737808|NCT00468650|3198566|Superiority or Other||Mean Difference (Net)|3.92|Standard Deviation|2.52|<|0.001||95.0|3.44|4.4||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline|
1737809|NCT00468650|3198566|Superiority or Other||Mean Difference (Net)|3.67|Standard Deviation|2.49|<|0.001||95.0|3.2|4.14||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline|
1737810|NCT00468650|3198566|Superiority or Other||Mean Difference (Net)|2.73|Standard Deviation|2.38|<|0.001||95.0|2.28|3.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline|
1737811|NCT00468650|3198567|Superiority or Other||Mean Difference (Net)|1.54|Standard Deviation|2.19|<|0.001||95.0|1.13|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737812|NCT00468650|3198567|Superiority or Other||Mean Difference (Net)|1.54|Standard Deviation|2.19|<|0.001||95.0|1.13|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737813|NCT00468650|3198567|Superiority or Other||Mean Difference (Net)|1.54|Standard Deviation|2.2|<|0.001||95.0|1.12|1.95||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737814|NCT00468650|3198567|Superiority or Other||Mean Difference (Net)|1.2|Standard Deviation|2.1|<|0.001||95.0|0.8|1.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737815|NCT00468650|3198568|Superiority or Other||Mean Difference (Net)|4.72|Standard Deviation|2.52|<|0.001||95.0|4.25|5.19||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline|
1737816|NCT00468650|3198568|Superiority or Other||Mean Difference (Net)|4.7|Standard Deviation|2.52|<|0.001||95.0|4.23|5.17||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline|
1737817|NCT00468650|3198568|Superiority or Other||Mean Difference (Net)|4.73|Standard Deviation|2.53|<|0.001||95.0|4.25|5.21||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline|
1737818|NCT00468650|3198568|Superiority or Other||Mean Difference (Net)|4.38|Standard Deviation|2.39|<|0.001||95.0|3.94|4.83||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline|
1737819|NCT00468650|3198568|Superiority or Other||Mean Difference (Net)|3.18|Standard Deviation|2.42|<|0.001||95.0|2.73|3.63||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline|
1737820|NCT00468650|3198569|Superiority or Other||Mean Difference (Net)|0.83|Standard Deviation|1.49|<|0.001||95.0|0.55|1.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737821|NCT00468650|3198569|Superiority or Other||Mean Difference (Net)|0.83|Standard Deviation|1.49|<|0.001||95.0|0.55|1.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737822|NCT00468650|3198569|Superiority or Other||Mean Difference (Net)|0.81|Standard Deviation|1.47|<|0.001||95.0|0.53|1.09||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737823|NCT00468650|3198569|Superiority or Other||Mean Difference (Net)|0.55|Standard Deviation|1.41|<|0.001||95.0|0.29|0.82||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737824|NCT00468650|3198570|Superiority or Other||Mean Difference (Net)|2.28|Standard Deviation|1.93|<|0.001||95.0|1.91|2.64||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline|
1737825|NCT00468650|3198570|Superiority or Other||Mean Difference (Net)|2.26|Standard Deviation|1.94|<|0.001||95.0|1.9|2.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline|
1737826|NCT00468650|3198570|Superiority or Other||Mean Difference (Net)|2.25|Standard Deviation|1.91|<|0.001||95.0|1.89|2.62||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline|
1737827|NCT00468650|3198570|Superiority or Other||Mean Difference (Net)|2.0|Standard Deviation|1.86|<|0.001||95.0|1.65|2.35||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline|
1737828|NCT00468650|3198570|Superiority or Other||Mean Difference (Net)|1.43|Standard Deviation|1.87|<|0.001||95.0|1.09|1.78||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline|
1738030|NCT00464945|3199210|Superiority or Other||Ratio|0.96||||||95.0|0.7|1.31||||||For serotype 6B the GMC ratio was calculated|
1737829|NCT00468650|3198571|Superiority or Other||Mean Difference (Net)|0.74|Standard Deviation|1.45|<|0.001||95.0|0.47|1.01||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2|
1737830|NCT00468650|3198571|Superiority or Other||Mean Difference (Net)|0.74|Standard Deviation|1.45|<|0.001||95.0|0.47|1.01||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2|
1737831|NCT00468650|3198571|Superiority or Other||Mean Difference (Net)|0.75|Standard Deviation|1.46|<|0.001||95.0|0.47|1.02||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2|
1737832|NCT00468650|3198571|Superiority or Other||Mean Difference (Net)|0.61|Standard Deviation|1.51|<|0.001||95.0|0.32|0.89||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737833|NCT00468650|3198572|Superiority or Other||Mean Difference (Net)|2.59|Standard Deviation|2.42|<|0.001||95.0|2.14|3.04||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Baseline|
1737834|NCT00468650|3198572|Superiority or Other||Mean Difference (Net)|2.63|Standard Deviation|2.45|<|0.001||95.0|2.17|3.08||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Baseline|
1737835|NCT00468650|3198572|Superiority or Other||Mean Difference (Net)|2.59|Standard Deviation|2.44|<|0.001||95.0|2.13|3.05||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Baseline|
1737836|NCT00468650|3198572|Superiority or Other||Mean Difference (Net)|2.46|Standard Deviation|2.32|<|0.001||95.0|2.02|2.89||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Baseline|
1737837|NCT00468650|3198572|Superiority or Other||Mean Difference (Net)|1.89|Standard Deviation|2.4|<|0.001||95.0|1.45|2.34||p-value not adjusted for multiple comparisons. Threshold for significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus Baseline|
1737838|NCT00468650|3198573|Superiority or Other||Mean Difference (Net)|3.86|Standard Deviation|4.35|<|0.001||95.0|3.04|4.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 Endpoint minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05|
1737839|NCT00468650|3198573|Superiority or Other||Mean Difference (Net)|3.86|Standard Deviation|4.35|<|0.001||95.0|3.04|4.67||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 LOCF minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05|
1737840|NCT00468650|3198573|Superiority or Other||Mean Difference (Net)|3.88|Standard Deviation|4.38|<|0.001||95.0|3.05|4.71||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus Week 2 For the secondary outcome, the change in IIEF-EF domain from the end of 50 mg period (Week 2) to the end of 100 mg period (Week 6), the sample size (N=115) provides more than 80% power to detect a mean change of 1.75 points, assuming a standard deviation of 6, using the two-sided, single sample t-test with significance level (alpha) of 0.05|
1737841|NCT00468650|3198573|Superiority or Other||Mean Difference (Net)|3.48|Standard Deviation|3.97|<|0.001||95.0|2.74|4.23||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus Week 2|
1737842|NCT00468650|3198574|Superiority or Other||Mean Difference (Net)|10.95|Standard Deviation|5.21|<|0.001||95.0|9.97|11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 endpoint minus baseline|
1737843|NCT00468650|3198574|Superiority or Other||Mean Difference (Net)|10.93|Standard Deviation|5.26|<|0.001||95.0|9.93|11.92||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 6 minus baseline|
1737844|NCT00468650|3198574|Superiority or Other||Mean Difference (Net)|10.57|Standard Deviation|5.43|<|0.001||95.0|9.56|11.59||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 4 minus baseline|
1737845|NCT00468650|3198574|Superiority or Other||Mean Difference (Net)|7.14|Standard Deviation|5.21|<|0.001||95.0|6.17|8.11||p-value not adjusted for multiple comparisons. Threshold for statistical significance p<0.05|t-test, 2 sided|single sample t-test||Week 2 minus baseline|
1737846|NCT00468650|3198575|Superiority or Other||Mean Difference (Net)|10.96|Standard Deviation|5.19|<|0.001||95.0|10.0|11.93||"Statistical significance will be declared if the p-value is <0.05.~Change from Baseline: Week 6 (LOCF) minus Baseline"|t-test, 2 sided|single sample t-test||Primary hypothesis to be tested is whether there is a significant improvement in the IIEF EF domain at the end of the 100 mg period, as compared to the baseline (Week 0) score. Sample size (N=115) provides more than 90% power to detect a change from baseline of 10 in the primary efficacy variable, assuming a standard deviation of 9, using the two-sided, single-sample t-test with significance level (alpha) of 0.05.|
1737847|NCT00468481|3198647|Superiority or Other||Mean Difference (Final Values)|18.87|||<|0.0001||95.0|14.04|23.7|||ANCOVA|Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (plasma folate) as covariate|Difference =DRSP/EE/MTHF - YAZ|The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the plasma folate levels at week 24 was 0.|
1737848|NCT00468481|3198648|Superiority or Other||Mean Difference (Final Values)|384.7|||<|0.0001||95.0|282.42|486.98|||ANCOVA|Analysis of Covariance (ANCOVA) with treatment as factor and Baseline (RBC folate) as covariate|Difference = DRSP/EE/MTHF - YAZ|The null hypothesis was that the difference between DRSP/EE/MTHF and Yaz treatment groups in the RBC folate levels at week 24 was 0.|
1737849|NCT00468312|3198649|Superiority or Other|||||||0.269|||||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.|||
1737850|NCT00468312|3198650|Superiority or Other||||||<|0.001|||||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.|||
1737851|NCT00468312|3198651|Superiority or Other||||||<|0.001|||||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.|||
1737852|NCT00468312|3198652|Superiority or Other|||||||0.026|||||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.|||
1737853|NCT00468312|3198653|Superiority or Other||||||<|0.001|||||||ANCOVA|Analysis of covariance (ANCOVA) extracted sources of variation due to treatment, variable specific baseline, and site.|||
1737854|NCT00468169|3198675|Superiority or Other (legacy)|||||||0.1225||||||Log-rank test comparing PFS between two treatment arms|Log Rank||||
1737855|NCT00468104|3198685|Superiority or Other||||||<|0.001|||||||Chi-squared|||A univariate analysis was done to identify possible predictors of successful resolution of symptoms. The chi-square analysis was used to compare the percent successful.|
1737856|NCT00468052|3198688|Superiority or Other|||||||0.02|||||||Fisher Exact||||
1737857|NCT00468052|3198689|Superiority or Other|||||||0.03|||||||Fisher Exact||||
1737858|NCT00468052|3198691|Superiority or Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)||||
1737859|NCT00468052|3198692|Non-Inferiority or Equivalence|Treatment with Dex would reduce the incidence of severe agitation be 50% with an 80% power (alpha 0.05)||||||0.001|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis dexmedetomidine would be a safe and effective substitute to opiates in reducing pain and the incidence of severe EA|
1737860|NCT00468052|3198692|Superiority or Other|||||||0.001||||||Null hypothesis is not significantly different from group D and F.|Wilcoxon (Mann-Whitney)|||Sixty subjects were required per group to determine that with Dex would decrease the incidence of severe EA after surgery by 50% with 80% power (0.05)in comparison with the control group.60 subjects were required by group to show the that intraoperative rescue fentanyl and rescue morphine in the PACU would be 50% lower in subjects receiving dex.|
1737861|NCT00467896|3198694|Superiority or Other||Mean Difference (Net)|49.8|||<|0.0001|2-Sided|95.0|39.55|60.15|||t-test, 2 sided|||Comparison of the change in inhalation-times rate from Period I (PD-6) to Period II (PD-15)|
1737862|NCT00467857|3198746|Superiority or Other|||||||0.024|||||||Fisher Exact||||
1737863|NCT00467857|3198747|Superiority or Other|||||||0.285|||||||Chi-squared||||
1737864|NCT00467857|3198748|Superiority or Other|||||||0.512|||||||Wilcoxon-Rank Sum Test||||
1737865|NCT00467857|3198749|Superiority or Other|||||||0.348|||||||Wilcoxon-Rank Sum Test||||
1737866|NCT00467857|3198750|Superiority or Other|||||||0.73|||||||Wilcoxon-Rank Sum Test||||
1737867|NCT00467857|3198751|Superiority or Other|||||||0.359|||||||Wilcoxon-Rank Sum Test|||The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.|
1737868|NCT00467857|3198752|Superiority or Other|||||||0.96|||||||Wilcoxon-Rank Sum Test||||
1737869|NCT00467857|3198753|Superiority or Other|||||||0.788|||||||Wilcoxon-Rank Sum Test||||
1737870|NCT00467857|3198754|Superiority or Other|||||||0.646|||||||Wilcoxon-Rank Sum Test||||
1737871|NCT00467857|3198755|Superiority or Other|||||||0.057|||||||Wilcoxon-Rank Sum Test||||
1737872|NCT00467857|3198756|Superiority or Other|||||||0.039|||||||Wilcoxon-Rank Sum Test||||
1737873|NCT00467857|3198757|Superiority or Other|||||||0.375|||||||Wilcoxon-Rank Sum Test||||
1737874|NCT00467857|3198758|Superiority or Other|||||||0.276|||||||Wilcoxon-Rank Sum Test||||
1737875|NCT00467857|3198759|Superiority or Other|||||||0.655|||||||Wilcoxon-Rank Sum Test|||The sample size determination was selected to achieve 80% power to detect an absolute 10% difference between the two treatment groups in proportion of qualitative reduction in representative skin flora, at a significance level (alpha) of 0.05 using a two-sided z-test with continuity correction.|
1737876|NCT00467740|3198813|Superiority or Other||Mean Difference (Final Values)|-0.276|Standard Error of the Mean|0.113||0.0158||95.0|-0.499|-0.052|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1737877|NCT00467740|3198813|Superiority or Other||Mean Difference (Final Values)|-0.328|Standard Error of the Mean|0.114||0.0044||95.0|-0.552|-0.103|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1737878|NCT00467740|3198813|Superiority or Other||Mean Difference (Final Values)|-0.197|Standard Error of the Mean|0.114||0.0869||95.0|-0.422|0.029|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1737879|NCT00467740|3198813|Superiority or Other||Mean Difference (Final Values)|-0.142|Standard Error of the Mean|0.114||0.2156||95.0|-0.368|0.083|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1737880|NCT00467740|3198822|Superiority or Other||Mean Difference (Final Values)|-0.593|Standard Error of the Mean|0.257||0.0218|2-Sided|95.0|-1.098|-0.087|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1737881|NCT00467740|3198822|Superiority or Other||Mean Difference (Final Values)|-0.332|Standard Error of the Mean|0.259||0.2008|2-Sided|95.0|-0.842|0.178|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1737882|NCT00467740|3198822|Superiority or Other||Mean Difference (Final Values)|-0.526|Standard Error of the Mean|0.258||0.0423|2-Sided|95.0|-1.034|-0.018|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1737883|NCT00467740|3198822|Superiority or Other||Mean Difference (Final Values)|-0.287|Standard Error of the Mean|0.257||0.2645|2-Sided|95.0|-0.793|0.218|||ANCOVA|Analysis of covariance model with terms for baseline, treatment, centre (centre random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1737884|NCT00467740|3198823|Superiority or Other||Mean Difference (Final Values)|-2.937|Standard Error of the Mean|1.053||0.0056|2-Sided|95.0|-5.01|-0.865|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737885|NCT00467740|3198823|Superiority or Other||Mean Difference (Final Values)|-3.045|Standard Error of the Mean|1.063||0.0045|2-Sided|95.0|-5.138|-0.952|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737886|NCT00467740|3198823|Superiority or Other||Mean Difference (Final Values)|-2.351|Standard Error of the Mean|1.057||0.027|2-Sided|95.0|-4.432|-0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737887|NCT00467740|3198823|Superiority or Other||Mean Difference (Final Values)|-1.118|Standard Error of the Mean|1.055||0.2898|2-Sided|95.0|-3.194|0.957|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737888|NCT00467740|3198824|Superiority or Other||Mean Difference (Final Values)|42.505|Standard Error of the Mean|7.675|<|0.0001|2-Sided|95.0|27.399|57.611|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737889|NCT00467740|3198824|Superiority or Other||Mean Difference (Final Values)|36.806|Standard Error of the Mean|7.727|<|0.0001|2-Sided|95.0|21.598|52.015|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737890|NCT00467740|3198824|Superiority or Other||Mean Difference (Final Values)|24.6|Standard Error of the Mean|7.7|<|0.0016|2-Sided|95.0|9.446|39.754|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737891|NCT00467740|3198824|Superiority or Other||Mean Difference (Final Values)|22.97|Standard Error of the Mean|7.665|<|0.003|2-Sided|95.0|7.883|38.057|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737892|NCT00467740|3198825|Superiority or Other||Mean Difference (Final Values)|0.162|Standard Error of the Mean|0.068||0.0177|2-Sided|95.0|0.028|0.296|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737893|NCT00467740|3198825|Superiority or Other||Mean Difference (Final Values)|0.038|Standard Error of the Mean|0.068||0.5714|2-Sided|95.0|-0.095|0.171|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737894|NCT00467740|3198825|Superiority or Other||Mean Difference (Final Values)|0.044|Standard Error of the Mean|0.068||0.515|2-Sided|95.0|-0.089|0.178|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737895|NCT00467740|3198825|Superiority or Other||Mean Difference (Final Values)|0.052|Standard Error of the Mean|0.067||0.4331|2-Sided|95.0|-0.079|0.184|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737896|NCT00467740|3198826|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.069||0.0006||95.0|0.104|0.375|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737897|NCT00467740|3198826|Superiority or Other||Mean Difference (Final Values)|0.036|Standard Error of the Mean|0.069||0.602||95.0|-0.1|0.171|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737898|NCT00467740|3198826|Superiority or Other||Mean Difference (Final Values)|0.068|Standard Error of the Mean|0.069||0.3284||95.0|-0.068|0.204|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737899|NCT00467740|3198826|Superiority or Other||Mean Difference (Final Values)|0.075|Standard Error of the Mean|0.069||0.2781||95.0|-0.061|0.21|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737900|NCT00467740|3198827|Superiority or Other||Mean Difference (Final Values)|0.176|Standard Error of the Mean|0.064||0.0064||95.0|0.05|0.303|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737901|NCT00467740|3198827|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.064||0.4378||95.0|-0.077|0.177|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737902|NCT00467740|3198827|Superiority or Other||Mean Difference (Final Values)|0.106|Standard Error of the Mean|0.065||0.1031||95.0|-0.021|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737903|NCT00467740|3198827|Superiority or Other||Mean Difference (Final Values)|0.143|Standard Error of the Mean|0.064||0.027||95.0|0.016|0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737904|NCT00467740|3198828|Superiority or Other||Mean Difference (Final Values)|0.185|Standard Error of the Mean|0.059||0.002||95.0|0.068|0.302|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1738031|NCT00464945|3199210|Superiority or Other||Ratio|1.35||||||95.0|1.1|1.65||||||For serotype 4 the GMC ratio was calculated|
1738247|NCT00461591|3199785|Superiority||Odds Ratio (OR)|0.76||||0.1068|2-Sided|95.0|0.54|1.06|||Cochran-Mantel-Haenszel||||
1737905|NCT00467740|3198828|Superiority or Other||Mean Difference (Final Values)|0.077|Standard Error of the Mean|0.06||0.196||95.0|-0.04|0.195|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737906|NCT00467740|3198828|Superiority or Other||Mean Difference (Final Values)|0.119|Standard Error of the Mean|0.06||0.047||95.0|0.002|0.237|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737907|NCT00467740|3198828|Superiority or Other||Mean Difference (Final Values)|0.099|Standard Error of the Mean|0.059||0.0959||95.0|-0.018|0.216|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737908|NCT00467740|3198829|Superiority or Other||Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.056||0.0014||95.0|0.07|0.289|||Mixed Models Analysis||Olo 20 mcg qd minus Placebo||
1737909|NCT00467740|3198829|Superiority or Other||Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.056||0.0838||95.0|-0.013|0.207|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737910|NCT00467740|3198829|Superiority or Other||Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.056||0.0848||95.0|-0.013|0.207|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737911|NCT00467740|3198829|Superiority or Other||Mean Difference (Final Values)|0.079|Standard Error of the Mean|0.056||0.1585||95.0|-0.031|0.188|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737912|NCT00467740|3198830|Superiority or Other||Mean Difference (Final Values)|0.232|Standard Error of the Mean|0.054|<|0.0001||95.0|0.127|0.337|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737913|NCT00467740|3198830|Superiority or Other||Mean Difference (Final Values)|0.081|Standard Error of the Mean|0.054|<|0.132||95.0|-0.025|0.187|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737914|NCT00467740|3198830|Superiority or Other||Mean Difference (Final Values)|0.117|Standard Error of the Mean|0.054|<|0.0307||95.0|0.011|0.223|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737915|NCT00467740|3198830|Superiority or Other||Mean Difference (Final Values)|0.166|Standard Error of the Mean|0.054|<|0.0022||95.0|0.06|0.271|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737916|NCT00467740|3198831|Superiority or Other||Mean Difference (Final Values)|0.221|Standard Error of the Mean|0.055|<|0.0001||95.0|0.114|0.328|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737917|NCT00467740|3198831|Superiority or Other||Mean Difference (Final Values)|0.079|Standard Error of the Mean|0.055|<|0.1513||95.0|-0.029|0.186|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737918|NCT00467740|3198831|Superiority or Other||Mean Difference (Final Values)|0.153|Standard Error of the Mean|0.055|<|0.0057||95.0|0.045|0.261|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737919|NCT00467740|3198831|Superiority or Other||Mean Difference (Final Values)|0.204|Standard Error of the Mean|0.055|<|0.0002||95.0|0.096|0.312|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737920|NCT00467740|3198832|Superiority or Other||Mean Difference (Final Values)|0.237|Standard Error of the Mean|0.048|<|0.0001||95.0|0.142|0.332|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737921|NCT00467740|3198832|Superiority or Other||Mean Difference (Final Values)|0.138|Standard Error of the Mean|0.048|<|0.0047||95.0|0.043|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737922|NCT00467740|3198832|Superiority or Other||Mean Difference (Final Values)|0.185|Standard Error of the Mean|0.048|<|0.0002||95.0|0.09|0.281|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737923|NCT00467740|3198832|Superiority or Other||Mean Difference (Final Values)|0.173|Standard Error of the Mean|0.048|<|0.0004||95.0|0.078|0.268|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737924|NCT00467740|3198833|Superiority or Other||Mean Difference (Final Values)|0.296|Standard Error of the Mean|0.048|<|0.0001||95.0|0.202|0.39|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737925|NCT00467740|3198833|Superiority or Other||Mean Difference (Final Values)|0.173|Standard Error of the Mean|0.048|<|0.0004||95.0|0.078|0.268|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737926|NCT00467740|3198833|Superiority or Other||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.048|<|0.0003||95.0|0.08|0.269|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737927|NCT00467740|3198833|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.048|<|0.0005||95.0|0.074|0.263|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737928|NCT00467740|3198834|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.049|<|0.0001||95.0|0.143|0.336|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737929|NCT00467740|3198834|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.049|<|0.0427||95.0|0.003|0.197|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737930|NCT00467740|3198834|Superiority or Other||Mean Difference (Final Values)|0.132|Standard Error of the Mean|0.049|<|0.0077||95.0|0.035|0.229|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737931|NCT00467740|3198834|Superiority or Other||Median Difference (Final Values)|0.179|Standard Error of the Mean|0.049|<|0.0003||95.0|0.082|0.276|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737932|NCT00467740|3198835|Superiority or Other||Mean Difference (Final Values)|0.227|Standard Error of the Mean|0.05|<|0.0001||95.0|0.129|0.326|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737933|NCT00467740|3198835|Superiority or Other||Mean Difference (Final Values)|0.088|Standard Error of the Mean|0.05|<|0.0795||95.0|-0.01|0.187|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737934|NCT00467740|3198835|Superiority or Other||Mean Difference (Final Values)|0.156|Standard Error of the Mean|0.05|<|0.0021||95.0|0.057|0.255|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737935|NCT00467740|3198835|Superiority or Other||Mean Difference (Final Values)|0.214|Standard Error of the Mean|0.05|<|0.0001||95.0|0.115|0.313|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737936|NCT00467740|3198836|Superiority or Other||Mean Difference (Final Values)|0.263|Standard Error of the Mean|0.045|<|0.0001||95.0|0.174|0.352|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737937|NCT00467740|3198836|Superiority or Other||Mean Difference (Final Values)|0.157|Standard Error of the Mean|0.045|<|0.0007||95.0|0.067|0.246|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737938|NCT00467740|3198836|Superiority or Other||Mean Difference (Final Values)|0.196|Standard Error of the Mean|0.046|<|0.0001||95.0|0.107|0.286|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737939|NCT00467740|3198836|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.045|<|0.0001||95.0|0.101|0.279|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737940|NCT00467740|3198837|Superiority or Other||Mean Difference (Final Values)|0.291|Standard Error of the Mean|0.039|<|0.0001||95.0|0.214|0.367|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737941|NCT00467740|3198837|Superiority or Other||Mean Difference (Final Values)|0.173|Standard Error of the Mean|0.039|<|0.0001||95.0|0.096|0.25|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737942|NCT00467740|3198837|Superiority or Other||Mean Difference (Final Values)|0.183|Standard Error of the Mean|0.039|<|0.0001||95.0|0.106|0.26|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737943|NCT00467740|3198837|Superiority or Other||Mean Difference (Final Values)|0.178|Standard Error of the Mean|0.039|<|0.0001||95.0|0.102|0.255|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737944|NCT00467740|3198838|Superiority or Other||Mean Difference (Final Values)|0.191|Standard Error of the Mean|0.062||0.0022||95.0|0.069|0.312|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737945|NCT00467740|3198838|Superiority or Other||Mean Difference (Final Values)|0.037|Standard Error of the Mean|0.062||0.5504||95.0|-0.085|0.158|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737946|NCT00467740|3198838|Superiority or Other||Mean Difference (Final Values)|0.077|Standard Error of the Mean|0.062||0.2118||95.0|-0.044|0.199|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737947|NCT00467740|3198838|Superiority or Other||Mean Difference (Final Values)|0.082|Standard Error of the Mean|0.061||0.1811||95.0|-0.039|0.203|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737948|NCT00467740|3198839|Superiority or Other||Mean Difference (Final Values)|0.232|Standard Error of the Mean|0.05|<|0.0001||95.0|0.133|0.331|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737949|NCT00467740|3198839|Superiority or Other||Mean Difference (Final Values)|0.099|Standard Error of the Mean|0.05|<|0.0512||95.0|-0.001|0.198|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1738032|NCT00464945|3199214|Superiority or Other||Difference|0.0||||||95.0|-3.6|3.5||||||For serotype 19A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated|
1737950|NCT00467740|3198839|Superiority or Other||Mean Difference (Final Values)|0.137|Standard Error of the Mean|0.051|<|0.007||95.0|0.038|0.237|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737951|NCT00467740|3198839|Superiority or Other||Mean Difference (Final Values)|0.178|Standard Error of the Mean|0.05|<|0.0005||95.0|0.079|0.277|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737952|NCT00467740|3198840|Superiority or Other||Mean Difference (Final Values)|0.147|Standard Error of the Mean|0.053||0.006||95.0|0.042|0.252|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737953|NCT00467740|3198840|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.054||0.6516||95.0|-0.081|0.13|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737954|NCT00467740|3198840|Superiority or Other||Mean Difference (Final Values)|0.058|Standard Error of the Mean|0.054||0.2832||95.0|-0.048|0.164|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737955|NCT00467740|3198840|Superiority or Other||Mean Difference (Final Values)|0.037|Standard Error of the Mean|0.053||0.4902||95.0|-0.068|0.142|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737956|NCT00467740|3198841|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.053||0.0147||95.0|0.026|0.233|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737957|NCT00467740|3198841|Superiority or Other||Mean Difference (Final Values)|0.028|Standard Error of the Mean|0.053||0.602||95.0|-0.077|0.132|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737958|NCT00467740|3198841|Superiority or Other||Mean Difference (Final Values)|0.099|Standard Error of the Mean|0.053||0.0646||95.0|-0.006|0.204|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737959|NCT00467740|3198841|Superiority or Other||Mean Difference (Final Values)|0.127|Standard Error of the Mean|0.053||0.017||95.0|0.023|0.232|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737960|NCT00467740|3198842|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.046||0.0051||95.0|0.039|0.221|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737961|NCT00467740|3198842|Superiority or Other||Mean Difference (Final Values)|0.069|Standard Error of the Mean|0.046||0.1369||95.0|-0.022|0.16|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737962|NCT00467740|3198842|Superiority or Other||Median Difference (Final Values)|0.043|Standard Error of the Mean|0.046||0.3527||95.0|-0.048|0.135|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737963|NCT00467740|3198842|Superiority or Other||Mean Difference (Final Values)|0.051|Standard Error of the Mean|0.046||0.2646||95.0|-0.039|0.142|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737964|NCT00467740|3198843|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.048||0.0037||95.0|0.046|0.234|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737965|NCT00467740|3198843|Superiority or Other||Mean Difference (Final Values)|0.043|Standard Error of the Mean|0.048||0.3738||95.0|-0.052|0.137|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737966|NCT00467740|3198843|Superiority or Other||Mean Difference (Final Values)|0.089|Standard Error of the Mean|0.048||0.0666||95.0|-0.006|0.184|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737967|NCT00467740|3198843|Superiority or Other||Mean Difference (Final Values)|0.103|Standard Error of the Mean|0.048||0.0329||95.0|0.008|0.198|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737968|NCT00467740|3198844|Superiority or Other||Mean Difference (Final Values)|0.173|Standard Error of the Mean|0.044||0.0001||95.0|0.087|0.26|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737969|NCT00467740|3198844|Superiority or Other||Mean Difference (Final Values)|0.114|Standard Error of the Mean|0.044||0.0106||95.0|0.027|0.2|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737970|NCT00467740|3198844|Superiority or Other||Mean Difference (Final Values)|0.101|Standard Error of the Mean|0.044||0.0232||95.0|0.014|0.188|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737971|NCT00467740|3198844|Superiority or Other||Mean Difference (Final Values)|0.067|Standard Error of the Mean|0.044||0.1264||95.0|-0.019|0.154|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1738103|NCT00463385|3199453|Superiority or Other (legacy)|||||||0.048|||||||Fisher Exact||||
1737972|NCT00467740|3198845|Superiority or Other||Mean Difference (Final Values)|42.943|Standard Error of the Mean|7.848|<|0.0001||95.0|27.498|58.389|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737973|NCT00467740|3198845|Superiority or Other||Mean Difference (Final Values)|36.072|Standard Error of the Mean|7.906|<|0.0001||95.0|20.512|51.633|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737974|NCT00467740|3198845|Superiority or Other||Mean Difference (Final Values)|27.878|Standard Error of the Mean|7.875|<|0.0005||95.0|12.379|43.378|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737975|NCT00467740|3198845|Superiority or Other||Mean Difference (Final Values)|16.238|Standard Error of the Mean|7.843|<|0.0393||95.0|0.801|31.675|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737976|NCT00467740|3198846|Superiority or Other||Mean Difference (Final Values)|0.147|Standard Error of the Mean|0.044||0.0011||95.0|0.059|0.234|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 20 mcg qd minus Placebo||
1737977|NCT00467740|3198846|Superiority or Other||Mean Difference (Final Values)|0.076|Standard Error of the Mean|0.045||0.0906||95.0|-0.012|0.164|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 10 mcg qd minus Placebo||
1737978|NCT00467740|3198846|Superiority or Other||Median Difference (Final Values)|0.086|Standard Error of the Mean|0.045||0.0571||95.0|-0.003|0.174|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 5 mcg qd minus Placebo||
1737979|NCT00467740|3198846|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.045||0.0754||95.0|-0.008|0.167|||Mixed Models Analysis|Mixed effect model with terms baseline, treatment, test day, baseline-by-test-day, treatment-by-test-day, and center as random effect|Olo 2 mcg qd minus Placebo||
1737980|NCT00467649|3198858|Superiority or Other|||||||0.018|||||||Fisher Exact||||
1737981|NCT00467363|3198876|Superiority or Other||Risk Difference (RD)|0.3||||0.77|2-Sided|95.0|-0.8|1.4|||Fisher Exact||||
1737982|NCT00467363|3198879|Superiority or Other||Risk Ratio (RR)|0.72||||0.2603|2-Sided|95.0|0.42|1.23|||Fisher Exact||||
1737983|NCT00467363|3198880|Superiority or Other|||||||0.7802|||||||t-test, 2 sided||||
1737984|NCT00467363|3198881|Superiority or Other||Risk Ratio (RR)|1.08||||0.7943|2-Sided|95.0|0.67|1.76|||Fisher Exact||||
1737985|NCT00467363|3198882|Superiority or Other||Risk Ratio (RR)|1.03||||1|2-Sided|95.0|0.21|5.06|||Fisher Exact||||
1737986|NCT00467363|3198883|Superiority or Other||Risk Ratio (RR)|1.03||||1|2-Sided|95.0|0.21|5.06|||Fisher Exact||||
1737987|NCT00467363|3198884|Superiority or Other||Risk Ratio (RR)|1.03||||1|2-Sided|95.0|0.15|7.26|||Fisher Exact||||
1737988|NCT00467363|3198885|Superiority or Other||Risk Ratio (RR)|0.68||||0.753|2-Sided|95.0|0.19|2.41|||Fisher Exact||||
1737989|NCT00467363|3198886|Superiority or Other||Risk Ratio (RR)|1.08||||0.6869|2-Sided|95.0|0.76|1.55|||Fisher Exact||||
1737990|NCT00467363|3198887|Superiority or Other||Risk Ratio (RR)|1.06||||0.8902|2-Sided|95.0|0.64|1.78|||Fisher Exact||||
1737991|NCT00467363|3198888|Superiority or Other||Risk Ratio (RR)|1.1||||0.0329|2-Sided|95.0|1.01|1.19|||Fisher Exact||||
1737992|NCT00467363|3198889|Superiority or Other||Risk Ratio (RR)|1.1||||0.0165|2-Sided|95.0|1.02|1.19|||Fisher Exact||||
1737993|NCT00467363|3198890|Superiority or Other||Risk Ratio (RR)|1.1||||0.0984|2-Sided|95.0|0.98|1.22||Only one outcome for primary outcome, so no adjustment of p-value for multiple comparisons was done. A priori threshold for statistical significance was p<0.05.|Fisher Exact|No adjustments were done. Treatment groups were similar with respect to the assessed demographic and baseline characteristics||The study was designed to detect a 10% absolute difference in livebirth rate with 80% power and a type I error rate of 5%, on the assumption that participants taking placebo who achieved pregnancy would have a livebirth rate of 75%.|
1737994|NCT00467285|3198899|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||comparison of changes in BMD at 6months compared to baseline|
1737995|NCT00467259|3198900|Superiority or Other|||||||1|||||||Fisher Exact|p-value obtained from Fisher's Exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.|
1737996|NCT00467259|3198901|Superiority or Other|||||||1|||||||Fisher Exact|p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.|
1737997|NCT00467259|3198902|Superiority or Other|||||||1|||||||Fisher Exact|p-value obtained from Fisher's exact test and corresponds to the test of the null hypothesis of no treatment difference.||1000 naturally postmenopausal women not on concomitant E+P therapy at baseline were to be randomized (800 TTS; 200 placebo). It was assumed 60% would complete 1 year and 80% of these would have evaluable biopsies. Of the 800 randomized to TTS approximately 380 were expected to have evaluable biopsies at 1 year. 380 patients on TTS with evaluable biopsies at 1 year would provide 90% power to rule out an incidence of hyperplasia of 2% using the upper bound of a 2-sided 95% CI.|
1737998|NCT00467038|3198909|Superiority or Other|||||||0.08|||||||Fisher's LSD post-hoc, trend level||||
1738000|NCT00466310|3199035|Superiority or Other|||||||0.0149||||||Unadjusted p value is .0041|Wilcoxon (Mann-Whitney)|||A wilcoxon rank sum test was performed comparing baseline plasmalogen values, comparing schizophrenia subjects vs controls.P values from this analysis were adjusted for false discovery rates by the method of Storey and Tribshiani.|
1738001|NCT00466193|3199041|Superiority or Other|||||||0.0041||||||P-value is for treatment|ANCOVA||||
1738002|NCT00466193|3199044|Superiority or Other|||||||0.006||||||p-value is for treatment|ANCOVA||||
1738003|NCT00466193|3199046|Superiority or Other||||||<|0.001||||||p-value is for treatment|ANCOVA||||
1738004|NCT00466167|3199066|Superiority or Other||Adjusted mean difference from placebo|7.1|Standard Error of the Mean|1.7|<|0.0001|2-Sided|95.0|3.7|10.5|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline|
1738005|NCT00466167|3199066|Superiority or Other||Adjusted mean difference from Placebo|4.5|Standard Error of the Mean|1.8|<|0.0122|2-Sided|95.0|1.0|7.9|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline|
1738006|NCT00466167|3199067|Superiority or Other||Adjusted mean difference from placebo|6.6|Standard Error of the Mean|1.2|<|0.0001|2-Sided|95.0|4.2|9.1|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline|
1738007|NCT00466167|3199067|Superiority or Other||Adjusted mean difference from placebo|4.9|Standard Error of the Mean|1.3|<|0.0001|2-Sided|95.0|2.4|7.4|||ANCOVA|||ANCOVA with factors treatment, pooled country and covariate baseline|
1738008|NCT00465894|3199093|Superiority|||||||0.45|||||||t-test, 2 sided||||
1738009|NCT00465816|3199116|Non-Inferiority|The lower limit of the two-sided standardised asymptotic 95% CI for group difference (Nimenrix+Twinrix group minus Twinrix group) in the percentage of subjects with vaccine seroconversion was ≥ pre-defined clinical limit of -10%.|Percentage difference|-0.91|||||2-Sided|95.0|-2.64|2.92||||||To assess the Non-inferiority of the Nimenrix+Twinrix group compared to the Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroprotection rates for hepatitis B (Nimenrix+Twinrix group minus Twinrix group) was computed.|
1738010|NCT00465816|3199117|Non-Inferiority|The lower limit of the two-sided standardised asymptotic 95% CI for group difference (Nimenrix+Twinrix group minus Twinrix group) in the percentage of subjects with vaccine seroconversion was ≥ pre-defined clinical limit of -10%.|Percentage difference|0.0|||||2-Sided|95.0|-1.19|3.9||||||To assess the Non-inferiority of the Nimenrix+Twinrix group compared to Twinrix one, two-sided standardized asymptotic 95% CI for the difference in seroconversion rates for hepatitis A (Nimenrix+Twinrix group minus Twinrix group) was computed.|
1738011|NCT00465816|3199118|Non-Inferiority|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenY GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|1.01|||||2-Sided|95.0|0.85|1.19||||||To assess the Non-inferiority in term of rSBA-MenY GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.|
1738012|NCT00465816|3199118|Non-Inferiority|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenW-135 GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|1.02|||||2-Sided|95.0|0.87|1.19||||||To assess the Non-inferiority in term of rSBA-MenW-135 GMT of the Nimenrix+Twinrixg roup compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.|
1738013|NCT00465816|3199118|Non-Inferiority|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenC GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|0.91|||||2-Sided|95.0|0.68|1.21||||||To assess the Non-inferiority in term of rSBA-MenC GMT of the Nimenrix+Twinrix group compared to Nimenrix one, Two-sided 95% CI from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.|
1738014|NCT00465816|3199118|Non-Inferiority|The lower limit of the two-sided 95% CI on the ratio of rSBA-MenA GMTs between Nimenrix + Twinrix group and (over) Nimenrix group was ≥ 0.5.|Adjusted GMT ratio|0.99|||||2-Sided|95.0|0.8|1.22||||||To assess the Non-inferiority in term of rSBA-MenA GMT of the Nimenrix + Twinrix group compared to Nimenrix one, two-sided 95% confidence interval (CI) from ANCOVA model on the GMTs ratio (Nimenrix+Twinrix group over Nimenrix group) was computed. The model was adjusted for age strata and baseline titre.|
1738015|NCT00465738|3199161|Non-Inferiority or Equivalence|A two-sided 95% Newcombe-Wilson confidence interval for the difference between the response rates of the groups was calculated. The lower bound of the Newcombe-Wilson CI for the difference of proportions was compared to the non-inferiority margin of –25%.|difference in response rates|10.6|||||2-Sided|95.0|-4.4|24.9|||||difference in response rates = response rate for high volume dilution group (20 U/ml) - response rate for low volume dilution group (50 U/ml)|Null hypothesis: The response rate for the low volume dilution group (50 U/ml) is greater than the response rate for the high volume dilution group (20 U/ml).|
1738016|NCT00465270|3199175|Other||Cox Proportional Hazard|0.55||||0.046|2-Sided|95.0|0.31|0.999|||Log Rank||||
1738017|NCT00465270|3199177|Other||Cox Proportional Hazard|0.49||||0.08|2-Sided|95.0|0.22|1.11|||Log Rank||||
1738018|NCT00465088|3199209|Superiority or Other||||||<|0.001||||||alpha = 0.05|Mixed Models Analysis|||An n = 81 for niacin extended-release with simvastatin and n = 54 for atorvastatin would provide > 99% power to detect a 13% increase in HDL-C with niacin extended-release with simvastatin relative to atorvastatin, assuming an SD of 16%|
1738019|NCT00464945|3199210|Superiority or Other||Ratio|0.95||||||95.0|0.79|1.13||||||For serotype 19A the GMC ratio was calculated|
1738020|NCT00464945|3199210|Superiority or Other||Ratio|0.93||||||95.0|0.79|1.11||||||For serotype 7F the GMC ratio was calculated|
1738021|NCT00464945|3199210|Superiority or Other||Ratio|0.83||||||95.0|0.66|1.05||||||For serotype 6A the GMC ratio was calculated|
1738022|NCT00464945|3199210|Superiority or Other||Ratio|0.95||||||95.0|0.79|1.16||||||For serotype 5 the GMC ratio was calculated|
1738023|NCT00464945|3199210|Superiority or Other||Ratio|1.0||||||95.0|0.83|1.2||||||For serotype 3 the GMC ratio was calculated|
1738024|NCT00464945|3199210|Superiority or Other||Ratio|1.1||||||95.0|0.88|1.37||||||For serotype 1 the GMC ratio was calculated|
1738025|NCT00464945|3199210|Superiority or Other||Ratio|0.9||||||95.0|0.7|1.15||||||For serotype 23F the GMC ratio was calculated|
1738033|NCT00464945|3199214|Superiority or Other||Difference|0.0||||||95.0|-3.0|2.8||||||For serotype 7F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated|
1738034|NCT00464945|3199214|Superiority or Other||Difference|-1.1||||||95.0|-9.9|7.6||||||For serotype 6A the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated|
1738035|NCT00464945|3199214|Superiority or Other||Difference|2.1||||||95.0|-5.6|9.9||||||For serotype 5 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated|
1738036|NCT00464945|3199214|Superiority or Other||Difference|-1.7||||||95.0|-7.9|4.2||||||For serotype 3 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated|
1738037|NCT00464945|3199214|Superiority or Other||Difference|2.1||||||95.0|-4.8|9.2||||||For serotype 1 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated|
1738038|NCT00464945|3199214|Superiority or Other||Difference|1.1||||||95.0|-8.4|10.6||||||For serotype 23F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated|
1738039|NCT00464945|3199214|Superiority or Other||Difference|0.7||||||95.0|-3.5|5.1||||||For serotype 19F the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated|
1738040|NCT00464945|3199214|Superiority or Other||Difference|3.0||||||95.0|-2.8|9.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated|
1738041|NCT00464945|3199214|Superiority or Other||Difference|-1.6||||||95.0|-8.2|4.7||||||For serotype 14 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated|
1738042|NCT00464945|3199214|Superiority or Other||Difference|2.3||||||95.0|-2.1|7.3||||||For serotype 9V the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated|
1738043|NCT00464945|3199214|Superiority or Other||Difference|3.3||||||95.0|-7.3|13.8||||||For serotype 6B the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated|
1738044|NCT00464945|3199214|Superiority or Other||Difference|0.7||||||95.0|-3.9|5.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC Manufacturing - 13vPnC Pilot) was calculated|
1738045|NCT00464815|3199226|Non-Inferiority|Criterion for non-inferiority: the upper limit (UL) of the 2-sided standardized asymptotic 95% CI for the ratio of the percentages of subjects with any Grade 3 general symptom was lower than or equal to (≤) the pre-defined clinical limit of 3.0.|Risk Ratio (RR)|4.02||||0.1456|2-Sided|95.0|0.68|24.6|||Chi-squared|||To demonstrate the non-inferiority of Nimenrix™ vaccine versus Mencevax™ vaccine in terms of incidence of any Grade 3 general (solicited and unsolicited) symptom, the 2-sided standardised asymptotic 95% CI for the ratio between Nimenrix and Mencevax groups (Nimenrix over Mencevax) in the percentage of subjects with any grade 3 general symptom within 4 days after vaccination was computed for the safety analysis in study MenACWY-TT-036.|
1738046|NCT00464815|3199227|Non-Inferiority|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference [Nimenrix Group minus Mencevax ACWY Group] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|15.22|||||2-Sided|95.0|9.89|21.37||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenY vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup Y (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.|
1738047|NCT00464815|3199227|Non-Inferiority|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval for the group difference [Nimenrix Group minus Mencevax ACWY Group] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|8.9|||||2-Sided|95.0|4.78|14.14||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenW-135 vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup W-135 (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.|
1738048|NCT00464815|3199227|Non-Inferiority|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval for the group difference [Nimenrix Group minus Mencevax ACWY Group] in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate Difference|0.67|||||2-Sided|95.0|-1.65|4.18||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenC vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup C (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.|
1738049|NCT00464815|3199227|Non-Inferiority|Criterion for non-inferiority: the lower limit (LL) of the 2-sided standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix Group minus Mencevax ACWY Group) in the percentage of subjects with bactericidal vaccine response was greater than or equal to (≥) the pre-defined clinical limit of -10%.|Rate difference|7.87|||||2-Sided|95.0|1.63|14.87||||||To demonstrate the non-inferiority of Nimenrix vaccine versus Mencevax ACWY vaccine in term of rSBA-MenA vaccine response, the standardized asymptotic 95% CI for the difference in rSBA vaccine response rate for the meningococcal serogroup A (Nimenrix Group rate minus Mencevax ACWY Group rate) one month after vaccination was computed.|
1738050|NCT00464568|3199286|Superiority or Other||Mean treatment difference|-1.5165|Standard Deviation|12.70748||0.84479|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 200 mcg: pVASP|
1738051|NCT00464568|3199286|Superiority or Other||Mean treatment difference|0.156|Standard Deviation|4.73976||0.89831|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 50 mcg: pVASP|
1738052|NCT00464568|3199286|Superiority or Other||Mean treatment difference|-1.6602|Standard Deviation|12.30724||0.65729|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 10 mcg: pVASP|
1738104|NCT00463385|3199453|Superiority or Other (legacy)|||||||0.092|||||||Fisher Exact||||
1738053|NCT00464568|3199286|Superiority or Other||Mean treatment difference|-2.8053|Standard Deviation|10.88217||0.32998|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo Vs GSK256066 1 mcg: pVASP|
1738054|NCT00464568|3199286|Superiority or Other||Mean treatment difference|-1.3371|Standard Deviation|7.5459||0.81527|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 200 mcg: VASP|
1738055|NCT00464568|3199286|Superiority or Other||Mean treatment difference|0.0256|Standard Deviation|9.24118||0.53499|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo Vs GSK256066 50 mcg: VASP|
1738056|NCT00464568|3199286|Superiority or Other||Mean treatment difference|-0.3816|Standard Deviation|9.00754||0.95084|||||||Mixed effects analysis of variance model||The mean treatment difference was calculated as treatment minus placebo|Placebo vs GSK256066 10 mcg: VASP|
1738057|NCT00464568|3199286|Superiority or Other||Mean treatment difference|-0.5545|Standard Deviation|7.79598||0.647226|||||||Mixed effects analysis of variance model|||Placebo vs GSK256066 1 mcg: VASP|
1738058|NCT00464568|3199301|Superiority or Other||Treatment Ratios|3.32|Standard Error of the Mean|0.055|<|0.0001|2-Sided|95.0|2.59|4.27|||ANOVA|||RGS1; Placebo vs GSK256066 200 mcg|
1738059|NCT00464568|3199301|Superiority or Other||Treatment Ratios|3.28|Standard Error of the Mean|0.056|<|0.0001|2-Sided|95.0|2.54|4.23|||ANOVA|||RGS1; Placebo vs GSK256066 50 mcg|
1738060|NCT00464568|3199301|Superiority or Other||Treatment Ratios|3.04|Standard Error of the Mean|0.055|<|0.0001|2-Sided|95.0|2.37|3.9|||ANOVA|||SNF1LK; Placebo vs GSK256066 10 mcg|
1738061|NCT00464568|3199301|Superiority or Other||Treatment Ratios|2.72|Standard Error of the Mean|0.056|<|0.0001|2-Sided|95.0|2.11|3.51|||ANOVA|||SNF1LK; Placebo vs GSK256066 1 mcg|
1738062|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.37|Standard Error of the Mean|0.08|<|0.0919|2-Sided|95.0|0.95|1.97|||ANOVA|||RGS1; Placebo vs GSK256066 200 mcg|
1738063|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.37|Standard Error of the Mean|0.081|<|0.0934|2-Sided|95.0|0.95|1.98|||ANOVA|||RGS1; Placebo vs GSK256066 50 mcg|
1738064|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.21|Standard Error of the Mean|0.08|<|0.2967|2-Sided|95.0|0.84|1.74|||ANOVA|||RGS1; Placebo vs GSK256066 10 mcg|
1738065|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.06|Standard Error of the Mean|0.081|<|0.7393|2-Sided|95.0|0.74|1.54|||ANOVA|||RGS1; Placebo vs GSK256066 1 mcg|
1738066|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.38|Standard Error of the Mean|0.071|<|0.0539|2-Sided|95.0|0.99|1.91|||ANOVA|||PDE4A; Placebo vs GSK256066 200 mcg|
1738067|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.19|Standard Error of the Mean|0.072|<|0.2909|2-Sided|95.0|0.86|1.66|||ANOVA|||PDE4A; Placebo vs GSK256066 50 mcg|
1738068|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.18|Standard Error of the Mean|0.071|<|0.3078|2-Sided|95.0|0.86|1.63|||ANOVA|||PDE4A; Placebo vs GSK256066 10 mcg|
1738069|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.03|Standard Error of the Mean|0.072|<|0.8718|2-Sided|95.0|0.74|1.43|||ANOVA|||PDE4A; Placebo vs GSK256066 1 mcg|
1738070|NCT00464568|3199301|Superiority or Other||Treatment Ratios|2.03|Standard Error of the Mean|0.091|<|0.001||95.0|1.34|3.08|||ANOVA|||NR4A2; Placebo vs GSK256066 200 mcg|
1738071|NCT00464568|3199301|Superiority or Other||Treatment Ratios|2.16|Standard Error of the Mean|0.092|<|0.0004|2-Sided|95.0|1.42|3.3|||ANOVA|||NR4A2; Placebo vs GSK256066 50 mcg|
1738072|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.87|Standard Error of the Mean|0.091|<|0.0033|2-Sided|95.0|1.24|2.83|||ANOVA|||NR4A2; Placebo vs GSK256066 10 mcg|
1738073|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.54|Standard Error of the Mean|0.092|<|0.0448|2-Sided|95.0|1.01|2.34|||ANOVA|||NR4A2; Placebo vs GSK256066 1 mcg|
1738074|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.56|Standard Error of the Mean|0.063|<|0.0027|2-Sided|95.0|1.17|2.08|||ANOVA|||IRS2; Placebo vs GSK256066 200 mcg|
1738075|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.74|Standard Error of the Mean|0.064|<|0.0003|2-Sided|95.0|1.3|2.33|||ANOVA|||IRS2; Placebo vs GSK256066 50 mcg|
1738076|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.55|Standard Error of the Mean|0.063|<|0.0029|2-Sided|95.0|1.17|2.07|||ANOVA|||IRS2; Placebo vs GSK256066 10 mcg|
1738077|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.55|Standard Error of the Mean|0.064|<|0.0034|2-Sided|95.0|1.16|2.07|||ANOVA|||IRS2; Placebo vs GSK256066 1 mcg|
1738078|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.55|Standard Error of the Mean|0.043|<|0.0001|2-Sided|95.0|1.28|1.89|||ANOVA|||FOSL2; Placebo vs GSK256066 200 mcg|
1738079|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.68|Standard Error of the Mean|0.043|<|0.0001|2-Sided|95.0|1.38|2.05|||ANOVA|||FOSL2; Placebo vs GSK256066 50 mcg|
1738080|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.52|Standard Error of the Mean|0.043|<|0.0001|2-Sided|95.0|1.25|1.85|||ANOVA|||FOSL2; Placebo vs GSK256066 10 mcg|
1738081|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.49|Standard Error of the Mean|0.043|<|0.0001|2-Sided|95.0|1.22|1.81|||ANOVA|||FOSL2; Placebo vs GSK256066 1 mcg|
1738082|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.75|Standard Error of the Mean|0.049|<|0.0001|2-Sided|95.0|1.4|2.18|||ANOVA|||DUSP1; Placebo vs GSK256066 200 mcg|
1738083|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.74|Standard Error of the Mean|0.05|<|0.0001|2-Sided|95.0|1.38|2.17|||ANOVA|||DUSP1; Placebo vs GSK256066 50 mcg|
1738084|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.55|Standard Error of the Mean|0.049|<|0.0002|2-Sided|95.0|1.24|1.93|||ANOVA|||DUSP1; Placebo vs GSK256066 10 mcg|
1738085|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.45|Standard Error of the Mean|0.049|<|0.0015|2-Sided|95.0|1.16|1.82|||ANOVA|||DUSP1; Placebo vs GSK256066 1 mcg|
1738086|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.42|Standard Error of the Mean|0.037|<|0.0001|2-Sided|95.0|1.2|1.68|||ANOVA|||CREM; Placebo vs GSK256066 200 mcg|
1738087|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.2|Standard Error of the Mean|0.037|<|0.0325|2-Sided|95.0|1.02|1.43|||ANOVA|||CREM; Placebo vs GSK256066 50 mcg|
1738088|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.19|Standard Error of the Mean|0.037|<|0.0383|2-Sided|95.0|1.01|1.41|||ANOVA|||CREM; Placebo vs GSK256066 10 mcg|
1738089|NCT00464568|3199301|Superiority or Other||Treatment Ratios|1.14|Standard Error of the Mean|0.037|<|0.1351|2-Sided|95.0|0.96|1.35|||ANOVA|||CREM; Placebo vs GSK256066 1 mcg|
1738090|NCT00464490|3199304|Superiority or Other|||||||0.02||||||P-value <0.05 was considered significant|t-test, 2 sided|||H(0): Ventilator time (DG) = Ventilator time (CG)|
1738091|NCT00464308|3199318|Non-Inferiority or Equivalence|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.061|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.|
1738092|NCT00464308|3199319|Non-Inferiority or Equivalence|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.053|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.|
1738093|NCT00464308|3199320|Non-Inferiority or Equivalence|The sample size calculation was based upon the number of patients acheiveing complete resolution of HEARTBURN. A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.051|||<|0.05||95.0||||All statistical tests were interpreted at the 5% significance level (2-tailed).|non-inferiority||Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.|
1738094|NCT00464308|3199323|Non-Inferiority or Equivalence|A sample size of 450 subjects per arm will give a 90% power (with a one-sided 95% confidence interval and a minimal clinically important difference of 9%) to demonstrate non-inferiority of rabeprazole 20mg to esomeprazole 40mg with respect to the number of patients with complete resolution of heartburn with or without regurgitation at week 4|Proportion difference|-0.11|||<|0.05||95.0||||Adjustment for multiple comparisons was not made. The a priori threshold for statistical significance was p<0.05. Tests were 2-sided except for the non-inferiority test which was 1-sided.|Non-inferiority||Assumed that the true resolution rates in the rab20 and eso40 groups would be 30% (0.3). Non inferiority was considered proven if the lower confidence interval of the one sided 95% CI of P(rab20)-P(e40) was above -9%|Primary endpoints were assessed using non-inferiority tests. See below.|
1738095|NCT00464269|3199346|Non-Inferiority or Equivalence|The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.|% reduction over Placebo|4.1|||=|0|2-Sided|95.0|-8.1|15.0|||ANCOVA|Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to 7-day duration.|The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.|The treatment difference between each Brivaracetam dose an Placebo is reported as a percent reduction over Placebo. The treatment effect was estimated using 95 % confidence intervals.|
1738096|NCT00464269|3199346|Non-Inferiority or Equivalence|The overall significance level was controlled at 5 %. The 3 doses of Brivaracetam were tested at the 5 % level against Placebo starting from the 50 mg dose then the 20 mg dose and finally the 5 mg dose, only moving to the next test if the previous one is significant at the 5 % level.|% reduction over Placebo|12.8|||=|0|2-Sided|95.0|1.7|22.6|||ANCOVA|Baseline and Treatment Period Partial Onset Seizure (POS) frequencies are standardized to a 7-day duration.|The log-transformed (log(x+1)) POS seizure frequency was analyzed using an ANCOVA model, including terms for treatment, stratification factors, and log-transformed Baseline POS seizure frequency per week as a covariate.|The treatment difference between each Brivaracetam (BRV) dose and Placebo (PBO) is reported as a percent reduction over Placebo. The treatment effect was estimated using the 95 % confidence intervals.|
1738097|NCT00464204|3199361|Superiority or Other||Mean Difference (Final Values)|-331.0|Standard Deviation|1033.0||0.0185|2-Sided|95.0|-640.0|-21.0||One-sided t-test assuming unequal variances (as variances were significantly different between treatment groups).No multiple comparisons were made. A priori threshold for statistical significance for the confirmatory analysis on FAS: 0.025 one-sided.|t-test, 1 sided||Considered difference: Voluven® minus NaCl 0.9 %|"Null-hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization in patients treated with Voluven® is higher than or equal to this amount in patients treated with NaCl.~Alternative hypothesis: The amount of study drug required to achieve initial hemodynamic stabilization is lower in patients treated with Voluven® than in patients treated with NaCl."|
1738098|NCT00463788|3199385|Superiority or Other||Hazard Ratio (HR)|0.754||||0.5993|2-Sided|95.0|0.262|2.17|||Log Rank||||
1738099|NCT00463788|3199386|Superiority or Other||Hazard Ratio (HR)|0.821||||0.3121|2-Sided|95.0|0.561|1.204|||Log Rank||||
1738100|NCT00463788|3199387|Superiority or Other||Hazard Ratio (HR)|0.675||||0.0324|2-Sided|95.0|0.47|0.969|||Log Rank||||
1738101|NCT00463788|3199388|Superiority or Other||Odds Ratio (OR)|2.126||||0.1109|2-Sided|95.0|0.809|5.591|||Cochran-Mantel-Haenszel|Randomization strata: first- or second line according to Interactive Voice Response System (IVRS).|||
1738102|NCT00463385|3199453|Superiority or Other (legacy)|||||||0.758|||||||Fisher Exact||||
1738105|NCT00463047|3199474|Superiority or Other||Odds Ratio (OR)|1.5841|||<|0.0001|2-Sided|95.0|1.4|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.|
1738106|NCT00463047|3199475|Superiority or Other||Odds Ratio (OR)|1.8908|||<|0.0001|2-Sided|95.0|1.7|2.2|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A cumulative logit link function and independent working correlation were applied in this model. Treatment differences for each time point were measured across all categories of responses.|
1738107|NCT00463047|3199476|Superiority or Other||Odds Ratio (OR)|0.9249||||0.5808|2-Sided|95.0|0.7|1.2|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1738108|NCT00463047|3199477|Superiority or Other||Odds Ratio (OR)|1.1448||||0.2184|2-Sided|95.0|0.9|1.4|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1738109|NCT00463047|3199478|Superiority or Other||Odds Ratio (OR)|1.3426||||0.0044|2-Sided|95.0|1.1|1.6|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1738110|NCT00463047|3199479|Superiority or Other||Odds Ratio (OR)|1.4396||||0.0006|2-Sided|95.0|1.2|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1738111|NCT00463047|3199480|Superiority or Other||Odds Ratio (OR)|1.4481||||0.0191|2-Sided|95.0|1.1|2.0|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1738112|NCT00463047|3199481|Superiority or Other||Odds Ratio (OR)|1.1485||||0.5145|2-Sided|95.0|0.8|1.7|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1738113|NCT00463047|3199482|Superiority or Other||Odds Ratio (OR)|0.5355||||0.3288|2-Sided|95.0|0.2|1.9|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1738114|NCT00463047|3199483|Superiority or Other||Odds Ratio (OR)|0.9491||||0.711|2-Sided|95.0|0.7|1.3|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1738115|NCT00463047|3199484|Superiority or Other||Odds Ratio (OR)|1.0788||||0.5283|2-Sided|95.0|0.9|1.4|||Generalize estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1738116|NCT00463047|3199485|Superiority or Other||Odds Ratio (OR)|1.3184||||0.0084|2-Sided|95.0|1.1|1.6|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1738117|NCT00463047|3199486|Superiority or Other||Odds Ratio (OR)|1.4631||||0.0008|2-Sided|95.0|1.2|1.8|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1738118|NCT00463047|3199487|Superiority or Other||Odds Ratio (OR)|1.4042||||0.0268|2-Sided|95.0|1.0|1.9|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1738119|NCT00463047|3199488|Superiority or Other||Odds Ratio (OR)|1.5054||||0.3022|2-Sided|95.0|0.7|3.3|||Generalized estimating equation|||Analysis is based on a generalized estimating equation model with treatment as a fixed effect and patient as a random effect. A logit link function and compound symmetry working correlation were applied in this model.|
1738120|NCT00463047|3199490|Superiority or Other||Mean Difference (Final Values)|0.69|Standard Error of the Mean|0.16|<|0.0001||95.0|0.55|0.83||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA||||
1738121|NCT00463047|3199491|Superiority or Other|||||||0.0074|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.|||
1738122|NCT00463047|3199492|Superiority or Other|||||||0.0004|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.|||
1738123|NCT00463047|3199493|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.|||
1738124|NCT00463047|3199494|Superiority or Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.|||
1738125|NCT00463047|3199495|Superiority or Other|||||||0.0275|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.|||
1738126|NCT00463047|3199496|Superiority or Other|||||||0.1966|||||||Wilcoxon (Mann-Whitney)|P-value for the treatment comparison is from a one-sample Wilcoxon signed rank test.|||
1738127|NCT00463047|3199497|Superiority or Other||Mean Difference (Final Values)|0.93|Standard Error of the Mean|0.34|<|0.0001|2-Sided|95.0|0.7|1.16|||ANOVA||||
1738129|NCT00463047|3199505|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.13|<|0.0001|2-Sided|95.0|0.08|0.25||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID60 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.|
1738130|NCT00463047|3199506|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.12|<|0.0001|2-Sided|95.0|0.2|0.35||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID45 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.|
1738131|NCT00463047|3199507|Superiority or Other||Mean Difference (Final Values)|0.37|Standard Error of the Mean|0.09|<|0.0001||95.0|0.3|0.45||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.|
1738132|NCT00463047|3199508|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.04|<|0.0001|2-Sided|95.0|0.05|0.13||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID10 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.|
1738133|NCT00463047|3199509|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.03||0.0081|2-Sided|95.0|0.01|0.05||LS mean, SE of LS mean and p-value for treatment comparison are from ANOVA based on individual episodes with treatment as randomized, phase, and sequence as fixed factors and patient as random factor, using compound symmetry.|ANOVA|||The statistical hypothesis to be tested was: HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID5 for double-blind episodes for which patients use FBT and OXY, respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.|
1738134|NCT00463047|3199510|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.07|<|0.0001||95.0|0.18|0.29|||Mixed effects ANOVA|Crossover analysis||The statistical hypothesis to be tested was:HO: µFBT = µOXY versus Ha: µFBT ≠ µoxy where µFBT and µOXY denote the mean PID15 for double-blind episodes for which patients use FBT and oxycodone (OXY), respectively. The primary variable was analyzed using a mixed effects ANOVA crossover model, with treatment as randomized (FBT or OXY), period, and treatment sequence (as randomized) as fixed factors and patient as a random factor, using compound symmetry for the variance-covariance matrix.|
1738135|NCT00462839|3199536|Superiority or Other|||||||0.89|||||||Chi-squared, Corrected||||
1738136|NCT00462839|3199537|Superiority or Other|||||||0.72|||||||Chi-squared, Corrected||||
1738137|NCT00462839|3199538|Superiority or Other|||||||0.76|||||||Chi-squared, Corrected||||
1738138|NCT00462839|3199539|Superiority or Other||||||<|0.05||||||Post-hoc comparison of 500ml, 1000ml and 2000ml volumes were greater in the non-calibrated drape first group. Post-hoc comparisons made using Bonferroni correct t-test for 8 comparisons.|ANOVA|||Repeated measures ANOVA comparing all levels of blood estimation (P=0.0002). Post-hoc comparisons using Bonferroni corrects t-tests.|
1738139|NCT00462748|3199552|Superiority or Other||||||<|0.001||||||Hochberg’s FDR was used to power the study; the power was based on a two-sided p value of 0.025.|Regression, Logistic|The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.||Ho is no difference in proportion achieving the target of LDL-C < 2mmol/l.. 240 patients per group give a power of at least 85% to detect a 15% difference in this proportion, assuming the percentage decrease from baseline in LDL-C was 25% in the E/S group and 15% in the two comparator groups. A two-sided 0.025 test to allow for multiple comparisons was used.|
1738140|NCT00462748|3199552|Superiority or Other||||||<|0.001||||||Hochberg’s FDR was used to power the study; the power was based on a two-sided p value of 0.025.|Regression, Logistic|The logistic regression model included terms for treatment and stratum; treatment by stratum interaction was assessed.||Ho is no difference in proportion achieving the target of LDL-C < 2mmol/l.. 240 patients per group give a power of at least 85% to detect a 15% difference in this proportion, assuming the percentage decrease from baseline in LDL-C was 25% in the E/S group and 15% in the two comparator groups. A two-sided 0.025 test to allow for multiple comparisons was used.|
1738141|NCT00462670|3199571|Superiority or Other||Mean Difference (Final Values)|-1.73|Standard Error of the Mean|0.45|<|0.0001|2-Sided|95.0|-2.54|-0.92|||t-test, 2 sided||||
1738142|NCT00462670|3199572|Superiority or Other||Mean Difference (Final Values)|-1.09|Standard Error of the Mean|0.25|<|0.0001|2-Sided|95.0|-1.58|-0.6|||t-test, 2 sided||||
1738143|NCT00462644|3199574|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1738144|NCT00462644|3199575|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1738145|NCT00462644|3199576|Superiority or Other|||||||0.022|||||||t-test, 2 sided|||Normality was tested using the Kolmogorow-Smirnov test.|
1738146|NCT00462644|3199577|Superiority or Other|||||||0.007|||||||t-test, 2 sided||||
1738147|NCT00462644|3199578|Superiority or Other|||||||0.011|||||||t-test, 2 sided||||
1738148|NCT00462644|3199579|Superiority or Other|||||||0.007|||||||t-test, 2 sided||||
1738149|NCT00462306|3199629|Superiority or Other|||||||0.01|||||||Chi-squared, Corrected||||
1738150|NCT00462306|3199630|Superiority or Other|||||||0.001||||||4000 parturients and 500 non-pregnant achieves 90% power to detect a difference of 3% positive Berlin Questionnaire rates between pregnant and non-pregnant women using a two sided chi squared test at a significance level of 0.05|Chi-squared, Corrected|||We hypothesized that the rate of positive Berlin questionnaires would be higher in pregnant women compared to age matched controls undergoing surgery.|
1738151|NCT00462280|3199656|Superiority or Other|||||||0.61|||||||Wilcoxon (Mann-Whitney)||||
1738152|NCT00462228|3199658|Superiority or Other|||||||0.45||||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Oral Score.|
1738153|NCT00462228|3199658|Superiority or Other|||||||0.37||||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Oral Score.|
1738154|NCT00462228|3199658|Superiority or Other|||||||0.75||||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Oral Score.|
1738155|NCT00462228|3199658|Superiority or Other|||||||0.34||||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Oral Score.|
1738156|NCT00462228|3199659|Superiority or Other|||||||0.46||||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Written Score.|
1738157|NCT00462228|3199659|Superiority or Other|||||||0.31||||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Written Score.|
1738158|NCT00462228|3199659|Superiority or Other|||||||0.51||||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the SDMT Written Score.|
1738159|NCT00462228|3199659|Superiority or Other|||||||0.75||||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the SDMT Written Score.|
1738160|NCT00462228|3199660|Superiority or Other|||||||0.95||||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVMT-R delayed recall scores.|
1738161|NCT00462228|3199660|Superiority or Other|||||||0.37||||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R delayed recall scores.|
1738162|NCT00462228|3199660|Superiority or Other|||||||0.55||||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVMT-R delayed recall scores.|
1738163|NCT00462228|3199660|Superiority or Other|||||||0.34||||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R delayed recall scores.|
1738164|NCT00462228|3199661|Superiority or Other|||||||0.91||||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVLT-R total recall scores.|
1738165|NCT00462228|3199661|Superiority or Other|||||||0.54||||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall scores.|
1738166|NCT00462228|3199661|Superiority or Other|||||||1||||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for BVLT-R total recall scores.|
1738167|NCT00462228|3199661|Superiority or Other|||||||0.34||||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for BVMT-R total recall scores.|
1738168|NCT00462228|3199662|Superiority or Other|||||||0.64||||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part B.|
1738169|NCT00462228|3199662|Superiority or Other|||||||0.17||||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part B.|
1738170|NCT00462228|3199662|Superiority or Other|||||||1||||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part B.|
1738171|NCT00462228|3199662|Superiority or Other|||||||0.55||||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part B.|
1738172|NCT00462228|3199663|Superiority or Other|||||||0.57||||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part A.|
1738173|NCT00462228|3199663|Superiority or Other|||||||0.81||||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part A.|
1738174|NCT00462228|3199663|Superiority or Other|||||||0.55||||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for the Trail Making Test Part A.|
1738175|NCT00462228|3199663|Superiority or Other|||||||1||||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for the Trail Making Test Part A.|
1738176|NCT00462228|3199664|Superiority or Other|||||||0.027||||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R delayed recall scores.|
1738177|NCT00462228|3199664|Superiority or Other|||||||0.06||||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R delayed recall scores.|
1738178|NCT00462228|3199664|Superiority or Other|||||||0.022||||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R delayed recall scores.|
1738179|NCT00462228|3199664|Superiority or Other|||||||0.23||||||6 week comparison,alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R delayed recall scores|
1738180|NCT00462228|3199665|Superiority or Other|||||||0.43||||||12 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis:The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R total recall learning scores.|
1738181|NCT00462228|3199665|Superiority or Other|||||||0.45||||||6 week comparison, alpha = 0.05.|Wilcoxon (Mann-Whitney)|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall learning scores.|
1738182|NCT00462228|3199665|Superiority or Other|||||||1||||||12 week comparison, alpha = 0.05.|Sign test|||Null hypothesis:The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 12 weeks for HVLT-R total recall learning scores.|
1738183|NCT00462228|3199665|Superiority or Other|||||||0.55||||||6 week comparison, alpha = 0.05.|Sign test|||Null hypothesis: The change from baseline occurring with memantine is equal to the change from baseline occurring with placebo at 6 weeks for HVLT-R total recall learning scores.|
1738184|NCT00461981|3199676|Non-Inferiority or Equivalence|Equivalence|||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1738185|NCT00461981|3199681|Superiority or Other||GMT Ratio|0.66||||||95.0|0.25|1.73||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738186|NCT00461981|3199682|Superiority or Other||GMT Ratio|0.8||||||95.0|0.22|3.63||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738187|NCT00461981|3199683|Superiority or Other||GMT Ratio|4.0||||||95.0|4.0|4.0||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738188|NCT00461981|3199684|Superiority or Other||GMT Ratio|0.51||||||95.0|0.23|1.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738189|NCT00461981|3199685|Superiority or Other||GMT Ratio|0.89||||||95.0|0.7|1.0||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738190|NCT00461981|3199686|Superiority or Other||GMT Ratio|2.46||||||95.0|1.26|5.06||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738191|NCT00461981|3199687|Superiority or Other||GMT Ratio|0.44||||||95.0|0.16|1.07||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738248|NCT00461552|3199786|Other|||||||0.4||||||Treatment time month interaction|Mixed Models Analysis||||
1738249|NCT00461552|3199787|Superiority|||||||0.84||||||Treatment time month interaction|Mixed Models Analysis||||
1743518|NCT00413283|3206867|Superiority or Other|||||||1|||||||Fisher Exact||||
1738192|NCT00461981|3199688|Superiority or Other||GMT Ratio|1.35||||||95.0|0.58|3.04||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738193|NCT00461981|3199689|Superiority or Other||GMT Ratio|3.31||||||95.0|1.46|7.54||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738194|NCT00461981|3199690|Superiority or Other||GMT Ratio|4.85||||||95.0|2.51|9.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738195|NCT00461981|3199691|Superiority or Other||GMT Ratio|0.11||||||95.0|0.05|0.22||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738196|NCT00461981|3199692|Superiority or Other||GMT Ratio|0.23||||||95.0|0.15|0.35||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738197|NCT00461981|3199693|Superiority or Other||Rate difference|-20.0||||||95.0|-71.6|33.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738198|NCT00461981|3199694|Superiority or Other||Rate difference|-9.5||||||95.0|-65.2|58.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738199|NCT00461981|3199695|Superiority or Other||Rate difference|0.0||||||95.0|-97.5|84.2||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738200|NCT00461981|3199696|Superiority or Other||Rate difference|33.3||||||95.0|-81.1|90.6||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738201|NCT00461981|3199697|Superiority or Other||Rate difference|-22.4||||||95.0|-54.4|12.2||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738202|NCT00461981|3199698|Superiority or Other||Rate difference|21.9||||||95.0|-6.7|48.1||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738203|NCT00461981|3199699|Superiority or Other||Rate difference|-8.3||||||95.0|-38.5|14.5||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738204|NCT00461981|3199700|Superiority or Other||Rate difference|-37.0||||||95.0|-57.8|-17.5||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738205|NCT00461981|3199701|Superiority or Other||Rate difference|-0.6||||||95.0|-30.4|30.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738206|NCT00461981|3199702|Superiority or Other||Rate difference|65.0||||||95.0|34.4|85.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738207|NCT00461981|3199703|Superiority or Other||Rate difference|-25.0||||||95.0|-57.2|4.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738208|NCT00461981|3199704|Superiority or Other||Rate differences|-45.9||||||95.0|-71.7|-11.6||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738209|NCT00461981|3199705|Superiority or Other||GMT Ratio|0.62||||||95.0|0.33|1.16||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738210|NCT00461981|3199706|Superiority or Other||GMT Ratio|1.49||||||95.0|0.8|2.69||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738211|NCT00461981|3199707|Superiority or Other||GMT Ratio|1.75||||||95.0|0.88|3.39||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738212|NCT00461981|3199708|Superiority or Other||GMT Ratio|1.45||||||95.0|0.8|2.66||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738213|NCT00461981|3199709|Superiority or Other||GMT Ratio|0.48||||||95.0|0.27|0.87||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738214|NCT00461981|3199710|Superiority or Other||GMT Ratio|2.4||||||95.0|1.48|3.97||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738215|NCT00461981|3199711|Superiority or Other||GMT Ratio|0.58||||||95.0|0.31|1.12||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738216|NCT00461981|3199712|Superiority or Other||GMT Ratio|1.06||||||95.0|0.56|1.96||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738217|NCT00461981|3199713|Superiority or Other||GMT ratio|3.26||||||95.0|1.44|7.19||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738218|NCT00461981|3199714|Superiority or Other||GMT Ratio|3.36||||||95.0|1.54|7.13||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738219|NCT00461981|3199715|Superiority or Other||GMT Ratio|0.2||||||95.0|0.09|0.48||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738220|NCT00461981|3199716|Superiority or Other||GMT ratio|0.43||||||95.0|0.24|0.87||||||Corresponding two-sided 95% CIs based on 10,000 bootstrap data sets for the ratios of strain-specific GMTs (FluMist/TIV) were constructed by drawing replicates with replacement from each of the 2 cells (2 treatment groups) of observed data. The number of replicates drawn from each cell in this fashion was equal to the observed sample size within each cell. For each of the 10,000 bootstrap data sets, the overall GMT ratio was calculated.|
1738250|NCT00461500|3199803|Superiority or Other||Mean Difference (Net)|7.23|Standard Error of the Mean|17.6||0.683||95.0|-27.96|42.43|||ANCOVA||mean difference = drug SFC 100 minus FP 100||
1738221|NCT00461981|3199717|Superiority or Other||Rate differences|-15.8||||||95.0|-40.7|8.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738222|NCT00461981|3199718|Superiority or Other||Rate differences|11.7||||||95.0|-13.0|34.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738223|NCT00461981|3199719|Superiority or Other||Rate differences|38.1||||||95.0|0.9|65.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738224|NCT00461981|3199720|Superiority or Other||Rate differences|14.7||||||95.0|-6.5|38.4||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738225|NCT00461981|3199721|Superiority or Other||Rate differences|-5.0||||||95.0|-27.7|16.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738226|NCT00461981|3199722|Superiority or Other||Rate differences|35.7||||||95.0|9.5|57.1||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738227|NCT00461981|3199723|Superiority or Other||Rate differences|-5.6||||||95.0|-27.4|13.3||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738228|NCT00461981|3199724|Superiority or Other||Rate differences|-18.2||||||95.0|-40.0|4.9||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738229|NCT00461981|3199725|Superiority or Other||Rate differences|16.2||||||95.0|-17.6|45.4||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738230|NCT00461981|3199726|Superiority or Other||Rate differences|44.2||||||95.0|12.0|67.8||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738231|NCT00461981|3199727|Superiority or Other||Rate differences|-60.9||||||95.0|-83.8|-26.0||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738232|NCT00461981|3199728|Superiority or Other||Rate differences|-60.6||||||95.0|-79.7|-31.7||||||The seroconversion rates (the proportions of baseline seronegative subjects achieving a 4 or more fold increase in titer from baseline) were summarized for baseline seronegative subjects by treatment group and by dose number. A two-sided exact 95% confidence interval (CI) was constructed on the rate differences using the unconditional exact method proposed by Chan and Zhang (Chan, 1999).|
1738233|NCT00461786|3199737|Superiority or Other||Overall Response Rate|21.0||||||95.0|10.5|35.0||||||Overall Response Rate is the total percentage of participants with either a complete response or a partial response (CR+PR)/48 X 100.|
1738234|NCT00461734|3199738|Superiority or Other|||||||0.8779|||||||Wilcoxon (Mann-Whitney)||||
1738235|NCT00461734|3199739|Superiority or Other|||||||0.9719|||||||Wilcoxon (Mann-Whitney)||||
1738236|NCT00461734|3199741|Superiority or Other|||||||0.1852|||||||t-test, 2 sided||||
1738237|NCT00461734|3199742|Superiority or Other|||||||0.0525|||||||t-test, 2 sided||||
1738238|NCT00461734|3199746|Superiority or Other|||||||0.6151|||||||Wilcoxon (Mann-Whitney)||||
1738239|NCT00461734|3199747|Superiority or Other|||||||0.8868|||||||Wilcoxon (Mann-Whitney)||||
1738240|NCT00461734|3199748|Superiority or Other|||||||0.548|||||||Wilcoxon (Mann-Whitney)||||
1738241|NCT00461734|3199749|Superiority or Other|||||||0.2257|||||||Wilcoxon (Mann-Whitney)||||
1738242|NCT00461734|3199750|Superiority or Other|||||||0.338|||||||two-sided z-test||||
1738243|NCT00461734|3199751|Superiority or Other|||||||0.4347|||||||two-sided z-test||||
1738244|NCT00461708|3199752|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1738245|NCT00461708|3199753|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1738246|NCT00461591|3199784|Superiority||Hazard Ratio (HR)|0.77||||0.0412|2-Sided|95.0|0.59|0.99|||Log Rank||||
1738251|NCT00461331|3199804|Superiority or Other||Mean Difference (Net)|6.7|Standard Deviation|2.35||0.55||95.0|4.4|9.4|||Regression, Linear||This was for test period 1 between days 3 and 5 after the last pump infusion line change.|All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson’s correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.|
1738252|NCT00461331|3199805|Superiority or Other||Mean Difference (Net)|5.35|Standard Deviation|4.165||0.15||95.0|0.97|9.23|||Regression, Linear||This was between days 3 and 5 after the last pump infusion line change using Insulin Aspart and Insulin Lispro. Adequate samples were not available to do the analysis for day 2.|All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson’s correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables.|
1738253|NCT00461331|3199806|Superiority or Other||Mean Difference (Final Values)|96.4|Standard Deviation|8.5||0.52||95.0|87.9|100.0|||Regression, Linear|7 patients underwent early termination of either one or both of their test period due to loss of glycemic control||Glucose levels for patients when they were on each insulin were analyzed. All data was analyzed on an intention to treat basis. Repeated measures, paired t-test and Pearson’s correlation on SPSS 14.0 for windows and statistical R-package were used to compare the various variables. This was a pilot study.|
1738254|NCT00461305|3199843|Superiority or Other||Incidence on one treatment arm|7.1||||||95.0|1.98|17.29||||||Exact 95% confident intervals were calculated using F-distribution by treatment group.|
1738255|NCT00461305|3199843|Superiority or Other||Incidence on one treatment arm|13.4|||||2-Sided|95.0|9.73|17.77|||||No group comparison were planned. Binomial parameter on each treatment arm was estimated by exact method.|Exact 95% confident intervals were calculated using F-distribution by treatment group. If the upper confidence limit is lower than 27.56% (threshold incidence), the treatment arm will be concluded to be acceptable. No group comparison was planned.|
1738256|NCT00461253|3199848|Non-Inferiority or Equivalence|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.9|||||2-Sided|95.0|0.58|1.41|||||"Breast cancer OR for current use of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis, crude"|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.|
1738257|NCT00461253|3199848|Non-Inferiority or Equivalence|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.85|||||2-Sided|95.0|0.52|1.39|||||"Breast cancer OR for current use of LNG-IUD vs. Cu-IUD at time of breast cancer diagnosis; adjusted for BMI, family history of breast cancer, age at first birth, age at first menarche, physical activity (primary analysis)"|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.|
1738258|NCT00461253|3199848|Non-Inferiority or Equivalence|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|1.04|||||2-Sided|95.0|0.93|1.17|||||Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD, crude|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.|
1738259|NCT00461253|3199848|Non-Inferiority or Equivalence|Assuming a prevalence of current Mirena use among fertile women of 8% in Finland and 2% in Germany, it was estimated that 3,500 cases and 14,000 controls would be needed to exclude a 1.5-fold breast cancer risk for Mirena users compared with users of copper IUDs.|Odds Ratio (OR)|0.99|||||2-Sided|95.0|0.88|1.12|||||Breast cancer OR for ever use of LNG-IUD vs. Cu-IUD; adjusted for BMI, family history of breast cancer, age at first birth, age at menarche and physical activity (primary analysis)|In this matched case-control study, conditional logistic regression was used to investigate the relationship between a woman being a breast cancer case or a control (dichotomous dependent variable), and a set of actual or potential prognostic factors (covariates) for breast cancer (incl. the use of Mirena). Conditional logistic regression uses a maximum likelihood approach for estimating the covariates; data are stratified and the likelihoods are computed relative to each stratum.|
1738260|NCT00461175|3199849|Superiority or Other||Hazard Ratio (HR)|0.16|||||2-Sided|95.0|0.1|0.25|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, and parity.||
1738261|NCT00461175|3199849|Superiority or Other||Pearl Index|0.52|||||2-Sided|95.0|0.42|0.64|||||||
1738262|NCT00461175|3199849|Superiority or Other||Pearl Index|0.06|||||2-Sided|95.0|0.04|0.09|||||||
1738263|NCT00461175|3199850|Non-Inferiority or Equivalence|Sample size calculations were based on a two group test of equivalence in proportions. These calculations are based on the following assumptions: 1) one sided α of 0.025; 2) power (1-β) of 0.80; 3) non-inferiority limit on hazard ratio of 2; and 4) an incidence of 0.5 and 1.0 per 1000 insertions.|Hazard Ratio (HR)|1.65|||||2-Sided|95.0|0.99|2.78|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, time since last delivery, experience of the inserting health care provider.|The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.|
1738308|NCT00459706|3200076|Superiority or Other|||||||0.15|||||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738264|NCT00461175|3199850|Non-Inferiority or Equivalence|Sample size calculations were based on a two group test of equivalence in proportions. These calculations are based on the following assumptions: 1) one sided α of 0.025; 2) power (1-β) of 0.80; 3) non-inferiority limit on hazard ratio of 2; and 4) an incidence of 0.5 and 1.0 per 1000 insertions.|Hazard Ratio (HR)|1.61|||||2-Sided|95.0|0.96|2.7|||||Hazard ratio was adjusted for the following prognostic factors: age, BMI, breastfeeding at time of insertion and parity status.|The null hypothesis to be tested was: The perforation incidence ratio for LNG IUS vs. copper IUD is higher than or equal to 2.|
1738265|NCT00461123|3199851|Superiority or Other||Mean Difference (Net)|-2.61||||0.7878||95.0|-22.03|16.82|||ANCOVA|Analysis of variance (ANOVA), treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group|
1738266|NCT00461123|3199852|Superiority or Other||Mean Difference (Final Values)|-6.5||||0.0588||95.0|-13.25|0.26|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90|
1738267|NCT00461123|3199853|Superiority or Other||Mean Difference (Final Values)|5.57||||0.4162||95.0|-8.21|19.35|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90|
1738268|NCT00461123|3199854|Superiority or Other||Mean Difference (Final Values)|-0.27||||0.87||95.0|-3.58|3.04|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of LS means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90|
1738269|NCT00461123|3199855|Superiority or Other||Mean Difference (Final Values)|1.93||||0.5248||95.0|-4.18|8.05|||ANCOVA|Analysis of covariance (ANCOVA), baseline as covariate, treatment as fixed factor|Difference of least squares (LS) means (Placebo minus Vardenafil)|null hypothesis: mean of Vardenafil group equals mean of Placebo group at day +90|
1738270|NCT00461097|3199861|Superiority or Other||Risk Difference (RD)|27.5||||0.025|2-Sided|95.0|4.3|43.9||No adjustments were made to the p-value.|Barnard's statistic|The a priori threshold for statistical significance is 0.05.||Number of participants who successfully consumed 10,000 mg of egg white solid was compared using Barnard’s statistic with the null hypothesis that there was no difference between treatment groups.|
1738271|NCT00460811|3199880|Superiority or Other|||||||0.0008|||||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.|
1738272|NCT00460811|3199880|Superiority or Other||||||<|0.0001|||||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.|
1738273|NCT00460811|3199880|Superiority or Other||||||<|0.0036|||||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.|
1738274|NCT00460811|3199880|Superiority or Other||||||<|0.0002|||||||ANCOVA|||For each of the 4 active linaclotide groups, the null hypothesis was that there was no difference between placebo and the dose group in the change from baseline in the weekly normalized CSBM Rate. An observed cases (OC) approach to missing post-baseline data was applied: any missing data were not imputed.|
1738275|NCT00460798|3199885|Superiority or Other||Obective Response Rate (Percent)|40.6|||||2-Sided|95.0|35.5|46.0|||||Exact method based on binomial distribution|Objective Response Rate (ORR) = Percentage of participants with best overall response of CR or PR|
1738276|NCT00460655|3199908|Superiority or Other||Mean Difference (Net)|-3.428||||0.006||95.0|-5.841|-1.016|||t-test, 2 sided||||
1738277|NCT00460603|3199910|Superiority or Other||Hazard Ratio (HR)|0.941||||0.414|2-Sided|95.0|0.535|1.653|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).|
1738278|NCT00460603|3199910|Superiority or Other||Hazard Ratio (HR)|1.203||||0.7364|2-Sided|95.0|0.676|2.141|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).|
1738279|NCT00460603|3199910|Superiority or Other||Hazard Ratio (HR)|1.155||||0.6904|2-Sided|95.0|0.656|2.033|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).|
1738280|NCT00460603|3199911|Superiority or Other||Hazard Ratio (HR)|1.25||||0.8065|2-Sided|95.0|0.75|2.07|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).|
1738281|NCT00460603|3199911|Superiority or Other||Hazard Ratio (HR)|1.12||||0.6648|2-Sided|95.0|0.66|1.89|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).|
1738309|NCT00459706|3200077|Superiority or Other|||||||0.461|||||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738310|NCT00459706|3200077|Superiority or Other|||||||0.843|||||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738282|NCT00460603|3199911|Superiority or Other||Hazard Ratio (HR)|1.4||||0.8884|2-Sided|95.0|0.81|2.41|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).|
1738283|NCT00460603|3199912|Superiority or Other||Hazard Ratio (HR)|1.49||||0.8746|2-Sided|95.0|0.75|2.98|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).|
1738284|NCT00460603|3199912|Superiority or Other||Hazard Ratio (HR)|0.73||||0.2167|2-Sided|95.0|0.33|1.61|||Log Rank|||Hazard ratio and corresponding 95% CI was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).|
1738285|NCT00460603|3199912|Superiority or Other||Hazard Ratio (HR)|1.08||||0.5699|2-Sided|95.0|0.47|2.45|||Log Rank|||Hazard ratio and corresponding 95% confidence interval (CI) was calculated based on the Cox proportional hazards model stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no). One-sided p-value was derived from the log-rank test stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no).|
1738286|NCT00460603|3199944|Superiority or Other||Risk Ratio (RR)|0.797||||0.8192|2-Sided|95.0|0.489|1.299|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.|
1738287|NCT00460603|3199944|Superiority or Other||Risk Ratio (RR)|0.735||||0.8391|2-Sided|95.0|0.399|1.352|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes vs. no) and prior pelvic irradiation (yes vs. no) was used for the analysis.|
1738288|NCT00460603|3199944|Superiority or Other||Risk Ratio (RR)|0.585||||0.9726|2-Sided|95.0|0.332|1.031|||Cochran-Mantel-Haenszel|||One-sided Cochran-Mantel-Haenszel test of treatment stratified by prior adjuvant chemotherapy (yes versus [vs.] no) and prior pelvic irradiation (yes vs. no) was used for the analysis.|
1738289|NCT00460564|3199972|Superiority or Other||Mean Difference (Net)|-6.83|||<|0.001||95.0|-10.567|-3.093|||t-test, 2 sided||||
1738290|NCT00460525|3199984|Superiority or Other||Vaccine Efficacy, VE=1-RR=1-exp(ß)|0.2||||0.068||95.0|-0.02|0.37||The a priori threshold for statistical significance was set at 0.05.|Poisson regression|No adjustments|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Poisson model fit.|Incidence density, defined as number of clinical malaria episodes per PYAR, was compared using Poisson regression. The null hypothesis of no vaccine efficacy was tested. The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.|
1738291|NCT00460525|3199986|Superiority or Other||Vaccine Efficacy, VE=1-RR=1-exp(ß)|0.17||||0.175||95.0|-0.09|0.37||The a priori threshold for statistical significance was set at 0.05.|Regression, Cox|No adjustments were made.|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.|Time to first clinical malaria episode with significant parasitemia (2500/mm^3) and temperature of greater than or equal to 37.5 degrees C was analyzed by fitting a Cox Proportional Hazards model. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.|
1738292|NCT00460265|3200025|Superiority or Other||Hazard Ratio (HR)|0.78||||||95.0|0.659|0.922|||||Cox proportional hazards model stratified by IVRS randomization factors||
1738293|NCT00460265|3200029|Superiority or Other||Odds Ratio (OR)|1.69||||||95.0|1.15|2.44|||||||
1738294|NCT00460265|3200029|Superiority or Other||Difference in percentages|10.98||||||95.0|3.13|18.68|||||||
1738295|NCT00460265|3200030|Superiority or Other||Hazard Ratio (HR)|0.873||||0.1403||95.0|0.729|1.046|||Log Rank|Stratified by IVRS randomization factors (ECOG(0:1),previously treated w/ CT/RT(yes:no),primary tumor site(oropharynx/larynx:oral cavity/hypopharynx))|Hazard ratio from Cox proportional hazards model stratified by IVRS randomization factors; hazard ratio presented as panitumumab plus chemotherapy:chemotherapy alone.||
1738296|NCT00459732|3200069|Superiority or Other|||||||0.16|||||||ANCOVA|Repeated measures analysis of variance adjusted for baseline osteocalcin level.|||
1738297|NCT00459732|3200070|Superiority or Other|||||||0.44|||||||ANOVA|Repeated measures|||
1738298|NCT00459732|3200071|Superiority or Other|||||||0.13|||||||ANOVA||||
1738299|NCT00459706|3200072|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738300|NCT00459706|3200072|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738301|NCT00459706|3200073|Superiority or Other|||||||0.656|||||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738302|NCT00459706|3200073|Superiority or Other|||||||0.934|||||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738303|NCT00459706|3200074|Superiority or Other|||||||0.656|||||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738304|NCT00459706|3200074|Superiority or Other|||||||0.934|||||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738305|NCT00459706|3200075|Superiority or Other|||||||0.656|||||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738306|NCT00459706|3200075|Superiority or Other|||||||0.934|||||||Cochran-Mantel-Haenszel|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738307|NCT00459706|3200076|Superiority or Other|||||||0.002|||||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738311|NCT00459706|3200078|Superiority or Other|||||||0.006|||||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738312|NCT00459706|3200078|Superiority or Other|||||||0.784|||||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738313|NCT00459706|3200079|Superiority or Other|||||||0.035|||||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738314|NCT00459706|3200079|Superiority or Other|||||||0.466|||||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738315|NCT00459706|3200080|Superiority or Other|||||||0.483|||||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738316|NCT00459706|3200080|Superiority or Other|||||||0.838|||||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738317|NCT00459706|3200081|Superiority or Other|||||||0.73|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738318|NCT00459706|3200081|Superiority or Other|||||||0.033|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738319|NCT00459706|3200082|Superiority or Other|||||||0.736|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738320|NCT00459706|3200082|Superiority or Other|||||||0.049|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738321|NCT00459706|3200083|Superiority or Other|||||||0.019|||||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738322|NCT00459706|3200083|Superiority or Other|||||||0.018|||||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738323|NCT00459706|3200084|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738324|NCT00459706|3200084|Superiority or Other||||||<|0.038|||||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738325|NCT00459706|3200085|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738326|NCT00459706|3200085|Superiority or Other||||||<|0.023|||||||Kruskal-Wallis|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738327|NCT00459706|3200086|Superiority or Other|||||||0.459|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738328|NCT00459706|3200086|Superiority or Other|||||||0.652|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738329|NCT00459706|3200087|Superiority or Other|||||||0.459|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738330|NCT00459706|3200087|Superiority or Other|||||||0.652|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738331|NCT00459706|3200088|Superiority or Other|||||||0.459|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738332|NCT00459706|3200088|Superiority or Other|||||||0.652|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738333|NCT00459706|3200089|Superiority or Other|||||||0.015|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738334|NCT00459706|3200089|Superiority or Other|||||||0.069|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738335|NCT00459706|3200090|Superiority or Other|||||||0.015|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738336|NCT00459706|3200090|Superiority or Other|||||||0.069|||||||Chi-squared|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738337|NCT00459706|3200091|Superiority or Other|||||||0.166|||||||ANOVA|||p-value for statistical difference between 3 clusters in the Prefilled Syringe group|
1738338|NCT00459706|3200091|Superiority or Other|||||||0.896|||||||ANOVA|||p-value for statistical difference between 3 clusters in the Autoinjector group|
1738339|NCT00459706|3200092|Superiority or Other||Odds Ratio (OR)|0.4|||<|0.001|2-Sided|95.0|0.29|0.56|||GEE model+logit link+multinomial distrib||||
1738340|NCT00459706|3200093|Superiority or Other||Odds Ratio (OR)|0.3|||<|0.001|2-Sided|95.0|0.21|0.42|||GEE model+logit link+multinomial distrib||||
1738341|NCT00459706|3200094|Superiority or Other||Odds Ratio (OR)|1.74||||0.001|2-Sided|95.0|1.25|2.42|||GEE model+logit link+multinomial distrib||||
1738342|NCT00459706|3200095|Superiority or Other||Odds Ratio (OR)|0.82||||0.196|2-Sided|95.0|0.61|1.11|||GEE model+logit link+multinomial distrib||||
1738343|NCT00459706|3200096|Superiority or Other||Odds Ratio (OR)|0.27|||<|0.001|2-Sided|95.0|0.2|0.36|||GEE model+logit link+multinomial distrib||||
1738344|NCT00459706|3200097|Superiority or Other||Odds Ratio (OR)|0.26|||<|0.001|2-Sided|95.0|0.19|0.36|||GEE model+logit link+multinomial distrib||||
1738345|NCT00459706|3200098|Superiority or Other||Odds Ratio (OR)|0.25|||<|0.001|2-Sided|95.0|0.18|0.34|||GEE model+logit link+multinomial distrib||||
1738346|NCT00459706|3200099|Superiority or Other||Odds Ratio (OR)|1.88|||<|0.001|2-Sided|95.0|1.35|2.62|||GEE model+logit link+multinomial distrib||||
1738347|NCT00459706|3200100|Superiority or Other||Odds Ratio (OR)|3.08|||<|0.001|2-Sided|95.0|2.23|4.25|||GEE model+logit link+multinomial distrib||||
1738348|NCT00459706|3200101|Superiority or Other||Odds Ratio (OR)|2.14|||<|0.001|2-Sided|95.0|1.57|2.91|||GEE model+logit link+multinomial distrib||||
1738349|NCT00459706|3200102|Superiority or Other||Odds Ratio (OR)|2.1|||<|0.001|2-Sided|95.0|1.53|2.88|||GEE model+logit link+multinomial distrib||||
1738350|NCT00459706|3200103|Superiority or Other||Odds Ratio (OR)|0.66||||0.014|2-Sided|95.0|0.47|0.92|||GEE model+logit link+multinomial distrib||||
1738351|NCT00459706|3200104|Superiority or Other||Odds Ratio (OR)|0.63||||0.007|2-Sided|95.0|0.45|0.88|||GEE model+logit link+multinomial distrib||||
1738352|NCT00459706|3200105|Superiority or Other||Odds Ratio (OR)|0.64||||0.009|2-Sided|95.0|0.46|0.89|||GEE model+logit link+multinomial distrib||||
1738353|NCT00459706|3200106|Superiority or Other||Odds Ratio (OR)|0.67||||0.022|2-Sided|95.0|0.47|0.94|||GEE model+logit link+multinomial distrib||||
1738354|NCT00459706|3200107|Superiority or Other||Odds Ratio (OR)|0.57|||<|0.001|2-Sided|95.0|0.41|0.78|||GEE model+logit link+multinomial distrib||||
1738355|NCT00459706|3200108|Superiority or Other||Odds Ratio (OR)|1.65||||0.002|2-Sided|95.0|1.21|2.24|||GEE model+logit link+multinomial distrib||||
1738356|NCT00459706|3200109|Superiority or Other||Odds Ratio (OR)|1.35||||0.112|2-Sided|95.0|0.93|1.96|||GEE model+logit link+multinomial distrib||||
1738357|NCT00459706|3200110|Superiority or Other||Odds Ratio (OR)|1.32||||0.106|2-Sided|95.0|0.94|1.85|||GEE model+logit link+multinomial distrib||||
1738358|NCT00459706|3200111|Superiority or Other||Odds Ratio (OR)|1.25||||0.184|2-Sided|95.0|0.9|1.72|||GEE model+logit link+multinomial distrib||||
1738359|NCT00459706|3200112|Superiority or Other||Odds Ratio (OR)|2.0|||<|0.001|2-Sided|95.0|1.44|2.78|||GEE model+logit link+multinomial distrib||||
1738360|NCT00459706|3200113|Superiority or Other||Odds Ratio (OR)|2.06|||<|0.001|2-Sided|95.0|1.5|2.83|||GEE model+logit link+multinomial distrib||||
1738361|NCT00459706|3200114|Superiority or Other||Odds Ratio (OR)|2.39|||<|0.001|2-Sided|95.0|1.65|3.46|||GEE model+logit link+multinomial distrib||||
1738362|NCT00459706|3200115|Superiority or Other||Odds Ratio (OR)|1.92||||0.002|2-Sided|95.0|1.26|2.92|||GEE model+logit link+multinomial distrib||||
1738363|NCT00459706|3200116|Superiority or Other||Odds Ratio (OR)|1.61||||0.007|2-Sided|95.0|1.14|2.29|||GEE model+logit link+multinomial distrib||||
1738364|NCT00459706|3200117|Superiority or Other||Odds Ratio (OR)|1.85|||<|0.001|2-Sided|95.0|1.33|2.57|||GEE model+logit link+multinomial distrib|||Day 84|
1738365|NCT00459706|3200118|Superiority or Other||Mean Difference (Net)|0.12|Standard Error of the Mean|0.19||0.519|2-Sided|95.0|-0.25|0.5|||ANOVA||||
1738366|NCT00459706|3200119|Superiority or Other||Mean Difference (Net)|-0.01|Standard Error of the Mean|0.19||0.965|2-Sided|95.0|-0.39|0.37|||ANOVA||||
1738367|NCT00459706|3200120|Superiority or Other||Mean Difference (Net)|0.22|Standard Error of the Mean|0.17||0.212|2-Sided|95.0|-0.12|0.56|||ANOVA||||
1738368|NCT00459706|3200121|Superiority or Other||Mean Difference (Net)|-0.41|Standard Error of the Mean|0.29||0.154|2-Sided|95.0|-0.97|0.15|||ANOVA||||
1738369|NCT00459706|3200122|Superiority or Other||Regression coefficient|-0.15||||0.465|2-Sided|95.0|-0.55|0.25|||Regression, Linear|||Prior Injection Experience versus No Prior Injection Experience (reference)|
1738370|NCT00459706|3200123|Superiority or Other||Regression coefficient|1.72||||0.541|2-Sided|95.0|-0.82|4.25|||Regression, Linear|||At least 4 DMARDs versus 1 DMARD (reference).|
1738371|NCT00459706|3200123|Superiority or Other||Regression coefficient|-0.14||||0.541|2-Sided|95.0|-0.97|0.68|||Regression, Linear|||3 DMARDs versus 1 DMARD (reference).|
1738372|NCT00459706|3200123|Superiority or Other||Regression coefficient|-0.1||||0.541|2-Sided|95.0|-0.52|0.32|||Regression, Linear|||2 DMARDs versus 1 DMARD (reference).|
1738373|NCT00459706|3200124|Superiority or Other||Regression coefficient|-0.39||||0.012|2-Sided|95.0|-0.69|-0.09|||Regression, Linear|||All categories, by 1-unit increments.|
1738374|NCT00459706|3200125|Superiority or Other||Regression coefficient|0.01||||0.819|2-Sided|95.0|-0.1|0.12|||Regression, Linear|||All categories|
1738375|NCT00459706|3200126|Superiority or Other||Regression coefficient|-0.08||||0.105|2-Sided|95.0|-0.18|0.02|||Regression, Linear|||All categories|
1738376|NCT00459706|3200127|Superiority or Other||Regression coefficient|0.03||||0.749|2-Sided|95.0|-0.15|0.21|||Regression, Linear|||All categories|
1738377|NCT00459706|3200128|Superiority or Other||Regression coefficient|0.06||||0.278|2-Sided|95.0|-0.05|0.18|||Regression, Linear|||All categories|
1738378|NCT00459706|3200129|Superiority or Other||Regression coefficient|-0.6||||0.006|2-Sided|95.0|-1.03|-0.18|||Regression, Linear|||Self-injection Experience versus No Self-injection Experience (reference).|
1738379|NCT00459706|3200130|Superiority or Other||Regression coefficient|0.17||||0.03|2-Sided|95.0|0.02|0.32|||Regression, Linear|||All categories|
1738380|NCT00459706|3200131|Superiority or Other||Regression coefficient|-0.35||||0.008|2-Sided|95.0|-0.61|-0.09|||Regression, Linear|||All categories|
1738381|NCT00459706|3200132|Superiority or Other||Regression coefficient|-0.28||||0.02|2-Sided|95.0|-0.52|-0.05|||Regression, Linear|||All categories|
1738382|NCT00459706|3200133|Superiority or Other||Regression coefficient|0.0||||0.676|2-Sided|95.0|-0.59|0.6|||Regression, Linear|||Participants at University Level versus participants with only Reading/Writing Capacity (reference).|
1738383|NCT00459706|3200133|Superiority or Other||Regression coefficient|-0.18||||0.676|2-Sided|95.0|-0.62|0.26|||Regression, Linear|||Participants at High School/Baccalaureate Level versus participants with only Reading/Writing Capacity (reference).|
1738384|NCT00459706|3200134|Superiority or Other||Regression coefficients|-0.75||||0.001|2-Sided|95.0|-1.2|-0.29|||Regression, Linear|||Female versus male (reference).|
1738385|NCT00459706|3200135|Superiority or Other||Regression coefficient|0.11||||0.16|2-Sided|95.0|-0.04|0.27|||Regression, Linear|||All categories|
1738386|NCT00459706|3200136|Superiority or Other||Odds Ratio (OR)|1.96||||0.019|2-Sided|95.0|1.12|3.43|||GEE Model+Logit Link+Binomial Distributn||||
1738387|NCT00459706|3200137|Superiority or Other||Odds Ratio (OR)|1.73||||0.058|2-Sided|95.0|0.98|3.05|||GEE Model+Logit Link+Binomial Distributn|GEE=Generalized estimating equation Distribn=distribution|||
1738388|NCT00459706|3200138|Non-Inferiority or Equivalence|"The non-inferiority test was performed using the 95% two-sided CI of the difference (AI minus PFS) of mean subject satisfactions (α = 2.5%).~Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI > -1."|Mean Difference (Net)|1.25|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|0.85|1.64|||ANOVA|||"Non-inferiority of AI over PFS was assessed on the primary endpoint. The hypotheses tested was as follows:~H0: AI – PFS ≤ -1 H1: AI – PFS > -1"|
1738412|NCT00458406|3200235|Superiority or Other (legacy)||||||>|0.05|||||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar effi cacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."|
1738389|NCT00459706|3200139|Non-Inferiority or Equivalence|"The non-inferiority test was performed using the 95 percent (%) two-sided confidence interval (CI) of the difference (AI minus PFS) of mean subject satisfactions (α = 2.5%).~Non-inferiority was demonstrated if the lower limit of the two-sided 95% CI > -1."|Mean Difference (Net)|1.11|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|0.71|1.5|||ANOVA|ANOVA=analysis of variance||Non-inferiority of autoinjector (AI) over prefilled syringe (PFS) was assessed on the primary endpoint. Hypothesis tested was H0: AI minus PFS less than or equal to (≤) -1. The alternate hypothesis was H1: AI minus PFS greater than (>) -1.|
1738390|NCT00459667|3200143|Superiority or Other||number of patients w/ IS reactions.|31.7||||||95.0|24.9|39.0||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.|
1738391|NCT00459667|3200143|Superiority or Other||number of patients w/ IS reactions.|26.2||||||95.0|22.8|29.8||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.|
1738392|NCT00459667|3200143|Superiority or Other||number of patients w/ IS reactions.|31.7||||||95.0|28.0|35.7||||||The 95% Confidence Interval was calculated for number of patients w/ Injection-site (IS) reactions.|
1738393|NCT00459667|3200144|Superiority or Other||Number of patients w/ Flu-Like-Syndrome|31.1||||||95.0|24.4|38.4||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome|
1738394|NCT00459667|3200144|Superiority or Other||Number of patients w/ Flu-Like-Syndrome|15.8||||||95.0|13.1|18.9||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome|
1738395|NCT00459667|3200144|Superiority or Other||Number of patients w/ Flu-Like-Syndrome|17.4||||||95.0|14.4|20.7||||||The 95% Confidence Interval was calculated for number of patients w/ Flu-Like-Syndrome|
1738396|NCT00459355|3200165|Superiority or Other|||||||0.002|||||||MANCOVA||||
1738397|NCT00459355|3200166|Superiority or Other||||||<|0.0001|||||||MANCOVA||||
1738398|NCT00459355|3200167|Superiority or Other||||||<|0.0001|||||||MANCOVA||||
1738399|NCT00459316|3200184|Superiority or Other|||||||0.01||||||Two sided-p-value <0.05 was specified as statistically significant a priori. No adjustment for multiple primary outcomes was made.|Fisher Exact|||The null hypothesis was that there were no differences between CD4% strata.|
1738400|NCT00459316|3200185|Superiority or Other|||||||0.03||||||Two-sided p-value <0.05 was specified as statistically significant a priori. There were no adjustments for multiple outcomes.|Fisher Exact|||The null hypothesis was that there would be no difference between CD4% strata.|
1738401|NCT00459290|3200193|Superiority or Other|||||||0.0648|||||||Log Rank||||
1738402|NCT00459290|3200194|Superiority or Other|||||||0.1545|||||||Log Rank||||
1738403|NCT00459290|3200195|Superiority or Other|||||||0.7912|||||||Log Rank||||
1738404|NCT00459134|3200203|Superiority or Other||Mean Difference (Final Values)|4.49|Standard Error of the Mean|1.73||0.01|2-Sided|95.0|1.09|7.89||This p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.||The null hypothesis was that quality of life would be the same in both groups at 12 weeks. A mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.|
1738405|NCT00459134|3200204|Superiority or Other||Mean Difference (Final Values)|0.66|Standard Error of the Mean|1.19||0.576|2-Sided|95.0|-1.67|3.0||This p-value is not adjusted for multiple comparisons.|Mixed Models Analysis|Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups.||The null hypothesis is that sexual function will be the same in both groups at 12 weeks. A Mixed effect repeated measures model constrained such that the baseline means were equal in the two groups was used to test this hypothesis.|
1738406|NCT00458406|3200229|Superiority or Other (legacy)||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."|
1738407|NCT00458406|3200230|Superiority or Other (legacy)||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||"Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."|
1738408|NCT00458406|3200232|Superiority or Other (legacy)||||||<|0.05|||||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."|
1738409|NCT00458406|3200232|Superiority or Other (legacy)||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Mann-Whitney test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP. The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD.|
1738410|NCT00458406|3200233|Superiority or Other (legacy)||||||>|0.05|||||||Chi-squared|||"Chi-Square test. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."|
1738411|NCT00458406|3200234|Superiority or Other (legacy)||||||>|0.05|||||||t-test, 2 sided|||"Two-sided t-test. We hypothesized that Bi-Flex would result in improved adherence but similar effi cacy to CPAP.~The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% CI for the difference between the 2 means had a range of 1.282 SD."|
1738468|NCT00457301|3200373|Superiority or Other (legacy)|||||||0.34|||||||ANCOVA|||ANCOVA adjuusting for baseline HADS anxiety scores|
1743519|NCT00413283|3206868|Superiority or Other|||||||1|||||||Fisher Exact||||
1738413|NCT00458406|3200236|Superiority or Other (legacy)|||||||0.512|||||||t-test, 2 sided|||"We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.~Description of power calculation: The study sample size of 45 in the Bi-Flex group and 15 in the CPAP group had 80% power to detect an effect size ≥ 0.85 with a 0.05 two-sided significance level. In addition, with this sample size, the 95% confidence interval (CI) for the difference between the 2 means had a range of 1.282 standard deviation (SD)."|
1738414|NCT00458393|3200237|Superiority||Hazard Ratio (HR)|0.61||||0.09|2-Sided|95.0|0.34|1.09|||Log Rank||||
1738415|NCT00458393|3200238|Superiority||Hazard Ratio (HR)|1.2||||0.41|2-Sided|95.0|0.8|1.7|||Log Rank||||Details in the manuscript https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3956614/
1738416|NCT00458393|3200239|Superiority or Other||Hazard Ratio (HR)|1.13||||0.3|2-Sided|95.0|0.89|1.43|||Log Rank|||Null hypothesis of no difference between the arms|
1738417|NCT00458393|3200240|Superiority or Other||Risk Difference (RD)|-0.008||||0.68|2-Sided|95.0|-0.047|0.03|||Chi-squared|||Null is no difference between arms|
1738418|NCT00458393|3200241|Superiority||Median Difference (Final Values)|0.0||||0.76|2-Sided|95.0|-0.42|0.42||Not adjusted for multiple comparisons, a priori threshold for statistical significance, p < 0.05|Wilcoxon (Mann-Whitney)||||Full details available in the methods section of https://www.ncbi.nlm.nih.gov/pubmed/24367497
1738419|NCT00458393|3200242|Superiority||Mean Difference (Final Values)|0.0||||0.99|2-Sided|||||Not adjusted for multiple comparisons and the a priori threshold for statistical significance was p < 0.05|Wilcoxon (Mann-Whitney)||||
1738420|NCT00458393|3200243|Superiority||Mean Difference (Net)|0.25||||0.7|2-Sided|95.0|-1.1|1.6|||t-test, 2 sided||||Detailed methods and results are available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110718/
1738421|NCT00458393|3200244|Superiority or Other||Mean Difference (Net)|-0.005||||0.53|2-Sided|95.0|-0.02|0.01|||Mixed Models Analysis|||Null hypothesis is equal proportion of pills returned|
1738422|NCT00458393|3200245|Superiority||Mean Difference (Net)|-7.0||||0.32|2-Sided|95.0|-69.0|54.0|||Mixed Models Analysis||||
1738423|NCT00458393|3200246|Superiority or Other||Risk Ratio (RR)|1.0||||1|2-Sided||||||Fisher Exact|||Null hypothesis is the proportion of mutations is identical.|Detailed resistance data is found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4176446/
1738424|NCT00458393|3200247|Superiority||Mean Difference (Net)|0.08||||0.56|2-Sided|95.0|-0.18|0.33|||t-test, 2 sided||||
1738425|NCT00458393|3200248|Superiority||Median Difference (Net)|-2.2||||0.19|2-Sided|95.0|-5.5|1.1|||median regression||||
1738426|NCT00458393|3200249|Superiority||Median Difference (Net)|0.0||||1|2-Sided|95.0|-9.3|9.3|||median regression||||
1738427|NCT00458393|3200250|Superiority||Median Difference (Net)|-3.8||||0.009|2-Sided|95.0|-6.6|-0.95|||median regression||||
1738428|NCT00458393|3200251|Superiority||Mean Difference (Net)|-0.91||||0.001|2-Sided|||||< 0.05 for statistical significance. no adjustment for multiple comparisons|Mixed Models Analysis||||
1738429|NCT00458393|3200252|Superiority|Desc|Risk Difference (RD)|0.0||||1|2-Sided||||||Fisher Exact||||
1738430|NCT00458393|3200252|Superiority or Other|||||||1|||||||Fisher Exact|||Null hypothesis of no difference|
1738431|NCT00458393|3200253|Superiority||Hazard Ratio (HR)|0.99||||0.92|2-Sided|95.0|0.79|1.23|||Log Rank||||
1738432|NCT00458393|3200254|Superiority||Hazard Ratio (HR)|0.89||||0.5|2-Sided|95.0|0.65|1.23|||Log Rank||||
1738433|NCT00458393|3200255|Superiority||Risk Ratio (RR)|1.3||||0.54|2-Sided|95.0|0.57|2.96|||Fisher Exact||||
1738434|NCT00458393|3200256|Superiority||Risk Ratio (RR)|1.33||||0.28|2-Sided|95.0|0.79|2.25||p-value is not adjusted for multiple comparisons, a priori threshold for statistical significance was p < 0.05|Fisher Exact||||Extensive analysis and methods published in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966916/
1738435|NCT00458393|3200257|Superiority or Other||Hazard Ratio (HR)|0.577|Standard Error of the Mean|0.105||0.002|2-Sided|95.0|0.404|0.824||secondary p-value given.|Log Rank|stratified by site|Efron correction for ties. Placebo is reference. Results typically quoted as efficacy = 100*(1-HR)|Primary null hypothesis: Relative hazard of 0.7 or less. Secondary null hypothesis: Relative hazard of 1.0 or less.|
1738436|NCT00458341|3200273|Other|||||||0.518|||||||Chi-squared|||Analysis of Cycle 2 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.|
1738437|NCT00458341|3200273|Other|||||||0.021|||||||Chi-squared|||Analysis of Cycle 2 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.|
1738438|NCT00458341|3200273|Other|||||||0.021|||||||Chi-squared|||Analysis of Cycle 1 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.|
1738439|NCT00458341|3200273|Other|||||||0.021|||||||Chi-squared|||Analysis of Cycle 1 data. Analysis was to compare the observed rate with the null hypothesis response rate of 10%.|
1738440|NCT00458341|3200274|Other|||||||0.592||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 2 versus Day 14 of Cycle 2|
1738441|NCT00458341|3200274|Other|||||||0.123||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 2 versus Day 14 of Cycle 2|
1738442|NCT00458341|3200274|Other|||||||0.19||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 1 versus Day 14 of Cycle 1|
1738443|NCT00458341|3200274|Other|||||||0.133||||||Threshold for significance at 0.05 level.|t-test, 2 sided|||Baseline of Cycle 1 versus Day 14 of Cycle 1|
1738444|NCT00458302|3200284|Superiority or Other||Difference in proportion of response|1.29|||||2-Sided|95.0|-7.99|10.58|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.||
1738469|NCT00457301|3200374|Superiority or Other (legacy)||Slope|0.28|Standard Error of the Mean|0.1||0.05||95.0|||||ANCOVA|||Sample size was calculated based on the EQ-5D index score. To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error and 80% power.|
1738470|NCT00457197|3200379|Superiority or Other|||||||0.2473|||||||ANCOVA|||Baseline PACS used as a covariate.|
1738471|NCT00457197|3200380|Superiority or Other|||||||0.8814|||||||ANCOVA|||Baseline YMRS used as a covariate.|
1738472|NCT00457197|3200381|Superiority or Other|||||||0.2569|||||||ANCOVA|||Baseline IDS-SR used as a covariate.|
1738445|NCT00458302|3200286|Non-Inferiority or Equivalence|If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.|Difference in proportion of response|-1.0|||||2-Sided|95.0|-9.9|7.8|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment are, so 250 patients in total.|
1738446|NCT00458302|3200287|Non-Inferiority or Equivalence|The primary comparison was performed at Week 48. If at Week 48, the lower limit of the 95% two-sided confidence interval of the difference between DRV/r and DRV/r+2NRTIs exceeds -12%, non-inferiority of the DRV/r 800/100 once a day (O.D) monotherapy versus the DRV/r 800/100 mg O.D. plus two NRTIs triple combination therapy was concluded.|Difference in proportion of response|-1.6|||||2-Sided|95.0|-10.1|6.8|||||Difference in proportion of response DRV/r minus DRV/r+2NRTIs.|Assuming a virologic response rate of 90% at 48 weeks for both treatment arms, 111 patients were required per treatment arm to establish non-inferiority of DRV/r versus triple regimen with a maximum allowable difference of 12%, with a one-sided significance level of p=0.025 and 80% power. To account for a maximum of 10% major protocol violations that would be excluded from the on-protocol analysis, 125 patients were recruited in each treatment arm, so 250 patients in total.|
1738447|NCT00457821|3200310|Superiority or Other||||||<|0.05||||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.|
1738448|NCT00457821|3200312|Superiority or Other||||||<|0.05||||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.|
1738449|NCT00457821|3200313|Superiority or Other||||||<|0.05||||||There was no adjustment for multiple comparisons.|Mixed Models Analysis|||Within-dose group and between-dose group analyses were performed, using a linear mixed effect model with baseline, dose, and period as fixed effects and subject as a random effect.|
1738450|NCT00457743|3200321|Superiority or Other||CBR rate (percentage)|40.0||||||95.0|22.7|59.4|||||The clinical benefit response (CBR) rate, defined as the percentage of the subjects confirmed with CR, PR, or SD>=22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).||
1738451|NCT00457743|3200330|Superiority or Other||Objective Response Rate(percentage)|13.3||||||95.0|3.8|30.7|||||The subjects confirmed with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).||
1738452|NCT00457743|3200332|Superiority or Other||Disease control Rate (percentage)|56.7||||||95.0|37.4|74.5|||||The disease control rate, defined as the percentage of subjects confirmed with CR, PR, and SD >=10 weeks on study according to RECIST.||
1738453|NCT00457730|3200343|Superiority or Other|||||||0.074|||||||t-test, 2 sided||||
1738454|NCT00457730|3200344|Superiority or Other|||||||0.002|||||||t-test, 2 sided||||
1738455|NCT00457730|3200345|Superiority or Other|||||||0.016|||||||t-test, 2 sided||||
1738456|NCT00457691|3200352|Superiority or Other||Hazard Ratio (HR)|1.171||||0.9163|2-Sided|95.0|0.936|1.466||p-value from 1-sided log-rank test, stratified by ECOG performance status, organ sites with disease, primary tumor site, prior adjuvant treatment|Log Rank||||
1738457|NCT00457691|3200353|Superiority or Other||Hazard Ratio (HR)|1.095||||0.8072|2-Sided|95.0|0.892|1.344||p-value from 1-sided log-rank test, stratified by Eastern Cooperative Oncology Group (ECOG) performance status, organ sites with disease, primary tumor site, prior adjuvant treatment|Log Rank||||
1738458|NCT00457665|3200354|Superiority|||||||0.94|||||||Mixed Models Analysis||||
1738459|NCT00457639|3200355|Superiority||Mean Difference (Final Values)|11.4||||0.45|2-Sided|95.0|-17.7|50.8|||Mixed Models Analysis||||
1738460|NCT00457639|3200356|Superiority||Mean Difference (Net)|13.8||||0.42|2-Sided|95.0|-19.7|61.1|||Mixed Models Analysis||||
1738461|NCT00457392|3200367|Superiority or Other||Risk Ratio (RR)|1.514||||0.0471|2-Sided|95.0|1.002|2.289|||Cochran-Mantel-Haenszel|||The Cochran-Mantel-Haenszel (CMH) test stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and EGFR status (positive, versus negative, versus unknown) was used to compare ORR between the 2 treatment arms. The relative risk ratio estimator was used to contrast the treatment effects on response rates. A point estimate of relative risk ratio and 2-sided 95% CI was calculated.|
1738462|NCT00457392|3200368|Superiority or Other||Hazard Ratio (HR)|0.807||||0.0023|2-Sided|95.0|0.695|0.937||No p-value is adjusted for multiple comparisons for PFS.|Log Rank|One-sided log-rank test with alpha=0.025 was used.||Differences in PFS between treatment arms was analyzed by the 1-sided log rank test, stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and EGFR status (positive, versus negative, versus unknown).|
1738463|NCT00457392|3200369|Superiority or Other||Hazard Ratio (HR)|0.942||||0.1933|2-Sided|95.0|0.822|1.079||p-value was not adjusted for multiple comparisons.|Log Rank|||Differences in OS between treatment arms was analyzed by the 1-sided log rank test, stratified for smoking status (ever versus never), prior bevacizumab therapy (yes versus no) and epidermal growth factor receptor (EGFR) status (positive, versus negative, versus unknown).|
1738464|NCT00457366|3200370|Other|We used an analysis of covariance (ANCOVA) with baseline as the covariate to analyze the PANSS-EC at hour 2.|||||>|0.05|||||||ANCOVA||||
1738465|NCT00457301|3200371|Superiority or Other (legacy)||Slope|0.01|Standard Error of the Mean|0.02||0.46||95.0|||||ANCOVA|||Sample size was calculated based on the EQ-5D index score. To compare two independent means for a parallel trial design, 100 patients in each group were needed to detect a clinically important difference (CID) in EQ-5D index score (CID = 0.10, SD = 0.25) with a 5% probability of Type I error and 80% power.|
1738466|NCT00457301|3200372|Superiority or Other (legacy)||Slope|0.79|Standard Error of the Mean|0.23||0.001||95.0|||||ANCOVA||||
1738467|NCT00457301|3200373|Superiority or Other (legacy)|||||||0.55|||||||ANCOVA|||ANCOVA adjusting for baseline HADS depression scores.|
1738477|NCT00457197|3200386|Superiority or Other|||||||0.1272|||||||ANCOVA|||Baseline percent heavy drinking days included as covariate.|
1738478|NCT00457197|3200387|Superiority or Other|||||||0.4709|||||||ANCOVA|||Baseline drinks/day used as covariate.|
1738479|NCT00457015|3200390|Superiority or Other|||||||0.102||||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Log Rank|||Kaplan-Meier analysis using the Log-Rank test was used to compare the time distribution between the 2 treatment groups.|
1738480|NCT00457015|3200391|Superiority or Other|||||||0.003||||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Blocked Wilcoxon rank sum test|||The analysis compared the TOS at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the nonparametric Blocked Wilcoxon Rank Sum test because of an assumed non-normal distribution.|
1738481|NCT00457015|3200392|Superiority or Other|||||||0.01||||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Blocked Wilcoxon rank sum test|||The primary efficacy analysis compared the change from baseline in MSCS Score at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the nonparametric Blocked Wilcoxon Rank Sum test because of an assumed non-normal distribution.|
1738482|NCT00457002|3200395|Superiority or Other||Adjusted difference in event rates|0.09|||||2-Sided|95.0|-0.09|0.28|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference of event rates in thrombocytopenia.|
1738483|NCT00457002|3200395|Superiority or Other||Adjusted difference in event rates|-0.1|||||2-Sided|95.0|-0.32|0.12||||||Adjusted difference in event rates for stroke.|
1738484|NCT00457002|3200395|Superiority or Other||Adjusted difference of event rates|0.09|||||2-Sided|95.0|-0.11|0.3|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference of event rates for myocardial infarction.|
1738485|NCT00457002|3200395|Superiority or Other||Adjusted Event rate difference|0.0|||||2-Sided|95.0|-0.3|0.29|||||stratification factor: previous VTE (yes, no), and active or previous cancer (yes, no).|Adjusted difference in event rates in MI or stroke.|
1738486|NCT00457002|3200404|Superiority or Other||Risk Difference (RD)|0.2|||||2-Sided|95.0|-0.66|1.07|||||||
1738487|NCT00457002|3200404|Superiority or Other||Risk Ratio (RR)|1.1|||||2-Sided|95.0|0.74|1.61|||||||
1738488|NCT00457002|3200405|Superiority or Other||Adjusted Difference of Event Rates|0.87|||||2-Sided|95.0|-0.4|2.14|||||||
1738489|NCT00457002|3200406|Superiority or Other||Adjustted difference of event rates|0.59|||||2-Sided|95.0|-16.0|1.33||||||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).|
1738490|NCT00457002|3200407|Superiority or Other||Adjusted Difference of event rates|0.36|||||2-Sided|95.0|-0.33|1.06||||||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).|
1738491|NCT00457002|3200408|Superiority or Other||Adjusted Difference of event rates|0.29||||0.0437|2-Sided|95.0|0.01|0.57||The Mantel-Haenszel test stratified by the stratification factors will be used at the one-sided alpha=0.025 level.|Mantel Haenszel|||Adjusted difference of event rates takes the stratification factor into consideration: previous VTE (yes, no) and active or previous cancer (yes, no).|
1738492|NCT00457002|3200409|Superiority or Other||Risk Difference (RD)|-0.22|||||2-Sided|95.0|-0.47|0.03|||||||
1738493|NCT00457002|3200409|Superiority or Other||Risk Ratio (RR)|0.41|||||2-Sided|95.0|0.14|1.16|||||||
1738494|NCT00457002|3200410|Superiority or Other||Risk Difference (RD)|-0.15|||||2-Sided|95.0|-0.29|-0.02||||||Note: Relative risk was not estimable (0.0); only risk difference could be estimated.|
1738495|NCT00457002|3200411|Superiority or Other||Risk Difference (RD)|-0.14|||||2-Sided|95.0|-1.04|0.76|||||||
1738496|NCT00457002|3200411|Superiority or Other||Risk Ratio (RR)|0.94|||||2-Sided|95.0|0.65|1.37|||||||
1738497|NCT00457002|3200412|Superiority or Other||Risk Difference (RD)|-0.34|||||2-Sided|95.0|-0.62|-0.07|||||||
1738498|NCT00457002|3200412|Superiority or Other||Risk Ratio (RR)|0.31|||||2-Sided|95.0|0.11|0.83|||||||
1738499|NCT00457002|3200413|Superiority or Other||Risk Difference (RD)|-0.03|||||2-Sided|95.0|-0.26|0.2|||||||
1738500|NCT00457002|3200413|Superiority or Other||Risk Ratio (RR)|0.88|||||2-Sided|95.0|0.32|2.43|||||||
1738501|NCT00457002|3200414|Superiority or Other||Risk Difference (RD)|-0.03|||||2-Sided|95.0|-0.26|0.2|||||||
1738502|NCT00457002|3200414|Superiority or Other||Risk Ratio (RR)|0.88|||||2-Sided|95.0|0.32|2.43|||||||
1738503|NCT00457002|3200415|Superiority or Other||Risk Difference (RD)|0.28|||||2-Sided|95.0|-1.18|1.73|||||||
1738504|NCT00457002|3200415|Superiority or Other||Risk Ratio (RR)|1.04|||||2-Sided|95.0|0.84|1.28|||||||
1738505|NCT00457002|3200416|Superiority or Other||Risk Difference (RD)|-0.4|||||2-Sided|95.0|-0.78|-0.03|||||||
1738506|NCT00457002|3200416|Superiority or Other||Risk Ratio (RR)|0.5|||||2-Sided|95.0|0.26|0.96|||||||
1738507|NCT00457002|3200417|Superiority or Other||Risk Difference (RD)|-0.38|||||2-Sided|95.0|-1.25|0.48|||||||
1738508|NCT00457002|3200417|Superiority or Other||Risk Ratio (RR)|0.89|||||2-Sided|95.0|0.68|1.16|||||||
1738509|NCT00457002|3200418|Superiority or Other||Risk Difference (RD)|-0.03|||||2-Sided|95.0|-0.16|0.1|||||||
1738510|NCT00457002|3200418|Superiority or Other||Risk Ratio (RR)|0.68|||||2-Sided|95.0|0.11|4.05|||||||
1738511|NCT00457002|3200419|Superiority or Other||Risk Difference (RD)|-0.26|||||2-Sided|95.0|-1.23|0.71|||||||
1738512|NCT00457002|3200419|Superiority or Other||Risk Ratio (RR)|0.91|||||2-Sided|95.0|0.65|1.29|||||||
1738513|NCT00457002|3200420|Superiority or Other||Risk Difference (RD)|-0.12|||||2-Sided|95.0|-1.52|1.29|||||||
1738514|NCT00457002|3200420|Superiority or Other||Risk Ratio (RR)|0.98|||||2-Sided|95.0|0.79|1.22|||||||
1738515|NCT00457002|3200421|Superiority or Other||Risk Difference (RD)|-0.24|||||2-Sided|95.0|-1.65|1.17|||||||
1738516|NCT00457002|3200421|Superiority or Other||Risk Ratio (RR)|0.96|||||2-Sided|95.0|0.78|1.2|||||||
1738518|NCT00457002|3200422|Superiority or Other||Risk Ratio (RR)|1.09|||||2-Sided|95.0|0.7|1.71|||||||
1738519|NCT00457002|3200423|Superiority or Other||Risk Difference (RD)|0.1|||||2-Sided|95.0|-0.61|0.81|||||||
1738520|NCT00457002|3200423|Superiority or Other||Risk Ratio (RR)|1.06|||||2-Sided|95.0|0.69|1.63||||||Formal testing of noninferiority for the key secondary efficacy endpoint was not performed since the superiority of the primary efficacy endpoint was not demonstrated.|
1738521|NCT00457002|3200424|Superiority or Other||Risk Difference (RD)|-0.39|||||2-Sided|95.0|-1.37|0.59|||||||
1738522|NCT00457002|3200424|Superiority or Other||Risk Ratio (RR)|0.87||||0.4364|2-Sided|95.0|0.62|1.23|||Mantel Haenszel|||To conclude superiority of apixaban versus enoxaparin on the primary efficacy endpoint, the upper bound of the two-sided 95.004% confidence interval (CI) for the relative risk (pa/ pe) must be less than 1.|
1738523|NCT00456547|3200465|Superiority or Other||||||<|0.05||||||Corrected for 12 comparisons|Wilcoxon (Mann-Whitney)||||
1738524|NCT00456547|3200466|Superiority or Other||||||<|0.05||||||Corrected for 12 comparisons|t-test, 2 sided||||
1738525|NCT00456547|3200467|Superiority or Other||||||<|0.05||||||Corrected for 12 comparisons.|t-test, 2 sided||||
1738526|NCT00456547|3200468|Superiority or Other||||||<|0.05||||||Adjusted for 12 comparisons|t-test, 2 sided||||
1738527|NCT00456521|3200469|Superiority or Other||Mean Difference (Net)|-5.29|||||2-Sided|95.0|-9.16|-1.42||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1738528|NCT00456521|3200470|Superiority or Other||Mean Difference (Net)|-0.09|||||2-Sided|95.0|-0.78|0.6||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1738529|NCT00456521|3200471|Superiority or Other||Mean Difference (Net)|-0.11|||||2-Sided|95.0|-0.85|0.63||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1738530|NCT00456521|3200472|Superiority or Other||Mean Difference (Net)|0.09|||||2-Sided|95.0|-0.7|0.87||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1738531|NCT00456521|3200473|Superiority or Other||Mean Difference (Net)|1.37|||||2-Sided|95.0|0.25|2.49||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1738532|NCT00456521|3200474|Superiority or Other||Mean Difference (Net)|2.55|||||2-Sided|95.0|0.97|4.14||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1738533|NCT00456521|3200475|Superiority or Other||Mean Difference (Net)|-2.7|||||2-Sided|95.0|-7.26|1.86||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1738534|NCT00456521|3200476|Superiority or Other||Mean Difference (Net)|-1.28|||||2-Sided|95.0|-3.34|0.79||||||Due to pre-specified hypothesis testing design, no formal statistical inference testing was performed.|
1738535|NCT00456521|3200477|Superiority or Other||Mean Difference (Net)|-8.98||||0.165|2-Sided||||||ANCOVA||||
1738536|NCT00456521|3200478|Superiority or Other||Mean Difference (Net)|-13.37||||0.003|2-Sided||||||ANCOVA||||
1738537|NCT00456521|3200479|Superiority or Other||Mean Difference (Net)|3.14||||0.001|2-Sided|95.0|1.23|5.04|||ANCOVA||||
1738538|NCT00456521|3200480|Superiority or Other||Mean Difference (Net)|3.23|||<|0.001|2-Sided|95.0|1.52|4.95|||ANCOVA||||
1738539|NCT00456521|3200481|Superiority or Other||Mean Difference (Net)|-12.53||||0.003|2-Sided||||||ANCOVA||||
1738540|NCT00456521|3200482|Superiority or Other||Mean Difference (Net)|-8.11||||0.004|2-Sided||||||ANCOVA||||
1738541|NCT00456521|3200483|Superiority or Other||Mean Difference (Net)|-3.21|||<|0.001|2-Sided|95.0|-4.82|-1.6|||ANCOVA||||
1738542|NCT00456521|3200484|Superiority or Other||Odds Ratio (OR)|2.92|||<|0.001|2-Sided|95.0|1.95|4.37|||Regression, Logistic||||
1738543|NCT00456521|3200485|Superiority or Other||Odds Ratio (OR)|2.89|||<|0.001||95.0|2.02|4.13|||Regression, Logistic||||
1738544|NCT00456521|3200486|Superiority or Other||Mean Difference (Net)|-4.21|||<|0.001||95.0|-5.56|-2.86|||ANCOVA||||
1738545|NCT00456365|3200492|Superiority or Other|||||||0.21|||||||ANCOVA||||
1738546|NCT00456365|3200493|Superiority or Other|||||||0.69|||||||ANOVA||||
1738547|NCT00456365|3200494|Superiority or Other|||||||0.02|||||||ANCOVA||||
1738548|NCT00456365|3200495|Superiority or Other|||||||0.03|||||||Chi-squared||||
1738549|NCT00456092|3200519|Superiority||Adjusted Mean Difference|4.3||||0.004|2-Sided||||||ANOVA|ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors with baseline score as the covariate.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.||
1738550|NCT00456092|3200519|Superiority||Adjusted Mean Difference|3.3||||0.028|2-Sided||||||ANOVA|ANOVA model with treatment, methotrexate use, and interaction of treatment group and methotrexate use as factors and baseline score as the covariate.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.||
1738551|NCT00456092|3200521|Superiority||Adjusted Mean Difference|-1.4||||0.105|2-Sided||||||ANOVA|ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.||
1738552|NCT00456092|3200521|Superiority||Adjusted Mean Difference|-2.1||||0.016|2-Sided||||||ANOVA|ANOVA model using treatment group, methotrexate use, and interaction of treatment group and methotrexate use as factors.|The adjusted mean difference (Apremilast-Placebo) is based on an ANOVA model described above.||
1738553|NCT00456092|3200522|Superiority||Adjusted Mean Difference|2.7||||0.026|2-Sided||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Physical Component|
1738554|NCT00456092|3200522|Superiority||Adjusted Mean Difference|1.6||||0.182|2-Sided||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Physical Component|
1738555|NCT00456092|3200522|Superiority||Adjusted Mean Difference|4.1||||0.003|2-Sided||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Mental Component|
1738556|NCT00456092|3200522|Superiority||Adjusted Mean Difference|1.4||||0.308|2-Sided||||||ANOVA|ANOVA model including treatment group, methotrexate use, and baseline score.|Adjusted mean difference (Apremilast-Placebo) was based on the ANOVA model described above.|Mental Component|
1738557|NCT00456092|3200527|Superiority||Hazard Ratio (HR)|0.872||||0.836|2-Sided|95.0|0.158|4.797|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.||
1738558|NCT00456092|3200527|Superiority||Hazard Ratio (HR)|1.006||||0.984|2-Sided|95.0|0.457|2.215|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.||
1738559|NCT00456092|3200528|Superiority||Hazard Ratio (HR)|3.023||||0.026|2-Sided|95.0|1.059|8.63|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.||
1738560|NCT00456092|3200528|Superiority||Hazard Ratio (HR)|1.337||||0.253|2-Sided|95.0|0.791|2.26|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.||
1738561|NCT00456092|3200529|Superiority||Hazard Ratio (HR)|1.265||||0.283|2-Sided|95.0|0.791|2.024|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.||
1738562|NCT00456092|3200529|Superiority||Hazard Ratio (HR)|0.95||||0.65|2-Sided|95.0|0.745|1.211|||Chi-squared||Based on a proportional hazards model comparing the hazard functions associated with the treatment and placebo.||
1738563|NCT00456092|3200530|Superiority||Treatment Difference|13.53||||0.08|2-Sided||||||ANOVA|ANOVA model with treatment as the factor.|Treatment Difference = Apremilast 20 mg BID - Placebo||
1738564|NCT00456092|3200530|Superiority||Treatment Difference|11.58||||0.136|2-Sided||||||ANOVA|ANOVA model with treatment as the factor.|Treatment Difference = Apremilast 20 mg BID - Placebo||
1738565|NCT00456092|3200533|Superiority||Odds Ratio (OR)|1.04||||1|2-Sided|95.0|0.52|2.11|||Chi-squared, Corrected||||
1738566|NCT00456092|3200533|Superiority||Odds Ratio (OR)|1.32||||0.548|2-Sided|95.0|0.66|2.66|||Chi-squared, Corrected||||
1738567|NCT00456092|3200534|Superiority||Odds Ratio (OR)|1.63||||0.279|2-Sided|95.0|0.77|3.44|||Chi-squared, Corrected||||
1738568|NCT00456092|3200534|Superiority||Odds Ratio (OR)|2.06||||0.083|2-Sided|95.0|0.98|4.34|||Chi-squared, Corrected||||
1738569|NCT00456092|3200535|Superiority||Odds Ratio (OR)|1.033||||1|2-Sided|95.0|0.53|2.03|||Chi-squared, Corrected||||
1738570|NCT00456092|3200535|Superiority||Odds Ratio (OR)|1.305||||0.549|2-Sided|95.0|0.66|2.57|||Chi-squared, Corrected||||
1738571|NCT00456092|3200536|Superiority||Odds Ratio (OR)|1.98||||0.071|2-Sided|95.0|1.0|3.91|||Chi-squared, Corrected||||
1738572|NCT00456092|3200536|Superiority||Odds Ratio (OR)|1.568||||0.264|2-Sided|95.0|0.79|3.11|||Chi-squared, Corrected||||
1738573|NCT00456092|3200537|Superiority||Odds Ratio (OR)|4.12||||0.371|2-Sided|95.0|0.45|37.88|||Chi-squared, Corrected||||
1738574|NCT00456092|3200537|Superiority||Odds Ratio (OR)|5.4||||0.204|2-Sided|95.0|0.61|47.54|||Chi-squared, Corrected||||
1738575|NCT00456092|3200538|Superiority||Odds Ratio (OR)|6.95||||0.012|2-Sided|95.0|1.49|32.35|||Chi-squared, Corrected||||
1738576|NCT00456092|3200538|Superiority||Odds Ratio (OR)|5.12||||0.056|2-Sided|95.0|1.06|24.67|||Chi-squared, Corrected||||
1738577|NCT00456092|3200541|Superiority||Odds Ratio (OR)|5.77|||<|0.001|2-Sided|95.0|2.4|13.88||A p-value < 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.|Chi-squared, Corrected||||
1738578|NCT00456092|3200541|Superiority||Odds Ratio (OR)|4.19|||<|0.002|2-Sided|95.0|1.72|10.2||A p-value < 0.025 (2-sided) is considered statistically significant, after adjusting for two treatment comparisons using the Bonferroni procedure.|Chi-squared, Corrected||||
1738579|NCT00455962|3200549|Superiority|||||||0.69|||||||t-test, 2 sided|||Using previously collected data from a group of 18 predominantly Caucasian women undergoing a similar infusion we determined that 22 women would be necessary to identify a 30% difference in peak LH levels, the primary outcome measure, between AAW and CW with 80% power at a significance level of 0.05.|
1738580|NCT00455858|3200558|Superiority or Other||Least Square Mean|-72.159|||<|0.0001||95.0|-72.647|-71.671|||Paired t-test|||Estimated mean decrease in FPG at week 20|
1738581|NCT00455858|3200558|Superiority or Other||Least Square Mean|-69.553|||<|0.0001||95.0|-70.047|-69.06|||Paired t-test|||Estimated mean decrease in FPG at week 12|
1738582|NCT00455858|3200559|Superiority or Other||Least Square Mean|-1.338|||<|0.0001||95.0|-1.35|-1.327|||t-test||||
1738583|NCT00455858|3200560|Superiority or Other||Least Square Mean|-1.356|||<|0.0001||95.0|-1.368|-1.344|||t-test||||
1738584|NCT00455741|3200561|Superiority|||||||0.07||||||a priori significance set at p<0.05|t-test, 2 sided||||
1738585|NCT00455741|3200562|Superiority||||||<|0.03|||||||t-test, 2 sided||||
1738586|NCT00455741|3200563|Superiority||||||<|0.02||||||a priori threshold for significance p<0.05|t-test, 2 sided||||
1738587|NCT00455741|3200564|Superiority|||||||0.49||||||threshold for significance p<0.05|t-test, 2 sided||||
1738588|NCT00455741|3200565|Superiority||||||=|0||||||a priori significance level p<0.05|ANOVA||||
1738589|NCT00455741|3200566|Superiority||||||<|0.03||||||a priori threshold for significance is p<0.05|ANOVA|||positive feedback|
1738590|NCT00455741|3200566|Superiority or Other||||||<|0.9|||||||ANOVA|||effect of age on estrogen negative feedback ( nadir LH as % of baseline LH)|
1738591|NCT00455533|3200593|Superiority or Other||Difference (bootsrap method)|0.117|||||2-Sided|90.0|-0.218|0.469|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status|
1738592|NCT00455533|3200593|Superiority or Other||Difference (bootstrap method)|-0.09|||||2-Sided|90.0|-0.236|0.067|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status|
1738593|NCT00455533|3200593|Superiority or Other||Difference (boostrap method)|0.106|||||2-Sided|90.0|-0.073|0.291|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status|
1738594|NCT00455533|3200593|Superiority or Other||Difference (bootstrap method)|-0.29|||||2-Sided|90.0|-0.482|-0.094|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Negative Biomarker Status|
1739565|NCT00446992|3201799|Superiority or Other||||||=|0|||||||Univariate linear regression|||Baseline compared to Week 16|
1738595|NCT00455533|3200594|Superiority or Other||Difference (bootstrap method)|0.049|||||2-Sided|90.0|-0.227|0.309|||||ixabepilone - paclitaxel|Membrane Threshold/Positive Biomarker Status|
1738596|NCT00455533|3200594|Superiority or Other||Difference (bootstrap method)|-0.058|||||2-Sided|90.0|-0.167|0.053|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status|
1738597|NCT00455533|3200594|Superiority or Other||DIfference (bootstrap method)|0.009|||||2-Sided|90.0|-0.137|0.155|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker Status|
1738598|NCT00455533|3200594|Superiority or Other||Difference (bootstrap method)|-0.114|||||2-Sided|90.0|-0.258|0.22|||||ixabepilone - paclitaxel|Mem+Cyto/Negative Biomarker Status|
1738599|NCT00455533|3200595|Superiority or Other||Difference (bootstrap method)|0.116|||||2-Sided|90.0|-0.13|0.37|||||ixabepilone - paclitaxel|Membrane Threshold/Positive Biomarker Status|
1738600|NCT00455533|3200595|Superiority or Other||Difference (bootstrap method)|-0.056|||||2-Sided|90.0|-0.152|0.046|||||ixabepilone - paclitaxel|Membrane Threshold/Negative Biomarker Status|
1738601|NCT00455533|3200595|Superiority or Other||Difference (bootstrap method)|0.064|||||2-Sided|90.0|-0.064|0.197|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Positive Biomarker STatus|
1738602|NCT00455533|3200595|Superiority or Other||Difference (bootstrap method)|-0.145|||||2-Sided|90.0|-0.27|-0.017|||||ixabepilone - paclitaxel|Mem+Cyto Threshold/Negative Biomarker Status|
1738603|NCT00455533|3200596|Superiority or Other|||||||0.2016||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684_at|
1738604|NCT00455533|3200596|Superiority or Other|||||||0.0933||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684_at|
1738605|NCT00455533|3200596|Superiority or Other|||||||0.2341||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684_at|
1738606|NCT00455533|3200596|Superiority or Other|||||||0.0074||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589_at|
1738607|NCT00455533|3200596|Superiority or Other|||||||0.3946||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589_at|
1738608|NCT00455533|3200596|Superiority or Other|||||||0.0275||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589_at|
1738609|NCT00455533|3200596|Superiority or Other|||||||0.3657||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191_at|
1738610|NCT00455533|3200596|Superiority or Other|||||||0.3289||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191_at|
1738611|NCT00455533|3200596|Superiority or Other|||||||0.6596||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191_at|
1738612|NCT00455533|3200596|Superiority or Other|||||||0.1172||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664_at|
1738613|NCT00455533|3200596|Superiority or Other|||||||0.1201||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664_at|
1738614|NCT00455533|3200596|Superiority or Other|||||||0.0999||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664_at|
1738615|NCT00455533|3200596|Superiority or Other|||||||0.1213||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726_x_at|
1738616|NCT00455533|3200596|Superiority or Other|||||||0.5085||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726_x_at|
1738617|NCT00455533|3200596|Superiority or Other|||||||0.397||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726_x_at|
1738618|NCT00455533|3200596|Superiority or Other|||||||0.5398||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977_x_at|
1738619|NCT00455533|3200596|Superiority or Other|||||||0.6001||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977_x_at|
1738620|NCT00455533|3200596|Superiority or Other|||||||0.7125||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977_x_at|
1743520|NCT00413283|3206868|Superiority or Other|||||||1|||||||Fisher Exact||||
1738621|NCT00455533|3200596|Superiority or Other|||||||0.2547||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023_x_at|
1738622|NCT00455533|3200596|Superiority or Other|||||||0.0629||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023_x_at|
1738623|NCT00455533|3200596|Superiority or Other|||||||0.4076||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023_x_at|
1738624|NCT00455533|3200596|Superiority or Other|||||||0.0776||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372_x_at|
1738625|NCT00455533|3200596|Superiority or Other|||||||0.4197||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372_x_at|
1738626|NCT00455533|3200596|Superiority or Other|||||||0.2036||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372_x_at|
1738627|NCT00455533|3200596|Superiority or Other|||||||0.4676||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141_at|
1738628|NCT00455533|3200596|Superiority or Other|||||||0.2222||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141_at|
1738629|NCT00455533|3200596|Superiority or Other|||||||0.6926||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141_at|
1738630|NCT00455533|3200596|Superiority or Other|||||||0.8553||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601_s_at|
1738631|NCT00455533|3200596|Superiority or Other|||||||0.4688||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601_s_at|
1738632|NCT00455533|3200596|Superiority or Other|||||||0.7844||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601_s_at|
1738633|NCT00455533|3200596|Superiority or Other|||||||0.317||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026_x_at|
1738634|NCT00455533|3200596|Superiority or Other|||||||0.0718||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026_x_at|
1738635|NCT00455533|3200596|Superiority or Other|||||||0.1259||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026_x_at|
1738636|NCT00455533|3200596|Superiority or Other|||||||0.2866||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320_at|
1738637|NCT00455533|3200596|Superiority or Other|||||||0.0644||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320_at|
1738638|NCT00455533|3200596|Superiority or Other|||||||0.2383||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320_at|
1738639|NCT00455533|3200596|Superiority or Other|||||||0.274||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714_x_at|
1738640|NCT00455533|3200596|Superiority or Other|||||||0.0849||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714_x_at|
1738641|NCT00455533|3200596|Superiority or Other|||||||0.1231||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714_x_at|
1738642|NCT00455533|3200596|Superiority or Other|||||||0.0031||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477_s_at|
1738643|NCT00455533|3200596|Superiority or Other|||||||0.2465||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477_s_at|
1738644|NCT00455533|3200596|Superiority or Other|||||||0.0142||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477_s_at|
1738645|NCT00455533|3200596|Superiority or Other|||||||0.1071||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476_s_at|
1738646|NCT00455533|3200596|Superiority or Other|||||||0.0675||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476_s_at|
1738647|NCT00455533|3200596|Superiority or Other|||||||0.1657||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476_s_at|
1738648|NCT00455533|3200596|Superiority or Other|||||||0.0396||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733_at|
1738649|NCT00455533|3200596|Superiority or Other|||||||0.6578||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733_at|
1738650|NCT00455533|3200596|Superiority or Other|||||||0.0849||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733_at|
1738651|NCT00455533|3200596|Superiority or Other|||||||0.083||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242_s_at|
1738652|NCT00455533|3200596|Superiority or Other|||||||0.2624||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242_s_at|
1738653|NCT00455533|3200596|Superiority or Other|||||||0.27||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242_s_at|
1738654|NCT00455533|3200596|Superiority or Other|||||||0.8344||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808_at|
1738655|NCT00455533|3200596|Superiority or Other|||||||0.8796||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808_at|
1738656|NCT00455533|3200596|Superiority or Other|||||||0.3727||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808_at|
1738657|NCT00455533|3200596|Superiority or Other|||||||0.2944||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792_s_at|
1738658|NCT00455533|3200596|Superiority or Other|||||||0.163||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792_s_at|
1738659|NCT00455533|3200596|Superiority or Other|||||||0.6783||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792_s_at|
1738660|NCT00455533|3200596|Superiority or Other|||||||0.0032||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040_x_at|
1738661|NCT00455533|3200596|Superiority or Other|||||||0.2053||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040_x_at|
1738662|NCT00455533|3200596|Superiority or Other|||||||0.0033||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040_x_at|
1738663|NCT00455533|3200596|Superiority or Other|||||||0.0192||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318_s_at|
1738664|NCT00455533|3200596|Superiority or Other|||||||0.2688||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318_s_at|
1738665|NCT00455533|3200596|Superiority or Other|||||||0.1058||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318_s_at|
1738666|NCT00455533|3200596|Superiority or Other|||||||0.0692||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942_s_at|
1738667|NCT00455533|3200596|Superiority or Other|||||||0.1388||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942_s_at|
1738668|NCT00455533|3200596|Superiority or Other|||||||0.2245||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942_s_at|
1738669|NCT00455533|3200596|Superiority or Other|||||||0.0576||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317_at|
1738670|NCT00455533|3200596|Superiority or Other|||||||0.0136||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317_at|
1738671|NCT00455533|3200596|Superiority or Other|||||||0.0399||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317_at|
1738672|NCT00455533|3200596|Superiority or Other|||||||0.0284||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315_s_at|
1738673|NCT00455533|3200596|Superiority or Other|||||||0.8705||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315_s_at|
1738674|NCT00455533|3200596|Superiority or Other|||||||0.1185||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315_s_at|
1738675|NCT00455533|3200596|Superiority or Other|||||||0.0146||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720_s_at|
1738676|NCT00455533|3200596|Superiority or Other|||||||0.1999||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720_s_at|
1738677|NCT00455533|3200596|Superiority or Other|||||||0.0151||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720_s_at|
1738678|NCT00455533|3200596|Superiority or Other|||||||0.0283||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719_at|
1738679|NCT00455533|3200596|Superiority or Other|||||||0.0434||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719_at|
1738680|NCT00455533|3200596|Superiority or Other|||||||0.0281||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719_at|
1738681|NCT00455533|3200596|Superiority or Other|||||||0.236||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531_s_at|
1738682|NCT00455533|3200596|Superiority or Other|||||||0.3336||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531_s_at|
1738683|NCT00455533|3200596|Superiority or Other|||||||0.2909||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531_s_at|
1738684|NCT00455533|3200596|Superiority or Other|||||||0.391||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851_x_at|
1738685|NCT00455533|3200596|Superiority or Other|||||||0.7021||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851_x_at|
1738686|NCT00455533|3200596|Superiority or Other|||||||0.9195||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851_x_at|
1738687|NCT00455533|3200596|Superiority or Other|||||||0.6712||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994_s_at|
1738688|NCT00455533|3200596|Superiority or Other|||||||0.1918||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994_s_at|
1738689|NCT00455533|3200596|Superiority or Other|||||||0.6058||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994_s_at|
1738690|NCT00455533|3200596|Superiority or Other|||||||0.5268||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR/RCB1 ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993_at|
1738691|NCT00455533|3200596|Superiority or Other|||||||0.2715||||||P Value 2 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment) and the reduced model: (PCR/RCB1 ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993_at|
1738692|NCT00455533|3200596|Superiority or Other|||||||0.5604||||||P Value 1 is from the likelihood ratio test between the full model: (PCR/RCB1 ~ Biomarker: Treatment: ER) and the reduced model: (PCR/RCB1 ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993_at|
1738693|NCT00455533|3200597|Superiority or Other|||||||0.3346||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684_at|
1738694|NCT00455533|3200597|Superiority or Other|||||||0.172||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684_at|
1738695|NCT00455533|3200597|Superiority or Other|||||||0.5226||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 217684_at|
1738696|NCT00455533|3200597|Superiority or Other|||||||0.2054||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589_at|
1738697|NCT00455533|3200597|Superiority or Other|||||||0.3292||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589_at|
1738698|NCT00455533|3200597|Superiority or Other|||||||0.4473||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TYMS 202589_at|
1738699|NCT00455533|3200597|Superiority or Other|||||||0.5637||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191_at|
1738700|NCT00455533|3200597|Superiority or Other|||||||0.2657||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191_at|
1738701|NCT00455533|3200597|Superiority or Other|||||||0.7324||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB6 209191_at|
1738702|NCT00455533|3200597|Superiority or Other|||||||0.4385||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664_at|
1738703|NCT00455533|3200597|Superiority or Other|||||||0.158||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664_at|
1738704|NCT00455533|3200597|Superiority or Other|||||||0.118||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB4 212664_at|
1738705|NCT00455533|3200597|Superiority or Other|||||||0.1005||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726_x_at|
1738706|NCT00455533|3200597|Superiority or Other|||||||0.3314||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726_x_at|
1738707|NCT00455533|3200597|Superiority or Other|||||||0.476||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 213726_x_at|
1738708|NCT00455533|3200597|Superiority or Other|||||||0.5477||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977_x_at|
1738709|NCT00455533|3200597|Superiority or Other|||||||0.3753||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977_x_at|
1738710|NCT00455533|3200597|Superiority or Other|||||||0.9479||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2C 208977_x_at|
1738711|NCT00455533|3200597|Superiority or Other|||||||0.3636||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023_x_at|
1738712|NCT00455533|3200597|Superiority or Other|||||||0.0266||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023_x_at|
1738862|NCT00453999|3200914|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test|||Headache: change from Baseline at Days 2, 3, 4, 5, 10, 14|
1738713|NCT00455533|3200597|Superiority or Other|||||||0.2158||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2B 214023_x_at|
1738714|NCT00455533|3200597|Superiority or Other|||||||0.1275||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372_x_at|
1738715|NCT00455533|3200597|Superiority or Other|||||||0.2128||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372_x_at|
1738716|NCT00455533|3200597|Superiority or Other|||||||0.3515||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A /// TUBB2B 209372_x_at|
1738717|NCT00455533|3200597|Superiority or Other|||||||0.0699||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141_at|
1738718|NCT00455533|3200597|Superiority or Other|||||||0.929||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141_at|
1738719|NCT00455533|3200597|Superiority or Other|||||||0.382||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB2A 204141_at|
1738720|NCT00455533|3200597|Superiority or Other|||||||0.735||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601_s_at|
1738721|NCT00455533|3200597|Superiority or Other|||||||0.519||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 208601_s_at|
1738722|NCT00455533|3200597|Superiority or Other|||||||0.4943||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB1 (208601_s_at)|
1738723|NCT00455533|3200597|Superiority or Other|||||||0.1117||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026_x_at|
1738724|NCT00455533|3200597|Superiority or Other|||||||0.0868||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026_x_at|
1738725|NCT00455533|3200597|Superiority or Other|||||||0.217||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 209026_x_at|
1738726|NCT00455533|3200597|Superiority or Other|||||||0.2631||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320_at|
1738727|NCT00455533|3200597|Superiority or Other|||||||0.1733||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320_at|
1738728|NCT00455533|3200597|Superiority or Other|||||||0.6406||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 212320_at|
1738729|NCT00455533|3200597|Superiority or Other|||||||0.1058||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714_x_at|
1738730|NCT00455533|3200597|Superiority or Other|||||||0.0769||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714_x_at|
1738731|NCT00455533|3200597|Superiority or Other|||||||0.1689||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||TUBB 211714_x_at|
1738732|NCT00455533|3200597|Superiority or Other|||||||0.0276||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477_s_at|
1738733|NCT00455533|3200597|Superiority or Other|||||||0.2751||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477_s_at|
1738734|NCT00455533|3200597|Superiority or Other|||||||0.107||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201477_s_at|
1738735|NCT00455533|3200597|Superiority or Other|||||||0.1715||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476_s_at|
1738863|NCT00453999|3200914|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test|||Fatigue: change from Baseline at Days 2, 3, 4, 5, 10, 14|
1738736|NCT00455533|3200597|Superiority or Other|||||||0.1025||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476_s_at|
1738737|NCT00455533|3200597|Superiority or Other|||||||0.3323||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||RRM1 201476_s_at|
1738738|NCT00455533|3200597|Superiority or Other|||||||0.5276||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733_at|
1738739|NCT00455533|3200597|Superiority or Other|||||||0.6191||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733_at|
1738740|NCT00455533|3200597|Superiority or Other|||||||0.4767||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK6 204733_at|
1738741|NCT00455533|3200597|Superiority or Other|||||||0.7069||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242_s_at|
1738742|NCT00455533|3200597|Superiority or Other|||||||0.0952||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242_s_at|
1738743|NCT00455533|3200597|Superiority or Other|||||||0.45||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK5 222242_s_at|
1738744|NCT00455533|3200597|Superiority or Other|||||||0.6017||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808_at|
1738745|NCT00455533|3200597|Superiority or Other|||||||0.7187||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808_at|
1738746|NCT00455533|3200597|Superiority or Other|||||||0.2885||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 215808_at|
1738747|NCT00455533|3200597|Superiority or Other|||||||0.3147||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792_s_at|
1738748|NCT00455533|3200597|Superiority or Other|||||||0.2623||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792_s_at|
1738749|NCT00455533|3200597|Superiority or Other|||||||0.7756||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||KLK10 209792_s_at|
1738750|NCT00455533|3200597|Superiority or Other|||||||0.2369||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040_x_at|
1738751|NCT00455533|3200597|Superiority or Other|||||||0.1407||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040_x_at|
1738752|NCT00455533|3200597|Superiority or Other|||||||0.0782||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 211040_x_at|
1738753|NCT00455533|3200597|Superiority or Other|||||||0.1646||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318_s_at|
1738754|NCT00455533|3200597|Superiority or Other|||||||0.2794||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318_s_at|
1738755|NCT00455533|3200597|Superiority or Other|||||||0.4796||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204318_s_at|
1738756|NCT00455533|3200597|Superiority or Other|||||||0.559||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942_s_at|
1738757|NCT00455533|3200597|Superiority or Other|||||||0.149||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942_s_at|
1738758|NCT00455533|3200597|Superiority or Other|||||||0.4103||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 215942_s_at|
1738864|NCT00453999|3200914|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test|||Aches and Pains: change from Baseline at Days 2, 3, 4, 5, 10, 14|
1738759|NCT00455533|3200597|Superiority or Other|||||||0.3569||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317_at|
1738760|NCT00455533|3200597|Superiority or Other|||||||0.025||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317_at|
1738761|NCT00455533|3200597|Superiority or Other|||||||0.1119||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204317_at|
1738762|NCT00455533|3200597|Superiority or Other|||||||0.4085||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315_s_at|
1738763|NCT00455533|3200597|Superiority or Other|||||||0.8947||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315_s_at|
1738764|NCT00455533|3200597|Superiority or Other|||||||0.8847||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||GTSE1 204315_s_at|
1738765|NCT00455533|3200597|Superiority or Other|||||||0.5327||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720_s_at|
1738766|NCT00455533|3200597|Superiority or Other|||||||0.0942||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720_s_at|
1738767|NCT00455533|3200597|Superiority or Other|||||||0.184||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203720_s_at|
1738768|NCT00455533|3200597|Superiority or Other|||||||0.3612||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719_at|
1738769|NCT00455533|3200597|Superiority or Other|||||||0.0235||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719_at|
1738770|NCT00455533|3200597|Superiority or Other|||||||0.1542||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ERCC1 203719_at|
1738771|NCT00455533|3200597|Superiority or Other|||||||0.7588||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531_s_at|
1738772|NCT00455533|3200597|Superiority or Other|||||||0.5031||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531_s_at|
1738773|NCT00455533|3200597|Superiority or Other|||||||0.8052||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 204531_s_at|
1738774|NCT00455533|3200597|Superiority or Other|||||||0.6907||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851_x_at|
1738775|NCT00455533|3200597|Superiority or Other|||||||0.8874||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851_x_at|
1738776|NCT00455533|3200597|Superiority or Other|||||||0.9751||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||BRCA1 211851_x_at|
1738777|NCT00455533|3200597|Superiority or Other|||||||0.3538||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994_s_at|
1738778|NCT00455533|3200597|Superiority or Other|||||||0.1845||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994_s_at|
1738779|NCT00455533|3200597|Superiority or Other|||||||0.553||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 /// ABCB4 209994_s_at|
1738780|NCT00455533|3200597|Superiority or Other|||||||0.5074||||||P Value 3 is the contrast of the interaction between treatment and biomarker expression within ER Negative subjects from the full model:(PCR ~ Biomarker : Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993_at|
1738781|NCT00455533|3200597|Superiority or Other|||||||0.1629||||||P Value 2 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment) and the reduced model: (PCR ~ Biomarker + Treatment)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 209993_at|
1738865|NCT00453999|3200914|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test|||Cough: change from Baseline at Days 2, 3, 4, 5, 10, 14|
1738782|NCT00455533|3200597|Superiority or Other|||||||0.4115||||||P Value 1 is from the likelihood ratio test between the full model: (PCR ~ Biomarker: Treatment: ER) and the reduced model: (PCR ~ Treatment : ER)|Regression, Logistic|p-value not adjusted for multiple comparison||ABCB1 (209993_at)|
1738783|NCT00455533|3200598|Superiority or Other||difference|-2.5|||||2-Sided|90.0|-11.0|6.0|||||The difference in pCR/RCB-I rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.||
1738784|NCT00455533|3200598|Superiority or Other||Odds Ratio (OR)|0.86||||0.5806|2-Sided|90.0|0.56|1.34|||Cochran-Mantel-Haenszel||||
1738785|NCT00455533|3200598|Superiority or Other|||||||0.6186|||||||Fisher Exact||||
1738786|NCT00455533|3200601|Superiority or Other||difference in pCR|-0.6|||||2-Sided|95.0|-7.9|6.7|||||The difference in pCR rates and the confidence interval computed using the method of DerSimonian and Laird stratified by tumor size at baseline, estrogen receptor status, and clinical response to AC.||
1738787|NCT00455533|3200601|Superiority or Other||Odds Ratio (OR)|0.96||||0.8966|2-Sided|90.0|0.6|1.55|||Cochran-Mantel-Haenszel||||
1738788|NCT00455533|3200601|Superiority or Other|||||||0.8921|||||||Fisher Exact||||
1738789|NCT00455520|3200607|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|0.2|<|0.001||95.0|-1.7|-0.92|||ANCOVA|||Analysis of Covariance Model with factors of treatment, country, prior opioid use, and baseline dose level and start of DB pain score as factors.|
1738790|NCT00455429|3200615|Superiority or Other|||||||0.35|||||||Regression, Logistic||||
1738791|NCT00455429|3200615|Superiority or Other|||||||0.952|||||||Regression, Logistic||||
1738792|NCT00455429|3200615|Superiority or Other|||||||0.484|||||||Regression, Logistic||||
1738793|NCT00455429|3200616|Superiority or Other|||||||0.29|||||||Regression, Logistic||||
1738794|NCT00455429|3200616|Superiority or Other|||||||0.433|||||||Regression, Logistic||||
1738795|NCT00455429|3200616|Superiority or Other|||||||0.206|||||||Regression, Logistic||||
1738796|NCT00455429|3200617|Superiority or Other|||||||0.282|||||||Regression, Logistic||||
1738797|NCT00455429|3200617|Superiority or Other|||||||0.382|||||||Regression, Logistic||||
1738798|NCT00455429|3200617|Superiority or Other|||||||0.566|||||||Regression, Logistic||||
1738799|NCT00455429|3200618|Superiority or Other|||||||0.489|||||||Regression, Logistic||||
1738800|NCT00455429|3200618|Superiority or Other|||||||0.077|||||||Regression, Logistic||||
1738801|NCT00455429|3200618|Superiority or Other|||||||0.097|||||||Regression, Logistic||||
1738802|NCT00455429|3200619|Superiority or Other|||||||0.107|||||||Regression, Logistic||||
1738803|NCT00455429|3200619|Superiority or Other|||||||0.206|||||||Regression, Logistic||||
1738804|NCT00455429|3200619|Superiority or Other|||||||0.429|||||||Regression, Logistic||||
1738805|NCT00455429|3200620|Superiority or Other|||||||0.101|||||||Regression, Logistic||||
1738806|NCT00455429|3200620|Superiority or Other|||||||0.523|||||||Regression, Logistic||||
1738807|NCT00455429|3200620|Superiority or Other|||||||0.631|||||||Regression, Logistic||||
1738808|NCT00455429|3200621|Superiority or Other|||||||0.353|||||||Regression, Logistic||||
1738809|NCT00455429|3200621|Superiority or Other|||||||0.527|||||||Regression, Logistic||||
1738810|NCT00455429|3200621|Superiority or Other|||||||0.333|||||||Regression, Logistic||||
1738811|NCT00455429|3200622|Superiority or Other|||||||0.501|||||||Regression, Logistic||||
1738812|NCT00455429|3200622|Superiority or Other|||||||0.968|||||||Regression, Logistic||||
1738813|NCT00455429|3200622|Superiority or Other|||||||0.363|||||||Regression, Logistic||||
1738814|NCT00455429|3200623|Superiority or Other|||||||0.462|||||||Regression, Logistic||||
1738815|NCT00455429|3200623|Superiority or Other|||||||0.479|||||||Regression, Logistic||||
1738816|NCT00455429|3200623|Superiority or Other|||||||0.46|||||||Regression, Logistic||||
1738817|NCT00455429|3200624|Superiority or Other||LS Mean Difference|14.9|Standard Error of the Mean|7.08||0.096|2-Sided|95.0|-2.0|31.86|||Dunnett-Hsu||||
1738818|NCT00455429|3200624|Superiority or Other||LS Mean Difference|14.2|Standard Error of the Mean|8.07||0.196|2-Sided|95.0|-5.12|33.52|||Dunnett-Hsu||||
1738819|NCT00455429|3200624|Superiority or Other||LS Mean difference|3.7|Standard Error of the Mean|8.15||0.941|2-Sided|95.0|-15.83|23.18|||Dunnett-Hsu||||
1738820|NCT00455429|3200625|Superiority or Other||LS Mean Difference|-1.1|Standard Error of the Mean|2.24||0.919|2-Sided|95.0|-6.49|4.21|||Dunnett-Hsu||||
1738821|NCT00455429|3200625|Superiority or Other||LS Mean Difference|-1.3|Standard Error of the Mean|2.55||0.922|2-Sided|95.0|-7.37|4.82|||Dunnett-Hsu||||
1738822|NCT00455429|3200625|Superiority or Other||LS Mean difference|-3.4|Standard Error of the Mean|2.63||0.427|2-Sided|95.0|-9.7|2.9|||Dunnett-Hsu||||
1738823|NCT00455429|3200626|Superiority or Other|||||||0.656|||||||Cochran-Mantel-Haenszel||||
1738824|NCT00455429|3200626|Superiority or Other|||||||0.822|||||||Cochran-Mantel-Haenszel||||
1738825|NCT00455429|3200626|Superiority or Other|||||||0.6|||||||Cochran-Mantel-Haenszel||||
1738826|NCT00454909|3200720|Superiority||Difference in percentage|13.4|||||2-Sided|95.0|7.9|20.1||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup Y (hSBA-MenY) antibody titers ≥ 1:8 one month after vaccination.|
1738827|NCT00454909|3200720|Superiority||Difference in percentage|14.93|||||2-Sided|95.0|8.24|22.71||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup W-135 (hSBA-MenW -135) antibody titers ≥ 1:8 one month after vaccination.|
1738828|NCT00454909|3200720|Superiority||Difference in percentage|-2.77|||||2-Sided|95.0|-5.08|0.4||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup C (hSBA-MenC) antibody titers ≥ 1:8 one month after vaccination.|
1738829|NCT00454909|3200720|Superiority||Difference in percentage|11.2|||||2-Sided|95.0|3.87|19.18||||||Evaluation of the immunogenicity induced by Nimenrix™ conjugate vaccine as compared to Menactra® vaccine in terms of percentage of subjects with serum bactericidal assay using human complement against N. meningitidis serogroup A (hSBA-MenA) antibody titers ≥ 1:8 one month after vaccination.|
1738830|NCT00454818|3200751|Superiority or Other|||||||0.098||||||The a priori threshold for statistical significance was P < 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided||||
1738831|NCT00454818|3200751|Superiority or Other|||||||0.515||||||The a priori threshold for statistical significance was P < 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided||||
1738832|NCT00454818|3200751|Superiority or Other|||||||0.078||||||The a priori threshold for statistical significance was P < 0.2. There were no adjustments for multiple comparisons.|t-test, 2 sided||||
1738833|NCT00454779|3200764|Superiority or Other|||||||0.666|||||||Log Rank|Stratified by IVRS randomization factors|||
1738834|NCT00454779|3200764|Superiority or Other||Hazard Ratio (HR)|1.103||||0.663|2-Sided|95.0|0.709|1.717|||Regression, Cox|Stratified by IVRS randomization factors|Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone||
1738835|NCT00454779|3200767|Superiority or Other||Odds Ratio (OR)|1.76||||||95.0|0.62|5.26|||||Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates||
1738836|NCT00454779|3200767|Superiority or Other||Mean Difference (Final Values)|7.78|||||2-Sided|95.0|-8.29|23.85|||||With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS||
1738837|NCT00454779|3200768|Superiority or Other||Odds Ratio (OR)|1.37||||||95.0|0.57|3.33|||||Calculated from a logistic regression model with treatment indicator and randomization factors (recorded on the CRF) as covariates||
1738838|NCT00454779|3200768|Superiority or Other||Mean Difference (Final Values)|6.23|||||2-Sided|95.0|-11.67|24.12|||||With Mantel-Haenszel weights within strata defined by randomization factors recorded in the IVRS||
1738839|NCT00454779|3200769|Superiority or Other|||||||0.048|||||||Log Rank|Stratified by IVRS randomization factors|||
1738840|NCT00454779|3200769|Superiority or Other||Hazard Ratio (HR)|0.629||||0.051|2-Sided|95.0|0.395|1.002|||Regression, Cox|Stratified by IVRS randomization factors|Hazard ratio is presented as panitumumab plus chemotherapy:chemotherapy alone.||
1738841|NCT00454584|3200819|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight [<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05.|
1738842|NCT00454584|3200819|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight [<90kg vs. ≥ 90 kg).|||
1738843|NCT00454584|3200820|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight [<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05.|
1738844|NCT00454584|3200820|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight [<90kg vs. ≥ 90 kg).|||
1738845|NCT00454584|3200821|Superiority or Other|||||||0.012||||||To control the overall type I error rate at 0.05 level in the primary endpoint analysis, a step-down test procedure was applied. First, ustekinumab 90 mg and etanercept were compared. Then ustekinumab 45 mg and etanercept would be compared.|Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight [<90kg vs. ≥ 90 kg).||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and etanercept at an overall significant level of 0.05. Sample Size: Assuming the PASI 75 response rates of ustekinumab 90 mg, 45 mg, etanercept are 65%, 64%, and 50% , respectively, with 325 participants each in the ustekinumab 90 mg and etanercept groups, the power to detect a treatment difference is 97%. With 200 participants in the ustekinumab 45 mg group, the complete power to further detect a treatment difference was 87%.|
1738846|NCT00454584|3200821|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|The test was stratified by baseline weight [<90kg vs. ≥ 90 kg).|||
1738847|NCT00454181|3200878|Superiority or Other|||||||0.71|||||||Chi-squared|||"Chi-square analysis of the proportion of subjects rated as improved with resepect to changes from baseline to week 24 in global oral health by the attending investigator."|
1738848|NCT00454181|3200879|Superiority or Other|||||||0.74|||||||Chi-squared|||"Chi-square analysis of the proportion of subjects rated as improved with respect to changes in oral warts from baseline to week 24 by the attending investigator."|
1738849|NCT00454181|3200880|Superiority or Other|||||||0.29|||||||Chi-squared|||"Chi-square analysis of the proportion of subjects in each group reporting change in global oral health from baseline to week 24 as better."|
1738850|NCT00454181|3200881|Superiority or Other|||||||0.5|||||||Chi-squared|||"Chi-square analysis of the proportion of subjects in each group reporting change in oral warts from baseline to week 24 as better."|
1738851|NCT00454181|3200882|Superiority or Other|||||||0.26|||||||Chi-squared|||Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response|
1738852|NCT00454181|3200883|Superiority or Other|||||||0.3|||||||Chi-squared|||Chi-square analysis of the proportion of subjects in each group meeting the definition of positive response.|
1738853|NCT00453999|3200910|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test|||Change from Baseline at 96 hours|
1738854|NCT00453999|3200910|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test|||Change from Baseline at 72 hours|
1738855|NCT00453999|3200910|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test|||Change from Baseline at 48 hours|
1738856|NCT00453999|3200910|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test|||Change from Baseline at 36 hours|
1738857|NCT00453999|3200910|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test|||Change from Baseline at 24 hours|
1738858|NCT00453999|3200910|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test|||Change from Baseline at 12 hours|
1738859|NCT00453999|3200911|Superiority or Other|||||||0.994|||||||Log Rank||||
1738860|NCT00453999|3200913|Superiority or Other|||||||0.276|||||||Log Rank||||
1738861|NCT00453999|3200914|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test|||Feeling Feverish: change from Baseline at Days 2, 3, 4, 5, 10, 14|
1738866|NCT00453999|3200914|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test|||Nasal Congestion: change from Baseline at Days 2, 3, 4, 5, 10, 14|
1738867|NCT00453999|3200914|Superiority or Other||||||>|0.05|||||||Wilcoxon Rank Sum Test|||Sore Throat: change from Baseline at Days 2, 3, 4, 5, 10, 14|
1738868|NCT00453999|3200915|Superiority or Other|||||||0.306|||||||Log Rank|Differences between groups by log-rank statistic stratified by oxygen saturation and duration of illness at randomization, and flu season.|||
1738869|NCT00453921|3200954|Superiority||||||<|0.05||||||a priopr|ANCOVA||||
1738870|NCT00453921|3200954|Other||||||<|0.01|||||||ANCOVA||||
1738871|NCT00453921|3200957|Equivalence|group differences|||||<|0.05|||||||ANCOVA||||
1738872|NCT00453921|3200958|Equivalence|Looking for statistical difference, p < .01, between groups looking at change scores|||||<|0.05|||||||ANOVA||||
1738873|NCT00453921|3200960|Other||||||<|0.04||||||For active therapy/placebo relative to both placebo|Kruskal-Wallis||||
1738874|NCT00453479|3200968|Superiority or Other||Ratio|1.644|Standard Error of the Mean|0.138|||2-Sided|90.0|1.29|2.095|||||SE logs is presented as standard error of mean. Comparison of Ae AM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.||
1738875|NCT00453479|3200968|Superiority or Other||Ratio|2.556|Standard Error of the Mean|0.131|||2-Sided|90.0|2.033|3.213|||||SE logs is presented as standard error of mean. Comparison of Ae AM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.||
1738876|NCT00453479|3200970|Superiority or Other||Ratio|1.028|Standard Error of the Mean|0.2407|||2-Sided|90.0|0.674|1.568|||||SE logs is presented as standard error of mean. Comparison of Cmax PM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.||
1738877|NCT00453479|3200970|Superiority or Other||Ratio|0.979|Standard Error of the Mean|0.2269|||2-Sided|90.0|0.658|1.457|||||SE logs is presented as standard error of mean. Comparison of Cmax PM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.||
1738878|NCT00453479|3200970|Superiority or Other||Ratio|1.19|Standard Error of the Mean|0.2482|||2-Sided|90.0|0.77|1.838|||||SE logs is presented as standard error of mean. Comparison of Cmax AM dose for GSK233705 100 µg twice daily Day 7 versus Day 1.||
1738879|NCT00453479|3200970|Superiority or Other||Ratio|1.408|Standard Error of the Mean|0.234|||2-Sided|90.0|0.934|2.122|||||SE logs is presented as standard error of mean. Comparison of Cmax AM dose for GSK233705 50 µg twice daily Day 7 versus Day 1.||
1738880|NCT00453479|3200971|Superiority or Other||Ratio|1.06|Standard Error of the Mean|0.2057|||2-Sided|90.0|0.739|1.52|||||SE logs is presented as standard error of mean. Comparison of GSK233705 100 µg twice daily Day 7 versus Day 1.||
1738881|NCT00453479|3200971|Superiority or Other||Ratio|1.139|Standard Error of the Mean|0.1939|||2-Sided|90.0|0.811|1.601|||||SE logs is presented as standard error of mean. Comparison of GSK233705 50 µg twice daily Day 7 versus Day 1.||
1738882|NCT00453479|3200975|Superiority or Other||Mean Difference (Net)|1.569|Standard Error of the Mean|2.8291|||2-Sided|95.0|-4.353|7.49|||||Comparison of mean heart rate Day 7.||
1738883|NCT00453479|3200975|Superiority or Other||Mean Difference (Net)|-1.074|Standard Error of the Mean|3.3103|||2-Sided|95.0|-8.003|5.854|||||Comparison of mean heart rate Day 1.||
1738884|NCT00453479|3200975|Superiority or Other||Mean Difference (Net)|4.783|Standard Error of the Mean|2.9409|||2-Sided|95.0|-1.372|10.938|||||Comparison of mean heart rate Day 7.||
1738885|NCT00453479|3200975|Superiority or Other||Mean Difference (Net)|2.734|Standard Error of the Mean|3.441|||2-Sided|95.0|-4.468|9.936|||||Comparison of mean heart rate Day 1.||
1738886|NCT00453479|3200975|Superiority or Other||Mean Difference (Net)|0.988|Standard Error of the Mean|7.8616|||2-Sided|95.0|-15.47|17.443|||||Comparison of maximum heart rate Day 7.||
1738887|NCT00453479|3200975|Superiority or Other||Mean Difference (Net)|-1.272|Standard Error of the Mean|3.239|||2-Sided|95.0|-8.051|5.507|||||Comparison of maximum heart rate Day 1.||
1738888|NCT00453479|3200975|Superiority or Other||Mean Difference (Net)|5.73|Standard Error of the Mean|8.0907|||2-Sided|95.0|-11.2|22.664|||||Comparison of maximum heart rate Day 7.||
1738889|NCT00453479|3200975|Superiority or Other||Mean Difference (Net)|2.233|Standard Error of the Mean|3.3333|||2-Sided|95.0|-4.743|9.21|||||Comparison of maximum heart rate Day 1.||
1738890|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.384|Standard Error of the Mean|0.2766|||2-Sided|95.0|-0.162|0.929|||||Comparison of FVC, Day 7, 24 hour||
1738891|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.284|Standard Error of the Mean|0.3034|||2-Sided|95.0|-0.314|0.882|||||Comparison of FVC, Day 7, 12 hour||
1738892|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.445|Standard Error of the Mean|0.2786|||2-Sided|95.0|-0.104|0.994|||||Comparison of FVC, Day 7, 9 hour||
1738893|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.464|Standard Error of the Mean|0.2705|||2-Sided|95.0|-0.069|0.997|||||Comparison of FVC, Day 7, 4 hour||
1738894|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.459|Standard Error of the Mean|0.2748|||2-Sided|95.0|-0.083|1.0|||||Comparison of FVC, Day 7, 2 hour||
1738895|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.623|Standard Error of the Mean|0.2798|||2-Sided|95.0|0.072|1.175|||||Comparison of FVC, Day 7, 1 hour||
1738896|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.535|Standard Error of the Mean|0.2907|||2-Sided|95.0|-0.038|1.108|||||Comparison of FVC, Day 7, Baseline||
1738897|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.162|Standard Error of the Mean|0.2063|||2-Sided|95.0|-0.245|0.569|||||Comparison of FVC, Day 1, 24 hour||
1738898|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.245|Standard Error of the Mean|0.241|||2-Sided|95.0|-0.23|0.72|||||Comparison of FVC, Day 1, 12 hour||
1738899|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.348|Standard Error of the Mean|0.209|||2-Sided|95.0|-0.064|0.76|||||Comparison of FVC, Day 1, 9 hour||
1738900|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.311|Standard Error of the Mean|0.1981|||2-Sided|95.0|-0.079|0.701|||||Comparison of FVC, Day 1, 4 hour||
1738901|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.321|Standard Error of the Mean|0.2039|||2-Sided|95.0|-0.081|0.723|||||Comparison of FVC, Day 1, 2 hour||
1738902|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.152|Standard Error of the Mean|0.2106|||2-Sided|95.0|-0.263|0.567|||||Comparison of FVC, Day 1, 1 hour||
1738903|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.242|Standard Error of the Mean|0.2665|||2-Sided|95.0|-0.283|0.768|||||Comparison of FVC, Day 7, 24 hour||
1738904|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.367|Standard Error of the Mean|0.2923|||2-Sided|95.0|-0.209|0.943|||||Comparison of FVC, Day 7, 12 hour||
1738905|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.266|Standard Error of the Mean|0.2684|||2-Sided|95.0|-0.263|0.795|||||Comparison of FVC, Day 7, 9 hour||
1738906|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.177|Standard Error of the Mean|0.2606|||2-Sided|95.0|-0.337|0.691|||||Comparison of FVC, Day 7, 4 hour||
1738907|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.021|Standard Error of the Mean|0.2648|||2-Sided|95.0|-0.501|0.543|||||Comparison of FVC, Day 7, 2 hour||
1738908|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.269|Standard Error of the Mean|0.2696|||2-Sided|95.0|-0.263|0.8|||||Comparison of FVC, Day 7, 1 hour||
1738909|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.362|Standard Error of the Mean|0.2801|||2-Sided|95.0|-0.19|0.914|||||Comparison of FVC, Day 7, Baseline||
1738910|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.115|Standard Error of the Mean|0.1988|||2-Sided|95.0|-0.277|0.507|||||Comparison of FVC, Day 1, 24 hour||
1738911|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.115|Standard Error of the Mean|0.2322|||2-Sided|95.0|-0.343|0.572|||||Comparison of FVC, Day 1, 12 hour||
1738912|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.06|Standard Error of the Mean|0.2013|||2-Sided|95.0|-0.337|0.457|||||Comparison of FVC, Day 1, 9 hour||
1738913|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|-0.038|Standard Error of the Mean|0.1908|||2-Sided|95.0|-0.414|0.338|||||Comparison of FVC, Day 1, 4 hour||
1738914|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.131|Standard Error of the Mean|0.1965|||2-Sided|95.0|-0.257|0.518|||||Comparison of FVC, Day 1, 2 hour||
1738915|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.137|Standard Error of the Mean|0.2029|||2-Sided|95.0|-0.263|0.537|||||Comparison of FVC, Day 1, 1 hour||
1738916|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.18|Standard Error of the Mean|0.1601|||2-Sided|95.0|-0.136|0.495|||||Comparison of FEV1, Day 7, 24 hour||
1738917|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.193|Standard Error of the Mean|0.1506|||2-Sided|95.0|-0.104|0.49|||||Comparison of FEV1, Day 7, 12 hour||
1738918|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.28|Standard Error of the Mean|0.1579|||2-Sided|95.0|-0.032|0.591|||||Comparison of FEV1, Day 7, 9 hour||
1738919|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.207|Standard Error of the Mean|0.1309|||2-Sided|95.0|-0.051|0.465|||||Comparison of FEV1, Day 7, 4 hour||
1738920|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.202|Standard Error of the Mean|0.1378|||2-Sided|95.0|-0.069|0.474|||||Comparison of FEV1, Day 7, 2 hour||
1738921|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.296|Standard Error of the Mean|0.1361|||2-Sided|95.0|0.027|0.564|||||Comparison of FEV1, Day 7, 1 hour||
1738922|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.256|Standard Error of the Mean|0.1113|||2-Sided|95.0|0.036|0.475|||||Comparison of FEV1, Day 7, Baseline||
1738923|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.154|Standard Error of the Mean|0.1285|||2-Sided|95.0|-0.099|0.407|||||Comparison of FEV1, Day 1, 24 hour||
1738924|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.172|Standard Error of the Mean|0.1165|||2-Sided|95.0|-0.058|0.402|||||Comparison of FEV1, Day 1, 12 hour||
1738925|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.32|Standard Error of the Mean|0.1258|||2-Sided|95.0|0.072|0.568|||||Comparison of FEV1, Day 1, 9 hour||
1738926|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.266|Standard Error of the Mean|0.0895|||2-Sided|95.0|0.09|0.443|||||Comparison of FEV1, Day 1, 4 hour||
1738927|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.329|Standard Error of the Mean|0.0994|||2-Sided|95.0|0.133|0.525|||||Comparison of FEV1, Day 1, 2 hour||
1738928|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.206|Standard Error of the Mean|0.097|||2-Sided|95.0|0.015|0.397|||||Comparison of FEV1, Day 1, 1 hour||
1738929|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.206|Standard Error of the Mean|0.152|||2-Sided|95.0|-0.093|0.506|||||Comparison of FEV1, Day 7, 24 hour||
1738930|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.22|Standard Error of the Mean|0.143|||2-Sided|95.0|-0.062|0.502|||||Comparison of FEV1, Day 7, 12 hour||
1738931|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.205|Standard Error of the Mean|0.1499|||2-Sided|95.0|-0.09|0.501|||||Comparison of FEV1, Day 7, 9 hour||
1738932|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.173|Standard Error of the Mean|0.1243|||2-Sided|95.0|-0.072|0.418|||||Comparison of FEV1, Day 7, 4 hour||
1738933|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.095|Standard Error of the Mean|0.1309|||2-Sided|95.0|-0.163|0.353|||||Comparison of FEV1, Day 7, 2 hour||
1738934|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.229|Standard Error of the Mean|0.1292|||2-Sided|95.0|-0.026|0.483|||||Comparison of FEV1, Day 7, 1 hour||
1738935|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.236|Standard Error of the Mean|0.1057|||2-Sided|95.0|0.027|0.444|||||Comparison of FEV1, Day 7, Baseline||
1738936|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.163|Standard Error of the Mean|0.122|||2-Sided|95.0|-0.077|0.404|||||Comparison of FEV1, Day 1, 24 hour||
1738937|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.124|Standard Error of the Mean|0.1107|||2-Sided|95.0|-0.094|0.343|||||Comparison of FEV1, Day 1, 12 hour||
1738938|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.15|Standard Error of the Mean|0.1195|||2-Sided|95.0|-0.085|0.386|||||Comparison of FEV1, Day 1, 9 hour||
1738939|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.06|Standard Error of the Mean|0.085|||2-Sided|95.0|-0.107|0.228|||||Comparison of FEV1, Day 1, 4 hour||
1738940|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.171|Standard Error of the Mean|0.0944|||2-Sided|95.0|-0.015|0.357|||||Comparison of FEV1, Day 1, 2 hour||
1738941|NCT00453479|3200980|Superiority or Other||Mean Difference (Net)|0.147|Standard Error of the Mean|0.0921|||2-Sided|95.0|-0.035|0.328|||||Comparison of FEV1, Day 1, 1 hour||
1738942|NCT00453479|3200981|Superiority or Other||Mean Difference (Net)|20.46|Standard Error of the Mean|5.394|||2-Sided|95.0|9.17|31.75|||||Comparison of QTcF Day 7.||
1738943|NCT00453479|3200981|Superiority or Other||Mean Difference (Net)|16.83|Standard Error of the Mean|4.759|||2-Sided|95.0|6.87|26.79|||||Comparison of QTcF Day 1.||
1738944|NCT00453479|3200981|Superiority or Other||Mean Difference (Net)|8.75|Standard Error of the Mean|5.239|||2-Sided|95.0|-2.21|19.72|||||Comparison of QTcF Day 7.||
1738945|NCT00453479|3200981|Superiority or Other||Mean Difference (Net)|8.32|Standard Error of the Mean|4.622|||2-Sided|95.0|-1.35|18.0|||||Comparison of QTcF Day 1.||
1738946|NCT00453479|3200981|Superiority or Other||Mean Difference (Net)|15.28|Standard Error of the Mean|6.157|||2-Sided|95.0|2.39|28.17|||||Comparison of QTcB Day 7.||
1738947|NCT00453479|3200981|Superiority or Other||Mean Difference (Net)|11.47|Standard Error of the Mean|5.49|||2-Sided|95.0|-0.02|22.96|||||Comparison of QTcB Day 1.||
1738948|NCT00453479|3200981|Superiority or Other||Mean Difference (Net)|8.39|Standard Error of the Mean|5.902|||2-Sided|95.0|-3.97|20.74|||||Comparison of QTcB Day 7.||
1738949|NCT00453479|3200981|Superiority or Other||Mean Difference (Net)|9.55|Standard Error of the Mean|5.262|||2-Sided|95.0|-1.46|20.57|||||Comparison of QTcB Day 1.||
1738950|NCT00453479|3200982|Superiority or Other||Mean Difference (Net)|22.32|Standard Error of the Mean|5.454|||2-Sided|95.0|10.9|33.73|||||Comparison of QTcF Day 7.||
1738951|NCT00453479|3200982|Superiority or Other||Mean Difference (Net)|17.66|Standard Error of the Mean|9.171|||2-Sided|95.0|-1.53|36.85|||||Comparison of QTcF Day 1.||
1738952|NCT00453479|3200982|Superiority or Other||Mean Difference (Net)|12.29|Standard Error of the Mean|5.298|||2-Sided|95.0|1.2|23.38|||||Comparison of QTcF Day 7.||
1738953|NCT00453479|3200982|Superiority or Other||Mean Difference (Net)|2.13|Standard Error of the Mean|8.908|||2-Sided|95.0|-16.51|20.78|||||Comparison of QTcF Day 1.||
1738954|NCT00453479|3200982|Superiority or Other||Mean Difference (Net)|16.5|Standard Error of the Mean|7.052|||2-Sided|95.0|1.74|31.26|||||Comparison of QTcB Day 7.||
1738955|NCT00453479|3200982|Superiority or Other||Mean Difference (Net)|10.57|Standard Error of the Mean|8.51|||2-Sided|95.0|-7.24|28.38|||||Comparison of QTcB Day 1.||
1738956|NCT00453479|3200982|Superiority or Other||Mean Difference (Net)|9.02|Standard Error of the Mean|6.76|||2-Sided|95.0|-5.13|23.17|||||Comparison of QTcB Day 7.||
1738957|NCT00453479|3200982|Superiority or Other||Mean Difference (Net)|4.42|Standard Error of the Mean|8.157|||2-Sided|95.0|-12.66|21.49|||||Comparison of QTcB Day 1.||
1738958|NCT00453479|3200984|Superiority or Other||Mean Difference (Net)|-3.84|Standard Error of the Mean|2.989|||2-Sided|95.0|-10.1|2.41|||||Comparison at Day 7.||
1738959|NCT00453479|3200984|Superiority or Other||Mean Difference (Net)|-2.67|Standard Error of the Mean|2.869|||2-Sided|95.0|-8.67|3.34|||||Comparison at Day 1.||
1738960|NCT00453479|3200984|Superiority or Other||Mean Difference (Net)|2.39|Standard Error of the Mean|2.813|||2-Sided|95.0|-3.5|8.28|||||Comparison at Day 7.||
1738961|NCT00453479|3200984|Superiority or Other||Mean Difference (Net)|0.14|Standard Error of the Mean|2.7|||2-Sided|95.0|-5.52|5.79|||||Comparison at Day 1.||
1738962|NCT00453479|3200985|Superiority or Other||Mean Difference (Net)|-9.39|Standard Error of the Mean|2.224|||2-Sided|95.0|-14.04|-4.73|||||Comparison of DBP Day 7.||
1738963|NCT00453479|3200985|Superiority or Other||Mean Difference (Net)|-1.75|Standard Error of the Mean|1.916|||2-Sided|95.0|-5.76|2.26|||||Comparison of DBP Day 1.||
1738964|NCT00453479|3200985|Superiority or Other||Mean Difference (Net)|-3.89|Standard Error of the Mean|2.116|||2-Sided|95.0|-8.32|0.54|||||Comparison of DBP Day 7.||
1738965|NCT00453479|3200985|Superiority or Other||Mean Difference (Net)|-0.28|Standard Error of the Mean|1.822|||2-Sided|95.0|-4.09|3.54|||||Comparison of DBP Day 1.||
1738966|NCT00453479|3200985|Superiority or Other||Mean Difference (Net)|-3.5|Standard Error of the Mean|4.005|||2-Sided|95.0|-11.88|4.89|||||Comparison of SBP Day 7.||
1738967|NCT00453479|3200985|Superiority or Other||Mean Difference (Net)|3.01|Standard Error of the Mean|4.718|||2-Sided|95.0|-6.87|12.88|||||Comparison of SBP Day 1.||
1738968|NCT00453479|3200985|Superiority or Other||Mean Difference (Net)|-1.88|Standard Error of the Mean|3.913|||2-Sided|95.0|-10.07|6.31|||||Comparison of SBP Day 7.||
1738969|NCT00453479|3200985|Superiority or Other||Mean Difference (Net)|-2.78|Standard Error of the Mean|4.611|||2-Sided|95.0|-12.43|6.87|||||Comparison of SBP Day 1.||
1738970|NCT00453479|3200986|Superiority or Other||Mean Difference (Net)|-5.44|Standard Error of the Mean|4.021|||2-Sided|95.0|-13.86|2.97|||||Comparison at Day 7.||
1738971|NCT00453479|3200986|Superiority or Other||Mean Difference (Net)|0.16|Standard Error of the Mean|3.979|||2-Sided|95.0|-8.17|8.48|||||Comparison at Day 1.||
1738972|NCT00453479|3200986|Superiority or Other||Mean Difference (Net)|2.62|Standard Error of the Mean|3.785|||2-Sided|95.0|-5.3|10.54|||||Comparison at Day 7.||
1738973|NCT00453479|3200986|Superiority or Other||Mean Difference (Net)|2.26|Standard Error of the Mean|3.745|||2-Sided|95.0|-5.58|10.1|||||Comparison at Day 1.||
1738974|NCT00453479|3200987|Superiority or Other||Mean Difference (Net)|-10.81|Standard Error of the Mean|2.504|||2-Sided|95.0|-16.05|-5.57|||||Comparison of DBP Day 7.||
1738975|NCT00453479|3200987|Superiority or Other||Mean Difference (Net)|0.98|Standard Error of the Mean|2.248|||2-Sided|95.0|-3.73|5.68|||||Comparison of DBP Day 1.||
1738976|NCT00453479|3200987|Superiority or Other||Mean Difference (Net)|-6.64|Standard Error of the Mean|2.382|||2-Sided|95.0|-11.62|-1.65|||||Comparison of DBP Day 7.||
1738977|NCT00453479|3200987|Superiority or Other||Mean Difference (Net)|0.58|Standard Error of the Mean|2.138|||2-Sided|95.0|-3.89|5.06|||||Comparison of DBP Day 1.||
1738978|NCT00453479|3200987|Superiority or Other||Mean Difference (Net)|-4.76|Standard Error of the Mean|4.314|||2-Sided|95.0|-13.79|4.27|||||Comparison of SBP Day 7.||
1738979|NCT00453479|3200987|Superiority or Other||Mean Difference (Net)|6.21|Standard Error of the Mean|5.727|||2-Sided|95.0|-5.78|18.19|||||Comparison of SBP Day 1.||
1738980|NCT00453479|3200987|Superiority or Other||Mean Difference (Net)|-4.1|Standard Error of the Mean|4.215|||2-Sided|95.0|-12.92|4.72|||||Comparison of SBP Day 7.||
1738981|NCT00453479|3200987|Superiority or Other||Mean Difference (Net)|-0.97|Standard Error of the Mean|5.596|||2-Sided|95.0|-12.68|10.75|||||Comparison of SBP Day 1.||
1739008|NCT00452790|3201055|Superiority or Other|||||||0.487|||||||Fisher Exact|||Difference in incidence rates of increased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1738982|NCT00453362|3200996|Superiority or Other||Hazard Ratio (HR)|0.35||||0.327|2-Sided|95.0|0.04|3.16||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Progressive Disease.|The null hypothesis is that there is no difference in OS between FLT Responders and FLT Progressive Disease. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Progressive Disease.|
1738983|NCT00453362|3200997|Superiority or Other||Hazard Ratio (HR)|0.38||||0.163|2-Sided|95.0|0.09|1.57||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Non-Responders.|The null hypothesis is that there is no difference in OS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Non-Responders.|
1738984|NCT00453362|3200998|Superiority or Other||Hazard Ratio (HR)|0.67||||0.618|2-Sided|95.0|0.14|3.21||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Progressive Disease.|The null hypothesis is that there is no difference in Overall Survival between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have prolonged OS compared with FDG Progressive Disease.|
1738985|NCT00453362|3201001|Superiority or Other||Hazard Ratio (HR)|0.36||||0.073|2-Sided|95.0|0.11|1.16||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Non-Responders.|The null hypothesis is that there is no difference in OS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG responders would have prolonged OS compared with FDG Non-Responders.|
1738986|NCT00453362|3201002|Superiority or Other|||||||0.049||||||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank|||The null hypothesis is that there is no difference between FLT Responders and FLT Progressive Disease. Alternative hypothesis is that FLT responders would have prolonged PFS compared to FLT Progressive Disease.|
1738987|NCT00453362|3201003|Superiority or Other||Hazard Ratio (HR)|0.17||||0.008|2-Sided|95.0|0.04|0.73||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FLT Non-Responders.|The null hypothesis is that there is no difference in PFS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged PFS compared with FLT Non-Responders.|
1738988|NCT00453362|3201005|Superiority or Other||Hazard Ratio (HR)|0.3||||0.076|2-Sided|95.0|0.06|1.42||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Progressive Disease.|The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have a prolonged PFS compared to FDG Progressive Disease.|
1738989|NCT00453362|3201007|Superiority or Other||Hazard Ratio (HR)|0.31||||0.017|2-Sided|95.0|0.11|0.87||This comparison is for hypothesis generation, rather than hypothesis testing. Thus the p-value is not adjusted for multiple comparisons, and the interpretation of p-value should be with caution.|Log Rank||The hazard ratio was estimated using a Cox Proportional Hazard Model. The hazard ratio is relative to FDG Non-Responders.|The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG Responders would have prolonged PFS compared with FDG Non-Responders.|
1738990|NCT00453349|3201009|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|3.7||||||95.0|-30.5|11.9|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)|
1738991|NCT00453349|3201010|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-7.9||||||95.0|-24.9|15.9|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)|
1738992|NCT00453349|3201011|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-0.1||||||95.0|-8.1|7.5|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)|
1739072|NCT00452790|3201062|Superiority or Other|||||||||||||||||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1738993|NCT00453349|3201012|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-2.5||||||95.0|-8.6|4.9|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)|
1738994|NCT00453349|3201013|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|4.3||||||95.0|-19.4|17.6|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)|
1738995|NCT00453349|3201014|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|5.4||||||95.0|-12.7|20.3|||||Mean difference denotes the difference of eradication rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)|
1738996|NCT00453349|3201015|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-0.1||||||95.0|-8.1|7.5|||||Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)|
1738997|NCT00453349|3201016|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-3.2||||||95.0|-7.4|0.8|||||Mean difference denotes the difference of clinical improvement rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)|
1738998|NCT00453349|3201017|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variables.|Mean Difference (Final Values)|-1.9||||||95.0|-9.9|6.0|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)|
1738999|NCT00453349|3201018|Non-Inferiority or Equivalence|The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: ”Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference...”, pg.1447-1454 [1990]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 87% in the per protocol population|Mean Difference (Final Values)|-3.2||||||95.0|-10.7|4.9|||||Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990)|
1739000|NCT00453154|3201041|Non-Inferiority or Equivalence (legacy)|Using a 1-sided significance level of 0.15, the study has approximately 89% power to reject the null hypothesis|Hazard Ratio (HR)|1.62||||0.02|2-Sided|70.0|1.27|2.08||All randomization was done using a permuted-block scheme with a block size of 6, stratified by combination chemotherapy (cisplatin vs carboplatin) and number of combination chemotherapy cycles (< 6 vs 6 cycles)|Log Rank||||
1739001|NCT00453063|3201049|Superiority or Other|||||||0.356|||||||ANCOVA||||
1739002|NCT00453063|3201050|Superiority or Other|||||||0.063|||||||ANCOVA||||
1739003|NCT00453063|3201051|Superiority or Other|||||||0.004|||||||ANCOVA||||
1739004|NCT00453063|3201052|Superiority or Other|||||||0.304|||||||ANCOVA||||
1739005|NCT00453063|3201053|Superiority or Other|||||||0.001|||||||ANCOVA||||
1739006|NCT00452790|3201055|Superiority or Other|||||||0.753|||||||Fisher Exact|||Difference in incidence rates of any systemic event fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739007|NCT00452790|3201055|Superiority or Other|||||||0.388|||||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739089|NCT00452530|3201087|Superiority or Other||Adjusted difference of event rates|-1.24||||0.0881|2-Sided|95.0|-2.66|0.18|||Mantel Haenszel||Apixaban-enoxaparin|Major or CRNM|
1739009|NCT00452790|3201055|Superiority or Other|||||||0.511|||||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739010|NCT00452790|3201055|Superiority or Other|||||||0.401|||||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739011|NCT00452790|3201055|Superiority or Other|||||||||||||||||Difference in incidence rates of fever >40 degrees C within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739012|NCT00452790|3201055|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Difference in incidence rates of fever >39 but <= 40 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739013|NCT00452790|3201055|Superiority or Other||||||>|0.815|||||||Fisher Exact|||Difference in incidence rates of fever >= 38 but <= 39 degrees within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739014|NCT00452790|3201056|Superiority or Other|||||||0.422|||||||Fisher Exact|||Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739015|NCT00452790|3201056|Superiority or Other|||||||0.265|||||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739016|NCT00452790|3201056|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Difference in incidence rates of increased sleep within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739017|NCT00452790|3201056|Superiority or Other||||||>|0.605|||||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739018|NCT00452790|3201056|Superiority or Other||||||>|0.84|||||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739019|NCT00452790|3201056|Superiority or Other||||||>|0.489|||||||Fisher Exact|||Difference in incidence rates of fever >40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739020|NCT00452790|3201056|Superiority or Other||||||>|||||||||||Difference in incidence rates of fever >39 but <= 40 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739021|NCT00452790|3201056|Superiority or Other||||||>|0.085|||||||Fisher Exact|||Difference in incidence rates of fever >= 38 but <= 39 degrees C within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739022|NCT00452790|3201057|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Difference in incidence rates of Any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739023|NCT00452790|3201057|Superiority or Other||||||>|0.034|||||||Fisher Exact|||Difference in incidence rates of Decreased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739024|NCT00452790|3201057|Superiority or Other||||||>|0.098|||||||Fisher Exact|||Difference in incidence rates of Increased sleep within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739025|NCT00452790|3201057|Superiority or Other||||||>|0.856|||||||Fisher Exact|||Difference in incidence rates of Irritability within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739026|NCT00452790|3201057|Superiority or Other||||||>|0.736|||||||Fisher Exact|||Difference in incidence rates of Decreased appetite within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739027|NCT00452790|3201057|Superiority or Other||||||>|0.488|||||||Fisher Exact|||Difference in incidence rates of fever >40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739028|NCT00452790|3201057|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Difference in incidence rates of fever >39 but <= 40 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739029|NCT00452790|3201057|Superiority or Other||||||>|0.111|||||||Fisher Exact|||Difference in incidence rates of fever >= 38 but <= 39 degrees C within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739030|NCT00452790|3201058|Superiority or Other|||||||0.085|||||||Fisher Exact|||Difference in incidence rates of any systemic event (fever, decrease in appetite, irritability, increased or decreased sleep) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739031|NCT00452790|3201058|Superiority or Other|||||||0.939|||||||Fisher Exact|||Difference in incidence rates of decreased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739032|NCT00452790|3201058|Superiority or Other|||||||0.307|||||||Fisher Exact|||Difference in incidence rates of Increased sleep within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739033|NCT00452790|3201058|Superiority or Other|||||||0.282|||||||Fisher Exact|||Difference in incidence rates of irritability within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739034|NCT00452790|3201058|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Difference in incidence rates of decreased appetite within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739035|NCT00452790|3201058|Superiority or Other||||||>|0.624|||||||Fisher Exact|||Difference in incidence rates of fever >40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739036|NCT00452790|3201058|Superiority or Other||||||>|0.375|||||||Fisher Exact|||Difference in incidence rates of fever >39 but <=40 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739037|NCT00452790|3201058|Superiority or Other||||||>|0.625|||||||Fisher Exact|||Difference in incidence rates of fever >=38 but <=39 degrees C within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739038|NCT00452790|3201059|Superiority or Other|||||||0.446|||||||Fisher Exact|||Difference in incidence rates of any local reaction (tenderness, induration, erythema) within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739039|NCT00452790|3201059|Superiority or Other|||||||||||||||||Difference in incidence rates of erythema-severe within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739040|NCT00452790|3201059|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739041|NCT00452790|3201059|Superiority or Other||||||>|0.739|||||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739042|NCT00452790|3201059|Superiority or Other||||||>|0.88|||||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739043|NCT00452790|3201059|Superiority or Other||||||>|||||||||||Difference in incidence rates of induration-severe within 4 days of the toddler dose (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739044|NCT00452790|3201059|Superiority or Other||||||>|0.509|||||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739045|NCT00452790|3201059|Superiority or Other||||||>|0.881|||||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739046|NCT00452790|3201059|Superiority or Other||||||>|0.681|||||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739047|NCT00452790|3201059|Superiority or Other||||||>|0.772|||||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the toddler dose, dose 4(12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739048|NCT00452790|3201059|Superiority or Other||||||>|0.908|||||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the toddler dose, dose 4 (12 months of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739049|NCT00452790|3201060|Superiority or Other|||||||0.842|||||||Fisher Exact|||Difference in incidence rates of any Local Reaction (tenderness, induration, erythema) within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739050|NCT00452790|3201060|Superiority or Other|||||||||||||||||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739566|NCT00446992|3201800|Superiority or Other||||||=|0|||||||Univariate linear regression|||Baseline compared to Week 16|
1739051|NCT00452790|3201060|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739052|NCT00452790|3201060|Superiority or Other||||||>|0.735|||||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739053|NCT00452790|3201060|Superiority or Other||||||>|0.867|||||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739054|NCT00452790|3201060|Superiority or Other||||||>|||||||||||Difference in incidence rates of induration-severe within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739055|NCT00452790|3201060|Superiority or Other||||||>|0.771|||||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739056|NCT00452790|3201060|Superiority or Other||||||>|0.305|||||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739057|NCT00452790|3201060|Superiority or Other||||||>|0.404|||||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739058|NCT00452790|3201060|Superiority or Other||||||>|0.906|||||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739059|NCT00452790|3201060|Superiority or Other||||||>|0.918|||||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 3 (14 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739060|NCT00452790|3201061|Superiority or Other|||||||0.738|||||||Fisher Exact|||Difference in incidence rates of any Local reaction (tenderness, induration, erythema) within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739061|NCT00452790|3201061|Superiority or Other|||||||||||||||||Difference in incidence rates of erythema-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739062|NCT00452790|3201061|Superiority or Other|||||||0.382|||||||Fisher Exact|||Difference in incidence rates of erythema-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739063|NCT00452790|3201061|Superiority or Other|||||||0.399|||||||Fisher Exact|||Difference in incidence rates of Erythema-Mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739064|NCT00452790|3201061|Superiority or Other|||||||0.203|||||||Fisher Exact|||Difference in incidence rates of erythema-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739065|NCT00452790|3201061|Superiority or Other|||||||||||||||||Difference in incidence rates of induration-severe within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739066|NCT00452790|3201061|Superiority or Other|||||||0.683|||||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739067|NCT00452790|3201061|Superiority or Other|||||||0.909|||||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739068|NCT00452790|3201061|Superiority or Other|||||||0.596|||||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739069|NCT00452790|3201061|Superiority or Other|||||||0.776|||||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739070|NCT00452790|3201061|Superiority or Other|||||||0.933|||||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 2 (10 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739071|NCT00452790|3201062|Superiority or Other|||||||0.69|||||||Fisher Exact|||Difference in incidence rates of any local reaction (tenderness, induration and erythema) within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739090|NCT00452530|3201087|Superiority or Other||Adjusted difference of event rates|-0.91||||0.1668|2-Sided|95.0|-2.2|0.38|||Mantel Haenszel||Apixaban-enoxaparin|CRNM|
1739073|NCT00452790|3201062|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Difference in incidence rates of Erythema-Moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739074|NCT00452790|3201062|Superiority or Other||||||>|0.904|||||||Fisher Exact|||Difference in incidence rates of erythema-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739075|NCT00452790|3201062|Superiority or Other||||||>|0.819|||||||Fisher Exact|||Difference in incidence rates of Erythema-Any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739076|NCT00452790|3201062|Superiority or Other||||||>|||||||||||Difference in incidence rates of Induration-Severe within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739077|NCT00452790|3201062|Superiority or Other||||||>|0.729|||||||Fisher Exact|||Difference in incidence rates of induration-moderate within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739078|NCT00452790|3201062|Superiority or Other||||||>|0.99|||||||Fisher Exact|||Difference in incidence rates of induration-mild within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739079|NCT00452790|3201062|Superiority or Other||||||>|0.782|||||||Fisher Exact|||Difference in incidence rates of induration-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739080|NCT00452790|3201062|Superiority or Other||||||>|0.698|||||||Fisher Exact|||Difference in incidence rates of tenderness-significant within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739081|NCT00452790|3201062|Superiority or Other||||||>|0.483|||||||Fisher Exact|||Difference in incidence rates of tenderness-any within 4 days of the infant series dose 1 (6 weeks of age) reported in the 13vPnC group relative to the incidence rates in the 7vPnC group. No hypothesis testing was performed. The analysis is descriptive.|
1739082|NCT00452699|3201071|Superiority or Other||Least Squares Mean Difference|0.11|||<|0.001||95.0|0.07|0.15|||ANCOVA||||
1739083|NCT00452543|3201078|Non-Inferiority or Equivalence|"This was a test of non-inferiority between the effects of acamprosate vs. placebo. Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.~Power analysis is discussed above."|||||<|0.05||||||This p<0.05 was set a priori.|Wilcoxon (Mann-Whitney)|||"Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per drinking day.~Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups."|
1739084|NCT00452543|3201079|Non-Inferiority or Equivalence|This was a test of non-inferiority between the effects of acamprosate vs. placebo.|||||<|0.05||||||This p <0.05 was set a priori.|Wilcoxon (Mann-Whitney)|||Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinks consumed per week.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.|
1739085|NCT00452543|3201080|Non-Inferiority or Equivalence|This was a test of non-inferiority between the effects of acamprosate vs. placebo. Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups. Results would be used to estimate effect size to set the stage for an adequately powered larger study in the future.|||||<|0.05||||||Threshold for significance was set a priori at p<0.05.|Wilcoxon (Mann-Whitney)|||Statistical analyses evaluated the null hypothesis that there would be no difference in the effect of acamprosate vs. placebo on total drinking days.Power analysis was originally based on ITT analysis with 40 subjects, and assumed 30% difference in alcohol consumption (50% vs. 20% reduction in the acamprosate and placebo groups, respectively). With alpha of 0.05, we estimated 74% power to detect a difference between the two groups.|
1739086|NCT00452530|3201086|Superiority or Other||Risk Difference (RD)|-9.27|||<|0.0001||95.0|-12.74|-5.79||P-value is statistically significant at the 1-sided 0.025 level|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If NI on primary endpoint was demonstrated, superiority for the endpoint was then tested at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the key secondary endpoint at 1-sided α=0.025 level.|
1739087|NCT00452530|3201086|Superiority or Other||Risk Ratio (RR)|0.62|||<|0.0001|2-Sided|95.0|0.51|0.74||P-value was statistically significant at the 1-sided 0.025 level|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If NI on primary endpoint was demonstrated, superiority for the endpoint was then tested at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the key secondary endpoint at 1-sided α=0.025 level.|
1739088|NCT00452530|3201087|Superiority or Other||Adjusted difference of event rates|-1.39||||0.1412|2-Sided|95.0|-3.29|0.51|||Mantel Haenszel||Apixaban-enoxaparin|Any bleeding|
1739567|NCT00446992|3201801|Superiority or Other||||||=|0|||||||Univariate linear regression|||Baseline compared to Week 16|
1739091|NCT00452530|3201087|Superiority or Other||Adjusted difference of event rates|-0.33||||0.3014|2-Sided|95.0|-0.95|0.29|||Mantel Haenszel||Apixaban-enoxaparin|Major bleeding|
1739092|NCT00452530|3201088|Superiority or Other||Risk Difference (RD)|-1.04||||||95.0|-2.03|-0.05||||||Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the secondary endpoint at a 1-sided α=0.025 level. If NI of the secondary endpoint was demonstrated, superiority was then tested at the 1-sided α=0.025 level.|
1739093|NCT00452530|3201088|Superiority or Other||Risk Ratio (RR)|0.5||||0.0003||||||1-sided P-value|Yanagawa, Tango, and Hiejima test||Apixaban-enoxaparin|Sequential testing was used to control for overall type-I error and to compare the effect of apixaban with that of enoxaparin. Noninferiority (NI) of apixaban compared with enoxaparin for primary endpoint was tested first at 1-sided α=0.025 level. If superiority was demonstrated on the primary endpoint, NI was then tested on the secondary endpoint at a 1-sided α=0.025 level. If NI of the secondary endpoint was demonstrated, superiority was then tested at the 1-sided α=0.025 level.|
1739094|NCT00452426|3201094|Superiority or Other||||||<|0.001|||||||ANOVA||||
1739095|NCT00452426|3201095|Superiority or Other|||||||0.007|||||||ANOVA||||
1739096|NCT00452426|3201097|Superiority or Other|||||||0.028|||||||ANOVA||||
1739097|NCT00452400|3201108|Superiority or Other||Mean Difference (Final Values)|-0.414|Standard Error of the Mean|0.369||0.2626|2-Sided|95.0|-1.138|0.311|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739098|NCT00452400|3201108|Superiority or Other||Mean Difference (Final Values)|-0.964|Standard Error of the Mean|0.359||0.0076|2-Sided|95.0|-1.671|-0.258|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739099|NCT00452400|3201108|Superiority or Other||Mean Difference (Final Values)|0.138|Standard Error of the Mean|0.367||0.7065|2-Sided|95.0|-0.583|0.859|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739100|NCT00452400|3201108|Superiority or Other||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.364||0.1541|2-Sided|95.0|-1.237|0.196|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739101|NCT00452400|3201109|Superiority or Other||Mean Difference (Final Values)|25.408|Standard Error of the Mean|6.403|<|0.0001|2-Sided|95.0|12.814|38.002|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739102|NCT00452400|3201109|Superiority or Other||Mean Difference (Final Values)|38.232|Standard Error of the Mean|6.192|<|0.0001|2-Sided|95.0|26.054|50.409|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739103|NCT00452400|3201109|Superiority or Other||Mean Difference (Final Values)|22.333|Standard Error of the Mean|6.36|<|0.0005|2-Sided|95.0|9.824|34.842|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739104|NCT00452400|3201109|Superiority or Other||Mean Difference (Final Values)|10.446|Standard Error of the Mean|6.283|<|0.0973|2-Sided|95.0|-1.911|22.803|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739105|NCT00452400|3201110|Superiority or Other||Mean Difference (Final Values)|23.063|Standard Error of the Mean|5.99||0.0001|2-Sided|95.0|11.282|34.845|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739106|NCT00452400|3201110|Superiority or Other||Mean Difference (Final Values)|38.077|Standard Error of the Mean|5.832|<|0.0001|2-Sided|95.0|26.607|49.546|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739107|NCT00452400|3201110|Superiority or Other||Mean Difference (Final Values)|21.285|Standard Error of the Mean|5.951|<|0.0004|2-Sided|95.0|9.581|32.99|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739108|NCT00452400|3201110|Superiority or Other||Mean Difference (Final Values)|13.705|Standard Error of the Mean|5.916|<|0.0211|2-Sided|95.0|2.07|25.34|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739109|NCT00452400|3201111|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.043||0.0376||95.0|0.005|0.174|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739110|NCT00452400|3201111|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.043||0.0013||95.0|0.055|0.225|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739111|NCT00452400|3201111|Superiority or Other||Mean Difference (Final Values)|0.129|Standard Error of the Mean|0.042||0.0024||95.0|0.046|0.212|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739112|NCT00452400|3201111|Superiority or Other||Mean Difference (Final Values)|0.053|Standard Error of the Mean|0.043||0.2158||95.0|-0.031|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739113|NCT00452400|3201112|Superiority or Other||Mean Difference (Final Values)|0.092|Standard Error of the Mean|0.043||0.0333||95.0|0.007|0.177|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739114|NCT00452400|3201112|Superiority or Other||Mean Difference (Final Values)|0.099|Standard Error of the Mean|0.043||0.023||95.0|0.014|0.184|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739115|NCT00452400|3201112|Superiority or Other||Mean Difference (Final Values)|0.129|Standard Error of the Mean|0.042||0.0024||95.0|0.046|0.212|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739116|NCT00452400|3201112|Superiority or Other||Mean Difference (Final Values)|0.053|Standard Error of the Mean|0.043||0.215||95.0|-0.031|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739117|NCT00452400|3201113|Superiority or Other||Mean Difference (Final Values)|0.137|Standard Error of the Mean|0.039||0.0006||95.0|0.059|0.214|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739118|NCT00452400|3201113|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.04||0.0002||95.0|0.072|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739119|NCT00452400|3201113|Superiority or Other||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.039|<|0.0001||95.0|0.098|0.25|||ANCOVA||Olo 2 mcg qd minus Placebo||
1739120|NCT00452400|3201113|Superiority or Other||Mean Difference (Final Values)|0.085|Standard Error of the Mean|0.039|<|0.0309||95.0|0.008|0.162|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739121|NCT00452400|3201114|Superiority or Other||Mean Difference (Final Values)|0.152|Standard Error of the Mean|0.039||0.0001||95.0|0.076|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739122|NCT00452400|3201114|Superiority or Other||Mean Difference (Final Values)|0.176|Standard Error of the Mean|0.039|<|0.0001||95.0|0.099|0.253|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739123|NCT00452400|3201114|Superiority or Other||Mean Difference (Final Values)|0.147|Standard Error of the Mean|0.038|<|0.0001||95.0|0.072|0.222|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739124|NCT00452400|3201114|Superiority or Other||Mean Difference (Final Values)|0.045|Standard Error of the Mean|0.039|<|0.2392||95.0|-0.03|0.121|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739125|NCT00452400|3201115|Superiority or Other||Mean Difference (Final Values)|0.201|Standard Error of the Mean|0.033|<|0.0001||95.0|0.137|0.265|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739126|NCT00452400|3201115|Superiority or Other||Mean Difference (Final Values)|0.203|Standard Error of the Mean|0.032|<|0.0001||95.0|0.14|0.266|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739127|NCT00452400|3201115|Superiority or Other||Mean Difference (Final Values)|0.189|Standard Error of the Mean|0.032|<|0.0001||95.0|0.125|0.252|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739128|NCT00452400|3201115|Superiority or Other||Mean Difference (Final Values)|0.165|Standard Error of the Mean|0.032|<|0.0001||95.0|0.101|0.228|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739129|NCT00452400|3201116|Superiority or Other||Mean Difference (Final Values)|0.259|Standard Error of the Mean|0.032|<|0.0001||95.0|0.197|0.322|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739130|NCT00452400|3201116|Superiority or Other||Mean Difference (Final Values)|0.233|Standard Error of the Mean|0.031|<|0.0001||95.0|0.172|0.295|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739131|NCT00452400|3201116|Superiority or Other||Mean Difference (Final Values)|0.231|Standard Error of the Mean|0.032|<|0.0001||95.0|0.169|0.294|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739132|NCT00452400|3201116|Superiority or Other||Mean Difference (Final Values)|0.202|Standard Error of the Mean|0.032|<|0.0001||95.0|0.14|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739133|NCT00452400|3201117|Superiority or Other||Mean Difference (Final Values)|0.231|Standard Error of the Mean|0.028|<|0.0001||95.0|0.177|0.286|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739134|NCT00452400|3201117|Superiority or Other||Mean Difference (Final Values)|0.231|Standard Error of the Mean|0.027|<|0.0001||95.0|0.178|0.284|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739135|NCT00452400|3201117|Superiority or Other||Mean Difference (Final Values)|0.185|Standard Error of the Mean|0.027|<|0.0001||95.0|0.131|0.239|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739136|NCT00452400|3201117|Superiority or Other||Mean Difference (Final Values)|0.155|Standard Error of the Mean|0.027|<|0.0001||95.0|0.101|0.209|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739137|NCT00452400|3201118|Superiority or Other||Mean Difference (Final Values)|0.204|Standard Error of the Mean|0.03|<|0.0001||95.0|0.145|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739138|NCT00452400|3201118|Superiority or Other||Mean Difference (Final Values)|0.203|Standard Error of the Mean|0.03|<|0.0001||95.0|0.144|0.262|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739139|NCT00452400|3201118|Superiority or Other||Mean Difference (Final Values)|0.194|Standard Error of the Mean|0.03|<|0.0001||95.0|0.134|0.253|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739140|NCT00452400|3201118|Superiority or Other||Mean Difference (Final Values)|0.159|Standard Error of the Mean|0.03|<|0.0001||95.0|0.1|0.219|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739141|NCT00452400|3201119|Superiority or Other||Mean Difference (Final Values)|0.247|Standard Error of the Mean|0.029|<|0.0001||95.0|0.191|0.304|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739142|NCT00452400|3201119|Superiority or Other||Mean Difference (Final Values)|0.218|Standard Error of the Mean|0.028|<|0.0001||95.0|0.163|0.273|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739143|NCT00452400|3201119|Superiority or Other||Mean Difference (Final Values)|0.215|Standard Error of the Mean|0.029|<|0.0001||95.0|0.159|0.271|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739144|NCT00452400|3201119|Superiority or Other||Mean Difference (Final Values)|0.187|Standard Error of the Mean|0.028|<|0.0001||95.0|0.131|0.243|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739145|NCT00452400|3201120|Superiority or Other||Median Difference (Final Values)|0.203|Standard Error of the Mean|0.022|<|0.0001||95.0|0.159|0.246|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739146|NCT00452400|3201120|Superiority or Other||Median Difference (Final Values)|0.204|Standard Error of the Mean|0.022|<|0.0001||95.0|0.162|0.247|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739147|NCT00452400|3201120|Superiority or Other||Mean Difference (Final Values)|0.172|Standard Error of the Mean|0.022|<|0.0001||95.0|0.128|0.215|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739148|NCT00452400|3201120|Superiority or Other||Mean Difference (Final Values)|0.133|Standard Error of the Mean|0.022|<|0.0001||95.0|0.09|0.176|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739149|NCT00452400|3201121|Superiority or Other||Mean Difference (Final Values)|0.286|Standard Error of the Mean|0.062|<|0.0001||95.0|0.164|0.407|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739150|NCT00452400|3201121|Superiority or Other||Mean Difference (Final Values)|0.297|Standard Error of the Mean|0.061|<|0.0001||95.0|0.178|0.416|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739151|NCT00452400|3201121|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.062|<|0.0001||95.0|0.159|0.401|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739152|NCT00452400|3201121|Superiority or Other||Mean Difference (Final Values)|0.288|Standard Error of the Mean|0.061|<|0.0001||95.0|0.167|0.409|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739153|NCT00452400|3201122|Superiority or Other||Mean Difference (Final Values)|0.304|Standard Error of the Mean|0.057|<|0.0001||95.0|0.192|0.416|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739154|NCT00452400|3201122|Superiority or Other||Mean Difference (Final Values)|0.311|Standard Error of the Mean|0.056|<|0.0001||95.0|0.201|0.421|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739155|NCT00452400|3201122|Superiority or Other||Mean Difference (Final Values)|0.283|Standard Error of the Mean|0.057|<|0.0001||95.0|0.171|0.395|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739156|NCT00452400|3201122|Superiority or Other||Mean Difference (Final Values)|0.262|Standard Error of the Mean|0.057|<|0.0001||95.0|0.15|0.373|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739157|NCT00452400|3201123|Superiority or Other||Mean Difference (Final Values)|0.225|Standard Error of the Mean|0.034|<|0.0001||95.0|0.157|0.292|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739158|NCT00452400|3201123|Superiority or Other||Mean Difference (Final Values)|0.218|Standard Error of the Mean|0.034|<|0.0001||95.0|0.152|0.284|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739159|NCT00452400|3201123|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.034|<|0.0001||95.0|0.102|0.237|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739160|NCT00452400|3201123|Superiority or Other||Mean Difference (Final Values)|0.164|Standard Error of the Mean|0.034|<|0.0001||95.0|0.097|0.231|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739161|NCT00452400|3201124|Superiority or Other||Mean Difference (Final Values)|0.214|Standard Error of the Mean|0.032|<|0.0001||95.0|0.151|0.277|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739162|NCT00452400|3201124|Superiority or Other||Mean Difference (Final Values)|0.213|Standard Error of the Mean|0.031|<|0.0001||95.0|0.151|0.275|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739163|NCT00452400|3201124|Superiority or Other||Mean Difference (Final Values)|0.162|Standard Error of the Mean|0.032|<|0.0001||95.0|0.099|0.225|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739312|NCT00450112|3201405|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.|
1739164|NCT00452400|3201124|Superiority or Other||Mean Difference (Final Values)|0.141|Standard Error of the Mean|0.032|<|0.0001||95.0|0.078|0.204|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739165|NCT00452400|3201125|Superiority or Other||Mean Difference (Final Values)|0.179|Standard Error of the Mean|0.052||0.0006||95.0|0.077|0.281|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739166|NCT00452400|3201125|Superiority or Other||Mean Difference (Final Values)|0.172|Standard Error of the Mean|0.051||0.0008||95.0|0.072|0.272|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739167|NCT00452400|3201125|Superiority or Other||Mean Difference (Final Values)|0.162|Standard Error of the Mean|0.052||0.0018||95.0|0.061|0.264|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739168|NCT00452400|3201125|Superiority or Other||Mean Difference (Final Values)|0.094|Standard Error of the Mean|0.051||0.0695||95.0|-0.008|0.195|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739169|NCT00452400|3201126|Superiority or Other||Mean Difference (Final Values)|0.148|Standard Error of the Mean|0.052||0.0047||95.0|0.046|0.251|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739170|NCT00452400|3201126|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.051||0.0037||95.0|0.049|0.25|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739171|NCT00452400|3201126|Superiority or Other||Mean Difference (Final Values)|0.171|Standard Error of the Mean|0.052||0.0011||95.0|0.068|0.274|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739172|NCT00452400|3201126|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.052||0.0836||95.0|-0.012|0.192|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739173|NCT00452400|3201127|Superiority or Other||Mean Difference (Final Values)|0.171|Standard Error of the Mean|0.044||0.0001||95.0|0.084|0.258|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739174|NCT00452400|3201127|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.043||0.0001||95.0|0.084|0.255|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739175|NCT00452400|3201127|Superiority or Other||Mean Difference (Final Values)|0.174|Standard Error of the Mean|0.044|<|0.0001||95.0|0.087|0.261|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739176|NCT00452400|3201127|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.044|<|0.0127||95.0|0.024|0.197|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739177|NCT00452400|3201128|Superiority or Other||Mean Difference (Final Values)|0.128|Standard Error of the Mean|0.026|<|0.0001||95.0|0.077|0.179|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739178|NCT00452400|3201128|Superiority or Other||Mean Difference (Final Values)|0.125|Standard Error of the Mean|0.026|<|0.0001||95.0|0.075|0.175|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739179|NCT00452400|3201128|Superiority or Other||Mean Difference (Final Values)|0.121|Standard Error of the Mean|0.026|<|0.0001||95.0|0.07|0.173|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739180|NCT00452400|3201128|Superiority or Other||Mean Difference (Final Values)|0.085|Standard Error of the Mean|0.026|<|0.0011||95.0|0.034|0.136|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739181|NCT00452400|3201129|Superiority or Other||Mean Difference (Final Values)|0.169|Standard Error of the Mean|0.025|<|0.0001||95.0|0.12|0.218|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739182|NCT00452400|3201129|Superiority or Other||Mean Difference (Final Values)|0.128|Standard Error of the Mean|0.024|<|0.0001||95.0|0.08|0.176|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739183|NCT00452400|3201129|Superiority or Other||Mean Difference (Final Values)|0.137|Standard Error of the Mean|0.025|<|0.0001||95.0|0.088|0.186|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739184|NCT00452400|3201129|Superiority or Other||Mean Difference (Final Values)|0.088|Standard Error of the Mean|0.025|<|0.0004||95.0|0.039|0.137|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739185|NCT00452400|3201130|Superiority or Other||Mean Difference (Final Values)|0.132|Standard Error of the Mean|0.027|<|0.0001||95.0|0.08|0.185|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 20 mcg qd minus Placebo||
1739186|NCT00452400|3201130|Superiority or Other||Mean Difference (Final Values)|0.123|Standard Error of the Mean|0.026|<|0.0001||95.0|0.072|0.175|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 10 mcg qd minus Placebo||
1739187|NCT00452400|3201130|Superiority or Other||Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.027|<|0.0003||95.0|0.044|0.149|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 5 mcg qd minus Placebo||
1739313|NCT00450112|3201406|Superiority or Other||||||>|0.1|||||||Fisher Exact||||
1739188|NCT00452400|3201130|Superiority or Other||Mean Difference (Final Values)|0.061|Standard Error of the Mean|0.027|<|0.0233||95.0|0.008|0.113|||ANCOVA|Based on an analysis of covariance with terms for baseline, treatment and center (center random, all other effects fixed)|Olo 2 mcg qd minus Placebo||
1739189|NCT00452387|3201133|Superiority or Other|||||||0.55|||||||Fisher Exact|||The test of association of PSA and imaging response tests the null hypothesis that the proportion of cases exhibiting PSA response is the same for patients with and without a favorable imaging response. A 2x2 table was constructed based on the number of the patients in imaging response (favorable and unfavorable) and PSA response (>50% reduction and <=50% reduction). The Fisher’s exact test was used to test this hypothesis.|
1739190|NCT00452348|3201159|Superiority or Other||Least Squares Mean|0.04||||0.09||95.0|-0.01|0.09|||ANCOVA||||
1739191|NCT00451555|3201194|Superiority|||||||0.7965|||||||Log Rank||||
1739192|NCT00451555|3201194|Superiority|||||||0.4516|||||||Log Rank||||
1739193|NCT00451555|3201194|Superiority|||||||0.5887|||||||Log Rank||||
1739194|NCT00451555|3201195|Superiority|||||||0.9798|||||||Log Rank||||
1739195|NCT00451555|3201195|Superiority|||||||0.7307|||||||Log Rank||||
1739196|NCT00451555|3201195|Superiority|||||||0.8582|||||||Log Rank||||
1739197|NCT00451555|3201196|Superiority|||||||0.6349|||||||Fisher Exact||||
1739198|NCT00451555|3201196|Superiority|||||||0.6721|||||||Fisher Exact||||
1739199|NCT00451555|3201196|Superiority|||||||0.639|||||||Fisher Exact||||
1739200|NCT00451555|3201197|Superiority|||||||0.6242|||||||Fisher Exact||||
1739201|NCT00451555|3201197|Superiority|||||||0.6282|||||||Fisher Exact||||
1739202|NCT00451555|3201197|Superiority|||||||0.6238|||||||Fisher Exact||||
1739203|NCT00451282|3201226|Superiority or Other|||||||0.18|||||||t-test, 2 sided||||
1739204|NCT00451282|3201227|Superiority or Other|||||||0.69|||||||t-test, 2 sided||||
1739205|NCT00451282|3201228|Superiority or Other|||||||0.89|||||||t-test, 2 sided||||
1739206|NCT00451282|3201229|Superiority or Other|||||||0.69|||||||t-test, 2 sided||||
1739207|NCT00451204|3201235|Superiority or Other||Rate ratio|0.52||||0.012|2-Sided|95.0|0.31|0.86|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.|||
1739208|NCT00451204|3201236|Superiority or Other||Rate ratio|0.49||||0.016|2-Sided|95.0|0.28|0.88|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.|||
1739209|NCT00451204|3201237|Superiority or Other||Rate ratio|0.7||||0.179|2-Sided|95.0|0.42|1.17|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.|||
1739210|NCT00451204|3201238|Superiority or Other||Rate ratio|0.63||||0.096|2-Sided|95.0|0.36|1.09|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.|||
1739211|NCT00451204|3201239|Superiority or Other||Rate ratio|0.65||||0.098|2-Sided|95.0|0.39|1.08|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 months, time since dx, previous GA treatment, and previous interferon beta treatment.|||
1739212|NCT00451204|3201240|Superiority or Other||Rate ratio|0.63||||0.077|2-Sided|95.0|0.37|1.05|||negative binomial regression|adjusted for age, BL EDSS score, # of relapses in previous 12 mo, time since dx, previous glatiramer acetate tx, and previous interferon beta tx.|||
1739213|NCT00451191|3201241|Superiority or Other (legacy)||||||<|0.05|||||||Simon's optimal two-stage design|||Simon’s optimal two-stage design was applied to determine whether there was sufficient activity at either of the two dose levels to warrant further investigation. Each patient was considered either a successful or failed response. The response rate or proportion of patients treated successfully was examined in two stages. At both stages, the two dose levels were compared to pre-determined critical cut-off values. Sample size was based on significance level α=0.05 and power 90%.|
1739214|NCT00450658|3201301|Superiority or Other||Risk Difference (RD)|3.9||||0.0017|2-Sided|95.0|0.8|7.1|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.||The secondary efficacy endpoint was the proportion of subjects developing duodenal ulcers throughout 24 weeks of treatment. A summary including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of duodenal ulcers at 24 weeks. The cumulative proportion of subjects developing duodenal ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.|
1739215|NCT00450658|3201302|Superiority or Other||Risk Difference (RD)|8.2||||0.0051|2-Sided|95.0|1.9|14.4|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) and prior upper gastrointestinal ulcer history (Yes/No) at randomization.|||
1739216|NCT00450658|3201303|Superiority or Other||Risk Difference (RD)|9.5||||0.0018|2-Sided|95.0|3.0|15.9|||Cochran-Mantel-Haenszel|CMH test stratified by use of low-dose aspirin (Yes/No) and prior upper gastrointestinal ulcer history (Yes/No) at randomization.||The primary efficacy endpoint was the proportion of subjects developing UGI (gastric and/or duodenal) ulcers throughout 24 weeks of treatment. A summary including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of UGI ulcers at 24 weeks. The cumulative proportion of subjects developing UGI ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history at randomization.|
1739217|NCT00450619|3201309|Superiority or Other||Hazard Ratio (HR)|0.71||||0.3|2-Sided|95.0|0.37|1.35|||Kaplan Meier||||
1739218|NCT00450619|3201313|Superiority or Other||Hazard Ratio (HR)|0.5019||||0.046|2-Sided|95.0|||||Hazard Ratio||||
1739219|NCT00450619|3201313|Superiority or Other||Hazard Ratio (HR)|0.5019||||0.041|2-Sided|95.0|||||Log Rank||||
1739220|NCT00450580|3201322|Non-Inferiority or Equivalence|Non-inferiority can be concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms is greater than -12%.|Risk Difference (RD)|-0.9||||||95.0|-11.4|9.5|||||||
1739568|NCT00446992|3201802|Superiority or Other||||||=|0|||||||Univariate linear regression|||Baseline compared to Week 16|
1739221|NCT00450437|3201336|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.|Vaccine group difference|16.0|||||2-Sided|95.0|9.0|23.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.|
1739222|NCT00450437|3201336|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.|Vaccine group difference|9.0|||||2-Sided|95.0|2.0|17.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.|
1739223|NCT00450437|3201336|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.|Vaccine group difference|9.0|||||2-Sided|95.0|3.0|15.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine. MenC.|
1739224|NCT00450437|3201336|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.|Vaccine group difference|-1.0|||||2-Sided|95.0|-7.0|5.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.|
1739225|NCT00450437|3201338|Non-Inferiority or Equivalence|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y with respect to the immune response.|hSBA GMT ratios|2.49|||||2-Sided|95.0|2.11|2.95||||||"Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenY.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain Y at 1 month after vaccination was to be above 0.5."|
1739226|NCT00450437|3201338|Non-Inferiority or Equivalence|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain W with respect to the immune response.|hSBA GMT ratios|1.76|||||2-Sided|95.0|1.51|2.05||||||"Non-inferiority of Investigational MenACWY vaccine vs. Licensed MenACWY vaccine, MenW.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain W at 1 month after vaccination was to be above 0.5."|
1739227|NCT00450437|3201338|Non-Inferiority or Equivalence|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain C with respect to the immune response.|hSBA GMT ratios|1.4|||||2-Sided|95.0|1.17|1.67||||||"Non-inferiority of Investigation MenACWY vaccine vs. Licensed MenACWY vaccine, MenC.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain C at 1 month after vaccination was to be above 0.5."|
1739228|NCT00450437|3201338|Non-Inferiority or Equivalence|The equivalence lower limit was 0.5. If the lower limit of two sided 95% CIs for the ratio of the hSBA GMT (GMT for investigational vaccine / GMT for licensed vaccine) at one month following vaccination was above this limit, Investigational MenACWY vaccine would be non-inferior to Licensed MenACWY vaccine for Neisseria Meningitidis strain A with respect to the immune response.|hSBA GMT ratios|1.32|||||2-Sided|95.0|1.12|1.56||||||"Non-inferiority of Investigational MenACWY Vaccine vs. Licensed MenACWY vaccine, MenA.~The study would be considered a success if the lower limit of the two-sided 95% CIs for the hSBA GMT ratios comparing Investigational MenACWY vaccine to Licensed MenACWY vaccine for Neisseria Meningitidis strain A at 1 month after vaccination was to be above 0.5."|
1739229|NCT00450437|3201339|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is > -10%.|Vaccine group difference|12.0|||||2-Sided|95.0|9.0|16.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.|
1739230|NCT00450437|3201339|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is > -10%.|Vaccine group difference|6.0|||||2-Sided|95.0|3.0|8.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.|
1739231|NCT00450437|3201339|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is > -10%.|Vaccine group difference|1.0|||||2-Sided|95.0|-1.0|4.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.|
1739232|NCT00450437|3201339|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:4 one month after vaccination is > -10%.|Vaccine group difference|3.0|||||2-Sided|95.0|-1.0|7.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.|
1739314|NCT00449956|3201411|Non-Inferiority or Equivalence|Non-inferiority margin = 1.2 mmHg|Mean Difference (Final Values)|0.28||||||95.0|-0.22|0.78|||||An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.||
1739233|NCT00450437|3201339|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is > -10%.|Vaccine group difference|15.0|||||2-Sided|95.0|12.0|20.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.|
1739234|NCT00450437|3201339|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with with hSBA ≥ 1:8 one month after vaccination is > -10%.|Vaccine group difference|6.0|||||2-Sided|95.0|4.0|9.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.|
1739235|NCT00450437|3201339|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is > -10%.|Vaccine group difference|3.0|||||2-Sided|95.0|0.0|7.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.|
1739236|NCT00450437|3201339|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with hSBA ≥ 1:8 one month after vaccination is > -10%.|Vaccine group difference|4.0|||||2-Sided|95.0|0.0|8.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.|
1739237|NCT00450437|3201339|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is > -10%.|Vaccine group difference|23.0|||||2-Sided|95.0|19.0|28.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.|
1739238|NCT00450437|3201339|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is > -10%.|Vaccine group difference|15.0|||||2-Sided|95.0|11.0|20.0||||||Vaccine group difference Investigational MenACWY vaccine vs.Licensed MenaCWY vaccine, MenW.|
1739239|NCT00450437|3201339|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is > -10%.|Vaccine group difference|5.0|||||2-Sided|95.0|1.0|9.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.|
1739240|NCT00450437|3201339|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for percentage of subjects with seroresponse one month after vaccination is > -10%.|Vaccine group difference|4.0|||||2-Sided|95.0|0.0|8.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.|
1739241|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||2-Sided|95.0|-5.0|3.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).|
1739242|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-4.0|||||2-Sided|95.0|-9.0|0.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).|
1739243|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||2-Sided|95.0|-8.0|1.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).|
1739244|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||2-Sided|95.0|-2.0|3.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).|
1739315|NCT00449956|3201411|Superiority or Other||Mean Difference (Final Values)|-0.68||||||95.0|-1.3|-0.06|||||An analysis of covariance model with a factor for treatment and time-matched baseline as a covariate was used to compute 95% confidence intervals.||
1739316|NCT00449930|3201412|Superiority or Other||Risk Difference (RD)|-1.0||||||95.0|-2.4|0.2|||||"Difference (sitagliptin minus metformin) in the percentage of patients with vomiting.~Wilson Score method was used for the 95% CI."||
1739245|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||2-Sided|95.0|-4.0|2.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).|
1739246|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||2-Sided|95.0|-5.0|1.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).|
1739247|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||2-Sided|95.0|-4.0|4.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).|
1739248|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||2-Sided|95.0|-4.0|4.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).|
1739249|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||2-Sided|95.0|-3.0|5.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%)|
1739250|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||2-Sided|95.0|-8.0|4.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).|
1739251|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-5.0|||||2-Sided|95.0|-11.0|1.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).|
1739252|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:4 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||2-Sided|95.0|-9.0|4.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:4 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).|
1739253|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|0.0|||||2-Sided|95.0|-5.0|5.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).|
1739340|NCT00449644|3201472|Superiority or Other||Risk Difference (RD)|21.2|Standard Error of the Mean|7.9||0.008|2-Sided|95.0|5.59|36.83|||Regression, Logistic|Treatment as covariate||Week 24|
1739254|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||2-Sided|95.0|-8.0|2.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).|
1739255|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||2-Sided|95.0|-8.0|2.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).|
1739256|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||2-Sided|95.0|-2.0|4.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).|
1739257|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||2-Sided|95.0|-4.0|2.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).|
1739258|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-2.0|||||2-Sided|95.0|-5.0|1.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).|
1739259|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||2-Sided|95.0|-3.0|6.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).|
1739260|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|3.0|||||2-Sided|95.0|-2.0|7.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).|
1739261|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|2.0|||||2-Sided|95.0|-3.0|6.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).|
1739262|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||2-Sided|95.0|-9.0|4.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).|
1739569|NCT00446992|3201803|Superiority or Other||||||=|0|||||||Intervariate|||Baseline compared to Week 16|
1739263|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||2-Sided|95.0|-12.0|0.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).|
1739264|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for the percentage of subjects with hSBA titer ≥1:8 at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||2-Sided|95.0|-10.0|3.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8 comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).|
1739265|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|7.0|||||2-Sided|95.0|0.0|14.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).|
1739266|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|1.0|||||2-Sided|95.0|-6.0|8.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).|
1739267|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||2-Sided|95.0|-13.0|1.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y were contained within the equivalence interval (-10%, 10%).|
1739268|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|10.0|||||2-Sided|95.0|4.0|17.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).|
1739269|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|4.0|||||2-Sided|95.0|-3.0|11.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).|
1739270|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||2-Sided|95.0|-13.0|0.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W were contained within the equivalence interval (-10%, 10%).|
1739271|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|-1.0|||||2-Sided|95.0|-6.0|5.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).|
1739317|NCT00449930|3201413|Superiority or Other||Risk Difference (RD)|-1.7||||0.103||95.0|-4.0|0.3|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with abdominal pain.~Wilson Score method was used for the 95% CI."||
1739272|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|4.0|||||2-Sided|95.0|-1.0|10.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).|
1739273|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|Vaccine group difference|5.0|||||2-Sided|95.0|0.0|10.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C were contained within the equivalence interval (-10%, 10%).|
1739274|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||2-Sided|95.0|-9.0|4.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).|
1739275|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-6.0|||||2-Sided|95.0|-12.0|0.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).|
1739276|NCT00450437|3201340|Non-Inferiority or Equivalence|The equivalence margin was (-10%, 10%). If the two sided 95% CIs for percentage of subjects with seroresponse at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|Vaccine group difference|-3.0|||||2-Sided|95.0|-10.0|3.0||||||Lot-to-lot consistency would be concluded if the two-sided 95% confidence intervals (CIs) for the percentage of subjects with seroresponse comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A were contained within the equivalence interval (-10%, 10%).|
1739277|NCT00450437|3201341|Non-Inferiority or Equivalence|MenACWY was considered noninferior to Menactra if the upper limit of the two-sided 95% CI of the difference in the percentage of subjects experiencing at least one severe systemic reaction [MenACWY minus Menactra] was less than 6%.|Vaccine group difference|1.0|||||2-Sided|95.0|-1.0|2.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, safety.|
1739278|NCT00450437|3201342|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.|Vaccine group difference|27.0|||||2-Sided|95.0|20.0|33.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenY.|
1739279|NCT00450437|3201342|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.|Vaccine group difference|12.0|||||2-Sided|95.0|6.0|18.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenW.|
1739280|NCT00450437|3201342|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.|Vaccine group difference|2.0|||||2-Sided|95.0|-2.0|7.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenC.|
1739281|NCT00450437|3201342|Non-Inferiority or Equivalence|Immunogenicity of the Investigational MenACWY vaccine would be considered non-inferior to that of the Licensed MenACWY vaccine if the lower limit of the two-sided CI for the between group difference (investigational vaccine minus licensed vaccine) in percentage of seroresponders one month after vaccination is > -10%.|Vaccine group difference|8.0|||||2-Sided|95.0|3.0|14.0||||||Vaccine group difference Investigational MenACWY vaccine vs. Licensed MenaCWY vaccine, MenA.|
1739282|NCT00450437|3201343|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.16|||||2-Sided|95.0|0.89|1.5||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).|
1739318|NCT00449930|3201414|Superiority or Other||Risk Difference (RD)|-1.9||||0.032||95.0|-3.9|-0.2|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with nausea.~Wilson Score method was used for the 95% CI."||
1739283|NCT00450437|3201343|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.91|||||2-Sided|95.0|0.7|1.18||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).|
1739284|NCT00450437|3201343|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain Y with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.79|||||2-Sided|95.0|0.61|1.02||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain Y at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).|
1739285|NCT00450437|3201343|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval for all pairs of vaccine lots, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.35|||||2-Sided|95.0|1.09|1.67||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).|
1739286|NCT00450437|3201343|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.06|||||2-Sided|95.0|0.86|1.13||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).|
1739287|NCT00450437|3201343|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain W with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.79|||||2-Sided|95.0|0.63|0.97||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain W at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).|
1739288|NCT00450437|3201343|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.9|||||2-Sided|95.0|0.68|1.2||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).|
1739289|NCT00450437|3201343|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.33|||||2-Sided|95.0|1.0|1.77||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).|
1739290|NCT00450437|3201343|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain C with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.2|||||2-Sided|95.0|0.9|1.6||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain C at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).|
1739291|NCT00450437|3201343|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 2 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|1.06|||||2-Sided|95.0|0.81|1.38||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 2 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).|
1739319|NCT00449930|3201415|Superiority or Other||Risk Difference (RD)|-7.3|||<|0.001||95.0|-10.6|-4.2|||Fisher Exact||"Difference (sitagliptin minus metformin) in the percentage of patients with diarrhea.~Wilson Score method was used for the 95% Confidence Interval (CI)."||
1739341|NCT00449644|3201473|Superiority or Other||Risk Difference (RD)|8.9|Standard Error of the Mean|15.02||0.5564|2-Sided|95.0|-21.37|39.18|||Regression, Logistic|Treatment as covariate||Week 104 (Stage 1 Trial End)|
1739292|NCT00450437|3201343|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 3 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.95|||||2-Sided|95.0|0.73|1.23||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 3 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).|
1739293|NCT00450437|3201343|Non-Inferiority or Equivalence|The equivalence margin was (0.5, 2.0). If the two sided 95% CIs for the ratio of the hSBA GMT at one month following vaccination was within this equivalence interval, Investigational vaccine MenACWY Lot 1 and Investigational vaccine MenACWY Lot 2 would be equivalent for Neisseria Meningitidis strain A with respect to the immune response to the vaccine lot.|hSBA GMT ratios|0.89|||||2-Sided|95.0|0.68|1.16||||||The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing Investigational vaccine MenACWY Lot 1 to Investigational vaccine MenACWY Lot 2 for Neisseria Meningitidis strain A at 1 month after vaccination was contained within the equivalence interval (0.5, 2.0).|
1739294|NCT00450411|3201355|Other|||||||||||||||||It was projected that ≤10% of patients would experience late treatment-related GI/GU AEs under the protocol treatment (alternative hypothesis). A rate of ≥20% was considered unacceptable (null hypothesis). With a one-sided significance level of 0.05, it was estimated that 87 analyzable patients were required to detect the above-mentioned effect size with an 85% statistical power using Fleming’s multiple testing procedure with two interim analyses and one final analysis.|Stopping Rules for a Late GI/GU Adverse Event: For 44 patients, if ≤2 then reject H0, if ≥8 then reject HA; for 73 patients, if ≤7 then reject H0, if ≥10 then reject HA; for 87 patients, if ≤10 then reject H0, if ≥11 then reject HA.
1739295|NCT00450294|3201368|Superiority or Other||||||<|0.001||||||That the means at the different timepoints would not all be equal.|ANOVA|||Repeated measures anova with post hoc t-tests using tukey's correction.|
1739296|NCT00450294|3201369|Superiority or Other||||||<|0.001||||||That the means at the different timepoints would not all be equal.|ANOVA|||Repeated measures anova with post hoc t-tests using tukey's correction.|
1739297|NCT00450216|3201380|Superiority or Other||Risk Difference (RD)|3.8||||0.0006|2-Sided|95.0|1.0|6.8||CMH test stratified by use of low-dose aspirin (yes/no) and prior UGI ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The secondary efficacy endpoint was the number of participants developing duodenal ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of duodenal ulcers at 24 weeks. The cumulative number of participants developing duodenal ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prio UGI ulcer history at randomization.|
1739298|NCT00450216|3201381|Superiority or Other||Risk Difference (RD)|11.8|||<|0.0001|2-Sided|95.0|6.1|17.6||CMH test stratified by use of low-dose aspirin (yes/no) and prior UGI ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The secondary efficacy endpoint was the number of participants developing UGI (i.e., gastric and/or duodenal) ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of UGI ulcers at 24 weeks. The cumulative number of participants developing UGI ulcers at 24 weeks was analyzed using the CMH test stratified by use of low-dose aspirin and prior UGI ulcer history.|
1739299|NCT00450216|3201382|Superiority or Other||Risk Difference (RD)|9.8|||<|0.0001|2-Sided|95.0|4.4|15.3||CMH test stratified by use of low-dose aspirin (yes/no) and prior upper gastrointestinal (UGI) ulcer history (yes/no) at randomization.|Cochran-Mantel-Haenszel|||The primary efficacy endpoint was the number of participants developing gastric ulcers throughout 24 weeks of treatment. A summary, including cumulative frequency and percentage with associated 95% confidence intervals was produced for the observational incidences of gastric ulcers at 24 weeks. The cumulative number of participants developing gastric ulcers at 24 weeks was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by use of low-dose aspirin and prior UGI ulcer history.|
1739300|NCT00450177|3201393|Other|||||||0.03|||||||Chi-squared||||
1739301|NCT00450112|3201399|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.|
1739302|NCT00450112|3201399|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.|
1739303|NCT00450112|3201400|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.|
1739304|NCT00450112|3201400|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.|
1739305|NCT00450112|3201402|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.|
1739306|NCT00450112|3201402|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed..|
1739307|NCT00450112|3201403|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.|
1739308|NCT00450112|3201403|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.|
1739309|NCT00450112|3201404|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.|
1739310|NCT00450112|3201404|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 2Gel-200 group; no between-group test was performed.|
1739311|NCT00450112|3201405|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||One-sample 2 sided t-test of change from baseline within 1PBS1Gel-200 group; no between-group test was performed.|
1739407|NCT00448630|3201568|Superiority or Other||||||,|0.0193|||||||Wilcoxon (Mann-Whitney)||||
1739320|NCT00449930|3201416|Non-Inferiority or Equivalence|The pre-specified non-inferiority margin was 0.4%; i.e., non-inferiority required that the upper boundary of the 95% confidence interval for the treatment difference (sitagliptin minus metformin) to be less than 0.4%.|Mean Difference (Net)|0.14|Standard Deviation|0.57||||95.0|0.06|0.21|||||Based on an analysis of covariance (ANCOVA) model with terms for treatment group and baseline value.||
1739321|NCT00449865|3201417|Superiority or Other|||||||0.45|||||||Global Statistical Test|The global statistical test yielded t = −0.75 (2-sided p-value = .45, df=1865.8).|||
1739322|NCT00449696|3201422|Superiority or Other|||||||0.041|||||||Wilcoxon (Mann-Whitney)||||
1739323|NCT00449696|3201423|Superiority or Other||Mean Difference (Net)|3.56||||0.166||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.||
1739324|NCT00449696|3201424|Superiority or Other||Mean Difference (Net)|0.92||||0.746||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.||
1739325|NCT00449696|3201425|Superiority or Other||Mean Difference (Net)|6.39||||0.037||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.||
1739326|NCT00449696|3201426|Superiority or Other||||||>|0.05||||||P-value for physical component scores, physical function subscale, role physical subscale, and bodily pain subscale.|Wilcoxon (Mann-Whitney)||||
1739327|NCT00449696|3201427|Superiority or Other||Odds Ratio (OR)|1.27||||0.242||95.0||||P-value for OMERACT-OARSI response.|Generalized Estimating Equation Model||||
1739328|NCT00449696|3201427|Superiority or Other||Odds Ratio (OR)|1.59||||0.022||95.0||||P-value for strict OMERACT-OARSI response.|Generalized Estimating Equation Model||||
1739329|NCT00449696|3201428|Superiority or Other||Mean Difference (Net)|5.64||||0.058||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.||
1739330|NCT00449696|3201429|Superiority or Other||Mean Difference (Net)|5.42||||0.071||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.||
1739331|NCT00449696|3201430|Superiority or Other||Mean Difference (Net)|4.91||||0.122||95.0|||||Quadratic Spline Model||Tested superiority of Gel-200 using quadratic spline model for difference between Gel-200 and PBS placebo. Only difference between groups was presented by the pre-specified model as primary endpoint.||
1739332|NCT00449670|3201470|Equivalence|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the [0.5 ; 2] clinical limit interval.|Adjusted GMT ratio|0.99|||||2-Sided|95.0|0.8|1.23||||||Demonstration of the consistency of the immune response (in terms of geometric mean titer [GMT] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 3 and Lot 4).|
1739333|NCT00449670|3201470|Equivalence|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the [0.5 ; 2] clinical limit interval.|Adjusted GMT ratio|1.04|||||2-Sided|95.0|0.84|1.29||||||Demonstration of the consistency of the immune response (in terms of geometric mean titer [GMT] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 2 and Lot 4).|
1739334|NCT00449670|3201470|Equivalence|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the [0.5 ; 2] clinical limit interval.|Adjusted GMT ratio|1.05|||||2-Sided|95.0|0.85|1.3||||||Demonstration of the consistency of the immune response (in terms of geometric mean titer [GMT] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 2 and Lot 3).|
1739335|NCT00449670|3201470|Equivalence|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the [0.5 ; 2] clinical limit interval.|Adjusted GMT ratio|0.85|||||2-Sided|95.0|0.68|1.05||||||Demonstration of the consistency of the immune response (in terms of geometric mean titer [GMT] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 4).|
1739336|NCT00449670|3201470|Equivalence|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the [0.5 ; 2] clinical limit interval.|Adjusted GMT ratio|0.85|||||2-Sided|95.0|0.69|1.06||||||Demonstration of the consistency of the immune response (in terms of geometric mean titer [GMT] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 3).|
1739337|NCT00449670|3201470|Equivalence|The lot-to-lot consistency 21 days after Dose 2 was demonstrated if, for all pairs of lots, the two-sided 95% CIs for the ratio of A/Vietnam/1194/2004 HI antibody GMT was within the [0.5 ; 2] clinical limit interval.|Adjusted GMT ratio|0.81||||||95.0|0.66|1.01||||||Demonstration of the consistency of the immune response (in terms of geometric mean titer [GMT] ratio for anti-hemagglutinin (anti-HA) antibody response against the A/Vietnam/1194/2004 strain 21 days after the second vaccination) elicited by two compositions of H5N1 adjuvanted vaccine (Lot 1 and Lot 2).|
1739338|NCT00449644|3201472|Superiority or Other||Risk Difference (RD)|18.2|Standard Error of the Mean|8.54||0.035|2-Sided|95.0|1.28|35.08|||Regression, Logistic|Treatment as covariate||Week 120|
1739339|NCT00449644|3201472|Superiority or Other||Risk Difference (RD)|15.2|Standard Error of the Mean|8.27||0.069|2-Sided|95.0|-1.21|31.51|||Regression, Logistic|Treatment as covariate||Week 72|
1739342|NCT00449644|3201473|Superiority or Other||Risk Difference (RD)|15.7|Standard Error of the Mean|13.12||0.237|2-Sided|95.0|-10.7|42.17|||Regression, Logistic|Treatment as covariate||Week 24|
1739343|NCT00449644|3201473|Superiority or Other||Risk Difference (RD)|38.9|Standard Error of the Mean|12.38||0.003|2-Sided|95.0|13.97|63.88|||Regression, Logistic|Treatment as covariate||Week 8|
1739344|NCT00449644|3201474|Superiority or Other||Odds Ratio (OR)|1.65||||0.029|2-Sided|95.0|1.05|2.59|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.||MGIT negative (Responders)|
1739345|NCT00449644|3201475|Superiority or Other||Odds Ratio (OR)|3.14||||0.0022|2-Sided|95.0|1.51|6.53|||Cox-proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.|||
1739346|NCT00449644|3201476|Superiority or Other||Hazard Ratio (HR)|2.44|||<|0.0001|2-Sided|95.0|1.57|3.8|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.|||
1739347|NCT00449644|3201477|Superiority or Other||Hazard Ratio (HR)|11.77||||0.0034|2-Sided|95.0|2.26|61.23|||Cox proportional hazards model|Treatment, lung cavitation and pooled center were used as covaritates.|||
1739348|NCT00449176|3201488|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.19|<|0.001||95.0|-1.22|-0.47|||ANCOVA|||The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 0.7 with an SD of 2.7, 314 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a treatment group for the study was 942.|
1739349|NCT00449150|3201494|Superiority or Other||LS means estimate|-0.252||||0.6699||95.0|-1.41|0.91|||ANOVA||||
1739350|NCT00449150|3201494|Superiority or Other||LS means estimate|0.055||||0.926||95.0|-1.1|1.21|||ANOVA||||
1739351|NCT00449150|3201494|Superiority or Other||LS means estimate|-0.198||||0.7424|2-Sided|95.0|-1.38|0.98|||ANOVA||||
1739352|NCT00449072|3201500|Superiority or Other|||||||0.0142||||||The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.|Mixed model for repeated measures|||Statistical Analysis for Day 360|
1739353|NCT00449072|3201500|Superiority or Other|||||||0.4488|||||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 240|
1739354|NCT00449072|3201500|Superiority or Other|||||||0.2445|||||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 120|
1739355|NCT00449072|3201501|Superiority or Other|||||||0.0207|||||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical analysis for Day 360|
1739356|NCT00449072|3201501|Superiority or Other|||||||0.1247|||||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical analysis for Day 240|
1739357|NCT00449072|3201501|Superiority or Other|||||||0.0951|||||||Mixed model for repeated measures|The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor.||Statistical Analysis for Day 120|
1739358|NCT00449072|3201502|Superiority or Other||LS mean Difference|-0.02||||0.8854|2-Sided|95.0|-0.23|0.2|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Nasal Itching|
1739359|NCT00449072|3201502|Superiority or Other||LS Mean Difference|0.09||||0.402|2-Sided|95.0|-0.12|0.29|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Sneezing|
1739360|NCT00449072|3201502|Superiority or Other||LS Mean Difference|-0.04||||0.7193|2-Sided|95.0|-0.24|0.17|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in Nasal Discharge|
1739361|NCT00449072|3201502|Superiority or Other||LS Mean Differerence|-0.15||||0.1963|2-Sided|95.0|-0.37|0.08|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.|Change in nasal stuffiness|
1739362|NCT00449072|3201503|Superiority or Other||LS Mean Difference|-0.12||||0.7341|2-Sided|95.0|-0.83|0.58|||ANCOVA||The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model.||
1739363|NCT00449072|3201504|Superiority or Other||Difference (LS Mean)|-0.45||||0.0096|2-Sided|95.0|-0.78|-0.11|||ANCOVA|The treatment arm, age group (at Visit 1) and sex were fixed effects, and baseline growth velocity was a covariate in the ANCOVA model|||
1739364|NCT00449033|3201521|Superiority or Other||Difference in Disease Control|0.97||||0.3902||95.0|-5.87|7.81|||Cochran-Mantel-Haenszel|Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.|||
1739365|NCT00449033|3201522|Superiority or Other||Difference in Tumour Response (CR+PR)|-1.92||||0.2733||95.0|-8.19|4.34|||Cochran-Mantel-Haenszel|Two treatment groups compared using a CMH test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.|||
1739366|NCT00449033|3201523|Superiority or Other||Hazard Ratio (HR)|0.73||||0.0004||95.0|0.6|0.88|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.|||
1739367|NCT00449033|3201524|Superiority or Other||Hazard Ratio (HR)|0.83||||0.008||95.0|0.71|0.97|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.|||
1739368|NCT00449033|3201526|Superiority or Other||Hazard Ratio (HR)|1.01||||0.563||95.0|0.87|1.18|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same factors as randomization plus histology.|||
1739408|NCT00448630|3201568|Superiority or Other||||||,|0.004||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739369|NCT00449033|3201527|Superiority or Other||Hazard Ratio (HR)|0.98||||0.401||95.0|0.83|1.16|||Log Rank|Two treatment groups compared using a log-rank test with one-sided alpha of 0.025 stratified by the same stratification factors as randomization.||Sample size based on the primary efficacy endpoint of OS in the ITT (non-squamous) population. Clinically meaningful improvement defined as 30% increase in median OS (that is, a hazard ratio of 0.76923, Sorafenib+GC over Placebo+GC). With one-sided alpha of 0.025, power of 86% and a randomization ratio of 1:1 between Sorafenib+GC and Placebo+GC, and one formal final analysis of OS performed, a total of 544 events (deaths) were required.|
1739370|NCT00448747|3201554|Other||Mean Difference (Final Values)|-2.3|Standard Deviation|16.25|||2-Sided||||||||||
1739371|NCT00448747|3201554|Other||Mean Difference (Final Values)|-5.1|Standard Deviation|9.57|||2-Sided|||||||||Summary of IGF-1 before and after AEZS-130 administration: post - pre differences|
1739372|NCT00448747|3201555|Other|Misclassification|misclassification (percent)|13.0|||||2-Sided|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.|
1739373|NCT00448747|3201555|Other|Specificity|Specificity (percent)|92.0|||||2-Sided|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.|
1739374|NCT00448747|3201555|Other|Sensitivity|sensitivity (percent)|82.0|||||2-Sided|||||||||ROC analysis on peak GH concentrations in response to macimorelin: GH cut point of 2.7 ng/mL.|
1739375|NCT00448747|3201555|Other||ROC AUC|0.923|||||1-Sided|99.0|0.85|||||||Summary of ROC Analyses following macimorelin administration.|
1739376|NCT00448669|3201563|Superiority or Other (legacy)|||||||0.79|||||||Fisher Exact|||Fisher’s Exact Test was performed to test for differences between the treatment groups in terms of adherence based on pill count.|
1739377|NCT00448669|3201564|Superiority or Other (legacy)||Odds Ratio (OR)|1.16||||0.004|2-Sided|95.0|1.05|1.28|||Regression, Logistic|In this univariate model with the analysis of number of condomless sex acts, our model estimates the odds of reporting no condomless sex acts.||"A logistic regression was used to estimate the odds of reporting zero condomless sex acts. The longitudinal dependent variable (number of condomless sex acts) was defined as:~Number of condomless vaginal sexual acts with both casual and main partners among those who reported having had at least one sexual partner in the previous 30 days."|
1739378|NCT00448669|3201565|Superiority or Other (legacy)||Efficacy|62.2||||0.03|2-Sided|95.0|21.5|83.4|||Regression, Cox|||The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF–FTC and those assigned to receive placebo. The primary hypothesis was that TDF–FTC, as compared with placebo, would reduce the rate of HIV infection by at least 65%, with a predefined lower boundary for the 95% confidence interval of 10%.|
1739379|NCT00448669|3201566|Superiority or Other (legacy)|||||||0.003|||||||Regression, Cox|||Safety analyses were performed in the intention-to-treat cohort. Primary safety end points included the frequency of adverse clinical or laboratory events.|
1739380|NCT00448630|3201567|Superiority or Other|||||||0.174||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739381|NCT00448630|3201567|Superiority or Other|||||||0.987||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739382|NCT00448630|3201567|Superiority or Other|||||||0.593||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739383|NCT00448630|3201567|Superiority or Other||||||<|0.001||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739384|NCT00448630|3201567|Superiority or Other||||||<|0.978||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739385|NCT00448630|3201567|Superiority or Other||||||<|0.039||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739386|NCT00448630|3201567|Superiority or Other||||||<|0.077||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739387|NCT00448630|3201568|Superiority or Other|||||||0.5587|||||||Wilcoxon (Mann-Whitney)||||
1739388|NCT00448630|3201568|Superiority or Other|||||||0.0014|||||||Wilcoxon (Mann-Whitney)||||
1739389|NCT00448630|3201568|Superiority or Other|||||||0.0079|||||||Wilcoxon (Mann-Whitney)||||
1739390|NCT00448630|3201568|Superiority or Other|||||||0.6082|||||||Wilcoxon (Mann-Whitney)||||
1739391|NCT00448630|3201568|Superiority or Other|||||||0.1774|||||||Wilcoxon (Mann-Whitney)||||
1739392|NCT00448630|3201568|Superiority or Other||||||,|0|||||||Wilcoxon (Mann-Whitney)||||
1739393|NCT00448630|3201568|Superiority or Other||||||,|0.5672|||||||Wilcoxon (Mann-Whitney)||||
1739394|NCT00448630|3201568|Superiority or Other||||||,|0.2351|||||||Wilcoxon (Mann-Whitney)||||
1739395|NCT00448630|3201568|Superiority or Other||||||,|0.0127|||||||Wilcoxon (Mann-Whitney)||||
1739396|NCT00448630|3201568|Superiority or Other||||||,|0.7193|||||||Wilcoxon (Mann-Whitney)||||
1739397|NCT00448630|3201568|Superiority or Other||||||,|0.3968|||||||Wilcoxon (Mann-Whitney)||||
1739398|NCT00448630|3201568|Superiority or Other||||||,|0.8158|||||||Wilcoxon (Mann-Whitney)||||
1739399|NCT00448630|3201568|Superiority or Other||||||,|0.0063|||||||Wilcoxon (Mann-Whitney)||||
1739400|NCT00448630|3201568|Superiority or Other||||||,|0.2309|||||||Wilcoxon (Mann-Whitney)||||
1739401|NCT00448630|3201568|Superiority or Other||||||,|0.26|||||||Wilcoxon (Mann-Whitney)||||
1739402|NCT00448630|3201568|Superiority or Other||||||,|0.0016|||||||Wilcoxon (Mann-Whitney)||||
1739403|NCT00448630|3201568|Superiority or Other||||||,|0.0116|||||||Wilcoxon (Mann-Whitney)||||
1739404|NCT00448630|3201568|Superiority or Other||||||,|0.3172|||||||Wilcoxon (Mann-Whitney)||||
1739405|NCT00448630|3201568|Superiority or Other||||||,|0.0002|||||||Wilcoxon (Mann-Whitney)||||
1739406|NCT00448630|3201568|Superiority or Other||||||,|0.0065|||||||Wilcoxon (Mann-Whitney)||||
1739409|NCT00448630|3201568|Superiority or Other||||||,|0.04||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739410|NCT00448630|3201568|Superiority or Other||||||,|0.282||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739411|NCT00448630|3201568|Superiority or Other||||||<|0.001||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739412|NCT00448630|3201568|Superiority or Other||||||<|0.012||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739413|NCT00448630|3201568|Superiority or Other||||||<|0.01||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739414|NCT00448630|3201568|Superiority or Other||||||<|0.197||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739415|NCT00448630|3201569|Superiority or Other|||||||0.8952|||||||Wilcoxon (Mann-Whitney)||||
1739416|NCT00448630|3201569|Superiority or Other|||||||0.0005|||||||Wilcoxon (Mann-Whitney)||||
1739417|NCT00448630|3201569|Superiority or Other|||||||0.0003|||||||Wilcoxon (Mann-Whitney)||||
1739418|NCT00448630|3201569|Superiority or Other|||||||0.5153|||||||Wilcoxon (Mann-Whitney)||||
1739419|NCT00448630|3201569|Superiority or Other|||||||0.2589|||||||Wilcoxon (Mann-Whitney)||||
1739420|NCT00448630|3201569|Superiority or Other|||||||1e-06|||||||Wilcoxon (Mann-Whitney)||||
1739421|NCT00448630|3201569|Superiority or Other|||||||0.6263|||||||Wilcoxon (Mann-Whitney)||||
1739422|NCT00448630|3201569|Superiority or Other|||||||0.2587|||||||Wilcoxon (Mann-Whitney)||||
1739423|NCT00448630|3201569|Superiority or Other|||||||0.0024|||||||Wilcoxon (Mann-Whitney)||||
1739424|NCT00448630|3201569|Superiority or Other|||||||0.7386|||||||Wilcoxon (Mann-Whitney)||||
1739425|NCT00448630|3201569|Superiority or Other|||||||0.9081|||||||Wilcoxon (Mann-Whitney)||||
1739426|NCT00448630|3201569|Superiority or Other|||||||0.8297|||||||Wilcoxon (Mann-Whitney)||||
1739427|NCT00448630|3201569|Superiority or Other|||||||2e-05|||||||Wilcoxon (Mann-Whitney)||||
1739428|NCT00448630|3201569|Superiority or Other|||||||0.2383|||||||Wilcoxon (Mann-Whitney)||||
1739429|NCT00448630|3201569|Superiority or Other|||||||0.1976|||||||Wilcoxon (Mann-Whitney)||||
1739430|NCT00448630|3201569|Superiority or Other|||||||0.0386|||||||Wilcoxon (Mann-Whitney)||||
1739431|NCT00448630|3201569|Superiority or Other|||||||0.0095|||||||Wilcoxon (Mann-Whitney)||||
1739432|NCT00448630|3201569|Superiority or Other|||||||0.0201|||||||Wilcoxon (Mann-Whitney)||||
1739433|NCT00448630|3201569|Superiority or Other|||||||9e-05|||||||Wilcoxon (Mann-Whitney)||||
1739434|NCT00448630|3201569|Superiority or Other|||||||0.0057|||||||Wilcoxon (Mann-Whitney)||||
1739435|NCT00448630|3201569|Superiority or Other|||||||0.0007|||||||Wilcoxon (Mann-Whitney)||||
1739436|NCT00448630|3201569|Superiority or Other|||||||0.047||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739437|NCT00448630|3201569|Superiority or Other||||||<|0.001||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739438|NCT00448630|3201569|Superiority or Other||||||<|0.009||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739439|NCT00448630|3201569|Superiority or Other||||||<|0.001||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739440|NCT00448630|3201569|Superiority or Other||||||<|0.005||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739441|NCT00448630|3201569|Superiority or Other||||||<|0.001||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739442|NCT00448630|3201569|Superiority or Other||||||<|0.524||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739443|NCT00448630|3201570|Superiority or Other||||||<|0.001||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time (Baseline, 1 month, 4 months).|
1739444|NCT00448630|3201571|Superiority or Other|||||||0.176||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time (Baseline, 1 month, 4 months).|
1739445|NCT00448630|3201572|Superiority or Other|||||||0.362||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time (Baseline, 1 month, 4 months).|
1739446|NCT00448630|3201573|Superiority or Other|||||||0.245||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time (Baseline, 1 month, 4 months).|
1739447|NCT00448630|3201574|Superiority or Other|||||||0.544||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time (Baseline, 1 month, 4 months).|
1739448|NCT00448630|3201575|Superiority or Other||||||<|0.001||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time (Baseline, 1 month, 4 months).|
1739449|NCT00448630|3201576|Superiority or Other||||||<|0.001||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.|
1739450|NCT00448630|3201577|Superiority or Other|||||||0.8166|||||||Wilcoxon (Mann-Whitney)||||
1739451|NCT00448630|3201577|Superiority or Other|||||||0.0002|||||||Wilcoxon (Mann-Whitney)||||
1739452|NCT00448630|3201577|Superiority or Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)||||
1739453|NCT00448630|3201577|Superiority or Other|||||||0.5224|||||||Wilcoxon (Mann-Whitney)||||
1739454|NCT00448630|3201577|Superiority or Other|||||||0.2502|||||||Wilcoxon (Mann-Whitney)||||
1739455|NCT00448630|3201577|Superiority or Other|||||||1e-06|||||||Wilcoxon (Mann-Whitney)||||
1739456|NCT00448630|3201577|Superiority or Other|||||||0.5774|||||||Wilcoxon (Mann-Whitney)||||
1739457|NCT00448630|3201577|Superiority or Other|||||||0.2237|||||||Wilcoxon (Mann-Whitney)||||
1739458|NCT00448630|3201577|Superiority or Other|||||||0.0024|||||||Wilcoxon (Mann-Whitney)||||
1739459|NCT00448630|3201577|Superiority or Other|||||||0.6813|||||||Wilcoxon (Mann-Whitney)||||
1739460|NCT00448630|3201577|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1739461|NCT00448630|3201577|Superiority or Other|||||||0.7385|||||||Wilcoxon (Mann-Whitney)||||
1739462|NCT00448630|3201577|Superiority or Other|||||||5e-06|||||||Wilcoxon (Mann-Whitney)||||
1739463|NCT00448630|3201577|Superiority or Other|||||||0.2644|||||||Wilcoxon (Mann-Whitney)||||
1739464|NCT00448630|3201577|Superiority or Other|||||||0.1613|||||||Wilcoxon (Mann-Whitney)||||
1739465|NCT00448630|3201577|Superiority or Other|||||||0.0265|||||||Wilcoxon (Mann-Whitney)||||
1739466|NCT00448630|3201577|Superiority or Other|||||||0.0142|||||||Wilcoxon (Mann-Whitney)||||
1739467|NCT00448630|3201577|Superiority or Other|||||||0.0133|||||||Wilcoxon (Mann-Whitney)||||
1739468|NCT00448630|3201577|Superiority or Other|||||||0.0001|||||||Wilcoxon (Mann-Whitney)||||
1739469|NCT00448630|3201577|Superiority or Other|||||||0.0078|||||||Wilcoxon (Mann-Whitney)||||
1739470|NCT00448630|3201577|Superiority or Other|||||||0.0012|||||||Wilcoxon (Mann-Whitney)||||
1739471|NCT00448630|3201577|Superiority or Other|||||||0.05||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739472|NCT00448630|3201577|Superiority or Other||||||<|0.001||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739473|NCT00448630|3201577|Superiority or Other||||||<|0.003||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739474|NCT00448630|3201577|Superiority or Other||||||<|0.001||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739475|NCT00448630|3201577|Superiority or Other||||||<|0.006||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739476|NCT00448630|3201577|Superiority or Other||||||<|0.001||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739477|NCT00448630|3201577|Superiority or Other||||||<|0.49||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||Friedman’s test was used to assess trends over time.|
1739478|NCT00448630|3201578|Superiority or Other||||||<|0.001||||||P-value was not adjusted for multiple comparisons; p-values < 0.05 were considered statistically significant.|Friedman|||We hypothesize that atypical antipsychotic therapy effects the metabolic syndrome parameters, particularly body mass index.|
1739479|NCT00448448|3201586|Superiority or Other (legacy)||Odds Ratio (OR)|1.93|||<|0.0267|2-Sided|95.0|1.08|3.46|||Regression, Logistic|The success rate was adjusted for the propensity score (probability of receiving a brace) and the duration of follow-up.|||
1739480|NCT00448435|3201600|Non-Inferiority or Equivalence|Equivalence margin + or - 15 L/min|Mean Difference (Net)|2.8|Standard Error of the Mean|5.91||0.6383||95.0|-9.1|14.69||Confidence Interval|Mixed Models Analysis|||Difference between treatments [(SLM + FP)- SFC](SE) 2.8 (5.91)|
1739481|NCT00447876|3201674|Superiority or Other (legacy)||||||=|0|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.|
1739482|NCT00447876|3201674|Superiority or Other (legacy)||||||=|0|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.|
1739483|NCT00447876|3201674|Superiority or Other (legacy)||||||=|0|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.|
1739484|NCT00447876|3201674|Superiority or Other (legacy)||||||=|0|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 6. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.|
1739485|NCT00447876|3201674|Superiority or Other (legacy)||||||=|0|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 2. The variables for global assessment of pain assessed by the patient were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.|
1739531|NCT00447278|3201752|Superiority or Other||Least Squares Mean Difference|3.072|||<|0.005|2-Sided|95.0|0.942|5.202||P-value for Total Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739486|NCT00447876|3201675|Superiority or Other (legacy)||||||=|0|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 18. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.|
1739487|NCT00447876|3201675|Superiority or Other (legacy)||||||=|0|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 14. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.|
1739488|NCT00447876|3201675|Superiority or Other (legacy)||||||=|0|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 10. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.|
1739489|NCT00447876|3201675|Superiority or Other (legacy)||||||=|0|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 6. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.|
1739490|NCT00447876|3201675|Superiority or Other (legacy)||||||=|0|||||||Wilcoxon rank sum test|||Dysport® vs placebo at Week 2. The variables for global assessment of pain assessed by the Investigator were described at each visit as ordinal qualitative variables and were compared between the two treatment groups by means of a non parametric Wilcoxon rank sum test.|
1739491|NCT00447876|3201676|Superiority or Other (legacy)||LS mean difference|-0.8|||=|0|2-Sided|95.0|-6.8|5.3||The difference (most affected side – control side) in ROM for the dorsal extension was analyzed using a fixed effect ANCOVA, using Week 18 results as the dependent variable and baseline value as covariate.|ANCOVA||||
1739492|NCT00447876|3201677|Superiority or Other (legacy)||LS mean difference|0.594|||=|0|2-Sided|95.0|-14.575|15.762|||ANCOVA|||The sum of pressure threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.|
1739493|NCT00447876|3201679|Superiority or Other (legacy)||LS mean difference|-8.066|||=|0|2-Sided|95.0|-28.91|12.779|||ANCOVA|||The sum of pain threshold difference (i.e. SPID expressed as AUC) was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID AUC value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.|
1739494|NCT00447876|3201681|Superiority or Other (legacy)||LS mean difference|-4.173|||=|0|2-Sided|95.0|-24.64|16.294|||ANCOVA|||SPID was compared between the two treatment groups using a fixed effect ANCOVA taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.|
1739495|NCT00447876|3201683|Superiority or Other (legacy)||LS mean difference|-8.837|||=|0|2-Sided|95.0|-30.94|13.266|||ANCOVA|||SPID was compared between the two treatment groups using a fixed effect analysis of covariance (ANCOVA) taking into account the SPID value as dependent variable, the baseline pain intensity as co-variable, and the treatment group as explicative variable.|
1739496|NCT00447876|3201685|Superiority or Other (legacy)||||||=|0|||||||Cochran-Mantel-Haenszel|||Gerbershagen’s Global scores were compared at Week 18 using a Cochran-Mantel-Haenszel analysis of variance statistic with adjustment to the baseline score.|
1739497|NCT00447876|3201686|Superiority or Other (legacy)||Treatment difference|0.2|||=|0|2-Sided|95.0|-0.06|0.46|||Fisher Exact|||The responders rate at Week 6 was compared between treatment groups by a two-sided Fisher exact test.|
1739498|NCT00447772|3201695|Superiority or Other (legacy)||Mean difference|-0.322|||=|0|2-Sided|95.0|-0.877|0.233|||ANCOVA||The comparative analysis is based on adjusted means data.|An analysis of covariance (ANCOVA) model included the baseline total Tsui score (patient in sitting position) as covariate and the main type of CD as between-group factor (due to non-significance the interaction between baseline total Tsui score and the main type of CD was removed from the model).|
1739499|NCT00447590|3201705|Superiority or Other||||||<|0.0001|||||||2-sided Exact Binomial Test|||p-Value is from a 2-sided exact binomial test to test the null hypothesis that 30% of subjects have at least 30% EWL.|
1739500|NCT00447382|3201737|Superiority or Other||Treatment Ratio|1.0||||0.966||95.0|0.87|1.15|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data)|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.|
1739501|NCT00447382|3201738|Superiority or Other||Treatment Ratio|0.93||||0.15||95.0|0.84|1.03|||ANOVA|Adjustments:Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data)|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA. The analysis was based on an assumption of a log-normal distribution for antibody data and was thus built on log-transformed data.|
1739502|NCT00447382|3201740|Superiority or Other||Estimated treatment difference|-0.1||||0.812||95.0|-0.89|0.7|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as covariate.|The estimated treatment difference calculated is the NN729-NN304 treatment difference for the change from baseline to Week 52. The 95% confidence interval for this difference was also calculated|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.|
1739503|NCT00447382|3201741|Superiority or Other||Estimated treatment difference|-0.03||||0.758||95.0|-0.21|0.15|||ANOVA|Adjustments: Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as covariate.|The estimated treatment difference calculated is the NN729-NN304 treatment difference for the change from baseline to Week 52. The 95% confidence interval for this difference was also calculated.|The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA.|
1739504|NCT00447382|3201743|Superiority or Other||Treatment Ratio|1.04||||0.649||95.0|0.86|1.26|||ANOVA|Treatment, previous insulin detemir exposure and country as fixed effects and the baseline value as a covariate. (Log transformed data).|The treatment ratio calculated is the NN729-NN304 ratio for the change from baseline to Week 52. The 95% confidence interval for this ratio was also calculated.|"Null hypothesis:Treatment with detemir produced with the NN729 process result in a similar change in cross reacting antibody levels as the NN304 process. Alternative hypothesis: change in antibody levels differ after treatment with detemir produced by the two manufacturing processes.~The statistical analysis applies to the change from baseline to week 52 which was analysed using ANOVA."|
1739505|NCT00447278|3201749|Superiority or Other||Least Squares Mean Difference|-2.34||||0.11|2-Sided|95.0|-5.21|0.54||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739506|NCT00447278|3201749|Superiority or Other||Least Squares Mean Difference|0.3||||0.833|2-Sided|95.0|-2.49|3.08||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739507|NCT00447278|3201749|Superiority or Other||Least Squares Mean Difference|-1.98||||0.106|2-Sided|95.0|-4.4|0.44||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739508|NCT00447278|3201749|Superiority or Other||Least Squares Mean Difference|-0.7||||0.54|2-Sided|95.0|-2.98|1.58||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739509|NCT00447278|3201749|Superiority or Other||Least Squares Mean Difference|-2.26||||0.161|2-Sided|95.0|-5.45|0.92||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739510|NCT00447278|3201749|Superiority or Other||Least Squares Mean Difference|-0.3||||0.854|2-Sided|95.0|-3.59|2.98||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739511|NCT00447278|3201749|Superiority or Other||Least Squares Mean Difference|-3.2||||0.038|2-Sided|95.0|-6.22|-0.19||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739512|NCT00447278|3201749|Superiority or Other||Least Squares Mean Difference|-0.19||||0.895|2-Sided|95.0|-3.01|2.64||P-value for Statisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739513|NCT00447278|3201749|Superiority or Other||Least Squares Mean Difference|0.38||||0.848|2-Sided|95.0|-3.6|4.36||P-value for Achievement Change at 6 Month LOCF. Achievement was derived from the academic achievement subdomain only.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739514|NCT00447278|3201749|Superiority or Other||Least Squares Mean Difference|2.39||||0.263|2-Sided|95.0|-1.83|6.6||P-value for Achievement Change at 4 Month LOCF. Achievement was derived from the academic achievement subdomain only.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739515|NCT00447278|3201750|Superiority or Other||Least Squares Mean Difference|-3.12||||0.004|2-Sided|95.0|-5.26|-0.98||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739516|NCT00447278|3201750|Superiority or Other||Least Squares Mean Difference|-2.62||||0.015|2-Sided|95.0|-4.71|-0.52||P-value for Satisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739517|NCT00447278|3201750|Superiority or Other||Least Squares Mean Difference|-2.78||||0.003|2-Sided|95.0|-4.58|-0.98||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739518|NCT00447278|3201750|Superiority or Other||Least Squares Mean Difference|-1.4||||0.149|2-Sided|95.0|-3.31|0.5||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739519|NCT00447278|3201750|Superiority or Other||Least Squares Mean Difference|0.16||||0.88|2-Sided|95.0|-1.96|2.29||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739520|NCT00447278|3201750|Superiority or Other||Least Squares Mean Difference|0.5||||0.623|2-Sided|95.0|-1.5|2.5||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739521|NCT00447278|3201750|Superiority or Other||Least Squares Mean Difference|-2.5||||0.003|2-Sided|95.0|-4.12|-0.88||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739522|NCT00447278|3201750|Superiority or Other||Least Squares Mean Difference|-1.74||||0.033|2-Sided|95.0|-3.33|-0.14||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739523|NCT00447278|3201750|Superiority or Other||Least Squares Mean Difference|-3.71||||0.003|2-Sided|95.0|-6.16|-1.26||P-value for Achievement Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739524|NCT00447278|3201750|Superiority or Other||Least Squares Mean Difference|-2.35||||0.054|2-Sided|95.0|-4.74|0.04||P-value for Achievement Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739525|NCT00447278|3201751|Superiority or Other||Least Squares Mean Difference|0.169||||0.165|2-Sided|95.0|-0.07|0.407||P-value for Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739526|NCT00447278|3201751|Superiority or Other||Least Squares Mean Difference|0.104||||0.366|2-Sided|95.0|-0.122|0.329||P-value for Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739527|NCT00447278|3201752|Superiority or Other||Least Squares Mean Difference|0.865||||0.119|2-Sided|95.0|-0.225|1.956||P-value for Hyperactivity Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739528|NCT00447278|3201752|Superiority or Other||Least Squares Mean Difference|0.58||||0.298|2-Sided|95.0|-0.515|1.676||P-value for Hyperactivity Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739529|NCT00447278|3201752|Superiority or Other||Least Squares Mean Difference|2.269|||<|0.001|2-Sided|95.0|1.086|3.453||P-value for Inattention Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739530|NCT00447278|3201752|Superiority or Other||Least Squares Mean Difference|1.721|||<|0.004|2-Sided|95.0|0.544|2.899||P-value for Inattention Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739564|NCT00446992|3201798|Superiority or Other||||||=|0|||||||Univariate linear regression|||Baseline compared to Week 16|
1739532|NCT00447278|3201752|Superiority or Other||Least Squares Mean Difference|2.307|||<|0.034|2-Sided|95.0|0.173|4.44||P-value for Total Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739533|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.048||||0.271|2-Sided|95.0|-0.038|0.134||P-value for Social Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739534|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.085||||0.042|2-Sided|95.0|0.003|0.166||p-value for Social Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739535|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.119||||0.04|2-Sided|95.0|0.005|0.233||P-value for Self-Concept Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739536|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.125||||0.034|2-Sided|95.0|0.009|0.24||P-value for Self-Concept Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739537|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.15|||<|0.001|2-Sided|95.0|0.064|0.236||P-value for School Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739538|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.121|||<|0.006|2-Sided|95.0|0.034|0.208||P-value for School Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739539|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.028|||<|0.212|2-Sided|95.0|-0.016|0.073||P-value for Risk Taking Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739540|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.04|||<|0.068|2-Sided|95.0|-0.003|0.084||P-value for Risk Taking Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739541|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.072|||<|0.046|2-Sided|95.0|0.001|0.143||P-value for Daily Living Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739542|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.052|||<|0.156|2-Sided|95.0|-0.02|0.124||P-value for Daily Living Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739543|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.075|||<|0.131|2-Sided|95.0|-0.022|0.172||P-value for Home Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739544|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.094|||<|0.063|2-Sided|95.0|-0.005|0.192||P-value for Home Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739545|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.085|||<|0.004|2-Sided|95.0|0.027|0.143||P-value for Total Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739546|NCT00447278|3201753|Superiority or Other||Least Squares Mean Difference|0.073|||<|0.015|2-Sided|95.0|0.014|0.131||P-value for Total Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739547|NCT00447278|3201754|Superiority or Other||Least Squares Mean Difference|-2.91||||0.027|2-Sided|95.0|-5.49|-0.33||P-value for Satisfaction Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739548|NCT00447278|3201754|Superiority or Other||Least Squares Mean Difference|-3.56||||0.006|2-Sided|95.0|-6.09|-1.04||P-value for Satisfaction Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739549|NCT00447278|3201754|Superiority or Other||Least Squares Mean Difference|-2.29||||0.059|2-Sided|95.0|-4.66|0.09||P-value for Risk Avoidance Change: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739550|NCT00447278|3201754|Superiority or Other||Least Squares Mean Difference|-1.05||||0.388|2-Sided|95.0|-3.44|1.34||P-value for Risk Avoidance Change: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739551|NCT00447278|3201754|Superiority or Other||Least Squares Mean Difference|-0.96||||0.421|2-Sided|95.0|-3.3|1.38||P-value for Resilience Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739552|NCT00447278|3201754|Superiority or Other||Least Squares Mean Difference|0.55||||0.629|2-Sided|95.0|-1.68|2.77||P-value for Resilience Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739553|NCT00447278|3201754|Superiority or Other||Least Squares Mean Difference|-2.1||||0.031|2-Sided|95.0|-4.01|-0.2||P-value for Comfort Change at 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739554|NCT00447278|3201754|Superiority or Other||Least Squares Mean Difference|-3.04||||0.002|2-Sided|95.0|-4.92|-1.15||P-value for Comfort Change at 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739555|NCT00447278|3201755|Superiority or Other||Least Squares Mean Difference|-3.1||||0.002|2-Sided|95.0|-5.08|-1.13||P-value for Change from Baseline: 4 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739556|NCT00447278|3201756|Superiority or Other||Least Squares Mean Difference|-4.6|||<|0.001|2-Sided|95.0|-6.56|-2.63||P-value for Change from Baseline: 6 Month LOCF.|ANCOVA||Least Squares Mean Difference = Atomoxetine minus OEST.||
1739557|NCT00447278|3201756|Superiority or Other||Least Squares Mean Difference|-4.36|||<|0.001|2-Sided|95.0|-6.47|-2.25||P-value for Change from Baseline at 6 Months. P-value is not adjusted and the threshold is 0.05.|Mixed Models Analysis|Mixed model repeated measure analysis with terms for corresponding baseline T-score, treatment, country, visit, and treatment-by-visit interaction.|Least Squares Mean Difference = Atomoxetine minus OEST.||
1739558|NCT00447083|3201776|Other|||||||0.1811|||||||t-test, 2 sided||||
1739559|NCT00447057|3201782|Superiority or Other||Hazard Ratio (HR)|0.68||||0.019|2-Sided|95.0|0.465|0.981||1-sided significance level of 0.20|Log Rank||||
1739560|NCT00447057|3201783|Superiority or Other||Hazard Ratio (HR)|0.64||||0.0034|2-Sided|95.0|0.457|0.887||1-sided significance level of 0.20|Log Rank||||
1739561|NCT00447057|3201784|Superiority or Other|||||||0.1808|||||||Fisher Exact||||
1739562|NCT00447057|3201785|Superiority or Other|||||||0.3909|||||||Fisher Exact||||
1739563|NCT00447057|3201786|Superiority or Other||Hazard Ratio (HR)|0.63||||0.0047|2-Sided|95.0|0.438|0.897|||Log Rank|Log-rank test with 1-sided alpha of 0.20|||
1743521|NCT00413283|3206868|Superiority or Other|||||||1|||||||Fisher Exact||||
1739570|NCT00446992|3201804|Superiority or Other||||||=|0|||||||Univariate linear regression|||Baseline compared to Week 16|
1739571|NCT00446992|3201805|Superiority or Other|||||||0.043|||||||Univariate linear regression|||Baseline compared to Week 16|
1739572|NCT00446992|3201806|Superiority or Other||||||<|0.001|||||||Univariate linear regression|||Baseline compared to Week 16|
1739573|NCT00446966|3201807|Superiority||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1739574|NCT00446797|3201814|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.2||0.738||95.0|-0.3|0.47||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739575|NCT00446797|3201814|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.24||0.889||95.0|-0.43|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739576|NCT00446797|3201814|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.25||0.887||95.0|-0.54|0.45||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739577|NCT00446797|3201815|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.23||0.837||95.0|-0.37|0.52||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739578|NCT00446797|3201815|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.28||0.816||95.0|-0.53|0.58||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739579|NCT00446797|3201815|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.34||0.404||95.0|-0.92|0.42||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739580|NCT00446797|3201816|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.21||0.542||95.0|-0.3|0.53||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739581|NCT00446797|3201816|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.27||0.828||95.0|-0.57|0.49||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739582|NCT00446797|3201816|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.31||0.842||95.0|-0.65|0.59||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739583|NCT00446797|3201817|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.19||0.952||95.0|-0.36|0.39||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739584|NCT00446797|3201817|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.26||0.654||95.0|-0.62|0.38||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739585|NCT00446797|3201817|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.31||0.944||95.0|-0.63|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739586|NCT00446797|3201818|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.27||0.844||95.0|-0.47|0.61||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739587|NCT00446797|3201818|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.34||0.972||95.0|-0.69|0.65||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739588|NCT00446797|3201818|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Deviation|0.32||0.779||95.0|-0.53|0.75||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739589|NCT00446797|3201819|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.24||0.993||95.0|-0.44|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739590|NCT00446797|3201819|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.3||0.712||95.0|-0.5|0.71||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739591|NCT00446797|3201819|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.31||0.929||95.0|-0.59|0.62||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739592|NCT00446797|3201820|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.24||0.655||95.0|-0.33|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739593|NCT00446797|3201820|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.29||0.898||95.0|-0.62|0.51||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739594|NCT00446797|3201820|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.34||0.924||95.0|-0.75|0.58||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739595|NCT00446797|3201821|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.24||0.541||95.0|-0.3|0.62||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739596|NCT00446797|3201821|Superiority or Other||Mean Difference (Final Values)|0.41|Standard Error of the Mean|0.31||0.172||95.0|-0.19|1.02||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739597|NCT00446797|3201821|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.3||0.954||95.0|-0.64|0.53||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739598|NCT00446797|3201822|Superiority or Other||Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.16||0.07||95.0|0.01|0.65||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739599|NCT00446797|3201822|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.18||0.027||95.0|0.05|0.75||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739600|NCT00446797|3201822|Superiority or Other||Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.2||0.229||95.0|-0.17|0.6||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739601|NCT00446797|3201823|Superiority or Other||Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.17||0.117||95.0|-0.01|0.66||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739602|NCT00446797|3201823|Superiority or Other||Mean Difference (Final Values)|0.34|Standard Error of the Mean|0.2||0.108||95.0|-0.05|0.74||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739603|NCT00446797|3201823|Superiority or Other||Mean Difference (Final Values)|0.58|Standard Error of the Mean|0.24||0.017||95.0|0.11|1.05||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739604|NCT00446797|3201824|Superiority or Other||Mean Difference (Final Values)|0.34|Standard Error of the Mean|0.17||0.074||95.0|-0.01|0.68||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739605|NCT00446797|3201824|Superiority or Other||Mean Difference (Final Values)|0.36|Standard Error of the Mean|0.19||0.064||95.0|-0.01|0.73||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739606|NCT00446797|3201824|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.21||0.705||95.0|-0.36|0.47||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739607|NCT00446797|3201825|Superiority or Other||Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.15||0.062||95.0|0.03|0.61||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739608|NCT00446797|3201825|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Deviation|0.18||0.124||95.0|-0.07|0.63||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739609|NCT00446797|3201825|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.21||0.604||95.0|-0.32|0.49||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739610|NCT00446797|3201826|Superiority or Other||Mean Difference (Final Values)|0.35|Standard Error of the Mean|0.22||0.122||95.0|-0.08|0.77||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739611|NCT00446797|3201826|Superiority or Other||Mean Difference (Final Values)|0.61|Standard Error of the Mean|0.22||0.004||95.0|0.18|1.04||Overall p value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739612|NCT00446797|3201826|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.24||0.395||95.0|-0.33|0.62||Overall p-value|ANCOVA|Terms for treatment and country|Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739613|NCT00446797|3201827|Superiority or Other|||||||0.1216||||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 7|
1739614|NCT00446797|3201827|Superiority or Other|||||||0.3041||||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 3|
1739615|NCT00446797|3201827|Superiority or Other|||||||0.0846||||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 2|
1739616|NCT00446797|3201828|Superiority or Other|||||||0.1206||||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 7|
1739617|NCT00446797|3201828|Superiority or Other|||||||0.0157||||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 3|
1739618|NCT00446797|3201828|Superiority or Other|||||||0.29||||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 2|
1739619|NCT00446797|3201829|Superiority or Other|||||||0.0541||||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 7|
1739620|NCT00446797|3201829|Superiority or Other|||||||0.7223||||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|"Controlled for country~Test of row mean score differences based on modified ridits (standardizing the mid-rank)"||Day 3|
1739621|NCT00446797|3201830|Superiority or Other|||||||0.044||||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 7|
1739622|NCT00446797|3201830|Superiority or Other|||||||0.1163||||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 3|
1739623|NCT00446797|3201830|Superiority or Other|||||||0.2411||||||Threshold for statistical significance: p value is less than or equal to 0.05|Cochran-Mantel-Haenszel|Controlled for country Test of row mean score differences based on modified ridits (standardizing the mid-rank)||Day 2|
1739624|NCT00446797|3201831|Superiority or Other|||||||0.6805||||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 7|
1739625|NCT00446797|3201831|Superiority or Other|||||||0.3995||||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 3|
1739626|NCT00446797|3201831|Superiority or Other|||||||0.1591||||||Threshold for statistical significance: p value is less than or equal to 0.05|Regression, Logistic|Terms for treatment and the baseline pain VAS score||Day 2|
1739627|NCT00446797|3201832|Superiority or Other||Mean Difference (Final Values)|2.76|Standard Error of the Mean|1.86||||95.0|-0.91|6.42|||||Direction: nsNSAIDs minus celecoxib|Day 7 Least squares mean|
1739628|NCT00446797|3201832|Superiority or Other||Mean Difference (Final Values)|3.46|Standard Error of the Mean|2.04||||95.0|-0.55|7.48|||||Direction: nsNSAIDs minus celecoxib|Day 3 Least squares mean|
1739629|NCT00446797|3201832|Superiority or Other||Mean Difference (Final Values)|3.1|Standard Error of the Mean|2.02||||95.0|-0.89|7.08|||||Direction: nsNSAIDs minus celecoxib|Day 2 Least squares mean|
1739630|NCT00446797|3201833|Non-Inferiority or Equivalence|To conclude non inferiority, the lower bound of the 2-sided 95% confidence interval of the difference in change scores between the 2 treatment groups (nsNSAIDs - celecoxib) must be greater than –10 mm.|Mean Difference (Final Values)|3.39|Standard Error of the Mean|2.11||||95.0|-0.76|7.55|||||Direction: nsNSAIDs minus celecoxib|Least squares mean|
1739631|NCT00446641|3201843|Superiority or Other||Odds Ratio (OR)|0.82||||0.654||95.0|||||Chi-squared|||We assumed that the prevalence of AR would be 12 % among ischemic stroke patients who were treated with aspirin 100 per day. The prevalence could be reduced to 4% with additional cilostazol therapy|
1739632|NCT00446199|3201889|Superiority or Other||Mean Difference (Final Values)|-0.204||||0.0233||95.0|-0.381|-0.028||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between E2 (0.3) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.|
1739633|NCT00446199|3201889|Superiority or Other||Mean Difference (Final Values)|-0.382|||<|0.0001||95.0|-0.56|-0.205||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.|
1739634|NCT00446199|3201889|Superiority or Other||Mean Difference (Final Values)|-0.635|||<|0.0001||95.0|-0.813|-0.458||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|Treatment, Center, and Baseline value used as covariate||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.|
1739635|NCT00446199|3201890|Superiority or Other||Mean Difference (Final Values)|-0.361||||0.0007||95.0|-0.57|-0.152||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.|
1739636|NCT00446199|3201890|Superiority or Other||Mean Difference (Final Values)|-0.803|||<|0.0001||95.0|-1.013|-0.593||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.|
1739637|NCT00446199|3201890|Superiority or Other||Mean Difference (Final Values)|-1.069|||<|0.0001||95.0|-1.28|-0.859||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.|
1739638|NCT00446199|3201891|Superiority or Other||Mean Difference (Final Values)|-8.6||||0.0054||95.0|-14.6|-2.5||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.|
1739639|NCT00446199|3201891|Superiority or Other||Mean Difference (Final Values)|-14.2|||<|0.0001||95.0|-20.2|-8.1||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.|
1739640|NCT00446199|3201891|Superiority or Other||Mean Difference (Final Values)|-23.9|||<|0.0001||95.0|-29.9|17.8||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 4 is identical in both arms, alternative: there is a difference in the mean change from baseline.|
1739641|NCT00446199|3201892|Superiority or Other||Mean Difference (Final Values)|-9.8||||0.0007||95.0|-15.4|-4.2||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline|
1739686|NCT00446134|3201910|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Deviation|5.0||0.9999|2-Sided|95.0|-15.71|14.11|||Fisher Exact||||
1739642|NCT00446199|3201892|Superiority or Other||Mean Difference (Final Values)|-22.2|||<|0.0001||95.0|-27.8|-16.6||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.|
1739643|NCT00446199|3201892|Superiority or Other||Mean Difference (Final Values)|-27.6|||<|0.0001||95.0|-33.2|-22.0||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|ANCOVA|treatment, center and baseline value used as covariate|Change in active treatment arm minus change in placebo arm|Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The mean change from baseline to week 12 is identical in both arms, alternative: there is a difference in the mean change from baseline.|
1739644|NCT00446199|3201893|Superiority or Other|||||||0.8307|||||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo|
1739645|NCT00446199|3201893|Superiority or Other|||||||0.7749|||||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo|
1739646|NCT00446199|3201893|Superiority or Other|||||||0.2179|||||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo|
1739647|NCT00446199|3201894|Superiority or Other|||||||0.55|||||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo|
1739648|NCT00446199|3201894|Superiority or Other|||||||0.5589|||||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo|
1739649|NCT00446199|3201894|Superiority or Other|||||||0.0144|||||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo|
1739650|NCT00446199|3201895|Superiority or Other|||||||0.4408|||||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo|
1739651|NCT00446199|3201895|Superiority or Other|||||||0.6011|||||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo|
1739652|NCT00446199|3201895|Superiority or Other|||||||0.1067|||||||Cochran-Mantel-Haenszel|Stratification for center||Comparison of active treatment arm with placebo|
1739653|NCT00446199|3201896|Superiority or Other|||||||0.8751|||||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739654|NCT00446199|3201896|Superiority or Other|||||||0.7512|||||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739655|NCT00446199|3201896|Superiority or Other|||||||0.8966||||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739656|NCT00446199|3201897|Superiority or Other|||||||0.4395|||||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739657|NCT00446199|3201897|Superiority or Other|||||||0.1743|||||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739658|NCT00446199|3201897|Superiority or Other|||||||0.9555||||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739659|NCT00446199|3201898|Superiority or Other|||||||0.325|||||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739660|NCT00446199|3201898|Superiority or Other|||||||0.0132|||||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739661|NCT00446199|3201898|Superiority or Other|||||||0.4397||||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739662|NCT00446199|3201899|Superiority or Other|||||||0.0303|||||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739663|NCT00446199|3201899|Superiority or Other|||||||0.4463|||||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739664|NCT00446199|3201899|Superiority or Other|||||||0.0027||||||no correction for multiplicity|Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739665|NCT00446199|3201900|Superiority or Other|||||||0.5908|||||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739666|NCT00446199|3201900|Superiority or Other|||||||0.878|||||||Cochran-Mantel-Haenszel|Stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739667|NCT00446199|3201900|Superiority or Other|||||||0.0314||||||no correction for multiplicity|Cochran-Mantel-Haenszel|stratification by center||Comparison of active treatment arm with placebo on complete 2*4 table|
1739668|NCT00446199|3201901|Superiority or Other||||||<|0.0001|||||||Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.|
1739669|NCT00446199|3201901|Superiority or Other||||||<|0.0001|||||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.|
1739670|NCT00446199|3201901|Superiority or Other||||||<|0.0001|||||||Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal maturation value is identical in both arms, alternative: there is a shift in the distribution.|
1739687|NCT00446134|3201910|Superiority or Other||Mean Difference (Final Values)|0.42|Standard Deviation|5.0||0.9999|2-Sided|95.0|-14.76|15.59|||Fisher Exact||||
1739671|NCT00446199|3201902|Superiority or Other||||||<|0.0001|||||||Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3 mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.|
1739672|NCT00446199|3201902|Superiority or Other||||||<|0.0001|||||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.|
1739673|NCT00446199|3201902|Superiority or Other||||||<|0.0001|||||||Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in vaginal pH is identical in both arms, alternative: there is a shift in the distribution.|
1739674|NCT00446199|3201903|Superiority or Other|||||||0.0005||||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.|
1739675|NCT00446199|3201903|Superiority or Other||||||<|0.0001||||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.|
1739676|NCT00446199|3201903|Superiority or Other||||||<|0.0001||||||Significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|Stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.|
1739677|NCT00446199|3201904|Superiority or Other|||||||0.0096||||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.|
1739678|NCT00446199|3201904|Superiority or Other||||||<|0.0001||||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.|
1739679|NCT00446199|3201904|Superiority or Other||||||<|0.0001||||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the mean daily severity of hot flushes is identical in both arms, alternative: there is a shift in the distribution.|
1739680|NCT00446199|3201905|Superiority or Other||||||<|0.0001||||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.|
1739681|NCT00446199|3201905|Superiority or Other||||||<|0.0001||||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.|
1739682|NCT00446199|3201905|Superiority or Other||||||<|0.0001||||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/ van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 4 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.|
1739683|NCT00446199|3201906|Superiority or Other|||||||0.0005||||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between E2 (0.3mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.|
1739684|NCT00446199|3201906|Superiority or Other||||||<|0.0001||||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.25mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.|
1739685|NCT00446199|3201906|Superiority or Other||||||<|0.0001||||||significance level of 1.7% is used to adjust (Bonferroni) for the comparison of three active arms with Placebo.|Wilcoxon/van Elteren|stratification by center||Comparison between DRSP/E2 (0.5mg/0.5mg) and Placebo with respect to a shift in the distribution of the end point. Null hypothesis: The distribution of the change from baseline to week 12 in the number of hot flushes is identical in both arms, alternative: there is a shift in the distribution.|
1743522|NCT00413283|3206869|Superiority or Other|||||||0.312|||||||Satterthwaite t-test||||
1739688|NCT00446134|3201910|Superiority or Other||Mean Difference (Final Values)|1.22|Standard Deviation|5.0||0.9999|2-Sided|95.0|-13.78|16.22|||Fisher Exact||||
1739689|NCT00446134|3201910|Superiority or Other||Mean Difference (Final Values)|0.8|Standard Deviation|5.0||0.9999|2-Sided|95.0|-14.11|15.71|||Fisher Exact||||
1739690|NCT00446134|3201910|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Deviation|5.0||0.9999|2-Sided|95.0|-14.73|14.73|||Fisher Exact||||
1739691|NCT00446134|3201910|Superiority or Other||Mean Difference (Final Values)|1.22|Standard Deviation|5.0||0.9999|2-Sided|95.0|-13.78|16.22|||Fisher Exact||||
1739692|NCT00446134|3201911|Superiority or Other||Mean Difference (Final Values)|4.9|Standard Deviation|5.0||0.5816|2-Sided|95.0|-10.41|20.24|||Chi-squared||||
1739693|NCT00446134|3201911|Superiority or Other||Mean Difference (Final Values)|17.1|Standard Deviation|5.0||0.0293|2-Sided|95.0|3.22|31.06|||Chi-squared||||
1739694|NCT00446134|3201911|Superiority or Other||Mean Difference (Final Values)|16.4|Standard Deviation|5.0||0.0304|2-Sided|95.0|2.31|30.57|||Chi-squared||||
1739695|NCT00446134|3201912|Non-Inferiority or Equivalence|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|2.73|Standard Deviation|5.0||0.864|2-Sided|95.0|-13.84|19.3|||Fisher Exact||||
1739696|NCT00446134|3201912|Non-Inferiority or Equivalence|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|9.77|Standard Deviation|5.0||0.295|2-Sided|95.0|-6.72|26.26|||Fisher Exact||||
1739697|NCT00446134|3201912|Non-Inferiority or Equivalence|The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.|Difference of Proportion|7.04|Standard Deviation|5.0||0.485|2-Sided|95.0|-9.28|23.35|||Fisher Exact||||
1739698|NCT00446134|3201912|Non-Inferiority or Equivalence|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Difference of Proportion|2.98|Standard Deviation|5.0||0.736|2-Sided|95.0|-13.67|19.63|||Fisher Exact||||
1739699|NCT00446134|3201912|Non-Inferiority or Equivalence|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Difference of Proportion|5.71|Standard Deviation|5.0||0.611|2-Sided|95.0|-10.76|22.19|||Fisher Exact||||
1739700|NCT00446134|3201912|Non-Inferiority or Equivalence|The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.|Other|12.75|Standard Deviation|5.0||0.167|2-Sided|95.0|-3.65|29.15|||Fisher Exact||||
1739701|NCT00445848|3201932|Other||proportion of participants|0.43|||||2-Sided|95.0|0.32|0.53||||||The overall survival rate at year 3 was estimated using Kaplan-Meier.|
1739702|NCT00445848|3201932|Other||proportion of participants|0.57|||||2-Sided|95.0|0.46|0.67||||||The overall survival rate at year 2 was estimated using Kaplan-Meier.|
1739703|NCT00445848|3201932|Other||proportion of participants|0.78|||||2-Sided|95.0|0.67|0.85||||||The overall survival rate at year 1 was estimated using Kaplan-Meier.|
1739704|NCT00445770|3201934|Superiority or Other|||||||0.0948|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52|
1739705|NCT00445770|3201934|Superiority or Other|||||||0.013|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52|
1739706|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 52|
1739707|NCT00445770|3201934|Superiority or Other||||||<|0.1615|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48|
1739708|NCT00445770|3201934|Superiority or Other||||||<|0.0061|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48|
1739709|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 48|
1739710|NCT00445770|3201934|Superiority or Other||||||<|0.418|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40|
1739711|NCT00445770|3201934|Superiority or Other||||||<|0.0002|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40|
1739712|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 40|
1739713|NCT00445770|3201934|Superiority or Other||||||<|0.0807|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32|
1739714|NCT00445770|3201934|Superiority or Other||||||<|0.0004|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32|
1739715|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 32|
1739716|NCT00445770|3201934|Superiority or Other||||||<|0.1279|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24|
1739717|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24|
1739718|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 24|
1739719|NCT00445770|3201934|Superiority or Other||||||<|0.0781|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20|
1739720|NCT00445770|3201934|Superiority or Other||||||<|0.0019|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20|
1739721|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 20|
1739722|NCT00445770|3201934|Superiority or Other||||||<|0.0313|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16|
1739723|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16|
1739724|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 16|
1739725|NCT00445770|3201934|Superiority or Other||||||<|0.0452|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12|
1739726|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12|
1739727|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 12|
1739728|NCT00445770|3201934|Superiority or Other||||||<|0.0293|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8|
1739729|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8|
1739730|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 8|
1739731|NCT00445770|3201934|Superiority or Other||||||<|0.0344|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4|
1739732|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4|
1739733|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 4|
1739734|NCT00445770|3201934|Superiority or Other||||||<|0.0274||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.|ANCOVA|||Week 2|
1739735|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior MTX use + treatment.||Week 2|
1739736|NCT00445770|3201934|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior Methotrexate use + treatment.||Week 2|
1739737|NCT00445770|3201935|Superiority or Other|||||||0.174|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52|
1739738|NCT00445770|3201935|Superiority or Other|||||||0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52|
1739739|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52|
1739740|NCT00445770|3201935|Superiority or Other||||||<|0.0979|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48|
1739741|NCT00445770|3201935|Superiority or Other||||||<|0.0006|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48|
1739742|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48|
1739743|NCT00445770|3201935|Superiority or Other||||||<|0.1488|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40|
1739744|NCT00445770|3201935|Superiority or Other||||||<|0.0003|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40|
1739745|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40|
1739746|NCT00445770|3201935|Superiority or Other||||||<|0.0886|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32|
1739747|NCT00445770|3201935|Superiority or Other||||||<|0.0002|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32|
1739748|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32|
1739749|NCT00445770|3201935|Superiority or Other||||||<|0.0815|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24|
1739750|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24|
1739751|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24|
1739752|NCT00445770|3201935|Superiority or Other||||||<|0.014|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20|
1739753|NCT00445770|3201935|Superiority or Other||||||<|0.007|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20|
1739754|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20|
1739755|NCT00445770|3201935|Superiority or Other||||||<|0.1521|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16|
1739756|NCT00445770|3201935|Superiority or Other||||||<|0.001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16|
1739757|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16|
1739758|NCT00445770|3201935|Superiority or Other||||||<|0.1242|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12|
1739759|NCT00445770|3201935|Superiority or Other||||||<|0.0006|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12|
1739760|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12|
1739761|NCT00445770|3201935|Superiority or Other||||||<|0.0966|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8|
1739762|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8|
1739763|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8|
1739764|NCT00445770|3201935|Superiority or Other||||||<|0.0681|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4|
1739765|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4|
1739766|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4|
1739767|NCT00445770|3201935|Superiority or Other||||||<|0.0442|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2|
1739768|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2|
1739769|NCT00445770|3201935|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment||Week 2|
1739770|NCT00445770|3201936|Superiority or Other|||||||0.1049||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1739771|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1739772|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1739773|NCT00445770|3201936|Superiority or Other||||||<|0.1663||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1739774|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1739775|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1739776|NCT00445770|3201936|Superiority or Other||||||<|0.4437||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1739777|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1739778|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1739779|NCT00445770|3201936|Superiority or Other||||||<|0.0965||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1739780|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1739781|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1739782|NCT00445770|3201936|Superiority or Other||||||<|0.2635||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1739783|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1739784|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1739785|NCT00445770|3201936|Superiority or Other||||||<|0.1636||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1739786|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1739787|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1739788|NCT00445770|3201936|Superiority or Other||||||<|0.4006||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1739789|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1739790|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1739791|NCT00445770|3201936|Superiority or Other||||||<|0.4654||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1739792|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1739793|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1739794|NCT00445770|3201936|Superiority or Other||||||<|0.1214||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1739795|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1739796|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1739797|NCT00445770|3201936|Superiority or Other||||||<|0.4698||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1739798|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1739799|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1739800|NCT00445770|3201936|Superiority or Other||||||<|0.6417||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1739801|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1739802|NCT00445770|3201936|Superiority or Other||||||<|0.0001||||||p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1739803|NCT00445770|3201937|Superiority or Other|||||||0.1734|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52|
1739804|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52|
1739805|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52|
1739806|NCT00445770|3201937|Superiority or Other||||||<|0.1354|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48|
1739807|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48|
1739808|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48|
1739809|NCT00445770|3201937|Superiority or Other||||||<|0.5061|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40|
1739810|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40|
1739811|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40|
1739812|NCT00445770|3201937|Superiority or Other||||||<|0.123|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32|
1739813|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32|
1739814|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32|
1739815|NCT00445770|3201937|Superiority or Other||||||<|0.2786|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24|
1739816|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24|
1739817|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24|
1739818|NCT00445770|3201937|Superiority or Other||||||<|0.4511|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20|
1739819|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20|
1739820|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20|
1739821|NCT00445770|3201937|Superiority or Other||||||<|0.6877|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16|
1739822|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16|
1739823|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16|
1739824|NCT00445770|3201937|Superiority or Other||||||<|0.8905|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12|
1739825|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12|
1739826|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12|
1739827|NCT00445770|3201937|Superiority or Other||||||<|0.4139|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8|
1739828|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8|
1739829|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8|
1739830|NCT00445770|3201937|Superiority or Other||||||<|0.9693|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4|
1739831|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4|
1739832|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4|
1739833|NCT00445770|3201937|Superiority or Other||||||<|0.4929|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2|
1739834|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2|
1739835|NCT00445770|3201937|Superiority or Other||||||<|0.0001|||||||ANCOVA|p-Values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2|
1739836|NCT00445770|3201938|Superiority or Other|||||||0.616|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52|
1739837|NCT00445770|3201938|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52|
1739838|NCT00445770|3201938|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52|
1739839|NCT00445770|3201938|Superiority or Other||||||<|0.6772|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48|
1739840|NCT00445770|3201938|Superiority or Other||||||<|0.0003|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48|
1739841|NCT00445770|3201938|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48|
1739842|NCT00445770|3201938|Superiority or Other||||||<|0.2233|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40|
1739843|NCT00445770|3201938|Superiority or Other||||||<|0.0002|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40|
1739844|NCT00445770|3201938|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40|
1739845|NCT00445770|3201938|Superiority or Other||||||<|0.4652|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32|
1739846|NCT00445770|3201938|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32|
1739847|NCT00445770|3201938|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32|
1739848|NCT00445770|3201938|Superiority or Other||||||<|0.6294|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24|
1739849|NCT00445770|3201938|Superiority or Other||||||<|0.0004|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24|
1739850|NCT00445770|3201938|Superiority or Other||||||<|0.0005|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24|
1739851|NCT00445770|3201938|Superiority or Other||||||<|0.6552|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20|
1739852|NCT00445770|3201938|Superiority or Other||||||<|0.0015|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20|
1739853|NCT00445770|3201938|Superiority or Other||||||<|0.0013|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20|
1739854|NCT00445770|3201938|Superiority or Other||||||<|0.7426|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16|
1739855|NCT00445770|3201938|Superiority or Other||||||<|0.0326|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16|
1739856|NCT00445770|3201938|Superiority or Other||||||<|0.0093|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16|
1739857|NCT00445770|3201938|Superiority or Other||||||<|0.1957|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12|
1739858|NCT00445770|3201938|Superiority or Other||||||<|0.0007|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12|
1739859|NCT00445770|3201938|Superiority or Other||||||<|0.0841|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12|
1739860|NCT00445770|3201938|Superiority or Other||||||<|0.4629|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8|
1739861|NCT00445770|3201938|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8|
1739862|NCT00445770|3201938|Superiority or Other||||||<|0.0026|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8|
1739863|NCT00445770|3201938|Superiority or Other||||||<|0.6348|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4|
1739864|NCT00445770|3201938|Superiority or Other||||||<|0.0007|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4|
1739865|NCT00445770|3201938|Superiority or Other||||||<|0.0009|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4|
1739866|NCT00445770|3201938|Superiority or Other||||||<|0.8928|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2|
1739867|NCT00445770|3201938|Superiority or Other||||||<|0.0035|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2|
1739868|NCT00445770|3201938|Superiority or Other||||||<|0.0162|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2|
1739869|NCT00445770|3201939|Superiority or Other|||||||0.5512|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52|
1739870|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52|
1739871|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52|
1739872|NCT00445770|3201939|Superiority or Other||||||<|0.7226|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48|
1739873|NCT00445770|3201939|Superiority or Other||||||<|0.0002|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48|
1739874|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48|
1739875|NCT00445770|3201939|Superiority or Other||||||<|0.9349|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40|
1739876|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40|
1739877|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40|
1739878|NCT00445770|3201939|Superiority or Other||||||<|0.9719|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32|
1739879|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32|
1739880|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32|
1739881|NCT00445770|3201939|Superiority or Other||||||<|0.7236|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24|
1739882|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24|
1739883|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24|
1739884|NCT00445770|3201939|Superiority or Other||||||<|0.7229|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20|
1739885|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20|
1739886|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20|
1739887|NCT00445770|3201939|Superiority or Other||||||<|0.3978|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16|
1739888|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16|
1739889|NCT00445770|3201939|Superiority or Other||||||<|0.0003|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16|
1739890|NCT00445770|3201939|Superiority or Other||||||<|0.568|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12|
1739891|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12|
1739892|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12|
1739893|NCT00445770|3201939|Superiority or Other||||||<|0.7378|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8|
1739894|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8|
1739895|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8|
1739896|NCT00445770|3201939|Superiority or Other||||||<|0.3947|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4|
1739897|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4|
1739898|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4|
1739899|NCT00445770|3201939|Superiority or Other||||||<|0.4376|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2|
1739900|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2|
1739901|NCT00445770|3201939|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2|
1739902|NCT00445770|3201940|Superiority or Other|||||||0.4749|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52|
1739903|NCT00445770|3201940|Superiority or Other|||||||0.0035|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52|
1739904|NCT00445770|3201940|Superiority or Other|||||||0.0007|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 52|
1739905|NCT00445770|3201940|Superiority or Other|||||||0.3564|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48|
1739906|NCT00445770|3201940|Superiority or Other|||||||0.0004|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48|
1739907|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 48|
1739908|NCT00445770|3201940|Superiority or Other||||||<|0.6267|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40|
1739909|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40|
1739910|NCT00445770|3201940|Superiority or Other||||||<|0.0008|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 40|
1739911|NCT00445770|3201940|Superiority or Other||||||<|0.4358|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32|
1739912|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32|
1739913|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 32|
1739914|NCT00445770|3201940|Superiority or Other||||||<|0.7618|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24|
1739915|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24|
1739916|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 24|
1743523|NCT00413283|3206869|Superiority or Other|||||||0.725|||||||Satterthwaite t-test||||
1739917|NCT00445770|3201940|Superiority or Other||||||<|0.3671|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20|
1739918|NCT00445770|3201940|Superiority or Other||||||<|0.0002|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20|
1739919|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 20|
1739920|NCT00445770|3201940|Superiority or Other||||||<|0.6112|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16|
1739921|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16|
1739922|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 16|
1739923|NCT00445770|3201940|Superiority or Other||||||<|0.0848|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12|
1739924|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12|
1739925|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 12|
1739926|NCT00445770|3201940|Superiority or Other||||||<|0.7953|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8|
1739927|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8|
1739928|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 8|
1739929|NCT00445770|3201940|Superiority or Other||||||<|0.4653|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4|
1739930|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4|
1739931|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 4|
1739932|NCT00445770|3201940|Superiority or Other||||||<|0.4751|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2|
1739933|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2|
1739934|NCT00445770|3201940|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by pooled study center and prior methotrexate use||Week 2|
1739935|NCT00445770|3201941|Superiority or Other|||||||0.2326|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52|
1739936|NCT00445770|3201941|Superiority or Other|||||||0.004|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52|
1739937|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 52|
1739938|NCT00445770|3201941|Superiority or Other||||||<|0.2589|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48|
1739939|NCT00445770|3201941|Superiority or Other||||||<|0.0018|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48|
1739940|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 48|
1739941|NCT00445770|3201941|Superiority or Other||||||<|0.1059|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40|
1739942|NCT00445770|3201941|Superiority or Other||||||<|0.0048|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40|
1739943|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 40|
1739944|NCT00445770|3201941|Superiority or Other||||||<|0.1903|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32|
1739945|NCT00445770|3201941|Superiority or Other||||||<|0.0008|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32|
1739946|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 32|
1739947|NCT00445770|3201941|Superiority or Other||||||<|0.0789|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24|
1739948|NCT00445770|3201941|Superiority or Other||||||<|0.0036|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24|
1739949|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 24|
1739950|NCT00445770|3201941|Superiority or Other||||||<|0.0201|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20|
1739951|NCT00445770|3201941|Superiority or Other||||||<|0.0147|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20|
1739952|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 20|
1739953|NCT00445770|3201941|Superiority or Other||||||<|0.2221|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16|
1739954|NCT00445770|3201941|Superiority or Other||||||<|0.0007|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16|
1739955|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 16|
1739956|NCT00445770|3201941|Superiority or Other||||||<|0.2883|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12|
1739957|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12|
1739958|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 12|
1739959|NCT00445770|3201941|Superiority or Other||||||<|0.1851|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8|
1739960|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8|
1739961|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 8|
1739962|NCT00445770|3201941|Superiority or Other||||||<|0.0144|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4|
1739963|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4|
1739964|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 4|
1739965|NCT00445770|3201941|Superiority or Other||||||<|0.1053|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2|
1739966|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2|
1739967|NCT00445770|3201941|Superiority or Other||||||<|0.0001|||||||ANCOVA|P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.||Week 2|
1739968|NCT00445770|3201942|Superiority or Other|||||||0.7973||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1739969|NCT00445770|3201942|Superiority or Other|||||||0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1739970|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1739971|NCT00445770|3201942|Superiority or Other||||||<|0.7073||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1739972|NCT00445770|3201942|Superiority or Other||||||<|0.0002||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1739973|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1739974|NCT00445770|3201942|Superiority or Other||||||<|0.7663||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1739975|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1739976|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1739977|NCT00445770|3201942|Superiority or Other||||||<|0.6713||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1739978|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1739979|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1739980|NCT00445770|3201942|Superiority or Other||||||<|0.5727||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1739981|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1739982|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1739983|NCT00445770|3201942|Superiority or Other||||||<|0.5004||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1739984|NCT00445770|3201942|Superiority or Other||||||<|0.0003||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1739985|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1739986|NCT00445770|3201942|Superiority or Other||||||<|0.729||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1739987|NCT00445770|3201942|Superiority or Other||||||<|0.0004||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1739988|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1739989|NCT00445770|3201942|Superiority or Other||||||<|0.9749||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1739990|NCT00445770|3201942|Superiority or Other||||||<|0.0002||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1739991|NCT00445770|3201942|Superiority or Other||||||<|0.0002||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1739992|NCT00445770|3201942|Superiority or Other||||||<|0.5612||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1739993|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1739994|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1739995|NCT00445770|3201942|Superiority or Other||||||<|0.4652||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1739996|NCT00445770|3201942|Superiority or Other||||||<|0.0003||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1739997|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1739998|NCT00445770|3201942|Superiority or Other||||||<|0.8044||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1739999|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740000|NCT00445770|3201942|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740001|NCT00445770|3201943|Superiority or Other|||||||0.9313||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740002|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740003|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740004|NCT00445770|3201943|Superiority or Other||||||<|0.5343||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740005|NCT00445770|3201943|Superiority or Other||||||<|0.0003||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740006|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740007|NCT00445770|3201943|Superiority or Other||||||<|0.7826||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740008|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740009|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740010|NCT00445770|3201943|Superiority or Other||||||<|0.8894||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740011|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740012|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740013|NCT00445770|3201943|Superiority or Other||||||<|0.6563||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740014|NCT00445770|3201943|Superiority or Other||||||<|0.0002||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740015|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740016|NCT00445770|3201943|Superiority or Other||||||<|0.3302||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740017|NCT00445770|3201943|Superiority or Other||||||<|0.0011||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740018|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740019|NCT00445770|3201943|Superiority or Other||||||<|0.318||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740020|NCT00445770|3201943|Superiority or Other||||||<|0.0007||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740021|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740022|NCT00445770|3201943|Superiority or Other||||||<|0.8982||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740023|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740024|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740025|NCT00445770|3201943|Superiority or Other||||||<|0.9324||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740026|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740027|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740028|NCT00445770|3201943|Superiority or Other||||||<|0.3736||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740029|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740030|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740031|NCT00445770|3201943|Superiority or Other||||||<|0.8972||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740032|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740033|NCT00445770|3201943|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740034|NCT00445770|3201944|Superiority or Other|||||||0.1649||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740035|NCT00445770|3201944|Superiority or Other|||||||0.2112||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740036|NCT00445770|3201944|Superiority or Other|||||||0.0095||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740037|NCT00445770|3201944|Superiority or Other|||||||0.592||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740038|NCT00445770|3201944|Superiority or Other|||||||0.0645||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740039|NCT00445770|3201944|Superiority or Other|||||||0.0187||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740040|NCT00445770|3201944|Superiority or Other|||||||0.9955||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740041|NCT00445770|3201944|Superiority or Other|||||||0.0346||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740042|NCT00445770|3201944|Superiority or Other|||||||0.0371||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740043|NCT00445770|3201944|Superiority or Other|||||||0.5919||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740044|NCT00445770|3201944|Superiority or Other|||||||0.029||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740045|NCT00445770|3201944|Superiority or Other|||||||0.0073||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740046|NCT00445770|3201944|Superiority or Other|||||||0.6642||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740047|NCT00445770|3201944|Superiority or Other|||||||0.0181||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740048|NCT00445770|3201944|Superiority or Other|||||||0.0554||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740049|NCT00445770|3201944|Superiority or Other|||||||0.9762||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740050|NCT00445770|3201944|Superiority or Other|||||||0.006||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740051|NCT00445770|3201944|Superiority or Other|||||||0.006||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740052|NCT00445770|3201944|Superiority or Other|||||||0.9713||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740053|NCT00445770|3201944|Superiority or Other|||||||0.0029||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740054|NCT00445770|3201944|Superiority or Other|||||||0.0036||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740055|NCT00445770|3201944|Superiority or Other|||||||0.6427||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740056|NCT00445770|3201944|Superiority or Other|||||||0.0061||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740057|NCT00445770|3201944|Superiority or Other|||||||0.0235||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740058|NCT00445770|3201944|Superiority or Other|||||||0.7271||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740059|NCT00445770|3201944|Superiority or Other|||||||0.0005||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740060|NCT00445770|3201944|Superiority or Other|||||||0.002||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740061|NCT00445770|3201944|Superiority or Other|||||||0.9694||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740062|NCT00445770|3201944|Superiority or Other|||||||0.0011||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740063|NCT00445770|3201944|Superiority or Other|||||||0.0015||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740064|NCT00445770|3201944|Superiority or Other|||||||0.8875||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740065|NCT00445770|3201944|Superiority or Other|||||||0.0015||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740066|NCT00445770|3201944|Superiority or Other|||||||0.0027||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740067|NCT00445770|3201945|Superiority or Other|||||||0.9371||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740068|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740069|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740070|NCT00445770|3201945|Superiority or Other||||||<|0.5277||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740071|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740072|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740073|NCT00445770|3201945|Superiority or Other||||||<|0.8047||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740074|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740075|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740076|NCT00445770|3201945|Superiority or Other||||||<|0.3704||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740077|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740078|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740079|NCT00445770|3201945|Superiority or Other||||||<|0.2179||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740080|NCT00445770|3201945|Superiority or Other||||||<|0.0005||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740081|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740082|NCT00445770|3201945|Superiority or Other||||||<|0.2936||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740083|NCT00445770|3201945|Superiority or Other||||||<|0.0004||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740084|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740085|NCT00445770|3201945|Superiority or Other||||||<|0.6574||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740086|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740087|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740088|NCT00445770|3201945|Superiority or Other||||||<|0.7146||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740089|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740090|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740091|NCT00445770|3201945|Superiority or Other||||||<|0.9241||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740092|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740093|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740094|NCT00445770|3201945|Superiority or Other||||||<|0.568||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740095|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740096|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740097|NCT00445770|3201945|Superiority or Other||||||<|0.7488||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740098|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740099|NCT00445770|3201945|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740100|NCT00445770|3201946|Superiority or Other|||||||0.0453||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740101|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740102|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740103|NCT00445770|3201946|Superiority or Other||||||<|0.0271||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740104|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740105|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740106|NCT00445770|3201946|Superiority or Other||||||<|0.0729||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740107|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740108|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740109|NCT00445770|3201946|Superiority or Other||||||<|0.0291||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740110|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740111|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740112|NCT00445770|3201946|Superiority or Other||||||<|0.128||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740113|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740114|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740115|NCT00445770|3201946|Superiority or Other||||||<|0.1078||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740116|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740117|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740118|NCT00445770|3201946|Superiority or Other||||||<|0.5216||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740119|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740120|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740121|NCT00445770|3201946|Superiority or Other||||||<|0.7529||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740122|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740123|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740124|NCT00445770|3201946|Superiority or Other||||||<|0.3473||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740125|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740126|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740127|NCT00445770|3201946|Superiority or Other||||||<|0.7407||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740128|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740129|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740130|NCT00445770|3201946|Superiority or Other||||||<|0.6337||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740131|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740132|NCT00445770|3201946|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740133|NCT00445770|3201947|Superiority or Other|||||||0.0168||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740134|NCT00445770|3201947|Superiority or Other|||||||0.079||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740135|NCT00445770|3201947|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740136|NCT00445770|3201947|Superiority or Other||||||<|0.0214||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740137|NCT00445770|3201947|Superiority or Other||||||<|0.1179||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740138|NCT00445770|3201947|Superiority or Other||||||<|0.0002||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740139|NCT00445770|3201947|Superiority or Other||||||<|0.2351||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740140|NCT00445770|3201947|Superiority or Other||||||<|0.0101||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740141|NCT00445770|3201947|Superiority or Other||||||<|0.0002||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740142|NCT00445770|3201947|Superiority or Other||||||<|0.0461||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740143|NCT00445770|3201947|Superiority or Other||||||<|0.005||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740144|NCT00445770|3201947|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740145|NCT00445770|3201947|Superiority or Other||||||<|0.2075||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740146|NCT00445770|3201947|Superiority or Other||||||<|0.0003||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740147|NCT00445770|3201947|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740148|NCT00445770|3201947|Superiority or Other||||||<|0.2257||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740149|NCT00445770|3201947|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740150|NCT00445770|3201947|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740151|NCT00445770|3201947|Superiority or Other||||||<|0.5882||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740152|NCT00445770|3201947|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740153|NCT00445770|3201947|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740154|NCT00445770|3201947|Superiority or Other||||||<|0.2412||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740155|NCT00445770|3201947|Superiority or Other||||||<|0.0016||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740156|NCT00445770|3201947|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740157|NCT00445770|3201947|Superiority or Other||||||<|0.1606||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740158|NCT00445770|3201947|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740159|NCT00445770|3201947|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740160|NCT00445770|3201947|Superiority or Other||||||<|0.5738||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740161|NCT00445770|3201947|Superiority or Other||||||<|0.0002||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740162|NCT00445770|3201947|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740163|NCT00445770|3201947|Superiority or Other||||||<|0.4237||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740164|NCT00445770|3201947|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740165|NCT00445770|3201947|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740166|NCT00445770|3201948|Superiority or Other|||||||0.1158||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740167|NCT00445770|3201948|Superiority or Other|||||||0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740168|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 52|
1740169|NCT00445770|3201948|Superiority or Other||||||<|0.2616||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740170|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740171|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 48|
1740172|NCT00445770|3201948|Superiority or Other||||||<|0.6731||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740173|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740174|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 40|
1740175|NCT00445770|3201948|Superiority or Other||||||<|0.8611||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740176|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740177|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 32|
1740178|NCT00445770|3201948|Superiority or Other||||||<|0.7439||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740179|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740180|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 24|
1740181|NCT00445770|3201948|Superiority or Other||||||<|0.9357||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740182|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740183|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 20|
1740184|NCT00445770|3201948|Superiority or Other||||||<|0.4663||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740185|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740186|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 16|
1740187|NCT00445770|3201948|Superiority or Other||||||<|0.4948||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740188|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740189|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 12|
1740190|NCT00445770|3201948|Superiority or Other||||||<|0.5495||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740191|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740192|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 8|
1740193|NCT00445770|3201948|Superiority or Other||||||<|0.8037||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740194|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740195|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 4|
1740196|NCT00445770|3201948|Superiority or Other||||||<|0.1224||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740197|NCT00445770|3201948|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740198|NCT00445770|3201948|Superiority or Other||||||<|0.0032||||||P-values from ANCOVA model: change = baseline + pooled study center + prior methotrexate use + treatment.|ANCOVA|||Week 2|
1740199|NCT00445770|3201949|Superiority or Other|||||||0.0433||||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression <=SDD|
1740200|NCT00445770|3201949|Superiority or Other|||||||0.0285||||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression <=SDD|
1740201|NCT00445770|3201949|Superiority or Other|||||||0.001||||||Stratified by pooled study center and prior methotrexate use.|Cochran-Mantel-Haenszel|||Week 52 for progression <=SDD|
1740202|NCT00445770|3201949|Superiority or Other|||||||0.312||||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression <=3.0|
1740203|NCT00445770|3201949|Superiority or Other|||||||0.0002||||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression <=3.0|
1740204|NCT00445770|3201949|Superiority or Other|||||||0.0001||||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression <=3.0|
1740205|NCT00445770|3201949|Superiority or Other|||||||0.3022||||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression <=0.5|
1740206|NCT00445770|3201949|Superiority or Other|||||||0.0002||||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression <=0.5|
1740207|NCT00445770|3201949|Superiority or Other||||||<|0.0001||||||Stratified by pooled study center and prior methotrexate use|Cochran-Mantel-Haenszel|||Week 52 for progression <=0.5|
1740208|NCT00445770|3201950|Superiority or Other|||||||0.1123||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52|
1740209|NCT00445770|3201950|Superiority or Other|||||||0.0006||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52|
1740210|NCT00445770|3201950|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52|
1740211|NCT00445770|3201950|Superiority or Other||||||<|0.0186||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24|
1740212|NCT00445770|3201950|Superiority or Other||||||<|0.0013||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24|
1740213|NCT00445770|3201950|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24|
1740214|NCT00445770|3201951|Superiority or Other|||||||0.5717||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52|
1740215|NCT00445770|3201951|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52|
1740216|NCT00445770|3201951|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 52|
1740217|NCT00445770|3201951|Superiority or Other||||||<|0.726||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24|
1740218|NCT00445770|3201951|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24|
1740219|NCT00445770|3201951|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA|||Week 24|
1740220|NCT00445770|3201952|Superiority or Other|||||||0.2248||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA||||
1740221|NCT00445770|3201952|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA||||
1740222|NCT00445770|3201952|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA||||
1740223|NCT00445770|3201953|Non-Inferiority or Equivalence|An outcome showing that etanercept 10 mg was superior to methotrexate and the presence of numerical difference ≤0.5 mTSS units between etanercept 25 mg and etanercept 10 mg would support non-inferiority for the 2 etanercept treatments.||||||0.2634||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA||||
1740224|NCT00445770|3201953|Superiority or Other||||||<|0.0001||||||P-values from ANCOVA model based on rank transformed data: rank of change = rank baseline + treatment + pooled study center + prior methotrexate use.|ANCOVA||||
1740225|NCT00445770|3201953|Superiority or Other||||||<|0.0001||||||Based on rank transformed data: rank of change = rank baseline+treatment +pooled study center+prior methotrexate use. If overall treatment effect statistically significant, 3 pairwise comparisons conducted, otherwise no further testing was made.|ANCOVA|||It was estimated that with 180 participants per group, there would be 81% power for the overall test. With this sample size and 0.05 (2-sided) type I error, there was 88% power to detect a 1.33 difference for the change of mTSS from baseline to 52 weeks between the etanercept 25 mg twice weekly group and Methotrexate group, assuming that the common standard deviation of the change of mTSS from baseline was 4.|
1740226|NCT00445679|3201967|Superiority or Other|||||||0.85|||||||Cochran-Mantel-Haenszel|||Final on-therapy population|
1740227|NCT00445679|3201967|Superiority or Other|||||||0.452|||||||Cochran-Mantel-Haenszel|||Final on-therapy population|
1740228|NCT00445679|3201967|Superiority or Other|||||||0.45|||||||Cochran-Mantel-Haenszel|||Final on-therapy population|
1740229|NCT00445679|3201968|Superiority or Other|||||||0.881|||||||Cochran-Mantel-Haenszel|||Final on-therapy population|
1740230|NCT00445679|3201968|Superiority or Other|||||||0.653|||||||Cochran-Mantel-Haenszel|||Final on-therapy population|
1740231|NCT00445679|3201968|Superiority or Other|||||||0.714|||||||Cochran-Mantel-Haenszel|||Final on-therapy population|
1740232|NCT00445679|3201969|Non-Inferiority or Equivalence|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|-2.17|||||2-Sided|95.0|-11.68|7.33|||||||
1740233|NCT00445679|3201969|Non-Inferiority or Equivalence|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|0.88|||||2-Sided|95.0|-8.5|10.25|||||||
1740234|NCT00445679|3201969|Non-Inferiority or Equivalence|Noninferiority to paroxetine was declared if the lower limit of the 95% two-sided confidence interval for the difference in responders is greater than or equal to -9 percentage points.|Difference|-3.13|||||2-Sided|95.0|-12.62|6.37|||||||
1740235|NCT00445601|3201972|Superiority||Hazard Ratio (HR)|0.51||||0.23|2-Sided|95.0|0.18|1.49|||Log Rank||||
1740236|NCT00445601|3201973|Superiority||Hazard Ratio (HR)|0.66||||0.01|2-Sided|95.0|0.48|0.9|||Log Rank||||
1740237|NCT00445588|3201975|Superiority or Other||Hazard Ratio (HR)|0.85||||0.4|2-Sided|95.0|0.6|1.3||cox regression model was used to estimate the HR of death compared to NABTT historical control with same histology, adjusted for age, KPS, and surgical procedure|Regression, Cox|cox regression model used to estimate the HR of death compared to NABTT historical control same histology, adjusted for age, KPS, surgical procedure||The overall failure rate will be estimated by dividing the number of events (death) with the total exposure time in the study cohort. 95% confidence intervals and median time of survival will be calculated using standard methods.|
1740238|NCT00445328|3202006|Superiority or Other|||||||0.1355|||||||Chi-squared||||
1740239|NCT00445328|3202009|Superiority or Other|||||||1|||||||Chi-squared|||Major Bleeding|
1740240|NCT00445328|3202011|Superiority or Other|||||||1||||||P-value is based on chi-square test with alpha as 0.01.|Chi-squared||||
1740241|NCT00445302|3202035|Superiority or Other||Ratio of least squares means (%)|169.51||||||90.0|129.59|221.72|||||||
1740242|NCT00445302|3202035|Superiority or Other||Ratio of least squares means (%)|151.44||||||90.0|115.78|198.09|||||||
1740243|NCT00445302|3202035|Superiority or Other||Ratio of least squares means (%)|121.74||||||90.0|91.86|161.43|||||||
1740244|NCT00445302|3202038|Superiority or Other||Ratio of least squares means (%)|106.76||||||90.0|79.11|144.08|||||||
1740245|NCT00445302|3202038|Superiority or Other||Ratio of least squares means(%)|106.6||||||90.0|78.99|143.87|||||||
1740246|NCT00445302|3202038|Superiority or Other||Ratio of least squares means (%)|87.09|||||2-Sided|90.0|63.59|119.26|||||||
1740247|NCT00445224|3202043|Superiority or Other|||||||0.049|||||||ANOVA|||Repeated measures ANOVA for group and time|
1740248|NCT00445224|3202044|Superiority or Other|||||||0.041|||||||ANOVA||||
1740249|NCT00445003|3202071|Superiority or Other||Mean Difference (Final Values)|-1.7|||<|0.001|2-Sided|95.0|-2.1|-1.3||adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons||
1740250|NCT00445003|3202071|Superiority or Other||Mean Difference (Final Values)|-0.6|||<|0.001|2-Sided|95.0|-1.0|-0.2||adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons||
1740251|NCT00445003|3202074|Superiority or Other||Mean Difference (Final Values)|1.2||||0.63|2-Sided|95.0|-4.4|6.8||Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons||
1740252|NCT00445003|3202074|Superiority or Other||Mean Difference (Final Values)|1.9||||0.44|2-Sided|95.0|-3.7|7.5||Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons||
1740253|NCT00445003|3202076|Superiority or Other||Mean Difference (Final Values)|-100.0|||<|0.001|2-Sided|95.0|-128.0|-71.0||adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons||
1740254|NCT00445003|3202076|Superiority or Other||Mean Difference (Final Values)|-35.0|||<|0.01|2-Sided|95.0|-64.0|-6.0||Adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes|ANCOVA||adjusted for multiple comparisons||
1740255|NCT00445003|3202078|Superiority or Other||Mean Difference (Final Values)|6.7|||<|0.001|2-Sided|95.0|3.2|10.1||adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes|ANCOVA||adjusted for multiple comparisons||
1740256|NCT00445003|3202078|Superiority or Other||Mean Difference (Final Values)|5.6|||<|0.001|2-Sided|95.0|2.2|9.0||adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes|ANCOVA||adjusted for multiple comparison||
1740257|NCT00444925|3202082|Superiority or Other|||||||0.0153|||||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.|
1740258|NCT00444925|3202082|Superiority or Other|||||||0.0004|||||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 12.|
1740259|NCT00444925|3202082|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 12.|
1740260|NCT00444925|3202082|Superiority or Other||||||<|0.3104|||||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.|
1740261|NCT00444925|3202082|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 4.|
1740262|NCT00444925|3202082|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 4.|
1740263|NCT00444925|3202082|Superiority or Other||||||<|0.7828|||||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.|
1740264|NCT00444925|3202082|Superiority or Other||||||<|0.0116|||||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Tolterodine ER vs placebo at Week 1.|
1740265|NCT00444925|3202082|Superiority or Other||||||<|0.0072|||||||Cochran-Mantel-Haenszel|Stratified by baseline urgency urinary incontinence quartile.||Treatment Difference Fesoterodine vs placebo at Week 1.|
1740266|NCT00444925|3202083|Superiority or Other||Mean Difference (Final Values)|7.3|Standard Error of the Mean|1.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL scale score total.|
1740267|NCT00444925|3202083|Superiority or Other||Mean Difference (Final Values)|4.8|Standard Error of the Mean|1.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL social interaction domain.|
1740268|NCT00444925|3202083|Superiority or Other||Mean Difference (Final Values)|5.0|Standard Deviation|1.5|<|0.0008|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL sleep domain.|
1740269|NCT00444925|3202083|Superiority or Other||Mean Difference (Final Values)|8.6|Standard Error of the Mean|1.6|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL coping domain.|
1740270|NCT00444925|3202083|Superiority or Other||Mean Difference (Final Values)|9.2|Standard Error of the Mean|1.6|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo: HRQL concern domain.|
1743524|NCT00413283|3206869|Superiority or Other|||||||0.972|||||||Satterthwaite t-test||||
1740271|NCT00444925|3202084|Superiority or Other||Mean Difference (Final Values)|-10.8|Standard Error of the Mean|1.5|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment difference Fesoterodine vs placebo at Week 12|
1740272|NCT00444925|3202085|Superiority or Other|||||||0.0008|||||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 12|
1740273|NCT00444925|3202085|Superiority or Other|||||||0.0017|||||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 4|
1740274|NCT00444925|3202085|Superiority or Other|||||||0.0773|||||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 1|
1740275|NCT00444925|3202086|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 12|
1740276|NCT00444925|3202086|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 4|
1740277|NCT00444925|3202086|Superiority or Other||||||<|0.0143|||||||Cochran-Mantel-Haenszel|With modified ridit scoring and stratified by country.||Fesoterodine vs placebo at Week 1|
1740278|NCT00444925|3202087|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.7||0.1047|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.|
1740279|NCT00444925|3202087|Superiority or Other||Mean Difference (Final Values)|-3.8|Standard Error of the Mean|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.|
1740280|NCT00444925|3202087|Superiority or Other||Mean Difference (Final Values)|-4.9|Standard Error of the Mean|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.|
1740281|NCT00444925|3202087|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.6|<|0.2473|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.|
1740282|NCT00444925|3202087|Superiority or Other||Mean Difference (Final Values)|-4.0|Standard Error of the Mean|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.|
1740283|NCT00444925|3202087|Superiority or Other||Mean Difference (Final Values)|-4.7|Standard Error of the Mean|0.8|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.|
1740284|NCT00444925|3202087|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.6|<|0.7288|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.|
1740285|NCT00444925|3202087|Superiority or Other||Mean Difference (Final Values)|-3.3|Standard Error of the Mean|0.7|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.|
1740286|NCT00444925|3202087|Superiority or Other||Mean Difference (Final Values)|-3.1|Standard Error of the Mean|0.7|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.|
1740287|NCT00444925|3202088|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.0||0.0289|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.|
1740288|NCT00444925|3202088|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.|
1740289|NCT00444925|3202088|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.|
1740290|NCT00444925|3202088|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.0|<|0.1267|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.|
1740379|NCT00444600|3202135|Superiority or Other (legacy)|||||||0.03|||||||GEE repeated measures|||P value for comparison with sham|
1740291|NCT00444925|3202088|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.|
1740292|NCT00444925|3202088|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.|
1740293|NCT00444925|3202088|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.0|<|0.5972|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.|
1740294|NCT00444925|3202088|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.|
1740295|NCT00444925|3202088|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.|
1740296|NCT00444925|3202089|Superiority or Other|||||||0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.|
1740297|NCT00444925|3202089|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.|
1740298|NCT00444925|3202089|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.|
1740299|NCT00444925|3202089|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.|
1740300|NCT00444925|3202089|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.|
1740301|NCT00444925|3202089|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.|
1740302|NCT00444925|3202090|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.2||0.1391|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.|
1740303|NCT00444925|3202090|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.2||0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.|
1740380|NCT00444600|3202136|Superiority or Other (legacy)|||||||0.17|||||||GEE repeated measures|||P value for comparison with sham|
1740381|NCT00444600|3202136|Superiority or Other (legacy)|||||||0.08|||||||GEE repeated measures|||P value for comparison with sham|
1740304|NCT00444925|3202090|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.|
1740305|NCT00444925|3202090|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.2|<|0.151|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.|
1740306|NCT00444925|3202090|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.|
1740307|NCT00444925|3202090|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.|
1740308|NCT00444925|3202090|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.2|<|0.5581|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.|
1740309|NCT00444925|3202090|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.|
1740310|NCT00444925|3202090|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.|
1740311|NCT00444925|3202091|Superiority or Other|||||||0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.|
1740312|NCT00444925|3202091|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.|
1740313|NCT00444925|3202091|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.|
1740314|NCT00444925|3202091|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.|
1740315|NCT00444925|3202091|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.|
1740316|NCT00444925|3202091|Superiority or Other||||||<|0.0004||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.|
1740382|NCT00444600|3202146|Superiority or Other (legacy)||Risk Ratio (RR)|1.76|||<|0.001||95.0|1.31|2.36||Confidence intervals adjusted for multiple comparisons.|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser|
1740317|NCT00444925|3202092|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.2||0.0542|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.|
1740318|NCT00444925|3202092|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.|
1740319|NCT00444925|3202092|Superiority or Other||Mean Difference (Final Values)|-1.5|Standard Error of the Mean|0.3|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.|
1740320|NCT00444925|3202092|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.2|<|0.3498|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.|
1740321|NCT00444925|3202092|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.|
1740322|NCT00444925|3202092|Superiority or Other||Mean Difference (Final Values)|-1.4|Standard Error of the Mean|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.|
1740323|NCT00444925|3202092|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.2|<|0.382|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.|
1740324|NCT00444925|3202092|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.|
1740325|NCT00444925|3202092|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.2|<|0.0008|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.|
1740326|NCT00444925|3202094|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.1||0.699|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.|
1740327|NCT00444925|3202094|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.1||0.5059|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.|
1740328|NCT00444925|3202094|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.3269|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.|
1740329|NCT00444925|3202094|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.1||0.7264|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.|
1740330|NCT00444925|3202094|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.1643|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.|
1740331|NCT00444925|3202094|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.2667|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.|
1740332|NCT00444925|3202094|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.1||0.3503|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.|
1740333|NCT00444925|3202094|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.0652|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.|
1743721|NCT00411749|3207149|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1740334|NCT00444925|3202094|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.273|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.|
1740335|NCT00444925|3202095|Superiority or Other|||||||0.0003||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.|
1740336|NCT00444925|3202095|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 12: corresponding numerical change result not statistically significant.|
1740337|NCT00444925|3202095|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.|
1740338|NCT00444925|3202095|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.|
1740339|NCT00444925|3202095|Superiority or Other||||||<|0.0002||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.|
1740340|NCT00444925|3202095|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.|
1740341|NCT00444925|3202096|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1||0.3798|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.|
1740342|NCT00444925|3202096|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.2||0.0005|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.|
1740343|NCT00444925|3202096|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.|
1740344|NCT00444925|3202096|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.1|<|0.4185|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.|
1740345|NCT00444925|3202096|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.2|<|0.0007|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.|
1740346|NCT00444925|3202096|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.2|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.|
1740383|NCT00444600|3202146|Superiority or Other (legacy)||Risk Ratio (RR)|1.55|||<|0.001|2-Sided|95.0|1.13|2.13||Confidence intervals adjusted for multiple comparisons|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser|
1740347|NCT00444925|3202096|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.1|<|0.7395|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.|
1740348|NCT00444925|3202096|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.2|<|0.0006|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.|
1740349|NCT00444925|3202096|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.2|<|0.0002|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.|
1740350|NCT00444925|3202097|Superiority or Other||Mean Difference (Final Values)|9.4|Standard Error of the Mean|3.3||0.0048|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.|
1740351|NCT00444925|3202097|Superiority or Other||Mean Difference (Final Values)|6.7|Standard Error of the Mean|4.1||0.1029|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 12.|
1740352|NCT00444925|3202097|Superiority or Other||Mean Difference (Final Values)|16.1|Standard Error of the Mean|4.1|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 12.|
1740353|NCT00444925|3202097|Superiority or Other||Mean Difference (Final Values)|4.7|Standard Error of the Mean|3.3|<|0.1484|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 4.|
1740354|NCT00444925|3202097|Superiority or Other||Mean Difference (Final Values)|11.7|Standard Error of the Mean|4.0|<|0.0036|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 4.|
1740355|NCT00444925|3202097|Superiority or Other||Mean Difference (Final Values)|16.5|Standard Error of the Mean|4.0|<|0.0001|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 4.|
1740356|NCT00444925|3202097|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|2.7|<|0.8659|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs Tolterodine ER at Week 1.|
1740357|NCT00444925|3202097|Superiority or Other||Mean Difference (Final Values)|8.2|Standard Error of the Mean|3.4|<|0.0149|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference LSMean Difference(SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Tolterodine ER vs placebo at Week 1.|
1740358|NCT00444925|3202097|Superiority or Other||Mean Difference (Final Values)|7.8|Standard Error of the Mean|3.4|<|0.0214|||||||ANCOVA|Based on an analysis of covariance model with country and treatment as factors, and centered baseline value as a covariate.|Treatment Difference Least Squares Mean (LSMean) Difference Standard Error (SE), SE is recorded as Parameter Dispersion Type: Standard Error of the mean.|Treatment Difference Fesoterodine vs placebo at Week 1.|
1740359|NCT00444925|3202098|Superiority or Other|||||||0.022||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12.|
1740360|NCT00444925|3202098|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 12.|
1740361|NCT00444925|3202098|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 12.|
1740362|NCT00444925|3202098|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.|
1740363|NCT00444925|3202098|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 4. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 4: corresponding numerical change result not statistically significant.|
1740364|NCT00444925|3202098|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Tolterodine ER vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.|
1740365|NCT00444925|3202098|Superiority or Other||||||<|0.0001||||||Inferential testing: percent change from baseline only carried out for given end/time point if corresponding numeric change result statistically significant (to preserve alpha level at 5% within each type of diary endpoint for a given comparison).|ANCOVA|Based on a ranked analysis of covariance model with country and treatment as factors, and ranked baseline value as a covariate.||Treatment Difference Fesoterodine vs placebo at Week 1. Per closed testing procedure, statistical testing for percent change not performed for Fesoterodine vs Tolterodine ER Week 1: corresponding numerical change result not statistically significant.|
1740366|NCT00444925|3202099|Superiority or Other|||||||0.1937|||||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1740367|NCT00444925|3202099|Superiority or Other||||||<|0.0001|||||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1740368|NCT00444925|3202099|Superiority or Other||||||<|0.0001|||||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs placebo at Week 4. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1740369|NCT00444925|3202099|Superiority or Other||||||<|0.846|||||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1740370|NCT00444925|3202099|Superiority or Other||||||<|0.0001|||||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1740371|NCT00444925|3202099|Superiority or Other||||||<|0.0001|||||||Van Elteren's Test|P-value based on Van Elteren's Test adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs placebo at Week 1. Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1740372|NCT00444925|3202100|Superiority or Other|||||||0.0172||||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine vs Tolterodine ER at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1740373|NCT00444925|3202100|Superiority or Other|||||||0.0107||||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Tolterodine ER vs placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the 5th and 95th percentile, respectively).|
1740374|NCT00444925|3202100|Superiority or Other||||||<|0.0001||||||Comparison fesoterodine vs tolterodine ER performed only if statistical significance favoring fesoterodine achieved for fesoterodine vs placebo to preserve overall alpha level at 5%; pairwise comparison also performed for tolterodine ER vs placebo.|Van Elteren's Test|P-value based on Van Elteren's Test (a stratified Wilcoxon-Mann Whitney test) adjusted by baseline UUI quartile.||Treatment Difference Fesoterodine versus (vs) placebo at Week 12. Treatment effects estimated by Winsorized means (5% of the tails were censored, ie, replaced with the value at the fifth (5th) and ninety-fifth (95th) percentile, respectively).|
1740375|NCT00444600|3202131|Superiority or Other (legacy)||Mean Difference (Net)|-0.62|||<|0.001|2-Sided|95.0|-0.91|-0.34||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser|
1740376|NCT00444600|3202131|Superiority or Other (legacy)||Mean Difference (Net)|-0.68|||<|0.001|2-Sided|95.0|-0.96|-0.41||Confidence intervals adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser|
1740377|NCT00444600|3202131|Superiority or Other (legacy)||Mean Difference (Net)|-0.73|||<|0.001|2-Sided|95.0|-1.01|-0.44||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity and correlation between 2 study eyes.||Difference in mean change from sham+prompt laser|
1740378|NCT00444600|3202135|Superiority or Other (legacy)|||||||0.17|||||||GEE repeated measures|||P value for comparison with sham|
1740384|NCT00444600|3202146|Superiority or Other (legacy)||Risk Ratio (RR)|2.0|||<|0.001|2-Sided|95.0|1.52|2.64||Confidence intervals are adjusted for multiple comparisons.|Regression, Logistic|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for comparison with sham+prompt laser|
1740385|NCT00444600|3202147|Superiority or Other (legacy)||Risk Ratio (RR)|1.02||||0.95|2-Sided|95.0|0.47|2.2|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year|
1740386|NCT00444600|3202147|Superiority or Other (legacy)||Risk Ratio (RR)|0.28||||0.01|2-Sided|95.0|0.08|0.97|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year|
1740387|NCT00444600|3202147|Superiority or Other (legacy)||Risk Ratio (RR)|0.21||||0.009|2-Sided|95.0|0.05|0.87|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter worsening comparison with sham+prompt laser at 1 year|
1740388|NCT00444600|3202147|Superiority or Other (legacy)||Proportion|0.0|||||2-Sided|95.0|-6.0|6.0||||||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year|
1740389|NCT00444600|3202147|Superiority or Other (legacy)||Proportion|-6.0|||||2-Sided|95.0|-10.0|-1.0||||||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year|
1740390|NCT00444600|3202147|Superiority or Other (legacy)||Proportion|-6.0|||||2-Sided|95.0|-11.0|-2.0||||||Difference in proportion with ≥15 letter worsening from sham+prompt laser at 1 year|
1740391|NCT00444600|3202147|Superiority or Other (legacy)||Risk Ratio (RR)|1.43||||0.07|2-Sided|95.0|0.9|2.29||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year|
1740392|NCT00444600|3202147|Superiority or Other (legacy)||Risk Ratio (RR)|1.89|||<|0.001|2-Sided|95.0|1.25|2.87||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year|
1740393|NCT00444600|3202147|Superiority or Other (legacy)||Risk Ratio (RR)|2.09|||<|0.001|2-Sided|95.0|1.35|3.22|||Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥15 letter improvement comparison with sham+prompt laser at 1 year|
1740394|NCT00444600|3202147|Superiority or Other (legacy)||Proportion|6.0|||<||2-Sided|95.0|-2.0|15.0||||||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year|
1740395|NCT00444600|3202147|Superiority or Other (legacy)||Proportion|13.0|||<||2-Sided|95.0|4.0|22.0||||||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year|
1740396|NCT00444600|3202147|Superiority or Other (legacy)||Proportion|16.0|||<||2-Sided|95.0|6.0|26.0||||||Difference in proportion with ≥15 letter improvement from sham+prompt laser at 1 year|
1740397|NCT00444600|3202147|Superiority or Other (legacy)||Risk Ratio (RR)|1.08|||<|0.75|2-Sided|95.0|0.62|1.87||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year|
1740398|NCT00444600|3202147|Superiority or Other (legacy)||Risk Ratio (RR)|0.24|||<|0.001|2-Sided|95.0|0.08|0.68||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year|
1740399|NCT00444600|3202147|Superiority or Other (legacy)||Risk Ratio (RR)|0.24|||<|0.001|2-Sided|95.0|0.09|0.65||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter worsening comparison with sham+prompt laser at 1 year|
1740400|NCT00444600|3202147|Superiority or Other (legacy)||Proportion|1.0|||<||2-Sided|95.0|-7.0|9.0||||||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year|
1740401|NCT00444600|3202147|Superiority or Other (legacy)||Proportion|-10.0|||<||2-Sided|95.0|-16.0|-4.0||||||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year|
1740402|NCT00444600|3202147|Superiority or Other (legacy)||Proportion|-10.0|||<||2-Sided|95.0|-16.0|-5.0||||||Difference in proportion with ≥10 letter worsening from sham+prompt laser at 1 year|
1740403|NCT00444600|3202147|Superiority or Other (legacy)||Risk Ratio (RR)|1.21|||<|0.16|2-Sided|95.0|0.88|1.66||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.|Eyes were analyzed.|Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year|
1740404|NCT00444600|3202147|Superiority or Other (legacy)||Risk Ratio (RR)|1.68|||<|0.001|2-Sided|95.0|1.27|2.21||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year|
1740405|NCT00444600|3202147|Superiority or Other (legacy)||Risk Ratio (RR)|1.84|||<|0.001|2-Sided|95.0|1.4|2.42||Confidence intervals are adjusted for multiple comparisons.|Log-Binomial Regression|Adjusted for correlation between 2 study eyes and multiple comparisons.||Relative risk for ≥10 letter improvement comparison with sham+prompt laser at 1 year|
1740406|NCT00444600|3202147|Superiority or Other (legacy)||Proportion|6.0|||<||2-Sided|95.0|-4.0|16.0||||||Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year|
1740407|NCT00444600|3202147|Superiority or Other (legacy)||Proportion|19.0|||<||2-Sided|95.0|9.0|29.0||||||Difference in proportion with ≥10 letter improvement from sham+prompt laser at 1 year|
1740408|NCT00444600|3202147|Superiority or Other (legacy)||Proportion|23.0|||<||2-Sided|95.0|13.0|34.0||||||Difference in proportion with ≥10 letter improvement for sham+prompt laser at 1 year|
1740409|NCT00444600|3202148|Superiority or Other (legacy)||Mean Difference (Final Values)|1.1||||0.31|2-Sided|95.0|-1.5|3.7||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.|||
1741503|NCT00433654|3203837|Superiority or Other||Percentage|0.0|||<|0.001|1-Sided|95.0||1.7|||exact test of binomial proportions|||Null hypothesis: rate > 10%|
1740410|NCT00444600|3202148|Superiority or Other (legacy)||Mean Difference (Final Values)|6.0|||<|0.001|2-Sided|95.0|3.4|8.6||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.|||
1740411|NCT00444600|3202148|Superiority or Other (legacy)||Mean Difference (Final Values)|5.8|||<|0.001|2-Sided|95.0|3.2|8.5||Adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline visual acuity and correlation between 2 study eyes.|||
1740412|NCT00444600|3202150|Superiority or Other (legacy)||Difference in mean change|-52.0|||<|0.001|2-Sided|95.0|-75.0|-29.0||Confidence interval is adjusted for multiple comparisons|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser|
1740413|NCT00444600|3202150|Superiority or Other (legacy)||Difference in mean change|-49.0|||<|0.001|2-Sided|95.0|-72.0|-26.0||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in optical coherence tomography central subfield thickness mean change from sham+prompt laser|
1740414|NCT00444600|3202150|Superiority or Other (legacy)||Difference in mean change|-55.0|||<|0.001|2-Sided|95.0|-78.0|-32.0||Confidence intervals are adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline retinal thickness and visual acuity and correlation between two study eyes.||Difference in central subfield thickness mean change from sham+prompt laser|
1740415|NCT00444535|3202169|Superiority or Other (legacy)||Exact binomial procedure|69.2||||||95.0|54.9|81.3|||||||
1740416|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.03|||||2-Sided|95.0|-0.15|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A|
1740417|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.02|||||2-Sided|95.0|-0.14|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A|
1740418|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.01|||||2-Sided|95.0|-0.11|0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A|
1740419|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.08|||||2-Sided|95.0|-0.2|0.05|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F|
1740420|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.05|||||2-Sided|95.0|-0.17|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F|
1740421|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.03|||||2-Sided|95.0|-0.1|0.15|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F|
1740422|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.02|||||2-Sided|95.0|-0.1|0.14|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A|
1740423|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.1|||||2-Sided|95.0|-0.02|0.21|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A|
1740424|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.08|||||2-Sided|95.0|-0.04|0.19|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A|
1740425|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.06|||||2-Sided|95.0|-0.17|0.05|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5|
1740426|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.1|||||2-Sided|95.0|0.0|0.21|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5|
1740427|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.17|||||2-Sided|95.0|0.05|0.28|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5|
1740428|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.13|||||2-Sided|95.0|-0.25|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3|
1740429|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.07|||||2-Sided|95.0|-0.18|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3|
1740430|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.06|||||2-Sided|95.0|-0.06|0.18|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3|
1740431|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.02|||||2-Sided|95.0|-0.15|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1|
1740432|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.09|||||2-Sided|95.0|-0.21|0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1|
1740433|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.07|||||2-Sided|95.0|-0.2|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1|
1740434|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.11|||||2-Sided|95.0|-0.03|0.25|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F|
1740435|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.08|||||2-Sided|95.0|-0.07|0.22|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F|
1740436|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.03|||||2-Sided|95.0|-0.17|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F|
1740437|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.33|||||2-Sided|95.0|-0.47|-0.2|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F|
1740438|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.37|||||2-Sided|95.0|-0.51|-0.22|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F|
1740439|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.03|||||2-Sided|95.0|-0.18|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F|
1740440|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.12|||||2-Sided|95.0|-0.25|0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C|
1740441|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.24|||||2-Sided|95.0|-0.37|-0.12|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C|
1740442|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.12|||||2-Sided|95.0|-0.25|0.0|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C|
1740443|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.02|||||2-Sided|95.0|-0.11|0.15|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14|
1740444|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.04|||||2-Sided|95.0|-0.17|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14|
1740445|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.06|||||2-Sided|95.0|-0.19|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14|
1740446|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.02|||||2-Sided|95.0|-0.13|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V|
1740447|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.04|||||2-Sided|95.0|-0.15|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V|
1740448|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.02|||||2-Sided|95.0|-0.13|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V|
1740449|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.06|||||2-Sided|95.0|-0.18|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B|
1740450|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.12|||||2-Sided|95.0|0.0|0.23|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B|
1740451|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.18|||||2-Sided|95.0|0.06|0.3|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B|
1740452|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.31|||||2-Sided|95.0|-0.43|-0.19|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4|
1740453|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|-0.29|||||2-Sided|95.0|-0.41|-0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4|
1740454|NCT00444457|3202178|Superiority or Other||Difference in log-transformed GM|0.02|||||2-Sided|95.0|-0.1|0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4|
1740689|NCT00442546|3202442|Superiority or Other||Mean Difference (Final Values)|0.333|Standard Error of the Mean|0.896||0.7226||95.0|-1.859|2.525|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740455|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||2-Sided|95.0|-1.86|1.05|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A|
1740456|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||2-Sided|95.0|-0.75|1.58|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A|
1740457|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||2-Sided|95.0|-0.45|2.1|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A|
1740458|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.4|||||2-Sided|95.0|-5.11|-0.01|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F|
1740459|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||2-Sided|95.0|-2.67|1.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F|
1740460|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.9|||||2-Sided|95.0|-0.62|4.67|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F|
1740461|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||2-Sided|95.0|-3.0|0.92|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A|
1740462|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||2-Sided|95.0|-1.62|1.71|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A|
1740463|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.9|||||2-Sided|95.0|-0.87|3.02|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A|
1740464|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.6|||||2-Sided|95.0|-6.72|1.4|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5|
1740465|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||2-Sided|95.0|-3.14|4.11|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5|
1740466|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|3.1|||||2-Sided|95.0|-0.84|7.13|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5|
1740467|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-6.5|||||2-Sided|95.0|-13.51|0.54|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3|
1740468|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.8|||||2-Sided|95.0|-11.79|2.16|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3|
1740469|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.6|||||2-Sided|95.0|-5.2|8.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3|
1740470|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.4|||||2-Sided|95.0|-7.45|0.46|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1|
1740471|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.6|||||2-Sided|95.0|-6.39|1.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1|
1740472|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||2-Sided|95.0|-3.34|5.08|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1|
1740473|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.4|||||2-Sided|95.0|-3.06|5.82|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F|
1740474|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.9|||||2-Sided|95.0|-2.38|6.28|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F|
1740475|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||2-Sided|95.0|-3.67|4.8|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F|
1741666|NCT00432809|3203962|Superiority or Other||||||<|0.001|||||||Chi-squared|||Medical Therapy vs. Gastric Bypass|
1740476|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-2.4|||||2-Sided|95.0|-5.44|0.33|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F|
1740477|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.3|||||2-Sided|95.0|-6.35|-0.4|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F|
1740478|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.8|||||2-Sided|95.0|-4.23|2.52|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F|
1740479|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.5|||||2-Sided|95.0|-9.55|0.46|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C|
1740480|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-10.0|||||2-Sided|95.0|-15.31|-4.7|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C|
1740481|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-5.5|||||2-Sided|95.0|-11.17|0.2|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C|
1740482|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||2-Sided|95.0|-1.46|2.59|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14|
1740483|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||2-Sided|95.0|-1.69|2.39|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14|
1740484|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.2|||||2-Sided|95.0|-2.14|1.73|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14|
1740485|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||2-Sided|95.0|-6.3|4.41|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V|
1740486|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.7|||||2-Sided|95.0|-10.24|0.76|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V|
1740487|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-3.8|||||2-Sided|95.0|-9.46|1.82|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V|
1740488|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.6|||||2-Sided|95.0|-2.27|0.75|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B|
1740489|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||2-Sided|95.0|-1.69|1.06|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B|
1740490|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||2-Sided|95.0|-1.19|2.07|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B|
1740491|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-5.2|||||2-Sided|95.0|-9.85|-0.79|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4|
1740492|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-6.7|||||2-Sided|95.0|-11.3|-2.15|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4|
1740493|NCT00444457|3202179|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-1.4|||||2-Sided|95.0|-6.52|3.63|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4|
1740494|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||2-Sided|95.0|-1.09|1.07|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A|
1740495|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||2-Sided|95.0|-1.05|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A|
1740496|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||2-Sided|95.0|-1.04|1.09|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 19A|
1741566|NCT00433290|3203885|Superiority or Other|||||||0.05||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA||||
1740497|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||2-Sided|95.0|-1.59|1.49|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F|
1740498|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||2-Sided|95.0|-0.48|2.0|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F|
1740499|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||2-Sided|95.0|-0.47|2.09|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 7F|
1740500|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||2-Sided|95.0|-0.83|1.56|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A|
1740501|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||2-Sided|95.0|-0.76|1.56|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A|
1740502|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||2-Sided|95.0|-1.04|1.08|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 6A|
1740503|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||2-Sided|95.0|-1.84|1.02|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5|
1740504|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||2-Sided|95.0|-1.27|1.3|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5|
1740505|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||2-Sided|95.0|-1.0|1.84|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 5|
1740506|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-7.7|||||2-Sided|95.0|-13.14|-2.37|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3|
1740507|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-4.9|||||2-Sided|95.0|-9.99|0.21|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3|
1740508|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|2.8|||||2-Sided|95.0|-2.85|8.55|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 3|
1740509|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||2-Sided|95.0|-1.79|1.66|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1|
1740510|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||2-Sided|95.0|-0.2|2.44|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1|
1740511|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.9|||||2-Sided|95.0|-0.17|2.53|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Additional serotypes - serotype 1|
1740512|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.8|||||2-Sided|95.0|-1.05|2.87|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F|
1740513|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|1.1|||||2-Sided|95.0|-0.52|3.16|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F|
1740514|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||2-Sided|95.0|-1.21|2.05|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 23F|
1740515|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.6|||||2-Sided|95.0|-2.44|1.0|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F|
1740516|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-1.1|||||2-Sided|95.0|-3.06|0.57|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F|
1740517|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||2-Sided|95.0|-2.55|1.5|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 19F|
1741567|NCT00433290|3203886|Superiority or Other|||||||0.007||||||P-value for Change from Baseline. Change=Endpoint minus baseline.|ANCOVA||||
1740518|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||2-Sided|95.0|-2.87|0.74|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C|
1740519|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.5|||||2-Sided|95.0|-2.3|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C|
1740520|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.4|||||2-Sided|95.0|-1.52|2.39|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 18C|
1740521|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.3|||||2-Sided|95.0|-1.61|0.76|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14|
1740522|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||2-Sided|95.0|-1.03|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14|
1740523|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.3|||||2-Sided|95.0|-0.74|1.62|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 14|
1740524|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.5|||||2-Sided|95.0|-0.87|2.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V|
1740525|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.6|||||2-Sided|95.0|-0.76|2.18|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V|
1740526|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||2-Sided|95.0|-1.25|1.37|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 9V|
1740527|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||2-Sided|95.0|-1.13|1.06|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B|
1740528|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||2-Sided|95.0|-1.03|1.04|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B|
1740529|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.0|||||2-Sided|95.0|-1.02|1.11|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 6B|
1740530|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.9|||||2-Sided|95.0|-2.54|0.2|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4|
1740531|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|-0.8|||||2-Sided|95.0|-2.39|0.23|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4|
1740532|NCT00444457|3202181|Non-Inferiority or Equivalence|The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.|Difference|0.1|||||2-Sided|95.0|-1.61|1.81|||||Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.|Common serotypes - serotype 4|
1740533|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||2-Sided|95.0|-1.4|2.04||||||Additional serotypes - serotype 19A|
1740534|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||2-Sided|95.0|-2.69|1.19||||||Additional serotypes - serotype 19A|
1740535|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.0|||||2-Sided|95.0|-2.91|0.8||||||Additional serotypes - serotype 19A|
1740536|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||2-Sided|95.0|-2.3|0.52||||||Additional serotypes - serotype 7F|
1740537|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.0|||||2-Sided|95.0|-1.12|1.18||||||Additional serotypes - serotype 7F|
1740538|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||2-Sided|95.0|-0.47|2.3||||||Additional serotypes - serotype 7F|
1740813|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|0.867|Standard Error of the Mean|0.975||0.3805||95.0|-1.116|2.849|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740539|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.7|||||2-Sided|95.0|-5.39|-0.27||||||Additional serotypes - serotype 6A|
1740540|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||2-Sided|95.0|-2.22|1.86||||||Additional serotypes - serotype 6A|
1740541|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.5|||||2-Sided|95.0|0.12|5.23||||||Additional serotypes - serotype 6A|
1740542|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-4.1|||||2-Sided|95.0|-7.92|-0.36||||||Additional serotypes - serotype 5|
1740543|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||2-Sided|95.0|-3.52|3.09||||||Additional serotypes - serotype 5|
1740544|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|3.9|||||2-Sided|95.0|0.15|7.69||||||Additional serotypes - serotype 5|
1740545|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-6.8|||||2-Sided|95.0|-12.76|-0.74||||||Additional serotypes - serotype 3|
1740546|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-10.7|||||2-Sided|95.0|-16.8|-4.57||||||Additional serotypes - serotype 3|
1740547|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-3.9|||||2-Sided|95.0|-10.27|2.45||||||Additional serotypes - serotype 3|
1740548|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.5|||||2-Sided|95.0|-3.77|0.67||||||Additional serotypes - serotype 1|
1740549|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.7|||||2-Sided|95.0|-2.78|1.34||||||Additional serotypes - serotype 1|
1740550|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||2-Sided|95.0|-1.48|3.18||||||Additional serotypes - serotype 1|
1740551|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||2-Sided|95.0|-3.75|5.46||||||Common serotypes - serotype 23F|
1740552|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|4.0|||||2-Sided|95.0|-0.27|8.39||||||Common serotypes - serotype 23F|
1740553|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|3.2|||||2-Sided|95.0|-1.03|7.46||||||Common serotypes - serotype 23F|
1740554|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.8|||||2-Sided|95.0|-3.87|0.02||||||Common serotypes - serotype 19F|
1740555|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.5|||||2-Sided|95.0|-3.46|0.28||||||Common serotypes - serotype 19F|
1740556|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||2-Sided|95.0|-1.93|2.6||||||Common serotypes - serotype 19F|
1740557|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.2|||||2-Sided|95.0|-4.89|0.23||||||Common serotypes - serotype 18C|
1740558|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||2-Sided|95.0|-2.33|1.99||||||Common serotypes - serotype 18C|
1740559|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.1|||||2-Sided|95.0|-0.38|4.74||||||Common serotypes - serotype 18C|
1741628|NCT00432809|3203950|Superiority or Other|||||||0.004|||||||Chi-squared||||
1740560|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.8|||||2-Sided|95.0|-1.04|2.76||||||Common serotypes - serotype 14|
1740561|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|1.1|||||2-Sided|95.0|-0.6|3.01||||||Common serotypes - serotype 14|
1740562|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.3|||||2-Sided|95.0|-1.27|1.95||||||Common serotypes - serotype 14|
1740563|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.9|||||2-Sided|95.0|-3.81|1.88||||||Common serotypes - serotype 9V|
1740564|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-1.1|||||2-Sided|95.0|-3.97|1.73||||||Common serotypes - serotype 9V|
1740565|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.2|||||2-Sided|95.0|-3.13|2.83||||||Common serotypes - serotype 9V|
1740566|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-4.9|||||2-Sided|95.0|-8.82|-1.1||||||Common serotypes - serotype 6B|
1740567|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|0.4|||||2-Sided|95.0|-2.77|3.66||||||Common serotypes - serotype 6B|
1740568|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|5.3|||||2-Sided|95.0|1.55|9.19||||||Common serotypes - serotype 6B|
1740569|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-2.9|||||2-Sided|95.0|-5.58|-0.58||||||Common serotypes - serotype 4|
1740570|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|-0.9|||||2-Sided|95.0|-3.09|1.1||||||Common serotypes - serotype 4|
1740571|NCT00444457|3202182|Non-Inferiority or Equivalence|Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.|Difference|2.0|||||2-Sided|95.0|-0.51|4.75||||||Common serotypes - serotype 4|
1740572|NCT00444457|3202183|Non-Inferiority or Equivalence|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.0|||||2-Sided|95.0|-2.4|2.2|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Hepatitis B: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|
1740573|NCT00444457|3202184|Non-Inferiority or Equivalence|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.5|||||2-Sided|95.0|-1.5|3.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 3: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|
1740574|NCT00444457|3202184|Non-Inferiority or Equivalence|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|-0.6|||||2-Sided|95.0|-3.4|2.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 2: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|
1740575|NCT00444457|3202184|Non-Inferiority or Equivalence|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|0.0|||||2-Sided|95.0|-2.1|2.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Poliovirus type 1: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|
1740576|NCT00444457|3202185|Non-Inferiority or Equivalence|For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.|Difference|-0.1|||||2-Sided|95.0|-3.3|3.0|||||Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|Tetanus toxoid: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.|
1740616|NCT00444106|3202200|Superiority or Other||||||<|0.0001|||||||One-sided exact test for a single propn.|One-sided exact test for a single proportion.||"One-sided null hypothesis that the incidence rate of ABR Wave III latency changes is greater than or equal to 15%.~Increase in ABR Wave III latency between baseline and Day 7 of greater than 0.3 ms."|
1740577|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.06|||||2-Sided|95.0|-0.05|0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A|
1740578|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.02|||||2-Sided|95.0|-0.12|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A|
1740579|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.08|||||2-Sided|95.0|-0.19|0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 19A|
1740580|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||2-Sided|95.0|-0.15|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F|
1740581|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.05|||||2-Sided|95.0|-0.14|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F|
1740582|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.01|||||2-Sided|95.0|-0.09|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 7F|
1740583|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.01|||||2-Sided|95.0|-0.13|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A|
1740584|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.12|||||2-Sided|95.0|0.01|0.24|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A|
1740585|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.14|||||2-Sided|95.0|0.02|0.25|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 6A|
1740586|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.25|||||2-Sided|95.0|-0.37|-0.13|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5|
1740587|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.0|||||2-Sided|95.0|-0.12|0.12|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5|
1740588|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.25|||||2-Sided|95.0|0.13|0.37|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 5|
1740589|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.09|||||2-Sided|95.0|-0.19|0.02|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3|
1740679|NCT00442546|3202440|Superiority or Other|||||||0.3822|||||||Cochran-Mantel-Haenszel|||Month 3|
1740590|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.18|||||2-Sided|95.0|-0.28|-0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3|
1740591|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.09|||||2-Sided|95.0|-0.19|0.02|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 3|
1740592|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.05|||||2-Sided|95.0|-0.17|0.06|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1|
1740593|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.16|||||2-Sided|95.0|-0.28|-0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1|
1740594|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.11|||||2-Sided|95.0|-0.23|0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Additional serotypes - serotype 1|
1740595|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.2|||||2-Sided|95.0|0.07|0.34|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F|
1740596|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.18|||||2-Sided|95.0|0.04|0.31|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F|
1740597|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||2-Sided|95.0|-0.16|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 23F|
1740598|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.22|||||2-Sided|95.0|-0.33|-0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F|
1740599|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.34|||||2-Sided|95.0|-0.44|-0.23|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F|
1740600|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.11|||||2-Sided|95.0|-0.22|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 19F|
1740601|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.1|||||2-Sided|95.0|-0.2|0.0|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C|
1740602|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.13|||||2-Sided|95.0|-0.23|-0.03|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C|
1740680|NCT00442546|3202440|Superiority or Other|||||||0.1509|||||||Cochran-Mantel-Haenszel|||Month 3|
1740681|NCT00442546|3202441|Superiority or Other|||||||0.5202|||||||Cochran-Mantel-Haenszel|||Week 6/ET|
1740603|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||2-Sided|95.0|-0.13|0.07|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 18C|
1740604|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.01|||||2-Sided|95.0|-0.13|0.11|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14|
1740605|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.04|||||2-Sided|95.0|-0.16|0.08|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14|
1740606|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.03|||||2-Sided|95.0|-0.15|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 14|
1740607|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.0|||||2-Sided|95.0|-0.1|0.1|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V|
1740608|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||2-Sided|95.0|-0.16|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V|
1740609|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.06|||||2-Sided|95.0|-0.16|0.04|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 9V|
1740610|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.17|||||2-Sided|95.0|-0.33|-0.01|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B|
1740611|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.13|||||2-Sided|95.0|-0.04|0.29|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B|
1740612|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|0.3|||||2-Sided|95.0|0.13|0.46|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 6B|
1740613|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.27|||||2-Sided|95.0|-0.37|-0.16|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4|
1740614|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|Difference in log-transformed GM|-0.27|||||2-Sided|95.0|-0.38|-0.17|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4|
1740615|NCT00444457|3202186|Non-Inferiority or Equivalence|The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than –0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.|difference in log-transformed GM|-0.01|||||2-Sided|95.0|-0.11|0.09|||||2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.|Common serotypes - serotype 4|
1740682|NCT00442546|3202441|Superiority or Other|||||||0.7293|||||||Cochran-Mantel-Haenszel|||Week 6/ET|
1740683|NCT00442546|3202441|Superiority or Other|||||||0.7784|||||||Cochran-Mantel-Haenszel|||Week 4|
1740617|NCT00444028|3202204|Other|"The units on such analyses are generally those of slope (rise over run), with 1.000 being perfect. Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is as good as it gets."|Slope|0.909|||||2-Sided|90.0|0.832|0.987||||||Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered.|
1740618|NCT00443872|3202214|Superiority or Other||Mean Difference (Final Values)|0.4|||<|0.05|2-Sided||||||t-test, 2 sided||||
1740619|NCT00443872|3202215|Superiority or Other||Mean Difference (Final Values)|0.6|||>|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1740620|NCT00443872|3202216|Superiority or Other||Mean Difference (Final Values)|0.8|||>|0.05|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1740621|NCT00443872|3202217|Superiority or Other||Mean Difference (Final Values)|4.2|||<|0.01|2-Sided||||||t-test, 2 sided||||
1740622|NCT00443872|3202218|Superiority or Other||Mean Difference (Final Values)|2.2|||<|0.05|2-Sided|||||This analysis is for the motor section of the UPDRS|Wilcoxon (Mann-Whitney)||||
1740623|NCT00443872|3202218|Superiority or Other||Mean Difference (Final Values)|1.6|||<|0.01|2-Sided||||||Wilcoxon (Mann-Whitney)|||This analysis is for the Activities of Daily Living (ADL) section of the scale|
1740624|NCT00443872|3202219|Superiority or Other||Mean Difference (Final Values)|2.8|||<|0.05|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1740625|NCT00443872|3202220|Superiority or Other||Mean Difference (Final Values)|1.2|||<|0.01|2-Sided|95.0|||||t-test, 2 sided||Comparison of baseline vs. 3 month circumference of the Left and Right lower leg/ankle (change identical for both legs).|Change in pedal edema as measured by change in lower leg/ankle circumference in the left and right legs|
1740626|NCT00443872|3202221|Superiority or Other||Mean Difference (Final Values)|2.0|||<|0.01|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||||
1740627|NCT00443872|3202222|Superiority or Other||Mean Difference (Final Values)|4.5|Standard Deviation|1.0|<|0.01|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)|||Comparison of mean group scores at baseline and 12 weeks|
1740628|NCT00443846|3202224|Non-Inferiority or Equivalence|Non-inferiority was concluded if the lower bound of the 95% confidence interval of the difference (Group 1 - Group 2) in seroprotection rate was greater than -10%.|Difference (Group 1 - Group 2)|0.0|||||2-Sided|95.0|-3.7|3.7||||||Analysis of non-inferiority was based on the Miettinen and Nurminen method|
1740629|NCT00443781|3202229|Superiority or Other|||||||0.002|||||||McNemar|Exact test was used.||Mcnemar test was used to test the difference between paired PD (provocative discography) and F.A.D. (Functional Anesthetic Discography) proportions.|
1740630|NCT00443755|3202230|Superiority or Other|||||||0.76|||||||Wilcoxon (Mann-Whitney)||||
1740631|NCT00443755|3202231|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)||||
1740632|NCT00443755|3202232|Superiority or Other|||||||0.006|||||||Wilcoxon (Mann-Whitney)||||
1740633|NCT00443755|3202233|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1740634|NCT00443755|3202234|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1740635|NCT00443755|3202235|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1740636|NCT00443755|3202236|Superiority or Other|||||||0.13|||||||Wilcoxon (Mann-Whitney)||||
1740637|NCT00443755|3202237|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1740638|NCT00443755|3202238|Superiority or Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)||||
1740639|NCT00443755|3202239|Superiority or Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of mean change in non-HDL-C levels.|
1740640|NCT00443755|3202239|Superiority or Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of the mean change in HDL-C levels.|
1740641|NCT00443755|3202239|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||P-value is for comparison between groups of the mean change in triglyceride levels.|
1740642|NCT00443755|3202240|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1740643|NCT00443755|3202241|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1740644|NCT00443755|3202242|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1740645|NCT00443755|3202243|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1740646|NCT00443560|3202309|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1740647|NCT00443560|3202310|Superiority or Other||Odds Ratio (OR)|12.2|||<|0.01||95.0|9.9|15.0|||Chi-squared, Corrected||||
1740648|NCT00443560|3202311|Superiority or Other||Odds Ratio (OR)|3.3|||<|0.01||95.0|2.3|4.5|||Chi-squared, Corrected||||
1740649|NCT00443209|3202336|Superiority or Other||Odds Ratio (OR)|0.58|||||2-Sided|95.0|0.45|0.75|||||Based on mixed logistic regression model with a fixed effect term for treatment, baseline pain severity and a random effect term for participant, with the random effect following a normal distribution. An odds ratio >1 is in favor of telcagepant.||
1740650|NCT00443209|3202338|Superiority or Other||Treatment Difference|0.3|||||2-Sided|95.0|-2.0|2.0|||||Treatment Difference was compared using the MN method.||
1740651|NCT00443209|3202339|Superiority or Other||Treatment Difference|-5.2|||||2-Sided|95.0|-11.7|1.4|||||Treatment Difference was compared using the MN method.||
1740652|NCT00443209|3202340|Superiority or Other||Treatment Difference|-6.2|||<|0.001|2-Sided|95.0|-10.4|-2.6|||Miettenen and Nurminen method||Treatment Difference was compared using the Miettinen and Nurminen (MN) method.||
1740653|NCT00443053|3202360|Superiority or Other||Risk Ratio (RR)|0.19|||<|0.001|2-Sided|95.0|0.12|0.32|||Fisher Exact||||
1740654|NCT00443053|3202361|Superiority or Other||Risk Ratio (RR)|0.15|||<|0.001|2-Sided|95.0|0.08|0.26|||Fisher Exact||||
1740655|NCT00442936|3202387|Superiority or Other||Odds Ratio (OR)|5.21|||<|0.001|2-Sided|95.0|2.78|9.76|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740684|NCT00442546|3202441|Superiority or Other|||||||0.5954|||||||Cochran-Mantel-Haenszel|||Week 4|
1740656|NCT00442936|3202387|Superiority or Other||Odds Ratio (OR)|2.25|||<|0.021|2-Sided|95.0|1.13|4.47|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740657|NCT00442936|3202388|Superiority or Other||Odds Ratio (OR)|3.34|||<|0.001|2-Sided|95.0|2.08|5.35|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740658|NCT00442936|3202388|Superiority or Other||Odds Ratio (OR)|1.78|||<|0.026|2-Sided|95.0|1.07|2.97|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740659|NCT00442936|3202389|Superiority or Other||Odds Ratio (OR)|5.75|||<|0.001|2-Sided|95.0|3.15|10.51|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740660|NCT00442936|3202389|Superiority or Other||Odds Ratio (OR)|2.8|||<|0.002|2-Sided|95.0|1.47|5.35|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740661|NCT00442936|3202390|Superiority or Other||Odds Ratio (OR)|1.55||||0.006|2-Sided|95.0|1.13|2.13|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740662|NCT00442936|3202390|Superiority or Other||Odds Ratio (OR)|1.73|||<|0.001|2-Sided|95.0|1.25|2.39|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740663|NCT00442936|3202391|Superiority or Other||Odds Ratio (OR)|2.37|||<|0.001|2-Sided|95.0|1.73|3.25|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740664|NCT00442936|3202391|Superiority or Other||Odds Ratio (OR)|2.05|||<|0.001|2-Sided|95.0|1.49|2.82|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740665|NCT00442936|3202392|Superiority or Other||Odds Ratio (OR)|2.61|||<|0.001|2-Sided|95.0|1.89|3.61|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740666|NCT00442936|3202392|Superiority or Other||Odds Ratio (OR)|2.14|||<|0.001|2-Sided|95.0|1.54|2.97|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740667|NCT00442936|3202393|Superiority or Other||Odds Ratio (OR)|3.44|||<|0.001|2-Sided|95.0|2.47|4.79|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740668|NCT00442936|3202393|Superiority or Other||Odds Ratio (OR)|2.82|||<|0.001|2-Sided|95.0|2.02|3.95|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740669|NCT00442936|3202394|Superiority or Other||Odds Ratio (OR)|3.81|||<|0.001|2-Sided|95.0|2.42|6.0|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740670|NCT00442936|3202394|Superiority or Other||Odds Ratio (OR)|2.26|||<|0.001|2-Sided|95.0|1.4|3.66|||Regression, Logistic||From logistic model adjusting for geographic region, baseline migraine severity, and age. An odds ratio >1 is in favor of the first treatment group of the corresponding pairwise comparison.||
1740671|NCT00442897|3202395|Superiority or Other||Odds Ratio (OR)|2.579||||||95.0|1.32|5.06|||||Odds ratio was adjusted by baseline LDL strata.||
1740672|NCT00442897|3202396|Superiority or Other||Odds Ratio (OR)|3.714||||||95.0|1.77|7.78|||||Odds ratio was adjusted by baseline LDL strata.||
1740673|NCT00442559|3202437|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.032|2-Sided|95.0|-0.24|-0.01|||t-test, 2 sided|||Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=28 subjects for the within arm (single arm) comparison between BL and Week 12 scores.|
1740674|NCT00442559|3202437|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.006|2-Sided|95.0|-0.36|-0.07|||t-test, 2 sided|||Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.|
1740675|NCT00442559|3202438|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.027|2-Sided|95.0|-0.3|-0.02|||t-test, 2 sided|||Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=29 subjects for the within arm (single arm) comparison between BL and Week 12 scores.|
1740676|NCT00442559|3202438|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.015|2-Sided|95.0|-0.29|-0.03|||t-test, 2 sided|||Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.|
1740677|NCT00442546|3202440|Superiority or Other|||||||0.7733|||||||Cochran-Mantel-Haenszel|||Month 6|
1740678|NCT00442546|3202440|Superiority or Other|||||||0.2825|||||||Cochran-Mantel-Haenszel|||Month 6|
1740690|NCT00442546|3202442|Superiority or Other||Mean Difference (Final Values)|-1.833|Standard Error of the Mean|1.858||0.3618||95.0|-6.379|2.712|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740691|NCT00442546|3202442|Superiority or Other||Mean Difference (Final Values)|0.075|Standard Error of the Mean|1.139||0.9503||95.0|-2.853|3.003|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740692|NCT00442546|3202442|Superiority or Other||Mean Difference (Final Values)|-1.119|Standard Error of the Mean|1.024||0.324||95.0|-3.751|1.512|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740693|NCT00442546|3202442|Superiority or Other||Mean Difference (Final Values)|-0.167|Standard Error of the Mean|0.893||0.8557||95.0|-2.156|1.823|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740694|NCT00442546|3202442|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.755||0.5226||95.0|-1.181|2.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740695|NCT00442546|3202442|Superiority or Other||Mean Difference (Final Values)|-0.355|Standard Error of the Mean|0.3||0.2442||95.0|-0.964|0.253|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740696|NCT00442546|3202442|Superiority or Other||Mean Difference (Final Values)|0.208|Standard Error of the Mean|0.329||0.5299||95.0|-0.458|0.874|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740697|NCT00442546|3202443|Superiority or Other||Mean Difference (Final Values)|0.296|Standard Error of the Mean|0.859||0.742||95.0|-1.806|2.399|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740698|NCT00442546|3202443|Superiority or Other||Mean Difference (Final Values)|-2.352|Standard Error of the Mean|1.782||0.235||95.0|-6.712|2.008|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740699|NCT00442546|3202443|Superiority or Other||Mean Difference (Final Values)|-0.045|Standard Error of the Mean|0.982||0.9654||95.0|-2.568|2.479|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740700|NCT00442546|3202443|Superiority or Other||Mean Difference (Final Values)|-1.328|Standard Error of the Mean|0.882||0.1925||95.0|-3.596|0.94|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740701|NCT00442546|3202443|Superiority or Other||Mean Difference (Final Values)|-0.167|Standard Error of the Mean|0.893||0.8557||95.0|-2.156|1.823|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740702|NCT00442546|3202443|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.755||0.5226||95.0|-1.181|2.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740703|NCT00442546|3202443|Superiority or Other||Mean Difference (Final Values)|-0.167|Standard Error of the Mean|0.287||0.5641||95.0|-0.749|0.415|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740704|NCT00442546|3202443|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.315||0.9405||95.0|-0.614|0.661|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740705|NCT00442546|3202444|Superiority or Other||Mean Difference (Final Values)|2.351|Standard Error of the Mean|6.201||0.7055||95.0|-9.974|14.677|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740706|NCT00442546|3202444|Superiority or Other||Mean Difference (Final Values)|-0.128|Standard Error of the Mean|6.508||0.9843||95.0|-13.06|12.808|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740707|NCT00442546|3202444|Superiority or Other||Mean Difference (Final Values)|0.063|Standard Error of the Mean|5.873||0.9915||95.0|-11.68|11.811|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740708|NCT00442546|3202444|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|5.6||0.9859||95.0|-11.3|11.102|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740709|NCT00442546|3202444|Superiority or Other||Mean Difference (Final Values)|7.011|Standard Error of the Mean|8.62||0.4203||95.0|-10.35|24.372|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740710|NCT00442546|3202444|Superiority or Other||Mean Difference (Final Values)|2.956|Standard Error of the Mean|8.248||0.7217||95.0|-13.66|19.569|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740711|NCT00442546|3202444|Superiority or Other||Mean Difference (Final Values)|2.128|Standard Error of the Mean|3.155||0.5006||95.0|-4.088|8.344|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740712|NCT00442546|3202444|Superiority or Other||Mean Difference (Final Values)|0.579|Standard Error of the Mean|3.154||0.8545||95.0|-5.635|6.793|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740713|NCT00442546|3202445|Superiority or Other||Mean Difference (Final Values)|7.663|Standard Error of the Mean|4.664||0.104||95.0|-1.607|16.933|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740714|NCT00442546|3202445|Superiority or Other||Mean Difference (Final Values)|5.431|Standard Error of the Mean|4.895||0.2703||95.0|-4.298|15.161|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740715|NCT00442546|3202445|Superiority or Other||Mean Difference (Final Values)|6.248|Standard Error of the Mean|4.151||0.1375||95.0|-2.054|14.55|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740716|NCT00442546|3202445|Superiority or Other||Mean Difference (Final Values)|4.17|Standard Error of the Mean|3.958||0.2963||95.0|-3.747|12.086|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740717|NCT00442546|3202445|Superiority or Other||Mean Difference (Final Values)|3.286|Standard Error of the Mean|6.707||0.6266||95.0|-10.22|16.795|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740718|NCT00442546|3202445|Superiority or Other||Mean Difference (Final Values)|7.298|Standard Error of the Mean|6.418||0.2615||95.0|-5.628|20.224|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740719|NCT00442546|3202445|Superiority or Other||Mean Difference (Final Values)|4.176|Standard Error of the Mean|2.327||0.074||95.0|-0.409|8.761|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1741629|NCT00432809|3203950|Superiority or Other|||||||0.005|||||||Chi-squared||||
1741630|NCT00432809|3203950|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1740720|NCT00442546|3202445|Superiority or Other||Mean Difference (Final Values)|4.177|Standard Error of the Mean|2.326||0.0739||95.0|-0.407|8.76|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740721|NCT00442546|3202446|Superiority or Other||Mean Difference (Final Values)|4.963|Standard Error of the Mean|4.906||0.3146||95.0|-4.789|14.714|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740722|NCT00442546|3202446|Superiority or Other||Mean Difference (Final Values)|2.656|Standard Error of the Mean|5.149||0.6072||95.0|-7.578|12.891|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740723|NCT00442546|3202446|Superiority or Other||Mean Difference (Final Values)|3.156|Standard Error of the Mean|4.642||0.4992||95.0|-6.129|12.442|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740724|NCT00442546|3202446|Superiority or Other||Mean Difference (Final Values)|2.036|Standard Error of the Mean|4.426||0.6472||95.0|-6.818|10.89|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740725|NCT00442546|3202446|Superiority or Other||Mean Difference (Final Values)|5.146|Standard Error of the Mean|6.726||0.4482||95.0|-8.4|18.693|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740726|NCT00442546|3202446|Superiority or Other||Mean Difference (Final Values)|5.126|Standard Error of the Mean|6.436||0.4299||95.0|-7.836|18.088|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740727|NCT00442546|3202446|Superiority or Other||Mean Difference (Final Values)|3.155|Standard Error of the Mean|2.498||0.2078||95.0|-1.766|8.077|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740728|NCT00442546|3202446|Superiority or Other||Mean Difference (Final Values)|2.347|Standard Error of the Mean|2.497||0.3483||95.0|-2.573|7.268|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740729|NCT00442546|3202447|Superiority or Other|||||||0.191|||||||Log Rank||||
1740730|NCT00442546|3202447|Superiority or Other|||||||0.4024|||||||Log Rank||||
1740731|NCT00442546|3202448|Superiority or Other|||||||0.4023|||||||Log Rank||||
1740732|NCT00442546|3202448|Superiority or Other|||||||0.4365|||||||Log Rank||||
1740733|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|2.404|Standard Error of the Mean|2.393||0.3164||95.0|-2.317|7.124|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740734|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|1.374|Standard Error of the Mean|2.299||0.5507||95.0|-3.161|5.91|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740735|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|5.771|Standard Error of the Mean|2.421||0.0181||95.0|0.995|10.548|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740736|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|2.617|Standard Error of the Mean|2.339||0.2647||95.0|-1.997|7.231|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740737|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|3.331|Standard Error of the Mean|2.172||0.1267||95.0|-0.952|7.613|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740738|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|1.125|Standard Error of the Mean|2.115||0.5953||95.0|-3.045|5.296|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740739|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|17.941|Standard Error of the Mean|3.533||0.0038||95.0|8.859|27.023|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740740|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|12.941|Standard Error of the Mean|2.15||0.0018||95.0|7.414|18.468|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740741|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|11.173|Standard Error of the Mean|4.033||0.008||95.0|3.056|19.291|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740742|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|6.185|Standard Error of the Mean|3.993||0.1283||95.0|-1.853|14.223|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740743|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|7.135|Standard Error of the Mean|2.548||0.0058||95.0|2.098|12.172|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740744|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|3.171|Standard Error of the Mean|2.552||0.2161||95.0|-1.874|8.215|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740745|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|4.509|Standard Error of the Mean|2.343||0.0557||95.0|-0.11|9.129|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740746|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|0.901|Standard Error of the Mean|2.353||0.7022||95.0|-3.738|5.54|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740747|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|6.532|Standard Error of the Mean|2.675||0.0154||95.0|1.258|11.805|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740748|NCT00442546|3202449|Superiority or Other||Mean Difference (Final Values)|1.729|Standard Error of the Mean|2.631||0.5117||95.0|-3.457|6.916|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740749|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|2.272|Standard Error of the Mean|2.674||0.3966||95.0|-3.006|7.551|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740750|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|1.372|Standard Error of the Mean|2.566||0.5935||95.0|-3.694|6.438|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740751|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|5.316|Standard Error of the Mean|2.59||0.0416||95.0|0.204|10.427|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1741631|NCT00432809|3203951|Superiority or Other|||||||0.06|||||||Chi-squared||||
1741632|NCT00432809|3203951|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1740752|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|1.962|Standard Error of the Mean|2.576||0.4474||95.0|-3.122|7.046|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740753|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|2.341|Standard Error of the Mean|2.236||0.2966||95.0|-2.07|6.751|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740754|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|1.925|Standard Error of the Mean|2.195||0.3813||95.0|-2.403|6.254|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740755|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|-9.071|Standard Error of the Mean|11.7||0.4676||95.0|-37.7|19.558|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740756|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|-1.071|Standard Error of the Mean|6.911||0.8819||95.0|-17.98|15.838|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740757|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|5.306|Standard Error of the Mean|3.73||0.1616||95.0|-2.202|12.814|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740758|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|4.43|Standard Error of the Mean|3.693||0.2365||95.0|-3.004|11.865|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740759|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|3.946|Standard Error of the Mean|2.997||0.19||95.0|-1.979|9.871|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740760|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|0.928|Standard Error of the Mean|3.012||0.7585||95.0|-5.027|6.882|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740761|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|4.192|Standard Error of the Mean|2.778||0.1328||95.0|-1.284|9.669|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740762|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|0.803|Standard Error of the Mean|2.79||0.7738||95.0|-4.698|6.304|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740763|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|5.006|Standard Error of the Mean|3.025||0.0996||95.0|-0.96|10.971|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740764|NCT00442546|3202450|Superiority or Other||Mean Difference (Final Values)|-0.862|Standard Error of the Mean|2.999||0.7742||95.0|-6.775|5.052|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740765|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|1.327|Standard Error of the Mean|1.665||0.427||95.0|-1.972|4.626|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740766|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|-1.119|Standard Error of the Mean|1.641||0.4968||95.0|-4.371|2.133|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740767|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|1.61|Standard Error of the Mean|1.935||0.407||95.0|-2.223|5.443|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740768|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|1.537|Standard Error of the Mean|1.949||0.4319||95.0|-2.324|5.398|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740769|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|-0.346|Standard Error of the Mean|2.441||0.8875||95.0|-5.177|4.485|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740770|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|0.644|Standard Error of the Mean|2.519||0.7987||95.0|-4.343|5.63|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740771|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|18.513|Standard Error of the Mean|8.491||0.2738||95.0|-89.376|126.402|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740772|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|-27.25|Standard Error of the Mean|45.322||0.5531||95.0|-120.59|66.092|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740773|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|40.51|Standard Error of the Mean|45.612||0.3829||95.0|-53.429|134.449|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740774|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|-11.769|Standard Error of the Mean|11.245||0.2989||95.0|-34.197|10.659|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740775|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|-13.915|Standard Error of the Mean|11.101||0.2142||95.0|-36.055|8.226|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740776|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|-7.294|Standard Error of the Mean|10.227||0.4773||95.0|-27.563|12.976|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740777|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|-6.815|Standard Error of the Mean|10.371||0.5125||95.0|-27.369|13.74|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740778|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|-2.991|Standard Error of the Mean|11.786||0.8003||95.0|-26.438|20.455|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740779|NCT00442546|3202451|Superiority or Other||Mean Difference (Final Values)|-6.812|Standard Error of the Mean|12.055||0.5736||95.0|-30.792|17.169|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740780|NCT00442546|3202452|Superiority or Other||Mean Difference (Final Values)|44.964|Standard Error of the Mean|12.295||0.0353||95.0|5.837|84.091|||ANOVA||Mean difference (final values) = Least squares mean difference|5 hours|
1740781|NCT00442546|3202452|Superiority or Other||Mean Difference (Final Values)|86.335|Standard Error of the Mean|22.737||0.0321||95.0|13.976|158.693|||ANOVA||Mean difference (final values) = Least squares mean difference|5 hours|
1741633|NCT00432809|3203951|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1740782|NCT00442546|3202452|Superiority or Other||Mean Difference (Final Values)|-10.023|Standard Error of the Mean|7.68||0.1991||95.0|-25.533|5.487|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours|
1740783|NCT00442546|3202452|Superiority or Other||Mean Difference (Final Values)|-1.915|Standard Error of the Mean|7.391||0.7969||95.0|-16.842|13.012|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours|
1740784|NCT00442546|3202452|Superiority or Other||Mean Difference (Final Values)|0.275|Standard Error of the Mean|4.232||0.9482||95.0|-8.085|8.635|||ANOVA||Mean difference (final values) = Least squares mean difference|3 hours|
1740785|NCT00442546|3202452|Superiority or Other||Mean Difference (Final Values)|0.164|Standard Error of the Mean|4.347||0.9699||95.0|-8.423|8.751|||ANOVA||Mean difference (final values) = Least squares mean difference|3 hours|
1740786|NCT00442546|3202452|Superiority or Other||Mean Difference (Final Values)|0.365|Standard Error of the Mean|3.95||0.9266||95.0|-7.425|8.154|||ANOVA||Mean difference (final values) = Least squares mean difference|2 hours|
1740787|NCT00442546|3202452|Superiority or Other||Mean Difference (Final Values)|-2.662|Standard Error of the Mean|4.045||0.5113||95.0|-10.639|5.316|||ANOVA||Mean difference (final values) = Least squares mean difference|2 hours|
1740788|NCT00442546|3202452|Superiority or Other||Mean Difference (Final Values)|-2.813|Standard Error of the Mean|3.917||0.4736||95.0|-10.542|4.917|||ANOVA||Mean difference (final values) = Least squares mean difference|1 hour|
1740789|NCT00442546|3202452|Superiority or Other||Mean Difference (Final Values)|0.889|Standard Error of the Mean|3.946||0.822||95.0|-6.898|8.675|||ANOVA||Mean difference (final values) = Least squares mean difference|1 hour|
1740790|NCT00442546|3202452|Superiority or Other||Mean Difference (Final Values)|0.111|Standard Error of the Mean|3.322||0.9733||95.0|-6.436|6.659|||ANOVA||Mean difference (final values) = Least squares mean difference|Day 1|
1740791|NCT00442546|3202452|Superiority or Other||Mean Difference (Final Values)|-0.859|Standard Error of the Mean|3.315||0.7958||95.0|-7.391|5.673|||ANOVA||Mean difference (final values) = Least squares mean difference|Day 1|
1740792|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-0.156|Standard Error of the Mean|0.323||0.6294||95.0|-0.794|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740793|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-0.264|Standard Error of the Mean|0.321||0.4117||95.0|-0.897|0.369|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740794|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.313||0.119||95.0|-1.108|0.127|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740795|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-0.351|Standard Error of the Mean|0.3||0.2436||95.0|-0.943|0.241|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740796|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-0.128|Standard Error of the Mean|0.314||0.6829||95.0|-0.747|0.49|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740797|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-0.419|Standard Error of the Mean|0.306||0.1731||95.0|-1.023|0.185|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740798|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-0.569|Standard Error of the Mean|0.386||0.1413||95.0|-1.329|0.191|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740799|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-0.515|Standard Error of the Mean|0.379||0.1754||95.0|-1.261|0.231|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740800|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|5.909|Standard Error of the Mean|3.754||0.1762||95.0|-3.74|15.559|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740801|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|1.866|Standard Error of the Mean|1.973||0.3878||95.0|-3.207|6.939|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740802|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-1.568|Standard Error of the Mean|0.682||0.0258||95.0|-2.939|-0.198|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740803|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|0.874|Standard Error of the Mean|0.725||0.2335||95.0|-0.582|2.33|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740804|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-1.036|Standard Error of the Mean|0.457||0.0248||95.0|-1.939|-0.133|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740805|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-0.719|Standard Error of the Mean|0.448||0.1106||95.0|-1.605|0.166|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740806|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-0.619|Standard Error of the Mean|0.413||0.135||95.0|-1.432|0.194|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740807|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-0.197|Standard Error of the Mean|0.405||0.6274||95.0|-0.995|0.601|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740808|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-1.81|Standard Error of the Mean|0.501||0.0004||95.0|-2.798|-0.822|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740809|NCT00442546|3202453|Superiority or Other||Mean Difference (Final Values)|-1.029|Standard Error of the Mean|0.495||0.0388||95.0|-2.004|-0.053|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740810|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|0.851|Standard Error of the Mean|1.768||0.6505||95.0|-3.693|5.395|||ANOVA||Mean difference (final values) = Least squares mean difference|104 hours|
1740811|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|1.672|Standard Error of the Mean|1.08||0.1821||95.0|-1.103|4.448|||ANOVA||Mean difference (final values) = Least squares mean difference|104 hours|
1740812|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-0.126|Standard Error of the Mean|0.905||0.89||95.0|-1.965|1.713|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740814|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-1.147|Standard Error of the Mean|0.894||0.208||95.0|-2.962|0.668|||ANOVA||Mean difference (final values) = Least squares mean difference|88 hours|
1740815|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|0.352|Standard Error of the Mean|0.89||0.6953||95.0|-1.456|2.159|||ANOVA||Mean difference (final values) = Least squares mean difference|88 hours|
1740816|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-1.882|Standard Deviation|0.76||0.0167||95.0|-3.408|-0.356|||ANOVA||Mean difference (final values) = Least squares mean difference|80 hours|
1740817|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|1.027|Standard Error of the Mean|0.895||0.2567||95.0|-0.77|2.823|||ANOVA||Mean difference (final values) = Least squares mean difference|80 hours|
1740818|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-0.555|Standard Error of the Mean|0.481||0.2506||95.0|-1.507|0.397|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740819|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|0.146|Standard Error of the Mean|0.476||0.76||95.0|-0.796|1.087|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740820|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-1.086|Standard Error of the Mean|0.515||0.0373||95.0|-2.107|-0.065|||ANOVA||Mean difference (final values) = Least squares mean difference|64 hours|
1740821|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-0.358|Standard Error of the Mean|0.476||0.4539||95.0|-1.302|0.586|||ANOVA||Mean difference (final values) = Least squares mean difference|64 hours|
1740822|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-0.402|Standard Error of the Mean|0.448||0.3705||95.0|-1.286|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|56 hours|
1740823|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|0.255|Standard Error of the Mean|0.44||0.5624||95.0|-0.614|1.125|||ANOVA||Mean difference (final values) = Least squares mean difference|56 hours|
1740824|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|0.285|Standard Error of the Mean|0.391||0.4673||95.0|-0.487|1.056|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740825|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|0.311|Standard Error of the Mean|0.386||0.4216||95.0|-0.45|1.072|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740826|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-0.081|Standard Error of the Mean|0.481||0.8665||95.0|-1.032|0.87|||ANOVA||Mean difference (final values) = Least squares mean difference|40 hours|
1740827|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-0.182|Standard Error of the Mean|0.465||0.6954||95.0|-1.101|0.736|||ANOVA||Mean difference (final values) = Least squares mean difference|40 hours|
1740828|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|0.162|Standard Error of the Mean|0.412||0.6947||95.0|-0.65|0.974|||ANOVA||Mean difference (final values) = Least squares mean difference|32 hours|
1740829|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|0.105|Standard Error of the Mean|0.41||0.7975||95.0|-0.703|0.914|||ANOVA||Mean difference (final values) = Least squares mean difference|32 hours|
1740830|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-0.291|Standard Error of the Mean|0.366||0.426||95.0|-1.012|0.429|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740831|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-0.336|Standard Error of the Mean|0.364||0.3561||95.0|-1.053|0.38|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740832|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-0.715|Standard Error of the Mean|0.479||0.1367||95.0|-1.66|0.229|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours|
1740833|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-0.005|Standard Error of the Mean|0.483||0.9921||95.0|-0.958|0.948|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours|
1740834|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-0.591|Standard Error of the Mean|0.425||0.1658||95.0|-1.428|0.247|||ANOVA||Mean difference (final values) = Least squares mean difference|8 hours|
1740835|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-0.036|Standard Error of the Mean|0.42||0.9312||95.0|-0.863|0.791|||ANOVA||Mean difference (final values) = Least squares mean difference|8 hours|
1740836|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|-0.809|Standard Error of the Mean|0.477||0.0916||95.0|-1.75|0.132|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours|
1740837|NCT00442546|3202454|Superiority or Other||Mean Difference (Final Values)|0.578|Standard Error of the Mean|0.471||0.2211||95.0|-0.35|1.506|||ANOVA||Mean difference (final values) = Least squares mean difference|4 hours|
1740838|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.268||0.9899||95.0|-0.533|0.526|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740839|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-0.015|Standard Error of the Mean|0.263||0.9552||95.0|-0.535|0.506|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740840|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-0.318|Standard Error of the Mean|0.263||0.2271||95.0|-0.836|0.2|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740841|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-0.207|Standard Error of the Mean|0.251||0.4107||95.0|-0.702|0.288|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740842|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-0.013|Standard Error of the Mean|0.27||0.9605||95.0|-0.546|0.519|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740843|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-0.296|Standard Error of the Mean|0.262||0.2595||95.0|-0.813|0.22|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740844|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-1.347|Standard Error of the Mean|1.992||0.5288||95.0|-6.467|3.773|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1741634|NCT00432809|3203952|Superiority or Other|||||||0.05|||||||Chi-squared||||
1740845|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-0.077|Standard Error of the Mean|1.155||0.9497||95.0|-3.047|2.893|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740846|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-1.614|Standard Error of the Mean|0.616||0.0115||95.0|-2.851|-0.378|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740847|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|0.102|Standard Error of the Mean|0.641||0.8744||95.0|-1.184|1.387|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740848|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-0.446|Standard Error of the Mean|0.391||0.256||95.0|-1.22|0.327|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740849|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|0.094|Standard Error of the Mean|0.382||0.8055||95.0|-0.662|0.85|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740850|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-0.206|Standard Error of the Mean|0.332||0.5352||95.0|-0.859|0.448|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740851|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|0.002|Standard Error of the Mean|0.33||0.9942||95.0|-0.648|0.652|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740852|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-0.303|Standard Error of the Mean|0.354||0.3918||95.0|-1.0|0.394|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740853|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|0.044|Standard Error of the Mean|0.344||0.8995||95.0|-0.635|0.722|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740854|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-1.903|Standard Error of the Mean|0.706||0.0089||95.0|-3.311|-0.494|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours|
1740855|NCT00442546|3202455|Superiority or Other||Mean Difference (Final Values)|-1.036|Standard Error of the Mean|0.709||0.1486||95.0|-2.452|0.379|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours|
1740856|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|0.075|Standard Error of the Mean|0.333||0.8231||95.0|-0.584|0.733|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740857|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|0.104|Standard Error of the Mean|0.327||0.7499||95.0|-0.541|0.75|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740858|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|-0.236|Standard Error of the Mean|0.32||0.4607||95.0|-0.868|0.395|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740859|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|-0.146|Standard Error of the Mean|0.306||0.6341||95.0|-0.75|0.458|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740860|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|0.196|Standard Error of the Mean|0.303||0.5183||95.0|-0.402|0.794|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740861|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|-0.141|Standard Error of the Mean|0.295||0.6332||95.0|-0.722|0.44|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740862|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|-2.71|Standard Error of the Mean|1.856||0.204||95.0|-7.479|2.06|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740863|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|-1.141|Standard Error of the Mean|0.956||0.286||95.0|-3.598|1.316|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740864|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|-1.845|Standard Error of the Mean|0.757||0.0183||95.0|-3.364|-0.326|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740865|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|0.147|Standard Error of the Mean|0.777||0.8503||95.0|-1.411|1.706|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740866|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|0.013|Standard Error of the Mean|0.459||0.9778||95.0|-0.895|0.921|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740867|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|0.358|Standard Error of the Mean|0.453||0.4309||95.0|-0.538|1.254|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740868|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|-0.339|Standard Error of the Mean|0.371||0.3619||95.0|-1.07|0.392|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740869|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|-0.038|Standard Error of the Mean|0.37||0.9185||95.0|-0.766|0.691|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740870|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|0.089|Standard Error of the Mean|0.414||0.8299||95.0|-0.727|0.905|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740871|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|0.276|Standard Error of the Mean|0.402||0.4925||95.0|-0.516|1.069|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740872|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|-1.768|Standard Error of the Mean|0.764||0.0237||95.0|-3.293|-0.243|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours|
1740873|NCT00442546|3202456|Superiority or Other||Mean Difference (Final Values)|-1.553|Standard Error of the Mean|0.77||0.0476||95.0|-3.089|-0.017|||ANOVA||Mean difference (final values) = Least squares mean difference|12 hours|
1740874|NCT00442546|3202457|Superiority or Other||Mean Difference (Final Values)|0.227|Standard Error of the Mean|0.573||0.6934||95.0|-0.918|1.372|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740875|NCT00442546|3202457|Superiority or Other||Mean Difference (Final Values)|1.186|Standard Error of the Mean|0.529||0.0283||95.0|0.13|2.242|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1741635|NCT00432809|3203952|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1740876|NCT00442546|3202457|Superiority or Other||Mean Difference (Final Values)|-0.558|Standard Error of the Mean|0.598||0.353||95.0|-1.748|0.631|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740877|NCT00442546|3202457|Superiority or Other||Mean Difference (Final Values)|-0.224|Standard Error of the Mean|0.64||0.7276||95.0|-1.498|1.05|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740878|NCT00442546|3202457|Superiority or Other||Mean Difference (Final Values)|-0.368|Standard Error of the Mean|0.394||0.3507||95.0|-1.145|0.408|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740879|NCT00442546|3202457|Superiority or Other||Mean Difference (Final Values)|-0.223|Standard Error of the Mean|0.385||0.5626||95.0|-0.982|0.536|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740880|NCT00442546|3202457|Superiority or Other||Mean Difference (Final Values)|-0.502|Standard Error of the Mean|0.397||0.2077||95.0|-1.284|0.281|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740881|NCT00442546|3202457|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.389||0.6266||95.0|-0.958|0.578|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740882|NCT00442546|3202457|Superiority or Other||Mean Difference (Final Values)|-0.572|Standard Error of the Mean|0.466||0.2205||95.0|-1.49|0.346|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740883|NCT00442546|3202457|Superiority or Other||Mean Difference (Final Values)|-0.448|Standard Error of the Mean|0.458||0.3285||95.0|-1.35|0.454|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740884|NCT00442546|3202457|Superiority or Other||Mean Difference (Final Values)|-0.665|Standard Error of the Mean|0.42||0.1148||95.0|-1.494|0.163|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740885|NCT00442546|3202457|Superiority or Other||Mean Difference (Final Values)|-0.611|Standard Error of the Mean|0.417||0.1448||95.0|-1.434|0.212|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740886|NCT00442546|3202458|Superiority or Other||Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.343||0.3529||95.0|-0.364|1.005|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740887|NCT00442546|3202458|Superiority or Other||Mean Difference (Final Values)|0.598|Standard Error of the Mean|0.315||0.0623||95.0|-0.032|1.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740888|NCT00442546|3202458|Superiority or Other||Mean Difference (Final Values)|-0.533|Standard Error of the Mean|0.575||0.3568||95.0|-1.679|0.612|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740889|NCT00442546|3202458|Superiority or Other||Mean Difference (Final Values)|-0.468|Standard Error of the Mean|0.611||0.4461||95.0|-1.684|0.748|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740890|NCT00442546|3202458|Superiority or Other||Mean Difference (Final Values)|0.113|Standard Error of the Mean|0.39||0.7731||95.0|-0.656|0.881|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740891|NCT00442546|3202458|Superiority or Other||Mean Difference (Final Values)|0.094|Standard Error of the Mean|0.376||0.8037||95.0|-0.648|0.835|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740892|NCT00442546|3202458|Superiority or Other||Mean Difference (Final Values)|-0.395|Standard Error of the Mean|0.394||0.3179||95.0|-1.173|0.383|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740893|NCT00442546|3202458|Superiority or Other||Mean Difference (Final Values)|-0.062|Standard Error of the Mean|0.384||0.8721||95.0|-0.819|0.695|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740894|NCT00442546|3202458|Superiority or Other||Mean Difference (Final Values)|-0.293|Standard Error of the Mean|0.47||0.5344||95.0|-1.219|0.634|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740895|NCT00442546|3202458|Superiority or Other||Mean Difference (Final Values)|0.179|Standard Error of the Mean|0.46||0.6978||95.0|-0.727|1.085|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740896|NCT00442546|3202458|Superiority or Other||Mean Difference (Final Values)|-0.135|Standard Error of the Mean|0.554||0.8076||95.0|-1.227|0.957|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740897|NCT00442546|3202458|Superiority or Other||Mean Difference (Final Values)|0.006|Standard Error of the Mean|0.546||0.9912||95.0|-1.07|1.082|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740898|NCT00442546|3202459|Superiority or Other||Mean Difference (Final Values)|0.265|Standard Error of the Mean|0.382||0.49||95.0|-0.497|1.027|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740899|NCT00442546|3202459|Superiority or Other||Mean Difference (Final Values)|0.446|Standard Error of the Mean|0.352||0.2098||95.0|-0.257|1.15|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740900|NCT00442546|3202459|Superiority or Other||Mean Difference (Final Values)|-0.022|Standard Error of the Mean|0.469||0.9634||95.0|-0.955|0.912|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740901|NCT00442546|3202459|Superiority or Other||Mean Difference (Final Values)|-0.489|Standard Error of the Mean|0.505||0.3361||95.0|-1.496|0.517|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740902|NCT00442546|3202459|Superiority or Other||Mean Difference (Final Values)|0.143|Standard Error of the Mean|0.339||0.6727||95.0|-0.525|0.812|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740903|NCT00442546|3202459|Superiority or Other||Mean Difference (Final Values)|0.262|Standard Error of the Mean|0.332||0.4315||95.0|-0.393|0.917|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740904|NCT00442546|3202459|Superiority or Other||Mean Difference (Final Values)|-0.335|Standard Error of the Mean|0.368||0.364||95.0|-1.06|0.391|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740905|NCT00442546|3202459|Superiority or Other||Mean Difference (Final Values)|0.204|Standard Error of the Mean|0.362||0.5737||95.0|-0.51|0.918|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740906|NCT00442546|3202459|Superiority or Other||Mean Difference (Final Values)|-0.081|Standard Error of the Mean|0.39||0.8353||95.0|-0.849|0.687|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1741636|NCT00432809|3203952|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1740907|NCT00442546|3202459|Superiority or Other||Mean Difference (Final Values)|-0.128|Standard Error of the Mean|0.384||0.7385||95.0|-0.884|0.628|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740908|NCT00442546|3202459|Superiority or Other||Mean Difference (Final Values)|-0.254|Standard Error of the Mean|0.45||0.5733||95.0|-1.142|0.634|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740909|NCT00442546|3202459|Superiority or Other||Mean Difference (Final Values)|-0.064|Standard Error of the Mean|0.448||0.8868||95.0|-0.947|0.82|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740910|NCT00442546|3202460|Superiority or Other||Mean Difference (Final Values)|0.463|Standard Error of the Mean|0.388||0.2367||95.0|-0.311|1.237|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740911|NCT00442546|3202460|Superiority or Other||Mean Difference (Final Values)|0.831|Standard Error of the Mean|0.357||0.0231||95.0|0.118|1.545|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740912|NCT00442546|3202460|Superiority or Other||Mean Difference (Final Values)|-0.378|Standard Error of the Mean|0.37||0.31||95.0|-1.114|0.358|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740913|NCT00442546|3202460|Superiority or Other||Mean Difference (Final Values)|-0.702|Standard Error of the Mean|0.397||0.0813||95.0|-1.493|0.089|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740914|NCT00442546|3202460|Superiority or Other||Mean Difference (Final Values)|-0.154|Standard Error of the Mean|0.327||0.6386||95.0|-0.799|0.491|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740915|NCT00442546|3202460|Superiority or Other||Mean Difference (Final Values)|-0.272|Standard Error of the Mean|0.321||0.3975||95.0|-0.906|0.361|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740916|NCT00442546|3202460|Superiority or Other||Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.359||0.9585||95.0|-0.727|0.689|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740917|NCT00442546|3202460|Superiority or Other||Mean Difference (Final Values)|0.061|Standard Error of the Mean|0.353||0.8637||95.0|-0.636|0.757|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740918|NCT00442546|3202460|Superiority or Other||Mean Difference (Final Values)|-0.439|Standard Error of the Mean|0.407||0.2814||95.0|-1.242|0.363|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740919|NCT00442546|3202460|Superiority or Other||Mean Difference (Final Values)|0.086|Standard Error of the Mean|0.4||0.8306||95.0|-0.703|0.875|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740920|NCT00442546|3202460|Superiority or Other||Mean Difference (Final Values)|-0.936|Standard Error of the Mean|0.409||0.023||95.0|-1.741|-0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740921|NCT00442546|3202460|Superiority or Other||Mean Difference (Final Values)|-0.765|Standard Error of the Mean|0.407||0.0613||95.0|-1.568|0.037|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740922|NCT00442546|3202461|Superiority or Other||Mean Difference (Final Values)|0.307|Standard Error of the Mean|0.492||0.5347||95.0|-0.675|1.289|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740923|NCT00442546|3202461|Superiority or Other||Mean Difference (Final Values)|0.328|Standard Error of the Mean|0.45||0.4682||95.0|-0.57|1.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740924|NCT00442546|3202461|Superiority or Other||Mean Difference (Final Values)|-0.422|Standard Error of the Mean|0.556||0.4501||95.0|-1.53|0.685|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740925|NCT00442546|3202461|Superiority or Other||Mean Difference (Final Values)|-0.108|Standard Error of the Mean|0.592||0.8558||95.0|-1.286|1.07|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740926|NCT00442546|3202461|Superiority or Other||Mean Difference (Final Values)|-0.125|Standard Error of the Mean|0.351||0.7216||95.0|-0.818|0.567|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740927|NCT00442546|3202461|Superiority or Other||Mean Difference (Final Values)|0.081|Standard Error of the Mean|0.34||0.8117||95.0|-0.59|0.752|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740928|NCT00442546|3202461|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.336||0.9767||95.0|-0.674|0.654|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740929|NCT00442546|3202461|Superiority or Other||Mean Difference (Final Values)|0.044|Standard Error of the Mean|0.329||0.8943||95.0|-0.605|0.692|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740930|NCT00442546|3202461|Superiority or Other||Mean Difference (Final Values)|0.003|Standard Error of the Mean|0.39||0.9947||95.0|-0.765|0.77|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740931|NCT00442546|3202461|Superiority or Other||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.38||0.479||95.0|-1.02|0.48|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740932|NCT00442546|3202461|Superiority or Other||Mean Difference (Final Values)|-0.265|Standard Error of the Mean|0.444||0.5516||95.0|-1.141|0.611|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740933|NCT00442546|3202461|Superiority or Other||Mean Difference (Final Values)|-0.969|Standard Error of the Mean|0.439||0.0284||95.0|-1.835|-0.104|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740934|NCT00442546|3202462|Superiority or Other||Mean Difference (Final Values)|0.995|Standard Error of the Mean|0.485||0.0441||95.0|0.027|1.962|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740935|NCT00442546|3202462|Superiority or Other||Mean Difference (Final Values)|0.994|Standard Error of the Mean|0.451||0.0311||95.0|0.093|1.895|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740936|NCT00442546|3202462|Superiority or Other||Mean Difference (Final Values)|0.099|Standard Error of the Mean|0.582||0.8659||95.0|-1.06|1.257|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740937|NCT00442546|3202462|Superiority or Other||Mean Difference (Final Values)|-0.424|Standard Error of the Mean|0.621||0.4967||95.0|-1.66|0.812|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1741637|NCT00432809|3203953|Superiority or Other|||||||0.68|||||||Chi-squared||||
1740938|NCT00442546|3202462|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.356||0.9466||95.0|-0.678|0.726|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740939|NCT00442546|3202462|Superiority or Other||Mean Difference (Final Values)|-0.161|Standard Error of the Mean|0.347||0.6433||95.0|-0.845|0.523|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740940|NCT00442546|3202462|Superiority or Other||Mean Difference (Final Values)|0.274|Standard Error of the Mean|0.372||0.4615||95.0|-0.459|1.008|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740941|NCT00442546|3202462|Superiority or Other||Mean Difference (Final Values)|0.384|Standard Error of the Mean|0.365||0.2939||95.0|-0.336|1.104|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740942|NCT00442546|3202462|Superiority or Other||Mean Difference (Final Values)|-0.151|Standard Error of the Mean|0.442||0.7336||95.0|-1.021|0.72|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740943|NCT00442546|3202462|Superiority or Other||Mean Difference (Final Values)|-0.008|Standard Error of the Mean|0.434||0.986||95.0|-0.862|0.847|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740944|NCT00442546|3202462|Superiority or Other||Mean Difference (Final Values)|0.025|Standard Error of the Mean|0.467||0.957||95.0|-0.895|0.946|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740945|NCT00442546|3202462|Superiority or Other||Mean Difference (Final Values)|-0.258|Standard Error of the Mean|0.463||0.5786||95.0|-1.17|0.655|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740946|NCT00442546|3202463|Superiority or Other||Mean Difference (Final Values)|0.433|Standard Error of the Mean|0.295||0.146||95.0|-0.155|1.022|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740947|NCT00442546|3202463|Superiority or Other||Mean Difference (Final Values)|0.175|Standard Error of the Mean|0.268||0.5151||95.0|-0.36|0.711|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740948|NCT00442546|3202463|Superiority or Other||Mean Difference (Final Values)|-0.503|Standard Error of the Mean|0.416||0.23||95.0|-1.332|0.325|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740949|NCT00442546|3202463|Superiority or Other||Mean Difference (Final Values)|-1.111|Standard Error of the Mean|0.441||0.0138||95.0|-1.989|-0.233|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740950|NCT00442546|3202463|Superiority or Other||Mean Difference (Final Values)|-0.053|Standard Error of the Mean|0.245||0.829||95.0|-0.535|0.429|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740951|NCT00442546|3202463|Superiority or Other||Mean Difference (Final Values)|-0.354|Standard Error of the Mean|0.24||0.142||95.0|-0.827|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740952|NCT00442546|3202463|Superiority or Other||Mean Difference (Final Values)|-0.026|Standard Error of the Mean|0.305||0.9333||95.0|-0.628|0.577|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740953|NCT00442546|3202463|Superiority or Other||Mean Difference (Final Values)|-0.184|Standard Error of the Mean|0.3||0.5419||95.0|-0.776|0.409|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740954|NCT00442546|3202463|Superiority or Other||Mean Difference (Final Values)|-0.301|Standard Error of the Mean|0.324||0.3527||95.0|-0.939|0.336|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740955|NCT00442546|3202463|Superiority or Other||Mean Difference (Final Values)|-0.105|Standard Error of the Mean|0.319||0.7416||95.0|-0.733|0.523|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740956|NCT00442546|3202463|Superiority or Other||Mean Difference (Final Values)|-0.907|Standard Error of the Mean|0.374||0.0161||95.0|-1.644|-0.17|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740957|NCT00442546|3202463|Superiority or Other||Mean Difference (Final Values)|-0.786|Standard Error of the Mean|0.372||0.0359||95.0|-1.52|-0.052|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740958|NCT00442546|3202464|Superiority or Other||Mean Difference (Final Values)|0.448|Standard Error of the Mean|0.314||0.1591||95.0|-0.18|1.076|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740959|NCT00442546|3202464|Superiority or Other||Mean Difference (Final Values)|0.661|Standard Error of the Mean|0.298||0.0255||95.0|0.084|1.239|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 6|
1740960|NCT00442546|3202464|Superiority or Other||Mean Difference (Final Values)|-0.294|Standard Error of the Mean|0.413||0.4784||95.0|-1.116|0.528|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740961|NCT00442546|3202464|Superiority or Other||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.439||0.2682||95.0|-1.364|0.385|||ANOVA||Mean difference (final values) = Least squares mean difference|Month 3|
1740962|NCT00442546|3202464|Superiority or Other||Mean Difference (Final Values)|-0.025|Standard Error of the Mean|0.285||0.9307||95.0|-0.588|0.538|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740963|NCT00442546|3202464|Superiority or Other||Mean Difference (Final Values)|-0.066|Standard Error of the Mean|0.278||0.8133||95.0|-0.614|0.482|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740964|NCT00442546|3202464|Superiority or Other||Mean Difference (Final Values)|-0.099|Standard Error of the Mean|0.288||0.7325||95.0|-0.667|0.469|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740965|NCT00442546|3202464|Superiority or Other||Mean Difference (Final Values)|0.067|Standard Error of the Mean|0.282||0.8116||95.0|-0.489|0.624|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740966|NCT00442546|3202464|Superiority or Other||Mean Difference (Final Values)|-0.222|Standard Error of the Mean|0.331||0.5024||95.0|-0.875|0.43|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740967|NCT00442546|3202464|Superiority or Other||Mean Difference (Final Values)|-0.068|Standard Error of the Mean|0.325||0.8355||95.0|-0.707|0.572|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740968|NCT00442546|3202464|Superiority or Other||Mean Difference (Final Values)|-0.398|Standard Error of the Mean|0.324||0.2208||95.0|-1.038|0.241|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1741638|NCT00432809|3203953|Superiority or Other|||||||1.001|||||||Chi-squared||||
1740969|NCT00442546|3202464|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.321||0.1537||95.0|-1.093|0.173|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740970|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.089||0.0201||95.0|0.033|0.386|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740971|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.008|Standard Error of the Mean|0.087||0.9243||95.0|-0.164|0.181|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740972|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.204|Standard Error of the Mean|0.083||0.0155||95.0|0.039|0.368|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740973|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.084|Standard Error of the Mean|0.082||0.305||95.0|-0.077|0.245|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740974|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.131||0.2863||95.0|-0.118|0.399|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740975|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.157|Standard Error of the Mean|0.128||0.2213||95.0|-0.096|0.41|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740976|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.155||0.3343||95.0|-0.155|0.455|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740977|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.077|Standard Error of the Mean|0.155||0.6203||95.0|-0.229|0.383|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740978|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.103|Standard Error of the Mean|0.116||0.3762||95.0|-0.13|0.336|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740979|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|-0.069|Standard Error of the Mean|0.116||0.5569||95.0|-0.302|0.165|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740980|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.205|Standard Error of the Mean|0.187||0.2742||95.0|-0.164|0.574|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740981|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.156|Standard Error of the Mean|0.195||0.4243||95.0|-0.229|0.541|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740982|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|-0.044|Standard Error of the Mean|0.188||0.8158||95.0|-0.415|0.327|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740983|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.034|Standard Error of the Mean|0.188||0.8577||95.0|-0.337|0.405|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1740984|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.044|Standard Error of the Mean|0.19||0.8159||95.0|-0.329|0.418|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740985|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.025|Standard Error of the Mean|0.192||0.8972||95.0|-0.353|0.403|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1740986|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.044|Standard Error of the Mean|0.204||0.8282||95.0|-0.359|0.447|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740987|NCT00442546|3202465|Superiority or Other||Mean Difference (Final Values)|0.049|Standard Error of the Mean|0.202||0.8071||95.0|-0.35|0.449|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1740988|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|0.126|Standard Error of the Mean|0.059||0.0355||95.0|0.009|0.243|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740989|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|0.001|Standard Error of the Mean|0.058||0.9863||95.0|-0.114|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1740990|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|0.056|Standard Error of the Mean|0.062||0.3717||95.0|-0.067|0.178|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740991|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|0.025|Standard Error of the Mean|0.061||0.6771||95.0|-0.095|0.146|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1740992|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|-0.001|Standard Error of the Mean|0.074||0.9841||95.0|-0.147|0.144|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740993|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|0.013|Standard Error of the Mean|0.073||0.8559||95.0|-0.13|0.156|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1740994|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|-0.039|Standard Error of the Mean|0.075||0.6009||95.0|-0.187|0.108|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740995|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|-0.084|Standard Error of the Mean|0.075||0.2635||95.0|-0.232|0.064|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1740996|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|-0.078|Standard Error of the Mean|0.11||0.4784||95.0|-0.3|0.143|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740997|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|-0.018|Standard Error of the Mean|0.109||0.8712||95.0|-0.237|0.202|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1740998|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|-0.045|Standard Error of the Mean|0.089||0.6186||95.0|-0.221|0.132|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1740999|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.093||0.4526||95.0|-0.254|0.114|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1741639|NCT00432809|3203953|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1741000|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|-0.066|Standard Error of the Mean|0.088||0.4562||95.0|-0.24|0.108|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1741001|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|-0.073|Standard Error of the Mean|0.088||0.4079||95.0|-0.247|0.101|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1741002|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|-0.117|Standard Error of the Mean|0.076||0.1251||95.0|-0.266|0.033|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1741003|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|-0.095|Standard Error of the Mean|0.077||0.2164||95.0|-0.247|0.056|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1741004|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|-0.052|Standard Error of the Mean|0.085||0.5431||95.0|-0.22|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1741005|NCT00442546|3202466|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.084||0.1949||95.0|-0.276|0.057|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1741006|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|0.127|Standard Error of the Mean|0.07||0.0734||95.0|-0.012|0.266|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1741007|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.014|Standard Error of the Mean|0.069||0.8389||95.0|-0.15|0.122|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1741008|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|0.079|Standard Error of the Mean|0.075||0.2916||95.0|-0.069|0.227|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1741009|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|0.041|Standard Error of the Mean|0.074||0.5777||95.0|-0.104|0.186|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1741010|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.026|Standard Error of the Mean|0.089||0.7663||95.0|-0.201|0.148|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1741011|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.006|Standard Error of the Mean|0.087||0.9452||95.0|-0.178|0.166|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1741012|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.081|Standard Error of the Mean|0.092||0.3774||95.0|-0.262|0.1|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1741013|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.122|Standard Error of the Mean|0.092||0.1888||95.0|-0.304|0.06|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1741014|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.135|Standard Error of the Mean|0.144||0.355||95.0|-0.426|0.156|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1741015|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.009|Standard Error of the Mean|0.144||0.9502||95.0|-0.299|0.281|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1741016|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.104||0.4417||95.0|-0.285|0.125|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1741017|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.131|Standard Error of the Mean|0.108||0.2272||95.0|-0.346|0.083|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1741018|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.128|Standard Error of the Mean|0.108||0.2399||95.0|-0.342|0.086|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1741019|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.136|Standard Error of the Mean|0.108||0.2109||95.0|-0.349|0.078|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1741020|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.149|Standard Error of the Mean|0.09||0.1005||95.0|-0.327|0.029|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1741021|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.108|Standard Error of the Mean|0.092||0.2404||95.0|-0.289|0.073|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1741022|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.048|Standard Error of the Mean|0.103||0.6406||95.0|-0.252|0.155|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1741023|NCT00442546|3202467|Superiority or Other||Mean Difference (Final Values)|-0.165|Standard Error of the Mean|0.102||0.1078||95.0|-0.367|0.036|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1741024|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|0.107|Standard Error of the Mean|0.048||0.0286||95.0|0.011|0.202|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1741025|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|0.007|Standard Error of the Mean|0.047||0.8746||95.0|-0.086|0.101|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1741026|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|0.061|Standard Error of the Mean|0.049||0.2127||95.0|-0.035|0.157|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1741027|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|0.023|Standard Error of the Mean|0.048||0.6364||95.0|-0.072|0.117|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1741028|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|0.011|Standard Error of the Mean|0.06||0.8552||95.0|-0.108|0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1741029|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|0.026|Standard Error of the Mean|0.059||0.6559||95.0|-0.09|0.143|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1741030|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|0.007|Standard Error of the Mean|0.065||0.919||95.0|-0.122|0.136|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1741640|NCT00432809|3203954|Superiority or Other|||||||0.59|||||||Wilcoxon (Mann-Whitney)||||
1741031|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|-0.036|Standard Error of the Mean|0.066||0.5802||95.0|-0.166|0.093|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1741032|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|-0.057|Standard Error of the Mean|0.085||0.507||95.0|-0.229|0.115|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1741033|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|-0.025|Standard Error of the Mean|0.084||0.7691||95.0|-0.195|0.145|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1741034|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|-0.034|Standard Error of the Mean|0.076||0.6586||95.0|-0.183|0.116|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1741035|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|-0.026|Standard Error of the Mean|0.079||0.7382||95.0|-0.183|0.13|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1741036|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|-0.028|Standard Error of the Mean|0.075||0.711||95.0|-0.176|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1741037|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|-0.023|Standard Error of the Mean|0.075||0.7628||95.0|-0.171|0.125|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1741038|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|-0.071|Standard Error of the Mean|0.069||0.3014||95.0|-0.207|0.064|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1741039|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|-0.053|Standard Error of the Mean|0.07||0.4516||95.0|-0.19|0.085|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1741040|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|-0.031|Standard Error of the Mean|0.075||0.6829||95.0|-0.178|0.117|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1741041|NCT00442546|3202468|Superiority or Other||Mean Difference (Final Values)|-0.041|Standard Error of the Mean|0.074||0.5791||95.0|-0.187|0.105|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1741042|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|0.146|Standard Error of the Mean|0.063||0.0203||95.0|0.023|0.27|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1741043|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.061||0.8659||95.0|-0.11|0.131|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 6/ET|
1741044|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.068||0.7256||95.0|-0.111|0.159|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1741045|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|0.012|Standard Error of the Mean|0.067||0.8619||95.0|-0.121|0.144|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 4|
1741046|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|0.012|Standard Error of the Mean|0.079||0.8761||95.0|-0.143|0.167|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1741047|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|0.022|Standard Error of the Mean|0.077||0.7797||95.0|-0.13|0.173|||ANOVA||Mean difference (final values) = Least squares mean difference|Week 2|
1741048|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|-0.045|Standard Error of the Mean|0.077||0.5607||95.0|-0.197|0.107|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1741049|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|-0.097|Standard Error of the Mean|0.077||0.2121||95.0|-0.249|0.056|||ANOVA||Mean difference (final values) = Least squares mean difference|Discharge|
1741050|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|-0.041|Standard Error of the Mean|0.112||0.7151||95.0|-0.266|0.184|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1741051|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.111||0.8659||95.0|-0.242|0.204|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1741052|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.094||0.8368||95.0|-0.206|0.167|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1741053|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|-0.053|Standard Error of the Mean|0.098||0.5936||95.0|-0.247|0.142|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1741054|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|-0.038|Standard Error of the Mean|0.09||0.6731||95.0|-0.215|0.139|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1741055|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|-0.057|Standard Error of the Mean|0.09||0.5271||95.0|-0.234|0.12|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1741056|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|-0.129|Standard Error of the Mean|0.082||0.1167||95.0|-0.29|0.032|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1741057|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|-0.126|Standard Error of the Mean|0.083||0.1299||95.0|-0.29|0.037|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1741058|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|-0.081|Standard Error of the Mean|0.088||0.3604||95.0|-0.254|0.093|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1741059|NCT00442546|3202469|Superiority or Other||Mean Difference (Final Values)|-0.121|Standard Error of the Mean|0.087||0.1661||95.0|-0.293|0.051|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1741060|NCT00442546|3202473|Superiority or Other||Mean Difference (Final Values)|302.9|Standard Error of the Mean|0.0|<|0.0001|2-Sided|95.0|302.9|302.9|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference||
1741061|NCT00442546|3202475|Superiority or Other||Mean Difference (Final Values)|-121.5|Standard Error of the Mean|1169.654||0.9341|2-Sided|95.0|-14983.36|14740.362|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference||
1741641|NCT00432809|3203954|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1741062|NCT00442546|3202476|Superiority or Other||Mean Difference (Final Values)|-287.032|Standard Error of the Mean|328.227||0.3948||95.0|-982.843|408.778|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 6/ET|
1741063|NCT00442546|3202476|Superiority or Other||Mean Difference (Final Values)|-256.921|Standard Error of the Mean|407.391||0.5372||95.0|-1120.551|606.709|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 6/ET|
1741064|NCT00442546|3202476|Superiority or Other||Mean Difference (Final Values)|185.728|Standard Error of the Mean|349.047||0.6024||95.0|-558.248|929.704|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 4|
1741065|NCT00442546|3202476|Superiority or Other||Mean Difference (Final Values)|198.937|Standard Error of the Mean|491.153||0.6912||95.0|-847.93|1245.804|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 4|
1741066|NCT00442546|3202476|Superiority or Other||Mean Difference (Final Values)|34.787|Standard Error of the Mean|256.969||0.8937||95.0|-501.241|570.815|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 2|
1741067|NCT00442546|3202476|Superiority or Other||Mean Difference (Final Values)|-27.291|Standard Error of the Mean|302.355||0.929||95.0|-657.992|603.41|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, Week 2|
1741068|NCT00442546|3202476|Superiority or Other||Mean Difference (Final Values)|-195.15|Standard Error of the Mean|368.958||0.6335||95.0|-1369.338|979.038|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, Week 2.|
1741069|NCT00442546|3202476|Superiority or Other||Mean Difference (Final Values)|-494.0|Standard Error of the Mean|301.253||0.1996||95.0|-1452.72|464.72|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, Week 2.|
1741070|NCT00442546|3202477|Superiority or Other||Mean Difference (Final Values)|-250.439|Standard Error of the Mean|501.808||0.6216||95.0|-1278.347|777.469|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 72 hours|
1741071|NCT00442546|3202477|Superiority or Other||Mean Difference (Final Values)|-682.304|Standard Error of the Mean|495.241||0.1792||95.0|-1696.759|332.15|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 72 hours|
1741072|NCT00442546|3202477|Superiority or Other||Mean Difference (Final Values)|105.543|Standard Error of the Mean|457.374||0.8185||95.0|-813.584|1024.67|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 48 hours|
1741073|NCT00442546|3202477|Superiority or Other||Mean Difference (Final Values)|93.693|Standard Error of the Mean|484.957||0.8476||95.0|-880.865|1068.251|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 48 hours|
1741074|NCT00442546|3202477|Superiority or Other||Mean Difference (Final Values)|-17.395|Standard Error of the Mean|384.376||0.9642||95.0|-796.945|762.155|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 24 hours|
1741075|NCT00442546|3202477|Superiority or Other||Mean Difference (Final Values)|-69.235|Standard Error of the Mean|390.483||0.8603||95.0|-861.171|722.7|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Paracetamol, 24 hours|
1741076|NCT00442546|3202477|Superiority or Other||Mean Difference (Final Values)|-1.61|Standard Error of the Mean|6.833||0.819||95.0|-17.066|13.846|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 48 hours|
1741077|NCT00442546|3202477|Superiority or Other||Mean Difference (Final Values)|-2.92|Standard Error of the Mean|9.96||0.776||95.0|-25.451|19.611|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 48 hours|
1741078|NCT00442546|3202477|Superiority or Other||Mean Difference (Final Values)|26.243|Standard Error of the Mean|44.33||0.6139||95.0|-164.494|216.98|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 24 hours|
1741079|NCT00442546|3202477|Superiority or Other||Mean Difference (Final Values)|5.771|Standard Error of the Mean|62.692||0.935||95.0|-263.972|275.515|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Ketorolac, 24 hours|
1741080|NCT00442546|3202477|Superiority or Other||Mean Difference (Final Values)|16.2|Standard Error of the Mean|142.1||0.9277||95.0|-1789.352|1821.752|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, 72 hours|
1741081|NCT00442546|3202477|Superiority or Other||Mean Difference (Final Values)|-1190.65|Standard Error of the Mean|123.062||0.0656||95.0|-2754.304|373.004|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Acetylsalicylic Acid, 72 hours|
1741082|NCT00442546|3202478|Superiority or Other||Mean Difference (Final Values)|0.909|Standard Error of the Mean|7.747||0.907||95.0|-14.593|16.411|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 6/ET|
1741083|NCT00442546|3202478|Superiority or Other||Mean Difference (Final Values)|3.65|Standard Error of the Mean|7.663||0.6356||95.0|-11.683|18.984|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 6/ET|
1741084|NCT00442546|3202478|Superiority or Other||Mean Difference (Final Values)|3.237|Standard Error of the Mean|6.361||0.6123||95.0|-9.422|15.895|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 4|
1741085|NCT00442546|3202478|Superiority or Other||Mean Difference (Final Values)|2.86|Standard Error of the Mean|6.156||0.6435||95.0|-9.392|15.111|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 4|
1741086|NCT00442546|3202478|Superiority or Other||Mean Difference (Final Values)|1.573|Standard Error of the Mean|4.637||0.7352||95.0|-7.626|10.771|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 2|
1741087|NCT00442546|3202478|Superiority or Other||Mean Difference (Final Values)|4.136|Standard Error of the Mean|4.499||0.3602||95.0|-4.79|13.062|||ANOVA||Mean Difference (Final Values) = Least Squares Mean Difference|Week 2|
1741088|NCT00442546|3202479|Superiority or Other||Mean Difference (Final Values)|-138.5|Standard Error of the Mean|37.661||0.0348||95.0|-258.354|-18.646|||ANOVA||Mean difference (final values) = Least squares mean difference|144 hours|
1741089|NCT00442546|3202479|Superiority or Other||Mean Difference (Final Values)|-40.0|Standard Error of the Mean|24.655||0.2032||95.0|-118.463|38.463|||ANOVA||Mean difference (final values) = Least squares mean difference|144 hours|
1741090|NCT00442546|3202479|Superiority or Other||Mean Difference (Final Values)|-13.325|Standard Error of the Mean|22.184||0.5552||95.0|-59.756|33.107|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1741091|NCT00442546|3202479|Superiority or Other||Mean Difference (Final Values)|-0.039|Standard Error of the Mean|17.387||0.9982||95.0|-36.431|36.352|||ANOVA||Mean difference (final values) = Least squares mean difference|120 hours|
1741092|NCT00442546|3202479|Superiority or Other||Mean Difference (Final Values)|-10.574|Standard Error of the Mean|9.283||0.2577||95.0|-29.017|7.869|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1741093|NCT00442546|3202479|Superiority or Other||Mean Difference (Final Values)|-3.356|Standard Error of the Mean|10.148||0.7416||95.0|-23.516|16.804|||ANOVA||Mean difference (final values) = Least squares mean difference|96 hours|
1741094|NCT00442546|3202479|Superiority or Other||Mean Difference (Final Values)|-4.182|Standard Error of the Mean|11.589||0.7187||95.0|-27.064|18.7|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1741095|NCT00442546|3202479|Superiority or Other||Mean Difference (Final Values)|2.759|Standard Error of the Mean|11.752||0.8147||95.0|-20.446|25.964|||ANOVA||Mean difference (final values) = Least squares mean difference|72 hours|
1741096|NCT00442546|3202479|Superiority or Other||Mean Difference (Final Values)|-28.985|Standard Error of the Mean|16.57||0.0816||95.0|-61.632|3.663|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1741097|NCT00442546|3202479|Superiority or Other||Mean Difference (Final Values)|-36.428|Standard Error of the Mean|16.517||0.0284||95.0|-68.972|-3.884|||ANOVA||Mean difference (final values) = Least squares mean difference|48 hours|
1741098|NCT00442546|3202479|Superiority or Other||Mean Difference (Final Values)|-15.548|Standard Error of the Mean|19.388||0.4234||95.0|-53.74|22.645|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1741099|NCT00442546|3202479|Superiority or Other||Mean Difference (Final Values)|-16.065|Standard Error of the Mean|19.426||0.4091||95.0|-54.332|22.203|||ANOVA||Mean difference (final values) = Least squares mean difference|24 hours|
1741100|NCT00442546|3202480|Superiority or Other||Mean Difference (Final Values)|-0.339|Standard Error of the Mean|0.371||0.3619||95.0|-1.07|0.392||A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p<0.05), then the next step conducted where the low dose group was compared to placebo.|ANOVA|Least squares means from the ANOVA model with main effects of treatment and center and Baseline mean worst pain score.|Mean difference (final values) = Least squares mean difference||
1741101|NCT00442546|3202480|Superiority or Other||Mean Difference (Final Values)|-0.038|Standard Error of the Mean|0.37||0.9185||95.0|-0.766|0.691||A step-down procedure was used for multiple comparisons adjustment. If the difference between the high dose and placebo groups was statistically significant (p<0.05), then the next step conducted where the low dose group was compared to placebo.|ANOVA|Least squares means from the analysis of variance (ANOVA) model with main effects of treatment and center and Baseline mean worst pain score.|Mean difference (final values) = Least squares mean difference||
1741102|NCT00442338|3202527|Superiority or Other||Difference in LS Means|0.02||||0.675|2-Sided|95.0|-0.06|0.09|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the LS means of time weighted average change FEV1 (0-60 min) using an ANCOVA model.|
1741103|NCT00442338|3202527|Superiority or Other||Difference in LS Means|-0.01||||0.794|2-Sided|95.0|-0.08|0.06|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the LS means of time weighted average change FEV1 (0-60 min) using an ANCOVA model.|
1741104|NCT00442338|3202527|Superiority or Other||Difference in LS Means|0.01||||0.871|2-Sided|95.0|-0.07|0.08|||ANCOVA|The model included a factor for treatment and used the baseline FEV1 as a covariate.||Treatment difference in change from Baseline in FEV1 within the first 60 minutes after study drug administration was assessed as the difference in the least square (LS) means of time weighted average change FEV1 (0-60 min) using an Analysis of Covariance (ANCOVA) model.|
1741105|NCT00442117|3202538|Superiority or Other||Mean Difference (Final Values)|0.432||||0.9622|2-Sided|95.0|-17.56|18.24|||ANOVA||||
1741106|NCT00442117|3202539|Superiority or Other||Mean Difference (Final Values)|-1.704||||0.3796|2-Sided|95.0|-5.528|2.115|||ANOVA||||
1741107|NCT00442117|3202540|Superiority or Other||Mean Difference (Final Values)|0.7601||||0.6544|2-Sided|95.0|-2.585|4.106|||ANOVA||||
1741108|NCT00442117|3202541|Superiority or Other||Mean Difference (Final Values)|-1.074||||0.4982|2-Sided|95.0|-4.196|2.049|||ANOVA||||
1741109|NCT00442013|3202542|Superiority or Other||Mean Difference (Net)|-0.8||||0.2|2-Sided|95.0|-2.1|0.4|||Regression, Linear||||
1741110|NCT00442013|3202543|Superiority or Other||Mean Difference (Net)|-0.03|Standard Error of the Mean|0.02||0.14|2-Sided|95.0|-0.07|0.01|||Regression, Linear|Model includes the data from all time points. Treatment effect (delta-delta) comparing the difference from baseline at 24 weeks is from the model.|||
1741111|NCT00442013|3202544|Superiority or Other||Risk Ratio (RR)|1.2||||0.3|2-Sided|95.0|0.9|1.7|||negative binomial||||
1741112|NCT00442013|3202545|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.0906||0.99|2-Sided|95.0|-0.1|0.1|||Regression, Linear||||
1741113|NCT00442013|3202546|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.2593||0.65|2-Sided|95.0|-0.3|0.2|||Regression, Linear||||
1741114|NCT00442013|3202547|Superiority or Other||Mean Difference (Net)|0.2|Standard Error of the Mean|0.086||0.12|2-Sided|95.0|0.0|0.3|||Regression, Linear|Linear mixed effects model is robust to data that are missing at random that has characteristics similar to multiple imputation techniques.||All participants included in the analysis. The model includes the data (ACQ scores) from all time points including baseline. The treatment effect (delta-delta) comparing the difference from baseline at 6 months is estimated from the model. Longitudinal models estimated the change from baseline to 6 months in a measurement using generalized estimating equations with an unstructured or exchangeable covariance matrix to adjust for repeated measures.|
1741115|NCT00441545|3202589|Superiority or Other|||||||0.0249|||||||ANCOVA||||
1741116|NCT00441545|3202590|Superiority or Other|||||||0.113|||||||ANCOVA||||
1741117|NCT00441116|3202713|Superiority or Other||Median Difference (Final Values)|7.54|Standard Deviation|20.37||0.0319||95.0|0.75|14.33|||t-test, 2 sided||Mean difference = Drug A minus Drug B|Month 6 - Baseline|
1741118|NCT00441103|3202716|Superiority or Other||Mean Difference (Final Values)|-1.67|Standard Deviation|2.33|<|0.001|||||||Wilcoxon signed-rank test|||Mean difference was calculated by subtracting 'Day 1 up to Week 16' from 'Week 17 up to Week 40' and analyzed using Wilcoxon signed-rank test.|
1741119|NCT00441103|3202717|Superiority or Other||||||<|0.001||||||Non-parametric analysis of variance (ANOVA) with effects for treatment and the absence/presence of Gd-enhancing lesions at baseline as factors|ANOVA||||
1741120|NCT00441012|3202729|Superiority or Other||Percentage of Seroprotected Participants|92.1||||||95.0|87.8|95.3|||||Exact binomial confidence interval|No hypothesis is being tested. The purpose of the secondary analysis is to estimate the seroprotection rate (percentage of participants with anti-PRP > 1µg/mL) in each group at 1 month after the third dose.|
1741121|NCT00441012|3202729|Superiority or Other||Percentage of Seroprotected Participants|93.9||||||95.0|90.0|96.6|||||Exact binomial confidence interval||
1741122|NCT00441012|3202731|Non-Inferiority or Equivalence|The Modified Process Vaccine is non-inferior to COMVAX with respect to anti-HBs GMT. The non-inferiority criterion requires that the lower bound of the two-sided 95% confidence interval on the ratio of the Month 11 GMTs [GMT modified process vaccine/GMT COMVAX™] is >0.67.|Geometric Mean Titer Ratio|2.5||||||95.0|1.9|3.3|||||||
1741123|NCT00441012|3202732|Superiority or Other||Percentage of Seroprotected Participants|99.1||||||95.0|69.9|99.9|||||Exact binomial confidence interval|The purpose of the primary analysis is to demonstrate that there is an adequate seroprotection rate (percentage of participants with anti-HBs >=10mIU/mL) in each group at 1 month after the third dose. An adequate response requires the lower bound of the two-sided 95% confidence interval for the seroprotection rate to exceed 90%.|
1741124|NCT00441012|3202732|Superiority or Other||Percentage of Seroprotected Participants|100.0||||||95.0|98.7|100.0|||||Exact binomial confidence interval|The purpose of the primary analysis is to demonstrate that there is an adequate seroprotection rate (percentage of participants with anti-HBs >=10mIU/mL) in each group at 1 month after the third dose. An adequate response requires the lower bound of the two-sided 95% confidence interval for the seroprotection rate to exceed 90%.|
1741125|NCT00440947|3202758|Non-Inferiority or Equivalence|Non-inferiority would be established between the two arms if the lower limit of the 2-sided 95% confidence interval (CI) on the difference in the percentage of participants with HIV-1 RNA <50 c/mL at Week 84 was -12% or greater.|Risk Difference (RD)|5.4||||0.14|2-Sided|95.0|-1.8|12.5|||Cochran-Mantel-Haenszel|p-value was obtained from Cochran-Mantel-Haenszel stratified by baseline HIV-1 RNA (<100000/>=100000)|||
1741126|NCT00440700|3202770|Superiority or Other||Slope|5.0|||<|0.05||95.0|||||Mixed Models Analysis|||Cortisol levels were compared among all 3 groups.|
1741127|NCT00440700|3202771|Superiority or Other||Mean Difference (Final Values)|1.5|Standard Error of the Mean|0.61|<|0.05|1-Sided|95.0|||||Kruskal-Wallis||Usual care was the reference comparison group.|Length of mechanical ventilatory support was assessed among all 3 groups. Usual usual care was the reference group as compared to the experimental patient-directed music group.|
1741128|NCT00440700|3202773|Superiority or Other||Slope|15.5|||<|0.05||95.0|||||Mixed Models Analysis|||Mixed models analysis was used to determine if there were any differences in anxiety levels in patients who listen to music as compared to headphones only or usual ICU care.|
1741129|NCT00440557|3202775|Superiority or Other||Difference in Percentage of Participants|-10.0||||||95.0|-18.0|-3.2|||||||
1741130|NCT00440557|3202775|Superiority or Other||Difference in Percentage of Participants|-8.8||||||95.0|-16.0|-1.9|||||||
1741131|NCT00440557|3202776|Superiority or Other||Difference of Least Squares Means|-0.07||||||95.0|-0.315|0.166|||||||
1741132|NCT00440557|3202776|Superiority or Other||Difference of Least Squares Means|0.03||||||95.0|-0.21|0.27|||||||
1741133|NCT00440557|3202777|Superiority or Other||Difference in Percentage of Participants|-3.0||||||95.0|-15.0|9.0|||||||
1741134|NCT00440557|3202777|Superiority or Other||Difference in Percentage of Participants|2.6||||||95.0|-9.6|14.8|||||||
1741135|NCT00440557|3202778|Superiority or Other||Difference in Percentage of Participants|-9.9||||||95.0|-21.7|1.8|||||||
1741136|NCT00440557|3202778|Superiority or Other||Difference in Percentage of Participants|-2.7||||||95.0|-14.2|8.7|||||||
1741137|NCT00440557|3202779|Superiority or Other||Difference in Percentage of Participants|-5.5||||||95.0|-11.4|0.3|||||||
1741138|NCT00440557|3202779|Superiority or Other||Difference in Percentage of Participants|-3.9||||||95.0|-9.5|1.6|||||||
1741139|NCT00440557|3202780|Superiority or Other||Difference of Least Squares Means|-0.45||||||95.0|-0.755|-0.147|||||||
1741140|NCT00440557|3202780|Superiority or Other||Difference of Least Squares Means|-0.26||||||95.0|-0.564|0.043|||||||
1741141|NCT00440557|3202781|Superiority or Other||Difference in Percentage of Participants|-15.0||||||95.0|-25.0|-5.0|||||||
1741142|NCT00440557|3202781|Superiority or Other||Difference in Percentage of Participants|-7.8||||||95.0|-17.2|1.7|||||||
1741143|NCT00440557|3202782|Non-Inferiority or Equivalence|Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level|Difference of Least Squares Means|-0.43|Standard Error of the Mean|0.107||||95.0|-0.641|-0.221||||||The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment through Week 22 in the Q2W group is not lower than that of the TIW group by more than 1 g/dL.|
1741144|NCT00440557|3202782|Non-Inferiority or Equivalence|Assuming a difference in the mean change in Hb from baseline to the average of the last 8 weeks of treatment through Week 22 of -0.3 g/dL between standard-tx group (TIW) and test-tx group (QW), a pooled standard deviation of 1.7 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 250 participants (125 per group) will provide 90% power to demonstrate that the test treatment group is not inferior to the standard-treatment group for an overall 2-sided 0.05 significance level|Difference of Least Squares Means|-0.17|Standard Error of the Mean|0.106||||95.0|-0.38|0.037||||||The null hypothesis is the mean change in Hb concentration from baseline to the average of the last 8 weeks of treatment (tX) through Week 22 in the QW group is not lower than that of the TIW group by more than 1 g/dL.|
1741145|NCT00440531|3202786|Superiority or Other||Single-Group Percentage|84.0||||||95.0|77.0|89.6||||||No hypothesis is being tested. The purpose of the secondary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs >=10mIU/mL) for ENGERIX-B™ at 1 month post vaccination 3, among subjects who were seronegative at baseline.|
1741146|NCT00440531|3202787|Superiority or Other||single-group percentage|68.0||||||95.0|59.8|75.5||||||No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs >=10mIU/mL) in each group at 1 month post vaccination 3, among subjects who were seronegative at baseline.|
1741147|NCT00440531|3202787|Superiority or Other||single-group percentage|75.7||||||95.0|68.0|82.2||||||No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs >=10mIU/mL) in each group at 1 month post vaccination 3, among subjects who were seronegative at baseline.|
1741148|NCT00440466|3202798|Superiority or Other||Difference in Least Squares Means|0.04|||||2-Sided|95.0|-0.206|0.289|||||||
1741149|NCT00440466|3202798|Superiority or Other||Difference in Least Squares Means|-0.08||||||95.0|-0.367|0.208|||||||
1741150|NCT00440466|3202799|Superiority or Other||Difference in percentage of participants|-3.0|||||2-Sided|95.0|-13.9|8.0|||||||
1741151|NCT00440466|3202799|Superiority or Other||Difference in percentage of participants|-3.2|||||2-Sided|95.0|-15.8|9.5|||||||
1741152|NCT00440466|3202800|Superiority or Other||Difference in percentage of participants|9.1|||||2-Sided|95.0|-2.5|20.6|||||||
1741153|NCT00440466|3202800|Superiority or Other||Difference in percentage of participants|5.7|||||2-Sided|95.0|-7.7|19.1|||||||
1741154|NCT00440466|3202801|Superiority or Other||Difference in percentage of participants|10.3||||||95.0|1.5|19.2|||||||
1741155|NCT00440466|3202801|Superiority or Other||Difference in percentage of participants|8.2|||||2-Sided|95.0|-2.0|18.3|||||||
1741156|NCT00440466|3202802|Superiority or Other||Difference in Least Squares Means|0.11|||||2-Sided|95.0|-0.098|0.32|||||||
1741157|NCT00440466|3202802|Superiority or Other||Difference in Least Squares Means|0.13|||||2-Sided|95.0|-0.113|0.372|||||||
1741158|NCT00440466|3202803|Superiority or Other||Difference in percentage of participants|1.1|||||2-Sided|95.0|-9.1|11.2|||||||
1741159|NCT00440466|3202803|Superiority or Other||Difference in percentage of participants|10.9|||||2-Sided|95.0|0.1|21.7|||||||
1741160|NCT00440466|3202805|Non-Inferiority or Equivalence|Under the same assumptions in the sample size calculation for the QW and the Q2W, 100 subjects would be needed for the Q4W. However, because Study EPO-AKD-3001 and the current study both included QW and Q2W groups, the sample size would add up to 200 for each group if combined, the sample size in the Q4W group in the current study was increased to 200 subjects in order to enroll a comparable and sufficiently large number of subjects in each of the 3 extended dosing groups across the 2 studies.|Difference of Least Squares Means|-0.09|Standard Error of the Mean|0.079|||2-Sided|95.0|-0.249|0.063||||||The null hypothesis was that the lower limit of the 95% confidence interval (CI) for the difference in mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment between the every-4-weeks (Q4W) and once-weekly (QW) groups would be lower than -1 g/dL.|
1741161|NCT00440466|3202805|Non-Inferiority or Equivalence|Assuming a difference in the mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment of -0.3 g/dL between QW and Q2W groups, a pooled standard deviation of 1.5 g/dL, and a noninferiority margin of 1 g/dL, a sample size of approximately 200 subjects (100 per group) would provide 90% power to demonstrate that Q2W group would not inferior to QW group for an overall 2-sided 0.05 significance level.|Difference of Least Squares Means|-0.03|Standard Error of the Mean|0.092|||2-Sided|95.0|-0.208|0.153||||||The null hypothesis was that the lower limit of the 95% confidence interval (CI) for the difference in mean change in hemoglobin from baseline to the average of the last 12 weeks of treatment between the every-2-weeks (Q2W) and once-weekly (QW) groups would be lower than -1 g/dL.|
1741162|NCT00440401|3202806|Superiority or Other||||||<|0.0006|||||||Cochran-Mantel-Haenszel|Normal approximation to the binominal distribution is used to construct the asymptotic confidence intervals|||
1741163|NCT00440401|3202807|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Normal approximation to the binominal distribution is used to construct the asymptotic confidence intervals|||
1741164|NCT00440297|3202812|Superiority or Other||Percentage of Seroprotected Participants|69.2||||||95.0|59.4|77.9|||||Exact binomial confidence interval||
1741165|NCT00440297|3202812|Superiority or Other||Percentage of Seroprotected Participants|66.7||||||95.0|56.5|75.8|||||Exact binomial confidence interval||
1741166|NCT00440297|3202813|Superiority or Other||Percentage of Seroprotected Participants|57.7||||||95.0|47.9|67.0|||||Exact binomial confidence interval.||
1741167|NCT00440297|3202813|Superiority or Other||Percentage of Seroprotected Participants|48.5||||||95.0|38.4|58.7|||||Exact binomial confidence interval.|No hypothesis is being tested. The purpose of the primary analysis is to estimate the seroprotection rate (percentage of subjects with anti-HBs >=10mIU/mL) in each group at 1 month after the third dose among subjects who were seronegative at baseline|
1741168|NCT00440232|3202828|Superiority or Other||log rank chi square|1.247||||0.264||95.0|||||Log Rank|df=1|||
1741169|NCT00440232|3202829|Superiority or Other||Odds Ratio (OR)|1.969||||0.172|2-Sided|95.0|0.74|5.235|||Chi-squared||||
1741170|NCT00440193|3202840|Superiority or Other||Hazard Ratio (HR)|0.97|Standard Error of the Mean|0.1204||0.77||95.0|0.76|1.22||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.||
1741171|NCT00440193|3202842|Superiority or Other||Hazard Ratio (HR)|0.67|Standard Error of the Mean|0.1828||0.027||95.0|0.47|0.95||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.||
1741172|NCT00440193|3202843|Superiority or Other||Hazard Ratio (HR)|0.72|Standard Error of the Mean|0.1616||0.044||95.0|0.53|0.99||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.||
1741499|NCT00433654|3203833|Non-Inferiority or Equivalence|Non-inferiority margin is 10%.|Difference in percentages|2.1|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group <= success rate control group - 10%|
1741173|NCT00440193|3202844|Non-Inferiority or Equivalence|Assuming equal efficacy, a total of 88 events was calculated to give a power of 90% to prove that rivaroxaban is at least as effective as the comparator, considering a non-inferiority upper CI margin for the hazard ratio of 2.0 (two-sided α=0.05). A mean incidence for the primary efficacy outcome of 3% was expected and at least 1465 participants per group were determined to be necessary. This number was to be adjusted based on the observed overall incidence of symptomatic recurrent VTE.|Hazard Ratio (HR)|0.68|Standard Error of the Mean|0.2179|<|0.0001||95.0|0.44|1.04|||Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing). Based on this model, rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI was less than 2.0.|
1741174|NCT00440115|3202848|Superiority|Power calculations indicated that 250 participants per group would have 80% power to compare high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.|Odds Ratio (OR)|1.33||||0.18|2-Sided|95.0|0.88|2.02|||Mixed Models Analysis||High-intensity disease management vs moderate-intensity disease management||
1741175|NCT00440115|3202848|Superiority|Power calculations demonstrated that 250 participants per group would have 95% power to compare combined high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.|Odds Ratio (OR)|1.12||||0.54|2-Sided|95.0|0.78|1.61|||Mixed Models Analysis||(High-intensity disease management and moderate-intensity disease management) vs pharmacotherapy management||
1741176|NCT00440011|3202859|Superiority or Other|||||||0.024|||||||ANCOVA||||
1741177|NCT00439946|3202861|Superiority or Other|||||||0.52||||||p-value for TSQM Global Satisfaction Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741178|NCT00439946|3202861|Superiority or Other|||||||0.01||||||p-value for TSQM Convenience Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741179|NCT00439946|3202861|Superiority or Other|||||||0.5||||||p-value for TSQM Side-Effects Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741180|NCT00439946|3202861|Superiority or Other|||||||0.55||||||p-value for TSQM Effectiveness Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741181|NCT00439946|3202862|Superiority or Other|||||||0.22||||||p-value for CAMPHOR Total Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741182|NCT00439946|3202862|Superiority or Other|||||||0.03||||||p-value for CAMPHOR Quality of Life Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741183|NCT00439946|3202862|Superiority or Other|||||||0.84||||||p-value for CAMPHOR Activity Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741184|NCT00439946|3202862|Superiority or Other|||||||0.31||||||p-value for: CAMPHOR Symptom Score|Wilcoxon signed rank|||Changes in mean TSQM and CAMPHOR scores between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741185|NCT00439946|3202863|Superiority or Other|||||||0.11||||||p-value for: Total time|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741186|NCT00439946|3202863|Superiority or Other|||||||0.48||||||p-value for: Change dressing|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741187|NCT00439946|3202863|Superiority or Other|||||||0.2||||||p-value for: Connect drug|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741188|NCT00439946|3202863|Superiority or Other|||||||0.02||||||p-value for: Prepare drug|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741189|NCT00439946|3202863|Superiority or Other|||||||0.95||||||p-value for: Gather/set-up|Wilcoxon signed rank|||Changes in mean times between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741190|NCT00439946|3202864|Superiority or Other|||||||1|||||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values|
1741191|NCT00439946|3202865|Superiority or Other|||||||1|||||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values|
1741192|NCT00439946|3202866|Superiority or Other|||||||0.75|||||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values|
1741193|NCT00439946|3202867|Superiority or Other|||||||1|||||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values|
1741194|NCT00439946|3202868|Superiority or Other|||||||0.5|||||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values|
1741195|NCT00439946|3202869|Superiority or Other|||||||1|||||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values|
1741196|NCT00439946|3202870|Superiority or Other|||||||0.5|||||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values|
1741197|NCT00439946|3202871|Superiority or Other|||||||1|||||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741198|NCT00439946|3202872|Superiority or Other|||||||1|||||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741199|NCT00439946|3202873|Superiority or Other|||||||0.84|||||||Wilcoxon signed rank|||Changes between Baseline and Week 8 were assessed using the Wilcoxon signed rank test, comparing the values at Baseline to values at Week 8. A two-sided p value of < 0.05 was considered statistically significant. No imputation was used for missing values.|
1741200|NCT00439777|3202884|Superiority or Other||Hazard Ratio (HR)|0.9|Standard Error of the Mean|0.08756||0.23|2-Sided|95.0|0.76|1.07||If the primary efficacy analysis shows that rivaroxaban is non-inferior to the comparator, the principal safety outcome was to be compared between treatment groups to maintain the overall type I error of 0.05 (2-sided) (a closed testing procedure).|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.||
1741201|NCT00439777|3202885|Superiority or Other||Hazard Ratio (HR)|0.94|Standard Error of the Mean|0.3289||0.85|2-Sided|95.0|0.49|1.79||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.||
1741202|NCT00439777|3202886|Superiority or Other||Hazard Ratio (HR)|1.16|Standard Error of the Mean|0.257||0.55|2-Sided|95.0|0.7|1.93||nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|The standard error of the log hazard ratio was estimated.||
1741203|NCT00439777|3202887|Superiority or Other||Hazard Ratio (HR)|0.85|Standard Error of the Mean|0.1499||0.275|2-Sided|95.0|0.63|1.14||Nominal p-value|Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.||
1741204|NCT00439777|3202888|Superiority or Other||Hazard Ratio (HR)|1.16|Standard Error of the Mean|0.15||0.33|2-Sided|95.0|0.86|1.56||Nominal p-value|Regression, Cox||The standard error of the log hazard ratio was estimated.|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline.|
1741205|NCT00439777|3202889|Non-Inferiority or Equivalence|Assuming equal efficacy, a total of 88 events will give a power of 90% to demonstrate that rivaroxaban is at least as effective as the comparator, considering a relative non-inferiority upper CI margin for the hazard ratio of 2.0 (two-sided alpha=0.05). The mean overall incidence for the primary efficacy outcome of 3% was expected and therefore 1465 patients per group would be needed. This number was to be adjusted based on the observed overall incidence of symptomatic recurrent VTE.|Hazard Ratio (HR)|1.12|Standard Error of the Mean|0.2067||0.0026|2-Sided|95.0|0.75|1.68|||Regression, Cox|Stratified by intend treatment duration, adjusted for presence of active malignancy at baseline|The standard error of the log hazard ratio was estimated.|The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing). Based on this model, rivaroxaban would be considered at least as effective as the comparator if the upper limit of the CI was less than 2.0.|
1741206|NCT00439725|3202909|Superiority or Other||Hazard Ratio (HR)|5.185|Standard Error of the Mean|0.4131|<|0.0001||95.0|2.307|11.652||No adjustment for multiple comparison, a p-value of less than 0.05 would be considered significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment done for treatment-emergent (time window: 2 days)||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing), comparison was done for the treatment emergent (within two days after end of treatment) bleeding events.|
1741207|NCT00439725|3202910|Superiority or Other|||||||0.1121||||||No adjustment for multiple comparison.|Log Rank|||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing), comparison was done for the treatment emergent (within two days after end of treatment) bleeding events.|
1741642|NCT00432809|3203954|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1741208|NCT00439725|3202913|Superiority or Other||Hazard Ratio (HR)|0.278|Standard Error of the Mean|0.3274|<|0.0001||95.0|0.146|0.528||4th test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the previous tests in hierarchy were significant|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).|
1741209|NCT00439725|3202914|Superiority or Other||Hazard Ratio (HR)|0.198|Standard Error of the Mean|0.3659|<|0.0001||95.0|0.096|0.405||3rd test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the previous tests in hierarchy were significant|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).|
1741210|NCT00439725|3202915|Superiority or Other||Hazard Ratio (HR)|0.18|Standard Error of the Mean|0.385|<|0.0001||95.0|0.085|0.383||2nd test in a hierarchy, a p-value of less than 0.05 would be considered significant. If the 1st test in hierarchy was significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (two-sided testing).|
1741211|NCT00439725|3202916|Superiority or Other||Hazard Ratio (HR)|0.185|Standard Error of the Mean|0.3858|<|0.0001||95.0|0.087|0.393||1st test in a hierarchy, a p-value of less than 0.05 would be considered significant.|Regression, Cox|Stratified by intended treatment duration, adjusted for pre-treatment||The rivaroxaban to comparator hazard ratio was computed with a 95% CI (confidence interval) (two-sided testing).|
1741212|NCT00439517|3202950|Superiority or Other||Hazard Ratio (HR)|0.977||||0.8575|2-Sided|95.0|0.755|1.263|||Stratified log rank||Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||
1741213|NCT00439517|3202951|Superiority or Other||Hazard Ratio (HR)|0.855||||0.3797|2-Sided|95.0|0.603|1.213|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|||
1741214|NCT00439517|3202952|Superiority or Other||Odds Ratio (OR)|1.756||||0.016|2-Sided|95.0|1.11|2.777|||Cochran-Mantel-Haenszel|Stratified odds ratio and Cochran-Mantel- Haenszel (CMH) statistics were calculated considering the randomization strata.|||
1741215|NCT00439517|3202953|Superiority or Other||Hazard Ratio (HR)|0.677||||0.0048|2-Sided|95.0|0.515|0.889|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|||
1741216|NCT00439374|3202963|Superiority or Other|||||||0.61|||||||Wilcoxon (Mann-Whitney)||||
1741217|NCT00439374|3202971|Superiority or Other|||||||0.82|||||||Wilcoxon (Mann-Whitney)||||
1741218|NCT00439374|3202972|Superiority or Other||Risk Ratio (RR)|0.77|||||2-Sided|95.0|0.46|1.3||||||Analysis is for the total composite|
1741219|NCT00439374|3202973|Superiority or Other||Risk Ratio (RR)|0.7|||||2-Sided|95.0|0.27|1.83||||||Nausea|
1741220|NCT00439374|3202973|Superiority or Other||Risk Ratio (RR)|5.03|||||2-Sided|95.0|1.11|22.78||||||Urticaria|
1741221|NCT00439374|3202973|Superiority or Other||Risk Ratio (RR)|1.04|||||2-Sided|95.0|0.93|1.17||||||Injection site|
1741222|NCT00439374|3202973|Superiority or Other||Risk Ratio (RR)|1.02|||||2-Sided|95.0|0.92|1.13||||||Any side effect|
1741223|NCT00439374|3202974|Superiority or Other||Risk Ratio (RR)|1.07|||||2-Sided|95.0|0.79|1.46|||||||
1741224|NCT00439374|3202975|Superiority or Other||Risk Ratio (RR)|1.45|||||2-Sided|95.0|0.84|2.52|||||||
1741225|NCT00439374|3202976|Superiority or Other||Risk Ratio (RR)|0.74|||||2-Sided|95.0|0.34|1.58|||||||
1741226|NCT00439374|3202978|Superiority or Other||Risk Ratio (RR)|1.16|||||2-Sided|95.0|0.56|2.41|||||||
1741227|NCT00439374|3202979|Superiority or Other||Risk Ratio (RR)|1.16|||||2-Sided|95.0|0.78|1.72|||||||
1741228|NCT00439374|3202980|Superiority or Other||Risk Ratio (RR)|1.52|||||2-Sided|95.0|0.43|5.33|||||||
1741229|NCT00439374|3202981|Superiority or Other||Risk Ratio (RR)|1.09|||||2-Sided|95.0|0.77|1.55|||||||
1741230|NCT00439374|3202982|Superiority or Other||Risk Ratio (RR)|0.84|||||2-Sided|95.0|0.55|1.29|||||||
1741231|NCT00439374|3202983|Superiority or Other||Risk Ratio (RR)|0.97|||||2-Sided|95.0|0.82|1.15|||||||
1741232|NCT00439374|3202984|Superiority or Other||Risk Ratio (RR)|0.69|||||2-Sided|95.0|0.36|1.3|||||||
1741233|NCT00439374|3202985|Superiority or Other||Risk Ratio (RR)|0.88|||||2-Sided|95.0|0.54|1.43|||||||
1741234|NCT00439374|3202986|Superiority or Other||Risk Ratio (RR)|0.84|||||2-Sided|95.0|0.58|1.21|||||||
1741235|NCT00439374|3202987|Superiority or Other||Risk Ratio (RR)|1.05|||||2-Sided|95.0|0.61|1.8|||||||
1741236|NCT00439374|3202988|Superiority or Other|||||||0.93|||||||Wilcoxon (Mann-Whitney)||||
1741237|NCT00439374|3202989|Superiority or Other||Risk Ratio (RR)|1.09|||||2-Sided|95.0|0.65|1.84||||||Medically-indicated deliveries|
1741238|NCT00439374|3202989|Superiority or Other||Risk Ratio (RR)|0.99|||||2-Sided|95.0|0.7|1.4||||||Spontaneous deliveries|
1741239|NCT00439374|3202989|Superiority or Other||Risk Ratio (RR)|1.03|||||2-Sided|95.0|0.79|1.35||||||All deliveries less than 37 weeks|
1741240|NCT00439309|3203003|Superiority or Other|||||||0.404|||||||Log Rank|Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group|||
1741241|NCT00439309|3203004|Superiority or Other|||||||0.089|||||||t-test, 2 sided||||
1741242|NCT00439309|3203005|Superiority or Other|||||||0.654|||||||t-test, 2 sided|p-value for superiority of the Vascular Sealant System compared to the GELFOAMTreatment from two-sided test based on the GEE regression model|||
1741243|NCT00439309|3203006|Superiority or Other|||||||0.006|||||||t-test, 2 sided|p-value for superiority of the Vascular Sealant System compared to the GELFOAM Treatment from two-sided test based on the GEE regression model.|||
1741289|NCT00438399|3203139|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.|
1741500|NCT00433654|3203834|Non-Inferiority or Equivalence|Non-inferiority margin is 10%.|Difference in percentages|1.9|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group <= success rate control group - 10%|
1741244|NCT00439309|3203007|Non-Inferiority or Equivalence|The sealing success rates for the investigational group and control groups were assumed to be 0.85 (85%) and 0.75 (75%), respectively, and the non-inferiority margin (10%) is 0.10. For safety reasons it was desired to have at least 100 Vascular Sealant treated subjects. It was determined that a sample size of at least 31 evaluable subjects is required for the control group. For blocking purposes, the number of evaluable control group subjects was set to 33, for a 3:1 randomization.||||||0.072|||||||Z-Test|one-sided Z-test based on the normal approximation to the binomial distribution testing||The effectiveness analyses were performed on the ITT population.|
1741245|NCT00438854|3203065|Superiority or Other||Estimating proportion of responders|0.2||||||||||||||The primary measures of efficacy of tumor response were: complete remission (CR), nodular partial remission (nPR), or partial remission (PR), as per NCI-WG criteria. The true ORR is reported as percentage and 90% CI calculated using the binomial exact test. Time to treatment failure (TTF) was defined from the date on study to date of progression, death in remission, initiation of non-protocol therapy in the absence of progression, or censored on the last visit.|
1741246|NCT00438659|3203093|Superiority or Other|||||||0.18|||||||t-test, 2 sided||||
1741247|NCT00438464|3203103|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Caspase, Within Placebo Arm|
1741248|NCT00438464|3203103|Superiority or Other||||||<|0.9|||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within Placebo Arm|
1741249|NCT00438464|3203103|Superiority or Other||||||<|0.91|||||||Wilcoxon (Mann-Whitney)|||SRD5A2, Within Placebo Arm|
1741250|NCT00438464|3203103|Superiority or Other||||||<|0.87|||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within Placebo Arm|
1741251|NCT00438464|3203103|Superiority or Other||||||<|0.77|||||||Wilcoxon (Mann-Whitney)|||AR, Within Placebo Arm|
1741252|NCT00438464|3203103|Superiority or Other||||||<|0.83|||||||Wilcoxon (Mann-Whitney)|||ERβ, Within Placebo Arm|
1741253|NCT00438464|3203103|Superiority or Other||||||<|0.32|||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within Placebo Arm|
1741254|NCT00438464|3203104|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Caspase, Within Finasteride Arm|
1741255|NCT00438464|3203104|Superiority or Other||||||<|0.18|||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within Finasteride Arm|
1741256|NCT00438464|3203104|Superiority or Other||||||<|0.88|||||||Wilcoxon (Mann-Whitney)|||SRD5A2, Within Finasteride Arm|
1741257|NCT00438464|3203104|Superiority or Other||||||<|0.46|||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within Finasteride Arm|
1741258|NCT00438464|3203104|Superiority or Other||||||<|0.09|||||||Wilcoxon (Mann-Whitney)|||AR, Within Finasteride|
1741259|NCT00438464|3203104|Superiority or Other||||||<|0.36|||||||Wilcoxon (Mann-Whitney)|||ERβ, Within Finasteride Arm|
1741260|NCT00438464|3203104|Superiority or Other||||||<|0.84|||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within Finasteride Arm|
1741261|NCT00438464|3203109|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Caspase, Within GG4|
1741262|NCT00438464|3203109|Superiority or Other|||||||0.86|||||||Wilcoxon (Mann-Whitney)|||UBE2C, Within GG4|
1741263|NCT00438464|3203109|Superiority or Other|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG4|
1741264|NCT00438464|3203109|Superiority or Other|||||||0.8|||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within GG4|
1741265|NCT00438464|3203109|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Androgen receptor (AR), Within GG4|
1741266|NCT00438464|3203109|Superiority or Other|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Estrogen receptor beta (ERβ), Within GG4|
1741267|NCT00438464|3203109|Superiority or Other|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||Vascular Epithelial Growth Factor (VEGF3), Within GG4|
1741268|NCT00438464|3203110|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Cleaved Caspase 3 (Caspase), Within GG3|
1741269|NCT00438464|3203110|Superiority or Other|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||Ubiquitin-conjugating enzyme E2C (UBE2C), Within GG3|
1741270|NCT00438464|3203110|Superiority or Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)|||3-oxo-5α-steroid 4-dehydrogenase 2 (SRD5A2), Within GG3|
1741271|NCT00438464|3203110|Superiority or Other|||||||0.75|||||||Wilcoxon (Mann-Whitney)|||Ki-67 protein, Within GG3|
1741272|NCT00438464|3203110|Superiority or Other|||||||0.41|||||||Wilcoxon (Mann-Whitney)|||Androgen receptor (AR), Within GG3|
1741273|NCT00438464|3203110|Superiority or Other|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Estrogen receptor beta (ERβ), Within GG3|
1741274|NCT00438464|3203110|Superiority or Other|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||VEGF3, Within GG3|
1741275|NCT00438464|3203111|Superiority or Other|||||||0.254|||||||Wilcoxon (Mann-Whitney)||||
1741276|NCT00438464|3203112|Superiority or Other|||||||0.805|||||||Wilcoxon (Mann-Whitney)||||
1741277|NCT00438464|3203113|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1741278|NCT00438464|3203114|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)||||
1741279|NCT00438464|3203115|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1741280|NCT00438451|3203134|Superiority or Other|||||||0.5022|||||||Log Rank||||
1741281|NCT00438451|3203135|Superiority or Other|||||||0.3303|||||||Fisher Exact||||
1741282|NCT00438451|3203136|Superiority or Other|||||||0.2517|||||||Fisher Exact||||
1741283|NCT00438451|3203137|Superiority or Other|||||||0.0596|||||||Log Rank||||
1741284|NCT00438451|3203138|Superiority or Other||Odds Ratio (OR)|1.838||||0.0578|2-Sided|95.0|1.092|3.093|||Regression, Logistic|adjusted for treatment (p=0.0578), country (p=0.4649), pooled sites (p=0.4420) and number of concurrent diseases (p=0.0192)|"Odds ratio given here is for comparison LEV vs CBZ: OR=1.838 KI=(1.092-3.093) LEV vs LTG: OR=1.169 KI=(0.689-1.984) CBZ vs LTG: OR=0.636 KI=(0.377-1.073) Number of concurrent diseases: OR=0.921 KI=(0.859-0.987)"||
1741285|NCT00438451|3203138|Superiority or Other|||||||0.0478|||||||Fisher Exact||||
1741286|NCT00438451|3203138|Superiority or Other|||||||0.3615|||||||Fisher Exact||||
1741287|NCT00438451|3203138|Superiority or Other|||||||0.1536|||||||Fisher Exact||||
1741288|NCT00438451|3203138|Superiority or Other|||||||0.0201|||||||Fisher Exact||||
1741643|NCT00432809|3203955|Superiority or Other|||||||0.17|||||||Wilcoxon (Mann-Whitney)||||
1741290|NCT00438399|3203139|Superiority or Other||||||<|0.007|||||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.|
1741291|NCT00438399|3203139|Superiority or Other||||||<|0.0003|||||||Wilcoxon (Mann-Whitney)|||The purpose of the study was to demonstrate the superiority of Clobetasol propionate shampoo over one of three other comparators, in terms of Subject's overall preference. It was to be analyzed using a non parametric two-sided Wilcoxon rank Signed test on ITT population.|
1741292|NCT00437658|3203184|Other||Least squares mean|-17.9|||<|0.0001|2-Sided|95.0|-23.1|-12.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741293|NCT00437658|3203184|Other||Least squares mean|-23.4|||<|0.0001|2-Sided|95.0|-28.3|-18.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in monthly mean VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741294|NCT00437658|3203184|Other||Least squares mean|-18.2|||<|0.0001|2-Sided|95.0|-23.3|-13.1||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in monthly mean VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741295|NCT00437658|3203185|Other||Least squares mean|-35.8|||<|0.0001|2-Sided|95.0|-43.0|-28.6||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741296|NCT00437658|3203185|Other||Least squares mean|-32.9|||<|0.0001|2-Sided|95.0|-39.4|-26.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741297|NCT00437658|3203185|Other||Least squares mean|-32.3|||<|0.0001|2-Sided|95.0|-39.2|-25.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in peak VAS for pelvic pain at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741298|NCT00437658|3203186|Other||Least squares mean|-0.8|||<|0.0001|2-Sided|95.0|-0.9|-0.6|||t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741299|NCT00437658|3203186|Other||Least squares mean|-0.9|||<|0.0001|2-Sided|95.0|-1.1|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741300|NCT00437658|3203186|Other||Least squares mean|-0.9|||<|0.0001|2-Sided|95.0|-1.0|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic induration at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741301|NCT00437658|3203187|Other||Least squares mean|-0.9|||<|0.0001|2-Sided|95.0|-1.1|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741302|NCT00437658|3203187|Other||Least squares mean|-1.0|||<|0.0001|2-Sided|95.0|-1.1|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741336|NCT00437125|3203252|Superiority or Other||||||<|0.0001||||||p-value is for 4 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 4-week endpoint.|
1741644|NCT00432809|3203955|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1741645|NCT00432809|3203955|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1741303|NCT00437658|3203187|Other||Least squares mean|-1.0|||<|0.0001|2-Sided|95.0|-1.2|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in pelvic tenderness at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741304|NCT00437658|3203188|Other||Least squares mean|-1.1|||<|0.0001|2-Sided|95.0|-1.3|-0.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|
1741305|NCT00437658|3203188|Other||Least squares mean|-1.2|||<|0.0001|2-Sided|95.0|-1.4|-1.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|
1741306|NCT00437658|3203188|Other||Least squares mean|-1.2|||<|0.0001|2-Sided|95.0|-1.4|-1.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in non-menstrual pelvic pain at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|
1741307|NCT00437658|3203189|Other||Least squares mean|-0.8|||<|0.0001|2-Sided|95.0|-1.1|-0.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741308|NCT00437658|3203189|Other||Least squares mean|-1.0|||<|0.0001|2-Sided|2.0|-1.2|-0.7||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741309|NCT00437658|3203189|Other||Least squares mean|-1.2|||<|0.0001|2-Sided|95.0|-1.4|-0.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dyspareunia at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741310|NCT00437658|3203190|Other||Least squares mean|-1.7|||<|0.0001|2-Sided|95.0|-1.9|-1.4||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741311|NCT00437658|3203190|Other||Least squares mean|-1.4|||<|0.0001|2-Sided|95.0|-1.6|-1.2||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741312|NCT00437658|3203190|Other||Least squares mean|-1.5|||<|0.0001|2-Sided|95.0|-1.7|-1.2||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in dysmenorrhea at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741313|NCT00437658|3203191|Other||Least squares mean|-4.5|||<|0.0001|2-Sided|95.0|-5.1|-3.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|
1741314|NCT00437658|3203191|Other||Least squares mean|-4.4|||<|0.0001|2-Sided|95.0|-5.0|-3.9||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|
1741315|NCT00437658|3203191|Other||Least squares mean|-4.6|||<|0.0001|2-Sided|95.0|-5.1|-4.0||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS excluding dyspareunia at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|
1741316|NCT00437658|3203192|Other||Least squares mean|-5.3|||<|0.0001|2-Sided|95.0|-6.0|-4.6||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||"Within-group analysis of change from baseline in total CPSSS at week 24.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction."|
1741317|NCT00437658|3203192|Other||Least squares mean|-5.2|||<|0.0001|2-Sided|95.0|-5.8|-4.5||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in total CPSSS at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741318|NCT00437658|3203192|Other||Least squares mean|-5.5|||<|0.0001|2-Sided|95.0|-6.2|-4.8||P-value for test of null hypothesis that the treatment group least squares mean is equal to zero.|t-test, 2 sided|||Within-group analysis of change from baseline in total CPSSS at week 24. Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction.|
1741319|NCT00437658|3203195|Non-Inferiority|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|0.5||||0.9544|2-Sided|95.0|-15.1|16.0|||Pearson chi-squared||Difference in response rates = elagolix - DMPA-SC||
1741320|NCT00437658|3203195|Non-Inferiority|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|9.5||||0.2048|2-Sided|95.0|-5.2|24.2|||Pearson chi-squared||Difference in response rates = elagolix - DMPA-SC||
1741321|NCT00437658|3203196|Non-Inferiority|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|-12.4||||0.101|2-Sided|95.0|-26.7|1.8|||Pearson chi-squared||Difference in response rate = elogolix - DMPA-SC||
1741322|NCT00437658|3203196|Non-Inferiority|Statistical non-inferiority was defined when the lower bound of the 95% 2-sided confidence interval for the difference between an elagolix dose and DMPA-SC in the response rate was no less than -20% at week 24 for both dysmenorrhea and non-menstrual pelvic pain.|Difference in response rates|-0.3||||0.963|2-Sided|95.0|-13.4|12.7|||Pearson chi-squared||Difference in response rate = elogolix - DMPA-SC||
1741323|NCT00437645|3203206|Non-Inferiority or Equivalence|Statistical analysis for non-inferiority of valsartan/amlodipine 160/5 mg to amlodipine 10 mg alone with a non-inferiority margin of 3 mm Hg|Mean Difference (Final Values)|-1.72|Standard Error of the Mean|0.65|||2-Sided|95.0|-3.0|-0.44|||||||
1741324|NCT00437125|3203246|Superiority or Other||||||<|0.0001||||||p-value is for PDQ-39 total score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in PDQ-39 total score.|
1741325|NCT00437125|3203247|Superiority or Other||||||<|0.0001||||||p-value is for VAS pain while awake score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS pain while awake score.|
1741326|NCT00437125|3203247|Superiority or Other||||||<|0.0001||||||p-value is for VAS interference score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS interference score.|
1741327|NCT00437125|3203247|Superiority or Other||||||<|0.0001||||||p-value is for VAS shoulder pain score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS shoulder pain score.|
1741328|NCT00437125|3203247|Superiority or Other||||||<|0.0001||||||p-value is for VAS back ache score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS back ache scores.|
1741329|NCT00437125|3203247|Superiority or Other||||||<|0.0002||||||p-value is for VAS Headaches score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS headaches scores.|
1741330|NCT00437125|3203247|Superiority or Other||||||<|0.0027||||||p-value is for VAS overall pain score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change from baseline to 12 weeks in VAS overall pain scores.|
1741331|NCT00437125|3203248|Superiority or Other||||||<|0.0001||||||p-value is for BDI score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no difference between baseline and post-baseline in BDI scores|
1741332|NCT00437125|3203250|Superiority or Other||||||<|0.0001||||||p-value is for Clinical Global Impression-Severity scale - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Clinical Global Impression-Severity scale score from baseline to end of week 12 of treatment.|
1741333|NCT00437125|3203251|Superiority or Other||||||<|0.0001||||||p-value is for the HAMD-17 total score. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the HAMD-17 total score from baseline to 12-week endpoint.|
1741334|NCT00437125|3203252|Superiority or Other||||||<|0.0001||||||p-value is for 12 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 12-week endpoint.|
1741335|NCT00437125|3203252|Superiority or Other||||||<|0.0001||||||p-value is for 8 weeks change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the Pittsburgh Sleep Quality Index from baseline to 8-week endpoint.|
1741337|NCT00437125|3203253|Superiority or Other|||||||0.0263||||||p-value is for global assessment by doctor. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the global assessment by doctor subscale score from baseline to 12-week endpoint.|
1741338|NCT00437125|3203253|Superiority or Other|||||||0.0848||||||p-value is for global assessment by paticipant. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the global assessment by paticipant subscale score from baseline to 12-week endpoint.|
1741339|NCT00437125|3203253|Superiority or Other|||||||0.5586||||||p-value is for other subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total other subscale score from baseline to 12-week endpoint.|
1741340|NCT00437125|3203253|Superiority or Other|||||||0.0014||||||p-value is for autonomic subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total autonomic subscale score from baseline to 12-week endpoint.|
1741341|NCT00437125|3203253|Superiority or Other||||||<|0.0001||||||p-value is for neurological subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total neurological subscale score from baseline to 12-week endpoint.|
1741342|NCT00437125|3203253|Superiority or Other||||||<|0.0001||||||p-value is for psychic subscale. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total psychic subscale score from baseline to 12-week endpoint.|
1741343|NCT00437125|3203254|Superiority or Other|||||||0.5553||||||p-value is for total UDPRS score - change. A priori threshold for p-values was 0.05.|t-test, 2 sided|||Tested was the null hypothesis that there would be no change on the total UDPRS score from baseline to 12-week endpoint.|
1741344|NCT00437125|3203255|Superiority or Other||Percentage|8.6|||||1-Sided|95.0||13.3|||||||
1741345|NCT00437073|3203267|Superiority or Other||percentage of participants|38.0|||||2-Sided|95.0|13.9|68.4|||||The estimated value indicates the percentage of participants with CNS OR in the Lapatinib plus Capecitabine treatment arm.||
1741346|NCT00436969|3203284|Superiority or Other||Adjusted Mean Difference|0.467||||0.671|2-Sided|95.0|-1.692|2.627||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.|
1741347|NCT00436969|3203285|Superiority or Other||Adjusted Mean Difference|-0.018||||0.988|2-Sided|95.0|-2.314|2.278||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.|
1741348|NCT00436969|3203286|Superiority or Other||Adjusted Mean Difference|0.771||||0.473|2-Sided|95.0|-1.339|2.881||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.|
1741349|NCT00436969|3203287|Superiority or Other||Adjusted Mean Difference|1.19||||0.333|2-Sided|95.0|-1.225|3.604||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.|
1741350|NCT00436969|3203288|Superiority or Other||Adjusted Mean Difference|1.22||||0.267|2-Sided|95.0|-0.937|3.378||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.|
1741351|NCT00436969|3203289|Superiority or Other||Adjusted Mean Difference|0.068||||0.957|2-Sided|95.0|-2.396|2.532||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.|
1741352|NCT00436969|3203290|Superiority or Other||Adjusted Mean Difference|-0.228||||0.832|2-Sided|95.0|-2.343|1.887||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.|
1741353|NCT00436969|3203291|Superiority or Other||Adjusted Mean Difference|-1.558||||0.232|2-Sided|95.0|-4.119|1.003||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.|
1741424|NCT00435461|3203517|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|0.18|<|0.001|2-Sided|95.0|-1.6|-0.9|||ANCOVA||||
1741354|NCT00436969|3203292|Superiority or Other||Adjusted Mean Difference|-2.208||||0.409|2-Sided|95.0|-7.455|3.039||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.|
1741355|NCT00436969|3203293|Superiority or Other||Adjusted Mean Difference|2.617||||0.379|2-Sided|95.0|-3.226|8.46||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.|
1741356|NCT00436969|3203294|Superiority or Other||Adjusted Mean Difference|-2.79||||0.41|2-Sided|95.0|-9.441|3.861||The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.|
1741357|NCT00436969|3203295|Superiority or Other||Adjusted Mean Difference|2.361||||0.369|2-Sided|95.0|-2.801|7.522||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.|
1741358|NCT00436969|3203296|Superiority or Other||Adjusted Mean Difference|7.317||||0.018|2-Sided|95.0|1.249|13.386||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative (Ha) is that the effect of the two treatment groups at 6 months is unequal.|
1741359|NCT00436969|3203297|Superiority or Other||Adjusted Mean Difference|1.13||||0.685|2-Sided|95.0|-4.341|6.001||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.|
1741360|NCT00436969|3203298|Superiority or Other||Adjusted Mean Difference|-0.82||||0.79|2-Sided|95.0|-6.866|5.227||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.|
1741361|NCT00436969|3203299|Superiority or Other||Adjusted Mean Difference|1.028||||0.707|2-Sided|95.0|-4.338|6.393||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.|
1741362|NCT00436969|3203300|Superiority or Other||Adjusted Mean Difference|-0.932||||0.772|2-Sided|95.0|-7.26|5.396||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.|
1741363|NCT00436969|3203301|Superiority or Other||Adjusted Mean Difference|-2.875||||0.392|2-Sided|95.0|-9.472|3.723||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.|
1741364|NCT00436969|3203302|Superiority or Other||Adjusted Mean Difference|-0.87||||0.827|2-Sided|95.0|-8.698|6.957||The p-value was not adjusted for multiple comparisons. The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||The null hypothesis (Ho) is that the effect of the two treatment groups at 12 weeks is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups is unequal.|
1741365|NCT00436969|3203303|Superiority or Other||Mean Difference (Final Values)|-5.3|||||2-Sided|95.0|-19.7|9.1||||||Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.|
1741425|NCT00435461|3203518|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.14||0.816|2-Sided|95.0|-0.3|0.2|||ANCOVA||||
1741646|NCT00432809|3203956|Superiority or Other|||||||0.98|||||||ANOVA||||
1741366|NCT00436969|3203304|Superiority or Other||Mean Difference (Final Values)|-0.2|||||2-Sided|95.0|-15.6|15.1||||||Asymptotic 95% confidence interval for the treatment group difference (Orthovisc - Control) in proportions of responders was calculated. The null hypothesis (Ho) is that the effect of the two treatment groups at 6 months is equal and the corresponding alternative hypothesis (Ha) is that the effect of the two treatment groups at 6 months is unequal.|
1741367|NCT00436969|3203305|Superiority or Other||Adjusted Mean Difference|-1.472||||0.696|2-Sided|95.0|-8.888|5.943||The a priori threshold for significance was a two-sided p <0.05.|Mixed Models Repeated Measures ANCOVA|The analysis included baseline score as a covariate. Site was dropped from the model due to statistical insignificance.||Anticipated VAS difference of 10 mm and SD of 25 mm indicated a sample size of 225 subjects in a 2:1 randomization would provide 80% power to detect a significant difference with a two-sided significance level of 5%. To account for a 15% dropout rate the sample size was increased to 270 subjects (180 Orthovisc, 90 control). The primary null hypothesis (Ho) no difference in VAS means at 6 months and the alternative hypothesis (Ha) was that Orthovisc (mean VAS) is superior to the control.|
1741368|NCT00436917|3203324|Superiority or Other (legacy)|||||||0.01|||||||Kruskal-Wallis|||A sample of 60 participants was estimated to provide percentage statistics accuracy to within 13% with 95% confidence.|
1741369|NCT00436826|3203341|Superiority or Other||Relative Risk|0.38|||<|0.001|2-Sided|95.0|0.23|0.65|||Wald Chi-square||||
1741370|NCT00436748|3203359|Superiority or Other|||||||0.293|||||||Exact|||The null hypothesis for the Darbepoetin Alfa Q2W group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p > 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.|
1741371|NCT00436748|3203359|Superiority or Other||||||<|0.001|||||||Exact|||The null hypothesis for the Darbepoetin Alfa QW group was that the correction proportion (p) ≤ 0.8 ; Th alternative hypothesis was that p > 0.8. The correction proportion was compared with 0.8 using the exact method to test the null hypothesis at a 1-sided overall significance level of 0.025.|
1741372|NCT00435994|3203466|Superiority or Other|||||||0.002|||||||ANOVA||||
1741373|NCT00435994|3203467|Superiority or Other|||||||0.002|||||||ANOVA||||
1741374|NCT00435942|3203469|Non-Inferiority or Equivalence|The proportion of subjects in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.|Proportion free|0.97|||>|0.8|1-Sided|97.5|0.93||||1-sided z-test|97.5% 1-sided confidence interval||The proportion of subjects in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.|
1741375|NCT00435929|3203479|Superiority or Other||Geometric mean ratio|0.844|||||2-Sided|90.0|0.551|1.292||||||Comparison between normal liver function and moderate hepatic impairment for RTV.|
1741376|NCT00435929|3203479|Superiority or Other||Geometric Mean Ratio|0.716|||||2-Sided|90.0|0.311|1.644||||||Comparison between normal liver function and moderate hepatic impairment for SQV.|
1741377|NCT00435929|3203480|Superiority or Other||Geometric mean ratio|0.764|||||2-Sided|90.0|0.505|1.156||||||Comparison between normal liver function and moderate hepatic impairment for RTV.|
1741378|NCT00435929|3203480|Superiority or Other||Geometric mean ratio|0.656|||||2-Sided|90.0|0.268|1.603||||||Comparison between normal liver function and moderate hepatic impairment for SQV|
1741379|NCT00435591|3203500|Superiority or Other||Least Squares Mean Difference|0.23|||||2-Sided|95.0|-0.37|0.83||||||Aggregated data were used to determine differences between groups. Statistical analysis is relevant to the aggregated data of all rows except the “no assessment” row.|
1741380|NCT00435539|3203501|Superiority or Other|||||||0.5343|||||||Fisher Exact||||
1741381|NCT00435539|3203501|Superiority or Other|||||||0.4762|||||||Fisher Exact||||
1741382|NCT00435539|3203501|Superiority or Other|||||||0.4762|||||||Fisher Exact||||
1741383|NCT00435539|3203502|Superiority or Other|||||||0.0721|||||||Fisher Exact||||
1741384|NCT00435539|3203502|Superiority or Other|||||||0.0932|||||||Fisher Exact||||
1741385|NCT00435539|3203502|Superiority or Other|||||||0.4783|||||||Fisher Exact||||
1741386|NCT00435487|3203505|Superiority or Other||Difference in proportion|-0.05||||1||95.0|-6.05|5.95|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).|
1741387|NCT00435487|3203506|Superiority or Other||Difference in proportion|-0.05||||1||95.0|-6.05|5.95|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).|
1741388|NCT00435487|3203507|Superiority or Other||Difference in proportion|1.27||||1||95.0|-1.2|3.73|||Chi-squared||95% CI is for difference in proportion using normal approximation to binomial.|Difference in proportion (Dalteparin-UFH)(%).|
1741389|NCT00435487|3203508|Non-Inferiority or Equivalence|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|-1.35||||||95.0|-8.62|5.93|||||95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Death or Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).|
1741426|NCT00435461|3203518|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-1.2|-0.7|||ANCOVA||||
1741427|NCT00435461|3203518|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.14|<|0.001|2-Sided|95.0|-1.2|-0.7|||ANCOVA||||
1741501|NCT00433654|3203835|Non-Inferiority or Equivalence|Non-inferiority margin is 10%.|Difference in percentages|0.5|||<|0.001||95.0|||||Farrington-Manning|||Null hypothesis: success rate MRI group <= success rate control group - 10%|
1741390|NCT00435487|3203508|Non-Inferiority or Equivalence|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|1.25||||||95.0|-3.02|5.52|||||95% CI is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Non-fatal Myocardial Infarction after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).|
1741391|NCT00435487|3203508|Non-Inferiority or Equivalence|The test of non-inferiority was based on whether the upper limit of the two-sided 95% confidence interval for the treatment group difference was less than or equal to 10%, the non-inferiority margin specified in the protocol.|Difference in proportion|-2.6||||||95.0|-8.59|3.4|||||95% confidence interval (CI) is for difference in proportion using normal approximation to binomial. Non-inferiority was concluded if the upper boundary of the 95% CI for the Dalteparin - Unfractioned Heparin difference was less than or equal to 10%.|Death after receiving 48 hours of study medication (Event date - First dose date) and on or before day 30 from baseline. Difference in proportion (Dalteparin-UFH)(%).|
1741392|NCT00435461|3203509|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|-0.8|-0.4|||ANCOVA||||
1741393|NCT00435461|3203509|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.11|<|0.203|2-Sided|95.0|-0.4|0.1|||ANCOVA||||
1741394|NCT00435461|3203509|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|-0.7|-0.3|||ANCOVA||||
1741395|NCT00435461|3203510|Superiority or Other||Mean Difference (Final Values)|0.7|Standard Error of the Mean|1.65||0.662|2-Sided|95.0|-2.5|4.0|||ANCOVA|||Evening assessment|
1741396|NCT00435461|3203510|Superiority or Other||Mean Difference (Final Values)|7.0|Standard Error of the Mean|1.65|<|0.001|2-Sided|95.0|3.8|10.3|||ANCOVA|||Evening assessment|
1741397|NCT00435461|3203510|Superiority or Other||Mean Difference (Final Values)|6.3|Standard Error of the Mean|1.65|<|0.001|2-Sided|95.0|3.1|9.6|||ANCOVA|||Evening assessment|
1741398|NCT00435461|3203510|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|1.59|<|0.779|2-Sided|95.0|-3.6|2.7|||ANCOVA|||Morning assessment|
1741399|NCT00435461|3203510|Superiority or Other||Mean Difference (Final Values)|8.4|Standard Error of the Mean|1.59|<|0.001|2-Sided|95.0|5.3|11.5|||ANCOVA|||Morning assessment|
1741400|NCT00435461|3203510|Superiority or Other||Mean Difference (Final Values)|8.8|Standard Error of the Mean|1.59|<|0.001|2-Sided|95.0|5.7|11.9|||ANCOVA|||Morning assessment|
1741401|NCT00435461|3203511|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.15||0.16|2-Sided|95.0|-0.5|0.0|||ANCOVA|||Pre-dose iTOSS|
1741402|NCT00435461|3203511|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.15||0.058|2-Sided|95.0|-0.6|0.0|||ANCOVA|||Pre-dose iTOSS|
1741403|NCT00435461|3203511|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.15|<|0.001|2-Sided|95.0|-0.8|-0.2|||ANCOVA|||Pre-dose iTOSS|
1741404|NCT00435461|3203511|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.18|<|0.193|2-Sided|95.0|-0.6|0.1|||ANCOVA|||Pre-dose iTNSS|
1741405|NCT00435461|3203511|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.18|<|0.001|2-Sided|95.0|-1.4|-0.7|||ANCOVA|||Pre-dose iTNSS|
1741406|NCT00435461|3203511|Superiority or Other||Mean Difference (Final Values)|-1.3|Standard Error of the Mean|0.18|<|0.001|2-Sided|95.0|-1.7|-1.0|||ANCOVA|||Pre-dose iTNSS|
1741407|NCT00435461|3203512|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.15||0.106|2-Sided|95.0|-0.6|0.0|||ANCOVA||||
1741408|NCT00435461|3203512|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.15||0.286|2-Sided|95.0|-0.5|0.1|||ANCOVA||||
1741409|NCT00435461|3203512|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.15||0.003|2-Sided|95.0|-0.7|-0.2|||ANCOVA||||
1741410|NCT00435461|3203513|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.15||0.106|2-Sided|95.0|-0.5|0.1|||ANCOVA||||
1741411|NCT00435461|3203513|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.15||0.286|2-Sided|95.0|-0.5|0.1|||ANCOVA||||
1741412|NCT00435461|3203513|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.15||0.007|2-Sided|95.0|-0.7|-0.1|||ANCOVA||||
1741413|NCT00435461|3203514|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.15||0.286|2-Sided|95.0|-0.5|0.1|||ANCOVA||||
1741414|NCT00435461|3203514|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.15||0.106|2-Sided|95.0|-0.6|0.0|||ANCOVA||||
1741415|NCT00435461|3203514|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.15||0.001|2-Sided|95.0|-0.8|-0.2|||ANCOVA||||
1741416|NCT00435461|3203515|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.18||0.136|2-Sided|95.0|-0.6|0.1|||ANCOVA||||
1741417|NCT00435461|3203515|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.18|<|0.001|2-Sided|95.0|-1.3|-0.6|||ANCOVA||||
1741418|NCT00435461|3203515|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.18|<|0.001|2-Sided|95.0|-1.6|-0.8|||ANCOVA||||
1741419|NCT00435461|3203516|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.19||0.136|2-Sided|95.0|-0.7|0.1|||ANCOVA||||
1741420|NCT00435461|3203516|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.19|<|0.001|2-Sided|95.0|-1.2|-0.4|||ANCOVA||||
1741421|NCT00435461|3203516|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.19|<|0.001|2-Sided|95.0|-1.5|-0.7|||ANCOVA||||
1741422|NCT00435461|3203517|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.18||0.136|2-Sided|95.0|-0.6|0.1|||ANCOVA||||
1741423|NCT00435461|3203517|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.18|<|0.001|2-Sided|95.0|-1.4|-0.7|||ANCOVA||||
1741428|NCT00435409|3203523|Superiority or Other||Hazard Ratio (HR)|1.0372||||0.6275|2-Sided|95.0|0.8322|1.2927||Stratification factors (all from IVRS) included number of metastatic organ sites (<=2 vs >2 sites), hormone receptor status (HER2—/ER—/PR— vs all others), and prior chemotherapy regimens (1 vs >1).|Log Rank||Hazard ratio for sunitinib + capecitabine versus capecitabine.||
1741429|NCT00435409|3203525|Superiority or Other||Odds Ratio (OR)|1.32||||0.1269|2-Sided|95.0|0.83|2.13||A stratified CMH test stratified by randomization stratification factors was used to compare ORR between two treatment arms.|Cochran-Mantel-Haenszel|||Investigator's assessment|
1741430|NCT00435409|3203525|Superiority or Other||Odds Ratio (OR)|1.17||||0.3143|2-Sided|95.0|0.69|1.97||A stratified CMH test stratified by randomization stratification factors was used to compare objective response rate (ORR) between two treatment arms.|Cochran-Mantel-Haenszel|||Independent radiology assessment|
1741431|NCT00435409|3203526|Superiority or Other||Hazard Ratio (HR)|1.1084||||0.812|2-Sided|95.0|0.8817|1.3935||Stratification factors include metastatic organ sites (2 or less versus [vs] 2 or more sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs more than 1), from IVRS.|Log Rank|||A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors|
1741432|NCT00435409|3203526|Superiority or Other||Hazard Ratio (HR)|1.2239||||0.9409|2-Sided|95.0|0.9487|1.5789||Stratification factors included metastatic organ sites (2 or less versus [vs] more than [>] 2 sites), hormone receptor status (HER2-/ER-/PR-) vs all others), and prior chemotherapy regimens (1 vs >1), from interactive voice response system (IVRS).|Log Rank|||A stratified log-rank test (1-sided, α=0.025) based on randomization stratification factors|
1741433|NCT00435370|3203527|Superiority or Other||||||<|0.05|||||||ANCOVA||||
1741434|NCT00435188|3203528|Superiority or Other|||||||0.08|||||||Mixed Models Analysis|||P value provides the overall differences between groups at the end of the study|
1741435|NCT00435188|3203531|Superiority or Other|||||||0.35|||||||Mixed Models Analysis|||P value provides overall differences between groups at the end of the study|
1741436|NCT00435188|3203534|Superiority or Other|||||||0.29|||||||Mixed Models Analysis|||Omnibus P value provides the overall difference between groups at the end of the study|
1741437|NCT00435188|3203537|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Omnibus P value provides the overall differences between groups at the end of the study|
1741438|NCT00435188|3203538|Superiority or Other|||||||0.04|||||||Mixed Models Analysis|||Omnibus P value for overall difference between groups at the end of the study and group by time interaction on two degrees of freedom|
1741439|NCT00435188|3203541|Superiority or Other|||||||0.47|||||||Mixed Models Analysis|||Omnibus P value reporting overall differences between groups for group and group by time interaction with two degrees of freedom|
1741440|NCT00435188|3203544|Superiority or Other||||||<|0.001||||||Omnibus p value for group difference between groups at the end of the study and group by time interaction|Mixed Models Analysis||||
1741441|NCT00435162|3203549|Superiority or Other||Slope|-1.05||||0.099|2-Sided|95.0|-2.31|0.2|||Regression, Linear|||Slope change across all 3 active treatment groups.|
1741442|NCT00435045|3203574|Non-Inferiority or Equivalence|Non-inferiority of the non-HDL-C response was assessed by calculating the 2-sided 90% and 95% confidence intervals (CIs)for each difference in response based on comparing the effects of increases in atorvastatin dose on the percent changes from baseline to the end of each atorvastatin period, a repeated-ANOVA model was used.||||||0.0002|||||||ANOVA||||
1741443|NCT00435019|3203577|Non-Inferiority or Equivalence|The null hypothesis for the non-inferiority test was that the mean HbA1c with insulin detemir was greater than or equal to the mean HbA1c with NPH insulin plus 0.4%. A sample size of 344 subjects, in total, with a drop-out rate of 20 percent would yield 274 subjects for evaluation of HbA1c. This would give 85 percent power to detect a difference in means of HbA1c of 0.4 percentage points assuming that the standard deviation was 1.1 using a two-sided t-test with a 0.05 significance level.|Mean Difference (Final Values)|0.12||||||95.0|-0.12|0.36|||||||
1741444|NCT00434993|3203579|Superiority or Other||Risk Difference (RD)|9.5||||0.265|2-Sided|95.0|-6.9|25.9|||Regression, Logistic||||
1741445|NCT00434993|3203580|Superiority or Other||Mean Difference (Final Values)|-3.9||||0.048|2-Sided|95.0|-7.8|0.0|||ANCOVA||||
1741446|NCT00434993|3203581|Superiority or Other||Risk Difference (RD)|8.2||||0.176|2-Sided|95.0|-3.1|19.6|||Regression, Logistic|Adjusted for baseline shock.|||
1741447|NCT00434993|3203582|Superiority or Other||Mean Difference (Final Values)|-2.3||||0.13|2-Sided|95.0|-5.3|0.6|||ANCOVA|Adjusted for baseline shock.|||
1741448|NCT00434993|3203583|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.226|2-Sided|95.0|-4.3|0.9||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.|||
1741449|NCT00434993|3203584|Superiority or Other||Mean Difference (Final Values)|-2.7||||0.023|2-Sided|95.0|-4.9|-0.4||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.|||
1741450|NCT00434993|3203585|Superiority or Other||Risk Difference (RD)|5.9||||0.261|2-Sided|95.0|-3.7|15.4||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|Adjusted for baseline shock.|||
1741451|NCT00434993|3203586|Superiority or Other||Risk Difference (RD)|5.3||||0.302|2-Sided|95.0|-4.0|14.7||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|Adjusted for baseline shock.|||
1741452|NCT00434993|3203587|Superiority or Other||Mean Difference (Final Values)|-2.2|Standard Error of the Mean|1.3||0.087|2-Sided|95.0|-4.7|0.3||The p-value was not adjusted for multiple comparisons.|ANCOVA|Adjusted for baseline shock.||The trial had a statistical power of 90.7% to detect a 2.25-day increase in VFDs,assuming a SD of 10.5 days. A group sequential design was used.|
1741453|NCT00434954|3203598|Superiority or Other||||||<|0.0001||||||The MMRM model adjusted for baseline HbA1c stratum (HbA1c at Visit 1 >= 6.5% and <= 8.0% vs. > 8.0% and <=10%).|Mixed effects model repeated measures|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects)|||
1741454|NCT00434954|3203599|Superiority or Other||||||<|0.0001||||||The MMRM model adjusted for baseline HbA1c stratum (HbA1c at baseline >= 6.5% and <= 8.0% vs. > 8.0% and <=10%).|Mixed effects model repeated measures|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects)|||
1741647|NCT00432809|3203956|Superiority or Other|||||||0.001|||||||ANOVA||||
1741455|NCT00434954|3203600|Superiority or Other||||||<|0.05||||||Non overlapping 95% CI's: statistically significant difference p<0.05.|Kaplan-Meier analysis|For each treatment group, the incidence of hypoglycemia at Week 26 and 95% CIs were derived from Kaplan-Meier analysis.||The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart BID for glycemic control (outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2).The planned sample size of 366 patients treated with metformin only (assumed dropout rate 25%) gave 96% power to detect superiority of exenatide BID for the risk of hypoglycemia, assuming incidences of 3.6% for exenatide BID and 17.5% for insulin aspart BID (alpha=0.05).|
1741456|NCT00434954|3203605|Superiority or Other|||||||0.159|||||||Chi square test (Pearson)||||
1741457|NCT00434954|3203606|Superiority or Other|||||||0.554|||||||Chi square test (Pearson)||||
1741458|NCT00434954|3203607|Non-Inferiority or Equivalence|The planned sample size of 366 patients treated with metformin only (assuming 25% dropouts) gave a power of 85% to detect non-inferiority of exenatide BID for change in HbA1c (non-inferiority margin 0.4%; assumed common standard deviation of 1.1%).|Mean Difference (Net)|0.14||||0.055|2-Sided|95.0|-0.003|0.291||Non-inferiority: upper limit of 95% Confidence Interval (CI) to be < 0.4%.|Mixed effect model repeat measures(MMRM)|95% CI of treatment group difference derived from MMRM (treatment, week, baseline HbA1c and interactions as fixed effects); p-value: superiority test||The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart 70/30 BID for glycemic control (change in HbA1c, outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2). This is the first part of the hierarchical test.|
1741459|NCT00434876|3203608|Superiority or Other|||||||0.03|||||||Mixed Models Analysis||||
1741460|NCT00434876|3203609|Superiority or Other|||||||0.57|||||||Mixed Models Analysis||||
1741461|NCT00434876|3203610|Superiority or Other|||||||0.04|||||||Mixed Models Analysis||||
1741462|NCT00434876|3203611|Superiority or Other|||||||0.49|||||||Mixed Models Analysis||||
1741463|NCT00434759|3203612|Superiority or Other||Mean Difference (Final Values)|6.86|||<|0.05||95.0||||priori threshold for statistical significance ist 0.05 p-value ist nor adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is significant (p < .05) in favour of standard therapy||
1741464|NCT00434759|3203613|Superiority or Other||Mean Difference (Final Values)|3.43|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value ist not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction is not significant.||
1741465|NCT00434759|3203614|Superiority or Other||Mean Difference (Final Values)|0.99|||<|0.05||95.0||||p-value is not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is not significant.||
1741466|NCT00434759|3203615|Superiority or Other||Mean Difference (Final Values)|1.24|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value ist not adjusted for multiple comparisons|ANOVA|we report the interaction effect|The reported interaction effect is not significant.||
1741467|NCT00434759|3203616|Superiority or Other||Mean Difference (Final Values)|5.82|||<|0.05||95.0||||priori threshold for statistical significance is 0.05 p-value is not adjusted for multiple comparisons|ANOVA|We report the interaction effect.|The reported interaction effect is significant (p< .05) in favour of standard therapy.||
1741468|NCT00434642|3203619|Superiority or Other||Hazard Ratio (HR)|0.952||||0.6479|2-Sided|95.0|0.771|1.176||Summaries of duration of overall survival (median, percentiles) were estimated from Kaplan-Meier curves. The 95% confidence interval for the median was computed using the method of Brookmeyer and Crowley.|Log Rank|The analysis was stratified for time since the last platinum therapy (≤12, >12 months) and cytoreductive surgery for recurrent disease (Yes, No).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.||
1741469|NCT00434642|3203621|Superiority or Other||Mean Difference (Final Values)|21.1|||<|0.0001|2-Sided|95.0|13.0|29.2||A P-value < 0.05 was required for significance.|Cochran-Mantel-Haenszel|The analysis was stratified for time since the last platinum therapy (6-12, > 12 months) and cytoreductive surgery for recurrent disease (yes, no).|The difference in response rates and the 95% confidence intervals for response rates were computed using the normal approximation to the binomial distribution.|The null hypothesis was that there was no difference in the percentage of patients with an objective response between the 2 treatment groups. The alternative hypothesis was that a larger percentage of patients had an objective response in the carboplatin and gemcitabine + bevacizumab group.|
1741470|NCT00434642|3203622|Superiority or Other||Hazard Ratio (HR)|0.484|||<|0.0001|2-Sided|95.0|0.388|0.605||A P-value < 0.05 was required for significance.|Log Rank|The analysis was stratified for time since the last platinum therapy (6-12, > 12 months) and cytoreductive surgery for recurrent disease (yes, no).|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the carboplatin and gemcitabine + placebo group.|The null hypothesis was that there was no difference between the 2 treatment groups, ie, that the hazard ratio is equal to 1. The alternative hypothesis was that progression free survival was longer in the carboplatin and gemcitabine + bevacizumab group, ie, that the hazard ratio is not equal to 1.|
1741471|NCT00434434|3203677|Superiority or Other|||||||0.0028|||||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney|||
1741472|NCT00434434|3203677|Superiority or Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney|||
1741473|NCT00434434|3203678|Superiority or Other|||||||0.0133|||||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney|||
1741474|NCT00434434|3203678|Superiority or Other|||||||0.13|||||||Wilcoxon (Mann-Whitney)|exact Wilcoxon-Mann-Whitney|||
1741475|NCT00434252|3203725|Superiority or Other||Difference in event rates|12.2||||0.0982||95.0|-2.3|26.6|||z-test|z-test using the standard errors computed using Greenwood's method|||
1741476|NCT00434252|3203726|Superiority or Other||Difference in survival rates|3.5||||0.5724||95.0|-8.7|15.7|||z-test|z-test using the standard errors computed using Greenwood's method.|||
1741477|NCT00434161|3203740|Superiority or Other||Hazard Ratio, log|0.84||||0.372|2-Sided|95.0|0.58|1.23|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.|
1741478|NCT00434161|3203741|Superiority or Other||Hazard Ratio (HR)|0.8||||0.236|2-Sided|95.0|0.55|1.16|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.|
1741479|NCT00434161|3203742|Superiority or Other||Mean Difference (Final Values)|17.417|||||2-Sided|95.0|-11.086|45.919|||||||
1741480|NCT00434161|3203743|Superiority or Other||Hazard Ratio (HR)|0.64||||0.192|2-Sided|95.0|0.33|1.26|||Log Rank|||All comparisons for the long-term safety endpoints were based on the combined palifermin group (pre- and post- high dose chemotherapy and pre-high dose chemotherapy only) versus placebo (placebo over palifermin). Overall survival was analyzed using the Kaplan-Meier method. Kaplan-Meier estimates were provided together with the 95% confidence interval.|
1741481|NCT00434161|3203745|Superiority or Other||Risk Difference (RD)|5.951|||||2-Sided|95.0|-0.679|12.58|||||||
1741482|NCT00434161|3203746|Superiority or Other||Risk Difference (RD)|-3.689|||||2-Sided|95.0|-21.641|14.264|||||||
1741483|NCT00434161|3203747|Superiority or Other||Mean Difference (Final Values)|0.061|||||2-Sided|95.0|-0.138|0.26|||||||
1741484|NCT00434161|3203748|Superiority or Other||Mean Difference (Net)|0.023|||||2-Sided|95.0|-0.134|0.181|||||||
1741485|NCT00434161|3203750|Superiority or Other||Risk Difference (RD)|5.88|||||2-Sided|95.0|-21.669|33.43|||||||
1741486|NCT00434161|3203751|Superiority or Other||Mean Difference (Final Values)|5.331||||0.806|2-Sided|97.5|-11.82|22.482||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test||||
1741487|NCT00434161|3203751|Superiority or Other||Mean Difference (Final Values)|15.436||||0.142|2-Sided|97.5|-1.542|32.415||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||For the secondary endpoints, the type I error rate was protected by using the Hochberg procedure to adjust for multiple testing16. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.|
1741488|NCT00434161|3203752|Superiority or Other||Mean Difference (Final Values)|-0.213|Standard Deviation|6.13||0.806|2-Sided|97.5|-2.575|2.15||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test||||
1741489|NCT00434161|3203752|Superiority or Other||Mean Difference (Final Values)|2.409|Standard Deviation|6.82||0.095|2-Sided|97.5|0.07|4.748||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|van Elteren test|||A type I error rate was protected by using the Hochberg procedure to adjust for multiple testing. Palifermin was not to be declared to be statistically superior to placebo with respect to secondary efficacy endpoints unless the primary endpoint was statistically significant in favor of palifermin.|
1741490|NCT00434161|3203753|Superiority or Other||Risk Difference (RD)|-2.014||||0.806|2-Sided|97.5|-20.519|16.491||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|Cochran-Mantel-Haenszel||||
1741491|NCT00434161|3203753|Superiority or Other||Risk Difference (RD)|13.262||||0.245|2-Sided|97.5|-4.303|30.828||For secondary endpoints the type I error was protected by using the Hochberg procedure. The reported p-values are adjusted by the Hochberg procedure.|Cochran-Mantel-Haenszel||||
1741492|NCT00434161|3203754|Superiority or Other||Odds Ratio (OR)|1.242||||0.468|2-Sided|97.5|0.635|2.431||A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.|Proportional odds model|The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.|The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.|The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.|
1741493|NCT00434161|3203754|Superiority or Other||Odds Ratio (OR)|0.679||||0.188|2-Sided|97.5|0.351|1.313||A 2.5% type I error rate for each comparison gives an overall type I error rate of 5%.|Proportional odds model|The proportional odds model including the randomization factors as covariates was used for the primary endpoint, maximum severity of OM.|The odds ratio was defined to be the odds of a subject receiving placebo experiencing OM divided by the odds of a subject receiving palifermin developing OM.|The null hypothesis was that the severity distribution for OM was identical for the placebo and each of the two palifermin groups, and the alternative hypothesis was that palifermin resulted in a shift in the distribution to less severe mucositis than placebo. A total of 275 subjects would give at least 95% power, with a 2.5% type I error rate for each comparison to detect an odds ratio of at least 3.5 between the placebo group and each of the two palifermin groups.|
1741494|NCT00434057|3203780|Superiority or Other|||||||0.02|||||||Chi-squared|||Specificty of MelaFind and examining dermatologists on the same set of pigmented skin lesions.|
1741495|NCT00434057|3203780|Superiority or Other||Sensitivity to melanoma|98.0||||0.05||95.0|95.1|100.0|||exact mid-P||"Of 127 melanomas, 114 melanomas had a pre-biopsy diagnosis of Melanoma can not be ruled out or Not melanoma, which qualified them for primary endpoint analysis of sensitivity. MelaFind correctly identified 112/114 melanomas."|MelaFind's sensitivity to cutaneous melanoma and 95% confidence intervals were determined.|
1741496|NCT00434018|3203786|Superiority or Other|||||||0.001|||||||ANOVA||||
1741497|NCT00433836|3203806|Non-Inferiority or Equivalence|non-inferiority delta of 3.5 mm Hg|Mean Difference (Final Values)|-1.3|||||2-Sided|95.0|-3.8|1.17|||||||
1741498|NCT00433654|3203832|Superiority or Other||Percentage|8.3|||<|0.001|1-Sided|95.0||10.7|||exact test of binomial proportions|||Null hypothesis: Percentage of subjects with complication > 20%|
1741502|NCT00433654|3203836|Non-Inferiority or Equivalence|Non-inferiority margin is 10%.|Difference in percentages|0.0||||||95.0||||||||Null hypothesis: success rate MRI group <= success rate control group - 10%|
1741504|NCT00433511|3203847|Superiority||Hazard Ratio (HR)|0.9||||0.36|2-Sided|95.0|0.72|1.13||Two-sided; based on stratified test using stratification factors at randomization|Regression, Cox||Hazard ratio: Arm C/Arm B||
1741505|NCT00433511|3203847|Superiority||Hazard Ratio (HR)|1.01||||0.92|2-Sided|95.0|0.77|1.33||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm B/Arm A||
1741506|NCT00433511|3203847|Superiority||Hazard Ratio (HR)|0.89||||0.41|2-Sided|95.0|0.68|1.17||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm C/Arm A||
1741507|NCT00433511|3203848|Superiority||Hazard Ratio (HR)|0.87||||0.17|2-Sided|95.0|0.71|1.06||Two-sided; based on stratified test using stratification factors at randomization.|Regression, Cox||Hazard ratio: Arm C/Arm A|The primary objective of this trial was to determine whether the addition of bevacizumab improved IDFS. A two-step hierarchical approach was used. In the 1st step, Arm C was to be compared to Arm A. If Arm C significantly improved IDFS relative to Arm A, then in the 2nd step, a comparison of Arm B to Arm A was to be performed. If the treatment in both Arm C and Arm B significantly improved IDFS relative to Arm A, then a comparison of Arm C to Arm B was to be performed with respect to IDFS.|
1741508|NCT00433381|3203860|Other|Specificity|Specificity|0.78|||||2-Sided|95.0|0.66|0.87||||||Specificity|
1741509|NCT00433381|3203860|Other|Sensitivity|Sensitivity|0.6|||||2-Sided|95.0|0.46|0.73||||||Sensitivity|
1741510|NCT00433381|3203861|Other|Agreement was assessed using a Kappa statistic|Kappa Statistic|0.39|||||2-Sided|95.0|0.21|0.57||||||Agreement between Local and Central determinations 6-month PFS, based on imaging, was evaluated using Kappa statistics|
1741511|NCT00433381|3203863|Other||||||||||||||||||The determination of treatment efficacy was to be made made based on the following rules: If 16 or more of the cases (16/57=28.1%) are progression free and alive at 6 months, then reject the null hypothesis that the rate is no better than 20%. If 15 or fewer of the cases (15/57=26.3%) are progression free and alive at 6 months, then reject the alternative hypothesis that the rate is at least 35%.
1741512|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|1.0|||||2-Sided|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 16 weeks|
1741513|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.89|||||2-Sided|95.0|0.63|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 16 weeks|
1741514|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|1.0|||||2-Sided|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 16 weeks|
1741515|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.78|||||2-Sided|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 8 weeks|
1741516|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.5|||||2-Sided|95.0|0.13|0.87||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 8 weeks|
1741517|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.58|||||2-Sided|95.0|0.22|0.95||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 8 weeks|
1741518|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.5|||||2-Sided|95.0|0.06|0.94||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cr at 2 weeks|
1741519|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.72|||||2-Sided|95.0|0.36|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery Cho/Cr at 2 weeks|
1741520|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.6|||||2-Sided|95.0|0.2|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of periphery NAA/Cho at 2 weeks|
1741521|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.57|||||2-Sided|95.0|0.03|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 16 weeks|
1741522|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.73|||||2-Sided|95.0|0.19|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 16 weeks|
1741523|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.8|||||2-Sided|95.0|0.45|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 16 weeks|
1741524|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.6|||||2-Sided|95.0|0.17|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 8 weeks|
1741525|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.78|||||2-Sided|95.0|0.44|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 8 weeks|
1741526|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.8|||||2-Sided|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 8 weeks|
1741527|NCT00433381|3203864|Other|ROC analysis|Accuracy: Area Under the ROC|0.67|||||2-Sided|95.0|0.25|1.0||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cr at 2 weeks|
1741528|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.42|||||2-Sided|95.0|0.0|0.88||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor Cho/Cr at 2 weeks|
1741529|NCT00433381|3203864|Other|ROC analysis|Area Under the Curve (AUC)|0.42|||||2-Sided|95.0|0.0|0.92||||||AUC (Accuracy) estimate for the prediction of 12 month overall survival by change in metabolic ratio of tumor NAA/Cho at 2 weeks|
1741530|NCT00433381|3203865|Other|ROC analysis|Area Under the Curve (AUC)|0.93|||||2-Sided|95.0|0.73|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 16 weeks|
1741531|NCT00433381|3203865|Other|ROC analysis|Area Under the Curve (AUC)|1.0|||||2-Sided|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 16 weeks|
1741532|NCT00433381|3203865|Other|ROC analysis|Area Under the Curve (AUC)|1.0|||||2-Sided|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 16 weeks|
1741533|NCT00433381|3203865|Other|ROC analysis|Area Under the Curve (AUC)|0.63|||||2-Sided|95.0|0.22|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 8 weeks|
1741534|NCT00433381|3203865|Other|ROC analysis|Area Under the Curve (AUC)|0.41|||||2-Sided|95.0|0.01|0.8||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 8 weeks|
1741535|NCT00433381|3203865|Other|ROC analysis|Area Under the Curve (AUC)|0.47|||||2-Sided|95.0|0.02|0.92||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 8 weeks|
1741536|NCT00433381|3203865|Other|ROC analysis|Area Under the Curve (AUC)|0.54|||||2-Sided|95.0|0.06|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cr at 2 weeks|
1741537|NCT00433381|3203865|Other|ROC analysis|Area Under the Curve (AUC)|0.52|||||2-Sided|95.0|0.13|0.91||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery Cho/Cr at 2 weeks|
1741538|NCT00433381|3203865|Other|ROC analysis|Area Under the Curve (AUC)|0.39|||||2-Sided|95.0|0.0|0.88||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of periphery NAA/Cho at 2 weeks|
1741539|NCT00433381|3203865|Other|ROC analysis|Area Under the Curve (AUC)|0.46|||||2-Sided|95.0|0.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 16 weeks|
1741540|NCT00433381|3203865|Other|ROC analysis|Area Under the Curve (AUC)|1.0|||||2-Sided|95.0|1.0|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 16 weeks|
1741541|NCT00433381|3203865|Other||Area Under the Curve (AUC)|0.75|||||2-Sided|95.0|0.21|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 16 weeks|
1741542|NCT00433381|3203865|Other||Area Under the Curve (AUC)|0.6|||||2-Sided|95.0|0.11|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 8 weeks|
1741543|NCT00433381|3203865|Other||Area Under the Curve (AUC)|0.83|||||2-Sided|95.0|0.47|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 8 weeks|
1741544|NCT00433381|3203865|Other||Area Under the Curve (AUC)|0.85|||||2-Sided|95.0|0.53|1.0||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 8 weeks|
1741545|NCT00433381|3203865|Other|ROC analysis|Area Under the Curve (AUC)|0.46|||||2-Sided|95.0|0.0|0.99||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cr at 2 weeks|
1741546|NCT00433381|3203865|Other|ROC analysis|Area Under the Curve (AUC)|0.54|||||2-Sided|95.0|0.14|0.95||||||AUC (Accuracy) estimate for the prediction of PFS-6 by change in metabolic ratio of tumor Cho/Cr at 2 weeks|
1741547|NCT00433381|3203865|Other|Receiver Operating Characteristic (ROC) analysis|Area Under the Curve (AUC)|0.5|||||2-Sided|95.0|0.09|0.91||||||Accuracy estimate, as measured by the Area under the Curve (AUC), for the prediction of PFS-6 by change in metabolic ratio of tumor NAA/Cho at 2 weeks|
1741548|NCT00433381|3203866|Other|||||||||||||||||Null hypothesis: 35% discontinuation rate of bevacizumab and temozolomide. Alternative hypothesis: 5%. Type I and II error rates = 0.10. Sample size = 29.|The determination of treatment tolerability was to be made based on the following rules: If 6 or fewer of the cases (6/29=20.6%) stop treatment due to medical conditions, then reject the null hypothesis that the discontinuation rate is at least 35% and conclude tolerability. If 7 or more of the cases (7/29=24.1%) stop treatment due to medical conditions, then reject the alternative hypothesis that the discontinuation rate no more than 15%.
1741549|NCT00433381|3203867|Other|||||||||||||||||Null hypothesis: 20% of patients progression-free at six months. Alternative hypothesis: 35%. Type I and II error rates = 0.10. Required sample size = 57.|The determination of treatment efficacy was to be made made based on the following rules: If 16 or more of the cases (16/57=28.1%) are progression free and alive at 6 months, then reject the null hypothesis that the rate is no better than 20%. If 15 or fewer of the cases (15/57=26.3%) are progression free and alive at 6 months, then reject the alternative hypothesis that the rate is at least 35%.
1741550|NCT00433290|3203871|Superiority or Other|||||||0.04|||||||t-test, 2 sided||||
1741551|NCT00433290|3203872|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA||||
1741552|NCT00433290|3203873|Superiority or Other|||||||0.668||||||P-value for DBP Change from Baseline. Change = Endpoint minus baseline.|ANOVA||||
1741553|NCT00433290|3203873|Superiority or Other|||||||0.285||||||P-value for SBP Change from Baseline. Change = Endpoint minus baseline.|ANOVA||||
1741554|NCT00433290|3203874|Superiority or Other|||||||0.005||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA||||
1741555|NCT00433290|3203875|Superiority or Other|||||||0.042||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANOVA||||
1741556|NCT00433290|3203876|Superiority or Other|||||||0.023||||||P-value for GGT Change from Baseline. Change = Endpoint minus baseline.|ANOVA||||
1741557|NCT00433290|3203876|Superiority or Other|||||||0.01||||||P-value for AST Change from Baseline. Change = Endpoint minus baseline.|ANOVA||||
1741558|NCT00433290|3203876|Superiority or Other||||||<|0.001||||||P-value for Alkaline Phosphatase Change from Baseline. Change = Endpoint minus baseline.|ANOVA||||
1741559|NCT00433290|3203878|Superiority or Other|||||||0.082||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA||||
1741560|NCT00433290|3203879|Superiority or Other|||||||0.131||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA||||
1741561|NCT00433290|3203880|Superiority or Other|||||||0.489||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA||||
1741562|NCT00433290|3203881|Superiority or Other|||||||0.26||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA||||
1741563|NCT00433290|3203882|Superiority or Other|||||||0.001||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA||||
1741564|NCT00433290|3203883|Superiority or Other|||||||0.066||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA||||
1741565|NCT00433290|3203884|Superiority or Other|||||||0.913||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA||||
1741568|NCT00433290|3203887|Superiority or Other|||||||0.002||||||P-value for direct analgesic effect. The null hypothesis was tested by testing a1=0 versus a1≠0.|Regression, Linear|||Path analysis was used to test null hypothesis that change in BPI average pain severity depends on improvement of BDI or HADS-A, versus improvement in BPI average pain severity is due to a direct analgesic effect of treatment and not dependent on improvement in depression or anxiety symptoms. Model:Change in BPI average pain score=a0+a1*treatment group+a2*change in BDI total+a3*change in HADS-A+a4*BL of BPI average pain+a5*BL of BDI total+a6*BL of HADS-A.|
1741569|NCT00433290|3203887|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA||||
1741570|NCT00433290|3203888|Superiority or Other|||||||0.015||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA||||
1741571|NCT00433290|3203889|Superiority or Other|||||||0.003||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA||||
1741572|NCT00433290|3203890|Superiority or Other|||||||0.138||||||P-value for Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.|||
1741573|NCT00433290|3203891|Superiority or Other|||||||0.871||||||P-value for Change from Baseline. Change = Week 13 value minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.|||
1741574|NCT00433290|3203892|Superiority or Other|||||||0.209||||||P-value for EQ-5D Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change=Treament, Pooled Investigator, NSAID use and Baseline for main effect p-value.|||
1741575|NCT00433290|3203893|Superiority or Other|||||||0.135||||||P-value for Vitality Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.|||
1741576|NCT00433290|3203893|Superiority or Other|||||||0.342||||||P-value for Social Functioning Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.|||
1741577|NCT00433290|3203893|Superiority or Other|||||||0.006||||||P-value for Role-Physical Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.|||
1741578|NCT00433290|3203893|Superiority or Other|||||||0.415||||||P-value for Role-Emotional Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.|||
1741579|NCT00433290|3203893|Superiority or Other|||||||0.019||||||P-value for Physical Functioning Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.|||
1741580|NCT00433290|3203893|Superiority or Other|||||||0.508||||||P-value for Mental Health Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.|||
1741581|NCT00433290|3203893|Superiority or Other|||||||0.051||||||P-value for General Health Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.|||
1741582|NCT00433290|3203893|Superiority or Other|||||||0.004||||||P-value for Bodily Pain Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.|||
1741583|NCT00433290|3203893|Superiority or Other||||||<|0.001||||||P-value for Physical Component Summary Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.|||
1741584|NCT00433290|3203893|Superiority or Other||||||<|0.897||||||P-value for Mental Component Summary Change from Baseline. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values.|||
1741585|NCT00433290|3203894|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1741586|NCT00433290|3203895|Superiority or Other|||||||0.009|||||||ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.|||
1741587|NCT00433290|3203896|Superiority or Other|||||||0.047||||||P-value for Change in Weekly 24-Hour Worst Pain. Change = Endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.|||
1741588|NCT00433290|3203896|Superiority or Other|||||||0.008||||||P-value for Change in Weekly 24-Hour Average Pain. Change = endpoint minus baseline.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.|||
1741589|NCT00433290|3203897|Superiority or Other|||||||0.064||||||P-value for Change from Baseline. Change = Week 13 value minus baseline value.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.|||
1741590|NCT00433290|3203898|Superiority or Other|||||||0.068||||||P-value for Change from Baseline. Change = Week 13 value minus baseline value.|ANCOVA|Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.|||
1741591|NCT00433290|3203899|Superiority or Other|||||||0.016||||||P-value for Change from Baseline (change = endpoint - baseline)|ANCOVA|Model: Change=Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value.|||
1741592|NCT00433290|3203900|Superiority or Other|||||||0.164|||||||ANCOVA|Model: PGI-Improvement=Treatment, Pooled Investigator, baseline severity and NSAID used for main effect p-values.|||
1741593|NCT00433290|3203901|Superiority or Other||||||<|0.001||||||P-value for Week 13 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment*Visit, Baseline*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.|
1741594|NCT00433290|3203901|Superiority or Other||||||<|0.001||||||P-value for Week 7 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment*Visit, Baseline*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.|
1741595|NCT00433290|3203901|Superiority or Other||||||<|0.001||||||P-value for Week 4 Change from Baseline. Treatment effects and interaction effects were evaluated based on two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|Mixed Models Analysis|Repeated Measures Model: Change=Treatment,NSAID use, Pooled Investigator, Visit, Baseline, Treatment*Visit, Baseline*Visit||Null hypothesis=the difference in the BPI average pain score between the duloxetine and placebo treatment goups at the last visit of the treatment phase is zero.|
1741596|NCT00433160|3203921|Superiority or Other||||||<|0.001||||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX from baseline to the last measurement point between the two treatment groups.|
1741597|NCT00433160|3203921|Superiority or Other||||||<|0.001||||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 52-week treatment between the two treatment groups.|
1741598|NCT00433160|3203921|Superiority or Other||||||<|0.001||||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 24-week treatment between the two treatment groups.|
1741599|NCT00433160|3203921|Superiority or Other||||||<|0.001||||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 12-week treatment between the two treatment groups.|
1741600|NCT00433160|3203921|Superiority or Other||||||<|0.976||||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in CTX after 4-week treatment between the two treatment groups.|
1741601|NCT00433160|3203922|Superiority or Other|||||||0.13||||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP from baseline to the last measurement point between the two treatment groups.|
1741602|NCT00433160|3203922|Superiority or Other|||||||0.06||||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wicoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 52-week treatment between the two treatment groups.|
1741603|NCT00433160|3203922|Superiority or Other||||||<|0.001||||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 24-week treatment between the two treatment groups.|
1741604|NCT00433160|3203922|Superiority or Other||||||<|0.001||||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 12-week treatment between the two treatment groups.|
1741605|NCT00433160|3203922|Superiority or Other||||||<|0.001||||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in BAP after 4-week treatment between the two treatment groups.|
1741606|NCT00433160|3203923|Superiority or Other||||||<|0.001||||||P-value for Percent Change to Last Measurement. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP from baseline to the last measurement point between the two treatment groups.|
1741607|NCT00433160|3203923|Superiority or Other||||||<|0.001||||||P-value for Percent Change to Week 52. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 52-week treatment between the two treatment groups.|
1741608|NCT00433160|3203923|Superiority or Other||||||<|0.001||||||P-value for Percent Change to Week 24. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 24-week treatment between the two treatment groups.|
1741609|NCT00433160|3203923|Superiority or Other||||||<|0.001||||||P-value for Percent Change to Week 12. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 12-week treatment between the two treatment groups.|
1741610|NCT00433160|3203923|Superiority or Other||||||<|0.001||||||P-value for Percent Change to Week 4. No adjustment for multiplicity was performed.|Wilcoxon's Rank Sum Test|||Null hypothesis: there is no difference in the percent change in PINP after 4-week treatment between the two treatment groups.|
1741611|NCT00433160|3203927|Superiority or Other||||||<|0.001||||||P-value for Percent Change to Last Measurement Point. No adjustments for multiplicity was performed.|t-test, 2 sided|||Null hypothesis: there is no difference in the percent change in bone mineral density at lumbar spine (L2-L4) after 52-week treatment between the two treatment groups.|
1741612|NCT00432965|3203941|Superiority||Odds Ratio (OR)|1.89||||0.007|2-Sided|95.0|1.19|3.02|||Fisher Exact|||Time Frame: Days 0-114|
1741613|NCT00432809|3203945|Superiority or Other|||||||0.03|||||||Chi-squared||||
1741614|NCT00432809|3203945|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1741615|NCT00432809|3203945|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1741616|NCT00432809|3203946|Superiority or Other|||||||0.62|||||||Chi-squared||||
1741617|NCT00432809|3203946|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1741618|NCT00432809|3203946|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1741619|NCT00432809|3203947|Superiority or Other|||||||0.06|||||||Chi-squared||||
1741620|NCT00432809|3203947|Superiority or Other|||||||0.46|||||||Chi-squared||||
1741621|NCT00432809|3203947|Superiority or Other|||||||0.48|||||||Chi-squared||||
1741622|NCT00432809|3203948|Superiority or Other|||||||0.2|||||||Chi-squared||||
1741623|NCT00432809|3203948|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1741624|NCT00432809|3203948|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1741625|NCT00432809|3203949|Superiority or Other|||||||0.2|||||||Chi-squared||||
1741626|NCT00432809|3203949|Superiority or Other|||||||0.06|||||||Chi-squared||||
1741627|NCT00432809|3203949|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1741676|NCT00432809|3203969|Superiority or Other|||||||0.59||||||Not adjusted for multiple comparisons|Chi-squared||||
1741677|NCT00432809|3203969|Superiority or Other|||||||0.008|||||||Chi-squared||||
1741678|NCT00432809|3203969|Superiority or Other|||||||0.002|||||||Chi-squared||||
1741679|NCT00432744|3203970|Superiority or Other|||||||0.42||||||The Hotelling T-sq=1.74 and 42% of the rerandomizations to groups of 7 and 8 had Hotelling T-sq of at least 1.74. This is the standard method for permutation tests. The large sample null is chi-sq with 2 df, which has a mean=2.|Non-parametric Hotelling T-square|||The actual study was powered to have 40 participants but only 24 participated and of these only 15 had outcome data.|
1741680|NCT00432744|3203971|Superiority or Other||Kendall's Tau B|0.3|Standard Error of the Mean|0.21||0.18|2-Sided|95.0|-0.12|0.72|||Wilcoxon (Mann-Whitney)||A positive value would favor CoQ.|Study intended to accrue 40 subjects, but only obtained 14 evaluable on this endpoint.|
1741681|NCT00432744|3203972|Superiority or Other||Kendall's Tau B|0.015|Standard Error of the Mean|0.23||0.95|2-Sided|95.0|-0.44|0.48||Two-sided Test|Wilcoxon (Mann-Whitney)||Positive value of Tau-B would favor CoQ.|Study intended to accrue 40 subjects, but only obtained 14 evaluable on this endpoint.|
1741682|NCT00432679|3203973|Superiority or Other||Mean Difference (Final Values)|20.5|||||2-Sided|95.0|5.6|35.3|||||Comparison of FPG, satisfied either 1 or 2||
1741683|NCT00432679|3203973|Superiority or Other||Mean Difference (Final Values)|6.9|||||2-Sided|95.0|-5.1|18.9|||||Comparison of FPG, fell below 126 milligrams per deciliter||
1741684|NCT00432679|3203973|Superiority or Other||Mean Difference (Final Values)|23.1|||||2-Sided|95.0|9.5|36.6|||||Comparison of FPG, decrease of 30 milligrams per decilliter||
1741685|NCT00432679|3203973|Superiority or Other||Mean Difference (Final Values)|40.6|||||2-Sided|95.0|27.1|54.1|||||Comparison of HbA1c, satisfied either 1 or 2||
1741686|NCT00432679|3203973|Superiority or Other||Mean Difference (Final Values)|6.8|||||2-Sided|95.0|-0.3|13.8|||||Comparison of HbA1c, fell below 6.5%||
1741687|NCT00432679|3203973|Superiority or Other||Mean Difference (Final Values)|40.6|||||2-Sided|95.0|27.1|54.1|||||Comparison of HbA1c, decrease by 0.7%||
1741688|NCT00432679|3203974|Superiority or Other||Mean Difference (Net)|-888.8|Standard Error of the Mean|803.96||0.271|2-Sided|95.0|-2477.7|700.1|||Unpaired t-test||Comparison of hs-CRP||
1741689|NCT00432679|3203974|Superiority or Other||Mean Difference (Net)|0.65|Standard Error of the Mean|0.355||0.069|2-Sided|95.0|-0.05|1.35|||Unpaired t-test||Comparison of leptin.||
1741690|NCT00432679|3203975|Superiority or Other||Mean Difference (Net)|8.21|Standard Error of the Mean|0.86|<|0.001|2-Sided|95.0|6.52|9.91|||Unpaired t-test||||
1741691|NCT00432679|3203976|Superiority or Other||Mean Difference (Net)|8.22|Standard Error of the Mean|3.556||0.022|2-Sided|95.0|1.191|15.248|||Unpaired t-test||||
1741692|NCT00432679|3203977|Superiority or Other||Mean Difference (Net)|-0.01|Standard Error of the Mean|0.473||0.983|2-Sided|95.0|-0.945|0.925|||Unpaired t-test||||
1741693|NCT00432679|3203978|Superiority or Other||Mean Difference (Net)|-2.04|Standard Error of the Mean|2.094||0.33|2-Sided|95.0|-6.18|2.09|||Unpaired t-test||||
1741694|NCT00432679|3203979|Superiority or Other||Mean Difference (Net)|0.718|Standard Error of the Mean|0.8102||0.377|2-Sided|95.0|-0.883|2.319|||Unpaired t-test||||
1741695|NCT00432679|3203980|Superiority or Other||Mean Difference (Net)|-22.1|Standard Error of the Mean|5.06|<|0.001|2-Sided|95.0|-32.1|-12.1|||Unpaired t-test||||
1741696|NCT00432679|3203981|Superiority or Other||Mean Difference (Net)|-0.81|Standard Error of the Mean|0.102|<|0.001|2-Sided|95.0|-1.01|-0.61||Change from Baseline in HbA1c = Treatment+ Baseline HbA1c+ Gender+ body mass index (BMI)|ANCOVA||||
1741697|NCT00432666|3204060|Superiority or Other||Odds Ratio (OR)|3.97|Standard Error of the Mean|1.49|<|0.001|2-Sided|95.0|1.9|8.3|||Regression, Logistic|||The null hypothesis was equality of the chance (OR = 1) for a clinically relevant treatment effect between incobotulinumtoxinA (Xeomin) and placebo at Week 4 for wrist flexors. Responders were defined as subjects with an improvement of at least 1 point in the Ashworth score compared with Baseline. The dependent variable was the response to treatment, the independent variables were treatment, Ashworth score at the Baseline Visit, pre-treated patient status, gender, age, BMI, and pooled sites.|
1741698|NCT00432458|3204076|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1741699|NCT00432458|3204077|Superiority or Other|||||||0.0048|||||||Chi-squared||||
1741700|NCT00432458|3204078|Superiority or Other|||||||0.02|||||||Log Rank|Model was stratified by beta-2 microglobulin (high vs low), lytic bone lesions (present vs not) and bone marrow labeling index (high vs low)|||
1741701|NCT00432276|3204107|Superiority or Other||LS Mean Difference|-6.1||||0.197|2-Sided|95.0|-15.4|3.2||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|||Comparison of change from Baseline at Week 52.|
1741702|NCT00432276|3204108|Superiority or Other||LS Mean Difference|-2.92|||<|0.001|2-Sided|95.0|-4.57|-1.27||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline adiponectin as covariates.||Comparison of change from Baseline at Week 52.|
1741703|NCT00432276|3204109|Superiority or Other||LS Mean Difference|-0.8209||||0.283|2-Sided|95.0|-2.3209|0.679||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline hsCRP as covariates.||Comparison of change from Baseline at Week 52.|
1741704|NCT00432276|3204110|Superiority or Other||LS Mean Difference|1.78||||0.308|2-Sided|95.0|-1.65|5.22||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline PAI-1 as covariates.||Comparison of change from Baseline at Week 52.|
1741705|NCT00432276|3204111|Superiority or Other||LS Mean Difference|-0.5||||0.022|2-Sided|95.0|-1.0|-0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein C-III as covariates.||Comparison of change from Baseline at Week 52.|
1742172|NCT00430248|3204446|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1741706|NCT00432276|3204112|Superiority or Other||LS Mean Difference|-2.9||||0.064|2-Sided|95.0|-5.9|0.2||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein B as covariates.||Comparison of change from Baseline at Week 52.|
1741707|NCT00432276|3204113|Superiority or Other||LS Mean Difference|-0.6||||0.07|2-Sided|95.0|-1.3|0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A2 as covariates.||Comparison of change from Baseline at Week 52.|
1741708|NCT00432276|3204114|Superiority or Other||LS Mean Difference|-0.1||||0.934|2-Sided|95.0|-2.9|2.6||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline apolipoprotein A1 as covariates.||Comparison of change from Baseline at Week 52.|
1741709|NCT00432276|3204115|Superiority or Other||LS Mean Difference|-0.0314||||0.059|2-Sided|95.0|-0.064|0.0012||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline free fatty acid as covariates.||Comparison of change from Baseline at Week 52.|
1741710|NCT00432276|3204116|Superiority or Other||LS Mean Difference|-8.6||||0.08|2-Sided|95.0|-18.3|1.0||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline triglycerides as covariates.||Comparison of change from Baseline at Week 52.|
1741711|NCT00432276|3204117|Superiority or Other||LS Mean Difference|-2.8||||0.132|2-Sided|95.0|-6.5|0.9||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline LDL cholesterol as covariates.||Comparison of change from Baseline at Week 52.|
1741712|NCT00432276|3204118|Superiority or Other||LS Mean Difference|-0.6||||0.228|2-Sided|95.0|-1.7|0.4||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HDL cholesterol as covariates.||Comparison of change from Baseline at Week 52.|
1741713|NCT00432276|3204119|Superiority or Other||LS Mean Difference|-4.2||||0.058|2-Sided|95.0|-8.6|0.1||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline total cholesterol as covariates.||Comparison of change from Baseline at Week 52.|
1741714|NCT00432276|3204120|Superiority or Other||LS Mean Difference|-0.5||||0.071|2-Sided|95.0|-1.03|0.04||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline body weight as covariates.||Comparison of change from Baseline at Week 52.|
1741715|NCT00432276|3204121|Superiority or Other||LS Mean Difference|12.963|||<|0.001|2-Sided|95.0|5.333|20.592||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA beta cell function as covariates.||Comparison of change from Baseline at Week 52.|
1741716|NCT00432276|3204122|Superiority or Other||LS Mean Difference|-0.188||||0.567|2-Sided|95.0|-0.83|0.455||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline HOMA insulin resistance as covariates.||Comparison of change from Baseline at Week 52.|
1741717|NCT00432276|3204123|Superiority or Other||LS Mean Difference|0.073||||0.23|2-Sided|95.0|-0.047|0.193||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline fasting C-peptide as covariates.||Comparison of change from Baseline at Week 52.|
1741718|NCT00432276|3204124|Superiority or Other||LS Mean Difference|-0.041|||<|0.001|2-Sided|95.0|-0.063|-0.018||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|Treatment, study schedule and geographic region as class variables, and baseline metformin dose and baseline proinsulin/insulin ratio as covariates.||Comparison of change from Baseline at Week 52.|
1741719|NCT00432276|3204125|Superiority or Other||LS Mean Difference|0.73||||0.276|2-Sided|95.0|-0.58|2.04||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and fasting insulin as covariates.||Comparison of change from Baseline at Week 52.|
1741720|NCT00432276|3204126|Superiority or Other||LS Mean Difference|-1.6||||0.116|2-Sided|95.0|-3.7|0.4||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and proinsulin as covariates.||Comparison of change from Baseline at Week 52.|
1741721|NCT00432276|3204127|Superiority or Other||||||<|0.001||||||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|Extended Mantel Haenszel Test|Treatment comparison was performed using nonparametric, covariance-adjusted, extended Mantel-Haenszel test.||Comparison of incidence of hyperglycemic rescue through Week 52.|
1741722|NCT00432276|3204128|Superiority or Other||||||<|0.001||||||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|Extended Mantel Haenszel Test|Treatment comparison was performed using nonparametric, covariance-adjusted, extended Mantel-Haenszel test.||Comparison of incidence of marked hyperglycemia through Week 52.|
1741723|NCT00432276|3204129|Superiority or Other||LS Mean Difference|-10.9|||<|0.001|2-Sided|95.0|-16.2|-5.7||Statistical test and resulting P-value are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule and geographic region as class variables, and baseline metformin dose and FPG as covariates.||Comparison of change from Baseline at Week 52.|
1742742|NCT00424294|3205332|Superiority or Other|||||||0.549|||||||Chi-squared|||Week 2: p-value was calculated by Chi-square test.|
1741724|NCT00432276|3204137|Superiority or Other||LS Mean Difference|-0.44|||<|0.001|2-Sided|95.0|-0.57|-0.31||Statistical tests and resulting P-values are 2-sided and was evaluated at the 0.05 significance level.|ANCOVA|ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.||Comparison of change from Baseline in HbA1c at Week 42.|
1741725|NCT00432276|3204138|Non-Inferiority or Equivalence|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.|LS mean difference|-0.42|||||1-Sided|97.5||-0.28|||||Least squares means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|Comparison of Change from Baseline at Week 52. The null hypothesis was that the average change from Baseline in HbA1c at Week 52 for the alogliptin 25 mg addition group is inferior to the average change for the pioglitazone titration group. The alternative hypothesis was that the change from Baseline in HbA1c for the alogliptin 25 mg addition group was non-inferior to the change for the pioglitazone titration group for at Week 52.|
1741726|NCT00432276|3204138|Non-Inferiority or Equivalence|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.|LS mean difference|-0.47|||||1-Sided|97.5||-0.35|||||Least squares means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and baseline metformin dose and baseline HbA1c as covariates.|The analysis was conducted at the 1-sided 0.025 significance level. Non-inferiority was demonstrated if the upper confidence limit for the LS mean difference was less than +0.3%.|
1741727|NCT00432237|3204139|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741728|NCT00432237|3204139|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741729|NCT00432237|3204140|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741730|NCT00432237|3204140|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741731|NCT00432237|3204141|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741732|NCT00432237|3204141|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741733|NCT00432237|3204142|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741734|NCT00432237|3204142|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741735|NCT00432237|3204143|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741736|NCT00432237|3204143|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741737|NCT00432237|3204144|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741738|NCT00432237|3204144|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741739|NCT00432237|3204145|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741740|NCT00432237|3204145|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741741|NCT00432237|3204146|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741742|NCT00432237|3204146|Superiority or Other||||||<|0.001|||||||Regression, Logistic|P-value constructed using a logistic model adjusting for baseline severity (moderate, severe), region (US, ex-US), treatment and age (continuous).|||
1741743|NCT00432042|3204171|Non-Inferiority or Equivalence|Anti-PRN difference|GMT ratio|1.18|||||2-Sided|95.0|1.03|1.36|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is > -5%.||
1741744|NCT00432042|3204171|Non-Inferiority or Equivalence|Anti-FHA difference|GMT ratio|1.09|||||2-Sided|95.0|0.98|1.23|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is > -5%.||
1741745|NCT00432042|3204171|Non-Inferiority or Equivalence|Anti-PT difference|GMT ratio|0.97|||||2-Sided|95.0|0.88|1.08|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is > -5%.||
1741746|NCT00432042|3204172|Non-Inferiority or Equivalence|Haemophilus Influenza type B difference|Mean Difference (Final Values)|2.97|||||2-Sided|95.0|-0.17|6.89|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is > -5%.||
1741747|NCT00432042|3204172|Non-Inferiority or Equivalence|Hepatitis B difference|Mean Difference (Final Values)|1.36|||||2-Sided|95.0|-0.29|4.24|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is > -5%.||
1741854|NCT00430950|3204247|Superiority or Other||Mean Difference (Net)|-1.6||||0.0031||95.0|-2.61|-0.53|||ANCOVA||daytime Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)||
1741748|NCT00432042|3204173|Non-Inferiority or Equivalence|Varicella difference|Mean Difference (Final Values)|2.53|||||2-Sided|95.0|-0.41|6.58|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is > -10%.||
1741749|NCT00432042|3204173|Non-Inferiority or Equivalence|Rubella difference|Mean Difference (Final Values)|-1.2|||||2-Sided|95.0|-3.19|1.35|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is > -10%.||
1741750|NCT00432042|3204173|Non-Inferiority or Equivalence|Mumps difference|Mean Difference (Final Values)|-1.83|||||2-Sided|95.0|-4.21|1.1|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is > -10%.||
1741751|NCT00432042|3204173|Non-Inferiority or Equivalence|Measles difference|Mean Difference (Final Values)|1.14|||||2-Sided|95.0|-1.62|4.82|||||Non-inferiority was declared when the lower bound of the two-sided 95% CI of the difference is > -10%.||
1741752|NCT00431847|3204188|Superiority or Other||Mean Difference (Net)|21.1166|Standard Error of the Mean|9.2462||0.0233|2-Sided|95.0|2.8992|39.3341|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741753|NCT00431847|3204188|Superiority or Other||Mean Difference (Net)|-0.5029|Standard Error of the Mean|5.9044||0.9322|2-Sided|95.0|-12.1376|11.1317|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741754|NCT00431847|3204188|Superiority or Other||Mean Difference (Net)|3.3635|Standard Error of the Mean|3.8899||0.3882|2-Sided|95.0|-4.3026|11.0296|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741755|NCT00431847|3204188|Superiority or Other||Chi-Squared|0.78||||0.8548|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741756|NCT00431847|3204188|Superiority or Other||Slope|-0.9776|Standard Error of the Mean|0.1426|<|0.0001|2-Sided|95.0|-1.2584|-0.6967|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury. T|
1741757|NCT00431847|3204189|Superiority or Other||Mean Difference (Net)|9.0118|Standard Error of the Mean|6.2663||0.1516|2-Sided|95.0|-3.327|21.3505|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741758|NCT00431847|3204189|Superiority or Other||Mean Difference (Net)|4.2896|Standard Error of the Mean|4.0186||0.2868|2-Sided|95.0|-3.625|12.2043|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741759|NCT00431847|3204189|Superiority or Other||Mean Difference (Net)|-0.9001|Standard Error of the Mean|2.6015||0.7297|2-Sided|95.0|-6.0247|4.2246|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741760|NCT00431847|3204189|Superiority or Other||Chi-Squared|2.72||||0.4361|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741761|NCT00431847|3204189|Superiority or Other||Slope|-0.2979|Standard Error of the Mean|0.07538||0.001|2-Sided|95.0|-0.4465|-0.1493|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741762|NCT00431847|3204190|Superiority or Other||Mean Difference (Net)|-9.7558|Standard Error of the Mean|6.092||0.1105|2-Sided|95.0|-21.7515|2.2399|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741855|NCT00430950|3204247|Superiority or Other||Mean Difference (Net)|-1.6||||0.0016||95.0|-2.58|-0.6|||ANCOVA||24 hour Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)||
1743958|NCT00408876|3207585|Superiority or Other|||||||0.039|||||||t-test, 2 sided||||
1741763|NCT00431847|3204190|Superiority or Other||Mean Difference (Net)|-3.7679|Standard Error of the Mean|3.7464||0.3155|2-Sided|95.0|-11.1478|3.612|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741764|NCT00431847|3204190|Superiority or Other||Mean Difference (Net)|1.5241|Standard Error of the Mean|2.4216||0.5297|2-Sided|95.0|-3.2469|6.2951|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741765|NCT00431847|3204190|Superiority or Other||Chi-Squared|1.45||||0.6942|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741766|NCT00431847|3204190|Superiority or Other||Slope|0.1629|Standard Error of the Mean|0.08284||0.0504|2-Sided|95.0|-0.00029|0.3261|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741767|NCT00431847|3204191|Superiority or Other||Mean Difference (Net)|8.5232|Standard Error of the Mean|7.2532||0.2411|2-Sided|95.0|-5.7608|22.8073|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741768|NCT00431847|3204191|Superiority or Other||Mean Difference (Net)|1.258|Standard Error of the Mean|4.4523||0.7778|2-Sided|95.0|-7.5129|10.0289|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741769|NCT00431847|3204191|Superiority or Other||Mean Difference (Net)|-0.9502|Standard Error of the Mean|2.8797||0.7417|2-Sided|95.0|-6.624|4.7236|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741770|NCT00431847|3204191|Superiority or Other||Chi-Squared|2.6||||0.4577|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741771|NCT00431847|3204191|Superiority or Other||Slope|-0.2349|Standard Error of the Mean|0.1003||0.0199|2-Sided|95.0|-0.4323|-0.03745|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741772|NCT00431847|3204192|Superiority or Other||Mean Difference (Net)|-12.9796|Standard Error of the Mean|6.5287||0.048|2-Sided|95.0|-25.8429|-0.1162|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741773|NCT00431847|3204192|Superiority or Other||Mean Difference (Net)|-5.2518|Standard Error of the Mean|4.0583||0.1969|2-Sided|95.0|-13.2466|2.743|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741774|NCT00431847|3204192|Superiority or Other||Mean Difference (Net)|2.4902|Standard Error of the Mean|2.6357||0.3458|2-Sided|95.0|-2.7036|7.684|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741775|NCT00431847|3204192|Superiority or Other||Chi-Squared|1.53||||0.6764|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741776|NCT00431847|3204192|Superiority or Other||Slope|-0.04113|Standard Error of the Mean|-0.04113||0.6602|2-Sided|95.0|-0.2252|0.1429|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741777|NCT00431847|3204193|Superiority or Other||Mean Difference (Net)|-10.3871|Standard Error of the Mean|6.1087||0.0903|2-Sided|95.0|-22.4174|1.6433|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741778|NCT00431847|3204193|Superiority or Other||Mean Difference (Net)|-2.4636|Standard Error of the Mean|3.7381||0.5105|2-Sided|95.0|-9.8289|4.9018|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741779|NCT00431847|3204193|Superiority or Other||Mean Difference (Net)|2.9879|Standard Error of the Mean|2.4264||0.2195|2-Sided|95.0|-1.7938|7.7697|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741780|NCT00431847|3204193|Superiority or Other||Chi-Squared|6.33||||0.0966|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741781|NCT00431847|3204193|Superiority or Other||Slope|-0.2888|Standard Error of the Mean|0.09078||0.0016|2-Sided|95.0|-0.4675|-0.11|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741782|NCT00431847|3204194|Superiority or Other||Mean Difference (Net)|11.825|Standard Error of the Mean|6.9715||0.0911|2-Sided|95.0|-1.904|25.5541|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741783|NCT00431847|3204194|Superiority or Other||Mean Difference (Net)|4.3376|Standard Error of the Mean|4.314||0.3157|2-Sided|95.0|-4.1592|12.8344|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741784|NCT00431847|3204194|Superiority or Other||Mean Difference (Net)|2.302|Standard Error of the Mean|2.8198||0.4151|2-Sided|95.0|-3.253|7.857|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741785|NCT00431847|3204194|Superiority or Other||Chi-Squared|4.89||||0.18|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741786|NCT00431847|3204194|Superiority or Other||Slope|-0.523|Standard Error of the Mean|0.08855|<|0.0001|2-Sided|95.0|-0.6973|-0.3486|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741787|NCT00431847|3204195|Superiority or Other||Mean Difference (Net)|-0.4499|Standard Error of the Mean|2.8061||0.8727|2-Sided|95.0|-5.9692|5.0694|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741788|NCT00431847|3204195|Superiority or Other||Mean Difference (Net)|3.4575|Standard Error of the Mean|2.0263||0.0889|2-Sided|95.0|-0.528|7.4431|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741789|NCT00431847|3204195|Superiority or Other||Mean Difference (Net)|0.6174|Standard Error of the Mean|1.3991||0.6593|2-Sided|95.0|-2.1348|3.3696|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741856|NCT00430950|3204248|Superiority or Other||Mean Difference (Net)|-0.3||||0.7328||95.0|-1.71|1.21|||ANCOVA||refers to 4 week change; from week 8 to week 12||
1741790|NCT00431847|3204195|Superiority or Other||Chi-Squared|2.43||||0.4884|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741791|NCT00431847|3204195|Superiority or Other||Slope|0.04639|Standard Error of the Mean|0.03562||0.1938|2-Sided|95.0|-0.02369|0.1165|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741792|NCT00431847|3204196|Superiority or Other||Mean Difference (Net)|-2.3457|Standard Error of the Mean|3.2285||0.4682|2-Sided|95.0|-8.7034|4.012|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741793|NCT00431847|3204196|Superiority or Other||Mean Difference (Net)|-0.2466|Standard Error of the Mean|2.0697||0.9053|2-Sided|95.0|-4.3231|3.8299|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741794|NCT00431847|3204196|Superiority or Other||Mean Difference (Net)|0.7246|Standard Error of the Mean|1.3351||0.5878|2-Sided|95.0|-1.9056|3.3547|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741795|NCT00431847|3204196|Superiority or Other||Chi-Squared|6.37||||0.095|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741796|NCT00431847|3204196|Superiority or Other||Slope|-0.2169|Standard Error of the Mean|0.04148|<|0.0001|2-Sided|95.0|-0.2987|-0.1352|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741797|NCT00431847|3204197|Superiority or Other||Mean Difference (Net)|-8.37|Standard Error of the Mean|3.0921||0.007|2-Sided|95.0|-14.4589|-2.281|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741798|NCT00431847|3204197|Superiority or Other||Mean Difference (Net)|-3.3505|Standard Error of the Mean|1.977||0.0914|2-Sided|95.0|-7.2442|0.5432|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741799|NCT00431847|3204197|Superiority or Other||Mean Difference (Net)|-0.9534|Standard Error of the Mean|1.2763||0.4558|2-Sided|95.0|-3.4675|1.5607|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741800|NCT00431847|3204197|Superiority or Other||Chi-Squared|1.83||||0.6075|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741801|NCT00431847|3204197|Superiority or Other||Slope|0.4741|Standard Error of the Mean|0.03909|<|0.0001|2-Sided|95.0|0.3971|0.5511|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741802|NCT00431847|3204198|Superiority or Other||Mean Difference (Net)|-7.1649|Standard Error of the Mean|5.3759||0.1837|2-Sided|95.0|-17.7484|3.4187|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741857|NCT00430950|3204248|Superiority or Other||Mean Difference (Net)|-0.3||||0.7019||95.0|-1.84|1.24|||ANCOVA||refers to 8 week change; from week 8 to week 16||
1741858|NCT00430950|3204249|Superiority or Other||Mean Difference (Net)|-0.4||||0.4246||95.0|-1.26|0.53|||ANCOVA||||
1741803|NCT00431847|3204198|Superiority or Other||Mean Difference (Net)|1.2227|Standard Error of the Mean|3.9633||0.758|2-Sided|95.0|-6.5833|9.0286|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741804|NCT00431847|3204198|Superiority or Other||Mean Difference (Net)|3.1574|Standard Error of the Mean|2.7573||0.2532|2-Sided|95.0|-2.2715|8.5863|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741805|NCT00431847|3204198|Superiority or Other||Chi-Squared|3.2||||0.3617|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741806|NCT00431847|3204198|Superiority or Other||Slope|-0.4831|Standard Error of the Mean|0.1243||0.0002|2-Sided|95.0|-0.7286|-0.2377|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741807|NCT00431847|3204199|Superiority or Other||Mean Difference (Net)|0.6873|Standard Error of the Mean|0.4482||0.1261|2-Sided|95.0|-0.1943|1.5689|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741808|NCT00431847|3204199|Superiority or Other||Mean Difference (Net)|0.1708|Standard Error of the Mean|0.3212||0.5953|2-Sided|95.0|-0.461|0.8026|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741809|NCT00431847|3204199|Superiority or Other||Mean Difference (Net)|-0.05816|Standard Error of the Mean|0.221||0.7926|2-Sided|95.0|-0.4929|0.3766|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741810|NCT00431847|3204199|Superiority or Other||Chi-Squared|3.16||||0.3677|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741811|NCT00431847|3204199|Superiority or Other||Slope|-0.03645|Standard Error of the Mean|0.005913|<|0.0001|2-Sided|95.0|-0.04808|-0.02481|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741812|NCT00431847|3204200|Superiority or Other||Mean Difference (Net)|0.6759|Standard Error of the Mean|0.391||0.0847|2-Sided|95.0|-0.09297|1.4448|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741813|NCT00431847|3204200|Superiority or Other||Mean Difference (Net)|0.0428|Standard Error of the Mean|0.28||0.8786|2-Sided|95.0|-0.5079|0.5935|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741814|NCT00431847|3204200|Superiority or Other||Mean Difference (Net)|-0.3079|Standard Error of the Mean|0.1918||0.1094|2-Sided|95.0|-0.6851|0.06941|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741815|NCT00431847|3204200|Superiority or Other||Chi-Squared|3.88||||0.2752|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741859|NCT00430950|3204250|Superiority or Other||Mean Difference (Net)|-0.5||||0.2648||95.0|-1.51|0.42|||ANCOVA|||"The ANCOVA model included treatment as main effect and baseline mean trough sitting dBP as covariate.~Significance level alpha = 5%. Power = 80%.~The following statistical superiority hypothesis was tested:~Superiority of OM/HCTZ combination therapy 40/25 mg over OM/HCTZ 20/25 mg"|
1741816|NCT00431847|3204200|Superiority or Other||Slope|-0.02776|Standard Error of the Mean|0.004706|<|0.0001|2-Sided|95.0|-0.03702|-0.0185|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741817|NCT00431847|3204201|Superiority or Other||Mean Difference (Net)|1.2969|Standard Error of the Mean|0.5609||0.0213|2-Sided|95.0|0.1938|2.4|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741818|NCT00431847|3204201|Superiority or Other||Mean Difference (Net)|0.3568|Standard Error of the Mean|0.4009||0.3741|2-Sided|95.0|-0.4318|1.1453|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741819|NCT00431847|3204201|Superiority or Other||Mean Difference (Net)|-0.1004|Standard Error of the Mean|0.2746||0.7148|2-Sided|95.0|-0.6404|0.4396|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741820|NCT00431847|3204201|Superiority or Other||Chi-Squared|3.19||||0.3631|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741821|NCT00431847|3204201|Superiority or Other||Slope|-0.0403|Standard Error of the Mean|0.007196|<|0.0001|2-Sided|95.0|-0.5446|-0.02613|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741822|NCT00431847|3204202|Superiority or Other||Mean Difference (Net)|0.4482|Standard Error of the Mean|0.3502||0.2014|2-Sided|95.0|-0.2405|1.1369|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741823|NCT00431847|3204202|Superiority or Other||Mean Difference (Net)|0.2919|Standard Error of the Mean|0.2506||0.2448|2-Sided|95.0|-0.2009|0.7848|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741824|NCT00431847|3204202|Superiority or Other||Mean Difference (Net)|0.0386|Standard Error of the Mean|0.1718||0.8223|2-Sided|95.0|-0.2993|0.3765|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741825|NCT00431847|3204202|Superiority or Other||Chi-Squared|3.4||||0.3345|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741826|NCT00431847|3204202|Superiority or Other||Slope|-0.02746|Standard Error of the Mean|0.004202|<|0.0001|2-Sided|95.0|-0.03573|-0.01919|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741827|NCT00431847|3204203|Superiority or Other||Mean Difference (Net)|0.3082|Standard Error of the Mean|0.3066||0.3155|2-Sided|95.0|-0.2948|0.9112|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741828|NCT00431847|3204203|Superiority or Other||Mean Difference (Net)|0.2004|Standard Error of the Mean|0.2194||0.3616|2-Sided|95.0|-0.2311|0.6319|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741860|NCT00430781|3204253|Superiority or Other||Hazard Ratio, log|0.66||||0.013||90.0|0.48|0.91||Stratified log-rank test with one-sided p-value.|Log Rank||||
1741861|NCT00430781|3204257|Superiority or Other|||||||0.237||||||One-sided p-value.|Fisher Exact||||
1741829|NCT00431847|3204203|Superiority or Other||Mean Difference (Net)|0.07724|Standard Error of the Mean|0.1503||0.6077|2-Sided|95.0|-0.2184|0.3729|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741830|NCT00431847|3204203|Superiority or Other||Chi-Squared|2.49||||0.4772|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741831|NCT00431847|3204203|Superiority or Other||Slope|-0.02332|Standard Error of the Mean|0.003777|<|0.0001|2-Sided|95.0|-0.03076|-0.01589|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741832|NCT00431847|3204204|Superiority or Other||Mean Difference (Net)|0.8591|Standard Error of the Mean|0.4716||0.0694|2-Sided|95.0|-0.06841|1.7866|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741833|NCT00431847|3204204|Superiority or Other||Mean Difference (Net)|0.3299|Standard Error of the Mean|0.3372||0.3286|2-Sided|95.0|-0.3334|0.9932|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741834|NCT00431847|3204204|Superiority or Other||Mean Difference (Net)|-0.108|Standard Error of the Mean|0.2308||0.64|2-Sided|95.0|-0.5621|0.3461|||Mixed Models Analysis|RA groups treated as classification variables with No RA group as reference.|Estimated intercept group difference|A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.|
1741835|NCT00431847|3204204|Superiority or Other||Chi Squared|2.65||||0.4492|2-Sided||||||Chi-squared|Degrees of Freedom: 3||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.|
1741836|NCT00431847|3204204|Superiority or Other||Slope|-0.0323|Standard Error of the Mean|0.00619|<|0.0001|2-Sided|95.0|-0.0448|-0.02013|||Mixed Models Analysis|||A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.|
1741837|NCT00431834|3204205|Superiority or Other||binomial proportions|5.3|||<|0.0001|1-Sided|97.5||13.1||The percent of subjects following treatment, p, who experience any of the MAEs during the first 30 days following surgery, or hospital discharge, whichever is longer will be less than 23.6%.|Fisher Exact|||"The specific test hypothesis is as follows:~H0: p ≥ 23.6% Ha: p < 23.6%"|
1741838|NCT00431834|3204208|Superiority or Other||binomial proportions|37.7|||<|0.0041|1-Sided|97.5|25.6|||The percent of patients off Class I and III AADs and successfully converted out of AF following treatment (ptest) will exceed the percenter of patients off Class I and III AADs and convereted out of AF, as reported in literature (pcontrol=22.1%)|Fisher Exact|||"The specific test hypothesis is as follows:~H0: ptest ≤ 22.1% Ha: ptest > 22.1%"|
1741839|NCT00431496|3204210|Superiority or Other||Percentage of participants|46.5||||||95.0|34.9|58.1|||||||
1741840|NCT00431496|3204211|Superiority or Other||Percentage of participants|53.5||||||95.0|41.9|65.1|||||||
1741841|NCT00431496|3204212|Superiority or Other||Percentage of participants|54.9||||||95.0|43.4|66.5|||||||
1741842|NCT00431496|3204213|Superiority or Other||Percentage of participants|78.9||||||95.0|69.4|88.4|||||||
1741843|NCT00431496|3204214|Superiority or Other||Percentage of participants|52.1||||||95.0|40.5|63.7|||||||
1741844|NCT00431496|3204215|Superiority or Other||Percentage of participants|42.3||||||95.0|30.8|53.7|||||||
1741845|NCT00431184|3204226|Superiority or Other|||||||0.83|||||||Mixed Models Analysis||||
1741846|NCT00431184|3204227|Superiority or Other|||||||0.22|||||||Mixed Models Analysis||||
1741847|NCT00431041|3204237|Superiority or Other|||||||0.001||||||P-value represents overall comparison of severity of dry mouth.|Chi-squared||||
1741848|NCT00431041|3204238|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1741849|NCT00430950|3204246|Superiority or Other||Odds Ratio (OR)|1.09||||||95.0|0.85|1.4|||||||
1741850|NCT00430950|3204247|Superiority or Other||Mean Difference (Net)|-2.0||||0.0104||95.0|-3.61|-0.48|||ANCOVA||night-time Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)||
1741851|NCT00430950|3204247|Superiority or Other||Mean Difference (Net)|-2.3||||0.0031||95.0|-3.76|-0.76|||ANCOVA||daytime Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)||
1741852|NCT00430950|3204247|Superiority or Other||Mean Difference (Net)|-2.3||||0.0021||95.0|-3.71|-0.82|||ANCOVA||24 hour Ambulatory Blood Pressure Monitoring (ABPM) systolic blood pressure (sBP)||
1741853|NCT00430950|3204247|Superiority or Other||Mean Difference (Net)|-1.5||||0.0073||95.0|-2.58|-0.4|||ANCOVA||night-time Ambulatory Blood Pressure Monitoring (ABPM) diastolic blood pressure (dBP)||
1741862|NCT00430781|3204260|Superiority or Other||Hazard Ratio (HR)|1.05||||0.535||90.0|0.65|1.7||Stratified log-rank test with one-sided p-value. p<=0.0037 required for significance, and p>0.4956 indicated futility.|Log Rank||The estimated value is the hazard ratio comparing combination to lapatinib monotherapy||
1741863|NCT00430716|3204264|Superiority or Other||Mean Difference (Net)|0.0||||0.141|2-Sided|95.0|0.0|1.0|||Wilcoxon (Van-Elteren)|||A stratified Wilcoxon test (Van-Elteren) was used. The stratified median difference and corresponding two-sided 95% CI (calculated using the Hodges-Lehmann estimator) was presented along with the p-value for the test.|
1741864|NCT00430716|3204264|Superiority or Other||Median Difference (Net)|0.0||||0.382|2-Sided|95.0|-1.0|0.0|||Wilcoxon (Van-Elteren)|||A stratified Wilcoxon test (Van-Elteren) was used. The stratified median difference and corresponding two-sided 95% CI (calculated using the Hodges-Lehmann estimator) was presented along with the p-value for the test.|
1741865|NCT00430716|3204265|Superiority or Other||Mean Difference (Net)|-0.1||||0.2|2-Sided|95.0|-0.26|0.06|||ANCOVA|||ANCOVA method was used with baseline TAPSE measurement fitted as a covariate. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.|
1741866|NCT00430716|3204265|Superiority or Other||Mean Difference (Net)|-0.08||||0.31|2-Sided|95.0|-0.24|0.08|||ANCOVA|||ANCOVA method was used with baseline TAPSE measurement fitted as a covariate. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.|
1741867|NCT00430716|3204266|Superiority or Other||Median Difference (Net)|-141.45||||0.414|2-Sided|95.0|-483.48|200.58|||ANCOVA|||ANCOVA method was used with baseline pro-BNP level fitted as a covariate. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.|
1741868|NCT00430716|3204266|Superiority or Other||Mean Difference (Net)|-462.12||||0.009|2-Sided|95.0|-807.53|-116.71|||ANCOVA|||ANCOVA method was used with baseline pro-BNP level fitted as a covariate. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.|
1741869|NCT00430716|3204267|Superiority or Other||Mean Difference (Net)|-25.0||||0.496|2-Sided|95.0|-97.5|47.5|||ANCOVA|||ANCOVA method was used with baseline BNP level fitted as a covariate. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.|
1741870|NCT00430716|3204267|Superiority or Other||Mean Difference (Net)|-104.8||||0.005|2-Sided|95.0|-177.44|-32.16|||ANCOVA|||ANCOVA method was used with baseline BNP level fitted as a covariate. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.|
1741871|NCT00430716|3204268|Superiority or Other||Odds Ratio (OR)|1.08||||0.897|2-Sided|95.0|0.35|3.32|||Regression, Logistic|||The analysis of the week 12 PAH functional class was done with proportional odds logistic regression with baseline functional class as an additional covariate.The odds ratio and corresponding two-sided 95% CI for the odds ratio for the treatment comparisons was presented along with the p-value for the tests.|
1741872|NCT00430716|3204268|Superiority or Other||Odds Ratio (OR)|1.55||||0.448|2-Sided|95.0|0.5|4.78|||Regression, Logistic|||The analysis of the week 12 PAH functional class was done with proportional odds logistic regression with baseline functional class as an additional covariate.The odds ratio and corresponding two-sided 95% CI for the odds ratio for the treatment comparisons was presented along with the p-value for the tests.|
1741873|NCT00430716|3204270|Superiority or Other||Mean Difference (Net)|-0.44||||0.846|2-Sided|95.0|-4.98|4.09|||ANCOVA|||The analysis of change from baseline in week 12 mean PAP used ANCOVA, with baseline mean PAP fitted as covariate. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.|
1741874|NCT00430716|3204270|Superiority or Other||Mean Difference (Net)|-2.51||||0.278|2-Sided|95.0|-7.07|2.05|||ANCOVA|||The analysis of change from baseline in week 12 mean PAP used Analysis of Covariance (ANCOVA), with baseline mean PAP fitted as covariate. The mean difference and corresponding two-sided 95% CI for the comparisons of sildenafil 20 mg against the lower sildenafil dose (1 mg) was presented along with the p-value for the test.|
1741875|NCT00430716|3204271|Superiority or Other||Mean Difference (Net)|-1.17||||0.545|1-Sided|97.5|-21.48||||ANOVA|||ANOVA model followed by the Williams trend test (one-sided, at the 2.5% level of significance) was used. The Williams trend test firstly determined if there was a significant downward trend in response for the descending doses, and then subsequently determined the highest dose that was statistically inferior to 20 mg (known to be an effective dose of sildenafil). A corresponding 97.5% one-sided CI for the difference was presented.|
1741876|NCT00430716|3204271|Superiority or Other||Mean Difference (Net)|24.15||||0.011|1-Sided|97.5|3.37||||ANOVA|||An analysis of variance (ANOVA) model followed by the Williams trend test (one-sided, at the 2.5% level of significance) was used. The Williams trend test firstly determined if there was a significant downward trend in response for the descending doses, and then subsequently determined the highest dose that was statistically inferior to 20 mg (known to be an effective dose of sildenafil). A corresponding 97.5% one-sided confidence interval (CI) for the difference was presented.|
1741877|NCT00430677|3204302|Superiority or Other||Mean Difference (Final Values)|-0.02|||||2-Sided|95.0|-0.18|0.14|||||Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.||
1741878|NCT00430677|3204302|Superiority or Other||Mean Difference (Final Values)|0.03|||||2-Sided|95.0|-0.13|0.19|||||Adjustment based on ANCOVA model with treatment as factor and randomization strata (prior treatment status) and baseline measurements as covariates.||
1741879|NCT00430677|3204304|Superiority or Other||Odds Ratio (OR)|0.88|||||2-Sided|95.0|0.49|1.59|||||||
1741880|NCT00430677|3204304|Superiority or Other||Odds Ratio (OR)|1.21|||||2-Sided|95.0|0.68|21.3|||||||
1741881|NCT00430677|3204310|Superiority or Other||Cox Proportional Hazard|1.3|||||2-Sided|95.0|0.91|1.77|||||Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.||
1741882|NCT00430677|3204310|Superiority or Other||Cox Proportional Hazard|1.3|||||2-Sided|95.0|0.91|1.78|||||Point Estimate, 95% CI for the hazard ratio was determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.||
1741883|NCT00430677|3204313|Superiority or Other||Cox Proportional Hazard|1.6||||0.118|2-Sided|95.0|0.89|2.83||The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.|Regression, Cox||Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.||
1741884|NCT00430677|3204313|Superiority or Other||Cox Proportional Hazard|1.1||||0.746|2-Sided|95.0|0.6|2.03||The median time to confirmed CRR was not estimable due to the low number of events. However, the time to confirmed CRR was compared between the abatacept and placebo treatment regimens using a score test.|Regression, Cox||Point estimate, 95% CI and P-value (based on Score Test) for the hazard ratio is determined by a Cox proportional hazards model including treatment as a covariate and stratified by prior treatment status.||
1741885|NCT00430638|3204314|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons|
1741886|NCT00430638|3204314|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - Stage 2 hypertensive participants): For the Stage 2 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons|
1741887|NCT00430638|3204315|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons|
1741888|NCT00430638|3204315|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - Stage 1 hypertensive participants): For the Stage 1 efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons|
1741889|NCT00430638|3204316|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis(Diastolic blood pressure (DBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons|
1741890|NCT00430638|3204316|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - non-Black participants): For the Non-Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons|
1741891|NCT00430638|3204317|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons|
1741892|NCT00430638|3204317|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - Black participants): For the Black efficacy population, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons|
1741893|NCT00430638|3204318|Superiority or Other|||||||0.0006|||||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) > or equal to 65): For the efficacy population > or = to 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.|
1741894|NCT00430638|3204318|Superiority or Other|||||||0.0125|||||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - > or equal to 65 years old): For the efficacy population > or = to 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.|
1741895|NCT00430638|3204319|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - less than 65 years of age): For the efficacy population < 65 years of age, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.|
1741896|NCT00430638|3204319|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis(Systolic blood pressure (SBP) - less than 65 years of age): For the efficacy population < 65 years of age, Olmesartan had the same effect on change from baseline in SBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.|
1741897|NCT00430638|3204320|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis (Diastolic blood pressure (DBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in DBP at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.|
1741898|NCT00430638|3204320|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis (Systolic blood pressure (SBP) - females): For the female efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.|
1741899|NCT00430638|3204321|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis (Males - diastolic blood pressure (DBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.|
1742743|NCT00424294|3205332|Superiority or Other|||||||0.463|||||||Chi-squared|||Week 1: p-value was calculated by Chi-square test.|
1741900|NCT00430638|3204321|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null hypothesis (male systolic blood pressure (SBP)): For the male efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.|
1741901|NCT00430638|3204322|Superiority or Other||||||<|0.0001|||||||ANCOVA|The ANCOVA Model included randomized treatment and baseline cuff BP stage as factors and study baseline diastolic BP as a covariate.||Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in diastolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.|
1741902|NCT00430638|3204323|Superiority or Other||||||<|0.0001||||||No multiplicity adjustments|ANCOVA|The ANCOVA model included randomized treatment and baseline cuff blood pressure stage as factors and study baseline systolic BP value as a covariate.||Null hypothesis: For the entire efficacy population, Olmesartan had the same effect on change from baseline in systolic blood pressure at week 12 as Placebo. A statistical test was evaluated at the 2 sided significance level of 5% without adjustment for multiple comparisons.|
1741903|NCT00430625|3204330|Superiority or Other||Mean Difference (Final Values)|2.429|Standard Error of the Mean|0.324|<|0.0001|2-Sided|95.0|1.717|3.141|||paired t-test|||Primary endpoint was based solely on the 60 U/kg treatment arm|
1741904|NCT00430508|3204384|Superiority or Other||Mean Difference (Net)|-1.0||||0.1985||95.0|-2.55|0.53|||ANCOVA||||
1741905|NCT00430508|3204384|Superiority or Other||Mean Difference (Net)|-2.6|||<|0.0009||95.0|-4.12|-1.07|||ANCOVA||||
1741906|NCT00430508|3204384|Superiority or Other||Mean Difference (Net)|-5.5|||<|0.0001||95.0|-7.4|-3.62|||ANCOVA||||
1741907|NCT00430508|3204385|Superiority or Other||Mean Difference (Net)|-1.0||||0.1629||95.0|-2.52|0.42|||ANCOVA||||
1741908|NCT00430508|3204385|Superiority or Other||Mean Difference (Net)|-3.3|||<|0.0001||95.0|-4.79|-1.87|||ANCOVA||||
1741909|NCT00430508|3204385|Superiority or Other||Mean Difference (Net)|-5.0|||<|0.0001||95.0|-6.79|-3.17|||ANCOVA||||
1741910|NCT00430508|3204386|Superiority or Other||Mean Difference (Net)|-1.0||||0.1452||95.0|-2.43|0.36|||ANCOVA||||
1741911|NCT00430508|3204386|Superiority or Other||Mean Difference (Net)|-3.2|||<|0.0001||95.0|-4.54|-1.78|||ANCOVA||||
1741912|NCT00430508|3204386|Superiority or Other||Mean Difference (Net)|-5.1|||<|0.0001||95.0|-6.78|-3.36|||ANCOVA||||
1741913|NCT00430508|3204387|Superiority or Other||Odds Ratio (OR)|1.55||||||95.0|1.07|2.25|||||||
1741914|NCT00430508|3204387|Superiority or Other||Odds Ratio (OR)|2.2||||||95.0|1.5|3.24|||||||
1741915|NCT00430508|3204387|Superiority or Other||Odds Ratio (OR)|2.67||||||95.0|1.69|4.21|||||||
1741916|NCT00430508|3204388|Superiority or Other||Mean Difference (Net)|-1.7||||0.0812||95.0|-3.66|0.21|||ANCOVA||||
1741917|NCT00430508|3204388|Superiority or Other||Mean Difference (Net)|-4.8|||<|0.0001||95.0|-6.7|-2.81|||ANCOVA||||
1741918|NCT00430508|3204388|Superiority or Other||Mean Difference (Net)|-6.6|||<|0.0001||95.0|-9.0|-4.26|||ANCOVA||||
1741919|NCT00430508|3204389|Superiority or Other||Mean Difference (Net)|-2.6||||0.0255||95.0|-4.79|-0.31|||ANCOVA||||
1741920|NCT00430508|3204389|Superiority or Other||Mean Difference (Net)|-5.2|||<|0.0001||95.0|-7.4|-2.91|||ANCOVA||||
1741921|NCT00430508|3204389|Superiority or Other||Mean Difference (Net)|-7.4|||<|0.0001||95.0|-10.13|-4.66|||ANCOVA||||
1741922|NCT00430508|3204390|Superiority or Other||Mean Difference (Net)|-1.0||||0.1081||95.0|-2.19|0.22|||ANCOVA||||
1741923|NCT00430508|3204390|Superiority or Other||Mean Difference (Net)|-3.2|||<|0.0001||95.0|-4.39|-1.98|||ANCOVA||||
1741924|NCT00430508|3204390|Superiority or Other||Mean Difference (Net)|-4.1|||<|0.0001||95.0|-5.54|-2.6|||ANCOVA||||
1741925|NCT00430508|3204391|Superiority or Other||Mean Difference (Net)|-0.9||||0.1788||95.0|-2.32|0.43|||ANCOVA||||
1741926|NCT00430508|3204391|Superiority or Other||Mean Difference (Net)|-3.4|||<|0.0001||95.0|-4.79|-2.03|||ANCOVA||||
1741927|NCT00430508|3204391|Superiority or Other||Mean Difference (Net)|-5.3|||<|0.0001||95.0|-6.97|-3.6|||ANCOVA||||
1741928|NCT00430300|3204418|Superiority or Other||Odds Ratio (OR)|0.5877|||||2-Sided|95.0|0.1516|2.2777||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.|
1741929|NCT00430300|3204418|Superiority or Other||Odds Ratio (OR)|0.6416|||||2-Sided|95.0|0.1736|2.3715||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.|
1741930|NCT00430300|3204418|Superiority or Other||Odds Ratio (OR)|0.5709|||||2-Sided|95.0|0.179|1.8204||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.|
1741931|NCT00430300|3204419|Superiority or Other||Odds Ratio (OR)|0.327|||||2-Sided|95.0|0.083|1.2879||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.|
1741932|NCT00430300|3204419|Superiority or Other||Odds Ratio (OR)|0.5574|||||2-Sided|95.0|0.1505|2.0647||||||A proportional odds model was fitted using Proc Logistic in SAS, using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.|
1741933|NCT00430300|3204419|Superiority or Other||Odds Ratio (OR)|0.6428|||||2-Sided|95.0|0.2023|2.0419||||||A proportional odds model was fitted using Proc Logistic in Statistical Analysis System (SAS), using treatment as a categorical variable and center as a covariate. The odds ratio and corresponding 95% confidence interval were tested using Type III (Wald) tests.|
1742092|NCT00430300|3204431|Superiority or Other||Adjusted Mean Difference|-0.05|Standard Error of the Mean|0.05||0.8402|1-Sided|95.0|-0.14||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741934|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|0.9|Standard Error of the Mean|9.6||0.4629|1-Sided|95.0|-15.0||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741935|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-12.3|Standard Error of the Mean|10.8||0.8707|1-Sided|95.0|-30.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741936|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|2.8|Standard Error of the Mean|11.0||0.4001|1-Sided|95.0|-15.6||||Mixed Models Analysis|||Evening PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741937|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-6.4|Standard Error of the Mean|9.0||0.7591|1-Sided|95.0|-21.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741938|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-12.2|Standard Error of the Mean|10.2||0.8821|1-Sided|95.0|-29.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741939|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|0.9|Standard Error of the Mean|10.4||0.464|1-Sided|95.0|-16.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741940|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-3.9|Standard Error of the Mean|9.1||0.6667|1-Sided|95.0|-19.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741941|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-9.0|Standard Error of the Mean|10.3||0.8063|1-Sided|95.0|-26.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741942|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-1.9|Standard Error of the Mean|10.6||0.5705|1-Sided|95.0|-19.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741943|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-18.1|Standard Error of the Mean|8.7||0.9802|1-Sided|95.0|-32.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741944|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-22.4|Standard Error of the Mean|9.8||0.9876|1-Sided|95.0|-38.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741945|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-14.5|Standard Error of the Mean|10.0||0.9242|1-Sided|95.0|-31.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741946|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-1.3|Standard Error of the Mean|7.3||0.5701|1-Sided|95.0|-13.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741947|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-14.1|Standard Error of the Mean|8.3||0.9538|1-Sided|95.0|-27.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741948|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-2.8|Standard Error of the Mean|8.4||0.6286|1-Sided|95.0|-16.8||||Mixed Models Analysis|||Evening PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741949|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-4.8|Standard Error of the Mean|7.4||0.7387|1-Sided|95.0|-17.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741950|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-23.2|Standard Error of the Mean|8.4||0.9963|1-Sided|95.0|-37.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741951|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-7.1|Standard Error of the Mean|8.6||0.7929|1-Sided|95.0|-21.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741952|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-7.3|Standard Error of the Mean|8.5||0.8014|1-Sided|95.0|-21.4||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742166|NCT00430248|3204444|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1741953|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-15.9|Standard Error of the Mean|9.7||0.9473|1-Sided|95.0|-32.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741954|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-3.0|Standard Error of the Mean|9.8||0.619|1-Sided|95.0|-19.3||||Mixed Models Analysis|||Evening PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741955|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-1.1|Standard Error of the Mean|6.0||0.5743|1-Sided|95.0|-11.1||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741956|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-4.1|Standard Error of the Mean|6.8||0.7238|1-Sided|95.0|-15.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741957|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|1.0|Standard Error of the Mean|6.9||0.4436|1-Sided|95.0|-10.5||||Mixed Models Analysis|||Evening PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741958|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|3.9|Standard Error of the Mean|9.6||0.3441|1-Sided|95.0|-12.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741959|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-9.2|Standard Error of the Mean|10.9||0.8005|1-Sided|95.0|-27.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741960|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-12.1|Standard Error of the Mean|11.1||0.8598|1-Sided|95.0|-30.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741961|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|3.3|Standard Error of the Mean|8.9||0.3535|1-Sided|95.0|-11.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741962|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|1.1|Standard Error of the Mean|10.1||0.4566|1-Sided|95.0|-15.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741963|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-7.6|Standard Error of the Mean|10.3||0.7695|1-Sided|95.0|-24.8||||Mixed Models Analysis|||Morning PEFR, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741964|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|2.0|Standard Error of the Mean|9.4||0.417|1-Sided|95.0|-13.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741965|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-0.6|Standard Error of the Mean|10.7||0.5239|1-Sided|95.0|-18.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741966|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-7.0|Standard Error of the Mean|11.0||0.7384|1-Sided|95.0|-25.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741967|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-12.7|Standard Error of the Mean|8.3||0.9345|1-Sided|95.0|-26.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741968|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-8.9|Standard Error of the Mean|9.4||0.8249|1-Sided|95.0|-24.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741969|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-18.6|Standard Error of the Mean|9.7||0.9705|1-Sided|95.0|-34.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741970|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|2.0|Standard Error of the Mean|8.4||0.407|1-Sided|95.0|-12.0||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741971|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-4.4|Standard Error of the Mean|9.5||0.6767|1-Sided|95.0|-20.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742167|NCT00430248|3204444|Superiority or Other||||||<|0.421||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1741972|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-8.5|Standard Error of the Mean|9.8||0.8055|1-Sided|95.0|-24.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741973|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|1.1|Standard Error of the Mean|7.4||0.4393|1-Sided|95.0|-11.2||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741974|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-7.5|Standard Error of the Mean|8.4||0.8117|1-Sided|95.0|-21.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741975|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-10.9|Standard Error of the Mean|8.6||0.8939|1-Sided|95.0|-25.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741976|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-1.4|Standard Error of the Mean|6.6||0.5811|1-Sided|95.0|-12.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741977|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-5.4|Standard Error of the Mean|7.6||0.7615|1-Sided|95.0|-18.1||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741978|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-4.9|Standard Error of the Mean|7.7||0.7374|1-Sided|95.0|-17.7||||Mixed Models Analysis|||Morning PEFR, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741979|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|1.7|Standard Error of the Mean|5.4||0.3795|1-Sided|95.0|-7.4||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741980|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|3.7|Standard Error of the Mean|6.2||0.2768|1-Sided|95.0|-6.6||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741981|NCT00430300|3204420|Superiority or Other||Adjusted Mean Difference|-3.8|Standard Error of the Mean|6.3||0.7292|1-Sided|95.0|-14.3||||Mixed Models Analysis|||Morning PEFR, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741982|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|0.0|Standard Error of the Mean|0.45||0.5014|1-Sided|95.0|-0.75||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741983|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.23|Standard Error of the Mean|0.51||0.6727|1-Sided|95.0|-1.08||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741984|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.47|Standard Error of the Mean|0.52||0.8169|1-Sided|95.0|-1.34||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741985|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|0.21|Standard Error of the Mean|0.44||0.3178|1-Sided|95.0|-0.53||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741986|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.11|Standard Error of the Mean|0.51||0.5848|1-Sided|95.0|-0.95||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741987|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.34|Standard Error of the Mean|0.51||0.7465|1-Sided|95.0|-1.2||||Mixed Models Analysis|||Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741988|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|0.01|Standard Error of the Mean|0.41||0.49|1-Sided|95.0|-0.68||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741989|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.03|Standard Error of the Mean|0.47||0.5283|1-Sided|95.0|-0.82||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741990|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.6|Standard Error of the Mean|0.48||0.8934|1-Sided|95.0|-1.41||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741991|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|0.07|Standard Error of the Mean|0.39||0.4325|1-Sided|95.0|-0.58||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741992|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.31|Standard Error of the Mean|0.44||0.7575|1-Sided|95.0|-1.05||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741993|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.55|Standard Error of the Mean|0.45||0.8851|1-Sided|95.0|-1.3||||Mixed Models Analysis|||Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741994|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.16|Standard Error of the Mean|0.3||0.7054|1-Sided|95.0|-0.66||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741995|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.03|Standard Error of the Mean|0.34||0.53|1-Sided|95.0|-0.59||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741996|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.25|Standard Error of the Mean|0.35||0.7598|1-Sided|95.0|-0.83||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741997|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.13|Standard Error of the Mean|0.31||0.6634|1-Sided|95.0|-0.65||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741998|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.21|Standard Error of the Mean|0.35||0.7226|1-Sided|95.0|-0.8||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1741999|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.26|Standard Error of the Mean|0.36||0.766|1-Sided|95.0|-0.87||||Mixed Models Analysis|||Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742000|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.09|Standard Error of the Mean|0.27||0.6382|1-Sided|95.0|-0.54||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742001|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.15|Standard Error of the Mean|0.3||0.6877|1-Sided|95.0|-0.66||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742002|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|-0.28|Standard Error of the Mean|0.31||0.8136|1-Sided|95.0|-0.79||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742003|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|0.21|Standard Error of the Mean|0.23||0.1796|1-Sided|95.0|-0.17||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742004|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|0.24|Standard Error of the Mean|0.26||0.1831|1-Sided|95.0|-0.2||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742005|NCT00430300|3204421|Superiority or Other||Adjusted Mean Difference|0.16|Standard Error of the Mean|0.27||0.27|1-Sided|95.0|-0.28||||Mixed Models Analysis|||Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742006|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.07|Standard Error of the Mean|0.14||0.3141|1-Sided|95.0|-0.16||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742007|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.05|Standard Error of the Mean|0.16||0.6342|1-Sided|95.0|-0.32||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742008|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.12|Standard Error of the Mean|0.16||0.2228|1-Sided|95.0|-0.14||||Mixed Models Analysis|||Sputum, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742009|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.04|Standard Error of the Mean|0.14||0.3883|1-Sided|95.0|-0.19||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742010|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.09|Standard Error of the Mean|0.16||0.7102|1-Sided|95.0|-0.35||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742011|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.06|Standard Error of the Mean|0.16||0.3545|1-Sided|95.0|-0.21||||Mixed Models Analysis|||Sputum, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742168|NCT00430248|3204445|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742744|NCT00424294|3205333|Superiority or Other|||||||0.733|||||||Chi-squared||||
1742012|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.12|Standard Error of the Mean|0.15||0.2151|1-Sided|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742013|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.09|Standard Error of the Mean|0.17||0.2861|1-Sided|95.0|-0.18||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742014|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.12|Standard Error of the Mean|0.17||0.2359|1-Sided|95.0|-0.16||||Mixed Models Analysis|||Sputum, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742015|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.11|Standard Error of the Mean|0.12||0.1836|1-Sided|95.0|-0.09||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742016|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.16|Standard Error of the Mean|0.14||0.1207|1-Sided|95.0|-0.07||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742017|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.12|Standard Error of the Mean|0.14||0.203|1-Sided|95.0|-0.12||||Mixed Models Analysis|||Sputum, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742018|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.05|Standard Error of the Mean|0.13||0.3597|1-Sided|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742019|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.11|Standard Error of the Mean|0.15||0.2243|1-Sided|95.0|-0.14||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742020|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.02|Standard Error of the Mean|0.16||0.4396|1-Sided|95.0|-0.23||||Mixed Models Analysis|||Sputum, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742021|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.11|Standard Error of the Mean|0.14||0.2221|1-Sided|95.0|-0.12||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742022|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.13|Standard Error of the Mean|0.16||0.2105|1-Sided|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742023|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.12|Standard Error of the Mean|0.16||0.7656|1-Sided|95.0|-0.38||||Mixed Models Analysis|||Sputum, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742024|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.11|Standard Error of the Mean|0.14||0.2281|1-Sided|95.0|-0.13||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742025|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.1|Standard Error of the Mean|0.16||0.2627|1-Sided|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742026|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.07|Standard Error of the Mean|0.16||0.6756|1-Sided|95.0|-0.34||||Mixed Models Analysis|||Sputum, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742027|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.01|Standard Error of the Mean|0.11||0.4785|1-Sided|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742028|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.03|Standard Error of the Mean|0.12||0.393|1-Sided|95.0|-0.17||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742029|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.1|Standard Error of the Mean|0.12||0.7888|1-Sided|95.0|-0.31||||Mixed Models Analysis|||Sputum, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742030|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.11|Standard Error of the Mean|0.15||0.7664|1-Sided|95.0|-0.35||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742031|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.15|Standard Error of the Mean|0.17||0.8104|1-Sided|95.0|-0.42||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742169|NCT00430248|3204445|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742032|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.1|Standard Error of the Mean|0.17||0.7141|1-Sided|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742033|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.09|Standard Error of the Mean|0.12||0.7591|1-Sided|95.0|-0.29||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742034|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.27|Standard Error of the Mean|0.14||0.9717|1-Sided|95.0|-0.5||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742035|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.15|Standard Error of the Mean|0.14||0.8469|1-Sided|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742036|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.16|Standard Error of the Mean|0.14||0.8765|1-Sided|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742037|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.12|Standard Error of the Mean|0.15||0.7906|1-Sided|95.0|-0.38||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742038|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.21|Standard Error of the Mean|0.16||0.9084|1-Sided|95.0|-0.47||||Mixed Models Analysis|||Breathlessness, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742039|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.19|Standard Error of the Mean|0.12||0.9376|1-Sided|95.0|-0.4||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742040|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.34|Standard Error of the Mean|0.14||0.9917|1-Sided|95.0|-0.58||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742041|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.26|Standard Error of the Mean|0.14||0.9619|1-Sided|95.0|-0.5||||Mixed Models Analysis|||Breathlessness, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742042|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.26|Standard Error of the Mean|0.12||0.9833|1-Sided|95.0|-0.46||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742043|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.33|Standard Error of the Mean|0.13||0.9918|1-Sided|95.0|-0.55||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742044|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.32|Standard Error of the Mean|0.14||0.9887|1-Sided|95.0|-0.55||||Mixed Models Analysis|||Breathlessness, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742045|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.12|Standard Error of the Mean|0.12||0.8408|1-Sided|95.0|-0.32||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742046|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.27|Standard Error of the Mean|0.14||0.9743|1-Sided|95.0|-0.49||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742047|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.24|Standard Error of the Mean|0.14||0.9548|1-Sided|95.0|-0.47||||Mixed Models Analysis|||Breathlessness, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742048|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.01|Standard Error of the Mean|0.11||0.5373|1-Sided|95.0|-0.2||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742049|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.09|Standard Error of the Mean|0.13||0.7678|1-Sided|95.0|-0.31||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742050|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.11|Standard Error of the Mean|0.13||0.8082|1-Sided|95.0|-0.33||||Mixed Models Analysis|||Breathlessness, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742051|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.07|Standard Error of the Mean|0.1||0.775|1-Sided|95.0|-0.23||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742052|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.1|Standard Error of the Mean|0.11||0.8106|1-Sided|95.0|-0.28||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742053|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.24|Standard Error of the Mean|0.11||0.9838|1-Sided|95.0|-0.42||||Mixed Models Analysis|||Breathlessness, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742054|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.18|Standard Error of the Mean|0.16||0.8677|1-Sided|95.0|-0.44||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742055|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.1|Standard Error of the Mean|0.18||0.7191|1-Sided|95.0|-0.4||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742056|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.21|Standard Error of the Mean|0.18||0.8775|1-Sided|95.0|-0.51||||Mixed Models Analysis|||Cough, Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742057|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.05|Standard Error of the Mean|0.15||0.6375|1-Sided|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742058|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.19|Standard Error of the Mean|0.17||0.8634|1-Sided|95.0|-0.47||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742059|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.23|Standard Error of the Mean|0.17||0.9031|1-Sided|95.0|-0.52||||Mixed Models Analysis|||Cough, Change at Week 7: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742060|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.11|Standard Error of the Mean|0.16||0.2557|1-Sided|95.0|-0.17||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742061|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.01|Standard Error of the Mean|0.19||0.4821|1-Sided|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742062|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.07|Standard Error of the Mean|0.19||0.6485|1-Sided|95.0|-0.39||||Mixed Models Analysis|||Cough, Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742063|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.1|Standard Error of the Mean|0.16||0.2684|1-Sided|95.0|-0.17||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742064|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.03|Standard Error of the Mean|0.18||0.5665|1-Sided|95.0|-0.33||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742065|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.14|Standard Error of the Mean|0.18||0.7726|1-Sided|95.0|-0.45||||Mixed Models Analysis|||Cough, Change at Week 5: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742066|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.21|Standard Error of the Mean|0.12||0.9534|1-Sided|95.0|-0.41||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742067|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.17|Standard Error of the Mean|0.14||0.8961|1-Sided|95.0|-0.4||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742068|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.26|Standard Error of the Mean|0.14||0.9648|1-Sided|95.0|-0.49||||Mixed Models Analysis|||Cough, Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742069|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.07|Standard Error of the Mean|0.14||0.6838|1-Sided|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742070|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.06|Standard Error of the Mean|0.16||0.6391|1-Sided|95.0|-0.32||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742071|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.22|Standard Error of the Mean|0.16||0.9102|1-Sided|95.0|-0.49||||Mixed Models Analysis|||Cough, Change at Week 3: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742170|NCT00430248|3204445|Superiority or Other||||||<|0.083||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742072|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.12|Standard Error of the Mean|0.14||0.1802|1-Sided|95.0|-0.1||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742073|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|0.08|Standard Error of the Mean|0.16||0.3151|1-Sided|95.0|-0.18||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742074|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.08|Standard Error of the Mean|0.16||0.6986|1-Sided|95.0|-0.34||||Mixed Models Analysis|||Cough, Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742075|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.01|Standard Error of the Mean|0.13||0.5448|1-Sided|95.0|-0.23||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742076|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.05|Standard Error of the Mean|0.15||0.6334|1-Sided|95.0|-0.3||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742077|NCT00430300|3204422|Superiority or Other||Adjusted Mean Difference|-0.17|Standard Error of the Mean|0.15||0.8757|1-Sided|95.0|-0.42||||Mixed Models Analysis|||Cough, Change at Week 1: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742078|NCT00430300|3204423|Superiority or Other||Adjusted Mean Difference|-1.0|Standard Error of the Mean|0.8||0.899|1-Sided|95.0|-2.2||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742079|NCT00430300|3204423|Superiority or Other||Adjusted Mean Difference|-0.3|Standard Error of the Mean|0.9||0.6378|1-Sided|95.0|-1.7||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742080|NCT00430300|3204423|Superiority or Other||Adjusted Mean Difference|-1.6|Standard Error of the Mean|0.9||0.9657|1-Sided|95.0|-3.1||||Mixed Models Analysis|||TDI at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742081|NCT00430300|3204423|Superiority or Other||Adjusted Mean Difference|-0.6|Standard Error of the Mean|0.6||0.8302|1-Sided|95.0|-1.7||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742082|NCT00430300|3204423|Superiority or Other||Adjusted Mean Difference|-0.2|Standard Error of the Mean|0.7||0.5957|1-Sided|95.0|-1.4||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742083|NCT00430300|3204423|Superiority or Other||Adjusted Mean Difference|0.1|Standard Error of the Mean|0.7||0.4401|1-Sided|95.0|-1.1||||Mixed Models Analysis|||TDI at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742084|NCT00430300|3204423|Superiority or Other||Adjusted Mean Difference|-1.1|Standard Error of the Mean|0.5||0.9759|1-Sided|95.0|-2.0||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742085|NCT00430300|3204423|Superiority or Other||Adjusted Mean Difference|-0.5|Standard Error of the Mean|0.6||0.8055|1-Sided|95.0|-1.5||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742086|NCT00430300|3204423|Superiority or Other||Adjusted Mean Difference|-1.4|Standard Error of the Mean|0.6||0.9885|1-Sided|95.0|-2.4||||Mixed Models Analysis|||TDI at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742087|NCT00430300|3204431|Superiority or Other||Adjusted Mean Difference|-0.02|Standard Error of the Mean|0.06||0.6164|1-Sided|95.0|-0.11||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742088|NCT00430300|3204431|Superiority or Other||Adjusted Mean Difference|0.01|Standard Error of the Mean|0.06||0.4686|1-Sided|95.0|-0.1||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742089|NCT00430300|3204431|Superiority or Other||Adjusted Mean Difference|-0.02|Standard Error of the Mean|0.07||0.637|1-Sided|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742090|NCT00430300|3204431|Superiority or Other||Adjusted Mean Difference|-0.01|Standard Error of the Mean|0.04||0.5632|1-Sided|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742091|NCT00430300|3204431|Superiority or Other||Adjusted Mean Difference|-0.02|Standard Error of the Mean|0.05||0.6562|1-Sided|95.0|-0.1||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742171|NCT00430248|3204446|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1743959|NCT00408876|3207586|Superiority or Other|||||||0.015|||||||t-test, 2 sided||||
1742093|NCT00430300|3204431|Superiority or Other||Adjusted Mean Difference|-0.05|Standard Error of the Mean|0.04||0.8572|1-Sided|95.0|-0.12||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742094|NCT00430300|3204431|Superiority or Other||Adjusted Mean Difference|-0.11|Standard Error of the Mean|0.05||0.988|1-Sided|95.0|-0.2||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742095|NCT00430300|3204431|Superiority or Other||Adjusted Mean Difference|-0.01|Standard Error of the Mean|0.05||0.5549|1-Sided|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742096|NCT00430300|3204432|Superiority or Other||Adjusted Mean Difference|-0.03|Standard Error of the Mean|0.11||0.6113|1-Sided|95.0|-0.21||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742097|NCT00430300|3204432|Superiority or Other||Adjusted Mean Difference|0.14|Standard Error of the Mean|0.12||0.1237|1-Sided|95.0|-0.06||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742098|NCT00430300|3204432|Superiority or Other||Adjusted Mean Difference|0.12|Standard Error of the Mean|0.12||0.1735|1-Sided|95.0|-0.09||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742099|NCT00430300|3204432|Superiority or Other||Adjusted Mean Difference|-0.04|Standard Error of the Mean|0.09||0.6563|1-Sided|95.0|-0.2||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742100|NCT00430300|3204432|Superiority or Other||Adjusted Mean Difference|0.05|Standard Error of the Mean|0.11||0.3148|1-Sided|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742101|NCT00430300|3204432|Superiority or Other||Adjusted Mean Difference|0.05|Standard Error of the Mean|0.11||0.3248|1-Sided|95.0|-0.13||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742102|NCT00430300|3204432|Superiority or Other||Adjusted Mean Difference|-0.08|Standard Error of the Mean|0.09||0.8168|1-Sided|95.0|-0.22||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742103|NCT00430300|3204432|Superiority or Other||Adjusted Mean Difference|0.07|Standard Error of the Mean|0.1||0.2539|1-Sided|95.0|-0.1||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742104|NCT00430300|3204432|Superiority or Other||Adjusted Mean Difference|0.01|Standard Error of the Mean|0.1||0.4492|1-Sided|95.0|-0.16||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742105|NCT00430300|3204432|Superiority or Other||Adjusted Mean Difference|0.09|Standard Error of the Mean|0.09||0.1682|1-Sided|95.0|-0.06||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742106|NCT00430300|3204432|Superiority or Other||Adjusted Mean Difference|0.08|Standard Error of the Mean|0.1||0.2149|1-Sided|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742107|NCT00430300|3204432|Superiority or Other||Adjusted Mean Difference|0.14|Standard Error of the Mean|0.1||0.0938|1-Sided|95.0|-0.03||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742108|NCT00430300|3204433|Superiority or Other||Adjusted Mean Difference|0.12|Standard Error of the Mean|0.11||0.1363|1-Sided|95.0|-0.06||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742109|NCT00430300|3204433|Superiority or Other||Adjusted Mean Difference|0.07|Standard Error of the Mean|0.12||0.2772|1-Sided|95.0|-0.13||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742110|NCT00430300|3204433|Superiority or Other||Adjusted Mean Difference|0.18|Standard Error of the Mean|0.13||0.0881|1-Sided|95.0|-0.04||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742111|NCT00430300|3204433|Superiority or Other||Adjusted Mean Difference|-0.04|Standard Error of the Mean|0.09||0.6719|1-Sided|95.0|-0.19||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742112|NCT00430300|3204433|Superiority or Other||Adjusted Mean Difference|-0.02|Standard Error of the Mean|0.1||0.5742|1-Sided|95.0|-0.19||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742113|NCT00430300|3204433|Superiority or Other||Adjusted Mean Difference|-0.04|Standard Error of the Mean|0.11||0.6348|1-Sided|95.0|-0.22||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742114|NCT00430300|3204433|Superiority or Other||Adjusted Mean Difference|-0.07|Standard Error of the Mean|0.09||0.7973|1-Sided|95.0|-0.22||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742115|NCT00430300|3204433|Superiority or Other||Adjusted Mean Difference|0.1|Standard Error of the Mean|0.1||0.1548|1-Sided|95.0|-0.06||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742116|NCT00430300|3204433|Superiority or Other||Adjusted Mean Difference|-0.19|Standard Error of the Mean|0.1||0.9686|1-Sided|95.0|-0.36||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742117|NCT00430300|3204433|Superiority or Other||Adjusted Mean Difference|-0.12|Standard Error of the Mean|0.09||0.9153|1-Sided|95.0|-0.27||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742118|NCT00430300|3204433|Superiority or Other||Adjusted Mean Difference|-0.16|Standard Error of the Mean|0.1||0.9469|1-Sided|95.0|-0.33||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742119|NCT00430300|3204433|Superiority or Other||Adjusted Mean Difference|-0.15|Standard Error of the Mean|0.1||0.9362|1-Sided|95.0|-0.32||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742120|NCT00430300|3204434|Superiority or Other||Adjusted Mean Difference|0.14|Standard Error of the Mean|0.09||0.0724|1-Sided|95.0|-0.02||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742121|NCT00430300|3204434|Superiority or Other||Adjusted Mean Difference|0.07|Standard Error of the Mean|0.1||0.2616|1-Sided|95.0|-0.11||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742122|NCT00430300|3204434|Superiority or Other||Adjusted Mean Difference|0.18|Standard Error of the Mean|0.11||0.054|1-Sided|95.0|0.0||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742123|NCT00430300|3204434|Superiority or Other||Adjusted Mean Difference|-0.02|Standard Error of the Mean|0.07||0.5806|1-Sided|95.0|-0.14||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742124|NCT00430300|3204434|Superiority or Other||Adjusted Mean Difference|0.05|Standard Error of the Mean|0.08||0.2734|1-Sided|95.0|-0.09||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742125|NCT00430300|3204434|Superiority or Other||Adjusted Mean Difference|0.03|Standard Error of the Mean|0.09||0.3499|1-Sided|95.0|-0.11||||Mixed Models Analysis|||Change at Week 6: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742126|NCT00430300|3204434|Superiority or Other||Adjusted Mean Difference|-0.04|Standard Error of the Mean|0.06||0.7403|1-Sided|95.0|-0.15||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742127|NCT00430300|3204434|Superiority or Other||Adjusted Mean Difference|0.04|Standard Error of the Mean|0.07||0.2991|1-Sided|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742128|NCT00430300|3204434|Superiority or Other||Adjusted Mean Difference|-0.11|Standard Error of the Mean|0.07||0.9283|1-Sided|95.0|-0.23||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742129|NCT00430300|3204434|Superiority or Other||Adjusted Mean Difference|-0.03|Standard Error of the Mean|0.06||0.6841|1-Sided|95.0|-0.13||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742130|NCT00430300|3204434|Superiority or Other||Adjusted Mean Difference|-0.1|Standard Error of the Mean|0.07||0.9134|1-Sided|95.0|-0.21||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742131|NCT00430300|3204434|Superiority or Other||Adjusted Mean Difference|-0.05|Standard Error of the Mean|0.07||0.7444|1-Sided|95.0|-0.16||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742132|NCT00430300|3204435|Superiority or Other||Adjusted Mean Difference|0.1|Standard Error of the Mean|0.06||0.055|1-Sided|95.0|0.0||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742133|NCT00430300|3204435|Superiority or Other||Adjusted Mean Difference|-0.01|Standard Error of the Mean|0.07||0.53|1-Sided|95.0|-0.12||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742134|NCT00430300|3204435|Superiority or Other||Adjusted Mean Difference|0.08|Standard Error of the Mean|0.07||0.1244|1-Sided|95.0|-0.04||||Mixed Models Analysis|||Change at Week 8: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742135|NCT00430300|3204435|Superiority or Other||Adjusted Mean Difference|0.0|Standard Error of the Mean|0.05||0.5134|1-Sided|95.0|-0.08||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742136|NCT00430300|3204435|Superiority or Other||Adjusted Mean Difference|-0.04|Standard Error of the Mean|0.05||0.7499|1-Sided|95.0|-0.13||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742137|NCT00430300|3204435|Superiority or Other||Adjusted Mean Difference|-0.06|Standard Error of the Mean|0.06||0.8612|1-Sided|95.0|-0.15||||Mixed Models Analysis|||Change at Week 4: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742138|NCT00430300|3204435|Superiority or Other||Adjusted Mean Difference|0.01|Standard Error of the Mean|0.04||0.387|1-Sided|95.0|-0.06||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742139|NCT00430300|3204435|Superiority or Other||Adjusted Mean Difference|-0.09|Standard Error of the Mean|0.05||0.9737|1-Sided|95.0|-0.17||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742140|NCT00430300|3204435|Superiority or Other||Adjusted Mean Difference|-0.01|Standard Error of the Mean|0.05||0.5849|1-Sided|95.0|-0.09||||Mixed Models Analysis|||Change at Week 2: Analysis was performed using longitudinal mixed effect model with baseline value, treatment, week, and treatment by week as fixed effects and participants as random effect.|
1742141|NCT00430300|3204436|Superiority or Other||NDLM estimate difference|-0.051||||0.0009|2-Sided|95.0|-0.1298|0.029|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.|
1742142|NCT00430300|3204436|Superiority or Other||NDLM estimate difference|-0.0389||||0.0056|2-Sided|95.0|-0.1299|0.0471|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.|
1742143|NCT00430300|3204436|Superiority or Other||NDLM estimate difference|-0.0087||||0.0284|2-Sided|95.0|-0.0943|0.0774|||Bayesian NDLM model|||The Bayesian normal dynamic linear model (NDLM) was used for analysis. 95% credible intervals of the effect size and the posterior distribution were calculated. Posterior distribution was used to calculate a probability (presented as p value) that the dose gives a difference of 0.075 liter from placebo.|
1742144|NCT00430248|3204437|Superiority or Other||||||<|0.001||||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA||||
1742145|NCT00430248|3204437|Superiority or Other||||||<|0.001||||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA||||
1742146|NCT00430248|3204437|Superiority or Other||||||<|0.05||||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA||||
1742147|NCT00430248|3204438|Superiority or Other||||||<|0.001||||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA||||
1742148|NCT00430248|3204438|Superiority or Other||||||<|0.001||||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA||||
1742149|NCT00430248|3204438|Superiority or Other||||||<|0.153||||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA||||
1742150|NCT00430248|3204439|Superiority or Other||||||<|0.001||||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA||||
1742151|NCT00430248|3204439|Superiority or Other||||||<|0.001||||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA||||
1742152|NCT00430248|3204439|Superiority or Other||||||<|0.685||||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA||||
1742153|NCT00430248|3204440|Superiority or Other||||||<|0.001||||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA||||
1742154|NCT00430248|3204440|Superiority or Other||||||<|0.001||||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA||||
1742155|NCT00430248|3204440|Superiority or Other||||||<|0.079||||||P-value is from contrast within the framework of the ANOVA with significance at the 0.05 level.|ANOVA||||
1742156|NCT00430248|3204441|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742157|NCT00430248|3204441|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742158|NCT00430248|3204441|Superiority or Other||||||<|0.196||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742159|NCT00430248|3204442|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742160|NCT00430248|3204442|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742161|NCT00430248|3204442|Superiority or Other||||||<|0.195||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742162|NCT00430248|3204443|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742163|NCT00430248|3204443|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742164|NCT00430248|3204443|Superiority or Other||||||<|0.52||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742165|NCT00430248|3204444|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742173|NCT00430248|3204446|Superiority or Other||||||<|0.041||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742174|NCT00430248|3204447|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742175|NCT00430248|3204447|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742176|NCT00430248|3204447|Superiority or Other||||||<|0.428||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742177|NCT00430248|3204448|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742178|NCT00430248|3204448|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742179|NCT00430248|3204448|Superiority or Other||||||<|0.05||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742180|NCT00430248|3204449|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742181|NCT00430248|3204449|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742182|NCT00430248|3204449|Superiority or Other||||||<|0.426||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742183|NCT00430248|3204450|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742184|NCT00430248|3204450|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742185|NCT00430248|3204450|Superiority or Other||||||<|0.578||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742186|NCT00430248|3204451|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742187|NCT00430248|3204451|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742188|NCT00430248|3204451|Superiority or Other||||||<|0.031||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742189|NCT00430248|3204452|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742190|NCT00430248|3204452|Superiority or Other||||||<|0.001||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742191|NCT00430248|3204452|Superiority or Other||||||<|0.021||||||The a priori threshold for statistical significance was 0.05 (two-tailed).|Fisher Exact||||
1742192|NCT00430248|3204453|Superiority or Other||Difference in percentage|21.9|||<|0.001||95.0|17.0|26.8||Comparisons between treatment groups were performed using Fisher’s exact test (two-tailed 0.05 significance level).|Fisher Exact||||
1742193|NCT00430248|3204453|Superiority or Other||Difference in percentage|24.9|||<|0.001||95.0|20.1|29.8||Comparisons between treatment groups were performed using Fisher’s exact test (two-tailed 0.05 significance level).|Fisher Exact||||
1742194|NCT00430248|3204453|Superiority or Other||||||<|0.233||||||The test for superiority was performed using Fisher's exact test (two-tailed 0.05 significance level).|Fisher Exact||||
1742195|NCT00430248|3204453|Non-Inferiority or Equivalence|Noninferiority of febuxostat 40 mg to allopurinol was declared if the value of the lower bound of the 95% confidence interval for the difference was greater than -10%.|Difference in percentage|3.1|||<|||95.0|-1.9|8.1||||||The primary comparison was between febuxostat 40 mg and allopurinol treatment groups.|
1742196|NCT00430092|3204462|Superiority or Other||||||<|0.0001|||||||Mantel Haenszel||||
1742197|NCT00429923|3204470|Superiority or Other|||||||0.0014|||||||Mantel Haenszel||||
1742198|NCT00429364|3204500|Superiority or Other|||||||0.1|||||||Log Rank||||
1742199|NCT00429364|3204502|Superiority or Other|||||||0.32|||||||Log Rank||||
1742200|NCT00429364|3204504|Superiority or Other|||||||0.13|||||||Log Rank||||
1742201|NCT00429364|3204506|Superiority or Other|||||||0.16|||||||Log Rank||||
1742202|NCT00429364|3204508|Superiority or Other|||||||0.59|||||||Mixed Models Analysis||||
1742203|NCT00429364|3204509|Superiority or Other|||||||0.49|||||||Mixed Models Analysis||||
1742204|NCT00429364|3204510|Superiority or Other|||||||0.64|||||||Mixed Models Analysis||||
1742205|NCT00429364|3204511|Superiority or Other|||||||0.82|||||||Mixed Models Analysis||||
1742206|NCT00429364|3204512|Superiority or Other|||||||0.13|||||||Mixed Models Analysis||||
1742207|NCT00429364|3204513|Superiority or Other|||||||0.65|||||||Mixed Models Analysis||||
1742208|NCT00429364|3204514|Superiority or Other|||||||0.13|||||||Mixed Models Analysis||||
1742209|NCT00429364|3204515|Superiority or Other|||||||0.45|||||||Mixed Models Analysis||||
1742210|NCT00429364|3204516|Superiority or Other|||||||0.96||||||Regression model adjusted for age at study visit.|Mixed Models Analysis||||
1742211|NCT00429364|3204517|Superiority or Other|||||||0.29||||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis||||
1742212|NCT00429364|3204518|Superiority or Other|||||||0.002||||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis||||
1742213|NCT00429364|3204519|Superiority or Other||||||<|0.001||||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis||||
1742214|NCT00429364|3204520|Superiority or Other|||||||0.3||||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis||||
1742215|NCT00429364|3204521|Superiority or Other|||||||0.15||||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis||||
1742216|NCT00429364|3204522|Superiority or Other|||||||0.2||||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis||||
1742217|NCT00429364|3204523|Superiority or Other|||||||0.08||||||P values are based on a linear regression mixed-effect model comparing slopes under compound symmetry, with adjustment for baseline.|Mixed Models Analysis||||
1742218|NCT00429299|3204531|Superiority or Other||percentage of participants|46.7|||||2-Sided|90.0|34.4|58.9|||||The estimated value represents the percentage of particpants in the CT plus traztuzumab plus lapatinib 1000 mg treatment group with pathological complete response.||
1742219|NCT00429299|3204531|Superiority or Other||percentage of participants|26.3||||||90.0|14.5|38.1|||||The estimated value represents the percentage of particpants in the CT plus lapatinib 1500 mg treatment group with pathological complete response.||
1742220|NCT00429299|3204531|Non-Inferiority or Equivalence|An exploratory comparison between the combined two single anti-HER2 arms and the dual anti-HER2 arm was performed (Arm 3 versus Arms 1 and 2).|percentage of participants|25.0||||0.019||90.0|13.1|36.9||Exploratory analysis|Chi-squared||The estimated value represents the percentage of particpants in the CT plus trastuzumab treatment group with pathological complete response.||
1742221|NCT00429273|3204532|Other|Test for differences in treatment outcomes between three different tx|F-Value for variance component|18.9|||<|0.01|2-Sided||||||Mixed Models Analysis|||Analyses are based on a generalized linear mixed model (GLMM) modelling the effects of the medication when calibrated to optimal dosage and controlling for time effects and within-subject effects. The design is a combined within-between subject design, where each participant is exposed to, and provides information about multiple tx modalities.|
1742222|NCT00429169|3204537|Superiority or Other||regression coefficient|-0.29||||0.03|2-Sided|95.0|-0.57|-0.023||The p-value applies to the interaction term of Treatment X Baseline Suicidal Ideation severity.|Mixed Models Analysis|||Generalized least squares model of Scale for Suicidal Ideation score during 8-week acute treatment of major depressive disorder.|
1742223|NCT00428974|3204549|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1742224|NCT00428948|3204552|Superiority or Other||Risk Ratio (RR)|1.1||||0.7532|2-Sided|95.0|0.602|2.017|||Cochran-Mantel-Haenszel||Tolvaptan divided by placebo.|The null hypothesis was that there was no difference in the percentage of participants with a clinically sustained decrease of blood pressure leading to a sustained reduction in antihypertensive therapy between the tolvaptan group and the placebo group.|
1742225|NCT00428948|3204553|Superiority or Other||Hazard Ratio (HR)|0.996||||0.9704|2-Sided|95.0|0.805|1.233|||Recurrent event analysis||Derived from rate and mean model of time to recurrent event analysis with factor treatment.|The null hypothesis was that there was no difference in the hypertensive events per 100 follow-up years in non-hypertensive participants between the tolvaptan group and the placebo group.|
1742226|NCT00428948|3204554|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.1604|2-Sided|95.0|-0.2|0.03|||ANCOVA|The analysis included baseline renal pain as a covariate.|Derived from ANCOVA with factors of treatment and baseline stratification factor interaction and covariate renal pain baseline.|The null hypothesis was that there was no difference in the change in renal pain between the tolvaptan group and the placebo group.|
1742227|NCT00428948|3204555|Superiority or Other||Difference in slope|-0.246||||0.552|2-Sided|95.0|-1.059|0.566|||Mixed Models Analysis|Derived from testing the time treatment interaction using linear mixed model in which both intercept and slope are fixed and random effects.|Placebo minus tolvaptan.|The null hypothesis was that there was no difference in mean arterial blood pressure in non-hypertensive participants between the tolvaptan group and the placebo group.|
1742228|NCT00428948|3204556|Superiority or Other||Difference in slope|0.977|||<|0.0001|2-Sided|95.0|0.597|1.357|||Mixed Models Analysis|Derived from testing the time treatment interaction using linear mixed model in which both intercept and slope are fixed and random effects.||The null hypothesis was that there was no difference in the change in renal function per year between the tolvaptan group and the placebo group.|
1742229|NCT00428948|3204557|Superiority or Other||Hazard Ratio (HR)|0.865||||0.0095|2-Sided|95.0|0.775|0.965|||Recurrent event analysis||Tolvaptan divided by placebo.|The null hypothesis was that there was no difference in the ADPKD clinical progression events/100 follow-up years between the tolvaptan group and the placebo group.|
1742230|NCT00428948|3204558|Superiority or Other||Mean Difference (Final Values)|-2.708|||<|0.0001|2-Sided|95.0|-3.269|-2.147|||Linear mixed model||The variance of the random effect intercept was zero and resulted in a non-positive, definite variance-covariance matrix for the random effects.|The null hypothesis was that there was no difference in the percentage change per year in total kidney volume between the tolvaptan group and the placebo group.|
1742231|NCT00428597|3204588|Superiority or Other||Mean Difference (Final Values)|-3.5128||||0.3711|2-Sided|95.0|-11.2|4.2||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742232|NCT00428597|3204589|Superiority or Other||Mean Difference (Final Values)|1.1463||||0.6939|2-Sided|95.0|-4.6|6.9||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742233|NCT00428597|3204590|Superiority or Other||Mean Difference (Final Values)|7.753||||0.0372|2-Sided|95.0|0.5|15.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742248|NCT00428597|3204607|Superiority or Other||Hazard Ratio (HR)|0.418||||0.000118|2-Sided|95.0|0.263|0.662||Log-rank test statistic and 2-sided p-value from the unstratified log-rank test|Log Rank||Hazard ratio based on the Cox Proportional hazards model||
1742249|NCT00428584|3204613|Superiority or Other|||||||0.338|||||||ANOVA||||
1743960|NCT00408876|3207586|Superiority or Other|||||||0.015|||||||t-test, 2 sided||||
1742234|NCT00428597|3204591|Superiority or Other||Mean Difference (Final Values)|0.2778||||0.9367|2-Sided|95.0|-6.6|7.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742235|NCT00428597|3204592|Superiority or Other||Mean Difference (Final Values)|1.7816||||0.6138|2-Sided|95.0|-5.1|8.7||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742236|NCT00428597|3204593|Superiority or Other||Mean Difference (Final Values)|5.23||||0.1339|2-Sided|95.0|-1.6|12.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742237|NCT00428597|3204594|Superiority or Other||Mean Difference (Final Values)|21.3801|||<|0.0001|2-Sided|95.0|14.3|28.4||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742238|NCT00428597|3204595|Superiority or Other||Mean Difference (Final Values)|-4.0035||||0.1936|2-Sided|95.0|-10.0|2.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742239|NCT00428597|3204596|Superiority or Other||Mean Difference (Final Values)|1.88||||0.6545|2-Sided|95.0|-6.4|10.1||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742240|NCT00428597|3204597|Superiority or Other||Mean Difference (Final Values)|-1.6672||||0.6487|2-Sided|95.0|-8.9|5.5||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742241|NCT00428597|3204598|Superiority or Other||Mean Difference (Final Values)|1.5113||||0.7113|2-Sided|95.0|-6.5|9.5||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742242|NCT00428597|3204599|Superiority or Other||Mean Difference (Final Values)|2.7911||||0.323|2-Sided|95.0|-2.8|8.3||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742243|NCT00428597|3204600|Superiority or Other||Mean Difference (Final Values)|-3.5575||||0.3008|2-Sided|95.0|-10.3|3.2||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742244|NCT00428597|3204601|Superiority or Other||Mean Difference (Final Values)|-1.4404||||0.6058|2-Sided|95.0|-6.9|4.0||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742245|NCT00428597|3204602|Superiority or Other||Mean Difference (Final Values)|1.1543||||0.6799|2-Sided|95.0|-4.3|6.6||From repeated measures mixed-effects with intercept term, treatment, time from first dose, treatment-by-time interaction and baseline score (intercept and time from dose as random effects). No p-value adjustments were made for multiple comparisons.|Repeated Measures Mixed-Effects Model||Estimated mean difference with 95% CI and p-value were obtained from the repeated measures mixed-effects model using data from Cycle 2 through Cycle 10.|Cycle 2 through Cycle 10|
1742246|NCT00428597|3204603|Superiority or Other||Hazard Ratio (HR)|0.409||||0.0204|2-Sided|95.0|0.187|0.894||2-sided p-value from the unstratified log-rank test.|Log Rank||Hazard ratio based on the Cox Proportional hazards model.||
1742247|NCT00428597|3204606|Superiority or Other||Objective Response Rate (ORR) (percent)|9.3|||||2-Sided|95.0|4.1|17.5|||||Confidence interval (CI) using exact method based on binomial distribution.||
1742250|NCT00428584|3204614|Superiority or Other|||||||0.451||||||No pain is defined as a VAS = 0 for all 21 full dose injections.|Cochran-Mantel-Haenszel||||
1742251|NCT00428584|3204615|Superiority or Other|||||||0.838|||||||ANOVA||||
1742252|NCT00428584|3204616|Superiority or Other|||||||0.484|||||||ANOVA||||
1742253|NCT00428584|3204617|Superiority or Other|||||||0.524||||||P value refers to mean change to 30 minute post injection|ANOVA|||The primary efficacy endpoint was analyzed by using a two-way ANOVA model on ranked data including treatment group and site as fixed effect.|
1742254|NCT00428116|3204642|Superiority or Other|||||||0.29|||||||Log Rank|||Death|
1742255|NCT00428116|3204642|Superiority or Other|||||||0.77|||||||Regression, Cox|||Diarrhea|
1742256|NCT00428116|3204642|Superiority or Other|||||||0.6|||||||Regression, Cox|||Pneumonia|
1742257|NCT00428116|3204642|Superiority or Other|||||||0.6|||||||Cox regression Anderson Gill|||Pneumonia|
1742258|NCT00428116|3204642|Superiority or Other|||||||0.39|||||||log rank or Cox regression|incidence with Cox regression utilized Anderson-Gill method to handle recurrent events||SAEs|
1742259|NCT00428116|3204643|Superiority or Other|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||HAZ score at 18 months|
1742260|NCT00428116|3204643|Superiority or Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||WAZ-score comparison at 18 months|
1742261|NCT00428090|3204654|Superiority or Other||Mean Difference (Final Values)|0.0||||0.864|2-Sided|95.0|-0.1|0.2|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742262|NCT00428090|3204654|Superiority or Other||Mean Difference (Final Values)|0.0||||0.846|2-Sided|95.0|-0.1|0.1|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742263|NCT00428090|3204654|Superiority or Other||Mean Difference (Final Values)|0.1||||0.139|2-Sided|95.0|0.0|0.2|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742264|NCT00428090|3204655|Superiority or Other||Mean Difference (Final Values)|1.0||||0.03|2-Sided|95.0|0.1|1.8|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742265|NCT00428090|3204655|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.71|2-Sided|95.0|-0.8|0.6|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742266|NCT00428090|3204655|Superiority or Other||Mean Difference (Final Values)|0.0||||0.886|2-Sided|95.0|-0.7|0.6|||ANCOVA|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742267|NCT00428090|3204656|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.427|2-Sided|95.0|-2.2|0.9||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742268|NCT00428090|3204656|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.353|2-Sided|95.0|-1.9|0.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742269|NCT00428090|3204656|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.196|2-Sided|95.0|-2.0|0.4||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742270|NCT00428090|3204656|Superiority or Other||Mean Difference (Final Values)|0.0||||0.993|2-Sided|95.0|-1.2|1.1||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742271|NCT00428090|3204656|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.278|2-Sided|95.0|-1.6|0.5||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742272|NCT00428090|3204656|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.027|2-Sided|95.0|-2.1|-0.1||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742273|NCT00428090|3204658|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.898|2-Sided|95.0|-5.8|5.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742335|NCT00428090|3204666|Superiority or Other||Mean Difference (Final Values)|0.0||||0.913|2-Sided|95.0|-0.3|0.3||Comparison between Placebo and RSG XR 2 mg in All except e4/e4’s cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|||
1742274|NCT00428090|3204658|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.441|2-Sided|95.0|-5.9|2.6||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742275|NCT00428090|3204658|Superiority or Other||Mean Difference (Final Values)|-2.6||||0.198|2-Sided|95.0|-6.6|1.4||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742276|NCT00428090|3204658|Superiority or Other||Mean Difference (Final Values)|-4.0||||0.13|2-Sided|95.0|-9.3|1.2||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742277|NCT00428090|3204658|Superiority or Other||Mean Difference (Final Values)|0.3||||0.883|2-Sided|95.0|-3.2|3.7||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742278|NCT00428090|3204658|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.493|2-Sided|95.0|-4.6|2.2||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742279|NCT00428090|3204659|Superiority or Other||Mean Difference (Final Values)|0.02||||0.374|2-Sided|95.0|-0.03|0.07||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742280|NCT00428090|3204659|Superiority or Other||Mean Difference (Final Values)|0.0||||0.958|2-Sided|95.0|-0.05|0.05||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742281|NCT00428090|3204659|Superiority or Other||Mean Difference (Final Values)|0.03||||0.134|2-Sided|95.0|-0.01|0.07||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742282|NCT00428090|3204659|Superiority or Other||Mean Difference (Final Values)|0.03||||0.187|2-Sided|95.0|-0.02|0.09||Comparison between Placebo and Donepezil 10 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742283|NCT00428090|3204659|Superiority or Other||Mean Difference (Final Values)|0.04||||0.094|2-Sided|95.0|-0.01|0.08||Comparison between Placebo and RSG XR 8 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742284|NCT00428090|3204659|Superiority or Other||Mean Difference (Final Values)|0.03||||0.199|2-Sided|95.0|-0.01|0.07||Comparison between Placebo and RSG XR 2 mg at Week 12 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742285|NCT00428090|3204660|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.306|2-Sided|95.0|-1.5|0.5||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742286|NCT00428090|3204660|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.819|2-Sided|95.0|-0.8|0.6||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742287|NCT00428090|3204660|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.288|2-Sided|95.0|-1.1|0.3||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742288|NCT00428090|3204660|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.189|2-Sided|95.0|-1.7|0.3||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742356|NCT00427934|3204715|Superiority or Other||Mean Difference (Final Values)|-0.31||||0.21||90.0|-0.72|0.1||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 8|
1743961|NCT00408876|3207586|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1742289|NCT00428090|3204660|Superiority or Other||Mean Difference (Final Values)|0.7||||0.032|2-Sided|95.0|0.1|1.4||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742290|NCT00428090|3204660|Superiority or Other||Mean Difference (Final Values)|0.6||||0.109|2-Sided|95.0|-0.1|1.2||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742291|NCT00428090|3204660|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.325|2-Sided|95.0|-1.3|0.4||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742292|NCT00428090|3204660|Superiority or Other||Mean Difference (Final Values)|0.4||||0.194|2-Sided|95.0|-0.2|1.1||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742293|NCT00428090|3204660|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.635|2-Sided|95.0|-0.8|0.5||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742294|NCT00428090|3204661|Superiority or Other||Mean Difference (Final Values)|3.6||||0.078|2-Sided|95.0|-0.4|7.5||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742295|NCT00428090|3204661|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.944|2-Sided|95.0|-3.0|2.8||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742296|NCT00428090|3204661|Superiority or Other||Mean Difference (Final Values)|1.3||||0.385|2-Sided|95.0|-1.6|4.2||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742297|NCT00428090|3204661|Superiority or Other||Mean Difference (Final Values)|3.7||||0.024|2-Sided|95.0|0.5|7.0||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742298|NCT00428090|3204661|Superiority or Other||Mean Difference (Final Values)|0.9||||0.489|2-Sided|95.0|-1.7|3.6||Comparison between Placebo and RSG XR 8 mg in at Week 16 Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742299|NCT00428090|3204661|Superiority or Other||Mean Difference (Final Values)|0.9||||0.498|2-Sided|95.0|-1.8|3.6||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742300|NCT00428090|3204661|Superiority or Other||Mean Difference (Final Values)|1.3||||0.279|2-Sided|95.0|-1.1|3.6||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742301|NCT00428090|3204661|Superiority or Other||Mean Difference (Final Values)|0.5||||0.649|2-Sided|95.0|-1.5|2.4||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742302|NCT00428090|3204661|Superiority or Other||Mean Difference (Final Values)|0.1||||0.919|2-Sided|95.0|-2.1|2.3||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742303|NCT00428090|3204662|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.213|2-Sided|95.0|-4.8|1.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742357|NCT00427934|3204715|Superiority or Other||Mean Difference (Final Values)|0.01||||0.968||90.0|-0.37|0.39||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 4|
1742304|NCT00428090|3204662|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.942|2-Sided|95.0|-2.9|2.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742305|NCT00428090|3204662|Superiority or Other||Mean Difference (Final Values)|0.3||||0.797|2-Sided|95.0|-2.1|2.7||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742306|NCT00428090|3204662|Superiority or Other||Mean Difference (Final Values)|0.5||||0.639||95.0|-1.7|2.8||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742307|NCT00428090|3204662|Superiority or Other||Mean Difference (Final Values)|0.0||||0.998|2-Sided|95.0|-2.1|2.1||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742308|NCT00428090|3204662|Superiority or Other||Mean Difference (Final Values)|0.0||||0.958|2-Sided|95.0|-1.7|1.8||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742309|NCT00428090|3204662|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.798|2-Sided|95.0|-2.2|1.7||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742310|NCT00428090|3204662|Superiority or Other||Mean Difference (Final Values)|0.4||||0.693|2-Sided|95.0|-1.4|2.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742311|NCT00428090|3204662|Superiority or Other||Mean Difference (Final Values)|0.0||||0.957|2-Sided|95.0|-1.6|1.5||Comparison between Placebo and RSG XR 2mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742312|NCT00428090|3204663|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.009|2-Sided|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742313|NCT00428090|3204663|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.307|2-Sided|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742314|NCT00428090|3204663|Superiority or Other||Mean Difference (Final Values)|0.0||||0.939|2-Sided|95.0|-0.2|0.3||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742315|NCT00428090|3204663|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.006|2-Sided|95.0|-0.7|-0.1||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742316|NCT00428090|3204663|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.38|2-Sided|95.0|-0.3|0.1||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742317|NCT00428090|3204663|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.102|2-Sided|95.0|-0.4|0.0||Comparison between Placebo and RSG XR 2 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742318|NCT00428090|3204663|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.085|2-Sided|95.0|-0.5|0.0||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742358|NCT00427934|3204715|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.703||90.0|-0.41|0.26||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 2|
1742906|NCT00420927|3205873|Superiority or Other||||||<|0.001|||||||ANCOVA|Analysis of covariance adjusting for baseline|||
1742319|NCT00428090|3204663|Superiority or Other||Mean Difference (Final Values)|0.0||||0.958|2-Sided|95.0|-0.2|0.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742320|NCT00428090|3204663|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.133|2-Sided|95.0|-0.3|0.0||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742321|NCT00428090|3204664|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.131|2-Sided|95.0|-3.1|0.4||Comparison between Placebo and Donepezil 10 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742322|NCT00428090|3204664|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.297|2-Sided|95.0|-2.2|0.7||Comparison between Placebo and RSG XR 8 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742323|NCT00428090|3204664|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.272|2-Sided|95.0|-2.2|0.6||Comparison between Placebo and RSG XR 2 mg at Week 24 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742324|NCT00428090|3204664|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.073|2-Sided|95.0|-3.4|0.2||Comparison between Placebo and Donepezil 10 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742325|NCT00428090|3204664|Superiority or Other||Mean Difference (Final Values)|0.8||||0.165|2-Sided|95.0|-0.3|2.0||Comparison between Placebo and RSG XR 8 mg at Week 16 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742326|NCT00428090|3204664|Superiority or Other||Mean Difference (Final Values)|0.1||||0.839|2-Sided|95.0|-1.1|1.3||Comparison between Placebo and RSG XR 2 mg in at Week 16 Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742327|NCT00428090|3204664|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.318|2-Sided|95.0|-2.1|0.7||Comparison between Placebo and Donepezil 10 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742328|NCT00428090|3204664|Superiority or Other||Mean Difference (Final Values)|0.1||||0.816|2-Sided|95.0|-0.9|1.2||Comparison between Placebo and RSG XR 8 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742329|NCT00428090|3204664|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.116|2-Sided|95.0|-2.0|0.2||Comparison between Placebo and RSG XR 2 mg at Week 8 in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742330|NCT00428090|3204665|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.009|2-Sided|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742331|NCT00428090|3204665|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.307|2-Sided|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742332|NCT00428090|3204665|Superiority or Other||Mean Difference (Final Values)|0.0||||0.939|2-Sided|95.0|-0.2|0.3||Comparison between Placebo and RSG XR 2 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742333|NCT00428090|3204666|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.025|2-Sided|95.0|-0.8|-0.1||Comparison between Placebo and Donepezil 10 mg in All except e4/e4’s cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742334|NCT00428090|3204666|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.276|2-Sided|95.0|-0.4|0.1||Comparison between Placebo and RSG XR 8 mg in All except e4/e4’s cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742336|NCT00428090|3204667|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.414|2-Sided|95.0|-0.7|0.3||Comparison between Placebo and Donepezil 10 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix||
1742337|NCT00428090|3204667|Superiority or Other||Mean Difference (Final Values)|0.0||||0.891|2-Sided|95.0|-0.4|0.3||Comparison between Placebo and RSG XR 8 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742338|NCT00428090|3204667|Superiority or Other||Mean Difference (Final Values)|0.1||||0.663|2-Sided|95.0|-0.3|0.4||Comparison between Placebo and RSG XR 2 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742339|NCT00428090|3204668|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.131|2-Sided|95.0|-3.1|0.4||Comparison between Placebo and Donepezil 10 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|||
1742340|NCT00428090|3204668|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.297|2-Sided|95.0|-2.2|0.7||Comparison between Placebo and RSG XR 8 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742341|NCT00428090|3204668|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.272|2-Sided|95.0|-2.2|0.6||Comparison between Placebo and RSG XR 2 mg in Full population cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742342|NCT00428090|3204669|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.105|2-Sided|95.0|-3.5|0.3||Comparison between Placebo and Donepezil 10 mg in All except e4/e4’s cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742343|NCT00428090|3204669|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.315|2-Sided|95.0|-2.4|0.8||Comparison between Placebo and RSG XR 8 mg in All except e4/e4’s cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742344|NCT00428090|3204669|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.131|2-Sided|95.0|-2.7|0.4||Comparison between Placebo and RSG XR 2 mg in All except e4/e4’s cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742345|NCT00428090|3204670|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.602|2-Sided|95.0|-3.5|2.1||Comparison between Placebo and Donepezil 10mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742346|NCT00428090|3204670|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.338|2-Sided|95.0|-3.0|1.0||Comparison between Placebo and RSG XR 8 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742347|NCT00428090|3204670|Superiority or Other||Mean Difference (Final Values)|-1.8||||0.074|2-Sided|95.0|-3.8|0.2||Comparison between Placebo and RSG XR 2 mg in APOE e4 neg cohort|Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of par. with evaluable data||
1742348|NCT00427934|3204704|Superiority or Other|||||||0.9826|||||||Log Rank||||
1742349|NCT00427934|3204705|Superiority or Other|||||||0.649|||||||Fisher Exact||||
1742350|NCT00427934|3204706|Superiority or Other||Mean Difference (Final Values)|0.56||||0.818||90.0|-3.5|4.62||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12|
1742351|NCT00427934|3204706|Superiority or Other||Mean Difference (Final Values)|0.7||||0.734||90.0|-2.71|4.11||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4|
1742352|NCT00427934|3204707|Superiority or Other||Mean Difference (Final Values)|-1.68||||0.344||90.0|-4.62|1.26||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12|
1742353|NCT00427934|3204707|Superiority or Other||Mean Difference (Final Values)|0.57||||0.698||90.0|-1.87|3.01||This analysis was carried out ANCOVA with baseline SF-36 score as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4|
1742354|NCT00427934|3204713|Superiority or Other||Percentage Difference|9.09||||0.155||90.0|-6.16|21.83||p-value (one-sided) was based on Barnard exact test if more than 20% of expected cell counts were < 5 otherwise Pearson chi-square test.|Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.||
1742355|NCT00427934|3204715|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.696||90.0|-0.53|0.33||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 12|
1742359|NCT00427934|3204715|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.653||90.0|-0.31|0.18||This analysis was carried out using ANCOVA with baseline DAS28-4 (CRP) as the covariate, treatment, country as fixed effects.|ANCOVA|||Week 1|
1742360|NCT00427934|3204716|Superiority or Other||Mean Difference (Final Values)|0.41||||0.912||90.0|-5.81|6.64||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12|
1742361|NCT00427934|3204716|Superiority or Other||Mean Difference (Final Values)|3.48||||0.32||90.0|-2.29|9.25||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8|
1742362|NCT00427934|3204716|Superiority or Other||Mean Difference (Final Values)|4.65||||0.233||90.0|-1.79|11.1||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4|
1742363|NCT00427934|3204716|Superiority or Other||Mean Difference (Final Values)|1.33||||0.698||90.0|-4.34|6.99||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2|
1742364|NCT00427934|3204716|Superiority or Other||Mean Difference (Final Values)|-2.2||||0.481||90.0|-7.36|2.96||This analysis was carried out using ANCOVA with CRP as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1|
1742365|NCT00427934|3204717|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.396||90.0|-0.36|0.12||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12|
1742366|NCT00427934|3204717|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.063||90.0|-0.41|-0.03||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8|
1742367|NCT00427934|3204717|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.532||90.0|-0.23|0.11||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4|
1742368|NCT00427934|3204717|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.068||90.0|-0.35|-0.02||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2|
1742369|NCT00427934|3204717|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.464||90.0|-0.19|0.07||This analysis was carried out using ANCOVA with HAQ-DI as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1|
1742370|NCT00427934|3204718|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.49||90.0|-0.42|0.17||This analysis was carried out using ANCOVA with baseline Physician’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12|
1742371|NCT00427934|3204718|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.112||90.0|-0.52|0.01||This analysis was carried out using ANCOVA with baseline Physician’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8|
1742372|NCT00427934|3204718|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.767||90.0|-0.31|0.21||This analysis was carried out using ANCOVA with baseline Physician’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4|
1742373|NCT00427934|3204718|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.757||90.0|-0.28|0.19||This analysis was carried out using ANCOVA with baseline Physician’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2|
1742374|NCT00427934|3204718|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.54||90.0|-0.28|0.13||This analysis was carried out using ANCOVA with baseline Physician’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1|
1742375|NCT00427934|3204719|Superiority or Other||Mean Difference (Final Values)|-1.78||||0.712||90.0|-9.73|6.18||This analysis was carried out using ANCOVA with baseline Patient’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12|
1742376|NCT00427934|3204719|Superiority or Other||Mean Difference (Final Values)|-7.68||||0.118||90.0|-15.76|0.4||This analysis was carried out using ANCOVA with baseline Patient’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8|
1742377|NCT00427934|3204719|Superiority or Other||Mean Difference (Final Values)|-0.98||||0.83||90.0|-8.55|6.58||This analysis was carried out using ANCOVA with baseline Patient’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4|
1742378|NCT00427934|3204719|Superiority or Other||Mean Difference (Final Values)|-3.96||||0.338||90.0|-10.8|2.87||This analysis was carried out using ANCOVA with baseline Patient’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2|
1742379|NCT00427934|3204719|Superiority or Other||Mean Difference (Final Values)|-2.36||||0.524||90.0|-8.49|3.77||This analysis was carried out using ANCOVA with baseline Patient’s Global Assessment of Arthritis as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1|
1742380|NCT00427934|3204720|Superiority or Other||Mean Difference (Final Values)|-2.22||||0.644||90.0|-10.14|5.71||This analysis was carried out using ANCOVA with baseline patient’s assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12|
1742381|NCT00427934|3204720|Superiority or Other||Mean Difference (Final Values)|-1.63||||0.745||90.0|-9.91|6.65||This analysis was carried out using ANCOVA with baseline patient’s assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8|
1742382|NCT00427934|3204720|Superiority or Other||Mean Difference (Final Values)|0.73||||0.872||90.0|-6.79|8.25||This analysis was carried out using ANCOVA with baseline patient’s assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4|
1742383|NCT00427934|3204720|Superiority or Other||Mean Difference (Final Values)|-5.26||||0.239||90.0|-12.62|2.11||This analysis was carried out using ANCOVA with baseline patient’s assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2|
1742384|NCT00427934|3204720|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.925||90.0|-6.41|5.72||This analysis was carried out using ANCOVA with baseline patient’s assessment of arthritis pain as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1|
1742613|NCT00424762|3205165|Superiority or Other|||||||0.26|||||||t-test, 2 sided|||powered to detect difference of at least 10% between groups|
1742385|NCT00427934|3204721|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.966||90.0|-1.91|1.81||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12|
1742386|NCT00427934|3204721|Superiority or Other||Mean Difference (Final Values)|-1.45||||0.167||90.0|-3.17|0.28||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8|
1742387|NCT00427934|3204721|Superiority or Other||Mean Difference (Final Values)|0.15||||0.867||90.0|-1.35|1.66||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4|
1742388|NCT00427934|3204721|Superiority or Other||Mean Difference (Final Values)|0.26||||0.799||90.0|-1.45|1.97||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2|
1742389|NCT00427934|3204721|Superiority or Other||Mean Difference (Final Values)|-0.32||||0.7||90.0|-1.7|1.06||This analysis was carried out using ANCOVA baseline swollen joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1|
1742390|NCT00427934|3204722|Superiority or Other||Mean Difference (Final Values)|-1.48||||0.294||90.0|-3.82|0.85||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 12|
1742391|NCT00427934|3204722|Superiority or Other||Mean Difference (Final Values)|-1.61||||0.263||90.0|-3.98|0.76||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 8|
1742392|NCT00427934|3204722|Superiority or Other||Median Difference (Final Values)|0.01||||0.996||90.0|-2.35|2.36||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 4|
1742393|NCT00427934|3204722|Superiority or Other||Mean Difference (Final Values)|0.3||||0.816||90.0|-1.82|2.41||This analysis was carried out using ANCOVA with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 2|
1742394|NCT00427934|3204722|Superiority or Other||Mean Difference (Final Values)|1.1||||0.335||90.0|-0.79|2.99||This analysis was carried out using analysis of covariance (ANCOVA) with baseline tender/painful joint count as the covariate, treatment, region as fixed effects.|ANCOVA|||Week 1|
1742395|NCT00427934|3204723|Superiority or Other||Percentage Difference|-3.03||||1||90.0|-13.59|1.28|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 12|
1742396|NCT00427934|3204723|Superiority or Other||Percentage Difference|2.6||||0.258||90.0|-5.08|7.95|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8|
1742397|NCT00427934|3204723|Superiority or Other||Percentage Difference|-3.03||||1||90.0|-13.59|1.28|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4|
1742398|NCT00427934|3204724|Superiority or Other||Percentage Difference|1.3||||0.489||90.0|-11.24|10.96|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 12|
1742399|NCT00427934|3204724|Superiority or Other||Percentage Difference|-1.3||||0.899||90.0|-13.56|7.92|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8|
1742400|NCT00427934|3204724|Superiority or Other||Percentage Difference|-3.46||||1||90.0|-14.39|3.42|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4|
1742401|NCT00427934|3204724|Superiority or Other||Percentage Difference|2.6||||0.258||90.0|-5.08|7.95|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 2|
1742402|NCT00427934|3204724|Superiority or Other||Percentage Difference|1.3||||0.42||90.0|-6.34|6.01|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 1|
1742403|NCT00427934|3204725|Superiority or Other||Percentage Difference|8.66||||0.175||90.0|-7.07|22.03|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 8|
1742404|NCT00427934|3204725|Superiority or Other||Percentage Difference|3.03||||0.37||90.0|-12.85|16.77|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 4|
1742405|NCT00427934|3204725|Superiority or Other||Percentage Difference|0.43||||0.477||90.0|-13.67|11.64|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 2|
1742406|NCT00427934|3204725|Superiority or Other||Percentage Difference|-1.73||||0.79||90.0|-15.13|8.68|||Barnard/Pearson chi-square test||Percentage Difference = maraviroc responders divided by the number of maraviroc participants analyzed minus placebo responders divided by the number of placebo participants analyzed.|Week 1|
1742420|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.99|||||2-Sided|95.0|1.45|2.74||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742907|NCT00420927|3205873|Superiority or Other||||||<|0.037|||||||ANCOVA|Analysis of covariance adjusting for baseline|||
1742407|NCT00427908|3204819|Non-Inferiority|Criterion indicative of non-inferiority (serogroup C only): one month after vaccination, the lower limit of the 2-sided standardized asymptotic 95% CI for the group difference (Nimenrix Group minus Meningitec Group) in the percentage of subjects with rSBA titer ≥ 1:8 is greater than or equal to the predefined clinical limit of -15%.|Difference in vaccine response rate|1.47|||||2-Sided|95.0|-0.27|7.89||||||To evaluate the non-inferiority of the vaccine response induced by Nimenrix™ conjugate vaccine when compared to the licensed Meningitec™ vaccine for MenC as measured by rSBA.|
1742408|NCT00427908|3204822|Non-Inferiority|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrux minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenY.|Difference in percentage|16.23|||||2-Sided|95.0|8.99|26.78||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenY. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenY titer from pre to post vaccination.|
1742409|NCT00427908|3204822|Non-Inferiority|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenW-135.|Difference in percentage|4.41|||||2-Sided|95.0|1.51|12.21||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenW-135. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenW-135 titer from pre to post vaccination.|
1742410|NCT00427908|3204822|Non-Inferiority|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response is greater than or equal to -15% for rSBA-MenC.|Difference in percentage|13.18|||||2-Sided|95.0|4.79|24.32||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenC. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenC titer from pre to post vaccination.|
1742411|NCT00427908|3204822|Non-Inferiority|Criterion indicative of non-inferiority: lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (Nimenrix minus Mencevax) in the percentage of subjects with bactericidal vaccine response to be greater than or equal to -15% for rSBA-MenA.|Difference in percentage|6.44|||||2-Sided|95.0|1.15|16.04||||||To evaluate the non-inferiority of Nimenrix™ conjugate vaccine compared to Mencevax™ plain polysaccharide vaccine in terms of the vaccine response (VRR) to MenA. Response to a vaccine antigen component was defined as: For initially seronegative subject, post-vaccination serum bactericidal assay using rabbit complement (rSBA) titer ≥ 1:32. For initially seropositive subject, at least 4-fold increase in rSBA-MenA titer from pre to post vaccination.|
1742412|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.0|||||2-Sided|95.0|1.41|2.83||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742413|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|3.35|||||2-Sided|95.0|2.19|5.12||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742414|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.48|||||2-Sided|95.0|1.08|2.03||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742415|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.36|||||2-Sided|95.0|0.94|1.97||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742416|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.96|||||2-Sided|95.0|1.32|2.91||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742417|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.96|||||2-Sided|95.0|1.46|2.62||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742418|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.85|||||2-Sided|95.0|1.32|2.58||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742419|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.04|||||2-Sided|95.0|1.5|2.76||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742608|NCT00425061|3205149|Superiority or Other||LS mean difference|-0.1||||0.323|2-Sided|95.0|-0.2|0.1|||ANCOVA|||Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.|
1742421|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.47|||||2-Sided|95.0|1.71|3.55||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742422|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.42|||||2-Sided|95.0|1.06|1.91||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742423|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.18|||||2-Sided|95.0|1.53|3.12||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742424|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.45|||||2-Sided|95.0|0.95|2.24||||||Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742425|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.79||||||95.0|1.07|3.0||||||Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742426|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.15|||||2-Sided|95.0|0.8|1.66||||||Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742427|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.04|||||2-Sided|95.0|0.68|1.59||||||Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742428|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.33|||||2-Sided|95.0|0.8|2.23||||||Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742429|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.34|||||2-Sided|95.0|0.94|1.92||||||Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742430|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.03|||||2-Sided|95.0|0.67|1.59||||||Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742431|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.47|||||2-Sided|95.0|1.01|2.16||||||Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742432|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.4|||||2-Sided|95.0|0.92|2.12||||||Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742433|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.32|||||2-Sided|95.0|1.47|3.64||||||Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742434|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|1.37|||||2-Sided|95.0|0.95|1.99||||||Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742435|NCT00427895|3204827|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMC Ratio|2.31|||||2-Sided|95.0|1.52|3.51||||||Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742436|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|10.5|||||2-Sided|95.0|6.8|14.7||||||Serotype 23F: Difference (cohort 3 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742437|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|8.4|||||2-Sided|95.0|5.4|12.0||||||Serotype 19F: Difference (cohort 3 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742438|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|1.4|||||2-Sided|95.0|0.3|3.1||||||Serotype 19A: Difference (cohort 3 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742609|NCT00425061|3205149|Superiority or Other||LS mean difference|0.0||||0.492|2-Sided|95.0|-0.2|0.1|||ANCOVA|||Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.|
1742439|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.1|||||2-Sided|95.0|0.9|5.7||||||Serotype 18C: Difference (cohort 3 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742440|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|11.2|||||2-Sided|95.0|8.0|14.9||||||Serotype 14: Difference (cohort 3 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742441|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.8|||||2-Sided|95.0|4.8|11.4||||||Serotype 9V: Difference (cohort 3 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742442|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|8.2|||||2-Sided|95.0|5.4|11.6||||||Serotype 7F: Difference (cohort 3 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742443|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.4|||||2-Sided|95.0|4.1|9.3||||||Serotype 6B: Difference (cohort 3 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742444|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.7|||||2-Sided|95.0|1.7|6.1||||||Serotype 6A: Difference (cohort 3 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742445|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|5.1|||||2-Sided|95.0|1.4|9.1||||||Serotype 5: Difference (cohort 3 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742446|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.2|||||2-Sided|95.0|2.1|6.9||||||Serotype 4: Difference (cohort 3 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742447|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.6|||||2-Sided|95.0|-0.3|5.9||||||Serotype 3: Difference (cohort 3 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742448|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.2|||||2-Sided|95.0|4.3|10.6||||||Serotype 1: Difference (cohort 3 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742449|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|0.5|||||2-Sided|95.0|-4.7|5.7||||||Serotype 23F: Difference (cohort 2 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742450|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|1.9|||||2-Sided|95.0|-2.4|6.2||||||Serotype 19F: Difference (cohort 2 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742451|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.1|||||2-Sided|95.0|-2.1|1.9||||||Serotype 19A: Difference (cohort 2 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742452|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.6|||||2-Sided|95.0|-3.8|2.5||||||Serotype 18C: Difference (cohort 2 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742453|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Perecentage|4.2|||||2-Sided|95.0|-0.1|8.7||||||Serotype 14: Difference (cohort 2 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742454|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.8|||||2-Sided|95.0|-0.3|7.9||||||Serotype 9V: Difference (cohort 2 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742455|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.4|||||2-Sided|95.0|0.6|8.2||||||Serotype 7F: Difference (cohort 2 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742456|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.0|||||2-Sided|95.0|0.8|7.2||||||Serotype 6B: Difference (cohort 2 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742457|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.2|||||2-Sided|95.0|-0.4|4.8||||||Serotype 6A: Difference (cohort 2 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742458|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.9|||||2-Sided|95.0|-5.8|3.9||||||Serotype 5: Difference (cohort 2 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742610|NCT00425061|3205149|Superiority or Other||LS mean Difference|0.0||||0.482|2-Sided|95.0|-0.2|0.1|||ANCOVA|||Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.|
1742459|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.4|||||2-Sided|95.0|-0.4|5.5||||||Serotype 4: Difference (cohort 2 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742460|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|0.2|||||2-Sided|95.0|-3.6|4.1||||||Serotype 3: Difference (cohort 2 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742461|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.6|||||2-Sided|95.0|-0.2|7.5||||||Serotype 1: Difference (cohort 2 – cohort 1) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742462|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|23.2|||||2-Sided|95.0|17.0|29.3||||||Serotype 23F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742463|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|Difference in Percentage|-1.2|||||2-Sided|95.0|-5.5|3.2||||||Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|
1742464|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|4.1|||||2-Sided|95.0|1.2|7.1||||||Serotype 19A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742465|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.5|||||2-Sided|95.0|2.6|10.5||||||Serotype 18C: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742466|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|-0.9|||||2-Sided|95.0|-5.6|3.8||||||Serotype 14: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742467|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|14.1|||||2-Sided|95.0|8.7|19.5||||||Serotype 9V: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742468|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|12.3|||||2-Sided|95.0|7.3|17.4||||||Serotype 7F: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742469|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|7.5|||||2-Sided|95.0|3.2|12.0||||||Serotype 6B: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742470|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|26.6|||||2-Sided|95.0|21.7|31.7||||||Serotype 6A: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742471|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|2.3|||||2-Sided|95.0|-2.6|7.2||||||Serotype 5: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742472|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.4|||||2-Sided|95.0|-0.2|7.2||||||Serotype 4: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742473|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|3.9|||||2-Sided|95.0|-0.3|8.1||||||Serotype 3: Difference (13vPnC - 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742474|NCT00427895|3204829|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than -0.10.|Difference in Percentage|6.5|||||2-Sided|95.0|1.9|11.2||||||Serotype 1: Difference (13vPnC – 23vPS) in proportions, expressed as a percentage presented along with exact 2-sided 95%CI.|
1742475|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.5|||||2-Sided|95.0|3.2|9.41||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742476|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.4|||||2-Sided|95.0|2.97|6.58||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742477|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.7|||||2-Sided|95.0|1.87|3.76||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742478|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.1|||||2-Sided|95.0|2.02|4.78||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742614|NCT00424762|3205166|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||powered to detect at least 33% difference between groups|
1742479|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||2-Sided|95.0|1.3|2.84||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742480|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.8|||||2-Sided|95.0|3.13|10.82||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742481|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.8|||||2-Sided|95.0|2.41|6.03||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742482|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||2-Sided|95.0|1.83|4.63||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742483|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|6.5|||||2-Sided|95.0|4.09|10.19||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742484|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT ratio|2.6|||||2-Sided|95.0|1.72|3.8||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742485|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.1|||||2-Sided|95.0|2.26|4.3||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742486|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.2|||||2-Sided|95.0|2.87|6.08||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS/23vPS).|
1742487|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.5|||||2-Sided|95.0|1.99|6.13||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742488|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.7|||||2-Sided|95.0|1.77|4.01||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742489|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.6|||||2-Sided|95.0|1.78|3.68||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742490|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.2|||||2-Sided|95.0|1.37|3.5||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742491|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5|||||2-Sided|95.0|0.99|2.39||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742492|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||2-Sided|95.0|0.93|2.97||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742493|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.7|||||2-Sided|95.0|2.76|7.99||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742494|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||2-Sided|95.0|1.5|4.0||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742495|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.2|||||2-Sided|95.0|2.04|4.97||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742496|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||2-Sided|95.0|0.88|1.98||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742497|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||2-Sided|95.0|1.13|2.16||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742498|NCT00427895|3204830|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.4|||||2-Sided|95.0|2.32|5.09||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/23vPS - 23vPS).|
1742499|NCT00427895|3204831|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|Difference in Percentage|39.2|||||2-Sided|95.0|33.0|45.1|||||||
1742500|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.2|||||2-Sided|95.0|3.31|5.31||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.|
1742501|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|3.0|||||2-Sided|95.0|2.44|3.6||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.|
1742502|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||2-Sided|95.0|2.02|2.66||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.|
1742503|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||2-Sided|95.0|1.91|2.79||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.|
1742504|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.9|||||2-Sided|95.0|4.01|5.93||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.|
1742505|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||2-Sided|95.0|2.34|3.52||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.|
1742506|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||2-Sided|95.0|2.41|3.49||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.|
1742507|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|4.9|||||2-Sided|95.0|4.13|5.93||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.|
1742508|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.2|||||2-Sided|95.0|1.84|2.67||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.|
1742509|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||2-Sided|95.0|1.55|2.42||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.|
1742510|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.3|||||2-Sided|95.0|1.92|2.76||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.|
1742511|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||2-Sided|95.0|0.84|1.13||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.|
1742512|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.4|||||2-Sided|95.0|2.03|2.87||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 3.|
1742513|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.3|||||2-Sided|95.0|0.94|1.84||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.|
1742615|NCT00424593|3205197|Superiority or Other|||||||0.008||||||P-value for Week 13 Change from Baseline.|ANOVA||||
1742616|NCT00424593|3205198|Superiority or Other|||||||0.093||||||P-value for DBP Week 13 Change from Baseline.|ANOVA||||
1742514|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||2-Sided|95.0|0.87|1.54||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.|
1742515|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||2-Sided|95.0|1.16|1.69||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.|
1742516|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||2-Sided|95.0|0.86|1.47||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.|
1742517|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||2-Sided|95.0|1.16|2.12||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.|
1742518|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.5||||||95.0|1.11|1.98||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.|
1742519|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||2-Sided|95.0|1.03|1.79||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.|
1742520|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||2-Sided|95.0|1.24|2.12||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.|
1742521|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.7|||||2-Sided|95.0|1.3|2.15||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.|
1742522|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4||||||95.0|1.01|1.8||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.|
1742523|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||2-Sided|95.0|1.07|1.77||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.|
1742524|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||2-Sided|95.0|0.81|1.19||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.|
1742525|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||2-Sided|95.0|1.08|1.73||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures in 13vPnC participants between Cohort 1 and Cohort 2.|
1742526|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|5.2|||||2-Sided|95.0|3.67|7.33||||||Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1742527|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.0|||||2-Sided|95.0|0.72|1.28||||||Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1742528|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||2-Sided|95.0|1.56|2.41||||||Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1742529|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.9|||||2-Sided|95.0|1.39|2.51||||||Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1742530|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|0.9|||||2-Sided|95.0|0.64|1.21||||||Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1742617|NCT00424593|3205198|Superiority or Other|||||||0.764||||||P-value for SBP Week 13 Change from Baseline.|ANOVA||||
1742531|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.9|||||2-Sided|95.0|2.0|4.08||||||Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1742532|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.8|||||2-Sided|95.0|1.98|3.87||||||Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1742533|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|2.5|||||2-Sided|95.0|1.82|3.48||||||Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1742534|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|12.1|||||2-Sided|95.0|8.63|17.08||||||Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1742535|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.2|||||2-Sided|95.0|0.93|1.62||||||Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1742536|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.6|||||2-Sided|95.0|1.19|2.13||||||Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1742537|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.1|||||2-Sided|95.0|0.9|1.32||||||Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC - 23vPS).|
1742538|NCT00427895|3204832|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 2-sided 95% CI was greater than 0.5.|GMT Ratio|1.4|||||2-Sided|95.0|1.1|1.78||||||Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC – 23vPS).|
1742539|NCT00427700|3204846|Superiority or Other||Mean Difference (Final Values)|13.0||||0.2|2-Sided|95.0|0.0|34.0|||t-test, 2 sided|||Null hypothesis: There is no difference between the mean values of progesterone between both groups.|
1742540|NCT00427700|3204847|Superiority or Other||Mean Difference (Final Values)|12.0||||0.3|2-Sided|95.0|-9.0|33.0|||Fisher Exact|||The null hypothesis is that there is no significant difference between two drugs for ovulation induction.A sample size of 40 women per arm was calculated for this superiority trial, considering an alpha and beta error of 0.05 and 0.2, respectively, to find an absolute difference of 30% in the ovulation rate between groups, based on a previous study published by Mitwally and Casper (18) where the ovulation rate with CC was approximately 45%.|
1742541|NCT00427648|3204851|Superiority|||||||0.366|||||||Kruskal-Wallis||||
1742542|NCT00427648|3204852|Superiority|||||||0.802|||||||Kruskal-Wallis||||
1742543|NCT00427648|3204853|Superiority|||||||0.342|||||||Kruskal-Wallis||||
1742544|NCT00427648|3204854|Superiority|||||||0.189|||||||Kruskal-Wallis||||
1742545|NCT00427648|3204855|Superiority|||||||0.441|||||||Kruskal-Wallis||||
1742546|NCT00427648|3204856|Superiority|||||||0.617|||||||Kruskal-Wallis||||
1742547|NCT00427648|3204857|Superiority|||||||0.588|||||||Kruskal-Wallis|||null hypothesis - no difference in average number of voids between the 2 groups, power calculation estimated 40 participants needed per arm to show a 2 void difference between lidocaine and saline placebo.|
1742548|NCT00427349|3204873|Superiority or Other||||||<|0.001|||||||one sample binomial test|The study result was compared to a null hypothesis of 20% 4-month progression free survival rate using one sample binomial test||The null hypothesis is that the 4-month progression free survival rate is 20%. Alternatively, AMG 706 will be considered worthy of further study if its true progression-free survival rate is 40% or better at 4 months (alternative hypothesis).|
1742549|NCT00427193|3204879|Other||Mean Difference (Net)|-5.9|Standard Error of the Mean|0.26|<|0.0001|2-Sided|95.0|-6.4|-5.3|||Mixed Models Analysis|||Comparison of change in FM in 2 groups over at 24 mos, controlling for site, sex, BMI group, and baseline FM. A repeated measures Mixed Model was employed for the analysis. For any outcome, Type I error was controlled using a hierarchical gatekeeping strategy testing, first, the GroupXTime interaction, and, if non-significant, the main effects of these two factors. Bonferroni corrections were employed for non-significant effects. All tests were at p<0.05|
1742550|NCT00427193|3204880|Other||Mean Difference (Net)|-5.9|Standard Error of the Mean|0.31|<|0.001|2-Sided|95.0|-6.5|-5.3|||Mixed Models Analysis|||Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) and Fat Free Mass (FFM) were determined for the whole body.|
1742551|NCT00427193|3204881|Other||Mean Difference (Net)|0.04|Standard Error of the Mean|0.1||0.82|2-Sided|95.0|-0.16|0.23|||Mixed Models Analysis||||
1742552|NCT00427193|3204882|Other||Mean Difference (Final Values)|-64.0|Standard Deviation|13.5|<|0.0001|2-Sided|95.0|-90.5|-37.5|||Mixed Models Analysis||||
1742553|NCT00427193|3204883|Other||Mean Difference (Net)|-82.0|Standard Error of the Mean|11.12|<|0.001|2-Sided|95.0|-103.8|-60.2|||Mixed Models Analysis||||
1742554|NCT00427193|3204884|Other||Mean Difference (Net)|0.03|Standard Error of the Mean|0.02||0.84|2-Sided|95.0|-0.0092|0.069|||Mixed Models Analysis||||
1742618|NCT00424593|3205199|Superiority or Other|||||||0.028||||||P-value for Week 13 Change from Baseline.|ANOVA||||
1742619|NCT00424593|3205200|Superiority or Other|||||||0.008||||||P-value for Change from Baseline.|ANOVA|ANOVA based on rank transformation.|||
1742555|NCT00427193|3204885|Other||difference in mean change|0.02|Standard Deviation|0.02||0.7|2-Sided|95.0|-0.019|0.059||Type I error was controlled using a hierarchical gatekeeping strategy.|Mixed Models Analysis|||All analysis under intention-to-treat. All observations were included The primary analytic was a repeated measures analysis. The dependent variable was the change from baseline 12 & 14mos., with treatment, time, and the treatment × time interaction as independent variables. Site, sex, BMI stratum, and the baseline value of the outcome were included as covariates. The predicted mean changes ± standard errors are the adjusted values from the contrasts of the multiple timepoints.|
1742556|NCT00426751|3204919|Non-Inferiority or Equivalence|For the assessment of differences between both treatment groups a generalised model (under binomial probability distribution), adjusted for centre, was applied.|Mean Difference (Final Values)|6.8||||||95.0|-3.0|16.6|||||Analysis based on the ITT population confirmed the results observed in the PP population.||
1742557|NCT00426751|3204920|Non-Inferiority or Equivalence|For the assessment of differences between both treatment groups, a generalized model (under binomial probability distribution), adjusted for center, was applied.|Median Difference (Final Values)|2.1||||||90.0|-8.5|12.8|||||||
1742558|NCT00426660|3204925|Superiority or Other||25th percentile (median)|58.0|||||2-Sided|95.0|57.0|62.0|||||||
1742559|NCT00426660|3204925|Superiority or Other||50th percentile (median)|86.5|||||2-Sided|95.0|82.0|92.0|||||||
1742560|NCT00426660|3204925|Superiority or Other||75th percentile (median)|169.0|||||2-Sided|95.0|135.0|178.0|||||||
1742561|NCT00426153|3204978|Superiority or Other|||||||0.98||||||P Values < 0.05 were considered statistically significant|Rank sum||||
1742562|NCT00426153|3204979|Superiority or Other|||||||0.045||||||P values < 0.05 were considered statistically significant|Rank sum||||
1742563|NCT00426153|3204980|Superiority or Other|||||||0.048|||||||Rank-sum test|||P values <0.05 were considered statistically significant.|
1742564|NCT00425945|3204984|Superiority or Other||Mean Difference (Net)|-1.3|||||2-Sided|95.0|-3.4|0.8|||||||
1742565|NCT00425945|3204985|Superiority or Other||Mean Difference (Net)|3.8|||||2-Sided|95.0|-1.6|9.3|||||||
1742566|NCT00425945|3204986|Superiority or Other||Mean Difference (Net)|0.0|||||2-Sided|95.0|-0.1|0.1|||||||
1742567|NCT00425945|3204987|Superiority or Other||Mean Difference (Net)|0.8|||||2-Sided|95.0|-0.9|2.5|||||||
1742568|NCT00425945|3204988|Superiority or Other||Mean Difference (Net)|-1.0|||||2-Sided|95.0|-4.4|2.3|||||||
1742569|NCT00425945|3204989|Superiority or Other||Mean Difference (Net)|1.2|||||2-Sided|95.0|0.1|2.4|||||||
1742570|NCT00425945|3204990|Superiority or Other||Mean Difference (Net)|0.2|||||2-Sided|95.0|0.0|0.4|||||||
1742571|NCT00425945|3204991|Superiority or Other||Mean Difference (Net)|-0.5|||||2-Sided|95.0|-1.5|0.5|||||||
1742572|NCT00425945|3204992|Superiority or Other||Mean Difference (Net)|-3.2|||||2-Sided|95.0|-6.8|0.5|||||||
1742573|NCT00425945|3204993|Superiority or Other||Mean Difference (Net)|0.0|||||2-Sided|95.0|0.0|0.1|||||||
1742574|NCT00425945|3204994|Superiority or Other||Mean Difference (Net)|0.1|||||2-Sided|95.0|-0.1|0.3|||||||
1742575|NCT00425945|3204995|Superiority or Other||Mean Difference (Net)|18.2|||||2-Sided|95.0|-2.3|38.7|||||||
1742576|NCT00425945|3204996|Superiority or Other||Mean Difference (Net)|0.4|||||2-Sided|95.0|-1.7|2.5|||||||
1742577|NCT00425945|3204997|Superiority or Other||Mean Difference (Net)|4.4|||||2-Sided|95.0|-2.1|10.8|||||||
1742578|NCT00425945|3204998|Superiority or Other||Mean Difference (Net)|7.3|||||2-Sided|95.0|-0.1|14.9|||||||
1742579|NCT00425854|3205004|Superiority or Other||Clinical benefit rate|0.1|||||2-Sided|95.0|0.02|0.27|||||Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort A. The confidence interval (CI) is an exact Clopper Pearson CI.||
1742580|NCT00425854|3205009|Superiority or Other||Maximum Likelihood|0.048|||||2-Sided|95.0|0.001|0.238|||||Maximum Likelihood estimates. The clinical benefit rate for Cohort A was calculated by relating the number of patients with CB to all treated patients in Cohort B. The CI is an exact Clopper Pearson CI.||
1742581|NCT00425698|3205023|Superiority or Other||Mean Difference (Final Values)|4.0|Standard Deviation|15.0|<|0.05|2-Sided|95.0|||||t-test, 2 sided|||Null hypothesis: Erythopoietin significantly improves kidney graft function. Power calculation: with a difference of at least 4 mL/min in mean eGFR between groups the number of patients enrolled per group (at least 41) would allowed the detection of a significant difference between groups at a 5% level (p<0.05)|
1742582|NCT00425100|3205103|Superiority or Other||Mean Difference (Net)|-15.2|Standard Deviation|14.2|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.|
1742583|NCT00425100|3205105|Superiority or Other||Mean Difference (Net)|-28.7|Standard Deviation|22.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.|
1742584|NCT00425100|3205106|Superiority or Other||Mean Difference (Net)|26.1|Standard Deviation|22.8|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.|
1742585|NCT00425100|3205107|Superiority or Other||Mean Difference (Net)|16.8|Standard Deviation|21.1|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.|
1742586|NCT00425100|3205108|Superiority or Other||Mean Difference (Net)|24.9|Standard Deviation|27.3|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.|
1742611|NCT00425061|3205151|Superiority or Other||Least squares (LS) mean difference|-5.2||||0.612|2-Sided|95.0|-25.6|15.2|||ANCOVA|||Day 112: Analysis of co-variance (ANCOVA) model was used with baseline as a covariate, long-acting beta-agonist (LABA) use (Inhaled Corticosteroid [ICS] only or ICS plus LABA) and treatment as two factors.|
1742587|NCT00425100|3205109|Superiority or Other||Mean Difference (Net)|30.6|Standard Deviation|26.6|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.|
1742588|NCT00425100|3205110|Superiority or Other||Mean Difference (Net)|28.6|Standard Deviation|26.4|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.|
1742589|NCT00425100|3205112|Superiority or Other||Mean Difference (Net)|0.5|Standard Deviation|0.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.|
1742590|NCT00425100|3205114|Superiority or Other||Mean Difference (Net)|-1.8|Standard Deviation|1.3|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.|
1742591|NCT00425100|3205115|Superiority or Other||Mean Difference (Net)|-0.7|Standard Deviation|0.7|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.|
1742592|NCT00425100|3205116|Superiority or Other||Mean Difference (Net)|-3.5|Standard Deviation|4.1|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2-sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.|
1742593|NCT00425100|3205117|Superiority or Other||Mean Difference (Net)|-0.8|Standard Deviation|1.2|<|0.0001||||||P-value was not adjusted for multiple comparisons. All paired t-tests were performed with a two-sided test at significance level of 5%.|2 sided paired t-test|||This is an open-label study with statistical comparison between baseline and Week 12.|
1742594|NCT00425100|3205119|Superiority or Other||Mean Difference (Net)|-5.0|Standard Deviation|4.8|<|0.0001||95.0|-5.4|-4.5||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency episodes per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.|
1742595|NCT00425100|3205120|Superiority or Other||Mean Difference (Net)|-1.7|Standard Deviation|2.4|<|0.0001||95.0|-2.0|-1.4||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of urgency urinary incontinence per 24 hours is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.|
1742596|NCT00425100|3205121|Superiority or Other||Mean Difference (Net)|-3.0|Standard Deviation|3.1|<|0.0001||95.0|-3.2|-2.7||All paired t-tests were performed with a two-sided test at significance level of 5%. Efficacy was claimed only when all 3 primary diary endpoints demonstrated statistical significance in change from baseline to Week 12.|2-sided paired t-test|paired t-test comparing baseline with post-baseline values||Open-label study with statistical comparison between baseline and Week 12. Null hypothesis: The mean change from baseline in number of micturition episodes per 24 hours at Week 12 is equal to 0. The sample size was based on a statistical power for each of the three individual diary endpoints of .95 which would yield an overall power of 85%.|
1742597|NCT00425061|3205144|Superiority or Other|||||||0.029|||||||Chi-squared||||
1742598|NCT00425061|3205145|Superiority or Other|||||||0.267|||||||Chi-squared||||
1742599|NCT00425061|3205146|Superiority or Other||LS mean difference|0.2||||0.249|2-Sided|95.0|-0.2|0.7|||ANCOVA|||Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.|
1742600|NCT00425061|3205146|Superiority or Other||LS mean difference|0.2||||0.388|2-Sided|95.0|-0.2|0.6|||ANCOVA|||Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.|
1742601|NCT00425061|3205146|Superiority or Other||LS mean difference|0.0||||0.921|2-Sided|95.0|-0.4|0.4|||ANCOVA|||Day 56: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.|
1742602|NCT00425061|3205146|Superiority or Other||LS mean difference|0.0||||0.9|2-Sided|95.0|-0.4|0.4|||ANCOVA|||Day 28: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.|
1742603|NCT00425061|3205146|Superiority or Other||LS mean difference|-0.1||||0.354|2-Sided|95.0|-0.4|0.1|||ANCOVA|||Day 8: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.|
1742604|NCT00425061|3205148|Superiority or Other||LS mean difference|2.1||||0.144|2-Sided|95.0|-0.8|5.0|||ANCOVA|||Day 112: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.|
1742605|NCT00425061|3205148|Superiority or Other||LS mean difference|1.8||||0.09|2-Sided|95.0|-0.3|3.9|||ANCOVA|||Day 28: ANCOVA model was based on the log 2 transformed methacholine challenge test values with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.|
1742606|NCT00425061|3205149|Superiority or Other||LS mean difference|-0.1||||0.256|2-Sided|95.0|-0.2|0.1|||ANCOVA|||Day 112: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.|
1742607|NCT00425061|3205149|Superiority or Other||LS mean difference|-0.1||||0.226|2-Sided|95.0|-0.2|0.1|||ANCOVA|||Day 84: ANCOVA model was used with baseline as a covariate, LABA use (ICS only or ICS plus LABA) and treatment as two factors.|
1742620|NCT00424593|3205201|Superiority or Other|||||||0.046||||||P-value for Change from Baseline.|ANOVA|ANOVA based on rank transformation.|||
1742621|NCT00424593|3205202|Superiority or Other|||||||0.262||||||P-value for Depression Subscale Change from Baseline.|ANCOVA||||
1742622|NCT00424593|3205202|Superiority or Other|||||||0.122||||||P-value for Anxiety Subscale Change from Baseline.|ANCOVA||||
1742623|NCT00424593|3205203|Superiority or Other|||||||0.177||||||P-value for Week 13 Change from Baseline.|ANCOVA||||
1742624|NCT00424593|3205204|Superiority or Other|||||||0.002||||||P-value for Work Activity Impairment Week 13 Change from Baseline.|ANCOVA||||
1742625|NCT00424593|3205204|Superiority or Other|||||||0.736||||||P-value for Work Productivity Loss Week 13 Change from Baseline.|ANCOVA||||
1742626|NCT00424593|3205204|Superiority or Other|||||||0.452||||||P-value for Presenteeism Week 13 Change from Baseline.|ANCOVA||||
1742627|NCT00424593|3205204|Superiority or Other|||||||0.063||||||P-value for Absenteeism Week 13 Change from Baseline.|ANCOVA||||
1742628|NCT00424593|3205205|Superiority or Other|||||||0.117||||||P-value for Change from Baseline.|ANCOVA||||
1742629|NCT00424593|3205206|Superiority or Other|||||||0.04||||||P-value for Vitality Change from Baseline.|ANCOVA||||
1742630|NCT00424593|3205206|Superiority or Other|||||||0.053||||||P-value for Social Functioning Change from Baseline.|ANCOVA||||
1742631|NCT00424593|3205206|Superiority or Other|||||||0.306||||||P-value for Role-Physical Change from Baseline.|ANCOVA||||
1742632|NCT00424593|3205206|Superiority or Other|||||||0.17||||||P-value for Role-Emotional Change from Baseline.|ANCOVA||||
1742633|NCT00424593|3205206|Superiority or Other|||||||0.21||||||P-value for Physical Functioning Change from Baseline.|ANCOVA||||
1742634|NCT00424593|3205206|Superiority or Other|||||||0.093||||||P-value for Mental Health Change from Baseline.|ANCOVA||||
1742635|NCT00424593|3205206|Superiority or Other|||||||0.041||||||P-value for General Health Change from Baseline.|ANCOVA||||
1742636|NCT00424593|3205206|Superiority or Other|||||||0.038||||||P-value for Bodily Pain Change from Baseline.|ANCOVA||||
1742637|NCT00424593|3205206|Superiority or Other|||||||0.22||||||P-value for Physical Component Summary Change from Baseline.|ANCOVA||||
1742638|NCT00424593|3205206|Superiority or Other|||||||0.051||||||P-value for Mental Component Summary Change from Baseline.|ANCOVA||||
1742639|NCT00424593|3205207|Superiority or Other|||||||0.329||||||P-value for Week 13 Change from Baseline.|ANCOVA||||
1742640|NCT00424593|3205208|Superiority or Other|||||||0.087|||||||Fisher Exact||||
1742641|NCT00424593|3205209|Superiority or Other|||||||0.06|||||||Fisher Exact||||
1742642|NCT00424593|3205210|Superiority or Other|||||||0.092||||||P-value for Week 13 Change from Baseline.|ANCOVA||||
1742643|NCT00424593|3205211|Superiority or Other|||||||0.005||||||P-value for Average Interference Week 13 Change from Baseline.|ANCOVA||||
1742644|NCT00424593|3205211|Superiority or Other|||||||0.013||||||P-value for Enjoyment of Life Week 13 Change from Baseline.|ANCOVA||||
1742645|NCT00424593|3205211|Superiority or Other|||||||0.051||||||P-value for Sleep Week 13 Change from Baseline.|ANCOVA||||
1742646|NCT00424593|3205211|Superiority or Other|||||||0.005||||||P-value for Relations With People Week 13 Change from Baseline.|ANCOVA||||
1742647|NCT00424593|3205211|Superiority or Other|||||||0.024||||||P-value for Normal Work Week 13 Change from Baseline.|ANCOVA||||
1742648|NCT00424593|3205211|Superiority or Other|||||||0.006||||||P-value for Walking Ability Week 13 Change from Baseline.|ANCOVA||||
1742649|NCT00424593|3205211|Superiority or Other|||||||0.009||||||P-value for Mood Week 13 Change from Baseline.|ANCOVA||||
1742650|NCT00424593|3205211|Superiority or Other|||||||0.068||||||P-value for General Activity Week 13 Change from Baseline.|ANCOVA||||
1742651|NCT00424593|3205211|Superiority or Other|||||||0.002||||||P-value for Pain Right Now Score Week 13 Change from Baseline.|ANCOVA||||
1742652|NCT00424593|3205211|Superiority or Other|||||||0.019||||||P-value for Average Pain Score Week 13 Change from Baseline.|ANCOVA||||
1742653|NCT00424593|3205211|Superiority or Other|||||||0.001||||||P-value for Least Pain Score Week 13 Change from Baseline.|ANCOVA||||
1742654|NCT00424593|3205211|Superiority or Other|||||||0.011||||||P-value for Worst Pain Score Week 13 Change from Baseline.|ANCOVA||||
1742655|NCT00424593|3205212|Superiority or Other|||||||0.007||||||P-value for Night Pain Score Change from Baseline.|ANCOVA||||
1742656|NCT00424593|3205212|Superiority or Other|||||||0.014||||||P-value for Worst Pain Score Change from Baseline.|ANCOVA||||
1742657|NCT00424593|3205212|Superiority or Other|||||||0.002||||||P-value for Average Pain Score Change from Baseline.|ANCOVA||||
1742658|NCT00424593|3205213|Superiority or Other|||||||0.009||||||P-value is for 13 Week Change from Baseline.|ANCOVA||||
1742659|NCT00424593|3205214|Superiority or Other|||||||0.014|||||||ANCOVA||||
1742660|NCT00424593|3205215|Superiority or Other|||||||0.004||||||Model included treatment, non-steriodal anti-inflammatory drug (NSAID) use (Yes/No), investigator, visit, treatment-by-visit interaction, baseline pain severity, and baseline-by-visit interaction.|Repeated Measures Analysis||||
1742661|NCT00424554|3205220|Superiority or Other|||||||0.09|||||||t-test, 2 sided||||
1742662|NCT00424528|3205227|Superiority or Other|||||||0.025|||||||ANCOVA|Study baseline Inspiratory Capacity as a covariate and treatment group as a fixed effect.|||
1742663|NCT00424528|3205227|Superiority or Other|||||||0.206|||||||ANCOVA|Study baseline Inspiratory Capacity as a covariate and treatment group as a fixed effect.|||
1742664|NCT00424528|3205230|Superiority or Other|||||||0.002|||||||ANCOVA|Week 2 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 2 comparisons|
1742665|NCT00424528|3205230|Superiority or Other|||||||0.004|||||||ANCOVA|Week 2 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 2 comparisons|
1742666|NCT00424528|3205230|Superiority or Other||||||<|0.001|||||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 0|
1742667|NCT00424528|3205230|Superiority or Other||||||<|0.06|||||||ANCOVA|Week 0 comparisons: Study baseline FEV1 as a covariate and treatment group as a fixed effect.||Week 0 comparisons|
1742741|NCT00424294|3205332|Superiority or Other|||||||0.272|||||||Chi-squared|||Week 4: p-value was calculated by Chi-square test.|
1742668|NCT00424528|3205233|Superiority or Other|||||||0.05|||||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.|||
1742669|NCT00424528|3205233|Superiority or Other|||||||0.073|||||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.|||
1742670|NCT00424528|3205234|Superiority or Other||||||<|0.001|||||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.|||
1742671|NCT00424528|3205234|Superiority or Other||||||<|0.001|||||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.|||
1742672|NCT00424528|3205235|Superiority or Other|||||||0.001|||||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.|||
1742673|NCT00424528|3205235|Superiority or Other||||||<|0.001|||||||ANCOVA|Study baseline FEV1 as a covariate and treatment group as a fixed effect.|||
1742674|NCT00424528|3205236|Superiority or Other||||||<|0.001||||||Primary analysis:Group 2 vs 3. Key secondary analysis: Group 1 vs 3. Multiple comparisons for the analysis of the primary endpoint were controlled at the 5% level.|ANCOVA|Study baseline FEV1 as a covariate and treatment group as fixed effect.|||
1742675|NCT00424528|3205236|Superiority or Other||||||<|0.001|||||||ANCOVA|Study Baseline FEV1 as a covariate and treatment group as a fixed effect.|||
1742676|NCT00424528|3205236|Superiority or Other||||||<|0.001|||||||ANCOVA|Study baseline FEV1 as covariate and treatment group as fixed effect.|||
1742677|NCT00424502|3205240|Superiority or Other||Mean Difference (Final Values)|1.81|Standard Deviation|8.21||0.337|2-Sided|95.0|-2.03|5.65|||t-test, 2 sided|||Change from baseline to Week 24|
1742678|NCT00424502|3205241|Superiority or Other||Mean Difference (Final Values)|14.4|Standard Deviation|23.24||0.012|2-Sided|95.0|3.52|25.28|||t-test, 2 sided|||Change from baseline to Week 24|
1742679|NCT00424502|3205244|Superiority or Other||Mean Difference (Final Values)|0.276|Standard Deviation|0.259|<|0.0001|2-Sided|95.0|0.151|0.401|||t-test, 2 sided|||Change from baseline to Week 24|
1742680|NCT00424502|3205245|Superiority or Other||Mean Difference (Final Values)|2.017|Standard Deviation|1.34|<|0.0001|2-Sided|95.0|1.39|2.64|||t-test, 2 sided|||Change from Baseline to Week 24|
1742681|NCT00424476|3205248|Superiority or Other||Odds Ratio (OR)|1.89||||0.0252|2-Sided|95.0|1.08|3.31|||Regression, Logistic|Adjusted for baseline prednisone dose level and baseline stratification factors.|||
1742682|NCT00424476|3205248|Superiority or Other||Odds Ratio (OR)|1.75||||0.0526|2-Sided|95.0|0.99|3.08|||Regression, Logistic|Adjusted for baseline prednisone dose level and baseline stratification factors.|||
1742683|NCT00424476|3205249|Superiority or Other|||||||0.8127|||||||ANCOVA|Adjusted for the baseline PCS score and baseline stratification factors.|||
1742684|NCT00424476|3205249|Superiority or Other|||||||0.887|||||||ANCOVA|Adjusted for the baseline PCS score and baseline stratification factors.|||
1742685|NCT00424476|3205250|Superiority or Other|||||||0.2712|||||||ANCOVA|Adjusted for baseline PGA score and baseline stratification factors.|||
1742686|NCT00424476|3205250|Superiority or Other|||||||0.0003|||||||ANCOVA|Adjusted for baseline PGA score and baseline stratification factors.|||
1742687|NCT00424476|3205251|Superiority or Other||Odds Ratio (OR)|1.51||||0.0189|2-Sided|95.0|1.07|2.14|||Regression, Logistic|Adjusted for baseline stratification factors.|||
1742688|NCT00424476|3205251|Superiority or Other||Odds Ratio (OR)|1.71||||0.0024|2-Sided|95.0|1.21|2.41|||Regression, Logistic|Adjusted for baseline stratification factors.|||
1742689|NCT00424476|3205252|Superiority or Other||Odds Ratio (OR)|1.55||||0.0129|2-Sided|95.0|1.1|2.19||After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05).|Regression, Logistic|Adjusted for baseline stratification factors.|||
1742690|NCT00424476|3205252|Superiority or Other||Odds Ratio (OR)|1.83||||0.0006||95.0|1.3|2.59||For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.|Regression, Logistic|Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: <2g vs ≥2g per 24hr; Race: African/indig-American vs Other)|||
1742691|NCT00424294|3205321|Superiority or Other|||||||0.1|||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742692|NCT00424294|3205321|Superiority or Other|||||||0.267|||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742693|NCT00424294|3205321|Superiority or Other|||||||0.466|||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742694|NCT00424294|3205321|Superiority or Other|||||||0.08|||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742695|NCT00424294|3205321|Superiority or Other|||||||0.291|||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742696|NCT00424294|3205322|Superiority or Other|||||||0.977|||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742697|NCT00424294|3205322|Superiority or Other|||||||0.834|||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742698|NCT00424294|3205322|Superiority or Other|||||||0.948|||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742699|NCT00424294|3205322|Superiority or Other|||||||0.167|||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742700|NCT00424294|3205322|Superiority or Other|||||||0.701|||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742701|NCT00424294|3205323|Superiority or Other|||||||0.501|||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742702|NCT00424294|3205323|Superiority or Other|||||||0.342|||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742703|NCT00424294|3205323|Superiority or Other|||||||0.573|||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742704|NCT00424294|3205323|Superiority or Other|||||||0.108|||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742705|NCT00424294|3205323|Superiority or Other|||||||0.052|||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742706|NCT00424294|3205324|Superiority or Other|||||||0.801|||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742707|NCT00424294|3205324|Superiority or Other|||||||0.632|||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742708|NCT00424294|3205324|Superiority or Other|||||||0.53|||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742709|NCT00424294|3205324|Superiority or Other|||||||0.666|||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742710|NCT00424294|3205324|Superiority or Other|||||||0.369|||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742711|NCT00424294|3205325|Superiority or Other|||||||0.994|||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742712|NCT00424294|3205325|Superiority or Other|||||||0.909|||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742713|NCT00424294|3205325|Superiority or Other|||||||0.532|||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742714|NCT00424294|3205325|Superiority or Other|||||||0.386|||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742715|NCT00424294|3205325|Superiority or Other|||||||0.325|||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742716|NCT00424294|3205326|Superiority or Other|||||||0.861|||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742717|NCT00424294|3205326|Superiority or Other|||||||0.428|||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742718|NCT00424294|3205326|Superiority or Other|||||||0.948|||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742719|NCT00424294|3205326|Superiority or Other|||||||0.738|||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742720|NCT00424294|3205326|Superiority or Other|||||||0.172|||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742721|NCT00424294|3205327|Superiority or Other|||||||0.558|||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742722|NCT00424294|3205327|Superiority or Other|||||||0.715|||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742723|NCT00424294|3205327|Superiority or Other|||||||0.914|||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742724|NCT00424294|3205327|Superiority or Other|||||||0.743|||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742725|NCT00424294|3205327|Superiority or Other|||||||0.507|||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742726|NCT00424294|3205328|Superiority or Other|||||||0.17|||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742727|NCT00424294|3205328|Superiority or Other|||||||0.018|||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742728|NCT00424294|3205328|Superiority or Other|||||||0.031|||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742729|NCT00424294|3205328|Superiority or Other|||||||0.032|||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742730|NCT00424294|3205328|Superiority or Other|||||||0.252|||||||ANCOVA|||Week 1: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742731|NCT00424294|3205329|Superiority or Other|||||||0.96|||||||ANCOVA|||Week 12: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742732|NCT00424294|3205329|Superiority or Other|||||||0.597|||||||ANCOVA|||Week 8: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742733|NCT00424294|3205329|Superiority or Other|||||||0.957|||||||ANCOVA|||Week 4: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742734|NCT00424294|3205329|Superiority or Other|||||||0.044|||||||ANCOVA|||Week 2: ANCOVA with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742735|NCT00424294|3205329|Superiority or Other|||||||0.635|||||||ANCOVA|||Week 1: Analysis of covariance (ANCOVA) with treatment and site as independent variables and baseline as the covariate was used for the analysis.|
1742736|NCT00424294|3205330|Superiority or Other|||||||0.746|||||||Fisher Exact|||Week 12: p-value was calculated by Fisher exact test.|
1742737|NCT00424294|3205331|Superiority or Other|||||||0.338|||||||Fisher Exact|||Week 12: p-value was calculated by Fisher exact test.|
1742738|NCT00424294|3205331|Superiority or Other|||||||0.323|||||||Fisher Exact|||Week 8: p-value was calculated by Fisher exact test.|
1742739|NCT00424294|3205331|Superiority or Other|||||||0.939|||||||Fisher Exact|||Week 4: p-value was calculated by Fisher exact test.|
1742740|NCT00424294|3205332|Superiority or Other|||||||0.265|||||||Chi-squared|||Week 8: p-value was calculated by Chi-square test.|
1742745|NCT00424268|3205334|Superiority or Other||Mean Difference (Net)|-2.6|Standard Error of the Mean|0.9||0.0051|2-Sided|95.0|-4.5|-0.8||This secondary endpoint was analyzed in an exploratory manner.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).|||
1742746|NCT00424268|3205335|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.1||0.0032|2-Sided|95.0|0.1|0.7||This secondary endpoint was analyzed in an exploratory manner.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).|||
1742747|NCT00424268|3205336|Superiority or Other||Rate ratio|0.768|Standard Error of the Mean|0.157||0.1957|2-Sided|95.0|0.515|1.146||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|Poisson regression||||
1742748|NCT00424268|3205337|Superiority or Other||Mean Difference (Net)|81.0|Standard Error of the Mean|15.0|<|0.0001|2-Sided|95.0|51.0|110.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).|||
1742749|NCT00424268|3205338|Superiority or Other||Mean Difference (Net)|80.0|Standard Error of the Mean|15.0|<|0.0001|2-Sided|95.0|51.0|110.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).|||
1742750|NCT00424255|3205359|Superiority or Other||Hazard Ratio (HR)|1.1|||||2-Sided|95.0|0.85|1.43|||||Hazard Ratios were estimated using a Pike estimator.||
1742751|NCT00424255|3205359|Superiority or Other|||||||0.4502||||||The two-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.|Non-stratified log-rank test||||
1742752|NCT00424255|3205359|Superiority or Other|||||||0.2251||||||The one-sided p-value is unstratified as there are too few events per stratum to perform a stratified test.|Non-stratified log-rank test||||
1742753|NCT00424190|3205367|Non-Inferiority or Equivalence|A two-sided 95% confidence interval (CI) for the observed difference in the primary outcome measure between ceftaroline and vancomycin plus aztreonam was calculated. Noninferiority was concluded if the lower limit of the 95% CI was higher than –10%.|Risk Difference (RD)|1.0|||||2-Sided|95.0|-4.2|6.2|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Vancomycin plus Aztreonam clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in clinical cure rate of ceftaroline in comparison with vancomycin plus aztreonam in adult subjects with cSSSI.|
1742754|NCT00424177|3205374|Superiority or Other||Proportion of subjects in Cycle 2 or 3|0.87||||||95.0|0.74|0.94|||||||
1742755|NCT00424047|3205375|Superiority or Other||Hazard Ratio (HR)|0.619||||0.032|2-Sided|95.0|0.398|0.964|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)||
1742756|NCT00424047|3205376|Superiority or Other||Hazard Ratio (HR)|1.135||||0.359|2-Sided|95.0|0.866|1.486||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)||
1742757|NCT00424047|3205377|Superiority or Other||Hazard Ratio (HR)|1.166||||0.271|2-Sided|95.0|0.887|1.532||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone: placebo/dexamethasone)||
1742758|NCT00424047|3205378|Superiority or Other||Hazard Ratio (HR)|0.362|||<|0.001|2-Sided|95.0|0.27|0.478||The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Log Rank||Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)||
1742759|NCT00424047|3205379|Superiority or Other||Hazard Ratio (HR)|0.558||||0.021|2-Sided|95.0|0.338|0.921|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone : placebo/dexamethasone).||
1742760|NCT00424047|3205382|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Probability from Wilcoxon rank sum test|||
1742761|NCT00424047|3205383|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|Probability from Wilcoxon rank sum test|||
1742762|NCT00424047|3205384|Superiority or Other||Hazard Ratio (HR)|0.863||||0.302|2-Sided|95.0|0.651|1.143|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)||
1742763|NCT00424047|3205385|Superiority or Other||Hazard Ratio (HR)|0.73||||0.105|2-Sided|95.0|0.498|1.07|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dexamethasone:Placebo/Dexamethasone)||
1742764|NCT00424047|3205386|Superiority or Other||Hazard Ratio (HR)|0.324|||<|0.001|2-Sided|95.0|0.24|0.438|||Log Rank|The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups|Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dex:Placebo/Dexamethasone)||
1742765|NCT00424021|3205392|Superiority or Other||Mean Difference (Net)|-1.9|Standard Deviation|23.69|||2-Sided|95.0|-8.4|4.6||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.|
1742766|NCT00424021|3205393|Superiority or Other||Mean Difference (Net)|-5.1|Standard Deviation|25.31|||2-Sided|95.0|-12.0|1.8||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.|
1742767|NCT00424021|3205394|Superiority or Other||Mean Difference (Net)|-7.4|Standard Deviation|25.79|||2-Sided|95.0|-14.4|-0.3||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.|
1742768|NCT00424021|3205395|Superiority or Other||Mean Difference (Net)|-0.6|Standard Deviation|19.41|||2-Sided|95.0|-5.9|4.7||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.|
1742769|NCT00424021|3205402|Superiority or Other||Mean Difference (Net)|0.46|Standard Deviation|1.721|||2-Sided|95.0|-0.01|0.93||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.|
1742770|NCT00424021|3205403|Superiority or Other||Mean Difference (Net)|0.5|Standard Deviation|1.888|||2-Sided|95.0|-0.02|1.02||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.|
1742771|NCT00424021|3205404|Superiority or Other||Mean Difference (Net)|0.46|Standard Deviation|1.659|||2-Sided|95.0|0.01|0.92||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.|
1742772|NCT00424021|3205405|Superiority or Other||Mean Difference (Net)|0.21|Standard Deviation|1.323|||2-Sided|95.0|-0.15|0.57||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.|
1742773|NCT00424021|3205407|Superiority or Other||Mean Difference (Net)|-13.9|Standard Deviation|77.04|||2-Sided|95.0|-34.9|7.1||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.|
1742774|NCT00424021|3205408|Superiority or Other||Mean Difference (Net)|-4.7|Standard Deviation|83.08|||2-Sided|95.0|-27.4|18.0||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.|
1742775|NCT00424021|3205409|Superiority or Other||Mean Difference (Net)|-10.3|Standard Deviation|73.16|||2-Sided|95.0|-30.3|9.7||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.|
1742776|NCT00424021|3205410|Superiority or Other||Mean Difference (Net)|4.5|Standard Deviation|46.93|||2-Sided|95.0|-8.3|17.3||||||The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.|
1742777|NCT00423813|3205457|Superiority or Other|||||||0.001|||||||Chi-squared|||Pairwise comparison of Xyrem 6.0g and placebo|
1742778|NCT00423813|3205457|Superiority or Other||||||<|0.001|||||||Chi-squared|||Pairwise comparison of Xyrem 4.5g and placebo|
1742779|NCT00423813|3205457|Superiority or Other||||||<|0.001|||||||Chi-squared|||Overall Comparison|
1742780|NCT00423735|3205461|Superiority|||||||0.99|||||||Fisher Exact|2-sided test|||
1742781|NCT00423670|3205482|Superiority or Other||Percent difference in SVR rates|15.6||||0.0009|2-Sided|95.0|6.5|24.8|||Cochran-Mantel-Haenszel Chi-Square Test|Adjusted for the baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.|||
1742782|NCT00423670|3205483|Superiority or Other||Percent difference in SVR rates|5.1||||0.2864|2-Sided|95.0|-4.2|14.3|||Cochran-Mantel-Haenszel Chi-Square Test|Adjusted for baseline stratification factors: black versus non black, and cirrhosis versus no cirrhosis.|||
1742783|NCT00423670|3205484|Superiority or Other||Percent difference in SVR|37.3|||<|0.0001|2-Sided|95.0|24.7|49.8|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.|||
1742784|NCT00423670|3205484|Superiority or Other||Percent difference in SVR|29.5|||<|0.0001|2-Sided|95.0|16.5|42.5|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.|||
1742785|NCT00423670|3205484|Superiority or Other||Percent difference in SVR|18.8|||<|0.0048|2-Sided|95.0|5.5|32.2|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.|||
1742786|NCT00423670|3205484|Superiority or Other||Percent difference in SVR|16.7|||<|0.0126|2-Sided|95.0|3.5|30.0|||Cochran-Mantel Haenszel Chi-square test|Adjusted for baseline stratification factors: black versus non-black, and cirrhosis versus no cirrhosis.|||
1742787|NCT00423657|3205492|Non-Inferiority or Equivalence|A two-sided 95% confidence interval (CI) for the observed difference in the primary outcome measure between ceftaroline and vancomycin plus aztreonam was calculated. Noninferiority was concluded if the lower limit of the 95%CI was higher than –10%.|Risk Difference (RD)|-0.4|||||2-Sided|95.0|-5.8|5.0|||||Risk difference corresponds to Ceftaroline clinical cure rate minus Vancomycin plus Aztreonam clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.|The primary objective of this study was to determine the noninferiority in clinical cure rate of ceftaroline in comparison with vancomycin plus aztreonam in adult subjects with cSSSI.|
1742788|NCT00423592|3205494|Superiority or Other||Mean Difference (Final Values)|3.9|Standard Deviation|5.78||0.001|2-Sided|95.0|1.7|6.2|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.|
1742812|NCT00423319|3205538|Superiority or Other||Risk Ratio (RR)|0.4|||<|0.0001|2-Sided|95.0|0.15|0.8||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin||
1742789|NCT00423592|3205495|Superiority or Other||Mean Difference (Final Values)|3.9|Standard Deviation|13.96||0.152|2-Sided|95.0|-1.5|9.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.|
1742790|NCT00423592|3205496|Superiority or Other||Mean Difference (Final Values)|3.5|Standard Deviation|9.41||0.059|2-Sided|95.0|-0.1|7.2|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.|
1742791|NCT00423592|3205497|Superiority or Other||Mean Difference (Final Values)|4.5|Standard Deviation|7.23||0.003|2-Sided|95.0|1.7|7.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.|
1742792|NCT00423592|3205498|Superiority or Other||Mean Difference (Final Values)|3.0|Standard Deviation|7.45||0.046|2-Sided|95.0|0.1|5.8|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.|
1742793|NCT00423592|3205499|Superiority or Other||Mean Difference (Final Values)|3.1|Standard Deviation|6.4||0.017|2-Sided|95.0|0.6|5.6|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.|
1742794|NCT00423592|3205500|Superiority or Other||Mean Difference (Final Values)|7.2|Standard Deviation|10.56||0.001|2-Sided|95.0|3.1|11.3|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.|
1742795|NCT00423592|3205501|Superiority or Other||Mean Difference (Final Values)|4.4|Standard Deviation|6.86||0.002|2-Sided|95.0|1.7|7.0|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.|
1742796|NCT00423592|3205502|Superiority or Other||Mean Difference (Final Values)|3.4|Standard Deviation|8.98||0.059|2-Sided|95.0|-0.1|6.8|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.|
1742797|NCT00423592|3205503|Superiority or Other||Mean Difference (Final Values)|4.6|Standard Deviation|6.44||0.001|2-Sided|95.0|2.1|7.1|||t-test, 2 sided|||Seven subjects were evaluated by the incorrect version of the SF-36 questionnaire at the baseline visit and were not included in the analysis; therefore n = 28 for mean baseline scores, and n = 28 for mean change from baseline at Week 12.|
1742798|NCT00423592|3205505|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Deviation|1.51||0.046|2-Sided|95.0|-1.0|0.0|||t-test, 2 sided|||Hypothesis testing and descriptive statistics were carried out on the last-observation-carried-forward (LOCF) Borg dyspnea index change from baseline.|
1742799|NCT00423592|3205506|Superiority or Other||Mean Difference (Final Values)|23.4|Standard Deviation|49.6||0.009|2-Sided|95.0|6.3|40.4|||t-test, 2 sided|||Hypothesis testing and descriptive statistics were carried out on the last-observation-carried-forward (LOCF) 6-minute walk distance change from baseline.|
1742800|NCT00423592|3205509|Superiority or Other||Proportion|0.0|Standard Deviation|0.0||0.01|2-Sided|95.0|0.0|9.7|||Exact binomial test|A 1-sample test for a binomial proportion was performed.||Sample size: 30 participants; 80% power to rule out 50% recurrence rate of serum ALT/AST abnormalities following ambrisentan treatment (assumes 25% recurrence rate); 99% power to rule out 75% recurrence rate (assumes 37.5% recurrence rate). H_0 = proportion of subjects experiencing primary endpoint at 12% vs 1-sided alternative of < 12%. P-value from exact binomial test. Summary statistics included the estimated proportion, 95% confidence interval (CI), and the p-value of the hypothesis test.|
1742801|NCT00423579|3205510|Superiority or Other||Mean Difference (Net)|-14.5||||0||95.0|-18.9|-10.1|||Student's t test for independent data||Difference in percentage change in mean LDL-C values (change from baseline to week 6) between the two treatment groups. (Ezetimibe [EZ]/Simvastatin [S] [10/20mg] + S [placebo] group minus the EZ/S [10mg/placebo] + S [40mg] group)||
1742802|NCT00423488|3205511|Superiority or Other||least-squares means|-11.5||||0.005||95.0|-19.4|-3.5|||ANOVA|The analysis of variance (ANOVA) model included term of treatment effect. If more than one basal value was available, the latest was used.|||
1742803|NCT00423319|3205526|Superiority or Other||Difference in event rates|-0.04|||||2-Sided|95.0|-0.26|0.17|||||Apixaban-enoxaparin. Thrombocytopenia||
1742804|NCT00423319|3205526|Superiority or Other||Difference in event rates|-0.11|||||2-Sided|95.0|-0.35|0.07|||||Apixaban-enoxaparin. Stroke||
1742805|NCT00423319|3205526|Superiority or Other||Difference in event rates|0.07|||||2-Sided|95.0|-0.17|0.34|||||Apixaban-enoxaparin. MI||
1742806|NCT00423319|3205526|Superiority or Other||Difference in event rates|-0.04|||||2-Sided|95.0|-0.34|0.26|||||Apixaban-enoxaparin. MI/stroke||
1742807|NCT00423319|3205536|Superiority or Other||Difference in event rate|-0.85||||0.34|2-Sided|95.0|-2.61|0.9||2-sided P-Value|Chi-squared||Any bleeding. Apixaban-enoxaparin||
1742808|NCT00423319|3205536|Superiority or Other||Difference in event rates|-0.21||||0.72|2-Sided|95.0|-1.38|0.95||2-sided P-Value|Chi-squared||Major or CRNM. Apixaban-enoxaparin||
1742809|NCT00423319|3205536|Superiority or Other||Difference in event rates|-0.44||||0.43|2-Sided|95.0|-1.53|0.66||2-sided P-Value|Chi-squared||CRNM. Apixaban-enoxaparin||
1742810|NCT00423319|3205536|Superiority or Other||Difference in event rates|0.15||||0.54|2-Sided|95.0|-0.33|0.64||2-sided P-Value|Chi-squared||Major bleeding. Apixaban-enoxaparin||
1742811|NCT00423319|3205538|Superiority or Other||Risk difference|-0.68||||0.0054|2-Sided|95.0|-1.27|-0.17||Statistically significant at the 1-sided 0.025 level|Chi-squared||Apixaban-enoxaparin||
1742908|NCT00420927|3205874|Superiority or Other|||||||0.349|||||||ANCOVA|Analysis of covariance adjusting for baseline|||
1742813|NCT00423319|3205539|Superiority or Other||Risk Difference|-2.47|||<|0.0001|2-Sided|95.0|-3.54|1.5||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin||
1742814|NCT00423319|3205539|Superiority or Other||Risk Ratio (RR)|0.36|||<|0.0001|2-Sided|95.0|0.22|0.54||Statistically significant at the 1-sided 0.025 level|Farrington-Manning test||Apixaban-enoxaparin||
1742815|NCT00423293|3205549|Superiority|||||||0.23|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with any grade 3+ adverse events were compared to the historical rate of 87%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.|
1742816|NCT00423293|3205549|Superiority|||||||0.12|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with any grade 2+ adverse events were compared to the historical rate of 98%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.|
1742817|NCT00423293|3205549|Superiority|||||||0.1|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with skin grade 2+ adverse events were compared to the historical rate of 83%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.|
1742818|NCT00423293|3205549|Superiority|||||||0.032|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with hematologic grade 2+ adverse events were compared to the historical rate of 85%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.|
1742819|NCT00423293|3205549|Superiority|||||||0.18|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with GU grade 2+ adverse events were compared to the historical rate of 20%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.|
1742820|NCT00423293|3205549|Superiority|||||||0.5|||||||Chi-squared|One-sided significance level = 0.05||Percentage of patients with GI grade 2+ adverse events were compared to the historical rate of 73%. Null hypothesis: same or greater than historical rate. Alternative hypothesis: less than historical rate.|
1742821|NCT00423293|3205551|Superiority or Other|||||||0.5||||||One-sided p-value comparing to a rate of 78% (the historical rate was updated after the study design).|Chi-squared|||The RT+ 5-FU + Mitomycin-C arm on previous Radiation Therapy Oncology Group (RTOG) study 9811 [NCT00003596] had a 77% rate of >= grade 2 GI and GU adverse events. The null hypothesis for this study design was a 15% reduction for that rate. Fifty-four evaluable patients provides 80% power to detect a 15% reduction, using a one-sided chi-squared test with a type I error rate of 0.05. (With 52 patients, the power is reduced to 78%.)|
1742822|NCT00423176|3205565|Superiority or Other||Mean Difference (Net)|8.8||||||95.0|-0.5|18.2|||||Change from baseline to endpoint||
1742823|NCT00423176|3205566|Superiority or Other||Mean Difference (Net)|-0.82||||||95.0|-1.65|0.0|||||For follow-up days 30-43||
1742824|NCT00423176|3205566|Superiority or Other||Mean Difference (Net)|-0.44||||||95.0|-1.14|0.25|||||For days 1-29||
1742825|NCT00422812|3205642|Superiority|||||||0.0003||||||No adjustments were made for multiple comparisons|Log Rank||||
1742826|NCT00422812|3205642|Superiority|||||||0.0008||||||No adjustments were made for multiple comparisons|Log Rank||||
1742827|NCT00422812|3205642|Superiority|||||||0.0008|||||||Log Rank|No adjustments were made for multiple comparisons|||
1742828|NCT00422812|3205642|Superiority|||||||0.0007||||||Overall effect (0-4 hr) for TREATMENT by Log-rank p-value|Log Rank|There was no adjustment for multiple comparisons.|||
1742829|NCT00422812|3205643|Superiority|||||||0.0019|||||||Fisher Exact||||
1742830|NCT00422812|3205643|Superiority|||||||0.0226|||||||Fisher Exact||||
1742831|NCT00422812|3205643|Superiority|||||||0.281|||||||Fisher Exact||||
1742832|NCT00422812|3205644|Superiority|||||||0.0012||||||Overall effect at 2 hr (by Cochran-Mantel-Haenszel) for TREATMENT|Cochran-Mantel-Haenszel||||
1742833|NCT00422734|3205649|Superiority or Other||||||<|0.001||||||P-value is for SEAR Overall Relationship|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.|||
1742834|NCT00422734|3205649|Superiority or Other||||||<|0.001||||||P-value is for SEAR Self-Esteem|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.|||
1742835|NCT00422734|3205650|Superiority or Other||||||<|0.001||||||P-value is for SEAR Confidence|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.|||
1742836|NCT00422734|3205650|Superiority or Other||||||<|0.001||||||P-value is for SEAR Sexual Relationship|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.|||
1742837|NCT00422734|3205650|Superiority or Other||||||<|0.001||||||P-value is for SEAR Total Score|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.|||
1742838|NCT00422734|3205651|Superiority or Other||||||<|0.001||||||P-value is for SEP Question 2|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.|||
1742839|NCT00422734|3205651|Superiority or Other||||||<|0.001||||||P-value is for SEP Question 1|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.|||
1742840|NCT00422734|3205652|Superiority or Other||||||<|0.001||||||P-value is for GAQ Question 2|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10|||
1742841|NCT00422734|3205652|Superiority or Other||||||<|0.001||||||P-value is for GAQ Question 1|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10|||
1742842|NCT00422734|3205653|Superiority or Other||||||<|0.001||||||P-value is for GAQ Question 2|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10|||
1742863|NCT00422383|3205730|Superiority or Other||Weighted Difference|0.07||||0.2419|2-Sided|95.0|-0.05|0.19|||Cochran-Mantel-Haenszel||Analysis stratified by region, prior biologic use, RF status, and treatment.||
1742843|NCT00422734|3205653|Superiority or Other||||||<|0.001||||||P-value is for GAQ Question 1|Regression, Logistic|Model included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10|||
1742844|NCT00422734|3205654|Superiority or Other||||||<|0.001|||||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.|||
1742845|NCT00422734|3205655|Superiority or Other||||||<|0.001|||||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.|||
1742846|NCT00422734|3205656|Superiority or Other||||||<|0.001||||||p-value for SEP Question 5|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.|||
1742847|NCT00422734|3205656|Superiority or Other||||||<|0.001||||||p-value for SEP Question 4|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.|||
1742848|NCT00422734|3205657|Superiority or Other||||||<|0.001||||||P-value for SEP Question 3. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.|
1742849|NCT00422734|3205657|Superiority or Other||||||<|0.001||||||P-value for SEP Question 2. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.|
1742850|NCT00422734|3205658|Superiority or Other||||||<|0.001||||||p-value is for partner scores|ANCOVA|ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10|||
1742851|NCT00422734|3205658|Superiority or Other||||||<|0.001||||||p-value is for subject scores|ANCOVA|ANCOVA included:treatment, baseline value of IIEF EF Domain, pooled site. Baseline-value-by-treatment interaction included if interaction at p<0.10|||
1742852|NCT00422734|3205659|Superiority or Other||||||<|0.001|||||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.|||
1742853|NCT00422734|3205660|Superiority or Other||||||<|0.001|||||||ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.|||
1742854|NCT00422734|3205661|Superiority or Other||||||<|0.001||||||P-value for Partner. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.|
1742855|NCT00422734|3205661|Superiority or Other||||||<|0.001||||||P-value for Subject. Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. To adjust for multiplicity, statistical significance at 0.025 level was required for this variable.|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.|
1742856|NCT00422734|3205662|Superiority or Other||||||<|0.001||||||Hypotheses were tested in a sequential fashion using a gatekeeping strategy and adjusted for multiplicity. Statistical significance at 0.05 level was required for this variable|ANCOVA|Change from baseline ANCOVA model: treatment group, baseline value, pooled site. Baseline-by-treatment interaction included if interaction at p<0.10.||The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.|
1742857|NCT00422695|3205663|Superiority or Other||||||<|0.05|||||||ANOVA||||
1742858|NCT00422695|3205663|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1742859|NCT00422383|3205726|Superiority or Other|||||||0.0495||||||Stratified by region, prior biologic use, RF status, and treatment.|Cochran-Mantel-Haenszel||||
1742860|NCT00422383|3205726|Superiority or Other|||||||0.5029||||||Stratified by region, prior biologic use, RF status, and treatment.|Cochran-Mantel-Haenszel||||
1742861|NCT00422383|3205727|Superiority or Other|||||||0.1018||||||Stratified by region, prior biologic use, RF status and treatment.|ANOVA||||
1742862|NCT00422383|3205727|Superiority or Other|||||||0.7127||||||Stratified by region, prior biologic use, RF status and treatment.|ANOVA||||
1742903|NCT00420927|3205871|Superiority or Other|||||||0.028|||||||Regression, Logistic||||
1742864|NCT00422383|3205730|Superiority or Other||Weighted Difference|-0.01||||0.8156|2-Sided|95.0|-0.13|0.1|||Cochran-Mantel-Haenszel||Analysis stratified by region, prior biologic use, rheumatoid factor (RF) status, and treatment.||
1742865|NCT00422227|3205738|Superiority or Other|||||||0.001|||||||ANCOVA|||Fatigue Week 16|
1742866|NCT00422227|3205738|Superiority or Other||||||<|0.001|||||||ANCOVA|||Pain Week 16|
1742867|NCT00422227|3205738|Superiority or Other||||||<|0.001|||||||ANCOVA|||General Health Week 16|
1742868|NCT00422227|3205739|Superiority or Other||||||<|0.001|||||||ANCOVA|||Week 16|
1742869|NCT00422227|3205740|Superiority or Other||||||<|0.001|||||||ANCOVA|||Subject Global Assessment Week 16|
1742870|NCT00422227|3205740|Superiority or Other||||||<|0.001|||||||ANCOVA|||Physician Global Assessment Week 16|
1742871|NCT00422227|3205741|Superiority or Other||||||<|0.001|||||||ANCOVA|||Swollen Joints at Week 16|
1742872|NCT00422227|3205741|Superiority or Other||||||<|0.014|||||||ANCOVA|||Painful Joints at Week 16|
1742873|NCT00422227|3205742|Superiority or Other|||||||0.001|||||||Fisher Exact|||≥1.2|
1742874|NCT00422227|3205742|Superiority or Other|||||||0.003|||||||Fisher Exact|||≥0.6|
1742875|NCT00422227|3205743|Superiority or Other|||||||0.003|||||||Fisher Exact||||
1742876|NCT00422227|3205744|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1742877|NCT00422227|3205745|Superiority or Other|||||||0.069|||||||Fisher Exact|||Remission (DAS28 <2.6)|
1742878|NCT00422227|3205745|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Low Disease (DAS28 <3.2)|
1742879|NCT00422227|3205746|Superiority or Other|||||||0.009|||||||Fisher Exact|||ACR 70|
1742880|NCT00422227|3205746|Superiority or Other||||||<|0.001|||||||Fisher Exact|||ACR 50|
1742881|NCT00422227|3205746|Superiority or Other||||||<|0.001|||||||Fisher Exact|||ACR 20|
1742882|NCT00422227|3205747|Superiority or Other||||||<|0.001|||||||ANOVA||||
1742883|NCT00422162|3205755|Superiority or Other|||||||0.28||||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test|||
1742884|NCT00422162|3205755|Superiority or Other||||||<|0.0001||||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test|||
1742885|NCT00422162|3205755|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test|||
1742886|NCT00422162|3205755|Superiority or Other||||||<|0.0001||||||P-value for Change from Baseline (within group)|t-test, 2 sided|paired t-test|||
1742887|NCT00422162|3205765|Superiority or Other|||||||0.88||||||P-value for Change from Baseline. A priori alpha threshold was 0.05 with no adjustment for multiple testing.|ANCOVA|ANCOVA with stratification factors (country and pretreatment for MDD) and MADRS baseline as covariates and treatment regimen as the main factor.|||
1742888|NCT00421928|3205816|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.18|<|0.05||95.0|-1.04|-0.33|||ANCOVA|Analysis of covariance (ANCOVA) model was used with treatment and pooled analysis center as factors and baseline pain intensity score as a covariate.||The primary null hypothesis to be tested for the study was that the tapentadol ER group was not different from the placebo group for the primary endpoint. Assuming the mean treatment group difference of 0.7 with an SD of 2.7, 314 subjects per treatment group were estimated to provide 90% power to show that the tapentadol ER group was statistically different from placebo at an alpha level of 0.05. The total number of subjects to be randomly assigned to a treatment group for the study was 942.|
1742889|NCT00421733|3205827|Superiority or Other||||||<|0.001|||||||ANCOVA|1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.|||
1742890|NCT00421733|3205827|Superiority or Other||||||<|0.001|||||||ANCOVA|1-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.|||
1742891|NCT00421733|3205828|Superiority or Other||Mean Difference (Net)|-0.33||||0.009|2-Sided|95.0|-0.57|-0.08|||ANCOVA|2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction|||
1742892|NCT00421733|3205828|Superiority or Other||Mean Difference (Net)|-0.02||||0.855|2-Sided|95.0|-0.26|0.22|||ANCOVA|2-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction|||
1742893|NCT00421733|3205829|Superiority or Other|||||||0.038|||||||Fisher Exact||||
1742894|NCT00421733|3205829|Superiority or Other|||||||0.102|||||||Fisher Exact||||
1742895|NCT00421733|3205830|Superiority or Other|||||||0.053||||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.|||
1742896|NCT00421733|3205830|Superiority or Other|||||||0.229||||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA with treatment group as the factor and baseline FMV UACR as the covariate.|||
1742897|NCT00421733|3205830|Superiority or Other|||||||0.071||||||There were no P-value adjustments for multiple comparisons.|ANCOVA|1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.|||
1742898|NCT00421603|3205844|Non-Inferiority or Equivalence|All analyses were conducted on the intent-to-treat sample of all randomized patients. All statistical tests were 2-tailed and employed at a significance level of 5%, unless otherwise stated. The original sample size of 120 patients was chosen to ensure sufficient power (at least 80%) of a two-sided test with level of significance α=0.05 for detecting difference between the two experimental treatments with respect to the percentage of subjects who achieve continuous 3-weeks abstinence.|||||=|0|||||||Chi-squared, Corrected|||The dichotomous primary outcome was analyzed using logistic regression with independent predictors: treatment (MAS-ER and topiramate vs. placebo) and adjusted for baseline severity of cocaine use (total number of cocaine use days in the 28 days prior to randomization).|
1742899|NCT00420992|3205869|Superiority or Other|||||||0.0445||||||Threshold for statistical significance: P=0.05. No adjustment for multiple comparisons necessary.|ANCOVA|Model included treatment as factor and baseline pain score as covariate.||Null hypothesis: mean change from baseline is the same for ALO-01 and placebo.|
1742900|NCT00420927|3205870|Superiority or Other|||||||0.077|||||||Regression, Logistic||||
1742901|NCT00420927|3205870|Superiority or Other|||||||0.074|||||||Regression, Logistic||||
1742902|NCT00420927|3205871|Superiority or Other|||||||0.014|||||||Regression, Logistic||||
1742909|NCT00420927|3205874|Superiority or Other|||||||0.036|||||||ANCOVA|Analysis of covariance adjusting for baseline|||
1742910|NCT00420927|3205875|Superiority or Other|||||||0.403|||||||ANCOVA|Analysis of covariance adjusting for baseline|||
1742911|NCT00420927|3205875|Superiority or Other|||||||0.03|||||||ANCOVA|Analysis of covariance adjusting for baseline|||
1742912|NCT00420927|3205876|Superiority or Other|||||||0.235|||||||Regression, Logistic||||
1742913|NCT00420927|3205876|Superiority or Other|||||||0.314|||||||Regression, Logistic||||
1742914|NCT00420927|3205877|Superiority or Other|||||||0.188|||||||Regression, Logistic||||
1742915|NCT00420927|3205877|Superiority or Other|||||||0.301|||||||Regression, Logistic||||
1742916|NCT00420927|3205878|Superiority or Other|||||||0.55|||||||Regression, Logistic||||
1742917|NCT00420927|3205878|Superiority or Other|||||||0.23|||||||Regression, Logistic||||
1742918|NCT00420927|3205879|Superiority or Other|||||||0.271|||||||Regression, Logistic||||
1742919|NCT00420927|3205879|Superiority or Other|||||||0.24|||||||Regression, Logistic||||
1742920|NCT00420927|3205880|Superiority or Other|||||||0.049|||||||ANCOVA|Analysis of covariance adjusting for baseline|||
1742921|NCT00420927|3205880|Superiority or Other|||||||0.004|||||||ANCOVA|Analysis of covariance adjusting for baseline|||
1742922|NCT00420927|3205881|Superiority or Other|||||||0.043|||||||Regression, Logistic||||
1742923|NCT00420927|3205881|Superiority or Other|||||||0.06|||||||Regression, Logistic||||
1742924|NCT00420927|3205882|Superiority or Other|||||||0.217|||||||Regression, Logistic||||
1742925|NCT00420927|3205882|Superiority or Other|||||||0.159|||||||Regression, Logistic||||
1742926|NCT00420927|3205883|Superiority or Other|||||||0.64|||||||Regression, Logistic||||
1742927|NCT00420927|3205883|Superiority or Other|||||||0.395|||||||Regression, Logistic||||
1742928|NCT00420927|3205884|Superiority or Other|||||||0.063|||||||Regression, Logistic||||
1742929|NCT00420927|3205884|Superiority or Other|||||||0.06|||||||Regression, Logistic||||
1742930|NCT00420927|3205885|Superiority or Other|||||||0.009|||||||Regression, Logistic||||
1742931|NCT00420927|3205885|Superiority or Other|||||||0.026|||||||Regression, Logistic||||
1742932|NCT00420927|3205886|Superiority or Other|||||||0.287|||||||Regression, Logistic||||
1742933|NCT00420927|3205886|Superiority or Other|||||||0.28|||||||Regression, Logistic||||
1742934|NCT00420927|3205887|Superiority or Other|||||||0.082|||||||Regression, Logistic||||
1742935|NCT00420927|3205888|Superiority or Other|||||||0.023|||||||Chi-squared|P value is from Pearson's chi-square test.|||
1742936|NCT00420784|3205916|Superiority or Other||Odds Ratio (OR)|1.95||||0.067|2-Sided|95.0|0.95|4.0|||Regression, Logistic||||
1742937|NCT00420784|3205916|Superiority or Other||Odds Ratio (OR)|5.72|||<|0.001|2-Sided|95.0|2.91|11.27|||Regression, Logistic||||
1742938|NCT00420784|3205916|Superiority or Other||Odds Ratio (OR)|6.64|||<|0.001|2-Sided|95.0|3.41|12.96|||Regression, Logistic||||
1742939|NCT00420784|3205918|Superiority or Other||Odds Ratio (OR)|2.31||||0.024|2-Sided|95.0|1.12|4.75|||Regression, Logistic||||
1742940|NCT00420784|3205918|Superiority or Other||Odds Ratio (OR)|9.52|||<|0.001|2-Sided|95.0|4.72|19.2|||Regression, Logistic||||
1742941|NCT00420784|3205918|Superiority or Other||Odds Ratio (OR)|8.23|||<|0.001|2-Sided|95.0|4.14|16.36|||Regression, Logistic||||
1742942|NCT00420641|3205927|Superiority or Other||Odds Ratio (OR)|2.45||||0.0011|2-Sided|90.0|1.56|3.86|||Regression, Logistic|||Placebo versus Paroxetine in percentage of participants Satisfied with Study Medication at Week 10.|
1742943|NCT00420641|3205927|Superiority or Other||Odds Ratio (OR)|0.96||||0.8782|2-Sided|90.0|0.62|1.5|||Regression, Logistic|||Placebo versus GSK372475 in percentage of participants Satisfied with Study Medication at Week 10.|
1742944|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|2.97||||0.0003|2-Sided|90.0|1.81|4.88|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 10.|
1742945|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|1.86||||0.0507|2-Sided|90.0|1.1|3.13|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 10.|
1742946|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|3.69||||0|2-Sided|90.0|2.24|6.08|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 8.|
1742947|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|1.37||||0.28|2-Sided|90.0|0.85|2.23|||Placebo versus GSK372475 in percentage o|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 8.|
1742948|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|2.61||||0.0004|2-Sided|90.0|1.67|4.09|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 6.|
1742949|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|0.97||||0.8992|2-Sided|90.0|0.62|1.51|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 6.|
1742950|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|2.56||||0.0006|2-Sided|90.0|1.63|4.03|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 5.|
1742951|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|1.05||||0.8682||90.0|0.67|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 5.|
1742952|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|1.49||||0.1137|2-Sided|90.0|0.98|2.27|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 4.|
1742953|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|0.77||||0.3099|2-Sided|90.0|0.5|1.18|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 4.|
1742954|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|1.95||||0.0136|2-Sided|90.0|1.25|3.05|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 3.|
1744075|NCT00408876|3207606|Superiority or Other|||||||0.89|||||||Repeated Measures||||
1742955|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|0.96||||0.8989|2-Sided|90.0|0.61|1.53|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 3.|
1742956|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|1.85||||0.06|2-Sided|90.0|1.08|3.16|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 2.|
1742957|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|1.55||||0.1938|2-Sided|90.0|0.89|2.7|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 2.|
1742958|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|1.86||||0.3039|2-Sided|90.0|0.69|5.01|||Generalized estimating equation model|||Placebo versus Paroxetine in percentage of participants with CGI-I at Week 1.|
1742959|NCT00420641|3205928|Superiority or Other||Odds Ratio (OR)|1.29||||0.6928|2-Sided|90.0|0.44|3.76|||Generalized estimating equation model|||Placebo versus GSK372475 in percentage of participants with CGI-I at Week 1.|
1742960|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|1.83||||0.0328|2-Sided|90.0|1.15|2.92|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 10.|
1742961|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.96||||0.9067||90.0|0.57|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 10.|
1742962|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|1.67||||0.0783|2-Sided|90.0|1.03|2.69|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 8.|
1742963|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.69||||0.2147|2-Sided|90.0|0.42|1.13|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 8.|
1742964|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|2.1||||0.0125|2-Sided|90.0|1.29|3.43|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 6.|
1742965|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.61||||0.1182|2-Sided|90.0|0.36|1.03|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 6.|
1742966|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|1.42||||0.3126|2-Sided|90.0|0.8|2.52|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 5.|
1742967|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.72||||0.3857|2-Sided|90.0|0.39|1.34|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 5.|
1742968|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.73||||0.3959|2-Sided|90.0|0.39|1.35|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 4.|
1742969|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.4||||0.0259|2-Sided|90.0|0.2|0.79|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 4.|
1742970|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|1.68||||0.216|2-Sided|90.0|0.84|3.37|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 3.|
1742971|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.81||||0.6384|2-Sided|90.0|0.39|1.69|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 3.|
1742972|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|2.09||||0.1881|2-Sided|90.0|0.83|5.25|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 2.|
1742973|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|1.14||||0.8312|2-Sided|90.0|0.43|3.03|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 2.|
1742974|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.98||||0.978|2-Sided|90.0|0.28|3.41|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 remitters at Week 1.|
1742975|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.58||||0.553|2-Sided|90.0|0.13|2.6|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 remitters at Week 1.|
1742976|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|3.06||||0.0002|2-Sided|90.0|1.86|5.02|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 10.|
1742977|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|1.07||||0.8312|2-Sided|90.0|0.64|1.8|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 10.|
1742978|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|2.57||||0.001|2-Sided|90.0|1.6|4.13|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 8.|
1742979|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.99||||0.9727|2-Sided|90.0|0.6|1.63|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 8.|
1742980|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|2.47||||0.0016|2-Sided|90.0|1.54|3.97|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 6.|
1742981|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.72||||0.2832|2-Sided|90.0|0.44|1.19|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 6.|
1742982|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|1.65||||0.0819|2-Sided|90.0|1.03|2.63|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 5.|
1742983|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.94||||0.8434|2-Sided|90.0|0.58|1.54|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 5.|
1742984|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|1.33||||0.3412|2-Sided|90.0|0.81|2.17|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 4.|
1742985|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.44||||0.0134|2-Sided|90.0|0.26|0.76|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 4.|
1742986|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|1.5||||0.2112|2-Sided|90.0|0.88|2.57|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 3.|
1742987|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.71||||0.3287|2-Sided|90.0|0.4|1.26|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 3.|
1742988|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|1.47||||0.3416|2-Sided|90.0|0.76|2.84|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 2.|
1742989|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|1.09||||0.8428|2-Sided|90.0|0.55|2.16|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 2.|
1742990|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|1.12||||0.8633|2-Sided|90.0|0.38|3.3|||Generalized estimating equation model|||Placebo versus Paroxetine in HAMD-17 responders at Week 1.|
1742991|NCT00420641|3205929|Superiority or Other||Odds Ratio (OR)|0.63||||0.5057|2-Sided|90.0|0.2|1.98|||Generalized estimating equation model|||Placebo versus GSK372475 in HAMD-17 responders at Week 1.|
1742992|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.5||||0.1665|2-Sided|90.0|0.93|2.43|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 10.|
1742993|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|0.97||||0.9222|2-Sided|90.0|0.56|1.66|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 10.|
1742994|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.48||||0.1901|2-Sided|90.0|0.9|2.44|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 8.|
1742995|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|0.78||||0.4431|2-Sided|90.0|0.46|1.32|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 8.|
1742996|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|2.3||||0.0047|2-Sided|90.0|1.42|3.75|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 6.|
1742997|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|0.77||||0.4331|2-Sided|90.0|0.44|1.34|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 6.|
1742998|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.35||||0.362|2-Sided|90.0|0.79|2.31|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 5.|
1742999|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|0.91||||0.7921|2-Sided|90.0|0.49|1.66|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 5.|
1743000|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|0.69||||0.2859|2-Sided|90.0|0.39|1.22|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 4.|
1743001|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|0.41||||0.0208|2-Sided|90.0|0.21|0.77|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 4.|
1743002|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.21||||0.6526|2-Sided|90.0|0.6|2.42|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 3.|
1743003|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|0.76||||0.5608|2-Sided|90.0|0.35|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 3.|
1743004|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.86||||0.2507|2-Sided|90.0|0.77|4.5|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 2.|
1743005|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.93||||0.2305|2-Sided|90.0|0.78|4.75|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 2.|
1743006|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|0.36||||0.1735|2-Sided|90.0|0.11|1.24|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR remitters at Week 1.|
1743007|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|0.27||||0.205|2-Sided|90.0|0.05|1.48|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR remitters at Week 1.|
1743008|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|3.27||||0.0001|2-Sided|90.0|1.99|5.36|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 10.|
1743009|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.53||||0.1707|2-Sided|90.0|0.92|2.55|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 10.|
1743010|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|2.37||||0.0029|2-Sided|90.0|1.47|3.8|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 8.|
1743011|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.1||||0.751|2-Sided|90.0|0.67|1.8|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 8.|
1743012|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|3.01||||0.0001|2-Sided|90.0|1.9|4.77|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 6.|
1743013|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|0.94||||0.8351|2-Sided|90.0|0.59|1.5|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 6.|
1743014|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.91||||0.0193|2-Sided|90.0|1.21|3.0|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 5.|
1743015|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.0||||0.987|2-Sided|90.0|0.63|1.59|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 5.|
1743016|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.4||||0.2368|2-Sided|90.0|0.88|2.23|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 4.|
1743017|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|0.49||||0.0214|2-Sided|90.0|0.29|0.82|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 4.|
1743018|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.49||||0.2007|2-Sided|90.0|0.89|2.47|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 3.|
1743019|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|0.68||||0.2474|2-Sided|90.0|0.39|1.18|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 3.|
1743020|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.5||||0.2897|2-Sided|90.0|0.8|2.79|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 2.|
1743246|NCT00419159|3206251|Other||Odds Ratio (OR)|0.382||||0.07|2-Sided|95.0|0.135|1.083|||Unadjusted Logistic Regression||||
1743021|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.07||||0.8664|2-Sided|90.0|0.56|2.04|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 2.|
1743022|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|1.23||||0.6886|2-Sided|90.0|0.52|2.93|||Generalized estimating equation model|||Placebo versus Paroxetine in IDS-CR responders at Week 1.|
1743023|NCT00420641|3205930|Superiority or Other||Odds Ratio (OR)|0.65||||0.5072|2-Sided|90.0|0.22|1.89|||Generalized estimating equation model|||Placebo versus GSK372475 in IDS-CR responders at Week 1.|
1743024|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|2.48||||0.0022|2-Sided|90.0|1.52|4.05|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 10.|
1743025|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.95||||0.8826|2-Sided|90.0|0.56|1.61|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 10.|
1743026|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|1.89||||0.0298|2-Sided|90.0|1.17|3.06|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 8.|
1743027|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.76||||0.3961|2-Sided|90.0|0.45|1.29|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 8.|
1743028|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|2.36||||0.0027|2-Sided|90.0|1.47|3.79|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 6.|
1743029|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.86||||0.6327|2-Sided|90.0|0.52|1.43|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 6.|
1743030|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|2.58||||0.004||90.0|1.5|4.42|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 5.|
1743031|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.98||||0.9553|2-Sided|90.0|0.55|1.74|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 5.|
1743032|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|1.15||||0.6647|2-Sided|90.0|0.67|1.98|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 4.|
1743033|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.36||||0.0067|2-Sided|90.0|0.2|0.67|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 4.|
1743034|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|1.07||||0.8558|2-Sided|90.0|0.58|1.98|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 3.|
1743035|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.5||||0.0835|2-Sided|90.0|0.26|0.97|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 3.|
1743036|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|1.93||||0.1786|2-Sided|90.0|0.86|4.32|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 2.|
1743037|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.9||||0.8355|2-Sided|90.0|0.39|2.07|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 2.|
1743038|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|1.29||||0.7425|2-Sided|90.0|0.36|4.68|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS remitters at Week 1.|
1743039|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.89||||0.8844|2-Sided|90.0|0.23|3.48|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS remitters at Week 1.|
1743040|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|3.48||||0|2-Sided|90.0|2.11|5.73|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 10.|
1743041|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|1.15||||0.653|2-Sided|90.0|0.69|1.93|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 10.|
1743042|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|3.24||||0|2-Sided|90.0|2.01|5.23|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 8.|
1743043|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.98||||0.9596|2-Sided|90.0|0.59|1.64|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 8.|
1743044|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|2.71||||0.0002|2-Sided|90.0|1.74|4.21|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 6.|
1743045|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.66||||0.14|2-Sided|90.0|0.41|1.05|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 6.|
1743046|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|1.73||||0.0461|2-Sided|90.0|1.1|2.73|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 5.|
1743047|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.65||||0.1399|2-Sided|90.0|0.4|1.05|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 5.|
1743048|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|1.23||||0.4606|2-Sided|90.0|0.78|1.94|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 4.|
1743049|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.31||||0.0002|2-Sided|90.0|0.18|0.52|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 4.|
1743050|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|1.08||||0.8087|2-Sided|90.0|0.64|1.83|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 3.|
1743051|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.41||||0.0086|2-Sided|90.0|0.23|0.72|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 3.|
1743052|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|1.56||||0.2908|2-Sided|90.0|0.78|3.13|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 2.|
1743053|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|1.04||||0.9209|2-Sided|90.0|0.52|2.08|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 2.|
1743247|NCT00419159|3206252|Other||Odds Ratio (OR)|1.8||||0.253|2-Sided|95.0|0.657|4.929|||Unadjusted Logistic Regression||||
1743054|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|1.22||||0.7398|2-Sided|90.0|0.46|3.25|||Generalized estimating equation model|||Placebo versus Paroxetine in MADRS responders at Week 1.|
1743055|NCT00420641|3205931|Superiority or Other||Odds Ratio (OR)|0.64||||0.5061|2-Sided|90.0|0.21|1.93|||Generalized estimating equation model|||Placebo versus GSK372475 in MADRS responders at Week 1.|
1743056|NCT00420641|3205935|Superiority or Other||Mean Difference (Final Values)|0.06||||0.957|2-Sided|90.0|-1.69|1.81|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in CSFQ-14SF total score at Week 10.|
1743057|NCT00420641|3205935|Superiority or Other||Mean Difference (Final Values)|1.72||||0.126|2-Sided|90.0|-0.13|3.57|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in CSFQ-14SF total score at Week 10.|
1743058|NCT00420641|3205936|Superiority or Other||Mean Difference (Final Values)|6.22||||0.016|2-Sided|90.0|1.97|10.48|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MEI total score at Week 10.|
1743059|NCT00420641|3205936|Superiority or Other||Mean Difference (Final Values)|1.76||||0.516|2-Sided|90.0|-2.71|6.24|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MEI total score at Week 10.|
1743060|NCT00420641|3205937|Superiority or Other||Mean Difference (Final Values)|-0.52||||0|2-Sided|90.0|-0.76|-0.28|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in CGI-S score at Week 10.|
1743061|NCT00420641|3205937|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.208|2-Sided|90.0|-0.45|0.06|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in CGI-S score at Week 10.|
1743062|NCT00420641|3205938|Superiority or Other||Mean Difference (Final Values)|-1.77||||0.001|2-Sided|90.0|-2.64|-0.9|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-SR 5 Item subscale total score at Week 10.|
1743063|NCT00420641|3205938|Superiority or Other||Mean Difference (Final Values)|-0.99||||0.082|2-Sided|90.0|-1.92|-0.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-SR 5 Item subscale total score at Week 10.|
1743064|NCT00420641|3205938|Superiority or Other||Mean Difference (Final Values)|-1.15||||0.003|2-Sided|90.0|-1.79|-0.5|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR 5 Item subscale total score at Week 10.|
1743065|NCT00420641|3205938|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.175|2-Sided|90.0|-1.23|0.12|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR 5 Item subscale total score at Week 10.|
1743066|NCT00420641|3205939|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.002|2-Sided|90.0|-0.6|-0.19|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in HAMD-17 Item 1 score at Week 10.|
1743067|NCT00420641|3205939|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.209|2-Sided|90.0|-0.38|0.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in HAMD-17 Item 1 score at Week 10.|
1743068|NCT00420641|3205940|Superiority or Other||Mean Difference (Final Values)|-2.96||||0|2-Sided|90.0|-4.28|-1.64|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in HAMD-17 total score at Week 10.|
1743069|NCT00420641|3205940|Superiority or Other||Mean Difference (Final Values)|-0.47||||0.576|2-Sided|90.0|-1.84|0.91|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in HAMD-17 total score at Week 10.|
1743070|NCT00420641|3205941|Superiority or Other||Mean Difference (Final Values)|-0.37||||0|2-Sided|90.0|-0.53|-0.22|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR Item 5 at Week 10.|
1743071|NCT00420641|3205941|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.096|2-Sided|90.0|-0.33|0.0|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR Item 5 score at Week 10.|
1743072|NCT00420641|3205942|Superiority or Other||Mean Difference (Final Values)|-0.51||||0.001|2-Sided|90.0|-0.77|-0.25|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS Item 2 score at Week 10.|
1743073|NCT00420641|3205942|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.257|2-Sided|90.0|-0.46|0.09|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MADRS Item 2 score at Week 10.|
1743074|NCT00420641|3205943|Superiority or Other||Mean Difference (Final Values)|-2.12||||0.002|2-Sided|90.0|-3.27|-0.97|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in QIDS-SR16 total score at Week 10.|
1743075|NCT00420641|3205943|Superiority or Other||Mean Difference (Final Values)|-1.03||||0.168|2-Sided|90.0|-2.27|0.2|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in QIDS-SR16 total score at Week 10.|
1743076|NCT00420641|3205944|Superiority or Other||Mean Difference (Final Values)|-1.71||||0.002|2-Sided|90.0|-2.62|-0.81|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in QIDS-CR16 total score at Week 10.|
1743077|NCT00420641|3205944|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.352|2-Sided|90.0|-1.47|0.41|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in QIDS-CR16 total score at Week 10.|
1743078|NCT00420641|3205945|Superiority or Other||Mean Difference (Final Values)|-6.23||||0.001|2-Sided|90.0|-9.21|-3.25|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-SR total score at Week 10.|
1743205|NCT00420095|3206101|Superiority or Other||Mean Difference (Net)|-0.03||||0.67||95.0|-0.16|0.11||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means|||
1743079|NCT00420641|3205945|Superiority or Other||Mean Difference (Final Values)|-2.05||||0.287|2-Sided|90.0|-5.23|1.12|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-SR total score at Week 10.|
1743080|NCT00420641|3205946|Superiority or Other||Mean Difference (Final Values)|-5.12||||0.001|2-Sided|90.0|-7.55|-2.68|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in IDS-CR total score at Week 10.|
1743081|NCT00420641|3205946|Superiority or Other||Mean Difference (Final Values)|-1.66||||0.279|2-Sided|90.0|-4.19|0.87|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in IDS-CR total score at Week 10.|
1743082|NCT00420641|3205947|Superiority or Other||Mean Difference (Final Values)|-1.77||||0|2-Sided|90.0|-2.49|-1.05|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS total score at Week 10.|
1743083|NCT00420641|3205947|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.252|2-Sided|90.0|-1.28|0.23|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in Bech score at Week 10.|
1743084|NCT00420641|3205948|Superiority or Other||Mean Difference (Final Values)|-3.99||||0|2-Sided|90.0|-5.75|-2.22|||MMRM||The point estimate was calculated as LS mean difference (final value) of placebo and Paroxetine.|Placebo versus Paroxetine in MADRS total score at Week 10.|
1743085|NCT00420641|3205948|Superiority or Other||Mean Difference (Final Values)|-0.78||||0.485|2-Sided|90.0|-2.6|1.05|||Mixed Model Repeated Measures (MMRM)||The point estimate was calculated as least square (LS) mean difference (final value) of placebo and GSK372475.|Placebo versus GSK372475 in MADRS total score at Week 10.|
1743086|NCT00420420|3205969|Superiority or Other|||||||0.716||||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at Week 4|
1743087|NCT00420420|3205970|Superiority or Other|||||||0.18||||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at week 4|
1743088|NCT00420420|3205971|Superiority or Other|||||||0.283||||||A longitudinal mixed model was used to compare groups, including factors for week, strata (MMSE score and concomitant AD therapy), treatment, and week-by-treatment interaction.|Mixed Models Analysis|||comparison at Week 4|
1743089|NCT00420342|3205984|Superiority or Other|||||||0.5777||||||0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.|
1743090|NCT00420342|3205984|Superiority or Other|||||||0.198||||||2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.|
1743091|NCT00420342|3205984|Superiority or Other|||||||0.0702||||||0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.|
1743092|NCT00420342|3205985|Superiority or Other|||||||0.6929||||||0.5 mg DRSP / 1.0 mg E2 vs 2.0 mg DRSP / 1.0 mg E2.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.|
1743093|NCT00420342|3205985|Superiority or Other|||||||0.2224||||||2.0 mg DRSP / 1.0 mg E2 vs 1.5mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.|
1743094|NCT00420342|3205985|Superiority or Other|||||||0.1182||||||0.5 mg DRSP / 1.0 mg E2 vs 1.5 mg MPA / 0.3 mg CEE.|ANCOVA|No adjustments made for multiple comparisons||Pairwise comparisons among all three treatment groups were performed; both DRSP / E2 group vs MPA /CEE, and the two active doses against each other. Null hypotheses were that there were no differences between groups for each of the three pairwise comparison. Analysis of variance model was used, with terms for treatment, center, and baseline BP values.|
1743095|NCT00420316|3205988|Superiority or Other||Percent reduction|-23.2||||0.817|2-Sided|95.0|-287.7|54.8|||Fisher Exact|||Vaccine efficacy with respect to severe gastroenteritis (GE) was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.|
1743096|NCT00420316|3205989|Superiority or Other||Percent reduction|0.0||||1|2-Sided|95.0|0.0|98.7|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.|
1743097|NCT00420316|3205990|Superiority or Other||Percent reduction|-97.2||||1|2-Sided|95.0|-9610.8|80.5|||Fisher Exact|||Vaccine efficacy with respect to any rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of non-G1 serotype. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.|
1743098|NCT00420316|3205991|Superiority or Other||Percent reduction|100.0||||0.33|2-Sided|95.0|-1822.5|100.0|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the wild-type rotavirus strain of serotype G1. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.|
1743099|NCT00420316|3205993|Superiority or Other||Percent reduction|50.7||||0.551|2-Sided|95.0|-3769.6|99.4|||Fisher Exact|||Vaccine efficacy with respect to severe rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who have received placebo.|
1743100|NCT00420316|3205994|Superiority or Other||Percent reduction|34.3||||0.691|2-Sided|95.0|-348.7|88.9|||Fisher Exact|||Vaccine efficacy with respect to any rotavirus gastroenteritis (RV GE) caused by the circulating wild-type rotavirus strain. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.|
1743101|NCT00420303|3205995|Superiority or Other|||||||0.007|||||||ANCOVA|Treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|||
1743102|NCT00420303|3205996|Superiority or Other||Odds Ratio (OR)|10.0||||0.02||95.0|1.44|69.26|||Generalized estimating equations (GEE)|Logit link, a binomial distribution and an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors.|||
1743103|NCT00420303|3205997|Superiority or Other||Mean Difference (Final Values)|-17.47||||0.029||95.0|-32.93|-2.01|||ANCOVA|Treatment groups as fixed factors, baseline value as covariate||Comparison of adjusted means|
1743104|NCT00420290|3205998|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1743105|NCT00420290|3205999|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1743106|NCT00420290|3206000|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1743107|NCT00420290|3206001|Superiority or Other|||||||0.03|||||||ANCOVA||||
1743108|NCT00420290|3206002|Superiority or Other|||||||0.008||||||0.031 is the upper level of significance|ANCOVA|||Using data from 128 CHD patients, CRP data were highly skewed, and data were log transformed to achieve normality. With 14 pts in each group (total of 28), it was predicted the minimum detectable difference between control and intervention would be 15% (1.22 for control group and 1.00 for the intervention group), with an 80% power and an alpha of 0.05 using t test approach. Thus, planned sample size was 30 to complete the study.|
1743109|NCT00420238|3206004|Superiority or Other||Odds Ratio (OR)|2.88||||0.025||95.0|1.14|7.27|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.|
1743110|NCT00420238|3206004|Superiority or Other||Odds Ratio (OR)|6.26|||<|0.001||95.0|2.27|17.31|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.|
1743111|NCT00420238|3206004|Superiority or Other||Odds Ratio (OR)|2.46|||<|0.054||95.0|0.99|6.12|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.|
1743112|NCT00420238|3206004|Superiority or Other||Odds Ratio (OR)|4.57|||<|0.004|2-Sided|95.0|1.64|12.74|||GEE model||Odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.|
1743113|NCT00420238|3206006|Superiority or Other||Odds Ratio (OR)|2.38||||0.065||95.0|0.95|5.96|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.|
1743114|NCT00420238|3206006|Superiority or Other||Odds Ratio (OR)|4.96||||0.001||95.0|1.89|13.03|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.|
1743115|NCT00420238|3206006|Superiority or Other||Odds Ratio (OR)|2.62||||0.036||95.0|1.06|6.46|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.|
1743116|NCT00420238|3206006|Superiority or Other||Odds Ratio (OR)|1.87||||0.184|2-Sided|95.0|0.74|4.7|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equation (GEE) model, using a logit link, binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors.|
1743117|NCT00420238|3206009|Superiority or Other||Mean Difference (Final Values)|-14.41|||<|0.0001||95.0|-20.63|-8.19|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.|
1743118|NCT00420238|3206009|Superiority or Other||Mean Difference (Final Values)|-15.19|||<|0.0001||95.0|-21.41|-8.96|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.|
1743119|NCT00420238|3206009|Superiority or Other||Mean Difference (Final Values)|-14.98|||<|0.0001||95.0|-21.2|-8.76|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.|
1743120|NCT00420238|3206009|Superiority or Other||Mean Difference (Final Values)|-14.32|||<|0.0001|2-Sided|95.0|-20.55|-8.1|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors, baseline as a covariate and patients as a random factor.|
1743121|NCT00420238|3206010|Superiority or Other||Mean Difference (Final Values)|-13.24|||<|0.0001|2-Sided|95.0|-18.23|-8.25|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA), with treatment as a factor and baseline value as a covariate.|
1743122|NCT00420238|3206012|Superiority or Other||Mean Difference (Final Values)|-18.16|||<|0.0001||95.0|-23.96|-12.36|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743123|NCT00420238|3206012|Superiority or Other||Mean Difference (Final Values)|-16.95|||<|0.0001||95.0|-22.75|-11.15|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743124|NCT00420238|3206012|Superiority or Other||Mean Difference (Final Values)|-17.45|||<|0.0001||95.0|-23.25|-11.65|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743125|NCT00420238|3206012|Superiority or Other||Mean Difference (Final Values)|-12.37|||<|0.0001|2-Sided|95.0|-18.17|-6.58|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and atients as a random factor.|
1743126|NCT00420238|3206013|Superiority or Other||Mean Difference (Final Values)|-14.73|||<|0.0001|2-Sided|95.0|-19.44|-10.03|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA)with treatment as a factor and baseline vlue as a covariate.|
1743127|NCT00420238|3206015|Superiority or Other||Mean Difference (Final Values)|-4.02||||0.562||95.0|-17.81|9.77|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743128|NCT00420238|3206015|Superiority or Other||Mean Difference (Final Values)|-1.39||||0.84||95.0|-15.12|12.34|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743129|NCT00420238|3206015|Superiority or Other||Mean Difference (Final Values)|-3.09||||0.651||95.0|-16.73|10.54|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743130|NCT00420238|3206015|Superiority or Other||Mean Difference (Final Values)|-4.72||||0.49|2-Sided|95.0|-18.35|8.91|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743131|NCT00420238|3206017|Superiority or Other||Mean Difference (Final Values)|0.06||||0.76||95.0|-0.34|0.46|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743132|NCT00420238|3206017|Superiority or Other||Mean Difference (Final Values)|0.2||||0.325||95.0|-0.2|0.6|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743133|NCT00420238|3206017|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.625||95.0|-0.5|0.3|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743134|NCT00420238|3206017|Superiority or Other||Mean Difference (Final Values)|0.07||||0.744|2-Sided|95.0|-0.34|0.47|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743135|NCT00420238|3206018|Superiority or Other||Mean Difference (Final Values)|0.07||||0.613|2-Sided|95.0|-0.22|0.37|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.|
1743136|NCT00420238|3206030|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.011||95.0|-0.65|-0.08|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743206|NCT00420095|3206103|Superiority or Other|||||||0.672||||||P-value for the HbA1c Percentage Criteria (6.5%)|Fisher Exact||||
1743137|NCT00420238|3206030|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.008||95.0|-0.67|-0.1|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743138|NCT00420238|3206030|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.316||95.0|-0.43|0.14|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743139|NCT00420238|3206030|Superiority or Other||Mean Difference (Final Values)|-0.09||||0.515|2-Sided|95.0|-0.38|0.19|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Mixed model analysis of covariance (ANCOVA), using an auto-regressive correlation structure, with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate and patients as a random factor.|
1743140|NCT00420238|3206031|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.035|2-Sided|95.0|-0.45|-0.02|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as covariate.|
1743141|NCT00420238|3206032|Superiority or Other||Mean Difference (Final Values)|-2.59||||0.03|2-Sided|95.0|-4.93|-0.26|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis oaf covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.|
1743142|NCT00420238|3206033|Superiority or Other||Mean Difference (Final Values)|0.06||||0.205|2-Sided|95.0|-0.04|0.17|||ANCOVA||Least squares mean difference = mean difference final value.|Forced Expitatory Volume in 1 second: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.|
1743143|NCT00420238|3206033|Superiority or Other||Mean Difference (Final Values)|0.18||||0.006|2-Sided|95.0|0.05|0.31|||ANCOVA||Least squares mean difference = mean difference final value.|Forced Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.|
1743144|NCT00420238|3206033|Superiority or Other||Mean Difference (Final Values)|0.19||||0.003|2-Sided|95.0|0.06|0.31|||ANCOVA||Least squares mean difference = mean difference final value.|Vital Capacity: Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.|
1743145|NCT00420238|3206036|Superiority or Other||Mean Difference (Final Values)|-13.65||||0.007||95.0|-23.43|-3.88|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743146|NCT00420238|3206036|Superiority or Other||Mean Difference (Final Values)|-9.9||||0.047||95.0|-19.68|-0.13|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743147|NCT00420238|3206036|Superiority or Other||Mean Difference (Final Values)|-5.1||||0.304||95.0|-14.88|4.67|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743148|NCT00420238|3206036|Superiority or Other||Mean Difference (Final Values)|0.89||||0.857|2-Sided|95.0|-8.88|10.67|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743149|NCT00420238|3206037|Superiority or Other||Mean Difference (Final Values)|-5.94||||0.139|2-Sided|95.0|-13.84|1.96|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.|
1743150|NCT00420238|3206041|Superiority or Other||Mean Difference (Final Values)|-11.95||||0.008||95.0|-20.66|-3.24|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743151|NCT00420238|3206041|Superiority or Other||Mean Difference (Final Values)|-12.55||||0.005||95.0|-21.26|-3.84|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743152|NCT00420238|3206041|Superiority or Other||Mean Difference (Final Values)|-6.45||||0.145||95.0|-15.16|2.26|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743153|NCT00420238|3206041|Superiority or Other||Mean Difference (Final Values)|-6.86||||0.122|2-Sided|95.0|-15.57|1.85|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743154|NCT00420238|3206044|Superiority or Other||Mean Difference (Final Values)|-11.54||||0.004||95.0|-19.35|-3.73|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743207|NCT00420095|3206103|Superiority or Other|||||||0.644||||||P-value for the HbA1c Percentage Criteria (7%)|Fisher Exact||||
1744076|NCT00408876|3207607|Superiority or Other|||||||0.225|||||||Repeated Measures||||
1743155|NCT00420238|3206044|Superiority or Other||Mean Difference (Final Values)|-8.21||||0.039||95.0|-16.02|-0.4|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743156|NCT00420238|3206044|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.544||95.0|-10.21|5.41|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743157|NCT00420238|3206044|Superiority or Other||Mean Difference (Final Values)|-0.43||||0.914|2-Sided|95.0|-8.23|7.38|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743158|NCT00420238|3206045|Superiority or Other||Mean Difference (Final Values)|-5.25||||0.127|2-Sided|95.0|-12.03|1.53|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline as a covariate.|
1743159|NCT00420238|3206047|Superiority or Other||Mean Difference (Final Values)|-14.25||||0.01||95.0|-24.99|-3.51|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743160|NCT00420238|3206047|Superiority or Other||Mean Difference (Final Values)|-12.45||||0.023||95.0|-23.19|-1.71|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743161|NCT00420238|3206047|Superiority or Other||Mean Difference (Final Values)|-4.57||||0.401||95.0|-15.31|6.17|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743162|NCT00420238|3206047|Superiority or Other||Mean Difference (Final Values)|-3.57||||0.511|2-Sided|95.0|-14.31|7.17|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743163|NCT00420238|3206048|Superiority or Other||Mean Difference (Final Values)|-8.49||||0.071|2-Sided|95.0|-17.73|0.75|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.|
1743164|NCT00420238|3206050|Superiority or Other||Mean Difference (Final Values)|-19.69|||<|0.001||95.0|-30.54|-8.84|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743165|NCT00420238|3206050|Superiority or Other||Mean Difference (Final Values)|-13.72|||<|0.014||95.0|-24.57|-2.88|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743166|NCT00420238|3206050|Superiority or Other||Mean Difference (Final Values)|-5.17|||<|0.348||95.0|-16.02|5.68|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743167|NCT00420238|3206050|Superiority or Other||Mean Difference (Final Values)|-6.28|||<|0.254|2-Sided|95.0|-17.13|4.57|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743168|NCT00420238|3206051|Superiority or Other||Mean Difference (Final Values)|-9.59||||0.039|2-Sided|95.0|-18.69|-0.49|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.|
1743169|NCT00420238|3206053|Superiority or Other||Mean Difference (Final Values)|-15.29|||<|0.001||95.0|-23.7|-6.82|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743170|NCT00420238|3206053|Superiority or Other||Mean Difference (Final Values)|-12.75|||<|0.003||95.0|-21.23|-4.27|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743171|NCT00420238|3206053|Superiority or Other||Mean Difference (Final Values)|-11.02|||<|0.011||95.0|-19.5|-2.54|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743245|NCT00419159|3206250|Other||Hazard Ratio (HR)|0.814||||0.399|2-Sided|95.0|0.505|1.312|||Unadjusted Logistic Regression||||
1743172|NCT00420238|3206053|Superiority or Other||Mean Difference (Final Values)|-8.33|||<|0.054|2-Sided|95.0|-16.81|0.15|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743173|NCT00420238|3206054|Superiority or Other||Mean Difference (Final Values)|-10.99||||0.002|2-Sided|95.0|-17.7|-4.28|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.|
1743174|NCT00420238|3206056|Superiority or Other||Mean Difference (Final Values)|-9.27||||0.065||95.0|-19.14|0.59|||ANCOVA||Least squares mean difference = mean difference final value.|Week 12: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743175|NCT00420238|3206056|Superiority or Other||Mean Difference (Final Values)|-14.73||||0.004||95.0|-24.6|-4.86|||ANCOVA||Least squares mean difference = mean difference final value.|Week 8: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743176|NCT00420238|3206056|Superiority or Other||Mean Difference (Final Values)|-8.02||||0.11||95.0|-17.89|1.85|||ANCOVA||Least squares mean difference = mean difference final value.|Week 4: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interactions as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743177|NCT00420238|3206056|Superiority or Other||Mean Difference (Final Values)|-8.54||||0.089|2-Sided|95.0|-18.4|1.33|||ANCOVA||Least squares mean difference = mean difference final value.|Week 2: Comparison of leasts squares means. Mixed-model analysis of covariance (ANCOVA) using an auto-regressive correlation structure with treatment groups, visits and their interaction as fixed factors, baseline value as a covariate, and patients as a random factor.|
1743178|NCT00420238|3206057|Superiority or Other||Mean Difference (Final Values)|-9.95||||0.018|2-Sided|95.0|-18.19|-1.72|||ANCOVA||Least squares mean difference = mean difference final value.|Analysis of covariance (ANCOVA) with treatment as a factor and baseline value as a covariate.|
1743179|NCT00420238|3206059|Superiority or Other||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743180|NCT00420238|3206059|Superiority or Other||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743181|NCT00420238|3206059|Superiority or Other||Odds Ratio (OR)|4.8||||0.169||95.0|0.51|44.94|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743182|NCT00420238|3206059|Superiority or Other||Odds Ratio (OR)|3.5||||0.287|2-Sided|95.0|0.35|35.14|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743183|NCT00420238|3206061|Superiority or Other||Odds Ratio (OR)|3.36||||0.058||95.0|0.96|11.8|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743184|NCT00420238|3206061|Superiority or Other||Odds Ratio (OR)|3.73||||0.121||95.0|0.71|19.69|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743185|NCT00420238|3206061|Superiority or Other||Odds Ratio (OR)|4.48||||0.073||95.0|0.87|23.07|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743186|NCT00420238|3206061|Superiority or Other||Odds Ratio (OR)|3.01||||0.204|2-Sided|95.0|0.55|16.53|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743187|NCT00420238|3206063|Superiority or Other||Odds Ratio (OR)|3.85||||0.014||95.0|1.31|11.32|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743188|NCT00420238|3206063|Superiority or Other||Odds Ratio (OR)|2.88||||0.046||95.0|1.02|8.16|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1744077|NCT00408876|3207607|Superiority or Other|||||||0.013|||||||Repeated Measures||||
1743189|NCT00420238|3206063|Superiority or Other||Odds Ratio (OR)|1.54||||0.44||95.0|0.51|4.64|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743190|NCT00420238|3206063|Superiority or Other||Odds Ratio (OR)|2.13||||0.259|2-Sided|95.0|0.57|7.94|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in etanercept group than in placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743191|NCT00420238|3206065|Superiority or Other||Odds Ratio (OR)|4.14||||0.003||95.0|1.65|10.42|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743192|NCT00420238|3206065|Superiority or Other||Odds Ratio (OR)|4.61||||0.001|2-Sided|95.0|1.81|11.74|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743193|NCT00420238|3206065|Superiority or Other||Odds Ratio (OR)|1.61||||0.309|2-Sided|95.0|0.65|3.99|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743194|NCT00420238|3206065|Superiority or Other||Odds Ratio (OR)|1.68||||0.31|2-Sided|95.0|0.62|4.57|||GEE model||An odds ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, and their interaction as fixed factors.|
1743195|NCT00420238|3206066|Superiority or Other||Odds Ratio (OR)|2.83||||0.031|2-Sided|95.0|1.1|7.29|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 12: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.|
1743196|NCT00420238|3206066|Superiority or Other||Odds Ratio (OR)|2.3||||0.087|2-Sided|95.0|0.89|5.95|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 8: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.|
1743197|NCT00420238|3206066|Superiority or Other||Odds Ratio (OR)|2.02||||0.197|2-Sided|95.0|0.69|5.88|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 4: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.|
1743198|NCT00420238|3206066|Superiority or Other||Odds Ratio (OR)|2.92||||0.098|2-Sided|95.0|0.82|10.42|||GEE model||An odds-ratio greater than 1 indicates the odds of response is greater in the etanercept group than in the placebo group.|Week 2: Generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits and their interactions as fixed factors.|
1743199|NCT00420238|3206067|Superiority or Other||Mean Difference (Final Values)|-8.83||||0.019|2-Sided|95.0|-16.5|-1.51|||ANCOVA||Least squares mean difference = mean difference final value.|Comparison of least squares means. Primary analysis: analysis of covariance (ANCOVA) with treatment as a factor and BASDAI baseline as a covariate.|
1743200|NCT00420199|3206076|Superiority or Other||Mean Difference (Net)|0.69||||0.078||95.0|||||ANCOVA|||Comparison in change from baseline of wrist synovitis using OMERACT 6 rheumatoid arthritis magnetic resonance imaging (MRI) score method between ABA and PLA at Day 113 based on a parametric analysis of covariance model (ANCOVA). The model included the score change from baseline as the dependent variable, treatment group as a main effect and baseline score as an additional covariate.|
1743201|NCT00420199|3206090|Superiority or Other||Adjusted Mean Difference from Placebo|-4.71|||||2-Sided|95.0|-8.0|-1.42||||||Comparison in the change from baseline of RAMRIS score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.|
1743202|NCT00420199|3206093|Superiority or Other||Adjusted Mean Difference from Placebo|-3.48|||||2-Sided|95.0|-6.0|-0.96||||||Comparison in the change from baseline of Edema/Osteitis score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.|
1743203|NCT00420199|3206095|Superiority or Other||Mean Difference (Final Values)|0.96||||0.103||95.0|||||ANCOVA|||Comparison in change from baseline of wrist synovitis using OMERACT 6 rheumatoid arthritis magnetic resonance imaging score method between abatacept and placebo at Day 113 based on a nonparametric analysis of covariance model. Baseline and changes from baseline of the total wrist synovitis scores were ranked, and the model included the rank score for change from baseline as the dependent variable with treatment group as a main effect and the rank score for baseline as an additional covariate.|
1743204|NCT00420199|3206096|Superiority or Other||Adjusted Mean Difference from Placebo|-0.5|||||2-Sided|95.0|-1.77|0.76||||||Comparison in the change from baseline of erosion score using the OMERACT 6 RA MRI score method between Abatacept and Placebo at Day 113 was based on a non-parametric analysis of covariance model (ANCOVA). Change from BL = Post-BL measurement-BL value. Adjustment was based on ANCOVA model with treatment as a factor and BL value a covariate.|
1743208|NCT00420095|3206104|Superiority or Other||Mean Difference (Net)|-0.16||||0.741||95.0|-1.09|0.78||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means|||
1743209|NCT00420095|3206105|Superiority or Other||Mean Difference (Net)|-0.14||||0.419||95.0|-0.48|0.2||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means|||
1743210|NCT00420095|3206106|Superiority or Other||Mean Difference (Net)|0.05||||0.497||95.0|-0.1|0.2||All comparisons were conducted using a 2-sided significance level of 0.05.|Mixed Models Analysis|Adjusted means|||
1743211|NCT00420095|3206107|Non-Inferiority or Equivalence|"Non-inferiority hypothesis testing where paired t-test for equivalence of means was used to estimate the sample size.~Pre-defined non-inferiority margin of 0.3%."|Mean Difference (Net)|-0.05||||0.497||95.0|-0.2|0.1|||Mixed Models Analysis|The Kenward-Roger approximation was used to estimate the denominator degrees of freedom. Adjusted means were presented.||Mixed model where period, sequence, treatment are fixed effects and patient within sequence are random effects.|
1743212|NCT00420056|3206108|Superiority or Other|||||||0.4921|||||||Regression, Linear|||Concentration versus FDG-PET SUVmax|
1743213|NCT00420056|3206108|Superiority or Other|||||||0.28|||||||Regression, Linear|||Concentration versus FLT-PET SUVmax|
1743214|NCT00420056|3206108|Superiority or Other|||||||0.0956|||||||Regression, Linear|||Concentration versus phospho-Rb|
1743215|NCT00420056|3206108|Superiority or Other|||||||0.1286|||||||Regression, Linear|||Concentration versus Cyclin D1|
1743216|NCT00420056|3206108|Superiority or Other|||||||0.5954|||||||Regression, Linear|||Concentration versus Ki-67|
1743217|NCT00420056|3206122|Superiority or Other||Kappa|0.1864|||||2-Sided|95.0|-0.2316|0.6045||||||FDG-PET response versus Objective response|
1743218|NCT00420056|3206122|Superiority or Other||Kappa|0.0638|||||2-Sided|95.0|-0.0449|0.1726||||||FLT-PET response versus Objective response|
1743219|NCT00420056|3206125|Superiority or Other|||||||0.709|||||||Regression, Linear||||
1743220|NCT00420056|3206126|Superiority or Other|||||||0.4854|||||||Regression, Linear||||
1743221|NCT00420017|3206127|Superiority or Other|||||||0.66|||||||Chi-squared||||
1743222|NCT00420017|3206128|Superiority or Other|||||||0.097|||||||Wilcoxon (Mann-Whitney)||||
1743223|NCT00420017|3206129|Superiority or Other|||||||0.31|||||||Wilcoxon (Mann-Whitney)||||
1743224|NCT00420017|3206130|Superiority or Other||Risk Ratio (RR)|0.38||||0.02|2-Sided|95.0|0.16|0.86|||Chi-squared||||
1743225|NCT00420004|3206149|Superiority or Other|||||||0.494|||||||Mixed Models Analysis||||
1743226|NCT00419380|3206217|Superiority or Other|||||||0.26||||||Two by two contingency table was used to compare our outcome, presence/absence of ear drainage, by our two independent variables, dornase alfa (Pulmozyme®) and Ofloxin.|Chi-squared||||
1743227|NCT00419380|3206218|Superiority or Other|||||||0.36|||||||Chi-squared|||Two by two contingency table was used to compare our outcome, tube patency yes/no, by our two independent variables, dornase alfa (Pulmozyme®) and Ofloxin.|
1743228|NCT00419341|3206234|Non-Inferiority or Equivalence|Non-inferiority of SCIG:IVIG treatment was concluded if the lower GMR confidence limit was 0.8 or more. With 18 evaluable subjects, the power to show this non-inferiority was calculated to be 85% based on the assumptions of an intra-individual variability with a coefficient of variation (CV) = 25% and a GMR equal to or greater than 1.|Geometric mean ratio (GMR)|1.002|||||2-Sided|90.0|0.951|1.055|||||Geometric mean ratio SCIG:IVIG non-inferiority was concluded if the lower GMR confidence limit was 0.8 or more|Individual sAUC values (standardized to a 7-day period) of the IV and adjusted SC sampling periods in each individual subject were log transformed and a parametric 2-sided 90% confidence interval (CI) for the mean of the individual differences was obtained. Back-transformation of the mean and its CI produced the geometric mean ratio (GMR) and its respective 90% CI.|
1743229|NCT00419263|3206238|Superiority or Other|||||||0.327||||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)||||
1743230|NCT00419263|3206239|Superiority or Other|||||||0.409||||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)||||
1743231|NCT00419263|3206240|Superiority or Other||||||<|0.001||||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)||||
1743232|NCT00419263|3206241|Superiority or Other|||||||0.002||||||The differences between the treatment groups were evaluated using a Wilcoxon Rank Sum Test controlling for current smoking behavior.|Wilcoxon (Mann-Whitney)||||
1743233|NCT00419263|3206242|Superiority or Other|||||||0.537||||||P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.|Log Rank||||
1743234|NCT00419263|3206243|Superiority or Other|||||||0.007||||||P-value is based on the log-rank statistic controlling for current smoking behavior and geographic region.|Log Rank||||
1743235|NCT00419263|3206244|Superiority or Other|||||||0.377|||||||Regression, Cox|P-value is based on the treatment parameter from the Cox Regression Model including treatment, current smoking behavior, and geographic region.|||
1743236|NCT00419159|3206245|Other||Hazard Ratio (HR)|0.611||||0.148|2-Sided|95.0|0.314|1.191|||Unadjusted Cox Model||||
1743237|NCT00419159|3206245|Other||Hazard Ratio (HR)|0.868||||0.588|2-Sided|95.0|0.521|1.447|||Unadjusted Cox Model||||
1743238|NCT00419159|3206246|Other||Hazard Ratio, log|1.151||||0.583|2-Sided|95.0|0.696|1.903|||Unadjusted Cox Model||||
1743239|NCT00419159|3206246|Other||Hazard Ratio (HR)|1.474||||0.145|2-Sided|95.0|0.875|2.484|||Unadjusted Cox Model||||
1743240|NCT00419159|3206247|Other||Odds Ratio (OR)|1.044||||0.938|2-Sided|95.0|0.352|3.099|||Unadjusted Logistic Regression||||
1743241|NCT00419159|3206248|Other||Odds Ratio (OR)|0.529||||0.238|2-Sided|95.0|0.184|1.523|||Unadjusted Logistic Regression||||
1743242|NCT00419159|3206249|Other||Hazard Ratio, log|1.547||||0.126|2-Sided|95.0|0.884|2.708|||Unadjusted Logistic Regression||||
1743243|NCT00419159|3206249|Other||Hazard Ratio, log|1.203||||0.441|2-Sided|95.0|0.752|1.923|||Unadjusted Logistic Regression||||
1743244|NCT00419159|3206250|Other||Hazard Ratio, log|1.001||||0.995|2-Sided|95.0|0.62|1.617|||Unadjusted Logistic Regression||||
1743248|NCT00418834|3206291|Superiority or Other||Mean Difference (Final Values)|-7.0||||0.09||95.0|-15.6|1.6|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment|"(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)~Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means."||
1743249|NCT00418834|3206292|Superiority or Other||Mean Difference (Final Values)|-2.8||||0.534||95.0|-11.9|6.4|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, AVD status, and the interaction of time by treatment|"(Atorva 10 mg + EZ minus Atorva 20 mg)~Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means."||
1743250|NCT00418834|3206293|Superiority or Other||Mean Difference (Final Values)|-6.7|Standard Error of the Mean|1.6|<|0.001||95.0|-9.8|-3.6|||ANCOVA|Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)||
1743251|NCT00418834|3206294|Superiority or Other||Mean Difference (Final Values)|-12.9|Standard Error of the Mean|1.2|<|0.001||95.0|-15.3|-10.5|||ANCOVA|Model terms: treatment, baseline non-HDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)||
1743252|NCT00418834|3206295|Superiority or Other||Mean Difference (Final Values)|-5.3|Standard Error of the Mean|1.2|<|0.001||95.0|-7.7|-2.9|||ANCOVA|Model terms: treatment, baseline Apo B:Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)||
1743253|NCT00418834|3206296|Superiority or Other||Mean Difference (Final Values)|-9.5|Standard Error of the Mean|1.0|<|0.001||95.0|-11.6|-7.5|||ANCOVA|Model terms: treatment, baseline Apo B:Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)||
1743254|NCT00418834|3206297|Superiority or Other||Mean Difference (Final Values)|-6.9|Standard Error of the Mean|1.7|<|0.001||95.0|-10.1|-3.7|||ANCOVA|Model terms: treatment, baseline LDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)||
1743255|NCT00418834|3206298|Superiority or Other||Mean Difference (Final Values)|-14.6|Standard Error of the Mean|1.2|<|0.001||95.0|-17.0|-12.2|||ANCOVA|Model terms: treatment, baseline LDL-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)||
1743256|NCT00418834|3206299|Superiority or Other||Mean Difference (Final Values)|-4.6|Standard Error of the Mean|1.1|<|0.001||95.0|-6.8|-2.4|||ANCOVA|Model terms: treatment, baseline Total-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)||
1743257|NCT00418834|3206300|Superiority or Other||Mean Difference (Final Values)|-9.0|Standard Error of the Mean|0.9|<|0.001||95.0|-10.7|-7.3|||ANCOVA|Model terms: treatment, baseline Total-C:HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)||
1743258|NCT00418834|3206301|Superiority or Other||Mean Difference (Final Values)|2.7|Standard Error of the Mean|0.8|<|0.001||95.0|1.1|4.2|||ANCOVA|Model terms: treatment, baseline Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)||
1743259|NCT00418834|3206302|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.8||0.401||95.0|-0.9|2.1|||ANCOVA|Model terms: treatment, baseline Apo A-I, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)||
1743260|NCT00418834|3206303|Superiority or Other||Mean Difference (Final Values)|-3.2|Standard Error of the Mean|1.2|<|0.001||95.0|-5.5|-0.9|||ANCOVA|Model terms: treatment, baseline Apo B, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)||
1743261|NCT00418834|3206304|Superiority or Other||Mean Difference (Final Values)|-9.1|Standard Error of the Mean|0.9|<|0.001||95.0|-11.0|-7.3|||ANCOVA|Model terms: treatment, baseline Apo B, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)||
1743262|NCT00418834|3206305|Superiority or Other||Median Difference (Final Values)|-2.1|||<|0.001||95.0|-5.2|1.0|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status|"(Atorva 10 mg + EZ minus Atorva 20 mg)~The median difference is based on the Hodges-Lehmann estimates~of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic"||
1743263|NCT00418834|3206306|Superiority or Other||Median Difference (Final Values)|-6.2|||<|0.001||95.0|-9.0|-3.4|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline TG value (normalized scores), and AVD status|"(Atorva 10 mg + EZ minus Atorva 20 mg)~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic"||
1743264|NCT00418834|3206307|Superiority or Other||Mean Difference (Final Values)|-2.0|Standard Error of the Mean|0.9|<|0.001||95.0|-3.8|-0.2|||ANCOVA|Model terms: treatment, baseline Total Cholesterol, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)||
1743265|NCT00418834|3206308|Superiority or Other||Mean Difference (Final Values)|-7.9|Standard Error of the Mean|0.7|<|0.001||95.0|-9.4|-6.5|||ANCOVA|Model terms: treatment, baseline Total Cholesterol, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)||
1743266|NCT00418834|3206309|Superiority or Other||Mean Difference (Final Values)|-4.2|Standard Error of the Mean|1.3|<|0.001||95.0|-6.8|-1.7|||ANCOVA|Model terms: treatment, baseline non-HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)||
1743267|NCT00418834|3206310|Superiority or Other||Mean Difference (Final Values)|-12.2|Standard Error of the Mean|1.0|<|0.001||95.0|-14.2|-10.3|||ANCOVA|Model terms: treatment, baseline non-HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)||
1743268|NCT00418834|3206311|Superiority or Other||Mean Difference (Final Values)|3.1|Standard Error of the Mean|0.8|<|0.001||95.0|1.5|4.8|||ANCOVA|Model terms: treatment, baseline HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg / Atorva 40 mg)||
1743269|NCT00418834|3206312|Superiority or Other||Mean Difference (Final Values)|1.9|Standard Error of the Mean|0.8|<|0.001||95.0|0.3|3.5|||ANCOVA|Model terms: treatment, baseline HDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)||
1743270|NCT00418834|3206313|Superiority or Other||Odds Ratio (OR)|1.75|||<|0.001||95.0|1.32|2.31|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg||
1743271|NCT00418834|3206314|Superiority or Other||Odds Ratio (OR)|5.48|||<|0.001||95.0|3.98|7.55|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg||
1743272|NCT00418834|3206315|Superiority or Other||Odds Ratio (OR)|1.87|||<|0.001||95.0|1.4|2.5|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg / Atorva 40 mg||
1743273|NCT00418834|3206316|Superiority or Other||Odds Ratio (OR)|6.32|||<|0.001||95.0|4.52|8.84|||Regression, Logistic|Model terms: treatment, baseline LDL-C, and AVD status|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva 10 mg + EZ versus Atorva 20 mg||
1743274|NCT00418834|3206317|Superiority or Other||Mean Difference (Final Values)|-4.6|Standard Error of the Mean|1.4|<|0.001||95.0|-7.4|-1.8|||ANCOVA|Model terms: treatment, baseline LDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)||
1743275|NCT00418834|3206318|Superiority or Other||Mean Difference (Final Values)|-13.8|Standard Error of the Mean|1.1|<|0.001||95.0|-16.0|-11.7|||ANCOVA|Model terms: treatment, baseline LDL-C, and AVD status|(Atorva 10 mg + EZ minus Atorva 20 mg)||
1743276|NCT00418717|3206320|Superiority or Other||Mean Difference (Net)|-0.1||||||95.0|-0.25|0.06|||||||
1743277|NCT00418665|3206323|Superiority or Other||Odds Ratio (OR)|0.866||||||95.0|0.175|4.278|||||Romiplostim/placebo||
1743278|NCT00418665|3206323|Superiority or Other||Odds Ratio (OR)|0.911||||||95.0|0.097|8.529|||||Romiplostim/placebo||
1743279|NCT00418665|3206324|Superiority or Other||Odds Ratio (OR)|1.714||||||95.0|0.144|20.473|||||Romiplostim/placebo||
1743280|NCT00418665|3206324|Superiority or Other||Odds Ratio (OR)|3.0||||||95.0|0.227|39.608|||||Romiplostim/placebo||
1743281|NCT00418665|3206325|Superiority or Other||Odds Ratio (OR)|0.514||||||95.0|0.102|2.589|||||Romiplostim/placebo||
1743282|NCT00418665|3206325|Superiority or Other||Odds Ratio, log|0.154||||||95.0|0.022|1.071|||||Romiplostim/placebo||
1743283|NCT00418665|3206326|Superiority or Other||Odds Ratio (OR)|0.154||||||95.0|0.022|1.071|||||Romiplostim/placebo||
1743284|NCT00418665|3206326|Superiority or Other||Odds Ratio (OR)|0.6||||||95.0|0.07|5.136|||||Romiplostim/placebo||
1743285|NCT00418574|3206330|Superiority or Other||Hazard Ratio (HR)|1.099||||0.301|2-Sided|95.0|0.919|1.315|||Regression, Cox||||
1743286|NCT00418561|3206347|Superiority or Other|||||||0.1268||||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using ANOVA model including the baseline measurement as a covariate.|
1743287|NCT00418561|3206349|Superiority or Other|||||||0.1115||||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using ANOVA model including the baseline measurement as a covariate.|
1743288|NCT00418561|3206350|Superiority or Other|||||||0.0737||||||Test for no difference between cohorts.|ANOVA|||The comparisons of the three doses were done using analysis of variance (ANOVA) model including the baseline measurement as a covariate.|
1743289|NCT00418522|3206352|Superiority or Other||Mean Difference (Final Values)|-0.27||||0.0062||95.0|-0.47|-0.08|||ANCOVA||The superiority test used a one-sided 2.5% level of significance.|With an established non-inferiority claim, an additional test for superiority was conducted (ie, the margin was 0.0%).|
1743290|NCT00418522|3206352|Non-Inferiority or Equivalence|The non-inferiority test utilized a one-sided 2.5% level of significance.|Mean Difference (Final Values)|-0.27|||<|0.0001||95.0|-0.47|-0.08|||ANCOVA||A CI approach was presented with a two-sided 95% CI of the difference between treatment and control.|The null hypothesis was that the inhaled human insulin group was inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, while the alternate hypothesis is that the inhaled human insulin group was not inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, given the predetermined non-inferiority margin of 0.4%.|
1743291|NCT00418522|3206354|Superiority or Other||Mean Difference (Final Values)|0.42||||0.0053||95.0|0.12|0.71|||ANCOVA||||
1743292|NCT00418522|3206355|Superiority or Other||Mean Difference (Final Values)|1.2||||0.0055||95.0|0.35|2.04|||ANCOVA||||
1743293|NCT00418522|3206361|Superiority or Other||Mean Difference (Final Values)|-18.72||||0.1862||95.0|-51.34|13.89|||ANCOVA||||
1743294|NCT00418522|3206362|Superiority or Other||Mean Difference (Final Values)|58.7||||0.1856||95.0|-43.37|160.77|||ANCOVA||||
1743295|NCT00418522|3206363|Superiority or Other||Mean Difference (Final Values)|0.01||||0.685||95.0|-0.03|0.04|||ANCOVA|||ApoB at Week 26.|
1743296|NCT00418522|3206363|Superiority or Other||Mean Difference (Final Values)|0.36||||0.5005||95.0|-0.69|1.42|||ANCOVA|||Adiponectin at Week 26.|
1743297|NCT00418522|3206364|Superiority or Other||Mean Difference (Final Values)|2.28||||0.7684||95.0|-12.94|17.51|||ANCOVA|||Spot urine microalbumin at Week 26.|
1743298|NCT00418522|3206364|Superiority or Other||Mean Difference (Final Values)|-0.61||||0.6099||95.0|-2.97|1.75|||ANCOVA|||Leptin at Week 26.|
1743299|NCT00418522|3206364|Superiority or Other||Mean Difference (Final Values)|0.24||||0.5673||95.0|-0.58|1.06|||ANCOVA|||hs-CRP at Week 26.|
1743300|NCT00418522|3206365|Superiority or Other||Mean Difference (Final Values)|4.26||||0.5684||95.0|-10.4|18.92|||ANCOVA|||Triglycerides at Week 26.|
1743301|NCT00418522|3206365|Superiority or Other||Mean Difference (Final Values)|3.43||||0.1369||95.0|-1.1|7.96|||ANCOVA|||LDL-c at Week 26.|
1743302|NCT00418522|3206365|Superiority or Other||Mean Difference (Final Values)|2.09||||0.0017||95.0|0.79|3.39|||ANCOVA|||HDL-c at Week 26.|
1743303|NCT00418522|3206365|Superiority or Other||Mean Difference (Final Values)|5.21||||0.0735||95.0|-0.5|10.91|||ANCOVA|||Total Cholesterol at Week 26.|
1743304|NCT00418522|3206366|Superiority or Other||Mean Difference (Final Values)|-33.76|||<|0.0001||95.0|-44.17|-23.35|||ANCOVA|||Post-Dinner, Week 26.|
1743305|NCT00418522|3206366|Superiority or Other||Mean Difference (Final Values)|-29.11|||<|0.0001||95.0|-39.77|-18.44|||ANCOVA|||Post-Lunch, Week 26.|
1743306|NCT00418522|3206366|Superiority or Other||Mean Difference (Final Values)|-9.61|||<|0.1207||95.0|-21.76|2.54|||ANCOVA|||Post-Breakfast, Week 26.|
1743307|NCT00418522|3206367|Superiority or Other||Mean Difference (Final Values)|-2.41||||0.695||95.0|-14.51|9.69|||ANCOVA|||Time 180 at Week 26.|
1743308|NCT00418522|3206367|Superiority or Other||Mean Difference (Final Values)|0.63||||0.9222||95.0|-12.12|13.39|||ANCOVA|||Time 120 at Week 26.|
1743309|NCT00418522|3206367|Superiority or Other||Mean Difference (Final Values)|6.69||||0.3168||95.0|-6.45|19.83|||ANCOVA|||Time 90 at Week 26.|
1743310|NCT00418522|3206367|Superiority or Other||Mean Difference (Final Values)|18.96||||0.0044||95.0|5.96|31.96|||ANCOVA|||Time 60 at Week 26.|
1743311|NCT00418522|3206367|Superiority or Other||Mean Difference (Final Values)|28.57|||<|0.0001||95.0|16.55|40.59|||ANCOVA|||Time 30 at Week 26.|
1743312|NCT00418522|3206367|Superiority or Other||Mean Difference (Final Values)|32.96|||<|0.0001||95.0|22.66|43.25|||ANCOVA|||Time 0 (fasting) at Week 26.|
1743313|NCT00418522|3206368|Superiority or Other||Mean Difference (Final Values)|2.57||||0.6091||95.0|-7.31|12.46|||ANCOVA||||
1743314|NCT00418522|3206369|Superiority or Other||Odds Ratio (OR)|0.71||||0.248||95.0|0.4|1.27|||Regression, Logistic||||
1743315|NCT00418522|3206370|Superiority or Other||Odds Ratio (OR)|2.01||||0.0022||95.0|1.29|3.15|||Regression, Logistic||||
1743316|NCT00418522|3206371|Superiority or Other||Odds Ratio (OR)|1.96||||0.0052||95.0|1.22|3.14|||Regression, Logistic||||
1743317|NCT00418522|3206372|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.0516||95.0|-0.38|0.0|||ANCOVA||The superiority test used a one-sided 2.5% level of significance.|With an established non-inferiority claim, an additional test for superiority was conducted (ie, the margin was 0.0%).|
1743318|NCT00418522|3206372|Non-Inferiority or Equivalence|The non-inferiority test utilized a one-sided 2.5% level of significance.|Mean Difference (Final Values)|-0.19|||<|0.0001||95.0|-0.38|0.0|||ANCOVA||A confidence interval (CI) approach was presented with a two-sided 95% CI of the difference between treatment and control.|The null hypothesis was that the inhaled human insulin group was inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, while the alternate hypothesis is that the inhaled human insulin group was not inferior to the insulin glargine group with respect to 26-week change from baseline in HbA1c, given the predetermined non-inferiority margin of 0.4%.|
1743319|NCT00418379|3206373|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1743320|NCT00418379|3206373|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1743321|NCT00418262|3206377|Superiority||Mean Difference (Net)|0.39|||||2-Sided|95.0|-0.69|1.38|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743322|NCT00418262|3206377|Superiority||Mean Difference (Net)|0.39|||||2-Sided|95.0|-0.69|1.38|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743323|NCT00418262|3206378|Superiority||Mean Difference (Net)|-2.44|||||2-Sided|95.0|-3.03|-1.9|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743324|NCT00418262|3206378|Superiority||Mean Difference (Net)|-7.4|||||2-Sided|95.0|-7.76|-7.04|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743325|NCT00418262|3206379|Superiority||Mean Difference (Net)|0.08|||||2-Sided|95.0|-0.19|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743326|NCT00418262|3206379|Superiority||Mean Difference (Net)|0.08|||||2-Sided|95.0|-0.19|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743327|NCT00418262|3206380|Superiority||Mean Difference (Net)|-0.22|||||2-Sided|95.0|-0.72|0.27|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743451|NCT00414973|3206624|Superiority or Other||Mean Difference (Net)|-0.96|Standard Error of the Mean|1.9||0.6156||95.0|-4.85|2.92|||ANCOVA||Difference = Teriparatide minus Calcitonin||
1743328|NCT00418262|3206380|Superiority||Mean Difference (Net)|-0.11|||||2-Sided|95.0|-0.36|0.13|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743329|NCT00418262|3206381|Superiority||Mean Difference (Net)|0.07|||||2-Sided|95.0|-0.21|0.32|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743330|NCT00418262|3206381|Superiority||Mean Difference (Net)|0.07|||||2-Sided|95.0|-0.21|0.32|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743331|NCT00418262|3206382|Superiority||Mean Difference (Net)|-0.09|||||2-Sided|95.0|-0.57|0.47|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743332|NCT00418262|3206382|Superiority||Mean Difference (Net)|-0.05|||||2-Sided|95.0|-0.28|0.24|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743333|NCT00418262|3206383|Superiority||Median Difference (Net)|-0.12|||||2-Sided|95.0|-0.64|0.39|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743334|NCT00418262|3206383|Superiority||Mean Difference (Net)|-0.06|||||2-Sided|95.0|-0.32|0.2|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743335|NCT00418262|3206384|Superiority||Mean Difference (Net)|-0.01|||||2-Sided|95.0|-0.56|0.52|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743336|NCT00418262|3206384|Superiority||Mean Difference (Net)|0.0|||||2-Sided|95.0|-0.28|0.26|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743337|NCT00418262|3206385|Superiority||Mean Difference (Net)|-0.06|||||2-Sided|95.0|-0.49|0.49|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743376|NCT00417482|3206465|Superiority or Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.43||0.149|2-Sided|95.0|-1.47|0.23|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in PSMS, between randomization and week 16, is zero.|
1743509|NCT00413400|3206856|Superiority or Other|||||||0.2|||||||ANCOVA|||treatment effect (etanercept vs. placebo) using ANCOVA including baseline CRP, age, and race|
1743338|NCT00418262|3206385|Superiority||Mean Difference (Net)|-0.03|||||2-Sided|95.0|-0.24|0.24|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743339|NCT00418262|3206386|Superiority||Mean Difference (Net)|0.04|||||2-Sided|95.0|-0.2|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743340|NCT00418262|3206386|Superiority||Mean Difference (Net)|0.04|||||2-Sided|95.0|-0.2|0.35|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743341|NCT00418262|3206387|Superiority||Mean Difference (Net)|-0.07|||||2-Sided|95.0|-0.36|0.18|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743342|NCT00418262|3206387|Superiority||Mean Difference (Net)|-0.07|||||2-Sided|95.0|-0.36|0.18|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743343|NCT00418262|3206388|Superiority||Mean Difference (Net)|0.13|||||2-Sided|95.0|-0.16|0.4|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743344|NCT00418262|3206388|Superiority||Mean Difference (Net)|0.13|||||2-Sided|95.0|-0.16|0.4|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743345|NCT00418262|3206389|Superiority||Mean Difference (Net)|0.1|||||2-Sided|95.0|-0.17|0.36|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743346|NCT00418262|3206389|Superiority||Mean Difference (Net)|0.1|||||2-Sided|95.0|-0.17|0.36|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743347|NCT00418262|3206390|Superiority||Mean Difference (Net)|0.24|||||2-Sided|95.0|-0.23|0.77|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743377|NCT00417482|3206466|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.14||0.13|2-Sided|95.0|-0.5|0.07|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in AIMS, between randomization and week 16, is zero.|
1743510|NCT00413283|3206865|Superiority or Other|||||||0.662|||||||Fisher Exact||||
1743511|NCT00413283|3206865|Superiority or Other|||||||1|||||||Fisher Exact||||
1743348|NCT00418262|3206390|Superiority||Mean Difference (Net)|0.12|||||2-Sided|95.0|-0.11|0.39|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743349|NCT00418262|3206391|Superiority||Mean Difference (Net)|0.11|||||2-Sided|95.0|-0.42|0.6|||||This is the (growth) model-estimated mean difference between visit 1 and visit 10. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743350|NCT00418262|3206391|Superiority||Mean Difference (Net)|0.05|||||2-Sided|95.0|-0.21|0.3|||||This is the (growth) model-estimated mean difference between visit 1 and visit 8. This estimate utilizes imputed values for missing observations.|"Tested single-group change over time from baseline (visit 1) to the study endpoint (visit 10). The null hypothesis stated that there was no change in PSE ratings over time. Bayesian growth curve models were estimated using Markov Chain Monte Carlo techniques. Several linear and nonlinear trajectory models were compared on fit to data. Mean differences and confidence intervals were generated from the posterior-predictive distribution of the best fitting growth model."|
1743351|NCT00418093|3206414|Superiority or Other||Single Proportion|0.684|||||2-Sided|95.0|0.434|0.874|||||Estimation of a single proportion (partial response rate) with exact 95% Binomial confidence interval||
1743352|NCT00418093|3206414|Superiority or Other||Proportion|0.684|||||2-Sided|95.0|0.43|0.87|||||Point estimate of PR and its exact 95% CI based on Binomial Model||
1743353|NCT00418028|3206415|Superiority||Hazard Ratio (HR)|1.2||||0.2556|2-Sided|95.0|0.88|1.63|||Log Rank||||
1743354|NCT00418028|3206416|Superiority|||||||0.4984|||||||Chi-squared||||
1743355|NCT00418028|3206417|Superiority||Hazard Ratio (HR)|0.91||||0.5688|2-Sided|95.0|0.66|1.25|||Log Rank||||
1743356|NCT00418028|3206418|Superiority||Hazard Ratio (HR)|1.12||||0.4676|2-Sided|95.0|0.83|1.5|||Log Rank||||
1743357|NCT00418028|3206419|Superiority||Hazard Ratio (HR)|1.18||||0.5703|2-Sided|95.0|0.67|2.07|||Log Rank||||
1743358|NCT00418028|3206420|Superiority|||||||0.8269|||||||Chi-squared||||
1743359|NCT00418028|3206421|Non-Inferiority or Equivalence|"If we assume that the non-inferiority level is up to 15% lower (equivalent to a median progression-free time of 3 months), for a one-sided error α=0.05, and 80% power, are necessary 88 patients per group.~Considering an dropout rate of around 10%, the number of patients would be 98 per group."|Hazard Ratio (HR)|1.3||||0.1224|2-Sided|95.0|0.9|1.7|||Log Rank||||
1743360|NCT00418015|3206422|Superiority or Other|||||||0.84|||||||Wilcoxon (Mann-Whitney)||||
1743361|NCT00418015|3206422|Superiority or Other|||||||0.23|||||||Wilcoxon (Mann-Whitney)||||
1743362|NCT00418015|3206423|Superiority or Other|||||||0.02|||||||Chi-squared, Corrected||||
1743363|NCT00418015|3206424|Superiority or Other|||||||0.06|||||||Chi-squared, Corrected||||
1743364|NCT00418015|3206425|Superiority or Other|||||||0.15|||||||Log Rank||||
1743365|NCT00418015|3206426|Superiority or Other|||||||0.54|||||||Log Rank|||Log rank test|
1743366|NCT00417989|3206427|Superiority or Other||Mean Difference (Final Values)|18.6|Standard Deviation|25.53|||2-Sided||||||||||
1743367|NCT00417989|3206428|Superiority or Other||Mean Difference (Final Values)|3.0|Standard Deviation|7.75|||||||||||||
1743368|NCT00417989|3206430|Superiority or Other||Mean Difference (Final Values)|-6.5|Standard Deviation|16.0|<|0.001||95.0|-9.76|-3.273|||ANCOVA||||
1743369|NCT00417989|3206431|Non-Inferiority or Equivalence|No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.||||||0.05|||||||ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC|||
1743370|NCT00417989|3206432|Non-Inferiority or Equivalence|No power calculation based on this endpoint. Results will be calculated on testing for statistical difference between arms.||||||0.05|||||||ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline AUC|||
1743371|NCT00417989|3206433|Superiority or Other||Odds Ratio (OR)|1.2|Standard Deviation|2.0||0.84|2-Sided|95.0|0.64|2.41|||Mantel Haenszel||||
1743372|NCT00417989|3206435|Non-Inferiority or Equivalence|Superiority test with margin of 0.35|Mean Difference (Final Values)|0.35|Standard Deviation|1.2||0.05|2-Sided|95.0|0.24|0.46||Confidence Interval 95%|ANCOVA|ANVOCA is adjusted by study group, gender, pooled site, continuous age, duration of diabetes, BMI, and Baseline glycated hemoglobin level (A1C)||Null - There is no treatment group difference in A1c change from baseline to Week 52. Calculated that the enrollment of 495 patients would provide a power of 90% to detect an absolute difference of 0.35 percentage points in the primary outcome, assuming a SD of 1.2%.|
1743373|NCT00417859|3206454|Superiority|||||||0.05|||||||Wilcoxon (Mann-Whitney)|||FB group was designated the control group. We determined a sample size based in clinical criteria. Using an α of 0.05 and β of 0.8, the required sample size was calculated to be 24 patients in each group to achieve a power of 80%. Descriptive analysis was completed on demographic information and clinical and radiological outcomes. Nonparametric tests (Wilcoxon’s signed ranks or rank sum tests) were used for comparison of scores. The chi-squared test was used for dichotomous variables.|
1743374|NCT00417612|3206463|Superiority or Other (legacy)|||||||0.007|||||||ANOVA||||
1743375|NCT00417482|3206464|Superiority or Other||Mean Difference (Final Values)|-0.41|Standard Error of the Mean|1.69||0.81|2-Sided|95.0|-3.77|2.95|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in weight, between randomization and week 16, is zero.|
1743447|NCT00415194|3206610|Superiority or Other||Hazard Ratio (HR)|0.88||||0.166|2-Sided|95.0|0.76|1.03|||Stratified Log Rank||||
1743378|NCT00417482|3206467|Superiority or Other||Mean Difference (Final Values)|-0.54|Standard Error of the Mean|0.48||0.26|2-Sided|95.0|-1.5|0.41|||t-test, 2 sided|||The null hypothesis is that the difference between placebo and risperidone groups in terms of mean change in EPS, between randomization and week 16, is zero.|
1743379|NCT00417482|3206468|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.49||0.94||95.0|-1.01|0.93|||t-test, 2 sided|||The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in TESS.|
1743380|NCT00417482|3206469|Superiority or Other||Mean Difference (Final Values)|0.64|Standard Error of the Mean|0.36||0.08|2-Sided|95.0|-0.08|1.35|||t-test, 2 sided|||The null hypothesis is that there is no difference between the risperidone and placebo groups over the 16 week period post randomization, with respect to change in MMSE.|
1743381|NCT00417482|3206470|Superiority or Other||Hazard Ratio (HR)|4.88||||0.02|2-Sided|95.0|1.08|21.98|||stratified cox analyses|||Similar analyses were used to test the secondary hypothesis in the relapse risk in weeks 17 to 32 of Phase B between the patients who continued to receive risperidone (Arm 1) & the patients who discontinued risperidone at week 16 & were switched to placebo (Arm 2). Patients who died & those in whom a relapse was considered to be imminent before they were dropped out in Phase B were classified as having relapse.|
1743382|NCT00417482|3206471|Superiority or Other||Hazard Ratio (HR)|1.94||||0.02|2-Sided|95.0|1.09|3.45|||Stratified Cox analysis|||The primary hypothesis of a difference in survival functions between the initial Phase B placebo (Arm 3) and risperidone continuation (Arms 1+2) conditions was tested in the primary analysis using the stratified Cox analysis. For descriptive purposes, the overall rate of relapse was assessed as the number of follow-up or for secondary interpretative support, as a simple proportion of patients entering a 16-week period.|
1743383|NCT00417079|3206482|Superiority or Other|||||||0.6286|||||||Chi-squared||||
1743384|NCT00417079|3206483|Superiority or Other||Cox Proportional Hazard|0.91||||0.5192|2-Sided|95.0|0.69|1.19|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) < 1 favours the cabazitaxel group and > 1 favours the mitoxantrone group.||
1743385|NCT00417079|3206484|Superiority or Other|||||||0.0002|||||||Chi-squared||||
1743386|NCT00417079|3206485|Superiority or Other||Cox Proportional Hazard|0.75||||0.001|2-Sided|95.0|0.63|0.9|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) < 1 favours the cabazitaxel group and > 1 favours the mitoxantrone group.||
1743387|NCT00417079|3206486|Superiority or Other||Cox Proportional Hazard|0.61|||<|0.0001|2-Sided|95.0|0.49|0.76|||Log Rank|Log-rank comparisons stratified according to disease measurability and ECOG performance status.|Hazard ratio (HR) < 1 favours the cabazitaxel group and > 1 favours the mitoxantrone group.||
1743388|NCT00417079|3206487|Superiority or Other|||||||0.0005|||||||Chi-squared||||
1743389|NCT00417079|3206488|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1743390|NCT00417079|3206489|Superiority or Other||||||<|0.0001||||||A 2-sided significance level of 0.0452 was used for the final analysis based on an interim analysis performed after 307 events with an adjusted significance level of 0.016 based on the O'Brien-Fleming type 1 error spending function.|Log Rank|Analysis was performed by using a log-rank comparisons stratified according to disease measurability and ECOG performance status (0-1 versus 2)||The study required an estimated sample size of 720 patients (360 per arm) in order to detect a 25% reduction in the hazard ratio for death in the cabazitaxel group relative to the mitoxantrone group with 90% power. The final analysis was planned for when 511 deaths had occurred.|
1743391|NCT00417027|3206490|Superiority or Other|||||||0.85|||||||Kruskal-Wallis||||
1743392|NCT00417027|3206491|Superiority or Other|||||||0.41|||||||Kruskal-Wallis||||
1743393|NCT00417027|3206492|Superiority or Other|||||||0.72||||||Analysis applies to all rows.|Chi-squared, Corrected|||Analysis apply to all rows. Only 1 comparison was made between the groups in distribution of number of bolus doses.|
1743394|NCT00417027|3206493|Superiority or Other|||||||0.69|||||||Kruskal-Wallis||||
1743395|NCT00417027|3206494|Superiority or Other|||||||0.32|||||||Kruskal-Wallis||||
1743396|NCT00417027|3206495|Superiority or Other|||||||0.54|||||||Kruskal-Wallis||||
1743397|NCT00417027|3206496|Superiority or Other|||||||0.02||||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)||||
1743398|NCT00417027|3206496|Superiority or Other|||||||0.005||||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)||||
1743399|NCT00417027|3206496|Superiority or Other||||||>|0.05||||||Bonferroni corrected for 6 comparisons|Wilcoxon (Mann-Whitney)||||
1743400|NCT00416624|3206507|Non-Inferiority or Equivalence|If the hematopoietic response rate in the standard therapy group is far from 50% (<25% or >75%), the above sample size will provide an 80% power to detect a difference as small as 25%.|||||>|0.56|||||||Fisher Exact|||With 80 patients per treatment arm, there will be about 80% power to detect a difference through Fisher's exact test across two treatment arms of 25% in the true percentage of patients that experience a hematopoietic response as defined previously, if that percentage is at least 30% in the superior group, again with a 1.7% type I error rate.|
1743401|NCT00416624|3206510|Non-Inferiority or Equivalence|If the hematopoietic response rate in the standard therapy group is far from 50% (<25% or >75%), the > above sample size will provide an 80% power to detect a difference as small as > 25%.|||||>|0.49|||||||Fisher Exact|||With 80 patients per treatment arm, there will be > about 80% power to detect a difference through Fisher's exact test across two > treatment arms of 25% in the true percentage of patients that experience a > hematopoietic response as defined previously, if that percentage is at least 30% in > the superior group, again with a 1.7% type I error rate.|
1743402|NCT00416624|3206512|Non-Inferiority or Equivalence|A sample size of 80 patients per arm will provide > 80% power to detect differences between average hemoglobin levels in the > reference arm and another treatment of 50% of the standard deviation. Note that > typically one would expect the estimates for the standard deviation at a single time > point to differ from the standard deviation for the difference from baseline.|||||>|0.13|||||||Fisher Exact||||
1743448|NCT00415194|3206611|Superiority or Other||Hazard Ratio (HR)|0.87||||0.082|2-Sided|95.0|0.75|1.02|||Stratified Log Rank||||
1743449|NCT00414973|3206623|Superiority or Other|||||||0.0006||||||P-value for 24 Week Percentage Change.|Wilcoxon Rank-Sum Test||||
1743403|NCT00416624|3206514|Non-Inferiority or Equivalence|If the hematopoietic response rate in the standard therapy group is far from 50% (<25% or >75%), the > above sample size will provide an 80% power to detect a difference as small as > 25%.|||||>|0.41|||||||Fisher Exact|||With 80 patients per treatment arm, there will be > about 80% power to detect a difference through Fisher's exact test across two > treatment arms of 25% in the true percentage of patients that experience a > hematopoietic response as defined previously, if that percentage is at least 30% in > the superior group, again with a 1.7% type I error rate.|
1743404|NCT00416572|3206518|Superiority or Other||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.|
1743405|NCT00416572|3206518|Superiority or Other||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.|
1743406|NCT00416572|3206518|Superiority or Other||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.|
1743407|NCT00416572|3206518|Superiority or Other||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome|
1743408|NCT00416572|3206519|Superiority or Other||Standardized beta|0.15|||=|0|2-Sided||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.|
1743409|NCT00416572|3206519|Superiority or Other||Standardized beta|0.25|||<|0.001|2-Sided||||||Regression, Linear|||Comparison between the education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.|
1743410|NCT00416572|3206519|Superiority or Other||Standardized beta|0.14|||=|0|2-Sided||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.|
1743411|NCT00416572|3206519|Superiority or Other||||||>|0.5|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.|
1743412|NCT00416572|3206520|Superiority or Other||standardized beta|-0.23|||<|0.001|2-Sided||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.|
1743413|NCT00416572|3206520|Superiority or Other||standardized beta|-0.12|||=|0|2-Sided||||||Regression, Linear|||Comparison between education intervention and the control condition at final follow-up (13 months post-intervention). The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.|
1743414|NCT00416572|3206520|Superiority or Other||||||>|0.05|||||||Regression, Linear|||Comparison between nutrition education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.|
1743415|NCT00416572|3206520|Superiority or Other||||||>|0.05|||||||Regression, Linear|||Comparison between education intervention and the control condition at 4 months post-intervention. The full regression model contained 2 dummy-coded variables (education intervention vs. control condition and nutrition education intervention vs. control condition), and the baseline measure of the outcome.|
1743416|NCT00416182|3206550|Superiority or Other|||||||0.4||||||P <0.05 is considered significant|t-test, 2 sided||||
1743417|NCT00416182|3206551|Superiority or Other|||||||0.003||||||P-value < 0.05 is considered significant|t-test, 2 sided||||
1743418|NCT00416182|3206552|Superiority or Other|||||||0.048||||||P-value of < 0.05 is considered significant.|t-test, 2 sided||||
1743419|NCT00416182|3206553|Superiority or Other|||||||0.2||||||P-value of < 0.05 is considered significant|t-test, 2 sided||||
1743420|NCT00416078|3206554|Superiority or Other|||||||0.64|||||||Fisher Exact||||
1743421|NCT00416078|3206555|Superiority or Other|||||||0.67||||||t test for differential change over time in the two groups t(29)=.43|Mixed Models Analysis|||intent to treat analysis|
1743422|NCT00416078|3206556|Superiority or Other|||||||0.49||||||t test for differential change over time in the two groups t(29)=.70|Mixed Models Analysis|||intent to treat analysis|
1743423|NCT00416078|3206557|Superiority or Other|||||||0.79||||||t test of differential change over time in the two groups t(29)=.27|Mixed Models Analysis|||intent to treat analysis|
1743424|NCT00416078|3206558|Superiority or Other|||||||0.51||||||t test of differential change over time in the two groups t(30)=.67|Mixed Models Analysis|||intent to treat analysis|
1743425|NCT00416078|3206559|Superiority or Other|||||||0.65||||||F test of time X group effect F(1,3)=.26|Mixed Models Analysis|||intent to treat|
1743450|NCT00414973|3206623|Superiority or Other|||||||0.0026||||||P-value for Week 12 Percentage Change.|Wilcoxon Rank-Sum Test||||
1743426|NCT00415623|3206572|Superiority or Other||Odds Ratio (OR)|4.16|||<|0.001||95.0|2.12|8.19|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (<=64, >=65) as a factor. The significance level was 0.05 (two-sided).|
1743427|NCT00415623|3206573|Superiority or Other||Odds Ratio (OR)|2.55||||0.001||95.0|1.5|4.36|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (<=64, >=65) as a factor. The significance level was 0.05 (two-sided).|
1743428|NCT00415623|3206574|Superiority or Other||Odds Ratio (OR)|4.46|||<|0.001||95.0|2.28|8.74|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (<=64, >=65) as a factor. The significance level was 0.05 (two-sided).|
1743429|NCT00415623|3206575|Superiority or Other||Odds Ratio (OR)|2.33||||0.002||95.0|1.36|3.99|||Regression, Logistic|||Proportions of participants (responder rates) were used for the statistical analyses. The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). The test was conducted based on a logistic regression model with baseline SBP value and body weight as covariates, and treatment group and age (<=64, >=65) as a factor. The significance level was 0.05 (two-sided).|
1743430|NCT00415623|3206576|Superiority or Other||Mean Difference (Final Values)|-4.0|||<|0.001||95.0|-5.4|-2.6|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).|
1743431|NCT00415623|3206577|Superiority or Other||Mean Difference (Final Values)|-7.1|||<|0.001||95.0|-9.1|-5.1|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).|
1743432|NCT00415623|3206578|Superiority or Other||Mean Difference (Final Values)|-4.1|||<|0.001||95.0|-5.7|-2.5|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough DBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).|
1743433|NCT00415623|3206579|Superiority or Other||Mean Difference (Final Values)|-6.7|||<|0.001||95.0|-9.0|-4.4|||ANCOVA|||The hypothesis of no group differences (null hypothesis) was tested against that of the amlodipine 10 mg arm being superior to the amlodipine 5 mg arm (alternative hypothesis). ANCOVA models with the trough SBP at baseline, body weight, and age as covariates, and the treatment group and study site as factors was used. The test was performed with a significance level of 0.05 (two-sided).|
1743434|NCT00415610|3206583|Superiority or Other||||||<|0.5||||||Observed average SBP change at 2 hrs after treatment initiation between subjects who did or did not have neurologic deterioration within 24 hrs.|Wilcoxon rank sum test|Mean decrease measured for subjects with neurological deterioration and subjects without neurological deterioration.||Done as a surrogate to evaluate the relationship between early SBP reduction and safety events.|
1743435|NCT00415610|3206584|Superiority or Other||||||<|0.01||||||The repeated measure analysis of the hourly average SBP was calculated with and without adjusting for baseline NIHSS and age.|repeated measure|Adjusted for initial deficit severity of using baseline NIHSS instead of GCS to better discriminate among patients with GCS score > 8.||The hourly average (of maximum and minimum) SBP measurements were graphed with box-and-whiskers plot. In addition, a repeated measures analysis of the 25 average SBP (baseline and subsequent 24 hourly measures) was conducted with a mixed effects model (assuming autoregressive covariance structure in SAS version 9.1 PROC MIXED) to determine statistically the effect of treatment intensity (tier) on the average SBP over the 24 hrs with and without adjustment for baseline NIHSS score and age.|
1743436|NCT00415597|3206585|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Null hypothesis: Percent change from baseline = 0|
1743437|NCT00415597|3206586|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Null hypothesis: Percent change from baseline = 0|
1743438|NCT00415532|3206588|Superiority or Other|||||||0.0246||||||Significant level is set at 0.05|Mixed Models Analysis||||
1743439|NCT00415532|3206589|Superiority or Other|||||||0.0076||||||Significant level is set at 0.05|Mixed Models Analysis||||
1743440|NCT00415532|3206590|Superiority or Other|||||||0.3434||||||Significant level is set at 0.05|Mixed Models Analysis||||
1743441|NCT00415532|3206591|Superiority or Other|||||||0.0133||||||Significant level is set at 0.05|Mixed Models Analysis||||
1743442|NCT00415532|3206594|Superiority or Other||Odds Ratio (OR)|0.307||||0.0005||95.0|0.154|0.611||Significant level is set at 0.05|Cochran-Mantel-Haenszel||||
1743443|NCT00415532|3206595|Superiority or Other||Odds Ratio (OR)|0.172|||<|0.0001||95.0|0.084|0.352||Significant level is set at 0.05|Cochran-Mantel-Haenszel||||
1743444|NCT00415194|3206607|Superiority or Other||Hazard Ratio (HR)|0.86||||0.2|2-Sided|95.0|0.69|1.07|||Stratified Log Rank||||
1743445|NCT00415194|3206608|Superiority or Other||Hazard Ratio (HR)|0.92||||0.811|2-Sided|95.0|0.56|1.53|||Stratified Log Rank||||
1743446|NCT00415194|3206609|Superiority or Other|||||||0.061|||||||Unadjusted normal distribution|p-value is based on an unadjusted, normal distribution approximation for differences in rates.|||
1743452|NCT00414973|3206625|Superiority or Other||Mean Difference (Net)|2.63|Standard Error of the Mean|2.2||0.2409||95.0|-1.87|7.13|||ANCOVA||Difference = Teriparatide minus Calcitonin||
1743453|NCT00414973|3206626|Superiority or Other||||||<|0.0001||||||P-value for Week 24 Percentage Change.|Wilcoxon Rank-Sum Test||||
1743454|NCT00414973|3206626|Superiority or Other||||||<|0.0001||||||P-value for Week 12 Percentage Change.|Wilcoxon Rank-Sum Test||||
1743455|NCT00414973|3206627|Superiority or Other||Mean Difference (Net)|0.08|Standard Error of the Mean|0.7||0.9062||95.0|-1.3|1.46|||ANCOVA||Difference = Teriparatide minus Calcitonin||
1743456|NCT00414973|3206628|Superiority or Other||Mean Difference (Net)|4.39|Standard Error of the Mean|0.76|<|0.0001||95.0|2.89|5.89||There were no adjustments for multiple comparisons.|ANCOVA||Difference = Teriparatide minus Calcitonin|Null hypothesis=no difference between percentage changes from baseline in lumbar spine bone mineral density for female patients receiving teriparatide compared to female patients receiving calcitonin.|
1743457|NCT00414908|3206629|Superiority or Other||||||<|0.001|||||||Paired t-test|Mean difference based on all subjects combined using the paired t-test between baseline and visit 8 or early termination|||
1743458|NCT00414908|3206633|Superiority or Other||LS Means difference|-0.76||||0.005||95.0|-1.27|-0.24|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal). The hypothesis was to show superior efficacy of pancrelipase capsules over placebo.~For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool frequency at baseline as a covariate."|
1743459|NCT00414908|3206634|Superiority or Other||LS Means difference|-11.68|||<|0.0001||95.0|-17.3|-6.06|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal).~The hypothesis was to show superior efficacy of pancrelipase delayed release capsules over placebo. For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool nitrogen at baseline as a covariate."|
1743460|NCT00414908|3206635|Superiority or Other||LS Means difference|-112.45|||<|0.0001||95.0|-147.04|-77.87|||ANCOVA|||"The following null hypothesis was tested (μ0 and μ1 denote the treatment group means in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase capsules are equal).~The hypothesis was to show superior efficacy of pancrelipase delayed release capsules over placebo.~For this secondary efficacy variable, an analysis of covariance (ANCOVA) model was assumed with the treatment group as a fixed factor and the Stool fat at baseline as a covariate."|
1743461|NCT00414908|3206636|Superiority or Other|||||||0.0002|||||||Non parametric ANCOVA|||The following null hypothesis was tested (μ0 and μ1 denote the treatment group means respectively in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase delayed release capsules are equal). The hypothesis corresponded to the primary objective to show superior efficacy of pancrelipase delayed release capsules over placebo. A non-parametric ANCOVA was used because the necessary assumptions were not met for the parametric ANCOVA.|
1743462|NCT00414908|3206637|Superiority or Other||||||<|0.0001|||||||Non parametric ANCOVA|||The following null hypothesis was tested (μ0 and μ1 denote the treatment group means respectively in the placebo and pancrelipase delayed release capsules group): H0: μ0 = μ1 (i.e., placebo and pancrelipase delayed release capsules are equal). The hypothesis corresponded to the primary objective to show superior efficacy of pancrelipase delayed release capsules over placebo. A non-parametric ANCOVA was used because the necessary assumptions were not met for the parametric ANCOVA.|
1743463|NCT00414817|3206638|Superiority or Other||Risk Ratio (RR)|1.0||||0.852|2-Sided|95.0|0.96|1.06||2-tailed p-value based on overdispersed Poisson regression adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline mMPR|overdispersed Poisson regression|||In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.|
1743464|NCT00414817|3206639|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.175|2-Sided|95.0|-0.23|0.04|||Regression, Linear|2-tailed p-value adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline adherence.||In all of our analyses we used duration of follow-up as a weighting variable. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above.|
1743465|NCT00414817|3206640|Superiority or Other||Mean Difference (Final Values)|0.018||||0.002|2-Sided|95.0|0.006|0.03|||Regression, Linear|2-tailed p-value based on linear regression adjusted for site, age, sex, co-morbid COPD, baseline use of short acting beta agonists, and baseline mMPR|Estimated adherence was approximately 2 percentage points higher for intervention group than for usual care group.|In all of our analyses we used duration of follow-up as a weighting variable to reflect the fact that our adherence measure becomes more accurate and reliable with longer follow-up. This weighting is reflected both in the formal statistical analyses and in the presentation of means and standard deviations given above. Also, sensitivity analyses that included daily oral steroid users and those with fewer than 3 months of follow-up yielded similar results to those presented here.|
1743466|NCT00414726|3206641|Superiority or Other|||||||0.68|||||||Wilcoxon (Mann-Whitney)|We used the Van Elteren extension of the Wilcoxin rank sum test that adjusts for stratified randomization.|||
1743467|NCT00414726|3206642|Superiority or Other|||||||0.91|||||||Wilcoxon (Mann-Whitney)|We used the Van-Elteren extension of the Wilcoxon rank sum test; ajustments made for baseline NIHSS categories (4-11)(12-20)(>20).||Subjects were analyzed using an intention to treat approach. All subjects were analyzed at 24 hours. For four subjects missing 24-hour NIHSS scores, the change score was given the highest possible value.|
1743468|NCT00414700|3206648|Non-Inferiority or Equivalence|Non-inferiority margin = -9 % points|Mean Difference (Final Values)|1.81|Standard Error of the Mean|2.4||||95.0|-3.28|6.9|||||||
1743469|NCT00414700|3206649|Superiority or Other|||||||0.01|||||||ANCOVA|Adjusted for age, associated lesion(s) and location of lesion.||Test for superiority|
1743470|NCT00414700|3206650|Superiority or Other|||||||0.003|||||||ANCOVA|Adjusted for age, associated lesion(s) and location of lesion||Test for superiority|
1743512|NCT00413283|3206865|Superiority or Other|||||||0.662|||||||Fisher Exact||||
1743471|NCT00414596|3206679|Superiority or Other|||||||0.0001|||||||Mixed Models Analysis|The primary pain end-point was assessed by a mixed effect model with time (visit) and as fixed effects and subject as random effect.||"Hypothesis: Patients with chronic low back pain who undergo spinal decompression with a standardized 6-week regimen consisting of 20 treatments with the spinal decompression system would experience >50% reduction in their verbal score of pain intensity.~Power Analysis: Mean pain scores at time of enrollment were assumed to equal 6 with potential reduction in pain of 50%. To obtain 80% power at an alpha level of 0.05, sample size was estimated as 20 patients."|
1743472|NCT00414544|3206682|Non-Inferiority or Equivalence|The non-inferiority was tested.|Mean Difference (Final Values)|-0.13|Standard Deviation|0.6|||2-Sided|90.0|-2.0|1.0|||||The confidence interval is built around the mean difference of the two reporting groups.|The a priori hypothesis for statistical analysis was based on predetermined clinical relevance being set to a difference score between CosmetaLife and Control (Restylane) of -0.5. This clinical relevance was set to -0.5 because the observation scale used is not accurate below 0.5 differences. That is CosmetaLife needed to be greater than 0.5 less than Control (Restylane) in the treatment difference scores to be considered inferior.|
1743473|NCT00414466|3206686|Superiority or Other|||||||0.352||||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact||||
1743474|NCT00414466|3206686|Superiority or Other|||||||1||||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact||||
1743475|NCT00414466|3206686|Superiority or Other|||||||0.083||||||The a priori threshold for statistical significance was 0.05, two-sided. No adjustments for multiple comparisons were used.|Fisher Exact||||
1743476|NCT00414466|3206687|Superiority or Other|||||||1||||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact||||
1743477|NCT00414466|3206687|Superiority or Other|||||||1||||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact||||
1743478|NCT00414466|3206687|Superiority or Other|||||||1||||||The a priori threshold for statistical significance was 0.05, two-sided. Hochberg's adjustment for multiple comparisons was used.|Fisher Exact||||
1743479|NCT00414466|3206688|Superiority or Other|||||||0.899||||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.|
1743480|NCT00414466|3206688|Superiority or Other|||||||0.874||||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.|
1743481|NCT00414466|3206688|Superiority or Other|||||||0.802||||||The a priori threshold for statistical significance was 0.05, two-sided.|Williams test for minimum effective dose|||Williams' test for Minimum Effective Dose was used to compare each active group to the placebo.|
1743482|NCT00414206|3206715|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1743483|NCT00414050|3206719|Non-Inferiority or Equivalence|Modified Process Hepatitis B vaccine-5µg (micrograms) declared non-inferior to RECOMBIVAX HB™ if the lower bound of the 95% Confidence Interval for the ratio of Geometric Mean Titers (Modified Process Vaccine 5 micrograms/RECOMBIVAX HB™) was >= 0.67. The study had 98 percent power for this test, based on an assumption of true equality.|Ratio of geometric means|1.99|||||2-Sided|95.0|1.69|2.35||||||Comparison of Induced (effected) Geometric Mean Titer for the Modified Hepatitis B Process Vaccine and RECOMBIVAX Hepatitis B vaccine.|
1743484|NCT00413972|3206722|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1743485|NCT00413972|3206722|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1743486|NCT00413972|3206722|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1743487|NCT00413634|3206823|Superiority or Other|||||||0.011|||||||ANOVA||||
1743488|NCT00413634|3206824|Superiority or Other|||||||0.027|||||||ANOVA||||
1743489|NCT00413634|3206825|Superiority or Other|||||||0.007|||||||ANOVA||||
1743490|NCT00413634|3206826|Superiority or Other|||||||0.027|||||||ANOVA||||
1743491|NCT00413634|3206827|Superiority or Other|||||||0.557|||||||ANOVA||||
1743492|NCT00413634|3206828|Superiority or Other|||||||0.023|||||||ANOVA||||
1743493|NCT00413634|3206829|Superiority or Other|||||||0.035|||||||ANOVA||||
1743494|NCT00413634|3206830|Superiority or Other|||||||0.013|||||||ANOVA||||
1743495|NCT00413634|3206831|Superiority or Other|||||||0.378|||||||ANOVA||||
1743496|NCT00413634|3206832|Superiority or Other|||||||0.013|||||||ANOVA||||
1743497|NCT00413634|3206833|Superiority or Other|||||||0.857|||||||ANOVA||||
1743498|NCT00413634|3206836|Superiority or Other|||||||0.092|||||||ANOVA||||
1743499|NCT00413400|3206846|Superiority or Other|||||||0.55|||||||ANCOVA|||ANCOVA controlling for baseline value, age, and race|
1743500|NCT00413400|3206847|Superiority or Other|||||||0.08|||||||Repeated Measures ANCOVA|||within subject percent changes calculated then repeated measures ANCOVA performed controlling for age and race|
1743501|NCT00413400|3206848|Superiority or Other||||||<|0.0001|||||||Repeated measures ANCOVA|||within subject percent changes calculated then repeated measures ANCOVA controlling for age and race performed|
1743502|NCT00413400|3206849|Superiority or Other|||||||0.59|||||||ANCOVA|||ANCOVA controlling for baseline value, age, race|
1743503|NCT00413400|3206850|Superiority or Other|||||||0.11|||||||t-test, 2 sided||||
1743504|NCT00413400|3206851|Superiority or Other|||||||0.78|||||||t-test, 2 sided||||
1743505|NCT00413400|3206852|Superiority or Other|||||||0.46|||||||ANCOVA|||ANCOVA controlling for baseline value, age, race|
1743506|NCT00413400|3206853|Superiority or Other|||||||0.02|||||||repeated measures ANCOVA|||percent change calculated then repeated measures ANCOVA performed controlling for age and race|
1743507|NCT00413400|3206854|Superiority or Other|||||||0.02|||||||Repeated Measures ANCOVA|||within subject percent changes were calculated for each time point, then repeated measures ANCOVA controlling for age and race performed|
1743508|NCT00413400|3206855|Superiority or Other|||||||0.92|||||||Repeated Measures ANCOVA|||within subject percent changes calculated for each timepoint and repeated measures ANCOVA controlling for age and race performed|
1743525|NCT00413244|3206882|Superiority or Other|||||||0.03|||||||log mean|||Statistician used all the time points post-baseline together (“Overall”). The result gives the estimates and 95% CI of the treatment effect from longitudinal analyses (generalized estimating equation method) which basically pools data from all visits post-baseline.|
1743526|NCT00413218|3206911|Other||Adjusted Treatment Difference (%)|1.4|||||2-Sided|95.0|-7.1|10.0||||||Statistical analysis of all-cause mortality on Day 56. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.|
1743527|NCT00413218|3206911|Other||Adjusted Treatment Difference (%)|2.5|||||2-Sided|95.0|-3.8|8.9||||||Statistical analysis of all-cause mortality on Day 14. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.|
1743528|NCT00413218|3206912|Other||Adjusted Treatment Difference (%)|-8.1|||||2-Sided|95.0|-16.3|0.1|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743529|NCT00413218|3206912|Other||Adjusted Treatment Difference (%)|-11.1|||||2-Sided|95.0|-20.3|-1.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743530|NCT00413218|3206913|Other||Adjusted Treatment Difference (%)|-8.5|||||2-Sided|95.0|-16.5|-0.4|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743531|NCT00413218|3206913|Other||Adjusted Treatment Difference (%)|-11.4|||||2-Sided|95.0|-20.4|-2.5|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743532|NCT00413218|3206914|Other||Adjusted Treatment Difference (%)|-5.2|||||2-Sided|95.0|-14.7|4.3|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743533|NCT00413218|3206914|Other||Adjusted Treatment Difference (%)|-0.7|||||2-Sided|95.0|-8.1|9.6|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743534|NCT00413218|3206914|Other||Adjusted Treatment Difference (%)|-15.9|||||2-Sided|95.0|-23.5|-8.4|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743535|NCT00413218|3206914|Other||Adjusted Treatment Difference (%)|-14.9|||||2-Sided|95.0|-22.7|-7.0|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743536|NCT00413218|3206915|Other||Adjusted Treatment Difference (%)|-5.8|||||2-Sided|95.0|-15.3|3.6|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743537|NCT00413218|3206915|Other||Adjusted Treatment Difference (%)|-0.4|||||2-Sided|95.0|-9.1|8.3|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743538|NCT00413218|3206915|Other||Adjusted Treatment Difference (%)|-8.6|||||2-Sided|95.0|-15.8|-1.5|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743539|NCT00413218|3206915|Other||Adjusted Treatment Difference (%)|-8.2|||||2-Sided|95.0|-15.4|-0.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743540|NCT00413218|3206916|Other||Adjusted Treatment Difference %|-5.4|||||2-Sided|95.0|-15.0|4.2|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743541|NCT00413218|3206916|Other||Adjusted Treatment Difference %|-10.9|||||2-Sided|95.0|-19.9|-1.9|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743815|NCT00410072|3207412|Superiority or Other||Mean Difference (Final Values)|1.1|||||2-Sided|95.0|-3.9|6.1||||||Analysis at Week 96|
1743542|NCT00413218|3206917|Other||Adjusted Treatment Difference (%)|-2.7|||||2-Sided|95.0|-12.2|6.8|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.|
1743543|NCT00413218|3206918|Non-Inferiority|The lower bound of the 95% CI for the adjusted treatment difference was compared to the protocol prespecified noninferiority margin (NIM) value of -15%. If the lower bound were greater than -15%, isavuconazole would be declared as noninferior to caspofungin.|Adjusted Treatment Difference (%)|-10.8|||||2-Sided|95.0|-19.9|-1.8|||||The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.|The adjusted treatment difference (ISA-CAS) was calculated by a stratified Cochran-Mantel-Haenszel (CMH) method with the strata of geographical region and baseline neutropenic status.|
1743544|NCT00413153|3206928|Superiority or Other|||||||0.0002|||||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).|
1743545|NCT00413153|3206929|Superiority or Other|||||||0.004|||||||Repeated Measures Ancova|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).|
1743546|NCT00413153|3206930|Superiority or Other|||||||0.22|||||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).|
1743547|NCT00413153|3206931|Superiority or Other|||||||0.72|||||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).|
1743548|NCT00413153|3206932|Superiority or Other|||||||0.047|||||||t-test, 2 sided||||
1743549|NCT00413153|3206933|Superiority or Other|||||||0.02|||||||Repeated measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).|
1743550|NCT00413153|3206934|Superiority or Other|||||||0.002|||||||Repeated Measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs.LPV/r).|
1743551|NCT00413153|3206935|Superiority or Other|||||||0.12|||||||Repeated measures ANCOVA|||Repeated measures ANCOVA, controlling for baseline values, used to assess treatment effect of the randomization over 6 months (net difference over time between ATV/r vs. LPV/r)|
1743552|NCT00413153|3206936|Superiority or Other|||||||0.035|||||||t-test, 2 sided|||Initial samples size of N=16 calculated to provide 80% power to detect a 30% change in muscle glucose uptake between groups. Student's t-test used to compare change from baseline and determine treatment effect (net difference over time between the ATV/r vs. LPV/r groups).|
1743553|NCT00413010|3206958|Superiority or Other||Mean Difference (Final Values)|-1.0||||||95.0|-2.1|0.1|||||Difference is pregabalin minus placebo.|Week 8|
1743554|NCT00413010|3206958|Superiority or Other||Mean Difference (Final Values)|-0.9||||||95.0|-1.8|0.0|||||Difference is pregabalin minus placebo.|Week 6|
1743555|NCT00413010|3206958|Superiority or Other||Mean Difference (Final Values)|-0.4||||||95.0|-1.3|0.5|||||Difference is pregabalin minus placebo.|Week 5|
1743556|NCT00413010|3206958|Superiority or Other||Mean Difference (Final Values)|-1.3||||||95.0|-2.1|-0.6|||||Difference is pregabalin minus placebo.|Week 4|
1743557|NCT00413010|3206958|Superiority or Other||Mean Difference (Final Values)|-0.7||||||95.0|-1.6|0.1|||||Difference is pregabalin minus placebo.|Week 3|
1743558|NCT00413010|3206958|Superiority or Other||Mean Difference (Final Values)|-0.6||||||95.0|-1.5|0.2|||||Difference is pregabalin minus placebo.|Week 2|
1743559|NCT00413010|3206958|Superiority or Other||Mean Difference (Final Values)|-0.8||||||95.0|-1.5|0.0|||||Difference is pregabalin minus placebo.|Week 1|
1743560|NCT00413010|3206959|Superiority or Other||Odds Ratio (OR)|1.56||||||95.0|1.07|2.3|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. The odds of having an increasingly better response for pregabalin relative to the odds of having an increasingly better response for placebo.|Week 8 Last Observation Carried Forward (LOCF)|
1743561|NCT00413010|3206960|Superiority or Other||Odds Ratio (OR)|1.12||||||95.0|0.71|1.76|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8 (LOCF) Last Observation Carried Forward|
1743562|NCT00413010|3206960|Superiority or Other||Odds Ratio (OR)|1.06||||||95.0|0.61|1.84|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8|
1743563|NCT00413010|3206960|Superiority or Other||Odds Ratio (OR)|1.45||||||95.0|0.84|2.5|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 6|
1743564|NCT00413010|3206960|Superiority or Other||Odds Ratio (OR)|1.24||||||95.0|0.72|2.11|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 5|
1743565|NCT00413010|3206960|Superiority or Other||Odds Ratio (OR)|1.26||||||95.0|0.77|2.05|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 4|
1743566|NCT00413010|3206960|Superiority or Other||Odds Ratio (OR)|1.75||||||95.0|1.09|2.82|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 3|
1743567|NCT00413010|3206960|Superiority or Other||Odds Ratio (OR)|1.58||||||95.0|1.01|2.47|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 2|
1743962|NCT00408876|3207588|Superiority or Other||Mean Difference (Net)|-0.1||||0.796||95.0|-0.82|0.63|||t-test, 2 sided||||
1743568|NCT00413010|3206960|Superiority or Other||Odds Ratio (OR)|1.54||||||95.0|0.96|2.47|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 1|
1743569|NCT00413010|3206961|Superiority or Other|||||||0.0137||||||P-value corresponds to the 2-sided log-rank test.|Log Rank|2-sided log-rank test||Kaplan Meier product limit estimate for calculating median time in days to onset sustained HAM-A Improvement.|
1743570|NCT00413010|3206962|Superiority or Other||Odds Ratio (OR)|1.53||||||95.0|0.92|2.53|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 8 Last Observation Carried Foward (LOCF)|
1743571|NCT00413010|3206962|Superiority or Other||Odds Ratio (OR)|1.55||||||95.0|0.85|2.83|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 8|
1743572|NCT00413010|3206962|Superiority or Other||Odds Ratio (OR)|1.33||||||95.0|0.71|2.48|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 6|
1743573|NCT00413010|3206962|Superiority or Other||Odds Ratio (OR)|1.53||||||95.0|0.82|2.85|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 5|
1743574|NCT00413010|3206962|Superiority or Other||Odds Ratio (OR)|1.8||||||95.0|0.99|3.28|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 4|
1743575|NCT00413010|3206962|Superiority or Other||Odds Ratio (OR)|2.08||||||95.0|1.09|3.97|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 3|
1743576|NCT00413010|3206962|Superiority or Other||Odds Ratio (OR)|1.49||||||95.0|0.72|3.06|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 2|
1743577|NCT00413010|3206962|Superiority or Other||Odds Ratio (OR)|2.88||||||95.0|0.94|8.8|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a remitter (yes) for pregabalin relative to the odds of being a remitter for placebo.|Week 1|
1743578|NCT00413010|3206963|Superiority or Other||Odds Ratio (OR)|1.77||||||95.0|1.12|2.79|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8 (last observation carried forward, LOCF)|
1743579|NCT00413010|3206963|Superiority or Other||Odds Ratio (OR)|1.86||||||95.0|1.08|3.22|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 8|
1743580|NCT00413010|3206963|Superiority or Other||Odds Ratio (OR)|1.52||||||95.0|0.86|2.66|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 6|
1743581|NCT00413010|3206963|Superiority or Other||Odds Ratio (OR)|1.57||||||95.0|0.9|2.73|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 5|
1743582|NCT00413010|3206963|Superiority or Other||Odds Ratio (OR)|1.8||||||95.0|1.06|3.05|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 4|
1743583|NCT00413010|3206963|Superiority or Other||Odds Ratio (OR)|3.15||||||95.0|1.76|5.66|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 3|
1743584|NCT00413010|3206963|Superiority or Other||Odds Ratio (OR)|1.61||||||95.0|0.9|2.87|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 2|
1743585|NCT00413010|3206963|Superiority or Other||Odds Ratio (OR)|3.35||||||95.0|1.37|8.24|||||The odds ratio represented the odds of demonstrating an improvement comparing pregabalin versus placebo. Odds of being a responder (yes) for pregabalin relative to the odds of being a responder for placebo.|Week 1|
1743586|NCT00413010|3206964|Superiority or Other||Mean Difference (Final Values)|-1.35|Standard Error of the Mean|0.77||||95.0|-2.9|0.2|||||Difference reflects pregabalin minus placebo.|Week 8|
1743587|NCT00413010|3206964|Superiority or Other||Mean Difference (Final Values)|-1.22|Standard Error of the Mean|0.67||||95.0|-2.5|0.1|||||Difference reflects pregabalin minus placebo.|Week 6|
1743588|NCT00413010|3206964|Superiority or Other||Mean Difference (Final Values)|-0.78|Standard Error of the Mean|0.68||||95.0|-2.1|0.5|||||Difference reflects pregabalin minus placebo.|Week 5|
1743589|NCT00413010|3206964|Superiority or Other||Mean Difference (Final Values)|-1.33|Standard Error of the Mean|0.64||||95.0|-2.6|-0.1|||||Difference reflects pregabalin minus placebo.|Week 4|
1743590|NCT00413010|3206964|Superiority or Other||Mean Difference (Final Values)|-1.45|Standard Error of the Mean|0.62||||95.0|-2.7|-0.2|||||Difference reflects pregabalin minus placebo.|Week 3|
1743591|NCT00413010|3206964|Superiority or Other||Median Difference (Final Values)|-1.04|Standard Error of the Mean|0.59||||95.0|-2.2|0.1|||||Difference reflects pregabalin minus placebo.|Week 2|
1743592|NCT00413010|3206964|Superiority or Other||Mean Difference (Final Values)|-1.33|Standard Error of the Mean|0.49||||95.0|-2.3|-0.4|||||Difference reflects pregabalin minus placebo.|Week 1|
1743816|NCT00410072|3207412|Superiority or Other||Mean Difference (Final Values)|-1.7|||||2-Sided|95.0|-5.3|1.9||||||Analysis at Week 48|
1743963|NCT00408876|3207588|Superiority or Other||Mean Difference (Net)|-0.61||||0.169||95.0|-1.48|0.26|||t-test, 2 sided||||
1743593|NCT00413010|3206965|Superiority or Other||Mean Difference (Final Values)|-1.2|Standard Error of the Mean|0.48||||95.0|-2.16|-0.26|||||Since an interim analysis was conducted and the sample size was larger than the targeted 173 subjects per group, a critical t-value adjustment was 1.977, yielding an adjusted 95% CI shown above.|Null hypothesis: no difference between Pregabalin (150-600 mg/day) BID and Placebo BID treatment groups. An initial sample size of 173 subjects per double-blind treatment group was calculated to provide at least 90% power to detect an effect size (ie, difference in the true means between 2 treatment groups/standard deviation) of 0.36 for the HAM-A total score change from Baseline using a 2-sided nominal significance level of 4.9%.|
1743594|NCT00412984|3206966|Other||Hazard Ratio (HR)|0.74|||<|0.0001|2-Sided|95.0|0.65|0.83||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin||
1743595|NCT00412984|3206968|Other||Hazard Ratio (HR)|0.63|||<|0.0001|2-Sided|95.0|0.54|0.75|||Cox Proportional Hazard Model||apixaban / warfarin|Major or Minor TIMI bleeding criteria|
1743596|NCT00412984|3206968|Other||Hazard Ratio (HR)|0.57|||<|0.0001|2-Sided|95.0|0.46|0.7||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Major TIMI bleeding event|
1743597|NCT00412984|3206969|Other||Hazard Ratio (HR)|0.6|||<|0.0001|2-Sided|95.0|0.5|0.71||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Severe or Moderate GUSTO bleeding events|
1743598|NCT00412984|3206969|Other||Hazard Ratio (HR)|0.46|||<|0.0001|2-Sided|95.0|0.35|0.6||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin|Severe GUSTO bleeding events|
1743599|NCT00412984|3206970|Other||Hazard Ratio (HR)|0.71|||<|0.0001|2-Sided|95.0|0.68|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin||
1743600|NCT00412984|3206972|Other||Hazard Ratio (HR)|0.68|||<|0.0001|2-Sided|95.0|0.61|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazard Model||apixaban / warfarin||
1743601|NCT00412984|3206975|Other||Hazard Ratio (HR)|0.8||||0.0098|2-Sided|95.0|0.67|0.95||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite Stroke/Systemic Embolism/Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants|
1743602|NCT00412984|3206977|Other||Hazard Ratio (HR)|0.89||||0.0253|2-Sided|95.0|0.8|0.99||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Myocardial Infarction / All-Cause Death|
1743603|NCT00412984|3206977|Other||Hazard Ratio (HR)|0.89||||0.0464|2-Sided|95.0|0.8|1.0||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Systemic Embolism / All-Cause Death|
1743604|NCT00412984|3206977|Other||Hazard Ratio (HR)|0.88||||0.0167|2-Sided|95.0|0.79|0.98||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Hemorrhagic Stroke / All-Cause Death|
1743605|NCT00412984|3206977|Other||Hazard Ratio (HR)|0.9||||0.0432|2-Sided|95.0|0.82|1.0||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Ischemic or Unspecified Stroke / All-Cause Death|
1743606|NCT00412984|3206977|Other||Hazard Ratio (HR)|0.88||||0.0107|2-Sided|95.0|0.8|0.97||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / MI / All-Cause Death|
1743607|NCT00412984|3206977|Other||Hazard Ratio (HR)|0.85||||0.0002|2-Sided|95.0|0.78|0.92||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / Major Bleeding / All-Cause Death|
1743608|NCT00412984|3206977|Other||Hazard Ratio (HR)|0.89||||0.0192|2-Sided|95.0|0.81|0.98||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / All-Cause Death|
1743609|NCT00412984|3206977|Other||Hazard Ratio (HR)|0.77|||<|0.0001|2-Sided|95.0|0.69|0.86||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Composite of Stroke / Systemic Embolism / Major Bleeding|
1743610|NCT00412984|3206978|Other||Hazard Ratio (HR)|0.88||||0.372|2-Sided|95.0|0.66|1.17||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Myocardial Infarction|
1743611|NCT00412984|3206978|Other||Hazard Ratio (HR)|0.87||||0.702|2-Sided|95.0|0.44|1.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Systemic Embolism|
1743612|NCT00412984|3206978|Other||Hazard Ratio (HR)|0.51||||0.0006|2-Sided|95.0|0.35|0.75||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Hemorrhagic Stroke|
1743613|NCT00412984|3206978|Other||Hazard Ratio (HR)|0.92||||0.422|2-Sided|95.0|0.74|1.13||nominal two-sided p-value was associated with a test of H0: RR=1 vs H1: RR ≠ 1|Cox Proportional Hazards Model||apixaban / warfarin|Ischemic or Unspecified Stroke|
1743614|NCT00412984|3206979|Superiority||Hazard Ratio (HR)|0.89||||0.0465|2-Sided|95.0|0.8|1.0|||Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status.|apixaban / warfarin|"4 key objectives were tested using a closed testing procedure. NI for the primary efficacy will be tested 1st. If NI is demonstrated then~superiority for the primary efficacy will be tested~if superiority for the primary efficacy is~not demonstrated, stop~demonstrated, then superiority for MB will be tested~if superiority for MB is~not demonstrated, stop~demonstrated, then superiority for all cause death will be tested All tests will be done at 1-sided α = 0.025"|
1743634|NCT00412893|3207000|Superiority or Other||Adjusted Treatment Difference|9.0|||||2-Sided|95.0|-1.231|19.186|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison|
1743817|NCT00410072|3207413|Superiority or Other||Mean Difference (Final Values)|-10.8|||||2-Sided|95.0|-21.5|-0.1||||||Analysis at Week 96|
1743615|NCT00412984|3206981|Superiority|"4 key objectives were tested using a closed testing procedure. NI for the primary efficacy will be tested 1st. If NI is demonstrated then~superiority for the primary efficacy will be tested~if superiority for the primary efficacy is~not demonstrated, stop~demonstrated, then superiority for MB will be tested~if superiority for MB is~not demonstrated, stop~demonstrated, then superiority for all cause death will be tested All tests will be done at 1-sided α = 0.025"|Hazard Ratio (HR)|0.69|||<|0.0001|2-Sided|95.0|0.6|0.8|||Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status.|apixaban / warfarin||
1743616|NCT00412984|3206983|Superiority|With an average 2.1 years follow-up and assuming a stroke rate of 1.20 per hundred patient-years, ~18,000 randomized subjects allocated in a 1:1 ratio to apixaban or warfarin group would be needed to achieve the desired power. These calculations assumed an incidence of 1% loss to follow-up. Non-inferiority for the primary efficacy endpoint will be assessed first. If non-inferiority (using a NI margin of 1.38) is demonstrated then, superiority for the primary efficacy endpoint will be tested|Hazard Ratio (HR)|0.79||||0.0114|2-Sided|95.0|0.66|0.95||2-sided P-value for superiority test|Cox Proportional Hazards Model|Model included treatment group as a covariate; stratified by investigative site and prior warfarin/vitamin K antagonist status. (experienced, naïve).|apixaban / warfarin|With 448 subjects with confirmed strokes or systemic emboli, study would have at least 90% power to meet both regulatory definitions of non-inferiority described in the following: (1) the non-inferiority (NI) of apixaban relative to warfarin was demonstrated if the upper bound of the two-sided 95% confidence interval (CI) for relative risk (RR) was less than 1.38; (2) the NI of apixaban relative to warfarin was demonstrated if the upper bound of the two-sided 99% CI for RR was less than 1.44.|
1743617|NCT00412971|3206987|Superiority or Other||difference in recurrence rate|0.25||||0.05|2-Sided|95.0|||||Cochran-Mantel-Haenszel||||
1743618|NCT00412958|3206988|Superiority or Other||Odds Ratio (OR)|3.28||||0.107|2-Sided|95.0|0.77|13.95|||Regression, Logistic|||P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.|
1743619|NCT00412958|3206988|Superiority or Other||Odds Ratio (OR)|1.81||||0.447|2-Sided|95.0|0.39|8.36|||Regression, Logistic|||P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.|
1743620|NCT00412958|3206988|Superiority or Other||Odds Ratio (OR)|1.24||||0.796|2-Sided|95.0|0.24|6.36|||Regression, Logistic|||P-values are from Wald chi-square tests from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.|
1743621|NCT00412932|3206992|Superiority or Other||||||<|0.0001||||||No multiplicity adjustments. The P-Value of <0.0001 applies to both daytime and nighttime periods.|one-sample t-test||||
1743622|NCT00412932|3206993|Superiority or Other||||||<|0.0001||||||No multiplicity adjustments. This P-Value applies to both the daytime and nighttime periods.|one-sample t-test||||
1743623|NCT00412932|3206994|Superiority or Other||||||<|0.0001|||||||One-sample t-test||||
1743624|NCT00412932|3206995|Superiority or Other||||||<|0.0001||||||No multiplicity adjustments|one-sample t-test|||The sample size of this study was not based on the statistical power consideration and was considered as sufficient for the evaluation of the efficacy and safety of the proposed olmesartan medoxomil-based treatment regimen.|
1743625|NCT00412893|3206997|Superiority or Other||Adjusted Treatment Difference|5.1|||||2-Sided|95.0|-6.187|16.332|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison|
1743626|NCT00412893|3206997|Superiority or Other||Adjusted Treatment Difference|8.0|||||2-Sided|95.0|-3.335|19.356|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison|
1743627|NCT00412893|3206997|Superiority or Other||Adjusted Treatment Difference|6.3|||||2-Sided|95.0|-5.145|17.696|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison|
1743628|NCT00412893|3206998|Superiority or Other||Adjusted Treatment Difference|2.9|||||2-Sided|95.0|-8.633|14.499|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison|
1743629|NCT00412893|3206998|Superiority or Other||Adjusted Treatment Difference|-2.5|||||2-Sided|95.0|-15.071|10.073|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison|
1743630|NCT00412893|3206998|Superiority or Other||Adjusted Treatment Difference|4.4|||||2-Sided|95.0|-8.429|17.218|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison|
1743631|NCT00412893|3206999|Superiority or Other||Adjusted treatment Difference|4.7|||||2-Sided|95.0|-6.533|15.939|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison|
1743632|NCT00412893|3206999|Superiority or Other||Adjusted treatment Difference|0.2|||||2-Sided|95.0|-10.873|11.22|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison|
1743633|NCT00412893|3206999|Superiority or Other||Adjusted Treatment Difference|5.0|||||2-Sided|95.0|-6.043|16.026|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison|
1743717|NCT00411749|3207145|Superiority or Other||Geometric Mean|155.2|||||2-Sided|95.0|126.2|190.9|||||||
1743718|NCT00411749|3207146|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1743635|NCT00412893|3207000|Superiority or Other||Adjusted Treatment Difference|5.3|||||2-Sided|95.0|-5.338|16.032|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison|
1743636|NCT00412893|3207000|Superiority or Other||Adjusted Treatment Difference|5.7|||||2-Sided|95.0|-4.936|16.268|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison|
1743637|NCT00412893|3207001|Superiority or Other||Adjusted Treatment Difference|9.1|||||2-Sided|95.0|-1.624|19.83|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 Comparison|
1743638|NCT00412893|3207001|Superiority or Other||Adjusted Treatment Difference|-0.7|||||2-Sided|95.0|-11.917|10.586|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 Comparison|
1743639|NCT00412893|3207001|Superiority or Other||Adjusted Treatment Difference|3.8|||||2-Sided|95.0|-7.429|15.087|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison|
1743640|NCT00412893|3207002|Superiority or Other||Adjusted Treatment Difference|0.3|||||2-Sided|95.0|-11.116|11.758|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison|
1743641|NCT00412893|3207002|Superiority or Other||Adjusted Treatment Difference|-5.8|||||2-Sided|95.0|-17.368|5.802|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison|
1743642|NCT00412893|3207002|Superiority or Other||Adjusted Treatment Difference|0.4|||||2-Sided|95.0|-10.64|11.531|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment Comparison|
1743643|NCT00412893|3207004|Superiority or Other||Adjusted Treatment Difference|-1.4|||||2-Sided|95.0|-9.15|6.34|||||The treatment difference (isavuconazole minus voriconazole) was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. The strata included Geographical Regions, Allogeneic BMT Status and Uncontrolled Malignancy Status.||
1743644|NCT00412893|3207005|Superiority or Other||Adjusted Treatment Difference|8.2|||||2-Sided|95.0|-1.993|18.379|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 84 comparison|
1743645|NCT00412893|3207005|Superiority or Other||Adjusted Treatment Difference|-0.5|||||2-Sided|95.0|-11.277|10.329|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Day 42 comparison|
1743646|NCT00412893|3207005|Superiority or Other||Adjusted Treatment Difference|1.6|||||2-Sided|95.0|-9.336|12.572|||||The adjusted treatment difference (Voriconazole-Isavuconazole) was calculated by a stratified CMH method with the strata of Geographical Region, Allogeneic BMT Status and Uncontrolled Malignancy Status.|End of Treatment comparison|
1743647|NCT00412893|3207006|Non-Inferiority or Equivalence|The upper bound of the 95% CI for the treatment difference was compared to the protocol prespecified non-inferiority margin of 10%. If the upper bound was smaller than 10%, isavuconazole was declared as non-inferior to voriconazole with respect to the primary outcome measure.|Adjusted Treatment Difference|-1.0|||||2-Sided|95.0|-7.759|5.683|||||The treatment difference (isavuconazole minus voriconazole) was calculated using a stratified Cochran-Mantel-Haenszel (CMH) method. The strata included Geographical Regions, Allogeneic BMT Status and Uncontrolled Malignancy Status.|Approximately 255 patients per group were to be enrolled to ensure at least 80% power to demonstrate that the upper bound of the 95% confidence interval (CI) for a treatment difference in favor of the comparator was no larger than 10%.|
1743648|NCT00412854|3207021|Non-Inferiority or Equivalence|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix+Hiberix Group minus Infanrix/Hib Group] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|1.23|||||2-Sided|95.0|-2.17|5.07||||||"Difference in vaccine response rates against PRN:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."|
1743649|NCT00412854|3207021|Non-Inferiority or Equivalence|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix+Hiberix Group minus Infanrix/Hib Group] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|0.0|||||2-Sided|95.0|-2.29|2.3||||||"Difference in vaccine response rates against FHA:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."|
1743650|NCT00412854|3207021|Non-Inferiority or Equivalence|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix+Hiberix Group minus Infanrix/Hib Group] in percentage of subjects with a vaccine response was ≤ 10%.|Difference in seroresponse rate|0.0|||||2-Sided|95.0|-2.29|2.3||||||"Difference in vaccine response rates against PT:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."|
1743719|NCT00411749|3207147|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1743651|NCT00412854|3207022|Non-Inferiority or Equivalence|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix+Hiberix Group minus Infanrix/Hib Group] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|2.47|||||2-Sided|95.0|0.15|6.18||||||"Difference in seroprotection rates against PRP:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."|
1743652|NCT00412854|3207023|Non-Inferiority or Equivalence|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix+Hiberix Group minus Infanrix/Hib Group] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-2.29|2.3||||||"Difference in seroprotection rates against tetanus toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose vaccination course."|
1743653|NCT00412854|3207023|Non-Inferiority or Equivalence|The upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix+Hiberix Group minus Infanrix/Hib Group] in percentage of seroprotected subjects was ≤ 10%.|Difference in seroprotection rate|0.61|||||2-Sided|95.0|-1.68|3.39||||||"Difference in seroprotection rates against diphteria toxoid:~To demonstrate that the immunogenicity of Infanrix™/Hib vaccine administered at 3, 4 and 5 months of age (Infanrix/Hib Group) was non-inferior to that of the concomitant administration of Infanrix™ and Hiberix™ vaccines at the same age (Infanrix+Hiberix Group), in terms of immune response to all vaccine antigens, one month after the three-dose primary vaccination course."|
1743654|NCT00412737|3207035|Superiority or Other||Relative Risk Reduction|0.502|||||2-Sided|95.0|-1.4|5.1|||||Relative Risk Reduction = (1.0 - Relative Risk).||
1743655|NCT00412737|3207036|Superiority or Other||Relative Risk Reduction|0.372|||||2-Sided|95.0|-1.9|4.6|||||Relative Risk Reduction = (1.0 - Relative Risk).||
1743656|NCT00412737|3207037|Superiority or Other||Slope|0.858|||||2-Sided|95.0|0.1|5.7|||||Relative Risk Reduction = (1.0 - Relative Risk).||
1743657|NCT00412737|3207038|Superiority or Other||Relative Risk Reduction|0.713|||||2-Sided|95.0|-0.6|5.2|||||Relative Risk Reduction = (1.0 - Relative Risk).||
1743658|NCT00412737|3207039|Superiority or Other||Relative Risk Reduction|0.431||||0.381|2-Sided|95.0|-1.7|4.6|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).||
1743659|NCT00412737|3207040|Superiority or Other||Relative Risk Reduction|0.37||||0.534|2-Sided|95.0|-2.1|4.5|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).||
1743660|NCT00412737|3207041|Superiority or Other||Relative Risk Reduction|0.283||||0.772|2-Sided|95.0|-2.3|4.1|||Fisher Exact||Relative Risk Reduction = (1.0 - Relative Risk).|The null hypothesis tested was that there was no difference between the proportions of participants who met the primary endpoint in the two treatment groups.|
1743661|NCT00412607|3207047|Superiority or Other||Percentage of mortality|13.3|||||1-Sided|95.0||17.5|||||The 95% confidence interval is a one-sided with upper confidence level = 17.5% computed using the exact binomial test.|"Assumptions for sample size calculation: 10% attrition rate, Type I error of 0.05, anticipated 12-month mortality rate is 0.19, a region of indifference of 0.07, power of 0.8; the required sample size is 249 per nQuery Exact test for single proportion method.~The null hypothesis is that the 12-month mortality rate is greater than or equal to 0.26; the alternative is that the rate is less than 0.26. This hypothesis is evaluated with one-sided exact binomial test at α= 0.05."|
1743662|NCT00412451|3207066|Superiority or Other||Odds Ratio (OR)|0.346||||0.372||95.0|0.07|1.703|||Fisher Exact||||
1743663|NCT00412451|3207066|Superiority or Other||Odds Ratio (OR)|0.562||||0.67|2-Sided|95.0|0.132|2.4|||Fisher Exact||||
1743664|NCT00412451|3207066|Superiority or Other||Odds Ratio (OR)|0.001||||0.131|2-Sided|95.0|0.001|999.999|||Fisher Exact||||
1743665|NCT00412373|3207068|Superiority or Other||LS Means Difference|-4.8|Standard Error of the Mean|1.5||0.001||95.0|-7.7|-2.0|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.||
1743666|NCT00412373|3207070|Superiority or Other||LS Means Difference|-4.1|Standard Error of the Mean|1.2|<|0.001||95.0|-6.4|-1.7|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.||
1743667|NCT00412373|3207072|Superiority or Other|||||||0.046|||||||Cochran-Mantel-Haenszel|P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.|||
1743668|NCT00412373|3207073|Superiority or Other||LS Means Difference|-0.6|Standard Error of the Mean|0.2|<|0.001||95.0|-0.9|-0.3|||ANOVA|P-value is from an ANOVA model with fixed effects for treatment, concomitant medication stratum, and country.|||
1743669|NCT00412373|3207074|Superiority or Other||LS Means Difference|-0.5|Standard Error of the Mean|0.1||0.002||95.0|-0.7|-0.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.||
1743670|NCT00412373|3207076|Superiority or Other||LS Means Difference|-1.0|Standard Error of the Mean|0.4||0.016||95.0|-1.8|-0.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.||
1743671|NCT00412373|3207077|Superiority or Other||LS Means Difference|-1.6|Standard Error of the Mean|0.5||0.001||95.0|-2.6|-0.6|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.||
1743672|NCT00412373|3207078|Superiority or Other||LS Means Difference|-1.9|Standard Error of the Mean|0.5|<|0.001||95.0|-2.9|-0.9|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.||
1743673|NCT00412373|3207079|Superiority or Other||LS Means Difference|-2.1|Standard Error of the Mean|0.6|<|0.001||95.0|-3.3|-0.9|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.||
1743674|NCT00412373|3207080|Superiority or Other||LS Means Difference|-2.7|Standard Error of the Mean|0.8|<|0.001||95.0|-4.2|-1.1|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.||
1743675|NCT00412373|3207081|Superiority or Other||LS Means Difference|-4.5|Standard Error of the Mean|1.2|<|0.001||95.0|-6.8|-2.3|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.||
1743676|NCT00412373|3207082|Superiority or Other||LS Means Difference|-2.0|Standard Error of the Mean|0.6|<|0.001||95.0|-3.1|-0.8|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.||
1743677|NCT00412373|3207083|Superiority or Other||LS Means Difference|-2.8|Standard Error of the Mean|0.8|<|0.001||95.0|-4.4|-1.2|||ANCOVA|P-value is from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and with baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.||
1743678|NCT00412373|3207084|Superiority or Other||LS Mean Difference|-9.4|Standard Error of the Mean|2.3|<|0.001||95.0|-13.8|-4.9|||ANCOVA|P-values are from an ANCOVA model with fixed effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) - Placebo on the Change Scores.||
1743679|NCT00412373|3207085|Superiority or Other||LS Mean Difference|0.5|Standard Error of the Mean|1.6||0.774||95.0|-2.7|3.7|||ANOVA|P-value based on the actual value and was from an ANOVA model with fixed effects for treatment, concomitant medication stratum, and country.|Paliperidone Extended Release (ER) - Placebo on the Actual Score.||
1743680|NCT00412360|3207087|Superiority|||||||0.43||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality between participants receiving single- and double-unit cord blood transplant.|
1743681|NCT00412360|3207088|Superiority|||||||0.12||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of relapse between participants receiving single- and double-unit cord blood transplant.|
1743682|NCT00412360|3207090|Superiority|||||||0.05||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of extensive chronic GVHD between participants receiving single- and double-unit cord blood transplant.|
1743683|NCT00412360|3207090|Superiority|||||||0.51||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD between participants receiving single- and double-unit cord blood transplant.|
1743684|NCT00412360|3207091|Superiority|||||||0.02||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of Grade III-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.|
1743685|NCT00412360|3207091|Superiority|||||||0.78||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of Grade II-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.|
1743686|NCT00412360|3207093|Superiority|||||||0.04||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment between participants receiving single- and double-unit cord blood transplant.|
1743687|NCT00412360|3207093|Superiority|||||||0.29||||||Testing was performed at a significance level of 0.05|Gray's test|||The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment between participants receiving single- and double-unit cord blood transplant.|
1743688|NCT00412360|3207094|Superiority|||||||0.11||||||Testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that there is no difference in disease-free survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant.|
1743689|NCT00412360|3207095|Superiority|||||||0.17||||||Testing was performed at a significance level of 0.05|Log Rank|||The null hypothesis is that there is no difference in overall survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant. The targeted sample size of 110 participants per treatment group was sufficient to maintain a type I error rate of 5% and provide more than 86% power to detect an increase in overall survival from 57% among participants receiving a single unit graft to 77% for those receiving a double-unit graft.|
1743690|NCT00412113|3207101|Superiority or Other||Difference in LS Means|-2.8|||<|0.001||95.0|-3.5|-2.1||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline to Week 6 in Framingham predicted absolute 10-year risk.|
1743691|NCT00412113|3207102|Superiority or Other||Difference in LS Means|-2.4|||<|0.001||95.0|-3.1|-1.7||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline to Week 4 in Framingham predicted absolute 10-year risk.|
1743692|NCT00412113|3207103|Superiority or Other||Difference in LS Means|-53.95|||<|0.001||95.0|-77.61|-30.29||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change in TG from baseline in at Week 6.|
1743693|NCT00412113|3207104|Superiority or Other||Difference in LS Means|-62.07|||<|0.001||95.0|-68.49|-55.65||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 6.|
1743720|NCT00411749|3207148|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1743694|NCT00412113|3207105|Superiority or Other||Difference in LS Means|-1.02||||0.329||95.0|-3.07|1.03||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 6.|
1743695|NCT00412113|3207106|Superiority or Other||Difference in LS Means|-51.21|||<|0.001||95.0|-56.88|-45.55||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 6.|
1743696|NCT00412113|3207107|Superiority or Other||Difference in LS Means|-47.27|||<|0.001||95.0|-63.37|-31.16||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TG at Week 4.|
1743697|NCT00412113|3207108|Superiority or Other||Difference in LS Means|-57.9|||<|0.001||95.0|-64.02|51.81||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in TC at Week 4.|
1743698|NCT00412113|3207109|Superiority or Other||difference in LS Means|-0.3||||0.739||95.0|-2.07|1.47||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in HDL at Week 4.|
1743699|NCT00412113|3207110|Superiority or Other||Difference in LS Means|-49.3|||<|0.001||95.0|-54.68|-43.91||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in LDL at Week 4.|
1743700|NCT00412113|3207111|Superiority or Other||Difference in LS Means|0.1||||0.922||95.0|-1.91|2.11||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in mean change from baseline in pulse rate at Week 6.|
1743701|NCT00412113|3207112|Superiority or Other||Difference in LS Means|-0.87||||0.351||95.0|-2.71|0.97||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 6.|
1743702|NCT00412113|3207113|Superiority or Other||Difference in LS means|-3.25||||0.02||95.0|-5.99|-0.51||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 6.|
1743703|NCT00412113|3207114|Superiority or Other||Difference in LS Means|-0.9||||0.363||95.0|-2.83|1.04|||ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in pulse rate at Week 4.|
1743704|NCT00412113|3207115|Superiority or Other||Difference in LS Means|0.0|||>|0.999||95.0|-2.01|2.01||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in diastolic blood pressure at Week 4.|
1743705|NCT00412113|3207116|Superiority or Other||Difference in LS Means|0.76||||0.585||95.0|-1.97|3.48||No adjustment for p-value for secondary analyses|ANCOVA|||Null hypothesis: There is no difference between the two treatment management strategies in the mean change from baseline in systolic blood pressure at Week 4.|
1743706|NCT00412113|3207117|Superiority or Other||Odds Ratio (OR)|1.55||||0.171||95.0|0.83|2.88||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (< 140/90 mmHg) at Week 6.|
1743707|NCT00412113|3207118|Superiority or Other||Odds Ratio (OR)|1.09||||0.785||95.0|0.6|1.98||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving blood pressure (< 140/90 mmHg)at Week 4|
1743708|NCT00412113|3207119|Superiority or Other||Odds Ratio (OR)|42.04|||<|0.001||95.0|19.42|90.99||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving LDL-goal (<100mg/DL) at Week 6.|
1743709|NCT00412113|3207120|Superiority or Other||Odds Ratio (OR)|65.51|||<|0.001||95.0|27.1|158.34||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving (<100mg/DL) at Week 4.|
1743710|NCT00412113|3207121|Superiority or Other||Odds Ratio (OR)|5.14|||<|0.001||95.0|2.89|9.11||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (< 140/90 mmHg) and LDL-goal (<130mg/dL) at Week 6.|
1743711|NCT00412113|3207122|Superiority or Other||Odds Ratio (OR)|5.2|||<|0.001||95.0|2.93|9.24||No adjustment for p-value for secondary analyses|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (< 140/90 mmHg) and LDL-goal (<130mg/dL) at Week 4.|
1743712|NCT00412113|3207123|Superiority or Other||Odds Ratio (OR)|31.39|||<|0.001||95.0|12.61|78.09||No adjustment for p-value for secondary analysis|Cochran-Mantel-Haenszel|||Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the blood pressure (< 140/90 mmHg) and LDL-goal (<100 mg/dL) at Week 4.|
1743713|NCT00412113|3207124|Superiority or Other||Odds Ratio (OR)|19.03|||<|0.001||95.0|9.14|39.63||There was only one primary endpoint and the p-value was not adjusted for comparison.|Cochran-Mantel-Haenszel|||"Null hypothesis: There is no difference between the two treatment management strategies in the percentage of patients achieving both the BP(< 140/90 mmHg) and LDL goal (< 100mg/dL) at Week 6.~With ~120 in each treatment arm, planned power was at least 90% to detect a difference between treatments, assuming 35% in the Caduet and 15% in the Norvasc arm achieving BP <140/90 mmHg and LDL <100 mg/dL and using a chi-square test with 0.05 two-sided significance level."|
1743714|NCT00411749|3207145|Superiority or Other||Geometric Mean|90.0|||||2-Sided|95.0|68.8|117.8|||||||
1743715|NCT00411749|3207145|Superiority or Other||Geometric Mean|617.1|||||2-Sided|95.0|491.7|774.5|||||||
1743716|NCT00411749|3207145|Superiority or Other||Geometric Mean|198.2|||||2-Sided|95.0|160.9|244.2|||||||
1743722|NCT00411645|3207156|Superiority or Other||Odds Ratio (OR)|0.726||||0.1019|2-Sided|95.0|0.495|1.066||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 6 months post-transplant|
1743723|NCT00411645|3207156|Superiority or Other||Odds Ratio (OR)|1.186||||0.6304|2-Sided|95.0|0.592|2.375||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 100 days post-transplant|
1743724|NCT00411645|3207157|Superiority or Other||Odds Ratio (OR)|1.068||||0.6946|2-Sided|95.0|0.771|1.479||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 6 months post-transplant|
1743725|NCT00411645|3207157|Superiority or Other||Odds Ratio (OR)|1.048||||0.7808|2-Sided|95.0|0.754|1.457||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R -) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 100 days post-transplant|
1743726|NCT00411645|3207158|Superiority or Other||Odds Ratio (OR)|0.835||||0.617|2-Sided|95.0|0.411|1.693||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of 12 months post-transplant|
1743727|NCT00411645|3207159|Superiority or Other||Odds Ratio (OR)|0.913||||0.86|2-Sided|95.0|0.332|2.508||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of EC-confirmed disease|
1743728|NCT00411645|3207159|Superiority or Other||Odds Ratio (OR)|0.731||||0.069|2-Sided|95.0|0.521|1.026||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of initiation of anti-CMV therapy|
1743729|NCT00411645|3207159|Superiority or Other||Odds Ratio (OR)|0.772||||0.125|2-Sided|95.0|0.555|1.075||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay or CMV DNA PCR assay|
1743730|NCT00411645|3207159|Superiority or Other||Odds Ratio (OR)|0.878||||0.468|2-Sided|95.0|0.617|1.247||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of CMV DNA PCR assay|
1743731|NCT00411645|3207159|Superiority or Other||Odds Ratio (OR)|0.669||||0.022|2-Sided|95.0|0.474|0.946||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay|
1743732|NCT00411645|3207160|Superiority or Other|||||||0.825||||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 12 months post-transplant|
1743733|NCT00411645|3207160|Superiority or Other|||||||0.637||||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 6 months post-transplant|
1743734|NCT00411645|3207160|Superiority or Other|||||||0.542||||||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel|||Analysis of 100 days post-transplant|
1743735|NCT00411645|3207161|Superiority or Other||Adjusted hazard ratio|0.83||||0.13|2-Sided|95.0|0.65|1.06||The p-value from Wald Chi-Square test for treatment effect.|Wald Chi-squared||Maribavir versus placebo; based on Cox’s proportional hazards regression model: time = recipient CMV serostatus (R+ or R-) + transplant type (myeloablative or non-myeloablative/reduced intensity) + treatment.||
1743736|NCT00411645|3207161|Superiority or Other|||||||0.129|||||||Log Rank||||
1743737|NCT00411645|3207162|Superiority or Other||Odds Ratio (OR)|0.891||||0.493|2-Sided|95.0|0.64|1.239||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of initiation of anti-CMV therapy|
1743738|NCT00411645|3207162|Superiority or Other||Odds Ratio (OR)|0.838||||0.289|2-Sided|95.0|0.606|1.161||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia or CMV DNA PCR assay|
1743739|NCT00411645|3207162|Superiority or Other||Odds Ratio (OR)|0.979||||0.904|2-Sided|95.0|0.697|1.375||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of CMV DNA PCR assay|
1743740|NCT00411645|3207162|Superiority or Other||Odds Ratio (OR)|0.721||||0.056|2-Sided|95.0|0.515|1.008||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo|Analysis of pp65 antigenemia assay|
1743818|NCT00410072|3207413|Superiority or Other||Mean Difference (Final Values)|-4.1|||||2-Sided|95.0|-13.8|5.6||||||Analysis at Week 48|
1743819|NCT00410072|3207414|Superiority or Other||Mean Difference (Final Values)|-9.2|||||2-Sided|95.0|-20.6|2.3||||||Analysis at Week 96|
1743741|NCT00411645|3207163|Superiority or Other||Odds Ratio (OR)|0.902||||0.789|2-Sided|95.0|0.424|1.92||The p-value is from the Cochran-Mantel-Haenszel test, adjusting for recipient CMV serostatus (R+ or R-) and transplant type (myeloablative or non-myeloablative/reduced intensity).|Cochran-Mantel-Haenszel||Mantel-Haenszel odds ratio for maribavir versus placebo||
1743742|NCT00411554|3207167|Superiority or Other||Least-squares Mean Difference|-18.8|||<|0.001||95.0|-26.7|-10.9|||ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show superiority to voglibose and to estimate difference of two groups and its 95% confidence interval||
1743743|NCT00411554|3207168|Superiority or Other||Least-squares Mean Difference|-10.7|||<|0.001||95.0|-15.3|-6.2|||ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show superiority to voglibose and to estimate difference of two groups and its 95% confidence interval||
1743744|NCT00411554|3207169|Non-Inferiority or Equivalence|Non-inferiority margin (Sitagliptin minus Voglibose) = 0.2 percent|Least-squares Mean Difference|-0.39|||<|0.001||95.0|-0.51|-0.28||"This p-value corresponds to a test of superiority that was performed after success was achieved in the test of non-inferiority (reported under Estimation below), according to the pre-specified analysis plan"|ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to compare two groups|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to show non-inferiority and superiority to voglibose (closed procedure) and to estimate difference of two groups and its 95% confidence interval||
1743745|NCT00411450|3207177|Superiority or Other||Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.5|1.2|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).||
1743746|NCT00411450|3207178|Superiority or Other||Hazard Ratio (HR)|0.7|||||2-Sided|95.0|0.5|1.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).||
1743747|NCT00411450|3207179|Superiority or Other||Hazard Ratio (HR)|0.6|||||2-Sided|95.0|0.4|0.9|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).||
1743748|NCT00411450|3207180|Superiority or Other||Hazard Ratio (HR)|0.7|||||2-Sided|95.0|0.2|2.0|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).||
1743749|NCT00411450|3207181|Superiority or Other||Difference|6.0|||||2-Sided|95.0|-14.0|25.0||||||Difference at Week 25|
1743750|NCT00411450|3207181|Superiority or Other||Difference|6.0|||||2-Sided|95.0|-14.0|25.0|||||Difference = Wild type - Mutant|Difference at Week 17|
1743751|NCT00411450|3207182|Superiority or Other||Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.5|1.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with only KRAS effect (Wild type vs. Mutant).||
1743752|NCT00411450|3207183|Superiority or Other||Difference|10.9|||||2-Sided|95.0|-8.4|30.2||||||Difference at Week 25|
1743753|NCT00411450|3207183|Superiority or Other||Difference|12.5|||||2-Sided|95.0|-6.3|31.4|||||Difference = Wild type - Mutant|Difference at Week 17|
1743754|NCT00411450|3207184|Superiority or Other||Difference|7.0|||||2-Sided|95.0|-11.0|23.0|||||Difference = Wild type - Mutant||
1743755|NCT00411450|3207186|Superiority or Other||Difference|8.0|||||2-Sided|95.0|-9.0|23.0||||||Difference at Week 25|
1743756|NCT00411450|3207186|Superiority or Other||Difference|6.0|||||2-Sided|95.0|-11.0|21.0|||||Difference = Wild type - Mutant|Difference at Week 17|
1743757|NCT00410514|3207257|Non-Inferiority or Equivalence|The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.|LS Mean Difference|-1.39|||||2-Sided|95.0|-9.73|6.96|||||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.|
1743758|NCT00410514|3207257|Non-Inferiority or Equivalence|The non-inferiority margin was 15 cmH2O for PdetQmax. Mirabegron was considered non-inferior to placebo for PdetQmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was less than 15 cmH2O.|LS Mean Difference|-5.94|||||2-Sided|95.0|-13.98|2.09|||||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.|
1743759|NCT00410514|3207259|Non-Inferiority or Equivalence|The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.|LS Mean Difference|0.62|||||2-Sided|95.0|-0.43|1.68|||||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.|
1743820|NCT00410072|3207414|Superiority or Other||Mean Difference (Final Values)|-5.8|||||2-Sided|95.0|-15.9|4.2||||||Analysis at Week 48|
1743964|NCT00408876|3207588|Superiority or Other||Mean Difference (Net)|-0.52||||0.245||95.0|-1.39|0.36|||t-test, 2 sided||||
1743760|NCT00410514|3207259|Non-Inferiority or Equivalence|The non-inferiority margin was -3 mL/sec for Qmax. Mirabegron was considered non-inferior to placebo for Qmax if the lower limit of the 2-sided 95% confidence interval (CI) for the difference from placebo was greater than -3 mL/sec.|LS Mean Difference|0.4|||||2-Sided|95.0|-0.63|1.42|||||Treatment groups were compared using ANCOVA with pooled center and treatment as factors and the baseline value as a covariate. Centers with less than 12 patients were pooled before the analysis.|The study was designed to show non-inferiority of mirabegron compared to placebo for both primary outcome measures. The comparison between mirabegron 50 mg and placebo was conducted first. If non-inferiority was demonstrated in this comparison, mirabegron 100 mg was compared to placebo. However, if the first comparison did not demonstrate non-inferiority, no further comparison was made. This procedure maintained the overall type I error of one-sided 2.5%.|
1743761|NCT00410410|3207307|Superiority or Other|||||||0.149||||||All statistical testing was performed at a pre-specified alpha-level of 5%|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.|
1743762|NCT00410410|3207313|Superiority or Other|||||||0.044||||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms.|
1743763|NCT00410410|3207314|Superiority or Other||Risk Ratio (RR)|0.66|||||2-Sided|95.0|0.42|1.05|||||Conditional on both the comparison for mucosal healing for ABA 30/~10 vs PLA and the comparison for remission for ABA ~10 vs. PLA being significant, the comparison for mucosal healing for ABA ~10 vs PLA will be tested at 5%.|Null hypothesis=no treatment difference (relative risk [RR] of ABA over placebo=1) for mucosal healing. ABA 30/~10 vs. placebo: power=99%, sample size=140 per arm, expected PLA response rate=30%, ABA 30/~10 mg/kg=60%. ABA ~10 vs. placebo: power=98%, sample size=140 per arm, 5% significance; expected PLA response rate= 30%, ABA ~10 mg/kg=55%|
1743764|NCT00410410|3207315|Superiority or Other||Risk Ratio (RR)|0.2|||||2-Sided|95.0|0.06|0.67|||||Conditional on both the remission comparison for ABA 30/~10 vs PLA, and the clinical response comparison for ABA~10 vs PLA being significant at 5%, the secondary remission comparison for ABA ~10 vs PLA will be tested at 5%.|Null hypothesis=no treatment difference between each of the ABA and placebo (PLA). At 5% significance level, Aba 30/~10 vs. PLA: power=96%, sample size=140 per arm, expected PLA rate=15%. ABA 30/~10 =35%; Aba ~10 vs. PLA: power=82%, sample size=140 per arm, expected PLA response rate= 15%, ABA/~10 mg/kg=30%|
1743765|NCT00410410|3207317|Superiority or Other||Risk Ratio (RR)|0.73||||0.124|2-Sided|95.0|0.48|1.09||Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata (whether a participant had an inadequate response and/or intolerance to anti-TNF therapy).|Cochran-Mantel-Haenszel|Conditional on ABA 30/~10 mg/kg vs PLA comparison being statistically significant at 5% level, ABA ~10 vs PLA to be tested at 5% significance level.||Null hypothesis=no treatment difference between ABA arm and placebo (PLA) arm. ABA 30/~10 mg/kg vs PLA: power=98%, sample size=140 per arm,expected PLA response rate=40%, ABA 30/~10 mg/kg=65%. ABA ~10 mg/kg vs. PLA: power=90%, sample size=140 per arm, 5% significance; expected PLA response rate= 40%, ABA ~10=60%.|
1743766|NCT00410384|3207319|Superiority or Other||Odds Ratio (OR)|1.56||||0.2081|2-Sided|95.0|0.78|3.13|||Regression, Logistic|Analysis was adjusted for baseline prednisone dose and baseline stratification factors.|||
1743767|NCT00410384|3207319|Superiority or Other||Odds Ratio (OR)|1.34||||0.4253|2-Sided|95.0|0.65|2.74|||Regression, Logistic|Analysis was adjusted for baseline prednisone dose and baseline stratification factors.|||
1743768|NCT00410384|3207320|Superiority or Other|||||||0.3762|||||||ANCOVA|Analysis adjusted for baseline PCS and baseline stratification factors.|||
1743769|NCT00410384|3207320|Superiority or Other|||||||0.6583|||||||ANCOVA|Analysis adjusted for baseline PCS and baseline stratification factors.|||
1743770|NCT00410384|3207321|Superiority or Other|||||||0.9703|||||||ANCOVA|Adjusted for baseline PGA and baseline stratification factors.|||
1743771|NCT00410384|3207321|Superiority or Other|||||||0.7962|||||||ANCOVA|Adjusted for baseline PGA and baseline stratification factors.|||
1743772|NCT00410384|3207322|Superiority or Other||Odds Ratio (OR)|1.38||||0.074|2-Sided|95.0|0.97|1.96|||Regression, Logistic|Adjusted for baseline stratification factors.|||
1743773|NCT00410384|3207322|Superiority or Other||Odds Ratio (OR)|1.63||||0.0063|2-Sided|95.0|1.15|2.32|||Regression, Logistic|Adjusted for baseline stratification factors.|||
1743774|NCT00410384|3207323|Superiority or Other||Odds Ratio (OR)|1.34||||0.105|2-Sided|95.0|0.94|1.91|||Regression, Logistic||Analysis was adjusted for baseline stratification factors.||
1743775|NCT00410384|3207323|Superiority or Other||Odds Ratio (OR)|1.31||||0.1323|2-Sided|95.0|0.92|1.87|||Regression, Logistic|Analysis was adjusted for baseline stratification factors.|||
1743776|NCT00410384|3207324|Superiority or Other||Odds Ratio (OR)|1.36||||0.0889|2-Sided|95.0|0.95|1.94||After superiority of 10 mg/kg vs placebo was established, the 1 mg/kg group was tested vs placebo (2-sided alpha=0.05)|Regression, Logistic|Adjusted for baseline stratification factors.|||
1743777|NCT00410384|3207324|Superiority or Other||Odds Ratio (OR)|1.54||||0.0167|2-Sided|95.0|1.08|2.19||For the primary analysis of the primary efficacy endpoint, a step-down sequential testing procedure was used to control the type 1 error.|Regression, Logistic|Adjusted for baseline stratification factors (SELENA SLEDAI Score: ≤9 vs ≥10; proteinuria: <2g vs ≥2g per 24hr; Race: African/indig-American vs Other)|||
1743778|NCT00410280|3207339|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.528|2-Sided|95.0|-1.14|0.59|||Mixed Models Analysis|||Day 35: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.|
1743779|NCT00410280|3207339|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9995|2-Sided|95.0|-0.86|0.86|||Mixed Models Analysis|||Day 14: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.|
1743780|NCT00410280|3207339|Superiority or Other||Mean Difference (Final Values)|0.09||||0.8469|2-Sided|95.0|-0.79|0.96|||Mixed Models Analysis|||Screening: Mixed model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participants was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-values were derived from the model.|
1743781|NCT00410280|3207340|Superiority or Other||Mean Difference (Final Values)|-13.19||||0.1289|2-Sided|95.0|-30.34|3.97|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.|
1743782|NCT00410280|3207340|Superiority or Other||Mean Difference (Final Values)|-19.05||||0.0302|2-Sided|95.0|-36.21|-1.9|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.|
1743783|NCT00410280|3207341|Superiority or Other||Mean Difference (Final Values)|-4.06||||0.3902|2-Sided|95.0|-13.46|5.35|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.|
1743784|NCT00410280|3207341|Superiority or Other||Mean Difference (Final Values)|-9.76||||0.0423|2-Sided|95.0|-19.16|-0.35|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.|
1743785|NCT00410280|3207342|Superiority or Other||Mean Difference (Final Values)|-17.17||||0.1326|2-Sided|95.0|-39.72|5.39|||ANOVA|||Day 35: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.|
1743786|NCT00410280|3207342|Superiority or Other||Mean Difference (Final Values)|-23.8||||0.0391|2-Sided|95.0|-46.35|-1.24|||ANOVA|||Day 14: Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.|
1743787|NCT00410280|3207343|Superiority or Other||Mean Difference (Final Values)|-4.24||||0.2673|2-Sided|95.0|-11.84|3.35|||ANOVA|||Repeated measures ANOVA model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95% CI and p-value were derived from the model.|
1743788|NCT00410280|3207344|Superiority or Other||Mean Difference (Final Values)|-6.44||||0.0947|2-Sided|95.0|-14.04|1.15|||ANOVA|||Repeated measures analysis of variance (ANOVA) model with fixed effects for treatment, time and interaction between treatment and time, and random effects for participant was used. Point estimate for difference between the treatment groups, corresponding 95 % confidence interval (CI) and p-value were derived from the model.|
1743789|NCT00410202|3207352|Superiority or Other||Difference Estimate|0.7|||||2-Sided|95.0|-0.7|2.1|||||||
1743790|NCT00410202|3207352|Superiority or Other||Difference Estimate|0.7|||||2-Sided|95.0|-0.7|2.1|||||||
1743791|NCT00410202|3207354|Superiority or Other||Difference Estimate|0.0|||||2-Sided|95.0|-2.0|2.0|||||||
1743792|NCT00410202|3207354|Superiority or Other||Difference Estimate|0.7|||||2-Sided|95.0|-0.7|2.1|||||||
1743793|NCT00410202|3207355|Superiority or Other||Difference Estimate|2.1|||||2-Sided|95.0|-3.6|7.8|||||||
1743794|NCT00410202|3207356|Superiority or Other||Difference Estimate|1.4|||||2-Sided|95.0|-3.5|6.2|||||||
1743795|NCT00410202|3207356|Superiority or Other||Difference Estimate|2.2|||||2-Sided|95.0|-2.4|6.8|||||||
1743796|NCT00410202|3207357|Superiority or Other||Difference Estimate|-1.5|||||2-Sided|95.0|-9.5|6.4|||||||
1743797|NCT00410202|3207358|Superiority or Other||Difference Estimate|1.3|||||2-Sided|95.0|-4.6|7.2|||||||
1743798|NCT00410202|3207358|Superiority or Other||Difference Estimate|0.8|||||2-Sided|95.0|-5.2|6.7|||||||
1743799|NCT00410202|3207359|Superiority or Other||Difference Estimate|-2.8|||||2-Sided|95.0|-16.2|10.6|||||||
1743800|NCT00410202|3207360|Superiority or Other||Difference Estimate|-1.2|||||2-Sided|95.0|-15.0|12.6|||||||
1743801|NCT00410202|3207360|Superiority or Other||Difference Estimate|-2.4|||||2-Sided|95.0|-15.5|10.7|||||||
1743802|NCT00410202|3207362|Superiority or Other||Difference Estimate|-0.55|||||2-Sided|95.0|-0.824|-0.281|||||||
1743803|NCT00410202|3207362|Superiority or Other||Difference Estimate|-1.26|||||2-Sided|95.0|-1.534|-0.994|||||||
1743804|NCT00410202|3207365|Superiority or Other||Difference estimate|12.9|||||2-Sided|95.0|2.4|23.4|||||||
1743805|NCT00410202|3207366|Superiority or Other||Difference Estimate|8.6|||||2-Sided|95.0|-0.1|17.3|||||||
1743806|NCT00410202|3207366|Superiority or Other||Difference Estimate|8.9|||||2-Sided|95.0|0.3|17.4|||||||
1743807|NCT00410202|3207367|Superiority or Other||Difference estimate|12.9|||||2-Sided|95.0|1.8|23.9|||||||
1743808|NCT00410202|3207368|Superiority or Other||Difference Estimate|8.6|||||2-Sided|95.0|-1.1|18.2|||||||
1743809|NCT00410202|3207368|Superiority or Other||Difference Estimate|11.8|||||2-Sided|95.0|2.5|21.1|||||||
1743810|NCT00410202|3207369|Superiority or Other||Difference estimate|15.0||||0.0095|2-Sided|95.0|3.7|26.4|||Hochberg procedure||||
1743811|NCT00410202|3207370|Superiority or Other||Difference Estimate|5.7||||0.2619|2-Sided|95.0|-4.2|15.5|||Hochberg procedure||||
1743812|NCT00410202|3207370|Superiority or Other||Difference Estimate|8.9||||0.1336|2-Sided|95.0|-2.0|19.9|||Hochberg procedure||||
1743813|NCT00410072|3207411|Superiority or Other||Mean Difference (Final Values)|1.3|||||2-Sided|95.0|-2.3|4.9||||||Analysis at Week 96|
1743814|NCT00410072|3207411|Superiority or Other||Mean Difference (Final Values)|-0.1|||||2-Sided|95.0|-2.2|2.0||||||Analysis at Week 48|
1744078|NCT00408876|3207607|Superiority or Other|||||||0.128|||||||Repeated Measures||||
1743821|NCT00410072|3207415|Superiority or Other||Mean Difference (Final Values)|-12.8|||||2-Sided|95.0|-21.5|-4.1||||||Analysis at Week 96. The stratified analysis is based on HBeAg strata at randomization.|
1743822|NCT00410072|3207415|Superiority or Other||Mean Difference (Final Values)|-10.4|||||2-Sided|95.0|-18.8|-2.0||||||Analysis at Week 48. The stratified analysis is based on HBeAg strata at randomization.|
1743823|NCT00410072|3207417|Superiority or Other||Mean Difference (Final Values)|8.6|||||2-Sided|95.0|-0.2|17.3||||||Analysis at Week 96. The stratified analysis was based on HBeAg strata at randomization.|
1743824|NCT00410072|3207417|Superiority or Other||Mean Difference (Final Values)|7.8|||||2-Sided|95.0|-1.5|17.1||||||Analysis at Week 48. The stratified analysis was based on HBeAg strata at randomization.|
1743825|NCT00410072|3207418|Superiority or Other||Mean Difference (Final Values)|7.1|||||2-Sided|95.0|-1.1|15.2||||||Analysis at week 96. The stratified analysis was based on HBeAg strata at randomization.|
1743826|NCT00410072|3207418|Superiority or Other||Mean Difference (Final Values)|7.1|||||2-Sided|95.0|-1.8|16.0||||||Analysis at week 48. The stratified analysis was based on HBeAg strata at randomization.|
1743827|NCT00410072|3207419|Superiority or Other||Mean Difference (Final Values)|-1.2|||||2-Sided|95.0|-12.0|9.5|||||||
1743828|NCT00410072|3207419|Superiority or Other||Mean Difference (Final Values)|10.6||||0.046|2-Sided|95.0|0.2|21.0|||Cochran-Mantel-Haenszel||||
1743829|NCT00410072|3207419|Superiority or Other||Mean Difference (Final Values)|2.2|||||2-Sided|95.0|-7.7|12.0|||||||
1743830|NCT00410072|3207419|Superiority or Other||Mean Difference (Final Values)|13.5|||||2-Sided|95.0|2.3|24.8|||||||
1743831|NCT00410072|3207420|Superiority or Other||Mean Difference (Final Values)|6.9||||0.0882|2-Sided|95.0|-1.0|14.9|||Cochran-Mantel-Haenszel|||Week 96|
1743832|NCT00410046|3207426|Superiority or Other|||||||0.576||||||Comparison of Sick leave 48 weeks before treatment Vs. Sick leave during 48 weeks of treatment|Fisher Exact||||
1743833|NCT00410046|3207427|Superiority or Other|||||||0.091||||||Comparison of Out-patient physician 48 weeks before treatment Vs. Out-patient physician during 48 treatment weeks|Fisher Exact||||
1743834|NCT00410046|3207427|Superiority or Other|||||||0.005||||||Comparison of Visit to physiotherapist 48 weeks before treatment Vs. Visit to physiotherapist during 48 treatment weeks|Fisher Exact||||
1743835|NCT00410046|3207427|Superiority or Other|||||||0.362||||||Comparison of Therapeutic warm bath 48 weeks before treatment Vs. Therapeutic warm bath during 48 treatment weeks|Fisher Exact|||Comparison of percentages|
1743836|NCT00410046|3207427|Superiority or Other|||||||0.743||||||Comparison of Hospitalization 48 weeks before treatment Vs. Hospitalization during 48 treatment weeks|Fisher Exact||||
1743837|NCT00410046|3207432|Superiority or Other|||||||0.906|||||||ANCOVA||||
1743838|NCT00410046|3207433|Superiority or Other|||||||1|||||||Fisher Exact|||Analysis completed for patients with sick leave during the past 12 months|
1743839|NCT00410046|3207434|Superiority or Other|||||||0.816|||||||ANCOVA|||Out-patient physician visit per patient|
1743840|NCT00410046|3207434|Superiority or Other|||||||0.361|||||||ANCOVA|||Physiotherapist visits per patient|
1743841|NCT00410046|3207434|Superiority or Other|||||||0.045|||||||ANCOVA|||Therapeutic warm bath sessions per patient|
1743842|NCT00410046|3207434|Superiority or Other|||||||0.628|||||||ANCOVA|One-way ANCOVA, baseline was a covariate.||Inpatient hospitalization days per patient|
1743843|NCT00410046|3207435|Superiority or Other|||||||0.475|||||||Fisher Exact|||Out-patient physician visit|
1743844|NCT00410046|3207435|Superiority or Other|||||||0.567|||||||Fisher Exact|||Physiotherapist visits|
1743845|NCT00410046|3207435|Superiority or Other|||||||0.23|||||||Fisher Exact|||Therapeutic warm bath sessions|
1743846|NCT00410046|3207435|Superiority or Other|||||||1|||||||Fisher Exact|||Admissions to hospital|
1743847|NCT00409773|3207471|Superiority or Other||Median Difference (Final Values)|2.3||||0.41||95.0|-5.1|9.6|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum|||
1743848|NCT00409773|3207471|Superiority or Other||Median Difference (Final Values)|-0.9||||0.555||95.0|-9.5|7.2|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum|||
1743849|NCT00409773|3207471|Superiority or Other||Median Difference (Final Values)|-2.9||||0.42||95.0|-11.0|5.0|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum|||
1743850|NCT00409773|3207474|Superiority or Other||Mean Difference (Final Values)|-7.7|Standard Error of the Mean|1.8|<|0.001||95.0|-11.2|-4.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743851|NCT00409773|3207474|Superiority or Other||Mean Difference (Final Values)|-7.0|Standard Error of the Mean|1.8|<|0.001||95.0|-10.4|-3.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743852|NCT00409773|3207474|Superiority or Other||Mean Difference (Final Values)|-11.5|Standard Error of the Mean|1.8|<|0.001||95.0|-15.0|-8.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743853|NCT00409773|3207475|Superiority or Other||Mean Difference (Final Values)|-5.7|Standard Error of the Mean|1.5|<|0.001||95.0|-8.7|-2.7|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743854|NCT00409773|3207475|Superiority or Other||Mean Difference (Final Values)|-6.4|Standard Error of the Mean|1.5|<|0.001||95.0|-9.4|-3.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743855|NCT00409773|3207475|Superiority or Other||Mean Difference (Final Values)|-11.0|Standard Error of the Mean|1.5|<|0.001||95.0|-14.0|-8.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743856|NCT00409773|3207476|Superiority or Other||Mean Difference (Final Values)|-8.5|Standard Error of the Mean|1.8|<|0.001||95.0|-12.0|-4.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743857|NCT00409773|3207476|Superiority or Other||Mean Difference (Final Values)|-9.7|Standard Error of the Mean|1.8|<|0.001||95.0|-13.2|-6.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743858|NCT00409773|3207476|Superiority or Other||Mean Difference (Final Values)|-14.0|Standard Error of the Mean|1.8|<|0.001||95.0|-17.6|-10.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1744079|NCT00408876|3207607|Superiority or Other||||||<|0.001|||||||Repeated Measures||||
1743859|NCT00409773|3207477|Superiority or Other||Mean Difference (Final Values)|-5.9|Standard Error of the Mean|1.4|<|0.001||95.0|-8.7|-3.1|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743860|NCT00409773|3207477|Superiority or Other||Mean Difference (Final Values)|-5.3|Standard Error of the Mean|1.4|<|0.001||95.0|-8.2|-2.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743861|NCT00409773|3207477|Superiority or Other||Mean Difference (Final Values)|-8.8|Standard Error of the Mean|1.4|<|0.001||95.0|-11.6|-6.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743862|NCT00409773|3207478|Superiority or Other||Mean Difference (Final Values)|1.6|Standard Error of the Mean|1.2|<|0.001||95.0|-7.0|4.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743863|NCT00409773|3207478|Superiority or Other||Mean Difference (Final Values)|2.2|Standard Error of the Mean|1.2|<|0.001||95.0|-0.2|4.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743864|NCT00409773|3207478|Superiority or Other||Mean Difference (Final Values)|2.4|Standard Error of the Mean|1.2|<|0.042||95.0|0.1|4.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743865|NCT00409773|3207479|Superiority or Other||Mean Difference (Final Values)|-5.3|Standard Error of the Mean|1.4|<|0.001||95.0|-8.0|-2.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743866|NCT00409773|3207479|Superiority or Other||Mean Difference (Final Values)|-5.3|Standard Error of the Mean|1.4|<|0.001||95.0|-8.1|-2.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743867|NCT00409773|3207479|Superiority or Other||Mean Difference (Final Values)|-9.4|Standard Error of the Mean|1.4|<|0.001||95.0|-12.1|-6.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743868|NCT00409773|3207480|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|2.6||0.796||95.0|-5.8|4.4|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743869|NCT00409773|3207480|Superiority or Other||Mean Difference (Final Values)|3.2|Standard Error of the Mean|2.6||0.217||95.0|-1.9|8.4|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743870|NCT00409773|3207480|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|2.6||0.809||95.0|-5.7|4.5|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743871|NCT00409773|3207481|Superiority or Other||Mean Difference (Final Values)|-6.9|Standard Error of the Mean|1.5|<|0.001||95.0|-9.9|-3.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743872|NCT00409773|3207481|Superiority or Other||Mean Difference (Final Values)|-7.3|Standard Error of the Mean|1.5|<|0.001||95.0|-10.2|-4.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743873|NCT00409773|3207481|Superiority or Other||Mean Difference (Final Values)|-10.3|Standard Error of the Mean|1.5|<|0.001||95.0|-13.3|-7.3|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743874|NCT00409773|3207482|Superiority or Other||Mean Difference (Final Values)|4.0|Standard Error of the Mean|1.3||0.003||95.0|1.3|6.6|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743875|NCT00409773|3207482|Superiority or Other||Mean Difference (Final Values)|1.2|Standard Error of the Mean|1.3||0.378||95.0|-1.5|3.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743876|NCT00409773|3207482|Superiority or Other||Mean Difference (Final Values)|3.4|Standard Error of the Mean|1.3||0.013||95.0|0.7|6.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743877|NCT00409773|3207483|Superiority or Other||Median Difference (Final Values)|-0.4||||0.48||95.0|-4.7|3.9|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum|||
1743878|NCT00409773|3207483|Superiority or Other||Median Difference (Final Values)|2.8||||0.2||95.0|-1.6|7.1|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum|||
1743879|NCT00409773|3207483|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.69||95.0|-5.4|3.3|||Non-parametric ANOVA|ANOVA using normal scores (Tukey method) based on ranks with terms for treatment and baseline risk stratum|||
1743880|NCT00409773|3207484|Superiority or Other||Mean Difference (Final Values)|-4.4|Standard Error of the Mean|1.2|<|0.001||95.0|-6.8|-2.0|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743881|NCT00409773|3207484|Superiority or Other||Mean Difference (Final Values)|-5.4|Standard Error of the Mean|1.2|<|0.001||95.0|-7.8|-2.9|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743882|NCT00409773|3207484|Superiority or Other||Mean Difference (Final Values)|-7.2|Standard Error of the Mean|1.2|<|0.001||95.0|-9.6|-4.8|||ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743883|NCT00409773|3207485|Superiority or Other||Mean Difference (Final Values)|-8.0|Standard Error of the Mean|1.7|<|0.001||95.0|-11.3|-4.6||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743884|NCT00409773|3207485|Superiority or Other||Mean Difference (Final Values)|-10.2|Standard Error of the Mean|1.7|<|0.001||95.0|-13.6|-6.9||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743885|NCT00409773|3207485|Superiority or Other||Mean Difference (Final Values)|-13.1|Standard Error of the Mean|1.7|<|0.001||95.0|-16.5|-9.8||Reported p-value is multiplicity-adjusted. Hochberg procedure was used to adjust for multiple comparisons.|ANOVA|ANOVA with terms for treatment and baseline risk stratum|||
1743886|NCT00409682|3207495|Superiority or Other||Mean Difference (Net)|-1.0|Standard Error of the Mean|2.941||0.735|2-Sided|95.0|-6.88|4.88|||ANCOVA||Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.|Analyzed as change from Baseline to Week 52, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% confidence interval (CI) for the treatment difference were provided. Analysis was conducted in the ITT population for OC.|
1743912|NCT00408993|3207564|Superiority or Other|||||||0.028||||||P-value for Visit 7|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit.|||
1743965|NCT00408876|3207588|Superiority or Other||Mean Difference (Net)|-0.22||||0.542||95.0|-0.95|0.5|||t-test, 2 sided||||
1743887|NCT00409682|3207496|Superiority or Other||Mean Difference (Net)|-4.1|Standard Error of the Mean|2.903||0.161|2-Sided|95.0|-9.86|1.66||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.|ANCOVA||Difference is between adalimumab High-dose and adalimumab Low-dose groups. Baseline means include subjects who had both Baseline and post-Baseline measurements.|"Analyzed as change from Baseline to Week 26, and compared between the two treatment groups. The estimated treatment mean difference, P values, and 95% CI for the treatment difference were provided. Analysis was conducted in the ITT population for OC.~The P value is from the ANCOVA model with treatment as a factor, adjusted for the baseline value, and the strata (response status at Week 4 and prior infliximab experience)."|
1743888|NCT00409682|3207497|Superiority or Other||Mean Difference (Net)|13.51||||0.038|2-Sided|95.0|-0.01|27.04||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.|
1743889|NCT00409682|3207498|Superiority or Other||Mean Difference (Net)|10.72||||0.073|2-Sided|95.0|-3.45|24.89||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical response in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.|
1743890|NCT00409682|3207499|Superiority or Other||Mean Difference (Net)|10.18||||0.1|2-Sided|95.0|-2.62|22.97||The hierarchical stepwise closed testing procedure was implemented to control the overall significance level at 0.05 in the ITT population.|Cochran-Mantel-Haenszel||A significance test for any individual major secondary efficacy endpoint in the hierarchy was to be inferential only if the hypothesis tests of all preceding major secondary efficacy endpoints were statistically significant at 0.050.|The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% CIs for the difference were provided. The analysis was performed for the intent-to-treat (ITT) population using the non-responder imputation (NRI) method.|
1743891|NCT00409682|3207500|Superiority or Other||Mean Difference (Net)|10.29||||0.075|2-Sided|95.0|-3.14|23.71||There is no adjustment for multiple comparison on the primary outcome measure.|Cochran-Mantel-Haenszel||Difference is between adalimumab High-dose and adalimumab Low-dose group.|The point estimates for the number of subjects who achieved PCDAI clinical remission in each treatment group and the difference in number between the groups were provided. The P value and 95% confidence intervals (CIs) for the difference were provided. The P value is from the CMH test adjusted for infliximab use and response status at Week 4. The primary analysis was performed for the intent-to-treat (ITT) using the non-responder (NRI) imputation method.|
1743892|NCT00409409|3207521|Superiority or Other|||||||0.001|||||||ANCOVA||||
1743893|NCT00409292|3207533|Superiority or Other|||||||0.1|||||||binomial hypothesis test||||
1743894|NCT00409188|3207537|Superiority or Other||Hazard Ratio (HR)|0.868||||0.0528|2-Sided|95.0|0.752|1.002|||Regression, Cox||||
1743895|NCT00409188|3207538|Superiority or Other||Hazard Ratio (HR)|0.845||||0.0226|2-Sided|95.0|0.732|0.977|||Regression, Cox||||
1743896|NCT00409188|3207539|Superiority or Other||Hazard Ratio (HR)|0.893||||0.1566|2-Sided|95.0|0.763|1.044|||Regression, Cox||||
1743897|NCT00409006|3207553|Superiority or Other|||||||0.369|||||||Regression, Logistic|Used the Wald Chi-squared statistic from a logistic regression analysis.|||
1743898|NCT00409006|3207554|Superiority or Other|||||||0.0618|||||||Log Rank||||
1743899|NCT00408993|3207555|Superiority or Other|||||||0.017|||||||ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-values.|||
1743900|NCT00408993|3207556|Superiority or Other|||||||0.044||||||P-value for triglycerides|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.|||
1743901|NCT00408993|3207556|Superiority or Other|||||||0.011||||||P-value for Sodium|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.|||
1743902|NCT00408993|3207556|Superiority or Other|||||||0.005||||||P-value for High Density Lipoprotein Cholesterol|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.|||
1743903|NCT00408993|3207556|Superiority or Other|||||||0.014||||||P-value for Chloride|ANOVA|Sums of squares from ANOVA on the ranks: Model=Treatment and Pooled Investigator for treatment effects p-value.|||
1743904|NCT00408993|3207557|Superiority or Other|||||||0.601||||||P-value for Diastolic Blood Pressure|ANOVA|Model=Treatment and Pooled Investigator|||
1743905|NCT00408993|3207557|Superiority or Other|||||||0.642||||||P-value for Systolic Blood Pressure|ANOVA|Model=Treatment and Pooled Investigator|||
1743906|NCT00408993|3207558|Superiority or Other|||||||0.324|||||||ANOVA|Model=Treatment and Pooled Investigator|||
1743907|NCT00408993|3207559|Superiority or Other|||||||0.62|||||||ANOVA|Model=Treatment and Pooled Investigator|||
1743908|NCT00408993|3207560|Superiority or Other|||||||0.59||||||P-value for 8-Item Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.|||
1743909|NCT00408993|3207560|Superiority or Other|||||||0.364||||||P-value for 5-Item Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.|||
1743910|NCT00408993|3207562|Superiority or Other|||||||0.008|||||||Fisher Exact||||
1743911|NCT00408993|3207563|Superiority or Other|||||||0.207|||||||ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.|||
1743913|NCT00408993|3207564|Superiority or Other||||||<|0.001||||||P-value for Visit 6|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit.|||
1743914|NCT00408993|3207564|Superiority or Other||||||<|0.037||||||P-value for Visit 5|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit.|||
1743915|NCT00408993|3207564|Superiority or Other||||||<|0.004||||||P-value for Visit 4|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit.|||
1743916|NCT00408993|3207564|Superiority or Other||||||<|0.955||||||P-value for Visit 3|Mixed Models Analysis|Repeated Measures: Model=Treatment, Pooled Investigator, Visit, Baseline, baseline MDD status, Treatment*Visit and Baseline*Visit.|||
1743917|NCT00408993|3207565|Superiority or Other|||||||0.036|||||||ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.|||
1743918|NCT00408993|3207566|Superiority or Other|||||||0.077||||||P-value for Average Interference Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.|||
1743919|NCT00408993|3207566|Superiority or Other|||||||0.012||||||P-value for Pain Right Now Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.|||
1743920|NCT00408993|3207566|Superiority or Other|||||||0.151||||||P-value for Least Pain Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.|||
1743921|NCT00408993|3207566|Superiority or Other|||||||0.07||||||P-value for Worst Pain Score|ANCOVA|Model=Treatment, Pooled Investigator, Baseline and Major Depressive Disorder status at baseline.|||
1743922|NCT00408993|3207567|Superiority or Other|||||||0.617||||||Treatment effects were evaluated based on a two-sided significance level of 0.05 and interaction effects at 0.10. No adjustments for multiple comparisons were made.|ANCOVA|Model=Treatment, Pooled Investigator and Baseline.||With 104 patients per arm, the study has at least 85% power to detect a treatment group difference of -1.20 points in baseline to endpoint mean change on the BPI 24-hour average pain score between Duloxetine and Placebo. Sample size determined using a two-sided t-test with alpha=0.05, and assuming a common standard deviation of 2.5 and a discontinuation rate of 25%.|
1743923|NCT00408876|3207573|Superiority or Other||Mean Difference (Net)|-0.36||||0.239||95.0|-0.97|0.24|||t-test, 2 sided||||
1743924|NCT00408876|3207573|Superiority or Other||Mean Difference (Net)|-0.12||||0.734||95.0|-0.85|0.6|||t-test, 2 sided||||
1743925|NCT00408876|3207573|Superiority or Other||Mean Difference (Net)|0.24||||0.518||95.0|-0.48|0.96|||t-test, 2 sided||||
1743926|NCT00408876|3207573|Superiority or Other||Mean Difference (Net)|-0.82||||0.007||95.0|-1.42|-0.22|||t-test, 2 sided||||
1743927|NCT00408876|3207573|Superiority or Other||Mean Difference (Net)|-0.46||||0.128||95.0|-1.05|0.13|||t-test, 2 sided||||
1743928|NCT00408876|3207573|Superiority or Other||Mean Difference (Net)|-0.7||||0.057||95.0|-1.41|0.02|||t-test, 2 sided||||
1743929|NCT00408876|3207574|Superiority or Other||Mean Difference (Net)|3.73||||0.001||95.0|1.44|6.02|||t-test, 2 sided||||
1743930|NCT00408876|3207574|Superiority or Other||Mean Difference (Net)|3.45||||0.014||95.0|0.71|6.19|||t-test, 2 sided||||
1743931|NCT00408876|3207574|Superiority or Other||Mean Difference (Net)|-0.28||||0.841||95.0|-3.02|2.46|||t-test, 2 sided||||
1743932|NCT00408876|3207574|Superiority or Other||Mean Difference (Net)|3.62||||0.002||95.0|1.35|5.9|||t-test, 2 sided||||
1743933|NCT00408876|3207574|Superiority or Other||Mean Difference (Net)|-0.11||||0.926||95.0|-2.35|2.14|||t-test, 2 sided||||
1743934|NCT00408876|3207574|Superiority or Other||Mean Difference (Net)|0.17||||0.901||95.0|-2.54|2.89|||t-test, 2 sided||||
1743935|NCT00408876|3207575|Superiority or Other||Mean Difference (Net)|2.17||||0.207||95.0|-1.21|5.55|||t-test, 2 sided||||
1743936|NCT00408876|3207575|Superiority or Other||Mean Difference (Net)|1.64||||0.426||95.0|-2.4|5.67|||t-test, 2 sided||||
1743937|NCT00408876|3207575|Superiority or Other||Mean Difference (Net)|-0.54||||0.794||95.0|-4.58|3.5|||t-test, 2 sided||||
1743938|NCT00408876|3207575|Superiority or Other||Mean Difference (Net)|2.03||||0.234||95.0|-1.32|5.39|||t-test, 2 sided||||
1743939|NCT00408876|3207575|Superiority or Other||Mean Difference (Net)|-0.14||||0.934||95.0|-3.45|3.17|||t-test, 2 sided||||
1743940|NCT00408876|3207575|Superiority or Other||Mean Difference (Net)|0.4||||0.846||95.0|-3.61|4.4|||t-test, 2 sided||||
1743941|NCT00408876|3207576|Superiority or Other||Mean Difference (Net)|-0.89||||0.473||95.0|-3.33|1.55|||t-test, 2 sided||||
1743942|NCT00408876|3207576|Superiority or Other||Mean Difference (Net)|3.0||||0.044||95.0|0.08|5.91|||t-test, 2 sided||||
1743943|NCT00408876|3207576|Superiority or Other||Mean Difference (Net)|3.89||||0.009||95.0|0.97|6.8|||t-test, 2 sided||||
1743944|NCT00408876|3207576|Superiority or Other||Mean Difference (Net)|1.61||||0.191||95.0|-0.81|4.03|||t-test, 2 sided||||
1743945|NCT00408876|3207576|Superiority or Other||Mean Difference (Net)|2.5||||0.04||95.0|0.11|4.89|||t-test, 2 sided||||
1743946|NCT00408876|3207576|Superiority or Other||Mean Difference (Net)|-1.38||||0.348||95.0|-4.28|1.51|||t-test, 2 sided||||
1743947|NCT00408876|3207577|Superiority or Other|||||||0.001|||||||t-test, 2 sided||||
1743948|NCT00408876|3207577|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1743949|NCT00408876|3207577|Superiority or Other||||||<|0.005|||||||t-test, 2 sided||||
1743950|NCT00408876|3207578|Superiority or Other|||||||0.03|||||||t-test, 2 sided||||
1743951|NCT00408876|3207579|Superiority or Other|||||||0.031|||||||t-test, 2 sided||||
1743952|NCT00408876|3207580|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1743953|NCT00408876|3207581|Superiority or Other|||||||0.042|||||||t-test, 2 sided||||
1743954|NCT00408876|3207582|Superiority or Other|||||||0.039|||||||t-test, 2 sided||||
1743955|NCT00408876|3207583|Superiority or Other|||||||0.046|||||||t-test, 2 sided||||
1743956|NCT00408876|3207583|Superiority or Other|||||||0.015|||||||t-test, 2 sided||||
1743957|NCT00408876|3207584|Superiority or Other|||||||0.048|||||||t-test, 2 sided||||
1743966|NCT00408876|3207588|Superiority or Other||Mean Difference (Net)|-0.13||||0.723||95.0|-0.84|0.59|||t-test, 2 sided||||
1743967|NCT00408876|3207588|Superiority or Other||Mean Difference (Net)|0.39||||0.378||95.0|-0.48|1.25|||t-test, 2 sided||||
1743968|NCT00408876|3207589|Superiority or Other||Mean Difference (Net)|1.91||||0.006||95.0|0.54|3.27|||t-test, 2 sided||||
1743969|NCT00408876|3207589|Superiority or Other||Mean Difference (Net)|1.61||||0.053||95.0|-0.02|3.24|||t-test, 2 sided||||
1743970|NCT00408876|3207589|Superiority or Other||Mean Difference (Net)|-0.3||||0.721||95.0|-1.92|1.33|||t-test, 2 sided||||
1743971|NCT00408876|3207589|Superiority or Other||Mean Difference (Net)|1.39||||0.043||95.0|0.04|2.74|||t-test, 2 sided||||
1743972|NCT00408876|3207589|Superiority or Other||Mean Difference (Net)|-0.52||||0.445||95.0|-1.85|0.81|||t-test, 2 sided||||
1743973|NCT00408876|3207589|Superiority or Other||Mean Difference (Net)|-0.22||||0.786||95.0|-1.83|1.39|||t-test, 2 sided||||
1743974|NCT00408876|3207590|Superiority or Other||Mean Difference (Net)|0.01||||0.614||95.0|-0.03|0.05|||t-test, 2 sided||||
1743975|NCT00408876|3207590|Superiority or Other||Mean Difference (Net)|0.04||||0.1||95.0|-0.01|0.09|||t-test, 2 sided||||
1743976|NCT00408876|3207590|Superiority or Other||Mean Difference (Net)|0.03||||0.218||95.0|-0.02|0.08|||t-test, 2 sided||||
1743977|NCT00408876|3207590|Superiority or Other||Mean Difference (Net)|0.03||||0.143||95.0|-0.01|0.07|||t-test, 2 sided||||
1743978|NCT00408876|3207590|Superiority or Other||Mean Difference (Net)|0.02||||0.33||95.0|-0.02|0.06|||t-test, 2 sided||||
1743979|NCT00408876|3207590|Superiority or Other||Mean Difference (Net)|-0.01||||0.663||95.0|-0.06|0.04|||t-test, 2 sided||||
1743980|NCT00408876|3207591|Superiority or Other||Mean Difference (Net)|-0.98||||0.05||95.0|-1.97|0.0|||t-test, 2 sided||||
1743981|NCT00408876|3207591|Superiority or Other||Mean Difference (Net)|-0.24||||0.686||95.0|-1.43|0.94|||t-test, 2 sided||||
1743982|NCT00408876|3207591|Superiority or Other||Mean Difference (Net)|0.74||||0.219||95.0|-0.44|1.93|||t-test, 2 sided||||
1743983|NCT00408876|3207591|Superiority or Other||Mean Difference (Net)|-0.46||||0.351||95.0|-1.44|0.51|||t-test, 2 sided||||
1743984|NCT00408876|3207591|Superiority or Other||Mean Difference (Net)|0.52||||0.288||95.0|-0.44|1.49|||t-test, 2 sided||||
1743985|NCT00408876|3207591|Superiority or Other||Mean Difference (Net)|-0.22||||0.713||95.0|-1.39|0.95|||t-test, 2 sided||||
1743986|NCT00408876|3207592|Superiority or Other||Mean Difference (Net)|-0.08||||0.711||95.0|-0.5|0.34|||t-test, 2 sided||||
1743987|NCT00408876|3207592|Superiority or Other||Mean Difference (Net)|-0.36||||0.161||95.0|-0.88|0.15|||t-test, 2 sided||||
1743988|NCT00408876|3207592|Superiority or Other||Mean Difference (Net)|-0.29||||0.272||95.0|-0.79|0.22|||t-test, 2 sided||||
1743989|NCT00408876|3207592|Superiority or Other||Mean Difference (Net)|-0.12||||0.573||95.0|-0.54|0.3|||t-test, 2 sided||||
1743990|NCT00408876|3207592|Superiority or Other||Mean Difference (Net)|-0.04||||0.848||95.0|-0.45|0.37|||t-test, 2 sided||||
1743991|NCT00408876|3207592|Superiority or Other||Mean Difference (Net)|0.24||||0.34||95.0|-0.26|0.75|||t-test, 2 sided||||
1743992|NCT00408876|3207593|Superiority or Other||Mean Difference (Net)|0.05||||0.805||95.0|-0.36|0.46|||t-test, 2 sided||||
1743993|NCT00408876|3207593|Superiority or Other||Mean Difference (Net)|0.05||||0.857||95.0|-0.45|0.54|||t-test, 2 sided||||
1743994|NCT00408876|3207593|Superiority or Other||Mean Difference (Net)|-0.01||||0.981||95.0|-0.5|0.49|||t-test, 2 sided||||
1743995|NCT00408876|3207593|Superiority or Other||Mean Difference (Net)|0.05||||0.793||95.0|-0.35|0.46|||t-test, 2 sided||||
1743996|NCT00408876|3207593|Superiority or Other||Mean Difference (Net)|0.0||||0.99||95.0|-0.4|0.4|||t-test, 2 sided||||
1743997|NCT00408876|3207593|Superiority or Other||Mean Difference (Net)|0.01||||0.972||95.0|-0.48|0.5|||t-test, 2 sided||||
1743998|NCT00408876|3207594|Superiority or Other||Mean Difference (Net)|-0.05||||0.687||95.0|-0.3|0.2|||t-test, 2 sided||||
1743999|NCT00408876|3207594|Superiority or Other||Mean Difference (Net)|0.03||||0.819||95.0|-0.26|0.33|||t-test, 2 sided||||
1744000|NCT00408876|3207594|Superiority or Other||Mean Difference (Net)|0.09||||0.573||95.0|-0.21|0.38|||t-test, 2 sided||||
1744001|NCT00408876|3207594|Superiority or Other||Mean Difference (Net)|0.06||||0.628||95.0|-0.18|0.31|||t-test, 2 sided||||
1744002|NCT00408876|3207594|Superiority or Other||Mean Difference (Net)|0.11||||0.368||95.0|-0.13|0.35|||t-test, 2 sided||||
1744003|NCT00408876|3207594|Superiority or Other||Mean Difference (Net)|0.03||||0.862||95.0|-0.27|0.32|||t-test, 2 sided||||
1744004|NCT00408876|3207595|Superiority or Other||Mean Difference (Net)|0.56||||0.289||95.0|-0.48|1.59|||t-test, 2 sided||||
1744005|NCT00408876|3207595|Superiority or Other||Mean Difference (Net)|1.31||||0.04||95.0|0.06|2.56|||t-test, 2 sided||||
1744006|NCT00408876|3207595|Superiority or Other||Mean Difference (Net)|0.75||||0.234||95.0|-0.49|2.0|||t-test, 2 sided||||
1744007|NCT00408876|3207595|Superiority or Other||Mean Difference (Net)|0.89||||0.089||95.0|-0.14|1.91|||t-test, 2 sided||||
1744008|NCT00408876|3207595|Superiority or Other||Mean Difference (Net)|0.33||||0.524||95.0|-0.69|1.35|||t-test, 2 sided||||
1744009|NCT00408876|3207595|Superiority or Other||Mean Difference (Net)|-0.42||||0.501||95.0|-1.66|0.81|||t-test, 2 sided||||
1744010|NCT00408876|3207596|Superiority or Other||Mean Difference (Net)|-0.53||||0.288||95.0|-1.5|0.45|||t-test, 2 sided||||
1744011|NCT00408876|3207596|Superiority or Other||Mean Difference (Net)|0.25||||0.675||95.0|-0.92|1.42|||t-test, 2 sided||||
1744012|NCT00408876|3207596|Superiority or Other||Mean Difference (Net)|0.78||||0.193||95.0|-0.39|1.94|||t-test, 2 sided||||
1744013|NCT00408876|3207596|Superiority or Other||Mean Difference (Net)|0.07||||0.88||95.0|-0.89|1.04|||t-test, 2 sided||||
1744014|NCT00408876|3207596|Superiority or Other||Mean Difference (Net)|0.6||||0.217||95.0|-0.35|1.55|||t-test, 2 sided||||
1744015|NCT00408876|3207596|Superiority or Other||Mean Difference (Net)|-0.18||||0.766||95.0|-1.33|0.98|||t-test, 2 sided||||
1744016|NCT00408876|3207597|Superiority or Other||Mean Difference (Net)|-0.42||||0.299||95.0|-1.22|0.38|||t-test, 2 sided||||
1744017|NCT00408876|3207597|Superiority or Other||Mean Difference (Net)|0.11||||0.822||95.0|-0.86|1.09|||t-test, 2 sided||||
1744018|NCT00408876|3207597|Superiority or Other||Mean Difference (Net)|0.54||||0.279||95.0|-0.44|1.51|||t-test, 2 sided||||
1744019|NCT00408876|3207597|Superiority or Other||Mean Difference (Net)|0.16||||0.7||95.0|-0.64|0.95|||t-test, 2 sided||||
1744020|NCT00408876|3207597|Superiority or Other||Mean Difference (Net)|0.58||||0.147||95.0|-0.21|1.36|||t-test, 2 sided||||
1744021|NCT00408876|3207597|Superiority or Other||Mean Difference (Net)|0.04||||0.929||95.0|-0.92|1.0|||t-test, 2 sided||||
1744022|NCT00408876|3207598|Superiority or Other||Mean Difference (Net)|0.16||||0.564||95.0|-0.38|0.7|||t-test, 2 sided||||
1744023|NCT00408876|3207598|Superiority or Other||Mean Difference (Net)|0.6||||0.069||95.0|-0.05|1.25|||t-test, 2 sided||||
1744024|NCT00408876|3207598|Superiority or Other||Mean Difference (Net)|0.44||||0.18||95.0|-0.21|1.1|||t-test, 2 sided||||
1744025|NCT00408876|3207598|Superiority or Other||Mean Difference (Net)|0.75||||0.006||95.0|0.22|1.29|||t-test, 2 sided||||
1744026|NCT00408876|3207598|Superiority or Other||Mean Difference (Net)|0.6||||0.027||95.0|0.07|1.12|||t-test, 2 sided||||
1744027|NCT00408876|3207598|Superiority or Other||Mean Difference (Net)|0.15||||0.645||95.0|-0.49|0.79|||t-test, 2 sided||||
1744028|NCT00408876|3207599|Superiority or Other||Mean Difference (Net)|0.84||||0.491||95.0|-1.55|3.23|||t-test, 2 sided||||
1744029|NCT00408876|3207599|Superiority or Other||Mean Difference (Net)|1.78||||0.23||95.0|-1.13|4.69|||t-test, 2 sided||||
1744030|NCT00408876|3207599|Superiority or Other||Mean Difference (Net)|0.94||||0.524||95.0|-1.96|3.83|||t-test, 2 sided||||
1744031|NCT00408876|3207599|Superiority or Other||Mean Difference (Net)|1.74||||0.15||95.0|-0.63|4.11|||t-test, 2 sided||||
1744032|NCT00408876|3207599|Superiority or Other||Mean Difference (Net)|0.9||||0.451||95.0|-1.44|3.24|||t-test, 2 sided||||
1744033|NCT00408876|3207599|Superiority or Other||Mean Difference (Net)|-0.04||||0.977||95.0|-2.91|2.83|||t-test, 2 sided||||
1744034|NCT00408876|3207600|Superiority or Other||Mean Difference (Net)|-1.84||||0.102||95.0|-4.04|0.37|||t-test, 2 sided||||
1744035|NCT00408876|3207600|Superiority or Other||Mean Difference (Net)|-1.27||||0.345||95.0|-3.92|1.38|||t-test, 2 sided||||
1744036|NCT00408876|3207600|Superiority or Other||Mean Difference (Net)|0.56||||0.677||95.0|-2.09|3.21|||t-test, 2 sided||||
1744037|NCT00408876|3207600|Superiority or Other||Mean Difference (Net)|-0.81||||0.465||95.0|-3.0|1.37|||t-test, 2 sided||||
1744038|NCT00408876|3207600|Superiority or Other||Mean Difference (Net)|1.02||||0.352||95.0|-1.14|3.18|||t-test, 2 sided||||
1744039|NCT00408876|3207600|Superiority or Other||Mean Difference (Net)|0.46||||0.729||95.0|-2.16|3.08|||t-test, 2 sided||||
1744040|NCT00408876|3207601|Superiority or Other||Mean Difference (Net)|1.37||||0.012||95.0|0.3|2.44|||t-test, 2 sided||||
1744041|NCT00408876|3207601|Superiority or Other||Mean Difference (Net)|0.51||||0.438||95.0|-0.77|1.79|||t-test, 2 sided||||
1744042|NCT00408876|3207601|Superiority or Other||Mean Difference (Net)|-0.86||||0.185||95.0|-2.14|0.41|||t-test, 2 sided||||
1744043|NCT00408876|3207601|Superiority or Other||Mean Difference (Net)|0.3||||0.58||95.0|-0.76|1.36|||t-test, 2 sided||||
1744044|NCT00408876|3207601|Superiority or Other||Mean Difference (Net)|-1.07||||0.045||95.0|-2.12|-0.02|||t-test, 2 sided||||
1744045|NCT00408876|3207601|Superiority or Other||Mean Difference (Net)|-0.21||||0.747||95.0|-1.47|1.06|||t-test, 2 sided||||
1744046|NCT00408876|3207602|Superiority or Other|||||||0.779|||||||Fisher Exact||||
1744047|NCT00408876|3207602|Superiority or Other|||||||0.053|||||||Fisher Exact||||
1744048|NCT00408876|3207602|Superiority or Other|||||||0.107|||||||Fisher Exact||||
1744049|NCT00408876|3207602|Superiority or Other|||||||0.255|||||||Fisher Exact||||
1744050|NCT00408876|3207602|Superiority or Other|||||||0.472|||||||Fisher Exact||||
1744051|NCT00408876|3207602|Superiority or Other|||||||0.356|||||||Fisher Exact||||
1744052|NCT00408876|3207603|Superiority or Other|||||||0.587|||||||Fisher Exact||||
1744053|NCT00408876|3207603|Superiority or Other|||||||0.049|||||||Fisher Exact||||
1744054|NCT00408876|3207603|Superiority or Other|||||||0.142|||||||Fisher Exact||||
1744055|NCT00408876|3207603|Superiority or Other|||||||0.033|||||||Fisher Exact||||
1744056|NCT00408876|3207603|Superiority or Other|||||||0.141|||||||Fisher Exact||||
1744057|NCT00408876|3207603|Superiority or Other|||||||0.869|||||||Fisher Exact||||
1744058|NCT00408876|3207604|Superiority or Other||Mean Difference (Net)|0.48||||0.066||95.0|-0.03|1.0|||t-test, 2 sided||||
1744059|NCT00408876|3207604|Superiority or Other||Mean Difference (Net)|-0.08||||0.798||95.0|-0.71|0.54|||t-test, 2 sided||||
1744060|NCT00408876|3207604|Superiority or Other||Mean Difference (Net)|-0.56||||0.075||95.0|-1.19|0.06|||t-test, 2 sided||||
1744061|NCT00408876|3207604|Superiority or Other||Mean Difference (Net)|-0.31||||0.233||95.0|-0.82|0.2|||t-test, 2 sided||||
1744062|NCT00408876|3207604|Superiority or Other||Mean Difference (Net)|-0.79||||0.002||95.0|-1.3|-0.29|||t-test, 2 sided||||
1744063|NCT00408876|3207604|Superiority or Other||Mean Difference (Net)|-0.23||||0.465||95.0|-0.84|0.39|||t-test, 2 sided||||
1744064|NCT00408876|3207605|Superiority or Other|||||||0.756|||||||Repeated Measures||||
1744065|NCT00408876|3207605|Superiority or Other|||||||0.036|||||||Repeated Measures||||
1744066|NCT00408876|3207605|Superiority or Other|||||||0.014|||||||Repeated Measures||||
1744067|NCT00408876|3207605|Superiority or Other|||||||0.236|||||||Repeated Measures||||
1744068|NCT00408876|3207605|Superiority or Other|||||||0.11|||||||Repeated Measures||||
1744069|NCT00408876|3207605|Superiority or Other|||||||0.243|||||||Repeated Measures||||
1744070|NCT00408876|3207606|Superiority or Other|||||||0.647|||||||Repeated Measures||||
1744071|NCT00408876|3207606|Superiority or Other|||||||0.06|||||||Repeated Measures||||
1744072|NCT00408876|3207606|Superiority or Other|||||||0.117|||||||Repeated Measures||||
1744073|NCT00408876|3207606|Superiority or Other|||||||0.035|||||||Repeated Measures||||
1744074|NCT00408876|3207606|Superiority or Other|||||||0.079|||||||Repeated Measures||||
1744080|NCT00408876|3207607|Superiority or Other||||||<|0.022|||||||Repeated Measures||||
1744081|NCT00408876|3207607|Superiority or Other||||||<|0.733|||||||Repeated Measures||||
1744082|NCT00408876|3207608|Superiority or Other|||||||0.171|||||||Repeated Measures||||
1744083|NCT00408876|3207608|Superiority or Other|||||||0.006|||||||Repeated Measures||||
1744084|NCT00408876|3207608|Superiority or Other|||||||0.09|||||||Repeated Measures||||
1744085|NCT00408876|3207608|Superiority or Other||||||<|0.001|||||||Repeated Measures||||
1744086|NCT00408876|3207608|Superiority or Other||||||<|0.026|||||||Repeated Measures||||
1744087|NCT00408876|3207608|Superiority or Other||||||<|0.91|||||||Repeated Measures||||
1744088|NCT00408876|3207609|Superiority or Other|||||||0.313|||||||Repeated Measures||||
1744089|NCT00408876|3207609|Superiority or Other|||||||0.003|||||||Repeated Measures||||
1744090|NCT00408876|3207609|Superiority or Other|||||||0.026|||||||Repeated Measures||||
1744091|NCT00408876|3207609|Superiority or Other|||||||0.002|||||||Repeated Measures||||
1744092|NCT00408876|3207609|Superiority or Other|||||||0.031|||||||Repeated Measures||||
1744093|NCT00408876|3207609|Superiority or Other|||||||0.634|||||||Repeated Measures||||
1744094|NCT00408876|3207610|Superiority or Other|||||||0.416|||||||Repeated Measures||||
1744095|NCT00408876|3207610|Superiority or Other|||||||0.007|||||||Repeated Measures||||
1744096|NCT00408876|3207610|Superiority or Other|||||||0.036|||||||Repeated Measures||||
1744097|NCT00408876|3207610|Superiority or Other||||||<|0.001|||||||Repeated Measures||||
1744098|NCT00408876|3207610|Superiority or Other||||||<|0.007|||||||Repeated Measures||||
1744099|NCT00408876|3207610|Superiority or Other||||||<|0.931|||||||Repeated Measures||||
1744100|NCT00408876|3207611|Superiority or Other|||||||0.435|||||||Repeated Measures||||
1744101|NCT00408876|3207611|Superiority or Other|||||||0.023|||||||Repeated Measures||||
1744102|NCT00408876|3207611|Superiority or Other|||||||0.097|||||||Repeated Measures||||
1744103|NCT00408876|3207611|Superiority or Other|||||||0.001|||||||Repeated Measures||||
1744104|NCT00408876|3207611|Superiority or Other|||||||0.012|||||||Repeated Measures||||
1744105|NCT00408876|3207611|Superiority or Other|||||||0.709|||||||Repeated Measures||||
1744106|NCT00408876|3207612|Superiority or Other|||||||0.48|||||||Repeated Measures||||
1744107|NCT00408876|3207612|Superiority or Other|||||||0.033|||||||Repeated Measures||||
1744108|NCT00408876|3207612|Superiority or Other|||||||0.116|||||||Repeated Measures||||
1744109|NCT00408876|3207612|Superiority or Other||||||<|0.001|||||||Repeated Measures||||
1744110|NCT00408876|3207612|Superiority or Other||||||<|0.001|||||||Repeated Measures||||
1744111|NCT00408876|3207612|Superiority or Other||||||<|0.309|||||||Repeated Measures||||
1744112|NCT00408876|3207613|Superiority or Other|||||||0.219|||||||Repeated Measures||||
1744113|NCT00408876|3207613|Superiority or Other|||||||0.01|||||||Repeated Measures||||
1744114|NCT00408876|3207613|Superiority or Other|||||||0.112|||||||Repeated Measures||||
1744115|NCT00408876|3207613|Superiority or Other||||||<|0.001|||||||Repeated Measures||||
1744116|NCT00408876|3207613|Superiority or Other||||||<|0.006|||||||Repeated Measures||||
1744117|NCT00408876|3207613|Superiority or Other||||||<|0.516|||||||Repeated Measures||||
1744118|NCT00408876|3207614|Superiority or Other|||||||0.072|||||||Repeated Measures||||
1744119|NCT00408876|3207614|Superiority or Other|||||||0.002|||||||Repeated Measures||||
1744120|NCT00408876|3207614|Superiority or Other|||||||0.115|||||||Repeated Measures||||
1744121|NCT00408876|3207614|Superiority or Other||||||<|0.001|||||||Repeated Measures||||
1744122|NCT00408876|3207614|Superiority or Other||||||<|0.009|||||||Repeated Measures||||
1744123|NCT00408876|3207614|Superiority or Other||||||<|0.575|||||||Repeated Measures||||
1744124|NCT00408876|3207615|Superiority or Other|||||||0.635|||||||Repeated Measures||||
1744125|NCT00408876|3207615|Superiority or Other|||||||0.04|||||||Repeated Measures||||
1744126|NCT00408876|3207615|Superiority or Other|||||||0.095|||||||Repeated Measures||||
1744127|NCT00408876|3207615|Superiority or Other|||||||0.007|||||||Repeated Measures||||
1744128|NCT00408876|3207615|Superiority or Other|||||||0.026|||||||Repeated Measures||||
1744129|NCT00408876|3207615|Superiority or Other|||||||0.885|||||||Repeated Measures||||
1744130|NCT00408876|3207616|Superiority or Other|||||||0.212|||||||Repeated Measures||||
1744131|NCT00408876|3207616|Superiority or Other|||||||0.208|||||||Repeated Measures||||
1744132|NCT00408876|3207616|Superiority or Other|||||||0.816|||||||Repeated Measures||||
1744133|NCT00408876|3207616|Superiority or Other|||||||0.056|||||||Repeated Measures||||
1744134|NCT00408876|3207616|Superiority or Other|||||||0.507|||||||Repeated Measures||||
1744135|NCT00408876|3207616|Superiority or Other|||||||0.756|||||||Repeated Measures||||
1744136|NCT00408876|3207617|Superiority or Other||Mean Difference (Net)|0.64||||0.052||95.0|0.0|1.28|||t-test, 2 sided||||
1744137|NCT00408876|3207617|Superiority or Other||Mean Difference (Net)|-0.02||||0.96||95.0|-0.79|0.75|||t-test, 2 sided||||
1744138|NCT00408876|3207617|Superiority or Other||Mean Difference (Net)|-0.66||||0.097||95.0|-1.43|0.12|||t-test, 2 sided||||
1744139|NCT00408876|3207617|Superiority or Other||Mean Difference (Net)|-0.09||||0.773||95.0|-0.73|0.54|||t-test, 2 sided||||
1744140|NCT00408876|3207617|Superiority or Other||Mean Difference (Net)|-0.73||||0.024||95.0|-1.36|-0.1|||t-test, 2 sided||||
1744141|NCT00408876|3207617|Superiority or Other||Mean Difference (Net)|-0.07||||0.849||95.0|-0.84|0.69|||t-test, 2 sided||||
1744142|NCT00408876|3207618|Superiority or Other||Mean Difference (Net)|0.37||||0.262||95.0|-0.27|1.01|||t-test, 2 sided||||
1745099|NCT00405392|3208174|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1744143|NCT00408876|3207618|Superiority or Other||Mean Difference (Net)|-0.52||||0.184||95.0|-1.3|0.25|||t-test, 2 sided||||
1744144|NCT00408876|3207618|Superiority or Other||Mean Difference (Net)|-0.89||||0.024||95.0|-1.67|-0.12|||t-test, 2 sided||||
1744145|NCT00408876|3207618|Superiority or Other||Mean Difference (Net)|-0.49||||0.132||95.0|-1.12|0.15|||t-test, 2 sided||||
1744146|NCT00408876|3207618|Superiority or Other||Mean Difference (Net)|-0.85||||0.008||95.0|-1.49|-0.22|||t-test, 2 sided||||
1744147|NCT00408876|3207618|Superiority or Other||Mean Difference (Net)|0.04||||0.925||95.0|-0.73|0.8|||t-test, 2 sided||||
1744148|NCT00408876|3207619|Superiority or Other||Mean Difference (Net)|0.59||||0.033||95.0|0.05|1.13|||t-test, 2 sided||||
1744149|NCT00408876|3207619|Superiority or Other||Mean Difference (Net)|0.05||||0.876||95.0|-0.6|0.7|||t-test, 2 sided||||
1744150|NCT00408876|3207619|Superiority or Other||Mean Difference (Net)|-0.54||||0.105||95.0|-1.19|0.11|||t-test, 2 sided||||
1744151|NCT00408876|3207619|Superiority or Other||Mean Difference (Net)|-0.34||||0.213||95.0|-0.87|0.2|||t-test, 2 sided||||
1744152|NCT00408876|3207619|Superiority or Other||Mean Difference (Net)|-0.93|||<|0.001||95.0|-1.46|-0.4|||t-test, 2 sided||||
1744153|NCT00408876|3207619|Superiority or Other||Mean Difference (Net)|-0.39|||<|0.234||95.0|-1.03|0.25|||t-test, 2 sided||||
1744154|NCT00408876|3207620|Superiority or Other||Mean Difference (Net)|0.29||||0.422||95.0|-0.42|1.0|||t-test, 2 sided||||
1744155|NCT00408876|3207620|Superiority or Other||Mean Difference (Net)|-0.18||||0.673||95.0|-1.04|0.68|||t-test, 2 sided||||
1744156|NCT00408876|3207620|Superiority or Other||Mean Difference (Net)|-0.47||||0.278||95.0|-1.33|0.38|||t-test, 2 sided||||
1744157|NCT00408876|3207620|Superiority or Other||Mean Difference (Net)|-0.44||||0.22||95.0|-1.14|0.26|||t-test, 2 sided||||
1744158|NCT00408876|3207620|Superiority or Other||Mean Difference (Net)|-0.73||||0.041||95.0|-1.42|-0.03|||t-test, 2 sided||||
1744159|NCT00408876|3207620|Superiority or Other||Mean Difference (Net)|-0.25||||0.556||95.0|-1.1|0.59|||t-test, 2 sided||||
1744160|NCT00408876|3207621|Superiority or Other||Mean Difference (Net)|0.44||||0.191||95.0|-0.22|1.11|||t-test, 2 sided||||
1744161|NCT00408876|3207621|Superiority or Other||Mean Difference (Net)|-0.1||||0.802||95.0|-0.91|0.7|||t-test, 2 sided||||
1744162|NCT00408876|3207621|Superiority or Other||Mean Difference (Net)|-0.54||||0.182||95.0|-1.35|0.26|||t-test, 2 sided||||
1744163|NCT00408876|3207621|Superiority or Other||Mean Difference (Net)|-0.46||||0.169||95.0|-1.12|0.2|||t-test, 2 sided||||
1744164|NCT00408876|3207621|Superiority or Other||Mean Difference (Net)|-0.9||||0.007||95.0|-1.55|-0.25|||t-test, 2 sided||||
1744165|NCT00408876|3207621|Superiority or Other||Mean Difference (Net)|-0.36||||0.374||95.0|-1.15|0.43|||t-test, 2 sided||||
1744166|NCT00408876|3207622|Superiority or Other||Mean Difference (Net)|0.56||||0.064||95.0|-0.03|1.15|||t-test, 2 sided||||
1744167|NCT00408876|3207622|Superiority or Other||Mean Difference (Net)|-0.2||||0.573||95.0|-0.92|0.51|||t-test, 2 sided||||
1744168|NCT00408876|3207622|Superiority or Other||Mean Difference (Net)|-0.76||||0.036||95.0|-1.48|-0.05|||t-test, 2 sided||||
1744169|NCT00408876|3207622|Superiority or Other||Mean Difference (Net)|-0.26||||0.392||95.0|-0.84|0.33|||t-test, 2 sided||||
1744170|NCT00408876|3207622|Superiority or Other||Mean Difference (Net)|-0.81||||0.006||95.0|-1.4|-0.23|||t-test, 2 sided||||
1744171|NCT00408876|3207622|Superiority or Other||Mean Difference (Net)|-0.05||||0.887||95.0|-0.76|0.65|||t-test, 2 sided||||
1744172|NCT00408876|3207623|Superiority or Other||Mean Difference (Net)|0.16||||0.637||95.0|-0.5|0.82|||t-test, 2 sided||||
1744173|NCT00408876|3207623|Superiority or Other||Mean Difference (Net)|-0.37||||0.367||95.0|-1.17|0.43|||t-test, 2 sided||||
1744174|NCT00408876|3207623|Superiority or Other||Mean Difference (Net)|-0.53||||0.196||95.0|-1.32|0.27|||t-test, 2 sided||||
1744175|NCT00408876|3207623|Superiority or Other||Mean Difference (Net)|-0.39||||0.239||95.0|-1.05|0.26|||t-test, 2 sided||||
1744176|NCT00408876|3207623|Superiority or Other||Mean Difference (Net)|-0.55||||0.096||95.0|-1.2|0.1|||t-test, 2 sided||||
1744177|NCT00408876|3207623|Superiority or Other||Mean Difference (Net)|-0.03||||0.948||95.0|-0.81|0.76|||t-test, 2 sided||||
1744178|NCT00408876|3207624|Superiority or Other||Mean Difference (Net)|0.06||||0.857||95.0|-0.6|0.72|||t-test, 2 sided||||
1744179|NCT00408876|3207624|Superiority or Other||Mean Difference (Net)|-0.97||||0.016||95.0|-1.77|-0.18|||t-test, 2 sided||||
1744180|NCT00408876|3207624|Superiority or Other||Mean Difference (Net)|-1.03||||0.011||95.0|-1.83|-0.24|||t-test, 2 sided||||
1744181|NCT00408876|3207624|Superiority or Other||Mean Difference (Net)|-0.87||||0.009||95.0|-1.52|-0.22|||t-test, 2 sided||||
1744182|NCT00408876|3207624|Superiority or Other||Mean Difference (Net)|-0.93||||0.005||95.0|-1.57|-0.28|||t-test, 2 sided||||
1744183|NCT00408876|3207624|Superiority or Other||Mean Difference (Net)|0.11||||0.79||95.0|-0.68|0.89|||t-test, 2 sided||||
1744184|NCT00408876|3207625|Superiority or Other||Mean Difference (Net)|0.05||||0.872||95.0|-0.54|0.64|||t-test, 2 sided||||
1744185|NCT00408876|3207625|Superiority or Other||Mean Difference (Net)|-0.67||||0.07||95.0|-1.39|0.05|||t-test, 2 sided||||
1744186|NCT00408876|3207625|Superiority or Other||Mean Difference (Net)|-0.71||||0.051||95.0|-1.43|0.0|||t-test, 2 sided||||
1744187|NCT00408876|3207625|Superiority or Other||Mean Difference (Net)|-0.58||||0.054||95.0|-1.17|0.01|||t-test, 2 sided||||
1744188|NCT00408876|3207625|Superiority or Other||Mean Difference (Net)|-0.63||||0.035||95.0|-1.21|-0.04|||t-test, 2 sided||||
1744189|NCT00408876|3207625|Superiority or Other||Mean Difference (Net)|0.09||||0.813||95.0|-0.63|0.8|||t-test, 2 sided||||
1744190|NCT00408876|3207626|Superiority or Other||Mean Difference (Net)|-0.1||||0.727||95.0|-0.66|0.46|||t-test, 2 sided||||
1744191|NCT00408876|3207626|Superiority or Other||Mean Difference (Net)|-0.85||||0.014||95.0|-1.54|-0.17|||t-test, 2 sided||||
1744192|NCT00408876|3207626|Superiority or Other||Mean Difference (Net)|-0.75||||0.03||95.0|-1.43|-0.07|||t-test, 2 sided||||
1744193|NCT00408876|3207626|Superiority or Other||Mean Difference (Net)|-0.65||||0.024||95.0|-1.21|-0.09|||t-test, 2 sided||||
1744194|NCT00408876|3207626|Superiority or Other||Mean Difference (Net)|-0.55||||0.053||95.0|-1.1|0.01|||t-test, 2 sided||||
1744195|NCT00408876|3207626|Superiority or Other||Mean Difference (Net)|0.21||||0.543||95.0|-0.46|0.88|||t-test, 2 sided||||
1744196|NCT00408876|3207627|Superiority or Other||Mean Difference (Net)|-0.01||||0.988||95.0|-0.7|0.69|||t-test, 2 sided||||
1744197|NCT00408876|3207627|Superiority or Other||Mean Difference (Net)|-0.99||||0.02||95.0|-1.83|-0.16|||t-test, 2 sided||||
1744198|NCT00408876|3207627|Superiority or Other||Mean Difference (Net)|-0.99||||0.021||95.0|-1.83|-0.15|||t-test, 2 sided||||
1744199|NCT00408876|3207627|Superiority or Other||Mean Difference (Net)|-0.68||||0.052||95.0|-1.37|0.01|||t-test, 2 sided||||
1744200|NCT00408876|3207627|Superiority or Other||Mean Difference (Net)|-0.68||||0.052||95.0|-1.36|0.0|||t-test, 2 sided||||
1744201|NCT00408876|3207627|Superiority or Other||Mean Difference (Net)|0.31||||0.464||95.0|-0.52|1.14|||t-test, 2 sided||||
1744202|NCT00408876|3207628|Superiority or Other||Mean Difference (Net)|-0.11||||0.442||95.0|-0.4|0.17|||t-test, 2 sided||||
1744203|NCT00408876|3207628|Superiority or Other||Mean Difference (Net)|-0.53||||0.003||95.0|-0.87|-0.19|||t-test, 2 sided||||
1744204|NCT00408876|3207628|Superiority or Other||Mean Difference (Net)|-0.42||||0.018||95.0|-0.76|-0.07|||t-test, 2 sided||||
1744205|NCT00408876|3207628|Superiority or Other||Mean Difference (Net)|-0.53|||<|0.001||95.0|-0.81|-0.24|||t-test, 2 sided||||
1744206|NCT00408876|3207628|Superiority or Other||Mean Difference (Net)|-0.41|||<|0.004||95.0|-0.7|-0.13|||t-test, 2 sided||||
1744207|NCT00408876|3207628|Superiority or Other||Mean Difference (Net)|0.0|||<|0.984||95.0|-0.34|0.34|||t-test, 2 sided||||
1744208|NCT00408876|3207629|Superiority or Other||Mean Difference (Net)|0.05||||0.859||95.0|-0.54|0.65|||t-test, 2 sided||||
1744209|NCT00408876|3207629|Superiority or Other||Mean Difference (Net)|-0.64||||0.083||95.0|-1.36|0.08|||t-test, 2 sided||||
1744210|NCT00408876|3207629|Superiority or Other||Mean Difference (Net)|-0.69||||0.062||95.0|-1.41|0.03|||t-test, 2 sided||||
1744211|NCT00408876|3207629|Superiority or Other||Mean Difference (Net)|-0.3||||0.314||95.0|-0.9|0.29|||t-test, 2 sided||||
1744212|NCT00408876|3207629|Superiority or Other||Mean Difference (Net)|-0.36||||0.232||95.0|-0.95|0.23|||t-test, 2 sided||||
1744213|NCT00408876|3207629|Superiority or Other||Mean Difference (Net)|0.33||||0.365||95.0|-0.39|1.05|||t-test, 2 sided||||
1744214|NCT00408876|3207630|Superiority or Other||Mean Difference (Net)|-0.33||||0.232||95.0|-0.86|0.21|||t-test, 2 sided||||
1744215|NCT00408876|3207630|Superiority or Other||Mean Difference (Net)|-0.71||||0.034||95.0|-1.36|-0.05|||t-test, 2 sided||||
1744216|NCT00408876|3207630|Superiority or Other||Mean Difference (Net)|-0.38||||0.253||95.0|-1.03|0.27|||t-test, 2 sided||||
1744217|NCT00408876|3207630|Superiority or Other||Mean Difference (Net)|-0.56||||0.04||95.0|-1.1|-0.03|||t-test, 2 sided||||
1744218|NCT00408876|3207630|Superiority or Other||Mean Difference (Net)|-0.23||||0.384||95.0|-0.76|0.29|||t-test, 2 sided||||
1744219|NCT00408876|3207630|Superiority or Other||Mean Difference (Net)|0.15||||0.657||95.0|-0.5|0.79|||t-test, 2 sided||||
1744220|NCT00408876|3207631|Superiority or Other||Mean Difference (Net)|-0.15||||0.813||95.0|-1.35|1.06|||t-test, 2 sided||||
1744221|NCT00408876|3207631|Superiority or Other||Mean Difference (Net)|-0.59||||0.397||95.0|-1.96|0.78|||t-test, 2 sided||||
1744222|NCT00408876|3207631|Superiority or Other||Mean Difference (Net)|-0.45||||0.526||95.0|-1.83|0.94|||t-test, 2 sided||||
1744223|NCT00408876|3207631|Superiority or Other||Mean Difference (Net)|-1.56||||0.01||95.0|-2.74|-0.38|||t-test, 2 sided||||
1744224|NCT00408876|3207631|Superiority or Other||Mean Difference (Net)|-1.41||||0.019||95.0|-2.59|-0.24|||t-test, 2 sided||||
1744225|NCT00408876|3207631|Superiority or Other||Mean Difference (Net)|-0.97||||0.161||95.0|-2.32|0.39|||t-test, 2 sided||||
1744226|NCT00408876|3207632|Superiority or Other||Mean Difference (Net)|0.22||||0.21||95.0|-0.13|0.57|||t-test, 2 sided||||
1744227|NCT00408876|3207632|Superiority or Other||Mean Difference (Net)|-0.06||||0.778||95.0|-0.48|0.36|||t-test, 2 sided||||
1744228|NCT00408876|3207632|Superiority or Other||Mean Difference (Net)|-0.28||||0.183||95.0|-0.7|0.13|||t-test, 2 sided||||
1744229|NCT00408876|3207632|Superiority or Other||Mean Difference (Net)|-0.27||||0.124||95.0|-0.61|0.07|||t-test, 2 sided||||
1744230|NCT00408876|3207632|Superiority or Other||Mean Difference (Net)|-0.49||||0.005||95.0|-0.83|-0.15|||t-test, 2 sided||||
1744231|NCT00408876|3207632|Superiority or Other||Mean Difference (Net)|-0.21||||0.318||95.0|-0.62|0.2|||t-test, 2 sided||||
1744232|NCT00408876|3207633|Superiority or Other|||||||0.333|||||||Repeated Measures||||
1744233|NCT00408876|3207633|Superiority or Other|||||||0.451|||||||Repeated Measures||||
1744234|NCT00408876|3207633|Superiority or Other|||||||0.964|||||||Repeated Measures||||
1744235|NCT00408876|3207633|Superiority or Other|||||||0.084|||||||Repeated Measures||||
1744236|NCT00408876|3207633|Superiority or Other|||||||0.447|||||||Repeated Measures||||
1744237|NCT00408876|3207633|Superiority or Other|||||||0.503|||||||Repeated Measures||||
1744238|NCT00408694|3207642|Other|||||||||||||||||Null hypothesis, H0: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≤ 0.05. Alternative hypothesis, HA: Incidence of patients with either grade 4 hemorrhage or any grade 5 adverse event for the protocol treatment regimen ≥ 0.15.|If 3 of the first 14 patients or 4 of the first 42 patients experience the specified adverse events, then the regimen is considered unacceptable as calculated by the Fleming method for a two-stage design with type I error and the statistical power were set at 0.14 and 0.83, respectively.
1744239|NCT00408629|3207657|Superiority or Other|||||||0.006||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744298|NCT00407797|3207760|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Anxiety: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744240|NCT00408629|3207658|Superiority or Other|||||||0.007||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744241|NCT00408629|3207659|Superiority or Other|||||||0.002||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744242|NCT00408629|3207660|Superiority or Other|||||||0.035||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744243|NCT00408629|3207661|Superiority or Other|||||||0.006||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744244|NCT00408629|3207662|Superiority or Other|||||||0.028||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744245|NCT00408629|3207663|Superiority or Other|||||||0.058||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744246|NCT00408629|3207664|Superiority or Other|||||||0.035||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744247|NCT00408629|3207665|Superiority or Other|||||||0.013||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744248|NCT00408629|3207666|Superiority or Other|||||||0.009||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744249|NCT00408629|3207667|Superiority or Other|||||||0.032||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure were needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744250|NCT00408629|3207668|Superiority or Other||||||<|0.001||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744299|NCT00407797|3207761|Superiority or Other|||||||0.1905|||||||t-test, 2 sided|||LOCF; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744300|NCT00407797|3207761|Superiority or Other|||||||0.2187|||||||t-test, 2 sided|||Week 21; change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744419|NCT00407537|3207844|Superiority or Other||Mean Difference (Final Values)|-1.61|||<|0.011|2-Sided|95.0|-2.86|-0.37|||Mixed-effect linear model||||
1744251|NCT00408629|3207669|Superiority or Other|||||||0.002||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744252|NCT00408629|3207670|Superiority or Other||||||<|0.001||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744253|NCT00408629|3207671|Superiority or Other|||||||0.047||||||Testing of ranked secondary measures was only started if significant group differences existed for both co-primary measures. Significant results for higher-ranked measure was needed to test next lower-ranked measure to control for multiple testing.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||The Cochran-Mantel-Haenszel test was used to test the null hypothesis of no difference between adalimumab and placebo. Treatment differences were deemed statistically significant at a significance level of 0.05.|
1744254|NCT00408629|3207672|Superiority or Other|||||||0.004||||||Testing for ranked co-primary endpoints occurred in hierarchical order to control for multiple testing. Week 8 remission rate was tested first. If a significant difference in group rates was found at alpha=0.05, Week 52 rate was tested at alpha=0.05.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||Assuming that 5% of the subjects in the placebo group achieve clinical remission at Week 52 or Week 8, a sample size of 250 in each treatment group will be adequate to detect a difference of at least 7 percentage points from the adalimumab group using Chi squared test with 80% power at a 0.05 two-sided significance level.|
1744255|NCT00408629|3207673|Superiority or Other|||||||0.019||||||Testing for ranked co-primary endpoints occurred in hierarchical order to control for multiple testing. Week 8 remission rate was tested first. If a significant difference in group rates was found at alpha=0.05, Week 52 rate was tested at alpha=0.05.|Cochran-Mantel-Haenszel|Stratification levels for Cochran-Mantel-Haenszel = prior anti-TNF versus anti-TNF-naive.||Assuming that 5% of the subjects in the placebo group achieve clinical remission at Week 52 or Week 8, a sample size of 250 in each treatment group will be adequate to detect a difference of at least 7 percentage points from the adalimumab group using Chi squared test with 80% power at a 0.05 two-sided significance level.|
1744256|NCT00408499|3207688|Other|Maximum tolerated dose was derived from toxicity data obtained from dose level 1-4.|Maximum tolerated dose|4.0|||||2-Sided||||||||Maximum tolerated dose was determined to be dose level 4: 150 mg Erlotinib, 250 mg/m2 Cetuximab||
1744257|NCT00408421|3207692|Superiority or Other||Mean Difference (Net)|-0.54||||0.107||95.0|-1.2|0.12||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744258|NCT00408421|3207693|Superiority or Other||Mean Difference (Net)|3.16||||0.069||95.0|-0.25|6.56||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744259|NCT00408421|3207694|Superiority or Other||Mean Difference (Net)|1.09||||0.326||95.0|-1.1|3.28||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744260|NCT00408421|3207695|Superiority or Other||Mean Difference (Net)|0.8||||0.459||95.0|-1.32|2.92||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA||Mean Difference = Duloxetine minus Placebo|An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744261|NCT00408421|3207696|Superiority or Other|||||||0.026||||||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA|ANOVA on ranked data.||An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744301|NCT00407797|3207762|Superiority or Other|||||||0.0316|||||||t-test, 2 sided|||LOCF: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744302|NCT00407797|3207762|Superiority or Other|||||||0.0465|||||||t-test, 2 sided|||Week 21: Quantity of Sleep. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744262|NCT00408421|3207697|Superiority or Other|||||||0.003||||||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANOVA|ANOVA on ranked data.||An analysis of variance (ANOVA) model was used which contains the terms of treatment and investigator. Rank-transformed data will be used in the analysis given the view that the change scores for most of the laboratory analytes are not normally distributed. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744263|NCT00408421|3207698|Superiority or Other||Mean Difference (Net)|-0.47||||0.193||95.0|-1.17|0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744264|NCT00408421|3207699|Superiority or Other||Mean Difference (Net)|-0.23||||0.641||95.0|-1.19|0.74||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744265|NCT00408421|3207700|Superiority or Other||Mean Difference (Net)|0.06|||<|0.001||95.0|0.03|0.1||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744266|NCT00408421|3207701|Superiority or Other||Mean Difference (Net)|1.87||||0.08||95.0|-0.22|3.96||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744267|NCT00408421|3207702|Superiority or Other||Mean Difference (Net)|1.83||||0.088||95.0|-0.28|3.94||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744268|NCT00408421|3207703|Superiority or Other|||||||0.075|||||||Fisher Exact|||This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.|
1744269|NCT00408421|3207704|Superiority or Other|||||||0.033|||||||Fisher Exact|||This study will also have at least 85% power to detect a treatment group difference of 25% in the response rates (≥30% reduction from baseline) based on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups.|
1744270|NCT00408421|3207705|Superiority or Other||Mean Difference (Net)|-0.56||||0.029||95.0|-1.06|-0.06||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744271|NCT00408421|3207706|Superiority or Other||Mean Difference (Net)|-0.78||||0.015||95.0|-1.4|-0.15||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744272|NCT00408421|3207707|Superiority or Other||Mean Difference (Net)|-0.64||||0.033||95.0|-1.23|-0.05||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744303|NCT00407797|3207762|Superiority or Other|||||||0.0898|||||||t-test, 2 sided|||LOCF: 9-Item Overall Sleep Problem Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744273|NCT00408421|3207708|Superiority or Other||Mean Difference (Net)|-0.29||||0.287||95.0|-0.82|0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744274|NCT00408421|3207709|Superiority or Other||Mean Difference (Net)|-0.51||||0.093||95.0|-1.1|0.08||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744275|NCT00408421|3207710|Superiority or Other||Mean Difference (Net)|-0.63||||0.049||95.0|-1.25|0.0||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744276|NCT00408421|3207711|Superiority or Other||Mean Difference (Net)|-0.4||||0.164||95.0|-0.97|0.17||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744277|NCT00408421|3207712|Superiority or Other||Mean Difference (Net)|-0.71||||0.019||95.0|-1.3|-0.12||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744278|NCT00408421|3207713|Superiority or Other||Mean Difference (Net)|-0.91||||0.003||95.0|-1.5|-0.32||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744279|NCT00408421|3207714|Superiority or Other||Mean Difference (Net)|-0.97|||<|0.001||95.0|-1.52|-0.42||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744280|NCT00408421|3207715|Superiority or Other||Mean Difference (Net)|-0.76||||0.004||95.0|-1.28|-0.24||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744281|NCT00408421|3207716|Superiority or Other||Mean Difference (Net)|-1.06|||<|0.001||95.0|-1.66|-0.46||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744282|NCT00408421|3207717|Superiority or Other||Mean Difference (Net)|-0.35||||0.001||95.0|-0.56|-0.14||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744304|NCT00407797|3207762|Superiority or Other|||||||0.1698|||||||t-test, 2 sided|||Week 21: 9-Item Overall Sleep Problems Index. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744283|NCT00408421|3207718|Superiority or Other||Mean Difference (Net)|-0.87||||0.039||95.0|-1.69|-0.05||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744284|NCT00408421|3207719|Superiority or Other||||||<|0.001||||||P-value for treatment effect at last visit. Effects evaluated based on 2-sided significance level=0.05. Model: treatment, NSAID use, investigator, week, treatment-by-week interaction, baseline score and baseline-by-week interaction.|Mixed-Effects Model Repeated Measures|No adjustments for multiple comparisons were made.|||
1744285|NCT00408421|3207720|Superiority or Other||Mean Difference (Net)|-0.83||||0.005||95.0|-1.4|-0.25||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744286|NCT00408421|3207721|Superiority or Other||Mean Difference (Net)|-6.42||||0.004||95.0|-10.72|-2.11||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744287|NCT00408421|3207722|Superiority or Other||Mean Difference (Net)|-5.18||||0.001||95.0|-8.33|-2.03||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744288|NCT00408421|3207723|Superiority or Other||Mean Difference (Net)|-0.65||||0.004||95.0|-1.09|-0.22||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744289|NCT00408421|3207724|Superiority or Other||Mean Difference (Net)|-1.41||||0.003||95.0|-2.33|-0.48||P-value for Change from Baseline. Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made. Change=Endpoint-Baseline.|ANCOVA||Mean Difference = Duloxetine minus Placebo|An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), the outcome score at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean change from baseline to the endpoint of the outcome measure.|
1744290|NCT00408421|3207725|Superiority or Other||Mean Difference (Net)|-0.53||||0.001||95.0|-0.84|-0.21||Treatment effects and interaction effects were evaluated based on a two-sided significance level of 0.05. No adjustments for multiple comparisons were made.|ANCOVA|||An analysis of covariance (ANCOVA) model was used which contains the terms of treatment, NSAID use (Yes/No), PGI severity at baseline, and investigator. Type III sum-of-squares for the least-squares mean (LSMean) was used to test the null hypothesis that there is no treatment difference on the mean outcome measure at endpoint.|
1744291|NCT00408421|3207726|Superiority or Other||||||<|0.001||||||P-value for treatment effect at last visit. Effects evaluated based on 2-sided significance level=0.05. Model: treatment, NSAID use, investigator, week, treatment-by-week interaction, baseline score and baseline-by-week interaction.|Mixed-Effects Model Repeated Measures|No adjustments for multiple comparisons were made.||Null hypothesis: the difference in 24-hour average pain score between duloxetine and placebo treatment groups at last visit of treatment phase is zero. This study will have at least 80% power to detect a treatment group difference of 1.0 point in the baseline-to-endpoint mean change on the weekly mean of 24-hour average pain severity between duloxetine and placebo treatment groups based on Baseline Observation Carried Forward (BOCF).|
1744292|NCT00408317|3207739|Superiority or Other||Mean Difference (Final Values)|25.68|||<|0.0001|||||||Mixed Models Analysis|||P-values are from a semi-parametric mixed model on ranked CNA% values including sequence, period, and treatment group as fixed effects, and participant ID as random effect.|
1744293|NCT00408317|3207740|Superiority or Other||Mean Difference (Net)|34.74|||<|0.0001|||||||Mixed Models Analysis|||P-values are from a semi-parametric mixed model on ranked CFA% values including sequence, period, and treatment group as fixed effects; participant identification (ID) as random effect.|
1744294|NCT00408200|3207741|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1744295|NCT00407797|3207760|Superiority or Other|||||||0.0846|||||||t-test, 2 sided|||Depression: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744296|NCT00407797|3207760|Superiority or Other|||||||0.0799|||||||t-test, 2 sided|||Depression: Week 21. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744297|NCT00407797|3207760|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Anxiety: LOCF. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744305|NCT00407797|3207762|Superiority or Other|||||||0.7669|||||||t-test, 2 sided|||LOCF: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744306|NCT00407797|3207762|Superiority or Other|||||||0.8928|||||||t-test, 2 sided|||Week 21: Somnolence. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744307|NCT00407797|3207762|Superiority or Other|||||||0.0944|||||||t-test, 2 sided|||LOCF: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744308|NCT00407797|3207762|Superiority or Other|||||||0.1091|||||||t-test, 2 sided|||Week 21: Sleep Adequacy. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744309|NCT00407797|3207762|Superiority or Other|||||||0.9092|||||||t-test, 2 sided|||LOCF: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744310|NCT00407797|3207762|Superiority or Other|||||||0.8173|||||||t-test, 2 sided|||Week 21: Awaken Short of Breath. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744311|NCT00407797|3207762|Superiority or Other|||||||0.4736|||||||t-test, 2 sided|||LOCF: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744312|NCT00407797|3207762|Superiority or Other|||||||0.6743|||||||t-test, 2 sided|||Week 21: Snoring. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744313|NCT00407797|3207762|Superiority or Other|||||||0.035|||||||t-test, 2 sided|||LOCF: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744314|NCT00407797|3207762|Superiority or Other|||||||0.0552|||||||t-test, 2 sided|||Week 21: Sleep Disturbance. Change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744315|NCT00407797|3207768|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Participants with > 6 seizures during Baseline Period.|
1744316|NCT00407797|3207768|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Participants with <= 6 seizures during Baseline period.|
1744317|NCT00407797|3207769|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Percent change evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744318|NCT00407797|3207770|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1744319|NCT00407797|3207771|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Percent change from baseline evaluated by a one-sample two-sided t-test comparing the difference to zero.|
1744320|NCT00407745|3207780|Superiority or Other||LS mean difference|-0.99|Standard Error of the Mean|0.447||0.0279|2-Sided|95.0|-1.87|-0.11||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline HADS - Depression as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744321|NCT00407745|3207781|Superiority or Other||LS mean difference|-0.68|Standard Error of the Mean|0.433||0.1164|2-Sided|95.0|-1.54|0.17||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline HADS - Anxiety as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744322|NCT00407745|3207782|Superiority or Other||Odds Ratio (OR)|2.81||||0.0024|2-Sided|95.0|1.443|5.491||Significance was declared if p-value <=0.05|Regression, Logistic|Logistic Regression Model included Pooled Center and Treatment as the categorical factors, and Optimal Sleep Score at Baseline as the covariate.||Null hypothesis – The rate of subjects with optimal sleep for the pregabain group was equal to the rate of subjects with optimal sleep for the placebo group; Alternative hypothesis – The rate of subjects with optimal sleep for the pregabain group was not equal to the rate of subjects with optimal sleep for the placebo group.|
1744323|NCT00407745|3207783|Superiority or Other||LS mean difference|3.02|Standard Error of the Mean|2.77||0.2761|2-Sided|95.0|-2.44|8.49||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Somnolence as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744324|NCT00407745|3207784|Superiority or Other||LS mean difference|0.38|Standard Error of the Mean|0.189||0.0436|2-Sided|95.0|0.01|0.76||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep Quantity as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744325|NCT00407745|3207785|Superiority or Other||LS mean difference|-5.14|Standard Error of the Mean|2.417||0.0347|2-Sided|95.0|-9.91|-0.37||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included baseline MOS - Awaken Short of Breath or with headache as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744326|NCT00407745|3207786|Superiority or Other||LS mean difference|5.7|Standard Error of the Mean|3.501||0.1048|2-Sided|95.0|-1.2|12.61||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Snoring as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744420|NCT00407537|3207845|Superiority or Other||Mean Difference (Final Values)|-3.15|||<|0.007|2-Sided|95.0|-5.42|-0.88|||Mixed-effect linear model||||
1744327|NCT00407745|3207787|Superiority or Other||LS mean difference|5.78|Standard Error of the Mean|3.492||0.0998|2-Sided|95.0|-1.11|12.66||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep Adequacy as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744328|NCT00407745|3207788|Superiority or Other||LS mean difference|-8.67|Standard Error of the Mean|2.985||0.0041|2-Sided|95.0|-14.55|-2.78||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline MOS - Sleep disturbance as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744329|NCT00407745|3207789|Superiority or Other||LS mean difference|-4.89|Standard Error of the Mean|2.182||0.0262|2-Sided|95.0|-9.19|-0.59||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline MOS 9-item Sleep Problems Index as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744330|NCT00407745|3207790|Superiority or Other|||||||0.3107||||||p-values are adjusted for baseline score. Significance was declared if p-value <=0.05.|Cochran-Mantel-Haenszel|||Null hypothesis – The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis – The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.|
1744331|NCT00407745|3207791|Superiority or Other|||||||0.0536||||||p-values are adjusted for baseline score. Significance was declared if p-value <=0.05.|Cochran-Mantel-Haenszel|||Null hypothesis – The rate of subjects with improvement for the pregabain group was equal to the rate of subjects with improvement for the placebo group; Alternative hypothesis – The rate of subjects with improvement for the pregabain group was not equal to the rate of subjects with improvement for the placebo group.|
1744332|NCT00407745|3207792|Superiority or Other||LS mean difference|-0.28|Standard Error of the Mean|0.402||0.4915|2-Sided|95.0|-1.07|0.52||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 12 - Tingling~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744333|NCT00407745|3207792|Superiority or Other||LS mean difference|-0.35|Standard Error of the Mean|0.387||0.361|2-Sided|95.0|-1.12|0.41||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 11 - Pins and needles~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744334|NCT00407745|3207792|Superiority or Other||LS mean difference|-0.14|Standard Error of the Mean|0.352||0.6851|2-Sided|95.0|-0.84|0.55||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 10 - By something cold~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744335|NCT00407745|3207792|Superiority or Other||LS mean difference|-0.09|Standard Error of the Mean|0.33||0.7821|2-Sided|95.0|-0.74|0.56||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 9 - By pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744336|NCT00407745|3207792|Superiority or Other||LS mean difference|0.15|Standard Error of the Mean|0.353||0.672|2-Sided|95.0|-0.55|0.85||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 8 - By light touching~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744337|NCT00407745|3207792|Superiority or Other||LS mean difference|-0.49|Standard Error of the Mean|0.376||0.1912|2-Sided|95.0|-1.23|0.25||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 6 - Stabbing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744338|NCT00407745|3207792|Superiority or Other||LS mean difference|-0.38|Standard Error of the Mean|0.389||0.3239|2-Sided|95.0|-1.15|0.38||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 5 - Electric shocks~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744451|NCT00407511|3207863|Superiority or Other||Mean Difference (Final Values)|-4.1|Standard Error of the Mean|0.2|<|0.0001||95.0|-4.5|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: subjects were only included if their visit fell within the computed week (>= Day 78)|
1744339|NCT00407745|3207792|Superiority or Other||LS mean difference|-0.76|Standard Error of the Mean|0.393||0.0538|2-Sided|95.0|-1.54|0.01||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 3 - Pain like pressure~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744340|NCT00407745|3207792|Superiority or Other||LS mean difference|-0.63|Standard Error of the Mean|0.377||0.0976|2-Sided|95.0|-1.37|0.12||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 2 - Squeezing pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744341|NCT00407745|3207792|Superiority or Other||LS mean difference|-0.37|Standard Error of the Mean|0.383||0.3312|2-Sided|95.0|-1.13|0.38||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Individual Item Score as covariate and pooled center and treatment as fixed (class) cofactors.||"Item 1 - Burning pain~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744342|NCT00407745|3207793|Superiority or Other||LS mean difference|-0.03|Standard Error of the Mean|0.034||0.3731|2-Sided|95.0|-0.1|0.04||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Paresthesia/Dysesthesia as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744343|NCT00407745|3207794|Superiority or Other||LS mean difference|0.0|Standard Error of the Mean|0.028||0.8911|2-Sided|95.0|-0.06|0.05||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Evoked pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744344|NCT00407745|3207795|Superiority or Other||LS mean difference|-0.05|Standard Error of the Mean|0.033||0.137|2-Sided|95.0|-0.12|0.02||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Paroxysmal Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744345|NCT00407745|3207796|Superiority or Other||LS mean difference|-0.07|Standard Error of the Mean|0.033||0.044|2-Sided|95.0|-0.13|0.0||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Pressing Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744346|NCT00407745|3207797|Superiority or Other||LS mean difference|-0.04|Standard Error of the Mean|0.038||0.3312|2-Sided|95.0|-0.11|0.04||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - Burning Spontaneous Pain as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744347|NCT00407745|3207798|Superiority or Other||LS mean difference|-0.04|Standard Error of the Mean|0.025||0.1377|2-Sided|95.0|-0.09|0.01||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline NPSI - 12 Items Total Intensity Score as covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744348|NCT00407745|3207799|Superiority or Other||LS mean difference|-0.53|Standard Error of the Mean|0.412||0.2005|2-Sided|95.0|-1.34|0.28||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744349|NCT00407745|3207799|Superiority or Other||LS mean difference|-0.44|Standard Error of the Mean|0.549||0.4257|2-Sided|95.0|-1.53|0.65||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Hyperalgesia Subscales as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744350|NCT00407745|3207800|Superiority or Other||LS mean difference|-0.55|Standard Error of the Mean|0.368||0.136|2-Sided|95.0|-1.28|0.18||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744475|NCT00406848|3207885|Superiority or Other|||||||0.016||||||p-value is for Successful Treatment Outcome defined with HAMD-17 ≤10 criteria.|Fisher Exact||||
1744351|NCT00407745|3207800|Superiority or Other||LS mean difference|-0.48|Standard Error of the Mean|0.472||0.3123|2-Sided|95.0|-1.42|0.46||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Cold Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744352|NCT00407745|3207801|Superiority or Other||LS mean difference|0.23|Standard Error of the Mean|0.337||0.4906|2-Sided|95.0|-0.43|0.9||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744353|NCT00407745|3207801|Superiority or Other||LS mean difference|-0.6|Standard Error of the Mean|0.539||0.2721|2-Sided|95.0|-1.67|0.48||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Temporal Summation to stimuli as covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744354|NCT00407745|3207802|Superiority or Other||LS mean difference|-0.33|Standard Error of the Mean|0.321||0.3113|2-Sided|95.0|-0.96|0.31||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744355|NCT00407745|3207802|Superiority or Other||LS mean difference|-0.46|Standard Error of the Mean|0.474||0.3362|2-Sided|95.0|-1.4|0.48||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Punctate Hyperalgesia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744356|NCT00407745|3207803|Superiority or Other||LS mean difference|-0.23|Standard Error of the Mean|0.322||0.4764|2-Sided|95.0|-0.87|0.41||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.||"Below level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744357|NCT00407745|3207803|Superiority or Other||LS mean difference|-0.22|Standard Error of the Mean|0.379||0.5689|2-Sided|95.0|-0.97|0.54||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Dynamic Mechanical Allodynia as covariate and pooled center and treatment as fixed (class) cofactors.||"At/Above level~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744358|NCT00407745|3207804|Superiority or Other||LS mean difference|-0.61|Standard Error of the Mean|0.34||0.0747|2-Sided|95.0|-1.28|0.06||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"Below level: more than 2 dermatomes below the NLI.~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744359|NCT00407745|3207804|Superiority or Other||LS mean difference|-0.17|Standard Error of the Mean|0.448||0.7103|2-Sided|95.0|-1.06|0.72||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline QANeP - Static Mechanical Allodynia as a covariate and pooled center and treatment as fixed (class) cofactors.||"At/above level: within 2 dermatomes above or below the neurological level of injury (NLI).~Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group."|
1744360|NCT00407745|3207805|Superiority or Other||LS Mean Difference|-0.55|Standard Error of the Mean|0.269||0.0438|2-Sided|95.0|-1.08|-0.02||Significance was declared if p-value <=0.05|ANCOVA|ANCOVA model included terms of baseline mBPI-10 Total Score as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744361|NCT00407745|3207806|Superiority or Other||LS mean difference|-1.06|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.51|-0.61||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 16.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744362|NCT00407745|3207806|Superiority or Other||LS mean difference|-1.08|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.53|-0.63||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 15.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744363|NCT00407745|3207806|Superiority or Other||LS mean difference|-0.96|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.41|-0.51||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 14.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744364|NCT00407745|3207806|Superiority or Other||LS mean difference|-0.92|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.38|-0.47||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 13.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744365|NCT00407745|3207806|Superiority or Other||LS mean difference|-0.92|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.37|-0.47||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 12.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744366|NCT00407745|3207806|Superiority or Other||LS mean difference|-0.94|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.39|-0.49||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 11.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744367|NCT00407745|3207806|Superiority or Other||LS mean difference|-1.08|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.53|-0.63||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 10.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744368|NCT00407745|3207806|Superiority or Other||LS mean difference|-0.94|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.39|-0.5||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 9.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744369|NCT00407745|3207806|Superiority or Other||LS mean difference|-0.9|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.35|-0.46||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 8.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744370|NCT00407745|3207806|Superiority or Other||LS mean difference|-0.91|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.35|-0.47||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 7.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744371|NCT00407745|3207806|Superiority or Other||LS mean difference|-0.93|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.37|-0.48||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 6.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744372|NCT00407745|3207806|Superiority or Other||LS mean difference|-0.94|Standard Error of the Mean|0.23|<|0.0001|2-Sided|95.0|-1.38|-0.49||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 5.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744373|NCT00407745|3207806|Superiority or Other||LS mean difference|-0.76|Standard Error of the Mean|0.23|<|0.0008|2-Sided|95.0|-1.2|-0.32||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 4.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744374|NCT00407745|3207806|Superiority or Other||LS mean difference|-0.8|Standard Error of the Mean|0.22|<|0.0004|2-Sided|95.0|-1.24|-0.36||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 3.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744476|NCT00406848|3207885|Superiority or Other|||||||0.11||||||p-value is for Successful Treatment Outcome defined with HAMD-17 ≤7 criteria.|Fisher Exact||||
1744375|NCT00407745|3207806|Superiority or Other||LS mean difference|-0.87|Standard Error of the Mean|0.22|<|0.0001|2-Sided|95.0|-1.31|-0.43||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744376|NCT00407745|3207806|Superiority or Other||LS mean difference|-0.79|Standard Error of the Mean|0.22|<|0.0004|2-Sided|95.0|-1.23|-0.35||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 1.~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, pooled center, time (week), baseline score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744377|NCT00407745|3207807|Superiority or Other||Odds Ratio (OR)|2.24||||0.0256|2-Sided|95.0|1.103|4.546||Significance was declared if p-value <=0.05|Regression, Logistic|Logistic regression used terms for treatment, baseline pain score as covariate, baseline PCS total score, and pooled center as cofactor.||Null hypothesis – The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis – The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group.|
1744378|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.76|Standard Error of the Mean|0.23||0.0011|2-Sided|95.0|-1.22|-0.3||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 16~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744379|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.69|Standard Error of the Mean|0.23||0.003|2-Sided|95.0|-1.15|-0.24||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 15~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744380|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.66|Standard Error of the Mean|0.23||0.0048|2-Sided|95.0|-1.11|-0.2||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 14~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744381|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.57|Standard Error of the Mean|0.23||0.015|2-Sided|95.0|-1.02|-0.11||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 13~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744382|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|0.23||0.0328|2-Sided|95.0|-0.95|-0.04||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 12~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744383|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.62|Standard Error of the Mean|0.23||0.0076|2-Sided|95.0|-1.08|-0.17||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 11~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744384|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.69|Standard Error of the Mean|0.23||0.0031|2-Sided|95.0|-1.14|-0.23||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 10~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744385|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.64|Standard Error of the Mean|0.23||0.0058|2-Sided|95.0|-1.09|-0.18||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 9~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744416|NCT00407537|3207841|Superiority or Other||Mean Difference (Final Values)|-38.94|||<|0.001|2-Sided|95.0|-43.71|-34.17||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC|
1744417|NCT00407537|3207842|Superiority or Other||Mean Difference (Final Values)|-3.17|||<|0.001|2-Sided|95.0|-4.42|-1.92|||Mixed-effect linear model||||
1744386|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.66|Standard Error of the Mean|0.23||0.0041|2-Sided|95.0|-1.11|-0.21||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 8~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744387|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.69|Standard Error of the Mean|0.23||0.0027|2-Sided|95.0|-1.14|-0.24||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 7~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744388|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.72|Standard Error of the Mean|0.23||0.0018|2-Sided|95.0|-1.17|-0.27||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 6~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744389|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.81|Standard Error of the Mean|0.23||0.0004|2-Sided|95.0|-1.26|-0.36||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 5~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744390|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.66|Standard Error of the Mean|0.23||0.004|2-Sided|95.0|-1.1|-0.21||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 4~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744391|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.54|Standard Error of the Mean|0.23||0.0185|2-Sided|95.0|-0.98|-0.09||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 3~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744392|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.67|Standard Error of the Mean|0.23||0.0033|2-Sided|95.0|-1.11|-0.22||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 2~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744393|NCT00407745|3207808|Superiority or Other||LS Mean Difference|-0.49|Standard Error of the Mean|0.23||0.0295|2-Sided|95.0|-0.94|-0.05||Significance was declared if p-value <=0.05|Mixed Models Analysis|||"Week 1~A longitudinal analysis of weekly mean changes using repeated measures mixed models which compared treatments at each week and the last scheduled study week based on this model (to assess durability of treatment effect) was used.~Effects for treatment, study center, time (week), baseline pain score, baseline PCS total score, and treatment by time interaction were included as covariates. The covariance structure was compound-symmetric."|
1744394|NCT00407745|3207809|Superiority or Other||LS Mean Difference|-1.08|Standard Error of the Mean|0.265|<|0.0001|2-Sided|95.0|-1.6|-0.56||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|ANCOVA|ANCOVA model included baseline sleep interference score as a covariate and pooled center and treatment as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744395|NCT00407745|3207810|Superiority or Other|||||||0.0006||||||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|Cochran-Mantel-Haenszel|Modified ridit transformation with the Cochran-Mantel- Haenszel test was used with adjusting for pooled center.||Null hypothesis – The raw mean score for the pregabain group was equal to the raw mean score for the placebo group; Alternative hypothesis – The raw mean score for the pregabain group was not equal to the raw mean score for the placebo group.|
1744396|NCT00407745|3207811|Superiority or Other||Odds Ratio (OR)|1.85||||0.039|2-Sided|95.0|1.032|3.328||Serial gate-keeping multiple testing was used. If primary comparison for DAAC was significant, then variables were assessed in hierarchical manner. Significance was declared if unadjusted p-value at 0.05 level and preceding tests were significant.|Regression, Logistic|Logistic regression model used terms for baseline pain score and baseline PCS total score as covariate, and pooled center and treatment as cofactor.||Null hypothesis – The rate of responder for the pregabain group was equal to the rate of responder for the placebo group; Alternative hypothesis – The rate of responder for the pregabain group was not equal to the rate of responder for the placebo group|
1745100|NCT00405392|3208175|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1744397|NCT00407745|3207812|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|0.255||0.0066|2-Sided|95.0|-1.2|-0.2||Serial gate-keeping multiple testing procedure was used. If primary comparison for DAAC was significant, then variables were assessed in a hierarchical manner. Significance was declared if unadjusted p-value was significant at 0.05 level (<=0.05).|ANCOVA|ANCOVA model included baseline severity (pain) and baseline PCS as covariates and effects for treatment and pooled center as fixed (class) cofactors.||Null hypothesis - the mean of the measure for the pregabalin group was the same as the mean of the measure for the placebo group; Alternative hypothesis - the mean of the measure for the pregabalin group was different from the mean of the measure for the placebo group.|
1744398|NCT00407745|3207813|Superiority or Other||LS Mean Difference|-0.59|Standard Error of the Mean|0.198||0.0032|2-Sided|95.0|-0.98|-0.2||Significance was declared if the 2-tailed test for the difference between treatment groups was significant at the 0.05 level.|ANCOVA|||"Null hypothesis - the mean DAAC for the pregabalin group is equal to the mean DAAC for the placebo group; Alternative hypothesis - the mean DAAC for the placebo group differs from the mean DAAC for the pregabalin group.~ANCOVA model included baseline severity of pain and Baseline Pain Catastrophizing Scale (PCS) Total Score as covariates and pooled center and treatment as fixed (class) cofactors."|
1744399|NCT00407550|3207831|Superiority|||||||0.56|||||||Log Rank||||
1744400|NCT00407550|3207832|Superiority|||||||0.015|||||||Log Rank||||
1744401|NCT00407537|3207838|Superiority or Other||Mean Difference (Final Values)|-18.27|||<|0.001|2-Sided|95.0|-28.72|-7.81||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides|
1744402|NCT00407537|3207838|Superiority or Other||Mean Difference (Final Values)|0.58|||<|0.379|2-Sided|95.0|-0.71|1.86||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|mixed-effect linear model|||HDL|
1744403|NCT00407537|3207838|Superiority or Other||Mean Difference (Final Values)|-29.83|||<|0.001|2-Sided|95.0|-33.7|-25.95||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL|
1744404|NCT00407537|3207838|Superiority or Other||Mean Difference (Final Values)|-33.07|||<|0.001|2-Sided|95.0|-37.57|-28.56||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Total cholesterol|
1744405|NCT00407537|3207839|Superiority or Other||Mean Difference (Final Values)|-23.65|||<|0.001|2-Sided|95.0|-32.6|-14.7||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides|
1744406|NCT00407537|3207839|Superiority or Other||Mean Difference (Final Values)|0.99|||<|0.087|2-Sided|95.0|-0.14|2.13||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|mixed-effect linear model|||HDL|
1744407|NCT00407537|3207839|Superiority or Other||Mean Difference (Final Values)|-35.31|||<|0.001|2-Sided|95.0|-39.64|-30.99||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL|
1744408|NCT00407537|3207839|Superiority or Other||Mean Difference (Final Values)|-38.94|||<|0.001|2-Sided|95.0|-43.71|-34.17||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC|
1744409|NCT00407537|3207840|Superiority or Other||Mean Difference (Final Values)|-18.27|||<|0.001|2-Sided|95.0|-28.72|-7.81||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||Triglycerides|
1744410|NCT00407537|3207840|Superiority or Other||Mean Difference (Final Values)|0.58|||<|0.379|2-Sided|95.0|-0.71|1.86||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||HDL|
1744411|NCT00407537|3207840|Superiority or Other||Mean Difference (Final Values)|-29.83|||<|0.001|2-Sided|95.0|-33.7|-25.95||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL|
1744412|NCT00407537|3207840|Superiority or Other||Mean Difference (Final Values)|-33.07|||<|0.001|2-Sided|95.0|-37.57|-28.56||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||TC|
1744413|NCT00407537|3207841|Superiority or Other||Mean Difference (Final Values)|-23.65|||<|0.001|2-Sided|95.0|-32.6|-14.7||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effects linear model|||Triglycerides|
1744414|NCT00407537|3207841|Superiority or Other||Mean Difference (Final Values)|0.99|||<|0.087|2-Sided|95.0|-0.14|2.13||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||HDL|
1744415|NCT00407537|3207841|Superiority or Other||Mean Difference (Final Values)|-35.31|||<|0.001|2-Sided|95.0|-39.64|-30.99||Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model|||LDL|
1744418|NCT00407537|3207843|Superiority or Other||Mean Difference (Final Values)|-5.75|||<|0.001|2-Sided|95.0|-8.0|-3.5|||Mixed-effect linear model||||
1745246|NCT00402987|3208367|Superiority or Other||||||<|0.001||||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor|||
1744421|NCT00407537|3207850|Superiority or Other||LSMean difference|-1.35|||<|0.001|2-Sided|95.0|-1.57|-1.14||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.||
1744422|NCT00407537|3207851|Superiority or Other||LSMean difference|-1.35|||<|0.001|2-Sided|95.0|-1.56|-1.15||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.||
1744423|NCT00407537|3207852|Superiority or Other||LSMean difference|-0.88|||<|0.001|2-Sided|95.0|-1.16|-0.59||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.||
1744424|NCT00407537|3207853|Superiority or Other||LSMean difference|-0.97|||<|0.001|2-Sided|95.0|-1.23|-0.72||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.||
1744425|NCT00407537|3207854|Superiority or Other||LSMean difference|-4.76|||<|0.001|2-Sided|95.0|-5.58|-3.93||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.||
1744426|NCT00407537|3207855|Superiority or Other||LSMean difference|-4.72|||<|0.001|2-Sided|95.0|-5.55|-3.89||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|Mixed-effect linear model||Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.|It was estimated that each study site would on average complete 8 evaluable participants, therefore enrolling 164 sites, 1968 participants would provide at least 90% power to detect a 10% relative reduction in the 10-year predicted risk of total CHD at 12 months (as calculated from the Framingham model) from the control arm based on a two-sided t-test with a 5% significance level.|
1744427|NCT00407511|3207858|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||EOT/LOCF value consists of the mean of the last 7 post-baseline sleep scores; mean change = arithmetic mean change; p-value: from single sample t-test.|
1744428|NCT00407511|3207858|Superiority or Other||Mean Difference (Final Values)|-3.4|Standard Error of the Mean|0.2|<|0.0001||95.0|-3.7|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.|
1744429|NCT00407511|3207858|Superiority or Other||Mean Difference (Final Values)|-3.4|Standard Error of the Mean|0.2|<|0.0001||95.0|-3.8|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Visit 11: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.|
1744430|NCT00407511|3207858|Superiority or Other||Mean Difference (Final Values)|-3.4|Standard Error of the Mean|0.2|<|0.0001||95.0|-3.7|-3.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 10: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.|
1744431|NCT00407511|3207858|Superiority or Other||Mean Difference (Final Values)|-3.3|Standard Error of the Mean|0.2|<|0.0001||95.0|-3.7|-2.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 9: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.|
1744432|NCT00407511|3207858|Superiority or Other||Mean Difference (Final Values)|-3.2|Standard Error of the Mean|0.2|<|0.0001||95.0|-3.6|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.|
1744433|NCT00407511|3207858|Superiority or Other||Mean Difference (Final Values)|-3.1|Standard Error of the Mean|0.2|<|0.0001||95.0|-3.5|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 7: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.|
1744434|NCT00407511|3207858|Superiority or Other||Mean Difference (Final Values)|-3.0|Standard Error of the Mean|0.2|<|0.0001||95.0|-3.4|-2.6|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 6: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.|
1744435|NCT00407511|3207858|Superiority or Other||Mean Difference (Final Values)|-2.9|Standard Error of the Mean|0.2|<|0.0001||95.0|-3.3|-2.6|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 5: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.|
1744436|NCT00407511|3207858|Superiority or Other||Mean Difference (Final Values)|-2.8|Standard Error of the Mean|0.2|<|0.0001||95.0|-3.2|-2.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.|
1744437|NCT00407511|3207858|Superiority or Other||Mean Difference (Final Values)|-2.5|Standard Error of the Mean|0.2|<|0.0001||95.0|-2.9|-2.2|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 3: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.|
1744438|NCT00407511|3207858|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|0.2|<|0.0001||95.0|-2.2|-1.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 2: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.|
1744439|NCT00407511|3207858|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.2|<|0.0001||95.0|-1.4|-0.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 1: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.|
1744440|NCT00407511|3207859|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||EOT/LOCF: last post-baseline assessment. Mean change= arithmetic mean change; p-value is from a single-sample t-test.|
1744441|NCT00407511|3207859|Superiority or Other||Mean Difference (Final Values)|-40.7|Standard Error of the Mean|2.4|<|0.0001||95.0|-45.5|-35.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 12 assessment only if their visit fell >=Day 78.|
1744442|NCT00407511|3207859|Superiority or Other||Mean Difference (Final Values)|-38.7|Standard Error of the Mean|2.4|<|0.0001||95.0|-43.4|-33.9|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 8 assessment only if their visit fell within Days 49 and 63.|
1744443|NCT00407511|3207860|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||EOT/LOCF: last post-baseline assessment. Mean change is the arithmetic mean change; p-value is from a single-sample t-test.|
1744444|NCT00407511|3207860|Superiority or Other||Mean Difference (Final Values)|-48.4|Standard Error of the Mean|2.2|<|0.0001||95.0|-52.8|-44.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 12 assessment if their visit fell >= Day 78.|
1744445|NCT00407511|3207860|Superiority or Other||Mean Difference (Final Values)|-45.8|Standard Error of the Mean|2.2|<|0.0001||95.0|-50.2|-41.4|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 8 assessment if their visit fell within Days 49 to 63.|
1744446|NCT00407511|3207860|Superiority or Other||Mean Difference (Final Values)|-40.9|Standard Error of the Mean|2.2|<|0.0001||95.0|-45.2|-36.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 4 assessment if their visit fell within days 25 to 35.|
1744447|NCT00407511|3207860|Superiority or Other||Mean Difference (Final Values)|-34.3|Standard Error of the Mean|2.1|<|0.0001||95.0|-38.5|-30.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 3: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 3 assessment if their visit fell within Days 18 to 24.|
1744448|NCT00407511|3207860|Superiority or Other||Median Difference (Final Values)|-28.2|Standard Error of the Mean|2.1|<|0.0001||95.0|-32.4|-24.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 2: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 2 assessment if their visit fell within Days 11 to 17.|
1744449|NCT00407511|3207860|Superiority or Other||Mean Difference (Final Values)|-18.1|Standard Error of the Mean|2.1|<|0.0001||95.0|-22.3|-14.0|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 1: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 1 assessment if their visit fell within Days 4 to 10.|
1744450|NCT00407511|3207863|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.|
1744474|NCT00406848|3207884|Superiority or Other|||||||0.511||||||p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744452|NCT00407511|3207863|Superiority or Other||Mean Difference (Final Values)|-3.8|Standard Error of the Mean|0.2|<|0.0001||95.0|-4.2|-3.4|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8: subjects were only included if their visit fell within the computed week (Day 49 to 63).|
1744453|NCT00407511|3207864|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.|
1744454|NCT00407511|3207864|Superiority or Other||Mean Difference (Final Values)|-4.6|Standard Error of the Mean|0.2|<|0.0001||95.0|-5.1|-4.1|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12: subjects were only included if their visit fell within the computed week (>= 78 days).|
1744455|NCT00407511|3207864|Superiority or Other||Mean Difference (Final Values)|-4.2|Standard Error of the Mean|0.2|<|0.0001||95.0|-4.7|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8, FAS. Week 8: subjects were only included if their visit fell within the computed week (49 to 63 days).|
1744456|NCT00407511|3207865|Superiority or Other||Mean Difference (Final Values)|-4.1|Standard Error of the Mean|0.2|<|0.0001||95.0|-4.5|-3.7|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 12|
1744457|NCT00407511|3207865|Superiority or Other||Mean Difference (Final Values)|-3.9|Standard Error of the Mean|0.2|<|0.0001||95.0|-4.3|-3.5|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 8|
1744458|NCT00407511|3207865|Superiority or Other||Mean Difference (Final Values)|-3.2|Standard Error of the Mean|0.2|<|0.0001||95.0|-3.6|-2.8|||Mixed Models Analysis||Parameter estimate: Mean Difference (Final Values) = least squares mean.|Week 4|
1744459|NCT00407511|3207866|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||End of treatment/last observation carried forward (EOT/LOCF): value consists of the mean of the last 7 post-baseline visits scores. Mean change: the arithmetic mean change and p-value from the single sample t-test. If < = 7 and > = 4 post-baseline scores were available, the mean pain score was computed using the available scores. The mean was not calculated if there were less than 4 post-baseline scores prior to study termination.|
1744460|NCT00407030|3207876|Superiority or Other||Mean Difference (Final Values)|1.3||||0.447|2-Sided|95.0|-2.1|4.6||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.|
1744461|NCT00407030|3207877|Superiority or Other||Mean Difference (Final Values)|-7.5|||<|0.001|2-Sided|95.0|-10.4|-4.6||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.|
1744462|NCT00407030|3207883|Superiority or Other||Mean Difference (Final Values)|-9.0|||<|0.001|2-Sided|95.0|-12.0|-5.9||Due to the hierarchical testing no adjustment of type I error was necessary.|ANCOVA|Independent variables in the model were treatment, baseline TWSTRS-Total score, gender, age, pre-treatment of cervical dystonia, and pooled center.||Hierarchical testing: Primary null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to placebo. Rejection of 1st hypothesis lead to test of 2nd null hypothesis: incobotulinumtoxinA (Xeomin) (120 Units) identical to placebo. Rejection of 2nd hypothesis lead to test of 3rd null hypothesis: incobotulinumtoxinA (Xeomin) (240 Units) identical to incobotulinumtoxinA (Xeomin) (120 Units). 3 separate models were used to test these hypotheses which results in different LS means estimates.|
1744463|NCT00406848|3207884|Superiority or Other|||||||0.242||||||p-value is for Trail Making Test Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744464|NCT00406848|3207884|Superiority or Other|||||||0.591||||||p-value is for Trail Making Test Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744465|NCT00406848|3207884|Superiority or Other|||||||0.858||||||p-value is for 2DCT Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744466|NCT00406848|3207884|Superiority or Other|||||||0.379||||||p-value is for 2DCT Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744467|NCT00406848|3207884|Superiority or Other|||||||0.141||||||p-value is for SDST Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744468|NCT00406848|3207884|Superiority or Other|||||||0.099||||||p-value is for SDST Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744469|NCT00406848|3207884|Superiority or Other|||||||0.158||||||p-value is for Delayed Recall Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744470|NCT00406848|3207884|Superiority or Other|||||||0.85||||||p-value is for Delayed Recall Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744471|NCT00406848|3207884|Superiority or Other|||||||0.19||||||p-value is for Learning Trials Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744472|NCT00406848|3207884|Superiority or Other|||||||0.922||||||p-value is for Learning Trials Score change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744473|NCT00406848|3207884|Superiority or Other|||||||0.3||||||p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744477|NCT00406848|3207886|Superiority or Other|||||||0.11||||||p-value is for QRS Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744478|NCT00406848|3207886|Superiority or Other|||||||0.065||||||p-value is for PR Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744479|NCT00406848|3207886|Superiority or Other|||||||0.376||||||p-value is for QTcB Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744480|NCT00406848|3207886|Superiority or Other|||||||0.721||||||p-value is for QTcF Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744481|NCT00406848|3207886|Superiority or Other|||||||0.815||||||p-value is for QT Interval change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change=Treatment+Pooled Investigator+Baseline|||
1744482|NCT00406848|3207887|Superiority or Other|||||||0.019|||||||Fisher Exact||||
1744483|NCT00406848|3207888|Superiority or Other|||||||0.036||||||p-value is for Fasting Glucose change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator|||
1744484|NCT00406848|3207888|Superiority or Other|||||||0.04||||||p-value is for Chloride change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator|||
1744485|NCT00406848|3207889|Superiority or Other|||||||0.048||||||p-value is for Mean Cell Hemoglobin Concentration change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator|||
1744486|NCT00406848|3207889|Superiority or Other|||||||0.019||||||p-value is for Hemoglobin change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator|||
1744487|NCT00406848|3207890|Superiority or Other|||||||0.014||||||p-value is for Erythrocyte Count change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator|||
1744488|NCT00406848|3207891|Superiority or Other||||||<|0.001||||||p-value is for Uric Acid change from baseline (Week 1) to Week 25.|ANOVA|Model: Change = Treatment + Pooled Investigator|||
1744489|NCT00406848|3207891|Superiority or Other||||||<|0.001||||||p-value is for Uric Acid change from baseline (Week 1) to Week 13.|ANOVA|Model: Change = Treatment + Pooled Investigator|||
1744490|NCT00406848|3207892|Superiority or Other||||||<|0.001||||||p-value is for Platelet Count change from baseline (Week 1) to Week 25.|ANOVA|Model: Change=Treatment+Pooled Investigator|||
1744491|NCT00406848|3207892|Superiority or Other||||||<|0.003||||||p-value is for Platelet Count change from baseline (Week 1) to Week 13.|ANOVA|Model: Change=Treatment+Pooled Investigator|||
1744492|NCT00406848|3207894|Superiority or Other|||||||0.201||||||p-value is for Orthostatic Hypotension|Fisher Exact||||
1744493|NCT00406848|3207894|Superiority or Other|||||||0.668||||||p-value is for Sustained Hypertension|Fisher Exact||||
1744494|NCT00406848|3207895|Superiority or Other|||||||0.813||||||p-value is for Weight Change (loss)|Fisher Exact||||
1744495|NCT00406848|3207895|Superiority or Other|||||||0.235||||||p-value is for Weight Change (gain)|Fisher Exact||||
1744496|NCT00406848|3207895|Superiority or Other|||||||0.107||||||p-value is for Systolic Blood Pressure|Fisher Exact||||
1744497|NCT00406848|3207895|Superiority or Other|||||||1||||||p-value is for Pulse.|Fisher Exact|||Pulse|
1744498|NCT00406848|3207895|Superiority or Other|||||||0.135||||||p-value is for Diastolic Blood Pressure.|Fisher Exact||||
1744499|NCT00406848|3207896|Superiority or Other|||||||0.127||||||p-value is for Weight change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744500|NCT00406848|3207896|Superiority or Other|||||||0.003||||||p-value is for Weight change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744501|NCT00406848|3207897|Superiority or Other|||||||0.038||||||p-value is for change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744502|NCT00406848|3207897|Superiority or Other|||||||0.121||||||p-value is for change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744503|NCT00406848|3207898|Superiority or Other|||||||0.193||||||p-value is for Diastolic BP change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744504|NCT00406848|3207898|Superiority or Other|||||||0.452||||||p-value is for Systolic BP change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744505|NCT00406848|3207898|Superiority or Other|||||||0.001||||||p-value is for Diastolic BP change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744506|NCT00406848|3207898|Superiority or Other|||||||0.637||||||p-value is for Systolic BP change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744507|NCT00406848|3207899|Superiority or Other|||||||0.036|||||||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model: Onset = Treatment + Visit + Baseline + Treatment*Visit.|||
1744508|NCT00406848|3207901|Superiority or Other|||||||0.31||||||p-value is for probability of response at Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment*Visit.|||
1744509|NCT00406848|3207901|Superiority or Other|||||||0.664||||||p-value is for probability of response at Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment*Visit.|||
1744653|NCT00406315|3208014|Superiority or Other||Mean|-1.6|||||2-Sided|95.0|-16.44|13.15||||||Triglycerides. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744510|NCT00406848|3207902|Superiority or Other|||||||0.817||||||p-values for Week 25 Remission - HAMD17 ≤ 10|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment*Visit.|||
1744511|NCT00406848|3207902|Superiority or Other|||||||0.864||||||p-values for Week 13 Remission - HAMD17 ≤ 10|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment*Visit.|||
1744512|NCT00406848|3207902|Superiority or Other|||||||0.694||||||p-values for Week 25 Remission HAMD17 ≤ 7|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment*Visit.|||
1744513|NCT00406848|3207902|Superiority or Other|||||||0.706||||||p-values for Week 13 remission (HAMD17 ≤ 7).|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment*Visit.|||
1744514|NCT00406848|3207903|Superiority or Other|||||||0.038||||||p-value is for change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline|||
1744515|NCT00406848|3207903|Superiority or Other|||||||0.255||||||p-value is for change from baseline (Week 1) to Week 13.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline|||
1744516|NCT00406848|3207904|Superiority or Other|||||||0.785||||||p-value is for change from baseline (Week 1) to Week 25.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline|||
1744517|NCT00406848|3207904|Superiority or Other|||||||0.555||||||p-value is for change from baseline (Week 1) to Week 9.|ANCOVA|Model: Change = Treatment + Pooled Investigator + Baseline|||
1744518|NCT00406848|3207905|Superiority or Other|||||||0.009||||||p-value is for change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744519|NCT00406848|3207905|Superiority or Other|||||||0.162||||||p-value is for change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744520|NCT00406848|3207906|Superiority or Other|||||||0.063||||||p-value is for PGI-I at Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment* Visit|||
1744521|NCT00406848|3207906|Superiority or Other|||||||0.214||||||p-value is for PGI-I at Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment* Visit|||
1744522|NCT00406848|3207907|Superiority or Other|||||||0.036||||||p-value is for Time in Pain While Awake Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744523|NCT00406848|3207907|Superiority or Other|||||||0.002||||||p-value is for Time in Pain While Awake Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744524|NCT00406848|3207907|Superiority or Other|||||||0.019||||||p-value is for Interference with Daily Activities Week 25 main effect of treatment.|Mixed Models Analysis|Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit|||
1744525|NCT00406848|3207907|Superiority or Other|||||||0.006||||||p-value is for Interference with Daily Activities Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744526|NCT00406848|3207907|Superiority or Other|||||||0.231||||||p-value is for Shoulder Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744527|NCT00406848|3207907|Superiority or Other|||||||0.124||||||p-value is for Shoulder Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744528|NCT00406848|3207907|Superiority or Other|||||||0.013||||||p-value is for Back Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744529|NCT00406848|3207907|Superiority or Other|||||||0.007||||||p-value is for Back Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744530|NCT00406848|3207907|Superiority or Other|||||||0.147||||||p-value is for Headaches Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744531|NCT00406848|3207907|Superiority or Other|||||||0.078||||||p-value is for Headaches Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744532|NCT00406848|3207907|Superiority or Other|||||||0.204||||||p-value is for Overall Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744533|NCT00406848|3207907|Superiority or Other|||||||0.005||||||p-value is for Overall Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744534|NCT00406848|3207908|Superiority or Other|||||||0.001||||||p-value is for Average Interference Score Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744535|NCT00406848|3207908|Superiority or Other||||||<|0.001||||||p-value is for Average Interference Score Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744536|NCT00406848|3207908|Superiority or Other||||||<|0.001||||||p-value is for Interference with Enjoyment of Life Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744537|NCT00406848|3207908|Superiority or Other||||||<|0.001||||||p-value is for Interference with Enjoyment of Life Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744538|NCT00406848|3207908|Superiority or Other||||||<|0.005||||||p-value is for Interference with Sleep Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744539|NCT00406848|3207908|Superiority or Other||||||<|0.015||||||p-value is for Interference with Sleep Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744540|NCT00406848|3207908|Superiority or Other||||||<|0.01||||||p-value is for Interference with Relations with Other People Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744541|NCT00406848|3207908|Superiority or Other||||||<|0.01||||||p-value is for Interference with Relations with Other People Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744542|NCT00406848|3207908|Superiority or Other||||||<|0.014||||||p-value is for Interference with Normal Work Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744543|NCT00406848|3207908|Superiority or Other||||||<|0.003||||||p-value is for Interference with Normal Work Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744544|NCT00406848|3207908|Superiority or Other||||||<|0.04||||||p-value is for Interference with Walking Ability Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744545|NCT00406848|3207908|Superiority or Other||||||<|0.019||||||p-value is for Interference with Walking Ability Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744546|NCT00406848|3207908|Superiority or Other||||||<|0.002||||||p-value is for Interference with Mood Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744547|NCT00406848|3207908|Superiority or Other||||||<|0.001||||||p-value is for Interference with Mood Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744548|NCT00406848|3207908|Superiority or Other||||||<|0.06||||||p-value is for Interference with General Activity Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744549|NCT00406848|3207908|Superiority or Other||||||<|0.011||||||p-value is for Interference with General Activity Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744550|NCT00406848|3207908|Superiority or Other||||||<|0.058||||||p-value is for Severity of Pain Right Now Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744551|NCT00406848|3207908|Superiority or Other||||||<|0.016||||||p-value is for Severity of Pain Right Now Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744552|NCT00406848|3207908|Superiority or Other||||||<|0.013||||||p-value is for Severity of Average Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744553|NCT00406848|3207908|Superiority or Other||||||<|0.001||||||p-value is for Severity of Average Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744554|NCT00406848|3207908|Superiority or Other||||||<|0.126||||||p-value is for Severity of Least Pain Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744555|NCT00406848|3207908|Superiority or Other||||||<|0.009||||||p-value is for Severity of Least Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744556|NCT00406848|3207908|Superiority or Other||||||<|0.1||||||p-value is for Severity of Worst Pain - Week 25 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744557|NCT00406848|3207908|Superiority or Other||||||<|0.034||||||p-value is for Severity of Worst Pain Week 13 main effect of treatment.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744558|NCT00406848|3207909|Superiority or Other|||||||0.123||||||p-value is for Retardation subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744559|NCT00406848|3207909|Superiority or Other|||||||0.934||||||p-value is for Retardation subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744560|NCT00406848|3207909|Superiority or Other|||||||0.93||||||p-value is for Sleep subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744561|NCT00406848|3207909|Superiority or Other|||||||0.984||||||p-value is for Sleep subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744562|NCT00406848|3207909|Superiority or Other|||||||0.296||||||p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744563|NCT00406848|3207909|Superiority or Other|||||||0.749||||||p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744564|NCT00406848|3207909|Superiority or Other|||||||0.027||||||p-value is for Core Mood subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744565|NCT00406848|3207909|Superiority or Other|||||||0.529||||||p-value is for Core Mood subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744566|NCT00406848|3207909|Superiority or Other|||||||0.048||||||p-value is for HAMD-17 Bech subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744567|NCT00406848|3207909|Superiority or Other|||||||0.488||||||p-value is for Bech subscale change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744568|NCT00406848|3207909|Superiority or Other|||||||0.059||||||p-value is for Maier subscale change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744569|NCT00406848|3207909|Superiority or Other|||||||0.084||||||p-value is for HAMD-17 total score change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744570|NCT00406848|3207909|Superiority or Other|||||||0.773||||||p-value is for HAMD-17 total score change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744571|NCT00406848|3207910|Superiority or Other|||||||0.004||||||p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 25.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744572|NCT00406848|3207910|Superiority or Other|||||||0.115||||||p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 13.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.|||
1744573|NCT00406848|3207911|Superiority or Other|||||||0.397||||||The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment* Visit + Baseline + Baseline*Visit.||Tested was the null hypothesis that there would be no difference in changes from baseline (Week 1) to Week 13 on the HAMD-17 Maier subscale between duloxetine and placebo treatment groups.|
1744574|NCT00406783|3207914|Superiority or Other||||||<|0.001|||||||ANOVA||||
1744575|NCT00406783|3207915|Superiority or Other||||||<|0.001|||||||ANOVA||||
1744576|NCT00406692|3207919|Superiority or Other||Mean Difference (Final Values)|1.5|Standard Error of the Mean|4.0|<|0.55|2-Sided|95.0|||||Mixed Models Analysis|||Null Hypothesis: No significant difference for mean scores obtained for baseline, week 4 and week 12.|
1744577|NCT00406692|3207920|Superiority or Other||Mean Difference (Net)|-6.7|Standard Error of the Mean|3.9|<|0.22|2-Sided|95.0|||||Mixed Models Analysis|||Null Hypothesis: No significant change in the mean number of words produced during phonetic portion of the Controlled Word Association Test between the baseline period and the treatment weeks.|
1744578|NCT00406692|3207921|Superiority or Other||Mean Difference (Final Values)|-6.7|Standard Error of the Mean|1.5|<|0.0003|2-Sided|95.0||||Null Hypothesis: No difference in the mean daily standard drinks consumed for the baseline period and the zonisamide treatment weeks|Mixed Models Analysis|||Null Hypothesis: No difference in the mean daily standard drinks consumed between the baseline period and the zonisamide treatment weeks.|
1744579|NCT00406653|3207939|Superiority or Other|||||||0.112||||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.|
1744580|NCT00406653|3207946|Superiority or Other|||||||0.436||||||All statistical testing was performed at a pre-specified alpha-level of 5%.|Cochran-Armitage Trend Test|||The Cochran-Armitage trend test was performed to evaluate whether a relationship existed between the response and dose regimen by comparing the proportion of participants in response across all four treatment arms. Normal approximation was used if the number of responses in a treatment group is at least 5. Otherwise an exact method was used.|
1745247|NCT00402987|3208368|Superiority or Other|||||||0.557|||||||Regression, Logistic|Treatment as a factor|||
1744581|NCT00406653|3207947|Superiority or Other||Risk Ratio (RR)|1.18|||||2-Sided|95.0|0.4|3.44|||||All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.|Conditional on abatacept (ABA) 30/~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA ~10 mg/kg vs PLA to be tested at 5% signficance level. Null hypothesis=no treatment difference (relative risk [RR] of ABA over placebo=1).First comparison: power=95%,sample size=134,expected PLA response rate=15%, ABA 30/~10 mg/kg=35%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata|
1744582|NCT00406653|3207950|Superiority or Other||Risk Ratio (RR)|1.2||||0.611|2-Sided|95.0|0.6|2.4||Due to randomization misspecification, 2:2:2:1 ratio applied instead of planned 2:1:2:2 (placebo, ABA 3mg/kg, ~10mg/kg, 30/~10mg/kg). Only ~half intended number assigned to ABA 30/~10 mg/kg arm and ~double intended number assigned to ABA 3 mg/kg arm|Cochran-Mantel-Haenszel|Second primary comparison (conditional on first): power=91%, sample size=134, 5% significance; expected PLA response rate= 25%, ABA/~10 mg/kg=45%|All participants who prematurely discontinued for any reason considered not to have achieved clinical response. Normal approximation used if number of responses in treatment group was ≥5. Otherwise an exact method was used.|Conditional on abatacept (ABA) 30/~10 mg/kg vs placebo (PLA)comparison being statistically significant at 5% significance level, ABA ~10 mg/kg vs PLA to be tested at 5% significance level. Null hypothesis=no treatment difference (relative risk [RR] of ABA over placebo=1).First comparison: power=99%,sample size=134,expected PLA response rate=25%, ABA 30/~10 mg/kg=55%. Cochran-Mantel-Haenszel Chi square p-value and RR along with 95% confidence interval provided, adjusting for randomization strata|
1744583|NCT00406640|3207951|Superiority or Other|||||||0.653|||||||t-test, 2 sided|||DVS SR vs. ESC: after > 2 weeks of taper|
1744584|NCT00406640|3207951|Superiority or Other|||||||0.025|||||||t-test, 2 sided|||DVS SR vs. ESC: after 2 weeks of taper|
1744585|NCT00406640|3207951|Superiority or Other|||||||0.055|||||||t-test, 2 sided|||DVS SR vs. ESC: after 1 week of taper|
1744586|NCT00406640|3207951|Superiority or Other|||||||0.927|||||||t-test, 2 sided|||DVS SR vs. ESC: end of therapy|
1744587|NCT00406640|3207955|Superiority or Other||Odds Ratio (OR)|1.34||||0.234||95.0|0.83|2.16|||Chi-squared||Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.|
1744588|NCT00406640|3207956|Superiority or Other||Odds Ratio (OR)|1.12||||0.702||95.0|0.63|2.0|||Chi-squared||Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.|
1744589|NCT00406640|3207957|Superiority or Other||Mean Difference (Net)|0.01||||0.635||95.0|-0.03|0.06|||Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) with treatment, time and site as factors and baseline as covariant.|DVS SR adjusted mean change minus ESC adjusted mean change|DVS SR compared to ESC|
1744590|NCT00406640|3207958|Superiority or Other||Mean Difference (Net)|0.37||||0.516||95.0|-0.75|1.49|||Mixed Models Analysis|Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.|DVS SR adjusted mean change minus ESC adjusted mean change.|DVS SR compared to ESC|
1744591|NCT00406640|3207959|Superiority or Other||Mean Difference (Final Values)|0.14||||0.239||95.0|-0.09|0.37|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR minus ESC adjusted mean||
1744592|NCT00406640|3207960|Superiority or Other||Mean Difference (Final Values)|0.12||||0.26||95.0|-0.09|0.33|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR minus ESC adjusted mean|DVS SR compared with ESC|
1744593|NCT00406640|3207961|Superiority or Other||Odds Ratio (OR)|0.571||||0.0054||95.0|0.39|0.85|||Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariant.|Estimated odds ratio of DVS SR to ESC. Odds ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.|
1744594|NCT00406640|3207962|Superiority or Other||Odds Ratio (OR)|0.608||||0.077||95.0|0.4|0.92|||Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariant.|Estimated odds ratio of DVS SR to ESC. Odd ratio adjusted for baseline, treatment and site.|DVS SR compared with ESC.|
1744595|NCT00406640|3207963|Superiority or Other||Mean Difference (Final Values)|0.67||||0.243||95.0|-0.46|1.81|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) with baseline score as a covariant and factors for center, week and treatment.|DVS SR adjusted mean change minus ESC adjusted mean change.|DVS SR compared with ESC|
1744596|NCT00406367|3207979|Superiority or Other||Mean Difference (Final Values)|-1.0|||<|0.001|2-Sided|95.0|-1.4|-0.5||No type I-error adjustment was necessary in this study.|ANCOVA|Indepent variables in the model were treatment, baseline JRS-Severity score, gender, age, dose, and pooled center.||The null hypothesis in the analysis of covariance (ANCOVA) model was the absence of difference in the change from baseline in the JRS severity subscore between incobotulinumtoxinA (Xeomin) and placebo. The ANCOVA model was performed 2-sided (type-I error=5 percent) and change from baseline in the JRS Severity subscore assessed by a blinded Independent Rater as dependent variable. The independent variables were treatment, baseline JRS Severity subscore, gender, age, dose group, and pooled center.|
1744597|NCT00406354|3207980|Superiority or Other|||||||0.101||||||p-value is from comparison of atomoxetine fast group versus atomoxetine slow group for any clinically relevant categories of adverse events during the nine-week study treatment period.|Fisher Exact||||
1744598|NCT00406354|3207981|Superiority or Other|||||||0.102||||||p-value is from comparison of atomoxetine fast group versus atomoxetine slow group for any clinically relevant categories of adverse events during the initial three weeks of study treatment|Fisher Exact||||
1744599|NCT00406354|3207982|Superiority or Other||Hazard Ratio (HR)|2.193||||0.016||95.0|1.16|4.146||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Log Rank||||
1744600|NCT00406354|3207983|Superiority or Other||Mean Difference (Final Values)|4.9|Standard Error of the Mean|3.3||0.138|2-Sided|95.0|-1.6|11.5||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.||
1744654|NCT00406315|3208014|Superiority or Other||Mean|-2.5|||||2-Sided|95.0|-7.07|2.09||||||LDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744601|NCT00406354|3207984|Superiority or Other||Mean Difference (Final Values)|8.0|Standard Error of the Mean|3.4||0.018|2-Sided|95.0|1.4|14.7||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive results are in favor of the atomoxetine arms.||
1744602|NCT00406354|3207985|Superiority or Other||Mean Difference (Final Values)|8.1|Standard Error of the Mean|3.3||0.015|2-Sided|95.0|1.6|14.6||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.||
1744603|NCT00406354|3207986|Superiority or Other||Mean Difference (Final Values)|10.7|Standard Error of the Mean|2.9|<|0.001|2-Sided|95.0|4.9|16.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.||
1744604|NCT00406354|3207987|Superiority or Other||Mean Difference (Final Values)|5.5|Standard Error of the Mean|2.8||0.05|2-Sided|95.0|0.0|10.9||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.||
1744605|NCT00406354|3207988|Superiority or Other||Mean Difference (Final Values)|-7.6|Standard Error of the Mean|3.1||0.017|2-Sided|95.0|-13.8|-1.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.||
1744606|NCT00406354|3207989|Superiority or Other||Mean Difference (Final Values)|5.0|Standard Error of the Mean|2.2||0.021|2-Sided|95.0|0.8|9.3||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Positive values are in favor of the atomoxetine arms.||
1744607|NCT00406354|3207990|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.||
1744608|NCT00406354|3207991|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.||
1744609|NCT00406354|3207992|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.2|<|0.001|2-Sided|95.0|-1.1|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.||
1744610|NCT00406354|3207993|Superiority or Other||Mean Difference (Final Values)|-1.4|Standard Error of the Mean|1.7||0.406|2-Sided|95.0|-4.9|2.0||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|ANCOVA||Negative values are in favor of the atomoxetine arms.||
1744611|NCT00406354|3207994|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|0.7||0.01|2-Sided|95.0|-3.2|-0.4||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.||
1744612|NCT00406354|3207995|Superiority or Other||Mean Difference (Final Values)|-3.5|Standard Error of the Mean|1.4||0.01|2-Sided|95.0|-6.2|-0.9||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.||
1744613|NCT00406354|3207996|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.1||0.006|2-Sided|95.0|-0.4|-0.1||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.||
1744614|NCT00406354|3207997|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.1|<|0.001|2-Sided|95.0|-0.6|-0.2||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.||
1744615|NCT00406354|3207998|Superiority or Other||Mean Difference (Final Values)|-3.9|Standard Error of the Mean|1.0|<|0.001|2-Sided|95.0|-5.8|-2.0||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.||
1744616|NCT00406354|3207999|Superiority or Other||Mean Difference (Final Values)|-3.5|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-5.3|-1.8||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.||
1744617|NCT00406354|3208000|Superiority or Other||Mean Difference (Final Values)|-7.4|Standard Error of the Mean|1.8|<|0.001|2-Sided|95.0|-11.0|-3.8||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9.|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.||
1744618|NCT00406354|3208001|Superiority or Other||Mean Difference (Final Values)|-3.2|Standard Error of the Mean|0.9|<|0.001|2-Sided|95.0|-5.0|-1.5||p-value is from comparison of combined atomoxetine fast group plus atomoxetine slow group versus placebo group at Week 9|Mixed Models Analysis||Negative values are in favor of the atomoxetine arms.||
1744619|NCT00406315|3208002|Superiority or Other||Mean|15.32|||||2-Sided|95.0|9.97|20.68||||||Global Satisfaction, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744620|NCT00406315|3208002|Superiority or Other||Mean|15.32|||||2-Sided|95.0|9.97|20.68||||||Global Satisfaction, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744621|NCT00406315|3208002|Superiority or Other||Mean|6.45|||||2-Sided|95.0|2.98|9.93||||||Convenience, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744622|NCT00406315|3208002|Superiority or Other||Mean|6.45|||||2-Sided|95.0|2.98|9.93||||||Convenience, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744680|NCT00406133|3208033|Superiority or Other|||||||0.98||||||P-value for the 15-24 year old age group|Regression, Logistic||||
1744623|NCT00406315|3208002|Superiority or Other||Mean|18.49|||||2-Sided|95.0|11.94|25.04||||||Side Effect, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744624|NCT00406315|3208002|Superiority or Other||Mean|18.49|||||2-Sided|95.0|11.94|25.04||||||Side Effect, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744625|NCT00406315|3208002|Superiority or Other||Mean|10.49|||||2-Sided|95.0|5.95|15.02||||||Effectiveness, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744626|NCT00406315|3208002|Superiority or Other||Mean|10.49|||||2-Sided|95.0|5.95|15.02||||||Effectiveness, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744627|NCT00406315|3208003|Superiority or Other||Mean|5.27|||||2-Sided|95.0|3.89|6.65||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744628|NCT00406315|3208003|Superiority or Other||Mean|7.88|||||2-Sided|95.0|6.07|9.69||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744629|NCT00406315|3208004|Superiority or Other||Mean|-0.88|||||2-Sided|95.0|-1.13|-0.63||||||Global Rating, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744630|NCT00406315|3208004|Superiority or Other||Mean|-1.02|||||2-Sided|95.0|-1.31|-0.73||||||Global Rating, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744631|NCT00406315|3208004|Superiority or Other||Mean|-4.21|||||2-Sided|95.0|-5.57|-2.85||||||Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744632|NCT00406315|3208004|Superiority or Other||Mean|-4.61|||||2-Sided|95.0|-5.95|-3.26||||||Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744633|NCT00406315|3208005|Superiority or Other||Mean|-1.58|||||2-Sided|95.0|-2.16|-0.99||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744634|NCT00406315|3208005|Superiority or Other||Mean|-2.55|||||2-Sided|95.0|-3.27|-1.83||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744635|NCT00406315|3208006|Superiority or Other||Mean|3.2|||||2-Sided|95.0|3.02|3.34||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744636|NCT00406315|3208006|Superiority or Other||Mean|2.7|||||2-Sided|95.0|2.52|2.88||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744637|NCT00406315|3208007|Superiority or Other||Mean|-0.47|||||2-Sided|95.0|-0.58|-0.36||||||Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744638|NCT00406315|3208007|Superiority or Other||Mean|-0.76|||||2-Sided|95.0|-0.9|-0.61||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744639|NCT00406315|3208008|Superiority or Other||Mean|-0.92|||||2-Sided|95.0|-1.48|-0.35||||||Negative Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744640|NCT00406315|3208008|Superiority or Other||Mean|-1.67|||||2-Sided|95.0|-2.36|-0.99||||||Negative Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744641|NCT00406315|3208008|Superiority or Other||Mean|-2.43|||||2-Sided|95.0|-3.03|-1.83||||||Positive Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744642|NCT00406315|3208008|Superiority or Other||Mean|-3.3|||||2-Sided|95.0|-4.07|-2.53||||||Positive Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744643|NCT00406315|3208008|Superiority or Other||Mean|-6.61|||||2-Sided|95.0|-8.59|-4.63||||||Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744644|NCT00406315|3208008|Superiority or Other||Mean|-10.22|||||2-Sided|95.0|-12.7|-7.75||||||Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744645|NCT00406315|3208009|Superiority or Other||Mean|0.01|||||2-Sided|95.0|-0.06|0.07||||||Global Incapacitation Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744646|NCT00406315|3208009|Superiority or Other||Mean|0.03|||||2-Sided|95.0|-0.05|0.11||||||Global Severity Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744647|NCT00406315|3208009|Superiority or Other||Mean|0.05|||||2-Sided|95.0|-0.32|0.42||||||Total Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744648|NCT00406315|3208010|Superiority or Other||Mean|-3.0|||||2-Sided|95.0|-6.2|0.1||||||Hip. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744649|NCT00406315|3208010|Superiority or Other||Mean|-2.9|||||2-Sided|95.0|-5.93|0.11||||||Waist. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744650|NCT00406315|3208011|Superiority or Other||Mean|134.8|||||2-Sided|95.0|-20.43|289.98||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744651|NCT00406315|3208012|Superiority or Other||Mean|3.0|||||2-Sided|95.0|-0.09|6.15||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744652|NCT00406315|3208013|Superiority or Other||Mean|0.1|||||2-Sided|95.0|-0.02|0.14||||||The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1745162|NCT00403546|3208316|Superiority||Mean Difference (Final Values)|-0.18||||0.737|2-Sided|95.0|-1.23|0.88|||Mixed Models Analysis|||At Baseline|
1744655|NCT00406315|3208014|Superiority or Other||Mean|-0.2|||||2-Sided|95.0|-1.82|1.44||||||HDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744656|NCT00406315|3208015|Superiority or Other||Mean|-3.0|||||2-Sided|95.0|-8.48|2.41||||||Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.|
1744657|NCT00406315|3208016|Superiority or Other||One-sided upper confidence limit|-0.33|||||1-Sided|95.0|||||||A one-sided 95% CI was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.|Week 16 LOCF. Based on past information, the standard deviation of the mean weight difference was expected to be 2.2. The sample size of the study was estimated so that the one-sided CI of the mean weight decrease has a certain width. To obtain a one-sided CI with a width of 0.27 kg, a sample size of 180 subjects was needed. In other words, we were 95% certain that the true mean weight decrease was in an interval starting from the observed weight decrease and extending 0.27 kg unit above it.|
1744658|NCT00406315|3208016|Superiority or Other||One-sided upper confidence limit|-0.53|||||1-Sided|95.0|||||||A one-sided 95% confidence interval (CI) was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.|Week 16.|
1744659|NCT00406133|3208021|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by >=0.3% and 26-week value <7.0%) evaluated similarly using logistic regression models.|
1744660|NCT00406133|3208022|Superiority or Other|||||||0.002|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by >=0.3% and 26-week value <7.0%) evaluated similarly using logistic regression models.|
1744661|NCT00406133|3208023|Superiority or Other||||||<|0.001|||||||Regression, Logistic|||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center) and 26-week binary A1c outcomes (decrease and increase in A1C from baseline by >=0.3% and 26-week value <7.0%) evaluated similarly using logistic regression models.|
1744662|NCT00406133|3208024|Superiority or Other|||||||0.006||||||P-value for the >=25 year old age group|Regression, Logistic||||
1744663|NCT00406133|3208024|Superiority or Other|||||||0.67||||||P-value for the 15-24 year old age group|Regression, Logistic||||
1744664|NCT00406133|3208024|Superiority or Other|||||||0.02||||||P-value for the 8-14 year age group|Regression, Logistic|||A post-hoc defined binary outcome of 26-week glycated hemoglobin <7.0% with no severe hypoglycemic events was analyzed in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.|
1744665|NCT00406133|3208025|Superiority or Other|||||||0.005||||||P-value for >=25 year age group|Regression, Logistic||||
1744666|NCT00406133|3208025|Superiority or Other|||||||0.8||||||P-value for 14-24 year age group|Regression, Logistic||||
1744667|NCT00406133|3208025|Superiority or Other|||||||0.01||||||P-value for 8-14 year age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.|
1744668|NCT00406133|3208026|Superiority or Other|||||||0.02||||||P-value for >=25 year old age group.|Regression, Logistic||||
1744669|NCT00406133|3208026|Superiority or Other|||||||0.84||||||P-value for 15-24 year old age group.|Regression, Logistic||||
1744670|NCT00406133|3208026|Superiority or Other|||||||0.18||||||P-value for 8-14 year age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.|
1744671|NCT00406133|3208027|Superiority or Other||||||<|0.001||||||P-value for the >=25 year old age group|Regression, Logistic||||
1744672|NCT00406133|3208027|Superiority or Other||||||<|0.57||||||P-value for 15-24 year old age group|Regression, Logistic||||
1744673|NCT00406133|3208027|Superiority or Other||||||<|0.009||||||P-value for the 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.|
1744674|NCT00406133|3208028|Superiority or Other||Ratio of treatment differences|408148.0|||||2-Sided|95.0|-176644.0|3475108.0||||||"ICER = Incremental Cost Effectiveness Ratio is defined as the mean difference in costs between the treatment groups divided by the mean difference in QALY (quality-adjusted life-year) between the treatment groups:~(mean cost[CGM] - mean cost [control]) / (mean QALY[CGM] - mean QALY[SMBG]).~Units are dollars per QALY."|
1744675|NCT00406133|3208029|Superiority or Other|||||||0.04||||||Nominal p-value not adjusted for multiple comparisons|ANCOVA||||
1744676|NCT00406133|3208030|Superiority or Other|||||||0.39||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Glucose variability was assessed by computing the absolute rate of change.|
1744677|NCT00406133|3208031|Superiority or Other|||||||0.05||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.|
1744678|NCT00406133|3208032|Superiority or Other|||||||0.005||||||P-value representative of 13 and 26 weeks combined|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.|
1744679|NCT00406133|3208033|Superiority or Other|||||||0.48||||||P-value for the >=25 year old age group|Regression, Logistic||||
1744681|NCT00406133|3208033|Superiority or Other|||||||0.24||||||P-value for 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.|
1744682|NCT00406133|3208034|Superiority or Other|||||||0.003||||||P-value for the >=25 year age group|Regression, Logistic||||
1744683|NCT00406133|3208034|Superiority or Other|||||||0.46||||||P-value for the 15-24 year age group|Regression, Logistic||||
1744684|NCT00406133|3208034|Superiority or Other|||||||0.04||||||P-value for the 8-14 year old age group|Regression, Logistic|||Within each age group, in addition to the primary ANCOVA analysis, pre-specified 26-week binary glycated hemoglobin outcomes (relative decrease by >=10%, 26-week level <7.0%, absolute decrease by >=0.5%, relative increase by >=10%, absolute increase by >=0.5%) were evaluated in logistic regression models, adjusted for baseline glycated hemoglobin level and clinical center.|
1744685|NCT00406133|3208035|Superiority or Other|||||||0.03||||||P-value representative of 13 and 26 weeks combined.|ANCOVA|||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.|
1744686|NCT00406133|3208036|Superiority or Other||||||<|0.001||||||Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.|ANCOVA|Adjusted for baseline value, clinical center and type of continuous glucose monitor.||Percentages of values less than or greater than a given threshold were converted to minutes per day by multiplying by 1,440. A nonparametric approach was followed using an ANCOVA based on ranks of the 26 week values, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.|
1744687|NCT00406133|3208037|Superiority or Other||||||<|0.001|||||||ANCOVA|Adjusted for baseline A1c and clinical center.||Other preplanned secondary outcomes included change in A1c from baseline to 26 weeks in an ANCOVA model (adjusted for baseline A1c and clinical center).|
1744688|NCT00406133|3208038|Superiority or Other|||||||0.07||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.|||
1744689|NCT00406133|3208038|Superiority or Other|||||||0.48||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.|||
1744690|NCT00406133|3208038|Superiority or Other|||||||0.66||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Glucose variability was assessed by computing the absolute rate of change.|
1744691|NCT00406133|3208039|Superiority or Other|||||||0.1||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.|||
1744692|NCT00406133|3208039|Superiority or Other|||||||0.99||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.|||
1744693|NCT00406133|3208039|Superiority or Other|||||||0.5||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).|
1744694|NCT00406133|3208040|Superiority or Other|||||||0.41||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.|||
1744695|NCT00406133|3208040|Superiority or Other|||||||0.79||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.|||
1744696|NCT00406133|3208040|Superiority or Other|||||||0.29||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).|
1744697|NCT00406133|3208041|Superiority or Other||||||<|0.001||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.|||
1744698|NCT00406133|3208041|Superiority or Other||||||<|0.44||||||P-value for the comparison of treatment groups at 26wks adjusting for the baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.|||
1744740|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.3||||0.355|2-Sided|95.0|-0.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745163|NCT00403546|3208317|Superiority||Mean Difference (Net)|-0.12||||0.84|2-Sided|95.0|-1.32|1.08|||Mixed Models Analysis|||At Week 8|
1744699|NCT00406133|3208041|Superiority or Other||||||<|0.18||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).|
1744700|NCT00406133|3208042|Superiority or Other|||||||0.002||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.|||
1744701|NCT00406133|3208042|Superiority or Other|||||||0.85||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.|||
1744702|NCT00406133|3208042|Superiority or Other|||||||0.58||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).|
1744703|NCT00406133|3208043|Superiority or Other||||||<|0.001||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for >=25 years age group.|ANCOVA||||
1744704|NCT00406133|3208043|Superiority or Other||||||<|0.79||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 15-24 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.|||
1744705|NCT00406133|3208043|Superiority or Other||||||<|0.53||||||P-value for the comparison of treatment groups at 26wks adjusting for baseline for 8-14 years age group.|ANCOVA|Adjusted for the corresponding baseline value, baseline glycated hemoglobin level, clinical center, and type of continuous glucose monitor.||Continuous glucose monitoring data in both groups following the 26-week visit (blinded use in the control group and unblinded use in the continuous glucose monitoring group) were used to estimate the amount of time per day the glucose level was hypoglycemic (<=70 mg/dL and <=50 mg/dL), hyperglycemic (>180 mg/dL and >250 mg/dL), and in the target range (71 to 180 mg/dL).|
1744706|NCT00406133|3208044|Superiority or Other|||||||1||||||P-value is for N(%) of subjects with >=1 severe hypo event with seizure or comma in the >=25 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher’s exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.|
1744707|NCT00406133|3208044|Superiority or Other|||||||0.48||||||P-value is for N(%) of subjects with >=1 severe hypo event with seizure or comma in the 15-24 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher’s exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.|
1744708|NCT00406133|3208044|Superiority or Other|||||||0.74||||||P-value is for N(%) of subjects with >=1 severe hypo event with seizure or comma in the 8-14 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher’s exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.|
1744709|NCT00406133|3208044|Superiority or Other|||||||1||||||P-value is for N(%) of subjects with >=1 severe hypo event in the >=25 year age group.|Fisher Exact||||
1744710|NCT00406133|3208044|Superiority or Other|||||||0.48||||||P-value is for N(%) of subjects with >=1 severe hypo event in the 15-24 year age group.|Fisher Exact||||
1744711|NCT00406133|3208044|Superiority or Other|||||||0.74||||||P-value is for N(%) of subjects with >=1 severe hypo event in the 8-14 year age group.|Fisher Exact|||The proportions of patients experiencing one or more severe hypoglycemic events in each treatment group were compared using Fisher’s exact test. Incidences of hypoglycemic events were compared and confidence intervals for the treatment group difference calculated using permutation tests. Similar analyses were performed for the subset of hypoglycemic events associated with seizure or coma.|
1744712|NCT00406133|3208045|Superiority or Other|||||||0.16||||||P-value was for the comparison of RT-CGM group and Control group.|ANCOVA|Based on the ranks of the 26wk values using VDW scores, adjusted for the baseline value, clinical center, and type of continuous glucose monitor.||A sample size of 120 subjects was planned to have 90% power to detect a difference in this outcome between treatment groups, assuming a population difference of 29 min/day, standard deviation of the 26-week values of 59 min/day, correlation between baseline and 26-week values of 0.66, an α=0.05, and no more than 15% losses to follow-up.|
1744713|NCT00406133|3208046|Superiority or Other||||||<|0.001||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value is for age >=25 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.|||
1744714|NCT00406133|3208046|Superiority or Other||||||<|0.52||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value for age 15-24 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.|||
1744741|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.4||||0.288|2-Sided|95.0|-0.3|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744715|NCT00406133|3208046|Superiority or Other||||||<|0.29||||||"A P value of 0.0167 was considered the significance level for the primary analysis in each age group to maintain an overall type I error rate of 0.05.~P value is for age 8-14 group."|ANCOVA|Performed in each age group and adjusted for the baseline A1c and clinical center.||The study was to test whether the use of CGM will lower A1c at 26 weeks. The estimated sample size was 110 for each age group, which will provide 90% power to detect a difference between treatment groups in each of the age groups assuming a population difference of 0.5%, a two-tailed test with type I error rate of 5%, standard deviation of the 6 month HbA1c values of 0.9, correlation between baseline and 26-week values of 0.58.|
1744716|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.2||||0.592|2-Sided|95.0|-0.6|1.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744717|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.1||||0.853|2-Sided|95.0|-0.8|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744718|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.5||||0.233|2-Sided|95.0|-0.3|1.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744719|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.1||||0.825|2-Sided|95.0|-0.8|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744720|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.2||||0.644|2-Sided|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744721|NCT00406029|3208052|Superiority or Other||Difference in LS Means|-0.3||||0.579|2-Sided|95.0|-1.2|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744722|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.9||||0.062|2-Sided|95.0|0.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744723|NCT00406029|3208052|Superiority or Other||Difference in LS Means|-0.2||||0.688|2-Sided|95.0|-1.2|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744724|NCT00406029|3208052|Superiority or Other||Difference in LS Means|-0.3||||0.465|2-Sided|95.0|-1.2|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744725|NCT00406029|3208052|Superiority or Other||Difference in LS Means|-0.4||||0.334|2-Sided|95.0|-1.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744726|NCT00406029|3208052|Superiority or Other||Difference in LS Means|-0.1||||0.768|2-Sided|95.0|-1.0|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744727|NCT00406029|3208052|Superiority or Other||Difference in LS Means|-0.5||||0.283|2-Sided|95.0|-1.4|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744728|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.7||||0.157|2-Sided|95.0|-0.3|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744729|NCT00406029|3208052|Superiority or Other||Difference in LS Means|-0.2||||0.663|2-Sided|95.0|-1.1|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744730|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.0||||0.947|2-Sided|95.0|-0.9|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744731|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.1||||0.883|2-Sided|95.0|-0.9|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744732|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.5||||0.212|2-Sided|95.0|-0.3|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744733|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.4||||0.285|2-Sided|95.0|-0.4|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744734|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.3||||0.48|2-Sided|95.0|-0.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744735|NCT00406029|3208052|Superiority or Other||Difference in LS Means|-0.1||||0.896|2-Sided|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744736|NCT00406029|3208052|Superiority or Other||Difference in LS Means|-0.1||||0.749|2-Sided|95.0|-0.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744737|NCT00406029|3208052|Superiority or Other||Difference in LS Means|-0.1||||0.792|2-Sided|95.0|-0.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744738|NCT00406029|3208052|Superiority or Other||Difference in LS Means|-0.5||||0.198|2-Sided|95.0|-1.2|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744739|NCT00406029|3208052|Superiority or Other||Difference in LS Means|-0.1||||0.831|2-Sided|94.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744742|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.3||||0.38|2-Sided|95.0|-0.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744743|NCT00406029|3208052|Superiority or Other||Difference in LS Means|0.5||||0.154|2-Sided|95.0|-0.2|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744744|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-3.2||||0.083|2-Sided|95.0|-6.8|0.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744745|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-2.8||||0.143|2-Sided|95.0|-6.6|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744746|NCT00406029|3208053|Superiority or Other||Difference in LS Means|0.3||||0.891|2-Sided|95.0|-3.5|4.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744747|NCT00406029|3208053|Superiority or Other||Difference in LS Means|0.1||||0.972|2-Sided|95.0|-3.6|3.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744748|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-2.3||||0.254|2-Sided|95.0|-6.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744749|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-2.8||||0.172|2-Sided|95.0|-6.8|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744750|NCT00406029|3208053|Superiority or Other||Difference in LS Means|1.4||||0.477|2-Sided|95.0|-2.5|5.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744751|NCT00406029|3208053|Superiority or Other||Difference in LS Means|1.8||||0.399|2-Sided|95.0|-2.4|6.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744752|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-2.2||||0.256|2-Sided|95.0|-6.0|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744753|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-1.8||||0.341|2-Sided|95.0|-5.6|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744754|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-1.0||||0.618|2-Sided|95.0|-4.7|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744755|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-0.2||||0.931|2-Sided|95.0|-4.1|3.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744756|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-1.2||||0.541|2-Sided|95.0|-5.2|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744757|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-0.1||||0.975|2-Sided|95.0|-4.0|3.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744758|NCT00406029|3208053|Superiority or Other||Difference in LS Means|3.9||||0.052|2-Sided|95.0|0.0|7.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744759|NCT00406029|3208053|Superiority or Other||Difference in LS Means|3.7||||0.075|2-Sided|95.0|-0.4|7.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744760|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-4.0||||0.042|2-Sided|95.0|-7.8|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744761|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-1.5||||0.424|2-Sided|95.0|-5.1|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744762|NCT00406029|3208053|Superiority or Other||Difference in LS Means|0.1||||0.944|2-Sided|95.0|-3.5|3.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744763|NCT00406029|3208053|Superiority or Other||Difference in LS Means|0.0||||0.994|2-Sided|95.0|-3.7|3.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744764|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-3.1||||0.094|2-Sided|95.0|-6.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744765|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-1.2||||0.533|2-Sided|95.0|-4.8|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744766|NCT00406029|3208053|Superiority or Other||Difference in LS Means|1.3||||0.467|2-Sided|95.0|-2.3|5.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744767|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-0.4||||0.846|2-Sided|94.0|-4.1|3.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744768|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-2.6||||0.134|2-Sided|95.0|-6.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744769|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-0.9||||0.599|2-Sided|95.0|-4.4|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744770|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-0.4||||0.84|2-Sided|95.0|-3.8|3.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744771|NCT00406029|3208053|Superiority or Other||Difference in LS Means|-0.2||||0.924|2-Sided|95.0|-3.5|3.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744772|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-3.2||||0.088|2-Sided|95.0|-6.9|0.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744773|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-1.6||||0.419|2-Sided|95.0|-5.5|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744774|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-0.1||||0.954|2-Sided|95.0|-4.0|3.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744775|NCT00406029|3208054|Superiority or Other||Difference in LS Means|0.3||||0.861|2-Sided|95.0|-3.5|4.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744776|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-2.2||||0.288|2-Sided|95.0|-6.4|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744777|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-1.0||||0.621|2-Sided|95.0|-5.2|3.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744778|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-0.4||||0.861|2-Sided|95.0|-4.5|3.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744779|NCT00406029|3208054|Superiority or Other||Difference in LS Means|0.8||||0.731|2-Sided|95.0|-3.6|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744780|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-3.4||||0.099|2-Sided|95.0|-7.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744781|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-2.5||||0.208|2-Sided|95.0|-6.5|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744782|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-3.7||||0.068|2-Sided|95.0|-7.6|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744783|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-1.3||||0.546|2-Sided|95.0|-5.4|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744784|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-3.0||||0.148|2-Sided|95.0|-7.0|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744785|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-1.3||||0.525|2-Sided|95.0|-5.3|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744786|NCT00406029|3208054|Superiority or Other||Difference in LS Means|1.1||||0.562|2-Sided|95.0|-2.8|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744787|NCT00406029|3208054|Superiority or Other||Difference in LS Means|1.7||||0.419|2-Sided|95.0|-2.5|5.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744788|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-1.9||||0.343|2-Sided|95.0|-6.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744789|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-1.0||||0.608|2-Sided|95.0|-4.9|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744790|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-0.9||||0.646|2-Sided|95.0|-4.7|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744791|NCT00406029|3208054|Superiority or Other||Difference in LS Means|1.2||||0.54|2-Sided|95.0|-2.6|5.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744792|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-4.8||||0.01|2-Sided|95.0|-8.5|-1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744793|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-2.7||||0.154|2-Sided|95.0|-6.4|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744794|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-1.4||||0.448|2-Sided|95.0|-5.1|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744795|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-2.3||||0.224|2-Sided|94.0|-6.0|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744796|NCT00406029|3208054|Superiority or Other||Difference in LS Means|-3.1||||0.103|2-Sided|95.0|-6.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744797|NCT00406029|3208054|Superiority or Other||Difference in LS Means|1.8||||0.343|2-Sided|95.0|-2.0|5.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744798|NCT00406029|3208054|Superiority or Other||Difference in LS Means|1.4||||0.476|2-Sided|95.0|-2.4|5.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744799|NCT00406029|3208054|Superiority or Other||Difference in LS Means|1.7||||0.365|2-Sided|95.0|-2.0|5.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744800|NCT00406029|3208055|Superiority or Other||Difference in LS Means|0.2||||0.832|2-Sided|95.0|-1.3|1.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744801|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-1.5||||0.058|2-Sided|95.0|-3.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744802|NCT00406029|3208055|Superiority or Other||Difference in LS Means|0.1||||0.898|2-Sided|95.0|-1.4|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744803|NCT00406029|3208055|Superiority or Other||Difference in LS Means|0.7||||0.331|2-Sided|95.0|-0.8|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744804|NCT00406029|3208055|Superiority or Other||Difference in LS Means|0.0||||0.963|2-Sided|95.0|-1.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744805|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-1.9||||0.024|2-Sided|95.0|-3.5|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744806|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-0.2||||0.784|2-Sided|95.0|-1.8|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744807|NCT00406029|3208055|Superiority or Other||Difference in LS Means|0.4||||0.621|2-Sided|95.0|-1.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744808|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-0.2||||0.796|2-Sided|95.0|-1.9|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744809|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-1.4||||0.087|2-Sided|95.0|-3.1|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744810|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-0.3||||0.753|2-Sided|95.0|-1.9|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744811|NCT00406029|3208055|Superiority or Other||Difference in LS Means|0.2||||0.801|2-Sided|95.0|-1.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744812|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-0.8||||0.267|2-Sided|95.0|-2.3|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744813|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-1.3||||0.082|2-Sided|95.0|-2.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744814|NCT00406029|3208055|Superiority or Other||Difference in LS Means|0.1||||0.942|2-Sided|95.0|-1.4|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744815|NCT00406029|3208055|Superiority or Other||Difference in LS Means|0.7||||0.372|2-Sided|95.0|-0.8|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744816|NCT00406029|3208055|Superiority or Other||Difference in LS Means|0.5||||0.547|2-Sided|95.0|-1.1|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744817|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-1.0||||0.174|2-Sided|95.0|-2.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744818|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-0.6||||0.416|2-Sided|95.0|-2.1|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744819|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-0.2||||0.758|2-Sided|95.0|-1.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745248|NCT00402987|3208368|Superiority or Other|||||||0.008|||||||Regression, Logistic|Treatment as a factor|||
1744820|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-0.8||||0.272|2-Sided|95.0|-2.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744821|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-1.0||||0.195|2-Sided|95.0|-2.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744822|NCT00406029|3208055|Superiority or Other||Difference in LS Means|0.4||||0.581|2-Sided|95.0|-1.1|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744823|NCT00406029|3208055|Superiority or Other||Difference in LS Means|0.2||||0.757|2-Sided|94.0|-1.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744824|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-0.9||||0.173|2-Sided|95.0|-2.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744825|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-0.8||||0.252|2-Sided|95.0|-2.2|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744826|NCT00406029|3208055|Superiority or Other||Difference in LS Means|-0.8||||0.225|2-Sided|95.0|-2.2|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744827|NCT00406029|3208055|Superiority or Other||Difference in LS Means|0.2||||0.743|2-Sided|95.0|-1.1|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744828|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.6||||0.04|2-Sided|95.0|-1.1|0.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744829|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.8||||0.004|2-Sided|95.0|-1.4|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744830|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.2||||0.439|2-Sided|95.0|-0.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744831|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.3||||0.345|2-Sided|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744832|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.5||||0.06|2-Sided|95.0|-1.1|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744833|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.9||||0.004|2-Sided|95.0|-1.4|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744834|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.3||||0.286|2-Sided|95.0|-0.9|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744835|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.2||||0.511|2-Sided|95.0|-0.8|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744836|NCT00406029|3208056|Superiority or Other||Difference in LS Means|0.0||||0.86|2-Sided|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744837|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.5||||0.096|2-Sided|95.0|-1.0|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744838|NCT00406029|3208056|Superiority or Other||Difference in LS Means|0.1||||0.651|2-Sided|95.0|-0.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744839|NCT00406029|3208056|Superiority or Other||Difference in LS Means|0.2||||0.422|2-Sided|95.0|-0.3|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744840|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.4||||0.175|2-Sided|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744841|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.7||||0.018|2-Sided|95.0|-1.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744842|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.2||||0.456|2-Sided|95.0|-0.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744843|NCT00406029|3208056|Superiority or Other||Difference in LS Means|0.0||||0.971|2-Sided|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744844|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.4||||0.12|2-Sided|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744845|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.7||||0.013|2-Sided|95.0|-1.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745055|NCT00405912|3208076|Superiority or Other|||||||0.73|||||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.|
1744846|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.3||||0.175|2-Sided|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744847|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.4||||0.15|2-Sided|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744848|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.4||||0.161|2-Sided|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744849|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.4||||0.102|2-Sided|95.0|-1.0|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744850|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.3||||0.343|2-Sided|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744851|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.3||||0.256|2-Sided|94.0|-0.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744852|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.7||||0.005|2-Sided|95.0|-1.2|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744853|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.4||||0.148|2-Sided|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744854|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.4||||0.14|2-Sided|95.0|-0.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744855|NCT00406029|3208056|Superiority or Other||Difference in LS Means|-0.1||||0.747|2-Sided|95.0|-0.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744856|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.0||||0.868|2-Sided|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744857|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.0||||0.906|2-Sided|95.0|-0.6|0.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744858|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.3||||0.211|2-Sided|95.0|-0.2|0.9|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744859|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.1||||0.742|2-Sided|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744860|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.1||||0.72|2-Sided|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744861|NCT00406029|3208063|Superiority or Other||Difference in LS Means|-0.2||||0.55|2-Sided|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744862|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.3||||0.282|2-Sided|95.0|-0.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744863|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.0||||0.981|2-Sided|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744864|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.3||||0.371|2-Sided|95.0|-0.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744865|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.1||||0.702|2-Sided|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744866|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.1||||0.786|2-Sided|95.0|-0.5|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744867|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.0||||0.988|2-Sided|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744868|NCT00406029|3208063|Superiority or Other||Difference in LS Means|-0.1||||0.796|2-Sided|95.0|-0.7|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744869|NCT00406029|3208063|Superiority or Other||Difference in LS Means|-0.3||||0.428|2-Sided|95.0|-0.9|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744870|NCT00406029|3208063|Superiority or Other||Difference in LS Means|-0.1||||0.766|2-Sided|95.0|-0.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744871|NCT00406029|3208063|Superiority or Other||Difference in LS Means|-0.2||||0.597|2-Sided|95.0|-0.8|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745056|NCT00405912|3208076|Superiority or Other|||||||0.52|||||||Fisher Exact|1 sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.|
1744872|NCT00406029|3208063|Superiority or Other||Difference in LS Means|-0.2||||0.516|2-Sided|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744873|NCT00406029|3208063|Superiority or Other||Difference in LS Means|-0.3||||0.269|2-Sided|95.0|-0.9|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744874|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.2||||0.512|2-Sided|95.0|-0.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744875|NCT00406029|3208063|Superiority or Other||Difference in LS Means|-0.1||||0.612|2-Sided|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744876|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.1||||0.673|2-Sided|95.0|-0.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744877|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.1||||0.843|2-Sided|95.0|-0.5|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744878|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.4||||0.155|2-Sided|95.0|-0.1|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744879|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.0||||0.92|2-Sided|94.0|-0.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744880|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.1||||0.777|2-Sided|95.0|-0.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744881|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.1||||0.776|2-Sided|95.0|-0.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744882|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.1||||0.556|2-Sided|95.0|-0.3|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744883|NCT00406029|3208063|Superiority or Other||Difference in LS Means|0.0||||0.985|2-Sided|95.0|-0.5|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744884|NCT00406029|3208064|Superiority or Other||Difference in LS Means|1.3||||0.054|2-Sided|95.0|0.0|2.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744885|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.9||||0.185|2-Sided|95.0|-0.4|2.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744886|NCT00406029|3208064|Superiority or Other||Difference in LS Means|1.2||||0.074|2-Sided|95.0|-0.1|2.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744887|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.1||||0.903|2-Sided|95.0|-1.2|1.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744888|NCT00406029|3208064|Superiority or Other||Difference in LS Means|1.7||||0.022|2-Sided|95.0|0.3|3.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744889|NCT00406029|3208064|Superiority or Other||Difference in LS Means|1.3||||0.103|2-Sided|95.0|-0.3|2.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744890|NCT00406029|3208064|Superiority or Other||Difference in LS Means|1.5||||0.051|2-Sided|95.0|0.0|3.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744891|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.7||||0.415|2-Sided|95.0|-0.9|2.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744892|NCT00406029|3208064|Superiority or Other||Difference in LS Means|1.2||||0.102|2-Sided|95.0|-0.2|2.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744893|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.5||||0.471|2-Sided|95.0|-0.9|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744894|NCT00406029|3208064|Superiority or Other||Difference in LS Means|1.2||||0.093|2-Sided|95.0|-0.2|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744895|NCT00406029|3208064|Superiority or Other||Difference in LS Means|-0.1||||0.847|2-Sided|95.0|-1.5|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744896|NCT00406029|3208064|Superiority or Other||Difference in LS Means|1.2||||0.099|2-Sided|95.0|-0.2|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744897|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.6||||0.431|2-Sided|95.0|-0.9|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745164|NCT00403546|3208317|Superiority||Mean Difference (Net)|0.5||||0.38|2-Sided|95.0|-0.62|1.62|||Mixed Models Analysis|||At Week 6|
1744898|NCT00406029|3208064|Superiority or Other||Difference in LS Means|1.3||||0.057|2-Sided|95.0|0.0|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744899|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.0||||0.995|2-Sided|95.0|-1.5|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744900|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.5||||0.478|2-Sided|95.0|-0.9|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744901|NCT00406029|3208064|Superiority or Other||Difference in LS Means|-0.1||||0.925|2-Sided|95.0|-1.5|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744902|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.4||||0.597|2-Sided|95.0|-1.0|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744903|NCT00406029|3208064|Superiority or Other||Difference in LS Means|-0.7||||0.311|2-Sided|95.0|-2.2|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744904|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.4||||0.518|2-Sided|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744905|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.1||||0.897|2-Sided|95.0|-1.1|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744906|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.0||||0.938|2-Sided|95.0|-1.1|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744907|NCT00406029|3208064|Superiority or Other||Difference in LS Means|-0.6||||0.348|2-Sided|94.0|-1.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744908|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.8||||0.107|2-Sided|95.0|-0.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744909|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.3||||0.596|2-Sided|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744910|NCT00406029|3208064|Superiority or Other||Difference in LS Means|0.3||||0.468|2-Sided|95.0|-0.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744911|NCT00406029|3208064|Superiority or Other||Difference in LS Means|-0.4||||0.345|2-Sided|95.0|-1.4|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744912|NCT00406029|3208065|Superiority or Other||Difference in LS Means|1.1||||0.047|2-Sided|95.0|0.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744913|NCT00406029|3208065|Superiority or Other||Difference in LS Means|1.0||||0.064|2-Sided|95.0|-0.1|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744914|NCT00406029|3208065|Superiority or Other||Difference in LS Means|1.2||||0.025|2-Sided|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744915|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.4||||0.428|2-Sided|95.0|-0.6|1.5|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744916|NCT00406029|3208065|Superiority or Other||Difference in LS Means|1.5||||0.021|2-Sided|95.0|0.2|2.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744917|NCT00406029|3208065|Superiority or Other||Difference in LS Means|1.2||||0.059|2-Sided|95.0|0.0|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744918|NCT00406029|3208065|Superiority or Other||Difference in LS Means|1.4||||0.03|2-Sided|95.0|0.1|2.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744919|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.8||||0.228|2-Sided|95.0|-0.5|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744920|NCT00406029|3208065|Superiority or Other||Difference in LS Means|1.2||||0.047|2-Sided|95.0|0.0|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744921|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.7||||0.24|2-Sided|95.0|-0.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744922|NCT00406029|3208065|Superiority or Other||Difference in LS Means|1.2||||0.041|2-Sided|95.0|0.1|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744923|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.3||||0.572|2-Sided|95.0|-0.9|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745249|NCT00402987|3208368|Superiority or Other|||||||0.001|||||||Regression, Logistic|Treatment as a factor|||
1744924|NCT00406029|3208065|Superiority or Other||Difference in LS Means|1.2||||0.051|2-Sided|95.0|0.0|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744925|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.8||||0.214|2-Sided|95.0|-0.4|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744926|NCT00406029|3208065|Superiority or Other||Difference in LS Means|1.3||||0.032|2-Sided|95.0|0.1|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744927|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.4||||0.571|2-Sided|95.0|-0.9|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744928|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.7||||0.241|2-Sided|95.0|-0.5|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744929|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.6||||0.296|2-Sided|95.0|-0.5|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744930|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.6||||0.285|2-Sided|95.0|-0.5|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744931|NCT00406029|3208065|Superiority or Other||Difference in LS Means|-0.1||||0.925|2-Sided|95.0|-1.2|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744932|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.4||||0.38|2-Sided|95.0|-0.5|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744933|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.4||||0.478|2-Sided|95.0|-0.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744934|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.2||||0.625|2-Sided|95.0|-0.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744935|NCT00406029|3208065|Superiority or Other||Difference in LS Means|-0.2||||0.696|2-Sided|94.0|-1.2|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744936|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.9||||0.035|2-Sided|95.0|0.1|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744937|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.5||||0.204|2-Sided|95.0|-0.3|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744938|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.8||||0.042|2-Sided|95.0|0.0|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744939|NCT00406029|3208065|Superiority or Other||Difference in LS Means|0.1||||0.829|2-Sided|95.0|-0.7|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744940|NCT00406029|3208066|Superiority or Other||Difference in LS Means|0.2||||0.54|2-Sided|95.0|-0.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744941|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.1||||0.812|2-Sided|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744942|NCT00406029|3208066|Superiority or Other||Difference in LS Means|0.0||||0.909|2-Sided|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744943|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.3||||0.432|2-Sided|95.0|-1.0|0.4|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744944|NCT00406029|3208066|Superiority or Other||Difference in LS Means|0.3||||0.477|2-Sided|95.0|-0.5|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744945|NCT00406029|3208066|Superiority or Other||Difference in LS Means|0.1||||0.863|2-Sided|95.0|-0.8|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744946|NCT00406029|3208066|Superiority or Other||Difference in LS Means|0.1||||0.755|2-Sided|95.0|-0.7|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744947|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.1||||0.849|2-Sided|95.0|-1.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744948|NCT00406029|3208066|Superiority or Other||Difference in LS Means|0.0||||0.925|2-Sided|95.0|-0.8|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744949|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.2||||0.626|2-Sided|95.0|-0.9|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745057|NCT00405912|3208077|Superiority or Other|||||||0.25|||||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.|
1744950|NCT00406029|3208066|Superiority or Other||Difference in LS Means|0.0||||0.976|2-Sided|95.0|-0.7|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744951|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.4||||0.264|2-Sided|95.0|-1.2|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744952|NCT00406029|3208066|Superiority or Other||Difference in LS Means|0.0||||0.924|2-Sided|95.0|-0.7|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744953|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.1||||0.715|2-Sided|95.0|-0.9|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744954|NCT00406029|3208066|Superiority or Other||Difference in LS Means|0.1||||0.764|2-Sided|95.0|-0.6|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744955|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.3||||0.501|2-Sided|95.0|-1.0|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744956|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.2||||0.686|2-Sided|95.0|-0.9|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744957|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.7||||0.09|2-Sided|95.0|-1.5|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744958|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.2||||0.597|2-Sided|95.0|-1.0|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744959|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.5||||0.185|2-Sided|95.0|-1.3|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744960|NCT00406029|3208066|Superiority or Other||Difference in LS Means|0.0||||0.991|2-Sided|95.0|-0.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744961|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.2||||0.424|2-Sided|95.0|-0.8|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744962|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.2||||0.611|2-Sided|95.0|-0.7|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744963|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.3||||0.342|2-Sided|94.0|-0.9|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744964|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.1||||0.764|2-Sided|95.0|-0.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744965|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.3||||0.288|2-Sided|95.0|-0.8|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744966|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.5||||0.071|2-Sided|95.0|-1.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744967|NCT00406029|3208066|Superiority or Other||Difference in LS Means|-0.5||||0.055|2-Sided|95.0|-1.0|0.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744968|NCT00406029|3208067|Superiority or Other||Difference in LS Means|-0.2||||0.769|2-Sided|95.0|-1.7|1.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744969|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.3||||0.654|2-Sided|95.0|-1.1|1.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744970|NCT00406029|3208067|Superiority or Other||Difference in LS Means|-0.7||||0.368|2-Sided|95.0|-2.1|0.8|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744971|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.1||||0.907|2-Sided|95.0|-1.4|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744972|NCT00406029|3208067|Superiority or Other||Difference in LS Means|-0.4||||0.607|2-Sided|95.0|-2.1|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744973|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.4||||0.621|2-Sided|95.0|-1.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744974|NCT00406029|3208067|Superiority or Other||Difference in LS Means|-0.8||||0.374|2-Sided|95.0|-2.4|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744975|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.3||||0.759|2-Sided|95.0|-1.5|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745058|NCT00405912|3208077|Superiority or Other|||||||0.51|||||||Fisher Exact|1-sided test||Data were compared between treatment groups using Fisher's exact test for binary outcomes.|
1744976|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.1||||0.93|2-Sided|95.0|-1.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744977|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.9||||0.245|2-Sided|95.0|-0.6|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744978|NCT00406029|3208067|Superiority or Other||Difference in LS Means|-0.4||||0.558|2-Sided|95.0|-1.9|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744979|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.2||||0.842|2-Sided|95.0|-1.4|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744980|NCT00406029|3208067|Superiority or Other||Difference in LS Means|-0.4||||0.603|2-Sided|95.0|-1.9|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744981|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.4||||0.576|2-Sided|95.0|-1.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744982|NCT00406029|3208067|Superiority or Other||Difference in LS Means|-0.6||||0.411|2-Sided|95.0|-2.0|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744983|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.6||||0.449|2-Sided|95.0|-0.9|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744984|NCT00406029|3208067|Superiority or Other||Difference in LS Means|-0.1||||0.864|2-Sided|95.0|-1.6|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744985|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.6||||0.411|2-Sided|95.0|-0.8|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744986|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.0||||0.967|2-Sided|95.0|-1.4|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744987|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.4||||0.543|2-Sided|95.0|-1.0|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744988|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.0||||0.968|2-Sided|95.0|-1.3|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744989|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.5||||0.415|2-Sided|95.0|-0.7|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744990|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.3||||0.673|2-Sided|95.0|-1.0|1.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744991|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.8||||0.222|2-Sided|94.0|-0.5|2.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744992|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.2||||0.746|2-Sided|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744993|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.5||||0.343|2-Sided|95.0|-0.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744994|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.0||||0.93|2-Sided|95.0|-1.1|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744995|NCT00406029|3208067|Superiority or Other||Difference in LS Means|0.8||||0.151|2-Sided|95.0|-0.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744996|NCT00406029|3208068|Superiority or Other||Difference in LS Means|1.1||||0.049|2-Sided|95.0|0.0|2.1|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744997|NCT00406029|3208068|Superiority or Other||Difference in LS Means|1.2||||0.024|2-Sided|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744998|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.5||||0.341|2-Sided|95.0|-0.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1744999|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.2||||0.757|2-Sided|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745000|NCT00406029|3208068|Superiority or Other||Difference in LS Means|1.3||||0.033|2-Sided|95.0|0.1|2.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745001|NCT00406029|3208068|Superiority or Other||Difference in LS Means|1.7||||0.007|2-Sided|95.0|0.5|2.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745165|NCT00403546|3208317|Superiority||Mean Difference (Net)|0.73||||0.171|2-Sided|95.0|-0.32|1.77|||Mixed Models Analysis|||At Week 4|
1745002|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.7||||0.235|2-Sided|95.0|-0.5|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745003|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.9||||0.151|2-Sided|95.0|-0.3|2.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745004|NCT00406029|3208068|Superiority or Other||Difference in LS Means|1.2||||0.025|2-Sided|95.0|0.2|2.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745005|NCT00406029|3208068|Superiority or Other||Difference in LS Means|1.4||||0.012|2-Sided|95.0|0.3|2.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745006|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.8||||0.152|2-Sided|95.0|-0.3|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745007|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.0||||0.954|2-Sided|95.0|-1.1|1.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745008|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.9||||0.144|2-Sided|95.0|-0.3|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745009|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.9||||0.106|2-Sided|95.0|-0.2|2.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745010|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.8||||0.136|2-Sided|95.0|-0.3|1.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745011|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.6||||0.309|2-Sided|95.0|-0.6|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745012|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.4||||0.523|2-Sided|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745013|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.5||||0.45|2-Sided|95.0|-0.8|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745014|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.4||||0.466|2-Sided|95.0|-0.8|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745015|NCT00406029|3208068|Superiority or Other||Difference in LS Means|-0.3||||0.68|2-Sided|95.0|-1.5|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745016|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.4||||0.451|2-Sided|95.0|-0.6|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745017|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.5||||0.305|2-Sided|95.0|-0.5|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745018|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.4||||0.489|2-Sided|95.0|-0.7|1.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745019|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.2||||0.684|2-Sided|94.0|-0.8|1.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745020|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.9||||0.042|2-Sided|95.0|0.0|1.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745021|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.7||||0.114|2-Sided|95.0|-0.2|1.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745022|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.3||||0.505|2-Sided|95.0|-0.6|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745023|NCT00406029|3208068|Superiority or Other||Difference in LS Means|0.3||||0.47|2-Sided|95.0|-0.6|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745024|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-1.4||||0.011|2-Sided|95.0|-2.5|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745025|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-1.2||||0.04||95.0|-2.3|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745026|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.9||||0.095|2-Sided|95.0|-2.0|0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745027|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.6||||0.293|2-Sided|95.0|-1.8|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 12 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745059|NCT00405821|3208081|Superiority or Other||Mean Difference (Final Values)|-0.463||||0.05|2-Sided|95.0|-0.731|-0.194|||t-test, 2 sided|||Null hypothesis is no difference in annual rate of change in log10 viral load by arm.|
1745028|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-1.5||||0.005|2-Sided|95.0|-2.5|-0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745029|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-1.3||||0.013|2-Sided|95.0|-2.3|-0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745030|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.9||||0.092|2-Sided|95.0|-1.9|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745031|NCT00406029|3208069|Superiority or Other||Difference in LS Means|0.2||||0.762|2-Sided|95.0|-0.9|1.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 10 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745032|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-1.2||||0.034|2-Sided|95.0|-2.2|-0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745033|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.5||||0.292|2-Sided|95.0|-1.6|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745034|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.7||||0.156|2-Sided|95.0|-1.7|0.3|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745035|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.3||||0.562|2-Sided|95.0|-1.4|0.7|||ANCOVA|||LS means treatment difference in change from baseline to Week 8 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745036|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.2||||0.707|2-Sided|95.0|-1.3|0.9|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745037|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.5||||0.377|2-Sided|95.0|-1.6|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745038|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.6||||0.299|2-Sided|95.0|-1.7|0.5|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745039|NCT00406029|3208069|Superiority or Other||Difference in LS Means|0.5||||0.378|2-Sided|95.0|-0.6|1.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 6 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745040|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.4||||0.447|2-Sided|95.0|-1.4|0.6|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745041|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.6||||0.261|2-Sided|95.0|-1.6|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745042|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.5||||0.281|2-Sided|95.0|-1.5|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745043|NCT00406029|3208069|Superiority or Other||Difference in LS Means|0.0||||0.982|2-Sided|95.0|-1.0|1.0|||ANCOVA|||LS means treatment difference in change from baseline to Week 4 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745044|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-1.0||||0.02|2-Sided|95.0|-1.9|-0.2|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745045|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.8||||0.07|2-Sided|95.0|-1.7|0.1|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745046|NCT00406029|3208069|Superiority or Other||Difference in LS Means|-0.4||||0.326|2-Sided|95.0|-1.3|0.4|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745047|NCT00406029|3208069|Superiority or Other||Difference in LS Means|0.0||||0.935|2-Sided|95.0|-0.9|0.8|||ANCOVA|||LS means treatment difference in change from baseline to Week 2 obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745048|NCT00406029|3208070|Superiority or Other||Difference in LS Means|-1.2||||0.019|2-Sided|95.0|-2.2|-0.2||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745049|NCT00406029|3208070|Superiority or Other||Difference in LS Means|-1.0||||0.049|2-Sided|95.0|-2.1|0.0||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745050|NCT00406029|3208070|Superiority or Other||Difference in LS Means|-0.7||||0.162|2-Sided|95.0|-1.7|0.3||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline at endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745051|NCT00406029|3208070|Superiority or Other||Difference in LS Means|0.2||||0.753|2-Sided|95.0|-0.9|1.2||The alpha threshold for statistical significance is 0.049 (2-sided).|ANCOVA|||LS means treatment difference in change from baseline to endpoint obtained from an ANCOVA model with effect for treatment and baseline covariate.|
1745052|NCT00405964|3208071|Superiority or Other||||||<|0.001||||||Same p-value for treatment and site.|ANOVA||||
1745053|NCT00405964|3208072|Superiority or Other|||||||0.035||||||Determined for site. Treatment p-value <.001|ANOVA||||
1745054|NCT00405964|3208073|Superiority or Other||||||<|0.001||||||Determined for site. P-value of <.001 for treatment as well.|ANOVA||||
1745098|NCT00405392|3208173|Superiority or Other|||||||0.9456|||||||t-test, 2 sided||||
1745060|NCT00405821|3208082|Superiority or Other||Risk Ratio (RR)|0.31|||<|0.05|2-Sided|95.0|0.19|0.48||we included multiple GUD events per subject in the estimate of GUD incidence|rate ratio with 95% CI|||Null hypothesis is no difference by treatment arm in rate of GUD.|
1745061|NCT00405821|3208083|Superiority or Other||Hazard Ratio (HR)|0.75|||<|0.05|2-Sided|95.0|0.58|0.99||P-value was adjusted to include multiple looks at data including an interim efficacy review at 50% and 75% accrual of person-years on study|Regression, Cox|adjusted for baseline log10 viral load, baseline CD4 count, gender, and age||Intent-to-treat analysis used Cox proportional hazards (CPH) models, adjusting for baseline log10 viral load (VL), CD4 cell count, gender and age to assess the risk of disease progression|
1745062|NCT00405756|3208104|Superiority or Other||Hazard Ratio (HR)|0.827||||0.169|2-Sided|95.0|0.63|1.085||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank||||
1745063|NCT00405756|3208104|Superiority or Other||Hazard Ratio (HR)|0.499|||<|0.001|2-Sided|95.0|0.363|0.688||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank||||
1745064|NCT00405756|3208104|Superiority or Other||Hazard Ratio (HR)|0.404|||<|0.001|2-Sided|95.0|0.296|0.553||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank||||
1745065|NCT00405756|3208105|Superiority or Other||Hazard Ratio (HR)|0.825||||0.302|2-Sided|95.0|0.571|1.191||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank||||
1745066|NCT00405756|3208105|Superiority or Other||Hazard Ratio (HR)|0.419|||<|0.001|2-Sided|95.0|0.281|0.623||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank||||
1745067|NCT00405756|3208105|Superiority or Other||Hazard Ratio (HR)|0.348|||<|0.001|2-Sided|95.0|0.228|0.531||The p-value is based on unstratified log rank test of Kaplan Meier curve differences between the treatment groups.|Log Rank||||
1745068|NCT00405756|3208107|Superiority or Other||Odds Ratio (OR)|2.12||||0.002|2-Sided|95.0|1.33|3.37|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE|
1745069|NCT00405756|3208107|Superiority or Other||Odds Ratio (OR)|1.58||||0.096|2-Sided|95.0|0.95|2.62|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE|
1745070|NCT00405756|3208107|Superiority or Other||Odds Ratio (OR)|3.34|||<|0.001|2-Sided|95.0|2.04|5.47|||Fisher Exact|||Based on dichotomized response: 1) CR or PR 2) SD or PD or NE|
1745071|NCT00405756|3208107|Superiority or Other||||||<|0.003||||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)||||
1745072|NCT00405756|3208107|Superiority or Other||||||<|0.009||||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)||||
1745073|NCT00405756|3208107|Superiority or Other||||||<|0.001||||||P-value calculation excludes the category - Response not evaluable (NE)|Wilcoxon (Mann-Whitney)||||
1745074|NCT00405756|3208108|Superiority or Other||Hazard Ratio (HR)|0.826||||0.223|2-Sided|95.0|0.606|1.125||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank||||
1745075|NCT00405756|3208108|Superiority or Other||Hazard Ratio (HR)|0.414|||<|0.001|2-Sided|95.0|0.284|0.603||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank||||
1745076|NCT00405756|3208108|Superiority or Other||Hazard Ratio (HR)|0.337|||<|0.001|2-Sided|95.0|0.231|0.493||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank||||
1745077|NCT00405756|3208110|Superiority or Other||Hazard Ratio (HR)|0.34|||<|0.001|2-Sided|95.0|0.214|0.541|||Log Rank|P-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|||
1745078|NCT00405756|3208111|Superiority or Other||Hazard Ratio (HR)|0.796||||0.134|2-Sided|95.0|0.589|1.075||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank||||
1745079|NCT00405756|3208111|Superiority or Other||Hazard Ratio (HR)|0.494|||<|0.001|2-Sided|95.0|0.347|0.702||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank||||
1745080|NCT00405756|3208111|Superiority or Other||Hazard Ratio (HR)|0.395|||<|0.001|2-Sided|95.0|0.278|0.56||The p-value is based on unstratified log rank test of Kaplan-Meier curve differences between the treatment groups.|Log Rank||||
1745081|NCT00405704|3208112|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1745082|NCT00405704|3208113|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1745083|NCT00405704|3208114|Superiority or Other (legacy)|||||||0.065|||||||Cochran-Mantel-Haenszel||||
1745084|NCT00405704|3208115|Superiority or Other (legacy)|||||||0.04|||||||Log Rank||||
1745085|NCT00405704|3208116|Superiority or Other (legacy)|||||||0.94|||||||Cochran-Mantel-Haenszel||||
1745086|NCT00405704|3208117|Superiority or Other (legacy)|||||||0.37|||||||Cochran-Mantel-Haenszel||||
1745087|NCT00405704|3208118|Superiority or Other (legacy)|||||||0.55|||||||Cochran-Mantel-Haenszel||||
1745088|NCT00405704|3208119|Superiority or Other (legacy)||||||<|0.001|||||||Log Rank||||
1745089|NCT00405639|3208122|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1745090|NCT00405639|3208123|Superiority or Other|||||||0.07|||||||t-test, 2 sided||||
1745091|NCT00405639|3208124|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1745092|NCT00405639|3208125|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1745093|NCT00405548|3208161|Superiority or Other|||||||0.43|||||||t-test, 2 sided|A p-value of less 0.05 was considered to be statistically significant.||Mean LV filling pressure was compared from baseline to 12 weeks within the Placebo group.|
1745094|NCT00405548|3208161|Superiority or Other|||||||0.004|||||||t-test, 2 sided|A p-value of less 0.05 was considered to be statistically significant.||Mean LV filling pressure was compared from baseline to 12 weeks within the BNP group.|
1745095|NCT00405548|3208162|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1745096|NCT00405548|3208163|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1745097|NCT00405548|3208164|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1745101|NCT00405353|3208176|Other||||||<|0.05|||||||Mixed Models Analysis|Linear regressions were used to determine slopes of brain volume changes. Statistical software package SAS was used to perform the analysis.||Percent change in brain volume against time scatter plot with a Loess regression curve was produced and a first-degree spline model was developed. This model fitted line pieces for pre-treatment and early treatment periods (month -6 to month 3) and treatment response period (months 3-12), and these pieces were joined together to achieve continuity. Slopes of these lines were estimated and compared. A random intercept was set in the model to allow the difference among subjects.|
1745102|NCT00405288|3208178|Superiority or Other||proportions|2.0||||0.35||95.0|||||Fisher Exact||||
1745103|NCT00405288|3208179|Superiority or Other||proportion|2.0||||0.99||95.0|||||Fisher Exact||||
1745104|NCT00405288|3208180|Superiority or Other||proportion|3.0||||0.99||95.0|||||Fisher Exact||||
1745105|NCT00405288|3208181|Superiority or Other||proportion|4.0||||0.99||95.0|||||Fisher Exact||||
1745106|NCT00405288|3208182|Superiority or Other||chi square|10.0||||0.87||95.0|||||McNemar|||The null hypothesis is that the proportion of healthy babies (not requiring NICU (neonatal intensive care unit) or additional medical monitoring) will be the same between the Proctofoam and Control groups.|
1745107|NCT00405288|3208183|Superiority or Other||binary|3.0||||0.31||95.0|||||McNemar|||Low birth weight <2,500g; The null hypothesis is that the proportion of low birth weight babies in the Proctofoam and Control groups will be the same.|
1745108|NCT00405288|3208184|Superiority or Other||chi square|10.0||||0.97||95.0|||||McNemar|||Fetal Distress The null hypothesis is that the proportion of fetal distress in the Proctofoam and Control groups will be the same.|
1745109|NCT00405288|3208185|Superiority or Other||chi square|5.0||||0.55||95.0|||||McNemar|||The null hypothesis is that the proportion of pre-term births in the Proctofoam and Control groups will be the same.|
1745110|NCT00405288|3208186|Superiority or Other||chi square|30.0||||0.003||95.0|||||McNemar|||The null hypothesis is that the proportion of vaginal deliveries in the Proctofoam and Control groups will be the same (ie. there will not be a greater proportion of complicated deliveries in either group).|
1745111|NCT00405288|3208187|Superiority or Other||Mean Difference (Final Values)|1.0|Standard Deviation|3.0||0.16|2-Sided|95.0|0.0|3.0|||Wilcoxon (Mann-Whitney)||||
1745112|NCT00405288|3208188|Superiority or Other||Mean Difference (Final Values)|50.0|Standard Deviation|450.0||0.17|2-Sided|95.0|0.0|200.0|||t-test, 2 sided|||"Null hypothesis: Birth weight in pregnancies exposed to Proctofoam-HC will be the same as control pregnancies.~To detect a clinically significant decrease of 200 g in birth weight at a power of 80% and alpha of 5%, 200 women per group were required. Post hoc power analysis of our cohort revealed that, in fact, we had a 91.5% power to detect a 200 g difference in birth weight between the two groups."|
1745113|NCT00404547|3208245|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||This is an analysis of the change in Asthma Control Questionnaire (ACQ) after 12 weeks of treatment.|
1745114|NCT00404352|3208257|Superiority or Other|||||||0.774|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.|||
1745115|NCT00404352|3208257|Superiority or Other|||||||0.002|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.|||
1745116|NCT00404352|3208257|Superiority or Other||||||<|0.001|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.|||
1745117|NCT00404352|3208258|Superiority or Other|||||||0.009|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.|||
1745118|NCT00404352|3208258|Superiority or Other|||||||0.008|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.|||
1745119|NCT00404352|3208258|Superiority or Other||||||<|0.001|||||||Log Rank|Log-rank test was stratified for controlling randomization stratification factors.|||
1745120|NCT00404248|3208261|Superiority or Other||Mean Difference (Final Values)|6.4||||0.8|2-Sided||||||t-test, 2 sided||||
1745121|NCT00404248|3208262|Superiority or Other||Mean Difference (Final Values)|15.4||||0.6|2-Sided||||||t-test, 2 sided||||
1745122|NCT00404248|3208263|Superiority or Other||Mean Difference (Final Values)|1.3||||0.9|1-Sided||||||t-test, 2 sided||||
1745123|NCT00404079|3208275|Superiority or Other|||||||0.05|||||||Mixed Models Analysis||||
1745124|NCT00404079|3208275|Superiority or Other||Odds Ratio (OR)|4.5|Standard Deviation|4.0||0.05|||||||Mixed Models Analysis|||Null hypothesis was glucosamine sulfate is not superior to placebo to reduce pain and disability associated with chronic low back pain. Power calculation was based on a 3 point difference between the groups with the primary outcome. Data was analysed with linear mixed models|
1745125|NCT00403767|3208282|Superiority or Other||Hazard Ratio (HR)|0.85||||0.073|2-Sided|95.0|0.7|1.02||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.|
1745126|NCT00403767|3208283|Superiority or Other||Hazard Ratio (HR)|0.89||||0.289|2-Sided|95.0|0.73|1.1||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.|
1745127|NCT00403767|3208284|Superiority or Other||Hazard Ratio (HR)|0.81||||0.121|2-Sided|95.0|0.63|1.06||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.|
1745128|NCT00403767|3208285|Superiority or Other||Hazard Ratio (HR)|0.23||||0.003|2-Sided|95.0|0.09|0.61||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.|
1745166|NCT00403546|3208317|Superiority||Mean Difference (Net)|1.02||||0.033|2-Sided|95.0|0.08|1.95|||Mixed Models Analysis|||At Week 2|
1745129|NCT00403767|3208286|Superiority or Other||Hazard Ratio (HR)|0.85||||0.092|2-Sided|95.0|0.7|1.03||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.|
1745130|NCT00403767|3208287|Superiority or Other||Hazard Ratio (HR)|0.85||||0.01|2-Sided|95.0|0.74|0.96||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.|
1745131|NCT00403767|3208288|Superiority or Other||Hazard Ratio (HR)|0.86||||0.034|2-Sided|95.0|0.74|0.99||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.|
1745132|NCT00403767|3208289|Superiority or Other||Hazard Ratio (HR)|1.03||||0.442|2-Sided|95.0|0.96|1.11||The p-value is not adjusted for mulitple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as a covariate||Alternate hypothesis of superiority based on on-treatment data from the safety population.|
1745133|NCT00403767|3208290|Superiority or Other||Hazard Ratio (HR)|0.79||||0.015|2-Sided|95.0|0.65|0.95||The p-value Is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.05 (2-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate||Alternative hypothesis of superiority based on on-treatment data from the safety population.|
1745134|NCT00403767|3208291|Non-Inferiority or Equivalence|Alternative hypothesis of non-inferiority (NI) by a NI margin of 1.46 in hazard ratio (HR) based on on-treatment data from the per protocol population. The required number of primary efficacy endpoint events was determined based on the following assumptions: NI margin of 1.46, 1-sided alpha of 0.025, power of >95% when true HR is 1, and exponential distributions. The margin was selected based on clinical appropriateness and quantitative analysis of relevant studies in Hart et al.|Hazard Ratio (HR)|0.79|||<|0.001|2-Sided|95.0|0.66|0.96||The p-value is not adjusted for multiple comparisons. The alpha threshold for statistical significance is 0.025 (1-sided).|Cox Proportional Hazards model|(non-stratified) Cox Proportional Hazards model with treatment as covariate|||
1745135|NCT00403585|3208301|Superiority or Other||||||<|0.001||||||The p value represents the comparison between baseline data and data at Week 156.|Wilcoxon signed rank||||
1745136|NCT00403546|3208310|Superiority||Mean Difference (Net)|0.57||||0.34|2-Sided|95.0|-0.61|1.76|||Mixed Models Analysis|||At Week 8|
1745137|NCT00403546|3208310|Superiority||Mean Difference (Net)|0.03||||0.95|2-Sided|95.0|-1.01|1.07|||Mixed Models Analysis|||At Week 6|
1745138|NCT00403546|3208310|Superiority||Mean Difference (Net)|0.58||||0.209|2-Sided|95.0|-0.33|1.49|||Mixed Models Analysis|||At Week 4|
1745139|NCT00403546|3208310|Superiority||Mean Difference (Net)|0.44||||0.262|2-Sided|95.0|-0.33|1.21|||Mixed Models Analysis|||At Week 2|
1745140|NCT00403546|3208310|Superiority||Mean Difference (Final Values)|-0.67||||0.135|2-Sided|95.0|-1.55|0.2|||Mixed Models Analysis|||At Baseline|
1745141|NCT00403546|3208312|Superiority||Mean Difference (Net)|-1.37||||0.642|2-Sided|95.0|-7.2|4.45|||Mixed Models Analysis|||At Week 8|
1745142|NCT00403546|3208312|Superiority||Mean Difference (Net)|-3.01||||0.256|2-Sided|95.0|-8.23|2.21|||Mixed Models Analysis|||At Week 6|
1745143|NCT00403546|3208312|Superiority||Mean Difference (Net)|1.95||||0.406|2-Sided|95.0|-2.68|6.58|||Mixed Models Analysis|||At Week 4|
1745144|NCT00403546|3208312|Superiority||Mean Difference (Net)|0.37||||0.854|2-Sided|95.0|-3.59|4.33|||Mixed Models Analysis|||At Week 2|
1745145|NCT00403546|3208312|Superiority||Mean Difference (Final Values)|2.77||||0.416|2-Sided|95.0|-3.97|9.5|||Mixed Models Analysis|Mixed models analysis with random slopes||At Baseline|
1745146|NCT00403546|3208314|Superiority||Mean Difference (Net)|4.38||||0.151|2-Sided|95.0|-1.61|10.37|||Mixed Models Analysis|||DBP at Week 8|
1745147|NCT00403546|3208314|Superiority||Mean Difference (Net)|-2.86||||0.334|2-Sided|95.0|-8.68|2.96|||Mixed Models Analysis|||DBP at Week 6|
1745148|NCT00403546|3208314|Superiority||Mean Difference (Net)|1.02||||0.719|2-Sided|95.0|-4.53|6.56|||Mixed Models Analysis|||DBP at Week 4|
1745149|NCT00403546|3208314|Superiority||Mean Difference (Net)|2.83||||0.268|2-Sided|95.0|-2.18|7.84|||Mixed Models Analysis|||DBP at Week 2|
1745150|NCT00403546|3208314|Superiority||Mean Difference (Net)|1.44||||0.552|2-Sided|95.0|-3.32|6.19|||Mixed Models Analysis|||DBP at Week 1|
1745151|NCT00403546|3208314|Superiority||Mean Difference (Net)|-0.8||||0.741|2-Sided|95.0|-5.62|4.02|||Mixed Models Analysis|||DBP at Baseline|
1745152|NCT00403546|3208314|Superiority||Mean Difference (Net)|6.33||||0.109|2-Sided|95.0|-1.43|14.09|||Mixed Models Analysis|||SBP at Week 8|
1745153|NCT00403546|3208314|Superiority||Mean Difference (Net)|-0.75||||0.842|2-Sided|95.0|-8.13|6.63|||Mixed Models Analysis|||SBP at Week 6|
1745154|NCT00403546|3208314|Superiority||Mean Difference (Net)|3.64||||0.301|2-Sided|95.0|-3.28|10.56|||Mixed Models Analysis|||SBP at Week 4|
1745155|NCT00403546|3208314|Superiority||Mean Difference (Net)|2.83||||0.449|2-Sided|95.0|-3.8|8.57|||Mixed Models Analysis|||SBP at Week 2|
1745156|NCT00403546|3208314|Superiority||Mean Difference (Net)|3.53||||0.235|2-Sided|95.0|-2.31|9.37|||Mixed Models Analysis|||SBP at Week 1|
1745157|NCT00403546|3208314|Superiority||Mean Difference (Net)|-1.82||||0.599|2-Sided|95.0|-8.68|5.05|||Mixed Models Analysis|||SBP at Baseline|
1745158|NCT00403546|3208316|Superiority||Mean Difference (Net)|-0.09||||0.894|2-Sided|95.0|-1.34|1.17|||Mixed Models Analysis|||At Week 8|
1745159|NCT00403546|3208316|Superiority||Mean Difference (Net)|-0.34||||0.57|2-Sided|95.0|-1.5|0.83|||Mixed Models Analysis|||At Week 6|
1745160|NCT00403546|3208316|Superiority||Mean Difference (Net)|0.25||||0.642|2-Sided|95.0|-0.82|1.32|||Mixed Models Analysis|||At Week 4|
1745161|NCT00403546|3208316|Superiority||Mean Difference (Net)|-0.14||||0.764|2-Sided|95.0|-1.09|0.8|||Mixed Models Analysis|||At Week 2|
1745167|NCT00403546|3208317|Superiority||Mean Difference (Final Values)|0.01||||0.98|2-Sided|95.0|-1.09|1.12|||Mixed Models Analysis|||At Baseline|
1745168|NCT00403481|3208319|Superiority or Other||||||<|0.0001||||||<0.0001 applies to both 4 hour and 6 hour analyses|one-sample t-test||||
1745169|NCT00403481|3208320|Superiority or Other||||||<|0.0001|||||||one-sample t-test||||
1745170|NCT00403481|3208321|Superiority or Other||||||<|0.0001||||||<0.0001 applies to both the daytime and nighttime analyses|one-sample t-test||||
1745171|NCT00403481|3208322|Superiority or Other||||||<|0.0001|||||||one-sample t-test||||
1745172|NCT00403481|3208324|Superiority or Other|||||||0.0001||||||No multiplicity adjustments|one-sample t-test||||
1745173|NCT00403481|3208325|Superiority or Other||||||<|0.0001|||||||One-sample t-test||||
1745174|NCT00403481|3208326|Superiority or Other||||||<|0.0001||||||<0.0001 for both daytime and nighttime. No multiplicity adjustments.|one-sample t-test||||
1745175|NCT00403481|3208327|Superiority or Other||||||<|0.0001||||||No multiplicity adjustments|One-sample t-test||||
1745176|NCT00403403|3208329|Superiority or Other||Hazard Ratio (HR)|0.305||||0.0011|2-Sided|95.0|0.144|0.644|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)||
1745177|NCT00403403|3208331|Superiority or Other||Mean Difference (Final Values)|9.7||||0.3269||95.0|-9.6|29.0|||Chi-squared||||
1745178|NCT00403403|3208332|Superiority or Other||Hazard Ratio (HR)|1.16||||0.6054|2-Sided|95.0|0.66|2.039|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)||
1745179|NCT00403403|3208333|Superiority or Other||Hazard Ratio (HR)|0.528||||0.0097||95.0|0.323|0.862|||Log Rank||HR estimated from a stratified Cox regression model, stratified for ECOG performance (0-1 vs. 2) and chemotherapy type (cisplatin vs. carboplatin)||
1745180|NCT00403273|3208335|Superiority|||||||0.03|||||||t-test, 2 sided||||
1745181|NCT00403273|3208336|Superiority|||||||0.03|||||||t-test, 2 sided||||
1745182|NCT00403273|3208337|Superiority|||||||0.046|||||||t-test, 2 sided||||
1745183|NCT00403273|3208338|Superiority|||||||0.004|||||||t-test, 2 sided||||
1745184|NCT00403273|3208339|Superiority|||||||0.01|||||||t-test, 2 sided||||
1745185|NCT00403273|3208340|Superiority or Other||comparison of proportions|0.65|||<|0.05|2-Sided|95.0||||No adjustment for multiple comparisons was made, since we analyzed only one primary outcome. 19 patients per group were needed for 80% power and 24 patients per group for 90% power to detect a difference of 43% in proportion with primary outcome|comparison of proportions|compare proportion of patients with clinically meaningful change in 0-10 VAS pain (at least 2-point reduction on VAS pain) at 2-mths & all timepoints|we hypothesized a greater proportion with meaningful reduction in pain on 0-10 scale in intervention versus placebo group.|For primary outcome analysis, we compared the proportion of responders with clinically meaningful change [improvement] in 0-10 VAS Pain, i.e. those with 2-point reduction in 0-10 VAS pain score at 2-mths, in the 2 groups using comparison of proportions. Proportion of responders were also analyzed at all efficacy timepoints using generalized estimating equation (GEE) modeling. We used GEE for between-group comparisons in secondary outcomes at all efficacy endpoints, adjusted for baseline scores.|
1745186|NCT00403273|3208341|Superiority|||||||0.01||||||p-value not adjusted for multiple comparisons; the a priori threshold for statistical significance was <0.05|t-test, 2 sided||||
1745187|NCT00402987|3208360|Superiority or Other|||||||0.741||||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel||||
1745188|NCT00402987|3208360|Superiority or Other|||||||0.828||||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel||||
1745189|NCT00402987|3208360|Superiority or Other|||||||0.849||||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel||||
1745190|NCT00402987|3208360|Superiority or Other|||||||0.266||||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel||||
1745191|NCT00402987|3208360|Superiority or Other|||||||0.123||||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel||||
1745192|NCT00402987|3208360|Superiority or Other|||||||0.128||||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel||||
1745193|NCT00402987|3208361|Superiority or Other|||||||0.067||||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel||||
1745194|NCT00402987|3208361|Superiority or Other|||||||0.438||||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel||||
1745195|NCT00402987|3208361|Superiority or Other|||||||0.012||||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel||||
1745196|NCT00402987|3208361|Superiority or Other|||||||0.235||||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel||||
1745197|NCT00402987|3208361|Superiority or Other|||||||0.002||||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel||||
1745198|NCT00402987|3208361|Superiority or Other||||||<|0.001||||||"Based on life-table extension of Mantel-Haenszel method.~p-value for general association"|Mantel Haenszel||||
1745199|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|5.5||||0.371||95.0|-6.6|17.7||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect|||
1745200|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|1.3||||0.808||95.0|-9.2|11.8||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect|||
1745201|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|6.8||||0.204||95.0|-3.7|17.4||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect|||
1745202|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|6.2||||0.251||95.0|-4.4|16.8||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect|||
1745203|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|11.7||||0.029||95.0|1.2|22.2||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect|||
1745204|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|13.0||||0.003||95.0|4.4|21.6||Analysis of Global Satisfaction|Generalized linear model|Treatment as a fixed effect|||
1745205|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|3.6||||0.273||95.0|-2.9|10.2||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect|||
1745206|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|4.2||||0.143||95.0|-1.4|9.8||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect|||
1745207|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|7.8||||0.007||95.0|2.2|13.5||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect|||
1745208|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.482||95.0|-7.7|3.6||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect|||
1745209|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|1.6||||0.573||95.0|-4.0|7.2||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect|||
1745210|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|5.8||||0.014||95.0|1.2|10.4||Analysis of Convenience|Generalized linear model|Treatment as a fixed effect|||
1745211|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.572||95.0|-5.6|3.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect|||
1745212|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.846||95.0|-4.1|3.4||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect|||
1745213|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.398||95.0|-5.4|2.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect|||
1745214|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.724||95.0|-4.5|3.1||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect|||
1745215|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.312||95.0|-5.7|1.8||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect|||
1745216|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|-2.3||||0.141||95.0|-5.4|0.8||Analysis of Side Effects|Generalized linear model|Treatment as a fixed effect|||
1745217|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|6.3||||0.266||95.0|-4.8|17.4||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect|||
1745218|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|0.9||||0.849||95.0|-8.6|10.5||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect|||
1745219|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|7.2||||0.141||95.0|-2.4|16.8||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect|||
1745220|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|8.2||||0.096||95.0|-1.5|17.8||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect|||
1745221|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|14.4||||0.003||95.0|4.9|24.0||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect|||
1745222|NCT00402987|3208362|Superiority or Other||Mean Difference (Final Values)|15.4|||<|0.001||95.0|7.5|23.2||Analysis of Effectiveness|Generalized linear model|Treatment as a fixed effect|||
1745223|NCT00402987|3208363|Superiority or Other|||||||0.649|||||||Regression, Logistic|Treatment as a factor|||
1745224|NCT00402987|3208363|Superiority or Other|||||||0.277|||||||Regression, Logistic|Treatment as a factor|||
1745225|NCT00402987|3208363|Superiority or Other|||||||0.579|||||||Regression, Logistic|Treatment as a factor|||
1745226|NCT00402987|3208363|Superiority or Other|||||||0.096|||||||Regression, Logistic|Treatment as a factor|||
1745227|NCT00402987|3208363|Superiority or Other|||||||0.244|||||||Regression, Logistic|Treatment as a factor|||
1745228|NCT00402987|3208363|Superiority or Other|||||||0.007|||||||Regression, Logistic|Treatment as a factor|||
1745229|NCT00402987|3208364|Superiority or Other|||||||0.171|||||||Regression, Logistic|Treatment as a factor|||
1745230|NCT00402987|3208364|Superiority or Other|||||||0.329|||||||Regression, Logistic|Treatment as a factor|||
1745231|NCT00402987|3208364|Superiority or Other|||||||0.539|||||||Regression, Logistic|Treatment as a factor|||
1745232|NCT00402987|3208364|Superiority or Other|||||||0.025|||||||Regression, Logistic|Treatment as a factor|||
1745233|NCT00402987|3208364|Superiority or Other||||||<|0.001|||||||Regression, Logistic|Treatment as a factor|||
1745234|NCT00402987|3208364|Superiority or Other||||||<|0.001|||||||Regression, Logistic|Treatment as a factor|||
1745235|NCT00402987|3208367|Superiority or Other|||||||0.117||||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor|||
1745236|NCT00402987|3208367|Superiority or Other|||||||0.604||||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor|||
1745237|NCT00402987|3208367|Superiority or Other|||||||0.198||||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor|||
1745238|NCT00402987|3208367|Superiority or Other|||||||0.223||||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor|||
1745239|NCT00402987|3208367|Superiority or Other|||||||0.002||||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor|||
1745240|NCT00402987|3208367|Superiority or Other|||||||0.003||||||Analysis at 24 hours|Regression, Logistic|Treatment as a factor|||
1745241|NCT00402987|3208367|Superiority or Other|||||||0.401||||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor|||
1745242|NCT00402987|3208367|Superiority or Other|||||||1||||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor|||
1745243|NCT00402987|3208367|Superiority or Other|||||||0.339||||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor|||
1745244|NCT00402987|3208367|Superiority or Other|||||||0.036||||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor|||
1745245|NCT00402987|3208367|Superiority or Other|||||||0.002||||||Analysis at 12 hours|Regression, Logistic|Treatment as a factor|||
1749077|NCT00363415|3213900|Superiority or Other||||||<|0.023||||||P-value for Sex: Female|Log Rank||||
1745250|NCT00402987|3208369|Superiority or Other|||||||0.038||||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor|||
1745251|NCT00402987|3208369|Superiority or Other|||||||0.463||||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor|||
1745252|NCT00402987|3208369|Superiority or Other|||||||0.095||||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor|||
1745253|NCT00402987|3208369|Superiority or Other|||||||0.219||||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor|||
1745254|NCT00402987|3208369|Superiority or Other||||||<|0.001||||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor|||
1745255|NCT00402987|3208369|Superiority or Other||||||<|0.001||||||Analysis for Much Improvement|Regression, Logistic|Treatment as a factor|||
1745256|NCT00402987|3208369|Superiority or Other||||||<|0.246||||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor|||
1745257|NCT00402987|3208369|Superiority or Other||||||<|0.331||||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor|||
1745258|NCT00402987|3208369|Superiority or Other||||||<|0.709||||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor|||
1745259|NCT00402987|3208369|Superiority or Other||||||<|0.008||||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor|||
1745260|NCT00402987|3208369|Superiority or Other||||||<|0.001||||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor|||
1745261|NCT00402987|3208369|Superiority or Other||||||<|0.001||||||Analysis for Meaningful Relief|Regression, Logistic|Treatment as a factor|||
1745262|NCT00402987|3208370|Superiority or Other|||||||0.798||||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor|||
1745263|NCT00402987|3208370|Superiority or Other|||||||0.001||||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor|||
1745264|NCT00402987|3208370|Superiority or Other|||||||0.001||||||Analysis for Much Improvement at 6 hours|Regression, Logistic|Treatment as a factor|||
1745265|NCT00402987|3208370|Superiority or Other|||||||0.966||||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor|||
1745266|NCT00402987|3208370|Superiority or Other|||||||0.022||||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor|||
1745267|NCT00402987|3208370|Superiority or Other|||||||0.024||||||Analysis for Much Improvement at 2 hours|Regression, Logistic|Treatment as a factor|||
1745268|NCT00402987|3208370|Superiority or Other|||||||0.814||||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor|||
1745269|NCT00402987|3208370|Superiority or Other|||||||0.001||||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor|||
1745270|NCT00402987|3208370|Superiority or Other||||||<|0.001||||||Analysis for meaningful Relief at 6 hours|Regression, Logistic|Treatment as a factor|||
1745271|NCT00402987|3208370|Superiority or Other||||||<|0.453||||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor|||
1745272|NCT00402987|3208370|Superiority or Other||||||<|0.012||||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor|||
1745273|NCT00402987|3208370|Superiority or Other||||||<|0.001||||||Analysis for meaningful Relief at 2 hours|Regression, Logistic|Treatment as a factor|||
1745274|NCT00402987|3208371|Superiority or Other||Odds Ratio (OR)|1.27||||0.624||95.0|0.5|3.3||12 hours >=50% gone|Regression, Logistic|Treatment as a factor|||
1745275|NCT00402987|3208371|Superiority or Other||Odds Ratio (OR)|0.89||||0.779||95.0|0.4|2.0||12 hours >=50% gone|Regression, Logistic|Treatment as a factor|||
1745276|NCT00402987|3208371|Superiority or Other||Odds Ratio (OR)|1.13||||0.775||95.0|0.5|2.7||12 hours >=50% gone|Regression, Logistic|Treatment as a factor|||
1745277|NCT00402987|3208371|Superiority or Other||Odds Ratio (OR)|2.54||||0.063||95.0|0.9|6.8||12 hours >=50% gone|Regression, Logistic|Treatment as a factor|||
1745278|NCT00402987|3208371|Superiority or Other||Odds Ratio (OR)|3.23||||0.016||95.0|1.2|8.4||12 hours >=50% gone|Regression, Logistic|Treatment as a factor|||
1745279|NCT00402987|3208371|Superiority or Other||Odds Ratio (OR)|2.88||||0.014||95.0|1.2|6.7||12 hours >=50% gone|Regression, Logistic|Treatment as a factor|||
1745280|NCT00402987|3208371|Superiority or Other||Odds Ratio (OR)|1.12||||0.814||95.0|0.4|2.8||12 hours >=35% gone|Regression, Logistic|Treatment as a factor|||
1745281|NCT00402987|3208371|Superiority or Other||Odds Ratio (OR)|1.23||||0.602||95.0|0.6|2.7||12 hours >=35% gone|Regression, Logistic|Treatment as a factor|||
1745282|NCT00402987|3208371|Superiority or Other||Odds Ratio (OR)|1.38||||0.431||95.0|0.6|3.0||12 hours >=35% gone|Regression, Logistic|Treatment as a factor|||
1745283|NCT00402987|3208371|Superiority or Other||Odds Ratio (OR)|2.13||||0.095||95.0|0.9|5.1||12 hours >=35% gone|Regression, Logistic|Treatment as a factor|||
1745284|NCT00402987|3208371|Superiority or Other||Odds Ratio (OR)|2.37||||0.052||95.0|1.0|5.7||12 hours >=35% gone|Regression, Logistic|Treatment as a factor|||
1745285|NCT00402987|3208371|Superiority or Other||Odds Ratio (OR)|2.92||||0.004||95.0|1.4|6.1||12 hours >=35% gone|Regression, Logistic|Treatment as a factor|||
1745286|NCT00402987|3208372|Superiority or Other||Odds Ratio (OR)|0.94||||0.863||95.0|0.5|1.9||Analysis for 6 hours >=50% gone|Regression, Logistic|Treatment as a factor|||
1745287|NCT00402987|3208372|Superiority or Other||Odds Ratio (OR)|2.88||||0.014||95.0|1.2|6.7||Analysis for 6 hours >=50% gone|Regression, Logistic|Treatment as a factor|||
1745288|NCT00402987|3208372|Superiority or Other||Odds Ratio (OR)|3.05||||0.009||95.0|1.3|7.0||Analysis for 6 hours >=50% gone|Regression, Logistic|Treatment as a factor|||
1745289|NCT00402987|3208372|Superiority or Other||Odds Ratio (OR)|0.81||||0.511||95.0|0.4|1.5||Analysis for 2 hours >=50% gone|Regression, Logistic|Treatment as a factor|||
1745290|NCT00402987|3208372|Superiority or Other||Odds Ratio (OR)|3.68||||0.003||95.0|1.6|8.7||Analysis for 2 hours >=50% gone|Regression, Logistic|Treatment as a factor|||
1745291|NCT00402987|3208372|Superiority or Other||Odds Ratio (OR)|4.57|||<|0.001||95.0|1.9|10.7||Analysis for 2 hours >=50% gone|Regression, Logistic|Treatment as a factor|||
1745292|NCT00402987|3208372|Superiority or Other||Odds Ratio (OR)|0.9|||<|0.752||95.0|0.5|1.7||Analysis for 6 hours >=35% gone|Regression, Logistic|Treatment as a factor|||
1745293|NCT00402987|3208372|Superiority or Other||Odds Ratio (OR)|3.05|||<|0.004||95.0|1.4|6.5||Analysis for 6 hours >=35% gone|Regression, Logistic|Treatment as a factor|||
1745294|NCT00402987|3208372|Superiority or Other||Odds Ratio (OR)|3.37|||<|0.001||95.0|1.6|7.1||Analysis for 6 hours >=35% gone|Regression, Logistic|Treatment as a factor|||
1745295|NCT00402987|3208372|Superiority or Other||Odds Ratio (OR)|0.72|||<|0.286||95.0|0.4|1.3||Analysis for 2 hours >=35% gone|Regression, Logistic|Treatment as a factor|||
1745296|NCT00402987|3208372|Superiority or Other||Odds Ratio (OR)|2.72|||<|0.005||95.0|1.3|5.5||Analysis for 2 hours >=35% gone|Regression, Logistic|Treatment as a factor|||
1745297|NCT00402987|3208372|Superiority or Other||Odds Ratio (OR)|3.77|||<|0.001||95.0|1.9|7.6||Analysis for 2 hours >=35% gone|Regression, Logistic|Treatment as a factor|||
1745298|NCT00402987|3208373|Superiority or Other||NNT at 12 hours|5.0||||||95.0|3.0|16.7||||||NNT is the inverse of the absolute risk reduction at 12 hours|
1745299|NCT00402987|3208373|Superiority or Other||NNT at 12 hours|7.5||||||95.0|4.3|28.7||||||NNT is the inverse of the absolute risk reduction at 12 hours|
1745300|NCT00402987|3208374|Superiority or Other||NNT at 6 hours|7.5||||||95.0|4.3|32.0||||||NNT is the inverse of the absolute risk reduction at 6 hours|
1745301|NCT00402987|3208374|Superiority or Other||NNT at 6 hours|8.2||||||95.0|4.5|46.4||||||NNT is the inverse of the absolute risk reduction at 6 hours|
1745302|NCT00402987|3208375|Superiority or Other||Mean Difference (Final Values)|1.68||||0.313||95.0|0.6|4.6|||Regression, Logistic|Treatment as a factor|||
1745303|NCT00402987|3208375|Superiority or Other||Odds Ratio (OR)|0.69||||0.381||95.0|0.3|1.6|||Regression, Logistic|Treatment as a factor|||
1745304|NCT00402987|3208375|Superiority or Other||Odds Ratio (OR)|1.16||||0.758||95.0|0.5|2.9|||Regression, Logistic|Treatment as a factor|||
1745305|NCT00402987|3208375|Superiority or Other||Odds Ratio (OR)|2.99||||0.057||95.0|1.0|9.2|||Regression, Logistic|Treatment as a factor|||
1745306|NCT00402987|3208375|Superiority or Other||Odds Ratio (OR)|5.03||||0.003||95.0|1.7|14.5|||Regression, Logistic|Treatment as a factor|||
1745307|NCT00402987|3208375|Superiority or Other||Odds Ratio (OR)|3.46||||0.013||95.0|1.3|9.2|||Regression, Logistic|Treatment as a factor|||
1745308|NCT00402987|3208376|Superiority or Other||Odds Ratio (OR)|1.07||||0.854||95.0|0.5|2.2|||Regression, Logistic|Treatment as a factor|||
1745309|NCT00402987|3208376|Superiority or Other||Odds Ratio (OR)|3.13||||0.015||95.0|1.2|7.9|||Regression, Logistic|Treatment as a factor|||
1745310|NCT00402987|3208376|Superiority or Other||Odds Ratio (OR)|2.93||||0.023||95.0|1.2|7.4|||Regression, Logistic|Treatment as a factor|||
1745311|NCT00402987|3208377|Superiority or Other||Mean Difference (Final Values)|4.77||||0.513||95.0|-9.6|19.1||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745312|NCT00402987|3208377|Superiority or Other||Mean Difference (Final Values)|4.18||||0.507||95.0|-8.2|16.6||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745313|NCT00402987|3208377|Superiority or Other||Mean Difference (Final Values)|-0.59||||0.926||95.0|-13.0|11.8||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745314|NCT00402987|3208377|Superiority or Other||Mean Difference (Final Values)|9.39||||0.138||95.0|-3.0|21.8||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745315|NCT00402987|3208377|Superiority or Other||Mean Difference (Final Values)|14.15||||0.026||95.0|1.7|26.6||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745316|NCT00402987|3208377|Superiority or Other||Mean Difference (Final Values)|13.57||||0.009||95.0|3.4|23.7||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745317|NCT00402987|3208377|Superiority or Other||Mean Difference (Final Values)|4.5||||0.18||95.0|-2.1|11.1||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745318|NCT00402987|3208377|Superiority or Other||Mean Difference (Final Values)|3.11||||0.284||95.0|-2.6|8.8||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745319|NCT00402987|3208377|Superiority or Other||Mean Difference (Final Values)|-1.39||||0.633||95.0|-7.1|4.3||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745320|NCT00402987|3208377|Superiority or Other||Mean Difference (Final Values)|5.96||||0.041||95.0|0.2|11.7||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745321|NCT00402987|3208377|Superiority or Other||Mean Difference (Final Values)|10.46|||<|0.001||95.0|4.7|16.2||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745429|NCT00402987|3208385|Superiority or Other||||||<|0.001||||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745322|NCT00402987|3208377|Superiority or Other||Mean Difference (Final Values)|9.07|||<|0.001||95.0|4.4|13.7||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745323|NCT00402987|3208378|Superiority or Other||Mean Difference (Final Values)|-0.72||||0.531||95.0|-3.0|1.5||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745324|NCT00402987|3208378|Superiority or Other||Mean Difference (Final Values)|4.54|||<|0.001||95.0|2.3|6.8||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745325|NCT00402987|3208378|Superiority or Other||Mean Difference (Final Values)|5.25|||<|0.001||95.0|3.0|7.5||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745326|NCT00402987|3208378|Superiority or Other||Mean Difference (Final Values)|-0.4|||<|0.177||95.0|-1.0|0.2||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745327|NCT00402987|3208378|Superiority or Other||Mean Difference (Final Values)|0.88|||<|0.003||95.0|0.3|1.5||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745328|NCT00402987|3208378|Superiority or Other||Mean Difference (Final Values)|1.28|||<|0.001||95.0|0.7|1.9||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745329|NCT00402987|3208379|Superiority or Other||Odds Ratio (OR)|1.27||||0.624||95.0|0.5|3.3|||Regression, Logistic|Treatment as a factor|||
1745330|NCT00402987|3208379|Superiority or Other||Odds Ratio (OR)|1.0||||1||95.0|0.4|2.2|||Regression, Logistic|Treatment as a factor|||
1745331|NCT00402987|3208379|Superiority or Other||Odds Ratio (OR)|1.27||||0.575||95.0|0.5|3.0|||Regression, Logistic|Treatment as a factor|||
1745332|NCT00402987|3208379|Superiority or Other||Odds Ratio (OR)|1.83||||0.201||95.0|0.7|4.6|||Regression, Logistic|Treatment as a factor|||
1745333|NCT00402987|3208379|Superiority or Other||Odds Ratio (OR)|2.33||||0.064||95.0|1.0|5.7|||Regression, Logistic|Treatment as a factor|||
1745334|NCT00402987|3208379|Superiority or Other||Odds Ratio (OR)|2.33||||0.03||95.0|1.1|5.0|||Regression, Logistic|Treatment as a factor|||
1745335|NCT00402987|3208380|Superiority or Other||Odds Ratio (OR)|1.12||||0.733||95.0|0.6|2.2|||Regression, Logistic|Treatment as a factor|||
1745336|NCT00402987|3208380|Superiority or Other||Odds Ratio (OR)|1.95||||0.076||95.0|0.9|4.1|||Regression, Logistic|Treatment as a factor|||
1745337|NCT00402987|3208380|Superiority or Other||Odds Ratio (OR)|1.73||||0.149||95.0|0.8|3.7|||Regression, Logistic|Treatment as a factor|||
1745338|NCT00402987|3208381|Superiority or Other|||||||0.53||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745339|NCT00402987|3208381|Superiority or Other|||||||0.345||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745340|NCT00402987|3208381|Superiority or Other|||||||0.826||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745341|NCT00402987|3208381|Superiority or Other|||||||0.087||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745342|NCT00402987|3208381|Superiority or Other|||||||0.015||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745343|NCT00402987|3208381|Superiority or Other|||||||0.001||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745344|NCT00402987|3208381|Superiority or Other|||||||0.119||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745345|NCT00402987|3208381|Superiority or Other|||||||0.11||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745346|NCT00402987|3208381|Superiority or Other|||||||0.841||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745347|NCT00402987|3208381|Superiority or Other|||||||0.064||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745348|NCT00402987|3208381|Superiority or Other||||||<|0.001||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745349|NCT00402987|3208381|Superiority or Other||||||<|0.001||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745560|NCT00402987|3208396|Superiority or Other||Odds Ratio (OR)|1.12||||0.814||95.0|0.4|2.8||Treatment as a factor|Regression, Logistic||||
1745350|NCT00402987|3208381|Superiority or Other||||||<|0.083||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745351|NCT00402987|3208381|Superiority or Other||||||<|0.089||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745352|NCT00402987|3208381|Superiority or Other||||||<|0.762||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745353|NCT00402987|3208381|Superiority or Other||||||<|0.069||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745354|NCT00402987|3208381|Superiority or Other||||||<|0.001||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745355|NCT00402987|3208381|Superiority or Other||||||<|0.001||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745356|NCT00402987|3208381|Superiority or Other||||||<|0.059||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745357|NCT00402987|3208381|Superiority or Other||||||<|0.075||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745358|NCT00402987|3208381|Superiority or Other||||||<|0.689||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745359|NCT00402987|3208381|Superiority or Other||||||<|0.07||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745360|NCT00402987|3208381|Superiority or Other||||||<|0.001||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745361|NCT00402987|3208381|Superiority or Other||||||<|0.001||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745362|NCT00402987|3208381|Superiority or Other||||||<|0.042||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745363|NCT00402987|3208381|Superiority or Other||||||<|0.065||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745364|NCT00402987|3208381|Superiority or Other||||||<|0.609||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745365|NCT00402987|3208381|Superiority or Other||||||<|0.071||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745366|NCT00402987|3208381|Superiority or Other||||||<|0.001||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745367|NCT00402987|3208381|Superiority or Other||||||<|0.001||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745368|NCT00402987|3208381|Superiority or Other||||||<|0.027||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745369|NCT00402987|3208381|Superiority or Other||||||<|0.05||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745370|NCT00402987|3208381|Superiority or Other||||||<|0.552||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745371|NCT00402987|3208381|Superiority or Other||||||<|0.081||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745372|NCT00402987|3208381|Superiority or Other||||||<|0.001||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745373|NCT00402987|3208381|Superiority or Other||||||<|0.001||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745374|NCT00402987|3208381|Superiority or Other||||||<|0.019||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745375|NCT00402987|3208381|Superiority or Other||||||<|0.038||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745376|NCT00402987|3208381|Superiority or Other||||||<|0.518||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745377|NCT00402987|3208381|Superiority or Other||||||<|0.09||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745378|NCT00402987|3208381|Superiority or Other||||||<|0.001||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745379|NCT00402987|3208381|Superiority or Other||||||<|0.001||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745380|NCT00402987|3208382|Superiority or Other|||||||0.336||||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745381|NCT00402987|3208382|Superiority or Other||||||<|0.001||||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745382|NCT00402987|3208382|Superiority or Other||||||<|0.001||||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745383|NCT00402987|3208382|Superiority or Other||||||<|0.244||||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745384|NCT00402987|3208382|Superiority or Other||||||<|0.001||||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745385|NCT00402987|3208382|Superiority or Other||||||<|0.001||||||Analysis at 5 hours Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745386|NCT00402987|3208382|Superiority or Other||||||<|0.164||||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745387|NCT00402987|3208382|Superiority or Other||||||<|0.001||||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745388|NCT00402987|3208382|Superiority or Other||||||<|0.001||||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745389|NCT00402987|3208382|Superiority or Other||||||<|0.122||||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745390|NCT00402987|3208382|Superiority or Other||||||<|0.001||||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745391|NCT00402987|3208382|Superiority or Other||||||<|0.001||||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745392|NCT00402987|3208382|Superiority or Other||||||<|0.127||||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745393|NCT00402987|3208382|Superiority or Other||||||<|0.009||||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745394|NCT00402987|3208382|Superiority or Other||||||<|0.001||||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745395|NCT00402987|3208382|Superiority or Other||||||<|0.148||||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745396|NCT00402987|3208382|Superiority or Other||||||<|0.02||||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745397|NCT00402987|3208382|Superiority or Other||||||<|0.001||||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745398|NCT00402987|3208382|Superiority or Other||||||<|0.194||||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745399|NCT00402987|3208382|Superiority or Other||||||<|0.044||||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745400|NCT00402987|3208382|Superiority or Other||||||<|0.001||||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745401|NCT00402987|3208382|Superiority or Other||||||<|0.262||||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1749078|NCT00363415|3213900|Superiority or Other||||||<|0.001||||||P-value for Sex: Male|Log Rank||||
1745402|NCT00402987|3208382|Superiority or Other||||||<|0.09||||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745403|NCT00402987|3208382|Superiority or Other||||||<|0.005||||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745404|NCT00402987|3208382|Superiority or Other||||||<|0.354||||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745405|NCT00402987|3208382|Superiority or Other||||||<|0.171||||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745406|NCT00402987|3208382|Superiority or Other||||||<|0.022||||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745407|NCT00402987|3208382|Superiority or Other||||||<|0.421||||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745408|NCT00402987|3208382|Superiority or Other||||||<|0.284||||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745409|NCT00402987|3208382|Superiority or Other||||||<|0.062||||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745410|NCT00402987|3208382|Superiority or Other||||||<|0.469||||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745411|NCT00402987|3208382|Superiority or Other||||||<|0.479||||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745412|NCT00402987|3208382|Superiority or Other||||||<|0.153||||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745413|NCT00402987|3208382|Superiority or Other||||||<|0.667||||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745414|NCT00402987|3208382|Superiority or Other||||||<|0.78||||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745415|NCT00402987|3208382|Superiority or Other||||||<|0.48||||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745416|NCT00402987|3208383|Superiority or Other||Mean Difference (Final Values)|-5.9||||0.127||95.0|-13.5|1.7||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745417|NCT00402987|3208383|Superiority or Other||Mean Difference (Final Values)|10.2||||0.009||95.0|2.6|17.9||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745418|NCT00402987|3208383|Superiority or Other||Mean Difference (Final Values)|16.2|||<|0.001||95.0|8.5|23.8||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745419|NCT00402987|3208384|Superiority or Other|||||||0.5||||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745420|NCT00402987|3208384|Superiority or Other|||||||0.036||||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745421|NCT00402987|3208384|Superiority or Other|||||||0.033||||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745422|NCT00402987|3208384|Superiority or Other|||||||0.015||||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745423|NCT00402987|3208384|Superiority or Other|||||||0.007||||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745424|NCT00402987|3208384|Superiority or Other|||||||0.002||||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745425|NCT00402987|3208384|Superiority or Other|||||||0.001||||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745426|NCT00402987|3208385|Superiority or Other|||||||0.001||||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745427|NCT00402987|3208385|Superiority or Other||||||<|0.001||||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745428|NCT00402987|3208385|Superiority or Other||||||<|0.001||||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745430|NCT00402987|3208385|Superiority or Other||||||<|0.001||||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745431|NCT00402987|3208385|Superiority or Other||||||<|0.001||||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745432|NCT00402987|3208385|Superiority or Other||||||<|0.001||||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745433|NCT00402987|3208385|Superiority or Other||||||<|0.001||||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745434|NCT00402987|3208385|Superiority or Other||||||<|0.005||||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745435|NCT00402987|3208385|Superiority or Other||||||<|0.114||||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745436|NCT00402987|3208385|Superiority or Other||||||<|0.094||||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745437|NCT00402987|3208385|Superiority or Other||||||<|0.775||||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745438|NCT00402987|3208386|Superiority or Other|||||||0.948||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745439|NCT00402987|3208386|Superiority or Other|||||||0.952||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745440|NCT00402987|3208386|Superiority or Other|||||||0.892||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745441|NCT00402987|3208386|Superiority or Other|||||||0.023||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745442|NCT00402987|3208386|Superiority or Other|||||||0.029||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745443|NCT00402987|3208386|Superiority or Other|||||||0.005||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745444|NCT00402987|3208386|Superiority or Other|||||||0.343||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745445|NCT00402987|3208386|Superiority or Other|||||||0.394||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745446|NCT00402987|3208386|Superiority or Other|||||||0.808||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745447|NCT00402987|3208386|Superiority or Other|||||||0.016||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745448|NCT00402987|3208386|Superiority or Other|||||||0.001||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745449|NCT00402987|3208386|Superiority or Other||||||<|0.001||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745450|NCT00402987|3208386|Superiority or Other||||||<|0.256||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745451|NCT00402987|3208386|Superiority or Other||||||<|0.326||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745452|NCT00402987|3208386|Superiority or Other||||||<|0.741||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745453|NCT00402987|3208386|Superiority or Other||||||<|0.018||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745454|NCT00402987|3208386|Superiority or Other||||||<|0.001||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745455|NCT00402987|3208386|Superiority or Other||||||<|0.001||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745456|NCT00402987|3208386|Superiority or Other||||||<|0.191||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745724|NCT00402363|3208471|Superiority or Other||Hazard Ratio (HR)|1.12||||0.331|2-Sided|95.0|0.89|1.4|||Regression, Cox||||
1745457|NCT00402987|3208386|Superiority or Other||||||<|0.287||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745458|NCT00402987|3208386|Superiority or Other||||||<|0.653||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745459|NCT00402987|3208386|Superiority or Other||||||<|0.018||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745460|NCT00402987|3208386|Superiority or Other||||||<|0.001||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745461|NCT00402987|3208386|Superiority or Other||||||<|0.001||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745462|NCT00402987|3208386|Superiority or Other||||||<|0.136||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745463|NCT00402987|3208386|Superiority or Other||||||<|0.252||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745464|NCT00402987|3208386|Superiority or Other||||||<|0.561||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745465|NCT00402987|3208386|Superiority or Other||||||<|0.018||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745466|NCT00402987|3208386|Superiority or Other||||||<|0.001||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745467|NCT00402987|3208386|Superiority or Other||||||<|0.001||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745468|NCT00402987|3208386|Superiority or Other||||||<|0.086||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745469|NCT00402987|3208386|Superiority or Other||||||<|0.197||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745470|NCT00402987|3208386|Superiority or Other||||||<|0.484||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745471|NCT00402987|3208386|Superiority or Other||||||<|0.02||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745472|NCT00402987|3208386|Superiority or Other||||||<|0.001||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745473|NCT00402987|3208386|Superiority or Other||||||<|0.001||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745474|NCT00402987|3208386|Superiority or Other||||||<|0.053||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745475|NCT00402987|3208386|Superiority or Other||||||<|0.131||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745476|NCT00402987|3208386|Superiority or Other||||||<|0.463||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745477|NCT00402987|3208386|Superiority or Other||||||<|0.026||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745478|NCT00402987|3208386|Superiority or Other||||||<|0.001||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745479|NCT00402987|3208386|Superiority or Other||||||<|0.001||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745480|NCT00402987|3208387|Superiority or Other|||||||0.512||||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745481|NCT00402987|3208387|Superiority or Other||||||<|0.001||||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745482|NCT00402987|3208387|Superiority or Other||||||<|0.001||||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1749490|NCT00360568|3214229|Superiority or Other|||||||0.766|||||||t-test, 2 sided||||
1745483|NCT00402987|3208387|Superiority or Other||||||<|0.393||||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745484|NCT00402987|3208387|Superiority or Other||||||<|0.001||||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745485|NCT00402987|3208387|Superiority or Other||||||<|0.001||||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745486|NCT00402987|3208387|Superiority or Other||||||<|0.259||||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745487|NCT00402987|3208387|Superiority or Other||||||<|0.001||||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745488|NCT00402987|3208387|Superiority or Other||||||<|0.001||||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745489|NCT00402987|3208387|Superiority or Other||||||<|0.179||||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745490|NCT00402987|3208387|Superiority or Other||||||<|0.001||||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745491|NCT00402987|3208387|Superiority or Other||||||<|0.001||||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745492|NCT00402987|3208387|Superiority or Other||||||<|0.186||||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745493|NCT00402987|3208387|Superiority or Other||||||<|0.002||||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745494|NCT00402987|3208387|Superiority or Other||||||<|0.001||||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745495|NCT00402987|3208387|Superiority or Other||||||<|0.205||||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745496|NCT00402987|3208387|Superiority or Other||||||<|0.006||||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745497|NCT00402987|3208387|Superiority or Other||||||<|0.001||||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745498|NCT00402987|3208387|Superiority or Other||||||<|0.249||||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745499|NCT00402987|3208387|Superiority or Other||||||<|0.022||||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745500|NCT00402987|3208387|Superiority or Other||||||<|0.001||||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745501|NCT00402987|3208387|Superiority or Other||||||<|0.344||||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745502|NCT00402987|3208387|Superiority or Other||||||<|0.07||||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745503|NCT00402987|3208387|Superiority or Other||||||<|0.006||||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745504|NCT00402987|3208387|Superiority or Other||||||<|0.521||||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745505|NCT00402987|3208387|Superiority or Other||||||<|0.154||||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745506|NCT00402987|3208387|Superiority or Other||||||<|0.039||||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745507|NCT00402987|3208387|Superiority or Other||||||<|0.693||||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745508|NCT00402987|3208387|Superiority or Other||||||<|0.344||||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1749491|NCT00360568|3214230|Superiority or Other|||||||0.055|||||||t-test, 2 sided||||
1745509|NCT00402987|3208387|Superiority or Other||||||<|0.18||||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745510|NCT00402987|3208387|Superiority or Other||||||<|0.82||||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745511|NCT00402987|3208387|Superiority or Other||||||<|0.69||||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745512|NCT00402987|3208387|Superiority or Other||||||<|0.532||||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745513|NCT00402987|3208387|Superiority or Other||||||<|0.975||||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745514|NCT00402987|3208387|Superiority or Other||||||<|0.985||||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745515|NCT00402987|3208387|Superiority or Other||||||<|0.961||||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745516|NCT00402987|3208388|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.186||95.0|-1.0|0.2||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745517|NCT00402987|3208388|Superiority or Other||Mean Difference (Final Values)|0.9||||0.002||95.0|0.4|1.5||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745518|NCT00402987|3208388|Superiority or Other||Mean Difference (Final Values)|1.3|||<|0.001||95.0|0.8|1.9||Pairwise comparison. No adjustment made for multiplicity.|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745519|NCT00402987|3208389|Superiority or Other|||||||0.482||||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745520|NCT00402987|3208389|Superiority or Other|||||||0.066||||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745521|NCT00402987|3208389|Superiority or Other|||||||0.029||||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745522|NCT00402987|3208389|Superiority or Other|||||||0.032||||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745523|NCT00402987|3208389|Superiority or Other|||||||0.043||||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745524|NCT00402987|3208389|Superiority or Other|||||||0.009||||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745525|NCT00402987|3208389|Superiority or Other|||||||0.003||||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745526|NCT00402987|3208390|Superiority or Other|||||||0.001||||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745527|NCT00402987|3208390|Superiority or Other||||||<|0.001||||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745528|NCT00402987|3208390|Superiority or Other||||||<|0.001||||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745529|NCT00402987|3208390|Superiority or Other||||||<|0.001||||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745530|NCT00402987|3208390|Superiority or Other||||||<|0.001||||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Continuous data were analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745531|NCT00402987|3208390|Superiority or Other||||||<|0.001||||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745532|NCT00402987|3208390|Superiority or Other||||||<|0.001||||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745533|NCT00402987|3208390|Superiority or Other||||||<|0.001||||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745534|NCT00402987|3208390|Superiority or Other||||||<|0.008||||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745535|NCT00402987|3208390|Superiority or Other||||||<|0.076||||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745536|NCT00402987|3208390|Superiority or Other||||||<|0.609||||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1749492|NCT00360568|3214231|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1745537|NCT00402987|3208390|Superiority or Other||||||<|0.999||||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745538|NCT00402987|3208391|Superiority or Other|||||||0.747||||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745539|NCT00402987|3208391|Superiority or Other|||||||0.958||||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745540|NCT00402987|3208391|Superiority or Other|||||||0.748||||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745541|NCT00402987|3208391|Superiority or Other|||||||0.015||||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745542|NCT00402987|3208391|Superiority or Other|||||||0.013||||||"Analysis at 24 hours~Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745543|NCT00402987|3208391|Superiority or Other|||||||0.002||||||"Analysis at 24 hours~Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745544|NCT00402987|3208391|Superiority or Other|||||||0.438||||||"Analysis at 12 hours~Overall test of Celecoxib 100mg/Placebo versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745545|NCT00402987|3208391|Superiority or Other|||||||0.93||||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745546|NCT00402987|3208391|Superiority or Other|||||||0.411||||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg/50mg that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745547|NCT00402987|3208391|Superiority or Other|||||||0.015||||||Analysis at 12 hours Overall test of Celecoxib 100mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745548|NCT00402987|3208391|Superiority or Other|||||||0.002||||||"Analysis at 12 hours~Overall test of Celecoxib 100mg/Placebo versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745549|NCT00402987|3208391|Superiority or Other||||||<|0.001||||||"Analysis at 12 hours~Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor)."|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745550|NCT00402987|3208392|Superiority or Other|||||||0.889||||||Overall test of Celecoxib 50mg/50mg versus Celecoxib 100mg (pooled) that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745551|NCT00402987|3208392|Superiority or Other||||||<|0.001||||||Overall test of Celecoxib 100mg (pooled) versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745552|NCT00402987|3208392|Superiority or Other||||||<|0.001||||||Overall test of Celecoxib 50mg/50mg versus Placebo that takes into account the ordered data (categories: excellent, good, fair, poor).|Mantel Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1745553|NCT00402987|3208393|Superiority or Other||||||<|0.05||||||p-value for distribution of time to onset of analgesia|Log Rank|||For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hours|
1745554|NCT00402987|3208393|Superiority or Other||||||<|0.05||||||p-value for distribution of time to onset of analgesia|Log Rank|||For subjects who did not experience onset of analgesia within 2 hours post-first dose, the time to onset of analgesia was censored at 2 hours|
1745555|NCT00402987|3208394|Superiority or Other||||||<|0.05||||||p-value for distribution of time to meaningful pain relief|Log Rank|||For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours|
1745556|NCT00402987|3208394|Superiority or Other||||||<|0.05||||||p-value for distribution of time to meaningful pain relief|Log Rank|||For subjects who did not experience meaningful pain relief within 2 hours post-first dose, the time to meaningful pain relief was censored at 2 hours.|
1745557|NCT00402987|3208395|Superiority or Other||||||<|0.05||||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours|
1745558|NCT00402987|3208395|Superiority or Other||||||<|0.05||||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours|
1745559|NCT00402987|3208395|Superiority or Other||||||<|0.05||||||p-value for distribution of time to perceptible pain relief|Log Rank|||For subjects who did not experience perceptible pain relief within 2 hours post-first dose, the time to perceptible pain relief was censored at 2 hours|
1745561|NCT00402987|3208396|Superiority or Other||Odds Ratio (OR)|0.75||||0.484||95.0|0.3|1.7||Treatment as a factor|Regression, Logistic||||
1745562|NCT00402987|3208396|Superiority or Other||Odds Ratio (OR)|0.84||||0.671||95.0|0.4|1.9||Treatment as a factor|Regression, Logistic||||
1745563|NCT00402987|3208396|Superiority or Other||Odds Ratio (OR)|1.95||||0.134||95.0|0.8|4.7||Treatment as a factor|Regression, Logistic||||
1745564|NCT00402987|3208396|Superiority or Other||Odds Ratio (OR)|2.18||||0.077||95.0|0.9|5.1||Treatment as a factor|Regression, Logistic||||
1745565|NCT00402987|3208396|Superiority or Other||Odds Ratio (OR)|1.63||||0.202||95.0|0.8|3.5||Treatment as a factor|Regression, Logistic||||
1745566|NCT00402987|3208397|Superiority or Other||Odds Ratio (OR)|1.16||||0.634||95.0|0.6|2.2||Treatment as a factor|Regression, Logistic||||
1745567|NCT00402987|3208397|Superiority or Other||Odds Ratio (OR)|3.07||||0.003||95.0|1.5|6.4||Treatment as a factor|Regression, Logistic||||
1745568|NCT00402987|3208397|Superiority or Other||Odds Ratio (OR)|2.64||||0.01||95.0|1.3|5.5||Treatment as a factor|Regression, Logistic||||
1745569|NCT00402987|3208398|Superiority or Other|||||||0.537||||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745570|NCT00402987|3208398|Superiority or Other|||||||0.226||||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745571|NCT00402987|3208398|Superiority or Other|||||||0.111||||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745572|NCT00402987|3208398|Superiority or Other|||||||0.046||||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745573|NCT00402987|3208398|Superiority or Other|||||||0.046||||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745574|NCT00402987|3208398|Superiority or Other|||||||0.005||||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745575|NCT00402987|3208398|Superiority or Other|||||||0.001||||||"Analysis at 7 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745576|NCT00402987|3208399|Superiority or Other||||||<|0.001||||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745577|NCT00402987|3208399|Superiority or Other||||||<|0.001||||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745578|NCT00402987|3208399|Superiority or Other||||||<|0.001||||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745579|NCT00402987|3208399|Superiority or Other||||||<|0.001||||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745580|NCT00402987|3208399|Superiority or Other||||||<|0.001||||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745581|NCT00402987|3208399|Superiority or Other||||||<|0.001||||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745582|NCT00402987|3208399|Superiority or Other||||||<|0.001||||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745583|NCT00402987|3208399|Superiority or Other||||||<|0.001||||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745584|NCT00402987|3208399|Superiority or Other||||||<|0.003||||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745585|NCT00402987|3208399|Superiority or Other||||||<|0.203||||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745586|NCT00402987|3208399|Superiority or Other||||||<|0.697||||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745587|NCT00402987|3208399|Superiority or Other||||||<|0.537||||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745588|NCT00402987|3208400|Superiority or Other||||||<|0.001||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745589|NCT00402987|3208400|Superiority or Other||||||<|0.919||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745590|NCT00402987|3208400|Superiority or Other||||||<|0.383||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745591|NCT00402987|3208400|Superiority or Other||||||<|0.297||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745592|NCT00402987|3208400|Superiority or Other||||||<|0.239||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745593|NCT00402987|3208400|Superiority or Other||||||<|0.188||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745594|NCT00402987|3208400|Superiority or Other||||||<|0.14||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745595|NCT00402987|3208400|Superiority or Other||||||<|0.106||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745596|NCT00402987|3208400|Superiority or Other||||||<|0.708||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745597|NCT00402987|3208400|Superiority or Other||||||<|0.244||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745598|NCT00402987|3208400|Superiority or Other||||||<|0.197||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745599|NCT00402987|3208400|Superiority or Other||||||<|0.171||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745600|NCT00402987|3208400|Superiority or Other||||||<|0.152||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745601|NCT00402987|3208400|Superiority or Other||||||<|0.117||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745602|NCT00402987|3208400|Superiority or Other||||||<|0.081||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745603|NCT00402987|3208400|Superiority or Other||||||<|0.622||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745604|NCT00402987|3208400|Superiority or Other||||||<|0.876||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745605|NCT00402987|3208400|Superiority or Other||||||<|0.933||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745606|NCT00402987|3208400|Superiority or Other||||||<|0.994||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745607|NCT00402987|3208400|Superiority or Other||||||<|0.929||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745608|NCT00402987|3208400|Superiority or Other||||||<|0.891||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745609|NCT00402987|3208400|Superiority or Other||||||<|0.904||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745610|NCT00402987|3208400|Superiority or Other||||||<|0.012||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745611|NCT00402987|3208400|Superiority or Other||||||<|0.008||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745612|NCT00402987|3208400|Superiority or Other||||||<|0.008||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745613|NCT00402987|3208400|Superiority or Other||||||<|0.008||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745614|NCT00402987|3208400|Superiority or Other||||||<|0.008||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745615|NCT00402987|3208400|Superiority or Other||||||<|0.009||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745616|NCT00402987|3208400|Superiority or Other||||||<|0.011||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745617|NCT00402987|3208400|Superiority or Other||||||<|0.017||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745618|NCT00402987|3208400|Superiority or Other||||||<|0.001||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1749493|NCT00360568|3214232|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1745619|NCT00402987|3208400|Superiority or Other||||||<|0.001||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745620|NCT00402987|3208400|Superiority or Other||||||<|0.001||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745621|NCT00402987|3208400|Superiority or Other||||||<|0.001||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745622|NCT00402987|3208400|Superiority or Other||||||<|0.001||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745623|NCT00402987|3208400|Superiority or Other||||||<|0.001||||||"Analysis at 24 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745624|NCT00402987|3208400|Superiority or Other||||||<|0.001||||||"Analysis at 12 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745625|NCT00402987|3208400|Superiority or Other||||||<|0.001||||||"Analysis at 11 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745626|NCT00402987|3208400|Superiority or Other||||||<|0.001||||||"Analysis at 10 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745627|NCT00402987|3208400|Superiority or Other||||||<|0.001||||||"Analysis at 9 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745628|NCT00402987|3208400|Superiority or Other||||||<|0.001||||||"Analysis at 8 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745629|NCT00402987|3208400|Superiority or Other||||||<|0.001||||||"Analysis at 7 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745630|NCT00402987|3208401|Superiority or Other|||||||0.259||||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745631|NCT00402987|3208401|Superiority or Other|||||||0.183||||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745632|NCT00402987|3208401|Superiority or Other|||||||0.111||||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745633|NCT00402987|3208401|Superiority or Other|||||||0.086||||||"Analyaia at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745634|NCT00402987|3208401|Superiority or Other|||||||0.113||||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745635|NCT00402987|3208401|Superiority or Other|||||||0.146||||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745636|NCT00402987|3208401|Superiority or Other|||||||0.237||||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745637|NCT00402987|3208401|Superiority or Other|||||||0.419||||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745638|NCT00402987|3208401|Superiority or Other|||||||0.561||||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745639|NCT00402987|3208401|Superiority or Other|||||||0.775||||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745640|NCT00402987|3208401|Superiority or Other|||||||0.759||||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745641|NCT00402987|3208401|Superiority or Other|||||||0.741||||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745642|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745643|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745644|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1749494|NCT00360568|3214233|Superiority or Other|||||||0.394|||||||t-test, 2 sided||||
1745645|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745646|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745647|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745648|NCT00402987|3208401|Superiority or Other||||||<|0.002||||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745649|NCT00402987|3208401|Superiority or Other||||||<|0.005||||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745650|NCT00402987|3208401|Superiority or Other||||||<|0.01||||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745651|NCT00402987|3208401|Superiority or Other||||||<|0.022||||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745652|NCT00402987|3208401|Superiority or Other||||||<|0.034||||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745653|NCT00402987|3208401|Superiority or Other||||||<|0.096||||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745654|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 6 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745655|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 5 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745656|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 4 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745657|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 3 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745658|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 2 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745659|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 1.75 hours~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745660|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 90 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745661|NCT00402987|3208401|Superiority or Other||||||<|0.001||||||"Analysis at 75 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745662|NCT00402987|3208401|Superiority or Other||||||<|0.002||||||"Analysis at 60 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745663|NCT00402987|3208401|Superiority or Other||||||<|0.01||||||"Analysis at 45 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745664|NCT00402987|3208401|Superiority or Other||||||<|0.069||||||"Analysis at 30 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745665|NCT00402987|3208401|Superiority or Other||||||<|0.18||||||"Analysis at 15 min~Pairwise comparison. No adjustment made for multiplicity."|Generalized Linear Model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745666|NCT00402987|3208402|Superiority or Other|||||||0.365||||||"Analysis at 24 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745667|NCT00402987|3208402|Superiority or Other|||||||0.012||||||"Analysis at 12 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745668|NCT00402987|3208402|Superiority or Other|||||||0.014||||||"Analysis at 11 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745669|NCT00402987|3208402|Superiority or Other|||||||0.007||||||"Analysis at 10 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745670|NCT00402987|3208402|Superiority or Other|||||||0.006||||||"Analysis at 9 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745671|NCT00402987|3208402|Superiority or Other||||||<|0.001||||||"Analysis at 8 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745672|NCT00402987|3208402|Superiority or Other||||||<|0.001||||||"Analysis at 7 hours~Overall P-value"|Generalized Linear Model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745673|NCT00402987|3208403|Superiority or Other||||||<|0.001||||||"Analysis at 6 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745674|NCT00402987|3208403|Superiority or Other||||||<|0.001||||||"Analysis at 5 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745675|NCT00402987|3208403|Superiority or Other||||||<|0.001||||||"Analysis at 4 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745676|NCT00402987|3208403|Superiority or Other||||||<|0.001||||||"Analysis at 3 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745677|NCT00402987|3208403|Superiority or Other||||||<|0.001||||||"Analysis at 2 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745678|NCT00402987|3208403|Superiority or Other||||||<|0.001||||||"Analysis at 1.75 hours~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745679|NCT00402987|3208403|Superiority or Other||||||<|0.001||||||"Analysis at 90 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745680|NCT00402987|3208403|Superiority or Other||||||<|0.001||||||"Analysis at 75 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745681|NCT00402987|3208403|Superiority or Other||||||<|0.002||||||"Analysis at 60 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745682|NCT00402987|3208403|Superiority or Other||||||<|0.005||||||"Analysis at 45 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745683|NCT00402987|3208403|Superiority or Other||||||<|0.056||||||"Analysis at 30 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745684|NCT00402987|3208403|Superiority or Other||||||<|0.212||||||"Analysis at 15 min~Overall P-value"|Generalized linear model|Analyzed using a Generalized Linear Model with treatment as fixed effect and baseline score as a covariate|||
1745685|NCT00402987|3208404|Superiority or Other||Mean Difference (Final Values)|11.7||||0.0003||95.0|5.5|17.9|||generalized linear model|p-value was calculated using Generalized Linear Model with treatment as fixed effect and baseline score as a covariate||Null hypothesis: No difference in SPID2 (PI-VAS) at two hours between celecoxib 100 mg and placebo. Sample size was based on an expected effect size of 0.42 (from earlier studies), 80% power and an alpha of 0.05.|
1745686|NCT00402831|3208421|Non-Inferiority or Equivalence|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.7|||||2-Sided|95.0|-2.1|4.1||||||Varicella|
1745687|NCT00402831|3208421|Non-Inferiority or Equivalence|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.7|||||2-Sided|95.0|-2.3|4.1||||||Rubella difference|
1745688|NCT00402831|3208421|Non-Inferiority or Equivalence|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.1|||||2-Sided|95.0|-3.0|3.3||||||Mumps difference|
1745689|NCT00402831|3208421|Non-Inferiority or Equivalence|Noninferiority was declared when the lower bounds of the 95% confidence interval (CI) of the group difference in response rates was greater than -10%.|Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-2.5|2.6||||||Measles difference|
1745690|NCT00402727|3208428|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-2.9||||||95.0|-9.3|2.2|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.|
1745691|NCT00402727|3208429|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-0.1||||||95.0|-6.9|5.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.|
1745692|NCT00402727|3208430|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-5.6||||||95.0|-11.4|-0.8|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.|
1745693|NCT00402727|3208431|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-3.9||||||95.0|-9.5|1.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.|
1745694|NCT00402727|3208432|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-8.6||||||95.0|-17.6|-0.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.|
1745695|NCT00402727|3208433|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference of eradication rates (in %)|-8.5||||||95.0|-17.0|-1.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.|
1745696|NCT00402727|3208434|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference of resolution rates (in %)|1.6||||||95.0|-2.4|5.3|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.|
1745697|NCT00402727|3208435|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference of resolution rates (in %)|0.2||||||95.0|-3.1|2.4|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.|
1745698|NCT00402727|3208436|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference of improvement rates (in %)|1.4||||||95.0|-1.3|3.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.|
1745699|NCT00402727|3208437|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference of improvement rates (in %)|-0.7||||||95.0|-1.6|0.6|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.|
1745700|NCT00402727|3208438|Non-Inferiority or Equivalence|Sample size estimation was based on the primary efficacy variable.|Difference of cure rates (in percent)|1.3||||||95.0|-3.8|6.3|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.|
1745701|NCT00402727|3208439|Non-Inferiority or Equivalence|The non-inferiority margin was set to 10% in the protocol, in agreeance with FDA recommendations. Sample size was estimated using the method as described in Farrington-Manning. Estimation was performed to achieve 85% power, based on the equivalence delta of 10%, and a clinical success rate of 80% in the per protocol population|Difference of cure rates (in percent)|-1.0||||||95.0|-5.3|3.9|||||A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group.|Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al.|
1745702|NCT00402688|3208447|Non-Inferiority or Equivalence|Non-inferiority margin is a risk difference of 0.2.|Risk Difference (RD)|0.045||||||95.0|-0.106|0.195|||||Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 3 weeks).||
1745703|NCT00402688|3208447|Non-Inferiority or Equivalence|Non-inferiority margin is a risk difference of 0.2.|Risk Difference (RD)|0.063||||||95.0|-0.089|0.215|||||Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 2 weeks ).||
1745704|NCT00402363|3208461|Superiority or Other||median difference (Hodges-Lehmann)|0.2||||0.094|2-Sided|95.0|-0.08|2.11|||non-parametric ANCOVA||||
1745705|NCT00402363|3208461|Superiority or Other||median difference (Hodges-Lehmann)|0.249||||0.152|2-Sided|95.0|-0.09|4.31|||Wilcoxon (Mann-Whitney)||||
1745706|NCT00402363|3208461|Superiority or Other||median difference (Hodges-Lehmann)|0.242||||0.239|2-Sided|95.0|-0.19|2.17|||non-parametric ANCOVA||||
1745707|NCT00402363|3208462|Superiority or Other||median difference (Hodges-Lehmann)|0.181||||0.097|2-Sided|95.0|-0.1|2.1|||non-parametric ANCOVA||||
1745708|NCT00402363|3208462|Superiority or Other||median difference (Hodges-Lehmann)|0.216||||0.188|2-Sided|95.0|-0.14|3.14|||Wilcoxon (Mann-Whitney)||||
1745709|NCT00402363|3208462|Superiority or Other||median difference (Hodges-Lehmann)|0.321||||0.218|2-Sided|95.0|-0.18|2.21|||non-parametric ANCOVA||||
1745710|NCT00402363|3208463|Superiority or Other||median difference (Hodges-Lehmann)|0.039||||0.218|2-Sided|95.0|-0.06|1.49|||non-parametric ANCOVA||||
1745711|NCT00402363|3208463|Superiority or Other||median difference (Hodges-Lehmann)|0.063||||0.479|2-Sided|95.0|-0.08|2.02|||Wilcoxon (Mann-Whitney)||||
1745712|NCT00402363|3208463|Superiority or Other||median difference (Hodges-Lehmann)|0.07||||0.29|2-Sided|95.0|-0.09|2.08|||non-parametric ANCOVA||||
1745713|NCT00402363|3208464|Superiority or Other||Hazard Ratio (HR)|1.2||||0.188|2-Sided|95.0|0.92|1.57|||Regression, Cox||||
1745714|NCT00402363|3208465|Superiority or Other||Hazard Ratio (HR)|1.51||||0.206|2-Sided|95.0|0.79|2.86|||Log Rank||||
1745715|NCT00402363|3208465|Superiority or Other||Hazard Ratio (HR)|1.12||||0.461|2-Sided|95.0|0.83|1.51|||Regression, Cox||||
1745716|NCT00402363|3208466|Superiority or Other||Hazard Ratio (HR)|1.2||||0.185|2-Sided|95.0|0.92|1.56|||Regression, Cox||||
1745717|NCT00402363|3208467|Superiority or Other||Hazard Ratio (HR)|1.68||||0.103|2-Sided|95.0|0.89|3.15|||Log Rank||||
1745718|NCT00402363|3208467|Superiority or Other||Hazard Ratio (HR)|1.09||||0.565|2-Sided|95.0|0.81|1.47|||Regression, Cox||||
1745719|NCT00402363|3208468|Superiority or Other||Hazard Ratio (HR)|1.16||||0.167|2-Sided|95.0|0.94|1.42|||Regression, Cox||||
1745720|NCT00402363|3208469|Superiority or Other||Hazard Ratio (HR)|1.19||||0.486|2-Sided|95.0|0.73|1.95|||Log Rank||||
1745721|NCT00402363|3208469|Superiority or Other||Hazard Ratio (HR)|1.14||||0.27|2-Sided|95.0|0.9|1.43|||Regression, Cox||||
1745722|NCT00402363|3208470|Superiority or Other||Hazard Ratio (HR)|1.16||||0.168|2-Sided|95.0|0.94|1.42|||Regression, Cox||||
1745723|NCT00402363|3208471|Superiority or Other||Hazard Ratio (HR)|1.29||||0.297|2-Sided|95.0|0.79|2.11|||Log Rank||||
1745725|NCT00402363|3208472|Superiority or Other||Hazard Ratio (HR)|1.22||||0.082|2-Sided|95.0|0.98|1.53|||Regression, Cox||||
1745726|NCT00402363|3208473|Superiority or Other||Hazard Ratio (HR)|1.5||||0.171|2-Sided|95.0|0.83|2.69|||Log Rank||||
1745727|NCT00402363|3208473|Superiority or Other||Hazard Ratio (HR)|1.17||||0.213|2-Sided|95.0|0.91|1.49|||Regression, Cox||||
1745728|NCT00402363|3208474|Superiority or Other||Hazard Ratio (HR)|1.22||||0.081|2-Sided|95.0|0.98|1.52|||Regression, Cox||||
1745729|NCT00402363|3208474|Superiority or Other||Hazard Ratio (HR)|1.64||||0.089|2-Sided|95.0|0.92|2.92|||Log Rank||||
1745730|NCT00402363|3208475|Superiority or Other||Hazard Ratio (HR)|1.15||||0.263|2-Sided|95.0|0.9|1.46|||Regression, Cox||||
1745731|NCT00402337|3208481|Superiority or Other||||||<|0.0001|||||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.|
1745732|NCT00402337|3208481|Superiority or Other||||||<|0.0001|||||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.|
1745733|NCT00402337|3208481|Superiority or Other||||||<|0.001|||||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.|
1745734|NCT00402337|3208481|Superiority or Other||||||<|0.0337|||||||ANCOVA|||The null hypothesis is that the active treatment group is equal to the placebo group.|
1745735|NCT00402324|3208482|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1745736|NCT00402324|3208483|Superiority or Other||||||<|0.001|||||||ANCOVA|Type III sums of squares of ANCOVA model: Change= Treatment + Pooled Investigator + Baseline|||
1745737|NCT00402324|3208484|Superiority or Other||||||<|0.001|||||||ANCOVA|Type III sums of squares of ANCOVA model: Change= Treatment + Pooled Investigator + Baseline|||
1745738|NCT00402324|3208485|Superiority or Other|||||||0.046||||||P-value for Bilirubin Total Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator|||
1745739|NCT00402324|3208486|Superiority or Other|||||||0.007||||||P-value for Fasting Blood Glucose Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator|||
1745740|NCT00402324|3208487|Superiority or Other|||||||0.293||||||P-value for Fasting Triglycerides Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator|||
1745741|NCT00402324|3208488|Superiority or Other|||||||0.122||||||P-value for High Density Lipoprotein Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator|||
1745742|NCT00402324|3208488|Superiority or Other|||||||0.924||||||P-value for Low Density Lipoprotein Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator|||
1745743|NCT00402324|3208488|Superiority or Other|||||||0.657||||||P-value for Total Cholesterol Change from Baseline|ANOVA|Type III sums of squares of ANOVA model: Ranked Change= Treatment + Pooled Investigator|||
1745744|NCT00402324|3208490|Superiority or Other|||||||0.056|||||||ANCOVA|Type III sums of squares of ANCOVA model: Change= TRT + Pooled Investigator + Baseline.|||
1745745|NCT00402324|3208491|Superiority or Other|||||||0.048|||||||Fisher Exact||||
1745746|NCT00402324|3208492|Superiority or Other|||||||0.1|||||||Fisher Exact||||
1745747|NCT00402324|3208493|Superiority or Other|||||||0.022||||||All tests of treatment effects will be conducted at a two-sided alpha level of 0.05 unless otherwise stated.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Change = Therapy PooledINV Visit Baseline Baseline*Visit Therapy*Visit. P-value from therapy term in model.||The overall power of the two co-primary analyses—the probability of simultaneously rejecting both co-primary null hypotheses—for this sample size under assumed effect sizes of 0.5 and 0.45 is estimated as approximately 85-87% and 77-80%, respectively.|
1745748|NCT00402324|3208494|Superiority or Other||||||<|0.001||||||All tests of treatment effects will be conducted at a two-sided alpha level of 0.05 unless otherwise stated.|Mixed Models Analysis|Mixed Model Repeated Measures (MMRM) Change = Therapy PooledINV Visit Baseline Baseline*Visit Therapy*Visit. P-value from therapy term in model.||The overall power of the two co-primary analyses—the probability of simultaneously rejecting both co-primary null hypotheses—for this sample size under assumed effect sizes of 0.5 and 0.45 is estimated as approximately 85-87% and 77-80%, respectively.|
1745749|NCT00402246|3208500|Superiority or Other|||||||0.154||||||The a priori threshold for statistical significance for was 0.05.|Mixed Models Analysis|Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.||A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.|
1745750|NCT00402246|3208501|Superiority or Other|||||||0.217||||||The a prior threshold for statistical significance was 0.05.|Mixed Models Analysis|Model was fit with randomization arm, device group (CRT-D vs. DR-ICD), and follow-up visit as fixed effects, and subject as a random effect.||A mixed model was fit to test whether patients followed through the remote management system will experience less anxiety than patients followed through in-office care.|
1745751|NCT00402246|3208503|Superiority or Other||compliance rate|0.814|||||1-Sided|95.0|0.79|||||||12-month compliance rate|
1745752|NCT00402246|3208503|Superiority or Other||compliance rate|0.815|||||1-Sided|95.0|0.792|||||||9-month compliance rate|
1745753|NCT00402246|3208503|Superiority or Other||compliance rate|0.815|||||1-Sided|95.0|0.793|||||||6-month compliance rate|
1745754|NCT00402246|3208503|Superiority or Other||compliance rate|0.761|||||1-Sided|95.0|0.737|||||||3-month compliance rate|
1745755|NCT00402246|3208504|Superiority or Other||Risk Ratio (RR)|0.82||||0.002|2-Sided|95.0|0.7|0.9||The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis was rejected.|negative binomial model|||The null hypothesis was that the mean LOS per hospitalization visit for patients in the remote arm was equal to that for similar patients in the in-office arm.|
1745756|NCT00402246|3208505|Superiority or Other||Mean Difference (Final Values)|-10.0|Standard Deviation|19.1|<|0.001|2-Sided|95.0|-13.1|-6.9||The a priori threshold for significance was an alpha level of 0.05.|t-test, 2 sided|||The null hypothesis is the time from event onset to clinical decision for both device events and symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.|
1745757|NCT00402246|3208506|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Deviation|4.3||0.779|2-Sided|95.0|-0.8|1.0||The a priori threshold for significance was an alpha level of 0.05.|t-test, 2 sided|||The null hypothesis is that the time from event onset to clinical decision for symptom-driven device interrogations for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.|
1745758|NCT00402246|3208508|Superiority or Other||probability|0.23||||||95.0|||||||||
1745759|NCT00402246|3208511|Superiority or Other||Hazard Ratio (HR)|1.45||||0.29|1-Sided|95.0||2.56||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|||An Andersen‐Gill proportional hazards regression model was fit to test the hypothesis that the hazard rate of transesophageal echocardiography (TEE) taken for patients in the remote arm is equal to that of similar patients in the in-office arm.|
1745760|NCT00402246|3208512|Superiority or Other||Hazard Ratio (HR)|1.14||||0.099|1-Sided|95.0||1.31||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple unscheduled clinic visits per subject.||An Andersen‐Gill proportional hazards regression model was fit to test the hypothesis that the hazard rates of the CV unscheduled clinic or urgent care visits for patients in the remote arm is equal to that of similar patients in the in-office arm.|
1745761|NCT00402246|3208512|Superiority or Other||Hazard Ratio (HR)|1.14||||0.325|1-Sided|95.0||1.43||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple ED visits per subject.||An Andersen‐Gill proportional hazards regression model was fit to test the hypothesis that the ED hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.|
1745762|NCT00402246|3208512|Superiority or Other||Hazard Ratio (HR)|1.06||||0.524|1-Sided|95.0||1.21||Model was fit with device group (CRT-D vs. DR-ICD) as a stratifying variable.|Andersen-Gill model|An Andersen-Gill model was utilized to account for multiple hospitalization events per subject.||An Andersen‐Gill proportional hazards regression model was fit to test the hypothesis that the CV hospitalization hazard rates for patients in the remote arm is equal to that of similar patients in the in-office arm.|
1745763|NCT00402246|3208513|Superiority or Other||Median Difference (Final Values)|17.4|||<|0.001||95.0||||The a priori threshold for significance was an alpha level of 0.05.|Wilcoxon (Mann-Whitney)|||The null hypothesis is that the time from a clinical event to a clinical decision for patients followed through the remote management system is greater than and equal to that of patients receiving only in-office care.|
1745764|NCT00402233|3208514|Superiority or Other||Mean Difference (Final Values)|-0.47||||0.48||95.0|-1.78|0.84|||ANCOVA||||
1745765|NCT00402233|3208514|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.37||95.0|-1.84|0.69|||ANCOVA||||
1745766|NCT00402233|3208514|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.39||95.0|-1.82|0.71|||ANCOVA||||
1745767|NCT00402233|3208515|Superiority or Other||Mean Difference (Final Values)|1.49||||0.0019||95.0|0.56|2.43|||ANCOVA||||
1745768|NCT00402233|3208515|Superiority or Other||Mean Difference (Final Values)|1.0||||0.03||95.0|0.094|1.9|||ANCOVA||||
1745769|NCT00402233|3208515|Superiority or Other||Mean Difference (Final Values)|1.14||||0.014||95.0|0.23|2.04|||ANCOVA||||
1745770|NCT00402233|3208516|Superiority or Other||Odds Ratio (OR)|0.687||||||95.0|0.317|1.492|||||||
1745771|NCT00402233|3208516|Superiority or Other||Odds Ratio (OR)|0.885||||||95.0|0.424|1.845|||||||
1745772|NCT00402233|3208516|Superiority or Other||Odds Ratio (OR)|0.893||||||95.0|0.431|1.849|||||||
1745773|NCT00402233|3208517|Superiority or Other||Mean Difference (Final Values)|-4.72|||<|0.0001||95.0|-6.91|-2.52|||ANCOVA||||
1745774|NCT00402233|3208517|Superiority or Other||Mean Difference (Final Values)|-4.41|||<|0.0001||95.0|-6.54|-2.28|||ANCOVA||||
1745775|NCT00402233|3208517|Superiority or Other||Mean Difference (Final Values)|-4.4|||<|0.0001||95.0|-6.53|-2.26|||ANCOVA||||
1745776|NCT00402168|3208533|Superiority or Other||Estimated Difference|0.0148|||||2-Sided|95.0|-0.002|0.0321||||||Difference in Symptom Distress between treatment groups.|
1745777|NCT00402168|3208533|Superiority or Other||Estimated Difference|0.0076|||||2-Sided|95.0|-0.01|0.0252||||||Difference in Symptom Occurrence between treatment groups.|
1745778|NCT00402168|3208535|Superiority or Other||Mean Difference (Net)|-0.3||||0.7892|2-Sided|95.0|-2.5|1.9|||ANCOVA|||Physical Component Scales (PCS)|
1745779|NCT00402168|3208535|Superiority or Other||Mean Difference (Net)|1.1||||0.4491|2-Sided|95.0|-1.7|3.9|||ANCOVA|||Mental Component Scales (MCS)|
1745780|NCT00402168|3208540|Superiority or Other||Difference|6.0|||||2-Sided|95.0|-0.1|13.8|||||||
1745781|NCT00402168|3208543|Superiority or Other||Percent Difference|1.1|||||2-Sided|95.0|-3.3|6.1||||||Participants surviving with a functioning graft by Month 12: For 95% CI of difference, exact method was used.|
1745782|NCT00402168|3208543|Superiority or Other||Percent Difference|1.1|||||2-Sided|95.0|-3.3|6.1||||||Participants surviving with a functioning graft by Month 6: For 95% Confidence Interval (CI) of difference, exact method was used.|
1745783|NCT00402168|3208544|Superiority or Other||Difference in Percentage|7.1|||||2-Sided|95.0|2.1|14.9||||||At Month 12, difference in percentage of participants with acute rejection using exact method.|
1745784|NCT00402168|3208544|Superiority or Other||Difference in Percentage|7.1|||||2-Sided|95.0|2.1|14.9||||||At Month 6, difference in percentage of participants with acute rejection (number with acute rejection/number randomized) using exact method.|
1745785|NCT00402051|3208552|Superiority or Other||Best Overall Response Rate (%)|20.0||||||95.0|11.1|31.8||||||Response rates were evaluated separately for each treatment arm|
1745786|NCT00402051|3208552|Superiority or Other||Best Overall Response Rate (%)|32.3||||||95.0|21.2|45.1||||||Response rates were evaluated separately for each treatment arm|
1745787|NCT00402051|3208554|Superiority or Other||6-Month PFS Rate|39.3|||||2-Sided|95.0|27.8|50.8||||||Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).|
1745788|NCT00402051|3208554|Superiority or Other||6-Month PFS Rate|52.8|||||2-Sided|95.0|40.3|65.3||||||Hypothesis testing was done independently for each treatment arm (no direct treatment group comparison).|
1745789|NCT00401973|3208562|Superiority or Other|||||||0.652||||||P-value for Change from Baseline|ANCOVA||||
1745790|NCT00401973|3208562|Superiority or Other|||||||0.404||||||P-value for Change from Baseline.|ANCOVA||||
1745791|NCT00401973|3208562|Superiority or Other|||||||0.474||||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA||||
1745792|NCT00401973|3208563|Superiority or Other|||||||0.038||||||P-value for Change from Baseline.|ANCOVA||||
1745793|NCT00401973|3208563|Superiority or Other|||||||0.037||||||P-value for Change from Baseline|ANCOVA||||
1745794|NCT00401973|3208563|Superiority or Other|||||||0.02||||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA||||
1745795|NCT00401973|3208564|Superiority or Other|||||||0.124||||||P-value for Change from Baseline.|ANCOVA||||
1745796|NCT00401973|3208564|Superiority or Other|||||||0.225||||||P-value for Change from Baseline.|ANCOVA||||
1745797|NCT00401973|3208564|Superiority or Other|||||||0.122||||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA||||
1745798|NCT00401973|3208565|Superiority or Other|||||||0.049||||||P-value for Change from Baseline.|ANCOVA||||
1745799|NCT00401973|3208565|Superiority or Other|||||||0.976||||||P-value for Change from Baseline.|ANCOVA||||
1745800|NCT00401973|3208565|Superiority or Other|||||||0.278||||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA||||
1745801|NCT00401973|3208566|Superiority or Other|||||||0.339||||||P-value for Change from Baseline.|ANCOVA||||
1745802|NCT00401973|3208566|Superiority or Other|||||||0.833||||||P-value for Change from Baseline.|ANCOVA||||
1745803|NCT00401973|3208566|Superiority or Other|||||||0.499||||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA||||
1745804|NCT00401973|3208567|Superiority or Other|||||||0.123||||||P-value for Change from Baseline.|ANCOVA||||
1745805|NCT00401973|3208567|Superiority or Other|||||||0.35||||||P-value for Change from Baseline.|ANCOVA||||
1745806|NCT00401973|3208567|Superiority or Other|||||||0.152||||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA||||
1745807|NCT00401973|3208568|Superiority or Other|||||||0.071||||||P-value for Change from Baseline.|ANCOVA||||
1745808|NCT00401973|3208568|Superiority or Other|||||||0.015||||||P-value for Change from Baseline.|ANCOVA||||
1745809|NCT00401973|3208568|Superiority or Other|||||||0.017||||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA||||
1745810|NCT00401973|3208569|Superiority or Other|||||||0.029||||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA||||
1745811|NCT00401973|3208569|Superiority or Other|||||||0.016||||||P-value for Change from Baseline.|ANCOVA||||
1745812|NCT00401973|3208569|Superiority or Other|||||||0.173||||||P-value for Change from Baseline.|ANCOVA||||
1745813|NCT00401973|3208570|Superiority or Other|||||||0.125||||||P-value for Change from Baseline.|ANCOVA||||
1745814|NCT00401973|3208570|Superiority or Other|||||||0.637||||||P-value for Change from Baseline.|ANCOVA||||
1745815|NCT00401973|3208570|Superiority or Other|||||||0.498||||||P-value for Change from Baseline for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|ANCOVA||||
1745816|NCT00401973|3208571|Superiority or Other|||||||0.036|||||||Mixed Models Analysis|Repeated Measures Analysis|||
1745817|NCT00401973|3208571|Superiority or Other|||||||0.113|||||||Mixed Models Analysis|Repeated Measures Analysis||Hypothesis=weight gain associated with olanzapine can be prevented or mitigated with an adjunctive pharmacological algorithm.|
1745818|NCT00401973|3208571|Superiority or Other|||||||0.065||||||P-value for Olanzapine versus pooled olanzapine+amantadine and olanzapine+metformin.|Mixed Models Analysis|Repeated Measures Analysis||To detect a difference between treatment arms of 3.06 kg in mean weight change from baseline to endpoint, 150 patients must be enrolled in stepped intervention arm and 50 in control arm. Assuming a standard deviation of 6.87 kg, there is 80% power to detect a difference between treatment arms on a 1-sided 2-sample t-test at the 5% significance level. Primary analysis was the comparison of mean weight change for 'olanzapine only' versus pooled 'olanzapine & adjunctive treatment' arm at Week 22.|
1745819|NCT00401726|3208614|Superiority or Other|||||||0.961|||||||Cochran-Mantel-Haenszel|p-value based on comparison of mean score differences||CGI-I raw scores (range 1-7) analyzed by generalized Cochran-Mantel-Haenszel (CMH) test, stratified by study center using the ridit scoring option.|
1745820|NCT00401726|3208615|Superiority or Other||Mean Difference (Net)|-1.0||||0.123||95.0|-2.27|0.27|||ANCOVA||||
1745821|NCT00401726|3208616|Superiority or Other||Mean Difference (Net)|-0.25||||0.805||95.0|-2.24|1.74|||ANCOVA||||
1745822|NCT00401726|3208617|Superiority or Other||Risk Difference (RD)|0.57||||0.728|||||||Chi-squared||||
1745823|NCT00401726|3208618|Superiority or Other||Mean Difference (Net)|-0.11||||0.829||95.0|-1.09|0.87|||ANCOVA||||
1745824|NCT00401726|3208619|Superiority or Other||Mean Difference (Net)|-0.17||||0.148||95.0|-0.41|0.06|||ANCOVA||||
1745825|NCT00401726|3208620|Superiority or Other||Mean Difference (Net)|0.16||||0.76||95.0|-0.92|1.25|||ANCOVA||||
1745826|NCT00401726|3208621|Superiority or Other||Risk Difference (RD)|5.25||||0.218|||||||Chi-squared||||
1745827|NCT00401622|3208622|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.11||0.45|2-Sided|95.0|-0.38|0.04|||ANCOVA|Visit 1 A1c measurement used as the covariate||Change in A1C from baseline to week 52 between the OneTouch® Ultra®2 and control BGMS|
1745828|NCT00401622|3208623|Superiority or Other||Mean Difference (Final Values)|7.56|Standard Error of the Mean|7.51||0.31|2-Sided|95.0|-7.24|22.36|||t-test, 2 sided||||
1745829|NCT00401544|3208628|Superiority or Other||Percentage of participants|74.0||||||95.0|66.0|82.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745830|NCT00401544|3208628|Superiority or Other||Percentage of participants|53.0||||||95.0|44.0|62.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745894|NCT00400153|3208778|Superiority or Other||Mean Difference (Final Values)|0.398|Standard Error of the Mean|0.065|<|0.0001||95.0|||||ANOVA|||Difference: Respimat − MDI|
1745831|NCT00401544|3208629|Superiority or Other||Percentage of participants|59.0||||||95.0|50.0|68.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745832|NCT00401544|3208629|Superiority or Other||Percentage of participants|68.0||||||95.0|59.0|76.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745833|NCT00401544|3208630|Superiority or Other||Percentage of participants|25.0||||||95.0|14.0|36.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745834|NCT00401544|3208630|Superiority or Other||Percentage of participants|28.0||||||95.0|17.0|40.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745835|NCT00401544|3208630|Superiority or Other||Percentage of participants|31.0||||||95.0|19.0|42.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745836|NCT00401544|3208630|Superiority or Other||Percentage of participants|26.0||||||95.0|15.0|38.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745837|NCT00401544|3208631|Superiority or Other||Percentage of participants|39.0||||||95.0|30.0|47.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745838|NCT00401544|3208631|Superiority or Other||Percentage of participants|35.0||||||95.0|27.0|44.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745839|NCT00401544|3208632|Superiority or Other||Percentage of participants|38.0||||||95.0|29.0|47.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745840|NCT00401544|3208632|Superiority or Other||Percentage of participants|36.0||||||95.0|27.0|44.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745841|NCT00401544|3208637|Superiority or Other||Percentage of participants|62.0||||||95.0|54.0|71.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745842|NCT00401544|3208637|Superiority or Other||Percentage of participants|73.0||||||95.0|64.0|81.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745843|NCT00401544|3208638|Superiority or Other||Percentage of participants|63.0||||||95.0|54.0|72.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745844|NCT00401544|3208638|Superiority or Other||Percentage of participants|71.0||||||95.0|63.0|80.0|||||Binomial proportion with confidence limit calculation using the normal approximation, and converted to percentages.||
1745845|NCT00401375|3208657|Other||Mean Difference (Final Values)|0.13||||0.3575||||||Threshold for significance at 0.05 level.|Log Rank|||Treatment comparisons were made at the overall α=0.05 level (2-sided) using a closed sequential procedure. Placebo and MNTX 24 mg groups were compared first.|
1745846|NCT00401375|3208657|Other||Mean Difference (Final Values)|-0.23||||0.4259||||||Threshold for significance at 0.05 level.|Log Rank|||Treatment comparisons were made at the overall α=0.05 level (2-sided) using a closed sequential procedure. Placebo and MNTX 24 mg groups were compared first.|
1745847|NCT00401258|3208658|Superiority or Other|||||||0.006||||||Refers to family sub scale|Mixed Models Analysis||||
1745848|NCT00401258|3208658|Superiority or Other|||||||0.087||||||Refers to social sub scale|Mixed Models Analysis||||
1745849|NCT00401258|3208658|Superiority or Other|||||||0.004||||||Refers to work/school sub-scale|Mixed Models Analysis||||
1745850|NCT00401258|3208659|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1745851|NCT00401258|3208660|Superiority or Other|||||||0.031|||||||Mixed Models Analysis||||
1745852|NCT00401258|3208662|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1745853|NCT00401258|3208663|Superiority or Other|||||||0.001|||||||Mixed Models Analysis||||
1745854|NCT00401258|3208664|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Average pain interference statistical analysis|
1745855|NCT00401258|3208664|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||Average pain severity statistical analysis|
1745856|NCT00401258|3208665|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1745857|NCT00401245|3208668|Superiority or Other||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 16) value with 0.|
1745858|NCT00401245|3208668|Superiority or Other||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the base value and post-baseline (Week 12) value with 0.|
1745859|NCT00401245|3208668|Superiority or Other||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 8) value with 0.|
1745860|NCT00401245|3208668|Superiority or Other||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|t-test, 2 sided|||Comparison was made between the difference in the means from the baseline value and post-baseline (Week 4) value with 0.|
1745861|NCT00401245|3208675|Superiority or Other|||||||0.017||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Chi-squared|||Overall comparison was made between each titration regimen and the control regimen (100 mg).|
1745862|NCT00401245|3208677|Superiority or Other|||||||0.929||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.|
1745895|NCT00400153|3208783|Superiority or Other||Mean Difference (Final Values)|0.018|Standard Error of the Mean|0.066||0.788|2-Sided|95.0|-0.111|0.146|||ANCOVA|||This analysis is purely exploratory.|
1749495|NCT00360568|3214234|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1745863|NCT00401245|3208677|Superiority or Other|||||||0.005||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.|
1745864|NCT00401245|3208677|Superiority or Other|||||||0.078||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.|
1745865|NCT00401245|3208678|Superiority or Other|||||||0.009||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor|
1745866|NCT00401245|3208678|Superiority or Other|||||||0.997||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor|
1745867|NCT00401245|3208678|Superiority or Other|||||||0.092||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor|
1745868|NCT00401245|3208679|Superiority or Other||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg/Placebo, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.|
1745869|NCT00401245|3208679|Superiority or Other||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50/25 mg, ANOVA was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.|
1745870|NCT00401245|3208679|Superiority or Other||||||<|0.001||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANOVA|||For DVS 50 mg QOD, analysis of variance (ANOVA) was used to compare the DESS score between each tapering regimen and the control regimen (no tapering) for the titration population, where treatment was kept as the factor.|
1745871|NCT00401245|3208680|Superiority or Other|||||||0.024||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Chi-squared|||Overall comparison was made between each titration regimen and the control regimen (100 mg).|
1745872|NCT00400946|3208702|Superiority|||||||0.6|||||||Fisher Exact||||
1745873|NCT00400712|3208725|Superiority or Other|||||||0.78||||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA||||
1745874|NCT00400712|3208726|Superiority or Other|||||||0.66||||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA||||
1745875|NCT00400712|3208727|Superiority or Other|||||||0.6|||||||ANCOVA|controlled for baseline values|||
1745876|NCT00400712|3208728|Superiority or Other|||||||0.72|||||||ANCOVA|adjusted for baseline values|||
1745877|NCT00400712|3208729|Superiority or Other|||||||0.45|||||||ANCOVA|||ANCOVA - comparing absolute measures and including baseline as co-variate|
1745878|NCT00400712|3208730|Superiority or Other|||||||0.83||||||Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|ANCOVA||||
1745879|NCT00400712|3208731|Superiority or Other|||||||0.44|||||||ANCOVA|Examined whether there were differences between groups at 1 year with baseline measures serving as the covariate with a two-sided alpha of 0.05|||
1745880|NCT00400179|3208756|Superiority or Other||Hazard Ratio (HR)|0.92||||0.1983|2-Sided|95.0|0.8|1.05|||Log Rank||||
1745881|NCT00400179|3208757|Superiority or Other||Hazard Ratio (HR)|0.87||||0.032|2-Sided|95.0|0.77|0.99|||Log Rank||||
1745882|NCT00400179|3208758|Superiority or Other||Hazard Ratio (HR)|0.99||||0.9158|2-Sided|95.0|0.86|1.14|||Log Rank||||
1745883|NCT00400179|3208759|Superiority or Other||Hazard Ratio (HR)|0.77||||0.0808|2-Sided|95.0|0.57|1.03|||Log Rank||||
1745884|NCT00400179|3208760|Superiority or Other|||||||0.3952|||||||Fisher Exact||||
1745885|NCT00400153|3208769|Superiority or Other||Mean Difference (Final Values)|0.464|Standard Error of the Mean|0.063|<|0.0001||95.0|||||ANOVA|||Difference: Respimat − MDI|
1745886|NCT00400153|3208770|Superiority or Other||Mean Difference (Final Values)|0.402|Standard Error of the Mean|0.062|<|0.0001||95.0|||||ANOVA|||Difference: Respimat − MDI|
1745887|NCT00400153|3208771|Superiority or Other||Mean Difference (Final Values)|0.378|Standard Error of the Mean|0.06|<|0.0001||95.0|||||ANOVA|||Difference: Respimat − MDI|
1745888|NCT00400153|3208772|Superiority or Other||Mean Difference (Final Values)|0.265|Standard Error of the Mean|0.05|<|0.0001||95.0|||||ANOVA|||Difference: Respimat − MDI|
1745889|NCT00400153|3208773|Superiority or Other||Mean Difference (Final Values)|0.226|Standard Error of the Mean|0.047|<|0.0001||95.0|||||ANOVA|||Difference: Respimat − MDI|
1745890|NCT00400153|3208774|Superiority or Other||Mean Difference (Final Values)|0.421|Standard Error of the Mean|0.061|<|0.0001||95.0|||||ANOVA|||Difference: Respimat − MDI|
1745891|NCT00400153|3208775|Superiority or Other||Mean Difference (Final Values)|0.508|Standard Error of the Mean|0.058|<|0.0001||95.0|||||ANOVA|||Difference: Respimat − MDI|
1745892|NCT00400153|3208776|Superiority or Other||Mean Difference (Final Values)|1.612|Standard Error of the Mean|0.075|<|0.0001||95.0|||||ANOVA|||Difference: Respimat − MDI|
1745893|NCT00400153|3208777|Superiority or Other||Mean Difference (Final Values)|0.482|Standard Error of the Mean|0.065|<|0.0001||95.0|||||ANOVA|||Difference: Respimat − MDI|
1745966|NCT00399542|3208886|Superiority or Other (legacy)|||||||0.352|||||||van Elteren nonparametric test||||
1745896|NCT00400153|3208783|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.065||0.139||95.0|-0.031|0.225|||ANCOVA||||
1745897|NCT00400153|3208784|Superiority or Other||Mean Difference (Final Values)|-0.069|Standard Error of the Mean|0.062||0.266|2-Sided|95.0|-0.19|0.053|||ANCOVA|||This analysis is purely exploratory.|
1745898|NCT00400153|3208784|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.006|Standard Error of the Mean|0.062||0.924||95.0|-0.115|0.127|||ANCOVA||||
1745899|NCT00400153|3208785|Superiority or Other||Mean Difference (Final Values)|-0.054|Standard Error of the Mean|0.056||0.336|2-Sided|95.0|-0.165|0.056|||ANCOVA|||This analysis is purely exploratory.|
1745900|NCT00400153|3208785|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.077|Standard Error of the Mean|0.056||0.173||95.0|-0.034|0.187|||ANCOVA||||
1745901|NCT00400153|3208786|Superiority or Other||Mean Difference (Final Values)|2.4376|Standard Error of the Mean|2.0874||0.2431|2-Sided|95.0|-1.6578|6.533|||ANCOVA|||This analysis is purely exploratory.|
1745902|NCT00400153|3208786|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|1.6526|Standard Error of the Mean|2.0653||0.4238||95.0|-2.3995|5.7047|||ANCOVA||||
1745903|NCT00400153|3208787|Superiority or Other||Mean Difference (Final Values)|0.01573|Standard Error of the Mean|0.03033||0.604|2-Sided|95.0|-0.04376|0.07523|||ANCOVA|||This analysis is purely exploratory.|
1745904|NCT00400153|3208787|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.0129|Standard Error of the Mean|0.03002||0.6674||95.0|-0.04598|0.07179|||ANCOVA||||
1745905|NCT00400153|3208788|Superiority or Other||Mean Difference (Final Values)|0.06501|Standard Error of the Mean|0.03225||0.044|2-Sided|95.0|0.001746|0.1283|||ANCOVA|||This analysis is purely exploratory.|
1745906|NCT00400153|3208788|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.007734|Standard Error of the Mean|0.03199||0.809||95.0|-0.05503|0.0705|||ANCOVA||||
1745907|NCT00400153|3208789|Superiority or Other||Mean Difference (Final Values)|-0.1554|Standard Error of the Mean|0.122||0.203|2-Sided|95.0|-0.3947|0.08395|||ANCOVA|||This analysis is purely exploratory.|
1745908|NCT00400153|3208789|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.1091|Standard Error of the Mean|0.1206||0.3659||95.0|-0.1276|0.3458|||ANCOVA||||
1745909|NCT00400153|3208790|Superiority or Other||Mean Difference (Final Values)|-0.01995|Standard Error of the Mean|0.06441||0.7569|2-Sided|95.0|-0.1463|0.1064|||ANCOVA|||This analysis is purely exploratory.|
1745910|NCT00400153|3208790|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.00045|Standard Error of the Mean|0.06396||0.9943||95.0|-0.1259|0.125|||ANCOVA||||
1745911|NCT00400153|3208795|Superiority or Other||Mean Difference (Final Values)|0.126|Standard Error of the Mean|0.023|<|0.0001||95.0|0.081|0.171|||ANCOVA|||This analysis is purely exploratory.|
1745912|NCT00400153|3208796|Superiority or Other||Mean Difference (Final Values)|0.118|Standard Error of the Mean|0.023|<|0.0001||95.0|0.072|0.163|||ANCOVA|||This analysis is purely exploratory.|
1745913|NCT00400153|3208797|Superiority or Other||Mean Difference (Final Values)|0.129|Standard Error of the Mean|0.023|<|0.0001||95.0|0.084|0.174|||ANCOVA|||This analysis is purely exploratory.|
1745914|NCT00400153|3208798|Superiority or Other||Mean Difference (Final Values)|0.121|Standard Error of the Mean|0.024|<|0.0001||95.0|0.075|0.167|||ANCOVA|||This analysis is purely exploratory.|
1745915|NCT00400153|3208799|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.013|Standard Error of the Mean|0.023||0.563||95.0|-0.032|0.058|||ANCOVA||||
1745916|NCT00400153|3208800|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.015|Standard Error of the Mean|0.023||0.5294||95.0|-0.06|0.031|||ANCOVA||||
1745917|NCT00400153|3208801|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.004|Standard Error of the Mean|0.023||0.873||95.0|-0.041|0.049|||ANCOVA||||
1745918|NCT00400153|3208802|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.011|Standard Error of the Mean|0.023||0.6244||95.0|-0.057|0.034|||ANCOVA||||
1745919|NCT00400153|3208803|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.007|Standard Error of the Mean|0.023||0.7652||95.0|-0.053|0.039|||ANCOVA||||
1745920|NCT00400153|3208804|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.001|Standard Error of the Mean|0.022||0.959||95.0|-0.045|0.042|||ANCOVA||||
1745921|NCT00400153|3208805|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.023||0.3895||95.0|-0.064|0.025|||ANCOVA||||
1745922|NCT00400153|3208806|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.043|Standard Error of the Mean|0.024||0.0688||95.0|-0.003|0.09|||ANCOVA||||
1745923|NCT00400153|3208807|Superiority or Other||Mean Difference (Final Values)|0.094|Standard Error of the Mean|0.021|<|0.0001||95.0|0.054|0.135|||ANCOVA|||This analysis is purely exploratory.|
1745924|NCT00400153|3208808|Superiority or Other||Mean Difference (Final Values)|0.097|Standard Error of the Mean|0.021|<|0.0001||95.0|0.056|0.138|||ANCOVA|||This analysis is purely exploratory.|
1745925|NCT00400153|3208809|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.021|<|0.0001||95.0|0.049|0.132|||ANCOVA|||This analysis is purely exploratory.|
1745926|NCT00400153|3208810|Superiority or Other||Mean Difference (Final Values)|0.112|Standard Error of the Mean|0.022|<|0.0001||95.0|0.069|0.154|||ANCOVA|||This analysis is purely exploratory.|
1745927|NCT00400153|3208811|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.004|Standard Error of the Mean|0.02||0.8288||95.0|-0.044|0.035|||ANCOVA||||
1745928|NCT00400153|3208812|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.02||0.3499||95.0|-0.058|0.021|||ANCOVA||||
1745929|NCT00400153|3208813|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.02||0.3505||95.0|-0.059|0.021|||ANCOVA||||
1745930|NCT00400153|3208814|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.017|Standard Error of the Mean|0.021||0.417||95.0|-0.058|0.024|||ANCOVA||||
1745931|NCT00400153|3208827|Superiority or Other||Mean Difference (Final Values)|0.068|Standard Error of the Mean|0.011|<|0.0001||95.0|0.047|0.089|||ANCOVA|||This analysis is purely exploratory.|
1745932|NCT00400153|3208828|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.011|<|0.0001||95.0|0.04|0.081|||ANCOVA|||This analysis is purely exploratory.|
1745933|NCT00400153|3208829|Superiority or Other||Mean Difference (Final Values)|0.065|Standard Error of the Mean|0.011|<|0.0001||95.0|0.044|0.087|||ANCOVA|||This analysis is purely exploratory.|
1745934|NCT00400153|3208830|Superiority or Other||Mean Difference (Final Values)|0.065|Standard Error of the Mean|0.011|<|0.0001||95.0|0.043|0.087|||ANCOVA|||This analysis is purely exploratory.|
1745935|NCT00400153|3208831|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.003|Standard Error of the Mean|0.011||0.8065||95.0|-0.018|0.024|||ANCOVA||||
1745936|NCT00400153|3208832|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.013|Standard Error of the Mean|0.011||0.2274||95.0|-0.033|0.008|||ANCOVA||||
1745937|NCT00400153|3208833|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.006|Standard Error of the Mean|0.011||0.5711||95.0|-0.015|0.028|||ANCOVA||||
1745938|NCT00400153|3208834|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.011||0.0743||95.0|-0.042|0.002|||ANCOVA||||
1745939|NCT00400153|3208835|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.011|Standard Error of the Mean|0.011||0.3355||95.0|-0.033|0.011|||ANCOVA||||
1745940|NCT00400153|3208836|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.011||0.3749||95.0|-0.032|0.012|||ANCOVA||||
1745941|NCT00400153|3208837|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established.|Mean Difference (Final Values)|0.026|Standard Error of the Mean|0.012||0.0258||95.0|0.003|0.049|||ANCOVA||||
1745942|NCT00400153|3208838|Superiority or Other||Mean Difference (Final Values)|0.047|Standard Error of the Mean|0.01|<|0.0001||95.0|0.027|0.067|||ANCOVA|||This analysis is purely exploratory.|
1745943|NCT00400153|3208839|Superiority or Other||Mean Difference (Final Values)|0.044|Standard Error of the Mean|0.01|<|0.0001||95.0|0.024|0.065|||ANCOVA|||This analysis is purely exploratory.|
1745944|NCT00400153|3208840|Superiority or Other||Mean Difference (Final Values)|0.061|Standard Error of the Mean|0.011|<|0.0001||95.0|0.04|0.083|||ANCOVA|||This analysis is purely exploratory.|
1745945|NCT00400153|3208841|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.014||||0.1433||95.0|-0.033|0.005|||ANCOVA||||
1745946|NCT00400153|3208842|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.007|Standard Error of the Mean|0.01||0.4888||95.0|-0.026|0.013|||ANCOVA||||
1745947|NCT00400153|3208843|Non-Inferiority or Equivalence|This analysis is purely exploratory. Non-inferiority margin is not established for this comparison.|Mean Difference (Final Values)|-0.016|Standard Error of the Mean|0.01||0.124||95.0|-0.036|0.004|||ANCOVA||||
1745948|NCT00400153|3208844|Non-Inferiority or Equivalence|Non-inferiority margin is 0.05 liters|Mean Difference (Final Values)|-0.017|Standard Error of the Mean|0.011||0.1389||95.0|-0.039|0.005|||ANCOVA||||
1745949|NCT00400153|3208845|Superiority or Other||Mean Difference (Final Values)|0.047|Standard Error of the Mean|0.01|<|0.0001||95.0|0.028|0.066|||ANCOVA||||
1745950|NCT00400153|3208846|Non-Inferiority or Equivalence|Non-inferiority margin is 0.05 liter|Mean Difference (Final Values)|-0.0035|Standard Error of the Mean|0.0095||0.7135||95.0|-0.0222|0.0152|||ANCOVA||||
1745951|NCT00399542|3208871|Superiority or Other (legacy)|||||||0.495|||||||van Elteren nonparametric test||||
1745952|NCT00399542|3208872|Superiority or Other (legacy)|||||||0.29|||||||van Elteren nonparametric test||||
1745953|NCT00399542|3208873|Superiority or Other (legacy)|||||||0.06|||||||van Elteren nonparametric test||||
1745954|NCT00399542|3208874|Superiority or Other (legacy)|||||||0.062|||||||ANCOVA|Adjusted for center|||
1745955|NCT00399542|3208875|Superiority or Other (legacy)|||||||0.073|||||||Cochran-Mantel-Haenszel||||
1745956|NCT00399542|3208876|Superiority or Other (legacy)|||||||0.023|||||||Cochran-Mantel-Haenszel||||
1745957|NCT00399542|3208877|Superiority or Other (legacy)|||||||0.339|||||||van Elteren nonparametric test|Adjusted for center|||
1745958|NCT00399542|3208878|Superiority or Other (legacy)|||||||0.373|||||||van Elteren nonparametric test|Adjusted for center|||
1745959|NCT00399542|3208879|Superiority or Other (legacy)|||||||0.146|||||||van Elteren nonparametric test|Adjusted for center|||
1745960|NCT00399542|3208880|Superiority or Other (legacy)|||||||0.11|||||||van Elteren nonparametric test|Adjusted for center|||
1745961|NCT00399542|3208881|Superiority or Other (legacy)|||||||0.082|||||||van Elteren nonparametric test|Adjusted for center|||
1745962|NCT00399542|3208882|Superiority or Other (legacy)|||||||0.177|||||||van Elteren nonparametric test|Adjusted for center|||
1745963|NCT00399542|3208883|Superiority or Other (legacy)|||||||0.722|||||||van Elteren nonparametric test|Adjusted for center|||
1745964|NCT00399542|3208884|Superiority or Other (legacy)|||||||0.275|||||||van Elteren nonparametric test|Adjusted for center|||
1745965|NCT00399542|3208885|Superiority or Other (legacy)|||||||0.18|||||||van Elteren nonparametric test|Adjusted for center|||
1745967|NCT00399542|3208887|Superiority or Other (legacy)|||||||0.945|||||||van Elteren nonparametric test|Adjusted for center|||
1745968|NCT00399542|3208888|Superiority or Other (legacy)|||||||0.271|||||||van Elteren nonparametric test|Adjusted for center|||
1745969|NCT00399542|3208889|Superiority or Other (legacy)|||||||0.224|||||||van Elteren nonparametric test|Adjusted for center|||
1745970|NCT00399542|3208890|Superiority or Other (legacy)|||||||0.663|||||||van Elteren nonparametric test|Adjusted for center|||
1745971|NCT00399542|3208891|Superiority or Other (legacy)|||||||0.008||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality|||
1745972|NCT00399542|3208892|Superiority or Other (legacy)|||||||0.047||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality|||
1745973|NCT00399542|3208893|Superiority or Other (legacy)|||||||0.303||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality|||
1745974|NCT00399542|3208894|Superiority or Other (legacy)|||||||0.3|||||||Cochran-Mantel-Haenszel||||
1745975|NCT00399542|3208895|Superiority or Other (legacy)|||||||0.185|||||||van Elteren nonparametric test|Adjusted for center|||
1745976|NCT00399542|3208896|Superiority or Other (legacy)|||||||0.163|||||||van Elteren nonparametric test|Adjusted for center|||
1745977|NCT00399542|3208897|Superiority or Other (legacy)|||||||0.151|||||||van Elteren nonparametric test|Adjusted for center|||
1745978|NCT00399542|3208898|Superiority or Other (legacy)|||||||0.391|||||||van Elteren nonparametric test|Adjusted for center|||
1745979|NCT00399542|3208899|Superiority or Other (legacy)|||||||0.023||||||No adjustment|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||70.6% improvement in response with lubiprostone at 90% statistical power|
1745980|NCT00399360|3208904|Superiority or Other|||||||0.02|||||||ANOVA||||
1745981|NCT00399360|3208905|Superiority or Other|||||||0.05|||||||ANOVA||||
1745982|NCT00399360|3208906|Superiority or Other|||||||0.63|||||||ANOVA||||
1745983|NCT00399360|3208907|Superiority or Other|||||||0.1|||||||ANOVA||||
1745984|NCT00399360|3208908|Superiority or Other|||||||0.03|||||||ANOVA||||
1745985|NCT00399360|3208909|Superiority or Other|||||||0.85|||||||ANOVA||||
1745986|NCT00399360|3208910|Superiority or Other|||||||0.13|||||||ANOVA||||
1745987|NCT00399360|3208911|Superiority or Other|||||||0.08|||||||ANOVA||||
1745988|NCT00399360|3208912|Superiority or Other|||||||0.8|||||||ANOVA||||
1745989|NCT00399360|3208913|Superiority or Other|||||||0.37|||||||ANOVA||||
1745990|NCT00398918|3208926|Superiority or Other||Mean Difference (Final Values)|2.2|Standard Error of the Mean|5.7||0.61||95.0||||P value shown is for a post-hoc comparison of least squares means generated by the mixed model used.|Mixed Models Analysis||Analysis for difference between DSMT scores at 40 minutes post alcohol ingestion for zonisamide and placebo involved post-hoc comparisons of least squares means.|Null hypothesis: No difference in DSMT scores for zonisamide and placebo treatments 40 minutes after ingestion of ethanol.|
1745991|NCT00398918|3208927|Superiority or Other||Mean Difference (Final Values)|-9.2|Standard Error of the Mean|3.4|<|0.05||95.0|||||Mixed Models Analysis|Results presented are for post-hoc comparisons of least squares means with Tukey-Kramer adjucted p values.|The estimated value is for the difference between the means obtained for the second hour of the self-administration sessions for the placebo and zonisamide conditions.|The analysis involved a within subjects comparison. The null hypothesis was that there would be no difference in the amount of ethanol consumed in either the first or second hour of self-administration sessions. Results presented here are for the second hour of the self-administration sessions.|
1745992|NCT00398476|3208939|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.02|||||||Cochran-Mantel-Haenszel||||
1745993|NCT00398476|3208940|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.694|||||||Cochran-Mantel-Haenszel||||
1745994|NCT00398476|3208941|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.108|||||||Cochran-Mantel-Haenszel||||
1745995|NCT00398476|3208942|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.205|||||||Cochran-Mantel-Haenszel||||
1745996|NCT00398476|3208943|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.221|||||||Cochran-Mantel-Haenszel||||
1745997|NCT00398476|3208944|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Mean Difference (Net)|0.0||||0.797|||||||Cochran-Mantel-Haenszel|||This analysis is for DAQ|
1745998|NCT00398476|3208944|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.968|||||||Cochran-Mantel-Haenszel|||This analysis is for IAQ|
1746140|NCT00395876|3209376|Superiority or Other||Mean Difference (Final Values)|11.4||||0.1385||95.0|-3.1|25.8||Stratified by baseline weight (< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel||||
1745999|NCT00398476|3208945|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in DAQ|
1746000|NCT00398476|3208945|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001|||||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in IAQ|
1746001|NCT00398476|3208946|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.296|||||||Cochran-Mantel-Haenszel|||This analysis is for DAQ|
1746002|NCT00398476|3208946|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.797|||||||Cochran-Mantel-Haenszel|||This analysis is for IAQ|
1746003|NCT00398476|3208947|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.434||95.0|||||Cochran-Mantel-Haenszel||||
1746004|NCT00398476|3208948|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel||||
1746005|NCT00398476|3208949|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.592||95.0|||||Cochran-Mantel-Haenszel||||
1746006|NCT00398476|3208950|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel||||
1746007|NCT00398476|3208951|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.871||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for DAQ Items|
1746008|NCT00398476|3208952|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP).|Median Difference (Net)|0.0||||0.845||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for IAQ Irtems|
1746009|NCT00398476|3208953|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.056||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for all DAQ items|
1746010|NCT00398476|3208954|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Net)|0.0||||0.255||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg in IAQ|
1746011|NCT00398476|3208955|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Final Values)|-1.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for DAQ items|
1746012|NCT00398476|3208955|Equivalence|Assuming that 65% of participants indicate an overall preference for FF over FP, then a sample size of 125 participants will provide 93% power to show that difference in proportions (i.e., 65% favoring FF vs 35% favoring FP)|Median Difference (Final Values)|-2.0|||<|0.001||95.0|||||Cochran-Mantel-Haenszel|||Comparison of FF 110 µg and FP 200 µg for IAQ items|
1746013|NCT00398476|3208956|Other|||||||0.587|||||||Cochran-Mantel-Haenszel|||Analysis for Urge to sneeze|
1746014|NCT00398476|3208956|Other|||||||0.07|||||||Cochran-Mantel-Haenszel|||Analysis for Less irritating|
1746015|NCT00398476|3208956|Other|||||||0.408|||||||Cochran-Mantel-Haenszel|||Analysis for More soothing|
1746016|NCT00398476|3208956|Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Less run out nose|
1746017|NCT00398476|3208956|Other||||||<|0.037|||||||Cochran-Mantel-Haenszel|||Analysis for Less drip down throat|
1746018|NCT00398476|3208956|Other||||||<|0.002|||||||Cochran-Mantel-Haenszel|||Analysis for After-taste|
1746019|NCT00398476|3208956|Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Immediate taste|
1746020|NCT00398476|3208956|Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Analysis for Scent/odor|
1746021|NCT00398476|3208956|Other||||||<|0.003|||||||Cochran-Mantel-Haenszel|||Analysis for overall product preference|
1746022|NCT00398216|3208972|Superiority or Other|||||||0.123|||||||Fisher Exact||||
1746023|NCT00398216|3208972|Superiority or Other|||||||0.124|||||||Fisher Exact||||
1746024|NCT00398216|3208972|Superiority or Other|||||||0.122|||||||Fisher Exact||||
1746025|NCT00398216|3208972|Superiority or Other|||||||0.25|||||||Fisher Exact||||
1746026|NCT00398216|3208975|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1746027|NCT00398216|3208975|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1746028|NCT00398216|3208975|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1746029|NCT00398216|3208975|Superiority or Other||||||<|0.003|||||||Fisher Exact||||
1746617|NCT00391274|3210133|Superiority or Other||Hazard Ratio (HR)|1.05||||0.7784||95.0|0.75|1.46|||Regression, Cox|Treatment was the only covariate.|||
1746030|NCT00397930|3209041|Superiority or Other||Mean Difference (Final Values)|-0.79|Standard Error of the Mean|0.3||0.009|2-Sided|||||Between-group differences are expressed as differences in mean Post-Pre change for the global sleep quality PSQI score.|ANCOVA|ANCOVA with post-intervention PSQI score as the outcome, with Group as the factor, and pre-intervention PSQI score as the covariate.|The negative estimated value indicates that the mean Post-Pre change for the YOCAS group was less than that of the Control group.|"H0: There is no statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level.~Ha: There is a statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level."|
1746031|NCT00397839|3209067|Superiority or Other||Mean Difference (Net)|0.5|||<|0.001||95.0|0.33|0.75|||Cochran-Mantel-Haenszel||Relative risk|Both Total Hip and Total Spine BMD|
1746032|NCT00397839|3209067|Superiority or Other||Mean Difference (Net)|0.41|||<|0.001||95.0|0.23|0.72|||Cochran-Mantel-Haenszel||Relative risk|Both Total Hip and Total Spine BMD at Month 6|
1746033|NCT00397839|3209067|Superiority or Other||Mean Difference (Net)|0.57|||<|0.001||95.0|0.41|0.8|||Cochran-Mantel-Haenszel||Relative risk|Total Hip BMD at Month 12|
1746034|NCT00397839|3209067|Superiority or Other||Mean Difference (Net)|0.46|||<|0.001||95.0|0.3|0.72|||Cochran-Mantel-Haenszel||Relative risk|Total Hip BMD at Month 6|
1746035|NCT00397839|3209067|Superiority or Other||Mean Difference (Net)|0.85|||<|0.044||95.0|0.72|1.01|||Cochran-Mantel-Haenszel||Relative risk|Total Spine BMD at Month 12|
1746036|NCT00397839|3209067|Superiority or Other||Mean Difference (Net)|0.91|||<|0.362||95.0|0.73|1.13|||Cochran-Mantel-Haenszel||Relative risk|Total Spine BMD at Month 6|
1746037|NCT00397839|3209068|Superiority or Other||Mean Difference (Net)|1.18||||0.031||95.0|0.11|2.25|||ANCOVA|||Trochanter subgroup|
1746038|NCT00397839|3209068|Superiority or Other||Mean Difference (Net)|1.18||||0.031||95.0|0.11|2.25|||ANCOVA|||Femoral Neck subgroup|
1746039|NCT00397839|3209068|Superiority or Other||Mean Difference (Net)|1.75|||<|0.001||95.0|1.11|2.4|||ANCOVA|||Total Hip subgroup|
1746040|NCT00397839|3209069|Superiority or Other||Mean Difference (Net)|1.72||||0.004||95.0|0.56|2.88|||ANCOVA|||Trochanter subgroup|
1746041|NCT00397839|3209069|Superiority or Other||Mean Difference (Net)|1.43||||0.012||95.0|0.32|2.55|||ANCOVA|||Femoral Neckm subgroup|
1746042|NCT00397839|3209069|Superiority or Other||Mean Difference (Net)|2.13|||<|0.001||95.0|1.34|2.92|||ANCOVA|||Total Hip subgroup|
1746043|NCT00397839|3209070|Superiority or Other||Mean Difference (Net)|0.86||||0.118||95.0|-0.22|1.94|||ANCOVA||||
1746044|NCT00397839|3209071|Superiority or Other||Mean Difference (Net)|2.58|||<|0.001||95.0|1.41|3.76|||ANCOVA||||
1746045|NCT00397631|3209077|Superiority or Other||Mean Difference (Net)|-44.7|Standard Error of the Mean|6.37|<|0.001||95.0|-57.2|32.2|||ANCOVA|Model terms: treatment, baseline 2-hour PPG|||
1746046|NCT00397631|3209078|Superiority or Other||Mean Difference (Net)|-22.8|Standard Error of the Mean|3.87|<|0.001||95.0|-30.4|-15.2|||ANCOVA|Model terms: treatment, baseline FPG|||
1746047|NCT00397631|3209079|Superiority or Other||Mean Difference (Net)|-0.89|Standard Error of the Mean|0.12|<|0.001||95.0|-1.13|-0.65|||ANCOVA|Model terms: treatment, baseline HbA1c|||
1746048|NCT00397189|3209139|Superiority or Other||Mean Difference (Final Values)|-15.6|Standard Deviation|47.0|<|0.05|2-Sided|95.0|-25.3|-6.0|||ANCOVA|||The analysis was a comparison of sleep latency as measured by the sleep diary at Visit 3 in the ITT 65-80 population, using a linear regression model with terms for treatment (Circadin® 2mg vs. Placebo) and baseline sleep latency.|
1746049|NCT00397150|3209140|Superiority or Other||Prevalence ratio|1.72|||||2-Sided|95.0|1.12|2.63|||||||
1746050|NCT00397150|3209141|Superiority or Other||Prevalence ratio|1.89|||||2-Sided|95.0|1.7|2.11|||||||
1746051|NCT00397150|3209146|Superiority or Other||Prevalence ratio|2.29|||||2-Sided|95.0|1.33|3.92|||||||
1746052|NCT00397033|3209151|Superiority or Other||LS Mean Difference|-2.8|Standard Error of the Mean|1.5||0.066||95.0|-5.8|0.2|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746053|NCT00397033|3209151|Superiority or Other||LS Mean Difference|-6.8|Standard Error of the Mean|1.6|<|0.001||95.0|-9.9|-3.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746054|NCT00397033|3209153|Superiority or Other||LS Means Difference|-0.4|Standard Error of the Mean|0.2||0.029||95.0|-0.7|0.0|||ANOVA|P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746055|NCT00397033|3209153|Superiority or Other||LS Means Difference|-0.7|Standard Error of the Mean|0.2|<|0.001||95.0|-1.1|-0.4|||ANOVA|P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher Scores indicate worsening.||
1746056|NCT00397033|3209154|Superiority or Other||LS Means Difference|-3.6|Standard Error of the Mean|2.7||0.187||95.0|-9.0|1.8||The Hochberg step-up procedure was used to address multiplicity.|ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.|One of the primary pairwise comparisons was paliperidone ER low dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|
1746074|NCT00397033|3209165|Superiority or Other||LS Mean Difference|-0.5|Standard Error of the Mean|0.6||0.43||95.0|-1.7|0.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746057|NCT00397033|3209154|Superiority or Other||LS Means Difference|-8.3|Standard Error of the Mean|2.8||0.003||95.0|-13.8|-2.9||The Hochberg step-up procedure was used to address multiplicity.|ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.|One of the primary pairwise comparisons was paliperidone ER high dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|
1746058|NCT00397033|3209155|Superiority or Other||LS Means Difference|-0.3|Standard Error of the Mean|0.2||0.083||95.0|-0.6|0.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746059|NCT00397033|3209155|Superiority or Other||LS Means Difference|-0.6|Standard Error of the Mean|0.2|<|0.001||95.0|-0.9|-0.3|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746060|NCT00397033|3209157|Superiority or Other||LS Mean Difference|-0.8|Standard Error of the Mean|0.5||0.099||95.0|-1.7|0.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746061|NCT00397033|3209157|Superiority or Other||LS Mean Difference|-0.8|Standard Error of the Mean|0.5||0.071||95.0|-1.8|0.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746062|NCT00397033|3209158|Superiority or Other||LS Mean Difference|-0.6|Standard Error of the Mean|0.6||0.314||95.0|-1.7|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746063|NCT00397033|3209158|Superiority or Other||LS Mean Difference|-2.1|Standard Error of the Mean|0.6|<|0.001||95.0|-3.2|-1.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746064|NCT00397033|3209159|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|0.6||0.269||95.0|-1.9|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746065|NCT00397033|3209159|Superiority or Other||LS Mean Difference|-1.8|Standard Error of the Mean|0.6||0.004||95.0|-3.1|-0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746066|NCT00397033|3209160|Superiority or Other||LS Mean Difference|-0.6|Standard Error of the Mean|0.6||0.31||95.0|-1.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746067|NCT00397033|3209160|Superiority or Other||LS Mean Difference|-0.7|Standard Error of the Mean|0.6||0.232||95.0|-2.0|0.5|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746068|NCT00397033|3209161|Superiority or Other||LS Mean Difference|-3.8|Standard Error of the Mean|1.5||0.013||95.0|-6.8|-0.8|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746069|NCT00397033|3209161|Superiority or Other||LS Mean Difference|-3.4|Standard Error of the Mean|1.6||0.032||95.0|-6.5|-0.3|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746070|NCT00397033|3209163|Superiority or Other||LS Mean Difference|-1.1|Standard Error of the Mean|0.9||0.209||95.0|-2.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746071|NCT00397033|3209163|Superiority or Other||LS Mean Difference|-2.9|Standard Error of the Mean|0.9||0.001||95.0|-4.6|-1.1|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746072|NCT00397033|3209164|Superiority or Other||LS Mean Difference|-2.0|Standard Error of the Mean|1.4||0.175||95.0|-4.8|0.9|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746073|NCT00397033|3209164|Superiority or Other||LS Mean Difference|-3.9|Standard Error of the Mean|1.5||0.008||95.0|-6.7|-1.0|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746139|NCT00395876|3209375|Superiority or Other||Mean Difference (Final Values)|24.9||||0.0093||95.0|7.1|42.6||Stratified by baseline weight (< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel||||
1746075|NCT00397033|3209165|Superiority or Other||LS Means Difference|-1.0|Standard Error of the Mean|0.6||0.108||95.0|-2.3|0.2|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746076|NCT00397033|3209166|Superiority or Other||LS Means Difference|-1.1|Standard Error of the Mean|0.9||0.217||95.0|-2.8|0.6|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746077|NCT00397033|3209166|Superiority or Other||LS Means Difference|-3.4|Standard Error of the Mean|0.9|<|0.001||95.0|-5.1|-1.7|||ANCOVA|P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.|Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.||
1746078|NCT00397033|3209167|Superiority or Other|||||||0.008|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.|||
1746079|NCT00397033|3209167|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel|P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.|||
1746080|NCT00396981|3209183|Non-Inferiority or Equivalence|This study used a non-inferiority design to demonstrate that the Matrix Coil is non-inferior to the GDC Coil, with a clinically acceptable non-inferiority margin set at 10%. Non-inferiority was used to establish the baseline estimate, which future superiority studies could be conducted. Non-inferiority was shown with a one-sided 95% CI of the difference less than the pre-specified 10% margin||||||0.76|||||||Log Rank|||Intent-to-Treat, All Subjects (N=626) GDC (N=315) Matrix (N=311) All Subjects (N=626) Subjects Who Met Primary Endpoint 35 (11.1%) 34 (10.9%) 69 (11.0%)|
1746081|NCT00396877|3209186|Superiority or Other||Relative Risk Reduction (%)|11.1||||0.434|2-Sided|95.0|-19.2|33.6||The a-priori threshold for statistical significance was < 0.035 reflecting the adjustment for interim analyses. No other adjustment for multiplicity was made.|Log Rank|A two-sided log-rank test was used.|The Relative Risk Reduction (Clopidogrel versus placebo) and its corresponding 95% confidence interval were estimated using Cox's proportional hazards model.|"Due to the limited knowledge in this population, 3 interim analyses were performed at approximatively 40%, 60%, 80% and 100% of of the maximum number of 172 required primary efficacy events to evaluate the effect of Clopidogrel on the primary endpoint with the potential to end the trial in case of a clear efficacy advantage for Clopidogrel.~The study was designed with 80% power and an overall type I error rate of 5%."|
1746082|NCT00396565|3209218|Superiority or Other||Least squares mean difference|-0.6|Standard Error of the Mean|0.13|<|0.0001||95.0|-0.84|-0.34|||ANCOVA|ANCOVA model with treatment as a factor, and baseline score as a covariate|||
1746083|NCT00396565|3209219|Superiority or Other|||||||0.0007|||||||Fisher Exact||||
1746084|NCT00396565|3209220|Superiority or Other||Least squares mean difference|-6.2|Standard Error of the Mean|1.21|<|0.0001||95.0|-8.58|-3.8|||ANCOVA|ANCOVA model with treatment as a factor, and with baseline score as a covariate|||
1746085|NCT00396565|3209221|Superiority or Other||Least squares mean difference|-2.5|Standard Error of the Mean|0.6|<|0.0001||95.0|-3.71|-1.33|||ANCOVA|ANCOVA model with treatment as a factor and with baseline score as a covariate|||
1746086|NCT00396565|3209222|Superiority or Other||Least squares mean difference|-3.8|Standard Error of the Mean|0.68|<|0.0001||95.0|-5.17|-2.51|||ANCOVA|ANCOVA model with treatment as a factor and with baseline score as a covariate.|||
1746087|NCT00396565|3209223|Superiority or Other||Least squares mean difference|-12.7|Standard Error of the Mean|2.26|<|0.0001||95.0|-17.16|-8.25|||ANCOVA|ANCOVA model with treatment as a factor and baseline score as a covariate|||
1746088|NCT00396162|3209308|Superiority or Other|||||||0.31|||||||t-test, 2 sided||||
1746089|NCT00396162|3209309|Superiority or Other|||||||0.23|||||||t-test, 2 sided||||
1746090|NCT00396097|3209312|Superiority or Other||Mean Difference (Final Values)|-0.005|Standard Error of the Mean|0.095||0.9566|2-Sided|95.0|-0.192|0.181|||ANCOVA||||
1746091|NCT00396097|3209312|Superiority or Other||Mean Difference (Final Values)|0.013|Standard Error of the Mean|0.094||0.8926|2-Sided|95.0|-0.172|0.198|||ANCOVA||||
1746092|NCT00396097|3209312|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.081||0.2618|2-Sided|95.0|-0.068|0.249|||ANCOVA||||
1746093|NCT00396097|3209313|Superiority or Other||Mean Difference (Final Values)|34.443|Standard Error of the Mean|3.306|<|0.0001|2-Sided|95.0|27.936|40.951|||ANCOVA||||
1746094|NCT00396097|3209313|Superiority or Other||Mean Difference (Final Values)|48.517|Standard Error of the Mean|3.284|<|0.0001|2-Sided|95.0|42.054|54.98|||ANCOVA||||
1746095|NCT00396097|3209313|Superiority or Other||Mean Difference (Final Values)|36.899|Standard Error of the Mean|3.414|<|0.0001|2-Sided|95.0|30.181|43.618|||ANCOVA||||
1746096|NCT00396097|3209314|Superiority or Other||Mean Difference (Final Values)|3.204|Standard Error of the Mean|2.495||0.2001|2-Sided|95.0|-1.707|8.114|||ANCOVA||||
1746097|NCT00396097|3209314|Superiority or Other||Mean Difference (Final Values)|9.281|Standard Error of the Mean|2.471||0.0002|2-Sided|95.0|4.417|14.145|||ANCOVA||||
1746098|NCT00396097|3209314|Superiority or Other||Mean Difference (Final Values)|5.822|Standard Error of the Mean|2.25||0.0101|2-Sided|95.0|1.395|10.249|||ANCOVA||||
1746099|NCT00396097|3209315|Superiority or Other||Hazard Ratio (HR)|1.033||||0.8016|2-Sided|95.0|0.802|1.33|||Regression, Cox||||
1746100|NCT00396097|3209316|Superiority or Other|||||||0.627|||||||ANOVA (Levene's Test)||||
1746101|NCT00396097|3209317|Superiority or Other||Mean Difference (Final Values)|-0.006|Standard Error of the Mean|0.033||0.5762|1-Sided|97.5|-0.071||||ANCOVA|||The null hypothesis was that the individualized treatment arm was not superior to the standard treatment arm; alternative hypothesis that the individualized treatment arm was superior to the standard treatment arm with respect to the mean 24-month AOTD. Using a 2:1 randomization, a two sided sample t-test comparing the root AOTD between the 2 treatment arms with 80% power at a 5% level required 260 subjects. Assuming a 20% attrition rate, approximately 312 subjects were needed for this study.|
1746102|NCT00396084|3209328|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||EBA Days 2-7 for INH was compared to that of the pooled linezolid arms.|
1746103|NCT00396084|3209328|Superiority or Other|||||||0.42|||||||ANOVA|||The rate of fall in sputum cfu for the 3 treatment groups between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained from fitting the 6 sputum cfu values corresponding to days 2 through 7.|
1746104|NCT00396084|3209328|Superiority or Other|||||||0.25|||||||ANOVA|||Mean values EBA Days 2-7 for the 3 treatment groups were compared.|
1746105|NCT00396084|3209331|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Mean EBA 0-2 of INH was compared to pooled Linezolid once daily and Linezolid twice daily results.|
1746106|NCT00396084|3209331|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against Linezolid once daily using a simultaneous non-parametric procedure.|
1746107|NCT00396084|3209331|Superiority or Other||||||<|0.01|||||||ANOVA|||Mean values of EBA Days 0 to 2 for the 3 treatments groups were compared.|
1746108|NCT00396084|3209332|Superiority or Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Day 7. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.|
1746109|NCT00396084|3209332|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||Day 6. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.|
1746110|NCT00396084|3209332|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||Day 5. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.|
1746111|NCT00396084|3209332|Superiority or Other|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||Day 4. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.|
1746112|NCT00396084|3209332|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Day 3. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.|
1746113|NCT00396084|3209332|Superiority or Other|||||||0.018|||||||Wilcoxon (Mann-Whitney)|||Day 2. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.|
1746114|NCT00396084|3209332|Superiority or Other|||||||0.023|||||||Wilcoxon (Mann-Whitney)|||Day 1. Pooled sputum bacillary load data for patients in the linezolid arms were combined and compared to that of patients in the INH arm.|
1746115|NCT00396084|3209332|Superiority or Other||||||<|0.001|||||||ANOVA|||Mean adjusted aAUC for all 3 treatment groups over the 7 days of study drug administration|
1746116|NCT00396084|3209333|Superiority or Other|||||||0.036|||||||Wilcoxon (Mann-Whitney)|||EBA Days 2-7 for patients in the 3 fluoroquinolone groups were pooled and compared to bactericidal activity of patients in the INH arm.|
1746117|NCT00396084|3209333|Superiority or Other|||||||0.16|||||||ANOVA|||The rate of fall in sputum cfu for the 4 treatment groups between day 2 and day 7 of monotherapy was estimated by the slope of the linear regression obtained from fitting the 6 sputum cfu values corresponding to days 2 through 7.|
1746118|NCT00396084|3209333|Superiority or Other|||||||0.51|||||||ANOVA|||Mean values of EBA Days 2 to 7 for the 4 treatment groups were compared.|
1746119|NCT00396084|3209334|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against levofloxacin using a simultaneous non-parametric procedure.|
1746120|NCT00396084|3209334|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against moxifloxacin using a simultaneous non-parametric procedure.|
1746121|NCT00396084|3209334|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Two way comparison of INH against gatifloxacin using a simultaneous non-parametric procedure.|
1746122|NCT00396084|3209334|Superiority or Other|||||||0.05|||||||ANOVA|||Mean values of EBA Days 0 to 2 for the 4 treatment groups were compared.|
1746123|NCT00396084|3209338|Superiority or Other|||||||0.354|||||||Wilcoxon (Mann-Whitney)|||Day 7. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.|
1746124|NCT00396084|3209338|Superiority or Other|||||||0.091|||||||Wilcoxon (Mann-Whitney)|||Day 6. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.|
1746125|NCT00396084|3209338|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Day 5. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.|
1746126|NCT00396084|3209338|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)|||Day 4. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.|
1746127|NCT00396084|3209338|Superiority or Other|||||||0.012|||||||Wilcoxon (Mann-Whitney)|||Day 3. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.|
1746128|NCT00396084|3209338|Superiority or Other|||||||0.008|||||||Wilcoxon (Mann-Whitney)|||Day 2. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.|
1746129|NCT00396084|3209338|Superiority or Other|||||||0.041|||||||Wilcoxon (Mann-Whitney)|||Day 1. Pooled sputum bacillary load data for patients in the 3 fluoroquinolones arms were combined and compared to that of patients in the INH arm.|
1746130|NCT00396084|3209338|Superiority or Other||||||<|0.001|||||||ANOVA|||Mean adjusted aAUC for all 4 treatment groups over the 7 days of study drug administration|
1746131|NCT00396032|3209341|Superiority or Other|||||||0.0396||||||Stratified by baseline BFR: 0–199 mL/min, 200–274 mL/min, and 275–299 mL/min.|Cochran-Mantel-Haenszel||||
1746132|NCT00396032|3209343|Superiority or Other|||||||0.0035|||||||Chi-squared||||
1746133|NCT00396032|3209343|Superiority or Other|||||||0.0044||||||Stratified by baseline BFR: 0−199 mL/min, 200−274 mL/min, and 275−299 mL/min.|Cochran-Mantel-Haenszel||||
1746134|NCT00396006|3209351|Superiority or Other|||||||0.4375|||||||Wilcoxon signed rank||||
1746135|NCT00396006|3209352|Superiority or Other|||||||0.1875|||||||Wilcoxon signed rank test||||
1746136|NCT00396006|3209354|Superiority or Other||||||<|0.0001|||||||paired t-tests||||
1746137|NCT00396006|3209355|Superiority or Other||||||<|0.0001|||||||paired t-tests||||
1746138|NCT00396006|3209359|Superiority or Other|||||||0.0195|||||||Wilcoxon signed rank test||||
1746141|NCT00395876|3209377|Superiority or Other||Mean Difference (Final Values)|36.6||||0.0002||95.0|18.4|54.8||Stratified by baseline weight (< 30 kg, ≥ 30 kg)|Cochran-Mantel-Haenszel||||
1746142|NCT00395863|3209378|Superiority or Other||Mean Difference (Final Values)|33.72|Standard Deviation|48.5||0.0026||95.0|14.63|52.81||Mean difference of Multihance minus Magnevist|t-test, 2 sided||||
1746143|NCT00395863|3209379|Superiority or Other||Mean Difference (Final Values)|33.61|Standard Deviation|43.16||0.0008||95.0|16.75|50.47||Mean difference of Multihance minus Magnevist|t-test, 2 sided||||
1746144|NCT00395863|3209380|Superiority or Other||Mean Difference (Final Values)|32.77|Standard Deviation|48.51||0.0019||95.0|14.28|51.25||Mean difference of Multihance minus Magnevist|t-test, 2 sided||||
1746145|NCT00395863|3209381|Superiority or Other||Median Difference (Final Values)|25.04|Standard Deviation|37.37||0.02||95.0|12.41|37.67||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided||||
1746146|NCT00395863|3209382|Superiority or Other||Mean Difference (Final Values)|30.95|Standard Deviation|48.64||0.0027||95.0|16.57|45.33||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided||||
1746147|NCT00395863|3209383|Superiority or Other||Mean Difference (Final Values)|40.99|Standard Deviation|59.78||0.0062||95.0|20.72|61.26||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided||||
1746148|NCT00395863|3209384|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Deviation|0.19|<|0.0001||95.0|0.18|0.33||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided||||
1746149|NCT00395863|3209385|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Deviation|0.2|<|0.0001||95.0|0.22|0.38||Mean difference of Multihance minus Magnevist for change from baseline|t-test, 2 sided||||
1746150|NCT00395863|3209386|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Deviation|0.22|<|0.0001||95.0|0.14|0.3||Mean difference of MultiHance minus Magnevist for change from baseline|t-test, 2 sided||||
1746151|NCT00395863|3209387|Superiority or Other||||||<|0.0001||||||Reader 3|wilcoxon signed-rank test||||
1746152|NCT00395863|3209387|Superiority or Other||||||<|0.0001||||||Reader 2|wilcoxon signed-rank test||||
1746153|NCT00395863|3209387|Superiority or Other||||||<|0.0001||||||Reader 1|wilcoxon signed-rank test||||
1746154|NCT00395863|3209388|Superiority or Other|||||||0.0002||||||Reader 3|wilcoxon signed-rank test||||
1746155|NCT00395863|3209388|Superiority or Other|||||||0.001||||||Reader 2|wilcoxon signed-rank test||||
1746156|NCT00395863|3209388|Superiority or Other|||||||0.0001||||||Reader 1|wilcoxon signed-rank test||||
1746157|NCT00395863|3209389|Superiority or Other||||||<|0.0001||||||Reader 3|wilcoxon signed-rank test||||
1746158|NCT00395863|3209389|Superiority or Other||||||<|0.0001||||||Reader 2|wilcoxon signed-rank test||||
1746159|NCT00395863|3209389|Superiority or Other||||||<|0.0001||||||Reader 1|wilcoxon signed-rank test||||
1746160|NCT00395850|3209390|Superiority or Other||Mean Difference (Final Values)|1.5|||<|0.05||95.0|||||t-test, 2 sided||||
1746161|NCT00395850|3209391|Superiority or Other||Slope|-1.02|||<|0.05|||||||Repeated Measures Logistic Regression|Repeated Measures Generalized Linear Models on a Binomial distribution, thus a Repeated Measures Logistic Regression||Used placebo group as contrast to determine whether slopes of disulfiram groups differed from slope of placebo group data|
1746162|NCT00395746|3209392|Superiority or Other||Rate ratio|1.45||||||95.0|0.72|2.91||||||The relative risk for 'Symptoms only episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.|
1746163|NCT00395746|3209392|Superiority or Other||Rate ratio|1.48||||||95.0|0.69|3.17||||||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.|
1746164|NCT00395746|3209392|Superiority or Other||Rate ratio|1.62||||||95.0|0.85|3.07||||||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.|
1746165|NCT00395746|3209392|Superiority or Other||Rate ratio|1.8||||||95.0|0.92|3.54||||||The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.|
1746166|NCT00395746|3209392|Superiority or Other||Rate ratio|1.18||||||95.0|0.56|2.47||||||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.|
1746167|NCT00395746|3209392|Superiority or Other||Rate ratio|1.59||||||95.0|0.86|2.96||||||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.|
1746168|NCT00395746|3209393|Superiority or Other||Least Squares Mean|1.13||||||95.0|0.51|1.75||||||95% confidence interval for the mean difference (each liraglutide – SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed|
1746169|NCT00395746|3209393|Superiority or Other||Least Squares Mean|1.04||||||95.0|0.42|1.66||||||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746201|NCT00395538|3209462|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the baseline and the years 2 and 4 (combined) biopsy.||||||0.057||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746170|NCT00395746|3209394|Superiority or Other||Least Squares Mean|1.18|||<|0.0001||95.0|0.63|1.73||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."|
1746171|NCT00395746|3209394|Superiority or Other||Least Squares Mean|0.75|||<|0.0071||95.0|0.21|1.3||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."|
1746172|NCT00395746|3209395|Superiority or Other||Least Squares Mean|-7.11||||||95.0|-18.42|4.21||||||95% confidence interval for the mean difference (each liraglutide – SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746173|NCT00395746|3209395|Superiority or Other||Least Squares Mean|-13.3||||||95.0|-24.69|-1.9||||||95% confidence interval for the mean difference (each liraglutide – SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746174|NCT00395746|3209396|Superiority or Other||Least Squares Mean|6.67||||0.2359||95.0|-4.39|17.73||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."|
1746175|NCT00395746|3209396|Superiority or Other||Least Squares Mean|-11.37||||0.0433||95.0|-22.4|-0.34||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."|
1746176|NCT00395746|3209397|Superiority or Other||Least Squares Mean|-46.34||||||95.0|-58.49|-34.18||||||95% confidence interval for the mean difference (each liraglutide – SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746177|NCT00395746|3209397|Superiority or Other||Least Squares Mean|-34.49||||||95.0|-46.77|-22.22||||||95% confidence interval for the mean difference (each liraglutide – SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746178|NCT00395746|3209398|Superiority or Other||Least Squares Mean|-34.3|||<|0.0001||95.0|-45.06|-23.54||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."|
1746179|NCT00395746|3209398|Superiority or Other||Least Squares Mean|-44.45|||<|0.0001||95.0|-55.02|-33.89||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."|
1746180|NCT00395746|3209399|Superiority or Other||Least Squares Mean|-68.68||||||95.0|-108.91|-28.45||||||95% confidence interval for the mean difference (each liraglutide – SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746181|NCT00395746|3209399|Superiority or Other||Least Squares Mean|-127.57||||||95.0|-166.91|-88.24||||||95% confidence interval for the mean difference (each liraglutide - SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746305|NCT00395512|3209535|Superiority or Other||LS Mean Difference|-0.4|||<|0.001|2-Sided|95.0|-0.63|-0.18||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA||||
1746618|NCT00391274|3210133|Superiority or Other|||||||0.7704|||||||Log Rank||||
1746182|NCT00395746|3209400|Superiority or Other||Least Squares Mean|-111.15|||<|0.0001||95.0|-147.61|-74.68||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."|
1746183|NCT00395746|3209400|Superiority or Other||Least Squares Mean|-150.22|||<|0.0001||95.0|-186.32|-114.12||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively."|
1746184|NCT00395746|3209401|Superiority or Other||Least Squares Mean|-24.4||||||95.0|-33.8|-14.9||||||95% confidence interval for the mean difference (each liraglutide – SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746185|NCT00395746|3209401|Superiority or Other||Least Squares Mean|-30.2||||||95.0|-39.6|-20.7||||||95% confidence interval for the mean difference (each liraglutide – SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746186|NCT00395746|3209402|Superiority or Other||Least Squares Mean|-26.4|||<|0.0001||95.0|-34.5|-18.2||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.|
1746187|NCT00395746|3209402|Superiority or Other||Least Squares Mean|-32.4|||<|0.0001||95.0|-40.5|-24.2||To perform the pairwise comparisons simultaneously, a closed testing procedure was applied. When the hypothesis μ0.9 = μ0.6 = μSU was rejected, the 2 hypotheses of pairwise comparison were tested simultaneously both at significance level of 5%.|ANOVA|||ANOVA model included treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate. Two null hypotheses were statistically tested, when the hypothesis μ0.9 = μ0.6 = μSU was rejected at a significance level of 5%: H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively.|
1746188|NCT00395746|3209403|Superiority or Other||Least Squares Mean|-0.96||||||95.0|-1.25|-0.67||||||95% confidence interval for the mean difference (each liraglutide – SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746189|NCT00395746|3209403|Superiority or Other||Least Squares Mean|-1.33||||||95.0|-1.62|-1.04||||||95% confidence interval for the mean difference (each liraglutide – SU monotherapy) was calculated under an analysis of variance (ANOVA) model with treatment group and pre-trial SU as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746190|NCT00395746|3209404|Superiority or Other||Least Squares Mean|-1.0|||<|0.0001||95.0|-1.24|-0.75|||ANOVA|A significance level of a two-sided 5% was used for statistical hypothesis testing.||"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed."|
1746191|NCT00395746|3209404|Superiority or Other||Least Squares Mean|-1.27|||<|0.0001||95.0|-1.51|1.02||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||"ANOVA model included treatment group and pre-trial SU as fixed effects and HbA1C at baseline as a covariate. Two null hypotheses were statistically tested:~H10: μ0.9 = μSU, H11: μ0.9 ≠ μSU H20: μ0.6 = μSU, H21: μ0.6 ≠ μSU where μ0.6, μ0.9 and μSU are population mean after 24-week treatment for 0.6 mg+SU, 0.9 mg+SU and SU mono, respectively. When the test of comparison between 0.9 mg+SU and SU mono was significant, the test of comparison between 0.6 mg+SU and SU mono was performed."|
1746192|NCT00395733|3209413|Non-Inferiority or Equivalence|Estimates for blinded reader 3 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.8698||||||90.0|0.78|0.9657|||||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.|
1746754|NCT00388297|3210524|Superiority or Other||Hodges–Lehmann|-1.0||||0.64|2-Sided|95.0|-3.0|2.0|||Chi-squared||||
1746193|NCT00395733|3209413|Non-Inferiority or Equivalence|Estimates for blinded reader 2 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.9458||||||90.0|0.8776|1.024|||||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.|
1746194|NCT00395733|3209413|Non-Inferiority or Equivalence|Estimates for blinded reader 1 only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.954||||||90.0|0.9122|0.9965|||||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.|
1746195|NCT00395733|3209413|Non-Inferiority or Equivalence|Estimates for investigators only. A non-inferiority margin of 15% was assumed. Based on 60 pairs of observations in a crossover design (15 participants with 10 vessels segments, 15 participants with 6 vessels segments and 30 participants with 17 vessels segments to be visualized and assessed) and non-inferiority testing based the lower limit of Fieller's one-sided 95% confidence interval for the ratio Gadavist / Magnevist of the means, the power was at least 80% under realistic assumptions.|Ratio of means|0.9736||||||90.0|0.9315|1.0168|||||For the estimation, only vessel segments with vascular assessments available for both periods were considered. The lower limit of the 95% one-sided Fieller-type confidence interval was compared with the non-inferiority margin 0.85.|Non-inferiority analysis: The aim was to show that Gadavist is not inferior (i.e. similar or better) to Magnevist in visualizing different vascular regions of the body with diagnostic quality in contrast enhanced MRA. Gadavist was to be considered to be non-inferior to Magnevist if the mean number of vessel segments visualized with diagnostic quality of Gadavist enhanced-MRA images was higher than 85% of that of Magnevist enhanced-MRA images in a cross-over design.|
1746196|NCT00395694|3209425|Superiority or Other||Percentage of participants|4.9|||||2-Sided|95.0|1.6|11.1|||||The estimated value represents the percentage of participants with rash events.||
1746197|NCT00395538|3209461|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.449||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746198|NCT00395538|3209461|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the year 1 and the years 2 and 4 (combined) biopsy.||||||0.342||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746199|NCT00395538|3209461|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium High between the baseline and the year 1 biopsy.||||||0.922||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium High as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746200|NCT00395538|3209462|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.547||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746299|NCT00395512|3209533|Superiority or Other||LS Mean Difference|-24.5|||<|0.001|2-Sided|95.0|-33.5|-15.4|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.|
1746755|NCT00388297|3210524|Superiority or Other||Hodges–Lehmann|0.0||||0.9|2-Sided|95.0|-2.0|3.0|||Chi-squared||||
1746202|NCT00395538|3209462|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Low between the baseline and the year 1 biopsy.||||||0.082||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Low as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746203|NCT00395538|3209463|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.787||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746204|NCT00395538|3209463|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the baseline and the years 2 and 4 (combined) biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746205|NCT00395538|3209463|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Width between the baseline and the year 1 biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Width as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746206|NCT00395538|3209464|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.434||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746207|NCT00395538|3209464|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the baseline and the years 2 and 4 (combined) biopsy.||||||0.194||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746208|NCT00395538|3209464|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Peak between the baseline and the year 1 biopsy.||||||0.227||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Peak as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746209|NCT00395538|3209465|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.764||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746210|NCT00395538|3209465|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the baseline and the years 2 and 4 (combined) biopsy.||||||0.11||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746300|NCT00395512|3209533|Superiority or Other||LS Mean Difference|-12.9|||<|0.006|2-Sided|95.0|-22.0|-3.8|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.|
1746306|NCT00395512|3209535|Superiority or Other||LS Mean Difference|-0.75|||<|0.001|2-Sided|95.0|-0.98|-0.53||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA||||
1746211|NCT00395538|3209465|Other|A contrast statement within the mixed models analysis tested for differences in the Cortex 1 Spectral Calcium Mean between the baseline and the year 1 biopsy.||||||0.02||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with Cortex 1 Spectral Calcium Mean as the dependent variable; biopsy year (baseline, year 1, and years 2 and 4 combined) as the independent variable; study cohort as a covariate; and a random effect for participant. No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746212|NCT00395538|3209466|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.338||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746213|NCT00395538|3209466|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.58||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746214|NCT00395538|3209466|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.AjAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.AjAR values for both their baseline and year 1 biopsies.||||||0.651||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746215|NCT00395538|3209467|Equivalence|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.789||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746216|NCT00395538|3209467|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746217|NCT00395538|3209467|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.ES/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.ES/BS values for both their baseline and year 1 biopsies.|||||<|0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746218|NCT00395538|3209468|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.328||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746377|NCT00394901|3209673|Superiority or Other||Odds Ratio (OR)|2.5||||0.0393||95.0|1.05|5.96|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746219|NCT00395538|3209468|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746220|NCT00395538|3209468|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.OS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.OS/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746221|NCT00395538|3209469|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.535||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746222|NCT00395538|3209469|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.486||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746223|NCT00395538|3209469|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.MAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.MAR values for both their baseline and year 1 biopsies.||||||0.202||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746224|NCT00395538|3209470|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.288||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746225|NCT00395538|3209470|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.023||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746226|NCT00395538|3209470|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.O.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.O.Th values for both their baseline and year 1 biopsies.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746227|NCT00395538|3209471|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.974||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746228|NCT00395538|3209471|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746229|NCT00395538|3209471|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.AjAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 3 participants with non-missing Ec.AjAR values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746230|NCT00395538|3209472|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.325||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746231|NCT00395538|3209472|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.009||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746232|NCT00395538|3209472|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.ES/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.ES/BS values for both their baseline and year 1 biopsies.||||||0.088||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746233|NCT00395538|3209473|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.104||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746234|NCT00395538|3209473|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746750|NCT00388297|3210523|Superiority or Other||Hodges–Lehmann|0.0||||0.91|2-Sided|95.0|-4.0|0.0|||Chi-squared|||Analysis for Recognition of Pictures|
1746235|NCT00395538|3209473|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.OS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.OS/BS values for both their baseline and year 1 biopsies.|||||<|0.029||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746236|NCT00395538|3209474|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.712||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746237|NCT00395538|3209474|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746238|NCT00395538|3209474|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.MAR between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.MAR values for both their baseline and year 1 biopsies.||||||0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746239|NCT00395538|3209475|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.67||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746240|NCT00395538|3209475|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.006||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746241|NCT00395538|3209475|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.O.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.O.Th values for both their baseline and year 1 biopsies.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746242|NCT00395538|3209476|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.228||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746243|NCT00395538|3209476|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.022||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746244|NCT00395538|3209476|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.AjAR between the baseline and the year 1 biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.AjAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746245|NCT00395538|3209477|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.02||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746246|NCT00395538|3209477|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746247|NCT00395538|3209477|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.ES/BS between the baseline and the year 1 biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.ES/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746248|NCT00395538|3209478|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.01||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746249|NCT00395538|3209478|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746250|NCT00395538|3209478|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.OS/BS between the baseline and the year 1 biopsy.|||||<|0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.OS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746301|NCT00395512|3209533|Superiority or Other||LS Mean Difference|-11.2|||<|0.017|2-Sided|95.0|-20.3|-2.0|||ANCOVA|P-value is from an ANCOVA model with treatment and geographic region as class variables and Baseline fasting plasma glucose as covariate.||Comparison of change from Baseline in fasting plasma glucose at Week 26 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.|
1746251|NCT00395538|3209479|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.904||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746252|NCT00395538|3209479|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the baseline and the years 2 and 4 (combined) biopsy.||||||0.004||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746253|NCT00395538|3209479|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.MAR between the baseline and the year 1 biopsy.||||||0.006||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MAR at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746254|NCT00395538|3209480|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.68||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746255|NCT00395538|3209480|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746256|NCT00395538|3209480|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.O.Th between the baseline and the year 1 biopsy.|||||<|0.003||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.O.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746257|NCT00395538|3209481|Other|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.282||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746258|NCT00395538|3209481|Other|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the baseline and the years 2 and 4 (combined) biopsy.||||||0.895||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746302|NCT00395512|3209534|Superiority or Other||LS Mean Difference|-0.73|||<|0.001|2-Sided|95.0|-0.94|-0.51|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Alogliptin 25 mg and Alogliptin 25 mg + Pioglitazone 30 mg.|
1746756|NCT00388297|3210525|Superiority or Other||Hodges–Lehmann|-1.0||||0.48|2-Sided|95.0|-3.0|2.0|||Chi-squared||||
1746259|NCT00395538|3209481|Other|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.Ar between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Po.Ar values for both their baseline and year 1 biopsies.||||||0.166||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746260|NCT00395538|3209482|Other|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.57||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746261|NCT00395538|3209482|Other|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the baseline and the years 2 and 4 (combined) biopsy.||||||0.76||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746262|NCT00395538|3209482|Other|A contrast statement within the mixed models analysis tested for differences in the Ct.Ar between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Ar values for both their baseline and year 1 biopsies.||||||0.358||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Ar at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746263|NCT00395538|3209483|Other|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.269||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Ct.Th change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Ct.Th, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).|
1746264|NCT00395538|3209483|Other|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.334||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746265|NCT00395538|3209483|Other|A contrast statement within the mixed models analysis tested for differences in the Ct.Th between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Th values for both their baseline and year 1 biopsies.||||||0.043||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746266|NCT00395538|3209484|Other|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.608||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1749524|NCT00360334|3214292|Superiority or Other|||||||0.65|||||||ANCOVA||||
1746267|NCT00395538|3209484|Other|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the baseline and the years 2 and 4 (combined) biopsy.||||||0.025||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746268|NCT00395538|3209484|Other|A contrast statement within the mixed models analysis tested for differences in the Tb.Sp between the baseline and the year 1 biopsy.||||||0.013||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Sp at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746269|NCT00395538|3209485|Other|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.843||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).|
1746270|NCT00395538|3209485|Other|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the baseline and the years 2 and 4 (combined) biopsy.||||||0.017||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).|
1746271|NCT00395538|3209485|Other|A contrast statement within the mixed models analysis tested for differences in the Tb.N between the baseline and the year 1 biopsy.||||||0.019||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Tb.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Tb.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).|
1746272|NCT00395538|3209486|Other|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.73||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746273|NCT00395538|3209486|Other|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the baseline and the years 2 and 4 (combined) biopsy.||||||0.944||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746274|NCT00395538|3209486|Other|A contrast statement within the mixed models analysis tested for differences in the Tb.Th between the baseline and the year 1 biopsy.||||||0.72||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Tb.Th at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746303|NCT00395512|3209534|Superiority or Other||LS Mean Difference|-0.52|||<|0.001|2-Sided|95.0|-0.74|-0.3|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 25 mg + Pioglitazone 30 mg.|
1746473|NCT00394836|3209728|Superiority or Other||percentage of responders|13.0|||||2-Sided|95.0|4.0|31.0|||||Response rate is calculated as the number of responses divided by the number of participants treated * 100.||
1746275|NCT00395538|3209487|Equivalence|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.155||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746276|NCT00395538|3209487|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.018||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746277|NCT00395538|3209487|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.MS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.MS/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746278|NCT00395538|3209488|Equivalence|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.172||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746279|NCT00395538|3209488|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.022||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746280|NCT00395538|3209488|Other|A contrast statement within the mixed models analysis tested for differences in the Ic.BFR/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ic.BFR/BS values for both their baseline and year 1 biopsies.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ic.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746281|NCT00395538|3209489|Equivalence|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.178||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746282|NCT00395538|3209489|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746751|NCT00388297|3210523|Superiority or Other||Hodges–Lehmann|0.0||||0.52|2-Sided|95.0|-6.0|0.0|||Chi-squared|||Analysis for Recognition of Pictures|
1746283|NCT00395538|3209489|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.MS/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.MS/BS values for both their baseline and year 1 biopsies.||||||0.031||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746284|NCT00395538|3209490|Equivalence|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.164||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746285|NCT00395538|3209490|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.||||||0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746286|NCT00395538|3209490|Other|A contrast statement within the mixed models analysis tested for differences in the Ec.BFR/BS between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ec.BFR/BS values for both their baseline and year 1 biopsies.||||||0.083||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ec.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746287|NCT00395538|3209491|Equivalence|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.168||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746288|NCT00395538|3209491|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746289|NCT00395538|3209491|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.MS/BS between the baseline and the year 1 biopsy.|||||<|0.002||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.MS/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746290|NCT00395538|3209492|Equivalence|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.374||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746752|NCT00388297|3210523|Superiority or Other||Hodges–Lehmann|0.0||||0.22|2-Sided|95.0|-8.0|0.0|||Chi-squared|||Analysis for recall of digits forward|
1746291|NCT00395538|3209492|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the baseline and the years 2 and 4 (combined) biopsy.|||||<|0.001||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746292|NCT00395538|3209492|Other|A contrast statement within the mixed models analysis tested for differences in the Cn.BFR/BS between the baseline and the year 1 biopsy.|||||<|0.009||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|A baseline covariate not added to model since it would over-parameterize the model.||Mixed models analysis: Cn.BFR/BS at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746293|NCT00395538|3209493|Equivalence|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.538||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.N at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746294|NCT00395538|3209493|Other|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the baseline and the years 2 and 4 (combined) biopsy.||||||0.129||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Ct.Po.N change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Ct.Po.N, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).|
1746295|NCT00395538|3209493|Other|A contrast statement within the mixed models analysis tested for differences in the Ct.Po.N between the baseline and the year 1 biopsy. P-value interpretation is questionable since there were only 4 participants with non-missing Ct.Po.N values for both their baseline and year 1 biopsies.||||||0.371||||||No adjustments were made for multiple comparisons, because the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Ct.Po.N at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, model covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2 (using a Cohort 2 indicator variable). No bone biopsy baseline covariate included since it would over-parameterize the model.|
1746296|NCT00395538|3209494|Equivalence|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the year 1 biopsy and the years 2 and 4 (combined) biopsy.||||||0.649||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis was performed with: Cn.BV/TV change from baseline at biopsy year 1 or years 2 and 4 combined as the dependent variable; biopsy year, and baseline Cn.BV/TV, as model covariates; and a random effect for participant. Since Cohort 2 had a time delay of 30 to 31 months from the baseline biopsy to start of HPTH therapy, this time delay (centered to stabilize variance) was added as a covariate to the model for Cohort 2 only (using a Cohort 2 indicator variable).|
1746297|NCT00395538|3209494|Other|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the baseline and the years 2 and 4 (combined) biopsy.||||||0.002||||||No adjustments were made for multiple comparisons, because the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BV/TV at biopsy baseline, year 1, and years 2 and 4 combined as the dependent variable; biopsy year as the independent variable, covariates for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2. No bone biopsy baseline covariate included because it would over-parameterize the model.|
1746298|NCT00395538|3209494|Other|A contrast statement within the mixed models analysis tested for differences in the cn.BV/TV between the baseline and the year 1 biopsy.||||||0.015||||||No adjustments were made for multiple comparisons, since the study was terminated early resulting in only 5, 5, and 2 participants having their biopsies at 1, 2, and 4 years respectively.|Mixed Models Analysis|||Mixed models analysis: Cn.BV/TV at biopsy baseline, year 1, 2 & 4 combined as the dependent variable; biopsy year as the independent variable, covariate for Cohort; and a random effect for participant. Since Cohort 2 had a time delay from the baseline biopsy to start of HPTH therapy, this time delay (centered) was added as a covariate for Cohort 2. No bone biopsy baseline covariate was included because it would over-parameterize the model.|
1746304|NCT00395512|3209534|Superiority or Other||LS Mean Difference|-0.33|||<|0.003|2-Sided|95.0|-0.55|-0.12|||ANCOVA|ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.||Comparison of change from Baseline at Week 20 between Pioglitazone 30 mg and Alogliptin 12.5 mg + Pioglitazone 30 mg.|
1746307|NCT00395512|3209535|Superiority or Other||LS Mean Difference|-0.56|||<|0.001|2-Sided|95.0|-0.78|-0.33||ANCOVA model with treatment and geographic region as class variables and baseline HbA1c as a covariate.|ANCOVA|||The primary efficacy variable was defined as change from Baseline in HbA1c level at Week 26. The null hypothesis was that the average change from Baseline in HbA1c at Week 26 for the A25 + P30 group would be equal to the average changes for the P30 alone and A25 alone groups; further, under the null hypothesis, the average change from Baseline in HbA1c at Week 26 for the A12.5 + P30 group was equal to the average change for the P30 alone group.|
1746308|NCT00395460|3209556|Non-Inferiority or Equivalence|The analysis was performed by means of a Confidence Interval (CI) approach: noninferiority of Gadavist was assumed if the one-sided 95% CI for pGadavist-pMagnevist was lying entirely to the right of the value -delta, where p is the estimated change in CNR and with pre-defined non-inferiority margin delta of 15% (=6.52 or 15% of 43.467).|Mean Difference (Final Values)|6.939|Standard Deviation|38.83|||1-Sided|95.0|-3.897||||||||
1746309|NCT00395343|3209558|Superiority or Other||Mean Difference (Net)|-0.56|||<|0.001||95.0|-0.72|-0.4|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum, treatment by insulin stratum interaction|||
1746310|NCT00395343|3209559|Superiority or Other||Odds Ratio (OR)|1.37||||0.584||95.0|0.45|4.18||Based on a test of the odds ratio = 1, comparing the odds of having A1C <7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|Logistic Regression|Model terms: treatment; baseline; Metformin stratum; and insulin stratum|This parameter estimate and 95% confidence interval correspond to the odds of having A1C <6.5% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.||
1746311|NCT00395343|3209560|Superiority or Other||Odds Ratio (OR)|3.6|||<|0.001||95.0|1.89|6.85||Based on a test of the odds ratio = 1, comparing the odds of having A1C <7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.|Logistic Regression|Model terms: treatment; baseline; Metformin stratum; and insulin stratum|||
1746312|NCT00395343|3209561|Superiority or Other||Geometric Mean Difference|36.5||||0.01||95.0|8.9|64.7|||ANCOVA|Model terms: treatment; log-scaled baseline value; metformin stratum; insulin stratum|||
1746313|NCT00395343|3209562|Superiority or Other||Mean Difference (Net)|-36.1|||<|0.001||95.0|-47.1|-25.1|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum|||
1746314|NCT00395343|3209563|Superiority or Other||Mean Difference (Net)|-15.0|||<|0.001||95.0|-23.4|-6.5|||ANCOVA|Model terms: treatment; baseline; metformin stratum; insulin stratum|||
1746315|NCT00395343|3209564|Superiority or Other||Mean Difference (Net)|-0.56|||<|0.001||95.0|-0.7|-0.42|||ANCOVA|Model terms: treatment; baseline; metformin stratum (on vs. not on metformin); insulin stratum (pre-mixed vs. intermediate or long-acting)|||
1746316|NCT00395291|3209579|Superiority or Other|||||||0.9|||||||ANCOVA|Total ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in Total-Ghrelin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."|
1746317|NCT00395291|3209580|Superiority or Other|||||||0.545|||||||ANCOVA|The adiponectin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in adiponectin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."|
1746318|NCT00395291|3209581|Superiority or Other|||||||0.875|||||||ANCOVA|The esterase data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in esterase is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."|
1746319|NCT00395291|3209582|Superiority or Other|||||||0.277|||||||ANCOVA|The IL-10 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-10 is the same for both the MK-0677 and placebo interventions.~Because IL-10 is considered as a secondary outcome, no power analysis was conducted."|
1746320|NCT00395291|3209583|Superiority or Other|||||||0.233|||||||ANCOVA||||
1746321|NCT00395291|3209584|Superiority or Other|||||||0.905|||||||ANCOVA|The IL-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IL-1 is the same for both the MK-0677 and placebo interventions.~Because IL-1 is considered as a secondary outcome, no power analysis was conducted"|
1746322|NCT00395291|3209585|Superiority or Other|||||||0.929|||||||ANCOVA|The CRPs data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in CRPs is the same for both the MK-0677 and placebo interventions.~Because CRPs is considered as a secondary outcome, no power analysis was conducted."|
1746323|NCT00395291|3209586|Superiority or Other|||||||0.385|||||||ANCOVA|The TNF-a data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in TNF-a is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."|
1746324|NCT00395291|3209587|Superiority or Other|||||||0.782|||||||ANCOVA||||
1746325|NCT00395291|3209588|Superiority or Other|||||||0.075|||||||ANCOVA|The insulin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in serum-insulin is the same for both the MK-0677 and placebo interventions.~Because serum-insulin is considered a secondary outcome, no power analysis was conducted."|
1746326|NCT00395291|3209589|Superiority or Other|||||||0.063|||||||ANCOVA|The Leptin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in leptin is the same for both the MK-0677 and placebo interventions.~Because Leptin is considered a secondary outcome, no power analysis was conducted."|
1746327|NCT00395291|3209590|Superiority or Other|||||||0.169|||||||ANCOVA|The Acyl-Ghrelin data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in Acyl-Ghrelin is the same for both the MK-0677 and placebo interventions.~Because Acyl-Ghrelin is considered as a secondary outcome, no power analysis was conducted."|
1746328|NCT00395291|3209591|Superiority or Other||||||<|0.001||||||The IGF-1 data were analyzed on the natural logarithmic scale via a linear mixed model in correspondence to a 2-period crossover design ANCOVA.|ANCOVA|||"Null hypothesis: the intra-subject pre-intervention to post-intervention change in IGF-1 is the same for both the MK-0677 and placebo interventions.~Power calculation: We assumed that the IGF-I data will be lognormally distributed and thus the parameter of interest will be the IGF-1 geometric mean. If n=22 individuals complete the study and the intervention effect is 48% greater for one intervention than the other we will have at least 0.80 power to reject the null hypothesis."|
1746329|NCT00395226|3209592|Superiority or Other||Mean Difference (Final Values)|0.57||||0.284|2-Sided|95.0|-0.47|1.62||The a priori significance threshold level was 0.05 (two-sided)|ANCOVA|The ANCOVA used group as a factor and baseline rosacea severity score as a covariate.|The effect of zinc sulfate treatment on rosacea severity score was estimated with baseline rosacea severity score included in the regression model|The null hypothesis was “no group differences.” The alternative hypothesis was that the zinc sulfate arm is superior to placebo arm.|
1746330|NCT00395161|3209593|Superiority or Other|||||||0.16|||||||Chi-squared||||
1746331|NCT00395161|3209594|Superiority or Other|||||||0.07|||||||Chi-squared||||
1746332|NCT00395161|3209595|Superiority or Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)||||
1746333|NCT00395161|3209596|Superiority or Other|||||||0.81|||||||Rate analysis (see comments)|95% CIs were calculated for rates in each arm, and rates compared between arms, via approach of DR Cox, Biometrika (1953), vol 40, pp. 354-60.||Null hypothesis of equal event rates in the two study arms.|
1746334|NCT00395161|3209597|Superiority or Other|||||||0.29|||||||Log Rank|Two-sided logrank test was used, stratified by immune compromised status at study entry (a factor also used to stratify the study randomization)||Null hypothesis was equal median time in both arms. Sample size calculated to yield 90% power to detect a significant effect, assuming inverse hazard rate of 1.5 using two-sided logrank test with alpha=0.05. This required recruitment until 263 patients with an event were enrolled (though the study was terminated early for futility by the DSMB).|
1746335|NCT00395135|3209598|Superiority or Other (legacy)||Difference in proportion (%)|1.64|||<|0.001|2-Sided|95.0|1.1|2.19|||ANCOVA||||
1746336|NCT00395135|3209598|Superiority or Other (legacy)||Difference in proportion (%)|-2.58|||<|0.001|2-Sided|95.0|-3.29|-1.88|||ANCOVA||||
1746337|NCT00395135|3209599|Superiority or Other (legacy)||Difference in proportion (%)|-3.67|||<|0.001|2-Sided|95.0|-4.09|-3.25|||ANCOVA||||
1746338|NCT00395135|3209601|Superiority or Other (legacy)||Odds Ratio (OR)|3.6|||<|0.0001|2-Sided|95.0|3.0|4.2|||ANCOVA||||
1746339|NCT00395083|3209602|Superiority or Other||Hazard Ratio (HR)|3.0||||0.002|2-Sided|95.0|1.46|6.17|||Log Rank||||
1746340|NCT00395083|3209603|Superiority or Other||Hazard Ratio (HR)|3.0||||0.003|2-Sided|95.0|1.46|6.17|||Regression, Cox||||
1746341|NCT00395083|3209604|Superiority or Other||Hazard Ratio (HR)|1.13||||0.62|2-Sided|95.0|0.7|1.8|||Regression, Cox||||
1746342|NCT00395083|3209605|Superiority or Other||Hazard Ratio (HR)|1.13||||0.62|2-Sided|95.0|0.7|1.8|||Log Rank||||
1746343|NCT00395044|3209617|Superiority or Other|||||||0.029|||||||Mixed Models Analysis||||
1746344|NCT00394953|3209639|Superiority or Other||Odds Ratio (OR)|2.63|||<|0.0001|2-Sided|95.0|1.83|3.79|||Chi-squared, Corrected|||The proportion of responders treated with methoxy polyethylene glycol-epoetin beta versus the proportion of responders treated with darbepoetin alpha during the evaluation period.|
1746345|NCT00394914|3209648|Superiority or Other|||||||0.425|||||||Cochran-Mantel-Haenszel||||
1746346|NCT00394914|3209649|Superiority or Other|||||||0.973|||||||Cochran-Mantel-Haenszel||||
1746347|NCT00394901|3209663|Superiority or Other||Mean Difference (Final Values)|-0.62||||0.012||95.0|-1.09|-0.14|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746348|NCT00394901|3209663|Superiority or Other||Mean Difference (Final Values)|-0.82||||0.001||95.0|-1.3|-0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746349|NCT00394901|3209663|Superiority or Other||Mean Difference (Final Values)|-0.27||||0.281||95.0|-0.76|0.22|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746350|NCT00394901|3209664|Superiority or Other||Mean Difference (Final Values)|-0.63||||0.01||95.0|-1.1|-0.15|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746351|NCT00394901|3209664|Superiority or Other||Mean Difference (Final Values)|-0.85||||0.001||95.0|-1.34|-0.37|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746352|NCT00394901|3209664|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.241||95.0|-0.78|0.2|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746353|NCT00394901|3209665|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.007||95.0|-1.13|-0.18|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746354|NCT00394901|3209665|Superiority or Other||Mean Difference (Final Values)|-0.94|||<|0.001||95.0|-1.43|-0.46|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746355|NCT00394901|3209665|Superiority or Other||Mean Difference (Final Values)|-0.24|||<|0.326||95.0|-0.73|0.24|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746356|NCT00394901|3209666|Superiority or Other||Mean Difference (Final Values)|-0.52||||0.031||95.0|-1.0|-0.05|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746357|NCT00394901|3209666|Superiority or Other||Mean Difference (Final Values)|-0.91|||<|0.001||95.0|-1.39|-0.42|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746358|NCT00394901|3209666|Superiority or Other||Mean Difference (Final Values)|-0.22|||<|0.364||95.0|-0.71|0.26|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746359|NCT00394901|3209667|Superiority or Other||Mean Difference (Final Values)|-0.58||||0.016||95.0|-1.06|-0.11|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746360|NCT00394901|3209667|Superiority or Other||Mean Difference (Final Values)|-0.87|||<|0.001||95.0|-1.35|-0.38|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746361|NCT00394901|3209667|Superiority or Other||Mean Difference (Final Values)|-0.21|||<|0.392||95.0|-0.7|0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746362|NCT00394901|3209668|Superiority or Other||Mean Difference (Final Values)|-0.58||||0.017||95.0|-1.05|-0.1|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746363|NCT00394901|3209668|Superiority or Other||Mean Difference (Final Values)|-0.82||||0.001||95.0|-1.3|-0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746364|NCT00394901|3209668|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.53||95.0|-0.64|0.33|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746365|NCT00394901|3209669|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.006||95.0|-1.14|-0.19|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746366|NCT00394901|3209669|Superiority or Other||Mean Difference (Final Values)|-0.9|||<|0.001||95.0|-1.38|-0.42|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746367|NCT00394901|3209669|Superiority or Other||Mean Difference (Final Values)|-0.24|||<|0.334||95.0|-0.72|0.25|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746368|NCT00394901|3209670|Superiority or Other||Mean Difference (Final Values)|-0.75||||0.002||95.0|-1.22|-0.28|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746369|NCT00394901|3209670|Superiority or Other||Mean Difference (Final Values)|-0.98|||<|0.001||95.0|-1.46|-0.5|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746370|NCT00394901|3209670|Superiority or Other||Mean Difference (Final Values)|-0.27|||<|0.275||95.0|-0.75|0.21|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746371|NCT00394901|3209671|Superiority or Other||Mean Difference (Final Values)|-0.74||||0.002||95.0|-1.22|-0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746372|NCT00394901|3209671|Superiority or Other||Median Difference (Final Values)|-0.87|||<|0.001||95.0|-1.35|-0.39|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746373|NCT00394901|3209671|Superiority or Other||Mean Difference (Final Values)|-0.14|||<|0.577||95.0|-0.62|0.35|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746374|NCT00394901|3209672|Superiority or Other||Mean Difference (Final Values)|-0.93|||<|0.001||95.0|-1.4|-0.46|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746375|NCT00394901|3209672|Superiority or Other||Mean Difference (Final Values)|-0.86|||<|0.001||95.0|-1.34|-0.38|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746376|NCT00394901|3209672|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.227||95.0|-0.78|0.18|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746753|NCT00388297|3210523|Superiority or Other||Hodges–Lehmann|0.0||||0.6|2-Sided|95.0|-5.0|7.0|||Chi-squared|||Analysis for recall of digits forward|
1746378|NCT00394901|3209673|Superiority or Other||Odds Ratio (OR)|2.64||||0.0353||95.0|1.07|6.53|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746379|NCT00394901|3209673|Superiority or Other||Odds Ratio (OR)|2.26||||0.0732||95.0|0.93|5.52|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746380|NCT00394901|3209674|Superiority or Other||Odds Ratio (OR)|2.01||||0.1787||95.0|0.73|5.58|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746381|NCT00394901|3209674|Superiority or Other||Odds Ratio (OR)|2.56||||0.0745||95.0|0.91|7.19|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746382|NCT00394901|3209674|Superiority or Other||Odds Ratio (OR)|1.28||||0.6451||95.0|0.45|3.59|||Regression, Logistic|treatment, CLcr stratum, and the presence of symptom at baseline as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746383|NCT00394901|3209675|Superiority or Other||Mean Difference (Final Values)|4.76||||0.079||95.0|-0.56|10.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746384|NCT00394901|3209675|Superiority or Other||Mean Difference (Final Values)|6.99||||0.012||95.0|1.58|12.4|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746385|NCT00394901|3209675|Superiority or Other||Mean Difference (Final Values)|3.99||||0.154||95.0|-1.5|9.49|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05|
1746386|NCT00394901|3209676|Superiority or Other||Mean Difference (Final Values)|4.15||||0.117||95.0|-1.05|9.34|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746387|NCT00394901|3209676|Superiority or Other||Mean Difference (Final Values)|7.42||||0.006||95.0|2.14|12.69|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746388|NCT00394901|3209676|Superiority or Other||Mean Difference (Final Values)|5.64||||0.039||95.0|0.29|11.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746389|NCT00394901|3209677|Superiority or Other||Mean Difference (Final Values)|3.02||||0.366||95.0|-3.55|9.6|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746390|NCT00394901|3209677|Superiority or Other||Mean Difference (Final Values)|5.41||||0.111||95.0|-1.25|12.08|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746391|NCT00394901|3209677|Superiority or Other||Mean Difference (Final Values)|6.15||||0.075||95.0|-0.63|12.92|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746392|NCT00394901|3209678|Superiority or Other||Mean Difference (Final Values)|1.83||||0.549||95.0|-4.18|7.85|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746393|NCT00394901|3209678|Superiority or Other||Mean Difference (Final Values)|7.41||||0.018||95.0|1.28|13.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746394|NCT00394901|3209678|Superiority or Other||Mean Difference (Final Values)|2.43||||0.443||95.0|-3.79|8.65|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746395|NCT00394901|3209679|Superiority or Other||Mean Difference (Final Values)|3.93||||0.058||95.0|-0.13|8.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746396|NCT00394901|3209679|Superiority or Other||Mean Difference (Final Values)|3.82||||0.07||95.0|-0.31|7.96|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746397|NCT00394901|3209679|Superiority or Other||Mean Difference (Final Values)|5.3||||0.013||95.0|1.1|9.5|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746398|NCT00394901|3209680|Superiority or Other||Mean Difference (Final Values)|5.03||||0.047||95.0|0.06|10.0|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746399|NCT00394901|3209680|Superiority or Other||Mean Difference (Final Values)|7.07||||0.006||95.0|2.03|12.12|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746400|NCT00394901|3209680|Superiority or Other||Mean Difference (Final Values)|0.62||||0.811||95.0|-4.5|5.75|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746534|NCT00393705|3209867|Superiority or Other|||||||0.0063||||||P-value for Nocturnal Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746401|NCT00394901|3209681|Superiority or Other||Mean Difference (Final Values)|1.46||||0.643||95.0|-4.74|7.66|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746402|NCT00394901|3209681|Superiority or Other||Mean Difference (Final Values)|6.67||||0.037||95.0|0.39|12.95|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746403|NCT00394901|3209681|Superiority or Other||Mean Difference (Final Values)|9.4||||0.004||95.0|3.01|15.78|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746404|NCT00394901|3209682|Superiority or Other||Mean Difference (Final Values)|1.04||||0.559||95.0|-2.45|4.53|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746405|NCT00394901|3209682|Superiority or Other||Mean Difference (Final Values)|0.77||||0.67||95.0|-2.78|4.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746406|NCT00394901|3209682|Superiority or Other||Mean Difference (Final Values)|3.51||||0.057||95.0|-0.1|7.13|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746407|NCT00394901|3209683|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746408|NCT00394901|3209683|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746409|NCT00394901|3209683|Superiority or Other||||||<|0.344|||||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746410|NCT00394901|3209684|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746411|NCT00394901|3209684|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746412|NCT00394901|3209684|Superiority or Other||||||<|0.0466|||||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746413|NCT00394901|3209685|Superiority or Other||Odds Ratio (OR)|1.54||||0.1893||95.0|0.81|2.95|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746414|NCT00394901|3209685|Superiority or Other||Odds Ratio (OR)|1.89||||0.0577||95.0|0.98|3.66|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746415|NCT00394901|3209685|Superiority or Other||Odds Ratio (OR)|0.68||||0.2842||95.0|0.34|1.37|||Regression, Logistic|treatment, CLcr stratum, and the optimal sleep score at baseline as covariate||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746416|NCT00394901|3209686|Superiority or Other||Mean Difference (Final Values)|-2.44||||0.24||95.0|-6.52|1.64|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746417|NCT00394901|3209686|Superiority or Other||Mean Difference (Final Values)|-3.2||||0.133||95.0|-7.37|0.98|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746418|NCT00394901|3209686|Superiority or Other||Mean Difference (Final Values)|-4.03||||0.061||95.0|-8.25|0.18|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746419|NCT00394901|3209687|Superiority or Other||Mean Difference (Final Values)|14.23|||<|0.001||95.0|8.5|19.95|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746420|NCT00394901|3209687|Superiority or Other||Mean Difference (Final Values)|11.21|||<|0.001||95.0|5.41|17.02|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746421|NCT00394901|3209687|Superiority or Other||Mean Difference (Final Values)|3.93|||<|0.191||95.0|-1.97|9.83|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746422|NCT00394901|3209688|Superiority or Other||Mean Difference (Final Values)|6.0||||0.106||95.0|-1.29|13.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746423|NCT00394901|3209688|Superiority or Other||Mean Difference (Final Values)|10.3||||0.007||95.0|2.87|17.73|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746424|NCT00394901|3209688|Superiority or Other||Mean Difference (Final Values)|4.01||||0.296||95.0|-3.52|11.55|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746425|NCT00394901|3209689|Superiority or Other||Mean Difference (Final Values)|0.21||||0.17||95.0|-0.09|0.52|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746537|NCT00393705|3209869|Superiority or Other|||||||0.5525||||||P-value for 2-Hours After Dinner.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746426|NCT00394901|3209689|Superiority or Other||Mean Difference (Final Values)|0.27||||0.084||95.0|-0.04|0.58|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746427|NCT00394901|3209689|Superiority or Other||Mean Difference (Final Values)|0.01||||0.955||95.0|-0.3|0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746428|NCT00394901|3209690|Superiority or Other||Mean Difference (Final Values)|-1.04||||0.641||95.0|-5.43|3.35|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746429|NCT00394901|3209690|Superiority or Other||Mean Difference (Final Values)|0.71||||0.754||95.0|-3.75|5.18|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746430|NCT00394901|3209690|Superiority or Other||Mean Difference (Final Values)|0.71||||0.76||95.0|-3.83|5.24|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746431|NCT00394901|3209691|Superiority or Other||Mean Difference (Final Values)|9.7||||0.007||95.0|2.67|16.74|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746432|NCT00394901|3209691|Superiority or Other||Mean Difference (Final Values)|2.95||||0.417||95.0|-4.2|10.11|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746433|NCT00394901|3209691|Superiority or Other||Mean Difference (Final Values)|4.29||||0.245||95.0|-2.95|11.54|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746434|NCT00394901|3209692|Superiority or Other||Mean Difference (Final Values)|-11.3|||<|0.001||95.0|-16.5|-6.22|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746435|NCT00394901|3209692|Superiority or Other||Mean Difference (Final Values)|-8.24|||<|0.002||95.0|-13.5|-2.99|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746436|NCT00394901|3209692|Superiority or Other||Mean Difference (Final Values)|-8.9|||<|0.001||95.0|-14.2|-3.61|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746437|NCT00394901|3209693|Superiority or Other||Mean Difference (Final Values)|-0.94|||<|0.001||95.0|-1.4|-0.49|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746438|NCT00394901|3209693|Superiority or Other||Mean Difference (Final Values)|-0.81|||<|0.001||95.0|-1.27|-0.34|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746439|NCT00394901|3209693|Superiority or Other||Mean Difference (Final Values)|-0.76|||<|0.001||95.0|-1.23|-0.3|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746440|NCT00394901|3209694|Superiority or Other||Mean Difference (Final Values)|-0.31||||0.03||95.0|-0.59|-0.03|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746441|NCT00394901|3209694|Superiority or Other||Mean Difference (Final Values)|-0.43||||0.003||95.0|-0.72|-0.15|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746442|NCT00394901|3209694|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.178||95.0|-0.48|0.09|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746443|NCT00394901|3209695|Superiority or Other||Mean Difference (Final Values)|-7.43||||0.013||95.0|-13.3|-1.59|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746444|NCT00394901|3209695|Superiority or Other||Mean Difference (Final Values)|-8.04||||0.008||95.0|-14.0|-2.06|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746445|NCT00394901|3209695|Superiority or Other||Mean Difference (Final Values)|-2.23||||0.47||95.0|-8.28|3.83|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746446|NCT00394901|3209696|Superiority or Other||Mean Difference (Final Values)|-2.61||||0.012||95.0|-4.65|-0.56|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746447|NCT00394901|3209696|Superiority or Other||Mean Difference (Final Values)|-2.55||||0.017||95.0|-4.64|-0.46|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746448|NCT00394901|3209696|Superiority or Other||Mean Difference (Final Values)|-0.83||||0.441||95.0|-2.93|1.28|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746535|NCT00393705|3209867|Superiority or Other|||||||0.723||||||P-value for Total Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746449|NCT00394901|3209697|Superiority or Other||Mean Difference (Final Values)|-0.61||||0.045||95.0|-1.21|-0.01|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746450|NCT00394901|3209697|Superiority or Other||Mean Difference (Final Values)|-0.71||||0.024||95.0|-1.32|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746451|NCT00394901|3209697|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.349||95.0|-0.91|0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746452|NCT00394901|3209698|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.012||95.0|-3.56|-0.44|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746453|NCT00394901|3209698|Superiority or Other||Mean Difference (Final Values)|-1.86||||0.023||95.0|-3.46|-0.26|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746454|NCT00394901|3209698|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.505||95.0|-2.16|1.06|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746455|NCT00394901|3209699|Superiority or Other||Mean Difference (Final Values)|-0.99|||<|0.001||95.0|-1.46|-0.52|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746456|NCT00394901|3209699|Superiority or Other||Mean Difference (Final Values)|-0.96|||<|0.001||95.0|-1.44|-0.48|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746457|NCT00394901|3209699|Superiority or Other||Mean Difference (Final Values)|-0.41|||<|0.096||95.0|-0.89|0.07|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746458|NCT00394901|3209700|Superiority or Other||Mean Difference (Final Values)|-1.03|||<|0.001||95.0|-1.49|-0.56|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746459|NCT00394901|3209700|Superiority or Other||Mean Difference (Final Values)|-0.99|||<|0.001||95.0|-1.47|-0.52|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746460|NCT00394901|3209700|Superiority or Other||Mean Difference (Final Values)|-0.48|||<|0.048||95.0|-0.97|0.0|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746461|NCT00394901|3209701|Superiority or Other||Mean Difference (Final Values)|-0.72||||0.002||95.0|-1.19|-0.26|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746462|NCT00394901|3209701|Superiority or Other||Mean Difference (Final Values)|-0.75||||0.002||95.0|-1.22|-0.27|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746463|NCT00394901|3209701|Superiority or Other||Mean Difference (Final Values)|-0.51||||0.038||95.0|-0.99|-0.03|||repeated measures analysis|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746464|NCT00394901|3209702|Superiority or Other|||||||0.0107|||||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746465|NCT00394901|3209702|Superiority or Other|||||||0.0015|||||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746466|NCT00394901|3209702|Superiority or Other|||||||0.116|||||||Cochran-Mantel-Haenszel|stratified by CLcr stratum||Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746467|NCT00394901|3209703|Superiority or Other||Mean Difference (Final Values)|-0.66||||0.008||95.0|-1.14|-0.17|||ANCOVA|The model included treatment group modified based on the expected pregabalin exposure as a factor, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746468|NCT00394901|3209703|Superiority or Other||Mean Difference (Final Values)|-0.64||||0.016||95.0|-1.16|-0.12|||ANCOVA|The model included treatment group modified based on the expected pregabalin exposure as a factor, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746469|NCT00394901|3209704|Superiority or Other||Mean Difference (Final Values)|-0.63||||0.019||95.0|-1.15|-0.1|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746470|NCT00394901|3209704|Superiority or Other||Mean Difference (Final Values)|-0.86||||0.002||95.0|-1.39|-0.32|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746471|NCT00394901|3209704|Superiority or Other||Mean Difference (Final Values)|-0.31||||0.262||95.0|-0.85|0.23|||ANCOVA|The model included treatment and CLcr stratum as factors, and baseline score as covariate.||Hypothesis testing was conducted using two-sided tests with significance level of 0.05.|
1746472|NCT00394836|3209728|Superiority or Other||percentage of responders|10.0|||||2-Sided|95.0|5.0|19.0|||||||
1746474|NCT00394706|3209743|Superiority||Mean Difference (Final Values)|-0.02|||||2-Sided|95.0|-0.08|0.05|||||Mean HUI for Active ITD minus mean HUI for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.|
1746475|NCT00394706|3209743|Superiority||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.06|0.05|||||Mean HUI for Analyze Later minus mean HUI for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.|
1746476|NCT00394706|3209744|Superiority||Mean Difference (Final Values)|-0.66|||||2-Sided|95.0|-1.61|0.28|||||Mean ALFI-MMSE for Active ITD minus mean ALFI-MMSE for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.|
1746477|NCT00394706|3209744|Superiority||Mean Difference (Final Values)|0.06|||||2-Sided|95.0|-0.71|0.83|||||Mean ALFI-MMSE for Analyze Later minus mean ALFI-MMSE for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.|
1746478|NCT00394706|3209745|Superiority||Mean Difference (Final Values)|0.14|||||2-Sided|95.0|-0.17|0.44|||||Mean MRS for Active ITD minus mean MRS for Sham ITD (i.e. positive values favor the active device).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.|
1746479|NCT00394706|3209745|Superiority||Mean Difference (Final Values)|0.07|||||2-Sided|95.0|-0.2|0.34|||||Mean MRS for Analyze Later minus mean MRS for Analyze Early (i.e. positive values favor Analyze Later).|Linear regression was used to assess associations between post-discharge measures and treatment group comparisons with adjustment for baseline characteristics. Site was adjusted for to accommodate clustering of patients within sites. All regression analyses used robust standard errors to accommodate non-constant variances.|
1746480|NCT00394706|3209746|Superiority or Other||Risk Difference (RD)|0.0||||0.99|2-Sided|95.0|-1.2|1.1|||t-test, 2 sided||Estimate of the rate of survival to hospital discharge in the active ITD arm minus rate in the Sham ITD arm.|Comparison of the rates of survival to hospital discharge in Active ITD and Sham treatment arms.|
1746481|NCT00394706|3209746|Superiority or Other||Risk Difference (RD)|-0.1||||0.92|2-Sided|95.0|-1.2|1.1||Two sided test with an a priori threshold of 0.05 for declaring statistical significance.|GEE||Estimate of the rate of survival to hospital discharge in Analyze Later arm minus rate in Analyze early arm.|Comparison of the rates of survival to hospital discharge in Analyze Early vs. Analyze Later arms using a generalized estimating equations model with an identity link, grouping on cluster.|
1746482|NCT00394706|3209747|Superiority or Other||Risk Difference (RD)|-0.1||||0.71|2-Sided|95.0|-1.1|0.8||To adjust for group sequential monitoring, the point estimate was bias-adjusted (Whitehead 1986) and confidence intervals and P values calculated from the maximum likelihood based ordering of the outcome(Emerson and Fleming, 1990)|t-test, 2 sided||Estimate of the rate of MRS <= 3 in the active ITD arm minus the rate in the Sham ITD arm.|Comparison of the rates of MRS <=3 in Active ITD and Sham treatment arms, adjusted for sequential monitoring.|
1746483|NCT00394706|3209747|Superiority or Other||Risk Difference (RD)|-0.2||||0.59|2-Sided|95.0|-1.1|0.7||Two sided test with an a priori threshold of 0.05 for declaring statistical significance.|Mixed Models Analysis||Estimate of the rate of MRS <= 3 in Analyze Later arm minus rate in Analyze early arm.|Comparison of the rates of MRS <=3 in Analyze Early vs. Analyze Later arms using a linear mixed effect model with an identity link and random effects to account for the cluster randomization.|
1746484|NCT00394654|3209771|Superiority or Other|||||||0.766|||||||Univariate 2-sample t-test||||
1746485|NCT00394654|3209772|Superiority or Other|||||||0.798|||||||Univariate 2-sample t-test||||
1746486|NCT00394654|3209773|Superiority or Other|||||||0.318|||||||Univariate 2-sample t-test||||
1746487|NCT00394654|3209774|Superiority or Other|||||||0.677|||||||Univariate 2-sample t-test||||
1746488|NCT00394654|3209775|Superiority or Other|||||||0.254|||||||Univariate 2-sample t-test||||
1746489|NCT00394654|3209776|Superiority or Other|||||||0.168|||||||Univariate 2-sample t-test||||
1746490|NCT00394355|3209788|Superiority or Other|||||||0.023|||||||ANOVA|||Least square means and Pstd (pooled standard deviations) are obtained from the ANOVA model with treatment effects.|
1746491|NCT00394355|3209788|Superiority or Other||||||<|0.001|||||||ANOVA|||Least square means and Pstd (pooled standard deviations) are obtained from the ANOVA model with treatment effects.|
1746492|NCT00394355|3209789|Superiority or Other|||||||0.526|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."|
1746493|NCT00394355|3209789|Superiority or Other|||||||0.169|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."|
1746494|NCT00394355|3209790|Superiority or Other|||||||0.39|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."|
1746536|NCT00393705|3209869|Superiority or Other|||||||0.4994||||||P-value for 3:00 A.M.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746495|NCT00394355|3209790|Superiority or Other|||||||0.359|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."|
1746496|NCT00394355|3209791|Superiority or Other|||||||0.644|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way ANOVA model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."|
1746497|NCT00394355|3209791|Superiority or Other|||||||0.261|||||||ANOVA|||"Least squares mean percent changes were obtained from the two-way analysis of variance (ANOVA) model with treatment and BMD scan center effects. Results shown use percent change as a response.~Pooled Standard deviation from the ANOVA model with treatment effects."|
1746498|NCT00394329|3209801|Superiority or Other||Cox Proportional Hazard|0.56|Standard Error of the Mean|0.28||0.066|2-Sided|95.0|0.32|0.96||Hochberg adjustment was applied to the p-value to account for each of three active group comparisons to the placebo group. The unadjusted p-value is 0.033.|Regression, Cox||||
1746499|NCT00394277|3209802|Superiority or Other||Odds Ratio (OR)|1.008||||0.951||95.0|0.78|1.304||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)|
1746500|NCT00394277|3209803|Superiority or Other||Odds Ratio (OR)|1.004||||0.973||95.0|0.777|1.299||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)|
1746501|NCT00394277|3209804|Superiority or Other||Odds Ratio (OR)|1.039||||0.775||95.0|0.803|1.344||All secondary comparisons are tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||(PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)|
1746502|NCT00394277|3209805|Superiority or Other||Odds Ratio (OR)|1.075||||0.584||95.0|0.831|1.391||All secondary comparisons were tested at a two-sided significance level of 0.05.|Cochran-Mantel-Haenszel|P-value obtained from CMH test, stratified by country and ribavirin dose strata.||This reflects the primary protocol-specified comparison (standard Pegasys induction dosing arms versus pooled Pegasys induction dosing arms). The study was designed to have at least 86% power for testing the null hypothesis of no difference between these two pooled groups, with assumed response rates of 28%, 32%, 36%, and 43% in the four treatment arms.|
1746503|NCT00394251|3209806|Superiority or Other (legacy)|||||||0.323|||||||Fisher Exact|||Comparison of percentage of participants with at least one taxane-emergent toxicity|
1746504|NCT00394251|3209812|Superiority or Other (legacy)|||||||0.641|||||||Fisher Exact|||Comparison of percentage of participants with at least one taxane-emergent toxicity|
1746505|NCT00394212|3209815|Superiority or Other|||||||0.174||||||P-value from two-sided Fisher’s exact test comparing percents achieved for the two treatments.|Fisher Exact||||
1746506|NCT00394212|3209816|Superiority or Other|||||||0.019||||||P-value from two-sided Fisher’s exact test comparing percents achieved for the two treatments.|Fisher Exact||||
1746507|NCT00394212|3209817|Superiority or Other|||||||0.317||||||P-value from two-sided Fisher's exact test comparing percents achieving 15% EWL at 6 months for the two treatments.|Fisher Exact||||
1746508|NCT00394212|3209818|Superiority or Other|||||||0.066||||||P-value from non-parametric Mann-Whitney-Wilcoxon test comparing treatments.|Wilcoxon (Mann-Whitney)|||Based on a 2-group test of means for unequal variance and unequal sample size (2:1 randomization ratio) with alpha = 0.05 and a power of 80%, the sample size required was 132; 88 subjects in the Transoral Suturing arm and 44 in the Sham Endoscopy arm. The study was prematurely discontinued due to reasons unrelated to safety and effectiveness and therefore was underpowered for evaluation of the primary and secondary hypotheses.|
1746509|NCT00393939|3209833|Superiority or Other||Hazard Ratio (HR)|1.1539||||0.8933|2-Sided|95.0|0.9209|1.4458||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank||||
1746510|NCT00393939|3209835|Superiority or Other||Odds Ratio (OR)|1.44||||0.0172|2-Sided|95.0|1.03|2.02||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Cochran-Mantel-Haenszel|||Investigator's assessment|
1746511|NCT00393939|3209835|Superiority or Other||Odds Ratio (OR)|1.65||||0.0018|2-Sided|95.0|1.17|2.33||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Cochran-Mantel-Haenszel|||Independent radiology assessment|
1746512|NCT00393939|3209836|Superiority or Other||Hazard Ratio (HR)|0.856||||0.0753|2-Sided|95.0|0.6921|1.0589||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||Investigator's assessment|
1746513|NCT00393939|3209836|Superiority or Other||Hazard Ratio (HR)|0.9222||||0.2651|2-Sided|95.0|0.7156|1.1885||1-sided stratified log-rank test adjusted for baseline stratification factors (number of metastatic sites, estrogen receptor status, and disease-free interval from prior adjuvant treatment)|Log Rank|||Independent radiology assessment|
1746514|NCT00393887|3209840|Superiority or Other|||||||0.11|||||||Fisher Exact|||Two-sided Fisher's exact test|
1746515|NCT00393718|3209852|Superiority or Other||Rate ratio|0.2||||||95.0|0.11|0.34||||||The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.|
1746516|NCT00393718|3209852|Superiority or Other||Rate ratio|0.18||||||95.0|0.09|0.36||||||The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.|
1746517|NCT00393718|3209852|Superiority or Other||Rate ratio|0.2||||||95.0|0.12|0.35||||||The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.|
1746518|NCT00393718|3209853|Superiority or Other||Least Squares Mean|-1.71||||||95.0|-2.25|-1.18||||||95% confidence interval for the mean difference (liraglutide – glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746519|NCT00393718|3209854|Superiority or Other||Least Squares Mean|-1.91|||<|0.0001||95.0|-2.34|-1.48||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.|
1746520|NCT00393718|3209855|Superiority or Other||Least Squares Mean|-13.03||||||95.0|-21.46|-4.6||||||95% confidence interval for the mean difference (liraglutide – glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746521|NCT00393718|3209856|Superiority or Other||Least Squares Mean|-19.97|||<|0.0001||95.0|-27.99|-11.94||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.|
1746522|NCT00393718|3209857|Superiority or Other||Least Squares Mean|-17.21||||||95.0|-26.32|-8.09||||||95% confidence interval for the mean difference (liraglutide – glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746523|NCT00393718|3209858|Superiority or Other||Least Squares Mean|-17.63|||<|0.0001||95.0|-25.0|-10.27||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.|
1746524|NCT00393718|3209859|Superiority or Other||Least Squares Mean|-74.51||||||95.0|-105.75|-43.27||||||95% confidence interval for the mean difference (liraglutide – glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746525|NCT00393718|3209860|Superiority or Other||Least Squares Mean|-93.05|||<|0.0001||95.0|-119.61|-66.5||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.|
1746526|NCT00393718|3209861|Superiority or Other||Least Squares Mean|-11.7||||||95.0|-18.6|-4.9||||||95% confidence interval for the mean difference (liraglutide – glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746527|NCT00393718|3209862|Superiority or Other||Least Squares Mean|-12.9|||<|0.0001||95.0|-18.2|-7.5||A significance level of a two-sided 5% was used for statistical hypothesis testing.|ANOVA|||The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.|
1746528|NCT00393718|3209863|Superiority or Other||Least Squares Mean|-0.49||||||95.0|-0.71|-0.27||||||95% confidence interval for the mean difference (liraglutide – glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.|
1746529|NCT00393718|3209864|Non-Inferiority or Equivalence|Non-inferiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.4%. Superiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.0%.|Least Squares Mean|-0.5|||<|0.0001||95.0|-0.7|-0.3||p-value is for the null hypothesis for superiority. A significance level of a one-sided 2.5% was used for statistical hypothesis testing.|ANOVA|||"ANOVA model included HbA1C at baseline as a covariate and treatment group and pre-trial treatment as fixed effects.~Hypothesis for non-inferiority:~H0: μ0.9 - μG ≥ 0.4, H1: μ0.9 - μG < 0.4,~Hypothesis for superiority:~H0: μ0.9 - μG ≥ 0.0, H1: μ0.9 - μG < 0.0, where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively. When non-inferiority was confirmed, superiority was evaluated based on the closed testing procedure."|
1746530|NCT00393705|3209865|Superiority or Other|||||||0.0421||||||P-value for Week 12|ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746531|NCT00393705|3209865|Superiority or Other|||||||0.0056||||||P-value for Week 4|ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746532|NCT00393705|3209866|Superiority or Other|||||||0.0009|||||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746533|NCT00393705|3209867|Superiority or Other|||||||0.8876||||||P-value for Severe Hypoglycemic Episodes/30 Days.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746538|NCT00393705|3209869|Superiority or Other|||||||0.1885||||||P-value for Pre-Dinner.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746539|NCT00393705|3209869|Superiority or Other|||||||0.0077||||||P-value for 2-Hours After Lunch.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746540|NCT00393705|3209869|Superiority or Other|||||||0.1947||||||P-value for Pre-Lunch.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746541|NCT00393705|3209869|Superiority or Other|||||||0.0027||||||P-value for 2-Hours After Breakfast.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746542|NCT00393705|3209869|Superiority or Other|||||||0.0129||||||P-value for Fasting.|ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746543|NCT00393705|3209870|Superiority or Other|||||||0.0002|||||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746544|NCT00393705|3209871|Superiority or Other|||||||0.0077|||||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746545|NCT00393705|3209873|Superiority or Other|||||||0.0471||||||P-value for HbA1c ≤6.5%. Additional statistically significant term from the model below was baseline HbA1c.|Regression, Logistic|Model: Logit(p(response)/1-p(response)) = U + r' X, where u = intercept parameter, X = vector of parameters (treatment, baseline value, lead-in).|||
1746546|NCT00393705|3209873|Superiority or Other|||||||0.0287||||||P-value for HbA1c <7%. Additional statistically significant terms from the model below were baseline HbA1c and treatment by lead-in interaction.|Regression, Logistic|Model: Logit(p(response)/1-p(response)) = U + r' X, where u = intercept parameter, X = vector of parameters (treatment, baseline value, lead-in).|||
1746547|NCT00393705|3209874|Superiority or Other|||||||0.2519|||||||ANCOVA|Model: Value = Treatment + Lead-in + Treatment*Lead-in + Visit + Treatment*Visit + Value at baseline + error.|||
1746548|NCT00393523|3209877|Superiority or Other||Seroprotection Rate (SPR)|97.3||||||95.0|95.0|98.8|||||"Exact binomial confidence interval~Seroprotection Rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL"|The purpose of the secondary analysis is to demonstrate that there is an adequate SPR in subjects who received a primary vaccination series of ENGERIX-B™ and a booster dose of modified process hepatitis B vaccine. An adequate response requires the lower bound of the two-sided 95% confidence interval for the SPR to exceed 90%.|
1746549|NCT00393523|3209878|Superiority or Other||Seroprotection rate (SPR)|91.6||||0.19||95.2|88.0|94.4||"Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be > 90% (P-Value < .024).~Since only one group met the criteria, that group was retested at α=.012."|Hochberg's step up|The primary hypothesis was evaluated using Hochberg’s step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.|
1746550|NCT00393523|3209878|Superiority or Other||Seroprotection rate (SPR)|95.0|||<|0.001||97.6|91.6|97.3||Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be > 90% (P-Value < .024). Since only one group met the criteria, that group was retested at α=.012.|Hochberg's step up|The primary hypothesis was evaluated using Hochberg’s step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.|
1746551|NCT00393523|3209878|Superiority or Other||Seroprotection rate (SPR)|95.0|||<|0.001||95.2|92.1|97.1||"Adequate SPR required the lower bound of the 95.2% CI for the SPR for subjects in both Group 1 and Group 2 to be > 90% (P-Value < .024).~Since only one group met the criteria, that group was retested at α=.012."|Hochberg's step up|The primary hypothesis was evaluated using Hochberg’s step up approach to control multiplicity.|Seroprotection rate (SPR)- defined as the percentage of subjects who demonstrate antibodies to hepatitis B surface antigen ≥10 mIU/mL|The primary purpose of this study was to show that subjects who received a primary series of RECOMBIVAX HB™ in the first year of life were adequately protected by RECOMBIVAX HB™ by measuring the immune response to a single booster dose of either a modified process vaccine or ENGERIX-B™.|
1746552|NCT00393484|3209884|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Viral rebound at 96 weeks|
1746553|NCT00393484|3209885|Superiority or Other||Difference|52.23|||<|0.0001|2-Sided|90.0|39.54|64.93|||Chi-squared||At 240 Weeks||
1746554|NCT00393484|3209885|Superiority or Other||Difference|44.64|||<|0.0001|2-Sided|90.0|31.17|58.11|||Chi-squared||At 192 Weeks||
1746555|NCT00393484|3209885|Superiority or Other||Difference|33.48|||<|0.0003|2-Sided|90.0|19.31|47.65|||Chi-squared||At 144 Weeks||
1746556|NCT00393484|3209885|Superiority or Other||Mean Difference (Final Values)|46.21|||<|0.0001|2-Sided|90.0|34.8|57.61|||Chi-squared||At 96 Weeks||
1746557|NCT00393484|3209885|Superiority or Other||Difference|33.71|||<|0.0001|2-Sided|90.0|22.52|44.89|||Chi-squared||At 48 Weeks||
1746558|NCT00393484|3209891|Superiority or Other||Difference|35.94|||<|0.0001|2-Sided|90.0|23.35|48.52|||Chi-squared||At 96 Weeks||
1746559|NCT00393484|3209891|Superiority or Other||Difference|26.34|||<|0.0014|2-Sided|90.0|13.65|39.03|||Chi-squared||At 48 Weeks||
1746560|NCT00393484|3209891|Superiority or Other||Difference|18.97|||<|0.0278|2-Sided|90.0|5.22|32.73|||Chi-squared||At 24 Weeks||
1746561|NCT00393484|3209893|Superiority or Other||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 240.|
1746562|NCT00393484|3209893|Superiority or Other||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 192.|
1746563|NCT00393484|3209893|Superiority or Other||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 144.|
1746564|NCT00393484|3209893|Superiority or Other||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at 96 Weeks.|
1746565|NCT00393484|3209893|Superiority or Other||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariants of treatment and Baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from Baseline were based on patients with measurements at both Baseline and at Week 48.|
1746566|NCT00393484|3209893|Superiority or Other||||||<|0.0001||||||Treatment comparisons were based on 2-sided t-test for treatment difference (entecavir: lamivudine) estimated from the linear regression model with covariates of treatment and baseline hepatitis B DNA by PCR.|unpaired t-test|||Changes from baseline were based on patients with measurements at both Baseline and Week 24.|
1746567|NCT00393484|3209894|Superiority or Other||Difference|24.33||||0.0006|2-Sided|90.0|13.71|34.95|||Chi-squared|||HBV DNA <10^5 copies/mL at 96 Weeks|
1746568|NCT00393484|3209894|Superiority or Other||Difference|29.02|||<|0.0001|2-Sided|90.0|18.07|39.97|||Chi-squared|||HBV DNA <10^4 copies/mL at 96 Weeks|
1746569|NCT00393484|3209894|Superiority or Other||Difference|35.27|||<|0.0001|2-Sided|90.0|24.02|46.51|||Chi-squared|||HBV DNA <10^3 copies/mL at 96 Weeks|
1746570|NCT00393484|3209894|Superiority or Other||Difference|16.96|||<|0.0029|2-Sided|90.0|8.43|25.5|||Chi-squared|||HBV DNA <10^5 at 48 Weeks|
1746571|NCT00393484|3209894|Superiority or Other||Difference|20.09|||<|0.0009|2-Sided|90.0|11.1|29.07|||Chi-squared|||HBV DNA <10^4 copies/mL at 48 Weeks|
1746572|NCT00393484|3209894|Superiority or Other||Difference|26.12|||<|0.0002|2-Sided|90.0|15.87|36.36|||Chi-squared|||HBV DNA <10^3 copies/mL at 48 Weeks|
1746573|NCT00393484|3209894|Superiority or Other||Mean Difference (Final Values)|4.24|||<|0.4467|2-Sided|90.0|-2.62|11.1|||Chi-squared|||HBV DNA <10^5 at 24 Weeks|
1746574|NCT00393484|3209894|Superiority or Other||Difference|13.62|||<|0.0167|2-Sided|90.0|4.85|22.38||Treatment comparisons were assessed using the same method as the primary endpoint.|Chi-squared|||HBV DNA <10^4 copies/mL at 24 Weeks|
1746575|NCT00393484|3209894|Superiority or Other||Difference|24.55|||<|0.0003|2-Sided|90.0|14.45|34.66||Treatment comparisons were assessed using the same method used in the primary endpoint.|Chi-squared|||HBV DNA <10^3 copies/mL at 24 Weeks|
1746576|NCT00393484|3209895|Non-Inferiority or Equivalence|The difference in proportion along with its standard error and 90% confidence interval was computed. If the lower limit of the confidence interval (CI) was great than -10%, noninferiority was established. Provided that noninferiority was established, a test for superiority was planned to check that the lower limit of the 90% CI was greater than zero.|Difference in proportion|25.67||||0.0006|2-Sided|90.0|14.48|36.86||There was no adjustment for the prior test of noninferiority because the test for superiority could succeed only if noninferiority was first established.|Chi-squared|||A sample size of 60 per group provides 80% power for testing superiority of entecavir compared to lamivudine, assuming a response rate of 62% for lamivudine and 83% for entecavir.|
1746577|NCT00393367|3209908|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|0.36||0.78|2-Sided|95.0|-0.6|0.8|||t-test, 2 sided||||
1746578|NCT00393367|3209910|Superiority or Other||Risk Difference (RD)|-0.14||||0.22|2-Sided|95.0|-0.37|0.08|||Chi-squared||||
1746579|NCT00393367|3209911|Superiority or Other||Risk Difference (RD)|0.22||||0.08|2-Sided|95.0|-0.02|0.47|||Chi-squared||||
1746580|NCT00393367|3209912|Superiority or Other||Risk Difference (RD)|-0.03||||0.69||95.0|-0.2|0.14|||Chi-squared||||
1746581|NCT00393367|3209913|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.49|||2-Sided|95.0|-1.0|1.0|||||||
1746582|NCT00393367|3209914|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|1.6|||2-Sided|95.0|-3.0|3.0|||||||
1746583|NCT00393367|3209915|Superiority or Other||Mean Difference (Net)|-1.0|Standard Error of the Mean|3.0|||2-Sided|95.0|-7.0|6.0|||||||
1746584|NCT00393367|3209916|Superiority or Other||Risk Difference (RD)|0.0||||0.97|2-Sided|95.0|-0.14|0.14|||Chi-squared||||
1746585|NCT00393367|3209917|Superiority or Other|||||||0.44||||||The difference in median improvement between treatment groups was expected to be greater than 2.|Wilcoxon (Mann-Whitney)||||
1746586|NCT00392925|3209968|Superiority or Other|||||||0.0004|||||||ANCOVA|||Based on an Analysis of Covariance model including factors for treatment group, sex, enrollment body mass index (BMI) category, lead-in body weight loss category, and baseline (Day 1) weight as a covariate. The p-value is for testing the null hypothesis of no difference between treatments. Analysis performed two-sided at a 5% significance level to compare treatment groups.|
1746587|NCT00392678|3210001|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis||||
1746588|NCT00392379|3210011|Superiority or Other||Odds Ratio (OR)|3.0|Standard Deviation|43.0|<|0.05|2-Sided|95.0||||No adjustment for multiple comparisons.|Regression, Logistic|||Based upon previous research, we hypothesized that the end-of-treatment abstinence rate for subjects receiving placebo would be 35% and the abstinence rate for subjects receiving the 4-mg nicotine lozenge would be 53%. A resulting power calculation indicated that 270 subjects (135 per group) were required in order to have 85% power to detect a significant difference (two-sided, α = 0.05 level test).|
1746615|NCT00391274|3210130|Superiority or Other||Hazard Ratio (HR)|1.02||||0.9256|2-Sided|95.0|0.74|1.4||P-value for Overall Survival (up to 30 months)|Regression, Cox||||
1746616|NCT00391274|3210130|Superiority or Other||Hazard Ratio (HR)|1.14||||0.4921||95.0|0.78|1.68||P-value for Overall Survival (up to 24 months)|Regression, Cox|Treatment was the only covariate.|||
1746589|NCT00392288|3210014|Superiority or Other|||||||0.9146||||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age [yrs] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. As statistical test a t-test was used to compare the corresponding least-square means of Ciclesonide 40 versus Placebo.|
1746590|NCT00392288|3210014|Superiority or Other|||||||0.0703||||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age [yrs] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. A t-test was used to compare the least-square means of Ciclesonide 80 versus Placebo.|
1746591|NCT00392288|3210014|Superiority or Other|||||||0.2696||||||Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.|ANCOVA|ANCOVA model: Change in FEV1 = baseline FEV1 + age [yrs] + treatment + pooled center + previous corticosteroid therapy + holding chamber||This is an analysis of the change from baseline to week 12 or last visit. In this pairwise comparison Ciclesonide was compared with Placebo by testing the average effect of Ciclesonide 40 and Ciclesonide 80 versus Placebo. As statistical test a t-test was used to compare the corresponding least-square means of both treatment groups.|
1746592|NCT00392236|3210015|Superiority or Other|||||||0.083|||||||ANOVA||||
1746593|NCT00392223|3210017|Non-Inferiority or Equivalence|Analysis performed to assess non-inferiority by calculation & examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.|Mean Difference (Final Values)|-0.87||||||95.0|-2.58|0.84|||||ANCOVA adjusted for baseline, center and treatment.||
1746594|NCT00392223|3210021|Non-Inferiority or Equivalence|Analysis performed to assess non-inferiority by calculation & examination of 95% CI. Analysis conducted via analysis of covariance (ANCOVA) including corresponding baseline value and centre as covariates. Non-inferiority margin was chosen as largest clinically acceptable difference. This was set as difference of 3 in GAGS global score. Azithromycin declared non-inferior to minocycline when two-sided 95% confidence interval for difference lied entirely to right of non-inferiority margin.|Mean Difference (Final Values)|-0.47||||||95.0|-2.48|1.54|||||Comparison between treatment groups was performed using an analysis of covariance (ANCOVA) method, with treatment, center, and baseline value GAGS global score included as covariates.||
1746595|NCT00392054|3210028|Superiority or Other (legacy)||Hazard Ratio (HR)|0.86||||0.66|2-Sided|95.0|0.42|1.72|||Regression, Cox||||
1746596|NCT00392054|3210029|Superiority or Other (legacy)||Hazard Ratio (HR)|0.33|||<|0.0001|2-Sided|95.0|0.28|0.4|||Regression, Cox||||
1746597|NCT00392054|3210030|Superiority or Other (legacy)||Hazard Ratio (HR)|0.52||||0.017|2-Sided|95.0|0.3|0.89|||Regression, Cox||||
1746598|NCT00392054|3210031|Superiority or Other (legacy)||Hazard Ratio (HR)|0.56||||0.03|2-Sided|95.0|0.33|0.95|||Regression, Cox||||
1746599|NCT00392054|3210033|Superiority or Other (legacy)||Hazard Ratio (HR)|0.56||||0.0016|2-Sided|95.0|0.35|0.9||Cox regression analysis, stratified by clinical site, was performed and presented as hazard ratios with 95% confidence intervals and a two-sided p-value testing of less than or equal to 0.05 (two-sided) for the Wald test.|Regression, Cox|||Event rates were plotted over time using Kaplan-Meier methodology. Only events occurring after the 90-day treatment period were included in the final analysis. Treatment groups were analyzed on an intention-to-treat basis.|
1746600|NCT00391768|3210095|Superiority or Other|||||||0.96|||||||Spearman Correlation||||
1746601|NCT00391768|3210095|Superiority or Other|||||||0.47|||||||Spearman Correlation||||
1746602|NCT00391768|3210095|Superiority or Other|||||||0.77|||||||Spearman Correlation||||
1746603|NCT00391768|3210095|Superiority or Other|||||||0.27|||||||Spearman Correlation||||
1746604|NCT00391768|3210095|Superiority or Other|||||||0.6|||||||Spearman Correlation||||
1746605|NCT00391768|3210095|Superiority or Other|||||||0.07|||||||Spearman Correlation||||
1746606|NCT00391716|3210102|Superiority or Other||||||<|0.003||||||Cumulative means over 12 weeks|ANOVA||||
1746607|NCT00391716|3210103|Superiority or Other||||||<|0.001||||||Cumulative means over 12 weeks|ANOVA||||
1746608|NCT00391716|3210104|Superiority or Other||||||<|0.001||||||Cumulative means over 12 weeks|ANOVA||||
1746609|NCT00391716|3210105|Superiority or Other||||||<|0.02||||||linear dose effects for rates of abstinence were assessed using the extended Mantel-Haenszel chi-square test for linear association.|Mantel Haenszel|The numerator is the number of subjects completely abstinent and the denominator is the number of subjects randomized, within each treatment group.||The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= heavy drinking, 1=no heavy drinking), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.|
1746610|NCT00391716|3210105|Superiority or Other||||||<|0.04||||||The numerator is the number of subjects completely abstinent and the denominator is the number of subjects randomized, within each treatment group.|Mantel Haenszel|Extended Mantel-Haenszel Chi-square test for linear-by-linear association.||The extended Mantel-Haenszel Chi-square test for linear trend assesses the relationship between ROW and COLUMN of a single contingency table, where both row (dose: 0mg, 900mg, 1800mg) and column (response (0= non-abstinent, 1=abstinent), and at least 1 variable has more than 2 levels. It specifically tests linear dose-response without need for multiple comparisons.|
1746611|NCT00391599|3210111|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1746612|NCT00391599|3210113|Superiority or Other|||||||0.15|||||||Chi-squared||||
1746613|NCT00391443|3210118|Superiority or Other||Relative risk reduction|0.17||||0.2542|2-Sided|95.0|-0.13|0.39|||Fisher Exact||||
1746614|NCT00391443|3210119|Superiority or Other||Hazard Ratio (HR)|0.85||||0.211|2-Sided|95.0|0.658|1.097|||Log Rank||||
1746619|NCT00391274|3210134|Superiority or Other||Odds Ratio (OR)|2.5||||0.1326||95.0|0.76|8.25||Logistic regression of best overall tumor response (complete response + partial response).|Regression, Logistic|Treatment was the only covariate.|||
1746620|NCT00391222|3210136|Superiority or Other|||||||0.001|||||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline MADRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.|
1746621|NCT00391222|3210136|Superiority or Other|||||||0.48|||||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline MADRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.|
1746622|NCT00391222|3210137|Superiority or Other||||||<|0.001|||||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline YMRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.|
1746623|NCT00391222|3210137|Superiority or Other||||||<|0.001|||||||ANCOVA|||An ANCOVA model was applied to the change from baseline of Period III at each time point in Period III, with treatment, patient type at screening, and geographic region as factors and baseline YMRS total score as covariate. The comparison between active treatment and placebo was performed based on the LS means obtained from the ANCOVA model. The difference in LS means between treatment arms was estimated, as was the 95% confidence interval for the difference.|
1746624|NCT00391222|3210138|Superiority or Other||||||<|0.0001|||||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.|
1746625|NCT00391222|3210138|Superiority or Other||||||<|0.2882|||||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.|
1746626|NCT00391222|3210139|Superiority or Other|||||||0.011|||||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.|
1746627|NCT00391222|3210139|Superiority or Other|||||||0.655|||||||Log Rank|||The time-to-event data were evaluated by means of the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.|
1746628|NCT00391222|3210140|Superiority or Other||||||<|0.0001|||||||Log Rank|||The time-to-event data were evaluated by the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.|
1746629|NCT00391222|3210140|Superiority or Other||||||<|0.005|||||||Log Rank|||The time-to-event data were evaluated by the same survival analysis method as used for the primary outcome. The recurrence rates (Kaplan-Meier estimated) were calculated for each treatment arm using the same methods as for the primary outcome.|
1746630|NCT00391222|3210141|Superiority or Other|||||||0.057||||||As defined in the protocol, the olanzapine arm was not included in the primary outcome comparison. Data on the olanzapine arm are presented in outcome measure 7.|Log Rank|||Comparison between risperidone LAI and placebo was performed using a log-rank test controlling for patient type at screening (acute or non-acute) and for geographic region. As recurrence rates at 9 months were assumed to be 45% for risperidone LAI and 68% for placebo, the study would have approximately 90% power to detect a clinically meaningful difference of 23% in recurrence rates of a mood episode if in Period III 100 patients were randomized to each of the 2 relevant treatment arms.|
1746631|NCT00391092|3210144|Superiority or Other||Hazard Ratio (HR)|0.94||||0.5392|2-Sided|95.0|0.76|1.15|||Log Rank||||
1746632|NCT00391092|3210145|Superiority or Other||Hazard Ratio (HR)|0.74|||||2-Sided|95.0|0.56|0.98|||||||
1746633|NCT00391092|3210146|Superiority or Other||Difference in Response rates|4.43||||0.3492|2-Sided|95.0|-5.2|14.0|||Chi-squared||95% CI for the difference in response rates using Hauck-Anderson method.||
1746634|NCT00391092|3210147|Superiority or Other||Hazard Ratio (HR)|1.01||||0.9543|2-Sided|95.0|0.74|1.38|||Log Rank||||
1746635|NCT00391092|3210148|Superiority or Other||Hazard Ratio (HR)|0.82||||0.0775|2-Sided|95.0|0.65|1.02|||Log Rank (unstratified)||||
1746636|NCT00391079|3210149|Superiority or Other||estimated treatment difference|0.05||||0.833|2-Sided|95.0|-0.39|0.48|||ANCOVA||A negative difference in estimated treatment difference indicates an improvement in sleep quality in favour of Sativex.||
1746637|NCT00391079|3210150|Superiority or Other||Odds Ratio, log|1.47||||0.0552|2-Sided|95.0|0.991|2.179|||Regression, Logistic||An odds ratio of greater than 1 indicates and improvement in favour of Sativex.||
1746638|NCT00391079|3210151|Superiority or Other||Estimated treatment difference|-0.12||||0.5643|2-Sided|95.0|-0.53|0.29|||ANCOVA||A negative difference in estimated means indicates an improvement in pain in favour of Sativex.||
1746639|NCT00391079|3210152|Superiority or Other||Estimated treatment difference|-0.24||||0.1567|2-Sided|95.0|-0.57|0.09|||ANCOVA||A negative difference in estimated treatment difference indicates a reduction in breakthrough analgesic medication in favour of Sativex.|The change in average number of tablets taken daily from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.|
1746695|NCT00389207|3210437|Non-Inferiority or Equivalence|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.009||||0.855||95.0|-0.084|0.101||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.|||
1746640|NCT00391079|3210153|Superiority or Other||Estimated treatment effect|-1.83||||0.3103|2-Sided|95.0|-5.39|1.72|||ANOVA||A negative difference in estimated treatment effect indicates an improvement in pain in favour of Sativex.|The change in NPS score from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.|
1746641|NCT00391079|3210154|Superiority or Other||Odds Ratio (OR)|1.309||||0.2338|2-Sided|95.0|0.84|2.038|||Regression, Logistic|||The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each Sativex and placebo.|
1746642|NCT00391079|3210155|Superiority or Other||Estimated treatment effect|-0.17||||0.468|2-Sided|95.0|-0.62|0.29|||ANCOVA|||The change in pain NRS score from baseline to the end of study was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and centre group and treatment as factors.|
1746643|NCT00390806|3210252|Superiority or Other||Hazard Ratio (HR)|0.88||||0.1862|2-Sided|95.0|0.73|1.07||p-value from a stratified log-rank test is adjusted for Recursive Partitioning Analysis (RPA) class and the number of brain lesions at Screening.|Log Rank||The hazard ratio is estimated using a Pike estimator. The hazard ratio from a stratified log-rank test is adjusted for RPA class and the number of brain lesions at Screening.||
1746644|NCT00390780|3210254|Superiority or Other|||||||0.9564|||||||Wilcoxon (Mann-Whitney)|||Analysis for Miconazole minimum inhibitory concentration (MIC) between treatment groups|
1746645|NCT00390780|3210254|Superiority or Other|||||||0.186|||||||Wilcoxon (Mann-Whitney)|||Analysis for Clotrimazole minimum inhibitory concentration (MIC) between treatment groups|
1746646|NCT00390780|3210259|Non-Inferiority or Equivalence|Non-inferiority statistical analysis for PP population.|difference in proportion relapsed|0.15||||0.9738|1-Sided|95.0|-0.15|||Significance level is <0.025.|Chi-squared||||
1746647|NCT00390780|3210259|Non-Inferiority or Equivalence|Non-inferiority statistical analysis for ITT population.|difference in proportion relapsed|0.15||||0.833|1-Sided|95.0|-0.15|||Significance level is <0.025.|Chi-squared||||
1746648|NCT00390780|3210260|Non-Inferiority or Equivalence|Non-inferiority statistical analysis for PP population|difference in proportion mycologic cure|0.15||||0.4439|1-Sided|95.0|-0.15|||Significance level was <0.025.|Chi-squared||||
1746649|NCT00390780|3210260|Non-Inferiority or Equivalence|Non-inferiority statistical analysis for ITT population.|difference in proportion mycologic cure|0.15||||0.5816|1-Sided|95.0|-0.15|||Significance level was <0.025.|Chi-squared||||
1746650|NCT00390780|3210261|Non-Inferiority or Equivalence|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of partial response|0.15||||0.9033|1-Sided|95.0|-0.15|||Significance level was <0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15"|
1746651|NCT00390780|3210261|Non-Inferiority or Equivalence|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of partial response|0.15||||0.882|1-Sided|95.0|-0.15|||Significance level was <0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: partial response rate for miconazole Lauriad minus partial response rate for clotrimazole troches is less than or equal to -0.15 H1: partial response rate for miconazole Lauriad minus partial response rate for Mycelex troches is greater than -0.15"|
1746652|NCT00390780|3210262|Non-Inferiority or Equivalence|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.7969|1-Sided|95.0|-0.15|||Significance level was <0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|
1746653|NCT00390780|3210262|Non-Inferiority or Equivalence|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.8787|1-Sided|95.0|-0.15|||Significance level was <0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|
1746654|NCT00390780|3210263|Non-Inferiority or Equivalence|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|Compare proportion of clinical success|0.15||||0.1115|1-Sided|95.0|-0.15|||Significance level was <0.025.|Cochran-Mantel-Haenszel|||"Analysis for PP population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|
1746655|NCT00390780|3210263|Non-Inferiority or Equivalence|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Type I error: 2.5% Type II error: 5%"|compare proportion of clinical success|0.15||||0.0974|1-Sided|95.0|-0.15|||Significance level was <0.025.|Cochran-Mantel-Haenszel|||"Analysis for ITT population:~H0: clinical success rate for miconazole Lauriad minus clinical success rate for clotrimazole troches is less than or equal to -0.15 H1: clinical success rate for miconazole Lauriad minus clinical success rate for Mycelex troches is greater than -0.15"|
1746656|NCT00390780|3210264|Non-Inferiority or Equivalence|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%"|comparison of proportion clinical cure|0.15|||>|0.025|1-Sided|95.0|-0.15|||Significance level was <0.025.|one-sided noninferiority test|||"Analysis for ITT and PP populations:~H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15"|
1746696|NCT00389207|3210437|Non-Inferiority or Equivalence|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.025||||0.584||95.0|-0.065|0.115||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.|||
1746657|NCT00390780|3210265|Non-Inferiority or Equivalence|"Non inferiority assumptions:~Type of test: one-sided Inferiority margin: -15% Expected cure rate: 70% Type I error: 2.5% Type II error: 5%"|comparison of proportion clinical cure|0.15|||>|0.025|1-Sided|95.0|-0.15|||Significance level was <0.025|one-sided test|||"Analyses for ITT and PP populations:~H0: clinical cure rate for miconazole Lauriad minus clinical cure rate for clotrimazole troches is less than or equal to -0.15 H1: clinical cure rate for miconazole Lauriad minus clinical cure rate for Mycelex troches is greater than -0.15"|
1746658|NCT00390455|3210300|Non-Inferiority or Equivalence (legacy)|The null hypothesis then is that the hazard ratio of the two treatment arms is 1.0; the alternative hypothesis is that the hazard ratio of the control to the experimental regimen is 1.5 (0.67). The test of these hypotheses is one-sided (alpha = 0.025), and interim analyses will be used to stop for futility and superiority. Under these assumptions, there is at least 90% power to detect the stated difference in median PFS between the two treatment arms.|Hazard Ratio (HR)|1.04||||0.37|2-Sided|95.0|0.82|1.33||Tests were stratified by prior tamoxifen therapy (yes/no) and bone disease only (yes/no).|Log Rank||||
1746659|NCT00390299|3210336|Superiority||Hazard Ratio (HR)|1.66||||0.28|2-Sided|95.0|0.67|4.11|||Log Rank||||
1746660|NCT00390299|3210340|Other||Maximum Tolerated Dose (x 10^7 TCID50)|1.0|||||2-Sided||||||||||
1746661|NCT00390299|3210340|Other||Maximum Tolerated Dose (x 10^7 TCID50)|1.0|||||2-Sided||||||||||
1746662|NCT00390221|3210346|Superiority or Other||Relative Mean Change|-4.27||||0.0008|2-Sided|95.0|-6.76|-1.78|||Analysis of Variance|Analysis of variance for difference between treatment groups, controlling for baseline score.||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.|
1746663|NCT00390221|3210346|Superiority or Other||Relative Mean Change|-1.93||||0.1284|2-Sided|95.0|-4.42|0.56||Analysis of variance for difference between treatment groups, controlling for baseline score.|Analysis of Variance|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.|
1746664|NCT00390221|3210347|Superiority or Other||Hazard Ratio (HR)|0.45|||<|0.0001|2-Sided|95.0|0.3|0.67||Covariates included were number of relapses in the 1 year prior to study entry (p=0.001), baseline Expanded Disability Status Scale (<=2.5 versus >2.5, p=0.449), and age (<=35 versus >35, p=0.026).|Cox Proportional Hazard|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.|
1746665|NCT00390221|3210347|Superiority or Other||Hazard Ratio|0.49|||<|0.0003|2-Sided|95.0|0.33|0.72||Covariates included were number of relapses in the 1 year prior to study entry (p=0.001), baseline Expanded Disability Status Scale (<=2.5 versus >2.5, p=0.449), and age (<=35 versus >35, p=0.026).|Cox Proportional Hazard|||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.|
1746666|NCT00390221|3210348|Superiority or Other||Percent Reduction|70.23|||<|0.0001|2-Sided|95.0|59.94|77.88|||Negative Binomial Regression|adjusted for baseline number of T2 lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.|
1746667|NCT00390221|3210348|Superiority or Other||Percent Reduction|78.73|||<|0.0001|2-Sided|95.0|71.33|84.22|||Negative Binomial Regression|adjusted for baseline number of T2 lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.|
1746668|NCT00390221|3210349|Superiority or Other||Percent Reduction|69.47|||<|0.0001|2-Sided|95.0|52.4|80.41|||Negative Binomial Regression|adjusted for the baseline number of Gd-enhancing lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.|
1746669|NCT00390221|3210349|Superiority or Other||Percent Reduction|78.44|||<|0.0001|2-Sided|95.0|65.97|86.35|||Negative Binomial Regression|adjusted for the baseline number of Gd-enhancing lesions||For each of the secondary endpoints, a sequential closed testing procedure was used, with the first comparison (the DAC HYP 300 mg group versus placebo) and the second comparison (the DAC HYP 150 mg group versus placebo). Secondary endpoints were rank prioritized, in the order presented. If statistical significance was not achieved for an endpoint, all endpoints(s) of a lower rank were not considered statistically significant.|
1746670|NCT00390221|3210350|Superiority or Other||Rate Ratio|0.503||||0.0002|2-Sided|95.0|0.352|0.721||adjusted for the number of relapses in the 1 year prior to study entry, baseline Expanded Disability Status Scale (<=2.5 vs > 2.5), and age (<=35 vs >35)|Negative Binomial Regression||||
1746671|NCT00390221|3210350|Superiority or Other||Rate Ratio|0.461|||<|0.0001|2-Sided|95.0|0.318|0.668||adjusted for the number of relapses in the 1 year prior to study entry, baseline Expanded Disability Status Scale (<=2.5 vs > 2.5), and age (<=35 vs >35)|Negative Binomial Regression||||
1746672|NCT00389597|3210381|Non-Inferiority or Equivalence|The 95% one-sided confidence bound for testing non-inferiority using two proportioned test with a 10% non-inferiority margin.|||||<|0.0001|||||||Farrington-Manning|||"2 Level: Ho: pm-pc <=-0.1 (inferiority) Alternative hypothesis: Ha: pm – pc > -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.~2 Level: Ho: pm-pc <= 0 (not superior) Alternative hypothesis: Ha: pm-pc >0 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group."|
1746673|NCT00389597|3210381|Non-Inferiority or Equivalence|The 95% one-sided confidence bound for testing non-inferiority using two proportion test with 10% non-inferiority margin.|||||<|0.0021|||||||Farrington Manning|||1 Level: Ho: pm-pc <=-0.1 (inferiority) Alternative hypothesis: Ha: pm – pc > -0.1 Where pm = the proportion of success in the Mobi-C group and the Pc = the proportion of success in the ACDF group.|
1746674|NCT00389519|3210387|Superiority or Other|||||||0.006||||||two-sided, unadjusted|ANCOVA|test from contrast statement from full model|||
1746675|NCT00389519|3210388|Superiority or Other|||||||0.044||||||two-sided test|ANCOVA|test from contrast statement from full model||"Planned interim efficacy analysis: 80 placebo and 80 high-dose ramipril subjects provided 93% power, alpha=0.032, to detect 5 mmHg difference in primary outcome. SD of 8.5 mmHg assumed. Alpha of 0.032 required for the planned interim efficacy analysis.~If study continued: 450 total subjects would provide 90% power, alpha=0.027, to detect 3 mmHg difference between placebo and combined ramipril dose groups. Alpha of 0.027 required for the final analysis."|
1746676|NCT00389324|3210403|Non-Inferiority or Equivalence|The administration effect between SC and IV was assessed by exponentiation of the difference in least squares means between study phases (Test minus Reference) and the corresponding 90% confidence interval (CI) for the geometric LSM ratio between study phases (Test/Reference) for AUC. The Test (SC) was to be considered non-inferior to Reference (IV) if the lower bound of 90% CIs for the geometric LSM ratios of AUC between the Test and Reference was above 0.80 (80%).|Geometric Least Square Mean Ratio|0.888||||||90.0|0.861|0.917|||||An adjusted steady-state area under the concentration vs. time curve following SC administration based on IV dosing schedule was calculated as AUC0-τ,SC multiplied by 3 or 4 for subjects on every-3-week or every-4-week IV dosing schedule.|The IV phase was considered as the Reference study phase and the SC phase as the Test study phase. The ANOVA included calculation of least-squares means (LSM), differences between adjusted means and the standard error associated with these differences.|
1746677|NCT00389207|3210414|Superiority or Other||Hazard Ratio (HR)|0.731||||0.0444||95.0|0.539|0.992|||Regression, Cox||||
1746678|NCT00389207|3210415|Superiority or Other||Hazard Ratio (HR)|0.762||||0.1329||95.0|0.535|1.086|||Regression, Cox||||
1746679|NCT00389207|3210416|Superiority or Other||Hazard Ratio (HR)|0.63|||<|0.0001||95.0|0.519|0.764|||Regression, Cox|||Cox regression on responders only (N=289 in Nevirapine QD+BID and N=175 in Atazanvir/ritonavir)|
1746680|NCT00389207|3210416|Superiority or Other||Hazard Ratio (HR)|0.692|||<|0.0002||95.0|0.57|0.839|||Regression, Cox||||
1746681|NCT00389207|3210417|Non-Inferiority or Equivalence|H0: Difference in proportions = 0|Difference in proportions|0.016||||0.5659|2-Sided|95.0|-0.039|0.071|||Cochran Chi-Squared|||week 144|
1746682|NCT00389207|3210417|Non-Inferiority or Equivalence|H0: Difference in proportions = 0|Difference in proportions|0.015||||0.5438|2-Sided|95.0|-0.034|0.064|||Cochran Chi-Squared|||week 96|
1746683|NCT00389207|3210417|Non-Inferiority or Equivalence|H0: Difference in proportions = 0|Difference in proportions|-0.023||||0.4585|2-Sided|95.0|-0.084|0.038|||Cochran Chi-Squared|||week 48|
1746684|NCT00389207|3210417|Non-Inferiority or Equivalence|H0: Difference in proportions = 0|Difference in proportions|0.058||||0.0691|2-Sided|95.0|-0.005|0.121|||Cochran Chi-Squared|||week 144|
1746685|NCT00389207|3210417|Non-Inferiority or Equivalence|H0: Difference in proportions = 0|Difference in proportions|0.064||||0.0331|2-Sided|95.0|0.005|0.123|||Cochran Chi-Squared|||week 96|
1746686|NCT00389207|3210417|Non-Inferiority or Equivalence|H0: Difference in proportions = 0|Difference in proportions|0.001||||0.9784|2-Sided|95.0|-0.065|0.066|||Cochran Chi-Squared|||week 48|
1746687|NCT00389207|3210420|Non-Inferiority or Equivalence|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.139||||0.0033||95.0|-0.231|-0.046||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.|||
1746688|NCT00389207|3210420|Non-Inferiority or Equivalence|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.096||||0.0365||95.0|-0.186|-0.006||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.|||
1746689|NCT00389207|3210420|Non-Inferiority or Equivalence|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.117||||0.0031||95.0|-0.194|-0.04||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients.|||
1746690|NCT00389207|3210421|Non-Inferiority or Equivalence|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.122||||0.0073||95.0|-0.212|-0.033||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=187 NVP QD patients and N=193 ATZ/r patients.|||
1746691|NCT00389207|3210421|Non-Inferiority or Equivalence|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.072||||0.1033||95.0|-0.158|0.015||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=186 NVP QD patients and N=193 ATZ/r patients.|||
1746692|NCT00389207|3210421|Non-Inferiority or Equivalence|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.097||||0.0109||95.0|-0.171|-0.022||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD+BID patients and N=193 ATZ/r patients|||
1746693|NCT00389207|3210425|Superiority or Other||Hazard Ratio (HR)|0.461||||0.0403||95.0|0.22|0.966|||Regression, Cox||||
1746694|NCT00389207|3210436|Non-Inferiority or Equivalence|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|-0.038||||0.321||95.0|-0.112|0.037||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Analysis controlling for screening viral load and CD4+ count categories. N=373 NVP QD patients and N=193 ATZ/r patients.|||
1746697|NCT00389207|3210437|Non-Inferiority or Equivalence|Non-inferiority margin 12% (or 0.12 as proportion)|Risk Difference (RD)|0.016||||0.684||95.0|-0.062|0.095||Test for superiority following confirmation of non-inferiority|Cochran-Mantel-Haenszel|Controlling for screening VL and CD4+ categories (only 373 NVP patients due to empty cells)|||
1746698|NCT00388674|3210471|Superiority or Other||Hazard Ratio (HR)|0.91|||||2-Sided|95.0|0.608|1.365|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience||
1746699|NCT00388674|3210472|Superiority or Other||Hazard Ratio (HR)|0.87|||||2-Sided|95.0|0.727|1.032|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience||
1746700|NCT00388674|3210473|Superiority or Other||Hazard Ratio (HR)|1.1|||||2-Sided|95.0|0.817|1.478|||||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience||
1746701|NCT00388674|3210474|Superiority or Other||Hazard Ratio (HR)|0.89||||0.1182|2-Sided|95.03|0.769|1.03|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience||
1746702|NCT00388674|3210475|Superiority or Other||Hazard Ratio (HR)|0.85||||0.0676|2-Sided|95.03|0.713|1.012|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience||
1746703|NCT00388674|3210476|Superiority or Other||Hazard Ratio (HR)|0.93||||0.3553|2-Sided|95.03|0.8|1.084|||Cox proportional hazards model||Hazard Ratio of ETV : Non-ETV Analyses are stratified by geographic region and prior HBV nucleoside/tide experience||
1746704|NCT00388453|3210493|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1746705|NCT00388297|3210503|Superiority or Other|||||||0.39|||||||Wilcoxon (Mann-Whitney)||||
1746706|NCT00388297|3210503|Superiority or Other|||||||0.43|||||||Wilcoxon (Mann-Whitney)||||
1746707|NCT00388297|3210504|Superiority or Other|||||||0.85|||||||Chi-squared||||
1746708|NCT00388297|3210504|Superiority or Other|||||||0.99|||||||Chi-squared||||
1746709|NCT00388297|3210505|Superiority or Other|||||||0.49|||||||Fisher Exact||||
1746710|NCT00388297|3210505|Superiority or Other|||||||0.5|||||||Fisher Exact||||
1746711|NCT00388297|3210506|Superiority or Other|||||||0.5|||||||Fisher Exact||||
1746712|NCT00388297|3210506|Superiority or Other|||||||1|||||||Fisher Exact||||
1746713|NCT00388297|3210507|Superiority or Other|||||||1|||||||Fisher Exact||||
1746714|NCT00388297|3210508|Superiority or Other|||||||0.75|||||||Chi-squared||||
1746715|NCT00388297|3210508|Superiority or Other|||||||0.45|||||||Chi-squared||||
1746716|NCT00388297|3210509|Superiority or Other|||||||0.19|||||||Wilcoxon (Mann-Whitney)||||
1746717|NCT00388297|3210509|Superiority or Other|||||||0.46|||||||Wilcoxon (Mann-Whitney)||||
1746718|NCT00388297|3210510|Superiority or Other|||||||0.68|||||||Chi-squared||||
1746719|NCT00388297|3210510|Superiority or Other|||||||0.45|||||||Chi-squared||||
1746720|NCT00388297|3210511|Superiority or Other|||||||0.97|||||||Chi-squared||||
1746721|NCT00388297|3210511|Superiority or Other|||||||0.24|||||||Chi-squared||||
1746722|NCT00388297|3210512|Superiority or Other|||||||0.45|||||||Chi-squared|||Apgar < 7 at 5 minutes|
1746723|NCT00388297|3210512|Superiority or Other|||||||0.69|||||||Chi-squared|||Apgar < 7 at 5 minutes|
1746724|NCT00388297|3210512|Superiority or Other|||||||0.76|||||||Chi-squared|||Apgar > 4 at 1 minute|
1746725|NCT00388297|3210512|Superiority or Other|||||||0.76|||||||Chi-squared|||Apgar at 1 min < 4|
1746726|NCT00388297|3210513|Superiority or Other|||||||1|||||||Chi-squared||||
1746727|NCT00388297|3210513|Superiority or Other|||||||0.5|||||||Chi-squared||||
1746728|NCT00388297|3210514|Superiority or Other|||||||0.28|||||||Chi-squared||||
1746729|NCT00388297|3210514|Superiority or Other|||||||0.36|||||||Chi-squared||||
1746730|NCT00388297|3210515|Superiority or Other|||||||0.55|||||||Chi-squared||||
1746731|NCT00388297|3210515|Superiority or Other|||||||0.24|||||||Chi-squared||||
1746732|NCT00388297|3210516|Superiority or Other|||||||0.62|||||||Chi-squared||||
1746733|NCT00388297|3210516|Superiority or Other|||||||0.66|||||||Chi-squared||||
1746734|NCT00388297|3210517|Superiority or Other|||||||0.64|||||||Chi-squared||||
1746735|NCT00388297|3210517|Superiority or Other|||||||0.76|||||||Chi-squared||||
1746736|NCT00388297|3210518|Superiority or Other|||||||0.51|||||||Chi-squared||||
1746737|NCT00388297|3210518|Superiority or Other|||||||0.69|||||||Chi-squared||||
1746738|NCT00388297|3210519|Superiority or Other|||||||1|||||||Chi-squared||||
1746739|NCT00388297|3210519|Superiority or Other|||||||0.12|||||||Chi-squared||||
1746740|NCT00388297|3210520|Superiority or Other||Hodges–Lehmann|0.0||||0.98|2-Sided|95.0|-2.0|2.0|||Chi-squared||||
1746741|NCT00388297|3210520|Superiority or Other||Hodges–Lehmann|0.0||||0.37|2-Sided|95.0|-1.0|2.0|||Chi-squared||||
1746742|NCT00388297|3210521|Superiority or Other||Hodges–Lehmann|-1.0||||0.44|2-Sided|95.0|-3.0|1.0|||Chi-squared|||CBCL at 60 months|
1746743|NCT00388297|3210521|Superiority or Other||Hodges–Lehmann|0.0||||0.65|2-Sided|95.0|-2.0|2.0|||Chi-squared|||CBCL at 36 months|
1746744|NCT00388297|3210521|Superiority or Other||Hodges–Lehmann|0.0||||0.96|2-Sided|95.0|-2.0|2.0|||Chi-squared|||CBCL at 60 months|
1746745|NCT00388297|3210521|Superiority or Other||Hodges–Lehmann|0.0||||0.99|2-Sided|95.0|-2.0|2.0|||Chi-squared|||CBCL at 36 months|
1746746|NCT00388297|3210522|Superiority or Other||Hodges–Lehmann|0.0||||0.59|2-Sided|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (24 months)|
1746747|NCT00388297|3210522|Superiority or Other||Hodges–Lehmann|0.0||||0.48|2-Sided|95.0|0.0|3.0|||Chi-squared|||Bayley-III Language (12 months)|
1746748|NCT00388297|3210522|Superiority or Other||Hodges–Lehmann|0.0||||0.83|2-Sided|95.0|0.0|3.0|||Chi-squared|||Bayley II Motor (12 mo)|
1746749|NCT00388297|3210522|Superiority or Other||Hodges–Lehmann|0.0||||0.63|2-Sided|95.0|0.0|0.0|||Chi-squared|||Bayley II Cognitive (12 months)|
1746757|NCT00388297|3210525|Superiority or Other||Hodges–Lehmann|0.0||||0.89|2-Sided|95.0|-3.0|2.0|||Chi-squared||||
1746758|NCT00388297|3210526|Superiority or Other||Hodges–Lehmann|0.0||||0.71|2-Sided|95.0|-3.0|2.0|||Chi-squared|||Bayley-II Language (24 months)|
1746759|NCT00388297|3210526|Superiority or Other||Hodges–Lehmann|0.0||||0.2|2-Sided|95.0|-3.0|0.0|||Chi-squared|||Bayley-III Motor (24 months)|
1746760|NCT00388297|3210526|Superiority or Other||Hodges–Lehmann|0.0||||0.7|2-Sided|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (24 months)|
1746761|NCT00388297|3210526|Superiority or Other||Hodges–Lehmann|0.0||||0.92|2-Sided|95.0|-3.0|3.0|||Chi-squared|||Bayley-III Language (12 months)|
1746762|NCT00388297|3210526|Superiority or Other||Hodges–Lehmann|0.0||||0.54|2-Sided|95.0|0.0|3.0|||Chi-squared|||Bayley-III Motor (12 months)|
1746763|NCT00388297|3210526|Superiority or Other||Hodges–Lehmann|0.0||||0.89|2-Sided|95.0|0.0|0.0|||Chi-squared|||Bayley-III Cognitive (12 months)|
1746764|NCT00388297|3210526|Superiority or Other||Hodges–Lehmann|0.0||||0.3|2-Sided|95.0|0.0|3.0|||Chi-squared|||Bayley-II Language (24 months)|
1746765|NCT00388297|3210526|Superiority or Other||Hodges–Lehmann|0.0||||0.31|2-Sided|95.0|0.0|3.0|||Chi-squared|||Bayley-III Motor (24 months)|
1746766|NCT00388297|3210526|Superiority or Other|||||||0.11|||||||Chi-squared|||Analysis for < 37 weeks|
1746767|NCT00388297|3210526|Superiority or Other|||||||0.44|||||||Chi-squared|||Analysis for <37 weeks|
1746768|NCT00388297|3210526|Superiority or Other|||||||0.47|||||||Chi-squared|||Analysis for <34 weeks|
1746769|NCT00388297|3210526|Superiority or Other|||||||0.81|||||||Chi-squared|||Analysis for < 34 weeks|
1746770|NCT00388297|3210527|Superiority or Other|||||||0.46|||||||Wilcoxon (Mann-Whitney)||||
1746771|NCT00388297|3210527|Superiority or Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)||||
1746772|NCT00388297|3210528|Superiority or Other||Hodges-Lehmann estimate|-1.0||||0.3|2-Sided|95.0|-4.0|1.0|||Wilcoxon (Mann-Whitney)||||
1746773|NCT00388297|3210528|Superiority or Other||Hodges-Lehmann estimate|0.0||||0.71|2-Sided|95.0|-3.0|2.0|||Wilcoxon (Mann-Whitney)||||
1746774|NCT00387881|3210543|Superiority or Other||Percent difference|15.0|||<|0.001||95.0|8.0|22.0|||Cochran-Mantel-Haenszel||Analysis for Sustained Pain Free from 2-24 hours Post-dose|Sustained Pain-Free (2-24 hours)|
1746775|NCT00387881|3210543|Superiority or Other||Percent difference|18.0|||<|0.001||95.0|10.0|25.0||Endpoints were co-primary and both needed to have p-value of <0.05 to be considered indicative of efficacy.|Cochran-Mantel-Haenszel||Analysis for Migraine Pain-Free at 2 hours Post-Dose|Pain-Free (2 hours)|
1746776|NCT00387712|3210570|Other|Analysis of variance between groups across time is the primary analyses.||||||0.81||||||Group (high velocity training vs. low velocity duration training) by time (baseline to post-6 months) for the secondary outcome category (30 ft walk time - fastest comfortable gait) using repeated measures analysis of variance.|ANOVA|No other adjustments such as degrees of freedom was necessary.||Primary analyses is a group by time analysis of variance in 30 foot walk time (sec) between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points.|
1746777|NCT00387712|3210571|Other|Primary analyses is a group by time analysis of variance in myosin heavy chain levels levels between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points.||||||0.11|||||||ANOVA|||Power Calculation: It was calculated that 22 participants should be randomized to 2 groups to achieve a significant time by group interaction for myosin heavy chain isoforms for high-velocity or low velocity duration training groups, assuming a power of 90 percent power and alpha = 0.01, two-tailed analyses.|
1746778|NCT00387712|3210572|Other|Analysis of variance between groups across time is the primary analyses.||||||0.001||||||Group (high velocity training vs. low velocity duration training) by time (baseline to post-6 months) for the primary outcome category (peak fitness) using repeated measures analysis of variance. No adjustment for multiple comparisons is needed.|ANOVA|No other adjustments such as degrees of freedom was necessary.||"Power Calculation: It was calculated that 29 subjects should be randomized to 2 groups to achieve a significant time by group interaction for peak fitness for high-velocity or low velocity duration training groups, assuming a power of 90 percent power and alpha = 0.01, two-tailed analyses.~Primary analyses is a group by time analysis of variance in peak fitness levels between the higher-intensity and lower intensity training groups across baseline to 6 months post-exercise time points."|
1746779|NCT00387621|3210588|Superiority or Other||||||<|0.05|||||||rank-sum test|Rank-sum test was used due to non-normality of data with Bonferroni correction for multiple comparisons|||
1746780|NCT00387621|3210589|Superiority or Other||||||<|0.05|||||||t-test, 1 sided|With Bonferroni correction for multiple comparisons|||
1746781|NCT00387465|3210600|Other|The maximum tolerated dose (MTD) was derived from the number of participants experiencing dose-limiting toxicities in the Phase I arms. The MTD was the dose at which ≤30% of patients experienced DLTs during cycle 1 up to a pre-specified maximal dose of 40 mg/m2 of azacitidine.|Maximum Tolerated Dose|40.0|||||2-Sided||||||||MTD of Azacitidine measured in mg/m^2||
1746782|NCT00387127|3210619|Superiority or Other||Difference in overall response rate|16.3||||0.1969|2-Sided|95.0|-8.6|42.1||From exact test that common odds ratio equals 1|Fisher Exact||Overall response was defined as the percentage of participants achieving a PR or CR as determined by the investigator.||
1746783|NCT00387127|3210628|Superiority or Other||Difference in percentage of par. with CR|28.8||||0.013|2-Sided|95.0|5.7|53.6||From exact test that common odds ratio equals 1|Fisher Exact||Complete response was defined as the percentage of participants achieving a CR as determined by the investigator.||
1746784|NCT00387127|3210629|Superiority or Other||Difference in percentage of par. with CR|10.7||||0.3658|2-Sided|95.0|-13.4|37.3||From exact test that common odds ratio equals 1|Fisher Exact||Complete response was defined as the percentage of participants achieving a CR as determined by an independent radiological review.||
1746785|NCT00387088|3210649|Superiority or Other||Mean Difference (Final Values)|0.102|Standard Error of the Mean|0.009|<|0.0001|2-Sided|95.0|0.085|0.118|||ANCOVA|ANCOVA with pooled centre, LABA use, and treatment fitted as main effects and the baseline trough FEV1 as a covariate.|||
1746786|NCT00387036|3210650|Superiority or Other||Mean Difference (Final Values)|3.17|Standard Error of the Mean|1.9||||90.0|-0.28|6.61|||||||
1746787|NCT00387036|3210651|Superiority or Other||Mean Difference (Final Values)|-0.92|Standard Error of the Mean|0.37||||90.0|-1.59|-0.25|||||||
1746788|NCT00387010|3210670|Superiority or Other||Mean Difference (Net)|-1.6||||0.3223|2-Sided|95.0|-4.64|1.54|||t-test, 2 sided||||
1746789|NCT00386880|3210671|Superiority or Other|||||||0.59||||||Fisher's exact test.|Fisher Exact|||During the acute migraine attack, 90% of allodynic subjects and 75% of subjects without allodynia had phonophobia.|
1746790|NCT00386477|3210687|Superiority or Other||Risk Ratio (RR)|0.55||||0.11||95.0|0.26|1.11|||Chi-squared, Corrected||||
1746791|NCT00386425|3210689|Superiority or Other|||||||0.815||||||p-value is for Hospital Mortality|Fisher Exact||||
1746792|NCT00386425|3210689|Superiority or Other|||||||0.622||||||p-value is for 28-Day Mortality, Dead at Day 28 vs. Alive at Day 28|Pearson's chi-square test||||
1746793|NCT00386425|3210690|Superiority or Other||||||<|0.0001||||||p-value is for difference between participants normalizing protein C and not normalizing protein C.|Fisher Exact||||
1746794|NCT00386425|3210692|Superiority or Other|||||||0.341||||||p-value is for difference in liver SOFA between alternative and standard therapy|t-test, 2 sided||||
1746795|NCT00386425|3210692|Superiority or Other|||||||0.274||||||p-value is for difference in hematology SOFA between alternative and standard therapy|t-test, 2 sided||||
1746796|NCT00386425|3210692|Superiority or Other|||||||0.367||||||p-value is for difference in renal SOFA between alternative and standard therapy|t-test, 2 sided||||
1746797|NCT00386425|3210692|Superiority or Other|||||||0.082||||||p-value is for difference in respiratory SOFA between alternative and standard therapy|t-test, 2 sided||||
1746798|NCT00386425|3210692|Superiority or Other|||||||0.268||||||p-value is for difference in cardiovascular SOFA between alternative and standard therapy|t-test, 2 sided||||
1746799|NCT00386425|3210692|Superiority or Other|||||||0.19||||||p-value is for total SOFA difference between alternative and standard therapy|t-test, 2 sided||||
1746800|NCT00386425|3210693|Superiority or Other|||||||0.09||||||p-value is for Day 90 mortality|Fisher Exact||||
1746801|NCT00386425|3210694|Superiority or Other|||||||0.03||||||p-value is for Day 28 mortality|Fisher Exact||||
1746802|NCT00386425|3210695|Superiority or Other|||||||0.063||||||p-value is for the severe Protein C Deficiency (difference in change of pc between alt and standard groups)|t-test, 2 sided||||
1746803|NCT00386425|3210695|Superiority or Other|||||||0.047||||||p-value is for the moderate Protein C Deficiency (difference in change of pc between alt and standard groups)|t-test, 2 sided||||
1746804|NCT00386425|3210696|Superiority or Other|||||||0.011||||||p-value is for change to Day 7|t-test, 2 sided||||
1746805|NCT00386360|3210697|Superiority or Other||LS Mean Difference|0.092||||0.1385|2-Sided|95.0|-0.03|0.213|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746806|NCT00386360|3210698|Superiority or Other||LS Mean Difference|-40.269|||<|0.0001|2-Sided|95.0|-51.3|-29.238|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746807|NCT00386360|3210699|Superiority or Other||LS Mean Difference|-39.54||||0.0002|2-Sided|95.0|-59.957|-19.123|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746808|NCT00386360|3210700|Superiority or Other||LS Mean Difference|1.458||||0.0087|2-Sided|95.0|0.375|2.541|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746809|NCT00386360|3210701|Superiority or Other||LS Mean Difference|1.408||||0.0036|2-Sided|95.0|0.469|2.348|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746810|NCT00386360|3210702|Superiority or Other||LS Mean Difference|1.444|||<|0.0001|2-Sided|95.0|0.748|2.14|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746826|NCT00386334|3210740|Superiority or Other|||||||0.301||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746811|NCT00386360|3210703|Superiority or Other||LS Mean Difference|3.27|||<|0.0001|2-Sided|95.0|2.231|4.31|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746812|NCT00386360|3210704|Superiority or Other||LS Mean Difference|-0.06||||0.9212|2-Sided|95.0|-1.258|1.138|||ANOVA|LS means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746813|NCT00386360|3210705|Superiority or Other||LS Mean Difference|0.611||||0.0614|2-Sided|95.0|-0.03|1.252|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746814|NCT00386360|3210706|Superiority or Other||LS Mean Difference|0.334||||0.4565|2-Sided|95.0|-0.551|1.219|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746815|NCT00386360|3210707|Superiority or Other||LS Mean Difference|0.664||||0.336|2-Sided|95.0|-0.697|2.025|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746816|NCT00386360|3210708|Superiority or Other||LS Mean Difference|0.485||||0.1275|2-Sided|95.0|-0.141|1.11|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746817|NCT00386360|3210709|Superiority or Other||LS Mean Difference|0.543||||0.2973|2-Sided|95.0|-0.485|1.571|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746818|NCT00386360|3210710|Superiority or Other||LS Mean Difference|0.231||||0.7096|2-Sided|95.0|-0.995|1.458|||ANOVA|LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.||In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.|
1746819|NCT00386334|3210719|Superiority or Other||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746820|NCT00386334|3210722|Superiority or Other|||||||0.0634||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746821|NCT00386334|3210725|Superiority or Other|||||||0.2967||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746822|NCT00386334|3210728|Superiority or Other|||||||0.0765||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746823|NCT00386334|3210731|Superiority or Other|||||||0.2643||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746824|NCT00386334|3210734|Superiority or Other|||||||0.0803||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746825|NCT00386334|3210737|Superiority or Other|||||||0.78||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746827|NCT00386334|3210743|Superiority or Other|||||||0.1182||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA||||
1746828|NCT00386334|3210746|Superiority or Other|||||||0.0717||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746829|NCT00386334|3210749|Superiority or Other|||||||0.1175||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746830|NCT00386334|3210752|Superiority or Other||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746831|NCT00386334|3210755|Superiority or Other||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746832|NCT00386334|3210758|Superiority or Other||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746833|NCT00386334|3210761|Superiority or Other||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746834|NCT00386334|3210764|Superiority or Other||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746835|NCT00386334|3210767|Superiority or Other||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746836|NCT00386334|3210770|Superiority or Other|||||||0.0005||||||Multiple comparisons not applied due to only two treatments in study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746837|NCT00386334|3210773|Superiority or Other||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746838|NCT00386334|3210776|Superiority or Other|||||||0.0014||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746839|NCT00386334|3210779|Superiority or Other||||||<|0.0001||||||Multiple comparisons not applied due to only two treatments in the study.|ANCOVA|ANCOVA with treatment and site type as fixed effects and the baseline as a covariate|||
1746840|NCT00386256|3210784|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.|
1746841|NCT00386256|3210785|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Statistical analyses included descriptive statistics to assess demographic and medical characteristics, safety, text messaging or phone adherence, exercise adherence, and patient satisfaction. T-tests were used to determine significant differences between the HB text messaging and telephone groups (with inpatients and outpatients combined within each group). All analyses were conducted using SPSS version 14.0 for Windows.|
1746842|NCT00386100|3210797|Superiority or Other||Percent difference from metformin|3.75||||0.6749|2-Sided|95.0|-13.09|23.85||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746843|NCT00386100|3210797|Superiority or Other||Percent difference from metformin|-13.51||||0.1956|2-Sided|95.0|-30.35|8.31||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746844|NCT00386100|3210797|Superiority or Other||Percent difference from metformin|0.72||||0.9115|2-Sided|95.0|-11.39|14.48||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746845|NCT00386100|3210797|Superiority or Other||Percent difference from metformin|-6.26||||0.362|2-Sided|95.0|-18.62|7.97||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746846|NCT00386100|3210797|Superiority or Other||Percent difference from metformin|-2.83||||0.5176|2-Sided|95.0|-10.97|6.06||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746847|NCT00386100|3210798|Superiority or Other||Percent difference from metformin|-7.5||||0.3897|2-Sided|95.0|-23.0|11.0||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746848|NCT00386100|3210798|Superiority or Other||Percent difference from metformin|4.6||||0.7435|2-Sided|95.0|-21.2|38.7||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746849|NCT00386100|3210798|Superiority or Other||Percent difference from metformin|-0.8||||0.9122|2-Sided|95.0|-14.0|14.5||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1747778|NCT00380081|3211752|Superiority or Other|||||||0.012||||||Treatment effect|Cochran-Mantel-Haenszel||||
1746850|NCT00386100|3210798|Superiority or Other||Percent difference from metformin|1.0||||0.9125|2-Sided|95.0|-15.3|20.4||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746851|NCT00386100|3210798|Superiority or Other||Percent difference from metformin|-3.0||||0.5595|2-Sided|95.0|-12.3|7.4||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746852|NCT00386100|3210799|Superiority or Other||Percent difference from metformin|-4.3||||0.7195|2-Sided|95.0|-25.4|22.7||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746853|NCT00386100|3210799|Superiority or Other||Percent difference from metformin|32.1||||0.1381|2-Sided|95.0|-9.5|92.7||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746854|NCT00386100|3210799|Superiority or Other||Percent difference from metformin|4.0||||0.7065|2-Sided|95.0|-15.3|27.6||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746855|NCT00386100|3210799|Superiority or Other||Percent difference from metformin|12.3||||0.3791|2-Sided|95.0|-13.7|46.1||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746856|NCT00386100|3210799|Superiority or Other||Percent difference from metformin|5.7||||0.486|2-Sided|95.0|-9.6|23.6||Overall, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746857|NCT00386100|3210800|Superiority or Other||Percent difference from metformin|1.929||||0.8474|2-Sided|95.0|-17.015|25.198||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746858|NCT00386100|3210800|Superiority or Other||Percent difference from metformin|30.211||||0.6403|2-Sided|95.0|-61.586|341.371||Pre-menopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746859|NCT00386100|3210800|Superiority or Other||Percent difference from metformin|7.527||||0.7041|2-Sided|95.0|-26.773|57.892||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746860|NCT00386100|3210801|Superiority or Other||Percent difference from metformin|4.7614||||0.8337|2-Sided|95.0|-34.4741|67.4901||Postmenopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746861|NCT00386100|3210801|Superiority or Other||Percent difference from metformin|-1.0031||||0.9587|2-Sided|95.0|-35.928|52.959||Pre-menopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746862|NCT00386100|3210801|Superiority or Other||Percent difference from metformin|8.8777||||0.5816|2-Sided|95.0|-20.2636|48.6692||Females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746863|NCT00386100|3210801|Superiority or Other||Percent difference from metformin|-10.1648||||0.5118|2-Sided|95.0|-35.6298|25.3742||Males, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746864|NCT00386100|3210801|Superiority or Other||Percent difference from metformin|1.2168||||0.9069|2-Sided|95.0|-17.6057|24.3392||Overall population, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746865|NCT00386100|3210802|Superiority or Other||Percent difference from metformin|3.344||||0.88|2-Sided|95.0|-34.853|63.935||Postmenopausal females, Week 80. Log transformed.|ANCOVA|.Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746866|NCT00386100|3210802|Superiority or Other||Percent difference from metformin|8.19||||0.7889|2-Sided|95.0|-43.839|108.422||Pre-menopausal females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746867|NCT00386100|3210802|Superiority or Other||Percent difference from metformin|2.986||||0.8378|2-Sided|95.0|-22.997|37.735||Females, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746868|NCT00386100|3210802|Superiority or Other||Percent difference from metformin|0.328||||0.974|2-Sided|95.0|-18.308|23.214||Males, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746869|NCT00386100|3210802|Superiority or Other||Percent difference from metformin|1.467||||0.8682|2-Sided|95.0|-14.785|20.818||Overall population, Week 80. Log transformed.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746870|NCT00386100|3210803|Superiority or Other||Percent difference from metformin|-0.155||||0.9154|2-Sided|95.0|-3.037|2.814||Postmenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746871|NCT00386100|3210803|Superiority or Other||Percent difference from metformin|-0.638||||0.5908|2-Sided|95.0|-3.043|1.826||Premenopausal females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746872|NCT00386100|3210803|Superiority or Other||Percent difference from metformin|-0.452||||0.6223|2-Sided|95.0|-2.253|1.382||Females, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746873|NCT00386100|3210803|Superiority or Other||Percent difference from metformin|0.745||||0.4155|2-Sided|95.0|-1.064|2.587||Males, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746874|NCT00386100|3210803|Superiority or Other||Percent difference from metformin|0.168||||0.7895|2-Sided|95.0|-1.066|1.417||Overall population, Week 80. Log transformed. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline.|||
1746875|NCT00386100|3210804|Superiority or Other||Mean Difference (Net)|-0.5||||0.4153|2-Sided|95.0|-1.8|0.8||postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746876|NCT00386100|3210804|Superiority or Other||Median Difference (Net)|-5.5||||0.2526|2-Sided|95.0|-16.4|5.4||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746877|NCT00386100|3210804|Superiority or Other||Mean Difference (Net)|-1.0||||0.4199|2-Sided|95.0|-3.4|1.5||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746878|NCT00386100|3210804|Superiority or Other||Mean Difference (Net)|0.2||||0.6767|2-Sided|95.0|-0.7|1.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746879|NCT00386100|3210804|Superiority or Other||Median Difference (Net)|-0.2||||0.7015|2-Sided|95.0|-1.5|1.0||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746880|NCT00386100|3210805|Superiority or Other||Mean Difference (Net)|0.3||||0.877|2-Sided|95.0|-3.5|4.0||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746881|NCT00386100|3210805|Superiority or Other||Mean Difference (Net)|-1.4||||0.4861|2-Sided|95.0|-5.8|2.9||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746882|NCT00386100|3210805|Superiority or Other||Mean Difference (Net)|0.0||||0.9735|2-Sided|95.0|-2.4|2.3||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746883|NCT00386100|3210805|Superiority or Other||Mean Difference (Net)|-0.9||||0.3445|2-Sided|95.0|-2.9|1.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746884|NCT00386100|3210805|Superiority or Other||Mean Difference (Net)|-0.4||||0.6102|2-Sided|95.0|-1.9|1.1||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746885|NCT00386100|3210806|Superiority or Other||Mean Difference (Net)|-0.9||||0.384|2-Sided|95.0|-2.8|1.1||postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746886|NCT00386100|3210806|Superiority or Other||Median Difference (Net)|-1.2||||0.2259|2-Sided|95.0|-3.2|0.8||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746887|NCT00386100|3210806|Superiority or Other||Mean Difference (Net)|-0.9||||0.1776|2-Sided|95.0|-2.2|0.4||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746888|NCT00386100|3210806|Superiority or Other||Median Difference (Net)|-0.7||||0.3117|2-Sided|95.0|-2.2|0.7||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746889|NCT00386100|3210806|Superiority or Other||Median Difference (Net)|-0.7||||0.126|2-Sided|95.0|-1.7|0.2||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746890|NCT00386100|3210807|Superiority or Other||Mean Difference (Net)|-2.5||||0.1369|2-Sided|95.0|-3.9|1.7||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746891|NCT00386100|3210807|Superiority or Other||Mean Difference (Net)|-3.1||||0.0613|2-Sided|95.0|-6.3|0.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746892|NCT00386100|3210807|Superiority or Other||Mean Difference (Net)|-1.8||||0.0547|2-Sided|95.0|-3.7|0.0||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746893|NCT00386100|3210807|Superiority or Other||Mean Difference (Net)|-2.4||||0.033|2-Sided|95.0|-4.6|-0.2||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746894|NCT00386100|3210807|Superiority or Other||Mean Difference (Net)|-1.5||||0.0512|2-Sided|95.0|-3.0|0.0||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746895|NCT00386100|3210807|Superiority or Other||Median Difference (Net)|-0.7||||0.0967|2-Sided|95.0|-1.5|0.1||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746896|NCT00386100|3210807|Superiority or Other||Mean Difference (Net)|-1.5||||0.0134|2-Sided|95.0|-2.7|-0.3||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746897|NCT00386100|3210807|Superiority or Other||Median Difference (Net)|-1.9||||0.0038|2-Sided|95.0|-3.2|-0.6||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746898|NCT00386100|3210808|Superiority or Other||Mean Difference (Net)|-1.5||||0.1854|2-Sided|95.0|-3.6|0.7||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746899|NCT00386100|3210808|Superiority or Other||Median Difference (Net)|-0.4||||0.587|2-Sided|95.0|-1.7|1.0||Premenopausal female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746900|NCT00386100|3210808|Superiority or Other||Mean Difference (Net)|-2.4||||0.0155|2-Sided|95.0|-4.4|-0.5||Premenopausal female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746901|NCT00386100|3210808|Superiority or Other||Median Difference (Net)|-2.2||||0.0296|2-Sided|95.0|-4.3|-0.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746902|NCT00386100|3210808|Superiority or Other||Mean Difference (Net)|-1.2||||0.057|2-Sided|95.0|-2.4|0.0||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746903|NCT00386100|3210808|Superiority or Other||Median Difference (Net)|-1.7||||0.0152|2-Sided|95.0|-3.1|-0.3||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746904|NCT00386100|3210808|Superiority or Other||Mean Difference (Net)|-0.8||||0.0337|2-Sided|95.0|-1.6|-0.1||Male population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746945|NCT00386022|3210826|Equivalence|null hypothesis will be accepted if there is no effect of estrogen on the LH response to GnRH in younger and older postmenopausal women|||||<|0.01||||||LH amplitude response with estrogen|Repeated measured ANCOVA||||
1746905|NCT00386100|3210808|Superiority or Other||Mean Difference (Net)|-1.0||||0.0272|2-Sided|95.0|-1.9|-0.1||Male population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746906|NCT00386100|3210808|Superiority or Other||Mean Difference (Net)|-1.3||||0.011|2-Sided|95.0|-2.3|-0.3||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746907|NCT00386100|3210808|Superiority or Other||Mean Difference (Net)|-0.6||||0.0618|2-Sided|95.0|-1.1|0.0||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746908|NCT00386100|3210808|Superiority or Other||Median Difference (Net)|-1.0||||0.011|2-Sided|95.0|-1.7|-0.2||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746909|NCT00386100|3210808|Superiority or Other||Mean Difference (Net)|-1.5||||0.0005|2-Sided|95.0|-2.3|-0.7||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746910|NCT00386100|3210809|Superiority or Other||Median Difference (Net)|-2.6||||0.002|2-Sided|95.0|-4.1|-1.0||Postmenopausal female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746911|NCT00386100|3210809|Superiority or Other||Mean Difference (Net)|-2.6||||0.0338|2-Sided|95.0|-4.9|-0.2||Postmenopausal female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746912|NCT00386100|3210809|Superiority or Other||Mean Difference (Net)|-3.3||||0.0161|2-Sided|95.0|-5.9|-0.6||Postmenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746913|NCT00386100|3210809|Superiority or Other||Mean Difference (Net)|-1.7||||0.2363|2-Sided|95.0|-4.6|1.2||Premenopausal female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746914|NCT00386100|3210809|Superiority or Other||Mean Difference (Net)|-2.2||||0.0005|2-Sided|95.0|-3.3|-1.0||Female population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746915|NCT00386100|3210809|Superiority or Other||Mean Difference (Net)|-2.3||||0.0045|2-Sided|95.0|-3.9|-0.7||Female population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746916|NCT00386100|3210809|Superiority or Other||Mean Difference (Net)|-2.9||||0.0015|2-Sided|95.0|-4.7|-1.2||Female population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746917|NCT00386100|3210809|Superiority or Other||Mean Difference (Net)|-1.7||||0.0954|2-Sided|95.0|-3.7|0.3||Male population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746918|NCT00386100|3210809|Superiority or Other||Mean Difference (Net)|-1.1||||0.0308|2-Sided|95.0|-2.0|-0.1||Overall population, Week 20. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746919|NCT00386100|3210809|Superiority or Other||Mean Difference (Net)|-1.6||||0.0031|2-Sided|95.0|-2.7|-0.6||Overall population, Week 56. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746920|NCT00386100|3210809|Superiority or Other||Mean Difference (Net)|-2.2||||0.0012|2-Sided|95.0|-3.5|-0.9||Overall population, Week 80. No adjustment for multiple comparisons. If the p value was significant at Week 80 a comparison was done at Week 56; if it was significant at Weeks 80 and 56, a comparison was done at Week 20.|ANCOVA|Based on ANCOVA with terms for treatment, region, pre-screening HbA1c strata, sex, baseline|||
1746921|NCT00386100|3210811|Superiority or Other||Mean Difference (Net)|80.85||||0.319|2-Sided|95.0|-79.035|240.744|||Repeated measures analysis|Repeated measures analysis with terms for baseline, region, treatment, gender, pre-screening Hb1AC, time, and treatment by time interaction|||
1746922|NCT00386100|3210812|Superiority or Other||percent difference from metformin|31.14|||<|0.001|2-Sided|95.0|14.82|49.78||HOMA-S. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline [BL]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)|||
1747625|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.39||0.6734||95.0|-0.96|0.62|||ANCOVA|||Evoke Pain Cycle 6|
1746923|NCT00386100|3210812|Superiority or Other||Percent difference from metformin|2.4|||<|0.7148|2-Sided|95.0|-9.87|16.34||HOMA-B. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline [BL]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)|||
1746924|NCT00386100|3210813|Superiority or Other||Median Difference (Net)|-0.229||||0.0006|2-Sided|95.0|-0.359|-0.099||No adjustment for multiple comparisons.|ANCOVA|ANCOVA with terms for treatment, region, gender, pre-screening HbA1c strata, and baseline|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model||
1746925|NCT00386100|3210814|Superiority or Other||Mean Difference (Net)|-33.7||||0.0042|2-Sided|95.0|-56.666|-0.99||No adjustment for multiple comparisons.|ANCOVA|ANCOVA with terms for treatment, region, gender, pre-screening HbA1c strata, and baseline.|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model||
1746926|NCT00386100|3210815|Superiority or Other||Percent difference from metformin|-11.308||||0.0342|2-Sided|95.0|-20.617|-0.899||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline [BL]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)|||
1746927|NCT00386100|3210816|Superiority or Other||Percent difference from metformin|-8.2||||0.138|2-Sided|95.0|-18.04|2.82||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline [BL]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)|||
1746928|NCT00386100|3210817|Superiority or Other||Percent difference from metformin|102.24|||<|0.0001|2-Sided|95.0|79.23|128.19||No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline [BL]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)|||
1746929|NCT00386100|3210818|Superiority or Other||Percent difference from metformin|0.743||||0.835|2-Sided|95.0|-6.056|8.035||Triglycerides. No adjustment for multiple comparisons. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline [BL]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)|||
1746930|NCT00386100|3210818|Superiority or Other||Percent difference from metformin|2.58||||0.072|2-Sided|95.0|-0.232|5.47||HDL cholesterol. No adjustment for multiple comparison. Log transformed.|ANCOVA|ANCOVA with log (value) minus log (baseline [BL]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)|||
1746931|NCT00386100|3210818|Superiority or Other||Percent difference from metformin|8.71||||0.056|2-Sided|95.0|2.486|15.304||LDL cholesterol. No adjustment for multiple comparisons. Log transformed|ANCOVA|ANCOVA with log (value) minus log (baseline [BL]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)|||
1746932|NCT00386100|3210818|Superiority or Other||Percent difference from metformin|5.97||||0.0006|2-Sided|95.0|2.522|9.526||Total cholesterol. No adjustment for multiple comparisons. Log transformed|ANCOVA|ANCOVA with log (value) minus log (baseline [BL]) as dependent variable. Terms for treatment, region, gender, pre-screening HbA1c strata, and log (BL)|||
1746933|NCT00386100|3210819|Superiority or Other||Hazard Ratio (HR)|0.58|||<|0.0001|2-Sided|95.0|0.45|0.74|||Regression, Cox|Cox proportional hazard regression with terms for treatment, region, baseline Hb1Ac strata, and gender|||
1746934|NCT00386100|3210820|Superiority or Other||Odds Ratio (OR)|3.33|||<|0.0001|2-Sided|95.0|2.25|4.92||FPG <=7 mmol/l|Regression, Logistic|Terms for treatment, region, gender, pre-screening Hb1Ac, and baseline with LOCF from Week 32.|Odds of having an FPG <=7 mmol/l at Week 80 on Avandamet compared to Metformin||
1746935|NCT00386100|3210820|Superiority or Other||Odds Ratio (OR)|4.47|||<|0.0001|2-Sided|95.0|2.94|6.81||FPG <=6.1 mmol/l|Regression, Logistic|Terms for treatment, region, gender, pre-screening Hb1Ac strata, and baseline with LOCF from Week 32.|Odds of having an FPG <=6.1 mmol/l at Week 80 on Avandamet compared to Metformin||
1746936|NCT00386100|3210821|Superiority or Other||Median Difference (Net)|-1.07|||<|0.001|2-Sided|95.0|-1.425|-0.71||No adjustment for multiple comparisons|ANCOVA|Terms for treatment, region, gender, pre-screening Hb1Ac strata, and baseline with LOCF from Week 32 for withdrawn participants or missing values|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model||
1746937|NCT00386100|3210822|Superiority or Other||Mean Difference (Net)|-1.15|||<|0.0001||95.0|-1.54|-0.77|||Repeated measures analysis|Terms for baseline, region, treatment, pre-screening Hb1Ac strata, gender, time, and treatment by time interaction|AVM mean change from baseline minus MET mean change from baseline based on repeated measures analysis model||
1746938|NCT00386100|3210823|Superiority or Other||Odds Ratio (OR)|2.59|||<|0.0001|2-Sided|95.0|1.75|3.81||Hb1AC < 7%|Regression, Logistic|Logistic reggression with terms for treatment, region, gender, and baseline Hb1AC with LOCF from Week 32|Odds of having an HbA1c <7% at Week 80 on Avandamet compared to Metformin||
1746939|NCT00386100|3210823|Superiority or Other||Odds Ratio (OR)|1.18|||<|0.0046|2-Sided|95.0|1.18|2.46||Hb1AC <= 6.5%|Regression, Logistic|Logistic reggression with terms for treatment, region, gender, and baseline Hb1AC with LOCF from Week 32.|Odds of having an HbA1c <= 6.5% at Week 80 on Avandamet compared to Metformin.||
1746940|NCT00386100|3210824|Superiority or Other||Mean Difference (Net)|-0.5|||<|0.0001|2-Sided|95.0|-0.69|-0.3||No adjustment for multiple comparisons|Repeated measures analysis|Repeated measures analysis with terms for baseline, region, treatment, gender, time, and treatment by time interaction|AVM mean change from baseline minus MET mean change from baseline based on repeated measures analysis model||
1746941|NCT00386100|3210825|Superiority or Other||Mean Difference (Net)|-0.49|||<|0.0001|2-Sided|95.0|-0.669|-0.305||No adjustment for multiple comparisons|ANCOVA|ANCOVA with terms for treatment, region, gender, and baseline value with LOCF from Week 32 for withdrawn participants or missing values|AVM mean change from baseline minus MET mean change from baseline based on ANCOVA model||
1746942|NCT00386022|3210826|Equivalence|The null hypothesis will be accepted if there is no effect of age on the effect of estrogen on the LH response to GnRH|||||=|0||||||LH amplitude response to estrogen with age|Repeated measures ANCOVA||||
1746943|NCT00386022|3210826|Equivalence|The null hypothesis will be accepted if there is no effect of age on the effect of estrogen on the FSH response to GnRH|||||<|0.02||||||FSH amplitude response to estrogen with age|Repeated measures ANCOVA||||
1746944|NCT00386022|3210826|Equivalence|The null hypothesis will be accepted if there is no effect of estrogen on the FSH response to GnRH in younger and older postmenopausal women|||||<|0.0001||||||FSH amplitude response with estrogen|Repeated measures ANCOVA||||
1746946|NCT00386022|3210827|Equivalence|null hypothesis will be accepted if there is no difference in the FSH response to GnRH between young and old postmenopausal women|||||<|0.005||||||FSH % change with age|Repeated measures ANCOVA||||
1746947|NCT00386022|3210827|Equivalence|null hypothesis will be accepted if there is no difference in the FSH response to GnRH as a function of dose in younger or older postmenopausal women|||||<|0.001||||||FSH % change with dose|Repeated measures ANCOVA||||
1746948|NCT00386022|3210827|Equivalence|null hypothesis will be accepted if there is no difference in the LH response to GnRH between younger and older postmenopausal women|||||<|0.03||||||LH % change with age|Repeated measures ANCOVA|||null hypothesis: there will be no difference in the LH and FSH responses to graded doses of GnRH between younger and older postmenopausal women|
1746949|NCT00386022|3210827|Equivalence|null hypothesis will be accepted if there is no difference in the LH response to GnRH as a function of dose in young or old postmenopausal women|||||<|0.001||||||LH % change with dose|Repeated measures ANCOVA||||
1746950|NCT00386009|3210829|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746951|NCT00386009|3210832|Superiority or Other|||||||0.113||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746952|NCT00386009|3210833|Superiority or Other|||||||0.09||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746953|NCT00386009|3210834|Superiority or Other|||||||0.838||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746954|NCT00386009|3210835|Superiority or Other|||||||0.427||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746955|NCT00386009|3210836|Superiority or Other|||||||0.609||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746956|NCT00386009|3210837|Superiority or Other|||||||0.838||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746957|NCT00386009|3210838|Superiority or Other|||||||0.34||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746958|NCT00386009|3210839|Superiority or Other|||||||0.864||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746959|NCT00386009|3210840|Superiority or Other|||||||0.4||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746960|NCT00386009|3210841|Superiority or Other|||||||0.837||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746961|NCT00386009|3210842|Superiority or Other|||||||0.113||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746962|NCT00386009|3210843|Superiority or Other|||||||0.626||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746963|NCT00386009|3210844|Superiority or Other|||||||0.068||||||P-value for Change from Baseline to 12 Week Endpoint. Change = Endpoint minus baseline.|ANOVA||||
1746964|NCT00385996|3210845|Other||% alive without disease at 25 months|72.7|||||2-Sided|95.0|54.1|91.3|||||Using the Kaplan-Meier method.|One arm study|
1746965|NCT00385996|3210846|Other||TTP [% without disease at 24 months]|63.6|||||2-Sided|95.0|43.4|83.8|||||Using the Kaplan-Meier method.|One arm study|
1746966|NCT00385996|3210848|Superiority or Other||||||<|0.01|||||||Binomial distribution|Binomial distribution and test proportion =0.50||One arm phase 2 trial. This study is designed to asses response rate and defined as the percentage of subjects achieving at least 50% tumor volume. One-sided alpha is set at no more than 5% and the power no less than 90%,and the null hypothesis of RR of less than 10% and alternative hypothesis of RR of greater than 30%, a total of 30 patients will be enrolled (Fleming 1982).At least 7 responders out of 30 patients are needed to reject the null hypothesis of a 10% RR.|
1746967|NCT00385944|3210852|Superiority or Other||Median Difference (Net)|17.52|||<|0.001|2-Sided|95.0|9.22|25.83|||t-test, 2 sided||||
1746968|NCT00385944|3210853|Superiority or Other||Mean Difference (Net)|-9.24||||0.008|2-Sided|95.0|-15.99|-2.49|||t-test, 2 sided||||
1746969|NCT00385944|3210854|Superiority or Other||Mean Difference (Net)|-0.6||||0.847||95.0|||||two-sided paired t-test|||Paired t-test for each arm separately|
1746970|NCT00385944|3210854|Superiority or Other||Mean Difference (Net)|-9.0||||0.011||95.0|||||two-sided paired t-test|||Paired t-test for each arm separately|
1746971|NCT00385944|3210855|Superiority or Other||Mean Difference (Net)|-35.5|||<|0.001||95.0|||||two-sided paired t-test||||
1746972|NCT00385944|3210857|Superiority or Other||Mean Difference (Net)|-54.44|||<|0.001|2-Sided|95.0|-70.87|-38.01|||Mixed Models Analysis||||
1746973|NCT00385944|3210858|Superiority or Other||Mean Difference (Net)|-16.83|||<|0.001|2-Sided|95.0|-23.05|-10.62|||Mixed Models Analysis||||
1746974|NCT00385944|3210859|Superiority or Other||Mean Difference (Net)|3.85||||0.123|2-Sided|95.0|-1.13|8.84|||Mixed Models Analysis||||
1746975|NCT00385944|3210860|Superiority or Other||Mean Difference (Net)|10.26||||0.015|2-Sided|95.0|2.17|18.34|||Mixed Models Analysis||||
1746976|NCT00385944|3210861|Superiority or Other||Mean Difference (Net)|12.69||||0.001|2-Sided|95.0|5.56|19.81|||Mixed Models Analysis||||
1746977|NCT00385944|3210862|Superiority or Other||Mean Difference (Net)|15.16|||<|0.001|2-Sided|95.0|7.05|23.26|||Mixed Models Analysis||||
1746978|NCT00385944|3210863|Superiority or Other||Mean Difference (Net)|-4.3||||0.001|2-Sided|95.0|-6.84|-1.76|||Mixed Models Analysis||||
1746979|NCT00385944|3210864|Superiority or Other||Mean Difference (Net)|-11.98|||<|0.001|2-Sided|95.0|-17.06|-6.9|||Mixed Models Analysis||||
1746980|NCT00385944|3210865|Superiority or Other||Mean Difference (Net)|-7.81|||<|0.001|2-Sided|95.0|-10.96|-4.65|||Mixed Models Analysis||||
1746981|NCT00385944|3210866|Superiority or Other||Mean Difference (Net)|-12.91|||<|0.001|2-Sided|95.0|-17.02|-8.81|||Mixed Models Analysis||||
1746982|NCT00385801|3210891|Superiority or Other|||||||0.86||||||The effect of treatment on intensity of craving was assessed and the threshold for statistical significance was p < 0.05|Mixed Models Analysis|F=0.03||Intensity of craving|
1747779|NCT00380081|3211753|Superiority or Other||||||<|0.004||||||Treatment effect|Cochran-Mantel-Haenszel||||
1746983|NCT00385736|3210908|Superiority or Other|||||||0.532||||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared||||
1746984|NCT00385736|3210909|Superiority or Other|||||||0.614||||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared||||
1746985|NCT00385736|3210910|Superiority or Other|||||||0.797||||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared||||
1746986|NCT00385736|3210911|Superiority or Other|||||||0.264||||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared||||
1746987|NCT00385736|3210912|Superiority or Other|||||||0.506||||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared||||
1746988|NCT00385736|3210913|Superiority or Other|||||||0.526||||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared||||
1746989|NCT00385736|3210914|Superiority or Other|||||||0.264||||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared||||
1746990|NCT00385736|3210915|Superiority or Other|||||||0.08||||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared||||
1746991|NCT00385736|3210916|Superiority or Other|||||||0.035||||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared||||
1746992|NCT00385736|3210917|Superiority or Other|||||||0.038||||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared||||
1746993|NCT00385736|3210918|Superiority or Other|||||||0.382||||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared||||
1746994|NCT00385736|3210919|Superiority or Other|||||||0.107||||||Ranked secondary analyses were carried out in hierarchical order (as presented) to handle the multiplicity issues and to control the overall alpha level of 0.05.|Chi-squared||||
1746995|NCT00385736|3210920|Superiority or Other|||||||0.833||||||The primary endpoint analysis was carried out in hierarchical order (as presented) to handle the multiplicity issues induced by the two adalimumab groups being compared to placebo and to control the overall alpha level of 0.05.|Chi-squared||||
1746996|NCT00385736|3210920|Superiority or Other|||||||0.031||||||The primary endpoint analysis was carried out in hierarchical order (as presented) to handle the multiplicity issues induced by the two adalimumab groups being compared to placebo and to control the overall alpha level of 0.05.|Chi-squared||||
1746997|NCT00385723|3210921|Superiority or Other||Difference in change from baseline|-0.2|Standard Error of the Mean|0.21||1|2-Sided|95.0|-0.61|0.21||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.|
1746998|NCT00385723|3210921|Superiority or Other||Difference in change from baseline|-0.23|Standard Error of the Mean|0.21||0.8|2-Sided|95.0|-0.64|0.18||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on the change from baseline to 4 months.|
1746999|NCT00385723|3210922|Superiority or Other||Difference in change from baseline|-0.43|Standard Error of the Mean|0.11||0.0002|2-Sided|95.0|-0.64|-0.22||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.|
1747000|NCT00385723|3210922|Superiority or Other||Difference in change from baseline|-0.41|Standard Error of the Mean|0.1||0.0003|2-Sided|95.0|-0.62|-0.21||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on change from baseline to 4 months.|
1747001|NCT00385723|3210923|Superiority or Other||Difference in change from baseline|-0.13|Standard Error of the Mean|0.04||0.004|2-Sided|95.0|-0.22|-0.052||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||2.5 g/d minus placebo|Comparison was made on the change from baseline to 4 months.|
1747002|NCT00385723|3210923|Superiority or Other||Difference in change from baseline|-0.11|Standard Error of the Mean|0.04||0.03|2-Sided|95.0|-0.19|-0.028||Bonferroni-adjusted to account for multiple testing.|Mixed Models Analysis||1.25 g/d minus placebo|Comparison was made on change from baseline to 4 months|
1747003|NCT00385671|3210926|Superiority or Other|||||||0.722||||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.|
1747004|NCT00385671|3210926|Superiority or Other|||||||0.72||||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.|
1747005|NCT00385671|3210926|Superiority or Other|||||||1||||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AlkPhos values.|
1747006|NCT00385671|3210926|Superiority or Other|||||||0.095||||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.|
1747007|NCT00385671|3210926|Superiority or Other|||||||0.121||||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated HbA1C values.|
1747008|NCT00385671|3210926|Superiority or Other|||||||1||||||P-value is for HbA1C. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated HbA1C values.|
1747009|NCT00385671|3210926|Superiority or Other|||||||0.325||||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.|
1747010|NCT00385671|3210926|Superiority or Other|||||||0.264||||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated FPG values.|
1747011|NCT00385671|3210926|Superiority or Other|||||||0.023||||||P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.|
1747012|NCT00385671|3210926|Superiority or Other|||||||1||||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.|
1747013|NCT00385671|3210926|Superiority or Other|||||||0.28||||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated GGT values.|
1747014|NCT00385671|3210926|Superiority or Other|||||||0.16||||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.|
1747015|NCT00385671|3210926|Superiority or Other|||||||0.245||||||P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated TBili values.|
1747016|NCT00385671|3210926|Superiority or Other|||||||0.498||||||P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated TBili values.|
1747017|NCT00385671|3210926|Superiority or Other|||||||0.44||||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.|
1747018|NCT00385671|3210926|Superiority or Other|||||||0.32||||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated ALT values.|
1747019|NCT00385671|3210926|Superiority or Other|||||||0.05||||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.|
1747020|NCT00385671|3210926|Superiority or Other|||||||0.75||||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.|
1747021|NCT00385671|3210926|Superiority or Other|||||||0.749||||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AST values.|
1747022|NCT00385671|3210926|Superiority or Other|||||||1||||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.|
1747051|NCT00385671|3210932|Superiority or Other|||||||0.06||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated heart rate.|
1747023|NCT00385671|3210927|Superiority or Other|||||||0.297||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.|
1747024|NCT00385671|3210927|Superiority or Other|||||||0.987||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.|
1747025|NCT00385671|3210927|Superiority or Other|||||||0.298||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.|
1747026|NCT00385671|3210928|Superiority or Other|||||||0.424||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.|
1747027|NCT00385671|3210928|Superiority or Other|||||||0.232||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.|
1747028|NCT00385671|3210928|Superiority or Other|||||||0.047||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.|
1747029|NCT00385671|3210929|Superiority or Other|||||||0.679||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in total bilirubin.|
1747030|NCT00385671|3210929|Superiority or Other|||||||0.505||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in total bilirubin.|
1747031|NCT00385671|3210929|Superiority or Other|||||||0.285||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 total bilirubin.|
1747032|NCT00385671|3210930|Superiority or Other|||||||0.134||||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.|
1747033|NCT00385671|3210930|Superiority or Other|||||||0.91||||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AlkPhos.|
1747034|NCT00385671|3210930|Superiority or Other|||||||0.169||||||P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.|
1747035|NCT00385671|3210930|Superiority or Other|||||||0.832||||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in GGT.|
1747155|NCT00385671|3210948|Superiority or Other|||||||0.107||||||P-value for Direct Treatment Effect. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for tests of direct and indirect effects.|Regression, Linear||||
1747036|NCT00385671|3210930|Superiority or Other|||||||0.847||||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in GGT.|
1747037|NCT00385671|3210930|Superiority or Other|||||||0.985||||||P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in GGT.|
1747038|NCT00385671|3210930|Superiority or Other|||||||0.675||||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in ALT.|
1747039|NCT00385671|3210930|Superiority or Other|||||||0.609||||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in ALT.|
1747040|NCT00385671|3210930|Superiority or Other|||||||0.928||||||P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in ALT.|
1747041|NCT00385671|3210930|Superiority or Other|||||||0.993||||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.|
1747042|NCT00385671|3210930|Superiority or Other|||||||0.051||||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AST.|
1747043|NCT00385671|3210930|Superiority or Other|||||||0.055||||||P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Variance model & t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AST.|
1747044|NCT00385671|3210931|Superiority or Other|||||||0.808||||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.|
1747045|NCT00385671|3210931|Superiority or Other|||||||0.034||||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent low body weight.|
1747046|NCT00385671|3210931|Superiority or Other|||||||0.103||||||P-value is for low. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent low body weight.|
1747047|NCT00385671|3210931|Superiority or Other|||||||0.622||||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.|
1747048|NCT00385671|3210931|Superiority or Other|||||||0.065||||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with treatment-emergent high body weight.|
1747049|NCT00385671|3210931|Superiority or Other|||||||0.332||||||P-value is for high. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of patients with treatment-emergent high body weight.|
1747050|NCT00385671|3210932|Superiority or Other|||||||0.596||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.|
1747052|NCT00385671|3210932|Superiority or Other|||||||0.281||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated heart rate.|
1747053|NCT00385671|3210933|Superiority or Other|||||||0.376||||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.|
1747054|NCT00385671|3210933|Superiority or Other|||||||0.502||||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.|
1747055|NCT00385671|3210933|Superiority or Other|||||||0.06||||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated systolic blood pressure.|
1747056|NCT00385671|3210933|Superiority or Other|||||||1||||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.|
1747057|NCT00385671|3210933|Superiority or Other|||||||1||||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.|
1747058|NCT00385671|3210933|Superiority or Other|||||||0.83||||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Fisher Exact|||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in the number of participants with elevated diastolic blood pressure.|
1747059|NCT00385671|3210934|Superiority or Other|||||||0.011||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.|
1747060|NCT00385671|3210934|Superiority or Other||||||<|0.001||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in body weight.|
1747061|NCT00385671|3210934|Superiority or Other||||||<|0.001||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in body weight.|
1747062|NCT00385671|3210935|Superiority or Other|||||||0.85||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.|
1747063|NCT00385671|3210935|Superiority or Other|||||||0.13||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in heart rate.|
1747064|NCT00385671|3210935|Superiority or Other|||||||0.078||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in heart rate.|
1747065|NCT00385671|3210936|Superiority or Other|||||||0.627||||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.|
1747380|NCT00384813|3211123|Superiority or Other||regression coefficient|0.33||||0.23||||||For both baseline to 4 month analyses (see above p value) and baseline to 10 month analyses, the variable of intervention group did not contribute significant additional variance.|Regression, Linear||||
1747066|NCT00385671|3210936|Superiority or Other|||||||0.911||||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.|
1747067|NCT00385671|3210936|Superiority or Other|||||||0.537||||||P-value is for systolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.|
1747068|NCT00385671|3210936|Superiority or Other|||||||0.021||||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.|
1747069|NCT00385671|3210936|Superiority or Other|||||||0.118||||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.|
1747070|NCT00385671|3210936|Superiority or Other|||||||0.448||||||P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.|
1747071|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.85|2-Sided|95.0|-0.72|0.59||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.|
1747072|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.07||||0.823|2-Sided|95.0|-0.57|0.72||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.|
1747073|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.14||||0.675|2-Sided|95.0|-0.5|0.78||P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.|
1747074|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.05||||0.871|2-Sided|95.0|-0.6|0.7||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.|
1747075|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.19||||0.569|2-Sided|95.0|-0.46|0.83||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.|
1747076|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.13||||0.681|2-Sided|95.0|-0.5|0.77||P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.|
1747156|NCT00385671|3210949|Superiority or Other|||||||0.954||||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.|
1747077|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.0||||0.992|2-Sided|95.0|-0.64|0.65||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.|
1747078|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.3||||0.351|2-Sided|95.0|-0.34|0.94||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.|
1747079|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.3||||0.349|2-Sided|95.0|-0.33|0.93||P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.|
1747080|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.01||||0.975|2-Sided|95.0|-0.62|0.64||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.|
1747081|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.34||||0.295|2-Sided|95.0|-0.29|0.97||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.|
1747082|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.33||||0.304|2-Sided|95.0|-0.3|0.95||P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.|
1747083|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.636|2-Sided|95.0|-0.79|0.49||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.|
1747084|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.27||||0.403|2-Sided|95.0|-0.37|0.91||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.|
1747085|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.43||||0.185|2-Sided|95.0|-0.2|1.06||P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.|
1747086|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.924|2-Sided|95.0|-0.65|0.59||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.|
1747087|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.21||||0.511|2-Sided|95.0|-0.41|0.83||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.|
1747381|NCT00384774|3211132|Superiority or Other (legacy)|||||||0.3364|||||||Fisher Exact|||Headache Response|
1747088|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.24||||0.447|2-Sided|95.0|-0.38|0.85||P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.|
1747089|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.05||||0.878|2-Sided|95.0|-0.58|0.67||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.|
1747090|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.12||||0.713|2-Sided|95.0|-0.5|0.74||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.|
1747091|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.07||||0.829|2-Sided|95.0|-0.55|0.68||P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.|
1747092|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.976|2-Sided|95.0|-0.62|0.6||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.|
1747093|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.23||||0.461|2-Sided|95.0|-0.38|0.84||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.|
1747094|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.24||||0.439|2-Sided|95.0|-0.37|0.84||P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.|
1747095|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.64|2-Sided|95.0|-0.73|0.45||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.|
1747096|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.944|2-Sided|95.0|-0.6|0.56||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.|
1747097|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.12||||0.688|2-Sided|95.0|-0.46|0.7||P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.|
1747098|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.193|2-Sided|95.0|-0.91|0.19||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.|
1747382|NCT00384774|3211132|Superiority or Other (legacy)|||||||0.1093|||||||Chi-squared|||Headache Response|
1747099|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.13||||0.634|2-Sided|95.0|-0.42|0.68||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.|
1747100|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.5||||0.075|2-Sided|95.0|-0.05|1.04||P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.|
1747101|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|-0.29||||0.257|2-Sided|95.0|-0.79|0.21||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.|
1747102|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.29||||0.257|2-Sided|95.0|-0.21|0.79||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.|
1747103|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.58||||0.025|2-Sided|95.0|0.07|1.09||P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.|
1747104|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.445|2-Sided|95.0|-0.6|0.26||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.|
1747105|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.18||||0.412|2-Sided|95.0|-0.25|0.62||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.|
1747106|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.35||||0.117|2-Sided|95.0|-0.09|0.79||P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.|
1747107|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.98||||0.059|2-Sided|95.0|-0.04|1.99||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.|
1747108|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|1.46||||0.005|2-Sided|95.0|0.44|2.47||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.|
1747109|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.48||||0.328|2-Sided|95.0|-0.49|1.45||P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.|
1747383|NCT00384774|3211132|Superiority or Other (legacy)|||||||0.1178|||||||Chi-squared|||Headache Response|
1747110|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.88||||0.086|2-Sided|95.0|-0.13|1.89||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.|
1747111|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|1.5||||0.004|2-Sided|95.0|0.49|2.51||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.|
1747112|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.62||||0.208|2-Sided|95.0|-0.35|1.58||P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.|
1747113|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.94||||0.066|2-Sided|95.0|-0.06|1.94||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.|
1747114|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|1.44||||0.005|2-Sided|95.0|0.45|2.44||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.|
1747115|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.51||||0.295|2-Sided|95.0|-0.44|1.46||P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.|
1747116|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.79||||0.114|2-Sided|95.0|-0.19|1.77||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.|
1747117|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|1.68|||<|0.001|2-Sided|95.0|0.7|2.66||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.|
1747118|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.89|||<|0.063|2-Sided|95.0|-0.05|1.82||P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.|
1747119|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.72|||<|0.157|2-Sided|95.0|-0.28|1.71||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.|
1747120|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|1.52|||<|0.003|2-Sided|95.0|0.53|2.51||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.|
1747860|NCT00379080|3211956|Other|||||||0.05|||||||Regression, Cox|||VEGFR2|
1747121|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.81|||<|0.093|2-Sided|95.0|-0.14|1.75||P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 8.|
1747122|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.66|||<|0.178|2-Sided|95.0|-0.3|1.63||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.|
1747123|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|1.65|||<|0.001|2-Sided|95.0|0.68|2.61||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.|
1747124|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.98|||<|0.036|2-Sided|95.0|0.06|1.91||P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.|
1747125|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.77|||<|0.119|2-Sided|95.0|-0.2|1.74||P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.|
1747126|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|1.56|||<|0.002|2-Sided|95.0|0.59|2.53||P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.|
1747127|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.79|||<|0.093|2-Sided|95.0|-0.13|1.71||P-value is for de novo, 6 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.|
1747128|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.85|||<|0.079|2-Sided|95.0|-0.1|1.79||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.|
1747129|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|1.7|||<|0.001|2-Sided|95.0|0.75|2.65||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.|
1747130|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.85|||<|0.065|2-Sided|95.0|-0.05|1.76||P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.|
1747131|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.68|||<|0.142|2-Sided|95.0|-0.23|1.58||P-value is for de nove, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.|
1747861|NCT00379080|3211956|Other|||||||0.01|||||||Regression, Cox|||sFLT_1|
1747132|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|1.51|||<|0.001|2-Sided|95.0|0.61|2.41||P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.|
1747133|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.83|||<|0.058|2-Sided|95.0|-0.03|1.69||P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.|
1747134|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.21|||<|0.619|2-Sided|95.0|-0.63|1.06||P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.|
1747135|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|1.12|||<|0.01|2-Sided|95.0|0.27|1.97||P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.|
1747136|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.91|||<|0.029|2-Sided|95.0|0.09|1.73||P-value is for de novo, week 3. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.|
1747137|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.12|||<|0.762|2-Sided|95.0|-0.66|0.9||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.|
1747138|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.83|||<|0.032|2-Sided|95.0|0.07|1.59||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.|
1747139|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.71|||<|0.058|2-Sided|95.0|-0.02|1.45||P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.|
1747140|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.33|||<|0.344|2-Sided|95.0|-0.35|1.0||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.|
1747141|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.49|||<|0.153|2-Sided|95.0|-0.18|1.16||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.|
1747142|NCT00385671|3210938|Superiority or Other||Mean Difference (Final Values)|0.16|||<|0.622|2-Sided|95.0|-0.48|0.8||P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment*Week+ Baseline*Week+Subgroup*Week+Subgroup*Treatment+Subgroup*Treatment*Week||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.|
1747862|NCT00379080|3211956|Other|||||||0.05|||||||Regression, Cox|||sFLT_1|
1747143|NCT00385671|3210939|Superiority or Other||Mean Difference (Final Values)|0.18||||0.594|2-Sided|95.0|-0.49|0.85||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.|
1747144|NCT00385671|3210939|Superiority or Other||Mean Difference (Final Values)|0.46||||0.172|2-Sided|95.0|-0.2|1.13||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.|
1747145|NCT00385671|3210939|Superiority or Other||Mean Difference (Final Values)|0.28||||0.365|2-Sided|95.0|-0.33|0.9||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week with participant is as a random effect, Kenward-Roger approximation.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.|
1747146|NCT00385671|3210941|Superiority or Other|||||||0.688||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.|
1747147|NCT00385671|3210941|Superiority or Other|||||||0.033||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.|
1747148|NCT00385671|3210941|Superiority or Other|||||||0.008||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.|
1747149|NCT00385671|3210944|Superiority or Other|||||||0.919||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.|
1747150|NCT00385671|3210944|Superiority or Other|||||||0.167||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.|
1747151|NCT00385671|3210944|Superiority or Other|||||||0.103||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Log Rank|Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.|
1747152|NCT00385671|3210947|Superiority or Other|||||||0.463||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.|
1747153|NCT00385671|3210947|Superiority or Other|||||||0.492||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.|
1747154|NCT00385671|3210947|Superiority or Other|||||||0.968||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.|
1747384|NCT00384774|3211132|Superiority or Other (legacy)|||||||0.4851|||||||Chi-squared|||Headache Response|
1747385|NCT00384774|3211132|Superiority or Other (legacy)|||||||0.0991|||||||Fisher Exact|||Headache Response|
1747157|NCT00385671|3210949|Superiority or Other|||||||0.114||||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.|
1747158|NCT00385671|3210949|Superiority or Other|||||||0.202||||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale somatomotor toxicity score.|
1747159|NCT00385671|3210949|Superiority or Other|||||||0.923||||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.|
1747160|NCT00385671|3210949|Superiority or Other|||||||0.69||||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.|
1747161|NCT00385671|3210949|Superiority or Other|||||||0.48||||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale cognitive toxicity score.|
1747162|NCT00385671|3210949|Superiority or Other|||||||0.936||||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.|
1747163|NCT00385671|3210949|Superiority or Other|||||||0.192||||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.|
1747164|NCT00385671|3210949|Superiority or Other|||||||0.13||||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with a categorial change from baseline to 12 weeks in the Portland Neurotoxicity Scale total score.|
1747165|NCT00385671|3210950|Superiority or Other|||||||0.341||||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.|
1747166|NCT00385671|3210950|Superiority or Other|||||||0.09||||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.|
1747167|NCT00385671|3210950|Superiority or Other|||||||0.43||||||P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.|
1747168|NCT00385671|3210950|Superiority or Other|||||||0.57||||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.|
1747360|NCT00384930|3211104|Superiority or Other||Mean Difference (Net)|-0.55||||0.016||95.0|-1.0|-0.1||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo||
1747169|NCT00385671|3210950|Superiority or Other|||||||0.505||||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.|
1747170|NCT00385671|3210950|Superiority or Other|||||||0.914||||||P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.|
1747171|NCT00385671|3210950|Superiority or Other|||||||0.47||||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.|
1747172|NCT00385671|3210950|Superiority or Other|||||||0.248||||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.|
1747173|NCT00385671|3210950|Superiority or Other|||||||0.645||||||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.|
1747174|NCT00385671|3210951|Superiority or Other|||||||0.338||||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747175|NCT00385671|3210951|Superiority or Other|||||||0.963||||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747176|NCT00385671|3210951|Superiority or Other|||||||0.498||||||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747177|NCT00385671|3210951|Superiority or Other|||||||0.713||||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747178|NCT00385671|3210951|Superiority or Other|||||||0.403||||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747179|NCT00385671|3210951|Superiority or Other|||||||0.712||||||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747180|NCT00385671|3210951|Superiority or Other|||||||0.457||||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747386|NCT00384774|3211132|Superiority or Other (legacy)|||||||1|||||||Fisher Exact|||Headache Response|
1747387|NCT00384189|3211166|Superiority or Other|||||||0.0002||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)||||
1747181|NCT00385671|3210951|Superiority or Other|||||||0.307||||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747182|NCT00385671|3210951|Superiority or Other|||||||0.782||||||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747183|NCT00385671|3210951|Superiority or Other|||||||0.899||||||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747184|NCT00385671|3210951|Superiority or Other|||||||0.725||||||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747185|NCT00385671|3210951|Superiority or Other|||||||0.696||||||p-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747186|NCT00385671|3210951|Superiority or Other|||||||0.784||||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747187|NCT00385671|3210951|Superiority or Other|||||||0.247||||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747188|NCT00385671|3210951|Superiority or Other|||||||0.379||||||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747189|NCT00385671|3210951|Superiority or Other|||||||0.435||||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747190|NCT00385671|3210951|Superiority or Other|||||||0.835||||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747191|NCT00385671|3210951|Superiority or Other|||||||0.694||||||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747192|NCT00385671|3210951|Superiority or Other|||||||0.803||||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747388|NCT00384189|3211166|Superiority or Other|||||||0.0006||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)||||
1747389|NCT00384189|3211166|Superiority or Other|||||||0.001||||||One-sided p-value for superiority, significance level 2.5%.|Wilcoxon (Mann-Whitney)||||
1747193|NCT00385671|3210951|Superiority or Other|||||||0.953||||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747194|NCT00385671|3210951|Superiority or Other|||||||0.682||||||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747195|NCT00385671|3210951|Superiority or Other|||||||0.489||||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747196|NCT00385671|3210951|Superiority or Other|||||||0.25||||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747197|NCT00385671|3210951|Superiority or Other|||||||0.024||||||p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747198|NCT00385671|3210951|Superiority or Other|||||||0.03||||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747199|NCT00385671|3210951|Superiority or Other|||||||0.412||||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747200|NCT00385671|3210951|Superiority or Other|||||||0.257||||||p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747201|NCT00385671|3210951|Superiority or Other|||||||0.133||||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747202|NCT00385671|3210951|Superiority or Other|||||||0.71||||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747203|NCT00385671|3210951|Superiority or Other|||||||0.226||||||p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747204|NCT00385671|3210951|Superiority or Other|||||||0.488||||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747390|NCT00384189|3211167|Superiority or Other|||||||0.1574||||||Two-sided p-value, significance level 5%.|Log Rank||||
1747391|NCT00384189|3211167|Superiority or Other|||||||0.0891||||||Two-sided p-value, significance level 5%.|Log Rank||||
1747863|NCT00379080|3211956|Other|||||||0.02|||||||Regression, Cox|||CAIX|
1747205|NCT00385671|3210951|Superiority or Other|||||||0.128||||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747206|NCT00385671|3210951|Superiority or Other|||||||0.554||||||p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747207|NCT00385671|3210951|Superiority or Other|||||||0.411||||||p-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747208|NCT00385671|3210951|Superiority or Other|||||||0.983||||||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747209|NCT00385671|3210951|Superiority or Other|||||||0.486||||||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Chi-squared|Pairwise p-values come from the Likelihood-Ratio Chi-squared test.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).|
1747210|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.112|2-Sided|95.0|-1.8|0.19||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.|
1747211|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|0.36||||0.497|2-Sided|95.0|-0.69|1.42||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.|
1747212|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|1.17||||0.026|2-Sided|95.0|0.14|2.2||P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.|
1747213|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.976|2-Sided|95.0|-0.71|0.69||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.|
1747214|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.119|2-Sided|95.0|-1.29|0.15||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.|
1747215|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.56||||0.12|2-Sided|95.0|-1.27|0.15||P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.|
1747361|NCT00384930|3211104|Superiority or Other||Mean Difference (Net)|-0.57||||0.013||95.0|-1.03|-0.12||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo||
1747864|NCT00379080|3211956|Other|||||||0.04|||||||Regression, Cox|||PIGF|
1747216|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.38||||0.386|2-Sided|95.0|-1.23|0.48||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.|
1747217|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.7|2-Sided|95.0|-1.1|0.74||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.|
1747218|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|0.2||||0.665|2-Sided|95.0|-0.7|1.09||P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.|
1747219|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|0.0||||0.99|2-Sided|95.0|-0.69|0.68||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.|
1747220|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.35||||0.334|2-Sided|95.0|-1.05|0.36||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.|
1747221|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.333|2-Sided|95.0|-1.04|0.35||P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.|
1747222|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.33||||0.423|2-Sided|95.0|-1.14|0.48||P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.|
1747223|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.51||||0.243|2-Sided|95.0|-1.37|0.35||P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.|
1747224|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.67|2-Sided|95.0|-1.02|0.66||p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.|
1747225|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|0.24||||0.461|2-Sided|95.0|-0.39|0.87||p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.|
1747247|NCT00385671|3210954|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.077|2-Sided|95.0|-1.12|0.06||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.|
1747226|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.798|2-Sided|95.0|-0.73|0.56||P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.|
1747227|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.32||||0.325|2-Sided|95.0|-0.96|0.32||P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.|
1747228|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|0.04||||0.885|2-Sided|95.0|-0.51|0.59||p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.|
1747229|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.881|2-Sided|95.0|-0.61|0.52||P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.|
1747230|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.767|2-Sided|95.0|-0.64|0.47||P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.|
1747231|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|0.1||||0.641|2-Sided|95.0|-0.32|0.52||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.|
1747232|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.715|2-Sided|95.0|-0.51|0.35||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.|
1747233|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.409|2-Sided|95.0|-0.61|0.25||P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.|
1747234|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.007|2-Sided|95.0|-0.98|-0.16||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.|
1747235|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.33||||0.141|2-Sided|95.0|-0.76|0.11||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.|
1747355|NCT00384930|3211103|Superiority or Other||||||<|0.001||||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel||||
1747392|NCT00384189|3211167|Superiority or Other|||||||0.1362||||||Two-sided p-value, significance level 5%.|Log Rank||||
1747236|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|0.24||||0.26|2-Sided|95.0|-0.18|0.67||P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.|
1747237|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|0.19||||0.228|2-Sided|95.0|-0.12|0.49||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.|
1747238|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|0.14||||0.39|2-Sided|95.0|-0.18|0.45||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.|
1747239|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.747|2-Sided|95.0|-0.36|0.26||P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.|
1747240|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-1.73||||0.218|2-Sided|95.0|-4.49|1.04||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.|
1747241|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-1.13||||0.45|2-Sided|95.0|-4.08|1.82||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.|
1747242|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|0.6||||0.682|2-Sided|95.0|-2.29|3.48||P-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.|
1747243|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|0.81||||0.444|2-Sided|95.0|-1.27|2.88||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.|
1747244|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-1.01||||0.353|2-Sided|95.0|-3.16|1.13||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.|
1747245|NCT00385671|3210952|Superiority or Other||Mean Difference (Final Values)|-1.82||||0.096|2-Sided|95.0|-3.96|0.32||P-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.|
1747246|NCT00385671|3210954|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.221|2-Sided|95.0|-0.95|0.22||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.|
1747248|NCT00385671|3210954|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.584|2-Sided|95.0|-0.76|0.43||P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.|
1747249|NCT00385671|3210954|Superiority or Other||Mean Difference (Final Values)|-0.41||||0.193|2-Sided|95.0|-1.04|0.21||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.|
1747250|NCT00385671|3210954|Superiority or Other||Mean Difference (Final Values)|-0.52||||0.102|2-Sided|95.0|-1.15|0.11||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.|
1747251|NCT00385671|3210954|Superiority or Other||Mean Difference (Final Values)|-0.11||||0.733|2-Sided|95.0|-0.75|0.52||P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 2 score.|
1747252|NCT00385671|3210954|Superiority or Other||Mean Difference (Final Values)|-0.74||||0.091|2-Sided|95.0|-1.59|0.12||P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.|
1747253|NCT00385671|3210954|Superiority or Other||Mean Difference (Final Values)|-0.75||||0.093|2-Sided|95.0|-1.63|0.13||P-value is for Item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.|
1747254|NCT00385671|3210954|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.974|2-Sided|95.0|-0.88|0.85||P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.|
1747255|NCT00385671|3210954|Superiority or Other||Mean Difference (Final Values)|-1.07||||0.221|2-Sided|95.0|-2.8|0.65||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.|
1747256|NCT00385671|3210954|Superiority or Other||Mean Difference (Final Values)|-1.5||||0.092|2-Sided|95.0|-3.24|0.24||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS total score.|
1747257|NCT00385671|3210954|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.635|2-Sided|95.0|-2.18|1.33||P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.|
1747258|NCT00385671|3210955|Superiority or Other|||||||0.408||||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.|
1747259|NCT00385671|3210955|Superiority or Other|||||||0.865||||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.|
1747865|NCT00379080|3211956|Other|||||||0.04|||||||Regression, Cox|||VEGFR2|
1747260|NCT00385671|3210955|Superiority or Other|||||||0.498||||||P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.|
1747261|NCT00385671|3210955|Superiority or Other|||||||0.48||||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.|
1747262|NCT00385671|3210955|Superiority or Other|||||||0.722||||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.|
1747263|NCT00385671|3210955|Superiority or Other|||||||0.72||||||P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.|
1747264|NCT00385671|3210955|Superiority or Other|||||||0.693||||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS.|
1747265|NCT00385671|3210955|Superiority or Other|||||||0.734||||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.|
1747266|NCT00385671|3210955|Superiority or Other|||||||0.954||||||P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.|
1747267|NCT00385671|3210955|Superiority or Other|||||||0.699||||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.|
1747268|NCT00385671|3210955|Superiority or Other|||||||0.345||||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 weeks in LSEQ GTS scores.|
1747269|NCT00385671|3210955|Superiority or Other|||||||0.572||||||P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.|
1747270|NCT00385671|3210956|Superiority or Other|||||||0.2||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.|
1747271|NCT00385671|3210956|Superiority or Other|||||||0.368||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.|
1747356|NCT00384930|3211103|Superiority or Other||||||<|0.001||||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel||||
1747626|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.2||0.5521||95.0|-0.51|0.28|||ANCOVA|||Evoke Pain Cycle 5|
1747272|NCT00385671|3210956|Superiority or Other|||||||0.905||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.|
1747273|NCT00385671|3210957|Superiority or Other|||||||1||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.|
1747274|NCT00385671|3210957|Superiority or Other|||||||0.599||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.|
1747275|NCT00385671|3210957|Superiority or Other|||||||0.548||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of patients with a reduction of ≥ 50% in Weekly mean of 24 hour average pain score.|
1747276|NCT00385671|3210958|Superiority or Other|||||||0.28||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.|
1747277|NCT00385671|3210958|Superiority or Other|||||||0.448||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.|
1747278|NCT00385671|3210958|Superiority or Other|||||||0.975||||||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|Mantel Haenszel|Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with ≥ 30% reduction in the weekly mean 24 hour average pain score at 12 weeks.|
1747279|NCT00385671|3210959|Superiority or Other||Mean Difference (Final Values)|0.1||||0.717|2-Sided|95.0|-0.45|0.65||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.|
1747280|NCT00385671|3210959|Superiority or Other||Mean Difference (Final Values)|0.38||||0.174|2-Sided|95.0|-0.17|0.93||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.|
1747281|NCT00385671|3210959|Superiority or Other||Mean Difference (Final Values)|0.28||||0.309|2-Sided|95.0|-0.26|0.82||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI mean interference score.|
1747282|NCT00385671|3210960|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.452|2-Sided|95.0|-0.86|0.39||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.|
1747283|NCT00385671|3210960|Superiority or Other||Mean Difference (Final Values)|0.28||||0.383|2-Sided|95.0|-0.35|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.|
1747357|NCT00384930|3211103|Superiority or Other||||||<|0.003||||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel||||
1747284|NCT00385671|3210960|Superiority or Other||Mean Difference (Final Values)|0.52||||0.098|2-Sided|95.0|-0.1|1.13||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with enjoyment of life.|
1747285|NCT00385671|3210961|Superiority or Other||Mean Difference (Final Values)|-0.38||||0.27|2-Sided|95.0|-1.06|0.3||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.|
1747286|NCT00385671|3210961|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.626|2-Sided|95.0|-0.84|0.51||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.|
1747287|NCT00385671|3210961|Superiority or Other||Mean Difference (Final Values)|0.21||||0.528|2-Sided|95.0|-0.45|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with sleep.|
1747288|NCT00385671|3210962|Superiority or Other||Mean Difference (Final Values)|0.1||||0.731|2-Sided|95.0|-0.47|0.67||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.|
1747289|NCT00385671|3210962|Superiority or Other||Mean Difference (Final Values)|0.3||||0.301|2-Sided|95.0|-0.27|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with relations with other people.|
1747290|NCT00385671|3210962|Superiority or Other||Mean Difference (Final Values)|0.2||||0.479|2-Sided|95.0|-0.36|0.76||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with relations with other people.|
1747291|NCT00385671|3210963|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.969|2-Sided|95.0|-0.68|0.65||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.|
1747292|NCT00385671|3210963|Superiority or Other||Mean Difference (Final Values)|0.24||||0.485|2-Sided|95.0|-0.43|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with normal work.|
1747293|NCT00385671|3210963|Superiority or Other||Mean Difference (Final Values)|0.25||||0.451|2-Sided|95.0|-0.4|0.9||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly BPI-interference with normal work.|
1747294|NCT00385671|3210964|Superiority or Other||Mean Difference (Final Values)|0.47||||0.173|2-Sided|95.0|-0.21|1.15||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.|
1747295|NCT00385671|3210964|Superiority or Other||Mean Difference (Final Values)|0.68||||0.051|2-Sided|95.0|0.0|1.36||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.|
1747296|NCT00385671|3210964|Superiority or Other||Mean Difference (Final Values)|0.21||||0.541|2-Sided|95.0|-0.46|0.87||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with walking ability.|
1747297|NCT00385671|3210965|Superiority or Other||Mean Difference (Final Values)|0.42||||0.162|2-Sided|95.0|-0.17|1.02||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.|
1747298|NCT00385671|3210965|Superiority or Other||Mean Difference (Final Values)|0.39||||0.195|2-Sided|95.0|-0.2|0.99||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.|
1747299|NCT00385671|3210965|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.922|2-Sided|95.0|-0.61|0.55||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with mood.|
1747300|NCT00385671|3210966|Superiority or Other||Mean Difference (Final Values)|0.52||||0.102|2-Sided|95.0|-0.1|1.13||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.|
1747301|NCT00385671|3210966|Superiority or Other||Mean Difference (Final Values)|0.86||||0.007|2-Sided|95.0|0.24|1.49||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.|
1747302|NCT00385671|3210966|Superiority or Other||Mean Difference (Final Values)|0.35||||0.263|2-Sided|95.0|-0.26|0.95||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-interference with general activity.|
1747303|NCT00385671|3210967|Superiority or Other||Mean Difference (Final Values)|0.05||||0.865|2-Sided|95.0|-0.52|0.62||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.|
1747304|NCT00385671|3210967|Superiority or Other||Mean Difference (Final Values)|0.46||||0.112|2-Sided|95.0|-0.11|1.03||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.|
1747305|NCT00385671|3210967|Superiority or Other||Mean Difference (Final Values)|0.41||||0.145|2-Sided|95.0|-0.14|0.97||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: pain right now.|
1747306|NCT00385671|3210968|Superiority or Other||Mean Difference (Final Values)|0.0||||0.989|2-Sided|95.0|-0.53|0.54||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: least pain.|
1747307|NCT00385671|3210968|Superiority or Other||Mean Difference (Final Values)|0.28||||0.304|2-Sided|95.0|-0.25|0.81||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.|
1747308|NCT00385671|3210968|Superiority or Other||Mean Difference (Final Values)|0.28||||0.298|2-Sided|95.0|-0.25|0.8||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Least Pain.|
1747309|NCT00385671|3210969|Superiority or Other||Mean Difference (Final Values)|0.39||||0.244|2-Sided|95.0|-0.27|1.04||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: Worst Pain.|
1747310|NCT00385671|3210969|Superiority or Other||Mean Difference (Final Values)|0.69||||0.039|2-Sided|95.0|0.03|1.34||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.|
1747311|NCT00385671|3210969|Superiority or Other||Mean Difference (Final Values)|0.3||||0.353|2-Sided|95.0|-0.34|0.94||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-severity: worst pain.|
1747312|NCT00385671|3210970|Superiority or Other||Mean Difference (Final Values)|0.15||||0.602|2-Sided|95.0|-0.41|0.7||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.|
1747313|NCT00385671|3210970|Superiority or Other||Mean Difference (Final Values)|0.64||||0.025|2-Sided|95.0|0.08|1.2||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.|
1747314|NCT00385671|3210970|Superiority or Other||Mean Difference (Final Values)|0.49||||0.078|2-Sided|95.0|-0.06|1.04||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BPI-Severity: 24-hour average pain.|
1747315|NCT00385671|3210971|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.313|2-Sided|95.0|-0.53|0.17||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in PGI-Improvement at 12 weeks.|
1747316|NCT00385671|3210971|Superiority or Other||Mean Difference (Final Values)|0.02||||0.929|2-Sided|95.0|-0.33|0.37||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in PGI-Improvement at 12 weeks.|
1747317|NCT00385671|3210971|Superiority or Other||Mean Difference (Final Values)|0.2||||0.276|2-Sided|95.0|-0.16|0.55||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Variance model and t-tests:~Endpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented."||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in PGI-Improvement at 12 weeks.|
1747318|NCT00385671|3210972|Superiority or Other||Mean Difference (Final Values)|0.03||||0.841|2-Sided|95.0|-0.24|0.3||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.|
1747319|NCT00385671|3210972|Superiority or Other||Mean Difference (Final Values)|0.1||||0.469|2-Sided|95.0|-0.17|0.37||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|"Analysis of Covariance model and t-tests:~Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used."||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in CGI severity.|
1747393|NCT00384189|3211168|Superiority or Other||Least Squares Means Difference|12.0|Standard Error of the Mean|4.3||0.0028|2-Sided|95.0|3.5|20.4|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.|||
1747320|NCT00385671|3210972|Superiority or Other||Mean Difference (Final Values)|0.07||||0.602|2-Sided|95.0|-0.2|0.35||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.|t-test, 2 sided|Analysis of Covariance model and t-tests: Change=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.|
1747321|NCT00385671|3210973|Superiority or Other|||||||0.489||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.|
1747322|NCT00385671|3210973|Superiority or Other|||||||0.126||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.|
1747323|NCT00385671|3210973|Superiority or Other|||||||0.389||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in weekly mean of the daily worst pain severity score.|
1747324|NCT00385671|3210974|Superiority or Other|||||||0.463||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.|
1747325|NCT00385671|3210974|Superiority or Other|||||||0.52||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.|
1747326|NCT00385671|3210974|Superiority or Other|||||||0.463||||||P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week; denominator degrees of freedom, Kenward-Rogers approximation||Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.|
1747327|NCT00385671|3210975|Non-Inferiority or Equivalence|Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.|Mean Difference (Final Values)|0.23||||0.417|2-Sided|95.0|-0.32|0.78||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week, Kenward-Roger approximation was used.||Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between duloxetine & duloxetine+gabapentin treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.|
1747328|NCT00385671|3210976|Non-Inferiority or Equivalence|Basis of non-inferiority margin (maximum disadvantage for duloxetine compared to pregabalin not considered meaningful): In 3 previous placebo-controlled trials of duloxetine in DPNP, in the subgroup of patients that had been treated with gabapentin prior to entry, the estimated mean change in pain at Week 12 was -2.74 for duloxetine and -1.09 for placebo, an advantage of about 1.65. The non-inferiority margin represents about half of this previous treatment effect in a similar population.|Mean Difference (Final Values)|0.49||||0.076|2-Sided|95.0|-0.05|1.04||P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.|Mixed Models Analysis|Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment*Week+Baseline*Week, Kenward-Roger approximation was used.||Null hypothesis: no difference in mean change from baseline to 12 weeks in weekly mean of daily 24 hour average pain score between pregabalin & duloxetine treatments. Sample size: 125 participants/treatment, 6% increase for 400 planned enrollees. 92% power with 1-sided 97.5% confidence interval; mean change in duloxetine group, -2.7; in pregabalin group, -2.5; standard deviation, 2.3; margin of non-inferiority: -0.8.|
1747329|NCT00385268|3211030|Superiority|||||||0.99|||||||Wilcoxon (Mann-Whitney)||||
1747330|NCT00385268|3211031|Superiority||Odds Ratio (OR)|1.68||||0.44|2-Sided|95.0|0.55|5.14|||GEE model of repeated measures|GEE on repeated binary indicators of BE positive / negative test|||
1747358|NCT00384930|3211103|Superiority or Other||||||<|0.133||||||P-values are from Cochran-Mantel-Haenszel test stratified by the randomization strata factors (4 geographic regions, 2 levels of IPSS severity, 2 levels of ED history) as fixed effect, and were not adjusted for multiple comparisons.|Cochran-Mantel-Haenszel||||
1747866|NCT00378898|3211971|Superiority|||||||0.047|||||||t-test, 2 sided||||
1747331|NCT00385255|3211042|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase anti-B antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|2.15|||||2-Sided|95.0|-2.9|7.2||||||Difference in seroconversion rates for anti-B antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-B antibody, one month post-Fluarix® vaccination.|
1747332|NCT00385255|3211042|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase in anti-H3N2 antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|5.58|||||2-Sided|95.0|1.1|10.07||||||Difference in seroconversion rates for anti-H3N2 antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H3N2 antibody, one month post-Fluarix® vaccination.|
1747333|NCT00385255|3211042|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with ≥ 4-fold increase in anti-H1N1 antibody titers (seroconversion) being ≥ -10%.|Difference in seroconversion rate|2.37|||||2-Sided|95.0|-2.84|7.58||||||Difference in seroconversion rates for anti-H1N1 antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of seroconversion rates for anti-H1N1 antibody, one month post-Fluarix® vaccination.|
1747334|NCT00385255|3211043|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-B antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-0.55|||||2-Sided|95.0|-2.52|1.42||||||Difference in percentage of subjects with anti-B antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-B antibody titers ≥ 1:40, one month post-Fluarix® vaccination.|
1747335|NCT00385255|3211043|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H3N2 antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-0.61|||||2-Sided|95.0|-2.22|0.96||||||Difference in percentage of subjects with anti-H3N2 antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H3N2 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.|
1747336|NCT00385255|3211043|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H1N1 antibody titers ≥ 1:40 being ≥ -10%.|Difference in percentage|-1.17|||||2-Sided|95.0|-3.58|1.23||||||Difference in percentage of subjects with anti-H1N1 antibody titers ≥ 1:40: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Fluarix® vaccine administered alone at Day 0 (Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-H1N1 antibody titers ≥ 1:40, one month post-Fluarix® vaccination.|
1747337|NCT00385255|3211044|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the pertactin (PRN) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.7|||||2-Sided|95.0|0.6|0.81||||||Difference in adjusted GMC ratio for anti-PRN antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-PRN antibody, one month post-Boostrix® vaccination.|
1747338|NCT00385255|3211044|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the filamentous hemagglutinin (FHA) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.71|||||2-Sided|95.0|0.64|0.79||||||Difference in adjusted GMC ratio for anti-FHA antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-FHA antibody, one month post-Boostrix® vaccination.|
1747339|NCT00385255|3211044|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for GMC ratios of antibodies against the pertussis toxoid (PT) antigens between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group) being ≥ 0.67.|Adjusted GMC ratio|0.74|||||2-Sided|95.0|0.67|0.82||||||Difference in adjusted GMC ratios for anti-PT antibody: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of geometric mean concentrations (GMCs) for anti-PT antibody, one month post-Boostrix® vaccination.|
1747359|NCT00384930|3211104|Superiority or Other||Mean Difference (Net)|-0.62||||0.007||95.0|-1.08|-0.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo||
1747340|NCT00385255|3211045|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-T antibody concentrations ≥ 1.0 IU/mL, being ≥ - 10%.|Difference in percentage|1.4|||||2-Sided|95.0|-0.77|3.68||||||Difference in seropositivity rates against tetanus toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seropositivity rates for anti-T antibody, one month post-Boostrix® vaccination.|
1747341|NCT00385255|3211046|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two groups (Boostrix+ Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentage of subjects with anti-T antibody concentrations ≥ 0.1 IU/mL, being ≥ - 10%.|Difference in percentage|-1.67|||||2-Sided|95.0|-2.96|-0.74||||||Difference in seroprotection rates against tetanus toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seroprotection rates for anti-T antibody, one month post-Boostrix® vaccination.|
1747342|NCT00385255|3211046|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) for the difference between the two groups (Boostrix+Fluarix 19-64 YOA Group minus Fluarix Boostrix 19-64 YOA Group), in terms of percentages of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL, being ≥ - 10%.|Difference in percentage|1.06|||||2-Sided|95.0|-1.36|3.56||||||Difference in seroprotection rates against diphteria toxoid: To demonstrate that the immunogenicity of Boostrix® vaccine co-administered with Fluarix® vaccine (Boostrix+Fluarix 19-64 YOA Group) at Day 0, was non-inferior to that of Boostrix® vaccine administered alone at Month 1 (Fluarix Boostrix 19-64 YOA Group), in terms of seroprotection rates for anti-D antibody, one month post-Boostrix® vaccination.|
1747343|NCT00384930|3211100|Superiority or Other||Mean Difference (Net)|-2.94|||<|0.001||95.0|-4.04|-1.84||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.|
1747344|NCT00384930|3211100|Superiority or Other||Mean Difference (Net)|-2.9|||<|0.001||95.0|-3.99|-1.81||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.|
1747345|NCT00384930|3211100|Superiority or Other||Mean Difference (Net)|-2.6|||<|0.001||95.0|-3.69|-1.51||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.|
1747346|NCT00384930|3211100|Superiority or Other||Mean Difference (Net)|-1.58|||<|0.005||95.0|-2.68|-0.48||P-values are from an ANCOVA model with effect of treatment group, geographic region, and IPSS baseline value (at Visit 3) as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo|This is a supportive analysis of the primary outcome.|
1747347|NCT00384930|3211101|Superiority or Other||Mean Difference (Net)|6.15|||<|0.001||95.0|4.35|7.95||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo||
1747348|NCT00384930|3211101|Superiority or Other||Mean Difference (Net)|5.83|||<|0.001||95.0|4.04|7.62||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo||
1747349|NCT00384930|3211101|Superiority or Other||Mean Difference (Net)|4.75|||<|0.001||95.0|2.95|6.54||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo||
1747350|NCT00384930|3211101|Superiority or Other||Mean Difference (Net)|3.36|||<|0.001||95.0|1.56|5.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo||
1747351|NCT00384930|3211102|Superiority or Other||Mean Difference (Net)|0.74||||0.089||95.0|-0.11|1.59||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo||
1747352|NCT00384930|3211102|Superiority or Other||Mean Difference (Net)|0.34||||0.433||95.0|-0.5|1.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo||
1747353|NCT00384930|3211102|Superiority or Other||Mean Difference (Net)|0.39||||0.355||95.0|-0.44|1.23||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo||
1747354|NCT00384930|3211102|Superiority or Other||Mean Difference (Net)|0.14||||0.735||95.0|-0.69|0.98||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo||
1747733|NCT00380588|3211691|Superiority or Other|||||||0.38||||||P-value for response (Complete Response + Partial Response).|Fisher Exact||||
1747362|NCT00384930|3211104|Superiority or Other||Mean Difference (Net)|-0.13||||0.583||95.0|-0.58|0.33||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo||
1747363|NCT00384930|3211105|Superiority or Other||Mean Difference (Net)|-0.4|||<|0.001||95.0|-0.64|-0.17||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo||
1747364|NCT00384930|3211105|Superiority or Other||Mean Difference (Net)|-0.43|||<|0.001||95.0|-0.66|-0.19||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo||
1747365|NCT00384930|3211105|Superiority or Other||Mean Difference (Net)|-0.37|||<|0.002||95.0|-0.6|-0.14||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo||
1747366|NCT00384930|3211105|Superiority or Other||Mean Difference (Net)|-0.26|||<|0.029||95.0|-0.49|-0.03||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo||
1747367|NCT00384930|3211106|Superiority or Other||Mean Difference (Net)|-0.26||||0.012||95.0|-0.47|-0.06||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo||
1747368|NCT00384930|3211106|Superiority or Other||Mean Difference (Net)|-0.08||||0.452||95.0|-0.28|0.13||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo||
1747369|NCT00384930|3211106|Superiority or Other||Mean Difference (Net)|-0.13||||0.206||95.0|-0.34|0.07||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo||
1747370|NCT00384930|3211106|Superiority or Other||Mean Difference (Net)|-0.07||||0.503||95.0|-0.28|0.14||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo||
1747371|NCT00384930|3211107|Superiority or Other||Mean Difference (Net)|-1.87|||<|0.001||95.0|-2.59|-1.15||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo||
1747372|NCT00384930|3211107|Superiority or Other||Mean Difference (Net)|-1.89|||<|0.001||95.0|-2.6|-1.18||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo||
1747373|NCT00384930|3211107|Superiority or Other||Mean Difference (Net)|-1.69|||<|0.001||95.0|-2.4|-0.98||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo||
1747374|NCT00384930|3211107|Superiority or Other||Mean Difference (Net)|-0.97|||<|0.008||95.0|-1.69|-0.26||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo||
1747375|NCT00384930|3211108|Superiority or Other||Mean Difference (Net)|-1.07|||<|0.001||95.0|-1.58|-0.57||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 20 mg Tadalafil minus Placebo||
1747376|NCT00384930|3211108|Superiority or Other||Mean Difference (Net)|-0.96|||<|0.001||95.0|-1.45|-0.46||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 10 mg Tadalafil minus Placebo||
1747377|NCT00384930|3211108|Superiority or Other||Mean Difference (Net)|-0.9|||<|0.001||95.0|-1.4|-0.4||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 5 mg Tadalafil minus Placebo||
1747378|NCT00384930|3211108|Superiority or Other||Mean Difference (Net)|-0.57|||<|0.025||95.0|-1.08|-0.07||P-value for Change from Baseline. Change=Endpoint - Baseline. P-values from ANCOVA model with effect of treatment group, geographic region, and baseline value of analyzed variable as a covariate, and were not adjusted for multiple comparisons.|ANCOVA||Mean Difference = 2.5 mg Tadalafil minus Placebo||
1747379|NCT00384930|3211109|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline. Change = Endpoint minus Baseline.|Permutation Test|||This is the principal inferential analysis of the primary outcome.|
1747394|NCT00384189|3211168|Superiority or Other||Least Square Means Difference|9.4|Standard Error of the Mean|4.3||0.0148|2-Sided|95.0|0.9|17.8|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.|||
1747395|NCT00384189|3211168|Superiority or Other||Least Squares Mean Difference|9.8|Standard Error of the Mean|4.3||0.0116|2-Sided|95.0|1.4|18.3|||ANCOVA|Baseline value and age as covariates. One-sided p-value, significance level 2.5%.|||
1747396|NCT00384085|3211177|Superiority or Other||Adjusted Odds Ratio|2.06||||0.0121|2-Sided|95.0|1.17|3.61|||Regression, Logistic||||
1747397|NCT00384085|3211177|Superiority or Other||Adjusted Odds Ratio|2.11||||0.0107|2-Sided|95.0|1.19|3.73|||Regression, Logistic||||
1747398|NCT00384085|3211177|Superiority or Other||Adjusted Odds Ratio|1.02||||0.9268|2-Sided|95.0|0.61|1.71|||Regression, Logistic||||
1747399|NCT00384085|3211178|Superiority or Other||Adjusted Odds Ratio|1.79||||0.014|2-Sided|95.0|1.12|2.85|||Regression, Logistic||||
1747400|NCT00384085|3211179|Superiority or Other||Adjusted Mean of difference|-0.31||||0.0565|2-Sided|95.0|-0.63|0.01|||ANCOVA||||
1747401|NCT00384085|3211180|Superiority or Other||Adjusted Odds Ratio|1.66||||0.0313|2-Sided|95.0|1.04|2.64||The type I error was controlled by performing a 2-tailed comparison at a p=0.0475 level for superiority testing.|Regression, Logistic||||
1747402|NCT00384085|3211181|Non-Inferiority or Equivalence|Noninferiority of Lantus/Apidra-1 would be established if the upper limit of the 2 sided, 99.75% CI for the difference in the mean change from baseline between Lantus/Apidra-1 and Novolog Mix 70/30 was <0.5%.|Adjusted Mean of difference|-0.34||||0.0359|2-Sided|95.0|-0.82|0.15||The type I error was controlled by performing a 2-tailed comparison at a p=0.0025 level for noninferiority testing.|Mixed Models Analysis||||
1747403|NCT00384085|3211182|Superiority or Other||Adjusted Odds Ratio|1.56||||0.0628|2-Sided|95.0|0.97|2.52||The type I error was controlled by performing a 2-tailed comparison at a p=0.0475 level for superiority testing.|Regression, Logistic||||
1747404|NCT00384059|3211183|Superiority or Other||Ration|0.85||||||95.0|0.48|1.49||||||For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated|
1747405|NCT00384059|3211188|Superiority or Other||Ratio|1.13||||||95.0|0.83|1.53||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated|
1747406|NCT00384059|3211189|Non-Inferiority or Equivalence|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.81|1.23||||||For Pertussis FIM the GMC ratio (13vPnC/7vPnC) was calculated|
1747407|NCT00384059|3211189|Non-Inferiority or Equivalence|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.8|1.26||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated|
1747408|NCT00384059|3211189|Non-Inferiority or Equivalence|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.83|1.17||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated|
1747409|NCT00384059|3211189|Non-Inferiority or Equivalence|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.82|1.16||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated|
1747410|NCT00384059|3211190|Non-Inferiority or Equivalence|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.77||||||95.0|0.54|1.08||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated|
1747411|NCT00384059|3211191|Non-Inferiority or Equivalence|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.89||||||95.0|0.68|1.16||||||For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated|
1747412|NCT00384059|3211192|Superiority or Other||Difference|-1.0||||||95.0|-5.3|2.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated|
1747413|NCT00384059|3211192|Superiority or Other||Difference|0.0||||||95.0|-3.5|3.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated|
1747414|NCT00384059|3211193|Superiority or Other||Difference|-0.1||||||95.0|-8.0|8.1||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated|
1747415|NCT00384059|3211193|Superiority or Other||Difference|-5.3||||||95.0|-19.7|8.8||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated|
1747416|NCT00384059|3211194|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.|Difference|1.0||||||95.0|-4.1|6.5||||||For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated|
1747417|NCT00384059|3211194|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.|Difference|2.7||||||95.0|-0.5|7.6||||||For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 2.2 EU/mL threshold was calculated|
1747418|NCT00384059|3211194|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.|Difference|-3.1||||||95.0|-10.0|3.4||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 15 EU/mL threshold was calculated|
1747419|NCT00384059|3211194|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated|
1747420|NCT00384059|3211194|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.|Difference|-1.5||||||95.0|-7.9|4.8||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated|
1747623|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.69|Standard Error of the Mean|0.51||0.1845||95.0|-0.34|1.72|||ANCOVA|||Evoke Pain Cycle 8|
1747421|NCT00384059|3211194|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated|
1747422|NCT00384059|3211194|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.|Difference|0.0||||||95.0|-3.2|3.2||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated|
1747423|NCT00384059|3211194|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.|Difference|1.1||||||95.0|-4.5|7.1||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 17 EU/mL threshold was calculated|
1747424|NCT00384059|3211194|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.|Difference|0.0||||||95.0|-3.2|3.3||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated|
1747425|NCT00384059|3211194|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.|Difference|-4.1||||||95.0|-13.4|5.1||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated|
1747426|NCT00384059|3211194|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC – 7vPnC) > -10%.|Difference|-1.5||||||95.0|-7.1|3.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated|
1747427|NCT00384059|3211194|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-3.8|3.9||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated|
1747428|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|3.3||||0.155|2-Sided|95.0|-1.2|7.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.|
1747429|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|4.9||||0.042|2-Sided|95.0|0.2|9.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.|
1747430|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|2.0||||0.412|2-Sided|95.0|-2.8|6.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, arms, legs, joint pain score was evaluated using ANCOVA with treatment and site as factors and baseline arms, legs, pain score as the covariate.|
1747431|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|1.4||||0.411|2-Sided|95.0|-1.9|4.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.|
1747432|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|2.0||||0.221|2-Sided|95.0|-1.2|5.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.|
1747433|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|1.4||||0.384|2-Sided|95.0|-1.7|4.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, chest pain score was evaluated using ANCOVA with treatment and site as factors and baseline chest pain score as the covariate.|
1747434|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|4.2||||0.103|2-Sided|95.0|-0.8|9.2||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.|
1747435|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|5.8||||0.015|2-Sided|95.0|1.1|10.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.|
1747436|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|3.7||||0.122|2-Sided|95.0|-1.0|8.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, back pain score was evaluated using ANCOVA with treatment and site as factors and baseline back pain score as the covariate.|
1747437|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|3.8||||0.088|2-Sided|95.0|-0.5|8.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.|
1747438|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|4.6||||0.048|2-Sided|95.0|0.1|9.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.|
1747624|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.58|Standard Error of the Mean|0.37||0.1214||95.0|-0.16|1.33|||ANCOVA|||Evoke Pain Cycle 7|
1747439|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|3.1||||0.177|2-Sided|95.0|-1.4|7.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, stomach pain score was evaluated using ANCOVA with treatment and site as factors and baseline stomach pain score as the covariate.|
1747440|NCT00384033|3211195|Superiority or Other||Median Difference (Final Values)|4.1||||0.093|2-Sided|95.0|-0.7|8.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.|
1747441|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|4.7||||0.035|2-Sided|95.0|0.3|9.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.|
1747442|NCT00384033|3211195|Superiority or Other||Mean Difference (Final Values)|3.5||||0.124|2-Sided|95.0|-0.9|7.9||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, overall VAS-PI score was evaluated using ANCOVA with treatment and site as factors and baseline VAS-PI score as the covariate.|
1747443|NCT00384033|3211196|Superiority or Other||Median Difference (Final Values)|0.5||||0.006|2-Sided|95.0|0.1|0.9||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.|
1747444|NCT00384033|3211196|Superiority or Other||Mean Difference (Final Values)|0.3||||0.056|2-Sided|95.0|0.0|0.7||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.|
1747445|NCT00384033|3211196|Superiority or Other||Mean Difference (Final Values)|0.1||||0.445|2-Sided|95.0|-0.2|0.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, Covi anxiety scale was evaluated using ANCOVA with treatment and site as factors and baseline Covi anxiety score as the covariate.|
1747446|NCT00384033|3211197|Superiority or Other||Mean Difference (Final Values)|0.72||||0.032|2-Sided|95.0|0.06|1.38||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.|
1747447|NCT00384033|3211197|Superiority or Other||Mean Difference (Final Values)|0.79||||0.014|2-Sided|95.0|0.16|1.42||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.|
1747448|NCT00384033|3211197|Superiority or Other||Mean Difference (Final Values)|0.53||||0.1|2-Sided|95.0|-0.1|1.17||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, HAM-D energy subscale score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D energy score as the covariate.|
1747449|NCT00384033|3211198|Superiority or Other||Mean Difference (Final Values)|1.1||||0.024|2-Sided|95.0|0.2|2.1||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.|
1747450|NCT00384033|3211198|Superiority or Other||Mean Difference (Final Values)|1.3||||0.005|2-Sided|95.0|0.4|2.3||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.|
1747451|NCT00384033|3211198|Superiority or Other||Mean Difference (Final Values)|0.6||||0.215|2-Sided|95.0|-0.3|1.5||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, HAM-D6 score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D6 score as the covariate.|
1747452|NCT00384033|3211199|Superiority or Other||Mean Difference (Final Values)|0.06||||0.71|2-Sided|95.0|-0.27|0.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.|
1747453|NCT00384033|3211199|Superiority or Other||Mean Difference (Final Values)|0.27||||0.119|2-Sided|95.0|-0.07|0.61||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.|
1747454|NCT00384033|3211199|Superiority or Other||Mean Difference (Final Values)|0.12||||0.473|2-Sided|95.0|-0.22|0.46||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, lassitude item of the MADRS score was evaluated using ANCOVA with treatment and site as factors and baseline lassitude item of the MADRS score as the covariate.|
1747455|NCT00384033|3211200|Superiority or Other||Mean Difference (Final Values)|3.4||||0.005|2-Sided|95.0|1.1|5.8||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.|
1747456|NCT00384033|3211200|Superiority or Other||Mean Difference (Final Values)|3.3||||0.004|2-Sided|95.0|1.1|5.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.|
1747457|NCT00384033|3211200|Superiority or Other||Mean Difference (Final Values)|1.7||||0.149|2-Sided|95.0|-0.6|4.0||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, MADRS total score was evaluated using ANCOVA with treatment and site as factors and baseline MADRS score as the covariate.|
1747458|NCT00384033|3211201|Superiority or Other||Median Difference (Final Values)|0.3||||0.026|2-Sided|95.0|0.0|0.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.|
1747459|NCT00384033|3211201|Superiority or Other||Mean Difference (Final Values)|0.3||||0.011|2-Sided|95.0|0.1|0.6||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 100 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.|
1747460|NCT00384033|3211201|Superiority or Other||Mean Difference (Final Values)|0.2||||0.248|2-Sided|95.0|-0.1|0.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For DVS SR 50 mg, CGI-S was evaluated using ANCOVA with treatment and site as factors and baseline CGI-S score as the covariate.|
1747461|NCT00384033|3211202|Superiority or Other|||||||0.008||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For Duloxetine 60 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.|
1747462|NCT00384033|3211202|Superiority or Other|||||||0.009||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For DVS SR 100 mg, CGI-I was evaluated using CMH test with treatment as a factor and controlling for center.|
1747463|NCT00384033|3211202|Superiority or Other|||||||0.11||||||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|Cochran-Mantel-Haenszel|||For DVS SR 50 mg, CGI-I was evaluated using Cochran-Mantel-Haenszel (CMH) test with treatment as a factor and controlling for center.|
1747464|NCT00384033|3211203|Superiority or Other||Mean Difference (Final Values)|1.7||||0.047|2-Sided|95.0|0.0|3.4||The analysis was done at a significance level of alpha = 0.05, 2-sided, without any adjustments for multiple comparisons.|ANCOVA|||For Duloxetine 60 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.|
1747465|NCT00384033|3211203|Superiority or Other||Mean Difference (Final Values)|1.8||||0.028|2-Sided|95.0|0.2|3.4||The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.|ANCOVA|||For DVS SR 100 mg, HAM-D17 total score was evaluated using ANCOVA with treatment and site as factors and baseline HAM-D17 score as the covariate.|
1747466|NCT00384033|3211203|Superiority or Other||Mean Difference (Final Values)|1.1||||0.198|2-Sided|95.0|-0.6|2.7||The analysis was done at a significance level of alpha = 0.05, 2-sided. Global F-test was used to adjust for multiplicity. If global F-test was significant at 0.05 level, pair wise analysis was interpreted without any further p-value adjustment.|ANCOVA|||For DVS SR 50 mg, HAM-D17 total score was evaluated using analysis of covariance (ANCOVA) with treatment and site as factors and baseline HAM-D17 score as the covariate.|
1747467|NCT00383721|3211225|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1747468|NCT00383721|3211225|Superiority or Other||||||<|0.02|||||||ANCOVA||||
1747469|NCT00383721|3211226|Superiority or Other|||||||0.583|||||||ANCOVA||||
1747470|NCT00383721|3211226|Superiority or Other|||||||0.062|||||||ANCOVA||||
1747471|NCT00383721|3211227|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1747472|NCT00383721|3211227|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1747473|NCT00383708|3211254|Other||||||<|0.0001||||||One-sided p-value|Exact test|||The percentage of subjects in the subgroup 'at any time during co-administration' (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor > 0.3.|
1747474|NCT00383708|3211254|Other||||||<|0.0001||||||One-sided p-value|Exact test|||The percentage of subjects in the subgroup 'while taking final dose during co-administration' (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor > 0.3.|
1747475|NCT00383708|3211255|Other||||||<|0.0001||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup non diabetic subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor > 0.3.|
1747476|NCT00383708|3211255|Other||||||<|0.084||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup diabetic subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor > 0.3.|
1747477|NCT00383708|3211256|Other|||||||0.0003||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with octreotide LAR (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor > 0.3.|
1747478|NCT00383708|3211256|Other|||||||0.0115||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with lanreotide Autogel (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor > 0.3.|
1747479|NCT00383708|3211256|Other|||||||0.1654||||||One-sided p value|Exact test|||The percentage of subjects in the subgroup previously treated with pegvisomant (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor > 0.3.|
1747480|NCT00383708|3211257|Other||||||<|0.0001|||||||Exact test|One-sided p value||The percentage of subjects (denoted as pnor) was compared to the minimum clinically relevant (theoretical) percentage of 30%, using an exact test based on the binomial distribution. The test was an upper-tailed test of H0: pnor ≤ 0.3 versus H1: pnor > 0.3.|
1747481|NCT00383552|3211270|Superiority or Other||||||<|0.001||||||BMI less than 25 and for BMI 30 or more|ANCOVA||||
1747482|NCT00383552|3211270|Superiority or Other||||||<|0.015||||||BMI 25 to <30|ANCOVA||||
1747483|NCT00383552|3211271|Superiority or Other|||||||0.073|||||||Longitudinal Model||||
1747484|NCT00383552|3211272|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1747485|NCT00383552|3211273|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1747486|NCT00383552|3211275|Superiority or Other|||||||0.001|||||||ANCOVA||||
1747487|NCT00383552|3211276|Superiority or Other|||||||0.001|||||||ANCOVA||||
1747488|NCT00383435|3211287|Superiority or Other|||||||0.059|||||||ANCOVA||||
1747489|NCT00383435|3211287|Superiority or Other|||||||0.002|||||||ANCOVA||||
1747490|NCT00383435|3211288|Superiority or Other|||||||0.029|||||||ANCOVA||||
1747491|NCT00383435|3211288|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1747492|NCT00383435|3211289|Superiority or Other|||||||0.007|||||||ANCOVA||||
1747493|NCT00383435|3211289|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1747494|NCT00383331|3211290|Superiority or Other|||||||0.56|||||||Log Rank||||
1747495|NCT00383331|3211295|Superiority or Other|||||||0.48|||||||Fisher Exact|||The response rates are separately evaluated for these two treatment arms. For each arm, a sample size of 48 achieves 91% power to detect a difference of 20% between the null hypothesis of 15% response rate and the alternative hypothesis of 35% using a one-sided, binomial hypothesis test with a target significance level of 2.5% (the actual significance level is 2.2%).|
1747496|NCT00383240|3211312|Superiority or Other|||||||0.601||||||P-Value for Endpoint|ANCOVA||||
1747497|NCT00383240|3211312|Superiority or Other|||||||0.003||||||P-Value for Endpoint|ANCOVA||||
1747498|NCT00383240|3211312|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747499|NCT00383240|3211312|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747500|NCT00383240|3211312|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747501|NCT00383240|3211312|Superiority or Other||||||<|0.063||||||P-Value for endpoint|ANCOVA||||
1747502|NCT00383240|3211313|Superiority or Other|||||||0.738||||||P-Value for Endpoint|ANCOVA||||
1747503|NCT00383240|3211313|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747504|NCT00383240|3211313|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747505|NCT00383240|3211313|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747506|NCT00383240|3211313|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747507|NCT00383240|3211313|Superiority or Other||||||<|0.026||||||P-Value for Endpoint|ANCOVA||||
1747508|NCT00383240|3211315|Superiority or Other|||||||0.521||||||P-Value for Endpoint|ANCOVA||||
1747509|NCT00383240|3211315|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747510|NCT00383240|3211315|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747511|NCT00383240|3211315|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747512|NCT00383240|3211315|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747513|NCT00383240|3211315|Superiority or Other||||||<|0.174||||||P-Value for Endpoint|ANCOVA||||
1747514|NCT00383240|3211316|Superiority or Other|||||||0.008||||||P-Value for Endpoint|ANCOVA||||
1747515|NCT00383240|3211316|Superiority or Other|||||||0.055||||||P-Value for Endpoint|ANCOVA||||
1747516|NCT00383240|3211316|Superiority or Other|||||||0.491||||||P-Value for Endpoint|ANCOVA||||
1747517|NCT00383240|3211316|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747518|NCT00383240|3211316|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747519|NCT00383240|3211316|Superiority or Other||||||<|0.001||||||P-Value for Endpoint|ANCOVA||||
1747520|NCT00383162|3211335|Superiority or Other||Odds Ratio (OR)|4.5|||<|0.001||95.0|2.17|9.36|||Generalized Estimating Equations||||
1747521|NCT00383110|3211357|Superiority or Other||||||<|0.001|||||||ANOVA||||
1747522|NCT00383110|3211358|Superiority or Other||||||<|0.001|||||||ANOVA||||
1747523|NCT00383110|3211359|Superiority or Other|||||||0.03|||||||ANOVA||||
1747524|NCT00383110|3211360|Superiority or Other|||||||0.675|||||||ANOVA||||
1747525|NCT00383110|3211361|Superiority or Other|||||||0.14|||||||ANOVA||||
1747526|NCT00383110|3211362|Superiority or Other|||||||0.648|||||||ANOVA||||
1747527|NCT00383019|3211368|Superiority or Other|||||||0.001||||||The level of statistical significance was the two-sided 0.05. Primary as well as secondary endpoints were tested, but because the tests of the secondary endpoints are exploratory, no adjustment to p-values was made for multiple comparisons.|Regression, Logistic|The comparison between the treatment groups was performed by using a logistic regression model which incorporated the baseline IOP.|||
1747528|NCT00383019|3211369|Superiority or Other||||||<|0.001||||||The level of statistical significance was the two-sided 0.05. Primary as well as secondary endpoints were tested, but because the tests of the secondary endpoints are exploratory, no adjustment to p-values was made for multiple comparisons.|Regression, Logistic|The comparison between the treatment groups was performed by using a logistic regression model which incorporated the baseline IOP.|||
1747529|NCT00383019|3211370|Superiority or Other|||||||0.015||||||The level of statistical significance was the two-sided 0.05. Primary as well as secondary endpoints were tested, but because the tests of the secondary endpoints are exploratory, no adjustment to p-values was made for multiple comparisons.|Regression, Logistic|The comparison between the treatment groups was performed by using a logistic regression model which incorporated the baseline IOP.|||
1747775|NCT00380081|3211749|Superiority or Other|||||||0.79||||||Treatment effect|ANCOVA||||
1747530|NCT00383019|3211371|Superiority or Other|||||||0.001||||||The level of statistical significance was the two-sided 0.05. Primary as well as secondary endpoints were tested, but because the tests of the secondary endpoints are exploratory, no adjustment to p-values was made for multiple comparisons.|Regression, Logistic|The comparison between the treatment groups was performed by using a logistic regression model which incorporated the baseline IOP.|||
1747531|NCT00383019|3211372|Superiority or Other|||||||0.001||||||The level of statistical significance was the two-sided 0.05. Primary as well as secondary endpoints were tested, but because the tests of the secondary endpoints are exploratory, no adjustment to p-values was made for multiple comparisons.|Regression, Logistic|The comparison between the treatment groups was performed by using a logistic regression model which incorporated the baseline IOP.|||
1747532|NCT00383019|3211373|Superiority or Other||||||<|0.001||||||The level of statistical significance was the two-sided 0.05. Primary as well as secondary endpoints were tested, but because the tests of the secondary endpoints are exploratory, no adjustment to p-values was made for multiple comparisons.|Regression, Logistic|The comparison between the treatment groups was performed by using a logistic regression model which incorporated the baseline IOP.|||
1747533|NCT00383019|3211374|Superiority or Other||Mean Difference (Final Values)|-4.98|||<|0.001||95.0|-7.43|-2.52||The level of statistical significance was the two-sided 0.05. Primary as well as secondary endpoints were tested, but because the tests of the secondary endpoints are exploratory, no adjustment to p-values was made for multiple comparisons.|ANCOVA|The analysis of covariance (ANCOVA) was applied using the treatment groups as a factor and baseline IOP of the study eyes as a covariate.|"Mean difference was calculated as percent change from baseline to Week 8 in KP2035 group minus percent change from baseline to Week 8 in Xalatan group."||
1747534|NCT00383019|3211375|Superiority or Other||Mean Difference (Final Values)|-1.34|||<|0.001||95.0|-1.8|-0.87||The level of statistical significance was the two-sided 0.05. Primary as well as secondary endpoints were tested, but because the tests of the secondary endpoints are exploratory, no adjustment to p-values was made for multiple comparisons.|ANCOVA|The analysis of covariance (ANCOVA) was applied using the treatment groups as a factor and baseline IOP of the study eyes as a covariate.|"Mean difference was calculated as mean change from baseline to Week 4 in KP2035 group minus mean change from baseline to Week 4 in Xalatan group."||
1747535|NCT00383019|3211376|Superiority or Other||Mean Difference (Final Values)|-0.97|||<|0.001||95.0|-1.44|-0.49||The level of statistical significance was the two-sided 0.05. Primary as well as secondary endpoints were tested, but because the tests of the secondary endpoints are exploratory, no adjustment to p-values was made for multiple comparisons.|ANCOVA|Analysis of covariance (ANCOVA) was applied using the treatment groups as a factor and baseline IOP of the study eyes as a covariate.|"Mean difference was calculated as mean change from baseline to Week 8 in KP2035 group minus mean change from baseline to Week 8 in Xalatan group."|The sample size of 132 subjects per group would be needed to detect the 1.5 mmHg treatment difference with 3.75 mmHg of the standard deviation at a power of 90% in two-sided t tests with a 0.05 level of confidence. One hundred and forty six subjects per group (total of 292) were planned to allow for drop outs and withdrawals.|
1747536|NCT00382993|3211395|Superiority or Other||Odds Ratio (OR)|5.63|||<|0.001||95.0|2.76|11.49|||ANOVA||||
1747537|NCT00382863|3211402|Superiority or Other|||||||0.772|||||||Wilcoxon (Mann-Whitney)|Two-sided|||
1747538|NCT00382863|3211403|Superiority or Other|||||||0.001|||||||Log Rank||||
1747539|NCT00382863|3211404|Superiority or Other|||||||0.012|||||||Fisher Exact|Two-sided|||
1747540|NCT00382863|3211405|Superiority or Other|||||||0.939|||||||Log Rank||||
1747541|NCT00382863|3211406|Superiority or Other|||||||1|||||||Fisher Exact|Two-sided|||
1747542|NCT00382863|3211407|Superiority or Other|||||||0.154|||||||Fisher Exact|Two-sided|||
1747543|NCT00382863|3211408|Superiority or Other|||||||0.386|||||||Log Rank||||
1747544|NCT00382863|3211409|Superiority or Other|||||||0.627|||||||Fisher Exact|Two-sided|||
1747545|NCT00382863|3211411|Superiority or Other|||||||0.032|||||||Wilcoxon (Mann-Whitney)|Two-sided|||
1747546|NCT00382863|3211412|Superiority or Other|||||||0.015|||||||Wilcoxon (Mann-Whitney)|Two-sided|||
1747547|NCT00382863|3211413|Superiority or Other|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Two-sided|||
1747548|NCT00382863|3211414|Superiority or Other|||||||0.179|||||||Wilcoxon (Mann-Whitney)|Two-sided|||
1747549|NCT00382863|3211415|Superiority or Other|||||||0.031|||||||Wilcoxon (Mann-Whitney)|Two-sided|||
1747550|NCT00382863|3211416|Superiority or Other|||||||0.109|||||||Log Rank|||Kaplan-Meier actuarial time-to-first-event analysis|
1747551|NCT00382863|3211417|Superiority or Other|||||||0.031|||||||Fisher Exact|One-sided||Improvement of at least 7 points from baseline.|
1747552|NCT00382863|3211418|Superiority or Other|||||||0.067|||||||Fisher Exact|One-sided||Improvement of at least 45 m from baseline.|
1747553|NCT00382863|3211419|Superiority or Other|||||||0.54|||||||Fisher Exact|One-sided||Improvement of at least 1.0 ml/kg/min from baseline.|
1747554|NCT00382863|3211420|Superiority or Other|||||||0.032|||||||Wilcoxon (Mann-Whitney)|Two-sided|||
1747555|NCT00382863|3211421|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1747556|NCT00382863|3211422|Superiority or Other|||||||0.052|||||||Wilcoxon (Mann-Whitney)|||Class change from baseline.|
1747557|NCT00382863|3211423|Non-Inferiority or Equivalence|Estimated survival for the treatment group was 93%. Estimated survival for the control group was 91.5%. A non-inferiority margin of 7.5%. Final test alpha level of 0.04825.||||||0.012|||||||Exact binomial test|One-sided||The null hypothesis = survival in the treatment group at 12 months is not equivalent to that of the Control group.|
1747558|NCT00382863|3211424|Superiority or Other|||||||0.184|||||||Fisher Exact|One-sided||The null hypothesis = the proportion of treatment subjects who successfully achieved an improvement of at least 7 points at 6 months is equal to or less than that of the control group. Withdrawals due to cardiac reasons are counted as non-responders.|
1747559|NCT00382863|3211425|Superiority or Other|||||||0.044|||||||Fisher Exact|One-sided||The null hypothesis = the proportion of subjects in the treatment group who successfully achieved an improvement of at least 45 m at 6 months from baseline is less than or equal to that of the Control group. Withdrawals due to cardiac reasons are counted as non-responders.|
1747560|NCT00382863|3211426|Superiority or Other|||||||0.502|||||||Fisher Exact|One-sided||Null hypothesis = proportion of subjects in treatment group who successfully achieved an improvement of at least 1.0 ml/kg/min at 6 months is less than or equal to the Control group. Subjects who withdrew for cardiac-related reasons were classified as non-responders.|
1747561|NCT00382785|3211432|Superiority or Other|||||||0.32|||||||Univariate Analysis|||Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in quality of life (QOL) based on type of online support group (moderated or peer-led).|
1747562|NCT00382785|3211433|Superiority or Other|||||||0.23|||||||univariate analysis|Null Hypothesis: There will be no difference between the moderated and peer-led groups based on type of online support (moderated; peer-led)||Power analysis indicated that 60 subjects were needed. Null hypothesis: There will be no difference in depressive symptoms based on type of online support group (moderated or peer-led).|
1747563|NCT00382785|3211434|Superiority or Other|||||||0.315|||||||univariate analysis|||Power calculation indicated that 60 subjects would be needed. Null Hypothesis: There will be no difference in perceived social support based on type of online support group (moderated or peer-led).|
1747564|NCT00382408|3211446|Superiority or Other||vaccine efficacy (VE)|98.46|||||2-Sided|95.0|95.39|99.49||||||The vaccine efficacy (VE) was defined as: VE = 1 - R, where R = P(vaccine)/P(placebo) was the relative risk of ARD attack in subjects who received vaccines compared to placebos (Blackwelder 1993). The 95% confidence interval of the VE was obtained by inverting the Chi Square method proposed by Koopman for the ratio of two binomial proportions (Koopman 1984). The goal of the analysis of efficacy was to demonstrate a VE of at least 80% with a lower 95% confidence bound at least 60%.|
1747565|NCT00382408|3211451|Superiority or Other||vaccine efficacy (VE)|99.31|||||2-Sided|95.0|96.02|99.88||||||The vaccine efficacy (VE) was defined as: VE = 1 - R, where R = P(vaccine)/P(placebo) was the relative risk of ARD attack in subjects who received vaccines compared to placebos (Blackwelder 1993). The 95% confidence interval of the VE was obtained by inverting the Chi Square method proposed by Koopman for the ratio of two binomial proportions (Koopman 1984). The goal of the analysis of efficacy was to demonstrate a VE of at least 80% with a lower 95% confidence bound at least 60%.|
1747566|NCT00382291|3211452|Superiority or Other|||||||0.8831|||||||ANCOVA|||Data were analyzed using ANCOVA modeling with two-sided testing and level of significance = .05. The dependent variable was last measured CY-BOCS score, the independent variable was randomized group assignment and the covariate was the CY-BOCS score at baseline. The null hypothesis was that there were no group differences.|
1747567|NCT00382291|3211453|Superiority or Other|||||||0.2106|||||||Kruskal-Wallis|||Data were analyzed using two-sided Kruskal-Wallis test with level of significance = .05. Null hypothesis was that there were no group differences. The maximum CGI-SA obtained over course of study was the outcome measure.|
1747568|NCT00382018|3211483|Superiority or Other||Hazard Ratio (HR)|0.92||||0.64|2-Sided|95.0|0.64|1.32|||Log Rank|||Hazard Ratio of progression free survival compared Arm C2 to Arm C1|
1747569|NCT00382018|3211484|Superiority or Other||Hazard Ratio (HR)|1.0||||0.98|2-Sided|95.0|0.69|1.47|||Log Rank|||Hazard Ration of overall survival compared Arm C2 to Arm C1.|
1747570|NCT00381849|3211500|Superiority or Other|||||||0.13|||||||t-test, 2 sided|||Left Kidney Stone Volume; P-value comparing one year to baseline|
1747571|NCT00381849|3211500|Superiority or Other|||||||0.96|||||||t-test, 2 sided|||Right Kidney Stone Volume; P-value comparing one year to baseline|
1747572|NCT00381849|3211500|Superiority or Other|||||||0.78|||||||t-test, 2 sided|||Left Kidney Stone Volume; P-value comparing one year to baseline|
1747573|NCT00381849|3211500|Superiority or Other|||||||0.81|||||||t-test, 2 sided|||Right Kidney Stone Volume; P-value comparing one year to baseline|
1747574|NCT00381849|3211501|Superiority or Other|||||||0.15|||||||t-test, 2 sided|||Left Kidney Stone Density; P-value comparing one year to baseline|
1747575|NCT00381849|3211501|Superiority or Other|||||||0.97|||||||t-test, 2 sided|||Right Kidney Stone Density; P-value comparing one year to baseline|
1747576|NCT00381849|3211501|Superiority or Other|||||||0.63|||||||t-test, 2 sided|||Left Kidney Stone Density; P-value comparing one year to baseline|
1747577|NCT00381849|3211501|Superiority or Other|||||||0.85|||||||t-test, 2 sided|||Right Kidney Stone Density; P-value comparing one year to baseline|
1747578|NCT00381849|3211502|Superiority or Other|||||||0.2|||||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 46 weeks' treatment on cystone.|
1747579|NCT00381849|3211502|Superiority or Other|||||||0.15|||||||t-test, 1 sided|||Paired t test for urinary cystine between six weeks' treatment on cystone and 6 weeks' treatment on placebo.|
1747580|NCT00381849|3211502|Superiority or Other|||||||0.25|||||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 6 weeks' treatment on cystone.|
1747581|NCT00381849|3211502|Superiority or Other|||||||0.69|||||||t-test, 1 sided|||Paired t test for urinary cystine between baseline and after 6 weeks' treatment on placebo.|
1747582|NCT00381849|3211505|Superiority or Other|||||||0.84|||||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 46 weeks' treatment on cystone.|
1747583|NCT00381849|3211505|Superiority or Other|||||||0.72|||||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between six weeks' treatment on cystone and 6 weeks' treatment on placebo.|
1747584|NCT00381849|3211505|Superiority or Other|||||||0.64|||||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on cystone.|
1747585|NCT00381849|3211505|Superiority or Other|||||||0.49|||||||t-test, 1 sided|||Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on placebo.|
1747586|NCT00381849|3211506|Superiority or Other|||||||0.32|||||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 46 weeks' treatment on cystone.|
1747587|NCT00381849|3211506|Superiority or Other|||||||0.41|||||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between six weeks' treatment on cystone and 6 weeks' treatment on placebo.|
1747588|NCT00381849|3211506|Superiority or Other|||||||0.23|||||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on cystone.|
1747589|NCT00381849|3211506|Superiority or Other|||||||0.32|||||||t-test, 1 sided|||Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on placebo.|
1747590|NCT00381641|3211555|Superiority|"Null (historical) response rate for iodine refractory subgroup is 10%. Power=90% for 30% alternative.~Null (historical) response rate for metastatic medullary subgroup is 5%. Power=88% for 25% alternative."|||||<|0.1||||||"For iodine refractory subgroup, null hypothesis could be rejected if 6 or more responses were observed.~For metastatic medullary subgroup, null hypothesis could be rejected if 3 or more responses were observed."|Simon, two-stage design|||Note. The objective was not to compare the two arms (subgroups), but to compare each with historical data.|
1747591|NCT00381485|3211582|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1747592|NCT00381485|3211582|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1747593|NCT00381303|3211596|Non-Inferiority or Equivalence|Test for non-inferiority (Delta=15%)|Mean Difference (Final Values)|-9.6|Standard Error of the Mean|0.052||0.3|2-Sided|95.0|-19.85|0.68||P-Value for difference (Female - Male): Test for non-inferiority (Delta=15%)|Regression, Logistic|Estimates from logistic regression analysis include baseline log10 viral load and baseline CD4 cell count as covariates and gender as a factor.||"Confidence interval of the difference in proportion of response between two sexes estimated by:~Application of delta method to be obtained Standard Error (SE)~Calculation of lower and upper bound using normal approximation to the difference in response rates"|
1747594|NCT00380978|3211631|Superiority or Other||||||<|0.005|||||||Chi-squared, Corrected||||
1747595|NCT00380978|3211632|Superiority or Other|||||||0.11|||||||Fisher Exact||||
1747596|NCT00380978|3211633|Superiority or Other||||||<|0.005|||||||Chi-squared, Corrected||||
1747597|NCT00380978|3211634|Superiority or Other||Median Difference (Final Values)|-4.0|||<|0.005|2-Sided|95.0|-4.0|-3.0|||Wilcoxon (Mann-Whitney)||||
1747598|NCT00380978|3211635|Superiority or Other|||||||0.35|||||||Chi-squared||||
1747599|NCT00380978|3211636|Superiority or Other|||||||0.047|||||||Log Rank||||
1747600|NCT00380978|3211637|Superiority or Other||Risk Ratio (RR)|0.98||||0.63|2-Sided|95.0|0.8|1.2|||Chi-squared|||There rate of instrumented vaginal delivery will be equal in both groups.|
1747601|NCT00380978|3211638|Non-Inferiority or Equivalence|Equivalence|Risk Ratio (RR)|1.04||||0.65|2-Sided|95.0|0.9|1.2|||Chi-squared, Corrected|||Group sample sizes of 800 in each group achieve 80% power to detect equivalence when the margin of equivalence extends from 0.1 to 0.25|
1747602|NCT00380874|3211639|Superiority or Other||Median Difference (Final Values)|-0.16|Standard Error of the Mean|0.49||0.7489||95.0||||No multiple comparisons adjustment was necessary.|ANCOVA|Model terms include treatment, study center, and baseline score.|Least squares (LS) means and corresponding standard errors derived from ANCOVA model were used.|LOCF cycle endpoint. Sample size based on original primary efficacy parameter (PEP) of time to persistent symptoms (developing in 35% of pregabalin subjects & 60% of placebo subjects). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, study would have had at least 90% power using 100 subjects per treatment group. Original PEP was modified to secondary due to lack of persistent paresthetic symptom emergence.|
1747603|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.01||0.8957||95.0|-0.02|0.02|||ANCOVA|||Total Score LOCF Endpoint|
1747604|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.01||0.9694||95.0|-0.03|0.03|||ANCOVA|||Total Score Cycle 9|
1747605|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.02||0.2226||95.0|-0.01|0.05|||ANCOVA|||Total Score Cycle 8|
1747606|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.01||0.3403||95.0|-0.01|0.04|||ANCOVA|||Total Score Cycle 7|
1747607|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.01||0.9854||95.0|-0.02|0.02|||ANCOVA|||Total Score Cycle 6|
1747608|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.0||0.9865||95.0|-0.01|0.01|||ANCOVA|||Total Score Cycle 5|
1747609|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.0||0.5931||95.0|-0.01|0.01|||ANCOVA|||Total Score Cycle 4|
1747610|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.0||0.2824||95.0|0.0|0.01|||ANCOVA|||Total Score Cycle 3|
1747611|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.0||0.3557||95.0|0.0|0.01|||ANCOVA|||Total Score Cycle 2|
1747612|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.31|Standard Error of the Mean|0.34||0.3628||95.0|-0.37|1.0|||ANCOVA|||Parethesia/Dysesthesia Pain LOCF Endpoint|
1747613|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.49||0.5217||95.0|-0.68|1.33|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 9|
1747614|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.51|Standard Error of the Mean|0.47||0.2806||95.0|-0.44|1.46|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 8|
1747615|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.31|Standard Error of the Mean|0.32||0.3445||95.0|-0.34|0.95|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 7|
1747616|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.36|Standard Error of the Mean|0.33||0.2809||95.0|-0.31|1.03|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 6|
1747617|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.21||0.0608||95.0|-0.02|0.83|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 5|
1747618|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.37|Standard Error of the Mean|0.17||0.0331||95.0|0.03|0.7|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 4|
1747619|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.15||0.1819||95.0|-0.1|0.5|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 3|
1747620|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.12||0.0416||95.0|0.01|0.5|||ANCOVA|||Parethesia/Dysesthesia Pain Cycle 2|
1747621|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.27||0.9273||95.0|-0.51|0.56|||ANCOVA|||Evoke Pain LOCF Endpoint|
1747622|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.37||0.6863||95.0|-0.6|0.9|||ANCOVA|||Evoke Pain Cycle 9|
1747627|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.12||0.2748||95.0|-0.37|0.11|||ANCOVA|||Evoke Pain Cycle 4|
1747628|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.17||0.5867||95.0|-0.25|0.44|||ANCOVA|||Evoke Pain Cycle 3|
1747629|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.08||0.9931||95.0|-0.17|0.17|||ANCOVA|||Evoke Pain Cycle 2|
1747630|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.15||0.5208||95.0|-0.39|0.2|||ANCOVA|||Paroxysmal Pain LOCF Endpoint|
1747631|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.24||0.4093||95.0|-0.69|0.29|||ANCOVA|||Paroxysmal Pain Cycle 9|
1747632|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.35||0.366||95.0|-0.38|1.02|||ANCOVA|||Paroxysmal Pain Cycle 8|
1747633|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.23||0.9636||95.0|-0.46|0.48|||ANCOVA|||Paroxysmal Pain Cycle 7|
1747634|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.12||0.3035||95.0|-0.38|0.12|||ANCOVA|||Paroxysmal Pain Cycle 6|
1747635|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.1||0.3058||95.0|-0.31|0.1|||ANCOVA|||Paroxysmal Pain Cycle 5|
1747636|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.1||0.4482||95.0|-0.26|0.12|||ANCOVA|||Paroxysmal Pain Cycle 4|
1747637|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.02||0.3011||95.0|-0.06|0.02|||ANCOVA|||Paroxysmal Pain Cycle 3|
1747638|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.09||0.4113||95.0|-0.1|0.24|||ANCOVA|||Pressing Spontaneous Pain LOCF Endpoint|
1747639|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.12||0.4017||95.0|-0.14|0.35|||ANCOVA|||Pressing Spontaneous Pain Cycle 9|
1747640|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.27|Standard Error of the Mean|0.21||0.2199||95.0|-0.17|0.7|||ANCOVA|||Pressing Spontaneous Pain Cycle 8|
1747641|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Deviation|0.25||0.885||95.0|-0.54|0.47|||ANCOVA|||Pressing Spontaneous Pain Cycle 7|
1747642|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.07||0.9793||95.0|-0.13|0.13|||ANCOVA|||Pressing Spontaneous Pain Cycle 6|
1747643|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.06||0.9568||95.0|-0.12|0.11|||ANOVA|||Pressing Spontaneous Pain Cycle 5|
1747644|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.12||0.163||95.0|-0.4|0.07|||ANCOVA|||Pressing Spontaneous Pain Cycle 4|
1747645|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.04||0.3747||95.0|-0.04|0.12|||ANCOVA|||Pressing Spontaneous Pain Cycle 3|
1747646|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.06||0.3022||95.0|-0.17|0.05|||ANCOVA|||Pressing Spontaneous Pain Cycle 2|
1747647|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.26||0.9614||95.0|-0.54|0.51|||ANCOVA|||Burning Spontaneous Pain LOCF endpoint|
1747648|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.39||0.8918||95.0|-0.84|0.74|||ANCOVA|||Burning Spontaneous Pain|
1747649|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.31||0.3383||95.0|-0.33|0.92|||ANOVA|||Burning Spontaneous Pain Cycle 8|
1747650|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.35||0.9541||95.0|-0.68|0.73|||ANCOVA|||Burning Spontaneous Pain Cycle 7|
1747651|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.17||0.4124||95.0|-0.2|0.47|||ANCOVA|||Burning Spontaneous Pain Cycle 6|
1747652|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.12||0.2787||95.0|-0.37|0.11|||ANCOVA|||Burning Spontaneous Pain Cycle 5|
1747653|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.13||0.3062||95.0|-0.4|0.13|||ANCOVA|||Burning Spontaneous Pain Cycle 4|
1747654|NCT00380874|3211641|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.09||0.2034||95.0|-0.06|0.29|||ANCOVA|||Burning Spontaneous Pain Cycle 3|
1747655|NCT00380874|3211642|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.39||0.7359||95.0|-0.9|0.64|||ANCOVA|||LOCF endpoint.|
1747656|NCT00380874|3211642|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.58||0.8499||95.0|-1.29|1.07|||ANCOVA|||Cycle 9.|
1747657|NCT00380874|3211642|Superiority or Other||Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.49||0.5103||95.0|-0.67|1.33|||ANCOVA||||
1747658|NCT00380874|3211642|Superiority or Other||Mean Difference (Final Values)|0.33|Standard Error of the Mean|0.42||0.4357||95.0|-0.52|1.17|||ANCOVA|||Cycle 7.|
1747659|NCT00380874|3211642|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.38||0.9181||95.0|-0.81|0.73|||ANCOVA|||Cycle 6.|
1747660|NCT00380874|3211642|Superiority or Other||Mean Difference (Final Values)|0.54|Standard Error of the Mean|0.49||0.2712||95.0|-0.44|1.52|||ANCOVA|||Cycle 5.|
1747661|NCT00380874|3211642|Superiority or Other||Mean Difference (Final Values)|0.34|Standard Error of the Mean|0.41||0.4059||95.0|-0.48|1.17|||ANCOVA|||Cycle 4.|
1747662|NCT00380874|3211642|Superiority or Other||Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.34||0.5358||95.0|-0.48|0.9|||ANCOVA|||Cycle 3.|
1747663|NCT00380874|3211642|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.22||0.5412||95.0|-0.3|0.57|||ANCOVA|||Cycle 2.|
1747664|NCT00380874|3211642|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.09||0.5392||95.0|-0.24|0.12|||ANCOVA|||Cycle 1.|
1747776|NCT00380081|3211750|Superiority or Other||||||<|0.001||||||Treatment effect|ANCOVA||||
1747665|NCT00380874|3211643|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.54||0.9657||95.0|-1.06|1.11||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Last Observation Carried Forward (LOCF)endpoint.|
1747666|NCT00380874|3211643|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.62||0.4209||95.0|-1.77|0.76||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 9.|
1747667|NCT00380874|3211643|Superiority or Other||Mean Difference (Final Values)|0.27|Standard Error of the Mean|0.55||0.6265||95.0|-0.85|1.38|||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 8.|
1747668|NCT00380874|3211643|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.53||0.9952||95.0|-1.06|1.07|||ANCOVA|Model terms include treatment, study center, and baseline score.||Cycle 7.|
1747669|NCT00380874|3211643|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.54||0.9276||95.0|-1.15|1.05||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 6.|
1747670|NCT00380874|3211643|Superiority or Other||Mean Difference (Final Values)|0.75|Standard Error of the Mean|0.7||0.2925||95.0|-0.67|2.16||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 5.|
1747671|NCT00380874|3211643|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.55||0.5812||95.0|-0.8|1.41||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 4.|
1747672|NCT00380874|3211643|Superiority or Other||Mean Difference (Final Values)|0.26|Standard Error of the Mean|0.48||0.5925||95.0|-0.7|1.22||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 3.|
1747673|NCT00380874|3211643|Superiority or Other||Mean Difference (Final Values)|0.37|Standard Error of the Mean|0.36||0.3111||95.0|-0.36|1.1||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 2.|
1747674|NCT00380874|3211643|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.11||0.7207||95.0|-0.25|0.17||Model terms include treatment, study center, and baseline score.|ANCOVA|Cycle 1. No multiple comparisons adjustment was made.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 1.|
1747675|NCT00380874|3211644|Superiority or Other||Mean Difference (Final Values)|-0.73|Standard Error of the Mean|0.5||0.1569||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 9.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.|
1747676|NCT00380874|3211644|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.4||0.6233|||||||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 8. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.|
1747677|NCT00380874|3211644|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.4||0.9359|||||||ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 7. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.|
1747678|NCT00380874|3211644|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.41||0.8169||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 6.Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.|
1747679|NCT00380874|3211644|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.49||0.3125||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 5. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.|
1747777|NCT00380081|3211751|Superiority or Other||||||<|0.001||||||Treatment effect|ANCOVA||||
1747680|NCT00380874|3211644|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.31||0.4301||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 4. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.|
1747681|NCT00380874|3211644|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.3||0.6065||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 3. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.|
1747682|NCT00380874|3211644|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.23||0.5757||||||No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 2. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.|
1747683|NCT00380874|3211644|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.08||0.2536||||||Cycle 1. No multiple comparisons adjustment was made.|ANCOVA|Model terms include treatment, study center, and baseline score.|LS means and corresponding standard errors derived from ANCOVA model were used.|Cycle 1. Sample size was based on original primary efficacy parameter (PEP) of time to persistent paresthesia symptoms (symptoms developing in 35% of subjects taking pregabalin and 60% taking placebo symptoms). Assuming Type I error rate of 0.05 and a 2-sided log-rank test for equality of time to persistent symptoms survival curves, the study would have had at least 90% power using 100 subjects per treatment group. The original PEP was modified to secondary due to lack of symptom emergence.|
1747684|NCT00380692|3211669|Superiority or Other||Mean Difference (Net)|18.6|Standard Error of the Mean|31.9||0.564||95.0|-47.0|84.3||P-value for Treatment*Condition Mean Reaction Time correct rejections Load 2 over time.|Mixed Models Analysis||||
1747685|NCT00380692|3211669|Superiority or Other||Mean Difference (Net)|-22.0|Standard Error of the Mean|68.9||0.752||95.0|-163.1|119.1||P-value for Treatment differences in Reaction Time over time.|Mixed Models Analysis||||
1747686|NCT00380692|3211670|Superiority or Other||Mean Difference (Net)|2.1|Standard Error of the Mean|2.0||0.307||95.0|-2.1|6.3||P-value for Treatment*Condition Error Rates compatible signals over time.|Mixed Models Analysis||||
1747687|NCT00380692|3211670|Superiority or Other||Mean Difference (Net)|-3.6|Standard Error of the Mean|2.9||0.221||95.0|-9.6|2.3||P-value for Treatment differences in Error Rates over time.|Mixed Models Analysis||||
1747688|NCT00380692|3211671|Superiority or Other||Mean Difference (Net)|-7.0|Standard Error of the Mean|2.4||0.005||95.0|-11.8|-2.2||P-value for Treatment*Condition Error Rate irrelevant targets over time.|Mixed Models Analysis||||
1747689|NCT00380692|3211671|Superiority or Other||Mean Difference (Net)|1.6|Standard Error of the Mean|2.0||0.43||95.0|-2.4|5.7||P-value for Treatment difference in Error Rate over time.|Mixed Models Analysis||||
1747690|NCT00380692|3211672|Superiority or Other||Mean Difference (Net)|-6.1|Standard Error of the Mean|2.4||0.022||95.0|-11.2|-1.0||P-value for Treatment difference in Stability of Movement over time.|Mixed Models Analysis||||
1747691|NCT00380692|3211673|Superiority or Other||Mean Difference (Net)|-7.3|Standard Error of the Mean|4.6||0.128||95.0|-16.9|2.3||P-value for Treatment difference in Accuracy over time.|Mixed Models Analysis||||
1747692|NCT00380692|3211674|Superiority or Other||Mean Difference (Net)|205.5|Standard Error of the Mean|99.9||0.042||95.0|7.5|403.6||P-value for Treatment*Condition Standard Deviation hits Load 1 over time.|Mixed Models Analysis||||
1747693|NCT00380692|3211674|Superiority or Other||Mean Difference (Net)|173.6|Standard Error of the Mean|105.6||0.103||95.0|-35.7|383.0||P-value for Treatment*Condition Standard Deviation correct rejections Load 2 over time.|Mixed Models Analysis||||
1747694|NCT00380692|3211674|Superiority or Other||Mean Difference (Net)|218.1|Standard Error of the Mean|90.8||0.018||95.0|38.0|398.2||P-value for Treatment*Condition Standard Deviation correct rejections Load 1 over time.|Mixed Models Analysis||||
1747695|NCT00380692|3211674|Superiority or Other||Mean Difference (Net)|-175.5|Standard Error of the Mean|88.0||0.051||95.0|-351.5|0.5||P-value for Treatment differences in Standard Deviation of Reaction Time over time.|Mixed Models Analysis||||
1747696|NCT00380692|3211675|Superiority or Other||Mean Difference (Net)|122.7|Standard Error of the Mean|80.1||0.128||95.0|-35.9|281.4||P-value for Treatment*Condition Mean Reaction Time hits Load 1 over time.|Mixed Models Analysis||||
1747697|NCT00380692|3211675|Superiority or Other||Mean Difference (Net)|70.4|Standard Error of the Mean|59.5||0.239||95.0|-47.3|188.2||P-value for Treatment*Condition Mean Reaction Time correct rejections Load 2 over time.|Mixed Models Analysis||||
1747698|NCT00380692|3211675|Superiority or Other||Mean Difference (Net)|87.6|Standard Error of the Mean|77.3||0.26||95.0|-65.6|240.8||P-value for Treatment*Condition Mean Reaction Time correct rejections Load 1 over time.|Mixed Models Analysis||||
1747699|NCT00380692|3211675|Superiority or Other||Mean Difference (Net)|-87.2|Standard Error of the Mean|71.7||0.228||95.0|-230.4|56.0||P-value for Treatment differences in Reaction Time over time.|Mixed Models Analysis||||
1747700|NCT00380692|3211676|Superiority or Other||Mean Difference (Net)|-5.1|Standard Error of the Mean|2.1||0.023||95.0|-9.4|-0.7||P-value for Treatment*Targets Load 1 over time.|Mixed Models Analysis||||
1747701|NCT00380692|3211676|Superiority or Other||Mean Difference (Net)|-1.8|Standard Error of the Mean|1.7||0.297||95.0|-5.2|1.6||P-value for Treatment*Error Rate absent over time.|Mixed Models Analysis||||
1747702|NCT00380692|3211676|Superiority or Other||Mean Difference (Net)|4.3|Standard Error of the Mean|2.8||0.126||95.0|-1.2|9.9||P-value for Treatment differences in Error Rate over time.|Mixed Models Analysis||||
1747703|NCT00380692|3211677|Superiority or Other||Mean Difference (Net)|13.6|Standard Error of the Mean|67.1||0.84||95.0|-119.3|146.5||P-value for Treatment*Condition Standard Deviation correct rejections relevant nontarget over time.|Mixed Models Analysis||||
1747704|NCT00380692|3211677|Superiority or Other||Mean Difference (Net)|-80.9|Standard Error of the Mean|77.5||0.299||95.0|-234.3|72.5||P-value for Treatment*Condition Standard Deviation correct rejections irrelevant target over time.|Mixed Models Analysis||||
1747705|NCT00380692|3211677|Superiority or Other||Mean Difference (Net)|-21.3|Standard Error of the Mean|65.9||0.748||95.0|-152.8|110.3||P-value for Treatment differences in Standard Deviation of Reaction Time over time.|Mixed Models Analysis||||
1747706|NCT00380692|3211678|Superiority or Other||Mean Difference (Net)|7.0|Standard Error of the Mean|57.7||0.904||95.0|-107.1|121.1||P-value for Treatment*Condition Mean Reaction Time correct rejections relevant nontarget over time.|Mixed Models Analysis||||
1747707|NCT00380692|3211678|Superiority or Other||Mean Difference (Net)|-37.1|Standard Error of the Mean|62.3||0.553||95.0|-160.3|86.2||P-value for Treatment*Condition Mean Reaction Time correct rejections irrelevant target over time.|Mixed Models Analysis||||
1747708|NCT00380692|3211678|Superiority or Other||Mean Difference (Net)|-61.9|Standard Error of the Mean|66.0||0.352||95.0|-193.5|69.8||P-value for Treatment differences in Reaction time over time.|Mixed Models Analysis||||
1747709|NCT00380692|3211679|Superiority or Other||Mean Difference (Net)|1.7|Standard Deviation|3.1||0.57||95.0|-4.3|7.8||P-value for Treatment*Condition Error Rate relevant nontargets over time.|Mixed Models Analysis||||
1747710|NCT00380692|3211679|Superiority or Other||Mean Difference (Net)|-2.9|Standard Error of the Mean|3.5||0.399||95.0|-9.7|3.9||P-value for Treatment*Condition Error Rate irrelevant targets over time.|Mixed Models Analysis||||
1747711|NCT00380692|3211679|Superiority or Other||Mean Difference (Net)|-0.2|Standard Error of the Mean|2.7||0.948||95.0|-5.5|5.2||P-value for treatment differences in Error Rate over time.|Mixed Models Analysis||||
1747712|NCT00380692|3211680|Superiority or Other||Mean Difference (Net)|-11.2|Standard Error of the Mean|11.12||0.318||95.0|-33.3|11.0||P-value for treatment differences in Total score at 8 weeks.|ANCOVA||||
1747713|NCT00380692|3211681|Superiority or Other||Mean Difference (Net)|-0.3|Standard Error of the Mean|0.64||0.598||95.0|-1.6|0.9||P-value for treatment differences in Total score at 8 weeks.|ANCOVA||||
1747714|NCT00380692|3211682|Superiority or Other||Mean Difference (Net)|-3.9|Standard Error of the Mean|2.13||0.069||95.0|-8.1|0.3||P-value for treatment differences in Total score at 8 weeks.|ANCOVA||||
1747715|NCT00380692|3211683|Superiority or Other||Mean Difference (Net)|-0.9|Standard Error of the Mean|0.42||0.045||95.0|-1.7|0.0||P-value for treatment differences in Inappropriate speech score at 8 weeks.|ANCOVA||||
1747716|NCT00380692|3211683|Superiority or Other||Mean Difference (Net)|-4.4|Standard Error of the Mean|1.68||0.01||95.0|-7.8|-1.1||P-value for treatment differences in Hyperactivity score at 8 weeks.|ANCOVA||||
1747717|NCT00380692|3211683|Superiority or Other||Mean Difference (Net)|-1.6|Standard Error of the Mean|0.63||0.014||95.0|-2.8|-0.3||P-value for treatment differences in Stereotypic score at 8 weeks.|ANCOVA||||
1747718|NCT00380692|3211683|Superiority or Other||Mean Difference (Net)|-0.2|Standard Error of the Mean|1.1||0.85||95.0|-2.4|2.0||P-value for treatment differences in Lethargy score at 8 weeks.|ANCOVA||||
1747719|NCT00380692|3211683|Superiority or Other||Mean Difference (Net)|-1.0|Standard Error of the Mean|1.29||0.452||95.0|-3.5|1.6||P-value for treatment differences in Irritability score at 8 weeks.|ANCOVA||||
1747720|NCT00380692|3211684|Superiority or Other||Mean Difference (Net)|-1.1|Standard Error of the Mean|0.87||0.188||95.0|-2.9|0.6||P-value for treatment differences in Functional outcome during day score at 8 weeks.|ANCOVA||||
1747721|NCT00380692|3211684|Superiority or Other||Mean Difference (Net)|-0.8|Standard Error of the Mean|0.49||0.112||95.0|-1.7|0.2||P-value for treatment differences in Quality of sleep score at 8 weeks.|ANCOVA||||
1747722|NCT00380692|3211684|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.24||0.652||95.0|-0.6|0.4||P-value for treatment differences in Total hours of sleep score at 8 weeks.|ANCOVA||||
1747723|NCT00380692|3211684|Superiority or Other||Mean Difference (Net)|0.3|Standard Error of the Mean|0.3||0.407||95.0|-0.3|0.9||P-value for treatment differences in Difficulty falling asleep score at 8 weeks.|ANCOVA||||
1747724|NCT00380692|3211684|Superiority or Other||Mean Difference (Net)|-0.5|Standard Error of the Mean|0.24||0.028||95.0|-1.0|-0.1||P-value for treatment differences in Time to fall asleep score at 8 weeks.|ANCOVA||||
1747725|NCT00380692|3211686|Superiority or Other||Mean Difference (Net)|-2.7|Standard Error of the Mean|1.48||0.077||95.0|-5.6|0.3||P-value for treatment differences in ADHD score at 8 weeks|ANCOVA||||
1747726|NCT00380692|3211686|Superiority or Other||Mean Difference (Net)|-0.7|Standard Error of the Mean|0.51||0.179||95.0|-1.7|0.3||P-value for treatment differences in Cognititve/Attention score at 8 weeks.|ANCOVA||||
1747727|NCT00380692|3211686|Superiority or Other||Mean Difference (Net)|-2.0|Standard Error of the Mean|0.87||0.024||95.0|-3.7|-0.3||P-value for treatment differences in Hyperactivity score at 8 weeks|ANCOVA||||
1747728|NCT00380692|3211686|Superiority or Other||Mean Difference (Net)|-0.6|Standard Error of the Mean|0.61||0.369||95.0|-1.8|0.7||P-value for treatment differences in Oppositional Score at 8 weeks.|ANCOVA||||
1747729|NCT00380692|3211687|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.2||0.921||95.0|-0.5|0.4||P-value for treatment differences over time.|Mixed Models Analysis||||
1747730|NCT00380692|3211688|Superiority or Other||Mean Difference (Net)|-6.7|Standard Error of the Mean|1.7|<|0.001||95.0|-10.0|-3.4||P-value for treatment group differences over time.|Mixed Models Analysis||||
1747731|NCT00380588|3211689|Superiority or Other|||||||0.136|||||||Log Rank||||
1747732|NCT00380588|3211690|Superiority or Other|||||||0.074|||||||Log Rank||||
1747734|NCT00380393|3211711|Other||Vaccine efficacy|59.5|||<|0.001|2-Sided|95.0|37.1|73.9|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.|
1747735|NCT00380393|3211711|Other||Vaccine efficacy|58.0|||<|0.001|2-Sided|95.0|34.8|73.0|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.|
1747736|NCT00380393|3211712|Other||Vaccine efficacy|57.9|||<|0.001|2-Sided|95.0|34.3|73.0|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.|
1747737|NCT00380393|3211712|Other||Vaccine efficacy|55.8|||<|0.0003|2-Sided|95.0|31.0|71.7|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.|
1747738|NCT00380393|3211713|Other||Vaccine efficacy|56.5|||<|0.001|2-Sided|95.0|34.2|71.2|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.|Vaccine efficacy against P. falciparum.|
1747739|NCT00380393|3211713|Other||Vaccine efficacy|54.6|||<|0.001|2-Sided|95.0|31.2|70.0|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum.|
1747740|NCT00380393|3211714|Other||Vaccine Efficacy|55.0|||<|0.001|2-Sided|95.0|31.4|70.4|||Regression, Cox||Point estimate of VE was not adjusted for site, age, bednet use, area or distance from health center.|Vaccine efficacy against P. falciparum|
1747741|NCT00380393|3211714|Other||Vaccine Efficacy|52.9|||<|0.001|2-Sided|95.0|28.1|69.1|||Regression, Cox||Point estimate of VE was adjusted for site, age, bednet use, area and distance from health center.|Vaccine efficacy against P. falciparum|
1747742|NCT00380250|3211717|Superiority or Other (legacy)||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center|||
1747743|NCT00380250|3211718|Superiority or Other (legacy)||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center|||
1747744|NCT00380250|3211719|Superiority or Other (legacy)||||||<|0.001|||||||van Elteren nonparametric test|Adjusted for center|||
1747745|NCT00380250|3211720|Superiority or Other (legacy)|||||||0.491|||||||van Elteren nonparametric test||||
1747746|NCT00380250|3211721|Superiority or Other (legacy)|||||||0.483|||||||van Elteren nonparametric test||||
1747747|NCT00380250|3211722|Superiority or Other (legacy)|||||||0.108|||||||van Elteren nonparametric test||||
1747748|NCT00380250|3211723|Superiority or Other (legacy)|||||||0.615|||||||van Elteren nonparametic test|Adjusted for center|||
1747749|NCT00380250|3211724|Superiority or Other (legacy)|||||||0.168|||||||Cochran-Mantel-Haenszel|Adjusted by pooled center|||
1747750|NCT00380250|3211725|Superiority or Other (legacy)|||||||0.144|||||||Cochran-Mantel-Haenszel|Stratified by pooled center|||
1747751|NCT00380250|3211726|Superiority or Other (legacy)|||||||0.111|||||||van Elteren nonparametric test||||
1747752|NCT00380250|3211727|Superiority or Other (legacy)|||||||0.064|||||||van Elteren nonparametric test|Adjusted for center|||
1747753|NCT00380250|3211728|Superiority or Other (legacy)|||||||0.348|||||||van Elteren nonparametric test|Adjusted for center|||
1747754|NCT00380250|3211729|Superiority or Other (legacy)|||||||0.049|||||||van Elteren nonparametric test|Adjusted for center|||
1747755|NCT00380250|3211730|Superiority or Other (legacy)|||||||0.13|||||||van Elteren nonparametric test|Adjusted for center|||
1747756|NCT00380250|3211731|Superiority or Other (legacy)|||||||0.03|||||||van Elteren nonparametric test|Adjusted for center|||
1747757|NCT00380250|3211732|Superiority or Other (legacy)|||||||0.242|||||||van Elteren nonparametric test|Adjusted for center|||
1747758|NCT00380250|3211733|Superiority or Other (legacy)|||||||0.334|||||||van Elteren nonparametric test|Adjusted for center|||
1747759|NCT00380250|3211734|Superiority or Other (legacy)|||||||0.337|||||||van Elteren nonparametric test|Adjusted for center|||
1747760|NCT00380250|3211735|Superiority or Other (legacy)|||||||0.286|||||||van Elteren nonparametric test|Adjusted for center|||
1747761|NCT00380250|3211736|Superiority or Other (legacy)|||||||0.098||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality|||
1747762|NCT00380250|3211737|Superiority or Other (legacy)|||||||0.069||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality|||
1747763|NCT00380250|3211738|Superiority or Other (legacy)|||||||0.028||||||Sequential closed testing procedures were employed|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality|||
1747764|NCT00380250|3211739|Superiority or Other (legacy)|||||||0.029||||||No adjustment|Cochran-Mantel-Haenszel|Stratified by pooled center, used to test the null hypothesis of equal rates between the 2 groups vs. the alternate hypothesis of non-equality||90% statistical power to detect 70.6% improvement in response with lubiprostone|
1747765|NCT00380250|3211740|Superiority or Other (legacy)|||||||0.588|||||||ANCOVA|Adjusted for clinical site|||
1747766|NCT00380250|3211741|Superiority or Other (legacy)|||||||0.378|||||||Cochran-Mantel-Haenszel|Stratified by pooled center|||
1747767|NCT00380250|3211742|Superiority or Other (legacy)|||||||0.159|||||||van Elteren nonparametric test|Adjusted for center|||
1747768|NCT00380250|3211743|Superiority or Other (legacy)|||||||0.05|||||||van Elteren nonparametric test|Adjusted for center|||
1747769|NCT00380250|3211744|Superiority or Other (legacy)|||||||0.006|||||||van Elteren nonparametric test|Adjusted for center|||
1747770|NCT00380250|3211745|Superiority or Other (legacy)|||||||0.117|||||||van Elteren nonparametric test|Adjusted for center|||
1747771|NCT00380081|3211746|Superiority or Other|||||||0.017||||||Treatment effect|ANCOVA||||
1747772|NCT00380081|3211747|Superiority or Other||||||<|0.001||||||Period effect|ANCOVA||||
1747773|NCT00380081|3211747|Superiority or Other||||||<|0.072||||||Treatment effect|ANCOVA||||
1747774|NCT00380081|3211748|Superiority or Other|||||||0.083||||||Treatment effect|ANCOVA||||
1747780|NCT00380081|3211754|Superiority or Other||||||<|0.001||||||Treatment effect|Cochran-Mantel-Haenszel|||The outcome noted above reflects the all-night sleep quality rating of study subjects who had a scheduled awakening after approximately 4 hours of sleep, were kept awake for 30 minutes and then allowed to return to bed and to sleep. After 4 hours, they were awakened again and disconnected from the PSG apparatus. Morning testing was conducted that included the Sleep Quality questionnaire. Evaluation of the results should reflect the nature of the study and the scheduled sleep disturbance.|
1747781|NCT00380081|3211755|Superiority or Other||||||<|0.001||||||Treatment effect|ANCOVA||||
1747782|NCT00380081|3211756|Superiority or Other||||||<|0.001||||||Treatment effect|ANCOVA||||
1747783|NCT00380081|3211757|Superiority or Other||||||<|0.001||||||Treatment effect|ANCOVA||||
1747784|NCT00380081|3211758|Superiority or Other||||||<|0.001||||||Treatment effect|ANCOVA||||
1747785|NCT00380081|3211759|Superiority or Other||||||<|0.001||||||Treatment effect|Cochran-Mantel-Haenszel||||
1747786|NCT00380081|3211760|Superiority or Other||||||<|0.001||||||Treatment effect|ANCOVA||||
1747787|NCT00380068|3211761|Superiority or Other||percent event free|95.3||||||95.0|91.2|97.6|||||Estimate obtained through Kaplan-Meier methods||
1747788|NCT00380068|3211762|Superiority or Other||percent event free|97.1||||||95.0|93.6|98.7|||||Estimate obtained through Kaplan-Meier methods||
1747789|NCT00380068|3211763|Superiority or Other||percent event free|90.0||||||95.0|81.6|94.7|||||Estimate obtained through Kaplan-Meier methods||
1747790|NCT00380068|3211764|Superiority or Other||percent event free|95.0||||||95.0|88.5|97.9|||||Estimate obtained through Kaplan-Meier methods||
1747791|NCT00380068|3211765|Superiority or Other||percent event free|92.9||||||95.0|88.3|95.8|||||Estimate obtained through Kaplan-Meier methods||
1747792|NCT00380068|3211766|Superiority or Other||percent event free|95.3||||||95.0|91.4|97.4|||||Estimate obtained through Kaplan-Meier methods||
1747793|NCT00380068|3211767|Superiority or Other||percent event free|84.1||||||95.0|78.2|88.6|||||Estimate obtained through Kaplan-Meier methods||
1747794|NCT00380068|3211768|Superiority or Other||percent event free|89.4||||||95.0|84.4|92.8|||||Estimate obtained through Kaplan-Meier methods||
1747795|NCT00380068|3211769|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|Paired t-test on change from Baseline to Week 48|||
1747796|NCT00380068|3211770|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|Paired t-test on change from Baseline to Week 24|||
1747797|NCT00380068|3211771|Superiority or Other||||||<|0.001||||||Statistical test performed on actual change from baseline WHO functional Class (eg, a change from WHO Class III to II is -1; a change from WHO Class IV to II is -2; etc).|Wilcoxon signed-rank test||||
1747798|NCT00380068|3211772|Superiority or Other||||||<|0.001||||||Statistical test performed on actual change from baseline WHO functional Class (eg, a change from WHO Class III to II is -1; a change from WHO Class IV to II is -2; etc).|Wilcoxon signed-rank test||||
1747799|NCT00380068|3211773|Superiority or Other||Percent change from baseline|-29.2||||||95.0|-39.8|-16.6|||||Percent change from baseline derived from Geometric Mean Ratio||
1747800|NCT00380068|3211774|Superiority or Other||Percent change from baseline|-25.5||||||95.0|-33.6|-16.3|||||Percent change from baseline derived from Geometric Mean Ratio||
1747801|NCT00380068|3211775|Superiority or Other||Mean Difference (Net)|-0.6||||0.001||95.0|-1.0|-0.2|||t-test, 2 sided|Paired t-test on change from Baseline to Week 48|||
1747802|NCT00380068|3211776|Superiority or Other||Mean Difference (Net)|-0.5|Standard Deviation|2.11|<|0.001||95.0|-0.8|-0.3|||t-test, 2 sided|Paired t-test on change from Baseline to Week 24|||
1747803|NCT00380068|3211777|Superiority or Other||Mean Difference (Net)|20.5|Standard Deviation|65.64|<|0.001||95.0|11.8|29.3|||t-test, 2 sided|Paired t-test on change from Baseline to Week 24|||
1747804|NCT00379899|3211791|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor|||
1747805|NCT00379899|3211792|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor|||
1747806|NCT00379899|3211793|Superiority or Other|||||||0.021|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor|||
1747807|NCT00379899|3211794|Superiority or Other|||||||0.025|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor|||
1747808|NCT00379899|3211795|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor|||
1747809|NCT00379899|3211796|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor|||
1747810|NCT00379899|3211797|Superiority or Other|||||||0.011|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor|||
1747811|NCT00379899|3211798|Superiority or Other|||||||0.258|||||||Cochran-Mantel-Haenszel||||
1747812|NCT00379899|3211800|Superiority or Other|||||||0.018|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor|||
1747813|NCT00379899|3211801|Superiority or Other||Odds Ratio (OR)|0.62||||0.094||95.0|0.36|1.08|||Cochran-Mantel-Haenszel||Logit estimates (Cinacalcet:Control)||
1747814|NCT00379899|3211802|Superiority or Other|||||||0.073|||||||Cochran-Mantel-Haenszel|Adjusted for screening total coronary artery calcification score stratification factor (≥ 30 to 399, ≥ 400 to 999, and ≥ 1000)|||
1747815|NCT00379821|3211807|Superiority or Other||Hazard Ratio (HR)|0.96|Standard Error of the Mean|0.17||0.79|2-Sided|95.0|0.68|1.34||Not adjusted, 0.05|Regression, Cox|There are no adjustments.|The reference category is those who did not travel.||
1747816|NCT00379821|3211841|Superiority or Other||Risk Ratio (RR)|1.0707|Standard Error of the Mean|0.1795||0.6277|2-Sided|95.0|0.7708|1.4872||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments.|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.|
1748002|NCT00377364|3212144|Superiority or Other||||||<|0.05|||||||ANCOVA|||Baseline HRSD scores used as a covariate.|
1747817|NCT00379821|3211841|Superiority or Other||Risk Ratio (RR)|1.1623|Standard Error of the Mean|0.1973||0.3767|2-Sided|95.0|0.8333|1.6211||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments.|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.|
1747818|NCT00379821|3211841|Superiority or Other||Risk Ratio (RR)|1.0413|Standard Error of the Mean|0.1746||0.8097|2-Sided|95.0|0.7497|1.4463||The a priori threshold for statistical significance is 0.05/3.|Poisson regression|No adjustments|The denominator for the risk ratio is the CQ Monotherapy arm.|Number of clinical malaria episodes per PYAR was compared using Poisson regression assuming null hypothesis that the number of malaria episodes are the same in both groups.|
1747819|NCT00379808|3211842|Superiority or Other||percent difference|16.5||||0.09|||||||wilcoxon sign rank|||null hypothesis is that montelukast does not affect ENA-78. The study is not powered to this biomarker|
1747820|NCT00379808|3211843|Superiority or Other||percent difference|13.3||||0.03|||||||wilcoxon sign rank test|||null hypothesis is that montelukast does not affect IL1ra.|
1747821|NCT00379808|3211844|Superiority or Other||percent difference|11.9||||0.12|||||||Wilcoxon|||null hypothesis is that montelukast does not affect MCP-1. Study not powered to the biomarker.|
1747822|NCT00379808|3211845|Superiority or Other||percent difference|7.4||||0.33|||||||wilcoxon sign rank|||The null hypothesis is that montelukast does not affect triglycerides. The study was not powered to this outcome measure.|
1747823|NCT00379808|3211846|Superiority or Other||percent difference|3.8||||0.57|||||||Wilcoxon sign rank|||Null hypothesis is that montelukast does not affect HDL. Not powered for this endpoint|
1747824|NCT00379808|3211847|Superiority or Other||Median Difference (Net)|0.0||||0.22|||||||Wilcoxon sign rank test|||Statistical power was calculated using G*Power (Dusseldorf, Germany). Based on previously observed effects of statin drugs on hsCRP levels, 22 subjects provided 80% power to detect a moderate effect on hsCRP levels.|
1747825|NCT00379769|3211873|Superiority or Other||Hazard Ratio (HR)|0.82||||||95.0|0.57|1.18|||||||
1747826|NCT00379769|3211874|Superiority or Other||Hazard Ratio (HR)|0.79||||||95.0|0.54|1.14|||||||
1747827|NCT00379769|3211875|Superiority or Other||Hazard Ratio (HR)|1.15||||||95.0|0.82|1.62|||||||
1747828|NCT00379769|3211876|Superiority or Other||Hazard Ratio (HR)|1.13||||||95.0|0.8|1.59|||||||
1747829|NCT00379769|3211877|Superiority or Other||Hazard Ratio (HR)|0.9||||||95.0|0.68|1.21|||||||
1747830|NCT00379769|3211878|Superiority or Other||Hazard Ratio (HR)|0.9||||||95.0|0.68|1.21|||||||
1747831|NCT00379769|3211879|Superiority or Other||Hazard Ratio (HR)|0.97||||||95.0|0.79|1.18|||||||
1747832|NCT00379769|3211880|Superiority or Other||Hazard Ratio (HR)|0.95||||||95.0|0.78|1.17|||||||
1747833|NCT00379769|3211881|Superiority or Other||Hazard Ratio (HR)|0.86||||||95.0|0.68|1.08|||||||
1747834|NCT00379769|3211905|Non-Inferiority or Equivalence|Non-inferiority margin of 1.2 for the upper limit of the 95 percent confidence interval in time to event analysis comparing RSG to MET/SU stratified by background medication|Hazard Ratio (HR)|0.99||||||95.0|0.85|1.16|||||||
1747835|NCT00379288|3211927|Superiority or Other||percentage of subjects with serious AEs|3.1||||||95.0|||||||||
1747836|NCT00379288|3211927|Superiority or Other||percentage of subjects with severe AEs|6.2||||||95.0|||||||||
1747837|NCT00379288|3211927|Superiority or Other||percentage of subjects with related AEs|20.0||||||95.0|||||||||
1747838|NCT00379288|3211927|Superiority or Other||percentage of subjects with TEAEs|76.9||||||95.0|||||||||
1747839|NCT00379288|3211927|Superiority or Other||percentage of subjects with serious AEs|5.8||||||95.0|||||||||
1747840|NCT00379288|3211927|Superiority or Other||percentage of subjects with severe AEs|5.9||||||95.0|||||||||
1747841|NCT00379288|3211927|Superiority or Other||percentage of subjects with related AEs|23.5||||||95.0|||||||||
1747842|NCT00379288|3211927|Superiority or Other||percentage of subjects with TEAEs|82.4||||||95.0|||||||||
1747843|NCT00379288|3211927|Superiority or Other||percentage of subjects with serious AEs|6.1||||||95.0|||||||||
1747844|NCT00379288|3211927|Superiority or Other||percentage of subjects with severe AEs|3.8||||||95.0|||||||||
1747845|NCT00379288|3211927|Superiority or Other||percentage of subjects with related AEs|23.1||||||95.0|||||||||
1747846|NCT00379288|3211927|Superiority or Other||percentage of subjects with TEAEs|79.2||||||95.0|||||||||
1747847|NCT00379288|3211927|Superiority or Other||percentage of subjects with serious AEs|4.9||||||95.0|||||||||
1747848|NCT00379288|3211927|Superiority or Other||percentage of subjects with severe AEs|5.7||||||95.0|||||||||
1747849|NCT00379288|3211927|Superiority or Other||percentage of subjects with related AEs|28.4||||||95.0|||||||||
1747850|NCT00379288|3211927|Superiority or Other||percentage of subjects with TEAEs|77.4||||||95.0|||||||||
1747851|NCT00379236|3211932|Superiority or Other|||||||0.006|||||||Chi-squared||||
1747852|NCT00379236|3211943|Superiority or Other|||||||0.002|||||||ANCOVA|Baseline pain score was the covariate; study center was modeled as a random effect while all other variables were modeled as fixed effects.|||
1747853|NCT00379236|3211944|Superiority or Other|||||||0.028|||||||Chi-squared||||
1747854|NCT00379236|3211945|Superiority or Other|||||||0.618|||||||Chi-squared||||
1747855|NCT00379236|3211946|Superiority or Other|||||||0.047|||||||Chi-squared||||
1747856|NCT00379236|3211947|Superiority or Other|||||||0.202|||||||Chi-squared||||
1747857|NCT00379236|3211948|Superiority or Other|||||||0.001||||||P-value is purely nominal|ANCOVA||||
1747858|NCT00379236|3211949|Superiority or Other|||||||0.008|||||||ANCOVA|Screening pain score was the covariate; study center was modeled as a random effect while all other variables were modeled as fixed effects.|||
1747859|NCT00379210|3211951|Superiority or Other||||||<|0.01|||||||ANOVA|||Statistical tests are evaluated at an alpha level of 0.05 (corrected, when appropriate, for multiple comparisons). Analyses are performed on both response latency and accuracy on behavioral data. For latency analyses, mean response times for correct trials are calculated for each subject. Repeated-measures ANOVA are used for omnibus tests; paired t-tests are used for individual planned contrasts, with Bonferroni-corrected significance levels to maintain a .05 alpha level|
1747867|NCT00378703|3211973|Superiority or Other|||||||0.3006||||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.|
1747868|NCT00378703|3211973|Superiority or Other|||||||0.0085||||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.|
1747869|NCT00378703|3211973|Superiority or Other|||||||0.0076||||||Each combination arm was compared with the bevacizumab alone arm. Since there were 3 pairwise comparisons, a Bonferroni--adjusted p-value of 0.017 was considered to be statistically significant.|Fisher Exact|||The response rate of each combination arm was compared to that of the bevacizumab alone arm.|
1747870|NCT00378703|3211976|Superiority or Other|||||||0.68|||||||Log Rank|||Progression-free survival was compared between Arm D (sorafenib and temsirolimus) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk).|
1747871|NCT00378703|3211976|Superiority or Other|||||||0.54|||||||Log Rank|||Progression-free survival was compared between Arm C (bevacizumab and sorafenib) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk).|
1747872|NCT00378703|3211976|Superiority or Other|||||||0.89|||||||Log Rank|||Progression-free survival was compared between Arm B (bevacizumab and temsirolimus) and Arm A (bevacizumab alone) using stratified log rank test, stratified on prior cytokine or vaccine therapy and risk category (low/intermediate/high risk)|
1747873|NCT00378599|3211977|Superiority or Other||Binomial Approximation|0.288|||||2-Sided|95.0|0.21|0.38|||||||
1747874|NCT00378560|3211981|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1747875|NCT00378560|3211982|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1747876|NCT00378560|3211983|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1747877|NCT00378560|3211984|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1747878|NCT00378560|3211985|Superiority or Other||Percent Relative Risk Reduction|87.6|||||2-Sided|95.0|59.2|97.6|||||Binomial probability conditional on the fixed number of events.||
1747879|NCT00378378|3211994|Superiority or Other|||||||0.193|||||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.|
1747880|NCT00378378|3211994|Superiority or Other|||||||0.603|||||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.|
1747881|NCT00378378|3211994|Superiority or Other|||||||0.361|||||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint|
1747882|NCT00378378|3211995|Superiority or Other|||||||0.194|||||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.|
1747883|NCT00378378|3211995|Superiority or Other|||||||0.735|||||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.|
1747884|NCT00378378|3211995|Superiority or Other|||||||0.258|||||||ANOVA|||Pairwise comparison p-values were based on a two-way ANOVA for the change from basline|
1747885|NCT00377858|3212044|Superiority or Other||Mean Difference (Net)|-0.09||||0.803||95.0|-0.8|0.62||P-value for Change from Baseline.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Sulfonylurea stratum + Country + Baseline HbA1c stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747886|NCT00377858|3212045|Superiority or Other||Mean Difference (Net)|0.19||||0.011||95.0|0.04|0.34||P-value for Endpoint. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747887|NCT00377858|3212045|Superiority or Other||Mean Difference (Net)|0.22||||0.005||95.0|0.07|0.38||P-value for Week 36.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747888|NCT00377858|3212045|Superiority or Other||Mean Difference (Net)|0.24||||0.002||95.0|0.09|0.4||P-value for Week 30.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747889|NCT00377858|3212045|Superiority or Other||Mean Difference (Net)|0.22||||0.003||95.0|0.07|0.36||P-value for Week 24.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747890|NCT00377858|3212045|Superiority or Other||Mean Difference (Net)|0.33|||<|0.001||95.0|0.24|0.42||P-value for Week 12.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747891|NCT00377858|3212046|Superiority or Other||Mean Difference (Net)|5.2||||0.017||95.0|0.93|9.46||P-value for Daily Total.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747892|NCT00377858|3212046|Superiority or Other||Mean Difference (Net)|6.05|||<|0.001||95.0|3.39|8.71||P-value for Daily Prandial.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1748003|NCT00377364|3212145|Superiority or Other||||||<|0.05|||||||ANCOVA|Baseline ISS scores used as a covariate. ANCOVA results were not significant.|||
1748004|NCT00377364|3212148|Superiority or Other||||||<|0.05|||||||ANCOVA|||Baseline RAVLT scores used as covariate.|
1747893|NCT00377858|3212046|Superiority or Other||Mean Difference (Net)|-6.96|||<|0.001||95.0|-9.65|-4.26||P-value for Daily Basal.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747894|NCT00377858|3212047|Superiority or Other||Mean Difference (Net)|0.07||||0.017||95.0|0.01|0.12||P-value for Daily Total.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747895|NCT00377858|3212047|Superiority or Other||Mean Difference (Net)|0.07|||<|0.001||95.0|0.04|0.11||P-value for Daily Prandial.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747896|NCT00377858|3212047|Superiority or Other||Mean Difference (Net)|-0.08|||<|0.001||95.0|-0.12|-0.05||P-value for Daily Basal.|ANCOVA|ANCOVA Model: Variable=Treatment + Country + Baseline HbA1c stratum + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747897|NCT00377858|3212048|Superiority or Other|||||||0.416||||||P-value for Overall Severe Hypoglycemic Episodes.|Fisher Exact||||
1747898|NCT00377858|3212049|Superiority or Other|||||||0.255||||||P-value for Overall Non-Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.|||
1747899|NCT00377858|3212049|Superiority or Other|||||||0.018||||||P-value for Endpoint Non-Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.|||
1747900|NCT00377858|3212049|Superiority or Other|||||||0.615||||||P-value for Overall Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.|||
1747901|NCT00377858|3212049|Superiority or Other|||||||0.311||||||P-value for Endpoint Nocturnal Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.|||
1747902|NCT00377858|3212049|Superiority or Other|||||||0.218||||||P-value for Overall Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.|||
1747903|NCT00377858|3212049|Superiority or Other|||||||0.022||||||P-value for Endpoint Hypoglycemic Rate.|ANOVA|ANOVA Model: Rank of Variable = Treatment + Sufonylurea Stratum + Country + Baseline HbA1c Stratum.|||
1747904|NCT00377858|3212050|Superiority or Other|||||||0.756||||||P-value for Overall Non-Nocturnal Hypoglycemic Episodes.|Fisher Exact||||
1747905|NCT00377858|3212050|Superiority or Other|||||||0.013||||||P-value for Endpoint Non-Nocturnal Hypoglycemic Episodes.|Fisher Exact||||
1747906|NCT00377858|3212050|Superiority or Other|||||||1||||||P-value for Overall Nocturnal Hypoglycemic Episodes.|Fisher Exact||||
1747907|NCT00377858|3212050|Superiority or Other|||||||0.43||||||P-value for Endpoint Nocturnal Hypoglycemic Episodes.|Fisher Exact||||
1747908|NCT00377858|3212050|Superiority or Other|||||||1||||||P-value for Overall Hypoglycemic Episodes.|Fisher Exact||||
1747909|NCT00377858|3212050|Superiority or Other|||||||0.094||||||P-value for Endpoint Hypoglycemic Episodes.|Fisher Exact||||
1747910|NCT00377858|3212051|Superiority or Other||Mean Difference (Net)|-1.72||||0.362||95.0|-5.44|1.99||P-value for Endpoint M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747911|NCT00377858|3212051|Superiority or Other||Mean Difference (Net)|-0.09||||0.25||95.0|-0.26|0.07||P-value for Endpoint MODD. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747912|NCT00377858|3212051|Superiority or Other||Mean Difference (Net)|-0.95||||0.629||95.0|-4.79|2.9||P-value for 36 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747913|NCT00377858|3212051|Superiority or Other||Mean Difference (Net)|-0.05||||0.573||95.0|-0.22|0.12||P-value for 36 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747914|NCT00377858|3212051|Superiority or Other||Mean Difference (Net)|2.52||||0.179||95.0|-1.16|6.21||P-value for 24 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747915|NCT00377858|3212051|Superiority or Other||Mean Difference (Net)|-0.09||||0.321||95.0|-0.26|0.09||P-value for 24 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747916|NCT00377858|3212051|Superiority or Other||Mean Difference (Net)|1.58||||0.4||95.0|-2.11|5.27||P-value for 12 Week M-Value.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747917|NCT00377858|3212051|Superiority or Other||Mean Difference (Net)|-0.03||||0.701||95.0|-0.19|0.13||P-value for 12 Week MODD.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1748021|NCT00377299|3212165|Superiority or Other||||||>|0.05||||||Significance was set at a p value of ≤ 0.05.|ANCOVA||||
1747918|NCT00377858|3212051|Superiority or Other||Mean Difference (Net)|1.27||||0.737||95.0|-6.14|8.68||P-value for Baseline M-Value.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747919|NCT00377858|3212051|Superiority or Other||Mean Difference (Net)|0.02||||0.776||95.0|-0.14|0.19||P-value for Baseline MODD.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747920|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|-0.12||||0.569||95.0|-0.51|0.28||P-value for Endpoint: 0300 Hours. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747921|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|-0.57||||0.009||95.0|-1.0|-0.14||P-value for Endpoint: Evening Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747922|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.17||||0.427||95.0|-0.24|0.57||P-value for Endpoint: Evening Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747923|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|-0.06||||0.814||95.0|-0.52|0.41||P-value for Endpoint: Midday Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747924|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|-0.16||||0.43||95.0|-0.57|0.24||P-value for Endpoint: Midday Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747925|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|-0.31||||0.201||95.0|-0.8|0.17||P-value for Endpoint: Morning Postprandial Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747926|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.45||||0.01||95.0|0.11|0.8||P-value for Endpoint: Morning Pre-Meal. (last observation carried forward)|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747927|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|-0.07||||0.77||95.0|-0.51|0.37||P-value for 36 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747928|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|-0.39||||0.096||95.0|-0.84|0.07||P-value for 36 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747929|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.16||||0.453||95.0|-0.27|0.6||P-value for 36 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747930|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.01||||0.964||95.0|-0.5|0.52||P-value for 36 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747931|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|-0.13||||0.548||95.0|-0.54|0.29||P-value for 36 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747932|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|-0.2||||0.438||95.0|-0.71|0.31||P-value for 36 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747933|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.49||||0.008||95.0|0.13|0.85||P-value for 36 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747934|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|-0.05||||0.816||95.0|-0.45|0.35||P-value for 24 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1748022|NCT00377299|3212166|Superiority or Other||||||>|0.05||||||Significance was set at a p value of ≤ 0.05.|ANCOVA||||
1747935|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|-0.48||||0.029||95.0|-0.92|-0.05||P-value for 24 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747936|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.56||||0.01||95.0|0.13|0.98||P-value for 24 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747937|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.23||||0.351||95.0|-0.25|0.71||P-value for 24 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747938|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.17||||0.408||95.0|-0.24|0.59||P-value for 24 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747939|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.42||||0.094||95.0|-0.07|0.91||P-value for 24 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747940|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.65|||<|0.001||95.0|0.31|0.99||P-value for 24 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747941|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|-0.15|||<|0.506||95.0|-0.59|0.29||P-value for 12 Week: 0300 Hours.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747942|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|-1.17|||<|0.001||95.0|-1.63|-0.7||P-value for 12 Week: Evening Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747943|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.77|||<|0.001||95.0|0.35|1.18||P-value for 12 Week: Evening Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747944|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.49|||<|0.049||95.0|0.0|0.97||P-value for 12 Week: Midday Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747945|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.53|||<|0.009||95.0|0.14|0.93||P-value for 12 Week: Midday Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747946|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.28|||<|0.278||95.0|-0.22|0.78||P-value for 12 Week: Morning Postprandial Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747947|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.59|||<|0.001||95.0|0.26|0.92||P-value for 12 Week: Morning Pre-Meal.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747948|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.2|||<|0.499||95.0|-0.38|0.77||P-value for Baseline: 0300 Hours.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747949|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.11|||<|0.693||95.0|-0.43|0.64||P-value for Baseline: Evening Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747950|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.07|||<|0.793||95.0|-0.48|0.62||P-value for Baseline: Evening Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747951|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.18|||<|0.536||95.0|-0.39|0.75||P-value for Baseline: Midday Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747952|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.54|||<|0.051||95.0|0.0|1.08||P-value for Baseline: Midday Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747953|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.11|||<|0.735||95.0|-0.51|0.72||P-value for Baseline: Morning Postprandial Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747954|NCT00377858|3212052|Superiority or Other||Mean Difference (Net)|0.58|||<|0.014||95.0|0.12|1.04||P-value for Baseline: Morning Pre-Meal.|ANOVA|ANOVA Model: Variable=Treatment + Baseline HbA1c stratum + Country + Sulfonylurea stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747955|NCT00377858|3212053|Superiority or Other|||||||0.108||||||P-value for Endpoint (LOCF): HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.|||
1747956|NCT00377858|3212053|Superiority or Other|||||||0.482||||||P-value for Endpoint (LOCF): HbA1c <7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.|||
1747957|NCT00377858|3212053|Superiority or Other|||||||0.227||||||P-value for Endpoint (LOCF): HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.|||
1747958|NCT00377858|3212053|Superiority or Other|||||||0.396||||||P-value for 36 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.|||
1747959|NCT00377858|3212053|Superiority or Other|||||||0.739||||||P-value for 36 Week: HbA1c <7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.|||
1747960|NCT00377858|3212053|Superiority or Other|||||||0.393||||||P-value for 36 Week: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.|||
1747961|NCT00377858|3212053|Superiority or Other|||||||0.185||||||P-value for 24 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.|||
1747962|NCT00377858|3212053|Superiority or Other|||||||0.636||||||P-value for 24 Week: HbA1c <7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.|||
1747963|NCT00377858|3212053|Superiority or Other|||||||0.198||||||P-value for 24 Week: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.|||
1747964|NCT00377858|3212053|Superiority or Other|||||||0.37||||||P-value for 12 Week: HbA1c ≤6.5%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.|||
1747965|NCT00377858|3212053|Superiority or Other|||||||0.602||||||P-value for 12 Week: HbA1c <7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.|||
1747966|NCT00377858|3212053|Superiority or Other|||||||0.432||||||P-value for Week 12: HbA1c ≤7.0%.|Regression, Logistic|Logistic Regression Model: Variable=Treatment + Baseline HbA1c + Country + Sulfonylurea Stratum.|||
1747967|NCT00377858|3212054|Superiority or Other||Mean Difference (Net)|0.1||||0.343||95.0|-0.1|0.29||P-value for 36 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747968|NCT00377858|3212054|Superiority or Other||Mean Difference (Net)|0.18||||0.043||95.0|0.01|0.35||P-value for 24 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747969|NCT00377858|3212054|Superiority or Other||Mean Difference (Net)|0.16||||0.047||95.0|0.0|0.33||P-value for 12 Week Interval.|ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c + Baseline HbA1c stratum + Sulfonylurea stratum + Country.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for Insulin Lispro Mid Mix minus Insulin Glargine.||
1747970|NCT00377858|3212055|Non-Inferiority or Equivalence|Noninferiority margin of 0.3% based on prior studies indicating an HbA1c difference of 0.6% in patients treated with lispro and sulfonylurea compared with those treated with sulfonylurea and metformin.|Mean Difference (Net)|0.17||||0.097||95.0|-0.03|0.37|||ANCOVA|ANCOVA Model: Variable=Treatment + Baseline HbA1c Stratum + Sulfonylurea stratum + Country + Baseline HbA1c Stratum.|The two-sided 95% confidence interval of the Least Squares Mean difference between the two treatments is for (Insulin Lispro Mid Mixture minus Insulin Glargine).|Assuming 15% drop-out rate after randomization, remaining 213 patients in each treatment group would allow confirmation of noninferiority with no treatment difference and a noninferiority limit of 0.3% using upper limit of 2-sided confidence interval at significance level of 0.05 with 80% power.|
1747971|NCT00377819|3212064|Superiority or Other||||||<|0.0001|||||||Van Elteren Stratified Rank Test||||
1747972|NCT00377819|3212065|Non-Inferiority or Equivalence|Non-inferiority margin = -0.22%|Mean Difference (Final Values)|1.18|||<|0.0001||95.0|0.63|1.73|||Repeated Measures Model||Based on repeated measures model adjusting for treatment, length of prior alendronate stratification variable, visit, baseline value, machine type, treatment by visit interaction, and baseline value by machine type interaction||
1747973|NCT00377819|3212066|Non-Inferiority or Equivalence|Non-inferiority margin = -0.35%|Mean Difference (Final Values)|0.85|||<|0.0001||95.0|0.44|1.25|||Repeated Measures Model||Based on repeated measures model adjusting for treatment, length of prior alendronate stratification variable, visit, baseline value, machine type, treatment by visit interaction, and baseline value by machine type interaction||
1747974|NCT00377741|3212070|Superiority or Other||Mean exposure ratio for Cmax|1.12|||||2-Sided|90.0|0.88|1.42|||||||
1747975|NCT00377741|3212071|Superiority or Other||Mean exposure ratio for AUC(0-tau)|1.24|||||2-Sided|90.0|0.98|1.55|||||||
1747976|NCT00377676|3212072|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.001|||||||ANOVA||||
1748023|NCT00377299|3212167|Superiority or Other|||||||0.05||||||Significance was set at a p value of ≤ 0.05.|ANCOVA||||
1748066|NCT00377156|3212199|Superiority or Other (legacy)||Mean Difference (Final Values)|11.9||||0.001|2-Sided|95.0|4.8|19.0|||t-test, 2 sided||||
1747977|NCT00377676|3212073|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Deviation|1.4|<|0.001|||||||ANOVA|||If the standard deviation of HbA1c level is about 1.0% and the baseline and 24 week scores have a correlation of 0.50 then the effect size is 0.5%/1.0% = 0.50. For the metformin/SU analysis, 160 subjects assuming a standard deviation of 1.0% would provide a power of 90% power to detect differences in mean changes of 0.5% or larger.|
1747978|NCT00377676|3212074|Superiority or Other||Cox Proportional Hazard|0.58|||<|0.05|2-Sided|95.0|0.35|0.96|||Regression, Cox|||In order to test the hypothesis for serious cardiovascular adverse events as for the primary endpoint at a one-sided alpha = 0.5 when the non-inferiority margin is 1.5, the final sample size of 3000 to 3300 subjects was to provide at least 62% power, assuming a hypothetical rate of events of 3.43%, or 103 to 113 cardiovascular SAEs. Upon demonstration of non-inferiority - a 2 sided using 95% CI was used to assess for superiority.|
1747979|NCT00377676|3212075|Non-Inferiority or Equivalence|In order to test the primary hypothesis at a one-sided alpha = .05 and have a power of 0.9, when the non-inferiority margin is 1.5, the total number of subjects with all-cause SAEs that must be observed during the study was found to be 235. Assuming the placebo rate is 0.08, the required sample size was found to be 2991.|Hazard Ratio (HR)|1.02|||<|0.05|1-Sided|95.0||1.27||Using the Lan and Demets alpha spending function for O’Brien-Fleming boundaries and the overall one-sided significance level of 5%, a level of 0.04068 was to be used at the interim analysis and 0.03938 at the time of the final analysis.|Regression, Cox||cycloset to placebo||
1747980|NCT00377637|3212088|Superiority or Other|||||||0.003||||||Testing at the alpha=0.05 level was applied with no adjustments made for multiplicity.|Log Rank|||The difference in Kaplan-Meier survival curves between treatment groups (MMF−AZA) was assessed using a log-rank test, which is a non-parametric test to compare the survival distributions of two groups commonly used to analyze time-to-event endpoints.|
1747981|NCT00377637|3212089|Superiority or Other|||||||0.478|||||||Regression, Logistic|Covariates included Treatment, Race, Geographical Region, and WHO Lupus Nephritis Class V and specified interaction terms.|||
1747982|NCT00377572|3212109|Superiority or Other|||||||0.58|||||||Wilcoxon (Mann-Whitney)||||
1747983|NCT00377572|3212110|Superiority or Other|||||||0.84|||||||Wilcoxon (Mann-Whitney)||||
1747984|NCT00377572|3212111|Superiority or Other||||||<|0.001|||||||Regression, Logistic|Exacerbations were summed over the course of the double-blind and analyzed with an LR of ‘any’ versus ‘none’. LR adjusted for study site and dosing.|||
1747985|NCT00377572|3212112|Superiority or Other|||||||0.02|||||||Regression, Logistic|Hospitalizations were summed over the course of the double-blind & analyzed with logistic regression (LR) of ‘any’ vs. ‘none’. The LR was unadjusted.|||
1747986|NCT00377572|3212113|Superiority or Other|||||||0.003|||||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Comparison percent prescribed long-acting beta 2 agonists|
1747987|NCT00377572|3212114|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Inhaled glucocorticoids prescribed — mcg per day comparison|
1747988|NCT00377572|3212115|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Step level 4 – 6 (severe asthma)percent comparison|
1747989|NCT00377572|3212116|Superiority or Other|||||||0.001|||||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Step level 1- 2 (mild asthma) Percent Comparison|
1747990|NCT00377572|3212117|Superiority or Other|||||||0.12|||||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Percent Adherence Comparison|
1747991|NCT00377572|3212118|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.|||
1747992|NCT00377572|3212119|Superiority or Other|||||||0.81|||||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||FEV1:FVC ×100 comparison|
1747993|NCT00377572|3212120|Superiority or Other|||||||0.3|||||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||FEV1 % of predicted value comparison|
1747994|NCT00377572|3212121|Superiority or Other|||||||0.54|||||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Asthma Control Test comparison|
1747995|NCT00377572|3212122|Superiority or Other|||||||0.007|||||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Childhood Asthma Control Test comparison|
1747996|NCT00377572|3212123|Superiority or Other|||||||0.1111|||||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept (to account for within-subject correlation) and visit and group as fixed effects.|||
1747997|NCT00377572|3212124|Superiority or Other|||||||0.04|||||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.|||
1747998|NCT00377572|3212125|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|Linear mixed-effects models w/ random intercept and slope (to account for within-subject correlation over time) and visit and group as fixed effects.||Maximum Symptom Day Comparison|
1747999|NCT00377403|3212139|Superiority or Other|||||||0.83||||||The a priori threshold for statistical significnace was p less than or equal to 0.05|ANOVA|Adjusted for disease severity at baseline||We used analysis of variance, controlling for disease severity at baseline to test the null hypothesis that there was no difference between study groups at this point in time.|
1748000|NCT00377364|3212140|Superiority or Other||||||<|0.05|||||||ANCOVA|Baseline ACQ scores used as a covariate.|||
1748001|NCT00377364|3212142|Superiority or Other|||||||0.05|||||||ANCOVA|Baseline YMRS scores used as a covariate.|||
1748005|NCT00377312|3212150|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05||||||the reported p-value corresponds to % change compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1748006|NCT00377312|3212151|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01||||||the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups|Mixed Models Analysis|the reported p-value corresponds to % change from baseline at the follow-up visit in all Arms/groups|||
1748007|NCT00377312|3212151|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001||||||the reported p-value corresponds to % decrease compared to baseline at Days 2-8 in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1748008|NCT00377312|3212152|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05||||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1748009|NCT00377312|3212152|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001||||||The reported p-value corresponds to % change (increase) from baseline in all Arms/groups at Days 2-8.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1748010|NCT00377312|3212153|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05||||||The reported p-value corresponds the the % change from baseline at follow-up in all Arms/groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1748011|NCT00377312|3212153|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.008||||||The reported p-value corresponds to the % increase compared to baseline in all Arms/groups on Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1748012|NCT00377312|3212154|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.61||||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1748013|NCT00377312|3212156|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.002||||||the reported p-value corresponds to the increase compared to baseline over time (days 2-8) in the PTH 2 pmol group|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1748014|NCT00377312|3212157|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.05||||||the reported p-values correspond to the decrease compared to baseline in all arms/groups at Days 2-8|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1748015|NCT00377312|3212158|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.||||||0.01||||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1748016|NCT00377312|3212159|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||>|0.05||||||The reported p-value corresponds to change over time for the PTH 2 and PTH 4 pmol groups|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1748017|NCT00377312|3212160|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001||||||The reported p-value corresponds to the increase over time for the PTH 2 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1748018|NCT00377312|3212161|Non-Inferiority or Equivalence|The study was designed as a standard dose-escalation study, dose-finding pilot study. The primary outcome measures were safety (hypercalcemia, hypophosphatemia and symptoms/hemodynamic measurements). A modified Fibronacci dose-escalation scheme was employed.|||||<|0.0001||||||The reported p-value corresponds to the increase over time for the PTH 2 pmol group.|Mixed Models Analysis|The level of statistical significance was set at .05 (two-tailed)|||
1748019|NCT00377299|3212163|Superiority or Other||||||>|0.05||||||Significance was set at a p value of ≤ 0.05.|ANCOVA||||
1748020|NCT00377299|3212164|Superiority or Other||||||>|0.05||||||Significance was set at a p value of ≤ 0.05.|ANCOVA||||
1748024|NCT00377260|3212168|Superiority or Other|||||||0.01|||||||Regression, Linear|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the mean weighted average acute otitis media - severity of symptom (AOM-SOS) score (symptom burden), post-enrollment, over the first 7 days of therapy.|
1748025|NCT00377260|3212169|Superiority or Other|||||||0.005|||||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the follow-visit visit.|
1748026|NCT00377260|3212170|Superiority or Other|||||||0.04|||||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the end-of-therapy visit.|
1748027|NCT00377260|3212171|Superiority or Other|||||||0.71|||||||Regression, Linear|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the groups regarding the mean parental satisfaction score at the on-therapy visit.|
1748028|NCT00377260|3212172|Superiority or Other|||||||0.66|||||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported making special daycare arrangements, i.e. number of such visits / total number of follow-up assessment visits.|
1748029|NCT00377260|3212173|Superiority or Other|||||||0.93|||||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the visits at which family member reported missing work, i.e. number of such visits / total number of follow-up assessment visits.|
1748030|NCT00377260|3212174|Superiority or Other||||||<|0.001|||||||Generalized estimating equations|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the number of antibiotic prescriptions, exclusive of the blinded study medication.|
1748031|NCT00377260|3212175|Superiority or Other||Hazard Ratio (HR)|1.37||||0.04||95.0|||||Regression, Cox|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.|The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.|Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score <=1 on two consecutive occasions.|
1748032|NCT00377260|3212176|Superiority or Other||Hazard Ratio (HR)|1.22||||0.14||95.0|||||Regression, Cox|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.|The Amoxicillin-Clavulanate arm represents the numerator and the Placebo arm represents the denominator.|Null hypothesis: There is no difference between the two groups regarding the time to resolution of symptoms where resolution is defined as AOM-SOS score <=1.|
1748033|NCT00377260|3212177|Superiority or Other|||||||0.9|||||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding visits to emergency room|
1748034|NCT00377260|3212178|Superiority or Other|||||||0.2|||||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding visits to primary care provider.|
1748035|NCT00377260|3212179|Superiority or Other|||||||0.04|||||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||The analysis was ITT. The number of participants equals the number of children for which at least one ear has an interpretable tympanogram at the follow-up visit.|
1748036|NCT00377260|3212180|Superiority or Other|||||||0.006|||||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the end-of-therapy visit.|
1748037|NCT00377260|3212181|Superiority or Other|||||||0.03|||||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the probability of middle ear effusion at the on-therapy visit.|
1748038|NCT00377260|3212182|Superiority or Other|||||||0.04|||||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.|
1748039|NCT00377260|3212183|Superiority or Other|||||||0.98|||||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.|
1748040|NCT00377260|3212183|Superiority or Other|||||||0.79|||||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.|
1748041|NCT00377260|3212183|Superiority or Other|||||||0.96|||||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.|
1748042|NCT00377260|3212183|Superiority or Other|||||||0.03|||||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.|
1748043|NCT00377260|3212183|Superiority or Other|||||||0.1|||||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.|
1748044|NCT00377260|3212184|Superiority or Other||||||<|0.001|||||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children colonized with penicillin-susceptible Streptococcus pneumoniae.|
1748045|NCT00377260|3212185|Superiority or Other|||||||0.28|||||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pyogenes present.|
1748046|NCT00377260|3212185|Superiority or Other||||||<|0.001|||||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Moraxella catarrhalis present.|
1748047|NCT00377260|3212185|Superiority or Other||||||<|0.85|||||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Haemophilus influenzae present.|
1748048|NCT00377260|3212185|Superiority or Other||||||<|0.001|||||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with Streptococcus pneumoniae present.|
1748049|NCT00377260|3212185|Superiority or Other||||||<|0.002|||||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of culture results with at least one AOM pathogen present.|
1748050|NCT00377260|3212186|Superiority or Other|||||||0.08|||||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with perforation of their tympanic membrane.|
1748051|NCT00377260|3212186|Superiority or Other|||||||0.99|||||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with mastoiditis.|
1748052|NCT00377260|3212186|Superiority or Other||||||>|0.99|||||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with rash.|
1748053|NCT00377260|3212186|Superiority or Other||||||>|0.99|||||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with vomiting.|
1748054|NCT00377260|3212186|Superiority or Other||||||>|0.07|||||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with oral thrush.|
1748055|NCT00377260|3212186|Superiority or Other||||||<|0.01|||||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with diaper dermatitis.|
1748056|NCT00377260|3212186|Superiority or Other||||||<|0.04|||||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two treatment groups regarding the proportion of children with protocol-defined diarrhea.|
1748057|NCT00377260|3212187|Superiority or Other|||||||0.35||||||A weighted regression model was used with weights equal to the number of days information regarding analgesic use was reported by the parents.|Regression, Linear|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the average number of doses of analgesic medication administered by parents.|
1748058|NCT00377260|3212188|Superiority or Other|||||||0.24|||||||Regression, Logistic|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of children who develop worsening symptoms within the first 3 days of treatment.|
1748059|NCT00377260|3212189|Superiority or Other|||||||0.02|||||||Generalized estimating equations|The comparison was adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the symptom burden as measured by the respective mean scores over time.|
1748060|NCT00377260|3212190|Superiority or Other||||||<|0.001|||||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of clinical failures by the end of therapy.|
1748061|NCT00377260|3212191|Superiority or Other||||||<|0.001|||||||Regression, Logistic|The comparison adjusted for site, history of recurrent acute otitis media and exposure to other children.||Null hypothesis: There is no difference between the two groups regarding the proportion of clinical treatment failures by the on-therapy visit.|
1748062|NCT00377234|3212196|Superiority or Other||||||<|0.0001||||||The reported p-values for the primary analysis test whether the overall preference rate for ibandronate equals 50%. Preference within each sequence is not tested.|Prescott Test||||
1748063|NCT00377234|3212196|Superiority or Other||||||<|0.0001||||||Null hypothesis: Preference rate (including patients not expressing treatment preference and considering order treatments were received) for monthly ibandronate = 50%. Null hypothesis is rejected if P-value was below significance threshold of P <0.05|Garts Test||||
1748064|NCT00377156|3212197|Superiority or Other (legacy)||Hazard Ratio (HR)|1.02||||0.92|2-Sided|95.0|0.75|1.38|||Regression, Cox||||
1748065|NCT00377156|3212198|Superiority or Other (legacy)||Mean Difference (Final Values)|-34.4||||0.04|2-Sided|95.0|-74.4|5.5|||Fisher Exact||The incidence of cognitive deterioration was less in Arm I than Arm II at 12 months (6/10 [60%] vs 17/18 [94.4%]. The percent difference was −34.4% (95% CI: −74.4% to 5.5%; P = .04)||
1748067|NCT00377156|3212200|Superiority or Other (legacy)||Difference in Percentage|-18.4|||<|0.001|2-Sided|95.0|-29.0|-7.8|||Fisher Exact||||
1748068|NCT00377156|3212201|Superiority or Other (legacy)||Difference in Percentage|-28.2|||<|0.001|2-Sided|90.0|-41.9|-14.4|||Fisher Exact||Cognitive deterioration, the primary end point in evaluable patients at 3 months, was less frequent after Arm I than Arm II (40/63 [63.5%] vs 44/48 [91.7%], > respectively. The percent difference was −28.2%; 90% CI, −41.9% to −14.4%; P < .001).||
1748069|NCT00376935|3212219|Superiority or Other||Shift parameter|-4.0||||0.3662|1-Sided|98.4||22.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (60 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (60 mcg/kg) arm.|
1748070|NCT00376935|3212219|Superiority or Other||Shift parameter|-4.0||||0.3135|1-Sided|98.4||17.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (40 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (40 mcg/kg) arm.|
1748071|NCT00376935|3212219|Superiority or Other||Shift parameter|-9.0||||0.1996|1-Sided|98.4||14.0||P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.|Wilcoxon (Mann-Whitney)|One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.|The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X<0 indicates that palifermen is beneficial.|The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (20 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (20 mcg/kg) arm.|
1748072|NCT00376675|3212233|Superiority or Other|||||||0.317|||||||Wilcoxon rank sum test||||
1748073|NCT00376558|3212239|Superiority or Other||delta bpnd|-12.0|Standard Deviation|7.0||0.001|2-Sided|95.0|||||t-test, 2 sided|||The limbic striatum was our primary region of interest using an unpaired t test to compare BPND and deltaBPND between the treatment responders and non-responders.|
1748074|NCT00376558|3212240|Superiority or Other|||||||0.003|||||||ANOVA||||
1748075|NCT00376168|3212260|Superiority or Other|||||||0.0031|||||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.|
1748076|NCT00376168|3212260|Superiority or Other|||||||0.046|||||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.|
1748077|NCT00376168|3212261|Superiority or Other||||||<|0.0001|||||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.|
1748078|NCT00376168|3212261|Superiority or Other||||||<|0.001|||||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.|
1748079|NCT00376168|3212262|Superiority or Other||||||<|0.0001|||||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.|
1748080|NCT00376168|3212262|Superiority or Other||||||<|0.0041|||||||One-sample t-test|||For each of the secondary endpoints, a one-sample t-test (% change in liver volume, mean change in hemoglobin and platelet count) was examined first for each dose using the step-down approach. Next, a mixed effects model that included dose and time, with subject as a random effect, was fit to examine whether there was a difference between dose groups, for those outcomes that were tested in the step-down approach.|
1748113|NCT00373958|3212490|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.78|||||2-Sided|95.0|0.62|1.0||||||For Rubella the GMC ratio (13vPnC/7vPnC) was calculated|
1749525|NCT00360334|3214293|Superiority or Other|||||||0.601|||||||ANCOVA||||
1748081|NCT00376168|3212263|Superiority or Other||||||<|0.0001||||||threshold for statistical significance = 0.025|one-sample t-test|one-sample t-test (combined) to test the null hypothesis that percent change = 0||"The primary efficacy analysis was based on two one-sample t-tests (one for each treatment group) to determine if the percent change in spleen volume is different than zero.~With 12 patients in each treatment group, there was greater than 95% power to detect a change of 20% or more using a one-sample t-test (alpha=0.025, 2-sided test to allow for each group to be tested separately) to evaluate the primary outcome of percent change in spleen volume after nine months."|
1748082|NCT00376168|3212263|Superiority or Other||||||<|0.0001|||||||one-sample t-test|one-sample t-test (combined) to test the null hypothesis that percent change = 0||"The primary efficacy analysis was based on two one-sample t-tests (one for each treatment group) to determine if the percent change in spleen volume is different than zero.~With 12 patients in each treatment group, there was greater than 95% power to detect a change of 20% or more using a one-sample t-test (alpha=0.025, 2-sided test to allow for each group to be tested separately) to evaluate the primary outcome of percent change in spleen volume after nine months."|
1748083|NCT00375973|3212265|Superiority or Other|||||||0.24|||||||Fisher Exact||||
1748084|NCT00375973|3212266|Superiority or Other|||||||0.02|||||||Fisher Exact||||
1748085|NCT00375973|3212267|Superiority or Other|||||||0.06|||||||Regression, Linear||||
1748086|NCT00375973|3212268|Superiority or Other|||||||0.02|||||||Regression, Linear||||
1748087|NCT00375973|3212269|Superiority or Other|||||||0.67|||||||Regression, Linear||||
1748088|NCT00375973|3212270|Superiority or Other|||||||0.05|||||||Regression, Linear||||
1748089|NCT00375973|3212271|Superiority or Other|||||||0.23|||||||Regression, Linear||||
1748090|NCT00375752|3212299|Superiority or Other||Odds Ratio (OR)|14.7||||0.106|2-Sided|95.0|-1.8|31.1|||Fisher Exact||||
1748091|NCT00375713|3212300|Superiority or Other|||||||0.7518|||||||Cochran-Mantel-Haenszel|stratified on the prurity severity score at the previous day of randomization.|||
1748092|NCT00375713|3212301|Superiority or Other|||||||0.3549|||||||ANCOVA|pruritus severity score at baseline has been used as a covariate.||The categorized duration of Pruritus at endpoint during the 14 day treatment period was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor.|
1748093|NCT00375713|3212302|Superiority or Other|||||||0.4369|||||||ANCOVA|Pruritus score is adjusted on pruritus Baseline score.||The mean daily pruritus score at Day 14 visit or at study completion was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor|
1748094|NCT00375713|3212303|Non-Inferiority or Equivalence|The pre-set threshold for non inferiority is -10%.|Difference in proportion of responders|0.00069213||||||95.0|-0.0875|0.0888||||||The lower bound of the 95% two sided confidence interval for the difference (Levocetirizine - Cetirizine) in percentage of responders is compared to the pre-set threshold for non inferiority (-10% which is equal to -0.1 for the proportion of responders). Standard method for estimation of the difference in proportions incl. confidence interval using normal approximation is used.|
1748095|NCT00375674|3212312|Superiority||Hazard Ratio (HR)|0.929||||0.661|2-Sided|95.0|0.67|1.289|||Log-rank test|||Hazard ratio was based on the Cox Proportional hazards model stratified by UISS High-Risk Group.|
1748096|NCT00375674|3212313|Superiority||Cox Proportional Hazard|0.811||||0.077|2-Sided|95.0|0.643|1.023|||Cox Proportional hazards model|Based on the Cox Proportional hazards model stratified by UISS High-Risk Group||Superiority analysis|
1748097|NCT00375674|3212314|Superiority||Cox Proportional Hazard|0.761||||0.03|2-Sided|95.0|0.594|0.975|||Cox Proportional hazards model|Based on the Cox Proportional hazards model stratified by UISS High-Risk Group.||Superiority analysis|
1748098|NCT00375492|3212338|Superiority or Other|||||||0.127|||||||ANOVA||||
1748099|NCT00375492|3212339|Superiority or Other|||||||0.728|||||||Cochran-Mantel-Haenszel||||
1748100|NCT00375492|3212340|Superiority or Other|||||||0.0654|||||||ANCOVA||||
1748101|NCT00375492|3212341|Superiority or Other|||||||0.2881|||||||ANCOVA||||
1748102|NCT00375492|3212342|Superiority or Other|||||||0.8334|||||||ANCOVA||||
1748103|NCT00375492|3212343|Superiority or Other|||||||0.8279|||||||ANCOVA||||
1748104|NCT00375492|3212344|Superiority or Other|||||||0.1584|||||||ANCOVA||||
1748105|NCT00375492|3212345|Superiority or Other|||||||0.1827|||||||ANCOVA||||
1748106|NCT00375492|3212346|Superiority or Other|||||||0.1985|||||||Mixed Model Repeated Measures||||
1748107|NCT00375492|3212348|Superiority or Other||||||<|0.0001|||||||Mixed Model Repeated Measures||||
1748108|NCT00375492|3212349|Superiority or Other|||||||0.003|||||||Mixed Model Repeated Measures||||
1748109|NCT00374907|3212382|Superiority or Other||Adjusted Percent Difference|27.9||||0.0204|2-Sided|95.0|4.2|57.1||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.|ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment||
1748110|NCT00374907|3212383|Superiority or Other||Adjusted Percent Difference|18.5||||0.035|2-Sided|95.0|1.3|38.7||Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted percent difference for saxagliptin 5 mg vs placebo in Week 12 (LOCF) to baseline ratio. Adjusted for baseline.|ANCOVA model: logarithm(post/pre) = logarithm(pre) treatment||
1748111|NCT00374452|3212430|Other||||||>|0.1|||||||Mixed Models Analysis|||We compared the mean percentages of events per clinician between study arms, using mixed model regression adjusting for medical center, clinic type (community-based clinic vs not), clinician discipline (MD vs non-MD), presence of pharmacist in the clinic, and mean age of clinician's panels of patients as fixed effects, and clinic as a random effect to account for clustering of clinicians within clinics.|
1748112|NCT00374322|3212449|Superiority or Other||Hazard Ratio (HR)|0.91||||0.286|2-Sided|95.0|0.77|1.08||The p-value was calculated from a stratified log-rank test, stratifying for hormone receptor status, time since initial diagnosis, and lymph node involvement.|Log Rank||Estimate of the treatment hazard ratio (HR) was calcuated using the pike estimator.||
1748114|NCT00373958|3212491|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.01|||||2-Sided|95.0|0.92|1.1||||||For Varicella the GMC ratio (13vPnC/7vPnC) was calculated|
1748115|NCT00373958|3212491|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.0|||||2-Sided|95.0|0.87|1.14||||||For Mumps the GMC ratio (13vPnC/7vPnC) was calculated|
1748116|NCT00373958|3212491|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.96|||||2-Sided|95.0|0.85|1.08||||||For Measles the GMC ratio (13vPnC/7vPnC) was calculated|
1748117|NCT00373958|3212492|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.75|1.17||||||For Haemophilus influenzae type b (PRP) the GMC ratio (13vPnC/7vPnC) was calculated|
1748118|NCT00373958|3212493|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|4.8||||||95.0|-3.4|13.0||||||For Varicella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.09 I.V. threshold was calculated.|
1748119|NCT00373958|3212493|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -5%.|Difference|1.2||||||95.0|-4.4|6.9||||||For Rubella the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥15 IU/mL threshold was calculated.|
1748120|NCT00373958|3212493|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -5%.|Difference|3.6||||||95.0|-4.7|11.9||||||For Mumps the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.|
1748121|NCT00373958|3212493|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -5%.|Difference|-0.8||||||95.0|-4.5|2.9||||||For Measles the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1.10 I.V. threshold was calculated.|
1748122|NCT00373958|3212493|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-1.6||||||95.0|-7.1|3.8||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0μg/mL threshold was calculated.|
1748123|NCT00373958|3212493|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.|
1748124|NCT00373958|3212494|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was > -10%.|Difference|-2.1||||||95.0|-6.4|2.0||||||For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 26 EU/mL threshold was calculated.|
1748125|NCT00373958|3212494|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was > -10%.|Difference|-0.9||||||95.0|-5.2|3.4||||||For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 16.5 EU/mL threshold was calculated.|
1748126|NCT00373958|3212494|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was > -10%.|Difference|1.7||||||95.0|-2.1|5.6||||||For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 40.5 EU/mL threshold was calculated.|
1748127|NCT00373958|3212494|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was > -10%.|Difference|-0.4||||||95.0|-4.3|3.5||||||For diphtheria toxoid the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.|
1748128|NCT00373958|3212494|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was > -10%.|Difference|-0.6||||||95.0|-8.3|7.0||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.|
1748129|NCT00373958|3212494|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) was > -10%.|Difference|0.1||||||95.0|-2.9|3.1||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15μg/mL threshold was calculated.|
1748130|NCT00373958|3212495|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|0.65||||||95.0|0.54|0.78||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated|
1748131|NCT00373958|3212495|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|1.18||||||95.0|0.98|1.41||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated|
1748132|NCT00373958|3212495|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|0.68||||||95.0|0.57|0.81||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated|
1748133|NCT00373958|3212495|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.6|0.86||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated|
1749526|NCT00360334|3214294|Superiority or Other|||||||0.471|||||||ANCOVA||||
1748134|NCT00373958|3212495|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.62|0.85||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated|
1748135|NCT00373958|3212495|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|0.74||||||95.0|0.61|0.89||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated|
1748136|NCT00373958|3212495|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|0.68||||||95.0|0.57|0.8||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated|
1748137|NCT00373958|3212496|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-3.6||||||95.0|-8.5|1.2||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748138|NCT00373958|3212496|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.4||||||95.0|-2.4|3.4||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748139|NCT00373958|3212496|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-1.6||||||95.0|-4.7|1.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748140|NCT00373958|3212496|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.4||||||95.0|-2.7|3.5||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748141|NCT00373958|3212496|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-7.9||||||95.0|-12.4|-4.0||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748142|NCT00373958|3212496|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-5.5||||||95.0|-10.9|-0.1||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748143|NCT00373958|3212496|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-3.6||||||95.0|-7.3|-0.1||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748144|NCT00373685|3212507|Superiority or Other|||||||0.0001|||||||Chi-squared|||Week 24/LOCF|
1748145|NCT00373685|3212507|Superiority or Other|||||||0.0027|||||||Chi-squared|||Week 24 or ET|
1748146|NCT00373685|3212507|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Week 16|
1748147|NCT00373685|3212507|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Week 8|
1748148|NCT00373685|3212507|Superiority or Other||||||<|0.2699|||||||Chi-squared|||Baseline|
1748149|NCT00373685|3212508|Superiority or Other|||||||0.0019|||||||Chi-squared|||Week 24/LOCF|
1748150|NCT00373685|3212508|Superiority or Other|||||||0.0127|||||||Chi-squared|||Week 24 or ET|
1748151|NCT00373685|3212508|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Week 16|
1748152|NCT00373685|3212508|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Week 8|
1748153|NCT00373685|3212508|Superiority or Other||||||<|0.4074|||||||Chi-squared|||Baseline|
1748154|NCT00373685|3212509|Superiority or Other|||||||0.0074|||||||Chi-squared|||Week 24/LOCF|
1748155|NCT00373685|3212509|Superiority or Other|||||||0.0245|||||||Chi-squared|||Week 24 or ET|
1748156|NCT00373685|3212509|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Week 16|
1748157|NCT00373685|3212509|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Week 8|
1748158|NCT00373685|3212509|Superiority or Other||||||<|0.6562|||||||Chi-squared|||Baseline|
1748159|NCT00373685|3212510|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Week 24/LOCF|
1748160|NCT00373685|3212510|Superiority or Other||||||<|0.0005|||||||Chi-squared|||Week 24 or ET|
1748161|NCT00373685|3212510|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Week 16|
1748162|NCT00373685|3212510|Superiority or Other||||||<|0.0001|||||||Chi-squared|||Week 8|
1748163|NCT00373685|3212510|Superiority or Other||||||<|0.1008|||||||Chi-squared|||Baseline|
1748164|NCT00373685|3212511|Superiority or Other|||||||0.0023||||||P-value associated with Overall (LOCF)|Cochran-Mantel-Haenszel||||
1748165|NCT00373685|3212512|Superiority or Other||||||<|0.0001||||||P-value associated with Overall (LOCF)|ANCOVA||||
1748166|NCT00373685|3212514|Superiority or Other||||||<|0.0001||||||P-value associated with Overall (LOCF)|ANCOVA||||
1748167|NCT00373685|3212516|Superiority or Other|||||||0.614|||||||Life Table Extension of CMH Test||||
1748168|NCT00373685|3212517|Superiority or Other|||||||0.0035|||||||Life Table Extension of CMH Test||||
1748169|NCT00373685|3212518|Superiority or Other|||||||0.0003||||||Life Table Extension of Cochran-Mantel-Haenszel (CMH) Test|Life Table Extension of CMH Test||||
1748170|NCT00373425|3212536|Superiority or Other||Hazard Ratio (HR)|0.94||||0.562|2-Sided|95.0|0.78|1.144|||Log Rank|||The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level.|
1748212|NCT00373113|3212595|Superiority or Other||Hazard Ratio (HR)|2.788||||0.037|2-Sided|95.0|1.042|7.459|||Log Rank||||
1748213|NCT00373113|3212596|Superiority or Other||Mean Difference (Final Values)|-5.049||||0.109|2-Sided|95.0|-11.2|1.1|||Pearson Chi-Square Test||||
1748214|NCT00373113|3212596|Superiority or Other||Objective Response Rate (ORR) (percent)|16.4|||||2-Sided|95.0|12.0|21.6|||||||
1748215|NCT00373113|3212596|Superiority or Other||Objective Response Rate (ORR) (percent)|11.3|||||2-Sided|95.0|7.6|16.1|||||||
1748171|NCT00373425|3212541|Superiority or Other||Hazard Ratio (HR)|0.9||||0.3235|2-Sided|95.0|0.741|1.104||If the primary analysis of DFS was not statistically significant, the hierarchical testing procedure would stop and all key secondary efficacy analyses would be nonsignificant; any further analysis of these outcomes would be considered exploratory.|Log Rank||Hazard ratio: erlotinib to placebo|The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level. The primary analysis of DFS was performed when at least 410 events had accrued. If the result of the primary analysis of DFS was statistically significant favoring the erlotinib treatment arm, the null hypothesis of no treatment difference of key secondary efficacy variables was tested under a hierarchical testing procedure.|
1748172|NCT00373386|3212543|Superiority or Other|||||||0.648|||||||t-test, 2 sided|||Comparison with baseline|
1748173|NCT00373386|3212544|Superiority or Other|||||||0.095|||||||t-test, 2 sided|||Comparison with baseline|
1748174|NCT00373386|3212545|Superiority or Other|||||||0.804|||||||t-test, 2 sided|||Comparison with baseline|
1748175|NCT00373386|3212546|Superiority or Other|||||||0.004|||||||t-test, 2 sided|||Comparison with baseline|
1748176|NCT00373386|3212547|Superiority or Other|||||||0.04|||||||t-test, 2 sided|||Comparison to baseline|
1748177|NCT00373386|3212548|Superiority or Other|||||||0.018||||||Versus baseline|t-test, 2 sided|paired||Compared with baseline|
1748178|NCT00373386|3212549|Superiority or Other|||||||0.644|||||||t-test, 2 sided|||compared with baseline|
1748179|NCT00373360|3212553|Superiority or Other|||||||0.004|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748180|NCT00373360|3212554|Superiority or Other|||||||0.297|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748181|NCT00373360|3212555|Superiority or Other|||||||0.207|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748182|NCT00373360|3212556|Superiority or Other|||||||0.25|||||||Wilcoxon signed rank test|||Change from Baseline to Week 8|
1748183|NCT00373360|3212560|Superiority or Other|||||||0.203|||||||Wilcoxon signed rank test|||Change Between Baseline and Week 8|
1748184|NCT00373360|3212561|Superiority or Other|||||||0.063|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748185|NCT00373360|3212562|Superiority or Other|||||||0.004|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748186|NCT00373360|3212563|Superiority or Other|||||||0.031|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748187|NCT00373360|3212564|Superiority or Other|||||||0.031|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748188|NCT00373360|3212565|Superiority or Other|||||||1|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748189|NCT00373360|3212566|Superiority or Other|||||||0|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748190|NCT00373360|3212567|Superiority or Other|||||||1|||||||Wilcoxon signed rank test|||Change from Baseline to Week 8|
1748191|NCT00373360|3212568|Superiority or Other|||||||1|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748192|NCT00373360|3212569|Superiority or Other|||||||0.5|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748193|NCT00373360|3212570|Superiority or Other|||||||1|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748194|NCT00373360|3212571|Superiority or Other|||||||0.531|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748195|NCT00373360|3212572|Superiority or Other|||||||1|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748196|NCT00373360|3212573|Superiority or Other|||||||0.008|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748197|NCT00373360|3212574|Superiority or Other|||||||1|||||||Wilcoxon signed rank test|||Change between Baseline and Week 8|
1748198|NCT00373334|3212575|Superiority or Other|||||||0.938|||||||Chi-squared|||Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).|
1748199|NCT00373334|3212575|Superiority or Other|||||||0.609|||||||Chi-squared|||Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).|
1748200|NCT00373334|3212576|Superiority or Other|||||||0.262|||||||Chi-squared|||Comparison of nizatidine 5.0 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).|
1748201|NCT00373334|3212576|Superiority or Other|||||||0.746|||||||Chi-squared|||Comparison of nizatidine 2.5 group to placebo group. P-value is for overall difference between groups (not comparison of individual categories).|
1748202|NCT00373334|3212577|Superiority or Other|||||||0.341|||||||Cochran-Mantel-Haenszel||||
1748203|NCT00373334|3212577|Superiority or Other|||||||0.528|||||||Cochran-Mantel-Haenszel||||
1748204|NCT00373256|3212586|Superiority or Other||Percentage|61.0|||||2-Sided|95.0|43.2|74.7||||||2 years|
1748205|NCT00373256|3212586|Superiority or Other||Percentage|83.7|||||2-Sided|95.0|76.0|89.1||||||1 year|
1748206|NCT00373256|3212586|Superiority or Other||Percentage|35.5|||||2-Sided|95.0|20.9|50.3||||||2 years|
1748207|NCT00373256|3212586|Superiority or Other||Percentage|76.8|||||2-Sided|95.0|68.7|83.0||||||1 year|
1748208|NCT00373256|3212589|Superiority or Other||Objective Response Rate (ORR) (percent)|32.1|||||2-Sided|95.0|26.3|38.4|||||||
1748209|NCT00373256|3212589|Superiority or Other||Objective Response Rate (ORR) (percent)|32.2|||||2-Sided|95.0|26.4|38.5|||||||
1748210|NCT00373256|3212590|Superiority or Other||Hazard Ratio (HR)|1.6299||||0.9986|2-Sided|95.0|1.1793|2.2527||p-value from 1-sided log-rank stratified for prior adjuvant chemotherapy, hormone receptor status, disease-free interval from prior adjuvant treatment. Stratification factors from Interactive Voice Randomization System.|Log Rank||Assuming proportional hazards, a hazard ratio greater than 1 indicated a reduction in hazard rate in favor Bevacizumab + Paclitaxel.||
1748211|NCT00373113|3212593|Superiority or Other||Hazard Ratio (HR)|1.202||||0.219|2-Sided|95.0|0.896|1.611||2-sided log-rank test with the same set of stratification factors that were used in the randomization except study sites.|Log Rank||||
1748216|NCT00373113|3212597|Superiority or Other||Hazard Ratio (HR)|1.516|||<|0.001|2-Sided|95.0|1.188|1.933||2-sided log-rank test with the same set of stratification factors that was used in the randomization except study sites.|Log Rank||Hazard ratio was calculated by the stratified Cox proportional hazards model.||
1748217|NCT00373113|3212598|Superiority or Other||Hazard Ratio (HR)|1.47||||0.002|2-Sided|95.0|1.156|1.869||2-sided log-rank test with the same set of stratification factors. The set of stratification factors included those used in the randomization except study sites.|Log Rank||Hazard ratio was calculated by the stratified Cox proportional hazards model.|Null hypothesis is that PFS (median=4.2 months) for sunitinib arm equals PFS for capecitabine arm. The study was designed to have 90% power to detect statistical difference in PFS between two treatment groups assuming the hazard ratio (sunitinib/capecitabine) is 0.75 and both arms follow exponential distribution.|
1748218|NCT00372996|3212607|Superiority or Other||Mean Difference (Net)|4.79||||0.463|2-Sided|95.0|-8.0|17.6|||Pearson chi-square test||||
1748219|NCT00372996|3212608|Superiority or Other||Hazard Ratio (HR)|0.764||||0.331|2-Sided|70.0|0.572|1.02||2-sided p-value from unstratified log-rank test|Log Rank||Hazard ratio was based on the Cox proportional hazards model.||
1748220|NCT00372996|3212609|Superiority or Other||Hazard Ratio (HR)|0.912||||0.56|2-Sided|80.0|0.744|1.118|||Log Rank|2-sided p-value from an unstratified log-rank text|Hazard ratio was based on Cox proportional hazards model.||
1748221|NCT00372957|3212612|Superiority or Other||Mean Difference (Final Values)|-6.2|||||2-Sided|95.0|-23.4|11.1|||||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7|
1748222|NCT00372957|3212612|Superiority or Other||Mean Difference (Final Values)|-15.9|||||2-Sided|95.0|-33.2|1.4|||||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7|
1748223|NCT00372957|3212612|Superiority or Other||Mean Difference (Final Values)|-9.0|||||2-Sided|95.0|-29.8|11.7|||||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7|
1748224|NCT00372957|3212612|Superiority or Other||Mean Difference (Final Values)|-19.9|||||2-Sided|95.0|-40.7|0.9|||||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7|
1748225|NCT00372957|3212613|Superiority or Other||Mean Difference (Final Values)|0.48|||||2-Sided|95.0|-0.24|1.21|||||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7|
1748226|NCT00372957|3212613|Superiority or Other||Mean Difference (Final Values)|0.35|||||2-Sided|95.0|-0.37|1.07|||||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7|
1748227|NCT00372957|3212613|Superiority or Other||Mean Difference (Final Values)|0.43|||||2-Sided|95.0|-0.47|1.32|||||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7|
1748228|NCT00372957|3212613|Superiority or Other||Mean Difference (Final Values)|0.26|||||2-Sided|95.0|-0.64|1.16|||||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7|
1748229|NCT00372957|3212614|Superiority or Other||Mean Difference (Final Values)|-15.6|||||2-Sided|95.0|-27.9|-3.3|||||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7|
1748230|NCT00372957|3212614|Superiority or Other||Mean Difference (Final Values)|-10.9|||||2-Sided|95.0|-23.1|1.4|||||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7|
1748231|NCT00372957|3212614|Superiority or Other||Mean Difference (Final Values)|-16.2|||||2-Sided|95.0|-28.4|-3.9|||||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7|
1748232|NCT00372957|3212614|Superiority or Other||Mean Difference (Final Values)|-8.1|||||2-Sided|95.0|-20.4|4.2|||||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7|
1748233|NCT00372957|3212615|Superiority or Other||Mean Difference (Final Values)|1.48|||||2-Sided|95.0|-2.47|5.43|||||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7|
1748234|NCT00372957|3212615|Superiority or Other||Mean Difference (Final Values)|-1.35|||||2-Sided|95.0|-5.2|2.5|||||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7|
1748235|NCT00372957|3212615|Superiority or Other||Mean Difference (Final Values)|1.21|||||2-Sided|95.0|-3.3|5.72|||||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7|
1748236|NCT00372957|3212615|Superiority or Other||Mean Difference (Final Values)|-1.56|||||2-Sided|95.0|-6.0|2.89|||||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7|
1748237|NCT00372957|3212616|Superiority or Other||Mean Difference (Final Values)|4.39|||||2-Sided|95.0|3.1|5.68|||||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7|
1748238|NCT00372957|3212616|Superiority or Other||Mean Difference (Final Values)|3.22|||||2-Sided|95.0|1.9|4.54|||||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7|
1748239|NCT00372957|3212616|Superiority or Other||Mean Difference (Final Values)|5.21|||||2-Sided|95.0|3.7|6.73|||||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7|
1748240|NCT00372957|3212616|Superiority or Other||Mean Difference (Final Values)|3.87|||||2-Sided|95.0|2.33|5.41|||||he point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7|
1748241|NCT00372957|3212617|Superiority or Other||Mean Difference (Final Values)|-2.12|||||2-Sided|95.0|-2.28|-1.95|||||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-24 hr), Day 7|
1748242|NCT00372957|3212617|Superiority or Other||Mean Difference (Final Values)|-1.98|||||2-Sided|95.0|-2.15|-1.82|||||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-24 hr), Day 7|
1748243|NCT00372957|3212617|Superiority or Other||Mean Difference (Final Values)|-2.16|||||2-Sided|95.0|-2.33|-1.98|||||The point estimate is the least square mean difference between placebo and GW 823093C 30 mg.|AUC(0-12 hr), Day 7|
1748244|NCT00372957|3212617|Superiority or Other||Mean Difference (Final Values)|-2.1|||||2-Sided|95.0|-2.28|-1.93|||||The point estimate is the least square mean difference between placebo and GW 823093C 15 mg.|AUC(0-12 hr), Day 7|
1748245|NCT00372775|3212640|Superiority or Other||Percentage|23.4|||||2-Sided|95.0|14.0|34.3|||||Probability of survival along with the corresponding 2-sided confidence interval for the log [-log(one-year survival rate)] calculated using a normal approximation and then back transformed to give a confidence interval for the one-year survival||
1748246|NCT00372775|3212643|Superiority or Other||ORR (percent)|4.3|||||2-Sided|95.0|0.1|21.9|||||Two-Sided CI from Exact Method using the F Distribution||
1748247|NCT00372775|3212645|Superiority or Other||Objective Response Rate (ORR) (percent)|1.6|||||2-Sided|95.0|0.0|8.8|||||Two-Sided Confidence Interval (CI) from Exact Method using the F Distribution||
1748248|NCT00372567|3212670|Superiority or Other||Odds Ratio (OR)|1.318|||||2-Sided|95.0|0.5|3.8|||||||
1748249|NCT00372567|3212671|Superiority or Other||Odds Ratio (OR)|0.379|||||2-Sided|95.0|0.1|2.3|||||||
1748250|NCT00372567|3212672|Superiority or Other||Hazard Ratio (HR)|3.434|||||2-Sided|95.0|1.057|11.15|||||||
1748251|NCT00372567|3212675|Superiority or Other||Odds Ratio (OR)|2.308|||||2-Sided|95.0|0.4|13.0|||||||
1748252|NCT00372567|3212676|Superiority or Other||Hazard Ratio (HR)|1.027|||||2-Sided|95.0|0.505|2.088|||||||
1748253|NCT00372567|3212678|Superiority or Other||Hazard Ratio (HR)|2.818|||||2-Sided|95.0|0.64|12.41|||||||
1748254|NCT00372567|3212679|Superiority or Other||Hazard Ratio (HR)|1.04|||||2-Sided|95.0|0.484|2.235||||||No hypothesis tested.|
1748255|NCT00372411|3212691|Superiority or Other||Mean Difference (Net)|-0.19||||0.1|2-Sided|95.0|-0.42|0.04||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.|
1748256|NCT00372411|3212691|Superiority or Other||Mean Difference (Net)|0.01||||0.95|2-Sided|95.0|-0.25|0.26||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.|
1748257|NCT00372411|3212692|Superiority or Other||Mean Difference (Net)|-0.84||||0.03|2-Sided|95.0|-1.62|-0.06||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.|
1748258|NCT00372411|3212692|Superiority or Other||Mean Difference (Net)|-0.81||||0.08|2-Sided|95.0|-1.73|0.11||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.|
1748259|NCT00372411|3212693|Superiority or Other||Mean Difference (Net)|-2.13||||0.55|2-Sided|95.0|-9.2|4.93||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.|
1748260|NCT00372411|3212693|Superiority or Other||Mean Difference (Net)|0.93||||0.82|2-Sided|95.0|-7.03|8.89||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.|
1748261|NCT00372411|3212693|Superiority or Other||Mean Difference (Net)|-8.1||||0.005|2-Sided|95.0|-13.61|-2.6||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.|
1748262|NCT00372411|3212693|Superiority or Other||Mean Difference (Net)|-4.41||||0.22|2-Sided|95.0|-11.52|2.7||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.|
1748263|NCT00372411|3212694|Superiority or Other||Mean Difference (Net)|1.19||||0.55|2-Sided|95.0|-2.74|5.12||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.|
1748264|NCT00372411|3212694|Superiority or Other||Mean Difference (Net)|0.54||||0.81|2-Sided|95.0|-3.87|4.94||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|ANCOVA|Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.|
1748294|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.54|||||2-Sided|95.0|-0.97|-0.12||||||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 7.|
1748265|NCT00372411|3212694|Superiority or Other||Mean Difference (Net)|5.95||||0.04|2-Sided|95.0|0.34|11.56||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.|
1748266|NCT00372411|3212694|Superiority or Other||Mean Difference (Net)|7.64||||0.009|2-Sided|95.0|2.03|13.24||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.||Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.|
1748267|NCT00372411|3212695|Superiority or Other||Median Difference (Net)|-0.58||||0.63|2-Sided|95.0|-2.97|1.81||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.|
1748268|NCT00372411|3212695|Superiority or Other||Mean Difference (Net)|-0.14||||0.92|2-Sided|95.0|-2.94|2.65||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.||Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated.|
1748269|NCT00372411|3212695|Superiority or Other||Mean Difference (Net)|2.88||||0.02|2-Sided|95.0|0.57|5.18||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.|Mixed Models Analysis|Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.||Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.|
1748270|NCT00372411|3212695|Superiority or Other||Mean Difference (Net)|2.17||||0.08|2-Sided|95.0|-0.23|4.58||All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses|ANCOVA|Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.||Because randomization to usual care was stopped after 15 months as specified by the protocol, comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period.|
1748271|NCT00372385|3212700|Superiority or Other||Odds Ratio (OR)|0.591||||0.1099|2-Sided|95.0|0.311|1.126|||Regression, Logistic||||
1748272|NCT00372385|3212700|Superiority or Other||Odds Ratio (OR)|1.623||||0.1324|2-Sided|95.0|0.864|3.05|||Regression, Logistic||||
1748273|NCT00372385|3212700|Superiority or Other||Odds Ratio (OR)|2.632||||0.0041|2-Sided|95.0|1.359|5.097|||Regression, Logistic||||
1748274|NCT00372385|3212701|Superiority or Other||Odds Ratio (OR)|0.589||||0.1089|2-Sided|95.0|0.309|1.125|||Regression, Logistic||||
1748275|NCT00372385|3212701|Superiority or Other||Odds Ratio (OR)|1.709||||0.959|2-Sided|95.0|0.91|3.212|||Regression, Logistic||||
1748276|NCT00372385|3212701|Superiority or Other||Odds Ratio (OR)|2.758||||0.0026|2-Sided|95.0|1.424|5.34|||Regression, Logistic||||
1748277|NCT00372229|3212719|Other|Descriptive analysis|Mean Difference (Final Values)|12.1|Standard Error of the Mean|6.21|||2-Sided|95.0|-0.1|24.2|||||||
1748278|NCT00372229|3212720|Other|Descriptive analysis|Mean Difference (Final Values)|-3.2|Standard Error of the Mean|8.71|||2-Sided|95.0|-20.2|13.9|||||||
1748279|NCT00372229|3212753|Superiority or Other (legacy)||Mean Difference (Final Values)|0.2509|Standard Error of the Mean|0.1838||0.1739|2-Sided|99.0|-0.2271|0.7289|||F-test||||
1748280|NCT00372229|3212754|Superiority or Other (legacy)||Difference|-11.3|Standard Error of the Mean|3.83|||2-Sided|96.0|-19.2|-3.4|||||||
1748281|NCT00372229|3212755|Superiority or Other (legacy)||Difference|-28.5|Standard Error of the Mean|5.45|||2-Sided|96.0|-39.7|-17.3|||||||
1748282|NCT00372190|3212759|Superiority or Other||||||<|0.05|||||||Chi-squared||||
1748283|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.04|||||2-Sided|95.0|-0.26|0.34||||||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 15.|
1748284|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.35|||||2-Sided|95.0|-0.66|-0.05||||||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 15.|
1748285|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.05|||||2-Sided|95.0|-0.25|0.35||||||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 15.|
1748286|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.06|||||2-Sided|95.0|-0.34|0.21||||||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 14.|
1748287|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.23|||||2-Sided|95.0|-0.51|0.04||||||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 14.|
1748288|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.15|||||2-Sided|95.0|-0.42|0.12||||||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 14.|
1748289|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.04|||||2-Sided|95.0|-0.26|0.34||||||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 8.|
1748290|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.4|||||2-Sided|95.0|-0.7|-0.1||||||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 8.|
1748291|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.03|||||2-Sided|95.0|-0.26|0.33||||||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 8.|
1748292|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.34|||||2-Sided|95.0|-0.76|0.08||||||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 7.|
1748293|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.55|||||2-Sided|95.0|-0.98|-0.12||||||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 7.|
1748295|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.02|||||2-Sided|95.0|-0.37|0.34||||||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 2.|
1748296|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.38|||||2-Sided|95.0|-0.73|-0.03||||||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 2.|
1748297|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.1|||||2-Sided|95.0|-0.47|0.27||||||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 2.|
1748298|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.19|||||2-Sided|95.0|-0.46|0.07||||||Placebo versus Salmeterol 50 mcg BD for minimum potassium 0-4 h at Day 1.|
1748299|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.22|||||2-Sided|95.0|-0.49|0.04||||||Placebo versus GW642444 400 mcg once daily for minimum potassium 0-4 h at Day 1.|
1748300|NCT00372112|3212772|Superiority||Mean Difference (Final Values)|-0.19|||||2-Sided|95.0|-0.47|0.09||||||Placebo versus GW642444 100 mcg once daily for minimum potassium 0-4 h at Day 1.|
1748301|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.49|||||2-Sided|95.0|-0.5|1.48||||||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 15.|
1748302|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.84|||||2-Sided|95.0|-0.21|1.89||||||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 15.|
1748303|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.22|||||2-Sided|95.0|-0.78|1.23||||||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 15.|
1748304|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.0|||||2-Sided|95.0|-1.23|1.23||||||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 14.|
1748305|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.75|||||2-Sided|95.0|-0.53|2.03||||||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 14.|
1748306|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.05|||||2-Sided|95.0|-1.2|1.3||||||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 14.|
1748307|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.32|||||2-Sided|95.0|-0.9|1.54||||||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 8.|
1748308|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.86|||||2-Sided|95.0|-0.42|2.14||||||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 8.|
1748309|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.26|||||2-Sided|95.0|-0.98|1.5||||||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 8.|
1748310|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.13|||||2-Sided|95.0|-0.89|1.15||||||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 7.|
1748311|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.53|||||2-Sided|95.0|-0.57|1.62||||||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 7.|
1748312|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.05|||||2-Sided|95.0|-1.11|1.01||||||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 7.|
1748313|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.23|||||2-Sided|95.0|-0.74|1.2||||||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 2.|
1748314|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.69|||||2-Sided|95.0|-0.32|1.7||||||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 2.|
1748315|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.4|||||2-Sided|95.0|-0.64|1.44||||||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 2.|
1748316|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.17|||||2-Sided|95.0|-1.15|0.8||||||Placebo versus Salmeterol 50 mcg BD for maximum glucose 0-4 h at Day 1.|
1748317|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.29|||||2-Sided|95.0|-0.72|1.3||||||Placebo versus GW642444 400 mcg once daily for maximum glucose 0-4 h at Day 1.|
1748318|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.14|||||2-Sided|95.0|-1.18|0.9||||||Placebo versus GW642444 100 mcg once daily for maximum glucose 0-4 h at Day 1.|
1748319|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.139|||||2-Sided|95.0|-0.198|0.475||||||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 15.|
1748320|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.196|||||2-Sided|95.0|-0.535|0.143||||||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 15.|
1748321|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.173|||||2-Sided|95.0|-0.158|0.505||||||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 15.|
1748322|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.095|||||2-Sided|95.0|-0.432|0.243||||||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 14.|
1748323|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.271|||||2-Sided|95.0|-0.621|0.079||||||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 14.|
1748324|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.299|||||2-Sided|95.0|-0.64|0.042||||||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 14.|
1748325|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.103|||||2-Sided|95.0|-0.213|0.418||||||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 8.|
1748326|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.275|||||2-Sided|95.0|-0.623|0.073||||||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 8.|
1748327|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.075|||||2-Sided|95.0|-0.235|0.385||||||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 8.|
1748328|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.19|||||2-Sided|95.0|-0.575|0.196||||||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 7.|
1748329|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.562|||||2-Sided|95.0|-0.99|-0.135||||||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 7.|
1748330|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.486|||||2-Sided|95.0|-0.878|-0.095||||||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 7.|
1748331|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.018|||||2-Sided|95.0|-0.452|0.416||||||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 2.|
1748332|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.536|||||2-Sided|95.0|-0.998|-0.074||||||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 2.|
1748333|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.216|||||2-Sided|95.0|-0.679|0.247||||||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 2.|
1748334|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.153|||||2-Sided|95.0|-0.44|0.133||||||Placebo versus Salmeterol 50 mcg BD for weighted mean potassium 0-4 h at Day 1.|
1748335|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.371|||||2-Sided|95.0|-0.657|-0.085||||||Placebo versus GW642444 400 mcg once daily for weighted mean potassium 0-4 h at Day 1.|
1748336|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.294|||||2-Sided|95.0|-0.586|-0.001||||||Placebo versus GW642444 100 mcg once daily for weighted mean potassium 0-4 h at Day 1.|
1748337|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.178|||||2-Sided|95.0|-0.522|0.877||||||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 15.|
1748338|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.358|||||2-Sided|95.0|-0.39|1.105||||||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 15.|
1748339|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.094|||||2-Sided|95.0|-0.619|0.806||||||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 15.|
1748340|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.187|||||2-Sided|95.0|-0.765|0.391||||||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 14.|
1748341|NCT00372112|3212772|Superiority||Mean Difference (Net)|-0.138|||||2-Sided|95.0|-0.767|0.491||||||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 14.|
1748342|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.056|||||2-Sided|95.0|-0.556|0.669||||||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 14.|
1748343|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.144|||||2-Sided|95.0|-0.742|1.03||||||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 8.|
1748344|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.796|||||2-Sided|95.0|-0.174|1.766||||||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 8.|
1748345|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.245|||||2-Sided|95.0|-0.66|1.149||||||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 8.|
1748346|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.08|||||2-Sided|95.0|-0.471|0.631||||||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 7.|
1748347|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.408|||||2-Sided|95.0|-0.208|1.024||||||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 7.|
1748348|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.097|||||2-Sided|95.0|-0.476|0.67||||||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 7.|
1748349|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.065|||||2-Sided|95.0|-0.667|0.797||||||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 2.|
1748350|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.633|||||2-Sided|95.0|-0.152|1.418||||||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 2.|
1748351|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.199|||||2-Sided|95.0|-0.591|0.988||||||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 2.|
1748352|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.093|||||2-Sided|95.0|-0.469|0.654||||||Placebo versus Salmeterol 50 mcg BD for weighted mean glucose 0-4 h at Day 1.|
1748353|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.237|||||2-Sided|95.0|-0.354|0.829||||||Placebo versus GW642444 400 mcg once daily for weighted mean glucose 0-4 h at Day 1.|
1748354|NCT00372112|3212772|Superiority||Mean Difference (Net)|0.009|||||2-Sided|95.0|-0.59|0.608||||||Placebo versus GW642444 100 mcg once daily for weighted mean glucose 0-4 h at Day 1.|
1748355|NCT00372112|3212777|Superiority||Mean Difference (Net)|0.0956|||||2-Sided|95.0|-0.0686|0.2599||||||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 14.|
1748356|NCT00372112|3212777|Superiority||Mean Difference (Net)|0.1906|||||2-Sided|95.0|0.0177|0.3635||||||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 14.|
1748357|NCT00372112|3212777|Superiority||Mean Difference (Net)|0.139|||||2-Sided|95.0|-0.0266|0.3046||||||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 14.|
1748358|NCT00372112|3212777|Superiority||Mean Difference (Net)|0.1377|||||2-Sided|95.0|-0.0233|0.2987||||||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 7.|
1748359|NCT00372112|3212777|Superiority||Mean Difference (Net)|0.1713|||||2-Sided|95.0|0.006|0.3365||||||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 7.|
1748360|NCT00372112|3212777|Superiority||Mean Difference (Net)|0.1741|||||2-Sided|95.0|0.0178|0.3305||||||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 7.|
1748361|NCT00372112|3212777|Superiority||Mean Difference (Net)|0.0764|||||2-Sided|95.0|-0.0375|0.1903||||||Placebo versus Salmeterol 50 mcg BD for FEV1 over 22-24 h at Day 1.|
1748362|NCT00372112|3212777|Superiority||Mean Difference (Net)|0.159|||||2-Sided|95.0|0.0408|0.2771||||||Placebo versus GW642444 400 mcg once daily for FEV1 over 22-24 h at Day 1.|
1748363|NCT00372112|3212777|Superiority||Mean Difference (Net)|0.1131|||||2-Sided|95.0|-0.0031|0.2293||||||Placebo versus GW642444 100 mcg once daily for FEV1 over 22-24 h at Day 1.|
1748364|NCT00372112|3212792|Superiority||Mean Difference (Net)|4.4|||||2-Sided|95.0|-4.5|13.3||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 15.|
1748365|NCT00372112|3212792|Superiority||Mean Difference (Net)|6.8|||||2-Sided|95.0|-2.1|15.6||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 15.|
1748366|NCT00372112|3212792|Superiority||Mean Difference (Net)|0.2|||||2-Sided|95.0|-7.8|8.3||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 15.|
1748367|NCT00372112|3212792|Superiority||Mean Difference (Net)|-2.9|||||2-Sided|95.0|-13.8|8.0||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 14.|
1748368|NCT00372112|3212792|Superiority||Mean Difference (Net)|5.4|||||2-Sided|95.0|-6.0|16.8||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 14.|
1748369|NCT00372112|3212792|Superiority||Mean Difference (Net)|-7.2|||||2-Sided|95.0|-17.0|2.7||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 14.|
1748370|NCT00372112|3212792|Superiority||Mean Difference (Net)|3.1|||||2-Sided|95.0|-5.2|11.4||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 8.|
1748612|NCT00368940|3213326|Superiority||Cohen D at week 12|0.6||||0.005|2-Sided|95.0|0.13|1.06|||Mixed Models Analysis||||
1748371|NCT00372112|3212792|Superiority||Mean Difference (Net)|10.8|||||2-Sided|95.0|2.6|19.0||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 8.|
1748372|NCT00372112|3212792|Superiority||Mean Difference (Net)|3.4|||||2-Sided|95.0|-4.1|10.9||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 8.|
1748373|NCT00372112|3212792|Superiority||Mean Difference (Net)|-4.8|||||2-Sided|95.0|-17.1|7.5||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 7.|
1748374|NCT00372112|3212792|Superiority||Mean Difference (Net)|-1.9|||||2-Sided|95.0|-14.0|10.2||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 7.|
1748375|NCT00372112|3212792|Superiority||Mean Difference (Net)|-4.9|||||2-Sided|95.0|-16.1|6.2||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 7.|
1748376|NCT00372112|3212792|Superiority||Mean Difference (Net)|1.6|||||2-Sided|95.0|-6.9|10.1||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 2.|
1748377|NCT00372112|3212792|Superiority||Mean Difference (Net)|5.8|||||2-Sided|95.0|-2.8|14.3||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 2.|
1748378|NCT00372112|3212792|Superiority||Mean Difference (Net)|2.2|||||2-Sided|95.0|-6.1|10.4||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 2.|
1748379|NCT00372112|3212792|Superiority||Mean Difference (Net)|0.0|||||2-Sided|95.0|-10.2|10.1||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h maximum HR at Day 1.|
1748380|NCT00372112|3212792|Superiority||Mean Difference (Net)|3.0|||||2-Sided|95.0|-7.2|13.1||||||Placebo versus GW642444 400 mcg once daily for 0-4 h maximum HR at Day 1.|
1748381|NCT00372112|3212792|Superiority||Mean Difference (Net)|2.1|||||2-Sided|95.0|-7.7|12.0||||||Placebo versus GW642444 100 mcg once daily for 0-4 h maximum HR at Day 1.|
1748382|NCT00372112|3212794|Superiority||Mean Difference (Net)|2.11|||||2-Sided|95.0|-4.96|9.18||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 15.|
1748383|NCT00372112|3212794|Superiority||Mean Difference (Net)|3.59|||||2-Sided|95.0|-3.71|10.89||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 15.|
1748384|NCT00372112|3212794|Superiority||Mean Difference (Net)|-1.12|||||2-Sided|95.0|-7.64|5.4||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 15.|
1748385|NCT00372112|3212794|Superiority||Mean Difference (Net)|3.29|||||2-Sided|95.0|-3.58|10.15||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 14.|
1748386|NCT00372112|3212794|Superiority||Mean Difference (Net)|6.78|||||2-Sided|95.0|-0.11|13.66||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 14.|
1748387|NCT00372112|3212794|Superiority||Mean Difference (Net)|-1.09|||||2-Sided|95.0|-7.16|4.97||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 14.|
1748388|NCT00372112|3212794|Superiority||Mean Difference (Net)|3.82|||||2-Sided|95.0|-2.85|10.5||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 8.|
1748389|NCT00372112|3212794|Superiority||Mean Difference (Net)|8.3|||||2-Sided|95.0|1.52|15.08||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 8.|
1748390|NCT00372112|3212794|Superiority||Mean Difference (Net)|0.16|||||2-Sided|95.0|-5.98|6.29||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 8.|
1748391|NCT00372112|3212794|Superiority||Mean Difference (Net)|-1.46|||||2-Sided|95.0|-8.25|5.33||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 7.|
1748392|NCT00372112|3212794|Superiority||Mean Difference (Net)|-0.45|||||2-Sided|95.0|-7.22|6.32||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 7.|
1748393|NCT00372112|3212794|Superiority||Mean Difference (Net)|-4.25|||||2-Sided|95.0|-10.44|1.93||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 7.|
1748394|NCT00372112|3212794|Superiority||Mean Difference (Net)|4.6|||||2-Sided|95.0|-1.45|10.65||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 2.|
1748395|NCT00372112|3212794|Superiority||Mean Difference (Net)|4.36|||||2-Sided|95.0|-1.57|10.29||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 2.|
1748396|NCT00372112|3212794|Superiority||Mean Difference (Net)|-0.38|||||2-Sided|95.0|-6.11|5.36||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 2.|
1748397|NCT00372112|3212794|Superiority||Mean Difference (Net)|2.49|||||2-Sided|95.0|-3.35|8.33||||||Placebo versus Salmeterol 50 mcg BD for 0-4 h at Day 1.|
1748398|NCT00372112|3212794|Superiority||Mean Difference (Net)|5.33|||||2-Sided|95.0|-0.41|11.07||||||Placebo versus GW642444 400 mcg once daily for 0-4 h at Day 1.|
1748399|NCT00372112|3212794|Superiority||Mean Difference (Net)|2.11|||||2-Sided|95.0|-3.48|7.7||||||Placebo versus GW642444 100 mcg once daily for 0-4 h at Day 1.|
1748400|NCT00372060|3212798|Superiority or Other||Least-squares Mean Difference|-49.2|Standard Error of the Mean|7.7|<|0.001||95.0|-64.5|-33.9|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline 2-hour postprandial glucose.|||
1748401|NCT00372060|3212799|Superiority or Other||Least-squares Mean Difference|-16.7|Standard Error of the Mean|3.39|<|0.001||95.0|-23.4|-10.0|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline fasting plasma glucose.|||
1748402|NCT00372060|3212800|Superiority or Other||Least-squares Mean Difference|-0.8|Standard Error of the Mean|0.1|<|0.001||95.0|-1.0|-0.6|||ANCOVA|Model terms: treatment, prior oral anti-hyperglycemic medication (except for pioglitazone), and baseline HbA1c.|||
1748403|NCT00371865|3212801|Superiority or Other|||||||0.9|||||||Mixed Models Analysis||||
1748404|NCT00371865|3212802|Superiority or Other|||||||0.26|||||||Mixed Models Analysis||||
1748405|NCT00371865|3212803|Superiority or Other|||||||0.13|||||||Mixed Models Analysis||||
1748406|NCT00371865|3212804|Superiority or Other|||||||0.9|||||||Mixed Models Analysis||||
1748407|NCT00371865|3212805|Superiority or Other|||||||0.27|||||||Mixed Models Analysis||||
1748408|NCT00371683|3212860|Superiority or Other|||||||0.0816||||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Any Bleeding Endpoint.|
1748409|NCT00371683|3212860|Superiority or Other||Risk Difference (RD)|-1.52|||||2-Sided|95.0|-3.18|0.13||||||Adjusted difference of event rates of Any Bleeding. Type of surgery was taken into consideration as a stratification factor.|
1748410|NCT00371683|3212860|Superiority or Other|||||||0.0338|||||||test of equality|For descriptive purposes only, p-values were presented for the test of equality of event rates||Major or Clinically Relevant Non-Major Bleeding endpoint.|
1748411|NCT00371683|3212860|Superiority or Other||Risk Difference (RD)|-1.46|||||2-Sided|95.0|-2.75|-0.17||||||Adjusted difference of event rates of Major or Clinically Relevant Non-Major Bleeding. Type of surgery was taken into consideration as a stratification factor.|
1748412|NCT00371683|3212860|Superiority or Other|||||||0.1709||||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Clinically relevant Non-Major Bleeding endpoint|
1748413|NCT00371683|3212860|Superiority or Other||Risk Difference (RD)|-0.77|||||2-Sided|95.0|-1.87|0.33||||||Adjusted difference of event rates of Clinically Relevant Non-Major Bleeding. Type of surgery was taken into consideration as a stratification factor.|
1748414|NCT00371683|3212860|Superiority or Other|||||||0.0533||||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality|||Major Bleeding Endpoint|
1748415|NCT00371683|3212860|Superiority or Other||Risk Difference (RD)|-0.81|||||2-Sided|95.0|-1.49|-0.14||||||Adjusted difference of event rates of Major Bleeding. Type of surgery was taken into consideration as a stratification factor.|
1748416|NCT00371683|3212861|Superiority or Other||Risk Difference (RD)|-0.13|||||2-Sided|95.0|-0.3|0.05||||||Adjusted difference of event rates of thrombocytopenia. Type of surgery was taken into consideration as a stratification factor.|
1748417|NCT00371683|3212861|Superiority or Other||Risk Difference (RD)|-0.13|||||2-Sided|95.0|-0.3|0.05||||||Adjusted difference of event rates of Stroke. Type of surgery was taken into consideration as a stratification factor.|
1748418|NCT00371683|3212861|Superiority or Other||Risk Difference (RD)|-0.19|||||2-Sided|95.0|-0.46|0.09||||||Adjusted difference of event rates of MI. Type of surgery was taken into consideration as a stratification factor.|
1748419|NCT00371683|3212861|Superiority or Other||Risk Difference (RD)|-0.25|||||2-Sided|95.0|-0.55|0.05||||||Adjusted difference of event rates of MI/Stroke. Type of surgery was taken into consideration as a stratification factor.|
1748420|NCT00371683|3212864|Superiority or Other|||||||0.6145||||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality||||
1748421|NCT00371683|3212864|Superiority or Other||Risk Difference (RD)|-0.83|||||2-Sided|95.0|-3.3|1.63|||||||
1748422|NCT00371683|3212864|Superiority or Other||Risk Ratio (RR)|0.94|||||2-Sided|95.0|0.74|1.2|||||||
1748423|NCT00371683|3212865|Superiority or Other|||||||0.2873||||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality||||
1748424|NCT00371683|3212865|Superiority or Other||Risk Difference (RD)|0.38|||||2-Sided|95.0|-0.3|1.06|||||||
1748425|NCT00371683|3212865|Superiority or Other||Risk Ratio (RR)|1.46|||||2-Sided|95.0|0.72|2.95|||||||
1748426|NCT00371683|3212866|Superiority or Other||Risk Difference (RD)|0.25|||||2-Sided|95.0|-0.47|0.98|||||||
1748427|NCT00371683|3212866|Superiority or Other||Risk Ratio (RR)|1.25|||||2-Sided|95.0|0.65|2.4|||||||
1748428|NCT00371683|3212867|Superiority or Other|||||||0.1578||||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality||||
1748429|NCT00371683|3212867|Superiority or Other||Risk Difference (RD)|0.13|||||2-Sided|95.0|-0.05|0.3|||||||
1748430|NCT00371683|3212868|Superiority or Other|||||||0.9975||||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality||||
1748431|NCT00371683|3212868|Superiority or Other||Risk Difference (RD)|0.0|||||2-Sided|95.0|-0.3|0.3|||||||
1748432|NCT00371683|3212868|Superiority or Other||Risk Ratio (RR)|1.0|||||2-Sided|95.0|0.2|4.93|||||||
1748433|NCT00371683|3212869|Superiority or Other|||||||0.5443|||||||test of equality|For descriptive purposes only, p-values were presented for the test of equality of event rates|||
1748434|NCT00371683|3212869|Superiority or Other||Risk Difference (RD)|0.28|||||2-Sided|95.0|-0.78|1.33|||||||
1748435|NCT00371683|3212869|Superiority or Other||Risk Ratio (RR)|1.19|||||2-Sided|95.0|0.68|2.11|||||||
1748436|NCT00371683|3212870|Superiority or Other|||||||0.77||||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality||||
1748437|NCT00371683|3212870|Superiority or Other||Risk Difference (RD)|0.11|||||2-Sided|95.0|-0.99|1.21|||||||
1748438|NCT00371683|3212870|Superiority or Other||Risk Ratio (RR)|1.08|||||2-Sided|95.0|0.63|1.87|||||||
1748439|NCT00371683|3212871|Superiority or Other|||||||0.2626||||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality||||
1748440|NCT00371683|3212871|Superiority or Other||Risk Difference (RD)|0.53|||||2-Sided|95.0|-0.47|1.52|||||||
1748441|NCT00371683|3212871|Superiority or Other||Risk Ratio (RR)|1.41|||||2-Sided|95.0|0.77|2.6|||||||
1748442|NCT00371683|3212872|Superiority or Other|||||||0.7754||||||For descriptive purposes only, p-values were presented for the test of equality of event rates|test of equality||||
1748443|NCT00371683|3212872|Superiority or Other||Risk Difference (RD)|0.28|||||2-Sided|95.0|-2.04|2.59|||||||
1748444|NCT00371683|3212872|Superiority or Other||Risk Ratio (RR)|1.04|||||2-Sided|95.0|0.8|1.35|||||||
1748445|NCT00371683|3212873|Superiority or Other|||||||0.7779|||||||t-test, 1 sided||||
1748446|NCT00371683|3212873|Superiority or Other||Risk Difference (RD)|0.36|||||2-Sided|95.0|-0.68|1.4|||||||
1748447|NCT00371683|3212873|Superiority or Other||Risk Ratio (RR)|1.25|||||2-Sided|95.0|0.7|2.23|||||If the upper bound of the two-sided 95% CI for the Relative Risk was < 1 then superiority for the key secondary efficacy endpoint was demonstrated.||
1748448|NCT00371683|3212874|Non-Inferiority or Equivalence|Two criteria were to be met to demonstrate non-inferiority: the upper bound of the 95% CI for the relative risk should be < 1.25, and the upper bound of the 95% CI for the risk difference should be < 5.6%.|Risk Difference (RD)|0.11|||<|0.0001|2-Sided|95.0|-2.22|2.44||If p-value is less than 0.025, it is statistically significant.|t-test, 1 sided||||
1748449|NCT00371683|3212874|Non-Inferiority or Equivalence|Two criteria were to be met to demonstrate non-inferiority: the upper bound of the 95% confidence interval (CI) for the Relative Risk should be < 1.25, and the upper bound of the 95% CI for the risk difference should be < 5.6%.|Risk Ratio (RR)|1.02|||<|0.0635|2-Sided|95.0|0.78|1.32||If p-value is less than 0.025, it is statistically significant.|t-test, 1 sided||||
1749079|NCT00363415|3213901|Superiority or Other||Hazard Ratio (HR)|1.56|||<|0.01||95.0|1.27|1.92|||Log Rank||||
1748450|NCT00371566|3212910|Superiority or Other||Mean Difference (Net)|-1.7|Standard Deviation|1.93||0.394||95.0|-5.5|2.19|||ANCOVA|Null hypothesis or reject it in favor of the two sided alternative hypothesis||The study was designed to provide evidence to support the null hypothesis: Delta equals 0% or reject it in favor of the two sided alternative hypothesis: Delta does not equal 0%, where Delta was the difference in the true response rate for the two treatment groups.|
1748451|NCT00371540|3212911|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1748452|NCT00371540|3212912|Superiority or Other|||||||1|||||||Fisher Exact||||
1748453|NCT00371540|3212913|Superiority or Other|||||||0.65|||||||Fisher Exact|||Note: The differences between the number of individuals evaluable for this secondary outcome and the number of individuals evaluable for the primary outcome is related to specimen loss by the laboratory. As such of the Routine care group only 96 of 102 patients completing the study were evaluable for the viral load outcome and only 86 of 87 patients in the Home visit group.|
1748454|NCT00371397|3212935|Superiority or Other||Odds Ratio (OR)|4.75||||0.009||95.0|||||Regression, Logistic|||hsCRP dichotomized as undetectable/detectable. Logistic regression w/generalized estimating equations(GEE)s to determine odds ratio. Assessed hsCRP at baseline at each of the three visits; 43% of the values (n = 65) were below the assay’s detectable lower bound of .3 mg/dL, and thus hsCRP was dichotomized as undetectable/detectable.|
1748455|NCT00371267|3212960|Superiority or Other|||||||0.67|||||||Mixed Models Analysis||||
1748456|NCT00371267|3212961|Superiority or Other|||||||0.39|||||||Mixed Models Analysis||||
1748457|NCT00371267|3212962|Superiority or Other||||||<|0.74|||||||Mixed Models Analysis||||
1748458|NCT00371267|3212963|Superiority or Other||||||<|0.35|||||||Mixed Models Analysis||||
1748459|NCT00371267|3212964|Superiority or Other||||||<|0.27|||||||Mixed Models Analysis||||
1748460|NCT00371137|3213014|Superiority or Other|||||||0.015|||||||Chi-squared|||Pairwise comparison of placebo and Xyrem 6.0g|
1748461|NCT00371137|3213014|Superiority or Other||||||<|0.001|||||||Chi-squared|||Pairwise comparison of placebo and Xyrem 4.5g|
1748462|NCT00371137|3213014|Superiority or Other||||||>|0.001|||||||Chi-squared|||Overall Comparison|
1748463|NCT00370994|3213015|Superiority or Other (legacy)|||||||0.001||||||There were significant differences in Oswestry Disability Index between both groups|Repeated measures of ANOVA||||
1748464|NCT00370994|3213016|Superiority or Other (legacy)||||||<|0.001||||||Comparisons were made between groups and within the group between baseline and different time points.|Repeated measures ANOVA.||||
1748465|NCT00370396|3213061|Non-Inferiority or Equivalence|Standardized asymptotic 95% confidence interval (CI) for the difference [Synflorix-Synflorix minus Prevenar-Prevenar] in terms of percentages of subjects reporting rectal fever >39.0°C was computed.|Difference in percentage|-4.43|||||2-Sided|95.0|-11.85|-0.21||||||Analysis aimed at demonstrating the non-inferiority of Synflorix™ vs Prevenar™ vaccine, both co-administered with Infanrix hexa™ vaccine, in terms of post-immunization febrile reactions with rectal fever > 39.0°C.|
1748466|NCT00370331|3213071|Superiority or Other||Odds Ratio (OR)|8.2|||<|0.001||99.0|3.59|18.73|||Repeated measures model for binary data|Repeated measures model for binary data using Generalized Estimating Equations (GEE)|||
1748467|NCT00370292|3213072|Superiority or Other||||||<|0.001||||||P-value for 48 Hours Post-Dose (48 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance||||
1748468|NCT00370292|3213072|Superiority or Other||||||<|0.001||||||P-value for 24 Hours Post-Dose (24 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance||||
1748469|NCT00370292|3213072|Superiority or Other||||||<|0.849||||||P-value for 6 Hours Post-Dose (6 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance||||
1748470|NCT00370292|3213072|Superiority or Other||||||<|0.333||||||P-value for 4 Hours Post-Dose (4 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance||||
1748471|NCT00370292|3213072|Superiority or Other||||||<|0.001||||||P-value for 2 Hours Post-Dose (2 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance||||
1748472|NCT00370292|3213072|Superiority or Other||||||<|0.001||||||P-value for 1 Hour Post-Dose (1 hour across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance||||
1748473|NCT00370292|3213074|Superiority or Other||||||<|0.001||||||P-value for 48 Hours Post-Dose (48 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance||||
1748474|NCT00370292|3213074|Superiority or Other||||||<|0.001||||||P-value for 24 Hours Post-Dose (24 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance||||
1748475|NCT00370292|3213074|Superiority or Other||||||<|0.166||||||P-value for 6 Hours Post-Dose (6 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance||||
1748476|NCT00370292|3213074|Superiority or Other||||||<|0.03||||||P-value for 4 Hours Post-Dose (4 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance||||
1748477|NCT00370292|3213074|Superiority or Other||||||<|0.001||||||P-value for 2 Hours Post-Dose (2 hours across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance||||
1748478|NCT00370292|3213074|Superiority or Other||||||<|0.001||||||P-value for 1 Hour Post-Dose (1 hour across cycles compared with pre-dose across cycles).|Repeated Measures Analysis of Variance||||
1748479|NCT00370071|3213086|Superiority or Other||||||=|0|||||||Wilcoxon-Signed-Rank test|||Lesion volume at Week 24. 37 subjects were evaluated.|
1748480|NCT00370071|3213086|Superiority or Other||||||<|0.0001|||||||Wilcoxon-Signed-Rank test|One-sided p-value from Wilcoxon-Signed-Rank-Test for comparing the baseline visit to treatment visits||Lesion volume at Week 12. 38 subjects were evaluated.|
1748481|NCT00370071|3213087|Superiority or Other|||||||0.0017||||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test||||
1748482|NCT00370071|3213088|Superiority or Other||||||<|0.0001||||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test||||
1748517|NCT00369382|3213253|Superiority or Other||||||<|0.031||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 4|
1749080|NCT00363311|3213916|Superiority or Other|||||||0.12|||||||Fisher Exact||||
1748483|NCT00370071|3213089|Superiority or Other||||||<|0.0001||||||one-sided p-value (one-sided test level 2.5%)|Wilcoxon-Signed-Rank test|||In this single arm study, the number of newly active lesions per 3 months during treatment was compared to the number of newly active lesions during 3-month pre-treatment (Alternative hypothesis: Number of lesions is reduced during treatment with Interferon beta-1b). The sample size was calculated for the use of the one-sided Wilcoxon-Signed-Rank test at level 2.5% (Power of 90% - anticipating P(X&lt;Y)=0.15 and allowing for 25% exclusion from Per Protocol Set).|
1748484|NCT00370032|3213092|Superiority or Other||Mean Difference (Final Values)|-9.11||||0.131||95.0|-21.2|2.997|||paired t-test Hommel-Simes||||
1748485|NCT00370032|3213092|Superiority or Other||Mean Difference (Final Values)|-8.1||||0.131||95.0|-18.4|2.157|||paired t-test Hommel-Simes||||
1748486|NCT00369928|3213172|Superiority or Other||Odds Ratio, log|0.79||||0.666|2-Sided|80.0|0.5|1.25|||Cochran-Mantel-Haenszel||||
1748487|NCT00369928|3213172|Superiority or Other||Odds Ratio, log|0.88||||0.982|2-Sided|80.0|0.56|1.38|||Cochran-Mantel-Haenszel||||
1748488|NCT00369785|3213190|Superiority or Other (legacy)|||||||0.007||||||Not adjusted for multiple comparisons.|Mixed Models Analysis|||Null Hypothesis: No difference in discrimination memory between the two groups|
1748489|NCT00369785|3213191|Superiority or Other (legacy)|||||||0.62||||||Not adjusted for multiple comparisons.|Mixed Models Analysis|||Null Hypothesis: No difference in immediate recall memory at 24 weeks|
1748490|NCT00369668|3213213|Superiority or Other||Mean Difference (Final Values)|30.0|Standard Error of the Mean|3.65|<|0.05|2-Sided|95.0|22.5|37.4|||Mixed Models Analysis|Greenhouse-Geisser degrees of freedom adjustment was not necessary.||Group by Test Session ANOVA with repeated measures on second factor.|
1748491|NCT00369577|3213227|Superiority|||||||0.0001|||||||Fisher Exact||||
1748492|NCT00369577|3213227|Superiority|||||||0.0076|||||||Fisher Exact||||
1748493|NCT00369577|3213228|Superiority|||||||0.0003|||||||Wilcoxon (Mann-Whitney)||||
1748494|NCT00369577|3213228|Superiority|||||||0.0067|||||||Wilcoxon (Mann-Whitney)||||
1748495|NCT00369577|3213229|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1748496|NCT00369577|3213229|Superiority||||||<|0.0583|||||||Wilcoxon (Mann-Whitney)||||
1748497|NCT00369577|3213230|Superiority|||||||0.0002||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA||||
1748498|NCT00369577|3213230|Superiority|||||||0.088||||||p-values (adjusted) using Dunnett's t-test in main effects ANCOVA model|ANCOVA||||
1748499|NCT00369486|3213240|Superiority or Other|||||||0.94|||||||repeated measures least sq. regression|Adjusted for baseline values and for the correlated data from subjects with two study eyes.||Comparison of the mean change in visual acuity letter score among the five groups at 34 weeks. Negative changes represent a worsening in visual acuity.|
1748500|NCT00369486|3213241|Superiority or Other||Odds Ratio (OR)|1.2||||0.63||95.0|0.5|2.9|||generalized estimating equations|||Analysis combined posterior and anterior injection only groups to compare with laser only treatment group.|
1748501|NCT00369486|3213241|Superiority or Other||Odds Ratio (OR)|0.5||||0.04||95.0|0.2|1.0|||generalized estimating equations|||Analysis combined posterior and anterior injection + laser groups to compare with laser only.|
1748502|NCT00369486|3213242|Superiority or Other|||||||0.46||||||Adjusted for baseline central subfield thickness|repeated measures least sq. regression|Models adjusted for baseline values and for correlated data from subjects with two study eyes.||Comparison of change in central subfield thickening from baseline to 34 weeks in all five groups.|
1748503|NCT00369382|3213247|Superiority or Other|||||||0.476||||||alpha is unadjusted|Fisher Exact|||Standard of Care Biopsy-Confirmed Acute Rejection compared between treatment groups|
1748504|NCT00369382|3213247|Superiority or Other|||||||0.206||||||alpha is unadjusted|Fisher Exact|||For-cause Biopsy-Confirmed Acute Rejection compared between treatment groups|
1748505|NCT00369382|3213249|Superiority or Other||slope difference (CNI - SRL)|-2.311||||0.126|2-Sided|95.0|-5.282|0.66||alpha is unadjusted|Random coefficient model||Random coefficient model with each participant's creatinine clearance function of time on treatment; intra-subject regression coefficients considered random.||
1748506|NCT00369382|3213251|Superiority or Other|||||||0.001||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 52|
1748507|NCT00369382|3213251|Superiority or Other|||||||0.121||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 40|
1748508|NCT00369382|3213251|Superiority or Other|||||||0.03||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 32|
1748509|NCT00369382|3213251|Superiority or Other|||||||0.002||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 24|
1748510|NCT00369382|3213251|Superiority or Other||||||<|0.001||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 16|
1748511|NCT00369382|3213251|Superiority or Other||||||<|0.009||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline serum creatinine as a covariate and treatment group and center as factors||Change from baseline to Week 4|
1748512|NCT00369382|3213253|Superiority or Other|||||||0.01||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 52|
1748513|NCT00369382|3213253|Superiority or Other|||||||0.295||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 40|
1748514|NCT00369382|3213253|Superiority or Other|||||||0.151||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 32|
1748515|NCT00369382|3213253|Superiority or Other|||||||0.02||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 24|
1748516|NCT00369382|3213253|Superiority or Other||||||<|0.001||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (MDRD) as a covariate and treatment group and center as factors||Change from baseline to Week 16|
1748518|NCT00369382|3213254|Superiority or Other|||||||0.175||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 40|
1748519|NCT00369382|3213254|Superiority or Other|||||||0.072||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 32|
1748520|NCT00369382|3213254|Superiority or Other|||||||0.012||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 24|
1748521|NCT00369382|3213254|Superiority or Other||||||<|0.001||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 16|
1748522|NCT00369382|3213254|Superiority or Other||||||<|0.018||||||alpha is unadjusted|ANCOVA|ANCOVA with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 4|
1748523|NCT00369382|3213256|Superiority or Other|||||||0.004||||||two-sided alpha = 0.05|ANCOVA|Analysis of covariance (ANCOVA) with baseline creatinine clearance (Cockcroft-Gault) as a covariate and treatment group and center as factors||Change from baseline to Week 52|
1748524|NCT00369343|3213257|Superiority or Other|||||||0.034||||||t-test adjusted by multiple comparison|t-test, 2 sided|||200mg vs. Placebo (0mg) post taper|
1748525|NCT00369343|3213257|Superiority or Other|||||||0.553||||||t-test adjusted by multiple comparison|t-test, 2 sided|||100mg vs. Placebo (0mg) post taper|
1748526|NCT00369343|3213264|Superiority or Other||Mean Difference (Net)|-0.12|||<|0.001||95.0|-0.18|-0.06||Mixed Model Repeated Measures (MMRM) with treatment and site as factors and baseline as covariate.|Mixed Models Analysis||Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.||
1748527|NCT00369343|3213265|Superiority or Other||Mean Difference (Net)|2.74|||<|0.001||95.0|1.24|4.23||Mixed model Repeated Measures (MMRM) analysis adjusted mean score for baseline score, time and center.|Mixed Models Analysis||Adjusted mean difference = Placebo adjusted mean score minus DVS SR adjusted mean score.||
1748528|NCT00369343|3213266|Superiority or Other||Odds Ratio (OR)|3.125|||<|0.001||95.0|1.85|5.27||DVS SR compared with Placebo.|Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariate.|Adjusted odds ratio of DVS SR to Placebo. Odd ratio adjusted for baseline, treatment and site.||
1748529|NCT00369343|3213267|Superiority or Other||Odds Ratio (OR)|2.132||||0.008||95.0|1.22|3.74||DVS SR compared with Placebo.|Chi-squared|Logistic regression model with treatment and site as factors and baseline score as a covariate.|Adjusted odds ratio of DVS SR to Placebo. Odds ratio adjusted for baseline, treatment and site.||
1748530|NCT00369343|3213268|Superiority or Other||||||<|0.001||||||DVS SR compared to Placebo for CGI-I scores of either 1 (very much improved) or 2 (much improved).|Cochran-Mantel-Haenszel||||
1748531|NCT00369343|3213269|Superiority or Other||Mean Difference (Final Values)|4.32|||<|0.001||95.0|2.53|6.11|||Mixed Models Analysis|Mixed Models Repeated Measures (MMRM) used baseline as a covariate and factors for center, week and treatment.|DVS SR adjusted mean change minus placebo adjusted mean change.||
1748532|NCT00369122|3213302|Other||||||||||||||||||Based on a report by Laciano, et al. an SAE rate of 5% and AE rate of 35% were considered tolerable and an SAE rate >=20% and AE rate >=55% excessive. If there were >=6 pts with SAES or >=22 pts with AEs then the treatment would be rejected. This study design provides alpha of 0.05 and power of 90%.
1748533|NCT00368979|3213311|Superiority or Other||Mean Difference (Net)|-1.6||||0.003||95.0|-2.7|-0.5|||ANCOVA||||
1748534|NCT00368966|3213312|Superiority or Other||Difference|1.5||||||95.0|-0.4|3.4||||||For serotype 19A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated|
1748535|NCT00368966|3213312|Superiority or Other||Difference|1.5||||||95.0|-0.1|3.1||||||For serotype 7F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated|
1748536|NCT00368966|3213312|Superiority or Other||Difference|13.0||||||95.0|8.6|17.2||||||For serotype 6A, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated|
1748537|NCT00368966|3213312|Superiority or Other||Difference|10.0||||||95.0|5.9|13.9||||||For serotype 5, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated|
1748538|NCT00368966|3213312|Superiority or Other||Difference|2.2||||||95.0|-1.8|6.3||||||For serotype 3, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated|
1748539|NCT00368966|3213312|Superiority or Other||Difference|3.0||||||95.0|0.8|5.1||||||For serotype 1, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated|
1748540|NCT00368966|3213312|Superiority or Other||Difference|26.5||||||95.0|20.7|31.9||||||For serotype 23F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated|
1748541|NCT00368966|3213312|Superiority or Other||Difference|1.5||||||95.0|-0.4|3.4||||||For serotype 19F, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated|
1748542|NCT00368966|3213312|Superiority or Other||Difference|6.4||||||95.0|3.1|9.5||||||For serotype 18C, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated|
1748543|NCT00368966|3213312|Superiority or Other||Difference|-1.1||||||95.0|-3.4|1.2||||||For serotype 14, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated|
1748544|NCT00368966|3213312|Superiority or Other||Difference|7.3||||||95.0|4.1|10.4||||||For serotype 9V, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated|
1748545|NCT00368966|3213312|Superiority or Other||Difference|41.2||||||95.0|34.9|46.9||||||For serotype 6B, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated|
1748546|NCT00368966|3213312|Superiority or Other||Difference|2.2||||||95.0|0.1|4.4||||||For serotype 4, the difference in percentages between the two groups (13vPnC After Infant Series Dose 2 - 13vPnC After Infant Series Dose 3) was calculated|
1748547|NCT00368966|3213313|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.89||||||95.0|0.78|1.02||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated|
1748548|NCT00368966|3213313|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.88|1.15||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated|
1748549|NCT00368966|3213313|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.88|1.14||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated|
1748550|NCT00368966|3213313|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.05||||||95.0|0.92|1.18||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated|
1748551|NCT00368966|3213313|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.07||||||95.0|0.96|1.2||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated|
1748552|NCT00368966|3213313|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.93|1.13||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated|
1748553|NCT00368966|3213314|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.12||||||95.0|0.9|1.4||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated|
1748554|NCT00368966|3213314|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.71|1.02||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated|
1748555|NCT00368966|3213314|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.88|1.2||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated|
1748556|NCT00368966|3213314|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.75|0.96||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated|
1748557|NCT00368966|3213315|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.07||||||95.0|0.88|1.29||||||For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated|
1748558|NCT00368966|3213315|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.9||||||95.0|0.75|1.09||||||For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated|
1748559|NCT00368966|3213315|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.82||||||95.0|0.69|0.98||||||For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated|
1748560|NCT00368966|3213315|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.95||||||95.0|0.76|1.19||||||For Poliovirus Type 3 the GMT ratio (13vPnC/7vPnC) was calculated|
1748561|NCT00368966|3213315|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.76|1.18||||||For Poliovirus Type 2 the GMT ratio (13vPnC/7vPnC) was calculated|
1748562|NCT00368966|3213315|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.0||||||95.0|0.82|1.23||||||For Poliovirus Type 1 the GMT ratio (13vPnC/7vPnC) was calculated|
1748563|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0|||||2-Sided|95.0|-1.5|1.5||||||For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated|
1748564|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.4|||||2-Sided|95.0|-1.1|2.2||||||For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated|
1748565|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0|||||2-Sided|95.0|-1.5|1.5||||||For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 EU/mL threshold was calculated|
1748566|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.4|||||2-Sided|95.0|-1.0|2.0||||||For Poliovirus Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated|
1748609|NCT00368940|3213323|Superiority||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1748610|NCT00368940|3213324|Superiority|||||||0.0268|||||||Wilcoxon (Mann-Whitney)||||
1748567|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.7|||||2-Sided|95.0|-0.6|2.6||||||For Poliovirus Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated|
1748568|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0|||||2-Sided|95.0|-1.4|1.3||||||For Poliovirus Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated|
1748569|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0|||||2-Sided|95.0|-1.8|1.7||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated|
1748570|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.8|||||2-Sided|95.0|-2.1|3.8||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated|
1748571|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0|||||2-Sided|95.0|-1.3|1.3||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated|
1748572|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.4|||||2-Sided|95.0|-2.1|2.9||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated|
1748573|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0|||||2-Sided|95.0|-1.5|1.5||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated|
1748574|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-0.8|||||2-Sided|95.0|-2.8|0.8||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated|
1748575|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0|||||2-Sided|95.0|-1.3|1.3||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated|
1748576|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-0.7|||||2-Sided|95.0|-2.5|0.7||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.10 IU/mL threshold was calculated|
1748577|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-1.7||||||95.0|-5.8|2.3||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 69 EU/mL threshold was calculated|
1748578|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated|
1748579|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-0.6||||||95.0|-4.6|3.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 99 EU/mL threshold was calculated|
1748580|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated|
1748581|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated|
1748582|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-1.4||||||95.0|-5.1|2.2||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 11 EU/mL threshold was calculated|
1748583|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.7|1.7||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated|
1748584|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-0.6||||||95.0|-4.4|3.2||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 39 EU/mL threshold was calculated|
1748585|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated|
1748611|NCT00368940|3213325|Superiority||Cohen D at week 12|0.67||||0.001|2-Sided|95.0|0.2|1.14|||Mixed Models Analysis||||
1748586|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-1.3||||||95.0|-5.2|2.6||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 64 EU/mL threshold was calculated|
1748587|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated|
1748588|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated|
1748589|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-1.9||||||95.0|-6.0|2.0||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated|
1748590|NCT00368966|3213316|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Pertussis, PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5.0 EU/mL threshold was calculated|
1748591|NCT00368966|3213317|Superiority or Other||Difference|1.3||||||95.0|1.18|1.44||||||For serotype 19A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.|
1748592|NCT00368966|3213317|Superiority or Other||Difference|2.18||||||95.0|1.98|2.41||||||For serotype 7F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.|
1748593|NCT00368966|3213317|Superiority or Other||Difference|2.87||||||95.0|2.58|3.2||||||For serotype 6A, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.|
1748594|NCT00368966|3213317|Superiority or Other||Difference|1.94||||||95.0|1.78|2.11||||||For serotype 5, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.|
1748595|NCT00368966|3213317|Superiority or Other||Difference|1.23||||||95.0|1.13|1.35||||||For serotype 3, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.|
1748596|NCT00368966|3213317|Superiority or Other||Difference|1.6||||||95.0|1.46|1.76||||||For serotype 1, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.|
1748597|NCT00368966|3213317|Superiority or Other||Difference|4.0||||||95.0|3.55|4.5||||||For serotype 23F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.|
1748598|NCT00368966|3213317|Superiority or Other||Difference|0.93||||||95.0|0.83|1.03||||||For serotype 19F, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.|
1748599|NCT00368966|3213317|Superiority or Other||Difference|1.45||||||95.0|1.3|1.61||||||For serotype 18C, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.|
1748600|NCT00368966|3213317|Superiority or Other||Difference|1.61||||||95.0|1.41|1.83||||||For serotype 14, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.|
1748601|NCT00368966|3213317|Superiority or Other||Difference|1.15||||||95.0|1.05|1.25||||||For serotype 6B, the GMFR were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.|
1748602|NCT00368966|3213317|Superiority or Other||Difference|9.28||||||95.0|8.18|10.53||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748603|NCT00368966|3213317|Superiority or Other||Difference|1.23||||||95.0|1.13|1.35||||||For serotype 4, the Geometric Mean fold Rise (GMFR) were calculated using all participants with available data from both 13vPnC After Infant Series Dose 2 and 13vPnC After Infant Series Dose 3 blood draws.|
1748604|NCT00368966|3213320|Non-Inferiority or Equivalence|Non-inferiority for immune response induced by Meningitec was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.81||||||95.0|0.7|0.94||||||For Diphtheria the GMC ratio (13vPnC/7vPnC) was calculated|
1748605|NCT00368966|3213321|Non-Inferiority or Equivalence|Non-inferiority for immune response induced by Meningitec was declared if the lower bound of the 2-sided, 95% CI for the GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.6|0.86||||||For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated|
1748606|NCT00368966|3213322|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.3|1.3||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.01 IU/mL threshold was calculated|
1748607|NCT00368966|3213322|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|1.2||||||95.0|-2.3|4.9||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 0.10 IU/mL threshold was calculated|
1748608|NCT00368966|3213322|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (>) -10%.|Difference|-0.6||||||95.0|-2.9|1.6||||||For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 1:8 threshold was calculated|
1748613|NCT00368927|3213327|Superiority or Other|||||||0.63|||||||t-test, 2 sided|||A sample size of 60 participants per intervention arm would provide 90% power and 80% power to detect effect sizes of 60% and 52%, respectively, using a two-sample t-test(alpha=0.05).|
1748614|NCT00368927|3213328|Superiority or Other|||||||0.85|||||||Fisher Exact|||With a sample size of 60 evaluable participants per intervention arm, we would have 90% power to detect a bronchial dysplasia response rate of 54% and 82% power to detect a bronchial dysplasia response rate of > 51% among participants assigned to receive active sulindac (2-sided chi-square test with continuity correction; alpha=0.05).|
1748615|NCT00368849|3213334|Superiority or Other||Mean Difference (Final Values)|0.77||||0.76|||||||ANCOVA|||The secondary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.|
1748616|NCT00368849|3213335|Superiority or Other||Mean Difference (Final Values)|0.44||||0.84|||||||ANCOVA|||The secondary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.|
1748617|NCT00368849|3213336|Superiority or Other||Mean Difference (Final Values)|1.26||||0.46|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.|
1748618|NCT00368849|3213337|Superiority or Other||Mean Difference (Final Values)|-0.15||||0.09|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.|
1748619|NCT00368849|3213338|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.63|||||||ANCOVA|||The primary measures were analyzed as pretreatment and posttreatment difference scores using a series of analyses of covariance controlling for age. The results were screened for model violations (e.g., outliers). Preliminary analyses assured no treatment order effects by examining block by treatment interactions.|
1748620|NCT00368745|3213339|Superiority or Other|||||||0.1159||||||p-value is obtained using Cochran-Mantel-Haenszel option|Cochran-Mantel-Haenszel||||
1748621|NCT00368745|3213340|Superiority or Other|||||||0.0148||||||p-value is from the log-rank statistic from the tests for equality over treatment as strata and country used as covariate|Log Rank||||
1748622|NCT00368745|3213341|Superiority or Other|||||||0.0626||||||p-value is from the log-rank statistic from the tests for equality over treatment as strata and country used as covariate|Log Rank||||
1748623|NCT00368745|3213342|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|2.68||0.8897||95.0|-5.74|4.99||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as the covariate|||
1748624|NCT00368745|3213343|Superiority or Other||Mean Difference (Final Values)|-1.03|Standard Error of the Mean|0.39||0.0096||95.0|-1.8|-0.26||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint [LOCF]|
1748625|NCT00368745|3213343|Superiority or Other||Mean Difference (Final Values)|-0.96|Standard Error of the Mean|0.43||0.0328||95.0|-1.83|-0.08||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6|
1748626|NCT00368745|3213343|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.42||0.37||95.0|-1.23|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5|
1748627|NCT00368745|3213343|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.39||0.4341||95.0|-1.08|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4|
1748628|NCT00368745|3213343|Superiority or Other||Mean Difference (Final Values)|-0.64|Standard Error of the Mean|0.35||0.0707||95.0|-1.33|0.06||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3|
1748629|NCT00368745|3213343|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.33||0.0717||95.0|-1.26|0.06||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2|
1748630|NCT00368745|3213343|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.32||0.1252||95.0|-1.14|0.14||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1|
1748631|NCT00368745|3213343|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.61||0.476||95.0|-1.73|0.84||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6|
1748632|NCT00368745|3213343|Superiority or Other||Mean Difference (Final Values)|-0.85|Standard Error of the Mean|0.66||0.2409||95.0|-2.41|0.72||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5|
1748633|NCT00368745|3213343|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.58||0.8232||95.0|-1.07|1.34||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4|
1748634|NCT00368745|3213343|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.35||0.2827||95.0|-1.07|0.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3|
1748635|NCT00368745|3213343|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.34||0.0099||95.0|-1.58|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2|
1748636|NCT00368745|3213343|Superiority or Other||Mean Difference (Final Values)|-0.66|Standard Error of the Mean|0.28||0.0226||95.0|-1.22|-0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1|
1748637|NCT00368745|3213344|Superiority or Other||Mean Difference (Final Values)|-0.95|Standard Error of the Mean|0.36||0.0109||95.0|-1.67|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint [LOCF]|
1748638|NCT00368745|3213344|Superiority or Other||Mean Difference (Final Values)|-0.66|Standard Error of the Mean|0.42||0.1241||95.0|-1.52|0.19||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6|
1748639|NCT00368745|3213344|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.43||0.2702||95.0|-1.35|0.39||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5|
1748640|NCT00368745|3213344|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.38||0.5104||95.0|-1.03|0.52||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4|
1748641|NCT00368745|3213344|Superiority or Other||Mean Difference (Final Values)|-0.78|Standard Error of the Mean|0.34||0.0267||95.0|-1.46|-0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3|
1748642|NCT00368745|3213344|Superiority or Other||Mean Difference (Final Values)|-0.87|Standard Error of the Mean|0.34||0.014||95.0|-1.56|-0.18||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2|
1748643|NCT00368745|3213344|Superiority or Other||Mean Difference (Final Values)|-0.98|Standard Error of the Mean|0.35||0.0063||95.0|-1.67|-0.29||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1|
1748644|NCT00368745|3213344|Superiority or Other||Mean Difference (Final Values)|-0.85|Standard Error of the Mean|0.45||0.0744||95.0|-1.79|0.09||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6|
1748645|NCT00368745|3213344|Superiority or Other||Mean Difference (Final Values)|-0.81|Standard Error of the Mean|0.53||0.1747||95.0|-2.07|0.46||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5|
1748646|NCT00368745|3213344|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.6||0.8991||95.0|-1.17|1.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4|
1748647|NCT00368745|3213344|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|0.38||0.125||95.0|-1.35|0.17||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3|
1748648|NCT00368745|3213344|Superiority or Other||Mean Difference (Final Values)|-0.81|Standard Error of the Mean|0.29||0.0074||95.0|-1.4|-0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2|
1748649|NCT00368745|3213344|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.24||0.126||95.0|-0.86|0.11||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1|
1748650|NCT00368745|3213345|Superiority or Other||Mean Difference (Final Values)|-0.76|Standard Error of the Mean|0.25||0.0031||95.0|-1.26|-0.27||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Endpoint [LOCF]|
1748651|NCT00368745|3213345|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.31||0.3189||95.0|-0.95|0.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 6|
1748652|NCT00368745|3213345|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.27||0.7789||95.0|-0.62|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 5|
1748653|NCT00368745|3213345|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.24||0.914||95.0|-0.51|0.46||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 4|
1748654|NCT00368745|3213345|Superiority or Other||Mean Difference (Final Values)|-0.56|Standard Error of the Mean|0.26||0.0364||95.0|-1.09|-0.04||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 3|
1748655|NCT00368745|3213345|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.25||0.0503||95.0|-0.99|0.0||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 2|
1748656|NCT00368745|3213345|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.2||0.0013||95.0|-1.1|-0.28||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Free (AF) Week 1|
1748657|NCT00368745|3213345|Superiority or Other||Mean Difference (Final Values)|-0.71|Standard Error of the Mean|0.42||0.1074||95.0|-1.58|0.17||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 6|
1748658|NCT00368745|3213345|Superiority or Other||Mean Difference (Final Values)|-0.72|Standard Error of the Mean|0.47||0.1807||95.0|-1.92|0.47||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 5|
1748659|NCT00368745|3213345|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.35||0.3085||95.0|-1.11|0.37||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 4|
1748660|NCT00368745|3213345|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.25||0.0528||95.0|-1.0|0.01||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 3|
1748661|NCT00368745|3213345|Superiority or Other||Mean Difference (Final Values)|-0.74|Standard Error of the Mean|0.18||0.0001||95.0|-1.11|-0.38||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 2|
1748662|NCT00368745|3213345|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.16||0.0052||95.0|-0.76|-0.14||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Taper (AT) Week 1|
1748663|NCT00368745|3213347|Superiority or Other||Mean Difference (Final Values)|-3.8|Standard Error of the Mean|1.48||0.0122||95.0|-6.74|-0.85||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Endpoint [LOCF]|
1748664|NCT00368745|3213347|Superiority or Other||Mean Difference (Final Values)|-3.11|Standard Error of the Mean|1.43||0.0376||95.0|-6.03|-0.19||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 6|
1748665|NCT00368745|3213347|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|1.04||0.7161||95.0|-2.49|1.73||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 5|
1748666|NCT00368745|3213347|Superiority or Other||Mean Difference (Final Values)|0.44|Standard Error of the Mean|1.16||0.7062||95.0|-1.9|2.79||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 4|
1748667|NCT00368745|3213347|Superiority or Other||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|1.06||0.7832||95.0|-2.41|1.83||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 3|
1748668|NCT00368745|3213347|Superiority or Other||Mean Difference (Final Values)|-1.71|Standard Error of the Mean|1.37||0.2185||95.0|-4.47|1.05||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AF Week 2|
1748669|NCT00368745|3213347|Superiority or Other||Mean Difference (Final Values)|-3.92|Standard Error of the Mean|1.4||0.0069||95.0|-6.73|-1.12||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Free (AF) Week 1|
1748670|NCT00368745|3213347|Superiority or Other||Mean Difference (Final Values)|-5.73|Standard Error of the Mean|2.02||0.0104||95.0|-9.96|-1.51||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 6|
1748671|NCT00368745|3213347|Superiority or Other||Mean Difference (Final Values)|-2.28|Standard Error of the Mean|2.67||0.4263||95.0|-8.82|4.26||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 5|
1748672|NCT00368745|3213347|Superiority or Other||Mean Difference (Final Values)|-3.41|Standard Error of the Mean|1.52||0.0357||95.0|-6.57|-0.25||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 4|
1748673|NCT00368745|3213347|Superiority or Other||Mean Difference (Final Values)|-2.85|Standard Error of the Mean|1.73||0.1048||95.0|-6.32|0.62||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 3|
1748674|NCT00368745|3213347|Superiority or Other||Mean Difference (Final Values)|-3.63|Standard Error of the Mean|1.26||0.0053||95.0|-6.15|-1.11||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||AT Week 2|
1748675|NCT00368745|3213347|Superiority or Other||Mean Difference (Final Values)|-2.18|Standard Error of the Mean|1.4||0.122||95.0|-4.97|0.6||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country as covariate||Alprazolam Taper (AT) Week 1|
1748676|NCT00368745|3213350|Superiority or Other||Mean Difference (Final Values)|-4.79|Standard Error of the Mean|1.37||0.0008||95.0|-7.51|-2.07||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Endpoint [LOCF]|
1748677|NCT00368745|3213350|Superiority or Other||Mean Difference (Final Values)|-0.85|Standard Error of the Mean|1.35||0.5337||95.0|-3.62|1.91||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 6|
1748678|NCT00368745|3213350|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|1.26||0.6873||95.0|-3.07|2.05||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 5|
1748679|NCT00368745|3213350|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|1.15||0.9966||95.0|-2.31|2.32||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 4|
1748680|NCT00368745|3213350|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|1.14||0.3868||95.0|-3.29|1.3||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 3|
1748681|NCT00368745|3213350|Superiority or Other||Mean Difference (Final Values)|-1.01|Standard Error of the Mean|1.18||0.3924||95.0|-3.38|1.35||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AF Week 2|
1748682|NCT00368745|3213350|Superiority or Other||Mean Difference (Final Values)|-2.83|Standard Error of the Mean|1.11||0.0135||95.0|-5.05|-0.61||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Free (AF) Week 1|
1749081|NCT00363311|3213917|Superiority or Other|||||||0.8|||||||Wilcoxon (Mann-Whitney)||||
1749082|NCT00363311|3213919|Superiority or Other|||||||0.039|||||||Wilcoxon (Mann-Whitney)||||
1748683|NCT00368745|3213350|Superiority or Other||Mean Difference (Final Values)|-3.68|Standard Error of the Mean|2.04||0.0882||95.0|-7.96|0.61||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 6|
1748684|NCT00368745|3213350|Superiority or Other||Mean Difference (Final Values)|-5.22|Standard Error of the Mean|3.04||0.1371||95.0|-12.67|2.23||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT week 5|
1748685|NCT00368745|3213350|Superiority or Other||Mean Difference (Final Values)|-3.38|Standard Error of the Mean|1.92||0.092||95.0|-7.37|0.6||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 4|
1748686|NCT00368745|3213350|Superiority or Other||Mean Difference (Final Values)|-2.38|Standard Error of the Mean|1.3||0.0718||95.0|-4.98|0.22||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 3|
1748687|NCT00368745|3213350|Superiority or Other||Mean Difference (Final Values)|-3.89|Standard Error of the Mean|1.08||0.0006||95.0|-6.04|-1.74||contrasts performed using Dunnett's Test|ANCOVA|LS Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||AT Week 2|
1748688|NCT00368745|3213350|Superiority or Other||Mean Difference (Final Values)|-1.48|Standard Error of the Mean|0.81||0.0709||95.0|-3.1|0.13||contrasts performed using Dunnett's Test|ANCOVA|Least squares (LS) Means from the ANCOVA model with treatment as the main effect and country and baseline as covariate||Alprazolam Taper (AT) Week 1|
1748689|NCT00368745|3213351|Superiority or Other|||||||0.2838||||||significance determined using 2-tailed significance level of 0.05|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with country as a covariate||Primary objective: evaluate the efficacy of pregabalin in maintaining the benzodiazepine free state in subjects with prior stable alprazolam use.|
1748690|NCT00368537|3213358|Superiority or Other||Risk Difference (RD)|-1.2||||0.444||95.0|-4.4|2.0|||Fisher Exact|2-sided||Intensive care unit|
1748691|NCT00368537|3213360|Non-Inferiority or Equivalence|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.4||||||95.0|-9.6|14.4|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.|Group comparison of eradication + presumed eradication|
1748692|NCT00368537|3213361|Non-Inferiority or Equivalence|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.2||||||95.0|-9.6|14.0|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.||
1748693|NCT00368537|3213362|Non-Inferiority or Equivalence|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|0.0||||||95.0|-8.7|8.6|||||Confidence interval calculated using asymptotic method corrected for continuity. Difference= Tigecycline minus Ampicillin-Sulbactam or Amoxicillin-Clavulanate.||
1748694|NCT00368459|3213366|Superiority or Other||||||>|0.1|||||||ANCOVA||||
1748695|NCT00368459|3213367|Superiority or Other||||||>|0.1|||||||ANCOVA||||
1748696|NCT00368459|3213368|Superiority or Other||||||<|0.01||||||Favoring placebo, unadjusted for multiple comparisons|ANCOVA||||
1748697|NCT00368459|3213369|Superiority or Other||||||>|0.1|||||||ANCOVA||||
1748698|NCT00368459|3213370|Superiority or Other||||||>|0.1|||||||ANCOVA||||
1748699|NCT00368459|3213371|Superiority or Other||||||>|0.1|||||||ANCOVA||||
1748700|NCT00368459|3213372|Superiority or Other||||||>|0.1|||||||ANCOVA||||
1748701|NCT00368459|3213373|Superiority or Other||||||>|0.1|||||||ANCOVA||||
1748702|NCT00368459|3213374|Superiority or Other||||||>|0.1|||||||ANCOVA||||
1748703|NCT00368459|3213375|Superiority or Other||||||>|0.1|||||||ANCOVA|||For this pilot trial, we did not anticipate power to detect significant, clinically-meaningful between-group differences of the magnitude provided by FDA-approved AD therapies over a 12 month treatment period, but we specified that we would report trends (alpha <0.1) as a guide to future effectiveness studies.|
1748704|NCT00368251|3213392|Superiority or Other||||||=|0||||||The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.|Stratified Wilcoxon test|||P-value for pairwise comparison of each Brivaracetam dose versus Placebo.|
1748705|NCT00368251|3213392|Superiority or Other||||||=|0||||||The Global Evaluation Scale by Investigator (I-GES) was compared between placebo and each dose at 5 % significance level independently from the previous secondary endpoints.|Stratified Wilcoxon test||||
1748706|NCT00368251|3213393|Superiority or Other||Hodges-Lehmann-estimator of difference|10.0|||=|0|2-Sided|95.0|-5.56|30.0||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.||
1748707|NCT00368251|3213393|Superiority or Other||Hodges-Lehmann-estimator of difference|14.29|||=|0|2-Sided|95.0|-1.76|39.39||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.||
1748708|NCT00368251|3213394|Superiority or Other||Hodges-Lehmann-estimator of difference|0.0|||=|0|2-Sided|95.0|-50.0|66.67||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.||
1749083|NCT00363311|3213920|Superiority or Other|||||||0.2|||||||Wilcoxon (Mann-Whitney)||||
1749084|NCT00363311|3213927|Superiority or Other|||||||0.024|||||||Fisher Exact||||
1748709|NCT00368251|3213394|Superiority or Other||Hodges-Lehmann-estimator of difference|0.0|||=|0|2-Sided|95.0|-25.0|100.0||Tested at the 5 % level - given the Functional Disability Score comparing Placebo versus Brivaracetam (BRV) 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Willcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.||
1748710|NCT00368251|3213395|Superiority or Other||Hodges-Lehmann-estimator of difference|0.0|||=|0|2-Sided|95.0|-33.33|18.75||Tested at the 5 % level - given the primary endpoint testing Placebo versus Brivaracetam (BRV) 5 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intevals are obtained from Hodges-Lehmann (unstratified).|Difference versus Placebo.|"In case the three endpoints are significant for placebo versus Brivaracetam (BRV) 150 mg/day, the primary endpoint will be tested for Placebo versus BRV 5 mg/day. In case of significance, the three UMRS related secondary endpoints will be tested for Placebo versus BRV 5 mg/day, provided the previous is significant at 5 %. Secondary endpoints are tested in the following order:~Functional Disability~Stimulus Sensitivity~Myoclonus Patient Questionnaire"|
1748711|NCT00368251|3213395|Superiority or Other||Hodges-Lehmann-estimator of difference|1.24|||=|0|2-Sided|95.0|-21.9|31.06||Tested at the 5 % level - given the Primary Outcome testing Placebo versus BRV 150 mg/day is significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals are obtained from Hodges-Lehmann(unstratified).|Difference versus Placebo.|If primary efficacy is proven for Brivaracetam (BRV) 150 mg/day, the following secondary endpoints will be tested for Placebo versus BRV 150 mg/day. The testing scheme will be hierarchical, thus statistical significance at 5 % on BRV 150 mg/day on a secondary endpoint is needed to continue testing BRV 150 mg/day at 5 % significance level for the next secondary endpoint.|
1748712|NCT00368251|3213396|Superiority or Other||Hodges-Lehmann-estimator of difference|-18.05|||=|0|2-Sided|95.0|-39.31|4.86||Tested at the 5 % level - given the primary endpoint and the three UMRS related secondary endpoints comparing placebo versus Brivaracetam (BRV) 150 mg/day are significant at the 5 % level (hierarchical testing procedure).|stratified Wilcoxon Test|Estimates and confidence intervals from Hodges-Lehmann (unstratified).|Difference versus Placebo.||
1748713|NCT00368251|3213396|Superiority or Other||Hodges-Lehmann-estimator of difference|0.15|||=|0|2-Sided|95.0|-26.12|24.96||All hypotheses are tested at the 5 % level. The multiplicity scheme (hierarchical testing procedure) assures strong control of the type I error at the 5 % level.|stratified Wilcoxon Test|Estimates and confidence intervals from Hodges-Lehmann (unstratified).|Difference versus Placebo was calculated.|"The first hypothesis for the primary efficacy variable compares placebo versus Brivaracetam (BRV) 150 mg/day.~The second hypothesis for the primary efficacy variable compares placebo versus BRV 5 mg/day. However, this second hypothesis will only be tested when all the hypotheses for placebo versus BRV 150 mg/day are significant for the primary three UMRS related secondary endpoints.~The hypotheses will be tested using nonparametric analysis. The study was designed to have 80 % power."|
1748714|NCT00368069|3213401|Superiority or Other||Percent reduction over Placebo|18.6||||||95.0|6.7|28.9||||||Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data|
1748715|NCT00368069|3213401|Superiority or Other||Mean Difference (Net)|0.205||||0.003||95.0|0.07|0.341|||ANCOVA|ANCOVA on (log-) Treatment POS frequency per week with Treatment and (log-) Baseline POS frequency per week as covariate|||
1748716|NCT00368069|3213402|Superiority or Other|||||||0.033|||||||Mantel Haenszel|Subjects with missing data during the Treatment period were considered in the category <-25%.|||
1748717|NCT00368069|3213403|Superiority or Other||Odds Ratio (OR)|1.84||||0.07||95.0|0.95|3.55|||Regression, Logistic|Logistic regression analysis including Treatment as a factor.|Based on the number of evaluable patients. A patient is considered as evaluable for the response status if he has seizure information in at least one of the period (baseline or treatment period.||
1748718|NCT00368069|3213404|Superiority or Other||Percent reduction over Placebo|14.7||||||95.0|1.2|26.3||||||Treatment difference was assessed through the percent reduction in POS frequency per week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data|
1748719|NCT00368069|3213404|Superiority or Other||Mean Difference (Net)|0.158||||0.034||95.0|0.012|0.305|||ANCOVA|ANCOVA on (log-) seizure frequency per week over Treatment period with Treatment, (log-) Baseline seizure frequency per week as covariate.|||
1748720|NCT00368069|3213406|Superiority or Other||Percent reduction over Placebo|14.4||||||95.0|0.9|26.0||||||Treatment difference was assessed through the percent reduction in POS freq/week of Keppra over Placebo by back transformation of the results of the ANCOVA on log data|
1748721|NCT00368069|3213406|Superiority or Other||Mean Difference (Net)|0.155||||0.038||95.0|0.009|0.301|||ANCOVA|Analysis of covariance (ANCOVA) on (log-) POS freq/week over Treatment period with Treatment, (log-) Baseline POS freq/week as covariate.|||
1748722|NCT00367835|3213417|Superiority or Other||||||<|0.001|||||||ANOVA||||
1748723|NCT00367835|3213418|Superiority or Other|||||||0.002|||||||ANCOVA||||
1748724|NCT00367835|3213419|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1748725|NCT00367835|3213420|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1748726|NCT00367835|3213421|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1748727|NCT00367835|3213422|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1748728|NCT00367835|3213423|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1748729|NCT00367744|3213428|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Treatment groups were compared for change in limb fat using a two-sided signed rank test||The primary outcome measure was the change in limb fat at 48 weeks between the rosiglitazone and placebo group.|
1748730|NCT00367679|3213429|Superiority or Other|||||||0.326||||||Vascular endothelial growth factor (VEGF)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment|||
1748731|NCT00367679|3213429|Superiority or Other|||||||0.021||||||Interferon alpha 2 (IFN-alpha2)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment|||
1748732|NCT00367679|3213429|Superiority or Other|||||||0.0093||||||Tumor necrosis factor ligand (TRAIL)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment|||
1748733|NCT00367679|3213429|Superiority or Other|||||||0.0069||||||Monokine induced by interferon gamma (MIG)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment|||
1748734|NCT00367679|3213429|Superiority or Other|||||||0.0062||||||Stromal cell-derived factor 1 (SDF-1alpha)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment|||
1748735|NCT00367679|3213429|Superiority or Other|||||||0.0029||||||Cutaneous T-cell attracting chemokine (CTACK)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment|||
1748736|NCT00367679|3213429|Superiority or Other|||||||0.00024||||||Interferon-inducible cytokine (IP-10)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment|||
1748737|NCT00367679|3213429|Superiority or Other||||||<|0.01||||||Placental growth factor (PIGF)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment|||
1748738|NCT00367679|3213429|Superiority or Other||||||<|0.01||||||Vascular endothelial growth factor receptor 2 (VEGFR2)|Wilcoxon (Mann-Whitney)|Post- versus pretreatment change in levels of cytokines and angiogenic factors in response to pazopanib treatment|||
1748739|NCT00367679|3213435|Superiority or Other|||||||0.0082||||||c-KIT|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment|||
1748740|NCT00367679|3213435|Superiority or Other|||||||0.0082||||||VEGFR-2|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment|||
1748741|NCT00367679|3213435|Superiority or Other|||||||0.0324||||||VEGF A|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment|||
1748742|NCT00367679|3213435|Superiority or Other|||||||0.0028||||||VEGF D|t-test, 2 sided|Post- versus pretreatment expression levels for each of the indicated genes in response to pazopanib treatment|||
1748743|NCT00367679|3213441|Superiority or Other||Percentage of participants with response|8.6||||||95.0|1.8|23.1|||||The estimated value given is the percentage of participants who had a response out of the total participants.||
1748744|NCT00367679|3213442|Superiority or Other||Percentage of participants with response|5.7||||||95.0|0.7|19.2|||||The estimated value given is the percentage of participants who had a response out of the total participants.||
1748745|NCT00367640|3213443|Superiority or Other|||||||0.4606||||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.|
1748746|NCT00367640|3213443|Superiority or Other|||||||0.0001||||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.|
1748747|NCT00367640|3213443|Superiority or Other|||||||0.0006||||||ANCOVA of the average RTSS, with treatment and pooled sites as factors, and retrospective RTSS, asthma and sensitised status as covariates.|ANCOVA|||A step-down approach is performed to address the multiplicity issue.|
1748748|NCT00367237|3213468|Superiority or Other||Proportion of Responders|0.667||||||95.0|||||||||
1748749|NCT00367237|3213468|Superiority or Other||Proportion of Responders|0.863||||||95.0|||||||||
1748750|NCT00367237|3213468|Superiority or Other||Difference in percentages of respondents|19.61||||0.021||95.0|3.27|35.95||Comparison of treatments (IFX + MTX versus MTX)|Chi-squared||Difference in percentages of respondents is (percentage of respondents in IFX+MTX group minus percentage of respondents in MTX group)||
1748751|NCT00367133|3213476|Superiority or Other|||||||0.55|||||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for statistical analysis|
1748752|NCT00367133|3213476|Superiority or Other||||||<|0.001|||||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for statistical analysis|
1748753|NCT00367133|3213476|Superiority or Other||||||<|0.001|||||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons|
1748754|NCT00367133|3213477|Superiority or Other|||||||0.6|||||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for multiple comparisons|
1748755|NCT00367133|3213477|Superiority or Other||||||<|0.001|||||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons|
1748756|NCT00367133|3213477|Superiority or Other||||||<|0.001|||||||GEE Repeated Measures|Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons|
1748757|NCT00367133|3213479|Superiority or Other|||||||0.91|||||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Values not adjusted for multiple comparisons|
1748758|NCT00367133|3213479|Superiority or Other||||||<|0.001|||||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P Value not adjusted for multiple comparisons|
1748759|NCT00367133|3213479|Superiority or Other||||||<|0.001|||||||ANCOVA|Repeated Measures Model. Accounted for correlated data from subjects with 2 study eyes; included baseline central subfield thickness as a covariate.||P value not adjusted for multiple comparisons|
1748760|NCT00367133|3213480|Superiority or Other|||||||0.82|||||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening|
1748761|NCT00367133|3213480|Superiority or Other|||||||0.01|||||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening|
1748762|NCT00367133|3213480|Superiority or Other|||||||0.03|||||||GEE Repeated Measures|Hochberg procedure used to determine statistical significance.||Proportion with 15-letter or more worsening|
1748763|NCT00367133|3213483|Superiority or Other|||||||0.49|||||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P Values for 2 group comparisons of difference in mean change|
1748764|NCT00367133|3213483|Superiority or Other|||||||0.002|||||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P Values for 2 group comparisons of difference in mean change|
1748765|NCT00367133|3213483|Superiority or Other|||||||0.02|||||||ANCOVA|Repeated Measures Model. Adjusted for baseline visual acuity and prior photocoagulation; Accounted for correlated data from subjects with 2 study eyes||P values for two group comparisons for difference in mean change.|
1748766|NCT00367055|3213493|Superiority or Other|||||||0.99||||||p value is for Incremental AUC(0-10 min)|Van Elteren||||
1748767|NCT00367055|3213493|Superiority or Other|||||||0.376||||||p value is for Total AUC(0-10 min)|Van Elteren||||
1748768|NCT00366899|3213498|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.65||||||95.0|0.51|0.83||||||For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated|
1748769|NCT00366899|3213498|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.68|1.07||||||For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated|
1748770|NCT00366899|3213498|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.69||||||95.0|0.55|0.86||||||For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated|
1748771|NCT00366899|3213498|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.88||||||95.0|0.68|1.13||||||For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated|
1748772|NCT00366899|3213498|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.95||||||95.0|0.74|1.22||||||For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated|
1748773|NCT00366899|3213498|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.87||||||95.0|0.7|1.08||||||For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated|
1748774|NCT00366899|3213499|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.25||||||95.0|0.88|1.79||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated|
1748775|NCT00366899|3213499|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.75||||||95.0|0.63|0.89||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated|
1748776|NCT00366899|3213499|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.67|1.08||||||For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated|
1748777|NCT00366899|3213499|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.78||||||95.0|0.65|0.94||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated|
1748778|NCT00366899|3213500|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.81|1.3||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated|
1748779|NCT00366899|3213500|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.75|1.3||||||or Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated|
1748780|NCT00366899|3213501|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.72||||||95.0|0.54|0.96||||||For Hepatitis b the GMC ratio (13vPnC/7vPnC) was calculated|
1748781|NCT00366899|3213501|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the geometric mean concentration (GMC)/geometric mean titer (GMT) ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.96||||||95.0|0.72|1.27||||||For Hepatitis b the geometric mean concentration (GMC) ratio (13vPnC/7vPnC) was calculated|
1748782|NCT00366899|3213504|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.82|1.07||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated|
1748783|NCT00366899|3213504|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.83|1.07||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated|
1748784|NCT00366899|3213504|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.89|1.15||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated|
1748785|NCT00366899|3213504|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.87|1.17||||||For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated|
1749085|NCT00363311|3213928|Superiority or Other|||||||0.65|||||||Fisher Exact||||
1748786|NCT00366899|3213504|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.03||||||95.0|0.92|1.16||||||For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated|
1748787|NCT00366899|3213504|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.87|1.1||||||For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated|
1748788|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.|
1748789|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.|
1748790|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-2.4|2.1||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.|
1748791|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|3.8||||||95.0|-1.7|10.9||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.|
1748792|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-2.3|2.0||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated|
1748793|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-2.3|2.0||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.|
1748794|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|4.0||||||95.0|-0.4|8.7||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.|
1748795|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|1.4||||||95.0|-0.8|4.2||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated|
1748796|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|-0.4||||||95.0|-3.0|2.0||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.|
1748797|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|-0.5||||||95.0|-4.7|3.7||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥106 EU/mL threshold was calculated.|
1748798|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.|
1748799|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|-0.1||||||95.0|-4.3|4.1||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥162 EU/mL threshold was calculated|
1748800|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated|
1748801|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated|
1748802|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|-2.7||||||95.0|-7.3|1.8||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥21 EU/mL threshold was calculated.|
1748803|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-1.6|1.7||||||For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated|
1748804|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.7||||||95.0|-1.6|2.9||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC – 7vPnC) at ≥1:8 threshold was calculated.|
1748825|NCT00366678|3213513|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.98||||||95.0|0.72|1.34||||||For Polio Type 2 the GMC ratio was calculated|
1748805|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|-1.0||||||95.0|-5.0|2.8||||||For Polio Type 2 the difference in percentage between the two groups ( 13vPnC – 7vPnC) at ≥1:8 threshold was calculated.|
1748806|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|-0.1||||||95.0|-2.3|1.7||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC – 7vPnC) at ≥1:8 threshold was calculated.|
1748807|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|1.7||||||95.0|-3.9|7.1||||||For Tetanus the difference in percentage between the two groups ( 13vPnC – 7vPnC) at 0.1 IU/mL threshold was calculated.|
1748808|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|-3.5||||||95.0|-8.3|0.8||||||For Diptheria the difference in percentage between the two groups ( 13vPnC – 7vPnC) at 0.1 IU/mL threshold was calculated.|
1748809|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-1.8|1.6||||||For Diptheria the difference in percentages between the two groups ( 13vPnC – 7vPnC) at 0.01 IU/mL threshold was calculated.|
1748810|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.7||||||95.0|-8.2|9.5||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC – 7vPnC) at 1.0 μg/mL threshold was calculated.|
1748811|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|-3.2||||||95.0|-9.1|2.4||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC – 7vPnC) at 0.15 μg/mL threshold was calculated.|
1748812|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.7||||||95.0|-3.6|5.0||||||For hepatitis B the difference in percentages between the two groups (13vPnC – 7vPnC) at ≥10.0 mIU/mL threshold was calculated.|
1748813|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|-3.2||||||95.0|-7.8|1.0||||||For Pertactin the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥40 EU/mL threshold was calculated.|
1748814|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-1.5|1.4||||||For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.|
1748815|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|-0.9||||||95.0|-5.0|2.9||||||For Pertussis FHA the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥31 EU/mL threshold was calculated.|
1748816|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-1.6|1.4||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC – 7vPnC) at ≥7.82 EU/mL threshold was calculated.|
1748817|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-1.6|1.4||||||For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated|
1748818|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|0.0||||||95.0|-4.0|3.8||||||For Pertussis PT the difference in percentages between the two groups (13vPnC – 7vPnC) at ≥16 EU/mL threshold was calculated.|
1748819|NCT00366899|3213505|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.|Difference|-0.4||||||95.0|-2.2|1.0||||||For Pertussis PT the difference in percentages between the two groups (13vPnC – 7vPnC) at ≥5 EU/mL threshold was calculated.|
1748820|NCT00366678|3213512|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.99||||||95.0|0.86|1.14||||||For Pertussis - PT the GMC ratio was calculated|
1748821|NCT00366678|3213512|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.85||||||95.0|0.72|1.0||||||For Pertussis - FHA the GMC ratio was calculated|
1748822|NCT00366678|3213512|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.92||||||95.0|0.84|1.02||||||For Pertussis - PT the GMC ratio was calculated|
1748823|NCT00366678|3213512|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.87||||||95.0|0.78|0.98||||||For Pertussis - FHA the GMC ratio was calculated|
1748824|NCT00366678|3213513|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.84||||||95.0|0.6|1.17||||||For Polio Type 3 the GMC ratio was calculated|
1749527|NCT00360334|3214295|Superiority or Other|||||||0.125|||||||ANCOVA||||
1748826|NCT00366678|3213513|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.01||||||95.0|0.72|1.41||||||For Polio Type 1 the GMC ratio was calculated|
1748827|NCT00366678|3213513|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.78||||||95.0|0.59|1.02||||||For Polio Type 3 the GMC ratio was calculated|
1748828|NCT00366678|3213513|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.82||||||95.0|0.66|1.03||||||For Polio Type 2 the GMC ratio was calculated|
1748829|NCT00366678|3213513|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.88||||||95.0|0.71|1.09||||||For Polio Type 1 the GMC ratio was calculated|
1748830|NCT00366678|3213514|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.04||||||95.0|0.82|1.32||||||For Hib (PRP) the GMC ratio was calculated|
1748831|NCT00366678|3213514|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.91||||||95.0|0.73|1.14||||||For Hib (PRP) the GMC ratio was calculated|
1748832|NCT00366678|3213515|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.86||||||95.0|0.69|1.08||||||For Tetanus the GMC ratio was calculated|
1748833|NCT00366678|3213515|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.8||||||95.0|0.67|0.97||||||For Diphtheria the GMC ratio was calculated|
1748834|NCT00366678|3213515|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.94||||||95.0|0.82|1.08||||||For Tetanus the GMC ratio was calculated|
1748835|NCT00366678|3213515|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.77||||||95.0|0.66|0.9||||||For Diphtheria the GMC ratio was calculated|
1748836|NCT00366678|3213518|Superiority or Other||Ratio|0.96||||||95.0|0.78|1.19||||||For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated|
1748837|NCT00366678|3213518|Superiority or Other||Ratio|0.85||||||95.0|0.67|1.07||||||For serotype 23F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748838|NCT00366678|3213518|Superiority or Other||Ratio|0.81||||||95.0|0.67|1.0||||||For serotype 23F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748839|NCT00366678|3213518|Superiority or Other||Ratio|1.39||||||95.0|1.08|1.79||||||For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated|
1748840|NCT00366678|3213518|Superiority or Other||Ratio|0.91||||||95.0|0.68|1.2||||||For serotype 19F after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748841|NCT00366678|3213518|Superiority or Other||Ratio|1.26||||||95.0|1.0|1.59||||||For serotype 19F after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748842|NCT00366678|3213518|Superiority or Other||Ratio|0.95||||||95.0|0.78|1.15||||||For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated|
1748843|NCT00366678|3213518|Superiority or Other||Ratio|0.86||||||95.0|0.69|1.08||||||For serotype 18C after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748844|NCT00366678|3213518|Superiority or Other||Ratio|0.82||||||95.0|0.69|0.97||||||For serotype 18C after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748845|NCT00366678|3213518|Superiority or Other||Ratio|1.22||||||95.0|1.0|1.49||||||For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated|
1748846|NCT00366678|3213518|Superiority or Other||Ratio|0.72||||||95.0|0.58|0.9||||||For serotype 14 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748847|NCT00366678|3213518|Superiority or Other||Ratio|0.88||||||95.0|0.73|1.06||||||For serotype 14 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748848|NCT00366678|3213518|Superiority or Other||Ratio|1.13||||||95.0|0.95|1.33||||||For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated|
1748849|NCT00366678|3213518|Superiority or Other||Ratio|0.71||||||95.0|0.59|0.85||||||For serotype 9V after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748850|NCT00366678|3213518|Superiority or Other||Ratio|0.8||||||95.0|0.68|0.94||||||For serotype 9V after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748851|NCT00366678|3213518|Superiority or Other||Ratio|0.87||||||95.0|0.69|1.1||||||For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated|
1748852|NCT00366678|3213518|Superiority or Other||Ratio|1.07||||||95.0|0.82|1.4||||||For serotype 6B after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748853|NCT00366678|3213518|Superiority or Other||Ratio|0.93||||||95.0|0.77|1.13||||||For serotype 6B after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748854|NCT00366678|3213518|Superiority or Other||Ratio|1.04||||||95.0|0.86|1.26||||||For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose) was calculated|
1748855|NCT00366678|3213518|Superiority or Other||Ratio|0.83||||||95.0|0.67|1.03||||||For serotype 4 after the toddler dose the GMC ratio (7vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748856|NCT00366678|3213518|Superiority or Other||Ratio|0.87||||||95.0|0.73|1.03||||||For serotype 4 after the toddler dose the GMC ratio (13vPnC Infant Series/13vPnC Toddler Dose After Toddler Dose / 7vPnC Infant Series/7vPnC Toddler Dose After Toddler Dose) was calculated|
1748857|NCT00366678|3213519|Superiority or Other||Difference|-0.1||||||95.0|-4.1|3.7||||||For serotype 23F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748858|NCT00366678|3213519|Superiority or Other||Difference|0.5||||||95.0|-1.9|4.4||||||For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated|
1748859|NCT00366678|3213519|Superiority or Other||Difference|0.4||||||95.0|-1.8|3.9||||||For serotype 23F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748860|NCT00366678|3213519|Superiority or Other||Difference|-0.3||||||95.0|-5.5|4.4||||||For serotype 19F the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748861|NCT00366678|3213519|Superiority or Other||Difference|0.5||||||95.0|-2.9|5.4||||||For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated|
1748862|NCT00366678|3213519|Superiority or Other||Difference|0.2||||||95.0|-3.1|4.7||||||For serotype 19F the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748863|NCT00366678|3213519|Superiority or Other||Difference|-1.0||||||95.0|-5.5|2.8||||||For serotype 18C the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748864|NCT00366678|3213519|Superiority or Other||Difference|1.3||||||95.0|-1.1|5.7||||||For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated|
1748865|NCT00366678|3213519|Superiority or Other||Difference|0.4||||||95.0|-1.8|3.8||||||For serotype 18C the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748866|NCT00366678|3213519|Superiority or Other||Difference|-0.9||||||95.0|-4.9|2.1||||||For serotype 14 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748867|NCT00366678|3213519|Superiority or Other||Difference|0.5||||||95.0|-1.8|4.4||||||For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated|
1748868|NCT00366678|3213519|Superiority or Other||Difference|-0.4||||||95.0|-2.5|2.4||||||For serotype 14 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748869|NCT00366678|3213519|Superiority or Other||Difference|0.0||||||95.0|-3.3|3.0||||||For serotype 9V the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748870|NCT00366678|3213519|Superiority or Other||Difference|0.0||||||95.0|-1.8|3.3||||||For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated|
1748871|NCT00366678|3213519|Superiority or Other||Difference|0.0||||||95.0|-1.7|2.9||||||For serotype 9V the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748872|NCT00366678|3213519|Superiority or Other||Difference|-1.1||||||95.0|-5.8|2.7||||||For serotype 6B the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748873|NCT00366678|3213519|Superiority or Other||Difference|1.4||||||95.0|-1.1|5.9||||||For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated|
1748874|NCT00366678|3213519|Superiority or Other||Difference|0.4||||||95.0|-1.8|3.8||||||For serotype 6B the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748875|NCT00366678|3213519|Superiority or Other||Difference|-0.9||||||95.0|-4.9|2.1||||||For serotype 4 the difference in percentages between the two groups (7vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748876|NCT00366678|3213519|Superiority or Other||Difference|0.9||||||95.0|-0.9|4.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 13vPnC Toddler Dose) was calculated|
1749086|NCT00363311|3213929|Superiority or Other||Relative Risk Estimate|0.7||||0.079||95.0|0.46|1.05||Statistical data are for Overall (Years 0-3)|Log Rank||||
1748877|NCT00366678|3213519|Superiority or Other||Difference|0.0||||||95.0|-1.7|2.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC Infant Series / 13vPnC Toddler Dose - 7vPnC Infant Series / 7vPnC Toddler Dose) was calculated|
1748878|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.2||||||95.0|-3.1|4.5||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated|
1748879|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.7|2.8||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated|
1748880|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-4.5||||||95.0|-13.2|4.4||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 (μg/mL) threshold was calculated|
1748881|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.9||||||95.0|-3.2|5.0||||||For Hib (PRP) the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 (μg/mL) threshold was calculated|
1748882|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-0.8||||||95.0|-3.1|1.9||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated|
1748883|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-0.5||||||95.0|-3.1|3.0||||||For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated|
1748884|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-0.5||||||95.0|-3.6|3.5||||||For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated|
1748885|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-0.3||||||95.0|-5.0|4.3||||||For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated|
1748886|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-4.3||||||95.0|-11.4|2.6||||||For Polio Type 2 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated|
1748887|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-2.3||||||95.0|-7.6|3.0||||||For Polio Type 1 the difference in percentages between the two groups (13vPnC - 7vPnC) at (1:8) threshold was calculated|
1748888|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated|
1748889|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-2.3||||||95.0|-5.8|1.8||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated|
1748890|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated|
1748891|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-0.8||||||95.0|-3.1|1.8||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated|
1748892|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.5|1.5||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated|
1748893|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|2.7||||||95.0|-3.7|9.2||||||For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated|
1748894|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 (IU/mL) threshold was calculated|
1748895|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-8.0||||||95.0|-14.9|-1.2||||||For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 (IU/mL) threshold was calculated|
1748915|NCT00366548|3213524|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Difference|0.84||||||95.0|0.72|0.97||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated|
1748896|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-3.0||||||95.0|-8.0|2.5||||||For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (75.00 EU/mL) threshold was calculated|
1748897|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (7.82 EU/mL) threshold was calculated|
1748898|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated|
1748899|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|2.1||||||95.0|-1.4|6.8||||||For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (17.00 EU/mL) threshold was calculated|
1748900|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.7|2.7||||||For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (5 EU/mL) threshold was calculated|
1748901|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥7.82 EU/mL) threshold was calculated|
1748902|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-2.3||||||95.0|-6.4|1.7||||||For Pertussis - FHAf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥36.00 EU/mL) threshold was calculated|
1748903|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated|
1748904|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-0.7||||||95.0|-4.8|3.3||||||For Pertussis - PTf the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥26.00 EU/mL) threshold was calculated|
1748905|NCT00366678|3213520|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For Pertussis - PT the difference in percentages between the two groups (13vPnC - 7vPnC) at (≥5 EU/mL) threshold was calculated|
1748906|NCT00366626|3213521|Superiority or Other||Mean Difference (Final Values)|1.46|Standard Deviation|6.1||0.28|2-Sided|95.0|-1.22|4.11|||ANOVA|||This was a 2 gene (asn40asn vs 40asp) by 2 medication (naltrexone vs. placebo)interaction analysis. The main hypothesis was that subjects who had 40asp OPRM1 allele would a greater naltrexone effect on drinking (Placebo – Naltrexxone) than the asn40asn subjects. Thus the null hypothesis was the gene by medication interaction.|
1748907|NCT00366626|3213522|Superiority or Other||Mean Difference (Final Values)|0.92|Standard Deviation|6.32||0.51|2-Sided|95.0|-1.85|3.69|||ANOVA|||This was a 2 gene (asn40asn vs 40asp) by two medication (naltrexone vs placebo) design. The main hypothesis was that the effect of naltrexone (mean naltrexone drinking – placebo drinking) would be greater in the 40asp subjects than in the asn40asn subjects. Thus the null hypothesis there would be no gene by medication interaction. The mean difference above is then the difference in the size of the naltrexone effect in the two genotypes, equivalent to the interaction.|
1748908|NCT00366548|3213524|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Difference|0.91||||||95.0|0.8|1.04||||||For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated|
1748909|NCT00366548|3213524|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Difference|1.05||||||95.0|0.93|1.18||||||For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated|
1748910|NCT00366548|3213524|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.81|1.13||||||For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated|
1748911|NCT00366548|3213524|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Difference|0.97||||||95.0|0.83|1.13||||||For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated|
1748912|NCT00366548|3213524|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Difference|0.93||||||95.0|0.83|1.04||||||For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated|
1748913|NCT00366548|3213524|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Difference|0.94||||||95.0|0.81|1.1||||||For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated|
1748914|NCT00366548|3213524|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Difference|0.84||||||95.0|0.71|0.98||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated|
1749010|NCT00365105|3213725|Superiority|||||||0.46||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Functional Well-Being|
1748916|NCT00366548|3213524|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Difference|0.98||||||95.0|0.86|1.13||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated|
1748917|NCT00366548|3213524|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.79|1.15||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated|
1748918|NCT00366548|3213524|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Difference|0.97||||||95.0|0.85|1.1||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated|
1748919|NCT00366548|3213524|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Difference|0.9||||||95.0|0.72|1.14||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated|
1748920|NCT00366548|3213524|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Difference|0.96||||||95.0|0.81|1.13||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated|
1748921|NCT00366548|3213527|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.0||||||95.0|-1.7|1.6||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748922|NCT00366548|3213527|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.0||||||95.0|-1.7|1.6||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748923|NCT00366548|3213527|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-0.4||||||95.0|-2.4|1.2||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748924|NCT00366548|3213527|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-0.4||||||95.0|-2.4|1.1||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748925|NCT00366548|3213527|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.6||||||95.0|-3.7|4.9||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748926|NCT00366548|3213527|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.8||||||95.0|-0.8|3.0||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748927|NCT00366548|3213527|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-0.9||||||95.0|-3.4|1.1||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748928|NCT00366548|3213527|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.4||||||95.0|-2.0|2.9||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748929|NCT00366548|3213527|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.4||||||95.0|-1.2|2.3||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748930|NCT00366548|3213527|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.0||||||95.0|-2.1|1.9||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748931|NCT00366548|3213527|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-0.4||||||95.0|-2.4|1.1||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748932|NCT00366548|3213527|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.4||||||95.0|-1.7|2.6||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.|
1748933|NCT00366548|3213527|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.0||||||95.0|-2.1|1.9||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated.|
1748934|NCT00366548|3213528|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-1.3||||||95.0|-3.6|0.3||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748935|NCT00366548|3213528|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-0.8||||||95.0|-3.2|1.2||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748936|NCT00366548|3213528|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.4||||||95.0|-5.8|6.7||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1749011|NCT00365105|3213725|Superiority|||||||0.7||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Emotional Well-Being|
1749528|NCT00360334|3214296|Superiority or Other|||||||0.1|||||||Mixed Model Repeated Measures||||
1748937|NCT00366548|3213528|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|1.7||||||95.0|-3.0|6.4||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748938|NCT00366548|3213528|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-1.3||||||95.0|-4.1|1.1||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748939|NCT00366548|3213528|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|3.4||||||95.0|-0.9|7.9||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748940|NCT00366548|3213528|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-6.3||||||95.0|-12.1|-0.7||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748941|NCT00366548|3213528|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-2.5||||||95.0|-6.1|0.6||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748942|NCT00366548|3213528|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.0||||||95.0|-3.0|3.0||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748943|NCT00366548|3213528|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-2.9||||||95.0|-6.9|0.7||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748944|NCT00366548|3213528|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-0.4||||||95.0|-3.7|2.8||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748945|NCT00366548|3213528|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-5.5||||||95.0|-14.2|3.3||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748946|NCT00366548|3213528|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-0.8||||||95.0|-5.4|3.7||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748947|NCT00366340|3213549|Non-Inferiority or Equivalence|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.93|||||2-Sided|95.0|0.71|1.22||||||For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated|
1748948|NCT00366340|3213549|Non-Inferiority or Equivalence|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.88|||||2-Sided|95.0|0.69|1.11||||||For hepatitis B the GMC ratio (13vPnC/7vPnC) was calculated.|
1748949|NCT00366340|3213550|Non-Inferiority or Equivalence|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.87|||||2-Sided|95.0|0.75|1.01||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated|
1748950|NCT00366340|3213550|Non-Inferiority or Equivalence|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|0.68|||||2-Sided|95.0|0.57|0.8||||||For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated|
1748951|NCT00366340|3213551|Non-Inferiority or Equivalence|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.15|||||2-Sided|95.0|0.95|1.39||||||For Haemophilus influenzae type b µg/mL the GMC ratio (13vPnC/7vPnC) was calculated|
1748952|NCT00366340|3213551|Non-Inferiority or Equivalence|Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).|Ratio|1.23|||||2-Sided|95.0|0.96|1.58||||||For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated|
1748953|NCT00366340|3213552|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.8||||||95.0|-1.3|3.3||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated|
1748954|NCT00366340|3213552|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated|
1748955|NCT00366340|3213552|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.4|1.4||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated|
1748956|NCT00366340|3213552|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|1.7|||||2-Sided|95.0|-0.4|4.4||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated|
1749012|NCT00365105|3213725|Superiority|||||||0.57||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Social/Family Well-Being|
1749529|NCT00360334|3214297|Superiority or Other|||||||0.014|||||||Mixed Model Repeated Measures||||
1748957|NCT00366340|3213552|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-1.3||||||95.0|-5.0|2.3||||||For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 10.0 mIU/mL threshold was calculated|
1748958|NCT00366340|3213552|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0|||||2-Sided|95.0|-1.5|1.5||||||For Haemophilus Influenzae Type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated|
1748959|NCT00366340|3213552|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|-4.5||||||95.0|-9.3|0.3||||||For diphtheria toxoid the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated|
1748960|NCT00366340|3213552|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|0.0||||||95.0|-1.4|1.5||||||For diphtheria toxoid the difference in percentages between the two groups(13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated|
1748961|NCT00366340|3213552|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|4.5|||||2-Sided|95.0|-4.1|13.0||||||For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated|
1748962|NCT00366340|3213552|Non-Inferiority or Equivalence|Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.|Difference|2.6|||||2-Sided|95.0|-3.0|8.3||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated|
1748963|NCT00366340|3213555|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|0.88|||||2-Sided|95.0|0.73|1.06||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated|
1748964|NCT00366340|3213555|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|0.6|||||2-Sided|95.0|0.51|0.71||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated|
1748965|NCT00366340|3213555|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|2.25|||||2-Sided|95.0|2.04|2.49||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated|
1748966|NCT00366340|3213555|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|0.9|||||2-Sided|95.0|0.76|1.07||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated|
1748967|NCT00366340|3213555|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|0.84|||||2-Sided|95.0|0.74|0.96||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated|
1748968|NCT00366340|3213555|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|0.65|||||2-Sided|95.0|0.52|0.82||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated|
1748969|NCT00366340|3213555|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lower limit of the 2-sided 95% CI for the GMC ratio (13vPnC/7vPnC) > 0.5 (2-fold criterion).|Ratio|0.73|||||2-Sided|95.0|0.63|0.84||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated|
1748970|NCT00366340|3213556|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-0.8|||||2-Sided|95.0|-6.0|4.5||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748971|NCT00366340|3213556|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-0.3|||||2-Sided|95.0|-3.8|3.3||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748972|NCT00366340|3213556|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-1.4|||||2-Sided|95.0|-4.2|1.2||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748973|NCT00366340|3213556|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|1.5|||||2-Sided|95.0|-0.9|4.1||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748974|NCT00366340|3213556|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|2.2|||||2-Sided|95.0|-0.4|5.2||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748975|NCT00366340|3213556|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|-9.6|||||2-Sided|95.0|-16.0|-3.3||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1748976|NCT00366340|3213556|Non-Inferiority or Equivalence|Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%.|Difference|0.0|||||2-Sided|95.0|-2.5|2.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1749013|NCT00365105|3213725|Superiority|||||||0.97||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||Physical Well-Being|
1749014|NCT00365105|3213725|Superiority|||||||0.96||||||Two-sided significance level of 0.01|Wilcoxon (Mann-Whitney)|||FACT-G Total|
1748977|NCT00366301|3213557|Superiority or Other||Percent Change in Log CRP|20.0|Standard Error of the Mean|10.0|<|0.05|2-Sided|95.0|||||Mixed Models Analysis|Adjusted models included terms for baseline HbA1c and weight and change in weight at each time point.||As hsCRP was measured at both 6 and 14 weeks, linear mixed models conditioning on baseline hsCRP and adjusting for treatment stratum were constructed with the dependent variable being change in lnCRP. The means at each time point were estimated from a repeated-measures model incorporating all 3 time points. The interventions were assessed by fitting terms corresponding to study drug and treatment arm assignment.|
1748978|NCT00366249|3213559|Non-Inferiority or Equivalence|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railkar|-6.3||||||95.0|-13.6|1.0|||||Adjusted for PEDIS score||
1748979|NCT00366249|3213561|Non-Inferiority or Equivalence|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railkar|-6.7||||||95.0|-12.3|-1.1|||||Adjusted for PEDIS score|Analysis provided for Cure|
1748980|NCT00366249|3213563|Non-Inferiority or Equivalence|Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.|Mehrotra and Railker|-5.5||||||95.0|-11.0|0.1|||||Adjusted for Perfusion, Extent, Depth/tissue loss, Infection, and Sensation (PEDIS) score|Analysis provided for Cure|
1748981|NCT00365794|3213617|Other|||||||0.83|||||||t-test, 2 sided||||
1748982|NCT00365794|3213618|Other|||||||0.97|||||||t-test, 2 sided||||
1748983|NCT00365794|3213619|Other|||||||0.06|||||||t-test, 2 sided||||
1748984|NCT00365794|3213620|Other|Test for HDL cholesterol||||||0.004|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel|
1748985|NCT00365794|3213620|Other|Test for LDL cholesterol||||||0.02|||||||t-test, 2 sided|||nts A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel|
1748986|NCT00365794|3213620|Other|Test for total cholesterol||||||0.004|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel|
1748987|NCT00365794|3213620|Other|Test for fasting triglycerides||||||0.02|||||||t-test, 2 sided|||A change in 20 plasma lipids (fasting triglycerides and lipid fractions) after 20 weeks of treatment with testosterone gel.|
1748988|NCT00365794|3213621|Other|||||||0.0006|||||||t-test, 2 sided|||Change in DEXA extremity (appendicular) lean tissue, a measure of extremity muscle mass after 20 weeks ot treatent with testosterone gel.|
1748989|NCT00365794|3213622|Other|||||||0.03|||||||t-test, 2 sided|||Statistical analysis for change in rate of peripheral glucose disposal (test of peripheral insulin sensitivity) after treatment with testosterone gel for 20 weeks|
1748990|NCT00365794|3213622|Other|||||||0.59|||||||t-test, 2 sided|||Statistical analysis for change in hepatic glucose output (measure of central insulin sensitivity) after treatment with testosterone gel for 20 weeks|
1748991|NCT00365794|3213622|Other|||||||0.04|||||||t-test, 2 sided|||Statistical analysis for change in whole body insulin sensitivity after treatment with testosterone gel for 20 weeks.|
1748992|NCT00365794|3213623|Other|||||||0.0002||||||No adjustment for multiple comparisons.|t-test, 2 sided||||
1748993|NCT00365794|3213624|Other|||||||0.008|||||||t-test, 2 sided||||
1748994|NCT00365794|3213625|Other|||||||0.12||||||No adjustment in p for multiple comparisons.|t-test, 2 sided||||
1748995|NCT00365794|3213626|Other|||||||0.01|||||||t-test, 2 sided|||Statistical analysis is for change in extremity fat mass after 20 weeks of testosterone gel.|
1748996|NCT00365794|3213626|Other|||||||0.0007|||||||t-test, 2 sided|||Statistical analysis is for change in trunk fat mass after 20 weeks of testosterone gel.|
1748997|NCT00365794|3213626|Other|||||||0.003|||||||t-test, 2 sided|||Total fat mass|
1748998|NCT00365794|3213626|Other|||||||0.77|||||||t-test, 2 sided|||Total body mass|
1748999|NCT00365716|3213629|Superiority or Other||Vaccine Efficacy|89.5||||||95.0|70.7|97.3|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."||
1749000|NCT00365508|3213640|Superiority or Other|||||||0.05||||||a priori threshold for statistical significance|Chi-squared|||Chi-square was used to examine the relationship between treatment arm and 24-hour point prevalence abstinence at 6-months.|
1749001|NCT00365456|3213641|Superiority or Other||Mean Difference (Final Values)|1.012|Standard Error of the Mean|1.0045||0.01|2-Sided|95.0|1.003|1.021||No multiplicity correction of the significance level was performed as only one primary endpoint was planned.|ANCOVA|Estimation allowing for unequal variance in the two treatment groups and robust estimates for the standard errors were obtained.||An analysis of covariance (ANCOVA) model was used including treatment group, stratum and pooled centre as fixed effects and log (BMD at Baseline III (month 24)) as a covariate (log-normally distributed data assumed). Least square mean change from baseline III (month 24), 95% confidence interval and p-value for the treatment effect (PTH (1-84) vs. Risedronate) was calculated. Superiority was claimed if lower limit of the interval was above 1. Results were back-transformed from the log scale.|
1749002|NCT00365378|3213656|Superiority or Other||Vaccine Efficacy|100.0||||||95.0|84.0|100.0|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."||
1749003|NCT00365378|3213657|Superiority or Other||Vaccine Efficacy|94.3||||||95.0|87.8|97.7|||||"Vaccine Efficacy (% relative risk reduction)~Confidence Interval based on binomial tail probabilities and not from a dispersion parameter."||
1749004|NCT00365352|3213686|Superiority or Other||Odds Ratio (OR)|4.287||||0.0001||95.0|2.338|7.861|||Regression, Logistic|A logistic regression model was used with treatment and pooled center as explanatory factors.|||
1749005|NCT00365352|3213687|Superiority or Other||Mean Difference (Final Values)|-3.5||||0.0015||95.0|-5.6|-1.3|||ANCOVA||Mean difference was adjusted for Baseline value, treatment pooled sites, and treatment by pool site interaction.||
1749006|NCT00365300|3213688|Superiority or Other||Risk Difference (RD)|0.004||||1|||||||Fisher Exact||||
1749007|NCT00365105|3213723|Superiority|||||||0.15||||||Significance level of 0.05|t-test, 2 sided|||VAS Score|
1749008|NCT00365105|3213723|Superiority|||||||0.43||||||Significance level of 0.05|t-test, 2 sided|||Index Score|
1749009|NCT00365105|3213724|Superiority|||||||0.99||||||2-sided significance level of 0.05|Wilcoxon (Mann-Whitney)||||
1749015|NCT00365105|3213726|Superiority||Hazard Ratio (HR)|1.14||||0.37|2-Sided|95.0|0.86|1.52|||Log Rank|||Assuming the disease site distribution is 40%, 40%, and 20% from prostate, breast, and lung cancer populations, respectively, the weighted yearly death rate for patients treated with bisphosphonates only is 0.4390, translating to a median overall survival time of 18.9 months assuming an exponential distribution. Statistical power to detect a relative difference of 33% in the yearly death rate is 70% using a two-sided log-rank test at a 0.05 significance level and 87% to detect 50% difference.|
1749016|NCT00365105|3213727|Superiority|The power of detecting an improvement from 55% in the control arm to 41% in the experimental arm with a two-sided Fisher‘s exact test at alpha 0.05 is 66%.||||||0.26|||||||Fisher Exact||||
1749017|NCT00365105|3213728|Superiority or Other||Hazard Ratio (HR)|1.04||||0.844|2-Sided|95.0|0.7|1.54|||Log Rank|||Assuming an exponential distribution, the weighted yearly SRE hazard rate for patients treated with bisphosphonates only is 0.7991 which translates to a median time to SRE of 10.4 months. The study was designed to show a 33% relative reduction in the yearly SRE hazard rate, i.e. 15.6 months median time to SRE. Using a two-sided log-rank test assuming a type I error of 0.05, one planned interim analysis with 90% statistical power, 257 SREs are required with a total of 316 patients.|
1749018|NCT00364949|3213737|Superiority or Other|||||||0.325|||||||t-test, 2 sided||||
1749019|NCT00364949|3213738|Superiority or Other|||||||0.77|||||||t-test, 2 sided||||
1749020|NCT00364949|3213739|Superiority or Other|||||||0.156|||||||t-test, 2 sided||||
1749021|NCT00364949|3213740|Superiority or Other|||||||0.042|||||||t-test, 2 sided||||
1749022|NCT00364949|3213741|Superiority or Other|||||||0.049|||||||t-test, 2 sided||||
1749023|NCT00364858|3213749|Superiority or Other||Agresti and Min|-0.176||||||95.0|-0.357|0.058||||||Difference in proportion of Clinical Success = (Proportion of participants with Clinical Success Q4 - Proportion of participants with Clinical Success Q2).|
1749024|NCT00364845|3213752|Superiority or Other||Proportion achieving target|0.95||||||95.0|0.751|0.999|||||||
1749025|NCT00364845|3213752|Superiority or Other||Proportion achieving target|0.389||||||95.0|0.173|0.643|||||||
1749026|NCT00364832|3213759|Superiority or Other||Estimated Conversion Factor 90% CI|0.93|||||2-Sided|90.0|0.81|1.09|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ 4 weeks (0.4, 0.8 and 1.2 dose group)|
1749027|NCT00364832|3213759|Superiority or Other||Estimated Conversion Factor 90% CI|0.72|||||2-Sided|90.0|0.55|0.86|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ 3 weeks (0.4, 0.8 and 1.2 dose group)|
1749028|NCT00364832|3213759|Superiority or Other||Estimated Conversion Factor 90% CI|0.81|||||2-Sided|90.0|0.73|0.9|||||To analyze dose conversion factors (CF), 2nd regression (R) analysis was performed on 3 different CF dose groups, using the R slope estimates of Hb change over 6 weeks. Equi-effective CF was interpolated using value that gives an Hb change of zero.|All cohorts with dosing frequency 1x/ week (0.4, 0.8 and 1.2 dose group)|
1749029|NCT00364533|3213807|Superiority or Other||LS mean difference of SPID48|82.4|||<|0.001||95.0|38.96|125.88|||ANCOVA|||The study was terminated and did not reach the planned sample size.|
1749030|NCT00364533|3213807|Superiority or Other||LS mean difference of SPID48|81.5|||<|0.001||95.0|39.21|123.8|||ANCOVA|||The study was terminated and did not reach the planned sample size.|
1749031|NCT00364533|3213807|Superiority or Other||LS mean difference of SPID48|81.5|||<|0.001||95.0|38.66|124.29|||ANCOVA|||The study was terminated and did not reach the planned sample size.|
1749032|NCT00364533|3213807|Superiority or Other||LS mean difference of SPID48|91.4|||<|0.001||95.0|49.77|133.07|||ANCOVA|||The study was terminated and did not reach the planned sample size.|
1749033|NCT00364377|3213808|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||Paired comparisons (within groups) to examine differences between the baseline study and after 8-weeks of treatment were made using Student’s two-tailed t-test for paired samples. Between-group comparisons were made using Student’s two-tailed t-test for unpaired samples. Given the previously observed variation in fasting glucose|
1749034|NCT00364182|3213817|Superiority or Other||Mean Difference (Net)|3.6||||0.131|2-Sided|95.0|-1.1|8.4|||ANOVA||||
1749035|NCT00364182|3213817|Superiority or Other||Mean Difference (Net)|-1.6||||0.592|2-Sided|95.0|-7.5|4.3|||ANOVA||||
1749036|NCT00364182|3213817|Superiority or Other||Mean Difference (Net)|-2.1||||0.544|2-Sided|95.0|-9.2|4.9|||ANOVA||||
1749037|NCT00364182|3213821|Superiority or Other||Mean Difference (Net)|-0.3||||0.031|2-Sided|95.0|-0.5|0.0|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).|
1749038|NCT00364182|3213821|Superiority or Other||Mean Difference (Net)|-0.3||||0.002|2-Sided|95.0|-0.5|-0.1|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).|
1749039|NCT00364182|3213821|Superiority or Other||Mean Difference (Net)|-0.3||||0|2-Sided|95.0|-0.5|-0.2|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).|
1749040|NCT00364182|3213821|Superiority or Other||Mean Difference (Net)|-0.3||||0|2-Sided|95.0|-0.4|-0.1|||ANOVA|||Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).|
1749041|NCT00364182|3213822|Superiority or Other||Mean Difference (Net)|0.4||||0.093|2-Sided|95.0|-0.1|0.8|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).|
1749042|NCT00364182|3213822|Superiority or Other||Mean Difference (Net)|0.6||||0.004|2-Sided|95.0|0.2|0.9|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).|
1749043|NCT00364182|3213822|Superiority or Other||Mean Difference (Net)|0.4||||0.021|2-Sided|95.0|0.1|0.8|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).|
1749076|NCT00363415|3213900|Superiority or Other||||||<|0.001||||||P-value for Race: Caucasian.|Log Rank||||
1749044|NCT00364182|3213822|Superiority or Other||Mean Difference (Net)|0.4||||0.002|2-Sided|95.0|0.1|0.6|||ANOVA|||Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).|
1749045|NCT00364182|3213823|Superiority or Other||Mean Difference (Final Values)|2.0||||0.2167|2-Sided|95.0|-1.2|5.2||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA||||
1749046|NCT00364182|3213823|Superiority or Other||Mean Difference (Final Values)|-32.5|||<|0.0001|2-Sided|95.0|-38.5|-26.6||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA||||
1749047|NCT00364182|3213823|Superiority or Other||Mean Difference (Final Values)|-30.5|||<|0.0001|2-Sided|95.0|-36.5|-24.5||P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.|ANOVA||||
1749048|NCT00364130|3213825|Superiority or Other|||||||0.98||||||Outcome is not adjusted for multiple comparisons|Regression, Linear||||
1749049|NCT00364130|3213826|Superiority or Other|||||||0.7||||||The outcome is not adjusted for multiple comparisons|Regression, Linear||||
1749050|NCT00364130|3213827|Superiority or Other|||||||0.66||||||The outcome is not adjusted for multiple comparisons|Regression, Linear||||
1749051|NCT00364130|3213828|Superiority or Other|||||||0.84||||||The outcome is not adjusted for multiple comparisons|Regression, Linear||||
1749052|NCT00364130|3213829|Superiority or Other|||||||0.27||||||The outcome was not adjusted for multiple comparisons|Regression, Linear||||
1749053|NCT00364130|3213830|Superiority or Other|||||||0.02||||||The outcome is not adjusted for multiple comparisons|Regression, Linear||||
1749054|NCT00364130|3213831|Superiority or Other|||||||0.8||||||The outcome is not adjusted for multiple comparisons|Regression, Linear||||
1749055|NCT00364130|3213832|Superiority or Other|||||||0.38||||||The outcome is not adjusted for multiple comparisons|Regression, Linear||||
1749056|NCT00364013|3213836|Superiority or Other||Odds Ratio (OR)|0.98||||0.9822|2-Sided|95.0|0.65|1.47|||Stratified exact test|Adjusted for geographic region and ECOG score|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.||
1749057|NCT00364013|3213836|Superiority or Other||Odds Ratio (OR)|1.35||||0.0684|2-Sided|95.0|0.98|1.87|||Stratified exact test|Adjusted for geographic region and ECOG score.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFOX alone arm.||
1749058|NCT00364013|3213837|Superiority or Other||Normal score|1.83||||0.0678||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score <0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.|Overall survival comparisons in the mutant KRAS Efficacy Analysis Set was performed at an significance level of 4.99% conditional on a statistically significant difference for PFS in the Mutant KRAS Efficacy Analysis Set.|
1749059|NCT00364013|3213837|Superiority or Other||Normal score|-1.8||||0.0723||||||cP-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score <0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer overall survival time.|Overall survival comparisons in the wild-type KRAS Efficacy Analysis Set was performed at a significance level of 4.99% conditional on a statistically significant difference for PFS in the Wild-type KRAS Efficacy Analysis Set.|
1749060|NCT00364013|3213838|Superiority or Other||Normal score|2.28||||0.0227||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score <0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.|PFS in the Mutant KRAS Efficacy Analysis Set was compared at a significance level of 5% conditional on first demonstrating a significant treatment effect in PFS in the Wild-type KRAS Efficacy Analysis Set.|
1749061|NCT00364013|3213838|Superiority or Other||Normal score|-2.27||||0.0234||||||P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).|Stratified log-rank test||A normal score <0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.|PFS in the Wild-type KRAS Efficacy Analysis Set was compared at a significance level of 5%.|
1749062|NCT00363480|3213889|Superiority or Other||t-Distribution|50.2|||||2-Sided|95.0|43.15|57.32|||||||
1749063|NCT00363480|3213890|Superiority or Other||Percentage diffrence|-30.6|||<|0.0001|2-Sided|95.0|-37.89|-23.29|||McNemar|||Comparison between GOAL and ACT response|
1749064|NCT00363415|3213900|Superiority or Other||||||<|0.001||||||P-value for History of Brain Metastases: No.|Log Rank||||
1749065|NCT00363415|3213900|Superiority or Other||||||<|0.001||||||P-value for Number Metastatic Sites: >=3.|Log Rank||||
1749066|NCT00363415|3213900|Superiority or Other||||||<|0.092||||||P-value for Number Metastatic Sites: <=2.|Log Rank||||
1749067|NCT00363415|3213900|Superiority or Other||||||<|0.013||||||P-value for Age: >65 years.|Log Rank||||
1749068|NCT00363415|3213900|Superiority or Other||||||<|0.001||||||P-value for Age: <=65 years.|Log Rank||||
1749069|NCT00363415|3213900|Superiority or Other||||||<|0.005||||||P-value for LDH (lactate dehydrogenase): >Upper Limit of Normal.|Log Rank||||
1749070|NCT00363415|3213900|Superiority or Other||||||<|0.003||||||P-value for Region: Intercontinental Region.|Log Rank||||
1749071|NCT00363415|3213900|Superiority or Other||||||<|0.001||||||P-value for Region: European Union.|Log Rank||||
1749072|NCT00363415|3213900|Superiority or Other||||||<|0.084||||||P-value for Region: United States.|Log Rank||||
1749073|NCT00363415|3213900|Superiority or Other||||||<|0.519||||||P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 2.|Log Rank||||
1749074|NCT00363415|3213900|Superiority or Other||||||<|0.001||||||P-value for ECOG (Eastern Cooperative Oncology Group) Performance Status: 0 or 1.|Log Rank||||
1749075|NCT00363415|3213900|Superiority or Other||||||<|0.03||||||P-value for Race: Non-Caucasian.|Log Rank||||
1749087|NCT00363311|3213929|Superiority or Other||Relative Risk Estimate|0.59||||0.031||95.0|0.36|0.96||Statistical data are for Year 1.5|Log Rank||||
1749088|NCT00363311|3213930|Superiority or Other||Relative Risk Estimate|0.48||||0.053||95.0|0.22|1.03||Statistical data are for Overall (Years 0-3)|Log Rank||||
1749089|NCT00363311|3213930|Superiority or Other||Relative Risk Estimate|0.46||||0.13||95.0|0.16|1.31||Statistical data are for Year 1.5|Log Rank||||
1749090|NCT00363311|3213931|Superiority or Other||Relative Risk Estimate|0.61||||0.007||95.0|0.43|0.88||Statistical data are for Overall (Years 0-3)|Log Rank||||
1749091|NCT00363311|3213931|Superiority or Other||Relative Risk Estimate|0.56||||0.009||95.0|0.36|0.87||Statistical data are for Year 1.5|Log Rank||||
1749092|NCT00363246|3213934|Superiority or Other|||||||0.007|||||||t-test, 2 sided|||Energy level. No Wheelchair-related Falls vs. Wheelchair-related Falls.|
1749093|NCT00363246|3213934|Superiority or Other||||||<|0.001|||||||Chi-squared|||Pain when transfer. No Wheelchair-related Falls vs. Wheelchair-related Falls.|
1749094|NCT00363246|3213934|Superiority or Other||||||<|0.013|||||||Chi-squared|||Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Falls vs. Wheelchair-related Falls.|
1749095|NCT00363246|3213934|Superiority or Other||||||<|0.033|||||||Chi-squared|We used chi-squared test for categorical variable (most variables) and t-test (2-sided) for continuous variables (few variables).||Health Status. No Wheelchair-related Falls vs. Wheelchair-related Falls.|
1749096|NCT00363246|3213935|Superiority or Other|||||||0.009|||||||t-test, 2 sided|||Energy level. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.|
1749097|NCT00363246|3213935|Superiority or Other|||||||0.0001|||||||Chi-squared|||Pain when transfer. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.|
1749098|NCT00363246|3213935|Superiority or Other|||||||0.013|||||||Chi-squared|||Pain in last 4 weeks (interference with daily activities). No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.|
1749099|NCT00363246|3213935|Superiority or Other|||||||0.049|||||||Chi-squared|||Health Status. No Wheelchair-related Fall Injuries vs. Wheelchair-related Fall Injuries.|
1749100|NCT00363142|3213951|Non-Inferiority or Equivalence|Non-inferiority of FPV/r100 to FPV/r200 would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in percentage of participants not meeting the virologic failure definition [FPV/r100 minus FPV/r200] was -12% or greater.|Difference in the percentages|-2.12||||||95.0|-9.36|5.12|||||Difference in percentages = percentage in Arm 1 minus percentage in Arm 2||
1749101|NCT00363129|3213954|Superiority or Other|||||||1|||||||Fisher Exact||||
1749102|NCT00363129|3213955|Superiority or Other|||||||0.49|||||||Fisher Exact||||
1749103|NCT00363129|3213956|Superiority or Other|||||||0.43|||||||Chi-squared||||
1749104|NCT00362882|3213980|Superiority|||||||0.17|||||||Log Rank||||
1749105|NCT00362648|3213990|Superiority or Other||Percentage|5.3||||||95.0|2.2|10.6||||||Serotype P1A[8]|
1749106|NCT00362648|3213990|Superiority or Other||Percentage|0.0||||||95.0|0.0|2.8||||||Serotype G4|
1749107|NCT00362648|3213990|Superiority or Other||Percentage|3.0||||||95.0|0.8|7.6||||||Serotype G3|
1749108|NCT00362648|3213990|Superiority or Other||Percentage|0.8||||||95.0|0.0|4.1||||||Serotype G2|
1749109|NCT00362648|3213990|Superiority or Other||Percentage|2.3||||||95.0|0.5|6.5||||||Serotype G1|
1749110|NCT00362648|3213990|Superiority or Other||Percentage|18.2||||||95.0|12.0|25.8||||||Anti-rotavirus IgA|
1749111|NCT00362648|3213990|Superiority or Other||Percentage|27.5||||||95.0|20.0|36.0||||||Serotype P1A[8]|
1749112|NCT00362648|3213990|Superiority or Other||Percentage|18.3||||||95.0|12.1|26.0||||||Serotype G4|
1749113|NCT00362648|3213990|Superiority or Other||Percentage|28.2||||||95.0|20.7|36.8||||||Serotype G3|
1749114|NCT00362648|3213990|Superiority or Other||Percentage|9.9||||||95.0|5.4|16.4||||||Serotype G2|
1749115|NCT00362648|3213990|Superiority or Other||Percentage|32.1||||||95.0|24.2|40.8||||||Serotype G1|
1749116|NCT00362648|3213990|Superiority or Other||Percentage|87.8||||||95.0|80.9|92.9||||||Anti-rotavirus IgA|
1749117|NCT00362648|3213991|Superiority or Other||Percentage|4.7||||||95.0|2.1|9.1||||||Serotype P1A[8]|
1749118|NCT00362648|3213991|Superiority or Other||Percentage|2.4||||||95.0|0.6|5.9||||||Serotype G4|
1749119|NCT00362648|3213991|Superiority or Other||Percentage|2.4||||||95.0|0.6|5.9||||||Serotype G3|
1749120|NCT00362648|3213991|Superiority or Other||Percentage|3.0||||||95.0|1.0|6.8||||||Serotype G2|
1749121|NCT00362648|3213991|Superiority or Other||Percentage|0.0||||||95.0|0.0|2.2||||||Serotype G1|
1749122|NCT00362648|3213991|Superiority or Other||Percentage|20.1||||||95.0|14.4|27.0||||||Anti-rotavirus IgA|
1749123|NCT00362648|3213991|Superiority or Other||Percentage|14.4||||||95.0|9.7|20.2||||||Serotype P1A[8]|
1749124|NCT00362648|3213991|Superiority or Other||Percentage|26.5||||||95.0|20.3|33.3||||||Serotype G4|
1749125|NCT00362648|3213991|Superiority or Other||Percentage|6.3||||||95.0|3.3|10.8||||||Serotype G3|
1749126|NCT00362648|3213991|Superiority or Other||Percentage|9.0||||||95.0|5.3|14.0||||||Serotype G2|
1749127|NCT00362648|3213991|Superiority or Other||Percentage|18.5||||||95.0|13.3|24.8||||||Serotype G1|
1749128|NCT00362648|3213991|Superiority or Other||Percentage|78.3||||||95.0|71.7|84.0||||||Anti-rotavirus IgA|
1749129|NCT00362648|3213992|Superiority or Other||Efficacy = 1-Relative Risk|48.3|||<|0.001||95.0|22.3|66.1||Efficacy>0%. Based on p< 1/(1+k), where p is proportion of subjects with outcome in vaccine group relative to total number of subjects with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|The number randomized is different from the number analyzed because some data were excluded from the analysis: subjects were classified as unevaluable due to wildtype rotavirus in stool before 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. Rotavirus gastroenteritis cases are subjects with one or more positive episodes. The most severe positive episode is used for the date of the case.|
1750042|NCT00352417|3215309|Superiority or Other||||||<|0.01|||||||ANCOVA||||
1749130|NCT00362648|3213992|Superiority or Other||Efficacy = 1-Relative Risk|39.3|||<|0.001||95.0|19.1|54.7||Efficacy>0%. Based on p< 1/(1+k), where p is proportion of subjects with outcome in vaccine group relative to total number of subjects with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.|The number randomized is different from the number analyzed because some data were excluded from the analysis: subjects were classified as unevaluable due to wildtype rotavirus in stool before 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. Rotavirus gastroenteritis cases are subjects with one or more positive episodes. The most severe positive episode is used for the date of the case.|
1749131|NCT00362453|3214005|Superiority or Other||Mean Difference (Final Values)|4.77||||0.1|2-Sided|95.0|-1.59|11.13|||Mixed Models Analysis|||48 Weeks|
1749132|NCT00362453|3214005|Superiority or Other||Mean Difference (Final Values)|-0.11||||1|2-Sided|95.0|-6.47|6.25|||Mixed Models Analysis|||24 Weeks|
1749133|NCT00362453|3214005|Superiority or Other||Mean Difference (Final Values)|0.21||||0.9|2-Sided|95.0|-6.15|6.57|||Mixed Models Analysis|||12 Weeks|
1749134|NCT00362453|3214006|Superiority or Other||Mean Difference (Final Values)|6.32||||0.01|2-Sided|95.0|1.38|11.25|||Mixed Models Analysis|||48 Weeks|
1749135|NCT00362453|3214006|Superiority or Other||Mean Difference (Final Values)|4.51||||0.08|2-Sided|95.0|-0.42|9.45|||Mixed Models Analysis|||24 Weeks|
1749136|NCT00362453|3214006|Superiority or Other||Mean Difference (Final Values)|7.43||||0.004|2-Sided|95.0|2.5|12.36|||Mixed Models Analysis|||12 Weeks|
1749137|NCT00362453|3214007|Superiority or Other||Mean Difference (Final Values)|0.96||||0.007|2-Sided|95.0|0.28|1.64|||Mixed Models Analysis|||48 Weeks|
1749138|NCT00362453|3214007|Superiority or Other||Mean Difference (Final Values)|0.85||||0.02|2-Sided|95.0|0.17|1.53|||Mixed Models Analysis|||24 Weeks|
1749139|NCT00362453|3214007|Superiority or Other||Mean Difference (Final Values)|0.71||||0.04|2-Sided|95.0|0.03|1.39|||Mixed Models Analysis|||12 Weeks|
1749140|NCT00362453|3214008|Superiority or Other||Mean Difference (Final Values)|-8.9||||0.0006|2-Sided|95.0|-13.83|-3.97|||Mixed Models Analysis|||48 Week|
1749141|NCT00362453|3214008|Superiority or Other||Mean Difference (Final Values)|-5.3||||0.04|2-Sided|95.0|-10.23|-0.37|||Mixed Models Analysis|||24 Weeks|
1749142|NCT00362453|3214008|Superiority or Other||Mean Difference (Final Values)|-6.7||||0.009|2-Sided|95.0|-11.63|-1.77|||Mixed Models Analysis|||12 Week|
1749143|NCT00362453|3214009|Superiority or Other||Mean Difference (Final Values)|-0.11||||0.6|2-Sided|95.0|-0.55|0.34|||Mixed Models Analysis|||48 weeks|
1749144|NCT00362453|3214009|Superiority or Other||Mean Difference (Final Values)|0.07||||0.7|2-Sided|95.0|-0.37|0.52|||Mixed Models Analysis|||24 Weeks|
1749145|NCT00362453|3214009|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.7|2-Sided|95.0|-0.54|0.34|||Mixed Models Analysis|||12 Weeks|
1749146|NCT00362453|3214010|Superiority or Other||Mean Difference (Final Values)|14.61||||0.7|2-Sided|95.0|-49.36|78.59|||Mixed Models Analysis|||48 Weeks|
1749147|NCT00362453|3214010|Superiority or Other||Mean Difference (Final Values)|43.71||||0.1|2-Sided|95.0|-15.07|102.5|||Mixed Models Analysis|||24 Week|
1749148|NCT00362453|3214010|Superiority or Other||Mean Difference (Final Values)|50.08||||0.1|2-Sided|95.0|-10.34|110.5|||Mixed Models Analysis|||12 Week|
1749149|NCT00362453|3214011|Superiority or Other||Mean Difference (Final Values)|-5.98||||0.02|2-Sided|95.0|-11.06|-0.91|||Mixed Models Analysis|||48 Week|
1749150|NCT00362453|3214011|Superiority or Other||Mean Difference (Final Values)|-5.12||||0.05|2-Sided|95.0|-10.15|-0.08|||Mixed Models Analysis|||24 Week|
1749151|NCT00362453|3214011|Superiority or Other||Mean Difference (Final Values)|-10.88||||5e-05|2-Sided|95.0|-15.91|-5.84|||Mixed Models Analysis|||12 Week|
1749152|NCT00362453|3214012|Superiority or Other||Mean Difference (Final Values)|-1.03||||0.06|2-Sided|95.0|-2.09|0.02|||Mixed Models Analysis|||48 Week|
1749153|NCT00362453|3214012|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.3|2-Sided|95.0|-1.58|0.51|||Mixed Models Analysis|||24 Week|
1749154|NCT00362453|3214012|Superiority or Other||Mean Difference (Final Values)|-1.71||||0.002|2-Sided|95.0|-2.75|-0.66|||Mixed Models Analysis|||12 Week|
1749155|NCT00362453|3214013|Superiority or Other||Mean Difference (Final Values)|0.04||||1|2-Sided|95.0|-1.62|1.7|||Mixed Models Analysis|||48 weeks|
1749156|NCT00362453|3214013|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.4|2-Sided|95.0|-2.31|1.02|||Mixed Models Analysis|||24 Week|
1749157|NCT00362453|3214013|Superiority or Other||Mean Difference (Final Values)|-2.15||||0.01|2-Sided|95.0|-3.82|-0.49|||Mixed Models Analysis|||12 Week|
1749158|NCT00362453|3214014|Superiority or Other||Mean Difference (Final Values)|-46.15||||0.2|2-Sided|95.0|-111.01|18.71|||Mixed Models Analysis|||48 Week|
1749159|NCT00362453|3214014|Superiority or Other||Mean Difference (Final Values)|-66.95||||0.05|2-Sided|95.0|-131.81|-2.09|||Mixed Models Analysis|||24 Week|
1749160|NCT00362453|3214015|Superiority or Other||Mean Difference (Final Values)|-3.65||||0.8|2-Sided|95.0|-33.79|26.49|||Mixed Models Analysis|||48 Week|
1749161|NCT00362453|3214015|Superiority or Other||Mean Difference (Final Values)|-14.8||||0.3|2-Sided|95.0|-44.94|15.34|||Mixed Models Analysis|||24 week|
1749162|NCT00362453|3214015|Superiority or Other||Mean Difference (Final Values)|-22.9||||0.1|2-Sided|95.0|-53.04|7.24|||Mixed Models Analysis|||12 week|
1749163|NCT00362453|3214016|Superiority or Other||Mean Difference (Final Values)|-105.3||||0.3|2-Sided|95.0|-294.68|84.08|||Mixed Models Analysis|||48 week|
1749164|NCT00362453|3214016|Superiority or Other||Mean Difference (Final Values)|-183.2||||0.06|2-Sided|95.0|-372.58|6.18|||Mixed Models Analysis|||24 Week|
1749165|NCT00362453|3214016|Superiority or Other||Mean Difference (Final Values)|-324.6||||0.001|2-Sided|95.0|-513.98|-135.22|||Mixed Models Analysis|||12 Week|
1749166|NCT00362453|3214017|Superiority or Other||Mean Difference (Final Values)|-118.8||||0.0005|2-Sided|95.0|-183.66|-53.94|||Mixed Models Analysis||||
1749872|NCT00356135|3214991|Superiority or Other||||||<|0.0001||||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient||||
1749167|NCT00362401|3214035|Superiority or Other||||||<|0.05|||||||ANOVA|||The comparison of the three valve groups with respect to the objective sound measures was made by the one-way ANOVA method. The null hypothesis is that there is no difference on intensity of heart valve sounds among the three groups.|
1749168|NCT00362375|3214039|Superiority or Other||Odds Ratio (OR)|1.44|||<|0.05|2-Sided|95.0|0.76|2.71|||GEE||||
1749169|NCT00362375|3214040|Superiority or Other||Odds Ratio (OR)|1.07|||<|0.05|2-Sided|95.0|0.8|1.44|||GEE|GEE incident rate ratio|||
1749170|NCT00362375|3214041|Superiority or Other||Odds Ratio (OR)|1.39|||<|0.05|2-Sided|95.0|0.99|1.95|||GEE||||
1749171|NCT00362375|3214042|Superiority or Other||Odds Ratio (OR)|0.48|||<|0.05|2-Sided|95.0|0.2|1.16|||GEE||||
1749172|NCT00362375|3214043|Superiority or Other||Odds Ratio (OR)|2.4|||<|0.05|2-Sided|95.0|1.28|4.5|||Generalized Estimating Equation|||GEE cluster-adjusted odds ratio|
1749173|NCT00362297|3214054|Superiority or Other (legacy)||Incident Risk Ratio|0.79||||0.052||95.0|0.63|1.0|||Regression, Poisson|Adjusted for period effects.||Comparison of genital HSV shedding rate on high dose acyclovir to standard dose valacyclovir. Powered with 80% chance of detecting 50% reduction in genital shedding rate on high dose acyclovir compared to standard dose valacyclovir.|
1749174|NCT00362232|3214055|Superiority or Other||Risk Difference (RD)|0.39||||0.11||95.0|-0.09|0.88|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)|
1749175|NCT00362232|3214056|Non-Inferiority or Equivalence|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided) .|Risk Difference (RD)|-0.98|||<|0.001||95.0|-2.06|0.1|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.|
1749176|NCT00362232|3214056|Superiority or Other||Risk Difference (RD)|-0.98|||<|0.074||95.0|-2.06|0.1|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)|
1749177|NCT00362232|3214057|Non-Inferiority or Equivalence|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.57|||<|0.001||95.0|-1.57|0.44|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.|
1749178|NCT00362232|3214057|Superiority or Other||Risk Difference (RD)|-0.57|||<|0.27||95.0|-1.57|0.44|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)|
1749179|NCT00362232|3214058|Non-Inferiority or Equivalence|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.97|||<|0.001||95.0|-5.42|-0.53|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.|
1749180|NCT00362232|3214058|Superiority or Other||Risk Difference (RD)|-2.97|||<|0.017||95.0|-5.42|-0.53|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)|
1749181|NCT00362232|3214059|Non-Inferiority or Equivalence|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.47|||<|0.001||95.0|-4.49|0.04|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.|
1749182|NCT00362232|3214059|Superiority or Other||Risk Difference (RD)|-2.47|||<|0.054||95.0|-4.99|0.04|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)|
1749183|NCT00362232|3214060|Superiority or Other||Risk Difference (RD)|-0.3||||||95.0|-1.56|0.94|||||Exact methods for difference to Enoxaparin||
1749184|NCT00362232|3214061|Superiority or Other||Risk Difference (RD)|0.11||||||95.0|-0.35|0.56|||||||
1749185|NCT00362232|3214062|Superiority or Other||Risk Difference (RD)|0.24||||||95.0|-0.22|0.71|||||Mantel-Haenszel weighted difference to Enoxaparin||
1749186|NCT00362232|3214063|Superiority or Other||Risk Difference (RD)|-2.67||||||95.0|-5.02|-0.32|||||Mantel-Haenszel weighted difference to Enoxaparin||
1749187|NCT00362232|3214064|Superiority or Other||Risk Difference (RD)|-2.38||||||95.0|-4.84|0.07|||||Mantel-Haenszel weighted difference to Enoxaparin||
1749188|NCT00362232|3214065|Superiority or Other||Risk Difference (RD)|-0.72||||||95.0|-1.81|0.36|||||Mantel-Haenszel weighted difference to Enoxaparin||
1749189|NCT00362232|3214066|Superiority or Other||Risk Difference (RD)|-0.44||||||95.0|-1.59|0.66|||||Mantel-Haenszel weighted difference to Enoxaparin||
1749190|NCT00362232|3214067|Non-Inferiority or Equivalence|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.8|||<|0.001||95.0|-1.82|0.22|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the major VTE in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.|
1749191|NCT00362232|3214067|Superiority or Other||Risk Difference (RD)|-0.8|||<|0.124||95.0|-1.82|0.22|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the major VTE is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)|
1749215|NCT00362115|3214080|Superiority or Other||Mean Difference (Final Values)|-12.6||||0.0001|2-Sided|95.0|-18.96|-6.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749192|NCT00362232|3214068|Non-Inferiority or Equivalence|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-0.37|||<|0.001||95.0|-1.34|0.6|||Mantel Haenszel|weighted treatment differences||Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the major VTE in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.|
1749193|NCT00362232|3214068|Superiority or Other||Risk Difference (RD)|-0.37|||<|0.456||95.0|-1.34|0.6|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the major VTE is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)|
1749194|NCT00362232|3214069|Superiority or Other||Risk Difference (RD)|-3.19||||0.012||95.0|-5.67|-0.71|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: The incidence of the primary efficacy endpoint is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided).|
1749195|NCT00362232|3214070|Superiority or Other||Risk Difference (RD)|-2.71||||0.036||95.0|-5.25|-0.17|||Mantel Haenszel|weighted treatment differences||Null hypothesis: The incidence of the primary efficacy endpoint is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided).|
1749196|NCT00362232|3214070|Non-Inferiority or Equivalence|P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).|Risk Difference (RD)|-2.71|||<|0.001||95.0|-5.25|-0.17|||Mantel Haenszel|weighted treatment differences|Mantel-Haenszel weighted difference to Enoxaparin|Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the primary efficacy endpoint in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.|
1749197|NCT00362180|3214077|Superiority or Other|||||||0.0513|||||||exact Wilcoxon Rank-sum test|||The p-value is a comparison between the placebo group and the mipomersen group in Cohort E as a change from Baseline to Day 99.|
1749198|NCT00362180|3214077|Superiority or Other|||||||0.7244|||||||exact Wilcoxon Rank-sum test|||The p-value is a comparison between the placebo group and the mipomersen group in Cohort E as a change from Baseline to Day 26.|
1749199|NCT00362115|3214079|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.1954|2-Sided|95.0|-6.24|1.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749200|NCT00362115|3214079|Superiority or Other||Mean Difference (Final Values)|-1.5||||0.4345|2-Sided|95.0|-5.36|2.31||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749201|NCT00362115|3214079|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.5967|2-Sided|95.0|-4.59|2.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749202|NCT00362115|3214079|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.3787|2-Sided|95.0|-5.27|2.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749203|NCT00362115|3214079|Superiority or Other||Mean Difference (Final Values)|-2.3||||0.2032|2-Sided|95.0|-5.76|1.23||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749204|NCT00362115|3214079|Superiority or Other||Mean Difference (Final Values)|-3.0||||0.1195|2-Sided|95.0|-6.67|0.77||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749205|NCT00362115|3214079|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.3007|2-Sided|95.0|-5.79|1.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749206|NCT00362115|3214079|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.4247|2-Sided|95.0|-5.01|2.12||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749207|NCT00362115|3214079|Superiority or Other||Mean Difference (Final Values)|-2.1||||0.2494|2-Sided|95.0|-5.69|1.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749208|NCT00362115|3214079|Superiority or Other||Mean Difference (Final Values)|-2.7||||0.1162|2-Sided|95.0|-6.16|0.68||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749209|NCT00362115|3214080|Superiority or Other||Mean Difference (Final Values)|-4.4||||0.1435|2-Sided|95.0|-10.3|1.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749210|NCT00362115|3214080|Superiority or Other||Mean Difference (Final Values)|-6.1||||0.0566|2-Sided|95.0|-12.41|0.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749211|NCT00362115|3214080|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.4279|2-Sided|95.0|-8.34|3.54||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749212|NCT00362115|3214080|Superiority or Other||Mean Difference (Final Values)|-3.7||||0.2115|2-Sided|95.0|-9.61|2.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749213|NCT00362115|3214080|Superiority or Other||Mean Difference (Final Values)|-2.7||||0.3499|2-Sided|95.0|-8.39|2.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749214|NCT00362115|3214080|Superiority or Other||Mean Difference (Final Values)|-10.9||||0.0004|2-Sided|95.0|-16.85|-4.89||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749485|NCT00360568|3214224|Superiority or Other|||||||0.341|||||||t-test, 2 sided||||
1749216|NCT00362115|3214080|Superiority or Other||Mean Difference (Final Values)|-8.9||||0.004|2-Sided|95.0|-14.88|-2.85||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749217|NCT00362115|3214080|Superiority or Other||Mean Difference (Final Values)|-10.2||||0.0008|2-Sided|95.0|-16.15|-4.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749218|NCT00362115|3214080|Superiority or Other||Mean Difference (Final Values)|-9.2||||0.0019|2-Sided|95.0|-14.94|-3.41||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749219|NCT00362115|3214081|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.3669|2-Sided|95.0|-4.59|1.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749220|NCT00362115|3214081|Superiority or Other||Mean Difference (Final Values)|-3.0||||0.0732|2-Sided|95.0|-6.21|0.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749221|NCT00362115|3214081|Superiority or Other||Mean Difference (Final Values)|-2.1||||0.1949|2-Sided|95.0|-5.21|1.07||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749222|NCT00362115|3214081|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.3938|2-Sided|95.0|-4.54|1.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749223|NCT00362115|3214081|Superiority or Other||Mean Difference (Final Values)|0.9||||0.5519|2-Sided|95.0|-2.11|3.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749224|NCT00362115|3214081|Superiority or Other||Mean Difference (Final Values)|-7.6|||<|0.0001|2-Sided|95.0|-10.87|-4.3||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749225|NCT00362115|3214081|Superiority or Other||Mean Difference (Final Values)|-9.1|||<|0.0001|2-Sided|95.0|-12.49|-5.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749226|NCT00362115|3214081|Superiority or Other||Mean Difference (Final Values)|-8.2|||<|0.0001|2-Sided|95.0|-11.51|-4.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749227|NCT00362115|3214081|Superiority or Other||Mean Difference (Final Values)|-7.5|||<|0.0001|2-Sided|95.0|-10.82|-4.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749228|NCT00362115|3214081|Superiority or Other||Mean Difference (Final Values)|-5.2|||<|0.0014|2-Sided|95.0|-8.41|-2.04||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749229|NCT00362115|3214082|Superiority or Other||Mean Difference (Final Values)|-4.6||||0.0402|2-Sided|95.0|-9.06|-0.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749230|NCT00362115|3214082|Superiority or Other||Mean Difference (Final Values)|-5.7||||0.0144|2-Sided|95.0|-10.28|-1.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749231|NCT00362115|3214082|Superiority or Other||Mean Difference (Final Values)|-2.6||||0.2504|2-Sided|95.0|-7.02|1.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749232|NCT00362115|3214082|Superiority or Other||Mean Difference (Final Values)|-3.1||||0.1702|2-Sided|95.0|-7.57|1.34||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749233|NCT00362115|3214082|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.8103|2-Sided|95.0|-4.79|3.75||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749234|NCT00362115|3214082|Superiority or Other||Mean Difference (Final Values)|-12.1|||<|0.0001|2-Sided|95.0|-16.74|-7.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749235|NCT00362115|3214082|Superiority or Other||Mean Difference (Final Values)|-13.2|||<|0.0001|2-Sided|95.0|-17.95|-8.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749236|NCT00362115|3214082|Superiority or Other||Mean Difference (Final Values)|-10.1|||<|0.0001|2-Sided|95.0|-14.7|-5.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749237|NCT00362115|3214082|Superiority or Other||Mean Difference (Final Values)|-10.6|||<|0.0001|2-Sided|95.0|-15.24|-5.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749238|NCT00362115|3214082|Superiority or Other||Mean Difference (Final Values)|-8.0|||<|0.0005|2-Sided|95.0|-12.48|-3.52||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749239|NCT00362115|3214083|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.3132|2-Sided|95.0|-4.96|1.6||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749240|NCT00362115|3214083|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.1678|2-Sided|95.0|-5.77|1.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749241|NCT00362115|3214083|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.6869|2-Sided|95.0|-3.91|2.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749242|NCT00362115|3214083|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.4255|2-Sided|95.0|-4.62|1.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749243|NCT00362115|3214083|Superiority or Other||Mean Difference (Final Values)|1.3||||0.4188|2-Sided|95.0|-1.83|4.4||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749244|NCT00362115|3214083|Superiority or Other||Mean Difference (Final Values)|-9.7|||<|0.0001|2-Sided|95.0|-13.11|-6.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749245|NCT00362115|3214083|Superiority or Other||Mean Difference (Final Values)|-10.4|||<|0.0001|2-Sided|95.0|-13.92|-6.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749246|NCT00362115|3214083|Superiority or Other||Mean Difference (Final Values)|-8.6|||<|0.0001|2-Sided|95.0|-12.05|-5.22||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749247|NCT00362115|3214083|Superiority or Other||Mean Difference (Final Values)|-9.3|||<|0.0001|2-Sided|95.0|-12.76|-5.86||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749248|NCT00362115|3214083|Superiority or Other||Mean Difference (Final Values)|-6.7|||<|0.0001|2-Sided|95.0|-9.98|-3.4||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749249|NCT00362115|3214084|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.7488|2-Sided|95.0|-5.44|3.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749250|NCT00362115|3214084|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.3169|2-Sided|95.0|-7.29|2.37||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749251|NCT00362115|3214084|Superiority or Other||Mean Difference (Final Values)|0.2||||0.9317|2-Sided|95.0|-4.42|4.82||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749252|NCT00362115|3214084|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.8382|2-Sided|95.0|-5.16|4.19||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749253|NCT00362115|3214084|Superiority or Other||Mean Difference (Final Values)|3.3||||0.1479|2-Sided|95.0|-1.17|7.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749254|NCT00362115|3214084|Superiority or Other||Mean Difference (Final Values)|-12.6|||<|0.0001|2-Sided|95.0|-17.53|-7.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749255|NCT00362115|3214084|Superiority or Other||Mean Difference (Final Values)|-14.3|||<|0.0001|2-Sided|95.0|-19.38|-9.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749256|NCT00362115|3214084|Superiority or Other||Mean Difference (Final Values)|-11.6|||<|0.0001|2-Sided|95.0|-16.51|-6.78||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749257|NCT00362115|3214084|Superiority or Other||Mean Difference (Final Values)|-12.3|||<|0.0001|2-Sided|95.0|-17.26|-7.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749258|NCT00362115|3214084|Superiority or Other||Mean Difference (Final Values)|-8.6|||<|0.0004|2-Sided|95.0|-13.28|-3.87||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749259|NCT00362115|3214085|Superiority or Other||Mean Difference (Final Values)|-2.7||||0.0681|2-Sided|95.0|-5.6|0.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749260|NCT00362115|3214085|Superiority or Other||Mean Difference (Final Values)|-4.6||||0.0025|2-Sided|95.0|-7.56|-1.62||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749261|NCT00362115|3214085|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.173|2-Sided|95.0|-4.85|0.88||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749262|NCT00362115|3214085|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.2622|2-Sided|95.0|-4.56|1.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749263|NCT00362115|3214085|Superiority or Other||Mean Difference (Final Values)|1.8||||0.2068|2-Sided|95.0|-0.98|4.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749264|NCT00362115|3214085|Superiority or Other||Mean Difference (Final Values)|-9.4|||<|0.0001|2-Sided|95.0|-12.37|-6.36||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749265|NCT00362115|3214085|Superiority or Other||Mean Difference (Final Values)|-11.3|||<|0.0001|2-Sided|95.0|-14.34|-8.18||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749266|NCT00362115|3214085|Superiority or Other||Mean Difference (Final Values)|-8.7|||<|0.0001|2-Sided|95.0|-11.63|-5.67||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749267|NCT00362115|3214085|Superiority or Other||Mean Difference (Final Values)|-8.3|||<|0.0001|2-Sided|95.0|-11.33|-5.32||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749268|NCT00362115|3214085|Superiority or Other||Mean Difference (Final Values)|-4.9|||<|0.0009|2-Sided|95.0|-7.77|-2.04||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749269|NCT00362115|3214086|Superiority or Other||Mean Difference (Final Values)|-4.5||||0.0429|2-Sided|95.0|-8.77|-0.14||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANOVA||||
1749270|NCT00362115|3214086|Superiority or Other||Mean Difference (Final Values)|-8.7||||0.0001|2-Sided|95.0|-13.08|-4.23||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749271|NCT00362115|3214086|Superiority or Other||Mean Difference (Final Values)|-3.0||||0.1736|2-Sided|95.0|-7.22|1.31||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749272|NCT00362115|3214086|Superiority or Other||Mean Difference (Final Values)|-4.4||||0.0433|2-Sided|95.0|-8.76|-0.13||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749273|NCT00362115|3214086|Superiority or Other||Mean Difference (Final Values)|0.8||||0.6905|2-Sided|95.0|-3.26|4.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749274|NCT00362115|3214086|Superiority or Other||Mean Difference (Final Values)|-13.7|||<|0.0001|2-Sided|95.0|-18.21|-9.25||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749275|NCT00362115|3214086|Superiority or Other||Mean Difference (Final Values)|-17.9|||<|0.0001|2-Sided|95.0|-22.51|-13.35||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749276|NCT00362115|3214086|Superiority or Other||Mean Difference (Final Values)|-12.2|||<|0.0001|2-Sided|95.0|-16.66|-7.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749277|NCT00362115|3214086|Superiority or Other||Mean Difference (Final Values)|-13.7|||<|0.0001|2-Sided|95.0|-18.19|-9.24||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749278|NCT00362115|3214086|Superiority or Other||Mean Difference (Final Values)|-8.4|||<|0.0001|2-Sided|95.0|-12.7|-4.19||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749279|NCT00362115|3214087|Superiority or Other||Mean Difference (Final Values)|0.6||||0.7644|2-Sided|95.0|-3.22|4.38||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749280|NCT00362115|3214087|Superiority or Other||Mean Difference (Final Values)|-4.4||||0.0302|2-Sided|95.0|-8.31|-0.42||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749281|NCT00362115|3214087|Superiority or Other||Mean Difference (Final Values)|0.7||||0.7302|2-Sided|95.0|-3.11|4.43||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749282|NCT00362115|3214087|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.3772|2-Sided|95.0|-5.53|2.1||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749283|NCT00362115|3214087|Superiority or Other||Mean Difference (Final Values)|2.0||||0.279|2-Sided|95.0|-1.63|5.62||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749284|NCT00362115|3214087|Superiority or Other||Mean Difference (Final Values)|-8.7|||<|0.0001|2-Sided|95.0|-12.69|-4.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749285|NCT00362115|3214087|Superiority or Other||Mean Difference (Final Values)|-13.6|||<|0.0001|2-Sided|95.0|-17.79|-9.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749286|NCT00362115|3214087|Superiority or Other||Mean Difference (Final Values)|-8.6|||<|0.0001|2-Sided|95.0|-12.59|-4.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749287|NCT00362115|3214087|Superiority or Other||Mean Difference (Final Values)|-11.0|||<|0.0001|2-Sided|95.0|-15.01|-6.97||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749288|NCT00362115|3214087|Superiority or Other||Mean Difference (Final Values)|-7.3|||<|0.0002|2-Sided|95.0|-11.13|-3.43||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749289|NCT00362115|3214088|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.9647|2-Sided|95.0|-5.44|5.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749290|NCT00362115|3214088|Superiority or Other||Mean Difference (Final Values)|-5.0||||0.076|2-Sided|95.0|-10.55|0.53||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749291|NCT00362115|3214088|Superiority or Other||Mean Difference (Final Values)|1.9||||0.4898|2-Sided|95.0|-3.43|7.15||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749292|NCT00362115|3214088|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.6859|2-Sided|95.0|-6.46|4.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749293|NCT00362115|3214088|Superiority or Other||Mean Difference (Final Values)|2.9||||0.2594|2-Sided|95.0|-2.17|8.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749294|NCT00362115|3214088|Superiority or Other||Mean Difference (Final Values)|-12.4|||<|0.0001|2-Sided|95.0|-18.01|-6.78||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749295|NCT00362115|3214088|Superiority or Other||Mean Difference (Final Values)|-17.3|||<|0.0001|2-Sided|95.0|-23.11|-11.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749296|NCT00362115|3214088|Superiority or Other||Mean Difference (Final Values)|-10.4|||<|0.0003|2-Sided|95.0|-16.0|-4.83||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749297|NCT00362115|3214088|Superiority or Other||Mean Difference (Final Values)|-13.4|||<|0.0001|2-Sided|95.0|-19.02|-7.73||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749298|NCT00362115|3214088|Superiority or Other||Mean Difference (Final Values)|-9.4|||<|0.0007|2-Sided|95.0|-14.74|-3.97||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749299|NCT00362115|3214089|Superiority or Other||Mean Difference (Final Values)|-4.1||||0.0495|2-Sided|95.0|-8.19|-0.01||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749300|NCT00362115|3214089|Superiority or Other||Mean Difference (Final Values)|-4.3||||0.0437|2-Sided|95.0|-8.57|-0.12||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749301|NCT00362115|3214089|Superiority or Other||Mean Difference (Final Values)|-2.6||||0.2082|2-Sided|95.0|-6.72|1.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749302|NCT00362115|3214089|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.6588|2-Sided|95.0|-5.05|3.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749303|NCT00362115|3214089|Superiority or Other||Mean Difference (Final Values)|0.9||||0.6372|2-Sided|95.0|-2.97|4.85||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749304|NCT00362115|3214089|Superiority or Other||Mean Difference (Final Values)|-9.3|||<|0.0001|2-Sided|95.0|-13.6|-5.03||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749305|NCT00362115|3214089|Superiority or Other||Mean Difference (Final Values)|-9.6|||<|0.0001|2-Sided|95.0|-13.97|-5.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749306|NCT00362115|3214089|Superiority or Other||Mean Difference (Final Values)|-7.8|||<|0.0004|2-Sided|95.0|-12.12|-3.56||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749307|NCT00362115|3214089|Superiority or Other||Mean Difference (Final Values)|-6.1|||<|0.0053|2-Sided|95.0|-10.44|-1.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749308|NCT00362115|3214089|Superiority or Other||Mean Difference (Final Values)|-4.3|||<|0.0417|2-Sided|95.0|-8.39|-0.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749309|NCT00362115|3214090|Superiority or Other||Mean Difference (Final Values)|-5.9||||0.0437|2-Sided|95.0|-11.7|-0.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749310|NCT00362115|3214090|Superiority or Other||Mean Difference (Final Values)|-9.7||||0.0016|2-Sided|95.0|-15.61|-3.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749311|NCT00362115|3214090|Superiority or Other||Mean Difference (Final Values)|-4.4||||0.1328|2-Sided|95.0|-10.19|1.35||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749312|NCT00362115|3214090|Superiority or Other||Mean Difference (Final Values)|-3.6||||0.2223|2-Sided|95.0|-9.41|2.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749313|NCT00362115|3214090|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.9355|2-Sided|95.0|-5.74|5.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749314|NCT00362115|3214090|Superiority or Other||Mean Difference (Final Values)|-13.8|||<|0.0001|2-Sided|95.0|-19.86|-7.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749315|NCT00362115|3214090|Superiority or Other||Mean Difference (Final Values)|-17.5|||<|0.0001|2-Sided|95.0|-23.75|-11.34||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749316|NCT00362115|3214090|Superiority or Other||Mean Difference (Final Values)|-12.3|||<|0.0001|2-Sided|95.0|-18.34|-6.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749317|NCT00362115|3214090|Superiority or Other||Mean Difference (Final Values)|-11.5|||<|0.0002|2-Sided|95.0|-17.56|-5.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749318|NCT00362115|3214090|Superiority or Other||Mean Difference (Final Values)|-8.1|||<|0.0061|2-Sided|95.0|-13.9|-2.33||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749319|NCT00362115|3214091|Superiority or Other||Mean Difference (Final Values)|-3.5||||0.0306|2-Sided|95.0|-6.72|-0.33||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749320|NCT00362115|3214091|Superiority or Other||Mean Difference (Final Values)|-4.9||||0.0034|2-Sided|95.0|-8.18|-1.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749321|NCT00362115|3214091|Superiority or Other||Mean Difference (Final Values)|-2.9||||0.0751|2-Sided|95.0|-6.01|0.29||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749322|NCT00362115|3214091|Superiority or Other||Mean Difference (Final Values)|-2.2||||0.1823|2-Sided|95.0|-5.37|1.02||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749323|NCT00362115|3214091|Superiority or Other||Mean Difference (Final Values)|1.6||||0.306|2-Sided|95.0|-1.45|4.59||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749324|NCT00362115|3214091|Superiority or Other||Mean Difference (Final Values)|-9.2|||<|0.0001|2-Sided|95.0|-12.52|-5.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749325|NCT00362115|3214091|Superiority or Other||Mean Difference (Final Values)|-10.6|||<|0.0001|2-Sided|95.0|-13.98|-7.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749326|NCT00362115|3214091|Superiority or Other||Mean Difference (Final Values)|-8.5|||<|0.0001|2-Sided|95.0|-11.82|-5.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749327|NCT00362115|3214091|Superiority or Other||Mean Difference (Final Values)|-7.9|||<|0.0001|2-Sided|95.0|-11.16|-4.55||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749328|NCT00362115|3214091|Superiority or Other||Mean Difference (Final Values)|-4.1|||<|0.0108|2-Sided|95.0|-7.26|-0.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749329|NCT00362115|3214092|Superiority or Other||Mean Difference (Final Values)|-5.7||||0.0175|2-Sided|95.0|-10.33|-1.0||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749330|NCT00362115|3214092|Superiority or Other||Mean Difference (Final Values)|-9.9|||<|0.0001|2-Sided|95.0|-14.63|-5.07||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749331|NCT00362115|3214092|Superiority or Other||Mean Difference (Final Values)|-4.4|||<|0.0612|2-Sided|95.0|-9.01|0.21||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749332|NCT00362115|3214092|Superiority or Other||Mean Difference (Final Values)|-5.6|||<|0.0189|2-Sided|95.0|-10.26|-0.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749333|NCT00362115|3214092|Superiority or Other||Mean Difference (Final Values)|0.2|||<|0.9424|2-Sided|95.0|-4.25|4.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749334|NCT00362115|3214092|Superiority or Other||Mean Difference (Final Values)|-13.7|||<|0.0001|2-Sided|95.0|-18.52|-8.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749335|NCT00362115|3214092|Superiority or Other||Mean Difference (Final Values)|-17.9|||<|0.0001|2-Sided|95.0|-22.83|-12.92||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749336|NCT00362115|3214092|Superiority or Other||Mean Difference (Final Values)|-12.4|||<|0.0001|2-Sided|95.0|-17.21|-7.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749337|NCT00362115|3214092|Superiority or Other||Mean Difference (Final Values)|-13.6|||<|0.0001|2-Sided|95.0|-18.46|-8.77||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749338|NCT00362115|3214092|Superiority or Other||Mean Difference (Final Values)|-7.9|||<|0.0009|2-Sided|95.0|-12.46|-3.26||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749339|NCT00362115|3214093|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.145|2-Sided|95.0|-4.77|0.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749340|NCT00362115|3214093|Superiority or Other||Mean Difference (Final Values)|-3.4||||0.0184|2-Sided|95.0|-6.18|-0.57||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749341|NCT00362115|3214093|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.3574|2-Sided|95.0|-3.97|1.44||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749342|NCT00362115|3214093|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.4542|2-Sided|95.0|-3.79|1.7||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749343|NCT00362115|3214093|Superiority or Other||Mean Difference (Final Values)|2.0||||0.1249|2-Sided|95.0|-0.56|4.61||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749344|NCT00362115|3214093|Superiority or Other||Mean Difference (Final Values)|-9.5|||<|0.0001|2-Sided|95.0|-12.31|-6.64||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749345|NCT00362115|3214093|Superiority or Other||Mean Difference (Final Values)|-10.8|||<|0.0001|2-Sided|95.0|-13.73|-7.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749346|NCT00362115|3214093|Superiority or Other||Mean Difference (Final Values)|-8.7|||<|0.0001|2-Sided|95.0|-11.52|-5.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749347|NCT00362115|3214093|Superiority or Other||Mean Difference (Final Values)|-8.5|||<|0.0001|2-Sided|95.0|-11.33|-5.65||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749348|NCT00362115|3214093|Superiority or Other||Mean Difference (Final Values)|-5.4|||<|0.0001|2-Sided|95.0|-8.12|-2.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749349|NCT00362115|3214094|Superiority or Other||Mean Difference (Final Values)|-3.1||||0.1303|2-Sided|95.0|-7.18|0.93||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749350|NCT00362115|3214094|Superiority or Other||Mean Difference (Final Values)|-6.5||||0.0022|2-Sided|95.0|-10.67|-2.36||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749351|NCT00362115|3214094|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.3629|2-Sided|95.0|-5.86|2.15||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749352|NCT00362115|3214094|Superiority or Other||Mean Difference (Final Values)|-2.9||||0.1668|2-Sided|95.0|-6.91|1.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749353|NCT00362115|3214094|Superiority or Other||Mean Difference (Final Values)|1.7||||0.3735|2-Sided|95.0|-2.1|5.58||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749354|NCT00362115|3214094|Superiority or Other||Mean Difference (Final Values)|-13.4|||<|0.0001|2-Sided|95.0|-17.58|-9.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749355|NCT00362115|3214094|Superiority or Other||Mean Difference (Final Values)|-16.8|||<|0.0001|2-Sided|95.0|-21.07|-12.46||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749356|NCT00362115|3214094|Superiority or Other||Mean Difference (Final Values)|-12.1|||<|0.0001|2-Sided|95.0|-16.27|-7.95||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749357|NCT00362115|3214094|Superiority or Other||Mean Difference (Final Values)|-13.1|||<|0.0001|2-Sided|95.0|-17.31|-8.9||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749358|NCT00362115|3214094|Superiority or Other||Mean Difference (Final Values)|-8.5|||<|0.0001|2-Sided|95.0|-12.51|-4.51||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749359|NCT00362115|3214095|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.8133|2-Sided|95.0|-3.67|2.88||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749360|NCT00362115|3214095|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.7646|2-Sided|95.0|-3.79|2.79||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749361|NCT00362115|3214095|Superiority or Other||Mean Difference (Final Values)|0.6||||0.7292|2-Sided|95.0|-2.69|3.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749362|NCT00362115|3214095|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.8973|2-Sided|95.0|-3.49|3.06||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749363|NCT00362115|3214095|Superiority or Other||Mean Difference (Final Values)|1.6||||0.3416|2-Sided|95.0|-1.68|4.84||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749364|NCT00362115|3214095|Superiority or Other||Mean Difference (Final Values)|-4.3||||0.0113|2-Sided|95.0|-7.68|-0.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749365|NCT00362115|3214095|Superiority or Other||Mean Difference (Final Values)|-4.4||||0.0098|2-Sided|95.0|-7.81|-1.08||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749366|NCT00362115|3214095|Superiority or Other||Mean Difference (Final Values)|-3.4||||0.048|2-Sided|95.0|-6.7|-0.03||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749367|NCT00362115|3214095|Superiority or Other||Mean Difference (Final Values)|-4.2||||0.0151|2-Sided|95.0|-7.5|-0.81||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749368|NCT00362115|3214095|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.1653|2-Sided|95.0|-5.69|0.98||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749369|NCT00362115|3214096|Superiority or Other||Mean Difference (Final Values)|-2.6||||0.3059|2-Sided|95.0|-7.54|2.37||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749370|NCT00362115|3214096|Superiority or Other||Mean Difference (Final Values)|-3.2||||0.2107|2-Sided|95.0|-8.15|1.8||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749371|NCT00362115|3214096|Superiority or Other||Mean Difference (Final Values)|-4.7||||0.0646|2-Sided|95.0|-9.59|0.28||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749372|NCT00362115|3214096|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.4213|2-Sided|95.0|-6.96|2.92||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749373|NCT00362115|3214096|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9909|2-Sided|95.0|-4.96|4.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749374|NCT00362115|3214096|Superiority or Other||Mean Difference (Final Values)|-10.7|||<|0.0001|2-Sided|95.0|-15.75|-5.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749375|NCT00362115|3214096|Superiority or Other||Mean Difference (Final Values)|-11.3|||<|0.0001|2-Sided|95.0|-16.36|-6.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749376|NCT00362115|3214096|Superiority or Other||Mean Difference (Final Values)|-12.8|||<|0.0001|2-Sided|95.0|-17.8|-7.72||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749377|NCT00362115|3214096|Superiority or Other||Mean Difference (Final Values)|-10.1|||<|0.0001|2-Sided|95.0|-15.17|-5.09||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749378|NCT00362115|3214096|Superiority or Other||Mean Difference (Final Values)|-8.1|||<|0.0016|2-Sided|95.0|-13.17|-3.09||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749379|NCT00362115|3214097|Superiority or Other||Mean Difference (Final Values)|0.2||||0.9315|2-Sided|95.0|-4.41|4.82||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749380|NCT00362115|3214097|Superiority or Other||Mean Difference (Final Values)|-3.6||||0.1298|2-Sided|95.0|-8.25|1.06||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749381|NCT00362115|3214097|Superiority or Other||Median Difference (Final Values)|-1.1||||0.6293|2-Sided|95.0|-5.75|3.48||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749382|NCT00362115|3214097|Superiority or Other||Mean Difference (Final Values)|-2.1||||0.3688|2-Sided|95.0|-6.74|2.51||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749383|NCT00362115|3214097|Superiority or Other||Mean Difference (Final Values)|2.6||||0.2768|2-Sided|95.0|-2.06|7.17||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749384|NCT00362115|3214097|Superiority or Other||Mean Difference (Final Values)|-8.5||||0.0005|2-Sided|95.0|-13.19|-3.76||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749385|NCT00362115|3214097|Superiority or Other||Mean Difference (Final Values)|-12.3|||<|0.0001|2-Sided|95.0|-17.02|-7.52||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749386|NCT00362115|3214097|Superiority or Other||Mean Difference (Final Values)|-9.8|||<|0.0001|2-Sided|95.0|-14.53|-5.1||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749387|NCT00362115|3214097|Superiority or Other||Mean Difference (Final Values)|-10.8|||<|0.0001|2-Sided|95.0|-15.51|-6.08||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749388|NCT00362115|3214097|Superiority or Other||Mean Difference (Final Values)|-6.1|||<|0.0111|2-Sided|95.0|-10.84|-1.41||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749389|NCT00362115|3214098|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.7294|2-Sided|95.0|-3.52|2.47||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749390|NCT00362115|3214098|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.1001|2-Sided|95.0|-5.55|0.49||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749391|NCT00362115|3214098|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.7469|2-Sided|95.0|-3.49|2.5||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749392|NCT00362115|3214098|Superiority or Other||Mean Difference (Final Values)|-2.1||||0.1719|2-Sided|95.0|-5.08|0.91||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749393|NCT00362115|3214098|Superiority or Other||Mean Difference (Final Values)|0.3||||0.855||95.0|-2.72|3.27||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749394|NCT00362115|3214098|Superiority or Other||Mean Difference (Final Values)|-3.7||||0.0177|2-Sided|95.0|-6.77|-0.65||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749395|NCT00362115|3214098|Superiority or Other||Mean Difference (Final Values)|-5.7||||0.0003|2-Sided|95.0|-8.8|-2.63||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749396|NCT00362115|3214098|Superiority or Other||Mean Difference (Final Values)|-3.7||||0.0188|2-Sided|95.0|-6.73|-0.61||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749397|NCT00362115|3214098|Superiority or Other||Mean Difference (Final Values)|-5.3||||0.0008|2-Sided|95.0|-8.33|-2.2||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749398|NCT00362115|3214098|Superiority or Other||Mean Difference (Final Values)|-2.9||||0.0631|2-Sided|95.0|-5.96|0.16||P-value from analysis of covariance with terms for treatment (as a factor) and baseline value (as a covariate). Unadjusted p-value is presented.|ANCOVA||||
1749399|NCT00361972|3214099|Superiority or Other|||||||0.17|||||||Wilcoxon (Mann-Whitney)||||
1749400|NCT00361972|3214100|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1749401|NCT00361439|3214129|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1749402|NCT00361439|3214130|Superiority or Other||||||<|0.002|||||||t-test, 2 sided||||
1749403|NCT00361439|3214131|Superiority or Other||||||<|0.023|||||||Wilcoxon (Mann-Whitney)||||
1749404|NCT00361439|3214132|Superiority or Other||||||<|0.02|||||||Wilcoxon (Mann-Whitney)||||
1749405|NCT00361335|3214134|Superiority or Other|||||||0.788||||||No adjustments were made to control for multiplicity|2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.|
1749406|NCT00361335|3214134|Superiority or Other|||||||0.738|||||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups II vs V at 0.05 level of significance.|
1749407|NCT00361335|3214134|Superiority or Other|||||||0.996|||||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I and VII at 0.05 level of significance.|
1749408|NCT00361335|3214134|Superiority or Other|||||||0.014|||||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups III vs V at 0.05 level of significance.|
1749409|NCT00361335|3214134|Superiority or Other|||||||0.014|||||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups I vs V at 0.05 level of significance.|
1749410|NCT00361335|3214134|Superiority or Other|||||||0.005|||||||2-sided ANOVA on van der Waerden|||Hypothesis: Null hypothesis: No difference in change from baseline in PCS score of SF-36 at Wk 14 comparing Groups V vs VI at 0.05 level of significance.|
1749411|NCT00361335|3214135|Superiority or Other|||||||0.001|||||||2-sided Cochran-Mantel-Haenszel|No adjustments were made to control for multiplicity||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.|
1749412|NCT00361335|3214135|Superiority or Other|||||||0.003|||||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups II vs V at 0.05 level of significance.|
1749413|NCT00361335|3214135|Superiority or Other||||||<|0.001|||||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VII at 0.05 level of significance.|
1749414|NCT00361335|3214135|Superiority or Other||||||<|0.001|||||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups III vs V at 0.05 level of significance.|
1749415|NCT00361335|3214135|Superiority or Other||||||<|0.001|||||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups I vs V at 0.05 level of significance.|
1749416|NCT00361335|3214135|Superiority or Other||||||<|0.001|||||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in DAS28 response using CRP at Wk 14 comparing Groups V vs VI at 0.05 level of significance.|
1749417|NCT00361335|3214136|Superiority or Other||||||<|0.001|||||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.|
1749418|NCT00361335|3214136|Superiority or Other||||||<|0.043|||||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups II vs V at 0.05 level of significance.|
1749419|NCT00361335|3214136|Superiority or Other||||||<|0.002|||||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VII at 0.05 level of significance.|
1749420|NCT00361335|3214136|Superiority or Other||||||<|0.001|||||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups III vs V at 0.05 level of significance.|
1749421|NCT00361335|3214136|Superiority or Other||||||<|0.001|||||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs V at 0.05 level of significance.|
1749422|NCT00361335|3214136|Superiority or Other||||||<|0.001|||||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance.|
1749423|NCT00361335|3214137|Superiority or Other|||||||0.54|||||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance.|
1749424|NCT00361335|3214137|Superiority or Other|||||||0.844|||||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups II vs V at 0.05 level of significance.|
1749425|NCT00361335|3214137|Superiority or Other|||||||0.795|||||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VII at 0.05 level of significance.|
1749426|NCT00361335|3214137|Superiority or Other||||||<|0.001|||||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups III vs V at 0.05 level of significance.|
1749427|NCT00361335|3214137|Superiority or Other||||||<|0.032|||||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups I vs V at 0.05 level of significance.|
1749428|NCT00361335|3214137|Superiority or Other||||||<|0.002|||||||2-sided Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 50 response at Week 24 comparing Groups V vs VI at 0.05 level of significance.|
1749429|NCT00361335|3214138|Superiority or Other|||||||0.175|||||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs I, V vs III, V vs II, and V vs IV at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and ~29-31 percentage response in the combined group (I and III) at α = 0.05.|
1749430|NCT00361335|3214138|Superiority or Other|||||||0.872|||||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups II vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and ~29-31 percentage response in the Group II at α = 0.05.|
1749431|NCT00361335|3214138|Superiority or Other|||||||0.465|||||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups VII vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and ~29-31 percentage response in the Group VII at α = 0.05.|
1749432|NCT00361335|3214138|Superiority or Other|||||||0.093|||||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups III vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and ~29-31 percentage response in the Group III at α = 0.05.|
1749433|NCT00361335|3214138|Superiority or Other|||||||0.073|||||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups I vs V at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and ~29-31% response in the Group I at α = 0.05.|
1749434|NCT00361335|3214138|Superiority or Other|||||||0.051|||||||2-sided Cochran-Mantel-Haenszel|||Hypothesis: Null hypothesis: No difference in ACR 50 response at Wk 14 comparing Groups V vs VI at 0.05 level of significance. Sample size: The sample size of 125 patients in each of the 5 randomized groups will provide at least 90 percentage power to detect a difference in the ACR 50 response rates between groups assuming 13 percentage response in Group V and ~29-31 percentage response in the Group VI at α = 0.05.|
1749435|NCT00361283|3214143|Superiority or Other||Mean Difference (Net)|-111.0|Standard Error of the Mean|76.7||0.15|2-Sided|95.0|-264.0|42.0||No confounders were controlled for as each person is his/her own control.|t-test, 2 sided|||The study in healthy volunteers was to compare levels at baseline to 16 weeks in ENA-78, a cytokine. The one sample t-test was used to obtain the result.|
1749436|NCT00361257|3214147|Superiority or Other||Slope|0.055|Standard Error of the Mean|0.137||0.69|2-Sided|95.0|-0.217|0.327||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate frontal systems score.||The null hypothesis was the 24 week change of alternate frontal systems score in the minocycline group was the same as the one in the placebo group.|
1749437|NCT00361257|3214148|Superiority or Other||Slope|0.146|Standard Error of the Mean|0.207||0.484|2-Sided|95.0|-0.266|0.558||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, baseline CNS penetration score, and the baseline alternate verbal memory score.||The null hypothesis was that the 24 week change in the alternate verbal memory score in the minocycline group was the same as the one in the placebo group.|
1749438|NCT00361257|3214149|Superiority or Other||Slope|-0.097|Standard Error of the Mean|0.146||0.506|2-Sided|95.0|-0.388|0.193||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline alternate psychomotor function score.||The null hypothesis was that the 24 week change in alternate psychomotor function score in the minocycline group was the same as the one in the placebo group.|
1749439|NCT00361257|3214154|Superiority or Other||Slope|-0.405|Standard Error of the Mean|0.391||0.304|2-Sided|95.0|-1.182|0.373||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline medication management score.||The null hypothesis was that the 24 change of medication management test score in the minocycline group was the same as the one in the placebo group.|
1749486|NCT00360568|3214225|Superiority or Other|||||||0.67|||||||t-test, 2 sided||||
1749487|NCT00360568|3214226|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1749488|NCT00360568|3214227|Superiority or Other|||||||0.583|||||||t-test, 2 sided||||
1749440|NCT00361257|3214155|Superiority or Other||Odds Ratio (OR)|1.071|Standard Error of the Mean|0.497||0.89|2-Sided|95.0|0.405|2.837||The p-value was not adjusted for multiple comparisons.|Regression, Logistic|The model was adjusted for the stratification variables and the baseline CNS penetration score.||The null hypothesis was that the proportion of participants who got better at week 24 compared to baseline in the minocycline group was the same as the one in the placebo group.|
1749441|NCT00361257|3214157|Superiority or Other|||||||0.967|||||||Log Rank|||The null hypothesis was that the time to Grade 2 or higher toxicity and/or signs and symptoms in the minocycline group was the same as the one in the placebo group.|
1749442|NCT00361257|3214158|Superiority or Other||Slope|40.43|Standard Error of the Mean|59.91||0.502|2-Sided|95.0|-79.12|159.97||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline CD8 cell counts.||The null hypothesis was that the 24 week change in CD8 cell count in the minocycline group was the same as the one in the placebo group.|
1749443|NCT00361257|3214159|Superiority or Other||Slope|19.09|Standard Error of the Mean|33.75||0.574|2-Sided|95.0|-48.26|86.44||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the baseline CNS score, and the baseline CD4 cell count.||The null hypothesis was that the 24 week change in CD4 cell counts in the minocycline group was the same as the one in the placebo group.|
1749444|NCT00361257|3214160|Superiority or Other||Odds Ratio (OR)|2.476|Standard Deviation|1.048||0.234|2-Sided|95.0|0.575|10.668||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the CNS penetration score. The stratification variables could not be included in the model since the model fit was poor.||"The null hypothesis was that the proportion of being better at 24 weeks in minocycline group was the same as in the placebo group."|
1749445|NCT00361257|3214161|Superiority or Other||Slope|-0.126|Standard Error of the Mean|0.172||0.467|2-Sided|95.0|-0.467|0.216||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline frontal systems function domain score.||The null hypothesis was that the 24 week change of frontal systems function domain score in the minocycline group was the same as the one in the placebo group.|
1749446|NCT00361257|3214162|Superiority or Other||Slope|0.145|Standard Error of the Mean|0.207||0.484|2-Sided|95.0|-0.266|0.558||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the baseline CNS penetration score, and the baseline verbal memory domain score.||The null hypothesis was that the 24 week change of verbal memory domain score in the minocycline group was the same as the one in the placebo group.|
1749447|NCT00361257|3214163|Superiority or Other||Slope|-0.074|Standard Error of the Mean|0.236||0.754|2-Sided|95.0|-0.544|0.396||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline information processing function domain score.||The null hypothesis was that the 24 week change of information processing function domain score in the minocycline group was the same as the one in the placebo group.|
1749448|NCT00361257|3214164|Superiority or Other||Slope|-0.086|Standard Error of the Mean|0.182||0.637|2-Sided|95.0|-0.449|0.276||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor/nonverbal function domain score.||The null hypothesis was that the 24 week change of fine motor/nonverbal function domain score in the minocycline group was the same as in the placebo group.|
1749449|NCT00361257|3214165|Superiority or Other||Slope|-0.083|Standard Error of the Mean|0.147||0.572|2-Sided|95.0|-0.375|0.209||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratified variables, the baseline CNS penetration score, and the baseline psychomotor function domain score.||The null hypothesis was that the 24 change of psychomotor function domain score in the minocycline group is the same as in the placebo group.|
1749450|NCT00361257|3214166|Superiority or Other||Slope|0.293|Standard Error of the Mean|0.153||0.059|2-Sided|95.0|-0.011|0.596||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline fine motor function domain score.||The null hypothesis was that the 24 week change in fine motor function domain score in the minocycline group was the same as the one in the placebo group.|
1749451|NCT00361257|3214167|Superiority or Other||Slope|0.502|Standard Error of the Mean|0.428||0.243|2-Sided|95.0|-0.349|1.354||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for the stratification variables, the CNS penetration score, and the baseline cognitive gross motor function domain score.||The null hypothesis is that the 24 week change in the cognitive gross motor function domain score in the minocycline group is the same as the one in the placebo group.|
1749452|NCT00361257|3214168|Superiority or Other||Odds Ratio (OR)|1.569|Standard Deviation|0.469||0.337|2-Sided|95.0|0.625|3.936||The p-value was not adjusted for multiple comparisons.|Regression, Cumulative Logistic|The model was adjusted for the stratification variables and the CNS penetration score.||The null hypothesis is that the 24 week changes of participants' clinical status in the minocycline group were the same as the ones in the placebo group based on ICGIS.|
1749453|NCT00361257|3214169|Superiority or Other||Slope|0.091|Standard Error of the Mean|0.116||0.434|2-Sided|95.0|-0.14|0.323||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the CNS penetration score, and the baseline GDS score.||The null hypothesis was that the 24-week changes in Global Deficit Score (GDS) between the minocycline and placebo groups are the same.|
1749454|NCT00361257|3214170|Superiority or Other||Slope|0.064|Standard Error of the Mean|0.164||0.651|2-Sided|95.0|-0.258|0.386||The p-value was not adjusted for multiple comparisons.|Regression, Linear|The model was adjusted for stratification variables, the CNS penetration score, and the baseline NPZ-8 score.|The total number used for the statistical analysis was 107 (52 in the minocycline arm and 55 in the placebo arm).|The null hypothesis was that the 24-week change of NPZ-8 in the minocycline group was the same as the one in the placebo group.|
1749455|NCT00361231|3214171|Superiority or Other|||||||0.05|||||||Kaplan-Meier||||
1749456|NCT00361231|3214172|Superiority or Other||||||<|0.05|||||||Kaplan-Meier||||
1749489|NCT00360568|3214228|Superiority or Other|||||||0.571|||||||t-test, 2 sided||||
1749457|NCT00361140|3214175|Superiority or Other||Hazard Ratio (HR)|6.27||||0.07|2-Sided|95.0|0.92|42.48|||Gray|Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16:1141-1154.||Sample size: dependent on dose escalation. Once the maximum tolerated dose (MTD) is reached, a total of 30 patients will be accrued to that level. If maximally tolerated AUC is level 1, a total of 30 patients will be treated on this level using tacrolimus and methotrexate as GVHD prophylaxis. This will provide 95% confidence intervals for 100-day non-relapse mortality and non-fatal toxicities with ½ widths not exceeding 0.18. Hazard ratios were calculated per the method of Gray (reference given)|
1749458|NCT00361140|3214176|Superiority or Other|||||||0.007|||||||Chi-squared||||
1749459|NCT00360724|3214188|Other||Mean Difference (Final Values)|0.4||||0.9|2-Sided||||||t-test, 2 sided||||
1749460|NCT00360724|3214189|Other||Mean Difference (Final Values)|4.0||||0.002|2-Sided||||||t-test, 2 sided||||
1749461|NCT00360724|3214194|Superiority or Other||F statistics|0.26||||0.6|||||||Repeated measures ANOVA|d.f.=1,55||Repeated measures ANOVA was used to compare measures between baseline and week 10.|
1749462|NCT00360724|3214195|Superiority or Other||F statistics|5.33||||0.025|||||||Repeated measures ANOVA|d.f. 1,55||Repeated measures ANOVA was used to compare measures between baseline and week 10.|
1749463|NCT00360724|3214196|Superiority or Other||F statistics|8.72||||0.05|||||||Repeated Measures ANOVA|d.f. 1,55|Time x Treatment: F=8.72, d.f=1,55, p=0.05|Repeated measures ANOVA was used to compare measures between baseline and week 10.|
1749464|NCT00360724|3214198|Superiority or Other||F statistics|9.43||||0.003|||||||Repeated Measures ANOVA|df 1,55|time X Drug group, f=9.43,df 1,55, p=.003|Repeated measures ANOVA was used to compare measures between baseline and week 10.|
1749465|NCT00360698|3214199|Superiority or Other|||||||0.192||||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of severe symptomatic hypoglycemia during the treatment period.|
1749466|NCT00360698|3214200|Superiority or Other|||||||0.302||||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of nocturnal symptomatic hypoglycemia with plasma glucose <70 mg/dL during the treatment period.|
1749467|NCT00360698|3214201|Superiority or Other|||||||0.958||||||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|Wilcoxon (Mann-Whitney)|||The null-hypothesis stated no difference between the 2 treatment groups regarding the rate of symptomatic hypoglycemia with plasma glucose <70 mg/dL during the treatment period.|
1749468|NCT00360698|3214204|Superiority or Other||Mean Difference (Net)|0.24|Standard Error of the Mean|0.431||0.5762||95.0|-0.61|1.1||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline weight as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the adjusted mean change from baseline in weight at the end of treatment.|
1749469|NCT00360698|3214205|Superiority or Other||Mean Difference (Net)|-12.94|Standard Error of the Mean|4.987||0.0109||95.0|-22.83|-3.04||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline daily mean plasma glucose as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the adjusted mean change from baseline in daily mean plasma glucose at the end of treatment.|
1749470|NCT00360698|3214207|Superiority or Other||Mean Difference (Net)|-0.26|Standard Error of the Mean|0.116||0.029||95.0|-0.49|-0.03||Threshold for statistical significance (alpha) = 0.05 ; 2 sided-test|ANCOVA|The analysis is an ANCOVA analysis on the change with group as fixed effect and baseline HbA1c as covariate|Difference between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no difference between the 2 treatment groups regarding the adjusted mean change from baseline in Glycosylated Haemoglobin (HbA1c) at the end of treatment.|
1749471|NCT00360698|3214209|Superiority or Other||Risk Difference (RD)|13.68||||0.0499||95.0|0.01|28.37|||Chi-squared||Difference in percentage between groups: Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group - Insulin Glargine+Metformin+Glimepiride group|The null-hypothesis stated no differences between the 2 treatment groups regarding the percentage of patients with Glycosylated Haemoglobin (HbA1c) level <7%. A sample size of 98 randomized (49/arm) patients would allow to demonstrate with 80% power that 40 % of patients in the Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride group would achieve a HbA1c level < 7 % compared to 15 % of patients in the Insulin Glargine+Metformin+Glimepiride group(5% alpha risk, 2-sided test).|
1749472|NCT00360685|3214210|Superiority or Other|||||||0.58|||||||Log Rank||||
1749473|NCT00360685|3214211|Superiority or Other|||||||0.8|||||||K-sample tests for comparing the cumulat||||
1749474|NCT00360685|3214212|Superiority or Other|||||||0.06|||||||Fisher Exact|||Sample size was based on the difference in the proportion of patients in each arm who were predicted to develop severe mucositis defined as clinical grade 3 or 4 per the CTCAE. A sample-size of 42 evaluable subjects per study-arm allowed detection of an absolute difference of 30%, which corresponds to a reduction in the incidence of severe mucositis from 60% in the methotrexate arm to 30% in the MMF arm (alpha=0.05, power=0.80).|
1749475|NCT00360568|3214214|Superiority or Other|||||||0.899|||||||t-test, 2 sided||||
1749476|NCT00360568|3214215|Superiority or Other|||||||0.459|||||||t-test, 2 sided||||
1749477|NCT00360568|3214216|Superiority or Other|||||||0.759|||||||t-test, 2 sided||||
1749478|NCT00360568|3214217|Superiority or Other|||||||0.65|||||||t-test, 2 sided||||
1749479|NCT00360568|3214218|Superiority or Other|||||||0.104|||||||t-test, 2 sided||||
1749480|NCT00360568|3214219|Superiority or Other|||||||0.258|||||||t-test, 2 sided||||
1749481|NCT00360568|3214220|Superiority or Other|||||||0.922|||||||t-test, 2 sided||||
1749482|NCT00360568|3214221|Superiority or Other|||||||0.259|||||||t-test, 2 sided||||
1749483|NCT00360568|3214222|Superiority or Other|||||||0.174|||||||t-test, 2 sided||||
1749484|NCT00360568|3214223|Superiority or Other|||||||0.22|||||||t-test, 2 sided||||
1749496|NCT00360529|3214250|Superiority or Other||Percentage responders|38.6||||0.0059||95.0|32.6|44.6|||Cochran-Mantel-Haenszel|Model includes treatment and centre||Flibanserin 50 mg qhs versus placebo|
1749497|NCT00360529|3214250|Superiority or Other||Percentage responders|34.7||||0.0513||95.0|29.0|40.4|||Cochran-Mantel-Haenszel|Model includes treatment and centre||Flibanserin 25 mg bid versus placebo|
1749498|NCT00360529|3214251|Superiority or Other||Mean Difference (Final Values)|2.5||||0.0001||95.0|1.4|3.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo|
1749499|NCT00360529|3214251|Superiority or Other||Mean Difference (Final Values)|1.5||||0.0071||95.0|0.4|2.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo|
1749500|NCT00360529|3214252|Superiority or Other||Mean Difference (Final Values)|0.4||||0.0001||95.0|0.2|0.5|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo|
1749501|NCT00360529|3214252|Superiority or Other||Mean Difference (Final Values)|0.2||||0.0173||95.0|0.0|0.4|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo|
1749502|NCT00360529|3214253|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.0001||95.0|-0.5|-0.2||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo|
1749503|NCT00360529|3214253|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.1144||95.0|-0.3|0.0||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo|
1749504|NCT00360529|3214254|Superiority or Other||Mean Difference (Final Values)|-3.9||||0.0001||95.0|-5.6|-2.2||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo|
1749505|NCT00360529|3214254|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.1601||95.0|-2.9|0.5||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo|
1749506|NCT00360529|3214255|Superiority or Other||Mean Difference (Final Values)|2.2||||0.066||95.0|-0.1|4.6|||ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 100 mg qhs versus placebo|
1749507|NCT00360529|3214255|Superiority or Other||Mean Difference (Final Values)|1.3||||0.2606||95.0|-1.0|3.7||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|ANCOVA|Model includes treatment, centre and baseline as a covariate||Flibanserin 50 mg qhs versus placebo|
1749508|NCT00360529|3214256|Superiority or Other|||||||0.0024||||||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|Wilcoxon (Mann-Whitney)|||Flibanserin 100 mg qhs versus placebo|
1749509|NCT00360529|3214256|Superiority or Other|||||||0.0454||||||Hierarchical ordering used for multiple endpoints, and Hochberg used for multiple dose comparisons. P-values ordered (p1≤p2). If p2≤0.05 then all doses significant. If p1≤0.025 then reject null for p1|Wilcoxon (Mann-Whitney)|||Flibanserin 50 mg qhs versus placebo|
1749510|NCT00360490|3214257|Superiority or Other||Risk Difference (RD)|26.06||||||95.0|14.75|37.36||||||A two-sided 95% confidence interval for the improvement rate will be provided for cycle 6|
1749511|NCT00360490|3214267|Superiority or Other||Mean Difference (Final Values)|-50.6|||<|0.001||95.0|-63.8|-37.4|||t-test, 2 sided|||The null hypothesis: the percent change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.|
1749512|NCT00360490|3214268|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the absolute change from Baseline MBL to Mid-study MBL is equal in the LNG IUS group and the MPA group.|
1749513|NCT00360490|3214269|Superiority or Other||Mean Difference (Final Values)|-49.2|||<|0.001||95.0|-70.2|-28.3|||t-test, 2 sided|||The null hypothesis: the percent change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.|
1749514|NCT00360490|3214270|Superiority or Other||Risk Difference (RD)|62.59|||<|0.001||95.0|50.56|74.61|||Chi-squared|||The null hypothesis: the proportion of subjects with successful treatment is equal in the LNG IUS group and the MPA group.|
1749515|NCT00360490|3214271|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis: the absolute change from Baseline MBL to End of Study MBL is equal in the LNG IUS group and the MPA group.|
1749516|NCT00360334|3214284|Superiority or Other|||||||0.74|||||||ANCOVA on ranks||||
1749517|NCT00360334|3214285|Superiority or Other||||||<|0.001|||||||ANCOVA on ranks||||
1749518|NCT00360334|3214286|Superiority or Other|||||||0.113|||||||ANCOVA on ranks||||
1749519|NCT00360334|3214287|Superiority or Other||Odds Ratio (OR)|0.797||||0.716||95.0|0.235|2.705|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome|
1749520|NCT00360334|3214288|Superiority or Other||Odds Ratio (OR)|0.317||||0.001||95.0|0.159|0.63|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome|
1749521|NCT00360334|3214289|Superiority or Other||Odds Ratio (OR)|0.675||||0.139||95.0|0.401|1.136|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome|
1749522|NCT00360334|3214290|Superiority or Other|||||||0.667|||||||ANCOVA||||
1749523|NCT00360334|3214291|Superiority or Other|||||||0.017|||||||ANCOVA||||
1749530|NCT00360334|3214299|Superiority or Other||Odds Ratio (OR)|27.91||||0.001||95.0|3.7|210.54|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome|
1749531|NCT00360334|3214300|Superiority or Other||||||<|0.001|||||||Mixed Models Repeated Measures||||
1749532|NCT00360334|3214301|Superiority or Other||||||<|0.001|||||||Mixed Model Repeated Measures||||
1749533|NCT00360334|3214302|Superiority or Other||||||<|0.001|||||||Mixed Model Repeated Measures||||
1749534|NCT00360334|3214303|Superiority or Other||||||<|0.001|||||||Mixed Model Repeated Measures||||
1749535|NCT00360334|3214304|Superiority or Other||||||<|0.001|||||||Mixed Model Repeated Measures||||
1749536|NCT00360334|3214306|Superiority or Other||Odds Ratio (OR)|1.43||||0.363||95.0|0.66|3.07|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome|
1749537|NCT00360334|3214307|Superiority or Other||Odds Ratio (OR)|0.7||||0.191||95.0|0.42|1.19|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome|
1749538|NCT00360334|3214308|Superiority or Other||Odds Ratio (OR)|0.75||||0.28||95.0|0.44|1.26|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome|
1749539|NCT00360334|3214309|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1749540|NCT00360334|3214310|Superiority or Other||Odds Ratio (OR)|5.76|||<|0.001||95.0|3.11|10.64|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the secondary outcome divided by the odds of a patient in the insulin glargine arm achieving the secondary outcome|
1749541|NCT00360334|3214311|Superiority or Other||Odds Ratio (OR)|4.71|||<|0.001||95.0|2.62|8.46|||Regression, Logistic|||Odds Ratio (OR) = odds of a patient in the exenatide arm achieving the primary outcome divided by the odds of a patient in the insulin glargine arm achieving the primary outcome|
1749542|NCT00360282|3214316|Superiority or Other|||||||0.549|||||||Sign test||||
1749543|NCT00360282|3214317|Superiority or Other|||||||0.007|||||||Sign test||||
1749544|NCT00359788|3214369|Superiority or Other||Mean Difference (Final Values)|0.285||||0.0085||95.0|0.073|0.496|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749545|NCT00359788|3214370|Superiority or Other||Mean Difference (Final Values)|0.151||||0.163||95.0|-0.061|0.363|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749546|NCT00359788|3214371|Superiority or Other||Mean Difference (Final Values)|0.251||||0.0765||95.0|-0.027|0.528|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749547|NCT00359788|3214372|Superiority or Other||Mean Difference (Final Values)|0.204||||0.0754||95.0|-0.021|0.429|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749548|NCT00359788|3214373|Superiority or Other||Mean Difference (Final Values)|4.204||||0.4929||95.0|-7.857|16.264|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749549|NCT00359788|3214374|Superiority or Other||Mean Difference (Final Values)|1.185||||0.8288||95.0|-9.595|11.964|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749550|NCT00359788|3214375|Superiority or Other||Mean Difference (Final Values)|4.14||||0.4388||95.0|-6.372|14.651|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749551|NCT00359788|3214376|Superiority or Other||Mean Difference (Final Values)|4.062||||0.452||95.0|-6.558|14.683|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749552|NCT00359788|3214377|Superiority or Other||Mean Difference (Final Values)|5.129||||0.3252||95.0|-5.117|15.376|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749553|NCT00359788|3214378|Superiority or Other||Mean Difference (Final Values)|0.194||||0.9696||95.0|-9.811|10.199|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749554|NCT00359788|3214379|Superiority or Other||Mean Difference (Final Values)|-0.971||||0.845||95.0|-10.74|8.799|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749555|NCT00359788|3214380|Superiority or Other||Mean Difference (Final Values)|3.419||||0.4339||95.0|-5.17|12.007|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749556|NCT00359788|3214381|Superiority or Other||Mean Difference (Final Values)|6.898||||0.0935||95.0|-1.172|14.968|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749557|NCT00359788|3214382|Superiority or Other||Mean Difference (Final Values)|2.71||||0.4896||95.0|-5.001|10.421|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749558|NCT00359788|3214383|Superiority or Other||Mean Difference (Final Values)|0.842||||0.8249||95.0|-6.642|8.326|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749559|NCT00359788|3214384|Superiority or Other||Mean Difference (Final Values)|-1.755||||0.6105||95.0|-8.532|5.022|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749560|NCT00359788|3214385|Superiority or Other||Mean Difference (Final Values)|14.074||||0.0153||95.0|2.726|25.422|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749561|NCT00359788|3214386|Superiority or Other||Mean Difference (Final Values)|11.001||||0.0325||95.0|0.924|21.079|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749562|NCT00359788|3214387|Superiority or Other||Mean Difference (Final Values)|11.597||||0.0248||95.0|1.483|21.71|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749873|NCT00356135|3214991|Superiority or Other||||||<|0.0005||||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient||||
1749563|NCT00359788|3214388|Superiority or Other||Mean Difference (Final Values)|14.231||||0.0058||95.0|4.153|24.31|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749564|NCT00359788|3214389|Superiority or Other||Mean Difference (Final Values)|13.655||||0.0048||95.0|4.207|23.104|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749565|NCT00359788|3214390|Superiority or Other||Mean Difference (Final Values)|11.057||||0.0219||95.0|1.613|20.501|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749566|NCT00359788|3214391|Superiority or Other||Mean Difference (Final Values)|11.107||||0.0159||95.0|2.095|20.119|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749567|NCT00359788|3214392|Superiority or Other||Mean Difference (Final Values)|12.052||||0.005||95.0|3.676|20.428|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749568|NCT00359788|3214393|Superiority or Other||Mean Difference (Final Values)|13.568||||0.0013||95.0|5.342|21.795|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749569|NCT00359788|3214394|Superiority or Other||Mean Difference (Final Values)|12.772||||0.0015||95.0|4.942|20.602|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749570|NCT00359788|3214395|Superiority or Other||Mean Difference (Final Values)|11.257||||0.0023||95.0|4.055|18.458|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749571|NCT00359788|3214396|Superiority or Other||Mean Difference (Final Values)|10.698||||0.0004||95.0|4.836|16.56|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749572|NCT00359788|3214397|Superiority or Other||Mean Difference (Final Values)|0.108||||0.7458||95.0|-0.549|0.766|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749573|NCT00359788|3214398|Superiority or Other||Mean Difference (Final Values)|0.317||||0.2911||95.0|-0.273|0.907|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749574|NCT00359788|3214399|Superiority or Other||Mean Difference (Final Values)|0.291||||0.3091||95.0|-0.271|0.852|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749575|NCT00359788|3214400|Superiority or Other||Mean Difference (Final Values)|0.247||||0.3943||95.0|-0.323|0.818|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749576|NCT00359788|3214401|Superiority or Other||Mean Difference (Final Values)|0.121||||0.6765||95.0|-0.449|0.69|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749577|NCT00359788|3214402|Superiority or Other||Mean Difference (Final Values)|0.159||||0.5725||95.0|-0.395|0.714|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749578|NCT00359788|3214403|Superiority or Other||Mean Difference (Final Values)|0.372||||0.1777||95.0|-0.17|0.913|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749579|NCT00359788|3214404|Superiority or Other||Mean Difference (Final Values)|0.363||||0.1805||95.0|-0.169|0.895|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749580|NCT00359788|3214405|Superiority or Other||Mean Difference (Final Values)|0.363||||0.1777||95.0|-0.166|0.893|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749581|NCT00359788|3214406|Superiority or Other||Mean Difference (Final Values)|0.351||||0.182||95.0|-0.165|0.867|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749582|NCT00359788|3214407|Superiority or Other||Mean Difference (Final Values)|0.265||||0.3192||95.0|-0.258|0.788|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749583|NCT00359788|3214408|Superiority or Other||Mean Difference (Final Values)|0.527||||0.1471||95.0|-0.186|1.24|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749584|NCT00359788|3214409|Superiority or Other||Mean Difference (Final Values)|-0.047||||0.8109||95.0|-0.437|0.342|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749585|NCT00359788|3214410|Superiority or Other||Mean Difference (Final Values)|-0.093||||0.6049||95.0|-0.446|0.26|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749586|NCT00359788|3214411|Superiority or Other||Mean Difference (Final Values)|-0.043||||0.7947||95.0|-0.367|0.282|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749587|NCT00359788|3214412|Superiority or Other||Mean Difference (Final Values)|-0.061||||0.7195||95.0|-0.395|0.273|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749588|NCT00359788|3214413|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.3137||95.0|-0.503|0.162|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749589|NCT00359788|3214414|Superiority or Other||Mean Difference (Final Values)|-0.085||||0.6048||95.0|-0.408|0.238|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749590|NCT00359788|3214415|Superiority or Other||Mean Difference (Final Values)|-0.145||||0.4145||95.0|-0.495|0.205|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749591|NCT00359788|3214416|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.6538||95.0|-0.376|0.236|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749592|NCT00359788|3214417|Superiority or Other||Mean Difference (Final Values)|-0.112||||0.4582||95.0|-0.408|0.184|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749593|NCT00359788|3214418|Superiority or Other||Mean Difference (Final Values)|-0.073||||0.6197||95.0|-0.36|0.215|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749594|NCT00359788|3214419|Superiority or Other||Mean Difference (Final Values)|-0.069||||0.6189||95.0|-0.343|0.205|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749595|NCT00359788|3214420|Superiority or Other||Mean Difference (Final Values)|-0.042||||0.7196||95.0|-0.275|0.19|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749596|NCT00359788|3214421|Superiority or Other||Mean Difference (Final Values)|0.223||||0.0001||95.0|0.111|0.335|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749597|NCT00359788|3214422|Superiority or Other||Mean Difference (Final Values)|0.125||||0.0269||95.0|0.014|0.236|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749598|NCT00359788|3214423|Superiority or Other||Mean Difference (Final Values)|0.008||||0.8937||95.0|-0.103|0.118|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749599|NCT00359788|3214424|Superiority or Other||Mean Difference (Final Values)|-0.097||||0.0896||95.0|-0.21|0.015|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749600|NCT00359788|3214425|Superiority or Other||Mean Difference (Final Values)|-0.198||||0.0006||95.0|-0.309|-0.086|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749601|NCT00359788|3214426|Superiority or Other||Mean Difference (Final Values)|-0.215|||<|0.0001||95.0|-0.323|-0.108|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749602|NCT00359788|3214427|Superiority or Other||Mean Difference (Final Values)|-0.193||||0.0002||95.0|-0.296|-0.091|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749603|NCT00359788|3214428|Superiority or Other||Mean Difference (Final Values)|0.175||||0.0015||95.0|0.067|0.283|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749604|NCT00359788|3214429|Superiority or Other||Mean Difference (Final Values)|0.275|||<|0.0001||95.0|0.173|0.378|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749605|NCT00359788|3214430|Superiority or Other||Mean Difference (Final Values)|0.163||||0.0032||95.0|0.055|0.27|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749606|NCT00359788|3214431|Superiority or Other||Mean Difference (Final Values)|0.05||||0.3634||95.0|-0.058|0.158|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749607|NCT00359788|3214432|Superiority or Other||Mean Difference (Final Values)|-0.097||||0.044||95.0|-0.219|0.003|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749608|NCT00359788|3214433|Superiority or Other||Mean Difference (Final Values)|-0.1832||||0.012||95.0|-0.293|-0.072|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749609|NCT00359788|3214434|Superiority or Other||Mean Difference (Final Values)|-0.204||||0.0003||95.0|-0.314|-0.095|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749610|NCT00359788|3214435|Superiority or Other||Mean Difference (Final Values)|-0.189||||0.0004||95.0|-0.293|-0.086|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749611|NCT00359788|3214436|Superiority or Other||Mean Difference (Final Values)|0.278|||<|0.0001||95.0|0.178|0.379|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749612|NCT00359788|3214437|Superiority or Other||Mean Difference (Final Values)|0.081||||0.0984||95.0|-0.015|0.177|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749613|NCT00359788|3214438|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.2992||95.0|-0.143|0.044|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749614|NCT00359788|3214439|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.0003||95.0|-0.261|-0.079|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749615|NCT00359788|3214440|Superiority or Other||Mean Difference (Final Values)|-0.285|||<|0.0001||95.0|-0.376|-0.194|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749616|NCT00359788|3214441|Superiority or Other||Mean Difference (Final Values)|-0.357|||<|0.0001||95.0|-0.451|-0.264|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749617|NCT00359788|3214442|Superiority or Other||Mean Difference (Final Values)|-0.356|||<|0.0001||95.0|-0.44|-0.272|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749618|NCT00359788|3214443|Superiority or Other||Mean Difference (Final Values)|-0.37|||<|0.0001||95.0|-0.449|-0.29|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749619|NCT00359788|3214444|Superiority or Other||Mean Difference (Final Values)|0.136|||<|0.0001||95.0|0.082|0.19|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749620|NCT00359788|3214445|Superiority or Other||Mean Difference (Final Values)|0.074||||0.008||95.0|0.019|0.129|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749621|NCT00359788|3214446|Superiority or Other||Mean Difference (Final Values)|0.02||||0.4814||95.0|-0.037|0.078||ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|ANCOVA||||
1749622|NCT00359788|3214447|Superiority or Other||Mean Difference (Final Values)|-0.046||||0.1182||95.0|-0.103|0.012|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749623|NCT00359788|3214448|Superiority or Other||Mean Difference (Final Values)|-0.083||||0.0044||95.0|-0.139|-0.026|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749624|NCT00359788|3214449|Superiority or Other||Mean Difference (Final Values)|-0.087||||0.0019||95.0|-0.142|-0.033|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749625|NCT00359788|3214450|Superiority or Other||Mean Difference (Final Values)|-0.083||||0.0023||95.0|-0.136|-0.03|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749626|NCT00359788|3214451|Superiority or Other||Mean Difference (Final Values)|0.106|||<|0.0001||95.0|0.055|0.157|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749627|NCT00359788|3214452|Superiority or Other||Mean Difference (Final Values)|0.162|||<|0.0001||95.0|0.108|0.216|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749628|NCT00359788|3214453|Superiority or Other||Mean Difference (Final Values)|0.121|||<|0.0001||95.0|0.066|0.177|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749629|NCT00359788|3214454|Superiority or Other||Mean Difference (Final Values)|0.061||||0.0372||95.0|0.004|0.118|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749630|NCT00359788|3214455|Superiority or Other||Mean Difference (Final Values)|0.018||||0.5387||95.0|-0.076|0.04|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749631|NCT00359788|3214456|Superiority or Other||Mean Difference (Final Values)|-0.062||||0.041||95.0|-0.121|-0.003|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749632|NCT00359788|3214457|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.0354||95.0|-0.116|-0.004|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749633|NCT00359788|3214458|Superiority or Other||Mean Difference (Final Values)|-0.055||||0.0411||95.0|-0.108|-0.002|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749634|NCT00359788|3214459|Superiority or Other||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.098|0.193|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749635|NCT00359788|3214460|Superiority or Other||Mean Difference (Final Values)|0.037||||0.101||95.0|-0.007|0.08|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749636|NCT00359788|3214461|Superiority or Other||Mean Difference (Final Values)|-0.035||||0.0997||95.0|-0.076|0.007|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749637|NCT00359788|3214462|Superiority or Other||Mean Difference (Final Values)|-0.084|||<|0.0001||95.0|-0.125|-0.044|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749638|NCT00359788|3214463|Superiority or Other||Mean Difference (Final Values)|-0.136|||<|0.0001||95.0|-0.175|-0.097|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749639|NCT00359788|3214464|Superiority or Other||Mean Difference (Final Values)|-0.182|||<|0.0001||95.0|-0.221|-0.143|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749640|NCT00359788|3214465|Superiority or Other||Mean Difference (Final Values)|-0.168|||<|0.0001||95.0|-0.205|-0.131|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749641|NCT00359788|3214466|Superiority or Other||Mean Difference (Final Values)|-0.175|||<|0.0001||95.0|-0.207|-0.142|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749642|NCT00359788|3214467|Superiority or Other||Mean Difference (Final Values)|-0.286|||<|0.0001||95.0|-0.375|-0.196|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749643|NCT00359788|3214468|Superiority or Other||Mean Difference (Final Values)|-0.361|||<|0.0001||95.0|-0.449|-0.274|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749644|NCT00359788|3214469|Superiority or Other||Mean Difference (Final Values)|-0.282||||0.0001||95.0|-0.374|-0.191|||ANCOVA||||
1749645|NCT00359788|3214470|Superiority or Other||Mean Difference (Final Values)|0.039||||0.4386||95.0|-0.059|0.137|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749646|NCT00359788|3214471|Superiority or Other||Mean Difference (Final Values)|-0.157|||<|0.0001||95.0|-0.236|-0.078|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749647|NCT00359788|3214472|Superiority or Other||Mean Difference (Final Values)|0.278|||<|0.0001||95.0|0.178|0.379|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749648|NCT00359788|3214473|Superiority or Other||Mean Difference (Final Values)|0.011||||0.835||95.0|-0.092|0.114|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749649|NCT00359788|3214474|Superiority or Other||Mean Difference (Final Values)|0.175||||0.0015||95.0|0.067|0.283|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749650|NCT00359788|3214475|Superiority or Other||Mean Difference (Final Values)|-0.133|||<|0.0001||95.0|-0.175|-0.091|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749651|NCT00359788|3214476|Superiority or Other||Mean Difference (Final Values)|-0.152|||<|0.0001||95.0|-0.19|-0.113|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749652|NCT00359788|3214477|Superiority or Other||Mean Difference (Final Values)|-0.131|||<|0.0001||95.0|-0.171|-0.092|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749653|NCT00359788|3214478|Superiority or Other||Mean Difference (Final Values)|0.054||||0.0447||95.0|0.001|0.106|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749654|NCT00359788|3214479|Superiority or Other||Mean Difference (Final Values)|-0.08|||<|0.0001||95.0|-0.114|-0.046|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749655|NCT00359788|3214480|Superiority or Other||Mean Difference (Final Values)|0.145|||<|0.0001||95.0|0.098|0.193|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749656|NCT00359788|3214481|Non-Inferiority or Equivalence|Non-inferiority margin = 0.05 liters|Mean Difference (Final Values)|0.02||||0.0042||95.0|-0.032|0.072|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749657|NCT00359788|3214482|Superiority or Other||Mean Difference (Final Values)|0.106|||<|0.0001|2-Sided|95.0|0.055|0.157|||ANCOVA|ANCOVA model with terms for treatment and center as fixed effects and baseline as a covariate.|||
1749774|NCT00358449|3214636|Superiority or Other||Mean Difference (Final Values)|0.088||||0.572|2-Sided|95.0|-0.224|0.4|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749658|NCT00359762|3214485|Superiority or Other||Least Squares Mean Difference|0.28|Standard Error of the Mean|0.141||0.0508|2-Sided|95.0|0.0|0.55|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value at Period III as a covariate. The compound symmetric covariance structure was assumed.|
1749659|NCT00359762|3214486|Superiority or Other||Least Squares Mean Difference|0.29|Standard Error of the Mean|0.037|<|0.0001|2-Sided|95.0|0.22|0.37|||Negative Binomial Model|||The number of hypoglycemic episodes by patient were compared between treatment groups using a negative binomial model with effects for treatment and baseline HbA1c and the logarithm of the days of exposure as the offset variable.|
1749660|NCT00359762|3214487|Superiority or Other||Least Squares Mean Difference|0.06|Standard Error of the Mean|0.019||0.0011|2-Sided|95.0|0.02|0.1|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.|
1749661|NCT00359762|3214488|Superiority or Other||Least Squares Mean Difference|0.02|Standard Error of the Mean|0.079||0.7914|2-Sided|95.0|-0.13|0.18|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.|
1749662|NCT00359762|3214489|Superiority or Other||Least Squares Mean Difference|-0.26|Standard Error of the Mean|0.089||0.0042|2-Sided|95.0|-0.43|-0.08|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.|
1749663|NCT00359762|3214490|Superiority or Other||Least Squares Mean Difference|-0.72|Standard Error of the Mean|0.805||0.3737|2-Sided|95.0|-2.3|0.86|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and visit by treatment interaction, and baseline value as a covariate. The unstructured covariance matrix was used.|
1749664|NCT00359762|3214491|Superiority or Other||Least Squares Mean Difference|-1.71|Standard Error of the Mean|0.75||0.0228|2-Sided|95.0|-3.18|-0.24|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.|
1749665|NCT00359762|3214492|Superiority or Other||Least Squares Mean Difference|-5.2|Standard Error of the Mean|1.228|<|0.0001|2-Sided|95.0|-7.61|-2.79|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.|
1749666|NCT00359762|3214493|Superiority or Other||Least Squares Mean Difference|-5.4|Standard Error of the Mean|0.463|<|0.0001|2-Sided|95.0|-6.31|-4.49|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction and baseline value as a covariate. The unstructured covariance matrix was used.|
1749667|NCT00359762|3214494|Superiority or Other||Least Squares Mean Difference|-2.19|Standard Error of the Mean|0.327|<|0.0001|2-Sided|95.0|-2.84|-1.55|||ANCOVA|||Change in postprandial (2 hours) plasma glucose from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (<=7.3%, >7.3% to <=8.2%, >8.2%) as factors and baseline value as a covariate.|
1749668|NCT00359762|3214495|Superiority or Other||Least Squares Mean Difference|-2.8|Standard Error of the Mean|0.424|<|0.0001|2-Sided|95.0|-3.64|-1.97|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.|
1749669|NCT00359762|3214496|Superiority or Other||Least Squares Mean Difference|-0.47|Standard Error of the Mean|0.183||0.0109|2-Sided|95.0|-0.83|-0.11|||ANCOVA|||Change in fasting plasma glucose from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (<=7.3%, >7.3% to <=8.2%, >8.2%) as factors and baseline value as a covariate.|
1749670|NCT00359762|3214497|Superiority or Other||Least Squares Mean Difference|-0.69|Standard Error of the Mean|0.174|<|0.0001|2-Sided|95.0|-1.03|-0.34|||Mixed Models Analysis|||MMRM includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.|
1749671|NCT00359762|3214498|Superiority or Other||Least Squares Mean Difference|-0.16|Standard Error of the Mean|0.05||0.0015|2-Sided|95.0|-0.26|-0.06|||ANCOVA|||Change in HbA1c from baseline to endpoint was analyzed by an ANCOVA model that includes treatment as factor and baseline value as a covariate.|
1749672|NCT00359762|3214499|Superiority or Other||Least Squares Mean Difference|-0.18|Standard Error of the Mean|0.07||0.0128|2-Sided|95.0|-0.31|-0.04|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.|
1749673|NCT00359762|3214500|Superiority or Other||Least Squares Mean Difference|7.33|Standard Error of the Mean|2.128||0.0006|2-Sided|95.0|3.15|11.5|||ANCOVA|||Change in disposition index from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (<=7.3%, >7.3% to <=8.2%, >8.2%) as factors and baseline value as a covariate.|
1749674|NCT00359762|3214501|Superiority or Other||Least Squares Mean Difference|4.67|Standard Error of the Mean|1.598||0.0036|2-Sided|95.0|1.53|7.81|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.|
1749675|NCT00359762|3214502|Superiority or Other||Least Squares Mean Difference|11.19|Standard Error of the Mean|4.966||0.0246|2-Sided|95.0|1.44|20.95|||ANCOVA|||Change in DI30/DG30 ratio from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (<=7.3%, >7.3% to <=8.2%, >8.2%) as factors and baseline value as a covariate.|
1749676|NCT00359762|3214503|Superiority or Other||Least Squares Mean Difference|-0.56|Standard Error of the Mean|4.497||0.9001|2-Sided|95.0|-9.4|8.27|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.|
1749677|NCT00359762|3214504|Superiority or Other||Least Squares Mean Difference|-0.02|Standard Error of the Mean|0.017||0.25|2-Sided|95.0|-0.05|0.01|||ANCOVA|||Change in fasting proinsulin/insulin ratio from baseline to endpoint was analyzed by an ANCOVA model that includes treatment and baseline HbA1c stratum (<=7.3%, >7.3% to <=8.2%, >8.2%) as factors and baseline value as a covariate.|
1749735|NCT00358449|3214627|Superiority or Other||Mean Difference (Final Values)|5.49||||0.672|2-Sided|95.0|-20.87|31.86|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749678|NCT00359762|3214505|Superiority or Other||Least Squares Mean Difference|0.0|Standard Error of the Mean|0.032||0.904|2-Sided|95.0|-0.07|0.06|||Mixed Models Analysis|||MMRM analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.|
1749679|NCT00359762|3214506|Superiority or Other||Least Squares Mean Difference|-14.35|Standard Error of the Mean|7.399||0.0528|2-Sided|95.0|-28.88|0.17|||ANCOVA|||Change in HOMA-B from baseline to endpoint was analyzed by an analysis of covariance (ANCOVA) model that includes treatment and baseline HbA1c stratum (<=7.3%, >7.3% to <=8.2%, >8.2%) as factors and baseline value as a covariate.|
1749680|NCT00359762|3214507|Superiority or Other||Least Squares Mean Difference|-1.66|Standard Error of the Mean|5.56||0.7648|2-Sided|95.0|-12.58|9.25|||Mixed Models Analysis|||Mixed-model Repeated Measures (MMRM) analysis includes treatment, visit, and treatment by visit interaction, and baseline value as a covariate. The unstructured covariance matrix was used.|
1749681|NCT00359762|3214508|Superiority or Other|||||||0.0315|||||||Log Rank|||Kaplan-Meier survival curves for time to treatment failure were compared between treatment groups using log rank test.|
1749682|NCT00359762|3214509|Non-Inferiority or Equivalence|Non inferiority test was based on the upper 1-sided 97.5% CI for the hazard ratio of Exenatide/Glimepiride;the upper bound was compared to 1.25: if <1.25, the hypothesis that the risk of treatment failure with Exenatide is more than 1.25 times greater than the risk with Glimepiride is rejected.Superiority test was based on the 2-sided 95% CI for the hazard ratio. If CI excludes 1, the hypothesis that the risk of treatment failure with Exenatide is equal to that with Glimepiride is rejected.|Hazard Ratio|0.748||||0.002|2-Sided|95.0|0.623|0.899|||Regression, Cox|Time to treatment failure was modeled using Cox regression with treatment and baseline HbA1c as predictive terms.||The null hypothesis (H0) and alternative hypothesis (H1) for the primary analysis (i.e., non-inferiority) are:H0: hazards of treatment for Exenatide/hazards of treatment for Glimepiride >=1.25.H1: hazards of treatment for Exenatide/hazards of treatment for Glimepiride < 1.25. With 527 patients in each arm, the study would have approximately 90% power to conclude non-inferiority of Exenatide to Glimepiride.|
1749683|NCT00359424|3214541|Superiority or Other||Risk Difference (RD)|0.4||||0.8275|2-Sided|99.0|-4.6|5.5||The CMH statistic is tested at the two-sided alpha level of 0.01.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with sICH within 30 hours post IV tPA initiation in IV Only and Endovascular treatment arms).|
1749684|NCT00359424|3214542|Superiority or Other||Risk Difference (RD)|-2.0||||0.5241|2-Sided|99.0|-10.3|6.2||The CMH statistic is tested at the two-sided alpha level of 0.01.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mortality within 90 days post-randomization in IV Only and Endovascular treatment arms).|
1749685|NCT00359424|3214543|Superiority or Other||Risk Difference (RD)|1.5||||0.7031|2-Sided|95.0|-6.1|9.1||The CMH statistic is tested at the two-sided alpha level of 0.05. For the interim analyses of the primary efficacy analysis, the alpha spending function method (Lan and DeMets, 1987) with O'Brien and Fleming (1979) stopping boundaries were adopted.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test adjusting for the dichotomized baseline NIHSS score (<20 or ≥20).|Positive adjusted risk difference indicates greater risk in the Endovascular group, while negative adjusted risk difference indicates greater risk in the IV Only group.|Test of null hypothesis (equal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms) versus alternative hypothesis (unequal proportions of subjects with mRS of 0-2 at 90 days post-randomization in IV Only and Endovascular treatment arms).|
1749686|NCT00359216|3214555|Superiority or Other|||||||0.9219|||||||ANCOVA|||The p-value is obtained by F-test in ANCOVA to assess the treatment group difference in changes from baseline, adjusted for baseline.|
1749687|NCT00359203|3214556|Non-Inferiority or Equivalence|The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the treatment arm applying a log-rank test with a 2-sided significance level of 0.05.|Hazard Ratio (HR)|0.43||||0.039|2-Sided|95.0|0.19|0.96||For the final analysis the threshold of statistical significance was set at 0.04.|Log Rank||Numerator=pacemaker ON denominator=pacemaker OFF||
1749688|NCT00359203|3214556|Superiority or Other||Hazard Ratio (HR)|0.43||||0.04|2-Sided|95.0|0.19|0.96|||Log Rank|The risk of syncope recurrence was based on HR obtained by means of the univarate Cox model, with the use of the Breslow method for ties.|numerator=pacemaker ON denominator=pacemaker OFF|The analysis was designed to have 80% power to detect a 1-year absolute reduction of 25% in the risk of recurrence of first syncope in the Pm ON arm applying a log-rank test with a 2-sided significance level of 0.05. This analysis was planned as a comparison of the cumulative risk of syncope between the 2 groups with the use of a log-rank test.|
1749689|NCT00358917|3214571|Superiority or Other|||||||0.222|||||||Fisher Exact||||
1749690|NCT00358917|3214573|Superiority or Other|||||||0.281|||||||ANOVA||||
1749691|NCT00358917|3214574|Superiority or Other||Diff. in Percentage of Subj. Responding|3.8||||0.389||95.0|-4.3|11.9|||normal approx. to binomial distribution||||
1749736|NCT00358449|3214627|Superiority or Other||Mean Difference (Final Values)|10.57||||0.381|2-Sided|95.0|-13.81|34.94|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749737|NCT00358449|3214627|Superiority or Other||Mean Difference (Final Values)|4.12||||0.664|2-Sided|95.0|-15.11|23.36|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749738|NCT00358449|3214627|Superiority or Other||Mean Difference (Final Values)|9.45||||0.27|2-Sided|95.0|-7.77|26.67|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749868|NCT00356135|3214991|Superiority or Other|||||||0.0018||||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient||||
1749692|NCT00358917|3214575|Non-Inferiority or Equivalence|The 95% confidence interval for the difference in response rates (once daily [QD] minus twice daily [BID], based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|Diff. in Percentage of Subj. Responding|3.5||||0.413||95.0|-4.5|11.5|||normal approx. to binomial distribution|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 participants (300 participants in each of the QD and BID treatment regimens) provided 83% power (with a type I error rate of 0.05) to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.|
1749693|NCT00358826|3214576|Superiority or Other|||||||0.99||||||Dunnett test compared with Placebo|ANCOVA||||
1749694|NCT00358826|3214576|Superiority or Other|||||||0.11||||||Dunnett test compared with Placebo|ANCOVA||||
1749695|NCT00358826|3214576|Superiority or Other|||||||0.99||||||Dunnett test compared with Placebo|ANCOVA||||
1749696|NCT00358826|3214577|Superiority or Other|||||||1||||||Dunnett test compared with Placebo|ANCOVA||||
1749697|NCT00358826|3214577|Superiority or Other|||||||0.96||||||Dunnett test compared with Placebo|ANCOVA||||
1749698|NCT00358826|3214577|Superiority or Other|||||||0.92||||||Dunnett test compared with Placebo|ANCOVA||||
1749699|NCT00358826|3214578|Superiority or Other|||||||0.6||||||Dunnett test compared with Placebo|ANCOVA||||
1749700|NCT00358826|3214578|Superiority or Other||||||<|0.005||||||Dunnett test compared with Placebo|ANCOVA||||
1749701|NCT00358826|3214578|Superiority or Other||||||<|0.22||||||Dunnett test compared with Placebo|ANCOVA||||
1749702|NCT00358826|3214579|Superiority or Other||||||<|0.001||||||Adjusted using Dunnett's method.|ANOVA||||
1749703|NCT00358826|3214579|Superiority or Other||||||<|0.606||||||Adjusted using Dunnett's method.|ANCOVA||||
1749704|NCT00358826|3214579|Superiority or Other||||||<|0.331||||||Adjusted using Dunnett's method.|ANCOVA||||
1749705|NCT00358826|3214580|Superiority or Other|||||||0.996||||||Adjusted using Dunnett's method.|ANCOVA||||
1749706|NCT00358826|3214580|Superiority or Other|||||||0.863||||||Adjusted using Dunnett's method.|ANCOVA||||
1749707|NCT00358826|3214580|Superiority or Other|||||||0.656||||||Adjusted using Dunnett's method.|ANCOVA||||
1749708|NCT00358826|3214581|Superiority or Other||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.|||
1749709|NCT00358826|3214581|Superiority or Other||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.|||
1749710|NCT00358826|3214581|Superiority or Other||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.|||
1749711|NCT00358826|3214582|Superiority or Other||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.|||
1749712|NCT00358826|3214582|Superiority or Other||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.|||
1749713|NCT00358826|3214582|Superiority or Other||||||<|0.001||||||Adjusted using Dunnett's method.|ANCOVA|The model included treatment effect, with baseline value as a covariate.|||
1749714|NCT00358735|3214585|Superiority or Other|||||||0.036|||||||Chi-squared||||
1749715|NCT00358735|3214586|Superiority or Other|||||||0.798|||||||Chi-squared||||
1749716|NCT00358735|3214587|Superiority or Other|||||||0.052|||||||Chi-squared||||
1749717|NCT00358735|3214588|Superiority or Other|||||||0.507|||||||Chi-squared||||
1749718|NCT00358735|3214589|Superiority or Other|||||||0.01|||||||Chi-squared||||
1749719|NCT00358735|3214590|Superiority or Other|||||||0.05|||||||Chi-squared||||
1749720|NCT00358735|3214591|Superiority or Other|||||||0.953|||||||Chi-squared||||
1749721|NCT00358735|3214593|Superiority or Other|||||||0.0004|||||||Chi-squared||||
1749722|NCT00358735|3214594|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1749723|NCT00358735|3214595|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1749724|NCT00358644|3214601|Superiority or Other||Percentage of Participants|23.6||||||95.0|13.2|37.0|||||||
1749725|NCT00358449|3214624|Superiority or Other||Mean Difference (Final Values)|-17.79||||0.071|2-Sided|95.0|-35.21|-0.38|||Van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline at week 24||
1749726|NCT00358449|3214624|Superiority or Other||Mean Difference (Final Values)|-9.25||||0.525|2-Sided|95.0|-29.69|11.2|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 24||
1749727|NCT00358449|3214624|Superiority or Other||Mean Difference (Final Values)|-6.7||||0.352|2-Sided|95.0|-24.41|11.01|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 12||
1749728|NCT00358449|3214624|Superiority or Other||Mean Difference (Final Values)|-2.63||||0.747|2-Sided|95.0|-20.68|15.41|||van Elteren test||P-value, 95% CI, and Estimated value are presented for change from baseline values at Week 12||
1749729|NCT00358449|3214625|Superiority or Other||Mean Difference (Final Values)|-33.8||||0.105|2-Sided|95.0|-79.2|11.6|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 24||
1749730|NCT00358449|3214625|Superiority or Other||Mean Difference (Final Values)|-15.3||||0.92|2-Sided|95.0|-76.3|45.7|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 24||
1749731|NCT00358449|3214625|Superiority or Other||Mean Difference (Final Values)|-2.1||||0.633|2-Sided|95.0|-44.6|40.5|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 12||
1749732|NCT00358449|3214625|Superiority or Other||Mean Difference (Final Values)|-18.3||||0.421|2-Sided|95.0|-71.1|34.4|||van Elteren test||P-value, 95% CI, and Estimated value are presented for Change from Baseline at Week 12||
1749733|NCT00358449|3214626|Superiority or Other|||||||0.111|||||||Cochran-Mantel-Haenszel||||
1749734|NCT00358449|3214626|Superiority or Other|||||||0.4|||||||Cochran-Mantel-Haenszel||||
1749739|NCT00358449|3214628|Superiority or Other||Mean Difference (Final Values)|0.25||||0.564|2-Sided|95.0|-0.631|1.132|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749740|NCT00358449|3214628|Superiority or Other||Mean Difference (Final Values)|0.71||||0.082|2-Sided|95.0|-0.096|1.516|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749741|NCT00358449|3214628|Superiority or Other||Mean Difference (Final Values)|0.241||||0.425|2-Sided|95.0|-0.369|0.852|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749742|NCT00358449|3214628|Superiority or Other||Mean Difference (Final Values)|0.513||||0.062|2-Sided|95.0|-0.028|1.055|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749743|NCT00358449|3214629|Superiority or Other||Mean Difference (Final Values)|-0.45||||0.895|2-Sided|95.0|-7.34|6.44|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749744|NCT00358449|3214629|Superiority or Other||Mean Difference (Final Values)|-1.6||||0.595|2-Sided|95.0|-7.68|4.47|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749745|NCT00358449|3214629|Superiority or Other||Mean Difference (Final Values)|-0.59||||0.882|2-Sided|95.0|-8.55|7.38|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749746|NCT00358449|3214629|Superiority or Other||Mean Difference (Final Values)|-1.79||||0.609|2-Sided|95.0|-8.79|5.22|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749747|NCT00358449|3214630|Superiority or Other||Mean Difference (Final Values)|0.128||||0.7|2-Sided|95.0|-0.541|0.798|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749748|NCT00358449|3214630|Superiority or Other||Mean Difference (Final Values)|0.29||||0.345|2-Sided|95.0|-0.326|0.906|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749749|NCT00358449|3214630|Superiority or Other||Mean Difference (Final Values)|0.356||||0.12|2-Sided|95.0|-0.097|0.809|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749750|NCT00358449|3214630|Superiority or Other||Mean Difference (Final Values)|0.37||||0.077|2-Sided|95.0|-0.042|0.782|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749751|NCT00358449|3214631|Superiority or Other||Mean Difference (Final Values)|0.121||||0.649|2-Sided|95.0|-0.417|0.66|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749752|NCT00358449|3214631|Superiority or Other||Mean Difference (Final Values)|0.182||||0.465|2-Sided|95.0|-0.319|0.683|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749753|NCT00358449|3214631|Superiority or Other||Mean Difference (Final Values)|0.354||||0.115|2-Sided|95.0|-0.09|0.798|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749754|NCT00358449|3214631|Superiority or Other||Mean Difference (Final Values)|0.3||||0.142|2-Sided|95.0|-0.105|0.704|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749755|NCT00358449|3214632|Superiority or Other||Mean Difference (Final Values)|-1.01||||0.691|2-Sided|95.0|-6.11|4.09|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749756|NCT00358449|3214632|Superiority or Other||Mean Difference (Final Values)|-1.05||||0.657|2-Sided|95.0|-5.82|3.72|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749757|NCT00358449|3214632|Superiority or Other||Mean Difference (Final Values)|0.9||||0.496|2-Sided|95.0|-1.74|3.54|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749758|NCT00358449|3214632|Superiority or Other||Mean Difference (Final Values)|-0.85||||0.515|2-Sided|95.0|-3.45|1.76|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749759|NCT00358449|3214633|Superiority or Other||Mean Difference (Final Values)|0.076||||0.832|2-Sided|95.0|-0.643|0.794|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749760|NCT00358449|3214633|Superiority or Other||Mean Difference (Final Values)|0.187||||0.568|2-Sided|95.0|-0.474|0.849|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749761|NCT00358449|3214633|Superiority or Other||Mean Difference (Final Values)|-0.161||||0.5|2-Sided|95.0|-0.639|0.317|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749762|NCT00358449|3214633|Superiority or Other||Mean Difference (Final Values)|0.09||||0.691|2-Sided|95.0|-0.365|0.545|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749763|NCT00358449|3214634|Superiority or Other||Mean Difference (Final Values)|0.068||||0.716|2-Sided|95.0|-0.308|0.443|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749764|NCT00358449|3214634|Superiority or Other||Mean Difference (Final Values)|0.089||||0.607|2-Sided|95.0|-0.259|0.436|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749765|NCT00358449|3214634|Superiority or Other||Mean Difference (Final Values)|-0.159||||0.235|2-Sided|95.0|-0.426|0.108|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749766|NCT00358449|3214634|Superiority or Other||Mean Difference (Final Values)|0.038||||0.762|2-Sided|95.0|-0.217|0.294|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749767|NCT00358449|3214635|Superiority or Other||Mean Difference (Final Values)|-0.51||||0.898|2-Sided|95.0|-8.61|7.58|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749768|NCT00358449|3214635|Superiority or Other||Mean Difference (Final Values)|-4.6||||0.215|2-Sided|95.0|-12.0|2.81|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749769|NCT00358449|3214635|Superiority or Other||Mean Difference (Final Values)|-2.16||||0.45|2-Sided|95.0|-7.87|3.56|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749770|NCT00358449|3214635|Superiority or Other||Mean Difference (Final Values)|-1.13||||0.666|2-Sided|95.0|-6.39|4.12|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749771|NCT00358449|3214636|Superiority or Other||Mean Difference (Final Values)|0.105||||0.317|2-Sided|95.0|-0.105|0.315|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749772|NCT00358449|3214636|Superiority or Other||Mean Difference (Final Values)|0.005||||0.96|2-Sided|95.0|-0.188|0.197|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749773|NCT00358449|3214636|Superiority or Other||Mean Difference (Final Values)|-0.012||||0.942|2-Sided|95.0|-0.35|0.326|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749775|NCT00358449|3214637|Superiority or Other||Mean Difference (Final Values)|-5.42||||0.666|2-Sided|95.0|-30.74|19.9|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749776|NCT00358449|3214637|Superiority or Other||Mean Difference (Final Values)|16.04||||0.141|2-Sided|95.0|-5.61|37.7|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749777|NCT00358449|3214637|Superiority or Other||Mean Difference (Final Values)|5.62||||0.551|2-Sided|95.0|-13.29|24.54|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749778|NCT00358449|3214637|Superiority or Other||Mean Difference (Final Values)|14.06||||0.123|2-Sided|95.0|-4.0|32.13|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749779|NCT00358449|3214638|Superiority or Other||Mean Difference (Final Values)|-0.176||||0.653|2-Sided|95.0|-0.965|0.614|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749780|NCT00358449|3214638|Superiority or Other||Mean Difference (Final Values)|0.353||||0.291|2-Sided|95.0|-0.317|1.023|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749781|NCT00358449|3214638|Superiority or Other||Mean Difference (Final Values)|0.26||||0.371|2-Sided|95.0|-0.32|0.839|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749782|NCT00358449|3214638|Superiority or Other||Mean Difference (Final Values)|0.324||||0.241|2-Sided|95.0|-0.226|0.873|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749783|NCT00358449|3214639|Superiority or Other||Mean Difference (Final Values)|21.11||||0.055|2-Sided|95.0|-0.51|42.74|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749784|NCT00358449|3214639|Superiority or Other||Mean Difference (Final Values)|17.69||||0.078|2-Sided|95.0|-2.1|37.48|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749785|NCT00358449|3214639|Superiority or Other||Mean Difference (Final Values)|14.21||||0.16|2-Sided|95.0|-5.83|34.25|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749786|NCT00358449|3214639|Superiority or Other||Mean Difference (Final Values)|19.28||||0.046|2-Sided|95.0|0.39|38.18|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749787|NCT00358449|3214640|Superiority or Other||Mean Difference (Final Values)|15.1||||0.246|2-Sided|95.0|-10.91|41.11|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749788|NCT00358449|3214640|Superiority or Other||Mean Difference (Final Values)|11.83||||0.317|2-Sided|95.0|-11.86|35.52|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749789|NCT00358449|3214640|Superiority or Other||Mean Difference (Final Values)|3.92||||0.622|2-Sided|95.0|-12.01|19.84|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749790|NCT00358449|3214640|Superiority or Other||Mean Difference (Final Values)|1.59||||0.832|2-Sided|95.0|-13.47|16.65|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749791|NCT00358449|3214641|Superiority or Other||Mean Difference (Final Values)|0.343||||0.219|2-Sided|95.0|-0.214|0.899|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749792|NCT00358449|3214641|Superiority or Other||Mean Difference (Final Values)|0.433||||0.095|2-Sided|95.0|-0.08|0.946|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749793|NCT00358449|3214641|Superiority or Other||Mean Difference (Final Values)|0.371||||0.145||95.0|-0.133|0.874|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749794|NCT00358449|3214641|Superiority or Other||Mean Difference (Final Values)|0.356||||0.139|2-Sided|95.0|-0.121|0.833|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749795|NCT00358449|3214642|Superiority or Other||Mean Difference (Final Values)|0.211||||0.488|2-Sided|95.0|-0.401|0.823|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749796|NCT00358449|3214642|Superiority or Other||Mean Difference (Final Values)|0.334||||0.239|2-Sided|95.0|-0.232|0.901|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 21-24.||
1749797|NCT00358449|3214642|Superiority or Other||Mean Difference (Final Values)|0.12||||0.593||95.0|-0.331|0.572|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749798|NCT00358449|3214642|Superiority or Other||Mean Difference (Final Values)|0.128||||0.551|2-Sided|95.0|-0.303|0.56|||ANCOVA||P-value, 95% CI, and estimated value are presented for Weeks 9-12.||
1749799|NCT00358449|3214645|Superiority or Other||Odds Ratio (OR)|0.21||||0.19|2-Sided|95.0|0.01|2.07|||Regression, Logistic||||
1749800|NCT00358449|3214645|Superiority or Other||Odds Ratio (OR)|0.55||||0.865|2-Sided|95.0|0.04|5.44|||Regression, Logistic||||
1749801|NCT00358215|3214669|Superiority or Other||Least Squares Mean Difference|2.29|Standard Error of the Mean|0.9||0.011|2-Sided|95.0|0.53|4.05|||Mixed Models Analysis|Mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.|||
1749802|NCT00358215|3214670|Superiority or Other||Least Squares Mean Difference|2.2|Standard Error of the Mean|0.79||0.005|2-Sided|95.0|0.65|3.75|||Mixed Models Analysis|Mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.|||
1749803|NCT00358215|3214671|Superiority or Other||Hazard Ratio (HR)|1.01||||0.922|2-Sided|95.0|0.89|1.14||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none).|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.||
1749804|NCT00358215|3214672|Superiority or Other||Hazard Ratio (HR)|1.04||||0.512|2-Sided|95.0|0.92|1.19||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none).|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.||
1749805|NCT00358215|3214673|Superiority or Other||Hazard Ratio (HR)|1.01||||0.871|2-Sided|95.0|0.9|1.13||Stratification factors are: region and type of device (cardiac resynchronization therapy (CRT) with or without implantable cardioverter defibrillator (ICD), ICD without CRT, or none)|Stratified Log Rank||The hazard ratio and 95% confidence intervals are from the Cox proportional hazards model adjusted by the stratification factors.||
1749806|NCT00357994|3214695|Superiority or Other||Treatment Difference (LS Mean)|11.4|Standard Error of the Mean|3.7||0.0033|2-Sided|95.0|4.0|18.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749807|NCT00357994|3214696|Superiority or Other||Treatment Difference (LS Mean)|-1.5|Standard Error of the Mean|2.9||0.6088|2-Sided|95.0|-7.4|4.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749808|NCT00357994|3214697|Superiority or Other||Treatment Difference (LS Mean)|-0.4|Standard Error of the Mean|0.4||0.3578|2-Sided|95.0|-1.1|0.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749809|NCT00357994|3214698|Superiority or Other||Treatment Difference (LS Mean)|-1.2|Standard Error of the Mean|0.6||0.0361|2-Sided|95.0|-2.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749810|NCT00357994|3214699|Superiority or Other||Treatment Difference (LS Mean)|0.3|Standard Error of the Mean|0.3||0.3741|2-Sided|95.0|-0.4|0.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749811|NCT00357994|3214700|Superiority or Other||Treatment Difference (LS Mean)|-3.3|Standard Error of the Mean|5.1||0.5213|2-Sided|95.0|-13.6|6.9|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749812|NCT00357994|3214701|Superiority or Other||Treatment Difference (LS Mean)|-13.8|Standard Error of the Mean|3.5||0.0002|2-Sided|95.0|-20.8|-6.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749813|NCT00357994|3214702|Superiority or Other||Treatment Difference (LS Mean)|-4.0|Standard Error of the Mean|3.4||0.2407|2-Sided|95.0|-10.8|2.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749814|NCT00357994|3214703|Superiority or Other||Treatment Difference (LS Mean)|-3.8|Standard Error of the Mean|3.1||0.2243|2-Sided|95.0|-9.9|2.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749815|NCT00357994|3214704|Superiority or Other||Treatment Difference (LS Mean)|-4.5|Standard Error of the Mean|3.8||0.2423|2-Sided|95.0|-12.0|3.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749816|NCT00357994|3214705|Superiority or Other||Treatment Difference (LS Mean)|-2.2|Standard Error of the Mean|3.4||0.5246|2-Sided|95.0|-9.0|4.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749817|NCT00357994|3214706|Superiority or Other||Treatment Difference (LS Mean)|-11.6|Standard Error of the Mean|4.5||0.0129|2-Sided|95.0|-20.6|-2.5|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749818|NCT00357994|3214707|Superiority or Other||Treatment Difference (LS Mean)|-10.4|Standard Error of the Mean|4.3||0.0184|2-Sided|95.0|-19.1|-1.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749819|NCT00357994|3214708|Superiority or Other||Treatment Difference (LS Mean)|-0.08|Standard Error of the Mean|0.45||0.8574|2-Sided|95.0|-0.98|0.82|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.|||
1749820|NCT00357994|3214709|Superiority or Other||Treament Difference (LS Mean)|-4.5|Standard Error of the Mean|3.1||0.1501|2-Sided|95.0|-10.7|1.7|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1749821|NCT00357994|3214710|Superiority or Other||Treatment Difference (LS Mean)|0.07|Standard Error of the Mean|0.038||0.067|2-Sided|95.0|-0.005|0.146|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding Baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1749822|NCT00357994|3214711|Superiority or Other||Treatment Difference (LS Mean)|1.4|Standard Error of the Mean|2.1||0.502|2-Sided|95.0|-2.8|5.6|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1749823|NCT00357994|3214712|Superiority or Other||Treatment Difference (LS Mean)|-3.0|Standard Error of the Mean|1.1||0.0086|2-Sided|95.0|-5.3|-0.8|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1749824|NCT00357994|3214713|Superiority or Other||Treatment Difference (LS Mean)|-0.7|Standard Error of the Mean|0.3||0.0258|2-Sided|95.0|-1.4|-0.1|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the baseline CGI-S as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1749825|NCT00357994|3214714|Superiority or Other||Treatment Difference (LS Mean)|-7.0|Standard Error of the Mean|2.8||0.0155|2-Sided|95.0|-12.6|-1.4|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1749826|NCT00357994|3214715|Superiority or Other||Treatment Difference (LS Mean)|1.86|Standard Error of the Mean|0.65||0.0059|2-Sided|95.0|0.56|3.17|||ANCOVA|Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline as a covariate.||Since the null hypothesis for the primary analysis was rejected in favor of the alternative hypothesis, hierarchical testing was performed for secondary variables on the Full Analysis data set at the 0.50 level using a gatekeeping procedure to preserve family-wise error rate.|
1749827|NCT00357994|3214716|Superiority or Other||Treatment Difference (LS Mean)|-1.91|Standard Error of the Mean|0.57||0.0015|2-Sided|95.0|-3.05|-0.76||Treatment comparisons are based on an ANCOVA model including effects for treatment, country, and with the corresponding baseline and the natural logarithm of the mean daily dose of rescue medication on valid symptom diary days as covariates.|ANCOVA||||
1749828|NCT00357968|3214717|Superiority or Other||Mean Difference (Net)|-0.04||||0.4528|2-Sided|95.0|-0.25|0.07|||ANCOVA||||
1749829|NCT00357968|3214718|Superiority or Other||Mean Difference (Net)|0.01||||0.7893|2-Sided|95.0|-0.06|0.08|||ANCOVA||||
1749830|NCT00357968|3214719|Superiority or Other||Mean Difference (Net)|-1.33||||0.4029|2-Sided|95.0|-4.48|1.82|||ANCOVA||||
1749831|NCT00357968|3214720|Superiority or Other||Mean Difference (Net)|-0.47||||0.7058|2-Sided|95.0|-2.95|2.0|||ANCOVA||||
1749832|NCT00357968|3214721|Superiority or Other||LS Mean difference|-20.1|||<|0.0001|2-Sided|95.0|-25.7|-14.5|||Mixed Models Analysis||||
1749833|NCT00357968|3214722|Superiority or Other||Mean Difference (Net)|-56.2|||<|0.0001|2-Sided|95.0|-63.2|-49.2|||ANCOVA||||
1749834|NCT00357968|3214723|Superiority or Other||Mean Difference (Net)|-60.5|||<|0.0001|2-Sided|95.0|-67.1|-54.0|||ANCOVA||||
1749835|NCT00357968|3214724|Superiority or Other||Mean Difference (Net)|-54.3|||<|0.0001|2-Sided|95.0|-61.2|-47.4|||ANCOVA||||
1749836|NCT00357968|3214725|Superiority or Other|||||||0.1827|||||||Fisher Exact||||
1749837|NCT00357968|3214726|Superiority or Other|||||||0.0629|||||||Fisher Exact||||
1749838|NCT00357968|3214727|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1749839|NCT00357968|3214732|Superiority or Other||Mean Difference (Net)|44.75|||<|0.0001|2-Sided|95.0|38.35|51.15|||ANCOVA||||
1749840|NCT00357968|3214733|Superiority or Other||LS Mean difference|14.93|||<|0.0001|2-Sided|95.0|10.6|19.26|||Mixed Models Analysis||||
1749841|NCT00357968|3214734|Superiority or Other||Mean Difference (Net)|43.21|||<|0.0001|2-Sided|95.0|38.04|48.38|||ANCOVA||||
1749842|NCT00357903|3214737|Superiority or Other||Standardized incidence rate|1.3||||||95.0|0.97|1.71|||||||
1749843|NCT00357903|3214737|Superiority or Other||Standardized incidence rate|0.0||||||95.0|0.0|53.87|||||||
1749844|NCT00357877|3214755|Superiority or Other||Mean Difference (Net)|-0.68|Standard Deviation|0.57||0.24|2-Sided|95.0|-1.8|0.45||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|Model included treatment and site as class variables, and age and age-squared as continuous covariates.||Hypothesized a lower increment for active treatment arm, although hypothesis testing was two-sided.|
1749845|NCT00357877|3214756|Superiority or Other||Mean Difference (Net)|-0.51|Standard Error of the Mean|0.38||0.18|2-Sided|95.0|-1.25|0.23||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|treatment and site included as class variables and age and age-squared as continuous covariates.||Hypothesized lower increment in active arm, though hypothesis testing was two-sided.|
1749846|NCT00357877|3214757|Superiority or Other||Mean Difference (Net)|0.35|Standard Error of the Mean|0.57||0.54|2-Sided|95.0|-0.77|1.46||No adjustment for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALYZE to obtain final p-values.|Regression, Linear|Model included treatment and site as class variables and age and age-squared as continuous covariates.||hypothesized a reduced caries increment in active arm, though conducted two-tailed hypothesis test.|
1749847|NCT00357877|3214758|Superiority or Other||Mean Difference (Net)|0.25|Standard Error of the Mean|0.44||0.56|2-Sided|95.0|-0.6|1.11||No interim analyses were done and no adjustment made for multiple comparisons. Identical analyses were run on each imputed dataset, with results combined with SAS® PROC MIANALZE to obtain final p-values.|Regression, Linear|The primary outcome analysis included treatment and site as class variables and age and age-squared as continuous covariates.||We hypothesized a lower increment score for the active treatment group but carried out two-tailed hypothesis testing. Sample size was estimated with simulated data with rank normalized scores. We calculated that 832 participants would yield a power of 90% to detect a 20% reduction in caries incidence (from a hypothesized mean increment of 1.5), and adopted a target of 1000 randomized participants to allow for attrition.|
1749848|NCT00357656|3214776|Non-Inferiority or Equivalence|Non-inferiority by the 200% margin of non-inferiority was demonstrated if the upper confidence limit of a 95% 2-sided confidence interval for the ratio of means did not exceed 200%.|Mean ratio CI/BI|0.924||||0.001|2-Sided|95.0|0.816|1.046||one-sided p-value against the null hypothesis of ration >=200%|Hypothesis test|||The main analysis used a point estimate and a two-sided 95% confidence interval for ratio of the primary outcome measure of CI over BI combined over the three strata: stratum A: unilateral knee replacement, stratum B: hip surgery, stratum C: shoulder/elbow/ankle/knee (except knee replacement) surgery.|
1749869|NCT00356135|3214991|Superiority or Other|||||||0.0153||||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient||||
1749870|NCT00356135|3214991|Superiority or Other|||||||0.0152||||||P-value for RPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient||||
1749871|NCT00356135|3214991|Superiority or Other|||||||0.015||||||P-value for MPA (20 uM ADP) at 1 week.|Pearson Correlation Coefficient||||
1750062|NCT00352027|3215382|Superiority or Other (legacy)|||||||0.8946|||||||Cox Model||||
1749849|NCT00357552|3214788|Non-Inferiority or Equivalence|Success of the strategy is assessed according to whether the lower bound of the exact 90% confidence interval of this proportion is greater than 65%.|proportion|87.0|||||2-Sided|90.0|81.0|92.0|||||exact confidence interval|The null hypothesis was that LPV/r monotherapy provides at least a 65% short-term virologic response. The target sample size was 120 subjects. Assuming an underlying true 24 week success rate of 76%, this sample size was chosen in order to provide at least 90% power to show that the true 24 week virologic success rate of LPV/r monotherapy in this population is greater than 65%.|
1749850|NCT00357370|3214794|Superiority or Other||Mean Difference (Final Values)|-2.52|Standard Error of the Mean|3.8291|||2-Sided|95.0|-10.17|5.12|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.||
1749851|NCT00357370|3214794|Superiority or Other||Mean Difference (Final Values)|-3.05|Standard Error of the Mean|3.8302|||2-Sided|95.0|-10.69|4.6|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.||
1749852|NCT00357370|3214798|Superiority or Other||Mean Difference (Final Values)|-27.44|Standard Error of the Mean|11.4574|||2-Sided|95.0|-50.33|-4.55|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.||
1749853|NCT00357370|3214798|Superiority or Other||Mean Difference (Final Values)|-15.44|Standard Error of the Mean|11.4753|||2-Sided|95.0|-38.37|7.48|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.||
1749854|NCT00357370|3214799|Superiority or Other||Mean Difference (Final Values)|-0.78|Standard Error of the Mean|0.1903|||2-Sided|95.0|-1.16|-0.4|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.||
1749855|NCT00357370|3214799|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.1898|||2-Sided|95.0|-1.08|-0.32|||||ANCOVA was applied. No formal statistical testing was performed to compare between treatment groups.||
1749856|NCT00357097|3214829|Superiority or Other||Mean Difference (Final Values)|-3.6|||<|0.001||95.0|-5.6|-1.6|||ANCOVA||Mean difference = Ropinirole minus Placebo. Used adjusted change from baseline.||
1749857|NCT00356915|3214841|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|This was stratified by analysis center.||The superiority analysis was restricted to the itraconazole 200-mg tablets and placebo tablets dosing groups.|
1749858|NCT00356915|3214842|Non-Inferiority or Equivalence|The assumption was that the Complete Cure rate at week 52 was 35% for the active dosing groups, a sample size of 552 ITT subjects per active group would have had a 93% power for testing the proportion of subjects with Complete Cure. These computations assumed a non inferiority margin of 10% and a one-sided significance level of 0.025. Power computations were performed using nQuery Advisor, Version 5.0.|Mean Difference (Final Values)|10.0|||<|0.001|1-Sided|97.5|-1.1||||Wald's CI|The statistical analysis used Wald’s CI with Yates’ continuity correction.||The test for demonstrating non-inferiority was based on a margin of 10%. Thus, non-inferiority was established if the lower limit of the one-sided, 97.5% CI in the observed difference between the proportions of subjects by study drug with Complete Cure at week 52 (itraconazole 200-mg tablets minus itraconazole 100-mg capsules) was greater than -10%. The non-inferiority analysis was restricted to the active dosing groups.|
1749859|NCT00356915|3214843|Non-Inferiority or Equivalence|The non-inferiority was established if the lower limit of the one-sided, 97.5% CI in the observed difference between the proportions of subjects by study drug with Complete Cure at week 52 (itraconazole 200-mg tablets minus itraconazole 100-mg capsules) was greater than -10%. No p-value was calculated for this endpoint.|Wald's CI|0.56|||||1-Sided|97.5|-4.3|||||||Comparison between the 2 itraconazole groups was based on lower bound of the 97.5% confidence interval for the difference. The non-inferiority analysis was restricted to the active dosing groups.|
1749860|NCT00356915|3214844|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|This was stratified by analysis center.||P-Value from a Cochran-Mantel-Haenszel test, . The superiority analysis was restricted to the itraconazole 200-mg tablets and placebo tablets dosing groups.|
1749861|NCT00356811|3214869|Superiority or Other||percentage of participants|50.9|||||2-Sided|95.0|37.3|64.4|||||The estimated value represents the percentage of participants with a confirmed CR or PR.||
1749862|NCT00356369|3214964|Non-Inferiority|Criterion indicative of non-inferiority: Upper limit of the standardized asymptotic 95% CI on the difference between MenACWY- TT and (minus) MenACWY in the incidence of Grade 3 systemic symptoms was below 5%.|Difference in % Grade 3 general symptoms|1.34|||||2-Sided|95.0|-1.64|3.09||||||To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to the licensed MenACWY vaccine in terms of the incidence of any Grade 3 systemic symptom within 4 days after vaccination.|
1749863|NCT00356369|3214965|Non-Inferiority|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in % for rSBA-MenY antibodies|8.05|||||2-Sided|95.0|1.72|16.17||||||To evaluate the non-inferiority of the vaccine response* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.|
1749864|NCT00356369|3214965|Non-Inferiority|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in%for rSBA-MenW-135 antibody|4.58|||||2-Sided|95.0|-0.07|11.49||||||To evaluate the non-inferiority of the vaccine response* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.|
1749865|NCT00356369|3214965|Non-Inferiority|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%.|Difference in % for rSBA-MenC antibodies|4.18|||||2-Sided|95.0|-1.03|11.36||||||To evaluate the non-inferiority of the vaccine response* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.|
1749866|NCT00356369|3214965|Non-Inferiority|Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was greater than (>) -15%.|Difference in % for rSBA-MenA antibodies|13.0|||||2-Sided|95.0|3.52|23.5||||||To evaluate the non-inferiority of the vaccine response* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.|
1749867|NCT00356304|3214969|Superiority or Other||||||<|0.05|||||||ANCOVA||||
1749874|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-9.9|||<|0.0001|2-Sided|95.0|-14.67|-5.09||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749875|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-11.0|||<|0.0001|2-Sided|95.0|-15.64|-6.32||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749876|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-12.0|||<|0.0001|2-Sided|95.0|-17.91|-6.09||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749877|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-13.0|||<|0.0001|2-Sided|95.0|-18.81|-7.32||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749878|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-16.0|||<|0.0001|2-Sided|95.0|-20.98|-10.75||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749879|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-3.3|||<|0.1971|2-Sided|95.0|-8.31|1.74||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749880|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-11.0|||<|0.0001|2-Sided|95.0|-15.92|-6.24||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749881|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|1.6|||<|0.4954|2-Sided|95.0|-3.11|6.38||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749882|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-23.0|||<|0.0001|2-Sided|95.0|-29.61|-15.63||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749883|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-22.0|||<|0.0001|2-Sided|95.0|-28.42|-14.77||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749884|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-20.0|||<|0.0001|2-Sided|95.0|-27.09|-12.26||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749885|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-18.0|||<|0.0001|2-Sided|95.0|-25.58|-11.09||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749886|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-34.0|||<|0.0001|2-Sided|95.0|-39.99|-28.42||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749887|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-7.3|||<|0.0127|2-Sided|95.0|-13.04|-1.6||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749888|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-27.0|||<|0.0001|2-Sided|95.0|-33.4|-20.33||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1750043|NCT00352417|3215310|Superiority or Other||||||<|0.01|||||||ANCOVA|ANCOVA was performed on the natural log transformed data|||
1750044|NCT00352417|3215311|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1749889|NCT00356135|3214992|Superiority or Other||Least Squares Mean Difference|-3.1|||<|0.3466|2-Sided|95.0|-9.5|3.37||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749890|NCT00356135|3214993|Superiority or Other|||||||0.1101|||||||F-test|||The variance of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the variance of MPA for patients not using clopidogrel at this time.|
1749891|NCT00356135|3214993|Superiority or Other|||||||0.1824|||||||t-test, 2 sided|||The mean of MPA 20 uM ADP at the end of Clopidogrel open label of patients on chronic clopidogrel at the time of qualifying events was compared to the mean MPA of patients not using clopidogrel at this time.|
1749892|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-12.0|||<|0.0001|2-Sided|95.0|-16.8|-6.82||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749893|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-13.0|||<|0.0001|2-Sided|95.0|-17.41|-7.72||P-value for 2 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749894|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-11.0|||<|0.0001|2-Sided|95.0|-15.79|-5.79||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749895|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-12.0|||<|0.0001|2-Sided|95.0|-17.21|-7.5||P-value for 1 Week (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749896|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-20.0|||<|0.0001|2-Sided|95.0|-24.81|-15.64||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749897|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-4.1|||<|0.0752|2-Sided|95.0|-8.58|0.42||P-value for 24 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749898|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-17.0|||<|0.0001|2-Sided|95.0|-21.55|-12.37||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749899|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-1.4|||<|0.5501|2-Sided|95.0|-5.85|3.14||P-value for 2 Hour (5 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749900|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-15.0|||<|0.0001|2-Sided|95.0|-20.59|-9.22||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749901|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-15.0|||<|0.0001|2-Sided|95.0|-20.3|-9.22||P-value for 2 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749902|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-15.0|||<|0.0001|2-Sided|95.0|-19.87|-9.32||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749903|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-15.0|||<|0.0001|2-Sided|95.0|-19.96|-9.65||P-value for 1 Week (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749904|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-29.0|||<|0.0001|2-Sided|95.0|-33.2|-23.94||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.|Comparison of MPA to 20 uM ADP at 24 hours|
1750045|NCT00352417|3215312|Superiority or Other|||||||0.37|||||||t-test, 2 sided|Satterthwaite's method|||
1749905|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-4.2|||<|0.068|2-Sided|95.0|-8.82|0.32||P-value for 24 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749906|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-23.0|||<|0.0001|2-Sided|95.0|-29.3|-17.51||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 60/10 mg minus Clopidogrel 75/75 mg.||
1749907|NCT00356135|3214994|Superiority or Other||Least Squares Mean Difference|-2.4|||<|0.4055|2-Sided|95.0|-8.22|3.35||P-value for 2 Hour (20 uM ADP). Mixed model with actual value at each timepoint as dependent variable, baseline value as covariate, treatment, catagorical timepoint, and time by treatment interaction as fixed effects, and subject as random effect.|Repeated Measures Analysis||Least Squares Mean Difference = Prasugrel 10/10 mg minus Clopidogrel 75/75 mg.||
1749908|NCT00356135|3214995|Superiority or Other||Mean Difference (Final Values)|-13.98|||<|0.0001||95.0|-19.26|-8.71|||ANCOVA||||
1749909|NCT00356135|3214995|Superiority or Other||Mean Difference (Final Values)|-13.91|||<|0.0001||95.0|-19.1|-8.73|||ANOVA|Treatment and study sites are fixed effects and MPA right before the randomization treatment period is a covariate in the model.|Mean Difference is for Prasugrel 10/10 mg arm minus Clopidogrel 75/75 mg arm.||
1749910|NCT00356057|3215001|Superiority|||||||0.047|||||||t-test, 2 sided||||
1749911|NCT00356057|3215001|Superiority|||||||0.039|||||||t-test, 2 sided||||
1749912|NCT00356057|3215002|Superiority|||||||0.001|||||||t-test, 2 sided||||
1749913|NCT00356057|3215002|Superiority||||||<|0.001|||||||t-test, 2 sided||||
1749914|NCT00356057|3215003|Superiority|||||||0.008|||||||t-test, 2 sided||||
1749915|NCT00356057|3215003|Superiority|||||||0.02|||||||t-test, 2 sided||||
1749916|NCT00356057|3215004|Superiority|||||||0.014|||||||t-test, 2 sided||||
1749917|NCT00356057|3215004|Superiority|||||||0.005|||||||t-test, 2 sided||||
1749918|NCT00356057|3215008|Superiority|||||||0.006|||||||t-test, 2 sided||||
1749919|NCT00356057|3215008|Superiority|||||||0.03|||||||t-test, 2 sided||||
1749920|NCT00356057|3215011|Equivalence|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence.||||||0.0009|||||||t-test, 1 sided||||
1749921|NCT00356057|3215012|Equivalence|Complication-free rate was evaluated in an equivalence (non-inferiority) format compared to a target of 85% minus delta (10%), where delta is the clinically significant difference for establishing equivalence.||||||0.0596|||||||t-test, 1 sided||||
1749922|NCT00356057|3215013|Superiority|||||||0.405|||||||t-test, 2 sided||||
1749923|NCT00356057|3215013|Superiority|||||||0.437|||||||t-test, 2 sided||||
1749924|NCT00356031|3215017|Other||||||<|0.05|||||||t-test, 1 sided||||
1749925|NCT00356031|3215018|Other||||||<|0.05|||||||t-test, 1 sided||||
1749926|NCT00355914|3215020|Superiority or Other||||||>|0.05||||||Results were considered statistically significant if the P value was less than 0.05.|t-test, 2 sided|||baseline, 3, 6, 12, 18, and 24 months between groups|
1749927|NCT00355914|3215021|Superiority or Other||||||>|0.05||||||Results were considered statistically significant if the P value was less than 0.05.|t-test, 2 sided|||compared baseline, 3, 6, 12, 18, and 24 months between groups|
1749928|NCT00355797|3215022|Superiority or Other||Median Difference (Final Values)|1.91|Standard Deviation|21.34||0.505|2-Sided|95.0|-3.8|7.63|||t-test, 2 sided|||The purpose of endpoint was to evaluate the percent change in pulse pressure during test. The null hypothesis was the mean percent change for patients with their device programmed to CLS is greater or equal to the mean percent change for the same patients with their device without rate adaptative pacing.|
1749929|NCT00355797|3215022|Superiority or Other||Median Difference (Final Values)|-1.42|Standard Deviation|17.74||0.552|2-Sided|95.0|-6.17|3.33|||t-test, 2 sided|||The purpose of endpoint was to evaluate the percent change in pulse pressure during test. The null hypothesis was the mean percent change for patients with their device programmed to CLS is greater or equal to the mean percent change for the same patients with their device in accelerometer.|
1749930|NCT00355797|3215029|Superiority or Other||Mean Difference (Net)|9.17|Standard Deviation|15.9||0.004|2-Sided|95.0|3.24|15.11|||t-test, 2 sided|||The endpoint will compare the composite percent change in ADL performance for patients while their devices are programmed to CLS and accelerometer pacing modes, using the no rate adaptive pacing mode as the baseline. Null hypothesis: mean composite of percent change for patients with their device programmed to CLS is less than or equal to the mean composite of percent change for the same patients with their device in accelerometer.|
1749931|NCT00355706|3215039|Superiority or Other (legacy)|||||||0.56|||||||ANOVA||||
1749932|NCT00355706|3215040|Superiority or Other (legacy)|||||||0.892|||||||ANOVA||||
1749933|NCT00355706|3215041|Superiority or Other (legacy)|||||||0.964|||||||ANOVA||||
1749934|NCT00355394|3215062|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)||||
1749935|NCT00355394|3215063|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1749936|NCT00355394|3215064|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1749937|NCT00355394|3215065|Superiority or Other|||||||0.46|||||||Fisher Exact||||
1749938|NCT00355394|3215066|Superiority or Other|||||||0.02|||||||Fisher Exact||||
1749939|NCT00355394|3215067|Superiority or Other|||||||0.03|||||||Fisher Exact||||
1749961|NCT00354835|3215135|Superiority or Other (legacy)||The incidence of febrile neutropenia|0.0881|||||1-Sided|95.0||0.1216||||||Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.|
1749940|NCT00355342|3215073|Equivalence|The null hypothesis for the primary measure is that the difference between the effects of fluticasone propionate/salmeterol combination product 250/50mcg BID and salmeterol 50mcg BID on the change in BMD assessed at the L1-L4 region of the spine is greater than 1 %/year.|Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.26|||2-Sided|95.0|-0.78|0.24|||||Analysis Model: Percent change from baseline BMD = treatment + time (years) + treatment*time + baseline BMD + sex + investigator + age + BMI + FEV1 severity + b/l activity level + b/l calcium supp. use + smoking status|The analysis is presented for slope estimate calculated for the percent change from Baseline values at Week 26, 52, 78, 104, 130, and 156.|Age split by category (40-64 years old, 65 or older). FEV1 severity based on GOLD Stage (Mild/Moderate, Severe/Very Severe). Activity based on 0-10 Physical Activity Scale (split by median, <7, >=7). Slope estimates based on treatment*time via repeated measures model with unstructured covariance.
1749941|NCT00355342|3215074|Equivalence|The null hypothesis for the primary measure is that the difference between the effects of fluticasone propionate/salmeterol combination product 250/50mcg BID and salmeterol 50mcg BID on the change in BMD assessed at the L1-L4 region of the spine is greater than 1 %/year.|Mean Difference (Final Values)|0.8|Standard Error of the Mean|0.36|||2-Sided|95.0|0.06|1.49|||||Analysis Model: Percent change from baseline BMD = treatment + time (years) + treatment*time + baseline BMD + sex + investigator + age + BMI + FEV1 severity + b/l activity level + b/l calcium supp. use + smoking status.|The analysis is presented for slope estimate calculated for the percent change from Baseline values at Week 26, 52, 78, 104, 130, and 156.|Age split by category (40-64 years old, 65 or older). FEV1 severity based on GOLD Stage (Mild/Moderate, Severe/Very Severe). Activity based on 0-10 Physical Activity Scale (split by median, <7, >=7). Slope estimates based on treatment*time via repeated measures model with unstructured covariance.
1749942|NCT00355199|3215077|Superiority||Hazard Ratio (HR)|0.93|||<|0.05|2-Sided|95.0|0.57|1.52|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)||
1749943|NCT00355199|3215078|Superiority||Hazard Ratio (HR)|0.6|||<|0.05|2-Sided|95.0|0.29|1.21|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)||
1749944|NCT00355199|3215080|Superiority||Hazard Ratio (HR)|0.99|||<|0.05|2-Sided|95.0|0.66|1.48|||Regression, Cox||HR refers to R-HDS (R-CHOP is the reference level)||
1749945|NCT00355147|3215081|Superiority or Other||Odds Ratio (OR)|1.57||||0.21|2-Sided|95.0|0.77|3.21|||Regression, Logistic|||Within Group Attention Group Pre Post Comparison Compliance with Hypertension Medication.|
1749946|NCT00355147|3215081|Superiority or Other||Odds Ratio (OR)|3.68||||0.0004|2-Sided|95.0|1.81|7.48|||Regression, Logistic|||Within Group Intervention Pre Post Comparison Compliance with Hypertension Medication|
1749947|NCT00355147|3215081|Superiority or Other||Odds Ratio (OR)|2.34||||0.096|2-Sided|95.0|0.86|6.4|||Regression, Logistic|||Between Group Intervention Pre Post Comparison Compliance with Hypertension Medication|
1749948|NCT00355147|3215082|Superiority or Other||Odds Ratio (OR)|3.83||||0.0004|2-Sided|95.0|1.83|8.01|||Regression, Logistic|||Within Group Attention Control Pre Post Comparison Compliance with Statin Medication.|
1749949|NCT00355147|3215082|Superiority or Other||Odds Ratio (OR)|5.98||||0.0001|2-Sided|95.0|2.81|12.76|||Regression, Logistic|||Within Group Intervention Pre Post Comparison Compliance with Statin Medication|
1749950|NCT00355147|3215082|Superiority or Other||Odds Ratio (OR)|1.56||||0.05|2-Sided|95.0|0.54|4.48|||Regression, Logistic|||Between Group Intervention Pre Post Comparison Compliance with Statin Medication|
1749951|NCT00355147|3215083|Superiority or Other||Odds Ratio (OR)|0.51||||0.407|2-Sided|95.0|0.1|2.7|||Regression, Logistic|||Within Group attention control group intervention pre post comparison compliance with Diabetes Medication|
1749952|NCT00355147|3215083|Superiority or Other||Odds Ratio (OR)|3.45||||0.036|2-Sided|95.0|1.08|10.96|||Regression, Logistic|||Within group Intervention Pre Post Comparison Compliance with Diabetes Medication|
1749953|NCT00355147|3215083|Superiority or Other||Odds Ratio (OR)|6.74||||0.06|2-Sided|95.0|0.88|51.31|||Regression, Logistic||||
1749954|NCT00355147|3215084|Superiority or Other||Mean Difference (Net)|0.12||||0.66|2-Sided||||||Mixed Models Analysis|Adjusted by site, strata, baseline score, treatment group, month and group by month interaction|The score is the change from baseline to six months between groups.||
1749955|NCT00355147|3215085|Superiority or Other||Mean Difference (Net)|0.47|Standard Error of the Mean|0.23||0.05|2-Sided|||||Adjusted for site, strata, baseline value, treatment group, month of assessment, treatment group x month, random subject effect|Mixed Models Analysis||This score represents change from baseline to three months across groups.|This is an analysis of the Perceived Energy Domain within the Stroke Specific Quality of Life Measure|
1749956|NCT00355147|3215085|Superiority or Other||Mean Difference (Net)|0.05|Standard Error of the Mean|0.11||0.69|2-Sided||||||Mixed Models Analysis|Adjusted for site, strata, baseline score, randomized group, month and the group by month interaction|This score represents change from baseline to six months across the groups.|This is an analysis of the outcome, Stroke Specific Quality of Life Overall Total Score.|
1749957|NCT00354835|3215132|Superiority or Other (legacy)|||||||0.036|||||||Fisher Exact|||The incidences of grade 3 or higher diarrhea between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by Fisher's exact test.|
1749958|NCT00354835|3215132|Superiority or Other (legacy)|||||||0.99|||||||Fisher Exact|||The incidences of grade 3 or higher neutropenia, with or without fever between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by the Fisher's exact test.|
1749959|NCT00354835|3215135|Superiority or Other (legacy)||The incidence of vomiting|0.0104|||||1-Sided|95.0||0.0224||||||Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.|
1749960|NCT00354835|3215135|Superiority or Other (legacy)||The incidence of platelet count decrease|0.3264|||||1-Sided|95.0||0.3819||||||Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.|
1750046|NCT00352417|3215313|Superiority or Other|||||||0.97|||||||t-test, 2 sided|Satterthwaite's method|||
1749962|NCT00354835|3215135|Superiority or Other (legacy)||The incidence of nausea or hepatopathy|0.0052|||||1-Sided|95.0||0.0137||||||Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.|
1749963|NCT00354835|3215135|Superiority or Other (legacy)||The incidence of anemia|0.2798|||||1-Sided|95.0||0.3329||||||Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.|
1749964|NCT00354835|3215135|Superiority or Other (legacy)||The incidence of vomiting|0.0405|||||1-Sided|95.0||0.0623||||||Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.|
1749965|NCT00354835|3215135|Superiority or Other (legacy)||The incidence of platelet count decrease|0.1216|||||1-Sided|95.0||0.1577||||||Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.|
1749966|NCT00354835|3215135|Superiority or Other (legacy)||The incidence of febrile neutropenia|0.1351|||||1-Sided|95.0||0.1729||||||Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.|
1749967|NCT00354835|3215135|Superiority or Other (legacy)||The incidence of nausea or hepatopathy|0.027|||||1-Sided|95.0||0.0449||||||Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.|
1749968|NCT00354835|3215135|Superiority or Other (legacy)||The incidence of anemia|0.2613|||||1-Sided|95.0||0.31||||||Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. Comparing the incidence of anemia with VAC on ARST0531 to the historical rate of 0.40 with VAC on D9803. The 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.|
1749969|NCT00354432|3215157|Superiority or Other|||||||0.2081||||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|ANCOVA|||Null hypothesis was that there was no difference in quality of life between the four groups at 12 weeks.|
1749970|NCT00354432|3215158|Superiority or Other|||||||0.3455||||||This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.|Mixed Models Analysis|A mixed effects repeated measures analysis of variance was used with the baseline means constrained to be equal in the four groups.||The null hypothesis was that there was no difference in the hot flash severity score at 12 weeks.|
1749971|NCT00354341|3215159|Superiority or Other||||||<|0.001|||||||Chi-squared, Corrected||||
1749972|NCT00354341|3215160|Superiority or Other|||||||0.2913|||||||ANCOVA with LOCF||||
1749973|NCT00354341|3215161|Superiority or Other|||||||0.1578|||||||ANCOVA with LOCF||||
1749974|NCT00354341|3215162|Superiority or Other|||||||0.5681|||||||ANCOVA with LOCF||||
1749975|NCT00354341|3215163|Superiority or Other|||||||0.8864|||||||ANCOVA with LOCF||||
1749976|NCT00354341|3215164|Superiority or Other|||||||0.8811||||||P-value was calculated by ANCOVA with last observation carry forward (LOCF) method.|ANCOVA with LOCF||||
1749977|NCT00354159|3215183|Superiority or Other||Hazard Ratio (HR)|1.48||||0.368|2-Sided|95.0|0.63|3.5||The P-value is from the Andersen-Gill model which adjusts for multiple VT/VF episodes per subject.|Andersen-Gill Model|Andersen-Gill model included a term for Treatment Arm. This model adjusts for multiple events per subject.||"Null Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is the same between the Treatment Arm and the Control Arm.~Alternative Hypothesis: Rate of VT/VF episodes during the 12-month randomized period is different between the Treatment Arm and the Control Arm."|
1749978|NCT00354159|3215184|Superiority or Other|||||||0.583|||||||Mixed Models Analysis|Response was change in MNLWHF score from baseline. Model adjusted for baseline MNLWHF score. Negative changes mean an improvement in MNLWHF score.||"Null Hypothesis: There is no difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm.~Alternative Hypothesis: There is a difference in the change in MNLWHF score from baseline to 12-months between the Treatment Arm and Control Arm."|
1749979|NCT00354159|3215187|Superiority or Other|||||||0.154|||||||Mixed Models Analysis|||"Null Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is the same between the Treatment arm and Control arm.~Alternative Hypothesis: The change from baseline to the 12-month follow-up visit in eGFR values is different between the Treatment arm and Control arm."|
1749980|NCT00354159|3215188|Superiority or Other|||||||0.996|||||||Mixed Models Analysis|||"Null Hypothesis: The change in 6-minute hall walk distance is not different between the Treatment and Control Arms.~Alternative Hypothesis: The change in 6-minute hall walk distance is different between the Treatment and Control Arms."|
1749981|NCT00354159|3215189|Superiority or Other||Odds Ratio (OR)|1.27||||0.292|2-Sided|95.0|0.82|1.96|||Proportional odds regression model||Direction for odds ratio is the odds of improvement in the Treatment arm versus the odds of improvement in the Control arm.|"Null Hypothesis: There is no difference in the change in NYHA functional class between the Treatment and Control Arms.~Alternative Hypothesis: There is a difference in the change in NYHA functional class between the Treatment and Control Arms."|
1749982|NCT00354159|3215190|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||"Null Hypothesis: The average daily median ePAD is not different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period.~Alternative Hypothesis: The average daily median ePAD is different among Control Arm subjects that have and that do not have a heart failure related event during the 12-month follow-up period."|
1749983|NCT00354159|3215191|Superiority or Other|||||||0.033|||||||t-test, 2 sided|||"Null hypothesis: Average daily median ePAD is the same between the Treatment and Control arms.~Alternative hypothesis: Average daily median ePAD is the different between the Treatment and Control arms."|
1749984|NCT00354159|3215192|Superiority or Other|||||||0.145|||||||Negative-Binomial Regression|||The null hypothesis is that the rate of cardiovascular medication changes is the same between the Treatment Arm and Control Arm.|
1749985|NCT00354159|3215193|Superiority or Other||Hazard Ratio (HR)|0.77||||0.599|2-Sided|95.0|0.29|2.06|||Regression, Cox|The treatment to control hazard ratio and 95% confidence interval was estimated using a univariate Cox Regression Model|Hazard ratio estimates the hazard of death in the treatment group relative to the control group.|"Null hypothesis: Survival during the 12-month randomized follow-up period is the same between the treatment and control groups.~Alternative hypothesis: Survival during the 12-month randomized period is different between the treatment and control groups."|
1749986|NCT00354159|3215196|Superiority or Other||Odds Ratio (OR)|1.06||||0.758|2-Sided|95.0|0.73|1.54||P-value is from a proportional odds model comparing the distribution of composite endpoint response between the treatment arm and control arm.|Proportional odds model||Odds ratio represents the odds of improved score in the treatment group relative to the control group.|"Null Hypothesis: Distribution of composite response endpoint is the same between the treatment arm and the control arm.~Alternative Hypothesis: Distribution of composite response endpoint is different between the treatment arm and the control arm."|
1749987|NCT00354159|3215197|Superiority or Other||Hazard Ratio (HR)|0.76||||0.088|2-Sided|95.0|0.56|1.04|||Andersen-Gill Model|The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"Null Hypothesis: The all cause event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The all cause event rate between the treatment arm and control arm is different."|
1749988|NCT00354159|3215198|Superiority or Other||Hazard Ratio (HR)|0.87||||0.505|2-Sided|95.0|0.57|1.32|||Regression, Cox|The treatment and control hazard ratio and 95% confidence interval was estimated using a univariate cox Regression Model.|Hazard Ratio is for the Treatment Arm relative to the Control Arm|"Null Hypothesis: Freedom from death or HF-related hospitalization is the same between the treatment arm and the control arm.~Alternative Hypothesis: Freedom from death or HF-related hospitalization is different between the treatment arm and the control arm."|
1749989|NCT00354159|3215199|Superiority or Other||Hazard Ratio (HR)|0.89||||0.527|2-Sided|95.0|0.62|1.28||The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Andersen-Gill Model||Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"Null Hypothesis: The CV-related event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The CV-related event rate between the treatment arm and control arm is different."|
1749990|NCT00354159|3215200|Superiority or Other|||||||0.574|||||||Wilcoxon (Mann-Whitney)|||"Null Hypothesis: mu(Treatment) = mu(Control) Alternative Hypothesis: mu(Treatment) ne mu(Control)~where mu is the percentage of hospitalized days for heart failure."|
1749991|NCT00354159|3215201|Superiority or Other||Hazard Ratio (HR)|0.99||||0.978|2-Sided|95.0|0.61|1.61||The P-value is from the Andersen-Gill model, an extension of the Cox proportional hazards model for multiple events.|Andersen-Gill||Hazard Ratio is for the Treatment Arm relative to the Control Arm.|"The study was originally powered at 80% to detect a 25% risk reduction between the treatment arm and control arm with a type I error rate of 0.05. Under these assumptions 648 HF-related events from approximately 1300 subjects were required. The study stopped after 400 were randomized.~Null Hypothesis: The HF-related event rate is the same between the treatment arm and control arm.~Alternative Hypothesis: The HF-related event rate between the treatment arm and control arm is different."|
1749992|NCT00354159|3215203|Superiority or Other||6-month survival rate|90.5|||<|0.001|1-Sided|97.5|87.7|||The survival estimate at 6-months post-implant was compared to 80%. The comparison was made using the cumulative hazard [e.g. log survival estimate] for the variance.|Survival estimate at 6-months|The survival estimate at 6-months post-implant was compared to 80%.||"Null hypothesis: Freedom from Chronicle system-related complications at 6-months post-implant is less than or equal to 80%.~Alternative hypothesis: Freedom from Chronicle system-related complications at 6-months is greater than 80%."|
1749993|NCT00354029|3215209|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1749994|NCT00353873|3215211|Superiority or Other||Odds Ratio (OR)|1.16||||0.535|2-Sided|95.0|0.7|1.9|||Regression, Logistic||||
1749995|NCT00353873|3215212|Superiority or Other||Odds Ratio (OR)|1.31||||0.389|2-Sided|95.0|0.7|2.4|||Regression, Logistic||||
1749996|NCT00353873|3215213|Non-Inferiority or Equivalence|Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.|Mean Difference (Net)|9.3|Standard Error of the Mean|3.08||0.003|2-Sided|95.0|3.2|15.3|||ANCOVA||||
1749997|NCT00353873|3215214|Non-Inferiority or Equivalence|Non-inferiority was tested using a one-sided significance level of 2.5%. If the lower confidence interval for the difference SFC-FP falls above -12 L/min the once daily SFC treatment combination was deemed to be statistically non-inferior. In the event that the lower confidence limit (2.5% 1-sided significance) exceeded 0, and using a separate closed testing procedure, superiority could be established.|Mean Difference (Net)|7.6|Standard Error of the Mean|3.01||0.012|2-Sided|95.0|1.7|13.5|||ANCOVA||||
1749998|NCT00353496|3215239|Superiority or Other||Hazard Ratio (HR)|0.47|||<|0.001|2-Sided|95.0|0.3|0.73||No p-value adjustment for multiple comparisons.|Log Rank|The log rank test was stratified according to progression status at baseline and prior therapy.|||
1750041|NCT00353262|3215275|Superiority or Other||Geometric mean ratio|0.9|||||2-Sided|90.0|0.79|1.02||||||Cycle 2, Day 1 versus Cycle 1, Day 1|
1749999|NCT00353418|3215251|Superiority or Other||Odds Ratio (OR)|1.15||||0.6119||95.0|0.68|1.93|||Cochran-Mantel-Haenszel|||"Sample sizes of 133 and 267 patients for RBV 800 mg daily and RBV 1000 or 1200 mg daily, respectively, provided the following probabilities of detecting the specified differences in SVR with a 0.05 level two-sided chi-square test of significance:~RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.40; Probability - 0.49~RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.45; Probability - 0.83"|
1750000|NCT00353262|3215267|Superiority or Other||Geometric mean ratio|0.99|||||2-Sided|90.0|0.91|1.07||||||Free Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1|
1750001|NCT00353262|3215267|Superiority or Other||Geometric mean ratio|1.0|||||2-Sided|90.0|0.92|1.08||||||Free Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2|
1750002|NCT00353262|3215267|Superiority or Other||Geometric mean ratio|1.01|||||2-Sided|90.0|0.94|1.09||||||Free Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2|
1750003|NCT00353262|3215267|Superiority or Other||Geometric mean ratio|0.99|||||2-Sided|90.0|0.93|1.05||||||Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1|
1750004|NCT00353262|3215267|Superiority or Other||Geometric mean ratio|1.01|||||2-Sided|90.0|0.95|1.08||||||Total Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2|
1750005|NCT00353262|3215267|Superiority or Other||Geometric mean ratio|1.02|||||2-Sided|90.0|0.96|1.09||||||Total Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2|
1750006|NCT00353262|3215269|Superiority or Other||Geometric mean ratio|1.11|||||2-Sided|90.0|1.01|1.23||||||Total Platinum: Cycle 3, Day 1 versus Cycle 2, Day 1|
1750007|NCT00353262|3215269|Superiority or Other||Geometric mean ratio|1.34|||||2-Sided|90.0|1.21|1.48||||||Total Platinum: Cycle 3, Day 1 versus Cycle 1, Day 2|
1750008|NCT00353262|3215269|Superiority or Other||Geometric mean ratio|1.2|||||2-Sided|90.0|1.09|1.33||||||Total Platinum: Cycle 2, Day 1 versus Cycle 1, Day 2|
1750009|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|0.91|||||2-Sided|90.0|0.83|1.0||||||FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1|
1750010|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|0.83|||||2-Sided|90.0|0.76|0.91||||||FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1|
1750011|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|0.91|||||2-Sided|90.0|0.83|1.0||||||FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1|
1750012|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|0.78|||||2-Sided|90.0|0.59|1.03||||||5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1|
1750013|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|0.58|||||2-Sided|90.0|0.44|0.76||||||5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1|
1750014|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|0.74|||||2-Sided|90.0|0.56|0.98||||||5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1|
1750015|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|1.1|||||2-Sided|90.0|0.81|1.49||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1|
1750016|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|0.96|||||2-Sided|90.0|0.71|1.3||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1|
1750017|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|0.87|||||2-Sided|90.0|0.65|1.18||||||5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1|
1750018|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|0.85|||||2-Sided|90.0|0.65|1.1||||||Capecitabine: Cycle 3, Day 1 versus Cycle 1, Day 1|
1750019|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|1.03|||||2-Sided|90.0|0.78|1.34||||||Capecitabine: Cycle 3, Day 1 versus Cycle 2, Day 1|
1750020|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|0.82|||||2-Sided|90.0|0.63|1.08||||||Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1|
1750021|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|0.87|||||2-Sided|90.0|0.71|1.06||||||5'-DFUR: Cycle 3, Day 1 versus Cycle 2, Day 1|
1750022|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|0.64|||||2-Sided|90.0|0.53|0.79||||||5'-DFUR: Cycle 3, Day 1 versus Cycle 1, Day 1|
1750023|NCT00353262|3215271|Superiority or Other||Geometric mean ratio|0.74|||||2-Sided|90.0|0.61|0.9||||||5'-DFUR: Cycle 2, Day 1 versus Cycle 1, Day 1|
1750024|NCT00353262|3215273|Superiority or Other||Geometric mean ratio|1.0|||||2-Sided|90.0|0.93|1.07||||||FBAL: Cycle 3, Day 1 versus Cycle 2, Day 1|
1750025|NCT00353262|3215273|Superiority or Other||Geometric mean ratio|0.97|||||2-Sided|90.0|0.9|1.04||||||FBAL: Cycle 3, Day 1 versus Cycle 1, Day 1|
1750026|NCT00353262|3215273|Superiority or Other||Geometric mean ratio|0.97|||||2-Sided|90.0|0.91|1.04||||||FBAL: Cycle 2, Day 1 versus Cycle 1, Day 1|
1750027|NCT00353262|3215273|Superiority or Other||Geometric mean ratio|0.97|||||2-Sided|90.0|0.78|1.19||||||5-FU: Cycle 3, Day 1 versus Cycle 2, Day 1|
1750028|NCT00353262|3215273|Superiority or Other||Geometric mean ratio|0.79|||||2-Sided|90.0|0.64|0.97||||||5-FU: Cycle 3, Day 1 versus Cycle 1, Day 1|
1750029|NCT00353262|3215273|Superiority or Other||Geometric mean ratio|0.81|||||2-Sided|90.0|0.66|1.01||||||5-FU: Cycle 2, Day 1 versus Cycle 1, Day 1|
1750030|NCT00353262|3215273|Superiority or Other||Geometric mean ratio|1.25|||||2-Sided|90.0|1.0|1.55||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 2, Day 1|
1750031|NCT00353262|3215273|Superiority or Other||Geometric mean ratio|1.08|||||2-Sided|90.0|0.86|1.34||||||5'-DFCR: Cycle 3, Day 1 versus Cycle 1, Day 1|
1750032|NCT00353262|3215273|Superiority or Other||Geometric mean ratio|0.86|||||2-Sided|90.0|0.69|1.08||||||5'-DFCR: Cycle 2, Day 1 versus Cycle 1, Day 1|
1750033|NCT00353262|3215273|Superiority or Other||Geometric mean ratio|1.17|||||2-Sided|90.0|0.96|1.44||||||Capecitabine: Cycle 3, Day 1 to Cycle 1, Day 1|
1750034|NCT00353262|3215273|Superiority or Other||Geometric mean ratio|1.16|||||2-Sided|90.0|0.94|1.42||||||Capecitabine: Cycle 3, Day 1 to Cycle 2, Day 1|
1750035|NCT00353262|3215273|Superiority or Other||Geometric mean ratio|1.02|||||2-Sided|90.0|0.83|1.24||||||Capecitabine: Cycle 2, Day 1 versus Cycle 1, Day 1|
1750036|NCT00353262|3215274|Superiority or Other||Geometric mean ratio|0.97|||||2-Sided|90.0|0.94|1.0||||||Cycle 3, Day 1 to Cycle 2, Day 1|
1750037|NCT00353262|3215274|Superiority or Other||Geometric mean ratio|1.02|||||2-Sided|90.0|0.98|1.05||||||Cycle 3, Day 1 to Cycle 1, Day 2|
1750038|NCT00353262|3215274|Superiority or Other||Geometric mean ratio|1.05|||||2-Sided|90.0|1.01|1.08||||||Cycle 2, Day 1 versus Cycle 1, Day 2|
1750039|NCT00353262|3215275|Superiority or Other||Geometric mean ratio|0.97|||||2-Sided|90.0|0.85|1.1||||||Cycle 3, Day 1 to Cycle 2, Day 1|
1750040|NCT00353262|3215275|Superiority or Other||Geometric mean ratio|0.87|||||2-Sided|90.0|0.76|0.99||||||Cycle 3, Day 1 versus Cycle 1, Day 1|
1750047|NCT00352053|3215331|Superiority or Other|||||||0.29||||||No adjustments for multiple comparisons were made.|Log Rank|No adjustments were made.||Null hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are equal. Alternative hypothesis: The survival functions for the tenofovir DF and placebo groups up to Week 48 are different (two-sided).|
1750048|NCT00352053|3215338|Superiority or Other|||||||0.48||||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).|
1750049|NCT00352053|3215339|Superiority or Other|||||||0.22||||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).|
1750050|NCT00352053|3215346|Superiority or Other|||||||0.38||||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 for the tenofovir DF and placebo groups is different (two-sided).|
1750051|NCT00352053|3215347|Superiority or Other|||||||1||||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 for the tenofovir DF and placebo groups is different (two-sided).|
1750052|NCT00352053|3215354|Superiority or Other|||||||0.67||||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 48 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).|
1750053|NCT00352053|3215355|Superiority or Other|||||||0.67||||||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.||Null hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is equal. Alternative hypothesis: Percentage of participants who had at least a 1.0 log10 copies/mL decrease from baseline to Week 24 in HIV-1 RNA for the tenofovir DF and placebo groups is different (two-sided).|
1750054|NCT00352053|3215362|Superiority or Other|||||||0.63||||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4% for the tenofovir DF and placebo groups are different (two-sided).|
1750055|NCT00352053|3215363|Superiority or Other|||||||0.26||||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma CD4% for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4% for the tenofovir DF and placebo groups are different (two-sided).|
1750056|NCT00352053|3215370|Superiority or Other|||||||0.47||||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).|
1750057|NCT00352053|3215371|Superiority or Other|||||||0.71||||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma CD4 count for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in CD4 count for the tenofovir DF and placebo groups are different (two-sided).|
1750058|NCT00352053|3215378|Superiority or Other|||||||0.37||||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).|
1750059|NCT00352053|3215379|Superiority or Other|||||||0.58||||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).||Null hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).|
1750060|NCT00352053|3215380|Superiority or Other|||||||0.4||||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline GSS (without tenofovir DF) <= or > median (median GSS is 2).||Null hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 48 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).|
1750061|NCT00352053|3215381|Superiority or Other|||||||0.55||||||No adjustments for multiple comparisons were made.|Van Elteren test|P-value is from a Van Elteren test stratified by baseline genotypic sensitivity score (GSS) (without tenofovir DF) <= or > median (median GSS is 2).||Null hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are equal. Alternative hypothesis: Time-weighted average changes from baseline through Week 24 in plasma HIV-1 RNA for the tenofovir DF and placebo groups are different (two-sided).|
1750063|NCT00352027|3215383|Superiority or Other (legacy)|||||||0.2199|||||||Cox Model||||
1750064|NCT00352027|3215384|Superiority or Other (legacy)|||||||0.4318|||||||Cox Model||||
1750065|NCT00352027|3215386|Superiority or Other (legacy)|||||||0.411|||||||Log Rank||||
1750066|NCT00352027|3215387|Superiority or Other (legacy)|||||||0.178|||||||Log Rank||||
1750067|NCT00352027|3215388|Superiority or Other (legacy)|||||||0.908|||||||Log Rank||||
1750068|NCT00352027|3215389|Superiority or Other (legacy)||||||<|0.001|||||||Generalized Estimating Equations (GEE)||||
1750069|NCT00352027|3215390|Superiority or Other (legacy)||||||<|0.001|||||||Generalized Estimating Equations (GEE)||||
1750070|NCT00352027|3215391|Superiority or Other (legacy)||||||<|0.001|||||||Generalized Estimating Equations (GEE)||||
1750071|NCT00352027|3215392|Superiority or Other (legacy)||||||<|0.001|||||||Generalized Estimating Equations (GEE)||||
1750072|NCT00352027|3215393|Superiority or Other (legacy)||||||<|0.001|||||||Generalized Estimating Equations (GEE)||||
1750073|NCT00352027|3215394|Superiority or Other (legacy)|||||||0.005|||||||Generalized Estimating Equations (GEE)||||
1750074|NCT00352027|3215395|Superiority or Other (legacy)||||||<|0.001|||||||Generalized Estimating Equations (GEE)||||
1750075|NCT00352027|3215396|Superiority or Other (legacy)||||||<|0.001|||||||Generalized Estimating Equations (GEE)||||
1750076|NCT00352027|3215397|Superiority or Other (legacy)||||||<|0.001|||||||Generalized Estimating Equations (GEE)||||
1750077|NCT00352027|3215398|Superiority or Other (legacy)||||||<|0.001|||||||Generallized Estimating Equations (GEE)||||
1750078|NCT00352027|3215399|Superiority or Other (legacy)||||||<|0.001|||||||Generallized Estimating Equations (GEE)||||
1750079|NCT00352027|3215400|Superiority or Other (legacy)||||||<|0.001|||||||Generallized Estimating Equations (GEE)||||
1750080|NCT00352027|3215401|Superiority or Other (legacy)||||||<|0.001|||||||Generallized Estimating Equations (GEE)||||
1750081|NCT00352027|3215402|Superiority or Other (legacy)||||||<|0.001|||||||Generallized Estimating Equations (GEE)||||
1750082|NCT00352027|3215403|Superiority or Other (legacy)||||||<|0.001|||||||Generalized Estimating Equations (GEE)||||
1750083|NCT00352027|3215404|Superiority or Other (legacy)|||||||0.122||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750084|NCT00352027|3215404|Superiority or Other (legacy)|||||||0.173||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750085|NCT00352027|3215404|Superiority or Other (legacy)|||||||0.553||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750086|NCT00352027|3215404|Superiority or Other (legacy)|||||||0.814||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750087|NCT00352027|3215405|Superiority or Other (legacy)|||||||0.005||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750088|NCT00352027|3215405|Superiority or Other (legacy)|||||||0.245||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750089|NCT00352027|3215405|Superiority or Other (legacy)|||||||0.005||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750090|NCT00352027|3215405|Superiority or Other (legacy)|||||||0.415||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750091|NCT00352027|3215406|Superiority or Other (legacy)|||||||0.0779||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750092|NCT00352027|3215406|Superiority or Other (legacy)|||||||0.051||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750093|NCT00352027|3215406|Superiority or Other (legacy)|||||||0.933||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750094|NCT00352027|3215406|Superiority or Other (legacy)|||||||0.933||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750095|NCT00352027|3215407|Superiority or Other (legacy)|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750096|NCT00352027|3215407|Superiority or Other (legacy)|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750097|NCT00352027|3215407|Superiority or Other (legacy)|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750098|NCT00352027|3215407|Superiority or Other (legacy)|||||||0.739||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750099|NCT00352027|3215408|Superiority or Other (legacy)|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750100|NCT00352027|3215408|Superiority or Other (legacy)|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750101|NCT00352027|3215408|Superiority or Other (legacy)|||||||0.041||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750102|NCT00352027|3215408|Superiority or Other (legacy)|||||||0.078||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750103|NCT00352027|3215409|Superiority or Other (legacy)|||||||0.088||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750104|NCT00352027|3215409|Superiority or Other (legacy)|||||||0.512||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750105|NCT00352027|3215409|Superiority or Other (legacy)|||||||0.075||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750106|NCT00352027|3215409|Superiority or Other (legacy)|||||||0.744||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750107|NCT00352027|3215410|Superiority or Other (legacy)|||||||0.858||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750108|NCT00352027|3215410|Superiority or Other (legacy)|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750109|NCT00352027|3215410|Superiority or Other (legacy)|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750110|NCT00352027|3215410|Superiority or Other (legacy)|||||||0.629||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750111|NCT00352027|3215411|Superiority or Other (legacy)|||||||0.134||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750112|NCT00352027|3215411|Superiority or Other (legacy)|||||||0.277||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750113|NCT00352027|3215411|Superiority or Other (legacy)|||||||0.006||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750114|NCT00352027|3215411|Superiority or Other (legacy)|||||||0.381||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750115|NCT00352027|3215412|Superiority or Other (legacy)|||||||0.162||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750116|NCT00352027|3215412|Superiority or Other (legacy)|||||||0.162||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750117|NCT00352027|3215412|Superiority or Other (legacy)|||||||0.039||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750118|NCT00352027|3215412|Superiority or Other (legacy)|||||||0.558||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750119|NCT00352027|3215413|Superiority or Other (legacy)|||||||0.372||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750120|NCT00352027|3215413|Superiority or Other (legacy)|||||||0.503||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750121|NCT00352027|3215413|Superiority or Other (legacy)|||||||0.372||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750122|NCT00352027|3215413|Superiority or Other (legacy)|||||||0.242||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750123|NCT00352027|3215413|Superiority or Other (legacy)|||||||0.546||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750124|NCT00352027|3215414|Superiority or Other (legacy)|||||||0.243||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750125|NCT00352027|3215414|Superiority or Other (legacy)|||||||0.027||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750126|NCT00352027|3215414|Superiority or Other (legacy)|||||||0.013||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750127|NCT00352027|3215414|Superiority or Other (legacy)|||||||0.025||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750128|NCT00352027|3215414|Superiority or Other (legacy)|||||||0.042||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750129|NCT00352027|3215415|Superiority or Other (legacy)|||||||0.707||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750130|NCT00352027|3215415|Superiority or Other (legacy)||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750131|NCT00352027|3215415|Superiority or Other (legacy)||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750132|NCT00352027|3215415|Superiority or Other (legacy)||||||<|0.001||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750133|NCT00352027|3215415|Superiority or Other (legacy)||||||<|0.071||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750134|NCT00352027|3215416|Superiority or Other (legacy)|||||||0.588||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750135|NCT00352027|3215416|Superiority or Other (legacy)|||||||0.015||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750136|NCT00352027|3215416|Superiority or Other (legacy)|||||||0.002||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750137|NCT00352027|3215416|Superiority or Other (legacy)|||||||0.01||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750138|NCT00352027|3215416|Superiority or Other (legacy)|||||||0.319||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750139|NCT00352027|3215417|Superiority or Other (legacy)|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750140|NCT00352027|3215417|Superiority or Other (legacy)|||||||0.184||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750608|NCT00343252|3216361|Superiority or Other|||||||0.6||||||P-value is for responder versus non-responder.|Chi-squared||||
1750141|NCT00352027|3215417|Superiority or Other (legacy)|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750142|NCT00352027|3215417|Superiority or Other (legacy)|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750143|NCT00352027|3215417|Superiority or Other (legacy)|||||||0.563||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750144|NCT00352027|3215418|Superiority or Other (legacy)|||||||0.68||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750145|NCT00352027|3215418|Superiority or Other (legacy)|||||||0.025||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750146|NCT00352027|3215418|Superiority or Other (legacy)|||||||0.079||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750147|NCT00352027|3215418|Superiority or Other (legacy)|||||||0.057||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750148|NCT00352027|3215418|Superiority or Other (legacy)|||||||0.265||||||P-values are shown after correction for multiple testing using the False Discovery Rate Method.|Wilcoxon Signed Rank Test||||
1750149|NCT00352027|3215451|Superiority or Other (legacy)|||||||0.997|||||||Cox Model||||
1750150|NCT00352027|3215454|Superiority or Other (legacy)|||||||0.997|||||||Cox Model|||The association of age with EFS was compared. P values from Score test were computed for the statistical significance.|
1750151|NCT00351936|3215463|Superiority or Other|||||||0.001|||||||ANCOVA||||
1750152|NCT00351936|3215464|Superiority or Other|||||||0.999|||||||ANCOVA||||
1750153|NCT00351936|3215465|Superiority or Other|||||||0.665|||||||ANCOVA||||
1750154|NCT00351936|3215466|Superiority or Other|||||||0.208|||||||ANCOVA||||
1750155|NCT00351936|3215467|Superiority or Other|||||||0.747|||||||ANCOVA||||
1750156|NCT00351936|3215468|Superiority or Other|||||||0.003|||||||ANCOVA||||
1750157|NCT00351936|3215469|Superiority or Other|||||||0.003|||||||ANCOVA||||
1750158|NCT00351533|3215499|Superiority or Other|||||||0.34|||||||Wilcoxon (Mann-Whitney)||||
1750159|NCT00351533|3215500|Superiority or Other|||||||0.89|||||||Wilcoxon (Mann-Whitney)||||
1750160|NCT00351533|3215501|Superiority or Other|||||||0.86|||||||Wilcoxon (Mann-Whitney)||||
1750161|NCT00351533|3215502|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1750162|NCT00351533|3215503|Superiority or Other|||||||0.71|||||||Wilcoxon (Mann-Whitney)||||
1750163|NCT00351533|3215504|Superiority or Other|||||||0.84|||||||Wilcoxon (Mann-Whitney)||||
1750164|NCT00351533|3215505|Superiority or Other|||||||0.74|||||||Wilcoxon (Mann-Whitney)||||
1750165|NCT00351533|3215506|Superiority or Other|||||||0.84|||||||Wilcoxon (Mann-Whitney)||||
1750166|NCT00351533|3215507|Superiority or Other|||||||0.38|||||||Wilcoxon (Mann-Whitney)||||
1750167|NCT00351533|3215508|Superiority or Other|||||||0.55|||||||Wilcoxon (Mann-Whitney)||||
1750168|NCT00351533|3215509|Superiority or Other|||||||0.49|||||||Chi-squared||||
1750169|NCT00351533|3215510|Superiority or Other|||||||0.65|||||||Chi-squared||||
1750170|NCT00351533|3215511|Superiority or Other|||||||0.27|||||||t-test, 2 sided||||
1750171|NCT00351533|3215512|Superiority or Other|||||||0.66|||||||t-test, 2 sided||||
1750172|NCT00351533|3215513|Superiority or Other|||||||0.69|||||||t-test, 2 sided||||
1750173|NCT00351533|3215514|Superiority or Other|||||||0.56|||||||t-test, 2 sided||||
1750174|NCT00351533|3215515|Superiority or Other|||||||0.11|||||||Wilcoxon (Mann-Whitney)||||
1750175|NCT00351533|3215516|Superiority or Other|||||||0.2|||||||Wilcoxon (Mann-Whitney)||||
1750176|NCT00351533|3215517|Superiority or Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1750177|NCT00351533|3215518|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1750178|NCT00351533|3215519|Superiority or Other|||||||0.89|||||||Wilcoxon (Mann-Whitney)||||
1750179|NCT00351533|3215520|Superiority or Other|||||||0.06|||||||t-test, 2 sided||||
1750180|NCT00351533|3215521|Superiority or Other|||||||0.26|||||||t-test, 2 sided||||
1750181|NCT00351533|3215522|Superiority or Other|||||||0.34|||||||Wilcoxon (Mann-Whitney)||||
1750182|NCT00351533|3215523|Superiority or Other|||||||0.79|||||||Wilcoxon (Mann-Whitney)||||
1750183|NCT00351533|3215524|Superiority or Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)||||
1750184|NCT00351533|3215525|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)||||
1750185|NCT00351533|3215526|Superiority or Other|||||||0.37|||||||Wilcoxon (Mann-Whitney)||||
1750186|NCT00351273|3215561|Superiority or Other||Mean Difference (Final Values)|40.8||||0.01|2-Sided||||||Fisher Exact|||Difference in the percentages of participants with response between all those who received combination therapy vs. placebo|
1750187|NCT00351000|3215568|Superiority or Other|||||||0.988|||||||t-test, 2 sided||||
1750188|NCT00351000|3215569|Superiority or Other|||||||0.956|||||||t-test, 2 sided||||
1750189|NCT00350779|3215579|Superiority or Other||Mean Difference (Net)|-34.1|Standard Deviation|51.0|<|0.001||95.0|-48.4|-19.9|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy|||
1750190|NCT00350779|3215580|Superiority or Other||Mean Difference (Net)|-17.4|Standard Deviation|34.6|<|0.001||95.0|-26.4|-8.4|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy|||
1750191|NCT00350779|3215581|Superiority or Other||Mean Difference (Net)|-0.77|Standard Deviation|1.04|<|0.001||95.0|-1.04|-0.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy|||
1750192|NCT00350779|3215582|Superiority or Other||Mean Difference (Net)|-37.9|Standard Deviation|43.7|<|0.001||95.0|-50.2|-25.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy|||
1750193|NCT00350779|3215583|Superiority or Other||Mean Difference (Net)|-19.0|Standard Deviation|31.3|<|0.001||95.0|-27.2|-10.9|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy|||
1750194|NCT00350779|3215584|Superiority or Other||Mean Difference (Net)|-0.72|Standard Deviation|0.87|<|0.001||95.0|-0.95|-0.49|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy|||
1750195|NCT00350402|3215642|Superiority or Other||Mean Difference (Final Values)|5.129|Standard Error of the Mean|2.492|<|0.047|2-Sided|95.0|0.0834|10.17||No adjustment necessary|t-test, 2 sided|38 df, t= 2.058 However, due to inequality of variance (Levine test), the adjusted p-value = <0.049, and adjusted df = 27.3||Hypothesis: Facial entropy changes would be greater in IMST group than sham treatment group. Sample size was based on preliminary data suggesting total N of 40 would be adequate for detecting change in entropy (of approximately 50%).|
1750196|NCT00350402|3215643|Superiority or Other||Mean Difference (Final Values)|10.426|Standard Error of the Mean|4.221|<|0.018|2-Sided|95.0|1.874|18.978|||t-test, 2 sided|t-value = 2.47, with 37 df||Hypothesis: Changes in MIP following treatment would be greater for participants in the IMST versus the Sham treatment group. This is a validity check on for the IMST intervention.|
1750197|NCT00350402|3215644|Superiority or Other||Mean Difference (Final Values)|-6.36|Standard Error of the Mean|4.955|<|0.459|2-Sided|95.0|-16.41|3.68|||t-test, 2 sided|||Hypothesis: Scores on PDQ-39 would show bigger change for the IMST group than the Sham treatment group. The sample size was not powered for the PDQ-39 (but rather for the primary outcome variable).|
1750198|NCT00350402|3215645|Superiority or Other||Mean Difference (Final Values)|7.254|Standard Error of the Mean|2.028|<|0.001|2-Sided|95.0|3.147|11.362|||t-test, 2 sided|df = 38; t = 3.576|Treatment effect size: Cohen's D =1.142|Hypothesis: Parkinson patients assigned to high intensity IMST will show greater improvement in facial movement (entropy) relative to those undergoing Sham IMST.|
1750199|NCT00350272|3215659|Superiority or Other||Risk Difference (RD)|-13.5|||||2-Sided|95.0|-35.2|8.2||||||Difference in proportions between the group of subjects who received lamivudine 300 m/day (in combination with efavirenz and tenofovir) over 12 weeks and the group of subjects who received elvucitabine 10.mg/day (in combination with efavirenz and tenofovir) over 12 weeks along with corresponding 2-sided 95% confidence interval for risk difference using asymptotic normal theory.|
1750200|NCT00350142|3215732|Superiority or Other||proportion|0.75|||||2-Sided||||||||||
1750201|NCT00349921|3215738|Superiority or Other||||||>|0.05|||||||Chi-squared|||Null hypothesis is that there is no difference between the groups in proportion of patients meeting the success criterion of >30% reduction in visual analog scale pain 120 min after intrathecal injection|
1750202|NCT00349466|3215775|Superiority or Other (legacy)|||||||0.006|||||||Fisher Exact||||
1750203|NCT00349349|3215802|Superiority or Other||percentage of responders|0.63|||<|0.001|2-Sided|95.3|0.35|0.85||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two-sided 95.3% exact confidence intervals were calculated based on the binomial distribution.||
1750204|NCT00349349|3215802|Superiority or Other||percentage of responders|0.43|||<|0.0001|2-Sided|95.3|0.33|0.53||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two sided 95.3% exact confidence intervals were calculated based on the binomial distribution.||
1750205|NCT00349349|3215802|Superiority or Other||percentage of responders|0.49|||<|0.0001|2-Sided|95.3|0.39|0.6||The p value is testing the hypothesis that the response rate is equal to 15% versus the response rate is not equal to 15%.|Two-sided exact binomial test||Two-sided 95.3% exact confidence intervals were calculated based on the binomial distribution.||
1750206|NCT00348309|3215874|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.797|2-Sided|95.0|-0.9|0.7||Week 48|Mixed Models Analysis||||
1750207|NCT00348309|3215874|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.03|2-Sided|95.0|-1.6|-0.1||Week 48|Mixed Models Analysis||||
1750208|NCT00348309|3215874|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.318|2-Sided|95.0|-1.1|0.4||Week 36|Mixed Models Analysis||||
1750209|NCT00348309|3215874|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.268|2-Sided|95.0|-1.1|0.3||Week 36|Mixed Models Analysis||||
1750210|NCT00348309|3215874|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.091|2-Sided|95.0|-1.1|0.1||Week 12|Mixed Models Analysis||||
1750211|NCT00348309|3215874|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.027|2-Sided|95.0|-1.2|-0.1||Week 12|Mixed Models Analysis||||
1750212|NCT00348309|3215884|Superiority or Other||Mean Difference (Final Values)|0.04||||0.14|2-Sided|95.0|-0.01|0.09|||ANCOVA||||
1750213|NCT00348309|3215884|Superiority or Other||Mean Difference (Final Values)|0.07||||0.006|2-Sided|95.0|0.02|0.12|||ANCOVA||||
1750214|NCT00348309|3215885|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.073|2-Sided|95.0|-0.4|0.0|||ANCOVA||||
1750215|NCT00348309|3215885|Superiority or Other||Mean Difference (Final Values)|0.0||||0.598|2-Sided|95.0|-0.2|0.1|||ANCOVA||||
1750216|NCT00348309|3215886|Superiority or Other||Mean Difference (Final Values)|0.4||||0.297|2-Sided|95.0|-0.3|1.1|||ANCOVA||||
1750217|NCT00348309|3215886|Superiority or Other||Mean Difference (Final Values)|0.4||||0.292|2-Sided|95.0|-0.3|1.1|||ANCOVA||||
1750218|NCT00348309|3215887|Superiority or Other||Mean Difference (Final Values)|0.1||||0.554|2-Sided|95.0|-0.3|0.5|||ANCOVA||||
1750219|NCT00348309|3215887|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.004|2-Sided|95.0|-0.9|-0.2|||ANCOVA||||
1750220|NCT00348309|3215888|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.483|2-Sided|95.0|-1.3|0.6|||ANCOVA||||
1750221|NCT00348309|3215888|Superiority or Other||Mean Difference (Final Values)|-0.7||||0.105|2-Sided|95.0|-1.6|0.2|||ANCOVA||||
1750222|NCT00348309|3215889|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.64|2-Sided|95.0|-0.04|0.03||Week 48 Utility|Mixed Models Analysis||||
1750223|NCT00348309|3215889|Superiority or Other||Mean Difference (Final Values)|0.03||||0.077|2-Sided|95.0|0.0|0.06||Week 48 Utility|Mixed Models Analysis||||
1750224|NCT00348309|3215889|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.081|2-Sided|95.0|-0.06|0.0||Week 36 Utility|Mixed Models Analysis||||
1750225|NCT00348309|3215889|Superiority or Other||Mean Difference (Final Values)|0.01||||0.498|2-Sided|95.0|-0.02|0.04||Week 36 Utility|Mixed Models Analysis||||
1750226|NCT00348309|3215889|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.18|2-Sided|95.0|-0.04|0.01||Week 12 Utility|Mixed Models Analysis||||
1750227|NCT00348309|3215889|Superiority or Other||Mean Difference (Final Values)|0.01||||0.32|2-Sided|95.0|-0.01|0.03||Week 12 Utility|Mixed Models Analysis||||
1750228|NCT00348309|3215889|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.557|2-Sided|95.0|-3.7|2.0||Week 48 Thermometer|Mixed Models Analysis||||
1750229|NCT00348309|3215889|Superiority or Other||Mean Difference (Final Values)|1.2||||0.392|2-Sided|95.0|-1.5|3.8||Week 48 Thermometer|Mixed Models Analysis||||
1750230|NCT00348309|3215889|Superiority or Other||Mean Difference (Final Values)|-2.9||||0.03|2-Sided|95.0|-5.6|-0.3||Week 36 Thermometer|Mixed Models Analysis||||
1750231|NCT00348309|3215889|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.063|2-Sided|95.0|-4.9|0.1||Week 36 Thermometer|Mixed Models Analysis||||
1750232|NCT00348309|3215889|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.415|2-Sided|95.0|-3.3|1.4||Week 12 Thermometer|Mixed Models Analysis||||
1750233|NCT00348309|3215889|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.914|2-Sided|95.0|-2.3|2.0||Week 12 Thermometer|Mixed Models Analysis||||
1750234|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|16.2||||0.046|2-Sided|95.0|0.3|32.0||Week 48 Q2|Mixed Models Analysis||||
1750235|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|-2.4||||0.735|2-Sided|95.0|-16.2|11.4||Week 48 Q2|Mixed Models Analysis||||
1750236|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|8.3||||0.253|2-Sided|95.0|-6.0|22.6||Week 36 Q2|Mixed Models Analysis||||
1750237|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.949|2-Sided|95.0|-13.3|12.5||Week 36 Q2|Mixed Models Analysis||||
1750238|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|6.1||||0.351|2-Sided|95.0|-6.8|19.1||Week 24 Q2|Mixed Models Analysis||||
1750239|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|1.3||||0.832|2-Sided|95.0|-10.5|13.1||Week 24 Q2|Mixed Models Analysis||||
1750240|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|7.9||||0.194|2-Sided|95.0|-4.0|19.9||Week 12 Q2|Mixed Models Analysis||||
1750241|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|8.8||||0.129|2-Sided|95.0|-2.6|20.2||Week 12 Q2|Mixed Models Analysis||||
1750242|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|-3.6||||0.562|2-Sided|95.0|-15.7|8.6||Week 48 Q1|Mixed Models Analysis||||
1750243|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|-4.6||||0.422|2-Sided|95.0|-15.9|6.7||Week 48 Q1|Mixed Models Analysis||||
1750244|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.857|2-Sided|95.0|-12.9|10.7||Week 36 Q1|Mixed Models Analysis||||
1750245|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|-6.2||||0.195|2-Sided|95.0|-15.6|3.2||Week 36 Q1|Mixed Models Analysis||||
1750246|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|-3.7||||0.481|2-Sided|95.0|-14.0|6.6||Week 24 Q1|Mixed Models Analysis||||
1750247|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|-7.3||||0.052|2-Sided|95.0|-14.7|0.1||Week 24 Q1|Mixed Models Analysis||||
1750248|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.643|2-Sided|95.0|-9.0|5.6||Week 12Q1|Mixed Models Analysis||||
1750249|NCT00348309|3215890|Superiority or Other||Mean Difference (Final Values)|0.8||||0.789|2-Sided|95.0|-5.2|6.9|||Mixed Models Analysis|||Week 12 Q1|
1750250|NCT00348309|3215891|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.617|2-Sided|95.0|-0.7|0.4|||ANCOVA||||
1750251|NCT00348309|3215891|Superiority or Other||Mean Difference (Final Values)|0.0||||0.87|2-Sided|95.0|-0.5|0.6|||ANCOVA||||
1750252|NCT00348309|3215892|Superiority or Other||Mean Difference (Final Values)|0.2||||0.814|2-Sided|95.0|-1.4|1.8||Week 48|Mixed Models Analysis||||
1750253|NCT00348309|3215892|Superiority or Other||Mean Difference (Final Values)|-1.5||||0.043|2-Sided|95.0|-2.9|0.0||Week 48|Mixed Models Analysis||||
1750254|NCT00348309|3215892|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.732|2-Sided|95.0|-1.5|1.0||Week 24|Mixed Models Analysis||||
1750255|NCT00348309|3215892|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.264|2-Sided|95.0|-1.8|0.5||Week 24|Mixed Models Analysis||||
1750256|NCT00348309|3215892|Superiority or Other||Mean Difference (Final Values)|0.3||||0.55|2-Sided|95.0|-0.8|1.5||Week 16|Mixed Models Analysis||||
1750257|NCT00348309|3215892|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.485|2-Sided|95.0|-1.4|0.7||Week 16|Mixed Models Analysis||||
1750258|NCT00348309|3215892|Superiority or Other||Mean Difference (Final Values)|0.0||||0.931|2-Sided|95.0|-1.0|1.1||Week 8|Mixed Models Analysis||||
1750259|NCT00348309|3215892|Superiority or Other||Mean Difference (Final Values)|-0.4|||=|0|2-Sided|95.0|-1.3|0.5||Week 8|Mixed Models Analysis||||
1750260|NCT00348309|3215893|Superiority or Other||Mean Difference (Final Values)|-0.7|||=|0|2-Sided|95.0|-2.9|1.6||Week 48|Mixed Models Analysis||||
1750261|NCT00348309|3215893|Superiority or Other||Mean Difference (Final Values)|2.1|||=|0.061|2-Sided|95.0|-0.1|4.2||Week 48|Mixed Models Analysis||||
1750262|NCT00348309|3215893|Superiority or Other||Mean Difference (Final Values)|0.2|||=|0|2-Sided|95.0|-1.6|2.0||Week 24|Mixed Models Analysis||||
1750263|NCT00348309|3215893|Superiority or Other||Mean Difference (Final Values)|1.3|||=|0|2-Sided|95.0|-0.5|3.0||Week 24|Mixed Models Analysis||||
1750264|NCT00348309|3215893|Superiority or Other||Mean Difference (Final Values)|-0.5|||=|0.521|2-Sided|95.0|-2.1|1.0||Week 16|Mixed Models Analysis||||
1750265|NCT00348309|3215893|Superiority or Other||Mean Difference (Final Values)|-0.1|||=|0|2-Sided|95.0|-1.7|1.5||Week 16|Mixed Models Analysis||||
1750266|NCT00348309|3215893|Superiority or Other||Mean Difference (Final Values)|-1.2|||=|0|2-Sided|95.0|-2.5|0.1||Week 8|Mixed Models Analysis||||
1750267|NCT00348309|3215893|Superiority or Other||Mean Difference (Final Values)|-0.6|||=|0|2-Sided|95.0|-2.0|0.7||Week 8|Mixed Models Analysis||||
1751292|NCT00329433|3217476|Superiority||||||<|0.05|||||||Fisher Exact||||
1750268|NCT00348309|3215894|Superiority or Other||Mean Difference (Final Values)|0.1|||=|0|2-Sided|95.0|-0.2|0.5||Full population|Mixed Models Analysis||||
1750269|NCT00348309|3215894|Superiority or Other||Mean Difference (Final Values)|-0.5|||=|0|2-Sided|95.0|-0.9|-0.2||Full population|Mixed Models Analysis||||
1750270|NCT00348309|3215894|Superiority or Other||Mean Difference (Final Values)|0.2|||=|0|2-Sided|95.0|-0.2|0.6||All except E4/E4s|Mixed Models Analysis||||
1750271|NCT00348309|3215894|Superiority or Other||Mean Difference (Final Values)|-0.5|||=|0|2-Sided|95.0|-0.9|-0.2||All except E4/E4s|Mixed Models Analysis||||
1750272|NCT00348309|3215894|Superiority or Other||Mean Difference (Final Values)|0.2|||=|0|2-Sided|95.0|-0.4|0.7||APOE4 negatives|Mixed Models Analysis||||
1750273|NCT00348309|3215894|Superiority or Other||Mean Difference (Final Values)|-0.5|||=|0|2-Sided|95.0|-1.0|0.0||APOE4 negatives|Mixed Models Analysis||||
1750274|NCT00348309|3215895|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.661|2-Sided|95.0|-1.2|0.7||Full population|Mixed Models Analysis||||
1750275|NCT00348309|3215895|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.02|2-Sided|95.0|-1.9|-0.2||Full population|Mixed Models Analysis||||
1750276|NCT00348309|3215895|Superiority or Other||Mean Difference (Final Values)|0.0||||0.999|2-Sided|95.0|-1.0|1.0||All except E4/E4s|Mixed Models Analysis||||
1750277|NCT00348309|3215895|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.035|2-Sided|95.0|-1.9|-0.1||All except E4/E4s|Mixed Models Analysis||||
1750278|NCT00348309|3215895|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.808|2-Sided|95.0|-1.7|1.3||APOE4 negatives|Mixed Models Analysis||||
1750279|NCT00348309|3215895|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.049|2-Sided|95.0|-2.7|0.0||APOE4 negatives|Mixed Models Analysis||||
1750280|NCT00348283|3215896|Superiority or Other||||||<|0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 12 in the two treatment groups.|
1750281|NCT00348283|3215897|Superiority or Other|||||||0.15||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference between proportions of subjects without mucosal ulceration at both Week 12 and Week 52 in the two treatment groups.|
1750282|NCT00348283|3215898|Superiority or Other|||||||0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 52 in the two treatment groups.|
1750283|NCT00348283|3215899|Superiority or Other||||||<|0.001||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference between proportions of subjects without mucosal ulceration at Week 52 in the two treatment groups.|
1750284|NCT00348283|3215900|Superiority or Other|||||||0.021||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|||The null hypothesis was that there is no difference in proportion of subjects with clinical remission at Week 12 in the two treatment groups.|
1750285|NCT00348283|3215901|Superiority or Other|||||||0.056||||||The P value is from Cochran-Mantel-Haenszel test with clinical response (CR-70 responder status) at Week 4 as the stratification factor.|Cochran-Mantel-Haenszel|Because of the hierarchical testing scheme used for testing the ranked secondary endpoints, alpha level of 0.05 was used at each stage of testing.||ITT population: all subjects randomized at Week 4 who had at least 1 dose of blinded therapy. The sample-size (placebo = 65 subjects; adalimumab = 65 subjects) for the primary efficacy analysis was calculated using 88% power at 0.05 alpha level based on the assumption that 25% and 5% of subjects were without mucosal ulceration at Week 12 in adalimumab 40 mg eow and placebo groups, respectively. However, subjects without mucosal ulceration at Screening were excluded from the primary analysis.|
1750286|NCT00348140|3215902|Superiority||Mean Difference (Net)|0.3||||0.149|2-Sided|95.0|-0.1|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48|
1750287|NCT00348140|3215902|Superiority||Mean Difference (Net)|0.0||||0.865|2-Sided|95.0|-0.5|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48|
1750288|NCT00348140|3215902|Superiority||Mean Difference (Net)|0.1||||0.608|2-Sided|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36|
1750289|NCT00348140|3215902|Superiority||Mean Difference (Net)|0.1||||0.626|2-Sided|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36|
1750290|NCT00348140|3215902|Superiority||Mean Difference (Net)|0.3||||0.178|2-Sided|95.0|-0.1|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24|
1750291|NCT00348140|3215902|Superiority||Mean Difference (Net)|0.0||||0.928|2-Sided|95.0|-0.4|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24|
1750292|NCT00348140|3215902|Superiority||Mean Difference (Net)|-0.2||||0.4|2-Sided|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 16|
1750293|NCT00348140|3215902|Superiority||Mean Difference (Net)|-0.1||||0.708|2-Sided|95.0|-0.5|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 16|
1750294|NCT00348140|3215902|Superiority||Mean Difference (Net)|0.1||||0.617|2-Sided|95.0|-0.3|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8|
1750295|NCT00348140|3215902|Superiority||Mean Difference (Net)|-0.1||||0.748|2-Sided|95.0|-0.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8|
1750296|NCT00348140|3215915|Superiority||Mean Difference (Net)|0.13|||<|0.001|2-Sided|95.0|0.08|0.18|||ANCOVA||||
1750297|NCT00348140|3215915|Superiority||Mean Difference (Net)|0.05|||<|0.038|2-Sided|95.0|0.0|0.1|||ANCOVA||||
1750298|NCT00348140|3215916|Superiority||Mean Difference (Net)|0.0||||0.987|2-Sided|95.0|-0.2|0.2|||ANCOVA||||
1750299|NCT00348140|3215916|Superiority||Mean Difference (Net)|-0.1||||0.324|2-Sided|95.0|-0.3|0.1|||ANCOVA||||
1750300|NCT00348140|3215917|Superiority||Mean Difference (Net)|-0.4||||0.229|2-Sided|95.0|-1.2|0.3|||ANCOVA||||
1750301|NCT00348140|3215917|Superiority||Mean Difference (Net)|-0.6||||0.106|2-Sided|95.0|-1.3|0.1|||ANCOVA||||
1750302|NCT00348140|3215918|Superiority||Mean Difference (Net)|0.1||||0.78|2-Sided|95.0|-0.6|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48|
1750303|NCT00348140|3215918|Superiority||Mean Difference (Net)|0.2||||0.549|2-Sided|95.0|-0.5|1.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 48|
1750304|NCT00348140|3215918|Superiority||Mean Difference (Net)|0.2||||0.488|2-Sided|95.0|-0.4|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 36|
1750305|NCT00348140|3215918|Superiority||Mean Difference (Net)|-0.4||||0.284|2-Sided|95.0|-1.0|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 36|
1750306|NCT00348140|3215918|Superiority||Mean Difference (Net)|-0.1||||0.62|2-Sided|95.0|-0.7|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 12|
1750307|NCT00348140|3215918|Superiority||Mean Difference (Net)|-0.2||||0.529|2-Sided|95.0|-0.7|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Week 12|
1750308|NCT00348140|3215919|Superiority||Mean Difference (Net)|0.0||||0.769|2-Sided|95.0|-0.03|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 48|
1750309|NCT00348140|3215919|Superiority||Mean Difference (Net)|-0.01||||0.366|2-Sided|95.0|-0.05|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 48|
1750310|NCT00348140|3215919|Superiority||Mean Difference (Net)|-0.03||||0.083|2-Sided|95.0|-0.05|0.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 36|
1750311|NCT00348140|3215919|Superiority||Mean Difference (Net)|0.0||||0.892|2-Sided|95.0|-0.03|0.03|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Utility score Week 36|
1750312|NCT00348140|3215919|Superiority||Mean Difference (Net)|-0.01||||0.503|2-Sided|95.0|-0.03|0.02|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Ultility score Week 12|
1750313|NCT00348140|3215919|Superiority||Mean Difference (Net)|0.01||||0.662|2-Sided|95.0|-0.02|0.03|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Ultility score Week 12|
1750492|NCT00346216|3216042|Superiority or Other||Hazard Ratio (HR)|0.82||||0.0204|2-Sided|95.0|0.69|0.97|||Regression, Cox|||MITT Population|
1750314|NCT00348140|3215920|Superiority||Mean Difference (Net)|-3.4||||0.009|2-Sided|95.0|-6.0|-0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 48|
1750315|NCT00348140|3215920|Superiority||Mean Difference (Net)|-2.6||||0.05|2-Sided|95.0|-5.2|0.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 48|
1750316|NCT00348140|3215920|Superiority||Mean Difference (Net)|-2.0||||0.109|2-Sided|95.0|-4.5|0.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 36|
1750317|NCT00348140|3215920|Superiority||Mean Difference (Net)|-0.4||||0.758|2-Sided|95.0|-2.8|2.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 36|
1750318|NCT00348140|3215920|Superiority||Mean Difference (Net)|-2.2||||0.056|2-Sided|95.0|-4.5|0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 12|
1750319|NCT00348140|3215920|Superiority||Mean Difference (Net)|-2.4||||0.043|2-Sided|95.0|-4.7|-0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Thermometer score Week 12|
1750320|NCT00348140|3215921|Superiority||Mean Difference (Net)|-0.2||||0.975|2-Sided|95.0|-14.7|14.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 48|
1750321|NCT00348140|3215921|Superiority||Mean Difference (Net)|4.2||||0.596|2-Sided|95.0|-11.3|19.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 48|
1750322|NCT00348140|3215921|Superiority||Mean Difference (Net)|-1.2||||0.865|2-Sided|95.0|-15.0|12.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 36|
1750323|NCT00348140|3215921|Superiority||Mean Difference (Net)|7.0||||0.389|2-Sided|95.0|-8.9|22.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 36|
1750324|NCT00348140|3215921|Superiority||Mean Difference (Net)|6.8||||0.291|2-Sided|95.0|-5.8|19.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 24|
1750325|NCT00348140|3215921|Superiority||Mean Difference (Net)|10.0||||0.121|2-Sided|95.0|-2.6|22.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 24|
1750326|NCT00348140|3215921|Superiority||Mean Difference (Net)|7.4||||0.183|2-Sided|95.0|-3.5|18.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 12|
1750327|NCT00348140|3215921|Superiority||Mean Difference (Net)|6.8||||0.197|2-Sided|95.0|-3.6|17.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q2 Week 12|
1750328|NCT00348140|3215921|Superiority||Mean Difference (Net)|3.4||||0.572|2-Sided|95.0|-8.5|15.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 48|
1750329|NCT00348140|3215921|Superiority||Mean Difference (Net)|4.0||||0.484|2-Sided|95.0|-7.2|15.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 48|
1750330|NCT00348140|3215921|Superiority||Mean Difference (Net)|2.2||||0.711|2-Sided|95.0|-9.4|13.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 36|
1750331|NCT00348140|3215921|Superiority||Mean Difference (Net)|1.5||||0.785|2-Sided|95.0|-9.5|12.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 36|
1750332|NCT00348140|3215921|Superiority||Mean Difference (Net)|3.5||||0.482|2-Sided|95.0|-6.3|13.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 24|
1750333|NCT00348140|3215921|Superiority||Mean Difference (Net)|1.6||||0.723|2-Sided|95.0|-7.1|10.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 24|
1750334|NCT00348140|3215921|Superiority||Mean Difference (Net)|5.9||||0.113|2-Sided|95.0|-1.4|13.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 12|
1750335|NCT00348140|3215921|Superiority||Mean Difference (Net)|4.1||||0.251|2-Sided|95.0|-2.9|11.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|Q1 Week 12|
1750336|NCT00348140|3215922|Superiority||Mean Difference (Net)|-0.7||||0.331|2-Sided|95.0|-2.1|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48|
1750337|NCT00348140|3215922|Superiority||Mean Difference (Net)|-1.0||||0.141|2-Sided|95.0|-2.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48|
1750338|NCT00348140|3215922|Superiority||Mean Difference (Net)|-1.0||||0.074|2-Sided|95.0|-2.1|0.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24|
1750339|NCT00348140|3215922|Superiority||Mean Difference (Net)|-0.9||||0.117|2-Sided|95.0|-2.1|0.2|||Mixed model for repeated measures|||For Week 24|
1750340|NCT00348140|3215922|Superiority||Mean Difference (Net)|0.0||||0.952|2-Sided|95.0|-0.9|1.0|||Mixed model for repeated measures|||For Week 16|
1750341|NCT00348140|3215922|Superiority||Mean Difference (Net)|0.1||||0.812|2-Sided|95.0|-0.8|1.1|||Mixed model for repeated measures|||For Week 16|
1750342|NCT00348140|3215922|Superiority||Mean Difference (Net)|-0.2||||0.631|2-Sided|95.0|-1.1|0.6|||Mixed model for repeated measures|||For Week 8|
1750343|NCT00348140|3215922|Superiority||Mean Difference (Net)|-0.2||||0.583|2-Sided|95.0|-1.1|0.6|||Mixed model for repeated measures|||For Week 8|
1750344|NCT00348140|3215923|Superiority||Mean Difference (Net)|-0.9||||0.43|2-Sided|95.0|-3.2|1.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48|
1750345|NCT00348140|3215923|Superiority||Mean Difference (Net)|0.1||||0.914|2-Sided|95.0|-2.1|2.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 48|
1750346|NCT00348140|3215923|Superiority||Mean Difference (Net)|-0.1||||0.895|2-Sided|95.0|-1.8|1.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24|
1750347|NCT00348140|3215923|Superiority||Mean Difference (Net)|1.7||||0.039|2-Sided|95.0|0.1|3.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24|
1750348|NCT00348140|3215923|Superiority||Mean Difference (Net)|-0.9||||0.275|2-Sided|95.0|-2.5|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16|
1750349|NCT00348140|3215923|Superiority||Mean Difference (Net)|0.7||||0.395|2-Sided|95.0|-0.9|2.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16|
1750350|NCT00348140|3215923|Superiority||Mean Difference (Net)|0.0||||0.957|2-Sided|95.0|-1.3|1.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8|
1750351|NCT00348140|3215923|Superiority||Mean Difference (Net)|1.1||||0.09|2-Sided|95.0|-0.2|2.5|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8|
1750352|NCT00348140|3215924|Superiority||Mean Difference (Net)|0.0||||0.999|2-Sided|95.0|-0.6|0.6|||ANCOVA||||
1750353|NCT00348140|3215924|Superiority||Mean Difference (Net)|-0.3||||0.386|2-Sided|95.0|-0.8|0.3|||ANCOVA||||
1750423|NCT00346268|3216038|Superiority or Other||least square (LS) mean difference (net)|-15.16|Standard Error of the Mean|5.2||0.004|2-Sided|95.0|-25.47|-4.85||Adjusted for treatment group and center|ANOVA||||
1750354|NCT00348140|3215925|Superiority||Mean Difference (Net)|-0.1||||0.429|2-Sided|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36|
1750355|NCT00348140|3215925|Superiority||Mean Difference (Net)|-0.1||||0.452|2-Sided|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36|
1750356|NCT00348140|3215925|Superiority||Mean Difference (Net)|0.1||||0.596|2-Sided|95.0|-0.2|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24|
1750357|NCT00348140|3215925|Superiority||Mean Difference (Net)|-0.1||||0.465|2-Sided|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24|
1750358|NCT00348140|3215925|Superiority||Mean Difference (Net)|0.0||||0.887|2-Sided|95.0|-0.2|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 12|
1750359|NCT00348140|3215925|Superiority||Mean Difference (Net)|0.0||||0.938|2-Sided|95.0|-0.2|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 12|
1750360|NCT00348140|3215926|Superiority||Mean Difference (Net)|-0.1||||0.849|2-Sided|95.0|-0.9|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36|
1750361|NCT00348140|3215926|Superiority||Mean Difference (Net)|0.2||||0.691|2-Sided|95.0|-0.6|1.0|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 36|
1750362|NCT00348140|3215926|Superiority||Mean Difference (Net)|0.0||||0.978|2-Sided|95.0|-0.7|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24|
1750363|NCT00348140|3215926|Superiority||Mean Difference (Net)|0.4||||0.292|2-Sided|95.0|-0.3|1.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 24|
1750364|NCT00348140|3215926|Superiority||Mean Difference (Net)|0.0||||0.908|2-Sided|95.0|-0.7|0.6|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16|
1750365|NCT00348140|3215926|Superiority||Mean Difference (Net)|0.1||||0.82|2-Sided|95.0|-0.6|0.7|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 16|
1750366|NCT00348140|3215926|Superiority||Mean Difference (Net)|0.2||||0.575|2-Sided|95.0|-0.4|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8|
1750367|NCT00348140|3215926|Superiority||Mean Difference (Net)|0.1||||0.633|2-Sided|95.0|-0.5|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data|For Week 8|
1750368|NCT00348140|3215927|Superiority||Mean Difference (Net)|-0.1||||0.404|2-Sided|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data||
1750369|NCT00348140|3215927|Superiority||Mean Difference (Net)|-0.1||||0.557|2-Sided|95.0|-0.4|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data||
1750370|NCT00348140|3215928|Superiority||Mean Difference (Net)|-0.1||||0.481|2-Sided|95.0|-0.5|0.2|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data||
1750371|NCT00348140|3215928|Superiority||Mean Difference (Net)|0.0||||0.913|2-Sided|95.0|-0.4|0.3|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data||
1750491|NCT00346216|3216042|Superiority or Other||Hazard Ratio (HR)|1.17||||0.0751|2-Sided|95.0|0.98|1.38|||Regression, Cox|||MITT Population|
1750372|NCT00348140|3215929|Superiority||Mean Difference (Net)|-0.1||||0.741|2-Sided|95.0|-0.6|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data||
1750373|NCT00348140|3215929|Superiority||Mean Difference (Net)|-0.1||||0.611|2-Sided|95.0|-0.7|0.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data||
1750374|NCT00348140|3215930|Superiority||Mean Difference (Net)|-0.1|||=|0|2-Sided|95.0|-1.1|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data||
1750375|NCT00348140|3215930|Superiority||Mean Difference (Net)|-0.1|||=|0|2-Sided|95.0|-1.1|0.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data||
1750376|NCT00348140|3215931|Superiority||Mean Difference (Net)|0.0||||0.94|2-Sided|95.0|-1.1|1.1|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data||
1750377|NCT00348140|3215931|Superiority||Mean Difference (Net)|-0.1||||0.783|2-Sided|95.0|-1.1|0.9|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data||
1750378|NCT00348140|3215932|Superiority||Mean Difference (Net)|0.8||||0.343|2-Sided|95.0|-0.8|2.4|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data||
1750379|NCT00348140|3215932|Superiority||Mean Difference (Net)|0.3||||0.739|2-Sided|95.0|-1.2|1.8|||Mixed model for repeated measures|Mixed model for repeated measures with restricted maximum likelihood estimation and an unstructured covariance matrix|Difference in adjusted least square means was shown (Active treatment minus Placebo); n = Number of participants with evaluable data||
1750380|NCT00347919|3215945|Superiority or Other|||||||0.7488|||||||Log Rank||||
1750381|NCT00347919|3215946|Superiority or Other||Percentage difference|5.4||||0.2578||90.0|-8.4|19.2|||Chi-squared||Difference in the percentage of investigator-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)||
1750382|NCT00347919|3215946|Superiority or Other||Percentage difference|2.7||||0.3724||90.0|-11.0|16.3|||Chi-squared||Difference in the percentage of independently-evaluated PD between lapatinib and combination therapy (lapatinib plus pazopanib)||
1750383|NCT00347776|3215948|Superiority||Odds Ratio (OR)|0.63|||||2-Sided|95.0|0.36|1.1|||||Comparison group was the tetracycline group.|Surgery was considered a failure if there was trichiasis recurrence at 6 week follow-up.|
1750384|NCT00347776|3215949|Superiority|||||||0.19|||||||Log Rank|||"We tried to evaluate if treating the immediate family members of the subject with oral azithromycin along with the subject had added advantage in reducing the rate of recurrent trichiasis in comparison to treating the subject alone with oral azithromycin post surgery.~The log rank test was done to compare the survival rates between the two intervention arms.The comparison results were expressed in person-years."|
1750385|NCT00347776|3215950|Superiority||Cox Proportional Hazard|0.67||||0.047|2-Sided|95.0|0.45|0.98|||Log Rank|||"The log rank test was done to compare the survival rates between the tetracycline arm and the azithromycin arms combined.~The Cox proportional hazard model was used to evaluate risk factors and adjust for confounding in predicting recurrence."|
1750386|NCT00347360|3215965|Superiority or Other||||||>|0.1|||||||Hung AVE test, see comments|Hung AVE Test Statistic: -0.00485. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.||This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.|
1750387|NCT00347360|3215966|Superiority or Other||||||>|0.1|||||||Hung AVE test, see comments|Hung AVE Test Statistic: -0.41499. Tests an average of the minimum gains (in response) for the 9 combination cells over corresponding monotherapies.||This is an omnibus test to investigate the existence of at least one combination dose that outperforms its components.|
1750388|NCT00346775|3215987|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.517|2-Sided|95.0|-0.6|0.3|||ANCOVA||||
1750389|NCT00346697|3215990|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)||||
1750390|NCT00346697|3215991|Superiority or Other|||||||0.12|||||||Wilcoxon (Mann-Whitney)||||
1750391|NCT00346697|3215992|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)||||
1750392|NCT00346697|3215993|Superiority or Other|||||||0.25|||||||Wilcoxon (Mann-Whitney)||||
1750393|NCT00346697|3215994|Superiority or Other|||||||0.89|||||||Wilcoxon (Mann-Whitney)||||
1750394|NCT00346697|3215995|Superiority or Other|||||||0.89|||||||Wilcoxon (Mann-Whitney)||||
1750395|NCT00346697|3215996|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)||||
1750396|NCT00346697|3215997|Superiority or Other|||||||0.006|||||||Wilcoxon (Mann-Whitney)||||
1750397|NCT00346697|3215998|Superiority or Other|||||||0.2|||||||Wilcoxon (Mann-Whitney)||||
1750398|NCT00346697|3215999|Superiority or Other|||||||0.7|||||||Wilcoxon (Mann-Whitney)||||
1750399|NCT00346697|3216000|Superiority or Other|||||||0.96|||||||Wilcoxon (Mann-Whitney)||||
1750400|NCT00346697|3216001|Superiority or Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)||||
1750401|NCT00346697|3216002|Superiority or Other|||||||0.72|||||||Wilcoxon (Mann-Whitney)||||
1750402|NCT00346697|3216003|Superiority or Other|||||||0.8|||||||Wilcoxon (Mann-Whitney)||||
1750403|NCT00346697|3216004|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1750404|NCT00346398|3216018|Superiority or Other||Hazard Ratio (HR)|1.8||||0.28|2-Sided|95.0|0.6|5.6||P-value is calculated using a log-rank test|Regression, Logistic||Hazard ratio and 95% confidence intervals are calculated using an unadjusted Cox regression||
1750405|NCT00346398|3216019|Superiority or Other||Odds Ratio (OR)|1.0||||0.85|2-Sided|95.0|0.2|6.1||Odds Ratios are calculated using unadjusted exact logistic regression with mid p-value to adjust for the discreteness of the distribution|Chi-squared|||Participants who drop out (have missing efficacy endpoints) are considered treatment failures.|
1750406|NCT00346398|3216020|Superiority or Other||Odds Ratio (OR)|2.3||||0.28|2-Sided|95.0|0.5|10.5||Odds Ratios are calculated using a logistic regression with a Wald chi square test. Experimental group participants had a higher proportion of allergic sensitization than participants who received placebo|Chi-squared|||Participants who drop out (have missing efficacy endpoints) are considered treatment failures.|
1750407|NCT00346333|3216021|Superiority or Other|||||||0.8||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O’Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Proc MIXED of SAS was used to compare annual rates of change over 4 years between the 2 groups.|
1750408|NCT00346333|3216022|Superiority or Other|||||||0.59||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O’Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Proc MIXED of SAS was used to compare annual rates of change over four years between the treatment groups.|
1750409|NCT00346333|3216023|Superiority or Other|||||||0.2||||||Apriori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O’Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.|
1750410|NCT00346333|3216023|Superiority or Other|||||||0.24||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O’Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Primary analysis:Proc Mixed of SAS was used to compare annual rates of change by treatment group over four years.The unit of analysis was the eye.Each patient contributed 2,1,or 0 eyes with non-missing data.|
1750411|NCT00346333|3216024|Superiority or Other|||||||0.03||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O’Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.|
1750412|NCT00346333|3216024|Superiority or Other|||||||0.05||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O’Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||Primary Analysis: Proc Mixed of SAS was used to compare annual rates of change by treatment group over four years.The unit of analysis was the eye. Each patient contributed 2, 1, or 0 eyes with non-missing data.|
1750413|NCT00346333|3216025|Superiority or Other|||||||0.52||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O’Brien-Fleming rule for intermediate looks.|Clustered Wilcoxon|||Secondary Analysis: As change distribution was non-normal, slope for each eye was calculated with least squares regression and converted to ranks. The Clustered Wilcoxon test was used to compare slope distributions between groups accounting for correlation between slopes for eyes within individuals.|
1750414|NCT00346333|3216025|Superiority or Other|||||||0.66||||||A priori threshold for statistical significance= 0.05. Annual assessments of data by data monitoring board were done with p-values adjusted using the O’Brien-Fleming rule for intermediate looks.|Longitudinal regression analysis|||"Primary Analysis:Proc mixed of the Statistical Analysis System (SAS) was used to compare annual rates of change by treatment group over 4 years.~Power Calculation:240 patients were estimated to be needed to provide sufficient power (i.e. alpha=0.05;beta=0.10)to observe a statistically significant difference between mean change in the 2 groups on the HFA 30-2 total point score over a 4-year interval."|
1750415|NCT00346268|3216032|Superiority or Other||LS mean difference (net)|-0.83|Standard Error of the Mean|0.3||0.006|2-Sided|95.0|-1.41|-0.24||Adjusted for treatment group and center|ANOVA|||48 hours post surgery|
1750416|NCT00346268|3216032|Superiority or Other||LS mean difference (net)|-1.16|Standard Error of the Mean|0.3||0.001|2-Sided|95.0|-1.77|-0.56||Adjusted for treatment group and center|ANOVA|||24 hours post surgery|
1750417|NCT00346268|3216033|Superiority or Other||LS mean difference (net)|-0.73|Standard Error of the Mean|0.25||0.004|2-Sided|95.0|-1.22|-0.23||Adjusted for treatment group and center|ANOVA|||48 hours post surgery|
1750418|NCT00346268|3216033|Superiority or Other||LS mean difference (net)|-0.71|Standard Error of the Mean|0.23||0.002|2-Sided|95.0|-1.16|-0.26||Adjusted for treatment group and center|ANOVA|||24 hours post surgery|
1750419|NCT00346268|3216034|Superiority or Other||LS Mean Difference (net)|0.16|Standard Error of the Mean|0.09||0.074|2-Sided|95.0|-0.02|0.33|||ANOVA|||The difference in pain at movement prior to administration and pain at movement post administration compared between treatments at 48 hours post surgery.|
1750420|NCT00346268|3216034|Superiority or Other||Least squares mean difference (net)|0.17|Standard Error of the Mean|0.09||0.07|2-Sided|95.0|-0.01|0.35|||ANOVA|||The difference in pain at rest prior to administration and pain at rest post administration compared between treatments at 48 hours post surgery.|
1750421|NCT00346268|3216036|Superiority or Other||LS mean difference (net)|-0.07|Standard Error of the Mean|0.3||0.81|2-Sided|95.0|-0.68|0.53||Adjusted for treatment group and center|ANCOVA|Covariates:Total RBCUs and RBCUs substituted during surgery, baseline hemoglobin, swab and lavage weights, intraoperative blood loss fluid volume|||
1750422|NCT00346268|3216037|Superiority or Other|||||||0.257|||||||Log Rank|Stratified by center|||
1750552|NCT00345839|3216113|Superiority or Other||Hazard Ratio (HR)|0.82|||||2-Sided|95.0|0.68|0.99|||||HR is cinacalcet vs placebo.||
1750424|NCT00346268|3216039|Superiority or Other||least square (LS) mean difference (net)|-7.58|Standard Error of the Mean|3.55||0.035|2-Sided|95.0|-14.63|-0.53||Adjusted for treatment group and center|ANOVA||||
1750425|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|1.24|Standard Error of the Mean|0.55||0.0251|2-Sided|95.0|0.16|2.33|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)|
1750426|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|-0.81|Standard Error of the Mean|0.55||0.1439|2-Sided|95.0|-1.89|0.28|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)|
1750427|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.43|Standard Error of the Mean|0.55||0.4323|2-Sided|95.0|-0.65|1.52|||Mixed Models Analysis|||Change from baseline to Month 42 (MITT)|
1750428|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.74|Standard Error of the Mean|0.53||0.1653|2-Sided|95.0|-0.31|1.78|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)|
1750429|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.53||0.7668|2-Sided|95.0|-0.88|1.2|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)|
1750430|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.9|Standard Error of the Mean|0.53||0.091|2-Sided|95.0|-0.14|1.94|||Mixed Models Analysis|||Change from baseline to Month 36 (MITT)|
1750431|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.51||0.903|2-Sided|95.0|-0.94|1.06|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)|
1750432|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.55|Standard Error of the Mean|0.51||0.2758|2-Sided|95.0|-0.44|1.55|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)|
1750433|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.62|Standard Error of the Mean|0.51||0.225|2-Sided|95.0|-0.38|1.61|||Mixed Models Analysis|||Change from baseline to Month 30 (MITT)|
1750434|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.47||0.9144|2-Sided|95.0|-0.88|0.98|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)|
1750435|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.47||0.9998|2-Sided|95.0|-0.92|0.92|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)|
1750436|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.47||0.9139|2-Sided|95.0|-0.87|0.97|||Mixed Models Analysis|||Change from baseline to Month 24 (MITT)|
1750437|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.45||0.3737|2-Sided|95.0|-0.49|1.29|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)|
1750438|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|-0.21|Standard Error of the Mean|0.45||0.6381|2-Sided|95.0|-1.1|0.67|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)|
1750439|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.45||0.6725|2-Sided|95.0|-0.69|1.08|||Mixed Models Analysis|||Change from baseline to Month 18 (MITT)|
1750440|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.47|Standard Error of the Mean|0.44||0.2796|2-Sided|95.0|-0.38|1.33|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)|
1750441|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.44||0.5061|2-Sided|95.0|-0.57|1.15|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)|
1750442|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.76|Standard Error of the Mean|0.44||0.0796|2-Sided|95.0|-0.09|1.62|||Mixed Models Analysis|||Change from baseline to Month 12 (MITT)|
1750443|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.42||0.651|2-Sided|95.0|-0.63|1.01|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)|
1750444|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.42||0.5893|2-Sided|95.0|-0.6|1.05|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)|
1750445|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.42|Standard Error of the Mean|0.42||0.3202|2-Sided|95.0|-0.4|1.24|||Mixed Models Analysis|||Change from baseline to Month 8 (MITT)|
1750446|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.77|Standard Error of the Mean|0.39||0.0516|2-Sided|95.0|-0.01|1.54|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)|
1750447|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.39||0.8314|2-Sided|95.0|-0.86|0.69|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)|
1750448|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.68|Standard Error of the Mean|0.39||0.0822|2-Sided|95.0|-0.09|1.46|||Mixed Models Analysis|||Change from baseline to Month 4 (MITT)|
1750449|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.65|Standard Error of the Mean|0.37||0.0802|2-Sided|95.0|-0.08|1.39|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)|
1750450|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.37||0.8278|2-Sided|95.0|-0.81|0.65|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)|
1750451|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.57|Standard Error of the Mean|0.37||0.1247|2-Sided|95.0|-0.16|1.31|||Mixed Models Analysis|||Change from baseline to Month 2 (MITT)|
1750452|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.93|Standard Error of the Mean|0.36||0.0094|2-Sided|95.0|0.23|1.64|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)|
1750453|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.84|Standard Error of the Mean|0.36||0.0197|2-Sided|95.0|0.13|1.54|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)|
1750454|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|1.77|Standard Error of the Mean|0.36|<|0.0001|2-Sided|95.0|1.07|2.47|||Mixed Models Analysis|||Change from Baseline to Month 1 (MITT)|
1750455|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|1.29|Standard Error of the Mean|0.52|<|0.0137|2-Sided|95.0|0.26|2.31|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)|
1750456|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|-0.83|Standard Error of the Mean|0.52|<|0.1123|2-Sided|95.0|-1.85|0.19|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)|
1750457|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.46|Standard Error of the Mean|0.52|<|0.3767|2-Sided|95.0|-0.56|1.48|||Mixed Models Analysis|||Change from baseline to Month 42 (ITT)|
1750458|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.79|Standard Error of the Mean|0.51|<|0.1202|2-Sided|95.0|-0.21|1.79|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)|
1750459|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.51|<|0.9751|2-Sided|95.0|-0.98|1.01|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)|
1750460|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.81|Standard Error of the Mean|0.51|<|0.1116|2-Sided|95.0|-0.19|1.8|||Mixed Models Analysis|||Change from baseline to Month 36 (ITT)|
1750461|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.49|<|0.8459|2-Sided|95.0|-0.86|1.05|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)|
1750462|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.51|Standard Error of the Mean|0.49|<|0.2909|2-Sided|95.0|-0.44|1.46|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)|
1750463|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.61|Standard Error of the Mean|0.49|<|0.2105|2-Sided|95.0|-0.34|1.56|||Mixed Models Analysis|||Change from baseline to Month 30 (ITT)|
1750464|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.46|<|0.7784|2-Sided|95.0|-0.77|1.03|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)|
1750465|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.46|<|0.9641|2-Sided|95.0|-0.92|0.87|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)|
1750466|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.46|<|0.8127|2-Sided|95.0|-0.79|1.0|||Mixed Models Analysis|||Change from baseline to Month 24 (ITT)|
1750467|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.51|Standard Error of the Mean|0.44|<|0.2461|2-Sided|95.0|-0.35|1.38|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)|
1750468|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.44|<|0.5996|2-Sided|95.0|-1.1|0.63|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)|
1750469|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.28|Standard Error of the Mean|0.44|<|0.5225|2-Sided|95.0|-0.58|1.14|||Mixed Models Analysis|||Change from baseline to Month 18 (ITT)|
1750470|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.47|Standard Error of the Mean|0.43|<|0.2705|2-Sided|95.0|-0.37|1.3|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)|
1750471|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.32|Standard Error of the Mean|0.43|<|0.454|2-Sided|95.0|-0.52|1.15|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)|
1750472|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.79|Standard Error of the Mean|0.42|<|0.0632|2-Sided|95.0|-0.04|1.62|||Mixed Models Analysis|||Change from baseline to Month 12 (ITT)|
1750473|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.42|<|0.5774|2-Sided|95.0|-0.58|1.05|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)|
1750474|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.41|<|0.6526|2-Sided|95.0|-0.63|1.0|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)|
1750475|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.42|Standard Error of the Mean|0.41|<|0.3129|2-Sided|95.0|-0.39|1.23|||Mixed Models Analysis|||Change from baseline to Month 8 (ITT)|
1750476|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.76|Standard Error of the Mean|0.4|<|0.0587|2-Sided|95.0|-0.03|1.55|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)|
1750477|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.4|<|0.8237|2-Sided|95.0|-0.88|0.7|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)|
1750478|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.67|Standard Error of the Mean|0.4|<|0.8237|2-Sided|95.0|-0.12|1.46|||Mixed Models Analysis|||Change from baseline to Month 4 (ITT)|
1750479|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.63|Standard Error of the Mean|0.39|<|0.1072|2-Sided|95.0|-0.14|1.4|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)|
1750480|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.39|<|0.7777|2-Sided|95.0|-0.88|0.66|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)|
1750481|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.52|Standard Error of the Mean|0.39|<|0.183|2-Sided|95.0|-0.25|1.29|||Mixed Models Analysis|||Change from baseline to Month 2 (ITT)|
1750482|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.96|Standard Error of the Mean|0.39|<|0.0129|2-Sided|95.0|0.2|1.72|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)|
1750483|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|0.81|Standard Error of the Mean|0.39|<|0.0373|2-Sided|95.0|0.05|1.56|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)|
1750484|NCT00346216|3216040|Superiority or Other||Mean Difference (Final Values)|1.77|Standard Error of the Mean|0.39|<|0.0001|2-Sided|95.0|1.01|2.53|||Mixed Models Analysis|||Change from baseline to Month 1 (ITT)|
1750485|NCT00346216|3216041|Superiority or Other||Hazard Ratio (HR)|1.16||||0.4243|2-Sided|95.0|0.8|1.69|||Regression, Cox|||MITT Population|
1750486|NCT00346216|3216041|Superiority or Other||Hazard Ratio (HR)|0.43||||0.0003|2-Sided|95.0|0.27|0.68|||Regression, Cox|||MITT Population|
1750487|NCT00346216|3216041|Superiority or Other||Hazard Ratio (HR)|0.51||||0.0041|2-Sided|95.0|0.32|0.81|||Regression, Cox|||MITT Population|
1750488|NCT00346216|3216041|Superiority or Other||Hazard Ratio (HR)|1.27||||0.1734|2-Sided|95.0|0.9|1.81|||Regression, Cox|||ITT Population|
1750489|NCT00346216|3216041|Superiority or Other||Hazard Ratio (HR)|0.76||||0.1202|2-Sided|95.0|0.53|1.08|||Regression, Cox|||ITT Population|
1750490|NCT00346216|3216041|Superiority or Other||Hazard Ratio (HR)|0.97||||0.8576|2-Sided|95.0|0.67|1.4|||Regression, Cox|||ITT Population|
1750493|NCT00346216|3216042|Superiority or Other||Hazard Ratio (HR)|0.95||||0.5758|2-Sided|95.0|0.8|1.13|||Regression, Cox|||MITT Population|
1750494|NCT00346216|3216042|Superiority or Other||Hazard Ratio (HR)|1.11||||0.1481|2-Sided|95.0|0.96|1.29|||Regression, Cox|||ITT Population|
1750495|NCT00346216|3216042|Superiority or Other||Hazard Ratio (HR)|0.87||||0.0597|2-Sided|95.0|0.75|1.01|||Regression, Cox|||ITT Population|
1750496|NCT00346216|3216042|Superiority or Other||Hazard Ratio (HR)|0.97||||0.6427|2-Sided|95.0|0.83|1.12|||Regression, Cox|||ITT Population|
1750497|NCT00346216|3216043|Non-Inferiority or Equivalence|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40|Hazard Ratio (HR)|1.12||||0.025|2-Sided|95.0|0.89|1.4||Non-inferiority P-value, α=0.025|Regression, Cox|||MITT Population|
1750498|NCT00346216|3216043|Non-Inferiority or Equivalence|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.33|Hazard Ratio (HR)|1.08||||0.0182|2-Sided|95.0|0.89|1.31||Non-inferiority P-value, α=0.025|Regression, Cox|||ITT Population|
1750499|NCT00346216|3216043|Non-Inferiority or Equivalence|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio (HR) estimate does not exceed 1.40|Hazard Ratio (HR)|0.81|||<|0.0001|2-Sided|95.0|0.64|1.02||Non-inferiority P-value, α=0.025|Regression, Cox|||MITT Population|
1750500|NCT00346216|3216043|Non-Inferiority or Equivalence|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.33|Hazard Ratio (HR)|0.86|||<|0.0001|2-Sided|95.0|0.7|1.04||Non inferiority P value, α=0.025|Regression, Cox|||ITT Population|
1750501|NCT00346216|3216043|Non-Inferiority or Equivalence|Non-inferiority requires the hazard ratio does not exceed 1.12, and the upper bound of the two-sided 95% CI for the hazard ratio estimate does not exceed 1.40|Hazard Ratio (HR)|0.9|||<|0.0001|2-Sided|95.0|0.72|1.14||Non inferiority P value, α=0.025|Regression, Cox|||MITT Population|
1750502|NCT00346216|3216043|Non-Inferiority or Equivalence|Non inferiority required a hazard ratio of 1.12 or lower, as well as an upper 95% confidence limit of 1.33 or lower in the ITT population and of 1.40 or lower in the MITT population.|Hazard Ratio (HR)|0.93|||<|0.0002|2-Sided|95.0|0.76|1.13||Non inferiority P value, α=0.025|Regression, Cox|||ITT Population|
1750503|NCT00346164|3216044|Other||Kappa statistic|0.42|||||2-Sided|95.0|0.36|0.48||||||Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.|
1750504|NCT00346164|3216045|Other||Kappa statistic|0.82|||||2-Sided|95.0|0.76|0.88||||||Kappa statistic and its 95% confidence interval are used to assess agreement beyond random.|
1750505|NCT00346164|3216047|Other|||||||0.0228|||||||Regression, Logistic|Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.||The logistic regression model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (<=5cm; >5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .|
1750506|NCT00346164|3216048|Other||||||<|0.0001|||||||Regression, Logistic|Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.||The logistic regression model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (<=5cm; >5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.|
1750507|NCT00346164|3216049|Other|||||||0.0096|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of the resection extent of the primary tumor (less than total resection; margin -; margin +) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), disease extent (non-metastatic; metastatic), tumor size (<=5cm; >5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and histologic (POG) grade.|
1750508|NCT00346164|3216050|Other||||||<|0.0001|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (<=5cm; >5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.|
1750509|NCT00346164|3216051|Other|||||||0.0049|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (<=5cm; >5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .|
1750510|NCT00346164|3216052|Other||||||<|0.0001|||||||Regression, Cox|||The Cox proportional hazards model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (<=5cm; >5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.|
1750511|NCT00346151|3216057|Superiority or Other||Incidence Rate|20.0||||||95.0|0.5|71.6||||||Proportion with 95% exact binomial confidence interval|
1750512|NCT00346151|3216058|Superiority or Other||Incidence Rate|0.0||||||95.0|0.0|52.2||||||Proportion with 95% exact binomial confidence interval|
1750513|NCT00346151|3216059|Superiority or Other||Incidence Rate|0.0||||||95.0|0.0|52.2||||||Proportion with 95% exact binomial confidence interval|
1750514|NCT00346151|3216060|Superiority or Other||Incidence Rate|100.0||||||95.0|47.8|100.0||||||Proportion with 95% exact binomial confidence interval|
1750515|NCT00346151|3216061|Superiority or Other||Incidence Rate|0.0||||||95.0|0.0|52.2||||||Proportion with 95% exact binomial confidence interval|
1750516|NCT00346151|3216062|Superiority or Other||Incidence Rate|0.0||||||95.0|0.0|52.2||||||Proportion with 95% exact binomial confidence interval|
1750517|NCT00346151|3216063|Superiority or Other||Incidence Rate|80.0||||||95.0|28.0|99.0||||||Proportion with 95% exact binomial confidence interval|
1750518|NCT00346151|3216064|Superiority or Other||Incidence Rate|0.0||||||95.0|0.0|52.2||||||Proportion with 95% exact binomial confidence interval|
1750519|NCT00346151|3216066|Superiority or Other||Incidence Rate|100.0||||||95.0|40.0|100.0||||||Proportion with 95% exact binomial confidence interval|
1750520|NCT00346151|3216069|Superiority or Other||Incidence rate|80.0||||||95.0|28.0|99.0||||||Proportion with 95% exact binomial confidence interval|
1750521|NCT00346151|3216070|Superiority or Other||Incidence Rate|100.0||||||95.0|40.0|100.0||||||Proportion with 95% exact binomial confidence interval|
1750522|NCT00346151|3216071|Superiority or Other||Incidence Rate|60.0||||||95.0|15.0|95.0||||||Proportion of participant's cumulative incidence of acute rejection at 24 weeks with 95% exact binomial confidence interval. Local biopsy reads were used in determining primary endpoint.|
1750523|NCT00346073|3216083|Superiority||Booster response|93.2|||||2-Sided|95.0|91.8|94.4||||||"Demonstration that anti-PRN booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."|
1750524|NCT00346073|3216083|Superiority||Booster response|96.9|||||2-Sided|95.0|95.8|97.7||||||"Demonstration that anti-FHA booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."|
1750525|NCT00346073|3216083|Superiority||Booster response|77.2|||||2-Sided|95.0|74.9|79.3||||||"Demonstration that anti-PT booster response occurred in at least 80% of adults receiving a single dose of Boostrix® vaccine, one month after vaccination.~Criterion for evaluation: one month after vaccination, the lower limit of the 95% confidence interval (CI) for the percentage of subjects with a booster response was greater than or equal to (≥) 80%."|
1750526|NCT00346073|3216085|Non-Inferiority|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group – Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-1.04|||||2-Sided|95.0|-1.97|0.0||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 1.0 IU/mL, one month after vaccination.|
1750527|NCT00346073|3216086|Non-Inferiority|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group – Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-0.42|||||2-Sided|95.0|-0.9|0.11||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) 0.1 IU/mL, one month after vaccination.|
1750528|NCT00346073|3216086|Non-Inferiority|The primary objective of non-inferiority was met if the lower limit of the 95% confidence intervals (CIs), between the two groups (Boostrix Group – Adacel Group) were greater than or equal to (≥) -10%|Difference in percentage|-0.43|||||2-Sided|95.0|-1.47|0.84||||||The non-inferiority of Boostrix® vaccine compared to Adacel™ vaccine, with respect to the percentage of subjects with anti-diphtheria (anti-D) antibody concentrations greater than or equal to (≥) 0.1 IU/mL, one month after vaccination.|
1750529|NCT00345969|3216089|Superiority or Other|||||||0.13|||||||ANOVA||||
1750530|NCT00345969|3216090|Superiority or Other|||||||0.89|||||||ANOVA||||
1750531|NCT00345969|3216091|Superiority or Other|||||||0.44|||||||ANOVA||||
1750532|NCT00345969|3216092|Superiority or Other|||||||0.71|||||||ANOVA||||
1750533|NCT00345969|3216093|Superiority or Other|||||||0.19|||||||ANOVA||||
1750534|NCT00345969|3216094|Superiority or Other|||||||0.49|||||||ANOVA||||
1750535|NCT00345969|3216095|Superiority or Other|||||||0.24|||||||ANOVA||||
1750536|NCT00345969|3216096|Superiority or Other|||||||0.93|||||||ANOVA||||
1750537|NCT00345969|3216097|Superiority or Other|||||||0.33|||||||ANOVA||||
1750538|NCT00345969|3216098|Superiority or Other|||||||0.43|||||||ANOVA||||
1750539|NCT00345969|3216099|Superiority or Other|||||||0.23|||||||ANOVA||||
1750540|NCT00345969|3216100|Superiority or Other|||||||0.55|||||||ANOVA||||
1750541|NCT00345969|3216101|Superiority or Other|||||||0.01|||||||ANOVA||||
1750542|NCT00345839|3216108|Superiority or Other||Hazard Ratio (HR)|0.44|||||2-Sided|95.0|0.36|0.54|||||HR is cinacalcet vs placebo.||
1750543|NCT00345839|3216108|Superiority or Other||||||<|0.001||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.|||
1750544|NCT00345839|3216109|Superiority or Other||Hazard Ratio (HR)|0.89|||||2-Sided|95.0|0.75|1.07|||||HR is cinacalcet vs placebo.||
1750545|NCT00345839|3216109|Superiority or Other|||||||0.218||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.|||
1750546|NCT00345839|3216110|Superiority or Other||Hazard Ratio (HR)|1.07|||||2-Sided|95.0|0.82|1.4|||||HR is cinacalcet vs placebo.||
1750547|NCT00345839|3216110|Superiority or Other|||||||0.607||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.|||
1750548|NCT00345839|3216111|Superiority or Other||Hazard Ratio (HR)|0.92|||||2-Sided|95.0|0.8|1.07|||||HR is cinacalcet vs placebo.||
1750549|NCT00345839|3216111|Superiority or Other|||||||0.277||||||No adjustments for multiple comparisons were made for this endpoint.|Log Rank|Stratified by history of diabetes and country. 2-sided test.|||
1750550|NCT00345839|3216112|Superiority or Other||Hazard Ratio (HR)|0.87|||||2-Sided|95.0|0.72|1.07|||||HR is cinacalcet vs placebo.||
1750551|NCT00345839|3216112|Superiority or Other|||||||0.19||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.|||
1751342|NCT00327717|3217920|Superiority or Other|||||||0.09|||||||X^2 test||||
1750553|NCT00345839|3216113|Superiority or Other|||||||0.034||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.|||
1750554|NCT00345839|3216114|Superiority or Other||Hazard Ratio (HR)|0.82|||||2-Sided|95.0|0.58|1.18|||||HR is cinacalcet vs placebo.||
1750555|NCT00345839|3216114|Superiority or Other|||||||0.283||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.|||
1750556|NCT00345839|3216115|Superiority or Other||Hazard Ratio (HR)|0.97|||||2-Sided|95.0|0.79|1.19|||||HR is cinacalcet vs placebo.||
1750557|NCT00345839|3216115|Superiority or Other|||||||0.8||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.|||
1750558|NCT00345839|3216116|Superiority or Other||Hazard Ratio (HR)|0.94|||||2-Sided|95.0|0.85|1.04|||||HR is cinacalcet vs placebo.||
1750559|NCT00345839|3216116|Superiority or Other|||||||0.249||||||No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.|Log Rank|Stratified by history of diabetes and country. 2-sided test.|||
1750560|NCT00345839|3216117|Superiority or Other||Hazard Ratio (HR)|0.93|||||2-Sided|95.0|0.85|1.02|||||HR is cinacalcet vs placebo.||
1750561|NCT00345839|3216117|Superiority or Other|||||||0.112||||||p-value<0.044 considered significant|Log Rank|Stratified by history of diabetes and country. 2-sided test.|||
1750562|NCT00345631|3216127|Superiority or Other||Proportion difference|0.7||||0.85|2-Sided|95.0|-4.8|7.4|||t-test, 2 sided|||Null hypothesis: The percentages of patients achieving procedure success between the vascular closure device and manual compression arms are equal.|
1750563|NCT00345631|3216130|Superiority or Other||Mean Difference (Final Values)|-2.57||||0.3612|2-Sided|95.0|-7.46|2.31|||t-test, 2 sided|||Null hypothesis: The mean time to hospital discharge for the manual compression (MC) arm is equal to that for the vascular closure device (VCD) arm.|
1750564|NCT00345631|3216131|Superiority or Other||Mean Difference (Final Values)|-3.7||||0.154|2-Sided|95.0|-7.84|0.45|||t-test, 2 sided|||Null hypothesis: The mean time to eligibility for hospital discharge for the manual compression (MC) arm is equal to that for the vascular closure device (VCD) arm.|
1750565|NCT00345631|3216132|Non-Inferiority or Equivalence|The sample size is adequate to rule out a 4% or larger disadvantage for VCD vs. MC (null hypothesis: 2.5% MC vs. 6.5% VCD) in the incidence of major complications for VCD vs. MC using a 95% upper confidence bound for the VCD – MC difference with 80% power and a 5% one-sided Type I error|Mean Difference (Final Values)|0.0||||0.0006|1-Sided|95.0||1.14||P-value was calculated using unconditional exact test of non-inferiority for difference of two binomial proportions (VCD vs. MC) with a margin of 4%.|unconditional exact test|||Based on pre-planned hypotheses, a minimum sample size of 390 randomized patients (260 VCD patients and 130 MC patients) would demonstrate non-inferiority for the primary safety endpoint and superiority for both co-primary effectiveness endpoints in comparing VCD vs. MC.|
1750566|NCT00345631|3216133|Superiority or Other||Median Difference (Final Values)|-3.7||||0.0028|2-Sided|95.0|-5.53|-1.87||Multiplicity is addressed for the two co-primary effectiveness endpoints via a closed testing procedure where the time to hemostasis will be assessed first and then time to ambulation only if significance is first achieved for time to hemostasis.|t-test, 2 sided|||"Null hypothesis:The mean time to ambulation for the manual compression (MC) arm is less or equal to that for the vascular closure device (VCD) arm.~The trial is powered to detect a 5 minute reduction in mean time to hemostasis and a 2 hour reduction in mean time to ambulation for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) Type I error"|
1750567|NCT00345631|3216134|Superiority or Other||Mean Difference (Net)|-15.68|||<|0.0001|2-Sided|95.0|-19.04|-12.31||Multiplicity is addressed for the two co-primary effectiveness endpoints via a closed testing procedure where the time to hemostasis will be assessed first and then time to ambulation only if significance is first achieved for time to hemostasis.|t-test, 2 sided|||"Null hypothesis: The mean time to hemostasis for the manual compression (MC) arm is less or equal to that for the vascular closure device (VCD) arm.~The trial is powered to detect a 5 minute reduction in mean time to hemostasis and a 2 hour reduction in mean time to ambulation for VCD vs. MC with over 90% power and a 5% two-sided (2.5% one-sided) Type I error"|
1750568|NCT00345605|3216141|Superiority or Other||Slope|0.5|||||2-Sided||||||||Assuming r=0.5 between two measurements from the same subject, 12 subjects would provide a power of 0.8 to detect a 10% reduction in primary endpoints at an alpha value of 0.05.|For sample size calculation, we used the means and standard deviation for PT, PTT. Assuming r=0.5 between two measurements from the same subject, 12 subjects would provide a power of 0.8 to detect a 10% reduction in primary endpoints at an alpha value of 0.05.|
1750569|NCT00345592|3216142|Superiority or Other||Hazard Ratio (HR)|0.987|||||2-Sided|95.0|0.684|1.503|||||||
1750570|NCT00345384|3216155|Superiority or Other|||||||0.02|||||||t-test, 2 sided|||The p-value reported in this table corresponds with the 6 to 16 hour time frame.|
1750571|NCT00345384|3216156|Superiority or Other||Percentage difference|35.0||||0.04|2-Sided|95.0|||||t-test, 2 sided||A measure of opioid use, weighted for total time on study drug. This is examined by a comparison of the dexmedetomidine group to the placebo group: numerator = 35, denominator = 54.||
1750572|NCT00345384|3216156|Superiority or Other||Precentage Difference|41.0||||0.03|2-Sided|95.0|||||t-test, 2 sided||The percentage in opioid use by the dexmedetomidine group in comparison to the placebo for the period of time on study drug is calculated as follows: numerator = 29, denominator = 49.||
1750573|NCT00345332|3216189|Superiority or Other||||||<|0.01|||||||ANOVA||||
1750574|NCT00345332|3216190|Superiority or Other||||||<|0.01|||||||ANOVA||||
1750575|NCT00345254|3216194|Superiority|||||||0.1|||||||t-test, 2 sided||||
1750576|NCT00345176|3216200|Superiority or Other||Hazard Ratio (HR)|0.96|||<|0.05|2-Sided|95.0|0.84|1.1|||Regression, Cox||||
1750607|NCT00343252|3216360|Superiority or Other|||||||0.399||||||P-value is for responder versus non-responder.|Chi-squared||||
1750577|NCT00345176|3216201|Superiority or Other||Hazard Ratio (HR)|1.23|||<|0.05|2-Sided|95.0|0.92|1.65|||Regression, Cox|||Comparison of Lutein/Zeaxanthin + DHA/EPA versus Placebo for Mortality|
1750578|NCT00345176|3216201|Superiority or Other||Hazard Ratio (HR)|1.13|||<|0.05|2-Sided|95.0|0.84|1.52|||Regression, Cox|||Comparison of DHA/EPA versus Placebo for mortality|
1750579|NCT00345176|3216201|Superiority or Other||Hazard Ratio (HR)|1.04|||<|0.05|2-Sided|95.0|0.77|1.4|||Regression, Cox|||Comparison of Lutein/Zeaxantin versus Control for mortality|
1750580|NCT00345176|3216202|Superiority or Other||Hazard Ratio (HR)|0.94|||<|0.05|2-Sided|95.0|0.83|1.07|||Regression, Cox||||
1750581|NCT00345176|3216202|Superiority or Other||Hazard Ratio (HR)|0.96|||<|0.05|2-Sided|95.0|0.84|1.09|||Regression, Cox||||
1750582|NCT00345176|3216202|Superiority or Other||Hazard Ratio (HR)|0.95|||<|0.05|2-Sided|95.0|0.84|1.08|||Regression, Cox||||
1750583|NCT00345176|3216203|Superiority or Other||Hazard Ratio (HR)|0.89|||<|0.013|2-Sided|98.7|0.75|1.06|||Regression, Cox|Adjusted for multiple comparisons|||
1750584|NCT00345176|3216203|Superiority or Other||Hazard Ratio (HR)|0.97|||<|0.013|2-Sided|98.7|0.82|1.16||Adjusted for multiple comparisons|Regression, Cox||||
1750585|NCT00345176|3216203|Superiority or Other||Hazard Ratio (HR)|0.9|||<|0.013|2-Sided|98.7|0.76|1.07||Adjusted for 3 treatment versus placebo comparisons and interim analyses|Regression, Cox|Adjusted for baseline AMD status|The reference group is placebo.|Each of the 3 active arms was compared to the placebo/control arm.|
1750586|NCT00345033|3216205|Non-Inferiority or Equivalence|A priori power calculation determined the power to detect a change in Insulin Resistance will be 90%.||||||0.082|||||||ANCOVA||||
1750587|NCT00345033|3216206|Non-Inferiority or Equivalence|A priori power calculation determined the power to detect a change in triglycerides will be 81%.||||||0.982|||||||ANCOVA||||
1750588|NCT00345033|3216207|Non-Inferiority or Equivalence|A priori power calculation determined the power to detect a change in glucose metabolism to be 90%.||||||0.01|||||||ANCOVA||||
1750589|NCT00345033|3216208|Non-Inferiority or Equivalence|A priori power calculation determined the power to detect a change in Body Mass Index (BMI) will be over 99%.||||||0.229|||||||ANCOVA||||
1750590|NCT00345033|3216209|Non-Inferiority or Equivalence|A priori power calculation determined the power to detect a change in weight will be over 99%.||||||0.109|||||||ANCOVA||||
1750591|NCT00345033|3216210|Non-Inferiority or Equivalence|A priori power calculation determined the power to detect a change in total cholesterol is over 99%.||||||0.125|||||||ANCOVA||||
1750592|NCT00344500|3216223|Superiority or Other||||||<|0.01|||||||Mixed Models Analysis|Predicted trajectory of mean weight change between matched UC and LB subjects over 12 months (treatment*time interaction: F(1,1275)=68.75, p<.01).||General Linear Mixed Model (GLMM) used to illustrate the magnitude of difference between slopes for major outcomes for two hypothetical participants with identical baseline characteristics over 12 months.|
1750593|NCT00344318|3216265|Non-Inferiority or Equivalence|Standardized asymptotic 95% confidence interval (CI) for the difference [Synflorix™ minus Prevenar™] in terms of percentages of subjects reporting rectal fever >39.0°C across doses was computed.|Difference in percentage|3.13|||||2-Sided|95.0|-2.65|8.01||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever >39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.|
1750594|NCT00344318|3216265|Non-Inferiority or Equivalence|Towards this, standardized asymptotic 95% confidence interval (CI) for the difference [Synflorix™ minus Prevenar™] in terms of percentages of subjects reporting rectal fever >39.0°C after Dose 3 was computed.|Difference in percentage|3.05|||||2-Sided|95.0|-1.02|6.19||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever >39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.|
1750595|NCT00344318|3216265|Non-Inferiority or Equivalence|Towards this, standardized asymptotic 95% confidence interval (CI) for the difference [Synflorix™ minus Prevenar™] in terms of percentages of subjects reporting rectal fever >39.0°C after Dose 2 was computed|Difference in percentage|-1.48||||||95.0|-6.05|1.92||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever >39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.|
1750596|NCT00344318|3216265|Non-Inferiority or Equivalence|Standardized asymptotic 95% confidence interval (CI) for the difference [Synflorix™ minus Prevenar™] in terms of percentages of subjects reporting rectal fever >39.0°C after Dose 1 was computed.|Difference in percentage|2.17|||||2-Sided|95.0|-1.51|4.88||||||Analysis aimed to demonstrate that Synflorix™ vaccine administered as a 3-dose primary vaccination course (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to Prevenar™ in terms of the incidence of post-immunization rectal fever >39.0°C, when co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ or Poliorix™ vaccines.|
1750597|NCT00343382|3216349|Superiority or Other|||||||0.062|||||||Kruskal-Wallis|||Comparison of sweating among arms|
1750598|NCT00343382|3216349|Superiority or Other|||||||0.03|||||||Kruskal-Wallis|||Comparison of nausea among arms|
1750599|NCT00343382|3216349|Superiority or Other|||||||0.006|||||||Kruskal-Wallis|||Comparison of Urinary Frequency among arms|
1750600|NCT00343382|3216349|Superiority or Other|||||||0.002|||||||Kruskal-Wallis|||Comparison of Rigors among arms.|
1750601|NCT00343382|3216350|Superiority or Other|||||||0.5974|||||||Kruskal-Wallis||||
1750602|NCT00343382|3216350|Superiority or Other|||||||0.1675|||||||Kruskal-Wallis||||
1750603|NCT00343252|3216356|Superiority or Other|||||||0.553|||||||ANCOVA||||
1750604|NCT00343252|3216357|Superiority or Other|||||||0.943|||||||ANCOVA||||
1750605|NCT00343252|3216358|Superiority or Other||Hazard Ratio (HR)|1.09||||0.353|2-Sided|95.0|0.91|1.3|||Log Rank||||
1750606|NCT00343252|3216359|Superiority or Other||Hazard Ratio (HR)|1.07||||0.453|2-Sided|95.0|0.89|1.28|||Log Rank||||
1751343|NCT00327717|3217921|Superiority or Other|||||||0.044|||||||X^2 test||||
1750609|NCT00343252|3216364|Superiority or Other|||||||0.572||||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 12-month endpoint.|
1750610|NCT00343252|3216365|Superiority or Other|||||||0.814||||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 6-month endpoint.|
1750611|NCT00343252|3216366|Superiority or Other|||||||0.932||||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 12-month endpoint.|
1750612|NCT00343252|3216367|Superiority or Other|||||||0.568||||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 6-month endpoint.|
1750613|NCT00343252|3216368|Superiority or Other|||||||0.968||||||No adjustments for multiplicity were performed.|ANCOVA|The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.||Tested the null hypothesis that there is no statistically significant difference between the treatment groups in the proportion of participants with a reduction in disability at the 3-month endpoint.|
1750614|NCT00343252|3216369|Superiority or Other||Hazard Ratio (HR)|1.02||||0.789|2-Sided|95.0|0.86|1.23||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a >=30% reduction in average back pain at the 12-month endpoint.|
1750615|NCT00343252|3216370|Superiority or Other||Hazard Ratio (HR)|1.04||||0.681|2-Sided|95.0|0.86|1.26||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a >=30% reduction for average back pain at the 6-month endpoint.|
1750616|NCT00343252|3216371|Superiority or Other||Hazard Ratio (HR)|1.03||||0.719|2-Sided|95.0|0.86|1.25||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a >=30% reduction in worst back pain at the 12-month endpoint.|
1750617|NCT00343252|3216372|Superiority or Other||Hazard Ratio (HR)|1.03||||0.746|2-Sided|95.0|0.85|1.26||Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.|Log Rank|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a >=30% reduction in worst back pain at the 6-month endpoint.|
1750618|NCT00343252|3216373|Superiority or Other|||||||0.986||||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month endpoint.|
1750619|NCT00343252|3216374|Superiority or Other|||||||0.809||||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month endpoint.|
1750620|NCT00343252|3216375|Superiority or Other|||||||0.683||||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline at the 12-month endpoint.|
1750621|NCT00343252|3216376|Superiority or Other|||||||0.642||||||All comparisons were conducted using a 2-sided significance level of 0.05.|Chi-square|No adjustments for multiplicity were performed.||Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month endpoint.|
1750622|NCT00343044|3216385|Superiority or Other|||||||0.02||||||Standard statistical methods (log-rank tests) were used in post hoc analyses that compared efficacy parameters in patients who received 1 vs 2 prior treatment regimens.|Log Rank|||Overall survival(OS)was estimated using the Kaplan-Meier method.|
1750623|NCT00343044|3216386|Superiority or Other|||||||0.08||||||Standard statistical methods (log-rank tests) were used in post hoc analyses that compared efficacy parameters in patients who received 1 vs 2 prior treatment regimens.|Log Rank|||Planned enrollment of 40 patients was determined assuming a median progression free survival (PFS) of 9 months (based on a median PFS of 7.2 months for low-dose, metronomic cyclophosphamide plus bevacizumab in a phase 2 study) and an analysis calculating the sample size at which the narrowing of its 95% confidence interval (CI) became greater than .2 for every 2 patients added. Progression free survival was estimated using the Kaplan-Meier method.|
1750624|NCT00340704|3216410|Superiority or Other||Slope|0.98|Standard Error of the Mean|0.1884||||95.0|0.5934|1.3666|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error of the mean is actually standard error of the slope.|Dose proportionality for AUCτ,ss was explored based on the regression model.|
1750625|NCT00340704|3216414|Superiority or Other||Slope|1.0039|Standard Error of the Mean|0.1725||||95.0|0.6499|1.3579|||||Based on the estimate for the slope parameter, a two sided 95% confidence interval for the slope was computed. Perfect dose proportionality would correspond to a slope of 1. Standard error (SE) of the mean is actually SE of the slope.|Dose proportionality for Cmax,ss was explored based on the regression model.|
1750626|NCT00339183|3216441|Superiority or Other||Odds Ratio (OR)|1.0||||1|2-Sided|95.0|0.56|1.76|||Stratified exact test|Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.||
1750627|NCT00339183|3216441|Superiority or Other||Odds Ratio (OR)|5.33|||<|0.0001|2-Sided|95.0|3.21|8.6|||Stratified exact test|Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.|The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.||
1750628|NCT00339183|3216442|Superiority or Other||Normal score|-0.6||||0.5503|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score <0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.|The treatment effect on OS in the Mutant KRAS Efficacy Analysis Set was compared at the 4% level conditional on first demonstrating a significant OS treatment effect in the Wild-type KRAS Efficacy Analysis Set.|
1750629|NCT00339183|3216442|Superiority or Other||Normal score|-1.57||||0.1154|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score <0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer overall survival time.|An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.|
1750630|NCT00339183|3216443|Superiority or Other||Normal score|-1.46||||0.1448|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure and prior oxaliplatin exposure (yes or no).|A normal score <0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.|PFS in the Mutant Efficacy Analysis Set was compared at a 1% level conditional upon first demonstrating a significant difference in PFS in the Wild-type KRAS Efficacy Analysis Set.|
1750631|NCT00339183|3216443|Superiority or Other||Normal score|-2.91||||0.0036|||||||Stratified log-rank test|P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).|A normal score <0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.|An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.|
1750632|NCT00339040|3216479|Superiority or Other|||||||1|||||||Fisher Exact||||
1750633|NCT00338962|3216481|Superiority or Other|||||||0.007|||||||ANOVA|||Gastrointestinal symptoms compared|
1750634|NCT00338962|3216483|Superiority or Other|||||||0||||||Bonferonni adjustments were applied. Mixed effects models were used to assess changes in PTSD symptoms over time.|Mixed Models Analysis|F=49.633|||
1750635|NCT00338884|3216487|Superiority or Other|||||||0.8263|||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750636|NCT00338884|3216487|Superiority or Other|||||||0.3731|||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750637|NCT00338884|3216487|Superiority or Other|||||||0.6249|||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750638|NCT00338884|3216487|Superiority or Other|||||||0.9595|||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750639|NCT00338884|3216487|Superiority or Other|||||||0.4013|||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750640|NCT00338884|3216487|Superiority or Other|||||||0.9437|||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750641|NCT00338884|3216487|Superiority or Other|||||||0.5162|||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750642|NCT00338884|3216487|Superiority or Other|||||||0.8204|||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750643|NCT00338884|3216487|Superiority or Other|||||||0.1701|||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750644|NCT00338884|3216487|Superiority or Other|||||||0.4632|||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750645|NCT00338884|3216488|Superiority or Other|||||||0.6397|||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)|
1750646|NCT00338884|3216488|Superiority or Other|||||||0.3495|||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)|
1750647|NCT00338884|3216488|Superiority or Other|||||||0.5465|||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)|
1750648|NCT00338884|3216488|Superiority or Other|||||||0.8162|||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)|
1750649|NCT00338884|3216488|Superiority or Other|||||||0.4703|||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)|
1750650|NCT00338884|3216488|Superiority or Other|||||||0.747|||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)|
1750651|NCT00338884|3216488|Superiority or Other|||||||0.5748|||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)|
1750652|NCT00338884|3216488|Superiority or Other|||||||0.7037|||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)|
1750653|NCT00338884|3216488|Superiority or Other|||||||0.1949|||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)|
1750654|NCT00338884|3216488|Superiority or Other|||||||0.3386|||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)|
1750655|NCT00338884|3216490|Superiority or Other|||||||0.1087|||||||Wilcoxon Rank Sum Test|||CR or PR or (SD > = 12 Weeks) Versus PD|
1750656|NCT00338884|3216491|Superiority or Other|||||||0.0292|||||||Wilcoxon Rank Sum Test|||CR or PR Versus PD|
1750657|NCT00338884|3216493|Superiority or Other|||||||0.3731|||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750658|NCT00338884|3216493|Superiority or Other|||||||0.8481|||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750659|NCT00338884|3216493|Superiority or Other|||||||0.6382|||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750660|NCT00338884|3216493|Superiority or Other|||||||0.6709|||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750661|NCT00338884|3216493|Superiority or Other|||||||0.2369|||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750662|NCT00338884|3216493|Superiority or Other|||||||0.4896|||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750663|NCT00338884|3216493|Superiority or Other|||||||0.112|||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750664|NCT00338884|3216493|Superiority or Other|||||||0.4572|||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750665|NCT00338884|3216493|Superiority or Other|||||||0.5871|||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750666|NCT00338884|3216493|Superiority or Other|||||||0.6939|||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750667|NCT00338884|3216494|Superiority or Other|||||||0.592|||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)|
1750668|NCT00338884|3216494|Superiority or Other|||||||0.8679|||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)|
1750669|NCT00338884|3216494|Superiority or Other|||||||0.6333|||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)|
1750670|NCT00338884|3216494|Superiority or Other|||||||1|||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)|
1750671|NCT00338884|3216494|Superiority or Other|||||||0.3795|||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)|
1750672|NCT00338884|3216494|Superiority or Other|||||||0.4187|||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)|
1750673|NCT00338884|3216494|Superiority or Other|||||||0.1933|||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)|
1750674|NCT00338884|3216494|Superiority or Other|||||||0.4757|||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)|
1750675|NCT00338884|3216494|Superiority or Other|||||||0.5879|||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)|
1750676|NCT00338884|3216494|Superiority or Other|||||||0.8519|||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)|
1750677|NCT00338884|3216496|Superiority or Other|||||||0.1159|||||||Wilcoxon Rank Sum Test|||CR or PR or (SD > = 12 Weeks) Versus PD|
1750678|NCT00338884|3216497|Superiority or Other|||||||0.068|||||||Wilcoxon Rank Sum Test|||CR or PR Versus PD|
1750679|NCT00338884|3216500|Superiority or Other|||||||0.2179|||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750680|NCT00338884|3216500|Superiority or Other|||||||0.335|||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750681|NCT00338884|3216500|Superiority or Other|||||||0.98|||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750682|NCT00338884|3216500|Superiority or Other|||||||0.3391|||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750683|NCT00338884|3216500|Superiority or Other|||||||0.3659|||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750684|NCT00338884|3216500|Superiority or Other|||||||0.2703|||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750685|NCT00338884|3216500|Superiority or Other|||||||0.174|||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750686|NCT00338884|3216500|Superiority or Other|||||||0.045|||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750687|NCT00338884|3216500|Superiority or Other|||||||0.6867|||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750688|NCT00338884|3216500|Superiority or Other|||||||0.8286|||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750689|NCT00338884|3216500|Superiority or Other|||||||0.7267|||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750690|NCT00338884|3216501|Superiority or Other|||||||0.2703|||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)|
1750691|NCT00338884|3216501|Superiority or Other|||||||0.407|||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)|
1750692|NCT00338884|3216501|Superiority or Other|||||||0.9278|||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)|
1750693|NCT00338884|3216501|Superiority or Other|||||||0.3133|||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)|
1750694|NCT00338884|3216501|Superiority or Other|||||||0.5091|||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)|
1750695|NCT00338884|3216501|Superiority or Other|||||||0.2548|||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)|
1750696|NCT00338884|3216501|Superiority or Other|||||||0.4051|||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)|
1750697|NCT00338884|3216501|Superiority or Other|||||||0.0513|||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)|
1750698|NCT00338884|3216501|Superiority or Other|||||||0.8519|||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)|
1750699|NCT00338884|3216501|Superiority or Other|||||||0.9625|||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)|
1750700|NCT00338884|3216501|Superiority or Other|||||||0.5784|||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)|
1750701|NCT00338884|3216503|Superiority or Other|||||||0.2179|||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750702|NCT00338884|3216503|Superiority or Other|||||||0.9759|||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750703|NCT00338884|3216503|Superiority or Other|||||||0.2229|||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1751166|NCT00332163|3217137|Superiority or Other||Difference|0.0|||||2-Sided|95.0|-10.0|10.0|||||Difference = Pre-emptive – Reactive||
1750704|NCT00338884|3216503|Superiority or Other|||||||0.3637|||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750705|NCT00338884|3216503|Superiority or Other|||||||0.546|||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750706|NCT00338884|3216503|Superiority or Other|||||||0.3628|||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750707|NCT00338884|3216503|Superiority or Other|||||||0.4779|||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750708|NCT00338884|3216503|Superiority or Other|||||||0.2074|||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750709|NCT00338884|3216503|Superiority or Other|||||||0.2259|||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750710|NCT00338884|3216503|Superiority or Other|||||||0.8555|||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750711|NCT00338884|3216503|Superiority or Other|||||||0.7267|||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750712|NCT00338884|3216504|Superiority or Other|||||||0.2702|||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)|
1750713|NCT00338884|3216504|Superiority or Other|||||||0.8758|||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)|
1750714|NCT00338884|3216504|Superiority or Other|||||||0.2809|||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)|
1750715|NCT00338884|3216504|Superiority or Other|||||||0.3566|||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)|
1750716|NCT00338884|3216504|Superiority or Other|||||||0.7575|||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)|
1750717|NCT00338884|3216504|Superiority or Other|||||||0.462|||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)|
1750718|NCT00338884|3216504|Superiority or Other|||||||0.8627|||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)|
1750719|NCT00338884|3216504|Superiority or Other|||||||0.2782|||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)|
1750720|NCT00338884|3216504|Superiority or Other|||||||0.1639|||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)|
1750721|NCT00338884|3216504|Superiority or Other|||||||0.6251|||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)|
1750722|NCT00338884|3216504|Superiority or Other|||||||0.5784|||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)|
1750723|NCT00338884|3216506|Superiority or Other|||||||0.2409|||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750724|NCT00338884|3216506|Superiority or Other|||||||0.292|||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750725|NCT00338884|3216506|Superiority or Other|||||||0.3069|||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750726|NCT00338884|3216506|Superiority or Other|||||||0.4161|||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750727|NCT00338884|3216506|Superiority or Other|||||||0.3018|||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750728|NCT00338884|3216506|Superiority or Other|||||||0.2873|||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750729|NCT00338884|3216506|Superiority or Other|||||||0.0927|||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750730|NCT00338884|3216506|Superiority or Other|||||||0.03|||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750731|NCT00338884|3216506|Superiority or Other|||||||0.9608|||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750732|NCT00338884|3216506|Superiority or Other|||||||0.6263|||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750733|NCT00338884|3216506|Superiority or Other|||||||0.7154|||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR or [SD > = 12 Weeks] Versus PD)|
1750734|NCT00338884|3216507|Superiority or Other|||||||0.2702|||||||Wilcoxon Rank Sum Test|||Day 1, Week 33 (CR or PR Versus PD)|
1750735|NCT00338884|3216507|Superiority or Other|||||||0.3259|||||||Wilcoxon Rank Sum Test|||Day 1, Week 29 (CR or PR Versus PD)|
1750736|NCT00338884|3216507|Superiority or Other|||||||0.2809|||||||Wilcoxon Rank Sum Test|||Day 1, Week 25 (CR or PR Versus PD)|
1750737|NCT00338884|3216507|Superiority or Other|||||||0.4547|||||||Wilcoxon Rank Sum Test|||Day 1, Week 21 (CR or PR Versus PD)|
1750738|NCT00338884|3216507|Superiority or Other|||||||0.3567|||||||Wilcoxon Rank Sum Test|||Day 1, Week 17 (CR or PR Versus PD)|
1750739|NCT00338884|3216507|Superiority or Other|||||||0.2898|||||||Wilcoxon Rank Sum Test|||Day 1, Week 13 (CR or PR Versus PD)|
1750740|NCT00338884|3216507|Superiority or Other|||||||0.1988|||||||Wilcoxon Rank Sum Test|||Day 1, Week 9 (CR or PR Versus PD)|
1750741|NCT00338884|3216507|Superiority or Other|||||||0.0278|||||||Wilcoxon Rank Sum Test|||Day 1, Week 7 (CR or PR Versus PD)|
1750742|NCT00338884|3216507|Superiority or Other|||||||0.8366|||||||Wilcoxon Rank Sum Test|||Day 1, Week 5 (CR or PR Versus PD)|
1750743|NCT00338884|3216507|Superiority or Other|||||||0.7635|||||||Wilcoxon Rank Sum Test|||Day 1, Week 3 (CR or PR Versus PD)|
1750744|NCT00338884|3216507|Superiority or Other|||||||0.5581|||||||Wilcoxon Rank Sum Test|||Day 1, Week 1 (CR or PR Versus PD)|
1750745|NCT00338884|3216513|Superiority or Other||Objective Response Rate (ORR) (percent)|35.3|||||2-Sided|95.0|26.7|44.8|||||ORR=proportion of subjects with confirmed CR or PR, relative to total subjects who received at least 1 dose of study medication, had a baseline disease assessment, and had the correct histological cancer type.||
1750746|NCT00337935|3216569|Superiority or Other||||||<|0.0001||||||A priori threshold for statistical significance p=0.05|Log Rank||||
1750747|NCT00337935|3216570|Superiority or Other||||||<|0.001||||||A priori threshold for statistical significance p=0.05|Chi-squared||||
1750748|NCT00337935|3216571|Superiority or Other||Mean Difference (Net)|0.6|Standard Error of the Mean|0.2||0.0062|2-Sided|95.0|0.2|0.9||a priori theshold for statistical significance was p=0.05|ANCOVA|Baseline Hemoglobin was used as a covariate.|||
1751167|NCT00332163|3217138|Superiority or Other||Difference|-4.0|||||2-Sided|95.0|-16.0|7.0|||||Difference = Pre-emptive - Reactive||
1750749|NCT00337779|3216579|Superiority or Other||Risk Ratio (RR)|1.0732|Standard Error of the Mean|0.1013||0.4859|2-Sided|95.0|0.8799|1.309|||Regression, Poisson||980 subjects randomized into two arms provide approximately 90% power to detect significant difference between groups of 30% or more in rate of confirmed relapses.||
1750750|NCT00337727|3216580|Superiority or Other||||||<|0.01||||||Superiority based on 2-sided level of significance of 0.05, based on a logistic regression model that included terms for treatment group, region and gender.|Regression, Logistic||||
1750751|NCT00337727|3216581|Superiority or Other||||||<|0.01||||||Superiority based on 2-sided level of significance of 0.05, based on a logistic regression model that included terms for treatment group, region and gender.|Regression, Logistic||||
1750752|NCT00337675|3216582|Superiority or Other||Least-Squares Mean Difference|-0.11|Standard Error of the Mean|0.06||0.061||95.0|-0.23|0.0||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the family of secondary endpoints, adjustment for multiplicity was performed using Hochberg’s method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or [intermittent and daily regimens]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.|
1750753|NCT00337675|3216582|Superiority or Other||Least-Squares Mean Difference|-0.12|Standard Error of the Mean|0.06||0.045||95.0|-0.24|0.0||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the family of secondary endpoints, adjustment for multiplicity was performed using Hochberg’s method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or [intermittent and daily regimens]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.|
1750754|NCT00337675|3216583|Superiority or Other||Least-Squares Mean Difference|-0.17|Standard Error of the Mean|0.14||0.202||95.0|-0.44|0.09||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the 2 endpoints assessing severity, adjustment for multiplicity was performed using Hochberg’s method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or [intermittent and daily regimens]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.|
1750755|NCT00337675|3216583|Superiority or Other||Least-Squares Mean Difference|-0.19|Standard Error of the Mean|0.14||0.176||95.0|-0.46|0.09||Multiplicity adjustment across regimens and across primary and secondary endpoints was addressed through step-down testing. Within the 2 endpoints assessing severity, adjustment for multiplicity was performed using Hochberg’s method.|ANOVA|An ANOVA model containing factors for treatment, age group, and geographical region was used.||The secondary hypothesis stated that montelukast (daily regimen, or [intermittent and daily regimens]), compared with placebo, results in improvement of respiratory symptoms assessed over 3 days prior to asthma attacks, or assessed over the 12-day treatment period of asthma episodes in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year.|
1750756|NCT00337675|3216584|Superiority or Other||Rate reduction|-1.2|Standard Error of the Mean|7.8||0.884||95.0|-19.2|14.0||Multiplicity adjustment across regimens was addressed through step-down testing. Daily montelukast versus placebo was tested first; if this comparison was significant, intermittent montelukast versus placebo was tested. The significance level was 5%.|Regression, Poisson|A Poisson regression model containing factors for treatment, age group, and geographic region, and an offset for number of days in study was used.|Rate reduction = (1 - montelukast-adjusted annual rate/placebo-adjusted annual rate) x 100%|The primary hypothesis stated that montelukast (daily regimen, or [intermittent and daily regimens]), compared with placebo, results in a decrease in the number of asthma episodes culminating in asthma attack in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. A sample size of 450 evaluable patients per arm allowed the detection of a difference in rate of 23% with 90% power.|
1750757|NCT00337675|3216584|Superiority or Other||Rate reduction|5.3|Standard Error of the Mean|7.3||0.51||95.0|-11.4|19.6||Multiplicity adjustment across regimens was addressed through step-down testing. Daily montelukast versus placebo was tested first; if this comparison was significant, intermittent montelukast versus placebo was tested. The significance level was 5%.|Regression, Poisson|A Poisson regression model containing factors for treatment, age group, and geographic region, and an offset for number of days in study was used.|Rate reduction = (1 - montelukast-adjusted annual rate/placebo-adjusted annual rate) x 100%|The primary hypothesis stated that montelukast (daily regimen, or [intermittent and daily regimens]), compared with placebo, results in a decrease in the number of asthma episodes culminating in asthma attack in pediatric patients aged 6 months to 5 years with episodic asthma and treated over 1 year. A sample size of 450 evaluable patients per arm allowed the detection of a difference in rate of 23% with 90% power.|
1750758|NCT00337662|3216585|Superiority or Other|||||||0.143||||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA||||
1750759|NCT00337662|3216585|Superiority or Other|||||||0.026||||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA||||
1750760|NCT00337662|3216586|Superiority or Other|||||||0.386||||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA||||
1750761|NCT00337662|3216586|Superiority or Other|||||||0.544||||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA||||
1750762|NCT00337662|3216587|Superiority or Other|||||||0.411||||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA||||
1750763|NCT00337662|3216587|Superiority or Other|||||||0.209||||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA||||
1750764|NCT00337662|3216588|Superiority or Other|||||||0.259||||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA||||
1750765|NCT00337662|3216588|Superiority or Other|||||||0.291||||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA||||
1750766|NCT00337662|3216589|Superiority or Other|||||||0.299|||||||ANOVA|P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|||
1750767|NCT00337662|3216589|Superiority or Other|||||||0.254||||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA||||
1750768|NCT00337662|3216590|Superiority or Other|||||||0.181||||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA||||
1750769|NCT00337662|3216590|Superiority or Other|||||||0.14||||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA||||
1750770|NCT00337662|3216591|Superiority or Other|||||||0.015|||||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.|||
1750771|NCT00337662|3216591|Superiority or Other|||||||0.266|||||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.|||
1750772|NCT00337662|3216592|Superiority or Other|||||||0.505|||||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.|||
1750773|NCT00337662|3216592|Superiority or Other|||||||0.998|||||||ANOVA|P-value is from ANOVA with treatment and pooled investigator in the model.|||
1750774|NCT00337662|3216593|Superiority or Other|||||||0.244|||||||ANOVA|p-value is from ANOVA with treatment and pooled investigator in the model.|||
1750775|NCT00337662|3216593|Superiority or Other|||||||0.355|||||||ANOVA|p-value is from ANOVA with treatment and pooled investigator in the model.|||
1750776|NCT00337662|3216594|Superiority or Other||||||>|0.05||||||All comparisons between EO-RIS and NEO-RIS and between NEO-RIS and NEO-OLZ had p-values greater than 0.05.|Fisher Exact||||
1750777|NCT00337662|3216595|Superiority or Other|||||||0.125||||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA||||
1750778|NCT00337662|3216595|Superiority or Other|||||||0.034||||||P-values (Change from Baseline) are based on Type III sums of squares from ANOVA model: change = group pooled investigator.|ANOVA||||
1750779|NCT00337662|3216596|Superiority or Other|||||||0.474|||||||Fisher Exact||||
1750780|NCT00337662|3216597|Superiority or Other|||||||0.745|||||||Fisher Exact||||
1750781|NCT00337662|3216598|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1750782|NCT00337662|3216599|Superiority or Other|||||||0.604|||||||Fisher Exact||||
1750783|NCT00337662|3216600|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1750784|NCT00337662|3216601|Superiority or Other|||||||0.02||||||Change from Week 2 to Week 12 p-value|Mixed-Effects Model Repeated-Measures||||
1750785|NCT00337662|3216601|Superiority or Other|||||||0.216||||||Change from Week 2 to Week 8 p-value|Mixed-Effects Model Repeated-Measures||||
1750786|NCT00337662|3216601|Superiority or Other|||||||0.151||||||Change from Week 2 to Week 6 p-value|Mixed-Effects Model Repeated-Measures||||
1750787|NCT00337662|3216601|Superiority or Other|||||||0.884||||||Change from Week 2 to Week 4 p-value|Mixed-Effects Model Repeated-Measures||||
1750788|NCT00337662|3216601|Superiority or Other|||||||0.266||||||Change from Week 2 to Week 3 p-value|Mixed-Effects Model Repeated-Measures||||
1750789|NCT00337662|3216602|Superiority or Other||||||<|0.001||||||Between-group p-values for each baseline to post-baseline visit were the same, p<0.001.|Mixed Effects Model Repeated Measures||||
1750790|NCT00337610|3216603|Superiority or Other||Mean Difference (Net)|-1.01|Standard Deviation|1.34|<|0.001||95.0|-1.4|-0.62|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)|||
1750791|NCT00337610|3216604|Superiority or Other||Mean Difference (Net)|-54.1|Standard Deviation|63.8|<|0.001||95.0|-74.7|-33.6|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)|||
1750792|NCT00337610|3216605|Superiority or Other||Mean Difference (Net)|-25.5|Standard Deviation|42.2|<|0.001||95.0|-37.7|-13.3|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic medication (on Monotherapy AHA or on Metformin-based combination therapy)|||
1750793|NCT00337610|3216606|Superiority or Other||Mean Difference (Net)|-1.02|Standard Deviation|1.19|<|0.001||95.0|-1.36|-0.67|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic agent (AHA) [medication] (on Monotherapy AHA or on Metformin-based combination therapy)|||
1750794|NCT00337467|3216617|Superiority or Other||Mean Change|16.0|Standard Error of the Mean|12.5|||2-Sided|95.0|-9.5|41.6||||||Percent Change from Baseline in Fasting Triglycerides at Week 96|
1750795|NCT00337467|3216617|Superiority or Other||Mean Change|29.0|Standard Error of the Mean|6.5|||2-Sided|95.0|15.3|42.0||||||Percent Change from Baseline in Fasting LDL Cholesterol at Week 96|
1750796|NCT00337467|3216617|Superiority or Other||Mean Change|19.0|Standard Error of the Mean|4.4|||2-Sided|95.0|10.3|28.4||||||Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 96|
1750797|NCT00337467|3216617|Superiority or Other||Mean Change|2.0|Standard Error of the Mean|3.9|||2-Sided|95.0|-6.0|10.2||||||Percent Change from Baseline in Fasting HDL Cholesterol at Week 96|
1750798|NCT00337467|3216617|Superiority or Other||Mean Change|14.0|Standard Error of the Mean|3.2||||95.0|6.9|20.1||||||Percent Change from Baseline in Fasting Total Cholesterol at Week 96|
1750799|NCT00337467|3216618|Superiority or Other||Mean Change|17.0|Standard Error of the Mean|8.6|||2-Sided|95.0|-0.4|34.4||||||Percent Change from Baseline in Fasting Triglycerides at Week 48|
1750800|NCT00337467|3216618|Superiority or Other||Mean Change|20.0|Standard Error of the Mean|5.8|||2-Sided|95.0|8.0|31.7||||||Percent Change from Baseline in Fasting LDL Cholesterol at Week 48|
1750801|NCT00337467|3216618|Superiority or Other||Mean Change|12.0|Standard Error of the Mean|4.1|||2-Sided|95.0|4.0|20.8||||||Percent Change from Baseline in Fasting Non-HDL Cholesterol at Week 48|
1751344|NCT00327717|3217922|Superiority or Other|||||||0.516|||||||ANOVA||||
1751345|NCT00327717|3217923|Superiority or Other|||||||0.211|||||||ANOVA||||
1750802|NCT00337467|3216618|Superiority or Other||Mean Change|2.0|Standard Error of the Mean|3.1|||2-Sided|95.0|-3.9|8.8||||||Percent Change from Baseline in Fasting HDL Cholesterol at Week 48|
1750803|NCT00337467|3216618|Superiority or Other||Mean Change|9.0|Standard Error of the Mean|3.0|||2-Sided|95.0|2.5|14.6||||||Percent Change from Baseline in Fasting Total Cholesterol at Week 48|
1750804|NCT00337467|3216620|Superiority or Other||Mean Change (Final Values)|63.0|Standard Error of the Mean|32.9|||2-Sided|95.0|-4.0|129.1|||||||
1750805|NCT00337467|3216621|Superiority or Other||Mean Change (Final Values)|53.0|Standard Error of the Mean|30.0|||2-Sided|95.0|-7.1|113.7|||||||
1750806|NCT00337467|3216622|Superiority or Other||Mean Change (Final Values)|61.0|Standard Error of the Mean|24.3|||2-Sided|95.0|12.3|109.8|||||||
1750807|NCT00337467|3216627|Superiority or Other||Percentage of Participants|34.4|||||2-Sided|95.0|22.7|47.7|||||||
1750808|NCT00337467|3216628|Superiority or Other||Percentage of Participants|21.3|||||2-Sided|95.0|11.9|33.7|||||||
1750809|NCT00337428|3216629|Non-Inferiority or Equivalence|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1750810|NCT00337428|3216630|Non-Inferiority or Equivalence|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1750811|NCT00337428|3216631|Non-Inferiority or Equivalence|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1750812|NCT00337428|3216632|Non-Inferiority or Equivalence|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.67.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1750813|NCT00337428|3216633|Non-Inferiority or Equivalence|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26|||
1750814|NCT00337428|3216634|Non-Inferiority or Equivalence|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26|||
1750815|NCT00337428|3216635|Non-Inferiority or Equivalence|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26|||
1750816|NCT00337428|3216636|Non-Inferiority or Equivalence|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26|||
1750817|NCT00337428|3216637|Non-Inferiority or Equivalence|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -10%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26|||
1750818|NCT00337428|3216638|Non-Inferiority or Equivalence|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26|||
1750819|NCT00337428|3216639|Non-Inferiority or Equivalence|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26|||
1750820|NCT00337428|3216640|Non-Inferiority or Equivalence|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26|||
1750821|NCT00337428|3216641|Non-Inferiority or Equivalence|The difference in seroconversion rates (concomitant group - nonconcomitant group) must be greater than -5%|||||<|0.001|||||||Miettinen and Nurminen|Miettinen and Nurminen method for difference in proportions; Stat Med 1985;4:213-26|||
1750822|NCT00337428|3216642|Non-Inferiority or Equivalence|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1750823|NCT00337428|3216643|Non-Inferiority or Equivalence|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1750824|NCT00337428|3216644|Non-Inferiority or Equivalence|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1750825|NCT00337428|3216645|Non-Inferiority or Equivalence|The ratio of GMTs (concomitant group / nonconcomitant group) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1750826|NCT00337350|3216646|Superiority or Other|||||||0.21|||||||ANCOVA||||
1750827|NCT00337350|3216647|Superiority or Other|||||||0.05|||||||ANCOVA||||
1750828|NCT00337350|3216648|Superiority or Other|||||||0.08|||||||ANCOVA||||
1750829|NCT00337285|3216649|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1750830|NCT00337285|3216651|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1750831|NCT00337194|3216663|Superiority or Other|||||||1|||||||Fisher Exact||||
1750832|NCT00337194|3216664|Superiority or Other|||||||0.06|||||||Chi-squared||||
1750833|NCT00337129|3216677|Superiority or Other||Response probability|0.05|||||2-Sided|95.0|0.01|0.17||||||Null hypothesis: response probability < 5%; alternative hypothesis: response probability > 20%. A two-stage design was used. If no responses among the first 20 patients, the study would be terminated with the conclusion that E7389 is inactive. However, if at least one response was seen then an additional 20 patients would be accrued. Five or more responses out of 40 would be considered evidence that E7389 warranted further study. This design had a significance level of 5% and a power of 92%.|
1750834|NCT00336544|3216714|Non-Inferiority or Equivalence|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|-4.4||||0.0775||95.0|-9.1|0.3|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin –Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.|
1750835|NCT00336544|3216716|Non-Inferiority or Equivalence|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|-5.7||||0.0769||95.0|-11.9|0.6|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin –Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.|
1750836|NCT00336505|3216718|Non-Inferiority or Equivalence|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|0.3|||>|0.9999||95.0|-4.5|5.1|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin –Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.|
1750837|NCT00336505|3216720|Non-Inferiority or Equivalence|Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)|Mean Difference (Net)|2.0||||0.5667|2-Sided|95.0|-4.8|8.9|||Fisher Exact|||The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin –Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.|
1750838|NCT00336492|3216721|Superiority or Other|||||||0.146|||||||Chi-squared||||
1750839|NCT00336479|3216726|Superiority or Other||Odds Ratio (OR)|1.976||||0.0418|2-Sided|95.0|1.026|3.807|||Regression, Logistic||||
1750840|NCT00336479|3216726|Superiority or Other||Odds Ratio (OR)|2.586||||0.0051|2-Sided|95.0|1.331|5.025|||Regression, Logistic||||
1750841|NCT00336479|3216727|Superiority or Other||Odds Ratio (OR)|2.17||||0.0204|2-Sided|95.0|1.127|4.178|||Regression, Logistic||||
1750842|NCT00336479|3216727|Superiority or Other||Odds Ratio (OR)|2.985||||0.0014|2-Sided|95.0|1.525|5.842|||Regression, Logistic|Treatment, weight, race and baseline HCV RNA as factors|||
1750843|NCT00336323|3216740|Superiority or Other|||||||0.06|||||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline subretinal fluid presence that was definite/questionable compared to eyes that there was no evidence of subretinal fluid at baseline. Eyes included all of those from the pooled Bevacizumab group.|
1750844|NCT00336323|3216741|Superiority or Other|||||||0.45|||||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline clinical diabetic macular edema (DME) characterization of typical/predominantly focal compared to neither predominantly focal or diffuse characterization at baseline and compared to typical/predominantly diffuse characterization at baseline. Eyes included all of those from the pooled Bevacizumab group.|
1750845|NCT00336323|3216742|Superiority or Other|||||||0.38|||||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline retinopathy severity of <severe nonproliferative diabetic retinopathy (NPDR) compared to eyes that had baseline retinopathy severity of proliferative diabetic retinopathy or severe NPDR. Eyes included all of those from the pooled Bevacizumab group.|
1750846|NCT00336323|3216743|Superiority or Other|||||||0.04|||||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that did not have a prior history of treatment for diabetic macular edema compared to eyes that did have a prior history of treatment for diabetic macular edema. Eyes included all of those from the pooled Bevacizumab group.|
1750847|NCT00336323|3216744|Superiority or Other|||||||0.37|||||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between females and males. Eyes included all of those from the pooled Bevacizumab group.|
1750848|NCT00336323|3216745|Superiority or Other|||||||0.23|||||||Least squares regression|||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that were ≤66 years old at baseline compared to eyes that were >66 years old at baseline. Eyes included all of those from the pooled Bevacizumab group.|
1750849|NCT00336323|3216746|Superiority or Other|||||||0.006|||||||Least squares regression|Adjusted for baseline values||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had a baseline visual acuity letter score of <65 letters compared to eyes that had baseline visual acuity letter score of ≥65 letters. Eyes included all of those from the pooled Bevacizumab group.|
1750870|NCT00336323|3216759|Superiority or Other||||||<|0.009|||||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness at the 3 week visit between the laser only treatment group to the 1.25 mg injection at baseline and at 6 weeks treatment group|
1750850|NCT00336323|3216747|Superiority or Other|||||||0.22|||||||Least squares regression|Adjusted for baseline values||Comparison of change in visual acuity letter score from baseline to the 3 week visit between eyes that had baseline central subfield thickness of <400 microns compared to eyes that had baseline central subfield thickness of ≥400 microns. Eyes included all of those from the pooled Bevacizumab group.|
1750851|NCT00336323|3216748|Superiority or Other|||||||0.52|||||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline subretinal fluid that was definite/questionable compared to eyes that had no evidence of subretinal fluid at baseline. Eyes included all of those from the pooled Bevacizumab group.|
1750852|NCT00336323|3216749|Superiority or Other|||||||0.93|||||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline clinical diabetic macular edema characterized as typical/predominantly focal, neither predominantly focal or diffuse, or typical/predominantly diffuse. Eyes included all of those from the pooled Bevacizumab group.|
1750853|NCT00336323|3216750|Superiority or Other|||||||0.53|||||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline retinopathy severity that was <severe nonproliferative diabetic retinopathy (NPDR) compared to those that had baseline retinopathy severity that was proliferative diabetic retinopathy or severe NPDR. Eyes included all of those from the pooled Bevacizumab group.|
1750854|NCT00336323|3216751|Superiority or Other|||||||0.16|||||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had no history of treatment for diabetic macular edema compared to those that had history or treatment for diabetic macular edema. Eyes included all of those from the pooled Bevacizumab group.|
1750855|NCT00336323|3216752|Superiority or Other|||||||0.55|||||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between females and males. Eyes included all of those from the pooled Bevacizumab group.|
1750856|NCT00336323|3216753|Superiority or Other|||||||0.44|||||||Least squares regression|||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between those that were ≤66 years old compared to those that were >66 years old at baseline. Eyes included all of those from the pooled Bevacizumab group.|
1750857|NCT00336323|3216754|Superiority or Other|||||||0.31|||||||Least squares regression|Adjusted for baseline score||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline visual acuity letter score that was <65 letters compared to those that had baseline visual acuity letter score that was ≥65 letters. Eyes included all of those from the pooled Bevacizumab group.|
1750858|NCT00336323|3216755|Superiority or Other||||||<|0.0001|||||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness (microns) change from baseline to the 3 week visit between eyes that had baseline central subfield thickness of <400 microns compared to those that had baseline central subfield thickness of ≥400 microns. Eyes included all of those from the pooled Bevacizumab group.|
1750859|NCT00336323|3216758|Superiority or Other|||||||0.003|||||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity through the 12 week visit between the laser only treatment group and the 2.5mg injection at baseline and at 6 weeks treatment group|
1750860|NCT00336323|3216758|Superiority or Other|||||||0.01|||||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity through the 12 week visit between the laser only treatment group and the 1.25mg injection at baseline and at 6 weeks treatment group|
1750861|NCT00336323|3216758|Superiority or Other|||||||0.82|||||||Least squares regression|||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 12 week visit|
1750862|NCT00336323|3216758|Superiority or Other|||||||0.48|||||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 9 week visit|
1750863|NCT00336323|3216758|Superiority or Other|||||||0.67|||||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 6 week visit|
1750864|NCT00336323|3216758|Superiority or Other|||||||0.42|||||||Least squares regression|Adjusted for baseline values||Comparison of improvement in visual acuity between the 1.25mg injection at baseline and at 6 weeks treatment group and the 2.5mg injection at baseline and 6 weeks treatment group at the 3 week visit|
1750865|NCT00336323|3216759|Superiority or Other|||||||0.9|||||||Least squares regression|Adjusted for baseline values||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 12 week visit|
1750866|NCT00336323|3216759|Superiority or Other|||||||0.45||||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 9 week visit|
1750867|NCT00336323|3216759|Superiority or Other|||||||0.49||||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 6 week visit|
1750868|NCT00336323|3216759|Superiority or Other|||||||0.66||||||Adjusted for baseline values|Least squares regression|||Comparison of the reduction in central subfield thickening in the 1.25mg injection at baseline and at 6 weeks treatment group with the 2.5mg injection at baseline and 6 weeks treatment group at the 3 week visit|
1750869|NCT00336323|3216759|Superiority or Other||||||<|0.001|||||||Least squares regression|Adjusted for baseline values||Comparison of central subfield thickness at the 3 week visit between the laser only treatment group to the 2.5mg injection at baseline and 6 weeks treatment group|
1750871|NCT00336284|3216761|Superiority or Other|||||||0.016|||||||t-test, 2 sided||||
1751346|NCT00327717|3217924|Superiority or Other|||||||0.253|||||||ANOVA||||
1750872|NCT00336284|3216762|Non-Inferiority or Equivalence|Sample size of the study is based on the safety endpoint and based on a Blackwelder type test of non inferiority with the standard design criteria: Type I error (one-sided), statistical power of 80%, and 2:1 randomization. The evaluation of the primary safety endpoint was based on an exact binomial non-inferiority test comparing the proportions of patient deaths, strokes or surgical interventions.||||||0.005|||||||Exact binomial test for non-inferiority|1-sided|||
1750873|NCT00336284|3216763|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750874|NCT00336024|3216766|Superiority|||||||0.17|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.|
1750875|NCT00336024|3216766|Superiority|||||||0.26|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.|
1750876|NCT00336024|3216766|Superiority|||||||0.3|||||||Chi-squared|||Rates of nutritional toxicities in Consolidation Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.|
1750877|NCT00336024|3216766|Superiority|||||||0.17|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase III. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.|
1750878|NCT00336024|3216766|Superiority|||||||0.9|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase II. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.|
1750879|NCT00336024|3216766|Superiority|||||||0.08|||||||Chi-squared|||Rates of nutritional toxicities in Induction Phase I. The difference in number of patients with/without nutritional toxicities between the two treatment regimens will be compared using a Chi-square test.|
1750880|NCT00336024|3216767|Superiority|||||||0.7|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.|
1750881|NCT00336024|3216767|Superiority|||||||0.38|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase 2. The difference in the number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.|
1750882|NCT00336024|3216767|Superiority|||||||0.4|||||||Chi-squared|||Rates of gastrointestinal toxicities in Consolidation Phase 1. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.|
1750883|NCT00336024|3216767|Superiority|||||||0.2|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase III. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.|
1750884|NCT00336024|3216767|Superiority|||||||0.07|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase II. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.|
1750885|NCT00336024|3216767|Superiority|||||||0.27|||||||Chi-squared|||Rates of gastrointestinal toxicities in Induction Phase I. The difference in number of patients with/without gastrointestinal toxicities between the two treatment regimens will be compared using a Chi-square test.|
1750886|NCT00336024|3216768|Superiority|||||||0.8|||||||Fisher Exact|||The rate of chronic hearing loss between two treatment regimens will be be compared using Fisher exact test.|
1750887|NCT00336024|3216774|Superiority|||||||1|||||||Fisher Exact|||The rate of acute hearing loss between two treatment regimens will be be compared using Fisher exact test.|
1750888|NCT00336024|3216775|Superiority|||||||0.74|||||||Log Rank|||Difference in incidence for the two treatment regimens will be compared using log-rank test.|
1750889|NCT00336024|3216776|Superiority|||||||1|||||||Fisher Exact|||The two groups will be compared for patterns of failure to detect a statistically significant difference using Fisher exact test.|
1750890|NCT00336024|3216777|Superiority|||||||0.2|||||||Log Rank|||The difference in incidence for the two treatment regimens will be compared using a one-sided log-rank test with a significance level 0.1.|
1750891|NCT00336024|3216779|Superiority|||||||0.35|||||||Chi-squared|||The CR rates between these two groups will be compared at a significance level of 0.1 using one-sided Chi-square test.|
1750892|NCT00335972|3216780|Superiority or Other||Mean Difference (Net)|-5.0|||<|0.001|2-Sided|97.5|-10.0|-3.0||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI)|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority|
1750893|NCT00335972|3216780|Non-Inferiority or Equivalence|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority.we needed a maximum of N= 65 per group. We assumed for opioids that the coefficient of variation (SD/mean) was about 0.4, resulting in a similar sample size (64/group) with noninferiority deltas of 20% of the observed mean|Mean Difference (Net)|-5.0|||<|0.001|2-Sided|95.0|-10.0|-5.0||noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest)|Wilcoxon (Mann-Whitney)||mean difference: Dexmedetomidine arm - Remifentanil||
1750894|NCT00335972|3216781|Superiority or Other||Mean Difference (Net)|-1.9|||<|0.001|2-Sided|97.5|-2.8|-0.9||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority test|
1750968|NCT00333866|3216958|Superiority or Other||LS mean difference|-0.5||||0.1564|2-Sided|95.0|-1.2|0.19|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751347|NCT00327717|3217925|Superiority or Other|||||||0.028|||||||ANOVA||||
1750895|NCT00335972|3216781|Non-Inferiority or Equivalence|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For VRS pain, the standard deviation (SD) was expected to be about 1.75, such that with a noninferiority delta of 1, we needed a maximum of N= 66 per group|Mean Difference (Net)|-1.9|||<|0.001|2-Sided|95.0|-2.7|-1.1||noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest).|repeated measures ANOVA model||mean difference: Dexmedetomidine arm - Remifentanil arm||
1750896|NCT00335972|3216782|Superiority or Other||Mean Difference (Net)|-9.0|||<|0.001|2-Sided|97.5|-13.0|-4.0||Bonferroni correction was used for superiority testing since superiority on either hemodynamics or pain control would be interpreted as Dex better than Remi (alpha=0.0125 = 0.025/2, 97.5% CI).|repeated measures ANOVA model||mean difference: dexmedetomidine arm - remifentanil arm|superiority test|
1750897|NCT00335972|3216782|Non-Inferiority or Equivalence|Sample size was based on being able to detect noninferiority on both analgesia (pain score and opioids) and hemodynamic responses, and superiority on at least one of them with 90% power and significance level of 0.025 for each of noninferiority and superiority. For MAP with a noninferiority delta of 7.5 mmHg and expected the SD of 12, we needed a maximum of N= 65 per group. Incorporating the two interim and one final analyses, we thus planned a maximum sample size of N=71/group (N=142 total).|Mean Difference (Net)|-9.0|||<|0.001|2-Sided|95.0|-13.0|-5.0||Noninferiority confidence intervals are 95% (alpha of 0.05/2=0.025 in direction of interest). Bonferroni correction was used for superiority testing and 97.5% CI were reported.|repeated measures ANOVA||mean difference: Dexmedetomidine arm - Remifentanil arm||
1750898|NCT00335777|3216796|Non-Inferiority or Equivalence|2 sided McNemar test||||||0.289|||||||McNemar|2 sided McNemar||Null hypothesis: there is no difference in the proportion of subjects who had pain relief when treating early, as compared to treating late.|
1750899|NCT00335556|3216832|Other||Log Rank Test Statistic|3.6216||||0.057|2-Sided|95.0|||||Log Rank|||The event-free survival distributions of patients with Stage I focal and diffuse anaplastic Wilms tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.|
1750900|NCT00335556|3216834|Other||Log Rank Test Statistic|0.8814||||0.3478|2-Sided|95.0|||||Log Rank|||The overall survival distributions of patients with Stage I-IV malignant rhabdoid tumors on AREN0321 and National Wilms Tumor Study-5 -- Treatment of Relapsed Patients, A National Wilms Tumor Study Group Phase III Study (NCT00002610) were compared using the log-rank test.|
1750901|NCT00335556|3216835|Other||Log Rank Test Statistic|5.419||||0.0199|2-Sided|95.0|||||Log Rank|||The event-free survival distributions of patients with Stage II-IV diffuse anaplastic Wilms' tumor on AREN0321 and NWTS-5 (NCT00002610) were compared using the log-rank test.|
1750902|NCT00335504|3216838|Superiority or Other|||||||0.38|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between oligofructose-enriched inulin and placebo.|
1750903|NCT00335504|3216838|Superiority or Other|||||||0.88|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between sulindac and placebo.|
1750904|NCT00335504|3216838|Superiority or Other|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in apoptosis between atorvastatin calcium and placebo.|
1750905|NCT00335504|3216839|Superiority or Other|||||||0.58|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between oligofructose-enriched inulin and placebo.|
1750906|NCT00335504|3216839|Superiority or Other|||||||1|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between sulindac and placebo.|
1750907|NCT00335504|3216839|Superiority or Other|||||||0.37|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Rank Sum p-value for comparison of % change in Ki67 between atorvastatin and placebo.|
1750908|NCT00335504|3216840|Superiority or Other|||||||0.41|||||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.|
1750909|NCT00335504|3216840|Superiority or Other|||||||0.54|||||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.|
1750910|NCT00335504|3216840|Superiority or Other|||||||0.12|||||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.|
1750911|NCT00335504|3216840|Superiority or Other|||||||0.59|||||||Sign test|||Signed Rank p-value for comparison of % change in ACF within each randomization arm.|
1750912|NCT00335504|3216840|Superiority or Other|||||||0.92||||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with oligofructose-enriched inulin compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.|
1750913|NCT00335504|3216840|Superiority or Other|||||||0.6||||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with sulindac compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.|
1750914|NCT00335504|3216840|Superiority or Other|||||||0.3||||||Adjusting for multiple comparisons yields 84% power to detect a difference of at least 25% in % change of ACF at the 0.016 level of significance and using a two-sample, 2-sided t-test.|Wilcoxon (Mann-Whitney)|||The study was designed to test the hypotheses of observing a 25% difference in % change ACF over baseline, between patients treated with atorvastatin compared to placebo. N=25 subjects per group yielded 93% power to detect this difference using a 2 sided t-test at significance level of 0.05. Non-parametric tests (eg, Wilcoxon Rank Sum) could be used if the statistical assumptions of the t-test were violated.|
1751120|NCT00333775|3217014|Superiority or Other||Hazard Ratio (HR)|0.85||||0.1105|2-Sided|95.0|0.69|1.04|||Log Rank||||
1750915|NCT00335452|3216842|Superiority or Other||Relative Risk Reduction (%)|32.6||||0.0004|2-Sided|95.0|16.2|45.8||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.||
1750916|NCT00335452|3216843|Superiority or Other|||||||0.945||||||The a priori threshold for statistical significance is ≤0.05.|Regression, Logistic|Logistic regression model including a term for Clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg).|||
1750917|NCT00335452|3216844|Superiority or Other||Relative Risk Reduction (%)|14.7||||0.0332|2-Sided|95.0|1.2|26.3||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) Log-rank test. No adjustment was made.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.||
1750918|NCT00335452|3216845|Superiority or Other|||||||0.0355||||||The a priori threshold for statistical significance is ≤0.05.|Chi-squared|Interaction chi-squared test of the Cox proportional hazards model.|||
1750919|NCT00335452|3216845|Superiority or Other||Relative Risk Reduction (%)|17.6||||0.0262|2-Sided|95.0|2.2|30.5||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.||
1750920|NCT00335452|3216845|Superiority or Other||Relative Risk Reduction (%)|-6.5||||0.4579|2-Sided|95.0|-26.0|9.9||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using a stratified Cox proportional hazards model controlling for qualifying condition.||
1750921|NCT00335452|3216846|Superiority or Other||Relative Risk Reduction (%)|3.1||||0.6047|2-Sided|95.0|-9.2|14.0||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by clopidogrel treatment regimen (300/75/75 mg or 600/150/75 mg) log-rank test.|The relative risk reduction (ASA high dose versus ASA low dose) is estimated using stratified Cox proportional hazards model controlling for Clopidogrel treatment regimen.||
1750922|NCT00335452|3216847|Superiority or Other|||||||0.012||||||The a priori threshold for statistical significance is ≤0.05.|Regression, Logistic|logistic regression model including terms for ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI).|||
1750923|NCT00335452|3216848|Superiority or Other||Relative Risk Reduction (%)|6.1||||0.3037|2-Sided|95.0|-5.8|16.6||The a priori threshold for statistical significance is ≤0.05.|Log Rank|Two-sided stratified by ASA dose level (low or high) and qualifying condition (UA/NSTEMI or STEMI) log-rank test.|The relative risk reduction (high dose treatment regimen (600/150/75 mg) versus standard treatment regimen (300/75/75 mg)) is estimated using stratified Cox proportional hazards model controlling for ASA dose level and qualifying condition.||
1750924|NCT00335283|3216851|Superiority or Other||Odds Ratio, log|5.31||||0.001|2-Sided|95.0|1.97|14.3|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.|
1750925|NCT00335283|3216851|Superiority or Other||Odds Ratio, log|5.17||||0.006|2-Sided|95.0|2.02|13.2|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.|
1750926|NCT00335283|3216852|Superiority or Other||Odds Ratio, log|4.51||||0.007|2-Sided|95.0|1.5|13.6|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.|
1750927|NCT00335283|3216852|Superiority or Other||Odds Ratio, log|2.44||||0.06|2-Sided|95.0|0.95|6.31|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.|
1750928|NCT00335283|3216853|Superiority or Other||Odds Ratio, log|1.11||||0.84|2-Sided|95.0|0.4|3.06|||Regression, Logistic|||This applies to the 16 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.|
1750929|NCT00335283|3216853|Superiority or Other||Odds Ratio, log|1.01||||0.97|2-Sided|95.0|0.38|2.7|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.|
1750930|NCT00335283|3216854|Superiority or Other||Odds Ratio, log|3.5||||0.006|2-Sided|95.0|1.41|8.67|||Regression, Logistic|||This applies to the 16 week treatment affect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.|
1750931|NCT00335283|3216854|Superiority or Other||Odds Ratio, log|3.12||||0.01|2-Sided|95.0|1.28|7.59|||Regression, Logistic|||This applies to the 8 week treatment effect. A sample size of 33 patients in treated arm was considered sufficient to detect a difference of 35% between groups, assuming a lansoprazole treatment response of 70% and a placebo response of 35% with an alpha level of .05 and 90% power. A total of 75 patienst was considered an adequate sample size to allow for a 10% dropout rate.|
1750932|NCT00335257|3216856|Non-Inferiority or Equivalence|Sample size calculations were based on a non-inferiority test of two exponential survival curves.These calculations are based on the following assumptions: 1) one-sided α 0.025; 2) power (1-β) of 0.90; 3) VTE incidence rate of 9/10.000 WY and 4) non-inferiority limit hazard ratio of 2. Furthermore, a study of this size would exclude a threefold risk of ATE.|Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.5|1.3|||||Hazard ratio was adjusted for age, BMI, duration of current use, family history of VTE|Tested null hypotheses: the VTE hazard ratio for DRSP(24d) vs. Non-DRSP is higher or equal to 2|
1750933|NCT00335153|3216859|Superiority or Other|||||||0.824|||||||t-test, 2 sided||||
1750934|NCT00335153|3216860|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750935|NCT00335153|3216861|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750936|NCT00335153|3216862|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750937|NCT00335153|3216863|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750938|NCT00335153|3216864|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750939|NCT00335153|3216865|Superiority or Other|||||||0.757|||||||t-test, 2 sided||||
1750940|NCT00335153|3216866|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750941|NCT00335153|3216867|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750942|NCT00335153|3216868|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750943|NCT00335153|3216869|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750944|NCT00335153|3216870|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750945|NCT00335153|3216871|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750946|NCT00335153|3216872|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750947|NCT00335153|3216873|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750948|NCT00335153|3216874|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750949|NCT00335153|3216875|Superiority or Other|||||||0.974|||||||t-test, 2 sided||||
1750950|NCT00335153|3216876|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750951|NCT00335153|3216877|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750952|NCT00335153|3216878|Superiority or Other|||||||0.023|||||||t-test, 2 sided||||
1750953|NCT00335153|3216879|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1750954|NCT00334802|3216908|Superiority or Other|||||||0.001||||||P-value for Dose Level 2 Responders (Complete Response + Partial Response)|t-test, 2 sided||||
1750955|NCT00334802|3216908|Superiority or Other|||||||0.169||||||P-value for Dose Level 1 Responders (Complete Response + Partial Response)|t-test, 2 sided||||
1750956|NCT00334282|3216939|Superiority or Other||Hazard Ratio (HR)|0.46||||1e-07||95.0|0.34|0.62||stratified log-rank test|Log Rank||The estimated value is the hazard ratio comparing pazopanib to placebo.||
1750957|NCT00333983|3216952|Superiority or Other|||||||0.025||||||P value was set at .025 to adjust for 2 treatment comparisons and for interim monitoring for the treatment effect.|Mixed Models Analysis|||An analysis of all robot interventions compared with intensive conventional exercise for Fugl-Meyer change were completed using linear mixed models.|
1750958|NCT00333866|3216956|Superiority or Other||LS mean difference|-11.51||||0.9471|2-Sided|95.0|-351.9|328.86|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.|
1750959|NCT00333866|3216956|Superiority or Other||LS mean difference|47.89||||0.7829|2-Sided|95.0|-293.2|389.02|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.|
1750960|NCT00333866|3216956|Superiority or Other||LS mean difference|263.77||||0.1277|2-Sided|95.0|-75.78|603.33|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using analysis of variance (ANOVA), with treatment and center in the model.|
1750961|NCT00333866|3216957|Superiority or Other||LS mean difference|-2.56||||0.2694|2-Sided|95.0|-7.09|1.98|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750962|NCT00333866|3216957|Superiority or Other||LS mean difference|-7.44||||0.0014|2-Sided|95.0|-12.0|-2.88|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750963|NCT00333866|3216957|Superiority or Other||LS mean difference|-1.44||||0.534|2-Sided|95.0|-5.97|3.09|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750964|NCT00333866|3216958|Superiority or Other||LS mean difference|-0.21||||0.5191|2-Sided|95.0|-0.87|0.44|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750965|NCT00333866|3216958|Superiority or Other||LS mean difference|-0.59||||0.0778|2-Sided|95.0|-1.25|0.07|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750966|NCT00333866|3216958|Superiority or Other||LS mean difference|0.15||||0.6416|2-Sided|95.0|-0.5|0.8|||ANCOVA|||HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750967|NCT00333866|3216958|Superiority or Other||LS mean difference|-0.11||||0.7519|2-Sided|95.0|-0.8|0.58|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750969|NCT00333866|3216958|Superiority or Other||LS mean difference|-0.59||||0.09|2-Sided|95.0|-1.28|0.09|||ANCOVA|||HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750970|NCT00333866|3216959|Superiority or Other||LS mean difference|-0.87||||0.3137|2-Sided|95.0|-2.58|0.83|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750971|NCT00333866|3216959|Superiority or Other||LS mean difference|-1.41||||0.1044|2-Sided|95.0|-3.12|0.29|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750972|NCT00333866|3216959|Superiority or Other||LS mean difference|-0.29||||0.7384|2-Sided|95.0|-1.98|1.4|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750973|NCT00333866|3216960|Superiority or Other||LS mean difference|0.13||||0.8576|2-Sided|95.0|-1.28|1.54|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750974|NCT00333866|3216960|Superiority or Other||LS mean difference|0.54||||0.4564|2-Sided|95.0|-0.88|1.96|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750975|NCT00333866|3216960|Superiority or Other||LS mean difference|-0.13||||0.8529|2-Sided|95.0|-1.54|1.27|||ANCOVA|||Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750976|NCT00333866|3216960|Superiority or Other||LS mean difference|2.14||||0.0568|2-Sided|95.0|-0.06|4.34|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750977|NCT00333866|3216960|Superiority or Other||LS mean difference|3.66||||0.0013|2-Sided|95.0|1.44|5.88|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750978|NCT00333866|3216960|Superiority or Other||LS mean difference|2.62||||0.0195|2-Sided|95.0|0.42|4.82|||ANCOVA|||Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750979|NCT00333866|3216960|Superiority or Other||LS mean difference|1.82||||0.2526|2-Sided|95.0|-1.3|4.95|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750980|NCT00333866|3216960|Superiority or Other||LS mean difference|2.73||||0.091|2-Sided|95.0|-0.44|5.89|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750981|NCT00333866|3216960|Superiority or Other||LS mean difference|1.27||||0.4253|2-Sided|95.0|-1.86|4.39|||ANCOVA|||General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750982|NCT00333866|3216960|Superiority or Other||LS mean difference|0.75||||0.7031|2-Sided|95.0|-3.1|4.6|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750983|NCT00333866|3216960|Superiority or Other||LS mean difference|5.1||||0.0101|2-Sided|95.0|1.22|8.99|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750984|NCT00333866|3216960|Superiority or Other||LS mean difference|3.15||||0.1081|2-Sided|95.0|-0.69|6.99|||ANCOVA|||Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750985|NCT00333866|3216960|Superiority or Other||LS mean difference|2.82||||0.118|2-Sided|95.0|-0.72|6.36|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750986|NCT00333866|3216960|Superiority or Other||LS mean difference|5.36||||0.0032|2-Sided|95.0|1.8|8.93|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750987|NCT00333866|3216960|Superiority or Other||LS mean difference|2.58||||0.1524|2-Sided|95.0|-0.95|6.11|||ANCOVA|||Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750988|NCT00333866|3216960|Superiority or Other||LS mean difference|3.32||||0.0763|2-Sided|95.0|-0.35|6.99|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750989|NCT00333866|3216960|Superiority or Other||LS mean difference|5.93||||0.0017|2-Sided|95.0|2.23|9.62|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750990|NCT00333866|3216960|Superiority or Other||LS mean difference|4.08||||0.0291|2-Sided|95.0|0.42|7.74|||ANCOVA|||Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750991|NCT00333866|3216960|Superiority or Other||LS mean difference|3.35||||0.1721|2-Sided|95.0|-1.46|8.16|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750992|NCT00333866|3216960|Superiority or Other||LS mean difference|5.01||||0.0429|2-Sided|95.0|0.16|9.85|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750993|NCT00333866|3216960|Superiority or Other||LS mean difference|2.85||||0.2446|2-Sided|95.0|-1.95|7.65|||ANCOVA|||Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750994|NCT00333866|3216960|Superiority or Other||LS mean difference|3.75||||0.162|2-Sided|95.0|-1.51|9.02|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750995|NCT00333866|3216960|Superiority or Other||LS mean difference|6.24||||0.0213|2-Sided|95.0|0.93|11.54|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750996|NCT00333866|3216960|Superiority or Other||LS mean difference|3.87||||0.1489|2-Sided|95.0|-1.39|9.12|||ANCOVA|||Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750997|NCT00333866|3216960|Superiority or Other||LS mean difference|0.39||||0.8625|2-Sided|95.0|-4.04|4.82|||ANCOVA|||Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750998|NCT00333866|3216960|Superiority or Other||LS mean difference|1.5||||0.5105|2-Sided|95.0|-2.96|5.96|||ANCOVA|||Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1750999|NCT00333866|3216960|Superiority or Other||LS mean difference|1.02||||0.649|2-Sided|95.0|-3.39|5.43|||ANCOVA|||Physical role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751000|NCT00333866|3216960|Superiority or Other||LS mean difference|0.58||||0.7512|2-Sided|95.0|-3.0|4.15|||ANCOVA|||Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751001|NCT00333866|3216960|Superiority or Other||LS mean difference|1.99||||0.2792|2-Sided|95.0|-1.62|5.59|||ANCOVA|||Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751002|NCT00333866|3216960|Superiority or Other||LS mean difference|-0.51||||0.7781|2-Sided|95.0|-4.07|3.05|||ANCOVA|||Physical functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751003|NCT00333866|3216961|Superiority or Other||LS mean difference|-1.17||||0.5126|2-Sided|95.0|-4.68|2.34|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751004|NCT00333866|3216961|Superiority or Other||LS mean difference|-5.85||||0.0012|2-Sided|95.0|-9.38|-2.31|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751005|NCT00333866|3216961|Superiority or Other||LS mean difference|-1.44||||0.42|2-Sided|95.0|-4.95|2.06|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751006|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.33||||0.229|2-Sided|95.0|-0.88|0.21|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751007|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.97||||0.0006|2-Sided|95.0|-1.51|-0.42|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751008|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.2||||0.4617|2-Sided|95.0|-0.75|0.34|||ANCOVA|||FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751009|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.18||||0.5101|2-Sided|95.0|-0.71|0.35|||ANCOVA|||FIQ anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751010|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.64||||0.0192|2-Sided|95.0|-1.18|-0.1|||ANCOVA|||FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751011|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.19||||0.4743|2-Sided|95.0|-0.73|0.34|||ANCOVA|||FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751012|NCT00333866|3216962|Superiority or Other||LS mean difference|0.03||||0.8936|2-Sided|95.0|-0.45|0.52|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751013|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.22||||0.374|2-Sided|95.0|-0.71|0.27|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751014|NCT00333866|3216962|Superiority or Other||LS mean difference|0.12||||0.6326|2-Sided|95.0|-0.37|0.6|||ANCOVA|||FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751015|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.23||||0.3845|2-Sided|95.0|-0.75|0.29|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751016|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.53||||0.047|2-Sided|95.0|-1.06|-0.01|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751017|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.46||||0.0806|2-Sided|95.0|-0.98|0.06|||ANCOVA|||FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751018|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.05||||0.8432|2-Sided|95.0|-0.54|0.44|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751019|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.56||||0.027|2-Sided|95.0|-1.05|-0.06|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751020|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.24||||0.3294|2-Sided|95.0|-0.73|0.25|||ANCOVA|||FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751021|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.21||||0.3692|2-Sided|95.0|-0.68|0.25|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751022|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.75||||0.0016|2-Sided|95.0|-1.22|-0.28|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751023|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.14||||0.5609|2-Sided|95.0|-0.6|0.33|||ANCOVA|||FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751024|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.14||||0.5613||95.0|-0.63|0.34|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751025|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.71||||0.0045|2-Sided|95.0|-1.19|-0.22|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751026|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.09||||0.7236|2-Sided|95.0|-0.57|0.4|||ANCOVA|||FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751027|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.16||||0.5408|2-Sided|95.0|-0.66|0.35|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751028|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.61||||0.0174|2-Sided|95.0|-1.12|-0.11|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751029|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.14||||0.5923|2-Sided|95.0|-0.64|0.37|||ANCOVA|||FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751030|NCT00333866|3216962|Superiority or Other||LS mean difference|0.04||||0.9077|2-Sided|95.0|-0.56|0.63|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751031|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.63||||0.0409|2-Sided|95.0|-1.23|-0.03|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751032|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.11||||0.7147|2-Sided|95.0|-0.71|0.49|||ANCOVA|||FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751033|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.18||||0.3468|2-Sided|95.0|-0.55|0.19|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751034|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.26||||0.1686|2-Sided|95.0|-0.63|0.11|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751035|NCT00333866|3216962|Superiority or Other||LS mean difference|-0.17||||0.3627|2-Sided|95.0|-0.54|0.2|||ANCOVA|||FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751036|NCT00333866|3216963|Superiority or Other||LS mean difference|-4.36||||0.0197|2-Sided|95.0|-8.02|-0.7|||ANCOVA|||Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751037|NCT00333866|3216963|Superiority or Other||LS mean difference|-8.25|||<|0.0001|2-Sided|95.0|-11.94|-4.55|||ANCOVA|||Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751121|NCT00333775|3217017|Superiority or Other||Hazard Ratio, log|0.72||||0.0036|2-Sided|95.0|0.57|0.9|||Log Rank||||
1751038|NCT00333866|3216963|Superiority or Other||LS mean difference|-6.9|||<|0.0002|2-Sided|95.0|-10.54|-3.25|||ANCOVA|||Overall sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751039|NCT00333866|3216963|Superiority or Other||LS mean difference|0.76|||<|0.7132|2-Sided|95.0|-3.31|4.84|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751040|NCT00333866|3216963|Superiority or Other||LS mean difference|0.7|||<|0.7364|2-Sided|95.0|-3.39|4.8|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751041|NCT00333866|3216963|Superiority or Other||LS mean difference|2.01|||<|0.3308|2-Sided|95.0|-2.05|6.07|||ANCOVA|||Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751042|NCT00333866|3216963|Superiority or Other||LS mean difference|2.56|||<|0.337|2-Sided|95.0|-2.68|7.81|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751043|NCT00333866|3216963|Superiority or Other||LS mean difference|9.14|||<|0.0007|2-Sided|95.0|3.88|14.41|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751044|NCT00333866|3216963|Superiority or Other||LS mean difference|4.34|||<|0.1033|2-Sided|95.0|-0.88|9.57|||ANCOVA|||Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751045|NCT00333866|3216963|Superiority or Other||LS mean difference|0.21|||<|0.1453|2-Sided|95.0|-0.07|0.49|||ANCOVA|||Quality of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751046|NCT00333866|3216963|Superiority or Other||LS mean difference|0.5|||<|0.0005|2-Sided|95.0|0.22|0.79|||ANCOVA|||Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751047|NCT00333866|3216963|Superiority or Other||LS mean difference|0.36|||<|0.0127|2-Sided|95.0|0.08|0.64|||ANCOVA|||Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751048|NCT00333866|3216963|Superiority or Other||LS mean difference|-8.95|||<|0.0008|2-Sided|95.0|-14.16|-3.74|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751049|NCT00333866|3216963|Superiority or Other||LS mean difference|-11.92|||<|0.0001||95.0|-17.17|-6.68|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751050|NCT00333866|3216963|Superiority or Other||LS mean difference|-9.24|||<|0.0005|2-Sided|95.0|-14.44|-4.05|||ANCOVA|||Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751051|NCT00333866|3216963|Superiority or Other||LS mean difference|1.21|||<|0.6165|2-Sided|95.0|-3.53|5.95|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751052|NCT00333866|3216963|Superiority or Other||LS mean difference|4.92|||<|0.0414|2-Sided|95.0|0.19|9.66|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751053|NCT00333866|3216963|Superiority or Other||LS mean difference|5.9|||<|0.0142|2-Sided|95.0|1.19|10.61|||ANCOVA|||Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751054|NCT00333866|3216963|Superiority or Other||LS mean difference|-7.2|||<|0.0038|2-Sided|95.0|-12.06|-2.33|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751055|NCT00333866|3216963|Superiority or Other||LS mean difference|-13.28|||<|0.0001|2-Sided|95.0|-18.18|-8.38|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751056|NCT00333866|3216963|Superiority or Other||LS mean difference|-12.71|||<|0.0001|2-Sided|95.0|-17.56|-7.86|||ANCOVA|||Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.|
1751057|NCT00333866|3216964|Superiority or Other||Odds Ratio (OR)|1.01||||0.9613|2-Sided|95.0|0.61|1.68|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.|
1751058|NCT00333866|3216964|Superiority or Other||Odds Ratio (OR)|1.92||||0.0109|2-Sided|95.0|1.16|3.18|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.|
1751059|NCT00333866|3216964|Superiority or Other||Odds Ratio (OR)|1.17||||0.537|2-Sided|95.0|0.71|1.95|||Regression, Logistic|||P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.|
1751122|NCT00333775|3217017|Superiority or Other||Hazard Ratio (HR)|0.79||||0.0318|2-Sided|95.0|0.63|0.98|||Log Rank||||
1751123|NCT00333619|3217020|Superiority or Other|||||||0.12|||||||ANOVA||||
1751124|NCT00333619|3217021|Superiority or Other|||||||0.1|||||||ANOVA||||
1751060|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.66|||<|0.0001|2-Sided|95.0|-1.0|-0.4|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751061|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.86|||<|0.0001|2-Sided|95.0|-1.1|-0.6|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751062|NCT00333866|3216965|Superiority or Other||LS mean difference|-1.16|||<|0.0001|2-Sided|95.0|-1.5|-0.9|||Mixed Model Repeated Measures ANCOVA|||Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751063|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.65|||<|0.0036|2-Sided|95.0|-1.1|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751064|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.87|||<|0.0001|2-Sided|95.0|-1.3|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751065|NCT00333866|3216965|Superiority or Other||LS mean difference|-1.21|||<|0.0001|2-Sided|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751066|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.61|||<|0.0054|2-Sided|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751067|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.88|||<|0.0001|2-Sided|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751068|NCT00333866|3216965|Superiority or Other||LS mean difference|-1.21|||<|0.0001|2-Sided|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751069|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.4|||<|0.069|2-Sided|95.0|-0.8|0.0|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751070|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.73|||<|0.0006|2-Sided|95.0|-1.2|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751071|NCT00333866|3216965|Superiority or Other||LS mean difference|-1.07|||<|0.0001|2-Sided|95.0|-1.5|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751072|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.56|||<|0.01|2-Sided|95.0|-1.0|-0.1|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751073|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.83|||<|0.0001|2-Sided|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751074|NCT00333866|3216965|Superiority or Other||LS mean difference|-1.15|||<|0.0001|2-Sided|95.0|-1.6|-0.7|||Mixed Model Repeated Measures ANCOVA|||Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751075|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.61|||<|0.004|2-Sided|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751076|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.9|||<|0.0001|2-Sided|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751077|NCT00333866|3216965|Superiority or Other||LS mean difference|-1.2|||<|0.0001|2-Sided|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751125|NCT00333437|3217024|Superiority or Other||Mean Difference (Net)|1.8643|Standard Deviation|1.5013||0.0167|2-Sided|95.0|0.4758|3.2527||significant p<0.05|t-test, 2 sided|||H(0): Post-pre DLCO = 0|
1751078|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.53|||<|0.0117|2-Sided|95.0|-0.9|-0.1|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751079|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.83|||<|0.0001|2-Sided|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751080|NCT00333866|3216965|Superiority or Other||LS mean difference|-1.12|||<|0.0001|2-Sided|95.0|-1.5|-0.7|||Mixed Model Repeated Measures ANCOVA|||Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751081|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.61|||<|0.0031|2-Sided|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751082|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.97|||<|0.0001|2-Sided|95.0|-1.4|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751083|NCT00333866|3216965|Superiority or Other||LS mean difference|-1.27|||<|0.0001|2-Sided|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751084|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.59|||<|0.0037|2-Sided|95.0|-1.0|-0.2|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751085|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.92|||<|0.0001|2-Sided|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751086|NCT00333866|3216965|Superiority or Other||LS mean difference|-1.29|||<|0.0001|2-Sided|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751087|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.72|||<|0.0003|2-Sided|95.0|-1.1|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751088|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.92|||<|0.0001|2-Sided|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751089|NCT00333866|3216965|Superiority or Other||LS mean difference|-1.31|||<|0.0001|2-Sided|95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751090|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.85|||<|0.0001|2-Sided|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751091|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.87|||<|0.0001|2-Sided|95.0|-1.3|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751092|NCT00333866|3216965|Superiority or Other||LS mean difference|-1.17|||<|0.0001|2-Sided|95.0|-1.6|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751093|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.8|||<|0.0001|2-Sided|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751094|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.94|||<|0.0001|2-Sided|95.0|-1.3|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751095|NCT00333866|3216965|Superiority or Other||LS mean difference|-1.28|||<|0.0001||95.0|-1.7|-0.9|||Mixed Model Repeated Measures ANCOVA|||Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751126|NCT00333437|3217025|Superiority or Other||Mean Difference (Final Values)|264.26|Standard Deviation|194.66||0.0115|2-Sided|95.0|84.256|444.32||Significant p<0.05|t-test, 2 sided|Not adjusted||H(0): post-pre walk distance = 0|
1751096|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.67|||<|0.0005|2-Sided|95.0|-1.0|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751097|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.8|||<|0.0001|2-Sided|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751098|NCT00333866|3216965|Superiority or Other||LS mean difference|-1.15|||<|0.0001|2-Sided|95.0|-1.5|-0.8|||Mixed Model Repeated Measures ANCOVA|||Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751099|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.86|||<|0.0001|2-Sided|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751100|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.81|||<|0.0001|2-Sided|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751101|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.97|||<|0.0001|2-Sided|95.0|-1.3|-0.6|||Mixed Model Repeated Measures ANCOVA|||Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751102|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.81|||<|0.0001|2-Sided|95.0|-1.2|-0.4|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751103|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.7|||<|0.0003|2-Sided|95.0|-1.1|-0.3|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751104|NCT00333866|3216965|Superiority or Other||LS mean difference|-0.85|||<|0.0001|2-Sided|95.0|-1.2|-0.5|||Mixed Model Repeated Measures ANCOVA|||Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.|
1751105|NCT00333866|3216966|Superiority or Other||LS mean difference|-0.48||||0.0222|2-Sided|95.0|-0.89|-0.07|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.|
1751106|NCT00333866|3216966|Superiority or Other||LS mean difference|-0.78||||0.0002|2-Sided|95.0|-1.2|-0.37|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.|
1751107|NCT00333866|3216966|Superiority or Other||LS mean difference|-1.01|||<|0.0001|2-Sided|95.0|-1.42|-0.6|||ANCOVA|||P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.|
1751108|NCT00333866|3216967|Superiority or Other|||||||0.0768|||||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.|
1751109|NCT00333866|3216967|Superiority or Other|||||||0.0017|||||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.|
1751110|NCT00333866|3216967|Superiority or Other|||||||0.0227|||||||Cochran-Mantel-Haenszel|||P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.|
1751111|NCT00333866|3216968|Superiority or Other||Least Squares (LS) mean difference|-0.33||||0.1694|2-Sided|95.0|-0.72|0.05|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.|
1751112|NCT00333866|3216968|Superiority or Other||LS mean difference|-0.56||||0.0132|2-Sided|95.0|-0.94|-0.17|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.|
1751113|NCT00333866|3216968|Superiority or Other||Least Squares (LS) mean difference|-0.23||||0.2361|2-Sided|95.0|-0.61|0.15|||ANCOVA|Hochberg's approach was used to protect the Type I error rate at 0.05 level, Hochberg adjusted p-values were presented.||P value was calculated using Analysis of Covariance (ANCOVA) with treatment and center in the model, and the baseline mean pain score as covariate.|
1751114|NCT00333801|3216986|Superiority or Other||Cohen's d|0.93|||<|0.001|2-Sided||||||Wilcoxon (Mann-Whitney)||||
1751115|NCT00333801|3216987|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)||||
1751116|NCT00333801|3216988|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1751117|NCT00333775|3217013|Superiority or Other||Hazard Ratio (HR)|0.68||||0.0765|2-Sided|95.0|0.45|1.04|||Log Rank||||
1751118|NCT00333775|3217013|Superiority or Other||Hazard Ratio (HR)|0.92||||0.6962|2-Sided|95.0|0.62|1.37|||Log Rank||||
1751119|NCT00333775|3217014|Superiority or Other||Hazard Ratio (HR)|0.79||||0.0241|2-Sided|95.0|0.65|0.97|||Log Rank||||
1751127|NCT00333437|3217027|Superiority or Other||Mean Difference (Final Values)|-6.286|Standard Deviation|16.358||0.3485|2-Sided|95.0|-21.41|8.8426||significant p<0.05|t-test, 2 sided|||H(0): post-pre eosinophil count = 0|
1751128|NCT00333437|3217027|Superiority or Other||Mean Difference (Final Values)|-3.0|Standard Deviation|8.1035||0.3652|2-Sided|95.0|-10.49|4.4945||significant p<0.05|t-test, 2 sided|||H(0): Post-pre neutrophil count = 0|
1751129|NCT00333437|3217028|Superiority or Other||Change from Baseline|0.1786|Standard Deviation|0.1613||0.026|2-Sided|95.0|0.0294|0.3277||Not adjusted|t-test, 2 sided|||H(0): post-pre FVC (liters) = 0|
1751130|NCT00333177|3217047|Superiority||||||=|0||||||2 X 2 ANOVA computed. P-value is for RLAI vs. Oral Ris main effect.|ANOVA||||
1751131|NCT00333177|3217048|Superiority||||||<|0.02||||||2 X 2 ANOVA computed. P-value is for main effect of CT vs. HBT.|ANOVA||||
1751132|NCT00333177|3217049|Superiority||||||<|0.05||||||2 X 2 ANOVA calculated. P-value is for main effect of RLAI vs. Oral Ris.|ANOVA||||
1751133|NCT00333177|3217050|Superiority||||||<|0.01|||||||Chi-squared|df = 1||Chi-square of frequencies of relapse vs. non-relapse were calculated, with a priori hypothesis that RLAI would be superior to Oral Ris.|
1751134|NCT00333177|3217051|Superiority||||||<|0.02||||||A priori hypotheses were that CT would be superior to HBT and that RLAI would be superior to Oral Ris.|ANOVA|2 X 2 ANOVA was computed.|||
1751135|NCT00333177|3217052|Superiority|||||||0.55|||||||ANOVA||||
1751136|NCT00333177|3217053|Superiority||||||<|0.05||||||P-value is for CT vs. HBT main effect.|ANCOVA|Baseline value of dependent variable was covaried.||2 X 2 ANOVA was calculated. A priori hypotheses were that CT would be superior to HBT and that RLAI would be superior to Oral Ris.|
1751137|NCT00333177|3217054|Superiority||Mean Difference (Final Values)|0.84||||0.001|2-Sided|95.0|0.57|1.1|||t-test, 2 sided|||A priori hypothesis was that RLAI would lead to less medication non-adherence than Oral Ris.|
1751138|NCT00333177|3217055|Superiority||||||<|0.02||||||P-value is for each main effect. A priori threshold for statistical significance was p<0.05 for each main effect.|ANCOVA|Baseline value of dependent variable was covaried.||2 X 2 ANOVA was calculated. A priori hypotheses were that LAI would be superior to oral risperidone and that CT would be superior to health behavior training (HBT) based on main effects.|
1751139|NCT00333177|3217056|Superiority||||||<|0.03||||||P value is for CT-HBT X RLAI-Oral Ris interaction|ANCOVA|Covaried baseline value of dependent variable||A priori hypothesis was that CT would be superior to HBT and that RLAI would enhance this effect.|
1751140|NCT00332722|3217075|Superiority or Other||||||<|0.05|||||||Paired t test||||
1751141|NCT00332722|3217076|Superiority or Other||||||<|0.05|||||||Paired t test||||
1751142|NCT00332488|3217101|Superiority or Other||Mean Difference (Final Values)|0.91|||<|0.001|2-Sided|95.0|0.69|1.14|||ANCOVA|Type III||ANCOVA fitting model change from baseline in A1c with fixed effects for treatment and pooled site and baseline A1c as a covariate|
1751143|NCT00332488|3217102|Superiority or Other||Mean Difference (Final Values)|0.08||||0.42|2-Sided|95.0|-0.11|0.27|||ANCOVA|||ANCOVA fitting model change from baseline in A1c with fixed effects for treatment and pooled site and baseline A1c as a covariate|
1751144|NCT00332332|3217108|Superiority or Other||Percentage of participants|73.5||||||95.0|67.2|79.1|||||||
1751145|NCT00332202|3217118|Superiority||Hazard Ratio (HR)|1.286||||0.585|2-Sided|95.0|0.527|3.137|||Regression, Cox||||
1751146|NCT00332202|3217118|Superiority or Other||Hazard Ratio (HR)|1.775||||0.084|2-Sided|95.0|0.947|3.329|||Regression, Cox||||
1751147|NCT00332202|3217119|Superiority||Hazard Ratio (HR)|1.309||||0.539|2-Sided|95.0|0.557|3.08|||Regression, Cox||||
1751148|NCT00332202|3217119|Superiority||Hazard Ratio (HR)|0.768||||0.4|2-Sided|95.0|0.415|1.42|||Regression, Cox||||
1751149|NCT00332202|3217120|Superiority or Other|||||||0.864|||||||Mixed Models Analysis|||Analysis for Month 33|
1751150|NCT00332202|3217120|Superiority or Other|||||||0.807|||||||Mixed Models Analysis|||Analysis for Month 24|
1751151|NCT00332202|3217120|Superiority or Other|||||||0.267|||||||Mixed Models Analysis|||Analysis for Month 6|
1751152|NCT00332202|3217121|Superiority or Other|||||||0.357|||||||Mixed Models Analysis|||Analysis for Month 36|
1751153|NCT00332202|3217121|Superiority or Other|||||||0.441|||||||Mixed Models Analysis|||Analysis for Month 24|
1751154|NCT00332202|3217121|Superiority or Other|||||||0.46|||||||Mixed Models Analysis|||Analysis for Month 18|
1751155|NCT00332202|3217121|Superiority or Other|||||||0.265|||||||Mixed Models Analysis|||Analysis for Month 12|
1751156|NCT00332202|3217121|Superiority or Other|||||||0.58|||||||Mixed Models Analysis|||Analysis for Month 6|
1751157|NCT00332202|3217121|Superiority or Other|||||||0.971|||||||Mixed Models Analysis|||Analysis for Month 4|
1751158|NCT00332202|3217121|Superiority or Other|||||||0.606|||||||Mixed Models Analysis|||Analysis for Month 2|
1751159|NCT00332202|3217127|Superiority or Other||Hazard Ratio (HR)|0.92||||0.541|2-Sided|95.0|0.689|1.216|||Log Rank||||
1751160|NCT00332163|3217131|Superiority or Other||Hazard Ratio (HR)|1.0|||||2-Sided|95.0|0.6|1.6|||||Hazard ratio is estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).||
1751161|NCT00332163|3217132|Superiority or Other||Hazard Ratio (HR)|1.2|||||2-Sided|95.0|0.7|2.1|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).||
1751162|NCT00332163|3217133|Superiority or Other||Hazard Ratio (HR)|0.9|||||2-Sided|95.0|0.6|1.5|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).||
1751163|NCT00332163|3217134|Superiority or Other||Hazard Ratio (HR)|1.3|||||2-Sided|95.0|0.9|2.0|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).||
1751164|NCT00332163|3217135|Superiority or Other||Difference|-1.0|||||2-Sided|95.0|-21.0|18.0|||||Rate difference = Pre-emptive – Reactive||
1751165|NCT00332163|3217136|Superiority or Other||Difference|4.0|||||2-Sided|95.0|-9.0|17.0|||||Rate difference = Pre-emptive - Reactive||
1751168|NCT00332163|3217139|Superiority or Other||Hazard Ratio (HR)|0.4|||||2-Sided|95.0|0.2|0.7|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (Pre-emptive vs. Reactive) stratified by chemotherapy stratum (Q2W vs Q3W).||
1751169|NCT00332163|3217141|Superiority or Other||Hazard Ratio (HR)|0.4|||||2-Sided|95.0|0.2|0.7|||||Hazard ratio estimated from a Cox Proportional Hazards regression model with an indicator for treatment (pre-emptive vs. reactive), stratified by chemotherapy stratum (Q2W vs Q3W).||
1751170|NCT00332163|3217142|Superiority or Other||Difference|-22.0|||||2-Sided|95.0|-42.0|-3.0|||||Difference = Pre-emptive - Reactive||
1751171|NCT00332163|3217143|Superiority or Other||Difference|-33.0|||||2-Sided|95.0|-51.0|-14.0|||||Difference = Pre-emptive - Reactive||
1751172|NCT00331799|3217152|Superiority or Other|||||||0.00365|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon Signed Rank test on the difference between the baseline and endpoint score on the CD-RISC.|
1751173|NCT00331773|3217156|Superiority or Other (legacy)|||||||0.56||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||60-month index score|
1751174|NCT00331773|3217156|Superiority or Other (legacy)|||||||0.39||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||60-month VAS score|
1751175|NCT00331773|3217156|Superiority or Other (legacy)|||||||0.45||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||24-month index score|
1751176|NCT00331773|3217156|Superiority or Other (legacy)|||||||0.86||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||24-month VAS score|
1751177|NCT00331773|3217156|Superiority or Other (legacy)|||||||0.19||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||12-month index score|
1751178|NCT00331773|3217156|Superiority or Other (legacy)|||||||0.31||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||12-month VAS score|
1751179|NCT00331773|3217156|Superiority or Other (legacy)|||||||0.2||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||6-month index score|
1751180|NCT00331773|3217156|Superiority or Other (legacy)|||||||0.7||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||6-month VAS score|
1751181|NCT00331773|3217156|Superiority or Other (legacy)|||||||0.12||||||Two-sided significance level = 0.05|Wilcoxon (Mann-Whitney)|||Baseline index score|
1751182|NCT00331773|3217156|Superiority or Other (legacy)|||||||0.037|||||||Wilcoxon (Mann-Whitney)|Two-sided significance level = 0.05||Baseline VAS score|
1751183|NCT00331773|3217157|Superiority or Other (legacy)|||||||0.028|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 60 months (5 years) was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.|
1751184|NCT00331773|3217157|Superiority or Other (legacy)|||||||0.23|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 24 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.|
1751185|NCT00331773|3217157|Superiority or Other (legacy)|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 12 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.|
1751186|NCT00331773|3217157|Superiority or Other (legacy)|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||The distribution of HSCL-25 at 6 months was calculated, and Wilcoxon test statistics were used to test the null hypothesis that responses are the same across the two treatment arms versus the alternative hypothesis that they are different. Significance level = 0.0125, two-sided test.|
1751187|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 60 months|
1751188|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 60 months|
1751189|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 60 months|
1751190|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.071|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 60 months|
1751191|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.68|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 24 months|
1751192|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 24 months|
1751193|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.81|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 24 months|
1751194|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.12|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 24 months|
1751195|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 12 months|
1751196|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.94|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 12 months|
1751197|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.062|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 12 months|
1751198|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.0037|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 12 months|
1751199|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.49|||||||Wilcoxon (Mann-Whitney)|||EPIC Hormonal Domain at 6 months|
1751200|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||EPIC Sexual Domain at 6 months|
1751201|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.056|||||||Wilcoxon (Mann-Whitney)|||EPIC Urinary Domain at 6 months|
1751202|NCT00331773|3217159|Superiority or Other (legacy)|||||||0.72|||||||Wilcoxon (Mann-Whitney)|||EPIC Bowel Domain at 6 months|
1751203|NCT00331773|3217160|Superiority or Other (legacy)||Risk Ratio (RR)|1.56||||0.22|2-Sided|95.0|0.76|3.18||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GU toxicity rates were tabulated and dichotomized as < grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.|
1751222|NCT00330733|3217258|Superiority or Other (legacy)||||||<|0.05|||||||t-test, 2 sided|||Paired comparisons (follow-up vs baseline) and unpaired group comparisons were performed by Student’s t tests or Wilcoxon signed rank tests.|
1751204|NCT00331773|3217160|Superiority or Other (legacy)||Risk Ratio (RR)|1.31||||0.009|2-Sided|95.0|1.07|1.61||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GU toxicity rates were tabulated and dichotomized as < grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.|
1751205|NCT00331773|3217160|Superiority or Other (legacy)||Risk Ratio (RR)|1.55||||0.19|2-Sided|95.0|0.8|2.99||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GI toxicity rates were tabulated and dichotomized as < grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.|
1751206|NCT00331773|3217160|Superiority or Other (legacy)||Risk Ratio (RR)|1.59||||0.005|2-Sided|95.0|1.22|2.06||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Late GI toxicity rates were tabulated and dichotomized as < grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.|
1751207|NCT00331773|3217160|Superiority or Other (legacy)||Risk Ratio (RR)|1.36||||0.39|2-Sided|95.0|0.67|2.74||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GU toxicity rates were tabulated and dichotomized as < grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.|
1751208|NCT00331773|3217160|Superiority or Other (legacy)||Odds Ratio (OR)|0.99||||0.95|2-Sided|95.0|0.82|1.21||2-sided|Regression, Logistic||Reference Arm = Conventional 3D-CRT|Acute GU toxicity rates were tabulated and dichotomized as < grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.|
1751209|NCT00331773|3217160|Superiority or Other (legacy)||Risk Ratio (RR)|1.31||||0.72|2-Sided|95.0|0.29|5.81||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GI toxicity rates were tabulated and dichotomized as < grade 3 vs ≥ grade 3. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% CIs were computed.|
1751210|NCT00331773|3217160|Superiority or Other (legacy)||Risk Ratio (RR)|1.03||||0.85|2-Sided|95.0|0.73|1.46||2-sided|Regression, Logistic||Reference arm = Conventional 3D-CRT|Acute GI toxicity rates were tabulated and dichotomized as < grade 2 vs ≥ grade 2. To evaluate the differences by treatment arm, 2 X 2 subtables were formed and relative risk (RR) estimates with 95% confidence intervals (CIs) were computed.|
1751211|NCT00331773|3217161|Non-Inferiority or Equivalence (legacy)|Non-inferiority was assessed against a HR of 1.54, translated from a 5% difference in overall survival with 90% overall survival in the Conventional 3D-CRT arm. The log-rank test was used with a two-sided p-value of 0.05.|Hazard Ratio (HR)|0.95||||0.008|2-Sided|95.0|0.64|1.41|||Log Rank||Reference arm = Conventional 3D-CRT||
1751212|NCT00331773|3217162|Non-Inferiority or Equivalence (legacy)|Patients who died without biochemical failure were considered as competing risk at the time of death. Patients alive without biochemical failure at last follow-up were censored at that date. Estimates were calculated using cumulative risk and non-inferiority was assessed against a HR of 1.67. The log-rank test was used with a two-sided p-value of 0.05.|Hazard Ratio (HR)|0.77|||<|0.001|2-Sided|95.0|0.51|1.17|||Log Rank||Reference arm = Conventional 3D-CRT||
1751213|NCT00331773|3217165|Non-Inferiority or Equivalence (legacy)|This trial was designed to establish with 90% power and a two-sided significance level of 0.05 that Arm 2 (Hypofractionated 3D-CRT) results in a 5-year DFS that is not lower than Arm 1 by more than 7.65% (hazard ratio [HR] , 1.52). Patients analyzed according to assignment, with time-to event duration originating at random assignment. DFS distributions calculated using the Kaplan-Meier method. Treatment efficacy for DFS was tested by comparing cause-specific hazards with the log-rank statistic.|Hazard Ratio (HR)|0.85|||<|0.001|2-Sided|95.0|0.64|1.14|||Log Rank||Reference arm = Conventional 3D-CRT||
1751214|NCT00331760|3217173|Superiority|||||||0.043|||||||Chi-squared|||A sample size of 42 patients provides 88% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 20%.|
1751215|NCT00331760|3217173|Superiority|||||||0.12|||||||Chi-squared|||A sample size of 42 patients provides 64% power to detect a reduction in short-term grade 2 or higher bowel AEs from historical rate of 40% to 25%.|
1751216|NCT00331344|3217206|Other||Dose Level VIa|1.0|||||2-Sided||||||||Dose level VIa (mitoxantrone hydrochloride 12 mg/m2 IV over 30 minutes, ixabepilone 30mg/m2 IV over 3 hours on day 1, pegfilgrastim 6mg SC on day 2, oral prednisone twice daily on days 1-21) was determined to be MTD, based on 1 event of DLT at VIa.|Cohorts of 3 patients will be enrolled at each dose level; if 1 dose limiting toxicity (DLT) is observed then the cohort will be expanded to 6 patients. If a second DLT is observed, the previous dose level will be considered the MTD. If all observed DLT are due to neuropathy (specific to ixabepilone), then we would consider the previous dose level of Ixabepilone the MTD for that drug, and escalate mitoxantrone hydrochloride as described above to a maximum dose of 12 mg/m^2.|
1751217|NCT00331006|3217223|Superiority or Other||Proportion|0.25|||||2-Sided|95.0|0.073|0.524||||||No hypothesis about the value of this proportion was specified in the study design|
1751218|NCT00331006|3217224|Superiority or Other||Proportion|0.1875||||0.043|1-Sided|95.0|0.053|||the a priori p-value was 0.05 for statistical significance|Exact Binomial|||The null hypothesis is that the proportion of participants in which the inhibitor level falls to less than 5 BU/mL between weeks 6 to 22 and remains below 5 BU/mL at 5-7 days following re-challenge with factor VIII is no more than 0.05|
1751219|NCT00330759|3217249|Superiority or Other||Hazard Ratio (HR)|0.9||||0.145||95.0|0.77|1.04|||Anderson-Gill model|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy||
1751220|NCT00330759|3217250|Superiority or Other||Hazard Ratio (HR)|0.84||||0.06||95.0|0.71|0.98|||Regression, Cox|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy||
1751221|NCT00330759|3217251|Non-Inferiority or Equivalence|A synthesis approach was used for a non-inferiority test of the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.84||||0.0007||95.0|0.71|0.98|||Regression, Cox|Stratified by tumor type, previous skeletal-related event, and systematic anti-cancer therapy|||
1751223|NCT00330551|3217290|Superiority||||||=|0|||||||ANOVA||||
1751227|NCT00330551|3217295|Superiority||||||=|0|||||||ANOVA|||A priori hypothesis was that long-acting injectible risperidone would lead to greater duration of work/school attendance than oral risperidone.|
1751228|NCT00330551|3217296|Superiority|||||||0.83|||||||Chi-squared||||
1751229|NCT00330551|3217297|Superiority||Risk Difference (RD)|11.1||||0.001|2-Sided||||||Chi-squared||||
1751230|NCT00330551|3217298|Superiority||t-test|0.77||||0.05|2-Sided|95.0|0.483|1.058|||t-test, 2 sided||||t(80)=5.3, p<.001
1751231|NCT00330460|3217299|Superiority or Other||Mean Difference (Final Values)|0.6||||0.0001||95.0|0.3|0.9||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA||||
1751232|NCT00330460|3217300|Non-Inferiority or Equivalence|Non-inferiority margin = -1.04%|Mean Difference (Final Values)|0.6|||<|0.0001||95.0|0.3|1.0||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA||||
1751233|NCT00330460|3217301|Non-Inferiority or Equivalence|Non-inferiority margin = -1.65%|Mean Difference (Final Values)|1.0|||<|0.0001||95.0|0.6|1.4||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA||||
1751234|NCT00330460|3217302|Non-Inferiority or Equivalence|Non-inferiority margin = -2.29%.|Mean Difference (Final Values)|1.1|||<|0.0001||95.0|0.7|1.4||The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints|ANCOVA||||
1751235|NCT00330460|3217303|Non-Inferiority or Equivalence|Non-inferiority margin = -1.22%.|Mean Difference (Final Values)|1.0|||<|0.0001||95.0|0.7|1.2|||ANCOVA||||
1751236|NCT00330382|3217311|Superiority or Other||Correlation Coefficient|0.07|||>|0.66|2-Sided||||||Spearman Rank Correlation|||Correlation of percent change in serum Neu with relative percent change in total lesion area|
1751237|NCT00330382|3217311|Superiority or Other||Correlation Coefficient|0.92|||>|0.88|2-Sided||||||Spearman Rank Correlation|||Correlation of percent change in protease activity with relative percent change in total lesion area|
1751238|NCT00330382|3217311|Superiority or Other||Correlation Coefficient|0.11|||>|0.45|2-Sided||||||Spearman Rank Correlation|||Correlation of percent change in buccal-cell Neu with relative percent change in total lesion area|
1751239|NCT00330187|3217321|Superiority||Odds Ratio (OR)|3.6||||0.07|2-Sided|95.0|0.9|14.4|||Regression, Logistic||||
1751240|NCT00330174|3217325|Superiority or Other|||||||0.64|||||||Mixed Models Analysis|||Drinking outcomes were analyzed using multiple linear regression, controlling for site and baseline drinking level. Drinking and psychiatric symptoms assessed over time were examined using repeated measures (intercept only) mixed linear models (PROC MIXED in SAS). Analyses were performed using SAS statistical software (version 9.2; SAS Institute, Inc., Cary, NC). All tests were two-tailed and p-values less than 0.05 were considered statistically significant.|
1751241|NCT00329901|3217342|Non-Inferiority or Equivalence|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus (Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|-7.0|||||2-Sided|95.0|-13.0|-2.0||||||Non-inferiority of anti-PRN antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo|
1751242|NCT00329901|3217342|Non-Inferiority or Equivalence|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus (Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|-3.0|||||2-Sided|95.0|-9.0|3.0||||||Non-inferiority of anti-FHA antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo|
1751243|NCT00329901|3217342|Non-Inferiority or Equivalence|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus (Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group difference|-5.0|||||2-Sided|95.0|-12.0|1.0||||||Non-inferiority of anti-PT antigen immune response following concomitant administration of Tdap with MenACWY as compared to Tdap given concomitantly with saline placebo|
1751244|NCT00329901|3217342|Non-Inferiority or Equivalence|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus(Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group Difference|1.0|||||2-Sided|95.0|-1.0|2.0||||||Non-inferiority of anti-tetanus immune response following concomitant administration of Tdap with MenACWY-CRM compared to Tdap given concomitantly with saline placebo|
1751245|NCT00329901|3217342|Non-Inferiority or Equivalence|The immune response to Tdap + MenACWY-CRM was considered non-inferior to that of Tdap+saline if for all five antigens (diphtheria, tetanus, PT, FHA, PRN) the lower limit of the 95% CI of the difference [(Tdap + MenACWY-CRM) minus(Tdap + saline)] was greater than -10, at 1 month (Day 29) after vaccination|Vaccine Group difference|9.0|||||2-Sided|95.0|5.0|14.0||||||Non-inferiority of anti-diphtheria immune response following concomitant administration of Tdap with MenACWY-CRM as compared to Tdap given with placebo saline|
1751246|NCT00329849|3217348|Non-Inferiority or Equivalence|Safety of MenACWY-CRM vaccination was considered non-inferior to the safety of MenACWY-PS vaccination if the upper limit of the two-sided 95% CI of the ratio (MenACWY-CRM group divided by MenACWY-PS group) of the percentage of subjects experiencing at least one severe systemic reaction during 1 to 7 days after vaccination was less than 3.|Group Ratio|6.37|||||2-Sided|95.0|0.82|49.2|||||||
1751247|NCT00329849|3217349|Non-Inferiority or Equivalence|The null hypothesis was that for the serogroup Y, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|18.0|||||2-Sided|95.0|8.0|28.0||||||Comparison of hSBA seroresponse for the serogroup Y one month after vaccination of MenACWY-CRM and MenACWY-PS|
1751383|NCT00325442|3218172|Superiority or Other||Hodges-Lehmann (H-L)|4.0||||0.889|2-Sided|95.0|-15.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16|
1751248|NCT00329849|3217349|Non-Inferiority or Equivalence|The null hypothesis was that for the serogroup W, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|28.0|||||2-Sided|95.0|17.0|39.0||||||Comparison of hSBA seroresponse for the serogroup W one month after vaccination of MenACWY-CRM and MenACWY-PS|
1751249|NCT00329849|3217349|Non-Inferiority or Equivalence|The null hypothesis was that for the serogroup C, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|30.0|||||2-Sided|95.0|19.0|40.0||||||Comparison of hSBA seroresponse for the serogroup C one month after vaccination of MenACWY-CRM and MenACWY-PS|
1751250|NCT00329849|3217349|Non-Inferiority or Equivalence|The null hypothesis was that for the serogroup A, the seroresponse percentage in the MenACWY-CRM group would be at least 10% lower than that in the MenACWY-PS group at one month postvaccination, i.e. the lower limit of the 95% CI of the difference in response rates (MenACWY-CRM minus MenACWY-PS) ≤-10%.|Group difference|38.0|||||2-Sided|95.0|29.0|47.0||||||Comparison of hSBA seroresponse for the serogroup A one month after vaccination of MenACWY-CRM and MenACWY-PS|
1751251|NCT00329797|3217352|Superiority|||||||0.63||||||significance level = 0.01|t-test, 2 sided|||Total|
1751252|NCT00329797|3217352|Superiority|||||||0.25||||||significance level = 0.01|t-test, 2 sided|||Functional subscale|
1751253|NCT00329797|3217352|Superiority|||||||0.51||||||significance level = 0.01|t-test, 2 sided|||Emotional subscale|
1751254|NCT00329797|3217352|Superiority|||||||0.82||||||significance level = 0.01|t-test, 2 sided|||Social subscale|
1751255|NCT00329797|3217352|Superiority|||||||0.33||||||significance level = 0.01|t-test, 2 sided|||Physical subscale|
1751256|NCT00329797|3217353|Superiority|||||||0.0007||||||significance level = 0.05|t-test, 2 sided|||Femoral - left|
1751257|NCT00329797|3217353|Superiority|||||||0.076||||||significance level = 0.05|t-test, 2 sided|||Femoral - right|
1751258|NCT00329797|3217353|Superiority|||||||0.0002||||||significance level = 0.05|t-test, 2 sided|||Hip - left|
1751259|NCT00329797|3217353|Superiority|||||||0.47||||||significance level = 0.05|t-test, 2 sided|||Hip - right|
1751260|NCT00329797|3217353|Superiority||||||<|0.0001||||||significance level = 0.05|t-test, 2 sided|||Lumbar|
1751261|NCT00329797|3217354|Superiority|||||||0.95|||||||Log Rank|||The study is designed to show a 40% relative reduction in the yearly ABF hazard rate, equivalent to an improvement in a 3-year FABF rate from 88% to 92.6%. A sample size of 1030 analyzable patients with a one-sided log-rank test at α = 0.05, was calculated to provide 80% statistical power, with one interim analysis and a final analysis for efficacy using Haybittle-Peto boundaries.|
1751262|NCT00329784|3217355|Superiority or Other|||||||0.262|||||||Chi-squared|||Comparison for Almond IgE|
1751263|NCT00329784|3217355|Superiority or Other|||||||0.04|||||||Chi-squared|||Comparison for Walnut IgE|
1751264|NCT00329784|3217355|Superiority or Other|||||||0.157|||||||Chi-squared|||Comparison for Cashew IgE|
1751265|NCT00329784|3217355|Superiority or Other|||||||0.108|||||||Chi-squared|||Comparison for Hazel Nut IgE|
1751266|NCT00329784|3217355|Superiority or Other|||||||0.202|||||||Chi-squared|||Comparison for Brazil Nut IgE|
1751267|NCT00329784|3217355|Superiority or Other|||||||0.106|||||||Chi-squared|||Comparison for Sesame IgE|
1751268|NCT00329784|3217355|Superiority or Other|||||||0.403|||||||Chi-squared|||Comparison for Milk IgE|
1751269|NCT00329784|3217355|Superiority or Other|||||||0.885|||||||Chi-squared|||Comparison for Egg IgE|
1751270|NCT00329784|3217355|Superiority or Other|||||||0.859|||||||Chi-squared|||Comparison for Peanut IgE|
1751271|NCT00329784|3217356|Superiority or Other|||||||0.194|||||||Chi-squared|||Comparison for Almond Wheal|
1751272|NCT00329784|3217356|Superiority or Other|||||||0.204|||||||Chi-squared|||Comparison for Walnut Wheal|
1751273|NCT00329784|3217356|Superiority or Other|||||||0.024|||||||Chi-squared|||Comparison for Cashew Wheal|
1751274|NCT00329784|3217356|Superiority or Other|||||||0.226|||||||Chi-squared|||Comparison for Hazel Nut Wheal|
1751275|NCT00329784|3217356|Superiority or Other|||||||0.882|||||||Chi-squared|||Comparison for Brazil Nut Wheal|
1751276|NCT00329784|3217356|Superiority or Other|||||||0.834|||||||Chi-squared|||Comparison for Sesame Wheal|
1751277|NCT00329784|3217356|Superiority or Other|||||||0.76|||||||Chi-squared|||Comparison for Milk Wheal|
1751278|NCT00329784|3217356|Superiority or Other|||||||0.361|||||||Chi-squared|||Comparison for Egg Wheal|
1751279|NCT00329784|3217356|Superiority or Other||||||<|0.001|||||||Chi-squared|||Comparison for Peanut Wheal|
1751280|NCT00329784|3217357|Superiority or Other|||||||0.926|||||||Chi-squared|||Comparison for Perennial Rhinoconjunctivitis|
1751281|NCT00329784|3217357|Superiority or Other|||||||0.417|||||||Chi-squared|||Comparison for Seasonal Rhinoconjunctivitis|
1751282|NCT00329784|3217358|Superiority or Other|||||||0.642|||||||Chi-squared||||
1751283|NCT00329784|3217359|Superiority or Other|||||||0.369|||||||Wilcoxon (Mann-Whitney)||||
1751284|NCT00329784|3217360|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1751285|NCT00329784|3217361|Superiority or Other|||||||0.004|||||||Chi-squared||||
1751286|NCT00329784|3217361|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1751287|NCT00329602|3217391|Superiority or Other|||||||0.023||||||P-value is for Week 26.|Repeated Measures Mixed Model|Adjusted for baseline IRLS Rating Scale total score, treatment group, visit, visit by treatment group interaction, and center group.|||
1751288|NCT00329602|3217391|Superiority or Other|||||||0.039||||||P-value is for Week 12.|Repeated Measures Mixed Model|Adjusted for baseline IRLS Rating Scale total score, treatment group, visit, visit by treatment group interaction, and center group.|||
1751289|NCT00329524|3217472|Superiority or Other|||||||0.05|||||||test for order effect||||
1751290|NCT00329524|3217473|Non-Inferiority or Equivalence|Power analysis based on paired t-test.|||||<|0.05|||||||t-test, 2 sided||||
1751291|NCT00329433|3217475|Superiority||||||<|0.05|||||||Fisher Exact||||
1751293|NCT00329433|3217477|Superiority or Other||||||<|0.05|||||||Fisher Exact|||Published data show that the incidence of PF4/heparin EIA antibodies is approximately 40% (range, 20% to 60%) following cardiac surgery. We estimated that antibody formation would occur in approximately 20% of patients following thoracic surgery. Sixty patients in each group would provide 80% power to detect a decrease in the incidence of positive PF4/heparin EIA tests from 20% to 4% at an alpha level of <0.05.|
1751294|NCT00329407|3217602|Superiority or Other||Mean Difference (Net)|-11.0|Standard Error of the Mean|2.7||0.001|1-Sided|95.0||||There would a significant reduction in COWAT scores between baseline and Week 10.|Mixed Models Analysis|The Dunnett-Hsu adjustment was used to correct for multiple comparisons.||This is a within subject comparison of COWAT scores botained for the baseline session and the Week 10 session. The null hypothesis is that there would be no difference between these scores.|
1751295|NCT00329407|3217603|Superiority or Other||Mean Difference (Final Values)|-4.7|Standard Error of the Mean|0.8|<|0.0001|2-Sided|95.0|-6.58|-3.14|||Mixed Models Analysis|The Dunnett-Hsu adjustment was used to correct for multiple comparisons.||This was a within subject analysis. The null hypothesis was that there would be no significant difference in least squares means values obtained for the baseline and week 10 assessment weeks.|
1751296|NCT00329238|3217684|Superiority or Other||Hazard Ratio (HR)|0.71|||<|0.0001|2-Sided|95.0|0.61|0.83|||Regression, Cox||This is the analysis of the time to the first occurrence of any bleeding event.|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.|
1751297|NCT00329238|3217684|Superiority or Other||Hazard Ratio (HR)|0.52|||<|0.0577||95.0|0.27|1.02|||Regression, Cox||This is the analysis of the time to the first MBE.|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors (including active cancer at baseline and symptomatic PE as qualifying event) and their interaction.|
1751298|NCT00329238|3217685|Superiority or Other||Risk Difference (RD)|-0.02||||0.9622||95.0|-0.89|0.84|||Kaplan-Meier|Risk difference for the time to all deaths at Month 18.||Dabigatran versus Warfarin|
1751299|NCT00329238|3217686|Superiority or Other||Hazard Ratio (HR)|0.9||||0.7405||95.0|0.47|1.72|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to all deaths|Dabigatran versus Warfarin|
1751300|NCT00329238|3217687|Superiority or Other||Risk Difference (RD)|0.01||||0.9204||95.0|-0.2|0.23|||Kaplan-Meier|Risk difference for the time to deaths related to VTE at Month 18.||Dabigatran versus Warfarin|
1751301|NCT00329238|3217688|Superiority or Other||Hazard Ratio (HR)|1.01||||0.9921||95.0|0.06|16.22|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to deaths related to VTE.|Dabigatran versus Warfarin|
1751302|NCT00329238|3217689|Superiority or Other||Risk Difference (RD)|0.26||||0.3723||95.0|-0.32|0.84|||Kaplan-Meier||Risk difference for the time to first centrally adjudicated recurrent symptomatic PE at Month 18|Dabigatran versus Warfarin|
1751303|NCT00329238|3217690|Superiority or Other||Hazard Ratio (HR)|2.04||||0.1925||95.0|0.7|5.98|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|Hazard ratio for time to first centrally adjudicated recurrent symptomatic PE.|Dabigatran versus Warfarin|
1751304|NCT00329238|3217691|Superiority or Other||Risk Difference (RD)|0.19||||0.6563||95.0|-0.63|1.0|||Kaplan-Meier|Risk difference for the time to first centrally adjudicated recurrent symptomatic DVT at Month 18.||Dabigatran versus Warfarin|
1751305|NCT00329238|3217692|Superiority or Other||Hazard Ratio (HR)|1.32||||0.4548||95.0|0.64|2.71|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|HR for time to first centrally adjudicated recurrent symptomatic DVT|Dabigatran versus Warfarin|
1751306|NCT00329238|3217693|Superiority or Other||Risk Difference (RD)|0.09||||0.8876||95.0|-1.11|1.28|||Kaplan-Meier|Risk difference for the time to first centrally adjudicated recurrent VTE or all cause death at month 18.||Dabigatran versus Warfarin|
1751307|NCT00329238|3217694|Superiority or Other||Hazard Ratio (HR)|1.18||||0.4732||95.0|0.75|1.84|||Regression, Cox|Hazard ratio estimated using the Cox regression with treatment, cohort, baseline stratification factors and their interaction.|HR for time to first centrally adjudicated recurrent VTE or all cause death.||
1751308|NCT00329238|3217695|Superiority or Other|||||||0.4013||||||p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the risk difference was then compared with 0 to evaluate the superiority claim of dabigatran over warfarin.|Kaplan-Meier||||
1751309|NCT00329238|3217695|Non-Inferiority or Equivalence|Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.|Risk Difference (RD)|0.38|||<|0.0001||95.0|-0.5|1.25||p-value for non-inferiority. The non-inferiority margin for the risk difference was chosen to be 2.80.|Regression, Cox|Risk difference for time to first recurrent VTE/VTE death is calculated based on weighted KM estimates across the cohorts via meta-analysis approach.|||
1751310|NCT00329238|3217696|Superiority or Other|||||||0.2424||||||p-value for superiority. If non-inferiority could be established for HR and for the risk difference, the upper bound of the 95% CI for the hazard ratio was then compared with 1 to evaluate the superiority claim of dabigatran over warfarin.|Regression, Cox||||
1751311|NCT00329238|3217696|Non-Inferiority or Equivalence|Comparisons between treatment groups were performed using a Cox regression analysis with treatment and baseline stratification factor in the model.|Hazard Ratio (HR)|1.44||||0.0137||95.0|0.78|2.64||p-value for non-inferiority. The non-inferiority margin for the hazard ratio was chosen to be 2.85.|Regression, Cox|HR within cohort estimated by Cox regr. with treatment and baseline stratific. factor. Overall HR calc. by pooling with inverse variance weighting.|HR for time to first recurrent VTE or VTE death.||
1751312|NCT00328627|3217856|Superiority or Other||LS Mean Difference|-0.61|||<|0.001|2-Sided|95.0|-0.83|-0.39|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|||
1751313|NCT00328627|3217856|Superiority or Other||LS Mean Difference|-0.7|||<|0.001|2-Sided|95.0|-0.92|-0.48|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|||
1751314|NCT00328627|3217856|Superiority or Other||LS Mean Difference|-0.55|||<|0.001|2-Sided|95.0|-0.77|-0.33|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|||
1751315|NCT00328627|3217856|Superiority or Other||LS Mean Difference|-0.91|||<|0.001|2-Sided|95.0|-1.13|-0.68|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|||
1751316|NCT00328627|3217856|Superiority or Other||LS Mean Difference|-0.47|||<|0.001|2-Sided|95.0|-0.7|-0.25|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|||
1751317|NCT00328627|3217856|Superiority or Other||LS Mean Difference|-0.49|||<|0.001|2-Sided|95.0|-0.71|-0.27|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|||
1751318|NCT00328627|3217856|Superiority or Other||LS Mean Difference|-0.47|||<|0.001|2-Sided|95.0|-0.7|-0.25|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|||
1751319|NCT00328627|3217856|Superiority or Other||LS Mean Difference|-0.76|||<|0.001|2-Sided|95.0|-0.98|-0.53|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|||
1751320|NCT00328627|3217856|Superiority or Other||LS Mean Difference|-0.52|||<|0.001|2-Sided|95.0|-0.74|-0.3|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|||
1751321|NCT00328627|3217856|Superiority or Other||LS Mean Difference|-0.37|||<|0.001|2-Sided|95.0|-0.59|-0.15|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|||
1751322|NCT00328627|3217856|Superiority or Other||LS Mean Difference|-0.59|||<|0.001|2-Sided|95.0|-0.81|-0.38|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|||
1751323|NCT00328627|3217856|Superiority or Other||LS Mean Difference|-0.7|||<|0.001|2-Sided|95.0|-0.93|-0.48||As a supportive analysis, each of the individual combination treatment groups was compared with the component treatment groups receiving aloliptin alone and pioglitazone alone at the 2-sided 0.05 significance level with no multiplicity adjustment.|ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|||
1751324|NCT00328627|3217888|Superiority or Other||LS Mean Difference|-0.53|||<|0.001|2-Sided|95.0|-0.66|-0.41|||ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.|||
1751325|NCT00328627|3217888|Superiority or Other||LS Mean Difference|-0.54|||<|0.001|2-Sided|95.0|-0.67|-0.41||For the primary analysis, the overall average HbA1c response of the Alogliptin/pioglitazone combination groups was compared with that of the pioglitazone alone groups at the 2-sided 0.05 significance level with no adjustment for multiple comparisons.|ANCOVA|ANCOVA model with treatment and geographic region as class variables, and baseline metformin dose and baseline HbA1c as continuous covariates.||The null hypothesis was that the doses of alogliptin do not have any additive effect on glycemic control (HbA1c) in addition to the effect produced by pioglitazone alone. The alternative hypothesis was that at least the higher dose of alogliptin would have an additive effect on glycemic control (HbA1c) in addition to the effect produced by pioglitazone alone.|
1751326|NCT00328172|3217906|Superiority or Other||Odds Ratio (OR)|5.224||||0.005||95.0|1.648|16.562|||Regression, Logistic|||Metformin versus placebo|
1751327|NCT00328172|3217906|Superiority or Other||Odds Ratio (OR)|1.844||||0.364||95.0|0.492|6.91|||Regression, Logistic|||Linagliptin 5.0 mg versus placebo|
1751328|NCT00328172|3217906|Superiority or Other||Odds Ratio (OR)|1.157||||0.842||95.0|0.275|4.861|||Regression, Logistic|||Linagliptin 2.5 mg versus placebo|
1751329|NCT00328172|3217906|Superiority or Other||Odds Ratio (OR)|1.735||||0.413||95.0|0.464|6.492|||Regression, Logistic|||Linagliptin 0.5 mg versus placebo|
1751330|NCT00328172|3217907|Superiority or Other||Mean Difference (Final Values)|-34.3|||<|0.0001||95.0|-47.0|-22.0|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.|||
1751331|NCT00328172|3217907|Superiority or Other||Mean Difference (Final Values)|-13.3|||<|0.0418||95.0|-26.0|-0.5|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 5.0 mg versus placebo|
1751332|NCT00328172|3217907|Superiority or Other||Mean Difference (Final Values)|-19.4|||<|0.003||95.0|-32.0|-6.6|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 2.5 mg versus placebo|
1751333|NCT00328172|3217907|Superiority or Other||Mean Difference (Final Values)|2.45|||<|0.7027||95.0|-10.0|15.1|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline FPG as a linear covariate.||Linagliptin 0.5 mg versus placebo|
1751334|NCT00328172|3217908|Superiority or Other||Mean Difference (Final Values)|-0.85|||<|0.0001||95.0|-1.1|-0.59|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Metformin versus placebo|
1751335|NCT00328172|3217908|Superiority or Other||Mean Difference (Final Values)|-0.46|||<|0.0012||95.0|-0.74|-0.18|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 5.0 mg versus placebo|
1751336|NCT00328172|3217908|Superiority or Other||Mean Difference (Final Values)|-0.42|||<|0.0032||95.0|-0.69|-0.14|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 2.5 mg versus placebo|
1751337|NCT00328172|3217908|Superiority or Other||Mean Difference (Final Values)|-0.14|||<|0.3271||95.0|-0.41|0.14|||ANCOVA|ANCOVA model includes treatment as a fixed classification effect and baseline HbA1c as a linear covariate.||Linagliptin 0.5 mg versus placebo|
1751338|NCT00328094|3217910|Superiority or Other||Risk Ratio (RR)|1.29||||0.23|2-Sided|95.0|0.85|1.97|||Chi-squared||||
1751339|NCT00327717|3217917|Superiority or Other|||||||0.678|||||||X^2 test||||
1751340|NCT00327717|3217918|Superiority or Other|||||||0.162|||||||X^2 test||||
1751341|NCT00327717|3217919|Superiority or Other|||||||0.09|||||||X^2 test||||
1751348|NCT00327444|3217934|Superiority or Other||Least squares (LS) Mean difference|-2.4|Standard Error of the Mean|0.94||0.0035|2-Sided|95.0|-4.33|-0.54||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=<2 weeks versus >2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=<2 weeks versus >2 weeks).|The LS mean difference is estimated for aflibercept versus placebo (aflibercept-placebo).||
1751349|NCT00327444|3217935|Superiority or Other||Least squares (LS) Mean difference|375.5|Standard Error of the Mean|205.99||0.016|2-Sided|95.0|-46.48|797.42||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=<2 weeks versus >2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=<2 weeks versus >2 weeks).|The LS mean difference was estimated for aflibercept versus placebo (aflibercept-placebo).||
1751350|NCT00327444|3217936|Superiority or Other||Least squares (LS) Mean difference|31.8|Standard Error of the Mean|10.59||0.0019|2-Sided|95.0|10.56|53.05||Estimated using Wilcoxon rank-sum test with stratification of baseline paracentesis (=<2 weeks versus >2 weeks) at randomization.|ANOVA|Estimated from ANOVA model with stratification of baseline paracentesis (=<2 weeks versus >2 weeks).|The LS mean difference is estimated for aflibercept versus placebo (aflibercept-placebo).||
1751351|NCT00327171|3217945|Superiority or Other||Hazard Ratio (HR)|1.124||||0.5457|2-Sided|95.0|0.77|1.64|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor (4 mg/kg vs. 2mg/kg)||
1751352|NCT00327171|3217946|Superiority or Other||Hazard Ratio (HR)|1.093||||0.5592|2-Sided|95.0|0.81|1.48|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor (4mg/kg vs. 2mg/kg)||
1751353|NCT00327171|3217949|Superiority or Other||Hazard Ratio (HR)|1.123||||0.5043|2-Sided|95.0|0.8|1.58|||Log Rank||Estimated using Cox proportional Hazard model using treatment as the factor||
1751354|NCT00326898|3218025|Superiority or Other||Hazard Ratio (HR)|0.98|||||2-Sided|97.5|0.75|1.28|||||Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.||
1751355|NCT00326898|3218025|Superiority or Other||Hazard Ratio (HR)|1.17|||||2-Sided|97.5|0.9|1.52|||||Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.||
1751356|NCT00326898|3218026|Superiority or Other||Hazard Ratio (HR)|0.97||||0.72|2-Sided|97.5|0.8|1.17|||Stratified logrank test|Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.|||
1751357|NCT00326898|3218026|Superiority or Other||Hazard Ratio (HR)|1.02||||0.8|2-Sided|97.5|0.85|1.23|||Stratified logrank test|Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.|||
1751358|NCT00326612|3218068|Superiority or Other||Odds Ratio (OR)|2.6||||||95.0|0.2|140.7|||||||
1751359|NCT00326612|3218069|Superiority or Other||Odds Ratio (OR)|0.8||||||95.0|0.0|67.3|||||||
1751360|NCT00326612|3218070|Superiority or Other||Odds Ratio (OR)|1.1||||||95.0|0.2|8.2|||||||
1751361|NCT00326612|3218071|Superiority or Other||Odds Ratio (OR)|1.1||||||95.0|0.4|2.7|||||||
1751362|NCT00326612|3218072|Superiority or Other||Odds Ratio (OR)|0.8||||||95.0|0.2|3.9|||||||
1751363|NCT00326612|3218073|Superiority or Other||Odds Ratio (OR)|0.8||||||95.0|||||||||
1751364|NCT00326001|3218122|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1751365|NCT00326001|3218123|Superiority or Other|||||||0.53|||||||Chi-squared||||
1751366|NCT00326001|3218124|Superiority or Other|||||||0.042|||||||Chi-squared||||
1751367|NCT00326001|3218125|Superiority or Other|||||||0.25||||||P-value not adjusted for multiple comparisons|t-test, 2 sided||||
1751368|NCT00325819|3218133|Superiority or Other||Risk Ratio (RR)|2.94||||0.18|2-Sided|95.0|0.6|14.34|||unadjusted Poisson regression||||
1751369|NCT00325819|3218134|Superiority or Other||Risk Ratio (RR)|1.0||||1|2-Sided|95.0|0.25|3.94|||unadjusted Poisson regression||||
1751370|NCT00325819|3218135|Superiority or Other||Risk Ratio (RR)|0.62||||0.4|2-Sided|95.0|0.21|1.88|||unadjusted Poisson regression||||
1751371|NCT00325819|3218136|Superiority or Other||Risk Ratio (RR)|0.4||||0.001|2-Sided|95.0|0.25|0.7|||unadjusted Poisson regression||||
1751372|NCT00325819|3218137|Superiority or Other||Risk Ratio (RR)|0.45||||0.14|2-Sided|95.0|0.16|1.28|||unadjusted Poisson regression||||
1751373|NCT00325819|3218138|Superiority or Other||Risk Ratio (RR)|0.31||||0.02|2-Sided|95.0|0.12|0.84|||unadjusted Poisson regression||||
1751374|NCT00325819|3218139|Superiority or Other||Risk Ratio (RR)|0.0||||0.08||95.0|||||Fisher Exact||||
1751375|NCT00325819|3218140|Superiority or Other||Risk Ratio (RR)|0.66||||0.053|2-Sided|95.0|0.41|1.01|||unadjusted Poisson regression|||The study sample size of 1000 children was selected to have 80% power to detect a 30% reduction in risk of the primary outcome of rectal temperature >=38 following vaccination. In 2009, during the enrollment period of our trial, another paper reported the results of a randomized trial of acetaminophen prophylaxis in infants which found significantly lower immune responses to various vaccines in the acetaminophen group. In light of thse findings we elected to stop enrollment in our trial.|
1751376|NCT00325442|3218164|Superiority or Other||Hodges-Lehmann (H-L)|10.0||||0.209|2-Sided|95.0|-6.0|28.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16|
1751377|NCT00325442|3218165|Superiority or Other||Hodges-Lehmann (H-L)|17.0||||0.23|2-Sided|95.0|-6.0|40.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16|
1751378|NCT00325442|3218166|Superiority or Other||Hodges-Lehmann (H-L)|5.0||||0.615|2-Sided|95.0|-12.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16|
1751379|NCT00325442|3218167|Superiority or Other||Hodges-Lehmann (H-L)|29.5||||0.085|2-Sided|95.0|1.0|73.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16|
1751380|NCT00325442|3218168|Superiority or Other||Hodges-Lehmann (H-L)|7.0||||0.327|2-Sided|95.0|-7.0|21.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16|
1751381|NCT00325442|3218169|Superiority or Other||Hodges-Lehmann (H-L)|5.0||||0.853|2-Sided|95.0|-16.0|28.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16|
1751382|NCT00325442|3218171|Superiority or Other||Hodges-Lehmann (H-L)|0.0||||0.966|2-Sided|95.0|-23.0|24.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16|
1752111|NCT00315445|3219620|Superiority or Other||Day 84 Mean|56.3|||||2-Sided|90.0|45.9|65.3|||||||
1751384|NCT00325442|3218173|Superiority or Other||Hodges-Lehmann (H-L)|15.0||||0.069|2-Sided|95.0|-7.0|41.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16|
1751385|NCT00325442|3218174|Superiority or Other||Hodges-Lehmann (H-L)|24.0||||0.121|2-Sided|95.0|0.0|45.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16|
1751386|NCT00325442|3218175|Superiority or Other||Hodges-Lehmann ( H-L)|4.0||||0.238|2-Sided|95.0|-2.4|12.0|||ANCOVA|||Change in 6MWD from Baseline to Week 4|
1751387|NCT00325442|3218176|Superiority or Other||Hodges-Lehmann|9.0||||0.051|2-Sided|95.0|0.0|18.0|||ANCOVA|||Change in 6MWD from Baseline to Week 8|
1751388|NCT00325442|3218177|Superiority or Other||Hodges-Lehmann (H-L)|13.0||||0.015|2-Sided|95.0|3.0|23.0|||ANCOVA|||Change in 6MWD from Baseline to Week 12|
1751389|NCT00325442|3218179|Superiority or Other||Hodges-Lehmann (H-L)|0.0||||0.011|2-Sided|95.0|0.0|1.0|||Wilcoxon sum-rank test|||Change in dyspnea-fatigue index from Baseline to Week 16|
1751390|NCT00325442|3218180|Superiority or Other|||||||0.491|||||||Fisher Exact||||
1751391|NCT00325442|3218181|Superiority or Other||Hodges-Lehmann (H-L)|0.0||||0.062|2-Sided|95.0|-1.0|0.0|||Wilcoxon rank-sum test|||Change in Borg dyspnea score from Baseline to Week 16|
1751392|NCT00325442|3218182|Superiority or Other||Hodges-Lehmann|11.0||||0.072|2-Sided|95.0|0.0|22.0|||ANCOVA|||Change in 6MWD from Baseline to Week 16|
1751393|NCT00325403|3218192|Superiority or Other||Hodges-Lehmann (H-L)|14.0||||0.0025|2-Sided|95.0|3.9|25.0|||ANCOVA||||
1751394|NCT00325403|3218193|Superiority or Other||Hodges-Lehmann (H-L)|20.0||||0.0008|2-Sided|95.0|7.0|34.0|||ANCOVA||||
1751395|NCT00325403|3218194|Superiority or Other||Hodges-Lehmann (H-L)|17.0||||0.0025|2-Sided|95.0|3.0|33.0|||ANCOVA||||
1751396|NCT00325403|3218195|Superiority or Other||Hodges-Lehmann (H-L)|25.5||||0.0001|2-Sided|95.0|10.0|41.0|||ANCOVA||||
1751397|NCT00325403|3218196|Superiority or Other||Hodges-Lehmann (H-L)|32.0||||0.0024|2-Sided|95.0|10.0|55.0|||ANCOVA||||
1751398|NCT00325403|3218197|Superiority or Other||Hodges-Lehmann (H-L)|16.0||||0.2275|2-Sided|95.0|-15.0|47.0|||ANCOVA||||
1751399|NCT00325403|3218198|Superiority or Other||Hodges-Lehmann (H-L)|26.0||||0.0326|2-Sided|95.0|1.0|49.0|||ANCOVA||||
1751400|NCT00325403|3218200|Superiority or Other||Hodges-Lehmann (H-L)|0.0||||0.6116|2-Sided|95.0|0.0|1.0|||Wilcoxon sum-rank test||||
1751401|NCT00325403|3218201|Superiority or Other||Hodges-Lehmann (H-L)|0.0||||0.4887|2-Sided|95.0|-1.0|0.0|||Wilcoxon rank-sum test||||
1751402|NCT00325403|3218202|Superiority or Other||Hodges-Lehmann (H-L)|0.0||||0.738|2-Sided|95.0|0.0|0.0||In cases where the “value corresponding to overall poorest relative change” was imputed for walk distance, a value of “IV” was used for the WHO functional classification for PAH.|Wilcoxon rank sum test||The values for the estimated parameter and 95% confidence interval were calculated.||
1751403|NCT00325403|3218203|Superiority or Other|||||||1|||||||Fisher Exact||||
1751404|NCT00325403|3218204|Superiority or Other||Hodges-Lehmann (H-L)|12.0||||0.0518|2-Sided|95.0|0.0|24.0|||ANCOVA||||
1751405|NCT00325403|3218205|Superiority or Other||Hodges-Lehmann (H-L)|17.0||||0.0307|2-Sided|95.0|1.0|33.0|||ANCOVA||||
1751406|NCT00325403|3218206|Superiority or Other||Hodges-Lehmann (H-L)|13.0||||0.0653|2-Sided|95.0|-2.0|33.0|||ANCOVA||||
1751407|NCT00325403|3218207|Superiority or Other||Hodges-Lehmann (H-L)|23.0||||0.0125|2-Sided|95.0|4.0|41.0||P-Value|ANCOVA|||Using an allocation ratio of 2:1 between oral treprostinil and placebo, a fixed sample size of approximately 195 subjects with access to 0.25 mg tablets at randomization would provide at least 90% power at a significance level of 0.01 (two-sided hypothesis) to detect a between-treatment difference in the change from Baseline to Week 12 in distance traversed during the 6-minute walk, assuming a true underlying treatment difference of 45 meters with a SD of 75 meters in both treatment groups.|
1751408|NCT00325195|3218215|Superiority or Other|||||||0.024|||||||t-test, 2 sided||||
1751409|NCT00325195|3218215|Superiority or Other|||||||0.008|||||||t-test, 2 sided||||
1751410|NCT00325195|3218216|Superiority or Other|||||||0.17|||||||t-test, 2 sided||||
1751411|NCT00325195|3218216|Superiority or Other|||||||0.166|||||||t-test, 2 sided||||
1751412|NCT00325195|3218217|Superiority or Other|||||||0.321|||||||Fisher Exact|||% of pegloticase q4 participants reporting flares compared to placebo pts during Months 4-6 treatment period|
1751413|NCT00325195|3218217|Superiority or Other|||||||0.007|||||||Fisher Exact|||% of pegloticase q2 participants reporting flares compared to placebo pts during Months 4-6 treatment period|
1751414|NCT00325195|3218218|Superiority or Other|||||||0.2|||||||Fisher Exact||||
1751415|NCT00325195|3218218|Superiority or Other||||||<|0.002|||||||Fisher Exact||||
1751416|NCT00325195|3218219|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1751417|NCT00325195|3218219|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1751418|NCT00325130|3218229|Non-Inferiority or Equivalence|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1751419|NCT00325130|3218230|Non-Inferiority or Equivalence|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1751420|NCT00325130|3218231|Non-Inferiority or Equivalence|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1751421|NCT00325130|3218232|Non-Inferiority or Equivalence|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.67."|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1751422|NCT00325130|3218233|Non-Inferiority or Equivalence|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1751423|NCT00325130|3218234|Non-Inferiority or Equivalence|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1751424|NCT00325130|3218235|Non-Inferiority or Equivalence|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1751425|NCT00325130|3218236|Non-Inferiority or Equivalence|"The ratio of GMTs (concomitant group / nonconcomitant group)~must be greater than 0.5."|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|ANOVA|ANOVA on natural log titer with fixed effects for region, vaccination group and their interaction.|||
1751426|NCT00325130|3218237|Non-Inferiority or Equivalence|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen & Nurminen method for difference in proportions, Stat Med 1985;4:213-26|||
1751427|NCT00325130|3218238|Non-Inferiority or Equivalence|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen & Nurminen method for difference in proportions, Stat Med 1985;4:213-26|||
1751428|NCT00325130|3218239|Non-Inferiority or Equivalence|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen & Nurminen method for difference in proportions, Stat Med 1985;4:213-26|||
1751429|NCT00325130|3218240|Non-Inferiority or Equivalence|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen & Nurminen method for difference in proportions, Stat Med 1985;4:213-26|||
1751430|NCT00325130|3218241|Non-Inferiority or Equivalence|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen & Nurminen method for difference in proportions, Stat Med 1985;4:213-26|||
1751431|NCT00325130|3218242|Non-Inferiority or Equivalence|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -10%"|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen & Nurminen method for difference in proportions, Stat Med 1985;4:213-26|||
1751432|NCT00325130|3218243|Non-Inferiority or Equivalence|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen & Nurminen method for difference in proportions, Stat Med 1985;4:213-26|||
1751433|NCT00325130|3218244|Non-Inferiority or Equivalence|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen & Nurminen method for difference in proportions, Stat Med 1985;4:213-26|||
1751434|NCT00325130|3218245|Non-Inferiority or Equivalence|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen & Nurminen method for difference in proportions, Stat Med 1985;4:213-26|||
1751435|NCT00325130|3218247|Non-Inferiority or Equivalence|"The difference in seroconversion rates (concomitant group -~nonconcomitant group) must be greater than -5%"|||||<|0.001||||||Since p<0.05, the hypothesis of noninferiority is accepted for this outcome.|Miettinen & Nurminen|Miettinen & Nurminen method for difference in proportions, Stat Med 1985;4:213-26|||
1751436|NCT00325039|3218251|Superiority or Other|||||||0.41|||||||t-test, 2 sided|||The UDI measure was compared using a two-sample t test.|
1751437|NCT00325039|3218252|Superiority or Other|||||||0.47|||||||t-test, 2 sided|||The null hypothesis is that the two arms do not differ according to quality of life, as measured by the IIQ.|
1751438|NCT00325039|3218253|Non-Inferiority or Equivalence|This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.|difference in success (RMUS - TMUS)|6.4|||||2-Sided|95.0|-1.6|14.3||||||With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.|
1751439|NCT00325039|3218254|Superiority or Other||Difference in proportions|-4.1||||0.14||95.0||||This was not adjusted for multiple comparisons; the a priori threshold for statistical significance was 0.05.|Chi-squared|||Although the primary aim of the study was designed as an equivalence trial, the secondary aims were considered as superiority tests.|
1751440|NCT00325039|3218255|Non-Inferiority or Equivalence|This study was an equivalence trial and was designed to have 80% power to show equivalence between the two sling procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. The margin of +/- 12 was chosen on the basis of clinical considerations and a calculation of the number of patients it was feasible to enroll in the trial.|difference in success rate (RMUS-TMUS)|3.0|||||2-Sided|95.0|-3.6|9.6||||||With 294 women/arm, the study would have 80% power to show equivalence between the two procedures, with an equivalence margin of +/- 12 percentage points, at a two-sided significance level of 5%. A planned time-to-event interim analysis of the primary outcome (objective treatment success) was conducted when 33% of the anticipated treatment failures occurred. We adjusted the primary outcome analysis for this interim look by assigning nominal alpha values of 0.049 to the 95% confidence intervals.|
1751441|NCT00324857|3218277|Superiority or Other||||||<|0.05||||||"Please note that although the outcome is measured using a Likert scale, for the analysis we dichotomized the results.~P-value not adjusted for multiple comparison. Lastly, <0.05 is the actual computed P-value."|Regression, Logistic|||Comparisons of the baseline demographic and clinical characteristics (TKR) across the 4 intervention groups were performed using chi-square tests for categorical data and analysis of variance for continuous variables. Willingness were compared across the groups over time using mixed-effect logistic regressions for dichotomous outcomes.|
1751442|NCT00324805|3218281|Superiority||Hazard Ratio (HR)|0.99||||0.95|2-Sided|95.0|0.86|1.15|||Regression, Cox||Arm II vs. Arm I||
1751443|NCT00324805|3218282|Superiority||Hazard Ratio (HR)|0.99||||0.9|2-Sided|95.0|0.82|1.19|||Regression, Cox||Arm II versus Arm I||
1751444|NCT00324753|3218285|Superiority|||||||0.005||||||p-value based on a test of any treatment difference by site.|Mixed Models Analysis|The model was run using the xtlogit command in Stata and was adjusted for all of the reported baseline characteristics.|||
1751445|NCT00324649|3218298|Superiority or Other|||||||0.1785||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751446|NCT00324649|3218299|Superiority or Other|||||||0.0006||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751447|NCT00324649|3218300|Superiority or Other|||||||0.0072||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751448|NCT00324649|3218301|Superiority or Other|||||||0.2907||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751449|NCT00324649|3218302|Superiority or Other|||||||0.6638||||||No adjustments for multiple comparisons were performed.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751450|NCT00324649|3218303|Superiority or Other|||||||0.9686||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751451|NCT00324649|3218304|Superiority or Other|||||||0.9633||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751452|NCT00324649|3218305|Superiority or Other|||||||0.0789||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751453|NCT00324649|3218308|Superiority or Other||Mean Difference (Net)|14.3||||0.1165||95.0|-0.9|29.4||No adjustments for multiple comparisons were made.|Fisher Exact|No adjustments were made.|The difference is for Truvada minus zidovudine/lamivudine. The 95% confidence interval on the mean difference between treatment groups is based on the normal approximation.|"Null Hypothesis: treatment is not associated with the observed virologic response.~Alternative Hypothesis: treatment is associated with the observed virologic response."|
1751454|NCT00324649|3218309|Superiority or Other|||||||0.6984||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: percentages of days with compliance in the two treatment groups are equal. Alternative Hypothesis: percentages of days with compliance in the two treatment groups are different (two sided).|
1751455|NCT00324649|3218310|Superiority or Other|||||||0.0078||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751456|NCT00324649|3218311|Superiority or Other|||||||0.9725||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751457|NCT00324649|3218312|Superiority or Other|||||||0.9713||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751458|NCT00324649|3218313|Superiority or Other|||||||0.0014||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751459|NCT00324350|3218325|Superiority or Other||Odds Ratio (OR)|0.99||||0.854|2-Sided|95.0|0.88|1.11|||Mixed Models Analysis||The rate of height loss did not differ between groups (p = 0.573). Height loss of >2 cm during ACCORD was experienced by 678 (19.5%) participants in the intensive and 686 (19.6%) in the standard glycemia group (OR 0.99; 95% CI 0.88, 1.11).|Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. The proportions losing >2 cm of height during follow-up were compared using logistic models. Based on previous research by Siminoski et al., this degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity.(Siminoski K, Jiang G, Adachi JD, et al. Osteoporos Int 2005;16:403–410)|
1751501|NCT00324168|3218356|Superiority or Other||Mean Difference (Net)|-0.009||||0.82|2-Sided|95.0|-0.085|0.068|||Regression, Linear|Adjusted for enrollment BSCVA|||
1751551|NCT00323609|3218435|Superiority or Other|||||||0.996||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 24 months|
1751460|NCT00324350|3218326|Superiority or Other||Risk Ratio (RR)|1.1||||0.49|2-Sided|95.0|0.84|1.43|||Regression, Cox|||Number of participants with falls reported at each annual visit were compared by treatment assignment using a repeated-measures negative binomial model, with robust standard errors to account for clustering of the repeated outcomes within participants; the log of the length of the reporting period varied slightly and was included as an offset|
1751461|NCT00324350|3218327|Superiority or Other||Hazard Ratio (HR)|1.04||||0.678|2-Sided|95.0|0.86|1.27||Analyses were by intention to treat. All analyses adjusted for baseline cardiovascular disease, assignment to blood pressure (BP) trial or lipid trial, assignment to intensive BP intervention in BP trial, and assignment to fibrate in lipid trial.|Regression, Cox|||The BONE ancillary study was designed to have 80% power to detect a relative reduction in risk of non-spine clinical fractures of 22-29%. This was based on an estimated total number of fractures between 259-494, calculated with the following assumptions: rate of clinical non-spine fracture among women in the standard glycemia therapy group between 15 and 25/1000 person yrs, fracture rates for men between 35-40% of the rates for women of the same age, and an avg follow-up time of 4.6 yrs.|
1751462|NCT00324272|3218328|Superiority or Other||Hazard Ratio (HR)|0.923||||0.923|2-Sided|95.0|0.05|13.95|||Regression, Cox|||Death from an unrelated cause in the axillary cohort.|
1751463|NCT00324272|3218328|Superiority or Other||Hazard Ratio (HR)|0.93||||0.88|2-Sided|95.0|0.35|2.47|||Regression, Cox|||Death from metastatic disease in the axillary cohort.|
1751464|NCT00324272|3218328|Superiority or Other||Hazard Ratio (HR)|0.33||||0.338|2-Sided|95.0|0.03|3.2|||Regression, Cox|||Death from an unrelated cause in the groin cohort.|
1751465|NCT00324272|3218328|Superiority or Other||Hazard Ratio (HR)|1.02||||0.963|2-Sided|95.0|0.4|2.58|||Regression, Cox|||Death from metastatic disease in the groin cohort.|
1751466|NCT00324272|3218329|Superiority or Other|||||||0.486|||||||Fisher Exact|||Distant metastasis in the axillary cohort (with the patient being alive at the end of the study follow-up period on 1.6.10).|
1751467|NCT00324272|3218329|Superiority or Other|||||||1|||||||Fisher Exact|||In transit or regional recurrence in the axillary cohort.|
1751468|NCT00324272|3218329|Superiority or Other|||||||0.606|||||||Fisher Exact|||Local recurrence in the groin cohort.|
1751469|NCT00324272|3218329|Superiority or Other|||||||0.474|||||||Fisher Exact|||Distant metastasis in the groin cohort (with the patient being alive at the end of the study follow-up period on 1.6.10).|
1751470|NCT00324272|3218329|Superiority or Other|||||||0.301|||||||Fisher Exact|||In transit or regional recurrence in the groin cohort.|
1751471|NCT00324272|3218329|Superiority or Other|||||||1|||||||Fisher Exact|||Local recurrence in the groin cohort.|
1751472|NCT00324272|3218330|Superiority or Other|||||||0.4|||||||Wilcoxon (Mann-Whitney)||||
1751473|NCT00324272|3218330|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1751474|NCT00324272|3218331|Superiority or Other|||||||0.48|||||||Fisher Exact||||
1751475|NCT00324272|3218331|Superiority or Other|||||||0.351|||||||Fisher Exact||||
1751476|NCT00324272|3218332|Superiority or Other|||||||0.426|||||||t-test, 2 sided||||
1751477|NCT00324272|3218332|Superiority or Other|||||||0.988|||||||t-test, 2 sided||||
1751478|NCT00324272|3218334|Superiority or Other|||||||0.217|||||||t-test, 2 sided||||
1751479|NCT00324272|3218334|Superiority or Other|||||||0.704|||||||t-test, 2 sided||||
1751480|NCT00324233|3218345|Superiority or Other|||||||0.56|||||||equivalence testing||||
1751481|NCT00324168|3218346|Superiority or Other||Mean Difference (Net)|-0.15||||0.07|2-Sided|95.0|-0.31|0.01|||Regression, Linear|||4.07-8.90 mm|
1751482|NCT00324168|3218346|Superiority or Other||Mean Difference (Net)|0.03||||0.7|2-Sided|95.0|-0.12|0.18|||Regression, Linear|||2.71-4.06 mm|
1751483|NCT00324168|3218346|Superiority or Other||Mean Difference (Net)|0.0||||0.95|2-Sided|95.0|-0.15|0.16|||Regression, Linear|||1.91-2.70 mm|
1751484|NCT00324168|3218346|Superiority or Other||Mean Difference (Net)|0.05||||0.53|2-Sided|95.0|-0.1|0.2|||Regression, Linear|||0-1.90 mm|
1751485|NCT00324168|3218347|Superiority or Other||Mean Difference (Net)|-0.15||||0.07|2-Sided|95.0|-0.31|0.01|||Regression, Linear|||>67%-100%|
1751486|NCT00324168|3218347|Superiority or Other||Mean Difference (Net)|0.01||||0.94|2-Sided|95.0|-0.13|0.14|||Regression, Linear|||>33%-67%|
1751487|NCT00324168|3218347|Superiority or Other||Mean Difference (Net)|0.06||||0.31|2-Sided|95.0|-0.05|0.17|||Regression, Linear|||>0-33%|
1751488|NCT00324168|3218348|Superiority or Other||Mean Difference (Net)|-0.17||||0.03|2-Sided|95.0|-0.31|-0.02|||Regression, Linear|||CF or worse|
1751489|NCT00324168|3218348|Superiority or Other||Mean Difference (Net)|0.01||||0.85|2-Sided|95.0|-0.09|0.11|||Regression, Linear|||20/40 to 20/800|
1751490|NCT00324168|3218348|Superiority or Other||Mean Difference (Net)|0.08||||0.33|2-Sided|95.0|-0.08|0.25|||Regression, Linear|||<20/40|
1751491|NCT00324168|3218349|Superiority or Other||Mean Difference (Net)|-0.04||||0.67|2-Sided|95.0|-0.2|0.13|||Regression, Linear|||Pseudomonas aeruginosa|
1751492|NCT00324168|3218349|Superiority or Other||Mean Difference (Net)|0.1||||0.65|2-Sided|95.0|-0.34|0.55|||Regression, Linear|||Moraxella spp|
1751493|NCT00324168|3218349|Superiority or Other||Mean Difference (Net)|-0.01||||0.86||95.0|-0.12|0.1|||Regression, Linear|||Streptococcus pneumoniae|
1751494|NCT00324168|3218349|Superiority or Other||Mean Difference (Net)|0.12||||0.3|2-Sided|95.0|-0.011|0.35|||Regression, Linear|||Nocardia spp|
1751495|NCT00324168|3218350|Superiority or Other||Mean Difference (Net)|-0.01|Standard Error of the Mean|0.04||0.78||95.0|-0.09|0.07|||Regression, Linear||||
1751496|NCT00324168|3218351|Superiority or Other||Mean Difference (Net)|-0.04||||0.39|2-Sided|95.0|-0.12|0.05|||Regression, Linear||||
1751497|NCT00324168|3218352|Superiority or Other||||||>|0.99|||||||Fisher Exact||||
1751498|NCT00324168|3218353|Superiority or Other||Hazard Ratio (HR)|0.92||||0.44|2-Sided|95.0|0.76|1.12|||Regression, Cox||||
1751499|NCT00324168|3218354|Superiority or Other||Mean Difference (Net)|0.01||||0.873|2-Sided|95.0|-0.07|0.08|||Regression, Linear||||
1751500|NCT00324168|3218355|Superiority or Other||Mean Difference (Net)|0.06||||0.4|2-Sided|95.0|-0.09|0.15|||Regression, Linear||||
1752112|NCT00315445|3219620|Superiority or Other||Day 84 Mean|55.3|||||2-Sided|90.0|49.8|67.9|||||||
1751502|NCT00324155|3218360|Superiority or Other||Hazard Ratio (HR)|0.716||||0.0009|2-Sided|95.0|0.588|0.872||p-value was via stratified log-rank test|Log Rank||Hazard ratio via stratified Cox proportional hazards model.|Analysis stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and Eastern Cooperative Oncology Group performance status (0 vs 1) recorded at randomization.|
1751503|NCT00324155|3218368|Superiority or Other||Odds Ratio (OR)|1.179||||0.4067|2-Sided|95.0|0.799|1.74|||Cochran-Mantel-Haenszel|Stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and ECOG performance status (0 vs 1) recorded at randomization.||Analysis stratified for metastasis stage (M0 vs M1a vs M1b vs M1c) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1) recorded at randomization.|
1751504|NCT00324116|3218371|Superiority or Other||percentage of subjects|25.97||||||95.0|16.28|34.81|||||Proportion of subjects progressing to <=20/200 was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.||
1751505|NCT00324116|3218372|Superiority or Other||percentage of subjects|13.75||||||95.0|7.39|22.24|||||Proportion of subjects with severe visual loss was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.||
1751506|NCT00324116|3218373|Superiority or Other||percentage of subjects|22.5||||||95.0|14.22|32.11|||||Proportion of subjects maintaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations.||
1751507|NCT00324116|3218374|Superiority or Other||percentage of subjects|5.0||||||95.0|1.61|11.32|||||Proportion of subjects gaining vision was estimated on an observed case basis. Percentage denominator = total number of subjects in the FAS. 95% confidence intervals were calculated from Fleiss quadratic equations||
1751508|NCT00324116|3218375|Superiority or Other||Mean Difference (Net)|-11.12||||||95.0|-16.28|-5.96|||||95% CI for the change in mean value obtained from one sample t-test.|54 weeks|
1751509|NCT00324116|3218375|Superiority or Other||Mean Difference (Net)|-5.86||||||95.0|-9.06|-2.67|||||95% CI for the change in mean value obtained from one sample t-test.|12 weeks|
1751510|NCT00324116|3218375|Superiority or Other||Mean Difference (Net)|-4.29||||||95.0|-6.83|-1.75|||||95% CI for the change in mean value obtained from one sample t-test.|6 weeks|
1751511|NCT00324116|3218376|Superiority or Other||percent responders|85.0||||||95.0|76.0|95.0|||||Proportion of responders estimated by Kaplan-Meier analysis. Proportion of responders along with 95% CI calculated directly from estimate of survival distribution function. Percentage denominator = total number of subjects without missing data.||
1751512|NCT00323622|3218417|Superiority or Other||1 - (R1/R2)|6.31||||0.7|2-Sided|95.0|-31.0|32.99||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).|
1751513|NCT00323622|3218417|Superiority or Other||1 - (R1/R2)|16.79||||0.1|2-Sided|95.0|-3.75|33.25||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).|
1751514|NCT00323622|3218418|Superiority or Other||1 - (R1/R2)|7.08||||0.54|2-Sided|95.0|-17.37|26.44||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).|
1751515|NCT00323622|3218418|Superiority or Other||1 - (R1/R2)|19.42||||0.01|2-Sided|95.0|4.62|31.93||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).|
1751516|NCT00323622|3218419|Superiority or Other||1 - (R1/R2)|12.79||||0.35|2-Sided|95.0|-16.27|34.59||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).|
1751517|NCT00323622|3218419|Superiority or Other||1 - (R1/R2)|14.9||||0.11|2-Sided|95.0|-3.88|30.28||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).|
1752113|NCT00315445|3219623|Superiority or Other||Day 84 Mean|57.7|||||2-Sided|90.0|52.3|58.6|||||||
1751518|NCT00323622|3218420|Superiority or Other||1 - (HR1/HR2)|11.8||||0.43|2-Sided|95.0|-20.11|35.18||The p-value presented is the Wald Chi-square p-value from the Cox regression model|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).|
1751519|NCT00323622|3218420|Superiority or Other||1 - (HR1/HR2)|16.8||||0.08|2-Sided|95.0|-2.5|32.4||The p-value presented is the Wald Chi-square p-value from the Cox regression model.|Regression, Cox|Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.||The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 - GSK RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).|
1751520|NCT00323609|3218426|Superiority or Other|||||||0.687||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.|
1751521|NCT00323609|3218426|Superiority or Other|||||||0.565||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.|
1751522|NCT00323609|3218426|Superiority or Other|||||||0.745||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.|
1751523|NCT00323609|3218426|Superiority or Other|||||||0.472||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at pre-discharge.|
1751524|NCT00323609|3218427|Superiority or Other|||||||0.036||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.|
1751525|NCT00323609|3218427|Superiority or Other|||||||0.089||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.|
1751526|NCT00323609|3218427|Superiority or Other|||||||0.933||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.|
1751527|NCT00323609|3218427|Superiority or Other|||||||0.663||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at pre-discharge.|
1751528|NCT00323609|3218428|Superiority or Other|||||||0.79||||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.|
1751529|NCT00323609|3218428|Superiority or Other|||||||0.631||||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.|
1751530|NCT00323609|3218428|Superiority or Other|||||||0.981||||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.|
1751531|NCT00323609|3218428|Superiority or Other|||||||0.033||||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.|
1751532|NCT00323609|3218429|Superiority or Other|||||||0.281||||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.|
1751533|NCT00323609|3218429|Superiority or Other|||||||0.196||||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.|
1751534|NCT00323609|3218429|Superiority or Other|||||||0.382||||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.|
1751535|NCT00323609|3218429|Superiority or Other|||||||0.005||||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.|
1751536|NCT00323609|3218430|Superiority or Other|||||||0.1||||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 24 months.|
1751537|NCT00323609|3218430|Superiority or Other|||||||0.185||||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 12 months.|
1751538|NCT00323609|3218430|Superiority or Other|||||||0.364||||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at 3 months.|
1751539|NCT00323609|3218430|Superiority or Other|||||||0.112||||||P-value was obtained from ANCOVA with Absolute Height Loss (AHL) as covariate.|ANCOVA|||Statistical analysis at pre-discharge.|
1751540|NCT00323609|3218431|Superiority or Other|||||||1|||||||Fisher Exact||||
1751541|NCT00323609|3218432|Superiority or Other|||||||0.226|||||||Fisher Exact||||
1751542|NCT00323609|3218433|Superiority or Other|||||||0.818|||||||Fisher Exact||||
1751543|NCT00323609|3218434|Superiority or Other|||||||0.457||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.|
1751544|NCT00323609|3218434|Superiority or Other|||||||0.634||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.|
1751545|NCT00323609|3218434|Superiority or Other|||||||0.523||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.|
1751546|NCT00323609|3218434|Superiority or Other|||||||0.318||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days.|
1751547|NCT00323609|3218435|Superiority or Other|||||||0.722||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 24 months|
1751548|NCT00323609|3218435|Superiority or Other|||||||0.393||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 12 months|
1751549|NCT00323609|3218435|Superiority or Other|||||||0.576||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 3 months|
1751550|NCT00323609|3218435|Superiority or Other|||||||0.983||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 MCS result at 30 days|
1751552|NCT00323609|3218435|Superiority or Other|||||||0.291||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 12 months|
1751553|NCT00323609|3218435|Superiority or Other|||||||0.822||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 3 months|
1751554|NCT00323609|3218435|Superiority or Other|||||||0.18||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis of SF-36 PCS result at 30 days.|
1751555|NCT00323609|3218436|Superiority or Other|||||||0.833||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.|
1751556|NCT00323609|3218436|Superiority or Other|||||||0.875||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months|
1751557|NCT00323609|3218436|Superiority or Other|||||||0.393||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.|
1751558|NCT00323609|3218436|Superiority or Other|||||||0.785||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days|
1751559|NCT00323609|3218437|Superiority or Other|||||||0.837||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 24 months.|
1751560|NCT00323609|3218437|Superiority or Other|||||||0.503||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 12 months.|
1751561|NCT00323609|3218437|Superiority or Other|||||||0.756||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 3 months.|
1751562|NCT00323609|3218437|Superiority or Other|||||||0.655||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 30 days.|
1751563|NCT00323609|3218437|Superiority or Other|||||||0.43||||||P-value was obtained from ANCOVA with baseline value as covariate.|ANCOVA|||Statistical analysis at 7 days.|
1751564|NCT00323609|3218438|Superiority or Other|||||||0.214|||||||Fisher Exact||||
1751565|NCT00323492|3218442|Superiority or Other|||||||1||||||No adjustments were made.|Fisher Exact|No adjustments were made.||Null Hypothesis: treatment is not associated with the observed virologic response. Alternative Hypothesis: treatment is associated with the observed virologic response|
1751566|NCT00323492|3218443|Superiority or Other|||||||0.34||||||No adjustments were made.|Wilcoxon Signed Rank test|No adjustments were made.||Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.|
1751567|NCT00323492|3218443|Superiority or Other|||||||0.11||||||No adjustments were made.|Wilcoxon Signed Rank test|No adjustments were made.||Null Hypothesis: no indication of shift from 0 in distribution of change from baseline. Alternative Hypothesis: shift from 0 is observed in distribution of change from baseline.|
1751568|NCT00323492|3218444|Superiority or Other|||||||0.65||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751569|NCT00323492|3218446|Superiority or Other|||||||0.86||||||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.||Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751570|NCT00323492|3218447|Superiority or Other||Median Difference (Net)|0.0||||0.79||95.0|-0.03|0.02||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751571|NCT00323492|3218448|Superiority or Other||Median Difference (Net)|-0.1||||0.51||95.0|-0.44|0.19||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751572|NCT00323492|3218449|Superiority or Other||Median Difference (Net)|-0.64|||<|0.001||95.0|-1.01|-0.27||No adjustments for multiple comparisons were made.|Wicoxon Rank Sum test|no adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751573|NCT00323492|3218450|Superiority or Other||Median Difference (Net)|-0.1||||0.009||95.0|-0.18|-0.02||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751574|NCT00323492|3218451|Superiority or Other||Median Difference (Net)|-0.36||||0.031||95.0|-0.67|-0.03||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum text|No adjustments were made.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751655|NCT00322153|3218691|Superiority or Other||Mean Difference (Final Values)|2.6||||0.001|2-Sided|95.0|1.0|4.2|||ANCOVA|Least-squares mean (-0.4 in placebo and 2.2 in memantine ER) are controlled for center and adjusted for SIB baseline value.||The co-primary efficacy parameter was change from Baseline to Week 24 in SIB total score. Missing SIB total scores at Week 24 were imputed using the last-observation-carried-forward (LOCF) approach.|
1751575|NCT00323492|3218452|Superiority or Other||Median Difference (Net)|-0.42||||0.034||95.0|-0.86|-0.03||No adjustments for multiple comparisons were made.|Wilcoxon Rank Sum test|No adjustments were applied.|Difference is for Truvada minus Maintain Baseline Regimen. The non-parametric estimate of the difference between groups (Hodges-Lehmann) and its 95% confidence intervals (Moses) are provided.|Null Hypothesis: changes from baseline in the two treatment groups are equal. Alternative Hypothesis: changes from baseline in the two treatment groups are different (two sided).|
1751576|NCT00323427|3218460|Superiority or Other||Mean Difference (Final Values)|-0.004|Standard Error of the Mean|0.15||0.97|2-Sided|95.0|-0.3|0.29||No adjustment|t-test, 2 sided|||H0: mean(Arm 1) = Mean (Arm 2)|
1751577|NCT00323427|3218461|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.14||0.42|2-Sided|95.0|-0.16|0.38||No adjustment.|t-test, 2 sided|||H0: Mean(Arm 1) = Mean(Arm 2)|
1751578|NCT00323427|3218462|Superiority or Other||Mean Difference (Final Values)|0.039|Standard Error of the Mean|0.0974||0.69|2-Sided|95.0|-0.15|0.23||No multiple testing adjustment.|t-test, 2 sided|||H0: Mean(Arm 1) = Mean(Arm 2)|
1751579|NCT00323310|3218473|Superiority or Other||Mean Difference (Final Values)|0.8|Standard Deviation|1.54|<|0.0001|2-Sided|95.0|0.6|1.1||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose|
1751580|NCT00323310|3218474|Superiority or Other||Mean Difference (Final Values)|1.2|Standard Deviation|1.49|<|0.0001|2-Sided|95.0|0.9|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose|
1751581|NCT00323310|3218475|Superiority or Other||Mean Difference (Final Values)|1.2|Standard Deviation|1.57|<|0.0001|2-Sided|95.0|1.0|1.5||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose|
1751582|NCT00323310|3218476|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Deviation|1.2|<|0.0001|2-Sided|95.0|0.4|0.8||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose|
1751583|NCT00323310|3218477|Superiority or Other||Mean Difference (Final Values)|1.1|Standard Deviation|1.49|<|0.001|2-Sided|95.0|0.8|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose|
1751584|NCT00323310|3218478|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Deviation|1.56|<|0.001|2-Sided|95.0|1.1|1.6||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose|
1751585|NCT00323310|3218479|Superiority or Other||Mean Difference (Final Values)|0.7|Standard Deviation|1.42|<|0.0001|2-Sided|95.0|0.4|0.9||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose|
1751586|NCT00323310|3218480|Superiority or Other||Mean Difference (Final Values)|1.2|Standard Deviation|1.45|<|0.0001|2-Sided|95.0|0.9|1.4||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose|
1751587|NCT00323310|3218481|Superiority or Other||Mean Difference (Final Values)|1.3|Standard Deviation|1.46|<|0.0001|2-Sided|95.0|1.1|1.5||H0: udiff = 0; Ha: udiff not = 0|t-test, 2 sided|||Paired t-test to compare change from pre to pre+postdose|
1751588|NCT00323297|3218487|Superiority or Other||Mean Difference (Final Values)|-2.38|Standard Error of the Mean|11.722||0.5802|2-Sided|90.0|-21.843|17.087||A sequential closed-testing procedure was implemented for all secondary endpoints. If no statistically significant treatment effect was found for the primary endpoint then statistical tests were not to be performed on the secondary endpoints.|ANCOVA|The mean difference in method of estimation is the difference between Sildenafil - placebo.||"The estimated sample size was based upon the primary endpoint. A sample size of 51 subjects per treatment group was required to detect a difference of 30 meters between treatments with 80% power at a one‑sided significance level of 0.05, assuming a standard deviation of 60 meters.~This primary statistical analysis was carried for Week 12 data."|
1751589|NCT00323271|3218490|Superiority or Other||Mean Difference (Final Values)|0.644||||0.32|2-Sided|95.0|-1.058|2.345||Multiple imputation used to account for missing variables; pre-treatment rating and years of MS pain were covariates|ANCOVA||||
1751590|NCT00323271|3218491|Superiority or Other||Mean Difference (Final Values)|-0.108||||0.911|2-Sided|95.0|-2.106|1.888|||t-test, 2 sided||||
1751591|NCT00323258|3218493|Non-Inferiority or Equivalence|Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are >/= 75% adherent to statins in the “treatment” arm compared to those who receive “usual care.”||||||0.34|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.|
1751592|NCT00323258|3218494|Non-Inferiority or Equivalence|Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are >/= 75% adherent to beta-blockers in the “treatment” arm compared to those who receive “usual care.”||||||0.03|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.|
1751593|NCT00323258|3218495|Non-Inferiority or Equivalence|Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are >/= 75% adherent to combined beta-blocker and statin therapy in the “treatment” arm compared to those who receive “usual care.”|||||=|0|||||||Chi-squared|||Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.|
1751656|NCT00321984|3218706|Superiority or Other|||||||0.3146||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1752114|NCT00315445|3219623|Superiority or Other||Day 84 Mean|52.5|||||2-Sided|90.0|51.8|58.3|||||||
1751594|NCT00323258|3218496|Non-Inferiority or Equivalence|Equivalence analysis. Null hypothesis: The will be no difference in proportion of participants adherent to triple therapy in the “treatment” arm compared to those who receive “usual care.”||||||0.5|||||||Chi-squared|||Sample size of 286 patients(143 patients per group).Based on an estimated absolute improvement in medication adherence of 15% in the intervention group (eg, 85% in the intervention group, 70% in the control group), a 2-sided test with α level of .05, a 15% dropout rate, and power of 0.80.|
1751595|NCT00323193|3218497|Superiority or Other|||||||0.71|||||||ANOVA||||
1751596|NCT00323193|3218498|Superiority or Other|||||||0.72|||||||ANOVA||||
1751597|NCT00323063|3218515|Other|||||||0.3|||||||Log Rank||||
1751598|NCT00322868|3218526|Superiority or Other|||||||0.75|||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-8|||
1751599|NCT00322868|3218527|Superiority or Other|||||||0.55|||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-6|||
1751600|NCT00322868|3218528|Superiority or Other|||||||0.5|||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum IL-1ß|||
1751601|NCT00322868|3218529|Superiority or Other|||||||0.62|||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum TNFα|||
1751602|NCT00322868|3218530|Superiority or Other|||||||0.5|||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum active elastase|||
1751603|NCT00322868|3218531|Superiority or Other|||||||0.0288|||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in sputum percent neutrophils|||
1751604|NCT00322868|3218532|Superiority or Other|||||||0.2467|||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum neutrophil count|||
1751605|NCT00322868|3218533|Superiority or Other|||||||0.2772|||||||t-test, 1 sided|Paired t-test analysis of the intra-subject change in log10 sputum white cell count|||
1751606|NCT00322621|3218552|Superiority or Other|||||||0.512|||||||t-test, 2 sided||||
1751607|NCT00322621|3218553|Superiority or Other|||||||0.145|||||||t-test, 2 sided||||
1751608|NCT00322621|3218554|Superiority or Other|||||||0.138|||||||t-test, 2 sided||||
1751609|NCT00322621|3218555|Superiority or Other|||||||0.666|||||||t-test, 2 sided||||
1751610|NCT00322621|3218556|Superiority or Other|||||||0.003|||||||t-test, 2 sided||||
1751611|NCT00322621|3218557|Superiority or Other|||||||0.368|||||||t-test, 2 sided||||
1751612|NCT00322621|3218560|Superiority or Other|||||||0.113|||||||t-test, 2 sided||||
1751613|NCT00322621|3218561|Superiority or Other|||||||0.216|||||||t-test, 2 sided||||
1751614|NCT00322621|3218562|Superiority or Other|||||||0.678|||||||t-test, 2 sided||||
1751615|NCT00322621|3218563|Superiority or Other|||||||0.711|||||||t-test, 2 sided||||
1751616|NCT00322621|3218564|Superiority or Other|||||||0.066|||||||t-test, 2 sided||||
1751617|NCT00322621|3218565|Superiority or Other|||||||0.713|||||||t-test, 2 sided||||
1751618|NCT00322621|3218566|Superiority or Other|||||||0.752|||||||t-test, 2 sided||||
1751619|NCT00322621|3218567|Superiority or Other|||||||0.55|||||||t-test, 2 sided||||
1751620|NCT00322621|3218568|Superiority or Other|||||||0.022|||||||t-test, 2 sided||||
1751621|NCT00322621|3218569|Superiority or Other|||||||0.016|||||||t-test, 2 sided||||
1751622|NCT00322621|3218570|Superiority or Other|||||||0.009|||||||t-test, 2 sided||||
1751623|NCT00322621|3218571|Superiority or Other|||||||0.058|||||||t-test, 2 sided||||
1751624|NCT00322621|3218572|Superiority or Other|||||||0.505|||||||t-test, 2 sided||||
1751625|NCT00322621|3218573|Superiority or Other|||||||0.124|||||||t-test, 2 sided||||
1751626|NCT00322621|3218574|Superiority or Other|||||||0.021|||||||t-test, 2 sided||||
1751627|NCT00322621|3218575|Superiority or Other|||||||0.406|||||||t-test, 2 sided||||
1751628|NCT00322621|3218576|Superiority or Other|||||||0.011|||||||t-test, 2 sided||||
1751629|NCT00322621|3218577|Superiority or Other|||||||0.026|||||||t-test, 2 sided||||
1751630|NCT00322621|3218578|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1751631|NCT00322621|3218579|Superiority or Other|||||||0.075|||||||t-test, 2 sided||||
1751632|NCT00322621|3218580|Superiority or Other|||||||0.016|||||||t-test, 2 sided||||
1751633|NCT00322621|3218581|Superiority or Other|||||||0.16|||||||t-test, 2 sided||||
1751634|NCT00322621|3218582|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1751635|NCT00322621|3218583|Superiority or Other|||||||0.269|||||||t-test, 2 sided||||
1751636|NCT00322621|3218586|Non-Inferiority or Equivalence|Non-inferiority margin of 1.5 point on the BPI 24-hour average pain scale.|Mean Difference (Net)|0.35|||<|0.001||97.5|0.35|0.79||Significance level 0.025|t-test, 1 sided|||Null hypothesis is that duloxetine treatment effect on pain reduction in diabetic peripheral neuropathic pain (DPNP) is not maintained, as indicated by an increase of more than 1.5 point on the BPI 24-hour average pain scale. Null hypothesis is rejected at significance level 0.025 if the upper bound of one-sided 97.5% CI is less than or equal to non-inferiority margin of 1.5 point.|
1751637|NCT00322465|3218607|Superiority or Other||Odds Ratio (OR)|0.8||||0.032|2-Sided|95.0|0.66|0.98||A priori threshold for statistical significance was p<0.05.|Regression, Logistic|No other independent variables were included in the model.||The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that the odds ratio is greater than or less than 1.|
1751638|NCT00322465|3218608|Superiority or Other||Odds Ratio (OR)|2.39||||0.074|2-Sided|95.0|0.92|6.22||A priori threshold for statistical signficance was p<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for ever having sex with a prostitute or for money, drugs, or other things(reference category is no) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.|
1751657|NCT00321984|3218706|Superiority or Other||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1751639|NCT00322465|3218608|Superiority or Other||Odds Ratio (OR)|0.2||||0.009|2-Sided|95.0|0.06|0.66||A priori threshold for statistical significance was p<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.|
1751640|NCT00322465|3218609|Superiority or Other||Odds Ratio (OR)|3.92|||<|0.001|2-Sided|95.0|1.93|7.98||A priori threshold for statistical significance was p<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for visit due to sexually transmitted disease contact (reference category is no) is 1 versus the alternative that it is greater than or less than 1.|
1751641|NCT00322465|3218609|Superiority or Other||Odds Ratio (OR)|0.38|||<|0.075|2-Sided|95.0|0.13|1.1||A priori threshold fors tatistical significance was p<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for ever having sex with a prostitute or sex for money, drugs, or other things (reference category is no) is 1 versus the alternative that it is greater than or less than 1.|
1751642|NCT00322465|3218609|Superiority or Other||Odds Ratio (OR)|4.42|||<|0.076|2-Sided|95.0|0.86|22.74||A priori threshold for statistical significance was p<0.05|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 1 or more new sex partners in the last 30 days (reference category is 0) is 1 versus the alternative that it is greater than or less than 1.|
1751643|NCT00322465|3218609|Superiority or Other||Odds Ratio (OR)|1.81|||<|0.051|2-Sided|95.0|1.0|3.3||A priori threshold for statistical significance was p<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for 2 or more sex partners in the last 3 months (reference category is 0-1 partners) is 1 versus the alternative that it is greater than or less than 1.|
1751644|NCT00322465|3218609|Superiority or Other||Odds Ratio (OR)|1.09|||<|0.919|2-Sided|95.0|0.23|5.17||A priori threshold for statistical significance was p<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for large amount of discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multvariable logistic regression model.|
1751645|NCT00322465|3218609|Superiority or Other||Odds Ratio (OR)|2.0|||<|0.164|2-Sided|95.0|0.75|5.33||A priori threshold for statistical significance was p<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for moderate discharge amount (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.|
1751646|NCT00322465|3218609|Superiority or Other||Odds Ratio (OR)|0.87|||<|0.78|2-Sided|95.0|0.33|2.3||A priori threshold for statistical significance was p<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for scant discharge (reference category is no discharge) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.|
1751647|NCT00322465|3218609|Superiority or Other||Odds Ratio (OR)|0.74|||<|0.005|2-Sided|95.0|0.6|0.91||A priori threshold for statistical significance was p<0.05.|Regression, Logistic|Odds ratio has been adjusted for other independent variables included in the model, which are found in the other Statistical Analysis sections.||The null hypothesis is that the odds ratio for age (per 5 years) is 1 versus the alternative that it is greater than or less than 1. This was tested in a multivariable logistic regression model.|
1751648|NCT00322309|3218681|Superiority or Other||Mean Difference (Net)|0.0|Standard Deviation|8.5|>|0.05||95.0|||||t-test, 2 sided|||It was hypothesized that there would not be a significant difference between the two groups in the mean percent of urines positive for riboflavin.|
1751649|NCT00322309|3218682|Superiority or Other||Mean Difference (Net)|0.0|Standard Deviation|18.0|>|0.05||95.0||||Percent of capsules administered does not differ significantly between the two groups.|t-test, 2 sided|||It was hypothesized that there would be no significant difference in the mean percentage of capsules of those dispensed between the two groups.|
1751650|NCT00322309|3218683|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Deviation|5.4|>|0.05|2-Sided|||||This analysis involves a between group comparison.|t-test, 2 sided|||It hypothesized that the two treatment groups would not differ significantly with respect to the total HAM-D scores obtained in the final week of the study (Week 11).|
1751651|NCT00322309|3218684|Superiority or Other||Mean Difference (Final Values)|6.8|Standard Deviation|6.6|>|0.05|2-Sided|95.0|||||t-test, 2 sided|||It was hypothesized that means scores for the CGI-O would not differ significantly for these values obtained in the final treatment week, Week 11.|
1751652|NCT00322309|3218685|Superiority or Other||Mean Difference (Final Values)|1.9|Standard Deviation|2.6|>|0.05|2-Sided|95.0|||||t-test, 2 sided|||It was hypothesized that there would be no significant difference between the two treatment groups for benzoylecgonine data collected for Week 11.|
1751653|NCT00322153|3218689|Superiority or Other||Mean Difference (Final Values)|0.7||||0.177|2-Sided|95.0|-0.3|1.8|||ANCOVA|Least-squares mean (-1.7 in placebo and -1.0 in memantine ER) are controlled for center and adjusted for ADCS-ADL19 baseline value.||The secondary efficacy parameter was change from Baseline at Week 24 in the total score of the 19-Item Alzheimer’s Disease Cooperative Study—Activities of Daily Living Inventory (ADCS-ADL19). Missing scores at week 24 were imputed using the last-observation-carried-forward (LOCF) approach.|
1751654|NCT00322153|3218690|Superiority or Other|||||||0.008|||||||Cochran-Mantel-Haenszel|||The co-primary efficacy parameter was CIBIC-Plus total score at week 24. Missing CIBIC-Plus total scores at Week 24 were imputed using the last-observation-carried-forward (LOCF) approach.|
1751658|NCT00321984|3218706|Superiority or Other||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1751659|NCT00321984|3218708|Superiority or Other|||||||0.72941||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1751660|NCT00321984|3218708|Superiority or Other||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1751661|NCT00321984|3218708|Superiority or Other||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1751662|NCT00321971|3218709|Superiority||Mean Difference (Final Values)|0.421|Standard Error of the Mean|0.11|<|0.05|2-Sided|95.0|0.208|0.657|||Mixed Models Analysis|Intention-to-treat model|The CES-D data were log-transformed for analysis|Hypothesis: The experimental intervention group will endorse lower mean levels of depressive symptoms during follow-up than the study group receiving the comparison intervention.|
1751663|NCT00321919|3218721|Superiority or Other|||||||0.5528|||||||ANCOVA|||Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 2|
1751664|NCT00321919|3218721|Superiority or Other|||||||0.1291|||||||ANCOVA|||Mean Change from Baseline in the Score of Emotional role scale of Quality of life for Year 1|
1751665|NCT00321919|3218721|Superiority or Other|||||||0.7076|||||||ANCOVA|||Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 2|
1751666|NCT00321919|3218721|Superiority or Other|||||||0.3155|||||||ANCOVA|||Mean Change from Baseline in the Score of Bodily pain scale of Quality of life for Year 1|
1751667|NCT00321919|3218721|Superiority or Other|||||||0.0123|||||||ANCOVA|||Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 2|
1751668|NCT00321919|3218721|Superiority or Other|||||||0.0009|||||||ANCOVA|||Mean Change from Baseline in the Score of Vitality function scale of Quality of life for Year 1|
1751669|NCT00321919|3218721|Superiority or Other|||||||0.1455|||||||ANCOVA|||Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 2|
1751670|NCT00321919|3218721|Superiority or Other|||||||0.0058|||||||ANCOVA|||Mean Change from Baseline in the Score of Social function scale of Quality of life for Year 1|
1751671|NCT00321919|3218721|Superiority or Other|||||||0.167|||||||ANCOVA|||Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 2|
1751672|NCT00321919|3218721|Superiority or Other|||||||0.0097|||||||ANCOVA|||Mean Change from Baseline in the Score of Physical Role scale of Quality of life for Year 1|
1751673|NCT00321919|3218721|Superiority or Other|||||||0.9864|||||||ANCOVA|||Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 2|
1751674|NCT00321919|3218721|Superiority or Other|||||||0.0004|||||||ANCOVA|||Mean Change from Baseline in the Score of Physical function scale of Quality of life for Year 1|
1751675|NCT00321919|3218721|Superiority or Other|||||||0.0965|||||||ANCOVA|||Mean Change from Baseline in the Score of Mental Health scale of Quality of life for Year 2|
1751676|NCT00321919|3218721|Superiority or Other|||||||0.0005|||||||ANCOVA|||Mean Change from Baseline in the Score of Mental health scale of Quality of life for Year 1|
1751677|NCT00321919|3218721|Superiority or Other|||||||0.0081|||||||ANCOVA|||Mean Change from Baseline in the Score of General health scale of Quality of life for Year 2|
1751678|NCT00321919|3218721|Superiority or Other|||||||0.0029|||||||ANCOVA|||Mean Change from Baseline in the Score of General health scale of Quality of life for Year 1.|
1751679|NCT00321919|3218728|Superiority or Other||Risk Ratio (RR)|0.82046||||0.3419|2-Sided|95.0|0.55|1.23|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to first hospitalization for cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.||
1751680|NCT00321919|3218730|Superiority or Other||Risk Ratio (RR)|0.804594||||0.4985|2-Sided|95.0|0.43|1.51|||Regression, Cox||The Cox regression model was used to estimate the relative risk of time to first cardiovascular intervention in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group||
1751681|NCT00321919|3218733|Superiority or Other||Risk Ratio (RR)|0.658259||||0.1391|2-Sided|95.0|0.38|1.15|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to death for all causes in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy treatment group.||
1751682|NCT00321919|3218735|Superiority or Other||Risk Ratio (RR)|0.744575||||0.4833|2-Sided|95.0|0.33|1.7|||Regression, Cox||The Cox regression model was used to estimate the relative risk of an event of the time to death due to cardiovascular reasons in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.||
1751683|NCT00321919|3218736|Superiority or Other||Risk Ratio (RR)|0.778976||||0.2036|2-Sided|95.0|0.53|1.14|||Regression, Cox||The Cox regression model was used to estimate the relative risk of the time to first cardiovascular event in Late Epoetin beta therapy group compared to the Early Epoetin beta therapy group.|The null hypothesis stated that there was no difference with regard to the event-free distribution of the combined endpoint of all protocol specified cardiovascular events between Early Epoetin beta therapy and Late Epoetin beta therapy groups.|
1751684|NCT00321854|3218753|Superiority or Other||Mean Difference (Net)|-0.5|Standard Error of the Mean|2.5||0.8397||95.0|-5.4|4.4|||ANCOVA||||
1751685|NCT00321854|3218769|Superiority or Other||Median Difference (Net)|3.0||||0.0282||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)||||
1751686|NCT00321854|3218770|Superiority or Other||Median Difference (Net)|2.0||||0.0489||95.0|0.0|5.0|||Wilcoxon (Mann-Whitney)||||
1751687|NCT00321854|3218771|Superiority or Other||Median Difference (Net)|0.051|||<|0.0001||95.0|0.0|0.089|||Wilcoxon (Mann-Whitney)||||
1751688|NCT00321854|3218772|Superiority or Other||Median Difference (Net)|0.0||||0.2605||95.0|0.0|0.026|||Wilcoxon (Mann-Whitney)||||
1751689|NCT00321854|3218773|Superiority or Other||Median Difference (Net)|-2.031||||0.0001||95.0|-3.125|-0.938|||Wilcoxon (Mann-Whitney)||||
1751690|NCT00321854|3218774|Superiority or Other||Median Difference (Net)|-0.573||||0.2149||95.0|-1.823|0.677|||Wilcoxon (Mann-Whitney)||||
1751691|NCT00321854|3218775|Superiority or Other||Mean Difference (Net)|-0.7|Standard Error of the Mean|0.3||0.0422||95.0|-1.4|0.0|||ANCOVA||||
1751692|NCT00321854|3218776|Superiority or Other||Mean Difference (Net)|-1.4|Standard Error of the Mean|0.4||0.0005||95.0|-2.1|-0.6|||ANCOVA||||
1751693|NCT00321854|3218777|Superiority or Other||Mean Difference (Net)|-1.4|Standard Error of the Mean|0.4||0.0009||95.0|-2.2|-0.6|||ANCOVA||||
1751694|NCT00321854|3218778|Superiority or Other||Mean Difference (Net)|-0.5|Standard Error of the Mean|0.4||0.1702||95.0|-1.3|0.2|||ANCOVA||||
1751695|NCT00321854|3218779|Superiority or Other||Odds Ratio (OR)|1.153||||0.7913||95.0|0.403|3.299|||Regression, Logistic|||The ordinal responses (3 levels) were analysed using the proportional odds model extension of logistic regression|
1751696|NCT00321854|3218780|Superiority or Other||Odds Ratio (OR)|0.796||||0.5116||95.0|0.403|1.573|||Regression, Logistic||||
1751697|NCT00321854|3218781|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.1||0.4381||95.0|-0.3|0.1|||ANCOVA||||
1751698|NCT00321854|3218782|Superiority or Other||Mean Difference (Net)|-0.4|Standard Error of the Mean|0.1||0.0007||95.0|-0.6|-0.2|||ANCOVA||||
1751699|NCT00321854|3218783|Superiority or Other||Mean Difference (Net)|-0.3|Standard Error of the Mean|0.1||0.0173||95.0|-0.5|-0.1|||ANCOVA||||
1751700|NCT00321854|3218784|Superiority or Other||Mean Difference (Net)|-0.2|Standard Error of the Mean|0.1||0.1607||95.0|-0.4|0.1|||ANCOVA||||
1751701|NCT00321854|3218785|Superiority or Other||Mean Difference (Net)|-0.3|Standard Error of the Mean|0.1||0.0376||95.0|-0.5|0.0|||ANCOVA||||
1751702|NCT00321854|3218786|Superiority or Other||Mean Difference (Net)|-1.0|Standard Error of the Mean|0.2|<|0.0001||95.0|-1.5|-0.6|||ANCOVA||||
1751703|NCT00321854|3218787|Superiority or Other||Mean Difference (Net)|-1.1|Standard Error of the Mean|0.3|<|0.0001||95.0|-1.6|-0.6|||ANCOVA||||
1751704|NCT00321854|3218788|Superiority or Other||Mean Difference (Net)|-1.1|Standard Error of the Mean|0.3||0.0001||95.0|-1.7|-0.5|||ANCOVA||||
1751705|NCT00321854|3218789|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.3||0.9792||95.0|-0.6|0.6|||ANCOVA||||
1751706|NCT00321854|3218790|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.3||0.9256||95.0|-0.6|0.6|||ANCOVA||||
1751707|NCT00321854|3218791|Superiority or Other||Mean Difference (Net)|-1.8|Standard Error of the Mean|0.5||0.0002||95.0|-2.7|-0.9|||ANCOVA||||
1751708|NCT00321854|3218792|Superiority or Other||Mean Difference (Net)|-2.9|Standard Error of the Mean|0.6|<|0.0001||95.0|-4.0|-1.8|||ANCOVA||||
1751709|NCT00321854|3218793|Superiority or Other||Mean Difference (Net)|-3.3|Standard Error of the Mean|0.6|<|0.0001||95.0|-4.5|-2.2|||ANCOVA||||
1751710|NCT00321854|3218794|Superiority or Other||Mean Difference (Net)|0.2|Standard Error of the Mean|0.7||0.7395||95.0|-1.1|1.5|||ANCOVA||||
1751711|NCT00321854|3218795|Superiority or Other||Mean Difference (Net)|-0.2|Standard Error of the Mean|0.7||0.7999||95.0|-1.5|1.1|||ANCOVA||||
1751712|NCT00321854|3218796|Superiority or Other||Mean Difference (Net)|-2.8|Standard Error of the Mean|0.6|<|0.0001||95.0|-3.9|-1.7|||ANCOVA||||
1751713|NCT00321854|3218797|Superiority or Other||Mean Difference (Net)|-4.0|Standard Error of the Mean|0.7|<|0.0001||95.0|-5.4|-2.6|||ANCOVA||||
1751714|NCT00321854|3218798|Superiority or Other||Mean Difference (Net)|-4.5|Standard Error of the Mean|0.8|<|0.0001||95.0|-6.0|-3.0|||ANCOVA||||
1751715|NCT00321854|3218799|Superiority or Other||Mean Difference (Net)|0.2|Standard Error of the Mean|0.9||0.8155||95.0|-1.5|1.9|||ANCOVA||||
1751716|NCT00321854|3218800|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.9||0.8693||95.0|-1.8|1.5|||ANCOVA||||
1751717|NCT00321854|3218801|Superiority or Other||Mean Difference (Net)|-2.9|Standard Error of the Mean|0.6|<|0.0001||95.0|-4.1|-1.7|||ANCOVA||||
1751718|NCT00321854|3218802|Superiority or Other||Mean Difference (Net)|-4.4|Standard Error of the Mean|0.7|<|0.0001||95.0|-5.8|-3.0|||ANCOVA||||
1751719|NCT00321854|3218803|Superiority or Other||Mean Difference (Net)|-4.8|Standard Error of the Mean|0.8|<|0.0001||95.0|-6.3|-3.2|||ANCOVA||||
1751720|NCT00321854|3218804|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.9||0.9568||95.0|-1.7|1.8|||ANCOVA||||
1751721|NCT00321854|3218805|Superiority or Other||Mean Difference (Net)|-0.4|Standard Error of the Mean|0.9||0.6503||95.0|-2.2|1.4|||ANCOVA||||
1751722|NCT00321789|3218814|Superiority or Other||Odds Ratio (OR)|0.95||||0.87|2-Sided|95.0|0.6|1.7|||Regression, Logistic|Model adjusted for a priori race and cardiovascular disease risk category.|||
1751723|NCT00321789|3218815|Superiority or Other||Mean Difference (Net)|-0.64||||0.09|2-Sided|95.0|-1.38|0.1|||Mixed Models Analysis|Model adjusted for a priori race and cardiovascular disease risk category.|||
1751724|NCT00321789|3218816|Superiority or Other||Mean Difference (Net)|-2.11||||0.04|2-Sided|95.0|-4.13|-0.09|||Mixed Models Analysis|Model adjusted for a priori race and cardiovascular disease risk category.|||
1751725|NCT00321789|3218817|Superiority or Other||incident rate ratio|1.1||||0.37|2-Sided|95.0|0.9|1.4|||generalized estimating equations|Model adjusted for a priori race and cardiovascular disease risk category.|||
1751726|NCT00321789|3218818|Superiority or Other||incident rate ratio|1.2||||0.06|2-Sided|95.0|1.0|1.5|||generalized estimating equations|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.|||
1751727|NCT00321789|3218819|Superiority or Other||Mean Difference (Net)|0.07||||0.26|2-Sided|95.0|-0.06|0.2|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.|||
1751728|NCT00321789|3218820|Superiority or Other||Mean Difference (Net)|-0.13||||0.11|2-Sided|95.0|-0.3|0.03|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.|||
1751819|NCT00320489|3218968|Superiority or Other|||||||0.581||||||P-value is for change from baseline to Week 104.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751729|NCT00321789|3218821|Superiority or Other||Mean Difference (Net)|-0.16||||0.02|2-Sided|95.0|-0.29|-0.03|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.|||
1751730|NCT00321789|3218822|Superiority or Other||Mean Difference (Net)|-0.16||||0.02|2-Sided|95.0|-0.29|-0.02|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.|||
1751731|NCT00321789|3218823|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.03|2-Sided|95.0|-0.23|-0.01|||Mixed Models Analysis|Based on log-transformed values. Model was adjusted for a priori race and cardiovascular disease risk level strata.|||
1751732|NCT00321789|3218824|Superiority or Other||Mean Difference (Final Values)|2.3||||0.44|2-Sided|95.0|-3.6|8.3|||Mixed Models Analysis|Model was adjusted for a priori race and cardiovascular disease risk level strata.|||
1751733|NCT00321737|3218836|Superiority or Other|||||||0.11257||||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1751734|NCT00321737|3218836|Superiority or Other||||||<|1e-05||||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dose to placebo.|Wilcoxon (Mann-Whitney)||||
1751735|NCT00321737|3218836|Superiority or Other||||||<|1e-05||||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dose to placebo.|Wilcoxon (Mann-Whitney)||||
1751736|NCT00321737|3218837|Superiority or Other|||||||0.13932||||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Log Rank||||
1751737|NCT00321737|3218837|Superiority or Other||||||<|1e-05||||||Hochberg’s method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank||||
1751738|NCT00321737|3218837|Superiority or Other||||||<|1e-05||||||Hochberg’s method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank||||
1751739|NCT00321737|3218839|Superiority or Other|||||||0.0673||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1751740|NCT00321737|3218839|Superiority or Other||||||<|1e-05||||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)||||
1751741|NCT00321737|3218839|Superiority or Other||||||<|1e-05||||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparison of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)||||
1751742|NCT00321737|3218840|Superiority or Other||||||>|0.99999||||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Fisher Exact||||
1751743|NCT00321737|3218840|Superiority or Other||||||<|1e-05||||||Hochberg’s method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact||||
1751744|NCT00321737|3218840|Superiority or Other||||||<|1e-05||||||Hochberg’s method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact||||
1751745|NCT00321711|3218841|Superiority or Other||Odds Ratio (OR)|0.211||||||95.0|0.021|2.082|||||||
1751746|NCT00321711|3218841|Superiority or Other||Odds Ratio (OR)|0.315||||||95.0|0.029|3.412|||||||
1751747|NCT00321711|3218841|Superiority or Other||Difference in incidence rate|-33.5||||||95.0|-69.0|2.0|||||Romiplostim - placebo||
1751748|NCT00321711|3218842|Superiority or Other||Odds Ratio (OR)|0.444||||||95.0|0.032|6.08|||||Romiplostim/placebo||
1751749|NCT00321711|3218842|Superiority or Other||Odds Ratio (OR)|0.445||||||95.0|0.037|5.325|||||Romiplostim/placebo||
1751750|NCT00321711|3218842|Superiority or Other||Odds Ratio (OR)|1.827||||||95.0|0.347|9.618|||||Romiplostim/placebo||
1751751|NCT00321711|3218843|Superiority or Other||Odds Ratio (OR)|1.0||||||95.0|0.063|15.988|||||Romiplostim/placebo||
1751752|NCT00321711|3218844|Superiority or Other||Odds Ratio (OR)|0.118||||||95.0|0.007|1.882|||||Adjusted by the stratification factor||
1751753|NCT00321711|3218844|Superiority or Other||Odds Ratio (OR)|0.333||||||95.0|0.028|3.926|||||||
1751754|NCT00321711|3218844|Superiority or Other||Odds Ratio (OR)|1.032||||||95.0|0.153|6.95|||||||
1751755|NCT00321672|3218858|Superiority or Other|||||||0.0553||||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.|||
1751756|NCT00321672|3218858|Superiority or Other|||||||0.5582||||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.|||
1751757|NCT00321672|3218858|Superiority or Other|||||||0.0662||||||All statistical tests of hypotheses were two-sided and at the 5% level of significance.|Regression, Logistic|A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.||"The null hypothesis was: There is no difference between the total Control and total NGX-4010 group in the Proportion of Subjects Reaching 30% Decrease in Their Mean Average Pain for the Past 24 Hours NPRS Score From Baseline During Weeks 2 to 12."|
1751758|NCT00321672|3218859|Superiority or Other|||||||0.0896||||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.|||
1751759|NCT00321672|3218859|Superiority or Other|||||||0.468||||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.|||
1751820|NCT00320489|3218969|Superiority or Other|||||||0.465||||||P-value is for change from baseline to Week 104.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1752115|NCT00315445|3219623|Superiority or Other||Day 84 Mean|52.4||||||90.0|50.3|56.6|||||||
1751760|NCT00321672|3218859|Superiority or Other|||||||0.0831||||||All statistical tests of hypotheses were two-sided and at the 5% level of significance.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||"The null hypothesis was: There is no difference between the total Control and total NGX-4010 in the absolute change in NPRS scores from Baseline during Weeks 2-12."|
1751761|NCT00321672|3218860|Superiority or Other|||||||0.1031||||||All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.|||
1751762|NCT00321672|3218860|Superiority or Other|||||||0.4884||||||All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.|||
1751763|NCT00321672|3218860|Superiority or Other|||||||0.0967||||||All stastical tests of hypotheses were two-sided and at the 5% level of significance.|ANCOVA|Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.||The null hypothesis was that there was no difference between the average percent change in NPRS scores from baseline to weeks 2-12 between the total control and total NGX-4010 groups. The ratio of means between the 30- and 60-minute control group [1.57 (90% CI: 1.12–2.35)] was > than the pre-specified equivalence margin ratio of 80–125%. Hence, the control groups could not be pooled and comparisons were performed between the 30- and 60-minute NGX-4010 groups and their respective control groups.|
1751764|NCT00321620|3218863|Superiority or Other||Rate ratio|0.82||||0.0085||95.0|0.71|0.94|||Anderson-Gill model|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).||
1751765|NCT00321620|3218864|Superiority or Other||Hazard Ratio (HR)|0.82||||0.0085||95.0|0.71|0.95|||Regression, Cox|P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure.|Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy).||
1751766|NCT00321620|3218865|Non-Inferiority or Equivalence|A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves as least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.82||||0.0002||95.0|0.71|0.95|||Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prostate-specific antigen level, and current chemotherapy)||
1751767|NCT00321594|3218867|Other||Maximum Tolerated Dose|1400.0|||||2-Sided||||||||MTD was not reached and the maximum dose of 1400 mg/m2 is used in Phase II portion|MTD is defined as the dose below which >=2 of 3 or >= 2 of 6 patients experience DLT|
1751768|NCT00321464|3218871|Superiority or Other||Rate ratio|0.77||||0.001||95.0|0.66|0.89||P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure|Anderson-Gill model||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).||
1751769|NCT00321464|3218872|Superiority or Other||Hazard Ratio (HR)|0.82||||0.01||95.0|0.71|0.95||P-value was adjusted for multiplicity according to a hierarchical testing strategy and Hochberg procedure|Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).||
1751770|NCT00321464|3218873|Non-Inferiority or Equivalence|A synthesis method was used for the non-inferiority test for the hypothesis that denosumab preserves at least 50% of the effect of zoledronic acid vs. placebo.|Hazard Ratio (HR)|0.82|||<|0.0001||95.0|0.71|0.95|||Regression, Cox||Stratified by the randomization stratification factors (previous skeletal-related event, prior oral bisphosphonate use, current chemotherapy, and location in Japan).||
1751771|NCT00321269|3218881|Superiority or Other|||||||0.13|||||||Mixed Models Analysis|F(2,110)=2.08; P=0.13|||
1751772|NCT00321269|3218882|Superiority or Other|||||||0.9|||||||Mixed Models Analysis|||Mixed effects regression analysis- Treatment Arm X Time F (2, 116)=0.09, P>F=0.90.|
1751773|NCT00320671|3218902|Non-Inferiority or Equivalence|Equivalence Analysis|Cumulative Response Rates|62.8||||0.61|2-Sided|95.0|50.8|74.8|||Log Rank||Only subjects taking aripiprazole were analysed in this section||
1751774|NCT00320671|3218902|Non-Inferiority or Equivalence|Equivalence Analysis|Cumulative Response Rates|56.8||||0.61|2-Sided|95.0|43.9|69.9|||Log Rank||Only the subjects taking risperidone were analysed in this section||
1751775|NCT00320606|3218912|Other||Binomial Proportion|0.0|||||2-Sided|95.0|0.0|0.1684|||||95% Confidence Interval Exact Binomial|The proportion of participants in whom immunosuppression (IS) withdrawal was attempted who are successfully withdrawn from immunosuppression and experience death or graft loss are descriptively summarized with 95% confidence intervals using an exact binomial method.|
1751776|NCT00320606|3218913|Other||95% confidence interval using an exact b|0.6|||||2-Sided|95.0|0.4|0.8|||||Proportion Success|The proportion of participants in whom immunosuppression withdrawal was attempted who are successfully withdrawn from immunosuppression are descriptively summarized with 95% confidence intervals using an exact binomial method|
1751777|NCT00320593|3218915|Superiority or Other||Mean Difference (Net)|0.23|||||2-Sided|95.0|0.02|0.45||||||A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 2 years, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 2 years, in which myopia at 2 years was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 2 year values were known) were included.|
1751778|NCT00320593|3218916|Superiority or Other||Mean Difference (Net)|0.14|||||2-Sided|95.0|-0.005|0.28||||||A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 1 year, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 1 year, in which myopia at 1 year was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 1 year values were known) were included.|
1752116|NCT00315445|3219624|Superiority or Other||Day 84 Mean|41.9|||||2-Sided|90.0|32.1|42.5|||||||
1751779|NCT00320593|3218919|Superiority or Other||Mean Difference (Net)|0.27|||||2-Sided|95.0|0.02|0.53||||||An adjusted analysis for the treatment group difference of change in spherical equivalent from baseline to 3 years was performed by including in an analysis of covariance (ANCOVA) model the following covariates in addition to baseline myopia and prior single vision lens wear, which are known to be related to myopia progression: age, sex, ethnicity, accommodative lag, and magnitude of near esophoria.|
1751780|NCT00320593|3218919|Superiority or Other||Mean Difference (Net)|0.28|||||2-Sided|95.0|0.01|0.55||||||The primary analysis was a comparison of treatment groups using an analysis of covariance (ANCOVA) model in which myopia at 3 years was adjusted for myopia at baseline and prior SVL wear. The sample size was computed to reach a 90% power and type I error rate of 5%, so that a difference in 3-year myopia progression between treatment groups would be detected if the true difference was at least 0.60 D, assuming a standard deviation of 0.85 D in each group and loss of follow up of 10%.|
1751781|NCT00320541|3218923|Superiority or Other|||||||0.036|||||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.|||
1751782|NCT00320541|3218924|Superiority or Other|||||||0.067|||||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.|||
1751783|NCT00320541|3218925|Superiority or Other|||||||0.004|||||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.|||
1751784|NCT00320541|3218926|Superiority or Other|||||||0.002|||||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.|||
1751785|NCT00320541|3218927|Superiority or Other|||||||0.023|||||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.|||
1751786|NCT00320541|3218928|Superiority or Other|||||||0.119|||||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.|||
1751787|NCT00320541|3218929|Superiority or Other|||||||0.01|||||||ANCOVA|ANCOVA model included treatment arm and baseline assessment.|||
1751788|NCT00320541|3218930|Superiority or Other|||||||0.475|||||||Log Rank||||
1751789|NCT00320541|3218931|Superiority or Other|||||||0.247|||||||Log Rank||||
1751790|NCT00320541|3218932|Superiority or Other|||||||0.117||||||Statistical significance at 0.05 level was required.|Fisher Exact|||Assuming the response rate for the PB arm is 34% and the addition of gemcitabine will improve it to 54%, then a sample size of 170 evaluable participants (85 per arm) will give an 80% statistical power to detect the difference, using a 1-sided test at the significance level of 0.05. Confidence levels are exact binomial 95% Confidence Intervals.|
1751791|NCT00320489|3218947|Superiority or Other|||||||0.885|||||||Fisher Exact||||
1751792|NCT00320489|3218948|Superiority or Other|||||||0.247||||||P-value is for total bilirubin.|Fisher Exact||||
1751793|NCT00320489|3218948|Superiority or Other|||||||0.723||||||P-value is for AST.|Fisher Exact||||
1751794|NCT00320489|3218948|Superiority or Other|||||||0.834||||||P-value is for ALT.|Fisher Exact||||
1751795|NCT00320489|3218949|Superiority or Other|||||||0.835|||||||Fisher Exact||||
1751796|NCT00320489|3218950|Superiority or Other|||||||0.908||||||P-value is for fasting triglycerides.|Fisher Exact||||
1751797|NCT00320489|3218950|Superiority or Other|||||||0.688||||||P-value is for fasting total cholesterol.|Fisher Exact||||
1751798|NCT00320489|3218950|Superiority or Other|||||||0.258||||||P-value for fasting glucose.|Fisher Exact||||
1751799|NCT00320489|3218951|Superiority or Other|||||||0.53|||||||Fisher Exact||||
1751800|NCT00320489|3218952|Superiority or Other|||||||0.777||||||P-value is for change from baseline to Week 104.|ANCOVA|Model: change = baseline, treatment, and investigator.|||
1751801|NCT00320489|3218954|Superiority or Other|||||||0.952|||||||ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy*Visit Baseline.|||
1751802|NCT00320489|3218955|Superiority or Other|||||||0.659|||||||Fisher Exact||||
1751803|NCT00320489|3218956|Superiority or Other|||||||0.585|||||||Log Rank||||
1751804|NCT00320489|3218957|Superiority or Other|||||||0.893||||||P-value is for PANSS General Psychopathology Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751805|NCT00320489|3218957|Superiority or Other|||||||0.692||||||P-value is for PANSS Negative Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751806|NCT00320489|3218957|Superiority or Other|||||||0.871||||||P-value is for PANSS Positive Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy*Visit Baseline.|||
1751807|NCT00320489|3218957|Superiority or Other|||||||0.834||||||P-value is for PANSS Total Score.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy*Visit Baseline.|||
1751808|NCT00320489|3218958|Superiority or Other|||||||0.282|||||||ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy*Visit Baseline.|||
1751809|NCT00320489|3218959|Superiority or Other|||||||0.6|||||||Fisher Exact||||
1751810|NCT00320489|3218960|Superiority or Other|||||||0.854|||||||ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy*Visit.|||
1751811|NCT00320489|3218961|Superiority or Other|||||||0.492||||||P-value is for side effects - current vs previous medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy*Visit.|||
1751812|NCT00320489|3218961|Superiority or Other|||||||0.258||||||P-value is for preference current/previous medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy*Visit|||
1751813|NCT00320489|3218961|Superiority or Other|||||||0.6||||||P-value is for overall satisfaction with current medication.|ANCOVA|Model: Actual Result = Therapy, Investigator, Visit, Therapy*Visit.|||
1751814|NCT00320489|3218962|Superiority or Other|||||||0.681||||||P-value is fro change from baseline to Week 104.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751815|NCT00320489|3218963|Superiority or Other|||||||0.371||||||P-value is for change from baseline to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.|||
1751816|NCT00320489|3218964|Superiority or Other|||||||0.747||||||P-value is for Total Score (Items 1-4) change to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.|||
1751817|NCT00320489|3218964|Superiority or Other|||||||0.583||||||P-value is for Total Score (Items 1-5) change to Week 104.|ANCOVA|Model: change = investigator, treatment, and baseline.|||
1751818|NCT00320489|3218965|Superiority or Other|||||||0.02|||||||ANOVA|P-value is type III p-value of ANOVA model: Total number of hospitalization days = Therapy.|||
1751821|NCT00320489|3218970|Superiority or Other|||||||0.781||||||P-value for change at Week 104 in Mental Health.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751822|NCT00320489|3218970|Superiority or Other|||||||0.775||||||P-value for change at Week 104 in Role-Emotional.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751823|NCT00320489|3218970|Superiority or Other|||||||0.256||||||P-value for change at Week 104 in Social Functioning.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751824|NCT00320489|3218970|Superiority or Other|||||||0.594||||||P-value for change at Week 104 in Vitality.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751825|NCT00320489|3218970|Superiority or Other|||||||0.229||||||P-value for change at Week 104 in General Health.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751826|NCT00320489|3218970|Superiority or Other|||||||0.135||||||P-value for change at Week 104 in Bodily Pain.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751827|NCT00320489|3218970|Superiority or Other|||||||0.454||||||P-value for change at Week 104 in Role-Physical.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751828|NCT00320489|3218970|Superiority or Other|||||||0.64||||||P-value for change at Week 104 in Physical Functioning.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751829|NCT00320489|3218970|Superiority or Other|||||||0.653||||||P-value for change at Week 104 in Physical Score Detail.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751830|NCT00320489|3218970|Superiority or Other|||||||0.744||||||P-value for change at Week 104 in Mental Score Detail.|ANCOVA|Change = Therapy, Investigator, Visit, Therapy*Visit, Baseline.|||
1751831|NCT00320489|3218971|Superiority or Other|||||||0.649||||||P-Value is for change from baseline at Week 104.|ANCOVA|Model: Change = Therapy, Investigator, Visit, Therapy*Visit Baseline.|||
1751832|NCT00320489|3218972|Superiority or Other|||||||0.612|||||||Log Rank||||
1751833|NCT00320411|3218995|Superiority or Other||percentage of participants|22.8||||||95.0|11.6|34.0|||||||
1751834|NCT00320411|3218996|Superiority or Other||percentage of participants|32.3||||||95.0|20.0|44.7|||||||
1751835|NCT00320411|3218998|Superiority or Other||percentage of participants|17.2||||||95.0|8.6|29.4|||||||
1751836|NCT00320385|3219017|Superiority or Other||Odds Ratio (OR)|2.2||||0.01|2-Sided|95.0|1.2|4.5|||Fisher Exact||Clinical Benefit was compared between treatment arms using stratified Fisher's exact tests.||
1751837|NCT00320385|3219018|Superiority or Other||Odds Ratio (OR)|1.5||||0.46|2-Sided|95.0|0.6|3.9|||Fisher Exact||Responses were compared between treatment arms using stratified Fisher's exact tests.||
1751838|NCT00320385|3219019|Superiority or Other||Hazard Ratio (HR)|0.75||||0.106|2-Sided|95.0|0.53|1.07|||Log Rank||The Pike estimator of the treatment hazard ratio based on the log-rank test was provided, together with a 95% confidence interval.||
1751839|NCT00320385|3219020|Superiority or Other||Hazard Ratio (HR)|0.73||||0.008|2-Sided|95.0|0.57|0.93|||Log Rank||The Pike estimator of the treatment hazard ratio based on the log-rank test was provided, together with a 95% confidence interval.||
1751840|NCT00320372|3219021|Superiority or Other||Pearson Correlation Coefficients|0.04625||||0.0012|2-Sided|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline primary diagnosis of MDE.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline primary diagnosis of MDE."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.|
1751841|NCT00320372|3219022|Superiority or Other||Pearson Correlation Coefficients|0.14819|||<|0.0001|2-Sided|||||"Null hypothesis: There is a correlation between MADRS f/u suicidal thoughts and baseline intent of suicidal gesture.~Alternate hypothesis: There is no correlation between MADRS f/u suicidal thoughts and baseline intent of suicidal gesture."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.|
1751842|NCT00320372|3219023|Superiority or Other||Pearson Correlation Coefficients|0.14837|||<|0.0001|2-Sided|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline medical threat to life.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline medical threat to life."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.|
1751843|NCT00320372|3219024|Superiority or Other||||||<|0.0001|||||||ANCOVA|||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|
1751844|NCT00320372|3219024|Superiority or Other||MMRM Least Squares Mean|7.5964|||<||2-Sided|95.0|6.1327|9.0602|||||Mixed Model Repeated Measure analysis on Q-LES-Q change from baseline score (continuous var) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|
1751893|NCT00319501|3219139|Superiority or Other|||||||0.245||||||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Fisher Exact||||
1751894|NCT00319501|3219140|Superiority or Other|||||||0.443|||||||Fisher Exact||||
1751845|NCT00320372|3219024|Superiority or Other||MMRM Least Squares Mean|12.1009|||<||2-Sided|95.0|10.8979|13.3039|||||Mixed Model Repeated Measure analysis on Q-LES-Q change from baseline score (continuous var) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|
1751846|NCT00320372|3219024|Superiority or Other||||||<|0.0009||||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||60 Month Time point|
1751847|NCT00320372|3219024|Superiority or Other||||||<|0.0048||||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||54 Month Time point|
1751848|NCT00320372|3219024|Superiority or Other||||||<|0.0363||||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||48 Month Time point|
1751849|NCT00320372|3219024|Superiority or Other||||||<|0.0051||||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||42 Month Time point|
1751850|NCT00320372|3219024|Superiority or Other||||||<|0.0002||||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||36 Month Time point|
1751851|NCT00320372|3219024|Superiority or Other||||||<|0.0028||||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||30 Month Time point|
1751852|NCT00320372|3219024|Superiority or Other||||||<|0.0059||||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||24 Month Time point|
1751853|NCT00320372|3219024|Superiority or Other||||||<|0.0001||||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||18 Month Time point|
1751854|NCT00320372|3219024|Superiority or Other||||||<|0.0003||||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||12 Month Time point|
1751855|NCT00320372|3219024|Superiority or Other||||||<|0.0008||||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||9 Month Time point|
1751856|NCT00320372|3219024|Superiority or Other||||||<|0.0068||||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||6 Month Time point|
1751857|NCT00320372|3219024|Superiority or Other||||||<|0.0001||||||"Null Hypothesis: Difference between change from baseline value of two treatment groups equals zero.~Alternate Hypothesis: Difference between change from baseline value of two treatment groups is not equal to zero."|F-Test|||3 Month Time point|
1751858|NCT00320372|3219025|Superiority or Other||Pearson Correlation Coefficients|0.34997|||<|0.0001|2-Sided|||||"Null hypothesis: There is a correlation between MADRS follow-up suicidal thoughts and baseline suicidal thoughts.~Alternate hypothesis: There is no correlation between MADRS follow-up suicidal thoughts and baseline suicidal thoughts."|Pearson Correlation Coefficients|||The statistical modeling of predictors of suicide attempts and suicidal ideations considered 15 variables, defined in the protocol a priori to determine which ones were predictive of suicide attempts and suicidal ideations. Four variables representing the baseline disease and patient factors were considered predictors of suicidality. This outcome measure presents the underlying data collected and the corresponding correlation coefficient for one of the 4 variables identified.|
1751859|NCT00320372|3219031|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.|
1751860|NCT00320372|3219031|Superiority or Other||MMRM Least Squares Mean|8.1|||<||2-Sided|95.0|6.9|9.5|||||Mixed Model Repeated Measure analysis on MADRS remitters (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of remitters across groups is the same. Alternate Hypothesis: Percentage of remitters across groups is different.|
1751861|NCT00320372|3219031|Superiority or Other||MMRM Least Squares Mean|19.8|||<||2-Sided|95.0|18.4|21.3|||||Mixed Model Repeated Measure analysis on MADRS remitters (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of remitters across groups is the same. Alternate Hypothesis: Percentage of remitters across groups is different.|
1751862|NCT00320372|3219032|Superiority or Other|||||||0.1015||||||Comparison for Kaplan Meier Median Time until recurrence|Log Rank|Null hypothesis: median TUR between 2 groups is not different. Alternate hypothesis: median TUR between 2 groups is different.|||
1751863|NCT00320372|3219033|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.|
1751864|NCT00320372|3219033|Superiority or Other||MMRM Least Squares Mean|17.0|||<||2-Sided|95.0|15.2|19.0|||||Mixed Model Repeated Measure analysis on MADRS responders (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.|
1751865|NCT00320372|3219033|Superiority or Other||MMRM Least Squares Mean|38.1|||<||2-Sided|95.0|36.3|39.9|||||Mixed Model Repeated Measure analysis on MADRS responders (binary variable with 1=yes, 0=no) as the response variable in the model. The covariates are treatment, visit and propensity quintile. This analysis of covariance produced least square means.|Null Hypothesis: Percentage of responders across groups is the same. Alternate Hypothesis: Percentage of responders across groups is different.|
1751866|NCT00320281|3219042|Superiority or Other|||||||0.432|||||||ANCOVA||||
1751867|NCT00320242|3219055|Other|The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0||||||0.002||||||Two-tailed one-sample t-test with a hypothesized mean of 0. This analysis was not adjusted for multiple comparisons.|t-test, 2 sided|||The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0|
1751868|NCT00320242|3219056|Superiority||Mean Difference (Net)|1.11|Standard Deviation|1.31||0.02|2-Sided||||||Wilcoxon (Mann-Whitney)|two-tailed Wilcoxan signed-rank sum test||two-tailed Wilcoxan signed-rank sum test|
1751869|NCT00320242|3219057|Superiority||Mean Difference (Final Values)|50.0|Standard Error of the Mean|11.7||0.005|2-Sided|95.0|23.9|76.1|||t-test, 2 sided||||
1751870|NCT00320242|3219058|Superiority||Mean Difference (Final Values)|1.25|Standard Error of the Mean|0.48||0.0152|2-Sided|95.0|0.26|2.23|||t-test, 2 sided|two-tailed paired t-test|||
1751871|NCT00320216|3219061|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [≤ 90kg vs > 90 kg)].||Null Hypothesis: No difference between any ustekinumab group and placebo.|
1751872|NCT00320216|3219061|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square||||
1751873|NCT00320216|3219061|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [≤ 90kg vs > 90 kg)].|||
1751874|NCT00320216|3219061|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [≤ 90kg vs > 90 kg)].|||
1751875|NCT00320216|3219062|Superiority or Other||||||<|0.01||||||To control for the multiplicity for the primary endpoint analysis, the 4 pairwise comparisons between ustekinumab groups and placebo were performed sequentially at alpha = 0.05. The order of testing was prespecified from high to low doses.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [≤ 90kg vs > 90 kg)].||Null Hypothesis:No difference between any ustekinumab group and placebo at an overall significant level of 0.05. Sample Size: With 300 participants (60 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in primary endpoint between ustekinumab groups and placebo using a CMH test with stratification by baseline weight [≤ 90kg vs > 90 kg). For all the scenarios evaluated, the power is >99% at an overall significance level of 0.05.|
1751876|NCT00320216|3219062|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [≤ 90kg vs > 90 kg)].|||
1751877|NCT00320216|3219062|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [≤ 90kg vs > 90 kg)].|||
1751878|NCT00320216|3219062|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel chi square test|Stratified by baseline weight [<=90kg vs > 90 kg].|||
1751879|NCT00320112|3219070|Superiority or Other|||||||0.02|||||||Regression, Linear||||
1751880|NCT00320112|3219071|Superiority or Other|||||||0.1|||||||Regression, Linear||||
1751881|NCT00320112|3219072|Superiority or Other|||||||0.91||||||this is a priori design|Regression, Linear||||
1751882|NCT00320112|3219073|Superiority or Other||Mean Difference (Final Values)|-0.58||||0.004|2-Sided|||||no differences between arms in baseline characteristics at <0.1 level, further analyses adjusted for variables that could influence the outcome like insulin use, age, commodities. because no differences in results, unadjusted analyses are reported.|Regression, Linear|we used STATA 11’s xtmixed command, which fits multi-level mixed-effects linear regression models, with clustering by assigned pairs.|||
1751883|NCT00319982|3219074|Superiority or Other|||||||0.15||||||Adjusted for age, sex, genotype, family relations, and baseline value|Generalized estimating equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families|||
1751884|NCT00319982|3219075|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Percentage adherent to study medication|
1751885|NCT00319982|3219077|Superiority or Other||||||<|0.001||||||Adjusted for age, sex, genotype, family relations, and baseline value|Generalized Estimating Equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||Change in LV End-Diastolic Diameter z-score from baseline to final visit|
1751886|NCT00319982|3219078|Superiority or Other||||||>|0.06||||||Adjusted for age, sex, genotype, family relations, and baseline value. p<0.05 considered statistically significant.|Generalized Estimating Equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families|||
1751887|NCT00319982|3219079|Superiority or Other|||||||0.99|||||||Fisher Exact|||Adverse Events|
1751888|NCT00319982|3219080|Superiority or Other|||||||0.75||||||Adjusted for age, sex, genotype, family relations, and baseline value. p<0.05 considered statistically significant.|Generalized estimating equation|Generalized estimating equation approach accounting for an exchangeable correlation structure within families||Change in E' Velocity comparing baseline and final study visits|
1751889|NCT00319956|3219084|Superiority|||||||0.2|||||||Chi-squared||||
1751890|NCT00319644|3219122|Superiority or Other||Mean Difference (Final Values)|20.0||||0.26||95.0|||||Chi-squared|||The chi-square test(or Fisher exact test where needed) was used to compare proportions with dichotomous variables. The Student-t test was used for quantitative variables woth normal distribution, and Mann-Whitney-U test was used for data not normally distributed.|
1751891|NCT00319501|3219137|Superiority or Other||Difference in least square means|0.79||||0.045|2-Sided|95.0|0.02|1.56||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|ANOVA||Model included treatment and age category.||
1751892|NCT00319501|3219138|Superiority or Other||Difference in least square means|0.75||||0.086|2-Sided|95.0|-0.11|1.61||p-Value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha = 0.05.|ANOVA|ANOVA=analysis of variance.|Model included treatment and age category.||
1751895|NCT00319501|3219141|Superiority or Other|||||||0.066||||||p-value is unadjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Fisher Exact||||
1751896|NCT00319501|3219143|Superiority or Other||Hazard Ratio (HR)|0.55||||0.012|2-Sided|95.0|0.34|0.88||p-value is adjusted. All statistical tests were 2-sided and employed a level of significance of alpha=0.05.|Cox Proportional Hazard||Age adjusted|Null hypothesis|
1751897|NCT00318656|3219226|Superiority or Other||Mean Difference (Net)|-0.26|Standard Error of the Mean|1.45||0.923||95.0|-3.37|2.85||P value von elteren (adjusted on sex)|ANCOVA||Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)|Statistical analysis was based off of week 12 results.|
1751898|NCT00318656|3219227|Superiority or Other||Mean Difference (Net)|5.02|Standard Error of the Mean|2.49||0.064||95.0|-0.32|10.36|||ANCOVA|Analysis of covariance (ANCOVA)|Mean Difference =(Rosiglitazone + Met) - (Glimepiride+Met)|Statistical analysis was based off of week 12 results.|
1751899|NCT00318591|3219231|Non-Inferiority or Equivalence|ANOVA. Level of significant difference <0.05||||||0.0074||||||baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.|ANOVA||||
1751900|NCT00318591|3219232|Non-Inferiority or Equivalence|ANOVA analysis. Limit of significant difference <0.05||||||0.767||||||baseline characteristics were used as covariates, catheterization procedure (participant or caregiver) as well as technique (sterile or clean). Backward elimination was used.|ANOVA||||
1751901|NCT00318591|3219234|Non-Inferiority or Equivalence|The additional explanatory variables were removed using backwards-elimination removing the least significant additional variable for each iteration, until the effect of all included additional variables was significant on α=0.05 significant level. The null-hypothesis of no catheter difference was to be rejected on α=0.05 significant level.|Hazard Ratio (HR)|1.502||||0.0383|2-Sided|95.0|1.022|2.207||p-value is adjusted for the following explanatory variables: catheterization frequency, technique (clean/sterile), procedure (participant/nurse), setting (hospital/community) and demographic measures.|Kaplan-Meier|||The analysis was done by comparing Kaplan-Meier estimates of the survival function of the two groups. The analysis was refined by a Cox proportional hazards regression model for survival data.|
1751902|NCT00318565|3219235|Superiority or Other||Binomial Distribution|1.5||||0.05|1-Sided|95.0||7.0|||Exact Binomial Distribution|||The anticipated rate of the CSAE is 2.7% and the one-sided 95% upper confidence bound will be compared to 7%|
1751903|NCT00318565|3219236|Superiority or Other||Binomial distribution|93.3||||0.05|1-Sided|95.0|90.1||||Exact binomial distribution|||An acute success rate of 88% is anticipated and the one-sided 95% lower confidence bound will be compared to 80%. The statistical hypothesis for the primary efficacy endpoint is evaluated as a one-tailed hypothesis at a = 0.05.|
1751904|NCT00318461|3219241|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|53.23||||0.2978||95.0|-26.3|132.76|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751905|NCT00318461|3219241|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|72.38||||0.1818||95.0|-23.15|167.9|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751906|NCT00318461|3219241|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|16.05||||0.9689||95.0|-63.69|95.79|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751907|NCT00318461|3219241|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|35.2||||0.7292||95.0|-60.33|130.72|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751908|NCT00318461|3219241|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|6.56||||0.9989||95.0|-72.66|85.79|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751909|NCT00318461|3219241|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|25.71||||0.8821||95.0|-69.84|121.26|||ANCOVA|||Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1752027|NCT00316914|3219362|Superiority or Other|||||||0.4048|||||||Log Rank|||Comparison of Time to Onset of Grade 3+ Chronic Neurotoxicity between Arms|
1752028|NCT00316914|3219363|Superiority or Other|||||||0.0503|||||||Log Rank|||Comparison of time to Onset of Grade 2+ Chronic Neurotoxicity between Arms|
1751910|NCT00318461|3219242|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-4.23||||0.9293||95.0|-20.78|12.31|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751911|NCT00318461|3219242|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|22.08||||0.0253||95.0|2.15|42.01|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751912|NCT00318461|3219242|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-4.36||||0.9227||95.0|-20.94|12.22|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751913|NCT00318461|3219242|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|21.96||||0.0263||95.0|2.04|41.87|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751914|NCT00318461|3219242|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|1.44||||0.9987||95.0|-15.03|17.9|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751915|NCT00318461|3219242|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|27.75||||0.0031||95.0|7.83|47.67|||ANCOVA|||Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751916|NCT00318461|3219243|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.7871||95.0|-0.35|0.76|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751917|NCT00318461|3219243|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.16||||0.0003||95.0|-1.86|-0.46|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751918|NCT00318461|3219243|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.42||||0.2005||95.0|-0.98|0.14|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751919|NCT00318461|3219243|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.79|||<|0.0001||95.0|-2.49|-1.08|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751920|NCT00318461|3219243|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.3|||<|0.5048||95.0|-0.86|0.26|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1752117|NCT00315445|3219624|Superiority or Other||Day 84 Mean|39.0|||||2-Sided|90.0|29.0|40.3|||||||
1751921|NCT00318461|3219243|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.66|||<|0.0001||95.0|-2.37|-0.96|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751922|NCT00318461|3219244|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.78||||0.0008||95.0|0.27|1.29|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751923|NCT00318461|3219244|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.06||||0.0003||95.0|-1.71|-0.42|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751924|NCT00318461|3219244|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.13||||0.9368||95.0|-0.39|0.64|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751925|NCT00318461|3219244|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.72|||<|0.0001||95.0|-2.36|-1.07|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751926|NCT00318461|3219244|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.11|||<|0.967||95.0|-0.62|0.41|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751927|NCT00318461|3219244|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.95|||<|0.0001||95.0|-2.6|-1.3|||ANCOVA|||Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751928|NCT00318461|3219245|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.02||||0.9998||95.0|-0.38|0.42|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751929|NCT00318461|3219245|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.07||||0.9887||95.0|-0.57|0.43|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751930|NCT00318461|3219245|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.28||||0.2678||95.0|-0.68|0.12|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1752029|NCT00316914|3219364|Superiority or Other|||||||0.038||||||A priori threshold for the p-value is 0.05 and there was no adjustment for multiple comparisons.|Chi-squared|||Comparison in Percentage of Patients With Oxaliplatin-induced Grade 2+ Chronic Neuropathic Adverse Event between Arms|
1752030|NCT00316888|3219369|Superiority or Other|||||||0.592|||||||one sample binomial test|||The null hypothesis is that the local failure rate at 3 years is no more than 35%.|
1752118|NCT00315445|3219624|Superiority or Other||Day 84 Mean|35.3|||||2-Sided|90.0|24.3|35.6|||||||
1751931|NCT00318461|3219245|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.36||||0.2063||95.0|-0.86|0.14|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751932|NCT00318461|3219245|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.15||||0.7644||95.0|-0.55|0.25|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751933|NCT00318461|3219245|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.24||||0.5282||95.0|-0.74|0.26|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751934|NCT00318461|3219246|Non-Inferiority or Equivalence|A test for superiority of glimepiride+metformin to placebo metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.75|||<|0.0001||95.0|-0.99|-0.51|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1751935|NCT00318461|3219246|Non-Inferiority or Equivalence|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.14|||<|0.0052||95.0|-0.06|0.34|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1751936|NCT00318461|3219246|Non-Inferiority or Equivalence|"Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin.~Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%."|Estimated treatment difference, LS Mean|-0.61|||<|0.0001||95.0|-0.85|-0.37|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1751937|NCT00318461|3219246|Non-Inferiority or Equivalence|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.07|||<|0.0001||95.0|-0.27|0.13|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1751938|NCT00318461|3219246|Non-Inferiority or Equivalence|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.81|||<|0.0001||95.0|-1.05|-0.57|||ANCOVA|||Change in HbA1c from baseline to end of treatment was at 104 weeks analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1751939|NCT00318461|3219246|Non-Inferiority or Equivalence|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.08|||<|0.0001||95.0|-0.28|0.12|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1751940|NCT00318461|3219246|Non-Inferiority or Equivalence|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.83|||<|0.0001||95.0|-1.07|-0.59|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1752031|NCT00316888|3219369|Superiority or Other|||||||0.218|||||||one sample binomial test|||Null hypothesis is that the local failure rate at 3 years is no more than 35%.|
1752032|NCT00316719|3219389|Non-Inferiority or Equivalence|This is a Non-inferiority Analysis with the margin of -1.0.|Mean Difference (Net)|-0.33|Standard Error of the Mean|0.309|<|0.001||95.0|-0.94|0.28|||ANCOVA||||
1752119|NCT00315445|3219625|Superiority or Other|||||||0.0962|||||||Mixed Models Analysis||||
1755488|NCT00265616|3225325|Superiority or Other|||||||0.4|||||||Fisher Exact||||
1751941|NCT00318461|3219247|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.4831||95.0|-0.18|0.6|||ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751942|NCT00318461|3219247|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.21||||0.6201||95.0|-0.28|0.7|||ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751943|NCT00318461|3219247|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.04||||0.9984||95.0|-0.35|0.43|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751944|NCT00318461|3219247|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.03||||0.9994||95.0|-0.46|0.52|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751945|NCT00318461|3219247|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.12||||0.8695||95.0|-0.51|0.27|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751946|NCT00318461|3219247|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.13||||0.8871||95.0|-0.62|0.36|||ANCOVA|||Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1751947|NCT00318461|3219248|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.15||||0.9006||95.0|-0.7|0.39|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.|
1751948|NCT00318461|3219248|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.55|||<|0.0001||95.0|-2.2|-0.9|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.|
1751949|NCT00318461|3219248|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.55|||<|0.0451||95.0|-1.1|-0.01|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.|
1751950|NCT00318461|3219248|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.95|||<|0.0001||95.0|-2.6|-1.3|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.|
1752033|NCT00316602|3219424|Non-Inferiority|The non-inferiority margin to show that Group 2 (Atopic Dermatitis Participants) is non-inferior to Group 1 (Healthy Participants) in terms of seroconversion rate at Week 6 was predefined as -5% for the difference in seroconversion rates.|Difference in seroconversion rates (%)|-1.2|||||1-Sided|97.5|-4.3||||||||
1752216|NCT00313300|3219813|Superiority or Other||Cox Proportional Hazard|0.86|||||2-Sided|95.0|0.29|2.57|||||||
1752217|NCT00313300|3219813|Superiority or Other||Cox Proportional Hazard|1.13|||||2-Sided|95.0|0.44|2.88|||||||
1751951|NCT00318461|3219248|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.53|||<|0.0542||95.0|-1.08|0.01|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.|
1751952|NCT00318461|3219248|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.93|||<|0.0001||95.0|-2.58|-1.28|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.|
1751953|NCT00318461|3219249|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|0.18||||0.8079||95.0|-0.32|0.67|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.|
1751954|NCT00318461|3219249|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.53|||<|0.0001||95.0|-2.12|-0.94|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.|
1751955|NCT00318461|3219249|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.33|||<|0.3047||95.0|-0.82|0.17|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.|
1751956|NCT00318461|3219249|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.04|||<|0.0001||95.0|-2.63|-1.44|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.|
1751957|NCT00318461|3219249|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.38|||<|0.1845||95.0|-0.87|0.11|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.|
1751958|NCT00318461|3219249|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.09|||<|0.0001||95.0|-2.68|-1.5|||ANCOVA|||Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.|
1751959|NCT00318461|3219250|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.77|||<|0.0001||95.0|-3.67|-1.87|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1751960|NCT00318461|3219250|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.27|||<|0.9069||95.0|-1.33|0.8|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1752034|NCT00316524|3219451|Non-Inferiority|The non-inferiority margin to show that Group 4 (vaccinia experienced subjects receiving a single vaccination) is non-inferior to Group 1 (vaccinia naive subjects receiving 2 vaccinations) in terms of seroconversion rate 2 weeks after the last vaccination was predefined as -5% for the difference in seroconversion rates|Difference in seroconversion rates (%)|-3.4|||||1-Sided|97.5|-7.36||||||||
1752035|NCT00316303|3219454|Superiority or Other|||||||0.6|||||||Chi-squared||||
1751961|NCT00318461|3219250|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.73|||<|0.0001||95.0|-4.64|-2.83|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1751962|NCT00318461|3219250|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.23|||<|0.0185||95.0|-2.3|-0.16|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1751963|NCT00318461|3219250|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.61|||<|0.0001||95.0|-4.51|-2.72|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1751964|NCT00318461|3219250|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.11|||<|0.0378||95.0|-2.18|-0.05|||ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1751965|NCT00318461|3219251|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-2.73|||<|0.0001||95.0|-3.47|-2.0|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1751966|NCT00318461|3219251|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-0.28|||<|0.8198||95.0|-1.15|0.6|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1751967|NCT00318461|3219251|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.53|||<|0.0001||95.0|-4.27|-2.79|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1751968|NCT00318461|3219251|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.07|||<|0.0117||95.0|-1.94|-0.19|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1751969|NCT00318461|3219251|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-3.75|||<|0.0001||95.0|-4.48|-3.01|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1751970|NCT00318461|3219251|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.|Estimated treatment difference, LS Mean|-1.29|||<|0.0016||95.0|-2.16|-0.41|||ANCOVA|||Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1751971|NCT00318461|3219252|Non-Inferiority or Equivalence|A test for superiority of glimepiride+metformin to metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-1.07|||<|0.0001||95.0|-1.28|-0.86|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1751972|NCT00318461|3219252|Non-Inferiority or Equivalence|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.29|||<|0.1026||95.0|0.12|0.46|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1751973|NCT00318461|3219252|Non-Inferiority or Equivalence|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-0.78|||<|0.0001||95.0|-0.99|-0.57|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1751974|NCT00318461|3219252|Non-Inferiority or Equivalence|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|0.01|||<|0.0001||95.0|-0.16|0.18|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1751975|NCT00318461|3219252|Non-Inferiority or Equivalence|Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.|Estimated treatment difference, LS Mean|-1.06|||<|0.0001||95.0|-1.27|-0.85|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1751976|NCT00318461|3219252|Non-Inferiority or Equivalence|Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.|Estimated treatment difference, LS Mean|-0.02|||<|0.0001||95.0|-0.19|0.15|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1751977|NCT00318461|3219252|Non-Inferiority or Equivalence|"Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin.~Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%."|Estimated treatment difference, LS Mean|-1.09|||<|0.0001||95.0|-1.3|-0.88|||ANCOVA|||Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.|
1751978|NCT00318409|3219255|Superiority or Other|||||||0.98|||||||Wilcoxon (Mann-Whitney)||||
1751979|NCT00318357|3219268|Superiority|||||||0.007|||||||Regression, Cox|||Mortality is compared between the arms of the CARE-HF study, using Cox proportional hazards regression. Data from the original CARE-HF trial and the CARE-HF Long Term Follow-up trial were combined for the analysis.|
1751980|NCT00318292|3219269|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.003||95.0|-3.2|-0.7|||t-test, 2 sided||||
1751981|NCT00318149|3219282|Non-Inferiority|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS01E Group) was smaller than (<) 2.0.|Geometric mean ratio|1.07|||||2-Sided|98.75|0.79|1.44||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01E administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.|
1751982|NCT00318149|3219282|Non-Inferiority|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS01B Group) was smaller than (<) 2.0.|Geometric mean ratio|1.04|||||2-Sided|98.75|0.79|1.38||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS01B administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.|
1751983|NCT00318149|3219282|Non-Inferiority|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS50 Group) was smaller than (<) 2.0.|Geometric mean ratio|1.05|||||2-Sided|98.75|0.71|1.56||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS50 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.|
1752036|NCT00316303|3219455|Superiority or Other|||||||0.011|||||||Wald Chi-squared||||
1752037|NCT00316303|3219456|Superiority or Other||||||<|0.001|||||||Wald Chi-squared||||
1752038|NCT00316303|3219457|Superiority or Other||||||<|0.001|||||||Wald Chi-squared||||
1752039|NCT00316303|3219458|Superiority or Other||||||<|0.001|||||||Wald Chi-squared||||
1752040|NCT00316173|3219511|Superiority or Other||Percentage of participants with CR+PR|30.9||||||95.0|18.7|43.1|||||||
1751984|NCT00318149|3219282|Non-Inferiority|Non inferiority criteria: The upper limit (UL) of the 2-sided 98.75% confidence interval (CI) on geometric mean ratio of influenza-specific T-cells (between Fluarix 18-40 Y Group and Fluarix-AS25 Group) was smaller than (<) 2.0.|Geometric mean ratio|0.9|||||2-Sided|98.75|0.7|1.16||||||Demonstration of non inferiority of the influenza adjuvanted vaccine Fluarix-AS25 administered to elderly subjects (aged 65 years and older) as compared to the licensed influenza vaccine Fluarix administered to adults (aged 18-40 years) in terms of frequency of influenza-specific CD4 T-cells producing at least 2 different cytokines (CD40L, IL-2, TNF-α or IFN-γ), 21 days post-vaccination.|
1751985|NCT00318136|3219286|Superiority or Other||Percentage of patients|3.2||||||90.0|0.3|13.5|||||||
1751986|NCT00317642|3219308|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1751987|NCT00317642|3219308|Superiority or Other||||||<|0.0506|||||||Fisher Exact||||
1751988|NCT00317642|3219308|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1751989|NCT00317642|3219309|Superiority or Other|||||||0.0017|||||||Fisher Exact|||Participants stratified by randomization strata CR1 >=6 months|
1751990|NCT00317642|3219309|Superiority or Other|||||||0.0088|||||||Fisher Exact|||Participants stratified by randomization strata CR1 <6 months.|
1751991|NCT00317642|3219309|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population|
1751992|NCT00317642|3219310|Superiority or Other||Hazard Ratio (HR)|0.52||||0.0002|2-Sided|95.0|0.37|0.74|||Log Rank||||
1751993|NCT00317642|3219310|Superiority or Other||Hazard Ratio (HR)|0.73||||0.0486|2-Sided|95.0|0.53|1.01|||Log Rank||||
1751994|NCT00317642|3219310|Superiority or Other||Hazard Ratio (HR)|0.63|||<|0.0001|2-Sided|95.0|0.49|0.79|||Log Rank|||Full Analysis Set (FAS) population.|
1751995|NCT00317642|3219311|Superiority or Other||Hazard Ratio (HR)|0.83||||0.2906|2-Sided|95.0|0.59|1.17|||Log Rank||||
1751996|NCT00317642|3219311|Superiority or Other||Hazard Ratio (HR)|1.11||||0.5071|2-Sided|95.0|0.81|1.53|||Log Rank||||
1751997|NCT00317642|3219311|Superiority or Other||Hazard Ratio (HR)|0.97||||0.8209|2-Sided|95.0|0.77|1.23|||Log Rank|||Full Analysis Set (FAS) population|
1751998|NCT00317642|3219312|Superiority or Other||Hazard Ratio (HR)|0.57||||0.0022||95.0|0.4|0.83|||Log Rank|Comparison p-value is from a log-rank test with no strata.||Participants stratified by randomization strata CR1 >=6 months|
1751999|NCT00317642|3219312|Superiority or Other||Hazard Ratio (HR)|0.67||||0.0131|2-Sided|95.0|0.49|0.93|||Log Rank|Comparison P-value is from a log-rank test with no strata||Participants stratified by randomization strata CR1 <6 months|
1752000|NCT00317642|3219312|Superiority or Other||Hazard Ratio (HR)|0.63||||0.0001|2-Sided|95.0|0.49|0.8|||Log Rank|||Full Analysis Set (FAS) population.|
1752001|NCT00317642|3219317|Superiority or Other|||||||0.0096|||||||Fisher Exact|||Participants stratified by calculated strata - CR1 >=6 months [Complete Remission (CR)]|
1752002|NCT00317642|3219317|Superiority or Other|||||||0.0353|||||||Fisher Exact|||Participants stratified by calculated strata - CR1 <6 months [Complete Remission (CR)]|
1752003|NCT00317642|3219317|Superiority or Other|||||||0.0019|||||||Fisher Exact|||Participants stratified by calculated strata - CR1 >=6 months [Overall Remission (CR+CRi)]|
1752004|NCT00317642|3219317|Superiority or Other|||||||0.0022|||||||Fisher Exact|||Participants stratified by calculated strata - CR1 <6 months [Overall Remission (CR+CRi)]|
1752005|NCT00317642|3219317|Superiority or Other|||||||0.0005|||||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population - Complete Remission (CR)|
1752006|NCT00317642|3219317|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|||Full Analysis Set (FAS) population - overall remission (OR)|
1752007|NCT00317642|3219318|Superiority or Other||Hazard Ratio (HR)|0.85||||0.3963|2-Sided|95.0|0.58|1.24|||Log Rank|||Participants stratified by calculated strata CR1>= 6 months|
1752008|NCT00317642|3219318|Superiority or Other||Hazard Ratio (HR)|1.13||||0.4674|2-Sided|95.0|0.81|1.57|||Log Rank|||Participants stratified by calculated strata remission after first pre-study induction regimen (CR1) < 6 months|
1752009|NCT00317642|3219318|Superiority or Other||Hazard Ratio (HR)|1.0||||0.9951|2-Sided|95.0|0.78|1.28|||Log Rank|||Full Analysis Set (FAS) population|
1752010|NCT00316914|3219353|Superiority or Other|||||||0.2181|||||||Kruskal-Wallis|||Tingling in Fingers, Toes (Week 2 - Baseline)|
1752011|NCT00316914|3219353|Superiority or Other|||||||0.5105|||||||Kruskal-Wallis|||Numbness in Fingers, Toes (Week 2 - Baseline)|
1752012|NCT00316914|3219353|Superiority or Other|||||||0.4715|||||||Kruskal-Wallis|||Swallowing (Week 2 - Baseline)|
1752013|NCT00316914|3219353|Superiority or Other|||||||0.9283|||||||Kruskal-Wallis|||Shortness of Breath (Week 2 - Baseline)|
1752014|NCT00316914|3219353|Superiority or Other|||||||0.2439|||||||Kruskal-Wallis|||Bowel Problems with Normal Activity|
1752015|NCT00316914|3219353|Superiority or Other|||||||0.8601|||||||Kruskal-Wallis|||Abdominal Cramping|
1752016|NCT00316914|3219353|Superiority or Other|||||||0.3103|||||||Kruskal-Wallis|||Constipation|
1752017|NCT00316914|3219353|Superiority or Other|||||||0.5124|||||||Kruskal-Wallis|||Diarrhea|
1752018|NCT00316914|3219353|Superiority or Other|||||||0.6988|||||||Kruskal-Wallis|||Buttoning Shirt or Tying Laces|
1752019|NCT00316914|3219353|Superiority or Other|||||||0.6275|||||||Kruskal-Wallis|||Walking|
1752020|NCT00316914|3219353|Superiority or Other|||||||0.9364|||||||Kruskal-Wallis|||Fatigue WORST|
1752021|NCT00316914|3219354|Superiority or Other|||||||0.9364|||||||Kruskal-Wallis|||Comparison of Fatigue WORST between two arms|
1752022|NCT00316914|3219354|Superiority or Other|||||||0.201|||||||Kruskal-Wallis|||Comparison of Fatigue USUAL between two arms|
1752023|NCT00316914|3219354|Superiority or Other|||||||0.234|||||||Kruskal-Wallis|||Comparison of Fatigue NOW between two arms|
1752024|NCT00316914|3219357|Superiority or Other|||||||0.7498|||||||Chi-squared|||Comparison of Percentage of Patients With Acute Neuropathic Adverse Event between Arms|
1752025|NCT00316914|3219360|Superiority or Other|||||||0.3238|||||||Chi-squared|||Comparison of Percentage of patients discontinuing therapy for chronic neurotoxicity between Arms|
1752026|NCT00316914|3219361|Superiority or Other|||||||0.6556|||||||Log Rank|||Comparison of Average Duration of Chronic Neuropathic Toxicity between Arms|
1752041|NCT00316017|3219520|Superiority or Other|||||||0.34||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received greater than 10 units of PRBC.|
1752042|NCT00316017|3219521|Superiority or Other|||||||0.35||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received greater than 10 units of PRBC.|
1752043|NCT00316017|3219523|Superiority or Other|||||||0.97||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received greater than 10 units of PRBC in first 24 hours between the three groups.|
1752044|NCT00316017|3219524|Superiority or Other|||||||0.31||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received 1-9 units of PRBC.|
1752045|NCT00316017|3219525|Superiority or Other|||||||0.83||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 6 hours of admission to the hospital between the three groups among the patients who received 1-9 units of PRBC.|
1752046|NCT00316017|3219526|Superiority or Other|||||||0.73||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died in Field or ED between the three groups among the patients who received 1-9 units of PRBC.|
1752047|NCT00316017|3219527|Superiority or Other|||||||0.51||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received 1-9 units PRBC in the first 24 hours between the three groups.|
1752048|NCT00316017|3219528|Superiority or Other||||||<|0.01||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died within 28 days from the time of the 911 call between the three groups among the patients who received zero units of PRBC.|
1752049|NCT00316017|3219529|Superiority or Other||||||<|0.02||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in percent of patients who died within 6 hours of admission to the hospital between the three groups among patients who received zero units of PRBC.|
1752050|NCT00316017|3219530|Superiority or Other||||||<|0.01||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died in field or ED between the three groups among the patients who received zero units of PRBC.|
1752051|NCT00316017|3219531|Superiority or Other|||||||0.48||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who received zero units of PRBC in the first 24 hours between the three groups.|
1752052|NCT00316017|3219532|Superiority or Other|||||||0.85||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who survived to hospital discharge between the three groups.|
1752053|NCT00316017|3219533|Superiority or Other|||||||0.98||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Days alive out of the hospital through day 28 between the three groups.|
1752054|NCT00316017|3219534|Superiority or Other|||||||0.82||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Days alive out of the ICU through day 28 between the three groups.|
1752055|NCT00316017|3219535|Superiority or Other|||||||0.66||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.|
1752056|NCT00316017|3219536|Superiority or Other|||||||0.57||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average amount of Total fluids given within the first 24 hours between the three groups.|
1752057|NCT00316017|3219537|Superiority or Other|||||||0.69||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.|
1752058|NCT00316017|3219538|Superiority or Other|||||||0.8||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients with the Presence of Nosocomial Infection through day 28 between the three groups.|
1752107|NCT00315445|3219619|Superiority or Other||Day 84 Mean|67.8|||||2-Sided|90.0|62.0|68.7|||||||
1752059|NCT00316017|3219539|Superiority or Other|||||||0.73||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|ANOVA|||The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.|
1752060|NCT00316017|3219540|Superiority or Other|||||||0.94||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in ARDS-free survival through day 28 between the three groups.|
1752061|NCT00316017|3219541|Superiority or Other|||||||0.91||||||The Statistical Analysis applies to the 7.5% hypertonic saline/6% Dextran-70 (HSD),7.5% hypertonic saline (HS), and 0.9% normal saline groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who survived to day 28 day between the three groups.|
1752062|NCT00316004|3219542|Superiority or Other|||||||0.17||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to skilled nursing facilities between the three groups.|
1752063|NCT00316004|3219542|Superiority or Other|||||||0.16||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to inpatient rehabilitation facilities between the three groups.|
1752064|NCT00316004|3219542|Superiority or Other|||||||0.26||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients who were discharged alive from the hospital to home between the three groups.|
1752065|NCT00316004|3219542|Superiority or Other|||||||0.88||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for proportions|||The null hypothesis is that there are no differences in the percent of patients who died during hospitalization between the three groups.|
1752066|NCT00316004|3219543|Superiority or Other|||||||0.43||||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|||The null hypothesis is that there are no differences in the average number of PRBC units given within the first 24 hours between the three groups.|
1752067|NCT00316004|3219544|Superiority or Other|||||||0.68||||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|||The null hypothesis is that there are no differences in the average amount of total fluids given within the first 24 hours between the three groups.|
1752068|NCT00316004|3219545|Superiority or Other|||||||0.88||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with wound infections through hospital stay between the three groups.|
1752069|NCT00316004|3219545|Superiority or Other|||||||0.06||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with urinary tract infections through hospital stay between the three groups.|
1752070|NCT00316004|3219545|Superiority or Other|||||||0.04||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with bloodstream infections through hospital stay between the three groups.|
1752071|NCT00316004|3219545|Superiority or Other|||||||0.3||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with pneumonia through hospital stay between the three groups.|
1752072|NCT00316004|3219545|Superiority or Other|||||||0.06||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent of patients with any nosocomial infections through hospital stay between the three groups.|
1752073|NCT00316004|3219546|Superiority or Other|||||||0.43||||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of days alive out of the hospital through day 28 between the three groups.|
1752074|NCT00316004|3219547|Superiority or Other|||||||0.76||||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of days alive out of the ICU through day 28 between the three groups.|
1752075|NCT00316004|3219548|Superiority or Other|||||||0.77||||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the average number of Ventilator-free days through day 28 between the three groups.|
1752076|NCT00316004|3219549|Superiority or Other|||||||0.81||||||The p-value was not adjusted for multiple comparisons. Test compares averages across all three treatment groups.|ANOVA|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in average Worst Multiple Organ Dysfunction Scores (MODS) through day 28 between the three groups.|
1752108|NCT00315445|3219619|Superiority or Other||Day 84 Mean|68.8|||||2-Sided|90.0|61.7|68.8|||||||
1752109|NCT00315445|3219619|Superiority or Other||Day 84 Mean|67.4|||||2-Sided|90.0|61.3|68.6|||||||
1752110|NCT00315445|3219620|Superiority or Other||Day 84 Mean|63.0|||||2-Sided|90.0|53.1|70.9|||||||
1752077|NCT00316004|3219550|Superiority or Other|||||||0.91||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive and free of ARDS from the day of injury to the 28th day after injury between the three groups.|
1752078|NCT00316004|3219551|Superiority or Other|||||||0.88||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive on the day discharged from the hospital after injury between the three groups.|
1752079|NCT00316004|3219552|Superiority or Other|||||||0.88||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|The numbers differ from the JAMA manuscript because of typos and version control issues that were discovered after publication.||The null hypothesis is that there are no differences in the percent of patients who were alive on the 28th day after injury between the three groups.|
1752080|NCT00316004|3219553|Superiority or Other|||||||0.84||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent of patients at any level of disability between the three groups.|
1752081|NCT00316004|3219554|Superiority or Other|||||||0.57||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥2.|
1752082|NCT00316004|3219555|Superiority or Other|||||||0.67||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations.||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.|
1752083|NCT00316004|3219556|Superiority or Other|||||||0.59||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|Adjusted for multiple imputations||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three treatment groups among patients with head AIS≥4.|
1752084|NCT00316004|3219557|Superiority or Other|||||||0.55||||||The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups.|test for differences in proportions|||The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups.|
1752085|NCT00315939|3219559|Superiority or Other||||||=|0|||||||ANOVA||||
1752086|NCT00315822|3219560|Superiority or Other||Risk Ratio (RR)|0.94||||0.8|2-Sided|95.0|0.52|1.68|||Cochran-Mantel-Haenszel||||
1752087|NCT00315731|3219568|Non-Inferiority or Equivalence|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of Cmax|0.98|||||2-Sided|90.0|0.87|1.11|||||||
1752088|NCT00315731|3219569|Non-Inferiority or Equivalence|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0 to infinity)|0.93|||||2-Sided|90.0|0.78|1.1|||||||
1752089|NCT00315731|3219570|Non-Inferiority or Equivalence|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0-168)|0.96|||||2-Sided|90.0|0.83|1.11|||||Ratio of AUC(0-168) is the ratio of AUC(0-168) values following infusion of fission-derived 131I-tositumomab to those following infusion of tellurium-derived 131I-tositumomab.||
1752090|NCT00315731|3219571|Non-Inferiority or Equivalence|Comparability of AUC values after dosimetric dose of fission-derived 131I-tositumomab with historical data from tellurium-derived 131I-tositumomab|Ratio of AUC(0-120)|0.97|||||2-Sided|90.0|0.85|1.12|||||Ratio of AUC(0-120) is the ratio of AUC(0-120) values following infusion of fission-derived 131I-tositumomab to those following infusion of tellurium-derived 131I-tositumomab.||
1752091|NCT00315445|3219607|Superiority or Other|||||||0.634|||||||Mixed Models Analysis||||
1752092|NCT00315445|3219607|Superiority or Other|||||||0.702|||||||Mixed Models Analysis||||
1752093|NCT00315445|3219608|Superiority or Other|||||||0.94|||||||Mixed Models Analysis||||
1752094|NCT00315445|3219608|Superiority or Other|||||||0.607|||||||Mixed Models Analysis||||
1752095|NCT00315445|3219609|Superiority or Other|||||||0.066|||||||Mixed Models Analysis||||
1752096|NCT00315445|3219609|Superiority or Other|||||||0.064|||||||Mixed Models Analysis||||
1752097|NCT00315445|3219610|Superiority or Other|||||||0.63|||||||Mixed Models Analysis||||
1752098|NCT00315445|3219610|Superiority or Other|||||||0.038|||||||Mixed Models Analysis||||
1752099|NCT00315445|3219611|Superiority or Other|||||||0.034|||||||Mixed Models Analysis||||
1752100|NCT00315445|3219611|Superiority or Other|||||||0.011|||||||Mixed Models Analysis||||
1752101|NCT00315445|3219612|Superiority or Other|||||||0.043|||||||Mixed Models Analysis||||
1752102|NCT00315445|3219612|Superiority or Other|||||||0.033|||||||Mixed Models Analysis||||
1752103|NCT00315445|3219613|Superiority or Other||Hazard Ratio (HR)|0.04||||0.0024|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.|||
1752104|NCT00315445|3219613|Superiority or Other||Hazard Ratio (HR)|0.3||||0.0105|||||||Regression, Cox|For the secondary outcomes no alpha adjustment for multiple comparison was performed.|||
1752105|NCT00315445|3219614|Superiority or Other||Hazard Ratio (HR)|1.51||||0.138|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.|||
1752106|NCT00315445|3219614|Superiority or Other||Hazard Ratio (HR)|1.67||||0.054|||||||Regression, Cox|For the secondary outcome measure no alpha adjustment for multiple comparison was performed.|||
1752120|NCT00315445|3219625|Superiority or Other|||||||0.0452||||||Multiple linear regression|Mixed Models Analysis|||A repeated measures analysis was performed to assess the effects due to treatment, center, and treatment by center interaction. Observations within each subject were assumed to follow a first-order autoregressive model. Missing values were extrapolated by the last observation carried forward (LOCF). Covariates were gender, age, race, weight, baseline pain, and previous opioid use which were incorporated into the model when P < 0.10, using a backward elimination procedure.|
1752121|NCT00315445|3219626|Superiority or Other||Day 84 Mean|33.9|||||2-Sided|90.0|16.0|35.2|||||||
1752122|NCT00315445|3219626|Superiority or Other||Day 84 Mean|24.4|||||2-Sided|90.0|10.7|32.0|||||||
1752123|NCT00315445|3219626|Superiority or Other||Day 84 Mean|18.9|||||2-Sided|90.0|5.2|26.2|||||||
1752124|NCT00315445|3219627|Superiority or Other||Day 84 Mean|46.5|||||2-Sided|90.0|41.7|50.2|||||||
1752125|NCT00315445|3219627|Superiority or Other||Day 84 Mean|44.5|||||2-Sided|90.0|43.3|52.4|||||||
1752126|NCT00315445|3219627|Superiority or Other||Day 84 Mean|46.4|||||2-Sided|90.0|40.2|48.7|||||||
1752127|NCT00315445|3219628|Superiority or Other|||||||0.0624||||||Repeated measures analysis to assess the effects due to treatment, center, and treatment by center. Missing values = last observation carried forward (LOCF). Covariates: gender, age, race, weight, baseline pain, and previous opioid use.|Mixed Models Analysis||||
1752128|NCT00315445|3219628|Superiority or Other|||||||0.035||||||P values are from a repeated measures model|Mixed Models Analysis|||A repeated measures analysis was performed to assess the effects due to treatment, center, and treatment by center interaction. Observations within each subject were assumed to follow a first-order autoregressive model. Missing values were extrapolated by the last observation carried forward (LOCF). Covariates were gender, age, race, weight, baseline pain, and previous opioid use which were incorporated into the model when P < 0.10, using a backward elimination procedure.|
1752129|NCT00315341|3219629|Superiority or Other||||||<|0.05|||||||shift table analyses|||categorized changes in ALT/AST from BL:(1)BL transaminases(both ALT/AST)≤2X upper limit of normal(ULN)& remained at this level;(2)BL transaminases ≤2X ULN(either ALT/AST)but increased(either ALT/AST)above this level at any time;(3)BL transaminases >2X ULN(either ALT/AST)& decreased and remained at ≤2X ULN(both ALT/AST);(4)BL transaminases(both ALT/AST)>2X ULN &remained at this level(both ALT/AST);(5)BL transaminases >2X ULN(either ALT/AST)& increased 2X above this level ever(either ALT/AST).|
1752130|NCT00315328|3219631|Superiority or Other||Mean Difference (Net)|1.3|||||2-Sided|95.0|0.4|2.2||||||95% confidence interval constructed on the treatment group difference of mean change in fellow eye visual acuity from baseline to 17 weeks, adjusted for baseline fellow eye visual acuity.|
1752131|NCT00315328|3219634|Non-Inferiority or Equivalence|Treatment equivalence was to be declared if the ends of the 2 1-sided 95% confidence intervals constructed on the difference between adjusted mean visual acuity scores were completely contained within the designated equivalence interval of +/- 5 letters.|Mean Difference (Net)|1.2||||||95.0|-0.7|3.1||||||The trial was designed to evaluate whether patching and atropine are equivalent treatments for amblyopia in children 7 to 12 years old. The sample size was computed based on a standard deviation of 17-week visual acuity scores of 10 letters, correlation between outcome and baseline visual acuity scores of 0.30 and 10% loss to follow up.|
1752132|NCT00315328|3219635|Superiority or Other||Mean Difference (Net)|0.08||||||95.0|-0.02|0.18||||||95% confidence interval constructed on the treatment group difference of the proportion improving 15 or more letters from baseline to 17 weeks.|
1752133|NCT00315328|3219637|Superiority or Other||Mean Difference (Net)|0.07||||||95.0|-0.03|0.17||||||95% confidence interval constructed on the treatment group difference in proportion with amblyopic eye visual acuity 20/25 or better at 17 weeks.|
1752134|NCT00315328|3219638|Superiority or Other|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Adverse events subscale.|
1752135|NCT00315328|3219639|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Positive mean favors atropine group.||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Compliance subscale.|
1752136|NCT00315328|3219640|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|Positive mean favors atropine group.||Wilcoxon rank sum tests were used to assess treatment group differences in the parent questionnaire subscale scores at 17 weeks - Social Stigma subscale.|
1752137|NCT00315328|3219641|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)|||To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zero|
1752138|NCT00315328|3219641|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||To evaluate WITHIN each treatment group whether stereoacuity changed from baseline to outcome a Wilcoxon sign-rank test was performed to evaluate whether the distribution of change from baseline was zero|
1752139|NCT00315328|3219642|Superiority or Other|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among patients with strabismus or combined mechanism only.|
1752140|NCT00315328|3219643|Superiority or Other|||||||0.78|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests used to assess treatment group differences in change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination) among those with anisometropia only.|
1752141|NCT00315328|3219644|Superiority or Other|||||||0.96|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank sum tests were used to assess treatment group differences in the change in Randot Preschool stereoacuity levels ( from baseline to the outcome examination).|
1752142|NCT00315302|3219646|Superiority or Other|||||||0.003|||||||Fisher Exact|||"Null hypothesis: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups;~Alternate: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups"|
1752143|NCT00315302|3219648|Superiority or Other|||||||0.9|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group||Among anisometropic patients only|
1752144|NCT00315302|3219649|Superiority or Other|||||||0.39|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group||All patients without respect to cause of amblyopia.|
1752145|NCT00315302|3219650|Superiority or Other|||||||0.39|||||||Regression, Logistic|proportion 20/25 as a function of treatment group controlling for baseline acuity||"Null hypothesis: proportion 3 or more lines better at 18wks in atropine group = proportion 3 or more lines better at 18wks in atropine plus plano group~Alternative hypothesis: proportion 3 or more lines better at 18wks in atropine group NOT equal to proportion 3 or more lines better at 18wks in atropine plus plano group"|
1752146|NCT00315302|3219651|Superiority or Other||Mean Difference (Final Values)|5.1|Standard Deviation|3.7|||2-Sided|95.0|3.7|6.4||||||95% confidence interval calculated within treatment group on the amount of change from baseline|
1752147|NCT00315302|3219651|Superiority or Other||Mean Difference (Final Values)|4.5|Standard Deviation|3.1|||2-Sided|95.0|3.2|5.8||||||95% confidence interval calculated within treatment group on the amount of change from baseline|
1752148|NCT00315302|3219652|Superiority or Other|||||||0.03|||||||Regression, Logistic|proportion 20/25 as a function of treatment group controlling for baseline acuity||"Null hypothesis: proportion 20/25 or better at 18wks in atropine group = proportion 20/25 or better at 18wks in atropine plus plano group~Alternative hypothesis: proportion 20/25 or better at 18wks in atropine group NOT equal to proportion 20/25 or better at 18wks in atropine plus plano group"|
1752149|NCT00315302|3219653|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Deviation|0.24||0.21||95.0|-0.2|0.8|||ANCOVA||The difference was calculated as atropine plus plano group minus atropine group|"The primary analysis was a treatment group comparison of logMAR visual acuity scores in the amblyopic eye obtained 18 weeks after randomization, adjusted for baseline acuity scores in an analysis of covariance (ANCOVA) model.~The primary analysis included only patients with visual acuity of 20/40 to 20/100; sample size was based upon a two-sided alpha of 0.05, with 90% power to detect a difference if the true difference in change from baseline between groups was 0.075 logMAR at 18 weeks."|
1752150|NCT00315120|3219676|Superiority or Other||Response ratio|1.1||||0.72|2-Sided|95.0|0.7|1.7|||Chi-squared||||
1752151|NCT00315120|3219681|Superiority or Other||Response ratio|2.0||||0.007|2-Sided|95.0|1.2|3.2|||Chi-squared||||
1752152|NCT00314951|3219688|Superiority or Other||Risk Difference (RD)|10.2||||0.007|2-Sided|95.0|2.8|17.5|||Chi-squared||||
1752153|NCT00314951|3219689|Superiority or Other||Risk Difference (RD)|-9.4||||0.008|2-Sided|95.0|-16.2|-2.5|||Chi-squared||||
1752154|NCT00314951|3219690|Non-Inferiority or Equivalence|The point estimate of the difference and the 2-sided 95% confidence interval (CI) for the difference between treatment groups were computed. If the lower limit of the CI was greater than -10%, the clinical non-inferiority of fidaxomicin was demonstrated. CIs for the difference of cure rates were calculated using the method recommended by Agresti and Caffo.|Risk Difference (RD)|2.6|||||2-Sided|95.0|-2.9|8.0||||||H0: C(fidaxomicin) – C(Vancomycin) <= -10% Power calculation is based on cure rate of 85% in both treatment groups, non-inferiority margin of 10%, 2.5% (1-sided) type I error rate with approximately 90% power gives a total of 530 subjects.|
1752155|NCT00314249|3219729|Superiority or Other||Mean Difference (Net)|1.65||||||95.0|0.86|2.44||||||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.|
1752156|NCT00314249|3219730|Superiority or Other||Odds Ratio (OR)|1.86|||<|0.001||95.0|1.38|2.51||Closed testing procedure was used to control overall type 1 error rate at 5%: fibromyalgia pain tested after statistically significant fibromyalgia syndrome test|Regression, Logistic|||The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with the treatment group and baseline pain score as explanatory variables.|
1752157|NCT00314249|3219731|Superiority or Other||Odds Ratio (OR)|2.06|||<|0.001||95.0|1.45|2.94||Closed testing procedure used to control overall type 1 error rate at 5%: fibromyalgia syndrome tested prior to fibromyalgia pain|Regression, Logistic|||The test of no difference in the responder rate between milnacipran and placebo groups was performed using a logistic regression model with treatment group, baseline pain score, and baseline SF-36 PCS score as explanatory variables.|
1752158|NCT00314249|3219732|Superiority or Other||Mean Difference (Net)|-1.69||||||95.0|-3.27|-0.11||||||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.|
1752159|NCT00314249|3219733|Superiority or Other||Mean Difference (Net)|-0.53||||||95.0|-0.69|-0.38||||||This parameter was analyzed using an ANOVA model with treatment group and study center as factors.|
1752160|NCT00314249|3219734|Superiority or Other||Mean Difference (Net)|-6.38||||||95.0|-8.56|-4.19||||||This parameter was analyzed using an ANCOVA model with treatment group and study center as factors and baseline value as a covariate.|
1752161|NCT00314236|3219737|Superiority or Other|||||||0.033|||||||ANCOVA||||
1752162|NCT00314236|3219738|Superiority or Other|||||||0.011|||||||ANCOVA||||
1752163|NCT00313846|3219755|Superiority or Other|||||||0.0026|||||||Kaplan-Meier estimate mean||||
1752164|NCT00313820|3219758|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.14||0.049||95.0|-0.6|0.0||Estimated from ANCOVA (general linear model) with treatment and country as factors.|ANCOVA|||Modelled Results|
1752165|NCT00313820|3219759|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.14||0.144||95.0|-0.5|0.1||Estimated from ANCOVA (general linear model) with treament and country as factors.|ANCOVA|||Modelled Results|
1752166|NCT00313820|3219760|Superiority or Other||Mean Difference (Final Values)|3.0|Standard Error of the Mean|2.47||0.22||95.0|-1.8|7.9||Estimated from ANCOVA (general linear model) with treatment and coutntry as factors and baseline score as a covariate.|ANCOVA|||Modelled Results|
1752167|NCT00313820|3219761|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.04||0.566||95.0|-0.1|0.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Modelled Results|
1752168|NCT00313820|3219762|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.41||0.6||95.0|-0.6|1.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Week 12 [LOCF] Depression score; Modelled Results|
1752218|NCT00313300|3219814|Superiority or Other||Adjusted Rate Difference|10.4|||||2-Sided|95.0|5.6|15.1|||||||
1752219|NCT00313300|3219814|Superiority or Other||Adjusted Rate Difference|17.4|||||2-Sided|95.0|11.6|23.2|||||||
1752169|NCT00313820|3219762|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.4||0.015||95.0|-1.8|-0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Week 12 [LOCF] Anxiety score; Modelled Results|
1752170|NCT00313820|3219763|Superiority or Other||Odds Ratio (OR)|1.5|Standard Error of the Mean|0.5||0.201||95.0|0.8|2.9||Estimated from a logistic regression model with treatment and the baseline assessment as factors.|Regression, Logistic||Standard error of the mean = standard error of the odds ratio.|Modelled Results|
1752171|NCT00313820|3219764|Superiority or Other||Mean Difference (Final Values)|-4.2|Standard Error of the Mean|2.13||0.049||95.0|-8.4|0.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Overall sleep problems index; Modelled Results|
1752172|NCT00313820|3219764|Superiority or Other||Mean Difference (Final Values)|2.1|Standard Error of the Mean|2.51||0.399||95.0|-2.8|7.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Somnolence; Modelled Results|
1752173|NCT00313820|3219764|Superiority or Other||Mean Difference (Final Values)|8.6|Standard Error of the Mean|3.44||0.013||95.0|1.8|15.4||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep adequacy; Modelled Results|
1752174|NCT00313820|3219764|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.17||0.03||95.0|0.0|0.7||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep quantity; Modelled Results|
1752175|NCT00313820|3219764|Superiority or Other||Mean Difference (Final Values)|-3.7|Standard Error of the Mean|2.71||0.169||95.0|-9.1|1.6||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Awaken SOB or headache; Modelled Results|
1752176|NCT00313820|3219764|Superiority or Other||Mean Difference (Final Values)|7.7|Standard Error of the Mean|3.72||0.039||95.0|0.4|15.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Snoring score; Modelled Results|
1752177|NCT00313820|3219764|Superiority or Other||Mean Difference (Final Values)|-4.8|Standard Error of the Mean|2.79||0.086||95.0|-10.3|0.7||Estimated from ANCOVA (general linear model) with treatment and country as factors and the baseline assessment as a covariate.|ANCOVA|||Sleep disturbance; Modelled Results|
1752178|NCT00313820|3219765|Superiority or Other||Mean Difference (Final Values)|-2.8|Standard Error of the Mean|1.87||0.138||95.0|-6.5|0.9||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Total Score Week 12 [LOCF]; Modelled Results|
1752179|NCT00313820|3219765|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.27||0.118||95.0|-1.0|0.1||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||P/D Week 12 [LOCF]; Modelled Results|
1752180|NCT00313820|3219765|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.26||0.239||95.0|-0.8|0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Evoked Pain Week 12 [LOCF]; Modelled Results|
1752181|NCT00313820|3219765|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.24||0.36||95.0|-0.7|0.3||Estimated from ANCOVA (general linear model) general linear model with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Paroxysmal Pain Week 12 [LOCF]; Modelled Results|
1752182|NCT00313820|3219765|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.25||0.76||95.0|-0.4|0.6||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Pressing Pain Week 12 [LOCF]; Modelled Results|
1752183|NCT00313820|3219765|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.31||0.216||95.0|-1.0|0.2||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline score as a covariate.|ANCOVA|||Burning Pain Week 12 [LOCF]; Modelled Results|
1752184|NCT00313820|3219766|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|3.05||0.741||95.0|-7.0|5.0||Estimated from ANCOVA (general linear model) with treatment and country as factors and baseline value as a covariate|ANCOVA|||Modelled Results|
1752185|NCT00313820|3219767|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.26||0.627||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Endpoint [Week 12 or ET]; Modelled Results|
1752186|NCT00313820|3219767|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.24||0.663||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 12; Modelled Results|
1752187|NCT00313820|3219767|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.24||0.078||95.0|-0.9|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 9; Modelled Results|
1752188|NCT00313820|3219767|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.24||0.005||95.0|-1.1|-0.2||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 6; Modelled Results|
1752189|NCT00313820|3219767|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.24||0.004||95.0|-1.2|-0.2||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 3; Modelled Results|
1752220|NCT00313300|3219814|Superiority or Other||Adjusted Rate Difference|10.9|||||2-Sided|95.0|3.4|18.4|||||||
1752190|NCT00313820|3219767|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.24||0.038||95.0|-1.0|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 2; Modelled Results|
1752191|NCT00313820|3219767|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.23||0.027||95.0|-1.0|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 1; Modelled Results|
1752192|NCT00313820|3219768|Superiority or Other|||||||0.622||||||Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.|Cochran-Mantel-Haenszel|||50% Responders|
1752193|NCT00313820|3219769|Superiority or Other|||||||0.087||||||Cochran-Mantel-Haenszel (CMH) test comparing pregabalin to placebo adjusted for country under the null hypothesis of no treatment difference.|Cochran-Mantel-Haenszel|||30% Responders|
1752194|NCT00313820|3219770|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.25||0.592||95.0|-0.6|0.4||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 12 Modelled Results|
1752195|NCT00313820|3219770|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.25||0.105||95.0|-0.9|0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 9 Modelled Results|
1752196|NCT00313820|3219770|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.25||0.026||95.0|-1.1|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 6 Modelled Results|
1752197|NCT00313820|3219770|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.25||0.024||95.0|-1.1|-0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 3 Modelled Results|
1752198|NCT00313820|3219770|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.25||0.062||95.0|-1.0|0.0||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 2 Modelled Results|
1752199|NCT00313820|3219770|Superiority or Other||Mean Difference (Final Values)|-0.3|Standard Error of the Mean|0.25||0.161||95.0|-0.8|0.1||Estimated from a repeated measures linear mixed model with treatment, week, country and treatment by week interaction as factors and baseline value as a covariate. A compound symmetry covariance structure is specified.|Mixed Models Analysis|||Week 1 Modelled Results|
1752200|NCT00313820|3219771|Superiority or Other|||||||0.294||||||Interaction p-value based on adding interaction term to the main model.|ANCOVA|||Modelled Results: Treatment by country interaction|
1752201|NCT00313820|3219771|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.29||0.578||95.0|-0.7|0.4|||ANCOVA|ANCOVA with treatment and country as factors and baseline pain score as covariate.||Modelled Results: Endpoint Mean Pain Score Pregabalin vs Placebo|
1752202|NCT00313716|3219788|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.26|2-Sided|95.0|-0.22|0.05|||2-sample test - equality of proportions||||
1752203|NCT00313716|3219789|Superiority or Other||Hazard Ratio (HR)|1.79||||0.08|2-Sided|95.0|0.93|3.45|||Regression, Cox||||
1752204|NCT00313716|3219790|Superiority or Other|||||||0.72|||||||Log Rank||||
1752205|NCT00313716|3219790|Superiority or Other|||||||0.75|||||||Log Rank||||
1752206|NCT00313716|3219790|Superiority or Other|||||||0.25|||||||Log Rank||||
1752207|NCT00313716|3219791|Superiority or Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)||||
1752208|NCT00313716|3219792|Superiority or Other|||||||0.34|||||||2-sample test of proportions|||We hypothesized that 40% of the patients in the TT7 group would have a favorable GOS score and that there would be no interaction between the Epo and TT groups. Assuming a 2-sided test with an alpha level of 0.05, we estimated that a sample size of 200 patients would provide 80% power to detect a 20% absolute increase in the GOS score for the TT10 group.|
1752209|NCT00313716|3219792|Superiority or Other|||||||0.13||||||"H0: Proportion of participants expected to have a favorable GOS outcome in the Epo1 group - in Placebo group is >= 0.2.~H1: Proportion in Epo1 group - in Placebo group < 0.2"|Futility analysis|||The primary analysis plan was a futility trial of the Epo 1 regimen arm. We hypothesized that 30% of subjects in the placebo group would have a favorable outcome at six months and there would be no interaction between the Epo and the transfusion threshold groups.|
1752210|NCT00313716|3219792|Superiority or Other|||||||0.01||||||"H0: Proportion of participants expected to have a favorable GOS outcome in the Epo2 group - in Placebo group is >= 0.2.~H1: Proportion in Epo2 group - in Placebo group < 0.2"|Futility analysis|||The primary analysis plan was a futility trial of the Epo 2 regimen arm. We hypothesized that 30% of subjects in the placebo group would have a favorable outcome at six months and there would be no interaction between the Epo and the transfusion threshold groups. Using a one-sided alpha of 0.15, a sample size of 62 subjects in the Epo 2 regimen group and 100 subjects in the placebo group provided 91% power to test the futility hypothesis.|
1752211|NCT00313300|3219812|Superiority or Other||Adjusted Rate Difference|4.1|||||2-Sided|95.0|1.3|6.9|||||||
1752212|NCT00313300|3219812|Superiority or Other||Adjusted Rate Difference|2.9|||||2-Sided|95.0|0.6|5.1|||||||
1752213|NCT00313300|3219812|Superiority or Other||Adjusted Rate Difference|0.8|||||2-Sided|95.0|-0.9|2.6|||||||
1752214|NCT00313300|3219813|Superiority or Other||Cox Proportional Hazard|0.72|||||2-Sided|95.0|0.3|1.74|||||||
1752215|NCT00313300|3219813|Superiority or Other||Cox Proportional Hazard|0.71|||||2-Sided|95.0|0.3|1.66|||||||
1752221|NCT00313300|3219814|Superiority or Other||Adjusted Rate Difference|8.3|||||2-Sided|95.0|1.8|14.9|||||||
1752222|NCT00313300|3219815|Superiority or Other||Adjusted Rate Difference|4.7|||||2-Sided|95.0|1.4|8.0|||||||
1752223|NCT00313300|3219815|Superiority or Other||Adjusted Rate Difference|7.0|||||2-Sided|95.0|3.4|10.5|||||||
1752224|NCT00313300|3219815|Superiority or Other||Adjusted Rate Difference|4.7|||||2-Sided|95.0|0.0|9.3|||||||
1752225|NCT00313300|3219815|Superiority or Other||Adjusted Rate Difference|4.0|||||2-Sided|95.0|0.0|8.1|||||||
1752226|NCT00313300|3219816|Superiority or Other||Hazard Ratio (HR)|0.72|||||2-Sided|95.0|0.3|1.74|||||||
1752227|NCT00313300|3219816|Superiority or Other||Hazard Ratio (HR)|0.71|||||2-Sided|95.0|0.3|1.66|||||||
1752228|NCT00313300|3219816|Superiority or Other||Hazard Ratio (HR)|0.86|||||2-Sided|95.0|0.29|2.57|||||||
1752229|NCT00313300|3219816|Superiority or Other||Hazard Ratio (HR)|1.13|||||2-Sided|95.0|0.44|2.88|||||||
1752230|NCT00313300|3219817|Superiority or Other||Adjusted Rate Difference|0.8|||||2-Sided|95.0|-1.1|2.7|||||adjusted difference of event rates takes into consideration stratification factors.||
1752231|NCT00313300|3219817|Superiority or Other||Adjusted rate difference|0.3|||||2-Sided|95.0|-1.3|2.0|||||adjusted difference of event rates takes into consideration stratification factors.||
1752232|NCT00313300|3219818|Superiority or Other||Hazard Ratio (HR)|0.63|||||2-Sided|95.0|0.37|1.07|||||||
1752233|NCT00313300|3219818|Superiority or Other||Hazard Ratio (HR)|0.71|||||2-Sided|95.0|0.44|1.17|||||||
1752234|NCT00313300|3219819|Superiority or Other||Adjusted Rate Difference|10.0|||||2-Sided|95.0|4.8|15.2|||||adjusted difference of event rates takes into consideration stratification factors.||
1752235|NCT00313300|3219819|Superiority or Other||Adjusted rate difference|6.6|||||2-Sided|95.0|1.8|11.3|||||adjusted difference of event rates takes into consideration stratification factors.||
1752236|NCT00313300|3219820|Superiority or Other||Hazard Ratio (HR)|0.61|||||2-Sided|95.0|0.35|1.04|||||||
1752237|NCT00313300|3219820|Superiority or Other||Hazard Ratio (HR)|0.73|||||2-Sided|95.0|0.44|1.19|||||||
1752238|NCT00313300|3219821|Superiority or Other||Adjusted Rate Difference|3.8|||||2-Sided|95.0|0.4|7.3|||||adjusted difference of event rates takes into consideration stratification factors.||
1752239|NCT00313300|3219821|Superiority or Other||Adjusted rate difference|2.2|||||2-Sided|95.0|-1.0|5.4|||||adjusted difference of event rates takes into consideration stratification factors.||
1752240|NCT00313209|3219822|Superiority or Other||Mean Difference (Net)|0.5|Standard Error of the Mean|0.9||0.5457|2-Sided|95.0|-1.2|2.2||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).|||
1752241|NCT00313209|3219823|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.2||0.4654|2-Sided|95.0|-0.2|0.4||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).|||
1752242|NCT00313209|3219824|Superiority or Other||Rate ratio|0.79|Standard Error of the Mean|0.12||0.1408|2-Sided|95.0|0.58|1.08||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|Poisson regression||||
1752243|NCT00313209|3219825|Superiority or Other||Mean Difference (Net)|60.0|Standard Error of the Mean|11.0|<|0.0001|2-Sided|95.0|38.0|82.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).|||
1752244|NCT00313209|3219826|Superiority or Other||Mean Difference (Net)|49.0|Standard Error of the Mean|11.0|<|0.0001|2-Sided|95.0|27.0|71.0||No adjustment of the significance level (0.05) was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 24 weeks of treatment taking all post-randomization measurements into account).|||
1752245|NCT00313144|3219847|Superiority or Other|||||||0.046|||||||Paired t-test||||
1752246|NCT00313144|3219848|Superiority or Other|||||||0.044|||||||Paired t-test||||
1752247|NCT00313144|3219849|Superiority or Other|||||||0.006|||||||Paired t-test||||
1752248|NCT00313144|3219851|Superiority or Other|||||||0.005|||||||Paired t-test||||
1752249|NCT00313144|3219852|Superiority or Other|||||||0.009|||||||Paired t-test||||
1752250|NCT00313144|3219854|Superiority or Other|||||||0.044|||||||Paired t-test||||
1752251|NCT00313014|3219857|Superiority or Other||Mean Difference (Final Values)|-2.65|Standard Error of the Mean|1.709||0.121||95.0|-6.01|0.7||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that BTDS 20 arm was different from the BTDS 5 arm.|
1752252|NCT00313014|3219857|Superiority or Other||Mean Difference (Final Values)|-6.23|Standard Error of the Mean|1.735|<|0.001|2-Sided|95.0|-9.64|-2.82||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|Mixed linear model: treatment, time as fixed effects, screening, prerandomization sleep disturbance subscale as covariates; subject as a random effect||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.|
1752253|NCT00313014|3219858|Superiority or Other||Mean Difference (Final Values)|-1.99||||0.031||95.0|-3.79|-0.18||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.|
1752254|NCT00313014|3219858|Superiority or Other||Mean Difference (Final Values)|-1.72||||0.065|2-Sided|95.0|-3.55|0.11||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|Mixed Models Analysis|||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.|
1752255|NCT00313014|3219859|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.158|2-Sided|95.0|-0.7|0.09||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||The analysis was based on the number of subjects who took > 1 tablet of supplemental analgesia.|The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.|
1752256|NCT00313014|3219859|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.006|2-Sided|95.0|-0.9|-0.13||To address the issue of multiplicity and control the family-wise error rate, a gate-keeping strategy and a stepwise approach (Holm's methodology) were used to evaluate the statistical significance of the secondary efficacy analyses.|ANCOVA||The analysis was based on the number of subjects who took > 1 tablet of supplemental analgesia.|The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.|
1752257|NCT00313014|3219860|Superiority or Other||Mean Difference (Final Values)|-0.75|Standard Error of the Mean|0.161|<|0.001|2-Sided|95.0|-1.07|-0.44||P value was 2-sided and performed at the 5% error level.|Mixed Models Analysis|Repeated measures mixed linear model with treatment, time, and time by treatment interaction as fixed effect.||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.|
1752258|NCT00313014|3219860|Superiority or Other||Mean Difference (Final Values)|-0.67|Standard Error of the Mean|0.163|<|0.001|2-Sided|95.0|-0.99|-0.35||P value was 2-sided and performed at the 5% error level.|Mixed Models Analysis|Repeated measures mixed linear model with treatment, time, and time by treatment interaction as fixed effects.||The null hypothesis was that there was no difference between BTDS 20 or oxycodone HCl immediate-release 40 mg with respect to BTDS 5. The alternative hypothesis was that the BTDS 20 arm was different from the BTDS 5 arm.|
1752259|NCT00312858|3219890|Non-Inferiority or Equivalence|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|2-Sided|95.0|1.0|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 23F|
1752260|NCT00312858|3219890|Non-Inferiority or Equivalence|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|2-Sided|95.0|0.9|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 19F|
1752261|NCT00312858|3219890|Non-Inferiority or Equivalence|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|2-Sided|95.0|0.9|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 18C|
1752262|NCT00312858|3219890|Non-Inferiority or Equivalence|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.0|||<|0.001|2-Sided|95.0|0.9|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 14|
1752263|NCT00312858|3219890|Non-Inferiority or Equivalence|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|0.9|||<|0.001|2-Sided|95.0|0.8|1.0|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 9V|
1752264|NCT00312858|3219890|Non-Inferiority or Equivalence|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.0|||<|0.001|2-Sided|95.0|0.8|1.2|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 6B|
1752265|NCT00312858|3219890|Non-Inferiority or Equivalence|Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more|Response ratio (Arm 1 / Arm 2)|1.1|||<|0.001|2-Sided|95.0|0.9|1.3|||ANCOVA||Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer|Serotype 4|
1752266|NCT00312858|3219891|Non-Inferiority or Equivalence|Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference seroresponse rates excluding a decrease of 10 percentage points or more (lower bound >-10.0).|Risk Difference (RD)|-5.1||||0.013||95.0|-9.3|-1.4||Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided multiplicity-adjusted α=0.025 level.|Miettinen and Nurminen|For testing the non-inferiority of 2 proportions. Stratified by investigator.|Difference in estimated response rates of Arm 1 – Arm 2.|Comparison of the difference (percentage points) in estimated response rates of Arm 1 – Arm 2 for participants with initial serostatus <1.25 gpELISA units/mL|
1752287|NCT00312494|3219911|Superiority or Other|||||||0.242||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.|
1752307|NCT00312221|3219928|Superiority or Other||Mean Difference (Final Values)|-0.48||||0.707|2-Sided|95.0|-3.0054|2.0397|||Mixed Models Analysis||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.||
1752267|NCT00312858|3219892|Non-Inferiority or Equivalence|Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference of seroresponse rates excluding a decrease of 10 percentage points or more (lower bound >-10.0).|Risk Difference (RD)|0.7|||<|0.001||95.0|-1.4|3.8||Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided α=0.025 level.|Miettinen and Nurminen|For testing the non-inferiority of 2 proportions. Stratified by investigator.|Difference in estimated response rates of Arm 1 – Arm 2.|Comparison of the difference (percentage points) in estimated response rates of Arm 1 – Arm 2.|
1752268|NCT00312845|3219893|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel||||
1752269|NCT00312845|3219894|Superiority or Other|||||||0.039|||||||Log Rank||||
1752270|NCT00312494|3219907|Superiority or Other|||||||0.3253||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.|
1752271|NCT00312494|3219907|Superiority or Other|||||||0.446||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.|
1752272|NCT00312494|3219908|Superiority or Other|||||||0.3174||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.|
1752273|NCT00312494|3219908|Superiority or Other|||||||0.0728||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.|
1752274|NCT00312494|3219909|Superiority or Other|||||||0.2202||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.|
1752275|NCT00312494|3219909|Superiority or Other|||||||0.4686||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.|
1752276|NCT00312494|3219909|Superiority or Other|||||||0.3623||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.|
1752277|NCT00312494|3219909|Superiority or Other|||||||0.0876||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.|
1752278|NCT00312494|3219909|Superiority or Other|||||||0.2499||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.|
1752279|NCT00312494|3219909|Superiority or Other|||||||0.1063||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.|
1752280|NCT00312494|3219910|Superiority or Other|||||||0.5665||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.|
1752281|NCT00312494|3219910|Superiority or Other|||||||0.2221||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.|
1752282|NCT00312494|3219910|Superiority or Other|||||||0.7581||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.|
1752283|NCT00312494|3219910|Superiority or Other|||||||0.4758||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.|
1752284|NCT00312494|3219910|Superiority or Other|||||||0.6536||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.|
1752285|NCT00312494|3219910|Superiority or Other|||||||0.6138||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.|
1752286|NCT00312494|3219911|Superiority or Other|||||||0.6121||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.|
1752288|NCT00312494|3219911|Superiority or Other|||||||0.7153||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.|
1752289|NCT00312494|3219911|Superiority or Other|||||||0.9049||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.|
1752290|NCT00312494|3219911|Superiority or Other|||||||0.5629||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.|
1752291|NCT00312494|3219911|Superiority or Other|||||||0.6191||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.|
1752292|NCT00312494|3219912|Superiority or Other|||||||0.0796||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.|
1752293|NCT00312494|3219912|Superiority or Other|||||||0.2302||||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.|
1752294|NCT00312494|3219912|Superiority or Other|||||||0.0176||||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.|
1752295|NCT00312494|3219912|Superiority or Other|||||||0.0183||||||The p-values reported are unadjusted for multiple comparisons|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.|
1752296|NCT00312494|3219912|Superiority or Other|||||||0.0694||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.|
1752297|NCT00312494|3219912|Superiority or Other|||||||0.0101||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.|
1752298|NCT00312494|3219913|Superiority or Other|||||||0.1527||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.|
1752299|NCT00312494|3219913|Superiority or Other|||||||0.4125||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.|
1752300|NCT00312494|3219913|Superiority or Other|||||||0.283||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.|
1752301|NCT00312494|3219913|Superiority or Other|||||||0.4025||||||The p-values reported are unadjusted for multiple comparisons.|Mixed Models Analysis|||Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.|
1752302|NCT00312494|3219914|Superiority or Other|||||||0.4274||||||The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.|Mixed Models Analysis|||Week 3 Mixed Model Repeated Measures (MMRM) with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score. Tests were 2-sided and performed at the 0.05 significance level.|
1752303|NCT00312494|3219914|Superiority or Other|||||||0.1077||||||The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.|Mixed Models Analysis|||N=135/arm (405 total) for 85% power for 2-sample t-test (2-sided alpha=0.05) based on true mean difference=3.5 and SD=10. Interim Analysis (IA) to validate sample-size assumptions and adjust sample-size if needed. Based on IA results total sample-size increased to N=223/arm (669 total) to maintain desired power. Null Hypothesis=No statistically significant difference between add-on ziprasidone (higher, lower dose) and add-on placebo groups with respect to the population mean for primary endpoint|
1752304|NCT00312221|3219927|Superiority or Other||Mean Difference (Final Values)|-1.81||||0.443|2-Sided|95.0|-6.4415|2.8255|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.||
1752305|NCT00312221|3219927|Superiority or Other||Mean Difference (Final Values)|-0.96||||0.685|2-Sided|95.0|-5.6177|3.693|||Mixed Models Analysis||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.||
1752306|NCT00312221|3219928|Superiority or Other||Mean Difference (Final Values)|-1.79||||0.187|2-Sided|95.0|-4.4459|0.8706|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.||
1752308|NCT00312221|3219929|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.011|2-Sided|95.0|-1.47|-0.17|||ANCOVA||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.||
1752309|NCT00312221|3219929|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.007|2-Sided|95.0|-1.47|-0.2|||ANCOVA||Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.||
1752310|NCT00312221|3219930|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.14||95.0|-0.8455|0.1189|||Mixed Models Analysis||Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.||
1752311|NCT00312221|3219930|Superiority or Other||Mean Difference (Final Values)|-0.38||||0.126|2-Sided|95.0|-0.8562|0.1054|||Mixed Models Analysis||Treatment comparison between BTDS 20 and BTDS 5 during the 12-week double-blind phase||
1752312|NCT00312208|3219931|Superiority or Other||Hazard Ratio (HR)|0.91||||0.371||95.0|0.75|1.11||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates.|Log Rank||||
1752313|NCT00312208|3219932|Superiority or Other||Hazard Ratio (HR)|1.0||||0.978||95.0|0.86|1.16||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates.|Log Rank||||
1752314|NCT00312195|3219936|Superiority or Other||Odds Ratio (OR)|1.79|Standard Error of the Mean|0.2544||0.0217|2-Sided|95.0|1.09|2.95||P value is from a logistic regression analysis with terms for treatment effect, country and pain site (hip, knee, back and other).|Regression, Logistic||Primary variable was defined as: ratio of the probability of having ineffective treatment divided by the probability of having effective treatment.|H0: the odds of ineffective treatment is the same for subjects receiving placebo as for those receiving BTDS versus the alternative H1: the odds of ineffective treatment is different for subjects receiving placebo from those receiving BTDS.|
1752315|NCT00311766|3219938|Superiority or Other||ANCOVA|0.8|||>|0.05|2-Sided|95.0|||||Fisher Exact|||The primary population was the Full Analysis(FA)population. The FA population included all patients who were randomized and received at least one dose of study medication and who had at least one baseline efficacy parameter recorded|
1752316|NCT00311402|3219953|Superiority or Other||Cox Proportional Hazard|1.34||||0.101||95.0|0.94|1.91|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|
1752317|NCT00311402|3219954|Superiority or Other||Cox Proportional Hazard|1.04||||0.919||95.0|0.48|2.25|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|
1752318|NCT00311402|3219955|Superiority or Other||Cox Proportional Hazard|1.52||||0.043||95.0|1.01|2.29|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|
1752319|NCT00311402|3219956|Superiority or Other||Cox Proportional Hazard|1.16||||0.443||95.0|0.79|1.69|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|
1752320|NCT00311402|3219957|Superiority or Other||Cox Proportional Hazard|1.88||||0.215||95.0|0.69|5.07|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|
1752321|NCT00311402|3219958|Superiority or Other||Cox Proportional Hazard|0.58||||0.192||95.0|0.26|1.31|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|
1752322|NCT00311402|3219959|Superiority or Other||Cox Proportional Hazard|1.02||||0.977||95.0|0.21|5.07|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|
1752323|NCT00311402|3219960|Superiority or Other||Cox Proportional Hazard|0.0||||0.998|1-Sided|95.0|0.0||||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|
1752324|NCT00311402|3219961|Superiority or Other||Cox Proportional Hazard|1.79||||0.223||95.0|0.7|4.54|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|
1752325|NCT00311402|3219962|Non-Inferiority or Equivalence|The non-event rates after 1 year in the Aggrenox group and ASA group are estimated at 94.0% and 91.5%, respectively. The non-inferiority margin was set to 2%. Under these conditions, 500 patients per group were supposed to be enough to detect the non-inferiority of Aggrenox with over 80% power.|Cox Proportional Hazard|1.47||||0.097||95.0|0.93|2.31|||Regression, Cox|||Non-event rate was calculated by using the Kaplan-Meier method and the comparison of groups was made by using the Cox proportional hazard regression model.|
1752326|NCT00311363|3219999|Superiority or Other||Odds Ratio (OR)|0.353||||0.0158||95.0|0.2|0.8||Model included terms for treatment group, randomization IRLS score (Week 24), and pooled study site|Regression, Logistic||||
1752327|NCT00311311|3220000|Superiority or Other||Mean Difference (Final Values)|-8.2||||0.2902|2-Sided|95.0|-23.8|7.3||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|36 months post-transplant|
1752328|NCT00311311|3220000|Superiority or Other||Mean Difference (Final Values)|-14.7||||0.2729|2-Sided|95.0|-41.6|12.1||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|24 months post-transplant|
1752329|NCT00311311|3220000|Superiority or Other||Mean Difference (Final Values)|-18.0||||0.2718|2-Sided|95.0|-50.7|14.7||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|18 months post-transplant|
1752330|NCT00311311|3220001|Superiority or Other|||||||1||||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Month 24 to Month 36|
1752331|NCT00311311|3220001|Superiority or Other|||||||1||||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Month 12 to Month 24|
1752332|NCT00311311|3220001|Superiority or Other|||||||1||||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Conversion to Month 12|
1752333|NCT00311311|3220001|Superiority or Other|||||||0.4286||||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Anti-hypertension From Consent to Conversion|
1752334|NCT00311311|3220002|Superiority or Other|||||||1||||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Month 24 to Month 36|
1752335|NCT00311311|3220002|Superiority or Other|||||||0.0709||||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Month 12 to Month 24|
1752336|NCT00311311|3220002|Superiority or Other|||||||0.6386||||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Conversion to Month 12|
1752337|NCT00311311|3220002|Superiority or Other|||||||0.2573||||||P-value was calculated from 2-sided Fisher's exact test. Alpha is unadjusted.|Fisher Exact|||Use Lipid-Lowering From Consent to Conversion|
1752338|NCT00311311|3220004|Superiority or Other||Mean Difference (Final Values)|-62.3||||0.0293|2-Sided|95.0|-118.2|-6.5||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant|
1752339|NCT00311311|3220004|Superiority or Other||Mean Difference (Final Values)|-67.6||||0.0017|2-Sided|95.0|-108.5|-26.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant|
1752340|NCT00311311|3220004|Superiority or Other||Mean Difference (Final Values)|-72.8||||0.0002|2-Sided|95.0|-108.6|-36.9||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant|
1752341|NCT00311311|3220005|Superiority or Other||Mean Difference (Final Values)|-15.2||||0.6854|2-Sided|95.0|-90.3|59.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant|
1752342|NCT00311311|3220005|Superiority or Other||Mean Difference (Final Values)|-33.3||||0.2341|2-Sided|95.0|-88.7|22.2||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||24 months post-transplant|
1752343|NCT00311311|3220005|Superiority or Other||Mean Difference (Final Values)|-51.3||||0.0797|2-Sided|95.0|-108.9|6.3||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||12 months post-transplant|
1752344|NCT00311311|3220006|Superiority or Other||Mean Difference (Final Values)|0.2||||0.1841|2-Sided|95.0|-0.1|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant|
1752345|NCT00311311|3220006|Superiority or Other||Mean Difference (Final Values)|0.3||||0.0275|2-Sided|95.0|0.0|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant|
1752346|NCT00311311|3220006|Superiority or Other||Mean Difference (Final Values)|0.4||||0.041|2-Sided|95.0|0.0|0.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant|
1752347|NCT00311311|3220007|Superiority or Other||Mean Difference (Final Values)|11.96||||0.3663|2-Sided|95.0|-14.39|38.32||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant|
1752348|NCT00311311|3220007|Superiority or Other||Mean Difference (Final Values)|10.72||||0.2179|2-Sided|95.0|-6.53|27.97||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant|
1752349|NCT00311311|3220007|Superiority or Other||Mean Difference (Final Values)|9.47||||0.3678|2-Sided|95.0|-11.46|30.4||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant|
1752350|NCT00311311|3220008|Superiority or Other||Mean Difference (Final Values)|-1.33||||0.4066|2-Sided|95.0|-4.53|1.86||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant|
1752415|NCT00309985|3220217|Superiority or Other (legacy)|||||||0.0003|||||||Log Rank|||The study was designed to detect a 33.3% improvement in median survival time across treatments with one-sided type I error of 0.025 and 80% power.|
1752520|NCT00307164|3220543|Superiority or Other|||||||0.43|||||||Stratified Wilcoxon rank-sum test||||
1752351|NCT00311311|3220008|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.7536|2-Sided|95.0|-2.68|1.95||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant|
1752352|NCT00311311|3220008|Superiority or Other||Mean Difference (Final Values)|0.6||||0.5902|2-Sided|95.0|-1.63|2.84||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant|
1752353|NCT00311311|3220009|Superiority or Other||Mean Difference (Final Values)|-0.76||||0.6058|2-Sided|95.0|-3.69|2.17||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant|
1752354|NCT00311311|3220009|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.5549|2-Sided|95.0|-2.32|1.26||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant|
1752355|NCT00311311|3220009|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.7361|2-Sided|95.0|-2.09|1.49||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant|
1752356|NCT00311311|3220010|Superiority or Other||Mean Difference (Final Values)|0.27||||0.1182|2-Sided|95.0|-0.07|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||36 months post-transplant|
1752357|NCT00311311|3220010|Superiority or Other||Mean Difference (Final Values)|0.26||||0.019|2-Sided|95.0|0.04|0.48||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||24 months post-transplant|
1752358|NCT00311311|3220010|Superiority or Other||Mean Difference (Final Values)|0.26||||0.028|2-Sided|95.0|0.03|0.48||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|||12 months post-transplant|
1752359|NCT00311311|3220012|Superiority or Other||Mean Difference (Final Values)|1.59||||0.5701|2-Sided|95.0|-4.0|7.18||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant|
1752360|NCT00311311|3220012|Superiority or Other||Mean Difference (Final Values)|1.27||||0.5057|2-Sided|95.0|-2.53|5.07||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant|
1752361|NCT00311311|3220012|Superiority or Other||Mean Difference (Final Values)|0.95||||0.5282|2-Sided|95.0|-2.05|3.94||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant|
1752362|NCT00311311|3220013|Superiority or Other||Mean Difference (Final Values)|2.25||||0.2468|2-Sided|95.0|-1.6|6.1||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant|
1752363|NCT00311311|3220013|Superiority or Other||Mean Difference (Final Values)|3.91||||0.0091|2-Sided|95.0|1.01|6.8||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant|
1752364|NCT00311311|3220013|Superiority or Other||Mean Difference (Final Values)|5.56||||0.0016|2-Sided|95.0|2.2|8.93||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant|
1752365|NCT00311311|3220014|Superiority or Other||Mean Difference (Final Values)|0.009||||0.118|2-Sided|95.0|-0.002|0.02||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant|
1752366|NCT00311311|3220014|Superiority or Other||Mean Difference (Final Values)|0.006||||0.0514|2-Sided|95.0|0.0|0.012||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA|LS mean difference||24 months post-transplant|
1752367|NCT00311311|3220014|Superiority or Other||Mean Difference (Final Values)|0.003||||0.4892|2-Sided|95.0|-0.005|0.011||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant|
1752416|NCT00309608|3220235|Superiority or Other||Mean Difference (Final Values)|-18.95|Standard Error of the Mean|6.13||0.0022||95.0|-31.0|-6.87|||Pairwise comparison based on ANCOVA|||Linagliptin 1 mg vs. Placebo|
1752368|NCT00311311|3220015|Superiority or Other||Mean Difference (Final Values)|-2.48||||0.9339|2-Sided|95.0|-62.54|57.59||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant|
1752369|NCT00311311|3220015|Superiority or Other||Mean Difference (Final Values)|-19.97||||0.4865|2-Sided|95.0|-77.48|37.53||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant|
1752370|NCT00311311|3220015|Superiority or Other||Mean Difference (Final Values)|-37.47||||0.2741|2-Sided|95.0|-105.79|30.85||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant|
1752371|NCT00311311|3220016|Superiority or Other||Mean Difference (Final Values)|1.11||||0.0683|2-Sided|95.0|-0.09|2.31||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|36 months post-transplant|
1752372|NCT00311311|3220016|Superiority or Other||Mean Difference (Final Values)|0.94||||0.0509|2-Sided|95.0|0.0|1.89||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|24 months post-transplant|
1752373|NCT00311311|3220016|Superiority or Other||Mean Difference (Final Values)|0.78||||0.1757|2-Sided|95.0|-0.36|1.91||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|12 months post-transplant|
1752374|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.63||||0.0048|2-Sided|95.0|0.2|1.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 36 Months Post-transplant|
1752375|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.02||||0.7511|2-Sided|95.0|-0.12|0.16||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 36 Months Post-transplant|
1752376|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.14||||0.546|2-Sided|95.0|-0.33|0.62||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 36 Months Post-transplant|
1752377|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.44||||0.1488|2-Sided|95.0|-0.16|1.03||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 36 Months Post-transplant|
1752378|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.59||||0.0006|2-Sided|95.0|0.27|0.92||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 24 Months Post-transplant|
1752379|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.05||||0.3742|2-Sided|95.0|-0.06|0.16||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 24 Months Post-transplant|
1752380|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.28||||0.0845|2-Sided|95.0|-0.04|0.6||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 24 Months Post-transplant|
1752381|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.59||||0.0065|2-Sided|95.0|0.17|1.0||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 24 Months Post-transplant|
1752382|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.58||||0.0003|2-Sided|95.0|0.27|0.88||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 18 Months Post-transplant|
1752383|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.06||||0.238|2-Sided|95.0|-0.04|0.17||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 18 Months Post-transplant|
1752384|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.34||||0.0126|2-Sided|95.0|0.08|0.61||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 18 Months Post-transplant|
1752417|NCT00309608|3220235|Superiority or Other||Mean Difference (Final Values)|-34.92|Standard Error of the Mean|6.16|<|0.0001||95.0|-47.0|-22.8|||Pairwise comparison based on ANCOVA|||Linagliptin 5mg vs. Placebo|
1752385|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.66||||0.0006|2-Sided|95.0|0.3|1.02||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 18 Months Post-transplant|
1752386|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.56||||0.0005|2-Sided|95.0|0.26|0.86||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|Tg 12 Months Post-transplant|
1752387|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.08||||0.1612|2-Sided|95.0|-0.03|0.19||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|HDL 12 Months Post-transplant|
1752388|NCT00311311|3220017|Superiority or Other||Mean Difference (Final Values)|0.41||||0.0022|2-Sided|95.0|0.15|0.67||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|LDL 12 Months Post-transplant|
1752389|NCT00311311|3220017|Superiority or Other||Median Difference (Final Values)|0.74|||<|0.0001|2-Sided|95.0|0.39|1.09||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value,treatment group,time and treatment group by time interaction as fixed effects,and subjects as random effect.ALPAH is unadjusted.|ANCOVA||LS mean difference|TC 12 Months Post-transplant|
1752390|NCT00311311|3220020|Superiority or Other||Mean Difference (Final Values)|0.028||||0.097|2-Sided|95.0|-0.005|0.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|36 months post-transplant|
1752391|NCT00311311|3220020|Superiority or Other||Mean Difference (Final Values)|0.032||||0.0269|2-Sided|95.0|0.004|0.06||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|24 months post-transplant|
1752392|NCT00311311|3220020|Superiority or Other||Mean Difference (Final Values)|0.034||||0.0288|2-Sided|95.0|0.004|0.064||P-value and 95% CI for LS mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|18 months post-transplant|
1752393|NCT00311311|3220020|Superiority or Other||Mean Difference (Final Values)|0.036||||0.0445|2-Sided|95.0|0.001|0.07||P-value and 95% CI for least square (LS) mean difference were calculated from repeated measures ANCOVA mixed model with baseline value, treatment group, time, and treatment group by time interaction as fixed effects, and subjects as random effect.|ANCOVA||LS mean difference|12 months post-transplant|
1752394|NCT00310466|3220075|Superiority or Other|||||||0.55|||||||ANOVA||||
1752395|NCT00310466|3220077|Superiority or Other|||||||0.04|||||||ANOVA||||
1752396|NCT00310466|3220078|Superiority or Other|||||||0.87|||||||ANOVA||||
1752397|NCT00310401|3220101|Superiority or Other|||||||0.98|||||||Paired T Test|||Paired T Test was used to compare the change in PaO2/FiO2 ratio from enrollment to procurement between albuterol and saline treated donors|
1752398|NCT00310310|3220182|Superiority or Other|||||||0.38|||||||t-test, 1 sided||||
1752399|NCT00310310|3220183|Superiority or Other|||||||0.08|||||||t-test, 1 sided||||
1752400|NCT00310310|3220184|Superiority or Other|||||||0.02|||||||t-test, 1 sided||||
1752401|NCT00310310|3220185|Superiority or Other|||||||0|||||||t-test, 1 sided||||
1752402|NCT00310310|3220186|Superiority or Other|||||||0.59|||||||t-test, 1 sided||||
1752403|NCT00310310|3220187|Superiority or Other|||||||0.96|||||||t-test, 1 sided||||
1752404|NCT00310310|3220189|Superiority or Other|||||||0.8|||||||t-test, 1 sided||||
1752405|NCT00310310|3220190|Superiority or Other|||||||0.023|||||||t-test, 1 sided||||
1752406|NCT00310310|3220191|Superiority or Other|||||||0.001|||||||t-test, 1 sided||||
1752407|NCT00310180|3220194|Other|Treatment-by-Age and RS subset was performed via Cox proportional hazard analysis||||||0.004|||||||Regression, Cox|||Treatment interaction test was performed for the 9 age by RS subsets (3 groups for each, age groups <=50 vs. 51-65 vs. 66-75; RS groups 0-10 vs. 11-25 vs. >25) in patients randomized to arms B and C|
1752408|NCT00310180|3220198|Superiority|Since the noninferiority comparison is formulated using a conventional superiority null hypothesis described as above, a type II error corresponds to concluding that Arm B is not inferior when in fact it is. The design therefore uses a one-sided type I error of 10% and is planned to have 95% power (5% type II error). If the null hypothesis is rejected (at the one-sided 10% level), then it will be concluded that endocrine therapy alone is inferior to chemoendocrine therapy.|Hazard Ratio (HR)|1.08||||0.13|2-Sided|95.0|0.94|1.24||One-sided p value for stratified Cox proportional hazard analysis, stratified on recurrence score, tumor size and menopausal status.|Regression, Cox|||This study uses a noninferiority design, but the noninferiority question is formulated using the conventional superiority null hypothesis of equal DFS on the two arms (that is, the null hypothesis is that Arm B is not inferior to Arm C). The alternative hypothesis is that Arm B has substantially worse DFS than Arm C, specified by a hazard ratio for B vs. C of 1.322.|
1752409|NCT00309985|3220212|Superiority or Other (legacy)|||||||0.4|||||||Wilcoxon signed rank test||||
1752410|NCT00309985|3220212|Superiority or Other (legacy)|||||||0.0009|||||||Wilcoxon signed rank test||||
1752411|NCT00309985|3220213|Superiority or Other (legacy)||||||<|0.0001|||||||Fisher Exact||||
1752412|NCT00309985|3220214|Superiority or Other (legacy)||||||<|0.0001|||||||Fisher Exact||||
1752413|NCT00309985|3220215|Superiority or Other (legacy)||||||<|0.0001|||||||Log Rank||||
1752414|NCT00309985|3220216|Superiority or Other (legacy)||||||<|0.0001|||||||Log Rank||||
1752418|NCT00309608|3220235|Superiority or Other||Mean Difference (Final Values)|-29.5|Standard Error of the Mean|6.07|<|0.0001||95.0|-41.4|-17.5|||Pairwise comparison based on ANCOVA|||Linagliptin 10mg vs. Placebo|
1752419|NCT00309608|3220236|Superiority or Other||Odds Ratio (OR)|31.36||||0.001|2-Sided|95.0|4.063|242.028|||Regression, Logistic|||Glimepiride vs. Placebo|
1752420|NCT00309608|3220236|Superiority or Other||Odds Ratio (OR)|12.776||||0.0167|2-Sided|95.0|1.586|102.895|||Regression, Logistic|||Linagliptin 1 mg vs. Placebo|
1752421|NCT00309608|3220236|Superiority or Other||Odds Ratio (OR)|11.715||||0.0214|2-Sided|95.0|1.439|95.351|||Regression, Logistic|||Linagliptin 5 mg vs. Placebo|
1752422|NCT00309608|3220236|Superiority or Other||Odds Ratio (OR)|18.575||||0.0054|2-Sided|95.0|2.367|145.781|||Regression, Logistic|||Linagliptin 10 mg vs. Placebo|
1752423|NCT00309608|3220237|Superiority or Other||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.14||0.0049||95.0|-0.66|-0.12|||Pairwise comparison based on ANCOVA|||"Linagliptin 1 mg vs. Placebo~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using “last observation carried forward” (LOCF)."|
1752424|NCT00309608|3220237|Superiority or Other||Mean Difference (Final Values)|-0.75|Standard Error of the Mean|0.14|<|0.0001||95.0|-1.02|-0.48|||Pairwise comparison based on ANCOVA|||"Linagliptin 5 mg vs. Placebo~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using “last observation carried forward” (LOCF)."|
1752425|NCT00309608|3220237|Superiority or Other||Mean Difference (Final Values)|-0.73|Standard Error of the Mean|0.14|<|0.0001||95.0|-0.99|-0.46|||Pairwise comparison based on ANCOVA|||"Placebo vs. Linagliptin 10 mg~Analysis additionally adjusted for previous anti-diabetic medication.~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)."|
1752426|NCT00309608|3220237|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.14|<|0.0055||95.0|-0.68|-0.12||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 1 mg vs. Placebo~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"|
1752427|NCT00309608|3220237|Superiority or Other||Mean Difference (Final Values)|-0.73|Standard Error of the Mean|0.14|<|0.0001||95.0|-1.01|-0.44||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 5 mg vs. Placebo~missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"|
1752428|NCT00309608|3220237|Superiority or Other||Mean Difference (Final Values)|-0.67|Standard Error of the Mean|0.14|<|0.0001||95.0|-0.95|-0.39||There was no adjustment for multiple testing, however a hierarchy approach to control for the Type-I error was used. If the 10mg was not successful, any analysis of the 5mg will be descriptive, and similarly for the next step for the 1mg.|Pairwise comparison based on ANCOVA|||"Linagliptin 10 mg vs. Placebo~Missing endpoints after 12 weeks of treatment were replaced using Last Observation Carried Forward (LOCF)"|
1752429|NCT00309465|3220238|Superiority or Other|||||||0.031||||||P value is for three strategies in insulin glargine plus bolus group in achievement of fasting blood glucose value of 80-249 mg/dl.|Chi-squared|||Comparison of Achievement of blood glucose values of 80-249 mg/dl.|
1752430|NCT00309465|3220238|Superiority or Other|||||||0.162||||||P value is for three strategies in insulin glargine only group for achievement of 80-249 mg/dl|Chi-squared|||Comparison of Achievement of blood glucose values of 80-249 mg/dl|
1752431|NCT00309465|3220238|Superiority or Other|||||||0.294||||||P value is for three strategies in insulin glargine plus bolus group for fasting blood glucose achievement of 100-179 mg/dl|Chi-squared|||Comparison for Target Achievement of blood glucose values of 100-179 mg/dl|
1752432|NCT00309465|3220238|Superiority or Other|||||||0.332||||||P-value for three dosing strategies in insulin glargine only group in fasting blood glucose achievement of 100-179 mg/dl range.|Chi-squared|||Comparison for Target Blood Glucose Achievement of 100-179 mg/dl|
1752433|NCT00309452|3220245|Superiority or Other|||||||0.002|||||||Chi-squared, Corrected|||Between groups comparison for vocational engagement, adjusted for pretreatment vocational engagement|
1752434|NCT00309452|3220249|Superiority or Other|||||||0.018|||||||Chi-squared, Corrected|||Between groups comparison for hospitalization rates, adjusted for pretreatment hospitalization|
1752435|NCT00309387|3220255|Superiority or Other||Cox Proportional Hazard|0.82||||0.03|2-Sided|95.0|0.68|0.98|||Regression, Cox||||
1752436|NCT00309244|3220256|Superiority or Other|||||||0.0591|||||||Generalized Estimating Equation|Based on Poission distribution|||
1752437|NCT00309244|3220257|Superiority or Other|||||||0.0027|||||||Generalized Estimation Equation|Based on Poisson distribution|||
1752438|NCT00309244|3220258|Superiority or Other||Odds Ratio (OR)|0.409||||0.0066|2-Sided|95.0|0.215|0.78|||Regression, Logistic||Model: Treatment + Site||
1752439|NCT00309244|3220259|Superiority or Other||Odds Ratio (OR)|0.423|||<|0.001|2-Sided|95.0|0.307|0.581|||Regression, Logistic||Model: Treatment + Site||
1752440|NCT00309244|3220260|Superiority or Other||Odds Ratio (OR)|0.774||||0.2793|2-Sided|95.0|0.486|1.231|||Regression, Logistic|||logistic regression analysis with the terms of treatment and baseline HbA1c in the model|
1752441|NCT00309244|3220261|Superiority or Other||Mean Difference (Net)|-17.7|Standard Error of the Mean|5.9||0.0029|2-Sided|95.0|-29.3|-6.1|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline fasting plasma glucose as covariate|
1752442|NCT00309244|3220262|Superiority or Other||Mean Difference (Net)|-1.6|Standard Error of the Mean|0.41||0.0002|2-Sided|95.0|-2.4|-0.7|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline weight as covariate|
1752443|NCT00309244|3220263|Non-Inferiority or Equivalence|Sample size was set to meet regulatory requirement of 250 subjects per arm with 52‑week data, resulting in > 90% power for a non-inferiority test of the difference in 12‑month change of HbA1c scores between treatment groups with non‑inferiority margin of 0.4%, standard deviation of 1.2 and 1‑sided alpha of 0.025. Allowing for a 25% drop-out rate, 677 subjects were randomized.|Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.085|||2-Sided|95.0|-0.05|0.29|||||||
1752444|NCT00308737|3220281|Non-Inferiority or Equivalence|The null hypothesis tested was that the difference in incidence of a decrease of ≥ 15% in FEV1 between the treatment groups not be greater than 5% for TI when compared with the usual care treatment group. Assuming an incidence rate of 15% for FEV1 and a noninferiority criterion of a 5% difference in incidence between the treatment groups, approximately 625 subjects per group were required for 80% power and an alpha of 5% (1 tailed).|Odds Ratio (OR)|-2.4767|||||2-Sided|95.0|-4.5578|-0.3956||||||Logistic regression excluding non-diabetics|
1752445|NCT00308737|3220282|Superiority or Other|||||||0.112|||||||t-test, 2 sided|||Two sample t-test|
1752446|NCT00308737|3220284|Superiority or Other||Odds Ratio, log|0.8509|||||2-Sided|95.0|0.6722|1.077||||||Logistic regression excluding non-diabetics|
1752447|NCT00308737|3220285|Superiority or Other||Odds Ratio (OR)|0.8953|||||2-Sided|95.0|0.6703|1.1958||||||Logistic regression excluding non-diabetics|
1752448|NCT00308737|3220286|Superiority or Other||Odds Ratio (OR)|0.7504|||||2-Sided|95.0|0.251|2.2431||||||Logistic regression excluding non-diabetics|
1752449|NCT00308737|3220287|Superiority or Other||Odds Ratio (OR)|0.6475|||||2-Sided|95.0|0.3432|1.2219||||||Logistic regression excluding non-diabetics|
1752450|NCT00308737|3220288|Superiority or Other||Mean Difference (Net)|0.269|||||2-Sided|95.0|-0.037|0.574||||||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site, and treatment and baseline TLC as a covariate|
1752451|NCT00308737|3220289|Superiority or Other||Mean Difference (Net)|-0.005|||||2-Sided|95.0|-0.042|0.031||||||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site, and treatment and baseline TLC as a covariate|
1752452|NCT00308737|3220290|Superiority or Other||Mean Difference (Net)|0.034|||||2-Sided|95.0|0.008|0.061||||||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site and treatment and baseline FVC as a covariate|
1752453|NCT00308737|3220291|Non-Inferiority or Equivalence|The null hypothesis tested was that the FEV1 change from Baseline for the TI group is no greater than 50 mL/year above the change in the usual care treatment group. Assuming SD of 100 mL/y, 80% power, and 5% (1-tailed) significance level, it was determined that 50 subjects were required for each of the diabetes treatment groups. Final sample size was selected for the incidence of a >= 15% decrease in FEV1 end point.|Mean Difference (Final Values)|0.037|||||2-Sided|95.0|0.016|0.057||||||ANCOVA model with treatment site, diabetes type, and baseline FEV1|
1752454|NCT00308737|3220292|Non-Inferiority or Equivalence|Comparison of TI + Usual Care to Usual Care only|Mean Difference (Final Values)|0.037|||||2-Sided|95.0|0.014|0.06||||||Mixed model repeated measures with fixed effects diabetes type, visit, pooled site and treatment and baseline FEV1 as a covariate|
1752455|NCT00308711|3220300|Non-Inferiority or Equivalence|Non-inferiority margin was rate of cearean section within 15% of Cervidil rate.|Cox Proportional Hazard|28.0||||0.59||95.0|23.86|32.42|||Fisher Exact||||
1752456|NCT00308711|3220300|Non-Inferiority or Equivalence|Non-inferiority (NI) margin was within 15% relative to the rate of cesarean section for the comparator (Cervidil 10 mg dinoprostone vaginal insert).|Cox Proportional Hazard|27.8||||0.64||95.0|23.61|32.31|||Fisher Exact||||
1752457|NCT00308711|3220301|Superiority or Other||Cox Proportional Hazard|1977.0||||0.011||95.0|1977.0|2253.0|||Log Rank||||
1752458|NCT00308711|3220301|Superiority or Other||Kaplan-Meier|1595.5||||0.974||||||The a priori threshold for statistical significance was 0.05.|Log Rank||This was a Kaplan-Meier analysis of median time to vaginal delivery. Cervidil was compared separately to MVI 100 and MVI 50.|Null hypothesis was that there would be no difference in time to vaginal delivery for MVI 100 compared to time to vaginal delivery for Cervidil.|
1752459|NCT00308581|3220368|Superiority or Other||Odds Ratio (OR)|1.1||||0.696||95.0|0.7|1.7||Logistic regression model including terms for treatment arm and geographical region (North America versus Europe).|Regression, Logistic||Direction of comparison is Q4W regimen (active 1) versus Q2W regimen (active 2).|With a sample size of 165 patients per treatment arm, assuming a percentage of responders of 45% with the Q4W regimen, the study had 80% power to show a statistically significant difference in percentage of responders at Week 26 between the two treatment groups, when there is a true difference of 16% in percentage of responders in favor of the Q2W regimen, and using a 2-sided chi-square at the 5% significance level.|
1752460|NCT00308308|3220373|Superiority or Other|||||||0.2131|||||||Generalized Estimating Equation|"Based on Poisson distribution~Model: Treatment + Time Period"|||
1752461|NCT00308308|3220374|Superiority or Other|||||||0.1193|||||||Generalized Estimation Equation|"Based on Poisson distribution~Model: Treatment + Time Period"|||
1752462|NCT00308308|3220375|Superiority or Other||Odds Ratio (OR)|0.825||||0.2786|2-Sided|95.0|0.582|1.169|||Regression, Logistic||Model: Treatment + Site||
1752463|NCT00308308|3220376|Superiority or Other||Odds Ratio (OR)|0.488||||0.0124|2-Sided|95.0|0.278|0.856|||Regression, Logistic||Model: Treatment + Site||
1752464|NCT00308308|3220377|Superiority or Other||Odds Ratio (OR)|0.941||||0.8311|2-Sided|95.0|0.536|1.652|||Regression, Logistic|||logistic regression analysis with the terms of treatment and baseline HbA1c in the model|
1752465|NCT00308308|3220378|Superiority or Other||Mean Difference (Net)|-20.9|Standard Error of the Mean|7.41||0.0052|2-Sided|95.0|-35.4|-6.3|||ANCOVA||||
1752466|NCT00308308|3220379|Superiority or Other||Mean Difference (Net)|-1.8|Standard Error of the Mean|0.42|<|0.0001||95.0|-2.7|-1.0|||ANCOVA|||ANCOVA model with terms of pooled site and treatment as fixed effects and baseline weight as covariate|
1752467|NCT00308308|3220380|Non-Inferiority or Equivalence|Sample size was set to meet regulatory requirement of 250 subjects per arm with 52‑week data, resulting in > 90% power for a non‑inferiority test of the difference in 12‑month change of HbA1c scores between treatment groups with non‑inferiority margin of 0.4%, standard deviation of 1.2 and 1‑sided alpha of 0.025. Allowing for a 15% dropout rate, 589 subjects were randomized.|Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.082|||2-Sided|95.0|0.08|0.4|||||||
1752468|NCT00308139|3220393|Superiority or Other||Geometic Least Squares Mean Ratio|0.95|Standard Error of the Mean|0.042||0.2915|2-Sided|95.0|0.87|1.04|||ANCOVA|||Analysis: Triglycerides data were logarithm-transformed and the change at Week 30 to baseline (Day -3), expressed as the ratio, was analyzed by an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the triglycerides as a covariate. Null hypothesis: no difference between treatments in change from baseline triglycerides. Power: based on the primary measurement.|
1752519|NCT00307164|3220542|Superiority or Other|||||||0.17|||||||Stratified Wilcoxon rank-sum test||||
1752469|NCT00308139|3220396|Superiority or Other||Least Squares Mean Difference|0.4|Standard Error of the Mean|0.74||0.5613|2-Sided|95.0|-1.0|1.9|||ANCOVA|||Analysis: Change in HDL-C from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the HDL as a covariate. Null hypothesis: no difference between treatments in change from baseline HDL. Power: based on the primary measurement.|
1752470|NCT00308139|3220398|Superiority or Other||Least Squares Mean Difference|-8.2|Standard Error of the Mean|3.04||0.0077|2-Sided|95.0|-14.1|-2.2|||ANCOVA|||Analysis: Change in total cholesterol from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the total cholesterol as a covariate. Null hypothesis: no difference between treatments in change from baseline total cholesterol. Power: based on the primary measurement.|
1752471|NCT00308139|3220402|Superiority or Other||Least Squares Mean Difference|-16.9|Standard Error of the Mean|3.8|<|0.0001|2-Sided|95.0|-24.4|-9.4|||ANCOVA|||Analysis: Change in fasting plasma glucose from baseline (Day -3) to Week 30 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the fasting plasma glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline fasting plasma glucose. Power: based on the primary measurement.|
1752472|NCT00308139|3220404|Superiority or Other||Least Squares Mean Difference|-0.08|Standard Error of the Mean|0.612||0.8916|2-Sided|95.0|-1.29|1.12|||ANCOVA|||Analysis: Change in body weight from baseline (Day -3) to Week 30 was analyzed using an analysis of covariance (ANCOVA) model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the body weight as a covariate. Null hypothesis: no difference between treatments in change from baseline body weight. Power: based on the primary measurement.|
1752473|NCT00308139|3220406|Superiority or Other||Least Squares Mean Difference|30.08|Standard Error of the Mean|11.458||0.0124|2-Sided|95.0|6.88|53.28|||ANCOVA|||Analysis: Change in 2h postprandial glucose from baseline (Day -3) to Week 14 was analyzed using an ANCOVA model including treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors, and baseline value of the 2h postprandial glucose as a covariate. Null hypothesis: no difference between treatments in change from baseline 2h postprandial glucose.|
1752474|NCT00308139|3220408|Superiority or Other|||||||0.1513|||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target values of <=6.0% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (<9% or >=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.|
1752475|NCT00308139|3220410|Superiority or Other|||||||0.2042|||||||Cochran-Mantel-Haenszel|||Analysis: Percentage of subjects achieving HbA1c target value of <=6.5% at Week 30 were compared between treatments using CMH test, in which baseline HbA1c stratum (<9% or >=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.|
1752476|NCT00308139|3220412|Superiority or Other|||||||0.0003|||||||Cochran-Mantel-Haenszel|||Analysis: Percentages of subjects achieving HbA1c target value of <7% at Week 30 were compared between treatments using a Cochran-Mantel-Haenszel (CMH) test, in which baseline HbA1c stratum (<9% or >=9%) and concomitant SU use at screening served as the stratification factors. Null hypothesis: no difference between treatments in percentage of subjects achieving HbA1c target. Power: based on the primary measurement.|
1752477|NCT00308139|3220415|Non-Inferiority or Equivalence|The choice of a 0.4% noninferiority margin was resulted from the considerations of expected clinical benefit of BYETTA in this study based on clinical data evaluating exenatide LAR and BYETTA, regulatory guidance, published literature, and statistical considerations.|Least Squares Mean Difference|-0.33|Standard Error of the Mean|0.107||0.0023|2-Sided|95.0|-0.54|-0.12|||ANOVA|Analysis of variance (ANOVA) model includes treatment, baseline HbA1c stratum (<9% or >=9%), and concomitant SU use at screening as factors.||Superiority of exenatide long-acting release (LAR) once weekly to BYETTA if the upper limit of the 2-sided 95% confidence interval (CI) for treatment difference (LAR minus BYETTA) is less than 0; non-inferiority if this upper limit is less than 0.4%. Power:Assuming 20% dropout rate with 246 subjects will complete the study. This sample size would provide 90% power for non-inferiority test with assumption of greater reduction (0.1%) in LAR and a common standard deviation of 1.2%.|
1752478|NCT00308087|3220420|Superiority or Other|||||||0.8217|||||||Log Rank|||Log rank analysis is a comparison between treatment groups of the distribution of time to first progressive disease or death.|
1752479|NCT00308087|3220421|Superiority or Other|||||||0.5501|||||||Log Rank|||Log rank analysis is a comparison between treatment groups of the distribution of time to first progressive disease or death.|
1752480|NCT00308087|3220424|Superiority or Other|||||||0.6182||||||"Exact Conditional Test is stratified on the number~> of prior therapies (1 or 2, 3 or more prior therapies)."|2-sided Exact Conditional Test||||
1752481|NCT00307801|3220496|Superiority or Other||||||<|0.0001|||||||inverting 2 one-sided tests||||
1752482|NCT00307684|3220502|Superiority or Other||Mean Difference (Final Values)|2.39||||0.5458||95.0|-5.5469|10.3213|||ANCOVA|treatment and country as factors baseline score as covariate|||
1752483|NCT00307684|3220503|Superiority or Other||Mean Difference (Final Values)|-4.3942||||0.2616||95.0|-12.1928|3.4044||No adjustment for multiplicity was performed.|ANCOVA|ANCOVA on the ranks with sex, treatment and country as factors and age and baseline score as a covariate|||
1752484|NCT00307684|3220506|Superiority or Other||Mean Difference (Final Values)|2.89||||0.2586||95.0|-2.2055|7.9774||No adjustment for multiplicity was performed. threshold for significance: 0.05 (2-sided)|ANCOVA|treatment, sex and country as factors, age and baseline sum of inattention and hyperactivity/impulsivity scores as covariate||Based on preliminary results of a controlled study in adults with MPH, the mean (SD=9) change in CAARS total score from randomization to the 4 week post-randomization endpoint was estimated as +2.5 for PR OROS MPH and +14 for placebo. slightly more conservative, a mean change of 3 in the PR OROS MPH group and a mean increase of 10 in the placebo group were expected. With a two-sided type-I error of 5% and a power of 90%, 37 eligible subjects per group were required.|
1752485|NCT00307489|3220509|Superiority or Other|||||||0.878|||||||Cochran-Mantel-Haenszel||||
1752486|NCT00307489|3220510|Superiority or Other|||||||0.254||||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel||||
1752487|NCT00307489|3220511|Superiority or Other|||||||0.254||||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel||||
1752488|NCT00307489|3220512|Superiority or Other|||||||0.703||||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel||||
1752489|NCT00307489|3220513|Superiority or Other|||||||0.784||||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel||||
1752490|NCT00307489|3220514|Superiority or Other|||||||0.936||||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel||||
1752491|NCT00307489|3220515|Superiority or Other|||||||0.781||||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel||||
1752492|NCT00307489|3220516|Superiority or Other|||||||0.999||||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren||||
1752493|NCT00307489|3220517|Superiority or Other|||||||0.103||||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren||||
1752494|NCT00307489|3220518|Superiority or Other|||||||0.401||||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel||||
1752495|NCT00307489|3220519|Superiority or Other|||||||0.401||||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel||||
1752496|NCT00307489|3220520|Superiority or Other|||||||0.655||||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel||||
1752497|NCT00307489|3220521|Superiority or Other|||||||0.952|||||||Cochran-Mantel-Haenszel|Controlling for baseline HBeAg and prior lamivudine use.|||
1752498|NCT00307489|3220522|Superiority or Other|||||||0.109||||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel||||
1752499|NCT00307489|3220523|Superiority or Other|||||||0.423||||||Controlling for baseline HBeAg status and prior lamivudine use|Cochran-Mantel-Haenszel||||
1752500|NCT00307489|3220524|Superiority or Other|||||||0.988||||||Controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel||||
1752501|NCT00307489|3220525|Superiority or Other|||||||0.712||||||Controlling for baseline HBeAg and prior lamivudine use.|van Elteren||||
1752502|NCT00307489|3220526|Superiority or Other|||||||0.208||||||Controlling for baseline HBeAg status and prior lamivudine use.|van Elteren||||
1752503|NCT00307489|3220527|Superiority or Other|||||||0.544||||||P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use.|Cochran-Mantel-Haenszel||||
1752504|NCT00307437|3220528|Superiority or Other|||||||0.014||||||To control the overall multiplicity, the combined groups was tested first and each dose will then be tested; but the primary and the 1st 2 secondary endpoint analyses need to be significant before this endpoint can be tested.|Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight [less than or equal to 90 kg vs greater than 90 kg)].||Null Hypothesis: No difference between combined q8 group and the combined q12 group, 45 mg q8 and 45 mg q12, 90 mg q8 and 90 mg q12 at an overall significance level of 0.05.|
1752505|NCT00307437|3220528|Superiority or Other|||||||0.21|||||||Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight [less than or equal to 90 kg vs greater than 90 kg)].|||
1752506|NCT00307437|3220528|Superiority or Other|||||||0.468|||||||Cochran-Mantel-Haenszel (row mean score)|Stratified by baseline weight [less than or equal to 90 kg vs greater than 90 kg)].|||
1752507|NCT00307437|3220529|Superiority or Other||||||<|0.001||||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm’s procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first.|ANOVA on van der Waerden normal scores|Analysis of varianceon van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤90 kg vs >90 kg) as factors in the model||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.|
1752508|NCT00307437|3220529|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores|Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 90kg vs > 90 kg) as factors in the model|||
1752509|NCT00307437|3220530|Superiority or Other||||||<|0.001||||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm’s procedure was used but the two comparisons for the primary endpoint need to be significant first.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [less than or equal 90 kg vs greater than 90 kg)].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significancd level of 0.05.|
1752510|NCT00307437|3220530|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [less than or equal 90 kg vs greater than 90 kg)].|||
1752511|NCT00307437|3220531|Superiority or Other||||||<|0.001||||||To control for the multiplicity for the primary endpoint analysis, the Holm’s procedure was used at an overall significance level of 0.05.|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [less than or equal 90 kg vs greater than 90 kg)].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05. Sample Size: With 1200 participants (400 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab groups and placebo using a CMH test stratified by baseline weight [<=90kg vs > 90 kg). For all the scenarios evaluated, the power is >99% at an overall significance level of 0.05.|
1752512|NCT00307437|3220531|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [less than or equal to 90 kg vs greater than 90 kg)].|||
1752513|NCT00307333|3220532|Superiority or Other||Hazard Ratio (HR)|0.78|||||2-Sided|95.0|0.61|0.99|||||HR = hazard for intervention / hazard for control||
1752514|NCT00307333|3220533|Superiority or Other|||||||0.31|||||||t-test, 2 sided||||
1752515|NCT00307333|3220534|Superiority or Other|||||||0.47|||||||t-test, 2 sided||||
1752516|NCT00307333|3220535|Superiority or Other|||||||0.08|||||||t-test, 2 sided||||
1752517|NCT00307164|3220540|Superiority or Other|||||||0.42|||||||Stratified Wilcoxon rank-sum test||||
1752518|NCT00307164|3220541|Superiority or Other|||||||0.8|||||||Stratified Wilcoxon rank-sum test||||
1752521|NCT00307164|3220544|Superiority or Other|||||||0.1|||||||Stratified Wilcoxon rank-sum test||||
1752522|NCT00307164|3220545|Superiority or Other|||||||0.76|||||||Stratified Wilcoxon rank-sum test||||
1752523|NCT00307164|3220546|Superiority or Other|||||||0.034|||||||Stratified Wilcoxon rank-sum test||||
1752524|NCT00307164|3220547|Superiority or Other|||||||0.17|||||||Stratified Wilcoxon rank-sum test||||
1752525|NCT00307164|3220548|Superiority or Other|||||||0.13|||||||Stratified Wilcoxon rank-sum test||||
1752526|NCT00307164|3220549|Superiority or Other|||||||0.6|||||||Stratified Wilcoxon rank-sum test||||
1752527|NCT00307164|3220550|Superiority or Other|||||||0.88|||||||Stratified Wilcoxon rank-sum test||||
1752528|NCT00307164|3220552|Superiority or Other|||||||0.25|||||||Stratified Wilcoxon rank-sum test||||
1752529|NCT00307164|3220554|Superiority or Other|||||||0.17|||||||Log Rank||||
1752530|NCT00307164|3220555|Superiority or Other|||||||0.64|||||||Stratified Wilcoxon rank-sum test|Treatment groups were compared for change in limb fat using a two-sided stratified Wilcoxon rank-sum test (stratified by ARV used)|||
1752531|NCT00307151|3220564|Superiority or Other||Risk Difference (RD)|21.5|||<|0.001|2-Sided|95.0|11.2|31.8||P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.|t-test, 2 sided|Risk difference estimate stratified by age (<12 months vs. >=12 months) and reports rate on NVP arm minus rate on LPV/r arm|Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.||
1752532|NCT00307151|3220564|Superiority or Other||Risk Difference (RD)|18.6|||<|0.015|2-Sided|95.0|3.7|33.6||P-value not adjusted for multiple interim analyses, but adjustment would be negligible because Peto-Haybittle spending function used as basis for calculating repeated confidence intervals used in interim monitoring.|t-test, 2 sided|Risk difference estimate stratified by age (<12 months vs. >=12 months)and reports rate on NVP arm minus rate on LPV/r arm|Endpoint rates with standard errors calculated from Kaplan-Meier curves for each treatment group and age stratum. Differences in week 24 failure proportions by treatment calculated weighted by the inverse of the variance in each age stratum.||
1752533|NCT00307125|3220566|Superiority or Other||||||>|0.999|||||||Fisher Exact||||
1752534|NCT00307125|3220567|Superiority or Other||||||>|0.999|||||||Fisher Exact||||
1752535|NCT00307125|3220572|Superiority or Other||||||>|0.999|||||||Fisher Exact|||Analysis by Fisher’s exact test counting participants with 50% decrease in anti-HLA antibodies at any time within 12 months post treatment initiation|
1752536|NCT00306787|3220719|Non-Inferiority or Equivalence|The estimated power for non-inferiority test (90%) was based on the non-inferiority margin of 1.0 day.|Median Difference (Final Values)|0.16|||||2-Sided|95.0|-0.15|0.6||||||Difference in time to healing= time to healing for famciclovir- time to healing for valacyclovir.|
1752537|NCT00306293|3220749|Superiority or Other||Percent change from Baseline|-77.0||||0.014||95.0|||||Wilcoxon Rank Sum||Percent change in ‘percentage of days with clinical HSV-2 viral shedding', after VALTREX 1g treatment from the placebo||
1752538|NCT00306293|3220750|Superiority or Other||Percent change from Placebo|-78.0|||<|0.001||95.0|||||Wilcoxon Rank Sum Test||Percent change in days with Subclinical HSV-2 Viral Shedding after VALTREX 1g treatment from the placebo||
1752539|NCT00306189|3220801|Superiority or Other||Mean Difference (Final Values)|6.27|||<|0.0001||95.0|5.06|7.49|||t-test, 2 sided||||
1752540|NCT00306189|3220801|Superiority or Other||Mean Difference (Final Values)|5.25|||<|0.0001||95.0|4.1|6.4|||t-test, 2 sided||||
1752541|NCT00306189|3220801|Superiority or Other||Mean Difference (Final Values)|7.0|||<|0.0001||95.0|5.76|8.24|||t-test, 2 sided||||
1752542|NCT00305864|3220812|Superiority or Other|||||||0.27|||||||Log Rank|One-sided||A one-sided one-sample log-rank test at significance level of 0.10 was predicted to have 85% power to detect a survival difference against the historical control (13.7 vs. 18.5 months) with 60 deaths.|
1752543|NCT00305604|3220826|Superiority or Other||Mean Difference (Net)|-23.5|Standard Deviation|25.2|<|0.001||95.0|-32.6|-14.4|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (< 75/>= 75 yr); baseline creatinine clearance (< 50/>= 50 mL/min)|||
1752544|NCT00305604|3220827|Superiority or Other||Mean Difference (Net)|-61.0|Standard Deviation|63.0|<|0.001||95.0|-82.1|-40.0|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (< 75/>= 75 yr); baseline creatinine clearance (< 50/>= 50 mL/min)|||
1752545|NCT00305604|3220828|Superiority or Other||Mean Difference (Net)|-26.8|Standard Deviation|45.0|<|0.001||95.0|-40.0|-13.5|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (< 75/>= 75 yr); baseline creatinine clearance (< 50/>= 50 mL/min)|||
1752546|NCT00305604|3220829|Superiority or Other||Mean Difference (Net)|-0.7|Standard Deviation|0.81|<|0.001||95.0|-0.94|-0.47|||ANCOVA|Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (< 75/>= 75 yr); baseline creatinine clearance (< 50/>= 50 mL/min)|||
1752547|NCT00305565|3220868|Superiority or Other||Mean Difference (Net)|0.33||||0.813|2-Sided|95.0|-2.39|3.05|||Mixed Models Analysis|||The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.|
1752548|NCT00305565|3220868|Superiority or Other||Mean Difference (Net)|0.34||||0.803|2-Sided|95.0|-2.34|3.02|||Mixed Models Analysis|||The primary analysis consisted of contrasts comparing High Dose vs. Low Dose and Medium Dose vs. Low Dose averaged over the 4 Acute Phase visits using the Hochberg approach to adjust for multiplicity. If both comparisons involving the Low Dose were significant, then a test of High Dose vs. Medium Dose was evaluated at the P≤0.05 level. The pivotal analysis was performed on the ITT population using the last-observation-carried-forward (LOCF) approach to impute missing data.|
1752549|NCT00305344|3220875|Superiority or Other||||||>|0.05|||||||Fisher Exact|||Null hypothesis: there will be no difference between AUC C-peptide at baseline and 1 or 2 years post cord blood infusion|
1752550|NCT00305253|3220876|Superiority or Other||Risk Ratio (RR)|0.41|||<|0.05|2-Sided|95.0|0.21|0.8|||t-test, 2 sided||Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|Relative risks and confidence intervals were computed for emergency hysterectomy.|
1752551|NCT00305253|3220877|Superiority or Other||Mean Difference (Final Values)|7.79|||<|0.0001|2-Sided|95.0|||||t-test, 2 sided||Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|Mean measured volume of blood loss in the drape was compared across phases with t-tests.|
1752552|NCT00305253|3220878|Superiority or Other||Odds Ratio (OR)|0.38||||0.019|2-Sided|95.0|0.17|0.85|||Regression, Logistic|Independent variables were selected on the basis of their significant association with EAO in bivariate analyses (t-tests and logistic regression).|Pre-Intervention group was compared to the Post-Intervention group. Each group contained different study participants.|"Relative risks and confidence intervals were computed for the primary outcome, Extreme Adverse Outcomes (EAO) - a combined measure of maternal mortality or severe mobidity.~To estimate the independent effect of the intervention net of the effects of other baseline characteristics, a multiple logistic regression model was used."|
1752553|NCT00305084|3220913|Other||MDT|1.6|||||2-Sided|||||||||All data regarding safety were registered and analyzed by descriptive analyses. Summary table were generated to document the safety|at least 3 patients per cohort had to be enrolled with expansion to 6 in presence of Dose Limiting Toxicity(DLT) (stop escalation if 2 or more DLTs at the same dose level). With a projection to achieve the highest level of NGR-hTNF, without significative toxicity (1.6 μg/m2) a planned sample of 20-25 patients was expected. DLTs were defined as: any severe toxicity clearly related to the administration of NGR-hTNF. The patient was defined assessable, according to the standard analysis, if he/she received at least one infusion of the investigational product. Maximal Tollerated Dose (MTD) was defined as the dose which produces DLTs in 2 or more patients out of 6 and will be recommended for phase II trials.
1752554|NCT00304915|3220921|Superiority or Other||Odds Ratio (OR)|2.5||||0.003|2-Sided|95.0|1.37|4.56|||Regression, Logistic||||
1752555|NCT00304746|3220922|Superiority or Other|||||||0.71||||||For a complete presentation of the above analysis, please see the published paper presenting the full results of this study.|mixed effects linear regression analysis|||Our primary analysis of efficacy was a mixed effects linear regression analysis comparing the rate of change of score on the HAM-D during the blinded treatment phase between groups. Our model for the mean of the outcome variable included terms for treatment, time (modeled as a continuous variable), and treatment-by-time. The measure of effect was the treatment-by-time interaction, which can be interpreted as the difference in slope with respect to time, of the outcome measure.|
1752556|NCT00304187|3220933|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1752557|NCT00304070|3220952|Other||2 Year EFS|0.55||||8.53e-06|2-Sided|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 15% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.|
1752558|NCT00304070|3220952|Other||2 Year EFS|0.53||||0.4|2-Sided|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 50% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.|
1752559|NCT00304070|3220952|Other||2 Year EFS|0.89||||0.44|2-Sided|95.0|||||2-year KM estimate|||We will test the 2-year EFS is 90% using the asymptotic distribution of the complementary log-log distribution of the Kaplan-Meier (KM) estimate.|
1752560|NCT00304031|3220959|Superiority or Other||Hazard Ratio (HR)|1.03||||0.63|2-Sided|95.0|0.88|1.2||One-sided|Log Rank||Hazard ratio: denominator = conventional arm, numerator = dose-dense arm.|This study was looking for a 20% reduction in hazard rate: null hypothesis (conventional arm): MST (median survival time) = 14.0 mo.; alternative hypothesis (dose-dense arm): MST= 17.5 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 750 patients (647 deaths were required for the final analysis).|
1752561|NCT00303979|3220960|Superiority or Other||Mean Relative Change (%)|10.6|||<|0.001|2-Sided|95.0|7.6|13.6|||t-test, 2 sided|||Composite Score: the relative change of Cohort C (18 months) compared with Cohort A at baseline in composite score for the aggregate practices.|
1752562|NCT00303979|3220960|Superiority or Other||Mean Relative Change (%)|59.5|||<|0.001|2-Sided|95.0|33.9|85.2|||t-test, 2 sided|||Performance Measure #7: the relative change of Cohort C (18 months) compared with Cohort A at baseline in HF education for the aggregate practices.|
1752563|NCT00303979|3220960|Superiority or Other||Mean Relative Change (%)|17.6|||<|0.001|2-Sided|95.0|9.3|25.8|||t-test, 2 sided|||Performance Measure #6: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.|
1752564|NCT00303979|3220960|Superiority or Other||Mean Relative Change (%)|9.3|||<|0.085|2-Sided|95.0|-1.3|19.8|||t-test, 2 sided|||Performance Measure #5: the relative change of Cohort C (18 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.|
1752565|NCT00303979|3220960|Superiority or Other||Mean Relative Change (%)|6.7|||<|0.033|2-Sided|95.0|0.5|13.0|||t-test, 2 sided|||Performance Measure #4: the relative change of Cohort C (18 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.|
1752566|NCT00303979|3220960|Superiority or Other||Mean Relative Change (%)|5.8|||<|0.24|2-Sided|95.0|-3.9|15.4|||t-test, 2 sided|||Performance Measure #3: the relative change of Cohort C (18 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.|
1752567|NCT00303979|3220960|Superiority or Other||Mean Relative Change (%)|14.3|||<|0.048|2-Sided|95.0|0.1|28.4|||t-test, 2 sided|||Performance Measure #2: the relative change of Cohort C (18 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.|
1752568|NCT00303979|3220960|Superiority or Other||Mean Relative Change (%)|10.5|||<|0.19|2-Sided|95.0|-5.3|26.3|||t-test, 2 sided|||Performance Measure #1: the relative change of Cohort C (18 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.|
1752569|NCT00303979|3220961|Superiority or Other||Mean Relative Change (%)|6.6|||<|0.001|2-Sided|95.0|4.2|9.0|||t-test, 2 sided|||Composite Score: the relative change of Cohort B (6 months) compared with Cohort A at baseline in composite score for the aggregate practices.|
1752637|NCT00303446|3221071|Superiority or Other|||||||0.08|||||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.|||
1752570|NCT00303979|3220961|Superiority or Other||Mean Relative Change (%)|38.5|||<|0.001|2-Sided|95.0|23.2|53.8|||t-test, 2 sided|||Performance Measure #7: the relative change of Cohort B (6 months) compared with Cohort A at baseline in HF education for the aggregate practices.|
1752571|NCT00303979|3220961|Superiority or Other||Mean Relative Change (%)|14.4|||<|0.001|2-Sided|95.0|6.9|22.0|||t-test, 2 sided|||Performance Measure #6: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ICD/CRT-D for the aggregate practices.|
1752572|NCT00303979|3220961|Superiority or Other||Mean Relative Change (%)|-1.8|||<|0.711|2-Sided|95.0|-11.2|7.7|||t-test, 2 sided|||Performance Measure #5: the relative change of Cohort B (6 months) compared with Cohort A at baseline in CRT-P/CRT-D for the aggregate practices.|
1752573|NCT00303979|3220961|Superiority or Other||Mean Relative Change (%)|6.2|||<|0.05|2-Sided|95.0|0.0|12.4|||t-test, 2 sided|||Performance Measure #4: the relative change of Cohort B (6 months) compared with Cohort A at baseline in anticoagulation for AF for the aggregate practices.|
1752574|NCT00303979|3220961|Superiority or Other||Mean Relative Change (%)|-1.1|||<|0.622|2-Sided|95.0|-5.7|3.4|||t-test, 2 sided|||Performance Measure #3: the relative change of Cohort B (6 months) compared with Cohort A at baseline in aldosterone antagonist for the aggregate practices.|
1752575|NCT00303979|3220961|Superiority or Other||Mean Relative Change (%)|10.6|||<|0.061|2-Sided|95.0|-0.5|21.7|||t-test, 2 sided|||Performance Measure #2: the relative change of Cohort B (6 months) compared with Cohort A at baseline in beta-blockers for the aggregate practices.|
1752576|NCT00303979|3220961|Superiority or Other||Mean Relative Change (%)|10.3|||<|0.197|2-Sided|95.0|-5.4|25.9|||t-test, 2 sided|||Performance Measure #1: the relative change of Cohort B (6 months) compared with Cohort A at baseline in ACEI/ARB for the aggregate practices.|
1752577|NCT00303979|3220962|Superiority or Other||Mean Relative Change (%)|19.2|||<|0.001|2-Sided|95.0|16.3|22.0|||t-test, 2 sided|||Composite Score: The relative change at 24 months compared with baseline in composite score for the aggregate practices.|
1752578|NCT00303979|3220962|Superiority or Other||Mean Relative Change (%)|50.6|||<|0.001|2-Sided|95.0|27.1|74.2|||t-test, 2 sided|||Performance Measure #7: the relative change at 24 months compared with baseline in HF education for the aggregate practices.|
1752579|NCT00303979|3220962|Superiority or Other||Mean Relative Change (%)|70.9|||<|0.001|2-Sided|95.0|61.0|80.8|||t-test, 2 sided|||Performance Measure #6: the relative change at 24 months compared with baseline in ICD/CRT-D for the aggregate practices.|
1752580|NCT00303979|3220962|Superiority or Other||Mean Relative Change (%)|48.4|||<|0.001|2-Sided|95.0|37.9|58.8|||t-test, 2 sided|||Performance Measure #5: the relative change at 24 months compared with baseline in CRT-P/CRT-D for the aggregate practices.|
1752581|NCT00303979|3220962|Superiority or Other||Mean Relative Change (%)|1.0|||<|0.513||95.0|-3.6|5.5|||t-test, 2 sided|||Performance Measure #4: the relative change at 24 months compared with baseline in anticoagulation for AF for the aggregate practices.|
1752582|NCT00303979|3220962|Superiority or Other||Mean Relative Change (%)|30.0|||<|0.001|2-Sided|95.0|24.6|35.5|||t-test, 2 sided|||Performance Measure #3: the relative change at 24 months compared with baseline in aldosterone antagonist for the aggregate practices.|
1752583|NCT00303979|3220962|Superiority or Other||Mean Relative Change (%)|7.6|||<|0.001|2-Sided|95.0|5.1|10.2|||t-test, 2 sided|||Performance Measure #2: the relative change at 24 months compared with baseline in beta-blockers for the aggregate practices.|
1752584|NCT00303979|3220962|Superiority or Other||Mean Relative Change (%)|19.4|||<|0.004|2-Sided|95.0|-1.1|39.8|||t-test, 2 sided|||Performance Measure #1: Relative change at 24 months compared with baseline in ACEI/ARB for the aggregate practices.|
1752585|NCT00303979|3220964|Superiority or Other||Relative Improvement (%)|14.7|||<|0.001|2-Sided|95.0|12.6|16.8|||a large sample test (z-test)|||Performance Measure #7: relative change in % of eligible patients with HF education.|
1752586|NCT00303979|3220964|Superiority or Other||Relative Improvement (%)|62.1|||<|0.001|2-Sided|95.0|59.1|65.1|||a large sample test (z-test)|||Performance Measure #6: relative change in % of eligible patients treated with implantable cardioverter-defibrillator (ICD) or CRT-D.|
1752587|NCT00303979|3220964|Superiority or Other||Relative Improvement (%)|81.9|||<|0.001|2-Sided|95.0|72.2|91.7|||a large sample test (z-test)|||Performance Measure #5: relative change in % of eligible patients treated with cardiac resynchronization therapy (CRT-P/CRT-D).|
1752588|NCT00303979|3220964|Superiority or Other||Relative Improvement (%)|1.0|||<|0.546|2-Sided|95.0|-2.2|4.2|||a large sample test (z-test)|||Performance Measure #4: relative change in % of eligible patients treated with anticoagulation for AF.|
1752589|NCT00303979|3220964|Superiority or Other||Relative improvement (%)|79.7|||<|0.001|2-Sided|95.0|70.5|89.0|||a large sample test (z-test)|||Performance Measure #3: relative change in % of eligible patients treated with aldosterone receptor antagonists.|
1752590|NCT00303979|3220964|Superiority or Other||Relative improvement (%)|8.6|||<|0.001|2-Sided|95.0|7.7|9.6|||a large sample test (z-test)|||Performance Measure #2: relative change in % of eligible patients treated with beta-blockers.|
1752591|NCT00303979|3220964|Superiority or Other||Relative Improvement (%)|8.4|||<|0.001|2-Sided|95.0|7.0|9.7|||a large sample test (z-test)|||Performance Measure #1: relative change in % of eligible patients treated with angiotensin converting enzyme inhibitor and/or angiotensin II receptor blockers (ACEU/ARB).|
1752592|NCT00303628|3221005|Superiority or Other|||||||0.299||||||two-sided stratified log rank test p value|Log Rank||||
1752593|NCT00303628|3221006|Superiority or Other|||||||0.876||||||Stratified log rank test. The above P value was for one-sided test|Log Rank||||
1752594|NCT00303602|3221007|Superiority or Other|||||||0.229|||||||Mixed Models Analysis||||
1752595|NCT00303602|3221008|Superiority or Other|||||||0.161|||||||Mixed Models Analysis||||
1752596|NCT00303602|3221009|Superiority or Other|||||||0.118|||||||Mixed Models Analysis||||
1752597|NCT00303602|3221010|Superiority or Other|||||||0.515||||||Endpoint Metabolic Syndrome p-value|Fisher Exact||||
1752598|NCT00303602|3221011|Superiority or Other|||||||0.022|||||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals on this regression in CMH test.|||
1753459|NCT00289198|3222965|Superiority or Other||Mean Difference (Final Values)|-0.496||||0.005|2-Sided|95.0|-0.84|-0.15|||ANCOVA||||
1752599|NCT00303602|3221012|Superiority or Other|||||||0.834|||||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.|||
1752600|NCT00303602|3221013|Superiority or Other|||||||0.02|||||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.|||
1752601|NCT00303602|3221014|Superiority or Other|||||||0.227|||||||Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.|||
1752602|NCT00303602|3221015|Superiority or Other|||||||0.581||||||Triglycerides Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.|||
1752603|NCT00303602|3221015|Superiority or Other|||||||0.323||||||Low-Density Lipoprotein Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.|||
1752604|NCT00303602|3221015|Superiority or Other|||||||0.163||||||High-Density Lipoprotein Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.|||
1752605|NCT00303602|3221015|Superiority or Other|||||||0.187||||||Total Cholesterol Change to Endpoint p-value|Cochran-Mantel-Haenszel|Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.|||
1752606|NCT00303602|3221016|Superiority or Other|||||||0.453||||||Diastolic Blood Pressure Change to Endpoint p-value|Rank-Sum Test||||
1752607|NCT00303602|3221016|Superiority or Other|||||||0.708||||||Systolic Blood Pressure Change to Endpoint p-value|Rank-Sum Test||||
1752608|NCT00303602|3221017|Superiority or Other|||||||0.344|||||||Mixed Models Analysis||||
1752609|NCT00303602|3221019|Superiority or Other|||||||0.325||||||Up to Week 16 p-value|Fisher Exact||||
1752610|NCT00303602|3221020|Superiority or Other||Least Square Mean Change Difference|0.1||||0.914||95.0|-1.65|1.84|||ANCOVA||Change = endpoint minus baseline||
1752611|NCT00303602|3221021|Superiority or Other|||||||0.385|||||||Mixed Models Analysis||||
1752612|NCT00303602|3221022|Superiority or Other||Least Square Mean Change Difference|-0.32||||0.328||95.0|-0.95|0.32|||ANCOVA||Change = Endpoint minus baseline||
1752613|NCT00303602|3221023|Superiority or Other||Least Square Mean Change Difference|-0.19||||0.442||95.0|-0.67|0.3|||ANCOVA||Change = Endpoint minus baseline||
1752614|NCT00303602|3221024|Superiority or Other|||||||0.465||||||P-value for Week 16 Change from Baseline. There was no adjustment for multiple comparisons|Mixed Models Analysis||||
1752615|NCT00303602|3221024|Superiority or Other|||||||0.784||||||P-value for Week 12 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis||||
1752616|NCT00303602|3221024|Superiority or Other|||||||0.885||||||P-value for Week 8 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis||||
1752617|NCT00303602|3221024|Superiority or Other|||||||0.859||||||P-value for Week 4 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis||||
1752618|NCT00303602|3221024|Superiority or Other|||||||0.428||||||P-value for Week 2 Change from Baseline. There was no adjustment for multiple comparisons.|Mixed Models Analysis||||
1752619|NCT00303485|3221035|Superiority or Other||Difference in median|-64.2|||<|0.0001|2-Sided|95.0|-80.28|-46.21|||Wilcoxon rank sum test||||
1752620|NCT00303459|3221054|Superiority or Other||Mean Difference (Net)|0.2||||0.4086|2-Sided|95.0|-3.7|4.0|||Wilcoxon (Mann-Whitney)||||
1752621|NCT00303459|3221055|Superiority or Other||Mean Difference (Net)|0.02||||0.5571|2-Sided|95.0|-0.036|0.076|||Wilcoxon (Mann-Whitney)||||
1752622|NCT00303459|3221056|Superiority or Other||Mean Difference (Net)|-0.01||||0.9566|2-Sided|95.0|-0.42|0.39|||Wilcoxon (Mann-Whitney)||||
1752623|NCT00303459|3221057|Superiority or Other||Percentage change over placebo|-23.52||||0.0003|2-Sided|95.0|-33.69|-11.79|||Repeated measures analysis||||
1752624|NCT00303459|3221058|Superiority or Other||Hazard Ratio (HR)|0.855||||0.4974|2-Sided|95.0|0.544|1.344|||Log Rank||||
1752625|NCT00303459|3221059|Superiority or Other||Relative risk of improvement|0.98||||1|2-Sided|95.0|0.6|1.61|||Fisher Exact||||
1752626|NCT00303459|3221060|Superiority or Other||Mean Difference (Net)|21.8||||0.0106|2-Sided|95.0|5.9|37.8|||Wilcoxon (Mann-Whitney)||||
1752627|NCT00303459|3221061|Superiority or Other||Hazard Ratio (HR)|0.963||||0.8385|2-Sided|95.0|0.673|1.38|||Log Rank||||
1752628|NCT00303459|3221062|Superiority or Other||Hazard Ratio (HR)|0.831||||0.2508|2-Sided|97.31|0.582|1.187|||Log Rank||||
1752629|NCT00303446|3221063|Superiority or Other|||||||0.61|||||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.|||
1752630|NCT00303446|3221064|Superiority or Other|||||||0.033||||||Generalized estimating equation model showed a significant interaction between time and treatment; therefore a two sample t-test was used at each time point. P-value is given for comparison at 24 months.|t-test, 2 sided||||
1752631|NCT00303446|3221065|Superiority or Other|||||||0.014|||||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.|||
1752632|NCT00303446|3221066|Superiority or Other|||||||1|||||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.|||
1752633|NCT00303446|3221067|Superiority or Other|||||||0.99|||||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.|||
1752634|NCT00303446|3221068|Superiority or Other|||||||0.65|||||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.|||
1752635|NCT00303446|3221069|Superiority or Other|||||||0.37|||||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.|||
1752636|NCT00303446|3221070|Superiority or Other|||||||0.73|||||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.|||
1753460|NCT00289198|3222966|Superiority or Other||Mean Difference (Final Values)|-0.531||||0.003|2-Sided|95.0|-0.88|-0.19|||ANCOVA||||
1752638|NCT00303446|3221072|Superiority or Other|||||||0.11|||||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.|||
1752639|NCT00303446|3221073|Superiority or Other|||||||0.46|||||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.|||
1752640|NCT00303446|3221074|Superiority or Other|||||||0.13|||||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.|||
1752641|NCT00303446|3221075|Superiority or Other|||||||0.47|||||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.||Comparison of changes from baseline in manual muscle testing results.|
1752642|NCT00303446|3221076|Superiority or Other|||||||0.86|||||||Generalized estimating equation model|The analysis includes change from baseline at 12 and 24 months.|||
1752643|NCT00303446|3221077|Superiority or Other|||||||0.28|||||||Generalized estimating equation model|The analysis includes percent change from baseline at 12 and 24 months.|||
1752644|NCT00303186|3221086|Superiority or Other||Mean Difference (Final Values)|-5.7|Standard Deviation|12.8||0.002|2-Sided|95.0|-9.23|-2.18|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: mental component score and Month 60: mental component score.|
1752645|NCT00303186|3221086|Superiority or Other||Mean Difference (Final Values)|-5.59|Standard Deviation|12.29||0.003|2-Sided|95.0|-9.12|-2.06|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: mental component score and Month 60: mental component score.|
1752646|NCT00303186|3221086|Superiority or Other||Mean Difference (Final Values)|-0.67|Standard Deviation|8.51||0.589|2-Sided|95.0|-3.14|1.8|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: mental component score and Month 12: mental component score.|
1752647|NCT00303186|3221086|Superiority or Other||Mean Difference (Final Values)|1.25|Standard Deviation|8.83||0.308|2-Sided|95.0|-1.19|3.68|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: physical component score and Month 60: physical component score.|
1752648|NCT00303186|3221086|Superiority or Other||Mean Difference (Final Values)|-5.94|Standard Deviation|9.13|<|0.0001|2-Sided|95.0|-8.56|-3.32|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: physical component score and Month 60: physical component score.|
1752649|NCT00303186|3221086|Superiority or Other||Mean Difference (Final Values)|-7.41|Standard Deviation|10.1|<|0.0001|2-Sided|95.0|-10.34|-4.47|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: physical component score and Month 12: physical component score.|
1752650|NCT00303186|3221087|Superiority or Other||Mean Difference (Final Values)|4.85|Standard Deviation|22.22||0.115|2-Sided|95.0|-1.21|10.92|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.|
1752651|NCT00303186|3221087|Superiority or Other||Mean Difference (Final Values)|-12.68|Standard Deviation|22.08||0.0001|2-Sided|95.0|-18.77|-6.59|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752652|NCT00303186|3221087|Superiority or Other||Mean Difference (Final Values)|19.4|Standard Deviation|25.0|<|0.0001|2-Sided|95.0|14.59|24.22|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.|
1752653|NCT00303186|3221088|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Deviation|0.27||0.789|2-Sided|95.0|-0.08|0.06|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.|
1752654|NCT00303186|3221088|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Deviation|0.34|<|0.0001|2-Sided|95.0|-0.31|-0.12|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752655|NCT00303186|3221088|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Deviation|0.31|<|0.0001|2-Sided|95.0|0.18|0.3|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.|
1752656|NCT00303186|3221089|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Deviation|0.61||0.6|2-Sided|95.0|-0.24|0.14|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.|
1752657|NCT00303186|3221089|Superiority or Other||Mean Difference (Final Values)|0.41|Standard Deviation|0.56|<|0.0001|2-Sided|95.0|0.26|0.56|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752658|NCT00303186|3221089|Superiority or Other||Mean Difference (Final Values)|0.48|Standard Deviation|0.66|<|0.0001|2-Sided|95.0|0.35|0.62|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.|
1752659|NCT00303186|3221091|Superiority or Other||Mean Difference (Final Values)|33.4|Standard Deviation|147.25||0.034|2-Sided|95.0|-10.84|77.64|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Month 12 and Month 60.|
1752660|NCT00303186|3221091|Superiority or Other||Mean Difference (Final Values)|52.81|Standard Deviation|100.25|<|0.0001|2-Sided|95.0|22.33|83.29|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752661|NCT00303186|3221091|Superiority or Other||Mean Difference (Final Values)|16.26|Standard Deviation|150.1|<|0.0005|2-Sided|95.0|-13.52|46.04|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 12.|
1752662|NCT00303186|3221092|Superiority or Other||Mean Difference (Final Values)|-2.31|Standard Deviation|14.07||0.132|2-Sided|95.0|-6.4|1.77|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Month 12 and Month 60.|
1752663|NCT00303186|3221092|Superiority or Other||Mean Difference (Final Values)|13.19|Standard Deviation|18.3|<|0.0001|2-Sided|95.0|7.81|18.57|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752664|NCT00303186|3221092|Superiority or Other||Mean Difference (Final Values)|26.21|Standard Deviation|123.2|<|0.0001|2-Sided|95.0|2.01|50.4|||Wilcoxon (Mann-Whitney)|||Statistical analysis was carried out between categories, Baseline and Month 12.|
1752665|NCT00303186|3221093|Superiority or Other||Mean Difference (Final Values)|-3.33|Standard Deviation|22.77||0.301|2-Sided|95.0|-9.74|3.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.|
1752666|NCT00303186|3221093|Superiority or Other||Mean Difference (Final Values)|28.8|Standard Deviation|25.89|<|0.0001|2-Sided|95.0|21.52|36.09|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752667|NCT00303186|3221093|Superiority or Other||Mean Difference (Final Values)|31.18|Standard Deviation|27.56|<|0.0001|2-Sided|95.0|25.88|36.49|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.|
1752668|NCT00303186|3221094|Superiority or Other||Mean Difference (Final Values)|2.38|Standard Deviation|17.59||0.343|2-Sided|95.0|-2.62|7.38|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.|
1752669|NCT00303186|3221094|Superiority or Other||Mean Difference (Final Values)|38.04|Standard Deviation|21.17|<|0.0001|2-Sided|95.0|31.96|44.12|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752670|NCT00303186|3221094|Superiority or Other||Mean Difference (Final Values)|33.83|Standard Deviation|19.6|<|0.0001|2-Sided|95.0|30.04|37.63|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.|
1752671|NCT00303186|3221095|Superiority or Other||Mean Difference (Final Values)|-2.05|Standard Deviation|24.6||0.538|2-Sided|95.0|-8.7|4.6|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.|
1752672|NCT00303186|3221095|Superiority or Other||Mean Difference (Final Values)|28.76|Standard Deviation|23.24|<|0.0001|2-Sided|95.0|22.42|35.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752673|NCT00303186|3221095|Superiority or Other||Mean Difference (Final Values)|31.18|Standard Deviation|24.48|<|0.0001|2-Sided|95.0|26.44|35.91|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.|
1752674|NCT00303186|3221096|Superiority or Other||Mean Difference (Final Values)|-15.0|Standard Deviation|38.17||0.165|2-Sided|95.0|-37.04|7.04|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.|
1752675|NCT00303186|3221096|Superiority or Other||Mean Difference (Final Values)|-8.56|Standard Deviation|32.28||0.449|2-Sided|95.0|-33.37|16.26|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752676|NCT00303186|3221096|Superiority or Other||Mean Difference (Final Values)|1.26|Standard Deviation|11.29||0.33|2-Sided|95.0|-1.3|3.82|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.|
1752677|NCT00303186|3221100|Superiority or Other||Mean Difference (Final Values)|0.66|Standard Deviation|8.92||0.588|2-Sided|95.0|-1.76|3.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: tender joints and Month 60: tender joints.|
1752678|NCT00303186|3221100|Superiority or Other||Mean Difference (Final Values)|8.6|Standard Deviation|9.25|<|0.0001|2-Sided|95.0|6.1|11.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: tender joints and Month 60: tender joints.|
1752679|NCT00303186|3221100|Superiority or Other||Mean Difference (Final Values)|9.0|Standard Deviation|11.16|<|0.0001|2-Sided|95.0|6.86|11.13|||t-test, 1 sided|||Statistical analysis was carried out between categories, Baseline: tender joints and Month 12: tender joints.|
1752680|NCT00303186|3221100|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Deviation|2.09|<|0.479|2-Sided|95.0|-0.36|0.76|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12: swollen joints and Month 60: swollen joints.|
1752681|NCT00303186|3221100|Superiority or Other||Mean Difference (Final Values)|6.2|Standard Deviation|6.35|<|0.0001|2-Sided|95.0|4.48|7.92|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: swollen joints and Month 60: swollen joints.|
1752682|NCT00303186|3221100|Superiority or Other||Mean Difference (Final Values)|6.33|Standard Deviation|5.94|<|0.0001|2-Sided|95.0|5.1|7.47|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline: swollen joints and Month 12: swollen joints.|
1752683|NCT00303186|3221101|Superiority or Other||Mean Difference (Final Values)|0.56|Standard Deviation|3.32||0.223|2-Sided|95.0|-0.35|1.46|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.|
1752684|NCT00303186|3221101|Superiority or Other||Mean Difference (Final Values)|2.0|Standard Deviation|3.64|<|0.001|2-Sided|95.0|1.01|2.99|||t-test, 1 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752685|NCT00303186|3221101|Superiority or Other||Mean Difference (Final Values)|1.486|Standard Deviation|2.96|<|0.0001|2-Sided|95.0|0.918|2.05|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.|
1752686|NCT00303186|3221102|Superiority or Other||Mean Difference (Final Values)|0.44|Standard Deviation|7.41||0.676|2-Sided|95.0|-1.666|2.546|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752687|NCT00303186|3221103|Superiority or Other||Mean Difference (Final Values)|-6.76|Standard Deviation|18.8||0.015|2-Sided|95.0|-12.155|-1.355|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752688|NCT00303186|3221104|Superiority or Other||Mean Difference (Final Values)|1.66|Standard Deviation|11.75||0.004|2-Sided|95.0|1.619|8.301|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752689|NCT00303186|3221106|Superiority or Other||Mean Difference (Final Values)|-0.28|Standard Deviation|2.03||0.309|2-Sided|95.0|-0.83|0.27|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.|
1752690|NCT00303186|3221106|Superiority or Other||Mean Difference (Final Values)|2.23|Standard Deviation|2.36|<|0.0001|2-Sided|95.0|1.59|2.87|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752691|NCT00303186|3221106|Superiority or Other||Mean Difference (Final Values)|2.72|Standard Deviation|2.39|<|0.0001|2-Sided|95.0|2.26|3.18|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.|
1752692|NCT00303186|3221107|Superiority or Other||Mean Difference (Final Values)|-0.55|Standard Deviation|18.7||0.833|2-Sided|95.0|-5.7|4.61|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.|
1752693|NCT00303186|3221107|Superiority or Other||Mean Difference (Final Values)|12.6|Standard Deviation|20.36|<|0.0001|2-Sided|95.0|6.99|18.21|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752694|NCT00303186|3221107|Superiority or Other||Mean Difference (Final Values)|17.72|Standard Deviation|27.89|<|0.0001|2-Sided|95.0|12.38|23.07|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.|
1753021|NCT00295022|3222036|Superiority or Other||Mean Difference (Final Values)|-3.12|||<|0.001|2-Sided|95.0|-4.35|-1.88|||ANCOVA||||
1752695|NCT00303186|3221108|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Deviation|4.1||0.518|2-Sided|95.0|-1.5|0.76|||t-test, 2 sided|||Statistical analysis was carried out between categories, Month 12 and Month 60.|
1752696|NCT00303186|3221108|Superiority or Other||Mean Difference (Final Values)|3.72|Standard Deviation|7.47|<|0.001|2-Sided|95.0|1.65|5.78|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 60.|
1752697|NCT00303186|3221108|Superiority or Other||Mean Difference (Final Values)|3.75|Standard Deviation|7.03|<|0.0001|2-Sided|95.0|2.4|5.1|||t-test, 2 sided|||Statistical analysis was carried out between categories, Baseline and Month 12.|
1752698|NCT00303069|3221118|Superiority or Other||Risk Difference (RD)|3.5|||<|0.001|2-Sided|95.0|-8.2|16.9||P-value < 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (<40 yrs, ≥40 yrs)|Risk Difference is 5 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.|
1752699|NCT00303069|3221118|Superiority or Other||Risk Difference (RD)|14.4|||<|0.001|2-Sided|95.0|1.6|32.1||P-value < 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (<40 yrs, ≥40 yrs)|Risk Difference is 30 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.|
1752700|NCT00303069|3221118|Superiority or Other||Risk Difference (RD)|30.9|||<|0.001|2-Sided|95.0|17.2|48.3||P-value < 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (<40 yrs, ≥40 yrs)|Risk Difference is 90 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.|
1752701|NCT00303069|3221119|Superiority or Other||Risk Difference (RD)|25.0|||<|0.001|2-Sided|95.0|6.7|43.8||P-value < 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (<40 yrs, ≥40 yrs)|Risk Difference is 5 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.|
1752702|NCT00303069|3221119|Superiority or Other||Risk Difference (RD)|81.6|||<|0.01|2-Sided|95.0|61.6|92.0||P-value < 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (<40 yrs, ≥40 yrs)|Risk Difference is 30 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.|
1752703|NCT00303069|3221119|Superiority or Other||Risk Difference (RD)|84.5|||<|0.001|2-Sided|95.0|65.2|93.6||P-value < 0.025 considered significant.|Chi-squared|Normal approximation for testing 2 independent binomial proportions, stratified by age group (<40 yrs, ≥40 yrs)|Risk Difference is 90 μg minus Placebo and is expressed in percentage points, confidence intervals were computed using the stratified method given by Miettinen and Nurminen|Testing was performed in a sequential manner. First, the response rate of the 90-μg group was compared to placebo and assessed for significance (using a 1-tailed α=0.025). If significant, the response rate of the 30-μg group was compared to placebo and assessed for significance. The testing continued sequentially until a non-significant result was observed or until all V710 groups had been compared with placebo.|
1752704|NCT00302952|3221130|Superiority or Other (legacy)|||||||0.35||||||Adjustments were made for baseline serum anti-CCP by ELISA|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group.|
1752705|NCT00302952|3221131|Superiority or Other (legacy)|||||||0.19||||||Adjustments were made for baseline serum IgM RF by ELISA test result. In the ANCOVA model, baseline value was a covariate; therefore, an adjustment was performed.|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group.|
1752706|NCT00302952|3221132|Superiority or Other (legacy)||Difference in Percentage|-11.0||||0.39|2-Sided|95.0|-35.9|14.0|||Chi-squared||The difference in percentages is calculated as Lovastatin – Placebo.|The p-value compares Lovastatin with the Placebo treatment group.|
1752707|NCT00302952|3221133|Superiority or Other (legacy)|||||||0.91||||||Adjustments were made for baseline DAS28-CRP score.|ANCOVA|ANOVA was performed on participants with a DAS28-CRP score at Day 84.||The p-value compares Lovastatin with the Placebo treatment group.|
1752708|NCT00302952|3221135|Superiority or Other (legacy)|||||||0.79||||||Adjustments were made for baseline ln(CRP), baseline DAS28-CRP score, race, methotrexate use, anti-TNF use, and disease duration.|ANCOVA|||The p-value compares Lovastatin with the Placebo treatment group. Log transformed CRP was analyzed to meet the heterogeneity assumption for ANCOVA models.|
1753461|NCT00289198|3222967|Superiority or Other||Mean Difference (Final Values)|-0.491||||0.007||95.0|-0.85|-0.13|||ANCOVA||||
1752709|NCT00302848|3221136|Non-Inferiority or Equivalence|Sample size calculations for VTE risk showed that 50,000 patients should be sufficient to exclude a twofold risk.|Hazard Ratio (HR)|1.0|||<|0.05||95.0|0.6|1.8|||Regression, Cox|||Null hypothesis: HR ≥ 2 (VTE of DRSP vs. LNG)|
1752710|NCT00302718|3221141|Other|||||||0.9895|||||||Chi-squared||||
1752711|NCT00302718|3221143|Other|||||||0.6954|||||||Chi-squared||||
1752712|NCT00302718|3221145|Other|||||||0.2114|||||||Chi-squared||||
1752713|NCT00302718|3221147|Other||||||<|0.0001|||||||Chi-squared||||
1752714|NCT00302081|3221175|Non-Inferiority or Equivalence|Noninferiority for SVR was concluded if the lower limit of the one-sided 95% CI was greater than -10%. Otherwise, noninferiority was concluded for both dose and treatment duration comparisons if the lower limits of the two-sided 95% CIs were greater than -10%.|Risk Difference (RD)|-0.1||||0.495||95.0|-0.17|1.0||The Hochberg procedure was used to adjust for the multiple comparisons ([PEG2b 1.0/R(24 weeks)] - [PEG2b 1.5/R(24 weeks]) and ([PEG2b 1.5/R(16 weeks]-[PEG2b 1.5/R(24 weeks]).|z-test (non-inferiority margin=-0.1)|SVR rates are 0.665 (153/230 subjects) in the 24-week group and 0.566 (129/228 subjects) in the 16-week group, for a risk difference of -0.10.||This is an evaluation of the effect of treatment duration (24 weeks vs 16 weeks) on the primary outcome measure.|
1752715|NCT00302081|3221175|Non-Inferiority or Equivalence|Noninferiority for SVR was concluded if the lower limit of the one-sided 95% CI was greater than -10%. Otherwise, noninferiority was concluded for both dose and treatment duration comparisons if the lower limits of the two-sided 95% CIs were greater than -10%.|Risk Difference (RD)|-0.02||||0.041||95.0|-0.1|1.0||The Hochberg procedure was used to adjust for the multiple comparisons ([PEG2b 1.0/R(24 weeks)] - [PEG2b 1.5/R(24 weeks]) and ([PEG2b 1.5/R(16 weeks)]-[PEG2b 1.5/R(24 weeks)]).|z-test (non-inferiority margin=-0.1)|SVR rates are 0.665 (153/230 subjects) in the 1.5-dose group and 0.643 (144/224 subjects) in the 1.0-dose group, for a risk difference of -0.02.||This is an evaluation of the effect of the peginterferon alfa-2b dose (1.0 vs 1.5 micrograms/kg/week) on the primary outcome measure.|
1752716|NCT00301873|3221201|Superiority or Other||Slope|0.2123|Standard Error of the Mean|0.1209||0.1026||95.0||||the p-value is a test of whether the slope ofl the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between anticonvulsant use and BMD change at 12 months.||59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline anti-convulsant use and bone mass density at 12 months using linear regression|
1752717|NCT00301873|3221201|Superiority or Other||Slope|-0.232|Standard Error of the Mean|0.1029||0.0418||95.0||||this p-value is at test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between baseline steroid use and BMD change at 12 months (outcome).||59 patients were accrued to the study. The 19 patients with follow-up at 12 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 12 months using linear regression|
1752718|NCT00301873|3221201|Superiority or Other||Slope|0.2357|Standard Error of the Mean|0.1091||0.0413||95.0||||this p-value is at test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between anticonvulsant use and BMD change at 6 months (outcome).||59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline anticonvulsant use and bone mass density at 6 months using linear regression|
1752719|NCT00301873|3221201|Superiority or Other||Slope|-0.107|Standard Error of the Mean|0.0855||0.2212||95.0||||The p-value is a test of whether the slope of the regression line is non-zero.|Regression, Linear|The linear regression assesses the relationship between baseline baseline steroid use and BMD change at 6 months (outcome).||59 patients were accrued to the study. The 27 patients with follow-up at 6 months are included in an analysis to assess the association between baseline steroid use and bone mass density at 6 months using linear regression.|
1752720|NCT00301808|3221216|Superiority or Other||Kaplan-Meier product limit|0.66|Standard Error of the Mean|0.1423|||2-Sided|95.0|0.48|0.84|||||||
1752721|NCT00301262|3221231|Superiority or Other||Mean Difference (Net)|4.93|Standard Error of the Mean|6.212||0.429||95.0|-7.35|17.2|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752722|NCT00301262|3221231|Superiority or Other||Mean Difference (Net)|18.86|Standard Error of the Mean|4.952||0.0002||95.0|9.08|28.64|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752723|NCT00301262|3221232|Superiority or Other||Mean Difference (Net)|3.07|Standard Error of the Mean|5.595||0.5849||95.0|-8.02|14.15|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752724|NCT00301262|3221232|Superiority or Other||Mean Difference (Net)|4.56|Standard Error of the Mean|7.474||0.5429||95.0|-10.25|19.37|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752725|NCT00301262|3221233|Superiority or Other||Mean Difference (Net)|-6.62|Standard Error of the Mean|7.318||0.3678||95.0|-21.12|7.88|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752726|NCT00301262|3221233|Superiority or Other||Mean Difference (Net)|14.74|Standard Error of the Mean|7.774||0.0606||95.0|-0.67|30.15|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752727|NCT00301262|3221234|Superiority or Other||Mean Difference (Net)|9.68|Standard Error of the Mean|6.724||0.1527||95.0|-3.64|23.01|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752728|NCT00301262|3221234|Superiority or Other||Mean Difference (Net)|-10.18|Standard Error of the Mean|7.897||0.2001||95.0|-25.83|5.47|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752804|NCT00300755|3221306|Superiority or Other|||||||0.026|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.|
1752729|NCT00301262|3221235|Superiority or Other||Mean Difference (Net)|-0.69|Standard Error of the Mean|4.994||0.8899||95.0|-10.59|9.2|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752730|NCT00301262|3221235|Superiority or Other||Mean Difference (Net)|-0.34|Standard Error of the Mean|5.789||0.9529||95.0|-11.82|11.13|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752731|NCT00301262|3221236|Superiority or Other||Mean Difference (Net)|-0.33|Standard Error of the Mean|1.692||0.8464||95.0|-3.68|3.02|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752732|NCT00301262|3221236|Superiority or Other||Mean Difference (Net)|-1.04|Standard Error of the Mean|4.45||0.8158||95.0|-9.86|7.78|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752733|NCT00301262|3221237|Superiority or Other||Mean Difference (Net)|-2.04|Standard Error of the Mean|1.798||0.2581||95.0|-5.61|1.52|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752734|NCT00301262|3221237|Superiority or Other||Mean Difference (Net)|-3.18|Standard Error of the Mean|1.754||0.0726||95.0|-6.66|0.3|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752735|NCT00301262|3221238|Superiority or Other||Mean Difference (Net)|-5.36|Standard Error of the Mean|3.209||0.0971||95.0|-11.7|0.98|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752736|NCT00301262|3221238|Superiority or Other||Mean Difference (Net)|9.8|Standard Error of the Mean|4.351||0.0257||95.0|1.21|18.39|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752737|NCT00301262|3221239|Superiority or Other||Mean Difference (Net)|-4.74|Standard Error of the Mean|5.818||0.4165||95.0|-16.24|6.76|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752738|NCT00301262|3221239|Superiority or Other||Mean Difference (Net)|22.03|Standard Error of the Mean|5.458|<|0.0001||95.0|11.25|32.81|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752739|NCT00301262|3221240|Superiority or Other||Mean Difference (Net)|-0.62|Standard Error of the Mean|4.883||0.8993||95.0|-10.27|9.03|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752740|NCT00301262|3221240|Superiority or Other||Mean Difference (Net)|-12.23|Standard Error of the Mean|4.829||0.0123||95.0|-21.77|-2.7|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752741|NCT00301262|3221241|Superiority or Other||Mean Difference (Net)|2.37|Standard Error of the Mean|1.489||0.1137||95.0|-0.57|5.31|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752742|NCT00301262|3221241|Superiority or Other||Mean Difference (Net)|-1.77|Standard Error of the Mean|2.126||0.4069||95.0|-5.97|2.43|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752743|NCT00301262|3221242|Superiority or Other||Mean Difference (Net)|1.61|Standard Error of the Mean|1.958||0.4131||95.0|-2.26|5.48|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752744|NCT00301262|3221242|Superiority or Other||Mean Difference (Net)|-2.48|Standard Error of the Mean|1.962||0.2081||95.0|-6.35|1.4|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752745|NCT00301262|3221243|Superiority or Other||Mean Difference (Net)|1.38|Standard Error of the Mean|1.835||0.4523||95.0|-2.24|5.01|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752746|NCT00301262|3221243|Superiority or Other||Mean Difference (Net)|-5.55|Standard Error of the Mean|2.958||0.0624||95.0|-11.39|0.29|||Independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752747|NCT00301262|3221244|Superiority or Other|||||||0.0016|||||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.|
1752748|NCT00301262|3221244|Superiority or Other|||||||0.3173|||||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.|
1752749|NCT00301262|3221245|Superiority or Other||||||<|0.0001|||||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.|
1752750|NCT00301262|3221245|Superiority or Other||||||<|0.0196|||||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.|
1752751|NCT00301262|3221246|Superiority or Other||||||<|0.0001|||||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.|
1752752|NCT00301262|3221246|Superiority or Other||||||<|0.0325|||||||McNemar|||Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.|
1752753|NCT00301262|3221247|Superiority or Other||Mean Difference (Net)|1.99|Standard Deviation|2.178|<|0.0001||95.0|1.454|2.516|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752754|NCT00301262|3221247|Superiority or Other||Mean Difference (Net)|0.45|Standard Deviation|1.606|<|0.0143||95.0|0.093|0.807|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752755|NCT00301262|3221248|Superiority or Other||Mean Difference (Net)|2.61|Standard Deviation|2.335|<|0.0001||95.0|2.042|3.182|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752756|NCT00301262|3221248|Superiority or Other||Mean Difference (Net)|0.65|Standard Deviation|1.917|<|0.0033||95.0|0.223|1.077|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752757|NCT00301262|3221249|Superiority or Other||Mean Difference (Net)|2.67|Standard Deviation|2.573|<|0.0001||95.0|2.044|3.299|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752758|NCT00301262|3221249|Superiority or Other||Mean Difference (Net)|0.4|Standard Deviation|1.489|<|0.0186||95.0|0.069|0.731|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752759|NCT00301262|3221250|Superiority or Other||Mean Difference (Net)|2.09|Standard Deviation|2.207|<|0.0001||95.0|1.551|2.628|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752760|NCT00301262|3221250|Superiority or Other||Mean Difference (Net)|0.39|Standard Deviation|1.454|<|0.0195||95.0|0.064|0.711|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752761|NCT00301262|3221251|Superiority or Other||Mean Difference (Net)|1.2123|Standard Error of the Mean|0.3549||0.0008||95.0|0.511|1.913|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).||
1752762|NCT00301262|3221252|Superiority or Other||Mean Difference (Net)|1.1821|Standard Error of the Mean|0.3946||0.0032||95.0|0.403|1.961|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).||
1752763|NCT00301262|3221253|Superiority or Other||Mean Difference (Net)|1.4454|Standard Error of the Mean|0.3638||0.0001||95.0|0.727|2.164|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).||
1752764|NCT00301262|3221254|Superiority or Other||Mean Difference (Net)|1.167|Standard Error of the Mean|0.3041||0.0002||95.0|0.566|1.768|||2-sample independent t-test||A 2-sample independent t-test was used to test the difference between treatment for the change between baseline and Week 8 (change = Week 8 - baseline).||
1752765|NCT00301262|3221255|Superiority or Other||Mean Difference (Net)|-7.6|Standard Error of the Mean|3.903||0.0533||95.0|-15.32|0.11|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752766|NCT00301262|3221256|Superiority or Other||Mean Difference (Net)|-7.97|Standard Error of the Mean|3.901||0.0427||95.0|-15.68|-0.27|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752767|NCT00301262|3221257|Superiority or Other||Mean Difference (Net)|9.72|Standard Error of the Mean|4.496||0.0321||95.0|0.84|18.6|||independent-samples t-test||Mean Difference = Week 8 - Baseline||
1752768|NCT00301262|3221258|Superiority or Other||Mean Difference (Net)|13.9|Standard Error of the Mean|4.716||0.0037||95.0|4.59|23.22|||independent-samples t-test||Independent-samples t-test was used to test mean difference of zero between treatment groups (Viagra - Placebo) at each visit interval.||
1752769|NCT00301262|3221259|Superiority or Other||Odds Ratio (OR)|3.676||||0.0187||95.0|1.242|10.875|||Regression, Logistic||||
1752770|NCT00301262|3221260|Superiority or Other||Odds Ratio (OR)|4.915|||<|0.0001||95.0|2.396|10.08|||Regression, Logistic||||
1752771|NCT00301262|3221261|Superiority or Other||Odds Ratio (OR)|6.491||||0.0001||95.0|3.042|13.851|||Regression, Logistic||||
1752772|NCT00301262|3221262|Superiority or Other||Mean Difference (Net)|26.8|Standard Deviation|29.384|<|0.0001|2-Sided|95.0|19.636|33.971|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752773|NCT00301262|3221262|Superiority or Other||Mean Difference (Net)|6.41|Standard Deviation|20.444|<|0.0064||95.0|1.857|10.956|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752774|NCT00301262|3221263|Superiority or Other||Mean Difference (Final Values)|18.42|Standard Error of the Mean|4.826||0.0002||95.0|8.88|27.96|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.||
1752775|NCT00301262|3221264|Superiority or Other||Mean Difference (Net)|5.54|Standard Deviation|6.463|<|0.0001||95.0|3.961|7.114|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752776|NCT00301262|3221264|Superiority or Other||Mean Difference (Net)|-0.06|Standard Deviation|5.193|<|0.9146||95.0|-1.218|1.093|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752777|NCT00301262|3221265|Superiority or Other||Mean Difference (Final Values)|2.78|Standard Error of the Mean|1.038||0.0083||95.0|0.73|4.83|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.||
1752778|NCT00301262|3221266|Superiority or Other||Mean Difference (Net)|1.9|Standard Deviation|2.297|<|0.0001||95.0|1.335|2.456|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752779|NCT00301262|3221266|Superiority or Other||Mean Difference (Net)|0.68|Standard Deviation|1.847|<|0.0016||95.0|0.264|1.086|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752780|NCT00301262|3221267|Superiority or Other||Mean Difference (Net)|2.28|Standard Deviation|2.979|<|0.0001||95.0|1.557|3.01|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752781|NCT00301262|3221267|Superiority or Other||Mean Difference (Net)|0.75|Standard Deviation|2.548|<|0.0102||95.0|0.183|1.317|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752782|NCT00301262|3221268|Superiority or Other||Mean Difference (Net)|0.76|Standard Deviation|1.706||0.0005||95.0|0.345|1.177|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752783|NCT00301262|3221268|Superiority or Other||Mean Difference (Net)|0.18|Standard Deviation|1.456||0.2857||95.0|-0.149|0.499|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752784|NCT00301262|3221269|Superiority or Other||Mean Difference (Net)|1.39|Standard Deviation|2.582|<|0.0001||95.0|0.758|2.018|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752785|NCT00301262|3221269|Superiority or Other||Mean Difference (Net)|0.2|Standard Deviation|1.57|<|0.2581||95.0|-0.149|0.549|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752786|NCT00301262|3221270|Superiority or Other||Mean Difference (Net)|5.22|Standard Deviation|6.346|<|0.0001||95.0|3.676|6.772|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752787|NCT00301262|3221270|Superiority or Other||Mean Difference (Net)|1.49|Standard Deviation|4.392|<|0.0033||95.0|0.051|2.465|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752788|NCT00301262|3221271|Superiority or Other||Mean Difference (Final Values)|0.9|Standard Error of the Mean|0.359||0.0135||95.0|0.19|1.61|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.||
1752789|NCT00301262|3221272|Superiority or Other||Mean Difference (Final Values)|1.2|Standard Error of the Mean|0.458||0.0096||95.0|0.3|2.11|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.||
1752790|NCT00301262|3221273|Superiority or Other||Mean Difference (Final Values)|0.68|Standard Error of the Mean|0.277||0.0156||95.0|0.13|1.22|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.||
1752791|NCT00301262|3221274|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.368||0.4232||95.0|-0.43|1.02|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.||
1752792|NCT00301262|3221275|Superiority or Other||Mean Difference (Final Values)|2.61|Standard Error of the Mean|0.922||0.0054||95.0|0.78|4.43|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.||
1752793|NCT00301262|3221276|Superiority or Other||Mean Difference (Net)|2.79|Standard Deviation|4.013|<|0.0001||95.0|1.812|3.77|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752794|NCT00301262|3221276|Superiority or Other||Mean Difference (Net)|0.94|Standard Deviation|2.909|<|0.0051||95.0|0.29|1.585|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752795|NCT00301262|3221277|Superiority or Other||Mean Difference (Final Values)|1.76|Standard Error of the Mean|0.656||0.008||95.0|0.47|3.06|||ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.||
1752796|NCT00301262|3221278|Superiority or Other||Mean Difference (Net)|26.02|Standard Deviation|22.294|<|0.0001||95.0|20.58|31.455|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752797|NCT00301262|3221278|Superiority or Other||Mean Difference (Net)|5.09|Standard Deviation|14.761|<|0.0028||95.0|1.8|8.37|||paired t-test||A paired t-test was used to examine the within treatment difference between week 8 and week 14 (open label phase).||
1752798|NCT00301262|3221279|Superiority or Other||Mean Difference (Final Values)|18.13|Standard Error of the Mean|3.405|<|0.0001||95.0|11.4|24.86||Since there was only one primary endpoint no multiple comparison adjustments were made for primary analysis. Final stat. model included centre, treatment, smoking status and history of ED as factors, and age, duration of ED (baseline) as covariates.|ANCOVA||Mean difference between the sidenafil group compared to the placebo group was calculated along with 95% confidence intervals for these differences.|The primary analysis population was the FAS. The sample size was estimated based on an expected difference of 16.5 with a standard deviation of 28.4, based on previously observed data.|
1752799|NCT00300885|3221297|Superiority or Other||difference in response rate (CR+PR rate)|-3.65||||0.1015||95.0|-9.18|1.89||no adjustments|Cochran-Mantel-Haenszel||difference in response rates (Complete Response (CR) + Partial Response (PR)) = Placebo+C/P - Sorafenib+C/P|Objective response rate (ie. CR+PR rate) was compared between treatment arms using Cochran-Mantel-Haenszel test with one-side alpha 0.025 adjusting for same stratification factors as randomization|
1752800|NCT00300885|3221298|Superiority or Other||Hazard Ratio (HR)|0.99||||0.433||95.0|0.84|1.16|||Log Rank|||Two treatment groups compared using one-sided log-rank test (Sorafenib+C/P over Placebo+C/P) with alpha of 0.025 stratified by same stratification factors at randomization|
1752801|NCT00300885|3221299|Superiority or Other||Hazard Ratio (HR)|1.15||||0.915||95.0|0.94|1.41||According to protocol specified O'Brien-Fleming type alpha spending function and 384 deaths at interim analysis (IA), one-sided alpha value for IA was 0.0046.|Log Rank||Two treatment groups compared using one-sided log-rank test (Sorafenib+C/P over Placebo+C/P) with overall alpha of 0.025 stratified by same stratification factors as randomization|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 30% improvement in median OS (i.e. HR of 0.76923, Sorafenib+C/P over Placebo+C/P -Null: theta>=1, Alternative: theta<=0.76923). With overall one-sided alpha of 0.025, 90% power and randomization of 1:1, one formal interim analysis and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of 614 events (deaths) were required.|
1752802|NCT00300755|3221305|Superiority or Other|||||||0.047|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for Noisy breathing.|
1752803|NCT00300755|3221305|Superiority or Other|||||||0.004|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for Cough without cold.|
1753462|NCT00289198|3222968|Superiority or Other||Mean Difference (Final Values)|-0.506||||0.004|2-Sided|95.0|-0.85|-0.16|||ANCOVA||||
1752805|NCT00300755|3221306|Superiority or Other|||||||0.026|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.|
1752806|NCT00300755|3221306|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Abdominal/belly pain.|
1752807|NCT00300755|3221306|Superiority or Other|||||||0.044|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Difficulty swallowing.|
1752808|NCT00300755|3221306|Superiority or Other|||||||0.004|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Difficulty swallowing.|
1752809|NCT00300755|3221306|Superiority or Other|||||||0.009|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Refusal to eat.|
1752810|NCT00300755|3221306|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Choking/gagging.|
1752811|NCT00300755|3221306|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Choking/gagging.|
1752812|NCT00300755|3221306|Superiority or Other||||||<|0.033|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.|
1752813|NCT00300755|3221306|Superiority or Other||||||<|0.002|||||||t-test, 2 sided|||Within group analysis of final week change from baseline for symptom Vomiting/regurgitation.|
1752814|NCT00300755|3221307|Superiority or Other|||||||0.217|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.|
1752815|NCT00300755|3221307|Superiority or Other|||||||0.082|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.|
1752816|NCT00300755|3221307|Superiority or Other|||||||0.004|||||||ANCOVA|Analysis with treatment group and baseline age as fixed effects, and baseline GERD symptom score and baseline antacid use as covariates||Between group analysis of final week change from baseline.|
1752817|NCT00300755|3221307|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.|
1752818|NCT00300755|3221307|Superiority or Other||||||<|0.063|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.|
1752819|NCT00300755|3221307|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Within group analysis of final week change from baseline.|
1752820|NCT00300677|3221313|Superiority or Other||postdose: ratio adjusted mean|31.57||||||90.0|18.06|55.18|||||Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.|
1752821|NCT00300677|3221313|Superiority or Other||predose: ratio adjusted mean|12.39||||||90.0|7.09|21.65|||||Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plama (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.|
1752822|NCT00300677|3221314|Superiority or Other||postdose: ratio adjusted geometric means|31.57||||||90.0|18.06|55.18|||||Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.|
1752823|NCT00300677|3221314|Superiority or Other||predose: ratio adjusted geometric means|12.39||||||90.0|7.09|21.65|||||Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole N-oxide.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole N-oxide. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.|
1752824|NCT00300677|3221315|Superiority or Other||postdose: ratio adjusted geometric means|192.72||||||90.0|123.81|300.0|||||Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.|
1752825|NCT00300677|3221315|Superiority or Other||predose: ratio adjusted geometric means|300.28||||||90.0|192.91|467.43|||||Estimated value = ratio (%) of the adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.|
1754135|NCT00283712|3223594|Superiority or Other||Risk Difference (RD)|0.2||||0.65|2-Sided|90.0|-0.15|0.55|||Fisher Exact||||
1752826|NCT00300677|3221316|Superiority or Other||postdose: ratio adjusted geometric means|192.72||||||90.0|123.81|300.0|||||Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 post-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.|
1752827|NCT00300677|3221316|Superiority or Other||predose: ratio adjusted geometric means|300.28||||||90.0|192.91|467.43|||||Estimated value = ratio (%) of adjusted geometric means comparing brain (test) vs. plasma (reference) concentrations of voriconazole.|Other estimated parameter represents the Day 3 pre-dose ratio of the adjusted geometric means comparing brain vs. plasma concentrations of voriconazole. Natural-log transformed concentrations of voriconazole were analyzed using a mixed-effects model to obtain the adjusted mean difference (Test-Reference) and 90% confidence interval for the difference which were exponentiated to provide estimates of the ratio of the adjusted geometric means and 90% CI for the ratio.|
1752828|NCT00300482|3221324|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%|
1752829|NCT00300482|3221324|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 99% power to detect a 43% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%|
1752830|NCT00300482|3221325|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%|
1752831|NCT00300482|3221325|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide 92% power to detect a 5% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%|
1752832|NCT00300482|3221326|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide >99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%|
1752833|NCT00300482|3221326|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 205 per arm would provide >99% power to detect a 17% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%|
1752834|NCT00300469|3221332|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide >99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%|
1752835|NCT00300469|3221332|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide >99% power to detect a 31% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%|
1752836|NCT00300469|3221333|Superiority or Other|||||||0.01||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%|
1752837|NCT00300469|3221333|Superiority or Other|||||||0.005||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 99% power to detect a 13% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%|
1752838|NCT00300469|3221334|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide >99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%|
1752839|NCT00300469|3221334|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide >99% power to detect a 20% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%|
1752840|NCT00300456|3221340|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide >99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%|
1754300|NCT00281918|3223870|Superiority or Other|||||||0.0427|||||||Log Rank||||
1752841|NCT00300456|3221340|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide >99% power to detect an 11% decrease in LDL-C relative to ABT-335 monotherapy for each combo therapy dose, assuming an SD of 15%|
1752842|NCT00300456|3221341|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%|
1752843|NCT00300456|3221341|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide 98% power to detect a 9% increase in HDL-C relative to statin monotherapy for each combo therapy dose, assuming an SD of 15%|
1752844|NCT00300456|3221342|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide >99% power to detect 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%|
1752845|NCT00300456|3221342|Superiority or Other||||||<|0.001||||||alpha = 0.05, all 3 primary endpoints had to show superiority of combo therapy in order to declare combo therapy successful at a given statin dose, Hochberg method for multiple comparison adjustment for 2 statin doses|ANCOVA|||An n = 92 per arm would provide >99% power to detect a 24% decrease in triglycerides relative to statin monotherapy for each combo therapy dose, assuming an SD of 30%|
1752846|NCT00300365|3221356|Superiority||||||<|0.0001|||||||Mixed Models Analysis||||
1752847|NCT00300235|3221370|Superiority or Other||proportion of subjects|35.2||||||95.0|32.5|37.9||||||This was a survey designed to estimate prevalence, no formal comparisons between age or genotype groups were performed.|
1752848|NCT00299975|3221373|Superiority or Other||||||<|0.05|||||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.|||
1752849|NCT00299975|3221374|Superiority or Other||||||<|0.05|||||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.|||
1752850|NCT00299975|3221375|Superiority or Other||||||<|0.05|||||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.|||
1752851|NCT00299975|3221376|Superiority or Other||||||<|0.05|||||||Paired-Samples T Test|Paired-Samples T Test was implemented between pre-treatment (Wk2) and post-treatment (Wk10) of each treatment group.|||
1752852|NCT00299975|3221378|Superiority or Other||||||<|0.05|||||||ANOVA||||
1752853|NCT00299975|3221379|Superiority or Other||||||<|0.05|||||||ANOVA||||
1752854|NCT00299975|3221380|Superiority or Other||||||<|0.05|||||||ANOVA||||
1752855|NCT00299975|3221381|Superiority or Other||||||<|0.05|||||||ANOVA||||
1752856|NCT00299975|3221382|Superiority or Other||||||<|0.05|||||||ANOVA||||
1752857|NCT00299975|3221383|Superiority or Other||||||<|0.05|||||||ANOVA||||
1752858|NCT00299975|3221384|Superiority or Other||||||<|0.05|||||||Chi-squared|Chi-squared test from Crosstabs analysis was implemented between three treatment groups in each time frame.|||
1752859|NCT00299975|3221385|Superiority or Other||||||<|0.05|||||||ANOVA||||
1752860|NCT00299975|3221386|Superiority or Other||||||<|0.05|||||||ANOVA||||
1752861|NCT00299975|3221387|Superiority or Other||||||<|0.05|||||||Chi-squared|Chi-squared test from Crosstabs analysis.|||
1752862|NCT00299975|3221388|Superiority or Other||||||<|0.05|||||||Chi-squared|Chi-squared test from Crosstabs analysis.|||
1752863|NCT00299702|3221391|Superiority or Other|||||||0.646||||||Hochberg procedure was used for adjusting multiple endpoint comparisons|Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in time in remission between the two treatment groups|
1752864|NCT00299702|3221392|Superiority or Other|||||||0.684||||||Hochberg procedure was used for adjusting multiple endpoint comparisons|Log Rank|Insufficient number of subjects who had an event for median estimation.||Null hypothesis: there is no difference in time to relapse|
1752865|NCT00299546|3221395|Superiority or Other||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3.|ANOVA on van der Waerden normal scores.|Stratified by baseline MTX.|||
1752866|NCT00299546|3221395|Superiority or Other||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3.|ANOVA on van der Waerden normal scores.|Stratified by baseline MTX.|||
1752867|NCT00299546|3221395|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|Stratified by baseline Methotrexate (MTX).|||
1752868|NCT00299546|3221396|Superiority or Other||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.|||
1752869|NCT00299546|3221396|Superiority or Other||||||<|0.002||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.|||
1752870|NCT00299546|3221396|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX).|||
1752871|NCT00299546|3221397|Superiority or Other||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.|||
1752872|NCT00299546|3221397|Superiority or Other||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.|||
1752873|NCT00299546|3221397|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methorexate (MTX).|||
1752874|NCT00299546|3221398|Superiority or Other|||||||0.002||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.|||
1752875|NCT00299546|3221398|Superiority or Other|||||||0.021||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.|||
1752876|NCT00299546|3221398|Superiority or Other|||||||0.003|||||||Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX).|||
1752877|NCT00299546|3221399|Superiority or Other||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX.||Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 3 :100 mg.|
1752878|NCT00299546|3221399|Superiority or Other||||||<|0.001||||||Test was performed because Group 1: Placebo was significantly different from Combined Groups 2 & 3.|Cochran-Mantel-Haenszel|Stratified by baseline MTX||Null Hypothesis: No difference in ACR 20 response at Wk 14 between Group 1: Placebo and Group 2: 50 mg.|
1752879|NCT00299546|3221399|Superiority or Other||||||<|0.001||||||A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.|Cochran-Mantel-Haenszel|Stratified by baseline Methotrexate (MTX)||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Group 1 vs. Combined Groups 2 and 3. A sample size of 140 patients per group provides a >90% power assuming 50% of patients used Methotrexate (MTX) at baseline and 30% ACR 20 response in placebo and 40~55% ACR 20 response in golimumab groups.|
1752880|NCT00299221|3221456|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Deviation|0.4||0.44||95.0|||||t-test, 2 sided|||comparing ISHLT biopsy score between groups at 1 year|
1752881|NCT00299104|3221494|Superiority or Other||||||<|0.0001||||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.|
1752882|NCT00299104|3221494|Superiority or Other||||||<|0.0001||||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.|
1752883|NCT00299104|3221498|Superiority or Other||||||<|0.0001||||||This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Week 104: Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status.|
1752884|NCT00299104|3221504|Superiority or Other||||||<|0.0001||||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.|
1752885|NCT00299104|3221504|Superiority or Other||||||<|0.0001||||||Secondary endpoint in hierarchical testing structure.|ANOVA|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate stratified for region and RF status.|
1752886|NCT00299104|3221514|Superiority or Other||||||<|0.0001||||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status|
1752887|NCT00299104|3221514|Superiority or Other||||||<|0.0001||||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status|
1752888|NCT00299104|3221519|Superiority or Other|||||||0.3096||||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status|
1752889|NCT00299104|3221519|Superiority or Other|||||||0.5478||||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status|
1752890|NCT00299104|3221519|Superiority or Other|||||||0.5939||||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Kruskal-Wallis|||Comparing all three treatment groups.|
1752891|NCT00299104|3221520|Superiority or Other|||||||0.0081||||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab (1.0 g x 2) + Methotrexate verus Placebo + Methotrexate, stratified for region and Baseline RF status.|
1752892|NCT00299104|3221520|Superiority or Other|||||||0.3752||||||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.|
1752893|NCT00299104|3221521|Superiority or Other||Mean Difference (Net)|0.1||||0.0309||95.0|0.01|0.18||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status|
1752894|NCT00299104|3221521|Superiority or Other||Mean Difference (Net)|0.04||||0.3803||95.0|-0.05|0.13||This was a secondary endpoint in a hierarchical testing structure.|Cochran-Mantel-Haenszel|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status|
1752895|NCT00299104|3221522|Superiority or Other|||||||0.0001||||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status|
1752896|NCT00299104|3221522|Superiority or Other|||||||0.1194||||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status|
1752897|NCT00299104|3221522|Superiority or Other|||||||0.0004||||||The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.|Kruskal-Wallis|||Comparing all three treatment groups|
1752898|NCT00299104|3221523|Superiority or Other|||||||0.0004||||||The Closure Principle was used to adjust for multiple comparisons.|Van-Elteren|||Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status|
1752899|NCT00299104|3221523|Superiority or Other|||||||0.1824||||||The Closure Principle was used to adjust for multiple comparisons.|Van-Elteren|||Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status|
1754301|NCT00281918|3223871|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1752900|NCT00299104|3221523|Superiority or Other|||||||0.0016||||||The Closure Principle was used to adjust for multiple comparisons.|Kruskal-Wallis|||Comparing all three treatment groups|
1752901|NCT00298558|3221550|Superiority or Other||Effect Size|-0.05||||0.56|2-Sided|99.0|-0.26|0.16|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752902|NCT00298558|3221550|Superiority or Other||Effect Size|-0.004||||0.96|2-Sided|99.0|-0.21|0.21|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752903|NCT00298558|3221550|Superiority or Other||Effect Size|0.02||||0.78|2-Sided|99.0|-0.19|0.23|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752904|NCT00298558|3221551|Superiority or Other||Effect Size|0.008||||0.93|2-Sided|99.0|-0.23|0.24|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752905|NCT00298558|3221551|Superiority or Other||Effect Size|-0.02||||0.86|2-Sided|99.0|-0.25|0.22|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752906|NCT00298558|3221551|Superiority or Other||Effect Size|0.004||||0.97|2-Sided|99.0|-0.23|0.24|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752907|NCT00298558|3221552|Superiority or Other||Effect Size|0.36|||<|0.01|2-Sided|99.0|0.01|0.72|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752908|NCT00298558|3221552|Superiority or Other||Effect Size|0.38|||<|0.01|2-Sided|99.0|0.02|0.74|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752909|NCT00298558|3221552|Superiority or Other||Effect Size|0.48|||<|0.01|2-Sided|99.0|0.12|0.84|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752924|NCT00298233|3221610|Superiority or Other|||||||0.54||||||Significance assessed at the 5% level for a two-sided comparison|Mantel Haenszel|Mantel-Haenszel chi-square stratified by study site|||
1752925|NCT00298233|3221611|Superiority or Other|||||||0.54||||||Significance assessed at the 5% level for a two-sided comparison|Mantel Haenszel||||
1752965|NCT00297258|3221703|Superiority or Other||percentage of participants|49.0|||<|0.001||90.0|34.3|63.2|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.||
1752910|NCT00298558|3221553|Superiority or Other||Effect Size|0.66|||<|0.01|2-Sided|99.0|0.43|0.88|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752911|NCT00298558|3221553|Superiority or Other||Effect Size|0.005|||<|0.95|2-Sided|99.0|-0.22|0.23|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752912|NCT00298558|3221553|Superiority or Other||Effect Size|-0.07|||<|0.45|2-Sided|99.0|-0.29|0.16|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752913|NCT00298558|3221555|Superiority or Other||Effect Size|-0.06||||0.27|2-Sided|99.0|-0.2|0.08|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752914|NCT00298558|3221555|Superiority or Other||Effect Size|0.23|||<|0.01|2-Sided|99.0|0.09|0.38|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752915|NCT00298558|3221555|Superiority or Other||Effect Size|-0.02|||<|0.69|2-Sided|99.0|-0.17|0.12|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752916|NCT00298558|3221558|Superiority or Other||Effect Size|-0.05||||0.52|2-Sided|99.0|-0.25|0.15|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752917|NCT00298558|3221558|Superiority or Other||Effect Size|-0.11||||0.17|2-Sided|99.0|-0.31|0.1|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752918|NCT00298558|3221558|Superiority or Other||Effect Size|0.06||||0.43|2-Sided|99.0|-0.14|0.27|||Mixed Models Analysis|The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.|Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.|Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.|
1752919|NCT00298389|3221559|Superiority|||||||0.05|||||||Kruskal-Wallis||||
1752920|NCT00298389|3221560|Superiority|||||||0.05||||||calculated|Kruskal-Wallis||||
1752921|NCT00298233|3221607|Superiority or Other|||||||0.58||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis||||
1752922|NCT00298233|3221608|Superiority or Other|||||||0.66||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis||||
1752923|NCT00298233|3221609|Superiority or Other|||||||0.48||||||Significance assessed at the 5% level for a two-sided comparison|Kruskal-Wallis||||
1754302|NCT00281918|3223872|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1752926|NCT00298233|3221612|Superiority or Other|||||||0.42||||||Significance assessed at the 5% level for a two-sided comparison|conditional univariate logistic regressi|analysis stratified by study site||Based on previous studies, assumption was made that 30% of children and 55% of adults treated with standard dose oseltamivir would test negative for virus on day five. This would require a sample size of 242 patients to show a 20% absolute improvement in cessation of viral shedding with 85% power and a two sided α of 0.05. To allow for study withdrawals, the target sample size was set at 300 patients.|
1752927|NCT00298090|3221615|Superiority or Other||Other|0.0||||0.55|2-Sided|95.0|-0.8|1.48|||repeated measures model||A repeated measures model was used to assess whether the one-minute average StO2 values differed systematically between pre and post arterial line placement.||
1752928|NCT00298038|3221621|Superiority|Analysis based on the overall comparison of time to the first breakthrough overt HE episode between rifaximin and placebo groups adjusting for analysis region, using the Cox proportional hazards model (Score test, [that is, Log rank test stratified by analysis region]) with a 2-sided test at a significance level of 0.05 under the proportional hazards assumption.|Hazard Ratio (HR)|0.421|||<|0.0001|2-Sided|95.0|0.276|0.641|||Cox proportional hazards model||||
1752929|NCT00297778|3221627|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.2||0.5231|2-Sided|95.0|-0.5|0.2|||ANCOVA|||N’s exclude patients from the analysis set with incomplete data|
1752930|NCT00297778|3221628|Superiority or Other||Hodges−Lehmann est of diff in medians|0.0||||0.141|2-Sided|95.0|0.0|0.0|||Wilcoxon rank sum (Van Elteren's test)||95% Confidence interval is Distribution−free Confidence Interval (Moses).|N’s exclude patients from the analysis set with incomplete data|
1752931|NCT00297778|3221629|Superiority or Other||Mean Difference (Net)|-0.5||||0.8471||95.0|-5.6|4.6|||ANCOVA||||
1752932|NCT00297778|3221630|Superiority or Other||Hodges-Lehmann est of diff in medians|0.04||||0.0337||95.0|0.0|0.09|||Wilcoxon rank sum (Van Elteren's test)||||
1752933|NCT00297778|3221631|Superiority or Other||Median Difference (Net)|-1.3||||0.1925||95.0|-3.3|0.8|||van Elteren (country stratification)||||
1752934|NCT00297778|3221632|Superiority or Other||Odds Ratio (OR)|1.821||||0.006||95.0|1.187|2.794|||Regression, Logistic||||
1752935|NCT00297778|3221633|Superiority or Other||Mean Difference (Net)|-3.4||||0.0007||95.0|-5.4|-1.5|||ANCOVA||||
1752936|NCT00297778|3221634|Superiority or Other||Mean Difference (Net)|-2.2||||0.0034||95.0|-3.7|-0.7|||ANCOVA||||
1752937|NCT00297778|3221635|Superiority or Other||Mean Difference (Net)|-1.2||||0.003||95.0|-1.9|-0.4|||ANCOVA||||
1752938|NCT00297778|3221636|Superiority or Other||Median Difference (Net)|0.0||||0.141||95.0|0.0|0.0|||van Elteren (country stratification)||||
1752939|NCT00297778|3221637|Superiority or Other||Mean Difference (Net)|0.0||||0.5244||95.0|-1.0|0.0|||Wilcoxon (Mann-Whitney)||||
1752940|NCT00297778|3221638|Superiority or Other||Mean Difference (Net)|-0.8||||0.0346||95.0|-1.5|-0.1|||ANCOVA||||
1752941|NCT00297778|3221639|Superiority or Other||Odds Ratio (OR)|1.758||||0.0535||95.0|0.992|3.115|||Regression, Logistic||||
1752942|NCT00297778|3221640|Superiority or Other||Mean Difference (Net)|-1.9||||0.0103||95.0|-3.4|-0.5|||ANCOVA||||
1752943|NCT00297492|3221679|Superiority or Other||Odds Ratio (OR)|0.59|||||2-Sided|95.0|0.28|1.22|||||The reported odds ratio represents the odds of 6 month prolonged abstinence in the gradual reduction group divided by the odds of 6 month prolonged abstinence in the abrupt cessation group.||
1752944|NCT00297492|3221679|Superiority or Other|||||||0.3||||||Statistical significance was determined by a two-sided p value less than 0.05.|Chi-squared|Degrees of freedom = 2||"Null hypothesis: prolonged abstinence from smoking is the same for the three groups at 6 month follow-up~Sample size was based on an assumption of 6 month abstinence of 25% in the gradual group, 15% in the abrupt group, and 10% in the minimal group. Sample sizes of 300, 300, and 150 for gradual, abrupt, and minimal provides 97% to detect a difference between the groups, with 2-sided alpha = 0.05."|
1752945|NCT00297427|3221680|Superiority or Other|||||||0.86|||||||t-test, 2 sided||||
1752946|NCT00297427|3221681|Superiority or Other|||||||0.48|||||||t-test, 2 sided||||
1752947|NCT00297427|3221682|Superiority or Other||||||<|0.001|||||||t-test, 1 sided||||
1752948|NCT00297427|3221684|Superiority or Other|||||||0.78|||||||Wilcoxon (Mann-Whitney)||||
1752949|NCT00297427|3221685|Superiority or Other|||||||0.64|||||||t-test, 2 sided||||
1752950|NCT00297427|3221686|Superiority or Other||Odds Ratio (OR)|0.936||||0.03|2-Sided|95.0|0.881|0.994|||Regression, Logistic||These are the adjusted results from a multivariate logistic regression analysis.||
1752951|NCT00297427|3221686|Superiority or Other|||||||0.023||||||This is the result from the bivariate (unadjusted) analysis.|t-test, 2 sided||||
1752952|NCT00297427|3221687|Superiority or Other||Odds Ratio (OR)|1.208||||0.014|2-Sided|95.0|1.039|1.405|||Regression, Logistic||These are the adjusted results of a multivariate logistic regression.||
1752953|NCT00297427|3221687|Superiority or Other|||||||0.04||||||Bivariate (unadjusted) analysis|t-test, 2 sided||||
1752954|NCT00297427|3221688|Superiority or Other|||||||0.41|||||||Repeated measures using GEE||||
1752955|NCT00297427|3221689|Superiority or Other|||||||0.01|||||||Repeated measures using GEE||||
1752956|NCT00297427|3221690|Superiority or Other|||||||0.04|||||||Repeated measures using GEE||||
1752957|NCT00297427|3221692|Superiority or Other|||||||0.43|||||||Wilcoxon (Mann-Whitney)||||
1752958|NCT00297427|3221693|Superiority or Other|||||||0.38|||||||Wilcoxon (Mann-Whitney)||||
1752959|NCT00297427|3221694|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)||||
1752960|NCT00297427|3221696|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)||||
1752961|NCT00297427|3221697|Superiority or Other|||||||0.16|||||||Wilcoxon (Mann-Whitney)||||
1752962|NCT00297427|3221698|Superiority or Other|||||||0.32|||||||t-test, 2 sided||||
1752963|NCT00297427|3221699|Superiority or Other|||||||0.02|||||||t-test, 2 sided||||
1752964|NCT00297258|3221703|Superiority or Other||percentage of participants|41.0||||0.003||90.0|28.4|55.5|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.||
1753020|NCT00295022|3222036|Superiority or Other||Mean Difference (Final Values)|-0.93|||=|0|2-Sided|95.0|-2.04|0.18|||ANCOVA||||
1752966|NCT00297258|3221703|Superiority or Other||percentage of participants|41.0|||<|0.003||90.0|28.4|55.5|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.||
1752967|NCT00297258|3221703|Superiority or Other||percentage of participants|46.0|||<|0.653||90.0|11.0|47.6|||binomial exact method||The estimated value represents the percentage of participants with a CR, a PR, or SD.||
1752968|NCT00297167|3221715|Superiority or Other||LS Mean Difference|-21.5|||<|0.001|2-Sided|95.0|-26.85|-16.14|||ANOVA|||P-Value was calculated using analysis of variance (ANOVA)model which included main effects for treatment and sequence and participant nested in sequence as a random effect.|
1752969|NCT00297167|3221716|Superiority or Other||Least Square (LS) Mean Difference|-25.52|||<|0.001|2-Sided|95.0|-31.73|-19.32|||ANOVA|||P-Value was calculated using analysis of variance (ANOVA) model which included main effects for treatment and sequence and participant nested in sequence as a random effect.|
1752970|NCT00297115|3221717|Superiority or Other||Mean Difference (Final Values)|0.286|Standard Error of the Mean|0.104||0.0059|2-Sided|95.0|0.082|0.489||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).|||
1752971|NCT00297115|3221718|Superiority or Other||Mean Difference calculated as ratio|1.0593||||0.3627|2-Sided|95.0|0.9356|1.1994||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|ANCOVA model including last observation carried forward (LOCF) method|||
1752972|NCT00297115|3221719|Superiority or Other||Hazard Ratio (HR)|1.213|Standard Error of the Mean|0.35||0.5028|2-Sided|95.0|0.689|2.137||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Cox proportional hazards regression||The statistical analysis is based on the ITT Analysis Set (n= 772 in the roflumilast group, n= 796 in the placebo group).||
1752973|NCT00297115|3221720|Superiority or Other||Mean Difference (Net)|61.0|Standard Error of the Mean|9.0|<|0.0001|2-Sided|95.0|44.0|79.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).|||
1752974|NCT00297115|3221721|Superiority or Other||Rate ratio|0.815|Standard Error of the Mean|0.057||0.0035|2-Sided|95.0|0.71|0.935||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Poisson regression||||
1752975|NCT00297115|3221722|Superiority or Other||Mean Difference (Net)|58.0|Standard Error of the Mean|9.0|<|0.0001|2-Sided|95.0|41.0|75.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).|||
1752976|NCT00297102|3221723|Superiority or Other||Mean Difference (Final Values)|0.233|Standard Error of the Mean|0.111||0.0356|2-Sided|95.0|0.016|0.449||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).|||
1752977|NCT00297102|3221724|Superiority or Other||Mean Difference calculated as ratio|0.9521||||0.4089|2-Sided|95.0|0.8472|1.0699||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|ANCOVA model including last observation carried forward (LOCF) method|||
1752978|NCT00297102|3221725|Superiority or Other||Hazard Ratio (HR)|1.035|Standard Error of the Mean|0.357||0.9212|2-Sided|95.0|0.526|2.034||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Cox proportional hazards regression||The statistical analysis is based on the ITT Analysis Set (n= 765 in the roflumilast group, n= 758 in the placebo group).||
1752979|NCT00297102|3221726|Superiority or Other||Mean Difference (Net)|49.0|Standard Error of the Mean|11.0|<|0.0001|2-Sided|95.0|26.0|71.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).|||
1752980|NCT00297102|3221727|Superiority or Other||Rate ratio|0.851|Standard Error of the Mean|0.062||0.0278|2-Sided|95.0|0.737|0.982||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|Poisson regression||||
1752981|NCT00297102|3221728|Superiority or Other||Mean Difference (Net)|39.0|Standard Error of the Mean|11.0||0.0003|2-Sided|95.0|18.0|60.0||No adjustment of the significance level was done as a hierarchical approach for hypotheses testing was used.|ANCOVA|Repeated measurements analysis (change from baseline over 52 weeks of treatment taking all post-randomization measurements into account).|||
1752982|NCT00296517|3221745|Superiority or Other (legacy)|||||||0.036|||||||Log Rank||||
1752983|NCT00296517|3221755|Superiority or Other (legacy)||Mean Difference (Net)|0.2||||0.805||95.0|-1.6|2.0|||ANOVA|||Null Hypothesis: The population mean change from baseline on HAM-D total score at Week 12 of the placebo group is equal to the population mean change from baseline on HAMD total score at Week 12 of the Bupropion hydrochloride sustained release group.|
1752984|NCT00296491|3221785|Non-Inferiority or Equivalence|Given estimates, and assuming a significance level of a=0.05, a sample size of 133 subjects per treatment was determined to be sufficient to provide 80% power to show equivalance.|Mean Difference (Net)|-8.9|Standard Error of the Mean|8.0|<|0.127||95.0|-24.6|6.9|||t-test, 2 sided||Treatment Difference=FSC+MON-FSC||
1752985|NCT00296491|3221786|Superiority or Other||Mean Difference (Net)|23.2|Standard Error of the Mean|5.41|<|0.001||95.0|12.5|33.8|||t-test, 2 sided||Treatment Difference = FSC - MON||
1752986|NCT00296231|3221948|Superiority or Other|||||||0.011|||||||t-test, 2 sided|||Paired Student's t-test was used to compare pre and post intervention pCO2 values.|
1752987|NCT00296192|3221950|Superiority or Other||Difference in proportions|4.4||||||95.0|-25.9|34.7||||||95% confidence interval in difference in success rate|
1752988|NCT00296192|3221950|Superiority or Other||Difference in proportions|0.0||||||95.0|-30.6|30.6||||||95% confidence interval in difference in success rate|
1752989|NCT00296192|3221950|Superiority or Other||Difference in proportions|4.4||||||95.0|-25.9|34.7||||||95% confidence interval in difference in success rate|
1752990|NCT00296192|3221950|Superiority or Other||Difference in proportions|-20.6||||||95.0|-53.3|12.1||||||95% confidence interval in difference in success rate|
1752991|NCT00296192|3221951|Superiority or Other||Mean Difference (Net)|-5.5|Standard Error of the Mean|8.9||||95.0|-23.3|12.2||||||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.|
1752992|NCT00296192|3221951|Superiority or Other||Mean Difference (Net)|-1.4|Standard Error of the Mean|8.45||||95.0|-18.2|15.4||||||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.|
1752993|NCT00296192|3221951|Superiority or Other||Mean Difference (Net)|-16.8|Standard Error of the Mean|8.63||||95.0|-34.0|0.4||||||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.|
1752994|NCT00296192|3221951|Superiority or Other||Mean Difference (Net)|-8.6|Standard Error of the Mean|8.58||||95.0|-25.7|8.5||||||Analysis of covariance modeling change from baseline to 34 minutes post-dose in tapping rate, controlling for treatment group and baseline value.|
1752995|NCT00296192|3221952|Superiority or Other||Mean Difference (Net)|-1.4|Standard Error of the Mean|3.02||||95.0|-7.4|4.6||||||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.|
1752996|NCT00296192|3221952|Superiority or Other||Mean Difference (Net)|2.9|Standard Error of the Mean|2.86||||95.0|-2.8|8.6||||||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.|
1752997|NCT00296192|3221952|Superiority or Other||Mean Difference (Net)|0.1|Standard Error of the Mean|2.93||||95.0|-5.7|6.0||||||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.|
1752998|NCT00296192|3221952|Superiority or Other||Mean Difference (Net)|2.9|Standard Error of the Mean|2.91||||95.0|-2.9|8.7||||||Analysis of covariance modeling change from baseline at 24 minutes post-dose in UPDRS Part III, controlling for treatment group and baseline value.|
1752999|NCT00296036|3221961|Superiority or Other|||||||0.768|||||||Fisher Exact||||
1753000|NCT00295750|3221984|Superiority or Other||Cumulative probability|85.9||||||95.0|79.9|90.2|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.||
1753001|NCT00295750|3221984|Superiority or Other||Cumulative probability|91.1||||||95.0|85.9|94.5|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.||
1753002|NCT00295750|3221984|Superiority or Other||Cumulative probability|85.8||||||95.0|79.8|90.1|||||95% confidence interval for the cumulative probability of completing the study without prostate specific antigen failure from Day 0 to Day 364.||
1753003|NCT00295750|3221985|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 28|
1753004|NCT00295750|3221985|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 28|
1753005|NCT00295750|3221985|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 14|
1753006|NCT00295750|3221985|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||Percentage change from baseline to Day 14|
1753007|NCT00295750|3221987|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1753008|NCT00295750|3221987|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1753009|NCT00295750|3221988|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1753010|NCT00295750|3221988|Superiority or Other||||||<|0.0001|||||||Fisher Exact||||
1753011|NCT00295750|3221989|Non-Inferiority or Equivalence|The non-inferiority limit was -10 percentage points.|Difference in cumulative probability|0.9||||||97.5|-3.2|5.0||||||A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364.|
1753012|NCT00295750|3221989|Non-Inferiority or Equivalence|The non-inferiority limit was -10 percentage points.|Difference in cumulative probability|1.9||||||97.5|-1.8|5.7||||||A non-inferiority assessment determined whether degarelix was non-inferior to leuprolide with respect to the cumulative probability of testosterone <=0.5 ng/mL from Day 28 to Day 364.|
1753013|NCT00295620|3221994|Superiority||Hazard Ratio (HR)|1.15||||0.531|2-Sided|95.0|0.75|1.77|||Log Rank|||Arm A: Anastrozole for 2 years Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of contralateral mammacarcinoma|
1753014|NCT00295620|3221995|Superiority||Hazard Ratio (HR)|1.06||||0.678|2-Sided|95.0|0.81|1.38|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of the occurrence of secondary carcinoma|
1753015|NCT00295620|3221996|Superiority||Hazard Ratio (HR)|1.35||||0.052|2-Sided|95.0|1.0|1.84|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a fracture|
1753016|NCT00295620|3221997|Superiority||Hazard Ratio (HR)|1.02||||0.867|2-Sided|95.0|0.83|1.25|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a death event|
1753017|NCT00295620|3221998|Superiority||Hazard Ratio (HR)|0.93||||0.425|2-Sided|95.0|0.79|1.11|||Log Rank|||Arm A: Anastrozole for 2 yerars Arm B: Anastrozole for 5 years Null hypothesis: there is no difference between the two treatment arms in the probability of a DFS event|
1753018|NCT00295061|3222010|Non-Inferiority or Equivalence|A total sample size of 20 subjects could demonstrate comparability of an AUC(0-7days) with 90% power up to a standard deviation of 0.288 of the difference in the log scale, expected mean treatment difference of 0 (= ratio of 1), a lower equivalence limit of –0.223 (= log 0.8), upper limit of 0.223 (= log 1.25) and a one-sided alpha of 0.05 (90% CI).|Geometric least square means ratio|1.03||||||90.0|0.97|1.09||||||To compare AUC 0-7 days between the two treatments (Alpha-1 MP vs. Prolastin),natural log-transformed AUC 0-7 days values were analyzed by analysis of variance (ANOVA).|
1753019|NCT00295022|3222036|Superiority or Other||Median Difference (Final Values)|-2.19|||<|0.001|2-Sided|95.0|-3.43|-0.95|||ANCOVA||||
1755489|NCT00265616|3225327|Superiority or Other|||||||1|||||||Fisher Exact||||
1753022|NCT00294723|3222047|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-3.48||||0.2088||95.0|-8.9|1.95||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1753023|NCT00294723|3222047|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|0.43||||0.8765||95.0|-5.05|5.92||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1753024|NCT00294723|3222047|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.04||||0.2749||95.0|-8.51|2.42||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1753025|NCT00294723|3222048|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-3.48||||0.2089||95.0|-8.91|1.95||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1753026|NCT00294723|3222048|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-0.33||||0.906||95.0|-5.82|5.16||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1753027|NCT00294723|3222048|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.81||||0.172||95.0|-9.28|1.66||2-sided significance level 5%|ANCOVA|||Change in prandial increments of plasma glucose from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1753028|NCT00294723|3222049|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-1.2||||0.6639||95.0|-6.5|4.1||2-sided significance level 5%|ANCOVA|||Change in postprandial (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1753029|NCT00294723|3222049|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.9||||0.2968||95.0|-8.3|2.5||2-sided significance level 5%|ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1753030|NCT00294723|3222049|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-4.0||||0.1396||95.0|-9.4|1.3||2-sided significance level 5%|ANCOVA|||Change in mean prandial increments of plasma glucose from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.|
1753031|NCT00294723|3222050|Non-Inferiority or Equivalence|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg - liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.28||||0.0123||95.0|-0.49|-0.06||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.|
1753042|NCT00294723|3222053|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-12.9||||0.0038||95.0|-21.6|-4.2||2-sided significance level 5%|ANCOVA|||Change in mean postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.|
1754303|NCT00281658|3223908|Superiority or Other (legacy)||Odds Ratio (OR)|2.34||||||95.0|1.54|3.58|||||||
1753032|NCT00294723|3222050|Non-Inferiority or Equivalence|The two-sided 95% confidence interval (CI) for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.28||||0.0122||95.0|-0.49|-0.06||The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.|
1753033|NCT00294723|3222050|Non-Inferiority or Equivalence|The two-sided 95% confidence interval (CI) for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete CI was below 0%.|Estimated treatment difference, LS Mean|-0.55|||<|0.0001||95.0|-0.77|-0.34||The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity. 2-sided significance level was 5%.|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.|
1753034|NCT00294723|3222051|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-9.15||||0.0553||95.0|-18.51|0.21||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.|
1753035|NCT00294723|3222051|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-1.83||||0.7047||95.0|-11.33|7.66||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.|
1753036|NCT00294723|3222051|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-10.98||||0.0227||95.0|-20.42|-1.54||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.|
1753037|NCT00294723|3222052|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-9.81||||0.0392||95.0|-19.14|-0.49||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.|
1753038|NCT00294723|3222052|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.49||||0.606||95.0|-11.95|6.98||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.|
1753039|NCT00294723|3222052|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-12.3||||0.0105||95.0|-21.71|-2.89||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.|
1753040|NCT00294723|3222053|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-6.6||||0.1319||95.0|-15.3|2.0||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.|
1753041|NCT00294723|3222053|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-6.3||||0.1616||95.0|-15.0|2.5||2-sided significance level 5%|ANCOVA|||Change in postprandial glucose (PPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline PPG as covariate.|
1753089|NCT00294515|3222134|Superiority or Other||Odds Ratio (OR)|0.37||||0.0001||95.0|0.22|0.6|||Cochran-Mantel-Haenszel|Stratified by Center Pools|||
1753090|NCT00294515|3222135|Superiority or Other||Odds Ratio (OR)|0.2|||<|0.0001||95.0|0.11|0.37|||Cochran-Mantel-Haenszel|Stratified by Center Pools|||
1753043|NCT00294723|3222054|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-6.6||||0.1789||95.0|-16.24|3.03||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.|
1753044|NCT00294723|3222054|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-10.02||||0.0395||95.0|-19.56|-0.49||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.|
1753045|NCT00294723|3222054|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-16.63||||0.0007||95.0|-26.19|-7.06||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.|
1753046|NCT00294723|3222055|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg|Estimated treatment difference, LS Mean|-6.46||||0.1942||95.0|-16.23|3.3||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.|
1753047|NCT00294723|3222055|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-11.33||||0.0217||95.0|-20.99|-1.66||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.|
1753048|NCT00294723|3222055|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-17.79||||0.0003||95.0|-27.48|-8.09||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.|
1753049|NCT00294723|3222056|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-10.36||||0.0223||95.0|-19.24|-1.48||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.|
1753050|NCT00294723|3222056|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-9.92||||0.027||95.0|-18.7|-1.12||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.|
1753051|NCT00294723|3222056|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 mg/dL, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-20.28|||<|0.0001||95.0|-29.09|-11.46||2-sided significance level 5%|ANCOVA|||Change in fasting plasma glucose (FPG) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline FPG as covariate.|
1753052|NCT00294723|3222057|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.75||||0.0642||95.0|-1.55|0.05||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariance.|
1753053|NCT00294723|3222057|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.72|||<|0.0001||95.0|-3.52|-1.93||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1753091|NCT00294515|3222136|Superiority or Other||Odds Ratio (OR)|0.4|||<=|0|2-Sided|95.0|0.25|0.66|||Cochran-Mantel-Haenszel|Stratified by Center Pools|||
1753092|NCT00294398|3222138|Superiority or Other|||||||0.87|||||||t-test, 2 sided||||
1753054|NCT00294723|3222057|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.48|||<|0.0001||95.0|-4.28|-2.68||2-sided significance level was 5%.|ANCOVA|||Change in body weight from baseline to end of treatment at 156 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country, and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1753055|NCT00294723|3222058|Non-Inferiority or Equivalence|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg – liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.29||||0.0129||95.0|-0.52|-0.06||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.|
1753056|NCT00294723|3222058|Non-Inferiority or Equivalence|The two sided 95% CI for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.31||||0.0076||95.0|-0.54|-0.08||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.|
1753057|NCT00294723|3222058|Non-Inferiority or Equivalence|The two sided 95% confidence interval for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.6|||<|0.0001||95.0|-0.83|-0.38||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.|
1753058|NCT00294723|3222059|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.8||||0.0462||95.0|-1.59|-0.01||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1753059|NCT00294723|3222059|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-2.84|||<|0.0001||95.0|-3.63|-2.06||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1753060|NCT00294723|3222059|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.65|||<|0.0001||95.0|-4.44|-2.86||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 104 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1753061|NCT00294723|3222060|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and liraglutide 1.2 mg was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the liraglutide 1.8 mg was better than liraglutide 1.2 mg.|Estimated treatment difference, LS Mean|-0.41||||0.2584||95.0|-1.11|0.3||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1753062|NCT00294723|3222060|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.17|||<|0.0001||95.0|-3.87|-2.47||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1753063|NCT00294723|3222060|Non-Inferiority or Equivalence|A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg and glimepiride was calculated. If the upper limit of the 95% CI was below 0 kg, it was concluded that the given dose of liraglutide was better than glimepiride.|Estimated treatment difference, LS Mean|-3.58|||<|0.0001||95.0|-4.28|-2.87||2-sided significance level 5%|ANCOVA|||Change in body weight from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.|
1753093|NCT00293813|3222192|Superiority or Other||Mean Difference (Final Values)|1.0||||||95.0|-0.6|2.6|||||||
1753094|NCT00293813|3222192|Superiority or Other||Mean Difference (Final Values)|4.1||||||95.0|2.6|5.7|||||||
1753064|NCT00294723|3222061|Non-Inferiority or Equivalence|A test for superiority of liraglutide 1.8 mg to liraglutide 1.2 mg was performed to compare the two doses. Superiority of liraglutide 1.8 mg was concluded if the upper limit of the 2-sided 95% CI for the treatment difference (liraglutide 1.8 mg – liraglutide 1.2 mg) was below 0%.|Estimated treatment difference, LS Mean|-0.29||||0.0046||95.0|-0.5|-0.09||2-sided significance level 5%|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.|
1753065|NCT00294723|3222061|Non-Inferiority or Equivalence|The two sided 95% confidence interval for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%. Superiority of 1.2 mg liraglutide was only tested if 1.2 mg liraglutide was non-inferior to glimepiride and 1.8 mg liraglutide was superior to glimepiride.|Estimated treatment difference, LS Mean|-0.33||||0.0014||95.0|-0.53|-0.13||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.|
1753066|NCT00294723|3222061|Non-Inferiority or Equivalence|The two sided 95% confidence interval for the treatment difference [liraglutide - glimepiride] was estimated. Liraglutide was shown to be non-inferior to glimepiride if the upper limit of the two-sided 95% CI for the treatment difference was below 0.4% and superior if the complete confidence interval was below 0%.|Estimated treatment difference, LS Mean|-0.62|||<|0.0001||95.0|-0.83|-0.42||"The statistical analysis of the primary endpoint was done in a hierarchal manner due to multiple comparisons. No other adjustments were made for multiplicity.~2-sided significance level 5%"|ANCOVA|||Change in glycosylated haemoglobin (HbA1c) from baseline to end of treatment at 52 weeks was analysed using an analysis of covariance (ANCOVA) model with treatment, country and previous oral antidiabetic drug (OAD) treatment as fixed effects and baseline HbA1c as covariate.|
1753067|NCT00294684|3222070|Superiority or Other (legacy)||Risk Ratio (RR)|0.3||||0.29|2-Sided|95.0|0.03|2.92|||Log Binomial||||
1753068|NCT00294684|3222071|Superiority or Other (legacy)||Risk Ratio (RR)|1.4||||0.41|2-Sided|95.0|0.62|3.14|||Log Binomial||||
1753069|NCT00294684|3222072|Superiority or Other (legacy)|||||||0.2801|||||||Mixed Models Analysis||||
1753070|NCT00294684|3222073|Superiority or Other (legacy)|||||||0.1603|||||||Mixed Models Analysis||||
1753071|NCT00294684|3222074|Superiority or Other (legacy)||Mean Difference (Net)|-0.39||||0.6607||95.0|-2.16|1.38|||Mixed Models Analysis|||LS Mean difference of steroid minus placebo (negative values indicate larger average bilirubin in placebo)|
1753072|NCT00294684|3222075|Superiority or Other (legacy)||Mean Difference (Net)|-2.3||||0.0552|2-Sided|95.0|-4.65|0.05|||Mixed Models Analysis|||LS Mean difference of steroid minus placebo (negative values indicate larger average values of bilirubin in placebo)|
1753073|NCT00294684|3222076|Superiority or Other (legacy)||Mean Difference (Net)|-1.6||||0.0973|2-Sided|95.0|-3.49|0.3|||Mixed Models Analysis|||LS Mean difference reported as steroid minus placebo (negative values mean larger average values of total bilirubin in placebo).|
1753074|NCT00294684|3222077|Superiority or Other (legacy)||Hazard Ratio (HR)|1.0||||0.99|2-Sided|95.0|0.6|1.8|||Regression, Cox||||
1753075|NCT00294684|3222078|Superiority or Other (legacy)||Risk Ratio (RR)|1.14||||0.43|2-Sided|95.0|0.83|1.57|||Log binomial|||RR greater than one indicates benefit of steriods and a P value of treatment success from a log-binomial model with these covariates: Treatment group, age a HPE, BASM as fixed effects, and site as a random effect.|
1753076|NCT00294671|3222079|Superiority or Other|||||||0.37|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 mental component change from baseline to 1 year.|
1753077|NCT00294671|3222079|Superiority or Other|||||||0.06|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 mental component change from baseline to 2 years.|
1753078|NCT00294671|3222080|Superiority or Other|||||||0.06|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 physical component change from baseline to 1 year.|
1753079|NCT00294671|3222080|Superiority or Other|||||||0.001|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in SF-36 physical component change from baseline to 2 years.|
1753080|NCT00294671|3222081|Superiority or Other|||||||0.43|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in mBMI change from baseline to 1 year.|
1753081|NCT00294671|3222081|Superiority or Other|||||||0.21|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in mBMI change from baseline to 2 years.|
1753082|NCT00294671|3222082|Superiority or Other|||||||0.1|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in Kumamoto score change from baseline to 1 year.|
1753083|NCT00294671|3222082|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in Kumamoto score change from baseline to 2 years.|
1753084|NCT00294671|3222083|Superiority or Other|||||||0.02|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in NIS+7 change from baseline to 1years.|
1753085|NCT00294671|3222083|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Longitudinal analysis of the difference between placebo and diflunisal treatment groups in NIS+7 change from baseline to 2 years.|
1753086|NCT00294645|3222126|Superiority or Other||||||<|0.0001|||||||Modified Peto-Peto|A one-sided test was used.||Null hypothesis: control rate = remote rate|
1753087|NCT00294515|3222132|Superiority or Other||Odds Ratio (OR)|0.55||||0.01||95.0|0.34|0.86|||Cochran-Mantel-Haenszel|Stratified by Center Pools|||
1753088|NCT00294515|3222133|Superiority or Other||Odds Ratio (OR)|0.56||||0.0126||95.0|0.35|0.88|||Cochran-Mantel-Haenszel|Stratified by Center Pools|||
1753095|NCT00293462|3222220|Superiority or Other|||||||0.22||||||0.22 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.|||
1753096|NCT00293462|3222221|Superiority or Other|||||||0.78||||||0.78 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.|||
1753097|NCT00293462|3222222|Superiority or Other|||||||0.28||||||0.28 (quadratic)|Mixed Models Analysis|Restricted Maximum Likelihood Methods with random intercepts was the only model used for the three groups and seven measurement time points.||Multilevel regression was used.|
1753098|NCT00293462|3222223|Superiority or Other|||||||0.92|||||||Mantel Haenszel|Log rank, breslow, tarone-ware, but use mantel cox log rank for this analysis||Kaplan-Meier estimate of the survival curves used information from subjects who develop mucositis to the healing of the mucositis in three groups, Group GG, SG and SS. In order to compare the three curves that were created, the Mantel-Haenszel log-rank statistic was used|
1753099|NCT00293462|3222224|Superiority or Other|||||||0.09|||||||Fisher Exact|Two by two table was used. One cell had expected frequency test less than five, so Fisher’s exact two-tailed test was used.||Fisher's exact two tailed test|
1753100|NCT00293384|3222232|Superiority or Other||proportion|0.06|||||2-Sided||||||||||
1753101|NCT00293384|3222234|Superiority or Other||proportion|0.63|||||||||||||||
1753102|NCT00293384|3222235|Superiority or Other||proportion|0.57||||0.1|2-Sided|||||85% statistical power|Simon optimal design|||Optimal Simon design for phase II study. p0=45% p1=65%.|
1753103|NCT00293241|3222286|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1753104|NCT00293241|3222287|Superiority or Other|||||||1|||||||Fisher Exact|||No Symptoms (24 Months)|
1753105|NCT00293241|3222287|Superiority or Other|||||||0.92|||||||Fisher Exact|||No Symptoms (12 months)|
1753106|NCT00293241|3222287|Superiority or Other|||||||0.24|||||||Fisher Exact|||No Symptoms (Baseline)|
1753107|NCT00293241|3222288|Superiority or Other|||||||0.29|||||||Wilcoxon (Mann-Whitney)|||H0:Change in P-wave duration=Change in P-wave duration Ha:Change in P-wave duration≠Change in P-wave duration|
1753108|NCT00293241|3222288|Superiority or Other|||||||0.19|||||||Wilcoxon (Mann-Whitney)|||H0:Change in QRS duration=Change in QRS duration Ha:Change in QRS duration≠Change in QRS duration|
1753109|NCT00293241|3222288|Superiority or Other|||||||0.34|||||||Wilcoxon (Mann-Whitney)|||H0:Change in P-R interval=Change in P-R interval Ha:Change in P-R interval≠Change in P-R interval|
1753110|NCT00293241|3222291|Superiority or Other|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||Statistical test for Number of subjects with CV hospitalization|
1753111|NCT00293241|3222292|Superiority or Other||Hazard Ratio (HR)|0.492||||0.24|2-Sided|95.0|0.148|1.637|||Log Rank||||
1753112|NCT00293241|3222293|Superiority or Other||Hazard Ratio (HR)|1.243||||0.33|2-Sided|95.0|0.803|1.923|||Log Rank|||"Analysis:Time to all-cause death~H0:survival MVP ON=survival MVP OFF Ha:survival MVP ON≠survival MVP OFF"|
1753113|NCT00293241|3222295|Superiority or Other|||||||0.53|||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Antiarrhythmic drug=Change in Antiarrhythmic drug Ha:Change in Antiarrhythmic drug≠Change in Antiarrhythmic drug|
1753114|NCT00293241|3222295|Superiority or Other|||||||0.55|||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Calcium antagonists=Change in Calcium antagonists Ha:Change in Calcium antagonists≠Change in Calcium antagonists|
1753115|NCT00293241|3222295|Superiority or Other|||||||0.65|||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Digitalis/digoxin=Change in Digitalis/digoxin Ha:Change in Digitalis/digoxin≠Change in Digitalis/digoxin|
1753116|NCT00293241|3222295|Superiority or Other|||||||0.34|||||||Regression, Logistic|||Analysis:Repeated measures logistic regression H0:Change in Beta-blockers=Change in Beta-blockers Ha:Change in Beta-blockers≠Change in Beta-blockers|
1753117|NCT00293241|3222296|Superiority or Other|||||||0.78|||||||Repeated measures logistic regression|||Analysis:Repeated measures logistic regression|
1753118|NCT00293241|3222298|Superiority or Other|||||||0.048|||||||Regression, Linear||||
1753119|NCT00293241|3222299|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||"Analysis:Wilcoxon Test for Comparison of Percentage of Ventricular Pacing (%VP) During Followup by Randomization Arm~H0:distribution %VP MVP=distribution %VP DDD~Ha:distribution %VP MVP≠distribution %VP DDD~Ha:"|
1753120|NCT00293241|3222300|Superiority or Other||Hazard Ratio (HR)|1.425||||0.44|2-Sided|95.0|0.573|3.543|||Log Rank|||Analysis:Time to permanent AF H0:freedom from permanent AF=freedom from permanent AF Ha:freedom from permanent AF≠freedom from permanent AF|
1753121|NCT00293241|3222301|Superiority or Other||Hazard Ratio (HR)|1.521||||0.08|2-Sided|95.0|0.954|2.424|||Log Rank|||Analysis:Time to first persistent AT/AF H0:freedom from persistent AT/AF=freedom from persistent AT/AF Ha:freedom from persistent AT/AF≠freedom from persistent AT/AF|
1753122|NCT00293241|3222302|Superiority or Other||Hazard Ratio (HR)|1.127||||0.48|2-Sided|95.0|0.808|1.57|||Log Rank|||"Analysis:Time to first all cause death or cardiovascular hospitalization~H0:freedom from death or CV hospitalization=freedom from death or CV hospitalization~Ha:freedom from death or CV hospitalization≠freedom from death or CV hospitalization"|
1753123|NCT00293241|3222303|Superiority or Other||Hazard Ratio (HR)|0.927||||0.72|2-Sided|95.0|0.612|1.405|||Log Rank||"Hospitalization:hospital admission with overnight stay;ER/office visits with cardioversions;acute treatment of worsened cardiac condition~CV:new/worsening HF,angina,MI,arrhythmia,stroke, TIA,acute peripheral vascular emergencies,pulmonary embolism"|"Analysis:Time to first cardiovascular hospitalization (CV hosp)~H0:freedom from CV hosp MVP=freedom from CV hosp DDD (dual chamber conventional pacing)~Ha:freedom from CV hosp MVP≠freedom from CV hosp DDD~Power calculation:~The study is designed to detect a difference event-free survival after 2 years of 5.5 % absolute, going from 91.5% to 97%.~Test=two-sided alpha=0.05 power=80% 1:1 randomization n=600"|
1753124|NCT00293059|3222357|Superiority or Other||||||<|0.0001|||||||inverting 2 one-sided tests||||
1753125|NCT00293033|3222358|Superiority or Other (legacy)||Mean Difference (Final Values)|46.88|Standard Error of the Mean|18.46||0.015|2-Sided|95.0|10.69|83.08|||Mixed Models Analysis||||
1754304|NCT00281658|3223909|Superiority or Other (legacy)||Odds Ratio (OR)|2.3||||||95.0|1.54|3.47|||||||
1753126|NCT00293033|3222359|Superiority or Other (legacy)||Mean Difference (Final Values)|33.26|Standard Error of the Mean|12.72||0.012|2-Sided|95.0|8.32|58.2|||Mixed Models Analysis||||
1753127|NCT00293033|3222360|Superiority or Other (legacy)||Mean Difference (Final Values)|19.84|Standard Error of the Mean|7.25||0.009|2-Sided|95.0|5.63|34.04|||Mixed Models Analysis||||
1753128|NCT00293033|3222361|Superiority or Other (legacy)||Mean Difference (Final Values)|5.96|Standard Error of the Mean|2.57||0.023|2-Sided|95.0|0.92|11.01|||Mixed Models Analysis||||
1753129|NCT00293033|3222362|Superiority or Other (legacy)|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1753130|NCT00293033|3222363|Superiority or Other (legacy)|||||||0.007|||||||Wilcoxon (Mann-Whitney)||||
1753131|NCT00293033|3222364|Superiority or Other (legacy)|||||||0.131|||||||Wilcoxon (Mann-Whitney)||||
1753132|NCT00293033|3222365|Superiority or Other (legacy)|||||||0.032|||||||Wilcoxon (Mann-Whitney)||||
1753133|NCT00293033|3222366|Superiority or Other (legacy)|||||||0.75|||||||Wilcoxon (Mann-Whitney)||||
1753134|NCT00293033|3222367|Superiority or Other (legacy)|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1753135|NCT00293033|3222368|Superiority or Other (legacy)|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1753136|NCT00293033|3222369|Superiority or Other (legacy)||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1753137|NCT00293033|3222370|Superiority or Other (legacy)|||||||0.004|||||||Wilcoxon (Mann-Whitney)||||
1753138|NCT00293033|3222371|Superiority or Other (legacy)|||||||0.009|||||||Wilcoxon (Mann-Whitney)||||
1753139|NCT00293033|3222372|Superiority or Other (legacy)|||||||0.1|||||||Wilcoxon (Mann-Whitney)||||
1753140|NCT00293033|3222373|Superiority or Other (legacy)|||||||0.005|||||||Wilcoxon (Mann-Whitney)||||
1753141|NCT00293033|3222374|Superiority or Other (legacy)|||||||0.008|||||||Wilcoxon (Mann-Whitney)||||
1753142|NCT00293033|3222375|Superiority or Other (legacy)|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1753143|NCT00293033|3222376|Superiority or Other (legacy)|||||||0.963|||||||Wilcoxon (Mann-Whitney)||||
1753144|NCT00293033|3222377|Superiority or Other (legacy)|||||||0.031|||||||Wilcoxon (Mann-Whitney)||||
1753145|NCT00293033|3222378|Superiority or Other (legacy)|||||||0.077|||||||Wilcoxon (Mann-Whitney)||||
1753146|NCT00293033|3222379|Superiority or Other (legacy)|||||||0.498|||||||Wilcoxon (Mann-Whitney)||||
1753147|NCT00293033|3222380|Superiority or Other (legacy)|||||||0.563|||||||Wilcoxon (Mann-Whitney)||||
1753148|NCT00293033|3222381|Superiority or Other (legacy)|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1753149|NCT00293033|3222382|Superiority or Other (legacy)|||||||1|||||||Wilcoxon (Mann-Whitney)||||
1753150|NCT00293033|3222383|Superiority or Other (legacy)||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1753151|NCT00293033|3222384|Superiority or Other (legacy)|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1753152|NCT00293033|3222385|Superiority or Other (legacy)|||||||0.005|||||||Wilcoxon (Mann-Whitney)||||
1753153|NCT00293033|3222386|Superiority or Other (legacy)|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1753154|NCT00293033|3222387|Superiority or Other (legacy)|||||||0.062|||||||Wilcoxon (Mann-Whitney)||||
1753155|NCT00293033|3222388|Superiority or Other (legacy)|||||||0.278|||||||Wilcoxon (Mann-Whitney)||||
1753156|NCT00293033|3222389|Superiority or Other (legacy)|||||||0.157|||||||Wilcoxon (Mann-Whitney)||||
1753157|NCT00293033|3222390|Superiority or Other (legacy)||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1753158|NCT00293033|3222391|Superiority or Other (legacy)|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1753159|NCT00293033|3222392|Superiority or Other (legacy)|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1753160|NCT00293033|3222393|Superiority or Other (legacy)|||||||0.192|||||||Wilcoxon (Mann-Whitney)||||
1753161|NCT00293033|3222394|Superiority or Other (legacy)|||||||0.113|||||||Wilcoxon (Mann-Whitney)||||
1753162|NCT00293033|3222395|Superiority or Other (legacy)|||||||0.193|||||||Wilcoxon (Mann-Whitney)||||
1753163|NCT00293033|3222396|Superiority or Other (legacy)||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1753164|NCT00293033|3222397|Superiority or Other (legacy)|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1753165|NCT00293033|3222398|Superiority or Other (legacy)|||||||0.015|||||||Wilcoxon (Mann-Whitney)||||
1753166|NCT00293033|3222399|Superiority or Other (legacy)|||||||0.223|||||||Wilcoxon (Mann-Whitney)||||
1753167|NCT00293033|3222400|Superiority or Other (legacy)|||||||0.458|||||||Wilcoxon (Mann-Whitney)||||
1753168|NCT00293033|3222401|Superiority or Other (legacy)|||||||0.517|||||||Wilcoxon (Mann-Whitney)||||
1753169|NCT00293033|3222402|Superiority or Other (legacy)||Mean Difference (Final Values)|31.98|Standard Error of the Mean|8.23|<|0.001|2-Sided|95.0|15.85|48.12|||Mixed Models Analysis||||
1753170|NCT00293033|3222403|Superiority or Other (legacy)||Mean Difference (Final Values)|19.68|Standard Error of the Mean|5.7|<|0.001|2-Sided|95.0|8.5|30.86|||Mixed Models Analysis||||
1753171|NCT00293033|3222404|Superiority or Other (legacy)||Mean Difference (Final Values)|2.32|Standard Error of the Mean|1.16||0.047|2-Sided|95.0|0.04|4.61|||Mixed Models Analysis||||
1753172|NCT00293033|3222405|Superiority or Other (legacy)||Mean Difference (Final Values)|0.94|Standard Error of the Mean|0.7||0.179|2-Sided|95.0|-0.44|2.33|||Mixed Models Analysis||||
1753173|NCT00293033|3222406|Superiority or Other (legacy)||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.33||0.44|2-Sided|95.0|-0.4|0.91|||Wilcoxon (Mann-Whitney)||||
1753174|NCT00293033|3222407|Superiority or Other (legacy)||Mean Difference (Final Values)|9.74|Standard Error of the Mean|3.28||0.004|2-Sided|95.0|3.31|16.18|||Mixed Models Analysis|The SPID was analyzed using a mixed model of repeated measures with fixed effects for treatment, pooled site, and a random effect for subjects.|Onsolis minus placebo||
1753175|NCT00292461|3222422|Superiority or Other|||||||0.86|||||||Cochran-Mantel-Haenszel||||
1753176|NCT00292461|3222423|Superiority or Other|||||||0.079|||||||Cochran-Mantel-Haenszel||||
1753177|NCT00292461|3222424|Superiority or Other|||||||0.46|||||||Cochran-Mantel-Haenszel||||
1753178|NCT00292461|3222425|Superiority or Other|||||||0.24|||||||ANOVA||||
1753179|NCT00292370|3222434|Superiority or Other (legacy)||||||<|0.05|||||||Mixed Models Analysis||||
1753180|NCT00292227|3222437|Superiority or Other||Mean Difference (Net)|6.19||||||95.0|4.94|7.45|||||The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.|
1753181|NCT00292227|3222438|Superiority or Other||Mean Difference (Net)|7.58||||||95.0|6.21|8.95|||||The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.|
1753182|NCT00292227|3222439|Superiority or Other||Mean Difference (Net)|7.52||||||95.0|6.31|8.72|||||The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.|
1753183|NCT00292227|3222440|Superiority or Other||Mean Difference (Net)|8.6||||||95.0|7.25|9.96|||||The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.|
1753184|NCT00292227|3222441|Superiority or Other||Mean Difference (Net)|8.87||||||95.0|7.47|10.28|||||The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.|
1753185|NCT00292227|3222442|Superiority or Other||Mean Difference (Net)|9.3||||||95.0|7.57|11.02|||||The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.|
1753186|NCT00292227|3222443|Superiority or Other||Mean Difference (Net)|8.28||||||95.0|6.85|9.7|||||The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.|
1753187|NCT00292227|3222444|Superiority or Other||Mean Difference (Net)|11.3||||||95.0|9.94|12.67|||||The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.|
1753188|NCT00292227|3222445|Superiority or Other||Mean Difference (Net)|11.02||||||95.0|9.12|12.93|||||The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.|
1753189|NCT00292227|3222446|Superiority or Other||Mean Difference (Net)|13.5||||||95.0|11.78|15.22|||||The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.|
1753190|NCT00292227|3222447|Superiority or Other||Mean Difference (Net)|1.51||||||95.0|0.3|2.73|||||The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.|
1753191|NCT00292227|3222448|Superiority or Other||Mean Difference (Net)|0.48||||||95.0|-0.72|1.68|||||The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.|
1753192|NCT00292227|3222449|Superiority or Other||Mean Difference (Net)|0.34||||||95.0|-1.04|1.71|||||The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.|For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.|
1753463|NCT00289198|3222969|Superiority or Other||Mean Difference (Final Values)|-0.412|||<|0.001|2-Sided|95.0|-0.54|-0.28|||ANCOVA|||Sneezing score, Placebo vs Fluticasone furoate|
1753193|NCT00292227|3222450|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.42||||||90.0|-2.33|1.5|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753194|NCT00292227|3222451|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.8||||||90.0|-1.14|2.73|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753195|NCT00292227|3222452|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.17||||||90.0|-0.69|3.03|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753196|NCT00292227|3222453|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.68||||||90.0|-2.6|1.25|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753197|NCT00292227|3222454|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.37||||||90.0|-2.13|1.39|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753198|NCT00292227|3222455|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.81||||||90.0|-2.55|0.93|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753199|NCT00292227|3222456|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.62||||||90.0|-3.87|0.63|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753200|NCT00292227|3222457|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.23||||||90.0|-2.99|0.53|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753201|NCT00292227|3222458|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.21||||||90.0|-1.76|2.17|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753202|NCT00292227|3222459|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.5||||||90.0|-2.34|1.35|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753233|NCT00292188|3222496|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|0.22||0.009||95.0|-1.03|-0.15|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 6: FAS|
1753234|NCT00292188|3222496|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.22||0.041||95.0|-0.9|-0.02|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 5: FAS|
1753203|NCT00292227|3222460|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.41||||||90.0|-2.3|1.49|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753204|NCT00292227|3222461|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.53||||||90.0|-2.37|1.3|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753205|NCT00292227|3222462|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.21||||||90.0|-1.78|1.36|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753206|NCT00292227|3222463|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.65||||||90.0|-0.65|3.96|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753207|NCT00292227|3222464|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.31||||||90.0|-1.7|2.32|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753208|NCT00292227|3222465|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|1.69||||||90.0|-0.34|3.73|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753209|NCT00292227|3222466|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-1.17||||||90.0|-3.25|0.91|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753210|NCT00292227|3222467|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.26||||||90.0|-2.29|1.78|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753211|NCT00292227|3222468|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.56||||||90.0|-2.84|1.72|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753212|NCT00292227|3222469|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.07||||||90.0|-2.14|2.28|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753235|NCT00292188|3222496|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.21||0.137||95.0|-0.74|0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 4: FAS|
1753236|NCT00292188|3222496|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.2||0.01||95.0|-0.93|-0.13|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 3: FAS|
1753213|NCT00292227|3222470|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.11||||||90.0|-2.25|2.02|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753214|NCT00292227|3222471|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.26||||||90.0|-1.8|2.32|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753215|NCT00292227|3222472|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|0.84||||||90.0|-1.12|2.8|||||The direction of the estimate is Rotigotine - Placebo Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753216|NCT00292227|3222473|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.01||||||90.0|-2.21|2.19|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753217|NCT00292227|3222474|Non-Inferiority or Equivalence|A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).|Mean Difference (Net)|-0.75||||||90.0|-2.63|1.12|||||The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.|The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.|
1753218|NCT00292188|3222484|Superiority or Other||Mean Difference (Final Values)|-3.84|Standard Error of the Mean|2.25||0.09||95.0|-8.28|0.61|||ANCOVA||||
1753219|NCT00292188|3222492|Superiority or Other||Odds Ratio (OR)|1.42||||0.267||95.0|0.76|2.64|||Regression, Logistic|Logistic regression adjusted for treatment group, baseline score and pooled country.|||
1753220|NCT00292188|3222493|Superiority or Other||Mean Difference (Final Values)|-7.54|Standard Error of the Mean|2.02||0||95.0|-11.52|-3.56|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Problems Index-9|
1753221|NCT00292188|3222493|Superiority or Other||Mean Difference (Final Values)|-9.52|Standard Error of the Mean|2.63||0||95.0|-14.71|-4.33|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Problems Index-6|
1753222|NCT00292188|3222493|Superiority or Other||Mean Difference (Final Values)|2.31|Standard Error of the Mean|2.34||0.324||95.0|-2.3|6.92|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Somnolence|
1753223|NCT00292188|3222493|Superiority or Other||Mean Difference (Final Values)|10.63|Standard Error of the Mean|3.27||0.001||95.0|4.19|17.07|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Adequacy|
1753224|NCT00292188|3222493|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.42||0.846||95.0|-0.92|0.76|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Quantity|
1753225|NCT00292188|3222493|Superiority or Other||Mean Difference (Final Values)|-5.95|Standard Error of the Mean|2.88||0.04||95.0|-11.62|-0.28|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Awaken Short of Breath/Headache|
1753226|NCT00292188|3222493|Superiority or Other||Mean Difference (Final Values)|1.05|Standard Error of the Mean|2.71||0.7||95.0|-4.3|6.4|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Snoring|
1753227|NCT00292188|3222493|Superiority or Other||Mean Difference (Final Values)|-10.72|Standard Error of the Mean|2.62||0||95.0|-15.89|-5.55|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.||Sleep Disturbance|
1753228|NCT00292188|3222494|Superiority or Other||Mean Difference (Final Values)|-0.79|Standard Error of the Mean|0.23||0.001||95.0|-1.25|-0.34|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.|||
1753229|NCT00292188|3222495|Superiority or Other||Odds Ratio (OR)|1.78||||0.088||95.0|0.92|3.46|||Regression, Logistic|logstic regression adjusted for treatment group, baseline pain score and pooled country.||50% responder|
1753230|NCT00292188|3222495|Superiority or Other||Odds Ratio (OR)|1.84||||0.032||95.0|1.05|3.21|||Regression, Logistic|logstic regression adjusted for treatment group, baseline pain score and pooled country.||30% responder|
1753231|NCT00292188|3222496|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.25||0.019||95.0|-1.1|-0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 8: FAS|
1753232|NCT00292188|3222496|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.25||0.035||95.0|-1.01|-0.04|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 7: FAS|
1753546|NCT00286754|3223201|Superiority or Other|||||||0.88||||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Wilcoxon (Mann-Whitney)||||
1753237|NCT00292188|3222496|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.18||0.15||95.0|-0.62|0.1|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 2: FAS|
1753238|NCT00292188|3222496|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.15||0.099||95.0|-0.56|0.05|||Mixed Models Analysis|Repeated Measures Mixed Models. Adjusted for treatment, week, baseline pain score, pooled country and treatment-week.||Week 1|
1753239|NCT00292188|3222497|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|1.03||0.819||95.0|-1.87|2.34|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.|||
1753240|NCT00292188|3222498|Superiority or Other||Mean Difference (Final Values)|-1.68|Standard Error of the Mean|1.0||0.099||95.0|-3.69|0.32|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.|||
1753241|NCT00292188|3222499|Superiority or Other||Mean Difference (Final Values)|-0.97|Standard Error of the Mean|0.32||0.003||95.0|-1.61|-0.33|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.|||
1753242|NCT00292188|3222500|Superiority or Other||Mean Difference (Final Values)|-0.84|Standard Error of the Mean|0.39||0.031||95.0|-1.6|-0.08|||ANCOVA|ANCOVA adjusted for treatment group, baseline score and pooled country.|||
1753243|NCT00292188|3222501|Superiority or Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.24||0.01||95.0|-1.09|-0.15|||ANCOVA|ANCOVA adjusted for treatment group, baseline mean pain score and pooled country||The study is powered to detect a clinically significant difference of 1 between treatment groups in the weekly mean pain score. Null hypothesis was that there was no difference in weekly mean pain scores between pregabalin and placebo.|
1753244|NCT00291694|3222517|Superiority or Other|||||||0.37||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)||||
1753245|NCT00291694|3222518|Superiority or Other|||||||0.39||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)||||
1753246|NCT00291694|3222519|Superiority or Other|||||||0.37||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)||||
1753247|NCT00291694|3222520|Superiority or Other|||||||0.053||||||Not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||Difference between groups, two-sided. Endpoint not specifically powered for effect.|
1753248|NCT00291694|3222521|Superiority or Other|||||||0.71|||||||Wilcoxon (Mann-Whitney)||||
1753249|NCT00291642|3222532|Superiority or Other||Mean Difference (Final Values)|-3.74|Standard Error of the Mean|0.637|<|0.001|2-Sided|95.0|-4.99|-2.49|||ANCOVA||||
1753250|NCT00291642|3222532|Superiority or Other||Mean Difference (Final Values)|-4.13|Standard Error of the Mean|0.637|<|0.001|2-Sided|95.0|-5.38|-2.88|||ANCOVA||||
1753251|NCT00291642|3222532|Superiority or Other||Mean Difference (Final Values)|-3.25|Standard Error of the Mean|0.637|<|0.001|2-Sided|95.0|-4.5|-2.0|||ANCOVA||||
1753252|NCT00291642|3222532|Superiority or Other||Mean Difference (Final Values)|-3.35|Standard Error of the Mean|0.64|<|0.001|2-Sided|95.0|-4.61|-2.09|||ANCOVA||||
1753253|NCT00291577|3222534|Superiority or Other||Ratio of adjusted geometric means|95.79||||||90.0|79.82|114.96|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1|
1753254|NCT00291577|3222535|Superiority or Other||Ratio of adjusted geometric means|112.39||||||90.0|81.05|155.85|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1|
1753255|NCT00291577|3222536|Superiority or Other||Ratio of adjusted geometric means|95.57||||||90.0|79.9|114.32|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1|
1753256|NCT00291577|3222538|Superiority or Other||rate (percent)|89.5||||||95.0|66.9|98.7|||||Two-sided CI (%) from exact method based on F distribution.|Clinical Benefit Rate (CR + PR + SD > = 24 weeks)|
1753257|NCT00291577|3222539|Superiority or Other||rate (percent)|73.7||||||95.0|48.8|90.9|||||Two-sided Confidence Interval (CI) (%) from exact method based on F distribution.|Overall confirmed objective response rate (CR + PR)|
1753258|NCT00291577|3222541|Superiority or Other||Ratio of adjusted geometric means|94.98||||||90.0|78.73|114.58|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1|
1753259|NCT00291577|3222542|Superiority or Other||Ratio of adjusted geometric means|99.18||||||90.0|78.73|124.95|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|C1D1 vs C2D1|
1753260|NCT00291577|3222546|Superiority or Other||Ratio of adjusted geometric means|100.0||||||90.0|82.95|120.56|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|Total drug C1D2 vs C2D3|
1753261|NCT00291577|3222546|Superiority or Other||Ratio of adjusted geometric means|81.72||||||90.0|62.4|107.04|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU012662 C1D2 vs C2D3|
1753262|NCT00291577|3222546|Superiority or Other||Ratio of adjusted geometric means|101.23||||||90.0|82.75|123.83|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU011248 C1D2 vs C2D3|
1753263|NCT00291577|3222547|Superiority or Other||Ratio of adjusted geometric means|97.81||||||90.0|80.44|118.94|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|Total drug C1D2 vs C2D3|
1753264|NCT00291577|3222547|Superiority or Other||Ratio of adjusted geometric means|81.96||||||90.0|59.76|112.41|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU012662 C1D2 vs C2D3|
1753265|NCT00291577|3222547|Superiority or Other||Ratio of adjusted geometric means|98.89||||||90.0|80.34|121.73|||||Ratio percent (%) (Test/Reference) of adjusted geometric means; values have been back-transformed from the log scale.|SU011248 C1D2 vs C2D3. Due to the exploratory nature of the study, no statistical hypothesis testing was done since the primary purpose was to assess the tolerability of the combination of SU011248 with docetaxel.|
1753327|NCT00289991|3222731|Superiority or Other||difference in proportions: percent|-0.4||||0.7114|2-Sided|95.0|-2.2|1.5|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95 percent (%) confidence interval for the difference in proportions.|Day 100; difference in proportions (expressed as percentages), voriconazole relative to itraconazole.|
1753266|NCT00291330|3222575|Superiority or Other||Hazard Ratio (HR)|0.71||||0.0002|2-Sided|95.0|0.59|0.85|||Regression, Cox|||Hazard ratio vs. Warfarin for the category of any bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1753267|NCT00291330|3222575|Superiority or Other||Hazard Ratio (HR)|0.82||||0.5063||95.0|0.45|1.48|||Regression, Cox|||Hazard ratio vs. Warfarin for the category major bleeding events (events occurring between 1st intake of study drug and last intake of study drug + 6 days). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1753268|NCT00291330|3222576|Superiority or Other||Hazard Ratio (HR)|0.94||||0.8203||95.0|0.54|1.63|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1753269|NCT00291330|3222576|Superiority or Other||Risk Difference (Percentage)|-0.1||||0.8018||95.0|-1.0|0.8|||Kaplan Meier weighted estimates|||Risk difference at 6 months vs. Warfarin for Proportion of patients who died from any cause. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.|
1753270|NCT00291330|3222577|Superiority or Other||Hazard Ratio (HR)|0.33||||0.3332||95.0|0.03|3.15|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1753271|NCT00291330|3222577|Superiority or Other||Risk Difference (Percentage)|-0.3||||0.5327||95.0|-1.2|0.6|||Kaplan Meier weighted estimates|||Risk difference at 6 months vs. Warfarin for Proportion of patients who died due to VTE . Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.|
1753272|NCT00291330|3222578|Superiority or Other||Hazard Ratio (HR)|2.0||||0.1092||95.0|0.86|4.68|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1753273|NCT00291330|3222578|Superiority or Other||Risk Difference (Percentage)|0.3||||0.2981||95.0|-0.3|1.0|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with symptomatic non-fatal PE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.|
1753274|NCT00291330|3222579|Superiority or Other||Hazard Ratio (HR)|0.76||||0.385||95.0|0.4|1.42|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1753275|NCT00291330|3222579|Superiority or Other||Risk Difference (Percentage)|-0.2||||0.6466||95.0|-1.1|0.7|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with symptomatic DVT at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.|
1753276|NCT00291330|3222580|Superiority or Other||Hazard Ratio (HR)|1.0||||0.9844||95.0|0.69|1.46|||Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1753277|NCT00291330|3222580|Superiority or Other||Risk Difference (Percentage)|0.3||||0.622||95.0|-1.0|1.7|||Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with VTE or death at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.|
1753278|NCT00291330|3222581|Superiority or Other||Hazard Ratio (HR)|1.1||||||95.0|0.65|1.84||||||Hazard ratio vs. Warfarin (events occurring between randomisation and the day 180). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1753300|NCT00290342|3222691|Non-Inferiority or Equivalence|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to tetanus, standardized asymptotic 95% CI for the groups’difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-1.85|1.79||||||Non-inferiority in terms of vaccine response to tetanus|
1754305|NCT00281658|3223910|Superiority or Other (legacy)||Hazard Ratio (HR)|0.52|||||2-Sided|95.0|0.42|0.64|||||||
1753279|NCT00291330|3222581|Non-Inferiority or Equivalence|Non inferiority margin was set up to 3.6% for the risk difference based on KM estimates|Risk Difference (Percentage)|0.4|||<|0.0001||95.0|-0.8|1.5||Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.|Kaplan Meier weighted estimates|||Risk difference vs. Warfarin for Proportion of patients with VTE or death related to VTE at 6 months. Point estimate and 95% CI for the overall risk difference obtained based on the Kaplan Meier (KM) estimates at 6 months (180 days) after adjusting for the stratification factors active cancer at baseline and symptomatic PE at baseline.|
1753280|NCT00291330|3222581|Non-Inferiority or Equivalence|Non inferiority margin was set up to 2.75 for the HR analysis|Hazard Ratio (HR)|1.05|||<|0.0001||95.0|0.65|1.7||Non-inferiority P-Value. Two Statistical analyses performed on primary endpoint. Both non inferiority for the risk difference and for the hazard ratio analyses to be reached in order to conclude positively on the primary endpoint.|Regression, Cox|Patients without events are censored at the end of post treatment period (day 224)||Hazard ratio vs. Warfarin (events occurring between randomisation and end of post treatment period). The time to first occurrence of the primary endpoint was compared between treatment groups using the Cox proportional hazards (PH) model, including the factors treatment, active cancer at baseline, symptomatic PE at baseline, and the interaction between active cancer and symptomatic PE.|
1753281|NCT00291187|3222586|Superiority or Other||Mean Difference (Final Values)|-12.3||||0.002|2-Sided|95.0|-20.0|-4.6|||ANCOVA||||
1753282|NCT00291187|3222586|Superiority or Other||Mean Difference (Final Values)|-14.3|||<|0.001|2-Sided|95.0|-22.1|-6.5|||ANCOVA||||
1753283|NCT00291187|3222586|Superiority or Other||Mean Difference (Final Values)|-11.1|||<|0.006|2-Sided|95.0|-18.9|-3.3|||ANCOVA||||
1753284|NCT00291187|3222587|Superiority or Other||Mean Difference (Final Values)|29.6||||0.005|2-Sided|95.0|9.1|50.0|||ANCOVA||||
1753285|NCT00291187|3222587|Superiority or Other||Mean Difference (Final Values)|47.9|||<|0.001|2-Sided|95.0|27.2|68.6|||ANCOVA||||
1753286|NCT00291187|3222587|Superiority or Other||Mean Difference (Final Values)|33.7|||<|0.002|2-Sided|95.0|13.0|54.5|||ANCOVA||||
1753287|NCT00291187|3222588|Superiority or Other||Mean Difference (Final Values)|-17.4||||0.081|2-Sided|95.0|-37.0|2.1|||ANCOVA||||
1753288|NCT00291187|3222588|Superiority or Other||Mean Difference (Final Values)|-33.7||||0.001|2-Sided|95.0|-53.6|-13.9|||ANCOVA||||
1753289|NCT00291187|3222588|Superiority or Other||Mean Difference (Final Values)|-24.2||||0.017|2-Sided|95.0|-44.1|-4.3|||ANCOVA||||
1753290|NCT00291187|3222589|Superiority or Other||Mean Difference (Final Values)|-22.8|||<|0.001|2-Sided|95.0|-34.2|-11.3|||ANCOVA||||
1753291|NCT00291187|3222589|Superiority or Other||Mean Difference (Final Values)|-26.3|||<|0.001|2-Sided|95.0|-37.8|-14.7|||ANCOVA||||
1753292|NCT00291187|3222589|Superiority or Other||Mean Difference (Final Values)|-21.5|||<|0.001|2-Sided|95.0|-33.1|-9.9|||ANCOVA||||
1753293|NCT00290355|3222679|Other||Hazard Ratio (HR)|0.74||||0.256|2-Sided|95.0|0.44|1.24||Two-sided p value from Cox regression model adjusted for covariate(s) node/squam/stage to test the null hypothesis was: the distribution of time to recurrences was the same in each group (H0 = [HR=1]).|Regression, Cox|The p value by log rank test was 0.1995. Criterion for evaluation of the objective: one sided p-value < 10%||Hazard ratio of GSK 249553 study product.|
1753294|NCT00290342|3222689|Non-Inferiority or Equivalence|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertactin, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.47|||||2-Sided|95.0|-1.4|2.64||||||Immune response non-inferiority - Anti-PRN|
1753295|NCT00290342|3222689|Non-Inferiority or Equivalence|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to filamentous haemagglutinin, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.45|||||2-Sided|95.0|-1.88|2.95||||||Immune response non-inferiority - Anti-FHA|
1753296|NCT00290342|3222689|Non-Inferiority or Equivalence|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to pertussis toxoid, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|1.44|||||2-Sided|95.0|-0.46|4.13||||||Immune response non-inferiority - Anti-PT|
1753297|NCT00290342|3222690|Non-Inferiority or Equivalence|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 3, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|-0.01|||||2-Sided|95.0|-2.28|2.24||||||Immune response non-inferiority - Anti-Polio 3|
1753298|NCT00290342|3222690|Non-Inferiority or Equivalence|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 2, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.49|||||2-Sided|95.0|-1.36|2.71||||||Immune response non-inferiority - Anti-Polio 2|
1753299|NCT00290342|3222690|Non-Inferiority or Equivalence|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to poliovirus type 1, standardized asymptotic 95% CI for the groups’ difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-1.85|1.82||||||Immune response non-inferiority - Anti-Polio 1|
1753453|NCT00289198|3222963|Superiority or Other||Mean Difference (Final Values)|-0.113||||0.076|2-Sided|95.0|-0.24|-0.01|||ANCOVA|||Eye redness score, Placebo vs fluticasone furoate|
1755490|NCT00265616|3225328|Superiority or Other|||||||0.67|||||||Fisher Exact||||
1753301|NCT00290342|3222691|Non-Inferiority or Equivalence|To assess the non-inferiority of the Infanrix-IPV Group compared to the Infanrix + IMOVAX Polio Group in terms of vaccine response to diphtheria, standardized asymptotic 95% CI for the groups’difference (Infanrix-IPV Group minus Infanrix + IMOVAX Polio Group) was computed. Objective of non-inferiority was met since the LL of the 95% CI was above -10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-1.85|1.79||||||Non-inferiority in terms of vaccine response to diphteria|
1753302|NCT00290290|3222698|Superiority or Other||Relative Risk|0.59||||0.004|2-Sided|95.0|0.41|0.85|||Log Rank|||The average baseline rate of surgical-site infection at the six participating hospitals was 14% after clean-contaminated surgery with povidone-iodine skin preparation, and we estimated that substituting chlorhexidine-alcohol for povidone-iodine would reduce this rate to 7%. Therefore, we planned to enroll approximately 430 patients in each study group who could be evaluated in order for the study to have 90% power to detect a significant difference in the rates of surgical-site infection.|
1753303|NCT00290251|3222699|Superiority or Other||||||<|0.05||||||The Delta of scores from treatment end to baseline was used to compare by ANOVA.|ANOVA|Adjustment for age||No sample size calculation was made.|
1753304|NCT00290251|3222700|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|Performed on log-transformed delta change||Ulipristal acetate groups one and two were first compared and found to be similar, so they were combined into a single treatment group for comparison to placebo group|
1753305|NCT00290186|3222707|Superiority or Other||Mean Difference (Final Values)|-38.0||||0.468|2-Sided|95.0|-153.0|77.0|||t-test, 2 sided|||Between-group difference: negative values represent greater improvement in HBO group.|
1753306|NCT00290186|3222708|Superiority or Other||Mean Difference (Final Values)|-79.0||||0.167|2-Sided|95.0|-198.0|41.0|||t-test, 2 sided|||Between-group difference: negative values represent greater improvement in HBO group.|
1753307|NCT00290186|3222709|Superiority or Other||Mean Difference (Final Values)|-1.0||||0.876|2-Sided|95.0|-15.0|13.0|||t-test, 2 sided|||Between-group difference: positive values represent greater improvement in HBO group.|
1753308|NCT00290186|3222710|Superiority or Other||Mean Difference (Final Values)|46.0||||0.157|2-Sided|95.0|-22.0|114.0|||t-test, 2 sided|||Between-group difference: positive values represent greater improvement in HBO group.|
1753309|NCT00290186|3222711|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.473|2-Sided|95.0|-4.7|1.4|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.|
1753310|NCT00290186|3222712|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.648|2-Sided|95.0|-4.0|2.8|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.|
1753311|NCT00290186|3222713|Superiority or Other||Mean Difference (Final Values)|2.3||||0.051|2-Sided|95.0|-0.2|4.7|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.|
1753312|NCT00290186|3222714|Superiority or Other||Mean Difference (Final Values)|0.1||||0.932|2-Sided|95.0|-2.1|2.4|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.|
1753313|NCT00290186|3222715|Superiority or Other||Mean Difference (Final Values)|0.1||||0.945|2-Sided|95.0|-2.3|2.2|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.|
1753314|NCT00290186|3222716|Superiority or Other||Mean Difference (Final Values)|1.1||||0.498|2-Sided|95.0|-1.5|3.7|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.|
1753315|NCT00290186|3222717|Superiority or Other||Mean Difference (Final Values)|0.3||||0.584|2-Sided|95.0|-2.4|3.0|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.|
1753316|NCT00290186|3222718|Superiority or Other||Mean Difference (Final Values)|1.0||||0.685|2-Sided|95.0|-3.0|5.1|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.|
1753317|NCT00290186|3222719|Superiority or Other||Mean Difference (Final Values)|3.5||||0.149|2-Sided|95.0|-1.6|8.6|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.|
1753318|NCT00290186|3222720|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.342|2-Sided|95.0|-5.1|2.2|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.|
1753319|NCT00290186|3222721|Superiority or Other||Mean Difference (Final Values)|1.1||||0.945|2-Sided|95.0|-3.0|5.1|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.|
1753320|NCT00290186|3222722|Superiority or Other||Mean Difference (Final Values)|0.1||||0.921|2-Sided|95.0|-1.6|1.8|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.|
1753321|NCT00290186|3222723|Superiority or Other||Mean Difference (Final Values)|0.9||||0.539||95.0|-1.5|3.3|||ANCOVA|||Between-group difference: positive values represent greater improvement in HBO group.|
1753322|NCT00289991|3222726|Superiority or Other||difference in proportions: percent|-8.8||||0.057|2-Sided|95.0|-17.8|0.3|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95% confidence interval for the difference in proportions.|Difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.|
1753323|NCT00289991|3222728|Superiority or Other||difference in proportions: percent|-4.8||||0.2487|2-Sided|95.0|-13.0|3.4|||Difference in proportions|Difference in proportions (approximate result)|Approximate 2-sided 95 percent % confidence interval for the difference in proportions.|Day 365; difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.|
1753324|NCT00289991|3222729|Superiority or Other|||||||0.0026|||||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon (Mann-Whitney)||Mann-Whitney test used to investigate the null hypothesis that the times to discontinuation of study medication in each treatment group come from the same distribution.|
1753325|NCT00289991|3222730|Superiority or Other||difference in proportions: percent|0.3|||||2-Sided|95.0|-6.3|6.9|||||Approximate 2-sided 95% confidence interval for the difference in proportions.|Day 180; difference in proportions (expressed as a percentage), voriconazole relative to itraconazole.|
1753326|NCT00289991|3222731|Superiority or Other||difference in proportion: percent|-0.3||||0.7759|2-Sided|95.0|-2.5|1.9|||Difference in proportions|Difference in proportions (approximate result).|Approximate 2-sided 95 percent (%) confidence interval for the difference in proportions.|Day 180; difference in proportions (expressed as percentages), voriconazole relative to itraconazole.|
1753328|NCT00289991|3222733|Non-Inferiority or Equivalence|"Non-inferiority inferred if lower limit of the 2-sided 95% confidence interval (CI) for the difference between the voriconazole and itraconazole treatment groups in the adjusted proportion of subjects classified as Success at Day 100 after transplant is above -10%. Superiority achieved if 2-sided 95% CI for difference between these treatment groups in the adjusted proportion of subjects classified as Success at Day 100 after transplant does not include zero and is positive."|percent difference adjusted proportions|15.4|||||2-Sided|95.0|6.6|24.2|||||Overall treatment difference in adjusted proportions (expressed as percentages) calculated using Fleiss method.||
1753329|NCT00289991|3222734|Non-Inferiority or Equivalence|Assuming a true success rate of 50% in voriconazole (Vori) treatment (Tx) group and 45% in itraconazole (Itra) Tx group, sample size of 232 subjects per group=90% power to demonstrate non-inferiority of Vori to Itra using pre-specified non-inferiority margin of -10%. Sample has at least 80% power to demonstrate superiority of Vori over Itra if true success rates for Vori and Itra are 57% and 44% respectively. Based on this, up to 500 subjects were to be enrolled to obtain 464 eligible subjects.|percent difference adjusted proportions|16.4|||||2-Sided|95.0|7.7|25.1|||||Overall treatment difference in adjusted proportions (expressed as percentages) calculated using Fleiss method.|"Non-inferiority inferred if lower limit of the 2-sided 95 percent (%) confidence interval (CI) for the difference between the voriconazole and itraconazole treatment groups in the adjusted proportion of subjects classified as Success at Day 180 after transplant is above -10%. Superiority achieved if 2-sided 95% CI for difference between these treatment groups in the adjusted proportion of subjects classified as Success at Day 180 after transplant does not include zero and is positive."|
1753330|NCT00289900|3222742|Superiority or Other||Difference in Percentage|-0.1||||0.4997|2-Sided|95.0|-0.4|0.5|||Miettinen and Nurminen||||
1753331|NCT00289900|3222743|Superiority or Other||Difference in Percentage|-0.1|||||2-Sided|95.0|-0.8|0.9|||||||
1753332|NCT00289900|3222744|Superiority or Other||Difference in Percentage|11.7|||||2-Sided|95.0|8.9|14.7|||||||
1753333|NCT00289900|3222745|Superiority or Other||Difference in Percentage|-0.7|||||2-Sided|95.0|-2.6|1.4|||||||
1753334|NCT00289900|3222746|Superiority or Other||Difference in Percentage|13.7|||||2-Sided|95.0|9.4|18.0|||||||
1753335|NCT00289900|3222747|Superiority or Other||Difference in Percentage|-0.1||||0.7858|2-Sided|95.0|-0.4|0.6|||Miettinen and Nurminen||||
1753336|NCT00289900|3222748|Superiority or Other||Difference in Percentage|0.7||||0.0233|2-Sided|95.0|0.1|1.7|||Miettinen and Nurminen||||
1753337|NCT00289900|3222749|Superiority or Other||Difference in Percentage|0.1||||0.5625|2-Sided|95.0|-0.3|0.9|||Miettinen and Nurminen||||
1753338|NCT00289900|3222750|Superiority or Other||Difference in Proportion|0.1||||0.134||95.0|-0.1|0.8|||Miettinen and Nurminen||||
1753339|NCT00289900|3222751|Superiority or Other||Difference in Proportion|0.1||||0.134|2-Sided|95.0|-0.1|0.8|||Miettinen and Nurminen||||
1753340|NCT00289900|3222752|Superiority or Other||Difference in Proportion|0.1||||0.556|2-Sided|95.0|-0.2|0.7|||Miettinen and Nurminen||||
1753341|NCT00289900|3222753|Superiority or Other||Difference in Proportion|-0.1||||0.346|2-Sided|95.0|-0.5|0.4|||Miettinen and Nurminen||||
1753342|NCT00289900|3222754|Superiority or Other||Difference in Proportion|-0.7||||0.042|2-Sided|95.0|-1.4|0.0|||Miettinen and Nurminen||||
1753343|NCT00289900|3222755|Superiority or Other||Difference in Proportion|-1.4||||0.008|2-Sided|95.0|-2.3|-0.5|||Miettinen and Nurminen||||
1753344|NCT00289900|3222756|Superiority or Other||Difference in Least Squares Mean|-5.6|||<|0.001|2-Sided|95.0|-8.0|-3.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753345|NCT00289900|3222756|Superiority or Other||Difference in Least Squares Mean|-6.4|||<|0.001|2-Sided|95.0|-8.8|-4.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753346|NCT00289900|3222756|Superiority or Other||Difference in Least Squares Mean|-10.8|||<|0.001|2-Sided|95.0|-13.2|-8.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753347|NCT00289900|3222756|Superiority or Other||Difference in Least Squares Mean|-12.8|||<|0.001|2-Sided|95.0|-15.6|-9.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753348|NCT00289900|3222757|Superiority or Other||Median Difference (Final Values)|16.4|||<|0.001|2-Sided|95.0|9.8|22.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test||
1753349|NCT00289900|3222757|Superiority or Other||Median Difference (Final Values)|11.9|||<|0.005|2-Sided|95.0|5.2|18.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test||
1753350|NCT00289900|3222757|Superiority or Other||Median Difference (Final Values)|6.9|||<|0.083|2-Sided|95.0|0.0|13.8|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test||
1753351|NCT00289900|3222757|Superiority or Other||Median Difference (Final Values)|-0.8|||<|0.5|2-Sided|95.0|-9.6|7.5|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test||
1753352|NCT00289900|3222758|Superiority or Other||Median Difference (Final Values)|-24.6|||<|0.001|2-Sided|95.0|-28.6|-20.0|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test||
1753353|NCT00289900|3222758|Superiority or Other||Median Difference (Final Values)|-23.9|||<|0.001|2-Sided|95.0|-27.8|-19.4|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test||
1753354|NCT00289900|3222758|Superiority or Other||Median Difference (Final Values)|-20.5|||<|0.001|2-Sided|95.0|-25.0|-16.6|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test||
1753355|NCT00289900|3222758|Superiority or Other||Median Difference (Final Values)|-18.8|||<|0.001|2-Sided|95.0|-24.2|-14.2|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test||
1753356|NCT00289900|3222759|Superiority or Other||Difference in Least Squares Mean|6.1|||<|0.001|2-Sided|95.0|4.1|8.1|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753357|NCT00289900|3222759|Superiority or Other||Difference in Least Squares Mean|4.2|||<|0.001|2-Sided|95.0|2.2|6.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753358|NCT00289900|3222759|Superiority or Other||Difference in Least Squares Mean|-0.5|||<|0.595|2-Sided|95.0|-2.5|1.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753359|NCT00289900|3222759|Superiority or Other||Difference in Least Squares Mean|-3.6|||<|0.003|2-Sided|95.0|-6.0|-1.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753360|NCT00289900|3222760|Superiority or Other||Difference in Least Squares Mean|10.7|||<|0.001|2-Sided|95.0|8.7|12.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753361|NCT00289900|3222760|Superiority or Other||Difference in Least Squares Mean|9.0|||<|0.001|2-Sided|95.0|7.0|10.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753362|NCT00289900|3222760|Superiority or Other||Difference in Least Squares Mean|7.7|||<|0.001|2-Sided|95.0|5.8|9.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753363|NCT00289900|3222760|Superiority or Other||Difference in Least Squares Mean|9.0|||<|0.001|2-Sided|95.0|6.6|11.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753364|NCT00289900|3222761|Superiority or Other||Difference in Least Squares Mean|0.2||||0.845|2-Sided|95.0|-2.2|2.7|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753365|NCT00289900|3222761|Superiority or Other||Difference in Least Squares Mean|-0.9||||0.476|2-Sided|95.0|-3.3|1.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753366|NCT00289900|3222761|Superiority or Other||Difference in Least Squares Mean|-5.2|||<|0.001|2-Sided|95.0|-7.7|-2.8|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753367|NCT00289900|3222761|Superiority or Other||Difference in Least Squares Mean|-9.2|||<|0.001|2-Sided|95.0|-12.1|-6.3|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753368|NCT00289900|3222762|Superiority or Other||Difference in Least Sqaures Mean|4.7|||<|0.001|2-Sided|95.0|2.0|7.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753369|NCT00289900|3222762|Superiority or Other||Difference in Least Squares Mean|2.8|||<|0.047|2-Sided|95.0|0.0|5.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753370|NCT00289900|3222762|Superiority or Other||Difference in Least Squares Mean|-3.0|||<|0.037|2-Sided|95.0|-5.8|-0.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753371|NCT00289900|3222762|Superiority or Other||Difference in least Squares Mean|-6.8|||<|0.001|2-Sided|95.0|-10.2|-3.5|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753372|NCT00289900|3222763|Superiority or Other||Difference in Least Squares Mean|2.4||||0.065|2-Sided|95.0|-0.2|5.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753373|NCT00289900|3222763|Superiority or Other||Difference in Least Squares Mean|0.4||||0.771|2-Sided|95.0|-2.2|2.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753374|NCT00289900|3222763|Superiority or Other||Difference in Least Squares Mean|-5.4|||<|0.001|2-Sided|95.0|-8.0|-2.9|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753375|NCT00289900|3222763|Superiority or Other||Difference in Least Squares Mean|-9.1|||<|0.001|2-Sided|95.0|-12.1|-6.0|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753454|NCT00289198|3222963|Superiority or Other||Mean Difference (Final Values)|-0.161||||0.016||95.0|-0.29|-0.03|||ANCOVA|||Eye tearing or watering, Placebo vs fluticasone furoate|
1753376|NCT00289900|3222764|Superiority or Other||Median Difference (Final Values)|-6.8|||<|0.001|2-Sided|95.0|-10.2|-3.4|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test||
1753377|NCT00289900|3222764|Superiority or Other||Median Difference (Final Values)|-10.3|||<|0.001|2-Sided|95.0|-13.7|-7.0|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test||
1753378|NCT00289900|3222764|Superiority or Other||Median Difference (Final Values)|-15.5|||<|0.001|2-Sided|95.0|-19.1|-11.9|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free CI based on Wilcoxon’s rank sum test||
1753379|NCT00289900|3222764|Superiority or Other||Median Difference (Final Values)|-17.3|||<|0.001|2-Sided|95.0|-21.2|-13.3|||Non-parametric ANOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|Hodges-Lehmann estimate of the difference between treatments with a corresponding distribution-free confidence interval (CI) based on Wilcoxon’s rank sum test||
1753380|NCT00289900|3222765|Superiority or Other||Difference in Least Squares Mean|23.0|||<|0.001|2-Sided|95.0|20.7|25.3|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753381|NCT00289900|3222765|Superiority or Other||Difference in Least Squares Mean|22.1|||<|0.001|2-Sided|95.0|19.8|24.4|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753382|NCT00289900|3222765|Superiority or Other||Difference in Least Squares Mean|21.3|||<|0.001|2-Sided|95.0|19.0|23.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753383|NCT00289900|3222765|Superiority or Other||Difference in Least Squares Mean|19.9|||<|0.001|2-Sided|95.0|17.2|22.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753384|NCT00289900|3222766|Superiority or Other||Difference in Least Squares Mean|-4.2||||0.007|2-Sided|95.0|-7.2|-1.2|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753385|NCT00289900|3222766|Superiority or Other||Difference in Least Squares Mean|-5.1|||<|0.001|2-Sided|95.0|-8.1|-2.1|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753386|NCT00289900|3222766|Superiority or Other||Difference in Least Squares Mean|-10.8|||<|0.001|2-Sided|95.0|-13.8|-7.8|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753387|NCT00289900|3222766|Superiority or Other||Difference in Least Squares Mean|-13.2|||<|0.001|2-Sided|95.0|-16.8|-9.6|||ANCOVA|Model with factors for baseline LDL-C and triglyceride stratum, gender, cohort of participants, treatment group and baseline parameter covariate|||
1753388|NCT00289848|3222775|Superiority or Other||Mean Difference (Net)|-56.6|Standard Deviation|59.2|<|0.001||95.0|-68.8|-44.3|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline 2-hr PMG as a covariate|||
1753389|NCT00289848|3222776|Superiority or Other||Mean Difference (Net)|-31.0|Standard Deviation|39.8|<|0.001||95.0|-38.4|-23.7|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline FPG as a covariate|||
1753390|NCT00289848|3222777|Superiority or Other||Mean Difference (Net)|-1.03|Standard Deviation|1.08|<|0.001||95.0|-1.23|-0.83|||ANCOVA|ANCOVA with terms of treatment, country, prior diabetes pharmacotherapy (not on AHA or on AHA), and baseline A1C as a covariate|||
1753391|NCT00289783|3222837|Non-Inferiority|Criterion for non-inferiority (42 days after the fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroconversion ≥ 1:5 dilution, in initially seronegative subjects (< 1:5), for anti-varicella antibody is ≥ -10% (clinical limit for non-inferiority).|Difference in percentage|-0.14|||||2-Sided|95.0|-0.78|1.56||||||To demonstrate the non-inferiority of Varivax vaccine co-administered with a fourth dose of Menhibrix vaccine compared to Varivax vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with M-M-R II vaccine in terms of immunogenicity to varicella as measured by fluorescent antibody to membrane antigen (FAMA).|
1753392|NCT00289783|3222838|Non-Inferiority|Criterion for non-inferiority (42 days after fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroresponse ≥10 IU/ml, in initially seronegative subjects (< 4 IU/ml), for anti-rubella antibody is ≥ -5% (clinical limit for non-inferiority).|Difference in percentage|0.12|||||2-Sided|95.0|-0.57|1.73||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.|
1753393|NCT00289783|3222839|Non-Inferiority|Criterion for non-inferiority (42 days after fourth dose vaccination): Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with a seroconversion ≥28 ED50, in subjects with initial anti-mumps antibody < 28 ED50, for anti-mumps antibody is ≥ -5% (clinical limit for non-inferiority).|Difference in percentage|-1.0|||||2-Sided|95.0|-2.16|0.98||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M--M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.|
1753455|NCT00289198|3222963|Superiority or Other||Mean Difference (Final Values)|-0.215||||0.002|2-Sided|95.0|-0.35|-0.08|||ANCOVA|||Eye itching/burning score, Placebo vs fluticasone furoate|
1753394|NCT00289783|3222840|Non-Inferiority|Criteria for non-inferiority (42 days after the fourth dose): Lower limit of the two-sided standardized asymptotic 95% CI on the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with anti-PRP concentration ≥ 1.0 µg/mL is ≥ -10% (clinical limit for non-inferiority)|Difference in percentage|-0.04|||||2-Sided|95.0|-1.78|3.57||||||To demonstrate that, following a fourth dose, the immune response to Hib polysaccharide (PRP) in the group that received 3 primary vaccine doses of Menhibrix vaccine and a fourth dose of Menhibrix vaccine coadministered with M-M-R II and Varivax vaccines was non-inferior to the corresponding immune response in the group that received 3 primary vaccine doses of ActHIB vaccine and a fourth dose of PedvaxHIB vaccine co-administered with M-M-R II and Varivax vaccines.|
1753395|NCT00289783|3222841|Non-Inferiority|Lower limit of the standardized asymptotic 95% CI for the difference (Menhibrix vaccine fourth dose group minus ActHIB fourth dose group) in the percentage of subjects with seroconversion ≥ 150 mIU/mL, in initially seronegative subjects (<150 mIU/mL), for anti-measles antibody is ≥-5% (clinical limit for non-inferiority).|Difference in percentage|-0.15|||||2-Sided|95.0|-2.56|3.06||||||To demonstrate the non-inferiority of M-M-R II vaccine when co-administered with a fourth dose of Menhibrix vaccine compared to M-M-R II vaccine co-administered with a fourth dose of PedvaxHIB vaccine, each co-administered with Varivax vaccine.|
1753396|NCT00289783|3222845|Non-Inferiority|Point estimate = Lower limit (LL) = Upper limit (UL) as LL and UL values were not available due to the departure from lognormal distribution (large number of imputed values).|GMT ratio|21.1|||||2-Sided|95.0|21.1|21.1||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.|
1753397|NCT00289783|3222845|Non-Inferiority|Criteria for immunogenicity of MenY (42 days after the fourth dose): Lower limit of the asymptotic 95% CI for the geometric mean of individual ratio of post-dose 4/pre-dose 4 is ≥ 2.|GMT ratio|11.8|||||2-Sided|95.0|10.2|13.8||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenY.|
1753398|NCT00289783|3222846|Non-Inferiority|Point estimate = Lower limit (LL) = Upper limit (UL) as LL and UL values were not available due to the departure from lognormal distribution (large number of imputed values)|GMT ratio|1.4|||||2-Sided|95.0|1.4|1.4||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.|
1753399|NCT00289783|3222846|Non-Inferiority|Criteria for immunogenicity of MenC (42 days after the fourth dose): Lower limit of the asymptotic 95% CI for the geometric mean of individual ratio of post-dose 4/pre-dose 4 is ≥ 2.|GMT ratio|12.0|||||2-Sided|95.0|10.4|13.8||||||To evaluate the specific effect of a fourth dose of Menhibrix vaccine co-administered with M-M-R II and Varivax vaccines at 12 to 15 months of age in terms of a fourth dose vaccine response as measured by hSBA-MenC.|
1753400|NCT00289783|3222847|Equivalence|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the [0.5; 2.0] interval.|GMT ratio|0.87|||||2-Sided|95.0|0.62|1.21||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).|
1753401|NCT00289783|3222847|Equivalence|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the [0.5; 2.0] interval.|GMT ratio|1.4|||||2-Sided|95.0|0.99|1.97||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).|
1753402|NCT00289783|3222847|Equivalence|For each pair of lots and for the immune response to hSBA-MenY, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the [0.5; 2.0] interval.|GMT ratio|1.61|||||2-Sided|95.0|1.14|2.27||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup Y (MenY) as measured by a serum bactericidal assay using human complement (hSBA).|
1753403|NCT00289783|3222848|Equivalence|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the [0.5; 2.0] interval.|GMT ratio|0.79|||||2-Sided|95.0|0.6|1.04||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).|
1753404|NCT00289783|3222848|Equivalence|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the [0.5; 2.0] interval.|GMT ratio|0.97|||||2-Sided|95.0|0.74|1.29||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).|
1753405|NCT00289783|3222848|Equivalence|For each pair of lots and for the immune response to hSBA-MenC, the two-sided 95% confidence interval (CI) on the geometric mean titers (GMTs) ratio between lots is within the [0.5; 2.0] interval.|GMT ratio|1.23|||||2-Sided|95.0|0.93|1.62||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for N. meningitidis serogroup C (MenC) as measured by a serum bactericidal assay using human complement (hSBA).|
1753456|NCT00289198|3222964|Superiority or Other||Mean Difference (Final Values)|-0.156||||0.01|2-Sided|95.0|-0.27|-0.04|||ANCOVA|||Eye redness, Placebo vs fluticasone furoate|
1753457|NCT00289198|3222964|Superiority or Other||Mean Difference (Final Values)|-0.137||||0.028|2-Sided|95.0|-0.26|-0.02|||ANCOVA|||Eye tearing/watering score, Placebo vs fluticasone furoate|
1753458|NCT00289198|3222964|Superiority or Other||Mean Difference (Final Values)|-0.216||||0.001|2-Sided|95.0|-0.34|-0.09|||ANCOVA|||Eye itching/burning score, Placebo vs fluticasone furoate|
1753406|NCT00289783|3222849|Equivalence|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the [0.5; 2.0] interval.|GMC ratio|1.0|||||2-Sided|95.0|0.8|1.26||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.|
1753407|NCT00289783|3222849|Equivalence|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by ELISA the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the [0.5; 2.0] interval.|GMC ratio|1.12|||||2-Sided|95.0|0.89|1.42||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.|
1753408|NCT00289783|3222849|Equivalence|Criteria for lot-to-lot consistency (1 month after primary vaccination): For each pair of lots and for the immune response to anti-PRP measured by Enzyme Linked Immunosorbent Assay (ELISA) the two-sided 95% confidence interval (CI) on the geometric mean concentrations (GMCs) ratio between lots is within the [0.5; 2.0] interval.|GMC ratio|1.12|||||2-Sided|95.0|0.89|1.42||||||To demonstrate the lot-to-lot consistency of 3 manufacturing lots of Hib-MenCY-TT vaccine co-administered with DTPa-HBV-IPV vaccine following 3 primary doses in terms of immunogenicity for polyribosylribitol phosphate (PRP) as measured by ELISA.|
1753409|NCT00289731|3222902|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seroprotection rates for anti-HBs antibody, being - 15%.|Difference in seroprotection rates|20.69|||||2-Sided|95.0|12.92|28.62||||||Difference in seropositivity rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HBs seroprotection rates, at Month 7.|
1753410|NCT00289731|3222902|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seroprotection rates for anti-HBs antibody, being - 10%.|Difference in seroprotection rate|12.04|||||2-Sided|95.0|4.97|19.35||||||Difference in seroprotection rates against hepatitis B surface (HBs) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HBs seroprotection rates, at Month 7.|
1753411|NCT00289731|3222903|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus HB VAX PRO+Vaqta Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%.|Difference in seropositivity rate|-1.63|||||2-Sided|95.0|-5.31|1.6||||||Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines HB VAX PRO at Months 0, 1 and 6 and Vaqta at Months 0 and 6 (HB VAX PRO+Vaqta Group), in terms of anti-HAV seropositivity rates, at Month 7.|
1753412|NCT00289731|3222903|Non-Inferiority|Non-inferiority was defined as the lower limit of the 95% CI for the difference between the two treatment groups (Twinrix Group minus Engerix-B+Havrix Group), in terms of seropositivity rates for anti-HAV antibody, being - 10%.|Difference in seropositivity rate|-1.66|||||2-Sided|95.0|-5.34|1.48||||||Difference in seropositivity rates against hepatitis A virus (HAV) antigen: To demonstrate that the immunogenicity of Twinrix vaccine (Twinrix Group) administered at Months 0, 1 and 6 was non-inferior to that of separately administered monovalent vaccines Engerix-B at Months 0, 1 and 6 and Havrix at Months 0 and 6 (Engerix-B+Havrix Group), in terms of anti-HAV seropositivity rates, at Month 7.|
1753413|NCT00289536|3222918|Superiority or Other||||||<|0.0001||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of terminal half-life to pre-infusion level of VWF:Ag with dose groups combined.|
1753414|NCT00289536|3222918|Superiority or Other||||||<|0.0001||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of AUC/Dose to pre-infusion level of VWF:Ag with dose groups combined.|
1753415|NCT00289536|3222918|Superiority or Other||||||<|0.3696||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of initial recovery to pre-infusion level of VWF:Ag with dose groups combined.|
1753416|NCT00289536|3222919|Superiority or Other|||||||0.0056||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of terminal half-life to pre-infusion level of VWF:Rco with dose groups combined.|
1753417|NCT00289536|3222919|Superiority or Other|||||||0.0322||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: relationship of AUC/Dose to pre-infusion level of VWF:Rco with dose groups combined.|
1753418|NCT00289536|3222919|Superiority or Other|||||||0.7048||||||No adjustments were made for multiple comparisons.|Regression, Linear|||Regression analysis: Relationship of initial recovery to pre-infusion level of VWF:Rco with dose groups combined.|
1753419|NCT00289536|3222927|Superiority or Other|||||||0.5057|||||||ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean terminal half-life will be the same in each dose group.|
1753420|NCT00289536|3222928|Superiority or Other|||||||0.0965||||||No adjustments were made for multiple comparisons.|ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean log AUC/dose will be the same in each dose group.|
1753421|NCT00289536|3222929|Superiority or Other|||||||0.1662|||||||ANOVA|Repeated measures ANOVA with dose as fixed effect||Null Hypothesis: The mean log initial recovery will be the same in each dose group.|
1753422|NCT00289341|3222937|Superiority or Other|||||||0.016|||||||Linear Spline model||||
1753423|NCT00289341|3222939|Superiority or Other||||||>|0.2|||||||Fisher Exact|||for all other adverse events|
1753424|NCT00289341|3222939|Superiority or Other||||||>|0.001|||||||Fisher Exact|||for injection site reaction only|
1753425|NCT00289289|3222944|Superiority or Other||Median Difference (Net)|0.0||||0.394||95.0||||Within each randomized subject, the ON minus OFF difference in AT/AF burden was computed. The Wilcoxon Signed-Rank test was used to determine if the ON minus OFF difference in AT/AF burden was different from zero.|Wilcoxon (Mann-Whitney)||A negative median difference represents an improvement (lessening) of AT/AF burden during periods of ON versus OFF programming. A positive median difference represents an increase in AT/AF burden during ON compared to OFF programming.|Null Hypothesis: There is no difference in AT/AF burden during periods on ON and OFF programming Alternative Hypothesis: AT/AF burden is lower during periods of ON programming compared to periods of OFF programming|
1753426|NCT00289289|3222945|Superiority or Other||Hazard Ratio (HR)|0.82||||0.603|2-Sided|95.0|0.39|1.73||P-value is based on a repeated measures Cox proportional hazards model to the rate of AF cardioversion attempts between periods of ON and OFF programming|Regression, Cox||Hazard Ratio compares rate of first attempted cardioversion for AF while the intervention pacing features were programmed ON versus OFF.|"Null Hypothesis: AF Cardioversion attempt rate is the same during periods of ON and OFF programming~Alternative Hypothesis: AF Cardioversion attempt rate is different during periods of ON and OFF programming"|
1753427|NCT00289289|3222946|Superiority or Other||Median Difference (Final Values)|-1.0||||0.165|||||||Wilcoxon (Mann-Whitney)|P-value is from Koch's adaptation to the Wilcoxon Rank-Sum test comparing the within subject ON minus OFF differences to 0|A negative change means an improvement in AF symptom frequency with intervention pacing therapy programmed ON. Total possible improvement while intervention features are programmed ON is -64. Total possible worsening during ON programming is 64.|"The null hypothesis is that the symptom frequency score does not differ between while intervention pacing features were programmed ON versus OFF.~This secondary objective was not powered."|
1753428|NCT00289289|3222947|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Deviation|4.8||0.629|1-Sided|95.0||0.5||P-value is from a paired t-test since each subject had the intervention pacing features turned ON and OFF in this crossover study|t-test, 1 sided|One-sided paired t-test with 221 degrees of freedom|A mean difference greater than zero indicates an average increase in atrial fibrillation/atrial tachycardia symptomatic episodes while the intervention pacing features were programmed ON versus OFF.|Null Hypothesis: rate of symptomatic atrial tachycardia/atrial fibrillation episodes during periods when intervention pacing features ON is greater to or equal to the rate of symptomatic atrial tachycardia/atrial fibrillation episodes during periods where intervention pacing features were programmed OFF Alternative Hypothesis: rate of symptomatic AT/AF during periods of ON programming is less than the rate of symptomatic AT/AF during OFF programming|
1753429|NCT00289211|3222952|Superiority or Other|||||||0.0017||||||Change at 12 hours post-infusion.|Wilcoxon (Mann-Whitney)||||
1753430|NCT00289211|3222952|Superiority or Other|||||||0.121||||||Change at 4 hours post-infusion.|Wilcoxon (Mann-Whitney)||||
1753431|NCT00289211|3222952|Superiority or Other|||||||0.5218||||||Change at 2 hours post-infusion.|Wilcoxon (Mann-Whitney)||||
1753432|NCT00289211|3222952|Superiority or Other|||||||0.1321||||||Change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)||||
1753433|NCT00289211|3222953|Superiority or Other|||||||0.0022||||||Percent change 12 hours post-infusion.|Wilcoxon (Mann-Whitney)||||
1753434|NCT00289211|3222953|Superiority or Other||||||<|0.0001||||||Percent change 4 hours post-infusion.|Wilcoxon (Mann-Whitney)||||
1753435|NCT00289211|3222953|Superiority or Other||||||<|0.0001||||||Percent change 2 hours post-infusion.|Wilcoxon (Mann-Whitney)||||
1753436|NCT00289211|3222953|Superiority or Other||||||<|0.0001||||||Percent change 1 hour post-infusion.|Wilcoxon (Mann-Whitney)||||
1753437|NCT00289211|3222954|Superiority or Other|||||||0.0007||||||Change at 12 hours post-infusion.|Wilcoxon (Mann-Whitney)||||
1753438|NCT00289211|3222954|Superiority or Other||||||<|0.0001||||||Change at 4 hours post-infusion.|Wilcoxon (Mann-Whitney)||||
1753439|NCT00289211|3222954|Superiority or Other||||||<|0.0001||||||Change at 2 hours post-infusion.|Wilcoxon (Mann-Whitney)||||
1753440|NCT00289211|3222954|Superiority or Other||||||<|0.0001||||||Change at 1 hour post-infusion.|Wilcoxon (Mann-Whitney)||||
1753441|NCT00289211|3222955|Superiority or Other||Hazard Ratio (HR)|2.717||||0.001||95.0|1.471|5.02|||Regression, Cox|||Subjects who had not experienced complete resolution of the HAE attack at the time of the follow-up telephone call, or who were lost to follow-up, were censored at 72 hours.|
1753442|NCT00289211|3222956|Superiority or Other||Risk Ratio (RR)|1.41||||0.062||95.0|0.87|2.29|||Cochran-Mantel-Haenszel||||
1753443|NCT00289211|3222957|Superiority or Other||Hazard Ratio (HR)|2.048||||0.048||95.0|1.008|4.164|||Regression, Cox|||Subjects who did not experience beginning of substantial relief of the defining symptom within 4 hours after initial treatment were included in the analysis as censored observations. Entries of 4.0 (hours) for median time to event or 95% CI indicate that data were NE (see Population Description). As non-numeric data are not supported by the median and 95% CI fields, entry of the actual results (ie, NE or >4.0) was not possible.|
1753444|NCT00289198|3222958|Superiority or Other||Mean Difference (Final Values)|7.638||||0.009|2-Sided|95.0|1.89|13.39|||ANCOVA||||
1753445|NCT00289198|3222959|Superiority or Other||Mean Difference (Final Values)|9.28||||0.002|2-Sided|95.0|3.52|15.04|||ANCOVA||||
1753446|NCT00289198|3222960|Superiority or Other||Mean Difference (Final Values)|8.376||||0.004|2-Sided|95.0|2.71|14.04|||ANCOVA||||
1753447|NCT00289198|3222961|Superiority or Other||Mean Difference (Final Values)|-0.142||||0.022|2-Sided|95.0|-0.26|-0.02|||ANCOVA|||Eye Redness score, Placebo vs fluticasone furoate|
1753448|NCT00289198|3222961|Superiority or Other||Mean Difference (Final Values)|-0.13||||0.04|2-Sided|95.0|-0.25|-0.01|||ANCOVA|||Eye Tearing/Watering score, Placebo vs fluticasone furoate|
1753449|NCT00289198|3222961|Superiority or Other||Mean Difference (Final Values)|-0.223||||0.001|2-Sided|95.0|-0.35|-0.09|||ANCOVA|||Eye itching/burning, Placebo vs fluticasone furoate|
1753450|NCT00289198|3222962|Superiority or Other||Mean Difference (Final Values)|-0.176||||0.005|2-Sided|95.0|-0.3|-0.05|||ANCOVA|||Eye Redness score, Placebo vs Fluticasone furoate|
1753451|NCT00289198|3222962|Superiority or Other||Mean Difference (Final Values)|-0.145||||0.023|2-Sided|95.0|-0.27|-0.02|||ANCOVA|||Eye tearing/watering, Placebo vs Fluticasone furoate|
1753452|NCT00289198|3222962|Superiority or Other||Mean Difference (Final Values)|-0.211||||0.001|2-Sided|95.0|-0.34|-0.08|||ANCOVA|||Eye itching/burning score, Placebo vs Fluticasone furoate|
1753464|NCT00289198|3222969|Superiority or Other||Mean Difference (Final Values)|-0.336|||<|0.001|2-Sided|95.0|-0.48|-0.2|||ANCOVA|||Nasal Itching score, Placebo vs Fluticasone furoate|
1753465|NCT00289198|3222969|Superiority or Other||Mean Difference (Final Values)|-0.264|||<|0.001|2-Sided|95.0|-0.4|-0.12|||ANCOVA|||Nasal Congestion score, Placebo vs Fluticasone furoate|
1753466|NCT00289198|3222969|Superiority or Other||Mean Difference (Final Values)|-0.292|||<|0.001||95.0|-0.43|-0.15|||ANCOVA|||Rhinorrhea score, Placebo vs Fluticasone furoate|
1753467|NCT00289198|3222970|Superiority or Other||Mean Difference (Final Values)|-0.374||||0.001|2-Sided|95.0|-0.5|-0.25|||ANCOVA|||Sneezing score, Placebo versus fluticasone furoate|
1753468|NCT00289198|3222970|Superiority or Other||Mean Difference (Final Values)|-0.324||||0.001|2-Sided|95.0|-0.45|-0.19|||ANCOVA|||Nasal itching score, Placebo versus fluticasone furoate|
1753469|NCT00289198|3222970|Superiority or Other||Mean Difference (Final Values)|-0.314||||0.001|2-Sided|95.0|-0.45|-0.17|||ANCOVA|||Nasal Congestion score, Placebo versus fluticasone furoate|
1753470|NCT00289198|3222970|Superiority or Other||Mean Difference (Final Values)|-0.281||||0.001|2-Sided|95.0|-0.42|-0.14|||ANCOVA|||Rhinorrhea score,Placebo versus fluticasone furoate|
1753471|NCT00289198|3222971|Superiority or Other||Mean Difference (Final Values)|-0.372||||0.001|2-Sided|95.0|-0.5|-0.24|||ANCOVA|||Sneezing score, Placebo versus fluticasone furoate|
1753472|NCT00289198|3222971|Superiority or Other||Mean Difference (Final Values)|-0.372||||0.001|2-Sided|95.0|-0.5|-0.24|||ANCOVA|||Nasal itching score, Placebo versus fluticasone furoate|
1753473|NCT00289198|3222971|Superiority or Other||Mean Difference (Final Values)|-0.37||||0.001|2-Sided|95.0|-0.51|-0.23|||ANCOVA|||Nasal Congestion score, Placebo versus fluticasone furoate|
1753474|NCT00289198|3222971|Superiority or Other||Mean Difference (Final Values)|-0.357||||0.001|2-Sided|95.0|-0.5|-0.22|||ANCOVA|||Rhinorrhea score, Placebo versus fluticasone furoate|
1753475|NCT00289198|3222972|Superiority or Other||Mean Difference (Final Values)|-0.39|||<|0.001|2-Sided|95.0|-0.52|-0.27|||ANCOVA|||Sneezing score, Placebo vs Fluticasone furoate|
1753476|NCT00289198|3222972|Superiority or Other||Mean Difference (Final Values)|-0.331|||<|0.001|2-Sided|95.0|-0.47|-0.2|||ANCOVA|||Nasal Itching, Placebo vs Fluticasone furoate|
1753477|NCT00289198|3222972|Superiority or Other||Mean Difference (Final Values)|-0.277|||<|0.001|2-Sided|95.0|-0.42|-0.14|||ANCOVA|||Nasal Congestion, Placebo vs Fluticasone furoate|
1753478|NCT00289198|3222972|Superiority or Other||Mean Difference (Final Values)|-0.277|||<|0.001|2-Sided|95.0|-0.41|-0.14|||ANCOVA|||Rhinorrhea score, Placebo vs Fluticasone furoate|
1753479|NCT00289198|3222973|Superiority or Other||Mean Difference (Final Values)|-20.033|||<|0.001|2-Sided|95.0|-27.13|-12.94|||ANCOVA||||
1753480|NCT00289198|3222974|Superiority or Other||Mean Difference (Final Values)|-14.118|||<|0.001|2-Sided|95.0|-20.03|-8.21|||ANCOVA||||
1753481|NCT00289198|3222975|Superiority or Other||Mean Difference (Final Values)|-1.291|||<|0.001|2-Sided|95.0|-1.77|-0.81|||ANCOVA||||
1753482|NCT00289198|3222976|Superiority or Other||Mean Difference (Final Values)|-1.274|||<|0.001|2-Sided|95.0|-1.74|-0.81|||ANCOVA||||
1753483|NCT00289198|3222977|Superiority||||||<|0.001|||||||Regression, Logistic|Based on logistic regression adjusting for age, gender and country|||
1753484|NCT00289198|3222978|Superiority or Other||Mean Difference (Final Values)|-1.459|||<|0.001|2-Sided|95.0|-1.93|-0.99||Mean change from Baseline in AM pre-dose instantaneous TNSS over entire period for Placebo versus that for Fluticasone furoate|ANCOVA||||
1753485|NCT00289198|3222979|Superiority or Other||Mean Difference (Final Values)|-1.256|||<|0.001|2-Sided|95.0|-1.73|-0.78||Change from Baseline (Day 1) in reflective total nasal symptom scores for Placebo versus that for fluticasone furoate|ANCOVA||||
1753486|NCT00288912|3223031|Superiority or Other||Mean Difference (Final Values)|0.4||||0.066|2-Sided|95.0|0.0|0.7|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.|
1753487|NCT00288912|3223031|Superiority or Other||Mean Difference (Final Values)|0.4||||0.043|2-Sided|95.0|0.0|0.8|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in arthritis self-efficacy score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.|
1753488|NCT00288912|3223032|Superiority or Other||Mean Difference (Final Values)|0.0||||0.79|2-Sided|95.0|-0.3|0.4|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.|
1753489|NCT00288912|3223032|Superiority or Other||Mean Difference (Final Values)|0.1||||0.78|2-Sided|95.0|-0.3|0.4|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 affect score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.|
1753490|NCT00288912|3223033|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.43|2-Sided|95.0|-0.2|0.2|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.|
1753491|NCT00288912|3223033|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.093|2-Sided|95.0|-0.5|0.0|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Secondary hypothesis: OA self-management intervention results in greater improvement in AIMS2 function score than usual care or health education control. Analyses were linear mixed models, intent-to-treat basis.|
1753492|NCT00288912|3223034|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.105|2-Sided|95.0|-0.8|0.1|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.|
1753493|NCT00288912|3223034|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.007|2-Sided|95.0|-1.0|0.2|||Mixed Models Analysis||The mean difference (final values) is based on differences in the outcome between study groups at 12-month follow-up, in the context of the mixed models.|Primary hypothesis: OA self-management intervention results in greater improvement in AIMS2 pain score than usual care or health education control. Sample size estimate based on detecting 0.57 point (14%) difference between groups. Analyses were linear mixed models, intent-to-treat basis.|
1753494|NCT00288704|3223048|Superiority or Other||||||<|0.0001|||||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.|
1753495|NCT00288704|3223049|Superiority or Other||||||<|0.0001|||||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.|
1753496|NCT00288704|3223050|Superiority or Other||||||<|0.0001|||||||Fisher Exact|||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.|
1753497|NCT00288704|3223051|Superiority or Other||||||<|0.01|||||||ANCOVA|Comparison p-value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||"Please note that the changes are medians (not means).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."|
1753498|NCT00288704|3223052|Superiority or Other||||||<|0.0001|||||||ANCOVA|Comparison p-value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||"Please note that the changes are medians (not means).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."|
1753499|NCT00288704|3223053|Superiority or Other||||||<|0.0001|||||||ANCOVA|Comparison p-value is a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.|
1753500|NCT00288704|3223054|Superiority or Other||||||<|0.0001|||||||ANCOVA|Comparison P-Value was a parametric ANCOVA main effects model with Part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.|
1753501|NCT00288704|3223055|Superiority or Other||||||<|0.0001|||||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.|
1753502|NCT00288704|3223056|Superiority or Other||||||<|0.001|||||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||"Subjects received rilonacept 160 mg for 9 weeks (weeks 6-15), and then were re-randomized 1:1 into either Placebo or rilonacept 160 mg. The endpoint for the period was 9 weeks later (week 24).~The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used."|
1753503|NCT00288704|3223057|Superiority or Other||||||<|0.0001|||||||ANCOVA|Comparison of p-value was a parametric ANCOVA main effects model with part A Baseline variable as covariate and treatment.||The sample size calculations at the time suggested 50 subjects would be enrolled at baseline. The Full Analysis Set (FAS) was used. The FAS included subjects who received at least one dose of rilonacept. Last observation carried forward was used.|
1753504|NCT00288639|3223064|Superiority or Other||Mean Response Ratio|-20.78|Standard Deviation|50.334||||95.0|-35.24|-6.33|||||Seizure freq. >3 / 28 d. Resp. ratio = 100 x [(t – b)/(t + b)] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.|
1753505|NCT00288639|3223064|Superiority or Other||Mean Response Ratio|-24.93|Standard Deviation|60.867||||95.0|-43.66|-6.2|||||Seizure freq. ≤3 / 28 d. Resp. ratio = 100 x [(t – b)/(t + b)] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.|
1753506|NCT00288639|3223068|Superiority or Other||Mean Response Ratio|-23.85|Standard Deviation|84.313||||95.0|-55.33|7.64|||||Evolved to Generalized. Response ratio = 100 x [(t – b)/(t + b)] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.|
1753507|NCT00288639|3223068|Superiority or Other||Mean Response Ratio|-22.24|Standard Deviation|68.058||||95.0|-37.8|-6.69|||||Complex Partial Seizures. Response ratio = 100 x [(t – b)/(t + b)] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.|
1753508|NCT00288639|3223068|Superiority or Other||Mean Response Ratio|7.19|Standard Deviation|84.425||||95.0|-17.6|31.98|||||Simple Partial Seizures. Response ratio = 100 x [(t – b)/(t + b)] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.|
1753509|NCT00288639|3223069|Superiority or Other||Mean Response Ratio|-44.24|Standard Deviation|62.703||||95.0|-58.47|-30.01|||||>140 Days. Response ratio= 100 x [(t – b)/(t + b)] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.|
1753510|NCT00288639|3223069|Superiority or Other||Mean Response Ratio|-38.75|Standard Deviation|59.368||||95.0|-51.79|-25.7|||||113-140 Days. Response ratio=100 x [(t – b)/(t + b)] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.|
1753511|NCT00288639|3223069|Superiority or Other||Mean Response Ratio|-30.75|Standard Deviation|58.11||||95.0|-43.44|-18.06|||||85-112 Days. Response ratio=100 x [(t – b)/(t + b)] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.|
1753512|NCT00288639|3223069|Superiority or Other||Mean Response Ratio|-27.18|Standard Deviation|59.323||||95.0|-39.9|-14.46|||||57-84 Days. Response ratio = 100 x [(t – b)/(t + b)] where t= 4 wk interval seizure frequency and b=baseline seizure frequency. .|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.|
1753513|NCT00288639|3223069|Superiority or Other||Mean Response Ratio|-22.83|Standard Deviation|57.543||||95.0|-34.74|-10.91|||||29-56 Days. Response ratio = 100 x [(t – b)/(t + b)] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power,true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.|
1753514|NCT00288639|3223069|Superiority or Other||Mean Response Ratio|-22.43|Standard Deviation|56.615||||95.0|-34.16|-10.71|||||1-28 Days. Response ratio = 100 x [(t – b)/(t + b)] where t= 4 wk interval seizure frequency and b=baseline seizure frequency.|Noncomparative study.Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts.Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%.Allowing for dropouts assume 85% pts analyzed.|
1753515|NCT00288639|3223070|Superiority or Other||Mean Response Ratio|-17.26|Standard Deviation|48.797||||95.0|-27.36|-7.15|||||Response ratio = 100 x [(t – b)/(t + b)] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.|
1753516|NCT00288639|3223071|Superiority or Other||Mean Response Ratio|-22.72|Standard Deviation|55.232||||95.0|-34.16|-11.28|||||Response ratio = 100 x [(t – b)/(t + b)] where t=treatment seizure frequency and b=baseline seizure frequency.|Noncomparative study. Summary stats, 2 sided 95% CI to est. effect size. No adjustments made to alpha levels to acct for multiple 2o endpts. Sample size=83 patients (pts) sufficient to detect statistically significant difference in % change from baseline in 28-day seizure rate with 80% power, true change from baseline approximately 25%. Allowing for dropouts assume 85% pts analyzed.|
1753517|NCT00288600|3223092|Superiority or Other|||||||0.765|||||||Chi-squared, Corrected|||Need of Exchange transfusion following the AAP criteria|
1753518|NCT00288574|3223098|Superiority|||||||0.26|||||||Mixed Models Analysis|Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.||Random effects regression analysis of change during treatment on the YBC-EDS, in fluoxetine vs placebo groups.|
1753519|NCT00288574|3223099|Superiority|||||||0.25||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment on Perfectionism subscale, in fluoxetine vs placebo groups.|
1753520|NCT00288574|3223100|Superiority|||||||0.86||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment on Body Dissatisfaction subscale, in fluoxetine vs placebo groups.|
1753521|NCT00288574|3223101|Superiority|||||||0.46||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Bulimia subscale, in fluoxetine vs placebo groups.|
1753522|NCT00288574|3223102|Superiority|||||||0.19||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Drive for Thinness subscale, in fluoxetine vs placebo groups.|
1753523|NCT00288574|3223103|Superiority|||||||0.78||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in Q-LES-Q, in fluoxetine vs placebo groups.|
1753524|NCT00288574|3223104|Superiority|||||||0.69||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in RSES, in fluoxetine vs placebo groups.|
1753525|NCT00288574|3223105|Superiority|||||||0.79||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in BDI, in fluoxetine vs placebo groups.|
1753526|NCT00288574|3223106|Superiority|||||||0.007||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment of BDI in fluoxetine versus placebo groups|
1753527|NCT00288574|3223107|Superiority|||||||0.75||||||Reported p values of secondary measures were not corrected for multiple comparisons. The Bonferroni corrected level of significance is <0.005.|Mixed Models Analysis|||Random effects regression analysis of change during treatment in body weight, in fluoxetine vs placebo groups.|
1753528|NCT00288574|3223108|Superiority|||||||0.57|||||||Chi-squared|||The proportion of patients successfully completing the trial in the fluoxetine and placebo groups was compared using the chi-squared statistic.|
1753529|NCT00288080|3223117|Superiority or Other (legacy)|||||||0.0484|||||||Log Rank|||Disease-free survival rates were compared by a two-sided log-rank test at a significance level of 0.05.|
1753530|NCT00288080|3223118|Superiority or Other (legacy)|||||||0.21|||||||Log Rank|||Distant failure rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-side log-rank test at the 0.05 significance level.|
1753531|NCT00288080|3223120|Superiority or Other (legacy)|||||||0.22|||||||Log Rank|||Biochemical control rates at 4 years were calculated using the Kaplan-Meier method and compared by a two-sided log-rank test with a significance level of 0.05.|
1753532|NCT00288080|3223121|Superiority or Other (legacy)|||||||0.0398|||||||Log Rank|||The study was designed to detect an improvement in the 4-year overall survival rate from 86% (AS+RT) to 93% (AS+RT+CT). Assuming an exponential survival distribution for each arm, then an absolute improvement of 7% in the 4-year overall survival rate translates to a 51% relative reduction (hazard ratio 0.49) in the yearly death rate. Under a 1-sided significance level of 0.05 and 90% power, at least 78 deaths and 486 cases were required to perform the primary endpoint analysis.|
1753533|NCT00288015|3223134|Other|This is a two-stage optimal simon design. If bevacizumab is not effective, there is a 0.050 probability of concluding that it is. If bevacizumab is effective, there is a 0.2000 probability of concluding that it is not.||||||||||||||||This is a two stage optimal simon design testing the Null hypothesis: bevacizumab is not effective with P<=0.220 and the alternative hypothesis: bevacizumab is effective with P >=0.450 and has a sample size of 16.96 and a probability of early termination of 0.739. p=probability (progression free survival - PFS time>/=3 months).|P<=0.220 is the threshold value of significance that the null hypothesis is true or the alternative hypothesis is true. P Value was not calculated from the data. Median survival time was calculated using a 20% censored Kaplan-Meier table and graph.
1753534|NCT00287716|3223150|Superiority or Other||Hazard Ratio (HR)|0.84||||0.515|2-Sided|95.0|0.5|1.42|||Log Rank|||The null hypothesis is that there is no treatment difference between the pirfenidone 2403-mg/d treatment group and the placebo treatment group.|
1753535|NCT00287716|3223156|Superiority or Other||Hazard Ratio (HR)|0.64||||0.023|2-Sided|95.0|0.44|0.95|||Log Rank|||The null hypothesis is that there is no treatment difference between the pirfenidone 2403 mg/day treatment group and the placebo treatment group.|
1753536|NCT00287222|3223184|Superiority or Other||percentage progression free at 27 weeks|28.0|Standard Error of the Mean|10.97||0.0006|2-Sided|95.0|10.0|53.0|||one-sided exact binomial test|||Estimating the percentage of participants that remain free of disease progression at 27 weeks from the onset of treatment, and testing that proportion against a null-hypothesis proportion of 0.04 using the one-sided exact binomial test at 5% alpha, based upon historical data from the literature.|
1753537|NCT00286754|3223197|Superiority or Other|||||||0.502||||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared||||
1753538|NCT00286754|3223197|Superiority or Other|||||||0.581||||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared||||
1753539|NCT00286754|3223198|Superiority or Other|||||||0.333||||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared||||
1753540|NCT00286754|3223198|Superiority or Other|||||||0.012||||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared||||
1753541|NCT00286754|3223199|Superiority or Other|||||||0.638||||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared||||
1753542|NCT00286754|3223199|Superiority or Other|||||||0.011||||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Chi-squared||||
1753543|NCT00286754|3223200|Superiority or Other|||||||0.205|||||||Wilcoxon (Mann-Whitney)||||
1753544|NCT00286754|3223200|Superiority or Other|||||||0.306||||||Since we are performing 3 tests, we will adjust the type I error to 0.017|Wilcoxon (Mann-Whitney)||||
1753545|NCT00286754|3223201|Superiority or Other|||||||0.318||||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)||||
1753547|NCT00286754|3223202|Superiority or Other|||||||0.9||||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)||||
1753548|NCT00286754|3223202|Superiority or Other|||||||0.008||||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)||||
1753549|NCT00286754|3223202|Superiority or Other||||||<|0.009||||||Change in SBP were compared by treatment arm using a 1.67% type I error (Bonferroni adjustment), ie, 1.67% for each of the 3 comparisons by arm (6-month-baseline for SMI, HEI and UC separately).|Wilcoxon (Mann-Whitney)||||
1753550|NCT00286754|3223203|Superiority or Other|||||||0.89||||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar||||
1753551|NCT00286754|3223203|Superiority or Other|||||||0.012||||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar||||
1753552|NCT00286754|3223203|Superiority or Other||||||<|3e-06||||||Change in BP control were compared by treatment arm using a 1.67% type I error (with Bonferroni adjustment), ie, 1.67% for each assessment of change in proportion with BP under control from baseline to 6 months by SMI, HEI or UC (3 tests).|McNemar||||
1753553|NCT00286754|3223204|Superiority or Other|||||||0.047||||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI vs UC for BP control and SBP separately). This p-value is for comparison of HEI vs. UC|Wilcoxon (Mann-Whitney)||||
1753554|NCT00286754|3223204|Superiority or Other|||||||0.009||||||BP control and SBP were compared at 6 months across treatment arms using a 2.5% type I error (Bonferroni adjustment), 1.25% for each of the 4 comparisons (SMI versus UC and HEI vs UC for BP control and SBP separately). This p-value is for SMI vs UC|Wilcoxon (Mann-Whitney)|||The study was designed as an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. The study was not powered to test comparisons between the 2 active intervention arms.|
1753555|NCT00286754|3223205|Superiority or Other|||||||0.108||||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI versus UC for BP control and SBP separately). This p-value is for comparison of HEI vs. UC|Wilcoxon (Mann-Whitney)||||
1753556|NCT00286754|3223205|Superiority or Other|||||||0.001||||||BP control and SBP were compared at 6 months across treatment arms using a Bonferroni adjustment of 1.25% for each of the 4 comparisons (SMI versus UC and HEI versus UC for BP control and SBP separately). This p-value is for comparison of SMI vs. UC|Wilcoxon (Mann-Whitney)|||The study was an effectiveness trial of 2 active interventions, each compared with an active standard of care control group. We expected that 54% of patients on BP-lowering therapy would be properly controlled with HEI and 43% with UC, whereas we expected SMI to increase this to 69% control in 6 months. BP control and SBP were compared at 6 months across treatment arms using a 2.5% type I error (Bonferroni adjustment), ie, 1.25% for each of the 4 comparisons.|
1753557|NCT00286741|3223207|Superiority or Other|||||||0.03|||||||Mixed Models Analysis||||
1753558|NCT00286741|3223208|Superiority or Other|||||||0.15|||||||Mixed Models Analysis||||
1753559|NCT00286494|3223211|Superiority or Other||Mean Difference (Final Values)|0.05||||0.9|2-Sided|95.0|-0.74|0.84||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753560|NCT00286494|3223211|Superiority or Other||Mean Difference (Final Values)|0.42||||0.294|2-Sided|95.0|-0.37|1.22||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753561|NCT00286494|3223212|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.985|2-Sided|95.0|-0.77|0.76||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753562|NCT00286494|3223212|Superiority or Other||Mean Difference (Final Values)|0.2||||0.607|2-Sided|95.0|-0.56|0.96||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753563|NCT00286494|3223213|Superiority or Other||Mean Difference (Final Values)|0.03||||0.922|2-Sided|95.0|-0.61|0.67||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753564|NCT00286494|3223213|Superiority or Other||Mean Difference (Final Values)|0.14||||0.672|2-Sided|95.0|-0.5|0.78||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753565|NCT00286494|3223214|Superiority or Other||Mean Difference (Final Values)|0.03||||0.906|2-Sided|95.0|-0.52|0.58||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1755491|NCT00265616|3225329|Superiority or Other|||||||1|||||||Fisher Exact||||
1753566|NCT00286494|3223214|Superiority or Other||Mean Difference (Final Values)|0.1||||0.718|2-Sided|95.0|-0.45|0.65||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose,baseline value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753567|NCT00286494|3223215|Superiority or Other||Odds Ratio (OR)|2.849||||0.146|2-Sided|95.0|0.696|11.672|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753568|NCT00286494|3223215|Superiority or Other||Odds Ratio (OR)|1.959||||0.364|2-Sided|95.0|0.459|8.362|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753569|NCT00286494|3223216|Superiority or Other||Odds Ratio (OR)|5.196||||0.002|2-Sided|95.0|1.806|14.95|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753570|NCT00286494|3223216|Superiority or Other||Odds Ratio (OR)|3.8||||0.015|2-Sided|95.0|1.3|11.107|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753571|NCT00286494|3223217|Superiority or Other||Odds Ratio (OR)|4.693|||<|0.001|2-Sided|95.0|2.303|9.56|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753572|NCT00286494|3223217|Superiority or Other||Odds Ratio (OR)|3.67|||<|0.001|2-Sided|95.0|1.789|7.532|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753573|NCT00286494|3223218|Superiority or Other||Odds Ratio (OR)|5.247|||<|0.001|2-Sided|95.0|3.027|9.094|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753574|NCT00286494|3223218|Superiority or Other||Odds Ratio (OR)|4.134|||<|0.001|2-Sided|95.0|2.392|7.146|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753575|NCT00286494|3223219|Superiority or Other||Odds Ratio (OR)|3.917|||<|0.001|2-Sided|95.0|2.147|7.146|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753576|NCT00286494|3223219|Superiority or Other||Odds Ratio (OR)|2.783|||<|0.001|2-Sided|95.0|1.547|5.005|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753577|NCT00286494|3223220|Superiority or Other||Odds Ratio (OR)|2.301||||0.005|2-Sided|95.0|1.291|4.1|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regiment & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753578|NCT00286494|3223220|Superiority or Other||Odds Ratio (OR)|1.903||||0.029|2-Sided|95.0|1.067|3.393|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753579|NCT00286494|3223221|Superiority or Other||Odds Ratio (OR)|5.533|||<|0.001|2-Sided|95.0|2.017|15.176|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753580|NCT00286494|3223221|Superiority or Other||Odds Ratio (OR)|4.815|||<|0.003|2-Sided|95.0|1.736|13.358|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753581|NCT00286494|3223222|Superiority or Other||Mean Difference (Final Values)|0.223||||0.089|2-Sided|95.0|-0.034|0.479||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753582|NCT00286494|3223222|Superiority or Other||Mean Difference (Final Values)|0.123||||0.349|2-Sided|95.0|-0.134|0.38||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753583|NCT00286494|3223223|Superiority or Other||Mean Difference (Final Values)|0.131||||0.296|2-Sided|95.0|-0.115|0.378||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753584|NCT00286494|3223223|Superiority or Other||Mean Difference (Final Values)|0.026||||0.835|2-Sided|95.0|-0.221|0.273||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753585|NCT00286494|3223224|Superiority or Other||Mean Difference (Final Values)|0.238||||0.086|2-Sided|95.0|-0.033|0.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753586|NCT00286494|3223224|Superiority or Other||Mean Difference (Final Values)|0.22||||0.114|2-Sided|95.0|-0.053|0.492||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753587|NCT00286494|3223225|Superiority or Other||Mean Difference (Final Values)|-0.051||||0.735|2-Sided|95.0|-0.344|0.243||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753588|NCT00286494|3223225|Superiority or Other||Mean Difference (Final Values)|-0.068||||0.649|2-Sided|95.0|-0.363|0.226||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753589|NCT00286494|3223226|Superiority or Other||Mean Difference (Final Values)|0.135||||0.327|2-Sided|95.0|-0.135|0.405||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753590|NCT00286494|3223226|Superiority or Other||Mean Difference (Final Values)|-0.006||||0.967|2-Sided|95.0|-0.277|0.265||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753591|NCT00286494|3223227|Superiority or Other||Mean Difference (Final Values)|0.056||||0.683|2-Sided|95.0|-0.212|0.324||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753592|NCT00286494|3223227|Superiority or Other||Mean Difference (Final Values)|-0.012||||0.928|2-Sided|95.0|-0.28|0.255||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753593|NCT00286494|3223228|Superiority or Other||Mean Difference (Final Values)|-0.038||||0.093|2-Sided|95.0|-0.082|0.006||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753594|NCT00286494|3223228|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.028|2-Sided|95.0|-0.095|-0.005||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753595|NCT00286494|3223229|Superiority or Other||Mean Difference (Final Values)|-0.051||||0.012|2-Sided|95.0|-0.092|-0.011||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753596|NCT00286494|3223229|Superiority or Other||Mean Difference (Final Values)|-0.059||||0.004|2-Sided|95.0|-0.1|-0.019||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753597|NCT00286494|3223230|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.105|2-Sided|95.0|-0.067|0.006||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753598|NCT00286494|3223230|Superiority or Other||Mean Difference (Final Values)|-0.027||||0.144|2-Sided|95.0|-0.064|0.009||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753599|NCT00286494|3223231|Superiority or Other||Mean Difference (Final Values)|-0.057||||0.014|2-Sided|95.0|-0.102|-0.012||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1755492|NCT00265395|3225340|Superiority or Other||SVR Rate Difference|-4.9||||0.6445||95.0|-20.4|10.6|||Asymptotic Z-test||||
1753600|NCT00286494|3223231|Superiority or Other||Mean Difference (Final Values)|-0.046||||0.05|2-Sided|95.0|-0.092|0.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753601|NCT00286494|3223232|Superiority or Other||Mean Difference (Final Values)|-0.051||||0.004|2-Sided|95.0|-0.086|-0.016||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753602|NCT00286494|3223232|Superiority or Other||Mean Difference (Final Values)|-0.049||||0.006|2-Sided|95.0|-0.084|-0.014||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753603|NCT00286494|3223233|Superiority or Other||Mean Difference (Final Values)|-0.059||||0.001|2-Sided|95.0|-0.093|-0.024||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753604|NCT00286494|3223233|Superiority or Other||Mean Difference (Final Values)|-0.057||||0.001|2-Sided|95.0|-0.092|-0.022||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753605|NCT00286494|3223234|Superiority or Other||Mean Difference (Final Values)|0.81||||0.352|2-Sided|95.0|-0.89|2.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753606|NCT00286494|3223234|Superiority or Other||Mean Difference (Final Values)|0.61||||0.483|2-Sided|95.0|-1.1|2.33||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753607|NCT00286494|3223235|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.867|2-Sided|95.0|-1.79|1.51||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753608|NCT00286494|3223235|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.807|2-Sided|95.0|-1.87|1.46||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753609|NCT00286494|3223236|Superiority or Other||Mean Difference (Final Values)|0.69||||0.423|2-Sided|95.0|-1.0|2.38||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753610|NCT00286494|3223236|Superiority or Other||Mean Difference (Final Values)|0.75||||0.39|2-Sided|95.0|-0.96|2.45||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753611|NCT00286494|3223237|Superiority or Other||Mean Difference (Final Values)|-0.58||||0.662|2-Sided|95.0|-3.18|2.02||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753612|NCT00286494|3223237|Superiority or Other||Mean Difference (Final Values)|0.44||||0.743|2-Sided|95.0|-2.18|3.06||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753613|NCT00286494|3223238|Superiority or Other||Mean Difference (Final Values)|0.38||||0.674|2-Sided|95.0|-1.41|2.17||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753614|NCT00286494|3223238|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.478|2-Sided|95.0|-2.46|1.15||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753615|NCT00286494|3223239|Superiority or Other||Mean Difference (Final Values)|-0.88||||0.303|2-Sided|95.0|-2.56|0.8||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753616|NCT00286494|3223239|Superiority or Other||Mean Difference (Final Values)|-0.99||||0.249|2-Sided|95.0|-2.68|0.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753617|NCT00286494|3223240|Superiority or Other||Mean Difference (Final Values)|-0.6||||0.782|2-Sided|95.0|-5.2|3.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753618|NCT00286494|3223240|Superiority or Other||Mean Difference (Final Values)|-4.1||||0.08|2-Sided|95.0|-8.6|0.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753619|NCT00286494|3223241|Superiority or Other||Mean Difference (Final Values)|-3.0||||0.143|2-Sided|95.0|-7.0|1.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753620|NCT00286494|3223241|Superiority or Other||Mean Difference (Final Values)|-5.3||||0.009|2-Sided|95.0|-9.4|-1.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753621|NCT00286494|3223242|Superiority or Other||Mean Difference (Final Values)|0.0||||0.993|2-Sided|95.0|-4.5|4.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753622|NCT00286494|3223242|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.884|2-Sided|95.0|-4.9|4.2||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753623|NCT00286494|3223243|Superiority or Other||Mean Difference (Final Values)|-4.4||||0.056|2-Sided|95.0|-8.9|0.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753624|NCT00286494|3223243|Superiority or Other||Mean Difference (Final Values)|-4.2||||0.068|2-Sided|95.0|-8.8|0.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753625|NCT00286494|3223244|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.489|2-Sided|95.0|-5.5|2.6||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753626|NCT00286494|3223244|Superiority or Other||Mean Difference (Final Values)|-4.2||||0.043|2-Sided|95.0|-8.3|-0.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753627|NCT00286494|3223245|Superiority or Other||Mean Difference (Final Values)|-4.9||||0.023|2-Sided|95.0|-9.1|-0.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753628|NCT00286494|3223245|Superiority or Other||Mean Difference (Final Values)|-6.4||||0.003|2-Sided|95.0|-10.6|-2.1||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753629|NCT00286494|3223246|Superiority or Other||Odds Ratio (OR)|0.658||||0.315|2-Sided|95.0|0.292|1.487|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753630|NCT00286494|3223246|Superiority or Other||Odds Ratio (OR)|0.628||||0.266|2-Sided|95.0|0.277|1.425||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753631|NCT00286494|3223247|Superiority or Other||Odds Ratio (OR)|0.235|||<|0.001|2-Sided|95.0|0.126|0.438||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1755493|NCT00265317|3225377|Superiority or Other|||||||0.3945||||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test||||
1753632|NCT00286494|3223247|Superiority or Other||Odds Ratio (OR)|0.271|||<|0.001|2-Sided|95.0|0.147|0.499||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline pioglitazone dose, baseline treatment regimen, & baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753633|NCT00286494|3223248|Superiority or Other||Mean Difference (Final Values)|-14.1||||0.003|2-Sided|95.0|-23.3|-5.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753634|NCT00286494|3223248|Superiority or Other||Mean Difference (Final Values)|-13.9||||0.003|2-Sided|95.0|-23.1|-4.8||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753635|NCT00286494|3223249|Superiority or Other||Mean Difference (Final Values)|-15.2|||<|0.001|2-Sided|95.0|-23.8|-6.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753636|NCT00286494|3223249|Superiority or Other||Mean Difference (Final Values)|-15.6|||<|0.001|2-Sided|95.0|-24.2|-6.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753637|NCT00286494|3223250|Superiority or Other||Mean Difference (Final Values)|-14.4||||0.002|2-Sided|95.0|-23.3|-5.5||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753638|NCT00286494|3223250|Superiority or Other||Mean Difference (Final Values)|-10.0||||0.029|2-Sided|95.0|-18.9|-1.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753639|NCT00286494|3223251|Superiority or Other||Mean Difference (Final Values)|-16.3|||<|0.001|2-Sided|95.0|-24.3|-8.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753640|NCT00286494|3223251|Superiority or Other||Mean Difference (Final Values)|-10.4|||<|0.011|2-Sided|95.0|-18.5|-2.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753641|NCT00286494|3223252|Superiority or Other||Mean Difference (Final Values)|-21.1|||<|0.001|2-Sided|95.0|-28.9|-13.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753642|NCT00286494|3223252|Superiority or Other||Mean Difference (Final Values)|-16.5|||<|0.001|2-Sided|95.0|-24.4|-8.7||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753643|NCT00286494|3223253|Superiority or Other||Mean Difference (Final Values)|-23.0|||<|0.001|2-Sided|95.0|-29.9|-16.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753644|NCT00286494|3223253|Superiority or Other||Mean Difference (Final Values)|-20.6|||<|0.001|2-Sided|95.0|-27.5|-13.6||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753645|NCT00286494|3223254|Superiority or Other||Mean Difference (Final Values)|-19.4|||<|0.001|2-Sided|95.0|-26.6|-12.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753646|NCT00286494|3223254|Superiority or Other||Mean Difference (Final Values)|-19.2|||<|0.001|2-Sided|95.0|-26.4|-11.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753676|NCT00286468|3223269|Superiority or Other||Odds Ratio (OR)|2.994|||<|0.001|2-Sided|95.0|1.72|5.213||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753647|NCT00286494|3223255|Superiority or Other||Mean Difference (Final Values)|-15.5|||<|0.001|2-Sided|95.0|-23.0|-8.0||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753648|NCT00286494|3223255|Superiority or Other||Mean Difference (Final Values)|-11.4|||<|0.003|2-Sided|95.0|-18.9|-3.9||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753649|NCT00286494|3223256|Superiority or Other||Mean Difference (Final Values)|-0.55|||<|0.001|2-Sided|95.0|-0.74|-0.36||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753650|NCT00286494|3223256|Superiority or Other||Mean Difference (Final Values)|-0.41|||<|0.001|2-Sided|95.0|-0.6|-0.22||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753651|NCT00286494|3223257|Superiority or Other||Mean Difference (Final Values)|-0.58|||<|0.001|2-Sided|95.0|-0.76|-0.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753652|NCT00286494|3223257|Superiority or Other||Mean Difference (Final Values)|-0.45|||<|0.001|2-Sided|95.0|-0.63|-0.26||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753653|NCT00286494|3223258|Superiority or Other||Mean Difference (Final Values)|-0.59|||<|0.001|2-Sided|95.0|-0.75|-0.43||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753654|NCT00286494|3223258|Superiority or Other||Mean Difference (Final Values)|-0.46|||<|0.001|2-Sided|95.0|-0.63|-0.3||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753655|NCT00286494|3223259|Superiority or Other||Mean Difference (Final Values)|-0.55|||<|0.001|2-Sided|95.0|-0.69|-0.4||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753656|NCT00286494|3223259|Superiority or Other||Mean Difference (Final Values)|-0.42|||<|0.001|2-Sided|95.0|-0.56|-0.27||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753657|NCT00286494|3223260|Superiority or Other||Mean Difference (Final Values)|-0.31|||<|0.001|2-Sided|95.0|-0.41|-0.21||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753658|NCT00286494|3223260|Superiority or Other||Mean Difference (Final Values)|-0.26|||<|0.001|2-Sided|95.0|-0.36|-0.16||No multiplicity adjustments.|ANCOVA|Treatment, geographic region and baseline treatment regimen as class variables; baseline pioglitazone dose and value for endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753659|NCT00286494|3223261|Superiority or Other||Mean Difference (Final Values)|-0.61|||<|0.001|2-Sided|95.0|-0.8|-0.41||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided >0.05 significance level and >=80% of subjects meeting per protocol criteria.|
1753677|NCT00286468|3223270|Superiority or Other||Odds Ratio (OR)|3.707|||<|0.001|2-Sided|95.0|2.012|6.831||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1754097|NCT00285012|3223507|Superiority or Other|||||||0.063|||||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Functional State|
1757158|NCT00241904|3227578|Superiority|||||||0.003|||||||General Linear Mixed Model||||
1753660|NCT00286494|3223261|Superiority or Other||Mean Difference (Final Values)|-0.47|||<|0.001|2-Sided|95.0|-0.67|-0.28||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment, treatment regimen and geographic region as class variables; baseline pioglitazone dose and baseline value for the endpoint as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=500 subjects had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided >0.05 significance level and >=80% of subjects meeting per protocol criteria.|
1753661|NCT00286468|3223262|Superiority or Other||Mean Difference (Final Values)|0.88||||0.01|2-Sided|95.0|0.21|1.54||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753662|NCT00286468|3223262|Superiority or Other||Mean Difference (Final Values)|0.8||||0.018|2-Sided|95.0|0.14|1.46||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753663|NCT00286468|3223263|Superiority or Other||Mean Difference (Final Values)|0.91||||0.005|2-Sided|95.0|0.28|1.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753664|NCT00286468|3223263|Superiority or Other||Mean Difference (Final Values)|1.1|||<|0.001|2-Sided|95.0|0.47|1.73||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753665|NCT00286468|3223264|Superiority or Other||Mean Difference (Final Values)|0.52||||0.04|2-Sided|95.0|0.02|1.01||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753666|NCT00286468|3223264|Superiority or Other||Mean Difference (Final Values)|0.69||||0.006|2-Sided|95.0|0.2|1.18||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753667|NCT00286468|3223265|Superiority or Other||Mean Difference (Final Values)|0.59||||0.006|2-Sided|95.0|0.17|1.02||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753668|NCT00286468|3223265|Superiority or Other||Mean Difference (Final Values)|0.74|||<|0.001|2-Sided|95.0|0.32|1.16||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753669|NCT00286468|3223266|Superiority or Other|||||||0.178||||||no multiplicity adjustments|Mantel Haenszel|OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.|||
1753670|NCT00286468|3223266|Superiority or Other|||||||0.626||||||no multiplicity adjustments|Mantel Haenszel|OR and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.|||
1753671|NCT00286468|3223267|Superiority or Other||Odds Ratio (OR)|2.05||||0.131|2-Sided|95.0|0.808|5.203||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753672|NCT00286468|3223267|Superiority or Other||Odds Ratio (OR)|0.991||||0.986|2-Sided|95.0|0.365|2.689||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753673|NCT00286468|3223268|Superiority or Other||Odds Ratio (OR)|3.416|||<|0.001|2-Sided|95.0|1.703|6.851||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753674|NCT00286468|3223268|Superiority or Other||Odds Ratio (OR)|1.776|||<|0.115|2-Sided|95.0|0.87|3.627||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753675|NCT00286468|3223269|Superiority or Other||Odds Ratio (OR)|3.401|||<|0.001|2-Sided|95.0|1.95|5.933||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1754098|NCT00285012|3223507|Superiority or Other|||||||0.29|||||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Functional State|
1753678|NCT00286468|3223270|Superiority or Other||Odds Ratio (OR)|1.955|||<|0.025|2-Sided|95.0|1.086|3.519||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753679|NCT00286468|3223271|Superiority or Other||Odds Ratio (OR)|2.505||||0.005|2-Sided|95.0|1.313|4.78||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753680|NCT00286468|3223271|Superiority or Other||Odds Ratio (OR)|1.925||||0.046|2-Sided|95.0|1.011|3.666||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753681|NCT00286468|3223272|Superiority or Other||Odds Ratio (OR)|1.96||||0.148|2-Sided|95.0|0.787|4.885||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753682|NCT00286468|3223272|Superiority or Other||Odds Ratio (OR)|1.29||||0.596|2-Sided|95.0|0.503|3.306||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753683|NCT00286468|3223273|Superiority or Other||Mean Difference (Final Values)|0.063||||0.698|2-Sided|95.0|-0.255|0.381||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753684|NCT00286468|3223273|Superiority or Other||Mean Difference (Final Values)|0.075||||0.642|2-Sided|95.0|-0.242|0.393||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753685|NCT00286468|3223274|Superiority or Other||Mean Difference (Final Values)|0.138||||0.376|2-Sided|95.0|-0.168|0.444||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753686|NCT00286468|3223274|Superiority or Other||Mean Difference (Final Values)|0.015||||0.924|2-Sided|95.0|-0.29|0.32||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753687|NCT00286468|3223275|Superiority or Other||Mean Difference (Final Values)|0.159||||0.28|2-Sided|95.0|-0.13|0.448||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753688|NCT00286468|3223275|Superiority or Other||Mean Difference (Final Values)|0.228||||0.121|2-Sided|95.0|-0.06|0.517||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753689|NCT00286468|3223276|Superiority or Other||Mean Difference (Final Values)|0.226||||0.11|2-Sided|95.0|-0.051|0.502||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753690|NCT00286468|3223276|Superiority or Other||Mean Difference (Final Values)|0.182||||0.196|2-Sided|95.0|-0.094|0.458||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753691|NCT00286468|3223277|Superiority or Other||Mean Difference (Final Values)|0.349||||0.012|2-Sided|95.0|0.077|0.621||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753692|NCT00286468|3223277|Superiority or Other||Mean Difference (Final Values)|0.268||||0.053|2-Sided|95.0|-0.004|0.54||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753693|NCT00286468|3223278|Superiority or Other||Mean Difference (Final Values)|0.176||||0.284|2-Sided|95.0|-0.147|0.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753694|NCT00286468|3223278|Superiority or Other||Mean Difference (Final Values)|0.162||||0.324|2-Sided|95.0|-0.161|0.486||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753695|NCT00286468|3223279|Superiority or Other||Mean Difference (Final Values)|-0.026||||0.177|2-Sided|95.0|-0.065|0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753696|NCT00286468|3223279|Superiority or Other||Mean Difference (Final Values)|-0.026||||0.177|2-Sided|95.0|-0.065|0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753697|NCT00286468|3223280|Superiority or Other||Mean Difference (Final Values)|-0.031||||0.135|2-Sided|95.0|-0.071|0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753698|NCT00286468|3223280|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.148|2-Sided|95.0|-0.069|0.01||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753699|NCT00286468|3223281|Superiority or Other||Mean Difference (Final Values)|-0.043||||0.041|2-Sided|95.0|-0.084|-0.002||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753700|NCT00286468|3223281|Superiority or Other||Mean Difference (Final Values)|-0.039||||0.062|2-Sided|95.0|-0.08|0.002||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753701|NCT00286468|3223282|Superiority or Other||Mean Difference (Final Values)|-0.038||||0.055|2-Sided|95.0|-0.077|0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753702|NCT00286468|3223282|Superiority or Other||Mean Difference (Final Values)|-0.028||||0.159|2-Sided|95.0|-0.067|0.011||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753703|NCT00286468|3223283|Superiority or Other||Mean Difference (Final Values)|-0.037||||0.059|2-Sided|95.0|-0.074|0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753704|NCT00286468|3223283|Superiority or Other||Mean Difference (Final Values)|-0.044||||0.024|2-Sided|95.0|-0.081|-0.006||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753705|NCT00286468|3223284|Superiority or Other||Mean Difference (Final Values)|-0.035||||0.116|2-Sided|95.0|-0.078|0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753706|NCT00286468|3223284|Superiority or Other||Mean Difference (Final Values)|-0.056||||0.011|2-Sided|95.0|-0.099|-0.013||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753707|NCT00286468|3223285|Superiority or Other||Mean Difference (Final Values)|2.03||||0.124|2-Sided|95.0|-0.56|4.61||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753708|NCT00286468|3223285|Superiority or Other||Mean Difference (Final Values)|1.04||||0.43|2-Sided|95.0|-1.54|3.62||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753709|NCT00286468|3223286|Superiority or Other||Mean Difference (Final Values)|0.99||||0.559|2-Sided|95.0|-2.34|4.32||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753710|NCT00286468|3223286|Superiority or Other||Mean Difference (Final Values)|1.25||||0.461|2-Sided|95.0|-2.08|4.57||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1754133|NCT00283712|3223584|Superiority or Other||Mean Difference (Final Values)|0.0||||1|2-Sided|90.0|-0.3|0.3|||Fisher Exact||||
1753711|NCT00286468|3223287|Superiority or Other||Mean Difference (Final Values)|1.72||||0.303|2-Sided|95.0|-1.55|4.99||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753712|NCT00286468|3223287|Superiority or Other||Mean Difference (Final Values)|2.95||||0.077|2-Sided|95.0|-0.32|6.22||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753713|NCT00286468|3223288|Superiority or Other||Mean Difference (Final Values)|1.02||||0.568|2-Sided|95.0|-2.48|4.52||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753714|NCT00286468|3223288|Superiority or Other||Mean Difference (Final Values)|1.35||||0.448|2-Sided|95.0|-2.14|4.85||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753715|NCT00286468|3223289|Superiority or Other||Mean Difference (Final Values)|1.19||||0.38|2-Sided|95.0|-1.48|3.86||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753716|NCT00286468|3223289|Superiority or Other||Mean Difference (Final Values)|0.19||||0.89|2-Sided|95.0|-2.47|2.85||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753717|NCT00286468|3223290|Superiority or Other||Mean Difference (Final Values)|1.51||||0.332|2-Sided|95.0|-1.54|4.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753718|NCT00286468|3223290|Superiority or Other||Mean Difference (Final Values)|1.26||||0.415|2-Sided|95.0|-1.78|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753719|NCT00286468|3223291|Superiority or Other||Mean Difference (Final Values)|-0.1||||0.986|2-Sided|95.0|-6.3|6.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753720|NCT00286468|3223291|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.548|2-Sided|95.0|-8.1|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753721|NCT00286468|3223292|Superiority or Other||Mean Difference (Final Values)|2.5||||0.432|2-Sided|95.0|-3.8|8.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753722|NCT00286468|3223292|Superiority or Other||Mean Difference (Final Values)|0.4||||0.894|2-Sided|95.0|-5.9|6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753723|NCT00286468|3223293|Superiority or Other||Mean Difference (Final Values)|0.7||||0.826|2-Sided|95.0|-5.6|7.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753724|NCT00286468|3223293|Superiority or Other||Mean Difference (Final Values)|0.4||||0.908|2-Sided|95.0|-5.9|6.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753725|NCT00286468|3223294|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.957|2-Sided|95.0|-6.1|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753726|NCT00286468|3223294|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.953|2-Sided|95.0|-6.1|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753727|NCT00286468|3223295|Superiority or Other||Mean Difference (Final Values)|3.3||||0.305|2-Sided|95.0|-3.0|9.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753728|NCT00286468|3223295|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.916|2-Sided|95.0|-6.6|5.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753729|NCT00286468|3223296|Superiority or Other||Mean Difference (Final Values)|3.7||||0.259|2-Sided|95.0|-2.7|10.1||No multiplicity adjustments.|Regression, Logistic|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753730|NCT00286468|3223296|Superiority or Other||Mean Difference (Final Values)|0.3||||0.923|2-Sided|95.0|-6.1|6.7||No multiplicity adjustments.|Regression, Logistic|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753731|NCT00286468|3223297|Superiority or Other||Odds Ratio (OR)|0.372||||0.003|2-Sided|95.0|0.193|0.718||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753732|NCT00286468|3223297|Superiority or Other||Odds Ratio (OR)|0.374||||0.003|2-Sided|95.0|0.194|0.72||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753733|NCT00286468|3223298|Superiority or Other||Odds Ratio (OR)|0.521||||0.016|2-Sided|95.0|0.306|0.887||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753734|NCT00286468|3223298|Superiority or Other||Odds Ratio (OR)|0.775||||0.338|2-Sided|95.0|0.46|1.306||no multiplicity adjustments|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline glyburide dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753735|NCT00286468|3223299|Superiority or Other||Mean Difference (Final Values)|-10.5||||0.072|2-Sided|95.0|-22.0|0.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753736|NCT00286468|3223299|Superiority or Other||Mean Difference (Final Values)|-6.8||||0.241|2-Sided|95.0|-18.3|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753737|NCT00286468|3223300|Superiority or Other||Mean Difference (Final Values)|-13.3||||0.014|2-Sided|95.0|-23.9|-2.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753738|NCT00286468|3223300|Superiority or Other||Mean Difference (Final Values)|-9.0||||0.097|2-Sided|95.0|-19.6|1.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753739|NCT00286468|3223301|Superiority or Other||Mean Difference (Final Values)|-6.0||||0.228|2-Sided|95.0|-15.7|3.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753740|NCT00286468|3223301|Superiority or Other||Mean Difference (Final Values)|-1.9||||0.701|2-Sided|95.0|-11.6|7.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753741|NCT00286468|3223302|Superiority or Other||Mean Difference (Final Values)|-11.7||||0.012|2-Sided|95.0|-20.8|-2.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753742|NCT00286468|3223302|Superiority or Other||Mean Difference (Final Values)|-10.1||||0.03|2-Sided|95.0|-19.2|-1.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1754099|NCT00285012|3223507|Superiority or Other|||||||0.581|||||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Functional State|
1757601|NCT00227903|3228416|Superiority or Other (legacy)|||||||0.1|||||||Mixed Models Analysis||||
1753743|NCT00286468|3223303|Superiority or Other||Mean Difference (Final Values)|-15.4|||<|0.001|2-Sided|95.0|-23.9|-6.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753744|NCT00286468|3223303|Superiority or Other||Mean Difference (Final Values)|-16.7|||<|0.001|2-Sided|95.0|-25.2|-8.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753745|NCT00286468|3223304|Superiority or Other||Mean Difference (Final Values)|-17.4|||<|0.001|2-Sided|95.0|-25.8|-9.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753746|NCT00286468|3223304|Superiority or Other||Mean Difference (Final Values)|-10.9|||<|0.01|2-Sided|95.0|-19.3|-2.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753747|NCT00286468|3223305|Superiority or Other||Mean Difference (Final Values)|-20.0|||<|0.001|2-Sided|95.0|-27.7|-12.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753748|NCT00286468|3223305|Superiority or Other||Mean Difference (Final Values)|-14.9|||<|0.001|2-Sided|95.0|-22.5|-7.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753749|NCT00286468|3223306|Superiority or Other||Mean Difference (Final Values)|-19.3|||<|0.001|2-Sided|95.0|-28.0|-10.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753750|NCT00286468|3223306|Superiority or Other||Mean Difference (Final Values)|-12.1|||<|0.006|2-Sided|95.0|-20.8|-3.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753751|NCT00286468|3223307|Superiority or Other||Mean Difference (Final Values)|-0.52|||<|0.001|2-Sided|95.0|-0.71|-0.34||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753752|NCT00286468|3223307|Superiority or Other||Mean Difference (Final Values)|-0.36|||<|0.001|2-Sided|95.0|-0.54|-0.17||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753753|NCT00286468|3223308|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.001|2-Sided|95.0|-0.68|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753754|NCT00286468|3223308|Superiority or Other||Mean Difference (Final Values)|-0.37|||<|0.001|2-Sided|95.0|-0.54|-0.19||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753755|NCT00286468|3223309|Superiority or Other||Mean Difference (Final Values)|-0.52|||<|0.001|2-Sided|95.0|-0.68|-0.36||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753756|NCT00286468|3223309|Superiority or Other||Mean Difference (Final Values)|-0.41|||<|0.001|2-Sided|95.0|-0.57|-0.25||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753757|NCT00286468|3223310|Superiority or Other||Mean Difference (Final Values)|-0.47|||<|0.001|2-Sided|95.0|-0.61|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753758|NCT00286468|3223310|Superiority or Other||Mean Difference (Final Values)|-0.39|||<|0.001|2-Sided|95.0|-0.53|-0.26||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753759|NCT00286468|3223311|Superiority or Other||Mean Difference (Final Values)|-0.28|||<|0.001|2-Sided|95.0|-0.38|-0.18||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753760|NCT00286468|3223311|Superiority or Other||Mean Difference (Final Values)|-0.23|||<|0.001|2-Sided|95.0|-0.33|-0.13||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753761|NCT00286468|3223312|Superiority or Other||Mean Difference (Final Values)|-0.53|||<|0.001|2-Sided|95.0|-0.73|-0.33||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided >0.05 significance level and >=80% of subjects meeting per-protocol criteria.|
1753762|NCT00286468|3223312|Superiority or Other||Mean Difference (Final Values)|-0.39|||<|0.001|2-Sided|95.0|-0.59|-0.19||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; baseline glyburide dose and baseline value for glycosylated hemoglobin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=500 subjects had 94% power to detect a treatment difference as small as 0.4% in the supportive per-protocol analysis set assuming SD=0.8%, 2-sided >0.05 significance level, and >=80% of subjects meeting per protocol criteria.|
1753763|NCT00286455|3223313|Superiority or Other||Mean Difference (Final Values)|-2.8||||0.388|2-Sided|95.0|-9.3|3.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753764|NCT00286455|3223313|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.739|2-Sided|95.0|-7.4|5.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753765|NCT00286455|3223314|Superiority or Other||Mean Difference (Final Values)|2.0||||0.523|2-Sided|95.0|-4.1|8.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753766|NCT00286455|3223314|Superiority or Other||Mean Difference (Final Values)|1.8||||0.559|2-Sided|95.0|-4.2|7.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753767|NCT00286455|3223315|Superiority or Other||Mean Difference (Final Values)|0.9||||0.761|2-Sided|95.0|-5.2|7.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753768|NCT00286455|3223315|Superiority or Other||Mean Difference (Final Values)|0.9||||0.774|2-Sided|95.0|-5.1|6.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753769|NCT00286455|3223316|Superiority or Other||Mean Difference (Final Values)|4.0||||0.154|2-Sided|95.0|-1.5|9.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753770|NCT00286455|3223316|Superiority or Other||Mean Difference (Final Values)|2.0||||0.466|2-Sided|95.0|-3.4|7.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753771|NCT00286455|3223317|Superiority or Other||Mean Difference (Final Values)|1.0||||0.745|2-Sided|95.0|-4.8|6.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1754100|NCT00285012|3223507|Superiority or Other|||||||0.281|||||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Mental State|
1753772|NCT00286455|3223317|Superiority or Other||Mean Difference (Final Values)|0.3||||0.915|2-Sided|95.0|-5.3|6.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753773|NCT00286455|3223318|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.93|2-Sided|95.0|-6.4|5.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753774|NCT00286455|3223318|Superiority or Other||Mean Difference (Final Values)|1.5||||0.616|2-Sided|95.0|-4.4|7.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753775|NCT00286455|3223319|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.379|2-Sided|95.0|-1.29|0.49||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753776|NCT00286455|3223319|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.539|2-Sided|95.0|-1.16|0.61||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753777|NCT00286455|3223320|Superiority or Other||Mean Difference (Final Values)|0.0||||0.991|2-Sided|95.0|-0.73|0.74||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753778|NCT00286455|3223320|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.978|2-Sided|95.0|-0.74|0.72||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753779|NCT00286455|3223321|Superiority or Other||Mean Difference (Final Values)|0.3||||0.338|2-Sided|95.0|-0.32|0.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753780|NCT00286455|3223321|Superiority or Other||Mean Difference (Final Values)|-0.12||||0.702|2-Sided|95.0|-0.74|0.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753781|NCT00286455|3223322|Superiority or Other||Mean Difference (Final Values)|0.34||||0.237|2-Sided|95.0|-0.22|0.89||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753782|NCT00286455|3223322|Superiority or Other||Mean Difference (Final Values)|0.37||||0.186|2-Sided|95.0|-0.18|0.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753783|NCT00286455|3223323|Superiority or Other|||||||0.063||||||No multiplicity adjustments.|Mantel Haenszel|Odd's Ratio and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.|||
1753784|NCT00286455|3223323|Superiority or Other|||||||0.102||||||No multiplicity adjustments.|Mantel Haenszel|Odd's Ratio and 95% CI not estimable using logistic regression model. Tested using extended Mantel-Haenszel test.|||
1753785|NCT00286455|3223324|Superiority or Other||Odds Ratio (OR)|4.632||||0.029|2-Sided|95.0|1.169|18.354|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753786|NCT00286455|3223324|Superiority or Other||Odds Ratio (OR)|2.766||||0.153|2-Sided|95.0|0.685|11.16|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753787|NCT00286455|3223325|Superiority or Other||Odds Ratio (OR)|4.732||||0.001|2-Sided|95.0|1.862|12.025|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753788|NCT00286455|3223325|Superiority or Other||Odds Ratio (OR)|4.331||||0.002|2-Sided|95.0|1.714|10.947|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753789|NCT00286455|3223326|Superiority or Other||Odds Ratio (OR)|3.277|||<|0.001|2-Sided|95.0|1.671|6.429|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1754129|NCT00283842|3223575|Superiority or Other|||||||0.027|||||||Hochberg|||Statistical analysis provided for 400mg.|
1753790|NCT00286455|3223326|Superiority or Other||Odds Ratio (OR)|2.663|||<|0.004|2-Sided|95.0|1.367|5.188|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753791|NCT00286455|3223327|Superiority or Other||Odds Ratio (OR)|4.552|||<|0.001|2-Sided|95.0|2.068|10.017|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753792|NCT00286455|3223327|Superiority or Other||Odds Ratio (OR)|2.905|||<|0.006|2-Sided|95.0|1.359|6.21|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753793|NCT00286455|3223328|Superiority or Other||Odds Ratio (OR)|3.305||||0.003|2-Sided|95.0|1.505|7.255|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753794|NCT00286455|3223328|Superiority or Other||Odds Ratio (OR)|3.704||||0.001|2-Sided|95.0|1.694|8.1|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753795|NCT00286455|3223329|Superiority or Other||Odds Ratio (OR)|2.349||||0.091|2-Sided|95.0|0.873|6.321|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753796|NCT00286455|3223329|Superiority or Other||Odds Ratio (OR)|1.686||||0.305|2-Sided|95.0|0.622|4.571|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753797|NCT00286455|3223330|Superiority or Other||Mean Difference (Final Values)|0.003||||0.986|2-Sided|95.0|-0.332|0.338||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753798|NCT00286455|3223330|Superiority or Other||Mean Difference (Final Values)|-0.079||||0.642|2-Sided|95.0|-0.411|0.253||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753799|NCT00286455|3223331|Superiority or Other||Mean Difference (Final Values)|-0.036||||0.819|2-Sided|95.0|-0.347|0.275||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753800|NCT00286455|3223331|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.656|2-Sided|95.0|-0.378|0.239||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753801|NCT00286455|3223332|Superiority or Other||Mean Difference (Final Values)|-0.097||||0.645|2-Sided|95.0|-0.51|0.317||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753802|NCT00286455|3223332|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.886|2-Sided|95.0|-0.44|0.38||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753803|NCT00286455|3223333|Superiority or Other||Mean Difference (Final Values)|0.013||||0.949|2-Sided|95.0|-0.391|0.417||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753804|NCT00286455|3223333|Superiority or Other||Mean Difference (Final Values)|0.169||||0.408|2-Sided|95.0|-0.232|0.569||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753805|NCT00286455|3223334|Superiority or Other||Mean Difference (Final Values)|0.282||||0.203|2-Sided|95.0|-0.153|0.717||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753806|NCT00286455|3223334|Superiority or Other||Mean Difference (Final Values)|0.084||||0.703|2-Sided|95.0|-0.348|0.515||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753886|NCT00286442|3223374|Superiority or Other||Odds Ratio (OR)|1.404||||0.639|2-Sided|95.0|0.34|5.803||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1753807|NCT00286455|3223335|Superiority or Other||Mean Difference (Final Values)|-0.154||||0.393|2-Sided|95.0|-0.508|0.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753808|NCT00286455|3223335|Superiority or Other||Mean Difference (Final Values)|-0.216||||0.23|2-Sided|95.0|-0.568|0.137||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753809|NCT00286455|3223336|Superiority or Other||Mean Difference (Final Values)|-0.084||||0.002|2-Sided|95.0|-0.137|-0.032||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753810|NCT00286455|3223336|Superiority or Other||Mean Difference (Final Values)|-0.086||||0.001|2-Sided|95.0|-0.138|-0.034||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753811|NCT00286455|3223337|Superiority or Other||Mean Difference (Final Values)|-0.159||||0.001|2-Sided|95.0|-0.254|-0.065||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753812|NCT00286455|3223337|Superiority or Other||Mean Difference (Final Values)|-0.162|||<|0.001|2-Sided|95.0|-0.255|-0.069||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753813|NCT00286455|3223338|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.043|2-Sided|95.0|-0.079|-0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753814|NCT00286455|3223338|Superiority or Other||Mean Difference (Final Values)|-0.045||||0.021|2-Sided|95.0|-0.084|-0.007||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753815|NCT00286455|3223339|Superiority or Other||Mean Difference (Final Values)|-0.073|||<|0.001|2-Sided|95.0|-0.109|-0.037||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753816|NCT00286455|3223339|Superiority or Other||Mean Difference (Final Values)|-0.068|||<|0.001|2-Sided|95.0|-0.103|-0.032||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753817|NCT00286455|3223340|Superiority or Other||Mean Difference (Final Values)|-0.052||||0.001|2-Sided|95.0|-0.083|-0.021||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753818|NCT00286455|3223340|Superiority or Other||Mean Difference (Final Values)|-0.069|||<|0.001|2-Sided|95.0|-0.099|-0.038||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753819|NCT00286455|3223341|Superiority or Other||Mean Difference (Final Values)|-0.072|||<|0.001|2-Sided|95.0|-0.105|-0.038||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753820|NCT00286455|3223341|Superiority or Other||Mean Difference (Final Values)|-0.051|||<|0.003|2-Sided|95.0|-0.084|-0.018||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753821|NCT00286455|3223342|Superiority or Other||Mean Difference (Final Values)|0.09||||0.958|2-Sided|95.0|-3.28|3.46||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753822|NCT00286455|3223342|Superiority or Other||Mean Difference (Final Values)|0.24||||0.885|2-Sided|95.0|-3.09|3.58||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1754085|NCT00285779|3223487|Other||||||>|0.9999|||||||Fisher Exact||||
1754086|NCT00285779|3223488|Superiority or Other|||||||0.0978|||||||Fisher Exact||||
1753823|NCT00286455|3223343|Superiority or Other||Mean Difference (Final Values)|0.2||||0.899|2-Sided|95.0|-2.83|3.22||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753824|NCT00286455|3223343|Superiority or Other||Mean Difference (Final Values)|1.0||||0.514|2-Sided|95.0|-2.0|3.99||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753825|NCT00286455|3223344|Superiority or Other||Mean Difference (Final Values)|-1.04||||0.587|2-Sided|95.0|-4.82|2.74||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753826|NCT00286455|3223344|Superiority or Other||Mean Difference (Final Values)|0.97||||0.612|2-Sided|95.0|-2.78|4.71||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753827|NCT00286455|3223345|Superiority or Other||Mean Difference (Final Values)|0.06||||0.974|2-Sided|95.0|-3.46|3.57||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753828|NCT00286455|3223345|Superiority or Other||Mean Difference (Final Values)|2.6||||0.143|2-Sided|95.0|-0.88|6.08||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753829|NCT00286455|3223346|Superiority or Other||Mean Difference (Final Values)|1.29||||0.487|2-Sided|95.0|-2.35|4.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753830|NCT00286455|3223346|Superiority or Other||Mean Difference (Final Values)|1.54||||0.403|2-Sided|95.0|-2.07|5.14||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753831|NCT00286455|3223347|Superiority or Other||Mean Difference (Final Values)|-2.15||||0.218|2-Sided|95.0|-5.57|1.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753832|NCT00286455|3223347|Superiority or Other||Mean Difference (Final Values)|-0.73||||0.671|2-Sided|95.0|-4.14|2.67||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753833|NCT00286455|3223348|Superiority or Other||Mean Difference (Final Values)|-5.4||||0.129|2-Sided|95.0|-12.3|1.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753834|NCT00286455|3223348|Superiority or Other||Mean Difference (Final Values)|-4.0||||0.247|2-Sided|95.0|-10.9|2.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753835|NCT00286455|3223349|Superiority or Other||Mean Difference (Final Values)|-5.5||||0.104|2-Sided|95.0|-12.1|1.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753836|NCT00286455|3223349|Superiority or Other||Mean Difference (Final Values)|-5.2||||0.12|2-Sided|95.0|-11.7|1.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753837|NCT00286455|3223350|Superiority or Other||Mean Difference (Final Values)|-6.0||||0.152|2-Sided|95.0|-14.3|2.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753838|NCT00286455|3223350|Superiority or Other||Mean Difference (Final Values)|-3.9||||0.348|2-Sided|95.0|-12.1|4.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1754087|NCT00285584|3223490|Superiority or Other||Median Difference (Final Values)|-2.5||||0.19|||||||Wilcoxon (Mann-Whitney)||||
1753839|NCT00286455|3223351|Superiority or Other||Mean Difference (Final Values)|-5.7||||0.133|2-Sided|95.0|-13.2|1.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753840|NCT00286455|3223351|Superiority or Other||Mean Difference (Final Values)|-0.4||||0.917|2-Sided|95.0|-7.8|7.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753841|NCT00286455|3223352|Superiority or Other||Mean Difference (Final Values)|2.5||||0.571|2-Sided|95.0|-6.2|11.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753842|NCT00286455|3223352|Superiority or Other||Mean Difference (Final Values)|0.8||||0.85|2-Sided|95.0|-7.8|9.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753843|NCT00286455|3223353|Superiority or Other||Mean Difference (Final Values)|-13.3|||<|0.001|2-Sided|95.0|-21.1|-5.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753844|NCT00286455|3223353|Superiority or Other||Mean Difference (Final Values)|-7.6|||<|0.056|2-Sided|95.0|-15.3|0.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753845|NCT00286455|3223354|Superiority or Other||Odds Ratio (OR)|0.145|||<|0.001|2-Sided|95.0|0.052|0.405|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753846|NCT00286455|3223354|Superiority or Other||Odds Ratio (OR)|0.194|||<|0.001|2-Sided|95.0|0.073|0.516|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753847|NCT00286455|3223355|Superiority or Other||Odds Ratio (OR)|0.32||||0.008|2-Sided|95.0|0.138|0.739|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753848|NCT00286455|3223355|Superiority or Other||Odds Ratio (OR)|0.569||||0.165|2-Sided|95.0|0.257|1.262|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, diabetes duration and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753849|NCT00286455|3223356|Superiority or Other||Mean Difference (Final Values)|-27.8|||<|0.001|2-Sided|95.0|-40.4|-15.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753850|NCT00286455|3223356|Superiority or Other||Mean Difference (Final Values)|-21.6|||<|0.001|2-Sided|95.0|-34.1|-9.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753851|NCT00286455|3223357|Superiority or Other||Mean Difference (Final Values)|-24.3|||<|0.001|2-Sided|95.0|-35.7|-12.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753852|NCT00286455|3223357|Superiority or Other||Mean Difference (Final Values)|-19.3|||<|0.001|2-Sided|95.0|-30.6|-8.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753853|NCT00286455|3223358|Superiority or Other||Mean Difference (Final Values)|-23.4|||<|0.001|2-Sided|95.0|-34.6|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753854|NCT00286455|3223358|Superiority or Other||Mean Difference (Final Values)|-19.8|||<|0.001|2-Sided|95.0|-30.9|-8.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753855|NCT00286455|3223359|Superiority or Other||Mean Difference (Final Values)|-21.2|||<|0.001|2-Sided|95.0|-31.6|-10.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753856|NCT00286455|3223359|Superiority or Other||Mean Difference (Final Values)|-16.5|||<|0.002|2-Sided|95.0|-26.8|-6.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753857|NCT00286455|3223360|Superiority or Other||Mean Difference (Final Values)|-22.3|||<|0.001|2-Sided|95.0|-32.4|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753858|NCT00286455|3223360|Superiority or Other||Mean Difference (Final Values)|-16.7|||<|0.001|2-Sided|95.0|-26.8|-6.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753859|NCT00286455|3223361|Superiority or Other||Mean Difference (Final Values)|-24.4|||<|0.001|2-Sided|95.0|-33.2|-15.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753860|NCT00286455|3223361|Superiority or Other||Mean Difference (Final Values)|-18.4|||<|0.001|2-Sided|95.0|-27.1|-9.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753861|NCT00286455|3223362|Superiority or Other||Mean Difference (Final Values)|-21.4|||<|0.001|2-Sided|95.0|-29.7|-13.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753862|NCT00286455|3223362|Superiority or Other||Mean Difference (Final Values)|-18.4|||<|0.001|2-Sided|95.0|-26.7|-10.1||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753863|NCT00286455|3223363|Superiority or Other||Mean Difference (Final Values)|-18.7|||<|0.001|2-Sided|95.0|-27.0|-10.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753864|NCT00286455|3223363|Superiority or Other||Mean Difference (Final Values)|-13.2|||<|0.002|2-Sided|95.0|-21.5|-5.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753865|NCT00286455|3223364|Superiority or Other||Mean Difference (Final Values)|-0.48|||<|0.001|2-Sided|95.0|-0.7|-0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753866|NCT00286455|3223364|Superiority or Other||Mean Difference (Final Values)|-0.45|||<|0.001|2-Sided|95.0|-0.67|-0.24||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753867|NCT00286455|3223365|Superiority or Other||Mean Difference (Final Values)|-0.54|||<|0.001|2-Sided|95.0|-0.74|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753868|NCT00286455|3223365|Superiority or Other||Mean Difference (Final Values)|-0.47|||<|0.001|2-Sided|95.0|-0.68|-0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753869|NCT00286455|3223366|Superiority or Other||Mean Difference (Final Values)|-0.54|||<|0.001|2-Sided|95.0|-0.73|-0.35||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753870|NCT00286455|3223366|Superiority or Other||Mean Difference (Final Values)|-0.44|||<|0.001|2-Sided|95.0|-0.63|-0.25||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753871|NCT00286455|3223367|Superiority or Other||Mean Difference (Final Values)|-0.51|||<|0.001|2-Sided|95.0|-0.68|-0.33||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1754130|NCT00283842|3223575|Superiority or Other|||||||0.001|||||||Hochberg|||Statistical analysis provided for 200mg.|
1753872|NCT00286455|3223367|Superiority or Other||Mean Difference (Final Values)|-0.4|||<|0.001|2-Sided|95.0|-0.57|-0.23||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753873|NCT00286455|3223368|Superiority or Other||Mean Difference (Final Values)|-0.34|||<|0.001|2-Sided|95.0|-0.46|-0.21||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753874|NCT00286455|3223368|Superiority or Other||Mean Difference (Final Values)|-0.26|||<|0.001|2-Sided|95.0|-0.39|-0.14||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint parameter as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753875|NCT00286455|3223369|Superiority or Other||Mean Difference (Final Values)|-0.57|||<|0.001|2-Sided|95.0|-0.8|-0.35|||ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided >0.05 significance level and >=80% of subjects meeting per protocol criteria.|
1753876|NCT00286455|3223369|Superiority or Other||Mean Difference (Final Values)|-0.54|||<|0.001|2-Sided|95.0|-0.76|-0.31||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Treatment and geographic region as class variables; diabetes duration and baseline value for the endpoint (HbA1c) as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=325 subjects had 95% power to detect a treatment difference as small as 0.5% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided >0.05 significance level and >=80% of subjects meeting per protocol criteria.|
1753877|NCT00286442|3223370|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.407|2-Sided|95.0|-0.94|0.38||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753878|NCT00286442|3223370|Superiority or Other||Mean Difference (Final Values)|0.0||||0.996|2-Sided|95.0|-0.66|0.66||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753879|NCT00286442|3223371|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.559|2-Sided|95.0|-0.79|0.43||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753880|NCT00286442|3223371|Superiority or Other||Mean Difference (Final Values)|0.03||||0.93|2-Sided|95.0|-0.58|0.63||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753881|NCT00286442|3223372|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.788|2-Sided|95.0|-0.63|0.47||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753882|NCT00286442|3223372|Superiority or Other||Mean Difference (Final Values)|0.29||||0.305|2-Sided|95.0|-0.26|0.83||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753883|NCT00286442|3223373|Superiority or Other||Mean Difference (Final Values)|-0.41||||0.075|2-Sided|95.0|-0.86|0.04||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753884|NCT00286442|3223373|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.439|2-Sided|95.0|-0.63|0.27||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline weight as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753885|NCT00286442|3223374|Superiority or Other||Odds Ratio (OR)|0.959||||0.956|2-Sided|95.0|0.218|4.223||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1754088|NCT00285584|3223491|Superiority or Other||Risk Ratio (RR)|3.15||||0.3|2-Sided|95.0|0.4|27.8|||Fisher Exact|||Comparison of cumulative incidence proportions|
1753887|NCT00286442|3223375|Superiority or Other||Odds Ratio (OR)|2.958||||0.034|2-Sided|95.0|1.087|8.046||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1753888|NCT00286442|3223375|Superiority or Other||Odds Ratio (OR)|2.449||||0.085|2-Sided|95.0|0.883|6.797||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1753889|NCT00286442|3223376|Superiority or Other||Odds Ratio (OR)|5.793|||<|0.001|2-Sided|95.0|2.645|12.684||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1753890|NCT00286442|3223376|Superiority or Other||Odds Ratio (OR)|5.601|||<|0.001|2-Sided|95.0|2.554|12.282||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1753891|NCT00286442|3223377|Superiority or Other||Odds Ratio (OR)|4.314|||<|0.001|2-Sided|95.0|2.545|7.312||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1753892|NCT00286442|3223377|Superiority or Other||Odds Ratio (OR)|4.103|||<|0.001|2-Sided|95.0|2.428|6.934||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1753893|NCT00286442|3223378|Superiority or Other||Odds Ratio (OR)|3.293|||<|0.001|2-Sided|95.0|1.814|5.979|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1753894|NCT00286442|3223378|Superiority or Other||Odds Ratio (OR)|4.238|||<|0.001|2-Sided|95.0|2.327|7.717||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1753895|NCT00286442|3223379|Superiority or Other||Odds Ratio (OR)|4.451|||<|0.001|2-Sided|95.0|2.388|8.296||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1753896|NCT00286442|3223379|Superiority or Other||Odds Ratio (OR)|6.092|||<|0.001|2-Sided|95.0|3.271|11.345||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1753897|NCT00286442|3223380|Superiority or Other||Odds Ratio (OR)|5.322||||0.002|2-Sided|95.0|1.82|15.564||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1753898|NCT00286442|3223380|Superiority or Other||Odds Ratio (OR)|6.15|||<|0.001|2-Sided|95.0|2.117|17.864||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.||
1753899|NCT00286442|3223381|Superiority or Other||Mean Difference (Final Values)|0.263||||0.074|2-Sided|95.0|-0.025|0.55||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753900|NCT00286442|3223381|Superiority or Other||Mean Difference (Final Values)|0.394||||0.007|2-Sided|95.0|0.107|0.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753901|NCT00286442|3223382|Superiority or Other||Mean Difference (Final Values)|0.191||||0.177|2-Sided|95.0|-0.086|0.468||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753902|NCT00286442|3223382|Superiority or Other||Mean Difference (Final Values)|0.144||||0.305|2-Sided|95.0|-0.132|0.42||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753903|NCT00286442|3223383|Superiority or Other||Mean Difference (Final Values)|0.268||||0.089|2-Sided|95.0|-0.041|0.577||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753904|NCT00286442|3223383|Superiority or Other||Mean Difference (Final Values)|0.155||||0.321|2-Sided|95.0|-0.152|0.463||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753905|NCT00286442|3223384|Superiority or Other||Mean Difference (Final Values)|0.279||||0.083|2-Sided|95.0|-0.037|0.595||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753906|NCT00286442|3223384|Superiority or Other||Mean Difference (Final Values)|0.187||||0.243|2-Sided|95.0|-0.127|0.501||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753907|NCT00286442|3223385|Superiority or Other||Mean Difference (Final Values)|0.111||||0.467|2-Sided|95.0|-0.188|0.41||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753908|NCT00286442|3223385|Superiority or Other||Mean Difference (Final Values)|0.088||||0.563|2-Sided|95.0|-0.209|0.384||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753909|NCT00286442|3223386|Superiority or Other||Mean Difference (Final Values)|0.304||||0.051|2-Sided|95.0|-0.002|0.611||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753910|NCT00286442|3223386|Superiority or Other||Mean Difference (Final Values)|0.336||||0.031|2-Sided|95.0|0.03|0.642||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline C-peptide as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753911|NCT00286442|3223387|Superiority or Other||Mean Difference (Final Values)|-0.004||||0.889|2-Sided|95.0|-0.057|0.05||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753912|NCT00286442|3223387|Superiority or Other||Mean Difference (Final Values)|-0.053||||0.048|2-Sided|95.0|-0.106|-0.001||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753913|NCT00286442|3223388|Superiority or Other||Mean Difference (Final Values)|-0.005||||0.86|2-Sided|95.0|-0.056|0.047||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753914|NCT00286442|3223388|Superiority or Other||Mean Difference (Final Values)|-0.046||||0.078|2-Sided|95.0|-0.097|0.005||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753915|NCT00286442|3223389|Superiority or Other||Mean Difference (Final Values)|-0.044||||0.003|2-Sided|95.0|-0.072|-0.015||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753916|NCT00286442|3223389|Superiority or Other||Mean Difference (Final Values)|-0.052|||<|0.001|2-Sided|95.0|-0.08|-0.024||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753917|NCT00286442|3223390|Superiority or Other||Mean Difference (Final Values)|-0.037||||0.011|2-Sided|95.0|-0.066|-0.008||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm||
1753918|NCT00286442|3223390|Superiority or Other||Mean Difference (Final Values)|-0.039||||0.007|2-Sided|95.0|-0.068|-0.011||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm||
1753919|NCT00286442|3223391|Superiority or Other||Mean Difference (Final Values)|-0.037||||0.004|2-Sided|95.0|-0.062|-0.012||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753920|NCT00286442|3223391|Superiority or Other||Mean Difference (Final Values)|-0.045|||<|0.001|2-Sided|95.0|-0.07|-0.021||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753921|NCT00286442|3223392|Superiority or Other||Mean Difference (Final Values)|-0.047|||<|0.001|2-Sided|95.0|-0.075|-0.019||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753922|NCT00286442|3223392|Superiority or Other||Mean Difference (Final Values)|-0.036|||<|0.011|2-Sided|95.0|-0.064|-0.009||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin/insulin ratio as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753923|NCT00286442|3223393|Superiority or Other||Mean Difference (Final Values)|2.22||||0.067|2-Sided|95.0|-0.15|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753924|NCT00286442|3223393|Superiority or Other||Mean Difference (Final Values)|2.87||||0.018|2-Sided|95.0|0.5|5.23||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753925|NCT00286442|3223394|Superiority or Other||Mean Difference (Final Values)|1.07||||0.425|2-Sided|95.0|-1.56|3.69||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753926|NCT00286442|3223394|Superiority or Other||Mean Difference (Final Values)|1.12||||0.398|2-Sided|95.0|-1.48|3.72||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753927|NCT00286442|3223395|Superiority or Other||Mean Difference (Final Values)|0.89||||0.601|2-Sided|95.0|-2.44|4.21||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753928|NCT00286442|3223395|Superiority or Other||Mean Difference (Final Values)|0.63||||0.708|2-Sided|95.0|-2.67|3.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753929|NCT00286442|3223396|Superiority or Other||Mean Difference (Final Values)|-1.45||||0.578|2-Sided|95.0|-6.59|3.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753930|NCT00286442|3223396|Superiority or Other||Mean Difference (Final Values)|-0.32||||0.901|2-Sided|95.0|-5.42|4.77||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753931|NCT00286442|3223397|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.316|2-Sided|95.0|-7.4|2.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753932|NCT00286442|3223397|Superiority or Other||Mean Difference (Final Values)|-0.17||||0.944|2-Sided|95.0|-5.02|4.68||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753933|NCT00286442|3223398|Superiority or Other||Mean Difference (Final Values)|1.6||||0.18|2-Sided|95.0|-0.74|3.93||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753934|NCT00286442|3223398|Superiority or Other||Mean Difference (Final Values)|2.19||||0.066|2-Sided|95.0|-0.15|4.52||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline insulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753935|NCT00286442|3223399|Superiority or Other||Mean Difference (Final Values)|0.601||||1.6|2-Sided|95.0|-4.5|7.8||No multiplicity adjustments|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753936|NCT00286442|3223399|Superiority or Other||Mean Difference (Final Values)|1.1||||0.727|2-Sided|95.0|-5.0|7.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753937|NCT00286442|3223400|Superiority or Other||Mean Difference (Final Values)|0.9||||0.746|2-Sided|95.0|-4.6|6.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753938|NCT00286442|3223400|Superiority or Other||Mean Difference (Final Values)|-2.2||||0.427|2-Sided|95.0|-7.8|3.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753939|NCT00286442|3223401|Superiority or Other||Mean Difference (Final Values)|-2.2||||0.432|2-Sided|95.0|-7.7|3.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753940|NCT00286442|3223401|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.748|2-Sided|95.0|-6.3|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753941|NCT00286442|3223402|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.645|2-Sided|95.0|-7.4|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753942|NCT00286442|3223402|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.655|2-Sided|95.0|-7.4|4.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753943|NCT00286442|3223403|Superiority or Other||Mean Difference (Final Values)|-4.6||||0.046|2-Sided|95.0|-9.1|-0.1||No multiplicity adjustments.|ANCOVA||Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753944|NCT00286442|3223403|Superiority or Other||Mean Difference (Final Values)|-2.5||||0.274|2-Sided|95.0|-6.9|2.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753945|NCT00286442|3223404|Superiority or Other||Mean Difference (Final Values)|-4.5||||0.136|2-Sided|95.0|-10.5|1.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753946|NCT00286442|3223404|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.634|2-Sided|95.0|-7.4|4.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline proinsulin as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753947|NCT00286442|3223405|Superiority or Other||Odds Ratio (OR)|0.236|||<|0.001|2-Sided|95.0|0.109|0.51|||Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753948|NCT00286442|3223405|Superiority or Other||Odds Ratio (OR)|0.302|||<|0.002|2-Sided|95.0|0.143|0.635||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753949|NCT00286442|3223406|Superiority or Other||Odds Ratio (OR)|0.405||||0.002|2-Sided|95.0|0.231|0.708||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753950|NCT00286442|3223406|Superiority or Other||Odds Ratio (OR)|0.372|||<|0.001|2-Sided|95.0|0.213|0.65||no multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin dose and baseline HbA1c.|Odd's Ratio (OR) is alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.||
1753951|NCT00286442|3223407|Superiority or Other||Mean Difference (Final Values)|-17.4|||<|0.001|2-Sided|95.0|-25.9|-8.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753952|NCT00286442|3223407|Superiority or Other||Mean Difference (Final Values)|-18.7|||<|0.001|2-Sided|95.0|-27.3|-10.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753953|NCT00286442|3223408|Superiority or Other||Mean Difference (Final Values)|-15.5|||<|0.001|2-Sided|95.0|-24.2|-6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753954|NCT00286442|3223408|Superiority or Other||Mean Difference (Final Values)|-18.1|||<|0.001|2-Sided|95.0|-26.7|-9.4||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753955|NCT00286442|3223409|Superiority or Other||Mean Difference (Final Values)|-16.7|||<|0.001|2-Sided|95.0|-25.0|-8.3||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1754089|NCT00285584|3223492|Superiority or Other||Median Difference (Net)|0.5||||0.3|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank test|
1754090|NCT00285584|3223493|Superiority or Other||Median Difference (Final Values)|1.5||||0.9|||||||Wilcoxon (Mann-Whitney)||||
1753956|NCT00286442|3223409|Superiority or Other||Mean Difference (Final Values)|-19.1|||<|0.001|2-Sided|95.0|-27.4|-10.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753957|NCT00286442|3223410|Superiority or Other||Mean Difference (Final Values)|-17.0|||<|0.001|2-Sided|95.0|-25.4|-8.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753958|NCT00286442|3223410|Superiority or Other||Mean Difference (Final Values)|-17.2|||<|0.001|2-Sided|95.0|-25.6|-8.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753959|NCT00286442|3223411|Superiority or Other||Mean Difference (Final Values)|-17.6|||<|0.001|2-Sided|95.0|-25.6|-9.7||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753960|NCT00286442|3223411|Superiority or Other||Mean Difference (Final Values)|-20.1|||<|0.001|2-Sided|95.0|-28.0|-12.2||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753961|NCT00286442|3223412|Superiority or Other||Mean Difference (Final Values)|-17.5|||<|0.001|2-Sided|95.0|-24.3|-10.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753962|NCT00286442|3223412|Superiority or Other||Mean Difference (Final Values)|-17.8|||<|0.001|2-Sided|95.0|-24.6|-11.0||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753963|NCT00286442|3223413|Superiority or Other||Mean Difference (Final Values)|-16.8|||<|0.001|2-Sided|95.0|-24.1|-9.6||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753964|NCT00286442|3223413|Superiority or Other||Mean Difference (Final Values)|-16.7|||<|0.001|2-Sided|95.0|-23.9|-9.5||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753965|NCT00286442|3223414|Superiority or Other||Mean Difference (Final Values)|-11.9|||<|0.001|2-Sided|95.0|-18.9|-4.9||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the metformin arm.||
1753966|NCT00286442|3223414|Superiority or Other||Mean Difference (Final Values)|-13.7|||<|0.001|2-Sided|95.0|-20.7|-6.8||No multiplicity adjustments.|ANCOVA|Treatment and geographic region as class variables; baseline metformin dose and baseline FPG as covariates. Missing data imputed with LOCF.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the metformin arm.||
1753967|NCT00286442|3223415|Superiority or Other||Mean Difference (Final Values)|-0.52|||<|0.001|2-Sided|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753968|NCT00286442|3223415|Superiority or Other||Mean Difference (Final Values)|-0.52|||<|0.001|2-Sided|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753969|NCT00286442|3223416|Superiority or Other||Mean Difference (Final Values)|-0.51|||<|0.001|2-Sided|95.0|-0.69|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753970|NCT00286442|3223416|Superiority or Other||Mean Difference (Final Values)|-0.53|||<|0.001|2-Sided|95.0|-0.7|-0.36||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753971|NCT00286442|3223417|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.001|2-Sided|95.0|-0.66|-0.34||No multiplicity adjustments|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1754131|NCT00283842|3223575|Superiority or Other|||||||0.084|||||||Hochberg|||Statistical analysis provided for 100mg.|
1753972|NCT00286442|3223417|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.001|2-Sided|95.0|-0.66|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753973|NCT00286442|3223418|Superiority or Other||Mean Difference (Final Values)|-0.38|||<|0.001|2-Sided|95.0|-0.52|-0.24||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753974|NCT00286442|3223418|Superiority or Other||Mean Difference (Final Values)|-0.38|||<|0.001|2-Sided|95.0|-0.52|-0.24||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753975|NCT00286442|3223419|Superiority or Other||Mean Difference (Final Values)|-0.3|||<|0.001|2-Sided|95.0|-0.4|-0.19||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753976|NCT00286442|3223419|Superiority or Other||Mean Difference (Final Values)|-0.26|||<|0.001|2-Sided|95.0|-0.37|-0.16||No multiplicity adjustments.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.||
1753977|NCT00286442|3223420|Superiority or Other||Mean Difference (Final Values)|-0.48|||<|0.001|2-Sided|95.0|-0.67|-0.3||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA on change from baseline with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at week 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=500 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming SD=0.8%, 2-sided test at 0.05 significance level and >=80% of participants meeting per protocol criteria.|
1753978|NCT00286442|3223420|Superiority or Other||Mean Difference (Final Values)|-0.5|||<|0.001|2-Sided|95.0|-0.68|-0.32||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|Analysis of covariance (ANCOVA) with treatment and geographic region as class variables and baseline metformin dose and baseline HbA1c as covariates.|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|Null Hypothesis: No difference between treatment and placebo arms in change from baseline in glycosylated hemoglobin at wk 26. Sample size calculated based on normally distributed means. For comparison of either dose vs. placebo (2-sample t-test), study sample size >=500 participants had 95% power to detect a treatment difference as small as 0.4% in the supportive per protocol analysis set assuming SD=0.8%, 2-sided >0.05 significance level and >=80% of participants meeting per protocol criteria.|
1753979|NCT00286429|3223421|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.948|2-Sided|95.0|-0.7|0.65||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1753980|NCT00286429|3223421|Superiority or Other||Mean Difference (Final Values)|0.05||||0.874|2-Sided|95.0|-0.62|0.72||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1753981|NCT00286429|3223422|Superiority or Other||Mean Difference (Final Values)|-0.27||||0.404|2-Sided|95.0|-0.91|0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754091|NCT00285012|3223507|Superiority or Other|||||||0.023|||||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Total Score|
1754092|NCT00285012|3223507|Superiority or Other|||||||0.078|||||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Total Score|
1757602|NCT00227903|3228417|Superiority or Other (legacy)|||||||0.1|||||||Mixed Models Analysis||||
1753982|NCT00286429|3223422|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.586|2-Sided|95.0|-0.81|0.46||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1753983|NCT00286429|3223423|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.556|2-Sided|95.0|-0.8|0.43||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1753984|NCT00286429|3223423|Superiority or Other||Mean Difference (Final Values)|-0.06||||0.841|2-Sided|95.0|-0.67|0.55||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1753985|NCT00286429|3223424|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.439|2-Sided|95.0|-0.74|0.32||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1753986|NCT00286429|3223424|Superiority or Other||Mean Difference (Final Values)|-0.28||||0.291|2-Sided|95.0|-0.81|0.24||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and weight).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in body weight at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1753987|NCT00286429|3223426|Superiority or Other||Odds Ratio (OR)|4.58||||0.002|2-Sided|95.0|1.74|12.052||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.|
1753988|NCT00286429|3223426|Superiority or Other||Odds Ratio (OR)|4.55||||0.002|2-Sided|95.0|1.732|11.953||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.|
1753989|NCT00286429|3223427|Superiority or Other||Odds Ratio (OR)|3.989|||<|0.001|2-Sided|95.0|2.083|7.64||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.|
1753990|NCT00286429|3223427|Superiority or Other||Odds Ratio (OR)|3.163|||<|0.001|2-Sided|95.0|1.651|6.06||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥1.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.|
1753991|NCT00286429|3223428|Superiority or Other||Odds Ratio (OR)|2.819|||<|0.001|2-Sided|95.0|1.653|4.808||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥0.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.|
1757650|NCT00225017|3228597|Superiority or Other||||||<|0.009|||||||Wilcoxon (Mann-Whitney)||||
1753992|NCT00286429|3223428|Superiority or Other||Odds Ratio (OR)|2.674|||<|0.001|2-Sided|95.0|1.579|4.53||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c decrease from baseline ≥0.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.|
1753993|NCT00286429|3223429|Superiority or Other||Odds Ratio (OR)|9.784|||<|0.001|2-Sided|95.0|3.54|27.039||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c|Odds Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.|
1753994|NCT00286429|3223429|Superiority or Other||Odds Ratio (OR)|5.777|||<|0.001|2-Sided|95.0|2.047|16.305||No multiplicity adjustments.|ANCOVA|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c|Odds Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.5%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.|
1753995|NCT00286429|3223430|Superiority or Other||Odds Ratio (OR)|11.255||||0.023|2-Sided|95.0|1.401|90.379||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo was evaluated inferentially with a Wald test at the 0.05 significance level|
1753996|NCT00286429|3223430|Superiority or Other||Odds Ratio (OR)|12.65||||0.016|2-Sided|95.0|1.589|100.682||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) compares alogliptin arm versus placebo. OR >1.0 indicates higher incidence of response compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in incidence of HbA1c ≤7.0%. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.|
1753997|NCT00286429|3223432|Superiority or Other||Mean Difference (Final Values)|0.125||||0.459|2-Sided|95.0|-0.207|0.457||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1753998|NCT00286429|3223432|Superiority or Other||Mean Difference (Final Values)|0.282||||0.091|2-Sided|95.0|-0.045|0.61||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1753999|NCT00286429|3223433|Superiority or Other||Mean Difference (Final Values)|0.042||||0.839|2-Sided|95.0|-0.366|0.45||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754000|NCT00286429|3223433|Superiority or Other||Mean Difference (Final Values)|0.079||||0.7|2-Sided|95.0|-0.324|0.482||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754001|NCT00286429|3223434|Superiority or Other||Mean Difference (Final Values)|0.156||||0.474|2-Sided|95.0|-0.272|0.583||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754132|NCT00283842|3223575|Superiority or Other|||||||0.084|||||||Hochberg|||Statistical analysis provided for 50mg.|
1754002|NCT00286429|3223434|Superiority or Other||Mean Difference (Final Values)|0.078||||0.716|2-Sided|95.0|-0.344|0.5||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754003|NCT00286429|3223435|Superiority or Other||Mean Difference (Final Values)|0.183||||0.407|2-Sided|95.0|-0.251|0.616||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754004|NCT00286429|3223435|Superiority or Other||Mean Difference (Final Values)|0.126||||0.562|2-Sided|95.0|-0.302|0.554||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754005|NCT00286429|3223436|Superiority or Other||Mean Difference (Final Values)|0.372||||0.032|2-Sided|95.0|0.032|0.712||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754006|NCT00286429|3223436|Superiority or Other||Mean Difference (Final Values)|0.202||||0.236|2-Sided|95.0|-0.132|0.536||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754007|NCT00286429|3223437|Superiority or Other||Mean Difference (Final Values)|0.477||||0.001|2-Sided|95.0|0.188|0.765||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-peptide at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754008|NCT00286429|3223437|Superiority or Other||Mean Difference (Final Values)|0.156||||0.286|2-Sided|95.0|-0.131|0.443||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and C-peptide).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in C-Peptide at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754009|NCT00286429|3223438|Superiority or Other||Odds Ratio (OR)|0.339|||<|0.001|2-Sided|95.0|0.189|0.608||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants requiring rescue. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.|
1754010|NCT00286429|3223438|Superiority or Other||Odds Ratio (OR)|0.35|||<|0.001|2-Sided|95.0|0.198|0.619||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo arm. OR <1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants requiring rescue. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.|
1754011|NCT00286429|3223439|Superiority or Other||Odds Ratio (OR)|0.364||||0.002|2-Sided|95.0|0.191|0.695||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants with marked hyperglycemia. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.|
1758384|NCT00205777|3229639|Superiority or Other|||||||0.088|||||||ANOVA||||
1754012|NCT00286429|3223439|Superiority or Other||Odds Ratio (OR)|0.551||||0.075|2-Sided|95.0|0.286|1.063||No multiplicity adjustments.|Regression, Logistic|Logistic regression model includes effects for treatment, geographic region, baseline metformin regimen, baseline insulin dose, and baseline HbA1c.|Odds Ratio (OR) is alogliptin arm versus placebo. OR <1.0 indicates lower incidence compared to placebo.|The null hypothesis that there is no treatment effect between alogliptin and placebo arms in number of participants with marked hyperglycemia. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a Wald test at the 0.05 significance level.|
1754013|NCT00286429|3223440|Superiority or Other||Mean Difference (Final Values)|-17.6||||0.03|2-Sided|95.0|-33.4|-1.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754014|NCT00286429|3223440|Superiority or Other||Mean Difference (Final Values)|-3.5||||0.662|2-Sided|95.0|-19.2|12.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 26. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754015|NCT00286429|3223441|Superiority or Other||Mean Difference (Final Values)|-19.9||||0.01|2-Sided|95.0|-35.1|-4.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754016|NCT00286429|3223441|Superiority or Other||Mean Difference (Final Values)|-12.7||||0.097|2-Sided|95.0|-27.8|2.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754017|NCT00286429|3223442|Superiority or Other||Mean Difference (Final Values)|-10.9||||0.154|2-Sided|95.0|-25.8|4.1||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 16. The treatment effect was be evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754018|NCT00286429|3223442|Superiority or Other||Mean Difference (Final Values)|-9.9||||0.19|2-Sided|95.0|-24.7|4.9||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754019|NCT00286429|3223443|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.853|2-Sided|95.0|-16.7|13.8||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754020|NCT00286429|3223443|Superiority or Other||Mean Difference (Final Values)|-3.8||||0.624|2-Sided|95.0|-18.9|11.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754021|NCT00286429|3223444|Superiority or Other||Mean Difference (Final Values)|-19.5||||0.011|2-Sided|95.0|-34.5|-4.5||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754022|NCT00286429|3223444|Superiority or Other||Mean Difference (Final Values)|-18.9||||0.013|2-Sided|95.0|-33.7|-4.0||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 8. The treatment effect was be evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754023|NCT00286429|3223445|Superiority or Other||Mean Difference (Final Values)|-17.4||||0.02|2-Sided|95.0|-32.1|-2.8||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754024|NCT00286429|3223445|Superiority or Other||Mean Difference (Final Values)|-10.3||||0.16|2-Sided|95.0|-24.7|4.1||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754025|NCT00286429|3223446|Superiority or Other||Mean Difference (Final Values)|-12.4||||0.084|2-Sided|95.0|-26.4|1.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 2. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754026|NCT00286429|3223446|Superiority or Other||Mean Difference (Final Values)|-4.1||||0.563|2-Sided|95.0|-17.9|9.7||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 2. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754027|NCT00286429|3223447|Superiority or Other||Mean Difference (Final Values)|-16.1||||0.034|2-Sided|95.0|-31.1|-1.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 1. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754028|NCT00286429|3223447|Superiority or Other||Mean Difference (Final Values)|-11.3||||0.128|2-Sided|95.0|-25.9|3.3||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and FPG).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in FPG at Week 1. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754029|NCT00286429|3223448|Superiority or Other||Mean Difference (Final Values)|-0.57|||<|0.001|2-Sided|95.0|-0.79|-0.35||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754030|NCT00286429|3223448|Superiority or Other||Mean Difference (Final Values)|-0.59|||<|0.001|2-Sided|95.0|-0.8|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 20. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754031|NCT00286429|3223449|Superiority or Other||Mean Difference (Final Values)|-0.54|||<|0.001|2-Sided|95.0|-0.75|-0.33||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754032|NCT00286429|3223449|Superiority or Other||Mean Difference (Final Values)|-0.58|||<|0.001|2-Sided|95.0|-0.79|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 16. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754033|NCT00286429|3223450|Superiority or Other||Mean Difference (Final Values)|-0.54|||<|0.001|2-Sided|95.0|-0.75|-0.34||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754034|NCT00286429|3223450|Superiority or Other||Mean Difference (Final Values)|-0.57|||<|0.001|2-Sided|95.0|-0.77|-0.37||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 12. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754035|NCT00286429|3223451|Superiority or Other||Mean Difference (Final Values)|-0.56|||<|0.001|2-Sided|95.0|-0.73|-0.39||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754036|NCT00286429|3223451|Superiority or Other||Mean Difference (Final Values)|-0.48|||<|0.001|2-Sided|95.0|-0.65|-0.31||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 8. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754037|NCT00286429|3223452|Superiority or Other||Mean Difference (Final Values)|-0.32|||<|0.001|2-Sided|95.0|-0.45|-0.2||No multiplicity adjustments.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754038|NCT00286429|3223452|Superiority or Other||Mean Difference (Final Values)|-0.21|||<|0.001|2-Sided|95.0|-0.34|-0.09||No multiplicity adjustments|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 4. The treatment effect was evaluated as a contrast of each active dose versus placebo and was evaluated inferentially with a 2-sided t test at the 0.05 significance level.|
1754039|NCT00286429|3223453|Superiority or Other||Mean Difference (Final Values)|-0.59|||<|0.001|2-Sided|95.0|-0.8|-0.37||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 26. For comparison of either alogliptin dose vs. placebo (2-sample t test), study sample size >=390 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming a standard deviation of 0.8%, a 2-sided test at 0.05 significance level and >=80% of subjects meeting the per protocol criteria.|
1754093|NCT00285012|3223507|Superiority or Other|||||||0.033|||||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Total Score|
1754094|NCT00285012|3223507|Superiority or Other|||||||0.016|||||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 52 Respiratory Symptoms|
1754095|NCT00285012|3223507|Superiority or Other|||||||0.081|||||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Respiratory Symptoms|
1754096|NCT00285012|3223507|Superiority or Other|||||||0.002|||||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Respiratory Symptoms|
1754134|NCT00283712|3223594|Superiority or Other||Odds Ratio (OR)|0.43||||0.65|2-Sided|90.0|0.06|2.79|||Fisher Exact||||
1754040|NCT00286429|3223453|Superiority or Other||Mean Difference (Final Values)|-0.51|||<|0.001|2-Sided|95.0|-0.72|-0.3||A step-down strategy was used for the primary analysis. First, the 25mg dose was compared to placebo at the 2-sided 0.05 significance level. The 12.5 mg dose was compared to placebo only if the comparison of the 25mg dose to placebo was significant.|ANCOVA|ANCOVA included treatment, geographic region, and baseline metformin regimen as class variables, and baseline covariates (insulin dose and HbA1c).|Negative mean treatment difference indicates larger decrease from baseline (more negative change from baseline) in the alogliptin arm compared to the placebo arm.|The null hypothesis that there is no difference between alogliptin and placebo arms in change from baseline in HbA1c at Week 26. For comparison of either alogliptin dose vs. placebo (2-sample t test), study sample size >=390 participants had 95% power to detect a treatment difference as small as 0.4% in the per protocol analysis set assuming a standard deviation of 0.8%, a 2-sided test at 0.05 significance level and >=80% of subjects meeting the per protocol criteria.|
1754041|NCT00286325|3223454|Superiority or Other||||||=|0|||||||Wilcoxon (Mann-Whitney)|||Comparison of B cell number at week 0 to b cell number in participants at week 24|
1754042|NCT00286325|3223455|Superiority or Other||||||=|0|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon comparing week zero antibody value in units to week 24 antibody value in units|
1754043|NCT00286156|3223463|Superiority or Other||||||<|0.01||||||Pairwise comparisons adjusted for multiple testing (Tukey)|ANOVA|||Null hypothesis: no difference between groups in iGFR|
1754044|NCT00286091|3223464|Superiority or Other||Hazard Ratio (HR)|1.01||||0.9125|2-Sided|95.0|0.85|1.2|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio < 1 favors denosumab.||
1754045|NCT00286091|3223465|Superiority or Other||Hazard Ratio (HR)|0.84||||0.0317|2-Sided|95.0|0.71|0.98|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio < 1 favors denosumab.||
1754046|NCT00286091|3223466|Superiority or Other||Hazard Ratio (HR)|0.85||||0.0284|2-Sided|95.0|0.73|0.98|||Wald test||Based on the Cox proportional hazards model stratified by PSA ≥ 8.0 ng/mL, PSA doubling time ≤ 10 months and previous or current chemotherapy for prostate cancer. A hazard ratio < 1 favors denosumab.|Primary and secondary endpoint analyses were conducted hierarchically. To preserve an overall type I error rate of 0.05, a 0.0488 2-sided test of bone metastasis-free survival was performed. If superiority of denosumab over placebo was established, time to first bone metastasis was tested with a 2-sided significance level of 0.050. If superiority of denosumab over placebo was also established, overall survival time was tested at a 2-sided significance level of 0.050.|
1754047|NCT00285779|3223477|Other|||||||0.026|||||||Paired t test|||Week 24 versus baseline|
1754048|NCT00285779|3223477|Other|||||||0.015|||||||Paired t test|||Week 24 versus baseline|
1754049|NCT00285779|3223477|Other|||||||0.069|||||||Paired t test|||Week 12 versus baseline|
1754050|NCT00285779|3223477|Other|||||||0.033|||||||Paired t test|||Week 12 versus baseline|
1754051|NCT00285779|3223478|Other|||||||0.86|||||||Paired t test|||Week 24 versus baseline|
1754052|NCT00285779|3223478|Other|||||||0.087|||||||Paired t test|||Week 24 versus baseline|
1754053|NCT00285779|3223478|Other|||||||0.47|||||||Paired t test|||Week 24 versus baseline|
1754054|NCT00285779|3223478|Other|||||||0.51|||||||Paired t test|||Week 12 versus baseline|
1754055|NCT00285779|3223479|Other|||||||0.13|||||||Paired t test|||Week 24 versus baseline|
1754056|NCT00285779|3223479|Other|||||||0.18|||||||Paired t test|||Week 24 versus baseline|
1754057|NCT00285779|3223479|Other|||||||0.55|||||||Paired t test|||Week 12 versus baseline|
1754058|NCT00285779|3223479|Other|||||||0.26|||||||Paired t test|||Week 12 versus baseline|
1754059|NCT00285779|3223480|Other|||||||0.19|||||||Wilcoxon Paired|||Week 24 versus baseline|
1754060|NCT00285779|3223480|Other|||||||0.039|||||||Wilcoxon Paired|||Week 24 versus baseline|
1754061|NCT00285779|3223480|Other|||||||0.094|||||||Wilcoxon Paired|||Week 12 versus baseline|
1754062|NCT00285779|3223480|Other|||||||0.031|||||||Wilcoxon Paired|||Week 12 versus baseline|
1754063|NCT00285779|3223481|Other|||||||0.5|||||||Wilcoxon Paired|||Week 24 versus baseline|
1754064|NCT00285779|3223481|Other|||||||0.38|||||||Wilcoxon Paired|||Week 24 versus baseline|
1754065|NCT00285779|3223481|Other|||||||0.38|||||||Wilcoxon Paired|||Week 12 versus baseline|
1754066|NCT00285779|3223481|Other|||||||0.63|||||||Wilcoxon Paired|||Week 12 versus baseline|
1754067|NCT00285779|3223482|Other|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline|
1754068|NCT00285779|3223482|Other|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline|
1754069|NCT00285779|3223482|Other|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline|
1754070|NCT00285779|3223482|Other|||||||0.094|||||||Wilcoxon Paired|||Week 12 versus baseline|
1754071|NCT00285779|3223483|Other|||||||0.32|||||||Wilcoxon Paired|||Week 24 versus baseline|
1754072|NCT00285779|3223483|Other|||||||0.031|||||||Wilcoxon Paired|||Week 24 versus baseline|
1754073|NCT00285779|3223483|Other|||||||0.25|||||||Wilcoxon Paired|||Week 12 versus baseline|
1754074|NCT00285779|3223483|Other|||||||0.063|||||||Wilcoxon Paired|||Week 12 versus baseline|
1754075|NCT00285779|3223484|Other||||||>|0.9999|||||||Wilcoxon Paired|||Week 24 versus baseline|
1754076|NCT00285779|3223484|Other||||||>|0.063|||||||Wilcoxon Paired|||Week 24 versus baseline|
1754077|NCT00285779|3223484|Other||||||>|0.9999|||||||Wilcoxon Paired|||Week 12 versus baseline|
1754078|NCT00285779|3223484|Other||||||>|0.25|||||||Wilcoxon Paired|||Week 12 versus baseline|
1754079|NCT00285779|3223485|Other||||||>|0.9999|||||||Wilcoxon Paired|||Week 24 versus baseline|
1754080|NCT00285779|3223485|Other||||||>|0.9999|||||||Wilcoxon Paired|||Week 12 versus baseline|
1754081|NCT00285779|3223486|Other|||||||0.22|||||||Wilcoxon Paired|||Week 24 versus baseline|
1754082|NCT00285779|3223486|Other|||||||0.13|||||||Wilcoxon Paired|||Week 24 versus baseline|
1754083|NCT00285779|3223486|Other|||||||0.34|||||||Wilcoxon Paired|||Week 12 versus baseline|
1754084|NCT00285779|3223486|Other|||||||0.031|||||||Wilcoxon Paired|||Week 12 versus baseline|
1754101|NCT00285012|3223507|Superiority or Other|||||||0.109|||||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 24 Mental State|
1754102|NCT00285012|3223507|Superiority or Other|||||||0.078|||||||ANCOVA|p-value obtained from ANCOVA model with fixed effect terms for center and treatment, and baseline score as a covariate.||Week 12 Mental State|
1754103|NCT00285012|3223508|Superiority or Other|||||||0.901|||||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 52 [LOCF] post-bronchodilator|
1754104|NCT00285012|3223508|Superiority or Other|||||||0.684|||||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 52 [LOCF] pre-bronchodilator|
1754105|NCT00285012|3223508|Superiority or Other|||||||0.007|||||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 12 [LOCF] post-bronchodilator|
1754106|NCT00285012|3223508|Superiority or Other|||||||0.14|||||||ANCOVA|p-value based on ANCOVA model with treatment and center as factors and baseline value as covariate.||Varenicline vs placebo at Week 12 [LOCF] pre-bronchodilator|
1754107|NCT00285012|3223509|Superiority or Other||Odds Ratio (OR)|2.45||||0.0002||95.0|1.52|3.95||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52|
1754108|NCT00285012|3223510|Superiority or Other||Odds Ratio (OR)|2.19||||0.0008||95.0|1.37|3.48||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52|
1754109|NCT00285012|3223510|Superiority or Other||Odds Ratio (OR)|2.85|||<|0.0001||95.0|1.79|4.54|||Regression, Logistic|p-value obtained from a logistic regression model including the main effects of treatment and pooled center|odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 24|
1754110|NCT00285012|3223510|Superiority or Other||Odds Ratio (OR)|6.99|||<|0.0001||95.0|4.39|11.11||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 12|
1754111|NCT00285012|3223511|Superiority or Other||Odds Ratio (OR)|3.92|||<|0.0001||95.0|2.18|7.07||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52|
1754112|NCT00285012|3223511|Superiority or Other||Odds Ratio (OR)|5.17|||<|0.0001||95.0|2.96|9.02||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 24|
1754113|NCT00285012|3223512|Superiority or Other||Odds Ratio (OR)|4.04|||<|0.0001||95.0|2.13|7.67||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline vs placebo at Week 52|
1754114|NCT00285012|3223512|Superiority or Other||Odds Ratio (OR)|4.88|||<|0.0001||95.0|2.75|8.65||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Varenicline versus (vs) placebo at Week 24|
1754115|NCT00285012|3223513|Superiority or Other||Odds Ratio (OR)|8.4|||<|0.0001||95.0|4.99|14.14||p-value obtained from a logistic regression model including the main effects of treatment and pooled center|Regression, Logistic||odds ratio obtained from a logistic regression model including the main effects of treatment and pooled center|Primary endpoint was based on a CO confirmed 4-week CQR (weeks 4 through 12 inclusive). Intent was to evaluate the alternative hypothesis that varenicline is superior to placebo for smoking cessation after 12 weeks of treatment in subjects with mild to moderate COPD.|
1754116|NCT00284856|3223518|Superiority or Other||Least Squares Mean Difference|-6.13||||||95.0|-12.46|0.2|||||Estimated value is difference in least squares mean (montelukast - fluticasone)||
1754117|NCT00284856|3223518|Superiority or Other||Least Squares Mean Difference|11.21||||||95.0|4.85|17.58|||||Estimated value is difference in least squares mean (fluticasone - placebo)||
1754118|NCT00284856|3223518|Superiority or Other||Least Squares Mean Difference|5.09||||||95.0|-1.27|11.45|||||Estimated value is difference in least squares mean (montelukast - placebo)||
1754119|NCT00284856|3223519|Superiority or Other||Least Squares Mean Difference|0.05||||||95.0|-0.05|0.15|||||Estimated value is difference in least squares mean (montelukast - fluticasone)||
1754120|NCT00284856|3223519|Superiority or Other||Least Squares Mean Difference|-0.2||||||95.0|-0.3|-0.1|||||Estimated value is difference in least squares mean (fluticasone - placebo)||
1754121|NCT00284856|3223519|Superiority or Other||Least Squares Mean Difference|-0.15||||||95.0|-0.25|-0.05|||||Estimated value is difference in least squares mean (montelukast - placebo)||
1754122|NCT00284856|3223520|Superiority or Other||Least Squares Mean Difference|-4.22||||||95.0|-9.83|1.38|||||Estimated value is difference in least squares mean (montelukast - fluticasone)||
1754123|NCT00284856|3223520|Superiority or Other||Least Squares Mean Difference|10.14||||||95.0|4.5|15.78|||||Estimated value is difference in least squares mean (fluticasone - placebo)||
1754124|NCT00284856|3223520|Superiority or Other||Least Squares Mean Difference|5.92||||||95.0|0.28|11.56|||||Estimated Value is difference in least squares mean (montelukast - placebo)||
1754125|NCT00283842|3223574|Superiority or Other|||||||0.375|||||||Hochberg|||Statistical analysis provided for 400mg.|
1754126|NCT00283842|3223574|Superiority or Other|||||||0.342|||||||Hochberg|||Statistical analysis provided for 200mg.|
1754127|NCT00283842|3223574|Superiority or Other|||||||0.342|||||||Hochberg|||Statistical analysis provided for 100mg.|
1754128|NCT00283842|3223574|Superiority or Other|||||||0.375|||||||Hochberg|||Statistical analysis provided for 50mg.|
1754136|NCT00283712|3223595|Superiority or Other||Odds Ratio (OR)|0.83||||1|2-Sided|90.0|0.02|38.35||All secondary analyses are considered supplemental supportive analyses|Fisher Exact|||The primary endpoint analysis was replicated using the per-protocol population.|
1754137|NCT00283712|3223595|Superiority or Other||Risk Difference (RD)|0.02||||1|2-Sided|90.0|-0.31|0.36||All secondary analyses are considered supplemental supportive analyses|Fisher Exact|||The primary endpoint analysis was replicated using the per-protocol population.|
1754138|NCT00283712|3223596|Superiority or Other||Risk Difference (RD)|-0.1|||||2-Sided|90.0|-0.26|0.06|||||||
1754139|NCT00283712|3223597|Superiority or Other||Odds Ratio (OR)|1.0||||1|2-Sided|90.0|0.02|42.67|||Fisher Exact||||
1754140|NCT00283712|3223597|Superiority or Other||Risk Difference (RD)|0.0||||1|2-Sided|90.0|-0.22|0.22|||Fisher Exact|||The study goals were to gather evidence of safety and possible efficacy of infliximab for treatment of pemphigus vulgaris (PV). The analyses focused on estimation rather than hypothesis testing; therefore, there was not sufficient power to detect plausible treatment differences unless they were very large. The sample size reflects a balance between the desire to meet study goals and to expose as few participants as possible until the safety of infliximab for treatment of PV has been clarified.|
1754141|NCT00283686|3223598|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.23||||0.0339|2-Sided|95.0|-0.44|-0.018|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site|||
1754142|NCT00283686|3223598|Superiority or Other (legacy)||Mean Difference (Final Values)|0.25||||0.0221|2-Sided|95.0|0.036|0.46|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site|||
1754143|NCT00283686|3223599|Superiority or Other (legacy)||Mean Difference (Final Values)|0.13||||0.14|2-Sided|95.0|-0.046|0.31|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site|||
1754144|NCT00283686|3223599|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.016||||0.87|2-Sided|95.0|-0.19|0.17|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site|||
1754145|NCT00283686|3223600|Superiority or Other (legacy)||Hazard Ratio (HR)|0.93||||0.59|2-Sided|95.0|0.7|1.22|||Regression, Cox|adjusting for age, sex, race, and clinical site|||
1754146|NCT00283686|3223600|Superiority or Other (legacy)||Hazard Ratio (HR)|0.71||||0.0228|2-Sided|95.0|0.53|0.95|||Regression, Cox|adjusting for age, sex, race, and clinical site|||
1754147|NCT00283686|3223601|Superiority or Other (legacy)||Mean Difference (Final Values)|0.98||||0.73|2-Sided|95.0|-4.54|6.5|||Mixed Models Analysis|adjusting for age, sex, race, baseline estimated GFR, and clinical site|difference in annual change mL/min/1.73 m^2 between low and standard blood pressure groups||
1754148|NCT00283686|3223601|Superiority or Other (legacy)||Mean Difference (Final Values)|2.97||||0.29|2-Sided|95.0|-2.55|8.5|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|difference in annual change in mL/min/1.73 m^2 for ACE+ARB compared to ACE alone||
1754149|NCT00283686|3223602|Superiority or Other (legacy)||Mean Difference (Net)|-0.6||||0.0002|2-Sided|95.0|-0.91|-0.29|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|comparing annual change in LVMI between Low Blood Pressure and Standard Blood Pressure groups||
1754150|NCT00283686|3223602|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.088||||0.58|2-Sided|95.0|-0.4|0.22|||Mixed Models Analysis|adjusted for age, sex, race, baseline estimated GFR, and clinical site|comparing the annual change over time between ACE/ARB and ACE alone||
1754151|NCT00283686|3223603|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.2||||0.19|2-Sided|95.0|-3.1|0.6|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site|||
1754152|NCT00283686|3223603|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.3||||0.18|2-Sided|95.0|-3.1|0.6|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site|||
1754153|NCT00283686|3223604|Superiority or Other (legacy)||Mean Difference (Final Values)|-6.1|||<|0.0001|2-Sided|95.0|-8.5|-3.4|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site|||
1754154|NCT00283686|3223604|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.7|||<|0.57|2-Sided|95.0|-3.3|1.9|||Mixed Models Analysis|adjusting for age, sex, race, and clinical site|||
1754155|NCT00283686|3223605|Superiority or Other (legacy)||Mean Difference (Final Values)|0.1||||0.55|2-Sided|95.0|-0.3|0.6||adjusted for age, sex, race, and clinical site|Mixed Models Analysis|Testing for differences between groups over time (differences in slopes over time)|||
1754156|NCT00283686|3223605|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.1||||0.52|2-Sided|95.0|-0.6|0.3||adjusting for age, sex, race, and clinical site|Mixed Models Analysis|Testing for differences in treatment over time (differences in slopes over time).|||
1754157|NCT00283686|3223606|Superiority or Other (legacy)||Mean Difference (Final Values)|-1.0||||0.006|2-Sided|95.0|-1.6|-0.2||adjusted for age, sex, race, baseline estimated GFR, and clinical site.|Mixed Models Analysis|Testing differences between blood pressure groups over time|||
1754158|NCT00283686|3223606|Superiority or Other (legacy)||Mean Difference (Final Values)|-0.2||||0.52|2-Sided|95.0|-0.8|5.0||adjusted for age, sex, race, baseline estimated GFR, and clinical site.|Mixed Models Analysis|Test for differences between treatment groups over time.|||
1754159|NCT00283439|3223612|Superiority or Other|||||||0.421|||||||Fisher Exact||||
1754160|NCT00283439|3223612|Superiority or Other|||||||0.588|||||||Fisher Exact||||
1754161|NCT00283439|3223612|Superiority or Other|||||||0.576|||||||Fisher Exact||||
1754162|NCT00283439|3223613|Superiority or Other|||||||0.881|||||||Satterhwaite t-test||||
1754163|NCT00283439|3223613|Superiority or Other|||||||0.3|||||||Satterhwaite t-test||||
1754164|NCT00283439|3223613|Superiority or Other|||||||0.091|||||||Satterhwaite t-test||||
1754165|NCT00283439|3223614|Superiority or Other|||||||0.603|||||||Fisher Exact||||
1754166|NCT00283439|3223614|Superiority or Other|||||||0.608|||||||Fisher Exact||||
1754167|NCT00283439|3223614|Superiority or Other|||||||0.294|||||||Fisher Exact||||
1754168|NCT00283439|3223615|Superiority or Other|||||||0.7133||||||One-sided test|Satterhwaite t-test||||
1754169|NCT00283439|3223615|Superiority or Other|||||||0.869||||||One-sided test|Satterhwaite t-test||||
1754170|NCT00283439|3223615|Superiority or Other|||||||0.9654||||||One-sided test|Satterhwaite t-test||||
1754171|NCT00283400|3223616|Superiority or Other||Odds Ratio (OR)|3.05|||<|0.05|2-Sided|95.0|0.65|14.1|||Mixed Models Analysis|Post-hoc comparison of outcomes in dosage tier 1 vs dosage tier 2.|||
1754172|NCT00283387|3223619|Superiority or Other|||||||0.007|||||||t-test, 2 sided||||
1754173|NCT00282984|3223645|Superiority or Other||Odds Ratio (OR)|3.85|||<|0.0001||95.0|2.58|5.75|||Regression, Logistic||||
1754174|NCT00282984|3223647|Superiority or Other||Odds Ratio (OR)|3.86|||<|0.0001||95.0|2.51|5.93|||Regression, Logistic||||
1754175|NCT00282984|3223648|Superiority or Other||Odds Ratio (OR)|2.05||||0.0001||95.0|1.41|2.97|||Regression, Logistic||||
1754176|NCT00282984|3223649|Superiority or Other||Odds Ratio (OR)|1.93||||0.0003||95.0|1.34|2.77|||Regression, Logistic|||52 Week analysis|
1754177|NCT00282984|3223650|Superiority or Other||Odds Ratio (OR)|2.93|||<|0.0001||95.0|2.03|4.23|||Regression, Logistic|||24 Week analysis|
1754178|NCT00282984|3223651|Superiority or Other||Odds Ratio (OR)|5.97|||<|0.0001||95.0|4.17|8.56|||Regression, Logistic|||Week 12 analysis|
1754179|NCT00282984|3223652|Superiority or Other||Odds Ratio (OR)|2.82|||<|0.0001||95.0|1.82|4.38||To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary & 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) the LTQR through Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint & key secondary endpoints; included main effects of trtmt group and center as independent var.||Estimates for expected and clinically meaningful varenicline (var) & pbo 4-week CQR for Weeks 9 - 12 of treatment were based on response rates & corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w varenicline & pbo, assuming true 4-week CQR of 0.18 for pbo & 0.40 for var (odds ratio of at least 3.04), and a power of 84% for the 2 key secondary endpts.|
1754180|NCT00282984|3223653|Superiority or Other||Odds Ratio (OR)|3.19|||<|0.0001||95.0|1.97|5.18||To preserve type I family-wise error rate of 0.05, a step-down procedure was used for the analysis of primary & 2 key secondary endpts. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 through 12, 2) CA at Week 52, 3) LTQR through Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint & key secondary endpoints; included main effects of treatment group & center as independent var.||Estimates for expected and clinically meaningful var & pbo 4-week CQR for Weeks 9 - 12 of trtmt were based on response rates & corresponding 95% odds ratio CI from A30510285 and A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpt b/w var & pbo, assuming true 4-week CQR of 0.18 for pbo & 0.40 for var (odds ratio of at least 3.04) & a power of 84% for the 2 key secondary endpts.|
1754181|NCT00282984|3223654|Superiority or Other||Odds Ratio (OR)|6.05|||<|0.0001||95.0|4.13|8.86||To preserve type I family-wise error rate of 0.05, used step-down procedure to analyze primary & 2 key secondary endpoints. Hierarchy of comparisons: 1) 4-week CQR for Weeks 9 thru 12, 2) CA at Week 52, 3) the Long Term Quit Rate (LTQR) thru Week 52.|Regression, Logistic|Logistic regression model fitted to primary endpoint & key secondary endpoints; included main effects of trtmt group and center as independent var.||Estimates for expected & clinically meaningful var & pbo 4-week CQR for Week 9 - 12 of trtmt based on response rates & corresponding 95% OR confidence interval (CI) from A30510285 & A30510366 study results. Total n=700 randomized var or pbo 1:1 should have provided at least 99% power to detect difference in primary endpoint (endpt) between (b/w) var & pbo, assuming true 4-week CQR of 0.18 for pbo & 0.40 for var (OR of at least 3.04), and 84% power for 2 key secondary endpts.|
1754182|NCT00282568|3223716|Non-Inferiority or Equivalence|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|87.2|||||2-Sided|90.0|82.72|91.93|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.|
1754183|NCT00282568|3223717|Non-Inferiority or Equivalence|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|88.15|||||2-Sided|90.0|82.69|93.96|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmax. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform Cmax prior to analysis and the results were transformed back to the original scale for the presentation of results.|
1754184|NCT00282568|3223719|Non-Inferiority or Equivalence|If the 90% Confidence Interval for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|94.97|||||2-Sided|90.0|90.72|99.41|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (steady state was defined as days 1 and 7) and for tacrolimus MR (steady state was defined as days 14 and 21). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.|
1754185|NCT00282464|3223720|Superiority or Other|||||||0.458||||||For all secondary efficacy analyses, no multiple adjustments were made|ANOVA|ANVOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.||Endpoint|
1754186|NCT00282464|3223721|Superiority or Other|||||||0.559||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status.||Endpoint|
1754187|NCT00282464|3223722|Superiority or Other|||||||0.898||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1754188|NCT00282464|3223723|Superiority or Other|||||||0.708||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANOVA|ANOVA model included effects of treatment, rapid cycling, center and prior hospitalization status||Change from baseline to endpoint|
1754189|NCT00282464|3223724|Superiority or Other|||||||0.428||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Baseline to endpoint|
1754190|NCT00282464|3223725|Superiority or Other|||||||0.86||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Change from baseline to endpoint|
1754191|NCT00282464|3223726|Superiority or Other|||||||0.965||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Change from baseline to endpoint|
1754192|NCT00282464|3223727|Superiority or Other|||||||0.0287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.||Overall|
1754193|NCT00282464|3223727|Superiority or Other|||||||0.3964||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.||Week 6|
1754194|NCT00282464|3223727|Superiority or Other|||||||0.0752||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.||Week 5|
1754195|NCT00282464|3223727|Superiority or Other|||||||0.0957||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.||Week 4|
1754196|NCT00282464|3223727|Superiority or Other|||||||0.1807||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.||Week 3|
1754197|NCT00282464|3223727|Superiority or Other|||||||0.0654||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.||Week 2|
1754198|NCT00282464|3223727|Superiority or Other|||||||0.0099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical effect: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction.||Week 1|
1754199|NCT00282464|3223728|Superiority or Other|||||||0.257||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Overall|
1754200|NCT00282464|3223728|Superiority or Other|||||||0.685||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 6|
1754201|NCT00282464|3223728|Superiority or Other|||||||0.349||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 5|
1754202|NCT00282464|3223728|Superiority or Other|||||||0.665||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 4|
1754203|NCT00282464|3223728|Superiority or Other|||||||0.651||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 3|
1754204|NCT00282464|3223728|Superiority or Other|||||||0.088||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 2|
1754205|NCT00282464|3223728|Superiority or Other|||||||0.042||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 1|
1754206|NCT00282464|3223729|Superiority or Other|||||||0.789||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Overall|
1754207|NCT00282464|3223729|Superiority or Other|||||||0.644||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 6|
1754208|NCT00282464|3223729|Superiority or Other|||||||0.642||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 5|
1754209|NCT00282464|3223729|Superiority or Other|||||||0.617||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 4|
1754210|NCT00282464|3223729|Superiority or Other|||||||0.738||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 3|
1758385|NCT00205777|3229639|Superiority or Other|||||||0.18|||||||ANOVA||||
1754211|NCT00282464|3223729|Superiority or Other|||||||0.11||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 2|
1754212|NCT00282464|3223729|Superiority or Other|||||||0.468||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 1|
1754213|NCT00282464|3223730|Superiority or Other|||||||0.82||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1754214|NCT00282464|3223730|Superiority or Other|||||||0.777||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6|
1754215|NCT00282464|3223730|Superiority or Other|||||||0.434||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3|
1754216|NCT00282464|3223731|Superiority or Other|||||||0.797||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1754217|NCT00282464|3223731|Superiority or Other|||||||0.739||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1754218|NCT00282464|3223731|Superiority or Other|||||||0.899||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3|
1754219|NCT00282464|3223732|Superiority or Other|||||||0.404||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1754220|NCT00282464|3223732|Superiority or Other|||||||0.043||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6|
1754221|NCT00282464|3223732|Superiority or Other|||||||0.068||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3|
1754222|NCT00282464|3223733|Superiority or Other|||||||0.295||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1754223|NCT00282464|3223733|Superiority or Other|||||||0.676||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6|
1754224|NCT00282464|3223733|Superiority or Other|||||||0.381||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3|
1754225|NCT00282464|3223734|Superiority or Other|||||||0.848||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1754226|NCT00282464|3223734|Superiority or Other|||||||0.223||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6|
1754227|NCT00282464|3223734|Superiority or Other|||||||0.026||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3|
1754228|NCT00282464|3223735|Superiority or Other|||||||0.71||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1754229|NCT00282464|3223735|Superiority or Other|||||||0.51||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6|
1754230|NCT00282464|3223735|Superiority or Other|||||||0.305||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3|
1754231|NCT00282464|3223736|Superiority or Other|||||||0.873||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1754232|NCT00282464|3223736|Superiority or Other|||||||0.352||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1754233|NCT00282464|3223736|Superiority or Other|||||||0.112||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|ANCOVA model included effects of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3|
1754234|NCT00282464|3223737|Superiority or Other|||||||0.007|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Overall|
1754235|NCT00282464|3223737|Superiority or Other|||||||0.154|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0. The null hypotheses is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups.|
1754236|NCT00282464|3223737|Superiority or Other|||||||0.053|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 5|
1754237|NCT00282464|3223737|Superiority or Other|||||||0.069|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 4|
1754238|NCT00282464|3223737|Superiority or Other|||||||0.038|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 3|
1754239|NCT00282464|3223737|Superiority or Other|||||||0.019|||||||Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 2|
1754240|NCT00282464|3223737|Superiority or Other|||||||0.002||||||No multiple comparison adjustment is applicable. Statistical significance level was 0.05|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 1|
1754241|NCT00282464|3223738|Superiority or Other|||||||0.4033||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1754242|NCT00282464|3223738|Superiority or Other|||||||0.1017||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6|
1754243|NCT00282464|3223738|Superiority or Other|||||||0.9863||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1754244|NCT00282464|3223739|Superiority or Other|||||||0.2206||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1754245|NCT00282464|3223739|Superiority or Other|||||||0.2633||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6|
1754246|NCT00282464|3223739|Superiority or Other|||||||0.0451||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5|
1754247|NCT00282464|3223739|Superiority or Other|||||||0.0618||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4|
1754248|NCT00282464|3223739|Superiority or Other|||||||0.0423||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1754249|NCT00282464|3223739|Superiority or Other|||||||0.0099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2|
1754250|NCT00282464|3223739|Superiority or Other|||||||0.0005||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1|
1754251|NCT00282464|3223740|Superiority or Other|||||||0.6098||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1754252|NCT00282464|3223740|Superiority or Other|||||||0.4124||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6|
1754253|NCT00282464|3223740|Superiority or Other|||||||0.2185||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1754254|NCT00282464|3223741|Superiority or Other|||||||0.7707||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1754255|NCT00282464|3223741|Superiority or Other|||||||0.6394||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6|
1754256|NCT00282464|3223741|Superiority or Other|||||||0.0188||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5|
1754257|NCT00282464|3223741|Superiority or Other|||||||0.013||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4|
1754258|NCT00282464|3223741|Superiority or Other|||||||0.0568||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1754259|NCT00282464|3223741|Superiority or Other|||||||0.0866||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2|
1754260|NCT00282464|3223741|Superiority or Other|||||||0.0056||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1|
1754261|NCT00282347|3223754|Superiority or Other|||||||0.5538|||||||Stratified Wilcoxon-Rank Sum Test||||
1754262|NCT00282295|3223782|Non-Inferiority or Equivalence|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|3.56|||||2-Sided|95.0|0.96|6.45||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup W-135 one month after vaccination|
1754263|NCT00282295|3223782|Non-Inferiority or Equivalence|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|1.82||||||95.0|-2.58|6.25||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine response to meningococcal serogroup Y one month after vaccination.|
1754264|NCT00282295|3223782|Non-Inferiority or Equivalence|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|1.69|||||2-Sided|95.0|-1.69|5.16||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccine compared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup C one month after vaccination.|
1754265|NCT00282295|3223782|Non-Inferiority or Equivalence|Non-inferiority objective was demonstrated if the lower limit was greater than the pre-defined limit of -10%.|Difference in vaccine response rate|-0.21|||||2-Sided|95.0|-4.85|4.43||||||Non-inferiority of Menactra™ vaccine co-administered with Boostrix® vaccinecompared to Menactra™ vaccine administered alone at Month 0 with respect to a vaccine responseto meningococcal serogroup A one month after vaccination.|
1754266|NCT00282295|3223783|Non-Inferiority or Equivalence|Non-inferiority objective was demonstrated if the lower limit was > the pre-defined limit of -10%.|Difference in booster response rate|-1.96|||||2-Sided|95.0|-5.25|-1.25||||||To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PRN one month after vaccination.|
1754267|NCT00282295|3223783|Non-Inferiority or Equivalence|Non-inferiority objective was demonstrated if the lower limit was > the pre-defined limit of -10%.|Difference in booster response rate|-3.39|||||2-Sided|95.0|-7.03|0.15||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to FHA one month after vaccination.|
1754268|NCT00282295|3223783|Non-Inferiority or Equivalence|Non-inferiority objective was demonstrated if the lower limit was > the pre-defined limit of -10%.|Difference in booster response rate|-4.38|||||2-Sided|95.0|-9.91|1.15||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to a booster response to PT one month after vaccination.|
1754269|NCT00282295|3223784|Non-Inferiority or Equivalence|Non-inferiority objective was demonstrated if the lower limit was > the pre-defined limit of 0.67|Adjusted GMC ratio|0.63|||||2-Sided|95.0|0.54|0.72||||||To demonstrate the non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertactin (anti-PRN) GMCs one month after vaccination.|
1754270|NCT00282295|3223784|Non-Inferiority or Equivalence|Non-inferiority objective was demonstrated if the lower limit was > the pre-defined limit of 0.67|Adjusted GMC ratio|0.76|||||2-Sided|95.0|0.69|0.84||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-filamentous hemagglutinin (anti-FHA) GMCs one month after vaccination.|
1754271|NCT00282295|3223784|Non-Inferiority or Equivalence|Non-inferiority objective was demonstrated if the lower limit was greater than (>) the pre-defined limit of 0.67|Adjusted GMC ratio|0.93|||||2-Sided|95.0|0.84|1.03||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to anti-pertussis toxoid (anti-PT) geometric mean antibody concentrations (GMCs) one month after vaccination.|
1754272|NCT00282295|3223785|Non-Inferiority or Equivalence|The non-inferiority objective was demonstrated if the lower limit was greater than (>) the pre-defined limit of -10%.|Difference|0.02|||||2-Sided|95.0|-1.4|1.48||||||Non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared toBoostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-tetanus toxoid (anti-T) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.|
1754273|NCT00282295|3223785|Non-Inferiority or Equivalence|Non-inferiority objective was demonstrated if the lower limit was greater than (>) the pre-defined limit of -10%.|Difference|2.18|||||2-Sided|95.0|0.79|4.17||||||The non-inferiority of Boostrix® vaccine co-administered with Menactra™ vaccine compared to Boostrix® vaccine administered alone at Month 0 with respect to the percentage of subjects with anti-diphtheria toxoid (anti-D) antibody concentrations equal to or greater than (≥) 1.0 IU/mL one month after vaccination.|
1754306|NCT00281658|3223911|Superiority or Other (legacy)||Hazard Ratio (HR)|0.74||||0.0124||95.0|0.58|0.94||two-sided p-value|Log Rank|Stratified log-rank test, stratifying for metastatic disease sites and hormonal status|||
1755494|NCT00265317|3225378|Superiority or Other|||||||0.9807||||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test||||
1754274|NCT00282256|3223804|Non-Inferiority or Equivalence|If the 90% CI for Cmin was found to lie entirely within the 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|91.8|||||2-Sided|90.0|82.6|102.2|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (defined as Day 7) and for tacrolimus MR (defined as Day 14). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.|
1754275|NCT00282256|3223806|Non-Inferiority or Equivalence|If the 90% CI for AUC0-24 was found to lie entirely within the 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|100.9|||||2-Sided|90.0|90.8|112.1|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (defined as Day 7) and for tacrolimus MR (defined as Day 14). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.|
1754276|NCT00282243|3223825|Non-Inferiority or Equivalence|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|81.4|||||2-Sided|90.0|77.88|85.08|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of Cmin. Exposure at steady state was used for tacrolimus (steady state was defined as days 14 and 42) and for tacrolimus MR (steady state was defined as days 28 and 56). The natural log (ln) was used to transform Cmin prior to analysis and the results were transformed back to the original scale for the presentation of results.|
1754277|NCT00282243|3223827|Non-Inferiority or Equivalence|If the 90% CI for the ratio of the natural log-transformed pharmacokinetic parameters fell within an 80% to 125% range, then the exposure between the two formulations was considered to be equivalent.|Ratio of means|88.79|||||2-Sided|90.0|85.42|92.29|||||Tacrolimus/tacrolimus MR ratio of natural log transformed means expressed as a percent.|The method of analysis of variance with repeated measures was used for the comparisons of AUC0-24. Exposure at steady state was used for tacrolimus (steady state was defined as days 14 and 42) and for tacrolimus MR (steady state was defined as days 28 and 56). The natural log (ln) was used to transform AUC0-24 prior to analysis and the results were transformed back to the original scale for the presentation of results.|
1754278|NCT00282152|3223833|Other|||||||0.4|||||||t-test, 2 sided|||Study power was calculated based on the amount of PD medication consumed. We anticipated that the control group (ODT) would have a baseline value of 400 which would increase to 600, and that the treated group (DBS+ODT) would decrease from 400 to 300. A sample size of 12 patients per group (n=15, assuming 20% drop out) would have 80% power to detect a difference in means of 300 assuming that the common standard deviation is 250 using a two group t-test with a 0.05 two-sided significance level.|
1754279|NCT00282152|3223834|Non-Inferiority|Because the purpose of this trial was to provide preliminary safety and tolerability data, the primary hypothesis was that the DBS+ODT group would not worsen more quickly than the ODT group. The primary endpoint was defined as the time to reach a four-point worsening of the UPDRS-III score following a one week treatment washout as assessed by the blinded rater.||||||0.968|||||||Log Rank||||
1754280|NCT00282113|3223835|Superiority or Other||||||>|0.05|||||||ANOVA||||
1754281|NCT00282113|3223836|Superiority or Other|||||||0.06|||||||Chi-squared||||
1754282|NCT00282113|3223837|Superiority or Other||||||>|0.5|||||||Mixed-effects regression||||
1754283|NCT00282087|3223838|Superiority or Other||Hazard Ratio (HR)|-0.564|||||2-Sided|||||||||Estrogen receptor (ER) or progesterone receptor (PR) positive correlation with progression-free survival for patients on study treatment.|
1754284|NCT00282087|3223839|Superiority or Other||Hazard Ratio (HR)|0.207|||||2-Sided|||||||||1988 FIGO Stage correlation with progression-free survival for patients on study treatment.|
1754285|NCT00282087|3223840|Superiority or Other||Hazard Ratio (HR)|-0.906|||||2-Sided|||||||||Progesterone receptor (PR) status correlation with progression-free survival for patients on study treatment.|
1754286|NCT00282087|3223841|Superiority or Other||Hazard Ratio (HR)|-0.708|||||2-Sided|||||||||Estrogen receptor (ER) status correlation with progression-free survival for patients on study treatment.|
1754287|NCT00282087|3223842|Superiority or Other||Hazard Ratio (HR)|-0.00676|||||2-Sided|||||||||Mitotic rate correlation with progression-free survival for patients on study treatment.|
1754288|NCT00282087|3223843|Superiority or Other||Hazard Ratio (HR)|0.101|||||2-Sided|||||||||Uterine serosal involvement correlation with progression-free survival for patients on study treatment.|
1754289|NCT00282087|3223844|Superiority or Other||Hazard Ratio (HR)|0.02|||||2-Sided|||||||||Menopausal status at diagnosis correlation with progression-free survival for patients on study treatment.|
1754290|NCT00282087|3223845|Superiority or Other||Hazard Ratio (HR)|-0.00269|||||2-Sided|||||||||Age correlation with progression-free survival for patients on study treatment.|
1754291|NCT00282087|3223847|Superiority or Other||Two year PFS|78.0||||0.15|2-Sided|95.0|67.0|91.0|||Bayesian Posterior Probability|||The primary endpoint is progression-free survival time, with progression defined as a patient having evidence of recurrent LMS on follow-up evaluation and CT scan. Futility monitoring will be based on the accumulating right-censored PFS time data. The monitoring rules will be based on a Bayesian model.|
1754292|NCT00281918|3223862|Superiority or Other||Hazard Ratio (HR)|0.59|||<|0.0001|2-Sided|95.0|0.49|0.72|||Log Rank||||
1754293|NCT00281918|3223863|Superiority or Other||Odds Ratio (OR)|2.3|||<|0.0001|2-Sided|95.0|1.62|3.28|||Chi-squared||||
1754294|NCT00281918|3223864|Superiority or Other||Hazard Ratio (HR)|0.58|||<|0.0001|2-Sided|95.0|0.48|0.71|||Log Rank||||
1754295|NCT00281918|3223865|Superiority or Other||Hazard Ratio (HR)|0.73||||0.0523|2-Sided|95.0|0.52|1.02|||Log Rank||||
1754296|NCT00281918|3223866|Superiority or Other||Hazard Ratio (HR)|0.57|||<|0.0001||95.0|0.48|0.67|||Log Rank||||
1754297|NCT00281918|3223867|Superiority or Other||Hazard Ratio (HR)|0.68||||0.001|2-Sided|95.0|0.54|0.86|||Log Rank||||
1754298|NCT00281918|3223868|Superiority or Other||Hazard Ratio (HR)|0.57|||<|0.0001|2-Sided|95.0|0.48|0.67|||Log Rank||||
1754299|NCT00281918|3223869|Superiority or Other|||||||0.7882|||||||Log Rank||||
1754307|NCT00281658|3223911|Superiority or Other (legacy)||Hazard Ratio (HR)|0.64||||0.0005|2-Sided|95.0|0.49|0.82||two-sided p-value|Wald Chi-squared|Adjusted for hormonal status, metastatic disease site, initial diagnosis stage, ECOG status, number of metastatic sites, age and disease-free interval|Adjusted HR based on Cox Regression model||
1754308|NCT00281632|3223926|Superiority or Other||Response rate|19.4||||||95.0|8.2|36.0|||||Response rate (CR+PR)||
1754309|NCT00281632|3223926|Superiority or Other||Response rate|21.1||||||95.0|6.1|45.6|||||Response rate (CR+PR)||
1754310|NCT00281632|3223926|Superiority or Other||Response rate|17.6||||||95.0|3.8|43.4|||||Response rate (CR+PR)||
1754311|NCT00281632|3223930|Superiority or Other||Reponse rate|31.0||||||95.0|16.3|48.1|||||50% Response Rate (Normalized and Non-Normalized)||
1754312|NCT00281528|3223989|Superiority or Other (legacy)|||||||0.4476||||||Group comparison was performed between group 260 mg/m^2 ABI-007 every 3 weeks and group 130 mg/m^2 ABI-007 weekly, as based on amended protocol, no type I error adjustment for multiplicity; a priori threshold for statistical significance is 0.05.|Cochran-Mantel-Haenszel|Stratified by study site|||
1754313|NCT00281099|3224001|Non-Inferiority or Equivalence|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.44. The one-sided upper confidence bound for the hazard ratio had to be less than 1.44 for the null hypothesis to be rejected. The threshold of 1.44 was derived by using a noninferiority threshold of a 5 percentage point difference in 24 month survival rates.|Hazard Ratio (HR)|1.26||||||95.0|1.26|1.75|||||This was a non-inferiority analysis, and so a one-sided 95% confidence interval was performed comparing the MVP arm to the VVI 40 arm.|The time from randomization to all cause mortality or last follow-up visit was determined for each subject. The null hypothesis was that the mortality hazard rate for patients with MVP programming was greater than that of patients with VVI40 programming.|
1754314|NCT00281099|3224002|Superiority or Other|||||||0.5183||||||The a priori threshold for statistical significance was 0.05, with no adjustment made for multiple comparisons.|Wilcoxon (Mann-Whitney)|Because the trial was stopped early, only 178 subjects were included in this analysis.||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 36 months was compared using a two-sided test. If a subject died before their 36 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 36 month score.|
1754315|NCT00281099|3224002|Superiority or Other|||||||0.3573||||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 24 months was compared using a two-sided test. If a subject died before their 24 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 24 month score.|
1754316|NCT00281099|3224002|Superiority or Other|||||||0.1399||||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The change in Minnesota Living with Heart Failure Questionnaire score from baseline to 12 months was compared using a two-sided test. If a subject died before their 12 month visit, a value of 105 (worst possible MLWHF score) was imputed for their 12 month score.|
1754317|NCT00281099|3224002|Superiority or Other||||||>|0.15||||||Tests for all 10 KCCQ subscores yielded p-values greater than 0.15 (the a priori threshold for statistical significance was 0.05).|Wilcoxon (Mann-Whitney)|Because the trial was stopped early, only 178 subjects were included in these analyses.||The 10 KCCQ analyses were repeated comparing changes from baseline to 36 months between arms. Again if a subject died prior to their 36 month visit, a value of 0 was imputed for their 36 month score.|
1754318|NCT00281099|3224002|Superiority or Other||||||>|0.15||||||Tests for all ten KCCQ subscores yielded p-values greater than 0.15 (the a priori threshold for statistical significance was 0.05).|Wilcoxon (Mann-Whitney)|||The 10 KCCQ analyses were repeated comparing changes from baseline to 24 months between arms. Again if a subject died prior to their 24 month visit, a value of 0 was imputed for their 24 month score.|
1754319|NCT00281099|3224002|Superiority or Other||||||>|0.0582||||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Overall Clinical Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.|
1754320|NCT00281099|3224002|Superiority or Other||||||>|0.0227||||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Overall Summary Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.|
1754321|NCT00281099|3224002|Superiority or Other||||||>|0.0463||||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Social Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.|
1754322|NCT00281099|3224002|Superiority or Other||||||>|0.0502||||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Quality of Life Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.|
1754323|NCT00281099|3224002|Superiority or Other||||||>|0.0851||||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Self-Efficacy Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.|
1754324|NCT00281099|3224002|Superiority or Other||||||>|0.5422||||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Total Symptom Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.|
1754409|NCT00280566|3224052|Superiority or Other|||||||0.0047|||||||Log Rank|No adjustment made for multiple comparisons||alpha = 0.05 level of significance|
1755495|NCT00265317|3225379|Superiority or Other|||||||0.5982||||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test||||
1754325|NCT00281099|3224002|Superiority or Other||||||>|0.3082||||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Burden Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.|
1754326|NCT00281099|3224002|Superiority or Other||||||>|0.7728||||||The a priori threshold for statistical significance was 0.05, and no adjustment was made for multiple comparisons.|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Frequency Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.|
1754327|NCT00281099|3224002|Superiority or Other||||||>|0.2493||||||No adjustment was made for multiple comparisons, and the a priori threshold for statistical significance was 0.05.|Wilcoxon (Mann-Whitney)|||For the KCCQ Symptom Stability Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.|
1754328|NCT00281099|3224002|Superiority or Other||||||>|0.0073||||||The p-value is not adjusted for multiple comparisons|Wilcoxon (Mann-Whitney)|||For the KCCQ Physical Limitation Score, the change from baseline to 12 months was compared between the two arms, using a two-sided test. If a subject died prior to the time point, a score of 0 was imputed for their 12 month score.|
1754329|NCT00281099|3224003|Superiority or Other|||||||0.5165||||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP & no pacing indication have less mean ventricular pacing through 36 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 36 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.|
1754330|NCT00281099|3224003|Superiority or Other|||||||0.7144||||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP & no pacing indication have less mean ventricular pacing through 24 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 24 months post-implant for patients with MVP programming and no pacing indication was greater than or equal to that of patients with VVI 40 programming and no pacing indication.|
1754331|NCT00281099|3224003|Superiority or Other|||||||0.8984||||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|Alternative hypothesis:patients with MVP & no pacing indication have less mean ventricular pacing through 12 months than similar patients with VVI 40.||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 12 months post-implant for patients with MVP programming was greater than or equal to that of patients with VVI 40 programming.|
1754332|NCT00281099|3224003|Superiority or Other|||||||0.9791||||||The one-sided Wilcoxon Rank Sum test yielded a p-value greater than 0.05, which was the a priori threshold for significance.|Wilcoxon (Mann-Whitney)|||All subjects from the analysis cohort with available data for the time period of interest were included in the corresponding analysis. The null hypothesis was that the average percent ventricular pacing through 6 months post-implant for patients with MVP programming and was greater than or equal to that of patients with VVI 40 programming.|
1754333|NCT00281099|3224005|Superiority or Other|||||||0.0053||||||The a priori threshold for statistical significance was 0.05. The threshold was met, and the null hypothesis rejected.|Log Rank|||Physicians recorded at each scheduled and unscheduled follow-up whether the subject had developed a Class I indication since their last visit. The time from randomization to Class I indication development or last visit if censored was determined for each subject. The null hypothesis was that the hazard rate for time to development of a Class I pacing indication among patients with MVP programming was equal to or greater than that of patients with VVI 40 programming.|
1754334|NCT00281099|3224006|Superiority or Other||Mean Difference (Final Values)|-0.1||||||95.0|-0.1|0.11||||||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 24 to 36 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.|
1754335|NCT00281099|3224006|Superiority or Other||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.261||||||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 12 to 24 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.|
1754336|NCT00281099|3224006|Superiority or Other||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.227||||||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) from 6 to 12 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.|
1754337|NCT00281099|3224006|Superiority or Other||Mean Difference (Final Values)|0.0||||||95.0|0.0|0.145||||||This analysis tested the hypothesis that the average AT/AF burden (hours per day of AT/AF) through 6 months post-implant in patients with no Class I pacing indication and MVP is equal to or greater than that of similar patients with VVI 40. Only subjects with complete AT/AF data for this time interval were included in the analysis.|
1754338|NCT00281099|3224006|Superiority or Other|||||||0.325||||||The a priori threshold for statistical significance was 0.05.|Log Rank|A one-sided test was used.||This analysis tested the null hypothesis that the hazard rate for development of persistent AF(defined as 2 consecutive visits presenting with AT/AF, 7 consecutive days of 22 or more hours per day of AT/AF, or < 7 such days due to a cardioversion) in patients with MVP and no pacing indication was equal to or greater than that of similar patients with VVI 40.|
1754516|NCT00279201|3224141|Superiority or Other|||||||0.726||||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754339|NCT00281099|3224006|Superiority or Other||Mean Difference (Net)|0.15|||||2-Sided|95.0|-100.0|0.8||||||This analysis compared the percentage of days with >20 hours of AT/AF as measured by the device(definition of clinically important AF) between arms. The null hypothesis was that this percentage of days for patients with MVP was equal or greater to that of patients with VVI 40.|
1754340|NCT00281099|3224006|Superiority or Other||Hazard Ratio (HR)|1.22||||0.7166||95.0|1.22|3.0||The threshold for significance was the one-sided upper confidence bound being less than 1.|Andersen-Gill model|||This analysis compared the hazard rates for clinically important AF (defined as a calendar day with >20 hour of AT/AF as measured by the device). The null hypothesis was that this hazard rate for patients with MVP was equal to or greater than that of patients with VVI 40. The pre-specified model had Arm as a covariate, and accounted for time to first event and time between successive events per subject.|
1754341|NCT00281099|3224007|Superiority or Other||Difference in Annualized Rates|0.017||||||95.0|0.017|0.036||||||A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of inappropriately detected non-VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.|
1754342|NCT00281099|3224007|Superiority or Other||Hazard Ratio (HR)|1.31||||||95.0|1.31|1.858|||||Because of the possible correlation within a subject for days with episodes, a subsequent analysis was done using a bootstrap confidence interval for the annualized rate of episodes per patient month.|The pre-specified analysis called for a comparison of the hazard rates of inappropriately detected non-VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (MVP in numerator) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.|
1754343|NCT00281099|3224007|Superiority or Other||Difference in Annualized Rates|-0.015||||||95.0|-0.015|0.033||||||A 95% one-sided bootstrap confidence interval was generated for the MVP - VVI 40 difference in annualized rates of true VT/VF per patient month. If the interval upper bound was less than 0, the null hypothesis of equal rates would be rejected.|
1754344|NCT00281099|3224007|Superiority or Other||Hazard Ratio (HR)|0.949||||||95.0|0.949|1.209|||||Because of the possible correlation within subject of days with episodes, a subsequent analysis was done using a bootstrap confidence interval for the annualized rate of episodes per patient month.|The pre-specified analysis called for a comparison of the hazard rates of true VT/VF between the two arms by way of a one-sided 95% confidence interval on the hazard ratio (values less than one favor MVP) after fitting a model. The unit of time was days, not episodes, so the analysis did not account for multiple episodes on the same day. If the upper bound was less than 1, the null hypothesis of equal hazard rates would be rejected.|
1754345|NCT00281099|3224008|Superiority or Other|||||||0.8403||||||The a priori threshold for significance for Arm was 0.05.|Cumulative Logits Model|Because Composite Mitral Regurgitation Score was measured on the ordinal scale, a GEE cumulative logits model was fit.||"A General Estimating Equation (GEE) Cumulative Logits model was fit with Arm, Time, and their interaction as covariates in the model to test the hypothesis that patients with no pacing indication and MVP programming have different Mitral Regurgation over time than similar patients with VVI 40 programming. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits."|
1754346|NCT00281099|3224009|Superiority or Other||||||>|0.1||||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Models fit with time and arm as covariates.||A linear mixed model was fit for each of the following: Left Atrial Area and Mitral Regurgitation Area; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.|
1754347|NCT00281099|3224010|Superiority or Other|||||||0.949||||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Model fit with time and arm as covariates.||A linear mixed model was fit for Mitral Inflow - Deceleration time; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.|
1754348|NCT00281099|3224011|Superiority or Other||||||>|0.1||||||The a priori threshold for statistical significance for Arm was 0.05, with no correction for multiple comparisons.|Mixed Models Analysis|Models were fit with time and arm as covariates.||A linear mixed model was fit for each of the following: TR Velocity, Mitral Inflow-peak E and Mitral Inflow-peak A; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.|
1754349|NCT00281099|3224012|Superiority or Other|||||||0.0418||||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|The model fit with time and arm as covariates.||A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values of Left Ventricular Sphericity Index over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.|
1754350|NCT00281099|3224013|Superiority or Other||||||>|0.1||||||In each case the a priori threshold for significance for Arm was 0.05.|Mixed Models Analysis|Models were fit with time and arm as covariates.||"Similar models were fit for left ventricle (LV) End Systolic Volume and Left Atrial Volume."|
1754351|NCT00281099|3224013|Superiority or Other||||||>|0.0424||||||The a priori threshold for statistical significance for Arm was 0.05, with no correction for multiple comparisons.|Mixed Models Analysis|The model was fit with time and arm as covariates.||"A linear mixed model was fit to test whether patients with MVP and no pacing indication had a different values for left ventricular end diastolic volume (LVEDV) over time than similar patients with VVI 40. A two-sided test was used. Data were collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits."|
1754352|NCT00281099|3224014|Superiority or Other||||||>|0.1||||||The a priori threshold for significance for Arm was 0.05, with no adjustment for multiple analyses.|Mixed Models Analysis|Models were fit with time and arm as covariates.||A linear mixed model was fit for each of the following: LV Ejection Fraction and LV Fractional Shortening; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Two-sided tests were used. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.|
1754353|NCT00281099|3224015|Superiority or Other||||||>|0.1||||||In each case the a priori threshold for significance for Arm was 0.05.|Mixed Models Analysis|Model fit with time and arm as covariates, the interaction between them included. Interaction shown to not be significant and model refit without it.||A linear mixed model was fit for each of the followoing: LVEDD, LVESD, Septal Wall Thickness, and Posterior Wall Thickness; the purpose was to test whether patients with MVP and no pacing indication over time had a different average value for that measure than patients with VVI and no pacing indication. Data were also collected from the 36 month visits but were excluded due to the trial being stopped early and only a subset of patients having data for those visits.|
1754354|NCT00281099|3224016|Superiority or Other||||||>|0.05||||||The a priori alpha level for each covariate was 0.05. The p-value outcome provided is for the randomization arm main effect and all interaction terms between randomization arm and time.|Cumulative Logit Model|The analysis included data for all four time points (baseline, 12, 24, and 36 months) and all NYHA levels.||The null hypothesis for this analysis was the same as for the prior analysis: that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. In this analysis, however, death was considered a 5th category in addition to NYHA I-IV. An interaction term for time and randomization arm was also included.|
1754355|NCT00281099|3224016|Superiority or Other||||||>|0.05||||||The a priori alpha level for each covariate was 0.05. The p-value outcome provided is for the randomization arm main effect and all interactions between randomization arm and time.|Cumulative Logits Model|The analysis included data for all four time points (baseline, 12, 24, and 36 months) and all NYHA levels.||A model with covariates for time and randomization arm was fit to test the null hypothesis that the risk of worsening NYHA status over time among patients with MVP programming was equal to that of patients with VVI 40 programming. This analysis combined NYHA IV and Death into one category. The model included interaction terms for time and randomization arm.|
1754356|NCT00281099|3224017|Non-Inferiority or Equivalence|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.241. The one-sided upper confidence bound for the hazard ratio had to be less than 1.241 for the null hypothesis to be rejected. The threshold of 1.241 was derived by using a non-inferiority threshold of a 5 percentage point difference in 24 month HF event-free rates.|Hazard Ratio (HR)|1.029||||||95.0|1.029|1.381||||||This is a multiple events survival analysis, and so the time from randomization to first HF event, time between successive HF events, and time from last HF event to last follow-up visit was determined for each subject. Since non-inferiority analysis is intended to prove that one therapy is equivalent or superior to another therapy, the null hypothesis being tested is that the worsening HF hazard rate for patients with MVP programming is greater than that of patients with VVI 40 programming.|
1754357|NCT00281099|3224018|Non-Inferiority or Equivalence|A non-inferiority analysis was performed, with the hazard ratio as the parameter of interest and the non-inferiority threshold of 1.21. The one-sided upper confidence bound for the hazard ratio had to be less than 1.21 for the null hypothesis to be rejected. The threshold of 1.21 was derived by using a noninferiority threshold of a 5 percentage point difference in 24 month event-free rates.|Hazard Ratio (HR)|1.139||||||96.3|1.139|1.59|||||4 interim analyses were performed & the O'Brien-Fleming alpha-spending function required a 96.3% confidence interval.|"This is a multiple events survival analysis, with time to first primary endpoint, time between successive endpoints, and time from last endpoint to last follow-up visit determined for each subject. The null hypothesis is that the mortality/ heart failure (HF) urgent care/HF hospitalization hazard rate for patients with no Class I pacing indication and MVP is greater than that of similar patients with VVI 40."|
1754358|NCT00280566|3224044|Superiority or Other||Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.32||0.5771|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754359|NCT00280566|3224044|Superiority or Other||Mean Difference (Final Values)|0.44|Standard Error of the Mean|0.32||0.1653|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754360|NCT00280566|3224044|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Deviation|0.46||0.9953|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754361|NCT00280566|3224044|Superiority or Other||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.28||0.3039|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754362|NCT00280566|3224044|Superiority or Other||Mean Difference (Final Values)|0.51|Standard Error of the Mean|0.26||0.0443|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754410|NCT00280566|3224053|Superiority or Other|||||||0.0104|||||||Log Rank|alpha = 0.05 level of significance||Equality of Survival Curves across the treatment groups.|
1754363|NCT00280566|3224044|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.29||0.8117|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754364|NCT00280566|3224045|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.27||0.2394|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754365|NCT00280566|3224045|Superiority or Other||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.35||0.2649|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754366|NCT00280566|3224045|Superiority or Other||Mean Difference (Final Values)|-0.56|Standard Error of the Mean|0.27||0.038|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754367|NCT00280566|3224045|Superiority or Other||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.32||0.1084|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754368|NCT00280566|3224045|Superiority or Other||Mean Difference (Final Values)|0.05|Standard Error of the Mean|0.25||0.8541|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754369|NCT00280566|3224045|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.22||0.9538|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754370|NCT00280566|3224046|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.88||0.9632|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754371|NCT00280566|3224046|Superiority or Other||Mean Difference (Final Values)|0.36|Standard Error of the Mean|1.1||0.741|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754372|NCT00280566|3224046|Superiority or Other||Mean Difference (Final Values)|-0.85|Standard Error of the Mean|1.47||0.5627|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754373|NCT00280566|3224046|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|1.23||0.9745|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate|
1754374|NCT00280566|3224046|Superiority or Other||Mean Difference (Final Values)|0.89|Standard Error of the Mean|0.93||0.3414|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754375|NCT00280566|3224046|Superiority or Other||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.93||0.5954|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754376|NCT00280566|3224047|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.82||0.9972|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754377|NCT00280566|3224047|Superiority or Other||Mean Difference (Final Values)|0.9|Standard Error of the Mean|0.68||0.1847|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754430|NCT00279812|3224110|Other||||||<|0.05|||||||ANOVA||||
1754378|NCT00280566|3224047|Superiority or Other||Mean Difference (Final Values)|0.97|Standard Error of the Mean|0.78||0.2116|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754379|NCT00280566|3224047|Superiority or Other||Mean Difference (Final Values)|0.41|Standard Error of the Mean|0.76||0.5873|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754380|NCT00280566|3224047|Superiority or Other||Mean Difference (Final Values)|-0.43|Standard Error of the Mean|0.82||0.5992|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754381|NCT00280566|3224047|Superiority or Other||Mean Difference (Final Values)|-1.49|Standard Error of the Mean|0.87||0.0861|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754382|NCT00280566|3224047|Superiority or Other||Mean Difference (Final Values)|-1.34|Standard Error of the Mean|0.91||0.1412|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate|
1754383|NCT00280566|3224047|Superiority or Other||Mean Difference (Final Values)|-2.29|Standard Error of the Mean|0.75||0.0023|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754384|NCT00280566|3224048|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.18||0.1666|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754385|NCT00280566|3224048|Superiority or Other||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.18||0.1317|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754386|NCT00280566|3224048|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.19||0.0085|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754387|NCT00280566|3224048|Superiority or Other||Mean Difference (Final Values)|-0.18|Standard Error of the Mean|0.16||0.276|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754388|NCT00280566|3224048|Superiority or Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.16||0.3413|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754389|NCT00280566|3224048|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.17||0.0188|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754390|NCT00280566|3224048|Superiority or Other||Mean Difference (Final Values)|-0.27|Standard Error of the Mean|0.17||0.1167|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754391|NCT00280566|3224048|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.15||0.0013|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754392|NCT00280566|3224049|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.14||0.8162|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754431|NCT00279591|3224119|Superiority or Other|||||||0.03|||||||Fisher Exact||||
1754393|NCT00280566|3224049|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.15||0.7301|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754394|NCT00280566|3224049|Superiority or Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.16||0.146|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754395|NCT00280566|3224049|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.13||0.2791|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754396|NCT00280566|3224049|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.11||0.9166|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754397|NCT00280566|3224049|Superiority or Other||Mean Difference (Final Values)|-0.18|Standard Error of the Mean|0.1||0.0734|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754398|NCT00280566|3224049|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.13||0.3677|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754399|NCT00280566|3224049|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.09||0.0088|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754400|NCT00280566|3224050|Superiority or Other||Mean Difference (Final Values)|-1.71|Standard Error of the Mean|0.71||0.0161|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754401|NCT00280566|3224050|Superiority or Other||Mean Difference (Final Values)|-2.21|Standard Error of the Mean|0.98||0.0242|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754402|NCT00280566|3224050|Superiority or Other||Mean Difference (Final Values)|-3.01|Standard Error of the Mean|0.83||0.0003|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754403|NCT00280566|3224050|Superiority or Other||Mean Difference (Final Values)|-1.98|Standard Error of the Mean|0.82||0.0162|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754404|NCT00280566|3224050|Superiority or Other||Mean Difference (Final Values)|-1.25|Standard Error of the Mean|0.71||0.0758|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754405|NCT00280566|3224050|Superiority or Other||Mean Difference (Final Values)|-0.63|Standard Error of the Mean|0.62||0.3074|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754406|NCT00280566|3224050|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.62||0.7515|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance|Mean Difference (Final Values) = Least Squares Mean|Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754407|NCT00280566|3224050|Superiority or Other||Mean Difference (Final Values)|-0.85|Standard Error of the Mean|0.55||0.1247|||||||MMRM ANCOVA|MMRM ANCOVA = mixed effects repeated measures analysis of covariance.|Mean Difference (Final Values) = Least Squares Mean|Week 1: Difference in Change during Period 2 MMRM ANCOVA: center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.|
1754408|NCT00280566|3224051|Superiority or Other|||||||0.0205||||||No adjustment made for multiple comparisons|Log Rank|||alpha = 0.05 level of significance|
1754411|NCT00280059|3224079|Superiority or Other||Odds Ratio (OR)|1.09||||0.6804|2-Sided|95.0|0.73|1.63|||Regression, Logistic|||Week 56 (termination): dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.|
1754412|NCT00280059|3224079|Superiority or Other||Odds Ratio (OR)|1.14||||0.5096|2-Sided|95.0|0.78|1.66|||Regression, Logistic|||Week 32: dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.|
1754413|NCT00280059|3224079|Superiority or Other||Odds Ratio (OR)|1.37||||0.0683|2-Sided|95.0|0.98|1.93|||Regression, Logistic|||Week 8: dichotomized sleep assessment analyzed using a logistic regression model for repeated measures with fixed effects for treatment, geographical region, the average hours per night of sleep at baseline as a continuous covariate, time, and treatment-by-time interaction. The within subject covariance structure assumes an auto-regressive of order one covariance structure.|
1754414|NCT00280059|3224080|Superiority or Other||Mean Difference (Final Values)|0.6||||0.0186|2-Sided|95.0|0.1|1.1|||ANCOVA|||Depression; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.|
1754415|NCT00280059|3224080|Superiority or Other||Mean Difference (Final Values)|0.8||||0.0025|2-Sided|95.0|0.3|1.4|||ANCOVA|||Anxiety; model includes treatment and geographical cluster as fixed effects and respective baseline scores as a continuous covariate.|
1754416|NCT00280059|3224090|Superiority or Other||Risk Ratio (RR)|1.47||||0.0003|2-Sided|95.0|1.19|1.8||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio < 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.|
1754417|NCT00280059|3224091|Superiority or Other||Risk Ratio (RR)|1.36||||0.0744|2-Sided|95.0|0.97|1.91||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio < 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.|
1754418|NCT00280059|3224092|Superiority or Other||Risk Ratio (RR)|6.52||||0.0025|2-Sided|95.0|1.93|22.04||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio < 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.|
1754419|NCT00280059|3224093|Superiority or Other||Risk Ratio (RR)|1.19||||0.2537|2-Sided|95.0|0.88|1.6||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio < 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.|
1754420|NCT00280059|3224094|Superiority or Other||Risk Ratio (RR)|1.06||||0.8047|2-Sided|95.0|0.65|1.74||Nominal value for 2-sided test calculated using Cox proportional hazards model adjusted for geographical cluster.|Cox proportional hazards model|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio < 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.|
1754421|NCT00280059|3224095|Superiority or Other||Risk Ratio (RR)|0.74||||0.0034|2-Sided|95.0|0.6|0.9||Nominal value for 2-sided test calculated using Cox proportional hazards model, adjusted for geographic regions.|Regression, Cox|||Risk ratio=hazard ratio estimated from the Cox proportional hazards model for assessing a treatment difference, risk ratio > 1 is in favor of pregabalin. The 95% confidence interval is for the true risk ratio.|
1754422|NCT00280059|3224096|Non-Inferiority or Equivalence|Non-inferiority margin for the proportion of seizure free participants set at 10%; non-inferiority declared if the lower bound of the 95% confidence interval (CI) of the difference in seizure-free proportion between pregabalin and lamotrigine was no more than 10% in favor of lamotrigine, but 0 was contained within the lower bound of the CI. Interpretation of superiority required lower bound of CI did not contain 0 in favor of pregabalin.|Mean Difference (Final Values)|-0.16|||||2-Sided|95.0|-0.24|-0.09|||||95% confidence interval for the true difference in proportions, as well as a one-sided test at α=0.025; confidence interval adjusted for centers clustered within a geographical region, with upper and lower confidence limits.|Analysis of the binary response variable for 6 consecutive months seizure freedom analyzed by comparing the proportions of favorable responders between the two treatment groups after stratifying by clusters and correcting for skewness (Gart and Nam, 1990). Percentage can be obtained by multiplying proportion by 100.|
1754423|NCT00279955|3224097|Superiority or Other||Hazard Ratio (HR)|1.8|Standard Deviation|0.311||0.0578|2-Sided|95.0|0.98|3.31|||Regression, Cox||A Cox regression model has been used here, and the estimated parameter has been adjusted by including covariates age, gender, and NYHA class at 6 months.||
1754424|NCT00279955|3224098|Superiority or Other||Cox Proportional Hazard|1.9|Standard Deviation|0.277||0.0185|2-Sided|95.0|1.11|3.27|||Regression, Cox||The estimated parameter in a Cox regression model was adjusted by age, gender, NYHA class at 6 month visit, ACE/ARB at 6 months, and and at least one day where CRT pacing <90% in last 21 days of DREP.||
1754425|NCT00279955|3224099|Superiority or Other||Cox Proportional Hazard|2.07|Standard Deviation|0.292||0.0119|2-Sided|95.0|1.17|3.67|||Regression, Cox||The estimated parameter in a Cox regression model was adjusted by age, gender, New York Heart Association (NYHA) class at 6 month visit, Angiotensin Converting Enzyme (ACE)/Angiotensin Receptor Blocker (ARB) at 6 months, and Diuretics at 6 month.||
1754426|NCT00279916|3224106|Superiority|||||||0.24|||||||Chi-squared||||
1754427|NCT00279916|3224107|Superiority|||||||0.18|||||||Chi-squared||||
1754428|NCT00279812|3224108|Other|||||||0.05|||||||Mixed Models Analysis||||
1754429|NCT00279812|3224109|Other|||||||0.05|||||||Mixed Models Analysis||||
1754432|NCT00279305|3224123|Superiority or Other (legacy)||Mean Difference (Final Values)|0.139|Standard Error of the Mean|0.104||0.05|2-Sided|95.0|-0.0699|0.348|||ANCOVA|||The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the “AUC mean” and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.|
1754433|NCT00279214|3224124|Superiority or Other|||||||0.234||||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted||||
1754434|NCT00279214|3224124|Superiority or Other|||||||0.128||||||24-Hour p-value|Repeated Measures - propensity adjusted||||
1754435|NCT00279214|3224126|Superiority or Other|||||||0.002||||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted||||
1754436|NCT00279214|3224126|Superiority or Other|||||||0.03||||||24-Hour p-value|Repeated Measures - propensity adjusted||||
1754437|NCT00279214|3224126|Superiority or Other|||||||0.129||||||12-Hour p-value|Repeated Measures - propensity adjusted||||
1754438|NCT00279214|3224126|Superiority or Other|||||||0.552||||||Baseline p-value|Repeated Measures - propensity adjusted||||
1754439|NCT00279214|3224128|Superiority or Other|||||||0.165|||||||Repeated Measures - propensity adjusted||||
1754440|NCT00279214|3224129|Superiority or Other|||||||0.575||||||24-Hour p-value|Repeated Measures - propensity adjusted||||
1754441|NCT00279214|3224129|Superiority or Other|||||||0.686||||||Baseline p-value|Repeated Measures - propensity adjusted||||
1754442|NCT00279214|3224130|Superiority or Other|||||||0.623||||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted||||
1754443|NCT00279214|3224130|Superiority or Other|||||||0.81||||||24-Hour p-value|Repeated Measures - propensity adjusted||||
1754444|NCT00279214|3224130|Superiority or Other|||||||0.083||||||12-Hour p-value|Repeated Measures - propensity adjusted||||
1754445|NCT00279214|3224130|Superiority or Other|||||||0.242||||||Baseline p-value|Repeated Measures - propensity adjusted||||
1754446|NCT00279214|3224131|Superiority or Other|||||||0.027||||||6-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted||||
1754447|NCT00279214|3224131|Superiority or Other|||||||0.061||||||6-Hour p-value|Repeated Measures - propensity adjusted||||
1754448|NCT00279214|3224132|Superiority or Other|||||||0.702||||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted||||
1754449|NCT00279214|3224132|Superiority or Other|||||||0.704||||||24-Hour p-value|Repeated Measures - propensity adjusted||||
1754450|NCT00279214|3224133|Superiority or Other|||||||0.871||||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted||||
1754451|NCT00279214|3224133|Superiority or Other|||||||0.442||||||24-Hour p-value|Repeated Measures - propensity adjusted||||
1754452|NCT00279214|3224134|Superiority or Other|||||||0.478||||||P-value for 96 Hour Change from Baseline.|Mixed Models Analysis|Model: Outcome=Therapy + Sedative Indicator + Time + Therapy*Time + Propensity Score|||
1754453|NCT00279214|3224135|Superiority or Other|||||||0.281||||||24-Hour Change from Baseline p-value|Repeated Measures - propensity adjusted||||
1754454|NCT00279214|3224135|Superiority or Other|||||||0.238|||||||Repeated Measures - propensity adjusted|||24-Hour p-value|
1754455|NCT00279201|3224136|Superiority or Other|||||||0.271||||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754456|NCT00279201|3224136|Superiority or Other|||||||0.377||||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754457|NCT00279201|3224136|Superiority or Other|||||||0.179||||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754458|NCT00279201|3224136|Superiority or Other|||||||0.552||||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.|||
1754459|NCT00279201|3224136|Superiority or Other|||||||0.99||||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754460|NCT00279201|3224136|Superiority or Other|||||||0.812||||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754461|NCT00279201|3224136|Superiority or Other|||||||0.566||||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754462|NCT00279201|3224136|Superiority or Other|||||||0.77||||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.|||
1754463|NCT00279201|3224137|Superiority or Other|||||||0.514||||||P-value for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, and TZD use.|||
1754464|NCT00279201|3224137|Superiority or Other|||||||0.42||||||P-value is for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, and TZD use.|||
1754465|NCT00279201|3224137|Superiority or Other|||||||0.754||||||P-value for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.|||
1754466|NCT00279201|3224137|Superiority or Other|||||||0.917||||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.|||
1754467|NCT00279201|3224138|Superiority or Other|||||||0.178||||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754468|NCT00279201|3224138|Superiority or Other|||||||0.161||||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754469|NCT00279201|3224138|Superiority or Other|||||||0.108||||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754470|NCT00279201|3224138|Superiority or Other|||||||0.657||||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754471|NCT00279201|3224138|Superiority or Other|||||||0.59||||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754472|NCT00279201|3224138|Superiority or Other|||||||0.949||||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754473|NCT00279201|3224138|Superiority or Other|||||||0.445||||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754474|NCT00279201|3224138|Superiority or Other|||||||0.73||||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754475|NCT00279201|3224138|Superiority or Other|||||||0.949||||||P-value is for Hypoglycemic episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754476|NCT00279201|3224138|Superiority or Other|||||||0.623||||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754477|NCT00279201|3224139|Superiority or Other|||||||0.039||||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.|||
1754478|NCT00279201|3224139|Superiority or Other|||||||0.273||||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.|||
1754479|NCT00279201|3224139|Superiority or Other|||||||0.166||||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.|||
1754480|NCT00279201|3224139|Superiority or Other|||||||0.123||||||P-value is for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.|||
1754481|NCT00279201|3224139|Superiority or Other|||||||0.25||||||P-value is for Hypoglycemia episodes at endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.|||
1754482|NCT00279201|3224139|Superiority or Other|||||||0.855||||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.|||
1754483|NCT00279201|3224139|Superiority or Other|||||||0.226||||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.|||
1754484|NCT00279201|3224139|Superiority or Other|||||||0.188||||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.|||
1754485|NCT00279201|3224139|Superiority or Other|||||||0.953||||||P-value is for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.|||
1754486|NCT00279201|3224139|Superiority or Other|||||||0.953||||||P-value is for Hypoglycemia episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country and TZD use.|||
1754487|NCT00279201|3224140|Superiority or Other|||||||0.903||||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754488|NCT00279201|3224140|Superiority or Other|||||||0.398||||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754489|NCT00279201|3224140|Superiority or Other|||||||0.335||||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754490|NCT00279201|3224140|Superiority or Other|||||||0.493||||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754491|NCT00279201|3224140|Superiority or Other|||||||0.602||||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754492|NCT00279201|3224140|Superiority or Other|||||||0.438||||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754493|NCT00279201|3224140|Superiority or Other|||||||0.797||||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754494|NCT00279201|3224140|Superiority or Other|||||||0.449||||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754495|NCT00279201|3224140|Superiority or Other|||||||0.766||||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754496|NCT00279201|3224140|Superiority or Other|||||||0.902||||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754497|NCT00279201|3224140|Superiority or Other|||||||0.926||||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754498|NCT00279201|3224140|Superiority or Other|||||||0.566||||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754499|NCT00279201|3224140|Superiority or Other|||||||0.654||||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754500|NCT00279201|3224140|Superiority or Other|||||||0.859||||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754501|NCT00279201|3224140|Superiority or Other|||||||0.904||||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754502|NCT00279201|3224140|Superiority or Other|||||||0.88||||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754503|NCT00279201|3224140|Superiority or Other|||||||0.636||||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754504|NCT00279201|3224140|Superiority or Other|||||||0.352||||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754505|NCT00279201|3224140|Superiority or Other|||||||0.61||||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754506|NCT00279201|3224140|Superiority or Other|||||||0.704||||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754507|NCT00279201|3224140|Superiority or Other|||||||0.205||||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754508|NCT00279201|3224140|Superiority or Other|||||||0.837||||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use in the model.|||
1754509|NCT00279201|3224141|Superiority or Other|||||||0.098||||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754510|NCT00279201|3224141|Superiority or Other|||||||0.199||||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754511|NCT00279201|3224141|Superiority or Other|||||||0.064||||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754512|NCT00279201|3224141|Superiority or Other|||||||0.166||||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754513|NCT00279201|3224141|Superiority or Other|||||||0.745||||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, and TZD use in model.|||
1754514|NCT00279201|3224141|Superiority or Other|||||||0.345||||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754515|NCT00279201|3224141|Superiority or Other|||||||0.978||||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754517|NCT00279201|3224141|Superiority or Other|||||||0.575||||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754518|NCT00279201|3224141|Superiority or Other|||||||0.467||||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, and TZD use in model.|||
1754519|NCT00279201|3224142|Superiority or Other|||||||0.098||||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754520|NCT00279201|3224142|Superiority or Other|||||||0.199||||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754521|NCT00279201|3224142|Superiority or Other|||||||0.064||||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754522|NCT00279201|3224142|Superiority or Other|||||||0.166||||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754523|NCT00279201|3224142|Superiority or Other|||||||0.345||||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754524|NCT00279201|3224142|Superiority or Other|||||||0.978||||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754525|NCT00279201|3224142|Superiority or Other|||||||0.726||||||P-value is for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754526|NCT00279201|3224142|Superiority or Other|||||||0.575||||||P-value is for Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754527|NCT00279201|3224142|Superiority or Other|||||||0.467||||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.|||
1754528|NCT00279201|3224142|Superiority or Other|||||||0.745||||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.|||
1754529|NCT00279201|3224143|Superiority or Other|||||||0.861||||||P-value is for Mean all BG values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754530|NCT00279201|3224143|Superiority or Other|||||||0.127||||||P-value is for Mean AM/PM 2hr BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754531|NCT00279201|3224143|Superiority or Other|||||||0.491||||||P-value is for Mean combined AM/PM 2hr PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754532|NCT00279201|3224143|Superiority or Other|||||||0.487||||||P-value is for Mean all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754533|NCT00279201|3224143|Superiority or Other|||||||0.105||||||P-value is for Mean all 2-hour PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754534|NCT00279201|3224143|Superiority or Other|||||||0.003||||||P-value is for Mean all mealtime excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754535|NCT00279201|3224143|Superiority or Other|||||||0.542||||||P-value is for PM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754536|NCT00279201|3224143|Superiority or Other||||||<|0.001||||||P-value is for Midday 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754537|NCT00279201|3224143|Superiority or Other||||||<|0.081||||||P-value is for AM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754538|NCT00279201|3224143|Superiority or Other||||||<|0.071||||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754539|NCT00279201|3224143|Superiority or Other||||||<|0.58||||||P-value is for PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754540|NCT00279201|3224143|Superiority or Other||||||<|0.951||||||P-value is for PM premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754541|NCT00279201|3224143|Superiority or Other||||||<|0.004||||||P-value is for Midday 2-hour (hr) PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754542|NCT00279201|3224143|Superiority or Other||||||<|0.578||||||P-value is for Midday premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754543|NCT00279201|3224143|Superiority or Other||||||<|0.53||||||P-value is for AM 2-hour postprandial (PP) BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754544|NCT00279201|3224143|Superiority or Other||||||<|0.131||||||P-value is for Mean fast blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754545|NCT00279201|3224143|Superiority or Other||||||<|0.639||||||P-value is for Mean all BG values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754546|NCT00279201|3224143|Superiority or Other||||||<|0.516||||||P-value is for Mean AM/PM 2hr BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754547|NCT00279201|3224143|Superiority or Other||||||<|0.372||||||P-value is for Mean combined AM/PM 2hr PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754548|NCT00279201|3224143|Superiority or Other||||||<|0.711||||||P-value is for Mean all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754549|NCT00279201|3224143|Superiority or Other||||||<|0.573||||||P-value is for Mean all 2-hour PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754550|NCT00279201|3224143|Superiority or Other||||||<|0.625||||||P-value is for Mean all mealtime excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754551|NCT00279201|3224143|Superiority or Other||||||<|0.348||||||P-value is for PM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754552|NCT00279201|3224143|Superiority or Other||||||<|0.933||||||P-value is for Midday 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754553|NCT00279201|3224143|Superiority or Other||||||<|0.953||||||P-value is for AM 2-hour BG excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754554|NCT00279201|3224143|Superiority or Other||||||<|0.813||||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754555|NCT00279201|3224143|Superiority or Other||||||<|0.613||||||P-value is for PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754556|NCT00279201|3224143|Superiority or Other||||||<|0.648||||||P-value is for PM premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754557|NCT00279201|3224143|Superiority or Other||||||<|0.917||||||P-value is for Midday 2-hour (hr) PP BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754558|NCT00279201|3224143|Superiority or Other||||||<|0.842||||||P-value is for Midday premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754559|NCT00279201|3224143|Superiority or Other||||||<|0.305||||||P-value is for AM 2-hour postprandial (PP) BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754560|NCT00279201|3224143|Superiority or Other||||||<|0.241||||||P-value is for Mean fast blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754561|NCT00279201|3224144|Superiority or Other|||||||1||||||P-value is for <=6.5%.|Fisher Exact||||
1754562|NCT00279201|3224144|Superiority or Other|||||||1||||||P-value is for <7.0%.|Fisher Exact||||
1754563|NCT00279201|3224144|Superiority or Other|||||||0.676||||||P-value is for <=7.0%.|Fisher Exact||||
1754564|NCT00279201|3224144|Superiority or Other|||||||0.799||||||P-value is for <=6.5%.|Fisher Exact||||
1754565|NCT00279201|3224144|Superiority or Other|||||||0.021||||||P-value is for <7.0%.|Fisher Exact||||
1754566|NCT00279201|3224144|Superiority or Other|||||||0.027||||||P-value is for <=7.0%.|Fisher Exact||||
1754567|NCT00279201|3224145|Superiority or Other|||||||0.271||||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754568|NCT00279201|3224145|Superiority or Other|||||||0.552||||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.|||
1754569|NCT00279201|3224145|Superiority or Other|||||||0.99||||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754570|NCT00279201|3224145|Superiority or Other|||||||0.77||||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use in model.|||
1754571|NCT00279201|3224146|Superiority or Other|||||||0.425||||||P-value is for Average of all blood glucose.|ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.|||
1754572|NCT00279201|3224146|Superiority or Other|||||||0.516||||||P-value is for Mean of post-meals blood glucose.|ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.|||
1754573|NCT00279201|3224147|Superiority or Other|||||||0.035||||||P-value is for Average of all blood glucose.|ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.|||
1754574|NCT00279201|3224147|Superiority or Other|||||||0.01||||||P-value is for Mean of all post meals blood glucose.|ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.|||
1754575|NCT00279201|3224148|Superiority or Other|||||||0.553|||||||ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.|||
1754576|NCT00279201|3224149|Superiority or Other|||||||0.004|||||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.|||
1754577|NCT00279201|3224150|Superiority or Other|||||||0.848||||||P-value is for Sulfonylurea/metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.|||
1754578|NCT00279201|3224150|Superiority or Other|||||||0.258||||||P-value is for Metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.|||
1754579|NCT00279201|3224150|Superiority or Other|||||||0.048||||||P-value is for Sulfonylurea/metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.|||
1754580|NCT00279201|3224150|Superiority or Other|||||||0.006||||||P-value is for Sulfonylurea/TZD|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.|||
1754581|NCT00279201|3224151|Superiority or Other|||||||0.849||||||P-value is for Sulfonylurea/metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.|||
1754582|NCT00279201|3224151|Superiority or Other|||||||0.132||||||P-value is for Metformin/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.|||
1754583|NCT00279201|3224151|Superiority or Other|||||||0.025||||||P-value is for Sulfonylurea/metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.|||
1754584|NCT00279201|3224151|Superiority or Other|||||||0.037||||||P-value is for Sulfonylurea/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.|||
1754585|NCT00279201|3224152|Superiority or Other|||||||0.032|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.|||
1754586|NCT00279201|3224153|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.|||
1754587|NCT00279201|3224154|Superiority or Other|||||||0.043|||||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.|||
1754588|NCT00279201|3224155|Superiority or Other||||||<|0.001|||||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.|||
1754589|NCT00279201|3224156|Superiority or Other|||||||0.738|||||||Cochran-Mantel-Haenszel|Stratified by country, TZD use, and sulfo use.|||
1754590|NCT00279201|3224157|Superiority or Other|||||||0.028|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and Sulfo use.|||
1754591|NCT00279201|3224158|Superiority or Other|||||||0.708|||||||ANOVA|From ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.|||
1754592|NCT00279201|3224159|Superiority or Other|||||||0.036|||||||ANOVA|ANOVA with maintained goal/did not maintain goal, country, TZD use, and sulfo use in model.|||
1754593|NCT00279201|3224160|Superiority or Other|||||||0.02||||||P-value is for Change Week 24 to Week 120 endpoint.|ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.|||
1754594|NCT00279201|3224160|Superiority or Other|||||||0.017||||||P-Value is for Change from baseline to endpoint.|ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use and sulfo use in the model.|||
1754595|NCT00279201|3224160|Superiority or Other|||||||0.204||||||P-value is for Baseline at Week 0.|ANOVA|ANOVA used with treatment, country, TZD use and Sulfo use in the model.|||
1754596|NCT00279201|3224161|Superiority or Other|||||||0.004||||||P-value is for Change.|ANCOVA|ANCOVA model with treatment, baseline, country, TZD use and sulfo use.|||
1754597|NCT00279201|3224162|Superiority or Other|||||||0.208||||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1758386|NCT00205777|3229639|Superiority or Other|||||||0.97|||||||ANOVA||||
1754598|NCT00279201|3224162|Superiority or Other|||||||0.2||||||P-value is for Severe episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754599|NCT00279201|3224162|Superiority or Other|||||||0.021||||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754600|NCT00279201|3224162|Superiority or Other|||||||0.065||||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754601|NCT00279201|3224162|Superiority or Other|||||||0.071||||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754602|NCT00279201|3224162|Superiority or Other|||||||0.497||||||P-value for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754603|NCT00279201|3224163|Superiority or Other|||||||0.391||||||P-value is for Severe episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754604|NCT00279201|3224163|Superiority or Other|||||||0.893||||||P-value is for Severe episodes endpoint.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.|||
1754605|NCT00279201|3224163|Superiority or Other|||||||0.253||||||P-value is for Nocturnal episodes overall.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.|||
1754606|NCT00279201|3224163|Superiority or Other|||||||0.397||||||P-value is for Nocturnal episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754607|NCT00279201|3224163|Superiority or Other|||||||0.006||||||P-Value for Overall hypoglycemia episodes.|Cochran-Mantel-Haenszel|Controlling for country, TZD use, and sulfo use.|||
1754608|NCT00279201|3224163|Superiority or Other|||||||0.37||||||P-value is for Overall hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754609|NCT00279201|3224164|Superiority or Other||||||<|0.001||||||P-value is for Endpoint.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.|||
1754610|NCT00279201|3224164|Superiority or Other||||||<|0.001||||||P-value is for Week 120.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.|||
1754611|NCT00279201|3224164|Superiority or Other||||||<|0.001||||||P-value is for Week 108.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.|||
1754612|NCT00279201|3224164|Superiority or Other||||||<|0.001||||||P-value is for Week 96.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.|||
1754613|NCT00279201|3224164|Superiority or Other||||||<|0.001||||||P-value is for Week 84.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.|||
1754614|NCT00279201|3224164|Superiority or Other||||||<|0.001||||||P-value is for Week 72.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.|||
1754615|NCT00279201|3224164|Superiority or Other||||||<|0.001||||||P-value is for Week 60.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.|||
1754616|NCT00279201|3224164|Superiority or Other||||||<|0.001||||||P-value is for Week 48.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.|||
1754617|NCT00279201|3224164|Superiority or Other||||||<|0.001||||||P-value is for Week 36.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.|||
1754618|NCT00279201|3224164|Superiority or Other||||||<|0.001||||||P-value is for Week 24.|ANOVA|Model: Treatment + Country + TZD use + sulfonylurea use.|||
1754619|NCT00279201|3224165|Superiority or Other||||||<|0.001||||||P-value is for Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.|||
1754620|NCT00279201|3224165|Superiority or Other||||||<|0.002||||||P-value is for Week 120.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.|||
1754621|NCT00279201|3224165|Superiority or Other||||||<|0.001||||||P-value is for Week 108.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.|||
1754622|NCT00279201|3224165|Superiority or Other||||||<|0.001||||||P-value is for Week 96.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.|||
1754623|NCT00279201|3224165|Superiority or Other||||||<|0.001||||||P-value is for Week 84.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.|||
1754624|NCT00279201|3224165|Superiority or Other||||||<|0.001||||||P-value is for Week 72.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.|||
1754625|NCT00279201|3224165|Superiority or Other||||||<|0.001||||||P-value is for Week 60.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.|||
1754626|NCT00279201|3224165|Superiority or Other||||||<|0.001||||||P-value is for Week 48.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.|||
1754627|NCT00279201|3224165|Superiority or Other||||||<|0.001||||||P-value is for Week 36.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.|||
1754628|NCT00279201|3224165|Superiority or Other||||||<|0.001||||||P-value is for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo Use.|||
1754629|NCT00279201|3224165|Superiority or Other||||||<|0.128||||||P-value is for Baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754630|NCT00279201|3224166|Superiority or Other||||||<|0.001||||||P-value is for Change from baseline at Endpoint.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754631|NCT00279201|3224166|Superiority or Other||||||<|0.002||||||P-value is for Change from baseline at Week 120.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754632|NCT00279201|3224166|Superiority or Other||||||<|0.001||||||P-value is for Change from baseline at Week 108|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754633|NCT00279201|3224166|Superiority or Other||||||<|0.001||||||P-value is for Change from baseline at Week 96.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754634|NCT00279201|3224166|Superiority or Other||||||<|0.001||||||P-value is for Change from baseline at Week 84.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754635|NCT00279201|3224166|Superiority or Other||||||<|0.001||||||P-value is for Change from baseline at Week 72.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754636|NCT00279201|3224166|Superiority or Other||||||<|0.001||||||P-value is for Change from baseline at Week 60.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754637|NCT00279201|3224166|Superiority or Other||||||<|0.001||||||P-value is for Change from baseline at Week 48.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754638|NCT00279201|3224166|Superiority or Other||||||<|0.001||||||P-value is for Change from baseline at Week 36.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754639|NCT00279201|3224166|Superiority or Other||||||<|0.001||||||P-value is for Change from baseline at Week 24.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754640|NCT00279201|3224167|Superiority or Other|||||||0.235||||||P-value is for <=6.5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754641|NCT00279201|3224167|Superiority or Other|||||||0.089||||||P-value is for <7.0%|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754642|NCT00279201|3224167|Superiority or Other|||||||0.134||||||P-value for <=7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754643|NCT00279201|3224168|Superiority or Other|||||||0.3|||||||ANCOVA|ANCOVA used with treatment, Baseline HbA1c, country, TZD use, and sulfo use in the model.|||
1754644|NCT00279201|3224169|Superiority or Other|||||||0.217||||||P-value is for Endpoint mean all blood glucose values.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754645|NCT00279201|3224169|Superiority or Other|||||||0.588||||||P-value is for Baseline mean all blood glucose values.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754646|NCT00279201|3224169|Superiority or Other||||||<|0.001||||||P-value is for Endpoint AM/PM 2hr postprandial excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754647|NCT00279201|3224169|Superiority or Other||||||<|0.281||||||P-value is for Baseline AM/PM 2hr postprandial excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754648|NCT00279201|3224169|Superiority or Other||||||<|0.002||||||P-value is for Endpoint combined AM/PM 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754649|NCT00279201|3224169|Superiority or Other||||||<|0.848||||||P-value is for Baseline combined AM/PM 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754650|NCT00279201|3224169|Superiority or Other||||||<|0.371||||||P-value is for Endpoint mean all premeal.|ANOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754651|NCT00279201|3224169|Superiority or Other||||||<|0.445||||||P-value is for Baseline mean all premeal.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754652|NCT00279201|3224169|Superiority or Other||||||<|0.019||||||P-value is for Endpoint mean of all 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754653|NCT00279201|3224169|Superiority or Other||||||<|0.956||||||P-value is for Baseline mean of all 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754654|NCT00279201|3224169|Superiority or Other||||||<|0.001||||||P-value is for Endpoint mean all meal time excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754655|NCT00279201|3224169|Superiority or Other||||||<|0.201||||||P-value is for Baseline mean all meal time excursions.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754656|NCT00279201|3224169|Superiority or Other||||||<|0.001||||||P-value is for Endpoint PM 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754657|NCT00279201|3224169|Superiority or Other||||||<|0.674||||||P-value is for Baseline PM 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754658|NCT00279201|3224169|Superiority or Other||||||<|0.161||||||P-value is for Endpoint midday 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754659|NCT00279201|3224169|Superiority or Other||||||<|0.589||||||P-value is for Baseline midday 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754660|NCT00279201|3224169|Superiority or Other||||||<|0.001||||||P-value is for Endpoint AM 2hr excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754661|NCT00279201|3224169|Superiority or Other||||||<|0.175||||||P-value is for Baseline AM 2hr excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754662|NCT00279201|3224169|Superiority or Other||||||<|0.234||||||P-value is for Endpoint 3AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754663|NCT00279201|3224169|Superiority or Other||||||<|0.164||||||P-value is for Baseline 3AM blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754664|NCT00279201|3224169|Superiority or Other||||||<|0.001||||||P-value is for Endpoint PM 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754665|NCT00279201|3224169|Superiority or Other||||||<|0.869||||||P-value is for Baseline PM 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754666|NCT00279201|3224169|Superiority or Other||||||<|0.517||||||P-value is for Endpoint PM pre-meal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754667|NCT00279201|3224169|Superiority or Other||||||<|0.535||||||P-value is for Baseline PM pre-meal blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754668|NCT00279201|3224169|Superiority or Other||||||<|0.51||||||P-value is for Endpoint midday 2hr postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754669|NCT00279201|3224169|Superiority or Other||||||<|0.792||||||P-value is for Baseline midday 2hr postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754670|NCT00279201|3224169|Superiority or Other||||||<|0.031||||||P-value is for Endpoint midday premeal blood.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754671|NCT00279201|3224169|Superiority or Other||||||<|0.867||||||P-value is for Baseline midday premeal blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754672|NCT00279201|3224169|Superiority or Other||||||<|0.138||||||P-value is for Endpoint AM 2-hour postprandial.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754673|NCT00279201|3224169|Superiority or Other||||||<|0.897||||||P-value is for Baseline AM 2-hour (hr) postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754674|NCT00279201|3224169|Superiority or Other||||||<|0.001||||||P-value is for Endpoint mean fasting blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD + Sulfo use.|||
1754675|NCT00279201|3224169|Superiority or Other||||||<|0.218||||||P-value for Baseline mean fasting blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754676|NCT00279201|3224170|Superiority or Other|||||||0.017||||||P-value is for Endpoint.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.|||
1754677|NCT00279201|3224170|Superiority or Other|||||||0.027||||||P-value is for Week 120.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.|||
1754678|NCT00279201|3224170|Superiority or Other|||||||0.047||||||P-value is for Week 108.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.|||
1754679|NCT00279201|3224170|Superiority or Other|||||||0.018||||||P-value for Week 96.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.|||
1754680|NCT00279201|3224170|Superiority or Other|||||||0.175||||||P-value is for Week 84.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.|||
1754681|NCT00279201|3224170|Superiority or Other|||||||0.779||||||P-value is for Week 72.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.|||
1754682|NCT00279201|3224170|Superiority or Other|||||||0.551||||||P-value for Week 60.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.|||
1754683|NCT00279201|3224170|Superiority or Other|||||||0.142||||||P-value for Week 48.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.|||
1754684|NCT00279201|3224170|Superiority or Other|||||||0.595||||||P-value is for Week 36.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.|||
1754685|NCT00279201|3224170|Superiority or Other|||||||0.657||||||P-value is for Week 24.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.|||
1754686|NCT00279201|3224170|Superiority or Other|||||||0.004||||||P-value is for Week 12.|ANCOVA|ANCOVA used with treatment, baseline HbA1c, country, TZD use, and sulfo use in the model.|||
1754687|NCT00279201|3224170|Superiority or Other|||||||0.204||||||P-value is for Week 0.|ANOVA|ANCOVA used with treatment, country, TZD use, and sulfo use in the model.|||
1754688|NCT00279201|3224171|Superiority or Other|||||||0.225||||||P-value is for Patients with 3 drugs (Sulfonylurea/TZD/Metformin).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.|||
1754689|NCT00279201|3224171|Superiority or Other|||||||0.969||||||P-value is for Sulfonylurea/TZD.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.|||
1754690|NCT00279201|3224171|Superiority or Other||||||<|0.001||||||P-value is for TZD/Metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.|||
1754691|NCT00279201|3224171|Superiority or Other||||||<|0.001||||||P-value is for Sulfonylurea/Metformin.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country only.|||
1754692|NCT00279201|3224172|Superiority or Other||||||<|0.001||||||P-value is for Fasting Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.|||
1754693|NCT00279201|3224172|Superiority or Other||||||<|0.001||||||P-value is for Average of All Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.|||
1754694|NCT00279201|3224172|Superiority or Other||||||<|0.001||||||P-value is for Post Meals Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.|||
1754695|NCT00279201|3224172|Superiority or Other||||||<|0.001||||||P-value is for Pre Meals Blood Glucose.|ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.|||
1754696|NCT00279201|3224173|Superiority or Other||||||<|0.001|||||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.|||
1754697|NCT00279201|3224174|Superiority or Other||||||<|0.001||||||P-value is overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and sulfo use.|||
1754698|NCT00279201|3224175|Superiority or Other||||||<|0.001|||||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use and Sulfo use in model.|||
1754699|NCT00279201|3224176|Superiority or Other||||||<|0.001|||||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.|||
1754700|NCT00279201|3224177|Superiority or Other||||||<|0.001||||||P-value is overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by country, TZD use, and Sulfo use.|||
1754701|NCT00279201|3224178|Superiority or Other||||||<|0.001|||||||ANOVA|ANOVA with met goal/did not meet goal, country, TZD use, and sulfo use in model.|||
1754702|NCT00279201|3224179|Superiority or Other||||||<|0.001||||||P-value is for Endpoint.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.|||
1754703|NCT00279201|3224179|Superiority or Other||||||<|0.001||||||P-value is for Week 24.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.|||
1754704|NCT00279201|3224179|Superiority or Other||||||<|0.001||||||P-value is for Week 18.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.|||
1754705|NCT00279201|3224179|Superiority or Other||||||<|0.001||||||P-value is for Week 12.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.|||
1754706|NCT00279201|3224179|Superiority or Other||||||<|0.001||||||P-value is for Week 10.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.|||
1754707|NCT00279201|3224179|Superiority or Other||||||<|0.001||||||P-value is for Week 8.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.|||
1754708|NCT00279201|3224179|Superiority or Other||||||<|0.001||||||P-value is for Week 6.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.|||
1754709|NCT00279201|3224179|Superiority or Other||||||<|0.001||||||P-value is for Week 5.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.|||
1754710|NCT00279201|3224179|Superiority or Other||||||<|0.001||||||P-value is for Week 4.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.|||
1754711|NCT00279201|3224179|Superiority or Other||||||<|0.001||||||P-value is for Week 3.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.|||
1758387|NCT00205777|3229639|Superiority or Other|||||||0.68|||||||ANOVA||||
1754712|NCT00279201|3224179|Superiority or Other||||||<|0.001||||||P-value is for Week 2.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.|||
1754713|NCT00279201|3224179|Superiority or Other||||||<|0.001||||||P-value is for Week 1.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in the model.|||
1754714|NCT00279201|3224180|Superiority or Other||||||<|0.001||||||P-value is for Hypoglycemia episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754715|NCT00279201|3224180|Superiority or Other||||||<|0.006||||||P-value is for Hypoglycemia episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754716|NCT00279201|3224180|Superiority or Other||||||<|0.167||||||P-value is for Severe episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754717|NCT00279201|3224180|Superiority or Other||||||<|0.165||||||P-value is for Severe episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754718|NCT00279201|3224180|Superiority or Other||||||<|0.42||||||P-value is for Nocturnal episodes Overall.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754719|NCT00279201|3224180|Superiority or Other||||||<|0.009||||||P-value is for Nocturnal episodes Endpoint.|ANOVA|Response = Treatment + Country + TZD use + Sulfo use.|||
1754720|NCT00279201|3224181|Superiority or Other|||||||0.08||||||P-value is for Severe hypoglycemic episodes overall. Initiation phase and maintenance phase are included.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754721|NCT00279201|3224181|Superiority or Other|||||||0.241||||||P-value is for Severe hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754722|NCT00279201|3224181|Superiority or Other|||||||0.585||||||P-value is for Nocturnal hypoglycemic episodes overall.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754723|NCT00279201|3224181|Superiority or Other|||||||0.834||||||P-value is for Nocturnal hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754724|NCT00279201|3224181|Superiority or Other|||||||0.037||||||P-value is for Overall hypoglycemic episodes.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754725|NCT00279201|3224181|Superiority or Other|||||||0.016||||||P-value is for Hypoglycemic episodes endpoint.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754726|NCT00279201|3224182|Superiority or Other||||||<|0.0001||||||P-value is for Actual weight at Endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.|||
1754727|NCT00279201|3224182|Superiority or Other||||||<|0.001||||||P-value is for Actual weight at Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.|||
1754728|NCT00279201|3224182|Superiority or Other||||||<|0.001||||||P-value is for Actual weight at Week 18.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.|||
1754729|NCT00279201|3224182|Superiority or Other||||||<|0.001||||||P-value for Actual weight at Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.|||
1754730|NCT00279201|3224182|Superiority or Other||||||<|0.001||||||P-value is for Actual weight at Week 6.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754731|NCT00279201|3224182|Superiority or Other||||||<|0.497||||||P-value for Actual weight at baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754732|NCT00279201|3224183|Superiority or Other||||||<|0.001||||||P-value for change from baseline at endpoint.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754733|NCT00279201|3224183|Superiority or Other||||||<|0.001||||||P-value for change from baseline at Week 24.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754734|NCT00279201|3224183|Superiority or Other||||||<|0.001||||||P-value for change from baseline at Week 18|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754735|NCT00279201|3224183|Superiority or Other||||||<|0.001||||||P-value for change from baseline at Week 12.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754736|NCT00279201|3224183|Superiority or Other||||||<|0.001||||||P-value for change from baseline at Week 6.|ANCOVA|Model: Response = Treatment + Baseline + Country + TZD use + sulfonylurea use.|||
1754737|NCT00279201|3224184|Superiority or Other|||||||0.003|||||||ANCOVA|ANCOVA model with treatment, baseline, country, TZD use, and sulfo use.|||
1754738|NCT00279201|3224185|Superiority or Other|||||||0.305||||||P-value is for Mean of all blood glucose values.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754739|NCT00279201|3224185|Superiority or Other|||||||0.464||||||P-value is for Baseline mean of all BG values.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754740|NCT00279201|3224185|Superiority or Other||||||<|0.001||||||P-value is for AM/PM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754741|NCT00279201|3224185|Superiority or Other||||||<|0.165||||||P-value is for Baseline AM/PM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754742|NCT00279201|3224185|Superiority or Other||||||<|0.055||||||P-value is for Mean of all premeal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754743|NCT00279201|3224185|Superiority or Other||||||<|0.364||||||P-value is for Baseline mean all premeal BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754744|NCT00279201|3224185|Superiority or Other||||||<|0.001||||||P-value is for AM/PM 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754745|NCT00279201|3224185|Superiority or Other||||||<|0.677||||||P-value is for Baseline AM/PM 2-hour postprandial BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754746|NCT00279201|3224185|Superiority or Other||||||<|0.001||||||P-value is for Mean of all 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754747|NCT00279201|3224185|Superiority or Other||||||<|0.628||||||P-value is for Baseline mean all 2hour PP BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1758388|NCT00205777|3229640|Superiority or Other|||||||0.18|||||||ANOVA||||
1754748|NCT00279201|3224185|Superiority or Other||||||<|0.001||||||P-value is for Mean of all meal time excursions.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754749|NCT00279201|3224185|Superiority or Other||||||<|0.436||||||P-value is for Baseline mean all meal time excursions.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754750|NCT00279201|3224185|Superiority or Other||||||<|0.001||||||P-value is for PM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754751|NCT00279201|3224185|Superiority or Other||||||<|0.994||||||P-value is for Baseline PM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754752|NCT00279201|3224185|Superiority or Other||||||<|0.005||||||P-value is for Midday 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754753|NCT00279201|3224185|Superiority or Other||||||<|0.567||||||P-value is for Baseline midday 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754754|NCT00279201|3224185|Superiority or Other||||||<|0.001||||||P-value is for AM 2-hour blood glucose excursion.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754755|NCT00279201|3224185|Superiority or Other||||||<|0.021||||||P-value is for Baseline AM 2-hour BG excursion.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754756|NCT00279201|3224185|Superiority or Other||||||<|0.693||||||P-value is for 3 AM blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754757|NCT00279201|3224185|Superiority or Other||||||<|0.199||||||P-value is for Baseline 3 AM blood glucose.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754758|NCT00279201|3224185|Superiority or Other||||||<|0.001||||||P-value Evening 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754759|NCT00279201|3224185|Superiority or Other||||||<|0.297||||||P-value is for Baseline evening 2hour postprandial.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754760|NCT00279201|3224185|Superiority or Other||||||<|0.161||||||P-value for Evening pre-meal blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754761|NCT00279201|3224185|Superiority or Other||||||<|0.321||||||P-value is for Baseline evening pre-meal BG.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754762|NCT00279201|3224185|Superiority or Other||||||<|0.514||||||P-value Midday 2-hour postprandial BG.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754763|NCT00279201|3224185|Superiority or Other||||||<|0.759||||||P-value is for Baseline midday 2-hour postprandial BG|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.|||
1754764|NCT00279201|3224185|Superiority or Other||||||<|0.001||||||P-value for Midday premeal blood glucose (BG).|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754765|NCT00279201|3224185|Superiority or Other||||||<|0.971||||||P-value is for Baseline midday premeal BG.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.|||
1754766|NCT00279201|3224185|Superiority or Other||||||<|0.016||||||P-value for AM 2-hour postprandial blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754767|NCT00279201|3224185|Superiority or Other||||||<|0.7||||||P-value is for Baseline AM 2-hour postprandial BG.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.|||
1754768|NCT00279201|3224185|Superiority or Other||||||<|0.001||||||P-value is for mean fasting blood glucose.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754769|NCT00279201|3224185|Superiority or Other||||||<|0.179||||||P-value is for Baseline mean fasting blood glucose.|ANOVA|ANOVA with treatment, country, TZD use and sulfo use in model.|||
1754770|NCT00279201|3224186|Superiority or Other|||||||0.005||||||P-value for endpoint.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754771|NCT00279201|3224186|Superiority or Other|||||||0.003||||||P-value for Week 24.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754772|NCT00279201|3224186|Superiority or Other||||||<|0.001||||||P-value for Week 12.|ANCOVA|Response = Treatment + Baseline + Country + TZD use + sulfo use.|||
1754773|NCT00279201|3224186|Superiority or Other||||||<|0.416||||||P-value for baseline.|ANOVA|ANOVA with treatment, country, TZD use, and sulfo use in model.|||
1754774|NCT00279201|3224187|Superiority or Other|||||||0.174||||||P-value is for <=6.5%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754775|NCT00279201|3224187|Superiority or Other||||||<|0.001||||||P-value is for <7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754776|NCT00279201|3224187|Superiority or Other||||||<|0.002||||||P-value for <=7.0%.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic controlling for country, TZD use, and sulfo use.|||
1754777|NCT00279201|3224188|Superiority or Other|||||||0.005|||||||ANCOVA|Response = Treatment + Baseline + Country + TZD use + Sulfo use.|||
1754778|NCT00279201|3224189|Superiority or Other|||||||0.99|||||||ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754779|NCT00279201|3224189|Superiority or Other|||||||0.271|||||||ANCOVA|Response = Treatment + Baseline + Country + TZD use.|||
1754780|NCT00279201|3224190|Superiority or Other|||||||0.04|||||||Log Rank|Stratified by country, thiazolidinedione (TZD) use, sulfo use.|||
1754781|NCT00279201|3224191|Superiority or Other|||||||0.005|||||||ANCOVA|P-value from ANCOVA, baseline value as covariate. Response = Treatment + Baseline + Country + thiazolidinedione (TZD) use + Sulfonylurea (sulfo) use.|||
1754782|NCT00278954|3224201|Superiority or Other||SABI per subject per year|0.0||||0.01||99.0|0.0|0.101|||Poisson regression with log link||Mean SABI rate = 0 per subject per year. 1-sided 99% upper confidence bound could not be calculated.|The estimated serious acute bacterial infection (SABI) rate was calculated by dividing no. of infections by no.of subject years. The exponential of the upper limit of the 98% 2-sided Confidence Interval (CI) gave the upper, 1-sided, 99% confidence bound, estimated using Poisson regression. The equivalent upper bound per subject year was obtained by dividing this figure by total subject years.|
1754783|NCT00277446|3224283|Superiority or Other|||||||0.88|||||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."|
1754784|NCT00277446|3224284|Superiority or Other|||||||0.02|||||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."|
1754785|NCT00277446|3224285|Superiority or Other||||||<|0.03|||||||t-test, 2 sided|||"The two groups tested were baseline and after 4 weeks of treatment with the soy isoflavone supplement."|
1754786|NCT00277212|3224291|Superiority or Other||Mean Difference (Final Values)|0.17||||0.021|2-Sided|95.0|0.03|0.31||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from Baseline|
1754787|NCT00277212|3224291|Superiority or Other||Mean Difference (Final Values)|0.05||||0.358|2-Sided|95.0|-0.06|0.17||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 52 (LOCF)|
1754788|NCT00277212|3224291|Superiority or Other||Mean Difference (Final Values)|0.03|||||2-Sided|95.0|-0.08|0.14|||||aripiprazole - placebo|Change from baseline at Week 52|
1754789|NCT00277212|3224291|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-0.13|0.13|||||aripiprazole - placebo|Change from baseline at Week 36|
1754790|NCT00277212|3224291|Superiority or Other||Mean Difference (Final Values)|0.03|||||2-Sided|95.0|-0.11|0.17|||||aripiprazole - placebo|Change from Baseline at Week 24|
1754791|NCT00277212|3224291|Superiority or Other||Mean Difference (Final Values)|0.17|||||2-Sided|95.0|0.04|0.3|||||aripiprazole - placebo|Change from Baseline at Week 8|
1754792|NCT00277212|3224291|Superiority or Other||Mean Difference (Final Values)|0.06||||0.435|2-Sided|95.0|-0.08|0.2||Means, mean differences, 95% confidence intervals for the differences, and the p-values are based on ANOVA/ANCOVA model.|ANOVA|ANOVA, controlling for treatment, used for baseline estimates.|aripiprazole - placebo|Baseline|
1754793|NCT00277212|3224292|Superiority or Other||Mean Difference (Final Values)|0.03||||0.73|2-Sided|95.0|-0.16|0.23||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from Baseline|
1754794|NCT00277212|3224292|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.515|2-Sided|95.0|-0.22|0.11||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52 (LOCF)|
1754795|NCT00277212|3224292|Superiority or Other||Mean Difference (Final Values)|0.06|||||2-Sided|95.0|-0.05|0.16|||||aripiprazole - placebo|Change from Baseline at week 52|
1754796|NCT00277212|3224292|Superiority or Other||Mean Difference (Final Values)|0.21|||||2-Sided|95.0|0.0|0.42|||||aripiprazole - placebo|Change from Baseline at Week 36|
1754797|NCT00277212|3224292|Superiority or Other||Mean Difference (Final Values)|0.04|||||2-Sided|95.0|-0.11|0.2|||||aripiprazole - placebo|Change from baseline at Week 24|
1754798|NCT00277212|3224292|Superiority or Other||Mean Difference (Final Values)|0.11|||||2-Sided|95.0|-0.05|0.26|||||aripiprazole - placebo|Change from Baseline at Week 8|
1754799|NCT00277212|3224292|Superiority or Other||Mean Difference (Final Values)|-0.07||||0.458||95.0|-0.25|0.11||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANOVA|ANOVA model, controlling for treatment, is used for baseline estimates.|aripiprazole - placebo|Baseline|
1754800|NCT00277212|3224293|Superiority or Other||Mean Difference (Final Values)|0.31||||0.061|2-Sided|95.0|-0.01|0.63||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripirazole - placebo|Highest change from Baseline|
1754801|NCT00277212|3224293|Superiority or Other||Mean Difference (Final Values)|0.24||||0.095|2-Sided|95.0|-0.04|0.52||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariate=baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from Baseline at Week 52 (LOCF)|
1754802|NCT00277212|3224293|Superiority or Other||Mean Difference (Final Values)|0.29|||||2-Sided|95.0|-0.06|0.65|||||aripiprazole - placebo|Change from baseline at Week 52|
1754803|NCT00277212|3224293|Superiority or Other||Mean Difference (Final Values)|0.25|||||2-Sided|95.0|-0.06|0.55|||||aripiprazole - placebo|Change from Baseline at Week 36|
1754804|NCT00277212|3224293|Superiority or Other||Mean Difference (Final Values)|0.24|||||2-Sided|95.0|-0.13|0.6|||||aripiprazole - placebo|Change from baseline at Week 24|
1754805|NCT00277212|3224293|Superiority or Other||Mean Difference (Final Values)|0.24|||||2-Sided|95.0|-0.03|0.51|||||aripiprazole - placebo|Change from baseline at Week 8|
1754806|NCT00277212|3224293|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.971|2-Sided|95.0|-0.35|0.34||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANOVA|ANOVA model, with double-blind treatment as main effects, is used for Baseline comparisons.|aripiprazole - placebo|Baseline|
1754807|NCT00277212|3224299|Superiority or Other||Mean Difference (Final Values)|0.63||||0.002|2-Sided|95.0|0.23|1.04||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode & baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Highest Change from baseline|
1754835|NCT00276484|3224327|Superiority or Other||Mean Difference (Final Values)|-16.3|Standard Error of the Mean|1.6|<|0.001||95.0|-19.4|-13.2|||ANCOVA|Model terms: treatment and baseline LDL-C value|||
1754808|NCT00277212|3224299|Superiority or Other||Mean Difference (Final Values)|0.79||||0.001|2-Sided|95.0|0.31|1.26||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA (main effects=double-blind treatment, covariates=index mood episode & baseline assessment) used for mean change from baseline comparisons.|aripiprazole - placebo|Change from baseline at Week 52 (LOCF)|
1754809|NCT00277212|3224299|Superiority or Other||Mean Difference (Final Values)|0.92|||||2-Sided|95.0|-0.08|1.92|||||aripiprazole - placebo|Change from baseline at Week 52|
1754810|NCT00277212|3224299|Superiority or Other||Mean Difference (Final Values)|0.97|||||2-Sided|95.0|0.08|1.86|||||aripiprazole - placebo|Change from baseline at Week 36|
1754811|NCT00277212|3224299|Superiority or Other||Mean Difference (Final Values)|0.75|||||2-Sided|95.0|0.19|1.3|||||aripiprazole - placebo|Change from baseline at Week 24|
1754812|NCT00277212|3224299|Superiority or Other||Mean Difference (Final Values)|0.36|||||2-Sided|95.0|-0.06|0.78|||||aripiprazole - placebo|Change from Baseline at Week 12|
1754813|NCT00277212|3224299|Superiority or Other||Mean Difference (Final Values)|-0.64||||0.467|2-Sided|95.0|-2.37|1.09||Means, treatment differences between aripiprazole and placebo, 95% confidence intervals for the differences and the p-values for treatment comparisons are based on ANOVA/ANCOVA model.|ANCOVA|ANCOVA model, with double-blind treatment as main effects and index mood episode as covariate, is used for Baseline comparisons.|aripiprazole - placebo|Baseline|
1754814|NCT00277212|3224300|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel||||
1754815|NCT00277212|3224300|Superiority or Other||relative risk|3.41||||0.007|2-Sided|95.0|1.3|8.94|||Cochran-Mantel-Haenszel|||Week 52 LOCF|
1754816|NCT00277212|3224301|Superiority or Other|||||||0.194|||||||Cochran-Mantel-Haenszel|||At Any Time|
1754817|NCT00277212|3224301|Superiority or Other||Risk Ratio (RR)|0.56||||0.073|2-Sided|95.0|0.29|1.07|||Cochran-Mantel-Haenszel||aripiprazole/placebo|Week 52 LOCF|
1754818|NCT00277212|3224302|Superiority or Other||Treatement Difference|2.24||||0.001|2-Sided|95.0|0.91|3.57||ANOVA (main effects=double-blind treatment, covariate=index mood episode) used for baseline comparisons. ANCOVA (main effects=double-blind treatment, covariates=index mood episode & baseline assessment) used for mean change from baseline comparisons|ANCOVA||Aripiprazole vs. placebo|Week 52 LOCF|
1754819|NCT00277212|3224304|Superiority or Other||Hazard Ratio (HR)|0.871||||0.295|2-Sided|95.0|0.672|1.128||p-value for equality of survival curves|Log Rank|stratified Log-Rank Test, controlling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.||
1754820|NCT00277212|3224305|Superiority or Other||Hazard Ratio (HR)|0.784||||0.381|2-Sided|95.0|0.454|1.354||p-value for equality of survival curves|Log Rank|stratified log-rank test, conrolling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.||
1754821|NCT00277212|3224306|Superiority or Other||Hazard Ratio (HR)|0.671||||0.055|2-Sided|95.0|0.446|1.011||p-value for equality of survival curves|Log Rank|stratified log-rank test, controlling for type of index mood episode|aripiprazole/placebo; Cox's proportional hazards model, with type of index mood episode as stratification facto, and randomized treatment group as covariate.||
1754822|NCT00277212|3224307|Superiority or Other||Cox Proportional Hazard|0.552||||0.058|2-Sided|95.0|0.296|1.03||stratified Log-Rank test, controlling for type of index mood episode|Log Rank||Cox's proportional hazards model, with type of index modd episode as stratification factor, and randomized treatment group as covariate.||
1754823|NCT00276484|3224315|Superiority or Other||Odds Ratio (OR)|8.37|||<|0.001||95.0|5.45|12.84|||Regression, Logistic|Model terms: treatment and baseline LDL-C value|||
1754824|NCT00276484|3224316|Superiority or Other||Mean Difference (Final Values)|-6.8||||0.174||95.0|-17.1|3.4|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment.|Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.||
1754825|NCT00276484|3224317|Superiority or Other||Mean Difference (Final Values)|-14.5|Standard Error of the Mean|-1.6|<|0.001||95.0|-17.7|-11.3|||ANCOVA|Model terms: treatment and baseline non-HDL-C:HDL-C value|||
1754826|NCT00276484|3224318|Superiority or Other||Mean Difference (Final Values)|-11.0|Standard Error of the Mean|1.4|<|0.001||95.0|-13.8|-8.2|||ANCOVA|Model terms: treatment and baseline Apo B:Apo A-I value|||
1754827|NCT00276484|3224319|Superiority or Other||Mean Difference (Final Values)|-16.5|Standard Error of the Mean|1.7|<|0.001||95.0|-19.9|-13.1|||ANCOVA|Model terms: treatment and baseline LDL-C:HDL-C value|||
1754828|NCT00276484|3224320|Superiority or Other||Mean Difference (Final Values)|-10.4|Standard Error of the Mean|1.1|<|0.001||95.0|-12.6|-8.2|||ANCOVA|Model terms: treatment and baseline Total-C:HDL-C value|||
1754829|NCT00276484|3224321|Superiority or Other||Mean Difference (Final Values)|0.9|Standard Error of the Mean|0.8||0.313||95.0|-0.8|2.5|||ANCOVA|Model terms: treatment and baseline Apo A-I value|||
1754830|NCT00276484|3224322|Superiority or Other||Mean Difference (Final Values)|-10.1|Standard Error of the Mean|1.3|<|0.001||95.0|-12.7|-7.6|||ANCOVA|Model terms: treatment and baseline Apo B value|||
1754831|NCT00276484|3224323|Superiority or Other||Median Difference (Final Values)|-7.3|||<|0.001||95.0|-11.5|-3.1|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.|The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon’s rank sum test statistic.||
1754832|NCT00276484|3224324|Superiority or Other||Mean Difference (Final Values)|-10.0|Standard Error of the Mean|1.0|<|0.001||95.0|-12.0|-7.9|||ANCOVA|Model terms: treatment and baseline Total-C value|||
1754833|NCT00276484|3224325|Superiority or Other||Mean Difference (Final Values)|-14.3|Standard Error of the Mean|1.4|<|0.001||95.0|-17.1|-11.6|||ANCOVA|Model terms: treatment and baseline non-HDL-C value|||
1754834|NCT00276484|3224326|Superiority or Other||Mean Difference (Final Values)|0.5|Standard Error of the Mean|0.8||0.551||95.0|-1.1|2.1|||ANCOVA|Model terms: treatment and baseline HDL-C value|||
1754958|NCT00274456|3224487|Superiority or Other (legacy)||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR|
1754836|NCT00276458|3224328|Superiority or Other||Odds Ratio (OR)|8.6|||<|0.001||95.0|3.8|19.47|||Regression, Logistic|Model terms: treatment and baseline LDL-C value|Estimated ratio is the predictive odds of attaining LDL-C target on Atorva + EZ versus Atorva.||
1754837|NCT00276458|3224329|Superiority or Other||Mean Difference (Final Values)|-8.3||||0.839||95.0|-26.1|8.3|||Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline CRP value|"The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon’s rank sum test statistic.~(Atorva + EZ minus Atorva)"||
1754838|NCT00276458|3224330|Superiority or Other||Mean Difference (Final Values)|2.5||||0.841||95.0|-23.8|28.8|||Longitudinal Data Analysis (LDA)|LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment|"Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.~(Atorva + EZ minus Atorva)"||
1754839|NCT00276458|3224331|Superiority or Other||Mean Difference (Final Values)|-17.3|Standard Error of the Mean|3.0|<|0.001||95.0|-23.2|-11.4|||ANCOVA|Model terms: treatment and baseline non-HDL-C:HDL-C value|(Atorva + EZ minus Atorva)||
1754840|NCT00276458|3224332|Superiority or Other||Mean Difference (Final Values)|-13.1|Standard Error of the Mean|2.4|<|0.001||95.0|-17.9|-8.3|||ANCOVA|Model terms: treatment and baseline Apo B:Apo A-I value|(Atorva + EZ minus Atorva)||
1754841|NCT00276458|3224333|Superiority or Other||Mean Difference (Final Values)|-20.9|Standard Error of the Mean|2.8|<|0.001||95.0|-26.5|-15.3|||ANCOVA|Model terms: treatment and baseline LDL-C:HDL-C value|(Atorva + EZ minus Atorva)||
1754842|NCT00276458|3224334|Superiority or Other||Mean Difference (Final Values)|-13.1|Standard Error of the Mean|2.2|<|0.001||95.0|-17.5|-8.7|||ANCOVA|Model terms: treatment and baseline Total-C:HDL-C value|(Atorva + EZ minus Atorva)||
1754843|NCT00276458|3224335|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|1.6||0.681||95.0|-3.9|2.6|||ANCOVA|Model terms: treatment and baseline Apo A-I value|(Atorva + EZ minus Atorva)||
1754844|NCT00276458|3224336|Superiority or Other||Mean Difference (Final Values)|-13.7|Standard Error of the Mean|2.1|<|0.001||95.0|-17.8|-9.6|||ANCOVA|Model terms: treatment and baseline Apo B value|(Atorva + EZ minus Atorva)||
1754845|NCT00276458|3224337|Superiority or Other||Median Difference (Final Values)|-8.9||||0.159||95.0|-17.7|-0.4||ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value|Nonparametric ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.|"The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon’s rank sum test statistic.~(Atorva + EZ minus Atorva)"||
1754846|NCT00276458|3224338|Superiority or Other||Mean Difference (Final Values)|-12.2|Standard Error of the Mean|1.8|<|0.001||95.0|-15.8|-8.6|||ANCOVA|Model terms: treatment and baseline Total-C value|(Atorva + EZ minus Atorva)||
1754847|NCT00276458|3224339|Superiority or Other||Mean Difference (Final Values)|-16.4|Standard Error of the Mean|2.4|<|0.001||95.0|-21.2|-11.7|||ANCOVA|Model terms: treatment and baseline non-HDL-C value|(Atorva + EZ minus Atorva)||
1754848|NCT00276458|3224340|Superiority or Other||Mean Difference (Final Values)|2.4|Standard Error of the Mean|2.1||0.273||95.0|-1.9|6.6|||ANCOVA|Model terms: treatment and baseline HDL-C value|(Atorva + EZ minus Atorva)||
1754849|NCT00276458|3224341|Superiority or Other||Mean Difference (Final Values)|-19.9|Standard Error of the Mean|2.7|<|0.001||95.0|-25.2|-14.5|||ANCOVA|Model terms: treatment and baseline LDL-C value|(Atorva + EZ minus Atorva)||
1754850|NCT00276406|3224349|Superiority or Other||||||<|0.04|||||||ANCOVA|||Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.|
1754851|NCT00276406|3224350|Superiority or Other|||||||0.005|||||||ANCOVA|||Bowel diaries were analyzed by computing the mean scores for the 9-day baseline period and separately for the last 7 days of the treatment period (i.e., when the pyridostigmine dose was stable in each subject.) Individual subject treatment period mean bowel function scores were then compared using a similar ANCOVA model, with the corresponding individual subject baseline mean bowel function score and gender as covariates.|
1754852|NCT00276406|3224351|Superiority or Other|||||||0.02|||||||ANCOVA||||
1754853|NCT00276406|3224352|Superiority or Other|||||||0.096|||||||ANCOVA|||Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.|
1754854|NCT00276406|3224356|Superiority or Other||||||<|0.01|||||||ANCOVA|||Analysis was adjusted for BMI and baseline values and incorporated Bonferroni corrections.|
1754855|NCT00276380|3224358|Other|||||||0.828||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates|ANCOVA|||Comparison of treatment effect at Day 168|
1754856|NCT00276380|3224358|Other|||||||0.338||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84|
1754857|NCT00276380|3224358|Other|||||||0.623||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28|
1754858|NCT00276380|3224359|Other|||||||0.645||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 168|
1754859|NCT00276380|3224359|Other|||||||0.441||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84|
1754860|NCT00276380|3224359|Other|||||||0.24||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28|
1754861|NCT00276380|3224360|Other|Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.||||||0.814|||||||ANCOVA|||Comparison of treatment effect at Day 168|
1754862|NCT00276380|3224360|Other|||||||0.59||||||Treatment effect was derived using an ANCOVA analysis with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 84|
1754863|NCT00276380|3224360|Other|||||||0.207||||||Treatment effect was derived using a parametric analysis of covariance (ANCOVA) with baseline and pooled centres as covariates.|ANCOVA|||Comparison of treatment effect at Day 28|
1754864|NCT00276380|3224362|Other|Comparison of treatment effect at Day 84|Odds Ratio (OR)|0.74||||0.3|2-Sided|95.0|0.42|1.3|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.|
1754865|NCT00276380|3224362|Other|Comparison of treatment effect at Day 28|Odds Ratio (OR)|0.86||||0.623|2-Sided|95.0|0.47|1.57|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.|
1754866|NCT00276380|3224363|Other||Odds Ratio (OR)|0.83||||0.52|2-Sided|95.0|0.46|1.48|||Cochran-Mantel-Haenszel||The homogeneity of the Odds Ratio (OR) across centres was assessed by the Breslow Day test.|The association between treatment and response after adjustment for the pooled centres was analysed using a Cochran-Mantel-Haenszel test.|
1754867|NCT00276016|3224391|Superiority or Other||||||<|0.001|||||||ANOVA|||For endpoint|
1754868|NCT00276016|3224392|Superiority or Other|||||||0.561|||||||ANOVA|||For endpoint|
1754869|NCT00275561|3224405|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1754870|NCT00275561|3224406|Superiority or Other|||||||0.49|||||||Fisher Exact||||
1754871|NCT00275561|3224407|Superiority or Other|||||||0.74|||||||Fisher Exact||||
1754872|NCT00275392|3224411|Superiority or Other||||||>|0.05||||||Main effect of Group|RM ANOVA||||
1754873|NCT00275392|3224411|Superiority or Other||||||>|0.016||||||main effect of time|RM ANOVA||||
1754874|NCT00275392|3224411|Superiority or Other||||||>|0.05||||||Interaction effect|RM ANOVA||||
1754875|NCT00275392|3224412|Superiority or Other||||||>|0.05||||||main effect of group|RM ANOVA||||
1754876|NCT00275392|3224412|Superiority or Other||||||<|0.001||||||main effect of time|RM ANOVA||||
1754877|NCT00275392|3224412|Superiority or Other||||||<|0.026||||||Interaction effect|RM ANOVA||||
1754878|NCT00275340|3224417|Non-Inferiority or Equivalence|Study was not powered to determine significant group differences; thus trends are reported for p<0.20.|||||p<|0|||||||t-test, 2 sided|||Mean change scores were computed on domain and summary scores. Mean differences in change scores between groups were computed and t-tests used to detect significant differences.|
1754879|NCT00275301|3224418|Superiority or Other||||||<|0.05|||||||Regression, Linear|||Examination of relationship between Borderline Personality Disorder symptoms and brain metabolism at baseline.|
1754880|NCT00275262|3224423|Superiority or Other|||||||0.299|||||||ANOVA|The statistical method used for a 1-way ANOVA between treatment groups.||The final on treatment values were included in the analysis.|
1754881|NCT00275262|3224424|Superiority or Other|||||||0.125|||||||ANOVA|The statistical method used for a 1-way ANOVA between treatment groups.||The final on treatment values were included in the analysis.|
1754882|NCT00274716|3224460|Superiority or Other||Mean Difference (Final Values)|-7.6|Standard Error of the Mean|9.2||0.409|2-Sided|95.0|-25.9|10.6|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable|||
1754883|NCT00274716|3224460|Superiority or Other||Median Difference (Final Values)|2.6|Standard Error of the Mean|9.0||0.772|2-Sided|95.0|-15.2|20.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable|||
1754884|NCT00274716|3224460|Superiority or Other||Mean Difference (Final Values)|2.3|Standard Error of the Mean|9.2||0.802|2-Sided|95.0|-15.8|20.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable|||
1754885|NCT00274716|3224460|Superiority or Other||Mean Difference (Final Values)|-5.3|Standard Error of the Mean|9.2||0.562|2-Sided|95.0|-23.5|12.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable|||
1754886|NCT00274716|3224460|Superiority or Other||Mean Difference (Final Values)|4.9|Standard Error of the Mean|9.0||0.587|2-Sided|95.0|-12.9|22.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline TG as a continuous variable|||
1754887|NCT00274716|3224461|Superiority or Other||Mean Difference (Final Values)|-6.1|Standard Error of the Mean|2.5||0.018|2-Sided|95.0|-11.1|-1.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable|||
1754888|NCT00274716|3224461|Superiority or Other||Mean Difference (Final Values)|-8.3|Standard Error of the Mean|2.5||0.001|2-Sided|95.0|-13.3|-3.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable|||
1754889|NCT00274716|3224461|Superiority or Other||Mean Difference (Final Values)|2.1|Standard Error of the Mean|2.6||0.429|2-Sided|95.0|-3.1|7.2|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable|||
1754890|NCT00274716|3224461|Superiority or Other||Mean Difference (Final Values)|-4.0|Standard Error of the Mean|2.6||0.124|2-Sided|95.0|-9.2|1.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable|||
1754891|NCT00274716|3224461|Superiority or Other||Mean Difference (Final Values)|-6.3|Standard Error of the Mean|2.5||0.015|2-Sided|95.0|-11.3|-1.2|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline HDL-C as a continuous variable|||
1754892|NCT00274716|3224462|Superiority or Other||Mean Difference (Final Values)|-3.6|Standard Error of the Mean|4.4||0.418|2-Sided|95.0|-12.2|5.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable|||
1754959|NCT00274456|3224487|Superiority or Other (legacy)||||||>|0.005|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR|
1758389|NCT00205777|3229640|Superiority or Other|||||||0.41|||||||ANOVA||||
1754893|NCT00274716|3224462|Superiority or Other||Mean Difference (Final Values)|-7.8|Standard Error of the Mean|4.4||0.077|2-Sided|95.0|-16.4|0.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable|||
1754894|NCT00274716|3224462|Superiority or Other||Mean Difference (Final Values)|-4.5|Standard Error of the Mean|4.5||0.319|2-Sided|95.0|-13.4|4.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable|||
1754895|NCT00274716|3224462|Superiority or Other||Mean Difference (Final Values)|-8.1|Standard Error of the Mean|4.4||0.066|2-Sided|95.0|-16.7|0.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable|||
1754896|NCT00274716|3224462|Superiority or Other||Mean Difference (Final Values)|-12.3|Standard Error of the Mean|4.3||0.005|2-Sided|95.0|-20.8|-3.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline LDL-C as a continuous variable|||
1754897|NCT00274716|3224463|Superiority or Other||Mean Difference (Final Values)|-2.2|Standard Error of the Mean|0.9||0.022|2-Sided|95.0|-4.0|-0.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable|||
1754898|NCT00274716|3224463|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.9||0.686|2-Sided|95.0|-2.2|1.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable|||
1754899|NCT00274716|3224463|Superiority or Other||Mean Difference (Final Values)|-1.4|Standard Error of the Mean|0.9||0.136|2-Sided|95.0|-3.3|0.5|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable|||
1754900|NCT00274716|3224463|Superiority or Other||Mean Difference (Final Values)|-3.6|Standard Error of the Mean|1.0|<|0.001|2-Sided|95.0|-5.5|-1.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable|||
1754901|NCT00274716|3224463|Superiority or Other||Mean Difference (Final Values)|-1.8|Standard Error of the Mean|0.9|<|0.059|2-Sided|95.0|-3.7|0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline waist as a continuous variable|||
1754902|NCT00274716|3224464|Superiority or Other||Mean Difference (Final Values)|0.6|Standard Error of the Mean|0.4||0.118|2-Sided|95.0|-0.2|1.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable|||
1754903|NCT00274716|3224464|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.4||0.462|2-Sided|95.0|-0.5|1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable|||
1754904|NCT00274716|3224464|Superiority or Other||Mean Difference (Final Values)|-1.7|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-2.4|-1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable|||
1754905|NCT00274716|3224464|Superiority or Other||Mean Difference (Final Values)|-1.1|Standard Error of the Mean|0.4|<|0.003|2-Sided|95.0|-1.9|-0.4|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable|||
1754906|NCT00274716|3224464|Superiority or Other||Median Difference (Final Values)|-1.4|Standard Error of the Mean|0.4|<|0.001|2-Sided|95.0|-2.2|-0.7|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline weight as a continuous variable|||
1754907|NCT00274716|3224465|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|2.5||0.941|2-Sided|95.0|-4.7|5.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable|||
1754908|NCT00274716|3224465|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|2.5||0.752|2-Sided|95.0|-5.7|4.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable|||
1754909|NCT00274716|3224465|Superiority or Other||Mean Difference (Final Values)|-4.1|Standard Error of the Mean|2.5||0.099|2-Sided|95.0|-9.0|0.8|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable|||
1754910|NCT00274716|3224465|Superiority or Other||Mean Difference (Final Values)|-3.9|Standard Error of the Mean|2.4||0.108|2-Sided|95.0|-8.7|0.9|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable|||
1754911|NCT00274716|3224465|Superiority or Other||Median Difference (Final Values)|-4.9|Standard Error of the Mean|2.4||0.046|2-Sided|95.0|-9.7|-0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable|||
1754912|NCT00274716|3224466|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|1.6||0.602|2-Sided|95.0|-3.9|2.3|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable|||
1754913|NCT00274716|3224466|Superiority or Other||Mean Difference (Final Values)|1.0|Standard Error of the Mean|1.6||0.517|2-Sided|95.0|-2.1|4.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable|||
1754914|NCT00274716|3224466|Superiority or Other||Mean Difference (Final Values)|-3.2|Standard Error of the Mean|1.6||0.042|2-Sided|95.0|-6.4|-0.1|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable|||
1754915|NCT00274716|3224466|Superiority or Other||Mean Difference (Final Values)|-4.1|Standard Error of the Mean|1.5||0.01|2-Sided|95.0|-7.1|-1.0|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable|||
1758390|NCT00205777|3229641|Superiority or Other|||||||0.16|||||||ANOVA||||
1754916|NCT00274716|3224466|Superiority or Other||Mean Difference (Final Values)|-2.2|Standard Error of the Mean|1.6||0.157|2-Sided|95.0|-5.3|0.9|||ANCOVA|Treatment group and ambulatory blood pressure measurement (ABPM; yes or no) as class variables and baseline mean trough SiDBP as a continuous variable|||
1754917|NCT00274625|3224473|Superiority or Other|||||||0.6|||||||Fisher Exact||||
1754918|NCT00274469|3224474|Superiority||Hazard Ratio (HR)|0.76||||0.126|2-Sided|95.0|0.54|1.08|||Regression, Cox|Cox regression analysis of OS controlling for baseline covariates|HR<1 favours Fulvestrant||
1754919|NCT00274469|3224474|Superiority||Hazard Ratio (HR)|0.7||||0.041|2-Sided|95.0|0.5|0.98|||Log Rank||||
1754920|NCT00274469|3224475|Superiority||Hazard Ratio (HR)|0.64||||0.01|2-Sided|95.0|0.46|0.9|||Regression, Cox|Cox regression analysis of TTP (investigator assessed) controlling for baseline covariates.|HR<1 favours Fulvestrant||
1754921|NCT00274469|3224475|Superiority||Hazard Ratio (HR)|0.66||||0.01|2-Sided|95.0|0.47|0.92|||Log Rank||HR<1 favours Fulvestrant||
1754922|NCT00274469|3224476|Superiority||Hazard Ratio (HR)|0.72||||0.04|2-Sided|95.0|0.52|0.98|||Regression, Cox|Cox regression analysis of TTTF controlling for baseline covariates.|HR<1 favours Fulvestrant||
1754923|NCT00274469|3224476|Superiority||Hazard Ratio (HR)|0.73||||0.05|2-Sided|95.0|0.54|1.0|||Log Rank||HR<1 favours Fulvestrant||
1754924|NCT00274469|3224477|Superiority||Hazard Ratio (HR)|0.6266||||0.0496|2-Sided|95.0|0.3929|0.9991|||Log Rank||HR<1 favours Fulvestrant||
1754925|NCT00274469|3224478|Superiority||Odds Ratio (OR)|1.021||||0.947|2-Sided|95.0|0.556|1.874|||Regression, Logistic||OR>1 favours Fulvestrant||
1754926|NCT00274469|3224479|Non-Inferiority|Study is powered basing on 20% deficiency in benefit rate for Fulvestrant compared to Anastrozole.|Odds Ratio (OR)|1.302||||0.386|2-Sided|95.0|0.717|2.38||Null hypothesis: Fulvestrant has no difference with Anastrozole|Regression, Logistic||OR>1 favours Fulvestrant||
1754927|NCT00274456|3224483|Superiority or Other (legacy)||Hazard Ratio (HR)|1.74||||0.008||95.0|||||Log Rank||||
1754928|NCT00274456|3224483|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank||||
1754929|NCT00274456|3224483|Superiority or Other (legacy)||Hazard Ratio (HR)|0.686|||>|0.069||95.0|||||Log Rank||||
1754930|NCT00274456|3224483|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank||||
1754931|NCT00274456|3224483|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank||||
1754932|NCT00274456|3224483|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank||||
1754933|NCT00274456|3224483|Superiority or Other (legacy)||||||>|0.047||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Log Rank||||
1754934|NCT00274456|3224484|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank|||Investigator assessment|
1754935|NCT00274456|3224484|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank|||Investigator assessment|
1754936|NCT00274456|3224484|Superiority or Other (legacy)||||||>|0.005|||||||Log Rank|||Investigator assessment|
1754937|NCT00274456|3224484|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank|||Investigator assessment|
1754938|NCT00274456|3224484|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank|||Investigator assessment|
1754939|NCT00274456|3224484|Superiority or Other (legacy)||||||>|0.022|||||||Log Rank|||Investigator assessment|
1754940|NCT00274456|3224484|Superiority or Other (legacy)||||||>|0.013||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Investigator assessment|
1754941|NCT00274456|3224485|Superiority or Other (legacy)||||||>|0.05||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Independent assessment|
1754942|NCT00274456|3224486|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank|||Investigator assessment|
1754943|NCT00274456|3224486|Superiority or Other (legacy)||Hazard Ratio (HR)|0.702|||>|0.076|||||||Log Rank|||Investigator assessment|
1754944|NCT00274456|3224486|Superiority or Other (legacy)||Hazard Ratio (HR)|1.972|||>|0.001|||||||Log Rank|||Investigator assessment|
1754945|NCT00274456|3224486|Superiority or Other (legacy)||Hazard Ratio (HR)|0.568|||>|0.012|||||||Log Rank|||Investigator assessment|
1754946|NCT00274456|3224486|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank|||Investigator assessment|
1754947|NCT00274456|3224486|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank|||Investigator assessment|
1754948|NCT00274456|3224486|Superiority or Other (legacy)||||||>|0.008||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons was performed only if this test was significant."|Log Rank|||Investigator assessment|
1754949|NCT00274456|3224486|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank|||Independent assessment|
1754950|NCT00274456|3224486|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank|||Independent assessment|
1754951|NCT00274456|3224486|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank|||Independent assessment|
1754952|NCT00274456|3224486|Superiority or Other (legacy)||||||>|0.05|||||||Log Rank|||Independent assessment|
1754953|NCT00274456|3224486|Superiority or Other (legacy)||Hazard Ratio (HR)|0.495|||>|0.0065|||||||Log Rank|||Independent assessment|
1754954|NCT00274456|3224486|Superiority or Other (legacy)||Hazard Ratio (HR)|0.607|||>|0.0524|||||||Log Rank|||Independent assessment|
1754955|NCT00274456|3224486|Superiority or Other (legacy)||||||>|0.0498||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Log Rank|||Independent assessment|
1754956|NCT00274456|3224487|Superiority or Other (legacy)|||||||0.014|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR|
1754957|NCT00274456|3224487|Superiority or Other (legacy)|||||||0.098|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR|
1754960|NCT00274456|3224487|Superiority or Other (legacy)||||||>|0.009|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR|
1754961|NCT00274456|3224487|Superiority or Other (legacy)||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed DCR|
1754962|NCT00274456|3224487|Superiority or Other (legacy)||||||>|0.007||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparison was performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed disease control rate (DCR), ie, SD >= 16 weeks, or CR or PR|
1754963|NCT00274456|3224487|Superiority or Other (legacy)||||||>|0.085|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR|
1754964|NCT00274456|3224487|Superiority or Other (legacy)||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR|
1754965|NCT00274456|3224487|Superiority or Other (legacy)||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR|
1754966|NCT00274456|3224487|Superiority or Other (legacy)||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR|
1754967|NCT00274456|3224487|Superiority or Other (legacy)||||||>|0.017|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR|
1754968|NCT00274456|3224487|Superiority or Other (legacy)||||||>|0.009|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR|
1754969|NCT00274456|3224487|Superiority or Other (legacy)||||||>|0.027|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Independent assessed DCR|
1754970|NCT00274456|3224488|Superiority or Other (legacy)|||||||0.002|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR|
1754971|NCT00274456|3224488|Superiority or Other (legacy)|||||||0.099|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR|
1754972|NCT00274456|3224488|Superiority or Other (legacy)|||||||0.024|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR|
1754973|NCT00274456|3224488|Superiority or Other (legacy)||||||>|0.05|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site||Investigator assessed ORR|
1754974|NCT00274456|3224488|Superiority or Other (legacy)||||||<|0.001|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site.||Investigator assessed ORR|
1754975|NCT00274456|3224488|Superiority or Other (legacy)||||||<|0.002|||||||Cochran-Mantel-Haenszel|CMH test was stratified by study site||Investigator assessed ORR|
1754976|NCT00274456|3224488|Superiority or Other (legacy)||||||<|0.001||||||A step-down approach was used to compare treatment regimens. First an overall “test of treatment difference” (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant.|Cochran-Mantel-Haenszel|CMH was stratified by study site||Investigator assessed ORR. As per the protocol, if the conclusions from the investigator and independent assessments of response rate were the same, the investigator assessment was considered the primary analysis of response rate. If the conclusions were different, the independent radiology reader assessment was considered the primary analysis of response rate. The conclusions were different.|
1754977|NCT00274456|3224488|Superiority or Other (legacy)||||||<|0.224||||||"A step-down approach was used to compare treatment regimens. First an overall test of treatment difference (a 3-degree-of -freedom test) was performed. Pairwise comparisons were performed only if this test was significant."|Cochran-Mantel-Haenszel|CMH test was stratified by study site||Independent reader assessed ORR. As per the protocol, if the conclusions from the investigator and independent assessments of response rate were the same, the investigator assessment was considered the primary analysis of response rate. If the conclusions were different, the independent radiology reader assessment was considered the primary analysis of response rate. The conclusions were different.|
1754978|NCT00273182|3224512|Superiority or Other||event free rate|89.8|||||2-Sided|95.0|88.3|91.2||||||Kaplan-Meier (product limit) estimate of the curve representing the time to first post-implant LV lead related complication were calculated to the first time point where fewer than 50 patients are still at risk. Confidence intervals will be calculated on a log-log scale.|
1754979|NCT00273182|3224516|Superiority or Other||Cause specific survival rate at 36 month|85.3|||||2-Sided|95.0|83.3|87.1|||||left-truncation methods were used in the survival analysis for previously implanted subjects.|For cause-specific mortality, the endpoint is the proportion of patients who are alive or do not die due to the progressive heart failure or sudden cardiac death causes during 3 years post-implant. Survival curves of cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals were calculated on a log-log scale.|
1754980|NCT00273182|3224516|Superiority or Other||Overall survival rate at 36 month|71.0|||||2-Sided|95.0|68.6|73.2|||||The estimate is the overall survival rate at 36 month. left-truncation methods were used in the survival analysis for previously implanted subjects.|For overall mortality, the endpoint is the proportion of subjects alive during three years post-implant. Survival curves of overall mortality and cause-specific mortality were created based on Kaplan-Meier (product limit) estimates. Confidence intervals will be calculated on a log-log scale.|
1754981|NCT00273052|3224529|Superiority or Other||Mean Difference (Net)|0.7||||0.6068||95.0|-2.4|3.9|||ANCOVA||Mean difference = Coreg CR - Toprol XL||
1754982|NCT00273052|3224530|Superiority or Other||Median Difference (Net)|-8.026||||0.0141||95.0|-15.35|-0.67|||ANCOVA||Median difference = Coreg CR - Toprol XL||
1754983|NCT00272961|3224549|Superiority or Other||LS Mean Difference|1.07|Standard Error of the Mean|3.77||0.7791|2-Sided|95.0|-6.69|8.83|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754984|NCT00272961|3224549|Superiority or Other||LS Mean Difference|4.78|Standard Error of the Mean|3.67||0.2042|2-Sided|95.0|-2.76|12.31|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1755028|NCT00272961|3224557|Superiority or Other||LS Mean Difference|41.26|Standard Error of the Mean|177.26||0.8174|2-Sided|95.0|-319.8|402.3|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1754985|NCT00272961|3224549|Superiority or Other||LS Mean Difference|-1.38|Standard Error of the Mean|3.48||0.6943|2-Sided|95.0|-8.54|5.78|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754986|NCT00272961|3224549|Superiority or Other||LS Mean Difference|3.45|Standard Error of the Mean|4.12||0.4098|2-Sided|95.0|-5.01|11.91|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754987|NCT00272961|3224549|Superiority or Other||LS Mean Difference|-1.34|Standard Error of the Mean|3.67||0.7172|2-Sided|95.0|-8.9|6.21|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754988|NCT00272961|3224549|Superiority or Other||LS Mean Difference|2.71|Standard Error of the Mean|3.61||0.4612|2-Sided|95.0|-4.74|10.15|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754989|NCT00272961|3224549|Superiority or Other||LS Mean Difference|-4.88|Standard Error of the Mean|3.49||0.1739|2-Sided|95.0|-12.07|2.3|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754990|NCT00272961|3224549|Superiority or Other||LS Mean Difference|1.21|Standard Error of the Mean|4.08||0.7685|2-Sided|95.0|-7.19|9.62|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754991|NCT00272961|3224550|Superiority or Other||LS Mean Difference|3.83|Standard Error of the Mean|4.51||0.4037|2-Sided|95.0|-5.45|13.11|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754992|NCT00272961|3224550|Superiority or Other||LS Mean Difference|-2.1|Standard Error of the Mean|4.34||0.6329|2-Sided|95.0|-11.01|6.82|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754993|NCT00272961|3224550|Superiority or Other||LS Mean Difference|-4.21|Standard Error of the Mean|4.33||0.3401|2-Sided|95.0|-13.11|4.7|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754994|NCT00272961|3224550|Superiority or Other||LS Mean Difference|-2.93|Standard Error of the Mean|5.12||0.5719|2-Sided|95.0|-13.46|7.6|||ANCOVA|||Week 10 Standing: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754995|NCT00272961|3224550|Superiority or Other||LS Mean Difference|-1.3|Standard Error of the Mean|4.79||0.7883|2-Sided|95.0|-11.17|8.57|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754996|NCT00272961|3224550|Superiority or Other||LS Mean Difference|-2.47|Standard Error of the Mean|4.56||0.5936|2-Sided|95.0|-11.86|6.93|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754997|NCT00272961|3224550|Superiority or Other||LS Mean Difference|-3.85|Standard Error of the Mean|4.57||0.408|2-Sided|95.0|-13.26|5.57|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754998|NCT00272961|3224550|Superiority or Other||LS Mean Difference|-3.74|Standard Error of the Mean|5.39||0.4933|2-Sided|95.0|-14.84|7.35|||ANCOVA|||Week 10 Sitting: p-value was obtained using an ANCOVA model on the post-dose minus pre-dose difference at Week 10 with the post-dose minus pre-dose difference at Baseline as a covariate.|
1754999|NCT00272961|3224551|Superiority or Other||LS Mean Difference|-2.08|Standard Error of the Mean|1.95||0.2962|2-Sided|95.0|-6.09|1.93|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755000|NCT00272961|3224551|Superiority or Other||LS Mean Difference|-1.95|Standard Error of the Mean|1.9||0.3135|2-Sided|95.0|-5.86|1.96|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755001|NCT00272961|3224551|Superiority or Other||LS Mean Difference|-1.19|Standard Error of the Mean|1.87||0.5298|2-Sided|95.0|-5.04|2.66|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755002|NCT00272961|3224551|Superiority or Other||LS Mean Difference|-2.77|Standard Error of the Mean|2.21||0.2204|2-Sided|95.0|-7.32|1.77|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755003|NCT00272961|3224551|Superiority or Other||LS Mean Difference|-0.52|Standard Error of the Mean|1.4||0.7113|2-Sided|95.0|-3.41|2.36|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755004|NCT00272961|3224551|Superiority or Other||LS Mean Difference|0.23|Standard Error of the Mean|1.36||0.8656|2-Sided|95.0|-2.58|3.04|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755005|NCT00272961|3224551|Superiority or Other||LS Mean Difference|0.47|Standard Error of the Mean|1.34||0.7269|2-Sided|95.0|-2.29|3.24|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755496|NCT00265317|3225380|Superiority or Other|||||||0.3681||||||2-sided normal approximated p-value|Wilcoxon Rank Sum Test||||
1755006|NCT00272961|3224551|Superiority or Other||LS Mean Difference|-2.99|Standard Error of the Mean|1.59||0.0714|2-Sided|95.0|-6.25|0.28|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755007|NCT00272961|3224552|Superiority or Other||LS Mean Difference|0.97|Standard Error of the Mean|3.08||0.7556|2-Sided|95.0|-5.38|7.31|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755008|NCT00272961|3224552|Superiority or Other||LS Mean Difference|3.92|Standard Error of the Mean|2.73||0.1625|2-Sided|95.0|-1.69|9.54|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755009|NCT00272961|3224552|Superiority or Other||LS Mean Difference|1.34|Standard Error of the Mean|2.72||0.6249|2-Sided|95.0|-4.25|6.94|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755010|NCT00272961|3224552|Superiority or Other||LS Mean Difference|3.18|Standard Error of the Mean|3.32||0.347|2-Sided|95.0|-3.65|10.01|||ANCOVA|||Post-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Post-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755011|NCT00272961|3224552|Superiority or Other||LS Mean Difference|2.17|Standard Error of the Mean|2.78||0.4424|2-Sided|95.0|-3.56|7.91|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755012|NCT00272961|3224552|Superiority or Other||LS Mean Difference|1.86|Standard Error of the Mean|2.46||0.4573|2-Sided|95.0|-3.21|6.93|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755013|NCT00272961|3224552|Superiority or Other||LS Mean Difference|-0.35|Standard Error of the Mean|2.45||0.888|2-Sided|95.0|-5.4|4.71|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755014|NCT00272961|3224552|Superiority or Other||LS Mean Difference|0.86|Standard Error of the Mean|3.0||0.7758|2-Sided|95.0|-5.31|7.03|||ANCOVA|||Pre-Dose on Week 10: p-value was obtained using an ANCOVA model on the sitting-standing difference at Week 10 (Pre-Dose) with the sitting-standing difference at Baseline as a covariate.|
1755015|NCT00272961|3224557|Superiority or Other||LS Mean Difference|157.66|Standard Error of the Mean|104.33||0.1382|2-Sided|95.0|-52.9|368.2|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755016|NCT00272961|3224557|Superiority or Other||LS Mean Difference|254.9|Standard Error of the Mean|104.0||0.0185|2-Sided|95.0|45.0|464.8|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755017|NCT00272961|3224557|Superiority or Other||LS Mean Difference|157.99|Standard Error of the Mean|102.21||0.1297|2-Sided|95.0|-48.3|364.3|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755018|NCT00272961|3224557|Superiority or Other||LS Mean Difference|240.64|Standard Error of the Mean|114.32||0.0413|2-Sided|95.0|9.9|471.4|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755019|NCT00272961|3224557|Superiority or Other||LS Mean Difference|133.22|Standard Error of the Mean|96.7383||0.178|2-Sided|95.0|-63.8|330.3|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755020|NCT00272961|3224557|Superiority or Other||LS Mean Difference|224.89|Standard Error of the Mean|96.9259||0.0269|2-Sided|95.0|27.5|422.3|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755021|NCT00272961|3224557|Superiority or Other||LS Mean Difference|114.77|Standard Error of the Mean|93.2637||0.2274|2-Sided|95.0|-75.2|304.8|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755022|NCT00272961|3224557|Superiority or Other||LS Mean Difference|225.57|Standard Error of the Mean|108.95||0.0466|2-Sided|95.0|3.6|447.5|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755023|NCT00272961|3224557|Superiority or Other||LS Mean Difference|50.59|Standard Error of the Mean|117.93||0.6701|2-Sided|95.0|-187.4|288.6|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755024|NCT00272961|3224557|Superiority or Other||LS Mean Difference|24.67|Standard Error of the Mean|117.88||0.8352|2-Sided|95.0|-213.2|262.6|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755025|NCT00272961|3224557|Superiority or Other||LS Mean Difference|115.35|Standard Error of the Mean|116.03||0.3258|2-Sided|95.0|-118.8|349.5|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755026|NCT00272961|3224557|Superiority or Other||LS Mean Difference|163.04|Standard Error of the Mean|130.15||0.2172|2-Sided|95.0|-99.6|425.7|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755027|NCT00272961|3224557|Superiority or Other||LS Mean Difference|166.4|Standard Error of the Mean|177.55||0.3557|2-Sided|95.0|-195.3|528.1|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755134|NCT00270855|3224779|Other|A Mann-Whitney U test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention|
1755029|NCT00272961|3224557|Superiority or Other||LS Mean Difference|103.67|Standard Error of the Mean|173.86||0.5552|2-Sided|95.0|-250.5|457.8|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755030|NCT00272961|3224557|Superiority or Other||LS Mean Difference|232.59|Standard Error of the Mean|201.83||0.2577|2-Sided|95.0|-178.5|643.7|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on AUEC calculated over treatment and follow-up phases with baseline value as a covariate.|
1755031|NCT00272961|3224558|Superiority or Other||LS Mean Difference|1.65|Standard Error of the Mean|2.4||0.495|2-Sided|95.0|-3.2|6.5|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755032|NCT00272961|3224558|Superiority or Other||LS Mean Difference|5.64|Standard Error of the Mean|2.4||0.023|2-Sided|95.0|0.8|10.47|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755033|NCT00272961|3224558|Superiority or Other||LS Mean Difference|0.8|Standard Error of the Mean|2.36||0.737|2-Sided|95.0|-3.96|5.55|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755034|NCT00272961|3224558|Superiority or Other||LS Mean Difference|4.8|Standard Error of the Mean|2.56||0.067|2-Sided|95.0|-0.36|9.95|||ANCOVA|||Standing DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755035|NCT00272961|3224558|Superiority or Other||LS Mean Difference|0.99|Standard Error of the Mean|2.5||0.695|2-Sided|95.0|-4.09|6.07|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755036|NCT00272961|3224558|Superiority or Other||LS Mean Difference|6.37|Standard Error of the Mean|2.5||0.016|2-Sided|95.0|1.28|11.45|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755037|NCT00272961|3224558|Superiority or Other||LS Mean Difference|1.43|Standard Error of the Mean|2.41||0.557|2-Sided|95.0|-3.47|6.33|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755038|NCT00272961|3224558|Superiority or Other||LS Mean Difference|5.62|Standard Error of the Mean|2.68||0.044|2-Sided|95.0|0.17|11.08|||ANCOVA|||Sitting DBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755039|NCT00272961|3224558|Superiority or Other||LS Mean Difference|-5.71|Standard Error of the Mean|4.56||0.218|2-Sided|95.0|-14.91|3.5|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755040|NCT00272961|3224558|Superiority or Other||LS Mean Difference|-0.57|Standard Error of the Mean|4.56||0.9|2-Sided|95.0|-9.78|8.63|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755041|NCT00272961|3224558|Superiority or Other||LS Mean Difference|0.68|Standard Error of the Mean|4.49||0.88|2-Sided|95.0|-8.37|9.73|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755042|NCT00272961|3224558|Superiority or Other||LS Mean Difference|6.1|Standard Error of the Mean|4.9||0.221|2-Sided|95.0|-3.79|15.99|||ANCOVA|||Standing SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755043|NCT00272961|3224558|Superiority or Other||LS Mean Difference|1.01|Standard Error of the Mean|5.72||0.861|2-Sided|95.0|-10.62|12.64|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755044|NCT00272961|3224558|Superiority or Other||LS Mean Difference|-0.04|Standard Error of the Mean|5.71||0.994|2-Sided|95.0|-11.66|11.57|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755045|NCT00272961|3224558|Superiority or Other||LS Mean Difference|0.21|Standard Error of the Mean|5.59||0.97|2-Sided|95.0|-11.16|11.59|||ANCOVA|||Sitting SBP: p-value was obtained using an ANCOVA model on the maximum increase observed with baseline value as a covariate.|
1755046|NCT00272961|3224558|Superiority or Other||Least Squares (LS) Mean Difference|8.37|Standard Error of the Mean|6.19||0.185|2-Sided|95.0|-4.21|20.96|||ANCOVA|||Sitting SBP: p-value was obtained using an Analysis of Co-variance (ANCOVA) model on the maximum increase observed with baseline value as a covariate.|
1755047|NCT00272792|3224562|Superiority or Other|||||||0.009|||||||Longitudinal Model|Longitudinal model with blood Phe measurements as the response variable and treatment group, visit, and baseline blood Phe level as covariates.|||
1755048|NCT00272792|3224563|Superiority or Other|||||||0.027|||||||t-test, 1 sided|||Compared Week 10 to Baseline.|
1755049|NCT00272792|3224563|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||Compared Week 10 to Baseline.|
1755050|NCT00272779|3224564|Superiority or Other|||||||0.1696||||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT-to-TAT Ratio (phenotype) and the CCDA122_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDA122_5980 reported in Outcome Measure 16.|
1755071|NCT00272779|3224624|Superiority or Other||Difference Estimate|5.1|||||2-Sided|95.0|-0.4|10.6||||||Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV–LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization—ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).|
1758391|NCT00205777|3229641|Superiority or Other|||||||0.9|||||||ANOVA||||
1755051|NCT00272779|3224565|Superiority or Other|||||||0.1335||||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the RETN_730 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_730 reported in Outcome Measure 16.|
1755052|NCT00272779|3224566|Superiority or Other|||||||0.1335||||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in VAT (phenotype) and the BRUNOL_1842 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with BRUNOL_1842 reported in Outcome Measure 16.|
1755053|NCT00272779|3224567|Superiority or Other|||||||0.1694||||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in SAT-to-TAT Ratio (phenotype) and the CCDC122_5980 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with CCDC122_5980 reported in Outcome Measure 16.|
1755054|NCT00272779|3224568|Superiority or Other|||||||0.1833||||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting TNF-alpha (phenotype) and the RS11030679 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_097 reported in Outcome Measure 16.|
1755055|NCT00272779|3224569|Superiority or Other|||||||0.1833||||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)||Null Hypothesis:There is no association between the mean change from baseline in fasting Tumor Necrosis Factor(TNF)-alpha (phenotype) and the IL6_5309 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, wk48 and 96) to test the overall genotype effect (ie. an omnibus test on both marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with IL6_5309 reported in Outcome Measure 16|
1755056|NCT00272779|3224570|Superiority or Other|||||||0.1847||||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting PAI-1 (phenotype) and the APOE_R176C genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE_R176C reported in Outcome Measure 16.|
1755057|NCT00272779|3224571|Superiority or Other|||||||0.1173||||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN_734 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_734 reported in Outcome Measure 16.|
1755072|NCT00272779|3224625|Superiority or Other||Difference Estimate|6.1|||||2-Sided|95.0|0.3|12.0||||||Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir– lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization—HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting|
1755073|NCT00272779|3224647|Superiority or Other||Difference Estimate|-16.4|||||2-Sided|95.0|-35.9|3.1||||||Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.|
1755058|NCT00272779|3224572|Superiority or Other|||||||0.1173||||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the APOE_C130R genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with APOE_C130R reported in Outcome Measure 16.|
1755059|NCT00272779|3224573|Superiority or Other|||||||0.0253||||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN_598 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_598 reported in Outcome Measure 16.|
1755060|NCT00272779|3224574|Superiority or Other|||||||0.0058||||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN_2265 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, weeks 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_2265 reported in Outcome Measure 16.|
1755061|NCT00272779|3224575|Superiority or Other|||||||0.0058||||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting triglycerides (phenotype) and the RETN_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_097 reported in Outcome Measure 16.|
1755062|NCT00272779|3224576|Superiority or Other|||||||0.0847||||||The explanatory variables in the model include treatment, genotype, time, and their interaction effects as fixed effects and the spatial exponential with respect to time from baseline was used to model the covariance structure of repeated measures.|linear mixed effect model|The FDR multiple testing adjustment was used to adjust p-values for the number of SNPs being tested (only SNPs with FDR-adj p-values <0.2 reported)||Null Hypothesis: There is no association between the mean change from baseline in fasting non-HDL cholesterol (phenotype) and the RETN_097 genotypes. A single SNP association analysis was conducted using the linear mixed effect model for repeated measures (baseline, week 48 and 96) to test the overall genotype effect (i.e. an omnibus test on both the marginal genotype effect and the genotype-by-treatment interaction effect). Number of participants with RETN_097 reported in Outcome Measure 16.|
1755063|NCT00272779|3224600|Superiority or Other||point estimate|0.89|||||2-Sided|90.0|0.689|1.151|||||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.||
1755064|NCT00272779|3224601|Superiority or Other||point estimate|0.853|||||2-Sided|90.0|0.626|1.161|||||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.||
1755065|NCT00272779|3224602|Superiority or Other||point estimate|0.925|||||2-Sided|90.0|0.699|1.223|||||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.||
1755066|NCT00272779|3224603|Superiority or Other||point estimate|0.282|||||2-Sided|90.0|0.181|0.439|||||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.||
1755067|NCT00272779|3224604|Superiority or Other||point estimate|0.839|||||2-Sided|90.0|0.612|1.151|||||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.||
1755068|NCT00272779|3224605|Superiority or Other||point estimate|1.46|||||2-Sided|90.0|1.005|2.121|||||Point estimates and 90% CIs for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.||
1755069|NCT00272779|3224606|Superiority or Other||point estimate|0.761|||||2-Sided|90.0|0.507|1.142|||||Point estimates and 90% confidence intervals (CIs) for differences between treatment regimens were calculated on the log scale, and were exponentiated to obtain estimates for ratios of geometric means on the original scale.||
1755070|NCT00272779|3224622|Superiority or Other||Difference Estimate|-21.2|||||2-Sided|95.0|-43.3|0.9||||||Mean changes in CD4 cell counts from baseline at week 48 were compared between treatment regimens with 95% CIs based on stratified normal approximations and observed values.|
1755132|NCT00270855|3224777|Non-Inferiority or Equivalence|A mann-whitney u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention|
1755074|NCT00272779|3224650|Superiority or Other||Difference Estimate|3.3|||||2-Sided|95.0|-1.5|8.1||||||Treatment regimens were compared by calculation of the difference in proportions (ATV/RTV–LPV/RTV) and 95% CI based on a stratified normal approximation. Analyses were stratified by the same strata as randomization—ie, HIV RNA level at enrollment and geographic region. The proportion of participants with HIV RNA below 400 copies per mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size (Cochran-Mantel-Haenszel weighting).|
1755075|NCT00272779|3224651|Superiority or Other||Difference Estimate|1.7|||||2-Sided|95.0|-3.8|7.1||||||Treatment regimens compared by calculation of the difference in proportions (atazanavir/ritonavir– lopinavir/ritonavir) and 95% CI based on stratified normal approximation.Analyses were stratified by the same strata as randomization—HIV RNA level at enrollment and geographic region.The proportion of participants with HIV RNA below 50 copies/mL was computed within each stratum, and combined by use of a weighted average with weights proportional to stratum size:Cochran-Mantel-Haenszel weighting|
1755076|NCT00271817|3224675|Superiority or Other||Mean Difference (Final Values)|-7.7|Standard Error of the Mean|1.4|<|0.001||95.0|-10.4|-5.0||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin||
1755077|NCT00271817|3224676|Superiority or Other||Mean Difference (Final Values)|-4.9|Standard Error of the Mean|1.4|<|0.001||95.0|-7.7|-2.1||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin||
1755078|NCT00271817|3224677|Superiority or Other||Mean Difference (Final Values)|-4.8|Standard Error of the Mean|1.6||0.004||95.0|-8.0|-1.5||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin||
1755079|NCT00271817|3224678|Superiority or Other||Mean Difference (Final Values)|-7.3|Standard Error of the Mean|1.6|<|0.001||95.0|-10.4|-4.2||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Median difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin||
1755080|NCT00271817|3224679|Superiority or Other||Median Difference (Final Values)|-17.6|||<|0.001||95.0|-21.8|-13.6||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline LDL-C, baseline TG and gender.|"Median difference = Ezetimibe/Simvastatin + Niacin minus Ezetimibe/Simvastatin~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon’s rank sum test statistic."||
1755081|NCT00271817|3224680|Superiority or Other||Mean Difference (Final Values)|21.5|Standard Error of the Mean|1.8|<|0.001||95.0|18.0|25.0||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin||
1755082|NCT00271817|3224681|Superiority or Other||Median Difference (Final Values)|-18.7|||<|0.001||95.0|-22.6|-14.7||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment, baseline LDL-C, baseline TG and gender|"Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin~The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon’s rank sum test statistic."||
1755083|NCT00271817|3224682|Superiority or Other||Mean Difference (Final Values)|22.1|Standard Error of the Mean|1.6|<|0.001||95.0|18.8|25.3||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin||
1755084|NCT00271817|3224683|Superiority or Other||Mean Difference (Final Values)|-33.5|Standard Error of the Mean|1.5|<|0.001||95.0|-36.5|-30.6||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin||
1755085|NCT00271817|3224684|Superiority or Other||Mean Difference (Final Values)|-38.4|Standard Error of the Mean|1.5|<|0.001||95.0|-41.4|-35.4||A fixed sequence testing procedure was employed where testing followed a prespecified order and each subsequent hypothesis was tested at the 0.05 level of significance only if all previously tested hypotheses have been rejected.|ANCOVA|ANCOVA with terms for treatment, baseline LDL-C, baseline TG, and gender.|Mean difference = Ezetimibe/Simvastatin + Niacin minus Niacin||
1755086|NCT00271596|3224690|Superiority or Other||Odds Ratio (OR)|-2.5|Standard Error of the Mean|1.23||0.05|2-Sided|95.0|-5.04|0.04||Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|Mixed Models Analysis|||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|
1755133|NCT00270855|3224778|Non-Inferiority or Equivalence|We used a Mann-Whitney U test.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||we evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention|
1755087|NCT00271596|3224691|Superiority or Other||Mean Difference (Net)|-0.48|Standard Error of the Mean|0.68||0.49|2-Sided|95.0|-1.87|0.91|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|
1755088|NCT00271596|3224692|Superiority or Other||Mean Difference (Net)|-1.9|Standard Error of the Mean|1.17||0.12|2-Sided|95.0|-4.3|0.5|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|
1755089|NCT00271596|3224693|Superiority or Other||Median Difference (Net)|-0.317|Standard Error of the Mean|0.482||0.512|2-Sided|95.0|-1.276|0.642|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|
1755090|NCT00271596|3224694|Superiority or Other||Mean Difference (Net)|-0.21|Standard Error of the Mean|0.174||0.23||95.0|-0.554|0.135|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|
1755091|NCT00271596|3224695|Superiority or Other||Mean Difference (Net)|0.069|Standard Error of the Mean|0.15||0.646|2-Sided|95.0|-0.229|0.367|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|
1755092|NCT00271596|3224696|Superiority or Other||Mean Difference (Net)|-0.057|Standard Error of the Mean|0.153||0.708|2-Sided|95.0|-0.361|0.246|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|
1755093|NCT00271596|3224697|Superiority or Other||Mean Difference (Net)|-0.278|Standard Error of the Mean|0.268||0.302|2-Sided|95.0|-0.81|0.254|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic)||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|
1755094|NCT00271596|3224698|Superiority or Other||Mean Difference (Net)|-0.337|Standard Error of the Mean|0.168||0.048|2-Sided|95.0|-0.672|-0.003|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|
1755095|NCT00271596|3224699|Superiority or Other||Mean Difference (Net)|-0.166|Standard Error of the Mean|0.098||0.092|2-Sided|95.0|-0.361|0.028|||2-tailed linear treatment contrast|This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).||Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).|
1755096|NCT00271544|3224714|Superiority or Other||One sample proportion|0.973||||||95.0|0.95|0.996|||||||
1755097|NCT00271544|3224715|Superiority or Other||One sample proportion|0.973||||||95.0|0.95|0.996|||||||
1755098|NCT00271544|3224716|Superiority or Other||One sample proportion|0.989||||||95.0|0.974|1.0|||||||
1755099|NCT00271544|3224717|Superiority or Other||One sample mean|1.9|Standard Deviation|2.0||||97.5|1.9|2.2|||||1-sided 97.5% confidence limit upper bound||
1755100|NCT00271544|3224718|Superiority or Other||One sample mean|1.1|Standard Deviation|0.9||||95.0|1.1|1.2|||||1-side 95% confidence limit upper bound||
1755101|NCT00271544|3224719|Superiority or Other||One sample proportion|0.96||||||95.0|0.932|0.989|||||||
1755102|NCT00271544|3224720|Superiority or Other||One sample proportion|0.955||||||95.0|0.92|0.955|||||1-side 95% confidence limit lower bound||
1755103|NCT00271154|3224744|Superiority or Other|||||||0.1|||||||Chi-squared|||Null hypothesis: Percentage worsened in CRT OFF group = Percentage worsened in CRT ON group|
1755104|NCT00271154|3224745|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Null hypothesis: mean 12-month change in LVESVi in group 1 = mean 12-month change in LVESVi in group 2.|
1755105|NCT00270998|3224760|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755106|NCT00270998|3224760|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755107|NCT00270998|3224760|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755108|NCT00270998|3224761|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755109|NCT00270998|3224761|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.048|||||||Regression, Logistic||||
1755497|NCT00265317|3225385|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||sKIT Ratio to Baseline for Cycle 3, Day 1|
1755110|NCT00270998|3224761|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.03|||||||Regression, Logistic||||
1755111|NCT00270998|3224762|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755112|NCT00270998|3224762|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755113|NCT00270998|3224762|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755114|NCT00270998|3224763|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755115|NCT00270998|3224763|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755116|NCT00270998|3224763|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755117|NCT00270998|3224764|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755118|NCT00270998|3224764|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755119|NCT00270998|3224764|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755120|NCT00270998|3224765|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755121|NCT00270998|3224765|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755122|NCT00270998|3224765|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492|||||||Regression, Logistic||||
1755123|NCT00270998|3224766|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.42|||||||Regression, Logistic||||
1755124|NCT00270998|3224766|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.048|||||||Regression, Logistic||||
1755125|NCT00270998|3224766|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.006|||||||Regression, Logistic||||
1755126|NCT00270998|3224767|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.49||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.|
1755127|NCT00270998|3224767|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.||||||0.02||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.|
1755128|NCT00270998|3224767|Non-Inferiority|Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made.|||||<|0.0492||||||A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis|Regression, Logistic|||A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group.|
1755129|NCT00270855|3224775|Non-Inferiority or Equivalence|A Mann-Whitney U test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention|
1755130|NCT00270855|3224776|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group|
1755131|NCT00270855|3224776|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group|
1755135|NCT00270855|3224780|Non-Inferiority or Equivalence|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention|
1755136|NCT00270855|3224781|Non-Inferiority or Equivalence|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention|
1755137|NCT00270855|3224782|Non-Inferiority or Equivalence|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention|
1755138|NCT00270855|3224783|Non-Inferiority or Equivalence|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention|
1755139|NCT00270855|3224784|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group|
1755140|NCT00270855|3224784|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group|
1755141|NCT00270855|3224785|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group|
1755142|NCT00270855|3224785|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group|
1755143|NCT00270855|3224786|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group|
1755144|NCT00270855|3224786|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group|
1755145|NCT00270855|3224787|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group|
1755146|NCT00270855|3224787|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group|
1755147|NCT00270855|3224788|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group|
1755148|NCT00270855|3224788|Non-Inferiority or Equivalence|Wilcoxon signed-rank test was performed|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group|
1755149|NCT00270855|3224789|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group|
1755150|NCT00270855|3224789|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group|
1755151|NCT00270855|3224790|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group|
1755152|NCT00270855|3224790|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group|
1755153|NCT00270855|3224791|Non-Inferiority or Equivalence|A Mann-Whitney-u test was performed|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention|
1755154|NCT00270855|3224792|Non-Inferiority or Equivalence|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention|
1755155|NCT00270855|3224793|Non-Inferiority or Equivalence|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention|
1755156|NCT00270855|3224794|Non-Inferiority or Equivalence|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention|
1755157|NCT00270855|3224795|Non-Inferiority or Equivalence|A Mann-Whitney-u test was performed.|||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||We evaluated differences in the above variable between the ACE and FESLCE following the the 16-week exercise intervention|
1755158|NCT00270855|3224796|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group|
1755159|NCT00270855|3224796|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group|
1755160|NCT00270855|3224797|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group|
1755161|NCT00270855|3224797|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.615|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group|
1755162|NCT00270855|3224798|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group|
1758392|NCT00205777|3229641|Superiority or Other|||||||0.26|||||||ANOVA||||
1755163|NCT00270855|3224798|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.519|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group.|
1755164|NCT00270855|3224799|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group|
1755165|NCT00270855|3224799|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group|
1755166|NCT00270855|3224800|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the FESLCE group (i.e, baseline vs. post-intervention in FESLCE)|
1755167|NCT00270855|3224800|Non-Inferiority or Equivalence|A Wilcoxon signed-rank test was performed.|||||>|0.05|||||||t-test, 2 sided|||We evaluated differences between baseline and following the 16-week exercise intervention in the ACE group (i.e, baseline vs. post-intervention in ARE)|
1755168|NCT00270634|3224811|Non-Inferiority or Equivalence|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be –0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|4.9|||||1-Sided|95.0||11.4|||||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.||
1755169|NCT00270634|3224811|Non-Inferiority or Equivalence|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be –0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|4.6|||||1-Sided|95.0||10.8|||||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.||
1755170|NCT00270634|3224811|Non-Inferiority or Equivalence|The sample size was determined holding the probability of a type-I error at a = 0.05, and the power at 0.76. The rate of BPAR at 6 months posttransplant was assumed to be 0.20 in the control arm, and the noninferiority margin was chosen to be –0.15. A sample size for this phase-2b trial is determined to be 76 subjects in each dose group or a total of 304 patients. Assuming a 10% dropout rate during the study, ∼332 subjects were to be proportionally randomized in this study.|Weighted Average Difference|-3.2|||||1-Sided|95.0||1.3|||||The upper bound of the confidence interval was a measure of non-inferiority of VCS to TAC. VCS was considered non-inferior to TAC if the upper one-sided 95% confidence bound was less than 15%.|The 6-month BPAR rate was used to calculate an estimate of the difference in rates between each VCS group and TAC, combining across pooled investigative center strata, weighted by the number of patients in each of the pooled center strata. The overall standard error was estimated for the linear combination of proportions. Using this statistic and its standard error, the upper bound one-sided 95% C.I. was constructed for the difference in BPAR rates between groups (VCS – TAC).|
1755171|NCT00270257|3224814|Superiority or Other||Incident rate of 100 person-years|0.0|||||2-Sided|95.0|0.0|10.1|||||0 events over 37 person-years||
1755172|NCT00270257|3224814|Superiority or Other||Incident rate of 100 person-years|2.7|||||2-Sided|95.0|1.22|5.08|||||9 events over 336 person-years||
1755173|NCT00270257|3224815|Superiority or Other||Incident rate of 100 person-years|4.59|||||2-Sided|95.0|2.0|9.0|||||8 events over 174 person-years||
1755174|NCT00270257|3224815|Superiority or Other||Incident rate of 100 person-years|22.0|||||2-Sided|95.0|14.7|31.6|||||29 events over 132 person-years||
1755175|NCT00270257|3224816|Superiority or Other||Odds Ratio (OR)|0.8712||||0.362|2-Sided|95.0|0.6477|1.1718||P value applies for the comparison at visit 104 only. See the estimation comments for the other visits|Generalized linear model|adjusted for site.|||
1755176|NCT00270257|3224817|Superiority or Other||Odds Ratio (OR)|0.746||||0.3446|2-Sided|95.0|0.407|1.369||Analysis is done for visit 104|Regression, Logistic|Adjusted for site|||
1755177|NCT00270257|3224818|Superiority or Other||Odds Ratio (OR)|0.8||||0.2749|2-Sided|95.0|0.536|1.194||P value applies for the comparison at visit 104 only.|Regression, Logistic||||
1755178|NCT00270257|3224819|Superiority or Other||Odds Ratio (OR)|0.844||||0.4325|2-Sided|95.0|0.553|1.289||P value applies for the comparison at visit 104.|Regression, Logistic|adjusted for site|||
1755179|NCT00270257|3224820|Superiority or Other||Cox Proportional Hazard|0.694||||0.3769|2-Sided|95.0|0.308|1.562|||Regression, Cox||||
1755180|NCT00270257|3224820|Superiority or Other||Incident rate per 100 person-years|2.2|||||2-Sided|95.0|1.2|3.7|||||||
1755181|NCT00270257|3224820|Superiority or Other||Incident rate per 100 person-years|1.5|||||2-Sided|95.0|0.7|2.8|||||||
1755182|NCT00269152|3224873|Superiority or Other||Feasibility Response Rate (percentage)|50.0||||||95.0|36.1|63.9|||||||
1755183|NCT00269152|3224873|Superiority or Other||Feasibility Response Rate (percentage)|59.4|||||2-Sided|95.0|46.4|71.5|||||||
1755184|NCT00269113|3224874|Superiority or Other|||||||0.0017|||||||Log Rank||||
1755185|NCT00269113|3224875|Superiority or Other|||||||0.0002|||||||Log Rank||||
1755186|NCT00269113|3224876|Superiority or Other|||||||0.0186|||||||Log Rank||||
1755187|NCT00269113|3224877|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1755188|NCT00269113|3224878|Superiority or Other|||||||0.0127|||||||Log Rank||||
1755189|NCT00269113|3224879|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1755190|NCT00269113|3224880|Superiority or Other||Difference in percentage of participants|17.4||||0.0009|2-Sided|95.0|6.4|28.4|||Fisher Exact||||
1755213|NCT00268996|3224918|Superiority or Other||Difference in adjusted means|-5.165||||0.012|2-Sided|95.0|-9.185|-1.145|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).||
1755191|NCT00268996|3224906|Superiority or Other||Adjusted Treatment Difference|0.739||||0.54|2-Sided|95.0|-1.635|3.114|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibro-fatty as percentage of VH plaque|
1755192|NCT00268996|3224906|Superiority or Other||Adjusted Treatment Difference|2.0||||0.021|2-Sided|95.0|0.299|3.701|||ANOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibrous tissue as % of VH plaque|
1755193|NCT00268996|3224907|Superiority or Other||Adjusted Treatment Difference|1.926||||0.418|2-Sided|95.0|-2.748|6.6||Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibro-fatty volume|
1755194|NCT00268996|3224907|Superiority or Other||Adjusted Treatment Difference|-0.584||||0.854|2-Sided|95.0|-6.819|5.65|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value, matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Fibrous tissue volume|
1755195|NCT00268996|3224908|Superiority or Other||Adjusted Treatment Difference|0.061||||0.687|2-Sided|95.0|-0.237|0.36|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean lumen area|
1755196|NCT00268996|3224908|Superiority or Other||Adjusted Treatment Difference|0.048||||0.756|2-Sided|95.0|-0.258|0.354|||ANCOVA|Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean vessel area|
1755197|NCT00268996|3224908|Superiority or Other||Adjusted Treatment Difference|-0.012||||0.873|2-Sided|95.0|-0.16|0.136||Data analyzed using ANCOVA, with ACS status, pooled country, baseline value , matched segment length and treatment included as covariates.|ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet one daily - Placebo).|Placebo vs Darapladib 160 mg EC tablet: Mean vessel area|
1755198|NCT00268996|3224909|Superiority or Other||Adjusted Treatment Difference|2.627||||0.708|2-Sided|95.0|-11.171|16.425|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet once daily - Placebo).|For lumen volume|
1755199|NCT00268996|3224909|Superiority or Other||Adjusted treatment Difference|1.758||||0.811|2-Sided|95.0|-12.675|16.192|||ANCOVA||Difference in adjusted means are shown (Darapladib 160mg EC tablet once daily - Placebo).|For vessel volume|
1755200|NCT00268996|3224911|Superiority or Other||Adjusted percentage change|-8.585||||0.663|2-Sided|95.0|-39.007|37.012|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)|
1755201|NCT00268996|3224911|Superiority or Other||Adjusted percentage change|-0.252||||0.98|2-Sided|95.0|-18.151|21.561|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)|
1755202|NCT00268996|3224912|Superiority or Other||Adjusted percentage change|1.986||||0.818|2-Sided|95.0|-13.807|20.673|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)|
1755203|NCT00268996|3224912|Superiority or Other||Adjusted percentage change|-2.098||||0.79|2-Sided|95.0|-16.303|14.517|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)|
1755204|NCT00268996|3224913|Superiority or Other||Adjusted percentage change|38.567||||0.024|2-Sided|95.0|4.355|83.997|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52|
1755205|NCT00268996|3224913|Superiority or Other||Adjusted percentage change|15.449||||0.196|2-Sided|95.0|-7.204|43.632|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26|
1755206|NCT00268996|3224914|Superiority or Other||Adjusted percentage change|9.256||||0.252|2-Sided|95.0|-6.136|27.172|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 52 (LOCF)|
1755207|NCT00268996|3224914|Superiority or Other||Adjusted percentage change|16.725||||0.022|2-Sided|95.0|2.232|33.271|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)|
1755208|NCT00268996|3224915|Superiority or Other||Adjusted percentage change|-3.237||||0.29|2-Sided|95.0|-8.976|2.865|||ANOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100]||
1755209|NCT00268996|3224915|Superiority or Other||Adjusted percentage change|-1.112||||0.687|2-Sided|95.0|-6.363|4.433|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet once daily/Placebo) - 1 multiplied by 100]|Placebo vs Darapladib 160 mg EC tablet once daily at Week 26 (LOCF)|
1755210|NCT00268996|3224916|Superiority or Other||Adjusted percentage change|12.255||||0.247|2-Sided|95.0|-7.725|36.562|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100]|Week 52 (LOCF): Comparison between Placebo Vs Darapladib 160 mg EC tablet|
1755211|NCT00268996|3224916|Superiority or Other||Adjusted percentage change|6.958||||0.487|2-Sided|95.0|-11.568|29.364|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100]|Week 26 (LOCF): Comparison between Placebo vs Darapladib 160 mg EC tablet|
1755212|NCT00268996|3224917|Superiority or Other||Difference in adjusted means|-1.967||||0.047|2-Sided|95.0|-3.912|-0.022|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).||
1758393|NCT00205777|3229641|Superiority or Other|||||||0.76|||||||ANOVA||||
1755214|NCT00268996|3224919|Superiority or Other||Difference in adjusted means|-0.062||||0.898|2-Sided|95.0|-1.009|0.886|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).||
1755215|NCT00268996|3224920|Superiority or Other||Adjusted Treatment Difference|0.253||||0.945|2-Sided|95.0|-6.998|7.504|||ANCOVA||Difference in adjusted means are shown (Darapladib 160 mg EC tablet - Placebo).||
1755216|NCT00268996|3224921|Superiority or Other||Adjusted percentage change|-59.326|||<|0.001|2-Sided|95.0|-62.21|-56.222|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100]|Placebo vs Darapladib 160 mg EC tablet at Week 52 (LOCF)|
1755217|NCT00268996|3224921|Superiority or Other||Adjusted percentage change|-60.737|||<|0.001|2-Sided|95.0|-63.486|-57.78|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100]|Placebo vs Darapladib 160 mg EC tablet at Week 26 (LOCF)|
1755218|NCT00268996|3224922|Superiority or Other||Adjusted percentage change|3.977||||0.751|2-Sided|95.0|-18.331|32.379|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100]||
1755219|NCT00268996|3224923|Superiority or Other||Adjusted Treatment Difference|-0.082||||0.22|2-Sided|95.0|-0.214|0.049|||ANCOVA||Difference in adjusted means is shown (Darapladib 160 mg EC tablet - Placebo).||
1755220|NCT00268996|3224924|Superiority or Other||Adjusted percentage change|-11.717||||0.348|2-Sided|95.0|-31.995|14.607|||ANCOVA||Adjusted percentage change is shown [(Darapladib 160 mg EC tablet /Placebo) - 1 multiplied by 100]||
1755221|NCT00268346|3224965|Superiority or Other||percentage response|6.9|||<|0.05|2-Sided|95.0|||||binomial test for a single proportion|||In patients with prior chemotherapy, >25% response indicates efficacy and <10% indicates lack of efficacy. In patients with no prior chemotherapy, >45% response indicates efficacy and <25% indicates lack of efficacy. Using a 5% significance level, the study was designed to have 80% power to test each hypothesis.|
1755222|NCT00267969|3224980|Superiority or Other|||||||0.001||||||To control the overall multiplicity, the combined groups was tested first and each dose will then be tested; but the primary and the 1st 2 secondary endpoint analyses need to be significant before this endpoint can be tested|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [≤ 90kg vs > 90 kg)].||Null Hypothesis: No difference between combined maintenance group and the combined withdrawal group, ustekinumab 90 mg maintenance group and the withdrawal group, ustekinumab 45 mg maintenance group and the withdrawal group at an overall significance level of 0.05.|
1755223|NCT00267969|3224980|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [≤ 90kg vs > 90 kg)].|||
1755224|NCT00267969|3224980|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [≤ 90kg vs > 90 kg)].|||
1755225|NCT00267969|3224981|Superiority or Other||||||<|0.001||||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm’s procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first|ANOVA on van der Waerden normal scores|Treatment and patient's baseline weight (≤ 90kg vs > 90 kg) as factors in the model||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.|
1755226|NCT00267969|3224981|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores|Treatment and patient's baseline weight (≤ 90kg vs > 90 kg) as factors in the model|||
1755227|NCT00267969|3224982|Superiority or Other||||||<|0.001||||||To control the multiplicity for the primary and the secondary endpoint analyses, Holm’s procedure was used but the two comparisons for the primary endpoint and the two comparisons for the 1st second endpoint analyses need to be significant first|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [≤ 90kg vs > 90 kg)].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05.|
1755228|NCT00267969|3224982|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel(CMH) chi square|Stratified by baseline weight [≤ 90kg vs > 90 kg)].|||
1755229|NCT00267969|3224983|Superiority or Other||||||<|0.001||||||To control for the multiplicity for the primary endpoint analysis, the Holm’s procedure was used at an overall significance level of 0.05|Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [≤ 90kg vs > 90 kg)].||Null Hypothesis: No difference between ustekinumab 90 mg or 45 mg and placebo at an overall significance level of 0.05. Sample Size: With 750 patients (250 in each treatment group), simulation studies were conducted to calculate the power to detect a treatment difference in the primary endpoint between ustekinumab groups and placebo using a CMH test stratified by baseline weight [<=90kg vs > 90 kg). For all the scenarios evaluated, the power is >99% at an overall significance level of 0.05.|
1755230|NCT00267969|3224983|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel (CMH) chi square|Stratified by baseline weight [≤ 90kg vs > 90 kg)].|||
1755231|NCT00267956|3224984|Superiority or Other||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA on van der Waerden normal scores|Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.||Hypothesis: No difference between ustekinumab x 4 and placebo at asignificant level of 0.05.|
1755232|NCT00267956|3224985|Superiority or Other||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.|
1755233|NCT00267956|3224986|Superiority or Other||||||<|0.001||||||No multiplicity adjustment was made and nominal p-value was reported.|ANOVA on van der Waerden normal scores|Treatment and prior anti-TNF exposure (Yes/No) as factors in the model.||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.|
1755234|NCT00267956|3224987|Superiority or Other|||||||0.005||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05.|
1755235|NCT00267956|3224988|Superiority or Other|||||||0.004||||||No multiplicity adjustment was made and nominal p-value was reported.|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by participant's prior anti-TNF exposure status (Yes/No).||Hypothesis: No difference between Group II and Group I at a significant level of 0.05.|
1755328|NCT00266799|3225122|Superiority or Other|||||||0.1726|||||||Chi-squared|||By Investigator Assessment|
1755236|NCT00267956|3224989|Superiority or Other||||||<|0.001||||||The study is designed to maintain a Type I error of 0.05 or less for the primary analysis|Cochran-Mantel-Haenszel (CMH) chi-square|Stratified by subject’s prior anti-Tumor Necrosis Factor (TNF) exposure status (Yes/No).||Hypothesis: No difference between ustekinumab x 4 and placebo at a significant level of 0.05. Sample Size and power: With 70 partcipants in each treatment group, 5000 repetitions. Assuming a 20% ACR20 response in placebo participants regardless of prior anti-TNF exposure and a 35% ACR 20 and 45% ACR20 response in ustekinumab group for participants who had prior anti-TNF exposure, and who had no prior anti-TNF exposures, the power to detect the treatment difference is 0.85.|
1755237|NCT00267774|3224996|Other||||||<|0.0001||||||A 2-sided value of P<0.05 was considered to indicate statistical significance.|t-test, 2 sided||||
1755238|NCT00267748|3224998|Superiority or Other|||||||0.1967|||||||t-test, 2 sided|||P value was calculated using sample t-test.|
1755239|NCT00267748|3224999|Superiority or Other|||||||0.6737|||||||t-test, 2 sided|||P value was calculated using sample t-test.|
1755240|NCT00267748|3225000|Superiority or Other||Hazard Ratio (HR)|1.162||||0.365|2-Sided|95.0|0.838|1.612|||Log Rank|||For overall stratified analysis, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.|
1755241|NCT00267748|3225000|Superiority or Other||Hazard Ratio (HR)|1.238||||0.614|2-Sided|95.0|0.538|2.851|||Log Rank|||For low risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.|
1755242|NCT00267748|3225000|Superiority or Other||Hazard Ratio (HR)|1.169||||0.439|2-Sided|95.0|0.785|1.741|||Log Rank|||For intermediate risk factor,the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.|
1755243|NCT00267748|3225000|Superiority or Other||Hazard Ratio (HR)|1.071||||0.866|2-Sided|95.0|0.481|2.387|||Log Rank|||For high risk factor, the hazard ratio of OS was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median OS was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.|
1755244|NCT00267748|3225002|Superiority or Other||Mean Difference (Net)|4.11||||0.444|2-Sided|95.0|-6.4|14.6|||Chi-squared|||Response rate was estimated for each treatment group, 95% Confidence Interval (CI) on the difference in response rate between the 2 treatments was computed. P-value was calculated from a Pearson chi-square test.|
1755245|NCT00267748|3225003|Superiority or Other||Hazard Ratio (HR)|0.773||||0.09|2-Sided|95.0|0.572|1.044|||Log Rank|||For overall unstratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model. Two-sided unstratified Log rank method was used to calculate p value.|
1755246|NCT00267748|3225003|Superiority or Other||Hazard Ratio (HR)|0.827||||0.22|2-Sided|95.0|0.609|1.124|||Log Rank|||For overall stratified analysis, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.|
1755247|NCT00267748|3225003|Superiority or Other||Hazard Ratio (HR)|0.556||||0.075|2-Sided|95.0|0.288|1.074|||Log Rank|||For low risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.|
1755248|NCT00267748|3225003|Superiority or Other||Hazard Ratio (HR)|0.902||||0.583|2-Sided|95.0|0.623|1.306|||Log Rank|||For intermediate risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.|
1755249|NCT00267748|3225003|Superiority or Other||Hazard Ratio (HR)|1.089||||0.86|2-Sided|95.0|0.423|2.803|||Log Rank|||For High risk factor, the hazard ratio of TTP was estimated using stratified Cox Proportional Hazard model with the MSKCC prognostic factors (low, intermediate, high), used in the randomization, as a stratum and median TTP was estimated using Kaplan-Meier method. Log rank method was used to calculate p value.|
1755250|NCT00267670|3225006|Superiority or Other|||||||0.49|||||||t-test, 2 sided||||
1755251|NCT00267670|3225007|Superiority or Other|||||||0.94|||||||t-test, 2 sided||||
1755252|NCT00267670|3225008|Superiority or Other|||||||0.16|||||||t-test, 2 sided|||Null hypothesis was that there was no difference between mean hepatic expression of TNF-alpha receptors in patient with NASH. This was a secondary outcome and no power analysis was done.|
1755253|NCT00267670|3225009|Superiority or Other||Odds Ratio (OR)|1.0|Standard Error of the Mean|1.0||0.46|||||||ANOVA|||Sample size estimates were based on 30% reduction in ALT in the treatment group & 15% reduction in the placebo group. With a sample size of 30 planned (20 treatment:10 placebo), the study was designed to have a power of 90% to detect a difference in means of 1.25 standard deviations (ES=1.25), & a power of 80% to detect a difference in means of 1.1 standard deviations (ES=1.1), based on calculations using power index, z-table, & accounting for unequal sample size: n1 = 20, n2 = 10, a = 0.05.|
1755254|NCT00267631|3225012|Superiority or Other|||||||0.026|||||||Chi-squared||||
1755255|NCT00267293|3225019|Superiority or Other||||||<|0.0001||||||Binary outcome <38C and >=38C|Chi-squared||||
1755256|NCT00267293|3225019|Non-Inferiority or Equivalence|Power for 80%|||||<|0.001||||||comparision of mean temperatures from repeated exposure. At hour 6 temperature|Mixed Models Analysis|||Power for 80%|
1755257|NCT00267111|3225030|Superiority or Other||||||<|0.05||||||Statistical analyses were performed using SPSS v12, USA). Pain scores were compared between groups by means of the Student t-test. A p-value of < 0.05 was considered significant|t-test, 2 sided|||We hypothesized that parents and nurses will report lower pain scores as assessed by visual analogue scale in topical amethocaine gel 4% compared to placebo group. This was a secondary outcome and no power calculation was performed.|
1755258|NCT00267111|3225031|Superiority or Other||||||<|0.05||||||Statistical analyses were performed using SPSS v12, USA). Pain scores were compared between groups by means of the Student t-test. A p-value of < 0.05 was considered significant.|t-test, 2 sided|||We hypothesized that topical amethocaine gel 4% would reduce the pain from IM injection. The sample size was based on the pain scores obtained from a previous study that compared pain response during IM injection. To achieve a clinically significant reduction in pain scores by 20% between groups with 80% power and an alpha value of < 0.05, we estimated sample size of 49 neonates in each group. A total of 110 neonates were enrolled to account for possible dropouts and missing data.|
1755259|NCT00267098|3225032|Superiority or Other||Hazard Ratio (HR)|1.23||||0.189|2-Sided|95.0|0.78|2.01||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time from randomization to first ventricular arrhythmia occurring post-randomization for each subject. Ventricular arrhythmias occurring prior to randomization were excluded. A 95% credible interval was used.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, NYHA classifications of I-III, and indicated for defibrillation therapy who receive biventricular (BiV) pacing have the same rate of experiencing their first ventricular arrhythmia as corresponding patients who receive right ventricular pacing. This was tested against the one-side hypothesis that patients with BiV pacing have a lower risk of ventricular arrhythmias than subjects with right ventricular pacing.|
1755260|NCT00267098|3225034|Superiority or Other||Mean Difference (Final Values)|0.2069||||0.9983||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.|
1755261|NCT00267098|3225035|Superiority or Other||Mean Difference (Final Values)|0.1978||||0.9978||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.|
1755262|NCT00267098|3225036|Superiority or Other||Mean Difference (Final Values)|0.2503||||0.9999||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.|
1755263|NCT00267098|3225037|Superiority or Other||Mean Difference (Final Values)|0.1841||||0.9985||95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes, was calculated. A probability ≥ 0.95 was significant.|Posterior probability of mean difference|The posterior probability that the mean difference is greater than 0 was calculated.|This was a one-sided analysis of the BiV arm - RV arm difference in Mean Clinical Composite Scores. Values above 0 suggested better outcomes in the Biventricular arm.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar Clinical Composite Scores after 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients had better scores with BiV pacing than RV pacing. The analysis assigned numerical values (Improved=3, Unchanged=2, Worsened=1) and compared the average score between randomization arms using a one-sided analysis.|
1755264|NCT00267098|3225038|Superiority or Other||Posterior BiV - RV Mean Difference|0.11|||||2-Sided|95.0|-0.085|0.311|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.|
1755329|NCT00266799|3225123|Superiority or Other||Hazard Ratio (HR)|1.21||||0.4088|2-Sided|95.0|0.77|1.89|||Log Rank|||By RECIST Criteria of TTP Population|
1755330|NCT00266799|3225123|Superiority or Other||Hazard Ratio (HR)|1.14||||0.5508|2-Sided|95.0|0.74|1.77|||Log Rank|||By Investigator Assessment of TTP Population|
1758394|NCT00205777|3229641|Superiority or Other|||||||0.22|||||||ANOVA||||
1755265|NCT00267098|3225039|Superiority or Other||Posterior BiV - RV Mean Difference|0.041|||||2-Sided|95.0|-0.136|0.22|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.|
1755266|NCT00267098|3225040|Superiority or Other||Posterior BiV - RV Mean Difference|-0.117|||||2-Sided|95.0|-0.287|0.058|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.|
1755267|NCT00267098|3225041|Superiority or Other||Posterior BiV - RV Mean Difference|-0.047|||||2-Sided|95.0|-0.18|0.089|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean E/A change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in E:A ratio (E/A) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in E:A ratio through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.|
1755268|NCT00267098|3225042|Superiority or Other||Posterior BiV - RV Mean Difference|23.32|||||2-Sided|95.0|1.999|44.53|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value. A positive value reflected reduction in IVMD.|
1755269|NCT00267098|3225043|Superiority or Other||Posterior BiV - RV Mean Difference|26.53|||||2-Sided|95.0|6.247|47.19|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value. A positive value reflected reduction in IVMD.|
1755270|NCT00267098|3225044|Superiority or Other||Posterior BiV - RV Mean Difference|21.83|||||2-Sided|95.0|2.841|40.87|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value. A positive value reflected reduction in IVMD.|
1755271|NCT00267098|3225045|Superiority or Other||Posterior BiV - RV Mean Difference|29.3|||||2-Sided|95.0|10.04|48.64|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean IVMD change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in IVMD through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in IVMD through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value. A positive value reflected reduction in IVMD.|
1755272|NCT00267098|3225046|Superiority or Other||Posterior BiV - RV Mean Difference|0.047|||||2-Sided|95.0|-0.095|0.192|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.|
1755273|NCT00267098|3225047|Superiority or Other||Posterior BiV - RV Mean Difference|-0.081|||||2-Sided|95.0|-0.218|0.058|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.|
1755364|NCT00266409|3225197|Superiority or Other|||||||0.843||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1759148|NCT00191152|3230711|Superiority or Other|||||||0.377|||||||Log Rank||||
1755274|NCT00267098|3225048|Superiority or Other||Posterior BiV - RV Mean Difference|0.086|||||2-Sided|95.0|-0.022|0.198|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.|
1755275|NCT00267098|3225049|Superiority or Other||Posterior BiV - RV Mean Difference|0.08|||||2-Sided|95.0|-0.031|0.195|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean CI change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Cardiac Index (CI) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Cardiac Index through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.|
1755276|NCT00267098|3225050|Superiority or Other||Posterior BiV - RV Mean Difference|-0.653|||||2-Sided|95.0|-3.337|2.046|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.|
1755277|NCT00267098|3225051|Superiority or Other||Posterior BiV - RV Mean Difference|0.016|||||2-Sided|95.0|-2.379|2.425|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.|
1755278|NCT00267098|3225052|Superiority or Other||Posterior BiV - RV Mean Difference|-0.564|||||2-Sided|95.0|-2.843|1.773|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.|
1755279|NCT00267098|3225053|Superiority or Other||Posterior BiV - RV Mean Difference|-0.683|||||2-Sided|95.0|-2.828|1.506|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean MR change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in Mitral Regurgitation (MR) through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in Mitral Regurgitation through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.|
1755280|NCT00267098|3225054|Superiority or Other||Posterior BiV - RV Mean Difference|-0.18|||||2-Sided|95.0|-0.339|-0.018|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVESD.|
1755281|NCT00267098|3225055|Superiority or Other||Posterior BiV - RV Mean Difference|-0.06|||||2-Sided|95.0|-0.204|0.087|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVESD.|
1755282|NCT00267098|3225056|Superiority or Other||Posterior BiV - RV Mean Difference|-0.104|||||2-Sided|95.0|-0.236|0.029|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVESD.|
1755449|NCT00266409|3225239|Superiority or Other|||||||0.3535||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA||||
1755283|NCT00267098|3225057|Superiority or Other||Posterior BiV - RV Mean Difference|-0.066|||||2-Sided|95.0|-0.185|0.055|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESD change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVESD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVESD.|
1755284|NCT00267098|3225058|Superiority or Other||Posterior BiV - RV Mean Difference|-0.245|||||2-Sided|95.0|-0.39|-0.097|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 24 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 24 months than patients with RV pacing. Negative values reflect reductions in LVEDD.|
1755285|NCT00267098|3225059|Superiority or Other||Posterior BiV - RV Mean Difference|-0.163|||||2-Sided|95.0|-0.293|-0.03|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 18 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 18 months than patients with RV pacing. Negative values reflect reductions in LVEDD.|
1755286|NCT00267098|3225060|Superiority or Other||Posterior BiV - RV Mean Difference|-0.162|||||2-Sided|95.0|-0.287|-0.035|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 12 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 12 months than patients with RV pacing. Negative values reflect reductions in LVEDD.|
1755287|NCT00267098|3225061|Superiority or Other||Posterior BiV - RV Mean Difference|-0.126|||||2-Sided|95.0|-0.235|-0.014|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDD change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDD from randomization to 6 months as similar patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a different change in LVEDD from randomization to 6 months than patients with RV pacing. Negative values reflect reductions in LVEDD.|
1755288|NCT00267098|3225062|Superiority or Other||Posterior BiV - RV Mean Difference|-11.08|||||2-Sided|95.0|-21.11|-0.956|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 24 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 24 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 24 months with BiV pacing than RV pacing. Change was calculated as 24 month value - randomization visit value.|
1755289|NCT00267098|3225063|Superiority or Other||Posterior BiV - RV Mean Difference|-8.316|||||2-Sided|95.0|-18.19|1.623|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 18 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 18 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 18 months with BiV pacing than RV pacing. Change was calculated as 18 month value - randomization visit value.|
1755290|NCT00267098|3225064|Superiority or Other||Posterior BiV - RV Mean Difference|-10.16|||||2-Sided|95.0|-19.33|-0.857|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 12 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 12 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 12 months with BiV pacing than RV pacing. Change was calculated as 12 month value - randomization visit value.|
1755291|NCT00267098|3225065|Superiority or Other||Posterior BiV - RV Mean Difference|-3.894|||||2-Sided|95.0|-12.13|3.953|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LV Mass change through 6 months.|The null hypothesis is that patients with AV block, NYHA I-III, and LVEF of at most 50% who receive RV pacing have similar changes in LV Mass through 6 months compared to similar patients who receive BiV pacing. This was tested against the alternative hypothesis that patients have different changes in LV Mass through 6 months with BiV pacing than RV pacing. Change was calculated as 6 month value - randomization visit value.|
1755450|NCT00266409|3225240|Superiority or Other|||||||0.3618||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA||||
1755292|NCT00267098|3225066|Superiority or Other||Posterior BiV - RV Mean Difference|-6.615|||||2-Sided|95.0|-11.37|-1.736|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 24 months than patients with right ventricular pacing.|
1755293|NCT00267098|3225067|Superiority or Other||Posterior BiV - RV Mean Difference|-8.844|||||2-Sided|95.0|-12.91|-4.681|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 18 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 18 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 18 months than patients with right ventricular pacing."|
1755294|NCT00267098|3225068|Superiority or Other||Posterior BiV - RV Mean Difference|-5.807|||||2-Sided|95.0|-9.467|-2.038|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 12 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 12 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 12 months than patients with right ventricular pacing."|
1755295|NCT00267098|3225069|Superiority or Other||Posterior BiV - RV Mean Difference|-5.858|||||2-Sided|95.0|-9.085|-2.562|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEDVI change through 6 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEDVI from randomization to 6 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEDVI from randomization to 6 months than patients with right ventricular pacing.|
1755296|NCT00267098|3225070|Superiority or Other||Posterior BiV - RV Mean Difference|-7.268|||||2-Sided|95.0|-11.69|-2.846|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 24 months than patients with right ventricular pacing.|
1755297|NCT00267098|3225071|Superiority or Other||Posterior BiV - RV Mean Difference|-8.242|||||2-Sided|95.0|-11.86|-4.574|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 18 months than patients with right ventricular pacing.|
1755298|NCT00267098|3225072|Superiority or Other||Posterior BiV - RV Mean Difference|-7.255|||||2-Sided|95.0|-10.59|-3.829|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 12 months than patients with right ventricular pacing.|
1755299|NCT00267098|3225073|Superiority or Other||Posterior BiV - RV Mean Difference|-7.204|||||2-Sided|95.0|-10.12|-4.214|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVESVI change through 6 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVESVI from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVESVI from randomization to 6 months than patients with right ventricular pacing."|
1755300|NCT00267098|3225074|Superiority or Other||Posterior BiV - RV Mean Difference|3.623|||||2-Sided|95.0|1.623|5.604|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 24 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 24 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 24 months than patients with right ventricular pacing.|
1755301|NCT00267098|3225075|Superiority or Other||Posterior BiV - RV Mean Difference|2.24|||||2-Sided|95.0|0.419|4.066|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 18 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 18 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 18 months than patients with right ventricular pacing.|
1755302|NCT00267098|3225076|Superiority or Other||Posterior BiV - RV Mean Difference|3.232|||||2-Sided|95.0|1.618|4.839|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 12 months.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 12 months as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 12 months than patients with right ventricular pacing.|
1755303|NCT00267098|3225077|Superiority or Other||Posterior BiV - RV Mean Difference|3.334|||||2-Sided|95.0|1.886|4.815|||||Because Bayesian analyses were employed, a 95% two-sided credible interval was used instead of a confidence interval. This reflects the 2.5th and 97.5th percentile of possible values for the BiV-RV difference in mean LVEF change through 6 months.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in LVEF from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a different change in LVEF from randomization to 6 months than patients with right ventricular pacing."|
1755304|NCT00267098|3225078|Superiority or Other||Mean Difference (Final Values)|1.1||||0.727|2-Sided|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 24 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 24 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 24 months than patients with right ventricular pacing."|
1755305|NCT00267098|3225079|Superiority or Other||Mean Difference (Final Values)|1.8||||0.8416|2-Sided|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The parameter of interest was the BiV - RV difference in mean QOL change from randomization to 18 months.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 18 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 18 months than patients with right ventricular pacing."|
1755306|NCT00267098|3225080|Superiority or Other||Mean Difference (Final Values)|3.0||||0.9641|2-Sided|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 12 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 12 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 12 months than patients with right ventricular pacing."|
1755307|NCT00267098|3225081|Superiority or Other||Mean Difference (Final Values)|4.7||||0.9976|2-Sided|95.0||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Probability of Mean QOL Change|The posterior distribution for the BiV - RV difference in mean QOL score improvement from randomization to 6 months was determined.||"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same average change in QOL score from randomization to 6 months as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a greater reduction (and thus improvement) in QOL score at 6 months than patients with right ventricular pacing."|
1755308|NCT00267098|3225085|Superiority or Other||BiV - RV Difference in Average Rank|-0.006||||0.425|2-Sided|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 24 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values denote better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in HF stage from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.|
1755365|NCT00266409|3225197|Superiority or Other|||||||0.1247||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755309|NCT00267098|3225085|Superiority or Other||BiV - RV Difference in Average Rank|0.01||||0.651|2-Sided|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 18 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 18 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values denote that the BiV arm had better outcomes over time than the RV arm.|Subjects' changes in HF stage from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.|
1755310|NCT00267098|3225085|Superiority or Other||BiV - RV Difference in Average Rank|0.026||||0.825|2-Sided|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 12 month changes in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' change in HF stage from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.|
1755311|NCT00267098|3225085|Superiority or Other||BiV - RV Difference in Average Rank|0.002||||0.534|2-Sided|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 6 month change in HF Stage were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in HF stage from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.|
1755312|NCT00267098|3225086|Superiority or Other||BiV - RV Difference in Average Rank|0.035||||0.701|2-Sided|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 24 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 24 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 24 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.|
1755313|NCT00267098|3225086|Superiority or Other||BiV - RV Difference in Average Rank|0.039||||0.726|2-Sided|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 18 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 18 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.|
1755314|NCT00267098|3225086|Superiority or Other||BiV - RV Difference in Average Rank|0.126||||0.986|2-Sided|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability,representing the probability that subjects with biventricular pacing have better outcomes at 12 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 12 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 12 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.|
1755315|NCT00267098|3225086|Superiority or Other||BiV - RV Difference in Average Rank|0.012||||0.591|2-Sided|95.0||||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, a posterior probability, representing the probability that subjects with biventricular pacing have better outcomes at 6 months, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for Average Rank|Subjects' Randomization - 6 month changes in NYHA classification were ranked. The BiV - RV difference in average rank was analyzed.|Positive values reflect better outcomes over time in the BiV arm than the RV arm.|Subjects' changes in NYHA classification from randomization to 6 months were determined. The null hypothesis was that the average change among patients with biventricular pacing is equal to that of patients with right ventricular pacing.|
1755316|NCT00267098|3225087|Superiority or Other||BiV - RV Difference in Average Rank|-1.8||||0.637||||||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Difference in Average Ranks|The subjects' individual rates of days hospitalized for HF were ranked, with lower ranks corresponding to fewer days hospitalized for HF.|The posterior probability that the BiV - RV difference in average ranks was below 0 (denoting that the BiV arm had lower ranks than the RV arm, on average) was calculated.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of days hospitalized for heart failure per year as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of days hospitalized for HF than patients with right ventricular pacing.|
1755366|NCT00266409|3225198|Superiority or Other|||||||0.609||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755367|NCT00266409|3225198|Superiority or Other|||||||0.3252||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755486|NCT00265850|3225305|Superiority||Hazard Ratio (HR)|0.88||||0.08|2-Sided|95.0|0.77|1.01|||Log Rank||||
1755317|NCT00267098|3225088|Superiority or Other||Hazard Ratio (HR)|0.704||||0.9904|2-Sided|95.0|0.522|0.947||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of first heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of first HF hospitalization than patients with right ventricular pacing.|
1755318|NCT00267098|3225089|Superiority or Other||Hazard Ratio (HR)|0.695||||0.9886|2-Sided|95.0|0.558|0.866||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time from randomization to death or a visit in which LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.|"The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or II who receive biventricular pacing have the same rate of mortality or significant increase in LVESVI as corresponding patients who receive right ventricular pacing.~This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or significant increase in LVESVI than patients with right ventricular pacing."|
1755319|NCT00267098|3225090|Superiority or Other||Hazard Ratio (HR)|0.781||||0.9785|2-Sided|95.0|0.615|0.991||BLOCK HF is a Bayesian study; a p-value was not used. Instead, a posterior probability, representing the probability that patients with BiV pacing have better outcomes than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality or heart failure(HF)-related hospitalization as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with biventricular pacing have a lower rate of death or first HF hospitalization than patients with right ventricular pacing.|
1755320|NCT00267098|3225091|Superiority or Other||Hazard Ratio (HR)|0.843||||0.865|2-Sided|95.0|0.632|1.142||BLOCK HF is a Bayesian study; thus p-values were not used. Instead, posterior probabilities, representing the probability that subjects with biventricular pacing have better outcomes, were calculated. A probability ≥ 0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio for death can take, and its likelihood of taking such values.|Because BLOCK HF was a Bayesian study, a 95% credible interval was used in lieu of a 95% confidence interval. This interval reflects the set of values the Hazard Ratio can take with 95% posterior probability.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality as corresponding patients who receive right ventricular pacing.|
1755321|NCT00267098|3225092|Superiority or Other||Hazard Ratio (HR)|0.729||||0.999|2-Sided|95.0|0.592|0.889||BLOCK HF is a Bayesian study;a p-value was not used. Instead, a posterior probability,representing the probability that patients with BiV pacing have lower risk of events than those with RV pacing, was calculated. A probability ≥0.95 was significant.|Posterior Distribution for HR|The posterior distribution is the set of values the BiV to RV hazard ratio can take, and its likelihood of taking such values.|The hazard ratio corresponds to the time until death, a HF urgent care event or visit in which the LVESVI endpoint was met. Data beyond missed LVESVI measurements were excluded. A 95% credible interval was used instead of a 95% confidence interval.|The null hypothesis is that patients with AV block, ejection fractions of at most 50%, and NYHA classifications of I, II, or III who receive biventricular pacing have the same rate of mortality, a heart failure urgent care visit, or significant increase in LVESVI as corresponding patients who receive right ventricular pacing. This was tested against the hypothesis that patients with BiV pacing have a lower rate of this composite endpoint than patients with right ventricular pacing.|
1755322|NCT00267046|3225096|Superiority or Other||||||<|0.001|||||||Fine and Gray method.||||
1755323|NCT00266864|3225103|Superiority or Other||Mean Difference (Final Values)|101.0|Standard Deviation|103.0||0.051|2-Sided|95.0||||One sample t -tests were performed on the percent change from baseline to month 12 [(month 12– baseline)/baseline*100] for comparison to the null hypothesis. An a priori level of significance was set at p ≤ 0.05.|ANOVA|||Separate 2 factor (group: treatment, control) analysis of variance (ANOVA) with repeated measures on visit (baseline, month 12) were performed to identify changes in resting energy expenditure across time. To further characterize significant main and interaction effects, post-hoc paired t -tests were performed within group.|
1755324|NCT00266864|3225104|Superiority or Other||Mean Difference (Final Values)|3.4|Standard Deviation|2.7|<|0.01|2-Sided|95.0||||One sample t -tests were performed on the percent change from baseline to month 12 [(month 12– baseline)/baseline*100] for comparison to the null hypothesis. An a priori level of significance was set at p ≤ 0.05.|ANOVA|||Separate 2 factor (group: treatment, control) analysis of variance (ANOVA) with repeated measures on visit (baseline, month 12) were performed to identify changes in lean tissue mass across time. To further characterize significant main and interaction effects, post-hoc paired t -tests were performed within group.|
1755325|NCT00266799|3225120|Superiority or Other||Hazard Ratio (HR)|1.29||||0.0841||95.0|||||Log Rank|p-value also given for Hazard Ratio|||
1755326|NCT00266799|3225121|Superiority or Other||Hazard Ratio (HR)|1.12||||0.5265|2-Sided|95.0|0.79|1.58|||Log Rank||||
1755327|NCT00266799|3225122|Superiority or Other|||||||0.6541|||||||Chi-squared|||By RECIST Criteria|
1755331|NCT00266799|3225123|Non-Inferiority or Equivalence|"Non-inferiority was tested using the upper limit of the 95% CI for the hazard ratio as quantitative estimate of the minimum effect of PLD relative to capecitabine. Margin for non-inferiority was set to 1.143, reflecting an acceptable difference in TTP of 0.75 months assuming an expected median TTP of up to 6 months with the comparator. If the estimate was below margin, PLD was to be considered non-inferior to capecitabine assuming sufficient sensitivity to detect the drug effects of~interest."|Hazard Ratio (HR)|1.15||||0.4472|2-Sided|95.0|0.8|1.65|||Log Rank|||By RECIST Criteria of ITT Population|
1755332|NCT00266799|3225123|Non-Inferiority or Equivalence|"Non-inferiority was tested using the upper limit of the 95% CI for the hazard ratio as quantitative estimate of the minimum effect of PLD relative to capecitabine. Margin for non-inferiority was set to 1.143, reflecting an acceptable difference in TTP of 0.75 months assuming an expected median TTP of up to 6 months with the comparator. If the estimate was below margin, PLD was to be considered non-inferior to capecitabine assuming sufficient sensitivity to detect the drug effects of~interest."|Hazard Ratio (HR)|1.08||||0.6686|2-Sided|95.0|0.76|1.54|||Log Rank|||By Investigator Assessment of ITT Population|
1755333|NCT00266630|3225173|Superiority or Other||Mean Difference (Final Values)|-19.8|||||2-Sided|95.0|-25.58|-14.06|||||||
1755334|NCT00266630|3225177|Superiority or Other||Mean Difference (Final Values)|-3.0|||||2-Sided|95.0|-4.1|-1.9|||||||
1755335|NCT00266409|3225178|Superiority or Other|||||||0.6587|||||||Generalized Wilcoxon Test|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.|
1755336|NCT00266409|3225178|Superiority or Other|||||||0.044|||||||Generalized Wilcoxon Test|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.|
1755337|NCT00266409|3225179|Superiority or Other|||||||0.5824|||||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack|
1755338|NCT00266409|3225180|Superiority or Other|||||||0.3093|||||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack|
1755339|NCT00266409|3225181|Superiority or Other|||||||0.9883|||||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack|
1755340|NCT00266409|3225182|Superiority or Other|||||||0.9375||||||P-value from a Chi-squared test|Chi-squared||||
1755341|NCT00266409|3225183|Superiority or Other|||||||0.1447|||||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack|
1755342|NCT00266409|3225184|Superiority or Other|||||||0.5271|||||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack|
1755343|NCT00266409|3225185|Superiority or Other|||||||0.9269|||||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack|
1755344|NCT00266409|3225186|Superiority or Other|||||||0.5544|||||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack|
1755345|NCT00266409|3225187|Superiority or Other|||||||0.6602|||||||Chi-squared|||test of difference in percentage of subjects reporting any panic attack|
1755346|NCT00266409|3225188|Superiority or Other|||||||0.1281||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755347|NCT00266409|3225188|Superiority or Other|||||||0.2184||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755348|NCT00266409|3225189|Superiority or Other|||||||0.2924||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755349|NCT00266409|3225189|Superiority or Other|||||||0.445||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755350|NCT00266409|3225190|Superiority or Other|||||||0.393||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755351|NCT00266409|3225190|Superiority or Other|||||||0.4589||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755352|NCT00266409|3225191|Superiority or Other|||||||0.6182||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755353|NCT00266409|3225191|Superiority or Other|||||||0.1244||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755354|NCT00266409|3225192|Superiority or Other|||||||0.1935||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755355|NCT00266409|3225192|Superiority or Other|||||||0.1164||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755356|NCT00266409|3225193|Superiority or Other|||||||0.0422||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755357|NCT00266409|3225193|Superiority or Other|||||||0.2186||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755358|NCT00266409|3225194|Superiority or Other|||||||0.5375||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755359|NCT00266409|3225194|Superiority or Other|||||||0.8318||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755360|NCT00266409|3225195|Superiority or Other|||||||0.0871||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755361|NCT00266409|3225195|Superiority or Other|||||||0.0508||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755362|NCT00266409|3225196|Superiority or Other|||||||0.0543||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755363|NCT00266409|3225196|Superiority or Other|||||||0.1031||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A somatic subscore as a covariate|ANCOVA||||
1755368|NCT00266409|3225199|Superiority or Other|||||||0.9427||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755369|NCT00266409|3225199|Superiority or Other|||||||0.3174||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755370|NCT00266409|3225200|Superiority or Other|||||||0.3125||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755371|NCT00266409|3225200|Superiority or Other|||||||0.255||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755372|NCT00266409|3225201|Superiority or Other|||||||0.4672||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755373|NCT00266409|3225201|Superiority or Other|||||||0.3539||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755374|NCT00266409|3225202|Superiority or Other|||||||0.0936||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755375|NCT00266409|3225202|Superiority or Other|||||||0.828||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755376|NCT00266409|3225203|Superiority or Other|||||||0.9651||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755377|NCT00266409|3225203|Superiority or Other|||||||0.7896||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755378|NCT00266409|3225204|Superiority or Other|||||||0.0852||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755379|NCT00266409|3225204|Superiority or Other|||||||0.0932||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755380|NCT00266409|3225205|Superiority or Other|||||||0.1641||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A psychic factors subscore as a covariate|ANCOVA||||
1755381|NCT00266409|3225205|Superiority or Other|||||||0.0075||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A psychic factors subscore as a covariate|ANCOVA||||
1755382|NCT00266409|3225206|Superiority or Other|||||||0.4639||||||P-values based on an ANCOVA with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755383|NCT00266409|3225206|Superiority or Other|||||||0.0722||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755384|NCT00266409|3225207|Superiority or Other|||||||0.5461||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755385|NCT00266409|3225207|Superiority or Other|||||||0.393||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755386|NCT00266409|3225208|Superiority or Other|||||||0.2513||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755387|NCT00266409|3225208|Superiority or Other|||||||0.3827||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755388|NCT00266409|3225209|Superiority or Other|||||||0.2709||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755389|NCT00266409|3225209|Superiority or Other|||||||0.9346||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAMA-A insomnia subscore as a covariate|ANCOVA||||
1755390|NCT00266409|3225210|Superiority or Other|||||||0.1148||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755391|NCT00266409|3225210|Superiority or Other|||||||0.7434||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755392|NCT00266409|3225211|Superiority or Other|||||||0.1354||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755393|NCT00266409|3225211|Superiority or Other|||||||0.9093||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755394|NCT00266409|3225212|Superiority or Other|||||||0.5502||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755395|NCT00266409|3225212|Superiority or Other|||||||0.4648||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755396|NCT00266409|3225213|Superiority or Other|||||||0.0122||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755397|NCT00266409|3225213|Superiority or Other|||||||0.5153||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755398|NCT00266409|3225214|Superiority or Other|||||||0.0273||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755399|NCT00266409|3225214|Superiority or Other|||||||0.0677||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline HAM-A insomnia subscore as a covariate|ANCOVA||||
1755400|NCT00266409|3225215|Superiority or Other|||||||0.2541|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755447|NCT00266409|3225238|Superiority or Other|||||||0.3414||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA||||
1755401|NCT00266409|3225215|Superiority or Other|||||||0.0419|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755402|NCT00266409|3225216|Superiority or Other|||||||0.3196|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755403|NCT00266409|3225216|Superiority or Other|||||||0.1705|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755404|NCT00266409|3225217|Superiority or Other|||||||0.5533|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755405|NCT00266409|3225217|Superiority or Other|||||||0.6323|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755406|NCT00266409|3225218|Superiority or Other|||||||0.0029|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint.CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755407|NCT00266409|3225218|Superiority or Other|||||||0.1196|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755408|NCT00266409|3225219|Superiority or Other|||||||0.0376|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755409|NCT00266409|3225219|Superiority or Other|||||||0.0761|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755410|NCT00266409|3225220|Superiority or Other|||||||0.1024|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755411|NCT00266409|3225220|Superiority or Other|||||||0.016|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755412|NCT00266409|3225221|Superiority or Other|||||||0.039|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755413|NCT00266409|3225221|Superiority or Other|||||||0.0095|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755414|NCT00266409|3225222|Superiority or Other|||||||0.0101|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755415|NCT00266409|3225222|Superiority or Other|||||||0.0025|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755416|NCT00266409|3225223|Superiority or Other|||||||0.0003|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755448|NCT00266409|3225239|Superiority or Other|||||||0.566||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA||||
1755487|NCT00265616|3225324|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1755417|NCT00266409|3225223|Superiority or Other|||||||0.0001|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755418|NCT00266409|3225224|Superiority or Other|||||||0.7096|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755419|NCT00266409|3225224|Superiority or Other|||||||0.0978|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755420|NCT00266409|3225225|Superiority or Other|||||||0.9569|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755421|NCT00266409|3225225|Superiority or Other|||||||0.037|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755422|NCT00266409|3225226|Superiority or Other|||||||0.0065|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755423|NCT00266409|3225226|Superiority or Other|||||||0.0255|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint, CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755424|NCT00266409|3225227|Superiority or Other|||||||0.0006|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755425|NCT00266409|3225227|Superiority or Other|||||||0.0002|||||||van Elteren test|||van Elteren test stratified by CGI-Severity score at baseline and testing between treatment differences in percentages based on non-missing responses within a timepoint. CGI-Severity score categorizes severity at baseline as normal,not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill.|
1755426|NCT00266409|3225228|Superiority or Other|||||||0.9096|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755427|NCT00266409|3225228|Superiority or Other|||||||0.5836|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755428|NCT00266409|3225229|Superiority or Other|||||||0.7555|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755429|NCT00266409|3225229|Superiority or Other|||||||0.8617|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755430|NCT00266409|3225230|Superiority or Other|||||||0.9629|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755431|NCT00266409|3225230|Superiority or Other|||||||0.6946|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755432|NCT00266409|3225231|Superiority or Other|||||||0.8263|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755433|NCT00266409|3225231|Superiority or Other|||||||0.6404|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755434|NCT00266409|3225232|Superiority or Other|||||||0.8196|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755435|NCT00266409|3225232|Superiority or Other|||||||0.6501|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755436|NCT00266409|3225233|Superiority or Other|||||||0.0897|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755437|NCT00266409|3225233|Superiority or Other|||||||0.7338|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755438|NCT00266409|3225234|Superiority or Other|||||||0.7729|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755439|NCT00266409|3225234|Superiority or Other|||||||0.9988|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755440|NCT00266409|3225235|Superiority or Other|||||||0.5369|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755441|NCT00266409|3225235|Superiority or Other|||||||0.2645|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755442|NCT00266409|3225236|Superiority or Other|||||||0.4205|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755443|NCT00266409|3225236|Superiority or Other|||||||0.035|||||||Chi-squared|||Analysis refers to test of differences in response rates.|
1755444|NCT00266409|3225237|Superiority or Other|||||||0.4416||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA||||
1755445|NCT00266409|3225237|Superiority or Other|||||||0.1197||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA||||
1755446|NCT00266409|3225238|Superiority or Other|||||||0.7344||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA||||
1755451|NCT00266409|3225240|Superiority or Other|||||||0.1456||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA||||
1755452|NCT00266409|3225241|Superiority or Other|||||||0.2187||||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as covariate|ANCOVA||||
1755453|NCT00266409|3225241|Superiority or Other|||||||0.182||||||P-value based on an ANCOVA model with treatment as a fixed effect and total HAM-A score as a covariate|ANCOVA||||
1755454|NCT00266409|3225242|Superiority or Other|||||||0.0231||||||P-value based on ANCOVA with treatment as a fixed effect and baseline HAM-A score as a covariate|ANCOVA||||
1755455|NCT00266409|3225242|Superiority or Other|||||||0.4261||||||P-value based on an ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA||||
1755456|NCT00266409|3225243|Superiority or Other|||||||0.6735||||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA||||
1755457|NCT00266409|3225243|Superiority or Other|||||||0.739||||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA||||
1755458|NCT00266409|3225244|Superiority or Other|||||||0.0366||||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA||||
1755459|NCT00266409|3225244|Superiority or Other|||||||0.0361||||||P-value based on ANCOVA model with treatment as a fixed effect and baseline total HAM-A score as a covariate|ANCOVA||||
1755460|NCT00266409|3225245|Superiority or Other|||||||0.0516|||||||ANCOVA|||ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate|
1755461|NCT00266409|3225245|Superiority or Other|||||||0.0173|||||||ANCOVA|||ANCOVA with treatment as a fixed effect and baseline total HAM-A score as a covariate|
1755462|NCT00266409|3225246|Superiority or Other|||||||0.4544|||||||Generalized Wilcoxon|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.|
1755463|NCT00266409|3225246|Superiority or Other|||||||0.1143|||||||Generalized Wilcoxon|||This analysis refers to the test of the null hypothesis that there is no difference in the survival distribution function between the treatment groups.|
1755464|NCT00266227|3225266|Superiority or Other||Mean Difference (Final Values)|-0.4||||||95.0|-0.7|-0.1||||||Assessed using an analysis of variance (ANOVA) model, with retreatment group, baseline DAS28-ESR score, baseline RF status, and ≥20% improvement in both SJC and TJC at Week 24 from baseline (yes/no) as explanatory terms in the model.|
1755465|NCT00266227|3225268|Superiority or Other|||||||0.0195|||||||Cochran-Mantel-Haenszel||||
1755466|NCT00266032|3225283|Superiority or Other||Mean Difference (Final Values)|-25.0|Standard Deviation|29.0|<|0.0001||95.0|-29.0|-20.0|||t-test, 2 sided||Mean of Yaz flexible regimen minus mean of Yaz standard was tested|Primary variable was tested for the hypothesis, whether the means are equal against the alternative (means are different) at a level of significance of alpha = 0.05 (t-test). For power calculation, a normal distribution, a absolute difference of 10 days, a Standard Deviation of 28 days and a drop-out rate of 40% was assumed.|
1755467|NCT00265941|3225287|Superiority||Hazard Ratio (HR)|0.31||||0.04|2-Sided|95.0|0.1|0.97|||Log Rank|2-sided significance level = 0.05|Reference level = low|Loco-regional control (LRC) is compared between low and high SUVmax groups.|
1755468|NCT00265941|3225287|Superiority||Hazard Ratio (HR)|0.38||||0.1|2-Sided|95.0|0.12|1.2|||Log Rank|2-sided significance level = 0.05|Reference level = low|Overall survival (OS) is compared between low and high SUVmax groups.|
1755469|NCT00265941|3225287|Superiority||Hazard Ratio (HR)|0.3||||0.01|2-Sided|95.0|0.12|0.75|||Log Rank|2-sided significance level = 0.05|Reference level = low|Progression-free survival is compared between low and high SUVmax groups.|
1755470|NCT00265941|3225288|Superiority||Hazard Ratio (HR)|0.93||||0.76|2-Sided|95.0|0.6|1.46|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Local-regional failure|
1755471|NCT00265941|3225288|Superiority||Hazard Ratio (HR)|1.19||||0.37|2-Sided|95.0|0.81|1.76|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Overall survival is compared between favorable risk and unfavorable risk groups.|
1755472|NCT00265941|3225288|Superiority||Hazard Ratio (HR)|1.09||||0.6|2-Sided|95.0|0.79|1.51|||Log Rank|2-sided significance level = 0.05|Reference level = low EGFR|Progression-free survival is compared between favorable risk and unfavorable risk groups.|
1755473|NCT00265941|3225289|Superiority|||||||0.016|||||||t-test, 2 sided|2-sided significance level of 0.05|||
1755474|NCT00265941|3225290|Superiority|||||||0.67|||||||Chi-squared|2-sided significance level of 0.05||Speech 12-month|
1755475|NCT00265941|3225290|Superiority|||||||0.81|||||||Chi-squared|2-sided significance level of 0.05||Speech 3-month|
1755476|NCT00265941|3225290|Superiority|||||||0.16|||||||Chi-squared|2-sided significance level of 0.05||Eating 12-month|
1755477|NCT00265941|3225290|Superiority|||||||0.39|||||||Chi-squared|2-sided significance level of 0.05||Eating 3-month|
1755478|NCT00265941|3225290|Superiority|||||||0.87|||||||Chi-squared|2-sided significance level 0.05||Diet 12-month|
1755479|NCT00265941|3225290|Superiority|||||||0.13|||||||Chi-squared|2-sided significance level of 0.05||Diet 3-month|
1755480|NCT00265941|3225291|Superiority|||||||0.99|||||||Kolmogorov-Smirnov|2-sided significance level of 0.05||12 months|
1755481|NCT00265941|3225291|Superiority|||||||0.74|||||||Kolmogorov-Smirnov|2-sided significance level of 0.05||3 months|
1755482|NCT00265941|3225296|Superiority||Hazard Ratio (HR)|1.3||||0.97|2-Sided|95.0|0.99|1.7|||Log Rank|One-sided significance level of 0.025|Reference level = RT + cisplatin||
1755483|NCT00265941|3225297|Superiority||Hazard Ratio (HR)|0.95||||0.32|2-Sided|95.0|0.74|1.21|||Log Rank|One-sided log-rank significance level of 0.025|Reference level = RT + cisplatin|Arms were compared using a one-sided log-rank test at the 0.025 significance level.|
1755484|NCT00265941|3225298|Superiority||Hazard Ratio (HR)|1.08||||0.76|2-Sided|95.0|0.88|1.32|||Log Rank||Reference arm = RT + cisplatin|A total of 945 patients were required (900 analyzable) to test for a 25% reduction in the hazard associated with progression-free survival with 84% statistical power using a one-sided log-rank test at the 0.025 significance level (0.0238 after 3 interim analyses).|
1755485|NCT00265850|3225304|Superiority||Hazard Ratio (HR)|0.95||||0.45|2-Sided|95.0|0.84|1.08|||Log Rank||||
1755498|NCT00265317|3225385|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||sKIT Ratio to Baseline for Cycle 2, Day 1|
1755499|NCT00265317|3225387|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-3 Ratio to Baseline for Cycle 3, Day 1|
1755500|NCT00265317|3225387|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-3 Ratio to Baseline for Cycle 2, Day 1|
1755501|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.874||||0.3263|2-Sided|95.0|0.501|1.523||1-sided unstratified log-rank test|Log Rank|||Indeterminate RET expression|
1755502|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.874||||0.3723|2-Sided|95.0|0.358|2.13||1-sided unstratified log-rank test|Log Rank|||No detected RET expression|
1755503|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.693||||0.3757|2-Sided|95.0|0.071|6.765||1-sided unstratified log-rank test|Log Rank|||Detected RET expression|
1755504|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.896||||0.3597|2-Sided|95.0|0.502|1.598||1-sided unstratified log-rank test|Log Rank|||Indeterminate KIT expression|
1755505|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.677||||0.199|2-Sided|95.0|0.265|1.731||1-sided unstratified log-rank test|Log Rank|||Participants with no detected KIT expression|
1755506|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|1.342||||0.6907|2-Sided|95.0|0.419|4.297||1-sided unstratified log-rank test|Log Rank|||Detected KIT expression|
1755507|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.896||||0.3597|2-Sided|95.0|0.502|1.598||1-sided unstratified log-rank test|Log Rank|||Indeterminate FLT3 expression|
1755508|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.838||||0.3266|2-Sided|95.0|0.375|1.876||1-sided unstratified log-rank test|Log Rank|||No detected FLT3 expression|
1755509|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|1.406||||0.6504|2-Sided|95.0|0.248|7.96||1-sided unstratified log-rank test|Log Rank|||Detected FLT3 expression|
1755510|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.844||||0.2812|2-Sided|95.0|0.486|1.465||1-sided unstratified log-rank test|Log Rank|||Indeterminate FGF expression|
1755511|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|1.316||||0.7143|2-Sided|95.0|0.526|3.292||1-sided unstratified log-rank test|Log Rank|||No detected FGF expression|
1755512|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.446||||0.2321|2-Sided|95.0|0.048|4.101||1-sided unstratified log-rank test|Log Rank|||Detected FGF expression|
1755513|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.818||||0.2432|2-Sided|95.0|0.473|1.414||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR3 expression|
1755514|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|1.005||||0.4887|2-Sided|95.0|0.334|3.025||1-sided unstratified log-rank test|Log Rank|||Low VEGFR3 expression|
1755515|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|1.002||||0.5015|2-Sided|95.0|0.281|3.581||1-sided unstratified log-rank test|Log Rank|||High VEGFR3 expression|
1755516|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.864||||0.3147|2-Sided|95.0|0.489|1.528||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR2 expression|
1755517|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|1.122||||0.5699|2-Sided|95.0|0.403|3.125||1-sided unstratified log-rank test|Log Rank|||Low VEGFR2 expression|
1755518|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.921||||0.4438|2-Sided|95.0|0.304|2.784||1-sided unstratified log-rank test|Log Rank|||High VEGFR2 expression|
1755519|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.902||||0.3605|2-Sided|95.0|0.53|1.537||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGFR1 expression|
1755520|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.599||||0.2132|2-Sided|95.0|0.16|2.236||1-sided unstratified log-rank test|Log Rank|||Low VEGFR1 expression|
1755521|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|1.097||||0.5605|2-Sided|95.0|0.331|3.636||1-sided unstratified log-rank test|Log Rank|||High VEGFR1 expression|
1755522|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.875||||0.3301|2-Sided|95.0|0.493|1.554||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGF-C expression|
1755523|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.842||||0.3652|2-Sided|95.0|0.313|2.266||1-sided unstratified log-rank test|Log Rank|||Low VEGF-C expression|
1755524|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|1.09||||0.5586|2-Sided|95.0|0.35|3.397||1-sided unstratified log-rank test|Log Rank|||High VEGF-C expression|
1755525|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.911||||0.372|2-Sided|95.0|0.536|1.548||1-sided unstratified log-rank test|Log Rank|||Indeterminate VEGF expression|
1755526|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.953||||0.4582|2-Sided|95.0|0.296|3.062||1-sided unstratified log-rank test|Log Rank|||Low VEGF expression|
1755527|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.914||||0.4436|2-Sided|95.0|0.262|3.184||1-sided unstratified log-rank test|Log Rank|||High VEGF expression|
1755528|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.856||||0.3027|2-Sided|95.0|0.488|1.502||1-sided unstratified log-rank test|Log Rank|||Indeterminate PDGFRbeta expression|
1755529|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|1.192||||0.6105|2-Sided|95.0|0.408|3.48||1-sided unstratified log-rank test|Log Rank|||Low PDGFRbeta expression|
1755530|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.823||||0.365|2-Sided|95.0|0.273|2.488||1-sided unstratified log-rank test|Log Rank|||High PDGFRbeta expression|
1755531|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.862||||0.3128|2-Sided|95.0|0.487|1.524||1-sided unstratified log-rank test|Log Rank|||Indeterminate PDGFRalpha expression|
1755532|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.386||||0.0401|2-Sided|95.0|0.127|1.173||1-sided unstratified log-rank test|Log Rank|||Low PDGFRalpha expression|
1755533|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|2.687||||0.9497|2-Sided|95.0|0.79|9.143||1-sided unstratified log-rank test|Log Rank|||High PDGFRalpha expression|
1755534|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.89||||0.3498|2-Sided|95.0|0.503|1.574||1-sided unstratified log-rank test|Log Rank|||Indeterminate CSF-1R expression|
1757159|NCT00241904|3227579|Superiority||||||<|0.001|||||||General Linear Mixed Model|||Intention to treat analysis was used|
1755535|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|1.451||||0.7688|2-Sided|95.0|0.534|3.944||1-sided unstratified log-rank test|Log Rank|||Low CSF-1R expression|
1755536|NCT00265317|3225388|Superiority or Other||Hazard Ratio (HR)|0.553||||0.1667|2-Sided|95.0|0.159|1.921||1-sided unstratified log-rank test|Log Rank|||High CSF-1R expression|
1755537|NCT00265317|3225389|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-2 Ratio to Baseline for Cycle 3, Day 1|
1755538|NCT00265317|3225389|Superiority or Other||||||<|0.0001|||||||Wilcoxon Rank Sum Test|||VEGFR-2 Ratio to Baseline for Cycle 2, Day 1|
1755539|NCT00265317|3225391|Superiority or Other|||||||0.7354|||||||Wilcoxon Rank Sum Test|||VEGF-C ratio to Baseline for Cycle 3, Day 1|
1755540|NCT00265317|3225391|Superiority or Other|||||||0.2702|||||||Wilcoxon Rank Sum Test|||VEGF-C Ratio to Baseline for Cycle 2, Day 1|
1755541|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.607||||0.534|2-Sided|95.0|0.117|3.158||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: A/A|
1755542|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.867||||0.7097|2-Sided|95.0|0.406|1.848||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/A|
1755543|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.274||||0.4663|2-Sided|95.0|0.661|2.457||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/G|
1755544|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|4.85||||0.012|2-Sided|95.0|1.253|18.78||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/A|
1755545|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.752||||0.2755|2-Sided|95.0|0.45|1.259||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/G|
1755546|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.331||||0.0996|2-Sided|95.0|0.082|1.339||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: G/G|
1755547|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.793||||0.5259|2-Sided|95.0|0.384|1.636||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/G|
1755548|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.613||||0.1911|2-Sided|95.0|0.781|3.332||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/A|
1755549|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.411||||0.1495|2-Sided|95.0|0.119|1.423||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/A|
1755550|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.263||||0.3698|2-Sided|95.0|0.755|2.113||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/T|
1755551|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.721||||0.3132|2-Sided|95.0|0.59|5.021||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/A|
1755552|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.854||||0.5544|2-Sided|95.0|0.504|1.447||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/G|
1755553|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.449||||0.1365|2-Sided|95.0|0.152|1.331||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: G/G|
1755554|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.088||||0.7931|2-Sided|95.0|0.577|2.052||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/G|
1755555|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.779||||0.2552|2-Sided|95.0|0.652|4.855||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/T|
1755556|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.232||||0.6614|2-Sided|95.0|0.483|3.142||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: A/A|
1755557|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.123||||0.75|2-Sided|95.0|0.549|2.297||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/A|
1755558|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.758||||0.5233|2-Sided|95.0|0.322|1.782||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/G|
1755559|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.129||||0.8501|2-Sided|95.0|0.316|4.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: T/T|
1755560|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.112||||0.7677|2-Sided|95.0|0.549|2.252||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/T|
1755561|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.973||||0.9419|2-Sided|95.0|0.466|2.032||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/C|
1755562|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.02||||0.9702|2-Sided|95.0|0.36|2.891||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/G|
1755563|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.996||||0.9888|2-Sided|95.0|0.59|1.681||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/T|
1755564|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.039||||0.8708|2-Sided|95.0|0.654|1.652||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs34586048 Genotype: C/C|
1755565|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|3.672||||0.0091|2-Sided|95.0|1.291|10.44||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/C|
1755566|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.692||||0.1859|2-Sided|95.0|0.399|1.2||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/T|
1755567|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.286||||0.1299|2-Sided|95.0|0.051|1.596||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/A|
1755568|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.229||||0.4118|2-Sided|95.0|0.749|2.017||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/G|
1755569|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.129||||0.8501|2-Sided|95.0|0.316|4.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: A/A|
1755570|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.053||||0.8842|2-Sided|95.0|0.526|2.106||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/A|
1755837|NCT00264147|3225541|Superiority or Other||difference in percentage of patients|18.53||||||95.0|7.84|28.65|||||CI based on the Wilson's score method.||
1755571|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.035||||0.9287|2-Sided|95.0|0.487|2.199||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/G|
1755572|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.758||||0.598|2-Sided|95.0|0.268|2.141||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: C/C|
1755573|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.076||||0.8335|2-Sided|95.0|0.541|2.141||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/C|
1755574|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.106||||0.81|2-Sided|95.0|0.485|2.525||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/G|
1755575|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.769||||0.6703|2-Sided|95.0|0.229|2.58||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: G/G|
1755576|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.227||||0.6003|2-Sided|95.0|0.567|2.656||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/G|
1755577|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.984||||0.963|2-Sided|95.0|0.491|1.972||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/A|
1755578|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|2.32||||0.3272|2-Sided|95.0|0.412|13.07||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: T/T|
1755579|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.938||||0.8531|2-Sided|95.0|0.472|1.863||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/T|
1755580|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.908||||0.7836|2-Sided|95.0|0.456|1.809||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/A|
1755581|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.364||||0.4168|2-Sided|95.0|0.641|2.9||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/A|
1755582|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.793||||0.4657|2-Sided|95.0|0.424|1.483||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/G|
1755583|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|2.732||||0.3657|2-Sided|95.0|0.283|26.42||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: T/T|
1755584|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.067||||0.8536|2-Sided|95.0|0.536|2.122||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/T|
1755585|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.875||||0.6945|2-Sided|95.0|0.449|1.708||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/C|
1755586|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|0.897||||0.8066|2-Sided|95.0|0.375|2.147||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs234060 Genotype: A/A|
1755587|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.111||||0.7375|2-Sided|95.0|0.599|2.064||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/A|
1755588|NCT00265317|3225394|Superiority or Other||Hazard Ratio (HR)|1.121||||0.8563|2-Sided|95.0|0.326|3.847||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/C|
1755589|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|1.155||||0.9191|2-Sided|95.0|0.072|18.59||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: A/A|
1755590|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.634||||0.2445|2-Sided|95.0|0.287|1.401||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/A|
1755591|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.935||||0.8478|2-Sided|95.0|0.47|1.861||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2302273 Genotype: G/G|
1755592|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|1.114||||0.8586|2-Sided|95.0|0.339|3.667||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/A|
1755593|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.662||||0.1373|2-Sided|95.0|0.381|1.153||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2007637 Genotype: G/G|
1755594|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.531||||0.3844|2-Sided|95.0|0.125|2.282||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: G/G|
1755595|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.976||||0.948|2-Sided|95.0|0.47|2.028||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/G|
1755596|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.687||||0.3286|2-Sided|95.0|0.321|1.473||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776081 Genotype: A/A|
1755597|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|1.192||||0.7725|2-Sided|95.0|0.36|3.946||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/A|
1755598|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.652||||0.1145|2-Sided|95.0|0.378|1.122||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs10063714 Genotype: T/T|
1755599|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.987||||0.9802|2-Sided|95.0|0.353|2.759||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/A|
1755600|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.704||||0.2168|2-Sided|95.0|0.4|1.239||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17708574 Genotype: G/G|
1755601|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.475||||0.2625|2-Sided|95.0|0.125|1.813||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: G/G|
1755602|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.839||||0.5931|2-Sided|95.0|0.436|1.618||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/G|
1755603|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.809||||0.6652|2-Sided|95.0|0.308|2.124||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3776075 Genotype: T/T|
1755604|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.629||||0.3524|2-Sided|95.0|0.235|1.686||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: A/A|
1755605|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.986||||0.9674|2-Sided|95.0|0.485|2.003||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/A|
1755863|NCT00262873|3225670|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1755606|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.549||||0.2352|2-Sided|95.0|0.201|1.501||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs4705415 Genotype: G/G|
1755607|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.353||||0.1764|2-Sided|95.0|0.072|1.725||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs7407451 Genotype: T/T|
1755608|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.973||||0.9423|2-Sided|95.0|0.462|2.05||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs740751 Genotype: C/T|
1755609|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.724||||0.4179|2-Sided|95.0|0.33|1.593||2-sided unstratified log-rank test|Log Rank|||Locus: rs740751 Genotype: C/C|
1755610|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.845||||0.7463|2-Sided|95.0|0.303|2.355||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/G|
1755611|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.752||||0.3235|2-Sided|95.0|0.423|1.336||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs11740355 Genotype: T/T|
1755612|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.8||||0.3681|2-Sided|95.0|0.488|1.309||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs34586048 Genotype: C/C|
1755613|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|1.327||||0.5897|2-Sided|95.0|0.469|3.755||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/C|
1755614|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.665||||0.1593|2-Sided|95.0|0.373|1.184||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs246396 Genotype: T/T|
1755615|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|1.85||||0.4592|2-Sided|95.0|0.354|9.673||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/A|
1755616|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.715||||0.2018|2-Sided|95.0|0.422|1.209||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs3733678 Genotype: G/G|
1755617|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.353||||0.1764|2-Sided|95.0|0.072|1.725||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: A/A|
1755618|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.992||||0.9834|2-Sided|95.0|0.476|2.069||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/A|
1755619|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.742||||0.4635|2-Sided|95.0|0.331|1.662||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1864972 Genotype: G/G|
1755620|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.573||||0.3587|2-Sided|95.0|0.171|1.92||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: C/C|
1755621|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.986||||0.968|2-Sided|95.0|0.484|2.006||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/C|
1755622|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.531||||0.1626|2-Sided|95.0|0.214|1.317||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304058 Genotype: G/G|
1755623|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.467||||0.2043|2-Sided|95.0|0.14|1.557||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: G/G|
1755624|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.797||||0.5766|2-Sided|95.0|0.355|1.788||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/G|
1755625|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.932||||0.8564|2-Sided|95.0|0.431|2.014||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs919751 Genotype: A/A|
1755626|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|1.859||||0.5341|2-Sided|95.0|0.256|13.51||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: T/T|
1755627|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.577||||0.1379|2-Sided|95.0|0.273|1.221||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/T|
1755628|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.917||||0.8114|2-Sided|95.0|0.447|1.881||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs1077724 Genotype: A/A|
1755629|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|1.026||||0.9491|2-Sided|95.0|0.466|2.26||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/RS2304061 Genotype: G/A|
1755630|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.66||||0.2149|2-Sided|95.0|0.339|1.284||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304061 Genotype: G/G|
1755631|NCT00265317|3225395|Superiority or Other|||||||0.0772||||||2-sided unstratified log-rank test|Log Rank|||Locus PDGFRB/rs17656204 Genotype: T/T|
1755632|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.57||||0.1507|2-Sided|95.0|0.261|1.247||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/T|
1755633|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.738||||0.3804|2-Sided|95.0|0.371|1.467||2-sided, unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs17656204 Genotype: C/C|
1755634|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.686||||0.368|2-Sided|95.0|0.298|1.578||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: A/A|
1755635|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|0.788||||0.5013|2-Sided|95.0|0.39|1.592||2-sided unstratified log-rank test|Log Rank|||PDGFRB/rs2304060 C/A|
1755636|NCT00265317|3225395|Superiority or Other||Hazard Ratio (HR)|1.289||||0.7301|2-Sided|95.0|0.304|5.47||2-sided unstratified log-rank test|Log Rank|||Locus: PDGFRB/rs2304060 Genotype: C/C|
1755637|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|1.458||||0.4682|2-Sided|95.0|0.523|4.06||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: A/A|
1755638|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|0.779||||0.4415|2-Sided|95.0|0.412|1.475||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/A|
1755639|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|1.24||||0.665|2-Sided|95.0|0.466|3.304||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/G|
1755640|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|0.857||||0.8942|2-Sided|95.0|0.089|8.294||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: A/A|
1755641|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|0.692||||0.3103|2-Sided|95.0|0.339|1.416||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/A|
1755642|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|1.326||||0.3944|2-Sided|95.0|0.691|2.544||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/G|
1755643|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|1.419||||0.5089|2-Sided|95.0|0.498|4.04||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: T/T|
1755644|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|0.755||||0.3822|2-Sided|95.0|0.401|1.422||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/T|
1755645|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|1.157||||0.7667|2-Sided|95.0|0.442|3.026||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/C|
1755646|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|1.039||||0.8708|2-Sided|95.0|0.654|1.652||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs3563987 Genotype: C/C|
1755647|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|1.075||||0.8694|2-Sided|95.0|0.453|2.554||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: T/T|
1755648|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|1.057||||0.8696|2-Sided|95.0|0.546|2.044||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/T|
1755649|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|1.047||||0.9317|2-Sided|95.0|0.363|3.025||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/C|
1755650|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|0.954||||0.9224|2-Sided|95.0|0.366|2.484||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/T|
1755651|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|1.073||||0.7966|2-Sided|95.0|0.628|1.833||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/C|
1755652|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|2.236||||0.5596|2-Sided|95.0|0.139|35.9||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: A/A|
1755653|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|0.587||||0.1307|2-Sided|95.0|0.29|1.189||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/A|
1755654|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|1.254||||0.4882|2-Sided|95.0|0.66|2.384||2-sided unstratified log-rank test|Log Rank|||Locus: VEFR/rs1870377 Genotype: T/T|
1755655|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|0.55||||0.624|2-Sided|95.0|0.049|6.208||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: T/T|
1755656|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|1.243||||0.5267|2-Sided|95.0|0.633|2.442||2-sided unstratified log-rank test|Log Rank|||Locus: VEFR2/rs2305945 Genotype: G/T|
1755657|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|1.098||||0.7863|2-Sided|95.0|0.554|2.175||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305845 Genotype: G/G|
1755658|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|2.876||||0.2009|2-Sided|95.0|0.534|15.48||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: T/T|
1755659|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|0.961||||0.9084|2-Sided|95.0|0.487|1.897||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/T|
1755660|NCT00265317|3225397|Superiority or Other||Hazard Ratio (HR)|0.977||||0.9486|2-Sided|95.0|0.473|2.014||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/C|
1755661|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.953||||0.9198|2-Sided|95.0|0.365|2.489||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: A/A|
1755662|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.538||||0.0854|2-Sided|95.0|0.261|1.108||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/A|
1755663|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|1.4||||0.521|2-Sided|95.0|0.492|3.987||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2071559 Genotype: G/G|
1755664|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|1.724||||0.5493|2-Sided|95.0|0.284|10.47||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: A/A|
1755665|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.501||||0.0845|2-Sided|95.0|0.223|1.126||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/A|
1755666|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|1.034||||0.9235|2-Sided|95.0|0.522|2.048||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs41408948 Genotype: G/G|
1755667|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|1.564||||0.4772|2-Sided|95.0|0.444|5.506||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: T/T|
1755668|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.551||||0.0833|2-Sided|95.0|0.276|1.098||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/T|
1755669|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.86||||0.752|2-Sided|95.0|0.331|2.237||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7667298 Genotype: C/C|
1755670|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.8||||0.3681|2-Sided|95.0|0.488|1.309||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs35636987 Genotype: C/C|
1755671|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.382||||0.668|2-Sided|95.0|0.13|1.12||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: T/T|
1755672|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.939||||0.8563|2-Sided|95.0|0.466|1.889||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/T|
1755673|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.775||||0.6559|2-Sided|95.0|0.251|2.388||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs7692791 Genotype: C/C|
1755674|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|1.075||||0.8971|2-Sided|95.0|0.352|3.286||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/T|
1755675|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.738||||0.2788|2-Sided|95.0|0.422|1.288||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305948 Genotype: C/C|
1755676|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|2.236||||0.5596|2-Sided|95.0|0.139|35.9||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: A/A|
1757358|NCT00234078|3228033|Superiority or Other|||||||0.029||||||p-value is adjusted for multiple comparisons|t-test, 2 sided||||
1755677|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.378||||0.0141|2-Sided|95.0|0.168|0.85||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/A|
1755678|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|1.011||||0.9753|2-Sided|95.0|0.504|2.027||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1870377 Genotype: T/T|
1755679|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.794||||0.5268|2-Sided|95.0|0.385|1.64||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: G/T|
1755680|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.833||||0.621|2-Sided|95.0|0.401|1.732||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs2305945 Genotype: G/G|
1755681|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.794||||0.7954|2-Sided|95.0|0.131|4.819||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: T/T|
1755682|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|0.598||||0.157|2-Sided|95.0|0.29|1.236||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/T|
1755683|NCT00265317|3225398|Superiority or Other||Hazard Ratio (HR)|1.13||||0.7423|2-Sided|95.0|0.541|2.36||2-sided unstratified log-rank test|Log Rank|||Locus: VEGFR2/rs1531289 Genotype: C/C|
1755684|NCT00265317|3225400|Superiority or Other||Hazard Ratio (HR)|0.825||||0.2664|2-Sided|95.0|0.457|1.489|||Log Rank|||Indeterminate KRAS Gene Mutation|
1755685|NCT00265317|3225400|Superiority or Other||Hazard Ratio (HR)|1.162||||0.6439|2-Sided|95.0|0.534|2.531|||Log Rank|||Wild Type KRAS Gene Mutation|
1755686|NCT00265317|3225400|Superiority or Other||Hazard Ratio (HR)|0.481||||0.2077|2-Sided|95.0|0.079|2.91|||Log Rank|||Mutated KRAS Gene Mutation|
1755687|NCT00265317|3225402|Superiority or Other||Hazard Ratio (HR)|0.813||||0.2413|2-Sided|95.0|0.464|1.424|||Log Rank|||Indeterminate EGFR Gene Mutation|
1755688|NCT00265317|3225402|Superiority or Other||Hazard Ratio (HR)|1.16||||0.6324|2-Sided|95.0|0.516|2.608|||Log Rank|||Wild Type EGFR Gene Mutation|
1755689|NCT00265317|3225404|Superiority or Other||Hazard Ratio (HR)|0.715||||0.1529|2-Sided|95.0|0.38|1.344|||Log Rank|||Unmeasured EGFR Gene Amplification|
1755690|NCT00265317|3225404|Superiority or Other||Hazard Ratio (HR)|1.078||||0.5839|2-Sided|95.0|0.557|2.085|||Log Rank|||No EGFR Gene Amplification|
1755691|NCT00265317|3225406|Superiority or Other||Hazard Ratio (HR)|0.715||||0.1529|2-Sided|95.0|0.38|1.344|||Log Rank|||Unmeasured EGFR Gene Copy Number Increase|
1755692|NCT00265317|3225406|Superiority or Other||Hazard Ratio (HR)|1.049||||0.5526|2-Sided|95.0|0.542|2.031|||Log Rank|||No EGFR Gene Copy Number Increase|
1755693|NCT00265317|3225408|Superiority or Other||Hazard Ratio (HR)|0.632||||0.1693|2-Sided|95.0|0.245|1.627|||Log Rank|||Unmeasured EGFR Expression|
1755694|NCT00265317|3225408|Superiority or Other||Hazard Ratio (HR)|0.946||||0.4608|2-Sided|95.0|0.362|2.474|||Log Rank|||Negative EGFR Expression|
1755695|NCT00265317|3225408|Superiority or Other||Hazard Ratio (HR)|0.864||||0.3223|2-Sided|95.0|0.458|1.628|||Log Rank|||Positive EGFR Expression|
1755696|NCT00265317|3225410|Superiority or Other||Hazard Ratio (HR)|0.632||||0.1693|2-Sided|95.0|0.245|1.627|||Log Rank|||Unmeasured EGFR Expression|
1755697|NCT00265317|3225410|Superiority or Other||Hazard Ratio (HR)|1.184||||0.6797|2-Sided|95.0|0.581|2.414|||Log Rank|||Negative EGFR Expression|
1755698|NCT00265317|3225410|Superiority or Other||Hazard Ratio, log|0.748||||0.2247|2-Sided|95.0|0.351|1.591|||Log Rank|||Positive EGFR Expression|
1755699|NCT00265317|3225438|Superiority or Other||Percentage|42.0|||||2-Sided|95.0|30.1|54.2||||||Percentage of participants surviving at 1 year in the Erlotinib + Placebo Treatment Group, estimated using the Kaplan-Meier method|
1755700|NCT00265317|3225438|Superiority or Other||Percentage|32.0|||||2-Sided|95.0|19.7|44.3||||||Percentage of participants surviving at 1 year in the Sunitinib + Erlotinib Treatment Group, estimated using the Kaplan-Meier method|
1755701|NCT00265317|3225439|Superiority or Other||Hazard Ratio (HR)|1.066||||0.6171|2-Sided|95.0|0.705|1.612||p-value from 1-sided unstratified log-rank test|Log Rank||||
1755702|NCT00265317|3225441|Superiority or Other||Hazard Ratio (HR)|0.921||||0.3732|2-Sided|95.0|0.572|1.485||1-sided unstratified log-rank test|Log Rank||||
1755703|NCT00265317|3225442|Superiority or Other||Risk Ratio (RR)|1.546||||0.6251|2-Sided|95.0|0.267|8.954|||Cochran-Mantel-Haenszel|||95% confidence interval (CI) calculated based on f-distribution|
1755704|NCT00265317|3225443|Superiority or Other||Hazard Ratio (HR)|0.898||||0.3206|2-Sided|80.0|0.575|1.404||Primary analysis was based on an unstratified 1-sided log rank test with alpha=0.1|Log Rank|||Sample size for randomized portion of study determined based on these assumptions: median PFS (erlotinib)=10 weeks, accrual time=12 months. With 6 months follow-up, study was powered to detect a difference in PFS of 5 weeks. 1-sided log rank test comparing the 2 treatment groups with 115 events of PD or death among a target sample size of 126 participants (63 per group) achieved 80% power at a 10% significance level to detect a 50% improvement in PFS from 10 to 15 weeks.|
1755705|NCT00265122|3225449|Superiority or Other|||||||0.292||||||The P-Value is from a CMH test stratified by the route of administration.|Cochran-Mantel-Haenszel||||
1755706|NCT00265122|3225451|Superiority or Other|||||||0.337||||||The P-Value is from a Cochran-Mantel-Haenszel (CMH) test stratified by the route of administration.|Cochran-Mantel-Haenszel|||Null hypothesis: No difference between ustekinumab and placebo at a significant level of 0.05.|
1755707|NCT00265096|3225465|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)|||
1755708|NCT00265096|3225465|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)|||
1755709|NCT00265096|3225465|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline Methotrexate (MTX) usage)|||
1755710|NCT00265096|3225466|Superiority or Other|||||||0.086||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant|ANOVA|ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage|||
1755711|NCT00265096|3225466|Superiority or Other|||||||0.011||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant|ANOVA|ANOVA on van der Waerden scores with 2 factors: treatment group and participant's baseline Methotrexate (MTX) usage|||
1755712|NCT00265096|3225466|Superiority or Other|||||||0.015||||||The test was not to be performed if the test of ACR 20 at Week 24 was not significant.|ANOVA|Analysis of Variance (ANOVA) on van der Waerden scores with 2 factors: treatment group and participant's baseline methotrexate (MTX) usage||Null Hypothesis: There is no difference in change from baseline among 3 treatment groups. Sample size (n=396, 110 placebo, 286 combined golimumab) provided >93% power to detect a significant difference (alpha=0.05) in change from baseline between treatment groups, assuming 50% of subjects received MTX at baseline, and mean change from baseline for combined golimumab of 0, and a mean increase for placebo of 0.1 in subjects who received MTX at baseline and 0.6 in subjects who did not receive MTX|
1755713|NCT00265096|3225467|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores|With 2 factors (treatment and subject’s baseline MTX usage)|||
1755714|NCT00265096|3225467|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores|With 2 factors (with treatment and subject’s baseline MTX usage)|||
1755715|NCT00265096|3225467|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores|With 2 factors (treatment and subject’s baseline Methotrexate (MTX) usage)|||
1755716|NCT00265096|3225468|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject’s baseline MTX usage)|||
1755717|NCT00265096|3225468|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject’s baseline MTX usage)|||
1755718|NCT00265096|3225468|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores|With 2 factors (treatment group and subject’s baseline Methotrexate (MTX) usage)|||
1755719|NCT00265096|3225469|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)|||
1755720|NCT00265096|3225469|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)|||
1755721|NCT00265096|3225469|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage)|||
1755722|NCT00265096|3225470|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).|||
1755723|NCT00265096|3225470|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).|||
1755724|NCT00265096|3225470|Superiority or Other||||||<|0.001||||||The positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise conparisons at 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) with stratification (stratified by baseline MTX usage).||Null Hypothesis: No difference in ACR 20 response comparing Groups I vs II and Groups I vs III. Sample size (n=396; 110 placebo, 286 combined golimumab) provided >98% power to detect a significant difference (alpha=0.05) in ACR 20 response between treatment groups, assuming equal proportions of subjects receiving methotrexate (MTX) at baseline and the difference in ACR 20 response of 27% in subjects without MTX and 17-27% in subjects with MTX, between placebo and combined golimumab groups.|
1755725|NCT00265083|3225471|Superiority or Other|||||||0.247|||||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASMI between Group III and Group I.|
1755726|NCT00265083|3225471|Superiority or Other|||||||0.444|||||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASMI between Group II and Group I.|
1755727|NCT00265083|3225471|Superiority or Other|||||||0.288||||||The positive test is defined if the comparison between combined golimumab and placebo is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: No difference in change from baseline in BASMI comparing Groups I vs. II and Groups I vs. III.|
1755728|NCT00265083|3225472|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASFI between Group III and Group I.|
1755729|NCT00265083|3225472|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: no difference in BASFI between Group II and Group I.|
1755730|NCT00265083|3225472|Superiority or Other||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value <0.05), and at least one of the pair-wise comparisons is also significant (p-value <0.05).|ANOVA on van der Waerden normal scores|ANOVA on van der Waerden normal scores with 2 factors: treatment group and screening C-reactive protein (CRP) level.||Null hypothesis: No difference in change from baseline in BASFI comparing Groups I vs. II and Groups I vs. III.|
1755731|NCT00265083|3225473|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (<=1.5mg/dL, >1.5mg/dL)||Null hypothesis: no difference in ASAS 20 response between Group III and Group I.|
1755732|NCT00265083|3225473|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (<=1.5mg/dL, >1.5mg/dL)||Null hypothesis: no difference in ASAS 20 response between Group II and Group I.|
1755733|NCT00265083|3225473|Superiority or Other||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value <0.05), and at least one of the pair-wise comparisons is also significant (p-value <0.05).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (<=1.5mg/dL, >1.5mg/dL)||Null hypothesis: No difference in ASAS 20 response comparing Groups I vs. II and Groups I vs. III.|
1755734|NCT00265083|3225474|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (<=1.5mg/dL, >1.5mg/dL)|||
1755735|NCT00265083|3225474|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (<=1.5mg/dL, >1.5mg/dL)|||
1759149|NCT00191152|3230712|Superiority or Other|||||||0.385|||||||Log Rank||||
1755736|NCT00265083|3225474|Superiority or Other||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab and placebo is significant (p-value <0.05), and at least one of the pair-wise comparisons is also significant (p-value <0.05).|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel with stratification: screening CRP level (<=1.5mg/dL, >1.5mg/dL)||Null hypothesis: No difference in ASAS 20 response comparing Groups I vs II and Groups I vs III. The sample size of 75 patients (pts) in placebo and 135 pts per active group will provide >=99% power to detect a difference in ASAS 20 response between treatment groups at alpha=0.05, assuming 50% of pts with screening CRP<1.5mg/dL, and the difference in ASAS 20 response of 10-27.5% in pts with screening CRP<1.5mg/dL and 32.5-45% in pts with screening CRP>=1.5mg/dL, between Groups I vs II or III.|
1755737|NCT00264576|3225499|Non-Inferiority or Equivalence|To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5.|Ratio of GMT|1.33|||||2-Sided|95.0|1.13|1.58||||||"The following hypotheses were tested for B strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) <0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) >0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV_f(i)=GMT for strain i in eTIV_f group."|
1755738|NCT00264576|3225499|Non-Inferiority or Equivalence|To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5.|Ratio of GMT|0.69|||||2-Sided|95.0|0.57|0.83||||||"The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) <0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) >0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV_f(i)=GMT for strain i in eTIV_f group."|
1755739|NCT00264576|3225499|Non-Inferiority or Equivalence|To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5.|Ratio of GMT|0.92|||||2-Sided|95.0|0.76|1.12||||||"The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) <0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) >0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV_f(i)=GMT for strain i in eTIV_f group."|
1755740|NCT00264576|3225499|Non-Inferiority or Equivalence|To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5.|Ratio of GMT|1.16|||||2-Sided|95.0|0.98|1.38||||||"The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) <0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) >0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV_f(i)=GMT for strain i in eTIV_f group."|
1755741|NCT00264576|3225499|Non-Inferiority or Equivalence|To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5.|Ratio of GMT|0.63|||||2-Sided|95.0|0.52|0.76||||||"The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) <0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) >0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV_f(i)=GMT for strain i in eTIV_f group."|
1755742|NCT00264576|3225499|Non-Inferiority or Equivalence|To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5.|Ratio of GMT|0.85|||||2-Sided|95.0|0.7|1.03||||||"The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) <0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) >0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV_f(i)=GMT for strain i in eTIV_f group."|
1755743|NCT00264576|3225505|Non-Inferiority or Equivalence|To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be >0.5.|Ratio of GMT|1.31|||||2-Sided|95.0|1.09|1.57||||||"The following hypotheses were tested for B strain as measured by cell-culture-derived assay:~H0i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) <0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) >0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV_f(i)=GMT for strain i in eTIV_f group."|
1755744|NCT00264576|3225505|Non-Inferiority or Equivalence|To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be >0.5.|Ratio of GMT|0.61|||||2-Sided|95.0|0.5|0.75||||||"The following hypotheses were tested for A/H3N2 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) <0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) >0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV_f(i)=GMT for strain i in eTIV_f group."|
1755745|NCT00264576|3225505|Non-Inferiority or Equivalence|To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination geometric mean titers (GMTs) had to be >0.5.|Ratio of GMT|0.92|||||2-Sided|95.0|0.76|1.12||||||"The following hypotheses were tested for A/H1N1 strain as measured by HI cell-culture-derived assay:~H0i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) <0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) >0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV_f(i)=GMT for strain i in eTIV_f group."|
1755777|NCT00264537|3225513|Superiority or Other|||||||0.025|||||||ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (< 1.5 mg/dL; >= 1.5 mg/dL)||Null hypothesis: No difference in vdH-S score comparing Groups 1 vs 4.|
1755778|NCT00264537|3225513|Superiority or Other|||||||0.015|||||||ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (< 1.5 mg/dL; >= 1.5 mg/dL)||Null hypothesis: No difference in vdH-S score comparing Groups 1 vs 3.|
1755746|NCT00264576|3225505|Non-Inferiority or Equivalence|To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5.|Ratio of GMT|1.14|||||2-Sided|95.0|0.95|1.36||||||"The following hypotheses were tested for B strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) <0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) >0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV_f(i)=GMT for strain i in eTIV_f group."|
1755747|NCT00264576|3225505|Non-Inferiority or Equivalence|To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5.|Ratio of GMT|0.57|||||2-Sided|95.0|0.46|0.7||||||"The following hypotheses were tested for A/H3N2 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) <0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) >0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV_f(i)=GMT for strain i in eTIV_f group."|
1755748|NCT00264576|3225505|Non-Inferiority or Equivalence|To demonstrate non-inferiority of cTIV to eTIV_f the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5.|Ratio of GMT|0.85|||||2-Sided|95.0|0.7|1.04||||||"The following hypotheses were tested for A/H1N1 strain as measured by HI egg-derived assay:~H0i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) ≥0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) ≤0.5 (null hypothesis); H1i: log(GMTeTIV_f(i)) – log(GMTcTIV(i)) <0.301 ↔ GMTcTIV(i) / GMTeTIV_f(i) >0.5 (alternative hypothesis); With: GMTcTIV(i)=GMT for strain i in cTIV group; GMTeTIV_f(i)=GMT for strain i in eTIV_f group."|
1755749|NCT00264550|3225506|Superiority or Other|||||||0.361|||||||ANOVA on van der Waerden normal scores||||
1755750|NCT00264550|3225506|Superiority or Other|||||||0.293|||||||ANOVA on van der waerden normal scores||||
1755751|NCT00264550|3225506|Superiority or Other|||||||0.953|||||||ANOVA on van der Waerden normal scores||||
1755752|NCT00264550|3225506|Superiority or Other|||||||0.551|||||||ANOVA on van der Waerden normal||||
1755753|NCT00264550|3225507|Superiority or Other|||||||0.097|||||||ANOVA on van der Waerden normal scores||||
1755754|NCT00264550|3225507|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores||||
1755755|NCT00264550|3225507|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores||||
1755756|NCT00264550|3225507|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden noramal||||
1755757|NCT00264550|3225508|Superiority or Other|||||||0.187|||||||Chi-squared||||
1755758|NCT00264550|3225508|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1755759|NCT00264550|3225508|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1755760|NCT00264550|3225508|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1755761|NCT00264550|3225509|Superiority or Other|||||||0.24|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and II at 0.05 level of significance.|
1755762|NCT00264550|3225509|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and IV at 0.05 level of significance.|
1755763|NCT00264550|3225509|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and III at 0.05 level of significance.|
1755764|NCT00264550|3225509|Superiority or Other||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab+MTX and Group I is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|ANOVA on van der Waerden normal scores.|||Null hypothesis: No difference in HAQ response at Wk 24 comparing Groups I and Combined Golimumab + Methotrexate (MTX) at 0.05 level of significance.|
1755765|NCT00264550|3225510|Superiority or Other|||||||0.035|||||||Chi-squared||||
1755766|NCT00264550|3225510|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1755767|NCT00264550|3225510|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1755768|NCT00264550|3225510|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1755769|NCT00264550|3225511|Superiority or Other|||||||0.059||||||This null hypothesis is tested only if a positive test for null hypothesis Statistical Analysis 1.|Chi-squared|||Null hypothesis: No difference between Group II and Group I with respect of ACR 20 at Wk 14. Superiority of golimumab alone vs MTX alone will be demonstrated if 2-sided test is significant. Sample of 120 patients in each Group I & II provides >85% power assuming 35% ACR 20 response in Group I and 55% ACR 20 in Group II.|
1755770|NCT00264550|3225511|Superiority or Other||||||<|0.001|||||||Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide >90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III & IV).|
1755771|NCT00264550|3225511|Superiority or Other||||||<|0.001|||||||Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Samples of sizes 120, 80, 80 patients in Group I, III, and IV provide >90% power assuming 35% response in Group I and 55% ACR 20 response in golimumab groups(III & IV).|
1755772|NCT00264550|3225511|Superiority or Other||||||<|0.001||||||The positive test is defined if the comparison between combined golimumab+MTX and Group 1 is significant at the 0.05, and at least one of the pair-wise comparisons is also significant at the 0.05.|Chi-squared|||Null hypothesis: No difference in ACR 20 response at Wk 14 comparing Groups I vs III and Groups I vs IV at 0.05 level of significance. Assuming greater than 90 % power, ACR 20 response for Group I, Group III and Group IV (120, 80, and 80 participants, respectively) as 35 % for Group I and 55 % for Groups III and IV.|
1755773|NCT00264537|3225512|Superiority or Other|||||||0.545|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores|||
1755774|NCT00264537|3225512|Superiority or Other|||||||0.014|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores|||
1755775|NCT00264537|3225512|Superiority or Other|||||||0.01|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores|||
1755776|NCT00264537|3225512|Superiority or Other|||||||0.003|||||||ANOVA|2-sided ANOVA on the van der Waerden normal scores|||
1755779|NCT00264537|3225513|Superiority or Other|||||||0.006||||||If this test is significant, a pairwise comparison between Group 3 and Group 1, and between Group 4 and Group 1 will be performed|ANOVA|A 2-sided ANOVA on the van der Waerden normal scores with 1 factor: screening CRP (< 1.5 mg/dL; ≥ 1.5 mg/dL)||Null Hypothesis: No difference in vdH-S score comparing Groups 1 vs Groups 3 and 4 combined. The sample size of 150 subjects in each treatment group (Group 1, Group 3, Group 4) will provide > 95% power to detect a difference in the vdH-S score between treatment groups using a 2-sided t-test on van der Waerden normal scores of change from baseline in vdH-S score at α = 0.05, assuming a mean change from baseline in vdH-S score of 3.5 for the placebo group and 1 for Groups 3 and 4.|
1755780|NCT00264537|3225514|Superiority or Other|||||||0.339|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (< 1.5 mg/dL; >= 1.5 mg/dL)|||
1755781|NCT00264537|3225514|Superiority or Other|||||||0.24|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (< 1.5 mg/dL; >= 1.5 mg/dL)|||
1755782|NCT00264537|3225514|Superiority or Other|||||||0.25|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (< 1.5 mg/dL; >= 1.5 mg/dL)|||
1755783|NCT00264537|3225514|Superiority or Other|||||||0.178|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (< 1.5 mg/dL; >= 1.5 mg/dL)|||
1755784|NCT00264537|3225515|Superiority or Other|||||||0.677|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (< 1.5 mg/dL; >= 1.5 mg/dL)|||
1755785|NCT00264537|3225515|Superiority or Other|||||||0.028|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (< 1.5 mg/dL; >= 1.5 mg/dL)|||
1755786|NCT00264537|3225515|Superiority or Other|||||||0.028|||||||Cochran-Mantel-Haenszel|CMH test stratified by screening CRP (< 1.5 mg/dL; >= 1.5 mg/dL)|||
1755787|NCT00264537|3225515|Superiority or Other|||||||0.011|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel(CMH) test stratified by screening C-reactive protein (CRP) (< 1.5 mg/dL; >= 1.5 mg/dL)|||
1755788|NCT00264537|3225516|Non-Inferiority or Equivalence|This sample size (150 patients per treatment group) will provide approximately 85% power to claim non-inferiority of golimumab alone (Group 2) compared with MTX alone (Group 1) at alpha= 0.05 using a one-sided equivalence test assuming the proportion of golimumab alone (Group 2) treated patients with ACR 50 response is not less than 10% compared with proportion of patients with ACR 50 response in MTX alone (Group 1) treated group.|Difference in ACR 50 Response Rate(%)|3.3||||0.521||95.0|-6.8||The upper bound of 95% CI was not produced because it was not relevant to the pre-specified analysis||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (< 1.5 mg/dL; >= 1.5 mg/dL)|The positive difference indicates in favor of golimumab+placebo compared to placebo+MTX; The upper bound of CI is not applicable.|"Null hypothesis: Group 2 is inferior to Group 1. Noninferiority of golimumab will be demonstrated if the lower bound of the 2-sided 95% CI is above -10%. The 10% non-inferiority margin was chosen because this difference is not clinically admissible. Under the above noted assumed response rates, this corresponds to preservation of at least 70% [(33% - 10%)/33%*100] of the expected MTX benefit."|
1755789|NCT00264537|3225516|Superiority or Other|||||||0.177|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (< 1.5 mg/dL; >= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Groups 1 vs 4.|
1755790|NCT00264537|3225516|Superiority or Other|||||||0.042|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening C-reactive protein (CRP) (< 1.5 mg/dL; >= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Groups 1 vs 3.|
1755791|NCT00264537|3225516|Superiority or Other|||||||0.053||||||A positive test is concluded if there is a significant difference between golimumab+MTX and placebo+MTX and at least one of the pair-wise comparisons at a 0.05 level.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel (CMH) test stratified by screening CRP (< 1.5 mg/dL; >= 1.5 mg/dL)||Null hypothesis: No difference in ACR 50 response comparing Group 1 vs combined Groups 3 and 4. The sample size of 150 patients per treatment group will provide >98% power to detect a difference in ACR 50 response between treatment groups at alpha=0.05, assuming 50% of patients with screening C-reactive protein (CRP)<1.5mg/dL, and the difference in ACR 50 response of 15-20% in patients with screening CRP<1.5mg/dL and 20-25% in subjects with screening CRP>=1.5mg/dL, between Groups 1 vs 3 or 4|
1755792|NCT00264303|3225522|Superiority or Other||Mean Difference (Net)|0.16|||<|0.001||95.0|0.07|0.26|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline severity as covariate.||The primary hypothesis to be tested in this study was that the clinical efficacy of Levocetirizine 5 mg is superior to that of Desloratidine 5 mg|
1755793|NCT00264303|3225523|Superiority or Other||Mean Difference (Net)|0.12||||0.009||95.0|0.03|0.22|||ANCOVA|ANCOVA with treatment and pooled centers as factors and baseline pruritus duration score as covariate.|||
1755794|NCT00264303|3225524|Superiority or Other||Mean Difference (Net)|0.16||||0.002||95.0|0.06|0.26|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline pruritus duration as covariate.|||
1755795|NCT00264303|3225525|Superiority or Other||Mean Difference (Net)|0.13||||0.004||95.0|0.04|0.22|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline pruritus severity score as covariate.|||
1755796|NCT00264303|3225526|Superiority or Other||Mean Difference (Net)|0.17||||0.041||95.0|0.01|0.34|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate|||
1755797|NCT00264303|3225527|Superiority or Other||Mean Difference (Net)|0.25||||0.005||95.0|0.08|0.43|||ANCOVA|ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate.|||
1755798|NCT00264147|3225536|Superiority or Other||Mean Difference (Final Values)|-4.63||||||95.0|-9.81|0.55|||||||
1755799|NCT00264147|3225536|Superiority or Other||Mean Difference (Final Values)|-6.32||||||95.0|-11.53|-1.12|||||||
1755800|NCT00264147|3225536|Superiority or Other||Mean Difference (Final Values)|-6.22||||||95.0|-11.52|-0.92|||||||
1755801|NCT00264147|3225536|Superiority or Other||Mean Difference (Final Values)|-14.44||||||95.0|-19.62|-9.26|||||||
1755802|NCT00264147|3225536|Superiority or Other|||||||0.08||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1759150|NCT00191152|3230713|Superiority or Other|||||||0.145|||||||Log Rank||||
1755803|NCT00264147|3225536|Superiority or Other|||||||0.017||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755804|NCT00264147|3225536|Superiority or Other|||||||0.018||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755805|NCT00264147|3225536|Superiority or Other||||||<|0.001||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755806|NCT00264147|3225537|Superiority or Other||Mean Difference (Final Values)|-0.25||||||95.0|-0.46|-0.04|||||||
1755807|NCT00264147|3225537|Superiority or Other||Mean Difference (Final Values)|-0.4||||||95.0|-0.61|-0.19|||||||
1755808|NCT00264147|3225537|Superiority or Other||Mean Difference (Final Values)|-0.34||||||95.0|-0.55|-0.13|||||||
1755809|NCT00264147|3225537|Superiority or Other||Mean Difference (Final Values)|-0.56||||||95.0|-0.77|-0.35|||||||
1755810|NCT00264147|3225537|Superiority or Other|||||||0.018||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755811|NCT00264147|3225537|Superiority or Other||||||<|0.001||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755812|NCT00264147|3225537|Superiority or Other||||||<|0.001||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755813|NCT00264147|3225537|Superiority or Other||||||<|0.001||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755814|NCT00264147|3225538|Superiority or Other||Mean Difference (Final Values)|-6.05||||||95.0|-11.27|-0.83|||||||
1755815|NCT00264147|3225538|Superiority or Other||Mean Difference (Final Values)|-8.87||||||95.0|-14.11|-3.63|||||||
1755816|NCT00264147|3225538|Superiority or Other||Mean Difference (Final Values)|-9.21||||||95.0|-14.52|-3.9|||||||
1755817|NCT00264147|3225538|Superiority or Other||Mean Difference (Final Values)|-14.16||||||95.0|-19.38|-8.95|||||||
1755818|NCT00264147|3225538|Superiority or Other|||||||0.023||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755819|NCT00264147|3225538|Superiority or Other||||||<|0.001||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755820|NCT00264147|3225538|Superiority or Other||||||<|0.001||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755821|NCT00264147|3225538|Superiority or Other||||||<|0.001||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755822|NCT00264147|3225539|Superiority or Other||Mean Difference (Final Values)|-0.49||||||95.0|-1.89|0.91|||||||
1755823|NCT00264147|3225539|Superiority or Other||Mean Difference (Final Values)|-1.22||||||95.0|-2.63|0.18|||||||
1755824|NCT00264147|3225539|Superiority or Other||Mean Difference (Final Values)|-1.02||||||95.0|-2.44|0.41|||||||
1755825|NCT00264147|3225539|Superiority or Other||Mean Difference (Final Values)|-2.24||||||95.0|-3.64|-0.84|||||||
1755826|NCT00264147|3225539|Superiority or Other|||||||0.125||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755827|NCT00264147|3225539|Superiority or Other|||||||0.001||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755828|NCT00264147|3225540|Superiority or Other||Mean Difference (Final Values)|-2.5||||||95.0|-4.88|-0.12|||||||
1755829|NCT00264147|3225540|Superiority or Other||Mean Difference (Final Values)|-2.74||||||95.0|-5.13|-0.35|||||||
1755830|NCT00264147|3225540|Superiority or Other||Mean Difference (Final Values)|-1.49||||||95.0|-3.91|0.93|||||||
1755831|NCT00264147|3225540|Superiority or Other||Mean Difference (Final Values)|-4.06||||||95.0|-6.44|-1.68|||||||
1755832|NCT00264147|3225540|Superiority or Other|||||||0.221||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755833|NCT00264147|3225540|Superiority or Other|||||||0.002||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|ANCOVA|Based on a trend test with a step-down procedure and Abelson-Tukey scaling.|||
1755834|NCT00264147|3225541|Superiority or Other||difference in percentage of patients|6.49||||||95.0|-3.76|16.61|||||CI based on the Wilson's score method.||
1755835|NCT00264147|3225541|Superiority or Other||difference in percentage of patients|9.18||||||95.0|-1.25|19.39|||||CI based on the Wilson's score method.||
1755836|NCT00264147|3225541|Superiority or Other||difference in percentage of patients|10.0||||||95.0|-0.66|20.46|||||CI based on the Wilson's score method.||
1757359|NCT00234078|3228033|Superiority or Other|||||||0.004||||||p-value is adjusted for multiple comparisons|t-test, 2 sided||||
1755838|NCT00264147|3225541|Superiority or Other|||||||0.057||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|Cochran-Armitage trend test|A step-down procedure and Abelson-Tukey scaling were used for the trend test.|||
1755839|NCT00264147|3225541|Superiority or Other||||||<|0.001||||||Overall alpha=0.05 for multiple comparisons with a step-down procedure (p-values subsequent to the first non-significant p-value were not reported).|Cochran-Armitage trend test|A step-down procedure and Abelson-Tukey scaling were used for the trend test.|||
1755840|NCT00263887|3225553|Superiority or Other|||||||0.049|||||||ANCOVA|||The main effect ANCOVA model includes the change from baseline to endpoint as the dependent variable, treatment and center as fixed factors, change in logarithm of total lung volume and baseline measurement as covariates.|
1755841|NCT00262964|3225649|Superiority or Other|||||||0.018||||||The a priori threshold for significance was set at p<0.05.|t-test, 2 sided|||The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.|
1755842|NCT00262964|3225649|Superiority or Other|||||||0.419||||||The a priori threshold for significance was set at p<0.05.|t-test, 2 sided|||The null hypothesis was that fenofibrate would not affect hepatic insulin sensitivity. Here we compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.|
1755843|NCT00262964|3225650|Superiority or Other|||||||0.025||||||The a priori threshold for significance was set at p<0.05.|t-test, 2 sided|||The null hypothesis was that niacin would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results for subjects receiving a 16 week course of niacin.|
1755844|NCT00262964|3225650|Superiority or Other|||||||0.318||||||The a priori threshold for significance was set at p<0.05.|t-test, 2 sided|||The null hypothesis was that fenofibrate would not affect skeletal muscle insulin sensitivity. Here we compare the pre and post-treatment results in subjects receiving an 8 week course of fenofibrate.|
1755845|NCT00262964|3225651|Superiority or Other|||||||0.019||||||A priori threshold for significance was set for p<0.05.|t-test, 2 sided|||Null hypothesis was that niacin would not affect adipose tissue insulin sensitivity. Here we compare the baseline and post-treatment adipose tissue insulin sensitivity results for subjects who received a 16 week course of niacin|
1755846|NCT00262964|3225651|Superiority or Other|||||||0.768||||||A priori threshold for significance was set for p<0.05.|t-test, 2 sided|||Null hypothesis was that fenofibrate would not affect adipose tissue insulin sensitivity. We compare the baseline and post-treatment results for adipose tissue insulin sensitivity in the subjects who received fenofibrate.|
1755847|NCT00262964|3225652|Superiority or Other||||||<|0.001||||||the a priori threshold for statistical significance was p<0.05|t-test, 2 sided|||The null hypothesis was that niacin would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving a 16 week course of niacin.|
1755848|NCT00262964|3225652|Superiority or Other||||||<|0.024||||||the a priori threshold for statistical significance was p <0.05|t-test, 2 sided|||Null hypothesis was that fenofibrate would not affect VLDL-Tg concentration. We compare the pre and post-treatment results of subjects receiving an 8 week course of fenofibrate.|
1755849|NCT00262964|3225653|Superiority or Other|||||||0.023||||||the a priori threshold for statistical significance was set at <0.05.|t-test, 2 sided|||Null hypothesis is that niacin would not effect VLDL-Tg production rates.|
1755850|NCT00262964|3225653|Superiority or Other|||||||0.758||||||a priori threshold for statistical significance was set at <0.05.|t-test, 2 sided|||Null hypothesis is that fenofibrate would not effect VLDL-Tg production rates.|
1755851|NCT00262964|3225654|Superiority or Other|||||||0.358||||||a priori threshold for significance was <0.05.|t-test, 2 sided|||the null hypothesis was that niacin would not change the VLDL-Tg clearance rate|
1755852|NCT00262964|3225654|Superiority or Other|||||||0.02|||||||t-test, 2 sided|||the null hypothesis was that fenofibrate would not change the VLDL-Tg clearance rate|
1755853|NCT00262964|3225655|Superiority or Other|||||||0.022||||||A P-value < 0.05 was considered statistically significant.|t-test, 2 sided|||A Student’s t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 8 weeks on fenofibrate in subjects with NAFLD.|
1755854|NCT00262964|3225655|Superiority or Other|||||||0.708||||||A P-value < 0.05 was considered statistically significant.|t-test, 2 sided|||a Student’s t-test for paired samples was used to evaluate the effect of treatment. Null hypothesis was that VLDL-apoB would be the same before and after 16 weeks on niacin in subjects with NAFLD.|
1755855|NCT00262964|3225656|Superiority or Other|||||||0.315||||||A P-value < 0.05 was considered statistically significant.|t-test, 2 sided|Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student’s t-test was used.||A Student’s t-test for paired samples was used to evaluate the effect of treatment. The null hypothesis was that the IHTG percentage for the NAFLD-niacin group at baseline and post-treatment would not change.|
1755856|NCT00262964|3225656|Superiority or Other|||||||0.301||||||A P-value < 0.05 was considered statistically significant.|t-test, 2 sided|Treatment effects determined by repeated-measures ANOVA. When significant interactions between time and group were found, a Student’s t-test was used.||Student’s t-test for paired samples was used to evaluate any difference between the two groups. The null hypothesis was that the IHTG percentage would be the same before and after treatment for subjects receiving fenofibrate.|
1755857|NCT00262964|3225657|Superiority or Other||||||<|0.002|||||||t-test, 2 sided|||null hypothesis was that there would be no difference in adipose tissue insulin sensitivity due to IHTG levels.|
1755858|NCT00262964|3225658|Superiority or Other||||||<|0.001||||||a priori threshold for significance was set at p = 0.05.|t-test, 2 sided|||null hypothesis was no difference in skeletal muscle insulin sensitivity between groups.|
1755859|NCT00262964|3225659|Superiority or Other||||||<|0.001||||||a priori threshold for significance was P<0.05.|t-test, 2 sided|||null hypothesis was that VLDL-TG production would not differ between the two groups.|
1755860|NCT00262964|3225660|Superiority or Other||||||<|0.019|||||||t-test, 2 sided|||null hypothesis was no difference in hepatic insulin sensitivity between normal and high IHTG subjects|
1755861|NCT00262873|3225668|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1755862|NCT00262873|3225669|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1755864|NCT00262847|3225678|Superiority or Other||Hazard Ratio (HR)|0.88||||0.131||95.0|0.746|1.039|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.|||
1755865|NCT00262847|3225678|Superiority or Other||Hazard Ratio (HR)|1.069||||0.41||95.0|0.912|1.255|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.|||
1755866|NCT00262847|3225679|Superiority or Other||Hazard Ratio (HR)|0.765|||<|0.001||95.0|0.676|0.866|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.|||
1755867|NCT00262847|3225679|Superiority or Other||Hazard Ratio (HR)|0.954|||<|0.448||95.0|0.844|1.078|||Regression, Cox|Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.|||
1755868|NCT00262834|3225681|Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)||||
1755869|NCT00262834|3225682|Superiority or Other (legacy)|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum tests were used to compare the differences (post-pre) between groups.|||
1755870|NCT00262834|3225683|Superiority or Other (legacy)|||||||0.42|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank-sum tests were used to compare the differences (post-pre) between groups.|||
1755871|NCT00262730|3225692|Non-Inferiority or Equivalence|study design has 85% power to detect 25% deduction in hazard rate compared to EORTC Phase 3 results.|Hazard Ratio (HR)|0.8|Standard Deviation|0.025|>|0.1|2-Sided|95.0|0.8|0.85|||Log Rank||||
1755872|NCT00262639|3225693|Superiority|||||||0.0006||||||This p value is for the interaction of AW status by medication group.|ANOVA|||The analysis was an ANOVA interaction analysis with alcohol withdrawal (AW) group (Low vs. High) by medication group (active versus placebo medication) across the 6 weeks of the medication trial.|
1755873|NCT00262639|3225694|Superiority|||||||0.03|||||||Regression, Logistic||||
1755874|NCT00262600|3225696|Superiority or Other||Cox Proportional Hazard|0.41|||<|0.0001||95.0|0.28|0.6||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis of ICH|
1755875|NCT00262600|3225696|Superiority or Other||Cox Proportional Hazard|0.3|||<|0.0001||95.0|0.19|0.45||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis of ICH|
1755876|NCT00262600|3225697|Superiority or Other||Cox Proportional Hazard|0.93||||0.3146||95.0|0.81|1.07||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis is for adjudicated major bleeds|
1755877|NCT00262600|3225697|Superiority or Other||Cox Proportional Hazard|0.8||||0.0026||95.0|0.7|0.93||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using Cox regression analysis with treatment in the model.||Analysis is for adjudicated major bleeds|
1755878|NCT00262600|3225698|Superiority or Other||Cox Proportional Hazard|0.84||||0.0093||95.0|0.74|0.96||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|||
1755879|NCT00262600|3225698|Superiority or Other||Cox Proportional Hazard|0.98||||0.7508||95.0|0.87|1.11||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|||
1755880|NCT00262600|3225699|Superiority or Other||Cox Proportional Hazard|0.83||||0.0015||95.0|0.74|0.93||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|||
1755881|NCT00262600|3225699|Superiority or Other||Cox Proportional Hazard|0.93||||0.2206||95.0|0.83|1.04||p-value is for superiority testing|Regression, Cox|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|||
1755882|NCT00262600|3225700|Non-Inferiority or Equivalence|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|Cox Proportional Hazard|0.65|||<|0.0001||95.0|0.52|0.81||p-value for protocol specified margin of 1.46|Regression, Cox|||Non-inferiority comparison of dabigatran 150 mg to warfarin|
1755883|NCT00262600|3225700|Non-Inferiority or Equivalence|Comparisons between treatment groups were performed using a Cox regression analysis with treatment in the model.|Cox Proportional Hazard|0.9|||<|0.0001||95.0|0.74|1.1||p-value for protocol specified margin of 1.46|Regression, Cox|||Non-inferiority comparison of dabigatran 110 mg to warfarin|
1755884|NCT00262522|3225701|Superiority or Other|||||||0.269|||||||ANOVA||||
1755885|NCT00262522|3225702|Non-Inferiority or Equivalence|The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|percentage of subjects responding|-4.3||||0.249||95.0|-11.5|2.8|||normal approx. to the binomial distr.|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.|
1755886|NCT00262522|3225703|Non-Inferiority or Equivalence|The 95% confidence interval for the difference in response rates (QD minus BID, based on the normal approximation to the binomial distribution) was used to assess noninferiority. The QD regimen was considered noninferior to the BID regimen if the lower limit of the confidence interval remained above -12%.|percentage of subjects responding|1.3||||0.715||95.0|-5.1|7.8|||normal approx. to the binomial distr.|||The null hypothesis was that the response rate for the once daily (QD) regimen was more than 12% lower than the response rate for the twice daily (BID) regimen. The planned sample size of 600 subjects (300 subjects in each of the QD and BID treatment regimens) provided over 90% power to reject the null hypothesis, i.e., to determine noninferiority based on the 12% margin.|
1755948|NCT00261495|3225899|Superiority or Other||Mean Difference (Net)|-2.61||||0.118||95.0|-5.88|0.67|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755949|NCT00261495|3225900|Superiority or Other|||||||0.807|||||||Cochran-Mantel-Haenszel|||Exploratory comparison|
1755887|NCT00262522|3225704|Superiority or Other||||||>|0.1|||||||Cochran-Mantel-Haenszel|||Cochran-Mantel-Haenszel (CMH) test stratified by dosing regimen was used to assess the null hypothesis of no difference between the tablet and soft gel capsule (SGC). Sample size was 600 subjects (150 each in the 4 groups). Based on a projected 48% reporting treatment-emergent diarrhea in the QD arm and 32% in the BID arm within the SGC group, with a 12% reduction in the corresponding tablet groups, this sample size provided 80% power to determine a difference between the tablet and SGC.|
1755888|NCT00262301|3225719|Superiority or Other|||||||0.005|||||||Log Rank||||
1755889|NCT00262301|3225720|Superiority or Other|||||||0.003|||||||Log Rank||||
1755890|NCT00262223|3225721|Superiority or Other (legacy)||Parameter Estimate|-16.15||||0.04|2-Sided|95.0|-31.18|-1.13||A trend-level time-by-treatment interaction (p = .096) was probed for simple effects, which revealed a significantly greater reduction in CAPS scores at end-of-treatment in the SS+Sertraline group relative to the SS+Placebo group.|Generalized Estimating Equations|||Generalized estimating equations (GEE) were utilized to model PTSD outcomes. This method is an extension of the generalized linear model that handles correlated data arising from repeated measurements, requires no parametric distribution assumption, and provides robust inference with respect to misspecification of the within-subject correlation. A temporal within-subjects autoregressive [AR(1)] correlation matrix was used to model participants across timepoints.|
1755891|NCT00262223|3225722|Superiority or Other (legacy)||Incidence Rate Ratio|1.6||||0.34|2-Sided|95.0|0.61|4.23|||Generalized Estimating Equations|Negative binomial models with log link were applied to the alcohol consumption measure.||Between group analyses were conducted of time-by-treatment interaction that included the four study time points (baseline, end-of-treatment, 6-mos and 12-mos).|
1755892|NCT00262080|3225743|Superiority or Other|||||||0.055||||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Log Rank|||The Log-Rank test was used to compare the time distribution between the two treatment groups.|
1755893|NCT00262080|3225747|Superiority or Other|||||||0.044||||||No adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|Wilcoxon Rank Sum Test.|||The analysis compared the change from baseline in MSCS score at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the non-parametric Wilcoxon Rank Sum test because of an assumed non-normal distribution.|
1755894|NCT00262080|3225748|Superiority or Other|||||||0.037||||||no adjustment was made for multiple comparisons. Treatment effect will be deemed statistically significant if the coefficient for the treatment group within the statistical model is significant at level 0.05.|non-parametric Wilcoxon Rank Sum test|||The primary efficacy analysis compared the TOS at 4 hours post-dosing for patients treated with ecallantide and placebo. Treatment effect was assessed by the non-parametric Wilcoxon Rank Sum test because of an assumed non-normal distribution.|
1755895|NCT00262041|3225759|Non-Inferiority or Equivalence|Non-inferiority of MenACWY Ad- vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001|||||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup Y compared with that of MenACWY PS vaccine.|
1755896|NCT00262041|3225759|Non-Inferiority or Equivalence|Non-inferiority of MenACWY Ad+ vaccine against the serogroup Y was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001|||||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup Y compared with that of MenACWY PS vaccine.|
1755897|NCT00262041|3225759|Non-Inferiority or Equivalence|Non-inferiority of MenACWY Ad- vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.071|||||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup W compared with that of MenACWY PS vaccine.|
1755898|NCT00262041|3225759|Non-Inferiority or Equivalence|Non-inferiority of MenACWY Ad+ vaccine against the serogroup W was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001|||||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup W compared with that of MenACWY PS vaccine.|
1755899|NCT00262041|3225759|Non-Inferiority or Equivalence|Non-inferiority of MenACWY Ad- vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.003|||||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup C compared with that of MenACWY PS vaccine.|
1755900|NCT00262041|3225759|Non-Inferiority or Equivalence|Non-inferiority of MenACWY Ad+ vaccine against the serogroup C was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001|||||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup C compared with that of MenACWY PS vaccine.|
1755901|NCT00262041|3225759|Non-Inferiority or Equivalence|Non-inferiority of MenACWY Ad- vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001|||||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad- vaccine group against serogroup A compared with that of MenACWY PS vaccine.|
1755902|NCT00262041|3225759|Non-Inferiority or Equivalence|Non-inferiority of MenACWY Ad+ vaccine against the serogroup A was assessed to that of the MenACWY PS vaccine if the lower limit of the two-sided 95% CI around the difference in proportions was greater than -10%.|||||<|0.001|||||||Chi-squared|||To demonstrate non-inferiority of percentages of subjects with hSBA titer ≥ 1:4 who received MenACWY Ad+ vaccine group against serogroup A compared with that of MenACWY PS vaccine.|
1755950|NCT00261495|3225901|Superiority or Other|||||||0.575|||||||Cochran-Mantel-Haenszel|||Exploratory comparison|
1755903|NCT00262028|3225771|Superiority or Other||Vaccine group difference|31.0|||||2-Sided|95.0|25.0|38.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > 0% against each serogroup"|
1755904|NCT00262028|3225771|Superiority or Other||Vaccine group difference|23.0|||||2-Sided|95.0|17.0|29.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > 0% against each serogroup"|
1755905|NCT00262028|3225771|Superiority or Other||Vaccine group difference|19.0|||||2-Sided|95.0|12.0|26.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > 0% against each serogroup"|
1755906|NCT00262028|3225771|Superiority or Other||Vaccine group difference|37.0|||||2-Sided|95.0|29.0|44.0||||||"Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A~MenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > 0% against each serogroup"|
1755907|NCT00262028|3225771|Non-Inferiority or Equivalence|MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > -10% against each serogroup|Vaccine group difference|31.0|||||2-Sided|95.0|25.0|38.0||||||No inferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y|
1755908|NCT00262028|3225771|Non-Inferiority or Equivalence|MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > -10% against each serogroup|Vaccine group difference|23.0|||||2-Sided|95.0|17.0|29.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W|
1755909|NCT00262028|3225771|Non-Inferiority or Equivalence|MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > -10% against each serogroup|Vaccine group difference|19.0|||||2-Sided|95.0|12.0|26.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C|
1755910|NCT00262028|3225771|Non-Inferiority or Equivalence|MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower limit (LL) of the 95% confidence intervals (CI) of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was > -10% against each serogroup|Vaccine group difference|37.0|||||2-Sided|95.0|29.0|44.0||||||Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A|
1755911|NCT00261833|3225857|Superiority or Other||Difference in lung density(adjusted P15)|0.89||||0.115|2-Sided|95.0|-0.57|2.34||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (FRC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects as a repeated random effect at a 1-sided significance level of 0.025.|
1755912|NCT00261833|3225857|Superiority or Other||Difference in lung density(adjusted P15)|1.32||||0.028|2-Sided|95.0|-0.03|2.67||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (i.e., the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (TLC) from baseline to Month 24 was a mixed effects ANCOVA model with country, treatment, and baseline lung density as fixed effects at a 1-sided significance level of 0.025.|
1755913|NCT00261833|3225857|Superiority or Other||Difference in lung density(adjusted P15)|1.04||||0.058|2-Sided|95.0|-0.26|2.34||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model ANCOVA was used to estimate the 95% CI for the difference (Zemaira® - placebo) in the change in lung density.|Analysis of the change in lung density (TLC+FRC combined) from baseline to Month 24 was a mixed effects analysis of covariance (ANCOVA) model with country, treatment, and baseline lung density as fixed effects and inspiration state as a repeated random effect at a 1-sided significance level of 0.025.|
1755914|NCT00261833|3225861|Superiority or Other||Difference in lung density(adjusted P15)|0.478||||0.09|2-Sided|95.0|-0.223|1.18||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (FRC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.|
1755951|NCT00261495|3225906|Superiority or Other|||||||0.32|||||||Cochran-Mantel-Haenszel|||Exploratory comparison|
1755952|NCT00261495|3225907|Superiority or Other||Mean Difference (Net)|-0.02||||0.88||95.0|-0.3|0.26||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755953|NCT00261495|3225908|Superiority or Other||Mean Difference (Net)|-4.16||||0.02||95.0|-7.67|-0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755915|NCT00261833|3225861|Superiority or Other||Difference in lung density(adjusted P15)|0.74||||0.017|2-Sided|95.0|0.059|1.42||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira® minus placebo (ie, the lower bound of the 95% CI being greater than zero) will indicate superiority of Zemaira® compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (TLC) was a linear mixed model with country, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.|
1755916|NCT00261833|3225861|Superiority or Other||Difference in lung density(adjusted P15)|0.618||||0.029|2-Sided|95.0|-0.024|1.261||A 1-sided P-value less than 0.025 and a positive estimate of the treatment difference Zemaira minus placebo (ie, the lower bound of the 95% confidence interval [CI] being greater than zero) will indicate superiority of Zemaira compared with Placebo.|95% confidence interval||A mixed model was used to estimate the 95% CI for the difference (Zemaira® - placebo) in annual lung density decline.|Analysis of the annual rate of change in lung density (TLC+FRC combined) was a linear mixed model with country, inspiration state, time since baseline treatment, and treatment-by-time interaction as fixed effects and participant and participant-by-time interaction as random coefficients at a 1-sided significance level of 0.025.|
1755917|NCT00261716|3225862|Superiority or Other|||||||0.39|||||||Mixed Models Analysis|employment status X time effect (F(1,54)=.74|||
1755918|NCT00261716|3225862|Superiority or Other|||||||0.09|||||||Mixed Models Analysis|time effect (1.54)=2.99,|||
1755919|NCT00261716|3225862|Superiority or Other|||||||0.19|||||||Mixed Models Analysis|employment status effect F(1,12)=1.95,||Intent to treat analysis|
1755920|NCT00261716|3225863|Superiority or Other|||||||0.81|||||||Mixed Models Analysis|employment status X time effect F(1,58)=.06|||
1755921|NCT00261716|3225863|Superiority or Other|||||||0.65|||||||Mixed Models Analysis|time effect F (1,58)=.21 ,.|||
1755922|NCT00261716|3225863|Superiority or Other|||||||0.62|||||||Mixed Models Analysis|employment status effect F(1,12)=.26||intent to treat analysis|
1755923|NCT00261716|3225864|Superiority or Other|||||||0.63|||||||Mixed Models Analysis|employment status X time effect F (1,54)=.. 24|||
1755924|NCT00261716|3225864|Superiority or Other|||||||0.16|||||||Mixed Models Analysis|time effect F(1,54)=.2.05|||
1755925|NCT00261716|3225864|Superiority or Other|||||||0.37|||||||Mixed Models Analysis|employment status effect- F(1,12)=..85||Intent to treat analysis|
1755926|NCT00261716|3225865|Superiority or Other||||||>|0.05|||||||Fisher Exact||||
1755927|NCT00261716|3225865|Superiority or Other||||||>|0.05|||||||Fisher Exact|Fishers exact= 1.0; one degree of freedom||intent to treat --all participants who obtained at least one job|
1755928|NCT00261716|3225866|Superiority or Other|||||||0.41|||||||t-test, 2 sided|degrees of freedom=17|||
1755929|NCT00261716|3225867|Superiority or Other|||||||0.75|||||||t-test, 2 sided|degrees of freedom=36||intent to treat analysis|
1755930|NCT00261716|3225868|Superiority or Other|||||||0.33|||||||Chi-squared|1 degree of freedom||Intent to treat analysis|
1755931|NCT00261495|3225882|Superiority or Other||Mean Difference (Net)|-0.94||||0.543||95.0|-3.98|2.1|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755932|NCT00261495|3225883|Superiority or Other||Mean Difference (Net)|1.17||||0.595||95.0|-3.15|5.49|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755933|NCT00261495|3225884|Superiority or Other||Mean Difference (Net)|1.31||||0.669||95.0|-4.72|7.34|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755934|NCT00261495|3225885|Superiority or Other||Mean Difference (Net)|0.21||||0.955||95.0|-7.2|7.62|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755935|NCT00261495|3225886|Superiority or Other||Mean Difference (Net)|4.05||||0.01||95.0|0.94|7.16|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755936|NCT00261495|3225887|Superiority or Other||Mean Difference (Net)|-1.3||||0.414||95.0|-4.45|1.84|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755937|NCT00261495|3225888|Superiority or Other||Mean Difference (Net)|-0.03||||0.627||95.0|-0.17|0.1|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755938|NCT00261495|3225889|Superiority or Other||Mean Difference (Net)|0.65||||0.647||95.0|-2.14|3.44|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755939|NCT00261495|3225890|Superiority or Other||Mean Difference (Net)|-0.9||||0.602||95.0|-4.27|2.48|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755940|NCT00261495|3225891|Superiority or Other||Mean Difference (Net)|-2.46||||0.123||95.0|-5.6|0.68|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755941|NCT00261495|3225892|Superiority or Other||Mean Difference (Net)|-2.98||||0.207||95.0|-7.63|1.66|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755942|NCT00261495|3225893|Superiority or Other||Mean Difference (Net)|-2.12||||0.551||95.0|-9.11|4.88|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755943|NCT00261495|3225894|Superiority or Other||Mean Difference (Net)|2.4||||0.556||95.0|-5.61|10.42|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755944|NCT00261495|3225895|Superiority or Other||Mean Difference (Net)|3.84||||0.025||95.0|0.48|7.19|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755945|NCT00261495|3225896|Superiority or Other||Mean Difference (Net)|-1.13||||0.471||95.0|-4.2|1.95|||ANCOVA||Mean difference calculated: hydromorphone minus oxymorphone|Exploratory comparison|
1755946|NCT00261495|3225897|Superiority or Other||Mean Difference (Net)|0.09||||0.299||95.0|-0.08|0.26|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755947|NCT00261495|3225898|Superiority or Other||Mean Difference (Net)|-0.08||||0.956||95.0|-3.08|2.91|||ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1756118|NCT00261443|3226002|Superiority or Other|||||||0.326|||||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo|
1755954|NCT00261495|3225909|Superiority or Other||Mean Difference (Net)|1.6||||0.475||95.0|-2.8|6.0||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755955|NCT00261495|3225910|Superiority or Other||Mean Difference (Net)|-3.35||||0.107||95.0|-7.43|0.73||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755956|NCT00261495|3225911|Superiority or Other||Mean Difference (Net)|2.41||||0.205||95.0|-1.32|6.14||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755957|NCT00261495|3225912|Superiority or Other||Mean Difference (Net)|-2.03||||0.297||95.0|-5.85|1.8||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755958|NCT00261495|3225913|Superiority or Other||Mean Difference (Net)|-2.64||||0.071||95.0|-5.51|0.23||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755959|NCT00261495|3225914|Superiority or Other||Mean Difference (Net)|-1.89||||0.245||95.0|-5.09|1.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755960|NCT00261495|3225915|Superiority or Other||Mean Difference (Net)|-2.36||||0.169||95.0|-5.74|1.02||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755961|NCT00261495|3225917|Superiority or Other||Mean Difference (Net)|-0.03||||0.902||95.0|-0.51|0.45||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755962|NCT00261495|3225918|Superiority or Other||Mean Difference (Net)|0.01||||0.977||95.0|-0.47|0.49||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755963|NCT00261495|3225919|Superiority or Other||Mean Difference (Net)|-0.01||||0.977||95.0|-0.45|0.44||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755964|NCT00261495|3225920|Superiority or Other||Mean Difference (Net)|0.04||||0.843||95.0|-0.4|0.49||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755965|NCT00261495|3225921|Superiority or Other||Mean Difference (Net)|-0.06||||0.769||95.0|-0.49|0.36||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755966|NCT00261495|3225922|Superiority or Other||Mean Difference (Net)|-0.15||||0.526||95.0|-0.6|0.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755967|NCT00261495|3225923|Superiority or Other||Mean Difference (Net)|-0.11||||0.611||95.0|-0.52|0.3||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755968|NCT00261495|3225924|Superiority or Other||Mean Difference (Net)|0.23||||0.359||95.0|-0.26|0.72||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755969|NCT00261495|3225925|Superiority or Other||Mean Difference (Net)|0.17||||0.475||95.0|-0.31|0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755970|NCT00261495|3225926|Superiority or Other||Mean Difference (Net)|0.33||||0.171||95.0|-0.14|0.81||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755971|NCT00261495|3225927|Superiority or Other||Mean Difference (Net)|0.47||||0.042||95.0|0.02|0.93||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755972|NCT00261495|3225928|Superiority or Other||Mean Difference (Net)|0.14||||0.552||95.0|-0.33|0.61||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755973|NCT00261495|3225929|Superiority or Other||Mean Difference (Net)|0.21||||0.345||95.0|-0.23|0.64||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755974|NCT00261495|3225930|Superiority or Other||Mean Difference (Net)|0.3||||0.143||95.0|-0.1|0.71||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755975|NCT00261495|3225931|Superiority or Other||Mean Difference (Net)|-0.04||||0.832||95.0|-0.38|0.31||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755976|NCT00261495|3225932|Superiority or Other||Mean Difference (Net)|-0.51||||0.837||95.0|-5.36|4.35||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755977|NCT00261495|3225933|Superiority or Other||Mean Difference (Net)|-0.04||||0.835||95.0|-0.4|0.33||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755978|NCT00261495|3225934|Superiority or Other||Mean Difference (Net)|-0.15||||0.431||95.0|-0.52|0.22||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755979|NCT00261495|3225935|Superiority or Other||Mean Difference (Net)|0.31||||0.073||95.0|-0.03|0.65||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755980|NCT00261495|3225936|Superiority or Other||Mean Difference (Net)|-0.18||||0.941||95.0|-4.87|4.52||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755981|NCT00261495|3225937|Superiority or Other||Mean Difference (Net)|0.23||||0.21||95.0|-0.13|0.59||0.05 two-sided test|ANCOVA||Mean difference calculated: hdromorphone minus oxycodone|Exploratory comparison|
1755982|NCT00261495|3225938|Superiority or Other||Mean Difference (Net)|0.39||||0.058||95.0|-0.01|0.79||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755983|NCT00261495|3225939|Superiority or Other||Mean Difference (Net)|0.3||||0.105||95.0|-0.06|0.67||0.05 two-sided test|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755984|NCT00261495|3225940|Superiority or Other||Mean Difference (Net)|0.42||||0.05||95.0|0.0|0.84||0.05 two-sided testing, exploratory comparison|ANCOVA||Mean difference calculated: hydromorphone minus oxycodone|Exploratory comparison|
1755996|NCT00261443|3225963|Superiority or Other|||||||0.771||||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference|
1755985|NCT00261495|3225941|Superiority or Other|||||||0.249||||||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Hierarchical testing procedure has been stopped, test is exploratory in nature.|Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel Chi-squared statistic stratified for country was used.||"Null hypothesis: There is no association between study medication and dose escalation.~Alternative hypothesis: There is an association between study medication and dose escalation."|
1755986|NCT00261495|3225942|Superiority or Other||Mean Difference (Net)|-0.11||||0.616||95.0|-0.54|0.32||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference was calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."|
1755987|NCT00261495|3225943|Superiority or Other||Mean Difference (Net)|-0.2||||0.348||95.0|-0.62|0.22||A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference was calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."|
1755988|NCT00261495|3225944|Superiority or Other||Mean Difference (Net)|-2.87||||0.065||95.0|-5.94|0.19||A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."|
1755989|NCT00261495|3225945|Non-Inferiority or Equivalence|Tested using 95% confidence interval approach. The non-inferiority margin was 1.|Mean Difference (Net)|-0.12|||<|0.001||95.0|-0.53|0.29||Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means & error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).|ANCOVA|If the right side of CI<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.~Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.~Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power)."|
1755990|NCT00261495|3225946|Superiority or Other||Mean Difference (Net)|0.08||||0.706||95.0|-0.32|0.47||A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure was stopped here, subsequent tests were exploratory in nature.|ANCOVA|Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.|Mean difference calculated: hydromorphone minus oxycodone|"Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.~Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero."|
1755991|NCT00261495|3225947|Non-Inferiority or Equivalence|Tested using 95% confidence interval approach. The non-inferiority margin was 1.|Mean Difference (Net)|0.29||||0.011||95.0|-0.27|0.84||Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means & error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).|ANCOVA|If the right side of CI<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.|LS mean difference has been presented, which was calculated as hydromorphone minus oxycodone.|"Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.~Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.~Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power)."|
1755992|NCT00261443|3225961|Superiority or Other||Median Difference (Final Values)|0.04||||0.444|2-Sided|95.0|-0.06|0.14||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change, Treatment Difference|
1755993|NCT00261443|3225961|Superiority or Other||Mean Difference (Final Values)|0.01||||0.774|2-Sided|95.0|-0.06|0.08||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference|
1755994|NCT00261443|3225962|Superiority or Other||Mean Difference (Final Values)|0.02||||0.636|2-Sided|95.0|-0.05|0.08||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value treatment Difference|
1755995|NCT00261443|3225962|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.576|2-Sided|95.0|-0.05|0.03||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference|
1756023|NCT00261443|3225972|Superiority or Other|||||||0.213||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QTc Bazett|
1755997|NCT00261443|3225963|Superiority or Other||Mean Difference (Final Values)|0.0||||0.808|2-Sided|95.0|-0.03|0.04||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference|
1755998|NCT00261443|3225964|Superiority or Other||Mean Difference (Final Values)|0.04||||0.222|2-Sided|95.0|-0.03|0.11||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference|
1755999|NCT00261443|3225964|Superiority or Other||Mean Difference (Final Values)|0.0||||0.904|2-Sided|95.0|-0.04|0.04||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference|
1756000|NCT00261443|3225965|Superiority or Other||Mean Difference (Final Values)|0.12||||0.362|2-Sided|95.0|-0.14|0.38||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value of Change Treatment Difference|
1756001|NCT00261443|3225965|Superiority or Other||Mean Difference (Final Values)|0.06||||0.514|2-Sided|95.0|-0.12|0.23||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference|
1756002|NCT00261443|3225966|Superiority or Other|||||||0.253||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Heart Rate, Phase 3|
1756003|NCT00261443|3225966|Superiority or Other|||||||0.405||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Heart Rate, Phase 3|
1756004|NCT00261443|3225966|Superiority or Other|||||||0.386||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in Heart Rate at Week 52 (LOCF)|
1756005|NCT00261443|3225966|Superiority or Other|||||||0.587||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Heart Rate|
1756006|NCT00261443|3225967|Superiority or Other||Mean Difference (Final Values)|0.36||||0.012|2-Sided|95.0|0.08|0.64||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value in Change Treatment Difference|
1756007|NCT00261443|3225967|Superiority or Other||Mean Difference (Final Values)|0.1||||0.235|2-Sided|95.0|-0.07|0.27||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 LOCF Treatment Difference|
1756008|NCT00261443|3225968|Superiority or Other|||||||0.372||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QRS, Phase 3|
1756009|NCT00261443|3225968|Superiority or Other|||||||0.545||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QRS at Week 52 (LOCF)|
1756010|NCT00261443|3225968|Superiority or Other|||||||0.826||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QRS|
1756011|NCT00261443|3225969|Superiority or Other|||||||0.435||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Prolactin, Phase 3 Safety Sample|
1756012|NCT00261443|3225969|Superiority or Other|||||||0.204||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in RR, Phase 3 Safety Sample|
1756013|NCT00261443|3225969|Superiority or Other|||||||0.353||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in RR at Week 52 (LOCF)|
1756014|NCT00261443|3225969|Superiority or Other|||||||0.571||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline RR|
1756015|NCT00261443|3225970|Superiority or Other|||||||0.128||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in PR, Phase 3|
1756016|NCT00261443|3225970|Superiority or Other|||||||0.027||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in PR at Week 52 (LOCF)|
1756017|NCT00261443|3225970|Superiority or Other|||||||0.012||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline PR|
1756018|NCT00261443|3225971|Superiority or Other|||||||0.072||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QTc (0.33), Phase 3|
1756019|NCT00261443|3225971|Superiority or Other|||||||0.669||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QTc (0.33) at Week 52 (LOCF)|
1756020|NCT00261443|3225971|Superiority or Other|||||||0.205||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline QTc (0.33)|
1756021|NCT00261443|3225972|Superiority or Other|||||||0.107||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in QTc Bazett, Phase 3|
1756022|NCT00261443|3225972|Superiority or Other|||||||0.708||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline in QTc Bazett at Week 52 (LOCF)|
1756024|NCT00261443|3225974|Superiority or Other|||||||0.505||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Lowest Value of Change in Leukocytes, Phase 3|
1756025|NCT00261443|3225974|Superiority or Other|||||||0.735||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Highest Value of Change in Leukocytes, Phase 3|
1756026|NCT00261443|3225974|Superiority or Other|||||||0.295||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)|
1756027|NCT00261443|3225974|Superiority or Other|||||||0.124||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Leukocytes|
1756028|NCT00261443|3225975|Superiority or Other|||||||0.799||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Uric Acid, Phase 3 Safety Sample|
1756029|NCT00261443|3225975|Superiority or Other|||||||0.35||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)|
1756030|NCT00261443|3225975|Superiority or Other|||||||0.189||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Uric Acid|
1756031|NCT00261443|3225976|Superiority or Other|||||||0.415||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Triglycerides (fasting), Phase 3 Safety Sample|
1756032|NCT00261443|3225976|Superiority or Other|||||||0.489||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)|
1756033|NCT00261443|3225976|Superiority or Other|||||||0.273||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Triglycerides (fasting)|
1756034|NCT00261443|3225977|Superiority or Other|||||||0.592||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample|
1756035|NCT00261443|3225977|Superiority or Other|||||||0.675||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)|
1756036|NCT00261443|3225977|Superiority or Other|||||||0.63||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Total Bilirubin|
1756037|NCT00261443|3225978|Superiority or Other|||||||0.004||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Prolactin, Phase 3 Safety Sample|
1756038|NCT00261443|3225978|Superiority or Other||||||<|0.001||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison, Change from Baseline at Week 52 (LOCF)|
1756039|NCT00261443|3225978|Superiority or Other||||||<|0.412||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Prolactin|
1756040|NCT00261443|3225979|Superiority or Other|||||||0.541||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Platelet Count, Phase 3 Safety Sample|
1756041|NCT00261443|3225979|Superiority or Other|||||||0.358||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Platelet Count, Phase 3 Safety Sample|
1756042|NCT00261443|3225979|Superiority or Other|||||||0.322||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)|
1756043|NCT00261443|3225979|Superiority or Other|||||||0.663||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline in Platelet Count|
1756044|NCT00261443|3225980|Superiority or Other|||||||0.323||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Neutrophils (relative), Phase 3 Safety Sample|
1756045|NCT00261443|3225980|Superiority or Other|||||||0.486||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison in change from Baseline in Neutrophils (relative) at Week 52 (LOCF)|
1756046|NCT00261443|3225980|Superiority or Other|||||||0.967||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Neutrophils (relative)|
1756047|NCT00261443|3225981|Superiority or Other|||||||0.948||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Change Value in LDL Cholesterol (fasting)|
1756048|NCT00261443|3225981|Superiority or Other|||||||0.507||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline at Week 52 (LOCF)|
1756049|NCT00261443|3225981|Superiority or Other|||||||0.808||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline LDL Cholesterol (fasting)|
1756050|NCT00261443|3225982|Superiority or Other|||||||0.091||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Lactate Dehydrogenase During Phase 3|
1756051|NCT00261443|3225982|Superiority or Other|||||||0.034||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Lactate Dehydrogenase|
1756052|NCT00261443|3225982|Superiority or Other|||||||0.004||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Lactate Dehydrogenase|
1756053|NCT00261443|3225983|Superiority or Other|||||||0.87||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample|
1756054|NCT00261443|3225983|Superiority or Other|||||||0.554||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HOMA2-IR at Week 52 (LOCF)|
1756055|NCT00261443|3225983|Superiority or Other|||||||0.55||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HOMA2-IR|
1756056|NCT00261443|3225984|Superiority or Other|||||||0.329||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value in HOMA2-Percent Beta During Phase 3|
1756090|NCT00261443|3225995|Superiority or Other|||||||0.948||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change in ALT at Week 52 (LOCF)|
1756057|NCT00261443|3225984|Superiority or Other|||||||0.624||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HOMA2-Percent Beta at Week 52 (LOCF)|
1756058|NCT00261443|3225984|Superiority or Other|||||||0.349||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HOMA2-Percent Beta|
1756059|NCT00261443|3225985|Superiority or Other|||||||0.342||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in HDL Cholesterol (fasting) During Phase 3|
1756060|NCT00261443|3225985|Superiority or Other|||||||0.95||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in HDL Cholesterol (fasting) at Week 52 (LOCF)|
1756061|NCT00261443|3225985|Superiority or Other|||||||0.18||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline HDL Cholesterol (fasting)|
1756062|NCT00261443|3225986|Superiority or Other|||||||0.494||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Value of Change in Hematocrit During Phase 3|
1756063|NCT00261443|3225986|Superiority or Other|||||||0.377||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Hematocrit During Week 52 (LOCF)|
1756064|NCT00261443|3225986|Superiority or Other|||||||0.187||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Hematocrit|
1756065|NCT00261443|3225987|Superiority or Other|||||||0.299||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Lowest Change Value in Hemoglobin During Phase 3|
1756066|NCT00261443|3225987|Superiority or Other|||||||0.868||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Hemoglobin at Week 52 (LOCF)|
1756067|NCT00261443|3225987|Superiority or Other|||||||0.08||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Hemoglobin|
1756068|NCT00261443|3225988|Superiority or Other|||||||0.592||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Change Value in Glucose (fasting) During Phase 3|
1756069|NCT00261443|3225988|Superiority or Other|||||||0.962||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Glucose (fasting) at Week 52 (LOCF)|
1756070|NCT00261443|3225988|Superiority or Other|||||||0.741||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Glucose (fasting)|
1756071|NCT00261443|3225989|Superiority or Other|||||||0.511||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Eosinophils (relative) During Phase 3|
1756072|NCT00261443|3225989|Superiority or Other|||||||0.834||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Eosinophils (relative) at Week 52 (LOCF)|
1756073|NCT00261443|3225989|Superiority or Other|||||||0.507||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Eosinophils (relative)|
1756074|NCT00261443|3225990|Superiority or Other|||||||0.958||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Creatinine During Phase 3|
1756075|NCT00261443|3225990|Superiority or Other|||||||0.634||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Creatinine at Week 52 (LOCF)|
1756076|NCT00261443|3225990|Superiority or Other|||||||0.105||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Creatinine|
1756077|NCT00261443|3225991|Superiority or Other|||||||0.176||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Creatine Kinase During Phase 3|
1756078|NCT00261443|3225991|Superiority or Other|||||||0.019||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from baseline in Creatine Kinase at Week 52 (LOCF)|
1756079|NCT00261443|3225991|Superiority or Other|||||||0.043||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Creatine Kinase|
1756080|NCT00261443|3225992|Superiority or Other|||||||0.658||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Highest Value of Change in Total Cholesterol (fasting) in Phase 3|
1756081|NCT00261443|3225992|Superiority or Other|||||||0.544||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in Total Cholesterol (fasting) at Week 52 (LOCF)|
1756082|NCT00261443|3225992|Superiority or Other|||||||0.878||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline Total Cholesterol (fasting)|
1756083|NCT00261443|3225993|Superiority or Other|||||||0.169||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison BUN Highest Value of Change During Phase 3|
1756084|NCT00261443|3225993|Superiority or Other|||||||0.532||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in BUN at Week 52 (LOCF)|
1756085|NCT00261443|3225993|Superiority or Other|||||||0.118||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline BUN|
1756086|NCT00261443|3225994|Superiority or Other|||||||0.918||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison AST Highest Change Value During Phase 3|
1756087|NCT00261443|3225994|Superiority or Other|||||||0.255||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change in AST at Week 52 (LOCF)|
1756088|NCT00261443|3225994|Superiority or Other|||||||0.077||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline AST|
1756089|NCT00261443|3225995|Superiority or Other|||||||0.559||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison ALT Highest Change Value During Phase 3|
1759151|NCT00191152|3230714|Superiority or Other|||||||0.361|||||||Log Rank||||
1756091|NCT00261443|3225995|Superiority or Other|||||||0.111||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline ALT|
1756092|NCT00261443|3225996|Superiority or Other|||||||0.298||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison ALP Highest Change Value During Phase 3|
1756093|NCT00261443|3225996|Superiority or Other|||||||0.353||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Change from Baseline in ALP at Week 52 (LOCF)|
1756094|NCT00261443|3225996|Superiority or Other|||||||0.331||||||Wilcoxon Rank Sum Test stratified by mood stabilizer|Wilcoxon Rank Sum Test|||Treatment Comparison Baseline ALP|
1756095|NCT00261443|3225998|Superiority or Other|||||||0.046||||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Lowest Value Treatment Comparison|
1756096|NCT00261443|3225998|Superiority or Other|||||||0.31||||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Highest Value Treatment Comparison|
1756097|NCT00261443|3225998|Superiority or Other|||||||0.064||||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 52 (LOCF) Treatment Comparison|
1756098|NCT00261443|3225998|Superiority or Other|||||||0.374||||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 52 Treatment Comparison|
1756099|NCT00261443|3225998|Superiority or Other|||||||0.325||||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 36 Treatment Comparison|
1756100|NCT00261443|3225998|Superiority or Other|||||||0.485||||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 24 Treatment Comparison|
1756101|NCT00261443|3225998|Superiority or Other|||||||0.006||||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Week 12 Treatment Comparison|
1756102|NCT00261443|3225998|Superiority or Other|||||||0.646||||||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model on the rank of the change from baseline, controlling for treatment, mood stabilizer, and the rank of baseline is used for change from baseline.|ANOVA/ANCOVA|||Treatment Comparison Baseline|
1756103|NCT00261443|3225999|Superiority or Other||Risk Ratio (RR)|1.01||||0.987|2-Sided|95.0|0.54|1.86||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||"At Any Time Treatment Comparison"|
1756104|NCT00261443|3225999|Superiority or Other||Risk Ratio (RR)|0.78||||0.545|2-Sided|95.0|0.35|1.74||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 (LOCF) Treatment Comparison|
1756105|NCT00261443|3225999|Superiority or Other|||||||0.533||||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 Treatment Comparison|
1756106|NCT00261443|3225999|Superiority or Other|||||||0.805||||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 36 Treatment Comparison|
1756107|NCT00261443|3225999|Superiority or Other|||||||0.792||||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 24 Treatment Comparison|
1756108|NCT00261443|3225999|Superiority or Other|||||||0.685||||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 12 Treatment Comparison|
1756109|NCT00261443|3226000|Superiority or Other||Risk Ratio (RR)|1.26||||0.369|2-Sided|95.0|0.76|2.08||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||"At Any Time Treatment Comparison"|
1756110|NCT00261443|3226000|Superiority or Other||Risk Ratio (RR)|1.17||||0.584|2-Sided|95.0|0.66|2.09||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 (LOCF) Treatment Comparison|
1756111|NCT00261443|3226000|Superiority or Other|||||||0.928||||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 52 Treatment Comparison|
1756112|NCT00261443|3226000|Superiority or Other|||||||0.329||||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 36 Treatment Comparison|
1756113|NCT00261443|3226000|Superiority or Other|||||||0.247||||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 24 Treatment Comparison|
1756114|NCT00261443|3226000|Superiority or Other|||||||0.279||||||CMH General Association Test controlling for mood stabilizer.|Cochran-Mantel-Haenszel|||Week 12 Treatment Comparison|
1756115|NCT00261443|3226001|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.945|2-Sided|95.0|-1.21|1.12||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Highest Value Treatment Difference|
1756116|NCT00261443|3226001|Superiority or Other||Mean Difference (Final Values)|0.47||||0.491|2-Sided|95.0|-0.87|1.81||ANOVA model, controlling for treatment and mood stabilizer, is used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, and baseline value, is used for mean change from baseline.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences and p-values are based on the ANOVA/ANCOVA model.||Week 52 (LOCF) Treatment Difference|
1756117|NCT00261443|3226002|Superiority or Other|||||||0.201|||||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo|
1756281|NCT00260065|3226108|Superiority or Other||Percentage of Participants|52.0||||||95.0|41.3|61.7|||||||
1756119|NCT00261443|3226002|Superiority or Other|||||||0.709|||||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo|
1756120|NCT00261443|3226002|Superiority or Other|||||||0.85|||||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo|
1756121|NCT00261443|3226003|Superiority or Other|||||||0.753|||||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo|
1756122|NCT00261443|3226003|Superiority or Other|||||||0.527|||||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo|
1756123|NCT00261443|3226003|Superiority or Other|||||||0.174|||||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo|
1756124|NCT00261443|3226003|Superiority or Other|||||||0.935|||||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo|
1756125|NCT00261443|3226004|Superiority or Other|||||||0.519|||||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo|
1756126|NCT00261443|3226004|Superiority or Other|||||||0.295|||||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo|
1756127|NCT00261443|3226004|Superiority or Other|||||||0.362|||||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo|
1756128|NCT00261443|3226004|Superiority or Other|||||||0.871|||||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo|
1756129|NCT00261443|3226005|Superiority or Other|||||||0.757|||||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo|
1756130|NCT00261443|3226005|Superiority or Other|||||||0.665|||||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo|
1756131|NCT00261443|3226005|Superiority or Other|||||||0.707|||||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo|
1756132|NCT00261443|3226005|Superiority or Other|||||||0.916|||||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo|
1756133|NCT00261443|3226006|Superiority or Other|||||||0.542|||||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo|
1756134|NCT00261443|3226006|Superiority or Other|||||||0.022|||||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo|
1756135|NCT00261443|3226006|Superiority or Other|||||||0.11|||||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo|
1756136|NCT00261443|3226006|Superiority or Other|||||||0.142|||||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo|
1756137|NCT00261443|3226007|Superiority or Other|||||||0.206|||||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo|
1756138|NCT00261443|3226007|Superiority or Other|||||||0.02|||||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo|
1756139|NCT00261443|3226007|Superiority or Other|||||||0.073|||||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo|
1756140|NCT00261443|3226007|Superiority or Other|||||||0.184|||||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo|
1756141|NCT00261443|3226008|Superiority or Other|||||||0.481|||||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo|
1756142|NCT00261443|3226008|Superiority or Other|||||||0.284|||||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo|
1756143|NCT00261443|3226008|Superiority or Other|||||||0.868|||||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo|
1756144|NCT00261443|3226008|Superiority or Other|||||||0.619|||||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo|
1756145|NCT00261443|3226009|Superiority or Other|||||||0.578|||||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo|
1756146|NCT00261443|3226009|Superiority or Other|||||||0.532|||||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo|
1756147|NCT00261443|3226009|Superiority or Other|||||||0.045|||||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo|
1756148|NCT00261443|3226009|Superiority or Other|||||||0.656|||||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo|
1756149|NCT00261443|3226010|Superiority or Other|||||||0.707|||||||Wilcoxon Rank Sum Test|||Lowest Value Treatment Comparison; Aripiprazole/Placebo|
1756150|NCT00261443|3226010|Superiority or Other|||||||0.297|||||||Wilcoxon Rank Sum Test|||Highest Value Treatment Comparison; Aripiprazole/Placebo|
1756151|NCT00261443|3226010|Superiority or Other|||||||0.423|||||||Wilcoxon Rank Sum Test|||Week 52 LOCF Treatment Comparison; Aripiprazole/Placebo|
1756152|NCT00261443|3226010|Superiority or Other|||||||0.64|||||||Wilcoxon Rank Sum Test|||Baseline Treatment Comparison; Aripiprazole/Placebo|
1756153|NCT00261443|3226051|Superiority or Other||Cox Proportional Hazard|0.78||||0.132|2-Sided|95.0|0.56|1.08|||Stratified Log Rank Test|Stratified Log Rank Test p-value for equality of survival curves.|||
1756154|NCT00261443|3226052|Superiority or Other||Ratio of Remission Rate|1.06||||0.083|2-Sided|95.0|0.99|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 52|
1756155|NCT00261443|3226052|Superiority or Other||Ratio of Remission Rate|1.07||||0.017|2-Sided|95.0|1.01|1.15||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 48|
1756156|NCT00261443|3226052|Superiority or Other||Ratio of Remission Rate|1.06||||0.216|2-Sided|95.0|0.96|1.16||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 44|
1756157|NCT00261443|3226052|Superiority or Other||Ratio of Remission Rate|1.07||||0.021|2-Sided|95.0|1.01|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 40|
1756158|NCT00261443|3226052|Superiority or Other||Ratio of Remission Rate|1.05||||0.177|2-Sided|95.0|0.98|1.13||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 36|
1756282|NCT00260065|3226109|Superiority or Other||Percentage of Participants|33.0||||||95.0|24.2|43.5|||||||
1756159|NCT00261443|3226052|Superiority or Other||Ratio of Remission Rate|0.99||||0.756|2-Sided|95.0|0.93|1.05||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 32|
1756160|NCT00261443|3226052|Superiority or Other||Ratio of Remission Rate|1.08||||0.056|2-Sided|95.0|1.0|1.17||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 28|
1756161|NCT00261443|3226052|Superiority or Other||Ratio of Remission Rate|1.05||||0.09|2-Sided|95.0|0.99|1.11||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 24|
1756162|NCT00261443|3226052|Superiority or Other||Ratio of Remission Rate|1.05||||0.264|2-Sided|95.0|0.97|1.14||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 20|
1756163|NCT00261443|3226052|Superiority or Other||Ratio of Remission Rate|1.09||||0.015|2-Sided|95.0|1.02|1.17||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 16|
1756164|NCT00261443|3226052|Superiority or Other||Ratio of Remission Rate|1.01||||0.744|2-Sided|95.0|0.95|1.08||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 12|
1756165|NCT00261443|3226052|Superiority or Other||Ratio of Remission Rate|1.04||||0.3|2-Sided|95.0|0.97|1.11||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 8|
1756166|NCT00261443|3226052|Superiority or Other||Ratio of Remission Rate|1.0||||0.91|2-Sided|95.0|0.92|1.08||Cochran-Mantel-Haenszel General Association Test controlling for mood stabilizer and index mood episode.|Cochran-Mantel-Haenszel||Aripiprazole/Placebo|Week 4|
1756167|NCT00261443|3226053|Superiority or Other||Difference|-0.33||||0.073|2-Sided|95.0|-0.69|0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison|
1756168|NCT00261443|3226053|Superiority or Other||Difference|-0.36||||0.047|2-Sided|95.0|-0.72|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison|
1756169|NCT00261443|3226053|Superiority or Other||Difference|-0.29||||0.105|2-Sided|95.0|-0.64|0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison|
1756170|NCT00261443|3226053|Superiority or Other||Difference|-0.3||||0.091|2-Sided|95.0|-0.65|0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison|
1756171|NCT00261443|3226053|Superiority or Other||Difference|-0.33||||0.063|2-Sided|95.0|-0.68|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison|
1756172|NCT00261443|3226053|Superiority or Other||Difference|-0.33||||0.057|2-Sided|95.0|-0.67|0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison|
1756173|NCT00261443|3226053|Superiority or Other||Difference|-0.34||||0.047|2-Sided|95.0|-0.68|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison|
1756174|NCT00261443|3226053|Superiority or Other||Difference|-0.29||||0.088|2-Sided|95.0|-0.62|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison|
1756175|NCT00261443|3226053|Superiority or Other||Difference|-0.22||||0.196|2-Sided|95.0|-0.54|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison|
1756176|NCT00261443|3226053|Superiority or Other||Difference|-0.24||||0.141|2-Sided|95.0|-0.56|0.08||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison|
1756177|NCT00261443|3226053|Superiority or Other||Difference|-0.07||||0.653|2-Sided|95.0|-0.39|0.25||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison|
1756178|NCT00261443|3226053|Superiority or Other||Difference|-0.15||||0.349|2-Sided|95.0|-0.46|0.16||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison|
1756179|NCT00261443|3226053|Superiority or Other||Difference|0.1||||0.488|2-Sided|95.0|-0.19|0.4||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison|
1756180|NCT00261443|3226055|Superiority or Other||Difference|-0.12||||0.474|2-Sided|95.0|-0.43|0.2||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison|
1756181|NCT00261443|3226055|Superiority or Other||Difference|-0.14||||0.378|2-Sided|95.0|-0.46|0.17||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison|
1756182|NCT00261443|3226055|Superiority or Other||Difference|-0.03||||0.875|2-Sided|95.0|-0.34|0.29||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison|
1756183|NCT00261443|3226055|Superiority or Other||Difference|-0.07||||0.637|2-Sided|95.0|-0.39|0.24||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison|
1756184|NCT00261443|3226055|Superiority or Other||Difference|-0.1||||0.536|2-Sided|95.0|-0.41|0.21||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison|
1756185|NCT00261443|3226055|Superiority or Other||Difference|-0.2||||0.185|2-Sided|95.0|-0.51|0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison|
1756186|NCT00261443|3226055|Superiority or Other||Difference|-0.12||||0.418|2-Sided|95.0|-0.43|0.18||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison|
1756187|NCT00261443|3226055|Superiority or Other||Difference|-0.08||||0.572|2-Sided|95.0|-0.38|0.21||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison|
1756188|NCT00261443|3226055|Superiority or Other||Difference|-0.06||||0.705|2-Sided|95.0|-0.34|0.23||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison|
1756189|NCT00261443|3226055|Superiority or Other||Difference|-0.07||||0.65|2-Sided|95.0|-0.35|0.22||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison|
1756190|NCT00261443|3226055|Superiority or Other||Difference|-0.06||||0.665|2-Sided|95.0|-0.34|0.22||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison|
1756283|NCT00259298|3226122|Superiority or Other|||||||0.002||||||p-value is for change at 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in whole skeletal plasma clearance of 99m Tc-MDP from baseline to 18 months.|
1756191|NCT00261443|3226055|Superiority or Other||Difference|-0.04||||0.793|2-Sided|95.0|-0.3|0.23||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison|
1756192|NCT00261443|3226055|Superiority or Other||Difference|0.09||||0.486|2-Sided|95.0|-0.17|0.36||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison|
1756193|NCT00261443|3226057|Superiority or Other||Difference|-0.4||||0.023|2-Sided|95.0|-0.75|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison|
1756194|NCT00261443|3226057|Superiority or Other||Difference|-0.4||||0.022|2-Sided|95.0|-0.74|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison|
1756195|NCT00261443|3226057|Superiority or Other||Difference|-0.37||||0.029|2-Sided|95.0|-0.71|-0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison|
1756196|NCT00261443|3226057|Superiority or Other||Difference|-0.37||||0.027|2-Sided|95.0|-0.7|-0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison|
1756197|NCT00261443|3226057|Superiority or Other||Difference|-0.43||||0.011|2-Sided|95.0|-0.76|-0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison|
1756198|NCT00261443|3226057|Superiority or Other||Difference|-0.31||||0.062|2-Sided|95.0|-0.64|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison|
1756199|NCT00261443|3226057|Superiority or Other||Difference|-0.36||||0.033|2-Sided|95.0|-0.69|-0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison|
1756200|NCT00261443|3226057|Superiority or Other||Difference|-0.29||||0.082|2-Sided|95.0|-0.62|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison|
1756201|NCT00261443|3226057|Superiority or Other||Difference|-0.27||||0.095|2-Sided|95.0|-0.58|0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison|
1756202|NCT00261443|3226057|Superiority or Other||Difference|-0.29||||0.068|2-Sided|95.0|-0.59|0.02||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison|
1756203|NCT00261443|3226057|Superiority or Other||Difference|-0.12||||0.465|2-Sided|95.0|-0.43|0.2||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison|
1756204|NCT00261443|3226057|Superiority or Other||Difference|-0.19||||0.213|2-Sided|95.0|-0.49|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison|
1756284|NCT00259298|3226124|Superiority or Other|||||||1||||||p-value is for focal change, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 18 months.|
1756205|NCT00261443|3226057|Superiority or Other||Difference|0.04||||0.774|2-Sided|95.0|-0.25|0.33||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison|
1756206|NCT00261443|3226060|Superiority or Other||Difference|-0.22||||0.085|2-Sided|95.0|-0.46|0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison|
1756207|NCT00261443|3226060|Superiority or Other||Difference|-0.23||||0.06|2-Sided|95.0|-0.48|0.01||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison|
1756208|NCT00261443|3226060|Superiority or Other||Difference|-0.18||||0.152|2-Sided|95.0|-0.42|0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison|
1756209|NCT00261443|3226060|Superiority or Other||Difference|-0.19||||0.132|2-Sided|95.0|-0.43|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison|
1756210|NCT00261443|3226060|Superiority or Other||Difference|-0.17||||0.174|2-Sided|95.0|-0.41|0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison|
1756211|NCT00261443|3226060|Superiority or Other||Difference|-0.26||||0.034|2-Sided|95.0|-0.5|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison|
1756212|NCT00261443|3226060|Superiority or Other||Difference|-0.22||||0.073|2-Sided|95.0|-0.46|0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison|
1756213|NCT00261443|3226060|Superiority or Other||Difference|-0.17||||0.135|2-Sided|95.0|-0.4|0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison|
1756214|NCT00261443|3226060|Superiority or Other||Difference|-0.13||||0.251|2-Sided|95.0|-0.35|0.09||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison|
1756215|NCT00261443|3226060|Superiority or Other||Difference|-0.11||||0.305|2-Sided|95.0|-0.31|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison|
1756216|NCT00261443|3226060|Superiority or Other||Difference|-0.14||||0.159|2-Sided|95.0|-0.34|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison|
1756217|NCT00261443|3226060|Superiority or Other||Difference|-0.11||||0.266|2-Sided|95.0|-0.3|0.08||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison|
1756218|NCT00261443|3226060|Superiority or Other||Difference|-0.01||||0.922|2-Sided|95.0|-0.18|0.16||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison|
1756219|NCT00261443|3226060|Superiority or Other||Difference|0.04||||0.588|2-Sided|95.0|-0.09|0.16||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison|
1756285|NCT00259298|3226124|Superiority or Other|||||||1||||||p-value is for focal change, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 3 months.|
1756220|NCT00261443|3226062|Superiority or Other||Difference|-0.35||||0.015|2-Sided|95.0|-0.62|-0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison|
1756221|NCT00261443|3226062|Superiority or Other||Difference|-0.39||||0.006|2-Sided|95.0|-0.67|-0.12||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison|
1756222|NCT00261443|3226062|Superiority or Other||Difference|-0.34||||0.015|2-Sided|95.0|-0.62|-0.07||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison|
1756223|NCT00261443|3226062|Superiority or Other||Difference|-0.29||||0.038|2-Sided|95.0|-0.56|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison|
1756224|NCT00261443|3226062|Superiority or Other||Difference|-0.29||||0.035|2-Sided|95.0|-0.56|-0.02||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison|
1756225|NCT00261443|3226062|Superiority or Other||Difference|-0.31||||0.024|2-Sided|95.0|-0.57|-0.04||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison|
1756226|NCT00261443|3226062|Superiority or Other||Difference|-0.29||||0.029|2-Sided|95.0|-0.56|-0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison|
1756227|NCT00261443|3226062|Superiority or Other||Difference|-0.31||||0.018|2-Sided|95.0|-0.56|-0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison|
1756228|NCT00261443|3226062|Superiority or Other||Difference|-0.21||||0.092|2-Sided|95.0|-0.46|0.04||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison|
1756229|NCT00261443|3226062|Superiority or Other||Difference|-0.18||||0.133|2-Sided|95.0|-0.41|0.05||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison|
1756230|NCT00261443|3226062|Superiority or Other||Difference|-0.14||||0.219|2-Sided|95.0|-0.37|0.08||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison|
1756231|NCT00261443|3226062|Superiority or Other||Difference|-0.11||||0.291|2-Sided|95.0|-0.32|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison|
1756232|NCT00261443|3226062|Superiority or Other||Difference|0.02||||0.838|2-Sided|95.0|-0.17|0.21||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison|
1756233|NCT00261443|3226062|Superiority or Other||Difference|0.05||||0.597|2-Sided|95.0|-0.13|0.22||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison|
1756234|NCT00261443|3226064|Superiority or Other||Difference|-2.01||||0.019|2-Sided|95.0|-3.68|-0.34||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison|
1756286|NCT00259298|3226125|Superiority or Other|||||||0.0273||||||p-value is for lower extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the lower extremities from 18 months to 24 months.|
1756235|NCT00261443|3226064|Superiority or Other||Difference|-2.08||||0.014|2-Sided|95.0|-3.73|-0.43||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison|
1756236|NCT00261443|3226064|Superiority or Other||Difference|-1.57||||0.066|2-Sided|95.0|-3.24|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison|
1756237|NCT00261443|3226064|Superiority or Other||Difference|-1.53||||0.066|2-Sided|95.0|-3.16|0.1||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison|
1756238|NCT00261443|3226064|Superiority or Other||Difference|-1.15||||0.164|2-Sided|95.0|-2.77|0.47||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison|
1756239|NCT00261443|3226064|Superiority or Other||Difference|-1.62||||0.046|2-Sided|95.0|-3.21|-0.03||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison|
1756240|NCT00261443|3226064|Superiority or Other||Difference|-1.51||||0.06|2-Sided|95.0|-3.07|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison|
1756241|NCT00261443|3226064|Superiority or Other||Difference|-1.43||||0.061|2-Sided|95.0|-2.92|0.06||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison|
1756242|NCT00261443|3226064|Superiority or Other||Difference|-1.13||||0.125|2-Sided|95.0|-2.59|0.32||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison|
1756243|NCT00261443|3226064|Superiority or Other||Difference|-0.85||||0.205|2-Sided|95.0|-2.16|0.47||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison|
1756244|NCT00261443|3226064|Superiority or Other||Difference|-1.0||||0.128|2-Sided|95.0|-2.28|0.29||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison|
1756245|NCT00261443|3226064|Superiority or Other||Difference|-1.04||||0.113|2-Sided|95.0|-2.33|0.25||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison|
1756246|NCT00261443|3226064|Superiority or Other||Difference|-0.5||||0.371|2-Sided|95.0|-1.59|0.6||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison|
1756247|NCT00261443|3226064|Superiority or Other||Difference|0.2||||0.59|2-Sided|95.0|-0.54|0.94||Baseline: ANOVA model, controlling for treatment, mood stabilizer, and index mood episode. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison|
1756248|NCT00261443|3226066|Superiority or Other||Difference|-3.04|||<|0.001|2-Sided|95.0|-4.55|-1.54||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison|
1756249|NCT00261443|3226066|Superiority or Other||Difference|-3.08|||<|0.001|2-Sided|95.0|-4.59|-1.57||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison|
1756312|NCT00259298|3226125|Superiority or Other|||||||0.0078||||||p-value is for skull, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from 3 months to 18 months.|
1756250|NCT00261443|3226066|Superiority or Other||Difference|-2.92|||<|0.001|2-Sided|95.0|-4.38|-1.46||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison|
1756251|NCT00261443|3226066|Superiority or Other||Difference|-2.71|||<|0.001|2-Sided|95.0|-4.13|-1.29||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison|
1756252|NCT00261443|3226066|Superiority or Other||Difference|-2.78|||<|0.001|2-Sided|95.0|-4.19|-1.37||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison|
1756253|NCT00261443|3226066|Superiority or Other||Difference|-2.33|||<|0.001|2-Sided|95.0|-3.7|-0.95||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison|
1756254|NCT00261443|3226066|Superiority or Other||Difference|-2.62|||<|0.001|2-Sided|95.0|-4.06|-1.19||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison|
1756255|NCT00261443|3226066|Superiority or Other||Difference|-2.18|||<|0.001|2-Sided|95.0|-3.47|-0.89||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison|
1756256|NCT00261443|3226066|Superiority or Other||Difference|-1.91|||<|0.003|2-Sided|95.0|-3.15|-0.68||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison|
1756257|NCT00261443|3226066|Superiority or Other||Difference|-1.39|||<|0.017|2-Sided|95.0|-2.52|-0.25||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison|
1756258|NCT00261443|3226066|Superiority or Other||Difference|-1.1|||<|0.047|2-Sided|95.0|-2.19|-0.01||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison|
1756259|NCT00261443|3226066|Superiority or Other||Difference|-0.69|||<|0.144|2-Sided|95.0|-1.61|0.24||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison|
1756260|NCT00261443|3226066|Superiority or Other||Difference|0.06|||<|0.895|2-Sided|95.0|-0.83|0.95||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison|
1756261|NCT00261443|3226066|Superiority or Other||Difference|0.02|||<|0.955|2-Sided|95.0|-0.73|0.77||Mean change from baseline: ANOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value. Mean change from baseline: ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, baseline value.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison|
1756262|NCT00261443|3226068|Superiority or Other||Hazard Ratio (HR)|0.733||||0.384|2-Sided|95.0|0.364|1.479||Stratified Log-rank Test P-value for Equality of Survival Curves|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.||
1756263|NCT00261443|3226069|Superiority or Other||Hazard Ratio (HR)|0.348||||0.013|2-Sided|95.0|0.146|0.829||Stratified Log-rank Test, controlling for type of mood stabilizer and type of index mood episode.|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.||
1756264|NCT00261443|3226070|Superiority or Other||Difference|-0.28||||0.013|2-Sided|95.0|-0.5|-0.06||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 52 Comparison|
1759152|NCT00191152|3230715|Superiority or Other|||||||0.145|||||||Log Rank||||
1756265|NCT00261443|3226070|Superiority or Other||Difference|-0.29||||0.009|2-Sided|95.0|-0.5|-0.07||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 48 Comparison|
1756266|NCT00261443|3226070|Superiority or Other||Difference|-0.27||||0.015|2-Sided|95.0|-0.48|-0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 44 Comparison|
1756267|NCT00261443|3226070|Superiority or Other||Difference|-0.22||||0.039|2-Sided|95.0|-0.43|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 40 Comparison|
1756268|NCT00261443|3226070|Superiority or Other||Difference|-0.25||||0.017|2-Sided|95.0|-0.46|-0.05||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 36 Comparison|
1756269|NCT00261443|3226070|Superiority or Other||Difference|-0.19||||0.064|2-Sided|95.0|-0.4|0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 32 Comparison|
1756270|NCT00261443|3226070|Superiority or Other||Difference|-0.21||||0.05|2-Sided|95.0|-0.43|0.0||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 28 Comparison|
1756271|NCT00261443|3226070|Superiority or Other||Difference|-0.2||||0.039|2-Sided|95.0|-0.4|-0.01||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 24 Comparison|
1756272|NCT00261443|3226070|Superiority or Other||Difference|-0.16||||0.092|2-Sided|95.0|-0.35|0.03||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 20 Comparison|
1756273|NCT00261443|3226070|Superiority or Other||Difference|-0.13||||0.142|2-Sided|95.0|-0.3|0.04||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 16 Comparison|
1756274|NCT00261443|3226070|Superiority or Other||Difference|-0.05||||0.522|2-Sided|95.0|-0.22|0.11||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 12 Comparison|
1756275|NCT00261443|3226070|Superiority or Other||Difference|-0.04||||0.596|2-Sided|95.0|-0.18|0.1||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 8 Comparison|
1756276|NCT00261443|3226070|Superiority or Other||Difference|0.04||||0.557|2-Sided|95.0|-0.09|0.18||Mean change from baseline: ANOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline value. Mean change from preceding phase: ANCOVA controlling for treatment, mood stabilizer, type of index mood episode, baseline CGI-BP.|ANOVA/ANCOVA|Means, differences in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Week 4 Comparison|
1756277|NCT00261443|3226070|Superiority or Other||Difference|-0.01||||0.911|2-Sided|95.0|-0.16|0.15||ANOVA model, controlling for treatment, mood stabilizer, and index mood episode used for baseline. ANCOVA model, controlling for treatment, mood stabilizer, index mood episode, and baseline value used for mean change from baseline.|ANOVA/ANCOVA|Means, difference in means, 95% CI for the differences, and p-values are based on the ANOVA/ANCOVA model.||Aripiprazole - Placebo; Baseline Comparison|
1756278|NCT00261443|3226071|Superiority or Other||Hazard Ratio (HR)|0.544||||0.014|2-Sided|95.0|0.332|0.893||Stratified Log-rank Test, controlling for type of mood stabilizer and type of mood episode|Stratified Log-rank Test||Cox proportional hazards model, with type of mood stabilizer and type of index mood episode as stratification factors, and treatment group as covariate.||
1756279|NCT00260832|3226079|Superiority||Odds Ratio (OR)|2.5||||0.0011|2-Sided|95.0|1.4|4.78|||Fisher Exact||||
1756280|NCT00260832|3226080|Superiority or Other (legacy)|||||||0.1079|||||||Kaplan-Meier|||The primary treatment comparison was based on two sided long-rank test stratified by age, cytogenetic risk, ECOG performance status|
1756287|NCT00259298|3226125|Superiority or Other|||||||0.1934||||||p-value is for lower extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from 3 months to 18 months.|
1756288|NCT00259298|3226125|Superiority or Other|||||||0.4609||||||p-value is for lower extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 24 months.|
1756289|NCT00259298|3226125|Superiority or Other|||||||0.0098||||||p-value is for lower extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 18 months.|
1756290|NCT00259298|3226125|Superiority or Other|||||||0.0371||||||p-value is for lower extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the lower extremities from baseline to 3 months.|
1756291|NCT00259298|3226125|Superiority or Other|||||||0.3594||||||p-value is for upper extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the upper extremities from 18 months to 24 months.|
1756292|NCT00259298|3226125|Superiority or Other|||||||0.0273||||||p-value is for upper extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from 3 months to 18 months.|
1756293|NCT00259298|3226125|Superiority or Other|||||||0.0039||||||p-value is for upper extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 24 months.|
1756294|NCT00259298|3226125|Superiority or Other|||||||0.002||||||p-value is for upper extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 18 months.|
1756295|NCT00259298|3226125|Superiority or Other|||||||0.0098||||||p-value is for upper extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the upper extremities from baseline to 3 months.|
1756296|NCT00259298|3226125|Superiority or Other|||||||0.6523||||||p-value is for pelvis, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the pelvis from 18 months to 24 months.|
1756297|NCT00259298|3226125|Superiority or Other|||||||0.2324||||||p-value is for pelvis, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from 3 months to 18 months.|
1756298|NCT00259298|3226125|Superiority or Other|||||||0.6523||||||p-value is for pelvis, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 24 months.|
1756299|NCT00259298|3226125|Superiority or Other|||||||0.7695||||||p-value is for pelvis, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 18 months.|
1756300|NCT00259298|3226125|Superiority or Other|||||||0.1934||||||p-value is for pelvis, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the pelvis from baseline to 3 months.|
1756301|NCT00259298|3226125|Superiority or Other|||||||0.7344||||||p-value is for spine, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the spine from 18 months to 24 months.|
1756302|NCT00259298|3226125|Superiority or Other|||||||0.0273||||||p-value is for spine, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the spine from baseline to 24 months.|
1756303|NCT00259298|3226125|Superiority or Other|||||||0.0645||||||p-value is for spine, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 18 months.|
1756304|NCT00259298|3226125|Superiority or Other|||||||0.2324||||||p-value is for spine, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from baseline to 3 months.|
1756305|NCT00259298|3226125|Superiority or Other|||||||0.1934||||||p-value is for spine, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the spine from 3 months to 18 months.|
1756306|NCT00259298|3226125|Superiority or Other|||||||0.0469||||||p-value is for mandible, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the mandible from 18 months to 24 months.|
1756307|NCT00259298|3226125|Superiority or Other|||||||0.5625||||||p-value is for mandible, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from 3 months to 18 months.|
1756308|NCT00259298|3226125|Superiority or Other|||||||0.2969||||||p-value is for mandible, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 24 months.|
1756309|NCT00259298|3226125|Superiority or Other|||||||0.0313||||||p-value is for mandible, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 18 months.|
1756310|NCT00259298|3226125|Superiority or Other|||||||0.0391||||||p-value is for mandible, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the mandible from baseline to 3 months.|
1756311|NCT00259298|3226125|Superiority or Other|||||||0.0156||||||p-value is for skull, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal uptake of 99m Tc-MDP in the skull from 18 months to 24 months.|
1756369|NCT00259012|3226160|Superiority or Other|||||||0.019|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline|
1756313|NCT00259298|3226125|Superiority or Other|||||||0.0781||||||p-value is for skull, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal uptake of 99m Tc-MDP in the skull from baseline to 24 months.|
1756314|NCT00259298|3226125|Superiority or Other|||||||0.0078||||||p-value is for skull, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 18 months.|
1756315|NCT00259298|3226125|Superiority or Other|||||||0.0078||||||p-value is for skull, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the skull from baseline to 3 months.|
1756316|NCT00259298|3226125|Superiority or Other|||||||0.0078||||||p-value is for whole skeleton, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 18 months to 24 months.|
1756317|NCT00259298|3226125|Superiority or Other|||||||0.1641||||||p-value is for whole skeleton, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from 3 months to 18 months.|
1756318|NCT00259298|3226125|Superiority or Other|||||||0.6523||||||p-value is for whole skeleton, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 24 months.|
1756319|NCT00259298|3226125|Superiority or Other|||||||0.0039||||||p-value is for whole skeleton, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 18 months.|
1756320|NCT00259298|3226125|Superiority or Other|||||||0.0098||||||p-value is for whole skeleton, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 3 months.|
1756321|NCT00259298|3226126|Superiority or Other|||||||0.0039||||||p-value if for whole body, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the whole body from 18 months to 24 months.|
1756322|NCT00259298|3226126|Superiority or Other|||||||0.0273||||||p-value is for whole body, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from 3 months to 18 months.|
1756323|NCT00259298|3226126|Superiority or Other|||||||0.5703||||||p-value is for whole body, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 24 months.|
1756324|NCT00259298|3226126|Superiority or Other|||||||0.0039||||||p-value is for whole body, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 3 months.|
1756325|NCT00259298|3226126|Superiority or Other|||||||0.0039||||||p-value is for lower extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 18 months to 24 months.|
1756326|NCT00259298|3226126|Superiority or Other|||||||0.1934||||||p-value is for lower extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 3 months to 18 months.|
1756327|NCT00259298|3226126|Superiority or Other|||||||0.5703||||||p-value is for lower extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 24 months.|
1756328|NCT00259298|3226126|Superiority or Other|||||||0.0059||||||p-value is for lower extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 18 months.|
1756329|NCT00259298|3226126|Superiority or Other|||||||0.0195||||||p-value is for lower extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 3 months.|
1756330|NCT00259298|3226126|Superiority or Other|||||||0.0547||||||p-value is for upper extremities, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 18 months to 24 months.|
1756331|NCT00259298|3226126|Superiority or Other|||||||0.0273||||||p-value is for upper extremities, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 3 months to 18 months.|
1756332|NCT00259298|3226126|Superiority or Other|||||||0.0039||||||p-value is for upper extremities, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 24 months.|
1756333|NCT00259298|3226126|Superiority or Other|||||||0.002||||||p-value is for upper extremities, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 18 months.|
1756334|NCT00259298|3226126|Superiority or Other|||||||0.0137||||||p-value is for upper extremities, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 3 months.|
1756335|NCT00259298|3226126|Superiority or Other|||||||0.1641||||||p-value is for pelvis, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 18 months to 24 months.|
1756336|NCT00259298|3226126|Superiority or Other|||||||0.1934||||||p-value is for pelvis, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 3 months to 18 months.|
1756370|NCT00259012|3226160|Superiority or Other|||||||0.087|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline|
1756337|NCT00259298|3226126|Superiority or Other|||||||0.9102||||||p-value is for pelvis, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 24 months.|
1756338|NCT00259298|3226126|Superiority or Other|||||||0.1055||||||p-value is for pelvis, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 18 months.|
1756339|NCT00259298|3226126|Superiority or Other|||||||0.0488||||||p-value is for pelvis, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 3 months.|
1756340|NCT00259298|3226126|Superiority or Other|||||||0.3594||||||p-value is for spine, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the spine from 18 months to 24 months.|
1756341|NCT00259298|3226126|Superiority or Other|||||||0.0488||||||p-value is for spine, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from 3 months to 18 months.|
1756342|NCT00259298|3226126|Superiority or Other|||||||0.0547||||||p-value is for spine, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 24 months.|
1756343|NCT00259298|3226126|Superiority or Other|||||||0.0137||||||p-value is for spine, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 18 months.|
1756344|NCT00259298|3226126|Superiority or Other|||||||0.0371||||||p-value is for spine, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 3 months.|
1756345|NCT00259298|3226126|Superiority or Other|||||||0.0781||||||p-value is for mandible, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the mandible from 18 months to 24 months.|
1756346|NCT00259298|3226126|Superiority or Other|||||||0.4375||||||p-value is for mandible, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from 3 months to 18 months.|
1756347|NCT00259298|3226126|Superiority or Other|||||||0.1563||||||p-value is for mandible, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 24 months.|
1756348|NCT00259298|3226126|Superiority or Other|||||||0.0078||||||p-value is for mandible, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 18 months.|
1756349|NCT00259298|3226126|Superiority or Other|||||||0.0156||||||p-value is for mandible, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 3 months.|
1756350|NCT00259298|3226126|Superiority or Other|||||||0.0156||||||p-value is for skull, 18 months to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the skull from 18 months to 24 months.|
1756351|NCT00259298|3226126|Superiority or Other|||||||0.0078||||||p-value is for skull, 3 months to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from 3 months to 18 months.|
1756352|NCT00259298|3226126|Superiority or Other|||||||0.0313||||||p-value is for skull, baseline to 24 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 24 months.|
1756353|NCT00259298|3226126|Superiority or Other|||||||0.0078||||||p-value is for skull, baseline to 18 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 18 months.|
1756354|NCT00259298|3226126|Superiority or Other|||||||0.0078||||||p-value is for skull, baseline to 3 months|Wilcoxon signed rank test|||Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 3 months.|
1756355|NCT00259012|3226153|Superiority or Other|||||||0.021|||||||t-test, 2 sided|||Within group comparison between steady state and baseline|
1756356|NCT00259012|3226153|Superiority or Other|||||||0.387|||||||t-test, 2 sided|||Within group comparison between steady state and baseline|
1756357|NCT00259012|3226154|Superiority or Other|||||||0.119|||||||t-test, 2 sided|||Within group comparison between steady state and baseline|
1756358|NCT00259012|3226154|Superiority or Other|||||||0.166|||||||t-test, 2 sided|||Within group comparison between steady state and baseline|
1756359|NCT00259012|3226155|Superiority or Other|||||||0.534|||||||t-test, 2 sided|||Within group comparison between steady state and baseline|
1756360|NCT00259012|3226155|Superiority or Other|||||||0.982|||||||t-test, 2 sided|||Within group comparison between steady state and baseline|
1756361|NCT00259012|3226156|Superiority or Other|||||||0.003|||||||t-test, 2 sided|||Within group comparison between steady state and baseline|
1756362|NCT00259012|3226156|Superiority or Other|||||||0.339|||||||t-test, 2 sided|||Within group comparison between steady state and baseline|
1756363|NCT00259012|3226157|Superiority or Other|||||||0.012|||||||t-test, 2 sided|||Within group comparison between steady state and baseline|
1756364|NCT00259012|3226157|Superiority or Other|||||||0.347|||||||t-test, 2 sided|||Within group comparison between steady state and baseline|
1756365|NCT00259012|3226158|Superiority or Other|||||||0.016|||||||t-test, 2 sided|||Within group comparison between steady state and baseline|
1756366|NCT00259012|3226158|Superiority or Other|||||||0.099|||||||t-test, 2 sided|||Within group comparison between steady state and baseline|
1756367|NCT00259012|3226159|Superiority or Other|||||||0.031|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline.|
1756368|NCT00259012|3226159|Superiority or Other|||||||0.255|||||||t-test, 2 sided|paired||Within group comparison between steady state and baseline|
1756371|NCT00258674|3226194|Superiority or Other||Mean Difference (Final Values)|0.01||||0.685||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756372|NCT00258674|3226195|Superiority or Other||Mean Difference (Final Values)|0.01||||0.988||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756373|NCT00258674|3226196|Superiority or Other||Mean Difference (Final Values)|0.03||||0.382||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756374|NCT00258674|3226197|Superiority or Other||Median Difference (Final Values)|-0.01||||0.86||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756375|NCT00258674|3226198|Superiority or Other||Median Difference (Final Values)|0.04||||0.332||95.0||||A comparison of the claims vs. claims+MR arms was also conducted, giving a p-value of 0.537.|Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756376|NCT00258674|3226199|Superiority or Other||Median Difference (Final Values)|0.01||||0.936||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756377|NCT00258674|3226200|Superiority or Other||Median Difference (Final Values)|0.1||||0.447||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756378|NCT00258674|3226201|Superiority or Other||Median Difference (Final Values)|0.02||||0.451||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756379|NCT00258674|3226202|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.996||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756380|NCT00258674|3226203|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.413||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756381|NCT00258674|3226204|Superiority or Other||Mean Difference (Final Values)|-0.55||||0.702||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756382|NCT00258674|3226205|Superiority or Other||Mean Difference (Final Values)|-0.98||||0.807||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756491|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.4||||0.6882|2-Sided|95.0|-1.6|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 24|
1756383|NCT00258674|3226206|Superiority or Other||Mean Difference (Final Values)|0.05||||0.867||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756384|NCT00258674|3226207|Superiority or Other||Mean Difference (Final Values)|0.09||||0.308||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756385|NCT00258674|3226208|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.927||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756386|NCT00258674|3226209|Superiority or Other||Mean Difference (Final Values)|0.03||||0.551||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756387|NCT00258674|3226210|Superiority or Other||Mean Difference (Final Values)|0.03||||0.307||95.0|||||Regression, Logistic|||We used a three-stage hierarchical model estimate the effect of the interventions on the change in endpoint from baseline to follow-up. Change scores for dichotomous measures were scored as –1, 0, or 1, with a positive value indicating increased guideline adherence or increased incidence of that process. We used ordered logistic models to test the hypothesis that patients in the intervention groups were more likely to meet guidelines or to receive these processes of care.|
1756388|NCT00258310|3226224|Superiority or Other||proportion|0.74|||||2-Sided|95.0|0.59|0.9|||||||
1756389|NCT00258154|3226260|Non-Inferiority or Equivalence|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (Rotateq+INFANRIX hexa group minus Placebo+INFANRIX hexa group) for subjects who achieve serum antibody levels of ≥ 0.15 μg/mL greater than -10%.|Percentage point difference|-3.7||||0.015||95.0|-9.3|1.3|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method|Percentage point difference (RotaTeq – Placebo)||
1756390|NCT00258154|3226262|Non-Inferiority or Equivalence|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (Rotateq+INFANRIX hexa group minus Placebo+INFANRIX hexa group) for subjects who achieve serum antibody levels of ≥ 10 mIU/mL greater than -10%|Percentage point difference|0.0|||<|0.001||95.0|-3.7|3.6|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method|Percentage point difference (RotaTeq – Placebo)||
1756391|NCT00257920|3226275|Superiority or Other||Mean Difference (Final Values)|-0.005|Standard Error of the Mean|0.009||0.573||95.0|-0.024|0.014||No adjustment was made for multiple comparisons. A single hypothesis was tested by the primary efficacy analysis. All hypothesis tests were two-tailed and P-values <=0.050 were considered statistically significant.|ANOVA|||The null hypothesis was that there is no difference in mean calcium absorption between Zemplar and Hectorol. Approximately 42 subjects were to be randomized assuming 36 subjects would available in the per-protocol set. A sample size of 36 subjects has 80% power to detect a mean difference of -0.018 assuming the Zemplar group mean is 0.139, the Hectorol group mean is 0.157 and the STD is 0.037. The ANOVA model included effects for sequence, subject-within-sequence, period and treatment regimen.|
1756392|NCT00257920|3226276|Superiority or Other||Mean Difference (Final Values)|-0.004|Standard Error of the Mean|0.009||0.67||95.0|-0.023|0.015||No adjustment was made for multiple comparisons. A single hypothesis was tested by the primary efficacy analysis. All hypothesis tests were two-tailed and P-values <= 0.050 were considered statistically significant.|Mixed Models Analysis|||The null hypothesis was that there is no difference in the mean calcium absorption fraction between Zemplar Injection and Hectorol Injection. The power calculation applied to the primary efficacy analysis.|
1756393|NCT00257894|3226277|Superiority or Other|||||||0.21||||||For test of drug by time interaction effect|ANOVA|Medium effect size, eta squared = .061||Analysis of variance, group by time (Day 0 vs. Day 10).|
1756394|NCT00257894|3226278|Superiority or Other|||||||0.79||||||Effect size (eta squared) = 0|ANOVA|Interaction term of a group by time ANOVA|||
1756395|NCT00257894|3226279|Superiority or Other|||||||0.6||||||Effect size about zero (eta squared = .01)|ANOVA|Interaction term from a group by time ANOVA|||
1756396|NCT00257894|3226280|Superiority or Other|||||||0.57||||||Effect size close to zero (eta squared of .01)|ANOVA|Interaction effect term from group by time ANOVA|||
1756397|NCT00257660|3226283|Superiority or Other (legacy)||Odds Ratio (OR)|7.206|||<|0.0001||95.0|3.01|17.26||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.|odds ratio|The odds ratio represents the odds of success on Dysport versus Placebo stratified for strata and country||The number of participants considered treatment successes was analysed using a logistic model with treatment, strata (naive or non-naive) and center as factors in the model.|
1756426|NCT00257166|3226338|Superiority or Other||LS mean difference|-3.5857|Standard Error of the Mean|1.4184||0.0117|2-Sided|95.0|-6.3705|-0.8009|||ANCOVA|||Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.|
1756398|NCT00257660|3226284|Superiority or Other (legacy)||Mean Difference (Net)|4.66||||0.002||95.0|1.73|7.58||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.|ANCOVA|Treatment group, baseline SF-36 physical health summary score, center and previous treatment by botulinum toxin or not were fitted in ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)||
1756399|NCT00257660|3226285|Superiority or Other (legacy)||Mean Difference (Net)|3.65||||0.061||95.0|-0.17|7.47||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.|ANCOVA|Treatment group, baseline SF-36 mental health summary score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)||
1756400|NCT00257660|3226286|Superiority or Other (legacy)||Mean Difference (Net)|-7.05||||0.028||95.0|-13.3|-0.8||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 12) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)||
1756401|NCT00257660|3226287|Superiority or Other (legacy)||Mean Difference (Net)|-11.05||||0.007||95.0|-19.0|-3.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 12) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)||
1756402|NCT00257660|3226288|Superiority or Other (legacy)||Mean Difference (Net)|-16.0|||<|0.001||95.0|-24.2|-7.8||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)||
1756403|NCT00257660|3226289|Superiority or Other (legacy)||Mean Difference (Net)|-16.95|||<|0.001||95.0|-25.8|-8.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 8) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)||
1756404|NCT00257660|3226290|Superiority or Other (legacy)||Mean Difference (Net)|-14.2|||<|0.001||95.0|-22.3|-6.1||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.|ANCOVA|Treatment group, baseline Investigator VAS CD symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 4) excludes 3 subjects (and 8 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)||
1756405|NCT00257660|3226291|Superiority or Other (legacy)||Mean Difference (Net)|-15.2|||<|0.001||95.0|-24.0|-6.4||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.|ANCOVA|Treatment group, baseline Subject VAS symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|Analysis at baseline (and on change at Week 4) excludes 4 subjects (and 13 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)||
1756406|NCT00257660|3226292|Superiority or Other (legacy)||Mean Difference (Net)|-4.12||||0.019||95.0|-7.55|-0.68||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 12 analysis excludes the scores for the 27 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."||
1756407|NCT00257660|3226293|Superiority or Other (legacy)||Mean Difference (Net)|-8.81|||<|0.0001||95.0|-12.91|-4.71||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 8 analysis excludes the scores for the 24 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."||
1756488|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.3||||0.0339|2-Sided|95.0|0.2|4.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 36|
1756408|NCT00257660|3226294|Superiority or Other (legacy)||Mean Difference (Net)|-8.84|||<|0.0001|2-Sided|95.0|-12.94|-4.74||A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p<0.05 was considered significant.|ANCOVA|Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.|"Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the analysis at Week 4 excludes the scores for the 7 subjects who were not assessed.~Mean difference = difference in adjusted least squares mean (Dysport - Placebo)."||
1756409|NCT00257608|3226295|Superiority or Other||Hazard Ratio (HR)|0.917||||0.5341|2-Sided|95.0|0.698|1.205|||Log Rank||||
1756410|NCT00257608|3226301|Superiority or Other||Hazard Ratio, log|0.708||||0.0006|2-Sided|95.0|0.58|0.864|||Log Rank||||
1756411|NCT00257556|3226311|Superiority or Other||Mean Difference (Final Values)|-0.045||||||95.0|-0.17|0.26|||||A two-sided 95% continuity-corrected confidence interval for the difference in percentages, based on the normal approximation||
1756412|NCT00257309|3226315|Superiority or Other||Odds Ratio (OR)|0.69||||0.21|2-Sided|95.0|0.38|1.23||Unadjusted analysis|Chi-squared||||
1756413|NCT00257192|3226323|Superiority or Other||Least squares mean|1.34|Standard Error of the Mean|1.19||0.2613|2-Sided|95.0|-1.01|3.69||SAS PROC MIXED to fit a mixed model analysis of covariance with treatment and region as fixed effects and baseline score as covariate.|ANCOVA|Observed cases at Week 6.||Neurocognitive Index score at Week 6: difference from placebo|
1756414|NCT00257192|3226331|Superiority or Other||Least squares mean|-0.19|Standard Error of the Mean|0.14||0.182|2-Sided|95.0|-0.47|0.09||Mixed effects MMRM with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects.|ANOVA|||Difference from placebo|
1756415|NCT00257192|3226332|Superiority or Other||Least squares mean|-0.43|Standard Error of the Mean|0.58||0.4661|2-Sided|95.0|-1.57|0.72||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|||Negative score: difference from placebo|
1756416|NCT00257192|3226332|Superiority or Other||Least squares mean|-1.33|Standard Error of the Mean|0.65||0.0412|2-Sided|95.0|-2.61|-0.05||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|||Positive score: difference from placebo|
1756417|NCT00257192|3226333|Superiority or Other||Least squares mean|-2.57|Standard Error of the Mean|2.0||0.1987||95.0|-6.5|1.36||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).||Total score: difference from placebo|
1756418|NCT00257192|3226334|Superiority or Other||Least squares mean|-0.21|Standard Error of the Mean|0.14||0.1289|2-Sided|95.0|-0.48|0.06||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).||Difference from placebo|
1756419|NCT00257192|3226335|Superiority or Other||Least squares mean|-1.8|Standard Error of the Mean|1.26||0.153|2-Sided|95.0|-4.28|0.67||Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.|ANCOVA|P-value for final analysis is to be adjusted due to planned interim analysis (0.0462).||Sample size for 85% power 2-tailed 0.05 significance level based on expected difference of -5 with average within-group standard deviation=13 was 276 subjects (2 to 1 ratio of enrollment: 184 ziprasidone, 92 placebo). Interim analysis at 60 percent (%) enrollment (ITT population): may stop trial early for efficacy (2-sided p-value less than (<) 0.0124) or for futility (2-sided p-value greater than (>) 0.4772; The final analysis is to employ a 2-sided p-value <0.0462.|
1756420|NCT00257166|3226336|Superiority or Other||LS mean difference|-0.76|Standard Error of the Mean|0.21||0.0004|2-Sided|95.0|-1.18|-0.34|||ANCOVA|||Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects was used for the analysis.|
1756421|NCT00257166|3226337|Superiority or Other||LS mean difference|-0.6884|Standard Error of the Mean|0.1761||0.0001|2-Sided|95.0|-1.0342|-0.3426|||ANCOVA|||Change at Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.|
1756422|NCT00257166|3226337|Superiority or Other||LS mean difference|-0.6798|Standard Error of the Mean|0.1643|<|0.0001|2-Sided|95.0|-1.0024|-0.3572|||ANCOVA|||Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.|
1756423|NCT00257166|3226337|Superiority or Other||LS mean difference|-0.5596|Standard Error of the Mean|0.1355|<|0.0001|2-Sided|95.0|-0.8256|-0.2936|||ANCOVA|||Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.|
1756424|NCT00257166|3226337|Superiority or Other||LS mean difference|-0.3754|Standard Error of the Mean|0.0989|<|0.0002|2-Sided|95.0|-0.5696|-0.1812|||ANCOVA|||Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.|
1756425|NCT00257166|3226338|Superiority or Other||LS mean difference|-4.8665|Standard Error of the Mean|1.7154||0.0047|2-Sided|95.0|-8.2345|-1.4985|||ANCOVA|||Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.|
1756595|NCT00256750|3226414|Superiority or Other||Mean Difference (Final Value)|17.6|||||2-Sided|97.3|12.0|23.3|||||ANOVA model: GFR = treatment|Month 24|
1756427|NCT00257166|3226338|Superiority or Other||LS mean difference|-3.2545|Standard Error of the Mean|0.9422||0.0006|2-Sided|95.0|-5.1045|-1.4046|||ANCOVA|||Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.|
1756428|NCT00257166|3226339|Superiority or Other||Least squares (LS) mean difference|-5.22|Standard Error of the Mean|1.48||0.0005|2-Sided|95.0|-8.12|-2.31|||ANCOVA|||Change at Week 4: Mixed effects repeated measures Analysis of Covariance (ANCOVA) model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.|
1756429|NCT00256997|3226355|Superiority or Other|||||||0.5498||||||P-value was calculated by Cox proportional hazard model stratified for positive and negative symptom scale.|Cox proportional hazard model||||
1756430|NCT00256867|3226368|Superiority or Other||Odds Ratio (OR)|3.93|||<|0.0001|2-Sided|95.0|2.21|7.0|||ANCOVA||Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior SU use) of having an FPG < 7.0 mmol/L or reduction of FPG >= 1.67 mmol/L at Week 16 on All FDC group compared to Simv group.||
1756431|NCT00256867|3226369|Superiority or Other||Odds Ratio (OR)|4.05|||<|0.0001|2-Sided|95.0|2.32|7.07|||ANCOVA||Odds (logistic regression: log odds=Baseline + sex + Treatment + Prior SU use) of having an HbA1c < 7% or reduction of HbA1c >= 0.7% at Week 16 on All FDC group compared to Simv group.||
1756432|NCT00256867|3226370|Superiority or Other||Odds Ratio (OR)|36.32|||<|0.0001||95.0|16.52|79.85|||ANCOVA||Odds (logistic regression:log odds=Baseline + sex + Treatment + Prior Sulfonylurea use) of having an LDL-c < 100 mg/dL at Week 6 on All FDC RSG/SIMV groups compared to All RSG monotherapy groups||
1756433|NCT00256867|3226374|Superiority or Other||Mean Difference (Final Values)|-0.82|||<|0.0001|2-Sided|95.0|-1.09|-0.55|||ANCOVA||Change = Baseline + sex + country + Treatment + Prior Sulfonylurea use||
1756434|NCT00256867|3226375|Superiority or Other||Ratio Expressed as percent difference|-37.186|||<|0.0001|2-Sided|95.0|-41.219|-32.879|||ANCOVA||Estimation parameter was Ratio to RSG Group expressed as percent difference from RSG group. Based on ANCOVA : Log(value) - log(baseline)= log(baseline) + sex + country + Treatment + Prior Sulfonylurea use||
1756435|NCT00256750|3226385|Superiority or Other||Difference in Percent|8.4|||||2-Sided|95.0|0.4|16.4||||||Month 36|
1756436|NCT00256750|3226385|Superiority or Other||Difference in Percent|0.9|||||2-Sided|95.0|-6.6|8.4||||||Month 36|
1756437|NCT00256750|3226385|Superiority or Other||Difference in Percent|9.8|||||2-Sided|95.0|1.9|17.6||||||Month 24|
1756438|NCT00256750|3226385|Superiority or Other||Difference in Percent|1.8|||||2-Sided|95.0|-5.5|9.1||||||Month 24|
1756439|NCT00256750|3226385|Superiority or Other||Difference in Percent|11.5|||||2-Sided|95.0|4.2|18.9||||||Month 12|
1756440|NCT00256750|3226385|Superiority or Other||Difference in Percent|5.9|||||2-Sided|95.0|-1.0|12.8||||||Month 12|
1756441|NCT00256750|3226386|Non-Inferiority or Equivalence|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.5|||||2-Sided|97.3|-2.8|10.0|||||||
1756442|NCT00256750|3226386|Non-Inferiority or Equivalence|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.3|||||2-Sided|97.3|-2.9|9.8||||||Month 36|
1756443|NCT00256750|3226386|Non-Inferiority or Equivalence|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.6|||||2-Sided|97.3|-2.2|9.6||||||Month 24|
1756444|NCT00256750|3226386|Non-Inferiority or Equivalence|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|4.2|||||2-Sided|97.3|-1.3|10.1||||||Month 24|
1756445|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|1.2||||0.1876|2-Sided|95.0|-0.6|2.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36|
1756446|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|1.6||||0.0768|2-Sided|95.0|-0.2|3.3|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36|
1756447|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|1.9||||0.0775|2-Sided|95.0|-0.2|4.0|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36|
1756489|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.7||||0.0992|2-Sided|95.0|-0.3|3.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 24|
1756448|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|2.5||||0.0186|2-Sided|95.0|0.4|4.5|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36|
1756449|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|2.2||||0.0102|2-Sided|95.0|0.5|3.8|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24|
1756450|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|1.4||||0.0971|2-Sided|95.0|-0.3|3.0|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24|
1756451|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|0.8||||0.4633|2-Sided|95.0|-1.3|2.8|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24|
1756452|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|1.4||||0.1849|2-Sided|95.0|-0.6|3.4|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24|
1756453|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|2.2||||0.0077|2-Sided|95.0|0.6|3.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12|
1756454|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|1.6||||0.0526|2-Sided|95.0|0.0|3.2|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12|
1756455|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|0.8||||0.4209|2-Sided|95.0|-1.1|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12|
1756456|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|1.3||||0.1729|2-Sided|95.0|-0.6|3.2|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12|
1756457|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|1.7||||0.0457|2-Sided|95.0|0.0|3.3|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6|
1756458|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|1.1||||0.1595|2-Sided|95.0|-0.5|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6|
1756459|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|1.9||||0.0584|2-Sided|95.0|-0.1|3.9|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6|
1756460|NCT00256750|3226388|Superiority or Other||Mean Difference (Final Value)|0.8||||0.4498|2-Sided|95.0|-1.2|2.7|||ANCOVA|Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6|
1756461|NCT00256750|3226389|Superiority or Other||Mean Difference (Final Value)|-0.021|||<|0.0001|2-Sided|95.0|-0.03|-0.013||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 24|
1756462|NCT00256750|3226389|Superiority or Other||Mean Difference (Final Value)|-0.023|||<|0.0001|2-Sided|95.0|-0.031|-0.015||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 24|
1756463|NCT00256750|3226389|Superiority or Other||Mean Difference (Final Value)|-0.015|||<|0.0001|2-Sided|95.0|-0.024|-0.007||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.|
1756490|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.0||||0.0547|2-Sided|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 24|
1757360|NCT00234078|3228033|Superiority or Other|||||||0.087||||||p-value is adjusted for multiple comparisons|t-test, 2 sided||||
1756464|NCT00256750|3226389|Superiority or Other||Mean Difference (Final Value)|-0.021|||<|0.0001|2-Sided|95.0|-0.03|-0.013||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.|
1756465|NCT00256750|3226389|Superiority or Other||Mean Difference (Final Value)|-0.025|||<|0.0001|2-Sided|95.0|-0.034|-0.016||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 12.|
1756466|NCT00256750|3226389|Superiority or Other||Mean Difference (Final Value)|-0.026|||<|0.0001|2-Sided|95.0|-0.034|-0.017||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 12.|
1756467|NCT00256750|3226389|Superiority or Other||Mean Difference (Final Value)|-0.02|||<|0.0001|2-Sided|95.0|-0.029|-0.012||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.|
1756468|NCT00256750|3226389|Superiority or Other||Mean Difference (Final Value)|-0.024|||<|0.0001|2-Sided|95.0|-0.032|-0.016||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.|
1756469|NCT00256750|3226389|Superiority or Other||Mean Difference (Final Value)|-0.026|||<|0.0001|2-Sided|95.0|-0.035|-0.017||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 6.|
1756470|NCT00256750|3226389|Superiority or Other||Mean Difference (Final Value)|-0.023|||<|0.0001|2-Sided|95.0|-0.031|-0.014||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Occurrence, Month 6.|
1756471|NCT00256750|3226389|Superiority or Other||Mean Difference (Final Value)|-0.019|||<|0.0001|2-Sided|95.0|-0.028|-0.011||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.|
1756472|NCT00256750|3226389|Superiority or Other||Mean Difference (Final Value)|-0.024|||<|0.0001|2-Sided|95.0|-0.032|-0.015||Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.|z-test|The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.||Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.|
1756473|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.1||||0.0525|2-Sided|95.0|0.0|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 36|
1756474|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.2||||0.0361|2-Sided|95.0|0.1|4.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 36|
1756475|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.5||||0.6331|2-Sided|95.0|-1.5|2.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 36|
1756476|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.5||||0.1369|2-Sided|95.0|-0.5|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 36|
1756477|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.6||||0.0128|2-Sided|95.0|0.6|4.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 36|
1756478|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.7||||0.0087|2-Sided|95.0|0.7|4.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 36|
1756479|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.9||||0.1141|2-Sided|95.0|-0.4|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 36|
1756480|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.5||||0.0299|2-Sided|95.0|0.2|4.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 36|
1756481|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.0||||0.3303|2-Sided|95.0|-1.0|2.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 36|
1756482|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.3||||0.1836|2-Sided|95.0|-0.6|3.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 36|
1756483|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.3||||0.2484|2-Sided|95.0|-0.9|3.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 36|
1756484|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.5||||0.171|2-Sided|95.0|-0.7|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 36|
1756485|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.0||||0.045|2-Sided|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 36|
1756486|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.3||||0.0211|2-Sided|95.0|0.3|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 36|
1756487|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.0||||0.3572|2-Sided|95.0|-1.1|3.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 36|
1756492|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.3||||0.1914|2-Sided|95.0|-0.7|3.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 24|
1756493|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|3.9||||0.0002|2-Sided|95.0|1.9|5.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 24|
1756494|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.5||||0.0164|2-Sided|95.0|0.5|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 24|
1756495|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.3||||0.2663|2-Sided|95.0|-1.0|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 24|
1756496|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.7||||0.1352|2-Sided|95.0|-0.5|3.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 24|
1756497|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.5||||0.1285|2-Sided|95.0|-0.4|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 24|
1756498|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.2||||0.0276|2-Sided|95.0|0.2|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 24|
1756499|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.8||||0.4804|2-Sided|95.0|-1.4|2.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 24|
1756500|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.2||||0.2555|2-Sided|95.0|-0.9|3.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 24|
1756501|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.5||||0.00886|2-Sided|95.0|0.6|4.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 24|
1756502|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.2||||0.0214|2-Sided|95.0|0.3|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 24|
1756503|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.5||||0.1608|2-Sided|95.0|-0.6|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 24|
1756504|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.4||||0.699|2-Sided|95.0|-1.6|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 24|
1756505|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.6||||0.0075|2-Sided|95.0|0.7|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 12|
1756506|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.3||||0.016|2-Sided|95.0|0.4|4.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 12|
1756507|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.5||||0.1263|2-Sided|95.0|-0.4|3.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 12|
1756508|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.8||||0.3978|2-Sided|95.0|-1.1|2.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 12|
1756509|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.5||||0.0151|2-Sided|95.0|0.5|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 12|
1756510|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.1||||0.0392|2-Sided|95.0|0.1|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 12|
1756511|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.0||||0.9672|2-Sided|95.0|-2.2|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 12|
1756512|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.0||||0.386|2-Sided|95.0|-1.2|3.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 12|
1756513|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.9||||0.3291|2-Sided|95.0|-0.9|2.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 12|
1756514|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.8||||0.0503|2-Sided|95.0|0.0|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 12|
1756515|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.5||||0.6319|2-Sided|95.0|-1.6|2.6|||ANOVA|Missing data were imputed by LOCF|Missing data were imputed by LOCF|Mental Health, Month 12|
1756516|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.0||||0.363|2-Sided|95.0|-1.1|3.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 12|
1756517|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.3||||0.0174|2-Sided|95.0|0.4|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 12|
1756518|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.9||||0.0423|2-Sided|95.0|0.1|3.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 12|
1756519|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.9||||0.0042|2-Sided|95.0|0.9|4.9|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 12|
1756520|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.9||||0.0571|2-Sided|95.0|-0.1|3.8|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 12|
1756521|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.2||||0.0289|2-Sided|95.0|0.2|4.1|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 6|
1756522|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.5||||0.1222|2-Sided|95.0|-0.4|3.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Vitality, Month 6|
1756523|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.4||||0.7006|2-Sided|95.0|-1.7|2.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 6|
1756524|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.3||||0.7637|2-Sided|95.0|-1.8|2.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Social Functioning, Month 6|
1756525|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|3.6||||0.0007|2-Sided|95.0|1.5|5.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role-Physical, Month 6|
1756526|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.0||||0.0502|2-Sided|95.0|0.0|4.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Physical, Month 6|
1756527|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.2||||0.0588|2-Sided|95.0|-0.1|4.5|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 6|
1756528|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.3||||0.237|2-Sided|95.0|-0.9|3.6|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Role Emotional, Month 6|
1756529|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.6||||0.5437|2-Sided|95.0|-1.2|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 6|
1756530|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.9||||0.3018|2-Sided|95.0|-0.8|2.7|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Physical Functioning, Month 6|
1756531|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.3||||0.2523|2-Sided|95.0|-0.9|3.4|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 6|
1756532|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.2||||0.8332|2-Sided|95.0|-1.9|2.3|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|Mental Health, Month 6|
1756533|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.1||||0.2499|2-Sided|95.0|-0.8|3.0|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 6|
1756534|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|0.3||||0.7543|2-Sided|95.0|-1.6|2.2|||ANOVA|Missing data = treatment|Missing data were imputed by LOCF|General Health, Month 6|
1756535|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|2.0||||0.0536|2-Sided|95.0|0.0|4.1|||ANOVA|Domain score = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 6|
1756536|NCT00256750|3226390|Superiority or Other||Mean Difference (Final Value)|1.9||||0.0714|2-Sided|95.0|-0.2|3.9|||ANOVA|Domain Score = treatment|Missing data were imputed by LOCF|Bodily Pain, Month 6|
1756537|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|1.7||||0.0684|2-Sided|95.0|-0.1|3.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36|
1756538|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|2.1||||0.0191|2-Sided|95.0|0.3|3.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 36|
1756539|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|1.5||||0.1961|2-Sided|95.0|-0.8|3.7||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36|
1756540|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|1.9||||0.0953|2-Sided|95.0|-0.3|4.1||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 36|
1756541|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|2.7||||0.0026|2-Sided|95.0|0.9|4.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24|
1756542|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|1.8||||0.0417|2-Sided|95.0|0.1|3.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 24|
1756543|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|0.5||||0.6635|2-Sided|95.0|-1.7|2.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24|
1756544|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|1.3||||0.234|2-Sided|95.0|-0.8|3.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 24|
1756596|NCT00256750|3226414|Superiority or Other||Mean Difference (Final Value)|17.5|||||2-Sided|97.3|12.0|23.1|||||ANOVA model: GFR = treatment|Month 24|
1756597|NCT00256750|3226414|Superiority or Other||Mean Difference (Final Value)|15.1|||||2-Sided|97.3|10.1|20.1|||||ANOVA model: GFR = treatment|Month 12|
1756545|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|2.8||||0.0015|2-Sided|95.0|1.1|4.5||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12|
1756546|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|2.1||||0.0144|2-Sided|95.0|0.4|3.8||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 12|
1756547|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|0.4||||0.7327|2-Sided|95.0|-1.7|2.4||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12|
1756548|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|0.8||||0.4146|2-Sided|95.0|-1.2|2.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 12|
1756549|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|1.9||||0.0257|2-Sided|95.0|0.2|3.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6|
1756550|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|1.5||||0.0672|2-Sided|95.0|-0.1|3.2||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Physical Component Score; Month 6|
1756551|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|1.7||||0.1198|2-Sided|95.0|-0.4|3.9||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6|
1756552|NCT00256750|3226391|Superiority or Other||Mean Difference (Final Value)|0.5||||0.6573|2-Sided|95.0|-1.6|2.6||Baseline observations were not used for imputations at subsequent time points.|ANOVA|ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.|Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.|Mental Component Score; Month 6|
1756553|NCT00256750|3226393|Superiority or Other||Difference in Percent|-0.9|||||2-Sided|97.3|-6.9|4.8|||||||
1756554|NCT00256750|3226393|Superiority or Other||Difference in Percent|-0.5|||||2-Sided|97.3|-6.5|5.3||||||Month 12|
1756555|NCT00256750|3226397|Superiority or Other||Difference in Percent|-3.2|||||2-Sided|95.0|-6.6|-0.6|||||For 95% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.||
1756556|NCT00256750|3226397|Superiority or Other||Difference in Percent|-3.2|||||2-Sided|95.0|-6.6|-0.6|||||For 95% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.||
1756557|NCT00256750|3226399|Non-Inferiority or Equivalence|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|14.7|||||2-Sided|97.3|7.0|22.6|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.|Month 36|
1756558|NCT00256750|3226399|Non-Inferiority or Equivalence|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|7.8|||||2-Sided|97.3|0.6|15.0|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.|Month 36|
1756559|NCT00256750|3226399|Non-Inferiority or Equivalence|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|15.2|||||2-Sided|97.3|7.5|23.0|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.|Month 24|
1756560|NCT00256750|3226399|Non-Inferiority or Equivalence|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.|Difference in Percent|8.2|||||2-Sided|97.3|1.2|15.4|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used|Month 24|
1756598|NCT00256750|3226414|Superiority or Other||Mean Difference (Final Value)|15.3|||||2-Sided|97.3|10.3|20.3|||||ANOVA model: GFR = treatment|Month 12|
1756561|NCT00256750|3226399|Non-Inferiority or Equivalence|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|16.5|||||2-Sided|97.3|9.6|23.8|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.|Month 6|
1756562|NCT00256750|3226399|Non-Inferiority or Equivalence|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|11.4|||||2-Sided|97.3|5.0|18.2|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.|Month 6|
1756563|NCT00256750|3226401|Superiority or Other||Difference in Percent|-8.7|||||2-Sided|97.3|-19.9|2.7|||||||
1756564|NCT00256750|3226401|Superiority or Other||Difference in Percent|-10.4|||||2-Sided|97.3|-21.4|1.0|||||||
1756565|NCT00256750|3226406|Superiority or Other||Difference in Percent|3.77|||||2-Sided|97.3|-5.86|13.35|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine||
1756566|NCT00256750|3226406|Superiority or Other||Difference in Percent|7.01|||||2-Sided|97.3|-2.79|16.71|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine||
1756567|NCT00256750|3226407|Superiority or Other||Difference in Percent|3.2|||||2-Sided|97.3|-6.6|12.9|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|At Month 12|
1756568|NCT00256750|3226407|Superiority or Other||Difference in Percent|7.1|||||2-Sided|97.3|-2.9|17.1|||||A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|At Month 12|
1756569|NCT00256750|3226408|Superiority or Other||Mean Difference (Final Value)|-3.4|||||2-Sided|97.3|-6.0|-0.9||||||Diastolic, Month 36|
1756570|NCT00256750|3226408|Superiority or Other||Mean Difference (Final Value)|-2.9|||||2-Sided|97.3|-5.4|-0.4||||||Diastolic, Month 36|
1756571|NCT00256750|3226408|Superiority or Other||Mean Difference (Final Value)|-7.5|||||2-Sided|97.3|-11.7|-3.3||||||Systolic, Month 36|
1756572|NCT00256750|3226408|Superiority or Other||Mean Difference (Final Value)|-5.8|||||2-Sided|97.3|-10.0|-1.6||||||Systolic, Month 36|
1756573|NCT00256750|3226408|Superiority or Other||Mean Difference (Final Value)|-2.4|||||2-Sided|97.3|-5.0|0.1||||||Diastolic, Month 24|
1756574|NCT00256750|3226408|Superiority or Other||Mean Difference (Final Value)|-1.9|||||2-Sided|97.3|-4.4|0.5||||||Diastolic, Month 24|
1756575|NCT00256750|3226408|Superiority or Other||Mean Difference (Final Value)|-5.5|||||2-Sided|97.3|-9.9|-1.1||||||Systolic, Month 24|
1756576|NCT00256750|3226408|Superiority or Other||Mean Difference (Final Value)|-4.9|||||2-Sided|97.3|-9.2|-0.6||||||Systolic, Month 24|
1756577|NCT00256750|3226408|Superiority or Other||Mean Difference (Final Value)|-2.6|||||2-Sided|97.3|-5.1|0.0||||||Diastolic, Month 12|
1756578|NCT00256750|3226408|Superiority or Other||Mean Difference (Final Value)|-3.2|||||2-Sided|97.3|-5.8|-0.7||||||Diastolic, Month 12|
1756579|NCT00256750|3226408|Superiority or Other||Mean Difference (Final Value)|-6.0|||||2-Sided|97.3|-10.1|-2.0||||||Systolic, Month 12|
1756580|NCT00256750|3226408|Superiority or Other||Mean Difference (Final Value)|-7.3|||||2-Sided|97.3|-11.4|-3.3||||||Systolic, Month 12|
1756581|NCT00256750|3226409|Superiority or Other||Difference in Percent|-2.37|||||2-Sided|97.3|-9.01|4.15|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.|Month 12|
1756582|NCT00256750|3226409|Superiority or Other||Difference in Percent|-1.13|||||2-Sided|97.3|-7.51|5.23|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.|Month 12|
1756583|NCT00256750|3226410|Superiority or Other||Difference in Percent|-17.9|||||2-Sided|97.3|-72.3|52.2|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.|Month 12|
1756584|NCT00256750|3226410|Superiority or Other||Difference in Percent|-21.2|||||2-Sided|97.3|-67.6|43.2|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.|Month 12|
1756585|NCT00256750|3226411|Superiority or Other||Odds Ratio, log|0.6||||0.0092|2-Sided|97.3|0.38|0.92|||Chi-squared||Odds ratio is estimated by a cumulative logit model.||
1756586|NCT00256750|3226411|Superiority or Other||Odds Ratio (OR)|0.5||||0.0002|2-Sided|97.3|0.31|0.74|||Chi-squared||Odds ratio is estimated by a cumulative logit model.||
1756587|NCT00256750|3226412|Superiority or Other||Difference in Percent|-0.9||||0.9481|2-Sided|97.3|-8.8|7.1||Normal approximation is used if N>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 36|
1756588|NCT00256750|3226412|Superiority or Other||Difference in Percent|-4.6||||0.2043|2-Sided|97.3|-12.0|2.5|||Chi-squared|Normal approximation is used if N>=5 in both arms. Otherwise, exact method is used.||Month 36|
1756589|NCT00256750|3226412|Superiority or Other||Difference in Percent|-2.2||||0.6405|2-Sided|97.3|-9.8|5.4||Normal approximation is used if N>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 24|
1756590|NCT00256750|3226412|Superiority or Other||Difference in Percent|-5.1||||0.1267|2-Sided|97.3|-12.3|1.5||Normal approximation is used if N>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 24|
1756591|NCT00256750|3226412|Superiority or Other||Difference in Percent|-2.8||||0.4825|2-Sided|97.3|-10.2|4.4||Normal approximation is used if N>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 12|
1756592|NCT00256750|3226412|Superiority or Other||Difference in Percent|-5.7||||0.0687|2-Sided|97.3|-12.6|0.5||Normal approximation is used if N>=5 in both arms. Otherwise, exact method is used.|Chi-squared|||Month 12|
1756593|NCT00256750|3226414|Superiority or Other||Mean Difference (Final Value)|20.8|||||2-Sided|97.3|14.8|26.9|||||ANOVA model: GFR = treatment|Month 36|
1756594|NCT00256750|3226414|Superiority or Other||Mean Difference (Final Value)|21.4|||||2-Sided|97.3|15.4|27.4|||||ANOVA model: GFR = treatment|Month 36|
1756599|NCT00256750|3226418|Superiority or Other||Difference in Percent|-10.3|||||2-Sided|97.3|-16.1|-5.1|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.|Percent treatment difference measured as Belatacept - LI minus Cyclosporine|
1756600|NCT00256750|3226418|Superiority or Other||Difference in Percent|-8.5|||||2-Sided|97.3|-14.6|-3.3|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.|Percent treatment difference measured as Belatacept - LI minus Cyclosporine|
1756601|NCT00256750|3226423|Non-Inferiority or Equivalence|Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.|Difference in Percent|-14.2||||0.001|2-Sided|97.3|-23.2|-5.0|||Chi-squared, Corrected|A continuity corrected chi-square test at a significance level of 0.027 was performed.|||
1756602|NCT00256750|3226423|Non-Inferiority or Equivalence|Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.|Difference in Percent|-8.5||||0.0581|2-Sided|97.3|-17.9|0.9|||Chi-squared, Corrected|A continuity corrected chi-square test at a significance level of 0.027 was performed.|||
1756603|NCT00256750|3226424|Superiority or Other||Mean Difference (Final Values)|14.5|||<|0.0001|2-Sided|97.3|8.5|20.5||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 24|
1756604|NCT00256750|3226424|Superiority or Other||Mean Difference (Final Values)|17.4|||<|0.0001|2-Sided|97.3|11.5|23.4||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 24|
1756605|NCT00256750|3226424|Superiority or Other||Mean Difference (Final Values)|14.6|||<|0.0001|2-Sided|97.3|8.9|20.4||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 12|
1756606|NCT00256750|3226424|Superiority or Other||Mean Difference (Final Values)|13.0|||<|0.0001|2-Sided|97.3|7.3|18.7||To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.|Kruskal-Wallis|Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)|Test were conducted at a level of 0.027 (2-sided).|Time Frame = Day 1 to Month 12|
1756607|NCT00256750|3226425|Non-Inferiority or Equivalence|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens. The 20% non-inferiority margin was not met in the belatacept MI group.|Difference in Percent|14.7|||||2-Sided|97.3|7.5|22.2|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.||
1756608|NCT00256750|3226425|Non-Inferiority or Equivalence|A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens|Difference in Percent|10.0|||||2-Sided|97.3|3.3|17.1|||||For 97.3% CI of difference, normal approximation is used if N>=5 in both arms. Otherwise exact method is used.||
1756609|NCT00256750|3226426|Superiority or Other||Difference in Percent|-22.9|||<|0.0001|2-Sided|97.3|-32.6|-12.9|||Chi-squared, Corrected|A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|||
1756610|NCT00256750|3226426|Superiority or Other||Difference in Percent|-23.7|||<|0.0001|2-Sided|97.3|-33.3|-13.7|||Chi-squared, Corrected|A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine|||
1756611|NCT00256750|3226427|Non-Inferiority or Equivalence|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on ‘preservation of benefit’ is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|2.7|||||2-Sided|97.3|-2.5|8.1|||||If the lower bound of the CI (belatacept-CsA) was > -10%, then the corresponding belatacept regimen was considered non-inferior to CsA.||
1756612|NCT00256750|3226427|Non-Inferiority or Equivalence|A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab.|Difference in Percent|3.7|||||2-Sided|97.3|-1.1|9.0|||||||
1756613|NCT00256204|3226454|Superiority or Other||Mean Difference (Final Values)|-3.154|||<|0.0001||95.0|-4.004|-2.305|||ANCOVA|||"The adjusted means of the changes in Total UPDRS from baseline to LOV in the placebo-controlled phase, observed in the 1 mg and 2 mg rasagiline early-start groups are compared (two contrasts) to the combined placebo group (1 mg and 2 mg rasagiline delayed-start groups), by applying an Analysis of Covariance model. The model includes treatment group, center and baseline Total UPDRS as covariates.~For this analysis, both delayed start arms are pooled as a 'placebo arm'"|
1756614|NCT00256204|3226454|Superiority or Other||Mean Difference (Final Values)|-3.005|||<|0.0001||95.0|-3.857|-2.153|||ANCOVA|||The adjusted means of the changes in Total UPDRS from baseline to LOV in the placebo-controlled phase, observed in the 1 mg and 2 mg rasagiline early-start groups are compared (two contrasts) to the combined placebo group (1 mg and 2 mg rasagiline delayed-start groups), by applying an Analysis of Covariance model. The model includes treatment group, center and baseline Total UPDRS as covariates. For this analysis, both delayed start arms are pooled as a 'placebo arm'|
1756615|NCT00256204|3226455|Non-Inferiority or Equivalence|Non-Inf Test for difference in slopes between treatment groups. One sided 95% CI calculated for difference between slopes of the 2mg early-start group and the 2mg delayed-start group. The inferiority null hypothesis of the early-start group slope over delayed-start group slope is rejected, if the upper limit of one sided 95% CI for difference in slopes does not cross non-inferiority margin of 0.15 UPDRS points per week.|Slope|0.029||||||90.0|-0.005|0.062||||||"Hypothesis #3: Slopes Non-Inferiority of Early Start over Delayed Start in the Active Phase.~Where slope is the model estimate of the change from baseline in total UPDRS per week. In this analysis, observations of all subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set)."|
1756616|NCT00256204|3226455|Non-Inferiority or Equivalence|Non-Inf Test for difference in slopes between treatment groups. One sided 95% CI calculated for difference between slopes of the 1mg early-start group and the 1mg delayed-start group. The inferiority null hypothesis of the early-start group slope over delayed-start group slope is rejected, if the upper limit of one sided 95% CI for difference in slopes does not cross non-inferiority margin of 0.15 UPDRS points per week.|Slope|0.0||||||90.0|-0.036|0.036||||||"Hypothesis #3: Slopes Non-Inferiority of Early Start over Delayed Start in the Active Phase.~Where slope is the model estimate of the change from baseline in total UPDRS per week. In this analysis, observations of all subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set)."|
1756617|NCT00256204|3226455|Superiority or Other|||||||0.6028||||||The analysis was performed on separate datasets and not on the combined dataset as was pre-specified to account for unexpected interactions of dose level by baseline UPDRS and of dose level by center|Repeated Measures|||Hypothesis #2:Superiority of Early over Delayed Start at Week 72 In this analysis, observations of subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active-treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set.)|
1756618|NCT00256204|3226455|Superiority or Other|||||||0.025||||||The analysis was performed on separate datasets and not on the combined dataset as was pre-specified to account for unexpected interactions of dose level by baseline UPDRS and of dose level by center .|Repeated Measures|||Hypothesis #2: Superiority of Early over Delayed Start at Week 72 In this analysis, observations of subjects entering the active phase with at least 24 weeks of treatment during the PC Phase and at least one available Total UPDRS measurement during the active-treatment phase from weeks 48, 54, 60, 66 or 72, are analyzed (ACTE data analysis set).|
1756619|NCT00256204|3226455|Superiority or Other|||||||0.0001|||||||Repeated Measures Mixed Linear Model|||"Hypothesis #1: Slopes Superiority of 2mg Rasagiline over Placebo in the PC Phase Where slope is the model estimate of the change from baseline in total UPDRS per week.~In this analysis, all available post-baseline observations in the PC Phase of the trial are analyzed (ITT efficacy data analysis set, weeks 12, 24 and 36). The placebo groups for rasagiline 1mg (delayed-start)and 2mg (delayed-start) are combined to one placebo group."|
1756620|NCT00256204|3226455|Superiority or Other|||||||0.0133|||||||Repeated Measures Mixed Linear Model|||"Hypothesis #1: Slopes Superiority of 1mg Rasagiline over Placebo in the PC Phase Where slope is the model estimate of the change from baseline in total UPDRS per week.~In this analysis, all available post-baseline observations in the PC Phase of the trial are analyzed (ITT efficacy data analysis set, weeks 12, 24 and 36). The placebo groups for rasagiline 1mg (delayed-start) and 2mg (delayed-start)are combined to one placebo group."|
1756621|NCT00256126|3226461|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1756622|NCT00255970|3226464|Superiority or Other||||||>|0.05|||||||ANOVA|||This study had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).|
1756623|NCT00255970|3226465|Superiority or Other||||||>|0.05|||||||ANOVA|||Each gingival unit (buccal, lingual, mesiobuccal, distobuccal, mesiolingual, and distolingual) of the individual tooth will be given a score from 0-3, called the gingival index for the area. The scores from the 6 areas of the tooth are added and divided by 6 to give the gingival index for the tooth.|
1756624|NCT00255970|3226466|Superiority or Other||||||>|0.05|||||||ANOVA|||The change in recession, measured in mm, had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).|
1756625|NCT00255970|3226467|Superiority or Other||||||>|0.05|||||||ANOVA|||This study had been designed as a superiority study. The a priori power analysis had been designed with an effect size based on historical data. Thus, a minimal sample size of 34 patients would be necessary to determine if there was a true difference between groups, α =.05, power= 0.8. This number was then rounded to 40 patients, 20/ group (DFDBA and Regenafil).|
1756626|NCT00255970|3226468|Superiority or Other||||||>|0.05||||||The power analysis had been computed for a threshold of 0.05 with a power of 0.8.|ANOVA|||A power analysis, prior to data collection, determined that a minimum of 18 in each arm would be needed for this study.|
1756627|NCT00255970|3226468|Superiority or Other||||||>|0.05|||||||ANOVA|||This study had been designed as a superiority study. The null hypothesis had been that there would be no significant difference in probing depth between groups at the time points measured.|
1756682|NCT00255008|3226534|Superiority or Other||Proportion of patients (%)|80.0||||||95.0|28.36|99.49|||||||
1756768|NCT00251719|3226751|Superiority or Other|||||||0.174||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank||||
1756628|NCT00255190|3226483|Superiority or Other|||||||0.469||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.|||
1756629|NCT00255190|3226484|Superiority or Other|||||||0.005||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.|||
1756630|NCT00255190|3226485|Superiority or Other|||||||0.243||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.|||
1756631|NCT00255190|3226486|Superiority or Other|||||||0.03||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.|||
1756632|NCT00255190|3226487|Superiority or Other|||||||0.176||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.|||
1756633|NCT00255190|3226488|Superiority or Other|||||||0.656||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.|||
1756634|NCT00255190|3226489|Superiority or Other|||||||0.102||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.|||
1756635|NCT00255190|3226490|Superiority or Other|||||||0.286||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.|||
1756636|NCT00255190|3226491|Superiority or Other|||||||0.207||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756637|NCT00255190|3226492|Superiority or Other|||||||0.011||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756638|NCT00255190|3226493|Superiority or Other|||||||0.319||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756639|NCT00255190|3226494|Superiority or Other|||||||0.065||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756640|NCT00255190|3226495|Superiority or Other|||||||0.601||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756641|NCT00255190|3226496|Superiority or Other|||||||0.817||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756642|NCT00255190|3226497|Superiority or Other|||||||0.673||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756643|NCT00255190|3226498|Superiority or Other|||||||0.737||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756644|NCT00255190|3226499|Superiority or Other|||||||0.758||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756645|NCT00255190|3226500|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756646|NCT00255190|3226501|Superiority or Other|||||||0.923||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756647|NCT00255190|3226502|Superiority or Other|||||||0.843||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756648|NCT00255190|3226503|Superiority or Other|||||||0.22||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756649|NCT00255190|3226504|Superiority or Other|||||||0.026||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756650|NCT00255190|3226505|Superiority or Other|||||||0.494||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756651|NCT00255190|3226506|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756652|NCT00255190|3226507|Superiority or Other|||||||0.109||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using an ANCOVA model with treatment as the factor and baseline score as the covariate.|||
1756653|NCT00255190|3226508|Superiority or Other|||||||0.204||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANCOVA|Comparisons were made using a one-way analysis of covariance (ANCOVA) model with treatment as the factor and baseline score as the covariate.|||
1756654|NCT00255190|3226509|Superiority or Other|||||||0.006||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756655|NCT00255190|3226510|Superiority or Other|||||||0.042||||||Statistical significance was determined at 0.05 level. All statistical tests were two-sided and the p-values were rounded to 3 decimal places prior to determining statistical significance.|ANOVA||||
1756656|NCT00255164|3226513|Superiority or Other|||||||0.597||||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1756657|NCT00255164|3226513|Superiority or Other||||||<|1e-05||||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dose to placebo.|Wilcoxon (Mann-Whitney)||||
1756658|NCT00255164|3226513|Superiority or Other||||||<|1e-05||||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dose to placebo.|Wilcoxon (Mann-Whitney)||||
1756659|NCT00255164|3226514|Superiority or Other|||||||0.37161||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Log Rank||||
1756660|NCT00255164|3226514|Superiority or Other||||||<|1e-05||||||Hochberg’s method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank||||
1756661|NCT00255164|3226514|Superiority or Other||||||<|1e-05||||||Hochberg’s method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank||||
1756662|NCT00255164|3226516|Superiority or Other|||||||0.76046||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1756663|NCT00255164|3226516|Superiority or Other||||||<|1e-05||||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)||||
1756664|NCT00255164|3226516|Superiority or Other||||||<|1e-05||||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)||||
1756665|NCT00255164|3226517|Superiority or Other|||||||0.80473||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Fisher Exact||||
1756666|NCT00255164|3226517|Superiority or Other||||||<|1e-05||||||Hochberg’s method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact||||
1756667|NCT00255164|3226517|Superiority or Other||||||<|1e-05||||||Hochberg’s method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact||||
1756668|NCT00255151|3226519|Superiority or Other|||||||0.597||||||Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1756669|NCT00255151|3226519|Superiority or Other||||||<|1e-05||||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)||||
1756670|NCT00255151|3226519|Superiority or Other||||||<|1e-05||||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)||||
1756671|NCT00255151|3226520|Superiority or Other|||||||0.37161||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Log Rank||||
1756672|NCT00255151|3226520|Superiority or Other||||||<|1e-05||||||Hochberg’s method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank||||
1756673|NCT00255151|3226520|Superiority or Other||||||<|1e-05||||||Hochberg’s method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Log Rank||||
1756674|NCT00255151|3226522|Superiority or Other|||||||0.76046||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1756675|NCT00255151|3226522|Superiority or Other||||||<|1e-05||||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)||||
1756676|NCT00255151|3226522|Superiority or Other||||||<|1e-05||||||The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.|Wilcoxon (Mann-Whitney)||||
1756677|NCT00255151|3226523|Superiority or Other|||||||0.80473||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Fisher Exact||||
1756678|NCT00255151|3226523|Superiority or Other||||||<|1e-05||||||Hochberg’s method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact||||
1756679|NCT00255151|3226523|Superiority or Other||||||<|1e-05||||||Hochberg’s method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.|Fisher Exact||||
1756680|NCT00255008|3226534|Superiority or Other||Proportion of patients (%)|87.5||||||95.0|47.35|99.48|||||||
1756681|NCT00255008|3226534|Superiority or Other||Proportion of patients (%)|76.47||||||95.0|50.1|93.19|||||||
1756683|NCT00254566|3226546|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.8||95.0|-0.18|0.14|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate|||
1756684|NCT00254566|3226546|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.62||95.0|-0.26|0.16|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates|||
1756685|NCT00254566|3226547|Superiority or Other||Mean Difference (Final Values)|-0.04||||0.56||95.0|-0.17|0.09|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate|||
1756686|NCT00254566|3226547|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.385||95.0|-0.27|0.1|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates|||
1756687|NCT00254566|3226548|Superiority or Other||Mean Difference (Final Values)|0.01||||0.87||95.0|-0.12|0.14|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate|||
1756688|NCT00254566|3226548|Superiority or Other||Mean Difference (Final Values)|-0.02||||0.81||95.0|-0.21|0.17|||ANCOVA|Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates|||
1756689|NCT00254566|3226549|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.82||95.0|-0.13|0.1|||Mixed Models Analysis|Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate|||
1756690|NCT00254566|3226549|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.57||95.0|-0.21|0.12|||ANCOVA|Estimated from ANCOVA with treatment, steriod use, and country fitted as factor and baseline CCQ total scores and FEV1 fitted as covariates|||
1756691|NCT00254566|3226550|Superiority or Other||Cox Proportional Hazard|1.33||||0.159||95.0|0.9|2.0||p-value was estimated from Cox's Proportional Hazard model with steriod use and country as factors and baseline FEV1 fitted as covariate|Regression, Cox|||Kaplan-Meier method was used to estimate time taken for 1st 25th quartile of subjects to experience recurrence of AECB. Estimate of median time to event couldn't be calculated because <50% of subjects in analysis population experienced a recurrence. The ratio of the treatment groups’ recurrence rate (hazard ratio) estimated using Cox proportional hazards model adjusting for steroid use, frequency of AECB in previous 12 months, country and baseline Forced expiratory volume in 1 second (FEV1).|
1756692|NCT00254566|3226551|Superiority or Other||Risk Difference (RD)|-0.6||||||95.0|-4.5|3.3|||||Risk difference is the difference in eradication rates of pathogens by treatment||
1756693|NCT00254566|3226552|Non-Inferiority or Equivalence|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-2.5||||||95.0|-8.5|3.4|||||Risk difference is the difference in percentage of participants with cure and the 95% Confidence|95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciprocal of the variance. Stratification will be by steroid use at time of randomization.|
1756694|NCT00254566|3226553|Non-Inferiority or Equivalence|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-2.5||||||95.0|-8.5|3.4|||||Risk difference is the difference in the percentage of participants with Cure and the 95% CI|95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.|
1756695|NCT00254566|3226554|Non-Inferiority or Equivalence|Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%|Risk Difference (RD)|-0.9||||||95.0|-5.8|3.9|||||Risk difference is the difference in percentage of participants with cure and the 95% Confidence Interval|95% Confidence Interval (CI) for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.|
1756696|NCT00254540|3226570|Superiority or Other||Objective Response Rate(percentage)|46.2||||||95.0|26.6|66.6|||||||
1756697|NCT00254540|3226570|Superiority or Other||Objective Response Rate(percentage)|48.0||||||95.0|27.8|68.7|||||||
1756698|NCT00254501|3226571|Superiority or Other|||||||0.0024|||||||ANCOVA|||Comparison of change in Understanding of Diabetes from baseline to 12 months between groups.|
1756699|NCT00254501|3226571|Superiority or Other|||||||0.302|||||||ANCOVA|||Comparison of change in Adherence Starts with Knowledge (ASK-20) from baseline to 12 months between groups.|
1756700|NCT00254501|3226571|Superiority or Other|||||||0.785|||||||ANCOVA|||Comparison of change in Diabetes Empowerment Scale from baseline to 12 months between groups.|
1756701|NCT00254501|3226572|Superiority or Other|||||||0.4303|||||||Wilcoxon (Mann-Whitney)|||Analyses not adjusted for other variables.|
1756702|NCT00254501|3226572|Superiority or Other|||||||0.6413|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in cost of diabetes medications from baseline to 12 months between groups. Analyses not adjusted for other variables.|
1756703|NCT00254501|3226572|Superiority or Other|||||||0.3856|||||||Wilcoxon (Mann-Whitney)|||Comparison of change in cost of total health care from baseline to 12 months between groups. Analyses not adjusted for other variables.|
1756704|NCT00254501|3226573|Superiority or Other|||||||0.92|||||||ANCOVA|||Comparison of change in triglycerides from baseline to 12 months between groups.|
1756705|NCT00254501|3226573|Superiority or Other|||||||0.14|||||||ANCOVA|||Comparison of change in total cholesterol from baseline to 12 months between groups.|
1756706|NCT00254501|3226573|Superiority or Other|||||||0.16|||||||ANCOVA|||Comparison of change in HDL from baseline to 12 months between groups.|
1756707|NCT00254501|3226573|Superiority or Other|||||||0.44|||||||ANCOVA|||Comparison of change in LDL from baseline to 12 months between groups.|
1756708|NCT00254501|3226574|Superiority or Other|||||||0.0757||||||Adjusted for baseline Hemoglobin A-1C.|ANCOVA|||"Null hypothesis is mean change in usual care group equals mean change in Empower group.~Power calculation required 150 per group assuming 25% would withdraw prior to 12 months."|
1756709|NCT00253890|3226614|Superiority or Other||Mean Difference (Net)|35.7||||0.05||95.0|||||t-test, 2 sided|||Change in sleep quality was assessed by calculating gain scores. We used a 2-sided t-test to report mean change.|
1756710|NCT00253643|3226625|Superiority or Other|||||||0.1573||||||A priori threshold for statistical significance is 0.05.|Mixed Models Analysis|||Mixed effects model to assess the effect of time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on Ki-67|
1756711|NCT00253643|3226626|Superiority or Other|||||||0.1521||||||Utilized a priori threshold for statistical significance of 0.05.|Mixed Models Analysis|||Mixed effects model to assess the effect time (pre vs. post) and treatment (GTFO, GT, FO and Placebo) on FAS summary scores|
1756712|NCT00253370|3226644|Superiority or Other||proportion of participants|0.409||||0.0012|2-Sided|90.0|0.284|0.544|||one-sample binomial test|||The study was designed to distinguish a response rate of 40% from 20%, the null hypothesis. With the planned sample size of 36 eligible patients, the study has 91% power based on a 0.09 level one-sided test.|
1756713|NCT00252733|3226656|Superiority or Other||Hazard Ratio (HR)|0.821||||0.0508|2-Sided|95.0|0.673|1.001|||Log Rank|Generalized|||
1756714|NCT00252720|3226660|Superiority or Other||Hazard Ratio (HR)|1.024||||0.8487|2-Sided|95.0|0.8|1.312|||Log Rank|Generalized|||
1756715|NCT00252694|3226664|Superiority or Other||Hazard Ratio (HR)|0.87||||0.1994|2-Sided|95.0|0.704|1.076|||Log Rank|Generalized|||
1756716|NCT00252629|3226665|Superiority or Other|||||||0.0001|||||||t-test, 2 sided|||The p value was based on t-test|
1756717|NCT00252629|3226666|Superiority or Other|||||||0.004|||||||t-test, 2 sided|||The change of cognitive dysfunction complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.|
1756718|NCT00252629|3226667|Superiority or Other|||||||0.0008|||||||t-test, 2 sided|||The change of pain symptom from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.|
1756719|NCT00252629|3226668|Superiority or Other|||||||0.0002|||||||t-test, 2 sided|||The change of fatigue complaint from baseline (before treatment) to post treatment ( after 3 weeks treatment) on either therapeutic CPAP or sham CPAP was compared with student t-test.|
1756720|NCT00252590|3226670|Superiority or Other|||||||0.32|||||||ANOVA||||
1756721|NCT00252538|3226676|Superiority or Other||||||>|0.05|||||||ANOVA|||All statistics employed Statistical Package for Social Science (SPSS) 17.0. Analysis of variances were used to compare viral responses in genotypes of interest, employing Scheffe’s post-hoc analyses. Repeated-measure mixed-effect analyses were used to compare changes in subjective symptoms over time, including age, gender, and self identified race as covariates. Kaplan–Meier survival analyses examining time until MDD development were compared using theMantel–Cox log rank test.|
1756722|NCT00252512|3226677|Superiority|||||||0.12||||||A priori threshold of <.05|Chi-squared|||Analysis for 12 month follow-up.|
1756723|NCT00252512|3226677|Superiority|||||||0.8||||||A priori threshold of <.05|Chi-squared|||Analysis for 6 month follow-up.|
1756724|NCT00252512|3226677|Superiority|||||||0.05||||||A priori threshold of <.05|Chi-squared|||Analysis for 8 week follow-up|
1756725|NCT00252512|3226678|Superiority|||||||0.19||||||a priori threshold <.05|Chi-squared|||Analysis for 12 month follow up.|
1756726|NCT00252512|3226678|Superiority|||||||0.37||||||A priori threshold <.05|Chi-squared|||Analysis for 6 month follow up.|
1756727|NCT00252512|3226678|Superiority|||||||0.66||||||A priori threshold <.05|Chi-squared|||Analysis for 8 week follow-up|
1756728|NCT00252512|3226679|Superiority|||||||0.76||||||A priori threshold <.05|Chi-squared|||Analysis for 12 month follow up|
1756729|NCT00252512|3226679|Superiority|||||||0.013||||||A priori threshold <.05|Chi-squared|||Analysis for 6 month follow up|
1756730|NCT00252512|3226679|Superiority|||||||0.28||||||a priori threshold <.05|Chi-squared|||Analysis for 8 week follow up|
1756731|NCT00252512|3226680|Superiority||||||>|0.05|||||||Estimating Equation mean modeling|||Costs for period between 6 month follow up and 12 month follow up.|
1756732|NCT00252512|3226680|Superiority||||||>|0.05||||||a priori threshold <.05|Estimation Equation mean modeling|||Costs for period between 6 month follow-up and 12 month follow up.|
1756733|NCT00252512|3226681|Superiority|||||||0.0497||||||a prior threshold of .05|t-test, 2 sided|||12 month analysis|
1756734|NCT00252512|3226681|Superiority|||||||0.45||||||a priori threshold of <.05|t-test, 2 sided|||6 month analysis|
1756735|NCT00252512|3226681|Superiority|||||||0.015||||||a priori threshold of <.05|t-test, 2 sided|||8 week analysis|
1756736|NCT00252512|3226682|Superiority||||||<|0.001||||||Above is calculated p value, a priori threshold for significance set at <.05|GEE full factorial modeling||||
1756737|NCT00252187|3226695|Superiority or Other|||||||0.006|||||||Chi-squared||||
1756738|NCT00252187|3226696|Superiority or Other|||||||0.14|||||||Chi-squared||||
1756739|NCT00252187|3226698|Superiority or Other|||||||0.001|||||||Chi-squared||||
1756740|NCT00252187|3226699|Superiority or Other|||||||0.001|||||||Chi-squared|||Change in LV end diastolic volume was compared between two groups|
1756741|NCT00252187|3226699|Superiority or Other|||||||0.004|||||||Chi-squared|||Change in end systolic LV volume index compared between two groups|
1756742|NCT00251862|3226736|Superiority or Other||||||<|0.001|||||||ANCOVA|||The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni’s adjusted multiple comparison procedure.|
1756743|NCT00251862|3226737|Superiority or Other||||||<|0.001|||||||ANCOVA|||The three study groups were compared through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni’s adjusted multiple comparison procedure.|
1756744|NCT00251862|3226738|Superiority or Other||||||<|0.001||||||Pairwise comparisons: DA+YDR vs. Control, P<0.001; DA alone vs. Control, P<0.001|ANCOVA|||The three study groups were compared on cumulative pre-test and post-test knowledge through separate one-factor analysis of covariance (ANCOVA); followed pairwise comparisons using Bonferroni’s adjusted multiple comparison procedure.|
1756745|NCT00251862|3226739|Superiority or Other||Absolute Difference|6.0||||0.153|2-Sided|95.0|0.2|16.5|||Chi-squared||||
1757105|NCT00242710|3227533|Superiority or Other||||||<|0.826|||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.|
1756746|NCT00251862|3226739|Superiority or Other||Absolute Difference|8.3||||0.046|2-Sided|95.0|-2.2|14.2|||Chi-squared|||Sample size and power considerations focused on a two-group comparison of the DA alone versus control study arms for the primary outcome of colorectal cancer (CRC) screening test completion at 12 months. Based on crude estimates of baseline test completion rates, we calculated that a target sample of 275 subjects per arm provided greater than 80% power of detecting a 54% vs. 40% difference at the P<0.05 level.|
1756747|NCT00251758|3226741|Superiority or Other|||||||0.3874||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1756748|NCT00251758|3226741|Superiority or Other||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1756749|NCT00251758|3226741|Superiority or Other||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1756750|NCT00251758|3226743|Superiority or Other|||||||0.15505||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1756751|NCT00251758|3226743|Superiority or Other||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1756752|NCT00251758|3226743|Superiority or Other||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1756753|NCT00251745|3226745|Superiority or Other|||||||0.3874||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1756754|NCT00251745|3226745|Superiority or Other||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1756755|NCT00251745|3226745|Superiority or Other||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1756756|NCT00251745|3226747|Superiority or Other|||||||0.15505||||||Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1756757|NCT00251745|3226747|Superiority or Other||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1756758|NCT00251745|3226747|Superiority or Other||||||<|1e-05||||||The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.|Wilcoxon (Mann-Whitney)|||The comparison between the two treatment groups was made using Wilcoxon rank-sum test.|
1756759|NCT00251719|3226748|Superiority or Other|||||||0.949||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank||||
1756760|NCT00251719|3226748|Superiority or Other|||||||0.124||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank||||
1756761|NCT00251719|3226748|Superiority or Other|||||||0.117||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank||||
1756762|NCT00251719|3226749|Superiority or Other|||||||0.993||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel||||
1756763|NCT00251719|3226749|Superiority or Other|||||||0.125||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel||||
1756764|NCT00251719|3226749|Superiority or Other|||||||0.1||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel||||
1756765|NCT00251719|3226750|Superiority or Other|||||||0.413||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank||||
1756766|NCT00251719|3226750|Non-Inferiority or Equivalence|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|3.39||||0.03||95.0|0.27|6.5||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank||||
1756767|NCT00251719|3226750|Non-Inferiority or Equivalence|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|1.65||||0.167||95.0|-1.65|4.96||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank||||
1759153|NCT00191139|3230717|Superiority or Other|||||||0.38|||||||Log Rank||||
1756769|NCT00251719|3226751|Superiority or Other|||||||0.064||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank||||
1756770|NCT00251719|3226751|Superiority or Other|||||||0.727||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank||||
1756771|NCT00251719|3226752|Superiority or Other|||||||0.034||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel||||
1756772|NCT00251719|3226752|Superiority or Other|||||||0.064||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel||||
1756773|NCT00251719|3226752|Superiority or Other|||||||0.768||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel||||
1756774|NCT00251719|3226753|Superiority or Other|||||||0.22||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel||||
1756775|NCT00251719|3226753|Non-Inferiority or Equivalence|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 90 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|4.85||||0.019||95.0|1.2|8.5||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel||||
1756776|NCT00251719|3226753|Non-Inferiority or Equivalence|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|2.34||||0.234||95.0|-1.45|6.14||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel||||
1756777|NCT00251693|3226754|Superiority or Other|||||||0.211||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank||||
1756778|NCT00251693|3226754|Superiority or Other|||||||0.241||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank||||
1756779|NCT00251693|3226754|Superiority or Other|||||||0.896||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank||||
1756780|NCT00251693|3226755|Superiority or Other|||||||0.283||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel||||
1756781|NCT00251693|3226755|Superiority or Other|||||||0.146||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel||||
1756782|NCT00251693|3226755|Superiority or Other|||||||0.705||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel||||
1756783|NCT00251693|3226756|Superiority or Other|||||||0.707||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel||||
1756784|NCT00251693|3226756|Non-Inferiority or Equivalence|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|6.08||||0.029||95.0|2.16|10.0||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank||||
1756785|NCT00251693|3226756|Non-Inferiority or Equivalence|Noninferiority was supported if the lower bound of the 95% CI for the difference with lansoprazole 30 mg of the estimated 8-week healing rate was greater than -10%. Superiority was assessed based on log-rank tests comparing treatments for the endpoints.|Difference in percentage|6.2||||0.06||95.0|2.3|10.11||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Log Rank||||
1756786|NCT00251693|3226757|Superiority or Other|||||||0.927||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Log Rank||||
1756787|NCT00251693|3226757|Superiority or Other|||||||0.017||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank||||
1756788|NCT00251693|3226757|Superiority or Other|||||||0.011||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Log Rank||||
1756789|NCT00251693|3226758|Superiority or Other|||||||0.245||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel||||
1756790|NCT00251693|3226758|Superiority or Other|||||||0.045||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel||||
1757016|NCT00244101|3227421|Superiority or Other||Risk Ratio (RR)|0.365|Standard Deviation|0.05|<|0.05|2-Sided|95.0|||||Chi-squared|||PS group used as standard of care. Relative risk and 95 % CI calculated for NCPAP group and ISX group compared to PS group.|
1756791|NCT00251693|3226758|Superiority or Other|||||||0.002||||||Unadjusted p-value is presented. Statistical significance was determined at 0.05 level by Hommel-Simes method within treatment and Hochberg method for comparisons of each dexlansoprazole dose to lansoprazole.|Cochran-Mantel-Haenszel||||
1756792|NCT00251693|3226759|Superiority or Other|||||||0.727||||||Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel||||
1756793|NCT00251693|3226759|Non-Inferiority or Equivalence|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 90 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|6.84||||0.001||95.0|2.7|10.98||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel||||
1756794|NCT00251693|3226759|Non-Inferiority or Equivalence|If the lower bound of the 95% CI was greater than -10%, noninferiority was concluded. Superiority of primary efficacy endpoint was assessed by comparing the crude healing rate of dexlansoprazole MR 60 mg dose to that of lansoprazole 30 mg using a Cochran Mantel Haenszel (CMH) test with baseline LA EE Grade as strata.|Difference in percentage|6.33||||0.004||95.0|2.17|10.48||Unadjusted p-value is presented. The overall 0.05 level of significance for the multiple comparisons of each dexlansoprazole dose to lansoprazole was controlled using Hochberg's method.|Cochran-Mantel-Haenszel||||
1756795|NCT00251641|3226760|Superiority or Other||||||<|0.001||||||Multiplicity adjustment was provided using the Hochberg test.|Chi-squared|Pearson's chi-square test|||
1756796|NCT00251641|3226761|Superiority or Other||||||<|0.001||||||Multiplicity adjustment was provided using the Hochberg test.|Chi-squared|Pearson's chi-square test|||
1756797|NCT00251641|3226762|Superiority or Other||||||<|0.001||||||Multiplicity adjustment was provided using Hochberg test.|Chi-squared|Pearson's chi-square test|||
1756798|NCT00251641|3226763|Superiority or Other||||||<|0.001|||||||Chi-squared|Pearson's chi-square test||The treatment comparison for this endpoint was carried at the 4.9% level of significance.|
1756799|NCT00251303|3226774|Superiority or Other|||||||0.959|||||||Chi-squared||||
1756800|NCT00251004|3226781|Non-Inferiority or Equivalence|The non-inferiority margin was set at -8 mL/min/1.73m^2.|Mean Difference (Net)|-0.83|||<|0.001|2-Sided|95.0|-4.9|3.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|t-test, 2 sided|||The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m^2 or more.|
1756801|NCT00251004|3226781|Non-Inferiority or Equivalence|The non-inferiority margin was set at -8 mL/min/1.73m^2.|Mean Difference (Net)|2.42|||<|0.001|2-Sided|95.0|-1.6|6.5||To control for multiple comparisons, the two-sided significance level was set at 0.025.|t-test, 2 sided|||The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m^2 or more.|
1756802|NCT00251004|3226782|Non-Inferiority or Equivalence|The non-inferiority margin was set at 10%.|Difference in percentage|-3.8|||<|0.001|2-Sided|95.0|-10.8|3.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in composite efficacy failure rates is <10%.|
1756803|NCT00251004|3226782|Non-Inferiority or Equivalence|The non-inferiority margin was set at 10%.|Difference in percentage|1.8|||<|0.014|2-Sided|95.0|-5.5|9.1||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z - test|||Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in percentage of participants composite efficacy failure is <10%.|
1756804|NCT00251004|3226783|Non-Inferiority or Equivalence|The non-inferiority margin was set at 10%.|Difference in Percentage|0.3|||<|0.001|2-Sided|95.0|-4.6|5.2||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is <10%.|
1756805|NCT00251004|3226783|Non-Inferiority or Equivalence|The non-inferiority margin was set at 10%.|Difference in percentage|2.2|||<|0.001|2-Sided|95.0|-2.9|7.3||To control for multiple comparisons, the two-sided significance level was set at 0.025.|Z-test|||Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is <10%.|
1756806|NCT00250588|3226833|Superiority or Other||Odds Ratio (OR)|0.33||||0.011|2-Sided|95.0|0.13|0.82|||Regression, Logistic|All analyses accounted for repeated measures and included the same terms in the model described previously.||Symptom frequency and utilization were analyzed using generalized linear mixed models (GLMM), with appropriate distribution and link functions. Nighttime symptoms is a dichotomous outcome and a logistic model was constructed.|
1756807|NCT00250588|3226834|Superiority or Other||Odds Ratio (OR)|1.22||||0.85|2-Sided|95.0|0.53|2.83||adjustment for age, race/ethnicity, Spanish language and mother’s education|Regression, Logistic||||
1756808|NCT00250588|3226834|Superiority or Other||Odds Ratio (OR)|0.49||||0.21|2-Sided|95.0|0.18|1.38|||Regression, Logistic|Adjustment for age, race/ethnicity, Spanish language and mother’s education|||
1756809|NCT00250588|3226835|Superiority or Other||Mean Difference (Net)|3.1||||0.05|2-Sided|95.0|-0.21|6.4||Bonferroni adjustment|Mixed Models Analysis|Adjusted for child's age, race/ethnicity, Spanish, mother's education.||The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.|
1756842|NCT00249795|3226892|Superiority or Other||Hazard Ratio (HR)|0.916||||0.2162|2-Sided|95.0|0.796|1.053||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of a stroke in Irbesartan group versus Placebo group.||
1756810|NCT00250588|3226835|Superiority or Other||Mean Difference (Net)|4.0||||0.05|2-Sided|95.0|0.63|7.4||Bonferroni adjustment.|Mixed Models Analysis|Adjusted for child’s age, race/ethnicity, Spanish, mother’s education.||The primary effects of interest, condition and condition by time are fixed effects. PedsQL™ scores were analyzed as continuous normal outcomes with mixed effects regression models, which accounts for repeated measures over time for T2 and T3. Independent variables included baseline measure, time, asthma severity, condition, and condition by time interaction. We report the differences across groups in the adjusted mean changes over time.|
1756811|NCT00250432|3226847|Superiority or Other||Rate Difference|6.3|Standard Error of the Mean|12.1||||95.0|-5.9|18.4|||||The 95% confidence interval on the difference will be based on the method of Miettinen and Nurminen.|There was no formal hypothesis testing for efficacy in this study. The main efficacy analysis was the number (percentage) of patients with a favorable overall response at the end of caspofungin study therapy, together with the within treatment 95% exact binomial confidence intervals, and the estimated treatment difference, and its 95% confidence interval.|
1756812|NCT00250432|3226848|Non-Inferiority or Equivalence|Safety with caspofungin 150 mg daily will be non-inferior to that of caspofungin 70/50 mg. Non-inferiority was defined as upper limit of the 2-sided, 95% confidence interval for the difference (150-mg group - 70/50-mg group) must be less than 0.15 (15 percentage points).|Rate Difference|1.1|Standard Error of the Mean|5.6||||95.0|-4.1|6.8|||||The confidence interval computation was based on the method by Miettinen and Nurminen.|A significant drug-related adverse event was defined as either a drug-related serious adverse event or a drug-related adverse event leading to discontinuation of caspofungin therapy. Comparison between the 2 caspofungin groups was based on upper bound of the 95% confidence interval for the difference.|
1756813|NCT00250276|3226864|Non-Inferiority or Equivalence (legacy)|The second primary objective was reached as the upper limit of the 95% CI of the GMC rates anti-HPV-18 antibodies was below 2%.|GMC ratio for anti-HPV-18 antibody|0.8|||||2-Sided|95.0|0.66|0.97||||||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).|
1756814|NCT00250276|3226864|Non-Inferiority or Equivalence (legacy)|The second primary objective was reached as the upper limit of the 95% CI of the GMC rates for anti-HPV-16 was below 2%.|GMC ratio for anti-HPV-16 antibody|0.87|||||2-Sided|95.0|0.7|1.08||||||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).|
1756815|NCT00250276|3226864|Non-Inferiority or Equivalence (legacy)|The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-18 antibodies was below 5%.|Difference in seroconversion rate|0.0|||||2-Sided|95.0|-3.18|0.94||||||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, on month after the third dose (Month 7).|
1756816|NCT00250276|3226864|Non-Inferiority or Equivalence (legacy)|The second primary objective was reached as the upper limit of the 95% CI of the difference in seroconversion rates for anti-HPV-16 antibodies was below 5%.|Difference in seroconversion rate|0.0|||||2-Sided|95.0|-3.63|1.02||||||To demonstrate that the Cervarix™ vaccine produced at 600L manufacturing scale was non-inferior in terms of immunogenicity to the Cervarix™ vaccine produced at 80L scale, one month after the third dose (Month 7).|
1756817|NCT00250276|3226864|Non-Inferiority or Equivalence (legacy)|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.24|||||2-Sided|95.0|1.0|1.55||||||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.|
1756818|NCT00250276|3226864|Non-Inferiority or Equivalence (legacy)|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-16 antibodies.|GMT ratio for anti-HPV-16 antibody|1.21|||||2-Sided|95.0|0.94|1.55||||||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.|
1756819|NCT00250276|3226864|Non-Inferiority or Equivalence (legacy)|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.48|||||2-Sided|95.0|1.18|1.85||||||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.|
1756820|NCT00250276|3226864|Non-Inferiority or Equivalence (legacy)|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-16 antibodies.|GMC ratio for anti-HPV-16 antibody|1.26|||||2-Sided|95.0|0.98|1.63||||||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.|
1756821|NCT00250276|3226864|Non-Inferiority or Equivalence (legacy)|The first primary objective was reached as the 95% CIs of the GMC ratio between lots were within [0.5;2] for the anti-HPV-18 antibodies.|GMC ratio for anti-HPV-18 antibody|1.19|||||2-Sided|95.0|0.95|1.49||||||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.|
1756873|NCT00248040|3227049|Other|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-4.582||||0.1797|2-Sided|95.0|-11.3|2.17|||Other|||This analysis refers to the 10-12 hours time point.|
1759154|NCT00191139|3230718|Superiority or Other|||||||0.08|||||||Log Rank||||
1756822|NCT00250276|3226864|Non-Inferiority or Equivalence (legacy)|The first primary objective was reached as the 95% Confidence Interval (CI) of the GMC ratio between lots was within [0.5;2] for the anti-HPV-16 antibodies.|GMC ratio for anti-HPV-16 antibody|1.04|||||2-Sided|95.0|0.81|1.34||||||To demonstrate lot-to-lot consistency in terms of immunogenicity between the 3 industrial production lots (600L scale) of the Cervarix™ vaccine, one month post dose 3 (Month 7). If consistency was demonstrated the 3 lots would be pooled and non-inferiority of the 600L scale lot vaccine versus the 80L scale would be evaluated as a second primary objective.|
1756823|NCT00249873|3226865|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1756824|NCT00249873|3226866|Superiority or Other||Hazard Ratio (HR)|0.98||||0.696||95.0|0.89|1.08||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of death from any cause for the clopidogrel group compared with the Placebo group.||
1756825|NCT00249873|3226867|Superiority or Other||Hazard Ratio (HR)|0.72|||<|0.001||95.0|0.62|0.83||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of stroke for the clopidogrel group compared with the Placebo group.||
1756826|NCT00249873|3226868|Superiority or Other||Hazard Ratio (HR)|0.89||||0.0133||95.0|0.81|0.98||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of any component of the primary event for the clopidogrel group compared with the Placebo group.||
1756827|NCT00249821|3226878|Superiority or Other|||||||0.055|||||||ANCOVA|||"Month 12: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."|
1756828|NCT00249821|3226878|Superiority or Other|||||||0.793|||||||ANCOVA|||"Month 6: ANCOVA method with covariates height and age at baseline was used to calculate presented p-value."|
1756829|NCT00249821|3226879|Superiority or Other|||||||0.026|||||||ANCOVA|||Month 12: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.|
1756830|NCT00249821|3226879|Superiority or Other|||||||0.058|||||||ANCOVA|||Month 6: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.|
1756831|NCT00249821|3226880|Superiority or Other|||||||0.972|||||||ANCOVA|||Change at Month 12: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.|
1756832|NCT00249821|3226881|Superiority or Other|||||||0.029|||||||ANCOVA|||Change at Month 6: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.|
1756833|NCT00249821|3226882|Superiority or Other|||||||0.002|||||||ANCOVA|||Month 12: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.|
1756834|NCT00249821|3226882|Superiority or Other|||||||0.022|||||||ANCOVA|||Month 6: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.|
1756835|NCT00249821|3226883|Superiority or Other|||||||0.002|||||||ANCOVA|||Change at Month 12: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.|
1756836|NCT00249821|3226883|Superiority or Other|||||||0.012|||||||ANCOVA|||Change at Month 6: ANCOVA method with covariates “height” and “age” at baseline was used to calculate presented p-value.|
1756837|NCT00249821|3226884|Superiority or Other|||||||0.001|||||||ANCOVA|||Month 12: Analysis of co-variance (ANCOVA) method with covariates “height” and “age” at baseline was used to calculate presented p-value.|
1756838|NCT00249795|3226888|Superiority or Other||Hazard Ratio (HR)|1.008||||0.8377|2-Sided|95.0|0.93|1.093||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of hospitalization for other CV cause in Irbesartan group versus Placebo group.||
1756839|NCT00249795|3226889|Superiority or Other||Hazard Ratio (HR)|0.863||||0.0175|2-Sided|95.0|0.763|0.975||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of hospitalization for Heart Failure in Irbesartan group versus Placebo group.||
1756840|NCT00249795|3226890|Superiority or Other||Hazard Ratio (HR)|0.897||||0.0369|2-Sided|95.0|0.809|0.993||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of HF episodes in Irbesartan group versus Placebo group.||
1756841|NCT00249795|3226891|Superiority or Other||Hazard Ratio (HR)|1.014||||0.759|2-Sided|95.0|0.927|1.11||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 5% level.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of death in Irbesartan group versus Placebo group.||
1756929|NCT00246025|3227196|Superiority or Other|||||||0.496|||||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events|
1759155|NCT00191139|3230719|Superiority or Other||Response rate|84.4||||||95.0|67.2|94.7|||||||
1756843|NCT00249795|3226893|Superiority or Other||Hazard Ratio (HR)|0.94||||0.12|2-Sided|95.0|0.869|1.016||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 1% level to account for multiplicity.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of any component of the composite event in Irbesartan group versus Placebo group.||
1756844|NCT00249795|3226894|Superiority or Other||Hazard Ratio (HR)|0.992||||0.857|2-Sided|95.0|0.907|1.085||The cumulative incidence function of this event was calculated for each treatment group using the non-parametric Kaplan-Meier method and the comparison was performed using a 2-sided Log Rank test at 4.5% level to account for multiplicity.|Log Rank|Logrank statistic was stratified on ACTIVE A/W strata.|HR was estimated using a Cox's proportional hazard model stratified on ACTIVE A/W strata with treatment group factor. It provides the relative hazard of any component of the composite event in Irbesartan group versus Placebo group.||
1756845|NCT00249613|3226902|Superiority or Other||Odds Ratio (OR)|0.42|Standard Error of the Mean|0.34||0.01|2-Sided|95.0|0.22|0.82|||Regression, Logistic||The direction of the comparison would dictate that odds ratio of less than 1 would indicate Women-Only treatment participants are less likely than the Mixed-Gender group to use drugs or alcohol during the 30 days prior to the 12-Mo follow-up.|Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.|
1756846|NCT00249613|3226903|Superiority or Other||Beta coefficient|-0.7|Standard Error of the Mean|0.72||0.33|2-Sided|95.0|-2.11|0.7|||Generalized estimating equations (GEE)|||Generalized estimating equation (GEE) models do not separate arms: group status (women-only vs mixed-gender) is the dependent variable. Because we were not able to randomly assign, we also included a propensity score, and additional variables (education, race/ethnicity, marital status, income, history of sexual abuse, criminal justice funding source, had child, mental health symptoms, and a time in treatment by group interaction term) to adjust for the non-random sampling.|
1756847|NCT00249613|3226904|Superiority or Other||Odds Ratio (OR)|0.4|Standard Error of the Mean|0.34||0.01|2-Sided|95.0|0.21|0.79||Odds ratio is 0.40, confidence interval is 0.21—0.79.|Regression, Logistic||The direction of the comparison would dictate that odds ratio of less than 1 would indicate Women-Only participants are less likely than Mixed-Gender participants to engage in criminal activities.|Logistic regression does not separate arms because group status (women-only vs mixed gender) is the dependent variable in our multinomial logistic regression. Because we were not able to randomly assign after all, we also included a propensity score, and additional variables (substance use in past 30 days at baseline, age, race/ethnicity, childhood sexual abuse history, previous treatment, criminal justice funding source, and primary drug) to adjust for the non-random sampling.|
1756848|NCT00249496|3226906|Superiority||Odds Ratio (OR)|0.0||||0.046|2-Sided|95.0|0.0|0.0|||General Estimating Equation (GEE)||The Odds Ratio and Confidence Intervals could not be calculated because one of the groups was at 0.||
1756849|NCT00249496|3226908|Superiority||Odds Ratio (OR)|0.8|||=|0|2-Sided|95.0|0.26|2.43|||General Estimating Equation (GEE)||||
1756850|NCT00249496|3226910|Superiority||Odds Ratio (OR)|3.73||||0.004|2-Sided|95.0|1.6|8.69|||General Estimating Equation (GEE)||||
1756851|NCT00249470|3226911|Superiority||Odds Ratio (OR)|3.37||||0.04|2-Sided|95.0|1.21|9.37|||General Estimating Equation (GEE)||||
1756852|NCT00249470|3226912|Superiority||Odds Ratio (OR)|0.91|||=|0|2-Sided|95.0|0.4|2.08|||General Estimating Equation (GEE)||||
1756853|NCT00249470|3226913|Superiority or Other||Odds Ratio (OR)|5.8||||0.004|2-Sided|95.0|2.03|16.56|||General Estimating Equation (GEE)||||
1756854|NCT00248794|3226968|Superiority or Other|||||||0.77|||||||ANOVA||||
1756855|NCT00248794|3226969|Superiority or Other||||||<|0.97|||||||ANOVA||||
1756856|NCT00248651|3226980|Superiority or Other|||||||0.04|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Work/Study subscale. A p-value of <0.05 was considered statistically significant.|
1756857|NCT00248651|3226980|Superiority or Other|||||||0.01|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Sleep Disturbance subscale. A p-value of <0.05 was considered statistically significant.|
1756858|NCT00248651|3226980|Superiority or Other|||||||0.06|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Interference subscale. A p-value of <0.05 was considered statistically significant.|
1756859|NCT00248651|3226980|Superiority or Other|||||||0.06|||||||ANCOVA|||Comparison between antidepressant arms and placebo for Eat/Drink subscale. A p-value of <0.05 was considered statistically significant.|
1756860|NCT00248651|3226980|Superiority or Other|||||||0.02|||||||ANCOVA|||Comparison between antidepressant arms and placebo for overall quality of life. A p-value of <0.05 was considered statistically significant.|
1756861|NCT00248651|3226983|Superiority or Other|||||||0.05|||||||ANCOVA|||Overall treatment effect from logistic regression model incorporating balancing factors. A p-value of <0.05 was considered statistically significant.|
1756862|NCT00248625|3226989|Superiority or Other|||||||0.86|||||||Chi-squared||||
1756863|NCT00248625|3226990|Superiority or Other|||||||0.54|||||||Cochran-Armitage tren||||
1756864|NCT00248625|3226991|Superiority or Other|||||||0.74|||||||Cochran-Armitage trend||||
1756865|NCT00248625|3226992|Superiority or Other|||||||0.29|||||||Cochran-Armitage trend||||
1756866|NCT00248625|3226993|Superiority or Other|||||||0.053|||||||Kruskal-Wallis||||
1756867|NCT00248625|3226994|Superiority or Other|||||||0.21|||||||Pepe and Mori test of CIF difference||||
1756868|NCT00248625|3226995|Superiority or Other|||||||0.03|||||||Log Rank||||
1756869|NCT00248625|3226996|Superiority or Other|||||||0.19|||||||Log Rank||||
1756870|NCT00248560|3227009|Superiority or Other||Response rate|0.17|||||2-Sided|95.0|0.08|0.32|||||||
1756871|NCT00248547|3227013|Superiority or Other|||||||0.041|||||||Wilcoxon Rank Sum Test||||
1756872|NCT00248170|3227035|Superiority or Other|||||||0.315|||||||Log Rank||||
1756874|NCT00248040|3227049|Superiority|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|4.519||||0.1934|2-Sided|95.0|-2.36|11.39|||Other|||This analysis refers to the 10-12 hours timepoint.|
1756875|NCT00248040|3227049|Superiority|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-0.063||||0.9855|2-Sided|95.0|-6.91|6.79|||Other|||This analysis refers to the 10-12 hours time point.|
1756876|NCT00248040|3227049|Other||Difference between means|-2.719||||0.2565|2-Sided|95.0|-7.47|2.03|||Other||||
1756877|NCT00248040|3227049|Superiority|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|2.444||||0.3084|2-Sided|95.0|-2.32|7.21|||Other|||This analysis refers to the 1-3 hours timepoint.|
1756878|NCT00248040|3227049|Superiority|The model included fixed effect terms for center, time point, and treatment. Time point was specified as a repeated measurement.|Difference between means|-0.275||||0.9076|2-Sided|95.0|-5.0|4.45|||Other|||This analysis refers to the 1-3 hours time point|
1756879|NCT00247962|3227050|Superiority or Other|||||||0.01|||||||ANCOVA|||week 16|
1756880|NCT00247962|3227050|Superiority or Other|||||||0.719|||||||ANCOVA|||baseline|
1756881|NCT00247962|3227051|Superiority or Other||Risk Difference (RD)|22.99|||<|0.001|||||||Cochran-Mantel-Haenszel||||
1756882|NCT00247676|3227065|Superiority or Other||probability|0.324||||||95.0|0.168|0.479|||||probability derived from Kaplan-Meier estimate.||
1756883|NCT00247676|3227069|Superiority or Other||objective response rate|2.7||||||95.0|0.1|14.2|||||percentage of patients with confirmed CR or confirmed PR according to RECIST, relative to the total number of treated patients.||
1756884|NCT00247676|3227074|Superiority or Other||clinical benefit response rate|37.8||||||95.0|22.5|55.2|||||Clinical benefit response rate: percent of patients with confirmed CR, confirmed PR, or SD for at least 12 weeks according to RECIST, relative to total treated patients.||
1756885|NCT00247611|3227081|Superiority or Other||||||<|0.01|||||||Chi-squared|||P-value for difference of participants on disability between On Protocol (OP) sample, and participants excluded from on protocol analysis.|
1756886|NCT00247611|3227081|Superiority or Other||||||<|0.001|||||||Chi-squared|||P-value for difference in unemployment rate between On Protocol (OP) sample, and participants excluded from on protocol analysis.|
1756887|NCT00247611|3227082|Superiority or Other|||||||0.12||||||The p-value was not adjusted for multiple comparisons, and is reported as 0.12 at alpha 0.05 two tailed.|HLM|||For the on protocol sample the pattern of increased proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.|
1756888|NCT00247611|3227082|Superiority or Other|||||||0.12||||||The p-value was not adjusted for multiple comparisons and is reported as 0.12 at alpha 0.05 two tailed|HLM|||For the ITT sample (t=586) the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from baseline was associated with a p-value of 0.12, alpha 0.05 two-tailed.|
1756889|NCT00247611|3227083|Superiority or Other||||||>|0.5||||||No adjustments were made.|Generalized Linear Model (GLM)|||For the ITT or OP samples, the significance threshold between groups over time for differential increases in proportion with suppressed (undetectable) viral load was p > 0.50. The study was underpowered to detect differences in Viral load.|
1756890|NCT00247611|3227084|Superiority or Other|||||||0.024||||||The p-value was not adjusted for multiple comparisons, and thresholds for significance was 0.05 alpha, two tailed.|HLM|||For the on protocol sample, study arm was associated with perfect ACTG-assessed 3-day ARV adherence at p = 0.024, alpha two-tailed.|
1756891|NCT00247611|3227084|Superiority or Other|||||||0.12||||||The p-value was not adjusted for multiple comparisons, and thresholds for significance were 0.05 alpha two tailed.|HLM|||For the ITT sample, the observed pattern of an increasing proportion of participants in the intervention arm reporting perfect adherence as time progressed from was associated with a p-value of 0.12, two-tailed alpha 0.05.|
1756892|NCT00247273|3227099|Superiority or Other||Risk Ratio (RR)|0.98||||1|2-Sided|95.0|0.47|2.03|||Fisher Exact||||
1756893|NCT00247273|3227100|Superiority or Other||Risk Ratio (RR)|0.96||||1|2-Sided|95.0|0.36|2.54|||Fisher Exact||||
1756894|NCT00247273|3227101|Superiority or Other||Mean Difference (Final Values)|-0.77|||||2-Sided|95.0|-3.96|2.43|||||||
1756895|NCT00247273|3227102|Superiority or Other||Mean Difference (Final Values)|0.12|||||2-Sided|95.0|-0.45|0.7|||||||
1756896|NCT00247273|3227103|Superiority or Other||Mean Difference (Final Values)|1.31|||||2-Sided|95.0|-0.85|3.48|||||||
1756897|NCT00247273|3227104|Superiority or Other||Mean Difference (Final Values)|0.17|||||2-Sided|95.0|-0.29|0.64|||||||
1756898|NCT00247273|3227105|Superiority or Other||Mean Difference (Final Values)|-5.69|||||2-Sided|95.0|-12.04|0.66|||||||
1756899|NCT00247273|3227106|Superiority or Other||Mean Difference (Final Values)|-0.02|||||2-Sided|95.0|-0.06|0.01|||||||
1756900|NCT00247273|3227107|Superiority or Other||Mean Difference (Final Values)|-4.17|||||2-Sided|95.0|-7.98|-0.36|||||||
1756901|NCT00247273|3227108|Superiority or Other||Mean Difference (Final Values)|-0.02|||||2-Sided|95.0|-0.05|0.0|||||||
1756902|NCT00247273|3227109|Superiority or Other||Mean Difference (Final Values)|-2.83|||||2-Sided|95.0|-6.45|0.8|||||||
1756903|NCT00247273|3227110|Superiority or Other||Mean Difference (Final Values)|1.0|||||2-Sided|95.0|-2.54|4.53|||||||
1756904|NCT00247273|3227111|Superiority or Other||Mean Difference (Final Values)|-1.57|||||2-Sided|95.0|-4.47|1.33|||||||
1756905|NCT00247273|3227112|Superiority or Other||Mean Difference (Final Values)|0.23|||||2-Sided|95.0|-2.83|3.28|||||||
1756906|NCT00247273|3227113|Superiority or Other||Mean Difference (Final Values)|-0.0009|||||2-Sided|95.0|-0.0048|0.0029|||||||
1756907|NCT00247273|3227114|Superiority or Other||Mean Difference (Final Values)|-0.085|||||2-Sided|95.0|-0.609|0.439|||||||
1756930|NCT00246025|3227196|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events|
1757017|NCT00243932|3227423|Superiority or Other|||||||0.14|||||||futility (non-superiority)|||Null hypothesis: 2,700mg CoQ10 is at least 20% superior to placebo.|
1756908|NCT00247273|3227115|Non-Inferiority or Equivalence|The estimates of the common SD, dropout rate at month 24 and true difference are also based on previous risedronate Phase III studies (RVN008993, RVE009093, ROE009394, HMR4003E/3001).|LS Mean Difference|-0.239|||||2-Sided|95.0|-0.727|0.249||||||The sample size of 1068 patients will provide approximately 90% power to demonstrate the noninferiority of the monthly regimen at month 24, using a 2% noninferiority margin and assuming a common SD of the percent change from baseline in lumbar spine BMD at month 24 of 5%, a 2-year dropout rate of 30%, and a true mean difference (uDaily-uMonthly) of 0.8%.|
1756909|NCT00247273|3227116|Superiority or Other||LS Mean Difference|-0.0005|||||2-Sided|95.0|-0.0035|0.0024|||||||
1756910|NCT00247273|3227117|Superiority or Other||LS Mean Difference|-0.076|||||2-Sided|95.0|-0.475|0.323|||||||
1756911|NCT00247273|3227118|Non-Inferiority or Equivalence|In order to establish noninferiority for the primary efficacy variable at one-sided α of 2.5% with 90% power, a total of 1068 patients, 534 per treatment group, is required. This calculation is based on the following assumptions: the noninferiority margin (or delta) = 1.5%, the common SD (standard deviation) of the percent change from baseline in lumbar spine BMD at Month 12 = 4.5%, the 1 year dropout rate = 20%, and the true mean difference μD - μM = 0.5%.|Least Square (LS) Mean Difference|-0.115|||||2-Sided|95.0|-0.505|0.274|||||||
1756912|NCT00246805|3227119|Superiority or Other||Proportions|48.0|||<|0.0001|2-Sided|95.0|36.0|61.0|||Z-test for proportions|||VRS ON vs. VRS OFF|
1756913|NCT00246571|3227151|Superiority or Other||Hazard Ratio (HR)|1.1599||||0.8394|2-Sided|95.0|0.8648|1.5558||One-sided log rank test stratified for the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Log Rank||Hazard ratio for sunitinib versus standard of care.||
1756914|NCT00246571|3227154|Superiority or Other||Odds Ratio (OR)|0.74||||0.814|2-Sided|95.0|0.27|1.98||The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Cochran-Mantel-Haenszel|||Investigator's assessment|
1756915|NCT00246571|3227154|Superiority or Other||Odds Ratio (OR)|0.38||||0.9624|2-Sided|95.0|0.06|1.71||The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.|Cochran-Mantel-Haenszel|||Core radiology laboratory assessment|
1756916|NCT00246571|3227155|Superiority or Other||Hazard Ratio (HR)|1.1598||||0.8472|2-Sided|95.0|0.8703|1.5457||One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from IVRS.|Log Rank|||For investigator's assessment|
1756917|NCT00246571|3227155|Superiority or Other||Hazard Ratio (HR)|1.203||||0.8885|2-Sided|95.0|0.8889|1.628||One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from the interactive voice response system (IVRS).|Log Rank|||For core radiology laboratory assessment|
1756918|NCT00246337|3227168|Superiority or Other||||||<|0.001||||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.|
1756919|NCT00246337|3227169|Superiority or Other||||||<|0.001||||||0.05 is the pre-specified significance level.|generalized linear model|||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.|
1756920|NCT00246337|3227170|Superiority or Other||||||<|0.001||||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis.|
1756921|NCT00246337|3227171|Superiority or Other|||||||0.015||||||0.05 is the pre-specified significance level.|generalized linear model|The p-value is based on the average response of the MK0974 200mg, 400mg, and 600mg groups vs. placebo.||Only the MK0974 300mg, 400mg, and 600mg groups are included in the comparison with placebo based on the protocol-specified test statistics selection and the fact that all lower doses were discontinued after the interim analysis. Overall power =85%|
1756922|NCT00246025|3227196|Superiority or Other||Absolute Difference (Percentage)|2.8||||0.4493|2-Sided|95.0|-4.4|10.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events|
1756923|NCT00246025|3227196|Superiority or Other||Absolute Difference (Percentage)|2.3||||0.5377|2-Sided|95.0|-4.9|9.4|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events|
1756924|NCT00246025|3227196|Superiority or Other||Absolute Difference (Percentage)|1.7||||0.6313|2-Sided|95.0|-5.3|8.7|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category any bleeding events|
1756925|NCT00246025|3227196|Superiority or Other||Absolute Difference (Percentage)|0.7||||0.7802|2-Sided|95.0|-3.9|5.2|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events|
1756926|NCT00246025|3227196|Superiority or Other||Absolute Difference (Percentage)|-2.4||||0.1696|2-Sided|95.0|-5.9|1.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events|
1756927|NCT00246025|3227196|Superiority or Other||Absolute Difference (Percentage)|-2.5||||0.1513|2-Sided|95.0|-5.9|1.0|||normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Absolute difference versus Placebo for the category major and clinically relevant bleeding events|
1756928|NCT00246025|3227196|Superiority or Other|||||||0.6223|||||||Fisher Exact|||Comparison versus Placebo for the category major bleeding events|
1756931|NCT00246025|3227199|Superiority or Other||Risk Difference (RD)|-32.5|||<|0.0001|2-Sided|95.0|-45.4|-19.6||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."|
1756932|NCT00246025|3227199|Superiority or Other||Risk Difference (RD)|-23.7|||<|0.0006|2-Sided|95.0|-37.0|-10.5||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."|
1756933|NCT00246025|3227199|Superiority or Other||Risk Difference (RD)|-16.8|||<|0.0155|2-Sided|95.0|-30.2|-3.4||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."|
1756934|NCT00246025|3227200|Superiority or Other|||||||0.6162||||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher`s exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."|
1756935|NCT00246025|3227200|Superiority or Other|||||||1||||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher`s exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."|
1756936|NCT00246025|3227200|Superiority or Other|||||||0.6107||||||Multiplicity was not adjusted.|Fisher Exact|||"Superiority of dabigatran etexilate to placebo was tested based on Fisher`s exact test.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."|
1756937|NCT00246025|3227201|Superiority or Other||Risk Difference (RD)|-5.8||||0.0138||95.0|-10.3|-1.3||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."|
1756938|NCT00246025|3227201|Superiority or Other||Risk Difference (RD)|-4.0||||0.1183||95.0|-9.1|1.1||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."|
1756939|NCT00246025|3227201|Superiority or Other||Risk Difference (RD)|-4.0||||0.1124||95.0|-9.1|1.0||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||"Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.~The dabigatran groups were compared to the placebo group.. The null hypotheses are Ho: placebo = 220mg, Ho: placebo = 150mg and Ho: placebo = 110mg. ,All comparisons were two-sided with a significance level of 5%. Confidence intervals were two-sided with a level of 95%."|
1756940|NCT00246025|3227202|Superiority or Other||Risk Difference (RD)|-5.8||||0.0138||95.0|-10.3|-1.3||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|
1756941|NCT00246025|3227202|Superiority or Other||Risk Difference (RD)|-4.0||||0.1183||95.0|-9.1|1.1||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|
1756942|NCT00246025|3227202|Superiority or Other||Risk Difference (RD)|-4.0||||0.1124||95.0|-9.1|1.0||Multiplicity was not adjusted.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.||Superiority of dabigatran etexilate to placebo was tested. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|
1757015|NCT00244140|3227415|Superiority or Other||Percent Images Rated Good/Excellent: BR1|95.8||||||95.0|93.3|97.6||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).|
1756943|NCT00246025|3227203|Superiority or Other||Risk Difference (RD)|-32.5|||<|0.0001||95.0|-45.4|-19.6||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|
1756944|NCT00246025|3227203|Superiority or Other||Risk Difference (RD)|-23.7|||<|0.0006||95.0|-37.0|-10.5||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|
1756945|NCT00246025|3227203|Superiority or Other||Risk Difference (RD)|-16.8|||<|0.0155||95.0|-30.2|-3.4||Multiplicity was not adjusted because of hierarchical testing from highest to lowest dose.|normal approximation method|Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|The risk differences are calculated as risk in the dabigatran groups minus risk in the placebo group.|Superiority of dabigatran etexilate to placebo was tested by means of hierarchical tests. Statistical inference was made on the basis of the normal approximation of two independent binomial distributions.|
1756946|NCT00245960|3227229|Superiority or Other||Risk Difference (RD)|1.34||||0.791|||||||Cochran-Mantel-Haenszel||||
1756947|NCT00245960|3227230|Superiority or Other||Risk Difference (RD)|14.54|||<|0.001|||||||Cochran-Mantel-Haenszel||||
1756948|NCT00245765|3227243|Superiority||Odds Ratio (OR)|162.6|||<|0.001|2-Sided|95.0|31.4|2999.2|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.||
1756949|NCT00245765|3227243|Superiority||Odds Ratio (OR)|64.1|||<|0.001|2-Sided|95.0|12.7|1169.1|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors. Confidence limits are based on likelihood ratio statistics.|||
1756950|NCT00245765|3227244|Superiority||Odds Ratio (OR)|73.4|||<|0.001|2-Sided|95.0|23.5|292.6|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.||
1756951|NCT00245765|3227244|Superiority||Odds Ratio (OR)|40.2|||<|0.001|2-Sided|95.0|13.7|150.3|||Regression, Logistic|Logistic regression with treatment and baseline severity of psoriasis as factors.|Confidence limits are based on likelihood ratio statistics.||
1756952|NCT00245219|3227305|Superiority or Other||||||>|0.05|||||||Regression, Logistic|||The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.|
1756953|NCT00245219|3227305|Superiority or Other||||||>|0.05|||||||Regression, Logistic|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.|
1756954|NCT00245219|3227305|Superiority or Other||||||>|0.05|||||||Regression, Logistic|||The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.|
1756955|NCT00245219|3227305|Superiority or Other||||||>|0.05|||||||Regression, Logistic|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.|
1756956|NCT00245219|3227305|Superiority or Other||||||>|0.05|||||||Regression, Logistic|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.|
1756957|NCT00245219|3227305|Superiority or Other||||||>|0.05|||||||Regression, Logistic|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.|
1756958|NCT00245219|3227305|Superiority or Other||||||>|0.05|||||||Regression, Logistic|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.|
1757190|NCT00239681|3227687|Superiority or Other||Hazard Ratio (HR)|1.06||||0.548||95.0|0.88|1.28|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)||
1756959|NCT00245219|3227305|Superiority or Other||||||>|0.05|||||||Regression, Logistic|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.|
1756960|NCT00245219|3227306|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The interaction between the peer support condition and breast cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.|
1756961|NCT00245219|3227306|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.|
1756962|NCT00245219|3227306|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The interaction between the peer support condition and breast cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.|
1756963|NCT00245219|3227306|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.|
1756964|NCT00245219|3227306|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.|
1756965|NCT00245219|3227306|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.|
1756966|NCT00245219|3227306|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.|
1756967|NCT00245219|3227306|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.|
1756968|NCT00245219|3227307|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The interaction between the peer support condition and cancer stage at Time 3. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.|
1756969|NCT00245219|3227307|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The interaction between the peer support condition and cancer stage at Time 2. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.|
1756970|NCT00245219|3227307|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 3, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.|
1756971|NCT00245219|3227307|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The comparison between the peer support condition and control condition at Time 2, among both late and early stage patients. The full regression model consisted of 3 steps: The 1st step contained the baseline measure of the dependent variable. The 2nd step contained two dummy coded variables contrasting each condition with control. The 3rd step contained the interaction between the peer support condition and cancer stage. Patients in the education condition were excluded from this analysis.|
1757106|NCT00242710|3227534|Superiority or Other||LS Mean Difference|3.78||||0.077|2-Sided|95.0|-0.41|7.97|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1756972|NCT00245219|3227307|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.|
1756973|NCT00245219|3227307|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 3. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.|
1756974|NCT00245219|3227307|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The comparison between the education condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.|
1756975|NCT00245219|3227307|Superiority or Other||||||>|0.05|||||||Regression, Linear|||The comparison between the peer support condition and the control condition at Time 2. The full regression model included 2 dummy coded variables, 1 contrasting the education and control condition, and 1 contrasting the peer support and control condition. The baseline measure of the outcome variable was included, in order to examine changes in the outcomes over time. This model tested the main effects of the conditions among patients with early stage cancer, late stage patients were excluded.|
1756976|NCT00245050|3227312|Superiority or Other|||||||0.916|||||||t-test, 2 sided||||
1756977|NCT00245050|3227313|Superiority or Other||Risk Ratio (RR)|1.07|||<|0.05|2-Sided|95.0|0.536|2.16|||Chi-squared|||Based on published literature, it is estimated that the incidence of HFS for all grades is 49%. A decrease of 50% or more in the incidence of HFS in patients receiving pyridoxine would be of clinical significance. A sample size of 27 patients per group was chosen as this would allow us to detect a difference between HFS incidence of 49% and 11.5% (alpha=0.05, two-sided, power=0.80). Interim analysis was conducted after 30 patients were enrolled and had evaluable HFS assessment data.|
1756978|NCT00244764|3227347|Superiority or Other||percentage|42.0||||||95.0|29.0|54.0|||||The estimated value is the percentage of the first 60 participants who had stable disease at Week 12, as assessed by the investigator.||
1756979|NCT00244764|3227348|Superiority or Other||percentage|34.7||||||95.0|28.4|40.9|||||The estimated value provided is the response rate.||
1756980|NCT00244751|3227374|Superiority or Other|||||||0.1776|||||||Cochran-Mantel-Haenszel Test|||Comparison for Ranked assessment (necrosis)|
1756981|NCT00244751|3227374|Superiority or Other|||||||0.6483|||||||Cochran-Mantel-Haenszel Test|||Comparison for Ranked assessment (fibrosis)|
1756982|NCT00244751|3227375|Superiority or Other|||||||0.9501|||||||reduced regression model||||
1756983|NCT00244751|3227375|Superiority or Other|||||||0.9157|||||||reduced regression model||||
1756984|NCT00244751|3227376|Superiority or Other|||||||0.3575|||||||reduced regression model||||
1756985|NCT00244751|3227376|Superiority or Other|||||||0.3608|||||||reduced regression model||||
1756986|NCT00244725|3227388|Superiority or Other||Risk Ratio (RR)|1.32||||0.08|2-Sided|95.0|1.0|1.8|||Fisher Exact||||
1756987|NCT00244725|3227388|Superiority or Other||Risk Ratio (RR)|1.42||||0.017|2-Sided|95.0|1.1|1.9|||Fisher Exact||||
1756988|NCT00244725|3227388|Superiority or Other||Risk Ratio (RR)|1.45||||0.012|2-Sided|95.0|1.1|1.9|||Fisher Exact||||
1756989|NCT00244712|3227402|Non-Inferiority or Equivalence|Non-inferiority of the ABC/3TC to the TDF/FTC would be declared if the lower limit of the 2-sided 95% confidence interval on the difference in the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 [ABC/3TC minus TDF/FTC] was -12% or greater.|difference in response percentage|0.39||||0.913||95.0|-6.63|7.4|||Cochran-Mantel-Haenszel||Difference in response percentage = percentage in Arm 1 minus percentage in Arm 2||
1756990|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|1.09||||0.73|2-Sided|95.0|0.59|2.02|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for condom use >90% (if sexually active)|Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for engaging in risk behavior during the past 30 days|
1756991|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|0.91||||0.86|2-Sided|95.0|0.45|1.85|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Traded sex for money or drugs in the past 30 days|Adjusted odds and 95% confidence interval for travel in prior 3 months as a risk factor for risk behaviors in past 30 days|
1756992|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|2.21|||<|0.01|2-Sided|95.0|1.4|3.49|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for Median number of sexual partners >=2 in the past 30 days|Adjusted odds ratios and 95% confidence intervals for travel in prior 3 months as a risk factor for risk behaviors in past 30 days|
1756993|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|1.32|||<|0.13|2-Sided|95.0|0.83|2.1|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|"Adjusted odds for travel in prior 3 months as a risk factor for having done Someone's rinse in the past 30 days"|Adjusted odds with 95% confidence interval for travel in prior 3 months as a risk factor for risk behavior in past 30 days|
1756994|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|1.87|||<|0.01|2-Sided|95.0|1.19|2.95|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having used Backloaded Syringe in the past 30 days|Adjusted odds with 95 % confidence interval for travel as a risk factor for risk behaviors|
1757061|NCT00242710|3227530|Superiority or Other||LS Mean Difference|2.38|||<|0.001|2-Sided|95.0|1.17|3.59|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.|
1756995|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|2.1|||<|0.01|2-Sided|95.0|1.34|3.32|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Shared cooker/spook to prepare drugs in the past 30 days|Adjusted odds ratios with 95% confidence interval for travel in prior 3 months as risk factor for risk behaviors|
1756996|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|3.07|||<|0.01|2-Sided|95.0|1.79|5.27|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Pooled money to buy drugs in the past 30 days|Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Pooled money to buy drugs in the past 30 days|
1756997|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|1.61|||<|0.01|2-Sided|95.0|1.01|2.55|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Injected with someone else's used needle/syringe in the past 30 days|Adjusted odds ratio with 95 % confidence interval for travel in prior 3 months as a risk factor for having injected with someone else's used needle/syringe in the past 30 days|
1756998|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|1.26|||<|0.19|2-Sided|95.0|0.81|1.97|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in prior 3 months as a risk factor for having Lent a needle/syringe in the past 30 days|Adjusted odds with 95% confidence interval for travel in the prior 3 months as a risk factor for having Lent a needle/syringe in the past 30 days|
1756999|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|2.16|||<|0.01|2-Sided|95.0|1.37|3.4|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Median number of injected partners >= 5 in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.|
1757000|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|0.56|||<|0.04|2-Sided|95.0|0.33|0.93|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Injected daily, past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.|
1757001|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|3.63|||<|0.01|2-Sided|95.0|2.02|6.5|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Adjusted odds for travel in the prior 3 months as a risk factor for Drank until blacked out in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.|
1757002|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|6.87|||<|0.01|2-Sided|95.0|3.84|12.28|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for Heavy drinking (>14 and >21 drinks/week for women and men respectively) in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.|
1757003|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|1.99|||<|0.01|2-Sided|95.0|1.11|3.59|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for poly-substance use in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.|
1757004|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|0.59|||<|0.03|2-Sided|95.0|0.35|0.98|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for having Used (injected/snorted/smoked) methamphetamine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.|
1757005|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|1.56|||<|0.05|2-Sided|95.0|1.0|2.44|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the prior 3 months as a risk factor for having Used (injected and/or snorted) crack cocaine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.|
1757006|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|1.76|||<|0.01|2-Sided|95.0|1.12|2.76|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the past 3 months as a risk factor for having Used (injected/snorted/smoked) powder cocaine in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.|
1757007|NCT00244374|3227409|Superiority or Other||Odds Ratio (OR)|1.4|||<|0.05|2-Sided|95.0|0.8|2.44|||Regression, Logistic|Odds ratios adjusted for age, race, sex, years injecting.|Odds for travel in the past 3 months as a risk factor for used (injected/snorted/smoked) heroin in the past 30 days|Adjusted odds with 95% confidence intervals for travel as a risk factor for each behavior.|
1757008|NCT00244140|3227412|Superiority or Other||Percent Images Rated Yes: BR3|99.7||||||95.0|98.6|100.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).|
1757009|NCT00244140|3227412|Superiority or Other||Percent Images Rated Yes: BR2|100.0||||||95.0|99.0|100.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).|
1757010|NCT00244140|3227412|Superiority or Other||Percent Images Rated Yes: BR1|98.4||||||95.0|96.6|99.4||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 1 (BR1).|
1757011|NCT00244140|3227413|Superiority or Other||Percent Images Rated Good/Excellent|99.5||||||95.0|98.1|99.9|||||||
1757012|NCT00244140|3227414|Superiority or Other||Percent Images Rated Yes|99.7||||||95.0|98.6|100.0|||||||
1757013|NCT00244140|3227415|Superiority or Other||Percent Images Rated Good/Excellent: BR3|98.4||||||95.0|96.6|99.4||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 3 (BR3).|
1757014|NCT00244140|3227415|Superiority or Other||Percent Images Rated Good/Excellent: BR2|96.3||||||95.0|93.9|98.0||||||Study was uncontrolled - No comparison between groups. The 95% Confidence Interval (CI) were calculated for each of the 3 blinded readers separately. This analysis refers to the assessment of blinded reader 2 (BR2).|
1757018|NCT00243919|3227425|Superiority or Other||||||<|0.001|||||||ANOVA|Test differences across the three groups in change of ABC score from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757019|NCT00243919|3227425|Superiority or Other||||||<|0.62|||||||ANOVA|Test differences across the three groups in change of ABC score from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757020|NCT00243919|3227426|Superiority or Other|||||||0.001|||||||ANOVA|Test differences across the three groups in change of Berg Balance Score from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757021|NCT00243919|3227426|Superiority or Other|||||||0.06|||||||ANOVA|Test differences across the three groups in change of Berg Balance Score from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757022|NCT00243919|3227427|Superiority or Other|||||||0.04|||||||ANOVA|Test differences across the three groups in change of FM-LE from baseline to 6-month post stroke.||6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757023|NCT00243919|3227427|Superiority or Other|||||||0.13|||||||ANOVA|Test differences across the three groups in change of FM-LE from baseline to 12-month post stroke.||12 month primary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757024|NCT00243919|3227428|Superiority or Other||||||<|0.0001|||||||ANOVA|Test differences across the three groups in change of SIS Mobility from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757025|NCT00243919|3227428|Superiority or Other||||||<|0.69|||||||ANOVA|Test differences across the three groups in change of SIS Mobility from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757026|NCT00243919|3227429|Superiority or Other|||||||0.03|||||||ANOVA|Test differences across the three groups in change of SIS ADL/iADL from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757027|NCT00243919|3227429|Superiority or Other|||||||0.07|||||||ANOVA|Test differences across the three groups in change of SIS ADL/iADL from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757028|NCT00243919|3227430|Superiority or Other|||||||0.06|||||||ANOVA|Test differences across the three groups in change of SIS Participation from baseline to 6-month post stroke.||6 month secondary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757029|NCT00243919|3227430|Superiority or Other|||||||0.48|||||||ANOVA|Test differences across the three groups in change of SIS Participation from baseline to 12-month post stroke.||12 month primary outcome. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757030|NCT00243919|3227431|Superiority or Other|||||||0.04|||||||Kruskal-Wallis|Test differences across the three groups in change of number of steps from baseline to 6-month post stroke.||6 month secondary analysis. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.|
1757031|NCT00243919|3227431|Superiority or Other|||||||0.1|||||||Kruskal-Wallis|Test differences across the three groups in change of number of steps from baseline to 12-month post stroke.||12 month primary outcome. The Kruskal-Wallis procedure was used to assess differences across the three groups in number of steps taken in the community. Wilcoxon signed rank tests were used to compare within-group improvements.|
1757032|NCT00243919|3227432|Superiority or Other||||||<|0.001|||||||ANOVA|Test differences across the three groups in change of 6 minute walking distance from baseline to 6-month post stroke.||6 month secondary analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757033|NCT00243919|3227432|Superiority or Other||||||<|0.45||||||Test differences across the three groups in change of 6 minute walking distance from baseline to 12-month post stroke.|ANOVA|||Primary 12 month analysis. Paired t-tests were used to compare within-group improvements and ANOVA to assess differences across the three groups followed with pairwise comparisons.|
1757034|NCT00243919|3227433|Superiority or Other||Mean Difference (Final Values)|0.1|||<|0.0001|2-Sided|95.0|0.05|0.14||Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p<0.0014.|t-test, 2 sided|||6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between HEP and late-LTP.|
1757035|NCT00243919|3227433|Superiority or Other||Mean Difference (Final Values)|0.12|||<|0.0001|2-Sided|95.0|0.08|0.16||Bonferroni adjustment for multiple testing was used in the pair-wise comparisons of the secondary outcomes. A difference is claimed to be statistically significant when p<0.0014.|t-test, 2 sided|||6 month secondary analysis. Following the overall ANOVA test, pairwise comparison was conducted to assess differences in walking speed changes between early-LTP and late-LTP.|
1757062|NCT00242710|3227530|Superiority or Other||LS Mean Difference|1.94|||<|0.001|2-Sided|95.0|0.92|2.97|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.|
1757063|NCT00242710|3227530|Superiority or Other||LS Mean Difference|1.83|||<|0.001|2-Sided|95.0|0.8|2.87|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.|
1757036|NCT00243919|3227434|Superiority or Other||Odds Ratio (OR)|2.04||||0.007|2-Sided|95.0|1.22|3.42|||Regression, Logistic|Pairwise comparisons were conducted: HEP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.||Logistic regression was used to compare the proportion of participants who improved functional level of walking between HEP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).|
1757037|NCT00243919|3227434|Superiority or Other||Odds Ratio (OR)|1.94||||0.01|2-Sided|95.0|1.18|3.21|||Regression, Logistic|Pairwise comparisons were conducted: Early-LTP versus Late-LTP, which had received only usual care in the 2- to 6-month post-stroke period.||Logistic regression was used to compare the proportion of participants who improved functional level of walking between early-LTP and Late-LTP (Usual Care) adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).|
1757038|NCT00243919|3227435|Superiority or Other||Mean Difference (Final Values)|0.01||||0.242||95.0||||We did not formally conduct statistical inference on the timing effect because the first primary null hypotheses is accepted. The p-value provided is the smallest alpha level that one would claim significant difference between early- and late-LTP.|Regression, Linear||Even though there was no formal inference of timing effect, we still provided descriptive statistics for the 6-month and 12-month changes. In addition, paired t-tests were used to compare within-group improvements.|The second primary analysis assessed the timing effect and its interaction with initial severity of gait impairment on walking speed change from baseline to 1 year after stroke.|
1757039|NCT00243919|3227436|Superiority or Other||Odds Ratio (OR)|1.192||||0.501|2-Sided|95.0|0.715|1.985|||Regression, Logistic|||Logistic regression was used to compare the proportion of participants who improved functional level of walking between Late-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression).|
1757040|NCT00243919|3227436|Superiority or Other||Odds Ratio (OR)|0.831||||0.481|2-Sided|95.0|0.497|1.391||The trial tested the superiority of LTP delivered early or late, compared to HEP, using a two-sided significance level of 0.05. The study-wide error rate was controlled by applying the Hochberg step-up procedure to the two primary comparisons.|Regression, Logistic|||Logistic regression was used to compare the proportion of participants who improved functional level of walking between Early-LTP and HEP adjusting for pre-specified covariates (severity of impairment, clinical site, age, stroke type, side of hemiparesis and depression). Assuming that 30% of HEP participants would improve functional level of walking, we derived a sample size of 400 to detect a clinically relevant 20% effect size with 85% power, adjusting for an loss-to-follow-up rate of 15%.|
1757041|NCT00243386|3227467|Superiority or Other||||||<|0.0001|||||||Wilcoxon Signed-Rank Test||||
1757042|NCT00243386|3227468|Superiority or Other|||||||0.0002||||||Due to multiple hypotheses testing results, adjusted alpha values are set to α*=0.005 (0.05/10). Adjustments take into account 10 hypotheses tests between On-Demand and any Prophylaxis. Statistically significant results are considered p-values < α*|Wilcoxon signed-rank test||||
1757043|NCT00243386|3227469|Superiority or Other|||||||0.0007||||||Due to multiple hypotheses testing results, adjusted alpha values are set to α*=0.005 (0.05/10). Adjustments take into account 10 hypotheses tests between On-Demand and any Prophylaxis. Statistically significant results are considered p-values < α*|Wilcoxon signed-rank test||||
1757044|NCT00243386|3227470|Superiority or Other|||||||0.1467|||||||Wilcoxon-Rank Sum (Mann-Whitney)||||
1757045|NCT00243386|3227491|Superiority or Other|||||||0.4924|||||||Wilcoxon-Rank Sum (Mann-Whitney)||||
1757046|NCT00243386|3227492|Superiority or Other||||||<|0.0001||||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-test||||
1757047|NCT00243386|3227493|Superiority or Other||||||<|0.0001||||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-test||||
1757048|NCT00243386|3227494|Superiority or Other||||||<|0.0001||||||2-sided paired T-tests were done comparing transformed annualized bleeding rates between On-Demand and Prophylaxis regimens.|Paired t-Test||||
1757049|NCT00243386|3227495|Superiority or Other|||||||0.6016|||||||t-test, 2 sided|||"A t-test was used to compare the means of the transformed data. The null-hypothesis tested was H0: X'A(PK-driven prophylaxis) - X'B (standard prophylaxis) = 0 (i.e., no difference for treatment under the 2 prophylactic regimens.~X' = (ABR+0.5)^(1/2)"|
1757050|NCT00243269|3227498|Superiority or Other|||||||0.84|||||||ANOVA|||ANOVA to compare means of the four groups was used.|
1757051|NCT00243269|3227499|Superiority or Other|||||||0.932|||||||ANOVA|||The primary analyses consisted of calculating means and standard deviations on nausea for the four study arms to generate an effect size estimate for a later R01. We also planned to use a 2 x 2 (i.e., two levels of expectancy CDs and two levels of expectancy handouts) full factorial analysis of variance (ANOVA) to examine the efficacy of these two methods of expectancy enhancement in reducing Average Nausea as well as any interaction effects.|
1757052|NCT00243152|3227502|Superiority||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the unaffected side.|
1757053|NCT00243152|3227502|Superiority||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the affected side.|
1757054|NCT00243152|3227502|Superiority||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the unaffected side.|
1757055|NCT00243152|3227502|Superiority||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the affected side.|
1757056|NCT00243152|3227502|Superiority||||||>|0.05|||||||t-test, 2 sided|||VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for heat applied to the unaffected side.|
1757057|NCT00243152|3227502|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Visual analog scale (VAS) ratings in the scanner. Measures of pain ratings to evoked stimuli during scanning for heat applied to the affected side.|
1757058|NCT00243022|3227527|Superiority or Other|||||||0.8|||||||t-test, 2 sided||||
1757059|NCT00243022|3227528|Superiority or Other|||||||0.12|||||||t-test, 2 sided||||
1757060|NCT00243022|3227529|Superiority or Other|||||||0.9|||||||t-test, 2 sided||||
1757064|NCT00242710|3227531|Superiority or Other||LS Mean Difference|4.68|||<|0.001|2-Sided|95.0|3.13|6.23|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.|
1757065|NCT00242710|3227531|Superiority or Other||LS Mean Difference|3.14|||<|0.001|2-Sided|95.0|1.83|4.46|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.|
1757066|NCT00242710|3227531|Superiority or Other||LS Mean Difference|3.25|||<|0.001|2-Sided|95.0|1.92|4.58|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.|
1757067|NCT00242710|3227533|Superiority or Other|||||||0.029|||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.|
1757068|NCT00242710|3227533|Superiority or Other|||||||0.007|||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.|
1757069|NCT00242710|3227533|Superiority or Other|||||||0.062|||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.|
1757070|NCT00242710|3227533|Superiority or Other|||||||0.008|||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.|
1757071|NCT00242710|3227533|Superiority or Other|||||||0.005|||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.|
1757072|NCT00242710|3227533|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.|
1757073|NCT00242710|3227533|Superiority or Other||||||<|0.008|||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.|
1757074|NCT00242710|3227533|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.|
1757075|NCT00242710|3227533|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.|
1757076|NCT00242710|3227533|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.|
1757077|NCT00242710|3227533|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.|
1757078|NCT00242710|3227533|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.|
1757079|NCT00242710|3227533|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.|
1757080|NCT00242710|3227533|Superiority or Other||||||<|0.554|||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.|
1757081|NCT00242710|3227533|Superiority or Other||||||<|0.758|||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.|
1757082|NCT00242710|3227533|Superiority or Other||||||<|0.227|||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.|
1757083|NCT00242710|3227533|Superiority or Other||||||<|1|||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.|
1757084|NCT00242710|3227533|Superiority or Other||||||<|1|||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.|
1757085|NCT00242710|3227533|Superiority or Other||||||<|0.437|||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.|
1757086|NCT00242710|3227533|Superiority or Other||||||<|0.689|||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.|
1757087|NCT00242710|3227533|Superiority or Other||||||<|0.281|||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.|
1757088|NCT00242710|3227533|Superiority or Other||||||<|0.669|||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.|
1757089|NCT00242710|3227533|Superiority or Other||||||<|0.507|||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.|
1757090|NCT00242710|3227533|Superiority or Other||||||<|0.448|||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.|
1757091|NCT00242710|3227533|Superiority or Other||||||<|0.777|||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.|
1757092|NCT00242710|3227533|Superiority or Other||||||<|0.813|||||||Fisher Exact|||Week 1-4: The Fisher exact test was used for comparisons between groups.|
1757093|NCT00242710|3227533|Superiority or Other||||||<|0.163|||||||Fisher Exact|||Week 49-52: The Fisher exact test was used for comparisons between groups.|
1757094|NCT00242710|3227533|Superiority or Other||||||<|0.489|||||||Fisher Exact|||Week 45-48: The Fisher exact test was used for comparisons between groups.|
1757095|NCT00242710|3227533|Superiority or Other||||||<|0.449|||||||Fisher Exact|||Week 41-44: The Fisher exact test was used for comparisons between groups.|
1757096|NCT00242710|3227533|Superiority or Other||||||<|0.736|||||||Fisher Exact|||Week 37-40: The Fisher exact test was used for comparisons between groups.|
1757097|NCT00242710|3227533|Superiority or Other||||||<|0.733|||||||Fisher Exact|||Week 33-36: The Fisher exact test was used for comparisons between groups.|
1757098|NCT00242710|3227533|Superiority or Other||||||<|1|||||||Fisher Exact|||Week 29-32: The Fisher exact test was used for comparisons between groups.|
1757099|NCT00242710|3227533|Superiority or Other||||||<|1|||||||Fisher Exact|||Week 25-28: The Fisher exact test was used for comparisons between groups.|
1757100|NCT00242710|3227533|Superiority or Other||||||<|0.218|||||||Fisher Exact|||Week 21-24: The Fisher exact test was used for comparisons between groups.|
1757101|NCT00242710|3227533|Superiority or Other||||||<|0.446|||||||Fisher Exact|||Week 17-20: The Fisher exact test was used for comparisons between groups.|
1757102|NCT00242710|3227533|Superiority or Other||||||<|0.516|||||||Fisher Exact|||Week 13-16: The Fisher exact test was used for comparisons between groups.|
1757103|NCT00242710|3227533|Superiority or Other||||||<|1|||||||Fisher Exact|||Week 9-12: The Fisher exact test was used for comparisons between groups.|
1757104|NCT00242710|3227533|Superiority or Other||||||<|0.534|||||||Fisher Exact|||Week 5-8: The Fisher exact test was used for comparisons between groups.|
1757157|NCT00241904|3227577|Superiority|||||||0.034|||||||General Linear Mixed Model||||
1757107|NCT00242710|3227534|Superiority or Other||LS Mean Difference|1.35||||0.27|2-Sided|95.0|-1.05|3.75|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757108|NCT00242710|3227534|Superiority or Other||LS Mean Difference|1.63||||0.175|2-Sided|95.0|-0.73|3.99|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757109|NCT00242710|3227534|Superiority or Other||LS Mean Difference|3.3||||0.004|2-Sided|95.0|1.05|5.54|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757110|NCT00242710|3227534|Superiority or Other||LS Mean Difference|3.75|||<|0.001|2-Sided|95.0|1.68|5.83|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757111|NCT00242710|3227534|Superiority or Other||LS Mean Difference|3.81|||<|0.001|2-Sided|95.0|1.55|6.07|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757112|NCT00242710|3227534|Superiority or Other||LS Mean Difference|3.52|||<|0.012|2-Sided|95.0|0.78|6.26|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757113|NCT00242710|3227534|Superiority or Other||LS Mean Difference|3.75|||<|0.008|2-Sided|95.0|0.96|6.54|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757114|NCT00242710|3227534|Superiority or Other||LS Mean Difference|2.61|||<|0.023|2-Sided|95.0|0.36|4.87|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757115|NCT00242710|3227534|Superiority or Other||LS Mean Difference|3.15|||<|0.004|2-Sided|95.0|1.01|5.3|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757116|NCT00242710|3227534|Superiority or Other||LS Mean Difference|3.45|||<|0.005|2-Sided|95.0|1.03|5.86|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757117|NCT00242710|3227534|Superiority or Other||LS Mean Difference|4.18|||<|0.001|2-Sided|95.0|1.79|6.58|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757118|NCT00242710|3227534|Superiority or Other||LS Mean Difference|2.61|||<|0.003|2-Sided|95.0|0.92|4.3|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757119|NCT00242710|3227534|Superiority or Other||LS Mean Difference|0.19|||<|0.911|2-Sided|95.0|-3.17|3.56|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757120|NCT00242710|3227534|Superiority or Other||LS Mean Difference|0.09|||<|0.931|2-Sided|95.0|-1.92|2.1|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757121|NCT00242710|3227534|Superiority or Other||LS Mean Difference|-0.3|||<|0.766|2-Sided|95.0|-2.27|1.67|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757122|NCT00242710|3227534|Superiority or Other||LS Mean Difference|-0.32|||<|0.739|2-Sided|95.0|-2.21|1.57|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757123|NCT00242710|3227534|Superiority or Other||LS Mean Difference|0.51|||<|0.564|2-Sided|95.0|-1.23|2.25|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757124|NCT00242710|3227534|Superiority or Other||LS Mean Difference|0.64|||<|0.505|2-Sided|95.0|-1.25|2.53|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757125|NCT00242710|3227534|Superiority or Other||LS Mean Difference|-0.08|||<|0.947|2-Sided|95.0|-2.39|2.23|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757126|NCT00242710|3227534|Superiority or Other||LS Mean Difference|0.59|||<|0.625|2-Sided|95.0|-1.77|2.94|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757127|NCT00242710|3227534|Superiority or Other||LS Mean Difference|-0.04|||<|0.963|2-Sided|95.0|-1.94|1.85|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757128|NCT00242710|3227534|Superiority or Other||LS Mean Difference|0.1|||<|0.909|2-Sided|95.0|-1.7|1.91|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757129|NCT00242710|3227534|Superiority or Other||LS Mean Difference|-0.34|||<|0.744|2-Sided|95.0|-2.41|1.72|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757130|NCT00242710|3227534|Superiority or Other||LS Mean Difference|0.22|||<|0.834|2-Sided|95.0|-1.84|2.28|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757131|NCT00242710|3227534|Superiority or Other||LS Mean Difference|0.34|||<|0.654|2-Sided|95.0|-1.14|1.81|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757132|NCT00242710|3227534|Superiority or Other||LS Mean Difference|-0.41|||<|0.81|2-Sided|95.0|-3.78|2.96|||ANCOVA|||Week 49-52: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757133|NCT00242710|3227534|Superiority or Other||LS Mean Difference|0.51|||<|0.618|2-Sided|95.0|-1.5|2.52|||ANCOVA|||Week 45-48: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757134|NCT00242710|3227534|Superiority or Other||LS Mean Difference|1.13|||<|0.26|2-Sided|95.0|-0.84|3.11|||ANCOVA|||Week 41-44: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757135|NCT00242710|3227534|Superiority or Other||LS Mean Difference|1.04|||<|0.279|2-Sided|95.0|-0.85|2.92|||ANCOVA|||Week 37-40: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757136|NCT00242710|3227534|Superiority or Other||LS Mean Difference|1.55|||<|0.08|2-Sided|95.0|-0.18|3.29|||ANCOVA|||Week 33-36: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757137|NCT00242710|3227534|Superiority or Other||LS Mean Difference|1.62|||<|0.092|2-Sided|95.0|-0.27|3.51|||ANCOVA|||Week 29-32: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757138|NCT00242710|3227534|Superiority or Other||LS Mean Difference|1.22|||<|0.299|2-Sided|95.0|-1.08|3.52|||ANCOVA|||Week 25-28: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757139|NCT00242710|3227534|Superiority or Other||LS Mean Difference|1.23|||<|0.305|2-Sided|95.0|-1.12|3.57|||ANCOVA|||Week 21-24: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757140|NCT00242710|3227534|Superiority or Other||LS Mean Difference|0.5|||<|0.605|2-Sided|95.0|-1.39|2.39|||ANCOVA|||Week 17-20: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757141|NCT00242710|3227534|Superiority or Other||LS Mean Difference|1.09|||<|0.233|2-Sided|95.0|-0.71|2.9|||ANCOVA|||Week 13-16: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757142|NCT00242710|3227534|Superiority or Other||LS Mean Difference|0.65|||<|0.539|2-Sided|95.0|-1.41|2.71|||ANCOVA|||Week 9-12: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757143|NCT00242710|3227534|Superiority or Other||LS Mean Difference|0.35|||<|0.738|2-Sided|95.0|-1.7|2.4|||ANCOVA|||Week 5-8: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757144|NCT00242710|3227534|Superiority or Other||LS Mean Difference|0.66|||<|0.373|2-Sided|95.0|-0.8|2.12|||ANCOVA|||Week 1-4: An ANCOVA model was used with treatment, center as factors, and baseline as the covariate.|
1757145|NCT00242710|3227535|Superiority or Other||LS Mean Difference|2.46|||<|0.001|2-Sided|95.0|1.69|3.23|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.|
1757146|NCT00242710|3227535|Superiority or Other||LS Mean Difference|1.82|||<|0.001|2-Sided|95.0|1.19|2.46|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.|
1757147|NCT00242710|3227535|Superiority or Other||LS Mean Difference|1.61|||<|0.001|2-Sided|95.0|0.97|2.24|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.|
1757148|NCT00242710|3227537|Superiority or Other||LS Mean Difference|3.78|||<|0.001|2-Sided|95.0|2.81|4.76|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.|
1757149|NCT00242710|3227537|Superiority or Other||LS Mean Difference|2.36|||<|0.001|2-Sided|95.0|1.56|3.17|||ANCOVA|||An ANCOVA model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.|
1757150|NCT00242710|3227537|Superiority or Other||Least Squares (LS) Mean Difference|2.37|||<|0.001|2-Sided|95.0|1.56|3.18|||ANCOVA|||An analysis of covariance (ANCOVA) model was used with treatment and center as main effects and baseline BMD and years since menopause as covariates.|
1757151|NCT00242385|3227569|Non-Inferiority or Equivalence (legacy)|To establish bioequivalence in AUC 0-infinity divided by the dose administered with a type I error of 5% the calculated two-sided 90% confidence interval were to be contained completely in the margins of equivalence defined as 80% to 125%.|Ratio of Geometric Means|0.934|||||2-Sided|90.0|0.855|1.021|||||||
1757152|NCT00242385|3227570|Non-Inferiority or Equivalence (legacy)|To establish bioequivalence in AUC 0-35d divided by the dose administered with a type I error of 5% the calculated two-sided 90% confidence interval were to be contained completely in the margins of equivalence defined as 80% to 125%.|Ratio of Geometric Means|0.928|||||2-Sided|90.0|0.858|1.002|||||||
1757153|NCT00241969|3227573|Superiority|All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of HAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates.|maximum likelihood|0.14||||0.049|2-Sided|95.0|0.001|0.27|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ and HAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates. Group main effects on these change scores in the presence of covariates were examined to determine the efficacy of the behavioral and nutrition treatment.
1757154|NCT00241969|3227574|Superiority|All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates.|maximum likelihood|0.09||||0.25|2-Sided|95.0|-0.06|0.24|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Analyses of WAZ change scores were carried out within the PROC GLM procedure (SAS Institute Inc.) using an analysis of covariance model with sex, Pseudomonas aeruginosa status at baseline, treatment modality, and baseline value of the corresponding outcome variable as covariates. Group main effects on these change scores in the presence of covariates were examined to determine the efficacy of the behavioral and nutrition treatment.
1757155|NCT00241969|3227575|Superiority|Some data were missing for energy intake (n=3 baseline, n=13 post-treatment), thus the PROC MIXED procedure (SAS) with maximum likelihood estimation was used to analyze this outcome with time as a repeated measure factor.|maximum likelihood estimation|431.0|||<|0.001|2-Sided|95.0|282.0|581.0|||ANCOVA||||All analyses were performed on the full intention-to-treat sample (defined a priori as attending the first treatment session). Some data were missing for energy intake (N = 3 baseline; 13 post treatment), and thus the PROC MIXED procedure (SAS) with maximum likelihood estimation was used to analyze this outcome with time as a repeated measures factor, no group main effect at baseline for energy intake, and sex, baseline Pseudomonas aeruginosa status, and treatment modality as covariates in the statistical model. This model is similar to an analysis of covariance model with baseline energy intake included as an additional covariate, but the PROC MIXED model employs maximum likelihood estimation and consequently allows for data to be missing at random. The test of the time by group interaction within this PROC MIXED model indicated whether the behavioral and nutrition treatment was efficacious relative to our control treatment.
1757156|NCT00241904|3227576|Superiority||||||<|0.001|||||||General Linear Mixed Model||||
1757160|NCT00241839|3227580|Superiority or Other||Median Difference (Net)|2.15|Standard Error of the Mean|0.22|<|0.001|2-Sided|95.0|1.72|2.59|||t-test, 2 sided|Satterthwaite correction was used.|Allopurinol was associated with a significant decrease in uric acid over the treatment period as compared to placebo. The analysis is limited to those with both baseline and 8-10 week data on this variable.|We expected allopurinol to be associated with a decrease in uric acid.|
1757161|NCT00241839|3227581|Superiority or Other||Median Difference (Net)|-6.76|Standard Error of the Mean|2.11||0.002|2-Sided|95.0|-11.0|-2.6|||t-test, 2 sided|Sattherthwaite correction was used|The analysis is limited to those with both baseline and 8-10 week data on this variable. The 24 hour was in the opposite direction of the cuff.||
1757162|NCT00241839|3227582|Superiority or Other||Mean Difference (Net)|1.16|Standard Error of the Mean|1.59||0.47|2-Sided|95.0|-2.0|4.3||Positive numbers indicate a drop. We compared baseline minus value at treatment end for the two treatments.|t-test, 2 sided|Satterthwaite correction was used for potentially unequal variances.|The analysis is limited to those with both baseline and 8-10 week data on this variable.||
1757163|NCT00241839|3227583|Superiority or Other||Mean Difference (Net)|4.27|Standard Error of the Mean|2.24||0.059|2-Sided|95.0|-0.17|8.7|||t-test, 2 sided|Satterthwaite correction for possibly unequal variance was made|A positive value of the estimated value would favor the allopurinol arm. The analysis is limited to those with both baseline and 8-10 week data on this variable.|We compared the drop in baseline of diastolic BP for the two treatment groups Allopurinol vs. Placebo by a Satterthwaite corrected t-test.|
1757164|NCT00241631|3227603|Superiority||||||<|0.05||||||calculated|Mixed Models Analysis||||
1757165|NCT00241631|3227604|Superiority||||||<|0.05||||||calculated|Mixed Models Analysis||||
1757166|NCT00241631|3227605|Superiority|||||||0.012|||||||Mixed Models Analysis||||
1757167|NCT00241176|3227617|Superiority or Other||Mean Difference (Final Values)|0.004|||<|0.05||95.0|||||Wilcoxon (Mann-Whitney)||Mean (SD) CGI-Tic severity scores reduced significantly from (M=4.45 SD=0.52) (moderate-marked) at baseline to (M=3.18 SD =0.60) (mild) at end point ( p=0.004).|Mean scores baseline to endpoint|
1757168|NCT00241176|3227618|Superiority or Other||Mean Difference (Final Values)|0.003|||<|0.05|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)||YGTSS Global Severity score (M=61.8 SD=13.49) declined significantly to end point (M=33.7 SD=15.18; p=0.003).|Group 1 Baseline vs. Endpoint|
1757169|NCT00240994|3227619|Superiority or Other||Proportion with graft loss or death|0.057|||||2-Sided|95.0|0.007|0.192||||||The proportion of participants with graft loss or death within 12 months post kidney transplantation is descriptively summarized with a 95% confidence interval using an exact binomial method.|
1757170|NCT00240981|3227620|Superiority or Other||Mean Difference (Net)|0.09||||0.14|2-Sided|95.0|-0.03|0.209||Adjusted.|Regression, Linear||||
1757171|NCT00240981|3227620|Superiority or Other||Mean Difference (Net)|0.074||||0.24|2-Sided|95.0|-0.05|0.19||Unadjusted.|t-test, 2 sided||||
1757172|NCT00240981|3227621|Superiority or Other||Mean Difference (Net)|-2.0|||<|0.0001|2-Sided|95.0|-2.8|-1.2||6 Month Measures|t-test, 2 sided||||
1757173|NCT00240981|3227621|Superiority or Other||Mean Difference (Net)|-1.7|||<|0.002|2-Sided|95.0|-2.7|-0.6||3 Months Measures|t-test, 2 sided||||
1757174|NCT00240981|3227622|Superiority or Other||Mean Difference (Net)|1.5|||<|0.0001|2-Sided|95.0|0.4|2.2||Month 6 Measures|t-test, 2 sided||||
1757175|NCT00240981|3227622|Superiority or Other||Mean Difference (Net)|1.8|||<|0.2|2-Sided|95.0|1.2|2.5||Month 3 Measures|t-test, 2 sided||||
1757176|NCT00240981|3227624|Superiority or Other||Mean Difference (Net)|29.7||||0.05|2-Sided|95.0|0.2|59.3||Adjusted|Regression, Linear||||
1757177|NCT00240981|3227624|Superiority or Other||Mean Difference (Net)|30.2||||0.05|2-Sided|95.0|0.3|60.1||Unadjusted.|t-test, 2 sided||||
1757178|NCT00240981|3227625|Superiority or Other||Mean Difference (Net)|0.048||||0.27|2-Sided|95.0|-0.037|0.133||Adjusted|Regression, Linear||||
1757179|NCT00240981|3227625|Superiority or Other||Mean Difference (Net)|0.05||||0.26|2-Sided|95.0|-0.035|0.135||Unadjusted.|t-test, 2 sided||||
1757180|NCT00240981|3227626|Superiority or Other||Mean Difference (Net)|0.26||||0.71|2-Sided|95.0|-1.1|1.7||Adjusted.|Regression, Linear||||
1757181|NCT00240981|3227626|Superiority or Other||Mean Difference (Net)|0.27||||0.69|2-Sided|95.0|-1.1|1.7||Unadjusted|t-test, 2 sided||||
1757182|NCT00240981|3227627|Superiority or Other||Mean Difference (Net)|8.1||||0.37|2-Sided|95.0|-9.9|26.2||Adjusted.|Regression, Linear||||
1757183|NCT00240981|3227627|Superiority or Other||Mean Difference (Net)|8.7||||0.34|2-Sided|95.0|-9.2|26.7||Unadjusted|t-test, 2 sided||||
1757184|NCT00240981|3227628|Superiority or Other||Mean Difference (Net)|34.5||||0.002|2-Sided|95.0|13.1|56.2||Adjusted|Regression, Linear||||
1757185|NCT00240981|3227628|Superiority or Other||Mean Difference (Net)|34.5||||0.002|2-Sided|95.0|13.2|55.8||Unadjusted|t-test, 2 sided||||
1757186|NCT00240981|3227629|Superiority or Other||Mean Difference (Net)|129.4||||0.004|2-Sided|95.0|43.5|215.4||Adjusted analysis used multiple linear regression, with adjustment for baseline total score on the Short Physical Performance Battery, and self-report of limitations in mobility.|Regression, Linear||||
1757187|NCT00240981|3227629|Superiority or Other||Mean Difference (Net)|129.8||||0.003|2-Sided|95.0|43.9|215.6||The unadjusted analysis using two-sample Student's t-tests of equal change in the trial groups, allowing unequal variance.|t-test, 2 sided||||
1757188|NCT00240487|3227642|Non-Inferiority or Equivalence|The primary outcome variable is the mean PaO2/FiO2 in each group after 8 hours of study participation to determine whether timing of treatment with nitric oxide impacts outcome (immediate treatment versus delayed treatment).|||||>|0.05|||||||t-test, 2 sided|||Differences in mean PaO2/FiO2 ratios between the two groups will help to determine whether order of therapy (immediate treatment with nitric oxide versus delayed treatment with nitric oxide) impacts outcomes.|
1757189|NCT00239837|3227676|Superiority or Other||Wald χ2|7.14||||0.008|2-Sided||||||Regression, Logistic|Data analyzed using repeated logistic regression model (generalized estimating equations). Domain X EV Level X Group interaction tested.|We began the analyses with a full-factorial model regressing choice on domain (gain=1, loss=0), the EV of the risky choice relative to the safe option (EV; range = -.38 to +.38), and dummy-coded treatment groups (Control= -1, Intervention =1).||
1757361|NCT00234078|3228034|Superiority or Other|||||||0.421||||||p-value is adjusted for multiple comparisons|t-test, 2 sided||||
1757191|NCT00239681|3227688|Superiority or Other||Hazard Ratio (HR)|0.57||||0.018||95.0|0.35|0.91|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)||
1757192|NCT00239681|3227689|Superiority or Other||Hazard Ratio (HR)|1.27|||<|0.015||95.0|1.05|1.53|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)||
1757193|NCT00239681|3227690|Superiority or Other||Hazard Ratio (HR)|0.84|||<|0.172||95.0|0.65|1.08|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)||
1757194|NCT00239681|3227691|Superiority or Other||Hazard Ratio (HR)|0.8|||<|0.021||95.0|0.67|0.97|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)||
1757195|NCT00239681|3227692|Superiority or Other||Hazard Ratio (HR)|0.56|||<|0.0001||95.0|0.46|0.69|||Regression, Cox||The hazard ratio shows (Rosuvastatin hazard/Placebo hazard)||
1757196|NCT00239226|3227750|Superiority or Other||Slope|3.93||||0.047|||||||Log Rank||||
1757197|NCT00238615|3227754|Superiority or Other||probability of survival at 2 years|0.72|Standard Deviation|0.0|||2-Sided|95.0|0.36|0.9||||||2-year overall survival (OS) Our null hypothesis was a probability of survival at 2 years of 0.30. The study was powered at 80% (with α 5% two-tailed) to detect a probability of survival at 2 years of 0.55. This would require 30 patients assuming accrual over 2 years with 1 year of additional follow-up. The probability of survival at 2 years of 0.55 is based on previous studies of neoadjuvant approaches with reported 2 year survival in the 40-60% range.|
1757198|NCT00238238|3227778|Superiority or Other|||||||0.002|||||||Log Rank||||
1757199|NCT00238238|3227779|Superiority or Other|||||||0.29|||||||Fisher Exact||||
1757200|NCT00237718|3227803|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1757201|NCT00237718|3227804|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1757202|NCT00237692|3227805|Superiority or Other||Est. % Diff in Patient w/Controlled DBP|3.4|||||2-Sided|95.0|0.3|6.6|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management|
1757203|NCT00237692|3227805|Superiority or Other||Est. % Diff in Patient w/Controlled SBP|1.6|||||2-Sided|95.0|-3.3|6.6|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 4 - Combined Behaviorial and Med Management|
1757204|NCT00237692|3227805|Superiority or Other||Est. % Diff in Patient w/Controlled DBP|0.7|||||2-Sided|95.0|-2.6|4.0|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nuse Med Management|
1757205|NCT00237692|3227805|Superiority or Other||Est. % Diff in Patient w/Controlled SBP|0.4|||||2-Sided|95.0|-4.8|5.5|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 3 - Nurse Med Management.|
1757206|NCT00237692|3227805|Superiority or Other||Est. Dif in Patient w/Controlled DBP|0.5|||||2-Sided|95.0|-2.7|3.8|||||Diastolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in diastolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral|
1757207|NCT00237692|3227805|Superiority or Other||Est. % Diff in Patient w/Controlled SBP|2.0|||||2-Sided|95.0|-3.1|7.1|||||Systolic blood pressure estimates are based on the longitudinal data model with an unstructured covariance matrix. Negative differences reflect improvement compared to usual care, and positive differences reflect worsening compared to usual care.|Estimated differences in systolic blood pressure at 12months between Arm 1 - Control and Arm 2 - Nurse Behavioral|
1757208|NCT00237692|3227807|Superiority or Other||% Diff|9.8|||||2-Sided|95.0|-1.9|21.4||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral & Med Mgmt and Arm 1 - Control at 18 months.|
1757209|NCT00237692|3227807|Superiority or Other||% Diff|1.7|||||2-Sided|95.0|-10.3|13.8||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 18 months.|
1757210|NCT00237692|3227807|Superiority or Other||% Diff|-2.4|||||2-Sided|95.0|-14.6|9.7||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 18 months.|
1757211|NCT00237692|3227807|Superiority or Other||Est. % of Patients with controlled SBP|71.6|||||2-Sided|95.0|63.7|79.5|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 18 months|
1757212|NCT00237692|3227807|Superiority or Other||Est. % of Patients with controlled SBP|63.5|||||2-Sided|95.0|55.1|72.0|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 18 months.|
1757213|NCT00237692|3227807|Superiority or Other||Est. % of Patients with controlled SBP|59.4|||||2-Sided|95.0|50.8|67.9|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled BP at 18 months|
1757214|NCT00237692|3227807|Superiority or Other||Est. % of Patients with controlled SBP|61.8|||||2-Sided|95.0|53.0|70.6|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 18 months|
1757215|NCT00237692|3227808|Superiority or Other||% diff|8.6|||||2-Sided|95.0|-2.9|20.2||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 4 - Combined Behavioral & Med Mgmt and Arm 1 - Control at 12 months.|
1757216|NCT00237692|3227808|Superiority or Other||% Diff|13.5|||||2-Sided|95.0|2.4|24.6||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 3 - Nurse Med Management and Arm 1 - Control at 12 months.|
1757217|NCT00237692|3227808|Superiority or Other||% Diff|13.2|||||2-Sided|95.0|2.0|24.4||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 12 months.|
1757218|NCT00237692|3227808|Superiority or Other||Est. % of Patients with controlled SBP|68.6|||||2-Sided|95.0|60.5|76.6|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 12 months.|
1757219|NCT00237692|3227808|Superiority or Other||Est. % of Patients with controlled SBP|73.4|||||2-Sided|95.0|66.1|80.7|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months.|
1757220|NCT00237692|3227808|Superiority or Other||Est. % of Patients with controlled SBP|73.1|||||2-Sided|95.0|65.6|80.7|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months|
1757221|NCT00237692|3227808|Superiority or Other||Est. % of Patients with controlled SBP|59.9|||||2-Sided|95.0|51.4|68.3|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 12 months.|
1757222|NCT00237692|3227809|Superiority or Other||% Diff|5.7|||||2-Sided|95.0|-6.0|17.6||||||Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Combined Behavioral & Med Mgmt and Arm 1 - Control at 6months.|
1757223|NCT00237692|3227809|Superiority or Other||% Diff|6.9|||||2-Sided|95.0|-4.7|18.7|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Med Management and Arm 1 - Control at 6months.|
1757224|NCT00237692|3227809|Superiority or Other||% diff|2.9|||||2-Sided|95.0|-9.0|14.9|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated Difference in Percentage of Patients with Controlled Systolic Blood pressure between Intervention Arm 2 - Nurse Behavioral and Arm 1 - Control at 6months.|
1757225|NCT00237692|3227809|Superiority or Other||Est. % of Patients with controlled SBP|63.8|||||2-Sided|95.0|55.6|72.0|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.|
1757226|NCT00237692|3227809|Superiority or Other||Est. % of Patients with controlled SBP|65.0|||||2-Sided|95.0|56.9|73.1|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.|
1757227|NCT00237692|3227809|Superiority or Other||Est. % of Patients with controlled SBP|60.9|||||2-Sided|95.0|52.5|69.3|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled systolic BP at 6 months.|
1757228|NCT00237692|3227809|Superiority or Other||Est. % of Patients with controlled SBP|58.0|||||2-Sided|95.0|49.3|66.7|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at 6 months.|
1757229|NCT00237692|3227810|Superiority or Other||Est. % of Patients with controlled SBP|59.8|||||2-Sided|95.0|55.6|63.9|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline|
1757230|NCT00237692|3227810|Superiority or Other||Est. % of patinets with controlled SBP|59.8|||||2-Sided|95.0|55.6|63.9|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled BP at Baseline|
1757231|NCT00237692|3227810|Superiority or Other||Est. % of patients with controled SBP|59.8|||||2-Sided|95.0|55.7|64.0|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline|
1757232|NCT00237692|3227810|Superiority or Other||Est. % of Patients with controlled SBP|59.8|||||2-Sided|95.0|55.7|63.9|||||Joint National Committee 7 blood pressure control: < 140/90 mmHg for non-diabetics; <130/80 mmHg for diabetics|Estimated % of participants with controlled Systolic BP at Baseline|
1757233|NCT00237666|3227817|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1757234|NCT00237042|3227843|Superiority or Other|||||||0.016|||||||Regression, Logistic|Adjusted for baseline value of the outcome variable|||
1757235|NCT00237042|3227844|Superiority or Other|||||||0.003|||||||Regression, Linear|Group means compared with linear regression adjusted for baseline values. Adjusted difference: -1.0 between SMT and COCT, -1.0 between TSMT and COCT.||The null hypothesis was that mean characteristic pain intensity at 12-month follow up is equal across the three groups.|
1757236|NCT00237042|3227845|Superiority or Other|||||||0.27|||||||Regression, Logistic|Adjusted for baseline value of the outcome variable|||
1757237|NCT00237042|3227846|Superiority or Other|||||||0.19|||||||Regression, Linear|Linear regression was used to compare group means at follow up, adjusted for baseline values of the outcome variable.||The null hypothesis was that mean characteristic pain intensity at 6-month follow up is equal across the three groups.|
1757238|NCT00236899|3227859|Superiority or Other|||||||0.476||||||This is the p-value for Treatment Drug (Docetaxel and Gemcitabine 3 Weekly + Docetaxel and Gemcitabine Weekly vs Paclitaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact||||
1757239|NCT00236899|3227859|Superiority or Other|||||||0.293||||||This is the p-value for Treatment Schedule (Docetaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine 3 Weekly) and Treatment Drug (Docetaxel and Gemcitabine Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact||||
1757240|NCT00236899|3227860|Superiority or Other|||||||0.47||||||This is the p-value for Treatment Drug (Docetaxel and Gemcitabine 3 Weekly + Docetaxel and Gemcitabine Weekly vs Paclitaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact||||
1757362|NCT00234078|3228034|Superiority or Other|||||||0.02||||||p-value is adjusted for multiple comparisons|t-test, 2 sided||||
1757241|NCT00236899|3227860|Superiority or Other|||||||0.142||||||This is the p-value for Treatment Schedule (Docetaxel and Gemcitabine 3 Weekly + Paclitaxel and Gemcitabine 3 Weekly) and Treatment Drug (Docetaxel and Gemcitabine Weekly + Paclitaxel and Gemcitabine Weekly).|Fisher Exact||||
1757242|NCT00236899|3227862|Superiority or Other||Odds Ratio (OR)|0.818||||0.4567|2-Sided|95.0|0.482|1.389|||Regression, Logistic||||
1757243|NCT00236899|3227863|Superiority or Other||Hazard Ratio (HR)|1.23||||0.15|2-Sided|95.0|0.93|1.62|||Regression, Cox||||
1757244|NCT00236899|3227864|Superiority or Other||Odds Ratio (OR)|0.442||||0.0028|2-Sided|95.0|0.259|0.754|||Regression, Logistic||||
1757245|NCT00236899|3227865|Superiority or Other||Hazard Ratio (HR)|1.01||||0.976|2-Sided|95.0|0.71|1.42|||Regression, Cox||||
1757246|NCT00236899|3227866|Superiority or Other||Hazard Ratio (HR)|0.98||||0.885|2-Sided|95.0|0.69|1.37|||Regression, Cox||||
1757247|NCT00236899|3227867|Superiority or Other||Hazard Ratio (HR)|1.14||||0.345||95.0|0.87|1.5|||Regression, Cox||||
1757248|NCT00236184|3227873|Superiority or Other||||||<|0.001|||||||Chi-squared, Corrected||||
1757249|NCT00236080|3227878|Non-Inferiority or Equivalence|Using the adjusted p value from Tukey’s least significant difference (LSD) test for armodafinil at 200 mg/day. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients.||||||0.0945||||||The p-value of Overall Treatment to Placebo|ANCOVA|||Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint .|
1757250|NCT00236080|3227879|Non-Inferiority or Equivalence|Number of participants analyzed was determined by those participants who had at least 1 postbaseline efficacy assessment. Sample size requirements were not based on statistical considerations. There were 20 patients in each of the 5 treatment groups, for a total of 100 patients. It is expected that the sample size will provide sufficient information for describing the specified evaluations.||||||0.1236||||||The p-value of Overall Treatment to Placebo|ANCOVA|This analysis adjusted for the difference among the treatment groups at baseline.||Sample size requirements were not based on statistical considerations. The null hypothesis was Ho: μplacebo = μ150 = μ200 = μ250 = μprovigil versus Ha: at least 2 of the means are different, where μ represented the change from baseline to the endpoint.|
1757251|NCT00235755|3227922|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1757252|NCT00235755|3227922|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1757253|NCT00235755|3227923|Superiority or Other|||||||0.007||||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA||||
1757254|NCT00235755|3227923|Superiority or Other||||||<|0.001||||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA||||
1757255|NCT00235716|3227924|Superiority or Other||Hazard Ratio (HR)|0.94||||0.8|2-Sided|95.0|0.57|1.54||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for the vitamin E + memantine group relative to the placebo group.||
1757256|NCT00235716|3227924|Superiority or Other||Hazard Ratio (HR)|1.06||||0.47|2-Sided|95.0|0.91|1.24||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for the memantine group relative to the placebo group.||
1757257|NCT00235716|3227924|Superiority or Other||Hazard Ratio (HR)|0.87||||0.31|2-Sided|95.0|0.67|1.13||p-value is unadjusted for multiple comparisons|Log Rank||Hazard ratio is for vitamin E group relative to the placebo group.||
1757258|NCT00235716|3227925|Superiority or Other||Mean Difference (Net)|-2.17||||0.03|2-Sided|95.0|-3.71|-0.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757259|NCT00235716|3227925|Superiority or Other||Mean Difference (Net)|-0.52||||0.86|2-Sided|95.0|-2.07|1.02||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757260|NCT00235716|3227925|Superiority or Other||Mean Difference (Net)|1.65||||0.14|2-Sided|95.0|0.11|3.19||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757261|NCT00235716|3227925|Superiority or Other||Mean Difference (Net)|-0.14||||0.86|2-Sided|95.0|-1.7|1.42||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757262|NCT00235716|3227925|Superiority or Other||Mean Difference (Net)|0.38||||0.86|2-Sided|95.0|-1.18|1.94||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757363|NCT00234078|3228034|Superiority or Other|||||||0.084||||||p-value is adjusted for multiple comparisons|t-test, 2 sided||||
1757263|NCT00235716|3227925|Superiority or Other||Mean Difference (Net)|-1.79||||0.12|2-Sided|95.0|-3.35|-0.23||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757264|NCT00235716|3227926|Superiority or Other||Mean Difference (Net)|-1.08||||0.94|2-Sided|95.0|-3.14|0.99||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757265|NCT00235716|3227926|Superiority or Other||Mean Difference (Net)|-0.08||||0.94|2-Sided|95.0|-2.16|1.99||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757266|NCT00235716|3227926|Superiority or Other||Mean Difference (Net)|0.99||||0.94|2-Sided|95.0|-1.09|3.07||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757267|NCT00235716|3227926|Superiority or Other||Mean Difference (Net)|-0.47||||0.94|2-Sided|95.0|-2.57|1.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757268|NCT00235716|3227926|Superiority or Other||Mean Difference (Net)|-0.39||||0.94|2-Sided|95.0|-2.47|1.7||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757269|NCT00235716|3227926|Superiority or Other||Mean Difference (Net)|-1.46||||0.94|2-Sided|95.0|-3.55|0.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757270|NCT00235716|3227927|Superiority or Other||Mean Difference (Net)|-0.41||||0.84|2-Sided|95.0|-1.88|1.06||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757271|NCT00235716|3227927|Superiority or Other||Mean Difference (Net)|-0.26||||0.84|2-Sided|95.0|-1.72|1.21||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757272|NCT00235716|3227927|Superiority or Other||Mean Difference (Net)|0.15||||0.84|2-Sided|95.0|-1.32|1.63||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757273|NCT00235716|3227927|Superiority or Other||Mean Difference (Net)|-1.65||||0.14|2-Sided|95.0|-3.12|-0.17||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757274|NCT00235716|3227927|Superiority or Other||Mean Difference (Net)|-1.39||||0.25|2-Sided|95.0|-2.85|0.07||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757327|NCT00234533|3228006|Other||Mean difference|-164.79|Standard Error of the Mean|159.28|||2-Sided|95.0|-483.35|-153.77||||||The Bland and Altman method was used to compare the results of each of the three simultaneous random capillary and serum measurements were compared. The difference between the capillary blood spot method and the serum IGF-I measurements is presented|
1757275|NCT00235716|3227927|Superiority or Other||Mean Difference (Net)|-1.8||||0.1|2-Sided|95.0|-3.28|-0.33||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757276|NCT00235716|3227928|Superiority or Other||Mean Difference (Net)|0.08||||0.84|2-Sided|95.0|-0.65|0.8||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757277|NCT00235716|3227928|Superiority or Other||Mean Difference (Net)|0.25||||0.84|2-Sided|95.0|-0.47|0.98||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757278|NCT00235716|3227928|Superiority or Other||Mean Difference (Net)|0.17||||0.84||95.0|-0.56|0.9||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757279|NCT00235716|3227928|Superiority or Other||Mean Difference (Net)|0.37||||0.84|2-Sided|95.0|-0.36|1.1||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757280|NCT00235716|3227928|Superiority or Other||Mean Difference (Net)|0.12||||0.84|2-Sided|95.0|-0.61|0.84||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757281|NCT00235716|3227928|Superiority or Other||Mean Difference (Net)|0.19||||0.84|2-Sided|95.0|-0.54|0.92||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757282|NCT00235716|3227929|Superiority or Other|||||||0.69||||||p- value is unadjusted for multiple comparisons because its a 3 degrees of freedom test for any treatment group differences|Log Rank|3 degrees of freedom test|||
1757283|NCT00235716|3227930|Superiority or Other||Mean Difference (Net)|1.18||||0.6|2-Sided|95.0|-1.04|3.39||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757284|NCT00235716|3227930|Superiority or Other||Mean Difference (Net)|-0.22||||0.85|2-Sided|95.0|-2.44|2.01||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the memantine group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757285|NCT00235716|3227930|Superiority or Other||Mean Difference (Net)|-1.39||||0.6|2-Sided|95.0|-3.63|0.85||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the vitamin E group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757286|NCT00235716|3227930|Superiority or Other||Mean Difference (Net)|1.76||||0.49|2-Sided|95.0|-0.48|4.0||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E + memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757287|NCT00235716|3227930|Superiority or Other||Mean Difference (Net)|1.98||||0.4|2-Sided|95.0|-0.24|4.2||p-value is adjusted for 6 treatment group comparisons|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the memantine group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757364|NCT00234078|3228035|Superiority or Other|||||||0.601||||||versus placebo|t-test, 2 sided|a general linear model|||
1757288|NCT00235716|3227930|Superiority or Other||Mean Difference (Net)|3.15||||0.03|2-Sided|95.0|0.92|5.39||p-value adjusted for 6 treatment group comparisons.|Mixed Models Analysis|Mixed effects model assuming data missing at random, adjusted for medical center as a random effect and for the baseline outcome score.|Mean difference is the least squares mean changes from baseline for the vitamin E group minus the placebo group.|Longitudinal analysis to assess the average treatment effect over 48 months with visits at 6, 12, 18, 24, 30, 36, 42 and 48 months using all available data.|
1757289|NCT00235495|3227935|Superiority or Other (legacy)||Risk Ratio (RR)|1.1|||||2-Sided|95.0|0.74|1.63|||||||
1757290|NCT00235495|3227936|Superiority or Other (legacy)||Risk Ratio (RR)|1.05|||||2-Sided|95.0|0.68|1.61|||||||
1757291|NCT00235495|3227937|Superiority or Other (legacy)||Risk Ratio (RR)|1.14|||||2-Sided|95.0|0.68|2.01|||||||
1757292|NCT00235495|3227938|Superiority or Other (legacy)||Risk Ratio (RR)|2.42|||||2-Sided|95.0|1.02|5.78|||||||
1757293|NCT00235495|3227939|Superiority or Other (legacy)||Risk Ratio (RR)|2.58|||||2-Sided|95.0|1.09|6.12|||||||
1757294|NCT00235495|3227940|Superiority or Other (legacy)||Risk Ratio (RR)|10.8|||||2-Sided|95.0|4.37|26.72|||||||
1757295|NCT00235495|3227941|Superiority or Other (legacy)||Risk Ratio (RR)|1.69|||||2-Sided|95.0|0.98|2.94|||||||
1757296|NCT00235495|3227942|Superiority or Other (legacy)||Risk Ratio (RR)|1.16|||||2-Sided|95.0|0.39|3.41|||||||
1757297|NCT00235495|3227943|Superiority or Other (legacy)||Risk Ratio (RR)|1.01|||||2-Sided|95.0|0.47|2.15|||||||
1757298|NCT00235495|3227944|Superiority or Other (legacy)||Risk Ratio (RR)|1.18|||||2-Sided|95.0|0.79|1.76|||||||
1757299|NCT00235495|3227945|Superiority or Other (legacy)||Rank Sum|44853.5||||0.923||95.0|||||Wilcoxon rank sum test, normal approx||||
1757300|NCT00235495|3227946|Superiority or Other (legacy)||Rank Sum|73098.0||||0.913||95.0|||||Wilcoxon rank sum test, normal approx||||
1757301|NCT00235495|3227947|Superiority or Other (legacy)||Risk Ratio (RR)|0.93|||||2-Sided|99.0|0.84|1.02|||||||
1757302|NCT00235495|3227948|Superiority or Other (legacy)||Risk Ratio (RR)|0.99|||||2-Sided|99.0|0.84|1.17|||||||
1757303|NCT00235495|3227949|Superiority or Other (legacy)||Risk Ratio (RR)|0.95|||||2-Sided|99.0|0.83|1.1|||||||
1757304|NCT00235495|3227950|Superiority or Other (legacy)||Risk Ratio (RR)|0.98|||||2-Sided|99.0|0.87|1.11|||||||
1757305|NCT00235495|3227951|Superiority or Other (legacy)||Risk Ratio (RR)|0.99|||||2-Sided|99.0|0.85|1.13|||||||
1757306|NCT00235495|3227952|Superiority or Other (legacy)||Risk Ratio (RR)|1.03|||||2-Sided|99.0|0.82|1.28|||||||
1757307|NCT00235495|3227953|Superiority or Other (legacy)||Risk Ratio (RR)|0.88|||||2-Sided|99.0|0.71|1.1|||||||
1757308|NCT00235495|3227954|Superiority or Other (legacy)||Risk Ratio (RR)|0.99|||||2-Sided|99.0|0.66|1.49|||||||
1757309|NCT00235495|3227955|Superiority or Other (legacy)||Risk Ratio (RR)|0.93|||||2-Sided|99.0|0.8|1.09|||||||
1757310|NCT00235495|3227956|Superiority or Other (legacy)||Risk Ratio (RR)|0.96|||||2-Sided|95.0|0.84|1.1|||||Adjusted risk ratio greater than 1 indicates greater risk of good outcome in the Albumin treatment group, while adjusted risk ratio less than 1 indicates greater risk of good outcome in the Saline treatment group.|Test of null hypothesis (equal proportions of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin and Saline treatment arms) versus alternative hypothesis (greater proportion of subjects with NIHSS 0-1 or mRS 0-1 or both at 90 days post-randomization in Albumin treatment arm).|
1757311|NCT00235456|3227957|Superiority or Other|||||||0.09|||||||t-test, 2 sided||||
1757312|NCT00235456|3227958|Superiority or Other|||||||0.71|||||||t-test, 2 sided||||
1757313|NCT00235456|3227959|Superiority or Other|||||||0.57|||||||t-test, 2 sided||||
1757314|NCT00235456|3227960|Superiority or Other|||||||0.28|||||||t-test, 2 sided||||
1757315|NCT00235456|3227961|Superiority or Other|||||||0.54|||||||t-test, 2 sided||||
1757316|NCT00235456|3227962|Superiority or Other||Risk Ratio (RR)|0.61||||0.04|2-Sided|95.0|0.38|0.98|||Chi-squared||||
1757317|NCT00234832|3227989|Superiority or Other||Cox Proportional Hazard|0.988||||0.899|2-Sided|95.0|0.822|1.188|||Log Rank||||
1757318|NCT00234832|3227990|Superiority or Other||Cox Proportional Hazard|1.582||||0.343|2-Sided|95.0|0.613|4.081|||Log Rank||||
1757319|NCT00234832|3227991|Superiority or Other||Cox Proportional Hazard|1.355||||0.025|2-Sided|95.0|1.038|1.767|||Log Rank||||
1757320|NCT00234832|3227992|Superiority or Other||Cox Proportional Hazard|1.276||||0.022|2-Sided|95.0|1.036|1.571|||Log Rank||||
1757321|NCT00234832|3227993|Superiority or Other||Cox Proportional Hazard|1.097||||0.051|2-Sided|95.0|0.999|1.204|||Log Rank||||
1757322|NCT00234832|3227994|Superiority or Other||Cox Proportional Hazard|1.043||||0.543|2-Sided|95.0|0.91|1.196|||Log Rank||||
1757323|NCT00234832|3227995|Superiority or Other||Cox Proportional Hazard|1.182||||0.022|2-Sided|95.0|1.024|1.365|||Log Rank|||This analysis included only subjects with CV + DM in a comparison of sibutramine and placebo.|
1757324|NCT00234832|3227995|Superiority or Other||Cox Proportional Hazard|1.276||||0.149|2-Sided|95.0|0.916|1.776|||Log Rank|||This analysis included only subjects with CV only in a comparison of sibutramine and placebo.|
1757325|NCT00234832|3227995|Superiority or Other||Cox Proportional Hazard|1.01||||0.948|2-Sided|95.0|0.738|1.384|||Log Rank|||This analysis included only subjects with DM only in a comparison of sibutramine and placebo.|
1757326|NCT00234832|3227995|Superiority or Other||Cox Proportional Hazard|1.162||||0.015|2-Sided|95.0|1.029|1.311||No adjustment for multiple testing or interim analysis was performed. The primary outcome was tested at a 2-sided alpha level of 0.05.|Log Rank||The Cox model included factors for treatment, country, gender, and age (continuous) at Lead-in Period baseline. For the calculation of risk, the sibutramine arm is the numerator and the placebo arm is the denominator.|For the sample size calculation, a two-tailed alpha level of 0.05 was used along with power of 90%. The annual composite event rate in the placebo arm was assumed to be 7.0%. A sample of 3983 subjects in each of the 2 groups, corrected for a 30% noncompliance rate (15% in Year 1 and 6.3% in each year, Years 2 to 4), followed for at least 3 years was expected to have 90% power to detect a relative risk reduction of 15% with sibutramine relative to placebo.|
1757357|NCT00234104|3228032|Superiority or Other||Mean Difference (Final Values)|-1.09||||0.0074||95.0|||||t-test, 2 sided|Dunnett's test was used|||
1757328|NCT00234533|3228007|Other||F value|3.86|||||2-Sided|||||||||Analysis of the effect of the disease condition on the IGF-I value as measured by capillary blood spot method.|For the effect of the disease condition on the IGF-I levels; F value = 3.86 and the significance probability value, PR>F = 0.0511
1757329|NCT00234533|3228007|Other||F value|7.38|||||2-Sided|||||||||Analysis of the effect of the calculated age at enrolment on the IGF-I value as measured by capillary blood spot method.|For the effect of the calculated age at enrolment on the IGF-I levels; F value = 7.38 and the significance probability value, PR>F = 0.0073.
1757330|NCT00234533|3228007|Other||F value|3.65|||||2-Sided|||||||||Analysis of the time of the year on the IGF-I value as measured by capillary blood spot method.|For the effect of the time of the year on the IGF-I levels; F value = 3.65 and the significance probability value, PR>F = 0.0139.
1757331|NCT00234533|3228008|Other||F value|2.2|||||2-Sided|||||||||Analysis of the country cluster on the IGF-I value as measured by capillary blood spot method.|For the effect of the country cluster on the IGF-I levels; F value = 2.20 and the significance probability value, PR>F = 0.0701.
1757332|NCT00234533|3228008|Other||F value|10.73|||||2-Sided|||||||||Analysis of the disease condition (GHD versus TS) on the IGF-I value as measured by capillary blood spot method.|For the effect of the disease condition on the IGF-I levels; F value = 10.73 and the significance probability value, PR>F = 0.0012.
1757333|NCT00234533|3228009|Other||F value|68.35|||||2-Sided|||||||||Analysis of the effect of the patient's pubertal status (pubertal versus prepubertal) on the IGF-I value as measured by capillary blood spot method.|For the effect of the patient's pubertal status on the IGF-I levels; F value = 68.35 and the significance probability value, PR>F = <0.0001.
1757334|NCT00234533|3228009|Other||F value|83.97|||||2-Sided|||||||||Analysis of the effect of the patient's sex (male versus female) on the IGF-I value as measured by capillary blood spot method.|For the effect of the patient's sex on the IGF-I levels; F value = 83.97 and the significance probability value, PR>F = <0.0001.
1757335|NCT00234533|3228010|Other||F value|1.06|||||2-Sided|||||||||Analysis of the daily timing effect (morning versus evening) on the IGF-I value as measured by capillary blood spot method.|For the effect of the daily timing on the IGF-I levels; F value = 1.06 and the significance probability value, PR>F = 0.3035
1757336|NCT00234533|3228010|Other||Fisher's F statistic (F) value|1.79|||||2-Sided|||||||||Analysis of the weekly timing effect (Week 21 versus Week 22 versus Week 23) on the IGF-I value as measured by capillary blood spot method.|For the effect of the weekly timing on the IGF-I levels; F value = 1.79 and the significance probability value, PR>F = 0.1678.
1757337|NCT00234533|3228011|Other|An one-way ANOVA was used to calculate the between patient variation and within patient variation and then the ICC and its confidence limitations.|ICC|0.92|||||2-Sided|95.0|0.9|0.93|||||An ICC ≥ 0.8 was considered satisfactory and indicative that a single sample would be representative of the overall IGF-I status.|An ICC for the morning series (defined as 06:00 to 12:00) was determined for the overall ITT population to confirm whether only one measurement would be sufficient to accurately represent the IGF-I measurement over Weeks 21, 22 and 23. The ICC expresses the relative magnitude of the 2 components of the total variability, i.e. the biological variability and random error, in a series of measurements on different patients.|
1757338|NCT00234533|3228011|Other|An one-way Analysis of Covariance (ANOVA) was used to calculate the between patient variation and within patient variation and then the ICC and its confidence limitations.|ICC|0.9|||||2-Sided|95.0|0.88|0.92|||||An ICC ≥ 0.8 was considered satisfactory and indicative that a single sample would be representative of the overall IGF-I status.|An Intra-class Correlation Coefficient (ICC) for the evening series (defined as 12:00 to 24:00) was determined for the overall ITT population to confirm whether only one measurement would be sufficient to accurately represent the IGF-I measurement over Weeks 21, 22 and 23. The ICC expresses the relative magnitude of the 2 components of the total variability, i.e. the biological variability and random error, in a series of measurements on different patients.|
1757339|NCT00234286|3228016|Superiority or Other||Odds Ratio (OR)|2.45||||0.19|2-Sided|95.0|0.62|9.7|||Generalized Estimation Equations||||
1757340|NCT00234286|3228017|Superiority or Other||Odds Ratio (OR)|1.47||||0.003|2-Sided|95.0|1.15|1.88|||Generalized Estimating Equation||||
1757341|NCT00234286|3228018|Superiority or Other||Odds Ratio (OR)|1.64||||0.14|2-Sided|95.0|0.84|3.2|||Generalized Estimating Equations||||
1757342|NCT00234286|3228019|Superiority or Other||Odds Ratio (OR)|4.12||||0.007|2-Sided|95.0|1.51|11.28|||Generalized Estimating Equations||||
1757343|NCT00234286|3228020|Superiority or Other||Odds Ratio (OR)|2.77||||0.004|2-Sided|95.0|1.41|5.44|||Generalized Estimating Equation||||
1757344|NCT00234286|3228021|Superiority or Other||Odds Ratio (OR)|0.95||||0.76|2-Sided|95.0|0.7|1.3|||Generalized Estimating Equation||||
1757345|NCT00234286|3228022|Superiority or Other||Odds Ratio (OR)|1.39||||0.01|2-Sided|95.0|1.08|1.77|||Generalized Estimating Equation||||
1757346|NCT00234286|3228023|Superiority or Other||Odds Ratio (OR)|1.31||||0.36|2-Sided|95.0|0.73|2.35|||Generalized Estimating Equation||||
1757347|NCT00234286|3228024|Superiority or Other||Odds Ratio (OR)|1.98||||0.01|2-Sided|95.0|1.17|3.36|||Generalized Estimating Equation||||
1757348|NCT00234286|3228025|Superiority or Other||Odds Ratio (OR)|1.36||||0.09|2-Sided|95.0|0.95|1.96|||Generalized Estimating Equation||||
1757349|NCT00234286|3228026|Superiority or Other||Odds Ratio (OR)|1.04||||0.86|2-Sided|95.0|0.67|1.62|||Generalized Estimating Equation||||
1757350|NCT00234286|3228027|Superiority or Other||Odds Ratio (OR)|0.66||||0.15|2-Sided|95.0|0.38|1.16|||Generalized Estimating Equation||||
1757351|NCT00234286|3228028|Superiority or Other||Odds Ratio (OR)|0.71||||0.03|2-Sided|95.0|0.53|0.96|||Generalized Estimating Equations||||
1757352|NCT00234286|3228029|Superiority or Other||Odds Ratio (OR)|0.92||||0.69|2-Sided|95.0|0.59|1.42|||Generalized Estimating Equation||||
1757353|NCT00234286|3228030|Superiority or Other||Odds Ratio (OR)|1.36||||0.09|2-Sided|95.0|0.95|1.96|||Generalized Estimating Equation||||
1757354|NCT00234286|3228031|Superiority or Other||Odds Ratio (OR)|1.39||||0.009|2-Sided|95.0|1.09|1.76|||Generalized Estimating Equation||||
1757355|NCT00234104|3228032|Superiority or Other||Mean Difference (Final Values)|-1.32||||0.001||95.0|||||t-test, 2 sided|Dunnett's test was used|||
1757356|NCT00234104|3228032|Superiority or Other||Mean Difference (Final Values)|-0.82||||0.0459||95.0|||||t-test, 2 sided|Dunnett's test was used|||
1757365|NCT00234078|3228036|Superiority or Other|||||||0.385||||||versus placebo|t-test, 2 sided|a general linear model|||
1757366|NCT00234065|3228037|Superiority or Other||Hazard Ratio (HR)|0.458||||0.0004|2-Sided|95.0|0.296|0.711|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.|
1757367|NCT00234065|3228038|Superiority or Other||Hazard Ratio (HR)|0.799||||0.0437|2-Sided|95.0|0.643|0.994|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.|
1757368|NCT00234065|3228039|Superiority or Other||Hazard Ratio (HR)|1.072||||0.86|2-Sided|95.0|0.497|2.313|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.|
1757369|NCT00234065|3228040|Superiority or Other||Hazard Ratio (HR)|0.898||||0.4582|2-Sided|95.0|0.675|1.194|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.|
1757370|NCT00234065|3228041|Superiority or Other||Hazard Ratio, log|0.88||||0.4189|2-Sided|95.0|0.645|1.2|||Log Rank|||Analyses were done using the full analysis set (FAS) of patients, as predetermined in the protocol. The full analysis set excluded patients who failed to satisfy inclusion criteria and those who violated exclusion criteria.|
1757371|NCT00234065|3228042|Non-Inferiority or Equivalence|If the upper 95% CI limit for the HR of cilostazol to aspirin was 1.33 (4/3) or lower , cilostazol would be non-inferior to aspirin.|Hazard Ratio, log|0.743||||0.0357|2-Sided|95.0|0.564|0.981||The log-rank test was used to verify the superiority of CLZ to ASA only if non-inferiority was verified. The adjusted significance level for the superiority test of the endpoint was set at 0.0471 (two-tailed) according to the O’Brien-Fleming method.|Log Rank|||Statistical Analysis 1 for Number of Patients With First Occurrence of Stroke|
1757372|NCT00233480|3228067|Superiority or Other (legacy)|||||||0.025|||||||paired t test||||
1757373|NCT00233064|3228107|Superiority or Other||Overall percentage of immune reactivity|0.3||||||95.0|0.0|1.5|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of <2-3% based on 95% confidence intervals [(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)].|
1757374|NCT00233064|3228107|Superiority or Other||Overall percentage of immune reactivity|0.5||||||95.0|0.0|2.9|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of <2-3% based on 95% confidence intervals [(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)].|
1757375|NCT00233064|3228107|Superiority or Other||Overall percentage of immune reactivity|0.0||||||95.0|0.0|1.9|||||The number and percentage of subjects with immune reactivity at Study Day 240-300 were constructed using the Clopper-Pearson Method.|The subject number of 200 per treatment group was derived to demonstrate a percentage of immune reactivity in either the liquid or lyophilized formulations of palivizumab of <2-3% based on 95% confidence intervals [(0%; 0.00, 1.83), (0.5%; 0.01, 2.75), (1%; 0.12, 3.57)].|
1757376|NCT00232739|3228121|Superiority or Other||Primary analysis posterior probability|0.9926|||||||||||||Secondary analysis for comparing Sirolimus stent with BMS1 and BMS2 signified that Sirolimus stent is superior to POBA, BMS1 and BMS2 in reducing the BAR risk.|Historical control groups consist of propensity-scored matched cohorts (100 patients each, based on Reference Vessel Diameter, lesion length, diabetes, left anterior artery diseased vessel, and gender) of plain old balloon angioplasty (POBA), first generation (Palmaz-Schatz) bare metal stent (BMS1), and BX VELOCITY bare metal stent (BMS2). Study showed the risk of 6-month in-lesion binary angiographic restenosis (BAR) was much lower for the 2.25 Sirolimus stent compared with POBA, BMS1 or BMS2.|
1757377|NCT00232596|3228140|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1757378|NCT00232596|3228141|Superiority or Other||||||<|0.001||||||Non-parametric rank analysis of covariance adjusted for baseline 28-seizure frequency and stratified by baseline seizure frequency category and region|Non-parametric rank ANCOVA||||
1757379|NCT00232180|3228168|Superiority or Other||Hazard Ratio (HR)|0.885||||0.6009|2-Sided|95.0|0.559|1.4||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757380|NCT00232180|3228169|Superiority or Other||Hazard Ratio (HR)|0.585||||0.0175|2-Sided|95.0|0.376|0.91||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757381|NCT00232180|3228170|Superiority or Other||Hazard Ratio (HR)|1.154||||0.8539|2-Sided|95.0|0.251|5.312||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757603|NCT00227903|3228418|Superiority or Other (legacy)||Odds Ratio (OR)|0.77||||0.5|2-Sided|95.0|0.32|1.84|||Regression, Logistic||||
1757604|NCT00227903|3228419|Superiority or Other (legacy)||Odds Ratio (OR)|1.21||||0.88|2-Sided|95.0|0.57|2.57|||Regression, Logistic||||
1757382|NCT00232180|3228171|Superiority or Other||Hazard Ratio (HR)|0.971||||0.9537|2-Sided|95.0|0.366|2.578||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757383|NCT00232180|3228172|Superiority or Other||Hazard Ratio (HR)|0.77||||0.2652|2-Sided|95.0|0.485|1.22||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757384|NCT00232180|3228173|Superiority or Other||Hazard Ratio (HR)|0.994||||0.9754|2-Sided|95.0|0.694|1.424||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757385|NCT00232180|3228174|Superiority or Other||Hazard Ratio (HR)|0.789||||0.4213|2-Sided|95.0|0.443|1.406||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757386|NCT00232180|3228175|Superiority or Other||Hazard Ratio (HR)|1.316||||0.2321|2-Sided|95.0|0.839|2.064||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757387|NCT00232180|3228176|Superiority or Other||Hazard Ratio (HR)|0.694|||<|0.0001|2-Sided|95.0|0.598|0.806||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757388|NCT00232180|3228177|Superiority or Other||Hazard Ratio (HR)|0.577|||<|0.0001|2-Sided|95.0|0.475|0.701||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757389|NCT00232180|3228178|Superiority or Other||Hazard Ratio (HR)|0.751|||<|0.0001|2-Sided|95.0|0.664|0.849||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757390|NCT00232180|3228179|Superiority or Other||Hazard Ratio (HR)|0.576|||<|0.0001|2-Sided|95.0|0.473|0.702||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757391|NCT00232180|3228180|Superiority or Other||Hazard Ratio (HR)|0.768|||<|0.0001|2-Sided|95.0|0.673|0.876||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757392|NCT00232180|3228181|Superiority or Other||Hazard Ratio (HR)|0.757||||0.012|2-Sided|95.0|0.609|0.941||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757408|NCT00232141|3228194|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.3||0.2202||95.0|-0.96|0.22||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2|
1757393|NCT00232180|3228182|Superiority or Other||Hazard Ratio (HR)|0.761||||0.0081|2-Sided|95.0|0.622|0.932||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757394|NCT00232180|3228183|Superiority or Other||Hazard Ratio (HR)|0.647|||<|0.0001|2-Sided|95.0|0.552|0.757||Statistically significant if p-value <0.01|Cox proportional hazard model|||The statistical analysis was only performed on the adjudicated endpoint data up to cut-off. Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, QRS complex and atrial fibrillation as covariates.|
1757395|NCT00232180|3228185|Superiority or Other||Hazard Ratio (HR)|0.63|||<|0.0001|2-Sided|95.0|0.535|0.741||Using an adaptation of Haybittle-Peto stopping criterion adjusting for two interim analyses, p-value for final primary analysis will be compared to alpha=0.049. No adjustment in alpha will be made on parameters/endpoints other than primary endpoint.|Cox proportional hazard model|||Cox proportional hazard model includes treatment as the major factor, adjusting for age, estimated glomerular filtration rate, left ventricular ejection fraction, body mass index, hemoglobin, heart rate, systolic blood pressure, diabetes, history of hypertension, prior myocardial infarction, baseline left bundle branch block, time from electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) and atrial fibrillation as covariates.|
1757396|NCT00232141|3228189|Superiority or Other|||||||0.6729||||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel||||
1757397|NCT00232141|3228190|Superiority or Other|||||||0.7136||||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel||||
1757398|NCT00232141|3228193|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.29||0.8926||95.0|-0.61|0.53||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint|
1757399|NCT00232141|3228193|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.3||0.9739||95.0|-0.59|0.61||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14|
1757400|NCT00232141|3228193|Superiority or Other||Mean Difference (Final Values)|-0.14|Standard Error of the Mean|0.29||0.6288||95.0|-0.72|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10|
1757401|NCT00232141|3228193|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.29||0.8809||95.0|-0.62|0.53||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6|
1757402|NCT00232141|3228193|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.33||0.8407||95.0|-0.71|0.58||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2|
1757403|NCT00232141|3228193|Superiority or Other||Mean Difference (Final Values)|-0.33|Standard Error of the Mean|0.27||0.2277||95.0|-0.86|0.21||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1|
1757404|NCT00232141|3228194|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.3||0.4406||95.0|-0.36|0.82||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint|
1757405|NCT00232141|3228194|Superiority or Other||Mean Difference (Final Values)|0.25|Standard Error of the Mean|0.32||0.4374||95.0|-0.38|0.88||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14|
1757406|NCT00232141|3228194|Superiority or Other||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.3||0.1872||95.0|-0.98|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10|
1757407|NCT00232141|3228194|Superiority or Other||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.29||0.1824||95.0|-0.95|0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6|
1757561|NCT00231153|3228277|Superiority or Other||Net percentage difference|11.4|||<|0.001||95.0|6.7|16.11|||Cochran-Mantel-Haenszel||||
1757409|NCT00232141|3228194|Superiority or Other||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|0.25||0.0073||95.0|-1.18|-0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1|
1757410|NCT00232141|3228195|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.26||0.9508||95.0|-0.52|0.49||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint|
1757411|NCT00232141|3228195|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.27||0.9428||95.0|-0.51|0.55||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14|
1757412|NCT00232141|3228195|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.26||0.7641||95.0|-0.43|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10|
1757413|NCT00232141|3228195|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.26||0.3669||95.0|-0.76|0.28||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6|
1757414|NCT00232141|3228195|Superiority or Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.3||0.6094||95.0|-0.73|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2|
1757415|NCT00232141|3228195|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.28||0.4991||95.0|-0.74|0.36||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1|
1757416|NCT00232141|3228196|Superiority or Other||Mean Difference (Final Values)|0.31|Standard Error of the Mean|0.28||0.2685||95.0|-0.24|0.87||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint|
1757417|NCT00232141|3228196|Superiority or Other||Mean Difference (Final Values)|0.49|Standard Error of the Mean|0.31||0.1188||95.0|-0.13|1.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14|
1757418|NCT00232141|3228196|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.28||0.6394||95.0|-0.67|0.41||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10|
1757419|NCT00232141|3228196|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.26||0.7527||95.0|-0.6|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6|
1757420|NCT00232141|3228196|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.28||0.6897||95.0|-0.65|0.43||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2|
1757421|NCT00232141|3228196|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.26||0.8727||95.0|-0.55|0.46||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1|
1757422|NCT00232141|3228197|Superiority or Other||Mean Difference (Final Values)|0.31|Standard Error of the Mean|0.29||0.2819||95.0|-0.25|0.87||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint|
1757423|NCT00232141|3228197|Superiority or Other||Mean Difference (Final Values)|0.45|Standard Error of the Mean|0.31||0.1467||95.0|-0.16|1.06||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14|
1757424|NCT00232141|3228197|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|0.28||0.4614||95.0|-0.34|0.75||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10|
1757562|NCT00231153|3228278|Superiority or Other||Net percentage difference|3.67||||0.002||95.0|1.4|5.93|||Cochran-Mantel-Haenszel||||
1757605|NCT00227903|3228420|Superiority or Other (legacy)||Odds Ratio (OR)|0.96||||0.88|2-Sided|95.0|0.34|2.72|||Regression, Logistic||||
1757425|NCT00232141|3228197|Superiority or Other||Mean Difference (Final Values)|-0.11|Standard Error of the Mean|0.29||0.6931||95.0|-0.68|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6|
1757426|NCT00232141|3228197|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.3||0.9875||95.0|-0.58|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2|
1757427|NCT00232141|3228197|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.28||0.5493||95.0|-0.73|0.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1|
1757428|NCT00232141|3228198|Superiority or Other||Mean Difference (Final Values)|0.16|Standard Error of the Mean|0.28||0.5766||95.0|-0.4|0.71||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint|
1757429|NCT00232141|3228198|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.3||0.4286||95.0|-0.35|0.83||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14|
1757430|NCT00232141|3228198|Superiority or Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.28||0.5842||95.0|-0.7|0.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10|
1757431|NCT00232141|3228198|Superiority or Other||Mean Difference (Final Values)|-0.18|Standard Error of the Mean|0.28||0.508||95.0|-0.73|0.36||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6|
1757432|NCT00232141|3228198|Superiority or Other||Mean Difference (Final Values)|-0.16|Standard Error of the Mean|-0.31||0.5953||95.0|-0.77|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2|
1757433|NCT00232141|3228198|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.28||0.1863||95.0|-0.94|0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1|
1757434|NCT00232141|3228199|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.28||0.7972||95.0|-0.48|0.62||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint|
1757435|NCT00232141|3228199|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|0.3||0.3086||95.0|-0.28|0.89||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14|
1757436|NCT00232141|3228199|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.27||0.8319||95.0|-0.58|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10|
1757437|NCT00232141|3228199|Superiority or Other||Mean Difference (Final Values)|-0.12|Standard Error of the Mean|0.27||0.6563||95.0|-0.64|0.4||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6|
1757438|NCT00232141|3228199|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.26||0.7607||95.0|-0.6|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2|
1757439|NCT00232141|3228199|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.26||0.2352||95.0|-0.82|0.2||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1|
1757440|NCT00232141|3228200|Superiority or Other||Mean Difference (Final Values)|0.31|Standard Error of the Mean|0.29||0.2771||95.0|-0.25|0.88||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint|
1757590|NCT00227903|3228405|Superiority or Other (legacy)||Odds Ratio (OR)|1.23||||0.91|2-Sided|95.0|0.21|7.12|||Regression, Logistic||||
1757591|NCT00227903|3228406|Superiority or Other (legacy)||Odds Ratio (OR)|0.85||||0.91|2-Sided|95.0|0.14|5.23|||Regression, Logistic||||
1757441|NCT00232141|3228200|Superiority or Other||Mean Difference (Final Values)|0.29|Standard Error of the Mean|0.31||0.3553||95.0|-0.33|0.9||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14|
1757442|NCT00232141|3228200|Superiority or Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.28||0.5993||95.0|-0.7|0.41||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10|
1757443|NCT00232141|3228200|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.27||0.9964||95.0|-0.54|0.54||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6|
1757444|NCT00232141|3228200|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.26||0.8865||95.0|-0.55|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2|
1757445|NCT00232141|3228200|Superiority or Other||Mean Difference (Final Values)|-0.55|Standard Error of the Mean|0.23||0.0202||95.0|-1.01|-0.09||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1|
1757446|NCT00232141|3228201|Superiority or Other||Mean Difference (Final Values)|0.23|Standard Error of the Mean|0.27||0.4075||95.0|-0.31|0.77||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint|
1757447|NCT00232141|3228201|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.3||0.6596||95.0|-0.46|0.73||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14|
1757448|NCT00232141|3228201|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.27||0.3493||95.0|-0.79|0.28||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10|
1757449|NCT00232141|3228201|Superiority or Other||Mean Difference (Final Values)|-0.09|Standard Error of the Mean|0.27||0.7386||95.0|-0.63|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6|
1757450|NCT00232141|3228201|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.24||0.9444||95.0|-0.49|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2|
1757451|NCT00232141|3228201|Superiority or Other||Mean Difference (Final Values)|-0.26|Standard Error of the Mean|0.22||0.239||95.0|-0.69|0.17||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1|
1757452|NCT00232141|3228202|Superiority or Other||Mean Difference (Final Values)|0.13|Standard Error of the Mean|0.26||0.6158||95.0|-0.38|0.64||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint|
1757453|NCT00232141|3228202|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.27||0.6017||95.0|-0.4|0.68||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14|
1757454|NCT00232141|3228202|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.27||0.4753||95.0|-0.73|0.34||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10|
1757455|NCT00232141|3228202|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.26||0.2227||95.0|-0.83|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6|
1757456|NCT00232141|3228202|Superiority or Other||Mean Difference (Final Values)|-0.06|Standard Error of the Mean|0.27||0.8348||95.0|-0.58|0.47||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2|
1757592|NCT00227903|3228407|Superiority or Other (legacy)||Odds Ratio (OR)|1.33||||0.91|2-Sided|95.0|0.35|5.07|||Regression, Logistic||||
1757593|NCT00227903|3228408|Superiority or Other (legacy)||Odds Ratio (OR)|1.15||||0.91|2-Sided|95.0|0.32|4.2|||Regression, Logistic||||
1757457|NCT00232141|3228202|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.24||0.8605||95.0|-0.52|0.44||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1|
1757458|NCT00232141|3228203|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.3||0.8298||95.0|-0.53|0.66||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint|
1757459|NCT00232141|3228203|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.33||0.9045||95.0|-0.61|0.69||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14|
1757460|NCT00232141|3228203|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.29||0.9731||95.0|-0.57|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10|
1757461|NCT00232141|3228203|Superiority or Other||Mean Difference (Final Values)|-0.13|Standard Error of the Mean|0.29||0.6672||95.0|-0.71|0.45||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6|
1757462|NCT00232141|3228203|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.28||0.928||95.0|-0.52|0.57||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2|
1757463|NCT00232141|3228203|Superiority or Other||Mean Difference (Final Values)|-0.43|Standard Error of the Mean|0.23||0.0685||95.0|-0.89|0.03||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1|
1757464|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.34||0.0711||95.0|-1.3|0.05||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14|
1757465|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.67|Standard Error of the Mean|0.32||0.0359||95.0|-1.3|-0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 13|
1757466|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.55|Standard Error of the Mean|0.32||0.0866||95.0|-1.17|0.08||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 12|
1757467|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|0.3||0.144||95.0|-1.03|0.15||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 11|
1757468|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.29||0.1053||95.0|-1.04|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10|
1757469|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.29||0.1043||95.0|-1.06|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 9|
1757470|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.29||0.0184||95.0|-1.26|-0.12||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 8|
1757471|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.29||0.0359||95.0|-1.18|-0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 7|
1757472|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.55|Standard Error of the Mean|0.27||0.0452||95.0|-1.09|-0.01||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6|
1757594|NCT00227903|3228409|Superiority or Other (legacy)||Odds Ratio (OR)|0.62||||0.07|2-Sided|95.0|0.1|3.9|||Regression, Logistic||||
1757595|NCT00227903|3228410|Superiority or Other (legacy)||Odds Ratio (OR)|0.28||||0.07|2-Sided|95.0|0.08|1.02|||Regression, Logistic||||
1757473|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.26||0.1849||95.0|-0.87|0.17||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 5|
1757474|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.34|Standard Error of the Mean|0.27||0.2088||95.0|-0.86|0.19||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 4|
1757475|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.58|Standard Error of the Mean|0.27||0.031||95.0|-1.1|-0.05||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 3|
1757476|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.63|Standard Error of the Mean|0.23||0.0067||95.0|-1.08|-0.18||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2|
1757477|NCT00232141|3228205|Superiority or Other||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|0.18||0.0469||95.0|-0.71|0.0||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1|
1757478|NCT00232141|3228206|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.25||0.1277||95.0|-0.86|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA||||
1757479|NCT00232141|3228207|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.38||0.7689||95.0|-0.64|0.86||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Cold hyperalgesia testing area|
1757480|NCT00232141|3228207|Superiority or Other||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.33||0.3767||95.0|-0.93|0.35||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Cold allodynia testing area|
1757481|NCT00232141|3228207|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.33||0.6088||95.0|-0.82|0.48||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Temporal summation to tactile stimuli|
1757482|NCT00232141|3228207|Superiority or Other||Mean Difference (Final Values)|-0.1|Standard Error of the Mean|0.35||0.7704||95.0|-0.79|0.59||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Punctate hyperalgesia testing area|
1757483|NCT00232141|3228207|Superiority or Other||Mean Difference (Final Values)|-0.22|Standard Error of the Mean|0.25||0.3787||95.0|-0.71|0.27||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Dynamic mechanical allodynia|
1757484|NCT00232141|3228207|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.29||0.6865||95.0|-0.45|0.68||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Static mechanical allodynia|
1757485|NCT00232141|3228208|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.0||0.5898||95.0|0.0|0.0||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Total Score|
1757486|NCT00232141|3228208|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.03||0.1849||95.0|-0.02|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Paresthesia/dysesthesia|
1757487|NCT00232141|3228208|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.03||0.6479||95.0|-0.07|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Evoked|
1757488|NCT00232141|3228208|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.03||0.6838||95.0|-0.05|0.07||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Paroxysmal|
1757596|NCT00227903|3228411|Superiority or Other (legacy)||Odds Ratio (OR)|1.46||||0.07|2-Sided|95.0|0.47|4.52|||Regression, Logistic||||
1757489|NCT00232141|3228208|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.03||0.6147||95.0|-0.07|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pressing|
1757490|NCT00232141|3228208|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.03||0.3097||95.0|-0.03|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Burning|
1757491|NCT00232141|3228209|Superiority or Other|||||||0.3852||||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel||||
1757492|NCT00232141|3228210|Superiority or Other|||||||0.0077||||||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel||||
1757493|NCT00232141|3228211|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.27||0.4776||95.0|-0.73|0.34||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA||||
1757494|NCT00232141|3228212|Superiority or Other||Mean Difference (Final Values)|0.07|Standard Error of the Mean|0.25||0.7783||95.0|-0.43|0.57||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pain Interference Index|
1757495|NCT00232141|3228212|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.27||0.5834||95.0|-0.38|0.67||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Pain Severity Index|
1757496|NCT00232141|3228213|Superiority or Other||Mean Difference (Final Values)|0.42|Standard Error of the Mean|0.37||0.2513||95.0|-0.3|1.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Depression|
1757497|NCT00232141|3228213|Superiority or Other||Mean Difference (Final Values)|0.26|Standard Error of the Mean|0.39||0.5105||95.0|-0.51|1.03||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Anxiety|
1757498|NCT00232141|3228214|Superiority or Other||Mean Difference (Final Values)|1.42|Standard Error of the Mean|1.89||0.4516||95.0|-2.3|5.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Sleep Problems Index II|
1757499|NCT00232141|3228214|Superiority or Other||Mean Difference (Final Values)|1.07|Standard Error of the Mean|1.98||0.5882||95.0|-2.83|4.97||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Sleep Problems Index I|
1757500|NCT00232141|3228214|Superiority or Other||Mean Difference (Final Values)|9.34|Standard Error of the Mean|3.21||0.004||95.0|3.02|15.66||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Snoring|
1757501|NCT00232141|3228214|Superiority or Other||Mean Difference (Final Values)|1.4|Standard Error of the Mean|2.5||0.5775||95.0|-3.54|6.33||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Somnolence|
1757502|NCT00232141|3228214|Superiority or Other||Mean Difference (Final Values)|1.41|Standard Error of the Mean|2.51||0.5742||95.0|-3.53|6.35||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Awaken Short of Breath or with Headache|
1757503|NCT00232141|3228214|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|2.92||0.9886||95.0|-5.81|5.72||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Adequacy|
1757504|NCT00232141|3228214|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.25||0.3184||95.0|-0.75|0.25||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Quantity|
1757505|NCT00232141|3228214|Superiority or Other||Mean Difference (Final Values)|1.54|Standard Error of the Mean|2.53||0.5425||95.0|-3.44|6.52||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Disturbance.|
1757506|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|0.86||||0.5437||95.0|0.534|1.39||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Endpoint-BOCF|
1757507|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|1.37||||0.2796||95.0|0.768|2.432||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 14|
1757508|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|1.17||||0.5819||95.0|0.663|2.079||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 13|
1757509|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|1.48||||0.1602||95.0|0.856|2.575||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 12|
1757510|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|1.21||||0.49||95.0|0.699|2.104||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 11|
1757511|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|0.85||||0.5635||95.0|0.486|1.482||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 10|
1757512|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|1.12||||0.6815||95.0|0.66|1.89||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 9|
1757513|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|1.48||||0.1602||95.0|0.864|2.527||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 8|
1757514|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|1.05||||0.845||95.0|0.627|1.769||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 7|
1757515|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|0.8||||0.3842||95.0|0.481|1.33||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 6|
1757516|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|0.92||||0.7479||95.0|0.556|1.527||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 5|
1757517|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|1.23||||0.4216||95.0|0.7444|2.025||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 4|
1757518|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|1.44||||0.1546||95.0|0.877|2.375||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 3|
1757519|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|1.2||||0.4687||95.0|0.731|1.978||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 2|
1757520|NCT00232141|3228215|Superiority or Other||Odds Ratio (OR)|1.62||||0.1132||95.0|0.882|2.969||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 1|
1757521|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|0.79||||0.3482||95.0|0.486|1.283||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Endpoint-BOCF|
1757522|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|1.02||||0.9586||95.0|0.574|1.796||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 14|
1757597|NCT00227903|3228412|Superiority or Other (legacy)||Odds Ratio (OR)|1.18||||0.07|2-Sided|95.0|0.44|3.14|||Regression, Logistic||||
1757598|NCT00227903|3228413|Superiority or Other (legacy)||Odds Ratio (OR)|0.76||||0.5|2-Sided|95.0|0.27|2.11|||Regression, Logistic||||
1757523|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|1.09||||0.7712||95.0|0.612|1.946||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 13|
1757524|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|1.04||||0.8853||95.0|0.597|1.818||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 12|
1757525|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|0.92||||0.7737||95.0|0.522|1.619||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 11|
1757526|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|0.89||||0.6845||95.0|0.513|1.546||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 10|
1757527|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|1.19||||0.527||95.0|0.697|2.046||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 9|
1757528|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|1.41||||0.2107||95.0|0.829|2.401||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 8|
1757529|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|1.57||||0.1055||95.0|0.913|2.701||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 7|
1757530|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|1.09||||0.7399||95.0|0.654|1.817||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 6|
1757531|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|1.07||||0.7852||95.0|0.644|1.794||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 5|
1757532|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|1.25||||0.414||95.0|0.735|2.116||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 4|
1757533|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|1.13||||0.6859||95.0|0.638|1.985||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 3|
1757534|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|1.24||||0.5041||95.0|0.666|2.301||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 2|
1757535|NCT00232141|3228216|Superiority or Other||Odds Ratio (OR)|2.18||||0.1191||95.0|0.802|5.935||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|Cochran-Mantel-Haenszel|||Table above shows results of statistical analysis for Week 1|
1757536|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.08|Standard Error of the Mean|0.3||0.7925||95.0|-0.66|0.5||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Endpoint|
1757537|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.37||0.1856||95.0|-1.21|0.24||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 14|
1757538|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.63|Standard Error of the Mean|0.34||0.0662||95.0|-1.3|0.04||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 13|
1757539|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.56|Standard Error of the Mean|0.34||0.1025||95.0|-1.22|0.11||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 12|
1757599|NCT00227903|3228414|Superiority or Other (legacy)|||||||0.1|||||||Mixed Models Analysis||||
1757600|NCT00227903|3228415|Superiority or Other (legacy)|||||||0.1|||||||Mixed Models Analysis||||
1757540|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.43|Standard Error of the Mean|0.33||0.1874||95.0|-1.08|0.21||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 11|
1757541|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.32|Standard Error of the Mean|0.31||0.306||95.0|-0.93|0.29||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 10|
1757542|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.32||0.0981||95.0|-1.15|0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 9|
1757543|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.75|Standard Error of the Mean|0.31||0.0156||95.0|-1.36|-0.14||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 8|
1757544|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.69|Standard Error of the Mean|0.32||0.0307||95.0|-1.32|-0.07||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 7|
1757545|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.31||0.0879||95.0|-1.13|0.08||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 6|
1757546|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.3||0.3345||95.0|-0.89|0.3||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 5|
1757547|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.29||0.1513||95.0|-0.99|0.15||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 4|
1757548|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.54|Standard Error of the Mean|0.28||0.0554||95.0|-1.08|0.01||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 3|
1757549|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.49|Standard Error of the Mean|0.24||0.0393||95.0|-0.96|-0.02||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 2|
1757550|NCT00232141|3228217|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.18||0.0131||95.0|-0.81|-0.1||All statistical tests of hypotheses were two-sided and at the 5% level of significance. All p-values for secondary or supportive analyses will be considered descriptive. No multiplicity adjustment was made for this two-group study.|ANCOVA|||Table above shows results of statistical analysis for Week 1|
1757551|NCT00232141|3228218|Superiority or Other||Mean Difference (Final Values)|-0.25|Standard Error of the Mean|0.29||0.3914||95.0|-0.83|0.32||The analysis procedures planned will control the Type I error for the primary analysis. No multiplicity adjustment is needed for this two-group study.|ANCOVA|||Primary hypotheses : null (H0): µA=µP vs alternative (HA): µA≠µP (µA and µP represent true means for primary endpoint in active treatment & placebo groups respectively). Assumptions in power calculation: 2-sided test with type I error at α =0.05, type II error at β =0.10, & a common s.d of 2.2 for primary endpoint (based on previous clinical trial data). With n=150 subjects/ group (300 subjects overall) at least 90% power to detect a treatment difference of at least 1.1 in primary endpoint|
1757552|NCT00231283|3228268|Superiority or Other||Percentage of participants|10.4||||||95.0|5.1|18.3|||||||
1757553|NCT00231283|3228269|Superiority or Other||Percentage of participants|3.0||||||95.0|0.6|8.5|||||||
1757554|NCT00231283|3228270|Superiority or Other||Percentage of participants|3.0||||||95.0|0.6|8.6|||||||
1757555|NCT00231283|3228271|Superiority or Other||Percentage of participants|97.0|Standard Error of the Mean|1.71||||95.0|91.5|99.4|||||||
1757556|NCT00231179|3228272|Non-Inferiority or Equivalence|See previous.|Hazard Ratio (HR)|3.0|Standard Error of the Mean|3.0||0.64|2-Sided|95.0|||||Chi-squared||||
1757557|NCT00231179|3228273|Non-Inferiority or Equivalence|See previous.|Hazard Ratio (HR)|3.0|Standard Error of the Mean|3.0|<|0.05|2-Sided|95.0|||||Chi-squared||||
1757558|NCT00231179|3228274|Non-Inferiority or Equivalence|See previous.|Hazard Ratio (HR)|10.0|Standard Error of the Mean|5.0|<|0.01|2-Sided|95.0|||||Chi-squared||||
1757559|NCT00231179|3228275|Non-Inferiority or Equivalence|Please see earlier power calculation.|Hazard Ratio (HR)|10.0|Standard Error of the Mean|5.0||0.72|2-Sided|95.0|||||Chi-squared||||
1757560|NCT00231179|3228276|Non-Inferiority or Equivalence|Sample sizes were established when the trial was first developed. For all power calculations, we set alpha = .05 and beta = .20 and specified 2-tailed tests.|Mean Difference (Final Values)|0.81|Standard Deviation|15.0||0.59|2-Sided|95.0|0.31|2.13||Bonferroni corrections were made for multiple comparisons.|t-test, 2 sided|||We compared scores for verbal, performance, and full scale Intelligence Quotient (IQ).|
1757563|NCT00231153|3228279|Superiority or Other||Net percentage difference|2.25||||0.082||95.0|-0.3|4.81||The primary null hypothesis was tested using the CMH chi-square test stratified region: North America or Europe. Alpha for this test will be 0.05, tow-tailed. No adjustment for multiplicity was performed.|Cochran-Mantel-Haenszel|||Adequate power was provided to test the null hypothesis that there would be no difference between treatment groups for LCSI. Overall LCSI rate was assumed to be approx. 7.5%, with reduction of LCSI by 40% with omiganan. LCSI rates in placebo and omiganan groups would be 9.375% and 5.625%. Sample size of 1548 in MITT set would provide 80% power to detect this difference between treatments. Sample size was also increased by 19% to account for deaths, for total of 1850 planned patients.|
1757564|NCT00230971|3228298|Superiority or Other|||||||0.717|||||||ANOVA|Treatment as a factor||Inpatient hospitalization, non-ICU|
1757565|NCT00230971|3228298|Superiority or Other|||||||0.191|||||||ANOVA|Treatment as a factor||ICU treatment|
1757566|NCT00230971|3228298|Superiority or Other|||||||0.655|||||||ANOVA|Treatment as a factor||Primary inpatient hospitalization|
1757567|NCT00230971|3228298|Superiority or Other|||||||0.75|||||||ANOVA|Treatment as a factor||Overall inpatient hospitalization|
1757568|NCT00230971|3228299|Non-Inferiority or Equivalence|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|2.7||||||95.0|-7.9|13.3|||||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.|Group comparison of eradication + presumed eradication|
1757569|NCT00230971|3228300|Non-Inferiority or Equivalence|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|1.8||||0.001||95.0|-8.8|12.5|||t-test, 1 sided||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.||
1757570|NCT00230971|3228301|Non-Inferiority or Equivalence|A 2-sided 95% CI (corrected for continuity) was calculated for the true difference between the cure rates. Non-inferiority will be concluded if the lower limit of the 2-sided CI is greater than -15%.|Risk Difference (RD)|1.6||||||95.0|-6.4|9.6|||||Estimates of the difference, CI and hypothesis tests are weighted by using minimum risk weights.||
1757571|NCT00230737|3228305|Superiority or Other||Mean Difference (Final Values)|3594.0|||<|0.001|2-Sided||||||t-test, 2 sided||||
1757572|NCT00230178|3228309|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1757573|NCT00230178|3228309|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1757574|NCT00230178|3228310|Superiority or Other||Difference in response rate %|12.3||||0.0632||95.0|-0.9|25.0|||Wilson's method||||
1757575|NCT00230178|3228310|Superiority or Other||Difference in response rate %|21.0||||0.0009||95.0|8.6|32.7|||Wilson's method||||
1757576|NCT00230100|3228317|Superiority or Other||||||<|0.009|||||||Mixed Models Analysis||||
1757577|NCT00230100|3228318|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||It was hypothesized that the single-gender group composition and women-focused group content (WRG) would result in better substance abuse treatment outcomes (lower ASI alcohol composite scores) than standard mixed-gender group treatment (GDC).|
1757578|NCT00230100|3228319|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a “mixed” model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis).|
1757579|NCT00230100|3228320|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a “mixed” model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis).|
1757580|NCT00230100|3228321|Superiority or Other||||||<|0.05|||||||Mixed Models Analysis|||Implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. The MMANOVA approach estimates a separate mean for each phase of treatment per group. The MMANOVA is called a “mixed” model because it includes both fixed (e.g., treatment, gender) and random (subject-specific) terms. MMANOVA allows for randomly missing observations (not included in analysis).|
1757581|NCT00229970|3228330|Superiority or Other||Mean Difference (Final Values)|0.17|||<|0.001||95.0|0.09|0.24|||ANCOVA|The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.|||
1757582|NCT00229970|3228330|Superiority or Other||Mean Difference (Final Values)|0.09|||<|0.022||95.0|0.01|0.16|||ANCOVA|The model included a factor for treatment and using the baseline Forced Expiratory Volume in One Second (FEV1) as a covariate.|||
1757583|NCT00228566|3228378|Superiority or Other||% Responders = 201/241|83.4||||||95.0|78.7|88.1|||||The Overall Endpoint includes the last postbaseline value for each patient in the full analysis set, regardless of evaluation period. The Number of Responders (at least minimal improvement) at this Overall Endpoint equaled a total of 201 patients.|This was an open label study, with all patients receiving treatment with armodafinil|
1757584|NCT00227903|3228399|Superiority or Other (legacy)||||||>|0.05|||||||Chi-squared||||
1757585|NCT00227903|3228400|Superiority or Other (legacy)|||||||0.01|||||||Cochran-Mantel-Haenszel||||
1757586|NCT00227903|3228401|Superiority or Other (legacy)||Odds Ratio (OR)|0.4||||0.04|2-Sided|95.0|0.04|3.74|||Regression, Logistic||||
1757587|NCT00227903|3228402|Superiority or Other (legacy)||Odds Ratio (OR)|0.25||||0.04|2-Sided|95.0|0.04|1.63|||Regression, Logistic||||
1757588|NCT00227903|3228403|Superiority or Other (legacy)||Odds Ratio (OR)|1.21||||0.04|2-Sided|95.0|0.35|4.17|||Regression, Logistic||||
1757589|NCT00227903|3228404|Superiority or Other (legacy)||Odds Ratio (OR)|1.28||||0.04|2-Sided|95.0|0.46|3.55|||Regression, Logistic||||
1757606|NCT00227903|3228421|Superiority or Other (legacy)||Odds Ratio (OR)|1.05||||0.79|2-Sided|95.0|0.42|2.62|||Regression, Logistic||||
1757607|NCT00227903|3228422|Superiority or Other (legacy)||Odds Ratio (OR)|0.77||||0.79|2-Sided|95.0|0.36|1.67|||Regression, Logistic||||
1757608|NCT00227903|3228423|Superiority or Other (legacy)|||||||0.41|||||||Fisher Exact||||
1757609|NCT00227903|3228424|Superiority or Other (legacy)|||||||0.88||||||Not corrected for multiple comparison.|Mixed Models Analysis|2 degrees of freedom||We estimated that 110 people with 10% attrition would provide 80% power.|
1757610|NCT00227903|3228425|Superiority or Other (legacy)|||||||0.08|||||||Fisher Exact||||
1757611|NCT00227903|3228426|Superiority or Other (legacy)|||||||0.88||||||Not corrected for multiple comparison|Mixed Models Analysis|2 degrees of freedom||We estimated that 110 people with 10% attrition would provide 80% power|
1757612|NCT00227877|3228427|Superiority||Adjusted Relative Risk Ratio|0.73|Standard Error of the Mean|0.11|<|0.05|2-Sided|95.0|0.54|0.98|||Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.||
1757613|NCT00227877|3228428|Superiority||Adjusted Relative Risk Ratio|0.63|Standard Error of the Mean|0.1|<|0.01|2-Sided|95.0|0.46|0.87|||Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; connectedness to provider, and baseline DRWI risk.||
1757614|NCT00227877|3228429|Superiority||Adjusted Relative Risk Ratio|0.87|Standard Error of the Mean|0.13||0.35|2-Sided|95.0|0.64|1.17||Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Regression, Logistic||Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.||
1757615|NCT00227877|3228430|Superiority||Adjusted Relative Risk Ratio|0.66|Standard Error of the Mean|0.11||0.66|2-Sided|95.0|0.48|0.91|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention)/(Control) controlling for age; gender; parent education; number of parents in home; visit type; provider gender; connectedness to provider, and baseline DRWI risk.||
1757616|NCT00227877|3228431|Superiority||Adjusted Relative Risk Ratio|0.74|Standard Error of the Mean|0.15||0.13|2-Sided|95.0|0.51|1.09|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.||
1757617|NCT00227877|3228432|Superiority||Adjusted Relative Risk Ratio|0.85|Standard Error of the Mean|0.5||0.78|2-Sided|95.0|0.27|2.7|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.||
1757618|NCT00227877|3228433|Superiority||Adjusted Relative Risk Ratio|0.96|Standard Error of the Mean|0.41||0.93|2-Sided|95.0|0.42|2.21|||Regression, Logistic||Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age and gender.||
1757619|NCT00227877|3228434|Superiority||Adjusted Relative Risk Ratio|1.52|Standard Error of the Mean|0.34||0.07|2-Sided|95.0|0.97|2.36|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age and gender.||
1757620|NCT00227877|3228435|Superiority||Adjusted Relative Risk Ratio|0.79|Standard Error of the Mean|0.16||0.23|2-Sided|95.0|0.53|1.16|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.||
1757621|NCT00227877|3228436|Superiority||Adjusted Relative Risk Ratio|1.8|Standard Error of the Mean|0.55||0.05|2-Sided|95.0|0.99|3.27|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|||Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.
1757622|NCT00227877|3228437|Superiority||Adjusted Relative Risk Ratio|0.7|Standard Error of the Mean|0.25||0.32|2-Sided|95.0|0.34|1.42|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Initiation)/(Control Initiation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.||
1757623|NCT00227877|3228438|Superiority||Adjusted Relative Risk Ratio|1.39|Standard Error of the Mean|0.18|<|0.05|2-Sided|95.0|1.08|1.8|||Regression, Logistic|Group Conditional Risk Ratio adjusting for the multi-site sample design using GEE logistic regression (SUDAAN 10.0)|Risk Ratio: (Intervention Cessation)/(Control Cessation) controlling for age; gender; parent education; number of parents in home; visit type; perceived parent, sibling, and peer substance use; provider gender; and connectedness to provider.||
1757624|NCT00227266|3228484|Superiority or Other||Spearman's correlation|0.93|||<|0.001|||||||Spearman's correlation|||MHFMS-Extend was not normally distributed at p=0.048. Test-retest reliability of MHFMS-Extend measurements from the first (S1) to the second (S2) screening visit was analyzed using Spearman’s correlation.|
1757625|NCT00226811|3228504|Superiority or Other||OR rate (percentage)|2.6||||||95.0|0.3|9.0|||||Percentage of patients with confirmed complete response or confirmed partial response according to the Response Evaluation Criteria in Solid Tumors (RECIST), relative to the total number of treated patients.||
1757626|NCT00226811|3228509|Superiority or Other||CBR rate (percentage)|7.7||||||95.0|2.9|16.0|||||Clinical benefit response rate: percent of patients with confirmed complete response, confirmed partial response or stable disease for at least 24 wks according to Response Evaluation Criteria in Solid Tumors, relative to total treated patients||
1757627|NCT00226499|3228533|Other|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|68.932||||0.1265|2-Sided|95.0|61.893|74.671|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.|
1757628|NCT00226499|3228533|Other|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|94.816|||<|0.0001|2-Sided|95.0|92.838|96.248|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.|
1757629|NCT00226499|3228534|Other|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|89.532||||0.1265|2-Sided|95.0|86.126|92.102|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.|
1757630|NCT00226499|3228534|Other|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|99.072|||<|0.0001|2-Sided|95.0|97.907|99.589|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.|
1757631|NCT00226499|3228535|Other|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|69.812||||0.1265|2-Sided|95.0|62.848|75.47|||Regression, Cox|||VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.|
1757632|NCT00226499|3228535|Other|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|95.855|||<|0.0001|2-Sided|95.0|94.075|97.101|||Regression, Cox|||VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.|
1757633|NCT00226499|3228555|Other|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|64.585||||0.1265|2-Sided|95.0|57.503|70.486|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.|
1757634|NCT00226499|3228555|Other|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|92.487|||<|0.0001|2-Sided|95.0|89.927|94.396|||Regression, Cox|||VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.|
1757635|NCT00226499|3228556|Other|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|90.741||||0.1265|2-Sided|95.0|85.866|93.934|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.|
1757636|NCT00226499|3228556|Other|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|99.498||||0.0001|2-Sided|95.0|97.522|99.898|||Regression, Cox|||VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.|
1757637|NCT00226499|3228557|Other|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Varilrix as compared to Priorix).|Vaccine Efficacy|65.428||||0.1265|2-Sided|97.5|57.182|72.086|||Regression, Cox|||Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.|
1757638|NCT00226499|3228557|Other|To demonstrate at least 60% VE, with respect to confirmed varicella disease over at least a two-year period of follow-up (beginning 42 days post dose 2) of Priorix-Tetra as compared to Priorix).|Vaccine Efficacy|94.943|||<|0.0001|2-Sided|97.5|92.446|96.615|||Regression, Cox|||Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.|
1757639|NCT00225277|3228582|Superiority or Other|||||||0.663||||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank||||
1757640|NCT00225277|3228583|Superiority or Other|||||||0.883||||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank||||
1757641|NCT00225277|3228584|Superiority or Other|||||||0.744||||||Kaplan-Meier methodology was used to estimate the time to event for each composite endpoint. The p-value was based on a log-rank test.|Log Rank||||
1757642|NCT00225277|3228585|Superiority or Other||Mean Difference (Final Values)|-4.048||||0.064||95.0|-8.3336|0.2374|||ANCOVA||Mean Difference = Pioglitazone - Glimepiride|2 Way ANCOVA, treatment and center effects with baseline value as covariate. LS mean of the treatment difference reported.|
1757643|NCT00225277|3228586|Superiority or Other||Mean Difference (Final Values)|-0.886||||0.002||95.0|-1.448|-0.325|||ANCOVA||Mean Difference = Pioglitazone - Glimepiride|2 Way analysis of covariance (ANCOVA), treatment and center effects with baseline value as covariate. Least Squares (LS) mean change and LS mean of the treatment difference reported.|
1757644|NCT00225251|3228591|Superiority or Other||Mean Difference (Net)|3.0|||<|0.05|||||||t-test, 2 sided||||
1757645|NCT00225147|3228594|Superiority or Other||||||<|0.001|||||||Log Rank||||
1757646|NCT00225147|3228594|Superiority or Other||||||<|0.04|||||||Log Rank||||
1757647|NCT00225147|3228595|Superiority or Other||||||<|0.001|||||||Log Rank||||
1757648|NCT00225147|3228595|Superiority or Other||||||<|0.001|||||||Log Rank||||
1757649|NCT00225017|3228596|Superiority or Other|||||||0.141|||||||Wilcoxon (Mann-Whitney)||||
1757651|NCT00225017|3228598|Non-Inferiority or Equivalence|25 subjects per arm will have 80% power to detect a difference between groups in mean FMD change of 2.9%, and 90% power to detect a mean FMD change of 3.4%|Mean Difference (Net)|-0.384|Standard Deviation|1.0||0.601|2-Sided|95.0|-2.08|1.312|||Wilcoxon (Mann-Whitney)||||
1757652|NCT00224952|3228599|Other|||||||0.469|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery Total NAC conjugates) as a function of age|
1757653|NCT00224952|3228599|Other|||||||0.925|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery NAC-2-ene VPA) ) as a function of age|
1757654|NCT00224952|3228599|Other|||||||0.522|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery NAC-3-ene VPA isomers)) as a function of age|
1757655|NCT00224952|3228599|Other||||||<|0.0001|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Total N-acetylcysteine conjugates) as a function of age|
1757656|NCT00224952|3228599|Other||||||<|0.0003|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (5-N-acetylcysteine-2-ene VPA) ) as a function of age|
1757657|NCT00224952|3228599|Other||||||<|0.0004|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (5-N-acetylcysteine-3-ene VPA isomers)) as a function of age|
1757658|NCT00224952|3228599|Other||||||<|0.033|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (Fractional Recovery MTHIS)) as a function of age|
1757659|NCT00224952|3228599|Other||||||<|0.018|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Fractional Recovery (MTHIS)) as a function of age|
1757660|NCT00224952|3228599|Other||||||<|0.032|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (Log (4-Methylthio-2-hydroxyiminostilbene) as a function of age|
1757661|NCT00224952|3228599|Other||||||<|0.004|||||||Regression, Linear|||Least squares linear regression evaluating fractional analyte recovery (4-Methylthio-2-hydroxyiminostilbene) as a function of age|
1757662|NCT00224770|3228610|Superiority or Other||Risk Difference (RD)|19.2|Standard Error of the Mean|14.9||0.156|1-Sided|95.0||43.7|||Fisher Exact|One-sided test|ICES rate=42.9, 95% upper limit=67.5; medical rate=23.7, 95% upper limit=37.7; comparison considers ICES rate minus medical rate.|Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher proportion than the medical arm.|
1757663|NCT00224770|3228610|Superiority or Other||Risk Difference (RD)|10.9|Standard Error of the Mean|9.5||0.189|1-Sided|95.0||26.6|||Fisher Exact|One-sided test|MISTIE rate=34.6, 95% upper limit=46.9; medical rate=23.7, 95% upper limit=37.7; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher proportion than the medical arm.|
1757664|NCT00224770|3228611|Superiority or Other|||||||0.791|||||||Sign test|Two-sided||Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.|
1757665|NCT00224770|3228611|Superiority or Other||||||<|0.0001|||||||Sign test|Two-sided test||Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.|
1757666|NCT00224770|3228612|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.|
1757667|NCT00224770|3228612|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.|
1757668|NCT00224770|3228613|Superiority or Other|||||||0.175|||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.|
1757669|NCT00224770|3228613|Superiority or Other|||||||0.395|||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.|
1757670|NCT00224770|3228614|Superiority or Other|||||||0.294|||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.|
1757671|NCT00224770|3228614|Superiority or Other|||||||0.468|||||||Wilcoxon (Mann-Whitney)|Two-sided test||Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.|
1757672|NCT00224770|3228615|Superiority or Other||Risk Difference (RD)|-2.4|Standard Error of the Mean|2.4||0.75|1-Sided|95.0||2.2|||Fisher Exact|One-sided test|ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate|Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of symptomatic rebleeding than the medical arm.|
1757673|NCT00224770|3228615|Superiority or Other||Risk Difference (RD)|3.2|Standard Error of the Mean|3.9||0.409|1-Sided|95.0||9.6|||Fisher Exact|One-sided test|MISTIE rate=5.6, 95% upper limit=13.7; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate|Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of symptomatic rebleeding than the medical arm.|
1757674|NCT00224770|3228616|Superiority or Other||Risk Difference (RD)|-2.4|Standard Error of the Mean|2.4||0.75|1-Sided|95.0||1.5|||Fisher Exact|One-sided test|ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate.|Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of these infections than medical.|
1757675|NCT00224770|3228616|Superiority or Other||Risk Difference (RD)|-2.4|Standard Error of the Mean|2.4||0.437|1-Sided|95.0||1.5|||Fisher Exact|One-sided test|MISTIE rate=0.0, 95% upper limit=5.4; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of these infections than medical.|
1757676|NCT00224770|3228617|Superiority or Other||Risk Difference (RD)|5.6|Standard Error of the Mean|3.1||0.174|1-Sided|95.0||11.7|||Fisher Exact|One-sided test|MISTIE rate=5.6, 95% upper limit=13.7; medical rate=0.0, 95% upper limit=6.9; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of procedure-related mortality within 7 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of procedure-related mortality than the medical arm.|
1757677|NCT00224770|3228618|Superiority or Other||Risk Difference (RD)|-2.4|Standard Error of the Mean|8.2||0.633|1-Sided|95.0||11.2|||Fisher Exact|One-sided test|ICES rate=7.1, 95% upper limit=29.7; medical rate=9.5, 95% upper limit=20.5; comparison considers ICES rate minus medical rate.|Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of mortality than the medical arm.|
1757678|NCT00224770|3228618|Superiority or Other||Risk Difference (RD)|5.3|Standard Error of the Mean|6.6||0.324|1-Sided|95.0||16.2|||Fisher Exact|One-sided test|MISTIE rate=14.8, 95% upper limit=25.1; medical rate=9.5, 95% upper limit=20.5; comparison considers MISTIE rate minus medical rate.|Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of mortality than the medical arm.|
1757679|NCT00223821|3228676|Superiority or Other||Mean Difference (Final Values)|6.8|Standard Error of the Mean|8.71||0.37|2-Sided|95.0|-10.73|24.33|||ANCOVA|ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.|||
1757680|NCT00223821|3228677|Superiority or Other||Mean Difference (Final Values)|10.2|Standard Error of the Mean|7.65||0.16|2-Sided|95.0|-5.13|25.54|||ANCOVA|ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.||The effectiveness of each intervention was calculated by comparing the weekly frequency of incontinent episodes (derived from seven-day bladder diaries) during baseline to that in the immediate post-intervention period (week 8). The primary analysis was based on intent-to-treat, in which post-treatment frequency of incontinence for non-completers was derived from the most recent week of diaries.|
1757681|NCT00223704|3228683|Superiority or Other||||||<|0.001||||||The P-value reflects the difference in D-dimer concentrations among the 3 treatment groups over the course of the study (baseline, 30min, 60min, post-bypass, and postoperative day 1)|Mixed Models Analysis|||The time course for D-dimer concentrations were analyzed using mixed-effects models with fixed effects of drug treatment (placebo, aminocaproic acid, HOE 140) and time since randomization. We included a random subject effect and a first-order autoregressive process to account for the correlation in the response variable in the mixed-effects model|
1757682|NCT00223704|3228684|Superiority or Other|||||||0.92||||||The P-value reflects the difference in Interleukin-6 concentrations among the 3 treatment groups over the course of the study (baseline, post-bypass, postoperative day 1 and 2)|Mixed Models Analysis|||The time course for Interleukin-6 concentrations were analyzed using mixed-effects models with fixed effects of drug treatment (placebo, aminocaproic acid, HOE 140) and time since randomization. We included a random subject effect and a first-order autoregressive process to account for the correlation in the response variable in the mixed-effects model|
1757683|NCT00223704|3228685|Superiority or Other|||||||0.43|||||||Kruskal-Wallis||||
1757684|NCT00223704|3228686|Superiority or Other|||||||0.88|||||||Kruskal-Wallis||||
1757685|NCT00223704|3228687|Superiority or Other|||||||0.72||||||This P-value is for the main comparison of receiving any transfusion.|Chi-squared||||
1757686|NCT00223678|3228688|Superiority or Other|||||||0.849|||||||Log Rank||||
1757687|NCT00223652|3228704|Superiority or Other||||||>|0.37|||||||Generalized estimating equations models||||
1757688|NCT00223652|3228705|Superiority or Other||||||>|0.37|||||||Mixed Models Analysis||||
1757689|NCT00223652|3228706|Superiority or Other|||||||0.86|||||||Generalized estimating equations models||||
1757690|NCT00223652|3228706|Superiority or Other|||||||0.12|||||||Generalized estimating equations models||||
1757691|NCT00223652|3228706|Superiority or Other||||||<|0.0001|||||||Generalized estimating equations models||||
1757692|NCT00223652|3228707|Superiority or Other|||||||0.2|||||||Mixed Models Analysis||||
1757693|NCT00223652|3228707|Superiority or Other|||||||0.61|||||||Mixed Models Analysis||||
1757694|NCT00223652|3228707|Superiority or Other||||||<|0.0001|||||||Mixed Models Analysis||||
1757695|NCT00223652|3228708|Superiority or Other||||||>|0.37|||||||Mixed Models Analysis||||
1757696|NCT00223652|3228709|Superiority or Other|||||||0.95|||||||Mixed Models Analysis||||
1757697|NCT00223652|3228709|Superiority or Other|||||||0.07|||||||Mixed Models Analysis||||
1757698|NCT00223652|3228709|Superiority or Other||||||=|0|||||||Mixed Models Analysis||||
1757699|NCT00223236|3228715|Superiority or Other|||||||0.4637|||||||Chi-squared|df=1 n=34||Null hypothsis is no group association in cocaine use.|
1757700|NCT00221195|3228732|Superiority or Other (legacy)||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||The Wilcoxin signed-rank test was used to compare the frequency of bleeds between the prophylaxis and on-demand periods.|
1757701|NCT00221117|3228734|Superiority or Other|||||||0.05|||||||Regression, Linear|||The subject’s impairment and demographic characteristics were analyzed using descriptive statistics for parametric and nonparametric data. The baseline outcome data of the intervention and control groups were compared using Fisher exact test (for categorical variables) and Mann–Whitney U test (for continuous variables). Comparisons between the intervention and control groups were carried out using linear regression analysis adjusted for the baseline degree of disability (baseline AIS).|
1757702|NCT00221117|3228735|Other|||||||0.015|||||||Wilcoxon (Mann-Whitney)||||
1757725|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-733.59|733.59||||||For change in indigestion at EoS, mean change difference was used to compare the two treatment groups.|
1757703|NCT00221104|3228736|Superiority or Other||Hazard Ratio (HR)|1.0||||0.9953|2-Sided|95.0|0.45|2.22|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)|
1757704|NCT00221104|3228737|Superiority or Other||Hazard Ratio (HR)|2.36||||0.1986|2-Sided|95.0|0.61|9.14|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)|
1757705|NCT00221104|3228738|Superiority or Other||Hazard Ratio (HR)|1.25||||0.3075|2-Sided|95.0|0.81|1.91|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)|
1757706|NCT00221104|3228739|Superiority or Other||Hazard Ratio (HR)|0.33||||0.0047|2-Sided|95.0|0.15|0.74|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)|
1757707|NCT00221104|3228740|Superiority or Other||Hazard Ratio (HR)|0.97||||0.8234|2-Sided|95.0|0.73|1.29|||Stratified log-rank test|log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus|the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)|
1757708|NCT00220805|3228747|Superiority or Other|||||||0.74|||||||Cochran-Mantel-Haenszel|Adjusted to centers|||
1757709|NCT00220805|3228749|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.9|2-Sided|95.0|-0.21|0.19|||ANOVA||||
1757710|NCT00220805|3228750|Superiority or Other|||||||0.13|||||||Cochran-Mantel-Haenszel|Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers)|||
1757711|NCT00220805|3228751|Superiority or Other|||||||0.76||||||Adjusted for centers (including a Breslow-Day test for homogeneity of odd ratios across centers)|Cochran-Mantel-Haenszel||||
1757712|NCT00220805|3228752|Superiority or Other|||||||0.49|||||||ANOVA|||The primary efficacy comparison for the change in LogMAR from baseline to endpoint was a two-way analysis of variance (ANOVA) with treatment group and center as fixed factors (main effect model).|
1757713|NCT00220779|3228753|Superiority or Other|||||||0.471||||||0.4 g/kg IGIV Group versus Placebo|Cochran-Mantel-Haenszel|||The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value > 0.05.|
1757714|NCT00220779|3228753|Superiority or Other|||||||0.221||||||0.2g/kg IGIV Group versus Placebo|Cochran-Mantel-Haenszel|||The primary efficacy comparison was the comparison of the proportions of relapse free subjects (relapse defined as reported, not necessarily confirmed relapse). The multiple test procedure (hierarchical procedure) was to be stopped as soon as one of the statistical tests resulted in a non-significant P value > 0.05.|
1757715|NCT00220740|3228756|Superiority or Other|||||||0.005|||||||ANCOVA|||Non-dominant hand|
1757716|NCT00220740|3228756|Superiority or Other||||||<|0.001|||||||ANCOVA|||Dominant hand|
1757717|NCT00220740|3228757|Superiority or Other|||||||0.542|||||||ANCOVA||||
1757718|NCT00220740|3228758|Superiority or Other||||||<|0.001|||||||Chi-squared|||The primary efficacy endpoint was the comparison of the Responder rates in the ITT population. Treatment group differences were tested by a Chi-square test. Subjects who did not complete the 24 week Efficacy Period and entered Rescue treatment with the alternative treatment were counted as Nonresponders.|
1757719|NCT00220701|3228769|Superiority or Other||F statistics|2.82||||0.1|2-Sided||||||Repeated Measures ANOVA||||
1757720|NCT00220636|3228770|Superiority or Other||t statistic|3.1||||0.008|2-Sided|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the BDI score pre- to post- treatment with aripiprazole.|
1757721|NCT00220636|3228771|Superiority or Other||t statistic|-3.1||||0.009|2-Sided|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the GAFS score pre- to post- treatment with aripiprazole.|
1757722|NCT00220636|3228773|Superiority or Other||t statistic|4.7|||<|0.001|2-Sided|95.0|||||t-test, 2 sided|df=13||Null hypothesis would be no change in the HDRS score pre- to post- treatment with aripiprazole.|
1757723|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|30.56|||||2-Sided|95.0|-1375.5|1436.61||||||For change in side effects at EoS, mean change difference was used to compare the two treatment groups.|
1757724|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|83.33|||||2-Sided|95.0|-283.46|450.13||||||For change in flatulence at EoS, mean change difference was used to compare the two treatment groups.|
1758320|NCT00205777|3229624|Superiority or Other|||||||0.012|||||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.|
1757726|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-733.59|733.59||||||For change in ascites at EoS, mean change difference was used to compare the two treatment groups.|
1757727|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|8.33|||||2-Sided|95.0|-175.06|191.73||||||For change in jaundice at EoS, mean change difference was used to compare the two treatment groups.|
1757728|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|83.33|||||2-Sided|95.0|-283.46|450.13||||||For change in altered bowel habits at EoS, mean change difference was used to compare the two treatment groups.|
1757729|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|25.0|||||2-Sided|95.0|-1258.79|1308.79||||||For change in eating related items at EoS, mean change difference was used to compare the two treatment groups.|
1757730|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|58.33|||||2-Sided|95.0|-491.86|608.53||||||For change in pancreatic pain at EoS, mean change difference was used to compare the two treatment groups.|
1757731|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-22.22|||||2-Sided|95.0|-275.19|230.75||||||For change in ability to plan future at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757732|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|44.44|||||2-Sided|95.0|-208.53|297.42||||||For change in side effects at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757733|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|38.89|||||2-Sided|95.0|-87.6|165.37||||||For change in cachexia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757734|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|11.11|||||2-Sided|95.0|-84.5|106.73||||||For change in flatulence at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757735|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|11.11|||||2-Sided|95.0|-84.5|106.73||||||For change in indigestion at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757736|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-11.11|||||2-Sided|95.0|-202.34|180.12||||||For change in ascites at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757737|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-733.59|733.59||||||For change in sexual functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757738|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|44.44|||||2-Sided|95.0|-82.04|170.93||||||For change in health care satisfaction at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757739|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|33.33|||||2-Sided|95.0|-185.75|252.41||||||For change in body image at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757740|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|100.0|||||2-Sided|95.0|-119.08|319.08||||||For change in jaundice at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757741|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|66.67|||||2-Sided|95.0|-152.41|285.75||||||For change in altered bowel habits at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757742|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|5.56|||||2-Sided|95.0|-260.62|271.74||||||For change in eating related items at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757743|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|13.89|||||2-Sided|95.0|-221.53|249.31||||||For change in pancreatic pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757744|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-117.07|117.07||||||For change in ability to plan future at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757745|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|25.93|||||2-Sided|95.0|-53.73|105.58||||||For change in side effects at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757746|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|8.33|||||2-Sided|95.0|-100.19|116.86||||||For change in cachexia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757747|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|16.67|||||2-Sided|95.0|-34.03|67.36||||||For change in flatulence at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757748|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|27.78|||||2-Sided|95.0|-41.89|97.45||||||For change in indigestion at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757749|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-33.33|||||2-Sided|95.0|-91.87|25.2||||||For change in ascites at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757750|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|20.0|||||2-Sided|95.0|-70.68|110.68||||||For change in sexual functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757751|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|47.22|||||2-Sided|95.0|-37.69|132.13||||||For change in health care satisfaction at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757752|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|25.0|||||2-Sided|95.0|-56.48|106.48||||||For change in body image at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757753|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|86.11|||||2-Sided|95.0|40.61|131.61||||||For change in jaundice at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757754|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|77.78|||||2-Sided|95.0|14.55|141.0||||||For change in altered bowel habits at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757755|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|25.0|||||2-Sided|95.0|-45.18|95.18||||||For change in eating related items at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757756|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|25.0|||||2-Sided|95.0|-45.18|95.18||||||For change in pancreatic pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757757|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-14.29|||||2-Sided|95.0|-125.23|96.66||||||For change in ability to plan future at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757758|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-50.0|||||2-Sided|95.0|-163.35|63.35||||||For change in fear of future health at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757759|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|31.75|||||2-Sided|95.0|-56.14|119.63||||||For change in side effects at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757760|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|23.81|||||2-Sided|95.0|-66.45|114.07||||||For change in cachexia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757761|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|14.29|||||2-Sided|95.0|-54.32|82.89||||||For change in flatulence at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757762|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|4.76|||||2-Sided|95.0|-88.45|97.98||||||For change in indigestion at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757763|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-44.44|||||2-Sided|95.0|-140.03|51.14||||||For change in ascites at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757764|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-13.33|||||2-Sided|95.0|-104.01|77.34||||||For change in sexual functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757765|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|35.71|||||2-Sided|95.0|-28.11|99.53||||||For change in health care satisfaction at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757766|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|28.57|||||2-Sided|95.0|-64.64|121.79||||||For change in body image at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757767|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|76.19|||||2-Sided|95.0|33.64|118.74||||||For change in jaundice at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757768|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|73.81|||||2-Sided|95.0|7.9|139.72||||||For change in altered bowel habits at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757769|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|14.29|||||2-Sided|95.0|-87.74|116.31||||||For change in eating related items at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757770|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|16.67|||||2-Sided|95.0|-62.93|96.26||||||For change in pancreatic pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757771|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-55.56|||||2-Sided|95.0|-212.46|101.35||||||For change in ability to plan future at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757772|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-29.17|||||2-Sided|95.0|-142.55|84.21||||||For change in fear of future health at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757773|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|11.11|||||2-Sided|95.0|-74.3|96.52||||||For change in side effects at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757774|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|27.78|||||2-Sided|95.0|-36.28|91.83||||||For change in cachexia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757775|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|22.22|||||2-Sided|95.0|-58.8|103.25||||||For change in flatulence at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757776|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-7.41|||||2-Sided|95.0|-104.79|89.97||||||For change in indigestion at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757777|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-3.7|||||2-Sided|95.0|-67.04|59.64||||||For change in ascites at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757778|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-7.14|||||2-Sided|95.0|-41.45|27.16||||||For change in sexual functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757779|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|37.04|||||2-Sided|95.0|-29.46|103.54||||||For change in health care satisfaction at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757780|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|5.56|||||2-Sided|95.0|-85.03|96.14||||||For change in body image at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757781|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|92.59|||||2-Sided|95.0|63.16|122.02||||||For change in jaundice at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757782|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|48.15|||||2-Sided|95.0|-7.12|103.42||||||For change in altered bowel habits at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757783|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-12.96|||||2-Sided|95.0|-130.69|104.76||||||For change in eating related items at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757784|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|23.46|||||2-Sided|95.0|-39.71|86.63||||||For change in pancreatic pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757785|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-18.52|||||2-Sided|95.0|-115.22|78.19||||||For change in ability to plan future at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757786|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|20.83|||||2-Sided|95.0|-44.95|86.62||||||For change in fear of future health at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757787|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|30.86|||||2-Sided|95.0|-16.16|77.89||||||For change in side effects at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757788|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|13.89|||||2-Sided|95.0|-32.71|60.49||||||For change in cachexia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757789|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|12.96|||||2-Sided|95.0|-40.45|66.37||||||For change in flatulence at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757790|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-7.41|||||2-Sided|95.0|-44.46|29.64||||||For change in indigestion at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757791|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|32.14|||||2-Sided|95.0|-2.09|66.37||||||For change in sexual functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757792|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|38.89|||||2-Sided|95.0|-5.05|82.83||||||For change in health care satisfaction at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757793|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|41.67|||||2-Sided|95.0|-36.0|119.34||||||For change in body image at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757794|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|47.22|||||2-Sided|95.0|7.31|87.13||||||For change in jaundice at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757795|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-19.44|||||2-Sided|95.0|-71.89|33.0||||||For change in altered bowel habits at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757796|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-23.15|||||2-Sided|95.0|-76.41|30.11||||||For change in eating related items at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757797|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|12.96|||||2-Sided|95.0|-24.52|50.45||||||For change in pancreatic pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757798|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-4.17|||||2-Sided|95.0|-69.9|61.57||||||For change in ability to plan future at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757799|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-4.44|||||2-Sided|95.0|-53.14|44.25||||||For change in fear of future health at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757800|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|38.56|||||2-Sided|95.0|5.32|71.81||||||For change in side effects at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757801|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|25.74|||||2-Sided|95.0|-8.22|59.69||||||For change in cachexia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757802|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|10.29|||||2-Sided|95.0|-20.12|40.71||||||For change in flatulence at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757803|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|20.59|||||2-Sided|95.0|-17.94|59.12||||||For change in indigestion at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757804|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|6.37|||||2-Sided|95.0|-24.04|36.79||||||For change in ascites at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757805|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|13.14|||||2-Sided|95.0|-29.46|55.74||||||For change in sexual functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757806|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|13.54|||||2-Sided|95.0|-32.7|59.78||||||For change in health care satisfaction at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757807|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|23.96|||||2-Sided|95.0|-9.93|57.84||||||For change in body image at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757808|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|18.63|||||2-Sided|95.0|-5.64|42.89||||||For change in jaundice at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757809|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|22.06|||||2-Sided|95.0|-7.93|52.05||||||For change in altered bowel habits at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757810|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-13.24|||||2-Sided|95.0|-68.52|42.05||||||For change in eating related items at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757811|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|8.74|||||2-Sided|95.0|-20.62|38.1||||||For change in pancreatic pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757812|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|31.11|||||2-Sided|95.0|1.6|60.62||||||For change in ability to plan future at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757813|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-14.81|||||2-Sided|95.0|-41.91|12.28||||||For change in fear of future health at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757814|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|21.77|||||2-Sided|95.0|1.11|42.43||||||For change in side effects at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757815|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|15.81|||||2-Sided|95.0|-10.43|42.06||||||For change in cachexia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757816|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|9.78|||||2-Sided|95.0|-15.33|34.89||||||For change in flatulence at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757817|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|22.08|||||2-Sided|95.0|-5.39|49.55||||||For change in indigestion at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757818|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|5.98|||||2-Sided|95.0|-17.02|28.99||||||For change in ascites at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757819|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-3.61|||||2-Sided|95.0|-21.78|14.57||||||For change in sexual functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757820|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-10.07|||||2-Sided|95.0|-47.95|27.8||||||For change in health care satisfaction at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757821|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|25.11|||||2-Sided|95.0|-0.16|50.38||||||For change in body image at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757822|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|24.22|||||2-Sided|95.0|5.09|43.34||||||For change in jaundice at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757823|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|28.28|||||2-Sided|95.0|4.23|52.32||||||For change in altered bowel habits at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757824|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|7.41|||||2-Sided|95.0|-25.22|40.03||||||For change in eating related items at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757825|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|11.25|||||2-Sided|95.0|-10.09|32.59||||||For change in pancreatic pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757826|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|15.38|||||2-Sided|95.0|-20.24|51.01||||||For change in ability to plan future at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757827|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-7.91|||||2-Sided|95.0|-36.18|20.37||||||For change in fear of future health at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757828|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|15.12|||||2-Sided|95.0|-3.23|33.46||||||For change in side effects at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757829|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|13.04|||||2-Sided|95.0|-5.73|31.81||||||For change in cachexia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757830|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|3.71|||||2-Sided|95.0|-20.37|27.8||||||For change in flatulence at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757831|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-6.96|||||2-Sided|95.0|-30.62|16.7||||||For change in indigestion at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757832|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-9.46|||||2-Sided|95.0|-27.48|8.56||||||For change in ascites at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757833|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-2.53|||||2-Sided|95.0|-26.55|21.5||||||For change in sexual functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757834|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|7.05|||||2-Sided|95.0|-23.23|37.34||||||For change in health care satisfaction at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757835|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|3.85|||||2-Sided|95.0|-16.45|24.14||||||For change in body image at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757836|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|12.84|||||2-Sided|95.0|-0.18|25.85||||||For change in jaundice at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757837|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|12.25|||||2-Sided|95.0|-10.33|34.82||||||For change in altered bowel habits at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757838|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-12.6|||||2-Sided|95.0|-32.86|7.66||||||For change in eating related items at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757839|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-4.19|||||2-Sided|95.0|-21.57|13.19||||||For change in pancreatic pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757840|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|21.51|||||2-Sided|95.0|-3.1|46.12||||||For change in ability to plan future at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757841|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-0.63|||||2-Sided|95.0|-23.7|22.43||||||For change in fear of future health at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757842|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|19.19|||||2-Sided|95.0|2.99|35.39||||||For change in side effects at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757843|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|9.27|||||2-Sided|95.0|-4.4|22.93||||||For change in cachexia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757844|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|3.4|||||2-Sided|95.0|-17.33|24.13||||||For change in flatulence at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757845|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|11.05|||||2-Sided|95.0|-10.65|32.75||||||For change in indigestion at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757846|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|1.54|||||2-Sided|95.0|-14.7|17.78||||||For change in ascites at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757847|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|1.32|||||2-Sided|95.0|-14.63|17.27||||||For change in sexual functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757848|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-10.61|||||2-Sided|95.0|-32.4|11.17||||||For change in health care satisfaction at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757849|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|18.72|||||2-Sided|95.0|0.49|36.95||||||For change in body image at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757850|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|11.57|||||2-Sided|95.0|0.66|22.48||||||For change in jaundice at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757851|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|18.86|||||2-Sided|95.0|0.17|37.55||||||For change in altered bowel habits at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757852|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|13.49|||||2-Sided|95.0|-7.45|34.42||||||For change in eating related items at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757853|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|14.87|||||2-Sided|95.0|0.79|28.94||||||For change in pancreatic pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1757854|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|6.21|||||2-Sided|95.0|-11.78|24.2||||||For change in ability to plan future at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757855|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-2.33|||||2-Sided|95.0|-16.36|11.71||||||For change in fear of future health at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757856|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|10.88|||||2-Sided|95.0|1.36|20.39||||||For change in side effects at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757857|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|12.5|||||2-Sided|95.0|2.78|22.22||||||For change in cachexia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757858|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|14.39|||||2-Sided|95.0|-1.61|30.4||||||For change in flatulence at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757859|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|5.95|||||2-Sided|95.0|-9.59|21.5||||||For change in indigestion at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757860|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-7.82|||||2-Sided|95.0|-25.04|9.4||||||For change in ascites at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757861|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|-21.19|||||2-Sided|95.0|-37.53|-4.85||||||For change in sexual functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757862|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|4.36|||||2-Sided|95.0|-14.59|23.3||||||For change in health care satisfaction at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757863|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|15.1|||||2-Sided|95.0|1.28|28.91||||||For change in body image at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757864|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|12.7|||||2-Sided|95.0|0.93|24.47||||||For change in jaundice at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757865|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|19.7|||||2-Sided|95.0|5.96|33.43||||||For change in altered bowel habits at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757866|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|3.41|||||2-Sided|95.0|-13.39|20.2||||||For change in eating related items at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757867|NCT00219557|3228774|Superiority or Other||Mean Difference (Final Values)|2.59|||||2-Sided|95.0|-10.11|15.29||||||For change in pancreatic pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1757868|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-16.67|||||2-Sided|95.0|-383.46|350.13||||||For change in financial difficulties at EoS, mean change difference was used to compare the two treatment groups.|
1757869|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|33.33|||||2-Sided|95.0|-700.26|766.93||||||For change in diarrhea at EoS, mean change difference was used to compare the two treatment groups.|
1757870|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-16.67|||||2-Sided|95.0|-1850.65|1817.32||||||For change in constipation at EoS, mean change difference was used to compare the two treatment groups.|
1757871|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|50.0|||||2-Sided|95.0|-1050.39|1150.39||||||For change in appetite loss at EoS, mean change difference was used to compare the two treatment groups.|
1757872|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|33.33|||||2-Sided|95.0|-700.26|766.93||||||For change in insomnia at EoS, mean change difference was used to compare the two treatment groups.|
1757873|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|83.33|||||2-Sided|95.0|-283.46|450.13||||||For change in dyspnea at EoS, mean change difference was used to compare the two treatment groups.|
1757874|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|25.0|||||2-Sided|95.0|-1258.79|1308.79||||||For change in pain at EoS, mean change difference was used to compare the two treatment groups.|
1757875|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|33.33|||||2-Sided|95.0|-333.46|400.13||||||For change in nausea and vomiting at EoS, mean change difference was used to compare the two treatment groups.|
1758381|NCT00205777|3229638|Superiority or Other|||||||0.1|||||||ANOVA||||
1757876|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|66.67|||||2-Sided|95.0|-177.86|311.2||||||For change in fatigue at EoS, mean change difference was used to compare the two treatment groups.|
1757877|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-83.33|||||2-Sided|95.0|-450.13|283.46||||||For change in social functioning at EoS, mean change difference was used to compare the two treatment groups.|
1757878|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-66.67|||||2-Sided|95.0|-66.67|-66.67||||||For change in cognitive functioning at EoS, mean change difference was used to compare the two treatment groups.|
1757879|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-41.67|||||2-Sided|95.0|-591.86|508.53||||||For change in emotional functioning at EoS, mean change difference was used to compare the two treatment groups.|
1757880|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-33.33|||||2-Sided|95.0|-400.13|333.46||||||For change in role functioning at EoS, mean change difference was used to compare the two treatment groups.|
1757881|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-70.0|||||2-Sided|95.0|-143.36|3.36||||||For change in physical functioning at EoS, mean change difference was used to compare the two treatment groups.|
1757882|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-54.17|||||2-Sided|95.0|-512.66|404.33||||||For change in global QoL at EoS, mean change difference was used to compare the two treatment groups.|
1757883|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-11.11|||||2-Sided|95.0|-106.73|84.5||||||For change in financial difficulties at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757884|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|77.78|||||2-Sided|95.0|-17.84|173.39||||||For change in diarrhea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757885|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-165.61|165.61||||||For change in constipation at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757886|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|44.44|||||2-Sided|95.0|-208.53|297.42||||||For change in appetite loss at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757887|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|22.22|||||2-Sided|95.0|-322.52|366.97||||||For change in insomnia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757888|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-11.11|||||2-Sided|95.0|-355.85|333.63||||||For change in dyspnea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757889|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|38.89|||||2-Sided|95.0|-305.85|383.63||||||For change in pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757890|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|11.11|||||2-Sided|95.0|-302.38|324.6||||||For change in nausea and vomiting at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757891|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|14.81|||||2-Sided|95.0|-215.01|244.64||||||For change in fatigue at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757892|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|27.78|||||2-Sided|95.0|-238.4|293.96||||||For change in social functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757893|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|5.56|||||2-Sided|95.0|-307.94|319.05||||||For change in cognitive functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757894|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-16.67|||||2-Sided|95.0|-275.22|241.89||||||For change in emotional functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757895|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|27.78|||||2-Sided|95.0|-238.4|293.96||||||For change in role functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757896|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|15.56|||||2-Sided|95.0|-166.87|197.98||||||For change in physical functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757897|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-5.56|||||2-Sided|95.0|-271.74|260.62||||||For change in global QoL at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.|
1757898|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-4.76|||||2-Sided|95.0|-64.93|55.41||||||For change in financial difficulties at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757899|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|76.19|||||2-Sided|95.0|-6.75|159.13||||||For change in diarrhea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757900|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-19.05|||||2-Sided|95.0|-117.92|79.82||||||For change in constipation at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757901|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-9.52|||||2-Sided|95.0|-129.86|110.82||||||For change in appetite loss at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757902|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|4.76|||||2-Sided|95.0|-55.41|64.93||||||For change in insomnia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757903|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-11.11|||||2-Sided|95.0|-86.68|64.46||||||For change in dyspnea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757904|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-4.76|||||2-Sided|95.0|-97.98|88.45||||||For change in pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757905|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-16.67|||||2-Sided|95.0|-83.26|49.93||||||For change in nausea and vomiting at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1758382|NCT00205777|3229638|Superiority or Other|||||||0.25|||||||ANOVA||||
1757906|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-30.16|||||2-Sided|95.0|-94.53|34.21||||||For change in fatigue at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757907|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|28.57|||||2-Sided|95.0|-53.82|110.96||||||For change in social functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757908|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|23.81|||||2-Sided|95.0|-31.66|79.28||||||For change in cognitive functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757909|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-3.57|||||2-Sided|95.0|-63.74|56.6||||||For change in emotional functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757910|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|26.19|||||2-Sided|95.0|-29.28|81.66||||||For change in role functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757911|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|27.62|||||2-Sided|95.0|-6.42|61.66||||||For change in physical functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757912|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|16.67|||||2-Sided|95.0|-39.62|72.95||||||For change in global QoL at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.|
1757913|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-4.17|||||2-Sided|95.0|-57.74|49.41||||||For change in financial difficulties at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757914|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|79.17|||||2-Sided|95.0|-29.72|188.06||||||For change in diarrhea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757915|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-8.33|||||2-Sided|95.0|-105.73|89.06||||||For change in constipation at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757916|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-25.0|||||2-Sided|95.0|-184.57|134.57||||||For change in appetite loss at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757917|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-4.17|||||2-Sided|95.0|-87.02|78.69||||||For change in insomnia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757918|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-14.29|||||2-Sided|95.0|-82.89|54.32||||||For change in dyspnea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757919|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-77.4|77.4||||||For change in pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757920|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-25.0|||||2-Sided|95.0|-69.69|19.69||||||For change in nausea and vomiting at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757921|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-15.28|||||2-Sided|95.0|-99.46|68.9||||||For change in fatigue at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757922|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|27.08|||||2-Sided|95.0|-91.02|145.18||||||For change in social functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757923|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|31.25|||||2-Sided|95.0|-40.94|103.44||||||For change in cognitive functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757924|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|5.21|||||2-Sided|95.0|-28.19|38.61||||||For change in emotional functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757925|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|4.17|||||2-Sided|95.0|-58.04|66.37||||||For change in role functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757926|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|33.33|||||2-Sided|95.0|-17.22|83.89||||||For change in physical functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757927|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|15.62|||||2-Sided|95.0|-74.75|106.0||||||For change in global QoL at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.|
1757928|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-3.33|||||2-Sided|95.0|-48.23|41.56||||||For change in financial difficulties at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757929|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|73.33|||||2-Sided|95.0|-16.45|163.12||||||For change in diarrhea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757930|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-3.33|||||2-Sided|95.0|-72.58|65.91||||||For change in constipation at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757931|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-36.67|||||2-Sided|95.0|-151.27|77.94||||||For change in appetite loss at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757932|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-20.0|||||2-Sided|95.0|-133.08|93.08||||||For change in insomnia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757933|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-18.52|||||2-Sided|95.0|-89.98|52.94||||||For change in dyspnea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757934|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|8.33|||||2-Sided|95.0|-79.59|96.26||||||For change in pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757935|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-16.67|||||2-Sided|95.0|-62.33|28.99||||||For change in nausea and vomiting at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757936|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-17.78|||||2-Sided|95.0|-77.63|42.08||||||For change in fatigue at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757937|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|5.0|||||2-Sided|95.0|-76.36|86.36||||||For change in social functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757938|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|16.67|||||2-Sided|95.0|-36.06|69.39||||||For change in cognitive functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757939|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-7.5|||||2-Sided|95.0|-51.66|36.66||||||For change in emotional functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757940|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|20.0|||||2-Sided|95.0|-35.3|75.3||||||For change in role functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757941|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|9.33|||||2-Sided|95.0|-44.54|63.2||||||For change in physical functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757942|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|20.83|||||2-Sided|95.0|-58.94|100.6||||||For change in global QoL at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.|
1757943|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-6.67|||||2-Sided|95.0|-34.3|20.96||||||For change in financial difficulties at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757944|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|3.33|||||2-Sided|95.0|-34.92|41.58||||||For change in diarrhea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757945|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|53.33|||||2-Sided|95.0|-18.6|125.26||||||For change in constipation at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757946|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-32.22|||||2-Sided|95.0|-115.58|51.13||||||For change in appetite loss at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757947|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-21.11|||||2-Sided|95.0|-73.14|30.92||||||For change in insomnia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757948|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-16.67|||||2-Sided|95.0|-53.79|20.46||||||For change in dyspnea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757949|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|7.78|||||2-Sided|95.0|-41.75|57.3||||||For change in pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757950|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-15.0|||||2-Sided|95.0|-43.1|13.1||||||For change in nausea and vomiting at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757951|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-17.04|||||2-Sided|95.0|-58.87|24.79||||||For change in fatigue at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757952|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|10.0|||||2-Sided|95.0|-57.71|77.71||||||For change in social functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757953|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|7.22|||||2-Sided|95.0|-24.98|39.43||||||For change in cognitive functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757954|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-0.93|||||2-Sided|95.0|-22.59|20.74||||||For change in emotional functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757955|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-48.33|||||2-Sided|95.0|-111.94|15.28||||||For change in role functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757956|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|18.89|||||2-Sided|95.0|-20.74|58.52||||||For change in physical functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757957|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|12.04|||||2-Sided|95.0|-39.03|63.11||||||For change in global QoL at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.|
1757958|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|23.98|||||2-Sided|95.0|1.09|46.86||||||For change in financial difficulties at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757959|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-1.75|||||2-Sided|95.0|-39.1|35.59||||||For change in diarrhea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757960|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|22.81|||||2-Sided|95.0|-22.61|68.22||||||For change in constipation at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757961|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|13.16|||||2-Sided|95.0|-71.22|97.54||||||For change in appetite loss at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757962|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|9.65|||||2-Sided|95.0|-37.43|56.73||||||For change in insomnia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757963|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-1.85|||||2-Sided|95.0|-38.65|34.94||||||For change in dyspnea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757964|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|24.56|||||2-Sided|95.0|-13.08|62.2||||||For change in pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757965|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|3.95|||||2-Sided|95.0|-30.84|38.73||||||For change in nausea and vomiting at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757966|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|23.39|||||2-Sided|95.0|-15.83|62.61||||||For change in fatigue at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757967|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|14.04|||||2-Sided|95.0|-20.97|49.04||||||For change in social functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757968|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-11.99|||||2-Sided|95.0|-35.46|11.48||||||For change in cognitive functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757969|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-6.14|||||2-Sided|95.0|-26.59|14.31||||||For change in emotional functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757970|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-26.32|||||2-Sided|95.0|-71.87|19.24||||||For change in role functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757971|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-12.98|||||2-Sided|95.0|-52.01|26.04||||||For change in physical functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.|
1757972|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-8.66|||||2-Sided|95.0|-34.53|17.21||||||For change in global QoL at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups|
1757973|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-23.38|23.38||||||For change in financial difficulties at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757974|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|11.9|||||2-Sided|95.0|-16.13|39.94||||||For change in diarrhea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757975|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|11.9|||||2-Sided|95.0|-19.02|42.83||||||For change in constipation at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757976|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|20.83|||||2-Sided|95.0|-13.98|55.65||||||For change in appetite loss at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757977|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|10.12|||||2-Sided|95.0|-18.49|38.73||||||For change in insomnia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757978|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|22.02|||||2-Sided|95.0|0.38|43.66||||||For change in dyspnea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757979|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|19.64|||||2-Sided|95.0|-7.12|46.41||||||For change in pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757980|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|6.25|||||2-Sided|95.0|-13.49|25.99||||||For change in nausea and vomiting at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757981|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|25.0|||||2-Sided|95.0|3.23|46.77||||||For change in fatigue at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757982|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-20.24|||||2-Sided|95.0|-47.93|7.46||||||For change in social functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757983|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-9.52|||||2-Sided|95.0|-29.66|10.61||||||For change in cognitive functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757984|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-24.11|||||2-Sided|95.0|-42.72|-5.5||||||For change in emotional functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757985|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-16.07|||||2-Sided|95.0|-41.1|8.96||||||For change in role functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757986|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-8.57|||||2-Sided|95.0|-27.24|10.1||||||For change in physical functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757987|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-20.01|||||2-Sided|95.0|-43.19|3.17||||||For change in global QoL at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.|
1757988|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|9.48|||||2-Sided|95.0|-5.89|24.86||||||For change in financial difficulties at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757989|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|1.97|||||2-Sided|95.0|-24.07|28.01||||||For change in diarrhea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757990|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|0.56|||||2-Sided|95.0|-25.71|26.82||||||For change in constipation at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757991|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|9.03|||||2-Sided|95.0|-15.26|33.32||||||For change in appetite loss at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757992|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-6.33|||||2-Sided|95.0|-26.25|13.59||||||For change in insomnia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757993|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|5.13|||||2-Sided|95.0|-14.18|24.44||||||For change in dyspnea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757994|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-5.13|||||2-Sided|95.0|-24.26|14.0||||||For change in pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757995|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-11.1|||||2-Sided|95.0|-24.11|1.91||||||For change in nausea and vomiting at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757996|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|10.88|||||2-Sided|95.0|-5.86|27.63||||||For change in fatigue at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757997|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-7.09|||||2-Sided|95.0|-30.48|16.31||||||For change in social functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757998|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-6.99|||||2-Sided|95.0|-23.13|9.15||||||For change in cognitive functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1757999|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-12.25|||||2-Sided|95.0|-26.5|2.0||||||For change in emotional functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1758000|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-17.53|||||2-Sided|95.0|-39.11|4.05||||||For change in role functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1758001|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-5.64|||||2-Sided|95.0|-19.75|8.46||||||For change in physical functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1758002|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-5.97|||||2-Sided|95.0|-19.52|7.57||||||For change in global QoL at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.|
1758003|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|5.56|||||2-Sided|95.0|-9.81|20.92||||||For change in financial difficulties at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758004|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|2.87|||||2-Sided|95.0|-16.29|22.03||||||For change in diarrhea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758005|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|2.76|||||2-Sided|95.0|-17.49|23.02||||||For change in constipation at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758006|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|16.24|||||2-Sided|95.0|-7.62|40.1||||||For change in appetite loss at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758007|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|1.59|||||2-Sided|95.0|-20.19|23.36||||||For change in insomnia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758008|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|10.39|||||2-Sided|95.0|-5.68|26.47||||||For change in dyspnea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758009|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|16.59|||||2-Sided|95.0|-3.22|36.39||||||For change in pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758010|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-1.8|||||2-Sided|95.0|-18.78|15.18||||||For change in nausea and vomiting at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758011|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|16.14|||||2-Sided|95.0|-1.27|33.54||||||For change in fatigue at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758012|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-9.62|||||2-Sided|95.0|-28.28|9.04||||||For change in social functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758013|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-7.1|||||2-Sided|95.0|-20.97|6.77||||||For change in cognitive functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758014|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-13.92|||||2-Sided|95.0|-29.16|1.32||||||For change in emotional functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758015|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-18.65|||||2-Sided|95.0|-35.47|-1.83||||||For change in role functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758016|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-11.58|||||2-Sided|95.0|-24.12|0.96||||||For change in physical functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758017|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-15.83|||||2-Sided|95.0|-32.34|0.67||||||For change in global QoL at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.|
1758018|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|5.43|||||2-Sided|95.0|-4.67|15.53||||||For change in financial difficulties at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758019|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-1.28|||||2-Sided|95.0|-15.1|12.54||||||For change in diarrhea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758020|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|4.67|||||2-Sided|95.0|-11.62|20.96||||||For change in constipation at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758021|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|13.63|||||2-Sided|95.0|-4.81|32.07||||||For change in appetite loss at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758022|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|9.9|||||2-Sided|95.0|-5.7|25.49||||||For change in insomnia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758023|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|12.51|||||2-Sided|95.0|-1.28|26.3||||||For change in dyspnea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758024|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|7.37|||||2-Sided|95.0|-7.57|22.32||||||For change in pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758025|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-4.3|||||2-Sided|95.0|-16.55|7.96||||||For change in nausea and vomiting at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758026|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|10.41|||||2-Sided|95.0|-1.62|22.44||||||For change in fatigue at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758027|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-3.33|||||2-Sided|95.0|-18.72|12.06||||||For change in social functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758028|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-5.11|||||2-Sided|95.0|-15.83|5.61||||||For change in cognitive functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758029|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-4.73|||||2-Sided|95.0|-15.25|5.79||||||For change in emotional functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758030|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-9.32|||||2-Sided|95.0|-23.77|5.12||||||For change in role functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758031|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-6.02|||||2-Sided|95.0|-15.4|3.36||||||For change in physical functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758032|NCT00219557|3228775|Superiority or Other||Mean Difference (Final Values)|-8.44|||||2-Sided|95.0|-19.06|2.19||||||For change in global QoL at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.|
1758033|NCT00219557|3228777|Superiority or Other||Hazard Ratio (HR)|0.9648||||0.4466|2-Sided|95.0|0.54|1.73||One-sided log-rank test at alpha = 0.1 significance level was used.|Log Rank|||Differences in PFS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are ECOG performance status (less than equal to 1 or 2) and extent of disease (locally advanced or metastatic).|
1758034|NCT00219557|3228779|Superiority or Other||Difference in response rate|4.3||||0.661|2-Sided|95.0|-4.0|12.7|||Fisher Exact|||Difference in percent of participants with overall response expressed as response rate, was used for calculation of 95% confidence interval (CI).|
1758035|NCT00219557|3228790|Superiority or Other||Hazard Ratio (HR)|0.758||||0.1026|2-Sided|95.0|0.49|1.17||One-sided log-rank test at alpha = 0.1 significance level was used.|Log Rank|||Differences in OS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to 1 or 2) and extent of disease (locally advanced or metastatic).|
1758036|NCT00219544|3228791|Superiority or Other||Mean Difference (Net)|2.07|Standard Error of the Mean|2.54||0.418||95.0|-2.96|7.1|||ANCOVA|() , )|pregabalin minus placebo|Visual Analog Scale|
1758037|NCT00219544|3228791|Superiority or Other||Mean Difference (Net)|0.05|Standard Error of the Mean|0.03||0.0719||95.0|0.0|0.11|||ANCOVA|() , )|pregabalin minus placebo|Health State Profile|
1758038|NCT00219544|3228792|Superiority or Other||Mean Difference (Net)|-0.77|Standard Error of the Mean|0.26||0.0037||95.0|-1.29|-0.25|||ANCOVA|||Pain severity|
1758039|NCT00219544|3228792|Superiority or Other||Mean Difference (Net)|-0.76|Standard Error of the Mean|0.26||0.0049||95.0|-1.28|-0.23|||ANCOVA|||Pain interference|
1758040|NCT00219544|3228793|Superiority or Other|||||||0.0278|||||||Mantel Haenszel|||The distribution of the responses to the PGIC at EOT was compared between the 2 treatment groups using the 7 categories of the PGIC.|
1758041|NCT00219544|3228794|Superiority or Other||Mean Difference (Net)|6.49|Standard Error of the Mean|2.75||0.0197||95.0|1.05|11.94|||ANCOVA||pregabalin minus placebo|Satisfaction|
1758042|NCT00219544|3228794|Superiority or Other||Mean Difference (Net)|5.98|Standard Error of the Mean|3.42||0.0828||95.0|-0.79|12.75|||ANCOVA||pregabalin minus placebo|Impact|
1758043|NCT00219544|3228795|Superiority or Other||Mean Difference (Net)|-1.2|Standard Error of the Mean|0.4||0.0013||95.0|-1.9|-0.5|||ANCOVA||pregabalin minus placebo|HADS-D|
1758044|NCT00219544|3228795|Superiority or Other||Mean Difference (Net)|-1.3|Standard Error of the Mean|0.4||0.0023||95.0|-2.1|-0.5|||ANCOVA||pregabalin minus placebo|HADS-A|
1758045|NCT00219544|3228796|Superiority or Other||Mean Difference (Net)|-9.0|Standard Error of the Mean|3.3||0.0069||95.0|-15.5|-2.5|||ANCOVA||||
1758046|NCT00219544|3228797|Superiority or Other||Mean Difference (Net)|-0.74|Standard Error of the Mean|0.22||0.0011||95.0|-1.18|-0.3|||ANCOVA||pregabalin minus placebo|Week 9|
1758047|NCT00219544|3228797|Superiority or Other||Mean Difference (Net)|-0.85|Standard Error of the Mean|0.23||0.0003||95.0|-1.31|-0.39|||ANCOVA||pregabalin minus placebo|Week 8|
1758048|NCT00219544|3228797|Superiority or Other||Mean Difference (Net)|-0.82|Standard Error of the Mean|0.23||0.0005||95.0|-1.28|-0.36|||ANCOVA||pregabalin minus placebo|Week 7|
1758049|NCT00219544|3228797|Superiority or Other||Mean Difference (Net)|-0.87|Standard Error of the Mean|0.22|<|0.0001||95.0|-1.31|-0.44|||ANCOVA||pregabalin minus placebo|Week 6|
1758050|NCT00219544|3228797|Superiority or Other||Mean Difference (Net)|-0.52|Standard Error of the Mean|0.22|<|0.0177||95.0|-0.94|-0.09|||ANCOVA||pregabalin minus placebo|Week 5|
1758051|NCT00219544|3228800|Superiority or Other||Median Difference (Net)|-0.71|Standard Error of the Mean|0.24||0.0031||95.0|-1.18|-0.24|||ANCOVA||||
1758052|NCT00219544|3228806|Superiority or Other||Mean Difference (Net)|-0.69|Standard Error of the Mean|0.23||0.0022||95.0|-1.14|-0.25|||ANCOVA||pregabalin minus placebo|Week 9|
1758053|NCT00219544|3228806|Superiority or Other||Mean Difference (Net)|-0.93|Standard Error of the Mean|0.23|<|0.0001||95.0|-1.39|-0.47|||ANCOVA||pregabalin minus placebo|Week 8|
1758054|NCT00219544|3228806|Superiority or Other||Mean Difference (Net)|-0.93|Standard Error of the Mean|0.23|<|0.0001||95.0|-1.39|-0.47|||ANCOVA||pregabalin minus placebo|Week 7|
1758055|NCT00219544|3228806|Superiority or Other||Mean Difference (Net)|-0.97|Standard Error of the Mean|0.22|<|0.0001||95.0|-1.41|-0.53|||ANCOVA||pregabalin minus placebo|Week 6|
1758056|NCT00219544|3228806|Superiority or Other||Mean Difference (Net)|-0.72|Standard Error of the Mean|0.22|<|0.001||95.0|-1.15|-0.3|||ANCOVA||pregabalin minus placebo|Week 5|
1758079|NCT00216671|3228939|Superiority or Other||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).|
1758057|NCT00219544|3228809|Superiority or Other||Mean Difference (Net)|-0.78|Standard Error of the Mean|0.25||0.0018||95.0|-1.27|-0.3|||ANCOVA||Difference = pregabalin minus placebo|The study is powered to detect clinically significant difference of 1.2 between treatment groups in mean pain score at end of treatment. The statistical sample size calculation requires a total of 144 subjects to complete the Double-Blind phase of the study: a sample size of 72 in each treatment group will have 90% power to detect a difference in treatment mean pain scores of 1.2 assuming that the common standard deviation is 2.2 using a two group t-test with a 0.05 two-sided significance level.|
1758058|NCT00218634|3228844|Superiority or Other||||||<|0.05||||||CD4 would be more improved in the treatment condition|HLM|||follow up analysis revealed that CD4, over time, significantly improved over control when covarying out baseline levels.|
1758059|NCT00218634|3228846|Superiority or Other||||||<|0.05||||||GLM - CBT-AD would be superior to ETAU at post. HLM - CBT-AD would be superior to CBT-AD at follow ups.|GLM and HLM||||
1758060|NCT00218634|3228847|Superiority or Other||||||<|0.05|||||||HLM|||We used HLM with weekly visit data for the acute outcome. There were, therefore, 11 time points used.|
1758061|NCT00218439|3228854|Superiority or Other (legacy)|||||||0.82|||||||Mixed Models Analysis||||
1758062|NCT00218439|3228855|Superiority or Other (legacy)|||||||0.33|||||||Mixed Models Analysis||||
1758063|NCT00218439|3228856|Superiority or Other (legacy)|||||||0.56|||||||Mixed Models Analysis||||
1758064|NCT00218439|3228857|Superiority or Other (legacy)|||||||0.006|||||||Mixed Models Analysis||||
1758065|NCT00218439|3228858|Superiority or Other (legacy)||||||<|0.001|||||||Mixed Models Analysis||||
1758066|NCT00218296|3228887|Superiority or Other||Odds Ratio (OR)|0.09||||0.002|2-Sided|95.0|0.004|0.48||There were no adjustments in the analysis.|Chi-squared||The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.|
1758067|NCT00218296|3228888|Superiority or Other||Odds Ratio (OR)|0.47||||0.056|2-Sided|95.0|0.2|1.03|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.|
1758068|NCT00218296|3228889|Superiority or Other||Odds Ratio (OR)|0.09||||0.002|2-Sided|95.0|0.004|0.48|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care Condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.|
1758069|NCT00218296|3228890|Superiority or Other||Odds Ratio (OR)|0.42||||0.03|2-Sided|95.0|0.18|0.94|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.|
1758070|NCT00218296|3228891|Superiority or Other||Odds Ratio (OR)|0.28||||0.019|2-Sided|95.0|0.07|0.83|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the Usual Care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.|
1758071|NCT00218296|3228892|Superiority or Other||Odds Ratio (OR)|0.51||||0.04|2-Sided|95.0|0.26|0.99|||Chi-squared|There were no adjustments in the analysis.|The reference group for the odds ratio estimate is the usual care condition, i.e., the immediate cessation condition.|The null hypothesis was that the Usual Care Group (i.e. the immediate cessation group) and the Reduction Group had the same cessation rate. The alternative hypothesis was that they had different cessation rates. Two-sided test with a type I error of 0.05 was used.|
1758072|NCT00217087|3228930|Superiority or Other|||||||0.2|||||||Chi-squared|the only participant who reported a decrease quality of life related that to a recent surgery not their esophagus.|||
1758073|NCT00217087|3228931|Superiority or Other|||||||0.34|||||||Chi-squared||||
1758074|NCT00217087|3228932|Superiority or Other|||||||0.0098|||||||Fisher Exact||||
1758075|NCT00216671|3228939|Superiority or Other||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).|
1758076|NCT00216671|3228939|Superiority or Other||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).|
1758077|NCT00216671|3228939|Superiority or Other||||||<|0.721||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in SF-12 MCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).|
1758078|NCT00216671|3228939|Superiority or Other||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).|
1758080|NCT00216671|3228939|Superiority or Other||||||<|0.519||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in SF-12 PCS score from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).|
1758081|NCT00216671|3228940|Superiority or Other||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).|
1758082|NCT00216671|3228940|Superiority or Other||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).|
1758083|NCT00216671|3228940|Superiority or Other||||||<|0.798||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in GAF from baseline to endpoint. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).|
1758084|NCT00216671|3228941|Superiority or Other||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.|
1758085|NCT00216671|3228941|Superiority or Other||||||<|0.001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon-signed-rank test|||Within-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.|
1758086|NCT00216671|3228941|Superiority or Other||||||<|0.8||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon two sample test|||Between-group comparison of the change in CGI-S from baseline to endpoint was analyzed as is with no derived calculations. CGI-S scores were coded as follows: 0=normal, not at all ill, 1=borderline, etc. and 6=among the most extremely ill patients.The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).|
1758087|NCT00216671|3228944|Non-Inferiority or Equivalence|Non-inferiority of early initiation was inferred if the upper 95% confidence boundary for the difference of change in PANSS total score from baseline in favor of the routine approach is less than 6.|Mean Difference (Net)|-1.13|Standard Error of the Mean|4.1||0.784|2-Sided|95.0|-9.24|6.99||An ANCOVA model with treatment as factor was used. The comparison between the 2 treatment groups was performed based on the least-squares means obtained from the ANCOVA model.|ANCOVA|||Assuming a difference of 3 points in favor of early initiation of treatment with Risperdal Consta, a sample size of 87 subjects per treatment arm has a power of 80% to demonstrate non-inferiority at the 0.025-level (1-sided). It was expected that about 20% of randomized subjects had to be excluded from the per-protocol (PP) analysis. Therefore, 220 subjects were to be included.|
1758088|NCT00216476|3228945|Superiority or Other||||||<|0.0001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.|
1758089|NCT00216476|3228945|Superiority or Other||||||<|0.0001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.|
1758090|NCT00216476|3228945|Superiority or Other||||||<|0.5589||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in MCS score. The endpoint of the study was based on the LOCF principle.|
1758091|NCT00216476|3228945|Superiority or Other||||||<|0.1146||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.|
1758092|NCT00216476|3228945|Superiority or Other||||||<|0.0001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.|
1758093|NCT00216476|3228945|Superiority or Other||||||<|0.0941||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in PCS score. The endpoint of the study was based on the LOCF principle.|
1758094|NCT00216476|3228946|Superiority or Other|||||||0.0446||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.|
1758095|NCT00216476|3228946|Superiority or Other||||||<|0.0001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.|
1758096|NCT00216476|3228946|Superiority or Other||||||<|0.0001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in CGI-S score. The endpoint of the study was based on the LOCF principle.|
1758097|NCT00216476|3228947|Superiority or Other|||||||0.1026||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.|
1758177|NCT00207740|3229524|Superiority or Other|||||||0.82|||||||Wilcoxon (Mann-Whitney)||||
1758098|NCT00216476|3228947|Superiority or Other||||||<|0.0001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon signed-rank test|||Within-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the LOCF principle.|
1758099|NCT00216476|3228947|Superiority or Other||||||<|0.0001||||||The statistical test was interpreted at the 5% significance level.|Wilcoxon (Mann-Whitney)|||Between-group comparison of the change from baseline to endpoint in total PANSS score. The endpoint of the study was based on the Last Observation Carried Forward (LOCF) principle, i.e., it was defined as the last available visit during the study with non-missing data for a parameter (excluding the baseline value).|
1758100|NCT00216476|3228949|Superiority or Other||||||<|0.0001||||||threshold for significance: 0.05 (2-sided)|Log Rank|||Null hypothesis was that there is no difference in treatment effect between risperidone LAI and quetiapine by mean relapse free period; given a estimated relapse rate of 30% for risperidone LAI and 42% for quetiapine, with 80% power and 5% 2-tailed significance level, 251 subjects were needed per treatment arm. To adjust for an estimated 20% discontinuations for reasons other than relapse, 628 subjects in total were needed. Actual relapse rates were 17% (risperidone LAI) and 31% (quetiapine).|
1758101|NCT00216320|3228953|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1758102|NCT00216125|3228960|Superiority or Other||Median Difference (Final Values)|10.0||||0.883|2-Sided|95.0|||||Log Rank||||
1758103|NCT00216060|3228973|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis||||
1758104|NCT00216060|3228974|Superiority or Other|||||||0.01|||||||Kruskal-Wallis||||
1758105|NCT00216060|3228975|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis||||
1758106|NCT00216060|3228977|Superiority or Other||||||<|0.001|||||||Kruskal-Wallis||||
1758107|NCT00216060|3228979|Superiority or Other|||||||0.12|||||||univariate analysis||||
1758108|NCT00216060|3228980|Superiority or Other||Hazard Ratio (HR)|2.08||||0.3|2-Sided|95.0|0.51|8.4|||Regression, Cox||||
1758109|NCT00215553|3229001|Superiority or Other|||||||0.293|||||||ANOVA|ANOVA on ranks|||
1758110|NCT00215553|3229001|Superiority or Other|||||||0.147|||||||ANOVA|ANOVA on ranks|||
1758111|NCT00215553|3229001|Superiority or Other|||||||0.028|||||||ANOVA|ANOVA on ranks|||
1758112|NCT00215553|3229002|Superiority or Other|||||||0.964|||||||Cochran-Mantel-Haenszel||||
1758113|NCT00215553|3229002|Superiority or Other|||||||0.286|||||||Cochran-Mantel-Haenszel||||
1758114|NCT00215553|3229002|Superiority or Other|||||||0.346|||||||Cochran-Mantel-Haenszel||||
1758115|NCT00215553|3229003|Superiority or Other|||||||0.396|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups|
1758116|NCT00215553|3229003|Superiority or Other|||||||0.236|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups|
1758117|NCT00215553|3229003|Superiority or Other|||||||0.794|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference between treatment groups|
1758118|NCT00215540|3229004|Superiority or Other|||||||0.094|||||||ANOVA|On rank adjusting for pooled study center|||
1758119|NCT00215540|3229004|Superiority or Other|||||||0.516|||||||ANOVA|On rank adjusting for pooled study center|||
1758120|NCT00215540|3229004|Superiority or Other|||||||0.311|||||||ANOVA|On rank adjusting for pooled study center|||
1758121|NCT00215540|3229005|Superiority or Other|||||||0.313|||||||Cochran-Mantel-Haenszel|Adjusting for pooled study center|||
1758122|NCT00215540|3229005|Superiority or Other|||||||0.267|||||||Cochran-Mantel-Haenszel|Adjusting for pooled study center|||
1758123|NCT00215540|3229006|Superiority or Other|||||||0.275|||||||ANOVA|Adjusting for pooled study center|||
1758124|NCT00215540|3229006|Superiority or Other|||||||0.449|||||||ANOVA|Adjusting for pooled study center|||
1758125|NCT00215540|3229006|Superiority or Other|||||||0.813|||||||ANOVA|Adjusting for pooled study center|||
1758126|NCT00215540|3229007|Superiority or Other|||||||0.537|||||||ANOVA|Adjusting for pooled study center|||
1758127|NCT00215540|3229007|Superiority or Other|||||||0.543|||||||ANOVA|Adjusting for pooled study center|||
1758128|NCT00215540|3229007|Superiority or Other|||||||0.843|||||||ANOVA|Adjusting for pooled study center|||
1758129|NCT00215540|3229008|Superiority or Other|||||||0.006|||||||ANOVA|On rank adjusting for pooled study center|||
1758130|NCT00215540|3229008|Superiority or Other|||||||0.123|||||||ANOVA|On rank adjusting for pooled study center|||
1758131|NCT00215540|3229008|Superiority or Other|||||||0.483|||||||ANOVA|On rank adjusting for pooled study center|||
1758132|NCT00215540|3229009|Superiority or Other|||||||0.03|||||||ANOVA|On rank adjusting for pooled study center|||
1758133|NCT00215540|3229009|Superiority or Other|||||||0.229|||||||ANOVA|On rank adjusting for pooled study center|||
1758134|NCT00215540|3229009|Superiority or Other|||||||0.285|||||||ANOVA|On rank adjusting for pooled study center|||
1758135|NCT00215540|3229010|Superiority or Other|||||||0.046|||||||Cochran-Mantel-Haenszel|Adjusting for pooled study center|||
1758136|NCT00215540|3229010|Superiority or Other|||||||0.208|||||||Cochran-Mantel-Haenszel|Adjusting for pooled study center|||
1758137|NCT00215540|3229010|Superiority or Other|||||||0.476|||||||Cochran-Mantel-Haenszel|Adjusting for pooled study center|||
1758138|NCT00215540|3229011|Superiority or Other|||||||0.944|||||||Cochran-Mantel-Haenszel|Adjusting for pooled study center|||
1758139|NCT00215540|3229011|Superiority or Other|||||||0.313|||||||Cochran-Mantel-Haenszel|Adjusting for pooled study center|||
1758140|NCT00215540|3229011|Superiority or Other|||||||0.267|||||||Cochran-Mantel-Haenszel|Adjusting for pooled study center|||
1758141|NCT00215540|3229012|Superiority or Other|||||||0.146|||||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups|
1758142|NCT00215540|3229012|Superiority or Other|||||||0.5|||||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups|
1758143|NCT00215540|3229013|Superiority or Other|||||||0.208|||||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups|
1758144|NCT00215540|3229013|Superiority or Other|||||||0.476|||||||Cochran-Mantel-Haenszel|Adjusting for pooled study center||Null hypothesis: No difference between treatment groups|
1758145|NCT00215150|3229014|Superiority or Other||||||>|0.05|||||||Kruskal-Wallis|||Results are from a Kruskal Wallis test on the ziprasidone/placebo groups from the randomization phase of the project.|
1758146|NCT00215150|3229014|Superiority or Other||||||<|0.001|||||||Wilcoxon Signed Rank Test|||Results are from a Wilcoxon signed rank test on the difference from endpoint to baseline for the intent to treat sample from the open label phase of the project.|
1758147|NCT00215137|3229015|Superiority or Other|||||||0.0417|||||||Wilcoxon Rank Sum Test|||A Wilcoxon Rank Sum Test was performed on the difference in the pre and post randomization YBOCS scores, using grouping to either escitalopram or placebo as a grouping variable.|
1758148|NCT00215137|3229015|Superiority or Other|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||A Wilcoxon Signed Rank test was performed on the difference between the open label endpoint and baseline YBOCS scores.|
1758149|NCT00214903|3229016|Non-Inferiority or Equivalence|Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.|Hazard Ratio (HR)|0.5|||||2-Sided|95.0|0.3|0.8|||||Hazard ratio was adjusted for age, BMI, hypertension, diabetes, family history of fatal ATE, region, and smoking.|Tested null hypotheses: the ATE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.|
1758150|NCT00214903|3229017|Non-Inferiority or Equivalence|Sample size calculations were based on a non-inferiority test to exclude a two-fold risk of cardiovascular events in users of DRSP/E2 compared to other oral continuous combined HRT. These calculations are based on the following assumptions: 1) one-sided α 0.05; 2) power (1-β) of 0.80; 3) Estimated incidence of cardiovascular events, ATE and VTE would be at least 1.0, 0.3 and 0.2 event/100 woman-years and 4) non-inferiority limit hazard ratio of 2.|Hazard Ratio (HR)|0.8|||||2-Sided|95.0|0.5|1.3|||||Hazard ratio was adjusted for age, BMI, duration of current use, family history of VTE, region, and HRT user status.|Tested null hypotheses: the VTE hazard ratio for DRSP/E2 vs. ooccHRT is higher or equal to 2.|
1758151|NCT00214045|3229080|Non-Inferiority or Equivalence|Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.||||||0.37|||||||Wilcoxon (Mann-Whitney)||||
1758152|NCT00214045|3229080|Superiority or Other|Results were analyzed using Wilcoxon rank sums and Fisher exact tests with Statistical Analysis System (SAS) statistical software version 9.||||||0.39|||||||Wilcoxon (Mann-Whitney)||||
1758153|NCT00213135|3229093|Superiority or Other||Relative Risk|0.43|Standard Error of the Mean|0.12|<|0.001|2-Sided|95.0|0.34|0.54|||Wald Chi-square test||||
1758154|NCT00213135|3229093|Superiority or Other||Relative Risk|0.43|Standard Error of the Mean|0.11|<|0.001|2-Sided|95.0|0.35|0.54|||Wald Chi-square test||||
1758155|NCT00212264|3229110|Superiority or Other|||||||0.32|||||||t-test, 1 sided|Note that the no-treatment control group completed the study after 2 months and was not included in this analysis of treatment effect durability.|||
1758156|NCT00212264|3229111|Superiority or Other|||||||0.001|||||||ANOVA||||
1758157|NCT00212134|3229112|Superiority||Mean Difference (Final Values)|7.295|||>|0.05|2-Sided||||||t-test, 2 sided|||ITT comparison of mean PSI scores|
1758158|NCT00212134|3229114|Superiority||Mean Difference (Final Values)|15.7|||<|0.05|2-Sided||||||t-test, 2 sided|||ITT analyses comparing parents of children randomized to receive an IOL to those left aphakic.|
1758159|NCT00212134|3229115|Superiority|||||||0.008|||||||Fisher Exact||||
1758160|NCT00212134|3229116|Superiority|||||||0.03|||||||Fisher Exact||||
1758161|NCT00212134|3229118|Superiority|||||||0.54|||||||Wilcoxon (Mann-Whitney)||||
1758162|NCT00212134|3229119|Superiority|||||||0.19|||||||Wilcoxon (Mann-Whitney)||||
1758163|NCT00211536|3229140|Non-Inferiority or Equivalence|For the average A1C, the goal was to show non-inferiority of MIP compared to SC. The minimal clinically relevant increase in A1C (%) was set at 0.50%. The between-subjects standard deviation of A1C was assumed to be 1.0% based on previous studies.|Least square means|0.3|Standard Error of the Mean|0.2|<|0.05|1-Sided|95.0||0.5|||Mixed Models Analysis|Repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed to compare A1C trends over time between the treatment groups||Sample size calculations were performed on the primary endpoint: the average glycosylated hemoglobin (A1C). Sample size was estimated using a two-sample, one-sided t-test with a significance level of 0.05. The projected sample size of 50 subjects per treatment group provides 79% power to reject the null hypothesis in favor of the alternative hypothesis that the average A1C in both the MIP and SC groups are equivalent, assuming an effect size of 0.50% and a standard deviation of 1.0%.|
1758164|NCT00210626|3229199|Superiority or Other|||||||0.7038|||||||Chi-squared||||
1758165|NCT00210626|3229200|Superiority or Other|||||||0.3807|||||||ANCOVA|Covariate used is Baseline SF-36 PF Score. Baseline SF-36 PF Score was collected prior to the start of Procrit or Placebo treatment||The null hypothesis is that there is no difference between Procrit and Placebo in average SF-36 Physical Function Scores|
1758166|NCT00209131|3229455|Non-Inferiority or Equivalence||||||<|0.05|||||||Other|||No analysis was conducted.|
1758167|NCT00208507|3229464|Non-Inferiority or Equivalence|This was a non-inferiority test of the Harris Hip Score means at 24+ months with a 5 point non-inferiority margin.|Mean Difference (Final Values)|0.61||||0.001|1-Sided|95.0|-1.56||||ANCOVA|Preoperative Harris Hip score was included in the ANCOVA model as the only covariate.|||
1758168|NCT00208091|3229518|Superiority or Other||||||=|0|||||||Wilcoxon (Mann-Whitney)||||
1758169|NCT00208091|3229519|Superiority or Other||||||=|0|||||||Wilcoxon (Mann-Whitney)||||
1758170|NCT00207883|3229522|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1758171|NCT00207740|3229523|Superiority or Other|||||||0.726|||||||ANOVA||||
1758172|NCT00207740|3229523|Superiority or Other|||||||0.897|||||||ANOVA||||
1758173|NCT00207740|3229523|Superiority or Other|||||||0.814|||||||ANOVA||||
1758174|NCT00207740|3229523|Superiority or Other|||||||0.833|||||||ANOVA|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.|
1758175|NCT00207740|3229524|Superiority or Other|||||||0.021|||||||Wilcoxon (Mann-Whitney)||||
1758176|NCT00207740|3229524|Superiority or Other|||||||0.858|||||||Wilcoxon (Mann-Whitney)||||
1758178|NCT00207740|3229524|Superiority or Other|||||||0.986|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.|
1758179|NCT00207740|3229525|Superiority or Other|||||||0.341|||||||Cochran-Mantel-Haenszel||||
1758180|NCT00207740|3229525|Superiority or Other|||||||0.35|||||||Cochran-Mantel-Haenszel||||
1758181|NCT00207740|3229525|Superiority or Other|||||||0.382|||||||Cochran-Mantel-Haenszel||||
1758182|NCT00207740|3229525|Superiority or Other|||||||0.273|||||||Cochran-Mantel-Haenszel|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.|
1758183|NCT00207740|3229526|Superiority or Other|||||||0.856|||||||Kruskal-Wallis||||
1758184|NCT00207740|3229526|Superiority or Other|||||||0.731|||||||Kruskal-Wallis||||
1758185|NCT00207740|3229526|Superiority or Other|||||||0.572|||||||Kruskal-Wallis||||
1758186|NCT00207740|3229526|Superiority or Other|||||||0.894|||||||Kruskal-Wallis|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.|
1758187|NCT00207740|3229527|Superiority or Other|||||||0.256||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.|
1758188|NCT00207740|3229527|Superiority or Other|||||||0.649||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.|
1758189|NCT00207740|3229527|Superiority or Other|||||||0.779||||||The nominal p-value is for descriptive purpose only.|Cochran-Mantel-Haenszel|||This is a secondary analysis.|
1758190|NCT00207740|3229527|Superiority or Other|||||||0.718||||||When interpreting this p-value along with the other co-primary endpoint, Hochberg procedure was used.|Cochran-Mantel-Haenszel|||The null hypothesis was that the number of severe exacerbations per patient from baseline through week 24 for placebo is the same as that in the combined 100 mg and 200 mg golimumab. Assuming 1 severe exacerbation over 6 months per patient in the placebo group, there is 79% power to detect a 35% reduction in the combined 100 mg and 200 mg golimumab group at a 0.05 significance level.|
1758191|NCT00207740|3229528|Superiority or Other|||||||0.946|||||||Wilcoxon (Mann-Whitney)||||
1758192|NCT00207740|3229528|Superiority or Other|||||||0.128|||||||Wilcoxon (Mann-Whitney)||||
1758193|NCT00207740|3229528|Superiority or Other|||||||0.742|||||||Wilcoxon (Mann-Whitney)||||
1758194|NCT00207740|3229528|Superiority or Other|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the endpoint for placebo is the same as that in the combined 100 mg and 200 mg golimumab.|
1758195|NCT00207740|3229529|Superiority or Other|||||||0.357||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.|
1758196|NCT00207740|3229529|Superiority or Other|||||||0.717||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.|
1758197|NCT00207740|3229529|Superiority or Other|||||||0.945||||||The nominal p-value is for descriptive purpose only.|ANCOVA|||This is a secondary analysis.|
1758198|NCT00207740|3229529|Superiority or Other|||||||0.802||||||When interpreting this p-value along with the other co-primary endpoint, Hochberg procedure was used.|ANCOVA|||The null hypothesis was that the endpoint for placebo is the same as that for combined 100 mg and 200 mg golimumab. Assuming a standard deviation of 23%, there is 86% power to detect a 10% difference at a 0.05 significance level.|
1758199|NCT00207727|3229530|Superiority or Other|||||||0.292|||||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo||Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group with placebo..|
1758200|NCT00207727|3229530|Superiority or Other|||||||0.431|||||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo|||
1758201|NCT00207727|3229530|Superiority or Other|||||||0.152|||||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo|||
1758202|NCT00207727|3229530|Superiority or Other|||||||0.72|||||||Wilcoxon (Mann-Whitney)|2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo|||
1758203|NCT00207727|3229531|Superiority or Other|||||||0.967|||||||2-sided Wilcoxon Mann-Whitney|||Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group.|
1758204|NCT00207727|3229531|Superiority or Other|||||||0.517|||||||2-sided Wilcoxon Mann-Whitney||||
1758205|NCT00207727|3229531|Superiority or Other|||||||0.599|||||||2-sided Wilcoxon Mann-Whitney||||
1758206|NCT00207727|3229531|Superiority or Other|||||||0.892|||||||2-sided Wilcoxon Mann-Whitney||||
1758207|NCT00207727|3229532|Superiority or Other|||||||0||||||The p-value was non estimable because the observed trend was in the opposite direction of that stated in the one sided alternative hypothesis|Jonckheere Terpstra|Jonckheere Terpstra nonparametric trend test procedure with 5% level of significance was be used to test for the monotonic trend.||Hypothesis: The null hypothesis of no effect among the treatment groups was tested against the alternative hypothesis that the cumulative number of newly Gd-enhancing T1-weighted lesions on cranial MRIs through Week 23 would decrease monotonically with dose at a significance level of 0.05.|
1758208|NCT00207714|3229533|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golimumab 100 mg every 2 or 4 Weeks|
1758209|NCT00207714|3229533|Superiority or Other||||||<|0.01|||||||ANOVA on van der Waerden normal scores.|ANOVA on van der Waerden normal scores||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golibumab 100 mg every 4 weeks|
1758210|NCT00207714|3229533|Superiority or Other||||||<|0.095|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 2 or 4 Weeks|
1758211|NCT00207714|3229533|Superiority or Other||||||<|0.006|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 4 weeks|
1758319|NCT00205777|3229624|Superiority or Other|||||||0.54|||||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.|
1758212|NCT00207714|3229533|Superiority or Other||||||<|0.001|||||||ANOVA on van der Waerden normal scores.|||No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and combined golimumab groups.|
1758213|NCT00207714|3229534|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.|
1758214|NCT00207714|3229534|Superiority or Other||||||<|0.119|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.|
1758215|NCT00207714|3229534|Superiority or Other||||||<|0.281|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 50 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.|
1758216|NCT00207714|3229534|Superiority or Other||||||<|0.056|||||||Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Wk 16 between golimumab 50 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo.|
1758217|NCT00207714|3229534|Superiority or Other||||||<|0.01||||||A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level.|Cochran-Mantel-Haenszel|||Null hypothesis: No difference in ACR 20 response at Week 16 between combined golimumab groups and Placebo +MTX group. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25 % response in Placebo +MTX.|
1758218|NCT00207142|3229547|Superiority or Other||Difference in means at Week 48|7.0||||||95.0|-38.0|53.0|||||||
1758219|NCT00207142|3229548|Superiority or Other||Cox Proportional Hazard|0.84||||||95.0|0.37|1.9||||||Covariate in the model: treatment regimen|
1758220|NCT00207142|3229549|Superiority or Other||Cox Proportional Hazard|0.97||||||95.0|0.5|1.88||||||Covariate in the model: treatment regimen.|
1758221|NCT00207142|3229550|Superiority or Other||Difference in Proportions|5.0||||||95.0|-6.0|16.1|||||||
1758222|NCT00207142|3229551|Non-Inferiority or Equivalence|Efficacy at Week 48 on the Switch Arm was considered to be non-inferior to the Continuation Arm if the lower limit of the 95% Confidence Interval was greater than -15%.|Difference in proportions|2.9||||||95.0|-9.8|15.5||||||The planned sample size of 178 randomized subjects (89 on each regimen) provides at least 80% power to demonstrate that the response rate on ATV is within a 15% margin of the response rate on ATV/RTV assuming: a 2-sided 95% confidence interval for the difference in response rate between treatment regimens (switch-continuation); a response rate of 85% in both the Continuation and Switch regimens; a margin of -15% for the difference in response rates between treatment regimens.|
1758223|NCT00207090|3229568|Superiority or Other||Point estimate|0.566|||||2-Sided|90.0|0.482|0.664||||||Two-way analyses of variance were performed on log-transformed values of (AUC [INF]). The factors in the analyses were participant and day. Point estimates and 90% confidence intervals for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale.|
1758224|NCT00207090|3229569|Superiority or Other||Point estimate|0.912|||||2-Sided|90.0|0.751|1.106||||||Two-way analyses of variance were performed on log-transformed values of Cmax. The factors in the analyses were participant and day. Point estimates and 90% confidence intervals for means and differences between means on the log scale were exponentiated to obtain estimates for geometric means and ratio of geometric means on the original scale.|
1758225|NCT00206726|3229575|Superiority or Other||CR rate|0.0833||||0.014||90.0|0.0334|0.1673||2-sided p-value computed from an exact binomial test comparing the observed rate versus 2% historical rate|exact binomial test|||Comparison of CR rate versus 2 percent (%) historic control (p-value and 90% confidence interval)|
1758226|NCT00206323|3229583|Superiority or Other (legacy)|||||||0.0259|||||||t-test, 2 sided|||"Primary variable change of TTS/YGTSS at the BSL to Day 70. Changes of YGTSS compared using analysis of covariance with score at day 1 as a covariate. Groups compared for incidence of AE's and of AESI based on Fisher’s Exact Test. All tests were two-sided at the 5% level of significance.~The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment)"|
1758227|NCT00205803|3229608|Superiority or Other||Ratio|1.04|||||2-Sided|95.0|0.76|1.44||||||Pertussis - Pertactin|
1758228|NCT00205803|3229608|Superiority or Other||Ratio|1.02|||||2-Sided|95.0|0.83|1.25||||||Pertussis - PT|
1758229|NCT00205803|3229608|Superiority or Other||Ratio|0.92|||||2-Sided|95.0|0.74|1.15||||||Pertussis - FHA|
1758230|NCT00205803|3229609|Superiority or Other||Ratio|1.12|||||2-Sided|95.0|0.69|1.84||||||Polio Type 3|
1758231|NCT00205803|3229609|Superiority or Other||Ratio|0.91|||||2-Sided|95.0|0.56|1.49||||||Polio Type 2|
1758232|NCT00205803|3229609|Superiority or Other||Ratio|1.01|||||2-Sided|95.0|0.66|1.53||||||Polio Type 1|
1758233|NCT00205803|3229610|Superiority or Other||Ratio|0.83|||||2-Sided|95.0|0.57|1.21|||||||
1758234|NCT00205803|3229611|Superiority or Other||Ratio|0.97|||||2-Sided|95.0|0.63|1.48|||||||
1758235|NCT00205803|3229612|Superiority or Other||Ratio|1.21|||||2-Sided|95.0|0.69|2.14|||||||
1758236|NCT00205803|3229613|Superiority or Other||Difference|1.33||||||95.0|-6.79|9.68||||||For Pertussis - Pertactin the difference in percentage between the two groups (13vPnC - 7vPnC) at 18.00 EU/mL threshold was calculated|
1758237|NCT00205803|3229613|Superiority or Other||Difference|-6.36||||||95.0|-17.03|3.16||||||For Pertussis - PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 43.00 EU/mL threshold was calculated|
1758238|NCT00205803|3229613|Superiority or Other||Difference|-1.74||||||95.0|-11.0|6.99||||||For Pertussis - FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 82.00 EU/MI threshold was calculated|
1758239|NCT00205803|3229613|Superiority or Other||Difference|0.0||||||95.0|-9.38|7.73||||||For Hepatitis b the difference in percentage between the two groups (13vPnC - 7vPnC) at 10 mIU/mL threshold was calculated|
1758240|NCT00205803|3229613|Superiority or Other||Difference|-1.64||||||95.0|-8.8|4.21||||||For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated|
1758241|NCT00205803|3229613|Superiority or Other||Difference|-1.64||||||95.0|-8.8|4.24||||||For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated|
1758242|NCT00205803|3229613|Superiority or Other||Difference|0.0||||||95.0|-5.97|5.68||||||For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 threshold was calculated|
1758243|NCT00205803|3229613|Superiority or Other||Difference|0.0||||||95.0|-9.38|7.73||||||For Tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated|
1758244|NCT00205803|3229613|Superiority or Other||Difference|0.0||||||95.0|-9.38|7.73||||||For Diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL and 0.1 IU/mL thresholds was calculated|
1758245|NCT00205803|3229613|Superiority or Other||Difference|7.02||||||95.0|-7.28|21.14||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated|
1758246|NCT00205803|3229613|Superiority or Other||Difference|3.08||||||95.0|-7.22|13.73||||||For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated|
1758247|NCT00205803|3229615|Superiority or Other||Ratio|1.71||||||95.0|1.36|2.16||||||For serotype 19A the GMC ratio (13vPnC/7vPnC) was calculated|
1758248|NCT00205803|3229615|Superiority or Other||Ratio|26.78||||||95.0|20.97|34.22||||||For serotype 7F the GMC ratio (13vPnC/7vPnC) was calculated|
1758249|NCT00205803|3229615|Superiority or Other||Ratio|9.6||||||95.0|7.07|13.04||||||For serotype 6A the GMC ratio (13vPnC/7vPnC) was calculated|
1758250|NCT00205803|3229615|Superiority or Other||Ratio|8.67||||||95.0|6.65|11.29||||||For serotype 5 the GMC ratio (13vPnC/7vPnC) was calculated|
1758251|NCT00205803|3229615|Superiority or Other||Ratio|15.56||||||95.0|11.63|20.81||||||For serotype 3 the GMC ratio (13vPnC/7vPnC) was calculated|
1758252|NCT00205803|3229615|Superiority or Other||Ratio|39.78||||||95.0|27.47|57.63||||||For serotype 1 the GMC ratio (13vPnC/7vPnC) was calculated|
1758253|NCT00205803|3229615|Superiority or Other||Ratio|0.77||||||95.0|0.59|1.0||||||For serotype 23F the GMC ratio (13vPnC/7vPnC) was calculated|
1758254|NCT00205803|3229615|Superiority or Other||Ratio|0.86||||||95.0|0.67|1.09||||||For serotype 19F the GMC ratio (13vPnC/7vPnC) was calculated|
1758255|NCT00205803|3229615|Superiority or Other||Ratio|0.62||||||95.0|0.49|0.79||||||For serotype 18C the GMC ratio (13vPnC/7vPnC) was calculated|
1758256|NCT00205803|3229615|Superiority or Other||Ratio|0.82||||||95.0|0.6|1.11||||||For serotype 14 the GMC ratio (13vPnC/7vPnC) was calculated|
1758257|NCT00205803|3229615|Superiority or Other||Difference|0.85||||||95.0|0.69|1.05||||||For serotype 9V the GMC ratio (13vPnC/7vPnC) was calculated|
1758258|NCT00205803|3229615|Superiority or Other||Ratio|0.96||||||95.0|0.62|1.48||||||For serotype 6B the GMC ratio (13vPnC/7vPnC) was calculated|
1758259|NCT00205803|3229615|Superiority or Other||Ratio|0.76||||||95.0|0.59|0.96||||||For serotype 4 the GMC ratio (13vPnC/7vPnC) was calculated|
1758260|NCT00205803|3229616|Superiority or Other||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758261|NCT00205803|3229616|Superiority or Other||Difference|94.1||||||95.0|86.8|98.1||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758262|NCT00205803|3229616|Superiority or Other||Difference|12.0||||||95.0|5.9|20.4||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758263|NCT00205803|3229616|Superiority or Other||Difference|29.5||||||95.0|19.7|40.9||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758264|NCT00205803|3229616|Superiority or Other||Difference|83.6||||||95.0|73.2|90.8||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758265|NCT00205803|3229616|Superiority or Other||Difference|97.8||||||95.0|92.3|99.7||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758266|NCT00205803|3229616|Superiority or Other||Difference|2.2||||||95.0|-2.6|7.7||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758267|NCT00205803|3229616|Superiority or Other||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758268|NCT00205803|3229616|Superiority or Other||Difference|0.0||||||95.0|-4.7|3.9||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758269|NCT00205803|3229616|Superiority or Other||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758270|NCT00205803|3229616|Superiority or Other||Difference|-1.3||||||95.0|-6.9|2.8||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758271|NCT00205803|3229616|Superiority or Other||Difference|0.0||||||95.0|-4.6|4.0||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758272|NCT00205803|3229616|Superiority or Other||Difference|-1.5||||||95.0|-7.9|3.6||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758273|NCT00205803|3229617|Superiority or Other||Difference|5.61||||||95.0|1.23|11.86||||||For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758274|NCT00205803|3229617|Superiority or Other||Difference|92.27||||||95.0|85.26|96.54||||||For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758275|NCT00205803|3229617|Superiority or Other||Difference|62.81||||||95.0|52.33|72.2||||||For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758383|NCT00205777|3229639|Superiority or Other|||||||0.17|||||||ANOVA||||
1758276|NCT00205803|3229617|Superiority or Other||Difference|57.94||||||95.0|48.01|67.42||||||For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758277|NCT00205803|3229617|Superiority or Other||Difference|84.92||||||95.0|76.73|91.05||||||For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758278|NCT00205803|3229617|Superiority or Other||Difference|72.87||||||95.0|63.32|81.07||||||For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758279|NCT00205803|3229617|Superiority or Other||Difference|-0.69||||||95.0|-7.75|5.86||||||For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758280|NCT00205803|3229617|Superiority or Other||Difference|0.7||||||95.0|-4.84|6.32||||||For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758281|NCT00205803|3229617|Superiority or Other||Difference|-2.25||||||95.0|-8.18|2.36||||||For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758282|NCT00205803|3229617|Superiority or Other||Difference|0.68||||||95.0|-4.96|6.16||||||For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758283|NCT00205803|3229617|Superiority or Other||Difference|-2.27|||||2-Sided|95.0|-8.07|2.26||||||For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758284|NCT00205803|3229617|Superiority or Other||Difference|-0.49|||||2-Sided|95.0|-9.93|8.65||||||For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758285|NCT00205803|3229617|Superiority or Other||Difference|-2.26|||||2-Sided|95.0|-8.08|2.33||||||For serotype 4 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated|
1758286|NCT00205777|3229620|Superiority or Other|||||||0.83|||||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.|
1758287|NCT00205777|3229620|Superiority or Other|||||||0.89|||||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.|
1758288|NCT00205777|3229620|Superiority or Other|||||||0.92|||||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.|
1758289|NCT00205777|3229620|Superiority or Other|||||||0.76|||||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.|
1758290|NCT00205777|3229620|Superiority or Other|||||||0.96|||||||ANOVA|||Change at Month 36 in EQ-5D: P value was calculated using ANOVA.|
1758291|NCT00205777|3229620|Superiority or Other|||||||0.88|||||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.|
1758292|NCT00205777|3229620|Superiority or Other|||||||0.22|||||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.|
1758293|NCT00205777|3229620|Superiority or Other|||||||0.14|||||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.|
1758294|NCT00205777|3229620|Superiority or Other|||||||0.11|||||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.|
1758295|NCT00205777|3229620|Superiority or Other|||||||0.82|||||||ANOVA|||Change at Month 24 in EQ-5D: P value was calculated using ANOVA.|
1758296|NCT00205777|3229620|Superiority or Other|||||||0.86|||||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.|
1758297|NCT00205777|3229620|Superiority or Other|||||||0.88|||||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.|
1758298|NCT00205777|3229620|Superiority or Other|||||||0.84|||||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.|
1758299|NCT00205777|3229620|Superiority or Other|||||||0.98|||||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.|
1758300|NCT00205777|3229620|Superiority or Other|||||||0.72|||||||ANOVA|||Change at Month 12 in EQ-5D: P value was calculated using ANOVA.|
1758301|NCT00205777|3229622|Superiority or Other|||||||0.3|||||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.|
1758302|NCT00205777|3229622|Superiority or Other|||||||0.059|||||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.|
1758303|NCT00205777|3229622|Superiority or Other|||||||0.16|||||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.|
1758304|NCT00205777|3229622|Superiority or Other|||||||0.72|||||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.|
1758305|NCT00205777|3229622|Superiority or Other|||||||0.62|||||||ANOVA|||Change at Month 36 in EQ-5D VAS: P value was calculated using ANOVA.|
1758306|NCT00205777|3229622|Superiority or Other|||||||0.78|||||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.|
1758307|NCT00205777|3229622|Superiority or Other|||||||0.24|||||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.|
1758308|NCT00205777|3229622|Superiority or Other|||||||0.78|||||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.|
1758309|NCT00205777|3229622|Superiority or Other|||||||0.57|||||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.|
1758310|NCT00205777|3229622|Superiority or Other|||||||0.14|||||||ANOVA|||Change at Month 24 in EQ-5D VAS: P value was calculated using ANOVA.|
1758311|NCT00205777|3229622|Superiority or Other|||||||0.51|||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.|
1758312|NCT00205777|3229622|Superiority or Other|||||||0.34|||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.|
1758313|NCT00205777|3229622|Superiority or Other|||||||0.76|||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.|
1758314|NCT00205777|3229622|Superiority or Other|||||||0.058|||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.|
1758315|NCT00205777|3229622|Superiority or Other|||||||0.21|||||||ANOVA|||Change at Month 12 in EQ-5D VAS: P value was calculated using ANOVA.|
1758316|NCT00205777|3229624|Superiority or Other|||||||0.34|||||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.|
1758317|NCT00205777|3229624|Superiority or Other|||||||0.35|||||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.|
1758318|NCT00205777|3229624|Superiority or Other|||||||0.11|||||||ANOVA|||Change at Month 36 in QUALEFFO: P value was calculated using ANOVA.|
1758321|NCT00205777|3229624|Superiority or Other|||||||0.45|||||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.|
1758322|NCT00205777|3229624|Superiority or Other|||||||0.4|||||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.|
1758323|NCT00205777|3229624|Superiority or Other|||||||0.053|||||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.|
1758324|NCT00205777|3229624|Superiority or Other|||||||0.25|||||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.|
1758325|NCT00205777|3229624|Superiority or Other|||||||0.27|||||||ANOVA|||Change at Month 24 in QUALEFFO: P value was calculated using ANOVA.|
1758326|NCT00205777|3229624|Superiority or Other|||||||0.36|||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.|
1758327|NCT00205777|3229624|Superiority or Other|||||||0.18|||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.|
1758328|NCT00205777|3229624|Superiority or Other|||||||0.65|||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.|
1758329|NCT00205777|3229624|Superiority or Other|||||||0.41|||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.|
1758330|NCT00205777|3229624|Superiority or Other|||||||0.08|||||||ANOVA|||Change at Month 12 in QUALEFFO: P value was calculated using ANOVA.|
1758331|NCT00205777|3229626|Superiority or Other|||||||0.35|||||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.|
1758332|NCT00205777|3229626|Superiority or Other|||||||0.35|||||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.|
1758333|NCT00205777|3229626|Superiority or Other|||||||0.98|||||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.|
1758334|NCT00205777|3229626|Superiority or Other|||||||0.34|||||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.|
1758335|NCT00205777|3229626|Superiority or Other|||||||0.36|||||||ANOVA|||Change at Month 36 in WHQ: P value was calculated using ANOVA.|
1758336|NCT00205777|3229626|Superiority or Other|||||||0.93|||||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.|
1758337|NCT00205777|3229626|Superiority or Other|||||||0.76|||||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.|
1758338|NCT00205777|3229626|Superiority or Other|||||||0.096|||||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.|
1758339|NCT00205777|3229626|Superiority or Other|||||||0.12|||||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.|
1758340|NCT00205777|3229626|Superiority or Other|||||||0.18|||||||ANOVA|||Change at Month 24 in WHQ: P value was calculated using ANOVA.|
1758341|NCT00205777|3229626|Superiority or Other|||||||0.86|||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.|
1758342|NCT00205777|3229626|Superiority or Other|||||||0.92|||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.|
1758343|NCT00205777|3229626|Superiority or Other|||||||0.17|||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.|
1758344|NCT00205777|3229626|Superiority or Other|||||||0.12|||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.|
1758345|NCT00205777|3229626|Superiority or Other|||||||0.2|||||||ANOVA|||Change at Month 12 in WHQ: P value was calculated using ANOVA.|
1758346|NCT00205777|3229628|Superiority or Other|||||||0.056|||||||ANOVA||||
1758347|NCT00205777|3229628|Superiority or Other|||||||0.15|||||||ANOVA||||
1758348|NCT00205777|3229629|Superiority or Other|||||||0.14|||||||ANOVA||||
1758349|NCT00205777|3229629|Superiority or Other|||||||0.061|||||||ANOVA||||
1758350|NCT00205777|3229629|Superiority or Other|||||||0.05|||||||ANOVA||||
1758351|NCT00205777|3229629|Superiority or Other|||||||0.61|||||||ANOVA||||
1758352|NCT00205777|3229629|Superiority or Other|||||||0.97|||||||ANOVA||||
1758353|NCT00205777|3229630|Superiority or Other|||||||0.18|||||||ANOVA||||
1758354|NCT00205777|3229630|Superiority or Other|||||||0.41|||||||ANOVA||||
1758355|NCT00205777|3229631|Superiority or Other|||||||0.17|||||||ANOVA||||
1758356|NCT00205777|3229631|Superiority or Other|||||||0.89|||||||ANOVA||||
1758357|NCT00205777|3229631|Superiority or Other|||||||0.26|||||||ANOVA||||
1758358|NCT00205777|3229631|Superiority or Other|||||||0.76|||||||ANOVA||||
1758359|NCT00205777|3229631|Superiority or Other|||||||0.22|||||||ANOVA||||
1758360|NCT00205777|3229632|Superiority or Other|||||||0.61|||||||ANOVA||||
1758361|NCT00205777|3229632|Superiority or Other|||||||0.7|||||||ANOVA||||
1758362|NCT00205777|3229633|Superiority or Other|||||||0.12|||||||ANOVA||||
1758363|NCT00205777|3229633|Superiority or Other|||||||0.041|||||||ANOVA||||
1758364|NCT00205777|3229633|Superiority or Other|||||||0.28|||||||ANOVA||||
1758365|NCT00205777|3229633|Superiority or Other|||||||0.62|||||||ANOVA||||
1758366|NCT00205777|3229633|Superiority or Other|||||||0.3|||||||ANOVA||||
1758367|NCT00205777|3229634|Superiority or Other|||||||0.61|||||||ANOVA||||
1758368|NCT00205777|3229634|Superiority or Other|||||||0.79|||||||ANOVA||||
1758369|NCT00205777|3229635|Superiority or Other|||||||0.012|||||||ANOVA||||
1758370|NCT00205777|3229635|Superiority or Other|||||||0.023|||||||ANOVA||||
1758371|NCT00205777|3229635|Superiority or Other|||||||0.009|||||||ANOVA||||
1758372|NCT00205777|3229635|Superiority or Other|||||||0.91|||||||ANOVA||||
1758373|NCT00205777|3229635|Superiority or Other|||||||0.77|||||||ANOVA||||
1758374|NCT00205777|3229636|Superiority or Other|||||||0.07|||||||ANOVA||||
1758375|NCT00205777|3229636|Superiority or Other|||||||0.25|||||||ANOVA||||
1758376|NCT00205777|3229637|Superiority or Other|||||||0.24|||||||ANOVA||||
1758377|NCT00205777|3229637|Superiority or Other|||||||0.11|||||||ANOVA||||
1758378|NCT00205777|3229637|Superiority or Other|||||||0.13|||||||ANOVA||||
1758379|NCT00205777|3229637|Superiority or Other|||||||0.74|||||||ANOVA||||
1758380|NCT00205777|3229637|Superiority or Other|||||||0.9|||||||ANOVA||||
1758395|NCT00205777|3229642|Superiority or Other|||||||0.52|||||||ANOVA|||RmP: P value was calculated using ANOVA.|
1758396|NCT00205777|3229642|Superiority or Other|||||||0.6|||||||ANOVA|||RmP: P value was calculated using ANOVA.|
1758397|NCT00205777|3229642|Superiority or Other|||||||0.43|||||||ANOVA|||RP: P value was calculated using ANOVA.|
1758398|NCT00205777|3229642|Superiority or Other|||||||1|||||||ANOVA|||RP: P value was calculated using ANOVA.|
1758399|NCT00205777|3229642|Superiority or Other|||||||0.53|||||||ANOVA|||BFP: P value was calculated using ANOVA.|
1758400|NCT00205777|3229642|Superiority or Other|||||||0.6|||||||ANOVA|||BFP: P value was calculated using ANOVA.|
1758401|NCT00205777|3229643|Superiority or Other|||||||0.006|||||||ANOVA|||RmP: P value was calculated using ANOVA.|
1758402|NCT00205777|3229643|Superiority or Other|||||||0.015|||||||ANOVA|||RmP: P value was calculated using ANOVA.|
1758403|NCT00205777|3229643|Superiority or Other|||||||0.01|||||||ANOVA|||RmP: P value was calculated using ANOVA.|
1758404|NCT00205777|3229643|Superiority or Other|||||||0.85|||||||ANOVA|||RmP: P value was calculated using ANOVA.|
1758405|NCT00205777|3229643|Superiority or Other|||||||0.93|||||||ANOVA|||RmP: P value was calculated using ANOVA.|
1758406|NCT00205777|3229643|Superiority or Other|||||||0.14|||||||ANOVA|||RP: P value was calculated using ANOVA.|
1758407|NCT00205777|3229643|Superiority or Other|||||||0.28|||||||ANOVA|||RP: P value was calculated using ANOVA.|
1758408|NCT00205777|3229643|Superiority or Other|||||||0.47|||||||ANOVA|||RP: P value was calculated using ANOVA.|
1758409|NCT00205777|3229643|Superiority or Other|||||||0.44|||||||ANOVA|||RP: P value was calculated using ANOVA.|
1758410|NCT00205777|3229643|Superiority or Other|||||||0.7|||||||ANOVA|||RP: P value was calculated using ANOVA.|
1758411|NCT00205777|3229643|Superiority or Other|||||||0.006|||||||ANOVA|||BFP: P value was calculated using ANOVA.|
1758412|NCT00205777|3229643|Superiority or Other|||||||0.013|||||||ANOVA|||BFP: P value was calculated using ANOVA.|
1758413|NCT00205777|3229643|Superiority or Other|||||||0.005|||||||ANOVA|||BFP: P value was calculated using ANOVA.|
1758414|NCT00205777|3229643|Superiority or Other|||||||0.96|||||||ANOVA|||BFP: P value was calculated using ANOVA.|
1758415|NCT00205777|3229643|Superiority or Other|||||||0.81|||||||ANOVA|||BFP: P value was calculated using ANOVA.|
1758416|NCT00205777|3229644|Superiority or Other|||||||0.8|||||||ANOVA||||
1758417|NCT00205777|3229644|Superiority or Other|||||||0.73|||||||ANOVA||||
1758418|NCT00205777|3229645|Superiority or Other|||||||0.5|||||||ANOVA||||
1758419|NCT00205777|3229645|Superiority or Other|||||||0.92|||||||ANOVA||||
1758420|NCT00205777|3229645|Superiority or Other|||||||0.63|||||||ANOVA||||
1758421|NCT00205777|3229645|Superiority or Other|||||||0.83|||||||ANOVA||||
1758422|NCT00205777|3229645|Superiority or Other|||||||0.71|||||||ANOVA||||
1758423|NCT00205777|3229646|Superiority or Other|||||||0.4|||||||ANOVA||||
1758424|NCT00205777|3229646|Superiority or Other|||||||1|||||||ANOVA||||
1758425|NCT00205777|3229647|Superiority or Other|||||||0.15|||||||ANOVA||||
1758426|NCT00205777|3229647|Superiority or Other|||||||0.95|||||||ANOVA||||
1758427|NCT00205777|3229647|Superiority or Other|||||||0.3|||||||ANOVA||||
1758428|NCT00205777|3229647|Superiority or Other|||||||0.66|||||||ANOVA||||
1758429|NCT00205777|3229647|Superiority or Other|||||||0.35|||||||ANOVA||||
1758430|NCT00205777|3229648|Superiority or Other|||||||0.32|||||||ANOVA|||TbSp: P value was calculated using ANOVA.|
1758431|NCT00205777|3229648|Superiority or Other|||||||0.43|||||||ANOVA|||TbSp: P value was calculated using ANOVA.|
1758432|NCT00205777|3229648|Superiority or Other|||||||0.78|||||||ANOVA|||TbTh: P value was calculated using ANOVA.|
1758433|NCT00205777|3229648|Superiority or Other|||||||0.97|||||||ANOVA|||TbTh: P value was calculated using ANOVA.|
1758434|NCT00205777|3229648|Superiority or Other|||||||0.37|||||||ANOVA|||OTh: P value was calculated using ANOVA.|
1758435|NCT00205777|3229648|Superiority or Other|||||||0.049|||||||ANOVA|||OTh: P value was calculated using ANOVA.|
1758436|NCT00205777|3229648|Superiority or Other|||||||0.29|||||||ANOVA|||WTh: P value was calculated using ANOVA.|
1758437|NCT00205777|3229648|Superiority or Other|||||||0.018|||||||ANOVA|||WTh: P value was calculated using ANOVA.|
1758438|NCT00205777|3229649|Superiority or Other|||||||0.35|||||||ANOVA|||CTh: P value was calculated using ANOVA.|
1758439|NCT00205777|3229649|Superiority or Other|||||||0.25|||||||ANOVA|||CTh: P value was calculated using ANOVA.|
1758440|NCT00205777|3229649|Superiority or Other|||||||0.83|||||||ANOVA|||CTh: P value was calculated using ANOVA.|
1758441|NCT00205777|3229649|Superiority or Other|||||||0.46|||||||ANOVA|||CTh: P value was calculated using ANOVA.|
1758442|NCT00205777|3229649|Superiority or Other|||||||0.17|||||||ANOVA|||CTh: P value was calculated using ANOVA.|
1758443|NCT00205777|3229649|Superiority or Other|||||||0.057|||||||ANOVA|||TbSp: P value was calculated using ANOVA.|
1758444|NCT00205777|3229649|Superiority or Other|||||||0.79|||||||ANOVA|||TbSp: P value was calculated using ANOVA.|
1758445|NCT00205777|3229649|Superiority or Other|||||||0.1|||||||ANOVA|||TbSp: P value was calculated using ANOVA.|
1758446|NCT00205777|3229649|Superiority or Other|||||||0.75|||||||ANOVA|||TbSp: P value was calculated using ANOVA.|
1758447|NCT00205777|3229649|Superiority or Other|||||||0.18|||||||ANOVA|||TbSp: P value was calculated using ANOVA.|
1758448|NCT00205777|3229649|Superiority or Other|||||||0.46|||||||ANOVA|||TbTh: P value was calculated using ANOVA.|
1758449|NCT00205777|3229649|Superiority or Other|||||||0.9|||||||ANOVA|||TbTh: P value was calculated using ANOVA.|
1758450|NCT00205777|3229649|Superiority or Other|||||||0.41|||||||ANOVA|||TbTh: P value was calculated using ANOVA.|
1758451|NCT00205777|3229649|Superiority or Other|||||||0.12|||||||ANOVA|||TbTh: P value was calculated using ANOVA.|
1758452|NCT00205777|3229649|Superiority or Other|||||||0.35|||||||ANOVA|||TbTh: P value was calculated using ANOVA.|
1759156|NCT00191139|3230719|Superiority or Other||Response Rate|75.0||||||95.0|56.6|88.5|||||||
1758453|NCT00205777|3229649|Superiority or Other|||||||0.077|||||||ANOVA|||OTh: P value was calculated using ANOVA.|
1758454|NCT00205777|3229649|Superiority or Other|||||||0.042|||||||ANOVA|||OTh: P value was calculated using ANOVA.|
1758455|NCT00205777|3229649|Superiority or Other|||||||0.71|||||||ANOVA|||OTh: P value was calculated using ANOVA.|
1758456|NCT00205777|3229649|Superiority or Other|||||||0.15|||||||ANOVA|||OTh: P value was calculated using ANOVA.|
1758457|NCT00205777|3229649|Superiority or Other|||||||0.085|||||||ANOVA|||OTh: P value was calculated using ANOVA.|
1758458|NCT00205777|3229649|Superiority or Other|||||||0.41|||||||ANOVA|||WTh: p-value was calculated using ANOVA.|
1758459|NCT00205777|3229649|Superiority or Other|||||||0.73|||||||ANOVA|||WTh: p-value was calculated using ANOVA.|
1758460|NCT00205777|3229649|Superiority or Other|||||||0.37|||||||ANOVA|||WTh: p-value was calculated using ANOVA.|
1758461|NCT00205777|3229649|Superiority or Other|||||||0.087|||||||ANOVA|||WTh: p-value was calculated using ANOVA.|
1758462|NCT00205777|3229649|Superiority or Other|||||||0.22|||||||ANOVA|||WTh: P value was calculated using ANOVA.|
1758463|NCT00205777|3229650|Superiority or Other|||||||0.96|||||||ANOVA|||OMS: P value was calculated using ANOVA.|
1758464|NCT00205777|3229650|Superiority or Other|||||||0.62|||||||ANOVA|||OMS: P value was calculated using ANOVA.|
1758465|NCT00205777|3229650|Superiority or Other|||||||0.28|||||||ANOVA|||ES: P value was calculated using ANOVA.|
1758466|NCT00205777|3229650|Superiority or Other|||||||0.069|||||||ANOVA|||ES: P value was calculated using ANOVA.|
1758467|NCT00205777|3229650|Superiority or Other|||||||0.055|||||||ANOVA|||MS: P value was calculated using ANOVA.|
1758468|NCT00205777|3229650|Superiority or Other|||||||0.11|||||||ANOVA|||MS: P value was calculated using ANOVA.|
1758469|NCT00205777|3229650|Superiority or Other|||||||0.22|||||||ANOVA|||ObS: P value was calculated using ANOVA.|
1758470|NCT00205777|3229650|Superiority or Other|||||||0.14|||||||ANOVA|||ObS: P value was calculated using ANOVA.|
1758471|NCT00205777|3229650|Superiority or Other|||||||0.56|||||||ANOVA|||OcS: P value was calculated using ANOVA.|
1758472|NCT00205777|3229650|Superiority or Other|||||||0.18|||||||ANOVA|||OcS: P value was calculated using ANOVA.|
1758473|NCT00205777|3229650|Superiority or Other|||||||0.045|||||||ANOVA|||OS: P value was calculated using ANOVA.|
1758474|NCT00205777|3229650|Superiority or Other|||||||0.05|||||||ANOVA|||OS: P value was calculated using ANOVA.|
1758475|NCT00205777|3229650|Superiority or Other|||||||0.01|||||||ANOVA|||OV: P value was calculated using ANOVA.|
1758476|NCT00205777|3229650|Superiority or Other|||||||0.006|||||||ANOVA|||OV: P value was calculated using ANOVA.|
1758477|NCT00205777|3229650|Superiority or Other|||||||0.65|||||||ANOVA|||BV: P value was calculated using ANOVA.|
1758478|NCT00205777|3229650|Superiority or Other|||||||0.7|||||||ANOVA|||BV: P value was calculated using ANOVA.|
1758479|NCT00205777|3229651|Superiority or Other|||||||0.73|||||||ANOVA|||CP: P value was calculated using ANOVA.|
1758480|NCT00205777|3229651|Superiority or Other|||||||0.76|||||||ANOVA|||CP: P value was calculated using ANOVA.|
1758481|NCT00205777|3229651|Superiority or Other|||||||0.98|||||||ANOVA|||CP: P value was calculated using ANOVA.|
1758482|NCT00205777|3229651|Superiority or Other|||||||0.7|||||||ANOVA|||CP: P value was calculated using ANOVA.|
1758483|NCT00205777|3229651|Superiority or Other|||||||0.78|||||||ANOVA|||CP: P value was calculated using ANOVA.|
1758484|NCT00205777|3229651|Superiority or Other|||||||0.13|||||||ANOVA|||OMS: P value was calculated using ANOVA.|
1758485|NCT00205777|3229651|Superiority or Other|||||||0.12|||||||ANOVA|||OMS: P value was calculated using ANOVA.|
1758486|NCT00205777|3229651|Superiority or Other|||||||0.06|||||||ANOVA|||OMS: P value was calculated using ANOVA.|
1758487|NCT00205777|3229651|Superiority or Other|||||||0.75|||||||ANOVA|||OMS: P value was calculated using ANOVA.|
1758488|NCT00205777|3229651|Superiority or Other|||||||0.8|||||||ANOVA|||OMS: P value was calculated using ANOVA.|
1758489|NCT00205777|3229651|Superiority or Other|||||||0.89|||||||ANOVA|||ES: P value was calculated using ANOVA.|
1758490|NCT00205777|3229651|Superiority or Other|||||||0.3|||||||ANOVA|||ES: P value was calculated using ANOVA.|
1758491|NCT00205777|3229651|Superiority or Other|||||||0.024|||||||ANOVA|||ES: P value was calculated using ANOVA.|
1758492|NCT00205777|3229651|Superiority or Other|||||||0.035|||||||ANOVA|||ES: P value was calculated using ANOVA.|
1758493|NCT00205777|3229651|Superiority or Other|||||||0.24|||||||ANOVA|||ES: P value was calculated using ANOVA.|
1758494|NCT00205777|3229651|Superiority or Other|||||||0.08|||||||ANOVA|||MS: P value was calculated using ANOVA.|
1758495|NCT00205777|3229651|Superiority or Other|||||||0.085|||||||ANOVA|||MS: P value was calculated using ANOVA.|
1758496|NCT00205777|3229651|Superiority or Other|||||||0.12|||||||ANOVA|||MS: P value was calculated using ANOVA.|
1758497|NCT00205777|3229651|Superiority or Other|||||||0.82|||||||ANOVA|||MS: P value was calculated using ANOVA.|
1758498|NCT00205777|3229651|Superiority or Other|||||||0.82|||||||ANOVA|||MS: P value was calculated using ANOVA.|
1758499|NCT00205777|3229651|Superiority or Other|||||||0.087|||||||ANOVA|||ObS: P value was calculated using ANOVA.|
1758500|NCT00205777|3229651|Superiority or Other|||||||0.091|||||||ANOVA|||ObS: P value was calculated using ANOVA.|
1758501|NCT00205777|3229651|Superiority or Other|||||||0.27|||||||ANOVA|||ObS: P value was calculated using ANOVA.|
1758502|NCT00205777|3229651|Superiority or Other|||||||0.5|||||||ANOVA|||ObS: P value was calculated using ANOVA.|
1758503|NCT00205777|3229651|Superiority or Other|||||||0.51|||||||ANOVA|||ObS: P value was calculated using ANOVA.|
1758504|NCT00205777|3229651|Superiority or Other|||||||0.053|||||||ANOVA|||OcS: P value was calculated using ANOVA.|
1758505|NCT00205777|3229651|Superiority or Other|||||||0.33|||||||ANOVA|||OcS: P value was calculated using ANOVA.|
1758506|NCT00205777|3229651|Superiority or Other|||||||0.65|||||||ANOVA|||OcS: P value was calculated using ANOVA.|
1758507|NCT00205777|3229651|Superiority or Other|||||||0.13|||||||ANOVA|||OcS: P value was calculated using ANOVA.|
1758508|NCT00205777|3229651|Superiority or Other|||||||0.59|||||||ANOVA|||OcS: P value was calculated using ANOVA.|
1758509|NCT00205777|3229651|Superiority or Other|||||||0.47|||||||ANOVA|||OS: P value was calculated using ANOVA.|
1758510|NCT00205777|3229651|Superiority or Other|||||||0.98|||||||ANOVA|||OS: P value was calculated using ANOVA.|
1758511|NCT00205777|3229651|Superiority or Other|||||||0.84|||||||ANOVA|||OS: P value was calculated using ANOVA.|
1758512|NCT00205777|3229651|Superiority or Other|||||||0.6|||||||ANOVA|||OS: P value was calculated using ANOVA.|
1758513|NCT00205777|3229651|Superiority or Other|||||||0.86|||||||ANOVA|||OS: P value was calculated using ANOVA.|
1758514|NCT00205777|3229651|Superiority or Other|||||||0.28|||||||ANOVA|||OV: P value was calculated using ANOVA.|
1758515|NCT00205777|3229651|Superiority or Other|||||||0.51|||||||ANOVA|||OV: P value was calculated using ANOVA.|
1758516|NCT00205777|3229651|Superiority or Other|||||||0.33|||||||ANOVA|||OV: P value was calculated using ANOVA.|
1758517|NCT00205777|3229651|Superiority or Other|||||||0.9|||||||ANOVA|||OV: P value was calculated using ANOVA.|
1758518|NCT00205777|3229651|Superiority or Other|||||||0.78|||||||ANOVA|||OV: P value was calculated using ANOVA.|
1758519|NCT00205777|3229651|Superiority or Other|||||||0.11|||||||ANOVA|||BV: P value was calculated using ANOVA.|
1758520|NCT00205777|3229651|Superiority or Other|||||||0.79|||||||ANOVA|||BV: P value was calculated using ANOVA.|
1758521|NCT00205777|3229651|Superiority or Other|||||||0.74|||||||ANOVA|||BV: P value was calculated using ANOVA.|
1758522|NCT00205777|3229651|Superiority or Other|||||||0.19|||||||ANOVA|||BV: P value was calculated using ANOVA.|
1758523|NCT00205777|3229651|Superiority or Other|||||||0.97|||||||ANOVA|||BV: P value was calculated using Analysis of Variance (ANOVA).|
1758524|NCT00205777|3229652|Superiority or Other|||||||0.65|||||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.|
1758525|NCT00205777|3229652|Superiority or Other|||||||0.33|||||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.|
1758526|NCT00205777|3229652|Superiority or Other|||||||0.11|||||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.|
1758527|NCT00205777|3229652|Superiority or Other|||||||0.99|||||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.|
1758528|NCT00205777|3229652|Superiority or Other|||||||0.62|||||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.|
1758529|NCT00205777|3229652|Superiority or Other|||||||0.054|||||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.|
1758530|NCT00205777|3229652|Superiority or Other|||||||0.031|||||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.|
1758531|NCT00205777|3229652|Superiority or Other|||||||0.058|||||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.|
1758532|NCT00205777|3229652|Superiority or Other|||||||0.96|||||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.|
1758533|NCT00205777|3229652|Superiority or Other|||||||0.34|||||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.|
1758534|NCT00205777|3229652|Superiority or Other|||||||0.55|||||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.|
1758535|NCT00205777|3229652|Superiority or Other|||||||0.058|||||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.|
1758536|NCT00205777|3229652|Superiority or Other|||||||0.44|||||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.|
1758537|NCT00205777|3229652|Superiority or Other|||||||1|||||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.|
1758538|NCT00205777|3229652|Superiority or Other|||||||0.65|||||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.|
1758539|NCT00205777|3229652|Superiority or Other|||||||0.86|||||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.|
1758540|NCT00205777|3229652|Superiority or Other|||||||0.22|||||||ANCOVA|||Percent change at Month 36 in Triglycerides: P value was calculated using ANCOVA.|
1758541|NCT00205777|3229652|Superiority or Other|||||||0.33|||||||ANCOVA|||Percent change at Month 24 in Triglycerides: P value was calculated using ANCOVA.|
1758542|NCT00205777|3229652|Superiority or Other|||||||0.26|||||||ANCOVA|||Percent change at Month 12 in Triglycerides: P value was calculated using ANCOVA.|
1758543|NCT00205777|3229652|Superiority or Other|||||||0.85|||||||ANCOVA|||Percent change at Month 6 in Triglycerides: P value was calculated using ANCOVA.|
1758544|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.|
1758545|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.|
1758546|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.|
1758547|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.|
1758548|NCT00205777|3229652|Superiority or Other||||||<|0.4|||||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.|
1758549|NCT00205777|3229652|Superiority or Other||||||<|0.87|||||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.|
1758550|NCT00205777|3229652|Superiority or Other||||||<|0.98|||||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.|
1758551|NCT00205777|3229652|Superiority or Other||||||<|0.81|||||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.|
1758552|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.|
1758553|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.|
1758554|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.|
1758555|NCT00205777|3229652|Superiority or Other||||||<|0.003|||||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.|
1758556|NCT00205777|3229652|Superiority or Other||||||<|0.75|||||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.|
1758557|NCT00205777|3229652|Superiority or Other||||||<|0.47|||||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.|
1758558|NCT00205777|3229652|Superiority or Other||||||<|0.64|||||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.|
1758559|NCT00205777|3229652|Superiority or Other||||||<|0.46|||||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.|
1758560|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in HDL3: P value was calculated using ANCOVA.|
1758561|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in HDL3: P value was calculated using ANCOVA.|
1758562|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in HDL3: P value was calculated using ANCOVA.|
1758563|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in HDL3: P value was calculated using ANCOVA.|
1758564|NCT00205777|3229652|Superiority or Other||||||<|0.75|||||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.|
1758565|NCT00205777|3229652|Superiority or Other||||||<|0.53|||||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.|
1758566|NCT00205777|3229652|Superiority or Other||||||<|0.043|||||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.|
1758567|NCT00205777|3229652|Superiority or Other||||||<|0.12|||||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.|
1758568|NCT00205777|3229652|Superiority or Other||||||<|0.72|||||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.|
1758569|NCT00205777|3229652|Superiority or Other||||||<|0.96|||||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.|
1758570|NCT00205777|3229652|Superiority or Other||||||<|0.93|||||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.|
1758571|NCT00205777|3229652|Superiority or Other||||||<|0.038|||||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.|
1758572|NCT00205777|3229652|Superiority or Other||||||<|0.49|||||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.|
1758573|NCT00205777|3229652|Superiority or Other||||||<|0.57|||||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.|
1758574|NCT00205777|3229652|Superiority or Other||||||<|0.036|||||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.|
1758575|NCT00205777|3229652|Superiority or Other||||||<|0.59|||||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.|
1758576|NCT00205777|3229652|Superiority or Other||||||<|0.29|||||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.|
1758577|NCT00205777|3229652|Superiority or Other||||||<|0.58|||||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.|
1758578|NCT00205777|3229652|Superiority or Other||||||<|0.7|||||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA.|
1758579|NCT00205777|3229652|Superiority or Other||||||<|0.63|||||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.|
1758580|NCT00205777|3229652|Superiority or Other||||||<|0.46|||||||ANCOVA|||Percent change at Month 36 in HDL2: P value was calculated using ANCOVA.|
1758581|NCT00205777|3229652|Superiority or Other||||||<|0.94|||||||ANCOVA|||Percent change at Month 24 in HDL2: P value was calculated using ANCOVA.|
1758582|NCT00205777|3229652|Superiority or Other||||||<|0.1|||||||ANCOVA|||Percent change at Month 12 in HDL2: P value was calculated using ANCOVA|
1758583|NCT00205777|3229652|Superiority or Other||||||<|0.28|||||||ANCOVA|||Percent change at Month 6 in HDL2: P value was calculated using ANCOVA.|
1758584|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.|
1758585|NCT00205777|3229652|Superiority or Other||||||<|0.007|||||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.|
1758586|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.|
1758587|NCT00205777|3229652|Superiority or Other||||||<|0.13|||||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.|
1758588|NCT00205777|3229652|Superiority or Other||||||<|0.15|||||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.|
1758589|NCT00205777|3229652|Superiority or Other||||||<|0.84|||||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.|
1758590|NCT00205777|3229652|Superiority or Other||||||<|0.96|||||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.|
1758591|NCT00205777|3229652|Superiority or Other||||||<|0.083|||||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.|
1758592|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.|
1758593|NCT00205777|3229652|Superiority or Other||||||<|0.012|||||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.|
1758594|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.|
1758595|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.|
1758596|NCT00205777|3229652|Superiority or Other||||||<|0.82|||||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.|
1758597|NCT00205777|3229652|Superiority or Other||||||<|0.6|||||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.|
1758598|NCT00205777|3229652|Superiority or Other||||||<|0.89|||||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.|
1758599|NCT00205777|3229652|Superiority or Other||||||<|0.1|||||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.|
1758600|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in HDL: P value was calculated using ANCOVA.|
1758601|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in HDL: P value was calculated using ANCOVA.|
1758602|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in HDL: P value was calculated using ANCOVA.|
1758603|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in HDL: P value was calculated using ANCOVA.|
1758604|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.|
1758605|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.|
1758606|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.|
1758607|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.|
1758608|NCT00205777|3229652|Superiority or Other||||||<|0.008|||||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.|
1758609|NCT00205777|3229652|Superiority or Other||||||<|0.031|||||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.|
1758610|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.|
1758611|NCT00205777|3229652|Superiority or Other||||||<|0.012|||||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.|
1758612|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.|
1758613|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.|
1758614|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.|
1758615|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.|
1758616|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.|
1758617|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.|
1758618|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.|
1758619|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.|
1758620|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in LDL: P value was calculated using ANCOVA.|
1758621|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in LDL: P value was calculated using ANCOVA.|
1758622|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in LDL: P value was calculated using ANCOVA.|
1758623|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in LDL: P value was calculated using ANCOVA.|
1758624|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.|
1758625|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.|
1758626|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.|
1758627|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.|
1758628|NCT00205777|3229652|Superiority or Other||||||<|0.004|||||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.|
1758629|NCT00205777|3229652|Superiority or Other||||||<|0.055|||||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.|
1758630|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.|
1758631|NCT00205777|3229652|Superiority or Other||||||<|0.009|||||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.|
1758632|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.|
1758633|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.|
1758634|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.|
1758635|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.|
1758636|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.|
1758637|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.|
1758638|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.|
1758639|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.|
1758640|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in total cholesterol: P value was calculated using ANCOVA.|
1758641|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in total cholesterol: P value was calculated using ANCOVA.|
1758642|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in total cholesterol: P value was calculated using ANCOVA.|
1758643|NCT00205777|3229652|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in total cholesterol: P value was calculated using ANCOVA.|
1758644|NCT00205777|3229653|Superiority or Other|||||||0.77|||||||Ranked ANCOVA|||Percent change at Month 84 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758645|NCT00205777|3229653|Superiority or Other|||||||0.034|||||||Ranked ANCOVA|||Percent change at Month 72 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758646|NCT00205777|3229654|Superiority or Other|||||||0.009|||||||Ranked ANCOVA|||Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758647|NCT00205777|3229654|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758648|NCT00205777|3229654|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 60 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758649|NCT00205777|3229654|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758650|NCT00205777|3229655|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758651|NCT00205777|3229655|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758652|NCT00205777|3229655|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758653|NCT00205777|3229655|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758654|NCT00205777|3229655|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758655|NCT00205777|3229655|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758656|NCT00205777|3229655|Superiority or Other||||||<|0.004|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758657|NCT00205777|3229655|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758658|NCT00205777|3229655|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758659|NCT00205777|3229655|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758660|NCT00205777|3229655|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758661|NCT00205777|3229655|Superiority or Other||||||<|0.4|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758662|NCT00205777|3229655|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758663|NCT00205777|3229655|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758664|NCT00205777|3229655|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in C-telopeptide: P value was calculated using Ranked ANCOVA.|
1758665|NCT00205777|3229656|Superiority or Other|||||||0.16|||||||Ranked ANCOVA|||Percent change at Month 84 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758666|NCT00205777|3229656|Superiority or Other|||||||0.037|||||||Ranked ANCOVA|||Percent change at Month 72 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758667|NCT00205777|3229657|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758668|NCT00205777|3229657|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758669|NCT00205777|3229657|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 60 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758670|NCT00205777|3229657|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 36 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758671|NCT00205777|3229658|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758672|NCT00205777|3229658|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758673|NCT00205777|3229658|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758674|NCT00205777|3229658|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758675|NCT00205777|3229658|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 12 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758676|NCT00205777|3229658|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758677|NCT00205777|3229658|Superiority or Other||||||<|0.3|||||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758678|NCT00205777|3229658|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758679|NCT00205777|3229658|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758680|NCT00205777|3229658|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 6 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758681|NCT00205777|3229658|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758682|NCT00205777|3229658|Superiority or Other||||||<|0.93|||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758683|NCT00205777|3229658|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758684|NCT00205777|3229658|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758685|NCT00205777|3229658|Superiority or Other||||||<|0.001|||||||Ranked ANCOVA|||Percent change at Month 3 in osteocalcin: P value was calculated using Ranked ANCOVA.|
1758686|NCT00205777|3229659|Superiority or Other|||||||0.002|||||||ANCOVA|||Percent change at Month 84 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758687|NCT00205777|3229659|Superiority or Other|||||||0.003|||||||ANCOVA|||Percent change at Month 72 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758688|NCT00205777|3229659|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 84 in femoral neck BMD: P value was calculated using ANCOVA.|
1758689|NCT00205777|3229659|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 72 in femoral neck BMD: P value was calculated using ANCOVA.|
1758690|NCT00205777|3229659|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 84 in total hip BMD: P value was calculated using ANCOVA.|
1758691|NCT00205777|3229659|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 72 in total hip BMD: P value was calculated using ANCOVA.|
1758692|NCT00205777|3229659|Superiority or Other||||||<|0.15|||||||ANCOVA|||Percent change at Month 84 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758693|NCT00205777|3229659|Superiority or Other||||||<|0.34|||||||ANCOVA|||Percent change at Month 72 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758694|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758695|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758696|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 60 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758697|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 48 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758698|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.|
1758699|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.|
1758700|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 60 in femoral neck BMD: P value was calculated using ANCOVA.|
1758701|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 48 in femoral neck BMD: P value was calculated using ANCOVA.|
1758702|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.|
1758703|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.|
1758704|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 60 in total hip BMD: P value was calculated using ANCOVA.|
1758705|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 48 in total hip BMD: P value was calculated using ANCOVA.|
1758706|NCT00205777|3229660|Superiority or Other||||||<|0.023|||||||ANCOVA|||Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758707|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758708|NCT00205777|3229660|Superiority or Other||||||<|0.01|||||||ANCOVA|||Percent change at Month 60 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758709|NCT00205777|3229660|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 48 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758710|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758711|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758712|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758713|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758714|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758715|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758716|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758717|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758718|NCT00205777|3229661|Superiority or Other||||||<|0.038|||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758719|NCT00205777|3229661|Superiority or Other||||||<|0.048|||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758720|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758721|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758722|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758723|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1759157|NCT00191139|3230720|Superiority or Other||survival rate|55.7||||||95.0|36.8|70.9|||||||
1758724|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758725|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758726|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758727|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758728|NCT00205777|3229661|Superiority or Other||||||<|0.002|||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758729|NCT00205777|3229661|Superiority or Other||||||<|0.01|||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758730|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758731|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758732|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758733|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758734|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in femoral trochanter BMD: P value was calculated using ANCOVA.|
1758735|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.|
1758736|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.|
1758737|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.|
1758738|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.|
1758739|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.|
1758740|NCT00205777|3229661|Superiority or Other||||||<|0.47|||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.|
1758741|NCT00205777|3229661|Superiority or Other||||||<|0.016|||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.|
1758742|NCT00205777|3229661|Superiority or Other||||||<|0.34|||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.|
1758743|NCT00205777|3229661|Superiority or Other||||||<|0.17|||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.|
1758744|NCT00205777|3229661|Superiority or Other||||||<|0.39|||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.|
1758745|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.|
1758746|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.|
1758747|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.|
1758748|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.|
1758749|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.|
1758750|NCT00205777|3229661|Superiority or Other||||||<|0.004|||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.|
1758751|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.|
1758752|NCT00205777|3229661|Superiority or Other||||||<|0.002|||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.|
1758753|NCT00205777|3229661|Superiority or Other||||||<|0.005|||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.|
1758754|NCT00205777|3229661|Superiority or Other||||||<|0.47|||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.|
1758755|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in femoral neck BMD: P value was calculated using ANCOVA.|
1758756|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in femoral neck BMD: P value was calculated using ANCOVA.|
1758757|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in femoral neck BMD: P value was calculated using ANCOVA.|
1758758|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in femoral neck BMD: P value was calculated using ANCOVA.|
1758759|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in femoral neck BMD: P value was calculated using ANCOVA.|
1758760|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.|
1758761|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.|
1758762|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.|
1758763|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.|
1758764|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.|
1759097|NCT00191724|3230630|Superiority or Other|||||||0.018||||||P-value for Dyspnea 90-Day Follow-Up.|Regression, Linear||||
1758765|NCT00205777|3229661|Superiority or Other||||||<|0.006|||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.|
1758766|NCT00205777|3229661|Superiority or Other||||||<|0.002|||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.|
1758767|NCT00205777|3229661|Superiority or Other||||||<|0.002|||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.|
1758768|NCT00205777|3229661|Superiority or Other||||||<|0.007|||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.|
1758769|NCT00205777|3229661|Superiority or Other||||||<|0.008|||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.|
1758770|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.|
1758771|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.|
1758772|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.|
1758773|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.|
1758774|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.|
1758775|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.|
1758776|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.|
1758777|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.|
1758778|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.|
1758779|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.|
1758780|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in total hip BMD: P value was calculated using ANCOVA.|
1758781|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in total hip BMD: P value was calculated using ANCOVA.|
1758782|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in total hip BMD: P value was calculated using ANCOVA.|
1758783|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in total hip BMD: P value was calculated using ANCOVA.|
1758784|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in total hip BMD: P value was calculated using ANCOVA.|
1758785|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758786|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758787|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758788|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758789|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758790|NCT00205777|3229661|Superiority or Other||||||<|0.002|||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758791|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758792|NCT00205777|3229661|Superiority or Other||||||<|0.019|||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758793|NCT00205777|3229661|Superiority or Other||||||<|0.003|||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758794|NCT00205777|3229661|Superiority or Other||||||<|0.036|||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758795|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758796|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758797|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758798|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758799|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758800|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758801|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758802|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758803|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758804|NCT00205777|3229661|Superiority or Other||||||<|0.018|||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758805|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 36 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758806|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 24 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758807|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 18 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758808|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 12 in lumbar spine BMD: P value was calculated using ANCOVA.|
1758809|NCT00205777|3229661|Superiority or Other||||||<|0.001|||||||ANCOVA|||Percent change at Month 6 in lumbar spine BMD: P value was calculated using Analysis of covariance (ANCOVA).|
1758810|NCT00205777|3229662|Superiority or Other|||||||0.26|||||||ANCOVA||||
1758811|NCT00205777|3229663|Superiority or Other|||||||0.94|||||||ANCOVA||||
1758812|NCT00205777|3229663|Superiority or Other|||||||0.12|||||||ANCOVA||||
1758813|NCT00205777|3229664|Superiority or Other|||||||0.002|||||||ANCOVA||||
1758814|NCT00205777|3229664|Superiority or Other|||||||0.12|||||||ANCOVA||||
1758815|NCT00205777|3229664|Superiority or Other|||||||0.13|||||||ANCOVA||||
1758816|NCT00205777|3229664|Superiority or Other|||||||0.039|||||||ANCOVA||||
1758817|NCT00205777|3229664|Superiority or Other|||||||0.31|||||||ANCOVA||||
1758818|NCT00205777|3229665|Superiority or Other||Hazard Ratio (HR)|1.15||||0.45|2-Sided|95.0|0.8|1.66|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [SE II] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758819|NCT00205777|3229665|Superiority or Other||Hazard Ratio (HR)|0.87||||0.71|2-Sided|95.0|0.41|1.83|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [SE II] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758820|NCT00205777|3229665|Superiority or Other||Hazard Ratio (HR)|0.96||||0.73|2-Sided|95.0|0.78|1.19|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [SE II] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758821|NCT00205777|3229666|Superiority or Other||Hazard Ratio (HR)|1.28||||0.298|2-Sided|95.0|0.818|2.002|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40/20 mg [SE I]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758822|NCT00205777|3229666|Superiority or Other||Hazard Ratio (HR)|0.936||||0.799|2-Sided|95.0|0.587|1.491|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg [SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758823|NCT00205777|3229666|Superiority or Other||Hazard Ratio (HR)|1.202||||0.423|2-Sided|95.0|0.776|1.861|||Log Rank|||Wrist: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758824|NCT00205777|3229666|Superiority or Other||Hazard Ratio (HR)|1.612||||0.371|2-Sided|95.0|0.624|4.161|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40/20 mg [SE I]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758825|NCT00205777|3229666|Superiority or Other||Hazard Ratio (HR)|0.872||||0.82|2-Sided|95.0|0.316|2.405|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg [SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758826|NCT00205777|3229666|Superiority or Other||Hazard Ratio (HR)|1.406||||0.493|2-Sided|95.0|0.566|3.497|||Log Rank|||Hip: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758827|NCT00205777|3229666|Superiority or Other||Hazard Ratio (HR)|1.2||||0.191|2-Sided|95.0|0.925|1.556|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40/20 mg [SE I]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758828|NCT00205777|3229666|Superiority or Other||Hazard Ratio (HR)|0.846||||0.211|2-Sided|95.0|0.652|1.097|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 40/20 mg [SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758829|NCT00205777|3229666|Superiority or Other||Hazard Ratio (HR)|1.012||||0.968|2-Sided|95.0|0.79|1.296|||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758830|NCT00205777|3229667|Superiority or Other|||||||0.11|||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.|
1758831|NCT00205777|3229667|Superiority or Other|||||||0.8|||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.|
1758832|NCT00205777|3229667|Superiority or Other|||||||0.19|||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.|
1758833|NCT00205777|3229667|Superiority or Other|||||||0.59|||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.|
1758834|NCT00205777|3229667|Superiority or Other|||||||0.43|||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.|
1758835|NCT00205777|3229667|Superiority or Other|||||||0.29|||||||Log Rank|||Wrist: P value was calculated using Log-Rank test.|
1758836|NCT00205777|3229667|Superiority or Other|||||||0.76|||||||Log Rank|||Hip: P value was calculated using Log-Rank test.|
1758837|NCT00205777|3229667|Superiority or Other|||||||0.97|||||||Log Rank|||Hip: P value was calculated using Log-Rank test.|
1758838|NCT00205777|3229667|Superiority or Other|||||||0.72|||||||Log Rank|||Hip: P value was calculated using Log-Rank test.|
1758839|NCT00205777|3229667|Superiority or Other|||||||0.17|||||||Log Rank|||Hip: P value was calculated using Log-Rank test.|
1758840|NCT00205777|3229667|Superiority or Other|||||||0.31|||||||Log Rank|||Hip: P value was calculated using Log-Rank test.|
1758841|NCT00205777|3229667|Superiority or Other|||||||0.28|||||||Log Rank|||Hip: P value was calculated using Log-Rank test.|
1759158|NCT00191139|3230720|Superiority or Other||survival rate|40.6||||||95.0|23.8|56.8|||||||
1758842|NCT00205777|3229667|Superiority or Other|||||||0.52|||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.|
1758843|NCT00205777|3229667|Superiority or Other|||||||0.39|||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.|
1758844|NCT00205777|3229667|Superiority or Other|||||||0.84|||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.|
1758845|NCT00205777|3229667|Superiority or Other|||||||0.93|||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.|
1758846|NCT00205777|3229667|Superiority or Other|||||||0.9|||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.|
1758847|NCT00205777|3229667|Superiority or Other|||||||0.46|||||||Log Rank|||Osteoporosis-Related: P value was calculated using Log-Rank test.|
1758848|NCT00205777|3229671|Superiority or Other|||||||0.18|||||||Log Rank||||
1758849|NCT00205777|3229672|Superiority or Other|||||||0.94|||||||Log Rank||||
1758850|NCT00205777|3229672|Superiority or Other|||||||0.31|||||||Log Rank||||
1758851|NCT00205777|3229672|Superiority or Other|||||||0.29|||||||Log Rank||||
1758852|NCT00205777|3229673|Superiority or Other|||||||0.95|||||||Log Rank||||
1758853|NCT00205777|3229673|Superiority or Other|||||||0.89|||||||Log Rank||||
1758854|NCT00205777|3229673|Superiority or Other|||||||0.67|||||||Log Rank||||
1758855|NCT00205777|3229673|Superiority or Other|||||||0.72|||||||Log Rank||||
1758856|NCT00205777|3229673|Superiority or Other|||||||0.62|||||||Log Rank||||
1758857|NCT00205777|3229673|Superiority or Other|||||||0.57|||||||Log Rank||||
1758858|NCT00205777|3229674|Superiority or Other||Relative risk|1.01|||||2-Sided|95.0|0.5|2.06||||||Relative risk versus placebo was provided together with 95% CIs.|
1758859|NCT00205777|3229675|Superiority or Other||Relative Risk|0.92|||||2-Sided|95.0|0.39|2.21||||||Relative risk versus placebo was provided together with 95% CIs.|
1758860|NCT00205777|3229675|Superiority or Other||Relative Risk|0.9|||||2-Sided|95.0|0.38|2.15||||||Relative risk versus placebo was provided together with 95% CIs.|
1758861|NCT00205777|3229676|Superiority or Other||Odds Ratio (OR)|1.238||||0.75|2-Sided|95.0|0.332|4.616|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.|
1758862|NCT00205777|3229676|Superiority or Other||Odds Ratio (OR)|0.85||||0.76|2-Sided|95.0|0.305|2.37|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.|
1758863|NCT00205777|3229676|Superiority or Other||Odds Ratio (OR)|0.661||||0.49|2-Sided|95.0|0.206|2.118|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.|
1758864|NCT00205777|3229676|Superiority or Other||Odds Ratio (OR)|0.54||||0.33|2-Sided|95.0|0.157|1.86|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.|
1758865|NCT00205777|3229676|Superiority or Other||Odds Ratio (OR)|0.504||||0.26|2-Sided|95.0|0.151|1.676|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.|
1758866|NCT00205777|3229676|Superiority or Other||Odds Ratio (OR)|0.621||||0.4|2-Sided|95.0|0.203|1.903|||Regression, Logistic|||P value was calculated using logistic regression. Gail index was added to the model to account for baseline risk differences between participants.|
1758867|NCT00205777|3229677|Superiority or Other||Hazard Ratio (HR)|0.61||||0.004|2-Sided|95.0|0.434|0.857|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [SE II] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758868|NCT00205777|3229677|Superiority or Other||Hazard Ratio (HR)|0.68||||0.085|2-Sided|95.0|0.44|1.052|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [SE II] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758869|NCT00205777|3229678|Superiority or Other||Hazard Ratio (HR)|1.157||||0.5|2-Sided|95.0|0.71|1.885|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40/20 mg [SE I]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758870|NCT00205777|3229678|Superiority or Other||Hazard Ratio (HR)|0.573||||0.014|2-Sided|95.0|0.367|0.896|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg [SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758871|NCT00205777|3229678|Superiority or Other||Hazard Ratio (HR)|0.666||||0.067|2-Sided|95.0|0.435|1.019|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758872|NCT00205777|3229678|Superiority or Other||Hazard Ratio (HR)|0.941||||0.83|2-Sided|95.0|0.493|1.793|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40/20 mg [SE I]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758873|NCT00205777|3229678|Superiority or Other||Hazard Ratio (HR)|0.645||||0.15|2-Sided|95.0|0.361|1.151|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40/20 mg [SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758874|NCT00205777|3229678|Superiority or Other||Hazard Ratio (HR)|0.61||||0.097|2-Sided|95.0|0.339|1.099|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1759098|NCT00191724|3230631|Superiority or Other|||||||0.23||||||P-value for effect of drotrecogin alfa (activated) dose on right ventricular function at Day 90|Regression, Linear||||
1758875|NCT00205777|3229679|Superiority or Other||Hazard Ratio (HR)|0.574||||0.036|2-Sided|95.0|0.34|0.968|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg [Core] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758876|NCT00205777|3229679|Superiority or Other||Hazard Ratio (HR)|0.882||||0.78|2-Sided|95.0|0.488|1.593|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758877|NCT00205777|3229679|Superiority or Other||Hazard Ratio (HR)|0.959||||0.99|2-Sided|95.0|0.527|1.743|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Raloxifene 60 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758878|NCT00205777|3229679|Superiority or Other||Hazard Ratio (HR)|1.085||||0.79|2-Sided|95.0|0.605|1.947|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg [Core] versus Raloxifene 60 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758879|NCT00205777|3229679|Superiority or Other||Hazard Ratio (HR)|0.624||||0.07|2-Sided|95.0|0.373|1.045|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg [Core] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758880|NCT00205777|3229679|Superiority or Other||Hazard Ratio (HR)|0.551||||0.035|2-Sided|95.0|0.324|0.937|||Log Rank|||At Least 1 Prevalent Fracture: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758881|NCT00205777|3229679|Superiority or Other||Hazard Ratio (HR)|0.592||||0.16|2-Sided|95.0|0.289|1.212|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Raloxifene 60 mg [Core] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758882|NCT00205777|3229679|Superiority or Other||Hazard Ratio (HR)|0.988||||0.96|2-Sided|95.0|0.458|2.131|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Bazedoxifene 40 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758883|NCT00205777|3229679|Superiority or Other||Hazard Ratio (HR)|1.074||||0.87|2-Sided|95.0|0.49|2.356|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Raloxifene 60 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758884|NCT00205777|3229679|Superiority or Other||Hazard Ratio (HR)|1.097||||0.83|2-Sided|95.0|0.501|2.405|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg [Core] versus Raloxifene 60 mg [Core]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758885|NCT00205777|3229679|Superiority or Other||Hazard Ratio (HR)|0.647||||0.24|2-Sided|95.0|0.322|1.301|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 40 mg [Core] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% CIs.|
1758886|NCT00205777|3229679|Superiority or Other||Hazard Ratio (HR)|0.647||||0.22|2-Sided|95.0|0.322|1.302|||Log Rank|||No Prevalent Fractures: P value was calculated using stratified log-rank test. Hazard ratio (Bazedoxifene 20 mg [Core+SE I] versus Placebo [Core+SE I+SE II]) based on a Cox proportional hazards regression model was presented along with 95% confidence intervals (CIs).|
1758887|NCT00205699|3229683|Superiority|||||||0.002||||||Bonferroni correction for multiple comparisons was applied (p<0.05/4 = 0.0125).|ANCOVA|Contrasts based on the ANCOVA-derived time by treatment condition interaction.|||
1758888|NCT00205699|3229683|Superiority|||||||0.003||||||Bonferroni correction for multiple comparisons was applied (p<0.05/4 = 0.0125).|Contrast|Contrasts based on the ANCOVA-derived time by treatment condition interaction.|||
1758889|NCT00205699|3229683|Superiority||||||<|0.003|||||||ANCOVA|||Repeated measures ANCOVA was used to test for the main effect of time on the outcome, and to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).|
1758890|NCT00205699|3229684|Superiority|||||||0.29|||||||ANCOVA||||
1758891|NCT00205699|3229685|Superiority|||||||0.17|||||||ANCOVA||||
1758892|NCT00205699|3229686|Superiority|||||||0.27|||||||ANCOVA||||
1758893|NCT00205699|3229687|Superiority|||||||0.07|||||||ANCOVA||||
1758894|NCT00205699|3229688|Superiority||||||<|0.0001||||||The p value refers to the time by treatment condition interaction. The a priori threshold for statistical significance in this planned primary test was p<0.05.|Mixed Models Analysis|||Primary analysis for change in DEXA % fat used a likelihood-based mixed-effects model using time (0, 6 and 12 weeks) and medication group as independent variables, with Toeplitz covariance structure specified, based on Bayesian information criteria (BIC). The null hypotheses were that there was no difference in the outcome over time (main effect of time) and that there were no differences between groups in the change over time (time by treatment condition).|
1758895|NCT00205660|3229689|Superiority|||||||0.01||||||The a priori threshold for statistical significance in this planned primary test was p<0.05.|ANCOVA|||A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).|
1758896|NCT00205660|3229690|Superiority|||||||0.03||||||The a priori threshold for statistical significance in this planned primary test was p<0.05.|ANCOVA|||A repeated measures ANCOVA was used to test for a time by treatment condition interaction that would indicate differences between groups in change over time in the primary outcome. The null hypothesis was that there were no differences between groups in the change over time (time x treatment condition).|
1758897|NCT00205348|3229703|Superiority or Other|||||||0.0332|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Communication was tested with the Wilcoxon signed-rank test.|
1758898|NCT00205348|3229703|Superiority or Other|||||||0.2125|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Social was tested with the Wilcoxon signed-rank test.|
1758899|NCT00205348|3229703|Superiority or Other|||||||0.0002|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Fatigue was tested with the Wilcoxon signed-rank test.|
1758900|NCT00205348|3229703|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Sleep was tested with the Wilcoxon signed-rank test.|
1758901|NCT00205348|3229703|Superiority or Other||||||<|0.0062|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Food Selection was tested with the Wilcoxon signed-rank test.|
1758902|NCT00205348|3229703|Superiority or Other||||||<|0.1772|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Eating Duration was tested with the Wilcoxon signed-rank test.|
1758903|NCT00205348|3229703|Superiority or Other||||||<|0.0973|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Eating Desire was tested with the Wilcoxon signed-rank test.|
1758904|NCT00205348|3229703|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Fear was tested with the Wilcoxon signed-rank test.|
1758905|NCT00205348|3229703|Superiority or Other||||||<|0.0002|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Mental was tested with the Wilcoxon signed-rank test.|
1758906|NCT00205348|3229703|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Physical was tested with the Wilcoxon signed-rank test.|
1758907|NCT00205348|3229703|Superiority or Other||||||<|0.0007|||||||Wilcoxon (Mann-Whitney)|||The statistical significance of the difference between pre-and post-operative scores for Burden was tested with the Wilcoxon signed-rank test.|
1758908|NCT00204932|3229735|Superiority||||||<|0.05|||||||ANOVA|||Pre- post treatment comparison o fat oxidation found that fat oxidation increased in CLA (4 +/- 8 g) and decreased in placebo (-7 +/- 11 g) groups during sleep. after 6 mo of supplementation.|
1758909|NCT00204932|3229735|Non-Inferiority or Equivalence|Power analysis was based on test-retest variance of body fat mass measure by DEXA|||||<|0.05|||||||ANOVA|||Analysis of variance to test CLA not equal to placebo|
1758910|NCT00204737|3229744|Other|||||||0.5|||||||Fisher Exact|||Comparison at 12 weeks|
1758911|NCT00204737|3229744|Other|||||||0.18|||||||Fisher Exact|||Comparison at 6 Weeks|
1758912|NCT00204737|3229744|Other|||||||0.06|||||||Fisher Exact|||comparison at 2 Weeks|
1758913|NCT00203931|3229764|Superiority or Other|||||||0.029|||||||Log Rank||||
1758914|NCT00203931|3229765|Superiority or Other|||||||0.046|||||||Wilcoxon-Gehan test||||
1758915|NCT00203931|3229766|Superiority or Other|||||||0.24|||||||Fisher Exact||||
1758916|NCT00203931|3229767|Superiority or Other|||||||0.91|||||||Wilcoxon-Gehan test||||
1758917|NCT00203931|3229768|Superiority or Other|||||||0.11|||||||Log Rank||||
1758918|NCT00203892|3229769|Superiority or Other||||||>|0.99|||||||Fisher Exact||||
1758919|NCT00203892|3229770|Superiority or Other|||||||0.028|||||||Wilcoxon (Mann-Whitney)||||
1758920|NCT00203294|3229794|Superiority or Other||||||<|0.01|||||||Fisher Exact|Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.||Fisher’s exact test was used to compare nominal variables between groups.|
1758921|NCT00203294|3229794|Superiority or Other||||||<|0.01||||||Separate models were fit to the change scores for headache pain, nausea and vomiting, photophobia, phonophobia, and neck pain.|Fisher Exact|||Fisher’s exact test was used to compare nominal variables between groups. The Wilcoxon rank-sum test was used to compare interval and ordinal variables between groups.|
1758922|NCT00203268|3229795|Superiority or Other|||||||0.3025|||||||clustered survival analysis||||
1758923|NCT00203047|3229820|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.11820976||0.8023|2-Sided|95.0|-0.26|0.2|||ANCOVA||||
1758924|NCT00202878|3229823|Superiority or Other||Hazard Ratio (HR)|0.945||||0.035|2-Sided|95.0|0.897|0.996|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment|Model includes events from randomization to last study visit.||
1758925|NCT00202878|3229824|Superiority or Other||Hazard Ratio (HR)|0.912||||0.016|2-Sided|95.0|0.847|0.983|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.||
1758926|NCT00202878|3229825|Superiority or Other||Hazard Ratio (HR)|0.948||||0.035|2-Sided|95.0|0.903|0.996|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.||
1758927|NCT00202878|3229826|Superiority or Other||Hazard Ratio (HR)|0.936||||0.016|2-Sided|95.0|0.887|0.988|||Cox proportional hazard model|Covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment.|Model includes events from randomization to last study visit.||
1758928|NCT00202839|3229828|Superiority or Other|||||||0.1651|||||||Chi-squared||||
1758929|NCT00202644|3229838|Non-Inferiority or Equivalence|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was > -100 x 10^9/Liter.|Least Square Mean|-68.3|Standard Error of the Mean|43.83|||2-Sided|95.0|-154.95|18.43||||||Month 36|
1759032|NCT00192647|3230531|Superiority or Other||Odds Ratio (OR)|1.16||||0.2893|2-Sided|95.0|0.88|1.52|||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by viral load and country|||
1758930|NCT00202644|3229838|Non-Inferiority or Equivalence|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was > -100 x 10^9/Liter.|Least Square Mean|-113.1|Standard Error of the Mean|37.56|||2-Sided|95.0|-187.4|-38.83||||||Month 3|
1758931|NCT00202644|3229839|Non-Inferiority or Equivalence|Noninferiority of anagrelide could be concluded if lower limit of 95% Confidence Interval for the difference between treatment groups (Hydroxyurea - Anagrelide) was > -100 x 10^9/Liter.|Least Square Mean|-100.5|Standard Error of the Mean|39.93|||2-Sided|95.0|-179.42|-21.49|||||||
1758932|NCT00201864|3229849|Superiority or Other|||||||0.9102|||||||Wilcoxon (Mann-Whitney)||||
1758933|NCT00201643|3229881|Superiority or Other||Odds Ratio (OR)|0.45|Standard Error of the Mean|0.1162||0.002|2-Sided|95.0|0.27|0.75||Analysis were also conducted in all randomized women with a known outcome & in randomized treatment group(modified intent to treat). Analysis of the primary outcome used a repeated measures approach where each baby was considered a repeated measure|Fisher Exact|||Our Hypothesis was that administration of a rescue ACS would show a 40% reduction in incidence of composite neonatal morbity in patients delivering < 34 weeks. Sample size estimates based on composite morbidity of 28%. Each arm required 217 subjects to have 80% power to detect a 40% reduction to 16.8%(2-tailed,alpha =0.05)using comparison for proportions/groups(Fisher exact test) OR,95% CI & P values were determined using a repeated measure model where each twin is considered a repeat measure.|
1758934|NCT00201201|3229900|Superiority or Other||||||<|0.1|||||||t-test, 2 sided|||Analyzed at 0 and 12 weeks.|
1758935|NCT00201201|3229901|Superiority or Other|||||||0.0431|||||||t-test, 2 sided||||
1758936|NCT00201201|3229902|Superiority or Other|||||||0.0001|||||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.|
1758937|NCT00201201|3229903|Superiority or Other|||||||0.0001|||||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.|
1758938|NCT00201201|3229904|Superiority or Other|||||||0.0204|||||||ANOVA|||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use.|
1758939|NCT00201201|3229905|Superiority or Other|||||||0.035|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel statistic (1,161)=4.44,p=0.035).||Repeated measures linear-mixed model ANOVA methodology was employed as each participant was measured on 4 visits and the 4 repeated measures are likely dependent. We used study group (intervention vs. control) and visit as categorical variables and controlled for gender, age, APRN, income, education, computer use. Non-parametric tests (Cochran-Mantel-Haenszel statistic), based on rank scores, controlling for participant code were used for the transformed behavior risk scores within groups.|
1758940|NCT00200967|3229910|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.12||0.89||95.0|-0.23|0.26|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for ACQ.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.|
1758941|NCT00200967|3229911|Superiority or Other||Mean Difference (Final Values)|1.32|Standard Error of the Mean|0.45||0.004||95.0|0.43|2.21|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for methacholine PC20.|A mixed-effects linear model was applied to the base-2 logarithm of the methacholine PC20 to account for the repeated measurements within each treatment period of the crossover design.|
1758942|NCT00200967|3229912|Superiority or Other||Mean Difference (Final Values)|-0.07|Standard Error of the Mean|0.24||0.79||95.0|-0.56|0.43|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for EBC.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.|
1758943|NCT00200967|3229913|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.08||0.13||95.0|-0.04|0.31|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for eNO.|A mixed-effects linear model was applied to the natural logarithm of eNO to account for the repeated measurements within each treatment period of the crossover design.|
1758944|NCT00200967|3229914|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|7.0||0.93||95.0|-15.0|14.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry PEF rate, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.|
1758945|NCT00200967|3229915|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.03||0.91||95.0|-0.08|0.07|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry FVC, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.|
1758946|NCT00200967|3229916|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.03||0.34||95.0|-0.1|0.03|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for Spirometry FEV1, pre-bronchodilator.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.|
1759033|NCT00192023|3230562|Superiority or Other|||||||0.061||||||P-value for ADHD Index Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA||||
1759159|NCT00191113|3230721|Superiority or Other||||||||||||||||||
1758947|NCT00200967|3229917|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.1||0.25||95.0|-0.1|0.2|||Wilcoxon (Mann-Whitney)||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for rescue medication use.|A mixed-effects linear model was attempted but could not converge because very few usages of rescue medications were recorded, so a nonparametric analysis was applied.|
1758948|NCT00200967|3229918|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.02||0.09||95.0|-0.02|0.07|||Wilcoxon (Mann-Whitney)||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for asthma symptoms.|A mixed-effects linear model was attempted but could not converge because very few symptoms were recorded, so a nonparametric analysis was applied.|
1758949|NCT00200967|3229919|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|0.5||0.31||95.0|-1.6|0.5|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for PEF variability.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.|
1758950|NCT00200967|3229920|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|7.0||0.82||95.0|-15.0|12.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for PM PEF rate.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design.|
1758951|NCT00200967|3229921|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|7.0||0.99||95.0|-14.0|14.0|||Mixed Models Analysis||The comparison represents the difference between Arg/Arg and Gly/Gly participants based on the change between placebo salmeterol and active salmeterol for AM PEF rate.|A mixed-effects linear model was applied to account for the repeated measurements within each treatment period of the crossover design. A sample size of 40 participants per genotype was required to detect a difference of 25 L/min in AM PEF (and relevant effect sizes for secondary outcomes) with a two-sided, 0.05 significance level test with 90% statistical power and a 15% drop-out rate.|
1758952|NCT00200057|3229948|Superiority or Other||Proportion|0.71|||<|0.0001|2-Sided|95.0|0.62|0.79||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.|
1758953|NCT00200057|3229949|Superiority or Other||||||<|0.0001||||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test||||
1758954|NCT00200057|3229950|Superiority or Other||||||<|0.0001||||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test||||
1758955|NCT00200057|3229951|Superiority or Other||||||<|0.0001||||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test||||
1758956|NCT00200057|3229952|Superiority or Other||||||<|0.0001||||||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Wilcoxon signed-rank test||||
1758957|NCT00200057|3229953|Superiority or Other||Proportion|0.73|||<|0.0001|2-Sided|95.0|0.64|0.81||The Hochberg procedure for multiplicity adjustment was used for all secondary objectives.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.|
1758958|NCT00200057|3229954|Superiority or Other||Proportion|0.73|||<|0.0001|2-Sided|95.0|0.64|0.81||No multiplicity adjustments were made for the primary outcome analysis. Two-tailed p-values were considered statistically significant if they were less than 0.05.|Exact Binomial|||The exact Binomial test (two-sided) for one-sample proportions was used to test the null hypothesis that the success rate is equal to 0.5.|
1758959|NCT00198822|3229965|Superiority or Other||Risk Ratio (RR)|0.65||||0.05|1-Sided|95.0||0.99||We set an a priori level of statistical significance of p equal to 0.05.|generalized estimating equations|RR with 95% CIs were estimated by GEE binomial regression, with a log link function and exchangeable correlation appropriate for binary data.|The vitamin A group and the Beta-carotene group were compared to the placebo group.|Sample size was based on an expected placebo group MR of 600/100,000 pregnancies, requiring 18,000 pregnancies to detect a 35% reduction in all-cause mortality, with a 5% type I error, 80% power, 1.21 design effect, 15% early pregnancy loss and 10% loss to follow-up. A mid-study DSMB analysis suggested a lower MR, leading the SS to be increased to 67,740. However, with no mortality difference evident at a DSMB meeting in Dec 2006, the trial was halted leaving 59,721 in the trial cohort.|
1758960|NCT00197496|3229994|Superiority or Other||Mean Difference (Net)|2.8||||0.4|2-Sided|95.0|-3.6|9.2|||Regression, Linear||||
1758961|NCT00197496|3229997|Superiority or Other||Mean Difference (Net)|-26.3|||<|0.05|2-Sided|95.0|-72.1|19.6|||Regression, Linear||||
1758962|NCT00197106|3230080|Non-Inferiority or Equivalence|Non-inferiority is considered to be shown if the upper limit of the one-sided 95% confidence interval of the difference uflixotide-useretide does not exceed +15% (uflixotide-useretide represent the mean percentages of asthma symptom-free days of the two respective treatment groups).|Adjusted difference|2.6||||0.63||95.0|-8.1|13.4|||Repeated Measurements Anal. of Variance|Anal. = Analysis|||
1758963|NCT00197002|3230128|Non-Inferiority or Equivalence|"The standardized two-sided 95% CI for the GMC ratio (Havrix+Prevnar Group divided by Havrix Group) was computed. The anti-HAV GMC in the Havrix+Prevnar Group was considered as non-inferior to the anti-HAV GMC in the Havrix Group if the lower limit of the 95% CI was not lower than (≥) 0.5.~The non-inferiority of the anti-HAV immune response in Havrix+Prevnar Group compared to Havrix Group was concluded if both non-inferiority criteria (for seropositivity rates and GMCs) were met."|Adjusted GMC ratio|0.91|||||2-Sided|95.0|0.63|1.31||||||To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10).|
1759034|NCT00192023|3230562|Superiority or Other|||||||0.051||||||P-value for Hyperactivity Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA||||
1758964|NCT00197002|3230129|Non-Inferiority or Equivalence|"The two-sided standardized asymptotic 95% confidence interval (CI) for the difference in seropositivity rates [Havrix+Prevnar Group minus Havrix Group] was computed. The anti-HAV seropositivity rates in the Havrix+Prevnar Group were considered as non-inferior to the seropositivity rates in the Havrix Group, if the lower limit of the 95% CI was not lower (≥) than –5%.~The non-inferiority was concluded if both non-inferiority criteria (for seropositivity rates and GMCs) were met."|Difference in seropositivity rate|-1.06|||||2-Sided|95.0|-5.78|2.45||||||"Difference in seropositivity rates for anti-HAV:~To demonstrate the non-inferiority of Havrix® vaccine co-administered with Prevnar™ vaccine (Havrix+Prevnar Group), compared to Havrix® vaccine administered alone (Havrix Group), in terms of seropositivity rates and geometric mean concentrations (GMCs) for anti-HAV antibody, one month after Dose 2 of Havrix® vaccine (Month 7-10)."|
1758965|NCT00196937|3230173|Non-Inferiority|Non-inferiority with respect to seroconversion was shown if, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference [Cervarix (15-25 years) Group minus Cervarix (26-45 years) Group] was below 10%.|Difference in SCR|0.0|||||2-Sided|95.0|-1.87|2.03||||||Immune response to anti-HPV-18 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 – 45 years of age is non-inferior to that in women 15 – 25 years of age.|
1758966|NCT00196937|3230173|Non-Inferiority|Non-inferiority with respect to seroconversion was shown if, for both anti-HPV-16 and anti-HPV-18 antibodies, the upper limit of the 95% confidence interval (CI) for the difference [Cervarix (15-25 years) Group minus Cervarix (26-45 years) Group] was below 10%.|Difference in SCR|0.0|||||2-Sided|95.0|-1.97|2.29||||||Immune response to anti-HPV-16 in terms of SCR: To evaluate if the immunogenicity (as determined by ELISA) of the Cervarix vaccine, one month after the third dose (Month 7), in young women 26 – 45 years of age is non-inferior to that in women 15 – 25 years of age.|
1758967|NCT00196105|3230189|Superiority or Other|||||||0.69|||||||Kruskal-Wallis||||
1758968|NCT00196105|3230189|Superiority or Other|||||||0.32|||||||Log Rank||||
1758969|NCT00196105|3230191|Superiority or Other|||||||0.16|||||||ANOVA||||
1758970|NCT00196105|3230192|Superiority or Other|||||||0.02||||||P-value is adjusted for multiple comparisons.|Chi-squared|||6 mm Zilver vs. 10 mm Zilver and 10 mm Wallstent combined|
1758971|NCT00196105|3230192|Superiority or Other|||||||0.69|||||||Chi-squared||||
1758972|NCT00196105|3230192|Superiority or Other|||||||0.007||||||Death is censored for Kaplan-Meier analysis.|Log Rank||||
1758973|NCT00196105|3230192|Superiority or Other|||||||0.04|||||||Chi-squared||||
1758974|NCT00196105|3230193|Superiority or Other|||||||0.057|||||||Log Rank||||
1758975|NCT00195819|3230194|Superiority or Other||Mean Difference (Net)|-0.4|Standard Error of the Mean|0.42||0.387||95.0|||||ANCOVA||||
1758976|NCT00195819|3230237|Superiority or Other||Odds Ratio (OR)|20.1||||0.06||95.0|-0.5|40.7|||Chi-squared||||
1758977|NCT00195702|3230278|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1758978|NCT00195702|3230278|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1758979|NCT00195702|3230282|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1758980|NCT00195702|3230282|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1758981|NCT00195702|3230284|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1758982|NCT00195702|3230284|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1758983|NCT00195702|3230285|Superiority or Other||||||<|0.001||||||Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.|
1758984|NCT00195702|3230285|Superiority or Other||||||<|0.001||||||Normality was evaluated by applying the Shapiro-Wilk test to residuals from the parametric model. The final analysis was performed using a parametric approach.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change from baseline in the HAQ at Week 52 tested last. The difference among all treatment groups was assessed using ANCOVA with the baseline value as the covariate. If this was significant (p<=0.05), pairwise comparisons between each adalimumab dose group and placebo were evaluated using the same method.|
1758985|NCT00195702|3230286|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1758986|NCT00195702|3230286|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1758987|NCT00195702|3230287|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1758988|NCT00195702|3230287|Superiority or Other||||||<|0.01|||||||ANCOVA||||
1758989|NCT00195702|3230288|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1758990|NCT00195702|3230288|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1758991|NCT00195702|3230289|Superiority or Other||||||<|0.001||||||An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.|
1758992|NCT00195702|3230289|Superiority or Other||||||<|0.001||||||An ANCOVA model with baseline erosion scores as the covariate was performed. An overall significance test at alpha =0.05 was done. Pairwise comparisons, each at alpha =0.05 (2-sided), were performed if the overall test was significant.|ANCOVA|||The 3 primary efficacy variables were considered in a hierarchical order, with the change in modified total Sharp x-ray score at Week 52 tested second. Normality was evaluated by applying the Shapiro-Wilk test procedure to the residuals from the parametric model. The final analysis was performed following a non-parametric approach, ranking the results prior to fitting the model.|
1759093|NCT00191724|3230630|Superiority or Other|||||||0.068||||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear||||
1758993|NCT00195702|3230290|Superiority or Other||||||<|0.001|||||||Chi-squared|||The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson’s chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.|
1758994|NCT00195702|3230290|Superiority or Other||||||<|0.001|||||||Chi-squared|||The 3 primary efficacy variables were considered in a hierarchical order, with the ACR20 response tested first. The ACR20 response rate at Week 24 was initially assessed using Pearson’s chi-squared test at a significance level of 0.05. If significant, pairwise comparisons between each adalimumab dose group and the placebo group were performed.|
1758995|NCT00195663|3230324|Superiority or Other|||||||0.5402|||||||Wilcoxon (Mann-Whitney)||||
1758996|NCT00195663|3230325|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1758997|NCT00195663|3230326|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1758998|NCT00195663|3230327|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1758999|NCT00195663|3230328|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1759000|NCT00195663|3230329|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1759001|NCT00195663|3230330|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1759002|NCT00195663|3230331|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)|||Statistical tests were performed in a hierarchical manner. If there was a statistically significant difference in favor of adalimumab + MTX combination treatment on the ACR50 response, the second primary analysis of modified TSS would be performed.|
1759003|NCT00195663|3230332|Superiority or Other||||||<|0.001||||||Statistical tests were performed in a hierarchical manner. If there was a statistically significant difference in favor of adalimumab + MTX combination treatment, the second primary analysis of the modified Total Sharp Score was to be performed.|Chi-squared, Corrected|||The study was powered to demonstrate the superiority of adalimumab + MTX combination therapy vs. MTX monotherapy in the proportion of subjects who achieved an ACR50 response at 52 weeks. Power calculations were based on 250 subjects in each group using a chi-squared test with a continuity correction and an alpha = 0.05 significance level. With 250 subjects in each group, a difference of 0.13 in response rates could be detected with 80% power.|
1759004|NCT00195507|3230345|Superiority or Other|||||||0.143|||||||Fisher Exact||||
1759005|NCT00195507|3230347|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1759006|NCT00195507|3230348|Superiority or Other||Mean Difference (Net)|-0.53|||<|0.001||95.0|-0.64|-0.43|||ANCOVA|Treatment and center as main effects, and baseline score as a covariant.|||
1759007|NCT00195494|3230350|Superiority or Other||Risk Difference (RD)|21.0|||<|0.001|||||||Fisher Exact||E+M (79.7%) - M (58.7%) creates the risk difference estimated value.||
1759008|NCT00195494|3230351|Superiority or Other||Risk Difference (RD)|22.0|||<|0.001|||||||Fisher Exact||E+M (49.8%) - M (27.8%) creates the risk difference estimated value.||
1759009|NCT00195429|3230366|Superiority or Other|||||||0.361|||||||Student's t-test||||
1759010|NCT00195429|3230367|Superiority or Other|||||||1|||||||Fisher Exact||||
1759011|NCT00195403|3230368|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from baseline in number of joints with tenderness, pain, and limitation of motion or swelling at Month 3 were evaluated using paired t-test.|
1759012|NCT00195403|3230369|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||Change from baseline in PGA at Month 3 was evaluated using paired t-test.|
1759013|NCT00195351|3230371|Superiority or Other||Risk Difference (RD)|-2.9||||0.015||95.0|-13.9|8.1|||Method of Mehrotra and Railkar||||
1759014|NCT00195351|3230372|Superiority or Other||Risk Difference (RD)|-3.4||||0.02||95.0|-14.5|7.8|||t-test, 2 sided||||
1759015|NCT00195351|3230373|Superiority or Other||Risk Difference (RD)|-4.0||||0.009||95.0|-13.1|5.1|||t-test, 2 sided||||
1759016|NCT00195273|3230379|Superiority or Other|||||||0.4662|||||||ANOVA|Calculated for 3 month analysis|||
1759017|NCT00195273|3230382|Superiority or Other|||||||0.6081||||||Calculated for 12 month analysis|ANOVA|Analysis of variance with treatment group and center as factors|||
1759018|NCT00194025|3230457|Superiority or Other|||||||0.21|||||||t-test, 2 sided|||The t-test was applied to the values at baseline vs. the values at 12 weeks.|
1759019|NCT00194025|3230458|Superiority or Other|||||||0.199|||||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.|
1759020|NCT00194025|3230459|Superiority or Other|||||||0.038|||||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.|
1759021|NCT00194025|3230460|Superiority or Other|||||||0.569|||||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.|
1759022|NCT00194025|3230461|Superiority or Other|||||||0.027|||||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.|
1759023|NCT00194025|3230462|Superiority or Other|||||||0.017|||||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.|
1759024|NCT00194025|3230463|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.|
1759025|NCT00194025|3230464|Superiority or Other|||||||0.585|||||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.|
1759026|NCT00194025|3230465|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||The 1 sided t-test was applied to the scores at baseline vs. the scores at 12 weeks.|
1759027|NCT00192647|3230529|Superiority or Other||Odds Ratio (OR)|1.46|||||2-Sided|95.0|1.08|1.98||||||Week 24|
1759028|NCT00192647|3230529|Superiority or Other||Odds Ratio (OR)|1.88|||||2-Sided|95.0|1.4|2.53||||||Week 12|
1759029|NCT00192647|3230529|Superiority or Other||Odds Ratio (OR)|1.64|||||2-Sided|95.0|1.24|2.17||||||Week 8|
1759030|NCT00192647|3230529|Superiority or Other||Odds Ratio (OR)|1.68|||||2-Sided|95.0|1.24|2.27||||||Week 4|
1759031|NCT00192647|3230530|Superiority or Other||Odds Ratio (OR)|1.22|||||2-Sided|95.0|0.91|1.63|||||||
1759094|NCT00191724|3230630|Superiority or Other|||||||0.161||||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear||||
1759035|NCT00192023|3230562|Superiority or Other|||||||0.113||||||P-value for Cognitive Problems Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA||||
1759036|NCT00192023|3230562|Superiority or Other|||||||0.002||||||P-value for Oppositional Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA||||
1759037|NCT00192023|3230563|Superiority or Other|||||||0.071||||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA||||
1759038|NCT00192023|3230564|Superiority or Other||||||<|0.001||||||P-value for ADHD Index Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA||||
1759039|NCT00192023|3230564|Superiority or Other||||||<|0.022||||||P-value for Hyperactivity Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA||||
1759040|NCT00192023|3230564|Superiority or Other||||||<|0.001||||||P-value for Cognitive Problems Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA||||
1759041|NCT00192023|3230564|Superiority or Other||||||<|0.002||||||P-value for Oppositional Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA||||
1759042|NCT00192023|3230565|Superiority or Other|||||||0.87||||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA||||
1759043|NCT00192023|3230566|Superiority or Other|||||||0.836||||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA||||
1759044|NCT00192023|3230567|Superiority or Other|||||||0.001||||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA||||
1759045|NCT00192023|3230568|Superiority or Other||||||<|0.001||||||P-value for Change to 8 Week Endpoint. Change = Endpoint minus baseline. Model: Change to 8 Week Endpoint=Score at 8 weeks+treatment+site.|ANCOVA||||
1759046|NCT00192023|3230569|Superiority or Other||||||<|0.001||||||P-value for Change to Week 8 Endpoint. Change = Endpoint minus baseline. Model: Change to Week 8=score at Week 8+treatment+site+treatment-by-site interaction. If treatment-by-site interaction isn't significant it will be removed from model.|ANCOVA|||Using an estimate of the common standard deviation of 13 points, the planned sample size will give about 80% power to detect a difference between the groups of 8 points on the SNAP-IV. The sample size was determined using a two-sided test with p=0.05, and assumes that up to 10% of patients will discontinue the study without providing post-baseline efficacy data in Study Period III.|
1759047|NCT00191945|3230581|Superiority or Other||Mean Difference (Net)|0.99||||0.541||95.0|-2.21|4.19||P-value for Child/Adolescent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.|
1759048|NCT00191945|3230581|Superiority or Other||Mean Difference (Net)|3.56||||0.006||95.0|1.04|6.08||P-value for Child/Adolescent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.|
1759049|NCT00191945|3230581|Superiority or Other||Mean Difference (Net)|0.16||||0.91||95.0|-2.59|2.9||P-value for Child/Adolescent:Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.|
1759050|NCT00191945|3230581|Superiority or Other||Mean Difference (Net)|0.92||||0.452||95.0|-1.49|3.34||P-value for Child/Adolescent:Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.|
1759051|NCT00191945|3230581|Superiority or Other||Mean Difference (Net)|-1.36||||0.323||95.0|-4.06|1.35||P-value for Child/Adolescent:Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.|
1759052|NCT00191945|3230581|Superiority or Other||Mean Difference (Net)|3.39||||0.042||95.0|0.13|6.65||P-value for Parent:Achievement difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.|
1759053|NCT00191945|3230581|Superiority or Other||Mean Difference (Net)|8.41|||<|0.001||95.0|4.27|12.55||P-value for Parent:Risk Avoidance difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.|
1759054|NCT00191945|3230581|Superiority or Other||Mean Difference (Net)|1.56|||<|0.419||95.0|-2.26|5.39||P-value for Parent: Resilience difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.|
1759055|NCT00191945|3230581|Superiority or Other||Mean Difference (Net)|1.96|||<|0.243||95.0|-1.35|5.29||P-value for Parent: Comfort difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.|
1759056|NCT00191945|3230581|Superiority or Other||Mean Difference (Net)|0.47|||<|0.81||95.0|-3.39|4.33||P-value for Parent: Satisfaction difference (Atomoxetine - Placebo) in the change from 12 weeks minus baseline.|ANCOVA|||ANCOVA model: Dependent variable=standardized mean scores of domain at Visit 7 minus scores at Visit 1; Factors=Treatment, Investigator, Rater; Covariate=standardized mean scores of domain at Visit 1. Both treatment by rater and treatment by covariate interaction terms included in model.|
1759057|NCT00191945|3230582|Superiority or Other||Mean Difference (Net)|-10.7|Standard Error of the Mean|2.3|<|0.001||95.0|-15.1|-6.2||P-value is for the difference between groups in the change from 12 weeks minus baseline.|Mixed Models Analysis|mixed model repeated measures analyis: treatment, visit, patient, and CPRS-R: S Total score at baseline as covariate, with treatment*visit interaction|Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from baseline to 12 weeks.||
1759058|NCT00191945|3230585|Superiority or Other||Mean Difference (Net)|-2.7|Standard Error of the Mean|1.1||0.013||95.0|-4.9|-0.6||P-value is for the difference between groups in the change from 12 weeks minus 6 weeks.|Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference between groups (Atomoxetine - Placebo) in change from 6 weeks to 12 weeks|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.|
1759059|NCT00191945|3230586|Superiority or Other||Mean Difference (Net)|-3.8|Standard Error of the Mean|1.3||0.0033||95.0|-6.4|-1.3|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at 4 weeks (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.|
1759060|NCT00191945|3230587|Superiority or Other||Mean Difference (Net)|-5.2|Standard Error of the Mean|1.5||0.0009||95.0|-8.2|-2.2|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at 6 weeks (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.|
1759061|NCT00191945|3230588|Superiority or Other||Mean Difference (Net)|-6.5|Standard Error of the Mean|1.5|<|0.001||95.0|-9.5|-3.6|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at Week 9 (Atomoxetine - Placebo)|A gatekeeper strategy was employed for sequentially testing the secondary hypotheses using a REML-based Mixed-Model Repeated Measures (MMRM) technique as defined for the primary efficacy analyses. If primary hypothesis is significant at 0.05 (2-sided), first secondary hypothesis will be tested at Visit 6 from MMRM. If comparison is significant, subsequent secondary hypotheses will be tested in sequence until first null hypothesis fails to be rejected.|
1759062|NCT00191945|3230589|Superiority or Other||Mean Difference (Net)|-7.9|Standard Error of the Mean|1.6|<|0.001||95.0|-11.0|-4.8|||Mixed Models Analysis|Mixed Model Repeated Measures analysis method: treatment, study site, visit, treatment-by-visit interaction, baseline, baseline-by-visit interaction.|Least Squares Mean difference at week 12 (Atomoxetine minus Placebo)||
1759063|NCT00191906|3230590|Superiority or Other|||||||0.179||||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.|
1759064|NCT00191906|3230590|Superiority or Other|||||||0.07||||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for ADHD-C+RD versus RD controls.|
1759065|NCT00191906|3230591|Superiority or Other|||||||0.663||||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for RD versus RD controls.|
1759066|NCT00191906|3230591|Superiority or Other|||||||0.302||||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.|
1759067|NCT00191906|3230592|Superiority or Other|||||||0.769||||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariate for ADHD-C versus normal controls|
1759068|NCT00191906|3230593|Superiority or Other|||||||0.508||||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C versus normal controls.|
1759095|NCT00191724|3230630|Superiority or Other|||||||0.481||||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear||||
1759096|NCT00191724|3230630|Superiority or Other|||||||0.72||||||P-value for Emotional 90 Day Follow-up.|Regression, Linear||||
1759069|NCT00191906|3230594|Superiority or Other|||||||0.312||||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction|||
1759070|NCT00191906|3230595|Superiority or Other|||||||0.094||||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.|||
1759071|NCT00191906|3230596|Superiority or Other||||||<|0.001||||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.|
1759072|NCT00191906|3230597|Superiority or Other||||||<|0.001||||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.|
1759073|NCT00191906|3230598|Superiority or Other||||||<|0.001||||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.|
1759074|NCT00191906|3230599|Superiority or Other||||||<|0.001||||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.|
1759075|NCT00191906|3230600|Superiority or Other|||||||0.003||||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for study arm, treatment sequence, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.|
1759076|NCT00191906|3230601|Superiority or Other|||||||0.097||||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.|
1759077|NCT00191906|3230602|Superiority or Other|||||||0.005||||||P-value for Overall. There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment by study-arm-interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.|
1759078|NCT00191906|3230603|Superiority or Other|||||||0.144||||||There were no adjustments for multiple comparisons - not applicable. All statistical tests are performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for RD versus RD controls.|
1759079|NCT00191906|3230603|Superiority or Other|||||||0.579||||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C+RD versus RD controls.|
1759080|NCT00191906|3230604|Superiority or Other|||||||0.97||||||There were no adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|ANCOVA|||ANCOVA model with baseline value, study arm as covariates for ADHD-C versus Normal controls.|
1759081|NCT00191906|3230605|Superiority or Other|||||||0.504||||||P-value for Overall. No adjustments for multiple comparisons - not applicable. All statistical tests were performed using a 0.05 significance level.|Repeated Measures|Repeated measures model including terms for baseline, study arm, treatment sequence, visit, treatment, and treatment-by-study-arm interaction.||Least Squares Mean (LSMean) values were calculated from the measurements taken at baseline and at the end of each 4 week therapy period.|
1759082|NCT00191724|3230630|Superiority or Other|||||||0.394||||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear||||
1759083|NCT00191724|3230630|Superiority or Other|||||||0.774||||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear||||
1759084|NCT00191724|3230630|Superiority or Other|||||||0.141||||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear||||
1759085|NCT00191724|3230630|Superiority or Other|||||||0.149||||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear||||
1759086|NCT00191724|3230630|Superiority or Other|||||||0.963||||||P-value for Mastery 90 Day Follow-Up.|Regression, Linear||||
1759087|NCT00191724|3230630|Superiority or Other|||||||0.797||||||P-value for Fatigue 90 Day Follow-Up.|Regression, Linear||||
1759088|NCT00191724|3230630|Superiority or Other|||||||0.841||||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear||||
1759089|NCT00191724|3230630|Superiority or Other|||||||0.848||||||P-value for Dyspnea 90 Day Follow-Up.|Regression, Linear||||
1759090|NCT00191724|3230630|Superiority or Other|||||||0.273||||||P-value for Mastery 90 Day Follow-Up|Regression, Linear||||
1759091|NCT00191724|3230630|Superiority or Other|||||||0.281||||||P-value for Fatigue 90 Day Follow-Up|Regression, Linear||||
1759092|NCT00191724|3230630|Superiority or Other|||||||0.985||||||P-value for Emotional 90 Day Follow-Up.|Regression, Linear||||
1759099|NCT00191724|3230631|Superiority or Other|||||||0.528||||||P-value for effect of drotrecogin alfa (activated) dose in right ventricular function at Day 6|Regression, Linear||||
1759100|NCT00191646|3230633|Superiority or Other|||||||0.013|||||||Log Rank||||
1759101|NCT00191646|3230634|Superiority or Other|||||||0.621|||||||Log Rank||||
1759102|NCT00191646|3230635|Superiority or Other|||||||0.784|||||||Fisher Exact||||
1759103|NCT00191646|3230635|Superiority or Other|||||||0.771|||||||Fisher Exact||||
1759104|NCT00191646|3230636|Superiority or Other|||||||0.199|||||||Log Rank|||Using a two-sided log-rank test with a Type I error of 0.05, 636 events for PFS out of the 919 patients would give an 80% statistical power under the alternative hypothesis that the hazard ratio of the G/C arm versus the P/C arm was 0.08.|
1759105|NCT00191477|3230642|Superiority or Other||Hazard Ratio (HR)|0.946||||0.777||95.0|0.643|1.392||Only 87 recurrences and 7 deaths were documented at planned end of follow-up. The study was stopped early for futility reasons based on an interim analysis using pre-defined stopping boundaries for the hazard ratio (HR) of RFS.|Log Rank|||Sample-size calculation based on estimated 1-year recurrence-free survival (RFS) rates of 63% (gemcitabine) and 50% (placebo). 191 critical events were required to detect a difference in RFS (80% power, log-rank test, alpha=0.050). Sample size of 328 patients with clinical evidence of superficial bladder cancer needed to observe these 191 events within a 24-month follow-up period, assuming 246 of these patients would receive instillation and have histopathological diagnosis of pTa/pT1(G1-3/Gx).|
1759106|NCT00191386|3230649|Superiority or Other||||||<|0.001||||||P-Value for 4 Years.|Paired t-test||||
1759107|NCT00191386|3230649|Superiority or Other||||||<|0.001||||||P-Value for 3 Years.|Paired t-test||||
1759108|NCT00191386|3230649|Superiority or Other||||||<|0.001||||||P-Value for 2 Years.|Paired t-test||||
1759109|NCT00191386|3230649|Superiority or Other||||||<|0.001||||||P-Value for 12 Months.|Paired t-test||||
1759110|NCT00191386|3230649|Superiority or Other||||||<|0.001||||||P-Value for 6 Months.|Paired t-test||||
1759111|NCT00191386|3230650|Superiority or Other||||||<|0.001||||||P-Value for Total Score 4 Years.|Paired t-test||||
1759112|NCT00191386|3230650|Superiority or Other||||||<|0.001||||||P-Value for Total Score 3 Years.|Paired t-test||||
1759113|NCT00191386|3230650|Superiority or Other||||||<|0.001||||||P-Value for Total Score 2 Years.|Paired t-test||||
1759114|NCT00191386|3230650|Superiority or Other||||||<|0.001||||||P-Value for Total Score 12 Months|Paired t-test||||
1759115|NCT00191386|3230650|Superiority or Other||||||<|0.001||||||P-Value for Total Score 6 Months|Paired t-test||||
1759116|NCT00191282|3230663|Superiority or Other|||||||0.2617|||||||Chi-squared||||
1759117|NCT00191282|3230665|Superiority or Other|||||||0.2434|||||||Chi-squared||||
1759118|NCT00191282|3230667|Superiority or Other|||||||0.1957|||||||Chi-squared||||
1759119|NCT00191282|3230670|Superiority or Other|||||||0.1424|||||||Chi-squared||||
1759120|NCT00191282|3230672|Superiority or Other|||||||0.086|||||||Chi-squared||||
1759121|NCT00191282|3230674|Superiority or Other|||||||0.7168|||||||Chi-squared||||
1759122|NCT00191282|3230675|Superiority or Other||Hazard Ratio (HR)|0.89||||0.471||95.0|||||Log Rank||||
1759123|NCT00191282|3230676|Superiority or Other||Hazard Ratio (HR)|0.93||||0.863||95.0|||||Log Rank||||
1759124|NCT00191282|3230677|Superiority or Other||Hazard Ratio (HR)|0.9||||0.662||95.0|||||Log Rank||||
1759125|NCT00191282|3230678|Superiority or Other||Hazard Ratio (HR)|1.13||||0.8||95.0|||||Log Rank||||
1759126|NCT00191282|3230679|Superiority or Other||Hazard Ratio (HR)|0.91||||0.525||95.0|||||Log Rank||||
1759127|NCT00191282|3230680|Superiority or Other||Hazard Ratio (HR)|1.09||||0.647||95.0|||||Log Rank||||
1759128|NCT00191282|3230681|Superiority or Other||Hazard Ratio (HR)|1.2||||0.581||95.0|||||Log Rank||||
1759129|NCT00191282|3230682|Superiority or Other||Hazard Ratio (HR)|1.01||||0.948||95.0|||||Log Rank||||
1759130|NCT00191282|3230683|Superiority or Other||Hazard Ratio (HR)|1.05||||0.816||95.0|||||Log Rank||||
1759131|NCT00191282|3230684|Superiority or Other||Hazard Ratio (HR)|1.0||||0.982||95.0|||||Log Rank||||
1759132|NCT00191282|3230685|Superiority or Other||Hazard Ratio (HR)|1.05||||0.706||95.0|||||Log Rank||||
1759133|NCT00191282|3230686|Superiority or Other||Hazard Ratio (HR)|1.01||||0.914||95.0|||||Log Rank||||
1759134|NCT00191282|3230687|Superiority or Other||Hazard Ratio (HR)|0.96||||0.715||95.0|||||Log Rank||||
1759135|NCT00191282|3230688|Superiority or Other||Hazard Ratio (HR)|0.98||||0.866||95.0|||||Log Rank|||To achieve 80% power, 490 pts need to experience primary combined CV outcome to detect diff. between treatments, assuming: >=18.5% reduction in incidence of outcomes, 18 mo. pt recruitment, 18 mo. pt follow-up, 10% annual drop-out rate, 2-yr outcome incidence rate of >=40% (pts in least efficacious treatment), and nominal 2-sided signif. of 0.045.|
1759136|NCT00191165|3230700|Superiority or Other||Mean Difference (Net)|1.13||||0.088||95.0|-0.18|2.44|||ANOVA||Mean Difference = High Dose - Label Dose||
1759137|NCT00191165|3230701|Superiority or Other||Mean Difference (Net)|0.49||||0.061||95.0|-0.02|0.99||P-value for 24-Month Height SDS Change|ANOVA||Mean Difference = High Dose - Label Dose||
1759138|NCT00191165|3230701|Superiority or Other||Mean Difference (Net)|0.16||||0.388||95.0|-0.21|0.53||P-value for 12-Month Height SDS Change|ANOVA||Mean Difference = High Dose - Label Dose||
1759139|NCT00191165|3230702|Superiority or Other||Mean Difference (Net)|0.45||||0.34||95.0|-0.5|1.4|||ANOVA||Mean Difference = High Dose - Label Dose||
1759140|NCT00191152|3230703|Superiority or Other|||||||0.19|||||||Mixed Models Analysis||||
1759141|NCT00191152|3230704|Superiority or Other|||||||0.801|||||||Mixed Models Analysis||||
1759142|NCT00191152|3230705|Superiority or Other|||||||0.117|||||||Mixed Models Analysis||||
1759143|NCT00191152|3230706|Superiority or Other|||||||0.99|||||||Mixed Models Analysis||||
1759144|NCT00191152|3230707|Superiority or Other|||||||0.446|||||||Fisher Exact||||
1759145|NCT00191152|3230708|Superiority or Other|||||||0.364|||||||Fisher Exact||||
1759146|NCT00191152|3230709|Superiority or Other|||||||0.785|||||||Log Rank||||
1759147|NCT00191152|3230710|Superiority or Other|||||||0.446|||||||Log Rank||||
1759160|NCT00191113|3230723|Superiority or Other||Mean Difference (Final Values)|-0.007||||0.945||95.0|-0.199|0.186|||ANOVA||Direction of estimated treatment effect is Humatrope minus Control||
1759161|NCT00191113|3230724|Superiority or Other||||||>|0.999|||||||Fisher Exact||||
1759162|NCT00191113|3230726|Superiority or Other||||||>|0.999|||||||Fisher Exact||||
1759163|NCT00191113|3230728|Superiority or Other|||||||0.545|||||||Fisher Exact||||
1759164|NCT00191113|3230730|Superiority or Other||Mean Difference (Final Values)|-2.492||||0.419||95.0|-8.631|3.646|||ANOVA||Direction of estimated treatment effect is Humatrope minus Control||
1759165|NCT00191113|3230731|Superiority or Other||||||>|0.999|||||||Fisher Exact|||Comparison of proportion of patients with any category of hearing loss between As-Treated Growth Hormone group and As-Treated No Growth Hormone.|
1759166|NCT00191113|3230732|Superiority or Other|||||||0.073|||||||Fisher Exact||||
1759167|NCT00191113|3230733|Superiority or Other|||||||0.744|||||||Fisher Exact||||
1759168|NCT00191113|3230734|Superiority or Other||||||>|0.999|||||||Fisher Exact||||
1759169|NCT00191113|3230735|Superiority or Other||Mean Difference (Net)|6.9|||<|0.001||95.0|5.7|8.1|||ANCOVA||||
1759170|NCT00191113|3230736|Superiority or Other||Mean Difference (Net)|1.1|||<|0.001||95.0|0.9|1.3|||ANCOVA||||
1759171|NCT00191113|3230737|Superiority or Other||Mean Difference (Final Values)|1.0|||<|0.001||95.0|0.9|1.2|||ANCOVA|Model includes baseline height SDS, baseline age, treatment, and interactions. Age and interactions terms removed when not significant.|"Effect direction is As-Treated Growth Hormone minus As-Treated No Growth Hormone"|Estimation analysis of the magnitude of effect of treatment with growth hormone upon Final Height. Null hypothesis is no effect of growth hormone upon attained height standard deviation score (National Center for Health Statistics).|
1759172|NCT00191113|3230738|Superiority or Other||Mean Difference (Final Values)|0.9|||<|0.001||95.0|0.7|1.1|||ANCOVA|Model includes baseline height SDS, baseline age, treatment, and interactions. Age and interaction terms removed when not significant.|"Effect direction is As-Randomized Humatrope minus As-Randomized Control"|This component of the primary analysis is inferential i.e. to ascertain definitively whether Humatrope treatment affects change in Height SDS (NCHS). Null hypothesis is no effect of Humatrope treatment.|
1759173|NCT00191100|3230739|Superiority or Other|||||||0.0227|||||||Log Rank||||
1759174|NCT00191100|3230740|Superiority or Other|||||||0.0224|||||||Log Rank||||
1759175|NCT00191100|3230741|Superiority or Other|||||||0.25||||||The p-value is two-sided and was tested at the 0.05 significance level.|Fisher Exact||||
1759176|NCT00191100|3230742|Superiority or Other|||||||0.096||||||The p-value is two-sided and was tested at the 0.05 significance level.|Fisher Exact|||"Note: There were 2 patients with unknown site of progressive disease; these patients were counted as a Local failure.~Note: There was 1 patient with both local and distant failure; this patient was counted as a Local failure."|
1759177|NCT00191100|3230743|Superiority or Other|||||||0.0008|||||||Log Rank||||
1759178|NCT00191100|3230744|Superiority or Other||PFS Probability Difference at 3 Years|0.095||||0.029||95.0|0.01|0.179||The p-value is two-sided and was tested at the 0.05 significance level.|Z Statistic||Difference in progression-free survival probability between Gem/Cis/Rad and Cis/Rad. The difference in PFS probability between the two treatment arms can also be presented as a percentage (ie, PFS at 3 years was 9.5% better in the Gem/Cis/Rad arm).||
1759179|NCT00190775|3230749|Superiority or Other|||||||0.986||||||P-Vaue for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759180|NCT00190775|3230749|Superiority or Other|||||||0.569||||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759181|NCT00190775|3230749|Superiority or Other|||||||0.53||||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759182|NCT00190775|3230749|Superiority or Other|||||||0.546||||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759183|NCT00190775|3230750|Superiority or Other|||||||0.005||||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759184|NCT00190775|3230750|Superiority or Other|||||||0.004||||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759185|NCT00190775|3230750|Superiority or Other|||||||0.938||||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759186|NCT00190775|3230750|Superiority or Other|||||||0.034||||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759187|NCT00190775|3230750|Superiority or Other|||||||0.071||||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759188|NCT00190775|3230750|Superiority or Other|||||||0.716||||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759189|NCT00190775|3230750|Superiority or Other|||||||0.002||||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759190|NCT00190775|3230750|Superiority or Other|||||||0.004||||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759191|NCT00190775|3230750|Superiority or Other|||||||0.779||||||P-Value for Hyper/Impulsive Scale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759192|NCT00190775|3230750|Superiority or Other|||||||0.005||||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759193|NCT00190775|3230750|Superiority or Other|||||||0.011||||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759194|NCT00190775|3230750|Superiority or Other|||||||0.722||||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759673|NCT00182325|3231202|Superiority|||||||0.12|||||||t-test, 2 sided||||
1759195|NCT00190775|3230751|Superiority or Other|||||||0.005||||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759196|NCT00190775|3230751|Superiority or Other||||||<|0.001||||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759197|NCT00190775|3230751|Superiority or Other||||||<|0.71||||||P-Value for ADHD Index Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759198|NCT00190775|3230751|Superiority or Other||||||<|0.021||||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759199|NCT00190775|3230751|Superiority or Other||||||<|0.001||||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759200|NCT00190775|3230751|Superiority or Other||||||<|0.457||||||P-Value for Inattention Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759201|NCT00190775|3230751|Superiority or Other||||||<|0.012||||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759202|NCT00190775|3230751|Superiority or Other||||||<|0.054||||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759203|NCT00190775|3230751|Superiority or Other||||||<|0.533||||||P-Value for Hyper/Impulsive Subscale.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759204|NCT00190775|3230751|Superiority or Other||||||<|0.007||||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759205|NCT00190775|3230751|Superiority or Other||||||<|0.003||||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759206|NCT00190775|3230751|Superiority or Other||||||<|0.892||||||P-Value for Total ADHD Symptoms Score.|ANCOVA|Model included visit by therapy, pooled investigator, child with ADHD, and baseline.|||
1759207|NCT00190775|3230752|Superiority or Other|||||||0.171||||||P-Value is for Trait Anxiety Score at 24 weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759208|NCT00190775|3230752|Superiority or Other|||||||0.897||||||P-Value is for State Anxiety Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759209|NCT00190775|3230752|Superiority or Other|||||||0.026||||||P-Value for Trait Anxiety Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759210|NCT00190775|3230752|Superiority or Other|||||||0.108||||||P-Value for State Anxiety Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759211|NCT00190775|3230753|Superiority or Other|||||||0.797||||||P-Value for 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759212|NCT00190775|3230753|Superiority or Other|||||||0.553||||||P-Value for 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759213|NCT00190775|3230754|Superiority or Other||||||<|0.001||||||P-Value for 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759214|NCT00190775|3230754|Superiority or Other||||||<|0.001||||||P-Value for 8 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759215|NCT00190775|3230755|Superiority or Other||||||<|0.001||||||P-Value for Inattention Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759216|NCT00190775|3230755|Superiority or Other||||||<|0.001||||||P-Value for Hyperactivity Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759217|NCT00190775|3230755|Superiority or Other||||||<|0.001||||||P-Value for Total Score at 24 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759218|NCT00190775|3230755|Superiority or Other||||||<|0.001||||||P-Value for Inattention Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759219|NCT00190775|3230755|Superiority or Other||||||<|0.004||||||P-Value for Hyperactivity Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759220|NCT00190775|3230755|Superiority or Other||||||<|0.001||||||P-Value for Total Score at 12 Weeks.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759221|NCT00190775|3230756|Superiority or Other|||||||0.462||||||P-Value for Efficacy Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759222|NCT00190775|3230756|Superiority or Other|||||||0.62||||||P-Value for Satisfaction Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759223|NCT00190775|3230756|Superiority or Other|||||||0.365||||||P-Value for PSOC Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759224|NCT00190775|3230757|Superiority or Other|||||||0.399||||||P-Value for Efficacy Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759225|NCT00190775|3230757|Superiority or Other|||||||0.569||||||P-Value for Satisfaction Scale.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759226|NCT00190775|3230757|Superiority or Other|||||||0.875||||||P-Value for PSOC Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759227|NCT00190775|3230758|Superiority or Other|||||||0.675||||||P-Value for Conduct Disorder Flag.|Fisher Exact||||
1759228|NCT00190775|3230758|Superiority or Other|||||||0.792||||||P-Value for Oppositional Defiant Disorder Flag|Fisher Exact||||
1759229|NCT00190775|3230759|Superiority or Other|||||||0.333||||||P-Value for Inattention Symptom ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759230|NCT00190775|3230759|Superiority or Other|||||||0.997||||||P-Value for Hyperactive-Impulsive Symptom ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759231|NCT00190775|3230759|Superiority or Other|||||||0.583||||||P-Value for Total ADHD Score.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759232|NCT00190775|3230760|Superiority or Other|||||||0.636||||||P-Value for Child Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759233|NCT00190775|3230760|Superiority or Other|||||||0.918||||||P-Value for Child Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759234|NCT00190775|3230760|Superiority or Other|||||||0.772||||||P-Value for Child Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759235|NCT00190775|3230760|Superiority or Other|||||||0.575||||||P-Value for Child Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759236|NCT00190775|3230760|Superiority or Other|||||||0.3||||||P-Value for Child Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759237|NCT00190775|3230760|Superiority or Other|||||||0.401||||||P-Value for Child Involvement Father.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759238|NCT00190775|3230760|Superiority or Other|||||||0.828||||||P-Value for Child Involvement Mother.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759239|NCT00190775|3230761|Superiority or Other|||||||0.827||||||P-Value for Child Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759240|NCT00190775|3230761|Superiority or Other|||||||0.807||||||P-Value for Child Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759241|NCT00190775|3230761|Superiority or Other|||||||0.961||||||P-Value for Child Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759242|NCT00190775|3230761|Superiority or Other|||||||0.914||||||P-Value for Child Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759243|NCT00190775|3230761|Superiority or Other|||||||0.318||||||P-Value for Child Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759244|NCT00190775|3230761|Superiority or Other|||||||0.792||||||P-Value for Child Involvement Father.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759245|NCT00190775|3230761|Superiority or Other|||||||0.895||||||P-Value for Child Involvement Mother.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759246|NCT00190775|3230762|Superiority or Other|||||||0.875||||||P-Value for Positive Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759247|NCT00190775|3230762|Superiority or Other|||||||0.166||||||P-Value for Negative Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759248|NCT00190775|3230762|Superiority or Other|||||||0.444||||||P-Value for Dysfunctional Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759249|NCT00190775|3230762|Superiority or Other|||||||0.925||||||P-Value Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759250|NCT00190775|3230762|Superiority or Other|||||||0.12||||||P-Value for Parent Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759251|NCT00190775|3230762|Superiority or Other|||||||0.072||||||P-Value for Parent Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759252|NCT00190775|3230762|Superiority or Other|||||||0.884||||||P-Value for Parent Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759253|NCT00190775|3230762|Superiority or Other|||||||0.864||||||P-Value for Parent Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759254|NCT00190775|3230762|Superiority or Other|||||||0.784||||||P-Value for Parent Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759255|NCT00190775|3230763|Superiority or Other|||||||0.283||||||P-Value for Positive Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759256|NCT00190775|3230763|Superiority or Other|||||||0.498||||||P-Value for Negative Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759257|NCT00190775|3230763|Superiority or Other|||||||0.808||||||P-Value for Dysfunctional Parenting Composite.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759258|NCT00190775|3230763|Superiority or Other|||||||0.881||||||P-Value for Parent Other Discipline Practice.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759259|NCT00190775|3230763|Superiority or Other|||||||0.673||||||P-Value for Parent Corporal Punishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759260|NCT00190775|3230763|Superiority or Other|||||||0.205||||||P-Value for Parent Inconsistent Discipline.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759261|NCT00190775|3230763|Superiority or Other|||||||0.927||||||P-Value for Parent Poor Supervision.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759262|NCT00190775|3230763|Superiority or Other|||||||0.249||||||P-Value for Parent Positive Parenting.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759263|NCT00190775|3230763|Superiority or Other|||||||0.42||||||P-Value for Parent Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759264|NCT00190775|3230764|Superiority or Other|||||||0.906||||||P-Value for Child Domain Acceptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759265|NCT00190775|3230764|Superiority or Other|||||||0.381||||||P-Value for Child Domain Mood.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759266|NCT00190775|3230764|Superiority or Other|||||||0.167||||||P-Value for Child Domain Demandingness.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759267|NCT00190775|3230764|Superiority or Other|||||||0.439||||||P-Value for Child Domain Reinforces Parent.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759268|NCT00190775|3230764|Superiority or Other|||||||0.883||||||P-Value for Child Domain Adaptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759269|NCT00190775|3230764|Superiority or Other|||||||0.518||||||P-Value for Child Domain Distractibility/Hyperactive.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759270|NCT00190775|3230764|Superiority or Other|||||||0.081||||||P-Value for Defensive Responding.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759271|NCT00190775|3230764|Superiority or Other|||||||0.785||||||P-Value for Child Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759272|NCT00190775|3230765|Superiority or Other|||||||0.84||||||P-Value for Parent Domain Spouse.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759273|NCT00190775|3230765|Superiority or Other|||||||0.05||||||P-Value for Parent Domain Depression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759274|NCT00190775|3230765|Superiority or Other|||||||0.848||||||P-Value for Parent Domain Role Restriction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759275|NCT00190775|3230765|Superiority or Other|||||||0.949||||||P-Value for Parent Domain Health.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759276|NCT00190775|3230765|Superiority or Other|||||||0.472||||||P-Value for Parent Domain Attachment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759277|NCT00190775|3230765|Superiority or Other|||||||0.161||||||P-Value for Parent Domain Isolation.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759278|NCT00190775|3230765|Superiority or Other|||||||0.182||||||P-Value for Parent Domain Competence.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759279|NCT00190775|3230765|Superiority or Other|||||||0.103||||||P-Value for Parent Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759280|NCT00190775|3230766|Superiority or Other|||||||0.34||||||P-Value for Life Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759281|NCT00190775|3230766|Superiority or Other|||||||0.28||||||P-Value for Total Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759282|NCT00190775|3230767|Superiority or Other|||||||0.671||||||P-Value for Child Domain Acceptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759283|NCT00190775|3230767|Superiority or Other|||||||0.854||||||P-Value for Child Domain Mood.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759284|NCT00190775|3230767|Superiority or Other|||||||0.075||||||P-Value for Child Domain Demandingness.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759285|NCT00190775|3230767|Superiority or Other|||||||0.963||||||P-Value for Child Domain Reinforces Parent.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759286|NCT00190775|3230767|Superiority or Other|||||||0.383||||||P-Value for Child Domain Adaptability.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759287|NCT00190775|3230767|Superiority or Other|||||||0.567||||||P-Value for Child Domain Distractibility/Hyperactive.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759288|NCT00190775|3230767|Superiority or Other|||||||0.062||||||P-Value for Defensive Responding.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759289|NCT00190775|3230767|Superiority or Other|||||||0.578||||||P-Value for Child Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759290|NCT00190775|3230768|Superiority or Other|||||||0.434||||||P-Value for Parent Domain Spouse.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759291|NCT00190775|3230768|Superiority or Other|||||||0.03||||||P-Value for Parent Domain Depression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759292|NCT00190775|3230768|Superiority or Other|||||||0.176||||||P-Value for Parent Domain Role Restriction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759293|NCT00190775|3230768|Superiority or Other|||||||0.376||||||P-Value for Parent Domain Health.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759294|NCT00190775|3230768|Superiority or Other|||||||0.677||||||P-Value for Parent Domain Attachment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759295|NCT00190775|3230768|Superiority or Other|||||||0.435||||||P-Value for Parent Domain Isolation.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759296|NCT00190775|3230768|Superiority or Other|||||||0.459||||||P-Value for Parent Domain Competence.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759297|NCT00190775|3230768|Superiority or Other|||||||0.056||||||P-Value for Parent Domain Total.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759298|NCT00190775|3230769|Superiority or Other|||||||0.134||||||P-Value for Life Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759299|NCT00190775|3230769|Superiority or Other|||||||0.446||||||P-Value for Total Stress.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759300|NCT00190775|3230770|Superiority or Other||Mean Difference (Final Values)|-4.28|Standard Error of the Mean|1.05||0.001||95.0|||||Mixed Models Analysis|Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.|Least Squares Mean Difference = Atomoxetine - Placebo.|Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.|
1759301|NCT00190775|3230771|Superiority or Other|||||||0.543||||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759302|NCT00190775|3230771|Superiority or Other|||||||0.214||||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759303|NCT00190775|3230771|Superiority or Other|||||||0.947||||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759304|NCT00190775|3230771|Superiority or Other|||||||0.163||||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759305|NCT00190775|3230771|Superiority or Other|||||||0.248||||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759306|NCT00190775|3230772|Superiority or Other|||||||0.788||||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759307|NCT00190775|3230772|Superiority or Other|||||||0.955||||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759308|NCT00190775|3230772|Superiority or Other|||||||0.795||||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759309|NCT00190775|3230772|Superiority or Other|||||||0.087||||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759310|NCT00190775|3230772|Superiority or Other|||||||0.334||||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759311|NCT00190775|3230773|Superiority or Other|||||||0.918||||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759312|NCT00190775|3230773|Superiority or Other|||||||0.059||||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759313|NCT00190775|3230773|Superiority or Other|||||||0.547||||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759314|NCT00190775|3230773|Superiority or Other|||||||0.494||||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759315|NCT00190775|3230773|Superiority or Other|||||||0.544||||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759316|NCT00190775|3230774|Superiority or Other|||||||0.405||||||P-Value for Dyadic Cohesion.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759317|NCT00190775|3230774|Superiority or Other|||||||0.018||||||P-Value for Affectional Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759318|NCT00190775|3230774|Superiority or Other|||||||0.67||||||P-Value for Dyadic Satisfaction.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759319|NCT00190775|3230774|Superiority or Other|||||||0.789||||||P-Value for Dyadic Consensus.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759320|NCT00190775|3230774|Superiority or Other|||||||0.617||||||P-Value for Total Dyadic Adjustment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759321|NCT00190775|3230775|Superiority or Other|||||||0.446||||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759322|NCT00190775|3230775|Superiority or Other|||||||0.36||||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759323|NCT00190775|3230775|Superiority or Other|||||||0.774||||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759324|NCT00190775|3230775|Superiority or Other|||||||0.685||||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759325|NCT00190775|3230775|Superiority or Other|||||||0.391||||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759326|NCT00190775|3230775|Superiority or Other|||||||0.788||||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759327|NCT00190775|3230775|Superiority or Other|||||||0.941||||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759328|NCT00190775|3230776|Superiority or Other|||||||0.403||||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759329|NCT00190775|3230776|Superiority or Other|||||||0.807||||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759330|NCT00190775|3230776|Superiority or Other|||||||0.903||||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759331|NCT00190775|3230776|Superiority or Other|||||||0.618||||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759332|NCT00190775|3230776|Superiority or Other|||||||0.686||||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759333|NCT00190775|3230776|Superiority or Other|||||||0.705||||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759334|NCT00190775|3230776|Superiority or Other|||||||0.575||||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759335|NCT00190775|3230777|Superiority or Other|||||||0.446||||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759336|NCT00190775|3230777|Superiority or Other|||||||0.36||||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759337|NCT00190775|3230777|Superiority or Other|||||||0.19||||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759338|NCT00190775|3230777|Superiority or Other|||||||0.788||||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759339|NCT00190775|3230777|Superiority or Other|||||||0.931||||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759340|NCT00190775|3230777|Superiority or Other|||||||0.122||||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759341|NCT00190775|3230777|Superiority or Other|||||||0.176||||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759342|NCT00190775|3230778|Superiority or Other|||||||0.315||||||P-Value for Values and Norms.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759343|NCT00190775|3230778|Superiority or Other|||||||0.515||||||P-Value for Control.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759344|NCT00190775|3230778|Superiority or Other|||||||0.514||||||P-Value for Involvement.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759345|NCT00190775|3230778|Superiority or Other|||||||0.052||||||P-Value for Affective Expression.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759346|NCT00190775|3230778|Superiority or Other|||||||0.6||||||P-Value for Communication.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759347|NCT00190775|3230778|Superiority or Other|||||||0.491||||||P-Value for Role Performance.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759348|NCT00190775|3230778|Superiority or Other|||||||0.905||||||P-Value for Task Accomplishment.|ANCOVA|Model included treatment, pooled investigator, child with ADHD, and baseline.|||
1759349|NCT00190775|3230779|Superiority or Other||Mean Difference (Final Values)|-7.78|Standard Error of the Mean|1.11|<|0.001||95.0|||||Mixed Models Analysis|Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.|Least Squares Mean Difference = Atomoxetine - Placebo.|Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.|
1759350|NCT00190749|3230780|Superiority or Other|||||||0.221|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||VLDL mean particle size|
1759351|NCT00190749|3230780|Superiority or Other|||||||0.047|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||VLDL mean particle size|
1759352|NCT00190749|3230780|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||VLDL mean particle size|
1759353|NCT00190749|3230780|Superiority or Other||||||<|0.033||||||Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|ANCOVA|||Very small LDL|
1759354|NCT00190749|3230780|Superiority or Other||||||<|0.246|||||||t-test, 2 sided|Withn group p-values are from t-tests on LSMean change||Very small LDL|
1759355|NCT00190749|3230780|Superiority or Other||||||<|0.176|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Very small LDL|
1759356|NCT00190749|3230780|Superiority or Other||||||<|0.024|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Small LDL|
1759357|NCT00190749|3230780|Superiority or Other||||||<|0.304|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Small LDL|
1759358|NCT00190749|3230780|Superiority or Other||||||<|0.099|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Small LDL|
1759359|NCT00190749|3230780|Superiority or Other||||||<|0.12|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Medium small LDL|
1759360|NCT00190749|3230780|Superiority or Other||||||<|0.662|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Medium small LDL|
1759361|NCT00190749|3230780|Superiority or Other||||||<|0.009|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Medium small LDL|
1759362|NCT00190749|3230780|Superiority or Other||||||<|0.049|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||IDL|
1759363|NCT00190749|3230780|Superiority or Other||||||<|0.928|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||IDL|
1759364|NCT00190749|3230780|Superiority or Other||||||<|0.013|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||IDL|
1759365|NCT00190749|3230780|Superiority or Other||||||<|0.038||||||Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline TReatment Pooled Investigator|ANCOVA|||HDL particles, total|
1759366|NCT00190749|3230780|Superiority or Other||||||<|0.959|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||HDL particles, total|
1759367|NCT00190749|3230780|Superiority or Other||||||<|0.009|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||HDL particles, total|
1759368|NCT00190749|3230781|Superiority or Other|||||||0.024|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|||
1759369|NCT00190749|3230781|Superiority or Other|||||||0.545|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759370|NCT00190749|3230781|Superiority or Other|||||||0.027|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759371|NCT00190749|3230782|Superiority or Other|||||||0.996|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|||
1759372|NCT00190749|3230782|Superiority or Other|||||||0.237|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759373|NCT00190749|3230782|Superiority or Other|||||||0.176|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759374|NCT00190749|3230783|Superiority or Other|||||||0.997|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|||
1759375|NCT00190749|3230783|Superiority or Other|||||||0.76|||||||t-test, 2 sided|Within group p-values are frm t-tests on LSMean change|||
1759376|NCT00190749|3230783|Superiority or Other|||||||0.74|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759377|NCT00190749|3230784|Superiority or Other|||||||0.352|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|||
1759378|NCT00190749|3230784|Superiority or Other|||||||0.829|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759379|NCT00190749|3230784|Superiority or Other|||||||0.156|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759380|NCT00190749|3230785|Superiority or Other|||||||0.806|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 9|
1759381|NCT00190749|3230785|Superiority or Other|||||||0.112|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 9|
1759382|NCT00190749|3230785|Superiority or Other|||||||0.036|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 9|
1759383|NCT00190749|3230785|Superiority or Other|||||||0.629|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 8|
1759384|NCT00190749|3230785|Superiority or Other|||||||0.071|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 8|
1759385|NCT00190749|3230785|Superiority or Other|||||||0.151|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 8|
1759386|NCT00190749|3230785|Superiority or Other|||||||0.827|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 7|
1759387|NCT00190749|3230785|Superiority or Other|||||||0.214|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 7|
1759388|NCT00190749|3230785|Superiority or Other|||||||0.097|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 7|
1759389|NCT00190749|3230785|Superiority or Other|||||||0.799|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 6|
1759390|NCT00190749|3230785|Superiority or Other|||||||0.186|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 6|
1759391|NCT00190749|3230785|Superiority or Other|||||||0.242|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 6|
1759392|NCT00190749|3230785|Superiority or Other|||||||0.532|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 5|
1759393|NCT00190749|3230785|Superiority or Other|||||||0.235|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 5|
1759394|NCT00190749|3230785|Superiority or Other|||||||0.034|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 5|
1759395|NCT00190749|3230785|Superiority or Other|||||||0.733|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 4|
1759396|NCT00190749|3230785|Superiority or Other|||||||0.019|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||ITem 4|
1759397|NCT00190749|3230785|Superiority or Other|||||||0.002|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 4|
1759398|NCT00190749|3230785|Superiority or Other|||||||0.699|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 3|
1759399|NCT00190749|3230785|Superiority or Other|||||||0.027|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 3|
1759400|NCT00190749|3230785|Superiority or Other|||||||0.045|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 3|
1759401|NCT00190749|3230785|Superiority or Other|||||||0.793|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 2|
1759402|NCT00190749|3230785|Superiority or Other|||||||0.009|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 2|
1759403|NCT00190749|3230785|Superiority or Other|||||||0.011|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 2|
1759404|NCT00190749|3230785|Superiority or Other|||||||0.549|||||||ANCOVA|Overall p-values are from Type 3 sums of squares, ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Item 1|
1759405|NCT00190749|3230785|Superiority or Other|||||||0.001|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 1|
1759406|NCT00190749|3230785|Superiority or Other|||||||0.004|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Item 1|
1759407|NCT00190749|3230786|Superiority or Other|||||||0.479|||||||ANCOVA|Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|||
1759408|NCT00190749|3230786|Superiority or Other|||||||0.922|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759409|NCT00190749|3230786|Superiority or Other|||||||0.302|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759410|NCT00190749|3230787|Superiority or Other|||||||0.591|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|||
1759411|NCT00190749|3230787|Superiority or Other|||||||0.853|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759412|NCT00190749|3230787|Superiority or Other|||||||0.623|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759413|NCT00190749|3230788|Superiority or Other|||||||0.832|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|||
1759414|NCT00190749|3230788|Superiority or Other|||||||0.763|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759415|NCT00190749|3230788|Superiority or Other|||||||0.943|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759416|NCT00190749|3230789|Superiority or Other|||||||0.76|||||||ANCOVA|Overall p-values are from Type 3 sums of square ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|||
1759417|NCT00190749|3230789|Superiority or Other|||||||0.01|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759418|NCT00190749|3230789|Superiority or Other|||||||0.012||||||Within group p-values are from t-tests on LSMean change|t-test, 2 sided||||
1759419|NCT00190749|3230790|Superiority or Other|||||||0.475|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Anxiety-Depression subscale|
1759420|NCT00190749|3230790|Superiority or Other|||||||0.612|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Anxiety-Depression subscale|
1759421|NCT00190749|3230790|Superiority or Other|||||||0.15|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Anxiety-Depression subscale|
1759422|NCT00190749|3230790|Superiority or Other|||||||0.559|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator||Negative subscale|
1759423|NCT00190749|3230790|Superiority or Other|||||||0.846|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Negative subscale|
1759424|NCT00190749|3230790|Superiority or Other|||||||0.365|||||||t-test, 2 sided|With group p-values are from t-tests on LSMean change||Negative subscale|
1759425|NCT00190749|3230790|Superiority or Other|||||||0.467|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||Positive subscale|
1759426|NCT00190749|3230790|Superiority or Other|||||||0.002|||||||t-test, 2 sided|With group p-values are from t-tests on LSMean||Positive subscale|
1759427|NCT00190749|3230790|Superiority or Other|||||||0.012|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change||Positive Subscale|
1759428|NCT00190749|3230790|Superiority or Other|||||||0.951|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator||Total Score|
1759429|NCT00190749|3230790|Superiority or Other|||||||0.159|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean changes||Total Score|
1759430|NCT00190749|3230790|Superiority or Other|||||||0.111|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean||Total Score|
1759431|NCT00190749|3230791|Superiority or Other|||||||0.689|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator|||
1759432|NCT00190749|3230791|Superiority or Other|||||||0.712|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759433|NCT00190749|3230791|Superiority or Other|||||||0.456|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759434|NCT00190749|3230792|Superiority or Other|||||||0.076|||||||ANCOVA|Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator|||
1759435|NCT00190749|3230792|Superiority or Other|||||||0.011|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759436|NCT00190749|3230792|Superiority or Other|||||||0.406|||||||t-test, 2 sided|With group p-values are from t-tests on LSMean change|||
1759437|NCT00190749|3230793|Superiority or Other|||||||0.609|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator|||
1759438|NCT00190749|3230793|Superiority or Other|||||||0.105|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change.|||
1759439|NCT00190749|3230793|Superiority or Other|||||||0.274|||||||t-test, 2 sided|Within group p-vales are from t-tests on LSMean change|||
1759440|NCT00190749|3230794|Superiority or Other|||||||0.239|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator|||
1759441|NCT00190749|3230794|Superiority or Other|||||||0.266|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759442|NCT00190749|3230794|Superiority or Other|||||||0.007|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759443|NCT00190749|3230795|Superiority or Other|||||||0.076|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator|||
1759444|NCT00190749|3230795|Superiority or Other|||||||0.013|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759445|NCT00190749|3230795|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|With group p-values are from t-tests on LSMean change|||
1759446|NCT00190749|3230796|Superiority or Other|||||||0.065|||||||ANCOVA|Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator|||
1759447|NCT00190749|3230796|Superiority or Other|||||||0.019|||||||t-test, 2 sided|Within group p-values are from t-tests on LSMean change|||
1759448|NCT00190749|3230796|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|Within group p-values are from t-tests on Least Squares Mean (LSMean) change|||
1759449|NCT00190749|3230797|Superiority or Other|||||||0.043|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 9|
1759450|NCT00190749|3230797|Superiority or Other|||||||0.642|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 9|
1759451|NCT00190749|3230797|Superiority or Other|||||||0.359|||||||Pearson's correlation coefficient|||Change in Eating Bahavior Item 8|
1759452|NCT00190749|3230797|Superiority or Other|||||||0.844|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 8|
1759453|NCT00190749|3230797|Superiority or Other|||||||0.805|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 7|
1759454|NCT00190749|3230797|Superiority or Other|||||||0.281|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 7|
1759455|NCT00190749|3230797|Superiority or Other|||||||0.711|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 6|
1759456|NCT00190749|3230797|Superiority or Other|||||||0.404|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 6|
1759457|NCT00190749|3230797|Superiority or Other|||||||0.739|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 5|
1759458|NCT00190749|3230797|Superiority or Other|||||||0.468|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 5|
1759459|NCT00190749|3230797|Superiority or Other|||||||0.306|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 4|
1759460|NCT00190749|3230797|Superiority or Other|||||||0.675|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 4|
1759461|NCT00190749|3230797|Superiority or Other|||||||0.846|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 3|
1759462|NCT00190749|3230797|Superiority or Other|||||||0.956|||||||Pearson's correlation coefficient|||Change in Eating Bahavior Item 3|
1759463|NCT00190749|3230797|Superiority or Other|||||||0.129|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 2|
1759464|NCT00190749|3230797|Superiority or Other|||||||0.392|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 2|
1759465|NCT00190749|3230797|Superiority or Other|||||||0.033|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 1|
1759466|NCT00190749|3230797|Superiority or Other|||||||0.393|||||||Pearson's correlation coefficient|||Change in Eating Behavior Item 1|
1759467|NCT00190749|3230798|Superiority or Other|||||||0.675|||||||Pearson's correlation coefficient||||
1759468|NCT00190749|3230798|Superiority or Other|||||||0.815|||||||Pearson's correlation coefficient||||
1759469|NCT00190749|3230799|Superiority or Other|||||||0.777|||||||Pearson's correlation coefficient||||
1759470|NCT00190749|3230799|Superiority or Other|||||||0.793|||||||Pearson's correlation coefficient||||
1759471|NCT00190749|3230800|Superiority or Other|||||||0.168|||||||Pearson's correlation coefficient||||
1759472|NCT00190749|3230800|Superiority or Other|||||||0.201|||||||Pearson's correlation coefficient||||
1759473|NCT00190749|3230801|Superiority or Other|||||||0.163|||||||Pearson's correlation coefficient||||
1759474|NCT00190749|3230801|Superiority or Other|||||||0.249|||||||Pearson's correlation coefficient||||
1759475|NCT00190749|3230802|Superiority or Other|||||||0.974|||||||Pearson's correlation coefficient||||
1759476|NCT00190749|3230802|Superiority or Other|||||||0.454|||||||Pearson's correlation coefficient||||
1759477|NCT00190749|3230803|Superiority or Other|||||||0.456|||||||Pearson's correlation coefficient||||
1759478|NCT00190749|3230803|Superiority or Other|||||||0.994|||||||Pearson's correlation coefficient||||
1759479|NCT00190749|3230804|Superiority or Other|||||||0.191|||||||Pearson's correlation coefficient||||
1759480|NCT00190749|3230804|Superiority or Other|||||||0.672|||||||Pearson's correlation coefficient||||
1759481|NCT00190749|3230805|Superiority or Other|||||||0.714|||||||Pearson's correlation coefficient||||
1759482|NCT00190749|3230805|Superiority or Other|||||||0.829|||||||Pearson's correlation coefficient||||
1759483|NCT00190749|3230806|Superiority or Other|||||||0.622|||||||Pearson's correlation coefficient||||
1759484|NCT00190749|3230806|Superiority or Other|||||||0.766|||||||Pearson's correlation coefficient||||
1759485|NCT00190749|3230807|Superiority or Other|||||||0.277|||||||Pearson's correlation coefficient||||
1759486|NCT00190749|3230807|Superiority or Other|||||||0.256|||||||Pearson's correlation coefficient||||
1759487|NCT00190749|3230808|Superiority or Other|||||||0.295|||||||Pearson's correlation coefficient||||
1759488|NCT00190749|3230808|Superiority or Other|||||||0.184|||||||Pearson's correlation coefficient||||
1759489|NCT00190749|3230809|Superiority or Other|||||||0.204||||||P-value for change to last observation.|ANCOVA||||
1759490|NCT00190749|3230809|Superiority or Other|||||||0.03||||||P-value is change to last observation|t-test, 2 sided||||
1759491|NCT00190749|3230809|Superiority or Other|||||||0.226||||||P-value for change to last observation|t-test, 2 sided||||
1759492|NCT00190684|3230814|Superiority or Other||||||<|0.001||||||p-value is for CPRS Oppositional Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759493|NCT00190684|3230814|Superiority or Other||||||<|0.026||||||p-value is for CPRS Hyperactive Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759494|NCT00190684|3230814|Superiority or Other||||||p<|0||||||p-value is for CPRS Cognitive Subscale|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759495|NCT00190684|3230814|Superiority or Other||||||<|0.001||||||p-value is for CPRS ADHD Index Subscale within group|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759496|NCT00190684|3230815|Superiority or Other||||||<|0.001||||||p-value is for CGI ADHD Severity within group|Wilcoxon signed-rank test|This test is for a significance of a location shift from zero of the change from baseline within a treatment group.|||
1759497|NCT00190684|3230816|Superiority or Other||||||p<|0||||||p-value is for Hyperactive Subscale Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759498|NCT00190684|3230816|Superiority or Other||||||<|0.001||||||p-value is for Inattentive Subscale Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759499|NCT00190684|3230816|Superiority or Other||||||p<|0||||||p-value is for Total Score|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759500|NCT00190684|3230818|Superiority or Other||||||<|0.001||||||p-value is for HR.|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759501|NCT00190684|3230819|Superiority or Other|||||||0.632||||||p-value is for QT Fridericia Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759502|NCT00190684|3230819|Superiority or Other|||||||0.31||||||p-value is for QT Data Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759674|NCT00182325|3231203|Superiority|||||||0.26|||||||t-test, 2 sided||||
1759503|NCT00190684|3230819|Superiority or Other||||||<|0.001||||||p-value is for QT Bazett Correction|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759504|NCT00190684|3230819|Superiority or Other||||||<|0.001||||||p-value is for QRS Interval|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759505|NCT00190684|3230819|Superiority or Other||||||<|0.001||||||p-value is for RR interval|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759506|NCT00190684|3230820|Superiority or Other||||||<|0.001||||||p-value is for BMI 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759507|NCT00190684|3230820|Superiority or Other||||||<|0.351||||||p-value is for BMI 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759508|NCT00190684|3230820|Superiority or Other||||||<|0.032||||||p-value is for BMI 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759509|NCT00190684|3230820|Superiority or Other||||||<|0.001||||||p-value is for BMI 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759510|NCT00190684|3230820|Superiority or Other||||||<|0.001||||||p-value is for height 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759511|NCT00190684|3230820|Superiority or Other||||||<|0.044||||||p-value is for height 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759512|NCT00190684|3230820|Superiority or Other||||||<|0.001||||||p-value is for height 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759513|NCT00190684|3230820|Superiority or Other||||||<|0.001||||||p-value is for height 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759514|NCT00190684|3230820|Superiority or Other||||||<|0.001||||||p-value is for weight 75th to 100th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759515|NCT00190684|3230820|Superiority or Other||||||<|0.644||||||p-value is for weight 50th to 75th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759516|NCT00190684|3230820|Superiority or Other||||||<|0.001||||||p-value is for weight 25th to 50th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759517|NCT00190684|3230820|Superiority or Other||||||<|0.001||||||p-value is for weight 0 to 25th percentile|paired t-test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759518|NCT00190684|3230821|Superiority or Other||||||<|0.001||||||p-value is for height|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759519|NCT00190684|3230822|Superiority or Other||||||<|0.001||||||p-value is for weight|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759520|NCT00190684|3230823|Superiority or Other||||||<|0.001||||||p-value is for pulse|Wilcoxon signed-rank test|||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759521|NCT00190684|3230824|Superiority or Other||||||<|0.001||||||p-value is for diastolic BP|Wilcoxon sign-rank test|Change = endpoint-baseline||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759522|NCT00190684|3230824|Superiority or Other||||||<|0.001||||||p-value is for systolic BP|Wilcoxon signed-rank test|Change = endpoint-baseline||Tested was the null hypothesis that there would be no statistically significant difference between baseline and endpoint.|
1759523|NCT00189540|3230834|Superiority or Other|||||||0.05|||||||ANCOVA|||Comparison between groups for mean TBI at Month 6 versus baseline.|
1759524|NCT00189540|3230834|Superiority or Other|||||||0.06|||||||ANCOVA|||Comparison between groups for mean TBI at Month 3 versus baseline.|
1759525|NCT00189540|3230835|Superiority or Other|||||||0.45|||||||ANCOVA|||Comparison at Month 6|
1759526|NCT00189540|3230835|Superiority or Other|||||||0.77|||||||ANCOVA|||Comparison at Month 3|
1759527|NCT00189540|3230836|Superiority or Other|||||||1|||||||Fisher Exact||||
1759528|NCT00189540|3230837|Superiority or Other|||||||0.04|||||||ANCOVA|||Comparison between groups at Month 6|
1759529|NCT00189540|3230837|Superiority or Other|||||||0.2|||||||ANCOVA|||Comparison between groups at Month 3|
1759530|NCT00189540|3230838|Superiority or Other|||||||0.28|||||||Fisher Exact|||The comparison of groups at Month 6.|
1759531|NCT00189540|3230838|Superiority or Other|||||||0.55|||||||Fisher Exact|||The comparison of groups at Month 3|
1759532|NCT00189540|3230839|Superiority or Other|||||||0.17|||||||ANCOVA|||Comparison made is the difference from baseline at Month 6.|
1759533|NCT00189540|3230839|Superiority or Other|||||||0.35|||||||ANCOVA|||Comparison made is the difference from baseline at Month 3.|
1759534|NCT00189488|3230840|Superiority or Other||Adjusted Treatment Difference|-4.1||||0.219|2-Sided|5.0|-12.2|4.0|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.||
1759583|NCT00186888|3230956|Superiority or Other (legacy)|||||||0.297|||||||ANOVA|||BCRP 15622: The null hypothesis is there is not a statistically significant difference between the genotype groups.|
1759675|NCT00182325|3231204|Superiority|||||||0.57|||||||t-test, 2 sided||||
1759535|NCT00189488|3230841|Superiority or Other||Adjusted Treatment Difference|-5.5||||0.186|2-Sided|95.0|-12.7|1.8|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.||
1759536|NCT00189488|3230842|Superiority or Other||Adjusted Treatment Difference (%)|2.0||||0.797|2-Sided|95.0|-12.5|16.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Difference between treatment groups in the percentage of participants with opioid analgesic use, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.||
1759537|NCT00189488|3230843|Superiority or Other||Adjusted Treatment Difference|0.5||||0.953|2-Sided|95.0|-1.5|2.5|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.||
1759538|NCT00189488|3230844|Superiority or Other||Adjusted Treatment Difference (%)|-2.6||||0.675|2-Sided|95.0|-14.2|9.0|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|Difference between treatment groups in the percentage of participants with severe oral mucositis, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|"Participants with Unknown incidence are treated as Yes when constructing the differences, 95% confidence intervals and p-value."|
1759539|NCT00189488|3230845|Superiority or Other||Adjusted Treatment Difference (%)|-6.5||||0.352|2-Sided|95.0|-19.4|6.4|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with Day 11 Methotrexate GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.||
1759540|NCT00189488|3230846|Superiority or Other||Adjusted Difference (%)|0.5||||0.929|2-Sided|95.0|-11.0|12.1|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with severe GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.||
1759541|NCT00189488|3230847|Superiority or Other||Adjusted Treatment Difference (%)|-17.9||||0.034|2-Sided|95.0|-33.4|-2.4|||Cochran-Mantel-Haenszel|Adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.|The difference between treatment groups in the percentage of participants with Grade 2 to 4 acute GVHD, adjusted for the stratification factors (TBI use, matched donor type, and source of donor cells) using the Cochran-Mantel-Haenszel weights.||
1759542|NCT00189423|3230854|Superiority or Other|||||||0.024|||||||Fisher Exact||||
1759543|NCT00189423|3230860|Superiority or Other|||||||0.681|||||||Fisher Exact||||
1759544|NCT00189423|3230860|Non-Inferiority or Equivalence|non-inferiority margin of 5%||||||0.0001||||||p value is for non-inferiority with a margin of 5% (exact binomial test)|Fisher Exact test, for non-inferiority||||
1759545|NCT00189423|3230861|Superiority or Other||Odds Ratio (OR)|1.58||||0.019|2-Sided|95.0|1.07|2.36|||Fisher Exact||||
1759546|NCT00189228|3230864|Superiority or Other (legacy)||||||<|0.01|||||||t-test, 2 sided|||This is not a drug study.|
1759547|NCT00189202|3230869|Other|||||||0.7|||||||Kaplan-Meier||||
1759548|NCT00189202|3230870|Equivalence|Equivalence margin 8% plus or minus 4.||||||0.28|||||||Mantel Haenszel||||
1759549|NCT00189098|3230873|Superiority or Other||Risk Difference (RD)|6.0|||||2-Sided|95.0|-12.0|24.0|||||Risk difference and confidence interval reported for participants who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up.||
1759550|NCT00189098|3230874|Superiority or Other||Risk Difference (RD)|15.0|||||2-Sided|95.0|-7.0|37.0|||||Risk difference and confidence interval reported for the use of additional systemic antibiotics other than the study medication between 12 weeks and 1 year follow-up.||
1759551|NCT00189098|3230875|Superiority or Other||Risk Difference (RD)|-7.0|||||2-Sided|95.0|-23.0|9.0|||||Risk difference and confidence interval reported for the use of additional systemic antibiotics other than the study medication between 6 to 12 weeks follow-up.||
1759552|NCT00189098|3230876|Superiority or Other||Risk Difference (RD)|-4.0|||||2-Sided|95.0|-22.0|14.0|||||Risk difference and confidence interval reported for eardrop usage between 12 weeks and 1 year follow-up.||
1759553|NCT00189098|3230877|Superiority or Other||Risk Difference (RD)|-12.0|||||2-Sided|95.0|-34.0|10.0|||||Risk difference and confidence interval reported for eardrop usage between 6 and 12 weeks follow-up.||
1759554|NCT00189098|3230878|Superiority or Other||Risk Difference (RD)|5.0|||||2-Sided|95.0|-12.0|22.0|||||Risk difference and confidence interval reported for 1 year follow-up.|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."|
1759555|NCT00189098|3230878|Superiority or Other||Risk Difference (RD)|-15.0|||||2-Sided|95.0|-34.0|4.0|||||Risk difference and confidence interval reported for 12 week follow-up|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."|
1759584|NCT00186888|3230956|Superiority or Other (legacy)|||||||0.245|||||||ANOVA|||BCRP 1143: The null hypothesis is there is not a statistically significant difference between the genotype groups.|
1759585|NCT00186888|3230957|Superiority or Other (legacy)|||||||0.106|||||||ANOVA|||CYP3A5*3: The null hypothesis is there is not a statistically significant difference between the genotype groups.|
1759556|NCT00189098|3230878|Superiority or Other||Risk Difference (RD)|-25.0|||||2-Sided|95.0|-44.0|-6.0|||||Risk difference and 95% confidence intervals reported for 6 weeks follow-up.|"Assuming a spontaneous recovery of 25% and a treatment effect of TMP-SMX of 50% (based on a retrospective study of children treated with TMP-SMX for COM at our hospital), and taking α=0.05 and a power of 0.80, we calculated that each group should consist of 50 children.~Rate differences with 95% confidence intervals were calculated at the three control visits to compare both groups for the outcome measures."|
1759557|NCT00187889|3230880|Superiority or Other||Mean Difference (Net)|-0.04|Standard Error of the Mean|0.39||0.92|2-Sided|95.0|-0.79|0.72|||Satterthwaite corrected t-test||The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups. This is a different outcome variable than the primary.|The null hypothesis is that treatments are equivalent on this outcome. The study was powered around the primary outcome. No adjustment for multiple comparisons was planned.|
1759558|NCT00187889|3230880|Superiority or Other||Mean Difference (Net)|-9.6|Standard Error of the Mean|6.7||0.15|2-Sided|95.0|-22.8|3.6||The P-value applies to this comparison, without adjustment, to the completers of the trial.|Satterthwaite corrected t-test||An expanded definition of the outcome measure is the difference between the percentage change (week 16) and the percentage change week 0). This is a calculation based on 4 measurements.|The null hypothesis is that the treatments are equivalent with respect to the primary outcome. The Satterthwaite corrected t-tests adjusts for potentially unequal variance in the groups.|
1759559|NCT00187135|3230903|Superiority or Other|||||||0.99|||||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of motion (Y/N)on pain (Y/N) while controlling for treatment.|
1759560|NCT00187135|3230904|Superiority or Other|||||||0.52|||||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in blood presure (BP) on pain (Y/N) while controlling for treatment.|
1759561|NCT00187135|3230905|Superiority or Other|||||||0.67|||||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in respiratory rate (RR) on pain (Y/N) while controlling for treatment.|
1759562|NCT00187135|3230906|Superiority or Other|||||||0.87|||||||GEE Model|||The generalized estimation equation (GEE) approach by Liang and Zeger was used to model the effects of 20% change in heart rate (HR) on pain (Y/N) while controlling for treatment.|
1759563|NCT00187135|3230907|Superiority or Other|||||||0.5||||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.|
1759564|NCT00187135|3230908|Superiority or Other|||||||0.5||||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. The sample size needed to ensure adequate statistical power for this comparison was obtained.|
1759565|NCT00187135|3230908|Superiority or Other|||||||0.5||||||To adjust for multiple comparisons, p-values less than 0.0167 are considered statistically significant.|McNemar|||The study was designed to achieve statistical power of 80% for this comparison. Due to the early termination of the study, the sample size needed to ensure adequate statistical power for this comparison was not obtained.|
1759566|NCT00186901|3230919|Superiority or Other|||||||0.21|||||||Kruskal Wallis||||
1759567|NCT00186901|3230920|Superiority or Other|||||||0.4|||||||Kruskal Wallis||||
1759568|NCT00186901|3230921|Superiority or Other||Correlation coefficient|0.48|||<|0.0001|2-Sided|95.0|0.3|0.63|||Z-test|||180 patients were assessed at 36 months and received a QCT Scan. 89 patients were also assessed using the DXA Scan. Comparison of the two methods used 89 paired studies to arrive at a correlation coefficient.|
1759569|NCT00186901|3230922|Superiority or Other||Correlation coefficient|0.53|||<|0.0001|2-Sided|95.0|0.36|0.66|||Z-test|||188 patients were assessed at baseline and received a QCT Scan. 90 patients were also assessed using the DEXA Scan. Comparison of the two methods used 90 paired studies to arrive at a correlation coefficient.|
1759570|NCT00186901|3230923|Superiority or Other||Correlation coefficient|0.54|||<|0.0001|2-Sided|95.0|0.38|0.67|||Z-test|||218 patients were assessed at 12 months and received a QCT Scan. 94 patients were also assessed using the DEXA Scan. Comparison of the two methods used 94 paired studies to arrive at a correlation coefficient.|
1759571|NCT00186901|3230924|Superiority or Other||Correlation coefficient|0.41|||<|0.0001|2-Sided|95.0|0.25|0.55|||Z-test|||275 received a QCT and 121 received a DXA scan. 121 paired scans were evaluated.|
1759572|NCT00186901|3230925|Superiority or Other|||||||0.0092|||||||Kruskal-Wallis||||
1759573|NCT00186901|3230926|Superiority or Other||Median Difference (Final Values)|-0.69||||0.0023||95.0|||||Wilcoxon (Mann-Whitney)||||
1759574|NCT00186901|3230927|Superiority or Other||Median Difference (Final Values)|-0.32||||0.0004||95.0|||||Wilcoxon (Mann-Whitney)||||
1759575|NCT00186901|3230928|Superiority or Other||Median Difference (Final Values)|-0.04||||0.31||95.0|||||Wilcoxon Test|||36 Month (End of Study) BMD Z-Score calculation where N=84|
1759576|NCT00186901|3230928|Superiority or Other||Median Difference (Final Values)|-0.04||||0.54||95.0|||||Wilcoxon Test|||24 Month BMD Z-Score calculation where N=91|
1759577|NCT00186901|3230928|Superiority or Other||Median Difference (Final Values)|-0.17||||0.99||95.0|||||Wilcoxon Test|||12 Month BMD Z-Score Calculation where N=109|
1759578|NCT00186901|3230928|Superiority or Other||Median Difference (Final Values)|-0.02||||0.86||95.0|||||Wilcoxon Test|||Baseline where N=134|
1759579|NCT00186888|3230956|Superiority or Other (legacy)|||||||0.424|||||||ANOVA|||Pgp Exon 26: The null hypothesis is there is not a statistically significant difference between the genotype groups.|
1759580|NCT00186888|3230956|Superiority or Other (legacy)|||||||0.616|||||||ANOVA|||Pgp Exon 21: The null hypothesis is there is not a statistically significant difference between the genotype groups.|
1759581|NCT00186888|3230956|Superiority or Other (legacy)|||||||0.844|||||||ANOVA|||BCRP Exon 5: The null hypothesis is there is not a statistically significant difference between the genotype groups.|
1759582|NCT00186888|3230956|Superiority or Other (legacy)|||||||0.372|||||||ANOVA|||BCRP Exon 2: The null hypothesis is there is not a statistically significant difference between the genotype groups.|
1759586|NCT00186888|3230957|Superiority or Other (legacy)|||||||0.452|||||||ANOVA|||CYP3A4*1B: The null hypothesis is there is not a statistically significant difference between the genotype groups.|
1759587|NCT00186888|3230958|Superiority or Other (legacy)||Binomial Proportion|91.7|||||2-Sided|95.0|65.1|99.6|||||||
1759588|NCT00186888|3230959|Superiority or Other (legacy)||Binomial Proportion|88.9|||||2-Sided|95.0|71.3|96.9|||||||
1759589|NCT00186628|3230966|Superiority or Other|||||||0.07|||||||Log Rank||||
1759590|NCT00186498|3230971|Superiority or Other (legacy)|||||||0.006||||||Test of within subjects contrast: CVLT Long Delay Free Recall Time 1 (baseline) vs Time 2 (30 days): Placebo (F 4.093) p= 0.071; Memantine (F 35.042) p=0.006|Regression, Linear||||
1759591|NCT00186485|3230972|Superiority or Other||||||<|0.01||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the CGI scores (F (4,88) = 5.31, p < .01) over the 4 week treatment period.|ANOVA|||Repeated Measures ANOVA with partial eta; p value was adjusted for multiple comparisons over the course of treatment|
1759592|NCT00186485|3230973|Superiority or Other||||||<|0.01||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the BDI total scores (F (4,96) = 19.35, p < .001) over the 4 week treatment period.,|ANOVA|||Repeated measures ANOVA with partial eta; accounts for multiple repeated measures over the course of treatment.|
1759593|NCT00186485|3230974|Superiority or Other||||||<|0.001||||||Repeated Measures ANOVAs over the course of the TMS treatments, by severity of depression on the HAM-D rating scale: total scores (F (4,96) = 19.88, p < .001) over the 4 week treatment period.|ANOVA|Repeated Measures Anova||ANOVA with partial eta accounts for multiple repeated measures over the course of treatment.|
1759594|NCT00186446|3230977|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t(19)= -8.93|||
1759595|NCT00186186|3230978|Superiority or Other||Percentage|54.0|||||2-Sided||||||||||
1759596|NCT00186186|3230979|Superiority or Other||||||<|1e-05|||||||Wilcoxon (Mann-Whitney)||||
1759597|NCT00186069|3230987|Superiority or Other|||||||0.95|||||||Fisher Exact||||
1759598|NCT00186069|3230988|Superiority or Other|||||||0.52|||||||Wilcoxon (Mann-Whitney)||||
1759599|NCT00186069|3230989|Superiority or Other||Risk Ratio (RR)|1.2||||0.68|2-Sided|95.0|0.77|1.86|||Fisher Exact||||
1759600|NCT00186056|3230990|Superiority or Other||||||<|0.26|||||||ANOVA|Interaction of HAMD * medication group F(2,26)=1.38, eta sq = .05|||
1759601|NCT00186017|3230995|Superiority or Other||||||>|0.1|||||||Wilcoxon (Mann-Whitney)||||
1759602|NCT00186017|3230996|Superiority or Other||||||>|0.1|||||||Wilcoxon (Mann-Whitney)||||
1759603|NCT00186017|3230997|Superiority or Other|||||||0.08|||||||Wilcoxon (Mann-Whitney)||||
1759604|NCT00185900|3231004|Superiority|||||||0.01|||||||Chi-squared||||
1759605|NCT00185458|3231026|Superiority or Other||||||<|0.001|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759606|NCT00185458|3231027|Superiority or Other|||||||0.062|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759607|NCT00185458|3231028|Superiority or Other|||||||0.175|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759608|NCT00185458|3231029|Superiority or Other||||||<|0.001|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759609|NCT00185458|3231030|Superiority or Other||||||<|0.001|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759610|NCT00185458|3231031|Superiority or Other||||||<|0.001|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759611|NCT00185458|3231032|Superiority or Other||||||<|0.001|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759612|NCT00185458|3231033|Superiority or Other||||||<|0.001|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759613|NCT00185458|3231034|Superiority or Other||||||<|0.001|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759614|NCT00185458|3231035|Superiority or Other|||||||0.054|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759615|NCT00185458|3231036|Superiority or Other||||||<|0.001|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759616|NCT00185458|3231037|Superiority or Other||||||<|0.001|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759617|NCT00185458|3231038|Superiority or Other||||||<|0.001|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759618|NCT00185458|3231039|Superiority or Other|||||||0.027|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759676|NCT00182325|3231205|Superiority|||||||0.46|||||||t-test, 2 sided||||
1759619|NCT00185458|3231041|Superiority or Other||||||<|0.001|||||||Friedman's two-way ANOVA|||This is a Friedman's two-way analysis of variance (ANOVA) to test the time effect within the treatment group. The null-hypothesis is that the means are equal at the time points tested.|
1759620|NCT00185458|3231043|Superiority or Other|||||||0.296|||||||Friedman's two-way ANOVA|||Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.|
1759621|NCT00185458|3231044|Superiority or Other|||||||0.128|||||||Friedman's two-way ANOVA|||Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested.|
1759622|NCT00185211|3231052|Superiority or Other|||||||0.0719||||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: Brain volume at screening||The null hypothesis H0: “The mean percentage change of brain volume at month 60 adjusted for the brain volume at screening is identical for both treatment arms.” was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA).|
1759623|NCT00185211|3231052|Superiority or Other|||||||0.1208||||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: Brain volume at screening||The null hypothesis H0: “The distribution of the percentage change of brain volume at month 60 adjusted for the brain volume at screening is identical for both treatment arms.” was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA).|
1759624|NCT00185211|3231053|Superiority or Other|||||||0.8558||||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: Volume of black holes at screening||The null hypothesis H0: “The mean absolute change of volume of black holes at month 60 adjusted for the volume of black holes at screening is identical for both treatment arms.” was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA).|
1759625|NCT00185211|3231053|Superiority or Other|||||||0.6619||||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: Volume of black holes at screening||The null hypothesis H0: “The distribution of the absolute change of volume of black holes at month 60 adjusted for the volume of black holes at screening is identical for both treatment arms.” was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA).|
1759626|NCT00185211|3231054|Superiority or Other|||||||0.9408||||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: T2 lesion volume at screening||The null hypothesis H0: “The mean absolute change of T2 lesion volume at month 60 adjusted for the T2 lesion volume at screening is identical for both treatment arms.” was tested against the corresponding two-sided alternative hypothesis based on a parametric analysis of covariance (ANCOVA).|
1759627|NCT00185211|3231054|Superiority or Other|||||||0.7801||||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: T2 lesion volume at screening||The null hypothesis H0: “The distribution of the absolute change of T2 lesion volume at month 60 adjusted for the T2 lesion volume at screening is identical for both treatment arms.” was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA).|
1759628|NCT00185211|3231055|Superiority or Other||Relative effect size|0.7351||||0.0435||95.0|0.5436|0.994||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|generalized linear model|Distribution: negative binomial distribution; covariate: number of Gd-enhancing lesions on T1 at screening|The direction of comparison is initial IFNB-1b versus initial placebo.|Assuming that the cumulative number of newly active lesions at month 60 follows a negative binomial distribution, a generalized linear model (logarithmic link function, covariate: number of Gd-enhancing lesions on T1 at BENEFIT screening) was set up in order to analyze the treatment effect on that MRI outcome.|
1759629|NCT00185211|3231055|Superiority or Other|||||||0.0062||||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: number of Gd-enhancing lesions on T1 at screening||The null hypothesis H0: “The distribution of the cumulative number of newly active lesions at month 60 adjusted for the number of Gadolinium (Gd)-enhancing lesions on T1 at screening is identical for both treatment arms.” was tested against the corresponding two-sided alternative hypothesis based on a non-parametric analysis of covariance (ANCOVA).|
1759630|NCT00185211|3231056|Superiority or Other|||||||0.8245||||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|ANCOVA|Variable used as covariate: MSFC Z-scores measured at baseline||The null hypothesis H0: “The mean MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score are identical for both treatment arms” was tested against the alternative hypothesis HA: “The mean MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score are not the same in the two treatment groups” based on a non-parametric analysis of covariance (ANCOVA).|
1759631|NCT00185211|3231056|Superiority or Other|||||||0.6078||||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|non-parametric ANCOVA|Variable used as covariate: MSFC Z-scores measured at baseline||The null hypothesis H0: “The distribution of MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score is identical for both treatment arms” was tested against the alternative hypothesis HA: “The distribution of MSFC Z-scores at month 60 adjusted for baseline MSFC Z-score is not the same in the two treatment groups” based on a non-parametric analysis of covariance (ANCOVA).|
1759641|NCT00185211|3231062|Superiority or Other|||||||0.0027||||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|Log Rank|||"The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was:~H0: The survival functions (i.e., the probability that time to CDMS is ≥ t) are identical for both treatment arms for all points in time t>0.~The two-sided alternative hypothesis was:~H1: The survival functions (i.e., the probability that time to CDMS is ≥ t) are not identical for both treatment arms for some points in time t>0."|
1759642|NCT00184548|3231086|Superiority or Other||Hodges-Lehmann shift estimate|2.0||||0.03||95.0|0.0|4.0|||Wilcoxon (Mann-Whitney)||||
1759632|NCT00185211|3231057|Superiority or Other||Risk Ratio (RR)|0.7971||||0.0141||95.0|0.665|0.9554||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|generalized linear Poisson regression|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Risk Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Relapse rate was analyzed by a generalized linear Poisson regression model with individual relapse counts as dependent variable, covariates: treatment arm, steroid use during first event, onset of disease and categorized number of T2 lesions at screening and offset variable natural log of time (in years) as difference between last clinical visit and baseline visit. The treatment effect on the relapse rate was of primary interest.|
1759633|NCT00185211|3231058|Superiority or Other||Hazard Ratio (HR)|0.797||||0.1265||95.0|0.595|1.066||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|Andersen-Gill Model|Covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|The time to recurrent relapses was modelled by an extension of Cox's PH regression model (Andersen-Gill Model) for recurrent events with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for recurrent relapses, i.e. hazard ratio = 1.|
1759634|NCT00185211|3231059|Superiority or Other||Hazard Ratio (HR)|0.583|||<|1e-06||95.0|0.474|0.718|||Regression, Cox|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b versus initial placebo, i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to McDonald MS was modelled by a Cox proportional hazards regression model with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (categories: 2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for McDonald MS, i.e. hazard ratio = 1.|
1759635|NCT00185211|3231059|Superiority or Other||||||<|6e-06||||||The two-sided error level for the exploratory analysis of the secondary outcome measures was of 0.05.|Log Rank|||"The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was:~H0: The survival functions (i.e., the probability that time to McDonald MS is ≥ t) are identical for both treatment arms for all points in time t>0.~The two-sided alternative hypothesis was:~H1: The survival functions (i.e., the probability that time to McDonald MS is ≥ t) are not identical for both treatment arms for some points in time t>0."|
1759636|NCT00185211|3231060|Superiority or Other|||||||0.3832|||||||ANCOVA|Variable used as covariate: FAMS TOI measured at baseline||The null hypothesis H0: “The mean FAMS TOI at month 60, adjusted for baseline FAMS TOI, is identical for both treatment arms” was tested against the alternative hypothesis HA: “The mean FAMS TOI at month 60, adjusted for baseline FAMS TOI, is not the same in the two treatment arms” using a parametric analysis of covariance (ANCOVA).|
1759637|NCT00185211|3231060|Superiority or Other|||||||0.888||||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|non-parametric ANCOVA|Variable used as covariate: FAMS TOI measured at baseline||The null hypothesis H0: “The distribution of FAMS TOI at month 60, adjusted for baseline FAMS TOI, is identical for both treatment arms” was tested against the alternative hypothesis HA: “The distribution of FAMS TOI at month 60, adjusted for baseline FAMS TOI, is not the same in the two treatment arms” using a non-parametric analysis of covariance (ANCOVA).|
1759638|NCT00185211|3231061|Superiority or Other||Hazard Ratio (HR)|0.764||||0.1604||97.47|0.497|1.174|||Regression, Cox|The variable used as additional covariate adjustment was volume of T2 lesions on screening MRI.|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to confirmed EDSS progression was modelled by a Cox proportional hazards regression model with the following covariates: treatment group and volume of T2 lesions on screening MRI. The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for confirmed EDSS progression, i.e. hazard ratio = 1.|
1759639|NCT00185211|3231061|Superiority or Other|||||||0.1768||||||A 2-sided error level of 0.0253 was used for analyses at month 36 and 60 in order to keep the study-wise error level at 0.05. A conditional sequential testing approach was used for the family of null hypotheses of the primary efficacy variables.|Log Rank|||The null hypothesis for comparison of initial IFNB-1b versus initial placebo treatment was: H0: The survival functions (i.e., the probability that time to confirmed EDSS progression is ≥ t) are not identical for both treatment arms for some points in time t>0. The two-sided alternative hypothesis was: H1: The survival functions (i.e., the probability that time to confirmed EDSS progression is ≥ t) are identical for both treatment arms for some points in time t>0.|
1759640|NCT00185211|3231062|Superiority or Other||Hazard Ratio (HR)|0.663||||0.0028||97.47|0.488|0.902|||Regression, Cox|covariate adjustment: steroid use during first event, onset of disease, categorized number of T2 lesions at screening|The direction of comparison is initial IFNB-1b (numerator) versus initial placebo (denominator), i.e. the Hazard Ratio represents the relative risk of initial IFNB-1b treatment compared to initial placebo treatment.|Time to CDMS was modelled by a Cox proportional hazards regression model with the following covariates: treatment group, steroid use during first event (yes vs. no), onset of disease (monofocal vs. multifocal) and number of T2 lesions at screening (categories: 2-4, 5-8 and at least 9 T2 lesions). The null hypothesis was: Initial IFNB-1b and initial placebo do not differ with regard to the hazard for CDMS, i.e. hazard ratio = 1.|
1759643|NCT00184548|3231087|Superiority or Other||Odds Ratio (OR)|1.175||||0.384||95.0|0.817|1.69|||Regression, Logistic||||
1759644|NCT00184548|3231088|Superiority or Other||Hodges-Lehmann shift estimate|1.0||||0.038||95.0|0.0|2.0|||Wilcoxon (Mann-Whitney)||||
1759677|NCT00182325|3231206|Superiority|||||||0.17|||||||t-test, 2 sided||||
1759645|NCT00184548|3231090|Superiority or Other||LS means|0.9||||0.308||95.0|-0.83|2.63|||ANCOVA|||Baseline covariates: Age, Injury Severity Score (ISS), Glasgow Coma ­Scale Score (GCS), International Normalized Ratio (INR) and acute lung injury.|
1759646|NCT00184548|3231092|Superiority or Other||Hazard Ratio (HR)|1.18||||0.589||95.0|0.64|2.17||Two-sided significance level 5%|Cox Proportional Hazards Model|||Treatment groups are compared using a Cox Proportional Hazards model with treatment as factor and adjusting for age, Injury Severity Score (ISS), Glasgow Coma ­Scale Score(GCS), International Normalized Ratio (INR) and acute lung injury.|
1759647|NCT00184548|3231092|Superiority or Other|||||||0.934||||||Two-sided significance level 5%|Regression, Logistic|||Test for Odds ratio=1, corresponding to a null hypothesis of no difference in mortality for patients who died between groups for Blunt Trauma. Odds-ratio is adjusted for baseline covariates: Age, Injury Severity Score (ISS), Glasgow Coma ­Scale Score (GCS), International Normalized Ratio (INR) and acute lung injury (P/F > 200). Missing covariates are imputed by the mean value.|
1759648|NCT00183729|3231107|Superiority|(no comments)|Mean Difference (Final Values)|8.0|Standard Error of the Mean|7.0||0.06|2-Sided||||||Mixed Models Analysis|||Null hypothesis: functional recovery would be the same in both groups. Power calculation: none. This was a pilot study.|
1759649|NCT00183729|3231109|Superiority||Mean Difference (Final Values)|2.0|Standard Error of the Mean|2.0||0.42|2-Sided||||||Mixed Models Analysis|||Null: the two groups would not differ in depressive symptoms over time (ie both groups would improve equally in terms of their depressive symptoms) Power calculation: none; this was a pilot study|
1759650|NCT00183625|3231111|Superiority or Other|||||||0.0176||||||The p-value listed is for the medication by time interaction.|Mixed Models Analysis|||Mixed effects regression of body mass index on medication group (risp or olanz), time (in days over first 18 months of study) and a group by time interaction with site and baseline timepoint indicators as covariates. The model included a random slope and intercept for time.|
1759651|NCT00183625|3231112|Superiority or Other|||||||0.66|||||||Regression, Linear||||
1759652|NCT00183456|3231114|Superiority or Other||Odds Ratio (OR)|2.41||||0.01|2-Sided|95.0|1.25|4.65|||Generalized Estimating Equations||||
1759653|NCT00183456|3231115|Superiority or Other||Odds Ratio (OR)|0.3||||0.01|2-Sided|95.0|0.14|0.64|||Generalized Estimating Equations||||
1759654|NCT00183456|3231116|Superiority or Other||Odds Ratio (OR)|0.33||||0.05|2-Sided|95.0|0.14|0.79|||Generalized Estimating Equations||||
1759655|NCT00183456|3231117|Superiority or Other||Odds Ratio (OR)|0.41||||0.01|2-Sided|95.0|0.21|0.77|||Generalized Estimating Equations||||
1759656|NCT00183456|3231118|Superiority or Other||Odds Ratio (OR)|0.47||||0.05|2-Sided|95.0|0.25|0.87|||Generalized Estimating Equations||||
1759657|NCT00183456|3231119|Superiority or Other||Odds Ratio (OR)|0.24||||0.01|2-Sided|95.0|0.09|0.68|||Generalized Estimating Equations||||
1759658|NCT00183456|3231120|Superiority or Other||Odds Ratio (OR)|2.82||||0.01|2-Sided|95.0|1.41|5.64|||Generalized Estimating Equations||||
1759659|NCT00183456|3231121|Superiority or Other||Odds Ratio (OR)|0.36||||0.05|2-Sided|95.0|0.16|0.84|||Generalized Estimating Equations||||
1759660|NCT00183456|3231122|Superiority or Other||Odds Ratio (OR)|2.68||||0.05|2-Sided|95.0|1.22|5.89|||Generalized Estimating Equations||||
1759661|NCT00183456|3231123|Superiority or Other||Odds Ratio (OR)|0.28|||<|0.01|2-Sided|95.0|0.13|0.63|||Generalized Estimating Equations||||
1759662|NCT00183196|3231171|Superiority|||||||0.04|||||||Regression, Cox|percent heavy drinking days at baseline was used as a covariate in the analysis as it was a predictor of overall survival independent of group.|||
1759663|NCT00183196|3231171|Superiority or Other||Hazard Ratio (HR)|0.529|Standard Error of the Mean|4.0|||2-Sided|95.0|0.281|0.997|||||||
1759664|NCT00183092|3231172|Superiority or Other||Mean Difference (Net)|0.8||||0.7||95.0||||Significance threshold p<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted change (worsening) in the quinacrine group.|
1759665|NCT00183092|3231173|Superiority or Other||Mean Difference (Net)|0.4||||0.71||95.0||||Significance threshold p<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.|
1759666|NCT00183092|3231174|Superiority or Other||Mean Difference (Net)|-0.7||||0.92||95.0||||Significance threshold p<0.05|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.|
1759667|NCT00183092|3231175|Superiority or Other||Mean Difference (Net)|0.5||||0.03||95.0||||Threshold for significance p<0.05|Quade's rank analysis of covariance|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.|
1759668|NCT00183092|3231176|Superiority or Other||Mean Difference (Net)|2.8||||0.01||95.0||||Significance threshold p<0.05|Quade's rank analysis of covariance|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.|
1759669|NCT00183092|3231177|Superiority or Other||Mean Difference (Net)|7.9||||0.36||95.0||||significance threshold p=0.05|Quade's rank analysis of covariance|||The difference between scores, adjusted for Month-0 performance.|
1759670|NCT00183092|3231178|Superiority or Other||Mean Difference (Net)|1.5||||0.54||95.0||||Threshold for statistical significance = 0.05. One subject in the placebo group was administered only 25 items on the MMSE due to visual impairment, and this subject's score was scaled based on percentage correct.|ANCOVA|||The difference between change scores, adjusted for Month-0 performance. Positive adjusted differences indicate greater adjusted change (worsening) in the placebo group; negative indicate greater adjusted changed (worsening) in the quinacrine group.|
1759671|NCT00183092|3231179|Superiority or Other||Cox Proportional Hazard|1.43||||0.43|2-Sided|95.0|0.58|3.53|||Regression, Cox||||
1759672|NCT00182754|3231188|Superiority|||||||0.17|||||||Log Rank||||
1759678|NCT00182325|3231207|Superiority|||||||0.57|||||||t-test, 2 sided||||
1759679|NCT00182325|3231208|Superiority|||||||0.67|||||||t-test, 2 sided||||
1759680|NCT00182325|3231209|Superiority|||||||0.68|||||||t-test, 2 sided||||
1759681|NCT00182325|3231210|Superiority|||||||0.84|||||||t-test, 2 sided||||
1759682|NCT00182325|3231211|Superiority||||||<|0.0001|||||||t-test, 2 sided||||
1759683|NCT00182078|3231216|Superiority or Other||Mean Difference (Final Values)|0.9|Standard Deviation|4.4|=|0|2-Sided|95.0|||||t-test, 2 sided||||
1759684|NCT00182078|3231217|Superiority or Other||Mean Difference (Final Values)|5.1|Standard Deviation|3.9|<|0.001|2-Sided|95.0|||||t-test, 2 sided||||
1759685|NCT00182078|3231218|Superiority or Other||Mean Difference (Final Values)|3.8|Standard Deviation|3.4|=|0|2-Sided|95.0|||||t-test, 2 sided||||
1759686|NCT00181961|3231226|Superiority|||||||0.016|||||||Wilcoxon (Mann-Whitney)||||
1759687|NCT00181363|3231236|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1759688|NCT00181363|3231237|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1759689|NCT00181363|3231238|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1759690|NCT00181363|3231239|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1759691|NCT00181363|3231240|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1759692|NCT00181155|3231247|Superiority or Other||||||<|0.02||||||vs. baseline|Two-sided paired t tests||||
1759693|NCT00181155|3231248|Superiority or Other||||||<|0.007||||||vs. baseline|Two-sided paired t tests||||
1759694|NCT00180713|3231251|Superiority|||||||0.26|||||||ANOVA||||
1759695|NCT00180713|3231252|Superiority|||||||0.041|||||||ANOVA||||
1759696|NCT00180713|3231253|Superiority|||||||0.4|||||||ANOVA|||Analysis was performed by intention to treat at 6 months and per protocol at 12 months. Missing variables were replaced with medians or means (for variables missing at baseline) or with expected variables calculated on the percentage change between baseline and 24 weeks observed for the group (placebo or statin) as a whole (a technique called imputation). Missing variables accounted for less than 5% of the data and there were no missing CMR data at baseline.|
1759697|NCT00180713|3231254|Superiority|||||||0.86|||||||ANOVA|||Analysis was performed by intention to treat at 6 months and per protocol at 12 months. Missing variables were replaced with medians or means (for variables missing at baseline) or with expected variables calculated on the percentage change between baseline and 24 weeks observed for the group (placebo or statin) as a whole (a technique called imputation). Missing variables accounted for less than 5% of the data and there were no missing CMR data at baseline.|
1759698|NCT00180713|3231255|Superiority|||||||0.028|||||||ANOVA||||
1759699|NCT00180661|3231264|Superiority|||||||0.005|||||||t-test, 2 sided||||
1759700|NCT00180661|3231265|Superiority|||||||0.001|||||||t-test, 2 sided||||
1759701|NCT00180479|3231308|Non-Inferiority or Equivalence|Study had 89% statistical power based on major secondary endpoint to prove non-inferiority of XIENCE® V to TAXUS®, non-inferiority delta=5.5%, true TVF rate 9.4% in both arms with overall 5% alpha (one-sided), assuming 1% subject dropout rate.|||||<|0.0001|||||||t-test, 1 sided|||Null hypothesis was evaluated using a non-inferiority Z statistic. Non-inferiority was defined as a one-sided alpha of 0.05 and a difference in TVF rate of no more than 5.5%.|
1759702|NCT00180479|3231309|Non-Inferiority or Equivalence|Sample size calculation for endpoint of in-segment LL at 240 days is based on these assumptions: one-tailed non-inferiority= (δ)=0.025, Power=99%, Randomization ratio 2:1, True mean in-seg. LL is assumed to be 0.24 mm in both arms.|||||<|0.0001|||||||t-test, 1 sided|||Primary endpoint analyzed for intent-to-treat & per-treatment evaluable pop. Hypothesis test based on per-subject analysis of intent-to-treat pop. using analysis lesion. The null hypothesis evaluated using non-inferiority test with asymptotic test statistic.|
1759703|NCT00180271|3231314|Superiority||Hazard Ratio (HR)|0.67||||0.001|2-Sided|95.0|0.53|0.86|||Andersen-Gill|Andersen-Gill model performed, adjusted for a previous HF event in the study, stratified by ischemic status and using robust variance estimation.|Model adjusted for previously experienced heart failure event in the study. Hazard Ratio (95% CI) comparing patients with a previous heart failure event to those patients without a prior heart failure event equaled 8.84 (6084, 11.43), p<0.001.||
1759704|NCT00180271|3231315|Superiority or Other||Hazard Ratio (HR)|0.66|||<|0.001|2-Sided|95.0|0.52|0.84||The trial involved prespecified event monitoring at up to 20 successive periods by an independent DSMB to permit trial termination if the CRT-D was superior to, inferior to, or not different from ICD according to prespecified stopping rules.|Log Rank||A Hazard ratio < 1.0 would indicate that the result favors CRT-D.|The trial utilized a Wang-Tsiatis (delta=0.1) group-sequential design with 95% power to detect a hazard ratio of 0.75 at a two-sided significance level of 0.05. Primary analysis based on statistical evaluation comparing the life-table event-free survival time graphs for CRT-D and ICD-only arms of the trial. Stratified Cox proportional-hazards regression was used to estimate a hazard ratio and statistical significance was evaluated with the log-rank test. Stratified by center and ischemic status.|
1759705|NCT00179621|3231334|Superiority or Other|||||||0.113|||||||ANOVA||||
1759706|NCT00179621|3231334|Superiority or Other|||||||0.062|||||||ANOVA||||
1759707|NCT00179621|3231335|Superiority or Other|||||||0.08|||||||ANOVA||||
1759708|NCT00179621|3231335|Superiority or Other|||||||0.054|||||||ANOVA||||
1759709|NCT00179621|3231336|Superiority or Other||||||<|0.05|||||||ANOVA||||
1759710|NCT00179621|3231336|Superiority or Other||||||<|0.05|||||||ANOVA||||
1759711|NCT00179621|3231346|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus >0) to compare lenalidomide treatment with placebo.|||
1759712|NCT00179621|3231346|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus >0) to compare lenalidomide treatment with placebo.|||
1759713|NCT00179621|3231347|Superiority or Other||||||<|0.001||||||To compare the response rates of Lenalidomide 10 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus >0) to compare lenalidomide treatment with placebo.|||
1759714|NCT00179621|3231347|Superiority or Other||||||<|0.001||||||To compare the response rates of Lenalidomide 5 mg QD vs. placebo, the Hochberg procedure was used to control the familywise error rate of 0.05.|Cochran-Mantel-Haenszel|Stratified by International Prognostic Scoring System (IPSS) score (IPSS combined score =0 versus >0) to compare lenalidomide treatment with placebo.|||
1759715|NCT00179478|3231357|Superiority|||||||0.5||||||a priori threshold for statistical significant was a p value less than 0.01|Fisher Exact||||
1759716|NCT00179478|3231358|Superiority|||||||0.61||||||a priori threshold for statistical significance was a p value < 0.01|Fisher Exact||||
1759717|NCT00179478|3231359|Superiority|||||||0.02||||||a priori threshold for statistical significance was a p value less than 0.01|Wilcoxon (Mann-Whitney)||||
1759718|NCT00179478|3231360|Superiority|||||||0.001||||||Based on adjusted Hazard Ratio (HR)|Regression, Cox|HR adjusted for age, onset event type, baseline brain MRI T2 lesion and number and baseline number of gad enhancing lesions|||
1759719|NCT00179309|3231365|Superiority or Other|||||||0.12||||||Multiple comparisons were not done.|Log Rank|||48 evaluable pts will be randomized in a 1:1 ratio between two arms (24 evaluable pts per arm). Using standard formulae (e.g. nQuery Advisor v5), this number was selected to provide 80% power to detect a difference between 4.2 month median progression free survival (PFS) on the docetaxel alone arm and 8 month median PFS on the arm receiving PANVAC plus docetaxel, with a one-tailed alpha=0.10,assuming 36 months accrual and an additional 12 months of follow-up after the last pt has been enrolled.|
1759720|NCT00179010|3231370|Superiority or Other|||||||0.854|||||||ANOVA||||
1759721|NCT00178711|3231385|Superiority or Other||Risk Ratio (RR)|1.08|||=|0|2-Sided|95.0|0.76|1.53|||Regression, Logistic|||The primary hypothesis was a two-sided test assessing whether the induction of hypothermia modified the percentage of subjects with poor outcomes at 6 months after injury. Percentages in each group were compared using a generalized linear model with a binomial distribution and log link function, logistic regression model with admission age and baseline GCS as covariates.|
1759722|NCT00178633|3231391|Superiority or Other||||||<|0.0001|||||||ANOVA||||
1759723|NCT00178503|3231392|Superiority or Other||Linear p|0.0|||<|0.001||0.0|||||ANOVA||||
1759724|NCT00178503|3231393|Superiority or Other||Linear p|0.005||||0.005|||||||ANOVA||||
1759725|NCT00178503|3231394|Superiority or Other||Linear trend P value|0.0|||=|0|||||||ANOVA|||Data were analyzed using SPSS-PC repeated measures one-way analysis of variance (ANOVA), with MPH dosing regimen as the within-subjects variable.|
1759726|NCT00178126|3231407|Superiority or Other|||||||0.04|||||||Fisher Exact||||
1759727|NCT00177671|3231419|Superiority or Other||Hazard Ratio (HR)|3.97|Standard Deviation|2.09||0.05|2-Sided|95.0|1.0|4.41|||Log Rank|||We followed the intention to treat principle. We used Kaplan-Meier curves to quantify the percentage of participants who were free of depression recurrence over time. Cox proportional hazard models quantified hazard ratios comparing the 2 treatment groups.|
1759728|NCT00177294|3231426|Superiority or Other|||||||0.14|||||||Regression, Logistic|||We conducted Cox regreassion analyses of time to remission and logistic modeling for rates of remission. We tested group difference in Hamilton depession ratings over time via mixed-effects modeling.|
1759729|NCT00176202|3231531|Superiority or Other||||||<|0.01|||||||Chi-squared||||
1759730|NCT00176202|3231531|Superiority or Other||||||<|0.01|||||||Chi-squared|||baseline is compared to LOCF to determine the p value.|
1759731|NCT00176202|3231532|Superiority or Other||Effect size|-1.33|||<|0.01|2-Sided||||||Chi-squared||||
1759732|NCT00176202|3231532|Superiority or Other||effect size|-1.59|||<|0.01|2-Sided|||||In case of both risperidone and divalproex sodium.|Chi-squared||||
1759733|NCT00176202|3231533|Superiority or Other|||||||0.01|||||||Chi-squared||||
1759734|NCT00176202|3231533|Superiority or Other||||||<|0.01|||||||Chi-squared||||
1759735|NCT00176202|3231534|Superiority or Other||||||<|0.01|||||||Chi-squared||||
1759736|NCT00176202|3231534|Superiority or Other||||||<|0.01|||||||Chi-squared||||
1759737|NCT00175825|3231563|Superiority or Other||Percent reduction over Placebo|22.1|||=|0|2-Sided|95.0|7.6|34.3|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.|
1759738|NCT00175825|3231563|Superiority or Other||Percent reduction over Placebo|14.9|||=|0|2-Sided|95.0|-0.8|28.2|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.|
1759739|NCT00175825|3231563|Superiority or Other||Percent reduction over Placebo|9.8|||=|0|2-Sided|95.0|-7.2|24.0|||ANCOVA|||ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.|
1759740|NCT00174967|3231589|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759741|NCT00174967|3231589|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759742|NCT00174967|3231589|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759743|NCT00174967|3231590|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759744|NCT00174967|3231590|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759745|NCT00174967|3231590|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759746|NCT00174967|3231591|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759747|NCT00174967|3231591|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759748|NCT00174967|3231591|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759749|NCT00174967|3231592|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759750|NCT00174967|3231592|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759751|NCT00174967|3231592|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759752|NCT00174967|3231593|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759753|NCT00174967|3231593|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759754|NCT00174967|3231593|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759755|NCT00174967|3231594|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759756|NCT00174967|3231594|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759757|NCT00174967|3231594|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using a t-test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|t-test, 2 sided||||
1759758|NCT00174967|3231595|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|Fisher Exact||||
1759759|NCT00174967|3231595|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|Fisher Exact||||
1759760|NCT00174967|3231595|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|Fisher Exact||||
1759761|NCT00174967|3231596|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|Fisher Exact||||
1759762|NCT00174967|3231596|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|Fisher Exact||||
1759763|NCT00174967|3231596|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|Fisher Exact||||
1759764|NCT00174967|3231597|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|Fisher Exact||||
1759765|NCT00174967|3231597|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|Fisher Exact||||
1759766|NCT00174967|3231597|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|Fisher Exact||||
1759767|NCT00174967|3231598|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|Fisher Exact||||
1759768|NCT00174967|3231598|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|Fisher Exact||||
1759769|NCT00174967|3231598|Superiority or Other||||||<|0.001||||||Pairwise comparisons between placebo and each of the febuxostat treatment groups were performed using Fisher’s exact test. Adjustment for multiple comparisons was made using Hochberg’s procedure.|Fisher Exact||||
1759770|NCT00174954|3231599|Superiority or Other|||||||0.02||||||The a priori threshold for statistical significance is 0.05.|paired t-test||||
1759771|NCT00174954|3231600|Superiority or Other|||||||0.785||||||The a priori threshold for statistical significance was 0.05.|paired t-test||||
1759772|NCT00174915|3231617|Superiority or Other|||||||0.311||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759804|NCT00174915|3231620|Superiority or Other|||||||0.309||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759773|NCT00174915|3231617|Superiority or Other|||||||0.581||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759774|NCT00174915|3231617|Superiority or Other|||||||0.749||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759775|NCT00174915|3231617|Superiority or Other|||||||0.837||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759776|NCT00174915|3231617|Superiority or Other|||||||0.069||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759777|NCT00174915|3231617|Superiority or Other|||||||0.106||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759778|NCT00174915|3231617|Superiority or Other|||||||0.076||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons..|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL)|||
1759779|NCT00174915|3231617|Superiority or Other|||||||0.428||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759780|NCT00174915|3231617|Superiority or Other|||||||0.756||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759781|NCT00174915|3231617|Superiority or Other|||||||0.645||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759782|NCT00174915|3231618|Superiority or Other|||||||0.643||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759783|NCT00174915|3231618|Superiority or Other|||||||0.337||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759784|NCT00174915|3231618|Superiority or Other|||||||0.705||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759785|NCT00174915|3231618|Superiority or Other|||||||0.139||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759786|NCT00174915|3231618|Superiority or Other|||||||0.662||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759787|NCT00174915|3231618|Superiority or Other|||||||0.077||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759788|NCT00174915|3231618|Superiority or Other|||||||0.99||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759789|NCT00174915|3231618|Superiority or Other|||||||0.442||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759790|NCT00174915|3231618|Superiority or Other|||||||0.078||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759791|NCT00174915|3231618|Superiority or Other|||||||0.683||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759792|NCT00174915|3231619|Superiority or Other|||||||0.521||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759793|NCT00174915|3231619|Superiority or Other|||||||0.197||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759794|NCT00174915|3231619|Superiority or Other|||||||0.659||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759795|NCT00174915|3231619|Superiority or Other|||||||0.056||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759796|NCT00174915|3231619|Superiority or Other|||||||0.969||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759797|NCT00174915|3231619|Superiority or Other|||||||0.062||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759798|NCT00174915|3231619|Superiority or Other|||||||0.598||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759799|NCT00174915|3231619|Superiority or Other|||||||0.577||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759800|NCT00174915|3231619|Superiority or Other|||||||0.05||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759801|NCT00174915|3231619|Superiority or Other|||||||0.949||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759802|NCT00174915|3231620|Superiority or Other|||||||0.385||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759803|NCT00174915|3231620|Superiority or Other|||||||0.759||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759805|NCT00174915|3231620|Superiority or Other|||||||0.56||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759806|NCT00174915|3231620|Superiority or Other|||||||0.104||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759807|NCT00174915|3231620|Superiority or Other|||||||0.278||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759808|NCT00174915|3231620|Superiority or Other|||||||0.679||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759809|NCT00174915|3231620|Superiority or Other|||||||0.579||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759810|NCT00174915|3231620|Superiority or Other|||||||0.822||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759811|NCT00174915|3231620|Superiority or Other|||||||0.699||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759812|NCT00174915|3231621|Superiority or Other|||||||0.844||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759813|NCT00174915|3231621|Superiority or Other|||||||0.807||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759814|NCT00174915|3231621|Superiority or Other|||||||0.649||||||Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759815|NCT00174915|3231621|Superiority or Other|||||||0.415||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759816|NCT00174915|3231621|Superiority or Other|||||||0.247||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759817|NCT00174915|3231621|Superiority or Other|||||||0.154||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759818|NCT00174915|3231621|Superiority or Other|||||||0.809||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759819|NCT00174915|3231621|Superiority or Other|||||||0.381||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759820|NCT00174915|3231621|Superiority or Other|||||||0.32||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759821|NCT00174915|3231621|Superiority or Other|||||||0.789||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1759822|NCT00174915|3231622|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759823|NCT00174915|3231622|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759824|NCT00174915|3231622|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759825|NCT00174915|3231622|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759826|NCT00174915|3231622|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759827|NCT00174915|3231622|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759828|NCT00174915|3231622|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759829|NCT00174915|3231622|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759830|NCT00174915|3231622|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759831|NCT00174915|3231622|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759832|NCT00174915|3231623|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759934|NCT00174382|3231673|Superiority or Other||Median Difference (Net)|-1.85|Standard Error of the Mean|2.12||0.385||95.0|-6.03|2.34|||Mixed Models Analysis||||
1759833|NCT00174915|3231623|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759834|NCT00174915|3231623|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759835|NCT00174915|3231623|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759836|NCT00174915|3231623|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759837|NCT00174915|3231623|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759838|NCT00174915|3231623|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759839|NCT00174915|3231623|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759840|NCT00174915|3231623|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759841|NCT00174915|3231623|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the ANOVA model with treatment and baseline renal function as factors. Statistical significance was determined at the 0.05 level without adjustments for multiple comparisons.|ANOVA||||
1759842|NCT00174915|3231624|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759843|NCT00174915|3231624|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759844|NCT00174915|3231624|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759845|NCT00174915|3231624|Superiority or Other||||||<|0.074||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759846|NCT00174915|3231624|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759847|NCT00174915|3231624|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759848|NCT00174915|3231624|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759849|NCT00174915|3231624|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759850|NCT00174915|3231624|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759851|NCT00174915|3231624|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759852|NCT00174915|3231625|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759853|NCT00174915|3231625|Superiority or Other||||||<|0.091||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759854|NCT00174915|3231625|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759855|NCT00174915|3231625|Superiority or Other||||||<|0.011||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759856|NCT00174915|3231625|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759857|NCT00174915|3231625|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759858|NCT00174915|3231625|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759859|NCT00174915|3231625|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759860|NCT00174915|3231625|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759861|NCT00174915|3231625|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759862|NCT00174915|3231626|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759863|NCT00174915|3231626|Superiority or Other||||||<|0.479||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759864|NCT00174915|3231626|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759865|NCT00174915|3231626|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759866|NCT00174915|3231626|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759867|NCT00174915|3231626|Superiority or Other||||||<|0.001||||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759868|NCT00174915|3231626|Superiority or Other||||||<|0.001||||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759869|NCT00174915|3231626|Non-Inferiority or Equivalence|Non-inferiority of febuxostat 120 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is > -10%.|Difference in percentage|42.7|||<|||97.5|34.0|51.3|||||||
1759870|NCT00174915|3231626|Non-Inferiority or Equivalence|Non-inferiority of febuxostat 80 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is > -10%.|Difference in percentage|25.7|||<|||97.5|16.7|34.7|||||||
1759871|NCT00174915|3231626|Superiority or Other||||||<|0.001||||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759872|NCT00174915|3231626|Superiority or Other||||||<|0.001||||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL v. >1.5 mg/dL).|||
1759873|NCT00174915|3231626|Superiority or Other||||||<|0.001||||||The overall 0.05 level of significance for the multiple comparisons of each febuxostat dose to placebo was controlled using Hochberg's method. The p-value was statistically significant.|Cochran-Mantel-Haenszel|The Cochran-Mantel-Haenszel test was stratified by baseline renal function (serum creatinine ≤1.5 mg/dL versus [v.] >1.5 mg/dL).|||
1759874|NCT00174785|3231627|Superiority or Other||Hazard Ratio (HR)|0.71||||0.03||95.0|0.51|0.98||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The comparison was performed at the 5% level using a 2-sided Log rank|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of adjudicated cardiovascular death for the dronedarone group compared with the placebo group.||
1759875|NCT00174785|3231628|Superiority or Other||Hazard Ratio (HR)|0.7||||0.025||95.0|0.51|0.96||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of cardiovascular death for the dronedarone group compared with the placebo group.||
1759935|NCT00174382|3231673|Superiority or Other||Mean Difference (Net)|2.0|Standard Error of the Mean|1.16||0.218||95.0|-1.2|5.19|||Mixed Models Analysis||||
1759876|NCT00174785|3231629|Superiority or Other||Hazard Ratio (HR)|0.74|||<|0.0001||95.0|0.67|0.82||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of first hospitalization for cardiovascular reason for the dronedarone group compared with the placebo group.||
1759877|NCT00174785|3231630|Superiority or Other||Hazard Ratio (HR)|0.84||||0.18||95.0|0.66|1.08||Cumulative incidences calculated in each group using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. Hierarchical procedure applied to secondary efficacy endpoints testing to protect the global type I error.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of death from any cause for the dronedarone group compared with the placebo group.||
1759878|NCT00174785|3231631|Superiority or Other||Hazard Ratio (HR)|0.76|||<|0.0001||95.0|0.69|0.84||Cumulative incidence functions in each treatment group were calculated using non-parametric Kaplan-Meier estimates. Median time-to-event was not reached in any group. The primary comparison was performed at the 5% level using a 2-sided Log rank test.|Log Rank||The hazard ratio was estimated by a Cox's proportional hazard model with treatment arm factor. It represents the relative hazard of first hospitalization for cardiovascular reason or death for the dronedarone group compared with the placebo group.||
1759879|NCT00174460|3231633|Superiority or Other||Mean Difference (Final Values)|3.563|Standard Error of the Mean|0.708|<|0.001|2-Sided|95.0|2.134|4.992|||Mixed models analysis|Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit*treatment and target height SDS.||Treatment difference Month 24|
1759880|NCT00174460|3231633|Superiority or Other||Mean Difference (Final Values)|4.585|Standard Error of the Mean|0.3859|<|0.001|2-Sided|95.0|3.806|5.363|||Mixed models analysis|Results from repeated measure mixed models analysis adjusted for baseline height, sex, age, visit, visit*treatment and target height SDS.||Treatment difference Month 12|
1759881|NCT00174460|3231635|Superiority or Other||Mean Difference (Final Values)|0.688|Standard Error of the Mean|0.1519|<|0.001|2-Sided|95.0|0.382|0.994|||Mixed models analysis|Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit*treatment and target height SDS.||Treatment difference Month 24|
1759882|NCT00174460|3231635|Superiority or Other||Mean Difference (Final Values)|0.998|Standard Error of the Mean|0.1095|<|0.001|2-Sided|95.0|0.778|1.219|||Mixed models analysis|Results from repeated measures mixed models analysis adjusted for baseline height SDS, visit, visit*treatment and target height SDS.||Treatment difference Month 12|
1759883|NCT00174460|3231638|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.329||0.519|2-Sided|95.0|-0.52|0.96|||ANCOVA|Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.||Treatment difference Month 24|
1759884|NCT00174460|3231638|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.42||0.844|2-Sided|95.0|-0.88|1.05|||ANCOVA|Results from ANCOVA adjusted for baseline hand grip strength SDS and target height SDS; LOCF.||Treatment difference Month 12|
1759885|NCT00174460|3231639|Superiority or Other||Mean Difference (Final Values)|0.114|Standard Error of the Mean|0.4703||0.82|2-Sided|95.0|-1.192|1.42|||ANCOVA|Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.||Treatment difference Month 24|
1759886|NCT00174460|3231639|Superiority or Other||Mean Difference (Final Values)|0.56|Standard Error of the Mean|0.5061||0.331|2-Sided|95.0|-0.846|1.965|||ANCOVA|Results from ANCOVA adjusted for baseline strength-strain index SDS and target height SDS; LOCF.||Treatment difference Month 12|
1759887|NCT00174460|3231642|Superiority or Other||Mean Difference (Final Values)|1.626|Standard Error of the Mean|0.6536||0.068|2-Sided|95.0|-0.189|3.44|||ANCOVA|Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24|
1759888|NCT00174460|3231642|Superiority or Other||Mean Difference (Final Values)|2.31|Standard Error of the Mean|0.4542||0.007|2-Sided|95.0|1.049|3.572|||ANCOVA|Results from ANCOVA adjusted for baseline muscle cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12|
1759889|NCT00174460|3231643|Superiority or Other||Mean Difference (Final Values)|0.292|Standard Error of the Mean|0.4432||0.547|2-Sided|95.0|-0.939|1.522|||ANCOVA|Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24|
1759890|NCT00174460|3231643|Superiority or Other||Mean Difference (Final Values)|0.135|Standard Error of the Mean|1.1499||0.914|2-Sided|95.0|-3.524|3.795|||ANCOVA|Results from ANCOVA adjusted for baseline total cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12|
1759891|NCT00174460|3231644|Superiority or Other||Mean Difference (Final Values)|-1.205|Standard Error of the Mean|0.8991||0.251|2-Sided|95.0|-3.701|1.292|||ANCOVA|Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 24|
1759892|NCT00174460|3231644|Superiority or Other||Mean Difference (Final Values)|-0.482|Standard Error of the Mean|0.9666||0.653|2-Sided|95.0|-3.558|2.595|||ANCOVA|Results from ANCOVA adjusted for baseline cortical cross-sectional area SDS and target height SDS; LOCF.||Treatment difference Month 12|
1759893|NCT00174460|3231645|Superiority or Other||Mean Difference (Final Values)|5.615|Standard Error of the Mean|0.6591|<|0.001|2-Sided|95.0|4.266|6.963|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.||Treatment difference|
1759894|NCT00174460|3231646|Superiority or Other||Mean Difference (Final Values)|0.717|Standard Error of the Mean|0.6027||0.3|2-Sided|95.0|-0.956|2.391|||ANCOVA|Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.||Treatment difference Month 24|
1759895|NCT00174460|3231646|Superiority or Other||Mean Difference (Final Values)|-0.892|Standard Error of the Mean|0.8161||0.336|2-Sided|95.0|-3.158|1.374|||ANCOVA|Results from ANCOVA adjusted for baseline volumetric cortical bone mineral density SDS and target height SDS; LOCF.||Treatment difference Month 12|
1759896|NCT00174460|3231647|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|1.065||0.919|2-Sided|95.0|-2.11|2.32|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 24|
1760090|NCT00165698|3232189|Superiority or Other|||||||0.26|||||||Symbols rank sum test||||
1759897|NCT00174460|3231647|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|1.188||0.959|2-Sided|95.0|-2.42|2.54|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 12|
1759898|NCT00174460|3231648|Superiority or Other||Mean Difference (Final Values)|-0.23|Standard Error of the Mean|0.345||0.506|2-Sided|95.0|-0.94|0.48|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 24|
1759899|NCT00174460|3231648|Superiority or Other||Mean Difference (Final Values)|-0.37|Standard Error of the Mean|0.405||0.364|2-Sided|95.0|-1.21|0.46|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, sex, and age; LOCF.||Treatment difference Month 12|
1759900|NCT00174460|3231649|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.758||0.537|2-Sided|95.0|-2.04|1.09|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.||Treatment difference Month 24|
1759901|NCT00174460|3231649|Superiority or Other||Mean Difference (Final Values)|-2.7|Standard Error of the Mean|0.497|<|0.001|2-Sided|95.0|-3.73|-1.68|||ANCOVA|Results from ANCOVA adjusted for baseline skinfold thickness, target height SDS, age, and sex; LOCF.||Treatment difference Month 12|
1759902|NCT00174460|3231650|Superiority or Other||Mean Difference (Final Values)|0.719|Standard Error of the Mean|0.1606|<|0.001|2-Sided|95.0|0.39|1.047|||ANCOVA|Results from ANCOVA adjusted for baseline height SDS and target height SDS; LOCF.||Treatment difference Month 24|
1759903|NCT00174460|3231651|Superiority or Other||Mean Difference (Final Values)|4.064|Standard Error of the Mean|0.9822|<|0.001|2-Sided|95.0|2.049|6.08|||ANCOVA|Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.||Treatment difference Month 24|
1759904|NCT00174460|3231651|Superiority or Other||Mean Difference (Final Values)|4.54|Standard Error of the Mean|0.3661|<|0.001|2-Sided|95.0|3.789|5.291|||ANCOVA|Results from ANCOVA adjusted for baseline height, target height SDS, sex, and age; LOCF.||Treatment difference Month 12|
1759905|NCT00174460|3231652|Superiority or Other||Mean Difference (Final Values)|-1.074|Standard Error of the Mean|0.7089||0.141|2-Sided|95.0|-2.524|0.376|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity SDS and target height SDS; LOCF.||Treatment difference|
1759906|NCT00174460|3231653|Superiority or Other||Mean Difference (Final Values)|-0.884|Standard Error of the Mean|0.5327||0.108|2-Sided|95.0|-1.977|0.208|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.||Treatment difference Month 24|
1759907|NCT00174460|3231653|Superiority or Other||Mean Difference (Final Values)|4.415|Standard Error of the Mean|0.395|<|0.001|2-Sided|95.0|3.605|5.225|||ANCOVA|Results from ANCOVA adjusted for baseline growth velocity, target height SDS, sex, and age; LOCF.||Treatment difference Month 12|
1759908|NCT00174460|3231654|Superiority or Other||Mean Difference (Final Values)|0.991|Standard Error of the Mean|0.1067|<|0.001|2-Sided|95.0|0.773|1.21|||ANCOVA|Results from analysis of covariance method (ANCOVA) adjusted for baseline height SDS and target height SDS; Last observation carried forward (LOCF).||Treatment difference|
1759909|NCT00174382|3231665|Superiority or Other|||||||0.038|||||||Mixed Models Analysis||||
1759910|NCT00174382|3231665|Superiority or Other||Mean Difference (Net)|-1.09|Standard Error of the Mean|0.68||0.114||95.0|-2.44|0.26|||Mixed Models Analysis||||
1759911|NCT00174382|3231665|Superiority or Other||Mean Difference (Net)|-0.83|Standard Error of the Mean|0.62||0.182||95.0|-2.06|0.39|||Mixed Models Analysis||||
1759912|NCT00174382|3231666|Superiority or Other|||||||0.018|||||||Mixed Models Analysis||||
1759913|NCT00174382|3231666|Superiority or Other||Mean Difference (Net)|-1.12|Standard Error of the Mean|0.47||0.018||95.0|-2.05|-0.19|||Mixed Models Analysis||||
1759914|NCT00174382|3231666|Superiority or Other||Mean Difference (Net)|-1.1|Standard Error of the Mean|0.42||0.01||95.0|-1.93|-0.27|||Mixed Models Analysis||||
1759915|NCT00174382|3231667|Superiority or Other|||||||0.004|||||||Mixed Models Analysis||||
1759916|NCT00174382|3231667|Superiority or Other||Median Difference (Net)|0.87|Standard Error of the Mean|0.36||0.018||95.0|0.16|1.59|||Mixed Models Analysis||||
1759917|NCT00174382|3231667|Superiority or Other||Median Difference (Net)|0.79|Standard Error of the Mean|0.33||0.02||95.0|0.13|1.45|||Mixed Models Analysis||||
1759918|NCT00174382|3231668|Superiority or Other|||||||0.133|||||||Mixed Models Analysis||||
1759919|NCT00174382|3231668|Superiority or Other||Mean Difference (Net)|-0.34|Standard Error of the Mean|0.32||0.297||95.0|-0.97|0.3|||Mixed Models Analysis||||
1759920|NCT00174382|3231668|Superiority or Other||Mean Difference (Net)|0.21|Standard Error of the Mean|0.33||0.516||95.0|-0.44|0.86|||Mixed Models Analysis||||
1759921|NCT00174382|3231669|Superiority or Other|||||||0.06|||||||Mixed Models Analysis||||
1759922|NCT00174382|3231669|Superiority or Other||Mean Difference (Net)|0.72|Standard Error of the Mean|0.33||0.03||95.0|0.07|1.37|||Mixed Models Analysis||||
1759923|NCT00174382|3231669|Superiority or Other||Mean Difference (Net)|0.32|Standard Error of the Mean|0.35||0.368||95.0|-0.38|1.01|||Mixed Models Analysis||||
1759924|NCT00174382|3231670|Superiority or Other|||||||0.007|||||||Mixed Models Analysis||||
1759925|NCT00174382|3231670|Superiority or Other||Median Difference (Net)|1.0|Standard Error of the Mean|0.36||0.006||95.0|0.29|1.71|||Mixed Models Analysis||||
1759926|NCT00174382|3231670|Superiority or Other||Mean Difference (Net)|0.13|Standard Error of the Mean|0.35||0.719||95.0|-0.56|0.82|||Mixed Models Analysis||||
1759927|NCT00174382|3231671|Superiority or Other|||||||0.906|||||||Mixed Models Analysis||||
1759928|NCT00174382|3231671|Superiority or Other||Mean Difference (Net)|-0.27|Standard Error of the Mean|2.0||0.894||95.0|-4.21|3.68|||Mixed Models Analysis||||
1759929|NCT00174382|3231671|Superiority or Other||Mean Difference (Net)|1.78|Standard Error of the Mean|1.61||0.272||95.0|-1.42|4.99|||Mixed Models Analysis||||
1759930|NCT00174382|3231672|Superiority or Other|||||||0.494|||||||Mixed Models Analysis||||
1759931|NCT00174382|3231672|Superiority or Other||Mean Difference (Net)|0.57|Standard Error of the Mean|2.56||0.826||95.0|-4.51|5.64|||Mixed Models Analysis||||
1759932|NCT00174382|3231672|Superiority or Other||Mean Difference (Net)|1.84|Standard Error of the Mean|2.19||0.404||95.0|-2.51|6.18|||Mixed Models Analysis||||
1759933|NCT00174382|3231673|Superiority or Other|||||||0.228|||||||Mixed Models Analysis||||
1759936|NCT00174382|3231674|Superiority or Other|||||||0.085|||||||Mixed Models Analysis|||Week 24 LOCF Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.|
1759937|NCT00174382|3231674|Superiority or Other||Mean Difference (Net)|0.66|Standard Error of the Mean|0.36||0.067||95.0|-0.05|1.36|||Mixed Models Analysis|||Week 24 Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.|
1759938|NCT00174382|3231674|Superiority or Other||Mean Difference (Net)|0.44|Standard Error of the Mean|0.33||0.182||95.0|-0.21|1.09||Baseline value, center, and week as fixed effects; subject was included as a random effect.|Mixed Models Analysis|||Week 12 Null hypothesis; change from baseline to the final visit = 0. Alternative hypothesis; change from baseline to final visit not = to 0. Sample of 260 participants was required for study to have 85% power to detect change from baseline to final visit of 0.73 in SMMSE total score, with a SD of 3.5. Fewer than 260 patients were enrolled, due to this loss in power the number of analyses specified in the protocol has been reduced and any analyses carried out will be exploratory in nature.|
1759939|NCT00174265|3231687|Superiority or Other|||||||0.81||||||Significant level adjusted for one interim analysis was set as 0.049 two-sided.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from Baseline in QLS total score between asenapine and olanzapine at Week 52.|
1759940|NCT00174265|3231688|Superiority or Other|||||||0.0148||||||The test of hypothesis was a 2-tailed test with alpha=0.05 (0.049 to adjust for one interim analysis).|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from Baseline in NSA Scale total score between asenapine and olanzapine at Day 365.|
1759941|NCT00174252|3231696|Superiority or Other||Mean Difference (Net)|-0.59||||0.325||95.0|||||ANCOVA|Adjusted for height SD at baseline.|||
1759942|NCT00174252|3231697|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.708||95.0|||||ANCOVA|Adjusted for height SD at baseline.|||
1759943|NCT00174252|3231698|Superiority or Other||Mean Difference (Net)|-0.35||||0.023||95.0||||Bilateral test multiple comparison threshold for statistical significance = 0.05|ANCOVA|Adjusted for height SD at baseline.|||
1759944|NCT00174252|3231699|Superiority or Other||Mean Difference (Net)|-0.35||||0.002||95.0|||||ANCOVA|Adjusted for height SD at baseline.|||
1759945|NCT00174252|3231713|Superiority or Other||Percentage|14.0||||||95.0|6.3|25.8|||||95% confidence interval (CI) was estimated using the F-distribution.|"Applies to yes."|
1759946|NCT00174252|3231713|Superiority or Other||Percentage|86.0|||||2-Sided|95.0|74.2|93.7|||||95% CI was estimated using the F-distribution.|"Applies to no."|
1759947|NCT00170846|3231824|Superiority or Other||Difference in LS means|0.5933||||0.7943|2-Sided|95.0|-3.8815|5.0682|||ANCOVA||||
1759948|NCT00170846|3231824|Superiority or Other||Difference in LS means|1.1241||||0.6332|2-Sided|95.0|-3.5077|5.7559|||ANCOVA||||
1759949|NCT00170625|3231826|Superiority or Other||number of patients with adverse events|26.0|||||2-Sided||||||||||
1759950|NCT00169104|3231861|Superiority||Mean Difference (Net)|-0.2|||>|0.05|2-Sided|||||t=-0.29|t-test, 2 sided|df=15||T test|
1759951|NCT00168844|3231867|Superiority or Other||Mean Difference (Final Values)|-0.9|Standard Error of the Mean|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48|
1759952|NCT00168844|3231867|Superiority or Other||Mean Difference (Final Values)|-0.8|Standard Error of the Mean|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48|
1759953|NCT00168844|3231868|Superiority or Other||Mean Difference (Final Values)|35.5|Standard Error of the Mean|5.6|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48|
1759954|NCT00168844|3231868|Superiority or Other||Mean Difference (Final Values)|25.5|Standard Error of the Mean|5.6|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48|
1759955|NCT00168844|3231869|Superiority or Other||Mean Difference (Final Values)|33.1|Standard Error of the Mean|5.3|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48|
1759956|NCT00168844|3231869|Superiority or Other||Mean Difference (Final Values)|22.5|Standard Error of the Mean|5.3|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48|
1759957|NCT00168844|3231870|Superiority or Other||Mean Difference (Final Values)|0.419|Standard Error of the Mean|0.041|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48|
1759958|NCT00168844|3231870|Superiority or Other||Mean Difference (Final Values)|0.31|Standard Error of the Mean|0.041|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48|
1759959|NCT00168844|3231871|Superiority or Other||Mean Difference (Final Values)|0.234|Standard Error of the Mean|0.021|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48|
1759960|NCT00168844|3231871|Superiority or Other||Mean Difference (Final Values)|0.22|Standard Error of the Mean|0.021|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48|
1760047|NCT00167778|3232073|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.05.|Mixed Models Analysis||||
1759961|NCT00168844|3231872|Superiority or Other||Mean Difference (Final Values)|0.323|Standard Error of the Mean|0.039|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48|
1759962|NCT00168844|3231872|Superiority or Other||Mean Difference (Final Values)|0.178|Standard Error of the Mean|0.039|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48|
1759963|NCT00168844|3231916|Superiority or Other||Odds Ratio (OR)|0.725|||<|0.0001|2-Sided|95.0|0.635|0.828|||Poisson regression||Tiotropium Respimat 10mcg - Placebo||
1759964|NCT00168844|3231916|Superiority or Other||Odds Ratio (OR)|0.782|||<|0.0002|2-Sided|95.0|0.687|0.89|||Poisson regression||Tiotropium Respimat 5mcg - Placebo||
1759965|NCT00168844|3231917|Superiority or Other||Mean Difference (Final Values)|1.075|Standard Error of the Mean|0.166|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|||
1759966|NCT00168844|3231917|Superiority or Other||Mean Difference (Final Values)|1.053|Standard Error of the Mean|0.165|<|0.0001|2-Sided|95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo||
1759967|NCT00168844|3231918|Superiority or Other||Mean Difference (Final Values)|-4.242|Standard Error of the Mean|0.999|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo||
1759968|NCT00168844|3231918|Superiority or Other||Mean Difference (Final Values)|-3.269|Standard Error of the Mean|0.996|<|0.0011||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo||
1759969|NCT00168844|3231919|Superiority or Other||Mean Difference (Final Values)|0.161|Standard Error of the Mean|0.02|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 10mcg - Placebo||
1759970|NCT00168844|3231919|Superiority or Other||Mean Difference (Final Values)|0.142|Standard Error of the Mean|0.019|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value.|Tiotropium Respimat 5mcg - Placebo||
1759971|NCT00168831|3231925|Superiority or Other||Mean Difference (Final Values)|-0.7|Standard Error of the Mean|0.2|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48|
1759972|NCT00168831|3231925|Superiority or Other||Mean Difference (Final Values)|-0.4|Standard Error of the Mean|0.2|<|0.0169||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48|
1759973|NCT00168831|3231926|Superiority or Other||Mean Difference (Final Values)|39.1|Standard Error of the Mean|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48|
1759974|NCT00168831|3231926|Superiority or Other||Mean Difference (Final Values)|32.0|Standard Error of the Mean|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48|
1759975|NCT00168831|3231927|Superiority or Other||Mean Difference (Final Values)|31.7|Standard Error of the Mean|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48|
1759976|NCT00168831|3231927|Superiority or Other||Mean Difference (Final Values)|27.9|Standard Error of the Mean|4.9|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, centre,smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48|
1759977|NCT00168831|3231928|Superiority or Other||Mean Difference (Final Values)|0.393|Standard Error of the Mean|0.04|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48|
1759978|NCT00168831|3231928|Superiority or Other||Mean Difference (Final Values)|0.369|Standard Error of the Mean|0.04|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48|
1759979|NCT00168831|3231929|Superiority or Other||Mean Difference (Final Values)|0.212|Standard Error of the Mean|0.018|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 10mcg - Placebo|Analysis for week 48|
1759980|NCT00168831|3231929|Superiority or Other||Mean Difference (Final Values)|0.183|Standard Error of the Mean|0.018|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48|
1759981|NCT00168831|3231930|Superiority or Other||Mean Difference (Final Values)|0.252|Standard Error of the Mean|0.037|<|0.0001||95.0|||||ANCOVA||Tiotropium Respimat 10mcg - Placebo|Analysis for week 48|
1759982|NCT00168831|3231930|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|0.037|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value.|Tiotropium Respimat 5mcg - Placebo|Analysis for week 48|
1759983|NCT00168831|3231974|Superiority or Other||Odds Ratio (OR)|0.725|||<|0.0001|2-Sided|95.0|0.635|0.828|||Poisson regression||Tiotropium Respimat 10mcg vs. Placebo||
1759984|NCT00168831|3231974|Superiority or Other||Odds Ratio (OR)|0.782|||<|0.0002|2-Sided|95.0|0.687|0.89|||Poisson regression||Tiotropium Respimat 5mcg vs. Placebo||
1759985|NCT00168831|3231975|Superiority or Other||Mean Difference (Final Values)|1.075|Standard Error of the Mean|0.166|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo||
1759986|NCT00168831|3231975|Superiority or Other||Mean Difference (Final Values)|1.053|Standard Error of the Mean|0.165|<|0.0001||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo||
1759987|NCT00168831|3231976|Superiority or Other||Mean Difference (Final Values)|-3.445|Standard Error of the Mean|1.059||0.0012||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 10mcg - Placebo||
1760091|NCT00163293|3232214|Superiority or Other|||||||0.6844|||||||Kruskal-Wallis||||
1759988|NCT00168831|3231976|Superiority or Other||Mean Difference (Final Values)|-3.713|Standard Error of the Mean|1.052||0.0004||95.0|||||ANCOVA|The means are adjusted for centre, smoking status at entry and baseline value.|Tiotropium Respimat 5mcg - Placebo||
1759989|NCT00168831|3231977|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.017|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry,centre and baseline value|Tiotropium Respimat 10mcg - Placebo||
1759990|NCT00168831|3231977|Superiority or Other||Mean Difference (Final Values)|0.113|Standard Error of the Mean|0.017|<|0.0001||95.0|||||ANCOVA|ANCOVA analysis with terms for treatment, smoking status at entry, centre and baseline value|Tiotropium Respimat 5mcg - Placebo||
1759991|NCT00168818|3231981|Superiority or Other|||||||0.6037|||||||Fisher Exact|||Comparison versus Enoxaparin|
1759992|NCT00168818|3231981|Superiority or Other|||||||0.4352|||||||Fisher Exact|||Comparison versus Enoxaparin|
1759993|NCT00168818|3231983|Superiority or Other|||||||0.2497|||||||Fisher Exact|||Comparison versus Enoxaparin|
1759994|NCT00168818|3231983|Superiority or Other|||||||0.124|||||||Fisher Exact|||Comparison versus Enoxaparin|
1759995|NCT00168818|3231984|Superiority or Other|||||||0.3717|||||||Fisher Exact|||Comparison versus Enoxaparin|
1759996|NCT00168818|3231984|Superiority or Other|||||||0.5062|||||||Fisher Exact|||Comparison versus Enoxaparin|
1759997|NCT00168818|3231985|Superiority or Other|||||||0.0212|||||||Fisher Exact|||Comparison versus Enoxaparin|
1759998|NCT00168818|3231985|Superiority or Other|||||||0.0694|||||||Fisher Exact|||Comparison versus Enoxaparin|
1759999|NCT00168818|3231986|Superiority or Other||Risk Difference (Percentage)|1.9||||0.1274||95.0|-0.5|4.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760000|NCT00168818|3231986|Superiority or Other||Risk Difference (Percentage)|-1.1||||0.3173||95.0|-3.3|1.1|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760001|NCT00168818|3231987|Superiority or Other||Risk Difference (Percentage)|0.3||||0.702||95.0|-1.4|2.1|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760002|NCT00168818|3231987|Superiority or Other||Risk Difference (Percentage)|-1.1||||0.1863||95.0|-2.7|0.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760003|NCT00168818|3231988|Superiority or Other||Risk Difference (Percentage)|0.4||||0.7052||95.0|-1.5|2.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760004|NCT00168818|3231988|Superiority or Other||Risk Difference (Percentage)|-0.8||||0.3256||95.0|-2.5|0.8|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760005|NCT00168818|3231989|Non-Inferiority or Equivalence|Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|1.9||||0.1339||95.0|-0.6|4.4||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760006|NCT00168818|3231989|Non-Inferiority or Equivalence|Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|-0.7||||0.5648||95.0|-2.9|1.6||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760007|NCT00168805|3231993|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760008|NCT00168805|3231993|Superiority or Other|||||||0.8209|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760009|NCT00168805|3231995|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760010|NCT00168805|3231995|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760011|NCT00168805|3231996|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760012|NCT00168805|3231996|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760013|NCT00168805|3231997|Superiority or Other|||||||0.1414|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760014|NCT00168805|3231997|Superiority or Other|||||||0.0385|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760015|NCT00168805|3231998|Superiority or Other||Risk Difference (Percentage)|2.7||||0.374||95.0|-3.2|8.6|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760016|NCT00168805|3231998|Superiority or Other||Risk Difference (Percentage)|-1.4||||0.6463||95.0|-7.3|4.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760017|NCT00168805|3231999|Superiority or Other||Risk Difference (Percentage)|0.1||||0.9325||95.0|-2.1|2.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760018|NCT00168805|3231999|Superiority or Other||Risk Difference (Percentage)|-0.8||||0.4715||95.0|-2.8|1.3|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760019|NCT00168805|3232000|Superiority or Other||Risk Difference (Percentage)|0.3||||0.8151||95.0|-2.0|2.6|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760020|NCT00168805|3232000|Superiority or Other||Risk Difference (Percentage)|-1.0||||0.376||95.0|-3.1|1.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760048|NCT00167778|3232075|Superiority or Other||||||>|0.99||||||Statistical significance was set a-prior at p<0.05.|Mixed Models Analysis||||
1760049|NCT00167778|3232076|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.05.|Mixed Models Analysis||||
1760050|NCT00167778|3232077|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.05.|Mixed Models Analysis||||
1760021|NCT00168805|3232001|Non-Inferiority or Equivalence|Non-inferiority Analysis with NI margin 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|2.8||||0.3553||95.0|-3.1|8.7||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760022|NCT00168805|3232001|Non-Inferiority or Equivalence|Non-inferiority Analysis with NI margin 9.2%. This results from the null-hypotheses of non-inferiority testing, where the absolute risk difference has to be below 9.2%. Non-inferiority can only be shown with CI.|Risk Difference (Percentage)|-1.3||||0.6648||95.0|-7.3|4.6||p-value is for superiority testing|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760023|NCT00168103|3232038|Superiority or Other|||||||0.0329||||||1-sided P-value. The a priori threshold for significance was 0.1 (trend).|Wilcoxon (Mann-Whitney)|1-sided|||
1760024|NCT00168103|3232039|Superiority or Other||Odds Ratio (OR)|0.1714|||||2-Sided|95.0|0.0642|0.4575|||||The Odds Ratio was calculated as C1-INH 20 U/kg bw (numerator) versus Placebo (denominator).|This was an exploratory analysis.|
1760025|NCT00168103|3232040|Superiority or Other||Median Difference (Final Values)|-3.292||||0.0237|2-Sided|80.0|-5.15|-1.05||1-sided, exploratory test.|Wilcoxon (Mann-Whitney)|1-sided|The median difference was estimated by the Hodge-Lehmann estimate.|This was an exploratory analysis.|
1760026|NCT00168103|3232041|Superiority or Other||Odds Ratio (OR)|0.1088||||0.0014|2-Sided|80.0|0.0392|0.3023||1-sided P-value. The a priori threshold for significance was 0.1 (trend).|Fisher Exact|1-sided|The Odds Ratio was calculated as C1-INH 20 U/kg bw (numerator) versus Placebo (denominator).|Worsened intensity was evaluated between 2 and 4 hours after start of study treatment relative to baseline for at least 1 of the HAE symptoms present at baseline.|
1760027|NCT00168103|3232042|Superiority or Other||Median Difference (Final Values)|-0.525||||0.0025|2-Sided|95.0|-2.217|-0.033||1-sided P-value. The a priori threshold was 0.024 (overall Type 1 error 0.025 adjusted for alpha spending for an interim analysis).|Wilcoxon (Mann-Whitney)|1-sided|The median difference was estimated by the Hodges-Lehmann estimate.||
1760028|NCT00168064|3232045|Non-Inferiority or Equivalence|The PG formulation was determined to be non-inferior to the AP formulation if the lower limit of the 95% confidence interval around the ratio of the response rates (PG/AP) was > = 0.75.|ratio of proportions|1.226|||||2-Sided|95.0|0.974|1.552|||||ratio is response rate of PG formulation divided by response rate of AP formulation||
1760029|NCT00167934|3232055|Superiority or Other (legacy)|||||||0.04|||||||ANCOVA||||
1760030|NCT00167934|3232056|Superiority or Other (legacy)||||||<|0.0001|||||||ANCOVA||||
1760031|NCT00167778|3232057|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.|||
1760032|NCT00167778|3232058|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.|||
1760033|NCT00167778|3232059|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.|||
1760034|NCT00167778|3232060|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.|||
1760035|NCT00167778|3232061|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.|||
1760036|NCT00167778|3232062|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.1.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between the Rigid and Torsion Adapter pylons.|||
1760037|NCT00167778|3232063|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.05.|Wilcoxon (Mann-Whitney)|Wilcoxon paired signed rank test for the differences between Rigid and Torsion Adapter pylons.|||
1760038|NCT00167778|3232064|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.05.|Wilcoxon (Mann-Whitney)|Wilcoon paired signed rank test for the differences between Rigid and Torsion Adapter pylons|||
1760039|NCT00167778|3232065|Superiority or Other||||||>|0.15||||||Statistical significance was set a-prior at p<0.05. Values of p>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.|||
1760040|NCT00167778|3232066|Superiority or Other||||||>|0.15||||||Statistical significance was set a-prior at p<0.05. Values of p>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.|||
1760041|NCT00167778|3232067|Superiority or Other||||||>|0.15||||||Statistical significance was set a-prior at p<0.05. Values of p>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.|||
1760042|NCT00167778|3232068|Superiority or Other||||||>|0.15||||||Statistical significance was set a-prior at p<0.05. Values of p>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.|||
1760043|NCT00167778|3232069|Superiority or Other||||||>|0.15||||||Statistical significance was set a-prior at p<0.05. Values of p>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.|||
1760044|NCT00167778|3232070|Superiority or Other||||||>|0.15||||||Statistical significance was set a-prior at p<0.05. Values of p>0.15 were considered not significant (NS) statistically.|Mixed Models Analysis|The effect of study prosthesis was analyzed using repeated measures one-way analyses of variance.|||
1760045|NCT00167778|3232071|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.05.|Mixed Models Analysis||||
1760046|NCT00167778|3232072|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.05.|Mixed Models Analysis||||
1760089|NCT00165698|3232188|Superiority or Other|||||||0.19|||||||Symbols rank sum test||||
1760051|NCT00167778|3232078|Superiority or Other||||||=|0||||||Statistical significance was set a-prior at p<0.05.|Mixed Models Analysis||||
1760052|NCT00167778|3232079|Superiority or Other||||||>|0.99||||||Statistical significance was set a-prior at p<0.05.|Mixed Models Analysis||||
1760053|NCT00167544|3232083|Superiority or Other||Mean Difference (Final Values)|5.4|||<|0.05|2-Sided|95.0|-19.49|30.29|||ANCOVA|||The primary analysis of total brain tissue volume was performed using multiple linear regression controlling for postmenstrual age at MRI scan to adjust for differences in timing at MRI. The distributions of potentially important confounding variables at baseline were compared in the two groups using parametric and non-parametric tests as appropriate. All analyses were performed using STATA 11.0. Please see PubMed: 23140612.|
1760054|NCT00167388|3232090|Superiority or Other|||||||0.286|||||||Wilcoxon (Mann-Whitney)|||Change in peak systolic mesenteric blood flow velocity from pre-to post-feed for babies >1250 gm after the PRBC transfusion|
1760055|NCT00167388|3232090|Superiority or Other|||||||0.507|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre-to post-feed for babies >1250 gm after the PRBC transfusion|
1760056|NCT00167388|3232090|Superiority or Other|||||||0.85|||||||Wilcoxon (Mann-Whitney)|||Change in Peak systolic mesenteric blood flow velocity from pre-to post-feed for babies <1250 gm after the PRBC transfusion|
1760057|NCT00167388|3232090|Superiority or Other|||||||0.91|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre-to post-feed for babies <1250 gm after the PRBC transfusion|
1760058|NCT00167388|3232090|Superiority or Other|||||||0.035|||||||Wilcoxon (Mann-Whitney)|||change in peak systolic blood flow velocity from pre-to post feed for babies >1250 gm while anemic|
1760059|NCT00167388|3232090|Superiority or Other|||||||0.006|||||||Wilcoxon (Mann-Whitney)|||Change in superior mesenteric artery blood flow velocity from pre- to post- feed in the anemic state for babies >1250 gm|
1760060|NCT00167388|3232090|Superiority or Other|||||||0.345|||||||Wilcoxon (Mann-Whitney)|||change in peak systolic blood flow velocity from pre-to post feed for babies <1250 gm while anemic|
1760061|NCT00167388|3232090|Superiority or Other|||||||0.571|||||||Wilcoxon (Mann-Whitney)|||Change in mean mesenteric blood flow velocity from pre- to post- feed in the anemic state for babies <1250 gm|
1760062|NCT00167245|3232097|Superiority or Other|||||||0.45|||||||Generalized Estimating Equations||||
1760063|NCT00167245|3232098|Superiority or Other|||||||0.01|||||||Chi-squared||||
1760064|NCT00166517|3232121|Non-Inferiority or Equivalence|Non-inferiority was assessed versus a constant, 85%, based on historical data.||||||0.003||||||p ≥.85, where p is the proportion of subjects who achieved ≥3-fold rise from baseline in the group that received RotaTeq®|Exact test of proportion|Exact test of proportion, based on binomial distribution|||
1760065|NCT00166504|3232122|Superiority or Other||Mean Difference (Net)|-10.0|Standard Deviation|15.3|<|0.001||95.0|-14.3|-5.7|||ANOVA||Direction of the Comparison: Vytorin minus Atorvastatin.||
1760066|NCT00166296|3232127|Superiority or Other|||||||0.93|||||||ANOVA||||
1760067|NCT00166296|3232128|Superiority or Other|||||||0.443|||||||ANOVA||||
1760068|NCT00166296|3232129|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1760069|NCT00166296|3232130|Superiority or Other||Odds Ratio (OR)|0.4||||0.441|2-Sided|95.0|0.075|2.141|||Fisher Exact||||
1760070|NCT00166205|3232131|Superiority or Other||Mean|193.5|Standard Deviation|36.9||||95.0|188.6|198.4|||||||
1760071|NCT00166205|3232132|Superiority or Other||Mean|114.5|Standard Deviation|32.3||||95.0|110.1|118.8|||||||
1760072|NCT00166205|3232133|Superiority or Other||Mean|56.4|Standard Deviation|14.7||||95.0|54.5|58.4|||||||
1760073|NCT00166205|3232134|Superiority or Other||||||<|0.001|||||||t-test, 1 sided|||A one-sided paired t-test would have 80% power to reject the null hypothesis in favor of the alternative (i.e., that the SAGB system is not inferior to the clinically meaningful result of 36.2 for 224 subjects) assuming: a standard deviation (SD) of (21.6), an equivalent limit difference of (3.6), and a significance level of 0.05.|
1760074|NCT00166205|3232136|Superiority or Other||Mean|5.7|Standard Deviation|0.7||||95.0|5.6|5.8|||||||
1760075|NCT00166205|3232137|Superiority or Other||Mean Difference (Net)|10.4|Standard Deviation|10.3||||95.0|9.2|11.7|||||Value at 36 months minus value at baseline. Positive values indicate improved Quality of Life (QOL)||
1760076|NCT00166205|3232138|Superiority or Other||Mean|51.3|Standard Deviation|45.8||||95.0|47.6|54.9|||||||
1760077|NCT00166205|3232139|Superiority or Other||Mean|35.7|Standard Deviation|6.2||||95.0|34.9|36.5|||||||
1760078|NCT00166205|3232140|Superiority or Other||Mean|75.7|Standard Deviation|39.8||||95.0|70.5|80.8|||||||
1760079|NCT00166205|3232141|Superiority or Other||Percent of ITT subjects|69.6||||||95.0|63.8|74.9||||||A sample size of 215, the adverse event (AE) rate at three years could be estimated with precision as determined by the interval half-width of approximately ± 7%.|
1760080|NCT00166114|3232153|Superiority or Other|||||||0.918|||||||Chi-squared|||Chi Square test was performed comparing actual vs. expected non- and partial response or response to either escitalopram or desipramine treatment.|
1760081|NCT00165984|3232156|Superiority or Other||Odds Ratio (OR)|4.9||||0.003|2-Sided|95.0|1.7|13.9|||Regression, Cox||||
1760082|NCT00165841|3232161|Superiority or Other||||||<|0.0001||||||p-value was adjusted for multiple comparisons.|t-test, 2 sided|The primary analysis was on the ITT population using all observed data collected from Day 1 of the maintenance phase until the endpoint.||Efficacy analyses were based on the intent-to-treat (ITT) population, which was comprised of all patients in the safety-evaluable population who had a baseline and ≥1 post-randomization primary efficacy endpoint evaluation and who had received ≥1 dose of study medication during the maintenance phase.|
1760083|NCT00165698|3232182|Superiority or Other|||||||0|||||||symbols rank sum test||||
1760084|NCT00165698|3232183|Superiority or Other|||||||0|||||||symbols rank sum test||||
1760085|NCT00165698|3232184|Superiority or Other|||||||0|||||||symbols rank sum test||||
1760086|NCT00165698|3232185|Superiority or Other|||||||0.174|||||||symbols rank sum test||||
1760087|NCT00165698|3232186|Superiority or Other|||||||0.869|||||||symbols rank sum test||||
1760088|NCT00165698|3232187|Superiority or Other|||||||0.31|||||||Symbols rank sum test||||
1760092|NCT00163293|3232214|Superiority or Other|||||||0.4754|||||||Kruskal-Wallis||||
1760093|NCT00163293|3232216|Superiority or Other|||||||0.0145|||||||Wald Chi-square|zero inflated Poisson model: adjustment for centre and age [yrs] (zero model), treatment and race (Poisson model)|||
1760094|NCT00163293|3232216|Superiority or Other|||||||0.1291|||||||Wald Chi-square|zero inflated Poisson model: adjustment for centre and age [yrs] (zero model), treatment and race (Poisson model)|||
1760095|NCT00163293|3232217|Superiority or Other|||||||0.7303|||||||Log Rank||||
1760096|NCT00163293|3232217|Superiority or Other|||||||0.6625|||||||Log Rank||||
1760097|NCT00163189|3232252|Superiority or Other|||||||0.008|||||||Student’s paired t-test|||Month 36|
1760098|NCT00163189|3232253|Superiority or Other||||||<|0.001|||||||Student’s paired t-test|||Month 36|
1760099|NCT00162981|3232272|Non-Inferiority or Equivalence|Assuming a standard deviation of 50%, one-tailed significance at 0.05 and a power of 80% to detect a reduction of at least 25% (baseline to final in a within-subjects design), then approximately 27 subjects would have been required in each treatment arm. Assuming a 10% drop-out rate, then approximately 30 subjects per treatment were to be enrolled in the study.|||||<|0.0001|||||||1-sided Wilcoxon Rank-Sum Test|1-sided Wilcoxon Rank-Sum Test was used to compare the high dose group to the low dose group.|||
1760100|NCT00162981|3232275|Superiority or Other|||||||0.0001||||||1-sided Wilcoxon signed rank test was used to assess the difference from baseline.|1-sided Wilcoxon signed rank test||||
1760101|NCT00162981|3232275|Superiority or Other||||||<|0.0182|||||||1-sided Wilcoxon signed rank test|1-sided Wilcoxon signed rank test was used to assess the difference from baseline.|||
1760102|NCT00162942|3232276|Superiority or Other|||||||0.8618|||||||Fisher Exact||||
1760103|NCT00162942|3232277|Superiority or Other|||||||0.0289|||||||Fisher Exact||||
1760104|NCT00162942|3232278|Superiority or Other|||||||0.8721|||||||Fisher Exact||||
1760105|NCT00162942|3232279|Superiority or Other|||||||0.0506|||||||Fisher Exact (Mid-P-Value)||||
1760106|NCT00162942|3232279|Superiority or Other|||||||0.0676|||||||Fisher Exact||||
1760107|NCT00162942|3232280|Superiority or Other|||||||0.8265|||||||Fisher Exact||||
1760108|NCT00162942|3232281|Superiority or Other|||||||0.0504|||||||Fisher Exact (Mid-P-Value)||||
1760109|NCT00162942|3232281|Superiority or Other|||||||0.0632|||||||Fisher Exact||||
1760110|NCT00162942|3232282|Superiority or Other|||||||0.35|||||||Wilcoxon (Mann-Whitney)||||
1760111|NCT00162942|3232283|Superiority or Other|||||||0.87|||||||Wilcoxon (Mann-Whitney)||||
1760112|NCT00162942|3232284|Superiority or Other|||||||0.256|||||||Wilcoxon (Mann-Whitney)||||
1760113|NCT00162942|3232285|Superiority or Other|||||||0.222|||||||Wilcoxon (Mann-Whitney)||||
1760114|NCT00162942|3232286|Superiority or Other|||||||0.759|||||||Wilcoxon (Mann-Whitney)||||
1760115|NCT00162942|3232287|Superiority or Other|||||||0.441|||||||Wilcoxon (Mann-Whitney)||||
1760116|NCT00162942|3232288|Superiority or Other|||||||0.379|||||||Wilcoxon (Mann-Whitney)||||
1760117|NCT00162942|3232289|Superiority or Other|||||||0.261|||||||Wilcoxon (Mann-Whitney)||||
1760118|NCT00162942|3232290|Superiority or Other|||||||0.0773|||||||Wilcoxon (Mann-Whitney)||||
1760119|NCT00162942|3232291|Superiority or Other|||||||0.17|||||||Wilcoxon (Mann-Whitney)||||
1760120|NCT00162942|3232292|Superiority or Other|||||||0.67|||||||Wilcoxon (Mann-Whitney)||||
1760121|NCT00162942|3232293|Superiority or Other|||||||0.977|||||||Wilcoxon (Mann-Whitney)||||
1760122|NCT00162942|3232294|Superiority or Other|||||||0.67|||||||Student's t-test||||
1760123|NCT00162942|3232295|Superiority or Other|||||||1|||||||Fisher Exact||||
1760124|NCT00162942|3232296|Superiority or Other|||||||0.813|||||||Student's t-test||||
1760125|NCT00162942|3232298|Superiority or Other|||||||0.858|||||||Fisher Exact||||
1760126|NCT00162370|3232304|Superiority or Other||||||<|0.0001|||||||Regression, Cox||||
1760127|NCT00162370|3232305|Superiority or Other|||||||0.014|||||||Regression, Cox|||The null hypothesis evaluated is that the scores are not associated with outcome. Of the two measures, wall motion index is considered to be the primary endpoint measure. The cardiac event rate will be summarized by categorical levels of wall motion index score and the difference in wall motion index score.|
1760128|NCT00162266|3232364|Superiority or Other||Mean Difference (Final Values)|12.48||||0.0869|2-Sided|95.0|-1.82|26.78|||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 360|
1760129|NCT00162266|3232364|Superiority or Other||Mean Difference (Final Values)|32.24||||0.0001|2-Sided|95.0|16.14|48.33|||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 360|
1760130|NCT00162266|3232364|Superiority or Other||Mean Difference (Final Values)|7.68||||0.3253|2-Sided|95.0|||||ANCOVA|ANCOVA model: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 180|
1760131|NCT00162266|3232364|Superiority or Other||Mean Difference (Final Values)|27.66||||0.0003|2-Sided|95.0|12.67|42.66|||ANCOVA|ANCOVA: % change = pretreatment|Estimate = adjusted % change (BMS10mg/kg+MTX or BMS 2mg/kg+MTX) - adjusted change for placebo+MTX|Day 180|
1760132|NCT00162266|3232368|Superiority or Other||Mean Difference (Final Values)|1054.38||||0.3029|2-Sided|95.0|-955.59|3064.35||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 360|
1760133|NCT00162266|3232368|Superiority or Other||Mean Difference (Final Values)|5641.6||||0.0001|2-Sided|95.0|2823.46|8459.74||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 360|
1760134|NCT00162266|3232368|Superiority or Other||Mean Difference (Final Values)|353.47||||0.4393|2-Sided|95.0|-544.46|1251.41||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 180|
1760135|NCT00162266|3232368|Superiority or Other||Mean Difference (Final Values)|2132.63||||0.0001|2-Sided|95.0|1067.32|3197.94||ANOVA model: AUC = treatment|ANOVA||Estimate = Model AUC for Aripiprazole+MTX - Model AUC for PLACEBO+MTX|Comparison at Day 180|
1760390|NCT00153101|3232900|Superiority or Other||Hazard Ratio (HR)|1.03||||0.515||95.0|0.95|1.11|||Regression, Cox||||
1760136|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|4.06||||0.2989|2-Sided|95.0|-3.61|11.72|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 360 Treatment Comparison|
1760137|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|20.38||||0.0001|2-Sided|95.0|10.2|30.56|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 360 Treatment Comparison|
1760138|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|3.13||||3.13|2-Sided|95.0|-4.15|10.41|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 300 Treatment Comparison|
1760139|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|21.0||||0.0001|2-Sided|95.0|10.51|31.48|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 300 Treatment Comparison|
1760140|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|2.78||||0.4669|2-Sided|95.0|-4.73|10.28|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 240 Treatment Comparison|
1760141|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|17.63||||0.0001|2-Sided|95.0|8.83|26.44|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 240 Treatment Comparison|
1760142|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|7.38||||0.0451|2-Sided|95.0|0.16|14.6|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 180 Treatment Comparison|
1760143|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|20.36||||0.0001|2-Sided|95.0|10.19|30.54|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 180 Treatment Comparison|
1760144|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|3.32||||0.3552|2-Sided|95.0|-3.73|10.37|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 150 Treatment Comparison|
1760145|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|16.96||||0.0001|2-Sided|95.0|8.49|25.43|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 150 Treatment Comparison|
1760146|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|3.6||||0.3141|2-Sided|95.0|-3.43|10.64|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 120 Treatment Comparison|
1760147|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|14.54||||0.0001|2-Sided|95.0|7.28|21.81|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 120 Treatment Comparison|
1760148|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|4.19||||0.0003|2-Sided|95.0|-2.44|10.81|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 90 Treatment Comparison|
1760149|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|12.1||||0.0003|2-Sided|95.0|5.63|18.56|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 90 Treatment Comparison|
1760150|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|0.6||||0.8495|2-Sided|95.0|-5.62|6.82|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 60 Treatment Comparison|
1760151|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|11.75||||0.0002|2-Sided|95.0|5.67|17.84|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 60 Treatment Comparison|
1760152|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|-1.14||||0.6713|2-Sided|95.0|-6.45|4.16||ANOVA model: AUC = treatment|ANOVA||Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 30 Treatment Comparison|
1760153|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|7.25||||0.0061|2-Sided|95.0|2.08|12.41|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 30 Treatment Comparison|
1760154|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|-3.8||||0.0418|2-Sided|95.0|-7.46|-0.14|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 15 Treatment Comparison|
1760155|NCT00162266|3232369|Superiority or Other||Mean Difference (Final Values)|2.02||||0.2676|2-Sided|95.0|-1.56|5.61|||ANOVA|ANOVA model: AUC = treatment|Estimate= Model AUC for abatacept+methotrexate - Model AUC for placebo+methotrexate|Day 15 Treatment Comparison|
1760156|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|4.8||||0.227|2-Sided|95.0|-3.0|12.6|||Chi-squared|||Response on Day 360|
1760157|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|13.3||||0.003|2-Sided|95.0|4.4|22.2|||Chi-squared|||Response on Day 360|
1760158|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|8.0||||0.014|2-Sided|95.0|1.6|14.3|||Chi-squared|||Response on Day 300|
1760159|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|21.0|||<|0.001|2-Sided|95.0|12.4|29.5|||Chi-squared|||Response on Day 300|
1760160|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|3.5|||<|0.292|2-Sided|95.0|-3.0|10.1|||Chi-squared|||Response on Day 240|
1760161|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|13.2|||<|0.002|2-Sided|95.0|5.0|21.4|||Chi-squared|||Response on Day 240|
1760162|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|8.8|||<|0.005|2-Sided|95.0|2.7|14.9|||Chi-squared|||Response on Day 180|
1760163|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|14.8|||<|0.001|2-Sided|95.0|7.5|22.2|||Chi-squared|||Response on Day 180|
1760164|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|2.4|||<|0.395|2-Sided|95.0|-3.1|7.8|||Chi-squared|||Response on Day 150|
1760542|NCT00150592|3233071|Superiority or Other (legacy)|||||||0.02|||||||ANCOVA||||
1760165|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|10.6|||<|0.004|2-Sided|95.0|3.4|17.7|||Chi-squared|||Response on Day 150|
1760166|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|2.4|||<|0.395||95.0|-3.1|7.8|||Chi-squared||||
1760167|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|9.7|||<|0.007|2-Sided|95.0|2.7|16.7|||Chi-squared|||Response on Day 120|
1760168|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|3.9|||<|0.07|2-Sided|95.0|-0.3|8.2|||Chi-squared|||Response on Day 90|
1760169|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|7.9|||<|0.005|2-Sided|95.0|2.4|13.3|||Chi-squared|||Response on Day 90|
1760170|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|3.8|||<|0.032|2-Sided|95.0|0.3|7.3|||Chi-squared|||Response on Day 60|
1760171|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|8.7|||<|0.001|2-Sided|95.0|3.5|13.9|||Chi-squared|||Response on Day 60|
1760172|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|2.9|||<|0.063|2-Sided|95.0|-0.2|5.9|||Chi-squared|||Response on Day 30|
1760173|NCT00162266|3232370|Superiority or Other||Point Estimate of Difference|3.5|||<|0.04||95.0|0.2|6.8|||Chi-squared|||Response on Day 30|
1760174|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|2.7||||0.625|2-Sided|95.0|-8.1|13.5|||Chi-squared|||Response on Day 360|
1760175|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|21.6|||<|0.001|2-Sided|95.0|9.7|33.4|||Chi-squared|||Response on Day 360|
1760176|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|6.8|||<|0.19|2-Sided|95.0|-3.4|16.9|||Chi-squared|||Response on Day 300|
1760177|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|24.0|||<|0.001|2-Sided|95.0|12.6|35.4|||Chi-squared|||Response on Day 300|
1760178|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|0.8|||<|0.885|2-Sided|95.0|-9.8|11.4|||Chi-squared|||Response on Day 240|
1760179|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|15.5|||<|0.008|2-Sided|95.0|4.0|27.0|||Chi-squared|||Response on Day 240|
1760180|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|11.1|||<|0.027|2-Sided|95.0|1.2|20.9|||Chi-squared|||Response on Day 180|
1760181|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|24.8|||<|0.001|2-Sided|95.0|13.8|35.7|||Chi-squared|||Response on Day 180|
1760182|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|1.2|||<|0.813|2-Sided|95.0|-8.6|10.9|||Chi-squared|||Response on Day 150|
1760183|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|20.6|||<|0.001|2-Sided|95.0|9.3|31.8|||Chi-squared|||Response on Day 150|
1760184|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|2.0|||<|0.682|2-Sided|95.0|-7.6|11.7|||Chi-squared|||Response on Day 120|
1760185|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|17.9|||<|0.001|2-Sided|95.0|7.0|28.9|||Chi-squared|||Response on Day 120|
1760186|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|4.5|||<|0.339|2-Sided|95.0|-4.8|13.8|||Chi-squared|||Response on Day 90|
1760187|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|11.7|||<|0.02|2-Sided|95.0|1.8|21.7|||Chi-squared|||Response on Day 90|
1760188|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|-1.8|||<|0.702|2-Sided|95.0|-11.0|7.4|||Chi-squared|||Response on Day 60|
1760189|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|6.6|||<|0.192|2-Sided|95.0|-3.3|16.5|||Chi-squared|||Response on Day 60|
1760190|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|-2.1|||<|0.474|2-Sided|95.0|-7.7|3.6|||Chi-squared|||Response on Day 30|
1760191|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|8.0|||<|0.039|2-Sided|95.0|0.4|15.7|||Chi-squared|||Response on Day 30|
1760192|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|-2.5|||<|0.101|2-Sided|95.0|-5.5|0.5|||Chi-squared|||Response on Day 15|
1760193|NCT00162266|3232371|Superiority or Other||Point Estimate of Difference|-0.8|||<|0.679|2-Sided|95.0|-4.5|2.9|||Chi-squared|||Response on Day 15|
1760194|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|5.8||||0.377|2-Sided|95.0|-7.0|18.6|||Chi-squared|||Response on Day 360|
1760195|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|26.5|||<|0.001|2-Sided|95.0|13.7|39.3|||Chi-squared|||Response on Day 360|
1760196|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|4.6|||<|0.476|2-Sided|95.0|-8.0|17.2|||Chi-squared|||Response on Day 300|
1760197|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|29.0|||<|0.001|2-Sided|95.0|16.2|41.8|||Chi-squared|||Response on Day 300|
1760198|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|5.7|||<|0.384|2-Sided|95.0|-7.1|18.4|||Chi-squared|||Response on Day 240|
1760199|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|27.3|||<|0.001|2-Sided|95.0|14.5|40.1|||Chi-squared|||Response on Day 240|
1760200|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|6.6|||<|0.31||95.0|-6.2|19.4|||Chi-squared|||Response on Day 180|
1760201|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|25.6|||<|0.001|2-Sided|95.0|12.8|38.4|||Chi-squared|||Response on Day 180|
1760202|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|8.5|||<|0.193|2-Sided|95.0|-4.3|21.3|||Chi-squared|||Response on Day 150|
1760203|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|23.0|||<|0.001|2-Sided|95.0|10.2|35.8|||Chi-squared|||Response on Day 150|
1760204|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|6.9|||<|0.292|2-Sided|95.0|-6.0|19.9|||Chi-squared|||Response on Day 120|
1760205|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|23.9|||<|0.001|2-Sided|95.0|11.1|36.7|||Chi-squared|||Response on Day 120|
1760206|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|2.8|||<|0.664|2-Sided|95.0|-9.8|15.4|||Chi-squared|||Response on Day 90|
1760207|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|18.6|||<|0.004|2-Sided|95.0|5.9|31.4|||Chi-squared|||Response on Day 90|
1760208|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|-1.1|||<|0.86|2-Sided|95.0|-13.5|11.3|||Chi-squared|||Response on Day 60|
1760209|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|22.1|||<|0.001|2-Sided|95.0|9.3|34.8|||Chi-squared|||Response on Day 60|
1760210|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|-9.3|||<|0.113|2-Sided|95.0|-20.8|2.2|||Chi-squared|||Response on Day 30|
1760211|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|11.5|||<|0.067|2-Sided|95.0|-0.8|23.8|||Chi-squared|||Response on Day 30|
1760212|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|-11.6|||<|0.015|2-Sided|95.0|-20.9|-2.3|||Chi-squared|||Response on Day 15|
1760213|NCT00162266|3232372|Superiority or Other||Point Estimate of Difference|5.9|||<|0.283|2-Sided|95.0|-4.9|16.7|||Chi-squared|||Response on Day 15|
1760214|NCT00162266|3232373|Superiority or Other||Point Estimate of Difference|6.6||||0.31|2-Sided|95.0|-6.2|19.4|||Chi-squared||||
1760215|NCT00162266|3232373|Superiority or Other||Point Estimate of Difference|25.6|||<|0.001|2-Sided|95.0|12.8|38.4|||Chi-squared||||
1760216|NCT00161616|3232402|Superiority or Other|||||||0.8961|||||||Fisher Exact||||
1760217|NCT00161616|3232403|Superiority or Other|||||||0.7983|||||||Fisher Exact|||Comparison of Healed vs Not healed/No outcome for week 20.|
1760218|NCT00161616|3232403|Superiority or Other|||||||0.0541|||||||Fisher Exact|||Comparison of Healed vs Not healed/No outcome for week 13.|
1760219|NCT00160680|3232456|Superiority or Other||Mean Difference (Final Values)|0.27|||=|0|2-Sided|95.0|-0.96|1.5|||ANCOVA||||
1760220|NCT00160667|3232470|Superiority or Other||Mean Difference (Final Values)|1.48|||=|0|2-Sided|95.0|-11.69|14.65|||ANCOVA||Estimated value is the difference of Least Square Means.||
1760221|NCT00160667|3232470|Superiority or Other||Mean Difference (Final Values)|0.29|||=|0|2-Sided|95.0|-12.82|13.41|||ANCOVA||Estimated value is the difference of Least Square Means.||
1760222|NCT00159965|3232536|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1760223|NCT00159965|3232537|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1760224|NCT00159965|3232538|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1760225|NCT00159965|3232539|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1760226|NCT00159965|3232540|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1760227|NCT00159965|3232541|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1760228|NCT00159965|3232542|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1760229|NCT00159965|3232543|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1760230|NCT00159965|3232544|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1760231|NCT00159965|3232545|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1760232|NCT00159965|3232546|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1760233|NCT00159965|3232547|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1760234|NCT00159965|3232548|Superiority or Other||||||>|0.05|||||||ANCOVA||||
1760235|NCT00159965|3232549|Superiority or Other||Risk Ratio, log|0.077|Standard Error of the Mean|0.252||0.78|2-Sided|95.0|-0.431|0.571|||Overdispersed Poisson Regression|||Within-group seizure change. The hypothesis is that patients treated with placebo will not show a significant decrease in seizures from baseline to exit.|
1760236|NCT00159965|3232549|Superiority or Other||Risk Ratio, log|-0.598|Standard Error of the Mean|0.276||0.03|2-Sided|95.0|-1.139|-0.073|||Overdispersed Poisson Regression|||Within-group seizure change. The hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.|
1760237|NCT00159965|3232549|Superiority or Other||Risk Ratio, log|0.673|Standard Error of the Mean|0.369||0.29|2-Sided|95.0|-0.051|1.396|||Overdispersed Poisson Regression|||Between-group seizure change. The primary hypothesis of this pilot randomized control trial (RCT) was to assess the magnitude of seizure frequency reduction by treatment, comparing placbo to sertraline. The alternative hypothesis is that patients treated with sertraline will show a significant decrease in seizures from baseline to exit.|
1760238|NCT00159913|3232550|Superiority or Other||Mean Difference (Final Values)|5.24|Standard Error of the Mean|5.16||||95.0|-5.02|15.5|||||||
1760239|NCT00159913|3232550|Superiority or Other||Mean Difference (Final Values)|11.3|Standard Error of the Mean|5.36||||95.0|0.66|21.96|||||||
1760240|NCT00159913|3232550|Superiority or Other||Mean Difference (Final Values)|1.14|Standard Error of the Mean|5.35||||95.0|-9.49|11.77|||||||
1760241|NCT00159913|3232550|Superiority or Other||Mean Difference (Final Values)|5.89|Standard Error of the Mean|4.35||0.179||95.0|-2.74|14.53|||ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates|||
1760242|NCT00159913|3232551|Superiority or Other||Odds Ratio (OR)|4.52||||0.006||95.0|1.56|13.1|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.|||
1760243|NCT00159913|3232551|Superiority or Other||Odds Ratio (OR)|2.25||||0.146||95.0|0.75|6.69|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.|||
1760244|NCT00159913|3232551|Superiority or Other||Odds Ratio (OR)|0.6||||0.409||95.0|0.18|2.01|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.|||
1760245|NCT00159913|3232551|Superiority or Other||Odds Ratio (OR)|1.83||||0.184||95.0|0.75|4.45|||Regression, Logistic|Proportional odds method. Model covariates were baseline WHO functional class, etiology, weight group and capability of performing the exercise test.|||
1760246|NCT00159913|3232552|Superiority or Other||Mean Difference (Final Values)|0.46|Standard Error of the Mean|1.77||||95.0|-3.06|3.97|||||||
1760247|NCT00159913|3232552|Superiority or Other||Mean Difference (Final Values)|-2.11|Standard Error of the Mean|1.96||||95.0|-5.99|1.77|||||||
1760248|NCT00159913|3232552|Superiority or Other||Mean Difference (Final Values)|0.41|Standard Error of the Mean|1.97||||95.0|-3.49|4.3|||||||
1760249|NCT00159913|3232552|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|1.51||0.784||95.0|-3.41|2.58|||ANCOVA|The covariates included in the model were baseline scale, etiology, weight and capability of performing the exercise test.|||
1760250|NCT00159913|3232553|Superiority or Other||Mean Difference (Final Values)|-2.96|Standard Error of the Mean|2.23||||95.0|-7.37|1.45|||||||
1760251|NCT00159913|3232553|Superiority or Other||Mean Difference (Final Values)|0.24|Standard Error of the Mean|2.49||||95.0|-4.68|5.15|||||||
1760252|NCT00159913|3232553|Superiority or Other||Mean Difference (Final Values)|0.87|Standard Error of the Mean|2.57||||95.0|-4.21|5.95|||||||
1760253|NCT00159913|3232553|Superiority or Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|1.93||0.75||95.0|-4.45|3.21|||ANCOVA|The covariates included in the model were baseline scale, etiology, weight and capability of performing the exercise test.|||
1760254|NCT00159913|3232554|Superiority or Other||Mean Difference (Final Values)|-1.14|Standard Error of the Mean|0.75||||95.0|-2.61|0.33|||||||
1760255|NCT00159913|3232554|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.78||||95.0|-1.73|1.36|||||||
1760256|NCT00159913|3232554|Superiority or Other||Mean Difference (Final Values)|-0.17|Standard Error of the Mean|0.88||||95.0|-1.91|1.57|||||||
1760257|NCT00159913|3232554|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.64||0.44||95.0|-1.77|0.77|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test|||
1760258|NCT00159913|3232555|Superiority or Other||Mean Difference (Final Values)|0.89|Standard Error of the Mean|0.35||||95.0|0.21|1.58|||||||
1760259|NCT00159913|3232555|Superiority or Other||Mean Difference (Final Values)|0.61|Standard Error of the Mean|0.37||||95.0|-0.12|1.35|||||||
1760260|NCT00159913|3232555|Superiority or Other||Mean Difference (Final Values)|0.71|Standard Error of the Mean|0.41||||95.0|-0.1|1.52|||||||
1760261|NCT00159913|3232555|Superiority or Other||Mean Difference (Final Values)|0.74|Standard Error of the Mean|0.3||0.015||95.0|0.14|1.34|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test|||
1760262|NCT00159913|3232556|Superiority or Other||Mean Difference (Final Values)|-5.5|Standard Error of the Mean|2.4||||95.0|-10.3|-0.7|||||||
1760263|NCT00159913|3232556|Superiority or Other||Mean Difference (Final Values)|-3.4|Standard Error of the Mean|2.6||||95.0|-8.5|1.7|||||||
1760264|NCT00159913|3232556|Superiority or Other||Mean Difference (Final Values)|0.2|Standard Error of the Mean|2.9||||95.0|-5.5|5.9|||||||
1760265|NCT00159913|3232556|Superiority or Other||Mean Difference (Final Values)|-2.9|Standard Error of the Mean|2.1||0.172||95.0|-7.1|1.3|||ANCOVA|The model included the covariates etiology, weight group and capability of performing the exercise test|||
1760266|NCT00159913|3232557|Superiority or Other||Mean Difference (Final Values)|5.96|Standard Error of the Mean|7.62||||95.0|-9.16|21.08|||||||
1760267|NCT00159913|3232557|Superiority or Other||Mean Difference (Final Values)|11.43|Standard Error of the Mean|7.67||||95.0|-3.78|26.64|||||||
1760268|NCT00159913|3232557|Superiority or Other||Mean Difference (Final Values)|10.34|Standard Error of the Mean|7.84||||95.0|-5.21|25.9|||||||
1760269|NCT00159913|3232557|Superiority or Other||Mean Difference (Final Values)|9.24|Standard Error of the Mean|6.2||0.139||95.0|-3.05|21.54|||ANCOVA|The model included the covariates etiology and weight group|||
1760270|NCT00159913|3232558|Superiority or Other||Mean Difference (Final Values)|0.52|Standard Error of the Mean|2.9||||95.0|-5.24|6.28|||||||
1760271|NCT00159913|3232558|Superiority or Other||Mean Difference (Final Values)|-1.29|Standard Error of the Mean|2.92||||95.0|-7.09|4.5|||||||
1760272|NCT00159913|3232558|Superiority or Other||Mean Difference (Final Values)|2.62|Standard Error of the Mean|2.99||||95.0|-3.31|8.54|||||||
1760273|NCT00159913|3232558|Superiority or Other||Mean Difference (Final Values)|0.61|Standard Error of the Mean|2.36||0.795||95.0|-4.07|5.3|||ANCOVA|The model included the covariates etiology and weight group|||
1760274|NCT00159913|3232559|Superiority or Other||Mean Difference (Final Values)|-7.2|Standard Error of the Mean|2.3||||95.0|-11.7|-2.7|||||||
1760275|NCT00159913|3232559|Superiority or Other||Mean Difference (Final Values)|-4.5|Standard Error of the Mean|2.4||||95.0|-9.3|0.3|||||||
1760276|NCT00159913|3232559|Superiority or Other||Mean Difference (Final Values)|-0.6|Standard Error of the Mean|2.7||||95.0|-5.9|4.7|||||||
1760277|NCT00159913|3232559|Superiority or Other||Mean Difference (Final Values)|-4.1|Standard Error of the Mean|2.0||0.041||95.0|-8.0|-0.2|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met w/ main analysis: alternative=natural log transformed|||
1760278|NCT00159913|3232560|Superiority or Other||Mean Difference (Final Values)|-7.3|Standard Error of the Mean|2.6||||95.0|-12.4|-2.1|||||||
1760279|NCT00159913|3232560|Superiority or Other||Mean Difference (Final Values)|-3.5|Standard Error of the Mean|2.7||||95.0|-8.9|1.9|||||||
1760280|NCT00159913|3232560|Superiority or Other||Mean Difference (Final Values)|1.6|Standard Error of the Mean|3.1||||95.0|-4.5|7.6|||||||
1760281|NCT00159913|3232560|Superiority or Other||Mean Difference (Final Values)|-3.1|Standard Error of the Mean|2.2||0.172||95.0|-7.5|1.3|||ANCOVA|Covariates:etiology, wt grp, capability performing exercise test. Normality assumptions not met with main analysis: alternative=excluding outliers|||
1760282|NCT00159913|3232561|Superiority or Other||Mean Difference (Net)|7.98|Standard Error of the Mean|4.85||||95.0|-1.64|17.6|||||||
1760283|NCT00159913|3232561|Superiority or Other||Mean Difference (Net)|11.33|Standard Error of the Mean|4.84||||95.0|1.72|20.94|||||||
1760284|NCT00159913|3232561|Superiority or Other||Mean Difference (Net)|3.81|Standard Error of the Mean|5.0||||95.0|-6.11|13.73|||||||
1760285|NCT00159913|3232561|Superiority or Other||Mean Difference (Net)|7.71|Standard Error of the Mean|3.98||0.056||95.0|-0.19|15.6||No adjustments for multiple comparisons have been made.|ANCOVA|Analyses performed using analysis of covariance with etiology, weight and baseline peak VO2 as the covariates.|||
1760391|NCT00153101|3232900|Superiority or Other||Hazard Ratio (HR)|1.04||||0.2713||95.0|0.97|1.13|||Regression, Cox||||
1760286|NCT00159874|3232578|Superiority or Other||Least Square Mean Difference|-2.82|Standard Error of the Mean|6.01||0.64|2-Sided|95.0|-14.75|9.11|||ANCOVA||Least square mean difference of -2.82 was calculated as ‘ Sildenafil High Dose – Medium Dose’|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.|
1760287|NCT00159874|3232578|Superiority or Other||Least Square Mean Difference|-9.84|Standard Error of the Mean|5.92||0.1|2-Sided|95.0|-21.6|1.93|||ANCOVA||Least square mean difference of -9.84 was calculated as ‘ Sildenafil High Dose – Low Dose’|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.|
1760288|NCT00159874|3232578|Superiority or Other||Least Square Mean Difference|-7.02|Standard Error of the Mean|6.1||0.253|2-Sided|95.0|-19.13|5.09|||ANCOVA||Least square mean difference of -7.02 was calculated as ‘ Sildenafil Medium Dose – Low Dose’|Analyses were performed using analysis of covariance with etiology, weight, day of assessment and baseline peak VO2 as the covariates.|
1760289|NCT00159861|3232600|Superiority or Other||Kaplan-Meier estimate|0.369|||||2-Sided|95.0|0.302|0.437||||||5 Years: Proportion of participants who died.|
1760290|NCT00159861|3232600|Superiority or Other||Kaplan-Meier estimate|0.291|||||2-Sided|95.0|0.234|0.348||||||4 Years: Proportion of participants who died.|
1760291|NCT00159861|3232600|Superiority or Other||Kaplan-Meier estimate|0.26|||||2-Sided|95.0|0.205|0.315||||||3 Years: Proportion of participants who died.|
1760292|NCT00159861|3232600|Superiority or Other||Kaplan-Meier estimate|0.194|||||2-Sided|95.0|0.144|0.243||||||2 Years: Proportion of participants who died.|
1760293|NCT00159861|3232600|Superiority or Other||Kaplan-Meier estimate|0.095|||||2-Sided|95.0|0.059|0.132||||||1 Year: Proportion of participants who died.|
1760294|NCT00159822|3232606|Superiority or Other||Kaplan-Meier estimate overall survival|0.85||||||95.0|0.725|0.976|||||Global survival rate calculated using Kaplan-Meier estimate of overall survival.||
1760295|NCT00159822|3232612|Superiority or Other||Percent of subjects with success|43.9||||||95.0|28.5|60.3|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|EOT success=yes|
1760296|NCT00159822|3232612|Superiority or Other||Percent of subjects with success|33.3||||||95.0|18.6|51.0|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|Month 3 success=yes|
1760297|NCT00159822|3232613|Superiority or Other||Percent of subjects with success|31.7||||||95.0|18.08|48.09|||||Number of subjects with successful global outcomes were summarized and 95% two-sided confidence intervals based on the exact Clopper-Pearson method for the binomial distribution provided.|For sample size calculation, null hypothesis (p<p0) is defined as response rate <15% (ie, weak drug efficacy). Alternative hypothesis (p>pA) defined as response rate >30%. To reduce the chance of incorrectly rejecting the null hypothesis to 5% (α=5%) and incorrectly rejecting the alternate hypothesis to 20% (β=20%) it was calculated that a sample size of 48 subjects was required. Null hypothesis was rejected (assessing efficacy of study drug) if the number of eligible success was ≥ than n=12.|
1760298|NCT00159263|3232626|Other|Friedman Anova||||||0.04|||||||ANOVA||||
1760299|NCT00159263|3232627|Other|Friedman Anova||||||0.01|||||||ANOVA||||
1760300|NCT00159263|3232628|Other|Friedman ANOVA followed Dunn`s pairwise comparisons||||||0.04|||||||ANOVA||||
1760301|NCT00158860|3232643|Superiority or Other||||||<|0.001|||||||Wilcoxon rank sum test||||
1760302|NCT00158860|3232644|Superiority||Hazard Ratio (HR)|0.401|||<|0.001|2-Sided|95.0|0.282|0.57|||Log Rank||||
1760303|NCT00158860|3232644|Superiority||Kaplan-Meier estimates|27.3|||<|0.001|2-Sided|95.0|16.0|38.6|||Log Rank||||
1760304|NCT00158600|3232667|Superiority or Other||Difference|-0.37||||0.8333||95.0|-3.83|3.09||The threshold for determining statistical significance is 0.05. No adjustment for multiple comparison was made for secondary efficacy endpoints.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in PCS from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.|
1760305|NCT00158600|3232668|Superiority or Other||Difference|3.18||||0.1093||95.0|-0.73|7.08||The threshold for determining statistical significance is 0.05. No adjustment for multiple comparison was made for secondary efficacy endpoints.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in QMT from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.|
1760306|NCT00158600|3232669|Superiority or Other||Difference|3.4||||0.0055||95.0|1.03|5.77||The threshold for determining statistical significance is 0.05. A fixed testing sequence procedure was used to preserve an overall error rate of 5% for the co-primary efficacy endpoints by linking the test of FVC to the result of 6MWT.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in % predicted FVC from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.|
1760307|NCT00158600|3232670|Superiority or Other||Difference|28.12||||0.0347||95.0|2.07|54.17||The threshold for determining statistical significance is 0.05. A fixed testing sequence procedure was used to preserve an overall error rate of 5% for the co-primary efficacy endpoints by linking the test of FVC to the result of 6MWT.|ANCOVA|||The difference between alglucosidase alfa and placebo treatment groups in change in distance walked from baseline to last observation was estimated by ANCOVA after adjusting for baseline value and randomization strata.|
1760308|NCT00158262|3232674|Superiority||Mean Difference (Final Values)|2.9|||||2-Sided|95.0|-4.8|10.7|||||Placebo-Propranolol||
1760309|NCT00158262|3232675|Superiority||Mean Difference (Final Values)|-2.2|||||2-Sided|95.0|-20.3|16.0||||||CAPS Total Score at Month 3|
1760310|NCT00158262|3232675|Superiority||Mean Difference (Final Values)|0.0|||||2-Sided|95.0|-15.5|15.3|||||Placebo-Propranolol|CAPS Total Score at Month 1|
1760311|NCT00158262|3232676|Superiority||Mean Difference (Final Values)|7.0|||||2-Sided|95.0|-2.7|16.7|||||Placebo-Propranolol||
1760312|NCT00158197|3232682|Superiority or Other|||||||0.2|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.|
1760392|NCT00153101|3232901|Superiority or Other||Hazard Ratio (HR)|1.06||||0.3633||95.0|0.94|1.2|||Regression, Cox||||
1760313|NCT00158197|3232682|Superiority or Other|||||||0.68|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.|
1760314|NCT00158197|3232682|Superiority or Other|||||||0.78|||||||Generalized estimating equations|||We used GEE to investigate change in methamphetamine abstinence (i.e., provision of a negative methamphetamine UA) during the follow-up period.|
1760315|NCT00158197|3232683|Superiority or Other|||||||0.2|||||||t-test, 2 sided||||
1760316|NCT00158197|3232683|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1760317|NCT00158197|3232683|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1760318|NCT00158197|3232683|Superiority or Other||||||<|0.02||||||Yes, the a priori plan to handle post hoc multiple comparisons was to use the method of Bonferroni adjustment. Thus, the new alpha level for these comparisons was <0.0125.|ANOVA||||
1760319|NCT00158197|3232684|Superiority or Other||Odds Ratio (OR)|1.72|||<|0.01|||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.||
1760320|NCT00158197|3232684|Superiority or Other||Odds Ratio (OR)|2.4|||<|0.01|||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.||
1760321|NCT00158197|3232684|Superiority or Other||Odds Ratio (OR)|1.98|||<|0.01|2-Sided||||||Generalized estimating equations||Value represents the odds of submitting a methamphetamine negative urine sample in the treatment group (1 of 3) compared to the standard care group.||
1760322|NCT00157950|3232692|Non-Inferiority or Equivalence|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|99.1|||||2-Sided|95.0|95.0|100.0|||||Exact binomial confidence interval||
1760323|NCT00157950|3232693|Non-Inferiority or Equivalence|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|99.1|||||2-Sided|95.0|95.2|100.0|||||Exact binomial confidence interval||
1760324|NCT00157950|3232694|Non-Inferiority or Equivalence|The lower bound of the 95% confidence interval for the proportion of subjects receiving Gardasil who were seropositive at Week 4 postdose 3 must be greater than 90%|Proportion|100.0|||||2-Sided|95.0|96.8|100.0|||||Exact binomial confidence interval||
1760325|NCT00157950|3232695|Superiority or Other||Proportion|98.2|||||2-Sided|95.0|93.6|99.8|||||Exact binomial confidence interval||
1760326|NCT00157820|3232697|Superiority or Other||Odds Ratio (OR)|0.31||||0.0028|2-Sided|95.0|0.14|0.67|||Wilcoxon (Mann-Whitney)||An additional primary analysis was pre-planned: the odds ratio of CSAE-score between DC and SC obtained from SAS GENMOD procedure with the length of follow-up as an ‘offset’.|"The assumed effect of the DC treatment was a reduction from 30 to 15% in the proportion of patients who develop a CSAE, as well as a 15% reduction in the mean of CSAE (from 6 to 5.1). The estimated sample size was 200 (DC true) vs. 100 (SC true) patients followed for 8 months, with a two-sided alfa < 0.05 and a power of 88.8%.~The sample size was set up to 360 patients (120 patients per arm), considering losses in follow-up."|
1760327|NCT00157755|3232698|Superiority or Other|||||||0.236||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 4-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 4-hour gastric emptying from baseline to 12 months, µ ≠ 0"|
1760328|NCT00157755|3232698|Superiority or Other|||||||0.016||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 4-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 4-hour gastric emptying from baseline to 12 months, µ ≠ 0"|
1760329|NCT00157755|3232699|Superiority or Other||||||<|0.001||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 2-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 2-hour gastric emptying from baseline to 12 months, µ ≠ 0"|
1760330|NCT00157755|3232699|Superiority or Other||||||<|0.001||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in 2-hour gastric emptying from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in 2-hour gastric emptying from baseline to 12 months, µ ≠ 0"|
1760331|NCT00157755|3232700|Superiority or Other|||||||0.001||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in MCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in MCS score from baseline to 12 months, µ ≠ 0"|
1760332|NCT00157755|3232700|Superiority or Other|||||||0.009||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in MCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in MCS score from baseline to 12 months, µ ≠ 0"|
1760333|NCT00157755|3232701|Superiority or Other|||||||0.043||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in PCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in PCS score from baseline to 12 months, µ ≠ 0"|
1760334|NCT00157755|3232701|Superiority or Other||||||<|0.001||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in PCS score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in PCS score from baseline to 12 months, µ ≠ 0"|
1760335|NCT00157755|3232702|Superiority or Other||||||<|0.001||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in total symptom score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in total symptom score from baseline to 12 months, µ ≠ 0"|
1760393|NCT00153101|3232901|Superiority or Other||Hazard Ratio (HR)|0.94||||0.3732||95.0|0.83|1.07|||Regression, Cox||||
1760336|NCT00157755|3232702|Superiority or Other||||||<|0.001||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Paired t-test|||"Null hypothesis: There was no change in total symptom score from baseline to 12 months, µ = 0;~Alternative hypothesis: There was a change in total symptom score from baseline to 12 months, µ ≠ 0"|
1760337|NCT00157755|3232703|Superiority or Other||||||<|0.001||||||A one-sided significance level of 0.025 was applied to the test. No adjustments were made for multiple comparisons.|binomial, 1 sided|||"Null hypothesis: The percentage of responders was less than or equal to 50%;~Alternative hypothesis: The percentage of responders was greater than 50%"|
1760338|NCT00157755|3232703|Superiority or Other||||||<|0.014||||||A one-sided significance level of 0.025 was applied to the test. No adjustments were made for multiple comparisons.|binomial, 1 sided|||"Null hypothesis: The percentage of responders was less than or equal to 50%;~Alternative hypothesis: The percentage of responders was greater than 50%"|
1760339|NCT00157755|3232704|Superiority or Other||||||<|0.001||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change from baseline in the long-term frequency of weekly vomiting episodes, µ = 0;~Alternative hypothesis: There was a change from baseline in the long-term frequency of weekly vomiting episodes, µ ≠ 0"|
1760340|NCT00157755|3232704|Superiority or Other||||||<|0.001||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change from baseline in the long-term frequency of weekly vomiting episodes, µ = 0;~Alternative hypothesis: There was a change from baseline in the long-term frequency of weekly vomiting episodes, µ ≠ 0"|
1760341|NCT00157755|3232705|Superiority or Other|||||||0.932||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"|
1760342|NCT00157755|3232705|Superiority or Other|||||||0.903||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in total symptom score from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"|
1760343|NCT00157755|3232706|Superiority or Other|||||||1||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in the frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"|
1760344|NCT00157755|3232706|Superiority or Other|||||||0.215||||||A significance level of 0.05 was applied to the test. No adjustments were made for multiple comparisons.|Wilcoxon Signed Rank Test|||"Null hypothesis: There was no change in the frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ = 0;~Alternative hypothesis: There was a change in frequency of weekly vomiting episodes from when stimulation was turned OFF to when stimulation was turned ON, µ ≠ 0"|
1760345|NCT00157209|3232731|Superiority or Other||Hazard Ratio (HR)|0.745||||0.045|2-Sided|95.0|0.533|1.042|||Log Rank||||
1760346|NCT00157157|3232736|Superiority or Other||Odds Ratio (OR)|4.5||||||95.0|1.05|19.25|||||||
1760347|NCT00157157|3232737|Superiority or Other||Odds Ratio (OR)|4.18||||||95.0|1.18|14.82|||||||
1760348|NCT00157157|3232738|Superiority or Other||Odds Ratio (OR)|4.95||||||95.0|1.29|19.06|||||||
1760349|NCT00157014|3232752|Superiority or Other|||||||0.8373||||||No adjustments for multiple comparisons were performed.|Wilcoxon (Mann-Whitney)||||
1760350|NCT00157014|3232763|Superiority or Other|||||||0.4725||||||No adjustments for multiple comparisons were performed.|Wilcoxon (Mann-Whitney)||||
1760351|NCT00156065|3232804|Superiority or Other||Kaplan-Meier Estimate of Loss of Effect|0.9376||||||95.0|0.7631|0.9952|||||Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy.||
1760352|NCT00156065|3232804|Superiority or Other||Kaplan-Meier Estimate of Loss of Effect|0.8834||||||95.0|0.7744|0.955|||||Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy.||
1760353|NCT00156065|3232804|Superiority or Other||Kaplan-Meier Estimate of Loss of Effect|0.8619||||||95.0|0.6912|0.9644|||||Loss of effect = increase in total PANSS >=30% from start of current study; subjective worsening of schizophrenia/request for dose increase; Clinical Global Impressions of Severity of Illness score >=6; discontinuation for lack of efficacy.||
1760354|NCT00154102|3232830|Superiority or Other||Odds Ratio (OR)|3.02||||0.002|2-Sided|95.0|1.45|6.27|||Cochran-Mantel-Haenszel||||
1760355|NCT00154102|3232832|Superiority or Other||Odds Ratio (OR)|0.92||||0.6004|2-Sided|95.0|0.67|1.26|||Stratified cochran-mantel haenszel test|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)|
1760356|NCT00154102|3232833|Superiority or Other||Odds Ratio (OR)|0.822||||0.3475|2-Sided|95.0|0.544|1.242|||Cochran-Mantel-Haenszel|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)|
1760357|NCT00154102|3232834|Superiority or Other||Odds Ratio (OR)|2.069|||<|0.0001|2-Sided|95.0|1.515|2.826|||Cochran-Mantel-Haenszel|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)|
1760394|NCT00153101|3232902|Superiority or Other||Hazard Ratio (HR)|1.08||||0.2164||95.0|0.95|1.23|||Regression, Cox||||
1760395|NCT00153101|3232902|Superiority or Other||Hazard Ratio (HR)|1.19||||0.0082||95.0|1.05|1.35|||Regression, Cox||||
1760358|NCT00154102|3232835|Superiority or Other||Odds Ratio (OR)|1.4||||0.0038|2-Sided|95.0|1.12|1.77|||Stratified cochran-mantel haenszel test|||The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)|
1760359|NCT00154102|3232836|Superiority or Other||Hazard Ratio (HR)|1.035||||0.7549|2-Sided|95.0|0.834|1.284|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)|
1760360|NCT00154102|3232837|Superiority or Other||Hazard Ratio (HR)|0.796||||0.0093|2-Sided|95.0|0.67|0.946|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)|
1760361|NCT00154102|3232838|Superiority or Other||Hazard Ratio (HR)|0.878||||0.0419|2-Sided|95.0|0.774|0.995|||Stratified log rank|Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)|
1760362|NCT00154102|3232839|Superiority or Other||Hazard Ratio (HR)|1.171||||0.2648|2-Sided|95.0|0.887|1.544|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)|
1760363|NCT00154102|3232840|Superiority or Other||Hazard Ratio (HR)|0.696||||0.0012|2-Sided|95.0|0.558|0.867|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The two-sided stratified log-rank test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:<80 vs. ≥80)|
1760364|NCT00154102|3232841|Superiority or Other||Hazard Ratio (HR)|0.853||||0.0479|2-Sided|95.0|0.728|1.0|||Stratified log rank|Kaplan-Meier method was used to estimate median PFS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.||The study was planned with 633 progression events, in order to provide 80% power to test the null hypothesis of no difference in PFS time between treatment groups, assuming a hazard ratio (HR) of 0.8 of cetuximab + chemotherapy (CTX) over CTX alone. Significance level was fixed at 5%. The two-sided stratified log-rank test was employed, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and Karnovsky Performance Scale (KPS):<80 vs. ≥80)|
1760365|NCT00153803|3232874|Superiority||Hazard Ratio (HR)|1.18||||0.32|2-Sided|95.0|0.85|1.63|||Log Rank||||
1760366|NCT00153803|3232875|Superiority||Hazard Ratio (HR)|0.93||||0.165|2-Sided|95.0|0.65|1.33|||Log Rank||||
1760367|NCT00153101|3232880|Superiority or Other||Hazard Ratio (HR)|0.99||||0.8974||95.0|0.81|1.21|||Regression, Cox||||
1760368|NCT00153101|3232881|Superiority or Other||Hazard Ratio (HR)|0.9||||0.1431||95.0|0.78|1.04|||Regression, Cox||||
1760369|NCT00153101|3232882|Superiority or Other||Hazard Ratio (HR)|0.75||||0.0172||95.0|0.6|0.95|||Regression, Cox||||
1760370|NCT00153101|3232883|Superiority or Other||Risk Ratio (RR)|1.17||||0.0868||95.0|0.98|1.41|||Chi-squared||||
1760371|NCT00153101|3232884|Superiority or Other||Hazard Ratio (HR)|1.01||||0.9563||95.0|0.82|1.24|||Regression, Cox||||
1760372|NCT00153101|3232885|Superiority or Other||Hazard Ratio (HR)|1.39||||0.0101||95.0|1.08|1.79|||Regression, Cox||||
1760373|NCT00153101|3232886|Superiority or Other||Hazard Ratio (HR)|0.8||||0.0015||95.0|0.69|0.92|||Regression, Cox||||
1760374|NCT00153101|3232887|Superiority or Other||Hazard Ratio (HR)|0.66||||0.0085||95.0|0.48|0.9|||Regression, Cox||||
1760375|NCT00153101|3232888|Superiority or Other||Hazard Ratio (HR)|0.76||||0.0006||95.0|0.65|0.89|||Regression, Cox||||
1760376|NCT00153101|3232889|Superiority or Other||Hazard Ratio (HR)|0.8||||0.5798||95.0|0.36|1.76|||Regression, Cox||||
1760377|NCT00153101|3232890|Superiority or Other||Hazard Ratio (HR)|1.58||||0.0245||95.0|1.06|2.35|||Regression, Cox||||
1760378|NCT00153101|3232891|Superiority or Other||Hazard Ratio (HR)|1.05||||0.694||95.0|0.82|1.34|||Regression, Cox||||
1760379|NCT00153101|3232892|Superiority or Other||Hazard Ratio (HR)|0.83||||0.1365||95.0|0.64|1.06|||Regression, Cox||||
1760380|NCT00153101|3232893|Superiority or Other||Hazard Ratio (HR)|0.79||||0.0574||95.0|0.62|1.01|||Regression, Cox||||
1760381|NCT00153101|3232894|Superiority or Other||Hazard Ratio (HR)|1.03||||0.7764||95.0|0.85|1.24|||Regression, Cox||||
1760382|NCT00153101|3232895|Superiority or Other||Hazard Ratio (HR)|0.92||||0.2192||95.0|0.81|1.05|||Regression, Cox||||
1760383|NCT00153101|3232896|Superiority or Other||Hazard Ratio (HR)|0.87||||0.0483||95.0|0.76|1.0|||Regression, Cox||||
1760384|NCT00153101|3232897|Superiority or Other||Hazard Ratio (HR)|0.96||||0.4784||95.0|0.85|1.08|||Regression, Cox|||for subjects without atrial fibrillation at baseline|
1760385|NCT00153101|3232897|Superiority or Other||Hazard Ratio (HR)|0.94||||0.2666||95.0|0.83|1.05|||Regression, Cox|||for subjects without atrial fibrillation at baseline|
1760386|NCT00153101|3232898|Superiority or Other||Risk Ratio (RR)|1.04||||0.4337||95.0|0.94|1.17|||Chi-squared|||for subjects with available Mini Mental State Examination (MMSE) at baseline|
1760387|NCT00153101|3232898|Superiority or Other||Risk Ratio (RR)|0.99||||0.869||95.0|0.89|1.11|||Chi-squared|||for subjects with available Mini Mental State Examination (MMSE) at baseline|
1760388|NCT00153101|3232899|Superiority or Other||Hazard Ratio (HR)|1.14||||0.1235||95.0|0.96|1.36|||Regression, Cox|||for subjects without diabetes at baseline|
1760389|NCT00153101|3232899|Superiority or Other||Hazard Ratio (HR)|0.92||||0.3485||95.0|0.77|1.1|||Regression, Cox|||for subjects without diabetes at baseline|
1760396|NCT00153101|3232903|Superiority or Other||Hazard Ratio (HR)|0.92||||0.0606||95.0|0.85|1.0|||Regression, Cox||||
1760397|NCT00153101|3232903|Superiority or Other||Hazard Ratio (HR)|0.9||||0.0111||95.0|0.83|0.98|||Regression, Cox||||
1760398|NCT00153101|3232904|Superiority or Other||Hazard Ratio (HR)|0.9||||0.2396||95.0|0.75|1.07|||Regression, Cox||||
1760399|NCT00153101|3232904|Superiority or Other||Hazard Ratio (HR)|0.81||||0.0213||95.0|0.67|0.97|||Regression, Cox||||
1760400|NCT00153101|3232905|Superiority or Other||Hazard Ratio (HR)|0.93||||0.1251||95.0|0.84|1.02|||Regression, Cox||||
1760401|NCT00153101|3232905|Superiority or Other||Hazard Ratio (HR)|0.88||||0.0133||95.0|0.8|0.97|||Regression, Cox||||
1760402|NCT00153101|3232906|Superiority or Other||Hazard Ratio (HR)|0.88||||0.3436||95.0|0.68|1.14|||Regression, Cox||||
1760403|NCT00153101|3232906|Superiority or Other||Hazard Ratio (HR)|0.92||||0.5461|2-Sided|95.0|0.71|1.2|||Regression, Cox||||
1760404|NCT00153101|3232907|Superiority or Other||Hazard Ratio (HR)|0.95||||0.7468||95.0|0.68|1.32|||Regression, Cox||||
1760405|NCT00153101|3232907|Superiority or Other||Hazard Ratio (HR)|1.13||||0.4593||95.0|0.82|1.56|||Regression, Cox||||
1760406|NCT00153101|3232908|Superiority or Other||Hazard Ratio (HR)|1.07||||0.5297||95.0|0.86|1.34|||Regression, Cox||||
1760407|NCT00153101|3232908|Superiority or Other||Hazard Ratio (HR)|1.14||||0.255||95.0|0.91|1.42|||Regression, Cox||||
1760408|NCT00153101|3232909|Superiority or Other||Hazard Ratio (HR)|0.92||||0.6014||95.0|0.69|1.24|||Regression, Cox||||
1760409|NCT00153101|3232909|Superiority or Other||Hazard Ratio (HR)|0.87||||0.3682||95.0|0.63|1.18|||Regression, Cox||||
1760410|NCT00153101|3232910|Superiority or Other||Hazard Ratio (HR)|0.62||||0.0751|2-Sided|95.0|0.36|1.05|||Regression, Cox||||
1760411|NCT00153101|3232910|Superiority or Other||Hazard Ratio (HR)|0.88||||0.6248||95.0|0.54|1.45|||Regression, Cox||||
1760412|NCT00153101|3232911|Superiority or Other||Hazard Ratio (HR)|0.9||||0.7305||95.0|0.51|1.6|||Regression, Cox||||
1760413|NCT00153101|3232911|Superiority or Other||Hazard Ratio (HR)|1.25||||0.4221|2-Sided|95.0|0.73|2.15|||Regression, Cox||||
1760414|NCT00153101|3232912|Superiority or Other||Hazard Ratio (HR)|1.12||||0.1203||95.0|0.97|1.29|||Regression, Cox||||
1760415|NCT00153101|3232912|Superiority or Other||Hazard Ratio (HR)|0.95||||0.4984||95.0|0.82|1.1|||Regression, Cox||||
1760416|NCT00153101|3232913|Superiority or Other||Hazard Ratio (HR)|0.91||||0.1829||95.0|0.79|1.05|||Regression, Cox||||
1760417|NCT00153101|3232913|Superiority or Other||Hazard Ratio (HR)|0.92||||0.2248||95.0|0.79|1.06|||Regression, Cox||||
1760418|NCT00153101|3232914|Superiority or Other||Hazard Ratio (HR)|1.08||||0.2534||95.0|0.94|1.24|||Regression, Cox||||
1760419|NCT00153101|3232914|Superiority or Other||Hazard Ratio (HR)|1.08||||0.2909||95.0|0.94|1.23|||Regression, Cox||||
1760420|NCT00153101|3232915|Superiority or Other||Hazard Ratio (HR)|1.0||||0.9421||95.0|0.89|1.12|||Regression, Cox||||
1760421|NCT00153101|3232915|Superiority or Other||Hazard Ratio (HR)|1.04||||0.4535||95.0|0.93|1.17|||Regression, Cox||||
1760422|NCT00153101|3232916|Non-Inferiority or Equivalence|Non-inferiority margin was 1.13|Hazard Ratio (HR)|0.99||||0.0004||97.5|0.9|1.08|||Regression, Cox||||
1760423|NCT00153101|3232916|Superiority or Other||Hazard Ratio (HR)|1.0||||0.9086||95.0|0.93|1.09|||Regression, Cox||||
1760424|NCT00153101|3232917|Non-Inferiority or Equivalence|Non-inferiority margin was 1.13|Hazard Ratio (HR)|1.01||||0.0019||97.5|0.93|1.1|||Regression, Cox||||
1760425|NCT00153101|3232917|Superiority or Other||Hazard Ratio (HR)|0.99||||0.8462||95.0|0.92|1.07|||Regression, Cox||||
1760426|NCT00153062|3232918|Superiority or Other||Hazard Ratio (HR)|0.95||||0.2312|2-Sided|95.0|0.86|1.04|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline Modified Rankin score as covariates||Telmisartan vs placebo|
1760427|NCT00153062|3232919|Superiority or Other||Hazard Ratio (HR)|0.82||||0.1007|2-Sided|95.0|0.65|1.04|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline ACE-I use, and baseline modified Rankin score as covariates||Telmisartan vs Placebo|
1760428|NCT00153062|3232920|Superiority or Other||Hazard Ratio (HR)|0.94||||0.1073|2-Sided|95.0|0.87|1.01|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates.||Telmisartan vs Placebo|
1760429|NCT00153062|3232921|Superiority or Other||Hazard Ratio (HR)|0.99||||0.8292|2-Sided|95.0|0.92|1.07|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates||ASA+ER-DP vs Clopidogrel|
1760430|NCT00153062|3232922|Non-Inferiority or Equivalence|The pre-defined non-inferiority margin of 1.075|Hazard Ratio (HR)|1.01||||0.783|2-Sided|95.0|0.92|1.11|||Cox Proportional Hazard model|Cox proportional hazards model with age, baseline diabetes status, baseline ACE-I use, and baseline modified Rankin score as covariates||ASA+ER-DP vs clopidogrel|
1760431|NCT00152971|3232923|Superiority or Other|||||||0.0942|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760432|NCT00152971|3232923|Superiority or Other|||||||0.1416|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760433|NCT00152971|3232925|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760434|NCT00152971|3232925|Superiority or Other|||||||0.4968|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760435|NCT00152971|3232926|Superiority or Other|||||||0.0308|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760436|NCT00152971|3232926|Superiority or Other|||||||0.7724|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760437|NCT00152971|3232927|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760438|NCT00152971|3232927|Superiority or Other|||||||0.5774|||||||Fisher Exact|||Comparison versus Enoxaparin|
1760439|NCT00152971|3232928|Superiority or Other||Risk Difference (Percentage)|8.9||||0.0004||95.0|4.0|13.9|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760543|NCT00150592|3233072|Superiority or Other (legacy)|||||||0.007|||||||Cochran-Mantel-Haenszel||||
1760440|NCT00152971|3232928|Superiority or Other||Risk Difference (Percentage)|5.9||||0.0194||95.0|1.0|10.9|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760441|NCT00152971|3232929|Superiority or Other||Risk Difference (Percentage)|1.5||||0.0602||95.0|-0.1|3.2|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760442|NCT00152971|3232929|Superiority or Other||Risk Difference (Percentage)|0.9||||0.2309||95.0|-0.6|2.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760443|NCT00152971|3232930|Superiority or Other||Risk Difference (Percentage)|0.8||||0.3628||95.0|-0.9|2.5|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760444|NCT00152971|3232930|Superiority or Other||Risk Difference (Percentage)|1.2||||0.2139||95.0|-0.7|3.0|||Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760445|NCT00152971|3232931|Non-Inferiority or Equivalence|Non-inferiority Analysis with NI margin 9.2% on the absolute risk difference scale|Risk Difference (Percentage)|8.4||||0.0009||95.0|3.4|13.3||Hierarchical testing procedure: first non-inferiority, second superiority|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760446|NCT00152971|3232931|Non-Inferiority or Equivalence|Non-inferiority Analysis with NI margin 9.2% on the absolute risk difference scale|Risk Difference (Percentage)|5.8||||0.0234||95.0|0.8|10.8||Hierarchical testing procedure: first non-inferiority, second superiority|Normal approximation|Normal approximation of independent binomial distribution without stratification||Risk difference versus Enoxaparin|
1760447|NCT00152464|3232990|Superiority or Other||Hazard Ratio (HR)|1.002|||=|0|2-Sided|95.0|0.75|1.338|||Regression, Cox||||
1760448|NCT00152009|3232991|Superiority or Other (legacy)|||||||0.0191|||||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category|
1760449|NCT00152009|3232991|Superiority or Other (legacy)|||||||0.1426|||||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category|
1760450|NCT00152009|3232991|Superiority or Other (legacy)|||||||0.1438|||||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.||Psychosocial category|
1760451|NCT00152009|3232992|Superiority or Other (legacy)||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1760452|NCT00152009|3232992|Superiority or Other (legacy)||||||<|0.0013|||||||Cochran-Mantel-Haenszel||||
1760453|NCT00152009|3232992|Superiority or Other (legacy)||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1760454|NCT00152009|3232993|Superiority or Other (legacy)|||||||0.0001|||||||Cochran-Mantel-Haenszel||||
1760455|NCT00152009|3232993|Superiority or Other (legacy)|||||||0.0016|||||||Cochran-Mantel-Haenszel||||
1760456|NCT00152009|3232993|Superiority or Other (legacy)||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1760457|NCT00152009|3232994|Superiority or Other (legacy)||||||<|0.0001|||||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.|||
1760458|NCT00152009|3232994|Superiority or Other (legacy)||||||<|0.0001|||||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.|||
1760459|NCT00152009|3232994|Superiority or Other (legacy)||||||<|0.0001|||||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.|||
1760460|NCT00152009|3232995|Superiority or Other (legacy)||||||<|0.0001|||||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.|||
1760461|NCT00152009|3232995|Superiority or Other (legacy)||||||<|0.035|||||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.|||
1760462|NCT00152009|3232995|Superiority or Other (legacy)||||||<|0.025|||||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.|||
1760463|NCT00152009|3232996|Superiority or Other (legacy)||||||<|0.0001|||||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.|||
1760464|NCT00152009|3232996|Superiority or Other (legacy)||||||<|0.0005|||||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.|||
1760465|NCT00152009|3232996|Superiority or Other (legacy)||||||<|0.0006|||||||ANCOVA|Employed Dunnett's adjustment for multiple pairwise comparisons. Corresponding baseline efficacy scores obtained were used as covariates.|||
1760466|NCT00151996|3232997|Superiority or Other (legacy)||||||<|0.0001|||||||t-test, 2 sided|||Change in psychosocial summary score|
1760467|NCT00151996|3232997|Superiority or Other (legacy)||||||<|0.9257|||||||t-test, 2 sided|||Change in physical summary score|
1760468|NCT00151996|3232997|Superiority or Other (legacy)||||||<|0.0001|||||||t-test, 2 sided|||Change in psychosocial summary score|
1760469|NCT00151996|3232997|Superiority or Other (legacy)||||||<|0.7004|||||||t-test, 2 sided|||Change in physical summary score|
1760470|NCT00151996|3232999|Superiority or Other (legacy)|||||||0.0002|||||||t-test, 2 sided|||Change from baseline in CPRS-R total score|
1760471|NCT00151996|3232999|Superiority or Other (legacy)||||||<|0.0001|||||||t-test, 2 sided|||Change from baseline in CPRS-R total score|
1760472|NCT00151996|3233001|Superiority or Other (legacy)||||||<|0.0001|||||||t-test, 2 sided|||Change from baseline in ADHD-RS-IV total score|
1760473|NCT00151996|3233001|Superiority or Other (legacy)||||||<|0.0001|||||||t-test, 2 sided|||Change from baseline in ADHD-RS-IV total score|
1760501|NCT00151476|3233027|Superiority or Other||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|3.68|64.16|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related events (months); 25th percentile.|
1760474|NCT00151892|3233006|Non-Inferiority or Equivalence|A 2-sided 95% confidence interval (CI) for the difference in the percentages of subjects in remission at 6 months of the two treatment groups will be computed. Non-inferiority of SPD476 to Asacol will be concluded if the lower limit of the 95% CI lies above the non-inferiority margin of -10%.|Difference in proportions|0.02||||||95.0|-0.04|0.08||||||The null hypothesis to be tested is that the true difference in proportions is less than or equal to -10%.|
1760475|NCT00151775|3233017|Superiority or Other||LS Mean difference|-2.92||||0.1496|2-Sided|95.0|-6.92|1.09|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.|
1760476|NCT00151775|3233017|Superiority or Other||LS Mean difference|-2.82||||0.2113|2-Sided|95.0|-7.29|1.65|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated systolic blood pressure the null hypothesis of no treatment difference was tested.|
1760477|NCT00151775|3233018|Superiority or Other||LS Mean difference|-2.8||||0.0032|2-Sided|95.0|-4.65|-0.95|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated diastolic blood pressure the null hypothesis of no treatment difference was tested.|
1760478|NCT00151775|3233018|Superiority or Other||LS Mean difference|-3.16||||0.0029|2-Sided|95.0|-5.24|-1.09|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||For seated systolic blood pressure the null hypothesis of no treatment difference was tested|
1760479|NCT00151775|3233018|Superiority or Other||LS Mean difference|-1.38||||0.3442|2-Sided|95.0|-4.27|1.5|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.|
1760480|NCT00151775|3233018|Superiority or Other||LS Mean difference|-2.57||||0.133|2-Sided|95.0|-5.93|0.79|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.|
1760481|NCT00151775|3233018|Superiority or Other||LS Mean difference|-3.49||||0.0052|2-Sided|95.0|-5.92|-1.05|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis for diastolic blood pressure. The null hypothesis of no treatment difference was tested.|
1760482|NCT00151775|3233018|Superiority or Other||LS Mean Difference|-3.58||||0.0093|2-Sided|95.0|-6.27|-0.89|||ANCOVA|The ANCOVA model used treatment and country as fixed effects and baseline as covariate.||Analysis of systolic blood pressure. Null hypothesis of no treatment difference was tested.|
1760483|NCT00151775|3233019|Superiority or Other||Slope|-7.71|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.|
1760484|NCT00151775|3233019|Superiority or Other||Slope|-8.36|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.|
1760485|NCT00151775|3233019|Superiority or Other||Slope|-6.85|||<|0.0084||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.|
1760486|NCT00151775|3233019|Superiority or Other||Slope|-7.17|||<|0.0265||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.|
1760487|NCT00151775|3233019|Superiority or Other||Slope|-8.15|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.|
1760488|NCT00151775|3233019|Superiority or Other||Slope|-8.97|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.|
1760489|NCT00151775|3233019|Superiority or Other||Slope|-0.57|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.|
1760490|NCT00151775|3233019|Superiority or Other||Slope|-0.75|||<|0.0001||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.|
1760491|NCT00151775|3233019|Superiority or Other||Slope|-0.58|||<|0.0125||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.|
1760492|NCT00151775|3233019|Superiority or Other||Slope|-0.85|||<|0.0032||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.|
1760493|NCT00151775|3233019|Superiority or Other||Slope|-0.057|||<|0.0026||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated diastolic blood pressure was carried out. The null hypothesis of zero-slope was tested.|
1760494|NCT00151775|3233019|Superiority or Other||Slope|0.69|||<|0.0008||95.0|||||Regression, Linear|||A linear regression analysis of olmesartan dose (non-weight adjusted) on the change from baseline in seated systolic blood pressure was carried out. The null hypothesis of zero-slope was tested.|
1760495|NCT00151775|3233020|Superiority or Other||||||<|0.0001|||||||Regression, Linear|||Weight adjusted dosage|
1760496|NCT00151775|3233020|Superiority or Other||||||<|0.0001|||||||Regression, Linear|||Non-weight adjusted dosage|
1760497|NCT00151775|3233020|Superiority or Other||||||<|0.0265|||||||Regression, Linear|||Weight adjusted dosage|
1760498|NCT00151775|3233020|Superiority or Other||||||<|0.0032|||||||Regression, Linear|||Non-weight adjusted dosage|
1760499|NCT00151775|3233020|Superiority or Other||||||<|0.0001|||||||Regression, Linear|||Weight adjusted dosage|
1760500|NCT00151775|3233020|Superiority or Other||||||<|0.0008|||||||Regression, Linear|||Non-weight adjusted dosage|
1760502|NCT00151476|3233027|Superiority or Other||Kaplan-Meier Estimate of Time to Event|21.22||||||95.0|4.07|64.16|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related events (months); 25th percentile.|
1760503|NCT00151476|3233029|Superiority or Other||Kaplan-Meier Estimate of Time to Event|20.22||||||95.0|12.35|40.31|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.|
1760504|NCT00151476|3233029|Superiority or Other||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|16.03|56.34|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.|
1760505|NCT00151476|3233029|Superiority or Other||Kaplan-Meier Estimate of Time to Event|40.21||||||95.0|8.31|105.68|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.|
1760506|NCT00151476|3233029|Superiority or Other||Kaplan-Meier Estimate of Time to Event|20.63||||||95.0|8.05|48.03|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.|
1760507|NCT00151476|3233030|Superiority or Other||Kaplan-Meier Estimate of Time to Event|11.28||||||95.0|9.07|38.24|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.|
1760508|NCT00151476|3233031|Superiority or Other||Kaplan-Meier Estimate of Time to Event|169.94||||||95.0|104.73|183.48|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.|
1760509|NCT00151476|3233031|Superiority or Other||Kaplan-Meier Estimate of Time to Event|137.34||||||95.0|104.73|183.48|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile. Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.|
1760510|NCT00151476|3233032|Superiority or Other||Kaplan-Meier Estimate of Time to Event|19.81||||||95.0|0.0|33.77|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.|
1760511|NCT00151476|3233032|Superiority or Other||Kaplan-Meier Estimate of Time to Event|5.98||||||95.0|0.0|33.77|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.|
1760512|NCT00151476|3233033|Superiority or Other||Kaplan-Meier Estimate of Time to Event|5.52||||||95.0|3.48|14.49|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.|
1760513|NCT00151476|3233033|Superiority or Other||Kaplan-Meier Estimate of Time to Event|5.06||||||95.0|3.48|11.76|||||Kaplan-Meier Estimate of Time to Event (months).|Time to FAP-related surgical events (months); 25th percentile.|
1760514|NCT00151476|3233033|Superiority or Other||Kaplan-Meier Estimate of Time to Event|14.49||||||95.0|3.48|301.64|||||Kaplan-Meier Estimate of Time to Event (months).|"Time to FAP-related surgical events (months); twenty-fifth (25th) percentile presented due to limited number of subjects.~Index date based on most recent colon and or rectum adenomatous polyps evaluation, most recent duodenal adenomatous polyps evaluation, and most recent desmoids tumors evaluation for Matched Control, Not Matched Celecoxib, and All Celecoxib Treated, respectively.~Only 13 matched pairs identified: p-values not computed in analysis of time-to-event endpoints"|
1760515|NCT00151411|3233034|Superiority||Mean Difference (Final Values)|4.6||||0.05|2-Sided|95.0|0.1|9.0|||Mixed Models Analysis||||
1760516|NCT00151411|3233035|Superiority||rate ratio|1.2||||0.51|2-Sided|95.0|0.7|1.9|||Zero-altered negative binomial model||Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.|This statistical analysis models the count of ovulations provided a woman actually ovulated.|
1760517|NCT00151411|3233035|Superiority||Rate Ratio|2.5||||0.07|2-Sided|95.0|0.9|6.6|||Zero-altered negative binomial model||Placebo is the reference group, i.e. for the rate ratio, Metformin represents the numerator and Placebo the denominator.|This statistical analysis models the probability of ovulation.|
1760518|NCT00151411|3233036|Superiority||Mean Difference (Final Values)|4.3||||0.54|2-Sided|95.0|-9.9|18.4|||Mixed Models Analysis||||
1760519|NCT00150969|3233050|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1760520|NCT00150969|3233057|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1760521|NCT00150618|3233065|Superiority or Other (legacy)|||||||0.1483|||||||ANCOVA|||Psychosocial category|
1760522|NCT00150618|3233065|Superiority or Other (legacy)|||||||0.2136|||||||ANCOVA|||Psychosocial category|
1760523|NCT00150618|3233065|Superiority or Other (legacy)|||||||0.5859|||||||ANCOVA|||Psychosocial category|
1760524|NCT00150618|3233065|Superiority or Other (legacy)|||||||0.0383|||||||ANCOVA|||Psychosocial category|
1760525|NCT00150618|3233066|Superiority or Other (legacy)|||||||0.0063|||||||Cochran-Mantel-Haenszel||||
1760526|NCT00150618|3233066|Superiority or Other (legacy)|||||||0.0017|||||||Cochran-Mantel-Haenszel||||
1760527|NCT00150618|3233066|Superiority or Other (legacy)|||||||0.4982|||||||Cochran-Mantel-Haenszel||||
1760528|NCT00150618|3233066|Superiority or Other (legacy)|||||||0.0303|||||||Cochran-Mantel-Haenszel||||
1760529|NCT00150618|3233067|Superiority or Other (legacy)|||||||0.0041|||||||Cochran-Mantel-Haenszel||||
1760530|NCT00150618|3233067|Superiority or Other (legacy)|||||||0.0055|||||||Cochran-Mantel-Haenszel||||
1760531|NCT00150618|3233067|Superiority or Other (legacy)|||||||0.1404|||||||Cochran-Mantel-Haenszel||||
1760532|NCT00150618|3233067|Superiority or Other (legacy)|||||||0.0074|||||||Cochran-Mantel-Haenszel||||
1760533|NCT00150618|3233068|Superiority or Other (legacy)|||||||0.0237|||||||ANCOVA||||
1760534|NCT00150618|3233068|Superiority or Other (legacy)|||||||0.0056|||||||ANCOVA||||
1760535|NCT00150618|3233068|Superiority or Other (legacy)|||||||0.0468|||||||ANCOVA||||
1760536|NCT00150618|3233068|Superiority or Other (legacy)|||||||0.001|||||||ANCOVA||||
1760537|NCT00150618|3233069|Superiority or Other (legacy)|||||||0.0006|||||||ANCOVA||||
1760538|NCT00150618|3233069|Superiority or Other (legacy)|||||||0.0016|||||||ANCOVA||||
1760539|NCT00150618|3233069|Superiority or Other (legacy)|||||||0.0176|||||||ANCOVA||||
1760540|NCT00150618|3233069|Superiority or Other (legacy)|||||||0.0041|||||||ANCOVA||||
1760541|NCT00150592|3233070|Superiority or Other (legacy)|||||||0.231|||||||ANCOVA||||
1760544|NCT00150592|3233073|Superiority or Other (legacy)|||||||0.001|||||||ANCOVA||||
1760545|NCT00150592|3233074|Superiority or Other (legacy)|||||||0.068|||||||ANCOVA|||Strategy|
1760546|NCT00150592|3233074|Superiority or Other (legacy)|||||||0.917|||||||ANCOVA|||Double errors|
1760547|NCT00150592|3233074|Superiority or Other (legacy)|||||||0.552|||||||ANCOVA|||Within errors|
1760548|NCT00150592|3233074|Superiority or Other (legacy)|||||||0.307|||||||ANCOVA|||Between errors|
1760549|NCT00150592|3233076|Superiority or Other (legacy)|||||||0.274|||||||ANCOVA|Mean reaction time (adjusted) for each randomized treatment group at endpoint.|||
1760550|NCT00150592|3233077|Superiority or Other (legacy)|||||||0.844|||||||ANCOVA||||
1760551|NCT00150345|3233088|Superiority or Other||Difference in percentages|2.51|||||2-Sided|95.0|-14.96|19.97||||||Difference in proportions expressed as a percent: immediate voriconazole vs deferred voriconazole treatment|
1760552|NCT00150345|3233108|Superiority or Other||Mean Difference (Final Values)|-22.031|Standard Error of the Mean|10.888||0.049|2-Sided|95.0|-44.004|-0.059||SAS PROC REG with SELECTION=STEPWISE option of SLENTRY=0.05 and SLSTAY=0.10 utilized. Stepwise option combined forward stepping (with a 0.05 level to enter) with elimination of variables already in model that do not stay significant at 0.10 level.|Regression, Linear|Variables: association with age, c-reactive protein, and time to continuous defervescence not significant at 0.05 level; not included in final model||Continuous defervescence achieved=Yes|
1760553|NCT00150345|3233109|Superiority or Other|||||||0.19|||||||Log Rank||||
1760554|NCT00150345|3233110|Superiority or Other||Difference in % participants that died|5.85|||||2-Sided|95.0|-5.08|16.78|||||Approximate 2-sided confidence interval (CI).|Difference in proportions expressed as a percent: immediate voriconazole versus (vs) deferred voriconazole treatment|
1760555|NCT00150345|3233112|Superiority or Other|||||||0.955|||||||Log Rank||||
1760556|NCT00150345|3233113|Superiority or Other||Odds Ratio (OR)|0.936||||0.864|2-Sided|95.0|0.441|1.988|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event defervescence=yes is modeled.||
1760557|NCT00150345|3233114|Superiority or Other||Odds Ratio (OR)|0.822||||0.596|2-Sided|95.0|0.398|1.696|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event defervescence=yes is modeled.||
1760558|NCT00150345|3233115|Superiority or Other||Odds Ratio (OR)|0.493||||0.258|2-Sided|95.0|0.129|1.755|||Regression, Logistic||Odds ratio computed from the logistic regression (logit model) including terms for treatment arm, concomitant fluconazole, and positive PCR before randomization. Event IFI=yes is modeled.|Hypothesis: H0: rv - rp = 0 vs H1: rv - rp does not equal 0, where ri is rate of IFI (i=v for voriconazole group, i=p for deferred voriconazole group). Logit model (including important covariates) used. The adjusted odds ratio and 95 percent (%) confidence interval (CI) for adjusted odds ratio calculated. If 95% CI around odds ratio does not contain a value of 1, then the null hypothesis of equal rates of IFI between immediate voriconazole and deferred voriconazole to be rejected.|
1760559|NCT00149825|3233127|Superiority or Other|||||||0.05|||||||Chi-squared|||We hypothesized that compared with MED+CTRL, a greater percent of participants in MED+CBTI will experience remission of insomnia.|
1760560|NCT00149825|3233128|Superiority or Other|||||||0.13|||||||Chi-squared|This is a one-tailed test||We hypothesized that compared with MED+CTRL, a greater percent of participants randomized to MED+CBTI will experience remission of depression|
1760561|NCT00149799|3233129|Superiority||Slope difference|0.05723|Standard Error of the Mean|0.1963||0.7724|2-Sided|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=36||"We compared change in Q-LES-Q-SF percent scores over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in Q-LES-Q-SF percent scores in the Escitalopram group will not be significantly different from that of the placebo group [to be tested]."|
1760562|NCT00149799|3233130|Superiority||Slope difference|0.001176|Standard Error of the Mean|0.03991||0.9766|2-Sided|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=43||"We compared change in functional impairment over time during trial phase 2 by treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in functional impairment in the Escitalopram group will not be significantly different from that of the placebo group [to be tested]."|
1760563|NCT00149799|3233131|Superiority||Slope difference|-0.07006|Standard Error of the Mean|0.04163||0.093|2-Sided|||||A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)|Mixed Models Analysis|Degrees of freedom=556||"We compared change in depression over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.~Null hypothesis: The rate of change in depression symptom severity in the Escitalopram group will not be significantly different from the placebo group [to be tested]."|
1760564|NCT00149799|3233133|Superiority or Other||Hazard Ratio (HR)|2.73||||0.048|2-Sided|95.0|1.01|8.59|||Regression, Cox|p-value is based on the likelihood ratio Chi-Square statistic.||Cox proportional hazards regression was used to compare relapse rates (accounting for censoring and time from randomization to relapse) in Phase II.|
1760565|NCT00149669|3233141|Superiority||Odds Ratio (OR)|0.61|||=|0|2-Sided|95.0|0.29|1.26|||General Estimating Equation (GEE)||||
1760566|NCT00149669|3233142|Superiority||Odds Ratio (OR)|0.91||||0.82|2-Sided|95.0|0.43|1.95|||General Estimating Equation (GEE)||||
1760567|NCT00149669|3233143|Superiority||Odds Ratio (OR)|8.67|||<|0.01|2-Sided|95.0|4.24|17.73|||General Estimating Equation (GEE)||||
1760626|NCT00147745|3233256|Superiority or Other||Mean Difference (Final Values)|-0.03|Standard Error of the Mean|0.083||0.6855||95.0|-0.2|0.14|||ANCOVA||||
1760568|NCT00149643|3233146|Superiority or Other||||||<|0.05|||||||ANOVA|||Groups’ categorical baseline measures were compared by chi-square analysis, corrected for continuity. Statistical analyses were completed on an intent to-treat study group basis. Outcome measures for depression and for cannabis use and alcohol use across treatment groups were compared by repeated measures analysis of variance. The last observation carried forward (LOCF)method was used for handling missing data in the data analyses.|
1760569|NCT00149227|3233174|Superiority or Other||Cox Proportional Hazard|0.8|Standard Deviation|2.0|<|0.05|2-Sided|95.0|-0.975|0.975|||Cox's proportional hazard analysis|||"We estimated the number of enrolled patients to validate the hypothesis under the assumption that the valsartan add-on group achieves a 20% risk reduction compared with the conventional treatment group and gives 80% statistical power for detecting a clinical signiﬁcance with a two-tailed 5% statistical signiﬁcant level.~with a two-tailed 5% statistical signiﬁcant level."|
1760570|NCT00149214|3233179|Superiority or Other||Percentage of Participants|20.2||||||95.0|13.4|28.5||||||Confidence Interval for pathological complete response in the Cyclophosphamide treatment group.|
1760571|NCT00149214|3233179|Superiority or Other||Percentage of Participants|16.5||||||95.0|10.5|24.2||||||Confidence Interval for pathological complete response in the Pemetrexed treatment arm.|
1760572|NCT00148954|3233183|Superiority or Other||Hazard Ratio (HR)|1.34||||0.003|2-Sided|95.0|1.11|1.62|||Regression, Cox||||
1760573|NCT00148941|3233199|Non-Inferiority|Non-inferiority objective was considered demonstrated, when the upper limit of the 95% CI for the difference between groups (SB213503 + M-M-R Group = pooled lot 1, 2 & 3 groups minus Infanrix + IPOL + M-M-R Group) in percentage of subjects reporting increased circumferential swelling was equal or less than 2%.|Difference in percentage|-0.41|||||2-Sided|95.0|-1.26|0.16||||||Non-inferiority of the SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of the incidence of increased circumferential swelling at the SB213503 and Infanrix injection site, defined as an injection site swelling diameter that involves > 50% of the length of the upper arm that also is associated with a > 30 mm increase of the mid-upper arm circumference compared to the baseline measurement.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
1760574|NCT00148941|3233200|Non-Inferiority|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|-0.82|||||2-Sided|95.0|-3.79|1.14||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertactin (PRN) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 & 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
1760575|NCT00148941|3233200|Non-Inferiority|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.79|||||2-Sided|95.0|-2.5|3.21||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of filamentous haemagglutinin (FHA) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 & 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
1760576|NCT00148941|3233200|Non-Inferiority|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.36|||||2-Sided|95.0|-3.83|3.71||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of pertussis toxoid (PT) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 & 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
1760577|NCT00148941|3233201|Non-Inferiority|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|-2.81|||||2-Sided|95.0|-6.55|-0.09||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of tetanus toxoid (T) booster responses (measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 & 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
1760587|NCT00148941|3233202|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMT ratio|1.118|||||2-Sided|95.0|0.951|1.314||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760627|NCT00147745|3233256|Superiority or Other||Mean Difference (Final Values)|0.08|Standard Error of the Mean|0.065||0.2042||95.0|-0.05|0.22|||ANCOVA||||
1760748|NCT00145600|3233487|Superiority or Other (legacy)||||||<|0.0687|||||||Wilcoxon signed rank test||||
1760578|NCT00148941|3233201|Non-Inferiority|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|Difference between groups|0.47|||||2-Sided|95.0|-0.98|1.21||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of diphtheria toxoid (D) booster responses (i.e measured by the difference in percentage of subjects with a booster response between the Infanrix + IPOL + M-M-R Group and (minus) the SB213503 + M-M-R Group = pooled lot 1, 2 & 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
1760579|NCT00148941|3233202|Non-Inferiority|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ratio|0.938|||||2-Sided|95.0|0.811|1.085||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 3 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 & 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
1760580|NCT00148941|3233202|Non-Inferiority|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ratio|0.802|||||2-Sided|95.0|0.696|0.925||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 2 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 & 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
1760581|NCT00148941|3233202|Non-Inferiority|The objectives were achieved if for D, T, PT, FHA and PRN: the upper limit of the two-sided standardized asymptotic 95% CI of the difference in booster response rates was less than or equal to the pre-defined clinical limit of 10% AND for poliovirus types 1, 2 and 3: the upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio was less than or equal to the pre-defined clinical limit of 1.5.|GMT ration|0.792|||||2-Sided|95.0|0.68|0.922||||||Analysis of the non-inferiority of SB213503 vaccine compared to Infanrix + IPOL administered separately in terms of anti-poliovirus type 1 (measured by the GMT ratio of Infanrix + IPOL + M-M-R Group over SB213503 + M-M-R Group = pooled lot 1, 2 & 3 groups) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|SB213503 lot 1, SB213503 lot 2, and SB213503 lot 3 Arms/Groups were pooled for statistical analysis.
1760582|NCT00148941|3233202|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMT ratio|0.93|||||2-Sided|95.0|0.787|1.099||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760583|NCT00148941|3233202|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMT ratio|1.034|||||2-Sided|95.0|0.876|1.22||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760584|NCT00148941|3233202|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMT ratio|1.112|||||2-Sided|95.0|0.941|1.314||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 3 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760585|NCT00148941|3233202|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5] for Anti-poliovirus type 2.|GMT ratio|0.9|||||2-Sided|95.0|0.765|1.06||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760586|NCT00148941|3233202|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMT ratio|1.006|||||2-Sided|95.0|0.856|1.183||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 2 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760623|NCT00147745|3233255|Superiority or Other||Mean Difference (Final Values)|10.1|Standard Error of the Mean|69.98||0.8857||95.0|-132.6|152.9|||ANCOVA||||
1760624|NCT00147745|3233255|Superiority or Other||Mean Difference (Final Values)|-44.4|Standard Error of the Mean|53.17||0.4104||95.0|-152.8|64.1|||ANCOVA||||
1760625|NCT00147745|3233256|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.085||0.1727||95.0|-0.05|0.29|||ANCOVA||||
1760588|NCT00148941|3233202|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMT ratio|0.993|||||2-Sided|95.0|0.836|1.18||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760589|NCT00148941|3233202|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMT ratio|0.987|||||2-Sided|95.0|0.831|1.172||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760590|NCT00148941|3233202|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMTs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMT ratio|0.994|||||2-Sided|95.0|0.836|1.181||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of poliovirus type 1 geometric mean titers (GMTs) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760591|NCT00148941|3233203|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|1.045|||||2-Sided|95.0|0.909|1.202||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760592|NCT00148941|3233203|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|1.043|||||2-Sided|95.0|0.907|1.2||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760593|NCT00148941|3233203|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|0.998|||||2-Sided|95.0|0.867|1.148||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertactin (PRN) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760594|NCT00148941|3233203|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|1.084|||||2-Sided|95.0|0.971|1.209||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760595|NCT00148941|3233203|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|0.947|||||2-Sided|95.0|0.849|1.057||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760596|NCT00148941|3233203|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|0.874|||||2-Sided|95.0|0.783|0.976||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of filamentous haemagglutinin (FHA) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760597|NCT00148941|3233203|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|1.026|||||2-Sided|95.0|0.906|1.162||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760598|NCT00148941|3233203|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|0.963|||||2-Sided|95.0|0.85|1.091||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760599|NCT00148941|3233203|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|0.938|||||2-Sided|95.0|0.828|1.063||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of pertussis toxoid (PT) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1761032|NCT00141518|3233959|Superiority or Other|||||||0.035|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1760600|NCT00148941|3233204|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|0.901|||||2-Sided|95.0|0.8|1.014||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760601|NCT00148941|3233204|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|0.878|||||2-Sided|95.0|0.78|0.988||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760602|NCT00148941|3233204|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|0.975|||||2-Sided|95.0|0.866|1.097||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of tetanus toxoid (T) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760603|NCT00148941|3233204|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|0.991|||||2-Sided|95.0|0.89|1.103||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760604|NCT00148941|3233204|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% CIs for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|0.961|||||2-Sided|95.0|0.863|1.07||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760605|NCT00148941|3233204|Equivalence|Lot-to-lot consistency in terms of immunogenicity would be demonstrated if the lower and upper limits of the 95% confidence intervals (CIs) for the ratios of GMCs for each antigen (D, T, PT, FHA, PRN, and Poliovirus types 1, 2, and 3) and between each pair of the three lots of SB213503 vaccine were within the pre-defined clinical limits of [0.67; 1.5].|GMC ratio|0.97|||||2-Sided|95.0|0.871|1.08||||||The lot-to-lot consistency of three manufacturing lots of SB213503 vaccine in terms of diphtheria toxoid (D) in a subset of subjects one month after vaccination when co-administered with M-M-R II.|
1760606|NCT00148798|3233209|Superiority or Other|||||||0.6801|||||||Cochran-Mantel-Haenszel|||The disease control rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).|
1760607|NCT00148798|3233210|Superiority or Other|||||||0.0101|||||||Cochran-Mantel-Haenszel|||The best overall response rate was compared in the Cochran-Mantel-Haenszel test (two-sided with α=5%).|
1760608|NCT00148798|3233211|Superiority or Other|||||||0.3869|||||||Stratified Log Rank|||To test equality of progression free survival time between treatment groups, applying the two-sided stratified log-rank test (α=5%).|
1760609|NCT00148798|3233212|Superiority or Other|||||||0.0441|||||||Stratified Log Rank|||Primary efficacy analysis: To test equality of OS time between treatment groups, applying the two-sided stratified log-rank test (Stage IIIb vs IV, ECOG 0/1 vs 2) (α=5%).|
1760610|NCT00148343|3233226|Superiority||Slope|0.006|Standard Error of the Mean|0.026|<|0.05|2-Sided|95.0|-0.045|0.057|||Mixed Models Analysis||Slope is in reference to baseline to end of follow-up at 36 weeks||
1760611|NCT00148343|3233227|Superiority||Slope|-1.95|Standard Error of the Mean|5.53|||2-Sided|95.0|-12.79|8.89|||||Mixed models analysis. Slope refers to baseline to final follow up at 36 weeks||
1760612|NCT00148343|3233228|Superiority or Other||Slope|0.31|Standard Error of the Mean|7.35|<|0.05|2-Sided|95.0|-14.096|14.716|||Mixed Models Analysis||Slope is in reference to start of treatment to end of follow up at 36 weeks||
1760613|NCT00148343|3233229|Superiority||Slope|-5.07|Standard Error of the Mean|2.54|<|0.05|2-Sided|95.0|-10.05|-0.09|||Mixed Models Analysis||Slope is in reference to from baseline to end of follow-up at 36 weeks.||
1760614|NCT00148343|3233230|Superiority or Other||Slope|1.26|Standard Error of the Mean|0.76|||2-Sided|95.0|-0.2|2.75|||||Mixed model analysis. Slope is in reference to treatment x time interaction for full 36 weeks||
1760615|NCT00148109|3233239|Superiority or Other||||||<|0.05|||||||Fisher Exact|||Estimate a 4 month progression-free survival rate for each group.|
1760616|NCT00147823|3233251|Superiority or Other||||||<|0.01|||||||Chi-squared, Corrected||||
1760617|NCT00147823|3233252|Superiority or Other||||||<|0.01|||||||ANOVA|Using baseline (6 wk) and two year post operative predicted effects data, and setting desirable power to detect our effects to 80%||The sample size provided at least 80% power at a 5% alpha level to detect a medium to large effect in patients receiving Vitoss alone compared to combination therapy consisting of Vitoss with Bone Marrow Aspirate. Since a random coefficients model was used to analyze the data, the sample size calculation was estimated under this model assuming a 3% attrition rate between all measurement times.|
1760618|NCT00147745|3233253|Superiority or Other|||||||0.0362|||||||t-test, 2 sided||||
1760619|NCT00147745|3233254|Superiority or Other||Mean Difference (Final Values)|-0.97|Standard Error of the Mean|0.5||0.0613||95.0|-1.99|0.05|||ANCOVA||||
1760620|NCT00147745|3233254|Superiority or Other||Mean Difference (Final Values)|0.52|Standard Error of the Mean|0.515||0.3184||95.0|-0.53|1.57|||ANCOVA||||
1760621|NCT00147745|3233254|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.366||0.2286||95.0|-1.2|0.3|||ANCOVA||||
1760622|NCT00147745|3233255|Superiority or Other||Mean Difference (Final Values)|-54.5|Standard Error of the Mean|67.08||0.4226||95.0|-191.3|82.3|||ANCOVA||||
1761974|NCT00135226|3234631|Other||Rate Ratio|1.06|||||2-Sided|95.0|0.78|1.43|||||||
1760628|NCT00147745|3233257|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.091||0.3138||95.0|-0.09|0.28|||ANCOVA||||
1760629|NCT00147745|3233257|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.09||0.5723||95.0|-0.23|0.13|||ANCOVA||||
1760630|NCT00147745|3233257|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.07||0.5499||95.0|-0.1|0.19|||ANCOVA||||
1760631|NCT00147537|3233287|Superiority or Other||||||=|0|||||||binomial test|||A One-sided p-value for H0: objective response rate <=0.30 using exact binomial test at level 0.05.|
1760632|NCT00147537|3233288|Superiority or Other||||||=|0|||||||binomial test|||A one-sided p-value for H0: objective response rate <=0.28 using exact binomial test at level 0.05.|
1760633|NCT00147446|3233313|Superiority or Other||Odds Ratio (OR)|3.07||||0.006|2-Sided|95.0|1.38|6.81|||Logistic Regression|||It was hypothesized that significantly greater numbers of participants receiving SMT-MS remained free of new T2 lesions during the treatment, compared to control condition participants.|
1760634|NCT00147446|3233313|Superiority or Other||Wilcoxon two sample test statistics|2.84||||0.005||95.0|||||Wilcoxon (Mann-Whitney)|||It was hypothesized that participants receiving SMT-MS showed a significant reduction in cumulative new T2 lesions, compared to those receiving the control condition during the treatment period.|
1760635|NCT00147446|3233314|Superiority or Other||Odds Ratio (OR)|2.77||||0.02|2-Sided|95.0|1.17|6.55|||Logistic Regression|||It was hypothesized that significantly greater numbers of participants receiving stress management remained free of Gd+ lesions during the treatment, compared to those receiving the control condition.|
1760636|NCT00147446|3233314|Superiority or Other||Wilcoxon two smaple test statistics|2.09||||0.04||95.0|||||Wilcoxon (Mann-Whitney)|||It was hypothesized that treatment with stress management produced a significant reduction in cumulative Gd+ lesions compared to the control condition during the treatment period|
1760637|NCT00147199|3233332|Superiority or Other||Hodges-Lehman Estimate|-167.0||||0.001|2-Sided|95.0|-333.0|-64.0|||Wilcoxon rank sum test||||
1760638|NCT00147199|3233334|Superiority or Other||Hodges-Lehman Estimate|-1.0||||0.173|2-Sided|95.0|-2.0|0.0|||Wilcoxon rank sum test|||Emotional Dimension Score|
1760639|NCT00147199|3233334|Superiority or Other||Hodges-Lehman Estimate|-2.0||||0.037|2-Sided|95.0|-3.0|0.0|||Wilcoxon rank sum test|||Physical Dimension|
1760640|NCT00147199|3233334|Superiority or Other||Hodges-Lehman Estimate|-4.0||||0.027|2-Sided|95.0|-8.0|0.0|||Wilcoxon rank sum test|||Global Score|
1760641|NCT00147199|3233335|Superiority or Other||Hodges-Lehmann (H-L)|18.5||||0.0003|2-Sided|95.0|8.5|28.3|||Wilcoxon rank sum test||||
1760642|NCT00147199|3233336|Superiority or Other||Hodges-Lehmann (H-L)|13.7||||0.007|2-Sided|95.0|4.0|24.8|||ANCOVA||||
1760643|NCT00147199|3233337|Superiority or Other||Hodges-Lehmann (H-L)|0.0||||0.807|2-Sided|95.0|0.0|0.0||Imputation strategies were implemented for 16 inhaled treprostinil subjects and 9 placebo subjects without values reported at Week 12|Wilcoxon rank sum test||||
1760644|NCT00147199|3233338|Superiority or Other||Hodges-Lehmann (H-L)|0.0||||0.623|2-Sided|95.0|-0.5|0.0|||Wilcoxon rank sum test||||
1760645|NCT00147199|3233340|Superiority or Other||Hodges-Lehmann Estimate|20.0||||0.00044|2-Sided|95.0|8.0|32.8|||ANCOVA|Lowest rank was assigned for death, discontinuation due to disease progression, and for patients who initiated additional approved PAH therapy.||Sample size was calculated based on the primary endpoint; change in 6MWD at Week 12. Assuming a between-treatment difference of 35m, a standard deviation of 75m, and a type I (alpha) error of 0.05 (i.e., two-sided p-value of less than 0.05), in order to have 90% power to detect this difference, 100 subjects per treatment group were required for this trial (total n=200). This allowed for a dropout rate of 10% as 110 subjects per group was planned.|
1760646|NCT00147082|3233341|Superiority|||||||0.05||||||The p value (<0.05) was the threshold for significance|Kruskal-Wallis|||The p value was calculated|
1760647|NCT00147082|3233342|Superiority|||||||0.05||||||The p value (<0.05) was the threshold for significance|Kruskal-Wallis|||p value was calculated|
1760648|NCT00147082|3233343|Superiority|||||||0.05||||||The threshold for significance was p<0.05|Kruskal-Wallis|||p values were calculated|
1760649|NCT00147069|3233344|Superiority|||||||0.05|||||||Kruskal-Wallis||||
1760650|NCT00147069|3233345|Superiority|||||||0.05|||||||Kruskal-Wallis||||
1760651|NCT00147069|3233346|Superiority|||||||0.05||||||The reported p value was calculated|Kruskal-Wallis||||
1760652|NCT00147069|3233347|Superiority|||||||0.1|||||||Kruskal-Wallis||||
1760653|NCT00147017|3233372|Superiority|||||||0.05||||||calculated|Kruskal-Wallis||||
1760654|NCT00147017|3233373|Superiority|||||||0.05||||||calculated|Kruskal-Wallis||||
1760655|NCT00147017|3233374|Superiority|||||||0.05||||||calculated|Kruskal-Wallis||||
1760656|NCT00146848|3233375|Superiority or Other||Mean Difference (Final Values)|-13.24|Standard Error of the Mean|6.55||0.04|2-Sided|95.0|-26.11|-0.37|||t-test, 2 sided|||"Compare the difference in the changes in physical activity scores between groups using a t-test.~To adjust for multiple comparisons, an alpha level of 0.025 should be used to deem significance."|
1760657|NCT00146848|3233375|Superiority or Other||Mean Difference (Final Values)|-10.17|Standard Error of the Mean|6.35||0.11|2-Sided|95.0|-22.65|2.3|||t-test, 2 sided|||Compare the difference in the changes in physical activity scores between groups using a t-test.|
1760658|NCT00146848|3233376|Superiority or Other|||||||0.8|||||||Cochran-Armitage test for trend||||
1760659|NCT00146848|3233376|Superiority or Other|||||||0.55|||||||Cochran-Armitage test for trend|||One sided test testing for shift towards improvement in either atrial support pacing treatment arm compared to the DDD-40 arm.|
1760660|NCT00146848|3233377|Superiority or Other||Mean Difference (Final Values)|1.49|Standard Error of the Mean|1.87||0.43|2-Sided|95.0|-2.18|5.16|||t-test, 2 sided|||The difference in changes in quality of life between groups were compared using a t-test.|
1760661|NCT00146848|3233377|Superiority or Other||Mean Difference (Final Values)|0.3|Standard Error of the Mean|1.75||0.86|2-Sided|95.0|-3.14|3.74|||t-test, 2 sided|||The changes in quality of life were compared between groups using two-sided t-tests.|
1760697|NCT00145600|3233480|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.41|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760698|NCT00145600|3233480|Superiority or Other (legacy)||||||<|0.8663|||||||Wilcoxon signed rank test||||
1760662|NCT00145795|3233450|Superiority or Other|||||||0.61||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD8+ cell population at 6 months. Under the null hypothesis, percent CD8+ cell apoptosis is similar for both treatment groups.|
1760663|NCT00145795|3233451|Superiority or Other|||||||0.21||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD8+ cell population at 3 months. Under the null hypothesis, percent CD8+ cell apoptosis is similar for both treatment groups.|
1760664|NCT00145795|3233452|Superiority or Other|||||||0.04||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ naïve cell population at 6 months. Under the null hypothesis, percent CD4+ naïve cell apoptosis is similar for both treatment groups.|
1760665|NCT00145795|3233453|Superiority or Other|||||||0.29||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ memory cell population at 6 months. Under the null hypothesis, percent CD4+ memory cell apoptosis is similar for both treatment groups.|
1760666|NCT00145795|3233454|Superiority or Other|||||||0.29||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ naïve cell population at 3 months. Under the null hypothesis, percent CD4+ naïve cell apoptosis is similar for both treatment groups.|
1760667|NCT00145795|3233455|Superiority or Other|||||||0.08||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to assess the difference in mean percent apoptosis for the CD4+ memory cell population at 3 months. Under the null hypothesis, percent CD4+ memory cell apoptosis is similar for both treatment groups.|
1760668|NCT00145795|3233456|Superiority or Other|||||||0.03||||||Significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to examine the significance of the difference in mean absolute increase in CD4+ count at 6 months. Under the null hypothesis, CD4+ increase is similar for both treatment groups.|
1760669|NCT00145795|3233457|Superiority or Other|||||||0.81||||||The significance level is 5%.|t-test, 2 sided|This is a two-sample t-test assuming equal variances.||Two-sample Student's t-test was used to examine the significance of the difference in mean absolute increase in CD4+ count at 3 months. Under the null hypothesis, CD4+ increase is similar for both treatment groups.|
1760670|NCT00145626|3233473|Superiority or Other||Cumulative Incidence|0.214|Standard Error of the Mean|0.114|||2-Sided||||||||The cumulative incidence estimate and its standard error for occurrence of regimen-related mortality by the end of the first 100 days post-transplant was calculated.||
1760671|NCT00145600|3233476|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.55|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760672|NCT00145600|3233476|Superiority or Other (legacy)||||||<|0.8108|||||||Wilcoxon signed rank test||||
1760673|NCT00145600|3233476|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760674|NCT00145600|3233476|Superiority or Other (legacy)||||||<|0.0012|||||||Wilcoxon signed rank test||||
1760675|NCT00145600|3233476|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760676|NCT00145600|3233476|Superiority or Other (legacy)||||||<|0.004|||||||Wilcoxon signed rank test||||
1760677|NCT00145600|3233477|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.16||||0.0974||95.0|||||Spearman Correlation Coefficients||||
1760678|NCT00145600|3233477|Superiority or Other (legacy)|||||||0.9848|||||||Wilcoxon signed rank test||||
1760679|NCT00145600|3233477|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.27||||0.0024||95.0|||||Spearman Correlation Coefficients||||
1760680|NCT00145600|3233477|Superiority or Other (legacy)|||||||0.0135|||||||Wilcoxon signed rank test||||
1760681|NCT00145600|3233477|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.25||||0.0027||95.0|||||Spearman Correlation Coefficients||||
1760682|NCT00145600|3233477|Superiority or Other (legacy)|||||||0.0831|||||||Wilcoxon signed rank test||||
1760683|NCT00145600|3233478|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.56|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760684|NCT00145600|3233478|Superiority or Other (legacy)||||||<|0.1478|||||||Wilcoxon signed rank test||||
1760685|NCT00145600|3233478|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760686|NCT00145600|3233478|Superiority or Other (legacy)||||||<|0.0014|||||||Wilcoxon signed rank test||||
1760687|NCT00145600|3233478|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.37|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760688|NCT00145600|3233478|Superiority or Other (legacy)||||||<|0.0157|||||||Wilcoxon signed rank test||||
1760689|NCT00145600|3233479|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760690|NCT00145600|3233479|Superiority or Other (legacy)||||||<|0.0496|||||||Wilcoxon signed rank test||||
1760691|NCT00145600|3233479|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.39|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760692|NCT00145600|3233479|Superiority or Other (legacy)||||||<|0.0824|||||||Wilcoxon signed rank test||||
1760693|NCT00145600|3233479|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.36|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760694|NCT00145600|3233479|Superiority or Other (legacy)||||||<|0.4807|||||||Wilcoxon signed rank test||||
1760695|NCT00145600|3233480|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.58|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760696|NCT00145600|3233480|Superiority or Other (legacy)||||||<|0.7626|||||||Wilcoxon signed rank test||||
1760699|NCT00145600|3233480|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760700|NCT00145600|3233480|Superiority or Other (legacy)||||||<|0.7192|||||||Wilcoxon signed rank test||||
1760701|NCT00145600|3233481|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760702|NCT00145600|3233481|Superiority or Other (legacy)||||||<|0.02|||||||Wilcoxon signed rank test||||
1760703|NCT00145600|3233481|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.16|||<|0.0704||95.0|||||Spearman Correlation Coefficients||||
1760704|NCT00145600|3233481|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon signed rank test||||
1760705|NCT00145600|3233481|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.26|||<|0.0019||95.0|||||Spearman Correlation Coefficients||||
1760706|NCT00145600|3233481|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon signed rank test||||
1760707|NCT00145600|3233482|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.55|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760708|NCT00145600|3233482|Superiority or Other (legacy)||||||<|0.0468|||||||Wilcoxon signed rank test||||
1760709|NCT00145600|3233482|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760710|NCT00145600|3233482|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon signed rank test||||
1760711|NCT00145600|3233482|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.51|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760712|NCT00145600|3233482|Superiority or Other (legacy)||||||<|0.4263|||||||Wilcoxon signed rank test||||
1760713|NCT00145600|3233483|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.46|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760714|NCT00145600|3233483|Superiority or Other (legacy)||||||<|0.0846|||||||Wilcoxon signed rank test||||
1760715|NCT00145600|3233483|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760716|NCT00145600|3233483|Superiority or Other (legacy)||||||<|0.1731|||||||Wilcoxon signed rank test||||
1760717|NCT00145600|3233483|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760718|NCT00145600|3233483|Superiority or Other (legacy)||||||<|0.2758|||||||Wilcoxon signed rank test||||
1760719|NCT00145600|3233484|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760720|NCT00145600|3233484|Superiority or Other (legacy)||||||<|0.0017|||||||Wilcoxon signed rank test||||
1760721|NCT00145600|3233484|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.68|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760722|NCT00145600|3233484|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxan signed rank test||||
1760723|NCT00145600|3233484|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.53|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760724|NCT00145600|3233484|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon signed rank test||||
1760725|NCT00145600|3233485|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.54|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760726|NCT00145600|3233485|Superiority or Other (legacy)||||||<|0.0552|||||||Wilcoxon signed rank test||||
1760727|NCT00145600|3233485|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.37|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760728|NCT00145600|3233485|Superiority or Other (legacy)||||||<|0.0005|||||||Wilcoxon signed rank test||||
1760729|NCT00145600|3233485|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.45|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760730|NCT00145600|3233485|Superiority or Other (legacy)||||||<|0.005|||||||Wilcoxon signed rank test||||
1760731|NCT00145600|3233485|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.63|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760732|NCT00145600|3233485|Superiority or Other (legacy)||||||<|0.0281|||||||Wilcoxon signed rank test||||
1760733|NCT00145600|3233486|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.49|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760734|NCT00145600|3233486|Superiority or Other (legacy)||||||<|0.1474|||||||Wilcoxon signed rank test||||
1760735|NCT00145600|3233486|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.43|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760736|NCT00145600|3233486|Superiority or Other (legacy)||||||<|0.0038|||||||Wilcoxon signed rank test||||
1760737|NCT00145600|3233486|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.35|||<|0.0002||95.0|||||Spearman Correlation Coefficients||||
1760738|NCT00145600|3233486|Superiority or Other (legacy)||||||<|0.0282|||||||Wilcoxon signed rank test||||
1760739|NCT00145600|3233486|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.57|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760740|NCT00145600|3233486|Superiority or Other (legacy)||||||<|0.0014|||||||Wilcoxon signed rank test||||
1760741|NCT00145600|3233487|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.52|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760742|NCT00145600|3233487|Superiority or Other (legacy)||||||<|0.3121|||||||Wilcoxon signed rank test||||
1760743|NCT00145600|3233487|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.49|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760744|NCT00145600|3233487|Superiority or Other (legacy)||||||<|0.2999|||||||Wilcoxon signed rank test||||
1760745|NCT00145600|3233487|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760746|NCT00145600|3233487|Superiority or Other (legacy)||||||<|0.9478|||||||Wilcoxon signed rank test||||
1760747|NCT00145600|3233487|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.65|||<|0.0001||95.0|||||Spearman Correlation Coefficient||||
1760749|NCT00145600|3233488|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.26||||0.0061||95.0|||||Spearman Correlation Coefficients||||
1760750|NCT00145600|3233488|Superiority or Other (legacy)|||||||0.0014|||||||Wilcoxon signed rank test||||
1760751|NCT00145600|3233488|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.39|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760752|NCT00145600|3233488|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon Correlation Coefficients||||
1760753|NCT00145600|3233488|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.32|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760754|NCT00145600|3233488|Superiority or Other (legacy)||||||<|0.0004|||||||Wilcoxon signed rank test||||
1760755|NCT00145600|3233488|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.44|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760756|NCT00145600|3233488|Superiority or Other (legacy)||||||<|0.0254|||||||Wilcoxon signed rank test||||
1760757|NCT00145600|3233489|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.52|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760758|NCT00145600|3233489|Superiority or Other (legacy)||||||<|0.3624|||||||Wilcoxon signed rank test||||
1760759|NCT00145600|3233489|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.42|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760760|NCT00145600|3233489|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon signed rank test||||
1760761|NCT00145600|3233489|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.41|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760762|NCT00145600|3233489|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon signed rank test||||
1760763|NCT00145600|3233489|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.46|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760764|NCT00145600|3233489|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon signed rank test||||
1760765|NCT00145600|3233490|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.51|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760766|NCT00145600|3233490|Superiority or Other (legacy)||||||<|0.0197|||||||Wilcoxon signed rank test||||
1760767|NCT00145600|3233490|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.37|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760768|NCT00145600|3233490|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon signed rank test||||
1760769|NCT00145600|3233490|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.5|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760770|NCT00145600|3233490|Superiority or Other (legacy)||||||<|0.0001|||||||Wilcoxon signed rank test||||
1760771|NCT00145600|3233490|Superiority or Other (legacy)||Spearman Correlation Coefficients|0.6|||<|0.0001||95.0|||||Spearman Correlation Coefficients||||
1760772|NCT00145600|3233490|Superiority or Other (legacy)||||||<|0.3097|||||||Wilcoxon signed rank test||||
1760773|NCT00145600|3233491|Superiority or Other (legacy)||Kaplan Meier event-free survival estimat|0.788|||||2-Sided|95.0|0.698|0.878|||||||
1760774|NCT00145600|3233491|Superiority or Other (legacy)||Kaplan Meier event-free survival estimat|0.667|||||2-Sided|95.0|0.416|0.918|||||||
1760775|NCT00145600|3233491|Superiority or Other (legacy)||Kaplan Meier event-free survival estimat|0.844|||||2-Sided|95.0|0.7401|0.9479|||||||
1760776|NCT00145600|3233491|Superiority or Other (legacy)||Kaplan-Meier Event-free survival estimat|0.886|||||2-Sided|95.0|0.8096|0.9624|||||||
1760777|NCT00145574|3233500|Superiority or Other|||||||0.0003|||||||ANCOVA||||
1760778|NCT00145574|3233500|Superiority or Other|||||||0.7433|||||||ANCOVA||||
1760779|NCT00145574|3233501|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1760780|NCT00145574|3233501|Superiority or Other||||||<|0.0002|||||||ANCOVA||||
1760781|NCT00145574|3233502|Superiority or Other|||||||0.0006|||||||ANCOVA||||
1760782|NCT00145574|3233502|Superiority or Other|||||||0.3482|||||||ANCOVA||||
1760783|NCT00145574|3233503|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1760784|NCT00145574|3233503|Superiority or Other||||||<|0.0155|||||||ANCOVA||||
1760785|NCT00145574|3233504|Superiority or Other|||||||0.0008|||||||ANCOVA||||
1760786|NCT00145574|3233504|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1760787|NCT00145574|3233505|Superiority or Other|||||||0.0085|||||||ANCOVA||||
1760788|NCT00145574|3233505|Superiority or Other|||||||0.526|||||||ANCOVA||||
1760789|NCT00145574|3233506|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1760790|NCT00145574|3233506|Superiority or Other||||||<|0.1122|||||||ANCOVA|||The primary null hypotheses were tested sequentially in the following order: 1) no difference between the high-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with the last observation carried forward (LOCF) and 2) no difference between the low-dose colesevelam HCl and placebo for percent change in LDL-C from study baseline to Week 8 endpoint with LOCF. The hypotheses were tested at a 2-sided significance level of 5%.|
1760791|NCT00145496|3233511|Superiority or Other||||||<|0.0001||||||The test of hypothesis was a 2-tailed test with alpha=0.025 nominal significance using the Bonferroni adjustment to account for multiplicity of the key secondary comparisons.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in body weight between asenapine and olanzapine at Day 182.|
1760792|NCT00145496|3233512|Superiority or Other|||||||0.0565||||||The test of hypothesis was a 2-tailed test with alpha=0.025 nominal significance using the Bonferroni adjustment to account for multiplicity of the key secondary comparisons.|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in QLS total score between asenapine and olanzapine at Day 182.|
1760793|NCT00145496|3233513|Superiority or Other|||||||0.7177||||||The test of hypothesis was a 2-tailed test with alpha=0.05 (0.049 to adjust for one interim analysis).|Mixed Model for Repeated Measurements|||The null hypothesis was that there was no difference in change from baseline in NSA Scale total score between asenapine and olanzapine at Day 182.|
1760853|NCT00144339|3233584|Superiority or Other||Rate ratio of incidence rates|0.95||||0.5064||95.0|0.81|1.11|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)||
1760794|NCT00145470|3233514|Superiority|||||||0.2024||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||MCS - Change from Baseline at Day 84|
1760795|NCT00145470|3233514|Superiority|||||||0.1331||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||PCS - Change from Baseline at Day 84|
1760796|NCT00145470|3233515|Superiority|||||||0.0215||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||MCS - Change from Baseline at Day 21|
1760797|NCT00145470|3233515|Superiority|||||||0.128||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||PCS - Change from Baseline at Day 21|
1760798|NCT00145470|3233516|Superiority|||||||0.4884||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84|
1760799|NCT00145470|3233517|Superiority|||||||0.7493||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21|
1760800|NCT00145470|3233518|Superiority|||||||0.0613|||||||Log Rank||||
1760801|NCT00145470|3233519|Superiority|||||||0.8907||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Composite Memory - CFB at Day 84|
1760802|NCT00145470|3233519|Superiority|||||||0.5683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Sustained Attention - CFB at Day 84|
1760803|NCT00145470|3233519|Superiority|||||||0.9898||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Working Memory - CFB at Day 84|
1760804|NCT00145470|3233519|Superiority|||||||0.0514||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Executive Functioning - CFB at Day 84|
1760805|NCT00145470|3233519|Superiority|||||||0.1925||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Reasoning - CFB at Day 84|
1760806|NCT00145470|3233519|Superiority|||||||0.8051||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Social Acuity - CFB at Day 84|
1760807|NCT00145470|3233519|Superiority|||||||0.4878||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Processing Speed - CFB at Day 84|
1760808|NCT00145470|3233519|Superiority|||||||0.8805||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Visual Memory - CFB at Day 84|
1760809|NCT00145470|3233519|Superiority|||||||0.6914||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Verbal Memory - CFB at Day 84|
1760810|NCT00145470|3233520|Superiority|||||||0.2101||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Composite Memory - CFB at Day 21|
1760811|NCT00145470|3233520|Superiority|||||||0.8339||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Sustained Attention - CFB at Day 21|
1760812|NCT00145470|3233520|Superiority|||||||0.797||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Working Memory - CFB at Day 21|
1760813|NCT00145470|3233520|Superiority|||||||0.069||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Executive Functioning - CFB at Day 21|
1760814|NCT00145470|3233520|Superiority|||||||0.5975||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Reasoning - CFB at Day 21|
1760815|NCT00145470|3233520|Superiority|||||||0.3885||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Social Acuity - CFB at Day 21|
1760816|NCT00145470|3233520|Superiority|||||||0.3253||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Processing Speed - CFB at Day 21|
1760817|NCT00145470|3233520|Superiority|||||||0.7469||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Visual Memory - CFB at Day 21|
1760818|NCT00145470|3233520|Superiority|||||||0.055||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Verbal Memory - CFB at Day 21|
1760854|NCT00144339|3233585|Superiority or Other||Rate ratio of incidence rates|0.61||||0.0236||95.0|0.4|0.94|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)||
1760819|NCT00145470|3233521|Superiority|||||||0.1586||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84|
1760820|NCT00145470|3233522|Superiority|||||||0.6136||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21|
1760821|NCT00145470|3233523|Superiority|||||||0.9693||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84|
1760822|NCT00145470|3233524|Superiority|||||||0.5683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21|
1760823|NCT00145470|3233525|Superiority|||||||0.4683||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84|
1760824|NCT00145470|3233526|Superiority|||||||0.2492||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21|
1760825|NCT00145470|3233527|Superiority|||||||0.937||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84|
1760826|NCT00145470|3233528|Superiority|||||||0.3684||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21|
1760827|NCT00145470|3233529|Superiority|||||||0.0102||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84|
1760828|NCT00145470|3233530|Superiority|||||||0.0073||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21|
1760829|NCT00145470|3233531|Superiority|||||||0.7753||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84|
1760830|NCT00145470|3233532|Superiority|||||||0.3497||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21|
1760831|NCT00145470|3233533|Superiority|||||||0.0006||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84|
1760832|NCT00145470|3233534|Superiority|||||||0.0046||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21|
1760833|NCT00145470|3233535|Superiority|||||||0.0148|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 84|
1760834|NCT00145470|3233535|Superiority|||||||0.0196|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 63|
1760835|NCT00145470|3233535|Superiority|||||||0.0143|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 42|
1760836|NCT00145470|3233535|Superiority|||||||0.0158|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 21|
1760837|NCT00145470|3233535|Superiority|||||||0.1153|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 14|
1760838|NCT00145470|3233535|Superiority|||||||0.8837|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 7|
1760839|NCT00145470|3233535|Superiority|||||||0.3709|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 3|
1760840|NCT00145470|3233536|Superiority|||||||0.0152|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 84|
1760841|NCT00145470|3233536|Superiority|||||||0.0488|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 63|
1760842|NCT00145470|3233536|Superiority|||||||0.037|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 42|
1760843|NCT00145470|3233536|Superiority|||||||0.1634|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 21|
1760844|NCT00145470|3233536|Superiority|||||||0.0701|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 14|
1760845|NCT00145470|3233536|Superiority|||||||0.7923|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 7|
1760846|NCT00145470|3233536|Superiority|||||||0.3928|||||||Chi-squared|Based on Pearson’s chi-squared test.||Day 3|
1760847|NCT00145470|3233537|Superiority|||||||0.0073||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 84|
1760848|NCT00145470|3233538|Superiority|||||||0.021||||||P-value based on the difference in the LS means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 42|
1760849|NCT00145470|3233541|Superiority|||||||0.0257||||||P-value based on the difference in the least squares (LS) means for asenapine versus placebo.|ANCOVA|Based on an ANCOVA model with treatment and pooled investigative site as fixed effects and baseline as a covariate.||Change from Baseline at Day 21|
1760850|NCT00145119|3233574|Superiority or Other||proportion (%)|8.0|||||||||||||||
1760851|NCT00144391|3233582|Superiority|||||||0.08|||||||t-test, 2 sided||||
1760852|NCT00144339|3233583|Superiority or Other||Rate ratio of incidence rates|0.69||||0.0104||95.0|0.52|0.92|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)||
1761975|NCT00135226|3234632|Other||Risk Ratio|1.0|||||2-Sided|95.0|0.91|1.1|||||||
1760855|NCT00144339|3233586|Superiority or Other||Rate ratio of incidence rates|0.84||||0.0014||95.0|0.76|0.94|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)||
1760856|NCT00144339|3233587|Superiority or Other||Rate ratio of incidence rates|1.2||||0.4789||95.0|0.73|1.98|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)||
1760857|NCT00144339|3233588|Superiority or Other||Rate ratio of incidence rates|0.84||||0.0001||95.0|0.77|0.92|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)||
1760858|NCT00144339|3233589|Superiority or Other||Rate ratio of incidence rates|0.71||||0.0403||95.0|0.52|0.99|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)||
1760859|NCT00144339|3233590|Superiority or Other||Rate ratio of incidence rates|0.58||||0.0537||95.0|0.33|1.01|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)||
1760860|NCT00144339|3233591|Superiority or Other||Rate ratio of incidence rates|0.59||||0.0337||95.0|0.37|0.96|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)||
1760861|NCT00144339|3233592|Superiority or Other||Rate ratio of incidence rates|1.25||||0.2666||95.0|0.84|1.87|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)||
1760862|NCT00144339|3233593|Superiority or Other||Rate ratio of incidence rates|0.95||||0.7725||95.0|0.68|1.33|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)||
1760863|NCT00144339|3233594|Superiority or Other||Rate ratio of incidence rates|1.44||||0.1158||95.0|0.91|2.26|||Z-test||Rate ratio of incidence rates (tiotropium/placebo)||
1760864|NCT00144339|3233595|Superiority or Other||Rate ratio of incidence rates|0.84||||0.029||95.0|0.73|0.98|||Z-test|incidence rate = number of patients with event/ time at risk|Rate ratio of incidence rates (tiotropium/placebo)||
1760865|NCT00144339|3233596|Superiority or Other||Hazard Ratio (HR)|0.88||||0.2377||95.0|0.71|1.09|||Log Rank||Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tiotropium bromide vs. placebo||
1760866|NCT00144339|3233597|Superiority or Other||Hazard Ratio (HR)|0.85||||0.1936||95.0|0.67|1.08|||Log Rank||Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo||
1760867|NCT00144339|3233598|Superiority or Other||Hazard Ratio (HR)|0.89|Standard Error of the Mean|0.06||0.0859||95.0|0.79|1.02|||Log Rank||Cox regression; cut-off at 4 years plus 30 days; vital status form intended at 4 years; hazard ratio shown as tio vs. placebo||
1760868|NCT00144339|3233599|Superiority or Other||Hazard Ratio (HR)|0.87|Standard Error of the Mean|0.06||0.0339||95.0|0.76|0.99|||Log Rank||Cox regression; cut-off at 4 years ; vital status form intended at 4 years; hazard ratio shown as tio vs. placebo|Hazard ratio of all cause mortality vital status was information followed-up after discontinuation; vital status information up to 1440 days after the start of treatment was used|
1760869|NCT00144339|3233600|Superiority or Other||Hazard Ratio (HR)|0.85|Standard Error of the Mean|0.06||0.0242||95.0|0.74|0.98|||Log Rank||Cox regression with treatment; hazard ratio shown as tiotropium bromide vs. placebo||
1760870|NCT00144339|3233601|Superiority or Other||Mean Difference (Final Values)|-2.303|||<|0.0001||95.0|-3.266|-1.34|||ANOVA|Repeated measures ANOVA|||
1760871|NCT00144339|3233602|Superiority or Other||Mean Difference (Final Values)|-2.818|||<|0.0001||95.0|-3.742|-1.894|||ANOVA|Repeated measures ANOVA|||
1760872|NCT00144339|3233603|Superiority or Other||Mean Difference (Final Values)|-3.345|||<|0.0001||95.0|-4.229|-2.462|||ANOVA|Repeated measures ANOVA|||
1760873|NCT00144339|3233604|Superiority or Other||Mean Difference (Final Values)|-2.423|||<|0.0001||95.0|-3.277|-1.569|||ANOVA|Repeated measures ANOVA|||
1760874|NCT00144339|3233605|Superiority or Other||Mean Difference (Final Values)|-2.384|||<|0.0001||95.0|-3.191|-1.576|||ANOVA|Repeated measures ANOVA|||
1760875|NCT00144339|3233606|Superiority or Other||Mean Difference (Final Values)|-2.593|||<|0.0001||95.0|-3.352|-1.834|||ANOVA|Repeated measures ANOVA|||
1760876|NCT00144339|3233607|Superiority or Other||Mean Difference (Final Values)|-2.771|||<|0.0001||95.0|-3.461|-2.081|||ANOVA|Repeated measures ANOVA|||
1760877|NCT00144339|3233608|Superiority or Other||Mean Difference (Final Values)|-2.88|||<|0.0001||95.0|-3.535|-2.226|||ANOVA|Repeated measures ANOVA|||
1760878|NCT00144339|3233609|Superiority or Other||Mean Difference (Final Values)|0.026||||0.0915||95.0|-0.004|0.057|||ANOVA|Repeated measures ANOVA|||
1760879|NCT00144339|3233610|Superiority or Other||Mean Difference (Final Values)|0.15|||<|0.0001||95.0|0.119|0.182|||ANOVA|Repeated measures ANOVA|||
1760880|NCT00144339|3233611|Superiority or Other||Mean Difference (Final Values)|0.027||||0.0809||95.0|-0.003|0.057|||ANOVA|Repeated measures ANOVA|||
1760881|NCT00144339|3233612|Superiority or Other||Mean Difference (Final Values)|0.161|||<|0.0001||95.0|0.13|0.192|||ANOVA|Repeated measures ANOVA|||
1760882|NCT00144339|3233613|Superiority or Other||Mean Difference (Final Values)|0.05||||0.0004||95.0|0.022|0.078|||ANOVA|Repeated measures ANOVA|||
1760883|NCT00144339|3233614|Superiority or Other||Mean Difference (Final Values)|0.166|||<|0.0001||95.0|0.136|0.196|||ANOVA|Repeated measures ANOVA|||
1760884|NCT00144339|3233615|Superiority or Other||Mean Difference (Final Values)|0.031||||0.0248||95.0|0.004|0.059|||ANOVA|Repeated measures ANOVA|||
1760885|NCT00144339|3233616|Superiority or Other||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.141|0.199|||ANOVA|Repeated measures ANOVA|||
1760886|NCT00144339|3233617|Superiority or Other||Mean Difference (Final Values)|0.032||||0.0165||95.0|0.006|0.057|||ANOVA|Repeated measures ANOVA|||
1760887|NCT00144339|3233618|Superiority or Other||Mean Difference (Final Values)|0.167|||<|0.0001||95.0|0.139|0.194|||ANOVA|Repeated measures ANOVA|||
1760888|NCT00144339|3233619|Superiority or Other||Mean Difference (Final Values)|0.04||||0.002||95.0|0.015|0.065|||ANOVA|Repeated measures ANOVA|||
1760889|NCT00144339|3233620|Superiority or Other||Mean Difference (Final Values)|0.154|||<|0.0001||95.0|0.127|0.182|||ANOVA|Repeated measures ANOVA|||
1760890|NCT00144339|3233621|Superiority or Other||Mean Difference (Final Values)|0.032||||0.0069||95.0|0.009|0.055|||ANOVA|Repeated measures ANOVA|||
1760891|NCT00144339|3233622|Superiority or Other||Mean Difference (Final Values)|0.176|||<|0.0001||95.0|0.151|0.201|||ANOVA|Repeated measures ANOVA|||
1760892|NCT00144339|3233623|Superiority or Other||Mean Difference (Final Values)|0.037||||0.0018||95.0|0.014|0.06|||ANOVA|Repeated measures ANOVA|||
1761030|NCT00141518|3233958|Superiority or Other|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1760893|NCT00144339|3233624|Superiority or Other||Mean Difference (Final Values)|0.186|||<|0.0001||95.0|0.161|0.21|||ANOVA|Repeated measures ANOVA|||
1760894|NCT00144339|3233625|Superiority or Other||Mean Difference (Final Values)|0.038||||0.0002||95.0|0.018|0.058|||ANOVA|Repeated measures ANOVA|||
1760895|NCT00144339|3233626|Superiority or Other||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.147|0.192|||ANOVA|Repeated measures ANOVA|||
1760896|NCT00144339|3233627|Superiority or Other||Mean Difference (Final Values)|0.032||||0.0365||95.0|0.002|0.061|||ANOVA|Repeated measures ANOVA|||
1760897|NCT00144339|3233628|Superiority or Other||Mean Difference (Final Values)|0.17|||<|0.0001||95.0|0.139|0.201|||ANOVA|Repeated measures ANOVA|||
1760898|NCT00144339|3233629|Superiority or Other||Mean Difference (Final Values)|0.046||||0.002||95.0|0.017|0.076|||ANOVA|Repeated measures ANOVA|||
1760899|NCT00144339|3233630|Superiority or Other||Mean Difference (Final Values)|0.184|||<|0.0001||95.0|0.154|0.215|||ANOVA|Repeated measures ANOVA|||
1760900|NCT00144339|3233631|Superiority or Other||Mean Difference (Final Values)|0.065|||<|0.0001||95.0|0.038|0.093|||ANOVA|Repeated measures ANOVA|||
1760901|NCT00144339|3233632|Superiority or Other||Mean Difference (Final Values)|0.2|||<|0.0001||95.0|0.17|0.229|||ANOVA|Repeated measures ANOVA|||
1760902|NCT00144339|3233633|Superiority or Other||Mean Difference (Final Values)|0.047||||0.0005||95.0|0.021|0.074|||ANOVA|Repeated measures ANOVA|||
1760903|NCT00144339|3233634|Superiority or Other||Mean Difference (Final Values)|0.185|||<|0.0001||95.0|0.157|0.213|||ANOVA|Repeated measures ANOVA|||
1760904|NCT00144339|3233635|Superiority or Other||Mean Difference (Final Values)|0.059|||<|0.0001||95.0|0.035|0.084|||ANOVA|Repeated measures ANOVA|||
1760905|NCT00144339|3233636|Superiority or Other||Mean Difference (Final Values)|0.189|||<|0.0001||95.0|0.161|0.216|||ANOVA|Repeated measures ANOVA|||
1760906|NCT00144339|3233637|Superiority or Other||Mean Difference (Final Values)|0.05|||<|0.0001||95.0|0.026|0.074|||ANOVA|Repeated measures ANOVA|||
1760907|NCT00144339|3233638|Superiority or Other||Mean Difference (Final Values)|0.194|||<|0.0001||95.0|0.167|0.221|||ANOVA|Repeated measures ANOVA|||
1760908|NCT00144339|3233639|Superiority or Other||Mean Difference (Final Values)|0.048|||<|0.0001||95.0|0.026|0.07|||ANOVA|Repeated measures ANOVA|||
1760909|NCT00144339|3233640|Superiority or Other||Mean Difference (Final Values)|0.198|||<|0.0001||95.0|0.173|0.222|||ANOVA|Repeated measures ANOVA|||
1760910|NCT00144339|3233641|Superiority or Other||Mean Difference (Final Values)|0.055|||<|0.0001||95.0|0.034|0.076|||ANOVA|Repeated measures ANOVA|||
1760911|NCT00144339|3233642|Superiority or Other||Mean Difference (Final Values)|0.204|||<|0.0001||95.0|0.18|0.228|||ANOVA|Repeated measures ANOVA|||
1760912|NCT00144339|3233643|Superiority or Other||Mean Difference (Final Values)|0.055|||<|0.0001||95.0|0.037|0.073|||ANOVA|Repeated measures ANOVA|||
1760913|NCT00144339|3233644|Superiority or Other||Mean Difference (Final Values)|0.19|||<|0.0001||95.0|0.168|0.211|||ANOVA|Repeated measures ANOVA|||
1760914|NCT00144339|3233645|Superiority or Other||Mean Difference (Final Values)|0.049|||<|0.0001||95.0|0.033|0.065|||ANOVA|Repeated measures ANOVA|||
1760915|NCT00144339|3233646|Superiority or Other||Mean Difference (Final Values)|0.088|||<|0.0001||95.0|0.073|0.103|||ANOVA|Repeated measures ANOVA|||
1760916|NCT00144339|3233647|Superiority or Other||Mean Difference (Final Values)|0.061|||<|0.0001||95.0|0.045|0.076|||ANOVA|Repeated measures ANOVA|||
1760917|NCT00144339|3233648|Superiority or Other||Mean Difference (Final Values)|0.095|||<|0.0001||95.0|0.08|0.11|||ANOVA|Repeated measures ANOVA|||
1760918|NCT00144339|3233649|Superiority or Other||Mean Difference (Final Values)|0.065|||<|0.0001||95.0|0.051|0.08|||ANOVA|Repeated measures ANOVA|||
1760919|NCT00144339|3233650|Superiority or Other||Mean Difference (Final Values)|0.099|||<|0.0001||95.0|0.085|0.114|||ANOVA|Repeated measures ANOVA|||
1760920|NCT00144339|3233651|Superiority or Other||Mean Difference (Final Values)|0.061|||<|0.0001||95.0|0.047|0.075|||ANOVA|Repeated measures ANOVA|||
1760921|NCT00144339|3233652|Superiority or Other||Mean Difference (Final Values)|0.095|||<|0.0001||95.0|0.081|0.109|||ANOVA|Repeated measures ANOVA|||
1760922|NCT00144339|3233653|Superiority or Other||Mean Difference (Final Values)|0.062|||<|0.0001||95.0|0.049|0.075|||ANOVA|Repeated measures ANOVA|||
1760923|NCT00144339|3233654|Superiority or Other||Mean Difference (Final Values)|0.094|||<|0.0001||95.0|0.081|0.107|||ANOVA|Repeated measures ANOVA|||
1760924|NCT00144339|3233655|Superiority or Other||Mean Difference (Final Values)|0.053|||<|0.0001||95.0|0.04|0.066|||ANOVA|Repeated measures ANOVA|||
1760925|NCT00144339|3233656|Superiority or Other||Mean Difference (Final Values)|0.091|||<|0.0001||95.0|0.078|0.104|||ANOVA|Repeated measures ANOVA|||
1760926|NCT00144339|3233657|Superiority or Other||Median Difference (Final Values)|0.054|||<|0.0001||95.0|0.042|0.065|||ANOVA|Repeated measures ANOVA|||
1760927|NCT00144339|3233658|Superiority or Other||Mean Difference (Final Values)|0.103|||<|0.0001||95.0|0.091|0.115|||ANOVA|Repeated measures ANOVA|||
1760928|NCT00144339|3233659|Superiority or Other||Mean Difference (Final Values)|0.058|||<|0.0001||95.0|0.047|0.069|||ANOVA|Repeated measures ANOVA|||
1760929|NCT00144339|3233660|Superiority or Other||Mean Difference (Final Values)|0.099|||<|0.0001||95.0|0.087|0.11|||ANOVA|Repeated measures ANOVA|||
1760930|NCT00144339|3233661|Superiority or Other||Mean Difference (Final Values)|0.047|||<|0.0001||95.0|0.037|0.057|||ANOVA|Repeated measures ANOVA|||
1760931|NCT00144339|3233662|Superiority or Other||Mean Difference (Final Values)|0.087|||<|0.0001||95.0|0.077|0.098|||ANOVA|Repeated measures ANOVA|||
1760932|NCT00144339|3233663|Superiority or Other||Rate ratio|1.01||||0.8624||95.0|0.87|1.18|||t-test, 2 sided||Ratio of estimated number of days of chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization between tio and placebo|Poisson regression adjusting for overdispersion with Pearson’s method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.|
1760933|NCT00144339|3233664|Superiority or Other||Rate ratio|0.94|Standard Error of the Mean|0.06||0.3413||95.0|0.82|1.07|||t-test, 2 sided||Ratio of estimated number of events between tiotropium bromide and placebo||
1760934|NCT00144339|3233665|Superiority or Other||Hazard Ratio (HR)|0.86|Standard Error of the Mean|0.04||0.0024||95.0|0.78|0.95|||Log Rank||Hazard ratio shown as tiotropium bromide vs. placebo|Cox regression|
1760935|NCT00144339|3233666|Superiority or Other|||||||0.1766|||||||Fisher Exact||||
1760936|NCT00144339|3233667|Superiority or Other||Rate Ratio|0.89|Standard Error of the Mean|0.03||0.0011||95.0|0.83|0.95|||t-test, 2 sided||Poisson regression adjusting for overdispersion with Pearson’s method adjusting for treatment exposure. The logarithm of treatment exposure is used as offset when building the Poisson model.|Poisson regression adjusted for overdispersion and treatment exposure|
1760937|NCT00144339|3233668|Superiority or Other|||||||0.3481|||||||Fisher Exact||||
1760938|NCT00144339|3233669|Superiority or Other||Rate Ratio|0.86|Standard Error of the Mean|0.03|<|0.0001||95.0|0.81|0.91|||t-test, 2 sided||Ratio calculated as estimated number of events in tio/number of events in placebo|Poisson regression adjusted for overdispersion and treatment exposure|
1760939|NCT00144339|3233670|Superiority or Other||Hazard Ratio (HR)|0.86|Standard Error of the Mean|0.03|<|0.0001||95.0|0.81|0.91|||Log Rank|Cox regression with treatment|Median estimated by Kaplan-Meier estimates; hazard ratio shown as tio vs. placebo|Cox regression|
1760940|NCT00144339|3233671|Superiority or Other|||||||0.9814|||||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between|||
1760941|NCT00144339|3233672|Superiority or Other|||||||0.8103|||||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between|||
1760942|NCT00144339|3233673|Superiority or Other|||||||0.306|||||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between|||
1760943|NCT00144339|3233674|Superiority or Other|||||||0.2705|||||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between|||
1760944|NCT00144339|3233675|Superiority or Other||Mean Difference (Final Values)|0.04|Standard Error of the Mean|0.13||0.784||95.0|-0.2|0.3|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model|
1760945|NCT00144339|3233676|Superiority or Other||Median Difference (Final Values)|-1.0|Standard Error of the Mean|4.0||0.787||95.0|-9.0|7.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model|
1760946|NCT00144339|3233677|Superiority or Other||Median Difference (Final Values)|-6.0|Standard Error of the Mean|4.0||0.1143||95.0|-14.0|2.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model|
1760947|NCT00144339|3233678|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|4.0||0.8375||95.0|-9.0|7.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model|
1760948|NCT00144339|3233679|Superiority or Other||Mean Difference (Final Values)|-4.0|Standard Error of the Mean|4.0||0.299||95.0|-12.0|4.0|||t-test, 2 sided||Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model|
1760949|NCT00144339|3233680|Superiority or Other|||||||0.0145|||||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between|||
1760950|NCT00144339|3233681|Superiority or Other|||||||0.2488|||||||Wilcoxon Rank-sum test|Rate calculated as (measure on 30days after completion of treatment - measure on day 1 )/ years in between|||
1760951|NCT00144339|3233682|Superiority or Other||Mean Difference (Final Values)|2.0|Standard Error of the Mean|2.0||0.2074||95.0|-2.0|6.0|||t-test, 2 sided|Random-effects model|Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model|
1760952|NCT00144339|3233683|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|2.0||0.9524||95.0|-4.0|4.0|||t-test, 2 sided|Random-effects model|Arbitrary covariance matrix; fixed treatment effect; individual patients are random; rate of decline estimated as the slope of the random effects model|Linear random effects model|
1760953|NCT00144300|3233704|Superiority or Other||Risk Ratio (RR)|1.07||||||95.0|0.71|1.6|||||||
1760954|NCT00144170|3233705|Superiority or Other|||||||0.1026|||||||Log Rank||||
1760955|NCT00144170|3233779|Superiority or Other|||||||0.0001|||||||Log Rank||||
1760956|NCT00144170|3233780|Superiority or Other|||||||0.0001|||||||Log Rank||||
1760957|NCT00144170|3233781|Superiority or Other|||||||0.0001|||||||Log Rank||||
1760958|NCT00144170|3233782|Superiority or Other||Risk Difference (RD)|15.6||||0.0001|2-Sided|95.0|10.6|20.6||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel||||
1760959|NCT00144170|3233783|Superiority or Other||Risk Difference (RD)|16.2||||0.0001|2-Sided|95.0|11.1|21.3||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel||||
1760960|NCT00144170|3233784|Superiority or Other||Risk Difference (RD)|16.4||||0.0001|2-Sided|95.0|11.2|21.5||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel||||
1760961|NCT00144170|3233785|Superiority or Other||Risk Difference (RD)|17.3||||0.0001|2-Sided|95.0|12.0|22.5||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel||||
1760962|NCT00144170|3233786|Superiority or Other||Risk Difference (RD)|17.1||||0.0001|2-Sided|95.0|11.7|22.4||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel||||
1760963|NCT00144170|3233787|Superiority or Other||Risk Difference (RD)|17.2||||0.0001|2-Sided|95.0|11.7|22.7||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel||||
1760964|NCT00144170|3233788|Superiority or Other||Risk Difference (RD)|18.7||||0.0001|2-Sided|95.0|13.0|24.4||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel||||
1760965|NCT00144170|3233789|Superiority or Other||Risk Difference (RD)|19.0||||0.0001|2-Sided|95.0|13.3|24.7||Weighted by the size of enfuvirtide and protease inhibitor strata|Cochran-Mantel-Haenszel||||
1760966|NCT00144170|3233790|Superiority or Other||Risk Difference (RD)|22.1||||0.0001|2-Sided|95.0|16.2|27.9|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1760967|NCT00144170|3233791|Superiority or Other||Risk Difference (RD)|26.6||||0.0001|2-Sided|95.0|20.5|32.6|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1760968|NCT00144170|3233792|Superiority or Other||Risk Difference (RD)|29.4||||0.0001|2-Sided|95.0|23.2|35.7|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1760969|NCT00144170|3233793|Superiority or Other||Risk Difference (RD)|28.8||||0.0001|2-Sided|95.0|22.5|35.1|||Cochran-Mantel-Haenszel||||
1760970|NCT00144170|3233794|Superiority or Other||Risk Difference (RD)|24.9||||0.0001|2-Sided|95.0|18.6|31.1|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1760971|NCT00144170|3233795|Superiority or Other|||||||0.0001|||||||Log Rank||||
1760972|NCT00144170|3233796|Superiority or Other||Risk Difference (RD)|18.5||||0.0001|2-Sided|95.0|12.9|24.0|||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1760973|NCT00144027|3233797|Superiority or Other||Odds Ratio (OR)|7.57||||0.03|2-Sided|95.0|1.21|47.53|||Regression, Logistic|logistic regression predicting 6-month adherence, controling for baseline depression, extrapyramidal side effects, and baseline adherence.|||
1760974|NCT00143598|3233809|Superiority or Other||Hazard Ratio (HR)|1.13||||0.58|2-Sided|95.0|0.73|1.76|||Regression, Cox|Adjusted for centre|||
1760975|NCT00143507|3233810|Superiority or Other||Hazard Ratio (HR)|1.01||||0.835|2-Sided|95.0|0.9|1.13|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.||
1760976|NCT00143507|3233811|Superiority or Other||Hazard Ratio (HR)|1.04||||0.484|2-Sided|95.0|0.94|1.15|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.||
1760977|NCT00143507|3233812|Superiority or Other||Hazard Ratio (HR)|0.96||||0.411|2-Sided|95.0|0.86|1.06|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.||
1760978|NCT00143507|3233813|Superiority or Other||Hazard Ratio (HR)|0.9||||0.141|2-Sided|95.0|0.78|1.04|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.||
1760979|NCT00143507|3233814|Superiority or Other||Hazard Ratio (HR)|0.95||||0.501|2-Sided|95.0|0.81|1.11|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.||
1760980|NCT00143507|3233815|Superiority or Other||Hazard Ratio (HR)|1.08||||0.583|2-Sided|95.0|0.83|1.4|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.||
1760981|NCT00143507|3233816|Superiority or Other||Hazard Ratio (HR)|0.83||||0.078|2-Sided|95.0|0.67|1.02|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.||
1760982|NCT00143507|3233817|Superiority or Other||Hazard Ratio (HR)|0.89||||0.331|2-Sided|95.0|0.71|1.12|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.||
1760983|NCT00143507|3233818|Superiority or Other||Hazard Ratio (HR)|1.04||||0.547|2-Sided|95.0|0.92|1.16|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.||
1760984|NCT00143507|3233819|Superiority or Other||Hazard Ratio (HR)|0.99||||0.85|2-Sided|95.0|0.86|1.13|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.||
1760985|NCT00143507|3233820|Superiority or Other||Hazard Ratio (HR)|0.87||||0.159|2-Sided|95.0|0.72|1.06|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.||
1760986|NCT00143507|3233821|Superiority or Other||Hazard Ratio (HR)|1.07||||0.316|2-Sided|95.0|0.94|1.22|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.||
1760987|NCT00143507|3233822|Superiority or Other||Hazard Ratio (HR)|1.0||||0.945|2-Sided|95.0|0.91|1.1|||Regression, Cox||Estimate of the hazard ratio between treatment groups based on an adjusted Cox proportional hazards model with beta-blocker intake as a covariate. P-value: Log-rank test stratified on beta-blocker intake factor.||
1760988|NCT00143455|3233825|Superiority or Other||Hazard Ratio (HR)|0.965||||0.7544||95.0|0.771|1.208|||Cox Proportional Hazard Model||||
1760989|NCT00143455|3233826|Superiority or Other||Hazard Ratio (HR)|1.354||||0.0831||95.0|0.961|1.908|||Cox Proportional Hazard Model||||
1760990|NCT00143455|3233827|Non-Inferiority or Equivalence|A non-inferiority test was combined with a superiority test based on a closed testing procedure. The null hypothesis was to be rejected if the lower bound of the 2-sided 95% confidence interval for the hazard ratio (control/test) estimated from a Cox proportional hazards model, with an indicator for the control arm, was less than 0.80.|Hazard Ratio (HR)|1.35||||0.011||95.0|1.071|1.701|||Cox Proportional Hazard Model||||
1760991|NCT00143455|3233828|Superiority or Other||Odds Ratio (OR)|1.343||||0.143||95.0|0.905|1.993|||Chi-squared||||
1761031|NCT00141518|3233958|Superiority or Other|||||||0.599|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1760992|NCT00143455|3233829|Superiority or Other||Hazard Ratio (HR)|1.236||||0.0556||95.0|0.995|1.536|||Cox Proportional Hazard Model|||A non-inferiority test was combined with a superiority test based on a closed testing procedure. The null hypothesis was to be rejected if the lower bound of the 2-sided 95% confidence interval for the hazard ratio (control/test) estimated from a Cox proportional hazards model, with an indicator for the control arm, was less than 0.80.|
1760993|NCT00143403|3233831|Superiority or Other|||||||0.468|||||||Log Rank||||
1760994|NCT00143403|3233831|Superiority or Other||Hazard Ratio (HR)|0.9||||||95.0|0.67|1.2|||||HR: Irinotecan+5-FU/FA / 5-FU/FA||
1760995|NCT00143390|3233836|Non-Inferiority or Equivalence|Non-inferiority of exemestane to anastrozole was to be concluded if the upper bound of the 95% confidence interval on the hazard ratio (exemestane/anastrozole) was ≤1.25.|Hazard Ratio (HR)|1.059|||||2-Sided|95.0|0.816|1.374|||||Disease sites, use of postoperative adjuvant antiestrogen agents therapy, and pamidronate disodium were covariates for adjustment.|95% Confidence Interval based on the Brookmeyer and Crowley method|
1760996|NCT00143390|3233837|Non-Inferiority or Equivalence|Non-inferiority of exemestane to anastrozole was to be concluded if the upper bound of the 95% confidence interval on the hazard ratio (exemestane/anastrozole) was ≤1.25.|Hazard Ratio (HR)|1.007|||||2-Sided|95.0|0.771|1.317|||||Disease sites, use of postoperative adjuvant antiestrogen agents therapy, and pamidronate disodium were covariates for adjustment.|95% Confidence Interval based on the Brookmeyer and Crowley method|
1760997|NCT00143312|3233838|Superiority or Other||survive free of IFI (percent): 12 months|69.0||||||95.0|52.0|83.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage||
1760998|NCT00143312|3233838|Superiority or Other||survive free of IFI (percent): 6 months|79.0||||||95.0|64.0|91.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage||
1760999|NCT00143312|3233842|Superiority or Other||IFI Rate (percent) at End of Prophylaxis|8.82||||||95.0|2.0|24.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage||
1761000|NCT00143312|3233843|Superiority or Other||IFI Rate (percent) at 6 months|8.82||||||95.0|2.0|24.0|||||Exact 95% Confidence Interval For Proportion; Expressed as a percentage||
1761001|NCT00143312|3233844|Superiority or Other||IFI Rate (percent) at 12 months|10.0||||||95.0|2.0|27.0|||||||
1761002|NCT00143312|3233844|Superiority or Other||Crude IFI Rate (percent) at 12 months|7.0||||||95.0|2.0|19.0|||||||
1761003|NCT00142935|3233856|Superiority or Other|||||||0.8|||||||Chi-squared, Corrected||||
1761004|NCT00142935|3233858|Superiority or Other|||||||0.09|||||||Chi-squared, Corrected||||
1761005|NCT00142935|3233859|Superiority or Other|||||||0.09|||||||Chi-squared, Corrected||||
1761006|NCT00142935|3233860|Superiority or Other|||||||0.02|||||||Chi-squared, Corrected||||
1761007|NCT00142935|3233861|Superiority or Other||||||<|0.001|||||||Chi-squared, Corrected|||Outcome: engage in treatment post release, yes or no|
1761008|NCT00142792|3233873|Superiority||||||<|0.001||||||time effect, F(1,109)=91.1, p<0.001|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.|||
1761009|NCT00142792|3233873|Superiority or Other||||||<|0.27||||||time by group interaction effect, F(2,373) = 1.3, p =0.27|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.|||
1761010|NCT00142792|3233874|Superiority||||||<|0.001||||||time effect, F(1,109)=87.7, p<0.001)|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.|||
1761011|NCT00142792|3233874|Superiority or Other||||||<|0.18||||||Time by group interaction effect, F(2,372) = 1.8, p =0.18)|Mixed Models Analysis|A random intercept for each participant with a first-order antedependent covariance structure. Adjusted for site.||The study was powered to detect differences in FMA scores of a minimum effect size of 0.8 at a significance level of 0.01, the smallest effect size difference anticipated between Cyclic NMES and Cyclic Sensory Stimulation based on prior studies. A significance level of 0.01 in the power-analysis was taken since for each measurement occasion, three post-hoc tests are needed. To account for drop out of 20 % , the minimum number of participants required per group is 63.|
1761012|NCT00142415|3233881|Other|The maximum tolerated dose (MTD) was determined using a standard 3 + 3 dose-escalation design. The occurrence of DLTs was compared across cohorts.|Maximum tolerated dose (mCi/m^2)|65.0|||||2-Sided||||||||||
1761013|NCT00141778|3233931|Superiority or Other|||||||0.65|||||||Chi-squared||||
1761014|NCT00141778|3233932|Superiority or Other|||||||0.38|||||||Chi-squared||||
1761015|NCT00141778|3233933|Superiority or Other|||||||0.15|||||||Kruskal-Wallis||||
1761016|NCT00141778|3233934|Superiority or Other|||||||0.56|||||||Kruskal-Wallis||||
1761017|NCT00141778|3233935|Superiority or Other|||||||0.14|||||||Chi-squared||||
1761018|NCT00141778|3233936|Superiority or Other|||||||0.15|||||||Chi-squared||||
1761019|NCT00141778|3233937|Superiority or Other|||||||0.006|||||||Chi-squared||||
1761020|NCT00141778|3233938|Superiority or Other|||||||0.95|||||||Chi-squared|||Discrete variables were compared among treatment groups with a chi-square test.|
1761021|NCT00141739|3233941|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)|Wilcoxon rank sum test|||
1761022|NCT00141518|3233954|Superiority or Other|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1761023|NCT00141518|3233954|Superiority or Other|||||||0.208|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761024|NCT00141518|3233955|Superiority or Other|||||||0.03|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1761025|NCT00141518|3233955|Superiority or Other|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761026|NCT00141518|3233956|Superiority or Other|||||||0.073|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1761027|NCT00141518|3233956|Superiority or Other|||||||0.01|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761028|NCT00141518|3233957|Superiority or Other|||||||0.208|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1761029|NCT00141518|3233957|Superiority or Other|||||||0.026|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761033|NCT00141518|3233959|Superiority or Other|||||||0.012|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761034|NCT00141518|3233960|Superiority or Other|||||||0.847|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1761035|NCT00141518|3233960|Superiority or Other|||||||0.047|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761036|NCT00141518|3233961|Superiority or Other||||||<|0.001|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1761037|NCT00141518|3233961|Superiority or Other||||||<|0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761038|NCT00141518|3233962|Superiority or Other|||||||0.191|||||||Wilcoxon tests||||
1761039|NCT00141518|3233962|Superiority or Other|||||||0.017|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761040|NCT00141518|3233963|Superiority or Other|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1761041|NCT00141518|3233963|Superiority or Other|||||||1|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761042|NCT00141518|3233964|Superiority or Other|||||||0.003|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1761043|NCT00141518|3233964|Superiority or Other|||||||0.001|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761044|NCT00141518|3233965|Superiority or Other|||||||0.003|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1761045|NCT00141518|3233965|Superiority or Other|||||||0.048|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761046|NCT00141518|3233966|Superiority or Other|||||||0.01|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1761047|NCT00141518|3233966|Superiority or Other|||||||0.002|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761048|NCT00141518|3233967|Superiority or Other|||||||0.107|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1761049|NCT00141518|3233967|Superiority or Other|||||||0.008|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761050|NCT00141518|3233968|Superiority or Other|||||||0.188|||||||Wilcoxon tests|||Change from Baseline to Month 12 for day scores|
1761051|NCT00141518|3233968|Superiority or Other|||||||0.016|||||||Wilcoxon tests|||Change from Baseline to Month 12 for morning scores|
1761052|NCT00141518|3233977|Superiority or Other||mean change from baseline|2.3|Standard Deviation|14.9||0.534|2-Sided||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Endpoint (n=27)|
1761053|NCT00141518|3233977|Superiority or Other||mean change from baseline|4.4|Standard Deviation|14.3||0.414|2-Sided||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 36 (n=20)|
1761054|NCT00141518|3233977|Superiority or Other||mean change from baseline|0.8|Standard Deviation|13.2||0.733|2-Sided||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 30 (n=21)|
1761055|NCT00141518|3233977|Superiority or Other||mean change from baseline|-3.1|Standard Deviation|9.9||0.203|2-Sided||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 24 (n=21)|
1761056|NCT00141518|3233977|Superiority or Other||mean change from baseline|-5.2|Standard Deviation|12.3||0.049|2-Sided||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 18 (n=22)|
1761057|NCT00141518|3233977|Superiority or Other||mean change from baseline|-5.3|Standard Deviation|13.9||0.126|2-Sided||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=23)|
1761058|NCT00141518|3233977|Superiority or Other||mean change from baseline|-7.5|Standard Deviation|11.6||0.005|2-Sided||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 9 (n=23)|
1761059|NCT00141518|3233977|Superiority or Other||mean change from baseline|-5.9|Standard Deviation|11.2||0.022|2-Sided||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 6 (n=24)|
1761060|NCT00141518|3233977|Superiority or Other||mean change from baseline|-9.2|Standard Deviation|9.0|<|0.001|2-Sided||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 3 (n=23)|
1761061|NCT00141518|3233977|Superiority or Other||mean change from baseline|-6.5|Standard Deviation|9.6|<|0.001|2-Sided||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 0 (n=27)|
1761062|NCT00141518|3234004|Superiority or Other||mean change from baseline|0.18|Standard Deviation|0.24||0.002|2-Sided||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)|
1761063|NCT00141518|3234005|Superiority or Other||mean change from baseline|0.02|Standard Deviation|0.29||0.919|2-Sided||||||Wilcoxon tests|||Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)|
1761064|NCT00141518|3234006|Superiority or Other||mean change from baseline|-9.4|Standard Deviation|17.5||0.017|2-Sided||||||Wilcoxon tests|||Total Score, Change From Baseline for the Duodopa Naïve group at Month 12 (n=25)|
1761065|NCT00141453|3234009|Superiority or Other||Hazard Ratio (HR)|0.64||||0.039||95.0|0.43|0.98|||Regression, Cox|Covariates baseline urinary albumin:creatinine ratio, age and history of cardiovascular disease for cardiovascular composite event rate.|||
1761066|NCT00141453|3234010|Superiority or Other||Hazard Ratio (HR)|0.97||||0.79||95.0|0.75|1.24|||Regression, Cox|The covariates were urinary albumin:creatinine ratio and serum creatinine at baseline & regions (Japan/Hong Kong) for the renal composite event rate.||We planned to collect 400 patients to detect 35% risk reduction for renal outcome in olmesartan group with 80% power at 2-sided .05 alpha level. The Cox regression model was applied to estimate the hazard ratios (HR)between treatment groups with 95% confidence intervals for the renal and cardiovascular composite event rate.|
1761067|NCT00141271|3234061|Superiority or Other|||||||0.7737||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761068|NCT00141271|3234061|Superiority or Other|||||||0.6227||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761976|NCT00135226|3234632|Other||Rate Ratio|1.01|||||2-Sided|95.0|0.92|1.11|||||||
1761069|NCT00141271|3234062|Superiority or Other|||||||0.3654||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761070|NCT00141271|3234062|Superiority or Other|||||||0.5057||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761071|NCT00141271|3234063|Superiority or Other|||||||0.7077||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761072|NCT00141271|3234063|Superiority or Other|||||||0.2718||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761073|NCT00141271|3234064|Superiority or Other|||||||0.7037||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761074|NCT00141271|3234064|Superiority or Other|||||||0.0082||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761075|NCT00141271|3234065|Superiority or Other|||||||0.5997||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761076|NCT00141271|3234065|Superiority or Other|||||||0.1652||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761077|NCT00141271|3234066|Superiority or Other|||||||0.1958||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761078|NCT00141271|3234066|Superiority or Other|||||||0.2847||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1761079|NCT00141271|3234067|Superiority or Other|||||||0.0153||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1761080|NCT00141271|3234067|Superiority or Other|||||||0.5195||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1761081|NCT00141271|3234068|Superiority or Other|||||||0.7774||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1761082|NCT00141271|3234068|Superiority or Other|||||||0.434||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761083|NCT00141271|3234069|Superiority or Other|||||||0.2048||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761084|NCT00141271|3234069|Superiority or Other|||||||0.2763||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761085|NCT00141271|3234070|Superiority or Other|||||||0.3331||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761086|NCT00141271|3234070|Superiority or Other|||||||0.4398||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761087|NCT00141271|3234071|Superiority or Other|||||||0.4491||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761088|NCT00141271|3234071|Superiority or Other|||||||0.4749||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761089|NCT00141271|3234072|Superiority or Other|||||||0.102||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761090|NCT00141271|3234072|Superiority or Other|||||||0.7019||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761091|NCT00141271|3234073|Superiority or Other|||||||0.6727||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761092|NCT00141271|3234073|Superiority or Other|||||||0.1667||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761093|NCT00141271|3234074|Superiority or Other|||||||0.2066||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1761094|NCT00141271|3234074|Superiority or Other|||||||0.4767||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1761095|NCT00141271|3234075|Superiority or Other|||||||0.7665||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761096|NCT00141271|3234075|Superiority or Other|||||||0.1378||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761097|NCT00141271|3234076|Superiority or Other|||||||0.5971|||||||ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761098|NCT00141271|3234076|Superiority or Other|||||||0.4624||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761099|NCT00141271|3234077|Superiority or Other|||||||0.3786||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761100|NCT00141271|3234077|Superiority or Other|||||||0.9237||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761101|NCT00141271|3234078|Superiority or Other|||||||0.1374||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761102|NCT00141271|3234078|Superiority or Other|||||||0.1836||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761103|NCT00141271|3234079|Superiority or Other|||||||0.71||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761104|NCT00141271|3234079|Superiority or Other|||||||0.926||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761105|NCT00141271|3234080|Superiority or Other|||||||0.9411||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1761106|NCT00141271|3234080|Superiority or Other|||||||0.8049||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761107|NCT00141271|3234080|Superiority or Other|||||||0.6467||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1761108|NCT00141271|3234080|Superiority or Other|||||||0.6272||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1761109|NCT00141271|3234080|Superiority or Other|||||||0.6513||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3|
1761110|NCT00141271|3234080|Superiority or Other|||||||0.8598||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3|
1761111|NCT00141271|3234081|Superiority or Other|||||||0.2988||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761112|NCT00141271|3234081|Superiority or Other|||||||0.4432||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761113|NCT00141271|3234081|Superiority or Other|||||||0.129||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1761114|NCT00141271|3234081|Superiority or Other|||||||0.1151||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1761115|NCT00141271|3234081|Superiority or Other|||||||0.8737||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3|
1761116|NCT00141271|3234081|Superiority or Other|||||||0.7758||||||For all efficacy analyses, no multiple comparisons adjustments were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3|
1761508|NCT00138671|3234292|Superiority or Other||Mean Difference (Final Values)|-0.01||||||90.0|-0.27|0.26||||||Week 12|
1761117|NCT00141271|3234082|Superiority or Other|||||||0.8277||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761118|NCT00141271|3234082|Superiority or Other|||||||0.4178||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761119|NCT00141271|3234082|Superiority or Other|||||||0.4826||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1761120|NCT00141271|3234082|Superiority or Other|||||||0.8959||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1761121|NCT00141271|3234082|Superiority or Other|||||||0.8447||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3|
1761122|NCT00141271|3234082|Superiority or Other|||||||0.3355||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3|
1761123|NCT00141271|3234083|Superiority or Other|||||||0.3308||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761124|NCT00141271|3234083|Superiority or Other|||||||0.7909||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761125|NCT00141271|3234083|Superiority or Other|||||||0.2537||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1761126|NCT00141271|3234083|Superiority or Other|||||||0.287||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1761127|NCT00141271|3234083|Superiority or Other|||||||0.4023||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3|
1761128|NCT00141271|3234083|Superiority or Other|||||||0.8464||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3|
1761129|NCT00141271|3234084|Superiority or Other|||||||0.6079||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761130|NCT00141271|3234084|Superiority or Other|||||||0.5407||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761131|NCT00141271|3234085|Superiority or Other|||||||0.1915||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761132|NCT00141271|3234085|Superiority or Other|||||||0.3299||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761133|NCT00141271|3234086|Superiority or Other|||||||0.3385||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1761134|NCT00141271|3234086|Superiority or Other|||||||0.6143||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1761135|NCT00141271|3234086|Superiority or Other|||||||0.0303||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6|
1761136|NCT00141271|3234086|Superiority or Other|||||||0.5482||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6|
1761137|NCT00141271|3234086|Superiority or Other|||||||0.29||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5|
1761138|NCT00141271|3234086|Superiority or Other|||||||0.0674||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5|
1761139|NCT00141271|3234086|Superiority or Other|||||||0.1483||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4|
1761337|NCT00139776|3234223|Superiority or Other||||||<|0.1404||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Role emotional|
1761140|NCT00141271|3234086|Superiority or Other|||||||0.1144||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4|
1761141|NCT00141271|3234086|Superiority or Other|||||||0.0128||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1761142|NCT00141271|3234086|Superiority or Other|||||||0.6997||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1761143|NCT00141271|3234086|Superiority or Other|||||||0.2143||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2|
1761144|NCT00141271|3234086|Superiority or Other|||||||0.2614||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 2|
1761145|NCT00141271|3234086|Superiority or Other|||||||0.2672||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 1|
1761146|NCT00141271|3234086|Superiority or Other|||||||0.1454||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1|
1761147|NCT00141271|3234087|Superiority or Other|||||||0.6034||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761148|NCT00141271|3234087|Superiority or Other|||||||0.6298||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761149|NCT00141271|3234087|Superiority or Other|||||||0.2858||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1761150|NCT00141271|3234087|Superiority or Other|||||||0.5071||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1761151|NCT00141271|3234087|Superiority or Other|||||||0.9254||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3|
1761152|NCT00141271|3234087|Superiority or Other|||||||0.2058||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3|
1761153|NCT00141271|3234088|Superiority or Other|||||||0.1473||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Overall|
1761154|NCT00141271|3234088|Superiority or Other|||||||0.6292||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Overall|
1761155|NCT00141271|3234088|Superiority or Other|||||||0.549||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 6|
1761156|NCT00141271|3234088|Superiority or Other|||||||0.8586||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 6|
1761157|NCT00141271|3234088|Superiority or Other|||||||0.4182||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 5|
1761158|NCT00141271|3234088|Superiority or Other|||||||0.3925||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 5|
1761159|NCT00141271|3234088|Superiority or Other|||||||0.8374||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 4|
1761160|NCT00141271|3234088|Superiority or Other|||||||0.8819||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 4|
1761161|NCT00141271|3234088|Superiority or Other|||||||0.0899||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 3|
1761162|NCT00141271|3234088|Superiority or Other|||||||0.6144||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 3|
1761163|NCT00141271|3234088|Superiority or Other|||||||0.1118||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 2|
1761164|NCT00141271|3234088|Superiority or Other|||||||0.2128||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 2|
1761165|NCT00141271|3234088|Superiority or Other|||||||0.0287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 1|
1761166|NCT00141271|3234088|Superiority or Other|||||||0.6932||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 1|
1761167|NCT00141271|3234089|Superiority or Other|||||||0.3082||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Overall|
1761168|NCT00141271|3234089|Superiority or Other|||||||0.6343||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Overall|
1761169|NCT00141271|3234089|Superiority or Other|||||||0.8502||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 6|
1761170|NCT00141271|3234089|Superiority or Other|||||||0.8276||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 6|
1761171|NCT00141271|3234089|Superiority or Other|||||||0.3967||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 5|
1761172|NCT00141271|3234089|Superiority or Other|||||||0.4882||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 5|
1761173|NCT00141271|3234089|Superiority or Other|||||||0.5073||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 4|
1761174|NCT00141271|3234089|Superiority or Other|||||||0.9795||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 4|
1761175|NCT00141271|3234089|Superiority or Other|||||||0.0552||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 3|
1761176|NCT00141271|3234089|Superiority or Other|||||||0.8048||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value.||Week 3|
1761177|NCT00141271|3234089|Superiority or Other|||||||0.5093||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value.||Week 2|
1761178|NCT00141271|3234089|Superiority or Other|||||||0.4099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 2|
1761179|NCT00141271|3234089|Superiority or Other|||||||0.4481||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 1|
1761180|NCT00141271|3234089|Superiority or Other|||||||0.2878||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 1|
1761181|NCT00141271|3234090|Superiority or Other|||||||0.3153||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Overall|
1761182|NCT00141271|3234090|Superiority or Other|||||||0.9543||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Overall|
1761183|NCT00141271|3234090|Superiority or Other|||||||0.0999||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 6|
1761184|NCT00141271|3234090|Superiority or Other|||||||0.7791||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 6|
1761588|NCT00137111|3234412|Superiority or Other (legacy)|||||||9.5e-07|||||||Wilcoxon (Mann-Whitney)||||
1761185|NCT00141271|3234090|Superiority or Other|||||||0.3245||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 5|
1761186|NCT00141271|3234090|Superiority or Other|||||||0.2695||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 5|
1761187|NCT00141271|3234090|Superiority or Other|||||||0.1042||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 4|
1761188|NCT00141271|3234090|Superiority or Other|||||||0.2072||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 4|
1761189|NCT00141271|3234090|Superiority or Other|||||||0.8926||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 3|
1761190|NCT00141271|3234090|Superiority or Other|||||||0.8731||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 3|
1761191|NCT00141271|3234090|Superiority or Other|||||||0.7714||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 2|
1761192|NCT00141271|3234090|Superiority or Other|||||||0.4238||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 2|
1761193|NCT00141271|3234090|Superiority or Other|||||||0.08||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 1|
1761194|NCT00141271|3234090|Superiority or Other|||||||0.6924||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 1|
1761195|NCT00141271|3234091|Superiority or Other|||||||0.9359||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761196|NCT00141271|3234091|Superiority or Other|||||||0.6104||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761197|NCT00141271|3234091|Superiority or Other|||||||0.4099||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1761198|NCT00141271|3234091|Superiority or Other|||||||0.327||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 6|
1761199|NCT00141271|3234091|Superiority or Other|||||||0.6534||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3|
1761200|NCT00141271|3234091|Superiority or Other|||||||0.0896||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Week 3|
1761201|NCT00141271|3234092|Superiority or Other|||||||0.3586||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761202|NCT00141271|3234092|Superiority or Other|||||||0.8982||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Endpoint|
1761203|NCT00141271|3234092|Superiority or Other|||||||0.1546||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6|
1761204|NCT00141271|3234092|Superiority or Other|||||||0.3303||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 6|
1761205|NCT00141271|3234092|Superiority or Other|||||||0.5813||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3|
1761206|NCT00141271|3234092|Superiority or Other|||||||0.4869||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate.||Week 3|
1761207|NCT00141271|3234093|Superiority or Other|||||||0.7331||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1761977|NCT00135226|3234633|Other||Rate Ratio|0.75|||||2-Sided|95.0|0.17|3.31|||||||
1761208|NCT00141271|3234093|Superiority or Other|||||||0.9485||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1761209|NCT00141271|3234093|Superiority or Other|||||||0.8781||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6|
1761210|NCT00141271|3234093|Superiority or Other|||||||0.3323||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6|
1761211|NCT00141271|3234093|Superiority or Other|||||||0.3122||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1761212|NCT00141271|3234093|Superiority or Other|||||||0.3888||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1761213|NCT00141271|3234094|Superiority or Other|||||||0.9428||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1761214|NCT00141271|3234094|Superiority or Other|||||||0.9356||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1761215|NCT00141271|3234094|Superiority or Other|||||||0.5139||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 6|
1761216|NCT00141271|3234094|Superiority or Other|||||||0.3048||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups.||Week 6|
1761217|NCT00141271|3234094|Superiority or Other|||||||0.7364||||||For all secondary efficacy analyses, no multiple comparison adjustment were made.|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5|
1761218|NCT00141271|3234094|Superiority or Other|||||||0.0599||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5|
1761219|NCT00141271|3234094|Superiority or Other|||||||0.9855||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4|
1761220|NCT00141271|3234094|Superiority or Other|||||||0.8063||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4|
1761221|NCT00141271|3234094|Superiority or Other|||||||0.2564||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1761222|NCT00141271|3234094|Superiority or Other|||||||0.4765||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1761223|NCT00141271|3234094|Superiority or Other|||||||0.7107||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2|
1761224|NCT00141271|3234094|Superiority or Other|||||||0.4399||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2|
1761225|NCT00141271|3234094|Superiority or Other|||||||0.7449||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1|
1761226|NCT00141271|3234094|Superiority or Other|||||||0.2076||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1|
1761227|NCT00141271|3234095|Superiority or Other|||||||0.7041||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761228|NCT00141271|3234095|Superiority or Other|||||||0.4327||||||For all efficacy analyses, no multiple comparisons adjustments were made|ANCOVA|Model included model terms of treatment, rapid cycling, center, prior hospitalization status, as well as baseline value as a covariate||Endpoint|
1761229|NCT00141271|3234096|Superiority or Other|||||||0.7564||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1761504|NCT00138671|3234292|Superiority or Other||Mean Difference (Final Values)|0.01||||||90.0|-0.29|0.31||||||Week 52 LOCF|
1761230|NCT00141271|3234096|Superiority or Other|||||||0.7865||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1761231|NCT00141271|3234096|Superiority or Other|||||||0.6959||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6|
1761232|NCT00141271|3234096|Superiority or Other|||||||0.562||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6|
1761233|NCT00141271|3234096|Superiority or Other|||||||0.435||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1761234|NCT00141271|3234096|Superiority or Other|||||||0.8921||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1761235|NCT00141271|3234097|Superiority or Other|||||||0.5989||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1761236|NCT00141271|3234097|Superiority or Other|||||||0.6432||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Endpoint|
1761237|NCT00141271|3234097|Superiority or Other|||||||0.3228||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6|
1761238|NCT00141271|3234097|Superiority or Other|||||||0.6978||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 6|
1761239|NCT00141271|3234097|Superiority or Other|||||||0.3132||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5|
1761240|NCT00141271|3234097|Superiority or Other|||||||0.1044||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 5|
1761241|NCT00141271|3234097|Superiority or Other|||||||0.6939|||||||Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4|
1761242|NCT00141271|3234097|Superiority or Other|||||||0.8871||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 4|
1761243|NCT00141271|3234097|Superiority or Other|||||||0.1059||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1761244|NCT00141271|3234097|Superiority or Other|||||||0.5274||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 3|
1761245|NCT00141271|3234097|Superiority or Other|||||||0.7904||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2|
1761246|NCT00141271|3234097|Superiority or Other|||||||0.7401||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 2|
1761247|NCT00141271|3234097|Superiority or Other|||||||0.4734||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week1|
1761248|NCT00141271|3234097|Superiority or Other|||||||0.2287||||||For all secondary efficacy analyses, no multiple comparison adjustment were made|Cochran-Mantel-Haenszel|CMH test stratified by study center and rapid cycling strata was used to compare remission and response rates between ziprasidone and placebo groups||Week 1|
1761249|NCT00141271|3234098|Superiority or Other|||||||0.0811||||||Hochberg’s adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Overall|
1761250|NCT00141271|3234098|Superiority or Other|||||||0.529||||||Hochberg’s adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Overall|
1761269|NCT00141219|3234106|Superiority or Other||Mean Difference (Final Values)|-2.12|Standard Error of the Mean|2.044||0.3||95.0|-6.15|1.91||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Overall Sleep Problem~Pregabalin minus Placebo"|
1761505|NCT00138671|3234292|Superiority or Other||Mean Difference (Final Values)|0.06||||||90.0|-0.23|0.35||||||Week 52|
1761251|NCT00141271|3234098|Superiority or Other|||||||0.2148||||||Hochberg’s adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||"Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups."|
1761252|NCT00141271|3234098|Superiority or Other|||||||0.6608||||||Hochberg’s adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||"Week 6 An estimated sample size of 180 was needed per treatment arm in order to achieve 85% power to detect a treatment difference of 3.5 in the mean change from baseline to Week 6 in MADRS total score with a two-sided t-test at the 0.05 significance level. The common standard deviation was estimated as 11.0.~The null hypotheses for the primary parameter is equality of mean change from baseline to Week 6 in MADRS total score between ziprasidone and placebo groups."|
1761253|NCT00141271|3234098|Superiority or Other|||||||0.1897||||||Hochberg’s adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 5|
1761254|NCT00141271|3234098|Superiority or Other|||||||0.2924||||||Hochberg’s adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Hochberg’s adjustment used for multiple comparisons adjustment||Week 5|
1761255|NCT00141271|3234098|Superiority or Other|||||||0.1893||||||Hochberg’s adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 4|
1761256|NCT00141271|3234098|Superiority or Other|||||||0.9582||||||Hochberg’s adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 4|
1761257|NCT00141271|3234098|Superiority or Other|||||||0.1105||||||Hochberg’s adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 3|
1761258|NCT00141271|3234098|Superiority or Other|||||||0.8129||||||Hochberg’s adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 3|
1761259|NCT00141271|3234098|Superiority or Other|||||||0.4444||||||Hochberg’s adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 2|
1761260|NCT00141271|3234098|Superiority or Other|||||||0.484||||||Hochberg’s adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 2|
1761261|NCT00141271|3234098|Superiority or Other|||||||0.014||||||Hochberg’s adjustment used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 1|
1761262|NCT00141271|3234098|Superiority or Other|||||||0.6409||||||Hochberg’s adjustment was used for multiple comparisons adjustment|Mixed Models Analysis|Fixed categorical: treatment, rapid cycling, center, visit, prior hosp & treatment-by-visit interaction & fixed continuous effect of baseline value||Week 1|
1761263|NCT00141219|3234100|Superiority or Other|||||||0.119||||||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|"To apply CMH, each category is given a numerical score; the method of modified rdit used to assign numeric scores."||Cochran-Mantel-Haenszel (CMH) test on the null hypothesis of no treatment difference in all centers. CMH test comparing Pregabalin to Placebo adjusted for center.|
1761264|NCT00141219|3234101|Superiority or Other|||||||0.473||||||All statistical testing was 2-sided and was conducted at the 5% level of significance. p-value is from comparing Pregabalin versus Placebo.|Cochran-Mantel-Haenszel|"To apply CMH, each category is given a numerical score; the method of modified rdit used to assign numeric scores."||Cochran-Mantel-Haenszel (CMH) test on the null hypothesis of no treatment difference in all centers. CMH test comparing Pregabalin to Placebo adjusted for center.|
1761265|NCT00141219|3234102|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.438||0.664||95.0|-1.05|0.67||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Depression Score~Pregabalin minus Placebo"|
1761266|NCT00141219|3234103|Superiority or Other||Mean Difference (Final Values)|-0.85|Standard Error of the Mean|0.409||0.038||95.0|-1.66|-0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Anxiety Score~Pregabalin minus Placebo"|
1761267|NCT00141219|3234104|Superiority or Other||Mean Difference (Final Values)|3.5|Standard Error of the Mean|2.375||0.142||95.0|-1.18|8.18||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint VAS Score~Pregabalin minus Placebo"|
1761268|NCT00141219|3234105|Superiority or Other||Mean Difference (Final Values)|0.026|Standard Error of the Mean|0.0325||0.429||95.0|-0.038|0.09||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Utility Score~Pregabalin minus Placebo"|
1761334|NCT00139776|3234223|Superiority or Other|||||||0.0301||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Mental component summary|
1761270|NCT00141219|3234107|Superiority or Other||Mean Difference (Final Values)|4.71|Standard Error of the Mean|2.349||0.046||95.0|0.08|9.34||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Somnolence~Pregabalin minus Placebo"|
1761271|NCT00141219|3234108|Superiority or Other||Mean Difference (Final Values)|2.15|Standard Error of the Mean|3.796||0.571||95.0|-5.33|9.63||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Adequacy~Pregabalin minus Placebo"|
1761272|NCT00141219|3234109|Superiority or Other||Odds Ratio (OR)|1.23|Standard Error of the Mean|0.37||0.504||95.0|0.67|2.24||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Regression, Logistic|OR estimated from model with Optimal sleep status (Yes/No) as response variable, and treatment, baseline Optimal sleep status as explanatory variables|The OR estimates ratio of “Odds of optimal sleep” between Pregabalin and Placebo (ie, the former to the latter). “Odds of optimal sleep” in treatment group is ratio of “Probability of having optimal sleep” vs “Probability of Not having optimal sleep”|"Week 8 Optimal Sleep~Optimal Sleep is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.~Odds ratio measured the odds of optimal sleep in pregabalin to that in placebo.~Standard Error of the Mean equals Standard Error of the Odds Ratio (OR)."|
1761273|NCT00141219|3234110|Superiority or Other||Mean Difference (Final Values)|0.44|Standard Error of the Mean|0.182||0.018||95.0|0.08|0.8||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Quantity~Pregabalin minus Placebo"|
1761274|NCT00141219|3234111|Superiority or Other||Mean Difference (Final Values)|-3.09|Standard Error of the Mean|1.887||0.103||95.0|-6.81|0.63||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Awaken Short of Breath or Headache~Pregabalin minus Placebo"|
1761275|NCT00141219|3234112|Superiority or Other||Mean Difference (Final Values)|5.05|Standard Error of the Mean|3.309||0.128||95.0|-1.47|11.58||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Snoring Score~Pregabalin minus Placebo"|
1761276|NCT00141219|3234113|Superiority or Other||Mean Difference (Final Values)|-5.62|Standard Error of the Mean|2.639||0.034||95.0|-10.82|-0.42||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Week 8 Sleep Disturbance~Pregabalin minus Placebo"|
1761277|NCT00141219|3234114|Superiority or Other||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.252||0.015||95.0|-1.11|-0.12||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 8 Sleep Interference Score~Pregabalin minus Placebo"|
1761278|NCT00141219|3234114|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.252||0.037||95.0|-1.02|-0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 7 Sleep Interference Score~Pregabalin minus Placebo"|
1761279|NCT00141219|3234114|Superiority or Other||Mean Difference (Final Values)|-0.52|Standard Error of the Mean|0.25||0.038||95.0|-1.01|-0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 6 Sleep Interference Score~Pregabalin minus Placebo"|
1761280|NCT00141219|3234114|Superiority or Other||Mean Difference (Final Values)|-0.44|Standard Error of the Mean|0.25||0.078||95.0|-0.93|0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 5 Sleep Interference Score~Pregabalin minus Placebo"|
1761281|NCT00141219|3234114|Superiority or Other||Mean Difference (Final Values)|-0.53|Standard Error of the Mean|0.249||0.033||95.0|-1.02|-0.04||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 4 Sleep Interference Score~Pregabalin minus Placebo"|
1761282|NCT00141219|3234114|Superiority or Other||Mean Difference (Final Values)|-0.59|Standard Error of the Mean|0.248||0.017||95.0|-1.07|-0.1||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 3 Sleep Interference Score~Pregabalin minus Placebo"|
1761283|NCT00141219|3234114|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.246||0.041||95.0|-0.99|-0.02||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 2 Sleep Interference Score~Pregabalin minus Placebo"|
1761284|NCT00141219|3234114|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.245||0.12||95.0|-0.86|0.1||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 1 Sleep Interference Score~Pregabalin minus Placebo"|
1761335|NCT00139776|3234223|Superiority or Other||||||<|0.0001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Physical component summary|
1761336|NCT00139776|3234223|Superiority or Other||||||<|0.4015||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Mental health|
1761285|NCT00141219|3234114|Superiority or Other||Mean Difference (Final Values)|-0.51|Standard Error of the Mean|0.226||0.024||95.0|-0.96|-0.07||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Weeks 1 to 8 Mean Sleep Score~Overall Comparison (8-week average)~Pregabalin minus Placebo"|
1761286|NCT00141219|3234115|Superiority or Other||Mean Difference (Final Values)|-0.65|Standard Error of the Mean|0.272||0.018||95.0|-1.19|-0.11||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Endpoint Sleep Interference Score~Pregabalin minus Placebo"|
1761287|NCT00141219|3234116|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.186||0.044||95.0|-0.74|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center as factors and baseline value as a covariate.||"Duration Adjusted Average Change (DAAC)~Pregabalin minus Placebo"|
1761288|NCT00141219|3234117|Superiority or Other||Mean Difference (Final Values)|-0.45|Standard Error of the Mean|0.218||0.039||95.0|-0.88|-0.02||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 8 Mean Pain Score~Pregabalin minus Placebo"|
1761289|NCT00141219|3234117|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.218||0.104||95.0|-0.78|0.07||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 7 Mean Pain Score~Pregabalin minus Placebo"|
1761290|NCT00141219|3234117|Superiority or Other||Mean Difference (Final Values)|-0.29|Standard Error of the Mean|0.216||0.178||95.0|-0.72|0.13||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 6 Mean Pain Score~Pregabalin minus Placebo"|
1761291|NCT00141219|3234117|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.216||0.051||95.0|-0.85|0.0||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 5 Mean Pain Score~Pregabalin minus Placebo"|
1761292|NCT00141219|3234117|Superiority or Other||Mean Difference (Final Values)|-0.43|Standard Error of the Mean|0.215||0.044||95.0|-0.85|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 4 Mean Pain Score~Pregabalin minus Placebo"|
1761293|NCT00141219|3234117|Superiority or Other||Mean Difference (Final Values)|-0.41|Standard Error of the Mean|0.213||0.057||95.0|-0.82|0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 3 Mean Pain Score~Pregabalin minus Placebo"|
1761294|NCT00141219|3234117|Superiority or Other||Mean Difference (Final Values)|-0.31|Standard Error of the Mean|0.212||0.149||95.0|-0.72|0.11||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 2 Mean Pain Score~Pregabalin minus Placebo"|
1761295|NCT00141219|3234117|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.21||0.071||95.0|-0.79|0.03||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center and treatment by week interaction as factors and baseline value as a covariate.||"Week 1 Mean Pain Score~Pregabalin minus Placebo"|
1761296|NCT00141219|3234117|Superiority or Other||Mean Difference (Final Values)|-0.38|Standard Error of the Mean|0.186||0.042||95.0|-0.75|-0.01||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Linear Mixed Model|Estimated from a linear mixed model with treatment, week, center, and treatment by week interaction as factors and baseline value as a covariate.||"Mean Pain Score Weeks 1 to 8~Overall Comparison (8-week average)~Pregabalin minus Placebo"|
1761297|NCT00141219|3234118|Superiority or Other||Mean Difference (Final Values)|-0.48|Standard Error of the Mean|0.267||0.077||95.0|-1.0|0.05||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from general linear model with treatment and center fitted as factors and the baseline value as a covariate.||"Endpoint Mean Pain Score~Pregabalin minus Placebo"|
1761298|NCT00141219|3234119|Superiority or Other|||||||0.979||||||Interaction p-value based on adding interaction term to the main model.|General Linear Model|In supportive model 2, a “treatment by baseline mean pain” independent variable added to the main model.||This was a supportive analysis of the primary endpoint to determine if the main results were generalizable across different baseline values.|
1761299|NCT00141219|3234119|Superiority or Other|||||||0.729||||||Interaction p-value based on adding interaction term to the main model.|General Linear Model|In supportive model 1, a “treatment by center” independent variable added to the main model.||This was a supportive analysis of the primary endpoint to determine if the main results were generalizable across centers.|
1761300|NCT00141219|3234119|Superiority or Other||Mean Difference (Final Values)|-0.5|Standard Error of the Mean|0.252||0.049||95.0|-1.0|0.0||All statistical testing was 2-sided and was conducted at the 5% level of significance.|General Linear Model|Estimated from the general linear model with treatment and center fitted as factors and the baseline value as a covariate.||Null hypotheses stated there was no difference in pregabalin and placebo in the primary endpoint versus the alternative that there was. The target sample size was 234 subjects (156 and 78 respectively pregabalin vs placebo using a 2:1 ratio). The calculations assumed a 2-sided comparison at 0.05 alpha, 80% power and 3% dropout. Also, a treatment difference of 1 point and a standard deviation for endpoint mean pain scores of 2.5 were assumed based on previous studies.|
1761978|NCT00135226|3234633|Other||Rate Ratio|0.75|||||2-Sided|95.0|0.17|3.3|||||||
1761301|NCT00141219|3234120|Superiority or Other||Risk Ratio (RR)|1.644||||0.041||95.0|0.915|2.954||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|P-value in above table was from Cochran-Mantel-Haenszel test comparing Pregabalin and Placebo adjusted for center.|RR estimates relative responder rate between Pregabalin and Placebo (the ratio of the former responder rate to the latter). Estimated RR was center-adjusted ie, assumed common RR in all centers, then a weighted average of center specific RRs computed|Null hypothesis of no treatment difference in each of the centers.|
1761302|NCT00141219|3234121|Superiority or Other||Risk Ratio (RR)|1.115||||0.289||95.0|0.785|1.583||All statistical testing was 2-sided and was conducted at the 5% level of significance.|Cochran-Mantel-Haenszel|P-value in above table was from Cochran-Mantel-Haenszel test comparing Pregabalin and Placebo adjusted for center.|RR estimates relative responder rate between Pregabalin and Placebo (the ratio of the former responder rate to the latter). Estimated RR was center-adjusted ie, assumed common RR in all centers, then a weighted average of center specific RRs computed|Null hypothesis of no treatment difference in each of the centers.|
1761303|NCT00141102|3234126|Superiority or Other||LS Mean Difference|-0.015|Standard Error of the Mean|0.038||0.6819|2-Sided|95.0|-0.09|0.06|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.|||
1761304|NCT00141102|3234127|Superiority or Other||LS Mean Difference|-1.406|Standard Error of the Mean|2.624||0.592|2-Sided|95.0|-6.55|3.74|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.|||
1761305|NCT00141102|3234128|Superiority or Other||LS Mean Difference|0.565|Standard Error of the Mean|1.366||0.6795|2-Sided|95.0|-2.11|3.24|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.|||
1761306|NCT00141102|3234129|Superiority or Other||LS Mean Difference|-6.364|Standard Error of the Mean|0.428|<|0.0001|2-Sided|95.0|-7.2|-5.52|||ANCOVA|||ALT|
1761307|NCT00141102|3234129|Superiority or Other||LS Mean Difference|-2.391|Standard Error of the Mean|0.281|<|0.0001|2-Sided|95.0|-2.94|-1.84|||ANCOVA|||AST|
1761308|NCT00141102|3234129|Superiority or Other||LS Mean Difference|-10.144|Standard Error of the Mean|0.697|<|0.0001|2-Sided|95.0|-11.51|-8.78|||ANCOVA|||GGT|
1761309|NCT00141102|3234130|Superiority or Other||Relative Risk|2.089||||0.0264|2-Sided|95.0|1.081|4.038|||Fisher Exact|||ALT|
1761310|NCT00141102|3234130|Superiority or Other||Relative Risk|1.509||||0.3809|2-Sided|95.0|0.618|3.684|||Fisher Exact|||AST|
1761311|NCT00141102|3234130|Superiority or Other||Relative Risk|3.329|||<|0.0001|2-Sided|95.0|2.156|5.141|||Fisher Exact|||GGT|
1761312|NCT00141102|3234131|Superiority or Other||Relative Risk|2.748|||<|0.0001|2-Sided|95.0|1.96|3.84|||Cochran-Mantel-Haenszel|Stratified by history of GD ulceration and by region.|||
1761313|NCT00141102|3234132|Superiority or Other||LS Mean Difference|1.118|Standard Error of the Mean|0.069|<|0.0001|2-Sided|95.0|0.98|1.25|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.|||
1761314|NCT00141102|3234133|Superiority or Other||LS Mean Difference|0.406|Standard Error of the Mean|0.022|<|0.0001|2-Sided|95.0|0.36|0.45|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.|||
1761315|NCT00141102|3234134|Superiority or Other||Odds Ratio (OR)|1.52||||0.0006|2-Sided||||||Life Table Extension|Stratified by history of GD ulceration and by region.|||
1761316|NCT00141102|3234135|Superiority or Other||Odds Ratio (OR)|1.26||||0.0495|2-Sided||||||Life Table Extension|Stratified by history of GD ulceration and by region.|||
1761317|NCT00141102|3234137|Superiority or Other||Odds Ratio (OR)|2.29||||0.1132|2-Sided||||||Life Table Extension|Stratified by history of GD ulceration and by region.|||
1761318|NCT00141102|3234138|Superiority or Other||Least Squares (LS) Mean Difference|-0.019|Standard Error of the Mean|0.023||0.4146|2-Sided|95.0|-0.06|0.03|||ANCOVA|Fixed effects of region and history of GD ulceration with Baseline covariate.|||
1761319|NCT00141102|3234139|Superiority or Other||Odds Ratio (OR)|3.93|||<|0.0001|2-Sided||||||Life Table Extension|Stratified by history of GD ulceration and by region.|||
1761320|NCT00141102|3234140|Superiority or Other||Odds Ratio (OR)|4.32|||<|0.0001|2-Sided||||||Life Table Extension|Stratified by history of GD ulceration and by region.|||
1761321|NCT00141037|3234141|Superiority or Other|||||||0.85|||||||Fisher Exact|||The difference was analyzed using a Fisher’s exact test.|
1761322|NCT00141037|3234142|Superiority or Other|||||||0.79|||||||Wilcoxon Nonparametric Test|||The endpoint is assessed using a Wilcoxon nonparametric test and missing values are imputed using the last observation carried forward.|
1761323|NCT00140842|3234143|Superiority or Other||Mean Difference (Net)|23.7|Standard Deviation|12.0|<|0.05||95.0|||||t-test, 2 sided|||The null hypothesis is that there is no difference between the groups for visceral adipose tissue|
1761324|NCT00140842|3234144|Superiority or Other||Mean Difference (Net)|15.0|Standard Deviation|16.0|<|0.05||95.0|||||t-test, 2 sided|||The null hypothesis was that there is no difference between the groups for peak growth hormone on the growth hormone stimulation test.|
1761325|NCT00140426|3234155|Superiority or Other|||||||0.12|||||||t-test, 2 sided||||
1761326|NCT00140426|3234156|Superiority or Other|||||||0.43|||||||t-test, 2 sided||||
1761327|NCT00140426|3234157|Superiority or Other|||||||0.5|||||||t-test, 2 sided||||
1761328|NCT00140426|3234158|Superiority or Other|||||||0.57|||||||t-test, 2 sided||||
1761329|NCT00140426|3234159|Superiority or Other||Mean Difference (Final Values)|-0.19|Standard Error of the Mean|0.26||0.47|2-Sided|95.0|-0.71|0.33|||t-test, 2 sided||The mean difference was for placebo - risperidone.|Null hypothesis: no difference in change from baseline to end of treatment for CAPT total score|
1761330|NCT00140426|3234161|Superiority or Other||Mean Difference (Final Values)|-43.45|Standard Deviation|20.88|<|0.01|2-Sided||||||t-test, 2 sided||||
1761331|NCT00140426|3234161|Superiority or Other||Mean Difference (Net)|-2.38|Standard Deviation|3.74|<|0.1|2-Sided||||||t-test, 2 sided||||
1761332|NCT00140426|3234165|Superiority or Other||Hazard Ratio (HR)|0.85||||0.55|2-Sided|95.0|0.41|1.74|||Regression, Cox|Time to reaching ease of eating level 3 assessed using Cox regression as some patients did not reach it during the study.|The hazard ratio is for the placebo group versus the treatment group. A hazard ratio <1 implies that the placebo group had a lower risk of achieving EOE level 3, although not statistically significant. Achieving EOE level 3 was the desired endpoint.||
1761333|NCT00139997|3234221|Superiority or Other|||||||0.028|||||||t-test, 2 sided||||
1761338|NCT00139776|3234223|Superiority or Other||||||<|0.1303||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Social functioning|
1761339|NCT00139776|3234223|Superiority or Other||||||<|0.0139||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Vitality|
1761340|NCT00139776|3234223|Superiority or Other||||||<|0.3097||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||General health|
1761341|NCT00139776|3234223|Superiority or Other||||||<|0.0001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Bodily pain|
1761342|NCT00139776|3234223|Superiority or Other||||||<|0.0001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Role physical|
1761343|NCT00139776|3234223|Superiority or Other||||||<|0.0001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Physical function|
1761344|NCT00139776|3234224|Superiority or Other|||||||0.1437||||||Threshold for statistical significance p<0.05|Cochran-Mantel-Haenszel|by general association||Analysis across all 3 sleep scores for Period III|
1761345|NCT00139776|3234225|Superiority or Other||||||<|0.001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC physical function subscale|
1761346|NCT00139776|3234225|Superiority or Other||||||<|0.001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC stiffness subscale|
1761347|NCT00139776|3234225|Superiority or Other||||||<|0.001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC pain subscale|
1761348|NCT00139776|3234225|Superiority or Other||||||<|0.001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC total score|
1761349|NCT00139776|3234226|Superiority or Other|||||||0.5878||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep problems index II|
1761350|NCT00139776|3234226|Superiority or Other|||||||0.8358||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep problems index I|
1761351|NCT00139776|3234226|Superiority or Other|||||||0.5854||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Somnolence|
1761352|NCT00139776|3234226|Superiority or Other|||||||0.4075||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep adequacy|
1761353|NCT00139776|3234226|Superiority or Other|||||||0.3769||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Quantity of sleep|
1761354|NCT00139776|3234226|Superiority or Other|||||||0.7703||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Awaken short of breath|
1761355|NCT00139776|3234226|Superiority or Other|||||||0.8737||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Snoring|
1761356|NCT00139776|3234226|Superiority or Other|||||||0.2712||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Sleep disturbance|
1761357|NCT00139776|3234227|Superiority or Other||Mean Difference (Final Values)|3.43|Standard Error of the Mean|0.51||||95.0|2.42|4.43|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC physical function subscale - Intermittent use|
1761358|NCT00139776|3234227|Superiority or Other||Mean Difference (Final Values)|1.13|Standard Error of the Mean|0.51||||95.0|0.13|2.14|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC physical function subscale - Continuous use|
1761359|NCT00139776|3234227|Superiority or Other|||||||0.002||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC physical function subscale|
1761360|NCT00139776|3234227|Superiority or Other||Mean Difference (Final Values)|0.4|Standard Error of the Mean|0.07||||95.0|0.26|0.53|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC stiffness subscale - Intermittent use|
1761361|NCT00139776|3234227|Superiority or Other||Mean Difference (Final Values)|0.12|Standard Error of the Mean|0.07||||95.0|-0.02|0.25|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC stiffness subscale - Continuous use|
1761362|NCT00139776|3234227|Superiority or Other|||||||0.004||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC stiffness subscale|
1761363|NCT00139776|3234227|Superiority or Other||Mean Difference (Final Values)|1.18|Standard Error of the Mean|0.15||||95.0|0.88|1.49|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC pain subscale - Intermittent use|
1761364|NCT00139776|3234227|Superiority or Other||Mean Difference (Final Values)|0.37|Standard Error of the Mean|0.15||||95.0|0.06|0.67|||||Change in LSmean (score at end of Period III minus score at start of Period III)|WOMAC pain subscale - Continuous use|
1761365|NCT00139776|3234227|Superiority or Other||||||<|0.001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||WOMAC pain subscale|
1761366|NCT00139776|3234227|Superiority or Other||Mean Difference (Final Values)|4.99|Standard Error of the Mean|0.71|<|||95.0|3.6|6.38|||||Change in LSmean (score at end of Period III minus score at start of Period III)|Total WOMAC score - Intermittent use|
1761367|NCT00139776|3234227|Superiority or Other||Mean Difference (Final Values)|1.6|Standard Error of the Mean|0.71|<|||95.0|0.21|2.99|||||Change in LSmean (score at end of Period III minus score at start of Period III)|Total WOMAC score - Continuous use|
1761368|NCT00139776|3234227|Superiority or Other||||||<|0.001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Total WOMAC score|
1761369|NCT00139776|3234228|Superiority or Other||||||<|0.0001||||||Threshold for statistical significance p<0.05|ANOVA|Treatment as fixed effect|||
1761370|NCT00139776|3234229|Superiority or Other|||||||0.0012||||||Threshold for statistical significance p<0.05|ANOVA|Treatment as fixed effect|||
1761371|NCT00139776|3234230|Superiority or Other|||||||0.0102||||||Threshold for statistical significance p<0.05|ANOVA|Treatment as fixed effect|||
1761372|NCT00139776|3234231|Superiority or Other|||||||0.0046||||||Overall p-value Threshold for statistical significance p<0.05|Cochran-Mantel-Haenszel|Test of row mean score differences based on modified ridits (standardizing the mid-rank)|||
1761373|NCT00139776|3234232|Superiority or Other|||||||0.972||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 24|
1761374|NCT00139776|3234232|Superiority or Other|||||||0.832||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 20|
1761375|NCT00139776|3234232|Superiority or Other|||||||0.338||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 16|
1761376|NCT00139776|3234232|Superiority or Other|||||||0.096||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 12|
1761377|NCT00139776|3234232|Superiority or Other|||||||0.001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 8|
1761378|NCT00139776|3234232|Superiority or Other||||||<|0.001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 4|
1761379|NCT00139776|3234233|Superiority or Other|||||||0.047||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 24|
1761380|NCT00139776|3234233|Superiority or Other|||||||0.022||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 20|
1761381|NCT00139776|3234233|Superiority or Other|||||||0.003||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 16|
1761382|NCT00139776|3234233|Superiority or Other||||||<|0.001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 12|
1761383|NCT00139776|3234233|Superiority or Other||||||<|0.001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 8|
1761384|NCT00139776|3234233|Superiority or Other||||||<|0.001||||||Threshold for statistical significance p<0.05|ANCOVA|Treatment as fixed effect and baseline as covariate||Week 4|
1761385|NCT00139776|3234234|Superiority or Other||||||<|0.0001||||||Threshold for statistical significance p<0.05|ANOVA|Treatment as fixed effect|||
1761386|NCT00139776|3234235|Superiority or Other||||||<|0.0001||||||Threshold for statistical significance p<0.05|ANOVA|Treatment as fixed effect|||
1761387|NCT00139776|3234236|Superiority or Other||||||<|0.0001||||||Threshold for statistical significance p<0.05|Log Rank|||Kaplan-Meier analysis|
1761388|NCT00139776|3234237|Superiority or Other||||||<|0.0001||||||Threshold for statistical significance p<0.05|ANOVA|Treatment as fixed effect||"Null hypothesis for primary outcome is that there is no difference in the number of flares observed between the 2 treatment arms of celecoxib 200mg continuous use and celecoxib 200mg intermittent use.~Sample size calculation: Sufficient number of participants were randomized to provide at least 80% power to detect an estimated effect size of 0.2 using a 2-sided t-test at a 0.05 significant level."|
1761389|NCT00139659|3234239|Superiority or Other||Mean Difference (Final Values)|-0.765|Standard Error of the Mean|0.212||||90.0|-1.116|-0.415||||||Week 52 Last Observation Carried Forward (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761390|NCT00139659|3234239|Superiority or Other||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|0.219||||90.0|-1.04|-0.32||||||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761391|NCT00139659|3234239|Superiority or Other||Mean Difference (Final Values)|-0.707|Standard Error of the Mean|0.212||||90.0|-1.056|-0.358||||||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761392|NCT00139659|3234239|Superiority or Other||Mean Difference (Final Values)|-0.412|Standard Error of the Mean|0.204||||90.0|-0.749|-0.076||||||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761393|NCT00139659|3234239|Superiority or Other||Mean Difference (Final Values)|-0.509|Standard Error of the Mean|0.204||||90.0|-0.845|-0.174||||||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761394|NCT00139659|3234239|Superiority or Other||Mean Difference (Final Values)|-0.533|Standard Error of the Mean|0.202||||90.0|-0.866|-0.2||||||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761395|NCT00139659|3234239|Superiority or Other||Mean Difference (Final Values)|-0.474|Standard Error of the Mean|0.196||||90.0|-0.797|-0.152||||||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761396|NCT00139659|3234239|Superiority or Other||Mean Difference (Final Values)|-0.516|Standard Error of the Mean|0.198||||90.0|-0.842|-0.191||||||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761397|NCT00139659|3234239|Superiority or Other||Mean Difference (Final Values)|-0.384|Standard Error of the Mean|0.196||||90.0|-0.707|-0.061||||||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761506|NCT00138671|3234292|Superiority or Other||Mean Difference (Final Values)|-0.08||||||90.0|-0.36|0.2||||||Week 39|
1761398|NCT00139659|3234239|Superiority or Other||Mean Difference (Final Values)|-0.336|Standard Error of the Mean|0.198||||90.0|-0.661|-0.011||||||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761399|NCT00139659|3234239|Superiority or Other||Mean Difference (Final Values)|-0.279|Standard Error of the Mean|0.199||||90.0|-0.606|0.048||||||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761400|NCT00139659|3234240|Superiority or Other||Mean Difference (Final Values)|-0.05|Standard Error of the Mean|0.028||||90.0|-0.097|-0.003||||||Week 52 Last Observation Carried Forward (LOCF; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761401|NCT00139659|3234240|Superiority or Other||Mean Difference (Final Values)|-0.065|Standard Error of the Mean|0.027||||90.0|-0.109|-0.022||||||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761402|NCT00139659|3234240|Superiority or Other||Mean Difference (Final Values)|-0.042|Standard Error of the Mean|0.026||||90.0|-0.085|0.0||||||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761403|NCT00139659|3234240|Superiority or Other||Mean Difference (Final Values)|-0.014|Standard Error of the Mean|0.025||||90.0|-0.055|0.027||||||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761404|NCT00139659|3234240|Superiority or Other||Mean Difference (Final Values)|-0.021|Standard Error of the Mean|0.025||||90.0|-0.062|0.02||||||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761405|NCT00139659|3234240|Superiority or Other||Mean Difference (Final Values)|-0.023|Standard Error of the Mean|0.024||||90.0|-0.063|0.017||||||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761406|NCT00139659|3234240|Superiority or Other||Mean Difference (Final Values)|-0.046|Standard Error of the Mean|0.024||||90.0|-0.085|-0.007||||||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761407|NCT00139659|3234240|Superiority or Other||Mean Difference (Final Values)|-0.046|Standard Error of the Mean|0.024||||90.0|-0.085|-0.007||||||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761408|NCT00139659|3234240|Superiority or Other||Mean Difference (Final Values)|-0.045|Standard Error of the Mean|0.024||||90.0|-0.084|-0.006||||||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761409|NCT00139659|3234240|Superiority or Other||Mean Difference (Final Values)|-0.029|Standard Error of the Mean|0.024||||90.0|-0.068|0.01||||||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761410|NCT00139659|3234240|Superiority or Other||Mean Difference (Final Values)|-0.039|Standard Error of the Mean|0.024||||90.0|-0.079|0.0||||||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (primary analysis model) includes terms of Treatment, Week, Baseline pulmonary function test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761411|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-0.43|Standard Error of the Mean|0.526||||90.0|-1.298|0.438||||||Week 52 (LOCF); adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761412|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-0.193|Standard Error of the Mean|0.469||||90.0|-0.964|0.579||||||Week 52; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761413|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|0.063|Standard Error of the Mean|0.552||||90.0|-0.847|0.972||||||Week 51; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761414|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-1.322|Standard Error of the Mean|1.027||||90.0|-3.012|0.369||||||Week 50; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761415|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-0.537|Standard Error of the Mean|0.451||||90.0|-1.279|0.205||||||Week 39; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761416|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-0.663|Standard Error of the Mean|0.448||||90.0|-1.4|0.075||||||Week 26; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761417|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-0.98|Standard Error of the Mean|0.453||||90.0|-1.725|-0.234||||||Week 18; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761418|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-0.891|Standard Error of the Mean|0.451||||90.0|-1.634|-0.149||||||Week 12; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761419|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-1.053|Standard Error of the Mean|0.886||||90.0|-2.51|0.405||||||Week 11; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761420|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-0.748|Standard Error of the Mean|0.467||||90.0|-1.517|0.022||||||Week 9; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761421|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-0.558|Standard Error of the Mean|0.447||||90.0|-1.294|0.178||||||Week 6; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761422|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-0.189|Standard Error of the Mean|0.449||||90.0|-0.929|0.55||||||Week 4; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761423|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-0.185|Standard Error of the Mean|0.454||||90.0|-0.931|0.562||||||Week 3; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761424|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-0.475|Standard Error of the Mean|0.461||||90.0|-1.233|0.284||||||Week 2; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761425|NCT00139659|3234248|Superiority or Other||Mean Difference (Final Values)|-1.08|Standard Error of the Mean|0.455||||90.0|-1.829|-0.331||||||Week 1; adjusted mean difference between inhaled insulin and subcutaneous insulin groups. Primary analysis model includes terms of Treatment, Week, Baseline Body Weight, Center, and Type of Diabetes.|
1761426|NCT00139659|3234249|Superiority or Other||Mean Difference (Final Values)|4.247|Standard Error of the Mean|7.816||||90.0|-8.664|17.157||||||Week 52 (LOCF); Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.|
1761427|NCT00139659|3234249|Superiority or Other||Mean Difference (Final Values)|1.149|Standard Error of the Mean|7.991||||90.0|-12.01|14.307||||||Week 52; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.|
1761428|NCT00139659|3234249|Superiority or Other||Mean Difference (Final Values)|1.828|Standard Error of the Mean|7.888||||90.0|-11.16|14.817||||||Week 39; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.|
1761429|NCT00139659|3234249|Superiority or Other||Mean Difference (Final Values)|-4.622|Standard Error of the Mean|7.897||||90.0|-17.63|8.382||||||Week 26; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.|
1761430|NCT00139659|3234249|Superiority or Other||Mean Difference (Final Values)|-6.942|Standard Error of the Mean|7.804||||90.0|-19.79|5.909||||||Week 12; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.|
1761431|NCT00139659|3234249|Superiority or Other||Mean Difference (Final Values)|10.615|Standard Error of the Mean|7.874||||90.0|-2.351|23.581||||||Week 6; Analysis of change from Baseline in fasting plasma glucose: Inhaled Insulin - Subcutaneouas Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline, Fasting Plasma Glucose, Center, and Type of Diabetes.|
1761432|NCT00139659|3234250|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.12||||90.0|-0.19|0.22||||||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.|
1761433|NCT00139659|3234250|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.11||||90.0|-0.12|0.24||||||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.|
1761434|NCT00139659|3234250|Superiority or Other||Mean Difference (Final Values)|0.14|Standard Error of the Mean|0.11||||90.0|-0.03|0.32||||||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.|
1761435|NCT00139659|3234250|Superiority or Other||Mean Difference (Final Values)|0.17|Standard Error of the Mean|0.11||||90.0|-0.01|0.34||||||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.|
1761436|NCT00139659|3234250|Superiority or Other||Mean Difference (Final Values)|0.21|Standard Error of the Mean|0.1||||90.0|0.04|0.38||||||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.|
1761437|NCT00139659|3234250|Superiority or Other||Mean Difference (Final Values)|0.11|Standard Error of the Mean|0.1||||90.0|-0.06|0.28||||||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of treatment, Week, Baseline HbA1c, Center, and Type of Diabetes.|
1761979|NCT00135226|3234634|Other||Rate ratio|0.77|||||2-Sided|95.0|0.41|1.45|||||||
1761438|NCT00139659|3234254|Superiority or Other||Mean Difference (Final Values)|-0.503|Standard Error of the Mean|0.216||||90.0|-0.858|-0.148|||||Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.|Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.|
1761439|NCT00139659|3234268|Superiority or Other||Mean Difference (Final Values)|-0.503|Standard Error of the Mean|0.711||||90.0|-1.673|0.668||||||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761440|NCT00139659|3234268|Superiority or Other||Mean Difference (Final Values)|-0.24|Standard Error of the Mean|0.694||||90.0|-1.382|0.902||||||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761441|NCT00139659|3234268|Superiority or Other||Mean Difference (Final Values)|0.044|Standard Error of the Mean|0.683||||90.0|-1.08|1.169||||||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761442|NCT00139659|3234268|Superiority or Other||Mean Difference (Final Values)|0.212|Standard Error of the Mean|0.675||||90.0|-0.899|1.323||||||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761443|NCT00139659|3234268|Superiority or Other||Mean Difference (Final Values)|-0.905|Standard Error of the Mean|0.674||||90.0|-2.014|0.203||||||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761444|NCT00139659|3234268|Superiority or Other||Mean Difference (Final Values)|-0.535|Standard Error of the Mean|0.694||||90.0|-1.677|0.608||||||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761445|NCT00139659|3234268|Superiority or Other||Mean Difference (Final Values)|-0.054|Standard Error of the Mean|0.687||||90.0|-1.184|1.077||||||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761446|NCT00139659|3234268|Superiority or Other||Mean Difference (Final Values)|0.582|Standard Error of the Mean|0.679||||90.0|-0.535|1.7||||||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761447|NCT00139659|3234268|Superiority or Other||Mean Difference (Final Values)|0.02|Standard Error of the Mean|0.668||||90.0|-1.079|1.12||||||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761448|NCT00139659|3234268|Superiority or Other||Mean Difference (Final Values)|-0.632|Standard Error of the Mean|0.697||||90.0|-1.778|0.514||||||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761449|NCT00139659|3234269|Superiority or Other||Mean Difference (Final Values)|-0.015|Standard Error of the Mean|0.031||||90.0|-0.067|0.037||||||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761450|NCT00139659|3234269|Superiority or Other||Mean Difference (Final Values)|-0.015|Standard Error of the Mean|0.03||||90.0|-0.064|0.034||||||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761451|NCT00139659|3234269|Superiority or Other||Mean Difference (Final Values)|-0.022|Standard Error of the Mean|0.029||||90.0|-0.07|0.026||||||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761452|NCT00139659|3234269|Superiority or Other||Mean Difference (Final Values)|-0.005|Standard Error of the Mean|0.028||||90.0|-0.051|0.041||||||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761453|NCT00139659|3234269|Superiority or Other||Mean Difference (Final Values)|0.018|Standard Error of the Mean|0.028||||90.0|-0.028|0.064||||||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761454|NCT00139659|3234269|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.028||||90.0|-0.035|0.056||||||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761507|NCT00138671|3234292|Superiority or Other||Mean Difference (Final Values)|-0.02||||||90.0|-0.29|0.26||||||Week 26|
1761455|NCT00139659|3234269|Superiority or Other||Mean Difference (Final Values)|-0.045|Standard Error of the Mean|0.027||||90.0|-0.089|-0.001||||||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761456|NCT00139659|3234269|Superiority or Other||Mean Difference (Final Values)|-0.004|Standard Error of the Mean|0.027||||90.0|-0.048|0.041||||||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761457|NCT00139659|3234269|Superiority or Other||Mean Difference (Final Values)|-0.012|Standard Error of the Mean|0.027||||90.0|-0.056|0.032||||||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761458|NCT00139659|3234269|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.027||||90.0|-0.044|0.044||||||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761459|NCT00139659|3234269|Superiority or Other||Mean Difference (Final Values)|-0.021|Standard Error of the Mean|0.027||||90.0|-0.066|0.023||||||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model): includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761460|NCT00139659|3234272|Superiority or Other||Mean Difference (Final Values)|-0.786|Standard Error of the Mean|0.238||||90.0|-1.178|-0.393||||||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761461|NCT00139659|3234272|Superiority or Other||Mean Difference (Final Values)|-0.789|Standard Error of the Mean|0.238||||90.0|-1.181|-0.397||||||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761462|NCT00139659|3234272|Superiority or Other||Mean Difference (Final Values)|-0.337|Standard Error of the Mean|0.231||||90.0|-0.717|0.042||||||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761463|NCT00139659|3234272|Superiority or Other||Mean Difference (Final Values)|-0.42|Standard Error of the Mean|0.224||||90.0|-0.788|-0.052||||||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761464|NCT00139659|3234272|Superiority or Other||Mean Difference (Final Values)|-0.291|Standard Error of the Mean|0.221||||90.0|-0.655|0.073||||||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761465|NCT00139659|3234272|Superiority or Other||Mean Difference (Final Values)|-0.36|Standard Error of the Mean|0.219||||90.0|-0.721|0.001||||||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761466|NCT00139659|3234272|Superiority or Other||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.213||||90.0|-0.96|-0.26||||||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761467|NCT00139659|3234272|Superiority or Other||Mean Difference (Final Values)|-0.496|Standard Error of the Mean|0.213||||90.0|-0.847|-0.145||||||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761468|NCT00139659|3234272|Superiority or Other||Mean Difference (Final Values)|-0.346|Standard Error of the Mean|0.213||||90.0|-0.696|0.004||||||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761469|NCT00139659|3234272|Superiority or Other||Mean Difference (Final Values)|-0.378|Standard Error of the Mean|0.213||||90.0|-0.729|-0.027||||||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761470|NCT00139659|3234272|Superiority or Other||Mean Difference (Final Values)|-0.327|Standard Error of the Mean|0.214||||90.0|-0.679|0.026||||||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761471|NCT00139659|3234273|Superiority or Other||Mean Difference (Final Values)|-0.061|Standard Error of the Mean|0.028||||90.0|-0.108|-0.015||||||Week 52 (LOCF); Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761472|NCT00139659|3234273|Superiority or Other||Mean Difference (Final Values)|-0.073|Standard Error of the Mean|0.027||||90.0|-0.117|-0.029||||||Week 52; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761980|NCT00135226|3234634|Other||Rate Ratio|0.86|||||2-Sided|95.0|0.46|1.6|||||||
1761473|NCT00139659|3234273|Superiority or Other||Mean Difference (Final Values)|-0.025|Standard Error of the Mean|0.026||||90.0|-0.068|0.017||||||Week 39; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761474|NCT00139659|3234273|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.025||||90.0|-0.052|0.031||||||Week 26; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761475|NCT00139659|3234273|Superiority or Other||Mean Difference (Final Values)|-0.018|Standard Error of the Mean|0.025||||90.0|-0.059|0.023||||||Week 18; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761476|NCT00139659|3234273|Superiority or Other||Mean Difference (Final Values)|-0.033|Standard Error of the Mean|0.025||||90.0|-0.073|0.008||||||Week 12; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761477|NCT00139659|3234273|Superiority or Other||Mean Difference (Final Values)|-0.027|Standard Error of the Mean|0.024||||90.0|-0.067|0.012||||||Week 6; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761478|NCT00139659|3234273|Superiority or Other||Mean Difference (Final Values)|-0.035|Standard Error of the Mean|0.024||||90.0|-0.075|0.004||||||Week 4; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761479|NCT00139659|3234273|Superiority or Other||Mean Difference (Final Values)|-0.024|Standard Error of the Mean|0.024||||90.0|-0.063|0.016||||||Week 3; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761480|NCT00139659|3234273|Superiority or Other||Mean Difference (Final Values)|-0.034|Standard Error of the Mean|0.024||||90.0|-0.073|0.006||||||Week 2; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761481|NCT00139659|3234273|Superiority or Other||Mean Difference (Final Values)|-0.025|Standard Error of the Mean|0.024||||90.0|-0.065|0.015||||||Week 1; Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Week, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on Day of Randomization.|
1761482|NCT00139659|3234274|Superiority or Other||Mean Difference (Final Values)|-0.034|Standard Error of the Mean|0.028||||90.0|-0.08|0.011|||||Primary analysis model includes terms of Treatment, Time, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, Baseline Height, Type of Diabetes, and Controller Medications Use on day of randomization.|Treatment group difference (Exubera minus subcutaneous insulin): annualized rate of change over time. Longitudinal data analysis methods with random effects were used to model the pulmonary function test (PFT) measurements. Random effects included the intercept and slope with respect to time (visit); all remaining effects were fixed. The estimated rate of change over time for each treatment group was derived from this model.|
1761483|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|-1.451||||||90.0|-3.003|0.101||||||Week 52 LOCF|
1761484|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|-2.026||||||90.0|-3.384|-0.668||||||Week 52|
1761485|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|-1.801||||||90.0|-3.204|-0.397||||||Week 51|
1761486|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|-2.116||||||90.0|-3.829|-0.403||||||Week 50|
1761487|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|-1.664||||||90.0|-2.968|-0.36||||||Week 39|
1761488|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|-0.869||||||90.0|-2.123|0.384||||||Week 26|
1761489|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|-0.309||||||90.0|-1.551|0.934||||||Week 18|
1761490|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|0.091||||||90.0|-1.127|1.308||||||Week 12|
1761491|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|0.019||||||90.0|-1.416|1.454||||||Week 11|
1761492|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|0.416||||||90.0|-0.809|1.641||||||Week 9|
1761493|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|0.562||||||90.0|-0.642|1.766||||||Week 6|
1761494|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|0.405||||||90.0|-0.793|1.602||||||Week 4|
1761495|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|0.382||||||90.0|-0.815|1.579||||||Week 3|
1761496|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|0.47||||||90.0|-0.728|1.668||||||Week 2|
1761497|NCT00138671|3234290|Superiority or Other||Mean Difference (Final Values)|0.884||||||90.0|-0.317|2.084||||||Week 1|
1761498|NCT00138671|3234291|Superiority or Other||Mean Difference (Final Values)|1.406||||||90.0|-13.7|16.514||||||Week 52 LOCF|
1761499|NCT00138671|3234291|Superiority or Other||Mean Difference (Final Values)|-8.329||||||90.0|-29.27|12.616||||||Week 52|
1761500|NCT00138671|3234291|Superiority or Other||Mean Difference (Final Values)|-8.222||||||90.0|-28.52|12.075||||||Week 39|
1761501|NCT00138671|3234291|Superiority or Other||Mean Difference (Final Values)|-22.84||||||90.0|-42.51|-3.166||||||Week 26|
1761502|NCT00138671|3234291|Superiority or Other||Mean Difference (Final Values)|-10.91||||||90.0|-30.04|8.232||||||Week 12|
1761503|NCT00138671|3234291|Superiority or Other||Mean Difference (Final Values)|-4.475||||||90.0|-23.47|14.518||||||Week 6|
1761981|NCT00135226|3234635|Other||Rate Ratio|1.26|||||2-Sided|95.0|1.0|1.59|||||||
1761509|NCT00138671|3234292|Superiority or Other||Mean Difference (Final Values)|0.1||||||90.0|-0.17|0.36||||||Week 6|
1761510|NCT00138424|3234318|Superiority or Other||Spearman Correlation|0.2||||0.75|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC12 parameter|
1761511|NCT00138424|3234318|Superiority or Other||Spearman Correlation|0.2||||0.75|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC12 parameter|
1761512|NCT00138424|3234318|Superiority or Other||Spearman Correlation|0.52||||0.18|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC12 parameter|
1761513|NCT00138424|3234318|Superiority or Other||Spearman Correlation|0.12||||0.78|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC12 parameter|
1761514|NCT00138424|3234318|Superiority or Other||Spearman Correlation|0.87||||0.05|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC4 parameter|
1761515|NCT00138424|3234318|Superiority or Other||Spearman Correlation|-0.41||||0.49|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC4 parameter|
1761516|NCT00138424|3234318|Superiority or Other||Spearman Correlation|0.31||||0.46|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK AUC4 parameter|
1761517|NCT00138424|3234318|Superiority or Other||Spearman Correlation|0.07||||0.87|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK AUC4 parameter|
1761518|NCT00138424|3234319|Superiority or Other||Spearman Correlation|0.8||||0.1|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK Cmax parameter|
1761519|NCT00138424|3234319|Superiority or Other||Spearman Correlation|-0.3||||0.62|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK Cmax parameter|
1761520|NCT00138424|3234319|Superiority or Other||Spearman Correlation|0.26||||0.53|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in urine vs the PK Cmax parameter|
1761521|NCT00138424|3234319|Superiority or Other||Spearman Correlation|0.24||||0.57|||||||Spearman Correlation|||Spearman correlation co-efficient utilized to determine viral load changes in plasma vs the PK Cmax parameter|
1761522|NCT00138294|3234335|Other||Incidence Rate Ratio|0.75|||||2-Sided|95.0|0.73|0.76||||||Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)|
1761523|NCT00138294|3234336|Other||Incidence Rate Ratio|0.69|||||2-Sided|95.0|0.67|0.71||||||Overall Effectiveness against MAARI during the Epidemic Period (2008-2009)|
1761524|NCT00138294|3234337|Other||Incidence Rate Ratio|0.89|||||2-Sided|95.0|0.87|0.91||||||Overall Effectiveness against MAARI during the Epidemic Period (2007-2008)|
1761525|NCT00137969|3234355|Superiority or Other|||||||0.6202|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)|
1761526|NCT00137969|3234356|Superiority or Other|||||||0.1277|||||||ANCOVA|||Stratified by randomization factors (race and initial prednisone dose)|
1761527|NCT00137969|3234357|Superiority or Other|||||||0.8979|||||||Log Rank|||Stratified by randomization factors (race and initial prednisone dose)|
1761528|NCT00137969|3234358|Superiority or Other|||||||0.5602|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)|
1761529|NCT00137969|3234359|Superiority or Other|||||||0.9069|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)|
1761530|NCT00137969|3234360|Superiority or Other|||||||0.4318|||||||Cochran-Mantel-Haenszel|||Stratified by randomization factors (race and initial prednisone dose)|
1761531|NCT00137969|3234361|Superiority or Other|||||||0.823|||||||Wilcoxon (Mann-Whitney)|||Stratified by randomization factors (race and initial prednisone dose)|
1761532|NCT00137969|3234362|Superiority or Other|||||||0.4875||||||One-sided p-value.|Wilcoxon (Mann-Whitney)|||Stratified by randomization factors (race and initial prednisone dose)|
1761533|NCT00137631|3234367|Superiority or Other||Rate Ratio|0.8|||<|0.05||95.0|0.42|1.53|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)|||
1761534|NCT00137631|3234368|Superiority or Other||Rate Ratio|0.49|||<|0.05||95.0|0.28|0.87|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)|||
1761535|NCT00137631|3234369|Superiority or Other||Odds Ratio (OR)|1.17|||<|0.05||95.0|0.69|1.98|||Mixed Models Analysis||||
1761536|NCT00137631|3234370|Superiority or Other||Odds Ratio (OR)|1.33|||<|0.05||95.0|1.05|1.68|||generalized estimating equations|Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)|||
1761537|NCT00137631|3234371|Superiority or Other||Rate Ratio|0.58|||<|0.05||95.0|0.33|1.01|||negative binomial regression||||
1761538|NCT00137449|3234375|Superiority or Other||1 year survival rate|69.7||||||95.0|56.3|79.7|||||||
1761539|NCT00137449|3234375|Superiority or Other||1 year survival rate|79.7||||||95.0|60.3|90.3|||||||
1761540|NCT00137449|3234375|Superiority or Other||1 year survival rate|60.0||||||95.0|40.5|75.0|||||||
1761541|NCT00137449|3234377|Superiority or Other||median|42.1||||||95.0|26.1|65.9||||||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.|
1761542|NCT00137449|3234377|Superiority or Other||median|42.1||||||95.0|26.1|65.9||||||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.|
1761543|NCT00137449|3234377|Superiority or Other||median|57.0||||||95.0|24.1|73.1||||||95% CI calculated based on the method of Brookmeyer and Crowley.Time to progression in weeks reported as median.|
1761544|NCT00137449|3234378|Superiority or Other||median|33.6||||||95.0|24.1|49.0||||||95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.|
1761545|NCT00137449|3234378|Superiority or Other||median|35.1||||||95.0|24.4|51.6||||||95% CI calculated based on the method of Brookmeyer and Crowley.Median reported is progression free survival weeks.|
1761546|NCT00137449|3234378|Superiority or Other||median|27.0||||||95.0|22.0|73.1||||||95% CI calculated based on the method of Brookmeyer and Crowley. Median reported is progression free survival weeks.|
1761547|NCT00137449|3234380|Superiority or Other||ORR rate (percentage)|13.3||||||95.0|5.9|24.6|||||PR or CR responding tumor measurements confirmed by repeat studies performed at > 4 weeks after the criteria for response first met.||
1761548|NCT00137449|3234380|Superiority or Other||ORR rate (percentage)|16.7||||||95.0|5.6|34.7|||||PR or CR responding tumor measurements confirmed by repeat studies performed at > 4 weeks after the criteria for response first met.||
1761549|NCT00137449|3234380|Superiority or Other||ORR rate (percentage)|10.0||||||95.0|2.1|26.5|||||PR or CR responding tumor measurements confirmed by repeat studies performed at > 4 weeks after the criteria for response first met.||
1761550|NCT00137449|3234382|Superiority or Other||CBR Rate (percentage)|53.3||||||95.0|40.0|66.3||||||Null hypothesis that the true CBR <=20% vs the alternative hypothesis that the true clinical benefit rate is at least 35%. The sample size is determined using a single-stage design with an alpha level of 10% & 90% power. If >=17 CR, PR or SD for at least 24 weeks are observed, null hypothesis can be rejected with a 20% target false positive error rate. If <= 16 CR, PR,or SD for at least 24 weeks are observed, null hypothesis can not be rejected with a target false negative error rate of 10%.|
1761551|NCT00137449|3234382|Superiority or Other||CBR Rate (percentage)|56.7||||||95.0|37.4|74.5|||||||
1761552|NCT00137449|3234382|Superiority or Other||CBR Rate (percentage)|50.0||||||95.0|31.3|68.7|||||||
1761553|NCT00137436|3234387|Superiority or Other|||||||0.296|||||||Wilcoxon rank-sum test|||C3.D14 : C1D1|
1761554|NCT00137436|3234387|Superiority or Other|||||||0.687|||||||Wilcoxon rank-sum test|||C2.D14 : C1D1|
1761555|NCT00137436|3234387|Superiority or Other|||||||0.434|||||||Wilcoxon rank-sum test|||C2.D1 : C1D1|
1761556|NCT00137436|3234387|Superiority or Other|||||||0.903|||||||Wilcoxon rank-sum test|||C1D14 : C1D1|
1761557|NCT00137436|3234388|Superiority or Other|||||||0.296|||||||Wilcoxon rank-sum test|||C3.D14 : C1D1|
1761558|NCT00137436|3234388|Superiority or Other|||||||0.42|||||||Wilcoxon rank-sum test|||C2.D14 : C1D1|
1761559|NCT00137436|3234388|Superiority or Other|||||||0.628|||||||Wilcoxon rank-sum test|||C2.D1 : C1D1|
1761560|NCT00137436|3234388|Superiority or Other|||||||0.656|||||||Wilcoxon rank-sum test|||C1D14 : C1D1|
1761561|NCT00137436|3234389|Superiority or Other|||||||0.164|||||||Wilcoxon rank-sum test|||C3.D14 : C1D1|
1761562|NCT00137436|3234389|Superiority or Other|||||||0.788|||||||Wilcoxon rank-sum test|||C2.D14 : C1D1|
1761563|NCT00137436|3234389|Superiority or Other|||||||0.219|||||||Wilcoxon rank-sum test|||C2.D1 : C1D1|
1761564|NCT00137436|3234389|Superiority or Other|||||||0.839|||||||Wilcoxon rank-sum test|||C1D14 : C1D1|
1761565|NCT00137436|3234390|Superiority or Other|||||||0.49|||||||Wilcoxon rank-sum test|||C3.D14 : C1D1|
1761566|NCT00137436|3234390|Superiority or Other|||||||0.812|||||||Wilcoxon rank-sum test|||C2.D14 : C1D1|
1761567|NCT00137436|3234390|Superiority or Other|||||||0.904|||||||Wilcoxon rank-sum test|||C2.D1 : C1D1|
1761568|NCT00137436|3234390|Superiority or Other|||||||0.386|||||||Wilcoxon rank-sum test|||C1D14 : C1D1|
1761569|NCT00137436|3234391|Superiority or Other|||||||1|||||||Wilcoxon rank-sum test|||C3.D14 : C1D1|
1761570|NCT00137436|3234391|Superiority or Other|||||||0.185|||||||Wilcoxon rank-sum test|||C2.D14 : C1D1|
1761571|NCT00137436|3234391|Superiority or Other|||||||0.962|||||||Wilcoxon rank-sum test|||C2.D1 : C1D1|
1761572|NCT00137436|3234391|Superiority or Other|||||||0.736|||||||Wilcoxon rank-sum test|||C1D14 : C1D1|
1761573|NCT00137436|3234392|Superiority or Other|||||||0.873|||||||Wilcoxon rank-sum test|||C3.D14 : C1D1|
1761574|NCT00137436|3234392|Superiority or Other|||||||0.865|||||||Wilcoxon rank-sum test|||C2.D14 : C1D1|
1761575|NCT00137436|3234392|Superiority or Other|||||||0.323|||||||Wilcoxon rank-sum test|||C2.D1 : C1D1|
1761576|NCT00137436|3234392|Superiority or Other|||||||0.942|||||||Wilcoxon rank-sum test|||C1D14 : C1D1|
1761577|NCT00137423|3234400|Superiority or Other||1-year survival rate|66.0||||||95.0|51.6|77.1|||||valid presentation only if at least 1 patient has overall survival >=1 year. Based on normal approximation, 95% CI will be derived by log transformation of the cumulative hazard rate.||
1761578|NCT00137423|3234400|Superiority or Other||1-year survival rate|77.4||||||95.0|63.6|86.5|||||valid presentation only if at least 1 patient has overall survival >=1 year. Based on normal approximation, 95% CI will be derived by log transformation of the cumulative hazard rate.||
1761579|NCT00137423|3234404|Superiority or Other||Objective Response Rate|11.5||||||95.0|4.4|23.4||||||Objective response rate required a sample size of 100 to test null hypothesis that true response rate was <=5% versus alternative hypothesis that true response rate was >=15% with 90% power and alpha level of 0.05. If number of OR> =11 null hypothesis that true response rate was <=5% could be rejected with a target α error rate of 0.05.|
1761580|NCT00137423|3234404|Superiority or Other||Objective Response Rate|28.3||||||95.0|16.8|42.3||||||Objective response rate required a sample size of 100 to test null hypothesis that true response rate was <=5% versus alternative hypothesis that true response rate was >=15% with 90% power and alpha level of 0.05. If number of OR> =11 null hypothesis that true response rate was <=5% could be rejected with a target α error rate of 0.05.|
1761581|NCT00137280|3234405|Superiority or Other|||||||0.11|||||||Chi-squared||||
1761582|NCT00137280|3234406|Superiority or Other||Odds Ratio (OR)|2.3|||<|0.01|2-Sided|95.0|1.22|4.34|||Regression, Logistic||Comparison group is the control (denominator)||
1761583|NCT00137280|3234407|Superiority or Other||Mean Difference (Final Values)|13.02|Standard Error of the Mean|5.93||0.03|||||||ANCOVA||||
1761584|NCT00137280|3234408|Superiority or Other||Odds Ratio (OR)|2.3|||<|0.01|2-Sided|95.0|1.47|3.58|||Regression, Logistic||Comparison group is the control (denominator)||
1761585|NCT00137267|3234409|Superiority or Other|||||||0.152|||||||Chi-squared||||
1761586|NCT00137267|3234410|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1761587|NCT00137111|3234411|Superiority or Other (legacy)|||||||7e-07|||||||Wilcoxon (Mann-Whitney)||||
1761589|NCT00137111|3234413|Superiority or Other (legacy)|||||||0.15||||||p-value from t-test after adjusted for lineage and ploidy|t-test, 2 sided|||t-test adjusting for lineage and ploidy|
1761590|NCT00137111|3234414|Superiority or Other (legacy)|||||||0.0062||||||p-value from t-test after stratified for lineage and ploidy|t-test, 2 sided|||t-test stratified for lineage and ploidy|
1761591|NCT00137111|3234415|Superiority or Other (legacy)||Binomial proportion|79.27|||||2-Sided|95.0|75.69|82.85||||||Of the 498 eligible patients, 492 were successfully evaluated with day 46 MRD measurement.|
1761592|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.061|Standard Error of the Mean|0.323||||90.0|-0.594|0.472||||||Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761593|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.72|Standard Error of the Mean|0.28||||90.0|-1.183|-0.258||||||Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761594|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-1.378|Standard Error of the Mean|0.628||||90.0|-2.42|-0.335||||||Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761595|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.744|Standard Error of the Mean|0.346||||90.0|-1.315|-0.173||||||Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761596|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.522|Standard Error of the Mean|0.29||||90.0|-1.0|-0.043||||||Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761597|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.636|Standard Error of the Mean|0.293||||90.0|-1.119|-0.153||||||Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761598|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.39|Standard Error of the Mean|0.303||||90.0|-0.89|0.111||||||Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761599|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.853|Standard Error of the Mean|0.295||||90.0|-1.34|-0.367||||||Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761600|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.647|Standard Error of the Mean|0.276||||90.0|-1.104|-0.191||||||Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761601|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.525|Standard Error of the Mean|0.267||||90.0|-0.965|-0.084||||||Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761602|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.823|Standard Error of the Mean|0.286||||90.0|-1.296|-0.351||||||Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761603|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.93|Standard Error of the Mean|0.268||||90.0|-1.372|-0.487||||||Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761604|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.385|Standard Error of the Mean|0.265||||90.0|-0.822|0.053||||||Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761605|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.255||||90.0|-0.88|-0.04||||||Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761606|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.579|Standard Error of the Mean|0.247||||90.0|-0.986|-0.172||||||Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761607|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.46|Standard Error of the Mean|0.252||||90.0|-0.876|-0.043||||||Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761608|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|0.069|Standard Error of the Mean|0.208||||90.0|-0.274|0.411||||||Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761609|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|0.166|Standard Error of the Mean|0.198||||90.0|-0.16|0.492||||||Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761610|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.211||||90.0|-0.197|0.497||||||Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761611|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.385|Standard Error of the Mean|0.213||||90.0|-0.736|-0.034||||||Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761612|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.613|Standard Error of the Mean|0.212||||90.0|-0.962|-0.263||||||Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761613|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.577|Standard Error of the Mean|0.202||||90.0|-0.91|-0.245||||||Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761614|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.61|Standard Error of the Mean|0.19||||90.0|-0.923|-0.296||||||Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761615|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.826|Standard Error of the Mean|0.181||||90.0|-1.123|-0.528||||||Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761616|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.667|Standard Error of the Mean|0.171||||90.0|-0.949|-0.384||||||Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761617|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.797|Standard Error of the Mean|0.167||||90.0|-1.073|-0.522||||||Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761618|NCT00137046|3234424|Superiority or Other||Mean Difference (Final Values)|-0.744|Standard Error of the Mean|0.144||||90.0|-0.981|-0.506||||||Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761619|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.487|Standard Error of the Mean|0.866||||90.0|-2.918|-0.055||||||Extension Follow Up Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761620|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-3.131|Standard Error of the Mean|1.356||||90.0|-5.382|-0.88||||||Extension Month 39; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761621|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.486|Standard Error of the Mean|0.857||||90.0|-2.901|-0.071||||||Extension Month 36; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761622|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-3.287|Standard Error of the Mean|1.091||||90.0|-5.088|-1.485||||||Extension Month 33; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761623|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-2.794|Standard Error of the Mean|0.891||||90.0|-4.264|-1.324||||||Extension Month 30; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761624|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.887|Standard Error of the Mean|0.725||||90.0|-3.084|-0.69||||||Extension Month 27; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761625|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.872|Standard Error of the Mean|0.692||||90.0|-3.013|-0.73||||||Extension Month 24; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761626|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.667|Standard Error of the Mean|0.668||||90.0|-2.77|-0.565||||||Extension Month 21; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761627|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-0.96|Standard Error of the Mean|0.655||||90.0|-2.041|0.121||||||Extension Month 18; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761628|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|0.588||||90.0|-1.97|-0.03||||||Extension Month 15; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761629|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-0.955|Standard Error of the Mean|0.559||||90.0|-1.877|-0.034||||||Extension Month 12; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761630|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.385|Standard Error of the Mean|0.564||||90.0|-2.316|-0.454||||||Extension Month 9; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761631|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.462|Standard Error of the Mean|0.542||||90.0|-2.356|-0.568||||||Extension Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761632|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.336|Standard Error of the Mean|0.668||||90.0|-2.438|-0.235||||||Extension Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761633|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-0.054|Standard Error of the Mean|0.654||||90.0|-1.133|1.025||||||Extension Month 1; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761634|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-0.445|Standard Error of the Mean|0.406||||90.0|-1.114|0.224||||||Follow-up Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761635|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-0.785|Standard Error of the Mean|0.418||||90.0|-1.475|-0.096||||||Follow-up Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761636|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.069|Standard Error of the Mean|0.439||||90.0|-1.792|-0.346||||||Month 24; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761637|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.273|Standard Error of the Mean|0.411||||90.0|-1.95|-0.596||||||Month 21; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761638|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.717|Standard Error of the Mean|0.384||||90.0|-2.35|-1.084||||||Month 18; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761639|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.426|Standard Error of the Mean|0.338||||90.0|-1.984|-0.869||||||Month 15; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761640|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.184|Standard Error of the Mean|0.314||||90.0|-1.702|-0.666||||||Month 12; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761641|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.359|Standard Error of the Mean|0.29||||90.0|-1.836|-0.882||||||Month 9; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761642|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-1.113|Standard Error of the Mean|0.26||||90.0|-1.541|-0.685||||||Month 6; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761643|NCT00137046|3234433|Superiority or Other||Mean Difference (Final Values)|-0.523|Standard Error of the Mean|0.196||||90.0|-0.846|-0.199||||||Month 3; Treatment-Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Body Weight, and Center.|
1761644|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|2.84|Standard Error of the Mean|11.27||||90.0|-15.79|21.46||||||Extension Follow Up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761645|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-15.58|Standard Error of the Mean|13.77||||90.0|-38.43|7.26||||||Extension Month 39; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761646|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-5.39|Standard Error of the Mean|9.44||||90.0|-20.98|10.21||||||Extension Month 36; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761647|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-6.17|Standard Error of the Mean|9.24||||90.0|-21.42|9.09||||||Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761648|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-10.4|Standard Error of the Mean|8.67||||90.0|-24.71|3.92||||||Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761649|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-9.52|Standard Error of the Mean|8.8||||90.0|-24.04|5.0||||||Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761650|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-8.99|Standard Error of the Mean|8.91||||90.0|-23.69|5.71||||||Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761651|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-28.64|Standard Error of the Mean|8.82||||90.0|-43.19|-14.09||||||Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761652|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-10.22|Standard Error of the Mean|8.58||||90.0|-24.39|3.94||||||Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761653|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-12.99|Standard Error of the Mean|8.25||||90.0|-26.6|0.63||||||Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761654|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-16.34|Standard Error of the Mean|7.84||||90.0|-29.28|-3.4||||||Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761655|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-8.72|Standard Error of the Mean|9.02||||90.0|-23.61|6.17||||||Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761656|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|1.8|Standard Error of the Mean|7.8||||90.0|-11.06|14.66||||||Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761867|NCT00135798|3234518|Superiority or Other|||||||0.8065|||||||Chi-squared|||PP analysis of LADR-treated: 7/30 G1,4,6 vs 6/29 G2,3|
1761657|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-20.71|Standard Error of the Mean|7.72||||90.0|-33.44|-7.99||||||Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761658|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-17.8|Standard Error of the Mean|8.2||||90.0|-31.32|-4.27||||||Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761659|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|3.56|Standard Error of the Mean|8.12||||90.0|-9.83|16.96||||||Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin.Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761660|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-18.86|Standard Error of the Mean|7.29||||90.0|-30.88|-6.84||||||Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761661|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-13.54|Standard Error of the Mean|6.76||||90.0|-24.69|-2.39||||||Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761662|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-16.08|Standard Error of the Mean|7.02||||90.0|-27.65|-4.51||||||Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761663|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-39.97|Standard Error of the Mean|6.65||||90.0|-50.93|-29.0||||||Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761664|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-19.46|Standard Error of the Mean|6.74||||90.0|-30.56|-8.36||||||Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761665|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-26.16|Standard Error of the Mean|6.92||||90.0|-37.56|-14.75||||||Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761666|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-24.83|Standard Error of the Mean|6.27||||90.0|-35.16|-14.51||||||Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761667|NCT00137046|3234434|Superiority or Other||Mean Difference (Final Values)|-14.81|Standard Error of the Mean|6.33||||90.0|-25.24|-4.39||||||Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline Fasting Plasma Glucose, and Center.|
1761668|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.032|Standard Error of the Mean|0.124||||90.0|-0.174|0.237||||||Extension Follow Up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761669|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.451|Standard Error of the Mean|0.161||||90.0|0.183|0.718||||||Extension Month 39; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761670|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.41|Standard Error of the Mean|0.115||||90.0|0.221|0.6||||||Extension Month 36; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761671|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.462|Standard Error of the Mean|0.097||||90.0|0.302|0.622||||||Extension Month 33; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761672|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.331|Standard Error of the Mean|0.092||||90.0|0.18|0.483||||||Extension Month 30; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761673|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.211|Standard Error of the Mean|0.095||||90.0|0.055|0.368||||||Extension Month 27; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761674|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.225|Standard Error of the Mean|0.089||||90.0|0.079|0.372||||||Extension Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761675|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.227|Standard Error of the Mean|0.09||||90.0|0.079|0.376||||||Extension Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761676|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.243|Standard Error of the Mean|0.086||||90.0|0.101|0.386||||||Extension Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761677|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.213|Standard Error of the Mean|0.094||||90.0|0.058|0.369||||||Extension Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761678|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.293|Standard Error of the Mean|0.091||||90.0|0.144|0.442||||||Extension Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761679|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.278|Standard Error of the Mean|0.091||||90.0|0.128|0.428||||||Extension Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761680|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.363|Standard Error of the Mean|0.087||||90.0|0.219|0.507||||||Extension Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761681|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.273|Standard Error of the Mean|0.089||||90.0|0.126|0.419||||||Extension Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761682|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.112|Standard Error of the Mean|0.082||||90.0|-0.023|0.248||||||Extension Month 1; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761683|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.021|Standard Error of the Mean|0.075||||90.0|-0.103|0.145||||||Follow-up Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761684|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.093|Standard Error of the Mean|0.079||||90.0|-0.037|0.224||||||Follow-up Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761685|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.316|Standard Error of the Mean|0.077||||90.0|0.19|0.443||||||Month 24; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761686|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.078||||90.0|0.06|0.319||||||Month 21; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761687|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.182|Standard Error of the Mean|0.072||||90.0|0.065|0.3||||||Month 18; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761688|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.156|Standard Error of the Mean|0.071||||90.0|0.04|0.273||||||Month 15; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761689|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.257|Standard Error of the Mean|0.071||||90.0|0.141|0.374||||||Month 12; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761690|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.112|Standard Error of the Mean|0.068||||90.0|0.0|0.224||||||Month 9; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761691|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.136|Standard Error of the Mean|0.062||||90.0|0.033|0.239||||||Month 6; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761692|NCT00137046|3234437|Superiority or Other||Mean Difference (Final Values)|0.031|Standard Error of the Mean|0.055||||90.0|-0.06|0.122||||||Month 3; Treatment Difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted model includes terms of Treatment, Baseline HbA1c, and Center.|
1761693|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.044|Standard Error of the Mean|0.024||||90.0|-0.085|-0.004||||||Extension Follow Up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761694|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.066|Standard Error of the Mean|0.02||||90.0|-0.098|-0.033||||||Extension Month 39 (LOCF); Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761695|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.061|Standard Error of the Mean|0.038||||90.0|-0.124|0.003||||||Extension Month 39; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761696|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.079|Standard Error of the Mean|0.025||||90.0|-0.121|-0.038||||||Extension Month 36; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761697|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.036|Standard Error of the Mean|0.023||||90.0|-0.073|0.002||||||Extension Month 33; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761698|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.045|Standard Error of the Mean|0.022||||90.0|-0.081|-0.01||||||Extension Month 30; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761699|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.055|Standard Error of the Mean|0.022||||90.0|-0.091|-0.019||||||Extension Month 27; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761700|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.042|Standard Error of the Mean|0.022||||90.0|-0.079|-0.004||||||Extension Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761701|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.022||||90.0|-0.055|0.016||||||Extension Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761702|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.044|Standard Error of the Mean|0.021||||90.0|-0.079|-0.01||||||Extension Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761703|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.039|Standard Error of the Mean|0.019||||90.0|-0.071|-0.007||||||Extension Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761704|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.056|Standard Error of the Mean|0.019||||90.0|-0.088|-0.025||||||Extension Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761705|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.041|Standard Error of the Mean|0.02||||90.0|-0.074|-0.008||||||Extension Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761706|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.04|Standard Error of the Mean|0.019||||90.0|-0.071|-0.008||||||Extension Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761707|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.045|Standard Error of the Mean|0.019||||90.0|-0.076|-0.013||||||Extension Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761708|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.045|Standard Error of the Mean|0.019||||90.0|-0.076|-0.014||||||Extension Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761709|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.013|Standard Error of the Mean|0.015||||90.0|-0.037|0.012||||||Follow-up Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761710|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.005|Standard Error of the Mean|0.014||||90.0|-0.027|0.017||||||Follow-up Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761711|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.015|Standard Error of the Mean|0.015||||90.0|-0.039|0.009||||||Follow-up Month 1; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761712|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.033|Standard Error of the Mean|0.015||||90.0|-0.058|-0.009||||||Month 24; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761713|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.043|Standard Error of the Mean|0.014||||90.0|-0.066|-0.02||||||Month 21; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761714|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.014||||90.0|-0.043|0.002||||||Month 18; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761715|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.042|Standard Error of the Mean|0.014||||90.0|-0.065|-0.02||||||Month 15; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761716|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.038|Standard Error of the Mean|0.012||||90.0|-0.058|-0.019||||||Month 12; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761717|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.012||||90.0|-0.038|0.001||||||Month 9; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761718|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.022|Standard Error of the Mean|0.011||||90.0|-0.04|-0.003||||||Month 6; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761719|NCT00137046|3234439|Superiority or Other||Mean Difference (Final Values)|-0.024|Standard Error of the Mean|0.01||||90.0|-0.041|-0.007||||||Month 3; Treatment difference: Inhaled Insulin - Subcutaneous Insulin. Adjusted (Primary Analysis Model) includes terms of Treatment, Baseline Pulmonary Function Test (PFT), Center, Age, Sex, and Height.|
1761720|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.619|Standard Error of the Mean|0.292||||90.0|0.137|1.102|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext FU M3|
1761721|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.399|Standard Error of the Mean|0.244||||90.0|-0.003|0.802|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.|Ext M36 LOCF|
1761722|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.267|Standard Error of the Mean|0.383||||90.0|-0.37|0.904|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M36|
1761723|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.262|Standard Error of the Mean|0.273||||90.0|-0.189|0.714|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M33|
1761724|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|-0.117|Standard Error of the Mean|0.28||||90.0|-0.579|0.346|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M30|
1761725|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.19|Standard Error of the Mean|0.284||||90.0|-0.279|0.659|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M27|
1761868|NCT00135798|3234518|Superiority or Other|||||||0.0153||||||One-sided test|Fisher Exact|||PP analysis of CVR: 0/20 Standard care vs. 13/59 Combined LADR-treated groups|
1761726|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.043|Standard Error of the Mean|0.28||||90.0|-0.419|0.506|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M24|
1761727|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.321|Standard Error of the Mean|0.278||||90.0|-0.138|0.78|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M21|
1761728|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.146|Standard Error of the Mean|0.247||||90.0|-0.262|0.554|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M18|
1761729|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.023|Standard Error of the Mean|0.253||||90.0|-0.395|0.441|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M15|
1761730|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.126|Standard Error of the Mean|0.248||||90.0|-0.284|0.535|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M12|
1761731|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.245|Standard Error of the Mean|0.257||||90.0|-0.18|0.669|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M9|
1761732|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|-0.202|Standard Error of the Mean|0.226||||90.0|-0.576|0.172|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M6|
1761733|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.098|Standard Error of the Mean|0.235||||90.0|-0.289|0.485|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M3|
1761734|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.136|Standard Error of the Mean|0.22||||90.0|-0.227|0.5|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M1|
1761735|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.318|Standard Error of the Mean|0.186||||90.0|0.011|0.626|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M6|
1761736|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.354|Standard Error of the Mean|0.184||||90.0|0.051|0.657|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M3|
1761737|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.617|Standard Error of the Mean|0.179||||90.0|0.322|0.911|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M1|
1761738|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.119|Standard Error of the Mean|0.189||||90.0|-0.193|0.431|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M24|
1761739|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|-0.155|Standard Error of the Mean|0.176||||90.0|-0.445|0.134|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M21|
1761740|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|-0.141|Standard Error of the Mean|0.173||||90.0|-0.427|0.145|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M18|
1761741|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|-0.181|Standard Error of the Mean|0.165||||90.0|-0.453|0.091|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M15|
1761742|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|-0.266|Standard Error of the Mean|0.156||||90.0|-0.524|-0.009|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M12|
1761743|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|0.084|Standard Error of the Mean|0.146||||90.0|-0.158|0.325|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M9|
1761744|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|-0.095|Standard Error of the Mean|0.139||||90.0|-0.323|0.134|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M6|
1761745|NCT00136916|3234453|Superiority or Other||Mean Difference (Final Values)|-0.251|Standard Error of the Mean|0.13||||90.0|-0.466|-0.037|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M3|
1761746|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-1.637|Standard Error of the Mean|0.898||||90.0|-3.12|-0.153|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext FU M3|
1761747|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-2.766|Standard Error of the Mean|1.305||||90.0|-4.932|-0.599|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M36|
1761748|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-2.281|Standard Error of the Mean|0.908||||90.0|-3.781|-0.782|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M33|
1761749|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-1.401|Standard Error of the Mean|0.82||||90.0|-2.755|-0.047|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M30|
1761750|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-2.72|Standard Error of the Mean|1.041||||90.0|-4.439|-1.001|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M27|
1761751|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-1.566|Standard Error of the Mean|0.788||||90.0|-2.867|-0.265|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M24|
1761752|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-2.399|Standard Error of the Mean|0.904||||90.0|-3.891|-0.907|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M21|
1761753|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-1.313|Standard Error of the Mean|0.916||||90.0|-2.824|0.198|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M18|
1761754|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-1.512|Standard Error of the Mean|0.696||||90.0|-2.661|-0.363|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M15|
1761755|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-1.316|Standard Error of the Mean|0.676||||90.0|-2.431|-0.2|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M12|
1761756|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-1.001|Standard Error of the Mean|0.654||||90.0|-2.08|0.078|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M9|
1761757|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-0.834|Standard Error of the Mean|0.652||||90.0|-1.909|0.241|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M6|
1761758|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-1.28|Standard Error of the Mean|0.573||||90.0|-2.225|-0.334|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M3|
1761759|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-0.904|Standard Error of the Mean|0.603||||90.0|-1.898|0.09|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|Ext M1|
1761760|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-1.557|Standard Error of the Mean|0.596||||90.0|-2.539|-0.575|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|FU M6|
1761761|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-1.303|Standard Error of the Mean|0.475||||90.0|-2.086|-0.52|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|FU M3|
1761762|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-1.355|Standard Error of the Mean|0.464||||90.0|-2.12|-0.589|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M24|
1761763|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-0.642|Standard Error of the Mean|0.37||||90.0|-1.251|-0.032|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M12|
1761764|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-0.735|Standard Error of the Mean|0.297||||90.0|-1.224|-0.246|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M6|
1761765|NCT00136916|3234459|Superiority or Other||Mean Difference (Final Values)|-0.059|Standard Error of the Mean|0.217||||90.0|-0.416|0.299|||||Adjusted Primary Analysis Model includes terms of treatment, baseline weight, and center.|M3|
1761766|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-4.673|Standard Error of the Mean|8.77||||90.0|-19.16|9.812|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext FU M3|
1761767|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-21.88|Standard Error of the Mean|8.906||||90.0|-36.66|-7.105|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M36|
1761768|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-8.49|Standard Error of the Mean|7.625||||90.0|-21.09|4.107|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M33|
1761769|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-3.22|Standard Error of the Mean|7.223||||90.0|-15.15|8.705|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M30|
1761770|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-19.07|Standard Error of the Mean|6.895||||90.0|-30.45|-7.685|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M27|
1761771|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-12.53|Standard Error of the Mean|7.329||||90.0|-24.63|-0.429|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M24|
1761772|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-7.078|Standard Error of the Mean|7.217||||90.0|-18.99|4.834|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M21|
1761773|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-9.022|Standard Error of the Mean|7.156||||90.0|-20.83|2.79|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M18|
1761774|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-1.848|Standard Error of the Mean|7.219||||90.0|-13.76|10.066|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M15|
1761775|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-7.287|Standard Error of the Mean|7.192||||90.0|-19.15|4.579|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M12|
1761776|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-6.827|Standard Error of the Mean|6.154||||90.0|-16.98|3.328|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M9|
1761777|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-10.76|Standard Error of the Mean|6.785||||90.0|-21.95|0.438|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M6|
1761778|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-9.481|Standard Error of the Mean|6.446||||90.0|-20.11|1.153|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M3|
1761779|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-9.46|Standard Error of the Mean|6.007||||90.0|-19.37|0.45|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|Ext M1|
1761780|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|2.578|Standard Error of the Mean|7.173||||90.0|-9.257|14.412|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|FU M6|
1761781|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-16.83|Standard Error of the Mean|21.867||||90.0|-80.69|47.019|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|FU M3|
1761782|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-12.56|Standard Error of the Mean|5.052||||90.0|-20.89|-4.232|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M24|
1761869|NCT00135798|3234519|Superiority or Other|||||||0.6011|||||||Chi-squared|||PP analysis of LADR-treated: 5/23 G1,4,6 vs 6/21 G2,3|
1761783|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-10.96|Standard Error of the Mean|4.92||||90.0|-19.07|-2.852|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M12|
1761784|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-14.21|Standard Error of the Mean|4.795||||90.0|-22.11|-6.312|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M6|
1761785|NCT00136916|3234460|Superiority or Other||Mean Difference (Final Values)|-12.39|Standard Error of the Mean|4.054||||90.0|-19.07|-5.71|||||Adjusted Primary Analysis Model includes terms of treatment, baseline fasting plasma glucose, and center.|M3|
1761786|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.163||||90.0|-0.245|0.292|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext FU M3|
1761787|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.011|Standard Error of the Mean|0.197||||90.0|-0.316|0.337|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M36|
1761788|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|9.824|Standard Error of the Mean|8.319||||90.0|-3.92|23.569|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M33|
1761789|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.046|Standard Error of the Mean|0.132||||90.0|-0.171|0.264|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M30|
1761790|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.067|Standard Error of the Mean|0.124||||90.0|-0.138|0.272|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M27|
1761791|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.047|Standard Error of the Mean|0.123||||90.0|-0.156|0.249|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M24|
1761792|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.064|Standard Error of the Mean|0.124||||90.0|-0.141|0.27|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M21|
1761793|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.087|Standard Error of the Mean|0.12||||90.0|-0.111|0.284|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M18|
1761794|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.074|Standard Error of the Mean|0.125||||90.0|-0.132|0.279|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M15|
1761795|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.104|Standard Error of the Mean|0.118||||90.0|-0.09|0.298|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M12|
1761796|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.15|Standard Error of the Mean|0.116||||90.0|-0.041|0.342|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M9|
1761797|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.141|Standard Error of the Mean|0.108||||90.0|-0.038|0.32|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M6|
1761798|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.081|Standard Error of the Mean|0.11||||90.0|-0.101|0.263|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M3|
1761799|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|-0.019|Standard Error of the Mean|0.11||||90.0|-0.2|0.161|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|Ext M1|
1761800|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.036|Standard Error of the Mean|0.094||||90.0|-0.119|0.19|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|FU M6|
1761801|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.006|Standard Error of the Mean|0.09||||90.0|-0.143|0.154|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|FU M3|
1761802|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.1|Standard Error of the Mean|0.096||||90.0|-0.058|0.257|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M24|
1761803|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.068|Standard Error of the Mean|0.085||||90.0|-0.073|0.208|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M21|
1761804|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.09|Standard Error of the Mean|0.087||||90.0|-0.054|0.234|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M18|
1761805|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.052|Standard Error of the Mean|0.081||||90.0|-0.081|0.185|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M15|
1761806|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.091|Standard Error of the Mean|0.075||||90.0|-0.033|0.214|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M12|
1761807|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|0.01|Standard Error of the Mean|0.069||||90.0|-0.104|0.124|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M9|
1761808|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|-0.023|Standard Error of the Mean|0.067||||90.0|-0.133|0.087|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M6|
1761809|NCT00136916|3234461|Superiority or Other||Mean Difference (Final Values)|-0.119|Standard Error of the Mean|0.058||||90.0|-0.215|-0.023|||||Adjusted Primary Analysis Model includes terms of treatment, baseline HbA1c, and center.|M3|
1761810|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|0.019|Standard Error of the Mean|0.026||||90.0|-0.023|0.062|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext FU M3|
1761811|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.023||||90.0|-0.042|0.035|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height. Ext M36 (LOCF) based on data in the extension phase only.|Ext M36 LOCF|
1761812|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|0.024|Standard Error of the Mean|0.032||||90.0|-0.03|0.077|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M36|
1761813|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|0.008|Standard Error of the Mean|0.03||||90.0|-0.042|0.058|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M33|
1761814|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.005|Standard Error of the Mean|0.027||||90.0|-0.051|0.04|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M30|
1761815|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Error of the Mean|0.026||||90.0|-0.044|0.043|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M27|
1761816|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.015|Standard Error of the Mean|0.028||||90.0|-0.061|0.03|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M24|
1761817|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.015|Standard Error of the Mean|0.026||||90.0|-0.058|0.029|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M21|
1761818|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.011|Standard Error of the Mean|0.027||||90.0|-0.055|0.033|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M18|
1761819|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|0.007|Standard Error of the Mean|0.025||||90.0|-0.034|0.048|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M15|
1761820|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.018|Standard Error of the Mean|0.024||||90.0|-0.058|0.022|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M12|
1761821|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.036|Standard Error of the Mean|0.024||||90.0|-0.075|0.003|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|Ext M9|
1761822|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.039|Standard Error of the Mean|0.023||||90.0|-0.077|-0.002|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M6|
1761823|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.033|Standard Error of the Mean|0.023||||90.0|-0.07|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M3|
1761824|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.004|Standard Error of the Mean|0.022||||90.0|-0.04|0.032|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|Ext M1|
1761825|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|0.027|Standard Error of the Mean|0.017||||90.0|-0.002|0.055|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M6|
1761826|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|0.014|Standard Error of the Mean|0.018||||90.0|-0.016|0.044|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M3|
1761827|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|0.007|Standard Error of the Mean|0.017||||90.0|-0.021|0.034|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|FU M1|
1761828|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.026|Standard Error of the Mean|0.017||||90.0|-0.054|0.002|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M24|
1761829|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.017||||90.0|-0.047|0.007|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M21|
1761830|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.023|Standard Error of the Mean|0.016||||90.0|-0.05|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M18|
1761831|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.023|Standard Error of the Mean|0.015||||90.0|-0.048|0.003|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M15|
1761832|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.014||||90.0|-0.044|0.004|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M12|
1761833|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.01|Standard Error of the Mean|0.014||||90.0|-0.033|0.013|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M9|
1761834|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.003|Standard Error of the Mean|0.014||||90.0|-0.025|0.02|||||Adjusted Primary Analysis Model includes terms of treatment, baseline PFTs, center, age, sex, and height.|M6|
1761835|NCT00136916|3234467|Superiority or Other||Mean Difference (Final Values)|-0.045|Standard Error of the Mean|0.011||||90.0|-0.064|-0.026|||||Adjusted Primary Analysis Model includes terms of treatment, baseline pulmonary function tests (PFTs), center, age, sex, and height.|M3|
1761836|NCT00136812|3234471|Superiority or Other||Odds Ratio (OR)|3.15|||<|0.05|2-Sided|95.0|||||Odds ratio||||
1761837|NCT00136604|3234497|Non-Inferiority|Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% CI on the difference in seroprotection (anti-PRP concentration ≥ 1.0 µg/mL) between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the Tritanrix-Hepb/Mencevax+Tritanrix-HepB/Hiberix Group was above -10%.|Difference in seroprotection rate|0.0|||||2-Sided|95.0|-1.53|3.05||||||Demonstration of non-inferiority of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus the Tritanrix-HepB/Hiberix vaccine when used as a booster vaccine in Tritanrix-HepB/Hib-MenAC-TT primed subjects in terms of the percentage of subjects with an anti-PRP concentration ≥ 1.0 µg/mL.|
1761870|NCT00135798|3234519|Superiority or Other|||||||0.0274||||||One-sided test|Fisher Exact|||PP analysis of pTVR: 0/13 Standard care vs. 11/44 Combined LADR-treated groups|
1761871|NCT00135798|3234520|Superiority or Other|||||||0.9513|||||||Chi-squared|||ITT analysis of LADR-treated: 6/31 Genotypes 1,4,6 vs 6/32 Genotypes 2,3|
1761838|NCT00136604|3234499|Non-Inferiority|Criterion for non-inferiority evaluation: The lower limit (LL) of the standardized asymptotic 95% confidence interval (CI) on the difference in the percentage of subjects with SBA-MenC titre ≥ 1:128 between the Tritanrix-Hepb/Hib-MenAC-TT Group and (minus) the TRITANRIX-HEPB+Mencevax + Meningitec control group was above –10%.|Difference in percentage of subjects|0.0|||||2-Sided|95.0|-1.53|3.05||||||Demonstration of non-inferiority of a fourth dose of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus a fourth dose of the Tritanrix-HepB/Hiberix and Meningitec vaccine given concomitantly in terms of the percentage of subjects with an SBA-MenC titre ≥ 1:128.|
1761839|NCT00136214|3234509|Superiority||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 2 on change between scores for ROCF|
1761840|NCT00136214|3234509|Superiority||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 2 on change between scores for HVLT|
1761841|NCT00136214|3234509|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 1 on change between scores for ROCF|
1761842|NCT00136214|3234509|Superiority||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Comparison between controls and IFN treated at time point 1 on change between scores for HVLT|
1761843|NCT00136214|3234510|Superiority|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of NAA/Crat time points 1 and 2|
1761844|NCT00136214|3234510|Superiority|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2|
1761845|NCT00136214|3234510|Superiority|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in DLPFC. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2|
1761846|NCT00136214|3234510|Superiority|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of NAA/Cr at time points 1 and 2|
1761847|NCT00136214|3234510|Superiority|||||||0.1|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2|
1761848|NCT00136214|3234510|Superiority|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in frontal cortex. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2|
1761849|NCT00136214|3234510|Superiority|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of NAA/Cr at time points 1 and 2|
1761850|NCT00136214|3234510|Superiority|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of MI/Cr at time points 1 and 2|
1761851|NCT00136214|3234510|Superiority|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of control group for metabolites in Basal ganglia. Comparison on MR spectroscopy of Cho/Cr at time points 1 and 2|
1761852|NCT00136214|3234510|Superiority|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3|
1761853|NCT00136214|3234510|Superiority|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy ofMI/Cr at time points 1,2 and 3|
1761854|NCT00136214|3234510|Superiority|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in DLPFC. Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3|
1761855|NCT00136214|3234510|Superiority|||||||0.6|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3|
1761856|NCT00136214|3234510|Superiority|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of MI/Cr at time points 1,2 and 3|
1761857|NCT00136214|3234510|Superiority|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in frontal cortex. Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3|
1761858|NCT00136214|3234510|Superiority|||||||0.9|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of NAA/Cr at time points 1,2 and 3|
1761859|NCT00136214|3234510|Superiority|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of Mi/Cr at time points 1,2 and 3|
1761860|NCT00136214|3234510|Superiority|||||||0.08|||||||Wilcoxon (Mann-Whitney)|||Within group comparison of IFN group for metabolites in basal ganglia Comparison on MR spectroscopy of Cho/Cr at time points 1,2 and 3|
1761861|NCT00136084|3234511|Superiority or Other||Odds Ratio, log|-0.0139||||0.2287|2-Sided|95.0|-0.0365|0.00873|||Regression, Logistic||||
1761862|NCT00136084|3234512|Superiority or Other|||||||0.6|||||||t-test, 2 sided||||
1761863|NCT00136084|3234514|Superiority or Other||Binomial proportion|0.9||||||95.0|0.735|0.979|||||||
1761864|NCT00136084|3234515|Superiority or Other||Binomial proportion|0.931||||||95.0|0.772|0.992|||||||
1761865|NCT00136084|3234516|Superiority or Other||Binomial proportion|0.733||||||95.0|0.449|0.922||||||Estimate of the proportion of negative minimal residual disease.|
1761866|NCT00136084|3234517|Superiority or Other||Odds Ratio (OR)|1.624||||0.1559||95.0|0.832|3.205||The p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance is 0.041 so that the overall level of the study is maintained at 0.05 across the 4 interim analyses and the final analysis.|Cochran-Mantel-Haenszel|The p-value was computed using a Monte Carlo approximation (10000 permutations) to an exact, risk-group stratified, test.|The odds ratio is defined as the ratio of the odds that a LDAC patient is MRD positive to the odds that a HDAC patient is MRD positive.|The study was designed to test the null hypothesis that HDAC and LDAC result in the same proportion of patients with positive MRD after 22 days. Power calculations indicate that enrollment of a total of 186 MRD-evaluable patients in a 5-stage O’Brien-Fleming group sequential design gives 80% power at the 5% level to detect a change in the MRD-positive proportion from 0.50 to 0.30. The design was developed using East statistical software.|
1761872|NCT00135798|3234520|Superiority or Other|||||||0.2014||||||One-sided test|Fisher Exact|||ITT analysis of CVR: 1/16 Standard care vs. 12/63 Combined LADR-treated groups|
1761873|NCT00135798|3234521|Superiority or Other|||||||0.609|||||||Chi-squared|||ITT analysis of LADR-treated: 5/24 Genotypes 1,4,6 vs 6/22 Genotypes 2,3|
1761874|NCT00135798|3234521|Superiority or Other|||||||0.0477||||||One-sided test|Fisher Exact|||ITT analysis of pTVR: 0/13 Standard care vs. 11/46 Combined LADR-treated groups|
1761875|NCT00135707|3234522|Superiority or Other||Risk Ratio (RR)|1.12||||0.32|2-Sided|95.0|0.89|1.42|||Chi-squared||||
1761876|NCT00135707|3234523|Superiority or Other||Risk Ratio (RR)|1.02||||0.86|2-Sided|95.0|0.82|1.26|||Chi-squared||||
1761877|NCT00135707|3234524|Superiority or Other|||||||0.79|||||||Wilcoxon (Mann-Whitney)||||
1761878|NCT00135707|3234525|Superiority or Other||Risk Ratio (RR)|0.85||||0.56|2-Sided|95.0|0.49|1.48|||Chi-squared||||
1761879|NCT00135707|3234526|Superiority or Other||Risk Ratio (RR)|1.18||||0.62|2-Sided|95.0|0.61|2.3|||Chi-squared||||
1761880|NCT00135707|3234527|Superiority or Other||Risk Ratio (RR)|0.71||||0.41|2-Sided|95.0|0.32|1.6|||Chi-squared||||
1761881|NCT00135707|3234528|Superiority or Other||Risk Ratio (RR)|1.3||||0.34|2-Sided|95.0|0.76|2.23|||Chi-squared||||
1761882|NCT00135707|3234529|Superiority or Other||Risk Ratio (RR)|0.85||||0.78|2-Sided|95.0|0.29|2.54|||Chi-squared||||
1761883|NCT00135707|3234530|Superiority or Other||Risk Ratio (RR)|1.04||||0.75|2-Sided|95.0|0.83|1.3|||Chi-squared||||
1761884|NCT00135707|3234531|Superiority or Other||Risk Ratio (RR)|1.03||||0.58|2-Sided|95.0|0.92|1.15|||Chi-squared||||
1761885|NCT00135707|3234532|Superiority or Other||Risk Ratio (RR)|0.93||||0.32|2-Sided|95.0|0.81|1.07|||Chi-squared||||
1761886|NCT00135707|3234533|Superiority or Other||Risk Ratio (RR)|1.0||||0.98|2-Sided|95.0|0.79|1.27|||Chi-squared||||
1761887|NCT00135707|3234534|Superiority or Other|||||||0.55|||||||Wilcoxon (Mann-Whitney)||||
1761888|NCT00135707|3234535|Superiority or Other||Risk Ratio (RR)|0.92||||0.53|2-Sided|95.0|0.72|1.19|||Chi-squared||||
1761889|NCT00135707|3234536|Superiority or Other||Risk Ratio (RR)|0.86||||0.16|2-Sided|95.0|0.69|1.06|||Chi-squared|||<32 weeks' gestation|
1761890|NCT00135707|3234536|Superiority or Other||Risk Ratio (RR)|0.97||||0.63|2-Sided|95.0|0.87|1.09|||Chi-squared|||<37 weeks' gestation|
1761891|NCT00135707|3234537|Superiority or Other|||||||0.21|||||||Wilcoxon (Mann-Whitney)||||
1761892|NCT00135707|3234538|Superiority or Other|||||||0.65|||||||Wilcoxon (Mann-Whitney)||||
1761893|NCT00135707|3234539|Superiority or Other||Risk Ratio (RR)|0.67||||0.05|2-Sided|95.0|0.45|1.01|||Chi-squared||||
1761894|NCT00135707|3234540|Superiority or Other||Risk Ratio (RR)|0.3||||0.05|2-Sided|95.0|0.08|1.08|||Chi-squared||||
1761895|NCT00135707|3234542|Superiority or Other||Risk Ratio (RR)|1.03||||0.35|2-Sided|95.0|0.97|1.11|||Chi-squared||||
1761896|NCT00135707|3234543|Superiority or Other||Risk Ratio (RR)|0.66||||0.12|2-Sided|95.0|0.4|1.11|||Chi-squared||||
1761897|NCT00135707|3234544|Superiority or Other||Risk Ratio (RR)|0.96||||0.74|2-Sided|95.0|0.75|1.22|||Chi-squared||||
1761898|NCT00135707|3234545|Superiority or Other||Risk Ratio (RR)|1.21||||0.33|2-Sided|95.0|0.82|1.79|||Chi-squared||||
1761899|NCT00135707|3234546|Superiority or Other||Risk Ratio (RR)|0.75||||0.51|2-Sided|95.0|0.32|1.77|||Chi-squared||||
1761900|NCT00135707|3234547|Superiority or Other||Risk Ratio (RR)|0.73||||0.15||95.0|0.47|1.12|||Chi-squared||||
1761901|NCT00135707|3234548|Superiority or Other||Risk Ratio (RR)|1.07||||0.25|2-Sided|95.0|0.95|1.21|||Chi-squared||||
1761902|NCT00135707|3234549|Superiority or Other||Risk Ratio (RR)|1.1||||0.004|2-Sided|95.0|1.03|1.17|||Chi-squared||||
1761903|NCT00135707|3234550|Superiority or Other||Risk Ratio (RR)|1.07||||0.33|2-Sided|95.0|0.93|1.24|||Chi-squared||||
1761904|NCT00135707|3234551|Superiority or Other||Risk Ratio (RR)|1.09||||0.84|2-Sided|95.0|0.48|2.46|||Chi-squared||||
1761905|NCT00135707|3234552|Superiority or Other||Risk Ratio (RR)|1.3||||0.18|2-Sided|95.0|0.89|1.9|||Chi-squared||||
1761906|NCT00135707|3234553|Superiority or Other||Risk Ratio (RR)|0.81||||0.57|2-Sided|95.0|0.39|1.68|||Chi-squared||||
1761907|NCT00135707|3234554|Superiority or Other||Risk Ratio (RR)|2.49||||0.11|2-Sided|95.0|0.78|7.94|||Chi-squared||||
1761908|NCT00135707|3234555|Superiority or Other||Risk Ratio (RR)|0.63||||0.34|2-Sided|95.0|0.25|1.63|||Chi-squared||||
1761909|NCT00135707|3234556|Superiority or Other||Risk Ratio (RR)|0.68||||0.16|2-Sided|95.0|0.39|1.17|||Chi-squared||||
1761910|NCT00135707|3234557|Superiority or Other||Risk Ratio (RR)|0.79||||0.35|2-Sided|95.0|0.47|1.31|||Chi-squared||||
1761911|NCT00135707|3234558|Superiority or Other||Risk Ratio (RR)|1.03||||0.79|2-Sided|95.0|0.85|1.24|||Chi-squared||||
1761912|NCT00135707|3234559|Superiority or Other||Risk Ratio (RR)|1.07||||0.42|2-Sided|95.0|0.91|1.25|||Chi-squared|||The primary hypothesis states that antioxidant therapy initiated prior to 16 weeks gestation in women will reduce the frequency of serious maternal and infant complications associated with pregnancy related hypertension. We estimated that with a sample size of 10,000 women, the study would have 90% power to show a 30% reduction in the rate of the primary outcome, from 4% in the placebo to 2.8% in the vitamin group, with a two-sided type I error rate of 5%.|
1761913|NCT00135694|3234560|Superiority or Other||||||<|0.0001|||||||ANCOVA|Adjusted for immunosuppression dose the subject was receiving at the time of randomization.|||
1761914|NCT00135694|3234561|Superiority or Other|||||||0.0183|||||||ANCOVA|Adjusted for immunosuppression dose the subject was receiving at the time of randomization.|||
1761915|NCT00135694|3234567|Superiority or Other||Risk Difference (RD)|-13.0|||||2-Sided|90.0|-35.0|10.0|||||||
1761916|NCT00135356|3234576|Superiority or Other||Hazard Ratio (HR)|1.06|||||2-Sided|95.0|0.3|3.72|||||||
1761917|NCT00135356|3234588|Superiority or Other||Difference in Means|5.9||||0.1||95.0|-1.0|13.2||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 Total Body Fat|
1761973|NCT00135226|3234630|Other||Rate ratio|0.98|||||2-Sided|95.0|0.74|1.29|||||||
1761918|NCT00135356|3234588|Superiority or Other||Difference in Means|5.0||||0.0385||95.0|0.3|9.7||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 Total Body Fat|
1761919|NCT00135356|3234588|Superiority or Other||DIfference in Means|4.3||||0.16||95.0|-1.7|10.7||P-value not adjusted for multiple testing, 2-sided 95% CI.|Wilcoxon (Mann-Whitney)|||Week 96 TAT|
1761920|NCT00135356|3234588|Superiority or Other||DIfference in Means|3.6||||0.19||95.0|-1.8|9.4||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 TAT|
1761921|NCT00135356|3234589|Superiority or Other||Difference in Means|5.7||||0.17||95.0|-2.3|14.4||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||Week 96, Limb Fat|
1761922|NCT00135356|3234589|Superiority or Other||Difference in Means|4.6||||0.15||95.0|-1.7|11.4||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48, Limb Fat|
1761923|NCT00135356|3234589|Superiority or Other||Difference in Mean|6.8||||0.06||95.0|-0.2|14.2||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 SAT|
1761924|NCT00135356|3234589|Superiority or Other||Difference in Means|4.0||||0.16||95.0|-1.6|10.0||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||SAT, Week 48, LOCF|
1761925|NCT00135356|3234590|Superiority or Other||Difference in Means|5.3||||0.14||95.0|-1.7|12.9||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 96 Trunk Fat LOCF|
1761926|NCT00135356|3234590|Superiority or Other||Difference in Means|4.4||||0.14||95.0|-1.4|10.6||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 Trunk Fat LOCF|
1761927|NCT00135356|3234590|Superiority or Other||Difference in Mean|1.8||||0.68||95.0|-6.7|11.2||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||VAT, Week 96 LOCF|
1761928|NCT00135356|3234590|Superiority or Other||Difference in Mean|5.2||||0.27||95.0|-3.9|15.1||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||Week 48 VAT LOCF|
1761929|NCT00135356|3234591|Superiority or Other||Difference in Means|-0.01||||0.91||95.0|-0.14|0.13||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||OC|
1761930|NCT00135356|3234591|Superiority or Other||Difference in Means|0.02||||0.73||95.0|-0.1|0.14||P-value not adjusted for multiple testing, 2-sided 95% CI.|t-test, 2 sided|||LOCF|
1761931|NCT00135356|3234592|Superiority or Other||Difference in Means|0.07||||0.57||95.0|-0.07|12.0||P-value not adjusted for multiple testing. 2-sided 95% CI|t-test, 2 sided|||OC|
1761932|NCT00135356|3234592|Superiority or Other||Difference in Means|0.03||||0.48||95.0|-0.06|0.12||P-value not adjusted for multiple testing, 2-sided 95% CI|t-test, 2 sided|||LOCF|
1761933|NCT00135330|3234593|Superiority or Other|||||||0.168|||||||Generalized Linear Model||||
1761934|NCT00135330|3234594|Superiority or Other|||||||0.436|||||||ANOVA||||
1761935|NCT00135330|3234595|Superiority or Other|||||||0.575|||||||Fisher Exact||||
1761936|NCT00135330|3234596|Superiority or Other|||||||0.71|||||||MMRM||||
1761937|NCT00135330|3234597|Superiority or Other|||||||0.251|||||||MMRM||||
1761938|NCT00135330|3234598|Superiority or Other|||||||0.117|||||||MMRM||||
1761939|NCT00135330|3234599|Superiority or Other|||||||0.724|||||||ANCOVA||||
1761940|NCT00135330|3234600|Superiority or Other|||||||0.631|||||||ANCOVA||||
1761941|NCT00135330|3234601|Superiority or Other|||||||0.581|||||||ANCOVA||||
1761942|NCT00135330|3234602|Superiority or Other|||||||0.875|||||||MMRM||||
1761943|NCT00135330|3234603|Superiority or Other|||||||0.096|||||||MMRM||||
1761944|NCT00135330|3234604|Superiority or Other|||||||0.84|||||||MMRM||||
1761945|NCT00135330|3234605|Superiority or Other|||||||0.276|||||||MMRM||||
1761946|NCT00135330|3234606|Superiority or Other||||||<|0.001|||||||MMRM||||
1761947|NCT00135330|3234607|Superiority or Other|||||||0.341|||||||MMRM||||
1761948|NCT00135330|3234608|Superiority or Other|||||||0.106|||||||MMRM||||
1761949|NCT00135330|3234610|Superiority or Other|||||||0.555|||||||MMRM||||
1761950|NCT00135330|3234611|Superiority or Other|||||||0.039|||||||Mixed Model Repeated Measures (MMRM)||||
1761951|NCT00135330|3234615|Superiority or Other|||||||0.348|||||||ANCOVA||||
1761952|NCT00135330|3234616|Superiority or Other|||||||0.465|||||||ANCOVA||||
1761953|NCT00135330|3234617|Superiority or Other|||||||0.252|||||||ANCOVA||||
1761954|NCT00135330|3234618|Superiority or Other|||||||0.079|||||||ANCOVA||||
1761955|NCT00135330|3234619|Superiority or Other|||||||0.308|||||||ANCOVA||||
1761956|NCT00135330|3234620|Superiority or Other|||||||0.004|||||||ANCOVA||||
1761957|NCT00135330|3234621|Superiority or Other|||||||0.282|||||||ANCOVA|||The ratio of the ASI-iAUC at Week 20 to that at baseline was compared between the treatment groups.|
1761958|NCT00135226|3234622|Other||Rate Ratio|0.84|||||2-Sided|95.0|0.63|1.12|||||||
1761959|NCT00135226|3234623|Other||Rate Ratio|1.23|||||2-Sided|95.0|0.98|1.54|||||||
1761960|NCT00135226|3234624|Other||Rate Ratio|0.78|||||2-Sided|95.0|0.46|1.31|||||||
1761961|NCT00135226|3234624|Other||Rate Ratio|0.84|||||2-Sided|95.0|0.5|1.41|||||||
1761962|NCT00135226|3234625|Other||Rate Ratio|0.72|||||2-Sided|95.0|0.42|1.22|||||||
1761963|NCT00135226|3234625|Other||Rate Ratio|0.83|||||2-Sided|95.0|0.49|1.41|||||||
1761964|NCT00135226|3234626|Other||Rate ratio|1.02|||||2-Sided|95.0|0.7|1.48|||||||
1761965|NCT00135226|3234626|Other||Rate Ratio|0.85|||||2-Sided|95.0|0.58|1.23|||||||
1761966|NCT00135226|3234627|Other||Rate Ratio|1.14|||||2-Sided|95.0|0.86|1.52|||||||
1761967|NCT00135226|3234627|Other||Rate Ratio|1.01|||||2-Sided|95.0|0.76|1.34|||||||
1761968|NCT00135226|3234628|Other||Rate Ratio|1.17|||||2-Sided|95.0|0.87|1.58|||||||
1761969|NCT00135226|3234628|Other||Rate Ratio|1.02|||||2-Sided|95.0|0.76|1.38|||||||
1761970|NCT00135226|3234629|Other||Rate Ratio|1.07|||||2-Sided|95.0|0.91|1.25|||||||
1761971|NCT00135226|3234629|Other||Rate Ratio|1.13|||||2-Sided|95.0|0.97|1.32|||||||
1761972|NCT00135226|3234630|Other||Rate Ratio|1.04|||||2-Sided|95.0|0.79|1.37|||||||
1761982|NCT00135226|3234635|Other||Rate Ratio|0.8|||||2-Sided|95.0|0.64|1.01|||||||
1761983|NCT00135226|3234636|Other||Rate Ratio|0.93|||||2-Sided|95.0|0.68|1.28|||||||
1761984|NCT00135226|3234636|Other||Rate ratio|1.19|||||2-Sided|95.0|0.86|1.63|||||||
1761985|NCT00135226|3234637|Other||Rate ratio|0.95|||||2-Sided|95.0|0.82|1.12|||||||
1761986|NCT00135226|3234637|Other||Rate Ratio|0.98|||||2-Sided|95.0|0.84|1.15|||||||
1761987|NCT00135226|3234638|Other||Rate Ratio|0.8|||||2-Sided|95.0|0.57|1.12|||||||
1761988|NCT00135226|3234638|Other||Rate Ratio|0.96|||||2-Sided|95.0|0.68|1.34|||||||
1761989|NCT00135226|3234639|Other||Rate Ratio|0.94|||||2-Sided|95.0|0.59|1.5|||||||
1761990|NCT00135226|3234639|Other||Rate Ratio|1.12|||||2-Sided|95.0|0.7|1.77|||||||
1761991|NCT00135226|3234640|Other||Rate ratio|0.79|||||2-Sided|95.0|0.61|1.02|||||||
1761992|NCT00135226|3234640|Other||Rate Ratio|0.86|||||2-Sided|95.0|0.66|1.12|||||||
1761993|NCT00135226|3234641|Other||Risk Ratio|0.95|||||2-Sided|95.0|0.86|1.05|||||||
1761994|NCT00135226|3234641|Other||Rate Ratio|0.94|||||2-Sided|95.0|0.85|1.04|||||||
1761995|NCT00135226|3234642|Other||Rate Ratio|0.99|||||2-Sided|95.0|0.8|1.24|||||||
1761996|NCT00135226|3234643|Other||Rate Ratio|1.0|||||2-Sided|95.0|0.91|1.09|||||||
1761997|NCT00135226|3234643|Other||Rate Ratio|0.88|||||2-Sided|95.0|0.8|0.97|||||||
1761998|NCT00135226|3234644|Other||Rate Ratio|1.29||||0.003|2-Sided|95.0|1.09|1.52|||Log Rank||||
1761999|NCT00135226|3234645|Other||Rate Ratio|0.97||||0.55|2-Sided|95.0|0.87|1.08|||Log Rank||||
1762000|NCT00135226|3234645|Other||Rate Ratio|0.88||||0.01|2-Sided|95.0|0.79|0.97|||Log Rank||||
1762001|NCT00134563|3234695|Superiority or Other|||||||0.3861||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means|||
1762002|NCT00134563|3234695|Superiority or Other|||||||0.8271||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means|||
1762003|NCT00134563|3234698|Superiority or Other|||||||0.0317||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||Mixed-effect model with repeated measures [MMRM] on cubic root transformed total lesion volume data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value (cubic root transformed) and baseline-by-visit interaction).|
1762004|NCT00134563|3234698|Superiority or Other|||||||0.0003||||||"A priori threshold for statistical significance ≤0.05~No adjustment for multiple comparisons"|t-test, 2 sided|2-sided t-test on baseline adjusted least-square means||Mixed-effect model with repeated measures [MMRM] on cubic root transformed total lesion volume data (treatment group, region of enrollment, baseline EDSS stratum, visit, treatment-by-visit interaction, baseline value (cubic root transformed) and baseline-by-visit interaction).|
1762005|NCT00134563|3234699|Superiority or Other||Hazard ratio reduction (%)|23.7||||0.0835||||||"Step down approach:~H1 tested only if both comparisons on the primary outcome measure were statistically significant~H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative risk reduction with Teriflunomide 7 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)||
1762006|NCT00134563|3234699|Superiority or Other||Hazard ratio reduction (%)|29.8||||0.0279||||||"Step down approach:~H1 tested only if both comparisons on the primary outcome measure were statistically significant~H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance ≤0.05"|Log Rank|Two-sided Log-rank test stratified by region of enrollment and baseline EDSS stratum|Relative risk reduction with Teriflunomide 14 mg compared to placebo (estimated from a Cox proportional hazard model with treatment arm, region of enrollment and baseline EDSS stratum as covariates)|"Null hypothesis:~H1: No difference between Teriflunomide 14 mg and placebo~H2: No difference between Teriflunomide 7 mg and placebo~The study was also sized to detect a 37% hazard rate reduction of an assumed disability progression hazard rate of 0.1783 in the placebo group and 0.1116 in the teriflunomide group by the end of 2 years with a power of 80% anticipating a potential 20% 2-year dropout rate."|
1762007|NCT00134563|3234700|Superiority or Other||Relative Risk Reduction (%)|31.2||||0.0002||||||"Step down approach used to adjust for multiplicity:~H1 tested first~H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with Teriflunomide 7 mg compared to placebo||
1762008|NCT00134563|3234700|Superiority or Other||Relative risk reduction (%)|31.5||||0.0005||||||"Step down approach used to adjust for multiplicity:~H1 tested first~H2 tested only if the comparison H1 was statistically significant~A priori threshold for statistical significance for both comparisons ≤0.05"|Regression, Poisson||Relative risk reduction with Teriflunomide 14 mg compared to placebo|"Null hypothesis:~H1: No difference between Teriflunomide 14 mg and placebo~H2: No difference between Teriflunomide 7 mg and placebo~The study was sized to detect a 25% relative risk reduction with teriflunomide in the 2-year relapse rate at a significance level of 0.050 with a power ≥95% anticipating a potential 20% 2-year dropout rate."|
1762009|NCT00134056|3234718|Superiority or Other||Hazard Ratio (HR)|1.02||||0.81|2-Sided|95.0|0.89|1.16|||Log Rank|||The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 6.0 months to 7.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.|
1762010|NCT00134056|3234719|Superiority or Other||Hazard Ratio (HR)|1.04||||0.64|2-Sided|95.0|0.9|1.19|||Log Rank|||The primary analysis was by intention to treat and the Hochberg procedure was used for multiple testing of co-primary endpoints. Assuming a 4 year accrual, 2.5 years of follow-up, and 930 eligible patients, the study was designed to have 87% power to detect a 25% increase from 18.0 months to 22.5 months in median overall survival with a one-sided log rank with alpha of 0.0125.|
1762011|NCT00133952|3234740|Superiority or Other||Odds Ratio (OR)|1.16||||0.749|2-Sided|95.0|0.46|2.92|||Cochran-Mantel-Haenszel||||
1762012|NCT00133952|3234742|Superiority or Other||Odds Ratio (OR)|0.68||||0.203|2-Sided|95.0|0.37|1.23|||Cochran-Mantel-Haenszel||||
1762013|NCT00133952|3234743|Superiority or Other|||||||0.663|||||||ANCOVA||||
1762014|NCT00133952|3234744|Superiority or Other||LS Mean difference|0.5||||0.344|2-Sided|95.0|-0.6|1.6|||Mixed models repeated measures||||
1762015|NCT00133952|3234746|Superiority or Other||Odds Ratio (OR)|0.99||||0.971|2-Sided|95.0|0.68|1.44|||Cochran-Mantel-Haenszel||||
1762016|NCT00133952|3234747|Superiority or Other||LS Mean difference|-3.3||||0.616|2-Sided|95.0|-16.5|9.8|||Mixed models repeated measures||||
1762017|NCT00133952|3234748|Superiority or Other||Odds Ratio (OR)|0.63||||0.724|2-Sided|95.0|0.15|2.67|||Fisher Exact||||
1762018|NCT00132769|3234780|Superiority or Other||LS mean ratio between treatments|0.84||||0.225|2-Sided|95.0|0.63|1.12|||ANCOVA||||
1762019|NCT00132769|3234787|Superiority or Other||Difference in Percent|-5.66||||0.543|2-Sided|95.0|-24.45|13.13|||Cochran-Mantel-Haenszel||||
1762020|NCT00132769|3234788|Superiority or Other||Difference in LS Mean|1.48||||0.278|2-Sided|95.0|-1.21|4.18|||ANCOVA||||
1762021|NCT00132691|3234798|Superiority or Other||Hazard Ratio (HR)|0.26||||0.24|2-Sided|95.0|0.03|2.44||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of diabetes mellitus for the implant and systemic treatments. The systemic treatment is the reference group.||
1762022|NCT00132691|3234799|Superiority or Other||Hazard Ratio (HR)|0.4||||0.13|2-Sided|95.0|0.13|1.29||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of hypertension for the implant and systemic treatments. The systemic treatment is the reference group.||
1762023|NCT00132691|3234800|Superiority or Other||Hazard Ratio (HR)|0.91||||0.84|2-Sided|95.0|0.39|2.15||unadjusted|Regression, Cox||A Cox proportional hazards model was used to evaluate the relative hazard of hyperlipidemia for the implant and systemic treatments. The systemic treatment is the reference group.||
1762024|NCT00132691|3234801|Superiority or Other||Mean Difference (Net)|2.95|Standard Error of the Mean|1.23||0.016|2-Sided|95.0|0.54|5.36||unadjusted|Generalized Estimating Equations||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).||
1762025|NCT00132691|3234802|Superiority or Other||Mean Difference (Net)|3.62|Standard Error of the Mean|1.6||0.023|2-Sided|95.0|0.49|6.76||unadjusted|GEE, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic)||
1762026|NCT00132691|3234803|Superiority or Other||Mean Difference (Net)|4.64|Standard Error of the Mean|2.3||0.043|2-Sided|95.0|0.14|9.15||unadjusted|GEE, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).||
1762027|NCT00132691|3234804|Superiority or Other||Hazard Ratio (HR)|4.12|||<|0.0001|2-Sided|95.0|2.21|7.67||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of developing a cataract. The systemic arm was the reference group.||
1762028|NCT00132691|3234805|Superiority or Other||Hazard Ratio (HR)|8.4|||<|0.0001|2-Sided|95.0|3.39|20.82||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of having surgery to lower IOP. The systemic arm was the reference group.||
1762029|NCT00132691|3234806|Superiority or Other||Hazard Ratio (HR)|4.16|||<|0.0001|2-Sided|95.0|2.67|6.47||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of using an IOP-lowering therapy. The systemic arm was the reference group.||
1762030|NCT00132691|3234807|Superiority or Other||Hazard Ratio (HR)|4.19||||0.0008|2-Sided|95.0|1.82|9.63||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of developing glaucoma. The systemic arm was the reference group.||
1762031|NCT00132691|3234808|Superiority or Other||Hazard Ratio (HR)|4.28|||<|0.0001|2-Sided|95.0|2.78|6.58||unadjusted|Cox proportional hazards with RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP that was 10mmHg or greater than the baseline value. The systemic arm was the reference group.||
1762032|NCT00132691|3234809|Superiority or Other||Hazard Ratio (HR)|3.59|||<|0.0001|2-Sided|95.0|2.34|5.5||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP of 24 mmHg or greater. The systemic arm was the reference group||
1762033|NCT00132691|3234810|Superiority or Other||Hazard Ratio (HR)|6.08|||<|0.0001|2-Sided|95.0|3.32|11.15||unadjusted|Cox proportional hazards w/ RE||A Cox proportional hazards model with a random effect to account for between-eye correlation was used to estimate the relative hazard of experiencing an IOP of 30 mmHg or greater. The systemic arm was the reference group.||
1762034|NCT00132691|3234811|Superiority or Other||Ratio of odds ratios|0.29||||0.001|2-Sided|95.0|0.13|0.6||unadjusted|GEE, logistic||For each treatment group the odds of uveitis activity at 2 years as compared to baseline was computed. The treatment effect represents the ratio of these odds (implant divided by systemic).||
1762035|NCT00132691|3234812|Superiority or Other||Ratio of odds ratios|0.61||||0.071|2-Sided|95.0|0.34|1.03||unadjusted|GEE, logistic||For each treatment group the odds of macular edema at 2 yrs as compared to baseline was computed. The treatment effect is the ratio of these odds (implant divided by systemic).||
1762064|NCT00131508|3234874|Superiority or Other|||||||0.99|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported emotional function in the placebo and glutamine groups.|
1762065|NCT00131508|3234874|Superiority or Other|||||||0.82|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported physical function in the placebo and glutamine groups.|
1762126|NCT00129961|3234974|Superiority or Other|||||||0.015|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata|||
1762036|NCT00132691|3234813|Superiority or Other||Mean Difference (Net)|2.79|Standard Error of the Mean|2.03||0.16|2-Sided|95.0|-1.16|6.68||unadjusted|Generalized estimating equations, linear||The treatment effect is a model-based comparison of within group treatment change from enrollment to 24 months (the difference of the differences - implant minus systemic).|"Null hypothesis: There will be no difference in change in visual acuity between treatment groups.~Assuming 67% bilateral disease, between eye correlation of 0.4, SD of 16 letters’ change over 2 years and two-sided type 1 error rate of .05, a sample size of 250 provided 91% power (assuming 10% crossover) to detect a treatment difference of 7.5 standard ETDRS letters’ change in visual acuity from baseline to 24 months."|
1762037|NCT00132678|3234814|Superiority or Other||Mean Difference (Final Values)|-2.0|Standard Error of the Mean|0.87||0.02||95.0|-3.75|-0.32|||ANCOVA|ANCOVA model with factors for treatment and country and double-blind baseline value as covariate.|Change in RISPERDAL CONSTA arm minus change in placebo arm.||
1762038|NCT00132678|3234815|Superiority or Other||Mean Difference (Final Values)|-5.9|Standard Error of the Mean|1.09|<|0.001||95.0|-8.08|-3.79|||ANCOVA|ANCOVA model with factors for treatment and country and double-blind baseline value as covariate.|Change in RISPERDAL CONSTA arm minus change in placebo arm.||
1762039|NCT00132678|3234816|Superiority or Other||Hazard Ratio (HR)|0.4|||<|0.001||95.0|0.27|0.59|||Log Rank|Adjusting for country|RISPERDAL CONSTA hazard in numerator, placebo hazard in denominator.||
1762040|NCT00132314|3234818|Superiority or Other||Hazard Ratio (HR)|0.87|||||2-Sided|95.0|0.63|1.2|||||||
1762041|NCT00132314|3234819|Superiority or Other||Hazard Ratio (HR)|0.87||||0.39|2-Sided|95.0|0.63|1.2|||Log Rank|||Time-to-event analysis; The primary outcome hypothesis is tested using a two-sided log-rank test to compare the hazard rate for the IM treatment group to that for the oral treatment group.|
1762042|NCT00132301|3234820|Superiority||Hazard Ratio (HR)|0.8||||0.4|2-Sided|95.0|0.58|1.11||Log rank test stratified by site.|Log Rank||||
1762043|NCT00132132|3234821|Superiority or Other|||||||0.02|||||||Chi-squared||||
1762044|NCT00132132|3234822|Superiority or Other|||||||0.006|||||||t-test, 2 sided|Per protocol adjusted for age and paternal education. Given the small number of participants with complete data, this model may be overfit.|||
1762045|NCT00132132|3234822|Superiority or Other|||||||0.14|||||||t-test, 2 sided|Age adjusted per protocol|||
1762046|NCT00132132|3234822|Superiority or Other|||||||0.03|||||||t-test, 2 sided|This analysis is the per protocol unadjusted value|||
1762047|NCT00131508|3234869|Superiority or Other|||||||0.4|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in hand grip between the placebo and glutamine groups.|
1762048|NCT00131508|3234870|Superiority or Other|||||||0.83|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in pulse rate between the placebo and glutamine groups.|
1762049|NCT00131508|3234871|Superiority or Other|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||We test the null hypothesis that the median difference in weight percentile between baseline and 12 months differs between the Glutamine and Placebo groups.|
1762050|NCT00131508|3234871|Superiority or Other|||||||1|||||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.|
1762051|NCT00131508|3234871|Superiority or Other|||||||0.56|||||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.|
1762052|NCT00131508|3234872|Superiority or Other|||||||0.93|||||||Wilcoxon (Mann-Whitney)|||We test the null hypothesis that the median difference in height percentile between baseline and 12 months differs between the Glutamine and Placebo groups.|
1762053|NCT00131508|3234872|Superiority or Other|||||||0.75|||||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.|
1762054|NCT00131508|3234872|Superiority or Other|||||||0.69|||||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.|
1762055|NCT00131508|3234873|Superiority or Other|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months differs between the Glutamine and Placebo groups.|
1762056|NCT00131508|3234873|Superiority or Other|||||||0.81|||||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.|
1762057|NCT00131508|3234873|Superiority or Other|||||||0.2|||||||Wilcoxon Signed Rank Test|||We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.|
1762058|NCT00131508|3234874|Superiority or Other|||||||0.84|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported school function in the placebo and glutamine groups.|
1762059|NCT00131508|3234874|Superiority or Other|||||||0.46|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported social function in the placebo and glutamine groups.|
1762060|NCT00131508|3234874|Superiority or Other|||||||0.45|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported emotional function in the placebo and glutamine groups.|
1762061|NCT00131508|3234874|Superiority or Other|||||||0.5|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month patient reported physical function in the placebo and glutamine groups.|
1762062|NCT00131508|3234874|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported school function in the placebo and glutamine groups.|
1762063|NCT00131508|3234874|Superiority or Other|||||||0.3|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline patient reported social function in the placebo and glutamine groups.|
1762066|NCT00131508|3234874|Superiority or Other|||||||0.69|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported school function in the placebo and glutamine groups.|
1762067|NCT00131508|3234874|Superiority or Other|||||||0.55|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported social function in the placebo and glutamine groups.|
1762068|NCT00131508|3234874|Superiority or Other|||||||0.65|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported emotional function in the placebo and glutamine groups.|
1762069|NCT00131508|3234874|Superiority or Other|||||||0.61|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between 12 month parent reported physical function in the placebo and glutamine groups.|
1762070|NCT00131508|3234874|Superiority or Other|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported school function in the placebo and glutamine groups.|
1762071|NCT00131508|3234874|Superiority or Other|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported social function in the placebo and glutamine groups.|
1762072|NCT00131508|3234874|Superiority or Other|||||||0.14|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported emotional function in the placebo and glutamine groups.|
1762073|NCT00131508|3234874|Superiority or Other|||||||0.62|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change between baseline parent reported physical function in the placebo and glutamine groups.|
1762074|NCT00131508|3234875|Superiority or Other|||||||0.24|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in red blood cell glutamine between the placebo and glutamine groups.|
1762075|NCT00131508|3234876|Superiority or Other|||||||0.53|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change of body mass index between the placebo and glutamine groups.|
1762076|NCT00131508|3234877|Superiority or Other|||||||0.17|||||||Wilcoxon (Mann-Whitney)|||We tested for a significant difference in the median change in REE ratio between the placebo and glutamine groups. The study was designed to provide 80% power at an alpha level of 0.05 for this objective. Due to slow accrual, the sample size of 46 participants required to obtain the designed power of the study was not realized.|
1762077|NCT00131456|3234880|Superiority or Other||||||<|0.01|||||||Regression, Logistic|||Logistic regression was used to analyze all dichotomous outcomes. The dichotomous primary outcome marijuana abstinence was modeled using independent predictors: treatment(Venlafaxine vs. Placebo) and baseline urine THC level. The initial analysis included an interaction between treatment and baseline urine THC levels which was deemed not significant and omitted from the final logistic model.|
1762078|NCT00131352|3234888|Superiority or Other||Odds Ratio (OR)|0.69||||0.156|2-Sided|95.0|0.41|1.16|||Generalized Estimating Equations (GEE)|||Estimate of Odds Ratio (Placebo/Synvisc-One) using Responder classification data at Week 26.|
1762079|NCT00131352|3234889|Superiority or Other||Odds Ratio (OR)|0.56||||0.025|2-Sided|95.0|0.34|0.93|||Generalized Estimating Equations (GEE)|||Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using COGA data at Week 26.|
1762080|NCT00131352|3234890|Superiority or Other||Odds Ratio (OR)|0.51||||0.005|2-Sided|95.0|0.31|0.82|||Generalized Estimating Equations (GEE)|||Model-based estimate of Odds Ratio (Placebo/Synvisc-One) using PTGA data at Week 26.|
1762081|NCT00131352|3234891|Superiority or Other|||||||0.266|||||||ANCOVA||||
1762082|NCT00131352|3234892|Superiority or Other|||||||0.679|||||||ANCOVA||||
1762083|NCT00131352|3234893|Superiority or Other||Odds Ratio (OR)|0.56||||0.022|2-Sided|95.0|0.35|0.92|||Generalized Estimating Equations (GEE)|||Estimate of Odds Ratio (Placebo/Synvisc-One) using WOMAC A1 data at Week 26.|
1762084|NCT00131352|3234894|Superiority or Other|||||||0.064|||||||ANCOVA||||
1762085|NCT00131352|3234895|Superiority or Other|||||||0.047|||||||ANCOVA|The repeated measures ANCOVA model included terms for treatment, site, time and time-by-treatment interaction; the baseline score was a covariate.|||
1762086|NCT00130923|3234897|Superiority|||||||0.003|||||||Chi-squared|Statistical test of hypothesis. Value of the Chi-squared statistic is 9.08|||
1762087|NCT00130923|3234898|Superiority||difference in treatment means|0.93|Standard Error of the Mean|1.19||0.44|2-Sided||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.||
1762088|NCT00130923|3234899|Superiority||difference in treatment means|2.65|Standard Error of the Mean|2.68||0.32|2-Sided||||||Mixed Models Analysis||We report the estimated coefficient difference in treatment means in a mixed model and its standard error.||
1762089|NCT00130923|3234900|Superiority||difference in treatment means|0.056|Standard Error of the Mean|0.099||0.57|2-Sided||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.||
1762090|NCT00130923|3234901|Superiority||Difference in treatment means|-0.62|Standard Error of the Mean|0.29||0.035|2-Sided||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.||
1762091|NCT00130923|3234902|Superiority||difference in treatment slopes|-0.043|Standard Error of the Mean|0.021||0.054|2-Sided||||||Mixed Models Analysis||We report the estimated coefficient for difference in treatment slopes in a mixed model and its standard error.||
1762092|NCT00130832|3234904|Non-Inferiority or Equivalence|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve 3-fold rise in serum anti-rotavirus IgA greater than -10%.|Percentage Point Difference|-4.4||||0.002||95.0|-8.0|-1.4|||Miettinen and Nurminen's|Comparing percentage difference with the non-inferiority margin of 10 percentage point with Miettinen and Nurminen's method.|Percentage point difference (concomitant – staggered)||
1762093|NCT00130832|3234904|Non-Inferiority or Equivalence|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the GMT ratio (concomitant group over staggered group) greater than 0.50.|GMT Ratio|0.54||||0.277||95.0|0.42|0.69|||ANOVA|ANOVA model on log titer of serum anti-rotavirus IgA|||
1762125|NCT00129961|3234973|Superiority or Other|||||||0.799|||||||Chi-squared||||
1762094|NCT00130832|3234905|Non-Inferiority or Equivalence|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers [NA] ≥1:8 greater than -10%.|Seroprotection Rate Difference|-0.1|||<|0.001||95.0|-2.3|2.3|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers [NA] ≥1:8) for poliovirus type 3|
1762095|NCT00130832|3234905|Non-Inferiority or Equivalence|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers [NA] ≥1:8 greater than -10%.|Seroprotection Rate Difference|0.0|||<|0.001||95.0|-1.4|1.6|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers [NA] ≥1:8) for poliovirus type 2|
1762096|NCT00130832|3234905|Non-Inferiority or Equivalence|non-inferiority criterion is that the lower limit of the 2-sided 95% confidence interval of the proportion difference (concomitant group minus staggered group) for subjects who achieve neutralizing antibody titers [NA] ≥1:8 greater than -10%.|Seroprotection Rate Difference|-0.5|||<|0.001||95.0|-2.2|1.4|||Miettinen and Nurminen's|Comparing seroprotection rate difference with the non-inferiority margin of 0.10 with Miettinen and Nurminen's method.||Seroprotection rate (proportion of subjects who achieve the seroprotection criteria: neutralizing antibody titers [NA] ≥1:8) for poliovirus type 1|
1762097|NCT00130728|3234911|Superiority or Other (legacy)||Percentage difference|6.4||||0.0068||95.0|1.8|11.3||Relative to placebo arm|Mantel Haenszel||Difference in objective response rates relative to placebo arm||
1762098|NCT00130728|3234912|Superiority or Other (legacy)||Hazard Ratio (HR)|0.623|||<|0.0001||95.0|0.519|0.748||relative to placebo arm|Log Rank||Stratified analysis; hazard ratio is relative to placebo arm.||
1762099|NCT00130728|3234913|Superiority or Other (legacy)||Hazard Ratio (HR)|0.97||||0.7583||95.0|0.799|1.177||relative to placebo arm|Log Rank||Stratified analysis; Hazard ratio is relative to placebo arm.||
1762100|NCT00130247|3234928|Non-Inferiority or Equivalence|This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.|Risk Difference (RD)|0.054||||||95.0|0.01|0.1|||||Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.||
1762101|NCT00130247|3234934|Superiority or Other||Incident rate ratio|4.52||||||95.0|1.29|15.9||||||Rate of relapse at 2 years. All patients adherent with treatment and remaining in follow-up at 2 years were included in the calculation of the relapse incidence rate.|
1762102|NCT00130247|3234934|Superiority or Other||Incidence rate ratio|3.43||||||95.0|0.94|12.5||||||Rate of relapse at 1 year. All patients adherent with treatment and remaining in follow-up at 1 year were included in the calculation of the relapse incidence rate.|
1762103|NCT00130247|3234937|Non-Inferiority or Equivalence|This two-sided equivalence trial compared the efficacy of 4 and 6 months of treatment. We assumed that the risk of relapse for patients in the 6 month arm was 3.5% and that an absolute difference of 5% (i.e. relapse rate of 8.5%) was clinically meaningful. For a level of significance of 0.05 and 80% power (two sided), we estimated that 284 evaluable subjects per arm were required.|Risk Difference (RD)|0.051||||||95.0|0.01|0.09|||||Confidence interval for difference of binomial proportions adjusted with Hauck Anderson continuity correction.|Comparison of binomial proportion of relapse: Intention-to-treat|
1762104|NCT00130117|3234948|Superiority or Other||Median Difference (Final Values)|0.6||||0.02|2-Sided|||||"p value reflects treatment of leptin for on-treatment, n=4"|ANOVA||||
1762105|NCT00130117|3234949|Superiority|||||||0.049|||||||ANOVA||||
1762106|NCT00130117|3234949|Superiority or Other|||||||0.024|||||||ANOVA||||
1762107|NCT00129961|3234962|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1762108|NCT00129961|3234963|Superiority or Other|||||||0.999|||||||Fisher Exact||||
1762109|NCT00129961|3234964|Superiority or Other|||||||0.588|||||||Fisher Exact||||
1762110|NCT00129961|3234965|Superiority or Other|||||||0.999|||||||Fisher Exact||||
1762111|NCT00129961|3234966|Superiority or Other|||||||0.672|||||||ANCOVA||||
1762112|NCT00129961|3234967|Superiority or Other|||||||0.604|||||||ANCOVA||||
1762113|NCT00129961|3234970|Superiority or Other|||||||0.425|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata|||
1762114|NCT00129961|3234971|Superiority or Other|||||||0.748|||||||Poisson regression||||
1762115|NCT00129961|3234972|Superiority or Other|||||||0.227|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Infiltrative|
1762116|NCT00129961|3234972|Superiority or Other|||||||0.72|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Nodular|
1762117|NCT00129961|3234972|Superiority or Other|||||||0.094|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||BCC Superficial|
1762118|NCT00129961|3234972|Superiority or Other|||||||0.004|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive without Perineural Invasion|
1762119|NCT00129961|3234972|Superiority or Other|||||||0.463|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive with Perineural Invasion|
1762120|NCT00129961|3234972|Superiority or Other|||||||0.012|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC In Situ|
1762121|NCT00129961|3234972|Superiority or Other|||||||0.018|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Invasive|
1762122|NCT00129961|3234972|Superiority or Other|||||||0.905|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Poorly differentiated|
1762123|NCT00129961|3234972|Superiority or Other|||||||0.491|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Moderately differentiated|
1762124|NCT00129961|3234972|Superiority or Other|||||||0.014|||||||Cochran-Mantel-Haenszel|Stratified by baseline lesion strata||SCC Well differentiated|
1762127|NCT00129961|3234975|Superiority or Other|||||||0.047|||||||Regression, Cox|Stratified by baseline lesions|||
1762128|NCT00129961|3234976|Superiority or Other|||||||0.022||||||Poisson regression was used to model NMSC counts using the years in study as an offset. The generalized estimated equations (GEE) approach was used to estimate parameters and compare treatment differences.|Poisson regression|Adjusted by baseline strata; Poisson model = strata + treatment.|||
1762129|NCT00129766|3234989|Non-Inferiority or Equivalence|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.652||||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Van Eleteren test||||
1762130|NCT00129766|3234990|Non-Inferiority or Equivalence|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.493||||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Van Eleteren test||||
1762131|NCT00129766|3234991|Non-Inferiority or Equivalence|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.476|||||||Van Eleteren test|Test stratified by presence or absence of CLD of prematurity specified on the CRF||P-value is for overall incidence|
1762132|NCT00129766|3234992|Non-Inferiority or Equivalence|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.005||||||No adjustment for multiple comparisons.|Cochran-Mantel-Haenszel|The CMH test was stratified by presence or absence of CLD of prematurity as specified on the CRF|||
1762133|NCT00129766|3234993|Non-Inferiority or Equivalence|A CMH approach stratified by presence or absence of CLD of prematurity requiring medical intervention was used.||||||0.11||||||Test stratified by presence or absence of CLD of prematurity specified on the CRF|Cochran-Mantel-Haenszel||||
1762134|NCT00129766|3235002|Non-Inferiority or Equivalence|Confidence interval and relative risk adjusted for the stratification factor of presence or absence of CLD of prematurity as specified on the CRF.|Risk Ratio (RR)|0.74|||||2-Sided|95.0|0.503|1.083|||||Relative risk was calculated as (Pn/Ps) where Pn is the proportion of patients with RSV hospitalization in the motavizumab group and Ps is the proportion of patients with RSV hospitalization in the palivizumab group.|ITT population|
1762135|NCT00129701|3235010|Superiority|||||||0.064|||||||Wilcoxon (Mann-Whitney)||||
1762136|NCT00129649|3235011|Superiority|||||||0.004|||||||Chi-squared||||
1762137|NCT00129623|3235014|Superiority or Other||Odds Ratio (OR)|13.8|||||2-Sided|95.0|5.17|36.79||||||Lumbar Spine and Proximal Femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable, and treatment group (oral IBN150 mg/Placebo) and time since menopause as the independent variables. An OR of >1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.|
1762138|NCT00129623|3235014|Superiority or Other||Odds Ratio (OR)|8.59|||||2-Sided|95.0|3.8|19.42||||||Proximal femur BMD: The adjusted treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg once monthly/Placebo) and time since menopause as the independent variables. An OR of >1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.|
1762139|NCT00129623|3235014|Superiority or Other||Odds Ratio (OR)|12.51|||||2-Sided|95.0|5.12|30.56||||||Lumbar BMD: Adjusted treatment effect - The treatment effect and 95% C.I. were represented by presenting OR. These were estimated by fitting a logistic regression model, with responder outcome (responder/non-responder) as the dependent variable and the treatment group (oral IBN 150 mg/Placebo) and time since menopause as the independent variables. An OR of >1 indicated participants treated with IBN were more likely to have BMD above or equal to baseline relative to those treated with placebo.|
1762140|NCT00129623|3235020|Superiority or Other||Mean Difference (Net)|4.1226|||<|0.0001|2-Sided|95.0|2.9613|5.2838||The primary analysis was an ANOVA (two way classification), including treatment group and time since menopause (as a binary variable; 0.5-3 years, >3 years) as independent factors.|ANOVA|||"H0 (null hypothesis): There was no statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD).~H1 (alternative hypothesis): There was a statistically significant difference between monthly treatment with 150 mg oral IBN and monthly treatment with placebo in relative change from baseline of mean lumbar spine (L2-L4 BMD)."|
1762141|NCT00129545|3235023|Non-Inferiority or Equivalence|The posterior probability of non-inferiority is defined as the probability that the event rate for the Device group is less than twice that for the Control group. This probability was required to be greater than 0.975 for a finding of non-inferiority. The criterion for non-inferiority was consistently met at each analysis time point demonstrating the Device group is non-inferior to the Control group.|Risk Ratio (RR)|0.61|||||2-Sided|95.0|0.42|1.07|||||Relative Risk calculated as Device Rate over Control rate, with 95% Credible Intervals||
1762142|NCT00129441|3235030|Superiority or Other||||||<|0.05|||||||ANOVA||||
1762143|NCT00129441|3235031|Superiority or Other||||||<|0.05|||||||ANOVA||||
1762144|NCT00129441|3235032|Superiority or Other|||||||0.01|||||||ANOVA|||At week 4, mean BPRS total scores were nearly the same for the placebo group and L-830982 group as a result of a significant reduction in positive symptoms reported for the placebo group (F=9.12, df=1,13, p=0.01). For the L-830982-treated group, neither total BPRS scores nor any of the factor scores changed over the course of the trial.|
1762145|NCT00129441|3235033|Superiority or Other|||||||0.249|||||||ANOVA||||
1762146|NCT00129441|3235034|Superiority or Other|||||||0.05|||||||ANOVA||||
1762147|NCT00129441|3235035|Superiority or Other|||||||0.12|||||||ANOVA||||
1762148|NCT00129441|3235036|Superiority or Other|||||||0.162|||||||ANOVA||||
1762149|NCT00129441|3235037|Superiority or Other|||||||0.16|||||||ANOVA||||
1762150|NCT00129402|3235038|Superiority or Other|||||||0.95|||||||ANOVA||||
1762151|NCT00129402|3235039|Superiority or Other||||||<|0.01|||||||ANOVA||||
1762152|NCT00129402|3235040|Superiority or Other|||||||0.48|||||||non-parametric model||||
1762153|NCT00129402|3235041|Superiority or Other||||||<|0.01|||||||ANOVA||||
1762154|NCT00129402|3235042|Superiority or Other||||||<|0.01|||||||ANOVA||||
1762155|NCT00129402|3235043|Superiority or Other||||||<|0.01|||||||ANOVA||||
1762156|NCT00129259|3235058|Superiority or Other|||||||0.11|||||||ANCOVA|ANCOVA adjusts for baseline daily insulin use per kg||"Null hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg does not differ between the treatment and control groups.~Alternative hypothesis: The mean change from baseline to Month 24 in daily insulin use per kg differs between the treatment and control groups."|
1762157|NCT00129259|3235059|Superiority or Other|||||||0.697|||||||ANCOVA|ANCOVA adjusts for baseline HbA1c.||"Null hypothesis: The mean change in HbA1c from baseline (pre-treatment) to Month 24 does not differ between treatment groups.~Alternative hypothesis: The mean change in HbA1c from baseline to Month 24 differs between treatment groups."|
1762158|NCT00129259|3235060|Superiority or Other|||||||0.002|||||||ANCOVA|P-value for testing treatment effect uses change in ln(AUC+1) as the outcome variable and adjusts for baseline ln(AUC+1).||"Null hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC does not differ between treatment groups after adjusting for baseline C-peptide AUC.~Alternative hypothesis: The mean change from baseline to Month 24 in the 4-hour C-peptide AUC differs between the treatment groups after adjusting for baseline values."|
1762159|NCT00129220|3235065|Superiority or Other|||||||0.003||||||P-value for Maximum Change from Baseline.|Wilcoxon Rank Sum||||
1762160|NCT00129220|3235066|Superiority or Other||Mean Difference (Net)|-4.6||||0.136|2-Sided|95.0|-14.9|5.7||P-value for 6-Week Syndromic Depression Rate.|Cochran-Mantel-Haenszel||||
1762161|NCT00129220|3235067|Superiority or Other||Least Squares Mean Difference|-0.16||||0.855|2-Sided|95.0|-1.95|1.62||P-value for 6-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.||
1762162|NCT00129220|3235067|Superiority or Other||Least Squares Mean Difference|-1.48||||0.019|2-Sided|95.0|-2.71|-0.25||P-value for 3-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.||
1762163|NCT00129220|3235068|Superiority or Other||Mean Difference (Net)|-14.1||||0.014|2-Sided|95.0|-31.7|3.4||P-value for 6-Week Symptomatic Depression Rate.|Cochran-Mantel-Haenszel||||
1762164|NCT00129220|3235068|Superiority or Other||Mean Difference (Net)|0.8||||0.698|2-Sided|95.0|-3.2|4.9||P-value for 3-Week Symptomatic Depression Rate.|Cochran-Mantel-Haenszel||||
1762165|NCT00129220|3235069|Superiority or Other||Least Squares Mean Difference|0.3||||0.982|2-Sided|95.0|-21.3|21.8||P-value is for 6-Week Remission Rate|Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Haloperidol.||
1762166|NCT00129220|3235069|Superiority or Other||Least Squares Mean Difference|5.9||||0.384|2-Sided|95.0|-7.3|19.2||P-value for 3-Week Remission Rate.|Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Placebo.||
1762167|NCT00129220|3235070|Superiority or Other||Mean Difference (Net)|-1.3||||0.908|2-Sided|95.0|-21.0|18.4||P-value for 6-Week Response Rate.|Cochran-Mantel-Haenszel||||
1762168|NCT00129220|3235070|Superiority or Other||Mean Difference (Net)|6.7||||0.333|2-Sided|95.0|-6.7|20.1||P-value for 3-Week Response Rate.|Cochran-Mantel-Haenszel||||
1762169|NCT00129220|3235071|Superiority or Other||Least Squares Mean Difference|-0.13||||0.722|2-Sided|95.0|-0.82|0.57||P-value for 6-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.||
1762170|NCT00129220|3235071|Superiority or Other||Least Squares Mean Difference|-0.51||||0.006|2-Sided|95.0|-0.87|-0.15||P-value for 3-Week Change.|ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.||
1762171|NCT00129220|3235072|Superiority or Other||Least Squares Mean Difference|-0.47||||0.171|2-Sided|95.0|-1.15|0.21|||ANCOVA||Least Squares Mean Difference = Olanzapine minus Haloperidol.||
1762172|NCT00129220|3235073|Superiority or Other||Least Squares Mean Difference|21.0||||0.064|2-Sided|95.0|1.6|40.4|||Cochran-Mantel-Haenszel||Least Squares Mean Difference = Olanzapine minus Haloperidol.||
1762173|NCT00129220|3235074|Superiority or Other||Least Squares Mean Difference|-0.78||||0.774|2-Sided|95.0|-6.15|4.59|||ANCOVA||Least Squares Mean Difference = Olazapine minus Haloperidol.||
1762174|NCT00129220|3235075|Superiority or Other||Least Squares Mean Difference|-5.62|||<|0.001|2-Sided|95.0|-8.87|-2.37|||ANCOVA||Least Squares Mean Difference = Olanzapine minus Placebo.||
1762175|NCT00128713|3235219|Superiority or Other|||||||0.68||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons|||
1762176|NCT00128713|3235219|Superiority or Other|||||||0.82||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons|||
1762177|NCT00128713|3235219|Superiority or Other|||||||0.51||||||Each pair of treatment arms was compared using an exact version of the Mantel-Haenszel test for trend.|Mantel Haenszel|These tests will be carried out at the .017 significance level to adjust for the multiple comparisons|||
1762178|NCT00128713|3235221|Superiority or Other|||||||0.16||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1762179|NCT00128713|3235221|Superiority or Other||||||<|0.001||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1762180|NCT00128713|3235221|Superiority or Other||||||<|0.001||||||All analyses were carried out using intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1762181|NCT00128713|3235222|Superiority or Other||||||<|0.001||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1762182|NCT00128713|3235222|Superiority or Other||||||<|0.001||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1762183|NCT00128713|3235222|Superiority or Other||||||<|0.02||||||All analyses are based on intention to treat. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1762204|NCT00127790|3235427|Superiority or Other||Mean Difference (Final Values)|7.0||||0.01|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.|
1762184|NCT00128713|3235223|Superiority or Other|||||||0.66||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|||
1762185|NCT00128713|3235223|Superiority or Other|||||||0.83||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|||
1762186|NCT00128713|3235223|Superiority or Other|||||||0.83||||||Three one-degree-of-freedom chi-square tests, each comparing a pair of treatment groups. These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|Fisher Exact|These tests were carried out at the .017 significance level to adjust for the multiple comparisons.|||
1762187|NCT00128219|3235284|Superiority or Other||Odds Ratio (OR)|0.53||||0.256|2-Sided|95.0|0.18|1.45||The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.|Fisher Exact|Fisher's exact test was used to test no difference in proportion persistently colonized by arm against a two-sided alternative of a difference.|The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the two-sided 5% level Fisher’s exact test. The GBS III-TT arm is in the numerator and Td arm in the denominator, so a value <1 favors the GBS III-TT arm.|A two-sided 5% level Fisher’s exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher’s exact test was inverted to obtain a 95% confidence interval for the odds ratio.|
1762188|NCT00128219|3235285|Superiority or Other||Vaccine Efficacy, VE=1-RR=1-exp(ß)|36.0||||0.089||95.0|-7.0|61.0||Significance was set at .05 without adjustment for multiplicity. Exchangeable correlation structure and GEE were used for repeated measures.|Binomial regression, log-linear link|The Wald test of treatment effect was used to test no difference in proportion of GBS III pos. by arm against a 2-sided alternative of a difference.|Estimate of vaccine efficacy and 95% CI were obtained by transforming the estimate of log relative risk for treatment effect and the robust Wald CI in the log-linear binomial regression model fit to the proportion of vaginal type III GBS swabs.|The proportion of vaginal swabs that were GBS III culture positive was estimated from a GEE model fit with binomial family, log-link, and exchangeable correlation. Point and robust interval estimates for vaccine efficacy, were obtained by transforming those for treatment effect in this model, and used to test the hypothesis of no efficacy.|
1762189|NCT00128219|3235286|Superiority or Other||Odds Ratio (OR)|1.46||||0.12|2-Sided|95.0|0.917|2.34||The a priori threshold for statistical significance for the analysis of secondary endpoints was set at .05 without adjustment for multiplicity.|Fisher Exact|Fisher's exact test was used to test no difference in proportions always vaginal GBS-III negative by arm to a two-sided alternative of a difference.|The OR was calculated from the 2x2 contingency table, and the 95% CI was obtained by inverting the 2-sided 5% level Fisher’s exact, with GBS III-TT arm in the numerator and Td arm in the denominator so <1 favors the GBS III-TT arm.|A two-sided 5% level Fisher’s exact test was used to test the null hypothesis of no difference in proportion of participants who were vaginal type III GBS negative throughout the study between treatment arms. The two-sided 5% Fisher’s exact test was inverted to obtain a 95% confidence interval for the odds ratio.|
1762190|NCT00128219|3235311|Superiority or Other||Vaccine Efficacy, VE=1-RR=1-exp(ß)|36.0||||0.044|2-Sided|95.0|1.0|58.0||The a priori threshold for statistical significance was set at 0.05.|Regression, Cox|The study was multi-center, and the Cox model was stratified by geographic region of the participating clinical sites.|Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.|Time to first acquisition of vaginal type III GBS was analyzed by fitting a Cox Proportional Hazards model stratified by region to the data. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.|
1762191|NCT00128206|3235314|Superiority or Other||Risk Ratio (RR)|0.51|||>|0.05||95.0|0.13|2.01|||Chi-squared|||The null hypothesis was that there would be no difference in toxicity by study group, and a sample of 360 participants (180 in each group)was estimated to have sufficient power to detect a difference.|
1762192|NCT00128180|3235368|Superiority or Other|||||||0.18|||||||Fisher Exact||||
1762193|NCT00127790|3235424|Superiority or Other||Mean Difference (Final Values)|13.2||||0.015|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.|
1762194|NCT00127790|3235424|Superiority or Other||Mean Difference (Final Values)|7.4||||0.187|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.|
1762195|NCT00127790|3235424|Superiority or Other||Mean Difference (Final Values)|15.2||||0.016|||||||Generlaized Estimating Equations|||Two-tailed comparison of pre-post scores.|
1762196|NCT00127790|3235425|Superiority or Other||Mean Difference (Final Values)|0.0||||0.039|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.|
1762197|NCT00127790|3235425|Superiority or Other||Mean Difference (Final Values)|0.4||||0.786|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores|
1762198|NCT00127790|3235425|Superiority or Other||Mean Difference (Final Values)|0.5||||0.063|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores|
1762199|NCT00127790|3235426|Superiority or Other||Mean Difference (Final Values)|1.3||||0.737|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores|
1762200|NCT00127790|3235426|Superiority or Other||Mean Difference (Final Values)|-1.2||||0.112|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.|
1762201|NCT00127790|3235426|Superiority or Other||Mean Difference (Final Values)|3.5||||0.33|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.|
1762202|NCT00127790|3235427|Superiority or Other||Mean Difference (Final Values)|8.6||||0.011|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores|
1762203|NCT00127790|3235427|Superiority or Other||Mean Difference (Final Values)|0.5||||0.581|||||||Generalized Estimating Equations|||Two-tailed comparison of pre-post scores.|
1762205|NCT00127712|3235428|Superiority or Other|||||||0.79|||||||Wilcoxon (Mann-Whitney)||||
1762206|NCT00127712|3235429|Superiority or Other|||||||0.001|||||||Chi-squared||||
1762207|NCT00127712|3235430|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)||||
1762208|NCT00127712|3235431|Superiority or Other|||||||0.02|||||||Chi-squared||||
1762209|NCT00127608|3235434|Non-Inferiority or Equivalence|Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab)|Geometric mean Ratio|1.0|||||2-Sided|95.0|0.48|2.21||||||Geometric mean ratio of viral load (Vesicle fluid over Vesicle swab)|
1762210|NCT00127608|3235434|Non-Inferiority or Equivalence|Geometric mean ratio of viral load (Papule swab over Vesicle swab)|Geometric mean Ratio|0.37|||||2-Sided|95.0|0.17|0.79||||||Geometric mean ratio of viral load (Papule swab over Vesicle swab)|
1762211|NCT00127608|3235434|Non-Inferiority or Equivalence|Geometric mean ratio of viral load (Papule swab over Vesicle fluid)|Geometric mean ratio|0.36|||||2-Sided|95.0|0.17|0.76||||||Geometric mean ratio of viral load (Papule swab over Vesicle fluid)|
1762212|NCT00127608|3235434|Non-Inferiority or Equivalence|Difference in mean viral load (in log10) (Vesicle fluid minus Vesicle swab)|Mean Difference (Final Values)|0.00132||||0.9952|2-Sided|95.0|-0.3171|0.3435|||ANOVA|Tukey adjustments were made for the comparison.|||
1762213|NCT00127608|3235434|Non-Inferiority or Equivalence|Difference in mean viral load (in log10) (Papule swab minus Vesicle swab)|Median Difference (Final Values)|-0.432||||0.006|2-Sided|95.0|-0.7605|-0.1035|||ANOVA|Tukey adjustments were made for the comparison.|||
1762214|NCT00127608|3235434|Non-Inferiority or Equivalence|Difference in mean viral load (in log10) (Papule swab minus Vesicle fluid)|Mean Difference (Final Values)|-0.4451||||0.0038||95.0|-0.769|-0.1213|||ANOVA|Tukey adjustments were made for the comparison.|||
1762215|NCT00127608|3235435|Non-Inferiority|The mean viral load between samples stored in liquid and samples stored dry was compared.|Geometric Mean Ratio|0.33|||<|0.0001|||||||ANOVA|Tukey adjustments were made for all 2 by 2 comparisons.|The Geometric Mean Ratio of the viral load was calculated for dry over liquid storage condition.||
1762216|NCT00127439|3235439|Non-Inferiority or Equivalence|Previously provided||||||0.05|||||||t-test, 2 sided||||
1762217|NCT00127439|3235440|Non-Inferiority or Equivalence|Previously provided||||||0.05|||||||t-test, 2 sided||||
1762218|NCT00127439|3235441|Non-Inferiority or Equivalence|Previously provided||||||0.05|||||||t-test, 2 sided||||
1762219|NCT00127439|3235442|Non-Inferiority or Equivalence|Previously provided||||||0.05|||||||t-test, 2 sided||||
1762220|NCT00127439|3235443|Non-Inferiority or Equivalence|Previously provided||||||0.05|||||||t-test, 2 sided||||
1762221|NCT00127439|3235444|Non-Inferiority or Equivalence|Provided previously||||||0.05|||||||t-test, 2 sided||||
1762222|NCT00127439|3235445|Non-Inferiority or Equivalence|Provided previously||||||0.05|||||||t-test, 2 sided||||
1762223|NCT00127439|3235446|Non-Inferiority or Equivalence|Previously provided||||||0.05|||||||t-test, 2 sided||||
1762224|NCT00127439|3235447|Superiority or Other|||||||0.05|||||||Wilcoxon rank sum test|||Pearson correlation of gait speed changes with directional difference of standardized kinematic scores (i.e. foot trajectory toe-off - degrees, foot trajectory toe-off - % cycle, foot trajectory initial contact - degrees, foot trajectory range - degrees, propulsive impulse N-s, minimum thigh angle - flexion degrees, minimum hip angle - extension degrees, trunk angle mid-stance)|
1762225|NCT00127439|3235447|Non-Inferiority or Equivalence|The power analysis indicated that when the mean difference equals to 1.2 times of standard deviation, a two-sided t-test at 0.05 level will have 80% power; and for a mean difference of 1.4 times of standard deviation the power increases to 91%. To test the null hypothesis that correlation will be 0 at 0.5 level, a two-sided test based on Fisher's Z transformation will yield a power of 89% in detecting correlations of 0.6 or above with n=24 or above.||||||0.05|||||||t-test, 2 sided||||
1762226|NCT00127231|3235453|Equivalence||Odds Ratio (OR)|0.42|||<|0.005|2-Sided|95.0|0.23|0.75|||Mixed Models Analysis|||Drinking frequency was analyzed using a generalized binomial mixed-effects model with the logit link function and a random intercept. The use of a binomial distribution was indicated for this analysis because the outcome was assessed using a 90-day TLFB interview, which has a cap at 90 days.|
1762227|NCT00127205|3235457|Other|||||||0.93|||||||Log Rank|||Statistical analysis for recurrence to bone|
1762228|NCT00127205|3235458|Other|||||||0.5|||||||Log Rank||||
1762229|NCT00127205|3235459|Superiority||Hazard Ratio (HR)|1.06||||0.5|2-Sided|95.0|0.9|1.24|||Regression, Cox||||
1762230|NCT00127205|3235459|Superiority||Hazard Ratio (HR)|1.09||||0.24|2-Sided|95.0|0.94|1.26|||Regression, Cox||||
1762231|NCT00127205|3235459|Other|||||||0.49|||||||Log Rank||||
1762232|NCT00127192|3235460|Superiority or Other||Least-squares Mean Difference|-15.9|||<|0.001||95.0|-22.3|-9.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval||
1762233|NCT00127192|3235460|Superiority or Other||Least-squares Mean Difference|-17.7|||<|0.001||95.0|-24.2|-11.2||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval||
1762234|NCT00127192|3235460|Superiority or Other||Least-squares Mean Difference|-20.8|||<|0.001||95.0|-27.4|-14.3||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval||
1762308|NCT00125619|3235558|Superiority or Other||||||>|0.05|||||||Wilcoxon signed ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.|
1762235|NCT00127192|3235460|Superiority or Other||Least-squares Mean Difference|-23.2|||<|0.001||95.0|-29.8|-16.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval||
1762236|NCT00127192|3235461|Superiority or Other||Least-squares Mean Difference|-0.69|||<|0.001||95.0|-0.85|-0.52||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval||
1762237|NCT00127192|3235461|Superiority or Other||Least-squares Mean Difference|-0.99|||<|0.001||95.0|-1.16|-0.82||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval||
1762238|NCT00127192|3235461|Superiority or Other||Least-squares Mean Difference|-0.96|||<|0.001||95.0|-1.14|-0.79||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval||
1762239|NCT00127192|3235461|Superiority or Other||Least-squares Mean Difference|-1.04|||<|0.001||95.0|-1.21|-0.86||No multiplicity adjustment was done between trend test of primary analysis and pairwise comparisons, but the multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval||
1762240|NCT00127192|3235461|Superiority or Other||||||<|0.001|||||||Tukeys linear trend test based on ANCOVA|Linear contrast including all groups was tested using ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline|||
1762241|NCT00127192|3235462|Superiority or Other||Least-squares Mean Difference|-2.6|||<|0.001||95.0|-3.2|-2.0||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval||
1762242|NCT00127192|3235462|Superiority or Other||Least-squares Mean Difference|-3.3|||<|0.001||95.0|-3.9|-2.7||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval||
1762243|NCT00127192|3235462|Superiority or Other||Least-squares Mean Difference|-3.2|||<|0.001||95.0|-3.9|-2.6||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval||
1762244|NCT00127192|3235462|Superiority or Other||Least-squares Mean Difference|-3.6|||<|0.001||95.0|-4.3|-3.0||Multiplicity among pairwise comparisons of sitagliptin groups against placebo was adjusted by Bonferroni method in post-hoc manner.|Pairwise comparison based on ANCOVA|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used for pairwise comparison|ANCOVA model with terms of treatment, prior antihyperglycemic medication status and baseline was used to estimate difference of two groups and its 95% confidence interval||
1762245|NCT00127166|3235463|Superiority or Other||Least squares mean difference|3.8|||<|0.001||95.0|2.28|5.32|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period.|||
1762246|NCT00127166|3235464|Superiority or Other||Hazard Ratio (HR)|1.26||||0.035||95.0|1.02|1.55|||Cox Proportional Hazards Model|Model terms: treatment and period|Dispersion not applicable to time to event data||
1762247|NCT00127166|3235465|Superiority or Other||Least squares mean difference|4.11|||<|0.001||95.0|2.58|5.64|||ANCOVA|Participant, treatment, period & covariate for FEV1 %-predicted Treatment test is adjusted for period & FEV1 %-predicted at pre-exercise baseline|||
1762248|NCT00127166|3235466|Superiority or Other||Least squares mean difference|-52.71||||0.006||95.0|-89.76|-15.66|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period.|||
1762249|NCT00127166|3235467|Superiority or Other||Least squares mean difference|-3.25||||0.009||95.0|-5.66|-0.84|||ANOVA|Model terms: participant, treatment and period. The treatment test is adjusted for period|||
1762250|NCT00127062|3235470|Superiority||||||>|0.05|||||||t-test, 2 sided||||
1762251|NCT00127062|3235470|Superiority||||||<|0.05|||||||t-test, 2 sided||||
1762309|NCT00125619|3235558|Superiority or Other||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects for manual training.|
1762252|NCT00126776|3235474|Superiority or Other||||||<|0.001|||||||mean cumulative frequency|||primary outcome is mean cumulative frequency of COPD related hospitlaizations and ED visits ;ver 1 yr: 0.48 for disease management; 0.82 for usual care, difference 0.34 (95% CI 0.15 to 0.52; P<0.001)|
1762253|NCT00126737|3235481|Superiority or Other||Mean Difference (Final Values)|18.747||||0.0368|2-Sided|95.0|1.169|36.325|||ANCOVA|Kellgren Lawrence Scale was entered into the model|||
1762254|NCT00126737|3235481|Superiority or Other||Mean Difference (Final Values)|26.71||||0.0024|2-Sided|95.0|9.675|43.746|||ANCOVA|Kellgren Lawrence scale was entered into the model|||
1762255|NCT00126737|3235481|Superiority or Other||Mean Difference (Final Values)|28.129||||0.0018|2-Sided|95.0|10.767|45.492|||ANCOVA|Kellgren Lawrence Scale was entered into the model|||
1762256|NCT00126737|3235482|Superiority or Other||Mean Difference (Final Values)|43.95||||0.0056|2-Sided|95.0|12.54|75.36|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model|||
1762257|NCT00126737|3235482|Superiority or Other||Mean Difference (Final Values)|62.25||||0.0002|2-Sided|95.0|29.97|94.54|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model|||
1762258|NCT00126737|3235482|Superiority or Other||Mean Difference (Final Values)|39.94||||0.0158|2-Sided|95.0|7.655|72.215|||ANCOVA|Total disease (co-morbidity) as covariate was entered into the model|||
1762259|NCT00126737|3235484|Superiority or Other||Mean Difference (Final Values)|4.545||||0.0307|2-Sided|95.0|0.432|8.659|||ANCOVA||||
1762260|NCT00126737|3235485|Superiority or Other||Mean Difference (Final Values)|-5.174||||0.0535|2-Sided|95.0|-10.43|0.079|||ANCOVA|Covariates entered into the model were BMI and WOMAC function|||
1762261|NCT00126737|3235485|Superiority or Other||Mean Difference (Final Values)|-6.395||||0.0129|2-Sided|95.0|-11.41|-1.38|||ANCOVA|Co-variates entered into the model were BMI and WOMAC function subscale.|||
1762262|NCT00126438|3235526|Superiority or Other||Hazard Ratio (HR)|0.35||||0.001|2-Sided|95.0|0.17|0.72||At 0.025 level of significance.|Cox Proportional Hazards Model|||Analysis based on Reader C readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time “t” was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively.|
1762263|NCT00126438|3235526|Superiority or Other||Hazard Ratio (HR)|0.36||||0.001|2-Sided|95.0|0.18|0.72||At 0.025 level of significance.|Cox Proportional Hazards Model|||Analysis based on Reader B readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time “t” was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively.|
1762264|NCT00126438|3235526|Superiority or Other||Hazard Ratio (HR)|0.36||||0.001|2-Sided|95.0|0.18|0.73||At 0.025 level of significance.|Cox Proportional Hazards Model|||Analysis based on Reader A readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time “t” was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively.|
1762265|NCT00126425|3235527|Superiority or Other||Hazard Ratio (HR)|0.44|||=|0|2-Sided|95.0|0.23|0.84||At 0.025 level of significance.|Cox Proportional Hazards Model|||Analysis based on Reader C readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time “t” was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively.|
1762266|NCT00126425|3235527|Superiority or Other||Hazard Ratio (HR)|0.44|||=|0|2-Sided|95.0|0.23|0.84||At 0.025 level of significance.|Cox Proportional Hazards Model|||Analysis based on Reader B readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time “t” was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively.|
1762267|NCT00126425|3235527|Superiority or Other||Hazard Ratio (HR)|0.44|||=|0|2-Sided|95.0|0.23|0.83||At 0.025 level of significance.|Cox Proportional Hazards Model|||Analysis based on Reader A readings. Data analysis to assess the relative hazard of an adverse cardiac event was performed using a Cox proportional hazards model. Hazard (risk) of an event for a participant with low H/M at time “t” was expressed as Hl (t)/ Hh (t) = Ψ, where Hl (t) and Hh (t) denote the hazard of an event at time t for participants with low H/M and high H/M respectively.|
1762268|NCT00126113|3235532|Superiority or Other||||||>|0.05|||||||ANOVA|Analysis for main effect of group|||
1762269|NCT00126113|3235533|Superiority or Other||||||>|0.05|||||||ANOVA|Analysis for main effect of group|||
1762270|NCT00126113|3235534|Superiority or Other||||||>|0.05||||||Analysis for main effect of group|ANOVA||||
1762271|NCT00126113|3235535|Superiority or Other||||||>|0.05|||||||ANOVA|Analysis for main effect of group|||
1762272|NCT00125957|3235536|Superiority or Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference in the median HAM-D score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups|
1762273|NCT00125957|3235537|Superiority or Other|||||||0.04|||||||Wilcoxon (Mann-Whitney)|||Null Hypothesis: There is no difference in the mean change MADRS score between Wellbutrin-Placebo and Placebo-Wellbutrin treatment groups|
1762274|NCT00125931|3235538|Superiority or Other|||||||0.4|||||||t-test, 1 sided|||comparison of mean scores at pre-treatment vs treatment days|
1762275|NCT00125931|3235538|Superiority or Other|||||||0.01|||||||t-test, 1 sided|||comparison of mean score on treatment vs post-treatment days|
1762276|NCT00125931|3235539|Superiority or Other|||||||0.01|||||||ANOVA|||comparison of mean scores at hour 2 vs 3|
1762277|NCT00125853|3235540|Other|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -0.21(0.13)"||||||0.09|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on BMI|
1762513|NCT00119262|3236200|Superiority or Other|||||||0.12|||||||Fisher Exact||||
1762278|NCT00125853|3235541|Other|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE) =0.02 (0.03)"||||||0.48|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on HbA1c|
1762279|NCT00125853|3235542|Other|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -0/09 (0.14)"||||||0.51|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on total cholesterol|
1762280|NCT00125853|3235543|Other|"Linear Mixed effect Model, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE)~= -2.59 (1.34)"||||||0.06|||||||Linear Mixed effect Model, adjusted for|||Comparing treatment effects on ABPM|
1762281|NCT00125853|3235544|Other|"Linear Mixed effect Modelling, adjusted for baseline values and period effect~Difference of LSMeans treatment effect (SE) = 0.05 (0.09)"||||||0.6|||||||Linear Mixed effect Modelling, adjusted|||Comparing treatment effects on ISI|
1762282|NCT00125658|3235547|Superiority or Other|||||||0.635|||||||t-test, 2 sided|||Tests for the effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in movement smoothness between the end of overall treatment (20 weeks) and baseline.|
1762283|NCT00125658|3235547|Superiority or Other|||||||0.085|||||||t-test, 2 sided|||Tests for the effect of treatment (FTP vs. POWER) by comparing the change in movement smoothness between the end of treatment block 1 (10 weeks) and baseline.|
1762284|NCT00125658|3235548|Superiority or Other|||||||0.4|||||||t-test, 2 sided|||Tests the effect of treatment order (Order A (FTP > POWER) vs. Order B (POWER > FTP)) by comparing the change in RPR between the end of overall treatment (20 weeks) and baseline.|
1762285|NCT00125658|3235548|Superiority or Other|||||||0.078|||||||t-test, 2 sided|||Tests for differences in FTP vs. POWER by comparing the change in RPR between the end of treatment block 1 (10 weeks) and baseline.|
1762286|NCT00125658|3235549|Superiority or Other|||||||0.948|||||||Wilcoxon (Mann-Whitney)|||Tests for an effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in UE FMA between the end of treatment (20 weeks) and baseline.|
1762287|NCT00125658|3235549|Superiority or Other|||||||0.564|||||||Wilcoxon (Mann-Whitney)|||Tests the effects of FTP vs. POWER on motor impairment (UE FMA) by comparing the change in FMA between the end of treatment block 1 (10 weeks) and baseline.|
1762288|NCT00125658|3235550|Superiority or Other|||||||0.168|||||||t-test, 2 sided|||Tests for effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP))by comparing the change in movement speed between the end of overall treatment (20 weeks) and baseline.|
1762289|NCT00125658|3235550|Superiority or Other|||||||0.056|||||||t-test, 2 sided|||Tests for differences between FTP vs. POWER by comparing the change in movement speed between the end of treatment block 1 (10 weeks) and baseline.|
1762290|NCT00125658|3235551|Superiority or Other|||||||0.034|||||||t-test, 2 sided|||Tests for the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP) by comparing the change in elbow extension range of motion between the end of overall treatment (20 weeks) and baseline.|
1762291|NCT00125658|3235551|Superiority or Other|||||||0.004|||||||t-test, 2 sided|||Compares FTP vs POWER by comparing the change in elbow extension range of motion between the end of treatment block 1 (10 weeks) and baseline.|
1762292|NCT00125658|3235552|Superiority or Other|||||||0.048|||||||t-test, 2 sided|||Test the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP). The change in shoulder flexion range of motion was compared between the end of treatment (20 weeks) and baseline.|
1762293|NCT00125658|3235552|Superiority or Other|||||||0.13|||||||t-test, 2 sided|||Tests effect of FTP vs. Power. The change in shoulder flexion range of motion was compared between baseline and the end of treatment Block 1 (i.e., 10 weeks).|
1762294|NCT00125658|3235553|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||Order effect, testing OrderA (FTP before POWER) vs. OrderB (POWER before FTP). Change scores for trunk displacement at the end of both treatment blocks (20 weeks) relative to baseline (e.g., 20 weeks - baseline) were compared between OrderA and OrderB.|
1762295|NCT00125658|3235553|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|||Primary Comparison (i.e., FTP vs. POWER) Data are reported as change scores, between the end of treatment block 1(10 weeks) and baseline; thus, this analysis directly compares FTP vs. Power. A negative value represents improvement (i.e., reduced trunk displacement) while a positive value represents an increase in compensatory trunk movement.|
1762296|NCT00125619|3235554|Superiority or Other||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.|
1762297|NCT00125619|3235554|Superiority or Other||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of manual training.|
1762298|NCT00125619|3235554|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.|
1762299|NCT00125619|3235555|Superiority or Other||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-treatment effects of robot training.|
1762300|NCT00125619|3235555|Superiority or Other||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of manual training.|
1762301|NCT00125619|3235555|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.|
1762302|NCT00125619|3235556|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Within group comparison for pre- vs. post-training effects of robot training.|
1762303|NCT00125619|3235556|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Within groups comparison for pre- vs. post-training effects of manual training.|
1762304|NCT00125619|3235556|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of robot vs. manual training.|
1762305|NCT00125619|3235557|Superiority or Other||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group comparison of pre- vs. post-training effects of robot training.|
1762306|NCT00125619|3235557|Superiority or Other||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within groups comparison of pre- vs. post-treatment effects of manual training.|
1762307|NCT00125619|3235557|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between groups comparison of effects of robot vs. manual training.|
1764482|NCT00095498|3239347|Superiority or Other||||||<|0.016|||||||van Elteren Stratified Rank Test||||
1762310|NCT00125619|3235558|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between-groups comparison of robot vs. manual training.|
1762311|NCT00125619|3235559|Superiority or Other||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within-groups comparison of pre- vs. post-treatment effects for Robot (Lokomat) training.|
1762312|NCT00125619|3235559|Superiority or Other||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within groups comparison (pre- vs. post-treatment) due to Manual (therapist-assisted) treatment.|
1762313|NCT00125619|3235559|Superiority or Other||||||>|0.05|||||||Wilcoxon (Mann-Whitney)|||Between-groups comparison of Robot vs. Manual training.|
1762314|NCT00125619|3235560|Superiority or Other||||||>|0.05|||||||Wilcoxon Signed Ranks|||Within group test for change pre- vs. post-training due to Manual (Therapist Assisted) training.|
1762315|NCT00125619|3235560|Superiority or Other||||||<|0.05|||||||Wilcoxon Signed Ranks|||Within group test for change pre- vs. post-training due to Robot (Lokomat) training.|
1762316|NCT00125619|3235560|Superiority or Other||||||<|0.72|||||||Wilcoxon (Mann-Whitney)|||Between group comparison of Robot (Lokomat) vs. Manual (therapist-assisted) training.|
1762317|NCT00125593|3235561|Superiority or Other||Risk Ratio (RR)|0.97||||0.41|2-Sided|95.0|0.89|1.05|||Log Rank|||All analyses by intention to treat|
1762318|NCT00125593|3235562|Superiority or Other||Risk Ratio (RR)|0.79||||0.0036|2-Sided|95.0|0.68|0.93|||Log Rank|||All analyses by intention to treat|
1762319|NCT00125593|3235563|Superiority or Other||Risk Ratio (RR)|0.75||||0.01|2-Sided|95.0|0.6|0.94|||Log Rank|||All analyses by intention to treat|
1762320|NCT00125593|3235564|Superiority or Other||Risk Ratio (RR)|0.92||||0.37|2-Sided|95.0|0.76|1.11|||Log Rank|||All analyses by intention to treat|
1762321|NCT00125593|3235565|Superiority or Other||Risk Ratio (RR)|0.84||||0.001|2-Sided|95.0|0.75|0.93|||Log Rank|||All analyses by intention to treat|
1762322|NCT00125593|3235566|Superiority or Other||Risk Ratio (RR)|0.85||||0.0012|2-Sided|95.0|0.77|0.94|||Log Rank|||All analyses by intention to treat|
1762323|NCT00125593|3235567|Superiority or Other||Risk Ratio (RR)|0.83||||0.0021|2-Sided|95.0|0.74|0.94|||Log Rank|||All analyses by intention to treat|
1762324|NCT00125515|3235570|Superiority or Other|||||||0.32|||||||Chi-squared|||all statistical analysis were two tailed and employed an alpha significance level of 0.05.|
1762325|NCT00125242|3235583|Superiority or Other||effect size|7.15|Standard Deviation|3.1|||2-Sided||||||||the reported effect size is a d-index value|Effect sizes were calculated - this is a comparison of perfomance in baseline (repeated measurements prior to treatment) relative to peformance following treatment|
1762326|NCT00125164|3235596|Superiority or Other (legacy)||LS mean difference|0.15|Standard Error of the Mean|0.06||0.0071||95.0|0.04|0.26|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.|
1762327|NCT00125164|3235596|Superiority or Other (legacy)||LS mean difference|0.52|Standard Error of the Mean|0.06|<|0.0001||95.0|0.39|0.64||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett’s method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.|
1762328|NCT00125164|3235596|Superiority or Other (legacy)||LS mean difference|0.37|Standard Error of the Mean|0.06|<|0.0001||95.0|0.25|0.5||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett’s method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.|
1762329|NCT00125164|3235597|Superiority or Other (legacy)||LS mean difference|1.01|Standard Error of the Mean|0.25||0.0002||95.0|0.5|1.51|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.|
1762330|NCT00125164|3235597|Superiority or Other (legacy)||LS mean difference|2.83|Standard Error of the Mean|0.29|<|0.0001||95.0|2.26|3.39||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett’s method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.|
1762331|NCT00125164|3235597|Superiority or Other (legacy)||LS mean difference|1.83|Standard Error of the Mean|0.29|<|0.0001||95.0|1.26|2.4||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett’s method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.|
1762332|NCT00125164|3235605|Superiority or Other (legacy)||LS mean difference|0.11|Standard Error of the Mean|0.05||0.0495||95.0|0.0|0.22|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.|
1762333|NCT00125164|3235605|Superiority or Other (legacy)||LS mean difference|0.47|Standard Error of the Mean|0.06|<|0.0001||95.0|0.34|0.6||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett’s method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.|
1762351|NCT00124943|3235678|Superiority or Other|||||||0.317|||||||ANOVA|P-value testing dose group differences based on an analysis of variance with dose effect in the model.|||
1763143|NCT00113529|3236960|Superiority or Other|||||||0.883|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1762334|NCT00125164|3235605|Superiority or Other (legacy)||LS mean difference|0.37|Standard Error of the Mean|0.07|<|0.0001||95.0|0.24|0.5||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett’s method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.|
1762335|NCT00125164|3235606|Superiority or Other (legacy)||LS mean difference|0.79|Standard Error of the Mean|0.26||0.0032||95.0|0.27|1.31|||ANCOVA|||The analysis compares the 80 and 120 µg/kg BID groups using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.|
1762336|NCT00125164|3235606|Superiority or Other (legacy)||LS mean difference|2.58|Standard Error of the Mean|0.3|<|0.0001||95.0|1.99|3.16||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett’s method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.|
1762337|NCT00125164|3235606|Superiority or Other (legacy)||LS mean difference|1.79|Standard Error of the Mean|0.3|<|0.0001||95.0|1.19|2.39||The two-sided p-values for the comparisons are adjusted for multiple comparisons using Dunnett’s method.|ANCOVA|||The analysis compares each of the 80 and 120 µg/kg BID groups with the untreated control group using analysis of covariance (ANCOVA), where the covariates are the baseline height SD score stratum used in the randomization, the pretreatment height velocity, the baseline bone age, the baseline chronological age, and sex.|
1762338|NCT00125138|3235607|Superiority or Other|||||||0.9212||||||Overall p-value using a one-way ANCOVA.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||Only subjects with both a baseline and a post-baseline value are included.|
1762339|NCT00125138|3235608|Superiority or Other||Difference of LS mean|0.3||||0.5406|2-Sided|95.0|-5.2|5.8||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.|
1762340|NCT00125138|3235608|Superiority or Other||Difference of LS mean|-2.9||||0.1519|2-Sided|95.0|-8.5|2.7||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate.||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.|
1762341|NCT00125138|3235608|Superiority or Other||Difference of LS Mean|0.1||||0.5177|2-Sided|95.0|-6.3|6.6||One-sided pairwise p-value comparing each active treatment to placebo.|ANCOVA|One-way ANCOVA: Treatment, country, and baseline anti-psychotic medication status (recent or distant) as factors; baseline measurement as a covariate||The null hypothesis for each endpoint is that each melperone dose has the same mean as placebo; the alternative hypothesis is that at least one dose is more efficacious than placebo. Only subjects with both a baseline and Day 43 (end of Maintenance Phase) value are included.|
1762342|NCT00125034|3235613|Superiority or Other||Hazard Ratio (HR)|1.29||||0.2004|2-Sided|95.0|0.873|1.906|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|||
1762343|NCT00125034|3235614|Superiority or Other||Hazard Ratio (HR)|0.855||||0.3854|2-Sided|95.0|0.599|1.219|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|||
1762344|NCT00125034|3235615|Superiority or Other||Hazard Ratio (HR)|1.015||||0.905|2-Sided|95.0|0.791|1.303|||Stratified log rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|||
1762345|NCT00125034|3235616|Superiority or Other||Hazard Ratio (HR)|1.72||||0.0153|2-Sided|95.0|1.104|2.679|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|||
1762346|NCT00125034|3235617|Superiority or Other||Hazard Ratio (HR)|0.567||||0.0064|2-Sided|95.0|0.375|0.856|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|||
1762347|NCT00125034|3235618|Superiority or Other||Hazard Ratio (HR)|0.931||||0.617|2-Sided|95.0|0.705|1.23|||Stratified Log Rank|Kaplan-Meier method used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.|||
1762348|NCT00125034|3235619|Superiority or Other||Odds Ratio (OR)|0.459||||0.029|2-Sided|95.0|0.228|0.924|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.|||
1762349|NCT00125034|3235620|Superiority or Other||Odds Ratio (OR)|2.551||||0.0027|2-Sided|95.0|1.38|4.717|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.|||
1762350|NCT00125034|3235621|Superiority or Other||Odds Ratio (OR)|1.516||||0.064|2-Sided|95.0|0.975|2.335|||stratified Cochran-Mantel-Haenszel test|Stratified odds ratio and Cochran-Mantel-Haenszel (CMH) statistics were calculated considering the randomization strata.||Assuming a difference in rate of best confirmed response of at least 20% between the 2 treatments, ie an approximately 70% response rate under cetuximab plus FOLFOX-4 & 50% under FOLFOX-4 alone for the stratum with ECOG PS0–1 & 66% and 45% respectively for the ECOG PS2 stratum, the common OddsR over the strata was expected to be 2.33. A sample size of approximately 146/group was calculated as necessary to detect a significant overall response of at least 2.33 at level α=0.05 with a power of 90%|
1762352|NCT00124943|3235679|Superiority or Other|||||||0.495|||||||Fisher Exact|||Comparison of in-segment late lumen loss. The statistical testing of treatment difference is for exploratory purposes.|
1762353|NCT00124943|3235679|Superiority or Other|||||||0.709|||||||Fisher Exact|||Comparison of in-stent late lumen loss. The statistical testing of treatment difference is for exploratory purposes.|
1762354|NCT00124943|3235680|Superiority or Other|||||||0.061|||||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.|
1762355|NCT00124943|3235681|Superiority or Other||||||>|0.999|||||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.|
1762356|NCT00124943|3235682|Superiority or Other|||||||0.4|||||||Fisher Exact|||Comparison of in-segment binary restenosis. The statistical testing of treatment difference is for exploratory purposes|
1762357|NCT00124943|3235682|Superiority or Other|||||||0.293|||||||Fisher Exact|||Comparison of in-stent binary restenosis. The statistical testing of treatment difference is for exploratory purposes.|
1762358|NCT00124943|3235683|Superiority or Other|||||||0.783|||||||Fisher Exact|||Comparison of the number of patients with any treatment emergent adverse event. The statistical testing of treatment difference is for exploratory purposes.|
1762359|NCT00124943|3235684|Superiority or Other|||||||0.396|||||||Fisher Exact|||The statistical testing of treatment difference is for exploratory purposes.|
1762360|NCT00124709|3235720|Superiority or Other||Mean Difference (Final Values)|0.0046||||0.7901|2-Sided|95.0|-0.029|0.0381|||ANCOVA|Treatment, Center, gender, baseline age (months), baseline EASI score, and baseline TBSA as explanatory variables||"A disease-free day in Step 2 or less was defined as a diary day with variable No or almost no eczema?=yes and medication used variable=no except emollients, yellow label medication 2X day, or medication deviation of yellow label medication 1x day."|
1762361|NCT00124657|3235726|Superiority or Other||Kaplan-Meier|0.19|Standard Deviation|0.077|||2-Sided|95.0|0.039|0.341||||||2-year progression free survival (n=21)|
1762362|NCT00124657|3235726|Superiority or Other||Kaplan-Meier|0.19|Standard Deviation|0.077|||2-Sided|95.0|0.039|0.341||||||1-year progression free survival (n=21)|
1762363|NCT00124657|3235726|Superiority or Other||Kaplan-Meier|0.15|Standard Deviation|0.069|||2-Sided|95.0|0.015|0.285||||||2-year progression free survival (n=20)|
1762364|NCT00124657|3235726|Superiority or Other||Kaplan-Meier|0.45|Standard Deviation|0.106|||2-Sided|95.0|0.198|0.602||||||1-year progression free survival (n=20)|
1762365|NCT00124657|3235726|Superiority or Other||Kaplan-Meier|0.33|Standard Error of the Mean|0.12|||2-Sided|95.0|0.09|0.57||||||1-year progression-free survival (n=12)|
1762366|NCT00124657|3235726|Superiority or Other||Kaplan-Meier|0.75|Standard Error of the Mean|0.14|||2-Sided|95.0|0.48|1.0||||||1-year progression-free survival (n=8)|
1762367|NCT00124020|3235768|Non-Inferiority or Equivalence|Non-inferiority margin of 20% was specified based on historical regulatory precedent.|Risk Difference (RD)|0.2||||||95.0|-6.8|7.2|||||||
1762368|NCT00123630|3235785|Superiority or Other||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1762369|NCT00123487|3235804|Non-Inferiority or Equivalence|Non-inferiority of the QD schedule relative to the BID schedule was claimed if the lower bound of the 95% CI for difference (QD - BD) was ≥ -12%.|Percent Difference|0.2|||||2-Sided|95.0|-7.8|8.1||||||Primary endpoint was to be assessed at 6-Months: Assuming a 45% MaHR rate in the 70 mg BID participants, the primary efficacy analysis required a total of 540 participants, approximately 270 in each dosing schedule, giving at least 80% power to deduce non-inferiority of the QD schedule relative to the BID schedule if the lower bound of the 95% CI for the difference in MaHR rates (MaHRRQD - MaHRRBID) is greater than -12%.|
1762370|NCT00123474|3235814|Non-Inferiority or Equivalence|Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.|Risk Difference (RD)|1.4|||||2-Sided|95.0|-11.2|14.1||||||24 Month Analysis|
1762371|NCT00123474|3235814|Non-Inferiority or Equivalence|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.4|||||2-Sided|95.0|-11.2|14.1||||||24 Month Analysis|
1762372|NCT00123474|3235814|Non-Inferiority or Equivalence|Non-inferiority of 100 mg QD Total Daily Dose relative to 140 mg QD Total Daily Dose was deduced if the lower bound of the 95% CI difference was greater than or equal to -15%.|Risk Difference (RD)|4.2|||||2-Sided|95.0|-9.3|17.6||||||6 Month Analysis|
1762373|NCT00123474|3235814|Non-Inferiority or Equivalence|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.8|||||2-Sided|95.0|-11.7|15.3||||||6 Month Analysis|
1762374|NCT00123474|3235825|Non-Inferiority or Equivalence|Non-inferiority of 100 mg total daily dose relative to 140 mg total daily dose was deduced if the lower bound of the 95% CI for the difference was greater than or equal to -15%.|Risk Difference (RD)|-0.2|||||2-Sided|95.0|-8.9|8.5|||||||
1762375|NCT00123474|3235825|Non-Inferiority or Equivalence|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% CI for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|1.9|||||2-Sided|95.0|-6.8|10.6|||||||
1762376|NCT00123474|3235826|Non-Inferiority or Equivalence|Non-inferiority of the QD schedule relative to the BID schedule was deduced if the lower bound of the 95% confidence interval (CI) for the MCyRRQD minus MCyRRBID difference was greater than or equal to -15%.|Risk Difference (RD)|2.8|||||2-Sided|95.0|-6.0|11.6||||||6 Month Analysis|
1762377|NCT00123422|3235827|Superiority or Other||||||<|0.05|||||||ANCOVA|The baseline value was the co-variate in this analysis.|||
1762378|NCT00123422|3235828|Superiority or Other|||||||0.015||||||Statistical tests were 2-sided and a p value of < 0.05 was the criterion for statistical significance.|ANCOVA|The baseline value was the co-variate in this analysis.|||
1762379|NCT00123162|3235831|Superiority or Other||Mean Difference (Net)|-42.6|||<|0.001|2-Sided|95.0|-58.3|-26.8|||Mixed Models Analysis||Comparison of the VAS score at hour 4 (Sildenafil Citrate - Placebo)||
1762410|NCT00122460|3235895|Superiority or Other||Odds Ratio (OR)|2.326||||0.0001|2-Sided|95.0|1.504|3.6|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.|
1762380|NCT00123162|3235832|Superiority or Other||Mean Difference (Net)|5.3|||<|0.001|2-Sided|95.0|2.9|7.6|||ANCOVA|adjusted for baseline pain intensity (Visual Analog Scale (VAS) score).||With 26 subjects per treatment group and an assumed within-group standard deviation of 7 units, the study was designed to have 90% statistical power for a two-sided, 0.05 significance level test to detect a difference of 6.5 units in TOPAR4 between a single dose of 100 mg of sildenafil and placebo. However, we anticipated subject drop-out as high as 15%; therefore, we planned to recruit 31 subjects per treatment group.|
1762381|NCT00123123|3235834|Superiority or Other|||||||0.675|||||||ANOVA|||A mixed effect model was used to compare overall treatment effects between groups for repeated measures data. The group comparison for each time point was performed using ANOVA.|
1762382|NCT00122980|3235844|Superiority or Other||||||<|0.01|||||||ANCOVA|Controlling for baseline value and time on study|||
1762383|NCT00122980|3235845|Superiority or Other|||||||0.033|||||||ANCOVA|Analysis controlling for baseline value and time on study.|||
1762384|NCT00122980|3235846|Superiority or Other|||||||0.039|||||||ANOVA|||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.|
1762385|NCT00122980|3235847|Superiority or Other||||||>|0.05|||||||ANOVA|||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.|
1762386|NCT00122980|3235848|Superiority or Other|||||||0.841|||||||ANOVA|||The change-from-baseline to endpoint scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.|
1762387|NCT00122980|3235849|Superiority or Other||||||>|0.05|||||||ANOVA|The change-from-baseline scores for each scale were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.|
1762388|NCT00122980|3235850|Superiority or Other||||||>|0.05|||||||ANOVA|The change-from-baseline scores for each scale were analyzed with an analysis of variance model (ANOVA) with treatment as stratum.||The change-from-baseline scores were analyzed with an analysis of variance model (ANOVA) with treatment as stratum, testing the hypothesis that the average change from baseline scores do not differ between the treatment groups.|
1762389|NCT00122980|3235851|Superiority or Other|||||||0.144||||||The a priori defined LOCF approach was deemed to be biased due to the study's early termination, and was replaced by this mixed models analysis.|Mixed Models Analysis|Including main effects of age at consent, baseline iron, and treatment group, on observed change from baseline Log10 transformed values only.||Concluding that Hydroxyurea/Phlebotomy group is better than the Transfusion/Chelation group required rejecting the STROKE null hypothesis (see previous primary endpoint analysis) in favor of the alternative: Hydroxyurea/Phlebotomy recurrent stroke rate is less than Transfusion/Chelation rate plus 0.20 AND rejecting the IRON null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy baseline-adjusted mean log10 transformed LIC is less than for Transfusion/Chelation.|
1762390|NCT00122980|3235852|Non-Inferiority or Equivalence|Based on pilot data, the efficacy of hydroxyurea to reduce secondary stroke rate was not predicted to be equivalent to transfusions. Therefore, an increased stroke rate (non-inferiority margin = 0.20) was allowed by study design. This “acceptable” stroke margin was predicted to be offset by the likelihood of significantly greater improvement in the management of iron overload through elimination of transfusions along with serial phlebotomy in the Hydroxyurea/Phlebotomy arm.||||||0.214|||||||Log Rank|||Concluding that Hydroxyurea/Phlebotomy group is better than the Transfusion/Chelation group required rejecting the STROKE null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy recurrent stroke rate is less than Transfusion/Chelation rate plus 0.20, the non-inferiority margin, AND rejecting the IRON null hypothesis in favor of the alternative: Hydroxyurea/Phlebotomy baseline-adjusted mean LIC is less than for Transfusion/Chelation (see next primary endpoint analysis).|
1762391|NCT00122681|3235856|Superiority or Other||Hazard Ratio (HR)|0.635||||0.2111|2-Sided|95.0|0.312|1.293|||Chi-squared|||Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.|
1762392|NCT00122681|3235858|Superiority or Other||Hazard Ratio (HR)|0.61||||0.1035||95.0|0.337|1.106|||Chi-squared|||Hazard ratio of anti-HPV-18 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection.|
1762393|NCT00122681|3235860|Superiority or Other||Hazard Ratio (HR)|0.778||||0.3796|2-Sided|95.0|0.444|1.362|||Chi-squared|||Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 12-month persistent infection compared to subjects with 12-month persistent infection.|
1762394|NCT00122681|3235862|Superiority or Other||Hazard Ratio (HR)|0.798||||0.391|2-Sided|95.0|0.476|1.337|||Chi-squared|||Hazard ratio of anti-HPV-16 GMTs at Month 7 (by ELISA) in subjects without 6-month persistent infection compared to subjects with 6-month persistent infection|
1762395|NCT00122681|3235887|Superiority or Other||1-Rate Ratio|87.6|||||2-Sided|95.0|59.2|97.6||||||Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).|
1762396|NCT00122681|3235887|Superiority or Other||1-Rate Ratio|95.7|||||2-Sided|95.0|88.5|98.9||||||Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).|
1762411|NCT00122460|3235896|Superiority or Other||Hazard Ratio (HR)|0.538|||<|0.0001|2-Sided|95.0|0.431|0.672|||Stratified Log Rank|||"To test the equality of PFS between treatment groups, a two-sided stratified log-rank test (α=5%)was used, taking into account strata used for randomization (previous CTX [yes/no] and KPS [<80 vs. ≥80]).~Median PFS time was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."|
1762397|NCT00122681|3235887|Superiority or Other||1-Rate Ratio|93.6|||||2-Sided|95.0|86.3|97.5||||||Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).|
1762398|NCT00122681|3235887|Superiority or Other||1-Rate Ratio|87.1|||||2-Sided|95.0|57.2|97.5||||||Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.|
1762399|NCT00122681|3235887|Superiority or Other||1-Rate Ratio|97.6|||||2-Sided|95.0|91.0|99.7||||||Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed|
1762400|NCT00122681|3235887|Superiority or Other||1-Rate Ratio|94.9|||||2-Sided|95.0|87.7|98.4||||||Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed|
1762401|NCT00122681|3235888|Superiority or Other||1-Rate Ratio|87.6|||||2-Sided|95.0|44.1|98.8||||||Vaccine efficacy against CIN2+ for HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).|
1762402|NCT00122681|3235888|Superiority or Other||1-Rate Ratio|92.7|||||2-Sided|95.0|79.3|98.2||||||Vaccine efficacy against CIN2+ for HPV-16 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).|
1762403|NCT00122681|3235888|Superiority or Other||1-Rate Ratio|90.8|||||2-Sided|95.0|78.1|96.9||||||Vaccine efficacy against CIN2+ for HPV-16 or HPV-18 (by PCR) in HPV DNA negative subjects at baseline, regardless of initial serostatus, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event).|
1762404|NCT00122681|3235888|Superiority or Other||1-Rate Ratio|86.7|||||2-Sided|95.0|39.7|98.7||||||Vaccine efficacy against CIN2+ associated with HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.|
1762405|NCT00122681|3235888|Superiority or Other||1-Rate Ratio|95.7|||||2-Sided|95.0|82.9|99.6||||||Vaccine efficacy against CIN2+ associated with HPV-16 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.|
1762406|NCT00122681|3235888|Superiority or Other||1-Rate Ratio|92.9|||||2-Sided|95.0|79.9|98.3||||||Vaccine efficacy against CIN2+ associated with HPV-16 or HPV-18 (by PCR) in HPV DNA negative and seronegative subjects at baseline, using conditional exact method. The VE was defined as follows: VE = 1-Rate Ratio (RR), where RR = incidence rate in HPV Group (vaccine)/ incidence rate in HAV Group (control); Incidence rate = n/T(per 100); n= number of subjects reporting at least one event in each group and T(years) = sum of follow-up period (censored at the first occurrence of an event) expressed.|
1762407|NCT00122460|3235892|Superiority or Other||Hazard Ratio (HR)|0.762||||0.21|2-Sided|95.0|0.497|1.168|||Stratified Log Rank|||"To test the equality of duration of response between treatment groups, the two-sided stratified log-rank test (α=5%) was used taking strata used for randomization into account (previous CTX [no vs. yes] and KPS [<80 vs. ≥80]).~Median duration of response was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."|
1762408|NCT00122460|3235893|Superiority or Other||Hazard Ratio (HR)|0.593|||<|0.0001|2-Sided|95.0|0.484|0.727|||Stratified Log Rank|||"Treatment groups were compared applying a two-sided stratified log-rank test (α=5%), taking into account strata used for randomization (previous CTX [yes/no] and KPS [<80 vs. ≥80]).~Median time to treatment failure was estimated using the Kaplan-Meier method. The HR of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."|
1762409|NCT00122460|3235894|Superiority or Other||Odds Ratio (OR)|2.881|||<|0.0001|2-Sided|95.0|1.87|4.441|||Cochran-Mantel-Haenszel|||A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.|
1762440|NCT00122369|3235940|Superiority or Other||||||<|0.45|||||||Ordinal regression||||
1762441|NCT00122369|3235940|Superiority or Other||||||<|0.001|||||||Ordinal regression||||
1762412|NCT00122460|3235897|Superiority or Other||Hazard Ratio (HR)|0.797||||0.036|2-Sided|95.0|0.644|0.986|||Stratified Log Rank|||"The primary analysis tested the equality of OS between treatment groups applying a 2-sided stratified log-rank test (α=5%), taking into account the strata used for randomization (previous chemotherapy (CTX) [no vs. yes] and Karnofsky Performance Status (KPS) [<80 vs. ≥80]).~Median overall survival was estimated using the Kaplan-Meier method. The Hazard Ratio (HR) of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata."|
1762413|NCT00122447|3235899|Superiority or Other||Slope|0.012|Standard Error of the Mean|0.012||0.313|2-Sided|95.0|-0.012|0.037||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear||||
1762414|NCT00122447|3235899|Superiority or Other||Slope|0.014|Standard Error of the Mean|0.013||0.28|2-Sided|95.0|-0.012|0.039||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear||||
1762415|NCT00122447|3235899|Superiority or Other||Slope|-0.001|Standard Error of the Mean|0.012||0.943|2-Sided|95.0|-0.025|0.023||Association between treatment arm, compared to placebo, on change in FMD from baseline to 12 months of intervention, adjusted for age, sex, race, and LDL-cholesterol.|Regression, Linear|||Null hypothesis: no difference between active treatment group compared to placebo.|
1762416|NCT00122447|3235900|Superiority or Other||Slope|0.088|Standard Error of the Mean|1.21||0.943|2-Sided|95.0|-2.367|2.542||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear||||
1762417|NCT00122447|3235900|Superiority or Other||Slope|-2.677|Standard Error of the Mean|1.211||0.034|2-Sided|95.0|-5.133|-0.221||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear||||
1762418|NCT00122447|3235900|Superiority or Other||Slope|-0.941|Standard Error of the Mean|1.229||0.449|2-Sided|95.0|-3.435|1.552||Association between treatment arm, compared to placebo, on change in hsCRP from baseline to 12 months of intervention, adjusted for age, sex, and race.|Regression, Linear||||
1762419|NCT00122382|3235903|Superiority or Other||||||<|0.001|||||||signed rank test||||
1762420|NCT00122382|3235918|Superiority or Other||||||<|0.04||||||Total score was tested only if there was statistical significance in remission rate. For each test, the nominal type I error rate is set at 5%; this sequential testing procedure preserves the overall type I error rate at 5%.|non-parametric ANCOVA||||
1762421|NCT00122382|3235919|Superiority or Other||Estimated Difference between ABA and PLA|18.1|||<|0.001|2-Sided|95.0|9.6|26.6||Total score was tested only if there was statistical significance in remission rate. For each test, the nominal type I error rate is set at 5%; this sequential testing procedure preserves the overall type I error rate at 5%.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving DAS28-CRP remission.|
1762422|NCT00122382|3235921|Superiority or Other|||||||0.353||||||P-value of <0.05: probability for comparison of change in radiographic scores between abatacept and placebo.|Nonparametric ANCOVA|||comparison of change in JSN scores between abatacept and placebo|
1762423|NCT00122382|3235921|Superiority or Other|||||||0.033||||||P-value of <0.05: probability for comparison of change in radiographic scores between abatacept and placebo.|Nonparametric ANCOVA|||comparison of change in erosion scores between abatacept and placebo|
1762424|NCT00122382|3235922|Superiority or Other||Estimate of/Adjusted Difference|1.81||||0.046|2-Sided|95.0|0.03|3.6||p-value of <0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||MCS Adjusted Mean Change from Baseline to Month 12|
1762425|NCT00122382|3235922|Superiority or Other||Estimate of/Adjusted Difference|2.5||||0.005|2-Sided|95.0|0.77|4.23||p-value of <0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.||PCS Adjusted Mean Change from Baseline to Month 12|
1762426|NCT00122382|3235923|Superiority or Other||Estimated Difference between ABA and PLA|9.8||||0.024|2-Sided|95.0|1.3|18.4||p-value of <0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving HAQ response.|
1762427|NCT00122382|3235924|Superiority or Other||Estimate of/Adjusted Difference|-0.73|||<|0.001|2-Sided|95.0|-0.98|-0.48||p-value of <0.05: probability for testing the difference between ABA and PLA.|ANCOVA|Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|||
1762428|NCT00122382|3235925|Superiority or Other||Estimated Difference between ABA and PLA|15.5|||<|0.001|2-Sided|95.0|8.2|22.8||p-value of <0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving MCR.|
1762429|NCT00122382|3235926|Superiority or Other||Estimated Difference between ABA and PLA|15.1|||<|0.001|2-Sided|95.0|6.0|24.2||p-value of <0.05: probability for testing the difference between ABA and PLA.|Chi-squared, Continuity-Corrected|||Estimated Difference between ABA and PLA is the estimated difference between ABA and PLA in the proportion of subjects achieving an ACR 50 response.|
1762430|NCT00122369|3235927|Superiority or Other|||||||0.73|||||||Proportional odds model||||
1762431|NCT00122369|3235927|Superiority or Other|||||||0.018|||||||Proportional odds model||||
1762432|NCT00122369|3235927|Superiority or Other|||||||0.024|||||||Proportional odds model||||
1762433|NCT00122369|3235927|Superiority or Other||||||<|0.001|||||||Ordinal regression||||
1762434|NCT00122369|3235927|Superiority or Other||||||<|0.001|||||||Ordinal regression||||
1762435|NCT00122369|3235927|Superiority or Other||||||<|0.001|||||||Ordinal regression||||
1762436|NCT00122369|3235940|Superiority or Other||||||<|0.01|||||||Proportional odds model||||
1762437|NCT00122369|3235940|Superiority or Other||||||<|0.001|||||||Proportional odds model||||
1762438|NCT00122369|3235940|Superiority or Other||||||<|0.01|||||||Proportional odds model||||
1762439|NCT00122369|3235940|Superiority or Other||||||<|0.001|||||||Ordinal regression||||
1762442|NCT00122369|3235952|Superiority or Other|||||||0.56|||||||ANOVA|||The null-hypothesis was that there would be no difference among groups.|
1762443|NCT00122369|3235953|Superiority or Other|||||||0.138||||||Bonferoni correction was made so that results with p<0.0167 are considered significant.|t-test, 2 sided||||
1762444|NCT00122369|3235953|Superiority or Other|||||||0.421||||||Bonferoni correction was made so that results with p<0.0167 are considered significant.|t-test, 2 sided||||
1762445|NCT00122369|3235953|Superiority or Other|||||||0.014||||||Bonferoni correction was made so that results with p<0.0167 are considered significant|t-test, 2 sided|||The impact of knowing or not knowing the diagnosis became so overwhelming and group composition with regard of whether and which result had been communicated changed daily in the post-biopsy follow-up, so that the originally planned analysis of the impact of Self-Hynotic Relaxation or Empathic Attention on cortisol measures became underpowered. Therefore we focused on the analysis of the impact of diagnosis.|
1762446|NCT00122135|3235963|Superiority or Other|||||||0.77|||||||t-test, 2 sided||||
1762447|NCT00121810|3235978|Superiority or Other||Mean Difference (Net)|7.5||||0.036||95.0|0.5|14.5||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months|
1762448|NCT00121810|3235978|Superiority or Other||Mean Difference (Net)|5.8||||0.059||95.0|-0.2|11.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months|
1762449|NCT00121810|3235978|Superiority or Other||Mean Difference (Net)|8.5|||<|0.001||95.0|4.2|12.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months|
1762450|NCT00121810|3235979|Superiority or Other||Mean Difference (Net)|8.8||||0.015||95.0|1.7|15.9||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months|
1762451|NCT00121810|3235979|Superiority or Other||Mean Difference (Net)|6.9||||0.029||95.0|0.7|13.1||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months|
1762452|NCT00121810|3235979|Superiority or Other||Mean Difference (Net)|8.7|||<|0.001||95.0|4.1|13.3||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months|
1762453|NCT00121810|3235980|Superiority or Other||Mean Difference (Net)|-24.4||||0.039||95.0|-47.7|-1.2||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||24 months|
1762454|NCT00121810|3235980|Superiority or Other||Mean Difference (Net)|-16.0||||0.108||95.0|-35.4|3.5||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||12 months|
1762455|NCT00121810|3235980|Superiority or Other||Median Difference (Net)|-10.8||||0.003||95.0|-17.9|-3.7||P value comparing the two treatment groups is calculated using ANCOVA with treatment and baseline calcineurin inhibitor type (cyclosporine or tacrolimus) as factors, and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||6 months|
1762456|NCT00121810|3235981|Superiority or Other||Mean Difference (Net)|4.3||||0.543||95.0|-9.6|18.2||P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) type as factors and baseline measurement and time from transplant to randomization as covariates.|ANCOVA||||
1762457|NCT00121810|3235982|Superiority or Other||Median Difference (Net)|18.7||||0.012||95.0|4.2|33.2||P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) as factors and baseline measurement and time from transplant to randomization as covariates.|ANCOVA|||The primary analysis tested the null hypothesis that mean percent change from baseline to 12 months for Group 1 (mycophenolate mofetil + sirolimus) was equal to that for Group 2 (mycophenolate mofetil + cyclosporine or tacrolimus) based on the intent-to-treat population.|
1762458|NCT00121719|3235984|Superiority or Other (legacy)|||||||0.0146|||||||Wilcoxon signed-rank test|||This was a pilot study and a statistical sample size calculation was not performed.|
1762459|NCT00121667|3236019|Superiority or Other||Mean Difference (Final Values)|-4845.0|Standard Error of the Mean|1175.1|<|0.0001|2-Sided|95.0|-7153.0|-2537.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment||
1762460|NCT00121667|3236019|Superiority or Other||Mean Difference (Final Values)|-6294.0|Standard Error of the Mean|1176.8|<|0.0001|2-Sided|95.0|-8606.0|-3983.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment||
1762461|NCT00121667|3236019|Superiority or Other||Mean Difference (Final Values)|-5599.0|Standard Error of the Mean|1168.2|<|0.0001|2-Sided|95.0|-7894.0|-3305.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment||
1762514|NCT00119158|3236208|Non-Inferiority or Equivalence|modified EASI (eczema area severity index) was considered equivalent if p value was greater than >0.05|||||<|0.05|||||||t-test, 2 sided||||
1762462|NCT00121667|3236020|Superiority or Other||Difference in Proportions|27.9|||<|0.0001|2-Sided|95.0|17.7|37.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.|||
1762463|NCT00121667|3236020|Superiority or Other||Difference in Proportions|27.0|||<|0.0001|2-Sided|95.0|17.0|36.7||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.|||
1762464|NCT00121667|3236020|Superiority or Other||Difference in Proportions|20.5|||<|0.0001|2-Sided|95.0|10.6|30.5||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.|||
1762465|NCT00121667|3236021|Superiority or Other||Mean Difference (Final Values)|-21.74|Standard Error of the Mean|3.6|<|0.0001|2-Sided|95.0|-28.81|-14.68||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment||
1762466|NCT00121667|3236021|Superiority or Other||Mean Difference (Final Values)|-23.28|Standard Error of the Mean|3.57|<|0.0001|2-Sided|95.0|-30.29|-16.27||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment||
1762467|NCT00121667|3236021|Superiority or Other||Mean Difference (Final Values)|-15.55|Standard Error of the Mean|3.56|<|0.0001|2-Sided|95.0|-22.55|-8.55||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment||
1762468|NCT00121667|3236022|Superiority or Other||Mean Difference (Final Values)|-0.72|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.91|-0.52||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF) .Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment||
1762469|NCT00121667|3236022|Superiority or Other||Mean Difference (Final Values)|-0.83|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-1.02|-0.63||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment||
1762470|NCT00121667|3236022|Superiority or Other||Mean Difference (Final Values)|-0.73|Standard Error of the Mean|0.1|<|0.0001|2-Sided|95.0|-0.92|-0.53||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model: difference between week t and baseline values = baseline values + treatment||
1762471|NCT00121641|3236057|Superiority or Other||Mean Difference (Final Values)|-7437.0|Standard Error of the Mean|1707.6|<|0.0001|2-Sided|95.0|-10798.0|-4076.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment||
1762472|NCT00121641|3236057|Superiority or Other||Mean Difference (Final Values)|-6249.0|Standard Error of the Mean|1675.1|<|0.0002|2-Sided|95.0|-9546.0|-2952.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment||
1762473|NCT00121641|3236057|Superiority or Other||Mean Difference (Final Values)|-6221.0|Standard Error of the Mean|1701.3|<|0.0003|2-Sided|95.0|-9570.0|-2872.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment||
1762474|NCT00121641|3236058|Superiority or Other||Difference in Proportions|17.1||||0.0133|2-Sided|95.0|2.8|31.0||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.|||
1762475|NCT00121641|3236058|Superiority or Other||Difference in Proportions|14.0||||0.0443|2-Sided|95.0|-0.1|27.6||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.|||
1762476|NCT00121641|3236058|Superiority or Other||Difference in Proportions|11.1||||0.1141|2-Sided|95.0|-3.1|24.9||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|Fisher Exact|The exact 95% CIs is based on the standardized statistic and inverting the one 2-sided test.|||
1762477|NCT00121641|3236059|Superiority or Other||Mean Difference (Final Values)|-22.81|Standard Error of the Mean|5.58|<|0.0001|2-Sided|95.0|-33.79|-11.84||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment||
1762478|NCT00121641|3236059|Superiority or Other||Mean Difference (Final Values)|-14.73|Standard Error of the Mean|5.48|<|0.0074|2-Sided|95.0|-25.5|-3.97||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment||
1762511|NCT00119678|3236183|Superiority or Other||Hazard Ratio (HR)|1.1|||||2-Sided|95.0|0.7|1.5|||||Cox proportional-hazards model was used to estimate the hazard ratio of abatacept versus placebo for SLE disease flare. The 95% two-sided confidence interval was provided for the hazard ratio for treatment.||
1762479|NCT00121641|3236059|Superiority or Other||Mean Difference (Final Values)|-20.6|Standard Error of the Mean|5.53|<|0.0002|2-Sided|95.0|-31.47|-9.72||Significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment||
1762480|NCT00121641|3236060|Superiority or Other||Mean Difference (Final Values)|-0.73|Standard Error of the Mean|0.15|<|0.0001|2-Sided|95.0|-1.02|-0.44||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment||
1762481|NCT00121641|3236060|Superiority or Other||Mean Difference (Final Values)|-0.64|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-0.93|-0.36||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment||
1762482|NCT00121641|3236060|Superiority or Other||Mean Difference (Final Values)|-0.62|Standard Error of the Mean|0.14|<|0.0001|2-Sided|95.0|-0.9|-0.33||Between-group comparisons significant at alpha = 0.019, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.|ANCOVA|Adjusted mean difference for saxagliptin groups vs placebo in Week 24 (LOCF). Adjusted for baseline.|ANCOVA model:post - pre = pre treatment||
1762483|NCT00121485|3236075|Non-Inferiority or Equivalence|200 patients (137 HMII and 67 XVE) provides 80% power (alpha= 0.05 (one-sided)) using a Blackwelder like analysis and a non-inferiority margin of 10%. The protocol specifies that once non-inferiority is proven, the data will be analyzed for superiority using closed testing methods.|Mean Difference (Final Values)|35.7||||2.5e-07|2-Sided|95.0|24.5|46.9||Two (2) interim analysis were pre-specified in the protocol. The type I error rate was preserved at 5% by use of the O’Brien-Fleming spending function.|Fisher Exact|||Primary endpoint is 2-yr survival free of stroke or re-operation to repair/replace the device. Patients are a success if composite endpoint achieved. Patients urgently transplanted due to device failure are failures. Patients electively transplanted after reversal of co-morbidity will be considered success if they achieve 2 years of survival from day of VAD implant and no stroke. HMII is a success if the proportion of HMII pts achieving the composite endpoint is equal to or better than HM XVE|
1762484|NCT00121238|3236087|Superiority or Other|||||||0.27|||||||Wilcoxon (Mann-Whitney)||||
1762485|NCT00121225|3236089|Superiority|||||||0.029|||||||Fisher Exact||||
1762486|NCT00120627|3236123|Superiority or Other||||||<|0.01|||||||ANOVA||||
1762487|NCT00120627|3236124|Superiority or Other||||||=|0|||||||ANOVA||||
1762488|NCT00120627|3236125|Superiority or Other||||||=|0|||||||ANOVA|||Post-hoc analysis|
1762489|NCT00120627|3236126|Superiority or Other||||||=|0|||||||ANOVA|||Somatization Subscale|
1762490|NCT00120627|3236126|Superiority or Other||||||=|0|||||||ANOVA|||Anxiety Subscale|
1762491|NCT00120627|3236126|Superiority or Other||||||<|0.001|||||||ANOVA|||Depression Subscale|
1762492|NCT00120627|3236127|Superiority or Other||||||<|0.05|||||||ANOVA|||2 group (treatment vs control) by 2 time (pre-intervention and post-intervention) ANOVA|
1762493|NCT00120627|3236128|Superiority or Other||||||<|0.01|||||||ANOVA||||
1762494|NCT00120627|3236129|Superiority or Other||||||<|0.001|||||||Mediation using Sobel Test||||
1762495|NCT00120627|3236129|Superiority or Other||||||<|0.001|||||||ANOVA||||
1762496|NCT00120627|3236130|Superiority or Other||||||<|0.0001|||||||ANOVA|||2 group (treatment vs control) by 2 time points (pre-intervention and post-intervention)|
1762497|NCT00120627|3236131|Superiority or Other||||||<|0.05|||||||ANOVA|||Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.|
1762498|NCT00120627|3236132|Superiority or Other||||||<|0.05|||||||Fisher Exact||||
1762499|NCT00120627|3236132|Superiority or Other||||||<|0.05|||||||ANOVA|F (1,144) = 4.12, p < .05||2 group (treatment vs. control) by 2 time (pre-intervention and post-intervention) one-way ANOVA|
1762500|NCT00120406|3236142|Superiority or Other||||||<|0.01||||||P-value has been adjusted for multiplicity.|Generalized estimating equation (GEE)||||
1762501|NCT00120406|3236143|Non-Inferiority or Equivalence|Non-inferiority margin is 10%.|||||<|0.01||||||P-value has been adjusted for multiplicity.|z-test, one-sided||||
1762502|NCT00120289|3236144|Superiority or Other||Hazard Ratio (HR)|1.17||||0.47|2-Sided|95.0|0.76|1.8|||Regression, Cox||||
1762503|NCT00120289|3236145|Superiority or Other||Hazard Ratio (HR)|1.13||||0.3|2-Sided|95.0|0.9|1.42|||Regression, Cox||||
1762504|NCT00120289|3236146|Superiority or Other||Hazard Ratio (HR)|1.08||||0.49|2-Sided|95.0|0.87|1.34|||Regression, Cox||||
1762505|NCT00120289|3236147|Superiority or Other||Hazard Ratio (HR)|1.02||||0.8|2-Sided|95.0|0.87|1.21|||Regression, Cox|Adjusting for gender and history of diabetes (randomization stratification factors).|||
1762506|NCT00120042|3236154|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1762507|NCT00120042|3236155|Superiority or Other|||||||0.05|||||||Chi-squared|||We planned that up to 300 women would be recruited. This sample size would achieve 80% poer at a 5% significance level to detect a reduction from 40% placental retention rate with no specific therapy (Group 1) to 20% with Group 2 or 3. An interim analysis was planned after 240 women had been recruited.|
1762508|NCT00119847|3236156|Superiority||Mean Difference (Net)|2.2||||0.23|2-Sided|95.0|-1.4|5.9||p<0.01 required for statistical significance|t-test, 2 sided||||
1762509|NCT00119847|3236157|Superiority||Mean Difference (Net)|3.0||||0.45|2-Sided|95.0|-4.8|10.7||p<0.01 required for statistical significance|t-test, 2 sided||||
1762510|NCT00119847|3236158|Superiority||Mean Difference (Net)|-0.04||||0.34|2-Sided|95.0|-0.12|0.04||p<0.05 required for statistical significance|t-test, 2 sided|||The planned sample size of 300 subjects was chosen to provide 80% power to detect a clinically relevant difference of 0.1 in the change in α1 from baseline to 1 year between the 2 treatment groups on the basis of data from prior studies that indicated that baseline levels of α1 would be 1.0 with a common SD of 0.2.|
1762512|NCT00119262|3236199|Superiority or Other|||||||0.32|||||||Fisher Exact||||
1762515|NCT00119041|3236210|Superiority or Other||||||>|0.25||||||Threshold for statistical significance was p<0.025 using Bonferroni correction for 2 statistical tests.|t-test, 2 sided|Threshold for statistical significance was p<0.025 using Bonferroni correction for 2 statistical tests.||Comparisons were made between the intervention and control groups at 18 months|
1762516|NCT00119041|3236210|Superiority or Other||||||>|0.153||||||Threshold for statistical significance was p<0.025 using Bonferroni correction for 2 statistical tests.|t-test, 2 sided|||Comparisons were made between the intervention and control groups at baseline|
1762517|NCT00119015|3236211|Superiority or Other||||||>|0.99|||||||Wilcoxon (Mann-Whitney)||||
1762518|NCT00119015|3236212|Superiority or Other|||||||0.48|||||||Wilcoxon (Mann-Whitney)||||
1762519|NCT00119015|3236213|Superiority or Other|||||||0.86|||||||Wilcoxon (Mann-Whitney)||||
1762520|NCT00119015|3236214|Superiority or Other|||||||0.7|||||||Wilcoxon (Mann-Whitney)||||
1762521|NCT00119015|3236215|Superiority or Other|||||||0.8|||||||Wilcoxon (Mann-Whitney)||||
1762522|NCT00118911|3236216|Superiority or Other||Slope|-0.12|Standard Deviation|0.59|>|0.05|2-Sided|95.0|-0.41|0.18|||Mixed Models Analysis||Those who were assigned to CBT and made a partial or full response maintained their gains over follow-up|We examined whether those in the CBT condition maintained their gains over time. Analysis was restricted to those assigned to CBT who were responders or partial responders.|
1762523|NCT00118911|3236217|Superiority or Other||Mean Difference (Final Values)|-4.631|Standard Deviation|7.337|<|0.03|2-Sided|95.0|-8.3|-0.963|||ANCOVA|We used multiple imputation.||Hypothesis was that CBT would be superior to RES|
1762524|NCT00118755|3236240|Superiority or Other||Hazard Ratio (HR)|1.14||||0.6294||95.0|0.66|1.97|||Log Rank||||
1762525|NCT00118755|3236241|Superiority or Other||Difference in Response Rate|9.8||||||95.0|0.9|18.7|||||95% Wald asymptotic CI using normal approximation (continuity corrected)||
1762526|NCT00118755|3236242|Superiority or Other||Hazard Ratio (HR)|0.85||||0.2458|2-Sided|95.0|0.64|1.12|||Log Rank||||
1762527|NCT00118755|3236243|Superiority or Other||Hazard Ratio (HR)|0.89||||0.3883|2-Sided|95.0|0.67|1.17|||Log Rank||||
1762528|NCT00118742|3236244|Superiority or Other||Mean Difference (Final Values)|23.6||||0.0006||95.0|10.2|37.0|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 24 months posttransplant|
1762529|NCT00118742|3236244|Superiority or Other||Mean Difference (Final Values)|18.2|||<|0.0001||95.0|9.9|26.6|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 12 months posttransplant|
1762530|NCT00118742|3236244|Superiority or Other||Median Difference (Final Values)|21.1|||<|0.0001||95.0|12.5|29.6|||ANCOVA|||Statistical analysis for calculated creatinine clearance at 6 months posttransplant|
1762531|NCT00118742|3236245|Superiority or Other||Mean Difference (Final Values)|28.7||||0.0053||95.0|13.7|43.7|||ANCOVA||||
1762532|NCT00118742|3236246|Superiority or Other||Mean Difference (Final Values)|25.6|||<|0.0001||95.0|15.7|35.6|||ANCOVA||||
1762533|NCT00118742|3236247|Superiority or Other||Mean Difference (Final Values)|24.9||||0.0012||95.0|14.8|35.0|||ANCOVA||||
1762534|NCT00118716|3236248|Superiority or Other||Mean Difference (Net)|0.01|Standard Error of the Mean|0.103||0.919|2-Sided|95.0|-0.19|0.21||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Endpoint.|
1762535|NCT00118716|3236248|Superiority or Other||Mean Difference (Net)|-0.02|Standard Error of the Mean|0.109||0.86|2-Sided|95.0|-0.23|0.2||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Week 4.|
1762536|NCT00118716|3236248|Superiority or Other||Mean Difference (Net)|-0.04|Standard Error of the Mean|0.094||0.7|2-Sided|95.0|-0.22|0.15||LS Mean Diff, SE, CI, and p-values are from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for overall score at Week 2.|
1762537|NCT00118716|3236248|Superiority or Other||Mean Difference (Net)|-0.06|Standard Error of the Mean|0.123||0.633|2-Sided|95.0|-0.3|0.18||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Endpoint.|
1762538|NCT00118716|3236248|Superiority or Other||Mean Difference (Net)|-0.07|Standard Error of the Mean|0.124||0.551|2-Sided|95.0|-0.32|0.17||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Week 4.|
1762539|NCT00118716|3236248|Superiority or Other||Mean Difference (Net)|-0.08|Standard Error of the Mean|0.112||0.464|2-Sided|95.0|-0.3|0.14|||ANCOVA|LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.||FSC 100/50mcg BID versus FP 100mcg BID for symptoms at Week 2.|
1762540|NCT00118716|3236248|Superiority or Other||Mean Difference (Net)|0.01|Standard Error of the Mean|0.103||0.903|2-Sided|95.0|-0.19|0.22||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Endpoint.|
1762541|NCT00118716|3236248|Superiority or Other||Mean Difference (Net)|-0.02|Standard Error of the Mean|0.111||0.828|2-Sided|95.0|-0.24|0.19||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Week 4.|
1762542|NCT00118716|3236248|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.096||0.294|2-Sided|95.0|-0.29|0.09||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for emotional function at Week 2.|
1762543|NCT00118716|3236248|Superiority or Other||Mean Difference (Net)|0.16|Standard Error of the Mean|0.133||0.222|2-Sided|95.0|-0.1|0.42||LS Mean Diff, SE, CI, and p-values are from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Endpoint.|
1762630|NCT00117598|3236477|Superiority or Other||Hazard Ratio (HR)|0.64||||0.0712|2-Sided|95.0|0.4|1.04|||Log Rank||HR from a cox model adjusted for baseline stratification factors||
1762544|NCT00118716|3236248|Superiority or Other||Mean Difference (Net)|0.11|Standard Error of the Mean|0.147||0.465|2-Sided|95.0|-0.18|0.4||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Week 4.|
1762545|NCT00118716|3236248|Superiority or Other||Mean Difference (Net)|0.18|Standard Error of the Mean|0.129||0.168|2-Sided|95.0|-0.08|0.43||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA|||FSC 100/50mcg BID versus FP 100mcg BID for activity limitation at Week 2|
1762546|NCT00118716|3236251|Superiority or Other||Mean Difference (Net)|3.7|Standard Error of the Mean|4.3||0.396|2-Sided|95.0|-4.8|12.1||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diffs were calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID PM PEF.|
1762547|NCT00118716|3236252|Superiority or Other||Mean Difference (Net)|8.1|Standard Error of the Mean|4.83||0.097|2-Sided|95.0|-1.5|17.6||LS Mean Diff, SE, CI, and p-values were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diffs were calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for AM PEF|
1762548|NCT00118716|3236253|Superiority or Other||Mean Difference (Net)|0.41|Standard Error of the Mean|0.085|<|0.001|2-Sided|95.0|0.24|0.58||LS Mean Diff, SE, CI, and p-value were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diff was calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for post-dose FEV1 AUC Day 1.|
1762549|NCT00118716|3236254|Superiority or Other||Mean Difference (Net)|3.0|Standard Error of the Mean|1.29||0.021|2-Sided|95.0|0.5|5.6||LS Mean Difference, SE, CI, and p-value were from an ANCOVA model with terms for treatment, investigator, age stratum, and baseline value.|ANCOVA||LS Mean Diff was calculated as FSC 100/50mcg BID-FP 100mcg BID.|FSC 100/50mcg BID versus FP 100mcg BID for maximal percent change in FEV1 following exercise challenge at Week 4.|
1762550|NCT00118703|3236255|Superiority or Other|||||||0.064|||||||Regression, Logistic|Overall evaluation of response to therapy was illustrated and analyzed using logistic regression adjusting for age, gender, investigator, and treatmen|||
1762551|NCT00118703|3236256|Superiority or Other||Mean Difference (Final Values)|0.061||||0.729|2-Sided|95.0|-0.29|0.41|||ANCOVA|The analysis method was adjusted for Baseline iTNSS, country, age, and gender, in addition to treatment effect.|||
1762552|NCT00118703|3236257|Superiority or Other||Mean Difference (Final Values)|0.094||||0.604|2-Sided|95.0|-0.26|0.45|||ANCOVA|The analysis method was adjusted for Baseline rTNSS, country, age, and gender, in addition to treatment effect.|||
1762553|NCT00118534|3236295|Superiority or Other||Odds Ratio (OR)|2.43|||<|0.001|2-Sided|95.0|1.58|3.74|||Regression, Logistic||||
1762554|NCT00118534|3236296|Superiority or Other||Odds Ratio (OR)|2.09||||0.007|2-Sided|95.0|1.22|3.59|||Regression, Logistic|||The target sample size (n=1400)was designed to have 90% power to detect the difference between 6% and 11% prolonged abstinence rates in SCC and IC, respectively, using a 2-sided .05 level Chi-square test. Final enrollment was 943. The recruitment period was not extended because the achieved sample size provided 78% power to detect the hypothesized prolonged abstinence rates, and the study continued to the end of planned follow-up.|
1762555|NCT00118430|3236301|Superiority or Other||||||<|0.001|||||||Poisson||||
1762556|NCT00118430|3236302|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis||||
1762557|NCT00118430|3236303|Superiority or Other||||||<|0.001||||||This reported p-value was calculated (and does not merely represent the threshold for significance.|Mixed Models Analysis||||
1762558|NCT00118430|3236304|Superiority or Other||||||<|0.001||||||This reported p-value was calculated (and does not merely represent the threshold for significance.|Mixed Models Analysis||||
1762559|NCT00118417|3236305|Superiority or Other|||||||0.061||||||T-test of PDSS change between baseline and endpoint of Phase 3|t-test, 2 sided|Degrees of Freedom = 17|||
1762560|NCT00118417|3236306|Superiority or Other|||||||0.97||||||T-test of PDSS change score|t-test, 2 sided|Degrees of Freedom = 22|||
1762561|NCT00118417|3236307|Superiority or Other|||||||0||||||Paired t-test between endpoint and baseline PDSS|t-test, 2 sided|Degrees of Freedom = 38|||
1762562|NCT00118404|3236308|Superiority or Other||Hazard Ratio, log|0.676|Standard Error of the Mean|0.24||0.05|2-Sided|95.0|0.42|1.08|||Log Rank|chi-square = 2.705, df = 1|Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO arm was reported.||
1762563|NCT00118404|3236308|Superiority or Other||Hazard Ratio (HR)|0.701|Standard Error of the Mean|0.27||0.09|2-Sided|95.0|0.41|1.19|||Log Rank|chi-square = 1.731, df = 1|Hazard of relapse/recurrence in the C-CT arm compared to PBO arm is reported.||
1762564|NCT00118404|3236308|Superiority or Other||Hazard Ratio (HR)|0.649|Standard Error of the Mean|0.28||0.61|2-Sided|95.0|0.37|1.13|||Log Rank|chi-square = 2.407, df = 1|Hazard of relapse/recurrence in the FLX arm compared tp C-CT arm was reported.||
1762565|NCT00118404|3236308|Superiority or Other||Hazard Ratio (HR)|1.075|Standard Error of the Mean|0.27||0.4|2-Sided|95.0|0.63|1.84|||Log Rank|chi-square = .07, df = 1|Hazard of relapse/recurrence for C-CT arm compared to FLX arm was reported.||
1762566|NCT00118404|3236309|Superiority or Other||Hazard Ratio (HR)|0.717|Standard Error of the Mean|0.26||0.1|2-Sided|95.0|0.43|1.2|||Log Rank|Chi-square = 1.595, df = 1|Hazard of relapse/recurrence in the active treatment (FLX or C-CT) arm compared to PBO (placebo)arm.||
1762567|NCT00118404|3236309|Superiority or Other||Hazard Ratio (HR)|0.715|Standard Error of the Mean|0.3||0.13|2-Sided|95.0|0.4|1.29|||Log Rank|chi-square = 1.262, df = 1|Hazard ratio of relapse/recurrence in the C-CT arm over the 20 months of follow-up since randomization compared to the pill placebo arm.||
1762568|NCT00118404|3236309|Superiority or Other||Hazard Ratio (HR)|0.717|Standard Error of the Mean|0.31||0.14|2-Sided|95.0|0.39|1.31|||Log Rank|Chi-square = 1.19, df = 1|Hazard ratio of relapse/recurrence in the Fluoxetine arm over the 20 months of follow-up since randomization compared to the pill placebo arm.||
1762569|NCT00118404|3236309|Superiority or Other||Hazard Ratio (HR)|0.988|Standard Error of the Mean|0.3||0.48|2-Sided|95.0|0.55|1.76|||Log Rank|log-rank chi-square = 0.002, df = 1|Hazard ratio for relapse/recurrence in the C-CT group compared to that in the fluoxetine group.||
1762570|NCT00118404|3236310|Superiority or Other||Hazard Ratio (HR)|0.501|Standard Error of the Mean|0.31||0.01|2-Sided|95.0|0.27|0.93|||Log Rank|log-rank chi-square = 5.06, df = 1|Hazard ratio for relapse in active treatment group (fluoxetine or C-CT) compared to that in the placebo group.||
1762571|NCT00118404|3236310|Superiority or Other||Hazard Ratio (HR)|0.519|Standard Error of the Mean|0.36||0.03|2-Sided|95.0|0.26|1.06|||Log Rank|log-rank chi-square = 3.391, df = 1|Hazard ratio for relapse in C-CT group compared to that in the placebo group.||
1762572|NCT00118404|3236310|Superiority or Other||Hazard Ratio (HR)|0.481|Standard Error of the Mean|0.38||0.02|2-Sided|95.0|0.23|1.01|||Log Rank|log-rank chi-square = 3.92, df = 1|Hazard Ratio for relapse in fluoxetine group compared to that in the pill placebo group.||
1762573|NCT00118404|3236310|Superiority or Other||Hazard Ratio (HR)|1.079|Standard Error of the Mean|0.39||0.42|2-Sided|95.0|0.5|2.34|||Log Rank|log-rank chi-square = 0.038, df = 1, p <=.42|Hazard ratio for relapse in C-CT group compared to that in the fluoxetine group.|The sample size was based on a predicted 30% difference in relapse/recurrence rates between C-CT and fluoxetine (ie,30% vs 60%) across both the experimental phase and the first 12 months of follow-up. With these assumptions, 180 randomized patients (60 per cell) were required to detect a statistically significant difference using a log-rank test with 1-sided α = 0.05 and 80% power.|
1762574|NCT00118378|3236311|Superiority or Other|||||||0.459|||||||ANOVA||||
1762575|NCT00118378|3236312|Superiority or Other|||||||0.15|||||||ANOVA|||Week 4 CD4 cell count|
1762576|NCT00118378|3236313|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1762577|NCT00118378|3236314|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1762578|NCT00118209|3236350|Superiority||Hazard Ratio (HR)|1.09||||0.6414|2-Sided|95.0|0.75|1.59|||Log Rank||||
1762579|NCT00118209|3236351|Superiority|||||||0.67|||||||t-test, 2 sided||||
1762580|NCT00118209|3236352|Superiority||Hazard Ratio (HR)|0.93||||0.6519|2-Sided|95.0|0.68|1.27|||Log Rank||||
1762581|NCT00117949|3236391|Superiority or Other||days|56.0||||||95.0|35.0|100.0|||||The upper confidence interval limit could not be calculated. For technical reasons it has been entered as 100.|Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.|
1762582|NCT00117949|3236391|Superiority or Other||days|56.0||||||95.0|35.0|84.0||||||Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.|
1762583|NCT00117949|3236391|Superiority or Other||days|56.0||||||95.0|35.0|56.0||||||Kaplan-Meier estimates of the time (days) to 90% reduction in PSA.|
1762584|NCT00117949|3236391|Superiority or Other|||||||0.926|||||||Log Rank||||
1762585|NCT00117949|3236392|Superiority or Other||days|28.0||||||95.0|14.0|41.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA|
1762586|NCT00117949|3236392|Superiority or Other||days|14.0||||||95.0|14.0|28.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA|
1762587|NCT00117949|3236392|Superiority or Other||days|14.0||||||95.0|14.0|28.0||||||Kaplan-Meier estimates of the time (days) to 50% reduction in PSA|
1762588|NCT00117949|3236392|Superiority or Other|||||||0.046|||||||Log Rank||||
1762589|NCT00117949|3236393|Superiority or Other||Percentage of participants|54.2||||||95.0|32.8|74.4||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.|
1762590|NCT00117949|3236393|Superiority or Other||Percentage of participants|79.2||||||95.0|57.8|92.9||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.|
1762591|NCT00117949|3236393|Superiority or Other||Percentage of participants|70.8||||||95.0|48.9|87.4||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.|
1762592|NCT00117949|3236393|Superiority or Other||Percentage of participants|10.0||||||95.0|0.3|44.5||||||Kaplan Meier-estimates of the percentage of participants with testostestone serum levels below 0.5 ng/mL for at least 28 days.|
1762593|NCT00117949|3236393|Superiority or Other|||||||0.181|||||||Cochran-Armitage Trend Test.||||
1762594|NCT00117949|3236394|Superiority or Other||Percentage of participants|35.6||||||95.0|15.8|55.5||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.|
1762595|NCT00117949|3236394|Superiority or Other||Percentage of participants|61.6||||||95.0|41.8|81.3||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.|
1762596|NCT00117949|3236394|Superiority or Other||Percentage of participants|42.7||||||95.0|22.0|63.4||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.|
1762597|NCT00117949|3236394|Superiority or Other||Percentage of participants|0.0||||||95.0|0.0|0.0||||||Kaplan-Meier estimates of the percentage of participants with sufficient testosterone suppression.|
1762598|NCT00117949|3236395|Superiority or Other||Median time to castration (days)|3.0||||||95.0|1.0|3.0||||||Kaplan-Meier estimates of the time to testosterone castration.|
1762599|NCT00117949|3236395|Superiority or Other||Median time to castration (days)|3.0||||||95.0|3.0|7.0||||||Kaplan-Meier estimates of the median time to testosterone castration.|
1762600|NCT00117949|3236395|Superiority or Other|||||||0.003|||||||Log Rank|Participants not castrated were censored as of the days from dosing for the last available observation.|||
1762601|NCT00117949|3236396|Superiority or Other||Median days to insufficient T response|35.0||||||95.0|14.0|98.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response|
1762602|NCT00117949|3236396|Superiority or Other||Median days to insufficient T response|98.0||||||95.0|70.0|126.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response|
1762603|NCT00117949|3236396|Superiority or Other||Median days to insufficient T response|84.0||||||95.0|35.0|112.0||||||Kaplan-Meier estimates of the time to meet insufficient testosterone (T) response.|
1762604|NCT00117949|3236396|Superiority or Other||||||<|0.001|||||||Log Rank||||
1762605|NCT00117806|3236399|Superiority or Other|||||||0.008|||||||Chi-squared||||
1762606|NCT00117793|3236405|Superiority or Other||||||=|0||||||Statistical significance was set a-priori at p < 0.05.|Mixed Models Analysis|The effect of study limb on limb pistoning was analyzed using repeated measures one-way analyses of variance.|||
1762631|NCT00117598|3236477|Superiority or Other||Hazard Ratio (HR)|0.39||||0.0004|2-Sided|95.0|0.23|0.67|||Log Rank||HR from a cox model adjusted for baseline stratification factors||
1762607|NCT00117793|3236406|Superiority or Other||||||=|0||||||Statistical significance was set a-priori at p < 0.05.|Mixed Models Analysis|The effect of study limb on activity level was analyzed using repeated measures one-way analyses of variance.|||
1762608|NCT00117793|3236407|Superiority or Other||||||>|0.05||||||Statistical significance was set a-priori at p < 0.05.|Mixed Models Analysis|The effect of study limb on limb volume was analyzed using repeated measures one-way analyses of variance.|||
1762609|NCT00117715|3236408|Other|||||||0.831||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log ((AAMU+1MX+1MU)/1,7,U) over time|
1762610|NCT00117715|3236409|Other|||||||0.194||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log(3HM/DX) over time|
1762611|NCT00117715|3236410|Other|||||||0.035||||||Post-hoc analysis performed using Tukey's Honestly Significant Difference test.|ANOVA|||Univariate analysis (ANOVA) of the change in log(DM/DX) over time|
1762612|NCT00117676|3236428|Superiority or Other||Difference in proportions|4.9|Standard Error of the Mean|5.3||0.359|2-Sided|95.0|-5.5|15.3||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and confidence interval are stratum adjusted (baseline ALT ≤ 2 x ULN or > 2 x ULN).|||
1762613|NCT00117676|3236429|Superiority or Other||Difference in proportions|-0.8|Standard Error of the Mean|4.8||0.859|2-Sided|95.0|-10.2|8.5||Statistical tests were not adjusted for baseline ALT stratum. Analysis set included only randomized and treated participants with baseline ALT > ULN (biochemically evaluable analysis set).|Z-test|P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.|||
1762614|NCT00117676|3236435|Superiority or Other||Difference in proportions|5.2|Standard Error of the Mean|5.0||0.293|2-Sided|95.0|-4.5|14.9||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Confidence interval stratum adjusted based on baseline ALT (≤ 2 x ULN, > 2 x ULN).|Z-test||||
1762615|NCT00117676|3236440|Superiority or Other||Difference in proportions|1.4|Standard Error of the Mean|3.4||0.672|2-Sided|95.0|-5.2|8.0||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Two-sided 95% confidence intervals, stratified by baseline ALT (baseline ALT ≤ 2 x ULN, > 2 x ULN), were used to evaluate treatment arm differences.|Z-test||||
1762616|NCT00117676|3236441|Superiority or Other||Difference in proportions|30.3|Standard Error of the Mean|4.6|<|0.001|2-Sided|95.0|21.3|39.2||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero. Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 2 x ULN or > 2 x ULN).|Z-test||||
1762617|NCT00117676|3236442|Non-Inferiority or Equivalence|With a sample size of 200 subjects in the tenofovir DF group and 100 subjects in the adefovir dipivoxil group, a two group large-sample normal approximation test of proportions with a one-sided 0.025 significance level would have 95% power to reject the null hypothesis that the tenofovir DF treatment was inferior to the adefovir dipivoxil treatment (difference in proportions was less than -0.100) in favor of the alternative hypothesis that the tenofovir DF treatment was not inferior.|Difference in proportions|23.5|Standard Error of the Mean|5.2|<|0.001|2-Sided|95.0|13.2|33.8||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted (baseline ALT ≥ 2 x ULN or > 2 x ULN) difference is 0.|Z-test|||A two-sided 95% confidence interval (CI), stratified by baseline ALT (≤ 2 x ULN or > 2 x ULN) was used to evaluate the difference (tenofovir DF – adefovir dipivoxil) in the proportion of complete responders between treatment groups.|
1762618|NCT00117637|3236453|Superiority or Other|||||||0.014|||||||Log Rank||||
1762619|NCT00117637|3236462|Superiority or Other|||||||0.019|||||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).|
1762620|NCT00117637|3236463|Superiority or Other|||||||0.001|||||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).|
1762621|NCT00117637|3236464|Superiority or Other|||||||0.005|||||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).|
1762622|NCT00117637|3236465|Superiority or Other|||||||0.067|||||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).|
1762623|NCT00117637|3236467|Superiority or Other|||||||0.073|||||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline).|
1762624|NCT00117637|3236469|Superiority or Other|||||||0.015|||||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline) and using the baseline respiratory score as covariate.|
1762625|NCT00117637|3236471|Superiority or Other|||||||0.022|||||||Mixed Models Analysis|||The least square (LS) means have been adjusted according to the stratification factors (geographical region, Motzer score at baseline) and using the baseline respiratory score as covariate.|
1762626|NCT00117637|3236473|Superiority or Other|||||||0.0004||||||the Cochran-Mantel-Haenszel statistics was stratified by region and Motzer risk category.|Cochran-Mantel-Haenszel||||
1762627|NCT00117637|3236474|Superiority or Other|||||||0.006||||||The Cochran-Mantel-Haenszel statistics was stratified by region and Motzer risk category.|Cochran-Mantel-Haenszel||||
1762628|NCT00117637|3236475|Superiority or Other||Hazard Ratio (HR)|0.882||||0.469|2-Sided|95.0|0.628|1.239||The log rank test is stratified by region (western Europe, Eastern Europe, USA) and by Motzer risk category (low, intermediate).|Log Rank|||The study was planned to show a 80% improvement in PFS for the group treated with Sorafenib compared to the group treated with Interferon, with a 80% power and a 2-sided type I error of 5%|
1762629|NCT00117637|3236476|Superiority or Other||Hazard Ratio (HR)|0.88||||0.5|2-Sided|95.0|0.61|1.27||The log rank test is stratified by region (western Europe, Eastern Europe, USA) and by Motzer risk category (low, intermediate).|Log Rank|||The study was planned to show a 80% improvement in PFS for the group treated with Sorafenib compared to the group treated with Interferon, with a 80% power and a 2-sided type I error of 5%|
1763144|NCT00113529|3236960|Superiority or Other|||||||0.509|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1762632|NCT00117598|3236478|Superiority or Other||Hazard Ratio (HR)|0.39|||<|0.0001|2-Sided|95.0|0.26|0.6|||Log Rank||HR from a cox model adjusted for baseline stratification factors||
1762633|NCT00117598|3236478|Superiority or Other||Hazard Ratio (HR)|0.36|||<|0.0001|2-Sided|95.0|0.23|0.56|||Log Rank||HR from a cox model adjusted for baseline stratification factors||
1762634|NCT00117598|3236480|Superiority or Other||Hazard Ratio (HR)|1.14|||||2-Sided|95.0|0.1|13.3|||||HR from a cox model adjusted for baseline stratification factors||
1762635|NCT00117598|3236480|Superiority or Other||Hazard Ratio (HR)|1.11|||||2-Sided|95.0|0.14|9.01|||||HR from a cox model adjusted for baseline stratification factors||
1762636|NCT00117598|3236481|Superiority or Other||Cox Proportional Hazard|0.98||||0.9515|2-Sided|95.0|0.6|1.62|||Log Rank||HR from a cox model adjusted for baseline stratification factors||
1762637|NCT00117598|3236481|Superiority or Other||Hazard Ratio (HR)|0.77||||0.3053|2-Sided|95.0|0.46|1.28|||Log Rank||HR from a cox model adjusted for baseline stratification factors||
1762638|NCT00117598|3236482|Superiority or Other|||||||0.6179|||||||Fisher Exact||||
1762639|NCT00117598|3236482|Superiority or Other|||||||0.0019|||||||Fisher Exact||||
1762640|NCT00117598|3236483|Superiority or Other||Hazard Ratio (HR)|0.41|||<|0.0001|2-Sided|95.0|0.26|0.65|||Log Rank||HR from a cox model adjusted for baseline stratification factors||
1762641|NCT00117598|3236483|Superiority or Other||Hazard Ratio (HR)|0.39|||<|0.0001|2-Sided|95.0|0.25|0.63|||Log Rank||HR from a cox model adjusted for baseline stratification factors|Two null hypotheses (Ho) tested: 1. PFS distributions for temsirolimus 175/75 mg and investigator’s choice treatment groups are identical. 2. PFS distributions for temsirolimus 175/25 mg and investigator's choice treatment groups are identical. Alternative hypothesis (Ha) for each test was that PFS distributions differed.|
1762642|NCT00117572|3236485|Superiority or Other|||||||0.09|||||||t-test, 2 sided||||
1762643|NCT00117572|3236486|Superiority or Other|||||||0.49|||||||t-test, 2 sided||||
1762644|NCT00117572|3236487|Superiority or Other|||||||0.83|||||||t-test, 2 sided||||
1762645|NCT00117572|3236488|Superiority or Other|||||||0.88|||||||t-test, 2 sided||||
1762646|NCT00117572|3236489|Superiority or Other|||||||0.96|||||||t-test, 2 sided||||
1762647|NCT00117572|3236490|Superiority or Other|||||||0.35|||||||t-test, 2 sided||||
1762648|NCT00117572|3236491|Superiority or Other|||||||0.034|||||||t-test, 2 sided||||
1762649|NCT00117572|3236492|Superiority or Other|||||||0.55|||||||t-test, 2 sided|Comparison of change scores between treatment groups|||
1762650|NCT00117572|3236493|Superiority or Other|||||||0.11|||||||Fisher Exact||||
1762651|NCT00117572|3236494|Superiority or Other|||||||0.57|||||||Fisher Exact||||
1762652|NCT00117572|3236495|Superiority or Other||Hazard Ratio (HR)|0.76||||0.16|2-Sided|95.0|0.51|1.12|||Log Rank||Hazard ratio is (Induction+CRT)/CRT||
1762653|NCT00117572|3236496|Superiority or Other||Hazard Ratio (HR)|0.83||||0.37|2-Sided|95.0|0.55|1.25|||Log Rank||Hazard ratio is (Induction+CRT)/CRT||
1762654|NCT00117572|3236497|Superiority or Other||Hazard Ratio (HR)|0.91||||0.68|2-Sided|95.0|0.59|1.41|||Log Rank||Hazard ratio is (Induction+CRT)/CRT|Comparison of overall survival curves|
1762655|NCT00117559|3236498|Superiority or Other||||||<|0.05|||||||ANOVA||||
1762656|NCT00117338|3236499|Superiority or Other|||||||0.58|||||||ANCOVA|ANCOVA model (Nonparametric) based on Tukey's normalized ranks with terms treatment, region (US, non-US) and baseline FEV1 as covariate|||
1762657|NCT00117338|3236500|Superiority or Other||Mean Difference (Final Values)|0.04||||0.173||95.0|-0.02|0.11|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate|||
1762658|NCT00117338|3236501|Superiority or Other||Mean Difference (Final Values)|0.01||||0.774||95.0|-0.06|0.08|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate|||
1762659|NCT00117338|3236502|Superiority or Other||Mean Difference (Final Values)|0.02||||0.612||95.0|-0.05|0.09|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate|||
1762660|NCT00117338|3236503|Superiority or Other||Odds Ratio (OR)|0.99||||0.975||95.0|0.61|1.61|||Regression, Logistic|Model terms: treatment and baseline FEV1 as covariate|||
1762661|NCT00117338|3236504|Superiority or Other||Mean Difference (Final Values)|0.02||||0.931||95.0|-0.41|0.45|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate|||
1762662|NCT00117338|3236505|Superiority or Other||Mean Difference (Final Values)|0.01||||0.775||95.0|-0.06|0.08|||ANCOVA|Model terms: treatment, region (US, non-US) and baseline FEV1 as covariate|||
1762663|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.601||||0.038|2-Sided|95.0|-1.17|-0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 28|
1762664|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.29||||0.245|2-Sided|95.0|-0.78|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 27|
1762665|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.233||||0.354|2-Sided|95.0|-0.73|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 26|
1762666|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.028||||0.909|2-Sided|95.0|-0.52|0.46|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 25|
1762667|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.398||||0.09|2-Sided|95.0|-0.86|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 24|
1762668|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.356||||0.15|2-Sided|95.0|-0.84|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 23|
1762669|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.499||||0.042|2-Sided|95.0|-0.98|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 22|
1762670|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.292||||0.232|2-Sided|95.0|-0.77|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 21|
1762671|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.348||||0.129|2-Sided|95.0|-0.8|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 20|
1762672|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.299||||0.194|2-Sided|95.0|-0.75|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 19|
1762673|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.326||||0.182|2-Sided|95.0|-0.81|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 18|
1762674|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.7||||0.003|2-Sided|95.0|-1.17|-0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 17|
1762675|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.484|||||2-Sided|95.0|-0.96|-0.01||||||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 16|
1762676|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.373||||0.109|2-Sided|95.0|-0.83|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 15|
1762677|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.3||||0.229|2-Sided|95.0|-0.79|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 14|
1762678|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.277||||0.252|2-Sided|95.0|-0.75|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 13|
1762679|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.432||||0.06|2-Sided|95.0|-0.88|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 12|
1762680|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.405||||0.09|2-Sided|95.0|-0.87|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 11|
1762681|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.481||||0.04|2-Sided|95.0|-0.94|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 10|
1762682|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.396||||0.084|2-Sided|95.0|-0.85|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 9|
1762683|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.385||||0.076|2-Sided|95.0|-0.81|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 8|
1762684|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.164||||0.456|2-Sided|95.0|-0.6|0.27|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 7|
1762685|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.282||||0.2|2-Sided|95.0|-0.71|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 6|
1762686|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.223||||0.278|2-Sided|95.0|-0.63|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 5|
1762687|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.244||||0.242|2-Sided|95.0|-0.65|0.17|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 4|
1762688|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.291||||0.162|2-Sided|95.0|-0.7|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 3|
1762689|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.279||||0.15|2-Sided|95.0|-0.66|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 2|
1762690|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.093||||0.643|2-Sided|95.0|-0.49|0.3|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 1|
1762691|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.725||||0.012|2-Sided|95.0|-1.29|-0.16|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 28|
1762692|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.307||||0.228|2-Sided|95.0|-0.81|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 27|
1762693|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.403||||0.114|2-Sided|95.0|-0.9|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 26|
1762966|NCT00114530|3236839|Superiority|||||||0.03|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.|
1762694|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.227||||0.357|2-Sided|95.0|-0.71|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 25|
1762695|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.546||||0.027|2-Sided|95.0|-1.03|-0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 24|
1762696|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.206||||0.404|2-Sided|95.0|-0.69|0.28|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 23|
1762697|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.419||||0.092|2-Sided|95.0|-0.91|0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 22|
1762698|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.568||||0.019|2-Sided|95.0|-1.04|-0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 21|
1762699|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.24||||0.321|2-Sided|95.0|-0.71|0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 20|
1762700|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.536||||0.023|2-Sided|95.0|-1.0|-0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 19|
1762701|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.262||||0.249|2-Sided|95.0|-0.71|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 18|
1762702|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.495||||0.04|2-Sided|95.0|-0.97|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 17|
1762703|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.619||||0.009|2-Sided|95.0|-1.08|-0.16|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 16|
1762704|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.475||||0.043|2-Sided|95.0|-0.94|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 15|
1762705|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.299||||0.191|2-Sided|95.0|-0.75|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 14|
1762706|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.188||||0.431|2-Sided|95.0|-0.66|0.28|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 13|
1762707|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.226||||0.32|2-Sided|95.0|-0.67|0.22|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 12|
1762708|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.302||||0.183|2-Sided|95.0|-0.75|0.14|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 11|
1762709|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.452||||0.046|2-Sided|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 10|
1762710|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.206||||0.372|2-Sided|95.0|-0.66|0.25|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 9|
1762711|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.111||||0.621|2-Sided|95.0|-0.55|0.33|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 8|
1762712|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.406||||0.071|2-Sided|95.0|-0.85|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 7|
1762713|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.296||||0.178|2-Sided|95.0|-0.73|0.14|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 6|
1762714|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.146||||0.475|2-Sided|95.0|-0.55|0.26|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 5|
1762715|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.343||||0.084|2-Sided|95.0|-0.73|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 4|
1762716|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.255||||0.205|2-Sided|95.0|-0.65|0.14|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 3|
1762717|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.231||||0.236|2-Sided|95.0|-0.61|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 2|
1762718|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.32||||0.095|2-Sided|95.0|-0.7|0.06|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 1|
1763145|NCT00113529|3236960|Superiority or Other|||||||1|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1762719|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.645||||0.017|2-Sided|95.0|-1.17|-0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 28|
1762720|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.283||||0.234|2-Sided|95.0|-0.75|0.18|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 27|
1762721|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.317||||0.186|2-Sided|95.0|-0.79|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 26|
1762722|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.157||||0.505|2-Sided|95.0|-0.62|0.31|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 25|
1762723|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.479||||0.034|2-Sided|95.0|-0.92|-0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 24|
1762724|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.312||||0.179|2-Sided|95.0|-0.77|0.14|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 23|
1762725|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.454||||0.044|2-Sided|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 22|
1762726|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.424||||0.063|2-Sided|95.0|-0.87|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 21|
1762727|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.315||||0.152|2-Sided|95.0|-0.75|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 20|
1762728|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.449||||0.039|2-Sided|95.0|-0.87|-0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 19|
1762729|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.301||||0.175|2-Sided|95.0|-0.74|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 18|
1762730|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.59||||0.009|2-Sided|95.0|-1.03|-0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 17|
1762731|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.566||||0.011|2-Sided|95.0|-1.0|-0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 16|
1762732|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.415||||0.056|2-Sided|95.0|-0.84|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 15|
1762733|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.342||||0.123|2-Sided|95.0|-0.78|0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 14|
1762734|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.25||||0.261|2-Sided|95.0|-0.69|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 13|
1762735|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.333||||0.111|2-Sided|95.0|-0.74|0.08|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 12|
1762736|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.314||||0.15|2-Sided|95.0|-0.74|0.11|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 11|
1762737|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.453||||0.034|2-Sided|95.0|-0.87|-0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 10|
1762738|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.373||||0.081|2-Sided|95.0|-0.79|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 9|
1762739|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.245||||0.22|2-Sided|95.0|-0.64|0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 8|
1762740|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.297||||0.142|2-Sided|95.0|-0.69|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 7|
1762741|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.301||||0.137|2-Sided|95.0|-0.7|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 6|
1762742|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.13||||0.483|2-Sided|95.0|-0.49|0.23|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 5|
1762967|NCT00114530|3236840|Superiority|||||||0.3|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.|
1762743|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.278||||0.131|2-Sided|95.0|-0.64|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 4|
1762744|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.31||||0.091|2-Sided|95.0|-0.67|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 3|
1762745|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.263||||0.134|2-Sided|95.0|-0.61|0.08|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 2|
1762746|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.222||||0.194|2-Sided|95.0|-0.56|0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 1|
1762747|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.659||||0.018|2-Sided|95.0|-1.2|-0.11|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 28|
1762748|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.48||||0.056|2-Sided|95.0|-0.97|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 27|
1762749|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.576||||0.019|2-Sided|95.0|-1.06|-0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 26|
1762750|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.43||||0.079|2-Sided|95.0|-0.91|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 25|
1762751|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.464||||0.062|2-Sided|95.0|-0.95|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 24|
1762752|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.474||||0.055|2-Sided|95.0|-0.96|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 23|
1762753|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.595||||0.014|2-Sided|95.0|-1.07|-0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 22|
1762754|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.281||||0.243|2-Sided|95.0|-0.76|0.19|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 21|
1762755|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.222||||0.348|2-Sided|95.0|-0.69|0.24|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 20|
1762756|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.633||||0.007|2-Sided|95.0|-1.09|-0.17|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 19|
1762757|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.457||||0.044|2-Sided|95.0|-0.9|-0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 18|
1762758|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.563||||0.019|2-Sided|95.0|-1.03|-0.09|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 17|
1762759|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.43||||0.064|2-Sided|95.0|-0.89|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 16|
1762760|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.38||||0.094|2-Sided|95.0|-0.82|0.07|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 15|
1762761|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.235||||0.297|2-Sided|95.0|-0.68|0.21|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 14|
1762762|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.344||||0.145|2-Sided|95.0|-0.81|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 13|
1762763|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.34||||0.151|2-Sided|95.0|-0.8|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 12|
1762764|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.172||||0.469|2-Sided|95.0|-0.64|0.29|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 11|
1762765|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.464||||0.048|2-Sided|95.0|-0.92|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 10|
1762766|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.191||||0.383|2-Sided|95.0|-0.62|0.24|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 9|
1764483|NCT00095498|3239348|Superiority or Other||||||<|0.001|||||||van Elteren Stratified Rank Test||||
1762767|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.231||||0.296|2-Sided|95.0|-0.67|0.2|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 8|
1762768|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.376||||0.082|2-Sided|95.0|-0.8|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 7|
1762769|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.573||||0.008|2-Sided|95.0|-1.0|-0.15|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 6|
1762770|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.298||||0.164|2-Sided|95.0|-0.72|0.12|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 5|
1762771|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.262||||0.187|2-Sided|95.0|-0.65|0.13|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 4|
1762772|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.393||||0.052|2-Sided|95.0|-0.79|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 3|
1762773|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.325||||0.089|2-Sided|95.0|-0.7|0.05|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 2|
1762774|NCT00117325|3236506|Superiority or Other||Mean Difference (Net)|-0.45||||0.011|2-Sided|95.0|-0.8|-0.1|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 1|
1762775|NCT00117325|3236507|Superiority or Other||Mean Difference (Net)|-0.111||||0.1|2-Sided|95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip|
1762776|NCT00117325|3236507|Superiority or Other||Mean Difference (Net)|-0.111||||0.1||95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion|
1762777|NCT00117325|3236507|Superiority or Other||Mean Difference (Net)|-0.096||||0.136|2-Sided|95.0|-0.22|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea|
1762778|NCT00117325|3236508|Superiority or Other||Mean Difference (Net)|-0.093||||0.164|2-Sided|95.0|-0.22|0.04|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg for post-nasal drip|
1762779|NCT00117325|3236508|Superiority or Other||Mean Difference (Net)|-0.124||||0.076|2-Sided|95.0|-0.26|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Nasal congestion|
1762780|NCT00117325|3236508|Superiority or Other||Mean Difference (Net)|-0.132||||0.048|2-Sided|95.0|-0.26|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for rhinorrhea|
1762781|NCT00117325|3236509|Superiority or Other||Mean Difference (Net)|-0.112||||0.106|2-Sided|95.0|-0.25|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip|
1762782|NCT00117325|3236509|Superiority or Other||Mean Difference (Net)|-0.164||||0.015|2-Sided|95.0|-0.3|-0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion|
1762783|NCT00117325|3236509|Superiority or Other||Mean Difference (Net)|-0.113||||0.087|2-Sided|95.0|-0.24|0.02|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea|
1762784|NCT00117325|3236510|Superiority or Other||Mean Difference (Net)|-0.095||||0.138|2-Sided|95.0|-0.22|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip|
1762785|NCT00117325|3236510|Superiority or Other||Mean Difference (Net)|-0.124||||0.061|2-Sided|95.0|-0.25|0.01|||ANCOVA|||Placebo versus Fluticasone Furoate 110 mcg QD for Nasal Congestion|
1762786|NCT00117325|3236510|Superiority or Other||Mean Difference (Net)|-0.118||||0.061|2-Sided|95.0|-0.24|0.01|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea|
1762787|NCT00117325|3236511|Superiority or Other||Mean Difference (Net)|-6.372||||0.023|2-Sided|95.0|-11.8|-0.9|||ANCOVA|ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.|
1762788|NCT00117325|3236512|Superiority or Other||Mean Difference (Net)|-4.51||||0.093|2-Sided|95.0|-9.77|0.75|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.|
1762789|NCT00117325|3236513|Superiority or Other||Mean Difference (Net)|-0.304||||0.076|2-Sided|95.0|-0.64|0.03|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis|
1762790|NCT00117325|3236514|Superiority or Other||Mean Difference (Net)|-0.348||||0.051|2-Sided|95.0|-0.7|0.0|||ANCOVA|ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.|
1762923|NCT00115765|3236746|Superiority or Other||Hazard Ratio (HR)|1.43||||0.005||95.0|1.11|1.83|||Regression, Cox|Model covariates were ECOG status, prior chemotherapy, metastatic organs, disease site, oxaliplatin dose < 85 mg/m2, and oxaliplatin dose > 100 mg/m2|||
1762791|NCT00117325|3236515|Superiority or Other|||||||0.184|||||||Regression, Logistic|logistic regression adjusting for age, gender, investigator, and treatment.||Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis.|Effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period (Total response) was analyzed.
1762792|NCT00117325|3236516|Superiority or Other||Mean Difference (Net)|-0.393||||0.027|2-Sided|95.0|-0.74|-0.05||Week 1-4|ANCOVA|ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.|
1762793|NCT00117325|3236517|Superiority or Other||Mean Difference (Net)|-0.335||||0.05|2-Sided|95.0|-0.67|0.0|||ANCOVA|Analysis of covariance (ANCOVA) method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.||Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.|
1762794|NCT00116844|3236537|Superiority or Other|||||||0.0331|||||||Prescott’s method||||
1762795|NCT00116844|3236538|Superiority or Other|||||||0.229|||||||Nonparametric tests-Wilcoxon Rank Sum||||
1762796|NCT00116844|3236539|Superiority or Other|||||||0.8|||||||Nonparametric tests-Wilcoxon Rank Sum||||
1762797|NCT00116844|3236540|Superiority or Other||||||<|0.001|||||||Prescott’s method||||
1762798|NCT00116844|3236541|Superiority or Other||||||<|0.001|||||||Nonparametric tests-Wilcoxon Rank Sum||||
1762799|NCT00116844|3236542|Superiority or Other||||||<|0.001|||||||Nonparametric tests-Wilcoxon Rank Sum||||
1762800|NCT00116831|3236546|Superiority or Other||Treatment difference (RSG-GLP)|0.14||||||95.0|||||||||
1762801|NCT00116831|3236547|Superiority or Other||Treatment difference (RSG-GLP)|0.118||||||95.0|||||||||
1762802|NCT00116831|3236548|Superiority or Other||Treatment difference (RSG-GLP)|0.0164||||||95.0|||||||||
1762803|NCT00116831|3236549|Superiority or Other||Treatment difference (RSG-GLP)|-0.462||||||95.0|||||||||
1762804|NCT00116831|3236550|Superiority or Other||Treatment difference (RSG-GLP)|-14.478||||||95.0|||||||||
1762805|NCT00116831|3236551|Superiority or Other||Treatment difference (RSG-GLP)|-6.768||||||95.0|||||||||
1762806|NCT00116831|3236552|Superiority or Other||Treatment difference (RSG-GLP)|11.728||||||95.0|||||||||
1762807|NCT00116831|3236553|Superiority or Other||Treatment difference (RSG-GLP)|3.998||||||95.0|||||||||
1762808|NCT00116831|3236554|Superiority or Other||Treatment difference (RSG-GLP)|15.731||||||95.0|||||||||
1762809|NCT00116831|3236555|Superiority or Other||Treatment difference (RSG-GLP)|7.316||||||95.0|||||||||
1762810|NCT00116831|3236556|Superiority or Other||Treatment difference (RSG-GLP)|7.642||||||95.0|||||||||
1762811|NCT00116831|3236557|Superiority or Other||Ratio to GLP as % difference from GLP|30.591||||||95.0|||||||||
1762812|NCT00116831|3236559|Superiority or Other||Treatment difference (RSG-GLP)|-16.9||||||95.0|||||||||
1762813|NCT00116831|3236560|Superiority or Other||Treatment difference (RSG-GLP)|-47.23||||||95.0|||||||||
1762814|NCT00116831|3236561|Superiority or Other||Treatment difference (RSG-GLP)|-0.88||||||95.0|||||||||
1762815|NCT00116831|3236562|Superiority or Other||Treatment difference (RSG-GLP)|-0.1||||||95.0|||||||||
1762816|NCT00116831|3236563|Superiority or Other||Model adjusted mean diff. (RSG-GLP)|-0.11||||||95.0|||||||||
1762817|NCT00116831|3236565|Superiority or Other||Model adjusted mean diff. (RSG-GLP)|-1.72||||||95.0|||||||||
1762818|NCT00116831|3236567|Superiority or Other||Model adjusted mean diff. (RSG-GLP)|-5.12||||||95.0|||||||||
1762819|NCT00116831|3236568|Superiority or Other||Model adjusted mean diff. (RSG-GLP)|-0.64||||0.1221||95.0|-1.457|0.173|||ANCOVA||||
1762820|NCT00116831|3236571|Superiority or Other||Mean diff (RSG-GLP) for vessel area|-0.11||||||95.0|||||||||
1762821|NCT00116831|3236572|Superiority or Other||Mean diff (RSG-GLP) for lumen area|0.02||||||95.0|||||||||
1762822|NCT00116831|3236573|Superiority or Other||Mean diff (RSG-GLP) for atheroma area|-0.13||||||95.0|||||||||
1762823|NCT00116831|3236575|Superiority or Other||Mean diff (RSG-GLP) for vessel volume|-3.56||||||95.0|||||||||
1762824|NCT00116831|3236576|Superiority or Other||Mean diff (RSG-GLP) for lumen volume|0.32||||||95.0|||||||||
1762825|NCT00116831|3236577|Superiority or Other||Mean diff (RSG-GLP) for atheroma volume|-4.58||||||95.0|||||||||
1762826|NCT00116805|3236590|Superiority or Other||Difference in proportions|0.9|Standard Error of the Mean|2.6||0.733|2-Sided|95.0|-4.2|5.9||P-value above corresponds to Z-test of the null hypothesis that stratum-adjusted difference is zero. Difference, standard error of the difference, and CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or > 4 x ULN).|Z-test|||This information pertains to seroconversion to anti-HBs.|
1762827|NCT00116805|3236590|Superiority or Other||Difference in proportions|0.9|Standard Error of the Mean|2.9||0.757|2-Sided|95.0|-4.8|6.5||P-value above for HBsAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero. Difference, standard error of the difference, and CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or > 4 x ULN).|Z-test|||This information pertains to HBsAg loss.|
1762828|NCT00116805|3236591|Superiority or Other||Difference in proportions|4.3|Standard Error of the Mean|3.0||0.148|2-Sided|95.0|-1.5|10.2||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero. Difference, standard error of the difference, and confidence interval (CI) are stratum adjusted (baseline ALT ≤ 4 x ULN or > 4 x ULN).|Z-test|||This information pertains to HBsAg seroconversion.|
1762829|NCT00116805|3236591|Superiority or Other||Difference in proportions|10.9|Standard Error of the Mean|4.6||0.018|2-Sided|95.0|1.9|19.9||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero. Difference, standard error of the difference, and confidence interval (CI) are stratum adjusted (baseline ALT ≤ 4 x ULN or > 4 x ULN).|Z-test|||This information pertains to HBsAg loss.|
1762830|NCT00116805|3236592|Superiority or Other||Difference in proportions|0.7|Standard Error of the Mean|5.6||0.904|2-Sided|95.0|-10.4|11.7||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or >4 x ULN).||This information pertains to seroconversion to anti-HBe.|
1763146|NCT00113529|3236960|Superiority or Other|||||||0.02|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1762831|NCT00116805|3236592|Superiority or Other||Difference in proportions|0.3|Standard Error of the Mean|5.9||0.963|2-Sided|95.0|-11.3|11.9||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or > 4 x ULN).||This information pertains to HBeAg loss.|
1762832|NCT00116805|3236593|Superiority or Other||Difference in proportions|4.7|Standard Error of the Mean|5.2||0.363|2-Sided|95.0|-5.5|14.9||P-value for HBeAg seroconversion corresponds to Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or > 4 x ULN).||This information pertains to HBeAg seroconversion.|
1762833|NCT00116805|3236593|Superiority or Other||Difference in proportions|6.1|Standard Error of the Mean|5.3||0.245|2-Sided|95.0|-4.2|16.4||P-value above for HBeAg loss corresponds to a Z-test of the null hypothesis that stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and Cl are stratum adjusted based on baseline ALT category (≤ 4 x ULN or > 4 x ULN).||This information pertains to HBeAg loss.|
1762834|NCT00116805|3236598|Superiority or Other||Difference in proportions|-9.8|Standard Error of the Mean|6.0||0.1|2-Sided|95.0|-21.5|1.9||P-value corresponds to a Z-test of the null hypothesis that the ALT stratum-adjusted difference is zero.|Z-test|Difference, standard error of the difference, and CI are stratum adjusted (baseline ALT ≤ 4 x ULN or > 4 x ULN).|||
1762835|NCT00116805|3236599|Superiority or Other||Difference in proportions|13.6|Standard Error of the Mean|6.4||0.032|2-Sided|95.0|1.1|26.1||P-value corresponds to a Z-test. Statistical tests were not adjusted for baseline ALT stratum.|Z-test|Difference, standard error of the difference, and CI are stratum adjusted (baseline ALT ≤ 4 x ULN or > 4 x ULN).|||
1762836|NCT00116805|3236605|Superiority or Other||Difference in proportions|5.8|Standard Error of the Mean|5.8||0.32|2-Sided|95.0|-5.6|17.2||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference in zero. Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or > 4 x ULN).|Z-test||||
1762837|NCT00116805|3236610|Superiority or Other||Difference in proportions|-1.4|Standard Error of the Mean|5.4||0.801|2-Sided|95.0|-12.0|9.3||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference is zero.|Z-test|Two-sided 95% CIs, stratified by baseline ALT (baseline ALT ≤ 4 x ULN or > 4 x ULN), were used to evaluate treatment group differences.|||
1762838|NCT00116805|3236611|Superiority or Other||Difference in proportions|63.1|Standard Error of the Mean|4.7|<|0.001|2-Sided|95.0|53.8|72.3||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted difference in zero.|Z-test|Difference, standard error of the difference, and the CI are stratum adjusted based on baseline ALT category (≤ 4 x ULN or > 4 x ULN).|||
1762839|NCT00116805|3236612|Non-Inferiority or Equivalence|With a sample size of 160 subjects in the TDF group and 80 subjects in the ADV group, a two group large-sample normal approximation test of proportions with a one-sided 0.025 significance level would have 95% power to reject the null hypothesis that the TDF treatment was inferior to the ADV treatment (the difference in proportions was less than -0.080) in favor of the alternative hypothesis that the TDF treatment was not inferior.|Difference in proportions|54.1|Standard Error of the Mean|4.8|<|0.001|2-Sided|95.0|44.6|63.6||P-value corresponds to a Z-test of the null hypothesis that the stratum-adjusted (baseline ALT ≤ 4 x upper limit of the normal range [ULN] or > 4 x ULN) difference is 0.|Z-test|2-sided 95% confidence interval (CI), stratified by baseline ALT was used to evaluate difference between groups in proportion of complete responders.|||
1762840|NCT00116779|3236622|Superiority or Other|||||||0.778|||||||Log Rank|||Days to 90% reduction|
1762841|NCT00116779|3236622|Superiority or Other|||||||0.904|||||||Log Rank|||Time to 50% reduction|
1762842|NCT00116779|3236623|Superiority or Other||Percentage of participants|98.0||||||95.0|87.0|100.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.||
1762843|NCT00116779|3236623|Superiority or Other||Percentage of participants|93.0||||||95.0|82.0|99.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.||
1762844|NCT00116779|3236624|Superiority or Other|||||||0.8413|||||||Chi-squared||||
1762845|NCT00116779|3236624|Superiority or Other||Percentage of participants|89.0||||||95.0|78.0|95.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.||
1762846|NCT00116779|3236624|Superiority or Other||Percentage of participants|90.0||||||95.0|79.0|96.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.||
1762847|NCT00116779|3236625|Superiority or Other||Percentage of participants|77.0||||||95.0|64.0|88.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.||
1762848|NCT00116779|3236625|Superiority or Other||Percentage of participants|86.0||||||95.0|73.0|94.0|||||The 95% confidence interval was calculated by Clopper-Pearson method.||
1762849|NCT00116753|3236628|Superiority or Other||Percentage of participants|97.9|||||2-Sided|95.0|94.0|100.0|||||Estimated value is the percentage of participants with testosterone <=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.||
1762850|NCT00116753|3236628|Superiority or Other||Percentage of participants|97.9|||||2-Sided|95.0|94.0|100.0|||||Estimated value is the percentage of participants with testosterone <=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.||
1762851|NCT00116753|3236628|Superiority or Other||Percentage of participants|97.3|||||2-Sided|95.0|93.0|99.0|||||Estimated value is the percentage of participants with testosterone <=0.5 ng/mL at Day 28. Measure dispersion is the 95% two-sided confidence interval which was calculated by the Clopper-Pearson method.||
1762852|NCT00116753|3236629|Superiority or Other|||||||0.2072|||||||Mantel Haenszel||||
1762853|NCT00116753|3236629|Superiority or Other|||||||0.2579|||||||Mantel Haenszel||||
1762854|NCT00116753|3236629|Superiority or Other|||||||0.9587|||||||Mantel Haenszel||||
1762855|NCT00116753|3236629|Superiority or Other|||||||0.383|||||||Mantel Haenszel||||
1762856|NCT00116753|3236629|Superiority or Other||Percentage of participants|86.0|||||2-Sided|96.5|78.0|92.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study <=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.||
1762857|NCT00116753|3236629|Superiority or Other||Percentage of participants|80.2|||||2-Sided|96.5|72.0|87.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study <=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.||
1762858|NCT00116753|3236629|Superiority or Other||Percentage of participants|80.7|||||2-Sided|96.5|72.0|88.0|||||Estimated value is the percentage of participants with all testosterone values from after Day 28 to end of study <=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.||
1762859|NCT00116753|3236630|Superiority or Other|||||||0.2208|||||||Mantel Haenszel||||
1762860|NCT00116753|3236630|Superiority or Other|||||||0.1557|||||||Mantel Haenszel||||
1762861|NCT00116753|3236630|Superiority or Other|||||||0.7797|||||||Mantel Haenszel||||
1762862|NCT00116753|3236630|Superiority or Other|||||||0.3022|||||||Mantel Haenszel||||
1762863|NCT00116753|3236630|Superiority or Other||Percentage of participants|85.3|||||2-Sided|96.5|77.0|91.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study <=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.||
1762864|NCT00116753|3236630|Superiority or Other||Percentage of participants|79.5|||||2-Sided|96.5|71.0|87.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study <=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.||
1762865|NCT00116753|3236630|Superiority or Other||Percentage of partcipants|78.3|||||2-Sided|96.5|69.0|86.0|||||Estimated value is the percentage of participants with all testosterone values from Day 28 to end of study <=0.5 ng/mL. Measure dispersion is the 96.5% two-sided confidence interval which was calculated by the Clopper-Pearson method.||
1762866|NCT00116584|3236641|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1762867|NCT00116584|3236642|Superiority||||||<|0.05|||||||Wilcoxon (Mann-Whitney)||||
1762868|NCT00116584|3236643|Superiority||||||<|0.05|||||||Fisher Exact||||
1762869|NCT00116428|3236653|Superiority or Other||||||<|0.001|||||||Log Rank|||The study null hypothesis is that the chronic success rates for the THERMOCOOL and AAD groups are equal.|
1762870|NCT00116337|3236655|Other||||||<|0.05|||||||nonparametric analog (Freidman Test)|||The data prior to implantation were compared with data obtained after implantation of the cough system using a nonparametric analog (Freidman Test) to the standard repeated measures analysis of variance. Statistical significance was assumed at P<0.05. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± SEs.|
1762871|NCT00116337|3236657|Other|Statistical analyses was performed using a repeated measures analysis of variance and Paired t test. A p value of < 0.05 was taken as indicating statistical significance.|||||<|0.05|||||||ANOVA|Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.||Each patient was served as their own control; comparisons was made at various points in the study. Clinical parameters was assessed before the study and also at several end points following the Reconditioning Phase.|
1762872|NCT00116272|3236658|Superiority or Other||Odds Ratio (OR)|1.04|||||2-Sided|95.0|0.65|1.69|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.||
1762873|NCT00116272|3236660|Superiority or Other||Odds Ratio (OR)|1.28|||||2-Sided|95.0|0.47|4.02|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to no confirmed confounder.||
1762874|NCT00116272|3236661|Superiority or Other||Odds Ratio (OR)|0.88|||||2-Sided|95.0|0.29|2.65|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.||
1762875|NCT00116272|3236662|Superiority or Other||Odds Ratio (OR)|1.17|||||2-Sided|95.0|0.43|3.14|||||Computed using logistic regression, adjusted for propensity score comprised of country (U.S., Canada), primary disease, and maternal height.||
1762876|NCT00116272|3236663|Superiority or Other||Odds Ratio (OR)|0.78|||||2-Sided|95.0|0.37|1.62|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, RA disease severity score at 32 weeks, and disease severity score imputation indicator.||
1762877|NCT00116272|3236664|Superiority or Other||Adjusted Difference|0.27|||||2-Sided|95.0|-6.12|6.65|||||Computed using linear regression. Directly adjusted for infant sex and other autoimmune diseases because propensity score adjustment was not balanced.||
1762878|NCT00116272|3236665|Superiority or Other||Adjusted Difference|1.53|||||2-Sided|95.0|-5.76|8.81|||||Computed using linear regression, adjusted for propensity score comprised of maternal height, maternal age (categorical), and referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other).||
1762879|NCT00116272|3236666|Superiority or Other||Adjusted Difference|0.2|||||2-Sided|95.0|-7.59|7.99|||||Computed using linear regression, adjusted for propensity score comprised of maternal height, vitamin use, primary disease, RA disease severity score at 32 weeks, PsO disease severity score at intake & 32 weeks, disease severity imputation indicators||
1762880|NCT00116272|3236667|Superiority or Other||Odds Ratio (OR)|0.79|||||2-Sided|95.0|0.4|1.57|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, & disease severity imputation indicator||
1762881|NCT00116272|3236668|Superiority or Other||Odds Ratio (OR)|0.72|||||2-Sided|95.0|0.31|1.68|||||Unadjusted Odds Ratio computed using logistic regression. An adjusted estimate was not computed due to the small number of events.||
1762882|NCT00116272|3236669|Superiority or Other||Odds Ratio (OR)|0.48|||||2-Sided|95.0|0.22|1.05|||||Computed using logistic regression, adjusted for propensity score comprised of maternal height, referral source (OTIS, Sponsor/HCP, Patient Support Group/Internet/Other), PsO disease severity score at 32 weeks, & disease severity imputation indicator||
1762883|NCT00116272|3236670|Superiority or Other||Adjusted Difference|-0.09|||||2-Sided|95.0|-0.43|0.26|||||Computed using linear regression, adjusted for maternal age (categorical).||
1762884|NCT00116272|3236671|Superiority or Other||Adjusted Difference|0.1|||||2-Sided|95.0|-0.44|0.63|||||Computed using linear regression, adjusted for propensity score comprised of preeclampsia and asthma.||
1762885|NCT00116272|3236672|Superiority or Other||Adjusted Difference|21.79|||||2-Sided|95.0|-83.32|126.91|||||Computed using linear regression, directly adjusted for asthma, RA2 severity score at 32 weeks, and disease severity score imputation indicator because propensity score adjustment was not balanced.||
1762886|NCT00116272|3236673|Superiority or Other||Adjusted Difference|-0.2|||||2-Sided|95.0|-0.65|0.26|||||Computed using linear regression, directly adjusted for referral source (not collapsed), vitamin use (not collapsed), preeclampsia, and asthma because propensity score adjustment was not balanced.||
1762887|NCT00116272|3236674|Superiority or Other||Hazard Ratio (HR)|1.6|||||2-Sided|95.0|0.86|2.98|||||Adjusted HR computed using Cox proportional hazards regression adjusted for preeclampsia||
1762888|NCT00116272|3236675|Superiority or Other||Hazard Ratio (HR)|0.47|||||2-Sided|95.0|0.2|1.12|||||Adjusted HR computed using Cox proportional hazards regression adjusted for propensity score comprised of referral source (3 categories: OTIS, Pharmaceutical Company/Sponsor/HCP, Patient Support Group/Internet/Other), and maternal height.||
1762889|NCT00116272|3236677|Superiority or Other||Odds Ratio (OR)|1.19|||||2-Sided|95.0|0.7|2.01|||||Unadjusted Odds Ratio computed using logistic regression. No adjusted estimate was computed due to no confirmed confounder.||
1762890|NCT00116272|3236678|Superiority or Other||Odds Ratio (OR)|2.37|||||2-Sided|95.0|1.02|5.52|||||Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height||
1762891|NCT00116272|3236679|Superiority or Other||Odds Ratio (OR)|2.77|||||2-Sided|95.0|1.04|7.35|||||Adjusted oddds ratio for major structural defects in women exposed to etanercept in their 1st trimester versus not exposed computed using logistic regression adjusted for propensity score comprised of asthma and maternal height||
1762892|NCT00116207|3236680|Superiority or Other|||||||0.83||||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH|
1762893|NCT00116207|3236681|Superiority or Other|||||||0.24||||||p values were computed using a general linear model adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH|
1762894|NCT00116207|3236682|Superiority or Other|||||||0.82||||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24 MONTH|
1762895|NCT00116207|3236682|Superiority or Other|||||||0.52||||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||BASELINE|
1762896|NCT00116207|3236683|Superiority or Other|||||||0.045||||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||24-MONTH|
1762897|NCT00116207|3236683|Superiority or Other|||||||0.32||||||p values were computed using a general linear model (ANOVA) adjusted at baseline for age, sex, HbA1c.|ANOVA|||BASELINE|
1762898|NCT00115934|3236698|Superiority or Other|||||||0.03|||||||Poisson regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.|||
1762899|NCT00115934|3236699|Superiority or Other|||||||0.002|||||||Poisson Regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.|||
1762900|NCT00115934|3236700|Superiority or Other|||||||0.2|||||||Poisson Regression|The offset parameter used in this analysis was the log of the number of patients per treatment arm.|||
1762901|NCT00115934|3236701|Superiority or Other|||||||0.003|||||||Poisson regression|The offset parameter used in the poisson regression was the log of the number of patients in each treatment arm.|||
1762902|NCT00115934|3236702|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1762903|NCT00115934|3236703|Superiority or Other|||||||0.54|||||||t-test, 2 sided||||
1762904|NCT00115934|3236704|Superiority or Other|||||||0.97|||||||t-test, 2 sided||||
1762905|NCT00115934|3236705|Superiority or Other|||||||0.07|||||||t-test, 2 sided||||
1762906|NCT00115934|3236706|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1762907|NCT00115934|3236707|Superiority or Other|||||||0.1|||||||Wilcoxon (Mann-Whitney)||||
1762908|NCT00115934|3236708|Superiority or Other|||||||0.004|||||||Wilcoxon (Mann-Whitney)|||Wilcoxon rank-sum test|
1762909|NCT00115934|3236709|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1762910|NCT00115934|3236710|Superiority or Other|||||||0.07|||||||Wilcoxon (Mann-Whitney)||||
1762911|NCT00115934|3236711|Superiority or Other|||||||0.009|||||||Wilcoxon (Mann-Whitney)||||
1762912|NCT00115934|3236712|Superiority or Other|||||||0.09|||||||Wilcoxon (Mann-Whitney)||||
1762913|NCT00115934|3236713|Superiority or Other|||||||0.06|||||||Log Rank||||
1762914|NCT00115934|3236714|Superiority or Other||Risk Difference (RD)|-10.1||||0.013||95.0|-17.8|-2.4|||Fisher Exact||The risk difference is defined as the percent of subjects with events in the RVPAS group minus the percent of subjects with events in the MBTS group.|The original sample size of 456 was based on 85% power, with a two-sided, two sample test of proportions (anticipating 28% MBTS subjects with events, 16% RVPAS subjects with events), and an alpha of 0.05. The critical p-value was 0.044 because four interim analyses were performed. The target trial size was increased from 466 to 554 to account for crossovers. The stopping boundary was crossed at the 4th interim look; however, the trial was not halted, because all subjects were enrolled.|
1762915|NCT00115765|3236734|Superiority or Other||Odds Ratio (OR)|0.68||||||95.0|0.28|1.67|||||||
1762916|NCT00115765|3236735|Superiority or Other||Odds Ratio (OR)|1.28||||||95.0|0.61|2.66|||||||
1762917|NCT00115765|3236736|Superiority or Other||Hazard Ratio (HR)|1.02||||||95.0|0.67|1.54|||||||
1762918|NCT00115765|3236737|Superiority or Other||Hazard Ratio (HR)|1.89||||||95.0|1.3|2.75|||||||
1762919|NCT00115765|3236738|Superiority or Other||Hazard Ratio (HR)|1.25||||||95.0|0.91|1.71|||||||
1762920|NCT00115765|3236739|Superiority or Other||Hazard Ratio (HR)|1.36||||||95.0|1.04|1.77|||||||
1762921|NCT00115765|3236741|Superiority or Other||Hazard Ratio (HR)|1.42||||0.257||95.0|0.77|2.62|||Regression, Cox|Model covariates were ECOG status, prior adjuvant chemotherapy, number of metastatic organs, and primary disease site|||
1762922|NCT00115765|3236742|Superiority or Other||Odds Ratio (OR)|1.11||||0.738||95.0|0.6|2.05|||Regression, Logistic|Model covariates were ECOG status, prior adjuvant chemotherapy, number of metastatic organs, and primary disease site|||
1762924|NCT00115765|3236747|Superiority or Other||Hazard Ratio (HR)|1.27||||0.011||95.0|1.06|1.52|||Regression, Cox|Model covariates were ECOG status, prior chemotherapy, metastatic organs, disease site, oxaliplatin dose < 85 mg/m2, and oxaliplatin dose > 100 mg/m2|||
1762925|NCT00115349|3236758|Superiority or Other|||||||0.89|||||||Mixed Models Analysis|Linear mixed models with treatment, time, and treatment x time interaction were used, allowing for random participant-specific intercepts and slopes.||The intended sample size of 86 patients (N=43 per arm) had 80% power to detect a 5% difference in LVEF between the two arms after 1 year of treatment, assuming a standard deviation of change in LVEF of 7.46%, and 20% loss to follow-up. The study was stopped early by NHLBI when analysis of the interim data confirmed a required sample size of 86 that was not achievable within the required time frame within the participating or planned centres.|
1762926|NCT00115063|3236762|Superiority or Other|||||||0.001|||||||t-test, 2 sided||||
1762927|NCT00115063|3236763|Superiority or Other|||||||0.16|||||||t-test, 2 sided||||
1762928|NCT00115063|3236764|Superiority or Other|||||||0.05||||||P-value for uric acid|t-test, 2 sided||||
1762929|NCT00115063|3236764|Superiority or Other|||||||0.42||||||P-value for triglycerides|t-test, 2 sided||||
1762930|NCT00115063|3236764|Superiority or Other|||||||0.01||||||P-value for HDL cholesterol|t-test, 2 sided||||
1762931|NCT00115063|3236764|Superiority or Other|||||||0.73||||||P-value for LDL cholesterol|t-test, 2 sided||||
1762932|NCT00115063|3236765|Superiority or Other|||||||0.6||||||P-value for dystolic blood pressure mean.|t-test, 2 sided||||
1762933|NCT00115063|3236765|Superiority or Other|||||||0.09||||||P-value for systolic blood pressure mean.|t-test, 2 sided||||
1762934|NCT00115063|3236766|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1762935|NCT00115063|3236767|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1762936|NCT00114777|3236808|Superiority or Other||Percentage difference|-8.5||||0.0616|2-Sided|97.3|-18.0|0.9|||Chi-squared||A continuity-corrected chi-squared test at the significance level 0.027 was performed to assess the effect of each belatacept regimen compared with cyclosporin A.||
1762937|NCT00114777|3236808|Superiority or Other||Percentage difference|-14.4||||0.0018|2-Sided|97.3|-24.0|-4.7|||Chi-squared||A continuity-corrected chi-squared test at the significance level 0.027 was performed to assess the effect of each belatacept regimen compared with cyclosporin A.||
1762938|NCT00114777|3236809|Superiority or Other||Treatment difference|3.2|||||2-Sided|97.3|-5.0|11.4|||||The treatment differences between each belatacept treatment group and cyclosporin group was tested at the 0.027 significance level for participant and graft survival (based on 10% non-inferiority margin).||
1762939|NCT00114777|3236809|Superiority or Other||Treament Difference|1.1|||||2-Sided|97.3|-7.2|9.4|||||The treatment differences between each belatacept treatment group and cyclosporin group was tested at the 0.027 significance level for participant and graft survival (based on 10% non-inferiority margin).||
1762940|NCT00114634|3236821|Superiority or Other|||||||1|||||||t-test, 2 sided||||
1762941|NCT00114530|3236824|Superiority||Person-Time (Years)|141.3|||||2-Sided||||||||The Person-Time (P-T) rate (events/P-T) is 0.80||
1762942|NCT00114530|3236824|Superiority||Person-Time (Years)|174.4|||||2-Sided||||||||The Person-Time (P-T) rate (events/P-T) is 0.76||
1762943|NCT00114530|3236824|Superiority|||||||0.7|||||||Regression, Linear|P-value comes from a Poisson regression comparing the person-year adjusted event rates between the two treatment groups.|||
1762944|NCT00114530|3236826|Superiority||Person-Time (Years)|141.3|||||2-Sided||||||||The Person-Time (P-T) rates (events/P-T) are as follows: Possibly related = 0.17, Probably related = 0.09, Definitely related = 0.04||
1762945|NCT00114530|3236826|Superiority||Person-Time (Years)|174.4|||||2-Sided||||||||The Person-Time (P-T) rates (events/P-T) are as follows: Possibly related = 0.61, Probably related = 0.57, Definitely related = 0.52||
1762946|NCT00114530|3236826|Superiority||||||<|0.001|||||||Regression, Linear|P-value comes from a Poisson regression comparing the person-year adjusted event rates between the two treatment groups.|||
1762947|NCT00114530|3236827|Superiority|||||||0.001|||||||Chi-squared||||
1762948|NCT00114530|3236828|Superiority|||||||0.002|||||||Chi-squared||||
1762949|NCT00114530|3236829|Superiority|||||||0.31|||||||Chi-squared||||
1762950|NCT00114530|3236830|Superiority|||||||0.3|||||||Chi-squared||||
1762951|NCT00114530|3236831|Superiority|||||||0.32|||||||Chi-squared||||
1762952|NCT00114530|3236832|Superiority|||||||0.71|||||||Chi-squared||||
1762953|NCT00114530|3236833|Superiority|||||||0.022|||||||Chi-squared||||
1762954|NCT00114530|3236834|Superiority|||||||0.026|||||||Chi-squared||||
1762955|NCT00114530|3236835|Superiority|||||||0.15|||||||Chi-squared|||Clinically significant pericardial effusion|
1762956|NCT00114530|3236835|Superiority|||||||0.042|||||||Chi-squared|||CHF requiring clinical treatment|
1762957|NCT00114530|3236835|Superiority|||||||0.46|||||||Chi-squared|||Development of new or worsening arrhythmias|
1762958|NCT00114530|3236836|Superiority|||||||0.51|||||||Chi-squared|||Clinically significant pericardial effusion|
1762959|NCT00114530|3236836|Superiority|||||||0.048|||||||Chi-squared|||CHF requiring clinical treatment|
1762960|NCT00114530|3236836|Superiority|||||||0.42|||||||Chi-squared|||Development of new or worsening arrhythmias|
1762961|NCT00114530|3236837|Superiority|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.|
1762962|NCT00114530|3236837|Superiority||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.|
1762963|NCT00114530|3236838|Superiority|||||||0.05|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.|
1762964|NCT00114530|3236838|Superiority|||||||0.002|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.|
1762965|NCT00114530|3236839|Superiority|||||||0.5|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.|
1762968|NCT00114530|3236840|Superiority|||||||0.02|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.|
1762969|NCT00114530|3236841|Superiority|||||||0.6|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.|
1762970|NCT00114530|3236841|Superiority|||||||0.1|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.|
1762971|NCT00114530|3236842|Superiority|||||||0.9|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.|
1762972|NCT00114530|3236842|Superiority|||||||0.08|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.|
1762973|NCT00114530|3236843|Superiority|||||||0.07|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Mental Component Score. This analysis is stratified by EFS status.|
1762974|NCT00114530|3236843|Superiority|||||||0.02|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Mental Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.|
1762975|NCT00114530|3236843|Superiority|||||||0.003|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Physical Component Score. This analysis is stratified by EFS status.|
1762976|NCT00114530|3236843|Superiority||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Physical Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.|
1762977|NCT00114530|3236844|Superiority|||||||0.1|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Mental Component Score. This analysis is stratified by EFS status.|
1762978|NCT00114530|3236844|Superiority|||||||0.05|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Mental Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.|
1762979|NCT00114530|3236844|Superiority|||||||0.02|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||Physical Component Score. This analysis is stratified by EFS status.|
1762980|NCT00114530|3236844|Superiority|||||||0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||Physical Component Score. This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.|
1762981|NCT00114530|3236845|Superiority|||||||0.002|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.|
1762982|NCT00114530|3236845|Superiority||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.|
1762983|NCT00114530|3236846|Superiority|||||||0.01|||||||Wilcoxon (Mann-Whitney)|Van Elteren extension of the Wilcoxon Rank Sum||This analysis is stratified by EFS status.|
1762984|NCT00114530|3236846|Superiority||||||<|0.001|||||||Kruskal-Wallis|Computed as Mantel Haenszel Chi Square using modified ridit scores.||This analysis is not stratified. EFS survivors and failures are pooled within each treatment arm.|
1762985|NCT00114530|3236847|Superiority|||||||0.19|||||||Fisher Exact||||
1762986|NCT00114530|3236848|Superiority|||||||0.28|||||||Fisher Exact||||
1762987|NCT00114530|3236849|Superiority|||||||0.02|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for overall survival through Month 72.|
1762988|NCT00114530|3236849|Superiority|||||||0.19|||||||Fisher Exact|||Treatment arm comparisons of overall survival at Month 54.|
1762989|NCT00114530|3236850|Superiority|||||||0.05|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for overall survival through Month 72.|
1762990|NCT00114530|3236850|Superiority|||||||0.28|||||||Fisher Exact|||Treatment arm comparisons of overall survival at Month 54.|
1762991|NCT00114530|3236851|Superiority|||||||0.49|||||||Fisher Exact||||
1762992|NCT00114530|3236852|Superiority|||||||0.48|||||||Fisher Exact||||
1762993|NCT00114530|3236853|Superiority|||||||0.49|||||||Fisher Exact||||
1762994|NCT00114530|3236854|Superiority|||||||0.48|||||||Fisher Exact||||
1762995|NCT00114530|3236855|Superiority|||||||0.021|||||||Fisher Exact||||
1762996|NCT00114530|3236856|Superiority|||||||0.059|||||||Fisher Exact||||
1762997|NCT00114530|3236857|Superiority|||||||0.03|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for EFS through Month 72|
1762998|NCT00114530|3236857|Superiority|||||||0.021|||||||Fisher Exact|||Treatment arm comparisons of EFS at Month 54.|
1762999|NCT00114530|3236858|Superiority|||||||0.06|||||||Log Rank|||Treatment arm comparisons of Kaplan-Meier curves for EFS through Month 72|
1763000|NCT00114530|3236858|Superiority|||||||0.059|||||||Fisher Exact|||Treatment arm comparisons of EFS at Month 54.|
1763001|NCT00114530|3236859|Superiority|||||||0.003|||||||Wilcoxon (Mann-Whitney)||||
1763002|NCT00114530|3236860|Superiority|||||||0.008|||||||Wilcoxon (Mann-Whitney)||||
1763003|NCT00114530|3236861|Superiority|||||||0.004|||||||Wilcoxon (Mann-Whitney)||||
1763004|NCT00114530|3236862|Superiority|||||||0.013||||||A Data and Safety Monitoring Board reviewed 4 pre-specified futility analyses that included an ability to stop for efficacy with p<0.0001, leaving alpha equal to 0.0496 for the primary ITT analysis of the GRCS at 54 months post-randomization.|Wilcoxon (Mann-Whitney)||||
1763005|NCT00114140|3236883|Superiority||Hazard Ratio (HR)|3.06||||0.0007|2-Sided|95.0|1.55|6.04||Two-sided significance level of 0.05|Log Rank||Reference level = Methylated|Progression-free survival|
1763006|NCT00114140|3236883|Superiority||Hazard Ratio (HR)|3.52||||0.0006|2-Sided|95.0|1.64|7.56||Two-sided significance level of 0.05|Log Rank||Reference level = Methylated|Overall survival: The sample size was increased to 135 to ensure adequate power to detect a hazard ratio (HR) of 2.5 for MGMT status, at a 2-sided significance level of 0.05 with an MGMT prevalence rate of at least 30%|
1763147|NCT00113529|3236960|Superiority or Other|||||||0.91|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1|
1763007|NCT00114140|3236885|Superiority or Other||||||<|0.001|||||||Z-test|||Assuming exponential distribution of survival times, the null hypothesis was a 43% increase in median survival time (40.5 mo. to 57.9 mo.) and a 21% increase in 3-year survival rate (54% to 65%). Assuming 5% ineligibility, 72 patients were required to be accrued over 3 years with 3-years of follow-up resulting in 80% power and 1-sided 0.10 significance level. (N later increased to 135 to accommodate an additional separate analysis of O-6-Methylguanine-DNA Methyltransferase (MGMT) status.)|
1763008|NCT00114127|3236886|Superiority or Other||||||<|0.292|||||||t-test, 2 sided||||
1763009|NCT00114127|3236887|Superiority or Other||||||<|0.132|||||||t-test, 2 sided||||
1763010|NCT00114101|3236893|Superiority or Other (legacy)||Hazard Ratio (HR)|0.53|||<|0.001|2-Sided|95.0|0.41|0.69|||Fisher Exact||||
1763011|NCT00114101|3236894|Superiority or Other (legacy)||Hazard Ratio (HR)|0.52||||0.7|2-Sided|95.0|0.26|1.02|||Log Rank||||
1763012|NCT00114101|3236896|Non-Inferiority or Equivalence (legacy)|This study was designed to have 80% power, with the use of the log-rank test at a one-sided significance level of 0.05, to detect a hazard ratio of 1.4, assuming proportional hazards and an exponential time to event distribution. Under the assumed framework, 309 events were expected. The expected drop out rate before randomization was 15%.|Hazard Ratio (HR)|0.36|||<|0.001|2-Sided|95.0|0.26|0.53||Participants were randomized with the use of a permuted-block design stratified by beta 2 microglobulin, prior use of thalidomide and prior use of lenalidomide. TTP was monitored with the use of a group sequential design for superiority and futility.|Log Rank||||
1763013|NCT00113880|3236900|Superiority or Other||Hazard Ratio (HR)|0.31||||0.01|2-Sided|95.0|0.17|0.54||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.|
1763014|NCT00113880|3236900|Superiority or Other||Hazard Ratio (HR)|0.47||||0.01|2-Sided|95.0|0.32|0.69||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.|
1763015|NCT00113880|3236901|Superiority or Other||Hazard Ratio (HR)|0.46||||0.01|2-Sided|95.0|0.25|0.85||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763016|NCT00113880|3236901|Superiority or Other||Hazard Ratio (HR)|0.43||||0.01|2-Sided|95.0|0.33|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763017|NCT00113880|3236901|Superiority or Other||Hazard Ratio (HR)|0.49||||0.01|2-Sided|95.0|0.35|0.67||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763018|NCT00113880|3236901|Superiority or Other||Hazard Ratio (HR)|0.45||||0.01||95.0|0.37|0.55||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763019|NCT00113880|3236901|Superiority or Other||Hazard Ratio (HR)|0.29||||0.02|2-Sided|95.0|0.26|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763020|NCT00113880|3236901|Superiority or Other||Hazard Ratio (HR)|0.42||||0.01|2-Sided|95.0|0.31|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763021|NCT00113880|3236901|Superiority or Other||Hazard Ratio (HR)|0.37||||0.01|2-Sided|95.0|0.26|0.55||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763022|NCT00113880|3236901|Superiority or Other||Hazard Ratio (HR)|0.41||||0.01|2-Sided|95.0|0.33|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763066|NCT00113880|3236911|Superiority or Other||Risk Ratio (RR)|0.42||||0.01|2-Sided|95.0|0.38|0.47||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763023|NCT00113880|3236902|Superiority or Other||Hazard Ratio (HR)|0.69||||0.01|2-Sided|95.0|0.52|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763024|NCT00113880|3236902|Superiority or Other||Hazard Ratio (HR)|0.75||||0.01|2-Sided|95.0|0.61|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763025|NCT00113880|3236902|Superiority or Other||Hazard Ratio (HR)|0.67||||0.01|2-Sided|95.0|0.49|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17 years, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763026|NCT00113880|3236902|Superiority or Other||Hazard Ratio (HR)|0.72||||0.01|2-Sided|95.0|0.58|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763027|NCT00113880|3236903|Superiority or Other||Risk Ratio (RR)|0.0||||0.03|2-Sided|95.0|0.0|0.82|||Fisher Exact||Population: 18-49, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763028|NCT00113880|3236903|Superiority or Other||Hazard Ratio (HR)|0.33||||0.01|2-Sided|95.0|0.16|0.68||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763029|NCT00113880|3236903|Superiority or Other||Hazard Ratio (HR)|0.36||||0.01|2-Sided|95.0|0.22|0.61||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763030|NCT00113880|3236903|Superiority or Other||Hazard Ratio (HR)|0.73||||0.01|2-Sided|95.0|0.57|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any acute respiratory tract event rates were presented per 1,000 person-months.|
1763031|NCT00113880|3236903|Superiority or Other||Hazard Ratio (HR)|0.83||||0.02|2-Sided|95.0|0.71|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any acute respiratory tract event rates were presented per 1,000 person-months.|
1763032|NCT00113880|3236903|Superiority or Other||Hazard Ratio (HR)|0.36||||0.04|2-Sided|95.0|0.14|0.93||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Pharyngitis event rates were presented per 1,000 person-months.|
1763033|NCT00113880|3236903|Superiority or Other||Hazard Ratio (HR)|0.74||||0.04|2-Sided|95.0|0.55|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Pharyngitis event rates were presented per 1,000 person-months.|
1763034|NCT00113880|3236903|Superiority or Other||Hazard Ratio (HR)|0.31||||0.01|2-Sided|95.0|0.13|0.74||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 9-17, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763035|NCT00113880|3236903|Superiority or Other||Hazard Ratio (HR)|0.33||||0.03|2-Sided|95.0|0.12|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 5-8, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763036|NCT00113880|3236903|Superiority or Other||Hazard Ratio (HR)|0.3||||0.01|2-Sided|95.0|0.15|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763037|NCT00113880|3236904|Superiority or Other|||||||0.02||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Exact method or Cox model|||Irritable bowel syndrome event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.|
1763038|NCT00113880|3236904|Superiority or Other||Hazard Ratio (HR)|1.95||||0.02|2-Sided|95.0|1.14|3.34||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Sinusitis event rates were presented per 1,000 person-months.|
1763039|NCT00113880|3236905|Superiority or Other||Hazard Ratio (HR)|0.41||||0.01||95.0|0.21|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.|
1763040|NCT00113880|3236905|Superiority or Other||Risk Ratio (RR)|0.69||||0.03|2-Sided|95.0|0.5|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.|
1763041|NCT00113880|3236905|Superiority or Other||Risk Ratio (RR)|0.78||||0.02|2-Sided|95.0|0.63|0.96||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any acute resp. tract event rates were presented per 1,000 person-months.|
1763042|NCT00113880|3236905|Superiority or Other||Hazard Ratio (HR)|0.29||||0.02|2-Sided|95.0|0.1|0.78||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.|
1763043|NCT00113880|3236905|Superiority or Other||Risk Ratio (RR)|0.49||||0.01|2-Sided|95.0|0.28|0.84||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.|
1763044|NCT00113880|3236905|Superiority or Other||Hazard Ratio (HR)|0.6||||0.02|2-Sided|95.0|0.4|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|URI event rates were presented per 1,000 person-months.|
1763045|NCT00113880|3236905|Superiority or Other||Hazard Ratio (HR)|0.16||||0.04|2-Sided|95.0|0.03|0.93||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Sinusitis event rates were presented per 1,000 person-months.|
1763046|NCT00113880|3236906|Superiority or Other||Hazard Ratio (HR)|0.16||||0.01|2-Sided|95.0|0.13|0.18||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.|
1763047|NCT00113880|3236906|Superiority or Other||Hazard Ratio (HR)|0.29||||0.01|2-Sided|95.0|0.26|0.33||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.|
1763048|NCT00113880|3236907|Superiority or Other||Hazard Ratio (HR)|0.43||||0.01|2-Sided|95.0|0.36|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.|
1763049|NCT00113880|3236907|Superiority or Other||Hazard Ratio (HR)|0.64||||0.01|2-Sided|95.0|0.57|0.73||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 180 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Hospitalization or death event rates were presented per 1,000 person-months.|
1763050|NCT00113880|3236908|Superiority or Other||Hazard Ratio (HR)|0.33||||0.01|2-Sided|95.0|0.23|0.48||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 yrs, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.|
1763051|NCT00113880|3236908|Superiority or Other||Hazard Ratio (HR)|0.6||||0.01|2-Sided|95.0|0.47|0.77||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.|
1763148|NCT00113529|3236961|Superiority or Other|||||||0.121|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28|
1763052|NCT00113880|3236908|Superiority or Other||Hazard Ratio (HR)|0.34||||0.01|2-Sided|95.0|0.21|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.|
1763053|NCT00113880|3236908|Superiority or Other||Hazard Ratio (HR)|0.65||||0.01|2-Sided|95.0|0.47|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.|
1763054|NCT00113880|3236909|Superiority or Other||Hazard Ratio (HR)|0.33||||0.01|2-Sided|95.0|0.23|0.48||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: 18-49 yrs, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.|
1763055|NCT00113880|3236909|Superiority or Other||Hazard Ratio (HR)|0.6||||0.01|2-Sided|95.0|0.47|0.77||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.|
1763056|NCT00113880|3236909|Superiority or Other||Hazard Ratio (HR)|0.34||||0.01|2-Sided|95.0|0.21|0.57||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox||Population: 18-49 yrs, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.|
1763057|NCT00113880|3236909|Superiority or Other||Hazard Ratio (HR)|0.65||||0.01|2-Sided|95.0|0.47|0.91||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Regression, Cox||Population: all ages, within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|SAE event rates were presented per 1,000 person-months.|
1763058|NCT00113880|3236910|Superiority or Other||Risk Ratio (RR)|0.0||||0.04|2-Sided|95.0|0.0|0.82||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Encephalitis/encephalopathy event rates were presented per 1,000 person-months.|
1763059|NCT00113880|3236911|Superiority or Other||Risk Ratio (RR)|0.47||||0.01|2-Sided|95.0|0.27|0.78||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.|
1763060|NCT00113880|3236911|Superiority or Other||Risk Ratio (RR)|0.72||||0.01|2-Sided|95.0|0.58|0.88||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.|
1763061|NCT00113880|3236911|Superiority or Other||Risk Ratio (RR)|0.83||||0.02|2-Sided|95.0|0.7|0.97||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.|
1763062|NCT00113880|3236911|Superiority or Other||Risk Ratio (RR)|0.75||||0.01|2-Sided|95.0|0.66|0.85||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Wheezing/SOB event rates were presented per 1,000 person-months.|
1763063|NCT00113880|3236911|Superiority or Other||Risk Difference (RD)|0.28||||0.01|2-Sided|95.0|0.15|0.52||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/Rad event rates were presented per 1,000 person-months.|
1763064|NCT00113880|3236911|Superiority or Other||Risk Ratio (RR)|0.58||||0.05|2-Sided|95.0|0.49|0.68||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763065|NCT00113880|3236911|Superiority or Other||Risk Ratio (RR)|0.37||||0.01|2-Sided|95.0|0.34|0.41||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763097|NCT00113880|3236917|Superiority or Other||Hazard Ratio (HR)|0.05||||0.03|2-Sided|95.0|0.0|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.|
1763067|NCT00113880|3236911|Superiority or Other||Risk Ratio (RR)|0.42||||0.01|2-Sided|95.0|0.39|0.45||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Asthma/RAD event rates event rates were presented per 1,000 person-months.|
1763068|NCT00113880|3236911|Superiority or Other||Risk Ratio (RR)|0.51||||0.01|2-Sided|95.0|0.33|0.76||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763069|NCT00113880|3236911|Superiority or Other||Risk Ratio (RR)|0.57||||0.01|2-Sided|95.0|0.49|0.67||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763070|NCT00113880|3236911|Superiority or Other||Risk Ratio (RR)|0.42||||0.01|2-Sided|95.0|0.38|0.46||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763071|NCT00113880|3236911|Superiority or Other||Risk Ratio (RR)|0.51||||0.01|2-Sided|95.0|0.47|0.56||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months|
1763072|NCT00113880|3236911|Superiority or Other||Risk Ratio (RR)|0.48||||0.01|2-Sided|95.0|0.45|0.51||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763073|NCT00113880|3236912|Superiority or Other||Risk Ratio (RR)|0.49||||0.01|2-Sided|95.0|0.29|0.79||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8yrs, within 180 days, PD2. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763074|NCT00113880|3236912|Superiority or Other||Risk Ratio (RR)|0.79||||0.01|2-Sided|95.0|0.7|0.88||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763075|NCT00113880|3236912|Superiority or Other||Risk Ratio (RR)|0.87||||0.01|2-Sided|95.0|0.81|0.94||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: All ages, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Asthma/RAD event rates were presented per 1,000 person-months.|
1763076|NCT00113880|3236912|Superiority or Other||Risk Ratio (RR)|0.83||||0.01|2-Sided|95.0|0.75|0.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 yrs., within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months|
1763077|NCT00113880|3236912|Superiority or Other||Risk Ratio (RR)|0.92||||0.01|2-Sided|95.0|0.86|0.98||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined, within 180 days, PD1. The rate of events in FluMist recipients represents the numerator; the rate of events in the unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763078|NCT00113880|3236913|Superiority or Other||Risk Ratio (RR)|0.47||||0.05|2-Sided|95.0|0.21|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years, PD2 within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763079|NCT00113880|3236913|Superiority or Other||Risk Ratio (RR)|0.41||||0.01|2-Sided|95.0|0.27|0.6||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763080|NCT00113880|3236913|Superiority or Other||Risk Ratio (RR)|0.36||||0.01|2-Sided|95.0|0.28|0.45||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763139|NCT00113529|3236959|Superiority or Other|||||||1|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763140|NCT00113529|3236959|Superiority or Other|||||||0.075|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763081|NCT00113880|3236913|Superiority or Other||Risk Ratio (RR)|0.4||||0.01|2-Sided|95.0|0.32|0.5||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763082|NCT00113880|3236913|Superiority or Other||Risk Ratio (RR)|0.38||||0.01|2-Sided|95.0|0.33|0.44||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763083|NCT00113880|3236913|Superiority or Other||Risk Ratio (RR)|0.42||||0.01|2-Sided|95.0|0.23|0.75||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763084|NCT00113880|3236913|Superiority or Other||Risk Ratio (RR)|0.34||||0.01|2-Sided|95.0|0.24|0.47||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 9-17 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763085|NCT00113880|3236913|Superiority or Other||Risk Ratio (RR)|0.3||||0.01|2-Sided|95.0|0.22|0.42||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months|
1763086|NCT00113880|3236913|Superiority or Other||Risk Ratio (RR)|0.33||||0.01|2-Sided|95.0|0.27|0.41||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 21 days. The rate of events in FluMist recipients represents the numerator; the rate of events in the TIV controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763087|NCT00113880|3236914|Superiority or Other||Risk Ratio (RR)|0.68||||0.04|2-Sided|95.0|0.46|0.99||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 18-49 years within 42 days. The rate of events in FluMist recipients represents the numerator; the rate of events in unvaccinated controls represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763088|NCT00113880|3236914|Superiority or Other||Risk Ratio (RR)|0.59||||0.01|2-Sided|95.0|0.41|0.83||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: 5-8 years within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763089|NCT00113880|3236914|Superiority or Other||Risk Ratio (RR)|0.71||||0.01|2-Sided|95.0|0.56|0.89||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Fisher Exact||Population: all ages combined within 21 days. The rate of events during the risk period represents the numerator; the rate of events during the control period represents the denominator.|Any asthma or wheezing event rates were presented per 1,000 person-months.|
1763090|NCT00113880|3236916|Superiority or Other||Hazard Ratio (HR)|2.06||||0.04|2-Sided|95.0|1.02|4.13||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Urticaria event rates were presented per 1,000 person-months.|
1763091|NCT00113880|3236917|Superiority or Other||Hazard Ratio (HR)|0.02||||0.01|2-Sided|95.0|0.01|0.03|||Regression, Cox||Population was the 18-49 year age and all ages combined groups.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.|
1763092|NCT00113880|3236917|Superiority or Other||Hazard Ratio (HR)|0.05||||0.01|2-Sided|95.0|0.03|0.08||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the 18-49 year age and the all ages combined groups.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.|
1763093|NCT00113880|3236917|Superiority or Other||Hazard Ratio (HR)|0.4||||0.01|2-Sided|95.0|0.22|0.74||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the all ages combined group.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.|
1763094|NCT00113880|3236917|Superiority or Other||Hazard Ratio (HR)|0.37||||0.01|2-Sided|95.0|0.2|0.7||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox||Population was the 18-49 year age group.|Pregnancy exam/supervision event rates were presented per 1,000 person-months.|
1763095|NCT00113880|3236917|Superiority or Other||Hazard Ratio (HR)|0.11||||0.04|2-Sided|95.0|0.01|0.86||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.|
1763096|NCT00113880|3236917|Superiority or Other||Hazard Ratio (HR)|0.13||||0.05|2-Sided|95.0|0.02|1.0||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Regression, Cox|||Heart murmur event rates were presented per 1,000 person-months.|
1763141|NCT00113529|3236959|Superiority or Other|||||||0.428|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1|
1763142|NCT00113529|3236960|Superiority or Other|||||||0.582|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28|
1763098|NCT00113880|3236918|Superiority or Other||Hazard Ratio (HR)|7.17||||0.01|2-Sided|95.0|2.13|24.13||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.|
1763099|NCT00113880|3236918|Superiority or Other||Hazard Ratio (HR)|7.35||||0.01|2-Sided|95.0|2.2|24.54||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.|
1763100|NCT00113880|3236918|Superiority or Other||Hazard Ratio (HR)|1.59||||0.02|2-Sided|95.0|0.64|3.92||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Regression, Cox|||Mastitis event rates were presented per 1,000 person-months.|
1763101|NCT00113880|3236918|Superiority or Other|||||||0.02||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment.|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.|
1763102|NCT00113880|3236918|Superiority or Other|||||||0.01||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple CIs were constructed without multiplicity adjustment|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the RR or HR is not estimable.|
1763103|NCT00113880|3236918|Superiority or Other|||||||0.01||||||Due to the exploratory nature of the study and the lack of formal hypothesis testing, multiple confidence intervals (CIs) were constructed without multiplicity adjustment.|Exact method or Cox model|||Breast lump/cyst event rates were presented per 1,000 person-months. If the control group has no event, the relative risk (RR) or hazard ratio (HR) is not estimable.|
1763104|NCT00113841|3236919|Superiority or Other|||||||0.16|||||||t-test, 2 sided||||
1763105|NCT00113763|3236928|Superiority or Other|||||||0.806||||||This analysis was conducted contingent on a statistically significant difference in the primary outcome, and adjusted to an a priori threshold for statistical significance at a 4% level for a multiple comparison involving objective tumor response|Log Rank|Stratified by baseline IVRS ECOG performance status and geographic region||Null hypothesis was no difference between treatment groups|
1763106|NCT00113763|3236929|Superiority or Other||||||<|0.0001|||||||Log Rank|Stratified by baseline IVRS ECOG performance status and geographic region||Null hypothesis was no difference between treatment groups|
1763107|NCT00113607|3236932|Superiority or Other||Hazard Ratio, log|0.95||||0.8203|2-Sided|95.0|0.62|1.46|||Log Rank||||
1763108|NCT00113607|3236933|Superiority or Other||Odds Ratio (OR)|1.646||||0.008|2-Sided|95.0|1.144|2.367|||Fisher Exact||||
1763109|NCT00113607|3236934|Superiority or Other||Hazard Ratio, log|0.86||||0.0835|2-Sided|95.0|0.72|1.02|||Log Rank||||
1763110|NCT00113607|3236935|Superiority or Other||Hazard Ratio, log|0.79||||0.019|2-Sided|95.0|0.65|0.96|||Log Rank||||
1763111|NCT00113555|3236951|Superiority||Mean Difference (Net)|-1.16|Standard Deviation|1.05|<|0.001|2-Sided|95.0|-1.325|-1.003|||Wilcoxon (Mann-Whitney)|||Wilcoxon’s matched pairs signed ranks test was used to determine the significance of differences between scores at follow-up compared to pre-implant.|
1763112|NCT00113529|3236955|Superiority or Other|||||||0.055|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28|
1763113|NCT00113529|3236955|Superiority or Other|||||||0.124|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763114|NCT00113529|3236955|Superiority or Other|||||||0.019|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763115|NCT00113529|3236955|Superiority or Other|||||||1|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763116|NCT00113529|3236955|Superiority or Other|||||||0.075|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763117|NCT00113529|3236955|Superiority or Other|||||||0.428|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1|
1763118|NCT00113529|3236956|Superiority or Other|||||||0.582|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28|
1763119|NCT00113529|3236956|Superiority or Other|||||||0.883|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763120|NCT00113529|3236956|Superiority or Other|||||||0.509|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763121|NCT00113529|3236956|Superiority or Other|||||||1|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763122|NCT00113529|3236956|Superiority or Other|||||||0.02|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763123|NCT00113529|3236956|Superiority or Other|||||||0.91|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1|
1763124|NCT00113529|3236957|Superiority or Other|||||||0.121|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28|
1763125|NCT00113529|3236957|Superiority or Other|||||||0.608|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763126|NCT00113529|3236957|Superiority or Other|||||||0.51|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763127|NCT00113529|3236957|Superiority or Other|||||||0.423|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763128|NCT00113529|3236957|Superiority or Other|||||||0.462|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763129|NCT00113529|3236957|Superiority or Other|||||||0.734|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1|
1763130|NCT00113529|3236958|Superiority or Other|||||||0.121|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28|
1763131|NCT00113529|3236958|Superiority or Other|||||||0.164|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763132|NCT00113529|3236958|Superiority or Other|||||||0.067|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763133|NCT00113529|3236958|Superiority or Other|||||||0.23|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763134|NCT00113529|3236958|Superiority or Other|||||||0.854|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763135|NCT00113529|3236958|Superiority or Other|||||||0.734|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1|
1763136|NCT00113529|3236959|Superiority or Other|||||||0.055|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28|
1763137|NCT00113529|3236959|Superiority or Other|||||||0.124|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763138|NCT00113529|3236959|Superiority or Other|||||||0.019|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763149|NCT00113529|3236961|Superiority or Other|||||||0.608|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763150|NCT00113529|3236961|Superiority or Other|||||||0.51|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763151|NCT00113529|3236961|Superiority or Other|||||||0.423|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763152|NCT00113529|3236961|Superiority or Other|||||||0.462|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763153|NCT00113529|3236961|Superiority or Other|||||||0.734|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1|
1763154|NCT00113529|3236962|Superiority or Other|||||||0.121|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28|
1763155|NCT00113529|3236962|Superiority or Other|||||||0.164|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763156|NCT00113529|3236962|Superiority or Other|||||||0.067|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763157|NCT00113529|3236962|Superiority or Other|||||||0.23|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763158|NCT00113529|3236962|Superiority or Other|||||||0.854|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763159|NCT00113529|3236962|Superiority or Other|||||||0.734|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1|
1763160|NCT00113529|3236963|Superiority or Other|||||||0.046|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763161|NCT00113529|3236963|Superiority or Other|||||||0.14|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763162|NCT00113529|3236963|Superiority or Other|||||||0.645|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763163|NCT00113529|3236963|Superiority or Other|||||||0.722|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763164|NCT00113529|3236963|Superiority or Other|||||||0.435|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1|
1763165|NCT00113529|3236964|Superiority or Other|||||||1|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763166|NCT00113529|3236964|Superiority or Other|||||||1|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763167|NCT00113529|3236964|Superiority or Other|||||||0.029|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763168|NCT00113529|3236964|Superiority or Other|||||||0.227|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763169|NCT00113529|3236964|Superiority or Other|||||||0.275|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1|
1763170|NCT00113529|3236965|Superiority or Other|||||||0.278|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763171|NCT00113529|3236965|Superiority or Other|||||||0.956|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763172|NCT00113529|3236965|Superiority or Other|||||||0.277|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763173|NCT00113529|3236965|Superiority or Other|||||||0.286|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763174|NCT00113529|3236965|Superiority or Other|||||||0.473|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1|
1763175|NCT00113529|3236966|Superiority or Other|||||||0.332|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763176|NCT00113529|3236966|Superiority or Other|||||||1|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763177|NCT00113529|3236966|Superiority or Other|||||||0.834|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763178|NCT00113529|3236966|Superiority or Other|||||||0.749|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763179|NCT00113529|3236966|Superiority or Other|||||||0.075|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 1|
1763180|NCT00113529|3236975|Superiority or Other||probability|82.4||||||95.0|64.9|91.7|||||||
1763181|NCT00113529|3236981|Superiority or Other||Objective Response Rate (ORR) (percent)|37.1||||||95.0|21.5|55.1|||||ORR=proportion of subjects with confirmed CR or PR, relative to total subjects who received at least 1 dose of study medication, had a baseline disease assessment, and had the correct histological cancer type.||
1763182|NCT00113516|3236986|Superiority or Other||Hazard Ratio (HR)|0.7||||0.8084|2-Sided|95.0|0.04|11.79|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 5, Day 28|
1763183|NCT00113516|3236986|Superiority or Other||Hazard Ratio (HR)|5.4||||0.0943|2-Sided|95.0|0.59|48.81|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 28|
1763184|NCT00113516|3236986|Superiority or Other||Hazard Ratio (HR)|4.4||||0.0241|2-Sided|95.0|1.09|17.56|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 1|
1763185|NCT00113516|3236986|Superiority or Other||Hazard Ratio (HR)|0.6||||0.2787|2-Sided|95.0|0.22|1.55|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 28|
1763186|NCT00113516|3236986|Superiority or Other||Hazard Ratio (HR)|1.6||||0.2726|2-Sided|95.0|0.69|3.7|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 1|
1763187|NCT00113516|3236986|Superiority or Other||Hazard Ratio (HR)|1.5||||0.2682|2-Sided|95.0|0.72|3.23|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 28|
1763188|NCT00113516|3236986|Superiority or Other||Hazard Ratio (HR)|0.9||||0.766|2-Sided|95.0|0.51|1.65|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 1|
1763189|NCT00113516|3236987|Superiority or Other||Hazard Ratio (HR)|0.6||||0.6949|2-Sided|95.0|0.05|7.0|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 5, Day 28|
1763190|NCT00113516|3236987|Superiority or Other||Hazard Ratio (HR)|0.3||||0.0522|2-Sided|95.0|0.06|1.11|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 28|
1763191|NCT00113516|3236987|Superiority or Other||Hazard Ratio (HR)|0.7||||0.4297|2-Sided|95.0|0.24|1.85|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 1|
1763192|NCT00113516|3236987|Superiority or Other||Hazard Ratio (HR)|0.6||||0.221|2-Sided|95.0|0.26|1.38|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 28|
1763193|NCT00113516|3236987|Superiority or Other||Hazard Ratio (HR)|0.9||||0.8195|2-Sided|95.0|0.44|1.91|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 1|
1763194|NCT00113516|3236987|Superiority or Other||Hazard Ratio (HR)|1.0||||0.929|2-Sided|95.0|0.51|1.86|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 28|
1763195|NCT00113516|3236987|Superiority or Other||Hazard Ratio (HR)|1.3||||0.4269|2-Sided|95.0|0.72|2.21|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 1|
1763196|NCT00113516|3236988|Superiority or Other||Hazard Ratio (HR)|2.6||||0.4328|2-Sided|95.0|0.23|29.12|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 5, Day 28|
1763197|NCT00113516|3236988|Superiority or Other||Hazard Ratio (HR)|0.3||||0.1637|2-Sided|95.0|0.06|1.7|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 28|
1763198|NCT00113516|3236988|Superiority or Other||Hazard Ratio (HR)|3.8||||0.0074|2-Sided|95.0|1.35|10.88|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 1|
1763199|NCT00113516|3236988|Superiority or Other||Hazard Ratio (HR)|0.8||||0.5681|2-Sided|95.0|0.33|1.85|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 28|
1763200|NCT00113516|3236988|Superiority or Other||Hazard Ratio (HR)|1.1||||0.8957|2-Sided|95.0|0.5|2.18|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 1|
1763201|NCT00113516|3236988|Superiority or Other||Hazard Ratio (HR)|1.6||||0.1484|2-Sided|95.0|0.84|3.13|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 28|
1763202|NCT00113516|3236988|Superiority or Other||Hazard Ratio (HR)|1.2||||0.4768|2-Sided|95.0|0.7|2.17|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 1|
1763203|NCT00113516|3236989|Superiority or Other||Hazard Ratio (HR)|3.3||||0.32|2-Sided|95.0|0.28|38.48|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 28|
1763204|NCT00113516|3236989|Superiority or Other||Hazard Ratio (HR)|1.9||||0.3411|2-Sided|95.0|0.5|7.15|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 1|
1763205|NCT00113516|3236989|Superiority or Other||Hazard Ratio (HR)|0.4||||0.0712|2-Sided|95.0|0.13|1.13|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 28|
1763206|NCT00113516|3236989|Superiority or Other||Hazard Ratio (HR)|1.3||||0.6028|2-Sided|95.0|0.49|3.37|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 1|
1763207|NCT00113516|3236989|Superiority or Other||Hazard Ratio (HR)|1.2||||0.6854|2-Sided|95.0|0.49|3.0|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 28|
1763208|NCT00113516|3236989|Superiority or Other||Hazard Ratio (HR)|0.8||||0.6682|2-Sided|95.0|0.39|1.84|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 1|
1763209|NCT00113516|3236990|Superiority or Other||Hazard Ratio (HR)|1.7||||0.4637|2-Sided|95.0|0.38|8.12|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 28|
1763210|NCT00113516|3236990|Superiority or Other||Hazard Ratio (HR)|1.4||||0.5627|2-Sided|95.0|0.46|4.18|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 1|
1763211|NCT00113516|3236990|Superiority or Other||Hazard Ratio (HR)|0.3||||0.0109|2-Sided|95.0|0.12|0.8|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 28|
1763212|NCT00113516|3236990|Superiority or Other||Hazard Ratio (HR)|0.9||||0.8766|2-Sided|95.0|0.42|2.11|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 1|
1763213|NCT00113516|3236990|Superiority or Other||Hazard Ratio (HR)|1.6||||0.2504|2-Sided|95.0|0.72|3.49|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 28|
1763214|NCT00113516|3236990|Superiority or Other||Hazard Ratio (HR)|1.3||||0.5215|2-Sided|95.0|0.62|2.53|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 1|
1763215|NCT00113516|3236991|Superiority or Other||Hazard Ratio (HR)|1.4||||0.8084|2-Sided|95.0|0.08|23.57|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 5, Day 28|
1763216|NCT00113516|3236991|Superiority or Other||Hazard Ratio (HR)|2.7||||0.2085|2-Sided|95.0|0.52|14.37|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 28|
1763217|NCT00113516|3236991|Superiority or Other||Hazard Ratio (HR)|4.2||||0.011|2-Sided|95.0|1.26|13.85|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 1|
1763218|NCT00113516|3236991|Superiority or Other||Hazard Ratio (HR)|1.4||||0.4809|2-Sided|95.0|0.56|3.39|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 28|
1763219|NCT00113516|3236991|Superiority or Other||Hazard Ratio (HR)|1.9||||0.1093|2-Sided|95.0|0.85|4.3|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 1|
1763220|NCT00113516|3236991|Superiority or Other||Hazard Ratio (HR)|1.6||||0.1918|2-Sided|95.0|0.77|3.47|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 28|
1763221|NCT00113516|3236991|Superiority or Other||Hazard Ratio (HR)|1.1||||0.7824|2-Sided|95.0|0.56|2.17|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 1|
1763222|NCT00113516|3236992|Superiority or Other||Hazard Ratio (HR)|3.3||||0.32|2-Sided|95.0|0.28|38.48|||Log Rank||HR was based upon the ratio of >=Median Cutpoint group hazard to <Median Cutpoint group.|Cycle 3, Day 28|
1763223|NCT00113516|3236992|Superiority or Other||Hazard Ratio (HR)|2.0||||0.2948|2-Sided|95.0|0.54|7.07|||Log Rank||HR was based upon the ratio of >=Median Cutpoint group hazard to <Median Cutpoint group.|Cycle 3, Day 1|
1764484|NCT00095498|3239348|Superiority or Other||||||<|0.001|||||||van Elteren Stratified Rank Test||||
1763224|NCT00113516|3236992|Superiority or Other||Hazard Ratio (HR)|0.4||||0.0712|2-Sided|95.0|0.13|1.13|||Log Rank||HR was based upon the ratio of >=Median Cutpoint group hazard to <Median Cutpoint group.|Cycle 2, Day 28|
1763225|NCT00113516|3236992|Superiority or Other||Hazard Ratio (HR)|1.3||||0.5337|2-Sided|95.0|0.52|3.44|||Log Rank||HR was based upon the ratio of >=Median Cutpoint group hazard to <Median Cutpoint group.|Cycle 2, Day 1|
1763226|NCT00113516|3236992|Superiority or Other||Hazard Ratio (HR)|1.4||||0.466|2-Sided|95.0|0.58|3.29|||Log Rank||HR was based upon the ratio of >=Median Cutpoint group hazard to <Median Cutpoint group.|Cycle 1, Day 28|
1763227|NCT00113516|3236992|Superiority or Other||Hazard Ratio (HR)|0.8||||0.5277|2-Sided|95.0|0.39|1.62|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 1|
1763228|NCT00113516|3236993|Superiority or Other||Hazard Ratio (HR)|1.7||||0.4637|2-Sided|95.0|0.38|8.12|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 28|
1763229|NCT00113516|3236993|Superiority or Other||Hazard Ratio (HR)|1.2||||0.6878|2-Sided|95.0|0.43|3.58|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 3, Day 1|
1763230|NCT00113516|3236993|Superiority or Other||Hazard Ratio (HR)|0.3||||0.0109|2-Sided|95.0|0.12|0.8|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 28|
1763231|NCT00113516|3236993|Superiority or Other||Hazard Ratio (HR)|0.9||||0.7599|2-Sided|95.0|0.4|1.95|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 1|
1763232|NCT00113516|3236993|Superiority or Other||Hazard Ratio (HR)|1.3||||0.4474|2-Sided|95.0|0.63|2.82|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 28|
1763233|NCT00113516|3236993|Superiority or Other||Hazard Ratio (HR)|1.2||||0.507|2-Sided|95.0|0.65|2.39|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 1|
1763234|NCT00113516|3236994|Superiority or Other||Hazard Ratio (HR)|1.4||||0.8084|2-Sided|95.0|0.08|23.57|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group|Cycle 5, Day 28|
1763235|NCT00113516|3236994|Superiority or Other||Hazard Ratio (HR)|2.7||||0.2085|2-Sided|95.0|0.52|14.37|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group|Cycle 3, Day 28|
1763236|NCT00113516|3236994|Superiority or Other||Hazard Ratio (HR)|3.6||||0.0153|2-Sided|95.0|1.19|11.13|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group|Cycle 3, Day 1|
1763237|NCT00113516|3236994|Superiority or Other||Hazard Ratio (HR)|1.4||||0.4809|2-Sided|95.0|0.56|3.39|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 28|
1763238|NCT00113516|3236994|Superiority or Other||Hazard Ratio (HR)|1.8||||0.1344|2-Sided|95.0|0.82|3.98|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 2, Day 1|
1763239|NCT00113516|3236994|Superiority or Other||Hazard Ratio (HR)|1.6||||0.198|2-Sided|95.0|0.77|3.3|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 28|
1763240|NCT00113516|3236994|Superiority or Other||Hazard Ratio (HR)|1.1||||0.6782|2-Sided|95.0|0.61|2.15|||Log Rank||HR was based upon the ratio of > = median cutpoint group hazard to < median cutpoint group.|Cycle 1, Day 1|
1763241|NCT00113516|3236995|Superiority or Other|||||||0.383|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28|
1763242|NCT00113516|3236995|Superiority or Other|||||||0.582|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763243|NCT00113516|3236995|Superiority or Other|||||||0.121|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763244|NCT00113516|3236995|Superiority or Other|||||||0.849|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763245|NCT00113516|3236995|Superiority or Other|||||||0.813|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763246|NCT00113516|3236996|Superiority or Other|||||||0.537|||||||Wilcoxon Rank Sum Test||||
1763247|NCT00113516|3236997|Superiority or Other|||||||0.772|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28|
1763248|NCT00113516|3236997|Superiority or Other|||||||0.287|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763249|NCT00113516|3236997|Superiority or Other|||||||0.236|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763250|NCT00113516|3236997|Superiority or Other|||||||0.438|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763251|NCT00113516|3236997|Superiority or Other|||||||0.738|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763252|NCT00113516|3236998|Superiority or Other|||||||0.305|||||||Wilcoxon Rank Sum Test||||
1763253|NCT00113516|3236999|Superiority or Other|||||||0.247|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 28|
1763254|NCT00113516|3236999|Superiority or Other|||||||0.029|||||||Wilcoxon Rank Sum Test|||Cycle 3, Day 1|
1763255|NCT00113516|3236999|Superiority or Other|||||||0.393|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 28|
1763256|NCT00113516|3236999|Superiority or Other|||||||0.071|||||||Wilcoxon Rank Sum Test|||Cycle 2, Day 1|
1763257|NCT00113516|3236999|Superiority or Other|||||||0.836|||||||Wilcoxon Rank Sum Test|||Cycle 1, Day 28|
1763258|NCT00113516|3237000|Superiority or Other|||||||0.474|||||||Wilcoxon Rank Sum Test||||
1763259|NCT00113516|3237014|Superiority or Other||Objective Response Rate (ORR) (percent)|27.4|||||2-Sided|95.0|18.2|38.2|||||||
1763260|NCT00113516|3237018|Superiority or Other||probability|0.405|||||2-Sided|90.0|0.315|0.494|||||The probability of survival along with the corresponding confidence interval (CI) (for the log [-log (1-year survival rate)]) was calculated using a normal approximation and then back transformed to give a CI for the 1-year survival rate itself.|The study was designed to test the null hypothesis that the true one-year probability of survival is 0.40 versus the alternative hypothesis that the true one-year probability of survival is at least 0.55. The sample size was determined using a One-Sample Survival design, assuming alpha=0.05 (1-sided), power= 0.90, 6 month accrual, a minimum follow-up period of 12 months, and an expectation that approximately 5% of subjects may be lost to follow-up.|
1763335|NCT00112437|3237177|Superiority or Other||Difference in Least Square Means|1.46|||||2-Sided|95.0|-1.54|4.46|||||||
1763261|NCT00113425|3237024|Superiority or Other|||||||0.01|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in acne severity for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763262|NCT00113425|3237025|Superiority or Other|||||||0.04|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in erythematous macules for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763263|NCT00113425|3237026|Superiority or Other|||||||0.27|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in open comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763264|NCT00113425|3237027|Superiority or Other|||||||0.21|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in closed comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763265|NCT00113425|3237028|Superiority or Other|||||||0.49|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in cysts for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763266|NCT00113425|3237029|Superiority or Other|||||||0.85|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in pustule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763267|NCT00113425|3237030|Superiority or Other|||||||0.62|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in papule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763268|NCT00113425|3237031|Superiority or Other|||||||0.003|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in acne severity for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763269|NCT00113425|3237032|Superiority or Other|||||||0.02|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in erythematous macules for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763270|NCT00113425|3237033|Superiority or Other|||||||0.73|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in open comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763271|NCT00113425|3237034|Superiority or Other|||||||0.1|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in closed comedones for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763272|NCT00113425|3237035|Superiority or Other|||||||0.79|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in cysts for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763273|NCT00113425|3237036|Superiority or Other|||||||0.43|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in pustule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763274|NCT00113425|3237037|Superiority or Other|||||||0.01|||||||paired t-test, 2-sided|||Null Hypothesis = There is no difference between change from baseline in papule acne lesions for the treated side of the face compared to the change from baseline for the untreated side of the face in all patients|
1763275|NCT00113295|3237054|Superiority or Other||Mean Difference (Net)|2.3|||<|0.05||||||No adjustment for multiple testing|t-test, 2 sided||This analysis applies to the additional reduction from phase 2 randomization to phase 2 endpoint in HAM-A scores.|In phase 2, comprising randomized double-blind quetiapine augmentation, change scores were examined with two-tailed, two-sample t tests, utilizing scores at phase 2 randomization as baseline. All analyses were intention to treat (ITT) with the last visit carried forward (LVCF) for subjects that did not complete the study.|
1763276|NCT00113269|3237056|Superiority or Other|||||||0.122|||||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'|
1763277|NCT00113269|3237056|Superiority or Other|||||||0.5231|||||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'|
1763278|NCT00113269|3237057|Superiority or Other|||||||0.1186|||||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'|
1763279|NCT00113269|3237057|Superiority or Other|||||||0.4735|||||||ANCOVA|Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.||P-Value applies to 'Change from Month 1'|
1763280|NCT00113269|3237058|Superiority or Other||differences in event rates|-1.4||||0.5655|2-Sided|95.0|-6.3|3.4|||normal approximation||||
1763281|NCT00113269|3237058|Superiority or Other||differences in event rates|5.9||||0.1797|2-Sided|95.0|-2.7|14.4|||normal approximation||||
1763282|NCT00113269|3237059|Superiority or Other||differences in event rates|-0.6||||0.682|2-Sided|95.0|-3.4|2.2|||normal approximation|Analysis based on normal approximation using Greenwood’s formula for standard error.|||
1763283|NCT00113269|3237059|Superiority or Other||differences in event rates|1.6||||0.5265|2-Sided|95.0|-3.4|6.7|||normal approximation|Analysis based on normal approximation using Greenwood’s formula for standard error.|||
1763284|NCT00113269|3237060|Superiority or Other||differences in event rates|-0.4||||0.9045|2-Sided|95.0|-6.5|5.7|||normal approximation||||
1763285|NCT00113269|3237060|Superiority or Other||differences in event rates|6.0||||0.3155|2-Sided|95.0|-5.7|17.6|||normal approximation||||
1763286|NCT00113269|3237061|Superiority or Other||differences in event rates|2.4||||0.2459|2-Sided|95.0|-1.7|6.5|||normal approximation|Analysis based on normal approximation using Greenwood’s formula for standard error.|||
1763336|NCT00112437|3237178|Superiority or Other||Difference in Least Square Means|8.13|||||2-Sided|95.0|3.8|12.46|||||||
1763287|NCT00113269|3237061|Superiority or Other||differences in event rates|3.5||||0.4134|2-Sided|95.0|-4.8|11.7|||normal approximation|Analysis based on normal approximation using Greenwood’s formula for standard error.|||
1763288|NCT00113269|3237063|Superiority or Other||differences in event rates|-14.1||||0.001|2-Sided|95.0|-22.5|-5.7|||normal approximation||||
1763289|NCT00113269|3237063|Superiority or Other||differences in event rates|1.1||||0.8742|2-Sided|95.0|-12.7|15.0|||normal approximation||||
1763290|NCT00113269|3237064|Superiority or Other||differences in event rates|-8.7||||0.0456|2-Sided|95.0|-17.2|-0.2|||normal approximation||||
1763291|NCT00113269|3237064|Superiority or Other||differences in event rates|-6.1||||0.4087|2-Sided|95.0|-20.7|8.4|||normal approximation||||
1763292|NCT00113269|3237065|Superiority or Other||differences in event rates|-11.9||||0.0024|2-Sided|95.0|-19.5|-4.2|||normal approximation||||
1763293|NCT00113269|3237065|Superiority or Other||differences in event rates|2.7||||0.6533|2-Sided|95.0|-9.0|14.3|||normal approximation||||
1763294|NCT00113269|3237066|Superiority or Other||differences in event rates|-15.7|||<|0.0001|2-Sided|95.305|-21.9|-9.4|||normal approximation|Analysis based on normal approximation using Greenwood’s formula for standard error.|95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood’s formula for standard error.||
1763295|NCT00113269|3237066|Superiority or Other||differences in event rates|-3.3|||<|0.4889|2-Sided|95.305|-12.7|6.1|||Normal approximation|Analysis based on normal approximation using Greenwood’s formula for standard error.|95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood’s formula for standard error.||
1763296|NCT00113087|3237070|Superiority or Other|||||||0.06|||||||Fisher Exact||||
1763297|NCT00113087|3237071|Superiority or Other|||||||0.08|||||||Fisher Exact||||
1763298|NCT00113087|3237072|Superiority or Other|||||||0.81|||||||t-test, 2 sided||||
1763299|NCT00113087|3237073|Superiority or Other|||||||0.34|||||||t-test, 2 sided||||
1763300|NCT00113087|3237074|Superiority or Other|||||||0.02|||||||t-test, 2 sided||||
1763301|NCT00113087|3237075|Superiority or Other|||||||0.43|||||||t-test, 2 sided||||
1763302|NCT00113087|3237076|Superiority or Other|||||||0.62|||||||t-test, 2 sided||||
1763303|NCT00113087|3237077|Superiority or Other|||||||0.35|||||||t-test, 2 sided||||
1763304|NCT00113087|3237078|Superiority or Other|||||||0.49|||||||t-test, 2 sided||||
1763305|NCT00113087|3237079|Superiority or Other|||||||0.11|||||||t-test, 2 sided||||
1763306|NCT00113087|3237080|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1763307|NCT00113087|3237081|Superiority or Other|||||||0.07|||||||t-test, 2 sided||||
1763308|NCT00113087|3237082|Superiority or Other|||||||0.08|||||||t-test, 2 sided||||
1763309|NCT00113087|3237083|Superiority or Other|||||||0.37|||||||t-test, 2 sided||||
1763310|NCT00113087|3237084|Superiority or Other|||||||0.36|||||||t-test, 2 sided||||
1763311|NCT00113087|3237085|Superiority or Other|||||||0.31|||||||Wilcoxon (Mann-Whitney)||||
1763312|NCT00113087|3237086|Superiority or Other|||||||0.004|||||||t-test, 2 sided||||
1763313|NCT00113087|3237087|Superiority or Other|||||||0.008|||||||t-test, 2 sided||||
1763314|NCT00113087|3237088|Superiority or Other|||||||0.01|||||||t-test, 2 sided||||
1763315|NCT00113087|3237089|Superiority or Other|||||||0.6|||||||Wilcoxon (Mann-Whitney)||||
1763316|NCT00113087|3237090|Superiority or Other|||||||0.6|||||||t-test, 2 sided||||
1763317|NCT00113087|3237091|Superiority or Other|||||||0.86|||||||t-test, 2 sided||||
1763318|NCT00113087|3237092|Superiority or Other|||||||0.22|||||||Wilcoxon (Mann-Whitney)||||
1763319|NCT00113087|3237093|Superiority or Other|||||||0.74|||||||Wilcoxon (Mann-Whitney)||||
1763320|NCT00113087|3237094|Superiority or Other|||||||0.71|||||||Fisher Exact||||
1763321|NCT00113087|3237095|Superiority or Other|||||||1|||||||Fisher Exact||||
1763322|NCT00113087|3237096|Superiority or Other||Median Difference (Final Values)|-0.64||||0.008||95.0|||||Mixed Models Analysis||||
1763323|NCT00113087|3237097|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.42||95.0|||||Mixed Models Analysis||||
1763324|NCT00113087|3237098|Superiority or Other||Mean Difference (Final Values)|-0.2|Standard Error of the Mean|0.18||0.28|2-Sided|95.0|||||Mixed Models Analysis||||
1763325|NCT00113022|3237099|Superiority or Other||Mean Difference (Final Values)|2.22|Standard Error of the Mean|18.867||0.919|2-Sided|95.0|-46.565|51.006||The test reported here examines the main effect for placebo versus drug.|Mixed Models Analysis||A positive value indicates greater depression in the active treatment group compared to placebo.|Per protocol, a linear mixed model with a first order autoregressive covariance structure was used. Baseline was included as a covariate. Drug and visit were main effects with an interaction between them included.|
1763326|NCT00112918|3237114|Superiority or Other|||||||0.2024|||||||Closed test procedure|||Adjustments for multiplicity was done using a closed test procedure which tests for differences between all three treatment groups at the 5% alpha level first. Only in case of a significant result, the pair-wise comparison between the control arm and each of the bevacizumab arm will be tested, again at the 5% alpha level.|
1763327|NCT00112437|3237169|Superiority or Other||Difference in Least Squares Means|209.44|||||2-Sided|95.0|127.14|291.73|||||||
1763328|NCT00112437|3237170|Superiority or Other||Difference in Least Square Means|49.1|||||2-Sided|95.0|13.37|84.83|||||||
1763329|NCT00112437|3237171|Superiority or Other||Difference in Least Square Means|-5.43|||||2-Sided|95.0|-42.04|31.18|||||||
1763330|NCT00112437|3237172|Superiority or Other||Difference in Least Square Means|16.59|||||2-Sided|95.0|-5.67|38.85|||||||
1763331|NCT00112437|3237173|Superiority or Other||Difference in Least Square Means|-39.25|||||2-Sided|95.0|-87.17|8.68|||||||
1763332|NCT00112437|3237174|Superiority or Other||Difference in Least Square Means|-34.25|||||2-Sided|95.0|-78.7|10.2|||||||
1763333|NCT00112437|3237175|Superiority or Other||Difference in Least Square Means|-78.06|||||2-Sided|95.0|-119.2|-36.92|||||||
1763334|NCT00112437|3237176|Superiority or Other||Difference in Least Square Means|2.47|||||2-Sided|95.0|-0.93|5.88|||||||
1763337|NCT00112437|3237179|Superiority or Other||Difference in Least Square Means|2.71|||||2-Sided|95.0|-0.16|5.57|||||||
1763338|NCT00112437|3237180|Superiority or Other||Difference in Least Square Means|6.31|||||2-Sided|95.0|3.44|9.17|||||||
1763339|NCT00112437|3237181|Superiority or Other||Difference in Least Square Means|6.45|||||2-Sided|95.0|3.38|9.53||||||In postmenopausal women with osteoporosis assess the time course of resolution of effect on lumbar spine BMD during the 12 month extension following 24 months of treatment with odanacatib once weekly. The primary objective was to assess the resolution of effect, on lumbar spine BMD, for the participants who received odanacatib 50 mg for 3 years compared to those who received odanacatib 50 mg in the 2nd year and switched to placebo for the 3rd year extension.|
1763340|NCT00112437|3237182|Superiority or Other||Difference in Least Square Means|49.23|||||2-Sided|95.0|23.86|74.59|||||Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.|
1763341|NCT00112437|3237182|Superiority or Other||Difference in Least square means|7.77|||||2-Sided|95.0|-13.46|29.01|||||Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.|
1763342|NCT00112437|3237182|Superiority or Other||Difference in Least square means|13.31||||0.618||95.0|-7.1|33.71||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least square means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.|
1763343|NCT00112437|3237182|Superiority or Other||Difference in Least Squares Means|-21.49||||0.011|2-Sided|95.0|-39.55|-3.43||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 24 months.|
1763344|NCT00112437|3237183|Superiority or Other||Difference in Least Square Means|36.79||||||95.0|21.19|52.38|||||Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.|
1763345|NCT00112437|3237183|Superiority or Other||Difference in Least Square Means|-0.39||||||95.0|-13.69|12.92|||||Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.|
1763346|NCT00112437|3237183|Superiority or Other||Difference in Least Square Means|7.24||||0.852||95.0|-5.73|20.21||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.|
1763347|NCT00112437|3237183|Superiority or Other||Difference in Least Square Means|-16.64||||0.002||95.0|-28.84|-4.44||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 24 months.|
1763348|NCT00112437|3237184|Superiority or Other||Difference in Least Square Means|21.74||||||95.0|-1.32|44.81|||||Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.|
1763349|NCT00112437|3237184|Superiority or Other||Difference in Least Square Means|-1.79||||||95.0|-22.66|19.08|||||Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.|
1763388|NCT00112437|3237194|Superiority or Other||Difference in Least Squares Means|28.15|||||2-Sided|95.0|5.84|50.46|||||Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.|
1763350|NCT00112437|3237184|Superiority or Other||Difference in Least Square Means|-8.51||||0.246||95.0|-27.31|10.29||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.|
1763351|NCT00112437|3237184|Superiority or Other||Difference in Least Square Means|-16.71||||0.015||95.0|-36.03|2.61||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of MK0822 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 24 months. The secondary hypothesis states that MK0822 will decrease biochemical indices of bone resorption (u-DPyr) over 24 months.|
1763352|NCT00112437|3237185|Superiority or Other||Difference in Least Squares Means|22.18|||||2-Sided|95.0|-12.38|56.73|||||Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.|
1763353|NCT00112437|3237185|Superiority or Other||Difference in Least Squares Means|-23.98||||0.124|2-Sided|95.0|-53.04|5.09||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.|
1763354|NCT00112437|3237185|Superiority or Other||Difference in Least Squares Means|-39.29|||<=|0|2-Sided|95.0|-65.4|-13.18||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.|
1763355|NCT00112437|3237185|Superiority or Other||Difference in Least Square Means|-63.34|||<=|0||95.0|-88.32|-38.36||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline).|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 24 months.|
1763356|NCT00112437|3237186|Superiority or Other||Difference in Least Squares Means|17.51||||0.101|2-Sided|95.0|-6.78|41.8||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handle by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.|
1763357|NCT00112437|3237186|Superiority or Other||Difference in Least Square Means|-35.94|||<=|0||95.0|-54.15|-17.74||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.|
1763459|NCT00112047|3237354|Superiority or Other|||||||0.055||||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) total body fat value is not equal to zero.|
1763358|NCT00112437|3237186|Superiority or Other||Difference in Least Square Means|-33.67|||<=|0||95.0|-51.44|-15.91||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.|
1763359|NCT00112437|3237186|Superiority or Other||Difference in Least Square Means|-47.21|||<=|0||95.0|-64.51|-29.9||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Square Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 24 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 24 months.|
1763360|NCT00112437|3237187|Superiority or Other||Difference in Least square means|-2.95||||||95.0|-4.5|-1.4||||||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.|
1763361|NCT00112437|3237187|Superiority or Other||Difference in Least square means|1.53||||0.094||95.0|-0.01|3.07||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.|
1763362|NCT00112437|3237187|Superiority or Other||Difference in Least square means|2.09|||<=|0||95.0|0.59|3.6||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.|
1763363|NCT00112437|3237187|Superiority or Other||Difference in Least square means|2.9|||<=|0|2-Sided|95.0|1.34|4.46||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Distal Forearm BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Distal Forearm BMD compared to placebo over 24 months.|
1763364|NCT00112437|3237188|Superiority or Other||Difference in Least square means|-1.15|||||2-Sided|95.0|-2.46|0.15||||||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.|
1763365|NCT00112437|3237188|Superiority or Other||Difference in Least square means|0.2||||0.804||95.0|-1.1|1.49||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.|
1763366|NCT00112437|3237188|Superiority or Other||Difference in Least square means|1.11||||0.028||95.0|-0.12|2.34||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.|
1763367|NCT00112437|3237188|Superiority or Other||Difference in Least square means|1.73|||<=|0||95.0|0.46|3.01||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on Total Body BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase Total Body BMD compared to placebo over 24 months.|
1763368|NCT00112437|3237189|Superiority or Other||Difference in Least Squares Means|-0.04||||0.981|2-Sided|95.0|-1.97|1.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.|
1763369|NCT00112437|3237189|Superiority or Other||Difference in Least Squares Means|4.43|||<=|0|2-Sided|95.0|2.52|6.33||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.|
1763370|NCT00112437|3237189|Superiority or Other||Difference in Least Squares Means|4.56|||<=|0|2-Sided|95.0|2.7|6.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.|
1763371|NCT00112437|3237189|Superiority or Other||Difference in Least Squares Means|5.09|||<=|0|2-Sided|95.0|3.18|7.01||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 24 months.|
1763372|NCT00112437|3237190|Superiority or Other||Difference in Least Squares Means|-0.41||||0.585|2-Sided|95.0|-1.85|1.04||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.|
1763373|NCT00112437|3237190|Superiority or Other||Difference in Least Squares Means|2.82|||<=|0|2-Sided|95.0|1.39|4.25||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.|
1763374|NCT00112437|3237190|Superiority or Other||Difference in Least Square Means|3.57|||<=|0|2-Sided|95.0|2.18|4.97||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.|
1763375|NCT00112437|3237190|Superiority or Other||Difference in Least Squares Means|4.69|||<=|0|2-Sided|95.0|3.25|6.12||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 24 months.|
1763376|NCT00112437|3237191|Superiority or Other||Difference in Least Squares Means|-0.51||||0.536|2-Sided|95.0|-1.84|0.83||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.|
1763574|NCT00110812|3237506|Superiority or Other||Mean Difference (Final Values)|-55.9|Standard Error of the Mean|28.4||0.05||95.0|||||ANOVA|Last measured CD4 is imputed if month 24 CD4 count is missing. Analysis is adjusted for baseline CD4.|IL-2 group minus control group CD4.||
1763377|NCT00112437|3237191|Superiority or Other||Difference in Least Squares Means|2.75|||<=|0|2-Sided|95.0|1.43|4.07||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.|
1763378|NCT00112437|3237191|Superiority or Other||Difference in Least Squares Means|3.48|||<=|0|2-Sided|95.0|2.2|4.77||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.|
1763379|NCT00112437|3237191|Superiority or Other||Difference in Least Squares Means|4.1|||<=|0|2-Sided|95.0|2.77|5.42||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 24 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 24 months.|
1763380|NCT00112437|3237192|Superiority or Other||Difference in Least Squares Means|46.9|||||2-Sided|95.0|22.35|71.44|||||Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.|
1763381|NCT00112437|3237192|Superiority or Other||Difference in Least Squares Means|-1.58|||||2-Sided|95.0|-20.99|17.82|||||Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.|
1763382|NCT00112437|3237192|Superiority or Other||Difference in Least Squares Means|-1.68||||0.161|2-Sided|95.0|-20.58|17.23||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.|
1763383|NCT00112437|3237192|Superiority or Other||Difference in Least Squares Means|-35.74|||<=|0|2-Sided|95.0|-52.14|-19.33||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation of difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-P1NP) compared to placebo over 12 months.|
1763384|NCT00112437|3237193|Superiority or Other||Difference in Least Squares Means|44.85|||||2-Sided|95.0|30.55|59.16|||||Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.|
1763385|NCT00112437|3237193|Superiority or Other||Difference in Least Squares Means|11.73|||||2-Sided|95.0|-0.47|23.92|||||Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.|
1763386|NCT00112437|3237193|Superiority or Other||Difference in Least Squares Means|5.43||||0.645|2-Sided|95.0|-6.02|16.89||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.|
1763387|NCT00112437|3237193|Superiority or Other||Difference in Least Squares Means|-15.57|||<=|0|2-Sided|95.0|-26.11|-5.04||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance.|Difference in Least Squares Means (back-transformation from difference in log-fraction from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone formation (s-BSAP) compared to placebo over 12 months.|
1764485|NCT00095498|3239349|Superiority or Other||||||<|0.001|||||||van Elteren Stratified Rank Test||||
1763389|NCT00112437|3237194|Superiority or Other||Difference in Least Squares Means|-1.33|||||2-Sided|95.0|-20.55|17.89|||||Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.|
1763390|NCT00112437|3237194|Superiority or Other||Difference in Least Squares Means|-1.26||||0.344|2-Sided|95.0|-19.9|17.39||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.|
1763391|NCT00112437|3237194|Superiority or Other||Difference in Least Squares Means|-18.28||||0.004|2-Sided|95.0|-35.82|-0.74||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-DPyr) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-DPyr) over 12 months.|
1763392|NCT00112437|3237195|Superiority or Other||Difference in Least Squares Means|19.7|||||2-Sided|95.0|-8.48|47.88|||||Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.|
1763393|NCT00112437|3237195|Superiority or Other||Difference in Least Squares Means|-21.66||||0.08||95.0|-44.54|1.23||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.|
1763394|NCT00112437|3237195|Superiority or Other||Difference in Least Square Means|-35.57|||<=|0||95.0|-56.63|-14.51||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Square Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.|
1763395|NCT00112437|3237195|Superiority or Other||Difference in Least Squares Means|-56.33|||<=|0||95.0|-75.86|-36.81||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation from difference in log-fraction)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (s-CTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (s-CTx) over 12 months.|
1763396|NCT00112437|3237196|Superiority or Other||Difference in Least Square Means|11.17||||0.249|2-Sided|95.0|-0.94|43.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.|
1763407|NCT00112437|3237198|Superiority or Other||Difference in Least Squares Means|0.29||||0.112|2-Sided|95.0|-0.77|1.35||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.|
1763397|NCT00112437|3237196|Superiority or Other||Difference in Least Squares Means|-31.84|||<=|0|2-Sided|95.0|-48.11|-15.58||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.|
1763398|NCT00112437|3237196|Superiority or Other||Difference in Least Squares Means|-45.92|||<=|0|2-Sided|95.0|-60.93|-30.91||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.|
1763399|NCT00112437|3237196|Superiority or Other||Difference in Least Squares Means|-57.86|||<=|0|2-Sided|95.0|-72.33|-43.38||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model of log-fraction with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor, 5% significance|Difference in Least Squares Means (back-transformation of difference in log-fractions from baseline)|The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on biochemical indices of bone resorption (u-NTx) compared to placebo over 12 months. The secondary hypothesis states that odanacatib will decrease biochemical indices of bone resorption (u-NTx) over 12 months.|
1763400|NCT00112437|3237197|Superiority or Other||Difference in Least Squares Means|-1.27|||||2-Sided|95.0|-2.28|-0.27||||||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.|
1763401|NCT00112437|3237197|Superiority or Other||Difference in Least Squares Means|0.27||||0.63|2-Sided|95.0|-0.74|1.29||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.|
1763402|NCT00112437|3237197|Superiority or Other||Difference in Least Squares Means|1.1||||0.005|2-Sided|95.0|0.09|2.11||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.|
1763403|NCT00112437|3237197|Superiority or Other||Difference in Least Squares Means|1.23|||<=|0|2-Sided|95.0|0.22|2.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on distal forearm BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase distal forearm BMD compared to placebo over 12 months.|
1763404|NCT00112437|3237198|Superiority or Other||Difference in Least Squares Means|-1.47|||||2-Sided|95.0|-2.53|-0.42||||||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.|
1763405|NCT00112437|3237198|Superiority or Other||Difference in Least Squares Means|-0.63|||||2-Sided|95.0|-1.69|0.42||||||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.|
1763406|NCT00112437|3237198|Superiority or Other||Difference in Least Squares Means|-0.09|||||2-Sided|95.0|-1.13|0.95||||||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total body BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total body BMD compared to placebo over 12 months.|
1763438|NCT00112294|3237271|Superiority or Other||Odds Ratio (OR)|1.675||||0.0066|2-Sided|95.0|1.152|2.436|||Cochran-Mantel-Haenszel||The odds ratio is presented for C/T/C to T/C.|The 2 groups were compared by means of a Cochran-Mantel-Haenszel (CMH) (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.|
1763575|NCT00110812|3237507|Superiority or Other||Hazard Ratio (HR)|1.45||||0.59|2-Sided|95.0|0.38|5.45|||Regression, Cox|Stratification by region.|IL-2 group compared to control group||
1763408|NCT00112437|3237199|Superiority or Other||Difference in Least Squares Means|-0.29||||0.731|2-Sided|95.0|-1.58|1.0||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.|
1763409|NCT00112437|3237199|Superiority or Other||Difference in Least Squares Means|2.38|||<=|0|2-Sided|95.0|1.08|3.69||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.|
1763410|NCT00112437|3237199|Superiority or Other||Difference in Least Squares Means|2.65|||<=|0|2-Sided|95.0|1.35|3.94||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.|
1763411|NCT00112437|3237199|Superiority or Other||Difference in Least Squares Means|2.94|||<=|0|2-Sided|95.0|1.64|4.24||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on trochanter BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase trochanter BMD compared to placebo over 12 months.|
1763412|NCT00112437|3237200|Superiority or Other||Difference in Least Squares Means|-0.19|||||2-Sided|95.0|-1.14|0.75||||||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.|
1763413|NCT00112437|3237200|Superiority or Other||Difference in Least Squares Means|0.87||||0.095|2-Sided|95.0|-0.09|1.82||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.|
1763414|NCT00112437|3237200|Superiority or Other||Difference in Least Squares Means|1.89|||<=|0|2-Sided|95.0|0.93|2.84||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.|
1763415|NCT00112437|3237200|Superiority or Other||Difference in Least Squares Means|2.66|||<=|0|2-Sided|95.0|1.71|3.61||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on femoral neck BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase femoral neck BMD compared to placebo over 12 months.|
1763416|NCT00112437|3237201|Superiority or Other||Difference in Least Squares Means|-0.75||||0.135|2-Sided|95.0|-1.61|0.11||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.|
1763457|NCT00112047|3237352|Superiority or Other|||||||0.12||||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).|
1764486|NCT00095498|3239349|Superiority or Other||||||<|0.001|||||||van Elteren Stratified Rank Test||||
1763417|NCT00112437|3237201|Superiority or Other||Difference in Least Squares Means|1.67|||<=|0|2-Sided|95.0|0.8|2.53||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.|
1763418|NCT00112437|3237201|Superiority or Other||Difference in Least Squares Means|2.06|||<=|0|2-Sided|95.0|1.2|2.93||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.|
1763419|NCT00112437|3237201|Superiority or Other||Difference in Least Squares Means|2.49|||<=|0|2-Sided|95.0|1.62|3.35||Significance for secondary endpoints was only declared if there was also significance for the primary endpoint. Multiplicity was addressed through a stepdown trend-test approach. Multiplicity for multiple endpoints was handled by a Hochberg procedure|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The secondary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on total hip BMD compared to placebo over 12 months. The secondary hypothesis states that odanacatib will increase total hip BMD compared to placebo over 12 months.|
1763420|NCT00112437|3237202|Superiority or Other||Difference in Least Square Means|-0.84||||0.218||95.0|-2.19|0.51||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.|
1763421|NCT00112437|3237202|Superiority or Other||Difference in Least Squares Means|3.39|||<=|0|2-Sided|95.0|2.06|4.73||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.|
1763422|NCT00112437|3237202|Superiority or Other||Difference in Least Squares Means|4.45|||<=|0|2-Sided|95.0|3.15|5.76||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.|
1763423|NCT00112437|3237202|Superiority or Other||Difference in Least Squares Means|5.67|||<=|0|2-Sided|95.0|4.32|7.02||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 24 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 24 months.|
1763424|NCT00112437|3237203|Superiority or Other||Difference in Least Squares Means|-0.49||||0.343|2-Sided|95.0|-1.44|0.46||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.|
1763425|NCT00112437|3237203|Superiority or Other||Difference in Least Squares Means|1.63||||0.003|2-Sided|95.0|0.68|2.59||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.|
1763458|NCT00112047|3237353|Superiority or Other||||||<|0.001||||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).|
1764487|NCT00095498|3239350|Superiority or Other||||||<|0.001|||||||van Elteren Stratified Rank Test||||
1763426|NCT00112437|3237203|Superiority or Other||Difference in Least Squares Means|2.78|||<=|0|2-Sided|95.0|1.82|3.73||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.|
1763427|NCT00112437|3237203|Superiority or Other||Difference in Least Squares Means|3.5|||<=|0|2-Sided|95.0|2.54|4.45||Significance for the primary endpoint was achieved through stepdown trend-test, the highest dose group was removed and the test was repeated until lack of significance was observed.|ANCOVA|Stepwise linear trend test on ANCOVA model with treatment (scales 0, 1, 2, 3, 4) as covariate and center as factor in the model, with 5% significance.||The primary objective was to assess the effect of odanacatib 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. The primary hypothesis states that odanacatib will increase lumbar spine BMD compared to placebo over 12 months.|
1763428|NCT00112359|3237247|Superiority or Other|||||||0.064||||||No adjustments were made for multiple comparisons.|Fisher Exact|Comparison by treatment group for proportion of participants hospitalized at least once between Day 0 and Day 42 (or 14 days after last study dose).||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants hospitalized at least once during the study.|
1763429|NCT00112359|3237248|Superiority or Other||Mean Difference (Final Values)|9.71||||0.0005|2-Sided|95.0|4.31|15.11||"Primary endpoint analysis based on 2-sided test with an 0.05 a priori threshold for statistical significance.~A gate-keeping procedure to control family-wise Type 1 error was established a priori for primary and key secondary endpoints."|ANCOVA|ANCOVA model includes treatment, baseline CFQ-R RSS, and disease severity (FEV1 >50% or <=50% pred.). Treatment differences: AZLI-placebo.||"Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 28.~A sample size of 70 participants per treatment group provided approximately 77% power to detect an 8-point difference in CFQ-R RSS score between treatment groups, assuming a standard deviation (SD) of 20 and a Type I error rate of 0.05."|
1763430|NCT00112359|3237249|Superiority or Other|||||||0.2364||||||Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.|Fisher Exact|Comparison by treatment for proportion of subjects using additional (nonprotocol-specified) antipseudomonal antibiotics at least once during study.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in number of participants using additional (nonprotocol-specified) antipseudomonal antibiotics during study.|
1763431|NCT00112359|3237250|Superiority or Other||Mean Difference (Final Values)|-1.453|||<|0.0001|2-Sided|95.0|-2.115|-0.791||Analysis based on 2-sided test with an 0.025 a priori threshold for statistical significance as part of methods used to control family-wise type 1 error.|ANCOVA|ANCOVA model included terms for treatment and disease severity (FEV1 >50% or <=50% pred.). Treatment differences calculated as AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change in log10 PA CFUs in sputum at Day 28.|
1763432|NCT00112359|3237251|Superiority or Other||Median Difference (Final Values)|10.294|||<|0.0001|2-Sided|95.0|6.288|14.299||Analysis based on two-sided test with an 0.025 a priori threshold for statistical significance as part of the methods used to control the family-wise type 1 error.|ANCOVA|ANCOVA model included treatment, disease severity (FEV1 >50% or <=50% pred.), and Day 0 FEV1. Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in percent change in FEV1 at Day 28.|
1763433|NCT00112359|3237254|Superiority or Other||Mean Difference (Final Values)|6.33||||0.0154|2-Sided|95.0|1.22|11.43||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 >50% or <=50% pred.). Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 42.|
1763434|NCT00112359|3237255|Superiority or Other||Mean Difference (Final Values)|7.98||||0.0006|2-Sided|95.0|3.5|12.47||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included treatment, baseline CFQ-R RSS, and disease severity (FEV1 >50% or <=50% pred.). Treatment differences: AZLI-placebo.||Null hypothesis was there was no difference between 75 mg AZLI TID and placebo treatment groups in change from baseline in CFQ-R RSS score at Day 14.|
1763435|NCT00112294|3237266|Superiority or Other|||||||0.26|||||||Cochran-Mantel-Haenszel|||Improvement of symptoms was compared between groups by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.|
1763436|NCT00112294|3237267|Superiority or Other||Hazard Ratio (HR)|0.89||||0.1685|2-Sided|95.0|0.754|1.051||An interim analysis on survival was performed. Final p-value was adjusted using an alpha spending function. At the interim analysis (data not reported here) the type 1 error was 0.0001, and the rest is for the final look.|Log Rank||The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox’s proportional hazard model with treatment as the single covariate.|Confidence intervals were calculated using Brookmeyer and Crowley method. Analysis was a comparison of survival between groups by means of a 2-sided, alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that survival was equal in both treatment arms. Power calculations indicated that >= 558 events would lead to at >=75% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.8.|
1763437|NCT00112294|3237270|Superiority or Other||Odds Ratio (OR)|1.265||||0.1501|2-Sided|95.0|0.918|1.741|||Cochran-Mantel-Haenszel||The odds ratio is presented for C/T/C to T/C.|The 2 groups were compared by means of a CMH (alpha = 0.05 level) test stratified by ECOG PS (0 or 1) and intended on-study taxane (paclitaxel, docetaxel), as recorded at the time of randomization.|
1763572|NCT00110890|3237503|Superiority or Other||Odds Ratio (OR)|8.74|||<|0.001||95.0|5.72|13.36|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg^2/dL^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg^2/dL^2||
1763439|NCT00112294|3237272|Superiority or Other||Hazard Ratio (HR)|0.902||||0.2358|2-Sided|95.0|0.761|1.069||Since only 1 primary comparison was conducted, no adjustment for multiple comparisons was needed.|Log Rank||The hazard ratio of C/T/C to T/C was estimated by means of a stratified Cox’s proportional hazard model, with treatment as the single covariate.|Confidence intervals calculated using Brookmeyer and Crowley method. Primary analysis was comparison of PFS between arms performed by 2-sided alpha=0.05 level, log-rank test, stratified by ECOG PS (0/1) and intended on-study taxane (docetaxel or paclitaxel). Null hypothesis was that PFS was equal in both groups. Power calculations indicated that >=510 events (IRRC progressions/deaths) would lead to >=90% power at the 5% level for rejecting the null hypothesis, given a true hazard ratio of 0.75.|
1763440|NCT00112151|3237273|Superiority or Other||||||<|0.05|||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.|
1763441|NCT00112151|3237273|Superiority or Other||||||<|0.05|||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat free mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.|
1763442|NCT00112151|3237274|Superiority or Other||||||<|0.05|||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to no PRT.|
1763443|NCT00112151|3237274|Superiority or Other||||||<|0.05|||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in fat mass measured by dual x-ray absorptiometry (DXA) with any T to placebo in subjects assigned to PRT.|
1763444|NCT00112151|3237275|Superiority or Other||||||<|0.05|||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to no PRT.|
1763445|NCT00112151|3237275|Superiority or Other||||||<|0.05|||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in leg extensor power with any T to placebo in subjects assigned to PRT.|
1763446|NCT00112151|3237276|Superiority or Other||||||<|0.05|||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to no PRT.|
1763447|NCT00112151|3237276|Superiority or Other||||||<|0.05|||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average lower body strength with any T to placebo in subjects assigned to PRT.|
1763448|NCT00112151|3237277|Superiority or Other||||||<|0.05|||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to no PRT.|
1763449|NCT00112151|3237277|Superiority or Other||||||<|0.05|||||||Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (Any T). The analysis compared change from baseline to 12 months in average upper body strength with any T to placebo in subjects assigned to PRT.|
1763450|NCT00112151|3237278|Superiority or Other||||||<|0.025||||||A one-sided P-value of <0.025 was used to define statistical significance.|Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (any T). To address whether the effects of any T on physical function are the same without PRT, the analysis was also conducted in the No PRT groups, comparing CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.|
1763451|NCT00112151|3237278|Superiority or Other||||||<|0.025||||||A one-sided P-value of <0.025 was used to define statistical significance|Regression, Linear|||As prespecified, the lower- and higher-range T groups were combined (any T). The primary analysis was conducted in the PRT groups and compared CS-PFP at 12 months with any T to placebo, adjusted for baseline CS-PFP score.|
1763452|NCT00112047|3237347|Superiority or Other|||||||0.23||||||P-value is from the Wilcoxon Signed Rank Test|Wilcoxon Signed Rank Test|||Null Hypothesis: There is no change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the MCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).|
1763453|NCT00112047|3237348|Superiority or Other|||||||0.95||||||P-value is from the Wilcoxon Signed Rank Test.|Wilcoxon Signed Rank Test|||Null Hypothesis: There is no change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a change in the PCS score from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).|
1763454|NCT00112047|3237349|Superiority or Other|||||||0.7||||||"The number and proportion of participants in each category (bothers, does not bother) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).|
1763455|NCT00112047|3237350|Superiority or Other|||||||0.013||||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).|
1763456|NCT00112047|3237351|Superiority or Other|||||||0.037||||||"The number and proportion of participants in each category (very satisfied, not very satisfied) were summarized. The P-value for the category shift from Week 144 baseline within a treatment group was calculated using the McNemar test."|McNemar|||Null Hypothesis: There is no category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96). Alternative Hypothesis: There is a category shift from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96).|
1763573|NCT00110812|3237504|Superiority or Other||Hazard Ratio (HR)|0.71||||0.03|2-Sided|95.0|0.52|0.97|||Regression, Cox||IL-2 groups vs. control||
1763460|NCT00112047|3237355|Superiority or Other|||||||0.049||||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) trunk fat value is not equal to zero.|
1763461|NCT00112047|3237356|Superiority or Other|||||||0.16||||||P-value is from the Wilcoxon Signed Rank test. No adjustments for multiple comparisons were made|Wilcoxon Signed Rank test|||Null Hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is equal to zero. Alternative hypothesis: Change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) limb fat value is not equal to zero.|
1763462|NCT00112047|3237366|Superiority or Other||||||<|0.001||||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different|
1763463|NCT00112047|3237367|Superiority or Other|||||||0.011||||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different|
1763464|NCT00112047|3237368|Superiority or Other|||||||0.001||||||P-value is from the Wilcoxon Rank Sum Test|Wilcoxon Rank Sum test|No other adjustments were made||Null Hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 baseline to Week 144 in Limb Fat for the EFV+FTC+TDF and CBV+EFV groups are different|
1763465|NCT00112047|3237369|Superiority or Other||Mean Difference (Net)|41.3||||0.089|2-Sided|95.0|4.05|78.55||The change from baseline to Week 144 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made||Null Hypothesis: Changes from baseline toWeek 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.|
1763466|NCT00112047|3237370|Superiority or Other||Mean Difference (Net)|-0.04||||0.39|2-Sided|95.0|-0.16|0.08||The change from baseline to Week 144 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from a stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made||Null Hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline to Week 144 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.|
1763467|NCT00112047|3237371|Superiority or Other|||||||0.3||||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 50 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 50 c/mL) at Week 144 is different between the 2 treatment groups|
1763468|NCT00112047|3237372|Superiority or Other|||||||0.066||||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 400 c/mL) at Week 144 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 400 c/mL) at Week 144 is different between the 2 treatment groups|
1763469|NCT00112047|3237373|Superiority or Other|||||||0.056||||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 50 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different|
1763470|NCT00112047|3237374|Superiority or Other|||||||0.003||||||The distribution of loss of virological response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 400 c/mL) through Week 144 for the EFV+FTC+TDF and CBV+EFV groups are different|
1763471|NCT00112047|3237375|Non-Inferiority or Equivalence|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.|Difference in proportions|10.4||||0.019|2-Sided|95.0|1.8|19.0||The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null hypothesis: The percentage of participants with HIV-1 RNA < 50 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA < 50 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.|
1763482|NCT00112047|3237386|Superiority or Other|||||||0.124||||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different|
1763472|NCT00112047|3237376|Non-Inferiority or Equivalence|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.|Difference in proportions|11.6||||0.009||95.0|3.1|20.1||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null Hypothesis: The percentage of participants with HIV-1 RNA < 400 c/mL at Week 144 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA < 400 c/mL at Week 144 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.|
1763473|NCT00112047|3237377|Non-Inferiority or Equivalence|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.|Difference in proportions|8.1||||0.082|2-Sided|95.0|-0.8|17.0||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA < 50 c/mL [defined by the TLOVR algorithm]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA < 50 c/mL [defined by the TLOVR algorithm]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."|
1763474|NCT00112047|3237378|Non-Inferiority or Equivalence|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.|Difference in proportions|12.9||||0.004|2-Sided|95.0|4.2|21.6||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenzel test.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the proportion of responders (who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 144 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the proportion of responders who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 144 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."|
1763475|NCT00112047|3237379|Superiority or Other||||||<|0.001||||||The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum test|No other adjustments were made.||Null Hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Total Body Fat for the EFV+FTC+TDF and CBV+EFV groups are different|
1763476|NCT00112047|3237380|Superiority or Other|||||||0.025||||||The change from Week 48 to Week 96 in trunk fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum test|No other adjustments were made.||Null Hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from Week 48 to Week 96 in Trunk Fat for the EFV+FTC+TDF and CBV+EFV groups are different|
1763477|NCT00112047|3237381|Superiority or Other||||||<|0.001||||||The change from Week 48 to Week 96 in limb fat was compared between the 2 treatment groups; the P-value is from the Wilcoxon Rank Sum Test.|Wilcoxon Rank Sum Test|No other adjustments were made.||Null Hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Change from Week 48 to Week 96 in limb fat for the EFV+FTC+TDF and CBV+EFV groups are not equal|
1763478|NCT00112047|3237382|Superiority or Other||stratum-weighted difference|32.93||||0.036||95.0|0.87|64.99||The change from baseline to Week 96 in CD4 cell count was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.|
1763479|NCT00112047|3237383|Superiority or Other||stratum-weighted difference|-0.05||||0.45||95.0|-0.17|0.08||The change from baseline to Week 96 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 96 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.|
1763480|NCT00112047|3237384|Superiority or Other|||||||0.41||||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA < 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (HIV-1 RNA < 50 c/mL) through Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different|
1763481|NCT00112047|3237385|Superiority or Other|||||||0.025||||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 400 c/mL) at Week 96 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 400 c/mL) at Week 96 is different between the 2 treatment groups.|
1763505|NCT00111800|3237432|Superiority||Mean Difference (Net)|3.31||||0.327|2-Sided|95.0|-3.32|9.94|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg for pro-insulin.|Placebo versus DEN 2.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763483|NCT00112047|3237387|Superiority or Other|||||||0.003||||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: Ther percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with loss of virologic response (confirmed HIV-1 RNA < 400 c/mL) at Week 96 for the EFV+FTC+TDF and CBV+EFV groups are different|
1763484|NCT00112047|3237388|Non-Inferiority or Equivalence|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.|Difference in proportions|6.4||||0.158|2-Sided|95.0|-2.3|15.0||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA < 50 c/mL [defined by the TLOVR algorithm]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA < 50 c/mL [defined by the TLOVR algorithm]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."|
1763485|NCT00112047|3237389|Non-Inferiority or Equivalence|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.|Difference in percentages|12.7||||0.004|2-Sided|95.0|4.3|21.1||The difference and 95% CI are stratum weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from Cochran-Mantel-Haenszel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 96 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 96 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."|
1763486|NCT00112047|3237390|Superiority or Other||stratum-weighted difference|31.74||||0.002||95.0|8.96|54.52||The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in CD4 cell count for the EFV+FTC+TDF and CBV+EFV groups are different.|
1763487|NCT00112047|3237391|Superiority or Other||Mean Difference (Net)|-0.05||||0.31|2-Sided|95.0|-0.16|0.06||The change from baseline to Week 48 in HIV-1 RNA was compared between the 2 treatment groups using baseline CD4 stratum-weighted CI around the mean difference. P-value is from stratum-weighted Van Elteren test.|Van Elteren|No other adjustments were made.||Null Hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative hypothesis: Changes from baseline through Week 48 in plasma HIV-1 RNA for the EFV+FTC+TDF and CBV+EFV groups are different.|
1763488|NCT00112047|3237392|Superiority or Other|||||||0.063||||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are equal. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 50 c/mL) through Week 48 for the EFV+FTC+TDF and CBV+EFV groups are different.|
1763489|NCT00112047|3237393|Superiority or Other|||||||0.026||||||The distribution of pure virological failure was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 400 c/mL) at Week 48 is equal for the 2 treatment groups. Alternative Hypothesis: The percentage of participants with pure virological failure (confirmed HIV-1 RNA < 400 c/mL) at Week 48 is different between the 2 treatment groups.|
1763490|NCT00112047|3237394|Superiority or Other|||||||0.046||||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.|
1763491|NCT00112047|3237395|Superiority or Other|||||||0.003||||||The distribution of time to loss-of-virologic response was estimated using the Kaplan-Meier product limit method and compared between treatment groups using a baseline CD4 stratum-weighted log-rank test.|Log Rank|No other adjustments were made.||Null Hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is equal between the two treatment groups. Alternative hypothesis: The percentage of participants with Loss of Virologic Response through Week 48 is different between the two treatment groups.|
1763492|NCT00112047|3237396|Non-Inferiority or Equivalence|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.|Difference in percentages|7.9||||0.058|2-Sided|95.0|0.1|15.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||Null hypothesis: The percentage of participants with HIV-1 RNA < 50 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA < 50 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.|
1763493|NCT00112047|3237397|Non-Inferiority or Equivalence|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.|Difference in percentages|11.2||||0.004|2-Sided|95.0|3.7|18.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made||Null hypothesis: The percentage of participants with HIV-1 RNA < 400 c/mL at Week 48 in the EFV+FTC+TDF group is more than 13% worse than the CBV+EFV group. Alternative hypothesis: The percentage of participants with HIV-1 RNA < 400 c/mL at Week 48 in the EFV+FTC+TDF group is no more than 13% worse than the CBV+EFV group.|
1763494|NCT00112047|3237398|Non-Inferiority or Equivalence|The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.|Difference in percentages|9.1||||0.021|2-Sided|95.0|1.6|16.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA < 50 c/mL [defined by the TLOVR algorithm]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA < 50 c/mL [defined by the TLOVR algorithm]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."|
1763495|NCT00112047|3237399|Non-Inferiority or Equivalence|Assuming 70% response rate for each group at Week 48, 500 participants (250 per group) were sufficient to achieve at least 85% power to establish non-inferiority between the 2 study groups with a delta of 13%. The definition of clinical non-inferiority used a 'delta' of 0.13 (response rate was expressed as a decimal-valued number between 0 and 1). The EFV+FTC+TDF group was declared non-inferior to the CBV+EFV group if the lower confidence bound was > −0.13.|Difference in percentages|11.4||||0.002|2-Sided|95.0|4.3|18.6||The difference and 95% CI are stratum-weighted on baseline CD4 using normal approximation. The p-value for the superiority test is from the Cochran-Mantel-Haenzel test stratified on baseline CD4 cell count.|Cochran-Mantel-Haenszel|No other adjustments were made.||"Null Hypothesis: the percentage of responders (who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 48 in the EFV+FTC+TDF group is more than 13% worse than in the CBV+EFV group.~Alternative Hypothesis: the percentage of responders who achieved and maintained confirmed HIV-1 RNA < 400 c/mL [defined by the TLOVR algorithm]) through Week 48 in the EFV+FTC+TDF group is no more than 13% worse than in the CBV+EFV group."|
1763496|NCT00111800|3237429|Superiority||Mean Difference (Net)|-0.04||||0.094|2-Sided|95.0|-0.09|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763497|NCT00111800|3237429|Superiority||Mean Difference (Net)|-0.06||||0.021|2-Sided|95.0|-0.11|-0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763498|NCT00111800|3237429|Superiority||Mean Difference (Net)|-0.04||||0.136|2-Sided|95.0|-0.09|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763499|NCT00111800|3237429|Superiority||Mean Difference (Net)|-0.02||||0.457|2-Sided|95.0|-0.07|0.03|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763500|NCT00111800|3237429|Superiority||Mean Difference (Net)|0.03||||0.286|2-Sided|95.0|-0.02|0.08|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763501|NCT00111800|3237432|Superiority||Mean Difference (Net)|2.75||||0.403|2-Sided|95.0|-3.71|9.22|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg for pro-insulin.|Placebo versus DEN 45 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763502|NCT00111800|3237432|Superiority||Mean Difference (Net)|-2.21||||0.504|2-Sided|95.0|-8.71|4.29|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg for pro-insulin.|Placebo versus DEN 30 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763503|NCT00111800|3237432|Superiority||Mean Difference (Net)|-0.35||||0.914|2-Sided|95.0|-6.7|6.0|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg for pro-insulin.|Placebo versus DEN 15 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763504|NCT00111800|3237432|Superiority||Mean Difference (Net)|3.06||||0.345|2-Sided|95.0|-3.31|9.44|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg for pro-insulin.|Placebo versus DEN 7.5 mg for pro-insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763576|NCT00110812|3237510|Superiority or Other||Mean Difference (Net)|0.54|||<|0.001|2-Sided|95.0|0.24|0.85|||ANOVA|Stratified by region and adjusted for baseline HIV-RNA|||
1763506|NCT00111800|3237432|Superiority||Mean Difference (Net)|12.74||||0.295|2-Sided|95.0|-11.18|36.65|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg for fasting serum insulin.|Placebo versus DEN 45 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763507|NCT00111800|3237432|Superiority||Mean Difference (Net)|5.27||||0.665|2-Sided|95.0|-18.64|29.17|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg for fasting serum insulin.|Placebo versus DEN 30 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763508|NCT00111800|3237432|Superiority||Mean Difference (Net)|7.31||||0.534||95.0|-15.79|30.42|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg for fasting serum insulin.|Placebo versus DEN 15 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763509|NCT00111800|3237432|Superiority||Mean Difference (Net)|14.18||||0.237|2-Sided|95.0|-9.37|37.72|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg for fasting serum insulin.|Placebo versus DEN 7.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763510|NCT00111800|3237432|Superiority||Mean Difference (Net)|-8.51||||0.489|2-Sided|95.0|-32.66|15.65|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg for fasting serum insulin.|Placebo versus DEN 2.5 mg for fasting serum insulin. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763511|NCT00111800|3237434|Superiority||Mean Difference (Net)|-38.9|||<|0.001|2-Sided|95.0|-53.8|-23.9|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763512|NCT00111800|3237434|Superiority||Mean Difference (Net)|-39.6|||<|0.001|2-Sided|95.0|-54.6|-24.6|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763513|NCT00111800|3237434|Superiority||Mean Difference (Net)|-29.2|||<|0.001||95.0|-43.9|-14.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763514|NCT00111800|3237434|Superiority||Mean Difference (Net)|-22.4|||<|0.003||95.0|-37.1|-7.6|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763515|NCT00111800|3237434|Superiority||Mean Difference (Net)|-14.9|||<|0.057||95.0|-30.2|0.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763516|NCT00111800|3237435|Superiority||Odds Ratio (OR)|3.0||||0.034|2-Sided|95.0|1.08|8.3|||Regression, Logistic|||Placebo versus DEN 45 mg for FPG reduction >=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763517|NCT00111800|3237435|Superiority||Odds Ratio (OR)|3.24||||0.026|2-Sided|95.0|1.15|9.13|||Regression, Logistic|||Placebo versus DEN 30 mg for FPG reduction >=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763518|NCT00111800|3237435|Superiority||Odds Ratio (OR)|1.35||||0.59|2-Sided|95.0|0.45|4.0|||Regression, Logistic|||Placebo versus DEN 15 mg for FPG reduction >=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763519|NCT00111800|3237435|Superiority||Odds Ratio (OR)|1.59||||0.396|2-Sided|95.0|0.55|4.62|||Regression, Logistic|||Placebo versus DEN 7.5 mg for FPG reduction >=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763520|NCT00111800|3237435|Superiority||Odds Ratio (OR)|1.9||||0.254|2-Sided|95.0|0.63|5.72|||Regression, Logistic|||Placebo versus DEN 2.5 mg for FPG reduction >=1.7 mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763521|NCT00111800|3237435|Superiority||Odds Ratio (OR)|3.14||||0.077|2-Sided|95.0|0.89|11.14|||Regression, Logistic|||Placebo versus DEN 45 mg for FPG <7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763522|NCT00111800|3237435|Superiority||Odds Ratio (OR)|1.56||||0.509|2-Sided|95.0|0.41|5.91|||Regression, Logistic|||Placebo versus DEN 30 mg for FPG <7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1764214|NCT00101686|3238686|Superiority or Other||Hazard Ratio (HR)|1.269||||0.2835||95.0|0.75|2.15|||Log Rank||||
1763523|NCT00111800|3237435|Superiority||Odds Ratio (OR)|1.09||||0.906|2-Sided|95.0|0.26|4.62|||Regression, Logistic|||Placebo versus DEN 15 mg for FPG <7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763524|NCT00111800|3237435|Superiority||Odds Ratio (OR)|2.57||||0.145|2-Sided|95.0|0.72|9.11|||Regression, Logistic|||Placebo versus DEN 7.5 mg for FPG <7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763525|NCT00111800|3237435|Superiority||Odds Ratio (OR)|1.77||||0.38|2-Sided|95.0|0.5|6.3|||Regression, Logistic|||Placebo versus DEN 2.5 mg for FPG <7mmol/L. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763526|NCT00111800|3237436|Superiority||Odds Ratio (OR)|2.0||||0.161|2-Sided|95.0|0.76|5.24|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c reduction >=0.7%. A closed test procedure was used,P an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763527|NCT00111800|3237436|Superiority||Odds Ratio (OR)|3.65||||0.008|2-Sided|95.0|1.41|9.48|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c reduction >=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763528|NCT00111800|3237436|Superiority||Odds Ratio (OR)|1.01||||0.991|2-Sided|95.0|0.36|2.78|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c reduction >=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763529|NCT00111800|3237436|Superiority||Odds Ratio (OR)|1.43||||0.481|2-Sided|95.0|0.53|3.85|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c reduction >=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763530|NCT00111800|3237436|Superiority||Odds Ratio (OR)|0.46||||0.198|2-Sided|95.0|0.14|1.5|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c reduction >=0.7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763531|NCT00111800|3237436|Superiority||Odds Ratio (OR)|3.24||||0.032|2-Sided|95.0|1.11|9.52|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c <7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763532|NCT00111800|3237436|Superiority||Odds Ratio (OR)|2.15||||0.152|2-Sided|95.0|0.76|6.13|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c <7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763533|NCT00111800|3237436|Superiority||Odds Ratio (OR)|1.04||||0.941|2-Sided|95.0|0.35|3.13|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c <7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763534|NCT00111800|3237436|Superiority||Odds Ratio (OR)|1.99||||0.202|2-Sided|95.0|0.69|5.76|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c <7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763535|NCT00111800|3237436|Superiority||Odds Ratio (OR)|1.1||||0.866|2-Sided|95.0|0.36|3.36|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c <7%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763536|NCT00111800|3237436|Superiority||Odds Ratio (OR)|3.24||||0.085|2-Sided|95.0|0.85|12.37|||Regression, Logistic|||Placebo versus DEN 45 mg for HbA1c <=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763537|NCT00111800|3237436|Superiority||Odds Ratio (OR)|2.68||||0.135|2-Sided|95.0|0.74|9.77|||Regression, Logistic|||Placebo versus DEN 30 mg for HbA1c <=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763538|NCT00111800|3237436|Superiority||Odds Ratio (OR)|1.2||||0.795|2-Sided|95.0|0.3|4.83|||Regression, Logistic|||Placebo versus DEN 15 mg for HbA1c <=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763539|NCT00111800|3237436|Superiority||Odds Ratio (OR)|1.15||||0.852|2-Sided|95.0|0.27|4.92|||Regression, Logistic|||Placebo versus DEN 7.5 mg for HbA1c <=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763540|NCT00111800|3237436|Superiority||Odds Ratio (OR)|0.92||||0.909|2-Sided|95.0|0.21|3.95|||Regression, Logistic|||Placebo versus DEN 2.5 mg for HbA1c <=6.5%. A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763541|NCT00111800|3237438|Superiority||Mean Difference (Net)|-1.22||||0.002|2-Sided|95.0|-1.99|-0.46|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763577|NCT00110812|3237510|Superiority or Other||Mean Difference (Net)|0.34|||<|0.03|2-Sided|95.0|0.03|0.64|||ANOVA|Stratified by region and adjusted for baseline HIV-RNA|||
1763542|NCT00111800|3237438|Superiority||Mean Difference (Net)|-1.46|||<|0.001|2-Sided|95.0|-2.23|-0.69|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763543|NCT00111800|3237438|Superiority||Mean Difference (Net)|-0.58|||<|0.13|2-Sided|95.0|-1.34|0.17|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763544|NCT00111800|3237438|Superiority||Mean Difference (Net)|-0.8|||<|0.039|2-Sided|95.0|-1.56|-0.04|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763545|NCT00111800|3237438|Superiority||Mean Difference (Net)|-0.4|||<|0.306|2-Sided|95.0|-1.18|0.37|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763546|NCT00111800|3237440|Superiority||Mean Difference (Net)|-0.84|||<|0.001|2-Sided|95.0|-1.13|-0.55|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 45 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763547|NCT00111800|3237440|Superiority||Mean Difference (Net)|-0.8|||<|0.001|2-Sided|95.0|-1.09|-0.5|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 30 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763548|NCT00111800|3237440|Superiority||Mean Difference (Net)|-0.45|||<|0.002|2-Sided|95.0|-0.74|-0.16|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 15 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763549|NCT00111800|3237440|Superiority||Mean Difference (Net)|-0.53|||<|0.001|2-Sided|95.0|-0.82|-0.24|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 7.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763550|NCT00111800|3237440|Superiority||Mean Difference (Net)|-0.28|||<|0.061|2-Sided|95.0|-0.58|0.01|||ANCOVA||The point estimate was calculated as least square mean difference (net values) of placebo and DEN 2.5 mg.|A closed test procedure was used, in an hierarchical manner, that is, test was applied sequentially where testing does not proceed to the next step unless the previous test was found to be significant.|
1763551|NCT00111761|3237446|Superiority or Other||Percentage of participants|47.4||||||95.0|24.4|71.1|||||||
1763552|NCT00111761|3237451|Superiority or Other||Percentage|33.3||||||95.0|15.6|55.3|||||||
1763553|NCT00111761|3237452|Superiority or Other||Percentage of participants|58.0||||||95.0|34.0|80.0|||||||
1763554|NCT00111761|3237453|Superiority or Other||Percentage of participants|25.0||||||95.0|9.8|46.7|||||||
1763555|NCT00111007|3237484|Superiority or Other|||||||0.389|||||||Fisher Exact||||
1763556|NCT00111007|3237485|Superiority or Other||Hazard Ratio (HR)|0.398||||0.146|2-Sided|95.0|0.11|1.437|||log rank test||||
1763557|NCT00111007|3237486|Superiority or Other||Hazard Ratio (HR)|0.863||||0.331|2-Sided|95.0|0.641|1.162|||log rank test||||
1763558|NCT00111007|3237487|Superiority or Other||Hazard Ratio (HR)|0.996||||0.979|2-Sided|95.0|0.744|1.333|||log rank test||||
1763559|NCT00111007|3237488|Superiority or Other||Hazard Ratio (HR)|0.906||||0.492|2-Sided|95.0|0.627|1.31|||log rank test||||
1763560|NCT00110994|3237489|Superiority or Other|||||||0.168|||||||t-test, 2 sided||||
1763561|NCT00110994|3237490|Superiority or Other|||||||0.201|||||||t-test, 2 sided||||
1763562|NCT00110994|3237491|Superiority or Other|||||||0.89|||||||t-test, 2 sided||||
1763563|NCT00110994|3237492|Superiority or Other|||||||0.908|||||||t-test, 2 sided||||
1763564|NCT00110994|3237494|Superiority or Other||Hazard Ratio (HR)|0.427||||0.194|2-Sided|95.0|0.114|1.601|||log rank test||||
1763565|NCT00110994|3237495|Superiority or Other||Hazard Ratio (HR)|0.619||||0.039|2-Sided|95.0|0.391|0.98|||log rank test||||
1763566|NCT00110994|3237497|Superiority or Other||Hazard Ratio (HR)|0.992||||0.973|2-Sided|95.0|0.627|1.57|||log rank test||||
1763567|NCT00110994|3237498|Superiority or Other||Hazard Ratio (HR)|0.665||||0.068|2-Sided|95.0|0.428|1.034|||log rank test||||
1763568|NCT00110890|3237499|Superiority or Other||Odds Ratio (OR)|1.88||||0.002||95.0|1.26|2.81|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg^2/dL^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg^2/dL^2||
1763569|NCT00110890|3237500|Superiority or Other||Odds Ratio (OR)|6.93|||<|0.001||95.0|4.65|10.34|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg^2/dL^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg^2/dL^2||
1763570|NCT00110890|3237501|Superiority or Other||Odds Ratio (OR)|3.11|||<|0.001||95.0|2.0|4.84|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg^2/dL^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg^2/dL^2||
1763571|NCT00110890|3237502|Superiority or Other||Odds Ratio (OR)|8.74|||<|0.001||95.0|5.38|14.19|||Cochran-Mantel-Haenszel|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg^2/dL^2|Adjusted for four baseline strata defined by vitamin D prescribed and calcium x phosphorus ≤ 55 mg^2/dL^2||
1763578|NCT00110812|3237511|Superiority or Other||Hazard Ratio (HR)|0.32|||<|0.001|2-Sided|95.0|0.17|0.62|||Regression, Cox||IL-2 with pericycle HAART compared to control||
1763579|NCT00110812|3237511|Superiority or Other||Hazard Ratio (HR)|0.58|||<|0.048|2-Sided|95.0|0.34|0.99|||Regression, Cox||IL-2 without ART vs control group||
1763580|NCT00110812|3237512|Superiority or Other||Hazard Ratio (HR)|6.56||||0.08|2-Sided|95.0|0.8|53.6|||Regression, Cox|Unadjusted, stratified by region.|Patients taking IL-2 plus pericycle HAART compared to patients not receiving IL-2||
1763581|NCT00110812|3237512|Superiority or Other||Hazard Ratio (HR)|5.08||||0.14|2-Sided|95.0|0.59|43.6|||Regression, Cox|Unadjusted, stratified by region.|Patients taking IL-2 alone compared to patients not taking IL-2.||
1763582|NCT00110812|3237515|Superiority or Other||Mean Difference (Net)|58.2||||0.02||95.0|||||ANOVA|stratified by region and adjusted for baseline CD4|||
1763583|NCT00110812|3237515|Superiority or Other||Mean Difference (Net)|65.8||||0.009||95.0|||||ANOVA|ANOVA with stratification by region and adjustment for baseline CD4|||
1763584|NCT00110812|3237516|Superiority or Other||Mean Difference (Net)|0.36||||0.003|2-Sided|95.0|0.12|0.6|||ANOVA|stratified by region and adjusted for baseline HIV-RNA.|||
1763585|NCT00110812|3237516|Superiority or Other||Mean Difference (Net)|0.31||||0.01|2-Sided|95.0|0.08|0.54|||ANOVA|stratified by region and adjusted for baseline HIV-RNA.|||
1763586|NCT00110812|3237518|Superiority or Other||Mean Difference (Net)|133.0|||<|0.001|2-Sided|95.0|68.0|199.0||Adjusted for 3 pairwise comparisons.|ANOVA|stratified by geographic region and adjusted for baseline CD4.|||
1763587|NCT00110812|3237518|Superiority or Other||Mean Difference (Net)|134.0|||<|0.001|2-Sided|95.0|70.0|198.0||Adjusted for 3 pairwise comparisons.|ANOVA|stratified by geographic region and adjusted for baseline CD4.|||
1763588|NCT00110461|3237524|Superiority or Other||Mean Difference (Final Values)|-0.79||||0.0001|2-Sided|95.0|-1.18|-0.4|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.|
1763589|NCT00110461|3237524|Superiority or Other||Mean Difference (Final Values)|-0.63||||0.003|2-Sided|95.0|-1.04|-0.22|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.|
1763590|NCT00110461|3237525|Superiority or Other||Mean Difference (Final Values)|-1.05|||<|0.0001|2-Sided|95.0|-1.39|-0.72|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.|
1763591|NCT00110461|3237525|Superiority or Other||Mean Difference (Final Values)|-0.99|||<|0.0001|2-Sided|95.0|-1.31|-0.67|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.|
1763592|NCT00110461|3237526|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.0113|2-Sided|95.0|-0.89|-0.12|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.|
1763593|NCT00110461|3237526|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.1726|2-Sided|95.0|-0.64|0.11|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.|
1763594|NCT00110461|3237527|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.0053|2-Sided|95.0|-0.85|-0.16|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.|
1763595|NCT00110461|3237527|Superiority or Other||Mean Difference (Final Values)|-0.61||||0.001|2-Sided|95.0|-0.96|-0.26|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.|
1763596|NCT00110461|3237528|Superiority or Other||Mean Difference (Final Values)|-0.8||||0.0001|2-Sided|95.0|-1.19|-0.41|||Cochran-Mantel-Haenszel||||
1763597|NCT00110461|3237528|Superiority or Other||Mean Difference (Final Values)|-0.64||||0.002|2-Sided|95.0|-1.04|-0.24|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.|
1763598|NCT00110461|3237529|Superiority or Other||Mean Difference (Final Values)|-1.05|||<|0.0001|2-Sided|95.0|-1.39|-0.7|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.|
1763599|NCT00110461|3237529|Superiority or Other||Mean Difference (Final Values)|-0.97|||<|0.0001|2-Sided|95.0|-1.29|-0.66|||Cochran-Mantel-Haenszel|||Analyzed using the Cochran-Mantel-Haenszel row mean score statistic by week.|
1763600|NCT00110461|3237530|Superiority or Other||Mean Difference (Final Values)|28.96|||<|0.0001|2-Sided|95.0|15.05|42.87|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.|
1763601|NCT00110461|3237530|Superiority or Other||Mean Difference (Final Values)|23.4|||<|0.0009|2-Sided|95.0|9.57|37.24|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.|
1763602|NCT00110461|3237531|Superiority or Other||Mean Difference (Final Values)|37.55|||<|0.0001|2-Sided|95.0|23.41|51.68|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.|
1763603|NCT00110461|3237531|Superiority or Other||Mean Difference (Final Values)|18.7|||<|0.0074|2-Sided|95.0|5.01|32.4|||Chi-squared|||Analyzed using a Chi-square test. Ninety five percent confidence intervals for difference in the responder rates are derived from the normal approximation to binomial.|
1763604|NCT00110461|3237532|Superiority or Other||Mean Difference (Final Values)|-5.55||||0.0014|2-Sided|95.0|-8.94|-2.16|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763605|NCT00110461|3237532|Superiority or Other||Mean Difference (Final Values)|-7.05|||<|0.0001|2-Sided|95.0|-10.5|-3.64|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763606|NCT00110461|3237533|Superiority or Other||Mean Difference (Final Values)|-1.21||||0.2101|2-Sided|95.0|-3.09|0.68|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763607|NCT00110461|3237533|Superiority or Other||Mean Difference (Final Values)|-0.82||||0.3969|2-Sided|95.0|-2.71|1.08|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763608|NCT00110461|3237534|Superiority or Other||Mean Difference (Final Values)|0.19||||0.8377|2-Sided|95.0|-1.61|1.98|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763609|NCT00110461|3237534|Superiority or Other||Mean Difference (Final Values)|0.07||||0.9418|2-Sided|95.0|-1.73|1.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763610|NCT00110461|3237535|Superiority or Other||Mean Difference (Final Values)|0.19||||0.19|2-Sided|95.0|-1.67|1.98|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763611|NCT00110461|3237535|Superiority or Other||Mean Difference (Final Values)|0.07||||0.9418|2-Sided|95.0|-1.73|1.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763612|NCT00110461|3237536|Superiority or Other||Mean Difference (Final Values)|-0.31||||0.7696|2-Sided|95.0|-2.37|1.76|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763613|NCT00110461|3237536|Superiority or Other||Mean Difference (Final Values)|-2.13||||0.043|2-Sided|95.0|-4.2|-0.07|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763614|NCT00110461|3237537|Superiority or Other||Mean Difference (Final Values)|-2.64||||0.0058|2-Sided|95.0|-4.51|-0.77|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763615|NCT00110461|3237537|Superiority or Other||Mean Difference (Final Values)|-1.44||||0.1309|2-Sided|95.0|-3.31|0.43|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763616|NCT00110461|3237538|Superiority or Other||Mean Difference (Final Values)|-2.03||||0.0296|2-Sided|95.0|-3.85|-0.2|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763617|NCT00110461|3237538|Superiority or Other||Mean Difference (Final Values)|-1.85||||0.0468|2-Sided|95.0|-3.67|-0.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763618|NCT00110461|3237539|Superiority or Other||Mean Difference (Final Values)|-4.64|||<|0.0001|2-Sided|95.0|-6.78|-2.5|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763619|NCT00110461|3237539|Superiority or Other||Mean Difference (Final Values)|-4.76|||<|0.0001|2-Sided|95.0|-6.9|-2.61|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763620|NCT00110461|3237540|Superiority or Other||Median Difference (Final Values)|-0.43||||0.75586|2-Sided|95.0|-3.17|2.31|||t-test, 2 sided||||
1763621|NCT00110461|3237540|Superiority or Other||Median Difference (Final Values)|-1.92||||0.1729|2-Sided|95.0|-4.69|0.85|||t-test, 2 sided||||
1763622|NCT00110461|3237541|Superiority or Other||Mean Difference (Final Values)|-0.97|||<|0.0001|2-Sided|95.0|-1.33|-0.6|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763623|NCT00110461|3237541|Superiority or Other||Mean Difference (Final Values)|-0.76|||<|0.0001|2-Sided|95.0|-1.13|-0.4|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763624|NCT00110461|3237542|Superiority or Other||Median Difference (Final Values)|-1.18|||<|0.0001|2-Sided|95.0|-1.51|-0.86|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763765|NCT00107042|3237869|Superiority or Other||Odds Ratio (OR)|1.18||||1|2-Sided|95.0|0.0|10.01|||Univariate regression, Logistic||"The reference group is the 0 Partners group"||
1764488|NCT00095498|3239350|Superiority or Other||||||<|0.001|||||||van Elteren Stratified Rank Test||||
1763625|NCT00110461|3237542|Superiority or Other||Mean Difference (Final Values)|-0.83|||<|0.0001|2-Sided|95.0|-1.16|-0.51|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763626|NCT00110461|3237543|Superiority or Other||Mean Difference (Final Values)|-0.39||||0.0166|2-Sided|95.0|-0.71|-0.07|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763627|NCT00110461|3237543|Superiority or Other||Mean Difference (Final Values)|-0.19||||0.2553|2-Sided|95.0|-0.51|0.13|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763628|NCT00110461|3237544|Superiority or Other||Median Difference (Final Values)|-0.26||||0.0752|2-Sided|95.0|-0.55|0.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763629|NCT00110461|3237544|Superiority or Other||Mean Difference (Final Values)|-0.25||||0.0878|2-Sided|95.0|-0.54|0.04|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763630|NCT00110461|3237545|Superiority or Other||Median Difference (Final Values)|-1.04|||<|0.0001|2-Sided|95.0|-1.41|-0.66|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763631|NCT00110461|3237545|Superiority or Other||Median Difference (Final Values)|-0.7|||<|0.0003|2-Sided|95.0|-1.08|-0.33|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763632|NCT00110461|3237546|Superiority or Other||Median Difference (Final Values)|10.0|||<|0.0001|2-Sided|95.0|5.87|14.14|||t-test, 2 sided||||
1763633|NCT00110461|3237546|Superiority or Other||Mean Difference (Final Values)|9.23|||<|0.0001|2-Sided|95.0|5.07|13.93|||t-test, 2 sided||||
1763634|NCT00110461|3237547|Superiority or Other||Mean Difference (Final Values)|-8.23|||<|0.0001|2-Sided|95.0|-11.6|-4.83|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763635|NCT00110461|3237547|Superiority or Other||Mean Difference (Final Values)|-8.86|||<|0.0001|2-Sided|95.0|-12.3|-5.43|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor, and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763636|NCT00110461|3237548|Superiority or Other||Mean Difference (Final Values)|-5.46|||<|0.0001|2-Sided|95.0|-7.4|-3.32|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763637|NCT00110461|3237548|Superiority or Other||Mean Difference (Final Values)|-5.88|||<|0.0001|2-Sided|95.0|-8.02|-3.73|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763638|NCT00110461|3237549|Superiority or Other||Mean Difference (Final Values)|-1.19||||0.3515|2-Sided|95.0|-3.69|1.32|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763639|NCT00110461|3237549|Superiority or Other||Mean Difference (Final Values)|-2.28||||0.0767|2-Sided|95.0|-4.81|0.25|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763640|NCT00110461|3237550|Superiority or Other||Mean Difference (Final Values)|-1.26|||<|0.0001||95.0|-1.59|-0.93|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763641|NCT00110461|3237550|Superiority or Other||Mean Difference (Final Values)|-0.81|||<|0.0001|2-Sided|95.0|-1.15|-0.48|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763642|NCT00110461|3237551|Superiority or Other||Median Difference (Final Values)|11.51|||<|0.0001|2-Sided|95.0|7.99|15.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763766|NCT00107042|3237869|Superiority or Other||Odds Ratio (OR)|0.015||||0.0003|2-Sided|95.0|0.0|0.19|||Univariate regression, logistic||"The reference group is hte 0 Partners group."||
1763643|NCT00110461|3237551|Superiority or Other||Median Difference (Final Values)|9.3|||<|0.0001|2-Sided|95.0|5.77|12.84|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763644|NCT00110461|3237552|Superiority or Other||Median Difference (Final Values)|11.51|||<|0.0001|2-Sided|95.0|7.99|15.03|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763645|NCT00110461|3237552|Superiority or Other||Median Difference (Final Values)|-5.89|||<|0.0001|2-Sided|95.0|-8.7|-3.08|||t-test, 2 sided|||Analyses were performed by fitting an ANCOVA model with treatment as factor and baseline score as covariate. Two pair-wise comparisons, aripiprazole 10 mg target dose versus placebo and aripiprazole 30 mg target dose versus placebo, were performed within the ANCOVA or ANOVA model.|
1763646|NCT00110461|3237553|Superiority or Other||Median Difference (Final Values)|-8.26|||<|0.0001|2-Sided|95.0|-10.7|-5.77|||t-test, 2 sided|||The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student’s t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.|
1763647|NCT00110461|3237553|Superiority or Other||Mean Difference (Final Values)|-5.99|||<|0.0001|2-Sided|95.0|-8.49|-3.5|||t-test, 2 sided|||The change scores were analyzed by using ANCOVA model with treatment as a factor and baseline Y-MRS total score as a covariate. For comparing YMRS-Total score in treatment groups at baseline, only treatment was included in the ANOVA model with baseline values as the dependent variable. The LS means obtained from a type III analysis using SAS were used for the treatment comparisons. Two-tailed student’s t-tests were used to test differences between the LS means within the ANCOVA or ANOVA model.|
1763648|NCT00110305|3237581|Superiority or Other||Difference in response rate|-2.8||||||95.0|-14.7|9.1|||||||
1763649|NCT00110305|3237583|Superiority or Other||Differences in response|2.6||||0.63|2-Sided|95.0|-8.1|13.3||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.|||
1763650|NCT00110305|3237583|Superiority or Other||Difference in response rate|0.0||||0.99|2-Sided|95.0|-12.9|12.8||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.|||
1763651|NCT00110305|3237583|Superiority or Other||Difference in response rate|-4.8||||0.45|2-Sided|95.0|-17.3|7.7||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.|||
1763652|NCT00110305|3237583|Superiority or Other||Difference in response rate|-4.8||||0.45|2-Sided|95.0|-17.1|7.6||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and Nucleoside/tide reverse transcriptase inhibitors (N[t]RTIs) used, and baseline viral load as covariate.|||
1763653|NCT00110305|3237584|Superiority or Other||Difference in response rate|-1.5||||0.8|2-Sided|95.0|-10.5|7.5||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.|||
1763654|NCT00110305|3237584|Superiority or Other||Difference in response rate|-2.8||||0.62|2-Sided|95.0|-14.0|8.4||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.|||
1763655|NCT00110305|3237584|Superiority or Other||Difference in response rate|-2.3||||0.56|2-Sided|95.0|-13.6|9.0||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and N(t)RTIs used, and baseline viral load as covariate.|||
1763656|NCT00110305|3237584|Superiority or Other||Differences in response rate|0.5||||0.92|2-Sided|95.0|-10.4|11.3||The significance level for each comparison was 5% (two-sided). No further adjustment of this significance level was applied.|Regression, Logistic|This model with factors treatment, region, and Nucleoside/tide reverse transcriptase inhibitors (N[t]RTIs) used, and baseline viral load as covariate.|||
1763657|NCT00110214|3237586|Superiority or Other||Hazard Ratio (HR)|0.8|||<|0.001|2-Sided|95.0|0.71|0.91||The primary analysis was adjusted for the stratification factors (24-mo survival probability as predicted by a validated nomogram (<10%,10%-29.9%,>=30%), age (<65, >=65 years) and prior history of arterial events (yes, no)).|Log Rank||||
1763658|NCT00110214|3237587|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1763659|NCT00110214|3237588|Non-Inferiority or Equivalence|Superiority and futility analyses were conducted for the OS end point. The Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain the overall significance level of alpha=0.05 while conducting interim analyses on OS. The final analysis was performed when 748 deaths had been observed. An intention-to-treat approach was used in the analysis for all the clinical end points with the exception of toxicity.|Hazard Ratio (HR)|0.91||||0.181|2-Sided|95.0|0.7|1.05||The primary analysis was adjusted for the stratification factors (24-mo survival probability as predicted by a validated nomogram (<10%,10%-29.9%,>=30%), age (<65, >=65 years) and prior history of arterial events (yes, no)).|Log Rank||||
1763660|NCT00110149|3237590|Other|As the study was not able to be completed the simple number of patients per outcome is listed.|||||||||||||||||The trial was to measure the response rate and EFS of patients but the manufacturer of the investigational agent closed and sold the agent to a new company so the trial was not able to be completed.
1764215|NCT00101686|3238687|Superiority or Other||Hazard Ratio (HR)|1.08||||0.5316||95.0|0.86|1.36|||Log Rank||||
1763661|NCT00110136|3237591|Superiority or Other||Mean Difference (Final Values)|4.35|Standard Deviation|7.12||0.1042|2-Sided|95.0|-1.12|9.822||Paired t-test; unadjusted for multiple comparisons.|paired t-test||This is the change in mood from baseline to four weeks (post minus pre). Mood is scored so that higher numbers represent better mood so positive changes represent an improvement in mood.|Assess the change in mood from baseline to four weeks. Null hypothesis is no change.|
1763662|NCT00110136|3237592|Superiority or Other||Mean Difference (Final Values)|0.0|Standard Deviation|7.43||0.9995|2-Sided|95.0|-5.71|5.71||Paired t-test on the change in PCS from baseline to four weeks; unadjusted for multiple comparisons.|paired t-test||This is the change in PCS from baseline to four weeks (post minus pre), so positive numbers represent improvement in QOL.|Assess the change in PCS from baseline to four weeks; null hypothesis is no change.|
1763663|NCT00110136|3237593|Superiority or Other||Mean Difference (Final Values)|0.54|Standard Deviation|7.0||0.832|2-Sided|95.0|-4.84|5.92||Paired t-test; unadjusted for multiple comparisons.|paired t-test||This is the change in MCS from baseline to four weeks (post minus pre) so values greater than zero reflect improvement in QOL.|Assess the change in MCS from baseline to four weeks in patients receiving St. John's wort.|
1763664|NCT00110136|3237595|Superiority or Other||Mean Difference (Final Values)|-4.37|Standard Deviation|7.91||0.1365|2-Sided|95.0|-10.45|1.72||Paired t-test; unadjusted for multiple comparisons.|paired t-test||Difference in hot flash score is post minus pre so a negative value represents a decrease in the frequency and/or severity of the hot flashes.|Assessment of the change in the hot flash score over time|
1763665|NCT00110136|3237596|Superiority or Other||Mean Difference (Final Values)|-0.81|Standard Deviation|2.02||0.2629|2-Sided|95.0|-2.36|0.74||Paired t-test; no adjustments for multiple comparisons|paired t-test||The difference is post minus pre so negative values represents fewer hot flashes after treatment.|Analysis of the change in hot flash frequency from baseline to four weeks; null hypothesis is no change.|
1763666|NCT00110084|3237600|Superiority or Other||Proportion of confirmed responses (%)|50.0|||||2-Sided|95.0|36.0|64.0|||||95% Confidence intervals were calculated for the true confirmed response rate using properties of the binomial distribution.|Proportion of confirmed responses was estimated by the number of patients who achieved a confirmed response divided by the total number of assessable patients.|
1763667|NCT00110019|3237601|Superiority or Other|||||||0.427||||||priori threshold for statistical significance: P<0.05|Fisher Exact||||
1763668|NCT00110019|3237602|Superiority or Other||Hazard Ratio (HR)|0.9||||0.092|2-Sided|95.0|0.78|1.03||priori threshold for statistical significance: P<0.05|Log Rank|Stratified log rank test is used for progression-free survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status|Arm II is the reference group||
1763669|NCT00110019|3237603|Superiority or Other||Hazard Ratio (HR)|1.01||||0.863|2-Sided|95.0|0.87|1.18|||Log Rank|Stratified log rank test is used for overall survival comparison, stratified on AJCC stage, ECOG Performance status and prior therapy status|Arm II is the reference group||
1763670|NCT00109837|3237625|Superiority or Other||Proportion in 1-year CCR|0.36|Standard Deviation|0.06|||1-Sided|95.0|0.25|||||||The regimen would be of no further interest if the true 1-year continuous complete remission (CCR) rate was less than 45% (null). Sample size was chosen for an alternative of 65%, power of 92% and type-1 error of 4.6%.|
1763671|NCT00109772|3237642|Superiority or Other|||||||0.894|||||||Cochran-Mantel-Haenszel|controlled for centers|||
1763672|NCT00109733|3237643|Superiority or Other|||||||0.044|||||||ANOVA|||"The null hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."|
1763673|NCT00109733|3237643|Superiority or Other|||||||0.041|||||||ANOVA|||"The null hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk to limb fat ratio from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."|
1763674|NCT00109733|3237644|Superiority or Other||||||<|0.001|||||||ANOVA|||"The null hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."|
1763675|NCT00109733|3237644|Superiority or Other||||||<|0.755|||||||ANOVA|||"The null hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in limb fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."|
1763676|NCT00109733|3237645|Superiority or Other|||||||0.002|||||||ANOVA|||"The null hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."|
1763677|NCT00109733|3237645|Superiority or Other|||||||0.653|||||||ANOVA|||"The null hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in total body fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."|
1763678|NCT00109733|3237646|Superiority or Other||||||<|0.001|||||||ANOVA|||"The null hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."|
1763679|NCT00109733|3237646|Superiority or Other||||||<|0.004|||||||ANOVA|||"The null hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in lean body mass (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."|
1763680|NCT00109733|3237647|Superiority or Other|||||||0.004|||||||ANOVA|||"The null hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."|
1763681|NCT00109733|3237647|Superiority or Other|||||||0.177|||||||ANOVA|||"The null hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group = 0) was tested against the alternative hypothesis (% change in trunk fat (kg) from baseline to Wk24 within the treatment group ≠0).~P-Values for testing this hypothesis for each treatment group are from an analysis of variance (ANOVA) model on ranked data with effects for treatment group, gender and their interaction."|
1763682|NCT00109590|3237657|Superiority or Other|||||||0.048||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P<0.05.|Wilcoxon Signed Rank Test|||The null hypothesis was that there was no difference in within-subject C4hour LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum|
1763683|NCT00109590|3237657|Superiority or Other|||||||0.009||||||The p-value was not adjusted for multiple comparisons. The a priori threshold for statistical significance was two-sided P<0.05.|wilcoxon Signed Rank Test|||The null hypothesis was that there was no difference in within-subject Cpredose LPV/r plasma drug concentrations within 72 hours after delivery versus at 30 days postpartum.|
1763684|NCT00109473|3237668|Superiority or Other||Mean Difference (Final Values)|14.0||||0.02|2-Sided|95.0|||||Mixed Models Analysis||||
1763685|NCT00108953|3237707|Superiority or Other||Hazard Ratio (HR)|0.65||||0.038||95.0|0.4|1.05|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups|
1763686|NCT00108953|3237709|Superiority or Other||Hazard Ratio (HR)|0.61||||0.018||95.0|0.45|0.83|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups|
1763687|NCT00108953|3237710|Superiority or Other||Hazard Ratio (HR)|0.52||||0.007||95.0|0.37|0.74|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups|
1763688|NCT00108953|3237711|Superiority or Other||Hazard Ratio, log|0.6||||0.016||95.0|0.33|0.95|||Log Rank||Hazard ratio: nexavar+doxorubicin over placebo+doxorubicin|The comparison between the 2 groups is done using the log rank test stratified by tumor burden. The null hypothesis is: TTP is the same in both treatment groups.|
1763689|NCT00108862|3237721|Superiority or Other||Mean Difference (Final Values)|-1.0|Standard Error of the Mean|3.0||0.67|2-Sided|95.08|-7.0|4.0||Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided||The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|The study was not powered for this pre-specified subgroup analysis.|
1763690|NCT00108862|3237722|Superiority or Other||Mean Difference (Final Values)|11.0|Standard Error of the Mean|5.0||0.02|2-Sided|95.08|2.0|21.0||Interim reviews employed group sequential monitoring using an > O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided||The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|The study was not powered for this pre-specified subgroup analysis.|
1763691|NCT00108862|3237723|Superiority or Other||Mean Difference (Final Values)|3.0|Standard Error of the Mean|3.0||0.45|2-Sided|95.08|-2.0|8.0||The analysis was stratified by screening CD4 (<50 cells/mm3 vs =>50). Interim reviews employed group sequential monitoring using an O'Brien-Fleming use function. At final analysis, the a priori threshold for statistical significance was 0.0492.|Z-test, 2-sided|A 2-sided Z-test was used to compare the two percents. The test was weighted by the inverse of the Greenwood's variance in each CD4 stratum.|The difference in percents was calculated as the percent failed in the Deferred ART arm minus the percent failed in the Immediate ART arm.|Assuming that immediate ART was better than deferred ART and that the combined rate in the deferred ART arm was 25% compared to 15% in the immediate ART arm (a 40% reduction), and assuming 10% loss to follow-up in a two-sided, two-sample 0.05-level asymptotically-normal test with 400 participants in each arm, there was 90% power. The percents tested were Kaplan-Meier estimators at week 48 with the associated Greenwood's variance.|
1763692|NCT00108732|3237724|Superiority or Other||median of difference|-0.04||||0.02||95.0||||The Wilcoxon signed-rank test was used to test the difference between pre and post-treatment PSA slopes assessed by multiple PSA values on natural log scale using a piecewise linear model with a common knot point at the date of registration.|Wilcoxon signed rank test||||
1763693|NCT00108732|3237725|Superiority or Other||median of difference|0.45||||0.003||95.0|||||Wilcoxon signed rank test|The Wilcoxon signed rank test was used to test the difference between day 4 PSA and day 15 PSA.|||
1763694|NCT00108732|3237726|Superiority or Other||Response rate (percent)|0.0|||||2-Sided|90.0|0.0|7.2|||||||
1763695|NCT00108732|3237727|Superiority or Other||Percent|62.5|||||2-Sided|90.0|48.3|75.3|||||||
1763696|NCT00108550|3237738|Superiority or Other||Mean Difference (Final Values)|-0.5343|Standard Error of the Mean|0.7174||0.458|2-Sided|95.0|-1.94|0.872||Primary analyses was multivariable linear regression with fixed and random effects. After the Bonferroni adjustment a p-value would have been considered significant at 0.05 level if <0.01.|Mixed Models Analysis|||This is a secondary analysis; the null hypothesis is that Gabapentin performs no better than placebo in reducing the Roland and Morris score.|
1764216|NCT00101686|3238688|Superiority or Other|||||||0.1559|||||||Cochran-Mantel-Haenszel||||
1763697|NCT00108550|3237739|Superiority or Other||Mean Difference (Final Values)|0.0305|Standard Error of the Mean|0.038||0.4237|2-Sided|95.0|-0.044|0.105||There was no need for multiple comparisons adjustment for the primary outcome, since there was only one. However, secondary analyses were adjusted for multiple comparisons.|Mixed Models Analysis|Effect of covariates (age, gender, etc) was evaluated (modeled as fixed effects) in secondary analyses.|The analysis was performed on transformed (rather than raw) Descriptor Differential Score Pain Intensity scores.|The null hypothesis was that Gabapentin is no better than placebo in reducing back pain. A mean-matching variance stabilizing transformation was applied to Descriptor Differential Scale Pain intensity (DDS) scores. Scores were modeled as a function of time (week) and group (gabapentin, placebo) in a mixed effects model. Random (subject-specific)intercept and slopes were fitted to the data. With alpha = .05 and N = 65 per group power is .8 to detect effect size =.4 standard deviations (SD).|
1763698|NCT00108355|3237750|Superiority or Other||||||<|0.05|||||||Log Rank|||Initial estimation: median time to recurrence of ascites of 38 days in the study group and 20 days in the control group in a fixed duration of 6 months (5% type-I error (2 sided) and an 80% power). However, due to low accrual and based on randomized trials using vasoconstrictors in the prevention of PCD and a study that showed that midodrine leads to a significant improvement in effective arterial blood volume, each of which had sample sizes of 24-25 patients,we decided on a sample size of 30.|
1763699|NCT00108303|3237753|Superiority or Other|||||||0.001|||||||Firsher's transform r to Z|||The coefficient of segregation versus no segregation of the P50 sensory gating percent in families with schizophrenia.|
1763700|NCT00108303|3237754|Superiority or Other||||||<|0.001||||||This parameter was estimated by simulating 1000 samples with random genotypes and finding no value equal to or greater than 5.2.|Simulation||||
1763701|NCT00108303|3237754|Superiority or Other||Log (odd ratio)|5.2|||<||2-Sided||||||||||
1763702|NCT00108160|3237758|Superiority or Other|||||||0.356||||||No adjustments were made for multiple comparisons.|Chi-squared|||Our null hypothesis was that no significant effect of mupirocin ointment (treatment) on S. aureus re-infection would be seen at 18 months compared with placebo ointment. Based on prior studies, we estimated that 198 participants would need to be enrolled assuming a 20% dropout rate; 84 participants per arm would be required to detect a 66% decrease in re-infection from 30% to 10% with a significance level alpha of 0.05 and a power of 0.9.|
1763703|NCT00108082|3237772|Superiority or Other||Mean Difference (Final Values)|1.6||||0.1711||95.0|-0.7|3.9|||ANCOVA||||
1763704|NCT00108082|3237772|Superiority or Other||Mean Difference (Final Values)|0.33||||0.7651||95.0|-1.83|2.49|||ANCOVA|||The null hypotheses (tested hierarchically) were that the effect of carvedilol CR + lisinopril on LV mass regression was no different than the effect of atenolol + lisinopril, and that the effect of carvedilol CR + lisinopril was no different than the effect of lisinopril + lisinopril. The primary analysis was based on an analysis of covariance (ANCOVA) with a model adjusting for treatment, stratification by hypertension class, region, and baseline value, at a 0.05 level of significance.|
1763705|NCT00107978|3237781|Non-Inferiority or Equivalence|Non-inferiority margin of 10% was specified based on historical regulatory precedent.|Risk Difference (RD)|2.5||||||95.0|-2.9|7.9|||||||
1763706|NCT00107952|3237782|Non-Inferiority or Equivalence|Non-inferiority margin of 20% was specified based on historical regulatory precedent.|Risk Difference (RD)|-1.6||||||95.0|-8.6|5.5|||||"Statistical analysis applies to cure"||
1763707|NCT00107900|3237786|Superiority or Other|||||||0.238|||||||Fisher Exact||||
1763708|NCT00107653|3237798|Superiority or Other||Study Group Difference|-1.23|Standard Error of the Mean|0.888||0.1653|2-Sided|95.0|-2.98|0.51|||ANCOVA||The estimated value is the difference of change from baseline in standardized mental component score at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Mental Component of Latino VS Non-Latino White at week 72|
1763709|NCT00107653|3237798|Superiority or Other||Study Group Difference|-0.08|Standard Error of the Mean|0.914||0.9286|2-Sided|95.0|-1.88|1.71|||ANCOVA||The estimated value is the difference of change from baseline in standardized mental component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Mental Component of Latino VS Non-Latino White at week 48|
1763710|NCT00107653|3237798|Superiority or Other||Study Group Difference|0.1|Standard Error of the Mean|0.808||0.9047|2-Sided|95.0|-1.49|1.68|||ANCOVA||The estimated value is the difference of change from baseline in standardized physical component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Physical Component of Latino VS Non-Latino White at week 72|
1763711|NCT00107653|3237798|Superiority or Other||Study Group Difference|3.49|Standard Error of the Mean|0.864|<|0.0001|2-Sided|95.0|1.79|5.18|||ANCOVA||The estimated value is the difference of change from baseline in standardized physical component score at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|Standardized Physical Component of Latino VS Non-Latino White at week 48|
1763712|NCT00107653|3237799|Superiority or Other||Study Group Difference|4.83|Standard Error of the Mean|2.37||0.0421|2-Sided|95.0|0.18|9.49|||ANCOVA||The estimated value is the difference of change from baseline in FSS VAS scores at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS VAS Score of Latino VS Non-Latino White at week 72|
1763713|NCT00107653|3237799|Superiority or Other||Study Group Difference|-8.72|Standard Error of the Mean|2.725||0.0015|2-Sided|95.0|-14.07|-3.36|||ANCOVA||The estimated value is the difference of change from baseline in FSS VAS scores at week 48 between Latino and Non-Latino White participants The 95% Confidence Interval is based on normal approximation to the binomial.|FSS VAS Score of Latino VS Non-Latino White at week 48|
1763714|NCT00107653|3237799|Superiority or Other||Study Group Difference|-0.26|Standard Error of the Mean|0.156||0.0921|2-Sided|95.0|-0.57|0.04|||ANCOVA||The estimated value is the difference of change from baseline in FSS scores at week 72 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS Score of Latino VS Non-Latino White at week 72|
1763767|NCT00107042|3237870|Superiority or Other||Odds Ratio (OR)|1.65||||0.6893||95.0|||||Univariate regression, Logistic||"The reference group is the 0 partners group.~Two sided 95% confidence interval: Lower Limit = 0.17; upper limit = infinity"||
1763715|NCT00107653|3237799|Superiority or Other||Study Group Difference|-0.65|Standard Error of the Mean|0.162|<|0.0001|2-Sided|95.0|-0.96|-0.33|||ANCOVA||The estimated value is the difference of change from baseline in FSS scores at week 48 between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|FSS Score of Latino VS Non-Latino White at week 48|
1763716|NCT00107653|3237808|Superiority or Other||Study Group Difference|0.9|Standard Error of the Mean|0.2|<|0.0001|2-Sided|95.0|0.5|1.3|||Normal approximation to the binomial.||The estimated value is the difference in change from baseline of ISHAK HAI activity (necroinflammatory) scores between Latino and Non-Latino White participants. The 95% Confidence Interval is based on normal approximation to the binomial.|ISHAK HAI activity For Latino VS Non-Latino White|
1763717|NCT00107653|3237809|Superiority or Other||Study Group Difference|-0.12|Standard Error of the Mean|0.05||0.0285|2-Sided|95.0|-0.2|0.0|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with ISHAK HAI response. The 95% Confidence Interval is based on normal approximation to the binomial.|ISHAK HAI Response For Latino VS Non-Latino White|
1763718|NCT00107653|3237810|Superiority or Other||Study Group Difference|-0.19|Standard Error of the Mean|0.041|<|0.0001|2-Sided|95.0|-0.27|-0.11|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 72|
1763719|NCT00107653|3237810|Superiority or Other||Study Group Difference|-0.18|Standard Error of the Mean|0.041|<|0.0001|2-Sided|95.0|-0.26|-0.1|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 60|
1763720|NCT00107653|3237810|Superiority or Other||Study Group Difference|-0.14|Standard Error of the Mean|0.042|<|0.0008|2-Sided|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 48|
1763721|NCT00107653|3237810|Superiority or Other||Study Group Difference|-0.15|Standard Error of the Mean|0.041|<|0.0003|2-Sided|95.0|-0.23|-0.07|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 24|
1763722|NCT00107653|3237810|Superiority or Other||Study Group Difference|-0.16|Standard Error of the Mean|0.04|<|0.0001|2-Sided|95.0|-0.24|-0.08|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 12|
1763723|NCT00107653|3237810|Superiority or Other||Study Group Difference|-0.14|Standard Error of the Mean|0.042|<|0.0006|2-Sided|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with biochemical response. The 95% Confidence Interval is based on normal approximation to the binomial.|Normal Serum ALT level for Latino VS Non-Latino White at Week 4|
1763724|NCT00107653|3237812|Superiority or Other||Study Group Difference|-0.11|Standard Error of the Mean|0.033||0.0014|2-Sided|95.0|-0.17|-0.04|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 12|
1763725|NCT00107653|3237813|Superiority or Other||Study Group Difference|-0.08|Standard Error of the Mean|0.036||0.0353|2-Sided|95.0|-0.15|-0.01|||Normal approximation to the binomial.||The estimated value is the Difference in proportion of participants (Latino minus Non-Latino White) with virologic response. the 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 4|
1763726|NCT00107653|3237814|Superiority or Other||Study Group Difference|-0.16|Standard Error of the Mean|0.041|<|0.0001|2-Sided|95.0|-0.24|-0.08|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 72|
1763727|NCT00107653|3237814|Superiority or Other||Study Group Difference|-0.17|Standard Error of the Mean|0.041|<|0.0001|2-Sided|95.0|-0.25|-0.09|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 60|
1763728|NCT00107653|3237814|Superiority or Other||Study Group Difference|-0.17|Standard Error of the Mean|0.04|<|0.0001|2-Sided|95.0|-0.24|-0.09|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 48|
1763729|NCT00107653|3237814|Superiority or Other||Study Group Difference|-0.14|Standard Error of the Mean|0.039|<|0.0004|2-Sided|95.0|-0.22|-0.06|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 24|
1763730|NCT00107653|3237814|Superiority or Other||Study Group Difference|-0.15|Standard Error of the Mean|0.041|<|0.0003|2-Sided|95.0|-0.23|-0.07|||Normal approximation to the binomial.||The estimated value is the Difference in proportion of participants (Latino minus Non-Latino White) with virologic response. the 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 12|
1763731|NCT00107653|3237814|Superiority or Other||Study Group Difference|-0.06|Standard Error of the Mean|0.031|<|0.0454|2-Sided|95.0|-0.12|0.0|||Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with virologic response. The 95% Confidence Interval is based on normal approximation to the binomial.|Virologic Response for Latino VS Non-Latino White at Week 4|
1763732|NCT00107653|3237815|Superiority or Other||SVR for Study Group Difference|-0.16|Standard Error of the Mean|0.041|<|0.0001|2-Sided|95.0|-0.24|-0.08||P-values are calculated based on the difference in proportion between Latino and Non-Latino White group|Normal approximation to the binomial.||The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with SVR. The 95% Confidence Interval is based on normal approximation to the binomial.|SVR for Latino Versus (VS) Non-Latino White|
1763733|NCT00107575|3237817|Superiority or Other|||||||0.76|||||||Chi-squared||||
1763734|NCT00107575|3237818|Superiority or Other|||||||0.95|||||||Chi-squared||||
1763735|NCT00107575|3237819|Superiority or Other|||||||0.18|||||||Chi-squared||||
1763736|NCT00107575|3237820|Superiority or Other||expected count ratio|0.81||||0.027|2-Sided|95.0|0.67|0.98||a priori p-value was p < .05|generalized estimating equations|Negative binomial model controlling for sex, motivation to change drinking, and baseline drinking|||
1763737|NCT00107575|3237821|Superiority or Other||||||>|0.05|||||||Chi-squared||||
1763738|NCT00107172|3237844|Superiority or Other (legacy)|||||||0.16|||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR + BX arm.|
1763739|NCT00107172|3237844|Superiority or Other (legacy)|||||||0.38|||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR arm.|
1763740|NCT00107172|3237845|Superiority or Other (legacy)|||||||0.18|||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR + BX arm.|
1763741|NCT00107172|3237845|Superiority or Other (legacy)|||||||0.03|||||||Wilcoxon Signed Rank|||Compare the percentage change from baseline to 3-month value for SR arm.|
1763742|NCT00107172|3237848|Superiority or Other (legacy)|||||||0.31|||||||Fisher Exact|||Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 90 between arms.|
1763743|NCT00107172|3237848|Superiority or Other (legacy)|||||||0.35|||||||Fisher Exact|||Compare the grade 3+ respiratory adverse events incidence reported from day 0 to 30 between arms.|
1763744|NCT00107172|3237849|Superiority or Other (legacy)|||||||0.25|||||||Fisher Exact|||Compare the grade 3+ adverse events incidence reported from day 0 to 90 between arms.|
1763745|NCT00107172|3237849|Superiority or Other (legacy)|||||||0.37|||||||Fisher Exact|||Compare the grade 3+ adverse events incidence reported from day 0 to 30 between arms.|
1763746|NCT00107172|3237854|Superiority or Other (legacy)||Cox Proportional Hazard|1.07||||0.75|2-Sided|95.0|0.71|1.61|||Log Rank||||
1763747|NCT00107172|3237855|Superiority or Other (legacy)||Cox Proportional Hazard|1.01||||0.98|2-Sided|95.0|0.51|1.98|||Log Rank|Competing risk P-value = 0.91.||The competing risk analysis accounting for death/regional and distant recurrence as competing events was performed.|
1763748|NCT00107120|3237856|Superiority or Other||Least Square Means Difference|2.169|Standard Error of the Mean|1.324||0.103||95.0|-0.439|4.777||Two-sided at 5% level of significance|ANCOVA||Differences are Escitalopram-Placebo|ANCOVA on the Change from Baseline to Week 8 in CGAS score. The model included treatment and center as factors and baseline score as covariate. Missing values were imputed using the LOCF approach.|
1763749|NCT00107120|3237857|Superiority or Other||Least Square Means Difference|-0.344|Standard Error of the Mean|0.1128||0.008||95.0|-0.595|0.092||Two-sided at 5% level of significance|ANCOVA|The model included treatment and center as factors and baseline CGI-Severity score as covariate.|Differences are Escitalopram-Placebo|Missing values were imputed using the LOCF approach.|
1763750|NCT00107120|3237858|Superiority or Other||Least Square Means Difference|-3.4|Standard Error of the Mean|1.458||0.022||95.0|-6.2|-0.5||Two-sided at 5% level of significance p < 0.05 considered significant|ANCOVA|The model included study center and treatment as factors and baseline core as covariate|Differences are Escitalopram-Placebo|The null hypothesis is that there is no difference in the Change from Baseline to Week 8 in CDRS-R total score between treatment groups. The power calculation was based on the change from baseline to Week 8 in CDRS-R total score (LOCF approach). Assuming an effect size (treatment group difference relative to standard deviation) of 0.325, a sample size of approximately 150 patients per treatment group was used to provide at least 80% power at a significance level of 0.05 using a two-sided test.|
1763751|NCT00107042|3237860|Superiority or Other||Responding Rate %|93.62|||||2-Sided|95.0|82.46|98.66|||||||
1763752|NCT00107042|3237860|Superiority or Other||Responding Rate %|85.37|||||2-Sided|95.0|70.83|94.43|||||||
1763753|NCT00107042|3237860|Superiority or Other|||||||0.2938|||||||Fisher Exact||||
1763754|NCT00107042|3237861|Superiority or Other||Responding Rate %|98.11|||||2-Sided|95.0|89.93|99.95|||||For overall response, if a subject is reactive at either 1-month or 12-month, then the overall response is considered “Positive”. If a subject is non-reactive at both 1-month and 12-month, then the overall response for this subject is “Negative”.||
1763755|NCT00107042|3237862|Superiority or Other||Responding Rate|91.49||||||95.0|79.62|97.63|||||||
1763756|NCT00107042|3237863|Superiority or Other||Responding rate|98.08|||||2-Sided|95.0|89.74|99.95|||||||
1763757|NCT00107042|3237864|Superiority or Other||Responding Rate|88.0|||||2-Sided|95.0|75.69|95.47|||||Response rate=Total number subjects responded/Total number subjects in arm||
1763758|NCT00107042|3237864|Superiority or Other||Responding Rate|81.08|||||2-Sided|95.0|68.84|92.04|||||Response rate=Total number subjects responded/Total number subjects in arm||
1763759|NCT00107042|3237864|Superiority or Other|||||||0.3827|||||||Fisher Exact||||
1763760|NCT00107042|3237865|Superiority or Other||Odds Ratio (OR)|0.36||||0.3846|2-Sided|95.0|0.04|3.61|||Univariate regression, logistic||"The reference group is the Ever used drugs not prescribed: NO group."||
1763761|NCT00107042|3237866|Superiority or Other||Odds Ratio (OR)|0.24||||0.0501|2-Sided|95.0|0.06|1.0|||Univariate regression, logistic||"The reference group is the Ever smoked marijuana: NO group."||
1763762|NCT00107042|3237867|Superiority or Other||Odds Ratio (OR)|0.48||||0.301|2-Sided|95.0|0.12|1.92|||Univariate regression, logistic||"The reference group is the Ever drank alcohol: NO group."||
1763763|NCT00107042|3237868|Superiority or Other||Odds Ratio (OR)|1.17||||0.8904|2-Sided|95.0|0.13|10.46|||Univariate Regression, Logistic||"The reference group is the 0 Partners group."||
1763764|NCT00107042|3237868|Superiority or Other||Odds Ratio (OR)|0.5||||0.5503|2-Sided|95.0|0.05|4.86|||Univariate regression, logistic||"The reference group is the 0 Partners group"||
1763768|NCT00107042|3237870|Superiority or Other||Odds Ratio (OR)|0.08||||0.0042|2-Sided|95.0|0.01|0.48|||Univariate regression, logistic||"The reference group is the 0 partners group"||
1763769|NCT00107042|3237871|Superiority or Other||Odds Ratio (OR)|0.12||||0.019|2-Sided|95.0|0.02|0.7|||Univariate regression, logistic||"The reference group is the Never (had sex) group."||
1763770|NCT00107042|3237871|Superiority or Other||Odds Ratio (OR)|1.17||||0.8945|2-Sided|95.0|0.12|11.83|||Univariate regression, logistic||"The reference group is the Never (had sex)group."||
1763771|NCT00107042|3237872|Superiority or Other||Odds Ratio (OR)|0.12||||0.0222|2-Sided|95.0|0.02|0.74||Since sexual identity was a factor with a p-value of < 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.|Multivariate regression, logistic||"The reference group is the Straight (heterosexual) group."||
1763772|NCT00107042|3237872|Superiority or Other||Odds Ratio (OR)|0.14||||0.0161|2-Sided|95.0|0.03|0.69|||Univariate regression, logistic||"The reference group is the Straight (heterosexual) group."||
1763773|NCT00107042|3237873|Superiority or Other||Odds Ratio (OR)|0.42||||0.2542|2-Sided|95.0|0.1|1.86|||Univariate regression, logistic||"The reference group is the Ever smoked cigarettes: NO group."||
1763774|NCT00107042|3237874|Superiority or Other||Odds Ratio (OR)|0.4||||0.1943|2-Sided|95.0|0.1|1.6|||Univariate regression, logistic||"The reference group is the Normal and Underweight (<25.0) group."||
1763775|NCT00107042|3237875|Superiority or Other||Odds Ratio (OR)|1.5||||0.6181|2-Sided|95.0|0.3|7.39|||Univariate regression, logistic||"The reference group is the Stage 5 group."||
1763776|NCT00107042|3237876|Superiority or Other||Odds Ratio (OR)|0.89||||0.939|2-Sided|95.0|0.05|15.44|||Univariate regression, logistic||The reference group is the 'Stage 5' group.||
1763777|NCT00107042|3237877|Superiority or Other||Odds Ratio (OR)|4.12||||0.2685|2-Sided|95.0|0.34|50.76|||Univariate regression, logistic||The reference group is the 'White' group.||
1763778|NCT00107042|3237877|Superiority or Other||Odds Ratio (OR)|0.4||||0.4241|2-Sided|95.0|0.04|3.84|||Univariate regression, logistic||The reference group is the 'White' group.||
1763779|NCT00107042|3237878|Superiority or Other||Odds Ratio (OR)|7.38||||0.0118|2-Sided|95.0|1.56|34.95||Since Hispanic (no, yes) was a factor with a p-value of < 0.15 in the unadjusted univariate regression analysis, it was entered into the initial full multivariate model.|Multivariate regression, logistic||"The reference group is the Hispanic: NO group."||
1763780|NCT00107042|3237878|Superiority or Other||Odds Ratio (OR)|6.86||||0.0102|2-Sided|95.0|1.58|29.78|||Univariate regression, logistic||The reference group is the 'Hispanic: NO' group.||
1763781|NCT00107042|3237879|Superiority or Other||Odds Ratio (OR)|0.45||||0.339|2-Sided|95.0|0.09|2.3|||Univariate regression, logistic||The reference group is the 'Female' group.||
1763782|NCT00107042|3237880|Superiority or Other||Odds Ratio (OR)|1.84||||0.4646|2-Sided|95.0|0.36|9.36|||Univariate regression, logistic||The reference group is the '15-17 year' age group||
1763783|NCT00107042|3237881|Superiority or Other||Odds Ratio (OR)|1.52||||0.5524|2-Sided|95.0|0.38|6.01|||Univariate regression, logistic||The reference group is the 'Other Sites' group.||
1763784|NCT00107042|3237882|Superiority or Other||Odds Ratio (OR)|2.54||||0.2068|2-Sided|95.0|0.6|10.76|||Univariate regression, logistic||The reference group is the 'Recombivax' group.||
1763785|NCT00107042|3237883|Superiority or Other||Regression coefficient|-0.3474|Standard Error of the Mean|0.3924||0.3788||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever used drugs not prescribed(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.|
1763786|NCT00107042|3237883|Superiority or Other||Regression coefficient|-0.3548|Standard Error of the Mean|0.2076||0.0917||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever smoked marijuana(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.|
1763787|NCT00107042|3237883|Superiority or Other||Regression coefficient|-0.0307|Standard Error of the Mean|0.1809||0.8657||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of whether a subject ever drank alcohol (No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.|
1763788|NCT00107042|3237883|Superiority or Other||Regression coefficient|0.1083|Standard Error of the Mean|0.3488||0.7572||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. >= 6 partners is presented.|
1763789|NCT00107042|3237883|Superiority or Other||Regression coefficient|-0.1788|Standard Error of the Mean|0.2463||0.4701||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.|
1763790|NCT00107042|3237883|Superiority or Other||Regression coefficient|-1.6163|Standard Error of the Mean|0.2839||0||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. >= 6 partners is presented.|
1763791|NCT00107042|3237883|Superiority or Other||Regression coefficient|0.2921|Standard Error of the Mean|0.2086||0.1659||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.|
1763792|NCT00107042|3237883|Superiority or Other||Regression coefficient|-0.7752|Standard Error of the Mean|0.242||0.002||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Total Number of Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. >= 6 partners is presented.|
1763793|NCT00107042|3237883|Superiority or Other||Regression coefficient|0.1532|Standard Error of the Mean|0.1896||0.4219||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of total number of lifetime sex partners (0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.|
1763794|NCT00107042|3237883|Superiority or Other||Regression coefficient|0.0344|Standard Error of the Mean|0.2065||0.8682||95.0|||||Regression, Linear|||"This is a regression analysis for testing the effect of age at which subject had first unforced sex (Never vs. <= 14 year olds vs. 15 - 17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. 15-17 year olds is presented."|
1763795|NCT00107042|3237883|Superiority or Other||Regression coefficient|-0.3883|Standard Error of the Mean|0.2779||0.167||95.0|||||Regression, Linear|||"This is a regression analysis for testing the effect of age at which the subject first had unforced sex (Never vs. <= 14 year olds vs. 15-17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between never vs. <= 14 year olds is presented."|
1763796|NCT00107042|3237883|Superiority or Other||Regression coefficient|-0.5339|Standard Error of the Mean|0.2803||0.0607||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of sexual identity(Straight (heterosexual) vs. Gay (homosexual), Bi (bisexual), and Not Sure or Undecided) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.|
1763797|NCT00107042|3237883|Superiority or Other||Regression coefficient|-0.0578|Standard Error of the Mean|0.2163||0.7899||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of smokng cigarettes(Never Smoked vs. Has Smoked) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.|
1763798|NCT00107042|3237883|Superiority or Other||Regression coefficient|-0.0292|Standard Error of the Mean|0.0113||0.0117||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of BMI at Baseline(continuous variable) on vaccine response as measured in log10 titers.|
1763799|NCT00107042|3237883|Superiority or Other||Regression coeffcient|-0.316|Standard Error of the Mean|0.1826||0.0877||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of BMI at Baseline(Normal and Underweight (<25.0) vs. Overweight and Obsese (>= 25.0)) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.|
1763800|NCT00107042|3237883|Superiority or Other||Regression coefficient|-0.2929|Standard Error of the Mean|0.2508||0.2492||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Tanner Stage for Males(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.|
1763801|NCT00107042|3237883|Superiority or Other||Regression coefficient|-0.0663|Standard Error of the Mean|0.2314||0.7766||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Tanner Stage for Females(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.|
1763802|NCT00107042|3237883|Superiority or Other||Regression coefficient|0.0083|Standard Error of the Mean|0.3497||0.9812||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Black/African American is presented.|
1763803|NCT00107042|3237883|Superiority or Other||Regression coefficient|0.2994|Standard Error of the Mean|0.3292||0.3661||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Other/Mixed Race is presented.|
1763804|NCT00107042|3237883|Superiority or Other||Regression coefficient|0.2189|Standard Error of the Mean|0.1905||0.2543||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of Hispanic ethnicity (Not Hispanic vs. Hispanic) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.|
1763805|NCT00107042|3237883|Superiority or Other||Regresssion coeffcient|-0.4726|Standard Error of the Mean|0.1734||0.008||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of gender(Females vs. Males) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.|
1763806|NCT00107042|3237883|Superiority or Other||Regression coeffcient|0.2053|Standard Error of the Mean|0.1885||0.2796||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of age(15 - 17 year old particpants vs. 12 - 14 year old participants) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.|
1763807|NCT00107042|3237883|Superiority or Other||Regression coefficent|-0.0025|Standard Error of the Mean|0.1792||0.989||95.0|||||Regression, Linear|||This is a regression analysis for testing the effect of site effect(Other sites vs. Baltimore) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.|
1763808|NCT00107042|3237883|Superiority or Other||Regression coefficient|0.2455|Standard Error of the Mean|0.1757||0.1667|||||||Regression, Linear|||This is a regression analysis for testing the effect of treatment arm (Recombivax vs. Twinrix) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.|
1763809|NCT00107042|3237886|Superiority or Other||Response rate|2.58|||||2-Sided|95.0|2.4|2.76||||||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Twinrix arm is presented here."|
1763810|NCT00107042|3237886|Superiority or Other||Mean response|2.29|||||2-Sided|95.0|2.05|2.53||||||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here."|
1763811|NCT00107042|3237886|Superiority or Other|||||||0.0608|||||||Wilcoxon (Mann-Whitney)|||Analysis included an assessment of quantitative titer values in each of the two arms using confidence intervals and examining the frequency distributions of the titers in each arm. Transformations were considered (log10) for the titers based on the distributional properties observed in the sample, with the goal of attaining approximate normality of the transformed data.|
1763812|NCT00107042|3237887|Superiority or Other||Response Rate|94.55|||||2-Sided|95.0|84.88|98.86||||||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the 'Twinrix arm is presented here."|
1763813|NCT00107042|3237887|Superiority or Other||Response Rate|87.23|||||2-Sided|95.0|74.26|95.17||||||"Two-sided confidence intervals (CI) were calculated for both the Recombivax and Twinrix arms. The CI for the Recombivax arm is presented here."|
1763814|NCT00107042|3237887|Superiority or Other|||||||0.2954|||||||Fisher Exact|||The study wasn't powered to compare the 2 arms but to detect a large difference. A quantitative antibody (a'body) response was measured, but for sample size and power considerations, the outcome was considered to be binary. The primary analysis involved straightforward computation of point estimates and exact confidence intervals of immunogenicity in each arm. The data for primary analysis used the Intent-to-Treat for subjects who were vaccinated at least once. Missing titers were not imputed.|
1763815|NCT00106964|3237888|Superiority or Other||Odds Ratio (OR)|1.99||||0.0244|2-Sided|95.0|1.09|3.63|||Regression, Logistic||Adjusted odds ratio||
1763816|NCT00106964|3237888|Superiority or Other||Odds Ratio (OR)|0.29||||0.0853|2-Sided|95.0|0.07|1.19|||Regression, Logistic||Adjusted odds ratio (OR) Odds ratio depends on CD4 count resulting from interaction. For example, OR=0.29 for CD4 count = 0; OR= 2.91 for CD4 count = 460 (median CD4 count for the evaluable study population).||
1763817|NCT00106964|3237889|Superiority or Other||Hazard Ratio (HR)|1.05||||0.8698||95.0|||||Regression, Cox||||
1763818|NCT00106964|3237889|Superiority or Other||Hazard Ratio (HR)|0.84||||0.5822||95.0|||||Regression, Cox||||
1763819|NCT00106964|3237893|Superiority or Other|||||||0.0157|||||||Chi-squared||||
1763820|NCT00106964|3237893|Superiority or Other|||||||0.044|||||||Chi-squared||||
1763821|NCT00106704|3237927|Superiority or Other||Mean Difference (Net)|-20.1|Standard Error of the Mean|4.2|<|0.001|2-Sided|95.0|-28.4|-11.8|||ANCOVA|Model terms: treatment, stratum (on metformin or not at Visit 3), baseline A1C|||
1763822|NCT00106704|3237928|Superiority or Other||Mean Difference (Net)|-0.74|Standard Error of the Mean|0.08|<|0.001|2-Sided|95.0|-90.0|-0.57|||ANCOVA|Model terms: treatment, stratum (on metformin or not), baseline A1C|||
1763823|NCT00106535|3238020|Superiority or Other||||||<|0.0001|||||||Van Elteren's test|Stratified by region.|||
1763824|NCT00106535|3238020|Superiority or Other||||||<|0.0001|||||||Van Elteren's test|Stratified by region.|||
1763825|NCT00106535|3238021|Superiority or Other||||||<|0.0001|||||||Van Elteren's test||||
1763826|NCT00106535|3238021|Superiority or Other||||||<|0.0023|||||||Van Elteren's test|Stratified by region.|||
1763827|NCT00106535|3238037|Superiority or Other||Mean Difference (Final Values)|7092.76|||<|0.0001|2-Sided|95.0|5066.16|9119.36||Adjusted for region.|ANOVA||||
1763828|NCT00106535|3238037|Superiority or Other||Mean Difference (Final Values)|5212.28|||<|0.0001|2-Sided|95.0|3139.4|7285.16|||ANOVA|Adjusted for region.|||
1763829|NCT00106535|3238062|Superiority or Other||Mean Difference (Final Values)|-181.4|||<|0.0001|2-Sided|95.0|-238.6|-124.21|||ANOVA|Adjusted for region.|||
1763830|NCT00106535|3238062|Superiority or Other||Mean Difference (Final Values)|-148.1|||<|0.0001|2-Sided|95.0|-205.22|-90.98|||ANOVA|Adjusted for region.|||
1763831|NCT00106535|3238064|Superiority or Other||Mean Difference (Final Values)|-85.95|||<|0.0001|2-Sided|95.0|-112.69|-59.22|||ANOVA|Adjusted for region and original treatment group.|||
1763832|NCT00106535|3238064|Superiority or Other||Mean Difference (Final Values)|-70.26|||<|0.0001|2-Sided|95.0|-96.96|-43.56|||ANOVA|Adjusted for region and original treatment group.|||
1763833|NCT00106535|3238065|Superiority or Other||||||<|0.0001|||||||Van Elteren's test|Stratified by region.|||
1763834|NCT00106535|3238065|Superiority or Other||||||<|0.0001|||||||Van Elteren's test|Stratified by region.|||
1763835|NCT00106535|3238074|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1763836|NCT00106535|3238074|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1763837|NCT00106535|3238075|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1763838|NCT00106535|3238075|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1763839|NCT00106535|3238076|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1763840|NCT00106535|3238076|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1763841|NCT00106392|3238084|Superiority or Other|||||||0.879|||||||Wilcoxon (Mann-Whitney)||||
1763842|NCT00106392|3238085|Superiority or Other|||||||0.575|||||||Wilcoxon (Mann-Whitney)||||
1763843|NCT00106392|3238086|Superiority or Other|||||||0.099|||||||Fisher Exact||||
1763844|NCT00106392|3238087|Superiority or Other|||||||0.79|||||||Wilcoxon (Mann-Whitney)||||
1763845|NCT00106392|3238088|Superiority or Other|||||||0.453|||||||Fisher Exact||||
1763846|NCT00106392|3238089|Superiority or Other|||||||0.111||||||P-Values were not adjusted.|Wilcoxon (Mann-Whitney)|||A group sequential design using the O'Brien and Fleming stopping rule will require 58 evaluable patients per group to detect a 5-point difference in the Erectile Function domain of the IIEF with a power of 80% and an overall significance level of 5%.|
1763847|NCT00106249|3238129|Superiority or Other||||||<|0.05|||||||t-test, 2 sided||||
1763848|NCT00106249|3238130|Superiority or Other||||||<|0.05|||||||ANOVA||||
1763849|NCT00106184|3238131|Superiority or Other||||||>|0.9|||||||Log Rank||||
1763850|NCT00106184|3238132|Superiority or Other||||||>|0.9|||||||Chi-squared|Difference in baseline muscle enzymes therefore tested the difference in the proportions adjusting for the baseline values.|||
1763851|NCT00106184|3238133|Superiority or Other||||||=|0|||||||Log Rank|No confidence intervals as no parameters were estimated.||Proportional hazards model|
1763852|NCT00106080|3238151|Superiority or Other (legacy)||Difference between groups after adjust|5.7||||0.03||||||No multiple comparisons, a priori threshold < 0.05|GEE regression|Generalized estimating equations (GEE) regression, clustering for provider.||Power calculation: With 60 providers in each group, maintaining the probability of a type I error of 0.05, power of 0.90, provider level mean QOC score of 54.5 and provider level standard deviation in QOC score of 12.0, the minimal detectable difference in QOC score would be 7.5.|
1764489|NCT00095498|3239351|Superiority or Other||||||<|0.001|||||||van Elteren Stratified Rank Test||||
1763853|NCT00106028|3238152|Superiority or Other||Mean Difference (Net)|0.029||||0.6218|2-Sided|95.0|-0.084|0.142|||ANOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763854|NCT00106028|3238153|Superiority or Other||Mean Difference (Net)|0.107||||0.34||95.0|-0.114|0.328|||ANOVA|LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763855|NCT00106028|3238154|Superiority or Other||Mean Difference (Net)|0.009||||0.9596|2-Sided|95.0|-0.336|0.354|||ANOVA|LS means and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763856|NCT00106028|3238155|Superiority or Other||Mean Difference (Net)|0.007||||0.9622||95.0|-0.304|0.319|||ANOVA|LS mean and p-value are from ANOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763857|NCT00106028|3238156|Superiority or Other||Mean Difference (Net)|0.127||||0.2917||95.0|-0.111|0.365|||ANOVA|LS means and p-value are from ANOVA model with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763858|NCT00106028|3238157|Superiority or Other||Mean Difference (Net)|-0.352||||0.1592||95.0|-0.845|0.14|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763859|NCT00106028|3238158|Superiority or Other||Mean Difference (Net)|-5.039||||0.3998|2-Sided|95.0|-16.849|6.772|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763860|NCT00106028|3238159|Superiority or Other||Mean Difference (Net)|9.04||||0.3075|2-Sided|95.0|-8.433|26.512|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763861|NCT00106028|3238160|Superiority or Other||Mean Difference (Net)|-26.629|||<|0.0001||95.0|-38.089|-15.169|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763862|NCT00106028|3238161|Superiority or Other||Mean Difference (Net)|-4.686||||0.3826|2-Sided|95.0|-15.276|5.903|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763863|NCT00106028|3238162|Superiority or Other||Mean Difference (Net)|0.067||||0.9907|2-Sided|95.0|-11.401|11.536|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763864|NCT00106028|3238163|Superiority or Other||Mean Difference (Net)|-11.678||||0.0318||95.0|-22.325|-1.031|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763865|NCT00106028|3238164|Superiority or Other||Hazard Ratio (HR)|0.682||||0.682|2-Sided|95.0|0.304|1.532||Other Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763866|NCT00106028|3238164|Superiority or Other||Hazard Ratio (HR)|0.543||||0.0799|2-Sided|95.0|0.274|1.076||Long Bone Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763867|NCT00106028|3238164|Superiority or Other||Hazard Ratio (HR)|0.584||||0.0416|2-Sided|95.0|0.348|0.98||Non-Vertebral Fracture|Wald Test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763868|NCT00106028|3238164|Superiority or Other||Hazard Ratio (HR)|0.584||||0.0416||95.0|0.348|0.98||All Fractures|Wald test|Hazard Ratio and 95% CI based on Anderson-Gill mean intensity model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763869|NCT00106028|3238165|Superiority or Other||Hazard Ratio (HR)|0.608||||0.2141|2-Sided|95.0|0.262|1.41||Other Non-Vertebral Fracture|Cox Proportional Hazard|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763870|NCT00106028|3238165|Superiority or Other||Hazard Ratio (HR)|0.487||||0.0501|2-Sided|95.0|0.25|0.95||Long Bone Non-Vertebral Fracture|Cox Proportional Hazards|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763871|NCT00106028|3238165|Superiority or Other||Hazard Ratio (HR)|0.534||||0.0253|2-Sided|95.0|0.31|0.922||All Non-Vertebral Fractures|Cox Proportional Hazard|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763872|NCT00106028|3238165|Superiority or Other||Hazard Ratio (HR)|0.534||||0.0253||95.0|0.31|0.922||All Fractures|Cox proportional hazards|Hazard Ratio and 95% CI based on Cox proportional hazards model stratified by age group with treatment and pooled-country as covariates.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763873|NCT00106028|3238168|Superiority or Other|||||||0.3408|||||||Savage Exact Test|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763874|NCT00106028|3238169|Superiority or Other|||||||0.3658|||||||Savage Exact Test|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763875|NCT00106028|3238170|Superiority or Other|||||||0.4121|||||||Fisher Exact|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763876|NCT00106028|3238171|Superiority or Other|||||||0.068|||||||Fisher Exact|||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763877|NCT00106028|3238172|Superiority or Other||Mean Difference (Net)|1.193||||0.684|2-Sided|95.0|-4.604|6.991|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763878|NCT00106028|3238173|Superiority or Other||Mean Difference (Net)|1.065||||0.5925|2-Sided|95.0|-2.868|4.998|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763879|NCT00106028|3238174|Superiority or Other||Mean Difference (Net)|3.534||||0.027||95.0|0.41|6.658|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763880|NCT00106028|3238175|Superiority or Other||Mean Difference (Net)|-1.66||||0.4978|2-Sided|95.0|-6.499|3.179|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763881|NCT00106028|3238176|Superiority or Other||Mean Difference (Net)|0.884||||0.6404|2-Sided|95.0|-2.855|4.623|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763882|NCT00106028|3238177|Superiority or Other||Mean Difference (Net)|1.014||||0.4154||95.0|-1.442|3.47|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763883|NCT00106028|3238178|Superiority or Other||Mean Difference (Net)|-8.64||||0.5971|2-Sided|95.0|-40.952|23.672|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763884|NCT00106028|3238179|Superiority or Other||Mean Difference (Net)|-0.492||||0.9786|2-Sided|95.0|-36.807|35.824|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763885|NCT00106028|3238180|Superiority or Other||Mean Difference (Net)|37.594||||0.0172||95.0|6.801|68.386|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763918|NCT00105989|3238219|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763886|NCT00106028|3238181|Superiority or Other||Mean Difference (Net)|6.315||||0.4575|2-Sided|95.0|-10.477|23.107|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763887|NCT00106028|3238182|Superiority or Other||Mean Difference (Net)|8.567|||<|0.0001||95.0|5.59|11.545|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763888|NCT00106028|3238183|Superiority or Other||Mean Difference (Net)|14.029||||0.0793|2-Sided|95.0|-1.667|29.726|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763889|NCT00106028|3238184|Superiority or Other||Mean Difference (Net)|31.675|||<|0.0001||95.0|21.051|42.3|||ANCOVA|LS means and p-value are from ANCOVA model adjusted for baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763890|NCT00106028|3238185|Superiority or Other||Mean Difference (Net)|0.315||||0.9372|2-Sided|95.0|-7.598|8.229|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763891|NCT00106028|3238186|Superiority or Other||Mean Difference (Net)|1.473||||0.6106|2-Sided|95.0|-4.245|7.192|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763892|NCT00106028|3238187|Superiority or Other||Mean Difference (Net)|5.494||||0.003||95.0|1.912|9.077|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763893|NCT00106028|3238188|Superiority or Other||Mean Difference (Net)|0.28||||0.9646|2-Sided|95.0|-12.196|12.755|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763894|NCT00106028|3238189|Superiority or Other||Mean Difference (Net)|6.04||||1789|2-Sided|95.0|-2.807|14.887|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763895|NCT00106028|3238190|Superiority or Other||Mean Difference (Net)|10.333|||<|0.0001||95.0|5.258|15.408|||ANCOVA|LS Means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763919|NCT00105989|3238220|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763920|NCT00105989|3238221|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764490|NCT00095498|3239351|Superiority or Other||||||<|0.001|||||||van Elteren Stratified Rank Test||||
1763896|NCT00106028|3238191|Superiority or Other||Mean Difference (Net)|-0.465||||0.7391|2-Sided|95.0|-3.224|2.294|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763897|NCT00106028|3238192|Superiority or Other||Mean Difference (Net)|0.498||||0.6466|2-Sided|95.0|-1.648|2.644|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763898|NCT00106028|3238193|Superiority or Other||Mean Difference (Net)|1.554||||0.0808||95.0|-0.193|3.301|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and with fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763899|NCT00106028|3238194|Superiority or Other||Mean Difference (Net)|1.537||||0.6103|2-Sided|95.0|-4.424|7.497|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763900|NCT00106028|3238195|Superiority or Other||Mean Difference (Net)|4.438||||0.0625|2-Sided|95.0|-0.235|9.111|||ANCOVA|LS means and p-value are from ANCOVA model adjusted by baseline and fixed effects for age group, treatment and pooled center for post-baseline.||A total of 123 patients were to be randomized in 2:1 ratio. The sample size allowed detection of a difference of at least 5% in lumbar spine BMD percent change from baseline to 12 months with 90% power. Calculation based on assumption that common within-group SD would be approximately 7% and dropout rate within Year 1 would be 20%. A difference of 5% in lumbar spin BMD percent change from baseline was considered clinically meaningful.|
1763901|NCT00105989|3238203|Superiority or Other|||||||0.03||||||P-value for non-fasting glucose change from baseline to endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.|||
1763902|NCT00105989|3238203|Superiority or Other|||||||0.744||||||P-value for fasting glucose change from baseline to endpoint|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.|||
1763903|NCT00105989|3238204|Superiority or Other|||||||0.011||||||P-value for Change to Endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.|||
1763904|NCT00105989|3238205|Superiority or Other|||||||0.035||||||P-value for Change to Endpoint.|ANOVA|Type II Sums of Squares from an analysis of variance (ANOVA) on the Ranks: Model = Pooled Investigator and Therapy.|||
1763905|NCT00105989|3238206|Superiority or Other|||||||0.046|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763906|NCT00105989|3238207|Superiority or Other|||||||0.008|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763907|NCT00105989|3238208|Superiority or Other|||||||0.028|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763908|NCT00105989|3238209|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763909|NCT00105989|3238210|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763910|NCT00105989|3238211|Superiority or Other|||||||0.032|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763911|NCT00105989|3238212|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763912|NCT00105989|3238213|Superiority or Other|||||||0.021||||||The mean change to endpoint of -0.00 indicates that on average, endpoint score decreased from baseline score by less than 0.005 units.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763913|NCT00105989|3238214|Superiority or Other|||||||0.015|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763914|NCT00105989|3238215|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763915|NCT00105989|3238216|Superiority or Other|||||||0.003|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763916|NCT00105989|3238217|Superiority or Other|||||||0.01|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763917|NCT00105989|3238218|Superiority or Other|||||||0.004|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763985|NCT00105989|3238242|Superiority or Other|||||||0.037|||||||t-test, 2 sided||||
1763921|NCT00105989|3238222|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763922|NCT00105989|3238223|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763923|NCT00105989|3238224|Superiority or Other|||||||0.031|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763924|NCT00105989|3238225|Superiority or Other|||||||0.005|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763925|NCT00105989|3238226|Superiority or Other|||||||0.019||||||The mean change to endpoint of -0.00 indicates that on average, endpoint score decreased from baseline score by less than 0.005 units.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763926|NCT00105989|3238227|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763927|NCT00105989|3238228|Superiority or Other|||||||0.021|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763928|NCT00105989|3238229|Superiority or Other|||||||0.035|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763929|NCT00105989|3238230|Superiority or Other|||||||0.007|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763930|NCT00105989|3238231|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763931|NCT00105989|3238232|Superiority or Other|||||||0.816||||||P-value for Change from Baseline: diastolic blood pressure.|t-test, 2 sided||||
1763932|NCT00105989|3238232|Superiority or Other|||||||0.134||||||P-value for Change from Baseline: systolic blood pressure.|t-test, 2 sided||||
1763933|NCT00105989|3238233|Superiority or Other|||||||0.21||||||P-value for diastolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763934|NCT00105989|3238233|Superiority or Other|||||||0.224||||||P-value for systolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763935|NCT00105989|3238233|Superiority or Other|||||||0.064||||||P-value for diastolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763936|NCT00105989|3238233|Superiority or Other|||||||0.659||||||P-value for systolic blood pressure change to endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763937|NCT00105989|3238234|Superiority or Other|||||||0.891|||||||t-test, 2 sided||||
1763938|NCT00105989|3238235|Superiority or Other||||||<|0.001||||||P-value for Pulse Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763939|NCT00105989|3238235|Superiority or Other||||||<|0.001||||||P-value for Pulse Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763940|NCT00105989|3238236|Superiority or Other|||||||0.314|||||||t-test, 2 sided||||
1763941|NCT00105989|3238237|Superiority or Other||||||<|0.001||||||P-value for Weight Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763942|NCT00105989|3238237|Superiority or Other||||||<|0.001||||||P-value for Weight Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763943|NCT00105989|3238238|Superiority or Other|||||||0.071||||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 5-Satisfaction.|t-test, 2 sided||||
1763944|NCT00105989|3238238|Superiority or Other|||||||0.609||||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 4-Orgasm.|t-test, 2 sided||||
1763945|NCT00105989|3238238|Superiority or Other|||||||0.844||||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 3-Vaginal Lubrication/Penile Erection.|t-test, 2 sided||||
1763946|NCT00105989|3238238|Superiority or Other|||||||0.163||||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 2-Arousal.|t-test, 2 sided||||
1763947|NCT00105989|3238238|Superiority or Other|||||||0.18||||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 1-Sex Drive.|t-test, 2 sided||||
1763948|NCT00105989|3238238|Superiority or Other|||||||0.132||||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 and 2.|t-test, 2 sided||||
1763949|NCT00105989|3238238|Superiority or Other|||||||0.979||||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 to 5.|t-test, 2 sided||||
1763950|NCT00105989|3238239|Superiority or Other|||||||0.566||||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 5-Satisfaction.|t-test, 2 sided||||
1763951|NCT00105989|3238239|Superiority or Other|||||||0.093||||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 4-Orgasm.|t-test, 2 sided||||
1763952|NCT00105989|3238239|Superiority or Other|||||||0.268||||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 3-Vaginal Lubrication/Penile Erection.|t-test, 2 sided||||
1763953|NCT00105989|3238239|Superiority or Other|||||||0.384||||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 2-Arousal.|t-test, 2 sided||||
1763954|NCT00105989|3238239|Superiority or Other|||||||0.443||||||P-value for pairwise comparison Least Squares Mean change from baseline for Item 1-Sex Drive.|t-test, 2 sided||||
1763955|NCT00105989|3238239|Superiority or Other|||||||0.405||||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 and 2.|t-test, 2 sided||||
1763956|NCT00105989|3238239|Superiority or Other|||||||0.773||||||P-value for pairwise comparison Least Squares Mean change from baseline for the Sum of Items 1 to 5.|t-test, 2 sided||||
1763957|NCT00105989|3238240|Superiority or Other|||||||0.308||||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763958|NCT00105989|3238240|Superiority or Other||||||<|0.001||||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763959|NCT00105989|3238240|Superiority or Other||||||<|0.186||||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763960|NCT00105989|3238240|Superiority or Other||||||<|0.001||||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763961|NCT00105989|3238240|Superiority or Other||||||<|0.001||||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763962|NCT00105989|3238240|Superiority or Other||||||<|0.001||||||P-value for Sum Items 1&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763963|NCT00105989|3238240|Superiority or Other||||||<|0.002||||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763964|NCT00105989|3238240|Superiority or Other||||||<|0.022||||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763965|NCT00105989|3238240|Superiority or Other||||||<|0.05||||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763966|NCT00105989|3238240|Superiority or Other||||||<|0.005||||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763967|NCT00105989|3238240|Superiority or Other||||||<|0.001||||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763968|NCT00105989|3238240|Superiority or Other||||||<|0.001||||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763969|NCT00105989|3238240|Superiority or Other||||||<|0.001||||||P-value for Sum Items 1&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763970|NCT00105989|3238240|Superiority or Other||||||<|0.001||||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763971|NCT00105989|3238241|Superiority or Other|||||||0.152||||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763972|NCT00105989|3238241|Superiority or Other|||||||0.136||||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763973|NCT00105989|3238241|Superiority or Other|||||||0.668||||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763974|NCT00105989|3238241|Superiority or Other|||||||0.023||||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763975|NCT00105989|3238241|Superiority or Other|||||||0.047||||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763976|NCT00105989|3238241|Superiority or Other|||||||0.021||||||P-value for Sum Items 1&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763977|NCT00105989|3238241|Superiority or Other|||||||0.1||||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763978|NCT00105989|3238241|Superiority or Other|||||||0.67||||||P-value for Item 5-Satisfaction Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763979|NCT00105989|3238241|Superiority or Other|||||||0.009||||||P-value for Item 4-Orgasm Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763980|NCT00105989|3238241|Superiority or Other|||||||0.877||||||P-value for Item 3-Vaginal Lubrication/Penile Erection Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763981|NCT00105989|3238241|Superiority or Other|||||||0.825||||||P-value for Item 2-Arousal Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763982|NCT00105989|3238241|Superiority or Other|||||||0.17||||||P-value for Item 1-Sex Drive Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763983|NCT00105989|3238241|Superiority or Other|||||||0.354||||||P-value for Sum Items 1&2 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763984|NCT00105989|3238241|Superiority or Other|||||||0.785||||||P-value for Sum Items 1 to 5 Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763986|NCT00105989|3238243|Superiority or Other|||||||0.174||||||P-value for Change in Number of Missed Paid Work Hours in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763987|NCT00105989|3238243|Superiority or Other|||||||0.105||||||P-value for Change in Number of Missed Paid Work Hours in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763988|NCT00105989|3238244|Superiority or Other|||||||0.826|||||||t-test, 2 sided||||
1763989|NCT00105989|3238245|Superiority or Other|||||||0.057||||||P-value for Change in Average Number of Hours Worked In a Week in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763990|NCT00105989|3238245|Superiority or Other|||||||0.506||||||P-value for Change in Average Number of Hours Worked In a Week in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763991|NCT00105989|3238246|Superiority or Other|||||||0.271||||||P-value for pairwise comparison of means for change from baseline to endpoint in Other (Specified by Patient) Provider visits.|t-test, 2 sided||||
1763992|NCT00105989|3238246|Superiority or Other|||||||0.511||||||P-value for pairwise comparison of means for change from baseline to endpoint in Other Specialist Physician visits.|t-test, 2 sided||||
1763993|NCT00105989|3238246|Superiority or Other|||||||0.746||||||P-value for pairwise comparison of means for change from baseline to endpoint in Psychologist/Therapist visits.|t-test, 2 sided||||
1763994|NCT00105989|3238246|Superiority or Other|||||||0.668||||||P-value for pairwise comparison of means for change from baseline to endpoint in Psychiatrist visits.|t-test, 2 sided||||
1763995|NCT00105989|3238246|Superiority or Other|||||||0.462||||||P-value for pairwise comparison of means for change from baseline to endpoint in Primary Health Care Provider visits.|t-test, 2 sided||||
1763996|NCT00105989|3238247|Superiority or Other|||||||0.362||||||P-value for change in number of Other (Specified by Patient) visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763997|NCT00105989|3238247|Superiority or Other|||||||0.223||||||P-value for change in number of Other Specialist Physician visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763998|NCT00105989|3238247|Superiority or Other|||||||0.915||||||P-value for change in number of Psychologist/Therapist visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1763999|NCT00105989|3238247|Superiority or Other||||||<|0.001||||||P-value for change in number of Psychiatrist visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764000|NCT00105989|3238247|Superiority or Other||||||<|0.325||||||P-value for change in number of Primary Health Care Provider visits in Continuation Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764001|NCT00105989|3238247|Superiority or Other||||||<|0.423||||||P-value for change in number of Other (Specified by Patient) visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764002|NCT00105989|3238247|Superiority or Other||||||<|0.145||||||P-value for change in number of Other Specialist Physician visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764003|NCT00105989|3238247|Superiority or Other||||||<|0.236||||||P-value for change in number of Psychologist/Therapist visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764004|NCT00105989|3238247|Superiority or Other||||||<|0.001||||||P-value for change in number of Psychiatrist visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764005|NCT00105989|3238247|Superiority or Other||||||<|0.838||||||P-value for change in number of Primary Health Care Provider Visits in Acute Phase|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764006|NCT00105989|3238248|Superiority or Other|||||||0.218||||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Health Compared to a Year Ago.|t-test, 2 sided||||
1764007|NCT00105989|3238248|Superiority or Other|||||||0.615||||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Rate General Health.|t-test, 2 sided||||
1764008|NCT00105989|3238248|Superiority or Other|||||||0.24||||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Vitality.|t-test, 2 sided||||
1764009|NCT00105989|3238248|Superiority or Other|||||||0.142||||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Social Functioning.|t-test, 2 sided||||
1764010|NCT00105989|3238248|Superiority or Other|||||||0.001||||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Mental Health.|t-test, 2 sided||||
1764011|NCT00105989|3238248|Superiority or Other|||||||0.391||||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-General Health Perceptions.|t-test, 2 sided||||
1764012|NCT00105989|3238248|Superiority or Other|||||||0.003||||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Role Limitations Due to Emotional problems.|t-test, 2 sided||||
1764013|NCT00105989|3238248|Superiority or Other|||||||0.029||||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Role Limitations Due to Physical.|t-test, 2 sided||||
1764014|NCT00105989|3238248|Superiority or Other|||||||0.438||||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Bodily Pain.|t-test, 2 sided||||
1764015|NCT00105989|3238248|Superiority or Other|||||||0.731||||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Physical Functioning.|t-test, 2 sided||||
1764016|NCT00105989|3238248|Superiority or Other|||||||0.002||||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Mental Component Summary.|t-test, 2 sided||||
1764017|NCT00105989|3238248|Superiority or Other|||||||0.415||||||P-value is pairwise comparison of Least Squares Means for Change from Baseline-Physical Component Summary.|t-test, 2 sided||||
1764018|NCT00105989|3238249|Superiority or Other||||||<|0.001||||||P-value for Health Compared to a Year Ago Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764019|NCT00105989|3238249|Superiority or Other||||||<|0.815||||||P-value for Rate Current Health Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764020|NCT00105989|3238249|Superiority or Other||||||<|0.001||||||P-value for Vitality Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764021|NCT00105989|3238249|Superiority or Other||||||<|0.001||||||P-value for Social Function Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764022|NCT00105989|3238249|Superiority or Other||||||<|0.001||||||P-value for Mental Health Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764023|NCT00105989|3238249|Superiority or Other||||||<|0.002||||||P-value for General Health Perceptions Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764024|NCT00105989|3238249|Superiority or Other||||||<|0.001||||||P-value for Role Limitations Due to Emotional Problems Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764025|NCT00105989|3238249|Superiority or Other||||||<|0.029||||||P-value for Role Limitations Due to Physical Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764026|NCT00105989|3238249|Superiority or Other||||||<|0.55||||||P-value for Bodily Pain Change from Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764027|NCT00105989|3238249|Superiority or Other||||||<|0.118||||||P-value for Physical Functioning Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764028|NCT00105989|3238249|Superiority or Other||||||<|0.001||||||P-value for Mental Component Summary Change to Endpoint|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764029|NCT00105989|3238249|Superiority or Other||||||<|0.947||||||P-value for Physical Component Summary Change to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764030|NCT00105989|3238249|Superiority or Other||||||<|0.001||||||P-values for Change from Baseline to Endpoint in all SF-36 subscales in the Acute Phase were <0.001|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764031|NCT00105989|3238250|Superiority or Other|||||||0.021||||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Family Life/Home Responsibilities.|t-test, 2 sided||||
1764032|NCT00105989|3238250|Superiority or Other|||||||0.11||||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Social Life.|t-test, 2 sided||||
1764033|NCT00105989|3238250|Superiority or Other|||||||0.022||||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Work/School.|t-test, 2 sided||||
1764034|NCT00105989|3238250|Superiority or Other|||||||0.029||||||P-value for pairwise comparison of Least Squares Means for Change from Baseline to Endpoint in Global Score|t-test, 2 sided||||
1764035|NCT00105989|3238251|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline to Endpoint in all SDS items in the Continuation Phase were <0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764036|NCT00105989|3238251|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline to Endpoint in all SDS items in Acute Phase were <0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764037|NCT00105989|3238252|Superiority or Other|||||||0.979|||||||t-test, 2 sided||||
1764038|NCT00105989|3238253|Superiority or Other|||||||0.157||||||P-value for Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764039|NCT00105989|3238253|Superiority or Other||||||<|0.001||||||P-value for Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764040|NCT00105989|3238254|Superiority or Other|||||||0.717||||||P-value for pairwise comparison of Least Squares Means for Pain While Awake Change from Baseline to Endpoint.|t-test, 2 sided||||
1764041|NCT00105989|3238254|Superiority or Other|||||||0.885||||||P-value for pairwise comparison of Least Squares Means for Interference with Daily Activities Change from Baseline to Endpoint.|t-test, 2 sided||||
1764042|NCT00105989|3238254|Superiority or Other|||||||0.241||||||P-value for pairwise comparison of Least Squares Means for Shoulder Pain Change from Baseline to Endpoint.|t-test, 2 sided||||
1764043|NCT00105989|3238254|Superiority or Other|||||||0.475||||||P-value for pairwise comparison of Least Squares Means for Back Pain Change from Baseline to Endpoint.|t-test, 2 sided||||
1764044|NCT00105989|3238254|Superiority or Other|||||||0.407||||||P-value for pairwise comparison of Least Squares Means for Headache Change from Baseline to Endpoint.|t-test, 2 sided||||
1764045|NCT00105989|3238254|Superiority or Other|||||||0.792||||||P-value for pairwise comparison of Least Squares Means for Overall Pain Change from Baseline to Endpoint.|t-test, 2 sided||||
1764046|NCT00105989|3238255|Superiority or Other|||||||0.963||||||P-value for Pain While Awake Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764491|NCT00095498|3239352|Superiority or Other||||||<|0.001|||||||van Elteren Stratified Rank Test||||
1764047|NCT00105989|3238255|Superiority or Other|||||||0.346||||||P-value for Interference with Daily Activities Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764048|NCT00105989|3238255|Superiority or Other|||||||0.703||||||P-value for Shoulder Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764049|NCT00105989|3238255|Superiority or Other|||||||0.998||||||P-value for Back Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764050|NCT00105989|3238255|Superiority or Other|||||||0.968||||||P-value for Headache Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764051|NCT00105989|3238255|Superiority or Other|||||||0.273||||||P-value for Overall Pain Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764052|NCT00105989|3238255|Superiority or Other||||||<|0.001||||||P-value for all Change from Baseline to Endpoint measures in the Acute Phase were <0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764053|NCT00105989|3238256|Superiority or Other|||||||0.003||||||P-value for Pairwise comparison of Least Squares Means for Depressed Mood Subscale Change from Baseline to Endpoint.|t-test, 2 sided||||
1764054|NCT00105989|3238256|Superiority or Other|||||||0.001||||||P-value for Pairwise comparison of Least Squares Means for Sleep Subscale Change from Baseline to Endpoint.|t-test, 2 sided||||
1764055|NCT00105989|3238256|Superiority or Other|||||||0.003||||||P-value for Pairwise comparison of Least Squares Means for Retardation Subscale Change from Baseline to Endpoint.|t-test, 2 sided||||
1764056|NCT00105989|3238256|Superiority or Other|||||||0.002||||||P-value for Pairwise comparison of Least Squares Means for Maier Subscale Change from Baseline to Endpoint.|t-test, 2 sided||||
1764057|NCT00105989|3238256|Superiority or Other|||||||0.002||||||P-value for Pairwise comparison of Least Squares Means for Core Subscale Change from Baseline to Endpoint.|t-test, 2 sided||||
1764058|NCT00105989|3238256|Superiority or Other||||||<|0.001||||||P-value for Pairwise comparison of Least Squares Means for Anxiety Subscale Change from Baseline to Endpoint.|t-test, 2 sided||||
1764059|NCT00105989|3238257|Superiority or Other|||||||0.275||||||P-value for Depressed Mood Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764060|NCT00105989|3238257|Superiority or Other|||||||0.319||||||P-value for Sleep Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764061|NCT00105989|3238257|Superiority or Other||||||<|0.001||||||P-value for Retardation Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764062|NCT00105989|3238257|Superiority or Other||||||<|0.046||||||P-value for Maier Change from Baseline to Endpoint.|t-test, 2 sided|t-test assessses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764063|NCT00105989|3238257|Superiority or Other||||||<|0.019||||||P-value for Core Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764064|NCT00105989|3238257|Superiority or Other||||||<|0.334||||||P-value for Anxiety Change from Baseline to Endpoint.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764065|NCT00105989|3238257|Superiority or Other||||||<|0.001||||||P-values for Change from Baseline to Endpoint for all Subscales during Acute phase were <0.001.|t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764066|NCT00105989|3238258|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1764067|NCT00105989|3238259|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean value at endpoint is significant from 4.|||
1764068|NCT00105989|3238259|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean value at endpoint is significant from 4.|||
1764069|NCT00105989|3238260|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1764070|NCT00105989|3238261|Superiority or Other|||||||0.153|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764071|NCT00105989|3238261|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764072|NCT00105989|3238262|Superiority or Other||||||<|0.001|||||||t-test, 2 sided||||
1764073|NCT00105989|3238263|Superiority or Other|||||||0.016|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764074|NCT00105989|3238263|Superiority or Other||||||<|0.001|||||||t-test, 2 sided|t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.|||
1764075|NCT00105989|3238264|Superiority or Other|||||||0.003|||||||Cochran-Mantel-Haenszel|Frequencies were analyzed using Cochran-Mantel-Haenszel controlling for investigator.|||
1764076|NCT00105989|3238265|Superiority or Other|||||||0.003|||||||Log Rank|The log rank method provides a single p-value comparing time to depressive recurrence for placebo and duloxetine.|||
1764077|NCT00105989|3238266|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|Frequencies are analyzed using Cochran-Mantel-Haenszel controlling for investigator|||
1764103|NCT00105001|3238391|Superiority or Other (legacy)|||||||0.09||||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox||||
1764104|NCT00104650|3238409|Superiority or Other||Odds Ratio (OR)|0.36||||||95.0|0.08|1.76|||||||
1764105|NCT00104650|3238409|Superiority or Other||Odds Ratio (OR)|0.26||||||95.0|0.05|1.44|||||||
1764106|NCT00104650|3238410|Superiority or Other||Hazard Ratio (HR)|0.573||||0.43||95.0|0.143|2.289|||Regression, Cox||||
1764078|NCT00105989|3238267|Superiority or Other||||||<|0.001||||||No adjustments were made for multiple comparisons. The primary efficacy analysis compared the time to recurrence during the maintenance phase between all duloxetine and placebo patients using the log-rank test, stratified by country at α=.05.|Log Rank|The log rank method provides a single p-value comparing time to depressive recurrence for placebo and duloxetine.||A total of 257 randomized patients (randomly assigned with equal probability to the two treatment groups) were needed to have 90% power to detect 40% versus 20% recurrence rates over 52 weeks, using a log rank test at a two-sided significance level of .05.|
1764079|NCT00105443|3238301|Superiority or Other||Risk Difference (RD)|-11.95||||0.001641||95.0|-19.56|-4.35|||Cochran-Mantel-Haenszel||Sorafenib minus placebo difference|Disease control rates were compared between treatment groups using the Cochran Mantel Haenszel (CMH) test with a 1-sided alpha of 0.025, adjusting for region, ECOG PS, and “tumor burden”.|
1764080|NCT00105443|3238302|Superiority or Other||Hazard Ratio (HR)|0.5764||||7e-06||95.0|0.4484|0.741|||Log Rank||This is the sorafenib to placebo hazard ratio.|In the analysis of TTP, based on independent radiological review performed to review data up to 12 May 2006, the 2 treatment groups were compared using a 1-sided log rank test with an alpha of 0.025, stratified by region, ECOG PS, and “tumor burden”.|
1764081|NCT00105443|3238303|Superiority or Other||Hazard Ratio (HR)|1.0764||||0.7676||95.0|0.8837|1.311|||Log Rank||This is the sorafenib to placebo hazard ratio.|The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.005 stratified by region, ECOG PS and “tumor burden”. This was a co-primary endpoint with overall survival. No alpha-spending adjustments were necessary as it was only to be analyzed at the end of study.|
1764082|NCT00105443|3238304|Superiority or Other||Hazard Ratio (HR)|0.6931||||0.00583||95.0|0.5549|0.8658||According to the pre-specified O’Brien-Fleming alpha spending function, the alpha value for this second interim analysis was 0.0073 (corresponding to a nominal value of 0.0077 after taking into account the first interim analysis).|Log Rank||This is the sorafenib to placebo hazard ratio.|The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.02 stratified by region, ECOG PS and “tumor burden”. In addition to the final analysis at the end of the study, 2 formal interim analyses of overall survival were planned. An alpha spending function was used to ensure that the false positive rate is less than or equal to 0.02 (1-sided). The study was stopped at the second interim analysis, the results of which are reported here.|
1764083|NCT00105235|3238305|Superiority or Other||Proportion|0.1|||||2-Sided|95.0|0.01|0.2|||||||
1764084|NCT00105235|3238306|Superiority or Other||Proportion|0.2|||||2-Sided|95.0|0.04|0.3|||||||
1764085|NCT00105235|3238308|Superiority or Other||Proportion|0.0|||||2-Sided|95.0|0.0|0.3|||||||
1764086|NCT00105235|3238309|Superiority or Other||Proportion|0.22|||||2-Sided|95.0|0.086|0.423|||||||
1764087|NCT00105196|3238310|Superiority or Other||Ratio of remission|1.95|||<|0.001||95.0|1.36|2.8||No adjustment for multiple comparisons was implemented for this secondary endpoint.|CMH General Association Test||aripiprazole/placebo||
1764088|NCT00105196|3238311|Superiority or Other||Ratio of response|1.43|||<|0.001||95.0|1.17|1.74||No adjustment for multiple comparisons was implemented for this secondary endpoint.|ANCOVA||aripiprazole/placebo||
1764089|NCT00105196|3238312|Superiority or Other||Ratio of response|1.74|||<|0.001||95.0|1.31|2.32||No adjustment for multiple comparisons was implemented for this secondary endpoint.|CMH General Association Test||aripiprazole/placebo||
1764090|NCT00105196|3238313|Superiority or Other||Mean Difference (Final Values)|-0.08||||0.792||95.0|-0.67|0.51||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided||||
1764091|NCT00105196|3238314|Superiority or Other||Mean Difference (Final Values)|-0.57||||0.037||95.0|-1.1|-0.03||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided||||
1764092|NCT00105196|3238315|Superiority or Other||Mean Difference (Final Values)|-0.53||||0.052||95.0|-1.06|0.0||No adjustment for multiple comparisons was implemented for this secondary endpoint.|t-test, 2 sided||||
1764093|NCT00105196|3238316|Superiority or Other||Mean Difference (Final Values)|-0.42||||0.075||95.0|-0.88|0.04|||t-test, 2 sided|||To protect the overall (primary and key secondary efficacy analysis) alpha level of 0.05, for this key secondary endpoint a hierarchical testing procedure was followed such that formal testing would take place conditional on the primary efficacy analysis showing a statistically significant difference.|
1764094|NCT00105196|3238317|Superiority or Other||Mean Difference (Final Values)|-3.73|||<|0.001||95.0|-5.44|-2.02|||t-test, 2 sided|||The sample size for the study was based on the primary outcome measure. The study was powered at 90% to detect a treatment difference between adjunctive aripiprazole and adjunctive placebo of 3.75, assuming a standard deviation of 10.5 and a two-sided alpha level of 0.05. The null-hypothesis was the lack of a treatment difference.|
1764095|NCT00105001|3238387|Superiority or Other (legacy)|||||||0.96||||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox||||
1764096|NCT00105001|3238388|Superiority or Other (legacy)|||||||0.93||||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox||||
1764097|NCT00105001|3238389|Superiority or Other (legacy)||Hazard Ratio (HR)|0.47||||0.004|2-Sided|95.0|0.3|0.8|||Regression, Cox||HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up||
1764098|NCT00105001|3238389|Superiority or Other (legacy)||Hazard Ratio (HR)|0.86||||0.51|2-Sided|95.0|0.5|1.4|||Regression, Cox||HR for Arm II relative to Arm I, reflecting events over the entire period of follow-up||
1764099|NCT00105001|3238389|Superiority or Other (legacy)|||||||0.009||||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox||||
1764100|NCT00105001|3238390|Superiority or Other (legacy)|||||||0.55||||||Overall test of homogeneity among arms, reflecting events over the entire period of follow-up|Regression, Cox||||
1764101|NCT00105001|3238391|Superiority or Other (legacy)||Hazard Ratio (HR)|0.62||||0.04|2-Sided|95.0|0.6|1.0|||Regression, Cox||HR for Arm III relative to Arm I, reflecting events over the entire period of follow-up||
1764102|NCT00105001|3238391|Superiority or Other (legacy)||Hazard Ratio (HR)|0.69||||0.1|2-Sided|95.0|0.4|1.1|||Regression, Cox||HR for Arm II relative to Arm I, reflecting events over the entire period of follow-u[||
1764107|NCT00104650|3238410|Superiority or Other||Hazard Ratio (HR)|0.162||||0.105||95.0|0.018|1.465|||Regression, Cox||||
1764108|NCT00104650|3238411|Superiority or Other|||||||0.056|||||||ANCOVA|Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)|||
1764109|NCT00104650|3238412|Superiority or Other||Hazard Ratio (HR)|0.199||||0.001||95.0|0.076|0.523|||Regression, Cox|Adjusted for cancer type stratification factor and screening uNTx level|||
1764110|NCT00104650|3238412|Superiority or Other||Hazard Ratio (HR)|0.274||||0.006||95.0|0.11|0.687|||Regression, Cox|Adjusted for cancer type stratification factor and screening uNTx level|||
1764111|NCT00104650|3238413|Superiority or Other||Hazard Ratio (HR)|4.32|||<|0.001||95.0|2.23|8.36|||Regression, Cox|Stratified by cancer type and screening uNTx level|||
1764112|NCT00104650|3238413|Superiority or Other||Hazard Ratio (HR)|3.79|||<|0.001||95.0|2.01|7.15|||Regression, Cox|Stratified by cancer type and screening uNTx level|||
1764113|NCT00104650|3238414|Superiority or Other|||||||0.388|||||||ANCOVA|Adjusted for the stratum to which participants were originally assigned by the Interactive Voice Response System (IVRS)|||
1764114|NCT00104650|3238415|Superiority or Other||Percentage of participants|37.1||||||95.0|21.5|55.1|||||||
1764115|NCT00104650|3238415|Superiority or Other||Percentage of participants|63.6||||||95.0|45.1|79.6|||||||
1764116|NCT00104650|3238415|Superiority or Other||Percentage of participants|63.9||||||95.0|46.2|79.2|||||||
1764117|NCT00104650|3238416|Superiority or Other||Percentage of participants|28.6||||||95.0|14.6|46.3|||||||
1764118|NCT00104650|3238416|Superiority or Other||Percentage of participants|63.6||||||95.0|45.1|79.6|||||||
1764119|NCT00104650|3238416|Superiority or Other||Percentage of participants|77.8||||||95.0|60.8|89.9|||||||
1764120|NCT00104650|3238416|Superiority or Other||Odds Ratio (OR)|5.33||||0.002||95.0|1.74|16.36|||Cochran-Mantel-Haenszel|Adjusted for cancer type stratification factor|||
1764121|NCT00104650|3238416|Superiority or Other||Odds Ratio (OR)|12.28|||<|0.001||95.0|3.35|45.03|||Cochran-Mantel-Haenszel|Adjusted for cancer type stratification factor|||
1764122|NCT00104520|3238434|Superiority or Other||Mean Difference (Final Values)|-0.659||||0.0059|2-Sided|95.0|-1.125|-0.193|||ANCOVA|ANCOVA model included terms for treatment and baseline highest MIC of aztreonam for PA (<=2, 4-8, 16-128 or >=256 μg/mL) value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in mean change from baseline in log10 PA CFUs in sputum.|
1764123|NCT00104520|3238436|Superiority or Other||Mean Difference (Final Values)|6.28||||0.0012|2-Sided|95.0|2.5|10.06||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment and baseline value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in percent change from baseline in FEV1 (L).|
1764124|NCT00104520|3238437|Superiority or Other||Mean Difference (Final Values)|5.01||||0.0196|2-Sided|95.0|0.81|9.21||No adjustments were made for multiple comparisons.|ANCOVA|ANCOVA model included terms for treatment and baseline value.||Null hypothesis was there is no difference between 75 mg AZLI and placebo (pooled treatment groups) in change from baseline in CFQ-R RSS scores.|
1764125|NCT00104520|3238438|Superiority or Other|||||||0.007||||||Analysis based on 2-sided test with 0.05 a priori threshold for statistical significance. No adjustments were made for multiple comparisons.|Log Rank|||H0: no difference between AZLI and placebo (pooled treatment groups) in time to need for inhaled or IV antibiotics. Assuming 2-sided significance level of 0.05, ~210 subjects (70 in each AZLI group, 35 in each placebo group) provided >90% power to reject null hypothesis based on Lakatos normal approximation method with weights being one. Therefore, 250 subjects were to be randomized at Visit 2 (Day -28) to ensure at least 210 participants entered double-blind treatment period at Day 0.|
1764126|NCT00104416|3238455|Superiority or Other||Median Difference (Final Values)|31.6|||<|0.0001||95.0|15.8|48.1|||Cochran-Mantel-Haenszel||||
1764127|NCT00104299|3238456|Superiority or Other|||||||0.504|||||||Chi-squared|||Proportions of subjects experiencing a serious adverse event through 18 months and prior to censoring for open-label, crossover, or best medical judgment according to originally assigned treatment arm were compared using a two-sided Chi-squared test.|
1764128|NCT00104299|3238457|Superiority or Other||Cox Proportional Hazard|1.3||||0.147|2-Sided|95.0|0.9|1.8|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the pattern of achieving complete remission|The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.||
1764129|NCT00104299|3238458|Superiority or Other||Cox Proportional Hazard|1.0||||0.497|2-Sided|95.0|0.7|1.3|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the pattern of achieving remission|The hazard ratio and confidence interval are based on a Cox proportional hazard model comparing rituximab to the control group, adjusting for clinical study site, ANCA type, and glucocorticoid use prior to baseline.||
1764130|NCT00104299|3238459|Superiority or Other||Cox Proportional Hazard|0.9||||0.861|2-Sided|95.0|0.6|1.5|||Log Rank|The log-rank test assesses the difference between the two treatment arms in the flaring pattern after remission||Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit|
1764131|NCT00104299|3238460|Superiority or Other||Cox Proportional Hazard|0.9||||0.761|2-Sided|95.0|0.5|1.7||The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission|Log Rank|The log-rank test assesses the difference between the two treatment arms in the flaring pattern after complete remission||Participants are censored at the time of crossover, open label rituximab, or best medical judgement, if applicable. If a participant has no flare after complete remission prior to their Month 18 visit, the duration is censored at the date of the Month 18 Visit|
1764132|NCT00104299|3238461|Superiority or Other||95.1% Confidence Interval of Difference|10.6||||0.133|2-Sided|95.1|-3.2|24.4|||Chi-squared|At 6 months, the confidence interval is 95.1%.||The p-value is from a chi-square test.|
1764154|NCT00102960|3238577|Superiority or Other||Hazard Ratio (HR)|0.47||||0.002|2-Sided|95.0|0.27|0.76|||Regression, Cox|||Statistical analysis compares early therapy 96 weeks (ART-96W) relative to deferred therapy (ART-Def)|
1764492|NCT00095498|3239352|Superiority or Other||||||<|0.001|||||||van Elteren Stratified Rank Test||||
1764133|NCT00104299|3238462|Superiority or Other|||||||0.927||||||P-value is from the Poisson regression model adjusting for clinical study site and ANCA type. The natural logarithm of participant-months is used as an offset in this model|Poisson regression model|||Participant-months are defined as duration in months from the first study drug dosing date to the last date of the participant in the protocol. The rate of selected AEs is defined as the total number of selected AEs divided by total participant-months, and indicates the number of events per participant per month on average. Participants are grouped according to their originally received treatment.|
1764134|NCT00104299|3238463|Non-Inferiority or Equivalence|non-inferiority margin of -20%|Difference between group success rates|10.6|||<|0.001||95.1|-3.2|24.3||P-value is adjusted for interim analysis using a Lan-DeMets alpha spending function with an O’Brien-Fleming boundary, allocating 0.003 alpha to the interim analysis and 0.049 alpha to the final analysis.|95.1% CI of difference|Calculate 95.1% CI around the difference in success rates between arms. Lower bound above non-inferiority margin of -20% indicates non-inferiority.||In calculating the sample size, we assumed that the percentage of patients in both treatment groups would achieve disease remission off prednisone by 6 months was 70%. We specified a non-inferiority margin of -20% on the difference in remission rates (rituximab rate minus cyclophosphamide rate) and a one-sided 0.025 level test. Assuming a 10% dropout rate, RAVE required 100 patients in each arm to have 83% power to conclude non-inferiority.|
1764135|NCT00104247|3238464|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1764136|NCT00104052|3238473|Superiority or Other||Normal approximation to the binomial|0.654||||||95.0|0.564|0.744|||||||
1764137|NCT00103285|3238539|Other||Odds Ratio (OR)|4.1|||||2-Sided|95.0|1.31|12.73||||||Parents of 159 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the BASC-2 Anxiety Scale at 1 month after diagnosis, and 3 months post-therapy. Of these 159 had data at 1 month after diagnosis and 96 at 3 months post therapy.|
1764138|NCT00103285|3238540|Superiority or Other (legacy)||Odds Ratio (OR)|0.131|||||2-Sided|95.0|0.101|0.17||||||MRD status ( positive vs. negative) was correlated with Early Marrow Status (M1 vs M2/M3) using Chi Square test.|
1764139|NCT00103285|3238542|Superiority or Other (legacy)||Hazard Ratio (HR)|2.542|||||2-Sided|95.0|1.974|3.273||||||4981 eligible evaluable patients enrolled on AALL0331 had MRD evaluation at Day 29 of induction. MRD status defined as negative (<0.1%) or positive (>=0.1%). MRD status ( positive vs. negative) was correlated with EFS using Cox regression analysis.|
1764140|NCT00103285|3238543|Superiority or Other (legacy)||Odds Ratio (OR)|1.85|||||2-Sided|95.0|1.03|3.34|||||Odds Ratios in this Statistical Analysis corresponds to all four time points|Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.|
1764141|NCT00103285|3238543|Superiority or Other (legacy)||Odds Ratio (OR)|1.99|||||2-Sided|95.0|1.21|3.27|||||Odds Ratios in this Statistical Analysis corresponds to all four time points|Social Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.|
1764142|NCT00103285|3238543|Superiority or Other (legacy)||Odds Ratio (OR)|5.17|||||2-Sided|95.0|1.61|16.63|||||Odds Ratios in this Statistical Analysis corresponds to all four time points.|Physical Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.|
1764143|NCT00103194|3238557|Superiority or Other|||||||0.006|||||||Mixed Models Analysis|The analysis is testing the null hypothesis that there is no difference between the pre-treatment and post-treatment PSA slopes.|||
1764144|NCT00103194|3238558|Superiority or Other||PSA response rate|0.0|||||2-Sided|90.0|0.0|8.2|||||||
1764145|NCT00102960|3238564|Superiority||Hazard Ratio (HR)|0.583||||0.0038|2-Sided|95.0|0.405|0.84|||Regression, Cox||||
1764146|NCT00102960|3238564|Superiority||Hazard Ratio (HR)|0.562||||0.0021|2-Sided|95.0|0.389|0.811|||Regression, Cox||||
1764147|NCT00102960|3238565|Superiority||Count of days|0.0||||0.004|2-Sided|||||The p-value here compares the days spent in hospital across the three arms|Poisson regression||||The total number of days/count of days: 1018 (Arm 1), 533 (Arm 2) and 414 (Arm 3) were compared across the three groups by Poisson regression analysis.
1764148|NCT00102960|3238567|Superiority or Other||Hazard Ratio (HR)|0.34||||0.0009|2-Sided|95.0|0.18|0.64|||Regression, Cox||The hazard ratio compares ART-96W relative to the ART-Def arm.|The analysis compares ART-96 Weeks relative to ART-Deferred|
1764149|NCT00102960|3238567|Superiority or Other||Hazard Ratio (HR)|0.48||||0.011|2-Sided|95.0|0.27|0.84|||Regression, Cox||Hazard rate reported above compares early therapy 40 weeks relative to the deferred therapy arm.|The analysis compares ART-40W relative to the ART-Def arm.|
1764150|NCT00102960|3238570|Superiority||Rate per 100 person years|0.0||||0.46|2-Sided||||||Poisson regression|||The event rates per 100 person years were compared across the three arms|The laboratory events per 100 person years across the three arms were: 7 (Deferred arm), 8.1 (early therapy for 40 weeks) and 6 (early therapy for 96 weeks).
1764151|NCT00102960|3238571|Superiority or Other||Rate per 100 person years|0.0|||<|0.0001|2-Sided|||||This p-value compares event rates per 100 person-years across the three arms|Poisson Regression|||The CHER study compared Grade 3 or 4 clinical event rates per 100 person-years between the three arms using Poisson regression modeling over the study duration of 4.8 years.|The rates per 100 person-years were 33.8 (Arm 1), 21.6 (Arm 2) and 16 (Arm 3)
1764152|NCT00102960|3238572|Superiority||Kaplan-Meier Cummulative Probability|0.2||||0.0006|2-Sided|95.0|0.09|0.31|||Proportion test|||Relative to ART-Def, ART-96W had a 13% difference in the cumulative probability of clinical disease progression or death at 3·5 years|
1764153|NCT00102960|3238572|Superiority or Other||Kaplan-Meier Cummulative Probability|0.13||||0.03|2-Sided|95.0|0.01|0.25|||Proportion test|||Relative to ART-Def, ART-40W had a 13% difference in the cumulative probability of clinical disease progression or death at 3·5 years|
1764155|NCT00102960|3238577|Superiority or Other||Hazard Ratio (HR)|0.59||||0.02|2-Sided|95.0|0.38|0.93|||Regression, Cox|||Statistical analysis compares early therapy 40 weeks (ART-40W) relative to deferred therapy (ART-Def)|
1764156|NCT00102440|3238612|Superiority or Other|||||||0.266||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact||||
1764157|NCT00102440|3238612|Superiority or Other|||||||0.229||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact||||
1764158|NCT00102440|3238612|Superiority or Other||||||>|0.999||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact||||
1764159|NCT00102440|3238613|Superiority or Other|||||||0.719||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764160|NCT00102440|3238613|Superiority or Other|||||||0.444||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764161|NCT00102440|3238613|Superiority or Other|||||||0.657||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764162|NCT00102440|3238614|Superiority or Other|||||||0.362||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764163|NCT00102440|3238614|Superiority or Other|||||||0.188||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764164|NCT00102440|3238614|Superiority or Other|||||||0.507||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764165|NCT00102440|3238615|Superiority or Other|||||||0.411||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764166|NCT00102440|3238615|Superiority or Other|||||||0.32||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764167|NCT00102440|3238615|Superiority or Other|||||||0.674||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764168|NCT00102440|3238616|Superiority or Other|||||||0.246||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764169|NCT00102440|3238616|Superiority or Other|||||||0.372||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764170|NCT00102440|3238616|Superiority or Other|||||||0.08||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764171|NCT00102440|3238617|Superiority or Other|||||||0.619||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764172|NCT00102440|3238617|Superiority or Other|||||||0.164||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764173|NCT00102440|3238617|Superiority or Other|||||||0.083||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764174|NCT00102440|3238618|Superiority or Other|||||||0.024||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764175|NCT00102440|3238618|Superiority or Other|||||||0.011||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764176|NCT00102440|3238618|Superiority or Other||||||>|0.999||||||P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|Wilcoxon (Mann-Whitney)||||
1764177|NCT00102440|3238619|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA||||
1764178|NCT00102440|3238619|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA||||
1764179|NCT00102440|3238619|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA||||
1764180|NCT00102440|3238620|Superiority or Other|||||||0.006||||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA||||
1764181|NCT00102440|3238620|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA||||
1764182|NCT00102440|3238620|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA||||
1764183|NCT00102440|3238621|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA||||
1764184|NCT00102440|3238621|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA||||
1764185|NCT00102440|3238621|Superiority or Other||||||<|0.001||||||P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons.|ANOVA||||
1764186|NCT00102440|3238622|Superiority or Other|||||||0.164||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact||||
1764187|NCT00102440|3238622|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact||||
1764188|NCT00102440|3238622|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact||||
1764189|NCT00102440|3238623|Superiority or Other|||||||0.883||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact||||
1764190|NCT00102440|3238623|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact||||
1764191|NCT00102440|3238623|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact||||
1764192|NCT00102440|3238624|Superiority or Other|||||||0.031||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact||||
1764193|NCT00102440|3238624|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact||||
1764194|NCT00102440|3238624|Superiority or Other||||||<|0.001||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact||||
1764195|NCT00102440|3238625|Superiority or Other|||||||0.072||||||Statistical significance was determined at 0.05 level without adjustment for multiple comparisons.|Fisher Exact||||
1764196|NCT00102440|3238625|Superiority or Other||||||<|0.001||||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.|Fisher Exact||||
1764197|NCT00102440|3238625|Superiority or Other||||||<|0.001||||||Comparisons of each febuxostat dose to allopurinol were adjusted to control the overall 0.05 level of significance for superiority by using Hochberg's method for multiple comparisons.|Fisher Exact||||
1764198|NCT00102440|3238625|Non-Inferiority or Equivalence|Non-inferiority of febuxostat 120 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is > -10%.|Difference in percentage|41.0|||<|||97.5|31.5|49.5|||||||
1764199|NCT00102440|3238625|Non-Inferiority or Equivalence|Non-inferiority of febuxostat 80 mg to allopurinol was declared if the value of the lower bound of the 97.5% confidence interval is > -10%.|Difference in percentage|32.0|||<|||97.5|23.1|41.3|||||||
1764200|NCT00102063|3238633|Superiority or Other|||||||0.007|||||||t-test, 2 sided||||
1764201|NCT00102063|3238633|Superiority or Other|||||||0.05|||||||t-test, 2 sided||||
1764202|NCT00101933|3238634|Superiority or Other|||||||0.047|||||||Wilcoxon (Mann-Whitney)|||Numbers provided indicate the percentage change from baseline in seizure frequency of each participant's most severe seizures. Negative values indicate improvement from baseline.|
1764203|NCT00101933|3238635|Superiority or Other|||||||0.0387||||||Since a visit-by-treatment interaction did not remain in the final model, the results shown are for the entire blinded phase.|Generalized Estimating Equations|This analysis is adjusted for significant baseline covariates.||The numbers presented are the percentage reduction in the number of seizures in each group. A negative percentage change indicates a seizure reduction.|
1764204|NCT00101933|3238636|Superiority or Other|||||||1|||||||Fisher Exact||||
1764205|NCT00101933|3238637|Superiority or Other|||||||0.498|||||||Wilcoxon (Mann-Whitney)||||
1764206|NCT00101933|3238638|Superiority or Other|||||||0.105|||||||Wilcoxon (Mann-Whitney)||||
1764207|NCT00101933|3238639|Superiority or Other|||||||0.83|||||||Fisher Exact|||Fisher's Exact test. The numbers presented in this analysis are the number of subjects who were responders based on a responder definition including all subjects with 50% or greater improvement in total seizure count.|
1764208|NCT00101933|3238640|Superiority or Other||Rate per 1000 years of stimulation|4.9|||||2-Sided|95.0|0.6|17.79|||||The rate is calculated per 1000 subject years of follow-up based on 406 subject years of stimulation. The confidence interval is the 95% Poisson confidence interval. Per protocol, only definite and probable SUDEP were included in the calculation.||
1764209|NCT00101933|3238642|Superiority or Other|||||||0.0017||||||Since a treatment-by-visit interaction remains in the final model, the results were analyzed by visit. The results shown are for the last month in the blinded phase (month 3-4).|Generalized Estimating Equations|This analysis is adjusted for significant baseline covariates.||The numbers presented are the percentage reduction in the number of seizures in each group. A negative percentage change indicates a seizure reduction.|
1764210|NCT00101686|3238683|Superiority or Other||Hazard Ratio (HR)|1.794||||0.037||95.0|1.12|2.88|||Log Rank||||
1764211|NCT00101686|3238685|Superiority or Other|||||||0.7388|||||||Cochran-Mantel-Haenszel||||
1764212|NCT00101686|3238685|Superiority or Other||F-distribution method|53.3||||||95.0|40.0|66.33|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)||
1764213|NCT00101686|3238685|Superiority or Other||F-distribution method|57.9||||||95.0|44.08|70.86|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)||
1764217|NCT00101686|3238688|Superiority or Other||F-distribution method|46.5||||||95.0|39.76|53.42|||||confidence interval for binomial proportion using the F-distribution method (unit: %)||
1764218|NCT00101686|3238688|Superiority or Other||F-distribution method|39.4||||||95.0|32.83|46.34|||||confidence interval for binomial proportion using the F-distribution method (unit: %)||
1764219|NCT00101686|3238689|Superiority or Other||Hazard Ratio (HR)|1.068||||0.7163||95.0|0.86|1.33|||Log Rank||||
1764220|NCT00101686|3238691|Superiority or Other||Hazard Ratio (HR)|1.049||||0.9364||95.0|0.8|1.38|||Log Rank||||
1764221|NCT00101686|3238691|Superiority or Other||Hazard Ratio (HR)|1.19||||0.2765||95.0|0.9|1.58|||Log Rank||||
1764222|NCT00101686|3238691|Superiority or Other||Hazard Ratio (HR)|1.268||||0.0879||95.0|0.96|1.68|||Log Rank||||
1764223|NCT00101686|3238692|Superiority or Other|||||||0.4395|||||||Cochran-Mantel-Haenszel||||
1764224|NCT00101686|3238692|Superiority or Other|||||||0.1591|||||||Cochran-Mantel-Haenszel||||
1764225|NCT00101686|3238692|Superiority or Other|||||||0.4751|||||||Cochran-Mantel-Haenszel||||
1764226|NCT00101686|3238692|Superiority or Other||F-distribution method|38.6||||||95.0|30.66|47.06|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)||
1764227|NCT00101686|3238692|Superiority or Other||F-distribution method|43.3||||||95.0|34.95|51.86|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)||
1764228|NCT00101686|3238692|Superiority or Other||F-distribution method|47.2||||||95.0|38.85|55.71|||||Exact confidence interval for binomial proportion using the F-distribution method (unit: %)||
1764229|NCT00101686|3238693|Superiority or Other||Hazard Ratio (HR)|1.057||||0.4659||95.0|0.81|1.38|||Log Rank||||
1764230|NCT00101686|3238693|Superiority or Other||Hazard Ratio (HR)|1.368||||0.0156||95.0|1.04|1.8|||Log Rank||||
1764231|NCT00101686|3238693|Superiority or Other||Hazard Ratio (HR)|1.512||||0.0042||95.0|1.16|1.97|||Log Rank||||
1764232|NCT00101686|3238694|Superiority or Other||Hazard Ratio (HR)|1.433||||0.0152||95.0|1.09|1.89||p-value corresponds to the log-rank test for comparing Kaplan-Meier survival curves.|Log Rank||Hazard ratio [mIRI:FOLFIRI] is from the Cox Proportional Hazard Model using treatment (FOLFIRI, mIRI, CapeIRI), age (<=70 vs >70), performance status (0 vs 1), aspirin (Yes vs No), celecoxib (Yes or No) as the covariates.||
1764233|NCT00101582|3238724|Superiority or Other|||||||0.9587||||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel||||
1764234|NCT00101582|3238724|Superiority or Other||Chi-Square Statistic|0.0027||||0.9587||95.0||||Generalized Cochran-Mantel-Haenszel test for general association.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).|||
1764235|NCT00101582|3238725|Superiority or Other|||||||0.6835||||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel||||
1764236|NCT00101582|3238725|Superiority or Other||Chi-Square Statistic|0.9039||||0.3417||95.0||||Generalized Cochran-Mantel-Haenszel test for general association|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).|||
1764237|NCT00101582|3238726|Superiority or Other|||||||0.6835||||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel||||
1764238|NCT00101582|3238726|Superiority or Other||Chi-Square Statistic|1.3901||||0.2384||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).|||
1764239|NCT00101582|3238727|Superiority or Other|||||||0.2849||||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel||||
1764240|NCT00101582|3238727|Superiority or Other||Chi-Square Statistic|3.2548||||0.0712||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).|||
1764241|NCT00101582|3238728|Superiority or Other|||||||0.2314||||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel||||
1764242|NCT00101582|3238728|Superiority or Other||Chi-Square Statistic|3.9715||||0.0463||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed to have the event.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).|||
1764243|NCT00101582|3238729|Superiority or Other|||||||0.1566||||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Stratified Log-Rank test||||
1764244|NCT00101582|3238729|Superiority or Other||Hazard Ratio (HR)|0.6603||||0.0261|2-Sided|95.0|0.4546|0.9592|||Stratified Log-Rank test|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).|Hazard ratio of palifermin over placebo based on Stratified Cox proportional hazard model.||
1764245|NCT00101582|3238730|Superiority or Other|||||||0.1122||||||Adjusted p-value was based on Hochberg procedure to control for the Type 1 error.|Cochran-Mantel-Haenszel|||To protect the overall type 1 error, the Hochberg procedure was used to adjust for multiple statistical testing of the secondary efficacy endpoints.|
1764246|NCT00101582|3238730|Superiority or Other||Chi-Square Statistic|5.8002||||0.016||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).|||
1764270|NCT00099047|3238862|Superiority or Other||Median Difference (Final Values)|0.05|Standard Deviation|0.05||0.23|2-Sided||||||SAS version 8||36 evaluable patients randomized 1:1 to each treatment was planned in order to have >77% power to detect differences in above parameters equal to or greater than one standard deviation, based on a 2-sided Wilcoxon rank-sum test with .05 Type I error.||
1764271|NCT00098748|3238903|Superiority or Other||Least squares mean|-0.284|Standard Error of the Mean|0.2445|||2-Sided|95.0|-0.767|0.199||||||MVC BID vs PBO treatment difference at Week 48.|
1764247|NCT00101582|3238731|Superiority or Other||Chi-Square Statistic|4.1764||||0.041||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants having no assessment were assumed as having WHO grade 3 or 4 oral mucositis in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage (III versus IV) and primary anatomical tumor location (oral cavity / oropharynx vs. nasopharynx vs. hypopharynx / larynx).||Sample size calculations were based on the number of participants needed to detect, with 90% power and 5% type 1 error rate, at least a 25% difference in the incidence of severe OM between the treatment groups. A 25% absolute reduction in the incidence of severe OM from the placebo group was considered by investigators as clinically meaningful in this clinical setting.|
1764248|NCT00101452|3238732|Superiority or Other||||||<|0.05|||||||ANOVA||||
1764249|NCT00101439|3238733|Superiority or Other||Geometric Mean Ratio (GMR)|1.02||||0.812|2-Sided|95.0|0.87|1.2||Data were back-transformed from the log scale and adjusted for treatment|ANOVA||GMR=Ezetimibe divided by placebo||
1764250|NCT00101439|3238734|Superiority or Other||Geometric Mean Ratio (GMR)|0.89||||0.241|2-Sided|95.0|0.73|1.08||Data were back-transformed from the log scale and adjusted for treatment|ANOVA||GMR=Ezetimibe divided by placebo||
1764251|NCT00101361|3238746|Non-Inferiority or Equivalence|the required sample size of 400 participants provided 85% power to detect an increase in healing from 25% in the placebo group to 40% in the oxandrolone group, as assuming a 0.05 (2-sided) type I error, 13% rate of loss to follow up, and a test of proportions by using an arcsine transformation.|Mean Difference (Final Values)|-5.7|||<|0.05|2-Sided|95.0|-17.5|6.8|||Cochran-Mantel-Haenszel|||For spinal cord injury patients with a Stage III or IV pressure ulcer of the pelvic region who receive 24 weeks or less of optimized clinical care (i.e., guideline-driven care with nutritional support) compared with optimized clinical care and an oral anabolic steroid agent (oxandrolone) there will be no difference in the percent of healed pressure ulcers.|
1764252|NCT00101283|3238749|Superiority or Other||Overall Response Percent|0.0|||||2-Sided|90.0|0.0|20.6|||||Overall response percent for Pemetrexed/Gemcitabine arm (percent of eligible, treated patients with complete or partial response)|The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.|
1764253|NCT00101283|3238749|Superiority or Other||Overall Response Percent|18.8|||||2-Sided|90.0|5.4|41.7|||||Overall response percent for Pemetrexed/Carboplatin arm (percent of eligible, treated patients with complete or partial response)|The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.|
1764254|NCT00100698|3238799|Superiority or Other||Mean Difference (Net)|-22.0|Standard Error of the Mean|6.0||0.049|2-Sided|95.0|-38.0|-0.5|||repeated measures mixed effects ANCOVA||||
1764255|NCT00100230|3238802|Non-Inferiority or Equivalence|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||8e-06||||||Threshold for significance: p<0.05|Mixed Models Analysis||||
1764256|NCT00100230|3238803|Non-Inferiority or Equivalence|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.27|||||||Mixed Models Analysis||||
1764257|NCT00100230|3238803|Non-Inferiority or Equivalence|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.27||||||Threshold for significance: p<0.05|Mixed Models Analysis||||
1764258|NCT00100230|3238804|Non-Inferiority or Equivalence|Equivalence analysis: standard power calculation of 20%; used 2-sided t-test||||||0.3||||||Threshold for significance: p<0.05|Mixed Models Analysis||||
1764259|NCT00100178|3238805|Superiority or Other (legacy)|||||||0.47|||||||ANCOVA|||The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the “AUC mean” and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.|
1764260|NCT00099632|3238839|Superiority or Other|||||||0.091|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by treatment duration and the actual receipt of antenatal ZDV||Compare proportion of women with new NNRTI-resistant variants among ARV regimens (3TC/ZDV vs. FTC/TDF vs. LPV/r), pooled over treatment durations 7-day and 21-day, stratified by treatment duration and the actual receipt of antenatal ZDV|
1764261|NCT00099632|3238839|Superiority or Other|||||||0.37|||||||Cochran-Mantel-Haenszel|Cochran-Mantel-Haenszel test stratified by ARV regimen and the actual receipt of antenatal ZDV||Compare proportion of women with new NNRTI-resistant variants between treatment durations (7-day vs. 21 day), pooled over ARV regimens (3TC/ZDV, FTC/TDF, and LPV/r), stratified by ARV regimen and the actual receipt of antenatal ZDV|
1764262|NCT00099359|3238849|Superiority or Other||Odds Ratio (OR)|2.28|||<|0.0001|2-Sided|95.0|1.56|3.35||Adjusted odds ratio for the association of continuous log10 viral load with intrapartum infection status|Regression, Logistic||||
1764263|NCT00099359|3238849|Superiority or Other||Odds Ratio (OR)|2.51|||<|0.03|2-Sided|95.0|1.08|5.86|||Regression, Logistic|"Adjusted odds ratio for association of illegal substance use during pregnancy and intrapartum HIV infection status with NO being reference group."|||
1764264|NCT00099359|3238849|Superiority or Other||Odds Ratio (OR)|0.39|||<|0.01|2-Sided|95.0|0.19|0.82||Adjusted odds ratio for association of treatment arm B (ZDV+NVP) with intrapartum infection status with Treatment Arm A (ZDV only) as reference.|Regression, Logistic||||
1764265|NCT00099359|3238849|Superiority or Other||Odds Ratio (OR)|0.5|||<|0.05|2-Sided|95.0|0.24|1.01|||Regression, Logistic|Adjusted Odds ratio for treatment arm C (ZDV+3TC/NFV) association with Intrapartum Infection Status with Treatment Arm A (ZDV only) as reference group|||
1764266|NCT00099359|3238852|Superiority or Other|||||||0.49|||||||Chi-squared||||
1764267|NCT00099359|3238853|Superiority or Other|||||||0.2432|||||||multiple comparison||||
1764268|NCT00099359|3238854|Superiority or Other|||||||0.0001|||||||Chi-squared||||
1764269|NCT00099359|3238855|Superiority or Other|||||||0.046||||||Overall comparison of 3 KM curves using an extension of the M-H test was performed. Results indicated a significant difference therefore a 2nd stage analysis was done to compare each pair of transmission rates, using 2-sample Mantel-Haenzel tests.|multiple comparison|Hochberg’s modified Bonferroni method was used to adjust the significance level for comparisons between arms.|||
1764272|NCT00098748|3238903|Superiority or Other||Least squares mean|0.209|Standard Error of the Mean|0.2388|||2-Sided|95.0|-0.262|0.681||||||MVC QD vs PBO treatment difference at Week 48.|
1764273|NCT00098748|3238903|Superiority or Other||Least squares mean|-0.218|Standard Error of the Mean|0.2413|||2-Sided|95.0|-0.694|0.258||||||MVC BID vs PBO treatment difference at Week 24.|
1764274|NCT00098748|3238903|Superiority or Other||Least squares mean|0.069|Standard Error of the Mean|0.2356|||2-Sided|95.0|-0.396|0.535||||||MVC QD vs PBO treatment difference at Week 24.|
1764275|NCT00098748|3238904|Superiority or Other|||||||0.6657|||||||Log Rank|||MVC BID vs PBO at Week 48. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.|
1764276|NCT00098748|3238904|Superiority or Other|||||||0.8243|||||||Log Rank|||MVC QD vs PBO at Week 48. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.|
1764277|NCT00098748|3238904|Superiority or Other|||||||0.254|||||||Log Rank|||MVC BID vs PBO at Week 24. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.|
1764278|NCT00098748|3238904|Superiority or Other|||||||0.7524|||||||Log Rank|||MVC QD vs PBO at Week 24. Kaplan-Meier survival estimates. TX difference evaluated by log-rank test.|
1764279|NCT00098748|3238905|Superiority or Other||Least squares mean|182.91|Standard Error of the Mean|90.174|||2-Sided|95.0|4.81|361.02|||||Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.|
1764280|NCT00098748|3238905|Superiority or Other||Least squares mean|155.94|Standard Error of the Mean|87.304|||2-Sided|95.0|-16.49|328.37|||||Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.|
1764281|NCT00098748|3238905|Superiority or Other||Least squares mean|188.817|Standard Error of the Mean|83.4484|||2-Sided|95.0|23.999|353.635|||||Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.|
1764282|NCT00098748|3238905|Superiority or Other||Least squares mean|234.499|Standard Error of the Mean|80.799|||2-Sided|95.0|74.913|394.084|||||Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 24.|
1764283|NCT00098748|3238906|Superiority or Other||Least squares mean|27.71|Standard Error of the Mean|16.754|||2-Sided|95.0|-5.38|60.8|||||Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.|
1764284|NCT00098748|3238906|Superiority or Other||Least squares mean|14.61|Standard Error of the Mean|16.412|||2-Sided|95.0|-17.8|47.03|||||Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.|
1764285|NCT00098748|3238906|Superiority or Other||Least squares mean|26.679|Standard Error of the Mean|13.0678|||2-Sided|95.0|0.869|52.49|||||Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.|
1764286|NCT00098748|3238906|Superiority or Other||Least squares mean|23.927|Standard Error of the Mean|12.8025|||2-Sided|95.0|-1.359|49.213|||||Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 24.|
1764287|NCT00098748|3238907|Superiority or Other||difference in proportions|0.06|||||2-Sided|95.0|-0.1|0.21|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.|
1764288|NCT00098748|3238907|Superiority or Other||difference in proportions|-0.04|||||2-Sided|95.0|-0.18|0.1|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.|
1764289|NCT00098748|3238907|Superiority or Other||difference in proportions|0.11|||||2-Sided|95.0|-0.03|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO difference in proportions at Week 24.|
1764290|NCT00098748|3238907|Superiority or Other||difference in proportions|0.07|||||2-Sided|95.0|-0.07|0.2|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.|
1764291|NCT00098748|3238908|Superiority or Other||difference in proportions|0.12|||||2-Sided|95.0|-0.04|0.29|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.|
1764292|NCT00098748|3238908|Superiority or Other||difference in proportions|-0.02|||||2-Sided|95.0|-0.18|0.13|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.|
1764293|NCT00098748|3238908|Superiority or Other||difference in proportions|0.08|||||2-Sided|95.0|-0.1|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.|
1764294|NCT00098748|3238908|Superiority or Other||difference in proportions|-0.05|||||2-Sided|95.0|-0.21|0.12|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.|
1764295|NCT00098748|3238909|Superiority or Other||difference in proportions|0.11|||||2-Sided|95.0|-0.07|0.28|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.|
1764296|NCT00098748|3238909|Superiority or Other||difference in proportions|-0.06|||||2-Sided|95.0|-0.22|0.1|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.|
1764297|NCT00098748|3238909|Superiority or Other||difference in proportions|0.08|||||2-Sided|95.0|-0.1|0.26|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.|
1764298|NCT00098748|3238909|Superiority or Other||difference in proportions|0.03|||||2-Sided|95.0|-0.15|0.2|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.|
1764299|NCT00098748|3238910|Superiority or Other||difference in proportions|0.09|||||2-Sided|95.0|-0.07|0.25|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 48.|
1764300|NCT00098748|3238910|Superiority or Other||difference in proportions|0.02|||||2-Sided|95.0|-0.12|0.17|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 48.|
1764301|NCT00098748|3238910|Superiority or Other||difference in proportions|0.07|||||2-Sided|95.0|-0.08|0.23|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC BID vs PBO treatment difference in proportions at Week 24.|
1764302|NCT00098748|3238910|Superiority or Other||difference in proportions|0.03|||||2-Sided|95.0|-0.12|0.18|||||The TX difference is weighted (by inverse of the variance) difference in proportions adjusted for randomization strata. Positive values for TX difference favor MVC. CI estimated using the normal approximation to the binomial distribution.|MVC QD vs PBO treatment difference in proportions at Week 24.|
1764303|NCT00098748|3238911|Superiority or Other||Least squares mean|-0.261|Standard Error of the Mean|0.2628|||2-Sided|97.5|-0.856|0.333|||||Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 48.|
1764304|NCT00098748|3238911|Superiority or Other||Least squares mean|0.229|Standard Error of the Mean|0.2567|||2-Sided|97.5|-0.351|0.81|||||Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC QD vs PBO treatment difference at Week 48.|
1764305|NCT00098748|3238911|Superiority or Other||Least squares mean|-0.232|Standard Error of the Mean|0.2637|||2-Sided|97.5|-0.829|0.364|||||Negative values for change from baseline=benefit of TX; negative values for MVC vs PBO=advantage of MVC.|MVC BID vs PBO treatment difference at Week 24.|
1764306|NCT00098748|3238911|Non-Inferiority or Equivalence|For hypothesis of superiority, if upper bound of 97.5% confidence interval (CI) of TX difference was <0 log10 copies/mL, it was concluded that MVC regimen was superior to PBO meaning that MVC added to Optimized Background Therapy (OBT) provides an additional reduction in plasma HIV-1 RNA compared to OBT alone. If superiority could not be concluded, then a hypothesis of noninferiority was tested. If upper bound of CI is <0.25 log10 copies/mL, noninferiority of MVC regimen to placebo was claimed.|Least squares mean|0.055|Standard Error of the Mean|0.2575|||2-Sided|97.5|-0.528|0.638|||||Negative values for change from baseline=benefit of TX; negative values for MVC versus (vs) PBO=advantage of MVC.|Maraviroc (MVC) QD versus placebo (PBO) treatment (TX) difference at Week 24. If upper bound of 97.5% confidence interval is <0, it is concluded that dose is superior to PBO. If upper bound is <0.25, it is concluded that MVC is non-inferior to PBO. Assumption: 79% of subjects are dual-tropic; total N=192 needed to be randomized to get N=150 dual-tropic. Standard deviation=0.8 with 2-sided p-value=0.025: 80% power for TX difference of 0.5 for change from baseline in log10-transformed viral load.|
1764307|NCT00098722|3238918|Superiority or Other||LS mean difference|-1.033|Standard Error of the Mean|0.1685|||2-Sided|95.0|-1.364|-0.701||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.|
1764308|NCT00098722|3238918|Superiority or Other||LS mean difference|-0.855|Standard Error of the Mean|0.17|||2-Sided|95.0|-1.189|-0.521||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.|
1764309|NCT00098722|3238918|Superiority or Other||LS mean difference|-0.882|Standard Error of the Mean|0.1521|||2-Sided|95.0|-1.181|-0.584||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.|
1764310|NCT00098722|3238918|Superiority or Other||LS mean difference|-0.876|Standard Error of the Mean|0.1534|||2-Sided|95.0|-1.177|-0.575||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.|
1764311|NCT00098722|3238919|Superiority or Other||Hazard Ratio (HR)|0.33|||<|0.0001|2-Sided|95.0|0.23|0.46|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio <1 favors maraviroc.|
1764312|NCT00098722|3238919|Superiority or Other||Hazard Ratio (HR)|0.4|||<|0.0001|2-Sided|95.0|0.29|0.56|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio <1 favors maraviroc.|
1764313|NCT00098722|3238920|Superiority or Other||LS mean difference|140.25|Standard Error of the Mean|57.55|||2-Sided|95.0|27.15|253.35||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764314|NCT00098722|3238920|Superiority or Other||LS mean difference|136.93|Standard Error of the Mean|57.85|||2-Sided|95.0|23.24|250.62||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764315|NCT00098722|3238920|Superiority or Other||LS mean difference|133.22|Standard Error of the Mean|70.855|||2-Sided|95.0|-6.03|272.47||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764316|NCT00098722|3238920|Superiority or Other||LS mean difference|218.57|Standard Error of the Mean|71.225|||2-Sided|95.0|78.59|358.54||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764317|NCT00098722|3238921|Superiority or Other||LS mean difference|58.46|Standard Error of the Mean|14.725|||2-Sided|95.0|29.53|87.4||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764318|NCT00098722|3238921|Superiority or Other||LS mean difference|52.15|Standard Error of the Mean|14.803|||2-Sided|95.0|23.06|81.25||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764319|NCT00098722|3238921|Superiority or Other||LS mean difference|38.12|Standard Error of the Mean|13.313|||2-Sided|95.0|11.96|64.28||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764320|NCT00098722|3238921|Superiority or Other||LS mean difference|47.94|Standard Error of the Mean|13.383|||2-Sided|95.0|21.64|74.25||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764321|NCT00098722|3238923|Superiority or Other||Odds Ratio (OR)|4.1|||<|0.0001|2-Sided|95.0|2.2|7.64|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764322|NCT00098722|3238923|Superiority or Other||Odds Ratio (OR)|4.23|||<|0.0001|2-Sided|95.0|2.26|7.92|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764323|NCT00098722|3238923|Superiority or Other||Odds Ratio (OR)|2.88|||<|0.0005|2-Sided|95.0|1.59|5.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odd ratio >1 favors maraviroc.|
1764324|NCT00098722|3238923|Superiority or Other||Odds Ratio (OR)|3.55|||<|0.0001|2-Sided|95.0|1.95|6.48|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764325|NCT00098722|3238924|Superiority or Other||Odds Ratio (OR)|5.08|||<|0.0001|2-Sided|95.0|2.91|8.89|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764326|NCT00098722|3238924|Superiority or Other||Odds Ratio (OR)|4.01|||<|0.0001|2-Sided|95.0|2.29|7.0|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764327|NCT00098722|3238924|Superiority or Other||Odds Ratio (OR)|5.42|||<|0.0001|2-Sided|95.0|3.13|9.39|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764328|NCT00098722|3238924|Superiority or Other||Odds Ratio (OR)|4.58|||<|0.0001|2-Sided|95.0|2.64|7.92|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764329|NCT00098722|3238925|Superiority or Other||Odds Ratio (OR)|4.64|||<|0.0001|2-Sided|95.0|2.69|8.02|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764330|NCT00098722|3238925|Superiority or Other||Odds Ratio (OR)|3.67|||<|0.0001|2-Sided|95.0|2.13|6.32|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764331|NCT00098722|3238925|Superiority or Other||Odds Ratio (OR)|5.01|||<|0.0001|2-Sided|95.0|2.91|8.62|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764332|NCT00098722|3238925|Superiority or Other||Odds Ratio (OR)|4.69|||<|0.0001|2-Sided|95.0|2.72|8.1|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764333|NCT00098722|3238926|Superiority or Other||Odds Ratio (OR)|4.41|||<|0.0001|2-Sided|95.0|2.47|7.85|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764334|NCT00098722|3238926|Superiority or Other||Odds Ratio (OR)|4.03|||<|0.0001|2-Sided|95.0|2.25|7.2|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764335|NCT00098722|3238926|Superiority or Other||Odds Ratio (OR)|6.01|||<|0.0001|2-Sided|95.0|3.35|10.78|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764336|NCT00098722|3238926|Superiority or Other||Odds Ratio (OR)|4.59|||<|0.0001|2-Sided|95.0|2.56|8.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than [<] 100,000 or greater than or equal to [>=] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (>) 1 favors maraviroc.|
1764337|NCT00098722|3238927|Superiority or Other||LS mean difference|-1.109|Standard Error of the Mean|0.184|||2-Sided|97.5|-1.523|-0.695||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.|
1764338|NCT00098722|3238927|Superiority or Other||LS mean difference|-0.961|Standard Error of the Mean|0.1856|||2-Sided|97.5|-1.379|-0.544||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.|
1764339|NCT00098722|3238928|Superiority or Other||LS mean difference|-1.042|Standard Error of the Mean|0.1786|||2-Sided|97.5|-1.444|-0.64||||||The difference between the treatment LS means adjusted for randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.|
1764340|NCT00098722|3238928|Superiority or Other||LS mean difference|-1.021|Standard Error of the Mean|0.1802|||2-Sided|97.5|-1.426|-0.616||||||The difference between the treatment least square means (LS means) adjusted for randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.|
1764341|NCT00098475|3238936|Non-Inferiority or Equivalence (legacy)|The low-dose response would be considered unacceptable if the difference in response rates was 15% or greater (the upper confidence limit exceeds the 15% acceptable difference) regardless of a decrease in toxicity rate.|Difference in response rate between arms|0.107|||||2-Sided|80.0|0.052|0.162||||||The study was designed to determine if a reduced dose of dexamethasone in combination with CC-5013 reduced toxicity rate without reducing response rate. The standard-dose response was expected to be 70%. The low dose would be deemed unacceptable if the difference in response rate between arms was >=15%. The null hypothesis was that response rates were equal and the alternative was that the low-dose response was no worse than 55%. The design had a 1-sided 0.10 type I error rate and 95% power.|
1764342|NCT00098306|3238965|Superiority or Other||LS mean difference|-1.021|Standard Error of the Mean|0.1618|||2-Sided|97.5|-1.385|-0.658||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.|
1764343|NCT00098306|3238965|Superiority or Other||LS mean difference|-0.853|Standard Error of the Mean|0.1621|||2-Sided|97.5|-1.217|-0.489||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.|
1764344|NCT00098306|3238966|Superiority or Other||LS mean difference|-0.931|Standard Error of the Mean|0.1494|||2-Sided|95.0|-1.225|-0.638||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.|
1764345|NCT00098306|3238966|Superiority or Other||LS mean difference|-0.767|Standard Error of the Mean|0.1497|||2-Sided|95.0|-1.061|-0.474||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.|
1764346|NCT00098306|3238966|Superiority or Other||LS mean difference|-0.802|Standard Error of the Mean|0.1344|||2-Sided|95.0|-1.065|-0.538||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.|
1764347|NCT00098306|3238966|Superiority or Other||LS mean difference|-0.697|Standard Error of the Mean|0.1347|||2-Sided|95.0|-0.961|-0.432||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.|
1764348|NCT00098306|3238967|Superiority or Other||Hazard Ratio (HR)|0.38|||<|0.0001|2-Sided|95.0|0.28|0.5|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio <1 favors maraviroc.|
1764424|NCT00097591|3239050|Superiority or Other||Hazard Ratio (HR)|0.767|||<|0.001|2-Sided|95.0|0.672|0.876|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 30 days|
1764349|NCT00098306|3238967|Superiority or Other||Hazard Ratio (HR)|0.45|||<|0.0001|2-Sided|95.0|0.34|0.6|||Log Rank|||P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio <1 favors maraviroc.|
1764350|NCT00098306|3238968|Superiority or Other||LS mean difference|235.74|Standard Error of the Mean|49.416|||2-Sided|95.0|138.68|332.8||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764351|NCT00098306|3238968|Superiority or Other||LS mean difference|213.34|Standard Error of the Mean|49.679|||2-Sided|95.0|115.77|310.92||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764352|NCT00098306|3238968|Superiority or Other||LS mean difference|303.07|Standard Error of the Mean|51.507|||2-Sided|95.0|201.9|404.23||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764353|NCT00098306|3238968|Superiority or Other||LS mean difference|284.21|Standard Error of the Mean|51.779|||2-Sided|95.0|182.51|385.92||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764354|NCT00098306|3238969|Superiority or Other||LS mean difference|68.47|Standard Error of the Mean|12.617|||2-Sided|95.0|43.69|93.25||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764355|NCT00098306|3238969|Superiority or Other||LS mean difference|58.56|Standard Error of the Mean|12.677|||2-Sided|95.0|33.66|83.46||||||Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764356|NCT00098306|3238969|Superiority or Other||LS mean difference|58.94|Standard Error of the Mean|12.378|||2-Sided|95.0|34.63|83.26||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764357|NCT00098306|3238969|Superiority or Other||LS mean difference|54.49|Standard Error of the Mean|12.435|||2-Sided|95.0|30.07|78.92||||||Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.|
1764358|NCT00098306|3238971|Superiority or Other||Odds Ratio (OR)|4.97|||<|0.0001|2-Sided|95.0|2.82|8.77|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764359|NCT00098306|3238971|Superiority or Other||Odds Ratio (OR)|4.1|||<|0.0001|2-Sided|95.0|2.32|7.25|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764360|NCT00098306|3238971|Superiority or Other||Odds Ratio (OR)|3.15|||<|0.0001|2-Sided|95.0|1.9|5.23|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764361|NCT00098306|3238971|Superiority or Other||Odds Ratio (OR)|2.43|||<|0.0006|2-Sided|95.0|1.46|4.04|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764362|NCT00098306|3238972|Superiority or Other||Odds Ratio (OR)|4.03|||<|0.0001|2-Sided|95.0|2.5|6.51|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764363|NCT00098306|3238972|Superiority or Other||Odds Ratio (OR)|3.3|||<|0.0001|2-Sided|95.0|2.05|5.31|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764364|NCT00098306|3238972|Superiority or Other||Odds Ratio (OR)|3.55|||<|0.0001|2-Sided|95.0|2.22|5.68|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764365|NCT00098306|3238972|Superiority or Other||Odds Ratio (OR)|3.06|||<|0.0001|2-Sided|95.0|1.92|4.88|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764366|NCT00098306|3238973|Superiority or Other||Odds Ratio (OR)|3.33|||<|0.0001|2-Sided|95.0|2.08|5.32|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764425|NCT00097591|3239051|Superiority or Other||Hazard Ratio (HR)|0.794|||<|0.001|2-Sided|95.0|0.703|0.896|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 90 days|
1764367|NCT00098306|3238973|Superiority or Other||Odds Ratio (OR)|2.93|||<|0.0001|2-Sided|95.0|1.83|4.67|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764368|NCT00098306|3238973|Superiority or Other||Odds Ratio (OR)|2.85|||<|0.0001|2-Sided|95.0|1.79|4.54|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764369|NCT00098306|3238973|Superiority or Other||Odds Ratio (OR)|2.6|||<|0.0001|2-Sided|95.0|1.63|4.13|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764370|NCT00098306|3238974|Superiority or Other||Odds Ratio (OR)|5.11|||<|0.0001|2-Sided|95.0|3.04|8.59|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764371|NCT00098306|3238974|Superiority or Other||Odds Ratio (OR)|3.96|||<|0.0001|2-Sided|95.0|2.36|6.64|||Regression, Logistic|||Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764372|NCT00098306|3238974|Superiority or Other||Odds Ratio (OR)|3.66|||<|0.0001|2-Sided|95.0|2.26|5.95|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio >1 favors maraviroc.|
1764373|NCT00098306|3238974|Superiority or Other||Odds Ratio (OR)|2.88|||<|0.0001|2-Sided|95.0|1.78|4.67|||Regression, Logistic|||Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than [<] 100,000 or greater than or equal to [>=] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (>) 1 favors maraviroc.|
1764374|NCT00098306|3238975|Superiority or Other||LS mean difference|-0.922|Standard Error of the Mean|0.1568|||2-Sided|97.5|-1.275|-0.57||||||The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.|
1764375|NCT00098306|3238975|Superiority or Other||LS mean difference|-0.788|Standard Error of the Mean|0.1571|||2-Sided|97.5|-1.141|-0.435||||||The difference between the treatment least square means (LS means) adjusted for the randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.|
1764376|NCT00098293|3238977|Superiority or Other||Difference in Percentage|-3.9|||||1-Sided|97.5|-11.5|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|
1764377|NCT00098293|3238977|Superiority or Other||Difference in Percentage|-0.4|||||1-Sided|97.5|-7.9|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|
1764378|NCT00098293|3238978|Superiority or Other||Difference in Percentage|-0.2|||||1-Sided|97.5|-7.4|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|
1764379|NCT00098293|3238978|Superiority or Other||Difference in Percentage|0.6|||||1-Sided|97.5|-6.4|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.|
1764380|NCT00098293|3238979|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was > -10%.|Difference in Percentage|-5.8|||||1-Sided|97.5|-12.8|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|
1764381|NCT00098293|3238979|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (>) -10%.|Difference in Percentage|-3.2|||||1-Sided|97.5|-10.2|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|
1764426|NCT00097591|3239051|Superiority or Other||Hazard Ratio (HR)|0.784|||<|0.001|2-Sided|95.0|0.688|0.894|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 30 days|
1764493|NCT00095498|3239353|Superiority or Other||Mean Difference (Final Values)|2.04|||<|0.001||95.0|1.13|2.96|||Repeated Measures Model||||
1764382|NCT00098293|3238986|Superiority or Other||Hazard Ratio (HR)|1.1||||0.4811|2-Sided|95.0|0.86|1.4|||Log Rank|||Week 96: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio < 1 would favor maraviroc.|
1764383|NCT00098293|3238986|Superiority or Other||Hazard Ratio (HR)|1.1||||0.5874|2-Sided|95.0|0.83|1.45|||Log Rank|||Week 48: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio < 1 would favor maraviroc.|
1764384|NCT00098293|3238987|Superiority or Other||LS Mean Difference|172.22|Standard Error of the Mean|25.471|<|0.0001|2-Sided|95.0|122.21|222.23|||ANCOVA|||Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.|
1764385|NCT00098293|3238987|Superiority or Other||LS Mean Difference|166.29|Standard Error of the Mean|25.04|<|0.0001|2-Sided|95.0|117.13|215.46|||ANCOVA|||Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.|
1764386|NCT00098293|3238988|Superiority or Other||LS Mean Difference|35.44|Standard Error of the Mean|11.419||0.002|2-Sided|95.0|13.02|57.86|||ANCOVA|||Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.|
1764387|NCT00098293|3238988|Superiority or Other||LS Mean Difference|26.34|Standard Error of the Mean|9.827||0.0075|2-Sided|95.0|7.04|45.63|||ANCOVA|||Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.|
1764388|NCT00098293|3238989|Superiority or Other||LS Mean Difference|0.089|Standard Error of the Mean|0.1121||0.427|2-Sided|95.0|-0.131|0.309|||ANCOVA|||Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.|
1764389|NCT00098293|3238989|Superiority or Other||LS Mean Difference|0.111|Standard Error of the Mean|0.1002||0.2693|2-Sided|95.0|-0.086|0.307|||ANCOVA|||Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.|
1764390|NCT00098293|3238990|Superiority or Other||LS Mean Difference|0.1|Standard Error of the Mean|0.1162||0.3899|2-Sided|95.0|-0.128|0.328|||ANCOVA|||Change at week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.|
1764391|NCT00098293|3238990|Superiority or Other||LS Mean Difference|0.118|Standard Error of the Mean|0.1077||0.2741|2-Sided|95.0|-0.094|0.329|||ANCOVA|||Change at week 48: P-value was calculated using Analysis of Covariance (ANCOVA) with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment least squares means (LS means) adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.|
1764392|NCT00098293|3238991|Superiority or Other||Odds Ratio (OR)|0.79||||0.1289|2-Sided|95.0|0.59|1.07|||Regression, Logistic|||Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio > 1 would favor maraviroc.|
1764393|NCT00098293|3238991|Superiority or Other||Odds Ratio (OR)|0.88||||0.3943|2-Sided|95.0|0.65|1.19|||Regression, Logistic|||Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio > 1 would favor maraviroc.|
1764394|NCT00098293|3238992|Superiority or Other||Odds Ratio (OR)|0.84||||0.2724|2-Sided|95.0|0.61|1.15|||Regression, Logistic|||Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio > 1 would favor maraviroc.|
1764395|NCT00098293|3238992|Superiority or Other||Odds Ratio (OR)|0.88||||0.4485|2-Sided|95.0|0.64|1.22|||Regression, Logistic|||Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (<100,000 or >=100,000), geographic region (Northern or Southern Hemisphere) as covariates was used. Odds ratio > 1 would favor maraviroc.|
1764396|NCT00098293|3238993|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was > -10%.|Difference in Percentage|-4.4|||||1-Sided|97.5|-11.2|||||||Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|
1764397|NCT00098293|3238993|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was > -10%.|Difference in Percentage|-4.1|||||1-Sided|97.5|-10.5|||||||Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|
1764398|NCT00098293|3238994|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was > -10%.|Difference in Percentage|-4.2|||||1-Sided|97.5|-10.9|||||||Less than 50 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|
1764399|NCT00098293|3238994|Non-Inferiority or Equivalence|Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (>) -10%.|Difference in Percentage|-3.0|||||1-Sided|97.5|-9.5|||||||Less than 400 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% confidence interval (CI) based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.|
1764400|NCT00098254|3239001|Superiority or Other|||||||0.028|||||||Kaplan-Meier||||
1764401|NCT00098254|3239002|Superiority or Other|||||||0.042|||||||Kaplan-Meier||||
1764402|NCT00098254|3239003|Superiority or Other|||||||0.33|||||||Kaplan-Meier||||
1764403|NCT00098254|3239005|Superiority or Other|||||||0.0027|||||||Kaplan-Meier||||
1764404|NCT00097981|3239025|Superiority or Other||Hazard Ratio (HR)|0.975||||0.93|2-Sided|95.0|0.529|1.797|||Log Rank|Stratified log-rank test|||
1764405|NCT00097981|3239026|Superiority or Other|||||||0.5162|||||||Log Rank||||
1764406|NCT00097981|3239027|Superiority or Other|||||||0.42|||||||Log Rank||||
1764407|NCT00097981|3239028|Superiority or Other|||||||0.42|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Index (IPI) stage 1,2 and 3|||
1764408|NCT00097981|3239029|Superiority or Other|||||||0.49|||||||Cochran-Mantel-Haenszel|Stratified by International Prognostic Index (IPI) stage 1,2 and 3|||
1764409|NCT00097773|3239036|Superiority or Other||Hazard Ratio (HR)|1.29||||0.12|2-Sided|95.0|0.94|1.78|||Regression, Cox||Hazard ratio comparing cipro to placebo.|This analysis was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.|
1764410|NCT00097773|3239036|Superiority or Other||Hazard Ratio (HR)|0.8||||0.18|2-Sided|95.0|0.58|1.11|||Regression, Cox|No interaction with ciprofloxacin usage was observed.|Hazard ratio comparing cycled to culture based therapy|The analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation.|
1764411|NCT00097773|3239037|Superiority or Other||Odds Ratio (OR)|1.1||||0.67|2-Sided|95.0|0.71|1.71|||Regression, Logistic||odds of a positive culture comparing the cipro group to the placebo group|Null hypothesis is that there is no difference between pooled cipro and placebo treatment groups in the odds of a Pa positive culture over the 18 month study.|
1764412|NCT00097773|3239037|Superiority or Other||Odds Ratio (OR)|0.78||||0.28||95.0|0.49|1.23|||Regression, Logistic|No interaction with ciprofloxacin usage was observed.|odds of a positive culture comparing cycled therapy to culture-based therapy|Null hypothesis is that there is no difference between pooled cycled and culture-based treatment groups in the odds of a Pa positive culture over the 18 month study.|
1764413|NCT00097773|3239038|Superiority or Other||Hazard Ratio (HR)|1.45||||0.2|2-Sided|95.0|0.82|2.54|||Regression, Cox||risk of exacerbation comparing oral cipro to oral placebo|A secondary comparison was between the pooled oral cipro (n=152)and pooled placebo groups (n=152. Null hypothesis was no difference between groups.|
1764414|NCT00097773|3239038|Superiority or Other||Hazard Ratio (HR)|0.95||||0.86|2-Sided|95.0|0.54|1.66||There was no significant interaction with ciprofloxacin in this analysis.|Regression, Cox||risk of exacerbation comparing cycled therapy to culture-based therapy|The primary analysis compared the pooled Cycled Therapy group (n=152) vs. the Pooled culture-based therapy group (n=152). The null hypothesis was no difference between groups in the risk of pulmonary exacerbation requiring IV antibiotics or hospitalization. Assuming a total sample size of 300 (150 per group), the study provided 80% power to detect at least a 40% reduction in the risk of exacerbation in the cycled group as compared to the culture-based group at the two-sided alpha level of 5%.|
1764415|NCT00097708|3239044|Superiority or Other||Mean Difference (Net)|2.8||||0.0015|2-Sided|95.0|1.1|4.5|||ANCOVA||||
1764416|NCT00097708|3239044|Superiority or Other||Mean Difference (Net)|-3.2||||0.0005|2-Sided|95.0|-5.0|-1.4|||ANCOVA||||
1764417|NCT00097708|3239044|Superiority or Other||Mean Difference (Net)|-0.4||||0.654|2-Sided|95.0|-2.2|1.4|||ANCOVA||||
1764418|NCT00097695|3239045|Superiority or Other||||||=|0|||||||Wilcoxon version of the log-rank test|The median time to almost complete symptom relief was calculated using Kaplan-Meier methodology.The Wilcoxon version of the log-rank test of SAS used.|||
1764419|NCT00097695|3239046|Superiority or Other||||||<|0.001|||||||Wilcoxon version of the log-rank test|The median time to onset is calculated using Kaplan-Meier methodology. The Wilcoxon version of the log-rank test of SAS is used.|||
1764420|NCT00097695|3239047|Superiority or Other|||||||0.142|||||||Wilcoxon version of the log-rank test|The Wilcoxon version of the log-rank test of SAS was used to calculate statistical significance between p- vs icatibant group and placebo group.|||
1764421|NCT00097591|3239048|Superiority or Other||Hazard Ratio (HR)|0.831|||<|0.001|2-Sided|95.0|0.751|0.919|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.|||
1764422|NCT00097591|3239049|Superiority or Other||Hazard Ratio (HR)|0.838|||<|0.001|2-Sided|95.0|0.762|0.921|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.|||
1764423|NCT00097591|3239050|Superiority or Other||Hazard Ratio (HR)|0.797|||<|0.001|2-Sided|95.0|0.705|0.901|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||Through 90 days|
1764427|NCT00097591|3239052|Superiority or Other||Hazard Ratio (HR)|1.313||||0.022|2-Sided|95.0|1.04|1.656|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Minor Bleeding|
1764428|NCT00097591|3239052|Superiority or Other||Hazard Ratio (HR)|1.499||||0.084|2-Sided|95.0|0.945|2.379|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring transfusion (>=4 units)|
1764429|NCT00097591|3239052|Superiority or Other||Hazard Ratio (HR)|0.998||||0.995|2-Sided|95.0|0.528|1.885|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring surgical intervention|
1764430|NCT00097591|3239052|Superiority or Other||Hazard Ratio (HR)|2.617||||0.016|2-Sided|95.0|1.159|5.908|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Requiring inotropes|
1764431|NCT00097591|3239052|Superiority or Other||Hazard Ratio (HR)|1.119||||0.736|2-Sided|95.0|0.582|2.152|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Symptomatic intracranial hemorrage (ICH)|
1764432|NCT00097591|3239052|Superiority or Other||Hazard Ratio (HR)|4.191||||0.002|2-Sided|95.0|1.158|11.113|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - LT - Fatal|
1764433|NCT00097591|3239052|Superiority or Other||Hazard Ratio (HR)|1.517||||0.015|2-Sided|95.0|1.083|2.126|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For the subset of non-CABG TIMI Major Bleeding - Life-threatening events (LT)|
1764434|NCT00097591|3239052|Superiority or Other||Hazard Ratio (HR)|1.315||||0.029|2-Sided|95.0|1.028|1.683|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For non-CABG TIMI Major Bleeding|
1764435|NCT00097591|3239052|Superiority or Other||Hazard Ratio (HR)|1.314||||0.002|2-Sided|95.0|1.107|1.559|||Log Rank|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For non-CABG TIMI Major or Minor Bleeding|
1764436|NCT00097591|3239053|Superiority or Other||Hazard Ratio (HR)|0.812|||<|0.001|2-Sided|95.0|0.732|0.902|||Gehan-Wilcoxon|Clinical presentation, UA/NSTEMI versus STEMI, was used as a stratification factor.||For All ACS population|
1764437|NCT00097591|3239053|Superiority or Other||Hazard Ratio (HR)|0.793|||<|0.019|2-Sided|95.0|0.649|0.968|||Gehan-Wilcoxon|||For STEMI population|
1764438|NCT00097591|3239053|Superiority or Other||Hazard Ratio (HR)|0.82|||<|0.002|2-Sided|95.0|0.726|0.927||The primary outcome measure was analyzed first in the UA/NSTEMI population, followed by All ACS subjects, followed by the STEMI population.|Gehan-Wilcoxon|||For UA/NSTEMI population|
1764439|NCT00097500|3239060|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1764440|NCT00097500|3239062|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1764441|NCT00097500|3239063|Superiority or Other|||||||0.5522|||||||ANCOVA||||
1764442|NCT00097500|3239064|Superiority or Other|||||||0.1996|||||||ANCOVA|||Statistical analysis at week 56.|
1764443|NCT00097500|3239064|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Statistical analysis at week 52.|
1764444|NCT00097500|3239065|Superiority or Other|||||||0.1188|||||||ANCOVA|||Statistical analysis at week 56.|
1764445|NCT00097500|3239065|Superiority or Other||||||<|0.0001|||||||ANCOVA|||Statistical analysis at week 52.|
1764446|NCT00097500|3239066|Superiority or Other|||||||0.4185|||||||ANCOVA||||
1764447|NCT00097500|3239067|Superiority or Other|||||||0.0001|||||||ANCOVA||||
1764448|NCT00097253|3239083|Superiority or Other|||||||0.014|||||||Regression, Linear|||The maximum DTH wheal of days 1-3 (24, 48, or 72 h) was used as the dependent variable for each subject at each visit. Visits for subjects with a maximum DTH wheal of 5mm or less were excluded. A repeated measures linear model was used to evaluate odor and placebo effects.|
1764449|NCT00097253|3239084|Superiority or Other|||||||0.6|||||||Mixed Models Analysis|||Repeated-measures mixed effects models were used. Model was fit to the log-transformed data. Analysis applied to odor category, e.g. lavender / lemon / water.|
1764450|NCT00097253|3239085|Superiority or Other|||||||0.5|||||||Mixed Models Analysis|||IL-10. Mixed effect linear models were used to test the hypothesis. These models included the post-odor and post-stress dependent variable measurements with a covariate for the baseline pre-odor measurement. Base 10 logarithms were used for each dependent variable and baseline covariate.|
1764451|NCT00097253|3239085|Superiority or Other|||||||0.1|||||||Mixed Models Analysis|||IL-6. Mixed effect linear models were used to test the hypothesis. These models included the post-odor and post-stress dependent variable measurements with a covariate for the baseline pre-odor measurement. Base 10 logarithms were used for each dependent variable and baseline covariate.|
1764452|NCT00097253|3239086|Superiority or Other|||||||0.017|||||||Mixed Models Analysis|||Norepinephrine. Model controlled for Time 1 baseline. Comparing timepoints 4 and 5 for pre versus post stressor, e.g. lemon versus water control; Citrus(5-4)-Water(5-4).|
1764453|NCT00097253|3239086|Superiority or Other|||||||0.16|||||||Mixed Models Analysis|||Epinephrine. Analyses consisted of repeated-measures linear models fit to each dependent variable.IVs assessed in each model were odor, time, gender, expectancy group (primed vs. blind), their interactions;baseline level of the DV was included as a covariate. Post hoc tests were used as appropriate. A two-sided significance level of alpha = 0.05 was used. Model controlled for Time 1 baseline.|
1764454|NCT00097253|3239086|Superiority or Other|||||||0.83|||||||Regression, Linear|||Cortisol. Analyses consisted of repeated-measures linear models fit to each dependent variable.IVs assessed in each model were odor, time, gender, expectancy group (primed vs. blind), their interactions;baseline level of the DV was included as a covariate. Post hoc tests were used as appropriate. A two-sided significance level of alpha = 0.05 was used. Model controlled for Time 1 baseline.|
1764455|NCT00096460|3239112|Superiority or Other||Kaplan-Meier Survival Probability|85.7||||||95.0|63.3|100.0|||||||
1764456|NCT00096460|3239112|Superiority or Other||Kaplan-Meier Survival Probability|62.7|||||2-Sided|95.0|43.8|89.6|||||||
1764480|NCT00095498|3239346|Superiority or Other||||||<|0.001|||||||van Elteren Stratified Rank Test||||
1764481|NCT00095498|3239347|Superiority or Other||||||<|0.001|||||||van Elteren Stratified Rank Test||||
1764457|NCT00096356|3239122|Superiority or Other||Mean Difference (Final Values)|-0.68|Standard Error of the Mean|1.31||0.6014|2-Sided|95.0|-3.25|1.88||0.05 significance level, unadjusted for multiple comparisons|Mixed Models Analysis||This is the difference between treatment groups at 24 weeks (Co-Q10 minus Placebo). Lower is better for this outcome.|Constrained repeated measures analysis of variance, constrained such that the baseline means are equal, unadjusted of other covariates|
1764458|NCT00096356|3239123|Superiority or Other||Mean Difference (Final Values)|1.99|Standard Error of the Mean|2.31||0.3903|2-Sided|95.0|-2.56|6.53||0.05 significance level; no multiple comparison adjustment|Mixed Models Analysis||This is the difference in treatment groups at 24 weeks (Co-Q10 minus Placebo). Higher is better for this outcome.|Constrained repeated measures analysis of variance - constrained to have equal means at baseline, unadjusted for other covariates|
1764459|NCT00096356|3239124|Superiority or Other||Mean Difference (Final Values)|-1.37|Standard Error of the Mean|1.03||0.1815|2-Sided|95.0|-3.39|0.64||The a priori significance level was 0.05 for the primary outcome; there is no adjustment for multiple comparisons.|Mixed Models Analysis||This is the estimate of the difference in arms (Co-Q10 minus placebo). Lower is better for this outcome.|Constrained repeated measures analysis of variance - constrained such that baseline fatigue was the same in both groups and unadjusted for any baseline covariates.|
1764460|NCT00096265|3239134|Superiority|||||||0.8|||||||Chi-squared|||A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.|
1764461|NCT00096265|3239134|Superiority|||||||0.78|||||||Chi-squared|||A two group chi-square test with a 0.05 two-sided significance level would have 89% power to detect the difference between a proportion of 0.50 and a proportion of 0.30, or equivalently, of 0.70, when the sample size in each group is 120.|
1764462|NCT00096265|3239135|Superiority|||||||0.56|||||||Chi-squared|||Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/[2(π2j-π1j)], of 0.1217.|
1764463|NCT00096265|3239135|Superiority|Assuming the survival rate of the standard arm (MST = 5.9 months), then 49% of patients were expected to be alive at six months. Assuming steroid data would be available for 90% of these patients, results in a projection of 52 cases/arm with steroid data at 6 months. With this sample size, a two-sided 0.050 alpha test will have 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/[2(π2j-π1j)], of 0.1217.||||||0.51|||||||Chi-squared||||
1764464|NCT00096265|3239136|Superiority||||||<|0.001|||||||Chi-squared|||108 cases with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/[2(π2j-π1j)], of 0.0586.|
1764465|NCT00096265|3239136|Superiority||||||<|0.002|||||||Chi-squared|||108 with three month performance status data, per arm, would result in a 0.050 level chi-square test with 90% power to distinguish between the groups when the proportions in the 3 categories are characterized by an effect size, Δ² = Σ(π2j-π1j)2/[2(π2j-π1j)], of 0.0586.|
1764466|NCT00096265|3239137|Superiority|||||||0.28|||||||Chi-squared|||With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/[2(π2j-π1j)], of 0.0702.|
1764467|NCT00096265|3239137|Superiority|||||||0.39|||||||Chi-squared|||With 70 patients per arm, a 0.05 level chi-square test would have 80% power to distinguish between two groups when the proportions in the three categories are as follows for standard vs. experimental arm, respectively: 25% vs. 50% improvement, 55% vs. 40% stable, and 20% vs. 10% deterioration, or any distribution that corresponds to an effect size, Δ² = Σ(π2j-π1j)2/[2(π2j-π1j)], of 0.0702.|
1764468|NCT00096265|3239139|Superiority|||||||0.48|||||||Gray's test||||
1764469|NCT00096265|3239139|Superiority|||||||0.3|||||||Gray's test||||
1764470|NCT00096265|3239140|Superiority or Other||Hazard Ratio (HR)|1.47||||0.95|2-Sided|95.0|0.92|2.36||One-sided|Log Rank||WBRT + SRS is the denominator of the hazard ratio.|120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.|
1764471|NCT00096265|3239140|Superiority or Other||Hazard Ratio (HR)|1.43||||0.93|2-Sided|95.0|0.89|2.31||One-sided|Log Rank||WBRT + SRS is the denominator of the hazard ratio.|120 patients per arm required to detect a 33% reduction in hazard rate corresponding to improvement in MST of 5.9 (null hypothesis) to 8.9 months with a one-sided type I error rate of 0.025 and 85% power.|
1764472|NCT00095784|3239193|Superiority or Other (legacy)|||||||0.99|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in hemoglobin F levels.|
1764473|NCT00095784|3239199|Superiority or Other (legacy)|||||||0.29|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in CXCR4 levels. Analysis performed on log scale.|
1764474|NCT00095784|3239205|Superiority or Other (legacy)||||||<|0.0001|||||||Mixed Models Analysis|5 degrees of freedom test over six time points: day 1 (pre-treatment) and days 5, 12, 43, 47, and 54 post treatment.||Mixed effects regression analysis of change over time in CD34+ cell levels. Analysis performed on log scale.|
1764475|NCT00095498|3239344|Superiority or Other|||||||0.133|||||||van Elteren Stratified Rank Test||||
1764476|NCT00095498|3239344|Superiority or Other|||||||0.175|||||||van Elteren Stratified Rank Test||||
1764477|NCT00095498|3239345|Superiority or Other|||||||0.589|||||||van Elteren Stratified Rank Test||||
1764478|NCT00095498|3239345|Superiority or Other|||||||0.673|||||||van Elteren Stratified Rank Test||||
1764479|NCT00095498|3239346|Superiority or Other||||||<|0.001|||||||van Elteren Stratified Rank Test||||
1764494|NCT00095498|3239353|Superiority or Other||Mean Difference (Final Values)|1.94|||<|0.001||95.0|1.02|2.85|||Repeated Measures Model||||
1764495|NCT00095498|3239354|Superiority or Other||Mean Difference (Final Values)|1.18|||<|0.001||95.0|0.51|1.85|||Repeated Measures Model||||
1764496|NCT00095498|3239354|Superiority or Other||Mean Difference (Final Values)|1.0|||<|0.004||95.0|0.33|1.67|||Repeated Measures Model||||
1764497|NCT00095498|3239355|Superiority or Other||Mean Difference (Final Values)|0.08||||0.787||95.0|-0.53|0.69|||Repeated Measures Model||||
1764498|NCT00095498|3239355|Superiority or Other||Mean Difference (Final Values)|0.02||||0.938||95.0|-0.58|0.63|||Repeated Measures Model||||
1764499|NCT00095498|3239356|Superiority or Other||Mean Difference (Final Values)|1.98||||0.003||95.0|0.67|3.29|||Repeated Measures Model||||
1764500|NCT00095498|3239356|Superiority or Other||Mean Difference (Final Values)|1.81||||0.007||95.0|0.51|3.12|||Repeated Measures Model||||
1764501|NCT00095498|3239357|Superiority or Other||Mean Difference (Final Values)|0.89||||0.09||95.0|-0.14|1.93|||Repeated Measures Model||||
1764502|NCT00095498|3239357|Superiority or Other||Mean Difference (Final Values)|0.95||||0.073||95.0|-0.09|1.99|||Repeated Measures Model||||
1764503|NCT00095498|3239358|Superiority or Other||Mean Difference (Final Values)|0.8||||0.141||95.0|-0.27|1.86|||Repeated Measures Model||||
1764504|NCT00095498|3239358|Superiority or Other||Mean Difference (Final Values)|0.01||||0.986||95.0|-1.06|1.08|||Repeated Measures Model||||
1764505|NCT00095498|3239359|Superiority or Other||Mean Difference (Final Values)|3.29|||<|0.001||95.0|2.18|4.39|||Repeated Measures Model||||
1764506|NCT00095498|3239359|Superiority or Other||Mean Difference (Final Values)|2.2|||<|0.001||95.0|1.1|3.29|||Repeated Measures Model||||
1764507|NCT00095498|3239360|Superiority or Other||Mean Difference (Final Values)|1.89|||<|0.001||95.0|0.84|2.94|||Repeated Measures Model||||
1764508|NCT00095498|3239360|Superiority or Other||Mean Difference (Final Values)|1.67|||<|0.002||95.0|0.62|2.72|||Repeated Measures Model||||
1764509|NCT00095498|3239361|Superiority or Other||Mean Difference (Final Values)|0.59||||0.155||95.0|-0.23|1.41|||Repeated measures model||||
1764510|NCT00095498|3239361|Superiority or Other||Mean Difference (Final Values)|0.93||||0.026||95.0|0.11|1.74|||Repeated Measures Model||||
1764511|NCT00095498|3239362|Superiority or Other|||||||0.712|||||||van Elteren Stratified Rank Test||||
1764512|NCT00095498|3239362|Superiority or Other|||||||0.236|||||||van Elteren Stratified Rank Test||||
1764513|NCT00095498|3239363|Superiority or Other|||||||0.488|||||||van Elteren Stratified Rank Test||||
1764514|NCT00095498|3239363|Superiority or Other|||||||0.382|||||||van Elteren Stratified Rank Test||||
1764515|NCT00095498|3239364|Superiority or Other|||||||0.019|||||||van Elteren Stratified Rank Test||||
1764516|NCT00095498|3239364|Superiority or Other|||||||0.277|||||||van Elteren Stratified Rank Test||||
1764517|NCT00095498|3239365|Superiority or Other|||||||0.007|||||||van Elteren Stratified Rank Test||||
1764518|NCT00095498|3239365|Superiority or Other|||||||0.012|||||||van Elteren Stratified Rank Test||||
1764519|NCT00095498|3239366|Superiority or Other|||||||0.181|||||||van Elteren Stratified Rank Test||||
1764520|NCT00095498|3239366|Superiority or Other|||||||0.602|||||||van Elteren Stratified Rank Test||||
1764521|NCT00095498|3239367|Superiority or Other|||||||0.18|||||||van Elteren Stratified Rank Test||||
1764522|NCT00095498|3239367|Superiority or Other|||||||0.032|||||||van Elteren Stratified Rank Test||||
1764523|NCT00095498|3239368|Superiority or Other|||||||0.018|||||||van Elteren stratified rank test||||
1764524|NCT00095498|3239368|Superiority or Other|||||||0.264|||||||van Elteren stratified rank test||||
1764525|NCT00095303|3239369|Superiority or Other||Mean Difference (Net)|0.14||||0.23|2-Sided|95.0|-0.09|0.37|||GEE||||
1764526|NCT00095303|3239373|Superiority or Other||Slope|0.33||||0.12|2-Sided|95.0|-0.09|0.76|||GEE||The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.|Null hypothesis: BSFT will be significantly more effective than TAU in decreasing sexually risky behaviors. The total score of the ‘HIV/Sex Risk Behaviors’ measure will be used as the outcome.Hypothesis analyzed using the hierarchical linear model.|
1764527|NCT00095303|3239374|Superiority or Other||Mean Difference (Net)|0.68||||0.12|2-Sided|95.0|-0.18|1.54|||GEE||||
1764528|NCT00095303|3239378|Superiority or Other||Slope|0.12||||0.015|2-Sided|95.0|0.03|0.22|||Mixed Models Analysis|||Null hypothesis: BSFT will be significantly more effective than TAU in improving family functioning.The four components of the ‘Parenting Practices Inventory’ will be used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are ‘Positive Parenting’, ‘Discipline Effectiveness,’ ‘Avoidance of Discipline’ and ‘Monitoring’ scales from the Pittsburgh Youth Survey. Hypothesis will be analyzed as using hierarchical linear models.|
1764529|NCT00095303|3239379|Superiority or Other||Mean Difference (Final Values)|-0.42|||<|0.006|2-Sided|95.0|-0.71|-0.12|||GEE|||Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in the level of externalizing problem behaviors|
1764530|NCT00095303|3239381|Superiority or Other||Rate Ratio|0.94||||0.21|2-Sided|95.0|0.82|1.09|||GEE|||Null Hypothesis: BSFT will be significantly more effective than TAU in the rates of drug use, defined as the percentage of drug use days in last 90 days. The primary hypothesis will be evaluated in terms of % of days of drug use in the last 90 days, assessed by the timeline follow-back. The general analytic approach will use generalized estimating equation (GEE) with negative binomial distribution comparing the BSFT and TAU participants|
1764531|NCT00095303|3239397|Superiority or Other||Slope|-0.1||||0.26|2-Sided|95.0|-0.28|0.08|||Mixed Models Analysis||The parameter estimated is the regression coefficient on the interaction of BSFT treatment assignment and the linear time trend.|Null hypothesis: It is hypothesized that BSFT will be significantly more effective than TAU in decreasing adolescent externalizing problem behaviors|
1764589|NCT00094809|3239676|Superiority or Other||Odds Ratio (OR)|0.27||||0.0384||95.0|0.07|1.0|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of pegfilgrastim group compared to placebo group||
1764857|NCT00090857|3240068|Superiority or Other|||||||0.49|||||||Fisher Exact||||
1764532|NCT00095303|3239399|Superiority or Other||slope of linear trajectory of drug use|0.05||||0.27|2-Sided|95.0|-0.04|0.14|||Mixed Models Analysis||The parameter estimated is the regression coefficient on the interaction of the BSFT treatment assignment and the linear time trend.|Null Hypothesis: BSFT will be significantly more effective than TAU in reducing adolescent drug abuse, defined as the percentage of drug use days in 28-day periods. The outcome variable is the percentage of days of drug use within a 28-day period. This variable constructed from the Timeline-Follow-back instrument and measured as the sum of the number of days with positive use in 28-day increments. Hypothesis tested using hierarchical linear models.|
1764533|NCT00095238|3239416|Superiority or Other||Mean Difference (Final Values)|0.6|||||2-Sided|95.0|-0.5|1.7||||||comparison of 2 treatment arms at Month 14 (columns 3 and 4)|
1764534|NCT00095238|3239416|Superiority or Other||Mean Difference (Final Values)|0.2|||||2-Sided|95.0|-0.8|1.3||||||Comparison of 2 treatment arms at Month 6 (first 2 columns)|
1764535|NCT00095212|3239419|Superiority or Other|||||||0.94|||||||t-test, 2 sided||||
1764536|NCT00095212|3239420|Superiority or Other|||||||0.22|||||||t-test, 2 sided||||
1764537|NCT00095212|3239421|Superiority or Other|||||||0.26|||||||t-test, 2 sided||||
1764538|NCT00095212|3239422|Superiority or Other|||||||0.14|||||||Chi-squared||||
1764539|NCT00095212|3239423|Superiority or Other|||||||0.75|||||||Chi-squared||||
1764540|NCT00095212|3239424|Superiority or Other|||||||0.29|||||||Chi-squared||||
1764541|NCT00095212|3239425|Superiority or Other|||||||0.16|||||||Chi-squared||||
1764542|NCT00095212|3239426|Superiority or Other|||||||0.01|||||||Longitudinal mixed methods model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.|
1764543|NCT00095212|3239427|Superiority or Other|||||||0.02|||||||Longitudinal mixed methods model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.|
1764544|NCT00095212|3239428|Superiority or Other|||||||0.02|||||||Longitudinal linear mixed effects model|||The study was powered at 80% to detect a significant treatment difference of 2.7 kg in lean body mass between the two groups with 25 randomized patients and a 15% assumed dropout rate, using a two sided 5.0 percent significance level.|
1764545|NCT00095212|3239429|Superiority or Other|||||||0.04|||||||longitudinal linear mixed effects model||||
1764546|NCT00095199|3239431|Superiority or Other||Hazard Ratio (HR)|0.96||||0.887|2-Sided|95.0|0.42|2.18||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|The Kaplan-Meier method estimated duration of response. HR was calculated using unstratified Cox proportional hazards model. HR<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764547|NCT00095199|3239431|Superiority or Other||Hazard Ratio (HR)|1.58||||0.236|2-Sided|95.0|0.74|3.36||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|The Kaplan-Meier method estimated duration of response. HR was calculated using unstratified Cox proportional hazards model. HR<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764548|NCT00095199|3239432|Superiority or Other||Hazard Ratio (HR)|0.73||||0.272|2-Sided|95.0|0.42|1.27||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier estimated time to symptomatic progression. HR was calculated using unstratified Cox proportional hazards model. HR<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764549|NCT00095199|3239432|Superiority or Other||Hazard Ratio (HR)|1.16||||0.472|2-Sided|95.0|0.77|1.74||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier estimated time to symptomatic progression. HR was calculated using unstratified Cox proportional hazards model. HR<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764550|NCT00095199|3239433|Superiority or Other||Odds Ratio (OR)|1.34||||0.361|2-Sided|95.0|0.72|2.5||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764551|NCT00095199|3239433|Superiority or Other||Odds Ratio (OR)|0.7||||0.091|2-Sided|95.0|0.46|1.06||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764566|NCT00095147|3239518|Superiority or Other||Difference from placebo|-0.3|||<|0.001|2-Sided|95.0|-0.45|-0.15|||ANCOVA|||Adjusted mean change in HAQ-DI from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.|
1764552|NCT00095199|3239434|Superiority or Other||Odds Ratio (OR)|1.49||||0.1|2-Sided|95.0|0.93|2.4||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764553|NCT00095199|3239434|Superiority or Other||Odds Ratio (OR)|1.18||||0.31|2-Sided|95.0|0.86|1.62||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764554|NCT00095199|3239435|Superiority or Other||Odds Ratio (OR)|1.19||||0.683|2-Sided|95.0|0.52|2.74||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764555|NCT00095199|3239435|Superiority or Other||Odds Ratio (OR)|1.59||||0.2|2-Sided|95.0|0.78|3.26||The 2-sided unstratified Mantel Haenszel test was employed at the 5% significance level.|Mantel Haenszel|HR<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764556|NCT00095199|3239436|Superiority or Other||Hazard Ratio (HR)|1.13||||0.307|2-Sided|95.0|0.9|1.41||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median OS time. HR was calculated with unstratified Cox proportional hazards model. HR<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764557|NCT00095199|3239436|Superiority or Other||Hazard Ratio (HR)|1.01||||0.864|2-Sided|95.0|0.86|1.2||The 2-sided unstratified log-rank test was employed at the 5% significance level|Log Rank|Kaplan-Meier method estimated median OS time. HR was calculated with unstratified Cox proportional hazards model. HR<1 favors Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764558|NCT00095199|3239437|Superiority or Other||Hazard Ratio (HR)|0.91||||0.391|2-Sided|95.0|0.73|1.13||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median PFS time. HR was calculated with unstratified Cox proportional hazards model. HR<1 favours Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764559|NCT00095199|3239437|Superiority or Other||Hazard Ratio (HR)|1.03||||0.756|2-Sided|95.0|0.87|1.21||The 2-sided unstratified log-rank test was employed at the 5% significance level.|Log Rank|Kaplan-Meier method estimated median PFS time. HR was calculated with unstratified Cox proportional hazards model. HR<1 favours Cetuximab arm||The Pemetrexed comparisons (Cetuximab + Pemetrexed vs Pemetrexed) were considered the primary comparisons. The Docetaxel comparisons (Cetuximab + Docetaxel vs Docetaxel) were considered supportive as Docetaxel comparisons remained underpowered by design. No tests were conducted to compare participants who received Docetaxel to those who received Pemetrexed.|
1764560|NCT00095173|3239451|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1764561|NCT00095173|3239452|Superiority or Other||Hazard Ratio (HR)|0.31||||0.0002|2-Sided|95.0|0.16|0.59|||Log Rank||Abatacept over placebo||
1764562|NCT00095147|3239516|Superiority or Other||Difference from placebo (MCS)|2.68||||0.027|2-Sided|95.0|0.31|5.05|||ANCOVA|||Adjusted mean change in SF-36 mental component summary from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.|
1764563|NCT00095147|3239516|Superiority or Other||Difference from placebo (PCS)|3.32||||0.002|2-Sided|95.0|1.25|5.4|||ANCOVA|||Adjusted mean change in SF-36 physical component summary from baseline to 6 months (Day 197) was compared between INF and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.|
1764564|NCT00095147|3239516|Superiority or Other||Difference from placebo (MCS)|3.51||||0.004|2-Sided|95.0|1.1|5.91|||ANCOVA|||Adjusted mean change in SF-36 mental component summary from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.|
1764565|NCT00095147|3239516|Superiority or Other||Difference from placebo (PCS)|4.02|||<|0.001|2-Sided|95.0|1.92|6.12|||ANCOVA|||Adjusted mean change in SF-36 physical component summary from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.|
1764567|NCT00095147|3239518|Superiority or Other||Difference from placebo|-0.38|||<|0.001|2-Sided|95.0|-0.53|-0.23|||ANCOVA|||Adjusted mean change in HAQ-DI from baseline to 6 months (Day 197) was compared between ABA and PLA. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.|
1764568|NCT00095147|3239520|Superiority or Other||Estimate of difference from placebo|17.9||||0.005|2-Sided|95.0|5.1|30.7|||Chi-squared, Corrected|||Comparisons were made between INF and PLA at Day 197 using a continuity corrected Chi-square test. All tests and confidence intervals for treatment comparison were two-sided.|
1764569|NCT00095147|3239520|Superiority or Other||Estimate of difference from placebo|20.6||||0.001|2-Sided|95.0|7.7|33.6|||Chi-squared, Corrected|||Comparisons were made between ABA and PLA at Day 197 using a continuity corrected Chi-square test. All tests and confidence intervals for treatment comparison were two-sided.|
1764570|NCT00095147|3239522|Superiority or Other||adjusted mean change from baseline|-0.77|||<|0.001|2-Sided|95.0|-1.14|-0.39|||ANCOVA|||Infliximab versus placebo were compared for changes from baseline to 6 months (Day 197) in the DAS28. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.|
1764571|NCT00095147|3239523|Superiority or Other||adjusted mean change from baseline|-1.04|||<|0.001|2-Sided|95.0|-1.42|-0.67|||ANCOVA|||The primary analysis was the comparison of abatacept versus placebo for changes from baseline to 6 months (Day 197) in the DAS28. This comparison was done using an analysis of covariance (ANCOVA) model with treatment group as the effect and baseline value as the covariate. A 95% confidence interval was computed for the treatment difference within the framework of the ANCOVA model.|
1764572|NCT00095121|3239529|Superiority or Other|||||||0.051||||||Comparison of HBeAg Seroconversion|Fisher Exact||||
1764573|NCT00095121|3239529|Superiority or Other|||||||0.051||||||Comparison of HBeAg Loss|Fisher Exact||||
1764574|NCT00095121|3239545|Superiority or Other||||||<|0.001||||||End of double-blind treatment|Fisher Exact|||After unblinding the results, due to the small number of responders in the placebo group, it was determined that a statistical exact test would be more appropriate in the evaluation of treatment group differences than the originally planned 95% confidence intervals of the difference between the groups. Therefore, the results were analyzed by study visit, and a Fisher exact test was used to evaluate treatment differences between the adefovir dipivoxil and placebo groups.|
1764575|NCT00094887|3239650|Other||||||=|0|||||||Wilcoxon (Mann-Whitney)||||
1764576|NCT00094861|3239651|Superiority or Other||Chi-Square Statistic|3.1414||||0.1996||||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.|||
1764577|NCT00094861|3239652|Superiority or Other||Chi-Square Statistic|0.0294||||0.8639||95.0||||Generalized Cochran-Mantel-Haenszel test for general association.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.|||
1764578|NCT00094861|3239653|Superiority or Other||Chi-Square Statistic|3.4812||||0.0621|2-Sided|||||Generalized Cochran-Mantel-Haenszel (CMH) test for mean score difference using modified ridit score. Participants without any ECOG assessment post baseline were assumed to have ECOG status of 5 in the CMH test.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.|||
1764579|NCT00094861|3239654|Superiority or Other||Chi-Square Statistic|-2.5325||||0.1115||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants who never received radiotherapy were assumed to have unplanned breaks.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.|||
1764580|NCT00094861|3239655|Superiority or Other||Chi-Square Statistic|0.46||||0.4976||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade ≥ 3 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.|||
1764581|NCT00094861|3239656|Superiority or Other||Chi-Square Statistic|0.437||||0.5086||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade 5 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.|||
1764582|NCT00094861|3239657|Superiority or Other||Chi-Square Statistic|0.9936||||0.3189||95.0||||Generalized Cochran-Mantel-Haenszel test for mean score difference using modified ridit score.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.|||
1764583|NCT00094861|3239658|Superiority or Other||Chi-Square Statistic|0.8553||||0.355||95.0||||Generalized Cochran-Mantel-Haenszel test for general association. Participants with no assessments were assumed as having grade ≥ 2 dysphagia in hypothesis testing.|Cochran-Mantel-Haenszel|Stratified by disease stage, ECOG performance status, and estimated weight loss in the 3 months before study randomization.|||
1764584|NCT00094809|3239670|Superiority or Other||Odds Ratio (OR)|0.71||||0.3792||95.0|0.32|1.53|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of the pegfilgrastim group compared to the placebo group||
1764585|NCT00094809|3239671|Superiority or Other||Odds Ratio (OR)|0.23||||0.0457||95.0|0.05|1.09|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio for pegfilgrastim group compared to placebo group||
1764586|NCT00094809|3239672|Superiority or Other||Treatment difference|-12.1||||||95.0|-28.1|4.0|||||Kaplan-Meier estimates of the difference in percent mortality for the pegfilgrastim group - placebo group. Median survival time was not reached for the pegfilgrastim group.||
1764587|NCT00094809|3239673|Superiority or Other||Treatment difference|-3.5||||0.5434||95.0|-14.8|7.8|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference (pegfilgrastim group - placebo group) in the percentage of participants with a complete or partial response||
1764588|NCT00094809|3239675|Superiority or Other||Odds Ratio (OR)|0.73||||0.5514||95.0|0.26|2.04|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio for pegfilgrastim group compared to placebo group||
1764590|NCT00094809|3239677|Superiority or Other||Treatment difference|-12.0||||0.0646||95.0|-23.7|0.5|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference in percentage of participants (pegfilgrastim group - placebo group)||
1764591|NCT00094809|3239678|Superiority or Other||Treatment difference|-18.0|||<|0.0001||95.0|-26.2|-9.8|||Mantel Haenszel|Adjusted for chemotherapy regimen|Treatment difference in percentage of participants (pegfilgrastim group - placebo group)||
1764592|NCT00094809|3239679|Superiority or Other||Odds Ratio (OR)|0.19|||<|0.0001||95.0|0.1|0.37|||Mantel Haenszel|Adjusted for chemotherapy regimen|Common odds ratio of the pegfilgrastim group compared to the placebo group||
1764593|NCT00094757|3239694|Superiority or Other||Mean Difference (Net)|-16.9|Standard Deviation|45.9|<|0.002|2-Sided|95.0|-27.6|-6.1|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status|||
1764594|NCT00094757|3239694|Superiority or Other||Mean Difference (Net)|-19.7|Standard Deviation|45.9|<|0.001|2-Sided|95.0|-30.5|-8.9|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status|||
1764595|NCT00094757|3239695|Superiority or Other||Mean Difference (Net)|-0.48|Standard Deviation|0.9|<|0.001|2-Sided|95.0|-0.7|-0.26|||ANCOVA|Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)|||
1764596|NCT00094757|3239695|Superiority or Other||Mean Difference (Net)|-0.6|Standard Deviation|0.9|<|0.001|2-Sided|95.0|-0.82|-0.39||Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)|ANCOVA||||
1764597|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-3.1||||0.2849|2-Sided|95.0|-8.8|2.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline|
1764598|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|1.4||||0.6949|2-Sided|95.0|-5.6|8.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline|
1764599|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.5717|2-Sided|95.0|-7.5|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Financial Impact change from baseline|
1764600|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-2.6||||0.4169|2-Sided|95.0|-9.0|3.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline|
1764601|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|6.9||||0.0821|2-Sided|95.0|-0.9|14.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline|
1764602|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|4.3||||0.194|2-Sided|95.0|-2.2|10.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Diarrhea change from baseline|
1764603|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|3.4||||0.2796|2-Sided|95.0|-2.8|9.5|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline|
1764604|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-9.9||||0.0101|2-Sided|95.0|-17.4|-2.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline|
1764605|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-6.5||||0.0431|2-Sided|95.0|-12.9|-0.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Constipation change from baseline|
1764606|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-3.1||||0.3911|2-Sided|95.0|-10.2|4.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite Loss change from baseline|
1764607|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|1.3||||0.7675|2-Sided|95.0|-7.4|10.1|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite Loss change from baseline|
1764608|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-1.8||||0.6291|2-Sided|95.0|-9.1|5.5|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Appetite loss change from baseline|
1764609|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-3.6||||0.3351|2-Sided|95.0|-10.9|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep Disturbance change from baseline|
1764858|NCT00090857|3240069|Superiority or Other|||||||0.58|||||||Fisher Exact||||
1764859|NCT00090857|3240070|Superiority or Other|||||||0.6|||||||Fisher Exact||||
1764610|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.8464|2-Sided|95.0|-10.0|8.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep disturbance change from baseline|
1764611|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-4.5||||0.245|2-Sided|95.0|-12.1|3.1|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Sleep disturbance change from baseline|
1764612|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-1.8||||0.5548|2-Sided|95.0|-7.9|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline|
1764613|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-3.8||||0.3187|2-Sided|95.0|-11.2|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline|
1764614|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-5.6||||0.0761|2-Sided|95.0|-11.8|0.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Dyspnea change from baseline|
1764615|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-2.3||||0.4898|2-Sided|95.0|-8.7|4.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline|
1764616|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-4.0||||0.3214|2-Sided|95.0|-11.9|3.9|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline|
1764617|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-6.3||||0.0625|2-Sided|95.0|-12.8|0.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Pain change from baseline|
1764618|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|1.4||||0.5497|2-Sided|95.0|-3.3|6.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline|
1764619|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-1.3||||0.6716|2-Sided|95.0|-7.1|4.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline|
1764620|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|0.2||||0.9397|2-Sided|95.0|-4.7|5.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Nausea and Vomiting change from baseline|
1764621|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.5329|2-Sided|95.0|-8.2|4.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline|
1764622|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.6168|2-Sided|95.0|-9.6|5.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline|
1764623|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-3.9||||0.2259|2-Sided|95.0|-10.3|2.4|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Fatigue change from baseline|
1764624|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|1.9||||0.5538|2-Sided|95.0|-4.5|8.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline|
1764625|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-3.4||||0.4041|2-Sided|95.0|-11.3|4.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline|
1764626|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-1.4||||0.6695|2-Sided|95.0|-8.1|5.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Social change from baseline|
1764627|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|2.0||||0.3938|2-Sided|95.0|-2.7|6.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline|
1764628|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-2.0||||0.4873|2-Sided|95.0|-7.8|3.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline|
1764629|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|0.0||||0.9984|2-Sided|95.0|-4.8|4.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Emotional change from baseline|
1764630|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|1.2||||0.6266|2-Sided|95.0|-3.6|6.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline|
1764631|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.7616|2-Sided|95.0|-6.9|5.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline|
1764632|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|0.3||||0.9119|2-Sided|95.0|-4.7|5.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Cognitive change from baseline|
1764633|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|1.1||||0.7597|2-Sided|95.0|-6.1|8.3|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline|
1764634|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|3.2||||0.4742|2-Sided|95.0|-5.6|12.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline|
1764635|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|4.3||||0.248|2-Sided|95.0|-3.0|11.7|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Role change, change from baseline|
1764636|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|-1.1||||0.659|2-Sided|95.0|-6.0|3.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline|
1764637|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|5.0||||0.0978|2-Sided|95.0|-0.9|11.0|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline|
1764638|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|3.9||||0.1219|2-Sided|95.0|-1.1|8.9|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Physical change from baseline|
1764639|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|1.4||||0.6026|2-Sided|95.0|-3.9|6.8|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline|
1764640|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|1.6||||0.63|2-Sided|95.0|-5.0|8.2|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline|
1764641|NCT00094653|3239702|Superiority or Other||Mean Difference (Final Values)|3.0||||0.2805|2-Sided|95.0|-2.5|8.6|||ANCOVA||Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.|Global quality of life change from baseline|
1764642|NCT00094653|3239704|Superiority or Other|||||||0.0429||||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel||||
1764643|NCT00094653|3239704|Superiority or Other|||||||0.0002||||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel||||
1764644|NCT00094653|3239704|Superiority or Other|||||||0.0179||||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel||||
1764645|NCT00094653|3239707|Superiority or Other|||||||0.0402||||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel||||
1764646|NCT00094653|3239707|Superiority or Other|||||||0.0012||||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel||||
1764647|NCT00094653|3239707|Superiority or Other|||||||0.0433||||||P-values were computed using CMH test stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior IL-2 treatment (Yes vs. No).|Cochran-Mantel-Haenszel||||
1764648|NCT00094653|3239709|Superiority or Other||Hazard Ratio (HR)|1.25|||||2-Sided|95.0|1.01|1.53|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).||
1764649|NCT00094653|3239709|Superiority or Other||Hazard Ratio (HR)|0.64|||||2-Sided|95.0|0.5|0.83|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).||
1764650|NCT00094653|3239709|Superiority or Other||Hazard Ratio (HR)|0.81|||||2-Sided|95.0|0.66|1.0|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).||
1764651|NCT00094653|3239711|Superiority or Other||Hazard Ratio (HR)|1.25|||||2-Sided|95.0|1.01|1.53|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).||
1764652|NCT00094653|3239711|Superiority or Other||Hazard Ratio (HR)|0.64|||||2-Sided|95.0|0.5|0.83|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).||
1764653|NCT00094653|3239711|Superiority or Other||Hazard Ratio (HR)|0.81|||||2-Sided|95.0|0.66|1.0|||||Cox model for Hazard ratios (HR) were stratified by M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).||
1764654|NCT00094653|3239713|Superiority or Other||Hazard Ratio (HR)|1.04||||0.7575|2-Sided|95.0|0.83|1.3|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).||
1764655|NCT00094653|3239713|Superiority or Other||Hazard Ratio (HR)|0.66||||0.0026|2-Sided|95.0|0.51|0.87|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).||
1764656|NCT00094653|3239714|Superiority or Other||Hazard Ratio (HR)|0.68||||0.0004|2-Sided|95.0|0.55|0.85|||Stratified Log Rank||Cox model for Hazard ratios (HR) and log-rank test p-values were stratified by baseline M-stage at randomization (M0, M1a, M1b vs. M1c) and prior treatment with IL-2 (Yes vs. No).||
1764657|NCT00094575|3239715|Superiority or Other|||||||0.68|||||||Mixed Models Analysis||||
1764658|NCT00094575|3239716|Superiority or Other|||||||0.37|||||||Mixed Models Analysis||||
1764659|NCT00094575|3239717|Superiority or Other|||||||0.58|||||||Mixed Models Analysis|||Note: Since this is measuring change over time since baseline, values could be below 0.|
1764660|NCT00094575|3239718|Superiority or Other|||||||0.78|||||||Mixed Models Analysis||||
1764661|NCT00094575|3239719|Superiority or Other|||||||0.8|||||||Mixed Models Analysis||||
1764662|NCT00094575|3239720|Superiority or Other|||||||0.81|||||||Mixed Models Analysis||||
1764663|NCT00094575|3239721|Superiority or Other|||||||0.12|||||||Chi-squared||||
1764664|NCT00094575|3239722|Superiority or Other||Hazard Ratio (HR)|0.97||||0.81|2-Sided|95.0|0.77|1.22|||Log Rank||The HR was estimated by comparing Endovascular repair arm vs the Open repair arm.|The primary outcome was long-term, all-cause mortality. The sample size would provide 80% power to detect a 25% relative reduction in mortality at a two-sided alpha level of 0.05. The primary comparison was the main effects of Endovascular repair vs Open repair of AAA.|
1764665|NCT00094536|3239723|Superiority or Other|||||||0.271|||||||1-sided z-test|1-sided z-test with continuity correction (pooled)|||
1764666|NCT00094458|3239739|Superiority or Other|||||||0.055|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn’s disease and corticosteroid treatment at Baseline|||
1764667|NCT00094458|3239739|Superiority or Other|||||||0.023|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn’s disease and corticosteroid treatment at Baseline|||
1764668|NCT00094458|3239739|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn’s disease and corticosteroid treatment at Baseline|||
1764669|NCT00094458|3239740|Superiority or Other|||||||0.022|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn’s disease and corticosteroid treatment at Baseline|||
1764670|NCT00094458|3239740|Superiority or Other|||||||0.006|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn’s disease and corticosteroid treatment at Baseline|||
1764671|NCT00094458|3239740|Superiority or Other||||||<|0.001|||||||Cochran-Mantel-Haenszel|The P-Value is from a CMH test stratified by duration of Crohn’s disease and corticosteroid treatment at Baseline|||
1764672|NCT00094328|3239748|Other|One sample t-test|Median Difference (Final Values)|-0.07||||0.882|2-Sided|95.0|-1.15|1.0|||t-test, 2 sided|||The primary efficacy parameter, change in growth rate (SD units) after 12 months relative to the baseline growth rate was analysed using a one sample t-test. A 95% 2-sided confidence interval was calculated for the mean change in growth rate.|
1764673|NCT00094328|3239749|Other|One sample t-test|Mean Difference (Final Values)|-1.62||||0.278|2-Sided|95.0|-4.72|1.48|||t-test, 2 sided|||The primary efficacy parameter, change in growth rate (cm/year) after 12 months relative to the baseline growth rate was analysed using a one sample t-test. A 95% 2-sided confidence interval was calculated for the mean change in growth rate.|
1764674|NCT00094302|3239750|Superiority or Other|||||||0.02|||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764675|NCT00094302|3239750|Superiority or Other|||||||0.98|||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764766|NCT00092495|3239946|Non-Inferiority or Equivalence|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764676|NCT00094302|3239751|Superiority or Other|||||||0.54|||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764677|NCT00094302|3239751|Superiority or Other|||||||0.59|||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764678|NCT00094302|3239752|Superiority or Other||||||<|0.01|||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764679|NCT00094302|3239752|Superiority or Other||||||<|0.11|||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764680|NCT00094302|3239753|Superiority or Other||||||<|0.01|||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764681|NCT00094302|3239753|Superiority or Other||||||<|0.53|||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764682|NCT00094302|3239754|Superiority or Other||||||<|0.01|||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764683|NCT00094302|3239754|Superiority or Other||||||<|0.27|||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764684|NCT00094302|3239755|Superiority or Other||Hazard Ratio (HR)|0.94||||0.25|2-Sided|95.0|0.85|1.04||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~There were a total of 1558 subjects (766 subjects in the Spironolactone group and 792 subjects in the Placebo) who were hospitalized for any cause while on study. This endpoint was not adjudicated by the TOPCAT clinical endpoints committee."|
1764685|NCT00094302|3239756|Superiority or Other|||||||0.01|||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764686|NCT00094302|3239756|Superiority or Other|||||||0.39|||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764687|NCT00094302|3239757|Superiority or Other|||||||0.99|||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score and treatment group as predictor variables. This tests whether the value of the post-baseline quality of life parameter differs by treatment group.|
1764688|NCT00094302|3239758|Superiority or Other|||||||0.16|||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764689|NCT00094302|3239758|Superiority or Other|||||||0.87|||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764737|NCT00092677|3239884|Superiority or Other||Hazard Ratio (HR)|1.088||||0.771||95.0|0.617|1.917|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764690|NCT00094302|3239759|Superiority or Other||||||<|0.01|||||||Regression, Linear|||Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764691|NCT00094302|3239759|Superiority or Other||||||<|0.27|||||||Regression, Linear|||A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.|
1764692|NCT00094302|3239760|Superiority or Other||Hazard Ratio (HR)|0.94||||0.75|2-Sided|95.0|0.66|1.35||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 61 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.|
1764693|NCT00094302|3239761|Superiority or Other||Hazard Ratio (HR)|1.49|||<|0.01|2-Sided|95.0|1.18|1.87||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~There were 295 subjects (175 in the Spironolactone group and 120 in the Placebo group) experiencing this endpoint. This endpoint did not undergo adjudication by the TOPCAT clinical endpoints committee."|
1764694|NCT00094302|3239762|Superiority or Other||Hazard Ratio (HR)|0.94||||0.73|2-Sided|95.0|0.65|1.35||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 117 subjects (57 in the Spironolactone group and 60 in the Placebo group) with confirmed events."|
1764695|NCT00094302|3239763|Superiority or Other||Hazard Ratio (HR)|1.0||||0.98|2-Sided|95.0|0.71|1.42||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 129 subjects (65 in the Spironolactone group and 64 in the Placebo group) with confirmed events."|
1764696|NCT00094302|3239764|Superiority or Other||Hazard Ratio, log|1.02||||0.94|2-Sided|95.0|0.69|1.5||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 103 subjects (52 in the Spironolactone group and 51 in the Placebo group) with confirmed events."|
1764697|NCT00094302|3239765|Superiority or Other||Hazard Ratio (HR)|1.08||||0.76|2-Sided|95.0|0.64|1.83||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 56 subjects (29 in the Spironolactone group and 27 in the Placebo group) with confirmed events."|
1764698|NCT00094302|3239766|Superiority or Other||Hazard Ratio (HR)|0.96||||0.82|2-Sided|95.0|0.67|1.38||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 60 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.|
1764699|NCT00094302|3239767|Superiority or Other||incidence rate ratio|0.75||||0.03|2-Sided|95.0|0.58|0.97||No covariate adjustment|Negative binomial regression||Spironolactone compared to Placebo|There were a total of 869 confirmed heart failure hospitalizations (394 in the Spironolactone group and 475 in the Placebo group) during the 11,471 person-years collected over the course of the TOPCAT trial (5,755 person-years in the Spironolactone group and 5,716 person-years in the Placebo group). The incidence rate of heart failure hospitalizations for each treatment group was compared using a negative binomial regression with a p-value threshold of 0.05 for statistical significance.|
1764700|NCT00094302|3239768|Superiority or Other||Hazard Ratio (HR)|0.89||||0.15|2-Sided|95.0|0.76|1.04||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 291 subjects in Spironolactone group and 320 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.|
1764738|NCT00092677|3239885|Superiority or Other||Hazard Ratio (HR)|0.997||||0.968||95.0|0.842|1.179|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764860|NCT00090857|3240071|Superiority or Other|||||||0.27|||||||Fisher Exact||||
1764861|NCT00090857|3240072|Superiority or Other|||||||0.88|||||||Fisher Exact||||
1764701|NCT00094302|3239769|Superiority or Other||Hazard Ratio (HR)|0.93||||0.28|2-Sided|95.0|0.8|1.06||No covariate adjustment|Log Rank|Two-sided log rank test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 382 subjects in Spironolactone group and 404 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.|
1764702|NCT00094302|3239770|Superiority or Other||Hazard Ratio (HR)|0.91||||0.29|2-Sided|95.0|0.77|1.08||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|Endpoint compared by trial arm using logrank test of time to event from randomization. Subjects who did not experience endpoint were censored at time of last contact. Attempts were made to determine vital status as of each subject’s last potential visit, based on randomization, even if the subject ended study participation before then. This outcome was adjudicated. There were 252 events over 6,022 patient-years in Spironolactone arm and 274 events over 5,981 patient-years in Placebo arm.|
1764703|NCT00094302|3239771|Superiority or Other||Hazard Ratio (HR)|0.83||||0.04|2-Sided|95.0|0.69|0.99||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 451 subjects (206 in the Spironolactone group and 245 in the Placebo group) who have been confirmed to have experienced the event"|
1764704|NCT00094302|3239772|Superiority or Other||Hazard Ratio (HR)|0.6||||0.48|2-Sided|95.0|0.14|2.5||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 8 subjects (3 in the Spironolactone group and 5 in the Placebo group) with a confirmed event."|
1764705|NCT00094302|3239773|Superiority or Other||Hazard Ratio (HR)|0.9||||0.35|2-Sided|95.0|0.73|1.12||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|"This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.~This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 336 subjects (160 in the Spironolactone group and 176 in the Placebo group) with a confirmed event."|
1764706|NCT00094302|3239774|Superiority or Other||Hazard Ratio (HR)|0.89||||0.14|2-Sided|95.0|0.77|1.04||No covariate adjustment|Log Rank|Two-sided log rand test (0.05 Type 1 error)|Spironolactone compared to Placebo|Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 320 subjects in the Spironolactone group and 351 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.|
1764707|NCT00094172|3239780|Superiority or Other|||||||0.526|||||||Log Rank||||
1764708|NCT00094172|3239781|Superiority or Other|||||||0.208|||||||Log Rank||||
1764709|NCT00094172|3239782|Superiority or Other|||||||0.823|||||||Fisher Exact|||This is the secondary analysis of the primary endpoint|
1764710|NCT00094172|3239782|Superiority or Other|||||||0.929|||||||Log Rank|||This is the primary analysis of the primary endpoint|
1764711|NCT00093470|3239844|Superiority or Other||Hazard Ratio (HR)|0.809||||0.056|2-Sided|95.0|0.567|1.155||one-sided p-value; threshold for statistical significance < 0.025|Log Rank|stratified log rank test|Hazard ratio of OS for Arm A to Arm B||
1764712|NCT00093470|3239845|Superiority or Other||Hazard Ratio (HR)|0.76||||0.026|2-Sided|95.0|0.538|1.072||one-sided p-value; threshold for statistical significance <0.025|Log Rank|stratified log rank test|Hazard ratio of DFS for Arm A to Arm B||
1764713|NCT00093015|3239860|Superiority or Other||Cox Proportional Hazard|0.84||||0.4||95.0|0.55|1.27||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)||
1764714|NCT00093015|3239861|Superiority or Other||Mean Difference (Final Values)|1.33|Standard Deviation|0.35|<|0.001||95.0|0.64|2.02||Nominal p-value is presented.|t-test, 2 sided||Difference (darbepoetin alfa - placebo)||
1764715|NCT00093015|3239862|Superiority or Other||Slope|-0.12||||0.54||95.0|-0.51|0.26||Nominal p-value is from the term treatment group*visit in the mixed model.|Mixed Models Analysis|Adjusted for baseline eGFR and the stratification factors of proteinuria and CVD history.|Estimated difference in rate of decline in eGFR per year between darbepoetin alfa and placebo.||
1764716|NCT00093015|3239863|Superiority or Other||Cox Proportional Hazard|1.02||||0.83||95.0|0.87|1.18||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)||
1764717|NCT00093015|3239864|Superiority or Other||Cox Proportional Hazard|0.89||||0.24||95.0|0.74|1.08||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)||
1764862|NCT00090857|3240073|Superiority or Other|||||||0.2|||||||Fisher Exact||||
1764863|NCT00090857|3240074|Superiority or Other|||||||0.02|||||||Fisher Exact||||
1764718|NCT00093015|3239865|Superiority or Other||Cox Proportional Hazard|1.92|||<|0.001||95.0|1.38|2.68||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)||
1764719|NCT00093015|3239866|Superiority or Other||Cox Proportional Hazard|0.96||||0.73||95.0|0.75|1.23||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)||
1764720|NCT00093015|3239867|Superiority or Other||Cox Proportional Hazard|1.05||||0.61||95.0|0.88|1.25||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)||
1764721|NCT00093015|3239868|Superiority or Other||Cox Proportional Hazard|1.05||||0.48||95.0|0.92|1.21||Nominal p-value from a 2-sided log rank test is presented.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)||
1764722|NCT00093015|3239869|Superiority or Other||Cox Proportional Hazard|1.06||||0.29||95.0|0.95|1.19||Nominal p-value from a 2-sided log rank test is presented. The primary renal composite endpoint was tested at the 0.002 significance level at final analysis.|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)||
1764723|NCT00093015|3239870|Superiority or Other||Cox Proportional Hazard|1.05||||0.41||95.0|0.94|1.17||Nominal p-value from a 2-sided log rank test is presented. The primary cardiovascular composite endpoint was tested at the 0.04056 significance level at final analysis after accounting for 4 planned interim analyses (overall alpha = 0.048).|Log Rank|A 2-sided log-rank test comparing the survival functions of the 2 groups stratified by baseline proteinuria and CV disease (CVD) history.|Treatment effect was estimated using a hazards ratio and 95% confidence interval (CI) obtained from a Cox proportional hazards model stratified by baseline proteinuria and CVD history. Hazard ratio (darbepoetin alfa / placebo)||
1764724|NCT00092677|3239871|Superiority or Other||Mean Difference (Final Values)|-20.0|Standard Error of the Mean|1.3|<=|0||95.0|-22.6|-17.3|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo||
1764725|NCT00092677|3239872|Superiority or Other||Mean Difference (Final Values)|3.9|Standard Error of the Mean|0.8|<=|0||95.0|2.4|5.5|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo||
1764726|NCT00092677|3239873|Superiority or Other||Mean Difference (Final Values)|-50.0|Standard Error of the Mean|0.9|<=|0||95.0|-51.8|-48.2|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo||
1764727|NCT00092677|3239874|Superiority or Other||Mean Difference (Final Values)|-32.1|Standard Error of the Mean|0.6|<=|0||95.0|-33.3|-31.0|||ANOVA|Model terms: treatment|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo||
1764728|NCT00092677|3239875|Superiority or Other||Mean Difference (Final Values)|-0.006|Standard Error of the Mean|0.029||0.829||95.0|-0.063|0.051|||ANCOVA|Model terms: treatment and baseline peak transaortic jet velocity|Direction of the Comparison: EZ/Simva 10/40 mg minus Placebo||
1764729|NCT00092677|3239876|Superiority or Other||Hazard Ratio (HR)|1.504||||0.008||95.0|1.111|2.035|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764730|NCT00092677|3239877|Superiority or Other||Hazard Ratio (HR)|1.667||||0.052||95.0|0.996|2.791|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764731|NCT00092677|3239878|Superiority or Other||Hazard Ratio (HR)|1.036||||0.799||95.0|0.788|1.363|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764732|NCT00092677|3239879|Superiority or Other||Hazard Ratio (HR)|1.124||||0.647||95.0|0.682|1.85|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764733|NCT00092677|3239880|Superiority or Other||Hazard Ratio (HR)|0.608||||||95.0|0.199|1.86|||||Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764734|NCT00092677|3239881|Superiority or Other||Hazard Ratio (HR)|0.456||||||95.0|0.197|1.057|||||Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764735|NCT00092677|3239882|Superiority or Other||Hazard Ratio (HR)|0.683||||0.015||95.0|0.503|0.929|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764736|NCT00092677|3239883|Superiority or Other||Hazard Ratio (HR)|0.636||||0.147||95.0|0.345|1.173|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764864|NCT00090857|3240075|Superiority or Other|||||||0.38|||||||Fisher Exact||||
1765902|NCT00070707|3241998|Superiority or Other|||||||0.994|||||||ANOVA|||Change at Week 1 (AM)|
1764739|NCT00092677|3239886|Superiority or Other||Hazard Ratio (HR)|0.829||||0.344||95.0|0.563|1.222|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764740|NCT00092677|3239887|Superiority or Other||Hazard Ratio (HR)|0.78||||0.024||95.0|0.628|0.967|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764741|NCT00092677|3239888|Superiority or Other||Hazard Ratio (HR)|0.973||||0.732||95.0|0.833|1.137|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764742|NCT00092677|3239889|Superiority or Other||Hazard Ratio (HR)|0.96||||0.591||95.0|0.826|1.115|||Regression, Cox|Model terms: treatment and baseline peak transaortic jet velocity (as continuous covariate)|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on EZ/Simva 10/40 mg compared to Placebo||
1764743|NCT00092534|3239935|Superiority or Other (legacy)||Percent relative risk reduction|96.6||||||95.0|88.2|99.6|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter||
1764744|NCT00092521|3239936|Superiority or Other||Percent relative risk reduction|100.0||||||95.0|94.9|100.0|||||CI based on binomial tail probabilities and not from a dispersion parameter||
1764745|NCT00092521|3239937|Superiority or Other||Percent relative risk reduction|100.0||||||95.0|95.1|100.0|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter||
1764746|NCT00092495|3239938|Non-Inferiority or Equivalence|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764747|NCT00092495|3239938|Non-Inferiority or Equivalence|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764748|NCT00092495|3239938|Non-Inferiority or Equivalence|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764749|NCT00092495|3239939|Non-Inferiority or Equivalence|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764750|NCT00092495|3239939|Non-Inferiority or Equivalence|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764751|NCT00092495|3239939|Non-Inferiority or Equivalence|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764752|NCT00092495|3239940|Non-Inferiority or Equivalence|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764753|NCT00092495|3239940|Non-Inferiority or Equivalence|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764754|NCT00092495|3239941|Non-Inferiority or Equivalence|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764755|NCT00092495|3239941|Non-Inferiority or Equivalence|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764756|NCT00092495|3239942|Non-Inferiority or Equivalence|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764757|NCT00092495|3239942|Non-Inferiority or Equivalence|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764758|NCT00092495|3239942|Non-Inferiority or Equivalence|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764759|NCT00092495|3239943|Non-Inferiority or Equivalence|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764760|NCT00092495|3239943|Non-Inferiority or Equivalence|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764761|NCT00092495|3239943|Non-Inferiority or Equivalence|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.01|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764762|NCT00092495|3239944|Non-Inferiority or Equivalence|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764763|NCT00092495|3239944|Non-Inferiority or Equivalence|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764764|NCT00092495|3239945|Non-Inferiority or Equivalence|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764765|NCT00092495|3239945|Non-Inferiority or Equivalence|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764767|NCT00092495|3239946|Non-Inferiority or Equivalence|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group|||
1764768|NCT00092495|3239946|Non-Inferiority or Equivalence|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764769|NCT00092495|3239947|Non-Inferiority or Equivalence|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764770|NCT00092495|3239947|Non-Inferiority or Equivalence|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764771|NCT00092495|3239947|Non-Inferiority or Equivalence|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764772|NCT00092495|3239948|Non-Inferiority or Equivalence|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group|||
1764773|NCT00092495|3239948|Non-Inferiority or Equivalence|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group|||
1764774|NCT00092495|3239949|Non-Inferiority or Equivalence|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764775|NCT00092495|3239949|Non-Inferiority or Equivalence|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764776|NCT00092495|3239950|Non-Inferiority or Equivalence|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764777|NCT00092495|3239950|Non-Inferiority or Equivalence|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764778|NCT00092495|3239950|Non-Inferiority or Equivalence|The ratio of GMTs (partial dose/full dose) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764779|NCT00092495|3239951|Non-Inferiority or Equivalence|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764780|NCT00092495|3239951|Non-Inferiority or Equivalence|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764781|NCT00092495|3239951|Non-Inferiority or Equivalence|The difference in seroconversion rates (partial dose - full dose) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764782|NCT00092495|3239952|Non-Inferiority or Equivalence|The ratio of GMTs (boys/women) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764783|NCT00092495|3239952|Non-Inferiority or Equivalence|The ratio of GMTs (girls/women) must be greater than 0.5.|||||<|0.001|||||||ANOVA|ANOVA on natural log titer with fixed effects for region and comparison group.|||
1764784|NCT00092495|3239953|Non-Inferiority or Equivalence|The difference in seroconversion rates (boys - women) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764785|NCT00092495|3239953|Non-Inferiority or Equivalence|The difference in seroconversion rates (girls - women) must be greater than -5%.|||||<|0.001|||||||Miettinen and Nurminen|"Miettinen and Nurminen method for difference in proportions~Miettinen and Nurminen, Stat Med 1985;4:213-26"|||
1764786|NCT00092456|3239963|Non-Inferiority or Equivalence|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).|||||<|0.001||||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANCOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.|
1764787|NCT00092456|3239963|Non-Inferiority or Equivalence|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2)|||||<|0.001||||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.|
1764818|NCT00091832|3240010|Superiority or Other||Hazard Ratio (HR)|1.09||||||95.0|0.68|1.74|||||A hazard ratio >1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.||
1764819|NCT00091832|3240010|Superiority or Other||Hazard Ratio (HR)|1.09||||||95.0|0.68|1.74|||||A hazard ratio >1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.||
1764788|NCT00092456|3239963|Non-Inferiority or Equivalence|If equivalence was established in all 3 pairwise comparisons for a given serotype, the 3 lots were considered consistent for that serotype. Each comparison consisted of 2 one-sided tests of equivalence with α=0.05. Statistical significance for the 2 one-sided equivalence tests for each pair of lots was established if the p-values for the hypothesis tests were each less than 0.05. This corresponds to the 2-sided 90% CI for the fold difference in the 2 lots being contained entirely within (0.5,2).|||||<|0.001||||||The reported p-value is for all 5 serotypes, no multiplicity adjustment made, and Type I error rate controlled at the 0.05 level. P<0.05 implies that the difference is statistically significantly less than the prespecified difference of 2 fold.|ANOVA|||A pairwise comparison of lots was made for each serotype, for each pair of lots.|
1764789|NCT00092443|3239964|Superiority or Other||Percent of Participants|2.9||||||95.0|0.4|10.1|||||||
1764790|NCT00092443|3239964|Superiority or Other||Percent of Participants|24.6||||||95.0|14.5|37.3|||||||
1764791|NCT00092443|3239964|Superiority or Other||Percent of Participants|1.4||||||95.0|0.0|7.7|||||||
1764792|NCT00092443|3239964|Superiority or Other||Percent of Participants|39.7||||||95.0|27.6|52.8|||||||
1764793|NCT00092443|3239964|Superiority or Other||Percent of Participants|0.0||||||95.0|0.0|4.8|||||||
1764794|NCT00092443|3239964|Superiority or Other||Percent of Participants|9.0||||||95.0|3.4|18.5|||||||
1764795|NCT00092443|3239964|Superiority or Other||Percent of Participants|0.0||||||95.0|0.0|5.1|||||||
1764796|NCT00092443|3239964|Superiority or Other||Percent of Participants|14.5||||||95.0|6.9|25.8|||||||
1764797|NCT00092443|3239964|Superiority or Other||Percent of Participants|2.7||||||95.0|0.3|9.5|||||||
1764798|NCT00092443|3239964|Superiority or Other||Percent of Participants|56.7||||||95.0|44.0|66.8|||||||
1764799|NCT00092443|3239965|Superiority or Other||Efficacy = 1-Relative Risk|72.5|||<|0.001||95.0|50.6|85.6|||Exact Binomial Test||Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.||
1764800|NCT00091962|3239988|Superiority or Other||Mean Difference (Final Values)|0.001||||0.001|2-Sided|95.0||||repeated measures mixed-effect model with treatment, time (4 time points), and sex; all 2- and 3-factor interaction terms with subject intercepts were treated as a random effect to account for individual differences at randomization.|Mixed Models Analysis||||
1764801|NCT00091949|3239990|Superiority or Other (legacy)||Hazard Ratio (HR)|0.82||||0.11|2-Sided|95.0|0.65|1.05||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).||
1764802|NCT00091949|3239991|Superiority or Other (legacy)||Mean Difference (Net)|-0.023||||0.88|2-Sided|95.0|-0.326|0.28|||Mixed Models Analysis||Pioglitazone arm compared to placebo.|Changes in modified mini-mental examination (3MS) score from baseline (to annual scores) were analyzed using a longitudinal repeated measures mixed effects model.|
1764803|NCT00091949|3239992|Superiority or Other (legacy)||Hazard Ratio (HR)|0.93||||0.52|2-Sided|95.0|0.73|1.17||p-value adjusted for multiplicity (5 secondary outcomes)|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).||
1764804|NCT00091949|3239994|Superiority or Other (legacy)||Hazard Ratio (HR)|0.75||||0.11|2-Sided|95.0|0.52|1.07||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for multiplicity (5 secondary outcomes).||
1764805|NCT00091949|3239995|Superiority or Other (legacy)||Hazard Ratio (HR)|0.82||||0.19|2-Sided|95.0|0.61|1.1||P-value adjusted for multiplicity (5 secondary outcomes).|Regression, Cox||Pioglitazone arm compared to placebo; conference interval (CI) adjusted for multiplicity (5 secondary outcomes).||
1764806|NCT00091949|3239996|Superiority or Other (legacy)||Hazard Ratio (HR)|0.76||||0.0067|2-Sided|95.0|0.62|0.93||P-value adjusted for interim looks.|Regression, Cox||Pioglitazone arm compared to placebo; CI adjusted for interim looks.||
1764807|NCT00091832|3239998|Superiority or Other||Odds Ratio (OR)|1.88||||||95.0|0.5|7.05|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764808|NCT00091832|3239998|Superiority or Other||Odds Ratio (OR)|1.88||||||95.0|0.5|7.05|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764809|NCT00091832|3239998|Superiority or Other||Odds Ratio (OR)|0.81||||||95.0|0.26|2.52|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764810|NCT00091832|3239998|Superiority or Other||Odds Ratio (OR)|1.2||||||95.0|0.36|3.97|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764811|NCT00091832|3239998|Superiority or Other||Odds Ratio (OR)|1.92||||||95.0|0.51|7.17|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764812|NCT00091832|3239999|Superiority or Other||Hazard Ratio (HR)|0.54||||||95.0|0.158|1.847|||||A hazard ratio <1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.||
1764813|NCT00091832|3239999|Superiority or Other||Hazard Ratio (HR)|1.073||||||95.0|0.389|2.963|||||A hazard ratio <1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.||
1764814|NCT00091832|3239999|Superiority or Other||Hazard Ratio (HR)|0.791||||||95.0|0.266|2.355|||||A hazard ratio <1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.||
1764815|NCT00091832|3239999|Superiority or Other||Hazard Ratio (HR)|0.544||||||95.0|0.159|1.859|||||A hazard ratio <1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.||
1764816|NCT00091832|3239999|Superiority or Other||Hazard Ratio (HR)|0.543||||||95.0|0.159|1.856|||||A hazard ratio <1 indicates the time to the first skeletal-related event in the denosumab-treated group was longer than that in the control group.||
1764817|NCT00091832|3240010|Superiority or Other||Hazard Ratio (HR)|1.14||||||95.0|0.71|1.83|||||A hazard ratio >1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.||
1764856|NCT00091026|3240057|Superiority or Other||Risk Difference (RD)|0.0||||0.22|2-Sided|95.0|-13.0|14.0|||Chi-squared||||
1764820|NCT00091832|3240010|Superiority or Other||Hazard Ratio (HR)|1.03||||||95.0|0.64|1.65|||||A hazard ratio >1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.||
1764821|NCT00091832|3240010|Superiority or Other||Hazard Ratio (HR)|0.82||||||95.0|0.51|1.31|||||A hazard ratio >1 indicates that the time to 65% or more reduction in uNTx from baseline was shorter in the Denosumab-treated group than in the control group.||
1764822|NCT00091832|3240011|Superiority or Other||Odds Ratio (OR)|0.7||||||95.0|0.25|1.92|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764823|NCT00091832|3240011|Superiority or Other||Odds Ratio (OR)|0.58||||||95.0|0.22|1.58|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764824|NCT00091832|3240011|Superiority or Other||Odds Ratio (OR)|0.65||||||95.0|0.24|1.77|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764825|NCT00091832|3240011|Superiority or Other||Odds Ratio (OR)|0.67||||||95.0|0.25|1.76|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764826|NCT00091832|3240011|Superiority or Other||Odds Ratio (OR)|1.82||||||95.0|0.69|4.79|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764827|NCT00091832|3240012|Superiority or Other||Odds Ratio (OR)|1.74||||||95.0|0.7|4.34|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764828|NCT00091832|3240012|Superiority or Other||Odds Ratio (OR)|1.27||||||95.0|0.51|3.2|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764829|NCT00091832|3240012|Superiority or Other||Odds Ratio (OR)|0.88||||||95.0|0.34|2.29|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764830|NCT00091832|3240012|Superiority or Other||Odds Ratio (OR)|1.29||||||95.0|0.51|3.24|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764831|NCT00091832|3240012|Superiority or Other||Odds Ratio (OR)|1.72||||||95.0|0.68|4.35|||||Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)||
1764832|NCT00091832|3240013|Superiority or Other|||||||0.848|||||||ANCOVA|Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||
1764833|NCT00091832|3240014|Superiority or Other|||||||0.245|||||||ANCOVA|Adjusted for the stratum to which the participant was originally assigned by the Interactive Voice Response System (IVRS)|||
1764834|NCT00091819|3240015|Non-Inferiority or Equivalence|Non-inferiority margin of 10% was specified based on historical regulatory precedent.|Risk Difference (RD)|1.0||||||95.0|-4.8|6.8|||||"Statistical analysis applies to cure"||
1764835|NCT00091793|3240024|Superiority or Other||Mean Difference (Final Values)|7.0|||<|0.0001||95.0|6.2|7.8|||ANCOVA||||
1764836|NCT00091572|3240026|Superiority or Other||Odds Ratio (OR)|1.43||||0.0718||95.0|0.97|2.12|||Cochran-Mantel-Haenszel||Temozolomide numerator (responders) = 55. Dacarbazine numerator (responders) = 37.||
1764837|NCT00091572|3240027|Superiority or Other||Hazard Ratio (HR)|1.0||||0.9999||95.0|0.86|1.17|||Log Rank||Temozolomide events (deaths) = 320. Dacarbazine events (deaths) = 325.||
1764838|NCT00091572|3240028|Superiority or Other||Hazard Ratio (HR)|0.92||||0.2663||95.0|0.8|1.06|||Log Rank||Temozolomide events (progressions/deaths) = 401. Dacarbazine events (progressions/deaths) = 398.||
1764839|NCT00091507|3240029|Superiority or Other||Odds Ratio (OR)|0.48||||0.01|2-Sided|95.0|0.27|0.85|||Regression, Logistic||||
1764840|NCT00091507|3240030|Superiority or Other||Hazard Ratio (HR)|0.72||||0.27|2-Sided|95.0|0.4|1.29|||Regression, Logistic||||
1764841|NCT00091507|3240031|Superiority or Other||Hazard Ratio (HR)|0.73||||0.24|2-Sided|95.0|0.43|1.23|||Regression, Logistic||||
1764842|NCT00091507|3240032|Superiority or Other||Odds Ratio (OR)|0.56||||0.08|2-Sided|95.0|0.3|1.07|||Regression, Logistic||||
1764843|NCT00091507|3240033|Superiority or Other||Odds Ratio (OR)|0.88||||0.28|2-Sided|95.0|0.66|1.13|||Regression, Logistic||||
1764844|NCT00091442|3240034|Superiority or Other||Hazard Ratio (HR)|0.65|||<|0.0001||95.0|0.55|0.77|||Log Rank|||"Null hypothersis - no difference in Time to Progression (TTP) between the two treatment groups.~Designed to detect an improvement in median TTP from 6 months to 7.8 months with 80% power, assuming exponential survival distribution."|
1764845|NCT00091442|3240035|Superiority or Other|||||||0.0085||||||Not adjusted for multiple comparison|Cochran-Mantel-Haenszel|||Null hypothesis - no difference in response rate between the two treatment groups.|
1764846|NCT00091442|3240036|Superiority or Other||Hazard Ratio (HR)|1.06||||0.5988||95.0|0.86|1.3||Not adjusted for multiple comparison.|Log Rank|||Null Hypothesis: Designed to detect an improvement in median survival from 15 months to 19.5 months with 80% power.|
1764847|NCT00091390|3240042|Superiority or Other||hazard rate|0.0014|||<|0.0001|2-Sided|95.0|0.0|0.003|||Z-test|One-sided.||The study is designed to test whether the 18-month late GU/GI toxicity following the protocol treatment is above 10% (hazard rate of 0.012/month). The sample size is determined so that the probability of rejecting the treatment because of excessive late toxicity is 90% if the true late toxicity rate is 20% (hazard rate of 0.025/month). Ninety-eight patients are required to with an additional 18 months of follow-up to have a statistical power of 90% with one-sided significance level of 0.05.|
1764848|NCT00091169|3240049|Superiority or Other|||||||0.677|||||||Fisher Exact||||
1764849|NCT00091169|3240050|Superiority or Other|||||||1e-05|||||||Fisher Exact||||
1764850|NCT00091169|3240051|Superiority or Other|||||||0.61|||||||Wilcoxon (Mann-Whitney)||||
1764851|NCT00091169|3240052|Superiority or Other|||||||0.93|||||||Wilcoxon (Mann-Whitney)||||
1764852|NCT00091169|3240053|Superiority or Other|||||||0.64|||||||Wilcoxon (Mann-Whitney)||||
1764853|NCT00091169|3240054|Superiority or Other|||||||0.57|||||||Wilcoxon (Mann-Whitney)||||
1764854|NCT00091026|3240055|Superiority or Other|||||||0.86|||||||Log Rank||||
1764855|NCT00091026|3240056|Superiority or Other|||||||0.95|||||||Log Rank||||
1764865|NCT00090857|3240076|Superiority or Other|||||||0.06|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.|
1764866|NCT00090857|3240077|Superiority or Other|||||||0.03|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.|
1764867|NCT00090857|3240078|Superiority or Other|||||||0.7|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.|
1764868|NCT00090857|3240079|Superiority or Other|||||||0.15|||||||Wilcoxon (Mann-Whitney)|||Sample size for a detectable difference in the within participant change in bone density between arms was calculated using standard deviations of one year change in bone density. Control estimates were 2.8% for spine and 3.85% for femoral neck. With 100 patients and 2:1 randomization (67 letrozole: 33 placebo), using a 1-sided Wilcoxon rank sum test with size 0.05, there is 80% power to detect as significant a true difference in change in the spine of 1.6% and in the femoral neck of 2.27%.|
1764869|NCT00090779|3240092|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1764870|NCT00090779|3240093|Superiority or Other|||||||0.005|||||||Wilcoxon (Mann-Whitney)||||
1764871|NCT00090584|3240114|Superiority or Other||Odds Ratio (OR)|3.17|||<|0.0001|2-Sided|95.0|1.83|5.52|||Regression, Logistic|Controlling for clinical site and randomization stratum||Null hypothesis: No difference in perceived improvement at 8 months between women in combination therapy group compared to those in drug only group.|
1764872|NCT00090584|3240115|Superiority or Other||Odds Ratio (OR)|2.55||||0.008|2-Sided|95.0|1.27|5.13||P-value from logistic regression analysis|Regression, Logistic|Controlling for clinical site and randomization stratum||Null hypothesis: No difference in perceived improvement between women in combination therapy group compared to those in drug only group|
1764873|NCT00090584|3240116|Superiority or Other||Odds Ratio (OR)|2.03||||0.02|2-Sided|95.0|1.11|3.7|||Regression, Logistic|Controlling for clinical site and randomization stratum|Ratio of odds of complete satisfaction in combination therapy group compared to drug only group.|Null hypothesis: No difference in satisfaction at 8 months post intervention|
1764874|NCT00090584|3240117|Superiority or Other||Odds Ratio (OR)|1.79||||0.02|2-Sided|95.0|1.09|2.92|||Regression, Logistic|Controlling for clinical site and randomization stratum|Ratio of odds of complete satisfaction in Combination therapy arm to Drug only arm.|Null hypothesis: no difference in satisfaction at 10 weeks|
1764875|NCT00090584|3240118|Superiority or Other||Other|0.0||||0.0005||95.0||||P-value for test of time by treatment group interaction.|Mixed Models Analysis|Adjusted for study site||Repeated measures analysis of difference in symptom bother over time by treatment group.|
1764876|NCT00090584|3240119|Superiority or Other||Other|0.0||||0.0006||95.0||||Repeated measures ANOVA|Mixed Models Analysis|Main hypothesis tested by F-test for treatment by time interaction (2 and 509 degrees of freedom). No parameters estimated.||Null hypothesis is that there is no difference between treatment groups in improvement in UDI over time|
1764877|NCT00090584|3240120|Superiority or Other||Mean Difference (Net)|-0.8|Standard Error of the Mean|0.5||0.08|2-Sided|95.0|-1.7|0.1||Repeated measures ANOVA controlling for clinical site.|ANOVA||Difference (group 1 - group 2) in change from baseline to follow-up in voids per day.|Null hypothesis of no difference between arms in change in number of voids per day from baseline to 10 weeks.|
1764878|NCT00090584|3240121|Superiority or Other||Mean Difference (Net)|1.9|Standard Error of the Mean|2.0||0.34|2-Sided|95.0|-2.0|5.9||Mixed effect repeated measures analysis of variance controlling for study site.|ANOVA|||Test of hypothesis of no difference in change in episodes between the two groups.|
1764879|NCT00090584|3240122|Superiority or Other||Difference in cumulative success rates|0.0|Standard Error of the Mean|0.06||0.74|2-Sided|95.0|-0.12|0.12|||Log Rank|||Kaplan Meier Lifetable analysis was used to compute the 8 month cumulative success rates.|
1764880|NCT00090519|3240123|Superiority or Other||Odds Ratio (OR)|0.47||||0.081|2-Sided|95.0|0.2|1.12||P-value is for occurrence of sustained moderate visual loss (SMVL) in a diabetic retinopathy (DR) study eye yes versus no.|Chi-squared||||
1764881|NCT00090519|3240125|Superiority or Other||Mean Difference (Final Values)|1.52||||0.009|2-Sided|95.0|0.38|2.66||P-value is for change from baseline.|ANCOVA||||
1764882|NCT00090519|3240126|Superiority or Other||Mean Difference (Final Values)|63.22||||0.365|2-Sided|95.0|-73.68|200.12||P-value is for change from baseline.|t-test, 2 sided||||
1764883|NCT00090519|3240127|Superiority or Other||Mean Difference (Final Values)|1.52||||0.211|2-Sided|95.0|-0.87|3.92||P-value is for change from baseline.|ANCOVA||||
1764884|NCT00090519|3240128|Superiority or Other|||||||0.475||||||P-value is for progression of nonproliferative diabetic retinopathy (DR) by seven-field stereo fundus photography progression versus no progression.|Chi-squared||||
1764885|NCT00090519|3240129|Superiority or Other||Mean Difference (Final Values)|0.45||||0.041|2-Sided|95.0|0.02|0.87||P-value is for change from baseline.|ANCOVA||||
1764886|NCT00090519|3240130|Superiority or Other|||||||0.577||||||P-value is for first occurrence of focal/grid photocoagulation yes versus no.|Chi-squared||||
1764887|NCT00090519|3240131|Superiority or Other||Mean Difference (Final Values)|1.09||||0.015|2-Sided|95.0|0.21|1.97||P-value is for change from baseline.|ANCOVA||||
1764888|NCT00090519|3240132|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.969|2-Sided|95.0|-0.714|0.686|||ANOVA||||
1765903|NCT00070707|3241998|Superiority or Other|||||||0.116|||||||ANOVA|||Baseline (AM)|
1764889|NCT00090285|3240156|Superiority or Other||Risk Difference (RD)|51.0||||||95.0|40.3|59.9|||||CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.||
1764890|NCT00090285|3240157|Superiority or Other||Risk Difference (RD)|85.5||||||95.0|77.0|91.3|||||CI based on binomial tail probabilities and not from a dispersion parameter. Hochberg multiplicity adjustment applied to the CI.||
1764891|NCT00090285|3240158|Superiority or Other||Risk Difference (RD)|77.5||||||95.0|39.6|93.3|||||||
1764892|NCT00090285|3240166|Superiority or Other||Risk Difference (RD)|90.6||||||95.0|70.1|98.2|||||Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter.||
1764893|NCT00090259|3240167|Superiority or Other||Hazard Ratio (HR)|0.892||||0.023|2-Sided|95.0|0.808|0.984|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg||
1764894|NCT00090259|3240168|Superiority or Other||Hazard Ratio (HR)|0.865||||0.025|2-Sided|95.0|0.762|0.982|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg||
1764895|NCT00090259|3240169|Superiority or Other||Hazard Ratio (HR)|0.936||||0.235|2-Sided|95.0|0.84|1.044|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg||
1764896|NCT00090259|3240170|Superiority or Other||Hazard Ratio (HR)|0.924||||0.068|2-Sided|95.0|0.848|1.006|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg||
1764897|NCT00090259|3240171|Superiority or Other||Hazard Ratio (HR)|0.899||||0.027|2-Sided|95.0|0.818|0.988|||Regression, Cox|Model terms: treatment, region and β-blocker use at randomization|Direction of the Comparison: Hazard Ratio of experiencing the endpoint on Losartan 150 mg compared to Losartan 50 mg||
1764898|NCT00090233|3240172|Non-Inferiority or Equivalence|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 23F|1.1|||<|0.001|2-Sided|95.0|0.9|1.5|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 23F was used for analysis.|
1764899|NCT00090233|3240172|Non-Inferiority or Equivalence|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 19F|1.1|||<|0.001|2-Sided|95.0|0.8|1.4|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 19F was used for analysis.|
1764900|NCT00090233|3240172|Non-Inferiority or Equivalence|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 18C|1.3|||<|0.001|2-Sided|95.0|1.1|1.6|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 18C was used for analysis.|
1764901|NCT00090233|3240172|Non-Inferiority or Equivalence|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 14|1.0|||<|0.001|2-Sided|95.0|0.7|1.3|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 14 was used for analysis.|
1764902|NCT00090233|3240172|Non-Inferiority or Equivalence|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 9V|1.1|||<|0.001|2-Sided|95.0|0.9|1.3|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 9V was used for analysis.|
1764903|NCT00090233|3240172|Non-Inferiority or Equivalence|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 6B|1.4|||<|0.001|2-Sided|95.0|1.0|1.9|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 6B was used for analysis.|
1764904|NCT00090233|3240172|Non-Inferiority or Equivalence|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for pneumococcal serotype 4|1.2|||<|0.001||95.0|1.0|1.4|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 4 was used for analysis.|
1764905|NCT00090233|3240173|Non-Inferiority or Equivalence|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis Pertactin|0.6||||0.193|2-Sided|95.0|0.4|0.8|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis Pertactin was used for analysis.|
1764906|NCT00090233|3240173|Non-Inferiority or Equivalence|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis FHA|0.9|||<|0.001|2-Sided|95.0|0.7|1.1|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis FHA was used for analysis.|
1764907|NCT00090233|3240173|Non-Inferiority or Equivalence|GMTR was greater than 0.5 (non-inferiority margin).|GMTR for Pertussis PT|0.9|||<|0.001|2-Sided|95.0|0.7|1.1|||t-test, 1 sided|t-test on natural log of titers||The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis PT was used for analysis.|
1764908|NCT00090233|3240174|Non-Inferiority or Equivalence|Difference (vaccine-placebo) in seroprotection rates was greater than -.10 (non-inferiority margin).|||||<|0.001||||||p<0.001 was obtained for all comparisons. pv - pp ≥-.10, where p is proportion of participants who achieved seroprotection in the vaccine and placebo groups, respectively.|Miettenen and Nurminen||||
1764909|NCT00090233|3240175|Superiority or Other||Efficacy=1-Relative Risk|98.0|||<|0.001||95.0|88.3|100.0||Efficacy>0%. Based on p< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.|Exact binomial test||||
1764910|NCT00090233|3240176|Superiority or Other||Efficacy=1-Relative Risk|81.5|||<|0.001||95.0|74.9|86.7||Efficacy>0%. Based on p< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.|Exact binomial test||Estimated value is based on the worst episode scores.||
1764947|NCT00089843|3240311|Superiority or Other||Percent change between 0 and 12 months|3.2|||<|0.0001|2-Sided|95.0|1.8|4.6||This p value was for the effect of Actonel (risedronate) on bone mineral density of the spine.|Factorial analysis|||Factorial analysis|
1764948|NCT00089791|3240312|Superiority or Other (legacy)||Hazard Ratio (HR)|0.6||||0.0362||95.0|0.37|0.97|||Regression, Cox||||
1764911|NCT00090233|3240177|Superiority or Other||Risk Ratio (RR)|94.5|||<|0.001||95.0|91.2|96.6||Rate Reduction>0%|Poisson regression|"Poisson regression with generalized estimating equations.~Validated with Van Elteren’s extension of Wilcoxon Rank Sum test."|Risk ratio of rate of hospitalizations and emergency department visits between treatment groups. Reported here are results after 12 additional emergency department visits were identified among placebo recipients and data were re-analyzed.||
1764912|NCT00090233|3240178|Superiority or Other||Efficacy=1-Relative Risk|74.0|||<|0.001||95.0|66.8|79.9||"Efficacy≥35%. Based on p≤.65/(.65+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, k is ratio of follow-up time; placebo/vaccine.~Based on conditional binomial approach."|Exact binomial test|Exact binomial test.|Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.||
1764913|NCT00090233|3240179|Superiority or Other||Proportion|81.2|||<|0.001||95.0|72.9|87.8||p≥42%, where p is proportion of participants with ≥3-fold rise in antibody titer from Predose 1 to Postdose 3 in vaccine group. Based on binomial approach.|Exact binomial test||||
1764914|NCT00090233|3240180|Non-Inferiority or Equivalence|Relative Risk ≤10.0 (non-inferiority margin).|relative risk|1.6||||0.006||95.0|0.4|6.4||"p≤ 10/11, where p is proportion of participants with intussusception in vaccine group relative to total number of participants with intussusception. Based on conditional binomial approach.~Adjusted for group-sequential design."|Exact binomial test|Exact binomial test adjusted for group-sequential design.|||
1764915|NCT00090220|3240187|Superiority or Other||Percent Relative Risk Reduction|84.7||||||95.0|67.5|93.7|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.||
1764916|NCT00090220|3240195|Superiority or Other||Percent Relative Risk Reduction|94.8||||||95.0|79.9|99.4|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.||
1764917|NCT00090220|3240221|Superiority or Other||Percent Relative Risk Reduction|88.7||||||95.0|78.1|94.8|||||Confidence Interval based on binomial tail probabilities and not from a dispersion parameter.||
1764918|NCT00090402|3240224|Superiority or Other|||||||0.83|||||||Regression, Linear|Adjusted for age and body mass index|||
1764919|NCT00090103|3240261|Superiority or Other|||||||0.24|||||||Log Rank|Mantel-Haenszel test with stratification by cluster.|||
1764920|NCT00090103|3240261|Superiority or Other|||||||0.95|||||||Log Rank|Mantel-Haenszel test with stratification by cluster.|||
1764921|NCT00090103|3240262|Superiority or Other|||||||0.1|||||||Log Rank|Mantel-Hanenszel test with stratification by cluster.|||
1764922|NCT00090103|3240262|Superiority or Other|||||||0.65|||||||Log Rank|Mantel-Haenszel test with stratification by cluster.|||
1764923|NCT00090103|3240263|Superiority or Other||Relative Risk Estimate|0.59|||<|0.001||95.0|0.48|0.72|||Log Rank||||
1764924|NCT00090103|3240263|Superiority or Other||Relative Risk Estimate|0.65|||<|0.001||95.0|0.52|0.8|||Log Rank|Log-rank test with stratification by cluster.|||
1764925|NCT00090103|3240265|Superiority or Other||||||<|0.001||||||Log rank test with stratification by cluster.|Log Rank||||
1764926|NCT00090103|3240265|Superiority or Other||||||<|0.18||||||Log rank test with stratification by cluster.|Log Rank||||
1764927|NCT00090103|3240267|Superiority or Other||Relative Risk Estimate|0.34|||<|0.001||95.0|0.26|0.45||Log-rank test with stratification by cluster.|Log Rank||||
1764928|NCT00090103|3240267|Superiority or Other||Relative Risk Estimate|0.8|||<|0.18||95.0|0.58|1.11||Log-rank test with stratification by cluster.|Log Rank||||
1764929|NCT00090051|3240268|Superiority or Other||Hazard Ratio (HR)|0.68||||0.0002|2-Sided|95.0|0.55|0.84|||Log Rank||||
1764930|NCT00090051|3240269|Superiority or Other||Hazard Ratio (HR)|0.65||||0.0007|2-Sided|95.0|0.51|0.84|||Log Rank||||
1764931|NCT00090051|3240270|Superiority or Other||Hazard Ratio (HR)|0.77||||0.3085|2-Sided|95.0|0.46|1.28|||Log Rank||||
1764932|NCT00090051|3240271|Superiority or Other||Odds Ratio (OR)|2.15||||0.0005|2-Sided|95.0|1.39|3.35|||Chi-squared||||
1764933|NCT00090051|3240272|Superiority or Other||Hazard Ratio (HR)|0.65|||<|0.0001|2-Sided|95.0|0.54|0.79|||Log Rank||||
1764934|NCT00090051|3240273|Superiority or Other||Hazard Ratio (HR)|0.94||||0.5976|2-Sided|95.0|0.74|1.19|||Log Rank||||
1764935|NCT00090051|3240274|Superiority or Other||Hazard Ratio (HR)|0.66|||<|0.0001|2-Sided|95.0|0.54|0.8|||Log Rank||||
1764936|NCT00090051|3240276|Superiority or Other|||||||0.8842|||||||Log Rank|non-stratified|||
1764937|NCT00090051|3240279|Superiority or Other|||||||0.0002|||||||Log Rank|non-stratified|||
1764938|NCT00090051|3240281|Superiority or Other|||||||0.2874|||||||Log Rank|non-stratified|||
1764939|NCT00090051|3240282|Superiority or Other||Hazard Ratio (HR)|0.76||||0.0218|2-Sided|95.0|0.6|0.96|||Log Rank|non-stratified|The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the fludarabine+cyclophosphamide(FC) group.|The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the fludarabine+cyclophosphamide+rituximab (FCR) group.|
1764940|NCT00089999|3240292|Superiority or Other||Odds Ratio (OR)|0.7||||0.443|2-Sided|95.0|0.3|1.6|||Fisher Exact||Overall Response (i.e. sum of Complete and Partial Responses) comparison||
1764941|NCT00089999|3240293|Superiority or Other||Odds Ratio (OR)|0.8||||0.691|2-Sided|95.0|0.3|1.9|||Fisher Exact||||
1764942|NCT00089986|3240297|Superiority or Other||Rate Difference|-4.4||||0.879|1-Sided|90.0|-9.4||||Chi-squared||||
1764943|NCT00089986|3240297|Superiority or Other||Rate difference|1.1||||0.329|1-Sided|90.0|-2.1||||Chi-squared||||
1764944|NCT00089843|3240310|Superiority or Other||Percent change between 0 and 12 months|-11.0||||0.39||95.0||||This p value was for the effect of testosterone.|Factorial analysis|||Factorial analysis|
1764945|NCT00089843|3240310|Superiority or Other||Percent change between 0 and 12 months|-41.0||||0.002|2-Sided|95.0||||This p value was for the effect of Actonel (risedronate).|Factorial analysis|||Factorial analysis|
1764946|NCT00089843|3240311|Superiority or Other||Percent change between 0 and 12 months|-0.6||||0.41|2-Sided|95.0|-2.0|0.8||This p value was for the effect of testosterone on bone mineral density of the spine.|Factorial analysis|||Factorial analysis|
1764949|NCT00089791|3240313|Superiority or Other (legacy)||Hazard Ratio (HR)|0.8||||0.0106||95.0|0.67|0.95|||Regression, Cox||||
1764950|NCT00089791|3240314|Superiority or Other (legacy)||Risk Ratio (RR)|0.32|||<|0.0001||95.0|0.26|0.41||Logistic regression was used to generate the p-value|Mantel Haenszel||||
1764951|NCT00089752|3240319|Non-Inferiority or Equivalence|Sample size was designed to achieve at least 80% power, using n 1⁄4 123 per group with an effect size of at least 0.36|Adjusted difference in mean change|-1.76||||0.09|2-Sided|95.0|-3.8|0.3||a priori threshold was p<0.05|ANCOVA|||Intent to Treat analysis with Last Observation Carried Forward.|
1764952|NCT00089674|3240325|Superiority or Other||Odds Ratio (OR)|0.7||||0.7961||95.0|0.44|1.11||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic||||
1764953|NCT00089674|3240326|Superiority or Other||Hazard Ratio (HR)|0.94||||0.7961||95.0|0.57|1.55||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Cox||||
1764954|NCT00089674|3240327|Superiority or Other||Odds Ratio (OR)|0.37||||0.0125||95.0|0.18|0.78||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic||||
1764955|NCT00089674|3240328|Superiority or Other||Odds Ratio (OR)|0.7||||0.1048||95.0|0.46|1.08||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|Regression, Logistic||||
1764956|NCT00089674|3240329|Superiority or Other||Mean Difference (Final Values)|5.7|||<|0.0001||95.0|5.4|6.1||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA||||
1764957|NCT00089674|3240330|Superiority or Other||Mean Difference (Final Values)|4.9|||<|0.0001||95.0|4.4|5.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA||||
1764958|NCT00089674|3240331|Superiority or Other||Mean Difference (Final Values)|7.9|||<|0.0001||95.0|7.4|8.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA||||
1764959|NCT00089674|3240332|Superiority or Other||Mean Difference (Final Values)|4.8|||<|0.0001||95.0|4.4|5.1||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA||||
1764960|NCT00089674|3240333|Superiority or Other||Mean Difference (Final Values)|3.9|||<|0.0001||95.0|3.5|4.4||Adjusted for multiplicity using the prespecified hierarchical analysis strategy and Hochberg procedure|ANCOVA||||
1764961|NCT00089674|3240334|Superiority or Other||Mean Difference (Final Values)|6.7|||<|0.0001||95.0|6.2|7.1|||ANCOVA||||
1764962|NCT00089661|3240340|Superiority or Other||Mean Difference (Final Values)|5.5|||<|0.0001||95.0|4.8|6.3|||ANCOVA||||
1764963|NCT00089648|3240353|Superiority or Other||Objective Response Rate (ORR) (percent)|23.0||||||95.0|13.2|35.5|||||ORR=proportion of subjects with confirmed CR or PR, relative to total number of subjects who received at least 1 dose of study medication, were refractory to bevacizumab, had a baseline disease assessment and had the correct histological cancer type.||
1764964|NCT00089609|3240406|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1764965|NCT00089505|3240419|Non-Inferiority or Equivalence|NoNVP/NVP regimen will be considered equivalent to the NoNVP/LPV_r regimen if the two-sided 95% confidence interval for the hazard ratio for virologi falure is entirely below 2.0; equivalence will be established if the same confidence interval is entirely within the range 0.5 to 2.0.|Hazard Ratio (HR)|0.85||||0.43|2-Sided|95.0|0.56|1.29||P-value is for a test of superiority and was not adjusted for interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used.|Regression, Cox|The cox proportional hazard model was stratified by screening CD4 strata (<50 vs. >=50 cells/mm3).|The HR is for NoNVP/NVP vs. NoNVP/LPV_r.||
1764966|NCT00089505|3240420|Superiority or Other||Hazard Ratio (HR)|3.69|||<|0.001|2-Sided|95.0|1.79|7.61||P-value was not adjusted for multiple interim analyses, but any adjustment would be negligible because Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.|Regression, Cox|The model was stratified by screening CD4 strata (<50 vs. >=50 cells/mm^3).|The HR is for NVP/NVP vs. NVP/LPV_r.||
1764967|NCT00089141|3240448|Superiority or Other||Hazard Ratio (HR)|1.51||||0.28||95.0|0.7|3.2|||Regression, Cox||||
1764968|NCT00089141|3240449|Superiority or Other||Hazard Ratio (HR)|1.28||||0.34||95.0|0.08|2.1|||Regression, Cox||||
1764969|NCT00089141|3240450|Superiority or Other||Hazard Ratio (HR)|1.99||||0.1||95.0|0.9|4.3|||Regression, Cox||||
1764970|NCT00089141|3240451|Superiority or Other||Hazard Ratio (HR)|1.69||||0.14||95.0|0.9|3.2|||Regression, Cox||||
1764971|NCT00089141|3240452|Superiority or Other||Hazard Ratio (HR)|1.62||||0.41||95.0|0.5|5.0|||Regression, Cox||||
1764972|NCT00089141|3240453|Superiority or Other||Hazard Ratio (HR)|1.74||||0.17||95.0|0.8|3.9|||Regression, Cox|adjusted for risk category|||
1764973|NCT00089141|3240454|Superiority or Other||Hazard Ratio (HR)|1.61||||0.48||95.0|0.4|6.0|||Regression, Cox||||
1764974|NCT00089141|3240455|Superiority or Other||Hazard Ratio (HR)|1.19||||0.55||95.0|0.7|2.1|||Regression, Cox||||
1764975|NCT00089141|3240456|Superiority or Other||Hazard Ratio (HR)|1.65||||0.03||95.0|1.1|2.6|||Regression, Cox|Statistical analysis did not count treatment continuing beyond 2 years as efficacy failure (n = 2 in each arm).|||
1764976|NCT00089141|3240457|Superiority or Other||Hazard Ratio (HR)|1.66||||0.22||95.0|0.7|3.7||P values are 2 sided and are based on likelihood ratio statistics.|Regression, Cox|Analysis for all endpoints was stratified by number of affected organs and type of conditioning regimen.|For all analyses, MMF arm in numerator, and placebo arm in denominator. Hazard ratio estimate includes 3 efficacy success events that occurred after two years in the placebo arm.||
1764977|NCT00088907|3240489|Superiority or Other|||||||0.19|||||||Log Rank||||
1764978|NCT00088907|3240490|Superiority or Other|||||||0.6|||||||Log Rank||||
1764979|NCT00088634|3240498|Superiority or Other||||||<|0.05|||||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline MADRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.|
1764980|NCT00088634|3240499|Superiority or Other||||||<|0.05|||||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline CGI-S score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.|
1764981|NCT00088634|3240500|Superiority or Other||||||<|0.05|||||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline PANSS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.|
1764982|NCT00088634|3240501|Superiority or Other||||||<|0.05|||||||ANCOVA|||Comparisons between SM-13496 and placebo will be performed by means of a 2-way analysis of covariance (ANCOVA) model with treatment group and study center as factors, and baseline BPRS score as a covariate. Ninety-five percent (95%) confidence intervals will be constructed using the variability estimates from the ANCOVA model.|
1764983|NCT00088153|3240554|Superiority or Other||||||<|0.05||||||The p value was adjusted for age and weight changes|t-test, 2 sided|||The null hypothesis was that the groups would not differ for changes in spine bone density z-scores over the study duration|
1764984|NCT00088153|3240555|Superiority or Other||||||>|0.05|||||||t-test, 2 sided|||The null hypothesis was that there would be no differences between the groups for changes in P1NP levels over time|
1764985|NCT00088153|3240556|Superiority or Other||||||<|0.05||||||After controlling for baseline age and weight changes|t-test, 2 sided|We also used a mixed model analysis of variance (PROC MIXED), to analyze longitudinal data.||Power analysis: We have previously demonstrated that normal female adolescents gain bone density at the rate of 0.039 +/- 0.0507 per year. The pooled SD in that study was 0.046. Based on these data, with a sample size of 110 girls with anorexia nervosa (AN), half of whom are randomized to receive estrogen and half placebo (with a 10% drop-out rate), there will be an 80% chance that we will detect an increase in bone density to 75% of normal in the girls who receive estrogen.|
1764986|NCT00087646|3240569|Superiority or Other||Odds Ratio (OR)|1.17||||0.3389|2-Sided|95.0|0.85|1.6|||Cochran-Mantel-Haenszel|||Groups A vs Groups D (Week 24)|
1764987|NCT00087646|3240569|Superiority or Other||Odds Ratio (OR)|2.31|||<|0.0001|2-Sided|95.0|1.67|3.19|||Cochran-Mantel-Haenszel|||Groups A vs Groups D (Week 12)|
1764988|NCT00087646|3240570|Superiority or Other||Odds Ratio (OR)|1.36||||0.0883|2-Sided|95.0|0.95|1.93|||Cochran-Mantel-Haenszel|||At Week 48|
1764989|NCT00087646|3240570|Superiority or Other||Odds Ratio (OR)|1.26||||0.1955|2-Sided|95.0|0.89|1.79|||Cochran-Mantel-Haenszel|||At Week 24|
1764990|NCT00087646|3240570|Superiority or Other||Odds Ratio (OR)|2.64|||<|0.0001|2-Sided|95.0|1.66|4.18|||Cochran-Mantel-Haenszel|||At Week 12|
1764991|NCT00087646|3240571|Superiority or Other||Odds Ratio (OR)|2.22||||0.0006|2-Sided|95.0|1.4|3.52|||Cochran-Mantel-Haenszel||||
1764992|NCT00087646|3240572|Superiority or Other||Odds Ratio (OR)|0.98||||0.9228|2-Sided|95.0|0.63|1.51|||Cochran-Mantel-Haenszel||||
1764993|NCT00087646|3240573|Superiority or Other||Odds Ratio (OR)|2.0||||0.006|2-Sided|95.0|1.21|3.31|||Cochran-Mantel-Haenszel|||Group A Vs Group D|
1764994|NCT00087633|3240575|Superiority or Other||Mean Difference (Final Values)|-3.2||||0.725|2-Sided|95.0|-20.8|14.4|||Cochran-Mantel-Haenszel||||
1764995|NCT00087607|3240579|Superiority or Other||||||<|0.001|||||||Repeated measures analysis|||Week 8: The treatment groups were compared using Repeated measures analysis|
1764996|NCT00087607|3240579|Superiority or Other||||||<|0.024|||||||Repeated measures analysis|The P-value is determined from a repeated measures analysis with terms for treatment group, baseline, week, and the week-by-treatment interaction.||Week 1: The treatment groups were compared using repeated measures analysis|
1764997|NCT00087607|3240584|Superiority or Other||Difference in proportion of participants|-4.8||||0.3399|2-Sided|95.0|-14.7|5.1|||Chi-squared|||Week 12: Treatment groups were compared using the Chi-Square Test.|
1764998|NCT00087607|3240584|Superiority or Other||Difference in proportion of participants|-2.7||||0.5876|2-Sided|95.0|-12.6|7.1|||Chi-squared|||Week 11: Treatment groups were compared using the Chi-Square Test.|
1764999|NCT00087607|3240584|Superiority or Other||Difference in proportion of participants|-5.4||||0.2779|2-Sided|95.0|-15.1|4.3|||Chi-squared|||Week 10: Treatment groups were compared using the Chi-Square Test.|
1765000|NCT00087607|3240584|Superiority or Other||Difference in proportion of participants|-6.0||||0.2144|2-Sided|95.0|-15.4|3.4|||Chi-squared|||Week 9: Treatment groups were compared using the Chi-Square Test.|
1765001|NCT00087607|3240584|Superiority or Other||Difference in proportion of participants|-3.4||||0.4595|2-Sided|95.0|-12.4|5.6|||Chi-squared|||Week 8: Treatment groups were compared using the Chi-Square Test.|
1765002|NCT00087607|3240584|Superiority or Other||Difference in proportion of participants|-4.5||||0.3099|2-Sided|95.0|-13.1|4.2|||Chi-squared|||Week 7: Treatment groups were compared using the Chi-Square Test.|
1765003|NCT00087607|3240584|Superiority or Other||Difference in proportion of participants|-6.6||||0.108|2-Sided|95.0|-14.7|1.4|||Chi-squared|||Week 6: Treatment groups were compared using the Chi-Square Test.|
1765004|NCT00087607|3240584|Superiority or Other||Difference in proportion of participants|-4.6||||0.1888|2-Sided|95.0|-11.4|2.2|||Chi-squared|||Week 5: Treatment groups were compared using the Chi-Square Test.|
1765005|NCT00087607|3240584|Superiority or Other||Difference in proportion of participants|-4.1||||0.1713|2-Sided|95.0|-10.0|1.8|||Chi-squared|||Week 4: Treatment groups were compared using the Chi-Square Test.|
1765006|NCT00087607|3240584|Superiority or Other||Difference in proportion of participants|-3.6||||0.0864|2-Sided|95.0|-7.8|0.5|||Chi-squared|||Week 3: Treatment groups were compared using the Chi-Square Test.|
1765007|NCT00087607|3240584|Superiority or Other||Difference in proportion of participants|-0.5||||0.7133|2-Sided|95.0|-3.2|2.2|||Chi-squared|||Week 2: Treatment groups were compared using the Chi-Square Test.|
1765008|NCT00087607|3240584|Superiority or Other||Difference in proportion of participants|0.0||||0.994|2-Sided|95.0|-1.4|1.5|||Chi-squared|||Week 1: Treatment groups were compared using the Chi-Square Test.|
1765009|NCT00087607|3240585|Superiority or Other||Difference in proportion of participants|2.8||||0.5697|2-Sided|95.0|-6.8|12.4|||Chi-squared|||Week 12: Treatment groups were compared using the Chi-Square Test.|
1765010|NCT00087607|3240585|Superiority or Other||Difference in proportion of participants|5.4||||0.2779|2-Sided|95.0|-4.3|15.1|||Chi-squared|||Week 11: Treatment groups were compared using the Chi-Square Test.|
1765011|NCT00087607|3240585|Superiority or Other||Difference in proportion of participants|5.4||||0.276|2-Sided|95.0|-4.3|15.1|||Chi-squared|||Week 10: Treatment groups were compared using the Chi-Square Test.|
1765012|NCT00087607|3240585|Superiority or Other||Difference in proportion of participants|2.2||||0.6637|2-Sided|95.0|-7.7|12.1|||Chi-squared|||Week 9: Treatment groups were compared using the Chi-Square Test.|
1765013|NCT00087607|3240585|Superiority or Other||Difference in proportion of participants|2.2||||0.6593|2-Sided|95.0|-7.6|12.1|||Chi-squared|||Week 8: Treatment groups were compared using the Chi-Square Test.|
1765014|NCT00087607|3240585|Superiority or Other||Difference in proportion of participants|-0.4||||0.9295|2-Sided|95.0|-10.4|9.5|||Chi-squared|||Week 7: Treatment groups were compared using the Chi-Square Test.|
1765015|NCT00087607|3240585|Superiority or Other||Difference in proportion of participants|-2.1||||0.6871|2-Sided|95.0|-12.1|8.0|||Chi-squared|||Week 6: Treatment groups were compared using the Chi-Square Test.|
1765016|NCT00087607|3240585|Superiority or Other||Difference in proportion of participants|-6.8||||0.1823|2-Sided|95.0|-16.9|3.2|||Chi-squared|||Week 5: Treatment groups were compared using the Chi-Square Test.|
1765017|NCT00087607|3240585|Superiority or Other||Difference in proportion of participants|-7.4||||0.1467|2-Sided|95.0|-17.4|2.6|||Chi-squared|||Week 4: Treatment groups were compared using the Chi-Square Test.|
1765018|NCT00087607|3240585|Superiority or Other||Difference in proportion of participants|-10.7||||0.0315|2-Sided|95.0|-20.3|-1.0|||Chi-squared|||Week 3: Treatment groups were compared using the Chi-Square Test.|
1765019|NCT00087607|3240585|Superiority or Other||Difference in proportion of participants|-10.3||||0.0214|2-Sided|95.0|-18.9|-1.6|||Chi-squared|||Week 2: Treatment groups were compared using the Chi-Square Test.|
1765020|NCT00087607|3240585|Superiority or Other||Difference in proportion of participants|-3.1||||0.2814|2-Sided|95.0|-8.6|2.5|||Chi-squared|||Week 1: Treatment groups were compared using the Chi-Square Test.|
1765021|NCT00087607|3240587|Superiority or Other|||||||0.304|||||||ANOVA|||The treatment groups were compared using an analysis of variance (ANOVA) with treatment as the only factor in the model.|
1765022|NCT00087607|3240591|Superiority or Other||Mean Difference (Net)|-0.07||||0.688|2-Sided|95.0|-0.27|0.41|||t-test, 2 sided|||At Week 8: Mean treatment difference was tested using a two-sided t-test.|
1765023|NCT00087607|3240591|Superiority or Other||Mean Difference (Net)|0.27||||0.08|2-Sided|95.0|-0.03|0.58|||t-test, 2 sided|||At Week 4: Mean treatment difference was tested using a two-sided t-test.|
1765024|NCT00087607|3240592|Superiority or Other||Mean Difference (Net)|0.01||||0.978|2-Sided|95.0|-0.35|0.36|||t-test, 2 sided|||Mean treatment difference was tested using a two-sided t-test.|
1765025|NCT00087594|3240606|Superiority or Other||Difference|-13.0|||||2-Sided|95.0|-77.2|50.5||||||95% CI for G1 participants with missing HCV-RNA at W 12|
1765026|NCT00087594|3240606|Superiority or Other||Difference|0.0|||||2-Sided|||||||||95% CI for G1 participants with non 2 log drop at W 12|
1765027|NCT00087594|3240606|Superiority or Other||Difference|44.0|||||2-Sided|95.0|12.0|76.9||||||95% CI for G1 participants with 2 log drop at W 12|
1765028|NCT00087594|3240606|Superiority or Other||Difference|13.0|||||2-Sided|95.0|-10.4|35.4||||||95% CI for G2/3 participants|
1765029|NCT00087594|3240606|Superiority or Other||Difference|7.0|||||2-Sided|95.0|-27.8|41.3||||||95% CI for G1 participants|
1765030|NCT00087555|3240617|Superiority or Other|||||||0.035|||||||Chi-squared||||
1765031|NCT00087555|3240617|Superiority or Other|||||||0.024|||||||Chi-squared||||
1765032|NCT00087555|3240617|Superiority or Other|||||||0.052|||||||Chi-squared||||
1765033|NCT00087529|3240618|Superiority or Other||LS mean difference|-1.08||||0.6237|2-Sided|95.0|-9.49|7.34|||Friedman ranked ANOVA test|||Treatment difference in LS means and the associated 95% confidence intervals were estimated from the ANOVA model, which included the following factors: Baseline EDSS (≤ 4.0 versus >4.0 points), prior treatment with interferon-beta or glatiramer acetate, and treatment group.|
1765034|NCT00087529|3240619|Superiority or Other||LS mean difference|-718.24||||0.0008|2-Sided|95.0|-1504.48|68.0|||Friedman ranked ANOVA test|||Treatment difference in least-squares (LS) means and the associated 95% confidence intervals were estimated from the analysis of variance (ANOVA) model, which included the following factors: Baseline EDSS (≤ 4.0 versus >4.0 points), prior treatment with interferon-beta or glatiramer acetate, and treatment group.|
1765035|NCT00087529|3240621|Superiority or Other||Hazard Ratio (HR)|0.773||||0.1442|2-Sided|95.0|0.546|1.093||Stratified using the following variables: Baseline EDSS (less than or equal to [≤] 4.0 versus >4.0 points) and prior treatment with interferon-beta or glatiramer acetate.|Log Rank||||
1765036|NCT00087516|3240625|Superiority or Other||Mean Difference (Net)|-54.1|Standard Error of the Mean|6.4|<|0.001||95.0|-66.7|-41.6|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline 2-hr PMG|||
1765037|NCT00087516|3240625|Superiority or Other||Mean Difference (Net)|-46.7|Standard Error of the Mean|6.5|<|0.001||95.0|-59.4|-34.1|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline 2-hr PMG|||
1765038|NCT00087516|3240626|Superiority or Other||Mean Difference (Net)|-21.3|Standard Error of the Mean|3.5|<|0.001||95.0|-28.2|-14.4|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline FPG|||
1765039|NCT00087516|3240626|Superiority or Other||Mean Difference (Net)|-17.1|Standard Error of the Mean|3.6|<|0.001||95.0|-24.1|-10.1|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline FPG|||
1765040|NCT00087516|3240627|Superiority or Other||Mean Difference (Net)|-0.94|Standard Error of the Mean|0.09|<|0.001||95.0|-1.11|-0.77|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline A1C|||
1765041|NCT00087516|3240627|Superiority or Other||Mean Difference (Net)|-0.79|Standard Error of the Mean|0.09|<|0.001||95.0|-0.96|-0.62|||ANCOVA|Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline A1C|||
1765042|NCT00087490|3240629|Superiority or Other|||||||0|||||||t-test, 2 sided||||
1765043|NCT00087490|3240630|Superiority or Other|||||||0|||||||t-test, 2 sided||||
1765044|NCT00087490|3240631|Superiority or Other|||||||0.016||||||Alpha = 0.05 was the level of significance if the null hypothesis was rejected.|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.|
1765045|NCT00087490|3240632|Superiority or Other|||||||0.022||||||Alpha = 0.05 was the level of significance if the null hypothesis was rejected.|Wilcoxon (Mann-Whitney)|||Null hypothesis was that there was no difference in the length of hospital stay between the treatment groups.|
1765046|NCT00087490|3240635|Non-Inferiority or Equivalence|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|15.0||||0|2-Sided|95.0|8.2|21.8|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.|
1765047|NCT00087490|3240636|Non-Inferiority or Equivalence|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|7.7||||0.051|2-Sided|95.0|0.0|15.4|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.|
1765048|NCT00087490|3240637|Non-Inferiority or Equivalence|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|16.6||||0|2-Sided|95.0|9.0|24.2|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.|
1765049|NCT00087490|3240638|Non-Inferiority or Equivalence|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|6.6||||0.127|2-Sided|95.0|-1.9|15.0|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.|
1765050|NCT00087490|3240639|Non-Inferiority or Equivalence|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|4.8||||0.09|2-Sided|95.0|-0.7|10.3|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.|
1765051|NCT00087490|3240640|Non-Inferiority or Equivalence|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|7.1||||0.048|2-Sided|95.0|0.1|14.2|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.|
1765052|NCT00087490|3240641|Non-Inferiority or Equivalence|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the FDA suggested boundary of delta= -0.10.|Percent Difference|3.9||||0.168|2-Sided|95.0|-1.7|9.5|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95% CI.|
1765053|NCT00087490|3240642|Non-Inferiority or Equivalence|Linezolid was claimed non-inferior to vancomycin if the lower limit of 95% CI for the difference in cure rate is greater than the Food and Drug Administration (FDA) suggested boundary of delta= -0.10.|Percent Difference|4.2||||0.249|2-Sided|95.0|-3.0|11.5|||Chi-squared|||The percent difference was calculated by percentage of participants cured in linezolid arm minus the percentage of participants cured in vancomycin arm along with 2-sided 95 percent (%) confidence interval (CI).|
1765054|NCT00087438|3240649|Superiority or Other|||||||0.013||||||Test statistic = [ln(estimated hazard rate) - ln(hypothesized hazard rates)] / [1/square root (number of patients with local progression by two years]. Reject null hypothesis at an alpha level of 0.05 if test statistics is less than -1.645.|z-test, one-sided|||Null hypothesis = 60% two-year local control (0.02128/mo. hazard rate); alternative = 80% (0.0093/mo.) assuming at least approximately exponential distribution of time to local progression. Using the asymptotic properties of the ratio of the logarithms of hazard rates, less than 18 cases of local progression were required for a Type I error rate of 0.05 with 80% power to detect a difference in local control rates at least this large. Hazard rate estimated using life table two-year estimates.|
1765055|NCT00087022|3240659|Superiority|||||||0.022|||||||Log Rank||||
1765056|NCT00087022|3240662|Superiority|||||||1.012|||||||Log Rank||||
1765057|NCT00087022|3240663|Superiority|||||||0.737|||||||Log Rank||||
1765058|NCT00086580|3240677|Superiority or Other||Mean Difference (Final Values)|0.04||||0.014|2-Sided|95.0|0.01|0.08|||Cochran-Mantel-Haenszel|CMH chi-square test for a difference in response rates between treatments stratified by Rai Stage Group.|||
1765059|NCT00086580|3240680|Superiority or Other||Cox Proportional Hazard|0.416|||<|0.001|2-Sided|95.0|0.25|0.69|||Regression, Cox|Cox proportional hazards model|||
1765060|NCT00086580|3240681|Superiority or Other||Cox Proportional Hazard|1.066||||0.819|2-Sided|95.0|0.619|1.836|||Regression, Cox|Cox proportional hazards model|||
1765061|NCT00086580|3240682|Superiority or Other||Cox Proportional Hazard|0.443|||<|0.001|2-Sided|95.0|0.292|0.671|||Regression, Cox||||
1765062|NCT00086580|3240683|Superiority or Other||Cox Proportional Hazard|0.75||||0.102|2-Sided|95.0|0.531|1.059|||Regression, Cox||||
1765063|NCT00086580|3240691|Superiority or Other||Cox Proportional Hazard|0.718||||0.021|2-Sided|95.0|0.543|0.951|||Regression, Cox|Cox proportional hazards model stratified by Rai Stage Group.|||
1765064|NCT00086580|3240693|Superiority or Other||Cox Proportional Hazard|0.562|||<|0.001|2-Sided|95.0|0.42|0.752|||Regression, Cox|Cox regression model stratified by Rai Stage Group.|||
1765065|NCT00086580|3240694|Superiority or Other||Cox Proportional Hazard|0.648||||0.042|2-Sided|95.0|0.449|0.937||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Regression, Cox|Cox proportional hazards model stratified by Rai Stage Group|||
1765497|NCT00083174|3241029|Superiority or Other (legacy)||Hazard Ratio (HR)|0.47||||0.004|2-Sided|95.0|0.27|0.79|||Log Rank||||
1765066|NCT00086580|3240695|Superiority or Other||Mean Difference (Final Values)|0.08||||0.018|2-Sided|95.0|0.02|0.15||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Cochran-Mantel-Haenszel|CMH chi-square test for a difference in complete response rates between treatments stratified by Rai Stage Group.|Difference and confidence interval (CI) calculated using the recommended method by Altman et al.|Comparison of complete response (CR).|
1765067|NCT00086580|3240695|Superiority or Other||Mean Difference (Final Values)|0.06||||0.178|2-Sided|95.0|-0.03|0.15||P-value presented is adjusted for multiple tests using Hochberg procedure for 3 clinically important secondary endpoints: ORR, CR rates and OS.|Cochran-Mantel-Haenszel|CMH chi-square test for a difference in overall response rates between treatments stratified by Rai Stage Group.|Difference and confidence interval (CI) calculated using the recommended method by Altman et al.|Comparison of Overall Response.|
1765068|NCT00086580|3240696|Superiority or Other||Hazard Ratio (HR)|0.61|||<|0.001|2-Sided|95.0|0.467|0.795|||Regression, Cox|Cox proportional hazards model was stratified by Rai Stage Group|||
1765069|NCT00086411|3240698|Superiority or Other||Odds Ratio (OR)|1.32|Standard Error of the Mean|0.2734|<|0.017|2-Sided|95.0|0.77|2.25||The p-value was adjusted for multiple comparisons.|GEE model for repeated binary outcomes|Model included hx of heavy smoking, elevated depression, cigarettes per day, gender, and race|The above was for the main effect of BUP versus NTX on cessation.|Rates of abstinence were addressed using a generalized estimating equations (GEE) logistic regression model. Counseling type and medication type were entered as the main explanatory variables along with time and the interaction of these factors, together with some covariates (described below). The sample size provided 80% power to detect a difference of about 14% between groups across three time points (i.e., 12, 26, and 52 weeks post-treatment initiation.|
1765070|NCT00086515|3240700|Superiority or Other||Mean Difference (Final Values)|-50.6|||<|0.001|2-Sided|95.0|-60.5|-40.8|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline 2-hour PMG|||
1765071|NCT00086515|3240701|Superiority or Other||Mean Difference (Final Values)|-25.4|||<|0.001|2-Sided|95.0|-31.0|-19.8|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline FPG|||
1765072|NCT00086515|3240702|Superiority or Other||Mean Difference (Final Values)|-0.65|||<|0.001|2-Sided|95.0|-0.77|-0.53|||ANCOVA|Model terms: treatment, prior AHA status (not on AHA, on monotherapy oral AHA, or on metformin-based oral combination AHA), and baseline A1C|||
1765073|NCT00086502|3240703|Superiority or Other||Mean Difference (Net)|-17.7|Standard Deviation|30.9|<|0.001||95.0|-24.3|-11.0||Model terms: treatment; baseline; prior antihyperglycemic agent (AHA) therapy [not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy]|ANCOVA||||
1765074|NCT00086502|3240704|Superiority or Other||Mean Difference (Net)|-0.7|Standard Deviation|0.73|<|0.001||95.0|-0.85|-0.54||"Model terms: treatment; baseline; prior antihyperglycemic~agent (AHA) therapy [not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy]"|ANCOVA||||
1765075|NCT00086450|3240705|Superiority or Other|||||||0.68|||||||Regression, Cox||||
1765076|NCT00086450|3240706|Superiority or Other||Hazard Ratio (HR)|5.4||||0.049||95.0|||||Log Rank||||
1765077|NCT00086450|3240707|Superiority or Other||Hazard Ratio (HR)|2.74||||0.004||95.0|1.91|3.89|||Regression, Cox||||
1765078|NCT00086450|3240708|Superiority or Other||Cox Proportional Hazard|7.9||||0.005||95.0|3.3|12.5|||Regression, Cox||||
1765079|NCT00086346|3240709|Non-Inferiority or Equivalence|The a priori criterion for declaring non-inferiority was a lower bound of the 95% confidence interval (CI) having a ≥ 5% difference in graft loss. -5.2 is < 5 % difference.|Mean Difference (Net)|-1.2||||||95.0|-5.2|2.8|||||Weighted difference in percentage of graft loss: (CNI% minus SRL%); negative values are favorable to CNI group||
1765080|NCT00086346|3240710|Superiority or Other||||||>|0.05|||||||1 way ANOVA, two sided||||
1765081|NCT00086346|3240711|Superiority or Other|||||||0.017|||||||Cochran-Mantel-Haenszel|||Comparison between treatment groups of percentages of patients with biopsy-confirmed acute rejection.|
1765082|NCT00086346|3240712|Superiority or Other|||||||0.342|||||||Rank ANCOVA||||
1765083|NCT00086281|3240713|Superiority or Other|||||||0.3132||||||Bonferroni adjusted P-Value|ANOVA on ranks||||
1765084|NCT00086281|3240713|Superiority or Other|||||||0.5055||||||Bonferroni adjusted P-Value|ANOVA on ranks||||
1765085|NCT00086281|3240713|Superiority or Other|||||||0.0119||||||Bonferroni adjusted P-Value|ANOVA on ranks||||
1765086|NCT00086281|3240713|Superiority or Other|||||||0.0244||||||Bonferroni adjusted P-Value|ANOVA on ranks||||
1765087|NCT00086281|3240713|Superiority or Other|||||||0.009|||||||ANOVA on ranks||||
1765088|NCT00086307|3240714|Superiority or Other||Mean Difference (Net)|3.473|Standard Error of the Mean|2.162||0.349|2-Sided|95.0|-1.942|8.888||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The pramipexole group had a lower MADRS score than the escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the escitalopram group.|
1765089|NCT00086307|3240714|Superiority or Other||Mean Difference (Net)|3.353|Standard Error of the Mean|2.296||0.454|2-Sided|95.0|-2.36|9.066||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The escitalopram group had a lower MADRS score than the pramipexole and escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the escitalopram group to the pramipexole and escitalopram combination group.|
1765090|NCT00086307|3240714|Superiority or Other||Mean Difference (Net)|6.826|Standard Error of the Mean|2.296||0.014|2-Sided|95.0|1.111|12.541||The significance level was adjusted using a Bonferroni correction.|Post hoc simple effects test||The pramipexole group had a lower MADRS score than the pramipexole and escitalopram group.|Post-hoc simple effects tests with Bonferroni correction were used to compare the pramipexole group to the pramipexole and escitalopram combination group.|
1765526|NCT00081458|3241109|Superiority or Other|||||||0.007|||||||ANCOVA||||
1765636|NCT00076999|3241478|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765637|NCT00076999|3241478|Superiority or Other|||||||0.01|||||||Fisher Exact|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765091|NCT00086307|3240714|Superiority or Other||Mean Difference (Net)|6.826|Standard Error of the Mean|2.296||0.018|2-Sided|95.0|1.111|12.541||This is the omnibus effect of drug.|Mixed Models Analysis|||A linear mixed model with restricted maximum likelihood estimation and a first order autoregressive covariance structure was used to examine depressive symptoms over time. Fixed factors for drug, time, and a time by drug interaction were included in the model along with the intercept. No random factors were included because the subject factor did not contribute significantly to the model. Baseline symptoms were used as a covariate.|
1765092|NCT00086138|3240732|Superiority or Other||Odds Ratio (OR)|2.06||||0.11|2-Sided|95.0|0.84|5.04|||Chi-squared||||
1765093|NCT00086138|3240733|Superiority or Other||Odds Ratio (OR)|1.01||||0.98|2-Sided|95.0|0.52|1.97|||Chi-squared|||The statistical analyses compared data collected from the CGIC of participants who received sertraline who had a score equal to or better than the CGIC of participants who received the placebo intervention.|
1765094|NCT00086047|3240736|Superiority or Other||Mean Difference (Final Values)|5.39|Standard Deviation|8.8||0.007|2-Sided|95.0|1.57|9.22|||Mixed Models Analysis||||
1765095|NCT00085735|3240762|Non-Inferiority|A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis comparing IFRT vs. PFRT, a one-sided 94% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by age group and RT group (LDCSI vs. SDCSI)). If the upper confidence limit is lower than 1.6, IFRT would be deemed to be non-inferior. If not, non-inferiority would not be established.|Hazard Ratio (HR)|1.0|||||1-Sided|94.0||1.3||||||The comparison is based on all eligible randomized patients 3-21 years of age without anaplastic histology or excess residual disease or disseminated disease by central review as per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed with power of 0.94 to detect a 10% reduction in cure rate and power of 0.65 to detect a 5% reduction in cure rate, due to the use of IFRT compared to PFRT.|
1765096|NCT00085735|3240762|Non-Inferiority|A hazard ratio of 1.6 is used as the non-inferiority margin. For the final analysis of comparing LDCSI vs. SDCSI, a one-sided 80% upper confidence limit of the hazard ratio based on a stratified approach will be estimated (stratified by RT group (IFRT vs. PFRT)). If the upper confidence limit is lower than 1.6, LDCSI would be deemed to be non-inferior. If not, non-inferiority would not be established.|Hazard Ratio (HR)|1.5|||||1-Sided|80.0||1.9||||||The comparison is based on all eligible randomized patients 3-7 years of age without anaplastic histology or excess residual disease or disseminated disease by central review per the protocol document. Using a one-sided log rank test with type I error of 0.20, this study was designed to have power of 0.80 to detect a 10% reduction in cure rate due to the use of LDCSI compared to SDCSI.|
1765097|NCT00085709|3240764|Superiority or Other||||||<|0.0025|||||||Test of difference of proportions|||Interim futility analysis alternative hypothesis based on the design specification that the 7+3+GO arm would have a 12% increase in CR rate.|
1765098|NCT00085709|3240765|Superiority or Other||||||<|0.001|||||||Regression, Cox|The interim analysis only reported a p-value for testing whether the hazard ratio was not equal to 1.5.||Interim futility analysis of the alternative hypothesis for disease-free survival. The design specified a hazard ratio of (observation: GO) of 1.5.|
1765099|NCT00085644|3240801|Superiority or Other||Mean Difference (Net)|0.0|Standard Error of the Mean|0.3||0.985||95.0|||||ANCOVA||||
1765100|NCT00085644|3240802|Superiority or Other||Risk Difference (RD)|37.6|||<|0.001||95.0|27.4|47.8|||Chi-squared||Risk difference is measured as a percentage.|ASAS 20 response rates of the adalimumab group were compared with the placebo group using Pearson's Chi-square test. The counts and percentages were calculated for total sample and by therapy group. Statistical tests were 2-sided. For the statistical analysis, subjects with missing data before Week 12 were considered as nonresponders. The comparisons were performed at an alpha level = 0.05.|
1765101|NCT00085254|3240834|Superiority or Other||Hazard Ratio (HR)|0.39||||0.0001|2-Sided|95.0|0.3|0.5||adjusted for age: p=.0003, kps: p=.004; and surgical procedure: p=.003|Log Rank|||Primary endpoint death - defined from histological diagnosis to death. we assume pt in the study will have overall failure rate of 0.56 per person-year of f/up, a 30% reduction compared to hazard rate of 0.8 per person-year in historical NABTT database. Expected hazard ratio is 0.7 and cohort will produce 63 events among total of 94 pt planned f/up. One-sided test, have 95% power to detect observed ratio of 0.7 at alpha level of 0.1, or we have 88% power at alpha of 0.5 statistical significant|
1765102|NCT00085254|3240836|Superiority or Other||Hazard Ratio (HR)|0.83||||0.4|2-Sided|95.0|0.5|1.3|||Regression, Cox||||
1765103|NCT00085202|3240843|Superiority or Other (legacy)|||||||0.0206|||||||Log Rank||||
1765104|NCT00085202|3240844|Superiority or Other (legacy)|||||||0.7696|||||||Log Rank||||
1765105|NCT00085202|3240844|Superiority or Other (legacy)|||||||0.5195|||||||Log Rank||||
1765106|NCT00085202|3240844|Superiority or Other (legacy)|||||||0.8001|||||||Log Rank||||
1765107|NCT00084318|3240908|Superiority or Other||Hazard Ratio (HR)|1.16||||0.86|2-Sided|95.0|0.72|1.87|||Gray's test|Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)|Reference arm = historical control|Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model.|
1765108|NCT00084318|3240908|Superiority or Other||Hazard Ratio (HR)|1.05||||0.66|2-Sided|95.0|0.63|1.76|||Gray's test|Historical control data (RTOG-9501/NCT00002670): n=202, two-year failure rate of 19.9% (12.2% to 27.5%)|Reference arm = historical control|Two-year failure rates were estimated by the cumulative incidence method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided Gray's test. Hazard ratios were estimated by Cox model. [RTOG = Radiation Therapy Oncology Group]|
1765109|NCT00084318|3240912|Superiority or Other||Hazard Ratio (HR)|0.56||||0.001|2-Sided|95.0|0.39|0.82|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).|Reference arm = historical control|Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model.|
1765550|NCT00079274|3241260|Superiority||Hazard Ratio (HR)|1.25||||0.15|2-Sided|95.0|0.92|1.68|||Regression, Cox|HR and p-value reported from a multivariate Cox PH regression model, adjusted for number of nodes, histologic grade, and T stage.|||
1765110|NCT00084318|3240912|Superiority or Other||Hazard Ratio (HR)|0.72||||0.04|2-Sided|95.0|0.5|1.03|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year survival rate of 64.7% (58.1% to 71.3%).|Reference arm = historical control|Two-year rates were estimated by the Kaplan-Meier method. RTOG 0234 results were compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) by 1-sided log-rank test. Hazard ratios were estimated by Cox model. [RTOG = Radiation Therapy Oncology Group]|
1765111|NCT00084318|3240913|Superiority or Other||Hazard Ratio (HR)|0.69||||0.01|2-Sided|95.0|0.5|0.96|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).||Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method.|
1765112|NCT00084318|3240913|Superiority or Other||Hazard Ratio (HR)|0.76||||0.05|2-Sided|95.0|0.54|1.06|||Log Rank|Historical control data (RTOG-9501/NCT00002670): n=202, two-year disease-free survival rate of 54.8% (47.9% to 61.7%).||Using the method of Dixon and Simon, 104 analyzable patients per arm were needed to detect a ≥ 33 reduction in the hazard rate for disease-free survival compared to historical control data (the chemoradiation arm of study RTOG-9501/NCT00002670) with 80% power and one-sided log-rank test at the 0.05 level. Two-year rates were estimated by the Kaplan-Meier method. [RTOG = Radiation Therapy Oncology Group]|
1765113|NCT00084266|3240914|Superiority or Other|||||||0.859|||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.|
1765114|NCT00084266|3240915|Superiority or Other|||||||0.5985|||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.|
1765115|NCT00084266|3240916|Superiority or Other|||||||0.9344|||||||Log Rank|||Statistical comparison of survival analysis was performed.Log rank method was used to calculate p-value.|
1765116|NCT00084266|3240928|Non-Inferiority or Equivalence|The final p-value was compared against an O'Brien-Fleming boundary of 0.048.||||||0.042|||||||Chi-squared|||"Chi-squared test was used to calculate p-value. P-value was calculated for participants with clinical outcome as cure."|
1765117|NCT00084136|3240952|Superiority or Other||Hazard Ratio (HR)|0.95|||||2-Sided|95.0|0.72|1.27|||||The HR is for TDF/FTC+EFV vs. ZDV/3TC+EFV.|While original study design specified a non-inferiority test, study follow-up stopped early, not due to treatment effect size or futility, but due to slowing accumulation of primary outcome events. Therefore, 2-sided, 95% confidence intervals about the estimated treatment effect (relative effect estimated by a hazard ratio) are provided.|
1765118|NCT00084136|3240953|Superiority or Other||Hazard Ratio (HR)|1.51|||<|0.01|2-Sided|95.0|1.12|2.04||Not adjusted for multiple interim analyses. Peto-Haybittle spending function was used as a basis for calculating the repeated confidence intervals used in interim monitoring.|Log Rank|Log-rank test was stratified by country and screening RNA (< 100,000 c/mL vs >= 100,000 copies/mL).|The HR is for ddI+FTC+ATV vs. ZDV/3TC+EFV.||
1765119|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|8.279||||0.0201||95.0|1.297|15.261|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765120|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|8.14||||0.0182||95.0|1.384|14.896|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765121|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|8.063||||0.0172||95.0|1.432|14.693|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765122|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|7.924||||0.0153||95.0|1.518|14.329|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765123|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|7.846||||0.0144||95.0|1.565|14.127|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765124|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|7.707||||0.0126||95.0|1.65|13.764|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765125|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|7.63||||0.0117||95.0|1.697|13.562|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765126|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|7.491||||0.0101||95.0|1.78|13.201|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765551|NCT00079040|3241275|Superiority or Other||Percentage|63.5|||||2-Sided|90.0|52.4|73.6|||||||
1765127|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|7.413||||0.0093||95.0|1.826|13.0|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765128|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|7.274||||0.0079||95.0|1.908|12.64|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765129|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|7.197||||0.0072||95.0|1.953|12.441|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765130|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|7.057||||0.0059||95.0|2.032|12.083|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765131|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|6.98||||0.0053||95.0|2.076|11.884|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765132|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|6.841||||0.0042||95.0|2.153|11.529|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765133|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|6.764||||0.0037||95.0|2.195|11.332|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765134|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|6.624||||0.0029||95.0|2.269|10.98|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765135|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|6.547||||0.0025||95.0|2.309|10.785|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765136|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|6.408||||0.0018||95.0|2.379|10.436|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765137|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|6.331||||0.0015||95.0|2.417|10.244|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765138|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|6.191||||0.0011||95.0|2.482|9.9|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765139|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|6.114||||0.0009||95.0|2.517|9.711|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765140|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|5.975||||0.0006||95.0|2.576|9.374|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765141|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|5.898||||0.0004||95.0|2.607|9.188|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765142|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|5.758||||0.0003||95.0|2.657|8.859|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765143|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|5.681||||0.0002||95.0|2.683|8.679|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765144|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|5.542||||0.0001||95.0|2.723|8.361|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765145|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|5.464|||<|0.0001||95.0|2.741|8.188|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765146|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|5.325|||<|0.0001||95.0|2.767|7.884|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765147|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|5.248|||<|0.0001||95.0|2.776|7.72|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765148|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|5.109|||<|0.0001||95.0|2.783|7.435|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765149|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|5.031|||<|0.0001||95.0|2.78|7.283|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765150|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|4.892|||<|0.0001||95.0|2.76|7.024|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765151|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|4.815|||<|0.0001||95.0|2.741|6.889|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765152|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|4.676|||<|0.0001||95.0|2.689|6.662|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765153|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|4.598|||<|0.0001||95.0|2.65|6.547|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765154|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|4.459|||<|0.0001||95.0|2.558|6.361|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765155|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|4.382|||<|0.0001||95.0|2.494|6.269|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765156|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|4.243|||<|0.0001||95.0|2.358|6.128|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765157|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|4.165|||<|0.0001||95.0|2.269|6.061|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—VAS baseline score (intercept and time since randomization are included as random effects)|
1765158|NCT00083889|3240965|Superiority or Other||Mean Difference (Final Values)|4.026|||<|0.0001|2-Sided|95.0|2.088|5.965|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline Euro-QoL Visual Analog Scale (EQ—VAS) baseline score (intercept and time since randomization are included as random effects).|
1765159|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.02||||0.6424||95.0|-0.063|0.102|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765160|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.021||||0.6141||95.0|-0.059|0.1|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765161|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.021||||0.5979||95.0|-0.057|0.099|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765162|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.022||||0.5675||95.0|-0.054|0.098|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765163|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.023||||0.5501||95.0|-0.051|0.097|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765164|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.024||||0.5176||95.0|-0.048|0.095|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765165|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.024||||0.499||95.0|-0.046|0.094|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765166|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.025||||0.4646||95.0|-0.042|0.092|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765167|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.026||||0.4449||95.0|-0.04|0.091|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765168|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.027||||0.4086||95.0|-0.036|0.09|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765169|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.027||||0.3881||95.0|-0.034|0.089|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765170|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.028||||0.3504||95.0|-0.031|0.087|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765171|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.029||||0.3293||95.0|-0.029|0.086|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765172|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.03||||0.291||95.0|-0.025|0.085|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765173|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.03||||0.2698||95.0|-0.023|0.084|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765174|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.031||||0.2319||95.0|-0.02|0.082|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765175|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.032||||0.2112||95.0|-0.018|0.081|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765176|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.033||||0.1752||95.0|-0.015|0.08|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765177|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.033||||0.1561||95.0|-0.013|0.079|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765178|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.034||||0.1237||95.0|-0.009|0.078|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765179|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.035||||0.107||95.0|-0.007|0.077|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765180|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.036||||0.08||95.0|-0.004|0.076|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765181|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.036||||0.0667||95.0|-0.002|0.075|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765182|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.037||||0.0464||95.0|0.001|0.074|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765183|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.038||||0.037||95.0|0.002|0.073|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765184|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.039||||0.0236||95.0|0.005|0.072|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765185|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.039||||0.0179||95.0|0.007|0.072|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765186|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.04||||0.0105||95.0|0.009|0.071|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765187|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.041||||0.0076||95.0|0.011|0.071|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765188|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.042||||0.0041||95.0|0.013|0.07|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765189|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.042||||0.0029||95.0|0.014|0.07|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765190|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.043||||0.0016||95.0|0.016|0.07|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765191|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.044||||0.0011||95.0|0.017|0.07|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765192|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.045||||0.0007||95.0|0.019|0.07|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765193|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.045||||0.0005||95.0|0.02|0.071|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765194|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.046||||0.0004||95.0|0.021|0.072|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765195|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.047||||0.0003||95.0|0.021|0.072|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765196|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.048||||0.0003||95.0|0.022|0.074|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765197|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.048||||0.0003||95.0|0.022|0.075|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EQ—5D Health state index baseline score (intercept and time since randomization are included as random effects)|
1765198|NCT00083889|3240966|Superiority or Other||Mean Difference (Final Values)|0.049||||0.0004|2-Sided|95.0|0.022|0.076|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline EuroQoL Five Dimension (EQ-5D): Health state index baseline score (intercept and time since randomization are included as random effects).|
1765199|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.714||||0.0208||95.0|0.413|5.015|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765200|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.687||||0.0179||95.0|0.462|4.912|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765201|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.672||||0.0164||95.0|0.49|4.855|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765202|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.645||||0.0138||95.0|0.539|4.752|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765203|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.631||||0.0125||95.0|0.567|4.695|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765204|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.604||||0.0103||95.0|0.616|4.592|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765205|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.589||||0.0091||95.0|0.643|4.535|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765552|NCT00079001|3241278|Superiority or Other (legacy)||Hazard Ratio (HR)|0.89||||0.22|2-Sided|95.0|0.74|1.07|||Log Rank|Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.|Zoledronic acid versus placebo group||
1765904|NCT00070707|3241999|Superiority or Other|Change at Final Week (PM)||||||0.527|||||||ANOVA||||
1765206|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.562||||0.0073||95.0|0.691|4.433|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765207|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.547||||0.0064||95.0|0.718|4.377|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765208|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.521||||0.0049||95.0|0.766|4.275|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765209|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.506||||0.0042||95.0|0.792|4.219|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765210|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.479||||0.003||95.0|0.84|4.119|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765211|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.464||||0.0025||95.0|0.866|4.063|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765212|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.438||||0.0017||95.0|0.912|3.963|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765213|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.423||||0.0014||95.0|0.938|3.908|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765214|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.396||||0.0009||95.0|0.983|3.809|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765215|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.381||||0.0007||95.0|1.008|3.754|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765216|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.354||||0.0004||95.0|1.052|3.657|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765217|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.34||||0.0003||95.0|1.076|3.603|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765218|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.313||||0.0001||95.0|1.119|3.507|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765219|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.298|||<|0.0001||95.0|1.142|3.454|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765220|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.271|||<|0.0001||95.0|1.182|3.361|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765553|NCT00079001|3241279|Superiority or Other (legacy)||Hazard Ratio (HR)|0.88||||0.29|2-Sided|95.0|0.7|1.12|||Log Rank|Adjusted for stratification factors: performance status, prior SRE, and serum alkaline phosphatase.|Zoledronic acid versus placebo group||
1765221|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.256|||<|0.0001||95.0|1.203|3.309|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765222|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.23|||<|0.0001||95.0|1.241|3.219|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765223|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.215|||<|0.0001||95.0|1.26|3.169|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765224|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.188|||<|0.0001||95.0|1.294|3.082|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765225|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.173|||<|0.0001||95.0|1.311|3.036|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765226|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.146|||<|0.0001||95.0|1.339|2.954|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765227|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.132|||<|0.0001||95.0|1.353|2.91|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765228|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.105|||<|0.0001||95.0|1.374|2.836|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765229|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.09|||<|0.0001||95.0|1.383|2.797|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765230|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.063|||<|0.0001||95.0|1.394|2.732|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765231|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.048|||<|0.0001||95.0|1.397|2.7|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765232|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.022|||<|0.0001||95.0|1.396|2.647|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765233|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|2.007|||<|0.0001||95.0|1.392|2.622|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765234|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|1.98|||<|0.0001||95.0|1.376|2.584|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765235|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|1.965|||<|0.0001||95.0|1.363|2.568|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765577|NCT00078559|3241333|Superiority or Other||Proportion with acute rejection|0.0|||||2-Sided|95.0|0.0|0.3|||||||
1765578|NCT00078559|3241334|Superiority or Other||Proportion with acute rejection|0.1|||||2-Sided|95.0|0.01|0.34|||||||
1765579|NCT00002597|3241335|Superiority||||||<|0.001|||||||Chi-squared||||
1765236|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|1.939|||<|0.0001||95.0|1.331|2.546|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765237|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|1.924|||<|0.0001||95.0|1.309|2.539|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G FWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765238|NCT00083889|3240967|Superiority or Other||Mean Difference (Final Values)|1.897|||<|0.0001|2-Sided|95.0|1.261|2.533|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Functional Well Being (FWB) subscale baseline score (intercept and time since randomization are included as random effects).|
1765239|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.708||||0.3827||95.0|-0.882|2.298|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765240|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.715||||0.3616||95.0|-0.822|2.252|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765241|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.719||||0.3497||95.0|-0.788|2.227|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765242|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.726||||0.3276||95.0|-0.728|2.181|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765243|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.73||||0.3152||95.0|-0.695|2.156|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765244|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.738||||0.2923||95.0|-0.635|2.111|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765245|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.742||||0.2794||95.0|-0.602|2.086|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765246|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.749||||0.2559||95.0|-0.543|2.041|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765247|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.753||||0.2427||95.0|-0.51|2.016|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765248|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.76||||0.2188||95.0|-0.452|1.972|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765249|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.764||||0.2055||95.0|-0.419|1.948|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765250|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.771||||0.1817||95.0|-0.361|1.904|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765580|NCT00002597|3241336|Superiority||Hazard Ratio (HR)|1.38|||<|0.001|2-Sided|95.0|1.22|1.56|||Log Rank||Reference level = Hormone Therapy + Radiation Therapy|Treatment arms were compared using the log-rank test (one-sided significance level of 0.025).|
1765905|NCT00070707|3241999|Superiority or Other|Change at Week 4 (PM)||||||0.616|||||||ANOVA||||
1765251|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.776||||0.1686||95.0|-0.329|1.88|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765252|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.783||||0.1454||95.0|-0.271|1.836|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765253|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.787||||0.1328||95.0|-0.239|1.813|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765254|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.794||||0.111||95.0|-0.182|1.77|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765255|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.798||||0.0994||95.0|-0.151|1.747|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765256|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.805||||0.0797||95.0|-0.095|1.706|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765257|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.809||||0.0696||95.0|-0.065|1.683|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765258|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.817||||0.0529||95.0|-0.01|1.643|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765259|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.821||||0.0447||95.0|0.019|1.622|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765260|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.828||||0.0318||95.0|0.072|1.583|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765261|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.832||||0.0257||95.0|0.101|1.563|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765262|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.839||||0.0168||95.0|0.151|1.527|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765263|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.843||||0.0129||95.0|0.179|1.508|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765264|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.85||||0.0076||95.0|0.226|1.475|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765265|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.854||||0.0055||95.0|0.251|1.457|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765266|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.862||||0.0029||95.0|0.295|1.428|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765267|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.866||||0.002||95.0|0.318|1.414|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765268|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.873||||0.0009||95.0|0.356|1.39|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765269|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.877||||0.0006||95.0|0.375|1.379|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765270|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.884||||0.0003||95.0|0.406|1.362|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765271|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.888||||0.0002||95.0|0.421|1.355|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765272|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.895||||0.0001||95.0|0.444|1.347|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765273|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.899|||<|0.0001||95.0|0.453|1.345|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765274|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.907|||<|0.0001||95.0|0.466|1.348|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765275|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.911|||<|0.0001||95.0|0.469|1.352|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765276|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.918|||<|0.0001||95.0|0.471|1.365|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765277|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.922|||<|0.0001||95.0|0.469|1.375|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G EWB subscale baseline score (intercept and time since randomization are included as random effects)|
1765278|NCT00083889|3240968|Superiority or Other||Mean Difference (Final Values)|0.929|||<|0.0001|2-Sided|95.0|0.46|1.398|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Emotional Well Being (EWB) subscale baseline score (intercept and time since randomization are included as random effects).|
1765279|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.291||||0.1466|2-Sided|95.0|-0.452|3.034|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765280|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.288||||0.1346|2-Sided|95.0|-0.399|2.976|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765281|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.287||||0.128|2-Sided|95.0|-0.37|2.944|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765638|NCT00076999|3241479|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765639|NCT00076999|3241479|Superiority or Other|||||||0.12|||||||Fisher Exact|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765282|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.284||||0.1161|2-Sided|95.0|-0.318|2.886|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765283|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.283||||0.1095|2-Sided|95.0|-0.288|2.854|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765284|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.28||||0.098|2-Sided|95.0|-0.236|2.797|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765285|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.279||||0.0917|2-Sided|95.0|-0.207|2.765|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765286|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.276||||0.0806|2-Sided|95.0|-0.155|2.708|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765287|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.275||||0.0746|2-Sided|95.0|-0.127|2.677|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765288|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.273||||0.0642|2-Sided|95.0|-0.075|2.62|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765289|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.271||||0.0587|2-Sided|95.0|-0.047|2.589|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765290|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.269||||0.0493|2-Sided|95.0|0.004|2.533|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765291|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.267||||0.0443|2-Sided|95.0|0.032|2.502|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765292|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.265||||0.036|2-Sided|95.0|0.083|2.447|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765293|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.263||||0.0318|2-Sided|95.0|0.11|2.416|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765294|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.261||||0.0248|2-Sided|95.0|0.16|2.362|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765295|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.259||||0.0213|2-Sided|95.0|0.187|2.332|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765296|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.257||||0.0159|2-Sided|95.0|0.236|2.278|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765640|NCT00076999|3241480|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765906|NCT00070707|3241999|Superiority or Other|Change at Week 3 (PM)||||||0.149|||||||ANOVA||||
1765297|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.255||||0.0132|2-Sided|95.0|0.262|2.248|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765298|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.253||||0.0092|2-Sided|95.0|0.31|2.196|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765299|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.251||||0.0074|2-Sided|95.0|0.336|2.167|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765300|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.249||||0.0048|2-Sided|95.0|0.382|2.116|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765301|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.248||||0.0037|2-Sided|95.0|0.406|2.089|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765302|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.245||||0.0021|2-Sided|95.0|0.45|2.04|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765303|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.244||||0.0015|2-Sided|95.0|0.474|2.013|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765304|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.241||||0.0008|2-Sided|95.0|0.515|1.967|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765305|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.24||||0.0005|2-Sided|95.0|0.537|1.942|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765306|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.237||||0.0003|2-Sided|95.0|0.575|1.899|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765307|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.236||||0.0002|2-Sided|95.0|0.595|1.876|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765308|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.233|||<|0.0001|2-Sided|95.0|0.629|1.838|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765309|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.232|||<|0.0001|2-Sided|95.0|0.646|1.818|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765310|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.229|||<|0.0001|2-Sided|95.0|0.673|1.785|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765311|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.228|||<|0.0001|2-Sided|95.0|0.687|1.769|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765641|NCT00076999|3241480|Superiority or Other|||||||0.12|||||||Fisher Exact|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765642|NCT00076999|3241481|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765312|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.225|||<|0.0001|2-Sided|95.0|0.707|1.744|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765313|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.224|||<|0.0001|2-Sided|95.0|0.716|1.732|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765314|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.221|||<|0.0001|2-Sided|95.0|0.727|1.716|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765315|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.22|||<|0.0001|2-Sided|95.0|0.73|1.71|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765316|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.217|||<|0.0001|2-Sided|95.0|0.731|1.704|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765317|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.216|||<|0.0001|2-Sided|95.0|0.729|1.703|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G SWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765318|NCT00083889|3240969|Superiority or Other||Mean Difference (Final Values)|1.214|||<|0.0001|2-Sided|95.0|0.719|1.708|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Social/Family Well Being (SWB) subscale baseline score (intercept and time since randomization are included as random effects).|
1765319|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.271||||0.2283|2-Sided|95.0|-0.797|3.338|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765320|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.277||||0.21|2-Sided|95.0|-0.72|3.273|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765321|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.28||||0.1998|2-Sided|95.0|-0.677|3.238|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765322|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.287||||0.1813|2-Sided|95.0|-0.6|3.173|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765323|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.29||||0.1711|2-Sided|95.0|-0.558|3.138|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765324|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.296||||0.1529|2-Sided|95.0|-0.481|3.074|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765325|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.3||||0.1429|2-Sided|95.0|-0.439|3.038|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765326|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.306||||0.1252|2-Sided|95.0|-0.363|2.975|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765643|NCT00076999|3241481|Superiority or Other|||||||0|||||||Fisher Exact|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765327|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.309||||0.1156|2-Sided|95.0|-0.321|2.94|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765328|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.315||||0.0988|2-Sided|95.0|-0.246|2.877|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765329|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.319||||0.0898|2-Sided|95.0|-0.205|2.842|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765330|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.325||||0.0744|2-Sided|95.0|-0.131|2.78|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765331|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.328||||0.0663|2-Sided|95.0|-0.09|2.746|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765332|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.335||||0.0528|2-Sided|95.0|-0.016|2.685|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT—G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765333|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.338||||0.0459|2-Sided|95.0|0.024|2.652|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765334|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.344||||0.0348|2-Sided|95.0|0.096|2.592|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765335|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.348||||0.0293|2-Sided|95.0|0.136|2.559|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765336|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.354||||0.0208|2-Sided|95.0|0.206|2.501|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765337|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.357||||0.0168|2-Sided|95.0|0.245|2.47|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765338|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.363||||0.011|2-Sided|95.0|0.313|2.414|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765339|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.367||||0.0084|2-Sided|95.0|0.35|2.383|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765340|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.373||||0.0049|2-Sided|95.0|0.416|2.33|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765341|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.376||||0.0035|2-Sided|95.0|0.451|2.301|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765644|NCT00076999|3241482|Superiority or Other|||||||0.78|||||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765907|NCT00070707|3241999|Superiority or Other|Change at Week 2 (PM)||||||0.476|||||||ANOVA||||
1765342|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.383||||0.0018|2-Sided|95.0|0.514|2.252|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765343|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.386||||0.0012|2-Sided|95.0|0.547|2.225|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765344|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.392||||0.0005|2-Sided|95.0|0.604|2.18|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765345|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.396||||0.0003|2-Sided|95.0|0.634|2.157|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765346|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.402||||0.0001|2-Sided|95.0|0.685|2.119|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765347|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.405|||<|0.0001|2-Sided|95.0|0.711|2.099|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765348|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.411|||<|0.0001|2-Sided|95.0|0.753|2.069|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765349|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.415|||<|0.0001|2-Sided|95.0|0.774|2.056|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765350|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.421|||<|0.0001|2-Sided|95.0|0.805|2.037|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765351|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.424|||<|0.0001|2-Sided|95.0|0.819|2.029|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765352|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.431|||<|0.0001|2-Sided|95.0|0.838|2.023|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765353|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.434|||<|0.0001|2-Sided|95.0|0.844|2.024|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765354|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.44|||<|0.0001|2-Sided|95.0|0.848|2.032|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765355|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.444|||<|0.0001|2-Sided|95.0|0.847|2.041|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765356|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.45|||<|0.0001|2-Sided|95.0|0.837|2.063|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765645|NCT00076999|3241482|Superiority or Other|||||||0.02|||||||Fisher Exact|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765908|NCT00070707|3241999|Superiority or Other|Change at Week 1 (PM)||||||0.993|||||||ANOVA||||
1765357|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.453|||<|0.0001|2-Sided|95.0|0.827|2.079|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G PWB subscale baseline score (intercept and time since randomization are included as random effects).|
1765358|NCT00083889|3240970|Superiority or Other||Mean Difference (Final Values)|1.459|||<|0.0001|2-Sided|95.0|0.805|2.114|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) Physical Well Being (PWB) subscale baseline score (intercept and time since randomization are included as random effects).|
1765359|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.989||||0.0244|2-Sided|95.0|0.904|13.074|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765360|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.94||||0.0208|2-Sided|95.0|1.057|12.822|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765361|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.912||||0.0189|2-Sided|95.0|1.142|12.683|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765362|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.863||||0.0157|2-Sided|95.0|1.294|12.432|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765363|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.836||||0.0141|2-Sided|95.0|1.378|12.293|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765364|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.787||||0.0114|2-Sided|95.0|1.53|12.043|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765365|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.759||||0.01|2-Sided|95.0|1.613|11.905|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765366|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.71||||0.0079|2-Sided|95.0|1.764|11.657|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765367|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.683||||0.0068|2-Sided|95.0|1.847|11.519|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765368|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.634||||0.0051|2-Sided|95.0|1.995|11.272|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765369|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.606||||0.0043|2-Sided|95.0|2.077|11.135|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765370|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.557||||0.003|2-Sided|95.0|2.224|10.889|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765371|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.53||||0.0025|2-Sided|95.0|2.306|10.754|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765581|NCT00002597|3241337|Superiority||Hazard Ratio (HR)|2.06|||<|0.001|2-Sided|95.0|1.34|3.16|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.|
1765372|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.48||||0.0016|2-Sided|95.0|2.451|10.51|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765373|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.453||||0.0013|2-Sided|95.0|2.53|10.376|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765374|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.404||||0.0008|2-Sided|95.0|2.673|10.135|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765375|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.377||||0.0006|2-Sided|95.0|2.751|10.002|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765376|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.327||||0.0003|2-Sided|95.0|2.89|9.765|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765377|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.3||||0.0002|2-Sided|95.0|2.966|9.634|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765378|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.251||||0.0001|2-Sided|95.0|3.101|9.401|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765379|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.224|||<|0.0001|2-Sided|95.0|3.174|9.273|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765380|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.174|||<|0.0001|2-Sided|95.0|3.303|9.045|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765381|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.147|||<|0.0001|2-Sided|95.0|3.373|8.921|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765382|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.098|||<|0.0001|2-Sided|95.0|3.495|8.701|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765383|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.071|||<|0.0001|2-Sided|95.0|3.56|8.581|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765384|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|6.021|||<|0.0001|2-Sided|95.0|3.672|8.37|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765385|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.994|||<|0.0001|2-Sided|95.0|3.731|8.257|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765386|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.945|||<|0.0001|2-Sided|95.0|3.83|8.06|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765387|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.917|||<|0.0001|2-Sided|95.0|3.88|7.955|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765388|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.868|||<|0.0001|2-Sided|95.0|3.96|7.777|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765389|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.841|||<|0.0001|2-Sided|95.0|3.998|7.684|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765390|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.792|||<|0.0001|2-Sided|95.0|4.053|7.531|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765391|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.764|||<|0.0001|2-Sided|95.0|4.075|7.454|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765392|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.715|||<|0.0001|2-Sided|95.0|4.098|7.333|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765393|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.688|||<|0.0001|2-Sided|95.0|4.1|7.276|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765394|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.639|||<|0.0001|2-Sided|95.0|4.083|7.195|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765395|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.611|||<|0.0001|2-Sided|95.0|4.061|7.162|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765396|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.562|||<|0.0001|2-Sided|95.0|4.0|7.124|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765397|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.535|||<|0.0001|2-Sided|95.0|3.955|7.115|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-G baseline score (intercept and time since randomization are included as random effects).|
1765398|NCT00083889|3240971|Superiority or Other||Mean Difference (Final Values)|5.486|||<|0.0001|2-Sided|95.0|3.852|7.119|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline Functional Assessment of Cancer Therapy-General (FACT-G) baseline score (intercept and time since randomization are included as random effects).|
1765399|NCT00083889|3240972|Superiority or Other||Hazard Ratio (HR)|0.5418|||<|1e-05|2-Sided|95.0|0.4536|0.6473||p-value is from 2-sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN—a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN—α).|
1765400|NCT00083889|3240972|Superiority or Other||Hazard Ratio (HR)|0.5404|||<|0.0001|2-Sided|95.0|0.4532|0.6444||p-value is from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN—a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN—α).|
1765401|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|4.404||||0.0133|2-Sided|95.0|0.918|7.89|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765402|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|4.364||||0.0111|2-Sided|95.0|0.997|7.73|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765646|NCT00003222|3241483|Superiority or Other|||||||0.004|||||||Chi-squared|||This is a test for differences between the response rates of the two arms. The null hypothesis is that the arms have equal response rates and the alternative hypothesis is that they are different.|
1765403|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|4.341||||0.0099|2-Sided|95.0|1.041|7.642|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765404|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|4.3||||0.0081|2-Sided|95.0|1.119|7.482|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765405|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|4.278||||0.0071|2-Sided|95.0|1.162|7.394|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765406|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|4.237||||0.0056|2-Sided|95.0|1.24|7.235|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765407|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|4.215||||0.0048|2-Sided|95.0|1.283|7.147|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765408|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|4.174||||0.0037||95.0|1.36|6.988|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765409|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|4.152||||0.0031|2-Sided|95.0|1.403|6.901|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765410|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|4.111||||0.0022|2-Sided|95.0|1.479|6.743|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765411|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|4.089||||0.0018|2-Sided|95.0|1.521|6.656|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765412|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|4.048||||0.0012|2-Sided|95.0|1.597|6.5|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765413|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|4.026||||0.001|2-Sided|95.0|1.638|6.413|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765414|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.985||||0.0006||95.0|1.712|6.258|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765415|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.962||||0.0004|2-Sided|95.0|1.753|6.172|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765416|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.922||||0.0002|2-Sided|95.0|1.826|6.018|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765417|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.899||||0.0002|2-Sided|95.0|1.866|5.933|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765418|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.859|||<|0.0001|2-Sided|95.0|1.936|5.781|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765419|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.836|||<|0.0001|2-Sided|95.0|1.975|5.698|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765420|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.796|||<|0.0001|2-Sided|95.0|2.043|5.548|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765421|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.773|||<|0.0001|2-Sided|95.0|2.08|5.466|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765422|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.733|||<|0.0001|2-Sided|95.0|2.145|5.32|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765423|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.71|||<|0.0001|2-Sided|95.0|2.18|5.24|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765424|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.669|||<|0.0001|2-Sided|95.0|2.24|5.099|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765425|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.647|||<|0.0001|2-Sided|95.0|2.272|5.022|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765426|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.606|||<|0.0001|2-Sided|95.0|2.326|4.887|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765427|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.584|||<|0.0001||95.0|2.354|4.814|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)|
1765428|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.543|||<|0.0001|2-Sided|95.0|2.399|4.687|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765429|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.521|||<|0.0001|2-Sided|95.0|2.422|4.62|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765430|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.48|||<|0.0001|2-Sided|95.0|2.455|4.505|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765431|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.458|||<|0.0001|2-Sided|95.0|2.469|4.446|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765432|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.417|||<|0.0001|2-Sided|95.0|2.486|4.348|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765433|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.395|||<|0.0001|2-Sided|95.0|2.489|4.3|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765434|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.354|||<|0.0001||95.0|2.484|4.224|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765435|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.331|||<|0.0001|2-Sided|95.0|2.474|4.189|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765436|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.291|||<|0.0001|2-Sided|95.0|2.443|4.139|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765437|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.268|||<|0.0001|2-Sided|95.0|2.418|4.119|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765438|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.228|||<|0.0001|2-Sided|95.0|2.358|4.097|||Mixed Models Analysis|||Cycle 2 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects)|
1765439|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.205|||<|0.0001|2-Sided|95.0|2.318|4.092|||Mixed Models Analysis|||Cycle 1 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765440|NCT00083889|3240973|Superiority or Other||Mean Difference (Final Values)|3.165|||<|0.0001|2-Sided|95.0|2.234|4.095|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index (FKSI) baseline score (intercept and time since randomization are included as random effects).|
1765441|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.602||||0.0071|2-Sided|95.0|0.706|4.497|||Mixed Models Analysis|||Cycle 20 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765442|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.579||||0.0058|2-Sided|95.0|0.748|4.41|||Mixed Models Analysis|||Cycle 20 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765443|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.566||||0.0051|2-Sided|95.0|0.772|4.361|||Mixed Models Analysis|||Cycle 19 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765444|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.544||||0.004|2-Sided|95.0|0.813|4.274|||Mixed Models Analysis|||Cycle 19 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765445|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.531||||0.0034|2-Sided|95.0|0.836|4.226|||Mixed Models Analysis|||Cycle 18 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765446|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.509||||0.0026|2-Sided|95.0|0.878|4.14|||Mixed Models Analysis|||Cycle 18 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765447|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.496||||0.0022|2-Sided|95.0|0.901|4.092|||Mixed Models Analysis|||Cycle 17 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765909|NCT00070707|3241999|Superiority or Other|Baseline (PM)||||||0.851|||||||ANOVA||||
1765910|NCT00070707|3241999|Superiority or Other|Change at Final Week (AM)||||||0.355|||||||ANOVA||||
1765448|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.474||||0.0016|2-Sided|95.0|0.942|4.006|||Mixed Models Analysis|||Cycle 17 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765449|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.461||||0.0013|2-Sided|95.0|0.964|3.958|||Mixed Models Analysis|||Cycle 16 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765450|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.439||||0.0009||95.0|1.005|3.872|||Mixed Models Analysis|||Cycle 16 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765451|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.426||||0.0007|2-Sided|95.0|1.027|3.825|||Mixed Models Analysis|||Cycle 15 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765452|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.404||||0.0004|2-Sided|95.0|1.067|3.74|||Mixed Models Analysis|||Cycle 15 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765453|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.391||||0.0003|2-Sided|95.0|1.089|3.693|||Mixed Models Analysis|||Cycle 14 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765454|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.369||||0.0002|2-Sided|95.0|1.128|3.609|||Mixed Models Analysis|||Cycle 14 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765455|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.356||||0.0001|2-Sided|95.0|1.15|3.562|||Mixed Models Analysis|||Cycle 13 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765456|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.333|||<|0.0001|2-Sided|95.0|1.188|3.479|||Mixed Models Analysis|||Cycle 13 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765457|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.321|||<|0.0001|2-Sided|95.0|1.209|3.433|||Mixed Models Analysis|||Cycle 12 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765458|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.298|||<|0.0001|2-Sided|95.0|1.246|3.351|||Mixed Models Analysis|||Cycle 12 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765459|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.286|||<|0.0001|2-Sided|95.0|1.266|3.305|||Mixed Models Analysis|||Cycle 11 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765460|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.263|||<|0.0001|2-Sided|95.0|1.302|3.225|||Mixed Models Analysis|||Cycle 11 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765461|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.251|||<|0.0001|2-Sided|95.0|1.321|3.18|||Mixed Models Analysis|||Cycle 10 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765462|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.228|||<|0.0001|2-Sided|95.0|1.355|3.102|||Mixed Models Analysis|||Cycle 10 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765582|NCT00002597|3241338|Superiority||Hazard Ratio (HR)|1.5|||<|0.001|2-Sided|95.0|1.21|1.85|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.|
1765463|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.216|||<|0.0001|2-Sided|95.0|1.373|3.059|||Mixed Models Analysis|||Cycle 9 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765464|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.193|||<|0.0001|2-Sided|95.0|1.404|2.983|||Mixed Models Analysis|||Cycle 9 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765465|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.181|||<|0.0001|2-Sided|95.0|1.42|2.941|||Mixed Models Analysis|||Cycle 8 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765466|NCT00083889|3240974|Superiority or Other||Median Difference (Final Values)|2.158|||<|0.0001|2-Sided|95.0|1.447|2.869|||Mixed Models Analysis|||Cycle 8 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765467|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.146|||<|0.0001|2-Sided|95.0|1.461|2.83|||Mixed Models Analysis|||Cycle 7 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765468|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.123|||<|0.0001|2-Sided|95.0|1.483|2.763|||Mixed Models Analysis|||Cycle 7 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765469|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.11|||<|0.0001|2-Sided|95.0|1.494|2.727|||Mixed Models Analysis|||Cycle 6 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765470|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.088|||<|0.0001|2-Sided|95.0|1.509|2.667|||Mixed Models Analysis|||Cycle 6 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765471|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.075|||<|0.0001|2-Sided|95.0|1.515|2.635|||Mixed Models Analysis|||Cycle 5 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765472|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.053|||<|0.0001|2-Sided|95.0|1.522|2.584|||Mixed Models Analysis|||Cycle 5 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765473|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.04|||<|0.0001|2-Sided|95.0|1.522|2.559|||Mixed Models Analysis|||Cycle 4 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765474|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.018|||<|0.0001|2-Sided|95.0|1.517|2.519|||Mixed Models Analysis|||Cycle 4 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765475|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|2.005|||<|0.0001|2-Sided|95.0|1.51|2.501|||Mixed Models Analysis|||Cycle 3 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765476|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|1.983|||<|0.0001|2-Sided|95.0|1.491|2.475|||Mixed Models Analysis|||Cycle 3 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765477|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|1.97|||<|0.0001|2-Sided|95.0|1.476|2.464|||Mixed Models Analysis|||Cycle 2 Day 28: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765583|NCT00002597|3241339|Superiority||Hazard Ratio (HR)|1.74|||<|0.001|2-Sided|95.0|1.48|2.04|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.|
1765478|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|1.948|||<|0.0001|2-Sided|95.0|1.443|2.452|||Mixed Models Analysis|||Cycle 2 Day 1: Difference in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765479|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|1.935|||<|0.0001|2-Sided|95.0|1.421|2.449|||Mixed Models Analysis|||Cycle 1 Day 28: Difference in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FKSI—DRS baseline score (intercept and time since randomization are included as random effects).|
1765480|NCT00083889|3240974|Superiority or Other||Mean Difference (Final Values)|1.913|||<|0.0001|2-Sided|95.0|1.376|2.45|||Mixed Models Analysis|||Cycle 1 Day 1: Differences in effect estimates between treatment arms. Repeated measures mixed—effects model with an intercept term, treatment, time since randomization, treatment—by—time interaction, and baseline FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI—DRS) baseline score (intercept and time since randomization are included as random effects).|
1765481|NCT00083889|3240977|Superiority or Other||Hazard Ratio (HR)|0.5417|||<|1e-05|2-Sided|95.0|0.4519|0.6492||p—value is from 2—sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN—a.|Stratified Analysis: Hazard Ratio (SU011248 vs IFN—α)|
1765482|NCT00083889|3240977|Superiority or Other||Hazard Ratio (HR)|0.5454|||<|0.0001|2-Sided|95.0|0.4558|0.6526||p—value is from 2—sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio < 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio > 1 indicates a reduction in hazard rate in favor of IFN—a.|Unstratified Analysis: Hazard Ratio (SU011248 vs IFN—α)|
1765483|NCT00083889|3240978|Superiority or Other||Hazard Ratio (HR)|0.516|||<|1e-05|2-Sided|95.0|0.4191|0.6352||p—value is from 2—sided, stratified test. Stratification factors are: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN—a.|Stratified Analysis: Hazard Ratio (SU011248 vs IFN—a)|
1765484|NCT00083889|3240978|Superiority or Other||Hazard Ratio (HR)|0.5332|||<|0.0001|2-Sided|95.0|0.4345|0.6544||p—value is from 2—sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN—a|Unstratified Analysis: Hazard Ratio (SU011248 vs IFN—a)|
1765485|NCT00083889|3240979|Superiority or Other||Hazard Ratio (HR)|0.8179||||0.049|2-Sided|95.0|0.6692|0.9995||p—value is from 2—sided, stratified tests. Stratification factors were: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN—a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN—α).|
1765486|NCT00083889|3240979|Superiority or Other||Hazard Ratio (HR)|0.8209||||0.0128|2-Sided|95.0|0.673|1.0013||p-value is from 2—sided, unstratified tests.|Wilcoxon (Mann-Whitney)||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN—a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN—α).|
1765487|NCT00083889|3240979|Superiority or Other||Hazard Ratio (HR)|0.8209||||0.051|2-Sided|95.0|0.673|1.0013||p—value is from 2—sided, unstratified tests.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in hazard rate in favor of IFN—a|Unstratified analysis: Hazard Ratio (SU011248 vs IFN—α).|
1765488|NCT00083889|3240980|Superiority or Other||treatment difference|33.66|||<|0.001|2-Sided|95.0|27.62|39.69|||Chi-squared||95% confidence interval was calculated based on a normal distribution.||
1765489|NCT00083889|3240981|Superiority or Other||treatment difference|30.93|||<|0.001|2-Sided|95.0|25.31|36.56|||Chi-squared||95% confidence interval was calculated based on a normal distribution.||
1765490|NCT00083889|3240982|Superiority or Other||Hazard Ratio (HR)|0.5136|||<|1e-05|2-Sided|95.0|0.4196|0.6288||p-value is from 2-sided, stratified test. Stratification factors were: Lactic Dehydrogenase (LDH) > or <= 1.5 x upper limit of normal, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and absence or presence of prior nephrectomy.|Log Rank||Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favor of SU011248: a hazard ratio greater than 1 indicates a reduction in favor of IFN—a.|Stratified analysis: Hazard Ratio (SU011248 vs IFN—a).|
1765491|NCT00083889|3240982|Superiority or Other||Hazard Ratio (HR)|0.5268|||<|0.0001|2-Sided|95.0|0.4316|0.643||p-value from 2-sided, unstratified test.|Log Rank||Assuming proportional hazards, a hazard ratio les than 1 indicates a reduction in hazard rate in favor of SU011248; a hazard ratio greater than 1 indicates a reduction in favor of IFN-a.|Unstratified analysis: Hazard Ratio (SU011248 vs IFN—α). Progression-free survival (PFS) was assessed in each treatment arm using the Kaplan-Meier method.|
1765492|NCT00004146|3240985|Superiority or Other||Hazard Ratio (HR)|0.85||||0.1|2-Sided|95.0|0.65|1.12|||t-test, 1 sided|||the study design is to detect 30% reduction in hazard of deaths with 78% power at one side alpha level of 0.10. Overall survial time was calculated from time of histological diagnosis until time of death from any event.|
1765493|NCT00083759|3240986|Superiority or Other|||||||0.526|||||||Cochran-Mantel-Haenszel||||
1765494|NCT00083759|3240987|Superiority or Other|||||||0.171|||||||Cochran-Mantel-Haenszel||||
1765495|NCT00083759|3240988|Superiority or Other|||||||0.089|||||||Cochran-Mantel-Haenszel||||
1765496|NCT00083174|3241028|Superiority or Other (legacy)||Hazard Ratio (HR)|0.36||||0.07|2-Sided|95.0|0.11|1.12|||Log Rank||||
1765498|NCT00083174|3241030|Superiority or Other (legacy)||Hazard Ratio (HR)|0.35||||0.002|2-Sided|95.0|0.18|0.7|||Log Rank|||The null hypothesis was no difference between two groups. The sample size estimate was based on an assumption of annual invasive breast cancer rate of 0.60% in the placebo group and 0.21% in exemestane group, a relative reduction of 65% with exemestane. To detect this with a two-sided 5% level and 90% power, a total of 38 cases of invasive breast cancer were required, projected to occur when 4560 women were randomly assigned in a 3-year period and then followed for an additional 1.2 years.|
1765499|NCT00082628|3241039|Superiority or Other||||||<|0.001|||||||Nonparametric ANCOVA Model||||
1765500|NCT00082433|3241040|Superiority or Other||Hazard Ratio (HR)|0.85||||0.0231||95.0|0.75|0.98|||Regression, Cox|||This prespecified secondary analysis was a Cox model adjusted for age, Karnofsky performance status, number of organ sites, estrogen receptor status, hepatic impairment, time from diagnosis, liver/lung metastases.|
1765501|NCT00082433|3241040|Superiority or Other||Hazard Ratio (HR)|0.9||||0.1162||95.0|0.78|1.03||The test was stratified by (taxane resistance [yes/no], measurable disease versus non-measurable disease, prior chemotherapy for metastatic disease [yes/no], and anthracycline resistance [yes/no]).|Log Rank|The analysis was conducted at the 0.05 level and no adjustments were performed||This primary analysis was a comparison between the 2 treatment arms using a 2-sided, α=0.05 level log-rank test (to reject the null hypothesis of equality of survival). The analysis was conducted when 880 deaths (430 in combination:450 in capecitabine) were observed from the 1221 randomized participants.|
1765502|NCT00082433|3241041|Superiority or Other||||||<|0.0001|||||||Wei-Lachin|||There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.|
1765503|NCT00082433|3241045|Superiority or Other||Odds Ratio (OR)|1.89|||<|0.0001||95.0|1.44|2.5|||Cochran-Mantel-Haenszel||||
1765504|NCT00082433|3241046|Superiority or Other||Hazard Ratio (HR)|0.79||||0.0005||95.0|0.69|0.9|||Log Rank|||The analysis was conducted when 903 progressions or deaths (446 in combination:457 in capecitabine) were observed in 960 participants.|
1765505|NCT00082381|3241047|Superiority or Other|||||||0.3385|||||||ANCOVA||||
1765506|NCT00082381|3241048|Superiority or Other|||||||0.3002|||||||Fisher Exact||||
1765507|NCT00082381|3241050|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1765508|NCT00082381|3241051|Superiority or Other||||||<|0.0001|||||||ANCOVA||||
1765509|NCT00082381|3241052|Superiority or Other|||||||0.7839|||||||Fisher Exact||||
1765510|NCT00082381|3241053|Non-Inferiority or Equivalence|Pre-specified non-inferiority margin was 0.4% (i.e., noninferiority is demonstrated if the upper limit of a two-sided 95% confidence interval for the difference in change in HbA1c between exenatide and insulin glargine is less than 0.4%.)|Mean Difference (Final Values)|0.05||||0.4602||95.0|-0.09|0.2|||ANCOVA||||
1765511|NCT00082407|3241054|Superiority or Other|||||||0.3722|||||||ANCOVA||||
1765512|NCT00082407|3241055|Superiority or Other|||||||0.7888|||||||Fisher Exact||||
1765513|NCT00082407|3241057|Superiority or Other|||||||0.6456|||||||ANCOVA||||
1765514|NCT00082407|3241058|Superiority or Other|||||||0.0001|||||||ANCOVA||||
1765515|NCT00082407|3241059|Superiority or Other|||||||0.0779|||||||Fisher Exact||||
1765516|NCT00082407|3241060|Non-Inferiority or Equivalence|Pre-specified non-inferiority margin was 0.4% (i.e., noninferiority is demonstrated if the upper limit of a two-sided 95% confidence interval for the difference in change in HbA1c between exenatide and biphasic insulin aspart is less than 0.4%.)|Mean Difference (Final Values)|-0.1||||0.2534||95.0|-0.28|0.08|||ANCOVA||||
1765517|NCT00081770|3241086|Superiority or Other||Percentage of participants|45.0||||||95.0|42.0|48.1|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12||
1765518|NCT00081770|3241086|Superiority or Other||Percentage of participants|36.0||||||95.0|33.1|39.0|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12||
1765519|NCT00081770|3241086|Superiority or Other||Percentage of participants|39.9||||||95.0|36.9|42.9|||||Percentage of participants with undetectable HCV-RNA at Treatment Week 12||
1765520|NCT00081770|3241088|Superiority or Other||Odds Ratio (OR)|1.08||||0.195||95.0|0.9|1.3||Holm’s method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.|Regression, Logistic|The p-value is based on the logistic regression model that includes treatment and baseline stratification factors (viral load and race).|The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs >600,000 IU/mL) and race (Black vs non-Black).||
1765521|NCT00081770|3241088|Superiority or Other||Odds Ratio (OR)|0.95||||0.567||95.0|0.79|1.14||Holm’s method for multiplicity adjustment was to be used to control the overall Type I error rate at α = 0.05. However, since there was no significant difference in the overall SVR rates between the three groups, no Type-1 error adjustment was made.|Regression, Logistic|The p-value is based on the logistic regression model that includes treatment and baseline stratification factors (viral load and race).|The odds ratio is based on the logistic regression model that includes treatment and baseline stratification factors: viral load (≤600,000 IU/mL vs >600,000 IU/mL) and race (Black vs non-Black).||
1765522|NCT00081497|3241106|Superiority or Other||Mean Difference|2.33||||0.1268||95.0|-0.685|5.345|||Mixed Effects Model|||Statistical Analysis 2 represents the post-hoc outcome results for difference in slope mean of eGFR subgroup ≤ 60.|
1765523|NCT00081497|3241106|Superiority or Other||Mean Difference|-6.787||||0.0027||95.0|-11.123|-2.45|||Mixed Effects Model|||Statistical Analysis 1 represents the post-hoc outcome results for difference in slope mean of eGFR subgroup >60.|
1765524|NCT00081497|3241107|Superiority or Other||Change in Slope Mean|-0.029||||0.013||95.0|-0.051|-0.007|||Mixed Models Analysis|Mixed effects model with a population level (fixed effect) intercept and slope and a subject level (random effect) intercept and slope.||The statistical analysis represents the primary outcome measure results.|
1765525|NCT00081458|3241108|Superiority or Other|||||||0.005|||||||ANCOVA|||An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.|
1765527|NCT00080912|3241161|Non-Inferiority or Equivalence (legacy)|The original sample size was determined based on the non-inferiority. The original sample size is based on assumption of response rate on the multiple fraction arm is 70%, 260 patients were required in each treatment arm to have 80% power to exclude, with a one sided alpha of 0.05, a response rate of 60% or less in the single fraction radiation group (non-inferiority margin =10%). Given an inevaluability rate of 30%, 850 patients (425 for each treatment arm) were randomized to the study.|Risk Difference (RD)|4.0||||0.03|1-Sided|95.0||9.2||p-value is for one-sided non-inferiority test|Cochran-Mantel-Haenszel||The upper limit of one-sided 95% CI for the response rate difference was 9.2%, which was below the pre-specified 10% non-inferiority boundary||
1765528|NCT00002525|3241172|Superiority or Other|||||||0.847||||||two-sided log rank test|Log Rank||||
1765529|NCT00002525|3241173|Superiority or Other|||||||0.178||||||one-sided log-rank test p value|Log Rank||||
1765530|NCT00080301|3241176|Superiority or Other|||||||0.0002|||||||Wei-Lachin|||There was a statistically significant difference between groups in change from baseline FBSI score favoring capecitabine. A mean change from baseline of 2.5 was considered a clinically meaningful difference (minimally important difference or MID). On-treatment mean changes in the FBSI did not reach the MID in either group.|
1765531|NCT00080301|3241178|Superiority or Other||Hazard Ratio (HR)|0.9||||0.1936||95.17|0.77|1.05||Test was stratified by presence of visceral metastases in liver or lung (y/n), minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse > 6 months in adjuvant setting (y/n), and prior chemotherapy for metastatic disease (y/n).|Log Rank|Test was conducted at the α=0.05 level and no adjustments were performed.|Confidence Interval adjusted for interim analysis.|Study required 631 deaths to achieve 80% power to detect a Hazard ratio of 0.8 using a 2-sided α = 0.05 log rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.05 log-rank test to reject the null hypothesis of equality of survival. The analysis was conducted when 639 deaths (318 in combination:321 in capecitabine) were observed from the 752 randomized patients.|
1765532|NCT00080301|3241181|Superiority or Other||Odds Ratio (OR)|3.15|||<|0.0001||95.0|2.2|4.5|||Cochran-Mantel-Haenszel|||The study had 95 percent power to detect a significant difference in ORR if the true response rate was 32 percent in the combination arm and 20 percent in the capecitabine arm.|
1765533|NCT00080301|3241182|Superiority or Other||Hazard Ratio (HR)|0.75||||0.0003||95.17|0.64|0.88||Test was stratified by 1) presence of visceral metastases in liver or lung, 2) minimum of either doxorubicin 420 mg/m2 or epirubicin 360 mg/m2, and relapse > 6 months in adjuvant setting, and 3) prior chemotherapy for metastatic disease. (yes/no)|Log Rank|95.17% confidence interval is adjusted for the interim analysis.||Study required 615 events to achieve 90% power to detect a hazard ratio of 0.77 using a 2-sided α = 0.05 log-rank test. The analysis was a comparison between the 2 treatment arms using a 2-sided α=0.0483 log-rank test (adjusted for an interim analysis using the O’Brien Fleming spending function) to reject the null hypothesis of equality of progression free survival. The analysis was conducted when 639 events (310 in combination:329 in capecitabine) were observed from the 752 randomized patients.|
1765534|NCT00080288|3241183|Superiority or Other|||||||0.001|||||||Cochran-Mantel-Haenszel|The p value for each treatment group is for the comparison of that treatment group to the placebo treatment group. Adjusted for country.||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.|
1765535|NCT00080288|3241184|Superiority or Other||Mean Difference (Final Values)|2.7|||<|0.0001||95.0|1.67|3.69|||ANCOVA|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.|
1765536|NCT00002540|3241192|Superiority or Other (legacy)||Hazard Ratio (HR)|1.09|||||2-Sided|95.0|0.87|1.36|||||||
1765537|NCT00002540|3241202|Superiority or Other (legacy)||Hazard Ratio (HR)|1.12|||||2-Sided|95.0|1.07|1.17|||||||
1765538|NCT00002540|3241204|Superiority or Other (legacy)||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.93|1.0|||||||
1765539|NCT00002540|3241206|Superiority or Other (legacy)||Hazard Ratio (HR)|1.09|||||2-Sided|95.0|0.87|1.36|||||||
1765540|NCT00080119|3241214|Superiority or Other||Hazard Ratio (HR)|0.85||||0.43|2-Sided|95.0|0.55|1.3||Threshold p-value for significance = 0.0493|Log Rank||Hazard ratio for INH relative to Placebo||
1765541|NCT00080119|3241215|Superiority or Other||Hazard Ratio (HR)|0.98||||0.93|2-Sided|95.0|0.67|1.44||Threshold p-value for significance = 0.0492|Log Rank||Hazard ratio for INH relative to Placebo||
1765542|NCT00009737|3241225|Non-Inferiority or Equivalence|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25|Hazard Ratio (HR)|0.84||||0.071|2-Sided|95.0|0.69|1.01||For difference between arms, < 0.001 for non-inferiority|Wald Chi-Square Test||||
1765543|NCT00009737|3241226|Non-Inferiority or Equivalence|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25|Hazard Ratio (HR)|0.86||||0.041|2-Sided|95.0|0.74|0.99||For difference between arms, < 0.001 for non-inferiority|Wald Chi-Square Test||||
1765544|NCT00009737|3241227|Non-Inferiority or Equivalence|Non-inferiority was tested by comparing the upper limit of the 95% confidence interval for the hazard ratio to the non-inferiority margin of 1.25 in a first step, and then of 1.20 in a second step.|Hazard Ratio (HR)|0.87||||0.053|2-Sided|95.0|0.75|1.0||For difference between arms, < 0.001 for non-inferiority|Wald Chi-Square Test||||
1765545|NCT00079677|3241231|Superiority or Other|||||||0.0069||||||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|Cochran-Mantel-Haenszel|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05.|
1765546|NCT00079677|3241232|Superiority or Other||Mean Difference (Final Values)|3.5||||0.0003||95.0|1.67|5.46||The p-value for each treatment group is for the comparison of that treatment group to the placebo treatment group.|ANOVA|||Assumption: both primary treatment comparisons would be with a 2 sided test at an alpha level of 0.05|
1765547|NCT00079274|3241257|Superiority||||||<|0.001|||||||Chi-squared|Two-sided chi-squared test|||
1765548|NCT00079274|3241258|Superiority||||||<|0.001|||||||Chi-squared|two-sided chi-squared test|||
1765549|NCT00079274|3241259|Superiority||Hazard Ratio (HR)|1.27||||0.25|2-Sided|95.0|0.85|1.92|||Regression, Cox|HR and p-value reported from a multivariate Cox PH regression model, adjusted for number of nodes, histologic grade, and T stage.|||
1765554|NCT00079001|3241280|Non-Inferiority or Equivalence (legacy)|Superiority and futility analysis were conducted for time to first SRE. Lan-Demets analog of the Emerson-Fleming sequential boundary was used to maintain overall significance level of α = .05 while conducting interim analyses on time to first SRE.|Hazard Ratio (HR)|0.97||||0.385|2-Sided|95.0|0.0|1.174||Because of early termination, conditional power was performed under the alternative hypothesis. This is the probability that zoledronic acid is superior to placebo, given time to first SRE data at interim analysis under alternative hypothesis.|Log Rank||Patients randomly assigned to zoledronic acid were compared with patients assigned to placebo|The null hypothesis was that the hazard ratio is greater than or equal to 1.0 versus the alternative hypothesis that the hazard ratio is less than 0.77. With a target of 470 SREs, log-rank statistic had 88% power to detect a 23% decrease in hazard of SRE (equivalent to an increase in median time to SRE from 30 months to 39 months), assuming a one-sided type I error rate of .05.|
1765555|NCT00078949|3241282|Superiority or Other (legacy)||Hazard Ratio (HR)|0.77||||0.17|2-Sided|95.0|0.52|1.12|||Log Rank|||It was estimated that 240 patients will be eligible for the maintenance question, and randomized with a 1:1 ratio to either rituximab or observation. It is expected that the 2-year event-free survival will be 50% on the observation arm. In order to detect a 15% difference in the 2-year event-free survival with an 80% power using a two-sided 5% level test, 142 events are required to detect an HR of 0.622.|
1765556|NCT00078949|3241283|Superiority or Other (legacy)||Risk Difference (RD)|-2.1||||0.55||95.0|-10.0|5.8|||Cochran-Mantel-Haenszel||||
1765557|NCT00078949|3241284|Non-Inferiority or Equivalence (legacy)|The literature has suggested that the ORR is approximately 50% for this patient population treated with DHAP. The treatment difference is defined as the response rate for the DHAP arm minus that of GDP arm. We would consider GDP to be non-inferior to DHAP if we are 95% sure that the true difference is less than 10%. In order to rule out that the 10% difference with 80% power, we need to accrue a total of 630 eligible patients. The actual sample size for this final analysis is 619 patients.|Risk Difference (RD)|-1.2||||0.005|2-Sided|95.0|-9.0|6.7||p-value for non-inferiority|Cochran-Mantel-Haenszel||||
1765558|NCT00078897|3241285|Other|Negative binomial regression|Risk Ratio (RR)|1.03||||0.68|2-Sided|95.0|0.91|1.16|||Negative binomial regression||||
1765559|NCT00078819|3241289|Superiority|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician’s global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group|||
1765560|NCT00078819|3241290|Superiority|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician’s global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Van Elteren test|Two-sided van Elteren's test stratified by age group|||
1765561|NCT00078819|3241291|Superiority|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician’s global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group|||
1765562|NCT00078819|3241292|Superiority|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician’s global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group|||
1765563|NCT00078819|3241293|Superiority|The significance levels for primary and secondary efficacy end points were controlled at 0.05 with the use of a sequential testing scheme in this order: PASI 75, PASI 50, a physician’s global assessment of clear or almost clear, percentage improvement from baseline in CDLQI, and PASI 90.|||||<|0.0001|||||||Cochran-Mantel-Haenszel|Two-sided Cochran-Mantel-Haenszel test stratified by age group|||
1765564|NCT00078754|3241315|Superiority or Other|||||||0.622|||||||ANCOVA||||
1765565|NCT00078715|3241318|Superiority or Other (legacy)||Mean Difference (Net)|-1.004|Standard Error of the Mean|1.141||0.527|2-Sided|95.0|-4.26|2.251||The significance level reflects the direct comparison of drugs after factoring out baseline depression levels.|Mixed Models Analysis|A linear mixed model was used with factors for drug, time of evaluation, the drug by time interaction, and a baseline depression covariate.||The hypothesis was that yohimbine would provide lower levels of depression than placebo. Initial estimates of sample size assumed a minimum of 25 patients were required to detect differences in depression.|
1765566|NCT00005947|3241319|Superiority or Other||Hazard Ratio (HR)|0.586||||0.01|2-Sided|95.0|0.388|0.884|||Log Rank||Cox proportional hazards model with treatment as the independent variable [sipuleucel-T/placebo]|ITT Population - all randomized participants.|
1765567|NCT00005947|3241319|Superiority or Other||Hazard Ratio (HR)|1.71||||0.01||95.0|1.13|2.58|||Log Rank||Cox proportional hazards model with treatment as the independent variable [placebo/sipuleucel-T].|ITT Population - all randomized participants|
1765568|NCT00005947|3241320|Superiority or Other||Hazard Ratio (HR)|0.69||||0.052|2-Sided|95.0|0.47|1.01|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable [sipuleucel-T/placebo]||
1765569|NCT00005947|3241320|Superiority or Other||Hazard Ratio (HR)|1.45||||0.052||95.0|0.99|2.11|||Log Rank||Obtained from a Cox proportional hazards model with treatment group as the independent variable [placebo/sipuleucel-T].||
1765570|NCT00078559|3241326|Superiority or Other||Exact Binomial|0.0|||||2-Sided|95.0|0.0|0.8|||||||
1765571|NCT00078559|3241326|Superiority or Other||Exact Binomial|0.0|||||2-Sided|95.0|0.0|0.4|||||||
1765572|NCT00078559|3241327|Superiority or Other||Exact Binomial|0.0|||||2-Sided|95.0|0.0|0.8|||||||
1765573|NCT00078559|3241327|Superiority or Other||Exact Binomial|0.0|||||2-Sided|95.0|0.0|0.4|||||||
1765574|NCT00078559|3241328|Superiority or Other||Exact Binomial|0.0|||||2-Sided|95.0|0.0|0.3|||||||
1765575|NCT00078559|3241329|Superiority or Other||Exact Binomial|0.0|||||2-Sided|95.0|0.0|0.3|||||||
1765576|NCT00078559|3241332|Superiority or Other||Proportion with acute rejection|0.0|||||2-Sided|95.0|0.0|0.7|||||||
1765584|NCT00002597|3241340|Superiority||Hazard Ratio (HR)|1.45||||0.035|2-Sided|95.0|1.03|2.06|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.|
1765585|NCT00002597|3241341|Superiority||Hazard Ratio (HR)|1.5||||0.0013|2-Sided|95.0|1.17|1.93|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray's test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine-Gray model was used to calculate hazard ratios.|
1765586|NCT00002597|3241342|Superiority||Hazard Ratio (HR)|1.86||||0.001|2-Sided|95.0|1.27|2.74|||Gray's test||Reference level = Hormone Therapy + Radiation Therapy|Gray’s test was used to compare cumulative incidence between treatment arms (1-sided significance level of 0.025) and the Fine–Gray model was used to calculate hazard ratios.|
1765587|NCT00002597|3241343|Superiority||Hazard Ratio (HR)|1.17||||0.0309|2-Sided|95.0|1.01|1.35|||Log Rank||Reference level = Hormone Therapy + Radiation Therapy|Null hypothesis: 8-year OS rate of 60% radiation therapy (RT) alone vs. 67% with hormone therapy. The study was designed with 90% power to detect a 7-percentage- point absolute difference in the 8-year survival rate, with the use of a one-sided log-rank test at the 0.025 significance level, requiring 1980 patients and 716 deaths for definitive analysis.|
1765588|NCT00078377|3241344|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel||||
1765589|NCT00078377|3241345|Superiority or Other||Mean Difference (Final Values)|3.8||||0.0024||95.0|1.02|4.61|||ANCOVA|The corresponding baseline value as a covariate.||Statistical data is for the Armodafinil Combined treatment (250 mg/day and 150 mg/day groups) compared to the placebo treatment group|
1765590|NCT00078338|3241346|Superiority or Other||Hazard Ratio (HR)|0.943||||0.643|2-Sided|95.0|0.74|1.21|||Cox proportional hazards model||||
1765591|NCT00078403|3241368|Superiority or Other|||||||0.58||||||P-value is pre-specified 1-sided test that PEG slows liver fibrosis progression. Accrual and follow-up on Arms A and B were halted at interim review for lack of fibrosis progression in Arm B (control arm). P-value is unadjusted for interim analysis.|Exact Wilcoxon rank sum test|||Accrual and follow-up on Arms A and B were halted for futility at the first independent interim review of the primary endpoint conducted on May 2, 2007.|
1765592|NCT00078325|3241369|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Adjusted for country.|||
1765593|NCT00078325|3241369|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Adjusted for country.|||
1765594|NCT00078325|3241370|Superiority or Other|||||||0.0008|||||||ANOVA|Treatment and country as factors.|||
1765595|NCT00078325|3241370|Superiority or Other|||||||0.0001|||||||ANOVA|Treatment and country as factors.|||
1765596|NCT00078286|3241372|Superiority or Other||Odds Ratio (OR)|0.08||||0.78||95.0|||||Cochran-Mantel-Haenszel|||Tests for differences of proportions were used to examine the composite cardiovascular status outcome at the end of acute treatment. Chi-square tests were used to test for overall treatment differences, with a Mantel Haenszel test performed to examine treatment differences when controlling for clinical site. The primary analyses were conducted on the tri-level cardiovascular status outcome.|
1765597|NCT00078286|3241373|Non-Inferiority or Equivalence|*Power analysis already provided.|Difference in mean change score|-0.3||||0.89||95.0|||||Mixed Models Analysis|Significance was tested at p=.05.||A hierarchical mixed model was used, analyzing the fixed effects of treatment, the natural log of time, natural log of time squared, the interactions of time and time squared with treatment and site, as well as the random effects of patient, patient-by-time, and square of patient-by-time.|
1765598|NCT00077974|3241385|Superiority or Other||Percent|33.0||||||95.0|24.2|42.8|||||Using exact method based on binomial distribution. Percent equals n divided by N times 100.||
1765599|NCT00077766|3241399|Non-Inferiority or Equivalence|Non-inferiority with 90% power assuming that the true difference between the RO0503821 group and darbepoetin was not larger than 0.3 g/dL.|Mean Difference (Final Values)|0.18|Standard Error of the Mean|0.1162|<|0.0001|2-Sided|95.0|-0.049|0.408||The p-value for the non-inferiority test was derived using ANCOVA.|ANCOVA, CI for difference between groups|Degrees of Freedom : 246|Difference between groups based on the adjusted means derived from the ANCOVA model.|RO0503821 group was compared to darbepoetin alfa group, using analysis of covariance (ANCOVA) with the independent variable as treatment group and Hb at baseline and geographical region as covariates. The test for non-inferiority was based on the lower limit of 2-sided 95% confidence interval (CI) for difference in adjusted mean between 2 groups. If this lower limit was > or = to -0.75 g/dL, the RO0503821 group was regarded as clinically non-inferior to darbepoetin alfa group, with 90% power.|
1765600|NCT00077675|3241402|Non-Inferiority or Equivalence|Sample size was selected on the basis of clinical judgment and was deemed adequate to provide clinically meaningful descriptive results consistent with study objectives. This sample size was estimated to provide 91% power to test telavancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 20%||||||0.5318|||||||2-sided 95% confidence interval calculat|||95% Confidence Interval: -0.0527 to 0.1102 No estimated value Parameter that was estimated: Risk Difference|
1765601|NCT00077636|3241417|Non-Inferiority or Equivalence|These results indicated that sustained virological response achieved with 16 weeks of treatment was not equivalent to that achieved with 24 week of treatment.|Odds Ratio (OR)|0.65||||0.0003|2-Sided|95.0|0.52|0.82|||Cochran-Mantel-Haenszel|stratified by country and HCV genotype.|||
1765602|NCT00077636|3241418|Non-Inferiority or Equivalence|In the analysis based on the standard population, end of treatment virological response was equivalent in the two treatment arms (94% in the 16-week arm and 92% in the 24-week arm).|Odds Ratio (OR)|1.32||||0.1941|2-Sided|95.0|0.86|2.03|||Cochran-Mantel-Haenszel|stratified by country.|||
1765603|NCT00077636|3241419|Non-Inferiority or Equivalence|These results indicated that sustained virological response achieved with 16 weeks of treatment was not equivalent to that achieved with 24 week of treatment.|Odds Ratio (OR)|0.59|||<|0.0001|2-Sided|95.0|0.46|0.76|||Cochran-Mantel-Haenszel|stratified by country and HCV genotype.|||
1765633|NCT00076999|3241476|Superiority or Other|||||||0.6|||||||Fisher Exact|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765634|NCT00076999|3241477|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765635|NCT00076999|3241477|Superiority or Other|||||||0.06|||||||Fisher Exact|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765604|NCT00077623|3241428|Non-Inferiority or Equivalence|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority were based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to –0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity .|Mean Difference between groups|-0.022|||<|0.0001|2-Sided|97.5|-0.262|0.217||The p-value for the non-inferiority test can be derived via the t-test.|ANCOVA, CI for difference between groups|||The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)|
1765605|NCT00077623|3241428|Non-Inferiority or Equivalence|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority were based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to –0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.141|||<|0.0001|2-Sided|97.5|-0.098|0.38||The p-value for the non-inferiority test can be derived via the t-test.|ANCOVA, CI for difference between groups|||The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL (Per Protocol Population)|
1765606|NCT00077610|3241436|Non-Inferiority or Equivalence|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to -0.3 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.051|Standard Error of the Mean|0.0997|<|0.0001|2-Sided|97.5|-0.173|0.275|||ANCOVA, CI for difference between groups||Difference between groups based on the adjusted means derived from the ANCOVA model|The non-inferiority test for treatment differences in Hb change from baseline, based on ANCOVA analysis with a non-inferiority limit of -0.75 g/dL.|
1765607|NCT00077610|3241436|Non-Inferiority or Equivalence|The two RO0503821 dosing schedules were compared separately to epoetin reference using ANCOVA, with Hb at BL and region as the covariates. The test for non-inferiority was based on the lower limit of the two-sided 97.5% confidence interval for the difference between the two groups. When the lower limit was greater than or equal to –0.75 g/dL, the RO0503821 groups were regarded as non-inferior to the epoetin reference group. The confidence level of 97.5% was chosen to adjust for multiplicity.|Mean Difference between groups|0.004|Standard Error of the Mean|0.0973|<|0.0001|2-Sided|97.5|-0.215|0.223|||ANCOVA, CI for difference between groups||Difference between groups based on the adjusted means derived from the ANCOVA model|The non-inferiority test for treatment differences in Hb change from baseline, based on analysis of co-variance (ANCOVA) analysis with a non-inferiority limit of -0.75 g/dL.|
1765608|NCT00077376|3241443|Superiority or Other||Objective response rate|44.0|||||2-Sided|95.0|31.0|58.0|||||||
1765609|NCT00077376|3241444|Superiority or Other||Objective response rate|41.0|||||2-Sided|95.0|26.0|58.0|||||||
1765610|NCT00076999|3241462|Superiority or Other|||||||0.23|||||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765611|NCT00076999|3241462|Superiority or Other|||||||0.23|||||||ANOVA|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765612|NCT00076999|3241463|Superiority or Other|||||||0.36|||||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765613|NCT00076999|3241463|Superiority or Other|||||||0.08|||||||ANOVA|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765614|NCT00076999|3241464|Superiority or Other|||||||0.2|||||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765615|NCT00076999|3241464|Superiority or Other|||||||0.38|||||||ANOVA|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765616|NCT00076999|3241466|Superiority or Other|||||||0.79|||||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765617|NCT00076999|3241466|Superiority or Other|||||||0.73|||||||ANOVA|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765618|NCT00076999|3241467|Superiority or Other|||||||0.7|||||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765619|NCT00076999|3241467|Superiority or Other|||||||0.25|||||||ANOVA|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765620|NCT00076999|3241468|Superiority or Other|||||||0.26|||||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765621|NCT00076999|3241468|Superiority or Other|||||||0.64|||||||ANOVA|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765622|NCT00076999|3241470|Superiority or Other|||||||0.69|||||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765623|NCT00076999|3241470|Superiority or Other|||||||0|||||||ANOVA|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765624|NCT00076999|3241471|Superiority or Other|||||||0.81|||||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765625|NCT00076999|3241471|Superiority or Other|||||||0|||||||ANOVA|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765626|NCT00076999|3241472|Superiority or Other|||||||0.47|||||||ANOVA|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765627|NCT00076999|3241472|Superiority or Other|||||||0.02|||||||ANOVA|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765628|NCT00076999|3241474|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765629|NCT00076999|3241474|Superiority or Other|||||||0.18|||||||Fisher Exact|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765630|NCT00076999|3241475|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765631|NCT00076999|3241475|Superiority or Other|||||||0.2|||||||Fisher Exact|||Comparison of TPV OS 2-<6 yrs versus TPV OS 6-<12 yrs|
1765632|NCT00076999|3241476|Superiority or Other|||||||1|||||||Fisher Exact|||Comparison of TPV OS 12-18 yrs versus TPV SEDDS 12-18 yrs|
1765911|NCT00070707|3241999|Superiority or Other|Change at Week 4 (AM)||||||0.348|||||||ANOVA||||
1765647|NCT00003222|3241484|Superiority or Other|||||||0.13|||||||Chi-squared|||This is a test for differences between the response rates of the two arms. The null hypothesis is that the arms have equal response rates and the alternative hypothesis is that they are different.|
1765648|NCT00076804|3241486|Superiority or Other|||||||0.61||||||Logistic regression analysis & Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Wilcoxon (Mann-Whitney)|||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier|
1765649|NCT00076804|3241487|Superiority or Other|||||||0.14||||||Logistic regression analysis & Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Wilcoxon (Mann-Whitney)|||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier|
1765650|NCT00076804|3241488|Superiority or Other|||||||0.89||||||Logistic regression analysis & Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Chi-squared|one degree of freedom||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher's exact and Kaplan-Meier|
1765651|NCT00076804|3241489|Superiority or Other|||||||0.42||||||Logistic regression analysis & Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence|Chi-squared|one degree of freedom||Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher’s exact and Kaplan–Meier|
1765652|NCT00076258|3241520|Superiority or Other||Remission Rate|28.3|||<|0.05|2-Sided||||||Generalized Linear Mixed Model|||For the covariate adjusted GLMM the remission rates were 15.5 for the LD and 28.3 for the PHD with a p < 0.06 and the NNT of 7.8 for the PHD versus the LD.|
1765653|NCT00076258|3241520|Superiority or Other||Remission rate|29.5|||<|0.05|2-Sided||||||Generalized Linear Mixed Model|Both unadjusted and adjusted rates (for significant covariates) were reported|||
1765654|NCT00076219|3241523|Superiority or Other||Odds Ratio (OR)|1.09|Standard Error of the Mean|0.12||0.47|2-Sided|95.0|0.86|1.4|||Regression, Logistic||||
1765655|NCT00076102|3241528|Other|||||||0.6774|||||||ANOVA|||F=0.18 under the null hypothesis|
1765656|NCT00076102|3241528|Other|||||||0.8466|||||||ANOVA|||F=0.04 under the null hypothesis|
1765657|NCT00076102|3241528|Other|||||||0.2767|||||||ANOVA|||F=1.27 under the null hypothesis|
1765658|NCT00076102|3241528|Other|||||||0.5877|||||||ANOVA|||F=0.31 under the null hypothesis|
1765659|NCT00076102|3241528|Other|||||||0.3625|||||||ANOVA|||F= 0.87 under the null hypothesis|
1765660|NCT00076102|3241528|Other|||||||0.6263|||||||ANOVA|||F=0.25 under the null hypothesis|
1765661|NCT00076102|3241529|Other|||||||0.0032||||||The reported p-value is representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Medical/Physical Status.|ANOVA|||F=11.23 under the null hypothesis|
1765662|NCT00076102|3241529|Other|||||||0.0186||||||The reported p-value is representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Emotional Functioning.|ANOVA|||F = 6.56 under the null hypothesis|
1765663|NCT00076102|3241529|Other|||||||0.0301||||||The reported F statistic and p-value are representative of the difference in the Parent proxy Form and the Child Self-Report Form response for Adaptive Behavior.|ANOVA|||F=5.45 under the null hypothesis|
1765664|NCT00076024|3241540|Superiority or Other||Difference in response rates|17.4||||0.038|2-Sided|95.0|3.0|31.9|||Fisher Exact||||
1765665|NCT00076024|3241541|Superiority or Other||Hazard Ratio (HR)|1.237||||0.156|2-Sided|95.0|0.819|1.867|||Log Rank|One-sided log-rank test at alpha = 0.1 significance level was used.||P-value was calculated using one-sided Log rank test, stratified for estrogen receptor (ER) status (ER-positive or ER-negative/unknown), prior adjuvant chemotherapy (yes or no), and Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to [=<1] or 2). The stratified Cox proportional hazards model was fitted, using the same stratification variables as above.|
1765666|NCT00075946|3241548|Superiority or Other|||||||0.27|||||||t-test, 2 sided||||
1765667|NCT00075946|3241549|Superiority or Other|||||||0.0002|||||||Log Rank||||
1765668|NCT00075946|3241549|Superiority or Other||Hazard Ratio (HR)|3.21||||0.002|2-Sided|95.0|1.45|7.13|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.||
1765669|NCT00075946|3241550|Superiority or Other||Hazard Ratio (HR)|2.75||||0.012|2-Sided|95.0|1.22|6.19|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in non-follicular patients.||
1765757|NCT00071981|3241872|Superiority or Other|||||||0.741|||||||Fisher Exact|||Compare objective response rate among four arms. The null hypothesis is that objective response rate is same in all four arms. Alternative hypothesis is that objective response rate is different in at least one arm compared to other arms.|
1765670|NCT00075946|3241550|Superiority or Other||Hazard Ratio (HR)|1.3||||0.33|2-Sided|95.0|0.9|1.88|||Log Rank||Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.|The primary analysis is to compare the time to rituximab failure (TTRF) between the retreatment arm and the scheduled arm in follicular patients.|
1765671|NCT00075764|3241594|Other||Hazard Ratio (HR)|0.81||||0.049|2-Sided|95.0|0.65|1.0|||Log Rank|A log-rank test, stratified according to prior or no prior tamoxifen therapy.|||
1765672|NCT00075764|3241596|Other||Hazard Ratio (HR)|0.8||||0.007|2-Sided|95.0|0.68|0.94|||Log Rank|Two-sided stratified log-rank test|||
1765673|NCT00075478|3241616|Superiority or Other||Hazard Ratio (HR)|0.56||||0.05|2-Sided|95.0|0.3|1.0|||Regression, Cox||||
1765674|NCT00075478|3241618|Superiority or Other||Hazard Ratio (HR)|1.52||||0.14|2-Sided|95.0|0.9|2.7|||Regression, Cox||||
1765675|NCT00075478|3241619|Superiority or Other||Hazard Ratio (HR)|1.6||||0.16|2-Sided|95.0|0.8|3.1|||Regression, Cox||||
1765676|NCT00075478|3241620|Superiority or Other||Hazard Ratio (HR)|0.53||||0.09|2-Sided|95.0|0.3|1.1|||Regression, Cox||||
1765677|NCT00075478|3241621|Superiority or Other||Hazard Ratio (HR)|0.55||||0.06|2-Sided|95.0|0.3|1.0|||Regression, Cox||||
1765678|NCT00075478|3241622|Superiority or Other||Hazard Ratio (HR)|0.67||||0.59|2-Sided|95.0|0.1|3.0|||Regression, Cox||||
1765679|NCT00075478|3241623|Superiority or Other||Hazard Ratio (HR)|0.57||||0.09|2-Sided|95.0|0.3|1.1|||Regression, Cox|||Reference arm is Arm 2.|
1765680|NCT00075270|3241655|Superiority or Other||Hazard Ratio, log|0.82||||0.094|2-Sided|95.0|0.65|1.04||P-value from stratified log-rank test, stratifying for stage of disease and site of disease at screening|Log Rank||The estimate of the treatment hazard ratio was based on the log-rank test.||
1765681|NCT00075270|3241656|Superiority or Other||Hazard Ratio, log|0.87||||0.142|2-Sided|95.0|0.72|1.05||P-value from stratified log-rank test, stratifying for stage of disease and site of disease at screening|Log Rank||The estimate of the treatment hazard ratio is based on the log-rank test.||
1765682|NCT00075218|3241659|Superiority or Other||Treatment Difference (percent)|17.3||||0.0046||95.0|6.7|28.0|||Pearson chi-square||95% CI of Difference based on normal distribution. Percent = (number of subjects with response per total subjects per treatment in defined analysis population)*100.||
1765683|NCT00075218|3241660|Superiority or Other||Hazard Ratio (HR)|0.972||||0.9322||95.0|0.508|1.86|||Log Rank|2-sided, unstratified log-rank test|||
1765684|NCT00075218|3241661|Superiority or Other||Hazard Ratio (HR)|0.327|||<|0.001||95.0|0.232|0.46|||Log Rank|log—rank test of treatment stratified by prior imatinib mesylate response and McGill Pain Questionnaire's Present Pain Intensity score||Stratified log-rank test|
1765685|NCT00075218|3241661|Superiority or Other||Hazard Ratio (HR)|0.339|||<|0.001||95.0|0.244|0.472||two-sided unstratified log-rank test|Log Rank||||
1765686|NCT00075218|3241664|Superiority or Other||Treatment Difference (%)|6.58||||0.004||95.0|3.47|9.7||No p-value adjustment for multiple comparisons.|Pearson chi-square test||||
1765687|NCT00075218|3241664|Superiority or Other||rate (percentage)|6.6||||||95.0|3.8|10.5|||||Used exact method based on binomial distribution.||
1765688|NCT00075218|3241666|Superiority or Other||Hazard Ratio (HR)|0.505||||0.306||95.0|0.262|1.134||No p-value adjustment for multiple comparisons.|Rank Preserving Structural Failure Time||95% CI for Hazard Ratio is from 2.5% and 97.5% Empirical Percentiles of 100,000 Bootstraps.||
1765689|NCT00075218|3241667|Superiority or Other||Hazard Ratio (HR)|0.876||||0.306||95.0|0.679|1.129||No p-value adjustment for multiple comparisons.|Log Rank||||
1765690|NCT00075218|3241669|Superiority or Other||Hazard Ratio (HR)|0.347|||<|0.001||95.0|0.253|0.475||No p-value adjustment for multiple comparisons.|Log Rank||||
1765691|NCT00075218|3241670|Superiority or Other||Hazard Ratio (HR)|0.329|||<|0.001||95.0|0.233|0.466||The nominal levels of significance for the interim and final analyses were determined at the time of the analyses using the Lan-DeMets procedure with an O’Brien-Fleming stopping rule.|Log Rank|two-sided unstratified log-rank test||The study was designed to test the null hypothesis that the median TTP from placebo treatment is 4 months versus the alternative hypothesis that the median TTP from sunitinib treatment is at least 6 months with an overall 2-sided significance level of 0.05 and power of 90%.|
1765692|NCT00074984|3241678|Superiority or Other||Hazard Ratio (HR)|0.732||||0.5261|2-Sided|95.0|0.278|1.927|||Log Rank|2-sided log-rank test||Analysis of Time to First Renal Event for ITT population.|
1765693|NCT00074984|3241679|Superiority or Other||Cox Proportional Hazard|0.465||||0.0577|2-Sided|95.0|0.211|1.025|||Wald Test|||Time to First Primary Endpoint Adjusting for Baseline Proteinuria using Cox Proportional Hazards Model|
1765694|NCT00074984|3241679|Superiority or Other||Hazard Ratio (HR)|0.574||||0.1449|2-Sided|95.0|0.269|1.222|||Log Rank|Comparison is based on a 2-sided log-rank test.|||
1765695|NCT00074802|3241686|Superiority||Median Difference (Net)|0.41||||0.949|2-Sided|95.0|-11.95|12.76|||Mixed Models Analysis||||
1765696|NCT00074802|3241687|Superiority||Mean Difference (Net)|0.2||||0.871|2-Sided|95.0|-2.16|2.55|||Mixed Models Analysis||||
1765697|NCT00074802|3241688|Superiority||Mean Difference (Net)|-5.53||||0.0006|2-Sided|95.0|-8.7|-2.35|||Mixed Models Analysis||Paroxetine+CBT > Paroxetine alone in BFNE change.||
1765698|NCT00074802|3241689|Superiority||Mean Difference (Net)|-5.61||||0.0775|2-Sided|95.0|-11.84|0.62|||Mixed Models Analysis||||
1765699|NCT00074802|3241690|Superiority||Mean Difference (Net)|-3.21||||0.0005|2-Sided|95.0|-5.02|-1.39|||Mixed Models Analysis||||
1765700|NCT00074802|3241691|Superiority|||||||0.034||||||Fisher's Exact Test used for analyses.|Fisher Exact|||Fisher's Exact Test used for analyses of remitter status.|
1765701|NCT00074802|3241691|Superiority|||||||0.018||||||Fisher's Exact Test used for analyses.|Fisher Exact|||Fisher's Exact Test used for analyses of responder status.|
1765702|NCT00074802|3241692|Superiority||Mean Difference (Net)|-5.43||||0.267|2-Sided|95.0|-15.05|4.19|||Mixed Models Analysis||||
1765703|NCT00074581|3241699|Superiority or Other||Hazard Ratio (HR)|0.31|||<|0.0001|2-Sided|95.0|0.19|0.53|||Regression, Cox||The hazard ratio estimate presented (0.31) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 69% lower risk of infection among all partner infections, during the entire study.||
1765892|NCT00070707|3241998|Superiority or Other|||||||0.413|||||||ANOVA|||Change at Final Week (PM)|
1765704|NCT00074581|3241700|Superiority or Other||Hazard Ratio (HR)|0.07|||<|0.0001|2-Sided|95.0|0.02|0.22|||Regression, Cox||The hazard ratio estimate presented (0.07) is a comparison of the early-ART arm (numerator) to the delayed-ART arm (denominator), thus indicating a 93% lower risk of infection among all linked partner infections, during the entire study.||
1765705|NCT00074412|3241711|Superiority or Other|||||||0.611|||||||Log Rank|||We compared the cumulative mortality rates, as calculated using Kaplan-Meier, between the two study groups over all 18 months of the study follow-up using a log-rank test.|
1765706|NCT00074412|3241711|Superiority or Other||Z statistic|-0.36||||0.719||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative mortality rates at 18 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z statistic.|
1765707|NCT00074412|3241711|Superiority or Other||Cumulative Mortality Rate at 6mon (%)|1.1|||||2-Sided|95.0|0.3|1.8|||||||
1765708|NCT00074412|3241711|Superiority or Other||Cumulative Mortality Rate at 6mon (%)|1.2|||||2-Sided|95.0|0.4|2.0|||||||
1765709|NCT00074412|3241711|Superiority or Other||Z statistic|-0.247||||0.805||95.0||||P-value was not adjusted for interim analysis or multiple testing|Z-test|||The cumulative rates of mortality at 6 months, as calculated by Kaplan-Meier, were compared between the two groups using a Z-statistic.|
1765710|NCT00074412|3241711|Superiority or Other||Cumulative Mortality Rate at 18mon (%)|4.1|||||2-Sided|95.0|2.7|5.6|||||||
1765711|NCT00074412|3241711|Superiority or Other||Cumulative Mortality Rate at 18mon (%)|4.7|||||2-Sided|95.0|2.0|7.4|||||||
1765712|NCT00074412|3241712|Superiority or Other||Z statistic|1.081||||0.28||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV infection at 18 months were calculated using the Kaplan-Meier method and were compared between arms using a Z statistic.|
1765713|NCT00074412|3241712|Superiority or Other||18 mon. Rate of Cum. HIV Infection (%)|3.1|||||2-Sided|95.0|1.9|4.4||||||The cumulative rate of HIV infection at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.|
1765714|NCT00074412|3241712|Superiority or Other||18 mon. Rate of Cum HIV Infection (%)|2.2|||||2-Sided|95.0|1.1|3.3||||||The cumulative rate of HIV infection at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.|
1765715|NCT00074412|3241713|Superiority or Other||Z statistic|0.988||||0.323||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV-free survival at 18 months were compared between the two groups using a Z statistic.|
1765716|NCT00074412|3241713|Superiority or Other||Cum. Rate of HIV-free Survival 18mon (%)|93.3|||||2-Sided|95.0|91.5|95.1||||||The cumulative rate of HIV-free survival at 18 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% confidence interval was calculated using Greenwood's formula.|
1765717|NCT00074412|3241713|Superiority or Other||Cum. Rate of HIV-free Survival 18mon (%)|94.5|||||2-Sided|95.0|92.9|96.2||||||The cumulative rate of HIV-free survival at 18 months in the extended NVP arm was calculated using the Kaplan-Meier method; while 95% confidence intervals were calculated using Greenwood's formula.|
1765718|NCT00074412|3241713|Superiority or Other||Z statistic|1.095||||0.274||95.0||||P-value was not adjusted for interim analysis or multiple testing.|Z-test|||The cumulative rates of HIV-free survival at 6 months were compared between the two groups using a Z-statistic.|
1765719|NCT00074412|3241713|Superiority or Other||Cum. Rate of HIV-free Survival 6mon (%)|96.8|||||2-Sided|95.0|95.5|98.0||||||The cumulative rate of HIV-free survival at 6 months in the placebo arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.|
1765720|NCT00074412|3241713|Superiority or Other||Cum. Rate of HIV-free Survival 6mon (%)|97.7|||||2-Sided|95.0|96.6|98.8||||||The cumulative rate of HIV-free survival at 6 months in the extended NVP arm was calculated using the Kaplan-Meier method; while the 95% CI was calculated using Greenwood's formula.|
1765721|NCT00074412|3241715|Superiority or Other||Z statistic|1.973||||0.049||95.0||||P-value has not been adjusted for interim analysis or multiple testing. A priori threshold for statistical significance was 0.05.|Z-test|||Assuming the cumulative HIV infection rate in placebo group would be 4.2% (2.6 at 6 wk. & 6.7 at 6 mon.), we estimated 1500 mother/infant pairs would provide 90% power to detect a reduction in HIV infection from 4.2% to 1.4% at 6 mon. with a Pearson χ² test statistic and a one-sided false positive error rate of 0.025. Rate of cumulative infection was calculated using Kaplan-Meier method and rates between extended NVP group and placebo were done with the Z statistic.|
1765722|NCT00074412|3241715|Superiority or Other||6 month Rate of Cum. HIV Infection (%)|2.4|||||2-Sided|95.0|1.3|3.6|||||||
1765723|NCT00074412|3241715|Superiority or Other||6 month Rate of Cum. HIV Infection (%)|1.1|||||2-Sided|95.0|0.3|1.8|||||||
1765724|NCT00073528|3241802|Superiority or Other||Hazard Ratio (HR)|0.71||||0.019|2-Sided|95.0|0.53|0.96||p-value is from stratified log-rank test, stratifying for site of disease and time since prior adjuvant endocrine therapy at screening|Log Rank||The estimate of the treatment Hazard Ratio was based on the log-rank test.||
1765725|NCT00073528|3241803|Superiority or Other||Hazard Ratio (HR)|0.71||||0.019|2-Sided|95.0|0.53|0.96||p-value is from stratified log-rank test, stratifying for site of disease and time since prior adjuvant endocrine therapy at screening|Log Rank||The estimate of the treatment Hazard Ratio wase based on the log-rank test.||
1765726|NCT00073307|3241807|Superiority or Other|||||||0.83|||||||random coefficient model|Random coefficient model adjusted for baseline Motzer score, baseline PWB score and relative day of PWB completion.||Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05|
1765727|NCT00073307|3241808|Superiority or Other|||||||0.98|||||||random coefficient model|Random coefficient model adjusted for baseline Motzer score, baseline FKSI-10 score and relative day of FKSI-10 completion.||Approximately 200 subjects per group, assuming a 10% drop out rate, were required to detect a 2 point difference between sorafenib and placebo at approximately 80% power with a two-sided alpha of 0.05|
1765728|NCT00073307|3241809|Superiority or Other||Difference in response rates (CR+PR)|-2.1||||||95.0|-3.7|-0.6|||||difference in response rates (CR+PR) = Placebo - Sorafenib||
1765893|NCT00070707|3241998|Superiority or Other|||||||0.579|||||||ANOVA|||Change at Week 4 (PM)|
1765729|NCT00073307|3241810|Superiority or Other||Hazard Ratio (HR)|0.44|||<|1e-06||95.0|0.35|0.55|||Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|The planned final PFS analysis was to be performed when approximately 363 progressions or deaths (if death occurred before progression) were observed. The analysis had power of 90% to detect a 50% increase in PFS using a two-sided alpha of 0.01|
1765730|NCT00073307|3241811|Superiority or Other||Hazard Ratio (HR)|0.78||||0.0287||95.0|0.62|0.97||According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).|Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.|
1765731|NCT00073307|3241812|Superiority or Other||Hazard Ratio (HR)|0.88||||0.146||95.0|0.74|1.04||According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).|Log Rank||Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category|Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.|
1765732|NCT00073021|3241821|Superiority or Other||Difference in Success Rates|9.75||||0.1173|2-Sided|95.0|-2.39|21.89|||Chi-squared||||
1765733|NCT00073021|3241822|Superiority or Other||Difference in Success Rates|11.1||||0.0966|2-Sided|95.0|-1.87|24.14|||Chi-squared||||
1765734|NCT00073021|3241823|Superiority or Other||||||<|0.0001||||||Compared to baseline|t-test, 2 sided||||
1765735|NCT00073021|3241823|Superiority or Other||||||<|0.0001||||||Compared to baseline|t-test, 2 sided||||
1765736|NCT00073021|3241823|Superiority or Other||||||<|0.534|||||||Wilcoxon (Mann-Whitney)||||
1765737|NCT00073021|3241824|Superiority or Other||||||<|0.0001||||||Compared to baseline.|t-test, 2 sided||||
1765738|NCT00073021|3241824|Superiority or Other||||||<|0.0001||||||Compared to baseline|t-test, 2 sided||||
1765739|NCT00073021|3241824|Superiority or Other||||||<|0.8308|||||||Wilcoxon (Mann-Whitney)||||
1765740|NCT00073021|3241825|Superiority or Other||Difference in Success Rates|9.73||||0.0758|2-Sided|95.0|-0.94|20.4|||Chi-squared||||
1765741|NCT00073021|3241826|Superiority or Other||Difference in Success Rates|-0.96||||0.8859|2-Sided|95.0|-14.09|12.17|||Chi-squared||||
1765742|NCT00073021|3241827|Superiority or Other||Difference in Success Rates|1.05||||0.8542|2-Sided|95.0|-10.19|12.29|||Chi-squared||||
1765743|NCT00073021|3241828|Superiority or Other||Difference in Success Rates|2.74||||0.6543|2-Sided|95.0|-9.25|14.73|||Chi-squared||||
1765744|NCT00073021|3241829|Superiority or Other||Difference in Success Rates|6.19||||0.2991|2-Sided|95.0|-5.47|17.86|||Chi-squared||||
1765745|NCT00073021|3241830|Superiority or Other||Difference in Success Rates|3.75||||0.5774|2-Sided|95.0|-9.43|16.93|||Chi-squared||||
1765746|NCT00073021|3241831|Superiority or Other||||||<|0.0001||||||Compared to baseline|t-test, 2 sided|Teh 2-sample t-test will be used to examine the treatment effect.|||
1765747|NCT00073021|3241831|Superiority or Other||||||<|0.0001||||||Compared to baseline|t-test, 2 sided|The 2-sample t-test will be used to examine the treatment effect.|||
1765748|NCT00073021|3241831|Superiority or Other||Difference Between Means|-0.5|||<|0.1594|2-Sided|95.0|-1.28|0.21|||ANOVA||||
1765749|NCT00073021|3241832|Superiority or Other||Difference in Success Rates|12.543||||0.0357|2-Sided|95.0|0.96|24.12|||Chi-squared|||It was assumed that true rate of improvement for 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with 2-sided test, type I error of 0.05 (alpha = 0.05), and power of 80%, 120 patients with moderately active ulcerative colitis were required per group to complete the study.|
1765750|NCT00073008|3241842|Superiority or Other||Kaplan-Meier estimate|18.3||||||95.0|3.9|32.6|||||Percentage of surviving participants who were progression free 4 months after the date of randomization||
1765751|NCT00073008|3241842|Superiority or Other||Kaplan-Meier estimate|27.1||||||95.0|11.9|42.3|||||Percentage of surviving participants who were progression free 4 months after the date of randomization||
1765752|NCT00073008|3241843|Superiority or Other||Kaplan-Meier estimate|19.7||||||95.0|2.9|36.4|||||Percentage of surviving participants who were progression free 4 months after the date of randomization||
1765753|NCT00073008|3241843|Superiority or Other||Kaplan-Meier estimate|34.5||||||95.0|13.7|55.4|||||Percentage of surviving participants who were progression free 4 months after the date of randomization||
1765754|NCT00072293|3241863|Superiority or Other||Hazard Ratio (HR)|0.89||||0.73|2-Sided|90.0|0.52|1.54|||Log Rank||Hazard Ratio is no axillary dissection/axillary dissection.||
1765755|NCT00072293|3241864|Non-Inferiority or Equivalence|As originally designed, target accrual was 1960 patients with analysis planned after 558 events. These targets were based on having 90% power to detect non-inferiority of no axillary dissection with a one-sided statistical signifi cance level of 10% (ie, α=0·10) under the assumption that 5-year disease-free survival with axillary dissection was 70% and defining non-inferiority as a hazard ratio (HR) of less than 1·25 (no axillary dissection relative to axillary dissection).|Hazard Ratio (HR)|0.78||||0.004|2-Sided|95.0|0.55|1.11||Test for non-inferiority of no axillary dissection. Stratified logrank test compared groups. HR (no-AD vs AD) estimated from test statistic and variance as HR=exp([O–E]/V), compared to 1.25 in 1-sided test of non-inferiority.|1-sided non-inferiority test||Hazard Ratio is no axillary dissection/axillary dissection.||
1765756|NCT00071981|3241871|Superiority or Other|||||||0.532|||||||Log Rank|||Compare overall survival curves among four arms.|
1765894|NCT00070707|3241998|Superiority or Other|||||||0.603|||||||ANOVA|||Change at Week 3 (PM)|
1765895|NCT00070707|3241998|Superiority or Other|||||||0.693|||||||ANOVA|||Change at Week 2 (PM)|
1765758|NCT00071981|3241873|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Compare HTL response rate to tetanus peptide among four arms. The null hypothesis is that HTL response is same in all four arms. Alternative hypothesis is that HTL response rate is different in at least one arm compared to other arms.|
1765759|NCT00071981|3241874|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Compare HTL response rate to 6MHP among four arms. The null hypothesis is that HTL response is same in all four arms. Alternative hypothesis is that HTL response rate is different in at least one arm compared to other arms.|
1765760|NCT00071981|3241875|Superiority or Other||||||<|0.001|||||||Fisher Exact|||Compare CTL response rate among four arms. The null hypothesis is that CTL response is same in all four arms. Alternative hypothesis is that CTL response rate is different in at least one arm compared to other arms.|
1765761|NCT00071812|3241884|Superiority or Other|||||||0.8707||||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.|
1765762|NCT00071812|3241884|Superiority or Other|||||||0.2561||||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.|
1765763|NCT00071812|3241884|Superiority or Other|||||||0.194||||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.|
1765764|NCT00071812|3241885|Superiority or Other|||||||0.0109||||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.|
1765765|NCT00071812|3241885|Superiority or Other|||||||0.2859||||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.|
1765766|NCT00071812|3241885|Superiority or Other|||||||0.096||||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.|
1765767|NCT00071812|3241886|Superiority or Other|||||||0.0051||||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.|
1765768|NCT00071812|3241886|Superiority or Other|||||||0.7864||||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.|
1765769|NCT00071812|3241886|Superiority or Other|||||||0.0958||||||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using last observation carried forward (LOCF) imputation.|
1765770|NCT00071812|3241889|Superiority or Other|||||||0.4308||||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.|
1765771|NCT00071812|3241889|Superiority or Other|||||||0.344||||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.|
1765772|NCT00071812|3241889|Superiority or Other|||||||0.1752||||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.|
1765773|NCT00071812|3241890|Superiority or Other||percent difference from placebo|-0.1||||0.9769|2-Sided|95.0|-5.6|5.4||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.|
1765774|NCT00071812|3241890|Superiority or Other||percent difference from placebo|-1.5||||0.5393|2-Sided|95.0|-6.3|3.3||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.|
1765775|NCT00071812|3241890|Superiority or Other||percent difference from placebo|2.7||||0.4299|2-Sided|95.0|-4.0|9.3||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.|
1765776|NCT00071812|3241891|Superiority or Other||percent difference from placebo|9.7||||0.0418|2-Sided|95.0|0.3|19.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.|
1765777|NCT00071812|3241891|Superiority or Other||percent difference from placebo|4.1||||0.3177|2-Sided|95.0|-4.0|12.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.|
1765778|NCT00071812|3241891|Superiority or Other||percent difference from placebo|5.4||||0.2074|2-Sided|95.0|-3.0|13.7||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.|
1765779|NCT00071812|3241892|Superiority or Other||percent difference from placebo|12.2||||0.0796|2-Sided|95.0|-1.3|25.8||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.|
1765780|NCT00071812|3241892|Superiority or Other||percent difference from placebo|9.4||||0.1677|2-Sided|95.0|-3.9|22.7||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.|
1765781|NCT00071812|3241892|Superiority or Other||percent difference from placebo|18.8||||0.0097|2-Sided|95.0|4.8|32.8||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.|
1765782|NCT00071799|3241894|Superiority or Other (legacy)||Hazard Ratio (HR)|0.5|||<|0.0001|2-Sided|95.0|0.35|0.7|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.||
1765783|NCT00071799|3241894|Superiority or Other (legacy)||||||<|0.0001||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank||||
1765784|NCT00071799|3241896|Superiority or Other (legacy)||Risk Ratio (RR)|0.67||||0.1327|2-Sided|95.0|0.35|1.2|||exact binomial||||
1765785|NCT00071799|3241897|Superiority or Other (legacy)|||||||0.0002||||||The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.|Log Rank||||
1765786|NCT00071799|3241898|Superiority or Other (legacy)||Hazard Ratio (HR)|0.73||||0.0474|2-Sided|95.0|0.53|1.0|||Regression, Cox||||
1765787|NCT00071799|3241898|Superiority or Other (legacy)|||||||0.0466||||||The p value is two-sided from the log rank test which compares whether the azacitidine and control group follow the same duration curve.|Log Rank||||
1765788|NCT00071799|3241899|Superiority or Other (legacy)|||||||0.176|||||||Fisher Exact|||Neutrophil Response - Minor|
1765789|NCT00071799|3241899|Superiority or Other (legacy)|||||||0.8695|||||||Fisher Exact|||Neutrophil Response - Major|
1765790|NCT00071799|3241899|Superiority or Other (legacy)|||||||0.7514|||||||Fisher Exact|||Platelet Response - Minor|
1765791|NCT00071799|3241899|Superiority or Other (legacy)|||||||0.0003|||||||Fisher Exact|||Platelet Response - Major|
1765792|NCT00071799|3241899|Superiority or Other (legacy)|||||||0.6203|||||||Fisher Exact|||Erythroid Response - Minor|
1765793|NCT00071799|3241899|Superiority or Other (legacy)||||||<|0.0001|||||||Fisher Exact|||Erythroid Response - Major|
1765794|NCT00071799|3241899|Superiority or Other (legacy)||||||<|0.0001|||||||Fisher Exact|||Any Improvement|
1765795|NCT00071799|3241900|Superiority or Other (legacy)|||||||0.3297|||||||Fisher Exact|||Stable Disease|
1765796|NCT00071799|3241900|Superiority or Other (legacy)|||||||0.0094|||||||Fisher Exact|||Partial Remission|
1765797|NCT00071799|3241900|Superiority or Other (legacy)|||||||0.015|||||||Fisher Exact|||Complete remission|
1765798|NCT00071799|3241900|Superiority or Other (legacy)|||||||0.0001|||||||Fisher Exact|||Overall (Complete + Partial Remission)|
1765799|NCT00071799|3241901|Superiority or Other (legacy)||||||<|0.0001|||||||Fisher Exact|||The p value is from Fisher’s exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion independent at baseline and remained transfusion independent during the on-treatment period.|
1765800|NCT00071799|3241902|Superiority or Other (legacy)|||||||1|||||||Fisher Exact|||The p value is from Fisher’s exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period|
1765801|NCT00071799|3241903|Superiority or Other (legacy)|||||||0.0005|||||||Fisher Exact|||The p value is from Fisher’s exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion independent at baseline and remained transfusion independent during the on-treatment period.|
1765802|NCT00071799|3241904|Superiority or Other (legacy)||||||<|0.0001|||||||Fisher Exact|||The p value is from Fisher’s exact test comparing the difference in the azacitidine group and the combined group of CCR regimens among patients who were transfusion dependent at baseline and transfusion independent during the on-treatment period.|
1765803|NCT00071799|3241905|Superiority or Other (legacy)||Hazard Ratio (HR)|0.83||||0.2562|2-Sided|95.0|0.6|1.15|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.||
1765804|NCT00071799|3241905|Superiority or Other (legacy)|||||||0.2555||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank||||
1765805|NCT00071799|3241906|Superiority or Other (legacy)||Hazard Ratio (HR)|0.68||||0.0027|2-Sided|95.0|0.53|0.87|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.||
1765806|NCT00071799|3241906|Superiority or Other (legacy)|||||||0.0025||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.|Log Rank||||
1765807|NCT00071799|3241907|Superiority or Other (legacy)|||||||0.002||||||"95% CI ranges are added here.~Azacitidine: low range of 15.0 months and high range of 'does not exist'.~Conventional Care: low range of 9.0 and high range of 17.0 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification||IPSS: High All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.|
1765896|NCT00070707|3241998|Superiority or Other|||||||0.362|||||||ANOVA|||Change at Week 1 (PM)|
1765897|NCT00070707|3241998|Superiority or Other|||||||0.096|||||||ANOVA|||Baseline (PM)|
1765898|NCT00070707|3241998|Superiority or Other|||||||0.838|||||||ANOVA|||Change at Final Week (AM)|
1765808|NCT00071799|3241907|Superiority or Other (legacy)|||||||0.103||||||"95% CI ranges are added here.~Azacitidine: low range of 17.1 months and high range of 'does not exist'.~Conventional Care: low range of 8.7 and high range of 24.1 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||IPSS: Intermediate 2 All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.|
1765809|NCT00071799|3241907|Superiority or Other (legacy)|||||||0.0017||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: Other~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 15.6 months and high range of 'does not exist'.~Conventional Care: low range of 11.1 and high range of 17.5 months."|
1765810|NCT00071799|3241907|Superiority or Other (legacy)|||||||0.0692||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: RAEB-2~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 15.9 months and high range of 'does not exist'.~Conventional Care: low range of 8.8 and high range of 19.4 months."|
1765811|NCT00071799|3241907|Superiority or Other (legacy)|||||||0.1679||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"WHO: RAEB 1. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 6.6 months and high range of 'does not exist'.~Conventional Care: low range of 1.8 and high range of 9.8 months."|
1765812|NCT00071799|3241907|Superiority or Other (legacy)|||||||0.0322||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"FAB: RAEB in transformation~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 11.7 months and high range of 'does not exist'.~Conventional Care: low range of 9.4 and high range of 17.0 months."|
1765813|NCT00071799|3241907|Superiority or Other (legacy)|||||||0.0056||||||"95% CI ranges are added here.~Azacitidine: low range of 21.1 months and high range of 'does not exist'.~Conventional Care: low range of 9.3 and high range of 21.9 months."|Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||FAB: Refractory anemia with excess blasts (RAEB). All patients were stratified at randomization by FAB classification and IPSS score as determined by the investigator using centrally read bone marrow and cytogenetic data. Subsequently, the FAB classifications and IPSS scores were reviewed by an Independent Review Committee (IRC). The subgroup analyses presented by FAB and IPSS represent the FAB classification and IPSS scores as determined by the IRC.|
1765814|NCT00071799|3241907|Superiority or Other (legacy)|||||||0.0469||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Gender: Female~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 13.0 months and high range of 'does not exist'.~Conventional Care: low range of 8.2 and high range of 17.6 months."|
1765815|NCT00071799|3241907|Superiority or Other (legacy)|||||||0.0042||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Gender: Male~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 17.9 months and high range of 'does not exist'.~Conventional Care: low range of 10.8 and high range of 17.2 months."|
1765816|NCT00071799|3241907|Superiority or Other (legacy)|||||||0.0707||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age >= 75 years. The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 1.7 months and high range of 15.0 months.~Conventional Care: low range of 4.1 and high range of 7.6 months."|
1765817|NCT00071799|3241907|Superiority or Other (legacy)||||||<|0.0001||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age >= 65 years~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 17.1 months and high range of 34.7 months.~Conventional Care: low range of 8.8 and high range of 16.4 months."|
1765818|NCT00071799|3241907|Superiority or Other (legacy)||||||<|0.3973||||||The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification|Log Rank|||"Age < 65 years The Kaplan-Meier median time to death was not reached due to a small number of events, so the KM 25th percentile survival time is presented.~Some of the values in outcome table #2 do not have 95% CI values so no 95% CI ranges are contained in the table. Those 95% CI ranges are added here.~Azacitidine: low range of 7.1 months and high range of 15.6 months.~Conventional Care: low range of 4.4 and high range of 12.4 months."|
1765819|NCT00071799|3241908|Superiority or Other (legacy)||Hazard Ratio (HR)|0.58||||0.0002|2-Sided|95.0|0.43|0.77|||Regression, Cox||Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.||
1765899|NCT00070707|3241998|Superiority or Other|||||||0.44|||||||ANOVA|||Change at Week 4 (AM)|
1765900|NCT00070707|3241998|Superiority or Other|||||||0.183|||||||ANOVA|||Change at Week 3 (AM)|
1765901|NCT00070707|3241998|Superiority or Other|||||||0.961|||||||ANOVA|||Change at Week 2 (AM)|
1765820|NCT00071799|3241908|Superiority or Other (legacy)|||||||0.0001|||||||Log Rank|The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.||"A 95% CI range value of 'does not exist' is not accommodated in the results table, so all the 95% CI range values are offered here.~Azacitidine: low range of 17.9 months and high range of 'does not exist'.~Conventional Care: low range of 9.8 and high range of 17.0 months."|
1765821|NCT00071890|3241910|Superiority or Other|||||||0.069||||||Biphasic decline of CD4 after week 24 : first slope before W32 and weaker decline until W168.Slopes significantly different (all p values ≤0.0001) between the 2 groups, more pronounced in the IL-2 groups|Wilcoxon (Mann-Whitney)||||
1765822|NCT00071890|3241911|Superiority or Other|||||||0.025|||||||Chi-squared||||
1765823|NCT00071721|3241952|Superiority or Other||Cox Proportional Hazard|0.958||||0.88||95.0|||||Cox Proportional Hazards||||
1765824|NCT00071513|3241954|Superiority or Other||||||<|0.01|||||||t-test, 2 sided|||A secondary hypothesis of the study was that attachment to school and/or perceptions of school supportiveness would mediate the effect of the HSTS intervention on depressive symptoms.|
1765825|NCT00071513|3241954|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Mean changes in Short Moods and Feelings measure of depression was the unit of analysis.|
1765826|NCT00071487|3241956|Superiority or Other||percent difference from placebo|17.7||||0.0882|2-Sided|95.0|-2.5|37.9||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.|
1765827|NCT00071487|3241956|Superiority or Other||percent difference from placebo|4.4||||0.6669|2-Sided|95.0|-15.5|24.2||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.|
1765828|NCT00071487|3241956|Superiority or Other||percent difference from placebo|-7.1||||0.4355|2-Sided|95.0|-24.7|10.6||P-value was not adjusted for multiple testing.|Likelihood ratio chi-squared|||Patients who dropped out or had missing data were considered failures.|
1765829|NCT00071487|3241957|Superiority or Other|||||||0.2273||||||P-value was not adjusted for multiple testing.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).|
1765830|NCT00071487|3241957|Superiority or Other|||||||0.7593||||||P-value was not adjusted for multiple testing.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).|
1765831|NCT00071487|3241957|Superiority or Other|||||||0.5615||||||P-value was not adjusted for multiple comparisons.|Log Rank|||Missing data for BILAG were handled as described previously for SELENA SLEDAI (SLE Flare Index).|
1765832|NCT00071487|3241958|Superiority or Other||Mean Difference (Final Values)|-12.7||||0.466|2-Sided|95.0|-46.9|21.5||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.|
1765833|NCT00071487|3241958|Superiority or Other||Mean Difference (Final Values)|-14.9||||0.3332|2-Sided|95.0|-45.3|15.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.|
1765834|NCT00071487|3241958|Superiority or Other||Mean Difference (Final Values)|-4.8||||0.7822|2-Sided|95.0|-38.6|29.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.|
1765835|NCT00071487|3241959|Superiority or Other||Mean Difference (Final Values)|-2.8||||0.6406|2-Sided|95.0|-14.8|9.1|||t-test, 2 sided|P-value was not adjusted for multiple testing.||Missing data for BILAG were handled as described previously for SELENA SLEDAI.|
1765836|NCT00071487|3241959|Superiority or Other||Mean Difference (Final Values)|-7.4||||0.1774|2-Sided|95.0|-18.2|3.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.|
1765837|NCT00071487|3241959|Superiority or Other||Mean Difference (Final Values)|-1.7||||0.7823|2-Sided|95.0|-13.8|10.4||P-value was not adjusted for multiple testing|t-test, 2 sided|||Missing data for BILAG were handled as described previously for SELENA SLEDAI.|
1765838|NCT00071487|3241960|Superiority or Other||Mean Difference (Final Values)|-30.41||||0.1131|2-Sided|95.0|-68.1|7.3||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.|
1765839|NCT00071487|3241960|Superiority or Other||Mean Difference (Final Values)|2.98||||0.8807|2-Sided|95.0|-36.2|42.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation.|
1765840|NCT00071487|3241960|Superiority or Other||Mean Difference (Final Values)|-28.6||||0.1287|2-Sided|95.0|-65.6|8.4||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.|
1765841|NCT00071487|3241961|Superiority or Other||Mean Difference (Final Values)|-7.4||||0.332|2-Sided|95.0|-22.2|7.5||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.|
1765842|NCT00071487|3241961|Superiority or Other||Mean Difference (Final Values)|-3.3||||0.7112|2-Sided|95.0|-20.9|14.3||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.|
1765843|NCT00071487|3241961|Superiority or Other||Mean Difference (Final Values)|-9.1||||0.1763|2-Sided|95.0|-22.4|4.1||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.|
1765844|NCT00071487|3241962|Superiority or Other|||||||0.9705||||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.|
1765845|NCT00071487|3241962|Superiority or Other|||||||0.8536||||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.|
1765846|NCT00071487|3241962|Superiority or Other|||||||0.6423||||||P-value was not adjusted for multiple testing.|Log Rank|||Patients who required protocol-prohibited medications were considered to have a flare on the date the prohibited medication was started or date of the first flare, whichever came first. Patients who withdrew from the study for reasons other than SLE disease manifestations or hospitalization related to SLE or who missed 2 or more consecutive visits were censored at the time of the last assessment.|
1765847|NCT00071487|3241963|Superiority or Other||Mean Difference (Final Values)|-6.5||||0.3296|2-Sided|95.0|-19.6|6.6||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.|
1765848|NCT00071487|3241963|Superiority or Other||Mean Difference (Final Values)|5.9||||0.4244|2-Sided|95.0|-8.7|20.6||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using LOCF imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.|
1765849|NCT00071487|3241963|Superiority or Other||Mean Difference (Final Values)|-6.1||||0.3677|2-Sided|95.0|-19.4|7.2||P-value was not adjusted for multiple testing.|t-test, 2 sided|||Missing data was handled by using a last observation carried forward (LOCF) imputation. If patient required a protocol-prohibited medication, the SELENA SLEDAI score of the last visit prior to the use of the prohibited medication was used.|
1765850|NCT00071110|3241965|Superiority or Other|||||||0.17||||||Statistic (t): 1.40|t-test, 2 sided||||
1765851|NCT00071110|3241966|Superiority or Other|||||||0.09||||||Statistic (t): 1.56|t-test, 2 sided||||
1765852|NCT00071110|3241967|Superiority or Other|||||||0.32||||||Statistic (t): -1.00|t-test, 2 sided||||
1765853|NCT00071032|3241976|Superiority or Other||Risk Difference (RD)|-0.9|||||2-Sided|99.0|-3.3|1.6|||||Liberal Arm (numerator) compared to Restrictive Arm (denominator)||
1765854|NCT00071032|3241977|Superiority or Other||Odds Ratio (OR)|1.01|||||2-Sided|95.0|0.84|1.22|||||Liberal Arm (numerator) compared to Restrictive Arm (denominator)||
1765855|NCT00070707|3241989|Superiority or Other|||||||0.154|||||||Cochran-Mantel-Haenszel|Stratified by center||SAR Nasal Symptoms: Day 29|
1765856|NCT00070707|3241989|Superiority or Other|||||||0.268|||||||Cochran-Mantel-Haenszel|Stratified by center||SAR Nasal Symptoms: Day 15|
1765857|NCT00070707|3241990|Superiority or Other|||||||0.295|||||||Cochran-Mantel-Haenszel|Stratified by center||Asthma Symptoms: Day 29|
1765858|NCT00070707|3241990|Superiority or Other|||||||0.954|||||||Cochran-Mantel-Haenszel|Stratified by center||Asthma Symptoms: Day 15|
1765859|NCT00070707|3241991|Superiority or Other|||||||0.725|||||||ANOVA|||Change at Final Week|
1765860|NCT00070707|3241991|Superiority or Other|||||||0.505|||||||ANOVA|||Change at Week 4|
1765861|NCT00070707|3241991|Superiority or Other|||||||0.167|||||||ANOVA|||Change at Week 3|
1765862|NCT00070707|3241991|Superiority or Other|||||||0.386|||||||ANOVA|||Change at Week 2|
1765863|NCT00070707|3241991|Superiority or Other|||||||0.262|||||||ANOVA|||Change at Week 1|
1765864|NCT00070707|3241991|Superiority or Other|||||||0.363|||||||ANOVA|||Baseline|
1765865|NCT00070707|3241992|Superiority or Other|||||||0.994|||||||ANOVA|||Change at Final Week|
1765866|NCT00070707|3241992|Superiority or Other|||||||0.775|||||||ANOVA|||Change at Week 4|
1765867|NCT00070707|3241992|Superiority or Other|||||||0.22|||||||ANOVA|||Change at Week 3|
1765868|NCT00070707|3241992|Superiority or Other|||||||0.458|||||||ANOVA|||Change at Week 2|
1765869|NCT00070707|3241992|Superiority or Other|||||||0.656|||||||ANOVA|||Change at Week 1|
1765870|NCT00070707|3241992|Superiority or Other|||||||0.667|||||||ANOVA|||Baseline|
1765871|NCT00070707|3241993|Superiority or Other|||||||0.136|||||||ANOVA|||Change at Final Week|
1765872|NCT00070707|3241993|Superiority or Other|||||||0.211|||||||ANOVA|||Change at Week 4|
1765873|NCT00070707|3241993|Superiority or Other|||||||0.79|||||||ANOVA|||Change at Week 3|
1765874|NCT00070707|3241993|Superiority or Other|||||||0.288|||||||ANOVA|||Change at Week 2|
1765875|NCT00070707|3241993|Superiority or Other|||||||0.025|||||||ANOVA|||Change at Week 1|
1765876|NCT00070707|3241993|Superiority or Other|||||||0.865|||||||ANOVA|||Baseline|
1765877|NCT00070707|3241994|Superiority or Other|||||||0.67|||||||ANOVA|||Change at Final Week|
1765878|NCT00070707|3241994|Superiority or Other|||||||0.696|||||||ANOVA|||Change at Week 4|
1765879|NCT00070707|3241994|Superiority or Other|||||||0.242|||||||ANOVA|||Change at Week 3|
1765880|NCT00070707|3241994|Superiority or Other|||||||0.597|||||||ANOVA|||Change at Week 2|
1765881|NCT00070707|3241994|Superiority or Other|||||||0.71|||||||ANOVA|||Change at Week 1|
1765882|NCT00070707|3241994|Superiority or Other|||||||0.375|||||||ANOVA|||Baseline|
1765883|NCT00070707|3241995|Superiority or Other|||||||0.199|||||||ANOVA|||Change at Day 29|
1765884|NCT00070707|3241995|Superiority or Other|||||||0.202|||||||ANOVA|||Change at Day 15|
1765885|NCT00070707|3241995|Superiority or Other|||||||0.823|||||||ANOVA|||Baseline|
1765886|NCT00070707|3241996|Superiority or Other|||||||0.915|||||||ANOVA|||Change at Day 29|
1765887|NCT00070707|3241996|Superiority or Other|||||||0.818|||||||ANOVA|||Change at Day 15|
1765888|NCT00070707|3241996|Superiority or Other|||||||0.693|||||||ANOVA|||Baseline|
1765889|NCT00070707|3241997|Superiority or Other|||||||0.675|||||||ANOVA|||Change at Day 29|
1765890|NCT00070707|3241997|Superiority or Other|||||||0.744|||||||ANOVA|||Change at Day 15|
1765891|NCT00070707|3241997|Superiority or Other|||||||0.823|||||||ANOVA|||Baseline|
1765912|NCT00070707|3241999|Superiority or Other|Change at Week 3 (AM)||||||0.104|||||||ANOVA||||
1765913|NCT00070707|3241999|Superiority or Other|Change at Week 2 (AM)||||||0.202|||||||ANOVA||||
1765914|NCT00070707|3241999|Superiority or Other|||||||0.25|||||||ANOVA|||Change at Week 1 (AM)|
1765915|NCT00070707|3241999|Superiority or Other|||||||0.745|||||||ANOVA|||Baseline (AM)|
1765916|NCT00070707|3242000|Superiority or Other|||||||0.231|||||||ANOVA|||Change at Final Week (PM)|
1765917|NCT00070707|3242000|Superiority or Other|||||||0.149|||||||ANOVA|||Change at Week 4 (PM)|
1765918|NCT00070707|3242000|Superiority or Other|||||||0.018|||||||ANOVA|||Change at Week 3 (PM)|
1765919|NCT00070707|3242000|Superiority or Other|||||||0.019|||||||ANOVA|||Change at Week 2 (PM)|
1765920|NCT00070707|3242000|Superiority or Other|||||||0.237|||||||ANOVA|||Change at Week 1 (PM)|
1765921|NCT00070707|3242000|Superiority or Other|||||||0.17|||||||ANOVA|||Baseline (PM)|
1765922|NCT00070707|3242000|Superiority or Other|||||||0.036|||||||ANOVA|||Change at Final Week (AM)|
1765923|NCT00070707|3242000|Superiority or Other|||||||0.041|||||||ANOVA|||Change at Week 4 (AM)|
1765924|NCT00070707|3242000|Superiority or Other|||||||0.001|||||||ANOVA|||Change at Week 3 (AM)|
1765925|NCT00070707|3242000|Superiority or Other|||||||0.004|||||||ANOVA|||Change at Week 2 (AM)|
1765926|NCT00070707|3242000|Superiority or Other|||||||0.014|||||||ANOVA|||Change at Week 1 (AM)|
1765927|NCT00070707|3242000|Superiority or Other|||||||0.089|||||||ANOVA|||Baseline (AM)|
1765928|NCT00070707|3242001|Superiority or Other|||||||0.173|||||||ANOVA|||Change at Final Week (PM)|
1765929|NCT00070707|3242001|Superiority or Other|||||||0.113|||||||ANOVA|||Change at Week 4 (PM)|
1765930|NCT00070707|3242001|Superiority or Other|||||||0.016|||||||ANOVA|||Change at Week 3 (PM)|
1765931|NCT00070707|3242001|Superiority or Other|||||||0.009|||||||ANOVA|||Change at Week 2 (PM)|
1765932|NCT00070707|3242001|Superiority or Other|||||||0.148|||||||ANOVA|||Change at Week 1 (PM)|
1765933|NCT00070707|3242001|Superiority or Other|||||||0.373|||||||ANOVA|||Baseline (PM)|
1765934|NCT00070707|3242001|Superiority or Other|||||||0.069|||||||ANOVA|||Change at Final Week (AM)|
1765935|NCT00070707|3242001|Superiority or Other|||||||0.027|||||||ANOVA|||Change at Week 4 (AM)|
1765936|NCT00070707|3242001|Superiority or Other|||||||0.002|||||||ANOVA|||Change at Week 3 (AM)|
1765937|NCT00070707|3242001|Superiority or Other|||||||0.004|||||||ANOVA|||Change at Week 2 (AM)|
1765938|NCT00070707|3242001|Superiority or Other|||||||0.014|||||||ANOVA|||Change at Week 1 (AM)|
1765939|NCT00070707|3242001|Superiority or Other|||||||0.181|||||||ANOVA|||Baseline (AM)|
1765940|NCT00070707|3242002|Superiority or Other|||||||0.043|||||||ANOVA|||Change at Final Week (PM)|
1765941|NCT00070707|3242002|Superiority or Other|||||||0.022|||||||ANOVA|||Change at Week 4 (PM)|
1765942|NCT00070707|3242002|Superiority or Other|||||||0.026|||||||ANOVA|||Change at Week 3 (PM)|
1765943|NCT00070707|3242002|Superiority or Other|||||||0.259|||||||ANOVA|||Change at Week 2 (PM)|
1765944|NCT00070707|3242002|Superiority or Other|||||||0.426|||||||ANOVA|||Change at Week 1 (PM)|
1765945|NCT00070707|3242002|Superiority or Other|||||||0.146|||||||ANOVA|||Baseline (PM)|
1765946|NCT00070707|3242002|Superiority or Other|||||||0.037|||||||ANOVA|||Change at Final Week (AM)|
1765947|NCT00070707|3242002|Superiority or Other|||||||0.03|||||||ANOVA|||Change at Week 4 (AM)|
1765948|NCT00070707|3242002|Superiority or Other|||||||0.006|||||||ANOVA|||Change at Week 3 (AM)|
1765949|NCT00070707|3242002|Superiority or Other|||||||0.107|||||||ANOVA|||Change at Week 2 (AM)|
1765950|NCT00070707|3242002|Superiority or Other|||||||0.126|||||||ANOVA|||Change at Week 1 (AM)|
1765951|NCT00070707|3242002|Superiority or Other|||||||0.136|||||||ANOVA|||Baseline (AM)|
1765952|NCT00070707|3242003|Superiority or Other|||||||0.139|||||||ANOVA|||Change at Final Week (PM)|
1765953|NCT00070707|3242003|Superiority or Other|||||||0.1|||||||ANOVA|||Change at Week 4 (PM)|
1765954|NCT00070707|3242003|Superiority or Other|||||||0.014|||||||ANOVA|||Change at Week 3 (PM)|
1765955|NCT00070707|3242003|Superiority or Other|||||||0.05|||||||ANOVA|||Change at Week 2 (PM)|
1765956|NCT00070707|3242003|Superiority or Other|||||||0.308|||||||ANOVA|||Change at Week 1 (PM)|
1765957|NCT00070707|3242003|Superiority or Other|||||||0.269|||||||ANOVA|||Baseline (PM)|
1765958|NCT00070707|3242003|Superiority or Other|||||||0.047|||||||ANOVA|||Change at Final Week (AM)|
1765959|NCT00070707|3242003|Superiority or Other|||||||0.033|||||||ANOVA|||Change at Week 4 (AM)|
1765960|NCT00070707|3242003|Superiority or Other|||||||0.001|||||||ANOVA|||Change at Week 3 (AM)|
1765961|NCT00070707|3242003|Superiority or Other|||||||0.012|||||||ANOVA|||Change at Week 2 (AM)|
1765962|NCT00070707|3242003|Superiority or Other|||||||0.022|||||||ANOVA|||Change at Week 1 (AM)|
1765963|NCT00070707|3242003|Superiority or Other|||||||0.104|||||||ANOVA|||Baseline (AM)|
1765964|NCT00070707|3242004|Superiority or Other|Day 29||||||0.227|||||||Cochran-Mantel-Haenszel||||
1765965|NCT00070707|3242004|Superiority or Other|Day 15||||||0.739|||||||Cochran-Mantel-Haenszel||||
1765966|NCT00070707|3242004|Superiority or Other|Baseline||||||0.532|||||||Cochran-Mantel-Haenszel||||
1765967|NCT00070707|3242005|Superiority or Other|||||||0.422|||||||ANOVA|||Change at Final Week (PM)|
1765968|NCT00070707|3242005|Superiority or Other|||||||0.617|||||||ANOVA|||Change at Week 4 (PM)|
1765969|NCT00070707|3242005|Superiority or Other|||||||0.529|||||||ANOVA|||Change at Week 3 (PM)|
1765970|NCT00070707|3242005|Superiority or Other|||||||0.356|||||||ANOVA|||Change at Week 2 (PM)|
1765971|NCT00070707|3242005|Superiority or Other|||||||0.098|||||||ANOVA|||Change at Week 1 (PM)|
1765972|NCT00070707|3242005|Superiority or Other|||||||0.711|||||||ANOVA|||Baseline (PM)|
1765973|NCT00070707|3242005|Superiority or Other|||||||0.056|||||||ANOVA|||Change at Final Week (AM)|
1765974|NCT00070707|3242005|Superiority or Other|||||||0.035|||||||ANOVA|||Change at Week 4 (AM)|
1765975|NCT00070707|3242005|Superiority or Other|||||||0.149|||||||ANOVA|||Change at Week 3 (AM)|
1765976|NCT00070707|3242005|Superiority or Other|||||||0.182|||||||ANOVA|||Change at Week 2 (AM)|
1765977|NCT00070707|3242005|Superiority or Other|||||||0.038|||||||ANOVA|||Change at Week 1 (AM)|
1765978|NCT00070707|3242005|Superiority or Other|||||||0.629|||||||ANOVA|||Baseline (AM)|
1765979|NCT00070707|3242006|Superiority or Other|||||||0.819|||||||ANOVA|||Change at Final Week (PM)|
1765980|NCT00070707|3242006|Superiority or Other|||||||0.73|||||||ANOVA|||Change at Week 4 (PM)|
1765981|NCT00070707|3242006|Superiority or Other|||||||0.433|||||||ANOVA|||Change at Week 3 (PM)|
1765982|NCT00070707|3242006|Superiority or Other|||||||0.901|||||||ANOVA|||Change at Week 2 (PM)|
1765983|NCT00070707|3242006|Superiority or Other|||||||0.281|||||||ANOVA|||Change at Week 1 (PM)|
1765984|NCT00070707|3242006|Superiority or Other|||||||0.158|||||||ANOVA|||Baseline (PM)|
1765985|NCT00070707|3242006|Superiority or Other|||||||0.716|||||||ANOVA|||Change at Final Week (AM)|
1765986|NCT00070707|3242006|Superiority or Other|||||||0.802|||||||ANOVA|||Change at Week 4 (AM)|
1765987|NCT00070707|3242006|Superiority or Other|||||||0.359|||||||ANOVA|||Change at Week 3 (AM)|
1765988|NCT00070707|3242006|Superiority or Other|||||||0.945|||||||ANOVA|||Change at Week 2 (AM)|
1765989|NCT00070707|3242006|Superiority or Other|||||||0.492|||||||ANOVA|||Change at Week 1 (AM)|
1765990|NCT00070707|3242006|Superiority or Other|||||||0.078|||||||ANOVA|||Baseline (AM)|
1765991|NCT00070707|3242007|Superiority or Other|||||||0.774|||||||ANOVA|||Change at Final Week (PM)|
1765992|NCT00070707|3242007|Superiority or Other|||||||0.45|||||||ANOVA|||Change at Week 4 (PM)|
1765993|NCT00070707|3242007|Superiority or Other|||||||0.25|||||||ANOVA|||Change at Week 3 (PM)|
1765994|NCT00070707|3242007|Superiority or Other|||||||0.673|||||||ANOVA|||Change at Week 2 (PM)|
1765995|NCT00070707|3242007|Superiority or Other|||||||0.484|||||||ANOVA|||Change at Week 1 (PM)|
1765996|NCT00070707|3242007|Superiority or Other|||||||0.128|||||||ANOVA|||Baseline (PM)|
1765997|NCT00070707|3242007|Superiority or Other|||||||0.941|||||||ANOVA|||Change at Final Week (AM)|
1765998|NCT00070707|3242007|Superiority or Other|||||||0.982|||||||ANOVA|||Change at Week 4 (AM)|
1765999|NCT00070707|3242007|Superiority or Other|||||||0.289|||||||ANOVA|||Change at Week 3 (AM)|
1766000|NCT00070707|3242007|Superiority or Other|||||||0.749|||||||ANOVA|||Change at Week 2 (AM)|
1766001|NCT00070707|3242007|Superiority or Other|||||||0.116|||||||ANOVA|||Change at Week 1 (AM)|
1766002|NCT00070707|3242007|Superiority or Other|||||||0.068|||||||ANOVA|||Baseline (AM)|
1766003|NCT00070707|3242008|Superiority or Other|||||||0.461|||||||ANOVA|||Change at Final Week (PM)|
1766004|NCT00070707|3242008|Superiority or Other|||||||0.305|||||||ANOVA|||Change at Week 4 (PM)|
1766005|NCT00070707|3242008|Superiority or Other|||||||0.11|||||||ANOVA|||Change at Week 3 (PM)|
1766006|NCT00070707|3242008|Superiority or Other|||||||0.471|||||||ANOVA|||Change at Week 2 (PM)|
1766007|NCT00070707|3242008|Superiority or Other|||||||0.915|||||||ANOVA|||Change at Week 1 (PM)|
1766008|NCT00070707|3242008|Superiority or Other|||||||0.055|||||||ANOVA|||Baseline (PM)|
1766009|NCT00070707|3242008|Superiority or Other|||||||0.178|||||||ANOVA|||Change at Final Week (AM)|
1766010|NCT00070707|3242008|Superiority or Other|||||||0.21|||||||ANOVA|||Change at Week 4 (AM)|
1766011|NCT00070707|3242008|Superiority or Other|||||||0.088|||||||ANOVA|||Change at Week 3 (AM)|
1766012|NCT00070707|3242008|Superiority or Other|||||||0.483|||||||ANOVA|||Change at Week 2 (AM)|
1766013|NCT00070707|3242008|Superiority or Other|||||||0.693|||||||ANOVA|||Change at Week 1 (AM)|
1766014|NCT00070707|3242008|Superiority or Other|||||||0.023|||||||ANOVA|||Baseline (AM)|
1766015|NCT00070707|3242009|Superiority or Other|||||||0.978|||||||ANOVA|||Change at Final Week (PM)|
1766016|NCT00070707|3242009|Superiority or Other|||||||0.623|||||||ANOVA|||Change at Week 4 (PM)|
1766017|NCT00070707|3242009|Superiority or Other|||||||0.373|||||||ANOVA|||Change at Week 3 (PM)|
1766018|NCT00070707|3242009|Superiority or Other|||||||0.984|||||||ANOVA|||Change at Week 2 (PM)|
1766019|NCT00070707|3242009|Superiority or Other|||||||0.291|||||||ANOVA|||Change at Week 1 (PM)|
1766020|NCT00070707|3242009|Superiority or Other|||||||0.109|||||||ANOVA|||Baseline (PM)|
1766021|NCT00070707|3242009|Superiority or Other|||||||0.977|||||||ANOVA|||Change at Final Week (AM)|
1766022|NCT00070707|3242009|Superiority or Other|||||||0.914|||||||ANOVA|||Change at Week 4 (AM)|
1766023|NCT00070707|3242009|Superiority or Other|||||||0.487|||||||ANOVA|||Change at Week 3 (AM)|
1766024|NCT00070707|3242009|Superiority or Other|||||||0.93|||||||ANOVA|||Change at Week 2 (AM)|
1766025|NCT00070707|3242009|Superiority or Other|||||||0.168|||||||ANOVA|||Change at Week 1 (AM)|
1766026|NCT00070707|3242009|Superiority or Other|||||||0.101|||||||ANOVA|||Baseline (AM)|
1766027|NCT00070564|3242013|Superiority or Other (legacy)|||||||0.28|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.|
1766028|NCT00070564|3242013|Superiority or Other (legacy)|||||||0.4|||||||Log Rank|||Test of overall treatment differences|
1766029|NCT00070564|3242014|Superiority or Other (legacy)|||||||0.66|||||||Log Rank|||Test of interaction two treatments: AC and paclitaxel.|
1766030|NCT00070564|3242014|Superiority or Other (legacy)|||||||0.69|||||||Log Rank|||Test of overall treatment differences.|
1766031|NCT00070564|3242015|Superiority or Other (legacy)|||||||0.01|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.|
1766032|NCT00070564|3242015|Superiority or Other (legacy)|||||||0.062|||||||Log Rank|||Test of overall treatment differences.|
1766033|NCT00070564|3242016|Superiority or Other (legacy)|||||||0.018|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.|
1766034|NCT00070564|3242016|Superiority or Other (legacy)|||||||0.076|||||||Log Rank|||Test of overall treatment differences.|
1766035|NCT00070564|3242017|Superiority or Other (legacy)|||||||0.52|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.|
1766036|NCT00070564|3242017|Superiority or Other (legacy)|||||||0.9|||||||Log Rank|||Test of overall treatment differences.|
1766037|NCT00070564|3242018|Superiority or Other (legacy)|||||||0.42|||||||Log Rank|||Test of interaction of two treatments: AC and paclitaxel.|
1766038|NCT00070564|3242018|Superiority or Other (legacy)|||||||0.67|||||||Log Rank|||Overall treatment differences.|
1766039|NCT00070564|3242020|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.724|2-Sided|95.0|0.54|1.53|||Log Rank||||
1766040|NCT00070564|3242020|Superiority or Other (legacy)|||||||0.04|||||||Log Rank||||
1766041|NCT00070564|3242020|Superiority or Other (legacy)||Hazard Ratio (HR)|1.24||||0.17|2-Sided|95.0|0.91|1.68|||Log Rank||||
1766042|NCT00070564|3242020|Superiority or Other (legacy)||Hazard Ratio (HR)|1.46||||0.011|2-Sided|95.0|1.09|1.95|||Log Rank||||
1766043|NCT00070564|3242020|Superiority or Other (legacy)||Hazard Ratio (HR)|1.44||||0.013|2-Sided|95.0|1.08|1.93|||Log Rank||||
1766044|NCT00070564|3242021|Superiority or Other (legacy)||Hazard Ratio (HR)|0.93||||0.733|2-Sided|95.0|0.61|1.41|||Log Rank||||
1766045|NCT00070564|3242021|Superiority or Other (legacy)|||||||0.11|||||||Log Rank||||
1766046|NCT00070564|3242021|Superiority or Other (legacy)||Hazard Ratio (HR)|1.12||||0.38|2-Sided|95.0|0.87|1.44|||Log Rank||||
1766047|NCT00070564|3242021|Superiority or Other (legacy)||Hazard Ratio (HR)|1.24||||0.072|2-Sided|95.0|0.98|1.59|||Log Rank||||
1766048|NCT00070564|3242021|Superiority or Other (legacy)||Hazard Ratio (HR)|1.32||||0.022|2-Sided|95.0|1.04|1.68|||Log Rank||||
1766049|NCT00070499|3242023|Superiority or Other (legacy)|||||||0.29|||||||Log Rank|||Log-rank test of relapse-free survival|
1766050|NCT00070499|3242023|Superiority or Other (legacy)|||||||0.074|||||||Log Rank|||Log-rank test of relapse-free survival|
1766051|NCT00070499|3242024|Superiority or Other (legacy)|||||||0.55|||||||Log Rank|||Log-rank test of overall survival|
1766052|NCT00070499|3242024|Superiority or Other (legacy)|||||||0.29|||||||Log Rank|||Log-rank test of overall survival|
1766053|NCT00070499|3242026|Superiority or Other (legacy)|||||||0.31|||||||Fisher Exact||||
1766054|NCT00070499|3242026|Superiority or Other (legacy)|||||||0.073|||||||Fisher Exact||||
1766055|NCT00069784|3242047|Superiority or Other||Odds Ratio (OR)|0.72|||||2-Sided|95.0|0.58|0.91|||||Odds ratio estimated using Cochran-Mantel-Haenszel (CMH) test method stratified by double-blind treatment (omega-3 PUFA or placebo) and previous cardiovascular event (yes or no).||
1766056|NCT00069784|3242048|Superiority or Other||Cox Proportional Hazard|0.97|||||2-Sided|95.0|0.9|1.047|||||Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.||
1766057|NCT00069784|3242049|Superiority or Other||Cox Proportional Hazard|0.983|||||2-Sided|95.0|0.899|1.076|||||Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, with double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event as covariates.||
1766058|NCT00069784|3242050|Superiority or Other||Cox Proportional Hazard|1.038||||0.2692|2-Sided|95.0|0.972|1.109||The second coprimary outcome was tested at 1% (see above additional information for the first coprimary outcome).|Log Rank|Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|See above additional details provided for the analysis of the first coprimary outcome.|
1766059|NCT00069784|3242051|Superiority or Other||Cox Proportional Hazard|1.022||||0.6273|2-Sided|95.0|0.937|1.114||For the analysis of the two coprimary efficacy outcomes, the overall Type 1 error was partitioned. The first coprimary outcome was tested at 4.4%, whereas the second coprimary outcome was tested at 1% (weighted Hochberg procedure).|Log Rank|Log-rank test stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|Hazard ratio (glargine/standard care) estimated by Cox regression model with treatment (glargine, standard care) as factor, stratified by double-blind treatment (omega-3 PUFA, placebo), baseline diabetes diagnosis and previous CV event.|The total required number of first coprimary outcomes (2200) assumed that a hazard reduction of 14-16% was clinically significant and controlled the overall experiment-wise Type 1 error at 5% with a power of 80% for each outcome. The total number of participants needed to achieve this number of events within the planned enrollment and treatment periods was ultimately estimated to be 12 500 based on the CURE and HOPE study databases.|
1766060|NCT00069823|3242052|Superiority or Other||Mean Difference (Net)|-0.2|Standard Error of the Mean|0.3||0.39|2-Sided|95.0|-0.8|0.3|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group||
1766061|NCT00069823|3242053|Superiority or Other||Mean Difference (Net)|0.01|Standard Error of the Mean|0.03||0.76|2-Sided|95.0|-0.05|0.07|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group||
1766062|NCT00069823|3242054|Superiority or Other||Mean Difference (Net)|0.5|Standard Error of the Mean|0.78||0.56|2-Sided|95.0|-1.1|2.2|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group||
1766063|NCT00069823|3242055|Superiority or Other||Mean Difference (Net)|-0.9|Standard Error of the Mean|0.6||0.16|2-Sided|95.0|-2.0|0.4|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group||
1766064|NCT00069823|3242056|Superiority or Other||Mean Difference (Net)|-0.1|Standard Error of the Mean|0.1||0.33|2-Sided|95.0|-0.2|0.1|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group||
1766099|NCT00069576|3242097|Superiority or Other||Risk Ratio (RR)|0.49|||<|0.001|2-Sided|97.0|0.32|0.76|||Chi-squared||||
1766065|NCT00069823|3242057|Superiority or Other||Mean Difference (Final Values)|-0.02|Standard Error of the Mean|0.01||0.11|2-Sided|95.0|-0.05|-0.02|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group||
1766066|NCT00069823|3242058|Superiority or Other||Treatment Effect|0.1|Standard Error of the Mean|0.1||0.11|2-Sided|95.0|0.0|0.2|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group||
1766067|NCT00069823|3242059|Superiority or Other||Treatment Effect|-1.8||||0.04||95.0|-3.6|-0.1|||Regression, Linear||||
1766068|NCT00069823|3242060|Superiority or Other||Mean Difference (Final Values)|6.0|Standard Error of the Mean|5.1||0.24|2-Sided|95.0|-4.0|16.0|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group||
1766069|NCT00069823|3242061|Superiority or Other||Mean Difference (Final Values)|0.03|Standard Error of the Mean|0.03||0.3|2-Sided|95.0|-0.03|0.09|||Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group||
1766070|NCT00069823|3242062|Superiority or Other||Mean Difference (Net)|0.03|Standard Error of the Mean|0.03||0.36|2-Sided|95.0|-0.03|0.08||P values were calculated with the use of linear regression.|Regression, Linear||Treatment effect is the difference in mean change in the esomeprazole group minus the mean change in the placebo group, e.g. 0.00 - (-0.02) = -0.03 (rounding)|The treatment effect is the mean change in the Esomeprazole group - mean change in placebo group|
1766071|NCT00069823|3242063|Superiority or Other||Incidence-Rate Ratio|0.9||||0.7|2-Sided|95.0|0.6|1.4||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.|
1766072|NCT00069823|3242064|Superiority or Other||Incidence-Rate Ratio|0.9||||0.62||95.0|0.7|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Incidence-rate ratios and P values were estimated with the use of negative binomial regression models with robust variance estimates.|
1766073|NCT00069823|3242065|Superiority or Other||Incidence-Rate Ratio|1.0||||0.87|2-Sided|95.0|0.8|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.|
1766074|NCT00069823|3242066|Superiority or Other||Incidence-Rate Ratio|0.9||||0.62|2-Sided|95.0|0.6|1.3||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.|
1766075|NCT00069823|3242067|Superiority or Other||Incidence-Rate Ratio|1.1||||0.66|2-Sided|95.0|0.8|1.5||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||The rates of EPACs were compared using incidence-rate ratios (IRR). IRR and P value were estimated with the use of negative binomial regression models with robust variance estimates.|
1766076|NCT00069823|3242068|Superiority or Other||Incidence-Rate Ratio|0.9||||0.79|2-Sided|95.0|0.6|1.5||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.|
1766077|NCT00069823|3242069|Superiority or Other||Incidence-Rate Ratio|1.2||||0.35|2-Sided|95.0|0.8|2.0||P values are for the treatment effect of esomeprazole as compared with placebo.|Negative binomial regression|||Rates were compared with incidence-rate ratios (IRR). The IRR and P values were estimated with the use of negative binomial regression models with robust variance estimates.|
1766078|NCT00069641|3242072|Superiority or Other||Mean Difference (Net)|18.96|Standard Error of the Mean|6.47||0.0049|2-Sided|95.0|5.99|31.93|||ANCOVA|||p-value for treatment difference based on Analysis of covariance (ANCOVA) model containing treatment, region, baseline participant age, and baseline disease score.|
1766079|NCT00069576|3242077|Superiority or Other|||||||0.87|||||||Wilcoxon (Mann-Whitney)||||
1766080|NCT00069576|3242078|Superiority||Risk Ratio (RR)|0.76|||||2-Sided|95.0|0.36|1.62|||||||
1766081|NCT00069576|3242079|Superiority||Risk Ratio (RR)|1.23|||||2-Sided|95.0|0.74|2.05|||||||
1766082|NCT00069576|3242080|Superiority||Risk Ratio (RR)|1.05|||||2-Sided|95.0|0.65|1.69|||||||
1766083|NCT00069576|3242081|Superiority||Risk Ratio (RR)|0.88|||||2-Sided|95.0|0.71|1.1|||||||
1766084|NCT00069576|3242082|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766085|NCT00069576|3242083|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766086|NCT00069576|3242084|Superiority or Other||Risk Ratio (RR)|0.63||||0.01|2-Sided|97.0|0.42|0.96|||Chi-squared||||
1766087|NCT00069576|3242085|Superiority or Other||Risk Ratio (RR)|0.46||||0.02|2-Sided|97.0|0.22|0.97|||Chi-squared||||
1766088|NCT00069576|3242086|Superiority or Other||Risk Ratio (RR)|0.37||||0.02|2-Sided|97.0|0.14|0.97|||Chi-squared||||
1766089|NCT00069576|3242087|Superiority or Other||Risk Ratio (RR)|0.79||||0.02|2-Sided|97.0|0.64|0.99|||Chi-squared||||
1766090|NCT00069576|3242088|Superiority or Other||Risk Ratio (RR)|1.02||||0.86|2-Sided|97.0|0.81|1.29|||Chi-squared||||
1766091|NCT00069576|3242089|Superiority or Other||Risk Ratio (RR)|0.66||||0.33|2-Sided|97.0|0.26|1.67|||Chi-squared||||
1766092|NCT00069576|3242090|Superiority or Other||Risk Ratio (RR)|0.77||||0.32|2-Sided|97.0|0.44|1.36|||Chi-squared||||
1766093|NCT00069576|3242091|Superiority or Other||Risk Ratio (RR)|0.77||||0.19|2-Sided|97.0|0.51|1.18|||Chi-squared||||
1766094|NCT00069576|3242092|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766095|NCT00069576|3242093|Superiority or Other||Risk Ratio (RR)|1.18||||0.49|2-Sided|97.0|0.7|1.99|||Chi-squared||||
1766096|NCT00069576|3242094|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)||||
1766097|NCT00069576|3242095|Superiority or Other||Risk Ratio (RR)|0.81||||0.27|2-Sided|97.0|0.53|1.23|||Chi-squared||||
1766098|NCT00069576|3242096|Superiority or Other||Risk Ratio (RR)|0.41|||<|0.001|2-Sided|97.0|0.26|0.66|||Chi-squared||||
1766100|NCT00069576|3242098|Superiority||Risk Ratio (RR)|0.94|||||2-Sided|95.0|0.68|1.28|||||||
1766101|NCT00069576|3242099|Superiority or Other||Risk Ratio (RR)|0.48||||0.33|2-Sided|97.0|0.1|2.2|||Chi-squared|||Analysis for birth trauma|
1766102|NCT00069576|3242099|Superiority or Other||Risk Ratio (RR)|0.78||||0.07|2-Sided|97.0|0.57|1.05|||Chi-squared|||Analysis for elevated cord-blood C-peptide level|
1766103|NCT00069576|3242099|Superiority or Other||Risk Ratio (RR)|0.74||||0.12|2-Sided|97.0|0.49|1.12|||Chi-squared|||Analysis for hyperbilirubinemia|
1766104|NCT00069576|3242099|Superiority or Other||Risk Ratio (RR)|1.06||||0.75|2-Sided|97.0|0.73|1.53|||Chi-squared|||Analysis for Hypoglycemia|
1766105|NCT00069576|3242099|Superiority or Other||Risk Ratio (RR)|0.87||||0.14|2-Sided|97.0|0.72|1.07|||Chi-squared|||For Total Composite End Point|
1766106|NCT00069121|3242127|Other|Descriptive analysis only.|Hazard Ratio (HR)|0.83||||0.0367|2-Sided|95.0|0.7|0.99|||Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.||
1766107|NCT00069121|3242129|Other|Descriptive analysis only.|Hazard Ratio (HR)|0.78||||0.0015|2-Sided|95.0|0.67|0.91|||Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.||
1766108|NCT00069121|3242130|Superiority||Hazard Ratio (HR)|0.8||||0.0038|2-Sided|95.0|0.69|0.93||This test used a two-sided significance level of 5%.|Log Rank||The hazard ratio was calculated as XELOX versus 5-FU/LV arms.||
1766109|NCT00069108|3242134|Superiority or Other||Hazard Ratio (HR)|0.96|||||2-Sided|95.0|0.81|1.12|||||||
1766110|NCT00069108|3242135|Superiority or Other||Hazard Ratio (HR)|1.15|||||2-Sided|95.0|0.79|1.68|||||||
1766111|NCT00069108|3242137|Non-Inferiority or Equivalence|The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% CI of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.|Hazard Ratio (HR)|1.03|||||2-Sided|95.0|0.87|1.23|||||||
1766112|NCT00069108|3242138|Superiority or Other||Odds Ratio (OR)|1.28||||0.2911|2-Sided|95.0|0.81|2.01||p-value is for difference between response rates.|Chi-squared||||
1766113|NCT00069108|3242139|Superiority or Other||Odds Ratio (OR)|1.19||||0.4028|2-Sided|95.0|0.79|1.77||p-value is for difference between response rates.|Chi-squared||||
1766114|NCT00069108|3242140|Superiority or Other||Hazard Ratio (HR)|1.18|||||2-Sided|95.0|0.95|1.47|||||||
1766115|NCT00069108|3242141|Superiority or Other||Hazard Ratio (HR)|1.11|||||2-Sided|95.0|0.91|1.37|||||||
1766116|NCT00069108|3242142|Non-Inferiority or Equivalence|While the study was not designed to demonstrate non-inferiority in PFS based on IRC assessments the pre-specified margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population.|Hazard Ratio (HR)|0.93||||0.00223|2-Sided|95.0|0.74|1.17|||Chi-squared||The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population||
1766117|NCT00069108|3242143|Non-Inferiority or Equivalence|The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population|Hazard Ratio (HR)|1.03||||0.00584|2-Sided|95.0|0.87|1.24|||Chi-squared||The pre-specified non-inferiority margin (1.30) was compared with the upper limit of the 95% confidence interval (CI) of the hazard ratio (HR, XELOX vs FOLFOX-4) in the population||
1766118|NCT00069095|3242144|Superiority or Other||Hazard Ratio (HR)|1.2||||0.8207|2-Sided|97.5|0.2|7.05|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone [HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)] was presented.|
1766119|NCT00069095|3242145|Non-Inferiority or Equivalence|No formal statistical testing was done.|Hazard Ratio (HR)|0.35|||||2-Sided|97.5|0.09|1.39||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).|
1766120|NCT00069095|3242146|Superiority or Other||Hazard Ratio (HR)|0.82||||0.0307|2-Sided|97.5|0.66|1.01|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone [HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)] was presented.|
1766121|NCT00069095|3242147|Non-Inferiority or Equivalence|No formal statistical testing was performed for duration of overall response.|Hazard Ratio (HR)|1.02|||||2-Sided|97.5|0.86|1.22||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)|
1766122|NCT00069095|3242150|Superiority or Other||Hazard Ratio (HR)|0.81||||0.0004|2-Sided|97.5|0.7|0.92|||Log Rank|||On treatment approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone [HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)] was presented.|
1766123|NCT00069095|3242150|Superiority or Other||Hazard Ratio (HR)|0.84||||0.003|2-Sided|97.5|0.74|0.96|||Log Rank|||General approach: Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone [HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)] was presented.|
1766124|NCT00069095|3242151|Non-Inferiority or Equivalence|Fewer events were expected in analyses using the on-treatment approach than in the analyses using the general approach, thus leading to reduced power.Therefore, no formal statistical testing was performed.|Hazard Ratio (HR)|1.1|||||2-Sided|97.5|0.98|1.23||||||On-treatment Approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).|
1766125|NCT00069095|3242151|Non-Inferiority or Equivalence|No formal statistical testing was done.|Hazard Ratio (HR)|1.08|||||2-Sided|97.5|0.97|1.2||||||General approach: HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV)|
1766126|NCT00069095|3242152|Superiority or Other||Odds Ratio (OR)|1.0||||0.9887|2-Sided|97.5|0.78|1.28|||Chi-squared|||Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX 4+P/XELOX+P) </= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) > 1.0. The test used a two-sided significance level of 2.5%|
1766127|NCT00069095|3242153|Non-Inferiority or Equivalence|The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab shall be concluded if the lower limit of this confidence interval is above 0.66.|Odds Ratio (OR)|0.94|||||2-Sided|97.5|0.76|1.16||||||Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) </= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) > 0.66|
1766128|NCT00069095|3242154|Superiority or Other||Odds Ratio (OR)|0.9||||0.3091|2-Sided|97.5|0.71|1.14|||Chi-squared|||Superiority of adding bevacizumab to chemotherapy was tested as follows - H0: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) </= 1.0 versus H1: OR(FOLFOX-4+BV/XELOX+BV)/(FOLFOX-4+P/XELOX+P) > 1.0. The test used a two-sided significance level of 2.5%.|
1766129|NCT00069095|3242155|Non-Inferiority or Equivalence|The analysis was based on the two-sided 97.5% confidence interval for OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV). Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was concluded if the lower limit of this confidence interval is above 0.66.|Odds Ratio (OR)|0.89|||||2-Sided|97.5|0.72|1.09||||||Non-inferiority of XELOX with/without bevacizumab to FOLFOX-4 with/without bevacizumab was tested by the pair of hypotheses - H0: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) </= 0.66 versus H1: OR(XELOX/XELOX+P/XELOX+BV)/(FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV) > 0.66, where OR denotes Odds ratio.|
1766130|NCT00069095|3242156|Superiority or Other||Hazard Ratio (HR)|0.83||||0.0023|2-Sided|97.5|0.72|0.95|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone [HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)] was presented.|
1766131|NCT00069095|3242157|Superiority or Other||Hazard Ratio (HR)|0.89||||0.1921|2-Sided|97.5|0.72|1.09|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone [HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)] was presented together with the 97.5% confidence interval.|
1766132|NCT00069095|3242158|Non-Inferiority or Equivalence|This study was not powered for testing non-inferiority of XELOX vs FOLFOX-4 with respect to overall survival and no margin could be derived following the effect retention concept. The same margins used for the PFS analysis [Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin)] were therefore applied to OS as well.|Hazard Ratio (HR)|0.97|||||2-Sided|97.5|0.84|1.14||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).|
1766133|NCT00069095|3242159|Superiority or Other||Hazard Ratio (HR)|0.83||||0.0015|2-Sided|97.5|0.72|0.95|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone [HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)] was presented.|
1766134|NCT00069095|3242160|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.03|||||2-Sided|97.5|0.92|1.15||||||Equivalence of treatment arm A (‘XELOX’) to treatment arm B (‘FOLFOX-4’) was tested via the following hypotheses - H0: HRA/B >/= 1.23 versus H1: HRA/B < 1.23. HRA/B denotes the hazard of disease progression or death under treatment A (‘XELOX’) divided by the hazard of disease progression or death under treatment B (‘FOLFOX-4’).|
1766135|NCT00069095|3242161|Superiority or Other||Hazard Ratio (HR)|0.63|||<|0.0001|2-Sided|97.5|0.52|0.75|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone [HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)] was presented.|
1766136|NCT00069095|3242162|Non-Inferiority or Equivalence|Fewer events were expected in the ‘on-treatment analysis’, thus leading to reduced power. No formal statistical testing was therefore applied.|Hazard Ratio (HR)|1.24|||||2-Sided|97.5|1.07|1.44||||||HRs and 97.5% confidence interval were reported for treatment arm A (XELOX/XELOX+P/XELOX+BV) versus treatment arm B (FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV).|
1766137|NCT00069095|3242163|Superiority or Other||Hazard Ratio (HR)|0.7|||<|0.0001|2-Sided|97.5|0.58|0.83|||Log Rank|||Testing for superiority was based on the stratified log-rank test and used a two-sided significance level of 2.5%.The hazard ratio (HR) of bevacizumab in combination with chemotherapy versus chemotherapy alone [HR(FOLFOX-4+P/XELOX+P)/(FOLFOX-4+BV/XELOX+BV)] was presented.|
1766138|NCT00069095|3242164|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.22|||||2-Sided|97.5|1.05|1.42||||||Equivalence of treatment arm A (‘XELOX’) to treatment arm B (‘FOLFOX-4’) was tested via the following hypotheses - H0: HRA/B >/= 1.23 versus H1: HRA/B < 1.23. HRA/B denotes the hazard of disease progression or death under treatment A (‘XELOX’) divided by the hazard of disease progression or death under treatment B (‘FOLFOX-4’).|
1766139|NCT00069095|3242165|Non-Inferiority or Equivalence|Non-inferiority was demonstrated if the upper limit of the 2-sided 97.5% confidence interval (CI) for the hazard ratio (HR) was less than the predefined limit of 1.23 (the non-inferiority margin). A stratified Cox model was used. In order to retain an experiment-wise two-sided type I error of 5%, the non-inferiority analysis for PFS used a two-sided significance level of 2.5%.|Hazard Ratio (HR)|1.05|||||2-Sided|97.5|0.94|1.18||||||Equivalence of treatment arm A (‘XELOX’) to treatment arm B (‘FOLFOX-4’) was tested via the following hypotheses - H0: HRA/B >/= 1.23 versus H1: HRA/B < 1.23. HRA/B denotes the hazard of disease progression or death under treatment A (‘XELOX’) divided by the hazard of disease progression or death under treatment B (‘FOLFOX-4’).|
1766140|NCT00069160|3242169|Superiority or Other||||||>|0.05|||||||t-test, 2 sided||||
1766141|NCT00068822|3242172|Superiority or Other||Adjusted treatment effect|0.7||||0.19|2-Sided|95.0|-0.3|1.7|||ANCOVA|||Between group comparisons, confidence intervals, and P values were calculated with the use of analysis-of-covariance models with adjustment for study group assignment, baseline value of the outcome measure, and study center. Negative treatment effects favor the control procedure, and positive treatment effects favor vertebroplasty.|
1766142|NCT00068822|3242173|Superiority or Other||Treatment Effect|0.4||||0.5|2-Sided|95.0|-0.8|1.6|||ANCOVA|||SOF-ADL treatment effect|
1766143|NCT00068822|3242173|Superiority or Other||Treatment Effect|0.05||||0.13|2-Sided|95.0|-0.01|0.11|||ANCOVA|||EQ-5D Index treatment effect|
1766144|NCT00068822|3242173|Superiority or Other||Treatment Effect|0.33||||0.33|2-Sided|95.0|-0.2|0.6|||ANCOVA|||Pain Bothersome Index treatment effect|
1766145|NCT00068822|3242173|Superiority or Other||Treatment Effect|0.2||||0.33|2-Sided|95.0|-0.2|0.6|||ANCOVA|||Pain Frequency Index treatment effect|
1766146|NCT00068822|3242173|Superiority or Other||Treatment Effect|1.0||||0.83|2-Sided|95.0|-3.7|4.6|||ANCOVA|||SF-36 Mental Component Summary treatment effect|
1766147|NCT00068822|3242173|Superiority or Other||Treatment Effect|1.0||||0.45|2-Sided|95.0|-1.7|3.7|||ANCOVA|||SF-36 Physical Component Summary treatment effect|
1766148|NCT00068822|3242174|Superiority or Other||Adjusted treatment effect|0.7||||0.49|2-Sided|95.0|-1.3|2.8|||ANCOVA|||Between group comparisons, confidence intervals, and P values were calculated with the use of analysis-of-covariance models with adjustment for study group assignment, baseline value of the outcome measure, and study center. Negative treatment effects favor the control procedure, and positive treatment effects favor vertebroplasty.|
1766149|NCT00068770|3242175|Non-Inferiority or Equivalence|equivalence analysis|Hazard Ratio (HR)|2.7|Standard Deviation|1.8||0.11|2-Sided|95.0|1.1|6.3|||Log Rank||||
1766150|NCT00068770|3242176|Superiority or Other||Mean Difference (Final Values)|3.5|Standard Deviation|1.0||0.82|2-Sided|95.0|1.5|5.5||not adjusted|t-test, 2 sided|||two independent group comparisons|
1766151|NCT00068692|3242187|Superiority|||||||0.69||||||one-sided p value was reported|Log Rank|stratified on ECOG performance status, clinical stage, timing of chemoradiaotherapy, regimen administration|||
1766152|NCT00068692|3242187|Superiority|||||||0.35||||||One-sided p value was reported|Log Rank|stratified on ECOG performance status, clinical stage, timing of chemoradiotherapy, and regimen administration|||
1766153|NCT00068445|3242195|Superiority|||||||0.68|||||||Wilcoxon (Mann-Whitney)||||
1766154|NCT00068445|3242196|Superiority|||||||0.91|||||||Wilcoxon (Mann-Whitney)||||
1766155|NCT00068445|3242197|Superiority|||||||0.07|||||||Wilcoxon (Mann-Whitney)||||
1766156|NCT00068445|3242198|Superiority|||||||0.33|||||||Wilcoxon (Mann-Whitney)||||
1766157|NCT00068445|3242199|Superiority|||||||0.22|||||||Wilcoxon (Mann-Whitney)||||
1766158|NCT00068445|3242200|Superiority|||||||0.53|||||||Wilcoxon (Mann-Whitney)||||
1766159|NCT00068445|3242201|Superiority|||||||0.34|||||||Wilcoxon (Mann-Whitney)||||
1766160|NCT00068445|3242202|Superiority|||||||0.25|||||||Wilcoxon (Mann-Whitney)||||
1766161|NCT00068445|3242203|Superiority|||||||0.36|||||||Wilcoxon (Mann-Whitney)||||
1766162|NCT00068445|3242204|Superiority|||||||0.56|||||||Wilcoxon (Mann-Whitney)||||
1766163|NCT00068250|3242232|Other|||||||0.82|||||||Chi-squared|One-sample test of proportions||RTOG 93-10 reported a pre-irradiation chemotherapy complete response rate of 59%. A chi-square test with a 0.20 one-sided significance level provides 81% power to detect the difference between a null hypothesis complete response rate of 59% and the alternative rate of 71% (a 20% increase) for the planned sample size of 52 patients.|
1766164|NCT00068250|3242233|Superiority|||||||0.006|||||||One-sample z-test|||Null hypothesis: Two-year survival rate <= 64%; Alternative hypothesis: Two-year survival rate > 64%. The fixed survival rate for comparison comes from Radiation Therapy Oncology Group (RTOG) trial 9310. (RTOG 9310 does not fall within ClinicalTrials.gov registration/reporting requirements.)|
1766165|NCT00068250|3242234|Other||||||||||||||||||Dose escalation followed the standard 3+3 design, although up to six patients could be accrued per dose level before suspending accrual for toxicity evaluation. If none of the first three patients (0/3), or one of the first three and none of the second three (1/3 and 0/3), experience a DLT, then the current dose level would be considered acceptable, and the next dose opened. Otherwise, the current dose level would be considered too toxic. The highest dose achieved with an acceptable level of toxicity was to considered the Maximum Tolerable Dose (MTD). If at any time a grade 5 toxicity was observed, accrual will be suspended, and the Study Chair would review the event. Furthermore, if the cumulative incidence (obtained by time to event analysis), at any time, of combined acute/late DLTs estimated the toxicity rate to be greater than 30% at any dose level, then the Executive Committee will be notified, and the committee would determine whether to stop accrual.
1766166|NCT00068107|3242249|Superiority or Other||Average Delay in time to ESRD|166.0|||||2-Sided|95.0|8.4|323.8|||||The average delay in end stage renal disease (ESRD) calculated from the eGFR values and represents the estimated difference in time to ESRD between Relagal administered every 2 weeks and Relagal administered weekly. Units = months||
1766167|NCT00068107|3242249|Superiority or Other|||||||0.01|||||||t-test, 2 sided|||eGFR measured pre-study was compared to eGFR during the study|
1766168|NCT00067470|3242254|Superiority or Other||Mean Difference (Net)|5.7|Standard Error of the Mean|2.9||0.053||95.0|-0.1|11.5|||Regression, Linear|The raw data were adjusted for the observed differences in baseline between the groups and fitted to a longitudinal repeated measures linear model.|||
1766169|NCT00067470|3242255|Superiority or Other||Mean Difference (Net)|92.0|Standard Error of the Mean|40.0||0.025||95.0|11.0|172.0|||Regression, Linear||||
1766170|NCT00067236|3242256|Superiority or Other||Mean Difference (Net)|4.0||||0.4239|2-Sided|95.0|||||ANOVA|||Changes from baseline in efficacy parameters at Day 90.|
1766171|NCT00066963|3242262|Superiority or Other||Odds Ratio (OR)|3.8|||<|0.001|2-Sided|95.0|1.9|7.6|||Mantel Haenszel|2 d.f.|Counseling Only vs FV 2x/yr+Counseling|Planned sample size of 384 participants (128/study arm) (alpha = 0.05, power = 90%, 50% attrition, χ2 test) to detect caries incidence differences, based on caries incidence in the literature (20% to 50% over two years). 50% attrition in the sample size calculation was selected based on the literature (e.g. Weinstein et al., 1994 reported 53% attrition in six months.)|
1766172|NCT00066937|3242263|Other||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)|||
1766173|NCT00066937|3242264|Other||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)|||
1766174|NCT00066937|3242265|Other||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)|||
1766175|NCT00066937|3242266|Other||||||<|0.05|||||||ANOVA|Repeated measures ANOVAs compared baseline to each timepoint|||
1766176|NCT00066703|3242277|Superiority||Hazard Ratio (HR)|0.98||||0.84|2-Sided|95.0|0.79|1.22|||Log Rank||T+OFS was the reference group in the estimation of the hazard ratio||
1766177|NCT00066703|3242278|Superiority or Other (legacy)||Hazard Ratio (HR)|0.777||||0.02|2-Sided|95.0|0.624|0.967|||Log Rank||T+OFS was the reference group in the estimation of the hazard ratio||
1766178|NCT00066703|3242279|Superiority or Other (legacy)||Hazard Ratio (HR)|0.664|||<|0.0001|2-Sided|95.0|0.548|0.804|||Log Rank||T+OFS is the reference group for the estimation of the hazard ratio.||
1766179|NCT00066703|3242280|Superiority or Other (legacy)||Hazard Ratio (HR)|0.717||||0.0002|2-Sided|95.0|0.602|0.855|||Log Rank||T+OFS is the reference group in the estimation of the hazard ratio.||
1766180|NCT00066690|3242281|Superiority|[not specified]|Hazard Ratio (HR)|0.85|||||2-Sided|95.0|0.62|1.15|||||T was the reference group in the estimation of hazard ratio||
1766181|NCT00066690|3242281|Superiority|[not specified]|Hazard Ratio (HR)|0.67||||0.01|2-Sided|95.0|0.48|0.92|||Log Rank||T was the reference group in the estimation of the hazard ratio||
1766182|NCT00066690|3242282|Superiority||Hazard Ratio (HR)|0.71|||||2-Sided|95.0|0.52|0.96|||||T was the reference group in the estimation of hazard ratio.||
1766183|NCT00066690|3242282|Superiority||Hazard Ratio (HR)|0.88||||0.4|2-Sided|95.0|0.66|1.18|||Log Rank||T was the reference group in the estimation of the hazard ratio.||
1766184|NCT00066690|3242283|Superiority||Hazard Ratio (HR)|0.64|||||2-Sided|95.0|0.49|0.83|||||Tamoxifen was the reference group in the estimation of the hazard ratio.||
1766185|NCT00066690|3242283|Superiority||Hazard Ratio (HR)|0.81||||0.09|2-Sided|95.0|0.3|1.03|||Log Rank||Tamoxifen was the reference group in the estimation of the hazard ratio.||
1766186|NCT00066690|3242284|Superiority||Hazard Ratio (HR)|0.68|||||2-Sided|95.0|0.53|0.86|||||Tamoxifen was the reference group in the estimation of the hazard ratio.||
1766187|NCT00066690|3242284|Superiority||Hazard Ratio (HR)|0.83||||0.1|2-Sided|95.0|0.66|1.04|||Log Rank||Tamoxifen was the reference group in the estimation of the hazard ratio.||
1766188|NCT00066573|3242287|Superiority|No power calculation for secondary analysis|Hazard Ratio (HR)|0.93||||0.46|2-Sided|95.0|0.77|1.13|||Log Rank||||
1766189|NCT00066573|3242288|Superiority|To detect a hazard ratio (HR) of 0.80 between exemestane and anastrozole (ie, an improvement in 5-year EFS from 87.5% to 89.9%, with a two-sided 5% level test and 80% power, 6,840 patients and 630 events were needed for final analysis.|Hazard Ratio (HR)|1.02||||0.85|2-Sided|95.0|0.87|1.18|||Log Rank||||
1766190|NCT00066222|3242303|Other||||||||||||||||||The following rule would reject the null hypothesis that the proportion of treatment-related fatalities was less than or equal to 5% with an overall significance level of 0.05: 6 or more instances of treatment-related fatalities among the total sample of evaluable patients.
1766191|NCT00066222|3242304|Other||||||||||||||||||The following rule would reject the null hypothesis that the proportion of severe esophagitis was 30% with an overall significance level of 0.05: 27 or more cases of severe esophagitis among the total sample of evaluable patients.
1766192|NCT00066222|3242307|Other|||||||||||||||||This study was designed to detect an improvement in the 2-year overall survival rate from 47% to 60%. Using a one-group chi-square test with a one-sided significance level of 0.10, a sample of 67 patients was deemed sufficient to detect the difference between the null hypothesis (H0: P .47) and the alternative hypothesis (HA: P .60) with 80% power.|If the point estimate for two-year survival is less than or equal to 0.54815, the upper bound of the one-sided 90% confidence interval on 47%, then H0 would not be rejected and the conclusion would be that the two-year survival rate did not statistically improve from 47% under the new treatment. If the point estimate is greater than 0.54815, then H0 would be rejected and the conclusion is that the two-year survival rate did improve from 47% to 60% under the new treatment.
1766193|NCT00066170|3242308|Superiority or Other||||||<|0.001|||||||Dunnett's||||
1766194|NCT00066170|3242308|Superiority or Other||||||<|0.001|||||||Dunnett's||||
1766195|NCT00066066|3242309|Superiority or Other||||||>|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 12 months post-therapy.|
1766196|NCT00066066|3242309|Superiority or Other||||||<|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 6 months post-therapy.|
1766197|NCT00066066|3242309|Superiority or Other||||||<|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in smokers was tested by comparing change in mean CAL in individuals at 3 months post-therapy.|
1766198|NCT00066066|3242309|Superiority or Other||||||<|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 12 months post-therapy.|
1766199|NCT00066066|3242309|Superiority or Other||||||>|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 6 months post-therapy.|
1766200|NCT00066066|3242309|Superiority or Other||||||>|0.05||||||The p-value was not adjusted for multiple comparisons and the a priori threshold for significance was alpha = 0.05|ANOVA|||The null hypothesis of no difference among treatment groups in non-smokers was tested by comparing change in mean CAL in individuals at 3 months post-therapy.|
1766201|NCT00065611|3242332|Superiority or Other|||||||0.3792|||||||ANOVA||||
1766202|NCT00065611|3242333|Superiority or Other|||||||0.4566|||||||ANOVA||||
1766203|NCT00065611|3242334|Superiority or Other|||||||0.9074|||||||Chi-squared||||
1766204|NCT00065507|3242340|Superiority or Other||Hazard Ratio (HR)|0.74||||0.2|2-Sided|95.0|0.46|1.18|||Regression, Cox|Cox proportional hazard model, adjusted for age <=45 versus age >45 years, gender, and race (white versus non-white).||treatment comparison of HCC-free survival at Week 48|
1766205|NCT00065507|3242341|Superiority or Other||Difference Estimate|5.7|||||2-Sided|95.0|-0.3|11.7||||||Difference Estimate at Week 48|
1766206|NCT00065507|3242342|Superiority or Other||Difference Estimate|-7.2|||||2-Sided|95.0|-21.3|6.9||||||Difference Estimate at Week 48|
1766207|NCT00065507|3242343|Superiority or Other||Difference Estimate|-0.4|||||2-Sided|95.0|-8.7|8.0||||||Difference Estimate at Week 48|
1766208|NCT00065507|3242344|Superiority or Other||Difference Estimate|10.4|||||2-Sided|95.0|-4.5|25.2||||||Difference estimate ETV - ADV at Week 48|
1766209|NCT00065507|3242352|Superiority or Other||Mean Difference (Final Values)|0.59|||<|0.0001|2-Sided|95.0|-1.08|1.88|||Regression, Linear|Model estimate incorporates prognostic factors measured at baseline. Adjusted for baseline||Covariate adjusted model for MELD score at Week 48|
1766210|NCT00065507|3242352|Superiority or Other||Mean Difference (Final Values)|-0.41|||<|0.51|2-Sided|95.0|-1.63|0.82|||Regression, Linear|Model estimate incorporates prognostic factors measured at baseline. Adjusted for baseline||Covariate adjusted model for MELD score at Week 24|
1766211|NCT00065507|3242358|Superiority or Other||percent treatment difference|16.4||||0.0425|2-Sided|95.0|0.9|32.0|||Cochran-Mantel-Haenszel|||Week 48 treatment difference|
1766212|NCT00065507|3242358|Superiority or Other||percent treatment difference|19.2||||0.0193|2-Sided|95.0|3.7|34.6|||Cochran-Mantel-Haenszel|||Week 24 treatment difference|
1766213|NCT00065507|3242359|Superiority or Other||Mean percent treatment difference|38.0|||<|0.0001|2-Sided|95.0|24.8|50.3|||Cochran-Mantel-Haenszel||||
1766214|NCT00065507|3242360|Superiority or Other||Mean Percent Difference|32.7|||<|0.0001|2-Sided|95.0|20.2|45.2|||Cochran-Mantel-Haenszel||||
1766215|NCT00065507|3242361|Superiority or Other||Mean Difference (Final Values)|-1.4|||<|0.0001|2-Sided|95.0|-1.85|-0.96|||Regression, Linear|adjusted for baseline HBV DNA and LVDr Status|||
1766216|NCT00065507|3242362|Superiority or Other||Mean Difference (Final Values)|-1.74|||<|0.0001|2-Sided|95.0|-2.3|-1.18|||Regression, Linear|Linear regression model adjusted for baseline HBV DNA and LVDr status.|||
1766217|NCT00065468|3242365|Superiority or Other||Cox Proportional Hazard|0.73||||0.002|2-Sided|95.0|0.6|0.89|||Log Rank|Stratified by prior nephrectomy and region|||
1766218|NCT00065468|3242365|Superiority or Other||Cox Proportional Hazard|0.62|||<|0.0001|2-Sided|95.0|0.51|0.76|||Log Rank|Stratified by prior nephrectomy and region|||
1766219|NCT00065468|3242367|Superiority or Other|||||||0.0011|||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region|||
1766220|NCT00065468|3242367|Superiority or Other||||||<|0.0001|||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region|||
1766221|NCT00065468|3242368|Superiority or Other|||||||0.1062|||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region|||
1766222|NCT00065468|3242368|Superiority or Other|||||||0.1361|||||||Cochran-Mantel-Haenszel|Stratified by prior nephrectomy and region|||
1766223|NCT00065468|3242369|Superiority or Other||Cox Proportional Hazard|0.76||||0.0107|2-Sided|95.0|0.62|0.94|||Log Rank|Stratified by prior nephrectomy and region|||
1766224|NCT00065468|3242369|Superiority or Other||Cox Proportional Hazard|0.74||||0.0042|2-Sided|95.0|0.6|0.91|||Log Rank|Stratified by prior nephrectomy and region|||
1766225|NCT00065468|3242370|Non-Inferiority or Equivalence|2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and IFN-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.|Cox Proportional Hazard|0.93||||0.4902|2-Sided|95.0|0.75|1.15|||Log Rank|Stratified by prior nephrectomy and region|||
1766226|NCT00065468|3242370|Non-Inferiority or Equivalence|2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and Interferon Alfa (IFN)-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.|Cox Proportional Hazard|0.78||||0.0252|2-Sided|95.0|0.63|0.97|||Log Rank|Stratified by prior nephrectomy and region|||
1766227|NCT00065442|3242371|Superiority or Other||Hazard Ratio (HR)|0.951||||0.628|2-Sided|95.0|0.773|1.169|||Log Rank|Stratified by randomization strata|Cox regression model with treatment as the independent variable, stratified by randomization strata||
1766228|NCT00065442|3242372|Superiority or Other||Hazard Ratio (HR)|0.766||||0.023|2-Sided|95.0|0.608|0.965|||Log Rank|Stratified by randomization strata.|Cox regression model with treatment as the independent variable, stratified by randomization strata (sipuleucel-T/placebo)||
1766229|NCT00065442|3242372|Superiority or Other||Hazard Ratio (HR)|0.775||||0.032|2-Sided|95.0|0.614|0.979|||Regression, Cox|Cox regression model with treatment, PSA (ln), and LDH (ln) as the independent variables, stratified by randomization strata.|sipuleucel-T/placebo||
1766230|NCT00065182|3242387|Superiority||Hazard Ratio (HR)|0.977|||||2-Sided|95.0|0.788|1.21|||||Adjusted hazard ratio.||
1766231|NCT00065182|3242387|Superiority||Hazard Ratio (HR)|1.007||||0.946|2-Sided|95.0|0.813|1.248|||Log Rank||Unadjusted hazard ratio.||
1766232|NCT00065065|3242402|Superiority or Other||Odds Ratio (OR)|4.0||||0.005||95.0|1.5|10.5|||Regression, Logistic||||
1766233|NCT00003895|3242403|Superiority or Other|||||||0.59||||||Arm A Versus Arm B|t-test, 2 sided||||
1766234|NCT00003895|3242403|Superiority or Other||||||<|0.0001||||||Post versus Pre-Treatment %g209-2M-specific T-cells|t-test, 2 sided||||
1766235|NCT00003895|3242403|Superiority or Other||||||<|0.001||||||Post versus Pre-treatment % g209-2M-specific t-cells|t-test, 2 sided||||
1766236|NCT00064844|3242411|Superiority or Other||chi square|7.25|||<|0.01||95.0|||||Chi-squared|df = 1, N = 96|||
1766237|NCT00064753|3242413|Superiority or Other||Cox Proportional Hazard|1.3||||0.6|2-Sided|95.0|0.48|3.5|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country|||
1766238|NCT00064753|3242414|Superiority or Other||Cox Proportional Hazard|0.61||||0.5|2-Sided|95.0|0.15|2.57|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country|||
1766239|NCT00064753|3242415|Superiority or Other||Cox Proportional Hazard|1.14||||0.78|2-Sided|95.0|0.46|2.8|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country|||
1766240|NCT00064753|3242416|Superiority or Other||Cox Proportional Hazard|1.14||||0.49|2-Sided|95.0|0.79|1.65|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country|||
1766241|NCT00064753|3242417|Superiority or Other||Cox Proportional Hazard|0.95||||0.7|2-Sided|95.0|0.73|1.23|||Regression, Cox|P was calculated with stratified proportional hazards models stratified by country|||
1766242|NCT00064753|3242418|Superiority or Other||Cox Proportional Hazard|0.84||||0.28|2-Sided|95.0|0.62|1.15|||Regression, Cox||||
1766243|NCT00064753|3242419|Superiority or Other||Cox Proportional Hazard|0.8||||0.66|2-Sided|95.0|0.3|2.15||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox||||
1766244|NCT00064753|3242420|Superiority or Other||Cox Proportional Hazard|1.12||||0.64|2-Sided|95.0|0.69|1.81||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox||||
1766245|NCT00064753|3242421|Superiority or Other||Cox Proportional Hazard|1.08||||0.61|2-Sided|95.0|0.8|1.45||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox||||
1766246|NCT00064753|3242422|Superiority or Other||Cox Proportional Hazard|1.04||||0.67|2-Sided|95.0|0.86|1.26||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox||||
1766247|NCT00064753|3242423|Superiority or Other||Cox Proportional Hazard|1.15||||0.19|2-Sided|95.0|0.93|1.43||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox||||
1766248|NCT00064753|3242424|Superiority or Other||Cox Proportional Hazard|0.99||||0.93|2-Sided|95.0|0.84|1.17||P was calculated with stratified proportional hazards models stratified by country|Regression, Cox||||
1766249|NCT00064792|3242429|Superiority or Other|||||||0.22|||||||t-test, 2 sided||||
1766250|NCT00064792|3242430|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||The primary outcome variable will be the serum cholesterol/total sterol ratio.|
1766251|NCT00064701|3242431|Superiority or Other||Mean Difference (Final Values)|0.8|||||2-Sided|95.0|-7.1|8.6|||||||
1766252|NCT00064701|3242431|Superiority or Other||Mean Difference (Final Values)|-1.3|||||2-Sided|95.0|-9.1|6.6|||||||
1766253|NCT00064701|3242432|Superiority or Other||Mean Difference (Final Values)|1.5|||||2-Sided|95.0|-3.9|6.9|||||||
1766254|NCT00064701|3242432|Superiority or Other||Mean Difference (Final Values)|-0.5|||||2-Sided|95.0|-6.5|5.5|||||||
1766255|NCT00064701|3242442|Non-Inferiority or Equivalence|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 12 months|-3.4|||||2-Sided|95.0|-9.6|2.8||||||Comparison of Tacrolimus Modified Release with Cyclosporine at 12 months|
1766256|NCT00064701|3242442|Non-Inferiority or Equivalence|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 12 Months|-6.1|||||2-Sided|95.0|-12.0|-0.3||||||Comparison of tacrolimus with cyclosporine at 12 months|
1766257|NCT00064701|3242442|Non-Inferiority or Equivalence|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 6 Months|-3.8|||||2-Sided|95.0|-9.5|1.8||||||Comparison of Tacrolimus Modified Release with Cyclosporine at 6 months|
1766258|NCT00064701|3242442|Non-Inferiority or Equivalence|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference at 6 Months|-8.0|||||2-Sided|95.0|-13.1|-3.0||||||Comparison of tacrolimus with cyclosporine at 6 months|
1766259|NCT00064701|3242443|Non-Inferiority or Equivalence|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|0.0|||||2-Sided|95.0|-4.0|4.1|||||||
1766260|NCT00064701|3242443|Non-Inferiority or Equivalence|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.8|||||2-Sided|95.0|-8.5|0.9|||||||
1766261|NCT00064701|3242444|Non-Inferiority or Equivalence|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|0.0|||||2-Sided|95.0|-3.1|3.2|||||||
1766262|NCT00064701|3242444|Non-Inferiority or Equivalence|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.3|||||2-Sided|95.0|-7.2|0.6|||||||
1766263|NCT00064701|3242445|Non-Inferiority or Equivalence|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-3.0|||||2-Sided|95.2|-9.9|4.0|||||||
1766264|NCT00064701|3242445|Non-Inferiority or Equivalence|The non-inferiority margin for this study was pre-specified as 10%.|Incidence Difference|-1.9|||||2-Sided|95.2|-8.9|5.2|||||||
1766265|NCT00064662|3242446|Superiority or Other||Other|0.0|||<|0.0001||95.0|||||Kalpan Meier (Wald statistic)|||Kaplan Meier time-to-event analysis of cumulative success rates. Used Wald test of equality of survival distributions.|
1766266|NCT00064662|3242446|Superiority or Other||Chi-square|16.2|||<|0.001||95.0|||||Log Rank|||Time to event analysis of cumulative success rates in the two groups. Null hypothesis is that the distributions are equal in the two groups.|
1766267|NCT00064662|3242447|Superiority or Other||Other|0.0||||0.01||95.0|||||Log Rank|||Time to event analysis of 24 month success rates. Null hypothesis is that the distributions in the two groups are equal.|
1766268|NCT00064350|3242449|Superiority or Other|||||||0.12|||||||Log Rank|||Compare OS between the Sorafenib arm and the placebo arm|
1766269|NCT00064350|3242450|Superiority or Other|||||||0.014|||||||Log Rank|||Compare PFS between the Sorafenib arm and the placebo arm|
1766270|NCT00064350|3242451|Superiority or Other|||||||0.005|||||||Fisher Exact|||Compare the proportion of patients maintaining stable disease or objective response at 2 months after randomization between the two arms.|
1766271|NCT00064025|3242466|Superiority or Other||||||<|0.001|||||||Paired t-test||||
1766272|NCT00064025|3242467|Superiority or Other||||||<|0.001|||||||Paired t-test||||
1766273|NCT00064025|3242468|Superiority or Other|||||||0.701|||||||Fisher Exact||||
1766306|NCT00063635|3242505|Superiority or Other|||||||0.02|||||||Chi-squared||||
1766307|NCT00063635|3242506|Superiority or Other|||||||0.73|||||||Chi-squared||||
1766274|NCT00063882|3242490|Superiority||Effect size|0.27||||0.0072|2-Sided|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7.|Sexual|
1766275|NCT00063882|3242490|Superiority||Effect size|0.42|||<|0.0001|2-Sided|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7.|Bowel|
1766276|NCT00063882|3242490|Superiority||Effect size|0.44|||<|0.0001|2-Sided|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7.|Urinary-Irritative|
1766277|NCT00063882|3242490|Superiority||Effect size|0.08|||<|0.42|2-Sided|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7.|Urinary-Incontinence|
1766278|NCT00063882|3242490|Superiority||Effect size|0.38|||<|0.0002|2-Sided|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7.|Urinary|
1766279|NCT00063882|3242491|Superiority||Effect size|0.12||||0.23|2-Sided||||||t-test, 2 sided|||Sexual|Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7.
1766280|NCT00063882|3242491|Superiority||Effect size|0.31||||0.001|2-Sided|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7.|Bowel|
1766281|NCT00063882|3242491|Superiority||Effect size|0.44|||<|0.0001|2-Sided|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7.|Urinary-Irritative|
1766282|NCT00063882|3242491|Superiority||Effect size|0.09|||<|0.33|2-Sided|||||significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7.|Urinary- Incontinence|
1766283|NCT00063882|3242491|Superiority||Effect size|0.4|||<|0.0001|2-Sided|||||Significance level of 0.01|t-test, 2 sided||Minimally important difference (MID) defined as an effect size of at least 0.5. Effect sizes are interpreted as negligible: < 0.3; small: 0.3 to < 0.5; moderate: 0.5 to < 0.7; and large ≥ 0.7.|Urinary|
1766284|NCT00063882|3242492|Superiority||Hazard Ratio (HR)|1.81||||0.029|2-Sided|95.0|1.06|3.1||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|Grade 3+ Overall|
1766285|NCT00063882|3242492|Superiority||Hazard Ratio (HR)|2.37||||0.01|2-Sided|95.0|1.2|4.68||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only|Grade 3+ GU/GI|
1766286|NCT00063882|3242493|Superiority||Odds Ratio (OR)|0.93||||0.82|2-Sided|95.0|0.51|1.69||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 3+ Overall|
1766287|NCT00063882|3242493|Superiority||Odds Ratio (OR)|1.09||||0.81|2-Sided|95.0|0.54|2.19||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 3+ GU/GI|
1766288|NCT00063882|3242493|Superiority||Odds Ratio (OR)|1.06||||0.73|2-Sided|95.0|0.73|1.53||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 2+ Overall|
1766289|NCT00063882|3242493|Superiority||Odds Ratio (OR)|1.13||||0.53|2-Sided|95.0|0.76|1.67||One-sided significance level of 0.05|Chi-squared||Reference level = Brachytherapy Only|Grade 2+ GU/GI|
1766290|NCT00063882|3242494|Superiority||Hazard Ratio (HR)|0.77||||0.22|2-Sided|95.0|0.51|1.17||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only||
1766291|NCT00063882|3242495|Superiority||Hazard Ratio (HR)|1.12||||0.81|2-Sided|95.0|0.46|2.76||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only||
1766292|NCT00063882|3242496|Superiority||Hazard Ratio (HR)|1.01||||0.99|2-Sided|95.0|0.33|3.13||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only||
1766293|NCT00063882|3242497|Superiority||Hazard Ratio (HR)|1.19||||0.77|2-Sided|95.0|0.36|3.9||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only||
1766294|NCT00063882|3242498|Superiority||Hazard Ratio (HR)|1.0||||0.97|2-Sided|95.0|0.64|1.58||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only||
1766295|NCT00063882|3242499|Superiority||Hazard Ratio (HR)|0.99||||0.95|2-Sided|95.0|0.63|1.54||One-sided significance level of 0.025|Log Rank||Reference level = Brachytherapy Only||
1766296|NCT00063882|3242500|Superiority||Cox Proportional Hazard|0.82||||0.21|2-Sided|95.0|0.6|1.12||One-sided significance level of 0.025|Greenwood's T||Reference level = Brachytherapy only|Target sample size was 586; 532 patients were needed to test hypothesis of better FFP in the EBRT + Brachytherapy arm over the Brachytherapy Only arm. The trial is designed to detect a 10% improvement in 5-year FFP with 90% power, 1-sided alpha of 0.025. The Z-test statistic for the difference between the 2 5-year FFP rates with the standard errors estimated by Greenwood’s method will be used.|
1766297|NCT00063635|3242501|Superiority or Other|||||||0.96|||||||ANCOVA||||
1766298|NCT00063635|3242501|Superiority or Other|||||||0.15|||||||ANCOVA||||
1766299|NCT00063635|3242502|Superiority or Other|||||||0.63|||||||ANCOVA||||
1766300|NCT00063635|3242502|Superiority or Other|||||||0.08|||||||ANCOVA||||
1766301|NCT00063635|3242503|Superiority or Other|||||||0.44|||||||ANCOVA||||
1766302|NCT00063635|3242503|Superiority or Other||||||<|0.001|||||||ANCOVA||||
1766303|NCT00063635|3242504|Superiority or Other|||||||0.25|||||||ANCOVA||||
1766304|NCT00063635|3242504|Superiority or Other|||||||0.77|||||||ANCOVA||||
1766305|NCT00063635|3242505|Superiority or Other|||||||0.02|||||||Chi-squared||||
1766308|NCT00063635|3242506|Superiority or Other|||||||0.89|||||||Chi-squared||||
1766309|NCT00063635|3242507|Superiority or Other|||||||0.25|||||||Chi-squared||||
1766310|NCT00063635|3242507|Superiority or Other|||||||0.18|||||||Chi-squared||||
1766311|NCT00063635|3242508|Superiority or Other|||||||0.72|||||||Chi-squared||||
1766312|NCT00063635|3242508|Superiority or Other|||||||0.71|||||||Chi-squared||||
1766313|NCT00063635|3242509|Superiority or Other|||||||0.25|||||||ANCOVA||||
1766314|NCT00063635|3242509|Superiority or Other|||||||0.02|||||||ANCOVA||||
1766315|NCT00063635|3242510|Superiority or Other|||||||0.29|||||||ANCOVA||||
1766316|NCT00063635|3242510|Superiority or Other|||||||0.32|||||||ANCOVA||||
1766317|NCT00063635|3242511|Superiority or Other|||||||0.83||||||Since two primary comparisons are planned, a P-value of 0.025 will be considered significant, applying a Bonferroni correction for multiple comparisons.|Mantel Haenszel||||
1766318|NCT00063635|3242511|Superiority or Other|||||||0.26||||||Since two primary comparisons are planned, a P-value of 0.025 will be considered significant, applying a Bonferroni correction for multiple comparisons.|Mantel Haenszel||||
1766319|NCT00063622|3242512|Superiority or Other|||||||0.001|||||||Fisher Exact||||
1766320|NCT00063622|3242512|Superiority or Other|||||||0.05|||||||Fisher Exact||||
1766321|NCT00063622|3242513|Superiority or Other|||||||0.12|||||||Fisher Exact||||
1766322|NCT00063622|3242513|Superiority or Other|||||||0.24|||||||Fisher Exact||||
1766323|NCT00063622|3242514|Superiority or Other|||||||0.08|||||||Fisher Exact||||
1766324|NCT00063622|3242514|Superiority or Other|||||||0.01|||||||Fisher Exact||||
1766325|NCT00063622|3242515|Superiority or Other|||||||0.004|||||||Fisher Exact||||
1766326|NCT00063622|3242515|Superiority or Other|||||||0.02|||||||Fisher Exact||||
1766327|NCT00063622|3242516|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1766328|NCT00063622|3242516|Superiority or Other||||||<|0.005|||||||Fisher Exact||||
1766329|NCT00063622|3242517|Superiority or Other|||||||0.04||||||Given the fact that there were two planned primary comparisons, Bonferroni-adjusted P values of less than 0.025 were considered to indicate statistical significance.|Mantel Haenszel|||The proportions in each active-treatment group (pioglitazone and vitamin E) in whom there was improvement in non-alcoholic steatohepatitis were compared with the proportion of subjects in the placebo group in whom there was improvement.|
1766330|NCT00063622|3242517|Superiority or Other|||||||0.001||||||Given the fact that there were two planned primary comparisons, Bonferroni-adjusted P values of less than 0.025 were considered to indicate statistical significance.|Mantel Haenszel|||The proportions in each active-treatment group (pioglitazone and vitamin E) in whom there was improvement in non-alcoholic steatohepatitis were compared with the proportion of subjects in the placebo group in whom there was improvement.|
1766331|NCT00063232|3242529|Superiority or Other|||||||0.04|||||||paired t-test||||
1766332|NCT00063232|3242530|Superiority or Other|||||||0.04|||||||Fisher Exact|||self-controlled comparison of serum aminotransferase levels at 48 weeks and baseline. Null hypothesis: No change|
1766333|NCT00063232|3242531|Superiority or Other||||||<|0.001|||||||paired t-test|||"self-controlled comparison of NASH activity index at 48 weeks and baseline. Null hypothesis is no change."|
1766334|NCT00062764|3242535|Superiority or Other|||||||0.004|||||||paired t-test||||
1766335|NCT00062738|3242552|Superiority or Other||Odds Ratio (OR)|3.7|||<|0.05|2-Sided|95.0|0.8|15.9|||Fisher Exact|||For the responder analysis, an LOCF approach was used in which a clinical response was operationally defined as at least a 50% reduction in the HAM-D score from baseline to 8 weeks. Clinical response was cross-tabulated with treatment and Fisher exact test was used to distinguish differences among these groups.|
1766336|NCT00062647|3242554|Non-Inferiority or Equivalence|No margin was justified owing to the exploratory nature of the investigation.|Risk Difference (RD)|1.0||||||95.0|-35.5|31.9|||||||
1766337|NCT00062166|3242565|Non-Inferiority|Time dependent risk for requiring an intervention for pancreatic neuroendocrine tumors (PNET), among 63 patients with PNETs with diameter >1.2 and <3 cm, and a known position of germline VHL pathogenic variant (n=63). Comparison between exon 3 vs exon 1 and 2.|Hazard Ratio (HR)|3.3||||0.02|2-Sided|95.0|1.2|9.1|||Regression, Cox||||
1766338|NCT00062010|3242569|Superiority or Other||Overall Response Percentage|8.8|||||2-Sided|90.0|2.4|21.3||||||The study was designed to have adequate (90%) power to distinguish a true response rate of 50% from a null rate of 35% assuming total accrual of 76 patients in two stages. The design mandated that at least 13 objective responses be observed among 34 patients in the first stage in order to continue to the second stage. These were not observed, so the study stopped after the first stage. 90% exact binomial confidence intervals are provided for the response rate.|
1766339|NCT00061633|3242580|Non-Inferiority or Equivalence|Sample size was selected on the basis of clinical judgment and was deemed adequate to provide clinically meaningful descriptive results consistent with study objectives. This sample size was estimated to provide 39% power to test televancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 10%.||||||0.5289|||||||2-sided 95% confidence interval|||95% Confidence Interval: -0.1349 to 0.0485 No est. value. Parameter that was estimated: Risk Difference|
1766340|NCT00060944|3242592|Superiority or Other||Hazard Ratio (HR)|0.843||||0.192|2-Sided|95.0|0.653|1.09|||Log Rank||||
1766341|NCT00060944|3242593|Superiority or Other||Hazard Ratio (HR)|0.755||||0.0418|2-Sided|95.0|0.574|0.992|||Log Rank||||
1766342|NCT00060944|3242596|Superiority or Other||Hazard Ratio (HR)|0.734||||0.0302|2-Sided|95.0|0.554|0.974|||Log Rank||||
1766343|NCT00060008|3242615|Superiority or Other|||||||0.016|||||||Wilcoxon (Mann-Whitney)||||
1766344|NCT00059332|3242625|Superiority or Other||Odds Ratio (OR)|0.99||||0.95|2-Sided|95.0|0.76|1.29|||Chi-squared||||
1766345|NCT00059332|3242626|Superiority or Other||Odds Ratio (OR)|0.62||||0.12|2-Sided|95.0|0.34|1.14|||Chi-squared||||
1766346|NCT00059332|3242627|Superiority or Other||Odds Ratio (OR)|1.05||||0.95|2-Sided|95.0|0.87|1.27|||Chi-squared||||
1766347|NCT00059332|3242628|Superiority or Other|||||||0.323|||||||Wilcoxon (Mann-Whitney)||||
1766348|NCT00059332|3242629|Superiority or Other|||||||0.3912|||||||Wilcoxon (Mann-Whitney)||||
1766349|NCT00059332|3242630|Superiority or Other|||||||0.276|||||||Wilcoxon (Mann-Whitney)||||
1766350|NCT00059332|3242631|Superiority or Other||Odds Ratio (OR)|0.98||||0.87|2-Sided|95.0|0.81|1.19|||Chi-squared||||
1766351|NCT00059332|3242632|Superiority or Other||Odds Ratio (OR)|0.98||||0.87|2-Sided|95.0|0.81|1.2|||Chi-squared||||
1766352|NCT00059332|3242633|Superiority or Other|||||||0.28|||||||Cochran-Mantel-Haenszel|||For the primary efficacy analysis, data were analyzed to test the null hypothesis that the distribution of scores over all 7 levels of the modified Rankin Scale at Day 90 was identical in the magnesium sulfate and placebo groups, vs. the one-sided alternative that the distribution of scores is shifted lower in the active magnesium sulfate therapy group. The statistic used to test the primary hypothesis was the Cochran-Mantel-Haenszel test statistic stratified by transport vehicle.|
1766353|NCT00059215|3242634|Superiority or Other|||||||0.37|||||||Fisher Exact||||
1766354|NCT00059215|3242635|Superiority or Other|||||||0.544|||||||Log Rank||||
1766355|NCT00059215|3242635|Superiority or Other|||||||1|||||||Fisher Exact||||
1766356|NCT00059215|3242636|Superiority or Other|||||||0.26|||||||Log Rank||||
1766357|NCT00059215|3242636|Superiority or Other|||||||0.945|||||||Fisher Exact||||
1766358|NCT00059215|3242637|Superiority or Other|||||||0.59|||||||Log Rank||||
1766359|NCT00059215|3242637|Superiority or Other|||||||0.933|||||||Fisher Exact||||
1766360|NCT00058058|3242675|Other||ROC analysis|0.9355|||||2-Sided|95.0|0.8956|0.9753|||||exact CI|ROC analysis - estimates the accuracy of MRI within 90 days of a negative mammogram to detect cancer in the contralateral breast|
1766361|NCT00058058|3242676|Other||Binomial Proportion|0.031|Standard Error of the Mean|0.00556|||2-Sided|95.0|0.021|0.044||||||B. Diagnostic Yield for ALL Cases in Analysis Set Diagnostic Yield - estimates the likelihood that the MRI within 90 days of a negative mammogram will provide the information needed to establish a diagnosis|
1766362|NCT00058058|3242676|Other||Binomial Proportion|0.9964|Standard Error of the Mean|0.0021|||2-Sided|95.0|0.9894|0.9993||||||"B. NPV Analysis for ALL Cases in Analysis Set NPV estimate - estimates the P(D-|T-), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"|
1766363|NCT00058058|3242676|Other||Binomial Proportion|0.2083|Standard Error of the Mean|0.0338|||2-Sided|95.0|0.1452|0.2839||||||"PPV estimate - estimates the P(D+|T+), where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)."|
1766364|NCT00058058|3242676|Other||Binomial Proportion|0.8782|Standard Error of the Mean|0.0107|||2-Sided|95.0|0.8555|0.8985||||||"Specificity - estimates the P(T-|D-) of MRI where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"|
1766365|NCT00058058|3242676|Other||Binomial Proportion|0.9091|Standard Error of the Mean|0.05004|||2-Sided|95.0|0.7567|0.9809||||||"Sensitivity estimate - estimates the P(T+|D+) where the MRI within 90 days of a negative mammogram is the test (T) and cancer in the contralateral breast is the Disease status(D)"|
1766366|NCT00058058|3242677|Other||Binomial Proportion|0.032|Standard Error of the Mean|0.006|||2-Sided|95.0|0.021|0.043||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 based on initial MRI and subsequent work-up|
1766367|NCT00058058|3242677|Other||Binomial Proportion|0.032|Standard Error of the Mean|0.006|||2-Sided|95.0|0.021|0.043||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 3, 4 or 5 on the initial MRI scan|
1766368|NCT00058058|3242677|Other||Binomial proportion|0.031|Standard Error of the Mean|0.006|||2-Sided|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 on the initial MRI scan|
1766369|NCT00058058|3242677|Other||Binomial Proportion|0.031|Standard Error of the Mean|0.006|||2-Sided|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up and a completed biopsy procedure|
1766370|NCT00058058|3242677|Other||Binomial Proportion|0.031|Standard Error of the Mean|0.006|||2-Sided|95.0|0.021|0.044||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 4 or 5 based on initial MRI and subsequent work-up|
1766371|NCT00058058|3242677|Other|Estimation of diagnostic yield|Binomial proportion|0.031|Standard Error of the Mean|0.006|||2-Sided|95.0|0.02|0.042||||||Diagnostic Yield is defined as the likelihood that a test or procedure will provide the information needed to establish a diagnosis. For this analysis, a Positive Test is defined as a score of BI-RADS 0, 4 or 5 based on Final BI-RADS|
1766372|NCT00058019|3242678|Superiority or Other|||||||0.55|||||||Log Rank||||
1766373|NCT00058019|3242679|Superiority or Other|||||||0.695|||||||Log Rank||||
1766374|NCT00058019|3242681|Superiority or Other|||||||1|||||||Fisher Exact||||
1766375|NCT00058019|3242682|Superiority or Other|||||||0.022|||||||Fisher Exact||||
1766376|NCT00057876|3242687|Superiority or Other|||||||0.99|||||||Fisher Exact|||Compare objective response rate (CR+PR) between two treatment groups|
1766377|NCT00057876|3242688|Superiority or Other|||||||0.25|||||||Log Rank||||
1766378|NCT00057876|3242689|Superiority or Other|||||||0.017|||||||Log Rank|||Log rank test is conducted for OS to see whether the two treatment arms are different in their overall survival probabilities.|
1766379|NCT00023673|3242709|Superiority|||||||0.08|||||||t-test, 2 sided|2-sided significance level = 0.05||Esophagitis toxicity (<Grade 2 vs. >= Grade 2): Mean Esophageal Dose|
1766380|NCT00023673|3242709|Superiority|||||||0.17|||||||t-test, 2 sided|2-sided significance level = 0.05||Esophagitis toxicity (<Grade 2 vs. >= Grade 2): Mean Lung Dose|
1766381|NCT00023673|3242709|Superiority|||||||0.3|||||||t-test, 2 sided|2-sided significance level = 0.05||Lung toxicity (<Grade 3 vs. >= Grade 3): Mean Lung Dose|
1766382|NCT00023673|3242710|Superiority|||||||0.22|||||||Wilcoxon (Mann-Whitney)|2-sided significance level = 0.05||Esophagitis toxicity (<Grade 2 vs. >= Grade 2): Lung V20|
1766383|NCT00023673|3242710|Superiority|||||||0.62|||||||Wilcoxon (Mann-Whitney)|2-sided significance level = 0.05||Lung toxicity (<Grade 3 vs. >= Grade 3): Lung V20|
1766384|NCT00057577|3242719|Superiority or Other||||||<|0.01|||||||Subdistribution hazard model||||
1766385|NCT00057577|3242720|Superiority or Other||||||=|0|||||||Subdistribution hazard model||||
1766386|NCT00056862|3242734|Superiority or Other|||||||0.047|||||||Log Rank|||Null hypothesis: the time to negativity for the two groups are same|
1766387|NCT00056862|3242735|Superiority or Other|||||||0.2|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: the second phase slopes of HCV RNA are the same for the two groups|
1766388|NCT00056862|3242737|Superiority or Other|||||||0.002|||||||t-test, 2 sided|||Null hypothesis: first phase decline in HCV RNA are the same for the two groups|
1766389|NCT00056472|3242746|Superiority or Other||||||<|0.001||||||The p-value is for the overall mean across all time points between each treatment group.|Mixed Models Analysis|||Intent-to-treat between group comparison using longitudinal mixed effects regression.|
1766390|NCT00056472|3242747|Superiority or Other|||||||0.02||||||The p-value is for the overall mean CGI-S score compared to baseline.|Mixed Models Analysis|This was a longitudinal analysis of CGI-S scores compared to baseline.||Intent-to-treat changes in global improvement from week to week compared to baseline (CGI-S) over the course of the trial using longitudinal mixed effects linear regression models. The null hypothesis is that there is no difference in overall change in CGI-S.|
1766391|NCT00056472|3242748|Superiority or Other||Odds Ratio (OR)|1.28|||<|0.001||95.0|1.12|1.47|||Regression, Logistic|||Predicting remission rates of 40% in combination therapy and 20% in monotherapy subjects, 260 subjects randomized into the two treatment groups would provide >80% power at a two-tailed alpha level of .05. Treatment efficacy was compared between groups based on intent-to-treat analyses for the longitudinal binary outcome of remission using mixed effects logistic regression with a random intercept that included treatment and time as fixed effects and a treatment by time interaction effect.|
1766392|NCT00056407|3242749|Superiority or Other||Difference in adjusted means|18.8|||<|0.001||95.0|17.3|20.4|||general linear model, t-test||The adjusted mean difference was calculated as the difference between the adjusted means (-6.1 and 12.7) for the placebo and Dutasteride arms, respectively.||
1766393|NCT00056407|3242772|Superiority or Other||Relative Risk Reduction|22.8|||<|0.0001||95.0|15.2|29.8||The p value is given for the overall assessment.|Mantel-Cox||Estimation data are given for the overall assessment.||
1766394|NCT00056407|3242773|Superiority or Other||Relative Risk Reduction|23.1|||<|0.0001||95.0|15.5|30.0||The p value is given is for the overall assessment.|Mantel-Cox||Estimation data are given are for the overall assessment.||
1766395|NCT00056407|3242774|Superiority or Other||Relative Risk Reduction|23.3|||<|0.0001||95.0|15.6|30.3||The p value is given is for the overall assessment.|Mantel-Cox||Estimation data given are for the overall assessment.||
1766396|NCT00056316|3242775|Superiority or Other||Mean Difference (Final Values)|2.07||||0.05||95.0|||||t-test, 2 sided||Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control||
1766397|NCT00056316|3242776|Superiority or Other||Mean Difference (Final Values)|1.93||||0.05||95.0|||||t-test, 2 sided||Mean difference is equal to Behavioral Skills Intervention minus Basic Education Control||
1766398|NCT00055497|3242796|Superiority or Other|||||||0.001|||||||Fisher Exact||||
1766399|NCT00055497|3242797|Superiority or Other|||||||0.004|||||||Fisher Exact|||Week 56|
1766400|NCT00055497|3242797|Superiority or Other|||||||0.508|||||||Fisher Exact|||Week 56|
1766401|NCT00055497|3242797|Superiority or Other|||||||0.003|||||||Fisher Exact|||Week 24|
1766402|NCT00055497|3242797|Superiority or Other|||||||0.191|||||||Fisher Exact|||Week 24|
1766403|NCT00055497|3242798|Superiority or Other|||||||0.044|||||||Fisher Exact|||Week 56|
1766404|NCT00055497|3242798|Superiority or Other|||||||0.508|||||||Fisher Exact|||Week 56|
1766405|NCT00055497|3242798|Superiority or Other|||||||0.001|||||||Fisher Exact|||Week 24|
1766406|NCT00055497|3242798|Superiority or Other|||||||0.33|||||||Fisher Exact|||Week 24|
1766407|NCT00055497|3242799|Superiority or Other|||||||0.029|||||||Fisher Exact||||
1766408|NCT00055497|3242800|Superiority or Other|||||||0.142|||||||Log Rank||||
1766409|NCT00055237|3242811|Superiority or Other||proportion estimate,binomial exact 95%CI|31.0|Standard Deviation|11.6|||2-Sided|95.0|11.0|58.7|||||As stated in the Outcome statistical Analysis 1. Section, the confidence interval was calculated using binomial exact statistics. The standard deviation is based on that calculation.||
1766410|NCT00054847|3242813|Superiority or Other||||||>|0.99|||||||Chi-squared||||
1766411|NCT00054847|3242814|Superiority or Other|||||||0.61|||||||Chi-squared||||
1766412|NCT00054847|3242815|Superiority or Other||Odds Ratio (OR)|1.07||||0.82|2-Sided|95.0|0.62|1.84||Multiple logistic regression analysis was used to adjust for stratification factors and characteristics that were potentially predictive of graft patency. We also performed prespecified subgroup analyses and assessed treatment subgroup interaction.|Chi-squared|We performed as-treated and per-protocol analyses & multiple imputations as sensitivity analyses to the intent-to-treat analysis on primary end point.||The study was designed to have 90% power to detect 1-year patency rates of 92% in radial artery vs 83% in saphenous vein grafts, with a 2-sided type I error of 5%and an expected 1-year catheterization completion rate of 65%.|
1766413|NCT00054717|3242848|Superiority or Other|||||||0.9894|||||||Log Rank||||
1766414|NCT00054717|3242888|Superiority or Other|||||||0.0001|||||||Log Rank||||
1766415|NCT00054717|3242889|Superiority or Other|||||||0.0001|||||||Log Rank||||
1766416|NCT00054717|3242890|Superiority or Other|||||||0.0001|||||||Log Rank||||
1766417|NCT00054717|3242891|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766418|NCT00054717|3242892|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766419|NCT00054717|3242893|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766420|NCT00054717|3242894|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766421|NCT00054717|3242895|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766422|NCT00054717|3242896|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766423|NCT00054717|3242897|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766424|NCT00054717|3242898|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766425|NCT00054717|3242899|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766426|NCT00054717|3242900|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766427|NCT00054717|3242901|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766428|NCT00054717|3242902|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766429|NCT00054717|3242903|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766430|NCT00054717|3242904|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766431|NCT00054717|3242905|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766432|NCT00054717|3242906|Superiority or Other|||||||0.0001|||||||Log Rank||||
1766433|NCT00054717|3242907|Superiority or Other|||||||0.0001|||||||Cochran-Mantel-Haenszel|Weighted by the size of enfuvirtide and protease inhibitor strata|||
1766434|NCT00054704|3242908|Superiority or Other||Mean Difference (Net)|-5.828|Standard Error of the Mean|3.182||0.086|2-Sided|95.0|-12.59|0.934||A linear mixed model included drug, visit and their interaction as fixed factors. Subject was a random factor. The test here is for the main effect of drug.|Mixed Models Analysis|Baseline score was a covariate. Restricted maximum likelihood estimates were used with a compound symmetry covariance structure.||The primary intent of this study was to compare the efficacy of riluzole to placebo in the treatment of overall depressive symptomatology of bipolar disorder subjects who were acutely depressed. Data from 8 riluzole and 11 placebo participants were analyzed due to missing data for one riluzole patient.|
1766435|NCT00054275|3242929|Superiority or Other||proportion of pts with partial response|0.39||||0.95|2-Sided|95.0|0.23|0.58|||confidence interval for partial response|Confidence interval for partial response rate using Wilson's Method|||
1766436|NCT00053846|3242965|Superiority or Other||Mean Difference (Final Values)|-0.483|Standard Error of the Mean|0.275||0.08|2-Sided|95.0|-1.02|0.0576|||ANCOVA||Multiple Imputation (MI) used for estimates. MICE software in R was used to generate 100 imputed datasets. ANCOVA was run on each, and results were pooled.|H0: The true difference in means is equal to zero. Ha: The true difference in means is not equal to zero.|
1766437|NCT00053703|3242971|Superiority or Other|||||||0.05|||||||Mixed Models Analysis||||
1766438|NCT00052910|3243011|Superiority or Other (legacy)||Cox Proportional Hazard|1.03|||||2-Sided|95.0|0.83|1.28|||||Adjusted Hazard Ratio, ECF vs 5-FU/LV||
1766439|NCT00052910|3243012|Superiority or Other (legacy)||Cox Proportional Hazard|0.99|||||2-Sided|95.0|0.79|1.24|||||Adjusted Hazard Ratio, ECF vs 5-FU/LV||
1766440|NCT00049543|3243022|Superiority or Other||Hazard Ratio (HR)|1.22||||0.15|2-Sided|95.0|0.93|1.61||Stratified by stratification factors at randomization (except center)|Log Rank|Stratified by stratification factors at randomization (except center)|||
1766441|NCT00049543|3243023|Superiority or Other||Hazard Ratio (HR)|1.24||||0.14|2-Sided|95.0|0.94|1.64|||Log Rank|||The Kaplan-Meier estimates of survival distribution for overall survival by treatment arm are reported, and the log rank test stratified by the stratification factors at randomization (exclude center) was used to compare the difference in the overall survival between two treatment arms. Hazard ratio of comparison of study treatment arm to placebo and it 95% C.I. were reported.|
1766442|NCT00049530|3243027|Superiority or Other||||||<|0.001|||||||bionomial proportion test|||It is of interest to test the null hypothesis of 10% plasma b-FGF response rate versus the alternative hypothesis of 30% response rate. Based on the sample size of 30 eligible patients, there will be 84% power to detect this 20% difference in b-FGF response rates. This was based on a two-sided type I error of .05, using the one-sample binomial test.|
1766443|NCT00048997|3243048|Superiority||Odds Ratio (OR)|2.52||||0.005|2-Sided|95.0|1.32|4.8|||Regression, Logistic|2-sided significance level = 0.05|Reference level = PCI arm|The development of CNS metastases was assessed using logistic regression modeling comparing presence vs. absence of brain metastases at 1 year.|
1766444|NCT00048997|3243049|Superiority|||||||0.11|||||||Other [Z-test, 2-sided]|Significance level = 0.05|||
1766445|NCT00048997|3243050|Superiority|||||||0.51|||||||Z-test, 2-sided|Significance level = 0.05|||
1766446|NCT00048997|3243051|Superiority|||||||0.52|||||||Z-test, 2-sided|Significance level = 0.05|||
1766447|NCT00048997|3243052|Superiority|||||||0.14|||||||Z-test, 2-sided|Significance level = 0.05|||
1766448|NCT00048997|3243053|Superiority|||||||0.2|||||||Z-test, 2-sided|Significance level = 0.05|||
1766449|NCT00048997|3243054|Superiority|||||||0.008|||||||Z-test, 2-sided|Significance level = 0.05|||
1766450|NCT00048997|3243055|Superiority|||||||0.01|||||||Z-test, 2-sided|2-sided significance level = 0.05|||
1766451|NCT00048997|3243056|Superiority or Other||Hazard Ratio (HR)|1.07||||0.2853|2-Sided|95.0|0.84|1.38||One-sided significance level of 0.025.|Log Rank||Prophylactic cranial irradiation (PCI) is the reference arm for the hazard ratio.|This study was designed to detect a 20% relative improvement in hazard rate: null hypothesis (observation): MST (median survival time) = 23.5 mo.; alternative hypothesis (PCI): MST= 29.4 mo. A one-sided log-rank test at a significance level of 0.025 would have 80% power to detect this difference with a sample size of 1007 patients (527 deaths were required for the final analysis).|
1766452|NCT00047385|3243061|Superiority or Other||Hazard Ratio (HR)|1.13|||||2-Sided|95.0|1.03|1.23|||||Denominator: LDCT Group Numerator: CXR Group||
1766492|NCT00045032|3243175|Superiority or Other||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.47|1.21|||||HR for Herceptin 1-Year Arm versus Observation Arm.||
1766453|NCT00047385|3243062|Superiority or Other||Hazard Ratio (HR)|0.933||||0.02|2-Sided|95.0|0.864|0.988||No adjustment for multiple comparisons. Only one analysis performed.|Weighted log-rank (details below)|Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.||Alternative hypothesis: LDCT screening reduced all-cause mortality relative to chest x-ray.|
1766454|NCT00047385|3243063|Superiority or Other||Hazard Ratio (HR)|0.8||||0.004|2-Sided|95.0|0.733|0.932||P-value is adjusted for multiple comparisons.|Weighted log-rank (details below)|Weights in weighted log-rank statistic increased linearly from zero at randomization to full weight at 4 years and thereafter.||"Alternative hypothesis: LDCT screening reduces lung cancer mortality relative to chest x-ray.~Power: 90% for a 20% reduction in lung cancer mortality."|
1766455|NCT00047008|3243077|Superiority or Other||Hazard Ratio (HR)|0.9||||0.18|2-Sided|95.0|0.719|1.128|||Log Rank|||A sample size of 684 analyzable patients provides 80% power to detect a relative reduction of 25% in the rate of death in the accelerated-fractionation radiotherapy group as compared with the standard-fractionation radiotherapy group, assuming a 2-year rate of overall survival of 45% in the standard-fractionation radiotherapy group, with the use of a one-sided log-rank test at the 0.05 significance level.|
1766456|NCT00046930|3243078|Superiority or Other||Odds Ratio (OR)|1.12||||0.617|2-Sided|95.0|0.77|1.65||Test was stratified on age and type of leukemia.|Mantel Haenszel||Zosuquidar/Placebo|Test of difference in the CR (complete remission) rate between the arms.|
1766457|NCT00046930|3243079|Superiority or Other|||||||0.16|||||||Log Rank|Stratified on age and type of leukemia|||
1766458|NCT00046930|3243080|Superiority or Other|||||||0.28|||||||Log Rank|Stratified on age (< 70 vs. >=70) and type of leukemia (de novo AML, secondary RAEB-t, or secondary RAEB AML)||The study was designed to have 80% power to detect a non-proportional hazards difference in OS at the one-sided 0.025 significance level of 30.2% vs 39.6%, 12.8% vs 27.1% and 7.0% vs 14.0% at 1 years, 2 years, and full information for zosuquidar and placebo, respectively.|
1766459|NCT00046891|3243086|Superiority or Other|||||||0.84|||||||t-test, 2 sided|||Total HSCS Area Under the Curve (AUC) scores between the two treatment arms.|
1766460|NCT00045435|3243116|Other||percent|6.0|||||1-Sided|80.0|1.0||||||The stopping criterion was not met.|The study was to be stopped if the lower bound of a 1-sided 80% confidence interval for NRM was greater than 15%|
1766461|NCT00045435|3243117|Other||Percent|47.0|||||1-Sided|95.0||69.0|||||The criterion for stopping was not met.|The study was to be stopped after 20 patients if the upper bound of a 1-sided 95% confidence interval for relapse-free survival was <35%.|
1766462|NCT00045032|3243149|Superiority or Other||Hazard Ratio (HR)|0.97||||0.7251|2-Sided|95.0|0.84|1.13|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.||
1766463|NCT00045032|3243151|Superiority or Other||Hazard Ratio (HR)|0.96||||0.6823|2-Sided|95.0|0.8|1.15|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.||
1766464|NCT00045032|3243153|Superiority or Other||Hazard Ratio (HR)|0.69|||||2-Sided|95.0|0.59|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.||
1766465|NCT00045032|3243153|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1766466|NCT00045032|3243153|Superiority or Other||Hazard Ratio (HR)|0.72|||<||2-Sided|95.0|0.62|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.||
1766467|NCT00045032|3243153|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1766468|NCT00045032|3243155|Superiority or Other||Hazard Ratio (HR)|0.94||||0.45|2-Sided|95.0|0.8|1.1|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.||
1766469|NCT00045032|3243157|Superiority or Other||Hazard Ratio (HR)|0.69|||||2-Sided|95.0|0.61|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.||
1766470|NCT00045032|3243157|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1766471|NCT00045032|3243157|Superiority or Other||Hazard Ratio (HR)|0.73|||<||2-Sided|95.0|0.64|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.||
1766472|NCT00045032|3243157|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1766473|NCT00045032|3243159|Superiority or Other||Hazard Ratio (HR)|1.0||||0.9626|2-Sided|95.0|0.85|1.17|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.||
1766474|NCT00045032|3243161|Superiority or Other||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.65|0.85|||||HR for Herceptin 2-Year Arm versus Observation Arm.||
1766475|NCT00045032|3243161|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1766476|NCT00045032|3243161|Superiority or Other||Hazard Ratio (HR)|0.76|||<||2-Sided|95.0|0.67|0.87|||||HR for Herceptin 1-Year Arm versus Observation Arm.||
1766477|NCT00045032|3243161|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1766478|NCT00045032|3243163|Superiority or Other||Hazard Ratio (HR)|0.94||||0.4755|2-Sided|95.0|0.8|1.11|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.||
1766479|NCT00045032|3243165|Superiority or Other||Hazard Ratio (HR)|0.69|||||2-Sided|95.0|0.61|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.||
1766480|NCT00045032|3243165|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1766481|NCT00045032|3243165|Superiority or Other||Hazard Ratio (HR)|0.73|||<||2-Sided|95.0|0.64|0.83|||||HR for Herceptin 1-Year Arm versus Observation Arm.||
1766482|NCT00045032|3243165|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1766483|NCT00045032|3243167|Superiority or Other||Hazard Ratio (HR)|1.01||||0.9156|2-Sided|95.0|0.84|1.21|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.||
1766484|NCT00045032|3243169|Superiority or Other||Hazard Ratio (HR)|0.72|||||2-Sided|95.0|0.62|0.83|||||HR for Herceptin 2-Year Arm versus Observation Arm.||
1766485|NCT00045032|3243169|Superiority or Other||Hazard Ratio (HR)|0.74|||||2-Sided|95.0|0.64|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.||
1766486|NCT00045032|3243171|Superiority or Other||Hazard Ratio (HR)|0.74|||||2-Sided|95.0|0.63|0.86|||||HR for Herceptin 2-Year Arm versus Observation Arm.||
1766487|NCT00045032|3243171|Superiority or Other|||||||0.0001|||||||Log Rank||||
1766488|NCT00045032|3243171|Superiority or Other||Hazard Ratio (HR)|0.76|||||2-Sided|95.0|0.65|0.88|||||HR for Herceptin 1-Year Arm versus Observation Arm.||
1766489|NCT00045032|3243171|Superiority or Other|||||||0.0005|||||||Log Rank||||
1766490|NCT00045032|3243174|Superiority or Other||Hazard Ratio (HR)|0.47|||||2-Sided|95.0|0.28|0.79|||||HR for Herceptin 2-Year Arm versus Observation Arm.||
1766491|NCT00045032|3243174|Superiority or Other|||||||0.003|||||||Log Rank||||
1766493|NCT00045032|3243175|Superiority or Other|||||||0.2379|||||||Log Rank||||
1766494|NCT00045032|3243177|Superiority or Other||Hazard Ratio (HR)|1.02||||0.7962|2-Sided|95.0|0.89|1.17|||Log Rank||HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.||
1766495|NCT00045032|3243184|Superiority or Other||Hazard Ratio (HR)|0.77|||||2-Sided|95.0|0.69|0.87|||||HR for Herceptin 2-Year Arm versus Observation Arm.||
1766496|NCT00045032|3243184|Superiority or Other||Hazard Ratio (HR)|0.76|||||2-Sided|95.0|0.68|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.||
1766497|NCT00045032|3243189|Superiority or Other||Hazard Ratio (HR)|0.75|||||2-Sided|95.0|0.67|0.85|||||HR for Herceptin 2-Year Arm versus Observation Arm.||
1766498|NCT00045032|3243189|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1766499|NCT00045032|3243189|Superiority or Other||Hazard Ratio (HR)|0.76|||<||2-Sided|95.0|0.67|0.86|||||HR for Herceptin 1-Year Arm versus Observation Arm.||
1766500|NCT00045032|3243189|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1766501|NCT00045032|3243192|Superiority or Other||Hazard Ratio (HR)|0.43|||||2-Sided|95.0|0.34|0.53|||||HR for Herceptin 2-Year Arm versus Observation Arm.||
1766502|NCT00045032|3243192|Superiority or Other|||||||0|||||||Log Rank||||
1766503|NCT00045032|3243193|Superiority or Other||Hazard Ratio (HR)|0.54|||||2-Sided|95.0|0.44|0.67|||||HR for Herceptin 1-Year Arm versus Observation Arm.||
1766504|NCT00045032|3243193|Superiority or Other||||||<|0.0001|||||||Log Rank||||
1766505|NCT00042991|3243202|Superiority or Other|||||||0.18|||||||Wilcoxon (Mann-Whitney)||||
1766506|NCT00042991|3243203|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1766507|NCT00042991|3243204|Superiority or Other|||||||0.0546|||||||Wilcoxon (Mann-Whitney)|||19 patients had Enhancing tumor at both Baseline and Post-RT time points. Thus, the following test was based on these 19 patients.|
1766508|NCT00042991|3243205|Superiority or Other||||||<|0.0001|||||||Wilcoxon (Mann-Whitney)||||
1766509|NCT00041119|3243217|Non-Inferiority or Equivalence|Power calculations were designed to detect effects in the marginal distributions of the two study factors, agent and length, and assume no interaction between the two factors. Calculations also assume exponential DFS and a total of 4556 treated patients accrued over 29 months and followed for four years after accrual termination for a total study time of 6.4 years.|Hazard Ratio (HR)|1.12|||||2-Sided|95.0|0.84|1.49|||||||
1766510|NCT00041119|3243221|Non-Inferiority or Equivalence|Power calculations were designed to detect effects in the marginal distributions of the two study factors, agent and length, and assume no interaction between the two factors. Calculations also assume exponential DFS and a total of 4556 treated patients accrued over 29 months and followed for four years after accrual termination for a total study time of 6.4 years. We assume the 5-year DFS of CA therapy is 88% and 84.7% for T. These assumptions are based upon results of SWOG 8897.|Hazard Ratio (HR)|1.27|||||1-Sided|95.0||1.56|||||||
1766511|NCT00041119|3243222|Equivalence|For T to be considered equivalent to the standard CA, a confidence interval of the hazard ratio of T to CA should be wholly to the left of 1.3, corresponding to a 30% increase in hazard rate. If the 5-year DFS for CA is 88% then an increase of 30% in hazard rate for T corresponds to 5-year DFS of 84.7%. The null hypothesis is that the hazard ratio of T to CA exceeds 1.3. The alternative hypothesis is that the two hazard rates are equivalent.|Hazard Ratio (HR)|1.26|||||1-Sided|95.0||1.48|||||||
1766512|NCT00041119|3243223|Superiority|If the 5-year DFS for 4 cycles is 84.7% then a decrease of 23% in hazard rate for 6 cycles corresponds to an increase in 5-year DFS to 88%. Assuming a 2-sided significance level of 0.05, there is 90.9% power to detect such an increase at the final analysis conducted 6.4 years after study activation.|Hazard Ratio (HR)|1.03|||||2-Sided|95.0|0.84|1.28||||||The null hypothesis is that the hazards of both 6 and 4 cycle regimens are equal. The alternative hypothesis is a hazard ratio of 0.77, corresponding to a decrease of 23% in hazard due to longer duration of chemotherapy.|
1766513|NCT00040937|3243229|Superiority or Other||4-yr survival (%)|64.0|||||2-Sided|95.0|55.0|74.0||||||The study was designed to have 82% power for detecting a 50% improvement in survival from a median of 4 years, as observed in SWOG S9321.|
1766514|NCT00040742|3243236|Superiority or Other||Mean Difference (Final Values)|-0.35|Standard Error of the Mean|0.14||0.013|2-Sided||||||Mixed Models Analysis|Contrasts used for estimation.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (any ginger - placebo). Negative values are favorable for the ginger group.|"Placebo vs Any Ginger. H0: Mean difference between [(0.5g +1.0g +1.5g) / 3] and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between [(0.5g +1.0g +1.5g) / 3] and placebo of change from baseline of Average Acute Nausea > 0. (Two-sided)"|
1766515|NCT00040742|3243236|Superiority or Other||Mean Difference (Final Values)|-0.158|Standard Error of the Mean|0.12||0.738|2-Sided|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea > 0. (Two-sided)"|
1766516|NCT00040742|3243236|Superiority or Other||Mean Difference (Final Values)|-0.402|Standard Error of the Mean|0.124||0.076|2-Sided|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea > 0. (Two-sided)"|
1766535|NCT00026312|3243331|Superiority or Other (legacy)||Mean Difference (Net)|0.0||||0.0262|2-Sided|95.0|||||Wilcoxon (Mann-Whitney)|||The number of courses of therapy delivered or patients randomized to Regimen B - RA + Immunotherapy and non-randomly assigned to Regimen B after halting of randomization, excluding patients with persistent disease, were compared using the Wilcoxon rank-sum test.|
1766591|NCT00004859|3243574|Superiority or Other|||||||0.99|||||||Log Rank||||
1766860|NCT00048542|3244083|Superiority or Other|||||||0.028|||||||Pearson's Chi-square test||||
1766517|NCT00040742|3243236|Superiority or Other||Mean Difference (Final Values)|-0.441|Standard Error of the Mean|0.127||0.046|2-Sided|||||The p-value was adjusted using theTukey-Kramer method|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (0.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea = 0.~Ha: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea > 0. (Two-sided)"|
1766518|NCT00040742|3243237|Superiority or Other||Mean Difference (Final Values)|-0.47|Standard Error of the Mean|0.16||0.003|2-Sided||||||Mixed Models Analysis|Parameter estimated using a contrast.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (any ginger - placebo). Negative values are favorable for the ginger group.|"Placebo vs. Any Ginger. H0: Mean difference between [(0.5g +1.0g +1.5g) / 3] and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between [(0.5g +1.0g +1.5g) / 3] and placebo of change from baseline of Peak Acute Nausea > 0. (Two-sided)"|
1766519|NCT00040742|3243237|Superiority or Other||Mean Difference (Final Values)|-0.269|Standard Error of the Mean|0.137||0.431|2-Sided|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea > 0. (Two-sided)"|
1766520|NCT00040742|3243237|Superiority or Other||Mean Difference (Final Values)|-0.506|Standard Error of the Mean|0.141||0.036|2-Sided|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (1 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea > 0. (Two-sided)"|
1766521|NCT00040742|3243237|Superiority or Other||Mean Difference (Final Values)|-0.566|Standard Error of the Mean|0.145||0.017|2-Sided|||||The p-value was adjusted using theTukey-Kramer method.|Mixed Models Analysis|Mixed model analyses and Type 3 tests of fixed effects using the Kenward-Roger degrees of freedom procedure were used.|The estimation parameter (mean difference) is the difference in mean change from baseline (post-intervention - baseline) between groups (0.5 gm ginger - placebo). Negative values are favorable for the ginger group.|"H0: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea = 0.~Ha: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea > 0. (Two-sided)"|
1766522|NCT00033657|3243253|Superiority or Other|||||||0.48|||||||Log Rank||||
1766523|NCT00033631|3243260|Superiority or Other (legacy)|||||||0.29||||||Two-sided significance level = 0.05|Chi-squared||||
1766524|NCT00033631|3243261|Superiority or Other (legacy)||Hazard Ratio (HR)|0.65||||0.051|2-Sided|95.0|0.42|1.01||Two-sided significance level = 0.05|Gray's test||Reference level is the 70.2 Gy level||
1766525|NCT00033631|3243262|Superiority or Other (legacy)||Hazard Ratio (HR)|0.41||||0.0001|2-Sided|95.0|0.25|0.66|||Gray's test|Two-sided significance level = 0.05|Reference level = 70.2 Gy arm||
1766526|NCT00033631|3243263|Superiority or Other (legacy)||Hazard Ratio (HR)|0.66||||0.14|2-Sided|95.0|0.38|1.15|||Gray's test|Two-sided significance level = 0.05|Reference level is 70.2 Gy arm||
1766527|NCT00033631|3243264|Superiority or Other (legacy)||Hazard Ratio (HR)|0.59|||<|0.0001|2-Sided|95.0|0.5|0.7||Two-sided significance level = 0.05|Gray's test|Reference arm is 70.2 Gy arm|||
1766528|NCT00033631|3243265|Superiority or Other (legacy)||Hazard Ratio (HR)|1.0||||0.98|2-Sided|95.0|0.83|1.2||Two-sided test, significance level = 0.05|Log Rank||Reference level = 70.2 Gy arm|The original target sample size was 1520 patients with a requirement of 715 deaths to test the hypothesis of overall survival (OS) efficacy of the 79.2 Gy arm. The trial was designed to detect a hazard ratio (HR) of 1.30 (standard/high-dose) with 90% statistical power at a one-sided significance level of 0.025.|
1766529|NCT00033293|3243285|Other|The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.|Mean Difference (Net)|16.75||||0.2364|1-Sided||||||t-test, 1 sided||||
1766530|NCT00033293|3243286|Other||Mean Difference (Net)|60.1979||||0.0919|1-Sided||||||t-test, 1 sided|||The two samples from the respective treatment arms were compared using a one-sided t-test with a significance level of .05.|
1766531|NCT00033293|3243287|Other||Chi-squared test statistic|8.125||||0.0044|2-Sided|95.0||||No adjustments for multiple comparisons.|Chi-squared|A two-way test with a null hypothesis of no association, using SAS 9.4.||"The 5 categories of OMA ratings are: stance, gait, arm & hand function, opsoclonus, & mood/behavior. For each category, a patient's response will be based on a comparison of the baseline evaluation to the best of 3 time points: 2 months, 6 months & 1 year. If a patient crosses over to the IVIG arm or switches to ACTH at any time, the patient will be considered a non-responder. The proportion of responders from the 2 treatment arms were compared using a chi-squared test."|
1766532|NCT00030901|3243295|Superiority or Other|||||||0.73||||||P-value is adjusted for stratification factors age older than 60, African American, baseline PSA, and vitamin E supplementation.|Regression, Logistic|||With target sample size of 466 randomized patients (233 per arm), there is a 90% of power to detect a one-third reduction in the three-year incidence rate of prostate cancer. The alpha level is set at 0.025, one-sided.|
1766533|NCT00026312|3243330|Superiority or Other (legacy)||Log-Rank Test Statistic|4.1362||||0.042|2-Sided|95.0|||||Log Rank|||The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.|
1766534|NCT00026312|3243330|Superiority or Other (legacy)||Log Rank Test Statistic|3.4471||||0.0634|2-Sided|95.0|||||Log Rank|||The overall survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.|
1766536|NCT00026312|3243334|Superiority or Other (legacy)||Log Rank Test Statistic|2.6176||||0.1057|2-Sided|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy for the subgroup of patients with INSS Stage 4 disease were compared using the log-rank test.|
1766537|NCT00026312|3243335|Superiority or Other (legacy)||Log Rank Test Statistic|2.6803||||0.1016|2-Sided|95.0|||||Log Rank|||The event-free survival distributions of patients randomized to Regimen A - RA Only and randomized to Regimen B - RA + Immunotherapy were compared using the log-rank test.|
1766538|NCT00024102|3243381|Superiority or Other||Hazard Ratio (HR)|1.85||||0.02|2-Sided|95.0|1.11|3.08||Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. There is no adjustment for multiple comparisons.|Regression, Cox||||
1766539|NCT00024102|3243382|Non-Inferiority or Equivalence|The primary measure of efficacy was the hazard ratio for disease recurrence or death in the capecitabine group as compared with the standard chemotherapy group. Capecitabine would be considered noninferior to standard chemotherapy if the hazard ratio was greater than 0.8046. (With the use of a 5-year landmark for descriptive purposes, this ratio corresponds to a 5-year rate of relapse-free survival of 60% for standard chemotherapy and 53% for capecitabine.)|Hazard Ratio (HR)|2.09|||<|0.001|2-Sided|95.0|1.38|3.17||Multivariate proportional hazards regression used to test for an arm effect was adjusted for tumor size, number of lymph nodes and hormone-receptor status. A priori formal monitoring for futility and noninferiority was planned at accrual milestones|Regression, Cox||||
1766540|NCT00022516|3243425|Superiority or Other||Hazard Ratio (HR)|0.78||||0.06|2-Sided|95.0|0.6|1.01|||Log Rank||||
1766541|NCT00022516|3243426|Superiority or Other||Hazard Ratio (HR)|0.85||||0.3178|2-Sided|95.0|0.62|1.17|||Log Rank||||
1766542|NCT00022516|3243427|Superiority or Other||Hazard Ratio (HR)|0.87||||0.357|2-Sided|95.0|0.65|1.17|||Log Rank||||
1766543|NCT00022516|3243428|Superiority or Other||Hazard Ratio (HR)|0.84||||0.14|2-Sided|95.0|0.6|1.06|||Log Rank||||
1766544|NCT00019682|3243450|Non-Inferiority|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||SDS scale|
1766545|NCT00019682|3243450|Non-Inferiority|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||SF-36 scale|
1766546|NCT00019682|3243450|Non-Inferiority|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||FACT-F scale|
1766547|NCT00019682|3243450|Non-Inferiority|Evaluated inferiority in quality of life outcomes between arms.|||||>|0.05|||||||Mixed Models Analysis|||FACT-G scale|
1766548|NCT00019682|3243451|Superiority||||||>|0.05|||||||Fisher Exact||||
1766549|NCT00019682|3243452|Superiority|||||||0.008||||||Unadjusted 2 tail p value.|Log Rank||||
1766550|NCT00019682|3243453|Superiority|||||||0.035|||||||Chi-squared||||
1766551|NCT00014222|3243479|Superiority|||||||0.084|||||||Log Rank||||
1766552|NCT00014222|3243480|Superiority|||||||0.0007|||||||Log Rank||||
1766553|NCT00008385|3243504|Superiority or Other|||||||0.154|||||||Log Rank||||
1766554|NCT00008385|3243505|Superiority or Other|||||||0.069|||||||Log Rank||||
1766555|NCT00008385|3243506|Superiority or Other||Risk Ratio (RR)|1.25||||0.294|2-Sided|95.0|0.64|2.37||This p value should be compared to the nominal p value of 0.0035 adjusting for the previous interim analyses|Log Rank||The 95% confidence interval was repeated confidence interval for the risk ratio||
1766556|NCT00006721|3243514|Superiority or Other||Hazard Ratio (HR)|1.55||||0.08|2-Sided|95.0|0.95|2.54|||Regression, Cox|adjusting for the stratification factor (serum beta-2 microglobulin level)|CHOP + Tositumomab versus CHOP + Rituximab||
1766557|NCT00006721|3243518|Superiority or Other||Hazard Ratio (HR)|0.79||||0.11|2-Sided|95.0|0.6|1.05|||Regression, Cox|adjusting for the stratification factor (serum beta-2 microglobulin level)|CHOP + Tositumomab versus CHOP + Rituximab||
1766558|NCT00006392|3243523|Superiority or Other||Risk Ratio (RR)|0.99|||>|0.05|2-Sided|99.0|0.89|1.1||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.||
1766559|NCT00006392|3243523|Superiority or Other||Risk Ratio (RR)|1.02|||>|0.05|2-Sided|99.0|0.92|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.||
1766560|NCT00006392|3243523|Superiority or Other||Risk Ratio (RR)|0.98|||>|0.05|2-Sided|99.0|0.88|1.09||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Chi-squared||The placebo was the denominator.||
1766561|NCT00006392|3243524|Superiority or Other||Hazard Ratio (HR)|0.94|||>|0.05|2-Sided|99.0|0.77|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox|||Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.|
1766562|NCT00006392|3243524|Superiority or Other||Hazard Ratio (HR)|0.99|||>|0.05|2-Sided|99.0|0.82|1.19||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.|
1766563|NCT00006392|3243524|Superiority or Other||Hazard Ratio (HR)|0.93|||>|0.05||99.0|0.77|1.13||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo is the denominator.|Only results from overall survival are presented as the number of cancer-specific deaths is too few to be meaningful.|
1766564|NCT00006392|3243525|Superiority or Other||Hazard Ratio (HR)|1.02|||>|0.05||99.0|0.9|1.16||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.|
1766565|NCT00006392|3243525|Superiority or Other||Hazard Ratio (HR)|1.01|||>|0.05|2-Sided|99.0|0.89|1.15||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.|
1766566|NCT00006392|3243525|Superiority or Other||Hazard Ratio (HR)|1.03|||>|0.05|2-Sided|99.0|0.91|1.17||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The power to look at all cancer incidence is greater than 90%.|
1766567|NCT00006392|3243526|Superiority or Other||Hazard Ratio (HR)|1.28|||>|0.05|2-Sided|99.0|0.82|2.0||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.|
1766568|NCT00006392|3243526|Superiority or Other||Hazard Ratio (HR)|1.05|||>|0.05|2-Sided|99.0|0.66|1.67||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.|
1766569|NCT00006392|3243526|Superiority or Other||Hazard Ratio (HR)|1.09|||>|0.05|2-Sided|99.0|0.69|1.73||A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.|The trial was designed to study prostate cancer and colorectal cancer has a lower incidence rate, there was limited power to look at colorectal cancer incidence.|
1766570|NCT00006392|3243527|Superiority or Other||Hazard Ratio (HR)|1.16|||>|0.01|2-Sided|99.0|0.9|1.16||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.||
1766571|NCT00006392|3243527|Superiority or Other||Hazard Ratio (HR)|1.12|||>|0.01|2-Sided|99.0|0.73|1.72||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.||
1766572|NCT00006392|3243527|Superiority or Other||Hazard Ratio (HR)|1.0|||>|0.05||99.0|0.64|1.55||The trial was designed to study prostate cancer and lung cancer has a lower incidence rate, there was limited power to look at lung cancer incidence. A 99% CI (rather than a 95% CI) was used to adjust for the multiple comparisons.|Regression, Cox||The placebo was the denominator.||
1766573|NCT00006392|3243528|Superiority or Other||Hazard Ratio (HR)|1.05|||<|0.01||99.0|0.88|1.25||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 99% power to detect a 44% reduction in prostate cancer for combination vs. Placebo.|
1766574|NCT00006392|3243528|Superiority or Other||Hazard Ratio (HR)|1.04|||<|0.01|2-Sided|99.0|0.87|1.24||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.|
1766575|NCT00006392|3243528|Superiority or Other||Hazard Ratio (HR)|1.13|||<|0.01|2-Sided|99.0|0.95|1.35||The p-value was adjusted for multiple comparisons.|Regression, Cox|||Per study design, with a sample size of 32,400 men, using a 1-sided alpha=.005 level (equivalent to a 2-sided alpha=.01 level) there was 96% power to detect a 25% reduction in prostate cancer for either agent vs. Placebo.|
1766576|NCT00006237|3243539|Superiority or Other|||||||0.02|||||||Log Rank||||
1766577|NCT00006237|3243540|Superiority or Other|||||||0.49|||||||Log Rank||||
1766578|NCT00006011|3243548|Superiority or Other||Hazard Ratio (HR)|0.9|||||2-Sided|95.0|0.69|1.17||||||"Primary outcome is measured as a treatment hazard ratio stratified by stage and assuming proportional hazards.~Recurrence-free survival hazard ratio: Arm 2 is relative to Arm 1."|
1766579|NCT00005957|3243549|Superiority or Other (legacy)||Hazard Ratio (HR)|0.76||||0.01|2-Sided|95.0|0.61|0.94|||Log Rank||||
1766580|NCT00005957|3243550|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.38|2-Sided|95.0|0.72|1.13|||Log Rank||Hazard ratio (HR) estimation is for Standard Breast Irradiation arm versus Breast Radiation plus regional radiation arm.|It was estimated that the actuarial five year survival of patients on the control arm of this trial would be 80% and a 5% increase in five year survival with experiment arm is clinically interesting to detect. A sample size of 1832 will ensure 80% power to detect such a difference with two-sided alpha of 0.05.|
1766581|NCT00005044|3243562|Superiority||Hazard Ratio (HR)|0.91||||0.62|2-Sided|95.0|0.64|1.3|||Log Rank|2-sided significance level = 0.05|Reference level = TAS x 8 weeks||
1766582|NCT00005044|3243563|Superiority||Hazard Ratio (HR)|0.97||||0.77|2-Sided|95.0|0.79|1.19|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Phoenix definition|
1766583|NCT00005044|3243563|Superiority||Hazard Ratio (HR)|1.02||||0.74|2-Sided|95.0|0.89|1.17|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Protocol definition|
1766584|NCT00005044|3243564|Superiority||Hazard Ratio (HR)|1.07||||0.8|2-Sided|95.0|0.68|1.66|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Distant metastasis|
1766585|NCT00005044|3243564|Superiority||Hazard Ratio (HR)|0.65||||0.07|2-Sided|95.0|0.4|1.05|||Gray's test|2-sided significance level = 0.05|Reference level = TAS x 8 weeks|Locoregional progression|
1766586|NCT00005044|3243565|Superiority||Hazard Ratio (HR)|0.96||||0.47|2-Sided|95.0|0.85|1.08|||Log Rank|Significance level = 0.05|Reference level = TAS x 8 weeks||
1766587|NCT00005044|3243566|Superiority||Hazard Ratio (HR)|0.95||||0.62|2-Sided|95.0|0.79|1.15|||Log Rank|2-sided significance level of 0.05|Reference level = TAS x 8 weeks|With 1540 patients accrued over 4 years and observed for an additional 6 years, determined for the primary endpoint, there would be 90% power to detect a 22% reduction in the hazard of all cause deaths in the 28-week arm, with 2-sided significance level of 0.05. This sample accounted for a 10% ineligible/lack-of-data rate.|
1766588|NCT00005044|3243567|Superiority||Hazard Ratio (HR)|0.81||||0.45|2-Sided|95.0|0.48|1.39|||Log Rank||Reference level = TAS x 8 weeks|Assuming 40% of deaths in the 8-wk arm from prostate cancer (PC) and that 8-yr DSS would be 79%, 270 PC deaths were required to detect a 33% hazard reduction in the 28-wk arm with 90% power using the log-rank test with a 2-sided significance level of 0.05. Under assumed failure rates, 1,540 patients accrued over 4 years and observed for an additional 6 years were expected to provide the requisite events. This sample accounted for a 10% ineligible/lack-of-data rate and 3 interim analyses.|
1766589|NCT00004888|3243572|Superiority or Other||Overall Response Rate|0.457|||||2-Sided|95.0|0.309|0.61|||||||
1766590|NCT00004888|3243572|Superiority or Other||Overall Response Rate|0.474|||||2-Sided|95.0|0.31|0.642|||||||
1766592|NCT00004259|3243577|Superiority||Hazard Ratio (HR)|1.29||||0.41|2-Sided|95.0|0.7|2.35|||Log Rank|Two-sided confidence interval = 0.5|Reference level = Methylated||
1766593|NCT00004259|3243578|Superiority||Hazard Ratio (HR)|1.78||||0.08|2-Sided|95.0|0.93|3.4|||Log Rank|Two-side significance level = 0.05|Reference level = Methylated MGMT||
1766594|NCT00004259|3243579|Superiority|||||||0.76||||||2-sided|Chi-squared|||Non-hematologic toxicity|
1766595|NCT00004259|3243579|Superiority||||||<|0.001||||||2-sided|Chi-squared|||Overall toxicity|
1766596|NCT00004259|3243580|Superiority||Hazard Ratio (HR)|0.8||||0.46|2-Sided|95.0|0.55|1.16||2-sided|Gray's test||Reference level = RT + BCNU/CCNU||
1766597|NCT00004259|3243582|Superiority||Hazard Ratio (HR)|0.94||||0.36|2-Sided|95.0|0.67|1.32|||Log Rank|||The hypothesized median survival time was 36 months for the RT+BCNU/CCNU arm and 54 months for the RT+TMZ arm, corresponding to a hazard ratio (HR) of 0.67. A sample size of 216 evaluable patients per arm would provide 90% power with a one-sided significance level of 0.05. The final analysis was planned after 155 deaths were observed. Interim efficacy analyses were planned after 52 and 104 deaths, with an interim futility analysis planned at 128 deaths.|
1766598|NCT00004228|3243584|Superiority or Other|||||||0.63|||||||Regression, Cox|||A Cox model was used to assess evidence of a difference in event-free survival comparing A1+B1 (“1: no intensification”) to A2 +B2 (“2: intensification”), while adjusting for the other intervention through stratification.|
1766599|NCT00004228|3243584|Superiority or Other|||||||0.97|||||||Regression, Cox|||A Cox model was used to assess evidence of a difference in event-free survival comparing regimens A1+A2 (“A: CCG BFM”) to regimens B1+B2 (“B: NHL/BFM-95”) while adjusting for the other intervention through stratification.|
1766600|NCT00004124|3243594|Superiority||Hazard Ratio (HR)|1.01||||0.94|2-Sided|95.0|0.8|1.27|||Regression, Cox||||
1766601|NCT00004124|3243595|Superiority||Hazard Ratio (HR)|1.06||||0.7|2-Sided|95.0|0.79|1.43|||Regression, Cox||||
1766602|NCT00004054|3243604|Superiority||Hazard Ratio (HR)|0.94||||0.61|2-Sided|95.0|0.75|1.19|||Log Rank|2-sided significance level = 0.05|Cox proportional hazards model was used to obtain the hazard ratio. Reference level = Hormones and RT.||
1766603|NCT00004054|3243605|Superiority||Hazard Ratio (HR)|0.81||||0.42|2-Sided|95.0|0.48|1.36|||Gray's test|2-sided significance level = 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.||
1766604|NCT00004054|3243606|Superiority||Hazard Ratio (HR)|0.56||||0.09|2-Sided|95.0|0.28|1.1|||Gray's test|2-sided significance level = 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.||
1766605|NCT00004054|3243607|Superiority||Hazard Ratio (HR)|0.97||||0.82|2-Sided|95.0|0.74|1.27|||Gray's test|2-sided significance level of 0.05|Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.||
1766606|NCT00004054|3243608|Superiority or Other (legacy)||Hazard Ratio (HR)|1.04||||0.81|2-Sided|95.0|0.76|1.43|||Log Rank|||The original target sample size was 1440 patients with a requirement of 340 deaths to test the hypothesis of overall survival (OS) efficacy of the hormones and RT plus chemotherapy arm; the design is based on detecting a 6% absolute improvement in 5-year OS from 79% to 85%, or a 33% relative reduction in the yearly hazard rate, with 90% power and a 2-sided significance level of 0.05.|
1766607|NCT00003901|3243611|Superiority or Other||Cox Proportional Hazard|0.78||||0.332|2-Sided|95.0|0.48|1.28|||Regression, Cox||||
1766608|NCT00003901|3243612|Superiority or Other||Cox Proportional Hazard|1.63||||0.009|2-Sided|95.0|1.13|2.36|||Regression, Cox||||
1766609|NCT00003901|3243613|Superiority or Other||Cox Proportional Hazard|1.03||||0.886|2-Sided|95.0|0.69|1.54|||Regression, Cox||||
1766610|NCT00003901|3243614|Superiority or Other||Cox Proportional Hazard|1.59||||0.007|2-Sided|95.0|1.13|2.23|||Regression, Cox||||
1766611|NCT00003869|3243623|Superiority or Other|||||||0.18|||||||Fisher Exact||||
1766612|NCT00003869|3243624|Superiority or Other|||||||0.04|||||||Fisher Exact||||
1766613|NCT00003869|3243625|Superiority or Other|||||||0.5|||||||Log Rank||||
1766614|NCT00003869|3243626|Superiority or Other|||||||0.18|||||||Fisher Exact||||
1766615|NCT00003869|3243627|Superiority or Other|||||||0.54|||||||Log Rank||||
1766616|NCT00003641|3243645|Superiority or Other|||||||0.558|||||||Log Rank|Stratified on the stratification factors used for randomization|||
1766617|NCT00003641|3243646|Superiority or Other|||||||0.964|||||||Log Rank|stratified on the stratification factors used for randomization|||
1766618|NCT00003404|3243693|Other||rate of occurance|0.35|||||2-Sided|95.0|0.0|8.0|||||The local recurrence rate was estimated by dividing the number of recurrences by the total sample size. An exact 95% confidence interval (95% CI) for this rate was determined by binomial distribution.||
1766619|NCT00003389|3243695|Superiority or Other|||||||0.86|||||||Log Rank|Stratified log rank test was performed.|||
1766620|NCT00003389|3243696|Superiority or Other|||||||0.32|||||||Log Rank|Stratified log rank test was performed.|||
1766621|NCT00002874|3243710|Superiority|||||||0.029|||||||Chi-squared|||Hormone therapy and late radiotherapy toxicity|
1766622|NCT00002874|3243710|Superiority|||||||0.06|||||||Chi-squared|||Acute radiotherapy toxicity|
1766623|NCT00002874|3243711|Superiority||Cox Proportional Hazard|0.6|||<|0.001|2-Sided|95.0|0.5|0.71|||Log Rank|One-side test|||Reference level = placebo arm
1766624|NCT00002874|3243712|Superiority||Hazard Ratio (HR)|0.49|||<|0.001|2-Sided|95.0|0.32|0.74|||Gray’s test|One-sided test|Reference level = placebo arm||
1766625|NCT00002874|3243713|Superiority||Hazard Ratio (HR)|0.63||||0.002|2-Sided|95.0|0.46|0.87|||Gray’s test|One-sided test|Reference level = placebo arm||
1766626|NCT00002874|3243714|Superiority||||||<|0.001|||||||Chi-squared||||
1766627|NCT00002874|3243715|Superiority||Hazard Ratio (HR)|1.11||||0.213|2-Sided|95.0|0.85|1.46|||Gray’s test|One-sided test|Reference level = placebo arm||
1766628|NCT00002874|3243716|Superiority||Hazard Ratio (HR)|0.48|||<|0.001|2-Sided|95.0|0.4|0.58|||Gray’s test|One-sided test|Reference level = placebo arm||
1766629|NCT00002874|3243717|Superiority||Cox Proportional Hazard|1.1||||0.289|2-Sided|95.0|0.79|1.53|||Gray’s test|One-sided test|||Reference level = placebo arm
1766861|NCT00048542|3244083|Superiority or Other|||||||0.103|||||||Pearson's Chi-square test||||
1766630|NCT00002874|3243718|Superiority||Hazard Ratio (HR)|0.77||||0.02|2-Sided|95.0|0.59|0.98||One-sided significance level = 0.046 to preserve overall significance level of 0.05 for the study.|Log Rank||Stratifying variables were fixed covariates: prior hormone therapy (yes/no), entry prostate-specific antigen (PSA) (1.6-4.0 vs. 0.2-1.5), PSA nadir after surgery (< 0.5 vs. >= 0.5), positive surgical margins (yes/no). Reference level = placebo arm.||
1766631|NCT00002850|3243719|Superiority or Other|||||||0.218|||||||Fisher Exact|Target accrual=70 patients per arm to provide 92% power to detect a difference of 0.31 vs. 0.08 in the proportion of patients with serious infection.||"H0: There is no significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.~Ha: There is a significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level."|
1766632|NCT00002651|3243726|Superiority or Other||Mean Difference (Net)|1.32||||0.23|2-Sided|95.0|-0.83|3.46||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided||||
1766633|NCT00002651|3243727|Superiority or Other||Mean Difference (Net)|18.0||||0.04|2-Sided|95.0|1.0|36.0||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided||||
1766634|NCT00002651|3243728|Superiority or Other||Mean Difference (Net)|-10.0|||<|0.001|2-Sided|95.0|-14.0|-5.0||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided||||
1766635|NCT00002651|3243729|Superiority or Other||Mean Difference (Net)|2.88||||0.003|2-Sided|95.0|1.0|4.76||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided||||
1766636|NCT00002651|3243730|Superiority or Other||Mean Difference (Net)|1.83||||0.09|2-Sided|95.0|-0.31|3.97||The type I error rate used was 0.005 in an attempt to adjust for multiple primary scores being tested.The type II error rate used was 0.10 (power = 0.9).|t-test, 2 sided||||
1766637|NCT00002651|3243731|Non-Inferiority or Equivalence|The overall type I error rate used is 0.05. The type II error rate is 0.10 (power = 0.9). The trial planned for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. A hazard ratio of 1.0 was used as the specific alternative in the trial size computations. Thus, rejection of the hypothesis will be evidence against the possibility that the intermittent CAD hazard ratio is larger than the continuous CAD hazard ratio by 20% or more.|Hazard Ratio (HR)|1.1||||0.15|2-Sided|90.0|0.99|1.23|||Regression, Cox||||
1766638|NCT00051558|3243745|Superiority or Other|||||||0.256||||||p-value for Nonvertebral Fragility Fracture|Cochran-Mantel-Haenszel||||
1766639|NCT00051558|3243745|Superiority or Other|||||||0.037||||||p-value for Clinical Vertebral Fracture|Cochran-Mantel-Haenszel||||
1766640|NCT00051558|3243745|Superiority or Other|||||||0.007||||||p-value for Vertebral Fracture|Cochran-Mantel-Haenszel||||
1766641|NCT00051558|3243745|Superiority or Other|||||||0.843||||||p-value for Nonvertebral Fracture|Cochran-Mantel-Haenszel||||
1766642|NCT00051558|3243745|Superiority or Other|||||||0.212||||||p-value for Any Fracture|Cochran-Mantel-Haenszel||||
1766643|NCT00051558|3243746|Superiority or Other||||||<|0.001||||||P-value at Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766644|NCT00051558|3243746|Superiority or Other||||||<|0.001||||||P-value at Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766645|NCT00051558|3243746|Superiority or Other||||||<|0.001||||||P-value at Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766646|NCT00051558|3243746|Superiority or Other||||||<|0.001||||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766647|NCT00051558|3243747|Superiority or Other||||||<|0.001||||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766648|NCT00051558|3243747|Superiority or Other||||||<|0.001||||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766649|NCT00051558|3243747|Superiority or Other||||||<|0.001||||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766650|NCT00051558|3243747|Superiority or Other||||||<|0.001||||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766651|NCT00051558|3243748|Superiority or Other||||||<|0.001||||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766652|NCT00051558|3243748|Superiority or Other||||||<|0.001||||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766653|NCT00051558|3243748|Superiority or Other||||||<|0.001||||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766654|NCT00051558|3243748|Superiority or Other||||||<|0.001||||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766655|NCT00051558|3243749|Superiority or Other|||||||0.013||||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766656|NCT00051558|3243749|Superiority or Other|||||||0.004||||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766657|NCT00051558|3243749|Superiority or Other||||||<|0.001||||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766658|NCT00051558|3243749|Superiority or Other||||||<|0.001||||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766659|NCT00051558|3243750|Superiority or Other||||||<|0.001||||||P-value for Month 36|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766660|NCT00051558|3243750|Superiority or Other||||||<|0.001||||||P-value for Month 18|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766661|NCT00051558|3243750|Superiority or Other||||||<|0.001||||||P-value for Month 6|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766662|NCT00051558|3243750|Superiority or Other||||||<|0.001||||||P-value for Month 1|Wilcoxon (Mann-Whitney)|Wilcoxon Rank Sum Test using the aligned ranks for scores.|||
1766663|NCT00051558|3243751|Superiority or Other||||||<|0.001||||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766664|NCT00051558|3243751|Superiority or Other||||||<|0.001||||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766665|NCT00051558|3243751|Superiority or Other||||||<|0.009||||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766666|NCT00051558|3243751|Superiority or Other||||||<|0.011||||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766667|NCT00051558|3243752|Superiority or Other||||||<|0.001||||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766668|NCT00051558|3243752|Superiority or Other||||||<|0.002||||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766669|NCT00051558|3243752|Superiority or Other||||||<|0.015||||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766670|NCT00051558|3243752|Superiority or Other||||||<|0.001||||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766671|NCT00051558|3243753|Superiority or Other|||||||0.009||||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766672|NCT00051558|3243753|Superiority or Other|||||||0.006||||||P-value for 18 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.|
1766673|NCT00051558|3243753|Superiority or Other||||||<|0.001||||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766674|NCT00051558|3243753|Superiority or Other||||||<|0.001||||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766675|NCT00051558|3243753|Superiority or Other||||||<|0.001||||||P-value for 36 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline total hip bone mineral density (BMD) measurement.|
1766676|NCT00051558|3243754|Superiority or Other|||||||0.015||||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766677|NCT00051558|3243754|Superiority or Other|||||||0.011||||||P-value for 18 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.|
1766678|NCT00051558|3243754|Superiority or Other|||||||0.002||||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766679|NCT00051558|3243754|Superiority or Other||||||<|0.001||||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766680|NCT00051558|3243754|Superiority or Other||||||<|0.001||||||P-value for 36-month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline femoral neck bone mineral density (BMD) measurement.|
1766681|NCT00051558|3243755|Superiority or Other||||||<|0.001||||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766862|NCT00048542|3244084|Superiority or Other|||||||0.028|||||||Pearson's Chi-square test||||
1766682|NCT00051558|3243755|Superiority or Other||||||<|0.001||||||p-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766683|NCT00051558|3243755|Superiority or Other||||||<|0.001||||||p-value for 36 month endpoint|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.|
1766684|NCT00051558|3243756|Superiority or Other||||||<|0.001||||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766685|NCT00051558|3243756|Superiority or Other||||||<|0.001||||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766686|NCT00051558|3243756|Superiority or Other||||||<|0.001||||||P-value for 6 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766687|NCT00051558|3243756|Superiority or Other||||||<|0.12||||||P-value for 3 Months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766688|NCT00051558|3243757|Superiority or Other||||||<|0.001||||||P-value for 36 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766689|NCT00051558|3243757|Superiority or Other||||||<|0.001||||||P-value for 24 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766690|NCT00051558|3243757|Superiority or Other||||||<|0.001||||||P-value for 18 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766691|NCT00051558|3243757|Superiority or Other||||||<|0.001||||||P-value for 12 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766692|NCT00051558|3243757|Superiority or Other||||||<|0.001||||||P-value for 6 months|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766693|NCT00051558|3243757|Superiority or Other||||||<|0.058||||||P-value for Month 3|Mixed Models Analysis|Least Squares Means obtained from the treatment*visit interaction term from the above mixed model repeated measures model.||Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment*visit.|
1766694|NCT00051558|3243758|Superiority or Other||||||<|0.001||||||All comparisons were conducted using a 2-sided significance level of 0.05.|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.|
1766695|NCT00051558|3243759|Superiority or Other||||||<|0.001||||||All comparisons were conducted using a 2-sided significance level of 0.05.|ANOVA|ANOVA Model: Change in BMD=treatment+region+prior bisphosponate use+gender. Least Squares Means from treatment.||This is a last observation carried forward analysis that included all patients with a baseline and at least one postbaseline lumbar spine bone mineral density (BMD) measurement.|
1766696|NCT00051363|3243763|Superiority or Other|||||||0.001||||||6M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.|
1766697|NCT00051363|3243763|Superiority or Other|||||||0.0106||||||6M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.|
1766698|NCT00051363|3243763|Superiority or Other|||||||0.3796||||||6M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.|
1766699|NCT00051363|3243763|Superiority or Other|||||||0.0005||||||6M- ESS-TS; Comparison of means by visit only; P<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 6M Subjective Sleepiness/Alertness- ESS-TS.|
1766772|NCT00050778|3243782|Superiority or Other|||||||0.3077|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.|
1766863|NCT00048542|3244084|Superiority or Other|||||||0.061|||||||Pearson's Chi-square test||||
1766700|NCT00051363|3243763|Superiority or Other|||||||0.0005||||||2M- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.|
1766701|NCT00051363|3243763|Superiority or Other|||||||0.0236||||||2M- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.|
1766702|NCT00051363|3243763|Superiority or Other|||||||0.3886||||||2M- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.|
1766703|NCT00051363|3243763|Superiority or Other|||||||0.0004||||||2M- ESS-TS; Comparison of means by visit only; P<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for 2M Subjective Sleepiness/Alertness- ESS-TS.|
1766704|NCT00051363|3243763|Superiority or Other|||||||0.9537||||||DX- ESS-TS (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.|
1766705|NCT00051363|3243763|Superiority or Other|||||||0.704||||||DX- ESS-TS (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.|
1766706|NCT00051363|3243763|Superiority or Other|||||||0.6152||||||DX- ESS-TS (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.|
1766707|NCT00051363|3243763|Superiority or Other|||||||0.9291||||||DX- ESS-TS; Comparison of means by visit only; P<0.05 indicates statistical significance for P values.|Regression, Linear|Regression analyses for the ESS used Generalized Linear Models (GLM) for an over-dispersed binomial distribution.||Comparison of means (regression estimates) between arms for DX Subjective Sleepiness/Alertness- ESS-TS.|
1766708|NCT00051363|3243764|Superiority or Other|||||||0.0002||||||6M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.|
1766709|NCT00051363|3243764|Superiority or Other|||||||0.517||||||6M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.|
1766710|NCT00051363|3243764|Superiority or Other|||||||0.763||||||6M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.|
1766711|NCT00051363|3243764|Superiority or Other|||||||0.0022||||||6M- MWT-MSL; Comparison of means by visit only; P<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 6M Objective Sleepiness/Alertness- MWT-MSL.|
1766712|NCT00051363|3243764|Superiority or Other|||||||0.0002||||||2M- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.|
1766713|NCT00051363|3243764|Superiority or Other|||||||0.752||||||2M- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.|
1766714|NCT00051363|3243764|Superiority or Other|||||||0.2476||||||2M- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.|
1766715|NCT00051363|3243764|Superiority or Other|||||||0.0052||||||2M- MWT-MSL; Comparison of means by visit only; P<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for 2M Objective Sleepiness/Alertness- MWT-MSL.|
1766716|NCT00051363|3243764|Superiority or Other|||||||0.5018||||||DX- MWT-MSL (Severe OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.|
1766864|NCT00048542|3244085|Superiority or Other|||||||0.031|||||||Log Rank||||
1766717|NCT00051363|3243764|Superiority or Other|||||||0.8314||||||DX- MWT-MSL (Moderate OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.|
1766718|NCT00051363|3243764|Superiority or Other|||||||0.9778||||||DX- MWT-MSL (Mild OSA); Comparison of means by visit and Obstructive Sleep Apnea (OSA) severity; P<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.|
1766719|NCT00051363|3243764|Superiority or Other|||||||0.654||||||DX- MWT-MSL; Comparison of means by visit only; P<0.05 indicates statistical significance for P values.|Chop-lump Wilcoxon|Chop-lump test was selected due to a high frequency of scores at the twenty-minute ceiling.||Comparison of means (regression estimates) between arms for DX Objective Sleepiness/Alertness- MWT-MSL.|
1766720|NCT00051363|3243765|Superiority or Other|||||||0.8961||||||6M E/F Function- SAT-D-NumRuCh (Severe OSA); P<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (<=2 vs. >=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766721|NCT00051363|3243765|Superiority or Other|||||||0.2771||||||6M E/F Function- SAT-D-NumRuCh (Moderate OSA); P<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (<=2 vs. >=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766722|NCT00051363|3243765|Superiority or Other|||||||0.8391||||||6M E/F Function- SAT-D-NumRuCh (Mild OSA); P<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (<=2 vs. >=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766723|NCT00051363|3243765|Superiority or Other|||||||0.4528||||||2M E/F Function- SAT-D-NumRuCh (Severe OSA); P<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (<=2 vs. >=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766724|NCT00051363|3243765|Superiority or Other|||||||0.4108||||||2M E/F Function- SAT-D-NumRuCh (Moderate OSA); P<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (<=2 vs. >=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766725|NCT00051363|3243765|Superiority or Other|||||||0.9518||||||2M E/F Function- SAT-D-NumRuCh (Mild OSA); P<0.05 indicates statistical significance for P values. Outcome formulated as dichotomized variable (<=2 vs. >=3) based on a 5th percentile cut-off used in pilot studies per test developer suggestion.|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SAT-D-NumRuCh.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766726|NCT00051363|3243766|Superiority or Other|||||||0.5029||||||6M E/F Function- SWMT-ActMD (Severe OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766727|NCT00051363|3243766|Superiority or Other|||||||0.989||||||6M E/F Function- SWMT-ActMD (Moderate OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766728|NCT00051363|3243766|Superiority or Other|||||||0.8197||||||6M E/F Function- SWMT-ActMD (Mild OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766729|NCT00051363|3243766|Superiority or Other|||||||0.6672||||||2M E/F Function- SWMT-ActMD (Severe OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766730|NCT00051363|3243766|Superiority or Other|||||||0.4512||||||2M E/F Function- SWMT-ActMD (Moderate OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766731|NCT00051363|3243766|Superiority or Other|||||||0.045||||||2M E/F Function- SWMT-ActMD (Mild OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-ActMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766732|NCT00051363|3243767|Superiority or Other|||||||0.0739||||||6M E/F Function- SWMT-BehMD (Severe OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766733|NCT00051363|3243767|Superiority or Other|||||||0.1838||||||6M E/F Function- SWMT-BehMD (Moderate OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766734|NCT00051363|3243767|Superiority or Other|||||||0.8703||||||6M E/F Function- SWMT-BehMD (Mild OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766735|NCT00051363|3243767|Superiority or Other|||||||0.0031||||||2M E/F Function- SWMT-BehMD (Severe OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766736|NCT00051363|3243767|Superiority or Other|||||||0.89||||||2M E/F Function- SWMT-BehMD (Moderate OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766737|NCT00051363|3243767|Superiority or Other|||||||0.5419||||||2M E/F Function- SWMT-BehMD (Mild OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M E/F Function- SWMT-BehMD.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ."|
1766738|NCT00051363|3243768|Superiority or Other|||||||0.5235||||||6M L/M Function- BSRTDR-TotRec (Severe OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."|
1766773|NCT00050778|3243783|Superiority or Other|||||||0.0215|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.|
1766774|NCT00050778|3243783|Superiority or Other|||||||0.0195|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.|
1766739|NCT00051363|3243768|Superiority or Other|||||||0.2069||||||6M L/M Function- BSRTDR-TotRec (Moderate OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."|
1766740|NCT00051363|3243768|Superiority or Other|||||||0.2462||||||6M L/M Function- BSRTDR-TotRec (Mild OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."|
1766741|NCT00051363|3243768|Superiority or Other|||||||0.1835||||||2M L/M Function- BSRTDR-TotRec (Severe OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."|
1766742|NCT00051363|3243768|Superiority or Other|||||||0.3161||||||2M L/M Function- BSRTDR-TotRec (Moderate OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."|
1766743|NCT00051363|3243768|Superiority or Other|||||||0.4262||||||2M L/M Function- BSRTDR-TotRec (Mild OSA); P<0.05 indicates statistical significance for P values.|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- BSRTDR-TotRec.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline BSRTDR-TotRec was also included as a covariate."|
1766744|NCT00051363|3243769|Superiority or Other|||||||0.3075||||||"6M A/P Function- PVT-Slo10%RT (Severe OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."|
1766745|NCT00051363|3243769|Superiority or Other|||||||0.9603||||||"6M A/P Function- PVT-Slo10%RT (Moderate OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."|
1766746|NCT00051363|3243769|Superiority or Other|||||||0.7807||||||"6M A/P Function- PVT-Slo10%RT (Mild OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."|
1766747|NCT00051363|3243769|Superiority or Other|||||||0.5288||||||"2M A/P Function- PVT-Slo10%RT (Severe OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."|
1766769|NCT00051363|3243774|Superiority or Other|||||||0.0074||||||"2M E/F Function- SWMT-OMD; P<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).~After correction for multiple comparisons (sequential Bonferroni) P Value=0.0444 (NS)"|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 2M E/F Function- SWMT-OMD.|
1766770|NCT00050778|3243782|Superiority or Other|||||||0.2758|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.|
1766748|NCT00051363|3243769|Superiority or Other|||||||0.6765||||||"2M A/P Function- PVT-Slo10%RT (Moderate OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."|
1766749|NCT00051363|3243769|Superiority or Other|||||||0.9656||||||"2M A/P Function- PVT-Slo10%RT (Mild OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-Slo10%RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."|
1766750|NCT00051363|3243770|Superiority or Other|||||||0.4372||||||"6M A/P Function- PVT-MedRT (Severe OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."|
1766751|NCT00051363|3243770|Superiority or Other|||||||0.9464||||||"6M A/P Function- PVT-MedRT (Moderate OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."|
1766752|NCT00051363|3243770|Superiority or Other|||||||0.3901||||||"6M A/P Function- PVT-MedRT (Mild OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."|
1766753|NCT00051363|3243770|Superiority or Other|||||||0.3426||||||"2M A/P Function- PVT-MedRT (Severe OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."|
1766754|NCT00051363|3243770|Superiority or Other|||||||0.9673||||||"2M A/P Function- PVT-MedRT (Moderate OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."|
1766755|NCT00051363|3243770|Superiority or Other|||||||0.3699||||||"2M A/P Function- PVT-MedRT (Mild OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M A/P Function- PVT-MedRT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. Months since randomization were also included as covariate."|
1766756|NCT00051363|3243771|Superiority or Other|||||||0.3055||||||"6M L/M Function- PN-RT (Moderate OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."|
1766771|NCT00050778|3243782|Superiority or Other|||||||0.3632|||||||ANCOVA|||Ranked ANCOVA model using Baseline MRI-T2 lesion volume, EDSS group, country, and treatment as covariates was used.|
1766757|NCT00051363|3243771|Superiority or Other|||||||0.3973||||||"6M L/M Function- PN-RT (Moderate OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."|
1766758|NCT00051363|3243771|Superiority or Other|||||||0.3972||||||"6M L/M Function- PN-RT (Mild OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 6M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."|
1766759|NCT00051363|3243771|Superiority or Other|||||||0.5667||||||"2M L/M Function- PN-RT (Severe OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."|
1766760|NCT00051363|3243771|Superiority or Other|||||||0.6487||||||"2M L/M Function- PN-RT (Moderate OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."|
1766761|NCT00051363|3243771|Superiority or Other|||||||0.5606||||||"2M L/M Function- PN-RT (Mild OSA); P<0.05 indicates statistical significance for P values.~Data were reciprocal transformed for analysis and back-transformed for reporting."|Mixed Models Analysis|Generalized Linear Mixed Models (GLMM) were utilized to account for repeated measures (DX, 2M, 6M).||"Comparison of means (regression estimates) between arms for covariate adjusted 2M L/M Function- PN-RT.~Covariates were designated in the a priori secondary analysis plan as being the most likely to explain variation in the outcomes. Covariates included: study arm, OSA severity, sex, race, % of total sleep time oxygen saturation < 85% (PSG), age < 60 years, WASI Verbal IQ, and WASI Performance IQ. A pre-randomization baseline PN-RT and months since randomization were also included as covariates."|
1766762|NCT00051363|3243772|Superiority or Other|||||||0.7569||||||6M L/M Function- BSRT-SR; P<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 6M L/M Function- BSRT-SR.|
1766763|NCT00051363|3243772|Superiority or Other|||||||0.5444||||||2M L/M Function- BSRT-SR; P<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 2M L/M Function- BSRT-SR.|
1766764|NCT00051363|3243772|Superiority or Other|||||||0.7936||||||DX L/M Function- BSRT-SR; P<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for DX L/M Function- BSRT-SR.|
1766765|NCT00051363|3243773|Superiority or Other|||||||0.2103||||||6M A/P Function- PFN-TOTL; P<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for 6M A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."|
1766766|NCT00051363|3243773|Superiority or Other|||||||0.086||||||2M A/P Function- PFN-TOTL; P<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for 2M A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."|
1766767|NCT00051363|3243773|Superiority or Other|||||||0.4538||||||DX A/P Function- PFN-TOTL; P<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Parametric survival analysis|Parametric survival analyses were conducted using by-visit comparisons for A/P Function- PFN-TOTL since these data were right censored at 60.||"Comparison of means (regression estimates) between arms for DX A/P Function- PFN-TOTL.~Data were reciprocal transformed for analysis and back-transformed for reporting."|
1766768|NCT00051363|3243774|Superiority or Other|||||||0.2254||||||6M E/F Function- SWMT-OMD; P<0.0307 indicates statistical significance for raw P values (after adjustment for O'Brien-Fleming spending across 3 interim analyses).|Regression, Linear|Generalized Linear Models (GLM) were run by visit (2M and 6M).||Comparison of means (regression estimates) between arms for 6M E/F Function- SWMT-OMD.|
1766775|NCT00050778|3243783|Superiority or Other|||||||0.0885|||||||ANCOVA|||Ranked analysis of covariance (ANCOVA) model using Baseline MRI-T1 brain volume, EDSS group, country, and treatment as covariates was used.|
1766776|NCT00050778|3243784|Superiority or Other||Treatment effect|70.13|||<|0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.|
1766777|NCT00050778|3243784|Superiority or Other||Treatment effect|76.71|||<|0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.|
1766778|NCT00050778|3243784|Superiority or Other||Treatment effect|62.64|||<|0.0001|||||||Cox Proportional Hazards Regression|||Cox PH regression model with treatment group indicator, Baseline EDSS and country as covariates was used.|
1766779|NCT00050778|3243785|Superiority or Other||Rate ratio|0.28|||<|0.0001|2-Sided|95.0|0.176|0.441|||Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).|
1766780|NCT00050778|3243785|Superiority or Other||Rate ratio|0.23|||<|0.0001|2-Sided|95.0|0.126|0.431||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0040.|Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).|
1766781|NCT00050778|3243785|Superiority or Other||Rate ratio|0.33|||<|0.0001|2-Sided|95.0|0.196|0.552||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0040.|Andersen-Gill Model|||Treatment effects were estimated using an Anderson-Gill multiplicative intensity model with robust variance estimation. Covariates included treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country).|
1766782|NCT00050778|3243786|Superiority or Other||Hazard Ratio (HR)|0.28|||<|0.0001|2-Sided|95.0|0.152|0.515|||Cox Proportional Hazards Regression|||Cox PH regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.|
1766783|NCT00050778|3243786|Superiority or Other||Hazard Ratio (HR)|0.31|||<|0.0021|2-Sided|95.0|0.151|0.658||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0165.|Cox Proportional Hazards Regression|||Cox PH regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.|
1766784|NCT00050778|3243786|Superiority or Other||Hazard Ratio (HR)|0.24|||<|0.0006|2-Sided|95.0|0.11|0.545||An alpha-sharing approach was used to adjust for multiple treatment group comparisons, endpoints, and two pre-planned interim analyses, including a Lan-Demets error-spending function. Pre-specified threshold for statistical significance was 0.0165.|Cox Proportional Hazards Regression|||Cox proportional hazards (PH) regression model using treatment group, Baseline EDSS group (grouped by less than or equal to 1.5 and greater than 1.5), and country (investigative center grouped by country) as covariates was used.|
1766785|NCT00050089|3243793|Superiority or Other||Hazard Ratio (HR)|1.08||||0.68|2-Sided|95.0|0.8|1.46|||Log Rank||The comparison was ARDFP (interruption) vs No ARDFP (continuation) of ART|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison.|
1766786|NCT00050089|3243794|Superiority or Other||Hazard Ratio (HR)|1.008||||0.92|2-Sided|95.0|0.75|1.35|||Log Rank||The comparison was Standard-ART (standard) vs Mega-ART (intensification)|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison|
1766787|NCT00050089|3243795|Superiority or Other|||||||0.87|||||||Log Rank|||Stratified Log-rank test was used to compare the four treatment|
1766788|NCT00050089|3243796|Superiority or Other||Hazard Ratio (HR)|0.927||||0.49|2-Sided|95.0|0.674|1.275|||Log Rank||The comparison was ARDFP (interruption) vs No ARDFP (continuation)|Time-to-event (Kaplan-Meier) and stratified log-rank analysis was performed.|
1766789|NCT00050089|3243797|Superiority or Other||Hazard Ratio (HR)|1.165||||0.69|2-Sided|95.0|0.856|1.585|||Log Rank||The comparison was Mega-ART (intensification) vs Standard-ART (standard).|Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison.|
1766790|NCT00048581|3243883|Superiority or Other||Adj M Chg from BL: Activities|-0.4|||<|0.001|2-Sided|95.0|-0.58|-0.22|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL|
1766791|NCT00048581|3243883|Superiority or Other||Adj M Chg from BL: Gripping|-0.32|||<|0.001|2-Sided|95.0|-0.49|-0.15|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL|
1766792|NCT00048581|3243883|Superiority or Other||Adj M Chg from BL: Reaching|-0.43|||<|0.001|2-Sided|95.0|-0.61|-0.25|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL|
1766865|NCT00048542|3244086|Superiority or Other|||||||0.029|||||||Log Rank||||
1766793|NCT00048581|3243883|Superiority or Other||Adj M Chg from BL: Hygiene|-0.22|||<|0.01|2-Sided|95.0|-0.39|-0.05|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL|
1766794|NCT00048581|3243883|Superiority or Other||Adj M Chg from BL: Walking|-0.26|||<|0.003|2-Sided|95.0|-0.44|-0.09|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg from BL|
1766795|NCT00048581|3243883|Superiority or Other||Adj M Chg from BL: Eating|-0.48|||<|0.001|2-Sided|95.0|-0.65|-0.3|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL|
1766796|NCT00048581|3243883|Superiority or Other||Adj M Chg from BL: Arising|-0.32|||<|0.001|2-Sided|95.0|-0.47|-0.16|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL|
1766797|NCT00048581|3243883|Superiority or Other||Adj M Chg from BL: Dressing and Grooming|-0.32|||<|0.001|2-Sided|95.0|-0.49|-0.14|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline= Adj M Chg From BL|
1766798|NCT00048581|3243883|Superiority or Other||Adj M Chg from BL: HAQ-DI|-0.34|||<|0.001|2-Sided|95.0|-0.44|-0.23|||ANCOVA|||Mean changes from baseline in HAQ disability index were compared between treatment groups using analysis of covariance (ANCOVA) models and 95% confidence intervals were calculated. This analysis was based on the LOCF data set. Similar analyses were also conducted for each of the 8 individual categories: 1) dressing and grooming; 2) arising; 3) eating; 4) walking; 5) hygiene; 6) reach; 7) grip; and 8) common daily activities. Adjusted Mean Change From Baseline = Adj M Chg From BL|
1766799|NCT00048581|3243885|Superiority or Other||Adj Diff: Mental Health|2.7||||0.006|2-Sided|95.0|0.79|4.6|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766800|NCT00048581|3243885|Superiority or Other||Adj Diff: Day 169 Role Emotional|3.54||||0.013|2-Sided|95.0|0.74|6.33|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766801|NCT00048581|3243885|Superiority or Other||Adj Diff: Day 169 Social Functioning|4.92|||<|0.001|2-Sided|95.0|2.71|7.12|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766802|NCT00048581|3243885|Superiority or Other||Adj Diff: Day 169 Vitality|4.78|||<|0.001|2-Sided|95.0|2.76|6.79|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766803|NCT00048581|3243885|Superiority or Other||Adj Diff: Day 169 General Health|3.27|||<|0.001|2-Sided|95.0|1.64|4.9|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766804|NCT00048581|3243885|Superiority or Other||Adj Diff: Day 169 Bodily Pain|6.24|||<|0.001|2-Sided|95.0|4.37|8.11|||ANCOVA||||
1766805|NCT00048581|3243885|Superiority or Other||Adj Diff: Day 169 Role-Physical|5.22|||<|0.001|2-Sided|95.0|3.1|7.35|||ANCOVA||||
1766806|NCT00048581|3243885|Superiority or Other||Adj Diff: Day 169 Physical Function|4.03|||<|0.001|2-Sided|95.0|2.08|5.98|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766807|NCT00048581|3243885|Superiority or Other||Adj Diff: Day 169 MCS|3.04|||<|0.005|2-Sided|95.0|0.91|5.17|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766808|NCT00048581|3243885|Superiority or Other||Adj Diff: Day 169 PCS|5.46|||<|0.001|2-Sided|95.0|3.64|7.29|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766809|NCT00048581|3243887|Superiority or Other||Adj Diff: Day 85 Mental Health|2.59||||0.009|2-Sided|95.0|0.65|4.54|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766810|NCT00048581|3243887|Superiority or Other||Adj Diff: Day 85 Role Emotional|0.97||||0.494|2-Sided|95.0|-1.82|3.77|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766811|NCT00048581|3243887|Superiority or Other||Adj Diff: Day 85 Social Functioning|4.69|||<|0.001|2-Sided|95.0|2.59|6.79|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766812|NCT00048581|3243887|Superiority or Other||Adj Diff: Day 85 Vitality|3.17|||<|0.001|2-Sided|95.0|1.24|5.1|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766813|NCT00048581|3243887|Superiority or Other||Adj Diff: General Health|2.51|||<|0.001|2-Sided|95.0|0.99|4.02|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766814|NCT00048581|3243887|Superiority or Other||Adj Diff: Day 85 Bodily Pain|5.62|||<|0.001|2-Sided|95.0|3.77|7.47|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766815|NCT00048581|3243887|Superiority or Other||Adj Diff: Day 85 Role-Physical|3.01|||<|0.007|2-Sided|95.0|0.83|5.19|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766816|NCT00048581|3243887|Superiority or Other||Adj Diff: Day 85 Physical Function|1.7|||<|0.052|2-Sided|95.0|-0.01|3.41|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766817|NCT00048581|3243887|Superiority or Other||Adj Diff: Day 85 MCS|2.57|||<|0.017|2-Sided|95.0|0.47|4.67|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766818|NCT00048581|3243887|Superiority or Other||Adj Diff: Day 85 PCS|3.63|||<|0.001|2-Sided|95.0|1.89|5.38|||ANCOVA|||Differences in mean changes from baseline between the 2 treatment groups (ABA and PLA) in PCS, MCS, and the 8 subscale scores at Day 85 were compared using ANCOVA models. Adjusted difference (Adj Diff) from PLA group with 95% CIs and p-values were calculated, and adjustment was based on ANCOVA model with treatment group as factor and baseline value as covariate.|
1766819|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 169 ACR 70|8.7||||0.003|2-Sided|95.0|2.7|14.6|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766820|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 169 ACR 50|16.6|||<|0.001|2-Sided|95.0|8.6|24.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766866|NCT00048542|3244087|Superiority or Other|||||||0.015|||||||Chi-square test||||
1766868|NCT00048165|3244100|Superiority or Other|||||||0.0008|||||||Cochran-Mantel-Haenszel|||Comparison of Daclizumab and Placebo for 12 months were presented|
1766821|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 169 ACR 20|30.8|||<|0.001|2-Sided|95.0|20.0|41.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).|
1766822|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 141 ACR 70|10.2|||<|0.001|2-Sided|95.0|4.4|16.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766823|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 141 ACR 50|20.9|||<|0.001|2-Sided|95.0|12.2|29.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766824|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 141 ACR 20|35.5|||<|0.001|2-Sided|95.0|24.6|46.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).|
1766825|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 113 ACR 70|7.8|||<|0.002|2-Sided|95.0|2.6|13.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766826|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 113 ACR 50|14.2|||<|0.001|2-Sided|95.0|6.6|21.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766827|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 113 ACR 20|25.9|||<|0.001|2-Sided|95.0|15.1|36.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).|
1766828|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 85 ACR 70|5.1|||<|0.033|2-Sided|95.0|0.4|9.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766829|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 85 ACR 50|12.0|||<|0.002|2-Sided|95.0|4.1|19.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766867|NCT00048542|3244089|Superiority or Other|||||||0.031|||||||Chi-square test|||The study was sized to detect a difference in the proportion of subjects (40%) between placebo and the active adalimumab dose group who would experience disease flare assuming a placebo rate of 70% vs. a rate of 30% in the active group. Assuming a binomial distribution, an alpha of 0.05, 80% power, two-sided test, and an initial monotherapy responder rate of 70%, a minimum of 29 subjects were needed per treatment group within the appropriate strata.|
1766830|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 85 ACR 20|28.0|||<|0.001|2-Sided|95.0|17.4|38.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).|
1766831|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 57 ACR 70|5.1|||<|0.019|2-Sided|95.0|0.7|9.4|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766832|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 57 ACR 50|6.5|||<|0.076|2-Sided|95.0|-0.6|13.7|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766833|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 57 ACR 20|22.0|||<|0.001|2-Sided|95.0|11.3|32.8|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).|
1766834|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 29 ACR 70|1.6|||<|0.473|2-Sided|95.0|-1.8|4.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766835|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 29 ACR 50|5.6|||<|0.06|2-Sided|95.0|-0.2|11.4|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766836|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 29 ACR 20|14.0|||<|0.005|2-Sided|95.0|4.0|24.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).|
1766837|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 15 ACR 70|0.8|||<|0.784|2-Sided|95.0|-1.3|2.9|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 70 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 70 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766838|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 15 ACR 50|2.3|||<|0.001|2-Sided|95.0|-0.8|5.5|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||If ACR20 comparison was significant (5% level), then CMH Chi-square test compared ACR 50 response between groups (5% level). If the ACR20 analysis was not significant (5% level), then the comparison for ACR 50 response was not undertaken. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766839|NCT00048581|3243908|Superiority or Other||Est. of Diff: Day 15 ACR 20|12.3|||<|0.001|2-Sided|95.0|4.6|20.0|||Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of difference (Est of Diff)||Differences in ACR 20 between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs were compared using a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test (.05 level of significance), with stratification based on baseline history of anti-TNF status (current or prior use).|
1766857|NCT00048724|3244067|Superiority or Other||Hazard Ratio (HR)|1.452||||0.1439||95.0|0.88|2.396|||Cox Proportional Hazards Model|Age (<= 50 years, >50 years) and participation in a prior study (yes, no) were stratification factors.|Hazard ratio represents results of untreated control relative to treatment.|The primary scientific hypothesis is that, 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of clinical events in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.|
1766840|NCT00048581|3243909|Superiority or Other||Est. of Weighted Diff: Day 169 HAQ|24.0|||<|0.001|2-Sided|95.0|13.8|34.2||If the ACR20 analysis was not significant (5% level), then the comparison for HAQ response was not undertaken. If ACR20 comparison was significant (5% level), then CMH Chi-square test compared HAQ response between groups (5% level).|Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|All comparisons of changes from baseline and construction of confidence intervals for continuous measures were based on an ANCOVA model with treatment as the main factor and baseline value as covariate.|The two primary efficacy analyses tested first for differences in ACR 20 followed by testing HAQ response rates between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving PLA plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766841|NCT00048581|3243910|Superiority or Other||Est. Weighted. Diff: Day 169 ACR 20|30.8|||<|0.001|2-Sided|95.0|20.6|41.1||The a priori threshold for statistical significance was 5%. ACR 20 RR at 6 mos for PLA was expected to be ~25%. A sample of 256 in the ABA arm and 128 in PLA arm will yield a 96% power to detect a difference of 20% in ACR 20 at 5% significance level.|Cochran-Mantel-Haenszel|All statistical tests and CI were 2-sided. Percentage of participants with response compared by estimate of weighted difference (Est of Weighted Diff)|Differences in ACR response between the two treatment groups represent the weighted average of the individual stratum differences.|The first coprimary endpoint efficacy analysis tested for differences in ACR 20 response rate (RR) between the treatment arm receiving ABA plus background DMARDs and the treatment arm receiving placebo plus background DMARDs on Day 169. A 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test was used to compare these two treatment groups at the .05 level of significance, with stratification based on baseline history of anti-TNF status (current or prior use).|
1766842|NCT00048568|3244036|Superiority or Other||Estimated Difference|5.7||||0.002|2-Sided|95.0|2.4|9.0|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving extended MCR.||
1766843|NCT00048568|3244037|Superiority or Other||Adjusted Mean Difference at Day 365|4.15|||<|0.001|2-Sided|95.0|2.69|5.62|||ANCOVA|||Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|
1766844|NCT00048568|3244037|Superiority or Other||Adjusted Mean Difference at Day 169|4.06|||<|0.001|2-Sided|95.0|2.64|5.57|||ANCOVA|||Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|
1766845|NCT00048568|3244041|Superiority or Other||Estimated Difference on Day 365|-1.39|||<|0.001|2-Sided|95.0|-1.63|-1.16|||ANCOVA||Estimated difference between ABA + MTX and MTX + PLA on Day 365.||
1766846|NCT00048568|3244041|Superiority or Other||Estimated Difference on Day 169|-1.15|||<|0.001|2-Sided|95.0|-1.38|-0.91|||ANCOVA||Estimated difference between ABA + MTX and MTX + PLA on Day 169.||
1766847|NCT00048568|3244042|Superiority or Other||Estimated Difference|12.3|||<|0.001|2-Sided|95.0|7.3|17.2|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving MCR.||
1766848|NCT00048568|3244044|Superiority or Other||Mean Difference (Final Values)|22.7|||<|0.001|2-Sided|95.0|15.6|29.8|||Chi-squared, Corrected||||
1766849|NCT00048568|3244045|Superiority or Other||Estimated Difference|13.3|||<|0.001|2-Sided|95.0|7.0|19.5|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA + MTX and MTX + PLA in the proportion of participants achieving ACR 70 response at Day 169.||
1766850|NCT00048568|3244047|Superiority or Other||Estimated Difference|30.1|||<|0.001|2-Sided|95.0|21.8|38.5|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 365.||
1766851|NCT00048568|3244048|Superiority or Other||Estimated Difference|23.0|||<|0.001|2-Sided|95.0|15.0|31.1|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 50 response at Day 169.||
1766852|NCT00048568|3244050|Superiority or Other||Estimated Difference|33.4|||<|0.001|2-Sided|95.0|25.1|41.7|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response at Day 365.||
1766853|NCT00048568|3244054|Superiority or Other|||||||0.029|||||||Nonparametric ANCOVA|The rank of the change from baseline=dependent variable, treatment=the main factor, rank of baseline value as covariate.|||
1766854|NCT00048568|3244055|Superiority or Other||Estimated Difference|24.4|||<|0.001|2-Sided|95.0|15.9|32.9||Based on the hierarchical testing procedure for the co-primary measures, the study had 98% power to detect 18% difference in HAQ response rate between the two arms at the 5% level.|Chi-squared, Corrected|This model includes treatment as the main factor and baseline value as a covariate.|Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving HAQ response at Day 365.||
1766855|NCT00048568|3244056|Superiority or Other||Estimated Difference|28.2|||<|0.001|2-Sided|95.0|19.8|36.7|||Chi-squared, Corrected||Estimated difference between ABA + MTX and MTX + PLA is the estimated difference between ABA+MTX and MTX + PLA in the proportion of participants achieving ACR 20 response.|The study had a 99% power to detect a difference of 20% in ACR 20 between the 2 groups at the 5% level.|
1766856|NCT00048724|3244066|Superiority or Other||Hazard Ratio (HR)|1.564||||0.007||95.0|1.13|2.166|||Cox Proportional Hazards Model|Age (<= 50 years, >50 years) and participation in a prior study (yes, no) were stratification factors.|Hazard ratio represents results of untreated control relative to treatment.|The secondary hypothesis is that 0.5 ug/kg subcutaneous once weekly PegIntron as maintenance therapy is efficacious, when compared to no treatment, in the prevention of disease progression in adult subjects with compensated cirrhosis (Metavir F4), secondary to Chronic Hepatitis C, who have failed to respond to therapy with any α interferon plus ribavirin.|
1766858|NCT00048542|3244082|Superiority or Other|||||||0.002|||||||Pearson's Chi-square test||||
1766859|NCT00048542|3244082|Superiority or Other|||||||0.156|||||||Pearson's Chi-square test||||
1766869|NCT00048165|3244100|Superiority or Other|||||||0.0005|||||||Cochran-Mantel-Haenszel|||Comparison of Daclizumab and Placebo for 6 months were presented|
1766870|NCT00048165|3244103|Superiority or Other||percent mean difference|-8.6||||0.063|2-Sided|95.0|-17.7|0.5|||Cochran-Mantel-Haenszel||||
1766871|NCT00048165|3244104|Superiority or Other||percent mean difference|-12.0||||0.007|2-Sided|95.0|-20.9|-3.3|||Cochran-Mantel-Haenszel||||
1766872|NCT00048074|3244120|Non-Inferiority or Equivalence|The IV dosing regimen (3mg q 3 mo IV) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to –1 percentage point.|Mean Difference (Final Values)|1.025|||<|0.001|2-Sided|95.0|0.471|1.578|||ANOVA||Treatment effect is the difference in the mean values of the IV regimen (3mg q 3 mo IV) and the active-control.|The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (3mg q 3 mo IV) on the relative change in lumbar spine BMD (L2 – L4) was small, no more than 1%, the margin of clinical equivalence.|
1766873|NCT00048074|3244120|Non-Inferiority or Equivalence|The IV dosing regimen (2mg q 2 mo IV) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to –1 percentage point.|Mean Difference (Final Values)|1.257|||<|0.001|2-Sided|95.0|0.701|1.814|||ANOVA||Treatment effect is the difference in the mean values of the IV regimen (2mg q 2 mo IV) and the active-control.|The primary hypothesis was that the difference in the effects of daily oral ibandronate and IV ibandronate (2mg q 2 mo IV) on the relative change in lumbar spine BMD (L2 – L4) was small, no more than 1%, the margin of clinical equivalence.|
1766874|NCT00048061|3244136|Non-Inferiority or Equivalence|The monthly dosing regimen (Ibandronate 150 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to –1 percentage point.|Mean Difference (Final Values)|1.0||||0.001|2-Sided|95.0|0.395|1.605|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 150 mg) and the active-control.||
1766875|NCT00048061|3244136|Non-Inferiority or Equivalence|The monthly dosing regimen (Ibandronate 100 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to –1 percentage point.|Mean Difference (Final Values)|0.297||||0.338|2-Sided|95.0|-0.312|0.906|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 100 mg) and the active-control||
1766876|NCT00048061|3244136|Non-Inferiority or Equivalence|The monthly dosing regimen (Ibandronate 50/50 mg monthly) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to –1 percentage point.|Mean Difference (Final Values)|0.615||||0.045|2-Sided|95.0|0.013|1.216|||ANOVA||Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 50/50) and the active-control.||
1766877|NCT00048048|3244143|Superiority or Other||Least square mean|0.932|Standard Error of the Mean|0.222|||2-Sided|95.0|0.488|1.377|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X /3 Week|
1766878|NCT00048048|3244143|Superiority or Other||Least square mean|0.851|Standard Error of the Mean|0.228|||2-Sided|95.0|0.395|1.307|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X/ 2Week|
1766879|NCT00048048|3244143|Superiority or Other||Least square mean|0.979|Standard Error of the Mean|0.223|||2-Sided|95.0|0.534|1.425|||||To analyze the appropriateness of the chosen conversion factors, a second regression analysis was carried out. This regression was on the three conversion factor dose groups, using the regression slope estimates of Hb. This was not pre-specified.|All cohorts with dosing frequency 1X/ Week|
1766880|NCT00048035|3244149|Superiority or Other||Estimated Conversion Factor 90% CI|0.61|||||2-Sided|90.0|0.53|0.76|||||To analyze the appropriateness of the chosen dose conversion factors, a second regression analysis was carried out. This was a regression on the three different conversion factor dose groups, using the regression slope estimates of Hb change.|All cohorts with dosing frequency 1 X /2 Week|
1766881|NCT00048035|3244149|Superiority or Other||Estimated Conversion Factor 90% CI|0.38|||||2-Sided|90.0|0.32|0.42|||||To analyze the appropriateness of the chosen dose conversion factors, a second regression analysis was carried out. This was a regression on the three different conversion factor dose groups, using the regression slope estimates of Hb.|All cohorts with dosing frequency 1 X / Week|
1766882|NCT00047463|3244160|Superiority or Other|||||||0.26|||||||Wilcoxon (Mann-Whitney)|||The null hypothesis was that the groups would be similar in tolerance. This was a pilot study so we did not do a power calculation.|
1766883|NCT00046475|3244161|Superiority or Other (legacy)|||||||0.007||||||The p-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and subject-within sequence as random effect.|ANOVA|||Analysis of US participants with marked or severe disease severity|
1766884|NCT00046475|3244162|Superiority or Other (legacy)|||||||0.37||||||The p-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and subject-within sequence as random effect.|ANOVA|||Analysis of US participants with mild or moderate disease severity|
1766885|NCT00046475|3244166|Superiority or Other (legacy)|||||||0.578||||||The P-value is based on an ANOVA model with SF-36 physical functioning score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of physical functioning|
1766886|NCT00046475|3244166|Superiority or Other (legacy)|||||||0.569||||||The P-value is based on an ANOVA model with SF-36 general health score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of general health|
1766916|NCT00046228|3244184|Superiority or Other|||||||0.062|||||||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of ICH.|
1766887|NCT00046475|3244167|Superiority or Other (legacy)|||||||0.002||||||The P-value is based on an ANOVA model with change from baseline supine diastolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of supine diastolic blood pressure|
1766888|NCT00046475|3244167|Superiority or Other (legacy)||||||<|0.001||||||The P-value is based on an ANOVA model with change from baseline supine systolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of supine systolic blood pressure|
1766889|NCT00046475|3244168|Superiority or Other (legacy)|||||||0.01||||||The P-value is based on an ANOVA model with change from baseline standing diastolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of standing diastolic blood pressure|
1766890|NCT00046475|3244168|Superiority or Other (legacy)|||||||0.002||||||The P-value is based on an ANOVA model with change from baseline standing systolic blood pressure as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of standing systolic blood pressure|
1766891|NCT00046475|3244171|Superiority or Other (legacy)||||||<|0.001||||||The P-value is based on an ANOVA model with post-treatment global daily activity score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA||||
1766892|NCT00046475|3244172|Superiority or Other (legacy)|||||||0.001||||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 4 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 4|
1766893|NCT00046475|3244172|Superiority or Other (legacy)||||||<|0.001||||||P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 3 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 3|
1766894|NCT00046475|3244172|Superiority or Other (legacy)||||||<|0.001||||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 2 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 2|
1766895|NCT00046475|3244172|Superiority or Other (legacy)||||||<|0.001||||||The P-value is based on an ANOVA model with post-treatment responses for OHDAS Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 1|
1766896|NCT00046475|3244173|Superiority or Other (legacy)|||||||0.002||||||The P-value is based on an ANOVA model with post-treatment composite symptom score as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA||||
1766897|NCT00046475|3244174|Superiority or Other (legacy)|||||||0.226||||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 6 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 6|
1766898|NCT00046475|3244174|Superiority or Other (legacy)|||||||0.026||||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 5 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 5|
1766899|NCT00046475|3244174|Superiority or Other (legacy)|||||||0.004||||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 4 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 4|
1766900|NCT00046475|3244174|Superiority or Other (legacy)|||||||0.002||||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 3 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 3|
1766901|NCT00046475|3244174|Superiority or Other (legacy)||||||<|0.001||||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 2 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA|||Analysis of Item 2|
1766902|NCT00046475|3244175|Superiority or Other (legacy)|||||||0.011||||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA||||
1766903|NCT00046475|3244176|Superiority or Other (legacy)||||||<|0.001||||||The P-value is based on an ANOVA model with post-treatment responses for OHSA Item 1 as dependent variable, treatment, sequence, period (Visit 5 or 6), as fixed effects, and patient within sequence as random effect.|ANOVA||||
1766904|NCT00046228|3244180|Superiority or Other||Odds Ratio (OR)|0.97||||0.809||95.0|0.74|1.27|||Chi-squared||||
1766905|NCT00046228|3244180|Superiority or Other||Odds Ratio (OR)|0.93||||0.589||95.0|0.71|1.22|||Chi-squared||||
1766906|NCT00046228|3244180|Superiority or Other||Odds Ratio (OR)|0.9||||0.434||95.0|0.69|1.18|||Chi-squared||||
1766907|NCT00046228|3244181|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1766908|NCT00046228|3244181|Superiority or Other||||||<|0.02|||||||Fisher Exact||||
1766909|NCT00046228|3244181|Superiority or Other||||||<|0.001|||||||Fisher Exact||||
1766910|NCT00046228|3244182|Superiority or Other|||||||1|||||||Fisher Exact||||
1766911|NCT00046228|3244182|Superiority or Other|||||||0.438|||||||Fisher Exact||||
1766912|NCT00046228|3244182|Superiority or Other|||||||0.439|||||||Fisher Exact||||
1766913|NCT00046228|3244183|Superiority or Other||Odds Ratio (OR)|1.52||||0.008||95.0|1.12|2.05|||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in the risk of non-ICH TIMI bleeding events.|
1766914|NCT00046228|3244183|Superiority or Other||Odds Ratio (OR)|1.51||||0.025||95.0|1.05|2.15|||Fisher Exact|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.|
1766915|NCT00046228|3244183|Superiority or Other||Odds Ratio (OR)|2.28|||<|0.001||95.0|1.63|3.19|||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of non-ICH TIMI bleeding events.|
1766917|NCT00046228|3244184|Superiority or Other|||||||0.497|||||||Fisher Exact|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.|
1766918|NCT00046228|3244184|Superiority or Other|||||||0.218|||||||Fisher Exact|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in the risk of ICH.|
1766919|NCT00046228|3244185|Superiority or Other||Hazard Ratio (HR)|0.86||||0.415||95.0|0.59|1.24|||Log Rank||||
1766920|NCT00046228|3244185|Superiority or Other||Hazard Ratio (HR)|1.06||||0.765||95.0|0.73|1.52|||Log Rank||||
1766921|NCT00046228|3244185|Superiority or Other||Hazard Ratio (HR)|0.9||||0.603||95.0|0.62|1.32|||Log Rank||||
1766922|NCT00046228|3244186|Superiority or Other||Odds Ratio (OR)|1.4||||0.042||95.0|1.01|1.93|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in ST-segment resolution >70% from baseline.|
1766923|NCT00046228|3244186|Superiority or Other||Odds Ratio (OR)|1.08||||0.67||95.0|0.76|1.52|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution >70% from baseline.|
1766924|NCT00046228|3244186|Superiority or Other||Odds Ratio (OR)|1.5||||0.016||95.0|1.08|2.1|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in ST-segment resolution >70% from baseline.|
1766925|NCT00046228|3244187|Superiority or Other||Odds Ratio (OR)|0.94||||0.781||95.0|0.61|1.45|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in 90-day all cause mortality.|
1766926|NCT00046228|3244187|Superiority or Other||Odds Ratio (OR)|1.25||||0.338||95.0|0.79|1.95|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.|
1766927|NCT00046228|3244187|Superiority or Other||Odds Ratio (OR)|1.17||||0.494||95.0|0.74|1.84|||Chi-squared|||The null hypothesis is if retaplase/abciximab facilitated PCI is the same as the primary PCI in 90-day all cause mortality.|
1766928|NCT00046228|3244188|Superiority or Other||Odds Ratio (OR)|0.99||||0.944||95.0|0.68|1.43|||Chi-squared|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in complications of MI within 90 days.|
1766929|NCT00046228|3244188|Superiority or Other||Odds Ratio (OR)|0.82||||0.278||95.0|0.58|1.17|||Chi-squared|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.|
1766930|NCT00046228|3244188|Superiority or Other||Odds Ratio (OR)|0.81||||0.247||95.0|0.57|1.16|||Chi-squared|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in complications of MI within 90 days.|
1766931|NCT00046228|3244189|Superiority or Other||Hazard Ratio (HR)|0.94||||0.676||95.0|0.69|1.27|||Log Rank|||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the abciximab facilitated PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI versus the abciximab facilitated PCI group is 2.6% in lower risk, 8.7% in medium risk, and 13.3% in high risk, the power of this comparison (1,000 subjects per group) is 13.5%.|
1766932|NCT00046228|3244189|Superiority or Other||Hazard Ratio (HR)|0.97||||0.858||95.0|0.72|1.31|||Log Rank|||The null hypothesis is if abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the Abciximab facilitated PCI versus the Primary PCI group is 12.7%, in lower risk, 17.9% in medium risk, and 25.0% in high risk, the power of this comparison (1000 subjects per group) is 54.1%|
1766933|NCT00046228|3244189|Superiority or Other||Hazard Ratio (HR)|0.91||||0.551||95.0|0.67|1.23||The null hypothesis was tested at the significance level of 0.049. If it is significant, the significance level of null hypotheses tested in the analyses 2 and 3 will be adjusted according to the modified Hochberg approach.|Log Rank|Independent Clinical Endpoints Committee confirmed components of primary endpoint except for death & resuscitated v fib assessed by the investigator)||The null hypothesis is if reteplase/abciximab facilitated PCI is the same as the primary PCI in terms of the primary efficacy outcome. Assuming the relative risk reduction for the reteplase/abciximab facilitated PCI group versus the Primary PCI group is 15% in lower risk, 25% in medium risk, and 35% in high risk, the power of this comparison (1,000 subjects per group) is 83.4 %.|
1766934|NCT00044044|3244241|Superiority or Other||||||<|0.05|||||||ANCOVA||||
1766935|NCT00044044|3244242|Superiority or Other||||||<|0.05|||||||ANCOVA||||
1766936|NCT00044044|3244243|Superiority or Other||||||<|0.05|||||||ANCOVA||||
1766937|NCT00044044|3244244|Superiority or Other||||||<|0.05|||||||ANCOVA||||
1766938|NCT00044083|3244246|Other|||||||0.12||||||Drug Effect on General Pathology for Patients|t-test, 1 sided||||
1766939|NCT00044083|3244246|Other|||||||0.4||||||Drug Effect on Negative Syndrome for Patients|t-test, 1 sided||||
1766940|NCT00044083|3244246|Other|||||||0.7||||||Drug Effect on Positive Syndrome for Patients|t-test, 1 sided||||
1766941|NCT00044083|3244247|Other|||||||0.469||||||Drug Effect of Met/Met Genotype in left DLPFC|t-test, 1 sided||||
1766942|NCT00044083|3244247|Other|||||||0.718||||||Drug Effect on Val/Met Genotype in left DLPFC|t-test, 1 sided||||
1766943|NCT00044083|3244247|Other|||||||0.041||||||Drug Effect on Val/Val Genotype in left DLPFC|t-test, 1 sided||||
1766944|NCT00044083|3244247|Other|||||||0.189||||||Drug by Genotype Effect in left DLPFC|ANOVA||||
1766945|NCT00044083|3244248|Other|||||||0.167|||||||ANOVA|Main Effect of Genotype across both Placebo and Tolcapone in left DLPFC|||
1766946|NCT00044083|3244248|Other||||||<|0.0001|||||||ANOVA|Main Effect of Genotype across both Placebo and Tolcapone in right DLPFC|||
1766947|NCT00044083|3244249|Other|||||||0.73||||||Drug Effect on Healthy Volunteers in right DLPFC|t-test, 1 sided||||
1766948|NCT00044083|3244249|Other|||||||0.05||||||Drug Effect on Healthy Volunteers in left DLPFC|t-test, 1 sided||||
1766949|NCT00044083|3244250|Other|||||||0.078||||||Effect of Drug on Patients with Schizophrenia in left DLPFC|t-test, 1 sided||||
1766950|NCT00044083|3244250|Other|||||||0.05||||||The Effect of Drug on Patients with Schizophrenia in right DLPFC|t-test, 1 sided||||
1766951|NCT00044083|3244251|Other|||||||0.32||||||Drug Effect across both groups in right DLPFC|ANOVA||||
1767165|NCT00043186|3244294|Superiority or Other||||||<|0.012|||||||Wilcoxon (Mann-Whitney)||||
1766952|NCT00044083|3244251|Other|||||||0.05||||||Drug Effect across both groups in left DLPFC|ANOVA||||
1766953|NCT00044083|3244252|Other|||||||0.014||||||Diagnosis Effect of Placebo in left DLPFC|ANOVA||||
1766954|NCT00044083|3244252|Other||||||<|0.0001||||||Diagnosis Effect on Placebo in right DLPFC|ANOVA||||
1766955|NCT00044083|3244253|Other|||||||0.0034||||||Drug Effect on Patients|ANOVA||||
1766956|NCT00044083|3244253|Other||||||<|0.0001||||||Diagnosis effect on placebo|ANOVA||||
1766957|NCT00043979|3244256|Superiority or Other|||||||0.0003||||||7 participants who did not receive a transplant compared with 21 participants transplanted.|Kaplan-Meier||||
1766958|NCT00043550|3244268|Superiority||Slope|0.06|||||2-Sided|95.0|-0.33|0.45|||||||
1766959|NCT00043550|3244268|Superiority||Slope|0.03|||||2-Sided|95.0|-0.35|0.41|||||||
1766960|NCT00043550|3244268|Superiority||||||<|0.0001|||||||HLM|||effects of conditions over time|
1766961|NCT00043550|3244268|Superiority|The proposed sample size had at least 80% power to detect effect sizes of 0.36 between the two active treatment conditions and placebo during the active phase. These power calculations were based on a priori values of within-subject correlation of 0.50, 10% attrition, and 6 assessment points.|Slope|1.0|||<|0.95|2-Sided|||||Overall significant effect for treatment, as well as the two moderating effects, used a Bonferroni-corrected alpha level of 0.0167 (0.05/3).|HLM|||Comparison of conditions|
1766962|NCT00043186|3244269|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1766963|NCT00043186|3244269|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1766964|NCT00043186|3244269|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1766965|NCT00043186|3244269|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766966|NCT00043186|3244269|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)||||
1766967|NCT00043186|3244269|Superiority or Other||||||<|0.003|||||||Wilcoxon (Mann-Whitney)||||
1766968|NCT00043186|3244269|Superiority or Other||||||<|0.218|||||||Wilcoxon (Mann-Whitney)||||
1766969|NCT00043186|3244269|Superiority or Other||||||<|0.142|||||||Wilcoxon (Mann-Whitney)||||
1766970|NCT00043186|3244270|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1766971|NCT00043186|3244270|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)||||
1766972|NCT00043186|3244270|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)||||
1766973|NCT00043186|3244270|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766974|NCT00043186|3244270|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766975|NCT00043186|3244270|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766976|NCT00043186|3244270|Superiority or Other||||||<|0.058|||||||Wilcoxon (Mann-Whitney)||||
1766977|NCT00043186|3244270|Superiority or Other||||||<|0.061|||||||Wilcoxon (Mann-Whitney)||||
1766978|NCT00043186|3244271|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766979|NCT00043186|3244271|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766980|NCT00043186|3244271|Superiority or Other||||||<|0.146|||||||Wilcoxon (Mann-Whitney)||||
1766981|NCT00043186|3244271|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766982|NCT00043186|3244271|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766983|NCT00043186|3244271|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766984|NCT00043186|3244271|Superiority or Other||||||<|0.008|||||||Wilcoxon (Mann-Whitney)||||
1766985|NCT00043186|3244271|Superiority or Other||||||<|0.049|||||||Wilcoxon (Mann-Whitney)||||
1766986|NCT00043186|3244272|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766987|NCT00043186|3244272|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766988|NCT00043186|3244272|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766989|NCT00043186|3244272|Superiority or Other||||||<|0.002|||||||Wilcoxon (Mann-Whitney)||||
1766990|NCT00043186|3244272|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766991|NCT00043186|3244272|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766992|NCT00043186|3244272|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766993|NCT00043186|3244272|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766994|NCT00043186|3244273|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766995|NCT00043186|3244273|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766996|NCT00043186|3244273|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766997|NCT00043186|3244273|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766998|NCT00043186|3244273|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1766999|NCT00043186|3244273|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767000|NCT00043186|3244273|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767001|NCT00043186|3244273|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767002|NCT00043186|3244274|Superiority or Other||Mean Difference (Final Values)|6.22|||<|0.001||95.0|3.58|8.87|||ANCOVA||||
1767003|NCT00043186|3244274|Superiority or Other||Mean Difference (Final Values)|5.91|||<|0.001||95.0|3.13|8.7|||ANCOVA||||
1767004|NCT00043186|3244274|Superiority or Other||Mean Difference (Final Values)|6.29|||<|0.001||95.0|3.25|9.34|||ANCOVA||||
1767005|NCT00043186|3244274|Superiority or Other||Mean Difference (Final Values)|5.96|||<|0.001||95.0|3.44|8.48|||ANCOVA||||
1767006|NCT00043186|3244274|Superiority or Other||Mean Difference (Final Values)|5.97|||<|0.001||95.0|3.51|8.43|||ANCOVA||||
1767007|NCT00043186|3244274|Superiority or Other||Mean Difference (Final Values)|6.22|||<|0.001||95.0|3.5|8.94|||ANCOVA||||
1767008|NCT00043186|3244274|Superiority or Other||Mean Difference (Final Values)|2.25|||<|0.092||95.0|-0.37|4.87|||ANCOVA||||
1767009|NCT00043186|3244274|Superiority or Other||Mean Difference (Final Values)|7.02|||<|0.001||95.0|4.35|9.69|||ANCOVA||||
1767010|NCT00043186|3244275|Superiority or Other||Mean Difference (Final Values)|0.29||||0.949||95.0|-10.82|11.4|||ANCOVA||||
1767011|NCT00043186|3244275|Superiority or Other||Mean Difference (Final Values)|2.44||||0.949||95.0|-3.77|8.66|||ANCOVA||||
1767012|NCT00043186|3244275|Superiority or Other||Mean Difference (Final Values)|7.23||||0.484||95.0|-0.83|15.3|||ANCOVA||||
1767013|NCT00043186|3244275|Superiority or Other||Mean Difference (Final Values)|2.1||||0.949||95.0|-4.51|8.72|||ANCOVA||||
1767014|NCT00043186|3244275|Superiority or Other||Mean Difference (Final Values)|-2.36||||0.949||95.0|-8.55|3.83|||ANCOVA||||
1767015|NCT00043186|3244275|Superiority or Other||Mean Difference (Final Values)|1.24||||0.709||95.0|-6.81|9.29|||ANCOVA||||
1767016|NCT00043186|3244275|Superiority or Other||Mean Difference (Final Values)|3.3||||0.949||95.0|-2.7|9.31|||ANCOVA||||
1767017|NCT00043186|3244275|Superiority or Other||Mean Difference (Final Values)|2.18||||0.949||95.0|-8.73|13.1|||ANCOVA||||
1767018|NCT00043186|3244276|Superiority or Other||Mean Difference (Final Values)|4.75||||0.001||95.0|2.28|7.22|||ANCOVA||||
1767019|NCT00043186|3244276|Superiority or Other||Mean Difference (Final Values)|4.65||||0.003||95.0|2.05|7.24|||ANCOVA||||
1767020|NCT00043186|3244276|Superiority or Other||Mean Difference (Final Values)|3.95||||0.009||95.0|1.22|6.68|||ANCOVA||||
1767021|NCT00043186|3244276|Superiority or Other||Mean Difference (Final Values)|3.65||||0.009||95.0|1.25|6.05|||ANCOVA||||
1767022|NCT00043186|3244276|Superiority or Other||Mean Difference (Final Values)|4.41||||0.002||95.0|2.07|6.75|||ANCOVA||||
1767023|NCT00043186|3244276|Superiority or Other||Mean Difference (Final Values)|4.2||||0.005||95.0|1.65|6.75|||ANCOVA||||
1767024|NCT00043186|3244276|Superiority or Other||Mean Difference (Final Values)|1.32||||0.275||95.0|-1.06|3.7|||ANCOVA||||
1767025|NCT00043186|3244276|Superiority or Other||Mean Difference (Final Values)|6.16|||<|0.001||95.0|3.63|8.68|||ANCOVA||||
1767026|NCT00043186|3244277|Superiority or Other||Mean Difference (Final Values)|4.23|||<|0.001||95.0|2.76|5.69|||ANCOVA||||
1767027|NCT00043186|3244277|Superiority or Other||Mean Difference (Final Values)|4.55|||<|0.001||95.0|3.12|5.98|||ANCOVA||||
1767028|NCT00043186|3244277|Superiority or Other||Mean Difference (Final Values)|6.09|||<|0.001||95.0|4.53|7.64|||ANCOVA||||
1767029|NCT00043186|3244277|Superiority or Other||Mean Difference (Final Values)|2.53|||<|0.001||95.0|1.13|3.94|||ANCOVA||||
1767030|NCT00043186|3244277|Superiority or Other||Mean Difference (Final Values)|4.22|||<|0.001||95.0|2.85|5.58|||ANCOVA||||
1767031|NCT00043186|3244277|Superiority or Other||Mean Difference (Final Values)|4.64|||<|0.001||95.0|3.19|6.09|||ANCOVA||||
1767032|NCT00043186|3244277|Superiority or Other||Mean Difference (Final Values)|4.4|||<|0.001||95.0|2.95|5.84|||ANCOVA||||
1767033|NCT00043186|3244277|Superiority or Other||Mean Difference (Final Values)|3.14|||<|0.001||95.0|1.71|4.56|||ANCOVA||||
1767034|NCT00043186|3244278|Superiority or Other||Mean Difference (Final Values)|2.03||||0.004||95.0|0.8|3.27|||ANCOVA||||
1767035|NCT00043186|3244278|Superiority or Other||Mean Difference (Final Values)|2.02||||0.004||95.0|0.78|3.26|||ANCOVA||||
1767036|NCT00043186|3244278|Superiority or Other||Mean Difference (Final Values)|2.95|||<|0.001||95.0|1.65|4.26|||ANCOVA||||
1767037|NCT00043186|3244278|Superiority or Other||Mean Difference (Final Values)|0.77|||<|0.202||95.0|-0.41|1.95|||ANCOVA||||
1767038|NCT00043186|3244278|Superiority or Other||Mean Difference (Final Values)|2.72|||<|0.001||95.0|1.54|3.91|||ANCOVA||||
1767039|NCT00043186|3244278|Superiority or Other||Mean Difference (Final Values)|2.0|||<|0.004||95.0|0.74|3.25|||ANCOVA||||
1767040|NCT00043186|3244278|Superiority or Other||Mean Difference (Final Values)|1.73|||<|0.005||95.0|0.52|2.93|||ANCOVA||||
1767041|NCT00043186|3244278|Superiority or Other||Mean Difference (Final Values)|2.3|||<|0.001||95.0|1.09|3.51|||ANCOVA||||
1767042|NCT00043186|3244279|Superiority or Other||Mean Difference (Final Values)|6.39|||<|0.001||95.0|4.49|8.28|||ANCOVA||||
1767043|NCT00043186|3244279|Superiority or Other||Mean Difference (Final Values)|6.05|||<|0.001||95.0|4.0|8.1|||ANCOVA||||
1767044|NCT00043186|3244279|Superiority or Other||Mean Difference (Final Values)|3.74|||<|0.001||95.0|1.71|5.77|||ANCOVA||||
1767045|NCT00043186|3244279|Superiority or Other||Mean Difference (Final Values)|2.0|||<|0.054||95.0|-0.04|4.04|||ANCOVA||||
1767046|NCT00043186|3244279|Superiority or Other||Mean Difference (Final Values)|5.72|||<|0.001||95.0|3.7|7.73|||ANCOVA||||
1767047|NCT00043186|3244279|Superiority or Other||Mean Difference (Final Values)|6.09|||<|0.001||95.0|3.91|8.26|||ANCOVA||||
1767048|NCT00043186|3244279|Superiority or Other||Mean Difference (Final Values)|6.44|||<|0.001||95.0|4.19|8.7|||ANCOVA||||
1767049|NCT00043186|3244279|Superiority or Other||Mean Difference (Final Values)|6.41|||<|0.001||95.0|4.48|8.34|||ANCOVA||||
1767050|NCT00043186|3244280|Superiority or Other||Mean Difference (Final Values)|7.88||||0.233||95.0|0.78|14.97|||ANCOVA||||
1767051|NCT00043186|3244280|Superiority or Other||Mean Difference (Final Values)|7.18||||0.503||95.0|-2.45|16.81|||ANCOVA||||
1767052|NCT00043186|3244280|Superiority or Other||Mean Difference (Final Values)|7.59||||0.503||95.0|-1.85|17.03|||ANCOVA||||
1767053|NCT00043186|3244280|Superiority or Other||Mean Difference (Final Values)|7.41||||0.503||95.0|-2.19|17.01|||ANCOVA||||
1767054|NCT00043186|3244280|Superiority or Other||Mean Difference (Final Values)|2.68||||0.527||95.0|-6.54|11.89|||ANCOVA||||
1767055|NCT00043186|3244280|Superiority or Other||Mean Difference (Final Values)|5.72||||0.503||95.0|-2.9|14.33|||ANCOVA||||
1767056|NCT00043186|3244280|Superiority or Other||Mean Difference (Final Values)|6.6||||0.527||95.0|-6.38|19.59|||ANCOVA||||
1767104|NCT00043186|3244286|Superiority or Other||Mean Difference (Final Values)|1.41|||<|0.07||95.0|-0.12|2.94|||ANCOVA||||
1767057|NCT00043186|3244280|Superiority or Other||Mean Difference (Final Values)|3.27||||0.496||95.0|-7.16|13.7|||ANCOVA||||
1767058|NCT00043186|3244281|Superiority or Other||Mean Difference (Final Values)|5.63|||<|0.001||95.0|3.96|7.3|||ANCOVA||||
1767059|NCT00043186|3244281|Superiority or Other||Mean Difference (Final Values)|4.7|||<|0.001||95.0|2.92|6.49|||ANCOVA||||
1767060|NCT00043186|3244281|Superiority or Other||Mean Difference (Final Values)|4.7|||<|0.001||95.0|2.89|6.5|||ANCOVA||||
1767061|NCT00043186|3244281|Superiority or Other||Mean Difference (Final Values)|5.73|||<|0.001||95.0|4.12|7.33|||ANCOVA||||
1767062|NCT00043186|3244281|Superiority or Other||Mean Difference (Final Values)|6.33|||<|0.001||95.0|4.75|7.92|||ANCOVA||||
1767063|NCT00043186|3244281|Superiority or Other||Mean Difference (Final Values)|5.56|||<|0.001||95.0|3.87|7.26|||ANCOVA||||
1767064|NCT00043186|3244281|Superiority or Other||Mean Difference (Final Values)|3.77|||<|0.001||95.0|2.14|5.39|||ANCOVA||||
1767065|NCT00043186|3244281|Superiority or Other||Mean Difference (Final Values)|2.69|||<|0.002||95.0|1.01|4.38|||ANCOVA||||
1767066|NCT00043186|3244282|Superiority or Other||Mean Difference (Final Values)|3.39|||<|0.001||95.0|1.86|4.93|||ANCOVA||||
1767067|NCT00043186|3244282|Superiority or Other||Mean Difference (Final Values)|4.08|||<|0.001||95.0|2.48|5.68|||ANCOVA||||
1767068|NCT00043186|3244282|Superiority or Other||Mean Difference (Final Values)|5.26|||<|0.001||95.0|3.78|6.73|||ANCOVA||||
1767069|NCT00043186|3244282|Superiority or Other||Mean Difference (Final Values)|4.67|||<|0.001||95.0|3.23|6.11|||ANCOVA||||
1767070|NCT00043186|3244282|Superiority or Other||Mean Difference (Final Values)|4.09|||<|0.001||95.0|2.55|5.62|||ANCOVA||||
1767071|NCT00043186|3244282|Superiority or Other||Mean Difference (Final Values)|4.26|||<|0.001||95.0|2.73|5.78|||ANCOVA||||
1767072|NCT00043186|3244282|Superiority or Other||Mean Difference (Final Values)|3.58|||<|0.001||95.0|2.06|5.1|||ANCOVA||||
1767073|NCT00043186|3244282|Superiority or Other||Mean Difference (Final Values)|1.99|||<|0.009||95.0|0.49|3.49|||ANCOVA||||
1767074|NCT00043186|3244283|Superiority or Other||Mean Difference (Final Values)|2.86|||<|0.001||95.0|1.47|4.24|||ANCOVA||||
1767075|NCT00043186|3244283|Superiority or Other||Mean Difference (Final Values)|2.37|||<|0.001||95.0|0.99|3.76|||ANCOVA||||
1767076|NCT00043186|3244283|Superiority or Other||Mean Difference (Final Values)|3.07|||<|0.001||95.0|1.65|4.49|||ANCOVA||||
1767077|NCT00043186|3244283|Superiority or Other||Mean Difference (Final Values)|2.91|||<|0.001||95.0|1.6|4.21|||ANCOVA||||
1767078|NCT00043186|3244283|Superiority or Other||Mean Difference (Final Values)|3.26|||<|0.001||95.0|1.94|4.57|||ANCOVA||||
1767079|NCT00043186|3244283|Superiority or Other||Mean Difference (Final Values)|3.04|||<|0.001||95.0|1.68|4.4|||ANCOVA||||
1767080|NCT00043186|3244283|Superiority or Other||Mean Difference (Final Values)|3.06|||<|0.001||95.0|1.69|4.42|||ANCOVA||||
1767081|NCT00043186|3244283|Superiority or Other||Mean Difference (Final Values)|1.44|||<|0.033||95.0|0.11|2.76|||ANCOVA||||
1767082|NCT00043186|3244284|Superiority or Other||Mean Difference (Final Values)|8.97|||<|0.001||95.0|7.23|10.72|||ANCOVA||||
1767083|NCT00043186|3244284|Superiority or Other||Mean Difference (Final Values)|7.55|||<|0.001||95.0|5.72|9.38|||ANCOVA||||
1767084|NCT00043186|3244284|Superiority or Other||Mean Difference (Final Values)|7.38|||<|0.001||95.0|5.45|9.31|||ANCOVA||||
1767085|NCT00043186|3244284|Superiority or Other||Mean Difference (Final Values)|8.34|||<|0.001||95.0|6.7|9.99|||ANCOVA||||
1767086|NCT00043186|3244284|Superiority or Other||Mean Difference (Final Values)|9.58|||<|0.001||95.0|7.95|11.21|||ANCOVA||||
1767087|NCT00043186|3244284|Superiority or Other||Mean Difference (Final Values)|8.52|||<|0.001||95.0|6.74|10.3|||ANCOVA||||
1767088|NCT00043186|3244284|Superiority or Other||Mean Difference (Final Values)|2.16|||<|0.015||95.0|0.43|3.89|||ANCOVA||||
1767089|NCT00043186|3244284|Superiority or Other||Mean Difference (Final Values)|4.69|||<|0.001||95.0|2.97|6.41|||ANCOVA||||
1767090|NCT00043186|3244285|Superiority or Other||Mean Difference (Final Values)|6.97||||0.001||95.0|3.28|10.66|||ANCOVA||||
1767091|NCT00043186|3244285|Superiority or Other||Mean Difference (Final Values)|5.94||||0.003||95.0|2.53|9.36|||ANCOVA||||
1767092|NCT00043186|3244285|Superiority or Other||Mean Difference (Final Values)|4.33||||0.047||95.0|0.61|8.05|||ANCOVA||||
1767093|NCT00043186|3244285|Superiority or Other||Mean Difference (Final Values)|6.5|||<|0.001||95.0|3.59|9.41|||ANCOVA||||
1767094|NCT00043186|3244285|Superiority or Other||Mean Difference (Final Values)|8.29|||<|0.001||95.0|5.26|11.33|||ANCOVA||||
1767095|NCT00043186|3244285|Superiority or Other||Mean Difference (Final Values)|6.66|||<|0.001||95.0|3.14|10.18|||ANCOVA||||
1767096|NCT00043186|3244285|Superiority or Other||Mean Difference (Final Values)|-0.71|||<|0.677||95.0|-4.1|2.68|||ANCOVA||||
1767097|NCT00043186|3244285|Superiority or Other||Mean Difference (Final Values)|4.94|||<|0.002||95.0|1.86|8.02|||ANCOVA||||
1767098|NCT00043186|3244286|Superiority or Other||Mean Difference (Final Values)|7.63|||<|0.001||95.0|6.02|9.24|||ANCOVA||||
1767099|NCT00043186|3244286|Superiority or Other||Mean Difference (Final Values)|7.26|||<|0.001||95.0|5.56|8.95|||ANCOVA||||
1767100|NCT00043186|3244286|Superiority or Other||Mean Difference (Final Values)|1.61|||<|0.07||95.0|-0.12|3.35|||ANCOVA||||
1767101|NCT00043186|3244286|Superiority or Other||Mean Difference (Final Values)|7.15|||<|0.001||95.0|5.62|8.69|||ANCOVA||||
1767102|NCT00043186|3244286|Superiority or Other||Mean Difference (Final Values)|8.67|||<|0.001||95.0|7.13|10.21|||ANCOVA||||
1767103|NCT00043186|3244286|Superiority or Other||Mean Difference (Final Values)|7.17|||<|0.001||95.0|5.54|8.8|||ANCOVA||||
1767164|NCT00043186|3244294|Superiority or Other||||||<|0.012|||||||Wilcoxon (Mann-Whitney)||||
1767105|NCT00043186|3244286|Superiority or Other||Mean Difference (Final Values)|3.78|||<|0.001||95.0|2.19|5.36|||ANCOVA||||
1767106|NCT00043186|3244287|Superiority or Other||Mean Difference (Final Values)|5.97|||<|0.001||95.0|4.76|7.17|||ANCOVA||||
1767107|NCT00043186|3244287|Superiority or Other||Mean Difference (Final Values)|5.48|||<|0.001||95.0|4.29|6.67|||ANCOVA||||
1767108|NCT00043186|3244287|Superiority or Other||Mean Difference (Final Values)|6.95|||<|0.001||95.0|5.69|8.21|||ANCOVA||||
1767109|NCT00043186|3244287|Superiority or Other||Mean Difference (Final Values)|4.54|||<|0.001||95.0|3.41|5.67|||ANCOVA||||
1767110|NCT00043186|3244287|Superiority or Other||Mean Difference (Final Values)|6.89|||<|0.001||95.0|5.76|8.01|||ANCOVA||||
1767111|NCT00043186|3244287|Superiority or Other||Mean Difference (Final Values)|5.59|||<|0.001||95.0|4.4|6.78|||ANCOVA||||
1767112|NCT00043186|3244287|Superiority or Other||Mean Difference (Final Values)|6.1|||<|0.001||95.0|4.93|7.27|||ANCOVA||||
1767113|NCT00043186|3244287|Superiority or Other||Mean Difference (Final Values)|5.19|||<|0.001||95.0|4.04|6.34|||ANCOVA||||
1767114|NCT00043186|3244288|Superiority or Other||Mean Difference (Final Values)|3.46|||<|0.001||95.0|2.43|4.48|||ANCOVA||||
1767115|NCT00043186|3244288|Superiority or Other||Mean Difference (Final Values)|3.01|||<|0.001||95.0|1.99|4.04|||ANCOVA||||
1767116|NCT00043186|3244288|Superiority or Other||Mean Difference (Final Values)|3.89|||<|0.001||95.0|2.83|4.95|||ANCOVA||||
1767117|NCT00043186|3244288|Superiority or Other||Mean Difference (Final Values)|2.5|||<|0.001||95.0|1.55|3.46|||ANCOVA||||
1767118|NCT00043186|3244288|Superiority or Other||Mean Difference (Final Values)|4.12|||<|0.001||95.0|3.13|5.11|||ANCOVA||||
1767119|NCT00043186|3244288|Superiority or Other||Mean Difference (Final Values)|3.09|||<|0.001||95.0|2.07|4.11|||ANCOVA||||
1767120|NCT00043186|3244288|Superiority or Other||Mean Difference (Final Values)|2.9|||<|0.001||95.0|1.9|3.89|||ANCOVA||||
1767121|NCT00043186|3244288|Superiority or Other||Mean Difference (Final Values)|2.67|||<|0.001||95.0|1.7|3.64|||ANCOVA||||
1767122|NCT00043186|3244289|Superiority or Other|||||||0.172|||||||Wilcoxon (Mann-Whitney)||||
1767123|NCT00043186|3244289|Superiority or Other|||||||0.168|||||||Wilcoxon (Mann-Whitney)||||
1767124|NCT00043186|3244289|Superiority or Other|||||||0.168|||||||Wilcoxon (Mann-Whitney)||||
1767125|NCT00043186|3244289|Superiority or Other|||||||0.015|||||||Wilcoxon (Mann-Whitney)||||
1767126|NCT00043186|3244289|Superiority or Other|||||||0.047|||||||Wilcoxon (Mann-Whitney)||||
1767127|NCT00043186|3244289|Superiority or Other|||||||0.029|||||||Wilcoxon (Mann-Whitney)||||
1767128|NCT00043186|3244289|Superiority or Other|||||||0.172|||||||Wilcoxon (Mann-Whitney)||||
1767129|NCT00043186|3244289|Superiority or Other|||||||0.01|||||||Wilcoxon (Mann-Whitney)||||
1767130|NCT00043186|3244290|Superiority or Other|||||||0.053|||||||Wilcoxon (Mann-Whitney)||||
1767131|NCT00043186|3244290|Superiority or Other|||||||0.02|||||||Wilcoxon (Mann-Whitney)||||
1767132|NCT00043186|3244290|Superiority or Other|||||||0.053|||||||Wilcoxon (Mann-Whitney)||||
1767133|NCT00043186|3244290|Superiority or Other|||||||0.053|||||||Wilcoxon (Mann-Whitney)||||
1767134|NCT00043186|3244290|Superiority or Other|||||||0.032|||||||Wilcoxon (Mann-Whitney)||||
1767135|NCT00043186|3244290|Superiority or Other|||||||0.022|||||||Wilcoxon (Mann-Whitney)||||
1767136|NCT00043186|3244290|Superiority or Other|||||||0.053|||||||Wilcoxon (Mann-Whitney)||||
1767137|NCT00043186|3244290|Superiority or Other|||||||0.053|||||||Wilcoxon (Mann-Whitney)||||
1767138|NCT00043186|3244291|Superiority or Other|||||||0.005|||||||Wilcoxon (Mann-Whitney)||||
1767139|NCT00043186|3244291|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1767140|NCT00043186|3244291|Superiority or Other|||||||0.002|||||||Wilcoxon (Mann-Whitney)||||
1767141|NCT00043186|3244291|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767142|NCT00043186|3244291|Superiority or Other||||||<|0.002|||||||Wilcoxon (Mann-Whitney)||||
1767143|NCT00043186|3244291|Superiority or Other||||||<|0.077|||||||Wilcoxon (Mann-Whitney)||||
1767144|NCT00043186|3244291|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767145|NCT00043186|3244291|Superiority or Other||||||<|0.011|||||||Wilcoxon (Mann-Whitney)||||
1767146|NCT00043186|3244292|Superiority or Other|||||||0.003|||||||Wilcoxon (Mann-Whitney)||||
1767147|NCT00043186|3244292|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1767148|NCT00043186|3244292|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767149|NCT00043186|3244292|Superiority or Other||||||<|0.409|||||||Wilcoxon (Mann-Whitney)||||
1767150|NCT00043186|3244292|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767151|NCT00043186|3244292|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767152|NCT00043186|3244292|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767153|NCT00043186|3244292|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767154|NCT00043186|3244293|Superiority or Other|||||||0.073|||||||Wilcoxon (Mann-Whitney)||||
1767155|NCT00043186|3244293|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1767156|NCT00043186|3244293|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1767157|NCT00043186|3244293|Superiority or Other|||||||0.032|||||||Wilcoxon (Mann-Whitney)||||
1767158|NCT00043186|3244293|Superiority or Other|||||||0.001|||||||Wilcoxon (Mann-Whitney)||||
1767159|NCT00043186|3244293|Superiority or Other|||||||0.029|||||||Wilcoxon (Mann-Whitney)||||
1767160|NCT00043186|3244293|Superiority or Other|||||||0.05|||||||Wilcoxon (Mann-Whitney)||||
1767161|NCT00043186|3244293|Superiority or Other|||||||0.015|||||||Wilcoxon (Mann-Whitney)||||
1767162|NCT00043186|3244294|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767163|NCT00043186|3244294|Superiority or Other||||||<|0.004|||||||Wilcoxon (Mann-Whitney)||||
1767166|NCT00043186|3244294|Superiority or Other||||||<|0.002|||||||Wilcoxon (Mann-Whitney)||||
1767167|NCT00043186|3244294|Superiority or Other||||||<|0.012|||||||Wilcoxon (Mann-Whitney)||||
1767168|NCT00043186|3244294|Superiority or Other||||||<|0.012|||||||Wilcoxon (Mann-Whitney)||||
1767169|NCT00043186|3244294|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767170|NCT00043186|3244295|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767171|NCT00043186|3244295|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767172|NCT00043186|3244295|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767173|NCT00043186|3244295|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767174|NCT00043186|3244295|Superiority or Other||||||<|0.003|||||||Wilcoxon (Mann-Whitney)||||
1767175|NCT00043186|3244295|Superiority or Other||||||<|0.026|||||||Wilcoxon (Mann-Whitney)||||
1767176|NCT00043186|3244295|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767177|NCT00043186|3244295|Superiority or Other||||||<|0.011|||||||Wilcoxon (Mann-Whitney)||||
1767178|NCT00043186|3244296|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767179|NCT00043186|3244296|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767180|NCT00043186|3244296|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767181|NCT00043186|3244296|Superiority or Other||||||<|0.622|||||||Wilcoxon (Mann-Whitney)||||
1767182|NCT00043186|3244296|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767183|NCT00043186|3244296|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767184|NCT00043186|3244296|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767185|NCT00043186|3244296|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767186|NCT00043186|3244297|Superiority or Other||Mean Difference (Final Values)|11.74|||<|0.001||95.0|8.72|14.76|||ANCOVA||||
1767187|NCT00043186|3244297|Superiority or Other||Mean Difference (Final Values)|12.32|||<|0.001||95.0|9.15|15.49|||ANCOVA||||
1767188|NCT00043186|3244297|Superiority or Other||Mean Difference (Final Values)|11.42|||<|0.001||95.0|8.12|14.73|||ANCOVA||||
1767189|NCT00043186|3244297|Superiority or Other||Mean Difference (Final Values)|12.49|||<|0.001||95.0|9.66|15.32|||ANCOVA||||
1767190|NCT00043186|3244297|Superiority or Other||Mean Difference (Final Values)|12.73|||<|0.001||95.0|9.94|15.52|||ANCOVA||||
1767191|NCT00043186|3244297|Superiority or Other||Mean Difference (Final Values)|14.15|||<|0.001||95.0|11.08|17.21|||ANCOVA||||
1767192|NCT00043186|3244297|Superiority or Other||Mean Difference (Final Values)|4.89|||<|0.001||95.0|1.92|7.85|||ANCOVA||||
1767193|NCT00043186|3244297|Superiority or Other||Mean Difference (Final Values)|6.93|||<|0.001||95.0|3.97|9.89|||ANCOVA||||
1767194|NCT00043186|3244298|Superiority or Other||Mean Difference (Final Values)|6.12||||0.094||95.0|0.57|11.67|||ANCOVA||||
1767195|NCT00043186|3244298|Superiority or Other||Mean Difference (Final Values)|8.95||||0.004||95.0|3.94|13.96|||ANCOVA||||
1767196|NCT00043186|3244298|Superiority or Other||Mean Difference (Final Values)|3.98||||0.292||95.0|-1.42|9.37|||ANCOVA||||
1767197|NCT00043186|3244298|Superiority or Other||Mean Difference (Final Values)|8.37||||0.001||95.0|4.11|12.63|||ANCOVA||||
1767198|NCT00043186|3244298|Superiority or Other||Mean Difference (Final Values)|8.5||||0.001||95.0|4.15|12.86|||ANCOVA||||
1767199|NCT00043186|3244298|Superiority or Other||Mean Difference (Final Values)|8.9||||0.004||95.0|3.72|14.09|||ANCOVA||||
1767200|NCT00043186|3244298|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.992||95.0|-5.07|5.02|||ANCOVA||||
1767201|NCT00043186|3244298|Superiority or Other||Mean Difference (Final Values)|5.42||||0.02||95.0|0.89|9.95|||ANCOVA||||
1767202|NCT00043186|3244299|Superiority or Other||Mean Difference (Final Values)|10.37|||<|0.001||95.0|8.16|12.59|||ANCOVA||||
1767203|NCT00043186|3244299|Superiority or Other||Mean Difference (Final Values)|10.97|||<|0.001||95.0|8.63|13.32|||ANCOVA||||
1767204|NCT00043186|3244299|Superiority or Other||Mean Difference (Final Values)|3.74|||<|0.001||95.0|1.37|6.12|||ANCOVA||||
1767205|NCT00043186|3244299|Superiority or Other||Mean Difference (Final Values)|9.79|||<|0.001||95.0|7.69|11.89|||ANCOVA||||
1767206|NCT00043186|3244299|Superiority or Other||Mean Difference (Final Values)|10.84|||<|0.001||95.0|8.74|12.94|||ANCOVA||||
1767207|NCT00043186|3244299|Superiority or Other||Mean Difference (Final Values)|12.43|||<|0.001||95.0|10.19|14.68|||ANCOVA||||
1767208|NCT00043186|3244299|Superiority or Other||Mean Difference (Final Values)|2.65|||<|0.013||95.0|0.55|4.75|||ANCOVA||||
1767209|NCT00043186|3244299|Superiority or Other||Mean Difference (Final Values)|6.5|||<|0.001||95.0|4.32|8.67|||ANCOVA||||
1767210|NCT00043186|3244300|Superiority or Other||Mean Difference (Final Values)|8.66|||<|0.001||95.0|6.8|10.53|||ANCOVA||||
1767211|NCT00043186|3244300|Superiority or Other||Mean Difference (Final Values)|8.46|||<|0.001||95.0|6.62|10.3|||ANCOVA||||
1767212|NCT00043186|3244300|Superiority or Other||Mean Difference (Final Values)|10.08|||<|0.001||95.0|8.14|12.01|||ANCOVA||||
1767213|NCT00043186|3244300|Superiority or Other||Mean Difference (Final Values)|5.19|||<|0.001||95.0|3.43|6.94|||ANCOVA||||
1767214|NCT00043186|3244300|Superiority or Other||Mean Difference (Final Values)|8.44|||<|0.001||95.0|6.69|10.19|||ANCOVA||||
1767215|NCT00043186|3244300|Superiority or Other||Mean Difference (Final Values)|8.56|||<|0.001||95.0|6.71|10.41|||ANCOVA||||
1767216|NCT00043186|3244300|Superiority or Other||Mean Difference (Final Values)|9.11|||<|0.001||95.0|7.31|10.91|||ANCOVA||||
1767217|NCT00043186|3244300|Superiority or Other||Mean Difference (Final Values)|7.34|||<|0.001||95.0|5.56|9.12|||ANCOVA||||
1767218|NCT00043186|3244302|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767219|NCT00043186|3244302|Superiority or Other||||||<|0.02|||||||Wilcoxon (Mann-Whitney)||||
1767220|NCT00043186|3244302|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767221|NCT00043186|3244302|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767222|NCT00043186|3244302|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767223|NCT00043186|3244302|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767224|NCT00043186|3244302|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767225|NCT00043186|3244302|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767226|NCT00043186|3244303|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767227|NCT00043186|3244303|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767228|NCT00043186|3244303|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767229|NCT00043186|3244303|Superiority or Other||||||<|0.166|||||||Wilcoxon (Mann-Whitney)||||
1767230|NCT00043186|3244303|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767231|NCT00043186|3244303|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767232|NCT00043186|3244303|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767233|NCT00043186|3244303|Superiority or Other||||||<|0.001|||||||Wilcoxon (Mann-Whitney)||||
1767234|NCT00043186|3244304|Superiority or Other||Mean Difference (Final Values)|5.21|||<|0.001||95.0|3.88|6.55|||ANCOVA||||
1767235|NCT00043186|3244304|Superiority or Other||Mean Difference (Final Values)|5.52|||<|0.001||95.0|4.19|6.85|||ANCOVA||||
1767236|NCT00043186|3244304|Superiority or Other||Mean Difference (Final Values)|7.5|||<|0.001||95.0|6.13|8.87|||ANCOVA||||
1767237|NCT00043186|3244304|Superiority or Other||Mean Difference (Final Values)|3.84|||<|0.001||95.0|2.6|5.07|||ANCOVA||||
1767238|NCT00043186|3244304|Superiority or Other||Mean Difference (Final Values)|5.35|||<|0.001||95.0|4.07|6.64|||ANCOVA||||
1767239|NCT00043186|3244304|Superiority or Other||Mean Difference (Final Values)|6.33|||<|0.001||95.0|5.01|7.65|||ANCOVA||||
1767240|NCT00043186|3244304|Superiority or Other||Mean Difference (Final Values)|5.87|||<|0.001||95.0|4.59|7.16|||ANCOVA||||
1767241|NCT00042432|3244305|Superiority or Other||||||<|0.001|||||||ANCOVA|Adusted for baseline glomerular filtration rate (GFR) strata|||
1767242|NCT00042432|3244306|Superiority or Other||Odds Ratio (OR)|5.67||||0.006||95.0|1.6|20.06|||Cochran-Mantel-Haenszel|Adjusted for baseline glomenular filtration rate (GFR) strata|Logit estimates||
1767243|NCT00041938|3244308|Superiority or Other||Rate ratio|1.56|||<|0.001||95.0|1.34|1.81|||Regression, Poisson||Warfarin group represents the numerator and aspirin group represents denominator of rate ratio.||
1767244|NCT00041938|3244309|Superiority or Other||Rate ratio|2.05|||<|0.001|2-Sided|95.0|1.36|3.12|||Regression, Poisson||The warfarin arm represents the numerator and the aspirin arm represents the denominator of the rate ratio.||
1767245|NCT00041938|3244310|Superiority or Other||Hazard Ratio (HR)|1.03||||0.83||95.0|0.81|1.3|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|||
1767246|NCT00041938|3244311|Superiority or Other||Hazard Ratio (HR)|1.77||||0.51|2-Sided|95.0|0.32|9.88|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of myocardial infarction, heart failure hospitalization, ischemic stroke, and death.|
1767247|NCT00041938|3244312|Superiority or Other||Hazard Ratio (HR)|0.55||||0.03|2-Sided|95.0|0.32|0.96|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of myocardial infarction, heart failure hospitalization, death and intracerebral hemorrhage.|
1767248|NCT00041938|3244313|Superiority or Other||Hazard Ratio (HR)|1.21||||0.053|2-Sided|95.0|0.998|1.47|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to heart failure hospitalization, adjusting for competing risks of myocardial infarction, ischemic stroke, intracerebral hemorrhage, and death.|
1767249|NCT00041938|3244314|Superiority or Other||Hazard Ratio (HR)|0.98||||0.93|2-Sided|95.0|0.58|1.64|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to myocardial infarction, adjusting for competing risks of heart failure hospitalization, ischemic stroke, intracerebral hemorrhage, and death.|
1767250|NCT00041938|3244315|Superiority or Other||Hazard Ratio (HR)|1.01||||0.91|2-Sided|95.0|0.85|1.2|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.||
1767251|NCT00041938|3244316|Superiority or Other||Hazard Ratio (HR)|2.22||||0.35||95.0|0.43|11.66|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.||Null hypothesis: there is no difference between warfarin and aspirin in time to intracerebral hemorrhage, adjusting for competing risks of death and ischemic stroke.|
1767252|NCT00041938|3244317|Superiority or Other||Hazard Ratio (HR)|0.52||||0.005|2-Sided|95.0|0.33|0.82|||Regression, Cox|Cause-specific Cox model, stratified by site, NYHA class (I vs. II, III, or IV), and prior stroke or TIA status.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Null hypothesis: there is no difference between warfarin and aspirin in time to ischemic stroke, adjusting for competing risks of death and intracerebral hemorrhage.|
1767253|NCT00041938|3244318|Superiority or Other||Hazard Ratio (HR)|1.07||||0.33|2-Sided|95.0|0.93|1.23||Secondary null hypothesis was tested at two-tailed alpha = 0.05.|Regression, Cox|Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|Secondary null hypothesis: time to first event in the composite secondary endpoint does not differ significantly between warfarin and aspirin. This was tested at prespecified alpha = 0.05 level, two-tailed.|
1767254|NCT00041938|3244319|Superiority or Other||Hazard Ratio (HR)|0.93||||0.4|2-Sided|95.0|0.79|1.1||The primary null hypotheses was tested at two-tailed alpha=0.05. A Haybittle-Peto interim monitoring procedure was performed with stopping boundaries for the interim analyses corresponding to a nominal two-tailed P value of 0.001.|Regression, Cox|Cox models stratified by site, New York Heart Association class (I vs. II-IV), and status w/ respect to recent stroke or Transient Ischemic Attack.|Hazard ratio is for comparison of warfarin vs. aspirin. Warfarin represents the numerator and aspirin represents the denominator of the hazard ratio.|The primary null hypothesis: time to first event in the composite primary endpoint does not differ significantly between warfarin and aspirin. The original target sample size was 2860, providing 89% power for a log-rank test with two-sided alpha .05, assuming a hazard rate reduction of 17.82% in either group compared with the other, after adjustment for use of beta-blockers and allowance for discontinuation of therapy, dropout, and crossover. The final sample of 2305 patients yielded 69% power.|
1767255|NCT00040443|3244343|Other||Mean Difference (Final Values)|5.0|Standard Error of the Mean|1.0|<|0.05|2-Sided|95.0|||||t-test, 2 sided||||
1767256|NCT00039871|3244350|Superiority or Other||Binomial Approximation|0.122||||||95.0|0.076|0.169|||||||
1767257|NCT00039871|3244351|Superiority or Other||Binomial Approximation|0.563||||||95.0|0.529|0.596|||||||
1767258|NCT00039871|3244352|Superiority or Other||Binomial Approximation|0.217||||||99.0|0.195|0.239|||||||
1767259|NCT00039741|3244361|Superiority or Other||Mean Difference (Final Values)|0.06|Standard Error of the Mean|0.13||0.56|2-Sided|95.0|-0.2|0.32|||Interval regression|Adjusted for baseline HIV-1 RNA, age (<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.|||
1767260|NCT00039741|3244361|Superiority or Other||Mean Difference (Final Values)|-0.15|Standard Error of the Mean|0.13||0.26|2-Sided|95.0|-0.41|0.11|||Interval regression|Adjusted for baseline HIV-1 RNA, age (<3 years vs 3 years), origin (PACTG vs PENTA sites), and perinatal ART exposure versus no exposure.|||
1767261|NCT00038948|3244362|Superiority or Other|||||||0.559||||||Tests the equality of rates between treatments across strata at 104 weeks.|Cochran-Mantel-Haenszel|||104 weeks statistical analysis across strata|
1767262|NCT00038948|3244362|Superiority or Other|||||||0.135||||||Tests the equality of rates between treatments across strata at 52 weeks.|Cochran-Mantel-Haenszel|||52 weeks statistical analysis across strata|
1767263|NCT00038948|3244363|Superiority or Other||Weighted difference|1.31||||0.278||95.0|-1.06|3.69||Analysis of covariance p-value|ANCOVA||Data was adjusted for baseline and center.|Baseline GFR of >40.0 mL/min|
1767264|NCT00038948|3244363|Superiority or Other||Weighted difference|-2.68||||0.575||95.0|-12.27|6.91||Analysis of covariance p-value|ANCOVA||Data was adjusted for baseline and center.|Baseline GFR of 20.0 to 40.0 mL/min|
1767265|NCT00038467|3244383|Superiority or Other|||||||0.6449|||||||Chi-squared|||24 months post-treatment: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test.|
1767266|NCT00038467|3244383|Superiority or Other|||||||0.8084|||||||Chi-squared|||12 months post-treatment: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test.|
1767267|NCT00038467|3244383|Superiority or Other|||||||0.0037|||||||Chi-squared|||24 months: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test.|
1767268|NCT00038467|3244383|Superiority or Other|||||||0.0059|||||||Chi-squared|||12 months: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test.|
1767269|NCT00038467|3244383|Superiority or Other|||||||0.0174|||||||Chi-squared|||6 months: p-value for percentage of participants with an endometrial thickness of >=5 mm was analyzed using Chi-squared test.|
1767270|NCT00038467|3244385|Superiority or Other||Mean Difference (Final Values)|-0.36||||0.389|2-Sided|95.0|-1.18|0.46|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.|
1767271|NCT00038467|3244385|Superiority or Other||Mean Difference (Final Values)|-0.61||||0.147|2-Sided|95.0|-1.43|0.21|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.|
1767272|NCT00038467|3244385|Superiority or Other||Mean Difference (Final Values)|0.24||||0.53|2-Sided|95.0|-0.5|0.98|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.|
1767273|NCT00038467|3244385|Superiority or Other||Mean Difference (Final Values)|-0.18||||0.63|2-Sided|95.0|-0.92|0.55|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.|
1767274|NCT00038467|3244385|Superiority or Other||Mean Difference (Final Values)|-0.5||||0.195|2-Sided|95.0|-1.25|0.26|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.|
1767275|NCT00038467|3244385|Superiority or Other||Mean Difference (Final Values)|0.05||||0.876|2-Sided|95.0|-0.62|0.73|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.|
1767276|NCT00038467|3244386|Superiority or Other||Mean Difference (Final Values)|-0.46||||0.244|2-Sided|95.0|-1.24|0.32|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.|
1767277|NCT00038467|3244386|Superiority or Other||Mean Difference (Final Values)|-0.03||||0.932|2-Sided|95.0|-0.77|0.7|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.|
1767278|NCT00038467|3244386|Superiority or Other||Mean Difference (Final Values)|0.24||||0.545|2-Sided|95.0|-0.53|1.0|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.|
1767279|NCT00038467|3244386|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.062|2-Sided|95.0|-1.33|0.03|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.|
1767280|NCT00038467|3244386|Superiority or Other||Mean Difference (Final Values)|-0.34||||0.366|2-Sided|95.0|-1.08|0.4|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.|
1767394|NCT00035932|3244469|Superiority or Other||Difference Estimate|3.2|||||2-Sided|95.0|-9.1|15.4|||||||
1767281|NCT00038467|3244386|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.648|2-Sided|95.0|-0.77|0.48|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.|
1767282|NCT00038467|3244387|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.405|2-Sided|95.0|-0.82|0.33|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.|
1767283|NCT00038467|3244387|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.381|2-Sided|95.0|-0.84|0.32|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.|
1767284|NCT00038467|3244387|Superiority or Other||Mean Difference (Final Values)|0.3||||0.229|2-Sided|95.0|-0.19|0.8|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.|
1767285|NCT00038467|3244387|Superiority or Other||Mean Difference (Final Values)|-0.2||||0.484|2-Sided|95.0|-0.75|0.36|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.|
1767286|NCT00038467|3244387|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.405|2-Sided|95.0|-0.76|0.31|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.|
1767287|NCT00038467|3244387|Superiority or Other||Mean Difference (Final Values)|0.07||||0.792|2-Sided|95.0|-0.42|0.56|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.|
1767288|NCT00038467|3244388|Superiority or Other||Mean Difference (Final Values)|0.12||||0.307|2-Sided|95.0|-0.11|0.34|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.|
1767289|NCT00038467|3244388|Superiority or Other||Mean Difference (Final Values)|0.18||||0.118|2-Sided|95.0|-0.05|0.41|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.|
1767290|NCT00038467|3244388|Superiority or Other||Mean Difference (Final Values)|0.06||||0.604|2-Sided|95.0|-0.16|0.27|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.|
1767291|NCT00038467|3244388|Superiority or Other||Mean Difference (Final Values)|0.01||||0.883|2-Sided|95.0|-0.18|0.21|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.|
1767292|NCT00038467|3244388|Superiority or Other||Mean Difference (Final Values)|0.02||||0.881|2-Sided|95.0|-0.21|0.24|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.|
1767293|NCT00038467|3244388|Superiority or Other||Mean Difference (Final Values)|-0.01||||0.892|2-Sided|95.0|-0.2|0.18|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.|
1767294|NCT00038467|3244389|Superiority or Other||Mean Difference (Final Values)|-0.26||||0.562|2-Sided|95.0|-1.16|0.454|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.|
1767295|NCT00038467|3244389|Superiority or Other||Mean Difference (Final Values)|0.19||||0.604|2-Sided|95.0|-0.54|0.37|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.|
1767296|NCT00038467|3244389|Superiority or Other||Mean Difference (Final Values)|-0.05||||0.882|2-Sided|95.0|-0.76|0.359|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.|
1767297|NCT00038467|3244389|Superiority or Other||Mean Difference (Final Values)|0.05||||0.899|2-Sided|95.0|-0.65|0.356|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.|
1767298|NCT00038467|3244389|Superiority or Other||Mean Difference (Final Values)|0.12||||0.712|2-Sided|95.0|-0.53|0.335|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.|
1767299|NCT00038467|3244390|Superiority or Other||Mean Difference (Final Values)|-0.22||||0.454|2-Sided|95.0|-0.81|0.36|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.|
1767300|NCT00038467|3244390|Superiority or Other||Mean Difference (Final Values)|-0.21||||0.449|2-Sided|95.0|-0.75|0.33|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.|
1767301|NCT00038467|3244390|Superiority or Other||Mean Difference (Final Values)|-0.14||||0.635|2-Sided|95.0|-0.7|0.43|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.|
1767302|NCT00038467|3244390|Superiority or Other||Mean Difference (Final Values)|-0.44||||0.132|2-Sided|95.0|-1.0|0.13|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.|
1767303|NCT00038467|3244390|Superiority or Other||Mean Difference (Final Values)|-1.21||||0.0002|2-Sided|95.0|-1.84|-0.57|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.|
1767304|NCT00038467|3244390|Superiority or Other||Mean Difference (Final Values)|-0.3||||0.265|2-Sided|95.0|-0.83|0.23|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.|
1767305|NCT00038467|3244391|Superiority or Other||Mean Difference (Final Values)|-2.91||||0.126|2-Sided|95.0|-6.63|0.82|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.|
1767306|NCT00038467|3244391|Superiority or Other||Mean Difference (Final Values)|-0.73||||0.643|2-Sided|95.0|-3.83|2.36|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.|
1767307|NCT00038467|3244391|Superiority or Other||Mean Difference (Final Values)|0.91||||0.563|2-Sided|95.0|-2.17|3.99|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.|
1767308|NCT00038467|3244391|Superiority or Other||Mean Difference (Final Values)|-0.9||||0.553|2-Sided|95.0|-3.88|2.08|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.|
1767309|NCT00038467|3244391|Superiority or Other||Mean Difference (Final Values)|-3.08||||0.047|2-Sided|95.0|-6.12|-0.05|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.|
1767310|NCT00038467|3244391|Superiority or Other||Mean Difference (Final Values)|-0.52||||0.727|2-Sided|95.0|-3.46|2.42|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.|
1767311|NCT00038467|3244392|Superiority or Other||Mean Difference (Final Values)|0.42||||0.537|2-Sided|95.0|-0.91|1.75|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.|
1767312|NCT00038467|3244392|Superiority or Other||Mean Difference (Final Values)|-0.16||||0.813|2-Sided|95.0|-1.46|1.15|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.|
1767313|NCT00038467|3244392|Superiority or Other||Mean Difference (Final Values)|0.83||||0.192|2-Sided|95.0|-0.42|2.09|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.|
1767314|NCT00038467|3244392|Superiority or Other||Mean Difference (Final Values)|-0.23||||0.698|2-Sided|95.0|-1.38|0.92|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.|
1767315|NCT00038467|3244392|Superiority or Other||Mean Difference (Final Values)|-0.79||||0.209|2-Sided|95.0|-2.02|0.44|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.|
1767395|NCT00035932|3244470|Superiority or Other||Difference Estimate|0.4|||||2-Sided|95.0|-12.5|13.2|||||ATV 300/RTV - LPV/RTV||
1767316|NCT00038467|3244392|Superiority or Other||Mean Difference (Final Values)|-0.65||||0.26|2-Sided|95.0|-1.8|0.49|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.|
1767317|NCT00038467|3244393|Superiority or Other||Mean Difference (Final Values)|-1.11||||0.187|2-Sided|95.0|-2.76|0.54|||t-test, 2 sided|||24 months: p-value was estimated using 2-sided t-test.|
1767318|NCT00038467|3244393|Superiority or Other||Mean Difference (Final Values)|-0.84||||0.302|2-Sided|95.0|-2.43|0.75|||t-test, 2 sided|||18 months: p-value was estimated using 2-sided t-test.|
1767319|NCT00038467|3244393|Superiority or Other||Mean Difference (Final Values)|0.27||||0.729|2-Sided|95.0|-1.24|1.77|||t-test, 2 sided|||12 months: p-value was estimated using 2-sided t-test.|
1767320|NCT00038467|3244393|Superiority or Other||Mean Difference (Final Values)|-1.35||||0.079|2-Sided|95.0|-2.86|0.16|||t-test, 2 sided|||9 months: p-value was estimated using 2-sided t-test.|
1767321|NCT00038467|3244393|Superiority or Other||Mean Difference (Final Values)|-2.1||||0.009|2-Sided|95.0|-3.67|-0.52|||t-test, 2 sided|||6 months: p-value was estimated using 2-sided t-test.|
1767322|NCT00038467|3244393|Superiority or Other||Mean Difference (Final Values)|-0.45||||0.5|2-Sided|95.0|-1.76|0.86|||t-test, 2 sided|||3 months: p-value was estimated using 2-sided t-test.|
1767323|NCT00038467|3244402|Superiority or Other||Mean Difference (Final Values)|1.9|||<|0.0001|2-Sided|95.0|1.1|2.69|||t-test, 2 sided|||24 months on-treatment (total hip): p-value was estimated using 2-sided t-test.|
1767324|NCT00038467|3244402|Superiority or Other||Mean Difference (Final Values)|3.22|||<|0.0001|2-Sided|95.0|2.1|4.35|||t-test, 2 sided|||24 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.|
1767325|NCT00038467|3244402|Superiority or Other||Mean Difference (Final Values)|1.79|||<|0.0001|2-Sided|95.0|1.12|2.46|||t-test, 2 sided|||12 months on-treatment (total hip): p-value was estimated using 2-sided t-test.|
1767326|NCT00038467|3244402|Superiority or Other||Mean Difference (Final Values)|2.79|||<|0.0001|2-Sided|95.0|1.77|3.81|||t-test, 2 sided|||12 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.|
1767327|NCT00038467|3244402|Superiority or Other||Mean Difference (Final Values)|1.18|||<|0.0002|2-Sided|95.0|0.57|1.79|||t-test, 2 sided|||6 months on-treatment (total hip): p-value was estimated using 2-sided t-test.|
1767328|NCT00038467|3244402|Superiority or Other||Mean Difference (Final Values)|2.43|||<|0.0001|2-Sided|95.0|1.63|3.23|||t-test, 2 sided|||6 months on-treatment (lumbar spine): p-value was estimated using 2-sided t-test.|
1767329|NCT00038467|3244404|Superiority or Other||Hazard Ratio (HR)|0.913||||0.15737|2-Sided|95.0|0.806|1.036|||Log Rank||||
1767330|NCT00038467|3244405|Superiority or Other||Hazard Ratio (HR)|0.69||||3e-05|2-Sided|95.0|0.58|0.82|||Log Rank||||
1767331|NCT00038103|3244413|Superiority or Other||Objective Response Rate|23.5||||||95.0|12.8|37.5|||||Number of subjects showing objective response out of the number of subjects in the evaluable set.||
1767332|NCT00038103|3244413|Superiority or Other||Objective Response Rate|22.4||||||95.0|11.8|36.6|||||Number of subjects showing objective response out of the number of subjects in the evaluable set.||
1767333|NCT00038103|3244414|Superiority or Other||Clinical Benefit Rate|47.1||||||95.0|32.9|61.5|||||Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.||
1767334|NCT00038103|3244414|Superiority or Other||Clinical Benefit Rate|49.0||||||95.0|34.4|63.7|||||Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.||
1767335|NCT00037830|3244415|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1767336|NCT00037830|3244416|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1767337|NCT00037830|3244417|Superiority or Other||||||<|0.01|||||||t-test, 2 sided||||
1767338|NCT00037830|3244418|Superiority or Other||||||<|0.05|||||||t-test, 2 sided|||Analysis was paired sample t-test on change from baseline.|
1767339|NCT00037830|3244419|Superiority or Other|||||||0.131|||||||t-test, 2 sided||||
1767340|NCT00037830|3244420|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided||||
1767341|NCT00037830|3244421|Superiority or Other|||||||0.0003|||||||estimate slope of change over time|random intercept model and a variance components covariance structure|||
1767342|NCT00037830|3244421|Superiority or Other|||||||0.0502|||||||estimate of slope of change over time|random intercept model and a variance components covariance structure|||
1767343|NCT00037830|3244422|Superiority or Other|||||||0.0063|||||||estimate slope of change over time|random intercept model and a variance components covariance structure|||
1767344|NCT00037830|3244422|Superiority or Other|||||||0.1903|||||||estimate of slope of change over time|random intercept model and a variance components covariance structure|||
1767345|NCT00037830|3244423|Superiority or Other|||||||0.0368|||||||t-test, 2 sided|||The null hypothesis for Phase II is that long-term use of GM1 does not affect the progression of PD symptoms and that there is no benefit to early start of GM1 use.|
1767346|NCT00037830|3244424|Superiority or Other||||||<|0.0001|||||||t-test, 2 sided|||The null hypothesis for Phase I was that at week 24, there is no difference between UPDRS motor scores in placebo vs. GM1-treated subjects.|
1767347|NCT00036270|3244431|Superiority or Other||Hazard Ratio (HR)|0.94||||0.293|2-Sided|95.0|0.83|1.06|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|Analysis at 5 years post-randomization. Null hypothesis: no difference in time to relapse between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.|
1767348|NCT00036270|3244433|Superiority or Other||Hazard Ratio (HR)|1.0||||0.951|2-Sided|95.0|0.89|1.14|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|Analysis at 5 years post-randomization. Null hypothesis: no difference in OS between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.|
1767349|NCT00036270|3244434|Superiority or Other||Hazard Ratio (HR)|0.97||||0.604|2-Sided|95.0|0.88|1.08|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|"Analysis at 5 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 5 years.~To maintain overall alpha of 0.05, a nominal alpha of 0.0302 was used."|
1767350|NCT00036270|3244435|Superiority or Other||Hazard Ratio (HR)|0.89||||0.118|2-Sided|95.0|0.77|1.03|||Log Rank|Log rank (Mantel-Cox). Adjusted for overall stratification factor; 1 degree of freedom.|A hazard ratio less than 1 favors the test treatment (exemestane only arm).|"Analysis at 2.75 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 2.75 years.~To maintain overall alpha of 0.05, 2 adjustments made: first, a nominal alpha of 0.0302 was used for the primary endpoint. Second, level of significant was 0.0012 for interim analysis."|
1767351|NCT00035932|3244443|Superiority or Other||time-averaged difference|0.11|||||2-Sided|97.5|-0.16|0.38|||||ATV 300/RTV - LPV/RTV|last observation carried forward|
1767352|NCT00035932|3244443|Superiority or Other||time-averaged difference|0.14|||||2-Sided|97.5|-0.13|0.41|||||ATV 300/RTV - LPV/RTV|overall|
1767353|NCT00035932|3244454|Superiority or Other||Difference Estimate|-19.8|||||2-Sided|95.0|-36.5|1.3|||||ATV 400/SQV - LPV/RTV|observed cases, fasting triglycerides|
1767354|NCT00035932|3244454|Superiority or Other||Difference Estimate|-24.8|||||2-Sided|95.0|-38.6|-8.0|||||ATV 300/RTV - LPV/RTV|observed cases, fasting triglycerides|
1767355|NCT00035932|3244454|Superiority or Other||Difference Estimate|-7.9|||||2-Sided|95.0|-19.0|4.8|||||ATV 400/SQV - LPV/RTV|Observed Cases, Fasting LDL cholesterol|
1767356|NCT00035932|3244454|Superiority or Other||Difference Estimate|-12.7|||||2-Sided|95.0|-22.3|-1.8|||||ATV 300/RTV - LPV/RTV|observed cases, fasting LDL|
1767357|NCT00035932|3244454|Superiority or Other||Difference Estimate|-4.1|||||2-Sided|95.0|-14.0|7.0|||||ATV 400/SQV - LPV/RTV|Observed values, HDL cholesterol|
1767358|NCT00035932|3244454|Superiority or Other||Difference Estimate|-11.0|||||2-Sided|95.0|-19.9|-1.2|||||ATV 300/RTV - LPV/RTV|observed values, HDL cholesterol|
1767359|NCT00035932|3244454|Superiority or Other||Difference Estimate|-9.0|||||2-Sided|95.0|-16.1|-1.3|||||ATV 400/SQV - LPV/RTV|observed values, total cholesterol|
1767360|NCT00035932|3244454|Superiority or Other||Difference Estimate|-14.4|||||2-Sided|95.0|-20.1|-8.3|||||ATV 300/RTV - LPV/RTV|Observed values, Total Cholesterol|
1767361|NCT00035932|3244455|Superiority or Other||Difference Estimate|-38.4|||||2-Sided|95.0|-49.7|-27.1||||||Fasting Triglycerides|
1767362|NCT00035932|3244455|Superiority or Other||Difference Estimate|-29.6|||||2-Sided|95.0|-41.6|-17.7||||||Fasting Triglycerides|
1767363|NCT00035932|3244455|Superiority or Other||Difference Estimate|-7.4|||||2-Sided|95.0|-17.7|3.0||||||Fasting LDL Cholesterol|
1767364|NCT00035932|3244455|Superiority or Other||Difference Estimate|-8.9|||||2-Sided|95.0|-19.0|1.2||||||Fasting LDL CHolesterol|
1767365|NCT00035932|3244455|Superiority or Other||DIfference Estimate|-0.8|||||2-Sided|95.0|-11.0|9.3||||||HDL Cholesterol|
1767366|NCT00035932|3244455|Superiority or Other||Difference Estimate|-4.4|||||2-Sided|95.0|-12.4|3.5||||||HDL Cholesterol|
1767367|NCT00035932|3244455|Superiority or Other||Difference Estimate|-12.0|||||2-Sided|95.0|-17.4|-6.5||||||Total Cholesterol|
1767368|NCT00035932|3244455|Superiority or Other||Difference Estimate|-12.1|||||2-Sided|95.0|-17.0|-7.2||||||Total Cholesterol|
1767369|NCT00035932|3244456|Superiority or Other||Difference Estimate|-34.2|||||2-Sided|95.0|-43.4|-23.4||||||Fasting Triglycerides|
1767370|NCT00035932|3244456|Superiority or Other||Difference Estimate|-24.9|||||2-Sided|95.0|-35.0|-13.2||||||Fasting Triglycerides|
1767371|NCT00035932|3244456|Superiority or Other||Difference Estimate|-7.3|||||2-Sided|95.0|-15.5|1.8||||||Fasting LDL Cholesterol|
1767372|NCT00035932|3244456|Superiority or Other||Difference Estimate|-6.8|||||2-Sided|95.0|-15.6|3.0||||||Fasting LDL Cholesterol|
1767373|NCT00035932|3244456|Superiority or Other||Difference Estimate|-1.0|||||2-Sided|95.0|-9.3|8.1||||||HDL Cholesterol|
1767374|NCT00035932|3244456|Superiority or Other||Difference Estimate|-6.7|||||2-Sided|95.0|-13.6|0.7||||||HDL cholesterol|
1767375|NCT00035932|3244456|Superiority or Other||Difference Estimate|-12.4|||||2-Sided|95.0|-16.9|-7.6||||||Total Cholesterol|
1767376|NCT00035932|3244456|Superiority or Other||Difference Estimate|-10.9|||||2-Sided|95.0|-15.5|-6.0||||||Total Cholesterol|
1767377|NCT00035932|3244458|Superiority or Other||||||<|0.05||||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between # of PI Mutations at baseline (<4; >=4) of ATV 300 mg / RTV and CD4 Cell Count|
1767378|NCT00035932|3244458|Superiority or Other||||||<|0.05||||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between IQ (<10; >=10) of ATV 300 mg / RTV and CD4 Cell Count|
1767379|NCT00035932|3244458|Superiority or Other||||||<|0.05||||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between ATV Cmin of ATV 300 mg / RTV and CD4 Cell Count|
1767380|NCT00035932|3244460|Superiority or Other||||||<|0.05||||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between number of PI Mutations at baseline (<4; >=4) of ATV 400 mg / SQV and HIV RNA|
1767381|NCT00035932|3244460|Superiority or Other||||||<|0.05||||||P-value was based on a t-distribution.|t-test, 1 sided|||Correlation between IQ (<10; >=10) of ATV 300 mg / RTV and HIV RNA|
1767382|NCT00035932|3244462|Superiority or Other||Time-Averaged Difference|-47.6|||||2-Sided|97.5|-79.2|-16.1|||||||
1767383|NCT00035932|3244462|Superiority or Other||Time-Averaged Difference|-17.5|||||2-Sided|97.5|-45.6|10.6|||||||
1767384|NCT00035932|3244463|Superiority or Other||Time-Averaged Difference|-44.9|||||2-Sided|97.5|-74.5|-15.3|||||||
1767385|NCT00035932|3244463|Superiority or Other||Time-Averaged Difference|-18.4|||||2-Sided|97.5|-44.3|7.5|||||||
1767386|NCT00035932|3244465|Superiority or Other||Difference Estimate|-17.9|||||2-Sided|95.0|-29.9|-5.9|||||||
1767387|NCT00035932|3244465|Superiority or Other||Difference Estimate|-6.4|||||2-Sided|95.0|-18.7|5.8|||||||
1767388|NCT00035932|3244466|Superiority or Other||Difference Estimate|-18.9|||||2-Sided|95.0|-30.7|-7.1|||||||
1767389|NCT00035932|3244466|Superiority or Other||Difference Estimate|-2.3|||||2-Sided|95.0|-14.6|10.0|||||||
1767390|NCT00035932|3244467|Superiority or Other||Difference Estimate|-2.4|||||2-Sided|95.0|-15.0|10.3|||||ATV 300/RTV - LPV/RTV||
1767391|NCT00035932|3244468|Superiority or Other||Difference Estimate|-17.9|||||2-Sided|95.0|-30.6|-5.3|||||||
1767392|NCT00035932|3244468|Superiority or Other||Difference Estimate|-1.1|||||2-Sided|95.0|-13.7|11.4|||||||
1767393|NCT00035932|3244469|Superiority or Other||Difference Estimate|-16.7|||||2-Sided|95.0|-29.4|-4.0|||||||
1767396|NCT00035932|3244472|Superiority or Other||Difference Estimate|-16.1|||||2-Sided|95.0|-28.5|-3.7|||||||
1767397|NCT00035932|3244472|Superiority or Other||Difference Estimate|-5.0|||||2-Sided|95.0|-16.9|7.0|||||||
1767398|NCT00035932|3244474|Superiority or Other||Difference Estimate|-11.3|||||2-Sided|95.0|-22.9|0.4|||||||
1767399|NCT00035932|3244474|Superiority or Other||Difference Estimate|3.6|||||2-Sided|95.0|-7.0|14.1|||||||
1767400|NCT00035932|3244475|Superiority or Other||Difference estimate|-0.5|||||2-Sided|95.0|-13.3|12.3|||||ATV 300/RTV - LPV/RTV|Randomized participants|
1767401|NCT00035932|3244476|Superiority or Other||Time-Averaged Distance|0.33|||||2-Sided|97.5|0.07|0.6|||||||
1767402|NCT00035932|3244476|Superiority or Other||Time-Averaged Difference|0.13|||||2-Sided|97.5|-0.12|0.39|||||||
1767403|NCT00035932|3244479|Superiority or Other||Treatment Difference|0.17|||||2-Sided|95.0|-0.01|0.35|||||||
1767404|NCT00035932|3244479|Superiority or Other||Treatment Difference|0.13|||||2-Sided|95.0|-0.04|0.3|||||||
1767405|NCT00035932|3244480|Non-Inferiority or Equivalence|The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.|Time-Averaged Difference|0.31|||||2-Sided|97.5|0.07|0.55|||||||
1767406|NCT00035932|3244480|Non-Inferiority or Equivalence|The time-averaged difference (TAD) in the reduction of log10 HIV RNA levels from baseline through Week 24 was compared pairwise for each atazanavir regimen to the lopinavir/RTV regimen, and assessed using a two-sided 97.5% confidence interval. The primary efficacy analysis was to declare two treatment regimens similar if the upper limit of this 97.5% confidence interval for the difference (atazanavir-lopinavir/RTV) was less than 0.5 log10.|Time-Averaged Difference|0.14|||||2-Sided|97.5|-0.09|0.37|||||||
1767407|NCT00035815|3244481|Superiority or Other|||||||0.321|||||||Wilcoxon (Mann-Whitney)|||The final secondary outcome measure was the rate of change in the ALSFRS-r score. The ALSFRS-r was completed at each visit (randomization and then at 3, 6, 12, 18 and 24 months post-randomization). As with the MMT scores a score of 0 was imputed on the day of death. Analysis of the ALSFRS-r scores as a secondary outcome was performed in similar manner as MMT score.|
1767408|NCT00035815|3244482|Superiority or Other||Cox Proportional Hazard|1.04||||0.415|2-Sided|95.0|0.77|1.4|||Regression, Cox|||Patients who elected to proceed to tracheostomy were assessed on the day of their procedure. Subjects who continuously utilized NIPPV for greater than 10 days were assessed as being ventilator-dependent on the first day they began continuous NIPPV. Survival between groups was compared using the Cox-proportional Hazards model.|
1767409|NCT00035815|3244483|Superiority or Other|||||||0.529|||||||Wilcoxon (Mann-Whitney)|||Analysis of MMT was calculated as a ratio of change from baseline to last follow-up to time to duration until last follow-up. For the patients that died during the study period, the last follow-up time was considered as the time of death with a zero score for MMT measurement. Analysis was performed using intention to treat approach. Comparison of rate of change in MMT scores between the placebo and IGF-1 group was made using two sample t-test or Wilcoxon rank sum test as appropriate.|
1767410|NCT00032591|3244504|Non-Inferiority or Equivalence|A target of 363 patients with primary events required to discern a 32% relative drop in annual primary event rates with 90% power (from 5.5% for HQACM to 3.75% for PST) was based on a sample size of 3200 patients with 1 year of enrollment and a minimum of 2 years follow-up. Due to slower than planned enrollment, we randomized 2922 patients over 2.75 years, with a mean follow-up of 3 years.|Hazard Ratio (HR)|0.88||||0.14|||||||Log Rank|||The null hypothesis was the hazard ratio was equal to 1.|
1767411|NCT00032487|3244506|Non-Inferiority or Equivalence|The statistical analysis tested was for equivalence. We assumed 86% power with 21% of effect size and the sample size 1700 with 5% drop out rate.|Cox Proportional Hazard|0.79|||<|0.05|2-Sided|95.0|0.79|0.99|||Log Rank|||It was hypothesized 21% reduction in intensive glycemic control group compared to standard control group on primary cardiovascular composite outcomes.|
1767412|NCT00029146|3244537|Superiority or Other||Difference in estimated 2 yr rates|1.5||||0.81|2-Sided|95.0|-10.7|13.7|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.||Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.|
1767413|NCT00029146|3244538|Superiority or Other||Mean Difference (Final Values)|-0.24||||0.13|2-Sided|95.0|-0.54|0.07|||t-test, 2 sided||Negative indicates lower score in non-surgical group.A higher score indicates better quality of life||
1767414|NCT00029146|3244539|Superiority or Other|||||||0.85|||||||Fisher's Exact Test||||
1767415|NCT00029146|3244540|Superiority or Other||Difference in estimated 2 yr rates|4.4||||0.7|2-Sided|95.0|-8.2|16.9|||Fisher Exact||Positive indicates lower rate in surgical group In this case, lower rate is worse since Rankin 0-2 indicates a good outcome.||
1767416|NCT00029146|3244541|Superiority or Other||Difference in estimated 2 yr rates|-6.6||||0.41|2-Sided|95.0|-20.6|7.3|||Fisher Exact||Negative indicates lower rate in non-surgical group. In this case, lower rate is worse since Rankin 0-1 indicates a good outcome.||
1767417|NCT00029146|3244542|Superiority or Other||Difference in estimated 2 yr rates|6.5||||0.33|2-Sided|95.0|-6.5|19.6|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.|
1767418|NCT00029146|3244543|Superiority or Other||Difference in estimated 2 yr rates|4.0||||0.13|2-Sided|95.0|-1.2|9.7|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.|
1767459|NCT00023595|3244570|Superiority|||||||0.049||||||24 months|Chi-squared||||
1767419|NCT00029146|3244544|Superiority or Other||Difference in estimated 2 yr rates|1.3||||0.5|2-Sided|95.0|-2.5|5.2|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.|
1767420|NCT00029146|3244545|Superiority or Other||Difference in estimated 2 yr rates|-3.2||||0.27|2-Sided|95.0|-9.0|2.6|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Negative indicates lower rate in non-surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.|
1767421|NCT00029146|3244546|Superiority or Other||Difference in estimated 2 yr rates|3.5||||0.59|2-Sided|95.0|-9.2|16.1|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors.|
1767422|NCT00029146|3244547|Superiority or Other||Difference in estimated 2 yr rates|1.7||||0.78||95.0|-10.4|13.8|||2-sided z-statistic|The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.|Positive indicates lower rate in surgical group|Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference. The 2-sided z-statistic was compared to a standard unit normal distribution.The study was terminated early for futility after 195 of the planned 372 participants were enrolled.|
1767423|NCT00028093|3244550|Superiority or Other|||||||0.54|||||||Wilcoxon (Mann-Whitney)|||Null hypothesis: there is no difference in the outcome between the two groups|
1767424|NCT00027378|3244552|Superiority or Other||Mean Difference (Final Values)|0.39|Standard Deviation|0.702||0.05||95.0|||||ANOVA|repeated measures||Repeated measures ANOVA|
1767425|NCT00025883|3244561|Superiority or Other|||||||0.02|||||||Mixed Models Analysis|||Triglycerides were log transformed for analysis due to non-normal distribution. Changes in triglycedies in response to metreleptin over three time points (baseline, 6 months, 12 months) are tested within PLD group.|
1767426|NCT00025883|3244561|Superiority or Other|||||||0.05|||||||Mixed Models Analysis|||Triglycerides were log transformed for analysis due to non-normal distribution. Changes in triglycedies in response to metreleptin over three time points (baseline, 6 months, 12 months) are tested within GLD group.|
1767427|NCT00025883|3244562|Superiority or Other|||||||0.004|||||||Mixed Models Analysis|||A null hypothesis of interest is there is no significant change over three time points (baseline, 6 months, 12 months) in response to metreleptin within PLD group.|
1767428|NCT00025883|3244562|Superiority or Other||||||<|0.001|||||||Mixed Models Analysis|||A null hypothesis of interest is there is no significant change over three time points (baseline, 6 months, 12 months) in response to metreleptin within GLD group.|
1767429|NCT00023595|3244563|Superiority|||||||0.004||||||Total index cost|Wilcoxon (Mann-Whitney)||||
1767430|NCT00023595|3244563|Superiority||||||<|0.0001||||||Physician fees|Wilcoxon (Mann-Whitney)||||
1767431|NCT00023595|3244563|Superiority||||||<|0.006||||||Hospital costs|Wilcoxon (Mann-Whitney)||||
1767432|NCT00023595|3244564|Superiority||||||<|0.0001||||||Total index cost|Wilcoxon (Mann-Whitney)||||
1767433|NCT00023595|3244564|Superiority||||||<|0.0001||||||Physician fees|Wilcoxon (Mann-Whitney)||||
1767434|NCT00023595|3244564|Superiority||||||<|0.0001||||||Hospital costs|Wilcoxon (Mann-Whitney)||||
1767435|NCT00023595|3244565|Superiority|||||||0.84||||||36 months|Wilcoxon (Mann-Whitney)||||
1767436|NCT00023595|3244565|Superiority|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)||||
1767437|NCT00023595|3244565|Superiority|||||||0.57||||||12 months|Wilcoxon (Mann-Whitney)||||
1767438|NCT00023595|3244565|Superiority|||||||0.14||||||4 months|Wilcoxon (Mann-Whitney)||||
1767439|NCT00023595|3244565|Superiority|||||||0.6||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767440|NCT00023595|3244566|Superiority|||||||0.32||||||36 months|Chi-squared||||
1767441|NCT00023595|3244566|Superiority|||||||0.009||||||24 months|Chi-squared||||
1767442|NCT00023595|3244566|Superiority||||||<|0.0001||||||12 months|Chi-squared||||
1767443|NCT00023595|3244566|Superiority||||||<|0.0002||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767444|NCT00023595|3244567|Superiority|||||||0.12||||||36 months|Wilcoxon (Mann-Whitney)||||
1767445|NCT00023595|3244567|Superiority|||||||0.52||||||24 months|Wilcoxon (Mann-Whitney)||||
1767446|NCT00023595|3244567|Superiority|||||||0.77||||||12 months|Wilcoxon (Mann-Whitney)||||
1767447|NCT00023595|3244567|Superiority|||||||0.72||||||4 months|Wilcoxon (Mann-Whitney)||||
1767448|NCT00023595|3244567|Superiority|||||||0.75||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767449|NCT00023595|3244568|Superiority|||||||0.037||||||36 months|Chi-squared||||
1767450|NCT00023595|3244568|Superiority|||||||0.018||||||24 months|Chi-squared||||
1767451|NCT00023595|3244568|Superiority|||||||0.043||||||12 months|Chi-squared||||
1767452|NCT00023595|3244568|Superiority|||||||0.036||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767453|NCT00023595|3244569|Superiority|||||||0.04||||||36 months|Wilcoxon (Mann-Whitney)||||
1767454|NCT00023595|3244569|Superiority|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)||||
1767455|NCT00023595|3244569|Superiority|||||||0.98||||||12 months|Wilcoxon (Mann-Whitney)||||
1767456|NCT00023595|3244569|Superiority|||||||0.37||||||4 months|Wilcoxon (Mann-Whitney)||||
1767457|NCT00023595|3244569|Superiority|||||||0.4||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767458|NCT00023595|3244570|Superiority|||||||0.038||||||36 months|Chi-squared||||
1767460|NCT00023595|3244570|Superiority|||||||0.007||||||12 months|Chi-squared||||
1767461|NCT00023595|3244570|Superiority|||||||0.002||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767462|NCT00023595|3244571|Superiority|||||||0.25||||||36 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.|||
1767463|NCT00023595|3244571|Superiority|||||||0.25||||||24 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.|||
1767464|NCT00023595|3244571|Superiority|||||||0.41||||||12 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.|||
1767465|NCT00023595|3244571|Superiority|||||||0.42||||||4 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.|||
1767466|NCT00023595|3244571|Superiority|||||||0.4||||||Baseline|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.|||
1767467|NCT00023595|3244572|Superiority|||||||0.031||||||36 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.|||
1767468|NCT00023595|3244572|Superiority|||||||0.027||||||24 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.|||
1767469|NCT00023595|3244572|Superiority|||||||0.55||||||12 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.|||
1767470|NCT00023595|3244572|Superiority|||||||0.78||||||4 months|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.|||
1767471|NCT00023595|3244572|Superiority|||||||0.86||||||Baseline|Chi-squared|All P-values were based on the Likelihood Ratio Chi-Square test.|||
1767472|NCT00023595|3244573|Superiority|||||||0.38||||||36 months|Wilcoxon (Mann-Whitney)||||
1767473|NCT00023595|3244573|Superiority|||||||0.95||||||24 months|Wilcoxon (Mann-Whitney)||||
1767474|NCT00023595|3244573|Superiority|||||||0.57||||||12 months|Wilcoxon (Mann-Whitney)||||
1767475|NCT00023595|3244573|Superiority|||||||0.43||||||4 months|Wilcoxon (Mann-Whitney)||||
1767476|NCT00023595|3244573|Superiority|||||||0.31||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767477|NCT00023595|3244574|Superiority|||||||0.06||||||36 months|Chi-squared||||
1767478|NCT00023595|3244574|Superiority|||||||0.023||||||24 months|Chi-squared||||
1767479|NCT00023595|3244574|Superiority|||||||0.003||||||12 months|Chi-squared||||
1767480|NCT00023595|3244574|Superiority|||||||0.007||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767481|NCT00023595|3244575|Superiority|||||||0.21||||||36 months|Wilcoxon (Mann-Whitney)||||
1767482|NCT00023595|3244575|Superiority|||||||0.78||||||24 months|Wilcoxon (Mann-Whitney)||||
1767483|NCT00023595|3244575|Superiority|||||||0.37||||||12 months|Wilcoxon (Mann-Whitney)||||
1767484|NCT00023595|3244575|Superiority|||||||0.53||||||4 months|Wilcoxon (Mann-Whitney)||||
1767485|NCT00023595|3244575|Superiority|||||||0.96||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767486|NCT00023595|3244576|Superiority|||||||0.001|||||||Chi-squared||||
1767487|NCT00023595|3244576|Superiority|||||||0.001||||||24 months|Chi-squared||||
1767488|NCT00023595|3244576|Superiority||||||<|0.001||||||12 months|Chi-squared||||
1767489|NCT00023595|3244576|Superiority||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767490|NCT00023595|3244577|Superiority|||||||0.68||||||36 months|Wilcoxon (Mann-Whitney)||||
1767491|NCT00023595|3244577|Superiority|||||||0.15||||||24 months|Wilcoxon (Mann-Whitney)||||
1767492|NCT00023595|3244577|Superiority|||||||0.65||||||12 months|Wilcoxon (Mann-Whitney)||||
1767493|NCT00023595|3244577|Superiority|||||||0.39||||||4 months|Wilcoxon (Mann-Whitney)||||
1767494|NCT00023595|3244577|Superiority|||||||0.86||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767495|NCT00023595|3244578|Superiority|||||||0.001||||||36 months|Chi-squared||||
1767496|NCT00023595|3244578|Superiority||||||<|0.001||||||24 months|Chi-squared||||
1767497|NCT00023595|3244578|Superiority||||||<|0.001||||||12 months|Chi-squared||||
1767498|NCT00023595|3244578|Superiority||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767499|NCT00023595|3244579|Superiority|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)||||
1767500|NCT00023595|3244579|Superiority|||||||0.95||||||24 months|Wilcoxon (Mann-Whitney)||||
1767501|NCT00023595|3244579|Superiority|||||||0.88||||||12 months|Wilcoxon (Mann-Whitney)||||
1767502|NCT00023595|3244579|Superiority|||||||0.16||||||4 months|Wilcoxon (Mann-Whitney)||||
1767503|NCT00023595|3244579|Superiority|||||||0.98||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767504|NCT00023595|3244580|Superiority|||||||0.2||||||36 months|Chi-squared||||
1767505|NCT00023595|3244580|Superiority|||||||0.3||||||24 months|Chi-squared||||
1767506|NCT00023595|3244580|Superiority|||||||0.042||||||12 months|Chi-squared||||
1767507|NCT00023595|3244580|Superiority|||||||0.029||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767508|NCT00023595|3244581|Superiority|||||||0.27||||||36 months|Wilcoxon (Mann-Whitney)||||
1767509|NCT00023595|3244581|Superiority|||||||0.46||||||24 months|Wilcoxon (Mann-Whitney)||||
1767510|NCT00023595|3244581|Superiority|||||||0.77||||||12 months|Wilcoxon (Mann-Whitney)||||
1767511|NCT00023595|3244581|Superiority|||||||0.74||||||4 months|Wilcoxon (Mann-Whitney)||||
1767512|NCT00023595|3244581|Superiority|||||||0.01||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767513|NCT00023595|3244582|Superiority|||||||0.01||||||36 months|Chi-squared||||
1767514|NCT00023595|3244582|Superiority||||||<|0.001||||||24 months|Chi-squared||||
1767515|NCT00023595|3244582|Superiority||||||<|0.001||||||12 months|Chi-squared||||
1767516|NCT00023595|3244582|Superiority||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767517|NCT00023595|3244583|Superiority|||||||0.89||||||36 months|Wilcoxon (Mann-Whitney)||||
1767518|NCT00023595|3244583|Superiority|||||||0.89||||||24 months|Wilcoxon (Mann-Whitney)||||
1767519|NCT00023595|3244583|Superiority|||||||0.76||||||12 months|Wilcoxon (Mann-Whitney)||||
1767520|NCT00023595|3244583|Superiority|||||||0.26||||||4 months|Wilcoxon (Mann-Whitney)||||
1767521|NCT00023595|3244583|Superiority|||||||0.53||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767522|NCT00023595|3244584|Superiority|||||||0.037||||||36 months|Chi-squared||||
1767523|NCT00023595|3244584|Superiority|||||||0.006||||||24 months|Chi-squared||||
1767524|NCT00023595|3244584|Superiority||||||<|0.001|||||||Chi-squared||||
1767525|NCT00023595|3244584|Superiority||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767526|NCT00023595|3244585|Superiority|||||||0.86||||||36 months|Wilcoxon (Mann-Whitney)||||
1767527|NCT00023595|3244585|Superiority|||||||0.98||||||24 months|Wilcoxon (Mann-Whitney)||||
1767528|NCT00023595|3244585|Superiority|||||||0.66||||||12 months|Wilcoxon (Mann-Whitney)||||
1767529|NCT00023595|3244585|Superiority|||||||0.23||||||4 months|Wilcoxon (Mann-Whitney)||||
1767530|NCT00023595|3244585|Superiority|||||||0.26||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767531|NCT00023595|3244586|Superiority|||||||0.051||||||36 months|Chi-squared||||
1767532|NCT00023595|3244586|Superiority|||||||0.015||||||24 months|Chi-squared||||
1767533|NCT00023595|3244586|Superiority|||||||0.002||||||12 months|Chi-squared||||
1767534|NCT00023595|3244586|Superiority|||||||0.033||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767535|NCT00023595|3244587|Superiority|||||||0.68||||||36 months|Wilcoxon (Mann-Whitney)||||
1767536|NCT00023595|3244587|Superiority|||||||0.25||||||24 months|Wilcoxon (Mann-Whitney)||||
1767537|NCT00023595|3244587|Superiority|||||||0.68||||||12 months|Wilcoxon (Mann-Whitney)||||
1767538|NCT00023595|3244587|Superiority|||||||0.29||||||4 months|Wilcoxon (Mann-Whitney)||||
1767539|NCT00023595|3244587|Superiority|||||||0.63||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767540|NCT00023595|3244588|Superiority|||||||0.17||||||36 months|Chi-squared||||
1767541|NCT00023595|3244588|Superiority|||||||0.077||||||24 months|Chi-squared||||
1767542|NCT00023595|3244588|Superiority|||||||0.001||||||12 months|Chi-squared||||
1767543|NCT00023595|3244588|Superiority|||||||0.023||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767544|NCT00023595|3244589|Superiority|||||||0.82||||||36 months|Wilcoxon (Mann-Whitney)||||
1767545|NCT00023595|3244589|Superiority|||||||0.84||||||24 months|Wilcoxon (Mann-Whitney)||||
1767546|NCT00023595|3244589|Superiority|||||||0.87||||||12 months|Wilcoxon (Mann-Whitney)||||
1767547|NCT00023595|3244589|Superiority|||||||0.47||||||4 months|Wilcoxon (Mann-Whitney)||||
1767548|NCT00023595|3244589|Superiority|||||||0.7||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767549|NCT00023595|3244590|Superiority|||||||0.018||||||36 months|Chi-squared||||
1767550|NCT00023595|3244590|Superiority||||||<|0.001||||||24 months|Chi-squared||||
1767551|NCT00023595|3244590|Superiority||||||<|0.001||||||12 month|Chi-squared||||
1767552|NCT00023595|3244590|Superiority||||||<|0.001||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767553|NCT00023595|3244591|Superiority|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)||||
1767554|NCT00023595|3244591|Superiority|||||||0.78||||||24 months|Wilcoxon (Mann-Whitney)||||
1767555|NCT00023595|3244591|Superiority|||||||0.59||||||12 months|Wilcoxon (Mann-Whitney)||||
1767556|NCT00023595|3244591|Superiority|||||||0.17||||||4 months|Wilcoxon (Mann-Whitney)||||
1767557|NCT00023595|3244591|Superiority|||||||0.18||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767558|NCT00023595|3244592|Superiority|||||||0.085||||||36 months|Chi-squared||||
1767559|NCT00023595|3244592|Superiority|||||||0.026||||||24 months|Chi-squared||||
1767560|NCT00023595|3244592|Superiority|||||||0.007|||||||Chi-squared||||
1767561|NCT00023595|3244592|Superiority|||||||0.085||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767562|NCT00023595|3244593|Superiority|||||||0.48||||||36 months|Wilcoxon (Mann-Whitney)||||
1767563|NCT00023595|3244593|Superiority|||||||0.9||||||24 months|Wilcoxon (Mann-Whitney)||||
1767564|NCT00023595|3244593|Superiority|||||||0.35||||||12 months|Wilcoxon (Mann-Whitney)||||
1767565|NCT00023595|3244593|Superiority|||||||0.43||||||4 months|Wilcoxon (Mann-Whitney)||||
1767566|NCT00023595|3244593|Superiority|||||||0.23||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767567|NCT00023595|3244594|Superiority|||||||0.074||||||36 months|Chi-squared||||
1767568|NCT00023595|3244594|Superiority|||||||0.039||||||24 months|Chi-squared||||
1767569|NCT00023595|3244594|Superiority|||||||0.006||||||12 months|Chi-squared||||
1767570|NCT00023595|3244594|Superiority|||||||0.05||||||4 months|Chi-squared|P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767571|NCT00023595|3244595|Superiority|||||||0.44||||||36 months|Wilcoxon (Mann-Whitney)||||
1767572|NCT00023595|3244595|Superiority|||||||0.67||||||24 months|Wilcoxon (Mann-Whitney)||||
1767573|NCT00023595|3244595|Superiority|||||||0.94||||||12 months|Wilcoxon (Mann-Whitney)||||
1767574|NCT00023595|3244595|Superiority|||||||0.07||||||4 months|Wilcoxon (Mann-Whitney)||||
1767575|NCT00023595|3244595|Superiority|||||||0.19||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767576|NCT00023595|3244596|Superiority|||||||0.123||||||36 months|Chi-squared||||
1767577|NCT00023595|3244596|Superiority|||||||0.028||||||24 months|Chi-squared||||
1767578|NCT00023595|3244596|Superiority|||||||0.017||||||12 months|Chi-squared||||
1767579|NCT00023595|3244596|Superiority|||||||0.205||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767580|NCT00023595|3244597|Superiority|||||||0.94||||||36 months|Wilcoxon (Mann-Whitney)||||
1767581|NCT00023595|3244597|Superiority|||||||0.82||||||24 months|Wilcoxon (Mann-Whitney)||||
1767582|NCT00023595|3244597|Superiority|||||||0.62||||||12 months|Wilcoxon (Mann-Whitney)||||
1767583|NCT00023595|3244597|Superiority|||||||0.45||||||4 months|Wilcoxon (Mann-Whitney)||||
1767584|NCT00023595|3244597|Superiority|||||||0.38||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767585|NCT00023595|3244598|Superiority|||||||0.26||||||36 months|Wilcoxon (Mann-Whitney)||||
1767586|NCT00023595|3244598|Superiority|||||||0.009||||||24 months|Wilcoxon (Mann-Whitney)||||
1767587|NCT00023595|3244598|Superiority|||||||0.023||||||12 months|Wilcoxon (Mann-Whitney)||||
1767588|NCT00023595|3244598|Superiority|||||||0.005||||||4 months|Wilcoxon (Mann-Whitney)||||
1767589|NCT00023595|3244599|Superiority|||||||0.87||||||36 months|Wilcoxon (Mann-Whitney)||||
1767590|NCT00023595|3244599|Superiority|||||||0.89||||||24 months|Wilcoxon (Mann-Whitney)||||
1767591|NCT00023595|3244599|Superiority|||||||0.86||||||12 months|Wilcoxon (Mann-Whitney)||||
1767592|NCT00023595|3244599|Superiority|||||||0.13||||||4 months|Wilcoxon (Mann-Whitney)||||
1767593|NCT00023595|3244599|Superiority|||||||0.4||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767594|NCT00023595|3244600|Superiority|||||||0.097||||||36 months|Chi-squared||||
1767595|NCT00023595|3244600|Superiority|24 months||||||0.049|||||||Chi-squared||||
1767596|NCT00023595|3244600|Superiority|||||||0.003||||||12 months|Chi-squared||||
1767597|NCT00023595|3244600|Superiority|||||||0.05||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767598|NCT00023595|3244601|Superiority|||||||0.87||||||36 months|Wilcoxon (Mann-Whitney)||||
1767599|NCT00023595|3244601|Superiority|||||||0.6||||||24 months|Wilcoxon (Mann-Whitney)||||
1767600|NCT00023595|3244601|Superiority|||||||0.03||||||12 months|Wilcoxon (Mann-Whitney)||||
1767601|NCT00023595|3244601|Superiority|||||||0.87||||||4 months|Wilcoxon (Mann-Whitney)||||
1767602|NCT00023595|3244601|Superiority|||||||0.74||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767603|NCT00023595|3244602|Superiority|||||||0.044||||||36 months|Chi-squared||||
1767604|NCT00023595|3244602|Superiority|||||||0.007||||||24 months|Chi-squared||||
1767605|NCT00023595|3244602|Superiority|||||||0.011||||||12 months|Chi-squared||||
1767606|NCT00023595|3244602|Superiority|||||||0.004||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767607|NCT00023595|3244603|Superiority|||||||0.07||||||36 months|Wilcoxon (Mann-Whitney)||||
1767608|NCT00023595|3244603|Superiority|||||||0.64||||||24 months|Wilcoxon (Mann-Whitney)||||
1767609|NCT00023595|3244603|Superiority|||||||0.15||||||12 months|Wilcoxon (Mann-Whitney)||||
1767610|NCT00023595|3244603|Superiority|||||||0.57||||||4 months|Wilcoxon (Mann-Whitney)||||
1767611|NCT00023595|3244603|Superiority|||||||0.71||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767612|NCT00023595|3244604|Superiority|||||||0.83||||||36 months|Chi-squared||||
1767613|NCT00023595|3244604|Superiority|||||||0.065||||||24 months|Chi-squared||||
1767614|NCT00023595|3244604|Superiority|||||||0.003||||||12 months|Chi-squared||||
1767615|NCT00023595|3244604|Superiority|||||||0.051||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767616|NCT00023595|3244605|Superiority|||||||0.43||||||36 months|Wilcoxon (Mann-Whitney)||||
1767617|NCT00023595|3244605|Superiority|||||||0.32||||||24 months|Wilcoxon (Mann-Whitney)||||
1767618|NCT00023595|3244605|Superiority|||||||0.66||||||12 months|Wilcoxon (Mann-Whitney)||||
1767619|NCT00023595|3244605|Superiority|||||||0.42||||||4 months|Wilcoxon (Mann-Whitney)||||
1767620|NCT00023595|3244605|Superiority|||||||0.31||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767621|NCT00023595|3244606|Superiority||||||<|0.024||||||36 months|Chi-squared||||
1767622|NCT00023595|3244606|Superiority||||||<|0.001||||||24 months|Chi-squared||||
1767623|NCT00023595|3244606|Superiority||||||<|0.001||||||12 months|Chi-squared||||
1767624|NCT00023595|3244606|Superiority||||||<|0.001||||||4 months|Chi-squared||||
1767625|NCT00023595|3244607|Superiority|||||||0.79||||||36 months|Wilcoxon (Mann-Whitney)||||
1767626|NCT00023595|3244607|Superiority|||||||0.12||||||24 months|Wilcoxon (Mann-Whitney)||||
1767627|NCT00023595|3244607|Superiority|||||||0.17||||||12 months|Wilcoxon (Mann-Whitney)||||
1767628|NCT00023595|3244607|Superiority|||||||0.87||||||4 months|Wilcoxon (Mann-Whitney)||||
1767629|NCT00023595|3244607|Superiority|||||||0.36||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767630|NCT00023595|3244608|Superiority|||||||0.31||||||36 months|Chi-squared||||
1767631|NCT00023595|3244608|Superiority|||||||0.008||||||24 months|Chi-squared||||
1767632|NCT00023595|3244608|Superiority|||||||0.002||||||12 months|Chi-squared||||
1767633|NCT00023595|3244608|Superiority|||||||0.039||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767634|NCT00023595|3244609|Superiority|||||||0.9||||||36 months|Wilcoxon (Mann-Whitney)||||
1767635|NCT00023595|3244609|Superiority|||||||0.63||||||24 months|Wilcoxon (Mann-Whitney)||||
1767636|NCT00023595|3244609|Superiority|||||||0.69||||||12 months|Wilcoxon (Mann-Whitney)||||
1767637|NCT00023595|3244609|Superiority|||||||0.48||||||4 months|Wilcoxon (Mann-Whitney)||||
1767638|NCT00023595|3244609|Superiority|||||||0.82||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767639|NCT00023595|3244610|Superiority|||||||0.05||||||36 months|Chi-squared||||
1767640|NCT00023595|3244610|Superiority|||||||0.168||||||24 months|Chi-squared||||
1767641|NCT00023595|3244610|Superiority|||||||0.187||||||12 months|Chi-squared||||
1767642|NCT00023595|3244610|Superiority|||||||0.063||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767643|NCT00023595|3244611|Superiority|||||||0.29||||||36 months|Wilcoxon (Mann-Whitney)||||
1767644|NCT00023595|3244611|Superiority|||||||0.94||||||24 months|Wilcoxon (Mann-Whitney)||||
1767645|NCT00023595|3244611|Superiority|||||||0.78|||||||Wilcoxon (Mann-Whitney)||||
1767646|NCT00023595|3244611|Superiority|||||||0.61||||||4 months|Wilcoxon (Mann-Whitney)||||
1767647|NCT00023595|3244611|Superiority|||||||0.74||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767648|NCT00023595|3244612|Superiority|||||||0.079||||||36 months|Chi-squared||||
1767649|NCT00023595|3244612|Superiority|24 months||||||0.028|||||||Chi-squared||||
1767650|NCT00023595|3244612|Superiority|||||||0.002||||||12 months|Chi-squared||||
1767651|NCT00023595|3244612|Superiority|||||||0.31||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767652|NCT00023595|3244613|Superiority|||||||0.78|||||||Wilcoxon (Mann-Whitney)||||
1767653|NCT00023595|3244613|Superiority|||||||0.96|||||||Wilcoxon (Mann-Whitney)||||
1767654|NCT00023595|3244613|Superiority|||||||0.04||||||12 months|Wilcoxon (Mann-Whitney)||||
1767655|NCT00023595|3244613|Superiority|||||||0.62||||||4 months|Wilcoxon (Mann-Whitney)||||
1767656|NCT00023595|3244613|Superiority|||||||0.91||||||Baseline|Wilcoxon (Mann-Whitney)||||
1767657|NCT00023595|3244614|Superiority|||||||0.44||||||36 months|Chi-squared||||
1767658|NCT00023595|3244614|Superiority|||||||0.011||||||24 months|Chi-squared||||
1767659|NCT00023595|3244614|Superiority|||||||0.002||||||12 months|Chi-squared||||
1767660|NCT00023595|3244614|Superiority|||||||0.015||||||4 months|Chi-squared|H01 P-values were based on the Chi-Square test applied to maximum likelihood estimates derived from an adjusted mixed model.|||
1767661|NCT00023595|3244630|Superiority or Other (legacy)||Hazard Ratio (HR)|0.84||||0.018|2-Sided|95.0|0.73|0.97|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)||
1767662|NCT00023595|3244631|Superiority or Other (legacy)||Hazard Ratio (HR)|1.05||||0.717|2-Sided|95.0|0.83|1.32|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)||
1767663|NCT00023595|3244632|Superiority or Other (legacy)||Hazard Ratio (HR)|0.86||||0.108|2-Sided|95.0|0.72|1.03|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)||
1767664|NCT00023595|3244633|Superiority or Other (legacy)||Hazard Ratio (HR)|0.63|||<|0.001|2-Sided|95.0|0.55|0.73|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)||
1767665|NCT00023595|3244634|Superiority or Other (legacy)||Hazard Ratio (HR)|0.91||||0.414|2-Sided|95.0|0.73|1.13|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)||
1767666|NCT00023595|3244635|Superiority or Other (legacy)||Hazard Ratio (HR)|0.6|||<|0.001|2-Sided|95.0|0.51|0.71|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)||
1767667|NCT00023595|3244651|Superiority or Other (legacy)||Hazard Ratio (HR)|0.81||||0.002|2-Sided|95.0|0.71|0.93|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)||
1767668|NCT00023595|3244652|Superiority or Other (legacy)||Hazard Ratio (HR)|1.08||||0.401|2-Sided|95.0|0.89|1.31|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)||
1767669|NCT00023595|3244653|Superiority or Other (legacy)||Hazard Ratio (HR)|0.84||||0.03|2-Sided|95.0|0.71|0.98|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)||
1767670|NCT00023595|3244654|Superiority or Other (legacy)||Odds Ratio (OR)|1.37||||0.275|2-Sided|95.0|0.78|2.41|||Regression, Logistic||Odds Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)||
1767671|NCT00023595|3244655|Superiority or Other (legacy)||Odds Ratio (OR)|3.19||||0.008|2-Sided|95.0|1.35|7.52|||Regression, Logistic||Odds Ratio is for (H01: Medication +CABG) versus (H01: Medication)||
1767672|NCT00023595|3244656|Superiority or Other (legacy)||Hazard Ratio (HR)|1.0||||0.98|2-Sided|95.0|0.79|1.26|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)||
1767673|NCT00023595|3244657|Superiority or Other (legacy)||Hazard Ratio (HR)|0.72|||<|0.001|2-Sided|95.0|0.64|0.82|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)||
1767674|NCT00023595|3244658|Superiority or Other (legacy)||Hazard Ratio (HR)|0.74|||<|0.001|2-Sided|95.0|0.64|0.85|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)||
1767675|NCT00023595|3244659|Superiority or Other (legacy)||Hazard Ratio (HR)|0.81||||0.05|2-Sided|95.0|0.66|1.0|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)||
1767676|NCT00023595|3244660|Superiority or Other (legacy)||Hazard Ratio, log|0.79||||0.006|2-Sided|95.0|0.66|0.93|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)||
1767677|NCT00023595|3244661|Superiority or Other (legacy)||Hazard Ratio (HR)|0.99||||0.9|2-Sided|95.0|0.84|1.17|||Log Rank||Hazard Ratio is for (H02: Medication + CABG + SVR) versus (H02: Medication + CABG)||
1767678|NCT00023595|3244662|Superiority or Other (legacy)||Hazard Ratio (HR)|0.84||||0.02|2-Sided|95.0|0.73|0.97|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)||
1767679|NCT00023595|3244663|Superiority or Other (legacy)||Hazard Ratio (HR)|0.86||||0.12|2-Sided|95.0|0.72|1.04|||Log Rank||Hazard Ratio is for (H01: Medication +CABG) versus (H01: Medication)||
1767680|NCT00023452|3244669|Non-Inferiority or Equivalence|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood’s formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.19|||||1-Sided|95.0||0.06|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.||
1767681|NCT00023452|3244670|Superiority or Other||||||<|0.0001|||||||Chi-squared||||
1767682|NCT00023452|3244671|Superiority or Other||||||<|0.001|||||||Chi-squared||||
1767683|NCT00023452|3244673|Superiority or Other|||||||0.22|||||||Chi-squared||||
1767684|NCT00023452|3244674|Superiority or Other|||||||0.59|||||||Chi-squared|||Grade 4 Drug Toxicity|
1767685|NCT00023452|3244674|Superiority or Other|||||||0.24|||||||Chi-squared|||Grade 3 Drug Toxicity|
1767686|NCT00023452|3244675|Superiority or Other|||||||0.02|||||||Chi-squared||||
1767687|NCT00023452|3244676|Non-Inferiority or Equivalence|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood’s formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.25|||||1-Sided|95.0||0.03|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.||
1767688|NCT00023452|3244677|Non-Inferiority or Equivalence|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood’s formula and a two-sided 95% CI was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Rate|-0.21|||||1-Sided|95.0||0.04|||||The difference in cumulative TB disease rate is the percentage in the 3RPT/INH arm minus the percentage in the 9INH arm.||
1767689|NCT00023452|3244678|Non-Inferiority or Equivalence|The noninferiority test statistic was based on the difference of the nonparametric Kaplan-Meier estimators. The asymptotic variance of the test statistic was obtained through Greenwood’s formula and a two-sided 95% confidence interval (CI) was constructed for the difference. If the upper bound of the CI was smaller than the noninferiority margin 0.75%, then the null hypothesis would be rejected and noninferiority could be claimed.|Difference in Cumulative TB Disease Rate|-0.24|||||1-Sided|95.0||0.01|||||The difference in cumulative TB disease rate is the rate in the 3RPT/INH arm minus the rate in the 9INH arm.||
1767690|NCT00023309|3244681|Superiority or Other|||||||0.0913|||||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196|
1767691|NCT00023309|3244682|Superiority or Other|||||||0.0157|||||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196|
1767692|NCT00023309|3244683|Superiority or Other|||||||0.0049|||||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196|
1767693|NCT00023309|3244684|Superiority or Other|||||||0.0325|||||||Fisher Exact|||Null hypothesis: there is no difference in treatment effect at week 196|
1767694|NCT00023309|3244685|Superiority or Other|||||||0.0294|||||||Fisher Exact|||Null hypothesis: there is no difference in the treatment effect between the two groups|
1767695|NCT00014911|3244702|Superiority or Other||Odds Ratio (OR)|58.0|||||2-Sided|95.0|42.0|63.0|||||||
1767696|NCT00014911|3244703|Superiority or Other||Odds Ratio (OR)|28.0|||||2-Sided|95.0|16.0|44.0|||||||
1767697|NCT00014911|3244704|Superiority or Other||Odds Ratio (OR)|44.0|||||2-Sided|95.0|30.0|61.0|||||||
1767698|NCT00004978|3244720|Superiority or Other||Hazard Ratio (HR)|0.96||||0.74|2-Sided|95.0|0.76|1.22|||Regression, Cox||||
1767699|NCT00004978|3244721|Superiority or Other|||||||0.97|||||||Chi-squared||||
1767700|NCT00004978|3244722|Superiority or Other||Hazard Ratio (HR)|1.23||||0.003|2-Sided|95.0|1.07|1.41|||Regression, Cox||HR (IL-2 vs control) for first grade 4 event, ITT analysis.||
1767701|NCT00004978|3244723|Superiority or Other||Hazard Ratio (HR)|0.94||||0.07|2-Sided|95.0|0.88|1.0|||Regression, Cox|Hazard ratio (rIL-2 vs. no rIL-2) for first change in antiretroviral treatment.|||
1767702|NCT00004978|3244725|Superiority or Other||Mean Difference (Final Values)|159.0|||||2-Sided|95.0|145.0|174.0|||||treatment difference (rIL2 - no rIL2) estimated from a longitudinal model that considers CD4+ measured at followup visits||
1767703|NCT00004978|3244726|Superiority or Other||Hazard Ratio (HR)|0.91||||0.41|2-Sided|95.0|0.73|1.14|||Regression, Cox||||
1767704|NCT00004978|3244727|Superiority or Other||Hazard Ratio (HR)|0.9||||0.42|2-Sided|95.0|0.69|1.17|||Regression, Cox||||
1767705|NCT00004978|3244728|Superiority or Other||Hazard Ratio (HR)|0.94||||0.62|2-Sided|95.0|0.74|1.2|||Regression, Cox||||
1767706|NCT00004978|3244729|Superiority or Other||Hazard Ratio (HR)|0.94||||0.55|2-Sided|95.0|0.75|1.16||P-value is 2-sided using an alpha of .05.|Regression, Cox|Hazard ratio is from unadjusted proportional hazards regression model.|HR is for rIL-2 vs control.||
1767707|NCT00021541|3244732|Other|||||||0.66|||||||Repeated measures ANOVA|||Post hoc test: placebo group F=0.19|
1767708|NCT00021541|3244732|Other|||||||0.015|||||||Repeated measures ANOVA|||Post hoc test: tipifarnib group F=7.40|
1767709|NCT00021541|3244732|Superiority|||||||0.012|||||||Repeated measures ANOVA||||
1767710|NCT00013611|3244739|Superiority or Other||Mean Difference (Final Values)|53.0|Standard Error of the Mean|6.5|<|0.001|2-Sided|95.0|40.3|65.7|||Mixed Models Analysis||||
1767711|NCT00013611|3244740|Superiority or Other||Hazard Ratio (HR)|1.1||||0.35|2-Sided|95.0|0.9|1.34|||Regression, Cox||||
1767712|NCT00013611|3244741|Superiority or Other||Hazard Ratio (HR)|0.73||||0.1|2-Sided|95.0|0.51|1.06|||Regression, Cox|Stratification by CD4+ stratum and country of randomization.|||
1767713|NCT00013611|3244742|Superiority or Other||Hazard Ratio (HR)|1.06||||0.73|2-Sided|95.0|0.77|1.44|||Regression, Cox|Stratification by CD4+ stratum and country of randomization.|||
1767714|NCT00013611|3244743|Superiority or Other||Hazard Ratio (HR)|0.91||||0.47|2-Sided|95.0|0.7|1.18|||Regression, Cox|Stratification by CD4+ count stratum (50-199 or 200-299) and country of randomization.||Null hypothesis was that event rates in two groups are equal. Study was designed with 80%, two-sided alpha=.05, assuming a 28% reduction in the hazard of opportunistic disease or death.|
1767715|NCT00010803|3244744|Superiority or Other||Treatment X Time interaction|-0.002||||0.65|2-Sided|95.0|-0.009|0.005|||Mixed Models Analysis|||Linear mixed models comparing rates of change in global cognition scores (z-scores) by treatment group|
1767716|NCT00010803|3244745|Non-Inferiority or Equivalence|Previously provided|Hazard Ratio (HR)|1.0||||0.98|2-Sided|95.0|0.8|1.25|||Log Rank|||Total CHD and CVD combined|
1767717|NCT00010803|3244745|Non-Inferiority or Equivalence|Previously provided|Cox Proportional Hazard|1.12||||0.42|2-Sided|95.0|0.84|1.5|||Log Rank|||Incident CVD|
1767718|NCT00010803|3244745|Non-Inferiority or Equivalence|Previously provided|Hazard Ratio (HR)|0.87||||0.59|2-Sided|95.0|0.52|1.45|||Log Rank|||Incident TIA|
1767719|NCT00010803|3244745|Non-Inferiority or Equivalence|Previously provided|Hazard Ratio (HR)|0.87||||0.25|2-Sided|95.0|0.52|1.45|||Log Rank|||Incident Stroke|
1767720|NCT00010803|3244745|Non-Inferiority or Equivalence|Previously Provided|Hazard Ratio (HR)|0.91||||0.48|2-Sided|95.0|0.71|1.18|||Log Rank|||Incident CHF|
1767721|NCT00010803|3244745|Non-Inferiority or Equivalence|Previously provided|Hazard Ratio (HR)|0.94||||0.66|2-Sided|95.0|0.72|1.23|||Log Rank|||Incident CHD|
1767722|NCT00010803|3244745|Non-Inferiority or Equivalence|Previously Provided|Hazard Ratio (HR)|0.84||||0.32|2-Sided|95.0|0.61|1.18|||Log Rank|||Incident Angina|
1767723|NCT00010803|3244745|Non-Inferiority or Equivalence|Previously provided|Hazard Ratio (HR)|1.12||||0.54|2-Sided|95.0|0.79|1.58|||Log Rank|||Incident Myocardial Infarction|
1767724|NCT00010803|3244745|Non-Inferiority or Equivalence|Previously provided|Hazard Ratio (HR)|1.06||||0.78|2-Sided|95.0|0.7|1.62|||Log Rank|||Atherosclerotic CHD mortality|
1767725|NCT00010803|3244745|Non-Inferiority or Equivalence|Previously provided|Hazard Ratio (HR)|1.04||||0.7|2-Sided|95.0|0.85|1.27|||Log Rank|||Total Mortality|
1767726|NCT00010803|3244746|Non-Inferiority or Equivalence|Previously provided|Hazard Ratio (HR)|1.12||||0.21|2-Sided|95.0|0.94|1.33|||Log Rank|Time to dementia in Ginkgo vs placebo groups. The Cox proportional hazards model was used to compute hazard ratios and log-rank tests.||The null hypothesis is that the instantaneous hazard rate for Ginkgo biloba and placebo are the same. Assumptions were based on 4%/yr dementia and 6%/yr mortality and dropout combined. A sample size of 3000 with an average follow up of 5 years resulted in 96% power to detecting a 30% reduction in the rate of dementia at a 2-sided significance level of 0.5.|
1767727|NCT00007475|3244754|Superiority or Other||Proportion with reduced proteinuria|0.6363|Standard Error of the Mean|0.0698|<|0.0001|2-Sided|95.0|0.3079|0.8907||Exact binomial test of proportion of participants exhibiting reduction in proteinuria (see definition below), under null hypothesis that the overall proportion is zero.|Exact binomial test|Tested under null hypothesis that the overall proportion is zero.|Proportion event definition: exhibiting reduction in proteinuria post-cyclophosphamide (complete- [urine protein {UP} <0.3] or or partial-remission [between 0.3 & 2.0, inclusive], limited response [UP between 2.0 & 3.5] yet no relapse [UP 3.5+]).|No groups compared, yet null hypothesis: pooled proportion = 0, tested using counts pooled across baseline FPF assay-availability groups (7 across 3 arms) excluding 4 non-completers (yielding 7/11 with event below). Given the modest group-specific sample sizes and tendency for zero outcomes to be observed in a group, we employ exact binomial 95% confidence intervals using the method of Clopper and Pearson (1934; calculated along with corresponding tests using Michael Fay's exactci package in R).|
1767728|NCT00007345|3244759|Superiority or Other||||||<|0.01||||||An exact Cochran-Armitage trend test was used to compare the distributions. In view of the large number of tests performed, we only refer to those with P-values <0.01 as statistically significant, with those for which 0.01 <P< 0.05 considered trends.|Cochran-Armitage trend test||||
1767729|NCT00006305|3244769|Superiority or Other||Risk Difference (RD)|-0.024||||0.13||95.0|-0.06|0.012||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of Death/MI/Stroke for Insulin Sensitizing glycemic control strategy compared with Insulin Providing glycemic control strategy||
1767730|NCT00006305|3244769|Superiority or Other||Risk Difference (RD)|-0.013||||0.7|2-Sided|95.0|-0.049|0.022||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of Death/MI/Stroke for Revascularization compared with Medical Therapy||
1767731|NCT00006305|3244770|Superiority or Other||Risk Difference (RD)|-0.003||||0.89|2-Sided|95.0|-0.029|0.022||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of all-cause mortality for Insulin Sensitizing glycemic control strategy compared with Insulin Providing glycemic control strategy||
1767732|NCT00006305|3244770|Superiority or Other||Risk Difference (RD)|-0.005||||0.97|2-Sided|95.0|-0.031|0.02||A separate test with alpha=0.05 was conducted for each treatment comparison of the main effects in the 2x2 factorial design.|Log Rank||Risk difference of all-cause mortality for Revascularization compared with Medical therapy||
1767733|NCT00006289|3244771|Superiority or Other|||||||0.0058|||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).|
1767734|NCT00006289|3244772|Superiority or Other|||||||0.0058|||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).|
1767735|NCT00006289|3244773|Superiority or Other|||||||0.0058|||||||t-test, 1 sided|||Data from 16 patients is analyzed using one-sided paired t-test without breaking treatment code (Drug A or B, without knowing which drug is Neurotropin or Placebo) to determine if (1) the study should be terminated (if 0.0058 ≤ p), (2) the study should be terminated with rejection of the null hypothesis that there are no differences between Drug A and Drug B (p ≥ 0.9), or (3) the study will be continued to obtain the total of 42 patients (0.0058 ≤ p ≤ 0.9).|
1767736|NCT00006170|3244780|Non-Inferiority or Equivalence|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.046|||||||Regression, Logistic||||
1767737|NCT00006170|3244780|Non-Inferiority or Equivalence|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.45|||||||Regression, Logistic||||
1767738|NCT00006170|3244780|Non-Inferiority or Equivalence|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.006|||||||Regression, Logistic||||
1767739|NCT00006170|3244781|Non-Inferiority or Equivalence|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.08|||||||Regression, Logistic||||
1767740|NCT00006170|3244781|Non-Inferiority or Equivalence|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.053|||||||Regression, Logistic||||
1767741|NCT00006170|3244781|Non-Inferiority or Equivalence|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.|||||<|0.001|||||||Regression, Logistic||||
1767742|NCT00006170|3244782|Non-Inferiority or Equivalence|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.07|||||||Regression, Logistic||||
1767743|NCT00006170|3244782|Non-Inferiority or Equivalence|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.25|||||||Regression, Logistic||||
1767744|NCT00006170|3244782|Non-Inferiority or Equivalence|Power was determined using a log-rank statistic for comparing 2 survival curves, with a 2-sided alpha level of 0.05 and 40% as the reference from which differences were computed.||||||0.001|||||||Regression, Logistic||||
1767745|NCT00004980|3244820|Superiority or Other|||||||0.01||||||a priori threshold for statistical significance = .05|Chi-squared||||
1767746|NCT00004980|3244821|Superiority or Other||Median Difference (Final Values)|-0.949|Standard Error of the Mean|0.524||0.001||95.0|-1.45|-0.44||A priori threshold for statistical significance was .05|t-test, 2 sided|degrees of freedom = 46|||
1767747|NCT00004980|3244822|Superiority or Other||Mean Difference (Final Values)|1.27|Standard Error of the Mean|0.327||0.002||95.0|0.507|2.03||a priori threshold for statistical significance was .05|t-test, 2 sided|degrees of freedom = 48||null hypothesis is that the groups are the same|
1767748|NCT00004980|3244823|Superiority or Other||Mean Difference (Final Values)|-2.76|Standard Error of the Mean|0.514||0.005||95.0|-4.65|-0.86||a priori threshold for statistical significance was .05|t-test, 2 sided|degree of freedom = 48|||
1767749|NCT00004732|3244824|Superiority or Other||Hazard Ratio (HR)|1.35|||||2-Sided|95.0|0.82|2.23|||||HR (95% CI) for WOMEN CAS vs CEA (adjusted for age and symptomatic status)||
1767750|NCT00004732|3244825|Superiority or Other||Hazard Ratio (HR)|1.11|||||2-Sided|95.0|0.81|1.51|||||HR (95% CI) adjusted for age, sex and symptomatic status||
1767751|NCT00001959|3244849|Superiority or Other|||||||0.16|||||||Kruskal-Wallis|||H0: Proteinuria during baseline and treatment periods are same|
1767752|NCT00001959|3244850|Superiority or Other||||||<|0.01|||||||Wilcoxon (Mann-Whitney)|||H0: GFR Decrease during baseline period and treatment period are same|
1767753|NCT00000392|3244856|Superiority or Other|||||||0.18|||||||ANOVA||||
1767754|NCT00001723|3244863|Superiority or Other|||||||0.007|||||||ANCOVA||||
1767755|NCT00001656|3244866|Superiority or Other|||||||0.73|||||||Wilcoxon (Mann-Whitney)||||
1767756|NCT00001656|3244868|Superiority or Other|||||||0.76|||||||t-test, 2 sided||||
1767757|NCT00001656|3244869|Superiority or Other|||||||0.96|||||||t-test, 2 sided||||
1767758|NCT00001656|3244870|Superiority or Other|||||||0.11|||||||ANCOVA|Covariate is baseline score|||
1767759|NCT00001656|3244871|Superiority or Other|||||||0.27|||||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate|
1767760|NCT00001656|3244872|Superiority or Other|||||||0.72|||||||ANCOVA|||Analysis of covariance with baseline score as covariate|
1767761|NCT00001656|3244873|Superiority or Other|||||||0.59|||||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate|
1767762|NCT00001656|3244874|Superiority or Other|||||||0.19|||||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate|
1767763|NCT00001656|3244875|Superiority or Other|||||||0.35|||||||ANCOVA|||Analysis of covariance with baseline score as covariate|
1767764|NCT00001656|3244876|Superiority or Other|||||||0.21|||||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate|
1767765|NCT00001656|3244877|Superiority or Other|||||||0.04|||||||ANCOVA|Covariate is baseline score||Analysis of covariance with baseline score as covariate|
1767766|NCT00000378|3244918|Superiority or Other||||||<|0.05||||||actual calculation|Regression, Logistic|||logistic regression and mixed effects model|
1767767|NCT00000620|3244920|Superiority or Other||Hazard Ratio (HR)|0.94||||0.3|2-Sided|95.0|0.85|1.05||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.|||
1767768|NCT00000620|3244921|Superiority or Other||Hazard Ratio (HR)|0.92||||0.32|2-Sided|95.0|0.79|1.08||P-value is adjusted for interim monitoring. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||Recruitment for the Glycemia Trial was designed to enroll 5800 participant to have 87% power to detect a 20% reduction in the rate of MCE for patients in the fenofibrate group as compared with the placebo group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 2.4% per year in the placebo group, and a planned average follow-up of approximately 5.6 years.|
1767769|NCT00000620|3244922|Superiority or Other||Hazard Ratio (HR)|0.59||||0.01|2-Sided|95.0|0.39|0.89||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.|||
1767770|NCT00000620|3244923|Superiority or Other||Hazard Ratio (HR)|0.88||||0.2|2-Sided|95.0|0.73|1.06||P-value is adjusted for interim monitoring. A priori significance level was 0.05.|Regression, Cox|Adjustment for the seven clinical center networks and presence of clinical cardiovascular disease at baseline as pre-specified in the study protocol.||Recruitment for the Blood PressureTrial was designed to enroll 4200 participant to have 94% power to detect a 20% reduction in the rate of MCE for patients in the intensive-therapy group as compared with the standard-therapy group, assuming a two-sided alpha level of 0.05, a primary-outcome rate of 4% per year in the standard-therapy group, and a planned average follow-up of approximately 5.6 years.|
1767771|NCT00000620|3244924|Superiority or Other||Hazard Ratio (HR)|1.19||||0.02|2-Sided|95.0|1.03|1.38||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|||Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.|
1767772|NCT00000620|3244925|Superiority or Other||Hazard Ratio (HR)|0.91||||0.12|2-Sided|95.0|0.81|1.03||P-value presented is not adjusted for multiple comparisons. A priori significance level was 0.05.|Regression, Cox|||Adjustment performed for the following pre-specified factors: sub-trial assignment (Blood Pressure Trial or Lipid Trial), assignment to intensive BP group in BP Trial, assignment to fenofibrate group in Lipid Trial, the seven clinical center networks, and presence of clinical cardiovascular disease at baseline.|
1767773|NCT00004412|3244941|Superiority or Other||Mean Difference (Final Values)|0.5||||0.05|2-Sided||||||Fisher Exact|||Percentage of ulcers undergoing partial and complete healing compared at 12 weeks. Mean Ulcer areas were calculated utilizing computerized planimetry, ulcer area tracings, and photography for baseline and 12 weeks and compared between the two study Arms.|
